Sanofi (SNY) 2025 20-F flags Dupixent concentration and US–EU drug pricing pressures
Filing Impact
Filing Sentiment
Form Type
20-F
Sanofi has filed its annual report on Form 20-F, outlining 2025 results and a wide range of risks that could affect future performance. The company prepares its consolidated accounts under IFRS and emphasizes that forward-looking statements are highly uncertain.
Sanofi spent €7,842 million on research and development in 2025, equal to 18.0% of net sales, while its key drug Dupixent generated net sales of €15,714 million, or 36.0% of total net sales. The United States represented 50.8% of net sales, underscoring exposure to US pricing and policy changes.
The report details major risks: product liability litigation, tightening global regulation, intellectual property challenges, cyber and data-privacy threats, complex manufacturing and supply chains, climate and geopolitical disruptions, and heavy dependence on a few blockbuster products. Sanofi highlights growing pressure from US and European pricing policies, including an MFN agreement with the US government and the Inflation Reduction Act, as significant long-term headwinds.
Positive
- None.
Negative
- None.
Insights
Sanofi’s 20-F stresses concentration in Dupixent and mounting US/EU pricing risk.
Sanofi presents a business increasingly driven by a few assets, especially Dupixent, which delivered
The company also underscores a structurally tougher pricing environment. It notes a voluntary MFN agreement with the US government and the broader MFN demonstration models plus the Inflation Reduction Act’s Medicare negotiations. With the US representing
Sanofi continues to invest heavily, spending
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_________________________
FORM 20-F
(Mark One)
REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
Or | |
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
For the fiscal year ended December 31 , 2025
Or
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
Or | |
SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
Date of event requiring this shell company report
For the transition period from to
Commission File Number: 001-31368
_______________________________
(Exact name of registrant as specified in its charter)
N/A
(Translation of registrant’s name into English)
(Jurisdiction of incorporation or organization)
(Address of principal executive offices)
________________________
(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)
________________________
Securities registered or to be registered pursuant to Section 12(b) of the Act:
Title of each class: | Trading Symbol | Name of each exchange on which registered: |
American Depositary Shares, each representing one half of one ordinary share, par value €2 per share | ||
* |
Securities registered or to be registered pursuant to Section 12(g) of the Act: None
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None
The number of outstanding shares of each of the issuer’s classes of capital or common stock as of December 31, 2025 was:
Ordinary shares: 1,219,427,096
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ☐.
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934. Yes ☐ No ☒.
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes ☒ No ☐.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of
Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or an emerging growth company. See
definition of “large accelerated filer”, “accelerated filer” or “emerging growth company” in Rule 12b-2 of the Exchange Act.
☒ | Accelerated filer | ☐ | Non-accelerated filer | ☐ | Emerging growth company |
If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected
not to use the extended transition period for complying with any new or revised financial accounting standards(1) provided pursuant to Section 13(a) of the
Exchange Act. ☐
(1) The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting
Standards Codification after April 5, 2012.
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal
control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared
or issued its audit report ☒
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the
filing reflect the correction of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive- based compensation
received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
U.S. GAAP | ☐ | as issued by the International Accounting Standards Board | ☒ | Other | ☐ |
If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected
to follow. Item 17. ☐ Item 18. ☐
If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒ .
*Not for trading but only in connection with the registration of American Depositary Shares representing such ordinary shares.
Presentation of financial
and other information
The consolidated financial statements contained in this annual report on Form 20-F have been prepared in accordance with
International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB) and with
IFRS as endorsed by the European Union (EU), as of December 31, 2025.
Unless otherwise indicated or the context requires otherwise, the terms “Sanofi,” the “Company,” the “Group,” “we,” “our,” or “us”
refer to Sanofi and its consolidated subsidiaries.
All references herein to “United States” or “US” are to the United States of America, references to “dollars” or “$” are to the
currency of the United States, references to “France” are to the Republic of France, and references to “euro” and “€” are to the
currency of the European Union member states (including France) participating in the European Monetary Union.
As of the date of this annual report on Form 20-F, all commercial trademarks mentioned here are protected, and are trademarks
of Sanofi and/or its subsidiaries, with the exception of:
•trademarks used or that may be or have been used under license by Sanofi and/or its affiliates;
•trademarks sold by Sanofi and/or its affiliates to a third party; and
•other third party trademarks.
Not all trademarks related to products under development have been authorized as of the date of this annual report by the
relevant health authorities.
The data relating to market shares and ranking information for medicines and vaccines, in particular as presented
in “Item 4. Information on the Company — B. Business Overview — B.5. Markets — B.5.1. Marketing and distribution,” are based
primarily on sales data excluding vaccines and in constant euros (unless otherwise indicated) on a September 2025 moving
annual total (MAT) basis. The data are primarily from an IQVIA local sales audit, supplemented by country-specific sources.
Product indications described in this annual report are composite summaries of the major indications approved in the product’s
principal markets. Not all indications are necessarily available in each of the markets in which the products are approved. The
summaries presented herein for the purpose of financial reporting do not substitute for careful consideration of the full labeling
approved in each market.
Cautionary statement regarding
forward-looking statements
This annual report contains certain forward-looking statements within the meaning of applicable federal securities law, including
the Private Securities Litigation Reform Act of 1995, as amended. We may also make written or oral forward-looking statements in
our periodic reports to the Securities and Exchange Commission on Form 6-K, in our annual report to shareholders, in our offering
circulars and prospectuses, in press releases and other written materials and in oral statements made by our officers, directors or
employees to third parties. Examples of such forward-looking statements include:
•projections of operating revenues, net income, business net income, earnings per share, business earnings per share, capital
expenditures, cost savings, restructuring costs, positive or negative synergies, dividends, capital structure or other financial
items or ratios;
•statements of our profit forecasts, trends, business strategies, plans, objectives or goals, including those relating to products,
clinical studies, regulatory approvals and competition; and
•statements about our future events and economic performance or that of France, the United States or any other countries in
which we operate.
Words such as “believe,” “anticipate,” “can,” “contemplate,” “could,” “plan,” “expect,” “intend,” “is designed to,” “may,” “might,”
“potential,” “objective,” "attempt," “target,” “estimate,” “project,” "strategy," "strive," "desire," “predict,” “forecast,” “ambition,”
“guideline,” "seek," “should,” “will,” "goal," or the negative of these and similar expressions are intended to identify forward-
looking statements but are not the exclusive means of identifying such statements.
Forward-looking statements involve inherent, known and unknown risks, uncertainties and assumptions associated with, for
example, the regulatory, economic, financial and competitive environment, including authorities’ decisions regarding whether
and when to approve a product candidate, political pressure in the United States to mandate lower drug prices including “most
favored nation” pricing for State Medicaid programs, and other factors that could cause actual future results to differ materially
from those expressed or implied in the forward-looking statements.
These risks, uncertainties and assumptions include risk factors, which could also affect future results and cause actual results to
differ materially from those contained in any forward-looking statements, and which include those discussed under “Item 3. Key
Information — D. Risk Factors.” Additional risks that are unknown at this time or that are currently considered immaterial by the
Group, may have the same unfavorable effect and investors may lose all or part of their investment.
As a result of these factors, we cannot assure you that the forward-looking statements in this annual report will prove to be
accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the
significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or
warranty by us or any other person that we will achieve our objectives and plans in any specified time frame or at all. Moreover,
forward-looking statements speak only as of the date they are made. Other than required by law, we do not undertake any
obligation to update them in light of new information, future developments or otherwise, except as required by law. These
forward-looking statements are based upon information, assumptions and estimates available to us as of the date of this annual
report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or
incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all
potentially available relevant information. In light of these risks, uncertainties and assumptions, you should not place undue
reliance on any forward-looking statements contained herein.
You should read this annual report and the documents that we reference in this annual report and have filed as exhibits
completely and with the understanding that our actual future results may be materially different from what we expect. We qualify
all of our forward-looking statements by these statements.
Abbreviations
Principal abbreviations used in the Annual Report on Form 20-F
ADR | American Depositary Receipt |
ADS | American Depositary Share |
AFEP | Association française des entreprises privées (French Association of Large Companies) |
AI | Artificial Intelligence |
AMF | Autorité des marchés financiers (the French market regulator) |
ANDA | Abbreviated New Drug Application |
BLA | Biologic License Application |
BMS | Bristol-Myers Squibb |
CEO | Chief Executive Officer |
CER | Constant exchange rates |
CGU | Cash generating unit |
CHMP | Committee for Medicinal Products for Human Use |
COPD | Chronic Obstructive Pulmonary Disease |
COVALIS | Sanofi committee for internal occupational exposure limits (Comité des Valeurs Limites Internes Sanofi) |
CSR | Corporate Social Responsibility |
CVR | Contingent value right |
EFPIA | European Federation of Pharmaceutical Industries and Associations |
EMA | European Medicines Agency |
ERT | Enzyme Replacement Therapy |
EU | European Union |
FCF | Free cash flow |
FDA | US Food and Drug Administration |
GAVI | Global Alliance for Vaccines and Immunisation |
GBU | Global Business Unit |
GenAI | Generative artificial intelligence |
GERS | Groupement pour l'Élaboration et la Réalisation de Statistiques (French pharmaceutical industry statistics partnership) |
GHG | Greenhouse gas |
GLP-1 | Glucagon-like peptide-1 |
GMP | Good manufacturing practices |
Hib | Hemophilus influenzae type b |
HSE | Health, Safety and Environment |
IASB | International Accounting Standards Board |
IFRIC | International Financial Reporting Interpretations Committee |
IFRS | International Financial Reporting Standards |
IPV | Inactivated polio vaccine |
IRA | US Inflation Reduction Act |
ISIN | International Securities Identification Number |
J-MHLW | Japanese Ministry of Health, Labor and Welfare |
LoE | Loss of Exclusivity |
LSD | Lysosomal storage disorder |
MEDEF | Mouvement des entreprises de France (French business confederation) |
MFN | Most Favored Nation (US) |
mRNA | messenger RNA |
MS | Multiple sclerosis |
NASDAQ | National Association of Securities Dealers Automated Quotations |
NDA | New Drug Application |
NYSE | New York Stock Exchange |
ODD | Orphan Drug Designation |
OECD | Organisation for Economic Co-operation and Development |
PBM | Pharmacy Benefit Manager |
PhRMA | Pharmaceutical Research and Manufacturers of America |
PMDA | Pharmaceuticals and Medical Devices Agency (Japan) |
PTE | Patent Term Extension |
QIV | Quadrivalent influenza vaccine |
R&D | Research and development |
RSV | Respiratory Syncytial Virus |
SA | Société anonyme (French public limited corporation) |
SEC | US Securities and Exchange Commission |
SPC | Supplementary Protection Certificate |
TRIBIO | Sanofi Committee for Biological Risk Prevention (Biosafety, Biosecurity, Biosurveillance) |
TSR | Total shareholder return |
UNICEF | United Nations Children’s Emergency Fund |
US | United States of America |
WHO | World Health Organization |
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TABLE OF CONTENTS | |
PART I | 1 | |||
Item 1. | IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS | 1 | ||
Item 2. | OFFER STATISTICS AND EXPECTED TIMETABLE | 1 | ||
Item 3. | KEY INFORMATION | 1 | ||
A. Selected Financial Data | 1 | |||
B. Capitalization and Indebtedness | 1 | |||
C. Reasons for Offer and Use of Proceeds | 1 | |||
D. Risk Factors | 1 | |||
Item 4. | INFORMATION ON THE COMPANY | 17 | ||
A. History and Development of the Company | 17 | |||
B. Business Overview | 18 | |||
C. Organizational Structure | 52 | |||
D. Property, Plant and Equipment | 53 | |||
E. R&D Appendices | 56 | |||
Item 4.A | UNRESOLVED STAFF COMMENTS | 58 | ||
Item 5. | OPERATING AND FINANCIAL REVIEW AND PROSPECTS | 58 | ||
A. Operating results | 58 | |||
B. Liquidity and Capital Resources | 76 | |||
C. Research and development, patents and licenses, etc. | 81 | |||
D. Trend information | 81 | |||
E. Critical accounting estimates | 81 | |||
Item 6. | DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES | 82 | ||
A. Directors and Senior Management | 82 | |||
B. Compensation | 114 | |||
C. Board Practices | 138 | |||
D. Employees | 145 | |||
E. Share Ownership | 147 | |||
F. Disclosure of action to recover erroneously awarded compensation | 149 | |||
Item 7. | MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS | 150 | ||
A. Major Shareholders | 150 | |||
B. Related Party Transactions | 151 | |||
C. Interests of Experts and Counsel | 151 | |||
Item 8. | FINANCIAL INFORMATION | 152 | ||
A. Consolidated Financial Statements and Other Financial Information | 152 | |||
B. Significant Changes | 154 | |||
Item 9. | THE OFFER AND LISTING | 155 | ||
A. Offer and Listing Details | 155 | |||
B. Plan of Distribution | 155 | |||
C. Markets | 155 | |||
D. Selling Shareholders | 155 | |||
E. Dilution | 155 | |||
F. Expenses of the Issue | 155 | |||
Item 10. | ADDITIONAL INFORMATION | 156 | |
A. Share Capital | 156 | ||
B. Memorandum and Articles of Association | 156 | ||
C. Material Contracts | 160 | ||
D. Exchange Controls | 160 | ||
E. Taxation | 160 | ||
F. Dividends and Paying Agents | 164 | ||
G. Statement by Experts | 164 | ||
H. Documents on Display | 165 | ||
I. Subsidiary Information | 165 | ||
J. Annual Report to Security Holders | 165 | ||
Item 11. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK | 166 | |
Item 12. | DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES | 169 | |
PART II | 171 | ||
Item 13. | DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES | 171 | |
Item 14. | MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS | 171 | |
Item 15. | CONTROLS AND PROCEDURES | 172 | |
Item 16A. | AUDIT COMMITTEE FINANCIAL EXPERT | 173 | |
Item 16B. | CODE OF ETHICS | 173 | |
Item 16C. | PRINCIPAL ACCOUNTANTS’ FEES AND SERVICES | 173 | |
Item 16D. | EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES | 173 | |
Item 16E. | PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS | 174 | |
Item 16F. | CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT | 174 | |
Item 16G. | CORPORATE GOVERNANCE | 175 | |
Item 16H. | MINE SAFETY DISCLOSURE | 176 | |
Item 16I. | DISCLOSURES REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS | 176 | |
Item 16J. | INSIDER TRADING POLICIES | 176 | |
Item 16K. | CYBERSECURITY | 177 | |
PART III | 179 | ||
Item 17. | FINANCIAL STATEMENTS | 179 | |
Item 18. | FINANCIAL STATEMENTS | 179 | |
Item 19. | EXHIBITS | 179 | |
SANOFI FORM 20-F 2025 | 1 |
PART I |
ITEM 1. Identity of Directors, Senior Management and Advisers |
Part I
Item 1. Identity of Directors, Senior Management and Advisers
N/A
Item 2. Offer Statistics and Expected Timetable
N/A
Item 3. Key Information
A. Selected financial data
N/A
B. Capitalization and indebtedness
N/A
C. Reasons for offer and use of proceeds
N/A
D. Risk factors
Important factors that could cause actual financial, business, research, or operating results to differ materially from expectations
are disclosed in this annual report, including without limitation the following risk factors. Investors should carefully consider all the
information set forth in the following risk factors and elsewhere in this document before deciding to invest in any of the
Company’s securities. In addition to the risks listed below, we may be subject to other material risks that as of the date of this
report are not currently known to us or that we deem immaterial at this time.
Risks relating to legal and regulatory matters
Product liability claims could adversely affect our business, results of operations and financial condition
Product liability is a significant risk for any pharmaceutical company, given that liability claims relating to our industry are
unforeseeable by nature. The evolving regulatory environment worldwide (the ever-more stringent regulatory requirements
applicable to the pharmaceutical industry, plus more stringent data, quality, and supply obligations) clearly impacts our potential
liability, and we may incur different liability claims to what we have handled in the past, in terms of their nature, scope, and level.
For a description of the regulatory environment in which we operate, refer to “Item 4. Information on the Company - B. Business
Overview - B.5.3. Regulatory framework.” Substantial damages have been awarded by some jurisdictions and/or settlements
agreed – notably in the United States and other common law jurisdictions – against pharmaceutical companies based on claims
for injuries allegedly caused using their products. Such claims can also lead to product recalls, withdrawals, or declining sales,
and/or be accompanied by consumer fraud claims by customers, third-party payers seeking reimbursement of the cost of the
product and/or other claims, including potential civil or criminal governmental actions.
We are currently defending several product liability claims (see Note D.22.a. to our consolidated financial statements included at
Item 18. of this annual report) notably with respect to Taxotere, Zantac, Talc products, and Depakine, and there can be no
assurance that we will be successful in defending these claims, or that we will not face additional claims in the future.
Establishing the full side effect profile of a pharmaceutical drug goes beyond data derived from preapproval clinical studies
which may only involve several hundred to several thousand patients. Routine review and analysis of the continually growing
body of post-marketing safety data and clinical studies provide additional information – for example, potential evidence of rare,
population-specific, or long-term adverse events or of drug interactions that were not observed in preapproval clinical studies.
This causes labeling to evolve over time following interactions with regulatory authorities, which may include restrictions of
therapeutic indications, new contraindications, warnings, or precautions and occasionally even the suspension or withdrawal of a
marketing authorization. Following any of these events, pharmaceutical companies can face significant product liability claims.
Furthermore, we commercialize several devices (some of which use new technologies) which, if they malfunction, could cause
unexpected damage and lead to product liability claims (see also “ — Breaches of data security, disruptions of information
technology systems and cyber threats could result in financial, legal, competitive, operational, business, or reputational harm”
below).
2 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 3. Key Information |
Although we continue to insure a portion of our product liability with third-party carriers, product liability coverage is increasingly
difficult and costly to obtain, particularly in the United States. In the future, it is possible that self-insurance may become the sole
commercially reasonable means available for managing the financial risk associated with product liability in our pharmaceuticals
and vaccines businesses (see “Item 4. — B.8. Insurance and risk coverage”). In cases where we self-insure, the legal costs that we
would bear for handling such claims, and potential damage awards to be paid to claimants, could have a negative impact on our
financial condition. Due to insurance conditions, even when we have insurance coverage, recoveries from insurers may not be
totally successful due to market-driven insurance limitations and exclusions. Moreover, insolvency of an insurer could affect our
ability to recover claims on policies for which we have already paid a premium.
Product liability claims, regardless of their merits or the ultimate success of our defense, are costly, divert management’s
attention, may harm our reputation, and can impact the demand for our medicines or vaccines and generate speculative news
flows and/or rumors relating to such claims. Substantial product liability claims could materially adversely affect our business,
results of operations and financial condition, and/or may have an impact on market perception of our company and negatively
affect our stock price.
Claims and investigations relating to ethics and business integrity, competition law, marketing practices,
pricing, human rights of workers and other legal matters could adversely affect our business,
results of operations and financial condition
Our industry is heavily regulated and legal requirements vary from country to country, and new requirements are imposed on our
industry from time to time. Governments and regulatory authorities around the world have been strengthening implementation
and enforcement activities in recent years, including in relation to anti-bribery, anti-corruption, and ethical requirements with
respect to medical and scientific research, interactions with healthcare professionals and payers, and respect for the human
rights of workers.
We have adopted a Code of Conduct that requires employees to comply with applicable laws and regulations, as well as the
specific principles and rules of conduct set forth in the Code. We also have policies and procedures designed to help ensure that
we, our officers, employees, agents, intermediaries and other third parties comply with applicable laws and regulations (including
but not limited to the US Foreign Corrupt Practices Act (FCPA), the UK Bribery Act, the OECD Anti-Bribery Convention, the
French Anti-Corruption measures law (Sapin II), the French duty of vigilance law and other anti-bribery laws and regulations).
Notwithstanding these efforts, failure to comply with laws and regulations (including because of a business partner’s breach) may
occur and could result in liabilities for us and/or our management.
Sanofi and certain of its subsidiaries could become the subject of investigations or proceedings by various government entities or
could face audits and/or litigation, including allegations of corruption, claims related to employment matters, patent and
intellectual property disputes, consumer law claims and/or competition law and tax audits. We are currently the target of several
lawsuits relating to pricing and marketing practices (including, for example, “whistleblower” and 340B drug pricing program
litigation in the United States), which we are vigorously defending. With respect to tax issues, the complexity of the fiscal
environment is such that the ultimate resolution of any tax matter may result in payments that are greater or less than the
provisions we have booked. See “Item 8. Financial Information — A. Information on Legal or Arbitration Proceedings” and
Note D.22. to our consolidated financial statements included at Item 18. of this annual report. In addition, responding to such
investigations is costly and may divert management’s attention from our business.
Unfavorable outcomes in any of these matters, or in similar matters that may arise in the future, could preclude the
commercialization of our medicines and vaccines, harm our reputation, negatively affect the profitability of existing medicines
and vaccines and subject us to substantial fines, punitive damages, penalties and injunctive or administrative remedies, possible
reputational harm, potential imposition of additional regulatory controls, monitoring or self-reporting obligations, or exclusion
from government reimbursement programs or markets, all of which could have a material adverse effect on our business, results
of operations or financial condition.
The unpredictability of these proceedings could lead Sanofi, after consideration of all relevant factors, to enter into settlement
agreements to settle certain claims. Such settlements may involve significant monetary payments and/or potential criminal
penalties, may include admissions of wrongdoing and may require entering into a Corporate Integrity Agreement (CIA), a
Deferred Prosecution Agreement or similar agreement (in the United States or elsewhere), agreements intended to regulate
company behavior for a specified number of years.
Our business activities are subject to extensive and significant government legislation and regulations,
compliance with which is often costly. Our business, results of operations and/or financial condition
could be adversely affected if we fail to comply with them, obtain and maintain the required approvals,
anticipate legal changes or developments and/or adapt to changes in applicable law
All aspects of our business, including research and development, manufacturing, marketing, reimbursement, pricing, and sales,
are subject to extensive legislation and governmental regulation (see also "—Research, clinical development and regulatory
approval processes present significant risks to our pipeline success and portfolio renewal" below).
Compliance with applicable legislation and regulations has been and may be costly, and such costs may increase in future. For
example, post marketing regulatory requirements have increased the costs associated with maintaining marketing authorizations.
To monitor our compliance with applicable law, the FDA, EMA, WHO and comparable national agencies in other jurisdictions
routinely conduct regulatory inspections of our facilities, distribution centers, commercial activities, and development centers
(including hospitals), the number of which will increase in the context of new product launches, and such agencies may identify
potential deficiencies that we must adequately address. More generally, if we fail to adequately respond to regulatory inspection
observations identified during an inspection or fail to comply with applicable regulatory requirements (including within the
SANOFI FORM 20-F 2025 | 3 |
PART I |
ITEM 3. Key Information |
targeted timeline), we could be subject to enforcement, remedial and/or other actions by the FDA (such as warning letter,
injunction, seizure or cease and desist order), the EMA or other regulatory authorities, and we may also ultimately face potential
supply continuity consequences. For example, in January 2025 the FDA issued an inspection-related warning letter related to
certain GMP practices at our Framingham facility.
The evolving regulatory environment presents significant operational challenges across multiple jurisdictions. In the European
Union (EU) the increasing fragmentation of national law due to potentially inconsistent transposition of EU directives into EU
member state national law may result in complex compliance burdens, delayed market access, and heightened operational costs
across the environmental, data protection, and pharmaceutical domains, which would make operating in Europe more costly and
slower than in other regions. Concurrently, the dynamic changes in the US regulatory and policy landscape coupled with
institutional changes, including shifts in US vaccine policy, at regulatory agencies under the Department of Health and Human
Services (such as the Centers for Disease Control and Prevention and FDA) may lead to uncertainties with changing expectations
from the authorities, including revisiting certain previous decisions approving medicines or vaccines. Significant changes in
expectations, regulations and regulatory guidance could adversely impact our timelines for product approvals, regulatory
processes and potentially our ability to bring critical medicines or vaccines to patients in a timely manner.
For example, the pharmaceutical industry has experienced challenges due to the implementation of the new European Union
regulations for Medical Devices (EU MDR) and for In-Vitro Diagnostic Devices (IVDR), which entered into force in May 2021 and
May 2022, respectively. In October 2024, the European Parliament adopted a resolution for a revision of these regulations with a
view to addressing challenges, in particular obstacles associated with the implementation of the EU MDR and IVDR; however, the
outcome of that resolution is uncertain at this stage.
More broadly, government disruptions (including shutdowns, furloughed workers, reduced or frozen federal funding, the
medium- and long-term impacts thereof, or the de-prioritization of essential regulatory functions such as marketing application
reviews, facility inspections, safety monitoring, and routine health authority support) pose substantial risks to availability of
governmental authorities and approval schedules, ultimately threatening timely patient access to essential medicines and
vaccines across affected markets, which could have a material adverse effect on our business, results of operations or financial
condition.
In addition, we have an obligation to monitor and report adverse events and safety signals. To comply with these duties, we must
regularly train our employees and certain third parties (such as external sales forces and distributor employees) on regulatory
matters, including on pharmacovigilance. If we fail to train these people, or fail to train them appropriately, or if they do not
comply with regulatory and contractual requirements, we may be exposed to the risk that safety events are not reported, or not
reported in a timely manner, in breach of our reporting obligations.
For information about risks related to changes (i) in proprietary rights rules and regulations, see “— We rely on our patents and
other proprietary rights to provide exclusive rights to market certain of our medicines and vaccines. If such patents and other
rights were limited, invalidated, or circumvented, our financial results could be adversely affected” below; and (ii) in
environmental rules and regulations, see “—Management of the historical contamination related to our past industrial activities
could adversely impact our results of operations and reputation” below.
In addition, changes in applicable laws and the costs of compliance with such laws and regulations could have an adverse effect
on our business, results of operations and/or financial condition.
Changes in tax laws or regulations or their interpretation or exposures to additional tax liabilities around the world could
negatively impact our operating results. Changes to tax laws or regulations may occur at any time, and any related expense or
benefit recorded may be material to the fiscal quarter and year in which the law change is enacted or becomes effective. As a
result of the 2024 presidential and legislative elections in the United States, changes to applicable laws and regulations that have
been announced, proposed, and/or adopted, or could be made or expanded in the future, may result in new or expanded trade
restrictions by the United States and/or other countries, including, but not limited to, tariffs or import taxes being applied to
imported goods and services which could affect our operations and our exports into the United States. For example, the One Big
Beautiful Bill Act was signed into law on July 4, 2025 and made significant changes to US federal income tax laws, including,
among other things, the reintroduction of immediate expensing of domestic research and development expenditures, the
restoration of 100% bonus depreciation and changes to the limitation on business interest expense deductions. Other countries
may implement trade restrictions and/or retaliatory measures as well. Any such trade restrictions or measures could affect our
operations, our exports into the United States and other countries and/or our supply chains. Further significant modifications to
tax legislation are also expected in some of the markets where we operate, such as France and the United States. All these
elements could negatively impact our business, results or operations and/or financial condition.
Furthermore, most of the jurisdictions in which we operate have double tax treaties with other foreign jurisdictions, which provide
a framework for mitigating the impact of double taxation on our revenues and capital gains. However, the outcome of those
mechanisms developed to resolve such conflicting claims can in some circumstances be uncertain and can be expected to be
very lengthy. Provisions for tax contingencies are made based on experience, interpretations of tax law, and judgments about
potential actions by tax authorities. However, due to the complexity of tax contingencies, the ultimate resolution of any tax
matter may result in payments materially different from the amounts accrued.
We rely on our patents and other proprietary rights to provide exclusive rights to market certain
of our medicines and vaccines. If such patents and other rights were limited, invalidated, or
circumvented, our financial results could be adversely affected
Through patent and other proprietary rights, such as data exclusivity or supplementary protection certificates in Europe, we hold
exclusivity rights for several of our research-based medicines and vaccines. However, the protection that we can obtain varies in
its duration and scope. Furthermore, patents and other proprietary rights do not always provide effective protection for our
4 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 3. Key Information |
medicines and vaccines. We cannot be certain that we will obtain adequate patent protection for new medicines and vaccines
and technologies in important markets or that such protections, once granted, will last as long as originally anticipated.
For example, governmental authorities are increasingly looking to facilitate generic and biosimilar competition for existing
medicines and vaccines through new regulatory proposals intended to achieve, or resulting in, changes to the scope of patent or
data exclusivity rights and using accelerated regulatory pathways for generic and biosimilar approvals. At the EU level, the
proposed wide-ranging revision of the general pharmaceutical legislation may pose downside risks to innovation and
competitiveness in Europe, primarily due to amendments to regulatory exclusivities, the reduction of intellectual property (IP)
protections, and a stricter incentives framework for orphan medicinal products (OMPs). Such regulatory proposals could
adversely affect product exclusivity periods and otherwise make commercialization in the EU more burdensome.
Moreover, manufacturers of generics and biosimilars are increasingly seeking to challenge patent validity or coverage before the
patents expire, and manufacturers of biosimilars or interchangeable versions of the medicines are seeking to have their version
approved before the exclusivity period ends. Furthermore, in an infringement suit against a third party, we may not prevail, and
the decision rendered may not conclude that our patent or other proprietary rights are valid, enforceable, or infringed. Our
competitors may also avoid our patents. Even in cases where we ultimately prevail in an infringement claim, legal remedies
available for harm caused to us by such third party's infringement may be inadequate to make us whole. Moreover, a successful
result against a competing product for a given patent or in a specific country is not necessarily predictive of our future success
against another competing product or in another country because of local variations in the patents and patent laws.
In addition, if we lose patent protection because of an adverse court decision or a settlement, we face the risk that government
and private third-party payers and purchasers of medicines and vaccines may claim damages alleging they have over-reimbursed
or overpaid for a drug.
We also rely on unpatented proprietary technology, know-how, trade secrets and other confidential information, which we seek
to protect through various measures, including confidentiality agreements with licensees, employees, third-party collaborators,
and consultants who may have access to such information. If these agreements are breached or our other protective measures
should fail, then our contractual or other remedies may not be adequate to cover our losses.
In certain cases, to terminate or avoid patent litigation we or our collaboration partners may be required to obtain licenses from
the holders of third-party intellectual property rights. Any payments under these licenses may reduce our profits from such
medicines and vaccines and we may not be able to obtain these licenses on favorable terms or at all.
Third parties may also request a preliminary or permanent injunction in a country from a court of law to prevent us from
marketing a medicine or vaccine if they consider that we infringe their patent rights in that country. For example, Sanofi is or was
party to patent infringement proceedings in several countries initiated against us and Regeneron by Amgen Inc. relating to
Praluent in which Amgen Inc. requested injunctive relief (see Note D.22.b. to our consolidated financial statements included at
Item 18. of this annual report). If third parties obtain a preliminary or permanent injunction or if we fail to obtain a required license
for a country where valid third-party intellectual property rights as confirmed by a court of law exist, or if we are unable to alter
the design of our technology to fall outside the scope of third-party intellectual property rights, we may be unable to market
some of our medicines and vaccines in certain countries, which may limit our profitability and have a negative impact on our
financial results.
In addition, the pursuit of valid business opportunities may require us to challenge intellectual property rights held by others that
we believe were improperly granted, including through negotiation and litigation, and such challenges may not always be
successful. Third parties may claim that our medicines and vaccines infringe one or more patents owned or controlled by them.
Claims of intellectual property infringement can be costly and time-consuming to resolve, may delay or prevent product
launches, and may result in significant royalty payments or damages.
Furthermore, some countries may consider granting a compulsory license to a third party to use patents protecting an
innovator’s product, which limits the value of the patent protection granted to such products.
We have increased the proportion of biological therapeutics in our pipeline relative to traditional small-molecule medicines.
Typically, the development, manufacture, sale, and distribution of biological therapeutics is complicated by third-party
intellectual property rights (otherwise known as freedom to operate (FTO) issues), to a greater extent than for the small molecule
therapeutics, because of the types of patents allowed by national patent offices. Further, our ability to successfully challenge
third-party patent rights is dependent on the legal interpretation and case law of national courts. In addition, we expect to face
increasing competition from biosimilars in the future. With regulatory pathways available in the United States and Europe for
biosimilar drug approval, biosimilars can be a threat to the exclusivity of any biological therapeutics we sell or may market in the
future and can pose the same issues as the small-molecule generic threat described above. If a biosimilar version of one of our
medicines were to be approved, it could reduce our sales and/or profitability.
We currently hold trademark registrations and have trademark applications pending in many jurisdictions, any of which may be
the subject of a governmental or third-party objection, which could prevent the maintenance or issuance of the trademark. As
our medicines and vaccines mature, our reliance on our trademarks and trade dress to differentiate us from our competitors
increases and, as a result, our business could be adversely affected if we are unable to prevent third parties from adopting,
registering, or using trademarks and trade dress that infringe, dilute, or otherwise violate our rights.
If our patents and/or proprietary rights to our medicines and vaccines were limited or circumvented, our financial results could be
adversely affected.
SANOFI FORM 20-F 2025 | 5 |
PART I |
ITEM 3. Key Information |
Failure to comply with data ethics and privacy regulations could adversely affect our business
and reputation
We operate in an environment that relies on the collection, processing, analysis, and interpretation of large sets of patients’ and
other individuals’ personal data, and the operation of our business requires data to flow freely across borders of numerous
countries.
The legal and regulatory environment of data privacy is diversified, with regional legislation such as the General Data Protection
Regulation (GDPR) in Europe, the Personal Information Protection Law (PIPL) in China, and other significant privacy legislation,
including the California Consumer Privacy Act (CCPA) in the United States. The regulatory landscape continues to evolve with
increasingly fragmented requirements across jurisdictions, creating uncertainty and challenges to companies’ ability to put in
place operational policies and procedures to comply with applicable rules and regulations. These changes could result in
increased operational risk by limiting or preventing data transfer across borders, which may materially negatively impact our
activities, such as our ability to share data when conducting clinical studies (see also “— Data sovereignty regulations could
significantly impact Sanofi's global operations and strategic initiatives” below). Any breach of such regulations could also incur
financial penalties and reputational harm.
Our increasing reliance on third-party partnerships and service providers introduces additional risks, as data breaches affecting
these partners could have direct implications for our operations and reputation.
Furthermore, the increasing volume of data processed and advances in new technologies, such as artificial intelligence (AI),
introduce new complexities in ensuring responsible data use, requiring sophisticated governance frameworks and specialized
expertise to effectively manage these emerging technologies while maintaining compliance and ethical standards. Failure in our
data governance and ethical use of personal data could affect our business and reputation. (see "— We may fail to develop or
take advantage of digitalization and prioritizing data as an organizational asset" below).
Risks relating to our business
Research, clinical development and regulatory approval processes present significant risks to our
pipeline success and portfolio renewal
Our future success is highly dependent on our pipeline of new products. Researching and developing new medicines or vaccines
is a costly, lengthy, and highly uncertain process and we have faced and may in the future face setbacks or failures in connection
with these and other aspects of our efforts to maintain or expand our pipeline of new products. To succeed in the highly
competitive biopharmaceutical industry, we must commit substantial resources each year to research and develop new
medicines and vaccines to compensate for decreasing sales of medicines or vaccines facing patent expiration and termination of
regulatory data exclusivity, introduction of lower-priced generics and biosimilars, or competition from new launches by
competitors that are perceived as being comparable or superior in efficacy or safety to our therapies. We must pursue both
research and early-, mid- and late-stage development to achieve a sustainable and well-balanced portfolio. In 2025, we spent
€7,842 million on research and development, representing 18.0% of our net sales. As part of an update to our strategy, we
announced in October 2023 our intent to increase our investment in research and development. Failure to invest with the
appropriate balance in the right technology platforms, disease areas, medicine or vaccine classes, geographic markets, and
licensing or acquisition opportunities could adversely impact the productivity of our internal pipeline. We may fail to improve our
development productivity sufficiently to sustain our pipeline.
We are researching and developing medicines with several potential indications, intended to address unmet medical needs in
markets with a low penetration of novel advanced therapies, or where no effective treatment is currently approved. We focus our
R&D strategy on medicines in immunology, rare diseases, neurology, and selectively in oncology. In 2021, Sanofi acquired
Translate Bio to accelerate the deployment of mRNA technology for the development of new vaccines, including for seasonal
influenza, and beyond vaccines, medicines where there is a strong unmet medical need. However, mRNA technology is still in its
early days and there can be no assurance that this technology will be able to produce strong results with an acceptable safety
profile. (see also “— We may fail to successfully identify external business opportunities or realize the anticipated benefits from
our strategic investments or divestments” below).
The competitive landscape includes a high level of uncertainty including because numerous companies are working on or may be
evaluating similar targets to us. A medicine or vaccine considered as promising at the beginning of its development may become
less so if (among other things) a competitor addressing the same unmet need reaches the market earlier.
Over these research and development cycles, usually spanning several years, there is a substantial risk at each stage of
development that we will not achieve our goals of safety and/or efficacy and that we will decide to abandon a medicine or
vaccine in which we have invested substantial amounts of money and human resources. There can be no assurance that any of
our pipeline projects will be proven safe or effective or will receive marketing approval (see "Item 4. Information on the Company
— B.4. Global research & development").
Studies are increasingly designed with clinical endpoints of superiority, which means that failure to achieve those endpoints could
damage the medicine or vaccine's outlook and our overall development program. For instance, in 2025 we discontinued further
development on a vaccine candidate for extraintestinal pathogenic E. coli after indication of insufficient efficacy, and the SP0125
program for the prevention of respiratory syncytial virus-related disease in toddlers.
Interim results of our clinical trials do not necessarily predict final results, and product candidates believed to have performed
satisfactorily in preclinical studies and early clinical trials can nonetheless fail or obtain mixed results at a later stage, or fail to
obtain marketing approval. For instance, in May 2025, we announced mixed results for the itepekimab COPD (chronic obstructive
pulmonary disease) Phase 3 studies.
6 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 3. Key Information |
Participants in clinical trials of our products and product candidates or individuals using drugs similar to our product candidates
may suffer serious and unexpected adverse events or side effects that could delay or terminate clinical trial programs, require
additional or longer trials to gain approval, or result in clinical holds imposed by regulatory authorities pending receipt of
additional data.
We rely heavily on independent clinical investigators, contract research organizations (CROs), and other third-party service
providers to assist us in managing, monitoring, and otherwise carrying out our clinical trials; co-development partners can also be
involved. If our third-party service providers or co-development partners cannot adequately and timely fulfill their obligations to
us, or if the quality and accuracy of our clinical trial data are compromised due to their failure to adhere to our protocols or
regulatory requirements, or if they fail to meet deadlines, our development plans and regulatory reviews for marketing approvals
may be delayed or terminated, which would harm our business and negatively impact our stock price.
Also we have faced and may in the future face difficulties in recruiting and enrolling patients for clinical trials.
Decisions concerning the studies to be carried out can have a significant impact on the marketing strategy for a given medicine
or vaccine. Multiple in-depth studies, usually in Phase 4, can demonstrate that a medicine or vaccine has additional benefits,
thereby facilitating the marketing, but such studies are expensive and time consuming and may delay the medicine or vaccine's
submission to regulatory authorities for approval.
Obtaining a marketing authorization for a medicine or vaccine is a long and highly regulated process requiring us to present
extensive documentation and data to the relevant regulatory authorities. The regulatory approval pathway for our product
candidates may be uncertain, complex, expensive, and lengthy, and approval is never certain. Each regulatory authority may
impose its own requirements that can evolve over time, and regulatory authorities may change requirements for the approval of a
product candidate even after reviewing and providing comments or advice on a protocol for a clinical study. Also we may not be
able to successfully address all the comments received from regulatory authorities. For instance, in December 2025, the FDA
issued a complete response letter (CRL) on the new drug application for tolebrutinib to treat non-relapsing secondary
progressive multiple sclerosis (nrSPMS) in adult patients. Each regulatory authority may also delay or decline granting approval
regardless of whether a medicine or vaccine has already been approved in another country.
The FDA, EMA, or other regulatory authorities may disagree with our trial design, our interpretation of data from preclinical and
clinical studies, or the conclusions reached from our data. Further, regulatory authorities may not accept or agree with our
assumptions, estimates, calculations, or conclusions, or may interpret or weigh the importance of data differently, which may
delay, limit, impede or prevent regulatory approval. Also we may be unable to establish clinically meaningful endpoints that
regulatory authorities consider appropriate, which could delay, limit, impede or prevent advancement or marketing approval of
our product candidates.
If the results of our clinical trials are inconclusive or if there are safety concerns or serious adverse events associated with our
product candidates, we may fail to obtain or face delay in obtaining marketing approval; the approval for indications or patient
population may not be as broad as intended; the regulatory authorities may not accept the labeling claims that we believe would
be desirable for successful commercialization; the approved labeling may include significant use or distribution restrictions or
safety warnings, contraindications, or other limiting statements; and additional clinical trials may be required to support approval
or we may be subject to additional post-marketing testing requirements. Regulatory authorities may also withdraw or suspend
their approval of the drug or impose restrictions on its distribution in the form of a modified risk evaluation and mitigation
strategy (REMS) plan. Anticipated and/or observed safety concerns from novel immunomodulatory therapies may require
proactive and targeted risk mitigation to maintain positive benefit-risk for clinical trial participants and if mitigation efforts do not
adequately mitigate such concerns could result in clinical holds, delays or termination of clinical trials, increased regulatory
scrutiny, or an unfavorable reassessment of the benefit-risk profile including at the marketing approval stage, any of which could
adversely affect our pipeline development and results of operations.
In addition, following (or in some cases in parallel with) the marketing authorization, a dossier is also submitted to governmental
agencies and/or national or regional third-party payers for review. Health technology assessment bodies evaluate evidence on
the value of the new medicine or vaccine, assess the medical need it serves, and provide recommendations on the corresponding
appropriate reimbursement. Such analyses may require additional studies, including comparative studies, which may effectively
delay marketing, change the population for which the new medicine or vaccine is intended, and add costs to the development.
Our continuous investments in our research and development pipeline, and in launches of newly registered molecules, could
therefore result in increased costs without a proportionate increase in revenues, which would negatively affect our operating
results and profitability.
Furthermore, there can be no assurance that all medicines or vaccines approved or launched will achieve commercial success.
Also product extensions or additional indications may not be approved, limiting our ability to maximize the commercial potential
of existing medicines or vaccines.
Even after a medicine or vaccine reaches the market, certain developments following regulatory approval may reduce demand
for them. In particular, results from clinical studies following approval (including studies undertaken as post-approval
commitments) and information gathered through post-marketing surveillance, including relating to safety, efficacy or tolerability
of pharmaceuticals in general, have the potential to raise concerns among some prescribers and patients, may change the
benefit-risk assessment, may negatively affect the potential for commercialization, and may increase the risk of being required to
withdraw a product from the market by regulatory authorities, including due to FDA approval withdrawal on an expedited basis,
any of which could negatively affect sales or lead to increased volatility in market reaction.
SANOFI FORM 20-F 2025 | 7 |
PART I |
ITEM 3. Key Information |
The pricing and reimbursement of our medicines and vaccines are negatively affected by increasing cost
containment pressures and major policy shifts
The commercial success of our products is negatively affected by escalating pricing and access pressures across all markets due,
inter alia, to:
•Increasing price interdependency and international price referencing (IRP) pressure/shifts between countries:
–introduction of "most favored nation" (MFN) tying US reimbursement prices to a benchmark, comprising the G7 nations
(excluding the US) plus Denmark and Switzerland, giving rise to the potential for global rebalancing of drug prices between
the US and other countries, with an impact on launch sequencing and pricing corridors.
•Tighter cost-containment policies imposed by governments and other payers around the world:
–US federal government drug price controls, including MFN policy and Medicare drug price negotiations under the Inflation
Reduction Act (IRA);
–requirements for greater transparency around drug pricing and drug development costs;
–mandatory price cuts, renegotiations, industry payback and rebates;
–delisting from reimbursement and restrictions on the label population;
–access restrictions for high-priced innovative medicines;
–prescribing guidelines and binding medicine utilization controls;
–greater use of tendering and centralized procurement (national/regional/class-wide level);
–cross-country cooperation in price negotiations, contracting or procurement;
–shifting of the payment burden to US patients and access disruptions through copay accumulator and maximizer programs
as well as alternative funding programs;
–more aggressive formulary utilization management controls (including stepped therapy, strict prior authorization criteria,
formulary exclusions) by US insurers and pharmacy benefits managers (PBMs); and
–discriminatory and non-transparent pricing and procurement policies (e.g. government procurement restrictions, import
bans, and threats of pharma-specific tariffs) that favor domestic pharmaceutical companies.
•More complex health technology assessment (HTA) processes raising the bar for market entry, primarily in non-US markets:
–more stringent evidence and value requirements throughout the product lifecycle (e.g. comparative effectiveness, patient
preferences, real-world evidence, health economic modelling) by payers and HTA authorities;
–unreasonable thresholds for cost-effectiveness; and
–increasingly restrictive HTA decisions with significant variation across markets.
•Increased generic and biosimilar competition, accelerating price erosion while generating savings for future innovation:
–accelerated generics/biosimilars entry triggered by new US legislation and expected revised EU pharma legislation;
–next generation biosimilars coming to the market across major therapeutic areas;
–potential savings from increased biosimilar use, which are expected to be a cumulative $290 billion globally from 2023 to
2027 and could reach $383 billion, according to IQVIA’s recent Global Use of Medicines report; and
–evolving regulatory landscapes to support interchangeability (e.g. in the US and EU) and pharmacy substitution (e.g. in the
EU Nordic countries, Germany and France).
We are facing heightened policy uncertainty triggered by new policies in the US and in Europe, requiring us to rethink our global
launch sequencing, pricing and access strategies.
On December 19, 2025, we signed a voluntary MFN agreement with the US government ensuring that state Medicaid programs
can access certain of our medicines at the same prices available to other high-income nations. Although we secured a three-year
tariff exemption and near-term clarity during the three-year duration of the MFN agreement, uncertainty remains regarding final
MFN implementation rules and their potential implications for future product launches. In December, the US government also
announced three new MFN pricing demonstration models: Generating cost Reductions for US Medicaid (GENEROUS) a voluntary
program through which pharmaceutical manufacturers (including those, like Sanofi, that entered into MFN agreements) opt in to
providing MFN pricing to state Medicaid programs; Global Benchmark for Efficient Drug Pricing (GLOBE); and Guarding US
Medicare Against Rising Drug Costs (GUARD). GLOBE and GUARD are mandatory models for manufacturers who have not opted
in to participating in the GENEROUS program and cover both Medicare Part B (GLOBE) and Part D (GUARD). Each of these
payment demonstrations is set to last for a period of five years, whereas Sanofi's MFN agreement is only for a duration of three
years. While Sanofi’s MFN agreement is voluntary and time-bound, these commitments along with the broader context of the
payment demonstration programs described above could significantly constrain our commercial flexibility and may limit our
ability to launch certain new products in specific countries or markets where local pricing conditions would otherwise require
different pricing strategies. If we are unable to achieve acceptable pricing terms in a given market that are consistent with our
MFN obligations, we may be forced to delay or forgo product launches in that market entirely, thereby reducing potential
revenues and limiting patient access to our medicines and vaccines. Furthermore, the precedent established by voluntary MFN
arrangements and the evolving regulatory and political environment, particularly in major markets, may increase pressure on
pharmaceutical companies to accept MFN or comparable pricing mechanisms on a more widespread basis in the future, whether
through voluntary agreements, regulatory requirements, or legislative mandates. The implementation of MFN provisions also
presents operational complexities and may create downward pressure on prices across our portfolio, limiting our ability to
capture the value of innovation. Any of these factors could have a material adverse effect on our business, results of operations,
financial condition, and our ability to bring innovative treatments to patients worldwide.
In the United States, which accounted for 50.8% of our net sales in 2025, we are navigating a transformative landscape driven by
the combined and ripple effects of the MFN and the IRA pricing policies. While MFN focuses on Medicaid, future launches and the
direct-to-patient market, the IRA primarily targets Medicare high-expenditure medicines. The IRA continues to mandate price
negotiations for Medicare drugs, progressively expanding the number of drugs subject to negotiation each year from 10 Part D
drugs in 2026 to 20 per year from 2029 onward, with the exception of orphan drugs (regardless of the number of indications)
8 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 3. Key Information |
under the One Big Beautiful Bill Act. 2025 negotiation rounds have shown substantial price reductions, with increasing downward
pressure on US drug pricing over time. While Sanofi's current US portfolio has limited government channel exposure and Dupixent
is not currently expected to be impacted by IRA until 2031, this evolving legislation may impact our revenue growth and influence
our portfolio strategy in the medium to long term.
Furthermore, in commercial channels, we continue to face intensifying pricing pressure and gross-to-net (GTN) erosion from
payers and pharmacy benefit managers (PBMs) (i.e. formulary exclusions, tighter utilization management, higher rebate demands,
accumulator/maximizer programs). With the three largest group purchasing organizations (GPOs) - Ascent, Zinc and Emisar - now
covering approximately 85% of prescription drug claims, consolidation has led to greater PBM GPO negotiating power with drug
manufacturers, thereby adversely impacting our sales.
In the US, we may also face rapidly shifting federal vaccine policy, healthcare funding cuts, supply chain challenges (due to high
dependency on API imports), and persistent trade and geopolitical tensions.
In Europe, regulatory changes, including EU Pharmaceutical Legislation reform, and EU HTA Regulation, are fundamentally
reshaping how medicines are valued, priced, and launched across Europe. This creates a more centralized and higher-risk access
environment, forcing companies to make strategic trade-offs between early broad market access and protecting global pricing
strategies. The proposed EU pharmaceutical legislation reform, expected in early 2026, aims to counterbalance MFN pressure
while ensuring Europe remains a viable launch region, though it introduces new market access challenges including reduced data
protection and potential forced launches in unprofitable markets. The EU HTA Regulation, effective since early 2025, centralizes
clinical assessment at the EU level while maintaining national pricing decisions. This introduces new timeline and resource
pressures, but offers potential for more harmonized patient access. The mandatory Joint Clinical Assessment has become
strategically critical for global evidence strategies.
Breaches of data security, disruptions of information technology systems and cyber threats could result
in financial, legal, competitive, operational, business, or reputational harm
Our business depends heavily on the use of interdependent information technology systems, including Internet-based systems
and digital tools. Certain key areas such as research and development, production and sales are largely dependent on our
information systems (including cloud-based computing) or those of third-party providers (including for the storage and transfer
of critical, confidential, sensitive, or personal information regarding our patients, clinical studies, vendors, customers, employees,
collaborators and others). We are therefore vulnerable to cybersecurity attacks and incidents, and misuse or manipulation of any
of these IT systems could result in exposure of confidential information or the modification of critical data.
We and our third-party service providers, suppliers, contract manufacturers, distributors or other contracting third parties use, to
the best of our ability, secure information technology systems for the protection of data and threat detection. Like many
companies, we may experience certain of the following events which pose a risk to the security and availability of these systems
and networks, and the confidentiality, integrity, and availability of our sensitive data: breakdown, outages, service disruption or
impairment, data loss or deterioration in the event of a system malfunction or increasing threat of data theft or corruption in the
event of a cyber-attack, security breach, industrial espionage attacks, insider threat attacks, cybercrimes, including state-
sponsored cybercrimes, malware, misplaced or lost data, programming or human errors or other similar events. Also, in the event
of an attack, regulatory and legislative frameworks worldwide (including in the United States and the European Union) related to
the financing of terrorism impose increasing restrictions on payments of ransom. As a result, our ability to recover the data might
be limited. Therefore, our business continuity could be at risk if we are unable to recover data through back-ups and restorations.
In addition, several existing and forthcoming rules and laws – including NIS2, the European Health Data Space (EHDS), the Data
Act, the Cyber Resilience Act and the AI Act – are changing privacy and cybersecurity compliance requirements, and creating
new potential enforcement risks.
We are increasingly using generative AI to enhance our business processes. Although we have set up a governance body to
control the AI initiatives taken on a company-wide scale and have made a generative AI charter available to all our employees,
this new technology, like other AI technology, entails risks linked to transparency, fairness, data privacy and confidentiality, eco-
responsibility, and cybersecurity. These risks could result in unintended consequences such as unethical practices, business and
reputational harm, cyber-attacks, and security breaches (see “— We may fail to develop or take advantage of digitalization and
prioritizing data as an organizational asset” below). Moreover, there is a global trend towards more comprehensive regulation of
AI that may require us to modify existing or adopt new compliance procedures, or developments that could impact the
effectiveness of and our ability to use AI tools.
Each of these events could negatively impact important processes, such as scientific research and clinical studies, the submission
of outcomes to health authorities for marketing authorizations, the functioning of production processes and the supply chain,
compliance with legal requirements, trade secrets, security strategies and other key activities, including Sanofi employees’ ability
to communicate between themselves as well as with third parties (see also “— Product liability claims could adversely affect our
business, results of operations and financial condition” above). This could result in material financial, legal, competitive,
operational, business, or reputational harm.
Although we maintain relevant insurance coverage, this insurance may not be sufficiently available in the future to cover the
financial, business, or reputational losses that may result from an interruption or breach of our systems. For example, certain types
of cyber-attacks could be considered as an act of war subject to insurance exclusion.
SANOFI FORM 20-F 2025 | 9 |
PART I |
ITEM 3. Key Information |
The manufacture of our medicines and vaccines is technically complex, and supply interruptions,
product recalls or inventory losses caused by unforeseen events may reduce sales, adversely affect
our operating results and financial condition, delay the launch of new medicines and vaccines, and
negatively impact our image
Many of our medicines and vaccines are manufactured using technically complex processes with production constraints,
including the need for specialized facilities, trained and certified employees, and highly specific raw materials. We must ensure
that all manufacturing processes comply with (i) current Good Manufacturing Practices (cGMP), (ii) other applicable regulations
issued by governmental health authorities around the world, and (iii) our own quality standards. Third parties supply us with a
portion of our raw materials, active ingredients, finished drug products, medical devices and quality control testing, which
exposes us to the risk of a supply shortage or interruption especially if these suppliers are unable to manufacture our medicines
and vaccines on time or in line with quality standards or if they experience financial difficulties.
Epidemics and other public health crises expose us to risks of a slowdown or temporary suspension in the production of our active
pharmaceutical ingredients, raw materials, and some of our medicines and vaccines, and may have a material and adverse effect
on our manufacturing operations if they impact our principal production sites. Any of these factors could adversely affect our
business, operating results, or financial condition (see “Item 4. Information on the Company — B.7. Production and raw materials”
for a description of these outsourcing arrangements and “A failure in our crisis and business continuity management processes in
case of unpredictable events could have negative consequences for our business, operations and reputation” below).
Our business may require the transformation and adaptation of our plants to ensure the continuity of production of our
medicines and vaccines in sufficient quantities to satisfy demand. This may be necessary to meet the need to produce new
medicines and vaccines, or to ensure the scaling up production of products under development once approved. This need may
also result from new regulatory requirements. Furthermore, our biological medicines and vaccines are subject to the risk of
manufacturing stoppages or the risk of loss of inventory because of the difficulties inherent in the processing of biological
materials and the potential difficulties in accessing adequate amounts of raw materials meeting required standards. In addition,
specific storage and distribution conditions are required for many biological medicines and vaccines (for example, cold storage is
necessary for certain vaccines, insulins, and some clotting factor medicines). These production difficulties may also be
encountered during testing, which is a mandatory requirement prior to drug products being released.
The complexity of our production processes, as well as standards required subject us to certain risks, particularly because the
research and remediation of any identified or suspected problems may cause production delays, substantial expense, product
recalls, loss of sales or inventories, and delays in launches. This could adversely affect our operating results and financial
condition, and cause reputational damage and the risk of product liability (see “— Product liability claims could adversely affect
our business, results of operations and financial condition” above). Our medicines and vaccines, and their compositions (including
the identification of potential unexpected or unspecified impurities), are increasingly scrutinized by health and safety agencies. In
addition, some of our production sites, and some of our suppliers’ and/or contractors’ sites, are in areas exposed to natural
disasters such as floods, earthquakes, and hurricanes (see “— Climate change or legal, regulatory or market measures to address
climate change may negatively affect our business and results of operations” below). Such disasters could be exacerbated by
climate change. In the event of a major disaster, we could experience severe destruction or interruption of our operations and
production capacity at these sites.
When manufacturing disruptions occur, we may not have alternate manufacturing capacity, particularly for certain biologics. In
the event of manufacturing disruptions, our ability to use backup facilities or set up new facilities is more limited because
biologics are more complex to manufacture and generally require dedicated facilities. Even though we aim to have backup
sources of supply whenever possible, including by manufacturing backup supplies of our principal active ingredients at additional
facilities when practicable, we cannot be certain they will be sufficient if our principal sources become unavailable. Switching
sources and manufacturing facilities requires significant time and prior approval by health authorities. Additionally, we may be
subject to requirements to locate manufacturing facilities in the region where the manufactured medicines and vaccines are sold,
as a result of local country governmental initiatives or of obligations intended to ensure local supply chain capacity; that may
introduce additional complexity to our global supply chain due to the significant time and regulatory approvals required for such
local facilities to become operational, the significant investment required, and the need to reorganize supply chains that might
otherwise source supplies from other (non-local) regions in order to maximize potential efficiency and benefits.
Supply shortages generate even greater negative reactions when they occur with respect to life saving medicines with limited or
no viable therapeutic alternatives. Shortages of specific medicines and vaccines can have a negative impact on the confidence of
patients, customers, professional healthcare providers, health authorities and the image of Sanofi and may lead to lower sales.
A substantial share of the sales and income of Sanofi depends on the performance of certain key
medicines and vaccines
Our current strategy, as presented in December 2019 and updated in October 2023, focuses on key growth drivers in the key
disease areas of immunology, rare diseases, neurology, selectively in oncology, and vaccines. Nevertheless, market expansion,
acquisitions, investments and new launches of medicines and vaccines may not deliver the anticipated benefits. We may also
encounter delays or failures in our launch strategy (in terms of timing, pricing, market access, marketing efforts, and dedicated
sales forces), such that our medicines and vaccines may not deliver the expected benefits. The competitive environment for a
given medicine or vaccine may also have changed by the time of the actual launch, necessitating a modification of our initial
forecasts. The need to prioritize the allocation of resources may also cause delays in or hamper the launch or expansion of certain
medicines or vaccines.
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ITEM 3. Key Information |
Also, we currently generate a substantial share of our sales from certain key medicines and vaccines (see “Item 5. Operating and
Financial Review and Prospects — A.2.1. Net sales — 3/Net Sales – Biopharma segment”). For example, Dupixent generated net
sales of €15,714 million in 2025, representing 36.0% of our net sales for the year, and is Sanofi’s biggest product in terms of sales.
Among our key medicines, Lantus, Lovenox, Plavix, Jevtana and Aubagio face generic or biosimilar competition on the market. In
2025, Lantus was one of Sanofi’s leading medicines in terms of sales with net sales of €1,733 million. With respect to influenza,
which represented together with Covid 29.2% of vaccines net sales in 2025, we may face potential challenges. The influenza
market is expected to have several new competitive entrants, including both standalone flu mRNA vaccines and COVID-flu
combinations, which could be on the market ahead of us. Additionally, the influenza market globally is subject to intense pricing
pressure, as well as a decrease in vaccination coverage, and anti-vaccine policies could further erode confidence in vaccines and
change the regulatory and/or access framework, especially in the US. The combination of such factors could result in a lowering
of revenue from sales of influenza vaccines. Beyfortus, which represented 22.4% of our vaccines net sales in 2025, is facing
competition from another monoclonal antibody, which could negatively impact our revenue in this area.
More generally, expiration of effective intellectual property protections for our medicines typically results in the market entry of
one or more lower-priced generic or biosimilar competitors, often leading to a rapid and significant decline in revenues from
those medicines (for information regarding ongoing patent litigation see Note D.22.b. to the consolidated financial statements
included at Item 18. of this annual report).
Furthermore, in general, if one or more of our key medicines or vaccines were to encounter problems (such as material product
liability litigation, unexpected side effects, product recalls, non-approval by the health authorities of a new indication for a
marketed medicine, adverse coverage or utilization guidelines, pricing pressure, and manufacturing or supply issues), the adverse
impact on our business, results of operations and financial condition could be significant.
We rely on third parties for the discovery, manufacture, marketing, and distribution of some
of our medicines and vaccines
Our industry is both highly collaborative and competitive, whether in the discovery and development of new medicines and
vaccines , in-licensing, marketing and distribution, or manufacturing activities. We expect that we will continue to rely on third
parties for key aspects of our business and we need to ensure our attractiveness as a potential partner.
We conduct several significant research and development programs and market some of our medicines or vaccines in
collaboration with other biotechnology and pharmaceutical companies. For example, we currently have a global strategic
collaboration with Regeneron on monoclonal antibodies for the development and commercialization of Dupixent, Kevzara and
SAR440340 (REGN3500- itepekimab) (see “Item 5. Operating and Financial Review and Prospects — A.1.7.1 Alliance
Arrangements with Regeneron Pharmaceuticals Inc.”). We rely upon Regeneron to successfully carry out their responsibilities
regarding the manufacture and supply of these collaboration antibodies (see “Item 4. Information on the Company — B. Business
Overview”). In May 2024, we announced a co-exclusive licensing agreement to develop novel flu-COVID-19 combination
vaccines with Novavax (see “—Research, clinical development and regulatory approval processes present significant risks to our
pipeline success and portfolio renewal”). We may also rely on partners to design and manufacture medical devices for the
administration of our medicines or vaccines. Finally, we may rely on partners for the development and commercialization of in-
vitro diagnostic tests used in clinical studies, and in-vitro diagnostic tests specified in the labeling of our medicines as necessary
or useful for the management of patients taking our medicines. As regards some medicines and vaccines launched or under
development for which we have a collaboration agreement with partners, the terms of the applicable alliance agreement may
require us to share profits and losses arising from commercialization of such medicines and vaccines with our partners. This
differs from the treatment of revenue and costs generated by other medicines and vaccines for which we have no alliance
agreement, and such profit sharing may deliver a lower contribution to our financial results.
We could also be subject to the risk that we may not properly manage the decision-making process with our partners. Decisions
may be controlled by or subject to the approval of our collaboration partners, who may have views that differ from ours. We are
also subject to the risk that our partners may not perform effectively, which could have a detrimental effect when our
collaboration partners are responsible for the performance of certain key tasks or functions, for example related to clinical trials
manufacturing or distribution. This risk is further increased by the growing number of distribution centers divested by Sanofi as
part of its global strategy and by the resulting growing externalization of distribution tasks and functions.
Any failures in the development process or differing priorities may adversely affect our business, including the activities
conducted through our collaboration arrangements. We also cannot guarantee that third-party manufacturers will be able to
meet our near-term or long-term manufacturing requirements, for internal reasons (e.g. in case of financial difficulties), reasons
directly related to their contractual relationship with Sanofi, or external reasons (e.g. in the event of a health crisis). For instance,
following the completion of the spin-off of EUROAPI in May 2022, EUROAPI became a third-party manufacturer and continues to
manufacture a certain number of active pharmaceutical ingredients for Sanofi. We are also subject to the risk that contract
research organizations or other vendors (for instance regarding digital activities) retained by us, or our collaboration partners,
may not perform effectively.
Any conflicts, difficulties or litigation with our partners during these agreements or at the time of their renewal or renegotiation,
or any disruption in the relationships with our partners, may affect the development, manufacturing, launch and/or marketing of
certain of our existing or potential new medicines or vaccines and may cause a decline in our revenues or otherwise negatively
affect our results of operations.
(1)The information in this section supplements the disclosures required under IFRS 7 as presented in Notes B.8.7., D.10. and D.34. to our consolidated
financial statements, provided at Item 18. of this annual report.
(2)The information in this section supplements the disclosures required under IFRS 7 as presented in Note B.8.7. to our consolidated financial statements,
provided at Item 18. of this annual report.
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ITEM 3. Key Information |
We are subject to the risk of non-payment by our customers(1)
Our customers, which consist principally of wholesalers, distributors, pharmacies, hospitals, clinics, and government agencies,
present risks related to delayed payments or even non-payment. This risk is accentuated by concentrations among distributors
and retailers, as well as by ongoing uncertainties in global credit markets and economic conditions, in particular in emerging
markets. As a result, we may be affected by fluctuations in the buying patterns of such customers. The United States presents
specific customer credit risk issues because of the concentrated pharmaceutical distribution system: in 2025 our three main
customers represented respectively 18%, 12% and 6% of our consolidated net sales, respectively. We are also exposed to large
wholesalers in other regions, particularly in Europe. An inability of one or more of these wholesalers to honor their debts to us
could adversely affect our financial condition (see Note D.34. to our consolidated financial statements included at Item 18).
In certain countries, some of our customers are public or subsidized health systems. The economic and credit conditions in these
countries could further extend the average collection period for accounts receivable, putting additional strain on our working
capital.
Global economic conditions and an unfavorable financial environment could have negative
consequences for our business(2)
Over the past several years, growth of the global pharmaceutical market has increasingly been tied to global economic trends. In
this context, a substantial and lasting slowdown or instability of the global economy, major national economies or emerging
markets could negatively affect the global pharmaceutical market's growth and, as a result, adversely affect our business.
Unpredictable geopolitical conditions that currently exist in various parts of the world could have a material negative impact on
our business, in particular the armed conflict between Russia and Ukraine, and ongoing or potential further conflicts in the Middle
East and rising geopolitical tensions between the US and China, two of our key markets. The consequences of these conflicts
remain uncertain, and will depend on developments outside Sanofi’s control, including but not limited to the duration and severity
of the conflicts, and the consequences of the ongoing and additional financial and economic sanctions imposed by governments
in response. Trade, economic, technological and military conflicts could disrupt supply chains, raise raw material costs, and affect
clinical and manufacturing operations and business strategy. Other related issues have arisen or are arising such as regional
instability; geopolitical uncertainties; adverse effects on fuel and energy costs, supply chains, macroeconomic conditions,
inflation, and currency exchange rates in various regions of the world; and exposure of third parties to gas shortages. Collectively,
such unstable conditions could, among other things, disturb the international flow of goods and increase the costs and difficulties
associated with international transactions.
Unfavorable economic conditions have reduced the sources of funding for national social security systems, leading to austerity
measures including heightened pressure on drug prices, increased substitution of generic drugs, and the exclusion of certain
medicines from formularies among others (see “— The pricing and reimbursement of our medicines and vaccines are negatively
affected by increasing cost containment pressures and major policy shifts ” above).
The challenging economic environment could also negatively impact our net sales. In regions with high unemployment, rising
inflation, or limited third-party payer systems, patients may turn to more affordable generic alternatives, delay treatments, or
reduce observance to cut costs. In the United States there has been a significant increase in the number of beneficiaries in the
Medicaid program, under which sales of pharmaceuticals are subject to substantial rebates and, in many US states, to formulary
restrictions limiting access to brand-name drugs, including ours. Additionally, rising healthcare costs have prompted some
employers to transfer a greater share of these costs to their employees, which further decreases demand for brand-name
pharmaceuticals and intensifies downward pressure on prices.
Should global economic conditions worsen, or in the event of default or failure of major players including wholesalers or public
sector buyers financed by insolvent states, Sanofi's financial situation, profitability, operational results, and product distribution
channels could be adversely affected. See also “— We are subject to the risk of non-payment by our customers” above.
A failure in our crisis and business continuity management processes in case of unpredictable events
could have negative consequences for our business, operations, and reputation
We have increased crisis preparedness and response in recent years due to crises such as the COVID-19 pandemic, the ongoing
war in Ukraine and conflicts in the Middle East. Nevertheless, unpredictable and extraordinary internal or external events, or a
combination of escalating events that may occur as a result of a large scale cyber-attack (see also “— Breaches of data security,
disruptions of information technology systems and cyber threats could result in financial, legal, competitive, operational,
business, or reputational harm” above), a pandemic or natural disasters, could result in the failure of critical processes within
Sanofi or a third party on whom we rely. Moreover, lack of resources and/or low maturity level in crisis management of our service
providers faced with an increasing number of major international crises may hamper our ability to implement our business
continuity plans. Such failure or limited implementation of our business continuity plans may adversely impact our business,
operations, and reputation.
The occurrence of such unforeseen events may also heighten other risks such as a disruption or temporary suspension in
production of active pharmaceutical ingredients, raw materials and some of other products and/or lead to manufacturing delays
or disruptions and supply chain interruptions (including to the extent those measures apply to our third-party suppliers) and may
have an adverse effect on our business (see “— The manufacture of our medicines and vaccines is technically complex, and
supply interruptions, product recalls or inventory losses caused by unforeseen events may reduce sales, adversely affect
our operating results and financial condition, delay the launch of new medicines and vaccines, and negatively impact our image”
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ITEM 3. Key Information |
above). Also, a sudden increase in demand for selected medicines and vaccines in the event of a crisis can result in short-term
unavailability or shortages of raw materials.
Climate change or legal, regulatory or market measures to address climate change may negatively affect
our business and results of operations
Climate change resulting from increased concentrations of carbon dioxide and other greenhouse gases in the atmosphere could
present both physical and transition risks to our operations.
Physical risks include adverse impacts on global temperatures, weather patterns and the frequency and severity of extreme
weather and natural disasters. Natural disasters and extreme weather conditions, such as a hurricane, tornado, wildfire, or
flooding, may pose physical risks to our facilities and disrupt the operation of our supply chain. The impacts of the changing
climate on water resources may result in water scarcity, limiting our ability to access sufficient high-quality water in certain
locations, which may increase operational costs.
Concern over climate change may also result in new or additional legal or regulatory requirements, designed to reduce
greenhouse gas emissions and/or mitigate the effects of climate change on the environment. If such laws or regulations were to
be more stringent than current legal or regulatory obligations (e.g. increased carbon taxation risk), we may experience disruption
in, or an increase in the costs associated with sourcing, manufacturing, and distribution of our medicines and vaccines, which may
adversely affect our business, results of operations or financial condition.
The use of social media platforms and communication technologies present risks and challenges
for our business and reputation
The use of social media, technologies and digital tools to communicate about our medicines and vaccines and about diseases or
to provide health services requires specific attention, monitoring programs, and moderation of comments. Political and market
pressures may be generated by social media because of rapid news cycles. This may result in commercial harm, overly restrictive
regulatory actions, and erratic share price performance. In addition, unauthorized communications, such as press releases or
posts on social media purported to be issued by Sanofi, may contain information that is false or otherwise damaging and could
have an adverse impact on our image and reputation and on our stock price. Negative or inaccurate posts or comments about
Sanofi, our business, directors, or officers on any social networking website could seriously damage our reputation. In addition,
our employees and partners may use social media and mobile technologies inappropriately, which may give rise to liability for
Sanofi, or which could lead to breaches of data security, loss of trade secrets or other intellectual property or public disclosure of
sensitive information. Such uses of social media and mobile technologies could have an adverse effect on our reputation,
business, financial condition, and results of operations.
Data sovereignty regulations could significantly impact Sanofi's global operations and strategic
initiatives
Data sovereignty regulations increasingly restrict cross-border data flows critical to our activities. Accelerating geopolitical
tensions have transformed data sovereignty from focusing primarily on privacy concerns to focusing on national security
imperatives, as evidenced by the US Data Security Program (DSP). Our early-stage pipeline development, M&A activities, digital
transformation initiatives, AI scaling ambitions, and end-to-end supply chain all depend on cross-border data flows now subject
to increasing restrictions. Such rules and regulations could have a material adverse impact on our business, results of operations
or financial condition, including due to our diverse portfolio, our extensive research activities, the fragmented digital landscape
with which we are forced to comply, our extensive third-party relationships, and our global supply chain. These risks expose us to
potential operational disruptions, increased compliance costs, regulatory penalties, and compromised innovation capabilities.
Risks relating to Sanofi’s structure and strategy
We may fail to successfully identify external business opportunities or realize the anticipated benefits
from our strategic investments or divestments
We pursue a strategy of selective acquisitions, in-licensing, and collaborations to reinforce our pipeline and portfolio. We are also
proceeding with selective divestments to focus on key business areas. The implementation of this strategy depends on our ability
to identify transaction opportunities, mobilize the appropriate resources to enter into agreements in a timely manner, and
execute these transactions on acceptable economic terms, especially in an increased competitive landscape where multiple large
pharmaceutical companies will face patent cliffs by 2030. Moreover, entering into in-licensing or collaboration agreements
generally requires the payment of significant “milestones” well before the relevant medicines and vaccines reach the market,
without any assurance that such investments will ultimately become profitable in the long term (see Note C. to our consolidated
financial statements included at Item 18 of this annual report and “— We rely on third parties for the discovery, manufacture,
marketing, and distribution of some of our medicines and vaccines” above). Once a strategic transaction is agreed upon with a
third party, we may not be able to complete the transaction in a timely manner or at all or achieve the anticipated benefits.
For example, following the divestment of Opella that was completed in April 2025, our remaining business is smaller and less
diversified than previously. Post-divestment we have greater relative exposure to the global pharmaceuticals and vaccines
markets and the associated risks and will no longer benefit from exposure to the Consumer Healthcare market we had prior to
divestment of the Opella business. Also, our remaining holding in Opella may fall in value if Opella's strategy does not deliver the
expected benefits.
For newly acquired activities or businesses, our growth objectives could be delayed or ultimately not realized, and expected
synergies could be adversely impacted if, for example we are unable to integrate those activities or businesses quickly or
efficiently, key employees leave, or we have higher than anticipated integration costs.
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ITEM 3. Key Information |
The Translate Bio acquisition, completed in 2021, may not generate the expected results in terms of developing new mRNA-
based vaccines to meet our existing or future needs. In 2025, we acquired Blueprint Medicines Corporation; however, we may
face risks of delays in development timelines as there is still uncertainty in the progress of early-stage pipeline immunology, and
hence we may not realize the expected benefits of the acquisition.
We may also miscalculate the risks associated with business development transactions at the time they are made or may lack the
resources or ability to access all the relevant information to evaluate such risks properly, including regarding the potential of
research and development pipelines, manufacturing issues, tax or accounting issues, compliance issues, or the outcome of
ongoing legal and other proceedings. It may also take a considerable amount of time and be difficult to implement a risk analysis
and risk mitigation plan after the acquisition of an activity or business is completed due to lack of historical data. Acquired
businesses may not always be in full compliance with legal, regulatory or Sanofi standards, including, for example, current Good
Manufacturing Practices (cGMP), which can be costly and time consuming to remedy. As a result, risk management and coverage
of such risks, particularly through insurance policies, may prove to be insufficient or ill-adapted.
With respect to divestments, their financial benefit could be impacted if we face significant financial claims or significant post-
closing price adjustments. Furthermore, the value of the assets to be divested may deteriorate while we are in the process of
executing our divestment strategy, with the risk that we do not realize the anticipated benefits.
Because of the active competition among pharmaceutical groups for business development opportunities, there can be no
assurance of our success in completing these transactions when such opportunities are identified.
The globalization of our business exposes us to increased risks in specific areas
As part of the presentation of our strategy in December 2019 and updated in October 2023, we identified our strong presence in
China among our core drivers, with revenue amounting to 6.0% of our net sales in 2025.
The difficulties in operating in emerging markets, a significant decline in the anticipated growth rate or an unfavorable movement
in the exchange rates of currencies against the euro could impair our ability to take advantage of growth opportunities and could
adversely affect our business, results of operations or financial condition. For instance, if a long-lasting epidemic and prolonged
or repeated restrictive measures to control the outbreak were to result in an economic slowdown in any of our targeted markets,
it would reduce our sales due to lower healthcare spending on other diseases and fewer promotional activities, and could
significantly impact our business operations. Furthermore, it is not possible to predict if or how such a health crisis would impact
any affected jurisdiction, or to what extent (see also “— Global economic conditions and an unfavorable financial environment
could have negative consequences for our business” above).
Emerging markets also expose us to more volatile economic conditions; legal, regulatory and political instability, both globally and
locally (including a backlash in certain areas against free trade); competition from multinational or locally based companies that
are already well established in these markets; the inability to adequately respond to the unique characteristics of emerging
markets (particularly with respect to their underdeveloped judicial systems and regulatory frameworks); difficulties in recruiting
qualified personnel or maintaining the necessary internal control systems; difficulties that may adversely affect our ability to
supply our medicines and vaccines; potential exchange controls; weaker intellectual property protection; higher crime levels
(particularly with respect to counterfeit products); and compliance issues including corruption and fraud (see particularly
“— Claims and investigations relating to ethics and business integrity, competition law, marketing practices, pricing, human rights
of workers and other legal matters could adversely affect our business, results of operations and financial condition” above).
Given the increasing globalization of our business, if relations between the United States, European Union countries and other
governments deteriorate, our business and investments in such markets may also be adversely affected. For example, the
proposed federal BIOSECURE Act in the United States would prohibit federal agencies from entering into certain contracts with
or incurring expenditures related to companies that have specified commercial connections with “biotechnology companies of
concern” (the identification criteria for which have not been determined, and the list of which has not been defined and could be
very extensive, including companies in China); if enacted, that proposed Act or similar provisions could restrict our ability to
contract or collaborate with such biotechnology companies. This, in turn, could materially and adversely affect our or our
collaboration partners’ ability to manufacture or supply marketed and potential new medicines and vaccines, or to advance our or
our collaboration partners’ preclinical research, which could materially and adversely affect our business and prospects.
We may fail to develop or take advantage of digitalization and prioritizing data as an organizational
asset
We have undertaken several digital initiatives, such as the implementation of AI across our business. For example, in research and
development, we have built multiple AI programs to reduce research times through improved predictive modelling. We are also
seeking to automate time-consuming activities, enabling research and development teams to scale and accelerate research
processes and improve potential target identification in therapeutic areas such as immunology, oncology and neurology. In
manufacturing and supply, we have developed an in-house AI-enabled yield optimization solution that delivers higher yield levels
and optimizes usage of raw materials.
Our success in these efforts will depend on many factors including data availability; entering into successful partnerships and
alliances with technology companies (such as the AI collaboration with Formation Bio and OpenAI announced in May 2024, aimed
at building AI-powered software to accelerate drug development ); a profound transformation of our organization; a cultural
change among our employees, and the development of relevant skills; our ability to adopt AI agents; attracting and retaining
employees with appropriate skills and mindsets in a tight labor market; and successfully innovating across a variety of technology
fields, while seeking to comply with evolving external regulations. The success of digital initiatives will also depend on our ability
to shift our culture to a data-driven culture and to transform the architecture of our business process designs to integrate AI. This
calls for management of data as an asset and the definition of a robust life-cycle management process for data that is applied
consistently across Sanofi. In recent years, we have accelerated our digital transformation, including in the ways we engage and
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ITEM 3. Key Information |
interact with our stakeholders. However, there is no guarantee that our efforts towards digital transformation will succeed. More
generally, we may fail to capture the benefits of AI, digitalization and valuing data as an enterprise asset at an appropriate cost
and/or in a timely manner, and/or enter into appropriate partnerships. Competitors, including new entrants such as tech
companies, may outpace us in this fast-moving area. If we fail to adequately integrate digital capabilities into our organization
and business model, we could lose patients and market share. This could have an adverse impact on our business, prospects, and
results of operations. We may also become dependent on certain technologies developed by third-party AI service providers,
leading to the risk of our own failure to develop internal technology and risks of loss of the use of the related AI tools in the event
of interruption or breaches of the relationship with such third-party suppliers. Because AI is an emerging technology, it is possible
that our use of AI technologies may not have the intended effects or benefits, such as increasing efficiency. In addition, the use
of AI technologies presents certain risks, including the use of personal data as described above (see “— Failure to comply with
data ethics and privacy regulations could adversely affect our business and reputation" above). In addition, AI tools and
algorithms may be flawed or trained on content without the necessary intellectual property rights or other legal rights or
permissions; data sets may not be appropriate for the intended use, of poor quality, or contain biased information; and
inappropriate or controversial data practices could be applied by third parties, data scientists, engineers, and/or end-users. If
such risks materialize or the outputs that AI produces or assists in producing are deficient or inaccurate, we could be subjected to
potential legal liability and reputational harm. Furthermore, use of AI may lead to the release of confidential information which
may impact our ability to realize the benefits of our data, including intellectual property.
Misuse of such technologies could negatively affect our reputation, disrupt our operations, or otherwise have a material adverse
impact on our financial results and could also subject us to legal and reputational risks.
We may fail to accelerate our operational efficiency and execute our transformation program
As part of the presentation of the next chapter of our Play to Win strategy in October 2023, we announced our intent to improve
our operational efficiencies to fund growth. To deploy our strategy, we must also disrupt our normal course of business and
transform our operations. Nevertheless, we may not succeed in federating employees behind the transformation program, which
may hamper our ability to execute such organizational changes. Besides, there is no guarantee that we will be able to fully deliver
these operating efficiencies.
Unsuccessful management of sustainability (environmental, social and governance) matters
could adversely affect our reputation and we may experience difficulties meeting the expectations
of our stakeholders
Companies are increasingly expected to behave in a responsible manner on a variety of sustainability matters, by governmental
and regulatory authorities, counterparties such as vendors and suppliers, customers, investors, the public at large and others. This
context, driven in part by a rapidly changing regulatory framework in Europe, is raising new challenges and influencing strategic
decisions that companies must take if they wish to optimize their positive impact and mitigate their negative impact on
sustainability matters. These evolving regulatory requirements are also likely to result in increased costs and complexities of
compliance to collect, measure and report on the relevant ESG-related information, and may expose us to additional regulatory,
litigation and reputational risk. Given recent political and geopolitical pressures, there is also the possibility that some or part of
these rules or regulations are rolled back or amended, in which case we would face additional compliance costs and, depending
on such changes, we may face other adverse effects described below.
We have adopted a sustainability strategy that aims to tackle the impact of environmental changes on health and healthcare by
improving sustainable and equitable access to our medicines and vaccines, by reducing the environmental impact of our own
operations, and where possible by contributing through collective efforts to reduce healthcare systems' environmental footprints
and improve their resilience.
However, despite our ambitions we may be unable to meet our sustainability or other strategic objectives efficiently, on time, or
at all.
Furthermore, statements about our ESG-related initiatives and goals, and progress against those goals, may be based on
standards for measuring progress that are still developing, internal controls and processes that continue to evolve and
assumptions that are subject to change in the future.
We may also be unable to meet the ever more demanding criteria used by rating agencies in their sustainability assessments
process, leading to a downgrading in our ratings. Such ratings are increasingly used by major institutional investors to inform their
investment decisions.
Depending on sustainability assessments, our ability to fulfill our sustainability strategy, and on the rapidly changing views on
acceptable levels of action across a range of sustainability topics from investors, we may be unable to meet society’s or investors’
expectations or the targets or goals contained in our sustainability strategy, in which case our reputation may be harmed; we may
face increased compliance or other costs; and interest in subscribing to securities issued by us, and our ability to participate in
the debt and equity markets, may decrease. In addition, we could be criticized for the scope or nature of such initiatives or goals,
or for any revisions to these goals.
In addition, in recent years “anti-ESG” sentiment has gained momentum across the US, with several states and Congress having
proposed or enacted “anti-ESG” policies, legislation, or initiatives or issued related legal opinions, and the US President having
issued an executive order opposing diversity equity and inclusion (DEI) initiatives in the private sector. The anti-ESG and anti-DEI-
related policies, legislation, initiatives, litigation, scrutiny and other actions could result in additional compliance obligations,
Sanofi becoming the subject of investigations and enforcement actions, or otherwise suffering reputational harm.
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ITEM 3. Key Information |
Our success depends in part on our senior management team and other key employees and our ability to
attract, integrate and retain key personnel and qualified individuals in the face of intense competition
Our success depends on the expertise of our senior management team and other key employees. In 2025, there
were 2,282 “Senior Leaders” within Sanofi. In addition, we rely heavily on recruiting and retaining talented people to help us meet
our strategic objectives. We face intense competition for qualified individuals for senior management positions, or in specific
geographic regions or in specialized fields such as clinical development, biosciences and devices, or digital and AI. Our ability to
hire qualified personnel also depends in part on our ability to reward performance, incentivize our employees and pay
competitive compensation. The inability to attract, integrate and/or retain highly skilled personnel, in particular those in
leadership positions, may weaken our succession plans, may materially adversely affect the implementation of our strategy and
our ability to meet our strategic objectives, and could ultimately adversely impact our business or results of operations.
Environmental and safety risks of our industrial activities
Risks from manufacturing activities and the handling of hazardous materials could adversely affect
our results of operations and reputation
Manufacturing activities, such as the chemical manufacturing of the active ingredients in our medicines and vaccines and the
related storage and transportation of raw materials, products and waste, expose us to risks of industrial accidents that may lead
to discharges or releases of hazardous substances or other events that can cause personal injury, property damage and
environmental contamination, and may result in additional operational constraints, including the shutdown of affected facilities
and/or the imposition of civil, administrative, criminal penalties and/or civil damages, and affect Sanofi’s reputation.
The occurrence of an industrial accident may significantly reduce the productivity and profitability of a particular manufacturing
facility and adversely affect our operating results and reputation. Although we maintain property damage, business interruption
and casualty insurance that we believe is in accordance with customary industry practices, this insurance may not be adequate to
fully cover all potential hazards incidental to our business.
Management of the historical contamination related to our past industrial activities could adversely
impact our results of operations and reputation
The environmental laws of various jurisdictions impose actual and potential obligations on our Company to manage and/or
remediate contaminated sites. These obligations may relate to sites (i) that we currently own or operate; (ii) that we formerly
owned or operated; or (iii) where waste from our operations was disposed.
These environmental remediation obligations could reduce our operating results. Sanofi accrues provisions for remediation when
our management believes the need is probable and that it is reasonably possible to estimate the cost (see Note D.22 to our
consolidated financial statements included at Item 18 of this annual report). Our provisions for these obligations may be
insufficient if the assumptions underlying these provisions prove incorrect or if we are held responsible for additional, currently
undiscovered contamination. These judgments and estimates may later prove inaccurate, and any shortfalls could have an
adverse effect on our results of operations and financial condition. For more detailed information on environmental policies and
issues, see “Item 4. Information on the Company — B.9. Health, Safety and Environment" and Notes "B.12. Provisions for risks" and
"D.19.3. Other provisions" to our consolidated financial statements included at Item 18 of this annual report.
We are or may become involved in claims, lawsuits and administrative proceedings relating to environmental matters.
Some current and former Sanofi subsidiaries have been named as “potentially responsible parties” or the equivalent under
the US Comprehensive Environmental Response, Compensation and Liability Act of 1980, as amended (CERCLA, also known
as “Superfund”), and similar statutes or obligations in France, Germany, Italy, Brazil and elsewhere. As a matter of statutory or
contractual obligations, we and/or our subsidiaries may retain responsibility for environmental liabilities at some of the sites of our
predecessor companies, or of subsidiaries that we demerged, divested, or may divest. We have disputes outstanding regarding
certain sites no longer owned or operated by Sanofi. An adverse outcome in such disputes might have an adverse effect on our
operating results. See Note D.22.d to our consolidated financial statements included at Item 18 of this annual report and
“Item 8. Financial Information — A. Information on Legal or Arbitration Proceedings”.
Environmental regulations are evolving. For example, in Europe, new or evolving regulatory regimes include the Registration,
Evaluation, Authorization and Restriction of Chemicals Regulation (which may include, in the future, a restriction on per- and
polyfluoroalkyl substances (PFAS) based on a recent draft released by the European Chemicals Agency (ECHA)); the
Classification and Labelling regulations applicable to hazardous chemicals; directives related to the control of major-accident
hazards (the “Seveso” directives); the Industrial Emission regulations; the Waste Framework Directive; the Emission Trading
Scheme Directive; the Water Framework Directive; the Directive on Taxation of Energy Products and Electricity; and the recently
adopted Urban Wastewater Treatment Directive, as well as other regulations aimed at protecting public health or preventing
climate change. Stricter environmental, safety and health laws and enforcement policies could result in substantial costs and
liabilities to Sanofi and could subject our handling, manufacture, use, reuse or disposal of substances or pollutants, site restoration
and compliance to more rigorous scrutiny than is currently the case. Consequently, compliance with these laws could result in
capital expenditures as well as other costs and liabilities, thereby adversely affecting our business, results of operations or
financial condition.
(3)The information in this section supplements the disclosures required under IFRS 7 as presented in Note B.8.7. to our consolidated financial statements,
provided at Item 18. of this annual report.
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ITEM 3. Key Information |
Risks related to financial markets(3)
Fluctuations in currency exchange rates could adversely affect our results of operations
and financial condition
Because we sell our medicines and vaccines in numerous countries, our results of operations and financial condition could be
adversely affected by fluctuations in currency exchange rates. We are particularly sensitive to movements in exchange rates
between the euro and the US dollar, the Japanese yen, the Chinese yuan, and currencies in emerging markets. In 2025, 50.8% of
our net sales were generated in the United States, 21.0% in Europe, and 28.2% in the Rest of the World region (see the definition
in “Item 5. Operating and Financial Review and Prospects — A. Operating results”), including countries that are, or may in future
become, subject to exchange controls (including 6.0% in China and 3.2% in Japan). While we incur expenses in those currencies,
the impact of currency exchange rates on these expenses does not fully offset the impact of currency exchange rates on our
revenues. As a result, currency exchange rate movements can have a considerable impact on our earnings. When deemed
appropriate and when technically feasible, we enter into transactions to hedge our exposure to foreign exchange risks. These
efforts, when undertaken, may fail to offset the effect of adverse currency exchange rate fluctuations on our results of operations
or financial condition. For more information concerning our exchange rate exposure, see “Item 11. Quantitative and Qualitative
Disclosures about Market Risk.”
Risks relating to an investment in our shares or ADSs
Foreign exchange fluctuations may adversely affect the US dollar value of our ADSs and dividends
(if any) regardless of our operating performance
Holders of American depositary shares (ADSs) face exchange rate risks. Our ADSs trade in US dollars and our shares trade in
euros. The value of the ADSs and our shares could fluctuate substantially as the exchange rates between these currencies
fluctuate. When we pay dividends, they would be denominated in euros. Fluctuations in the exchange rate between the euro and
the US dollar will affect the US dollar amounts received by owners of ADSs upon conversion by the depositary of cash dividends,
if any. Moreover, these fluctuations may affect the US dollar price of the ADSs on the NASDAQ Global Select Market (NASDAQ)
whether or not we pay dividends, in addition to any amounts that a holder would receive upon our liquidation or in the event of a
sale of assets, merger, tender offer or similar transaction denominated in euros or any foreign currency other than US dollars.
Persons holding ADSs rather than shares may have difficulty exercising certain rights as a shareholder
Holders of ADSs may have more difficulty exercising their rights as a shareholder than if they directly held shares. For example, if
we issue new shares and existing shareholders have the right to subscribe for a pro rata portion of the new issuance, the
depositary is allowed, at its own discretion, to sell this right to subscribe for new shares for the benefit of the ADS holders instead
of making that right available to such holders. In that case, ADS holders could be substantially diluted. Holders of ADSs must also
instruct the depositary how to vote their shares. Because of this additional procedural step involving the depositary, the process
for exercising voting rights will take longer for holders of ADSs than for holders of shares. ADSs for which the depositary does not
receive timely voting instructions will not be voted at any meeting. US investors may have difficulty in serving process or
enforcing a judgment against us or our directors or executive officers.
Sales of our shares may cause the market price of our shares or ADSs to decline
Sales of large numbers of our shares, or a perception that such sales may occur, could adversely affect the market price for our
shares and ADSs. L’Oréal, our largest shareholder, is not subject to any contractual restrictions on the sale of the shares it holds in
our Company. L’Oréal does not consider its stake in Sanofi as strategic, and completed an off-market block trade representing
2.3% of our share capital which was bought back by Sanofi in February 2025. See “Item 7. Major Shareholders and Related Party
Transactions" below.
Our largest shareholder owns a significant percentage of the share capital and voting rights of Sanofi
Following our buy-back of a block of shares from L’Oréal in February 2025, and after cancellation of said shares, as of December
31, 2025 L’Oréal held 7.27% of Sanofi’s share capital and 13.10% of Sanofi’s effective voting rights (excluding treasury shares).
Individuals linked to L’Oréal currently serve on Sanofi’s Board of Directors. For as long as L’Oréal retains its interest in our share
capital and voting rights, it will remain in a position to exert influence in the appointment of directors and officers of Sanofi and in
other corporate actions that require shareholder approval.
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ITEM 4. Information on the Company |
Item 4. Information on the Company
Introduction
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling
growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions
of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we
chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our
people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our
time.
In the remainder of this section, medicines and vaccines are referred to either by their international non-proprietary name (INN)
or their brand name, which is generally exclusive to the company that markets it. In most cases, the brand names of our medicines
and vaccines, which may vary from country to country, are protected by specific registrations. In this document, medicines and
vaccines are identified by their brand names used in France and/or in the US.
The segment information presented by Sanofi consists of a single operating segment: Biopharma.
The Biopharma operating segment comprises commercial operations and research, development and production activities
relating to the Specialty Care, General Medicines, and Vaccines franchises plus support and corporate functions, for all
geographical territories. It also includes revenues generated from the manufacture of Consumer Healthcare products invoiced
to Opella Healthcare SAS (Opella), which constitutes a related party with effect from April 30, 2025, the deconsolidation date,
corresponding to the closing of Sanofi's sale of a controlling stake of approximately 50% in Opella to Clayton, Dubilier & Rice
(CD&R) (for more information, see “Item 4. Information on the Company — B. Business overview — B.3 Opella”). Those
revenues, which before the deconsolidation date represented intragroup transactions classified within continuing operations,
are presented within Other revenues in the income statement. The Biopharma operating segment also includes the purchase
price of Biopharma products manufactured by Opella.
The “Other” category comprises primarily, but not exclusively, Consumer Healthcare activities not transferred on the effective
date of loss of control of Opella. These are primarily (i) hospital sales of Opella products in China, the transfer of which will be
finalized no earlier than 2028; (ii) sales made by the dedicated entity Opella Russie, of which Sanofi continues to hold the
capital (Sanofi is continuing to distribute Opella products in Russian territory under a distribution agreement signed in
connection with the separation, the parties reserving the right to discuss the transfer of that entity during the term of the
distribution agreement); and (iii) sales of the Gold Bond product range, which are continuing in the US through the retained
subsidiary Gold Bond LLC (holder of the associated worldwide property rights).
A. History and development of the Company
The current Sanofi company was incorporated under the laws of France in 1994 as a société anonyme, a form of limited liability
company, for a term of 99 years. Since May 2011, we have operated under the commercial name “Sanofi” (formerly known as
Sanofi-Aventis). Our registered office is located at 46, avenue de la Grande Armée – 75017 Paris – France, our main telephone
number is +33 1 53 77 40 00, and our website (which contains information about the company and information filed with and
provided to the SEC) is www.sanofi.com. Our principal US subsidiary’s office is located at 100 Morris Street, Morristown, New
Jersey 07960 telephone: +1 (908) 981 5000.
The SEC maintains a website at http://www.sec.gov that contains reports, proxy and information statements, and other
information regarding issuers that file electronically with the SEC.
Main events over the last three years
On March 13, 2023, Sanofi and Provention Bio, Inc. (Provention), a US-based publicly-traded biopharmaceutical company
developing therapies to prevent and intercept immune-mediated diseases including type 1 diabetes, entered into an agreement
under which Sanofi acquired the outstanding shares of Provention common stock for $25.00 per share in an all-cash
transaction valued at approximately $2.8 billion. On April 27, 2023, Sanofi announced the completion of its acquisition of
Provention. The acquisition added Tzield/Teizeild (teplizumab), a therapy for type 1 diabetes, to our portfolio.
On May 30, 2024, Sanofi announced that it had completed the acquisition of Inhibrx, Inc. (Inhibrx), a publicly-traded,
clinical-stage biopharmaceutical company focused on developing a pipeline of novel biologic therapeutic candidates in
oncology and orphan diseases. The acquisition added efdoralprin (formerly INBRX-101) to Sanofi’s rare disease development
portfolio. Under the terms of the merger agreement, Sanofi agreed to (i) pay Inhibrx stockholders $30 per share of Inhibrx
common stock on closing of the merger (approximately $1.7 billion) and issue one non-transferable contingent value right (CVR)
per share of Inhibrx common stock, entitling its holder to receive a deferred cash payment of $5, contingent upon the
achievement of certain regulatory milestones (approximately $0.3 billion, if those milestones are achieved); (ii) pay off Inhibrx’s
outstanding third-party debt (approximately $0.2 billion); and (iii) contribute capital to a new publicly traded company (New
Inhibrx) (at least $0.2 billion). Since the closing of the merger, Inhibrx has become a wholly owned subsidiary of Sanofi.
Additionally, Sanofi retains a minority stake (approximately 8%) in New Inhibrx.
On October 21, 2024, Sanofi and CD&R entered into exclusive negotiations for the Opella Transaction, as defined under "—
B.3. Opella," which led to the loss of control previously exercised by Sanofi over Opella and triggered Opella's reclassification as a
discontinued operation under IFRS 5 for the 2024 financial year. As a result, Opella’s post-tax profit or loss was presented
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ITEM 4. Information on the Company |
separately within the line item Net income/(loss) from discontinued operations in Sanofi’s consolidated income statement for
2024 and comparative periods. Following these negotiations, Sanofi sold a 50% controlling stake in Opella to CD&R pursuant to a
share purchase agreement and a separation agreement, and on April 30, 2025, the parties closed the Opella Transaction (for
more information on these agreements and the Opella Transaction, see "— B.3. Opella"). As a result of the transaction, Sanofi
recognized a net gain of €2.6 billion, reported within the line item Net income from discontinued operations in the consolidated
income statement. Sanofi received total net cash proceeds of €10.4 billion, presented within the line item Net cash inflow from
the Opella transaction in the statement of cash flows.
On November 29, 2024, Sanofi entered into a definitive agreement with Recordati S.p.A (Recordati) for the sale of Sanofi's global
rights to Enjaymo; for more information, see “Item 5. — A.1.9. Divestments.”
On May 27, 2025, Sanofi announced the completion of its acquisition of DR-0201, a targeted bispecific antibody developed by
Dren Bio, Inc., a privately held clinical-stage biopharmaceutical company; for more information, see “Item 5. — A.1.1. 2025
Overview.”
On July 18, 2025, Sanofi announced the completion of its acquisition of Blueprint Medicines Corporation (Blueprint); for more
information, see “Item 5. — A.1.1. 2025 Overview.”
On August 5, 2025, Sanofi announced the completion of its acquisition of Vigil Neuroscience, Inc. (Vigil); for more information, see
“Item 5. — A.1.1. 2025 Overview.”
On September 24, 2025, Sanofi Ventures announced an additional $625 million multi-year capital commitment from Sanofi; for
more information, see “Item 5. — A.1.1. 2025 Overview.”
On December 4, 2025, Sanofi announced the completion of its acquisition of Vicebio Ltd (Vicebio); for more information, see
“Item 5. — A.1.1. 2025 Overview.”
On December 19, 2025, Sanofi entered into a major strategic agreement with the US government; for more information, see “Item
5. — A.1.1. 2025 Overview.”
On December 24, 2025, Sanofi announced that it had entered into an agreement to acquire Dynavax Technologies Corporation
(Dynavax); for more information, see “Item 5. — A.1.1. 2025 Overview.”
More detailed information about these changes is provided in Note D.1. to our consolidated financial statements, included at
Item 18. of this annual report.
B. Business overview
Sanofi’s activities are organized around the following categories within the Biopharma operating segment : Immunology, Rare
Diseases, Neurology, Oncology, Other Medicines and Vaccines.
B.1. Strategy
The market context for Sanofi
Several fundamental trends continue to point to a positive outlook for the pharmaceutical industry. The global population is
growing and ageing, and unmet medical needs remain high. Health needs have further increased, strengthening the key roles of
innovation in R&D activities and cutting-edge manufacturing. The industry has taken steps to increase R&D productivity, with the
objective of launching a higher number of innovative medicines and vaccines. Patients around the world – including a rising
middle class in emerging markets – are demanding better healthcare, empowered by access to more and more information. It is a
challenging time scientifically and technologically: the promise of artificial intelligence (AI) is generating new insights into how to
diagnose and treat diseases, and Immunology remains a key therapeutic area with high unmet needs. Digital technologies and
advanced data analytics are having a transformative effect across sales and marketing activities, R&D and manufacturing, and
are acting as enablers for new businesses.
At the same time, increased geopolitical uncertainties, inflation, supply shortages, and issues around government budget
tightening are expected to continue to put pressure on healthcare costs, and on the entire healthcare value chain. Although we
believe that pharmaceuticals and vaccines will remain a fundamentally attractive business within that value chain, the bar for
innovation will most likely continue to rise. Payers will continue to put scrutiny on prices and reimbursement criteria, and demand
demonstration of real-life outcomes to confirm the efficacy of medicines and vaccines. This will be coupled with more innovative
pricing and contracting practices, and more transparent pricing policies. In view of growing concerns over increasing healthcare
costs across global markets, the pharmaceutical industry will be increasingly judged by its contribution to improved access for
patients and to the development of innovative, highly cost-effective medicines.
Strategic framework
Further, faster for patients
We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth.
We apply our deep understanding of the immune system to invent medicines and vaccines that positively impact millions of
(1)In partnership with Regeneron.
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ITEM 4. Information on the Company |
patients suffering from dermatological, respiratory, gastroenterological, and other immune-mediated diseases. And we are
pioneering an innovative pipeline that could benefit millions more.
We are on a mission to go further, faster for patients. We seek to take the lead through breakthrough science and by leveraging
our broad set of technology and manufacturing platforms, including mRNA.
Advancing Breakthrough Science
We are working to strengthen our pipeline with a steady stream of potentially transformative therapies that could shift paradigms
in treatment and prevention for people across the world.
We have a powerful toolbox of drug discovery platforms that allow us to break scientific ground in five therapeutic areas:
Immunology and Inflammation, Oncology, Rare diseases, Neurology and Vaccines.
Advancing Sustainability
Our ambition is to tackle the impact of environmental challenges on health and healthcare. We do this by focusing on three
dimensions: improving equitable and sustainable access to healthcare, reducing the environmental impact of our activities, and
helping transform the delivery of care to minimize the environmental footprint of healthcare systems. Further, we work actively to
embed sustainability in everything we do across the business.
This builds on our “Play to Win” strategy, organized around four key priorities: 1) focus on growth; 2) lead with innovation;
3) accelerate efficiency; and 4) reinvent how we work to drive innovation and growth.
1) Focus on growth
•Dupixent (dupilumab)(1) – By leveraging the product’s unique mechanism of action targeting the type 2 inflammation pathway
and its favorable safety profile, we have raised our ambition for peak sales of Dupixent. In 2025, Dupixent received approval in
the US in bullous pemphigoid (BP), as well as US and EU approval in chronic spontaneous urticaria (CSU).
•Launches – in 2025 Sanofi successfully launched Wayrilz in immune thrombocytopenia, Qfitalia in hemophilia A or B with or
without inhibitors, and Nuvaxovid for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe
acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
•Vaccines – Sanofi has been focusing on four core franchises: Influenza and COVID-19; Meningitis, Travel and Endemics; Polio,
Pertussis and Hib (PPH) & Boosters; and RSV.
•Pipeline – We are focusing our investments on projects in immunology and Inflammation, Oncology, Rare diseases, Neurology
and Vaccines.
2) Lead with innovation
We have been able to shift from a priority medicine list to a steady flow of medicines in a refocused, consistent pipeline. Our
pipeline is showing potential opportunities for market-leading products.
To continue fueling our promising pipeline and to enhance our position in our core therapeutic areas, we have:
i.entered into a license agreement with ADEL, Inc. for development and commercialization rights for ADEL-Y01, which has
first-in-class potential for Alzheimer's;
ii.acquired Vicebio, adding an early-stage combination vaccine candidate for RSV and HMPV;
iii.entered into a research collaboration agreement with InduPro, Inc. (InduPro or InduProTherapeutics) to collaborate on
preclinical and IND-enabling research activities, as well as the right of first negotiation for InduPro’s bispecific PD-1 agonist
program, currently in preclinical development for the treatment of autoimmune and inflammatory disorders;
iv.entered into a collaboration agreement with EVOQ Therapeutics, Inc. (EVOQ) establishing a partnership that enhances our
immunology portfolio by integrating EVOQ’s cutting-edge Antigen Specific Immunotherapy (ASI) technology, designed to
restore immune tolerance to self-antigens by selectively re-educating the immune system;
v.acquired Vigil to strengthen our early-stage pipeline in neurology with VG-3927, a novel, oral, small-molecule TREM2 agonist
which will be evaluated in a Phase 2 clinical study in patients with Alzheimer’s disease;
vi.entered into a licensing agreement with VisiRNA Therapeutics, Inc. for the exclusive development and commercialization
rights of plozasiran in the territory of Greater China;
vii.acquired Blueprint, adding a rare immunology disease medicine, Ayvakit/Ayvakyt (avapritinib), approved in the US and EU and
the only approved medicine for advanced and indolent systemic mastocytosis (ASM & ISM);
viii.entered into a licensing agreement with Libertas Bio, Inc. (a subsidiary of Formation Bio) providing access to Gusacitinib, a
dual JAK/SYK inhibitor, with the intention of exploring its potential as a second line treatment in chronic graft-versus-host
disease (cGVHD) and potentially later in newly diagnosed cGvHD as a steroid free option;
ix.acquired DR-0201, a targeted bispecific myeloid cell engager, from Dren Bio, Inc., to broaden our immunology pipeline and;
x.entered into an agreement to acquire Dynavax Technologies Corporation (Dynavax), a publicly traded vaccines company
with a marketed adult hepatitis B vaccine (HEPLISAV-B) and a differentiated shingles vaccine candidate.
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ITEM 4. Information on the Company |
3) Accelerate efficiency
We continue to improve our cost structure, launching efficiency initiatives across our Biopharma business to free operational
resources to support R&D investment and unlock value-creation opportunities. This includes prioritizing our investments in R&D
and modernizing our approach to commercial delivery.
To transform the practice of medicine, we are developing and deploying AI-powered solutions across all business units at all
levels of Sanofi, not only to increase automation and efficiency, but also to fundamentally change the way we work and think. We
are investing in computational tools and AI to develop a comprehensive digital healthcare platform for employees, patients and
providers. AI and data science are already supporting our teams in areas such as accelerating drug discovery, improving clinical
trial design, and streamlining the manufacture and supply of drugs and vaccines. We are driving a company-wide culture shift
that embeds digital DNA into the fabric of our organization.
Our R&D teams are already accelerating their work: our Target Discovery engines have delivered seven novel drug targets in just
one year. Our Manufacturing & Supply (M&S) teams use our AI-powered yield analytics platform, which assesses data trends from
past batches, recommends production parameter adjustments and optimizes raw material use to deliver consistently higher
yields. Across the value chain — from demand planning to quality assurance (QA) — AI-driven automation is being deployed to
boost productivity and agility. AI tools like the Inventory Optimizer, Launch Agent, and Quality Agent are being used to enable
faster, smarter decisions, from allocating production batches, to de-bottlenecking QA workflows, to optimizing launch plans for
success. Our Portfolio Strategy teams are using our enterprise AI layer, Plai, for predictions and strategic recommendations to
make the right decisions about our treatments to maximize patient impact.
In recent years, we have achieved key AI milestones across the business:
•in partnership with Aily Labs GmbH, we deployed the internal application Plai. Plai aggregates internal data across all functions
and harnesses the power of AI to provide timely insights and personalized “what if” development scenarios to support
informed decision-making. Today, over 22,000 of our employees use Plai for day-to-day decision making;
•the expansion of our accelerators continued with the official announcement of our Digital Manufacturing & Supply (M&S)
Accelerator, and talent growth in both our R&D and M&S accelerators;
•in research, we have built multiple AI programs seeking to reduce research lead-times through improved predictive modelling
and automated time-sink activities, enabling our R&D teams to scale and accelerate research processes. Initial results suggest
potential improvements in target identification efficiency in therapeutic areas like immunology, oncology and neurology,
though actual results may vary and are subject to ongoing validation;
•in Manufacturing & Supply, we have developed an in-house AI-enabled yield optimization solution called SimpLY, which learns
from past and current batch performance in an effort to enable consistently higher yield levels. This optimizes usage of raw
materials, supports our environmental efforts, and enhances our cost efficiency. At our sites in France and Singapore, SimpLY
analyzed over 13,000 batch runs of our anticoagulant (Lovenox/Clexane), enabling process optimizations that we estimate to
have generated approximately €10 million in annual cost savings based on our internal analysis of batch performance
improvements at these sites. Actual savings may vary and are subject to ongoing operational factors;
•we have partnered with FormationBio and OpenAI to develop AI-powered software to accelerate drug development, create
custom drug development lifecycle solutions and bring new medicines to patients more efficiently: these AI-powered digital
products rely on advanced AI models to create rich, multidimensional patient profiles, pinpoint outreach channels, and
generate IRB-ready, personalized content – nearly instantly and at scale;
•in 2025, we held a Digital Month that engaged over 20,000 of our employees worldwide, with the aim of continuing to
empower and inform people across our organization and drive adoption of our Digital and AI tools;
•Sanofi's internal GenAI tools are maturing rapidly: Concierge (launched in October 2024) provides access to over 20,000 data
points, supports over 30,000 users and has enabled two hours weekly saved on average per user; and
• approximately 7,000 of Sanofi employees received training via GenAI courses on SanofiU, our in-house learning platform.
4) Reinvent how we work
Transformation and simplification have started, with the aim of increasing empowerment and accountability. To drive
implementation of our culture built on stronger focus, inclusivity and teamwork, we have streamlined our executive leadership
team around 13 members. The complete Sanofi Executive Committee now includes the three managers who head up our Global
Business Units (Specialty Care, General Medicines, and Vaccines) as well as the heads of each of the following support functions:
Research and Development; Manufacturing & Supply; Finance; People & Culture; Digital; Legal, Business Integrity & Global
Security; Corporate Affairs; and Business Operations.
In 2025, as part of the streamlining of our focus, we announced the closing of the sale to CD&R of a 50.0% controlling stake of
our consumer healthcare business, Opella. We retain a significant shareholding in Opella with a 48.2% stake. Sanofi received total
net cash proceeds of around €10 billion. For more information on the transaction, see "— B.3 Opella."
We introduced an updated sustainability strategy in 2025, focused on the critical nexus between health and the environment.
Our strategic focus recognizes that 70% of our medicine and vaccine portfolio and more than 75% of our pipeline target diseases
are impacted by climate and environmental challenges. The AIR strategy is threefold: Access to healthcare; Impact on the
environment; and Resilient healthcare systems. It aims to:
i.expand access to care for conditions affected by environmental challenges;
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ITEM 4. Information on the Company |
ii.reduce the environmental impact of our products and activities, while adapting to environmental changes; and
iii.change the delivery of care through treatments and efforts that reduce the environmental footprint of healthcare systems.
Capital allocation policy
We will continue to pursue our focused and disciplined capital allocation policy. Our priorities in deploying the cash generated
from our operations are, in the following order: (i) investment in organic growth; (ii) business development and merger &
acquisition activities, focusing on bolt-on, value-enhancing opportunities to drive scientific and commercial leadership in core
therapeutic areas; (iii) growing the annual dividend; and (iv) anti-dilutive share buybacks. We also have the potential to raise
capital through asset disposals, including streamlining “tail” brands in our established products business.
B.2. Biopharma segment
The sections below provide additional information on our main medicines. Our intellectual property rights over our biopharma
medicines are material to our operations and are described at “B.6. Patents, Intellectual Property and Other Rights” below. As
indicated in note D.22. to the consolidated financial statements, included at Item 18. of this annual report, we are involved in
significant litigation concerning the patent protection of a number of these medicines. For more information on sales
performance in 2025, see “Item 5. Operating and Financial Review and Prospects — A. Operating Results.”
Immunology
Dupixent
Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13
(IL-13) pathways and is not an immunosuppressant. Dupilumab is jointly developed by Sanofi and Regeneron
Pharmaceuticals, Inc. (Regeneron) under a global collaboration agreement. To date, dupilumab has been studied across more
than 59 completed studies and 23 ongoing studies, involving more than 12,000 patients with various chronic diseases driven in
part by type 2 inflammation. The dupilumab development program has shown significant clinical benefit and a decrease in type 2
inflammation in Phase 3 studies, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays
a major role in multiple inflammatory diseases such as atopic dermatitis (AD), asthma, chronic rhinosinusitis with nasal polyposis,
eosinophilic esophagitis and prurigo nodularis. Dupixent comes in either a pre-filled syringe for use in a clinic or at home by
self-administration as a subcutaneous injection or in a pre-filled pen for at-home administration, providing patients with a more
convenient option. Dupixent is available in all major markets including the US (since April 2017), most European Union countries
(the first launch was in Germany in December 2017), Japan (since April 2018), and China (since June 2020).
Atopic dermatitis (AD)
Moderate-to-severe AD, a form of eczema and a chronic inflammatory disease, is characterized by rashes that sometimes cover
much of the body and can include intense, persistent itching and skin dryness, cracking, redness, crusting and oozing. 85% to
90% of patients first develop symptoms before five years of age, which can often continue through adulthood.
In 2014, the FDA also granted Dupixent Breakthrough Therapy designation, and after a Priority Review evaluation, it granted
Dupixent marketing authorization in March 2017 for the treatment of adults with moderate-to-severe AD whose disease is not
adequately controlled with topical prescription therapies, or when those therapies are not advisable. In 2016, the FDA granted
Dupixent Breakthrough Therapy designation for adolescent patients aged 12 to 17 years and in March 2019, the FDA extended the
marketing authorization to cover this age group.
In 2016, the FDA granted Breakthrough Therapy designation for Dupixent for the treatment of severe AD in children aged
six months to 11 years. On May 26, 2020, Dupixent was approved as the first biologic medicine for children aged 6 to 11 years with
moderate-to-severe AD. Having accepted Dupixent for Priority Review in February 2022, the FDA approved Dupixent on June 7,
2022 for children aged six months to five years with moderate-to-severe AD whose disease is not adequately controlled with
topical prescription therapies or when those therapies are not advisable, making Dupixent the first biologic medicine to
significantly reduce signs and symptoms in children as young as six months.
The EC approved Dupixent in September 2017 for use in adults with moderate-to-severe AD who are candidates for systemic
therapy, and extended the marketing authorization in August 2019 to include adolescents aged 12 to 17 years. On November 30,
2020, the EC extended the marketing authorization to children aged 6 to 11 years with severe AD and on June 28, 2021, the
Dupixent label was updated with long-term data for up to three years, reinforcing the medicine’s well-established safety profile in
adults with moderate-to-severe AD. On January 27, 2023 the Committee for Medicinal Products for Human Use (CHMP) adopted
a positive opinion for Dupixent, recommending expanded approval in the EU to treat severe AD in children aged six months to
five years who are candidates for systemic therapy. In March 2023, Dupixent was approved by the EC as the first and only
targeted medicine for children as young as six months old with severe AD.
On January 22, 2018, the Ministry of Health, Labor and Welfare (MHLW) in Japan granted marketing and manufacturing
authorization for Dupixent for the treatment of AD in adults not adequately controlled with existing therapies. More recently, on
September 25, 2023 Dupixent was approved in Japan to treat patients aged six months and older with moderate-to-severe AD.
On June 19, 2020, the National Medical Products Administration (NMPA) in China approved Dupixent for adults for the treatment
of moderate-to-severe AD after identifying dupilumab as an overseas medicine regarded as urgently needed in clinical practice,
leading to an expedited review and approval process.
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In April 2023, new abstract data from a long-term efficacy open-label study presented at the Revolutionizing Atopic Dermatitis
(RAD) 2023 Spring Conference in Washington, DC showed that Dupixent demonstrated robust and sustained efficacy with
progressive improvement of AD signs and symptoms in patients with moderate-to-severe AD who completed up to five years of
treatment: the longest duration of data for any biologic medicine in this disease. Additionally, the long-term safety data from a
52-week open-label extension study in children aged six months to five years reinforced the well-established safety profile of
Dupixent observed across all other approved age groups. These data build on the existing evidence supporting the selective way
Dupixent inhibits IL4/IL-13 pathways, both key and central drivers of type 2 inflammation, thereby significantly improving
itching and skin lesions and other important measures that impact a patient’s quality of life. The inclusion of the results from the
five-year OLE study for adults in the Dupixent label was approved in Europe in June 2023, and in the US by the FDA in
October 2023.
In March 2023, positive results from the clinical study assessing Dupixent in adults and adolescents with uncontrolled
moderate-to-severe atopic hand and foot dermatitis were presented in a late-breaking session, one of more than 20 Dupixent
scientific presentations, at the American Academy of Dermatology (AAD) 2023 Annual Meeting. The study, evaluating a biologic
for this difficult-to-treat population, met its primary and key secondary endpoints. In August 2023, the clinical section of the
Dupixent label in Europe was updated to include the hand and foot dermatitis population. In January 2024, the Dupixent US
label was updated with data further supporting use in AD with moderate-to-severe hand and foot involvement.
These Phase 3 data are from the first and only study evaluating a biologic specifically for this difficult-to-treat population and
have also been added to the Dupixent label in the European Union, with regulatory submissions under way in additional
countries.
Asthma
Dupixent was granted marketing authorization by the FDA in October 2018 as an add-on maintenance therapy in patients with
moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent
asthma. In May 2019, the EC approved Dupixent for use as an add-on maintenance treatment in severe asthma patients aged
12 years and older with type 2 inflammation whose symptoms are inadequately reduced by other treatments.
In September 2020, new long-term data from a Phase 3 open-label extension study showed sustained improvement in lung
function and reduction in severe exacerbations in adults and adolescents with moderate-to-severe asthma. On May 17, 2021,
detailed results from a Phase 3 study showed Dupixent significantly reduced severe asthma attacks, and within two weeks rapidly
improved lung function in children aged six to 11 years with uncontrolled moderate-to-severe asthma with evidence of type 2
inflammation. Moreover, Dupixent significantly improved overall asthma symptom control and reduced an airway biomarker of
type 2 inflammation, called fractional exhaled nitric oxide (FeNO), that plays a major role in asthma.
In October 2021, the FDA approved Dupixent as an add-on maintenance treatment for patients aged six to 11 years with
moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma, thereby
bringing a new treatment for children who may be suffering from life-threatening asthma attacks and poor lung function
affecting their ability to breathe, which could potentially continue into adulthood. On April 7, 2022, the EC approved Dupixent for
use in children aged six to 11 years as an add-on maintenance treatment for severe asthma with type 2 inflammation
characterized by raised blood eosinophils and/or raised FeNO, whose symptoms are inadequately reduced with medium to high
dose inhaled corticosteroids (ICS) plus another medicine for maintenance treatment.
In March 2019, Dupixent was approved in Japan for treating patients aged 12 years and over with severe or refractory asthma
whose symptoms are inadequately controlled with existing therapies.
In addition, in December 2025, Japan granted marketing and manufacturing authorization for Dupixent for the treatment of
bronchial asthma in children aged 6 to 11 years with severe or refractory disease whose symptoms are inadequately controlled
with existing therapy.
In November 2023, Dupixent received approval in China for treatment of moderate to severe asthma patients aged 12 years and
over with type 2 inflammation.
In February 2024, topline results from the VESTIGE Phase 4 clinical study were presented at the 2024 American Academy of
Allergy, Asthma, and Immunology Annual Meeting. This study evaluated the effects of Dupixent on airway remodeling in adults
with uncontrolled moderate-to-severe asthma characterized by an eosinophilic phenotype or those dependent on oral
corticosteroids.
In 2024, Sanofi initiated a Phase 3 study for children aged two to six years suffering from asthma. This parallel, two-arm Phase 3
study aims to evaluate the efficacy and long-term safety of dupilumab treatment in children with uncontrolled asthma and/or
recurrent severe asthmatic wheeze.
Chronic rhinosinusitis with nasal polyposis (CRSwNP)
CRSwNP is a chronic disease of the upper airway that obstructs the sinuses and nasal passages. It can lead to breathing
difficulties, nasal congestion and discharge, reduced or loss of sense of smell and taste, and facial pressure.
In June 2019, the FDA approved Dupixent for use with other medicines to treat CRSwNP in adults whose disease is not controlled.
In October 2019, the EC approved Dupixent for use as an add-on therapy with intranasal corticosteroids in adults with severe
CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. In
March 2020, the Japanese Pharmaceuticals and Medical Devices Agency approved Dupixent as add-on maintenance treatment
for adults with inadequately controlled CRSwNP.
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In September 2024, the FDA approved Dupixent as an add-on maintenance treatment for adolescent patients aged 12 to 17 years
with inadequately controlled CRSwNP, expanding the initial FDA approval in CRSwNP from June 2019 for patients aged 18 years
and older. The FDA evaluated Dupixent for this expanded indication under Priority Review, which is reserved for medicines that
represent potentially significant improvements in efficacy or safety in treating serious conditions.
Eosinophilic esophagitis (EoE)
EoE is a chronic and progressive inflammatory disease that damages the esophagus and prevents it from working properly;
swallowing even small amounts of food can be a painful and worrisome choking experience. In severe cases, a feeding tube may
be the only option to ensure proper calorific intake and adequate nutrition. As the disease progresses, patients may continue to
experience symptoms despite multiple treatments.
On September 14, 2020, the FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients aged
12 years and older with EoE, and subsequently accepted the file for Priority Review on April 4, 2022. On May 20, 2022, the FDA
approved Dupixent to treat patients with EoE aged 12 years and older. With this approval, Dupixent became the first and only
medicine specifically indicated to treat EoE in the US.
On December 16, 2022, the European Medicines Agency (EMA)'s CHMP adopted a positive opinion, recommending the approval
of dupilumab in the EU to treat adults and adolescents with EoE. On January 30, 2023, the EC expanded the marketing
authorization for Dupixent in the EU to include the treatment of EoE in adults and adolescents aged 12 years and older.
On July 14, 2022, a Dupixent Phase 3 study showed positive results in children aged one to 11 years with EoE, making this the fifth
pediatric pivotal study across three type 2 inflammatory diseases to reinforce the well-established efficacy and safety profile of
Dupixent. In January 2024, Dupixent was approved by the FDA for the treatment of adult and pediatric patients aged one year or
older, weighting at least 15 kilograms, with EoE. The EoE pediatric indication was approved in the EU in November 2024.
Prurigo nodularis (PN)
Prurigo nodularis is a chronic, debilitating skin disease with underlying type 2 inflammation and has one of the highest impacts on
a patient’s quality of life among inflammatory skin diseases due to the extreme itching it causes. People with PN experience
intense, persistent itching, with thick skin lesions (called nodules) that can cover most of the body. The disease is often painful –
with burning, stinging and tingling of the skin – and can negatively affect mental health, daily living activities and social
interactions. High-potency topical steroids are commonly prescribed but are associated with safety risks if used long-term.
The FDA evaluated the Dupixent application for PN under Priority Review on May 31, 2022. On September 29, 2022, the FDA
approved Dupixent for the treatment of adult patients with PN. With this approval, Dupixent became the first and only medicine
specifically indicated to treat PN in the US. The FDA approval was based on data from two Phase 3 studies evaluating the efficacy
and safety of Dupixent in adults with PN. Efficacy in these studies assessed the proportion of subjects with clinically meaningful
reduction in itching, clearing of skin, or both. On December 15, 2022, the EC expanded the marketing authorization for Dupixent
in the EU to treat adults with moderate-to-severe PN who are candidates for systemic therapy, after the previous positive
recommendation on November 11, 2022.
The Dupixent PN indication was approved in Japan on June 26, 2023, and in China on September 22, 2023.
Chronic spontaneous urticaria (CSU)
CSU is a chronic inflammatory skin disease characterized by the sudden onset of hives on the skin and/or swelling deep under
the skin. Despite standard-of-care treatment, people with CSU often experience symptoms including a persistent itching or
burning sensation, which can be debilitating and significantly impact quality of life. Swelling often occurs on the face, hands and
feet, but can also affect the throat and upper airways.
On July 29, 2021 a pivotal Phase 3 study evaluating Dupixent in patients with moderate-to-severe CSU met its primary
endpoints and all key secondary endpoints at 24 weeks. Adding Dupixent to standard-of-care antihistamines significantly
reduced itching and hives for biologic-naive patients, compared to those treated with antihistamines alone (placebo) in Study A
(the first of three studies) of the LIBERTY CUPID clinical program.
Study B evaluated Dupixent in adults and adolescents who remain symptomatic despite standard-of-care antihistamine
treatment and are intolerant or incomplete responders to an anti-IgE therapeutic (omalizumab). Although positive numerical
trends in reducing itching and hives were observed, the study met futility criteria in the pre-specified interim analysis. Further
analysis following blinded completion of the study demonstrated that Dupixent met the EU primary endpoint (UAS7 at week 24).
The safety data were generally consistent with the known safety profile of Dupixent in its approved indications. In
December 2022, Dupixent was submitted to the FDA for the CSU indication. In October 2023, the FDA issued a Complete
Response Letter (CRL) stating that additional efficacy data were required to support approval; it did not identify any issues with
safety or manufacturing. Accordingly, a third clinical study (Study C) was initiated to provide additional efficacy data.
In September 2024, the Dupixent confirmatory Phase 3 study (LIBERTY-CUPID Study C) met the primary and key secondary
endpoints for the investigational treatment of patients with uncontrolled, biologic-naive CSU receiving background therapy with
antihistamines. This positive study confirmed results from Study A, but failed to meet the ex-EU primary endpoint (ISS at week
24). Earlier in 2024, Japan was the first country in the world to approve and launch Dupixent for adult and adolescent CSU
patients based on the results from Study A (February 2024), followed by approvals in the United Arab Emirates (September
2024), Brazil (November 2024), the US (April 2025), and the Kingdom of Saudi Arabia (KSA) (October 2025).
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ITEM 4. Information on the Company |
Chronic obstructive pulmonary disease (COPD)
COPD is a progressive respiratory disorder that damages the lungs and reduces lung function, making it the fourth leading cause
of death worldwide. Key symptoms include persistent coughing, excessive mucus production, and shortness of breath, which can
significantly affect daily activities and contribute to sleep disturbances, anxiety, and depression. COPD also imposes a major
health and economic burden due to frequent acute exacerbations, often requiring treatment with systemic corticosteroids
and/or antibiotics, and hospitalizations when severe. Exacerbations are also associated with lung function decline and worsened
clinical burden and outcomes in a vicious cycle. While smoking and exposure to harmful particles are primary risk factors, the
disease may still progress in those who have quit smoking.
Around 50% of COPD patients continue to experience exacerbations despite receiving triple inhaled therapy. In the US,
approximately 300,000 individuals have inadequately controlled COPD with Type 2 Inflammation (also known as eosinophilic
phenotype), a subgroup prone to a 30% increase in exacerbations and a higher risk of COPD-related hospital readmissions within
a year.
On July 3, 2024, following a positive review by the EMA, the EC approved Dupixent as an add-on maintenance treatment for
adults with uncontrolled COPD characterized by elevated blood eosinophils. This approval covers patients already on a
combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist
(LAMA), or those on a LABA/LAMA combination if ICS is unsuitable. The EC was the first regulatory agency worldwide to grant
approval for Dupixent in COPD patients.
On September 10, 2024, a pooled analysis from the BOREAS and NOTUS Phase 3 studies showed that Dupixent reduced
exacerbations and improved lung function and quality of life compared to placebo in adults with uncontrolled COPD and
evidence of type 2 inflammation (i.e. raised blood eosinophils). The results were presented for the first time, in collaboration with
Regeneron, at the 2024 European Respiratory Society (ERS) International Congress.
On September 27, 2024, the NMPA in China also approved Dupixent as an add-on treatment for adults with uncontrolled COPD
and raised blood eosinophils. This approval similarly covers patients on combinations of ICS, LABA, and LAMA, or LABA and LAMA
if ICS is not appropriate. Dupixent has now been approved for the treatment of COPD in over 30 countries, including the 27 EU
member states.
On September 27, 2024, the FDA approved Dupixent as the first biologic treatment for COPD in the US. This approval, which
applies to adults with inadequately controlled COPD and an eosinophilic phenotype, was based on two pivotal Phase 3 studies
showing significant reductions in exacerbations and improvements in lung function and quality of life compared to placebo.
Dupixent has become the leading biologic in new-to-brand prescriptions across all its FDA-approved indications and is the most
prescribed biologic by US pulmonologists.
As of October 2025, Dupixent had been approved for COPD in 53 countries and launched across 17 markets including the US,
Germany, China and Japan.
Bullous pemphigoid (BP)
BP is a chronic, debilitating and relapsing skin disease. It affects approximately 52,000 adults in the US, and is characterized by
intense itch and blisters, reddening of the skin and painful lesions. It can be chronic and relapsing with underlying type 2
inflammation, and primarily affects elderly patients. The blisters and rash can form over much of the body and cause the skin to
bleed and crust, resulting in patients being more prone to infection and affecting their daily functioning. Available treatment
options are limited and can add to overall disease burden by suppressing a patient’s immune system.
In June 2025, Dupixent (dupilumab) was approved in the US as the only targeted medicine to treat patients with BP. The FDA
approval was based on data from the pivotal Phase 2/3 ADEPT trial that evaluated the efficacy and safety of Dupixent compared
to placebo in adults with moderate-to-severe BP.
ADEPT was a randomized, Phase 2/3, double-blind, placebo-controlled trial evaluating the efficacy and safety of Dupixent in 106
adults with moderate-to-severe BP for a 52-week treatment period. After randomization, patients received Dupixent or placebo
every two weeks after an initial loading dose, along with oral corticosteroids (OCS) treatment. During treatment, OCS taper was
initiated after patients experienced two weeks of sustained control of disease activity. OCS tapering could start between four to
six weeks after randomization and was continued if disease control was maintained, with the intent of completion by 16 weeks.
After OCS tapering, patients were only treated with Dupixent or placebo for at least 20 weeks, unless rescue treatment was
required.
The primary endpoint evaluated the proportion of patients achieving sustained disease remission at 36 weeks. Sustained disease
remission was defined as complete clinical remission with completion of OCS taper by 16 weeks without relapse after completion
of the OCS taper and no rescue therapy use during the 36-week treatment period. Relapse was defined as the appearance of
three or more new lesions a month, or at least one large lesion or urticarial plaque (greater than 10 cm in diameter), that did not
heal within a week. Rescue therapy could include treatment with high-potency topical corticosteroids, OCS (including increase of
OCS dose during the taper or re-initiation of OCS after completion of the OCS taper), systemic non-steroidal immunosuppressive
medications or immunomodulating biologics.
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Life cycle management
Dupixent is currently being evaluated in clinical development programs for diseases that are driven by type 2 inflammation. These
include chronic pruritis of unknown origin (CPUO), eosinophilic gastroenteritis (EoG), ulcerative colitis (UC) and Lichen Simplex
Chronicus (LSC). See “— B.4. Global research & development.”
In August 2025, a supplemental biologics license application (sBLA) for Dupilumab for the Allergic Fungal Rhinosinusitis (AFRS)
indication, with a request for Priority Review, was submitted to the FDA and subsequently accepted for priority review in
November 2025 . The target action date for the FDA decision is February 28, 2026.
Dupixent is developed and commercialized in collaboration with Regeneron. For additional information on the collaboration,
see “Item 5. Operating and Financial Review and Prospects — A.1.7. Financial Presentation of Alliances — Alliance Arrangements
with Regeneron Pharmaceuticals, Inc. (Regeneron).”
Kevzara
Kevzara (sarilumab) is a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R) and has been shown to
inhibit IL-6R mediated signaling.
IL-6 is a multi-functional cytokine that acts as a critical signaling node in the complex pro-inflammatory cytokine network that
underpins rheumatoid arthritis (RA), Polymyalgia rheumatica (PMR) and other immune-mediated diseases. Kevzara has been
approved for RA in 39 countries. For the PMR indication, Kevzara has been approved in the US, EU, UK, Canada, and Israel. In
2024, the FDA approved Kevzara for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) , followed by the EU
and UK in 2025.
Kevzara is developed and commercialized in collaboration with Regeneron. For additional information, see “Item 5. Operating and
Financial Review and Prospects — A.1.7. Financial Presentation of Alliances — Alliance Arrangements with Regeneron
Pharmaceuticals, Inc. (Regeneron).”
Rheumatoid arthritis (RA)
RA is a chronic inflammatory autoimmune disease causing inflammation, pain, and eventually joint damage and disability. Kevzara
is approved in 39 countries for use in combination with disease modifying anti-rheumatic drugs (DMARDs) or as monotherapy for
the treatment of moderately to severely active RA in adult patients who respond inadequately or are intolerant to DMARDs or
tumour necrosis factor (TNF) antagonist.
In May 2017, the FDA approved Kevzara for the treatment of adult patients with moderately to severely active RA who have
responded inadequately to, or who are intolerant to one or more DMARDs.
In June 2017, the EC granted marketing authorization for Kevzara in combination with methotrexate for the treatment of
moderately to severely active RA in adult patients who have responded inadequately to – or who are intolerant to – one or more
DMARDs. Kevzara can be given as monotherapy in case of intolerance to methotrexate or when treatment with methotrexate is
inappropriate.
In September 2017, Kevzara obtained manufacturing and marketing approval in Japan as a treatment for RA not responding well
to conventional treatments.
Polymyalgia rheumatica (PMR)
PMR is a rheumatic inflammatory disorder characterized by pain and stiffness around the neck, shoulder and hip areas that leads
to significant decline in quality of life. Kevzara is approved for the treatment of adult patients with PMR in the US, Israel, EU, UK
and Canada.
In February 2023, the FDA approved Kevzara for the treatment of adult patients with PMR who have had an inadequate response
to corticosteroids or who cannot tolerate a corticosteroid taper.
In November 2024, the EC granted marketing authorization for Kevzara for the treatment of PMR in adult patients who have had
an inadequate response to corticosteroids, or who experience a relapse on a corticosteroid taper.
Polyarticular Juvenile Idiopathic Arthritis（pJIA）
Juvenile idiopathic arthritis (JIA) is an umbrella-term describing a heterogeneous group of conditions characterized by chronic
arthritis beginning before the age of 16 years, persisting for at least 6 weeks, and having no other identifiable cause. Polyarticular
JIA includes a blend of patients with a wide spectrum of etiologic risk factors, unique disease course, and therapeutic challenges.
In June 2024, the FDA approved Kevzara for treatment of active pJIA in patients who weigh 63 kilograms or more.
In January 2025, the EC granted marketing authorization for Kevzara for the treatment of active pJIA in patients aged two years
and older. Kevzara is indicated for those who have not responded adequately to previous therapies with conventional synthetic
DMARDs. Kevzara may be used as monotherapy or in combination with methotrexate. The treatment is administered as an
injection under the skin once every two weeks, and is effective in reducing inflammation and improving symptoms associated
with pJIA.
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ITEM 4. Information on the Company |
Rare diseases
Cerezyme
Cerezyme (imiglucerase) is an enzyme replacement therapy (ERT) used to treat Gaucher disease, a chronic, inherited, progressive
and potentially life-threatening lysossomal storage disorder (LSD). Gaucher disease is caused by a deficiency of the enzyme
glucocerebrosidase; this causes a fatty substance called glucosylceramide (also called GL-1) to build up in certain areas of the
body including the spleen, liver, and bone. Gaucher disease exhibits diverse manifestations, a broad range of onset of symptoms,
and a wide clinical spectrum of disease severity. It is estimated that Gaucher disease occurs in approximately one in
120,000 newborns in the general population and one in 850 in the Ashkenazi Jewish population worldwide, but incidence and
patient severity vary among regions. Cerezyme has been marketed in the US since 1994, in the EU since 1997, in Japan since 1998
and in China since 2008, and is approved to treat type 1 Gaucher disease in more than 85 countries. It has also been approved to
treat the systemic symptoms of type 3 Gaucher disease in most non-US markets, including the EU and Japan.
Cerdelga
Cerdelga (eliglustat) is the first and only first-line oral therapy for Gaucher disease type 1 adult patients. A potent, highly specific
ceramide analog inhibitor of GL-1 synthesis with broad tissue distribution, Cerdelga has demonstrated efficacy in the treatment
of naive Gaucher disease patients and in patients who switch from enzyme replacement therapy. Cerdelga has been approved to
treat type 1 Gaucher disease in the US (2014), and in the EU and Japan (2015). It is also in development for the treatment of type 1
Gaucher disease in pediatric patients. See “— B.4. Global Research & Development.”
Myozyme and Lumizyme
Myozyme (alglucosidase alfa) is an ERT used to treat both Infantile Onset and Late Onset Pompe disease (IOPD and LOPD).
Pompe disease is an inherited, progressive and often fatal neuromuscular disease, caused by a genetic deficiency or dysfunction
of the lysosomal enzyme acid alpha-glucosidase (GAA) that results in the build-up of glycogen in the muscles’ cells. For IOPD,
symptoms begin within a few months of birth and there are impacts on the heart in addition to causing skeletal muscle weakness.
Other symptoms include difficulties breathing, frequent chest infections, problems feeding that result in failure to gain weight as
expected, and failure to meet certain developmental milestones. Patients with LOPD typically present symptoms any time after
the first year of life to late adulthood and rarely manifest cardiac problems. The hallmark symptom of LOPD is skeletal muscle
weakness, which often leads to walking disability and reduced respiratory function. Patients often require wheelchairs to assist
with mobility and may require mechanical ventilation to help with breathing. Pompe disease occurs in approximately one in
40,000 newborns worldwide, but incidence and patient severity vary among regions.
Myozyme was first approved in 2006 in the EU and has since been approved in more than 80 countries. In the US, alglucosidase
alfa has been marketed as Lumizyme since 2010.
Nexviazyme/Nexviadyme
Nexviazyme/Nexviadyme (avalglucosidase alfa-ngpt) is a novel mannose-6-phosphate (M6P) enriched ERT treatment designed
as a monotherapy for the entire spectrum of infantile-onset and late-onset Pompe disease (IOPD, LOPD), including patients who
have changed treatments and naive patients, who have not received treatment previously. Nexviazyme/Nexviadyme is
scientifically designed to specifically target the M6P receptor, the key pathway for ERT, to effectively clear glycogen build-up in
muscle cells. It helps replace the GAA enzyme for people whose bodies do not produce enough. Investment in the clinical
development of Nexviazyme is continuing, with an ongoing Phase 3 study in treatment-naive IOPD patients aged less than
12 months. Nexviazyme/Nexviadyme is administered as a monotherapy every two weeks.
Nexviazyme was first approved in the US by the FDA on August 6, 2021 for LOPD patients aged one year and older. On June 24,
2022, the EC granted marketing authorization for Nexviadyme as a potential new standard of care for the long-term treatment of
both LOPD and IOPD. Nexviazyme/Nexviadyme has been approved in more than 59 countries and successfully launched in
32 countries including the US, Germany, the UK, other European markets, Japan and Australia. In all launched markets, the vast
majority of eligible patients are currently being treated with Nexviazyme/Nexviadyme.
Fabrazyme
Fabrazyme (agalsidase beta) is an ERT used to treat Fabry disease (FD). FD is a multisystemic, progressive, X-linked inherited
disorder of glycosphingolipid metabolism due to deficient or absent lysosomal α-galactosidase A activity resulting in progressive
globotriaosylceramide (GL-3) accumulation in the lysosomes of various tissues. FD affects both genders. With age, progressive
organ damage develops, leading to potentially life-threatening renal, cardiac and/or cerebrovascular complications. FD is
characterized by different symptom severities and rates of progression, ranging from classic disease with early symptom onset to
non-classic disease with cardiac and/or renal complications later in life. FD is seen in all racial and ethnic groups and is an
under-diagnosed condition. Prevalence estimates vary across regions. Classic FD mutations are estimated to be approximately
1:40,000 in males with more wide-ranging estimates for non-classic in both males and females. Fabrazyme has been marketed in
the EU since 2001 and in the US since 2003 and is approved in more than 70 countries.
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ITEM 4. Information on the Company |
Aldurazyme
Aldurazyme (laronidase) is the only approved ERT for mucopolysaccharidosis type 1 (MPS I), an inherited lysosomal storage
disorder caused by a deficiency of alpha-L-iduronidase, a lysosomal enzyme normally required for the breakdown of certain
complex carbohydrates known as glycosaminoglycans (GAGs). MPS I is multi-systemic, and children with MPS I are described as
having either a severe or attenuated form of the disorder based on age of onset, severity of symptoms, rate of disease
progression and whether there is early and direct involvement of the brain. MPS I occurs in approximately one per 100,000 live
births worldwide, but incidence and patient severity vary among regions. Sanofi markets Aldurazyme in the EU and the US (since
2003) and in more than 75 other countries.
Xenpozyme
Xenpozyme (olipudase alfa) is an ERT designed to replace deficient or defective acid sphingomyelinase (ASMD), an enzyme that
allows for the breakdown of the lipid sphingomyelin. In individuals with ASMD, an insufficiency of the ASM enzyme means
sphingomyelin is poorly metabolized, potentially leading to lifelong accumulation in and damage to multiple organs.
The significance of the unmet need that Xenpozyme addresses has been recognized by Japan’s PMDA with Sakigake designation,
by the EU with PRIME designation, and by the FDA with Breakthrough designation.
Xenpozyme was approved first in Japan on March 28, 2022, followed by Europe on June 24, 2022 and the US on August 31, 2022.
Xenpozyme is the first and only ERT for the treatment of non-central nervous system manifestations of ASMD, with
demonstrated improvements in hepatosplenomegaly, pulmonary, liver and hematologic function, dyslipidemia, and growth
(children only) in clinical studies of adults and children with ASMD. Xenpozyme is given as an intravenous infusion once every two
weeks, and the dose is based on body weight.
Xenpozyme has to date been commercialized in 26 countries, however only 15 of those have full reimbursement by payers. By
2030, it is anticipated that Xenpozyme will have been launched in many additional markets worldwide.
Wayrilz
Wayrilz (rilzabrutinib) is the first oral reversible Bruton’s tyrosine kinase (BTK) inhibitor for immune thrombocytopenia (ITP) that
helps address the root cause of disease through multi-immune modulation. BTK, expressed in B cells, macrophages and other
innate immune cells, plays a critical role in multiple immune-mediated disease processes and inflammatory pathways. With the
application of Sanofi’s TAILORED COVALENCY technology, Wayrilz can selectively inhibit the BTK target while potentially
reducing the risk of off-target side effects.
Wayrilz is being studied across a variety of rare or inflammatory diseases, including warm autoimmune hemolytic anemia (wAIHA),
IgG4-related disease (IgG4-RD), and sickle cell disease (SCD). These additional indications are currently under investigation and
have not been approved by regulatory authorities.
ITP is a disease of complex immune dysregulation that causes low platelet counts (less than 100,000/μL), resulting in a variety of
bleeding symptoms and high risk of thromboembolism. Beyond bruising and bleeding, which can include potentially life-
threatening episodes like intracranial hemorrhage, people living with ITP may experience reduced quality of life, including
physical fatigue and cognitive impairment.
The FDA has approved Wayrilz for adults with persistent or chronic ITP who have had an insufficient response to a previous
treatment. The approval was based on the pivotal LUNA 3 Phase 3 study, in which Wayrilz met the primary and secondary
endpoints, showing a positive impact on sustained platelet counts and other ITP symptoms, like fatigue. Wayrilz has also been
approved in the United Arab Emirates. The EC has approved Wayrilz as a new treatment for ITP in adult patients who are
refractory to other treatments, following a positive opinion from the European Medicines Agency's Committee for Medicinal
Products for Human Use (CHMP). Wayrilz has received Fast Track and Orphan Drug Designations (ODD) from the FDA for ITP,
with similar orphan designations in Japan and the EU. Most recently, the FDA has granted Wayrilz an ODD for three additional
rare diseases: wAIHA, IgG4-RD, and SCD. Wayrilz has also received FDA Fast Track Designation in IgG4-RD and wAIHA, and
European Medicines Agency orphan designation in IgG4-RD.
ALTUVIIIO
ALTUVIIIO (Antihemophilic Factor Recombinant, Fc-VWF-XTEN Fusion Protein) is a first-in-class high-sustained factor VIII
therapy that is designed to extend protection from bleeds with once-weekly prophylactic dosing for adults and children with
hemophilia A. Hemophilia A is a rare, x-linked genetic bleeding disorder characterized by a deficiency of functional coagulation
factor VIII, resulting in a prolonged patient plasma-clotting time. As a consequence, people with hemophilia A bleed for a longer
time than normal.
ALTUVIIIO temporarily replaces the missing coagulation factor VIII by intravenous injection. In adults and adolescents, it is the
first factor VIII therapy that has been shown to break through the von Willebrand factor ceiling, which imposes a half-life
limitation on earlier generation factor VIII therapies. ALTUVIIIO builds on innovative Fc fusion technology by adding a region of
von Willebrand factor and XTEN polypeptides to extend its time in circulation.
ALTUVIIIO was first approved in February 2023 by the FDA, which had previously granted Breakthrough Therapy designation in
May 2022 (the first factor VIII therapy to receive this designation); fast-track designation in February 2021; and Orphan Drug
designation in 2017. ALTUVIIIO has since been approved the by regulatory authorities in Canada, Japan, Taiwan, Macau and Hong
Kong, and has been commercialized in Japan and Taiwan. The European Commission (EC) granted Orphan Drug designation in
June 2019 and a marketing authorization application was filed with the European Medicines Agency (EMA) in May 2023.
ALTUVOCT (the brand name of ALTUVIIIO in Europe) received EC marketing authorization in June 2024.
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ALTUVIIIO is developed and commercialized in collaboration with Swedish Orphan Biovitrum AB (Sobi), whose territories include
Europe, Russia, the Middle East, and some countries in North Africa.
Eloctate
Eloctate (Antihemophilic Factor Recombinant, Fc fusion protein) is an extended half-life factor VIII therapy clotting-factor
therapy to control and prevent bleeding episodes in adults and children with hemophilia A. In the US, it is indicated for use in
adults and children with hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of
bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.
Eloctate temporarily replaces the missing coagulation Factor VIII by intravenous injection.
We market Eloctate primarily in the US (since 2014), Japan, Canada, Australia, South Korea, Taiwan and Hong Kong/Macau.
Eloctate is developed and commercialized in collaboration with Sobi, whose territories include Europe, Russia, the Middle East,
and some countries in North Africa.
Alprolix
Alprolix (coagulation Factor IX recombinant, Fc fusion protein) is an extended half-life factor IX clotting-factor therapy to control
and prevent bleeding episodes in adults and children with hemophilia B. In the US, it is indicated for use in adults and children
with hemophilia B for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and
routine prophylaxis to reduce the frequency of bleeding episodes.
Hemophilia B is a rare, x-linked genetic bleeding disorder characterized by a deficiency of functional coagulation Factor IX,
resulting in a prolonged patient plasma-clotting time. As a consequence, people with hemophilia B bleed for a longer time than
normal. Alprolix temporarily replaces the missing coagulation Factor IX by intravenous injection.
We market Alprolix primarily in the US (since 2014), Japan, Canada, Australia, New Zealand, South Korea, Taiwan and
Hong Kong/Macau.
Alprolix is developed and commercialized in collaboration with Sobi, whose territories include Europe, Russia, the Middle East, and
some countries in North Africa.
Qfitlia
Qfitlia (fitusiran) is a first-in-class antithrombin lowering therapy indicated for routine prophylaxis to prevent or reduce the
frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without
factor VIII or IX inhibitors. Hemophilia A and B are rare, x-linked genetic bleeding disorders characterized by a deficiency of
functional coagulation factor VIII or IX, respectively, resulting in a prolonged patient plasma-clotting time. Consequently, people
with hemophilia A or B bleed for a longer time than normal.
Qfitlia is a small interfering RNA therapeutic designed to lower antithrombin, a protein that inhibits blood clotting, with the goal of
promoting thrombin generation to rebalance hemostasis and prevent bleeds. Qfitlia utilizes Alnylam Pharmaceutical, Inc.’s
ESC-GalNAc conjugate technology, which enables subcutaneous dosing every other month. It is administered via subcutaneous
injection with a convenient, prefilled pen for the 50 mg dose.
Qfitlia has received approval from the FDA, which had previously granted it Breakthrough Therapy designation, Fast Track
designation and Orphan Drug designation. Qfitlia has also been approved by regulatory authorities in the UAE, Macao and China.
Qfitlia is sold under license from Alnylam Pharmaceuticals, Inc.
Cablivi
Cablivi (caplacizumab) is a bivalent anti-von Willebrand Factor (vWF) NANOBODY® VHH for the treatment of patients
experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP). Depending on the country, Cablivi is
approved in adults only or in adults and pediatric population aged 12 years and above. Cablivi is the first and a best-in-class
treatment reducing aTTP morbidities and mortality to improve and save lives. Cablivi treatment results in the inhibition of
microthrombi formation and preventing organ damage.
Acquired thrombotic thrombocytopenic purpura is an ultra-rare (3.5-4.5 episodes per million of population), life-threatening,
autoimmune-based blood clotting disorder characterized by extensive clot formation in small blood vessels throughout the body,
leading to severe thrombocytopenia (very low platelet count); microangiopathic hemolytic anemia (loss of red blood cells through
destruction); ischemia (restricted blood supply to parts of the body); and widespread organ damage, especially in the brain and
heart.
Cablivi was granted marketing authorization in Europe by the EC in September 2018; in the US by the FDA in February 2019; and in
Japan by the Japanese Pharmaceutical and Medical Devices Agency (PMDA) in September 2022. Cablivi is currently
commercially available in 28 countries including the US, the majority of European countries, Switzerland, Brazil, Colombia, Japan
and five Greater Gulf region states. Recently, Cablivi obtained Regulatory BLA approval in China following priority review.
Additional commercial launches are ongoing.
Cablivi was developed by Ablynx, a Sanofi company since mid-2018.
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Ayvakit/Ayvakyt
Ayvakit/Ayvakyt (generic name: avapritinib) is a small-molecule tyrosine kinase inhibitor (TKI) that works by selectively inhibiting
mutant forms of KIT (D816V mutation) and PDGFRA (platelet-derived growth factor receptor alpha; D842V mutation) kinases.
Ayvakit/Ayvakyt has been indicated for treatment of adults with unresectable, metastatic gastrointestinal stromal tumors (GIST),
and with advanced and indolent systemic mastocytosis (SM). The FDA has granted three breakthrough therapy designations to
Ayvakit. The medicine has received orphan drug designations from the FDA and orphan medicinal product designations from the
EMA for the treatment of advanced and indolent systemic mastocytosis and unresectable or metastatic GIST.
Ayvakit was first approved by the FDA in January 2020 for the treatment of adults with unresectable or metastatic GIST
harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations. PDGFRA exon 18 mutations, including the PDGFRA
D842V mutation, are primary drivers of disease in a subset of patients with GIST. Ayvakit is the only approved medicine for
patients with PDGFRA D842V-driven GIST. The medicine received EMA conditional marketing authorization as Ayvakyt for the
treatment of adults with unresectable or metastatic GIST harboring a PDGFRA D842V mutation in September 2020.
Ayvakit was FDA approved for the treatment of adults with advanced SM in June 2021 and indolent SM (ISM) in May 2023. The
medicine received EMA approval under the brand name Ayvakyt for the treatment of adults with advanced SM, including
aggressive SM (ASM), SM with an associated hematological neoplasm (SM-AHN) or mast cell leukemia (MCL), after at least one
systemic therapy, and adults with ISM with moderate to severe symptoms inadequately controlled on symptomatic treatment. It
is the only medicine approved across the spectrum of advanced and indolent systemic mastocytosis (SM). For patients with SM,
the KIT D816V mutation leads to uncontrolled proliferation and activation of mast cells, resulting in chronic, severe and often
unpredictable symptoms across multiple organ systems. In addition, advanced SM is associated with organ damage due to mast
cell infiltration and poor survival.
Ayvakit was developed and is marketed by Blueprint Medicines, a Sanofi company. Globally, Ayvakit is approved for one or more
indications in more than 35 countries worldwide, including China where it has been developed and commercialized by CStone
Pharmaceuticals.
Neurology
Aubagio
Aubagio (teriflunomide) is used to help manage multiple sclerosis (MS). This small molecule agent, taken once daily, works by
reducing inflammation and modulating the immune system to prevent the immune attacks that cause MS symptoms.
Aubagio is approved in over 80 countries, including the US (since September 2012) for relapsing forms of MS; the EU (since
August 2013) for adult relapsing remitting MS; and China (since July 2018). In June 2021, the EC approved Aubagio for the
treatment of pediatric patients aged 10 to 17 years with relapsing-remitting multiple sclerosis (RRMS).
In 2017, Sanofi reached settlement with all 20 generic Aubagio ANDA first filers, granting royalty-free licenses to enter the US
market on March 12, 2023. In the EU, the first generic competitors to Aubagio became available in September 2023.
Oncology
Sarclisa
Sarclisa (isatuximab) is a differentiated anti-CD38 monoclonal antibody that targets a specific epitope on CD38, exerting
antitumor effects through multiple mechanisms of action. It is approved in nearly 60 countries for four indications in both newly
diagnosed (NDMM) and relapsed refractory multiple myeloma (RRMM).
Sarclisa was first approved in the US in March 2020 in combination with pomalidomide and dexamethasone for the treatment of
adults with RRMM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. In Europe,
the EC granted approval in May 2020 for Sarclisa in combination with pomalidomide and dexamethasone for the treatment of
adult patients with RRMM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and
have demonstrated disease progression on the last therapy. In early 2025, Sarclisa in combination with pomalidomide and
dexamethasone was approved by the NMPA in China for the treatment of adult patients with MM who have received at least one
prior line including lenalidomide and proteasome inhibitor, representing the first indication of Sarclisa approved in China.
In March 2021, Sarclisa received approval in the US for a label extension in combination with carfilzomib and dexamethasone for
the treatment of adults with RRMM who have received one to three prior lines of therapy. In Europe, the EC approved this
combination in April 2021 for the treatment of adult patients with MM who have received at least one prior therapy. The Japanese
MHLW granted approval for Sarclisa in November 2021 in combination with carfilzomib and dexamethasone, in combination with
dexamethasone, and as monotherapy for RRMM patients.
Sarclisa was approved in the US in September 2024, in Europe in January 2025, and as the second indication in China in January
2025 in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adults with NDMM who are not
eligible for autologous stem cell transplant (ASCT). In July 2025, Sarclisa received approval in Europe in combination with
bortezomib, lenalidomide, and dexamethasone (VRd) for the induction treatment of adult patients with NDMM who are eligible
for ASCT.
The Phase 3 IRAKLIA study investigating a new subcutaneous (SC) formulation with an on-body injector (OBI) was initiated in the
second half of 2022 in over 20 countries. The study has reported positive results, meeting its co-primary endpoints. This new
formulation is currently under regulatory review with agencies worldwide.
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Finally, Sarclisa is currently being investigated in multiple clinical studies, including trials in smoldering multiple myeloma, as a
stand-alone maintenance indication, and in combination with several innovative agents in MM through an umbrella Phase 1/2
study.
Jevtana
Jevtana (cabazitaxel), a chemotherapy drug and cytotoxic agent, is a semi-synthetic second-generation taxane that prevents
many cancer cells from dividing, which ultimately results in destroying many such cells. It is approved in combination with
prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a
docetaxel-containing treatment regimen. Jevtana was granted marketing authorization by the FDA in June 2010, by the EC in
March 2011, and in Japan in July 2014. The medicine is marketed in over 75 countries. In Europe, generic competition started for
Jevtana from the end of March 2021. In the US, the Jevtana composition of matter patent expired in September 2021. Sanofi
pursued patent litigation under the US Hatch-Waxman Act against generic manufacturers. Most cases were settled. Sanofi went
to trial against the remaining defendant, Sandoz, on one of the patents in January 2023; see Note D.22.b. to the consolidated
financial statements, included at Item 18. of this annual report. The district court issued a final judgment in favor of Sanofi; on
August 2, 2023, Sandoz appealed to the Court of Appeals for the Federal Circuit. On October 5, 2023, Sanofi and Sandoz filed a
joint stipulation voluntarily dismissing Sandoz’s Appeal, bringing this matter to conclusion.
Fasturtec/Elitek
Fasturtec/Elitek is used for the management of plasma uric levels in patients with leukemia, lymphoma, and solid tumor
malignancies receiving anticancer therapies.
Other medicines
Lantus
Lantus (insulin glargine 100 units/mL) is a long-acting analog of human insulin, indicated for once-daily administration for the
treatment of diabetes mellitus in adults, adolescents and children aged two years and above. Approved in the US and the EU in
2000 and in Japan in 2008, Lantus is available in over 130 countries. Two insulin glargine biosimilars are available in the US and
two in European markets.
Toujeo
Toujeo (insulin glargine 300 units/mL) is a long-acting analog of human insulin, indicated for the treatment of diabetes mellitus in
adults. Toujeo has been granted marketing authorization by the FDA (February 2015), the EC (April 2015), and the MHLW in
Japan, where its approved brand name is Lantus XR (July 2015). Toujeo has been launched in over 60 countries, including China
since 2020. In January 2020, the EC approved an expansion of the indication to include the treatment of diabetes in adolescents
and children (aged six years and above).
Toujeo is available in Toujeo Solostar, a disposable prefilled pen which contains 450 units of insulin glargine and requires
one-third of the injection volume to deliver the same number of insulin units as Lantus Solostar. In the US (since 2018) and the EU
(since 2019), Toujeo is also available in a disposable prefilled pen which contains 900 units of insulin glargine. In India, Toujeo is
also available in a dedicated 450-unit cartridge in combination with a dedicated reusable pen (TouStar).
Lovenox/Clexane
Lovenox or Clexane (enoxaparin sodium) is a low molecular weight heparin (LMWH) indicated for the prophylaxis and treatment
of venous thromboembolism and for acute coronary syndrome. In the US, enoxaparin generics are available, while biosimilar
enoxaparin medicines have gradually become available across various countries in Europe and the Rest of the World region,
including China. Lovenox or Clexane is marketed in over 100 countries.
Plavix/Iscover
Plavix or Iscover (clopidogrel bisulfate) is a platelet adenosine diphosphate (ADP) receptor antagonist, indicated for preventing
atherothrombotic events in patients with a history of recent myocardial infarction (MI), recent ischemic stroke or established
peripheral arterial disease (PAD), and for patients with acute coronary syndrome (ACS). Plavix is also indicated in combination
with acetylsalicylic acid (ASA) for the prevention of atherothrombotic and thromboembolic events in atrial fibrillation, including
stroke.
CoPlavix/DuoPlavin, a fixed-dose combination of clopidogrel bisulfate and ASA, is indicated for the prevention of
atherothrombotic events in adult patients with acute coronary syndrome who are already taking both clopidogrel and ASA.
Several clopidogrel bisulfate generics have been launched in most markets. Plavix or Iscover are available in over 110 countries.
Sanofi is involved in two Plavix medicine lawsuits. See Note D.22.c. to our consolidated financial statements, included at Item 18.
of this annual report.
Rezurock
Rezurock (belumosudil) is a first-in-class selective ROCK2 (rho-associated coiled-coil–containing protein kinase-2) inhibitor. It was
approved in July 2021 by the FDA for the treatment of adult and pediatric patients aged 12 years and older with chronic
graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy. In addition to robust adoption in the
US, Rezurock has been approved by health authorities in 20 countries. It is marketed in Japan, South Korea and Thailand by
partner Romeck Pharma. Early Access or Managed Access Programs are available in 28 countries. Rezurock has become the
standard of care treatment for chronic GVHD in the indicated setting across launched markets, further exemplified by significant
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uptake in China where over 8,600 patients have been prescribed Rezurock since the NRDL listing in January 2025. On
January 30, 2025, Sanofi received a positive opinion from the European Medicines Agency's Committee for Medicinal Products
for Human Use (CHMP) on conditional marketing authorization, following a re-examination of Rezurock for the treatment of
chronic GVHD in late line therapy. This represents a significant milestone in addressing the high unmet medical needs of EU
patients living with chronic GVHD. Sanofi is currently developing an oral suspension to support pediatric studies. The pivotal Phase
3 study (ROCKaspire) for Rezurock is currently enrolling patients for the treatment of chronic lung allograft dysfunction (CLAD)
post bilateral lung transplant. Sanofi has discontinued the ROCKnrol-1 Phase 3 study in newly diagnosed chronic GVHD patients
based on a pre-specified interim futility analysis.
Praluent
Praluent (alirocumab) is a human monoclonal antibody (mAb) for self-administered injection every two weeks or once-monthly. It
blocks the interaction of proprotein convertase subtilisin/kexin type 9 (PCSK9) with low-density lipoprotein (LDL) receptors,
increasing the recycling of LDL receptors and reducing LDL cholesterol levels. Praluent is indicated as an adjunct to diet and
maximally tolerated statin therapy in certain adult patients and in pediatric patients eight years of age and older with
heterozygous familial hypercholesterolaemia (HeFH) with uncontrolled LDL cholesterol. Praluent has been approved in more than
60 countries worldwide, including the US (in 2015) and the European Union (in 2015). In 2018, the FDA approved a Praluent label
update for patients currently requiring LDL apheresis therapy. In March 2019 in the EU and in April 2019 in the US, Praluent was
approved for use in adults with established cardiovascular disease to reduce the risk of cardiovascular events. In November 2023,
following a positive review by the EMA, the EC approved a Praluent label update for pediatric HeFh patients aged eight years and
older. In December 2019, Praluent was approved in China, where it started to be commercialized in May 2020. Since April 2020,
Regeneron has been responsible for commercialization of Praluent in the US, and Sanofi has been responsible for all other
markets outside the US. For additional information on the commercialization of this medicine, see “Item 5. Operating and
Financial Review and Prospects — A.1.7. Financial Presentation of Alliances — Alliance Arrangements with Regeneron
Pharmaceuticals, Inc. (Regeneron).”
Thymoglobulin
Thymoglobulin (anti-thymocyte globulin) is a polyclonal anti-human thymocyte antibody preparation that acts as a broad
immunosuppressive and immunomodulating agent. In the US, Thymoglobulin is indicated for the prophylaxis and/or treatment
of acute rejection in patients receiving a kidney transplant, used in conjunction with concomitant immunosuppression. Outside
the US, depending on the country, Thymoglobulin is indicated for the treatment and/or prevention of acute rejection in organ
transplantation; immunosuppressive therapy in aplastic anemia; and the treatment and/or prevention of Graft-versus-Host
Disease (GvHD) after allogeneic hematopoietic stem cell transplantation. Thymoglobulin is marketed in over 65 countries.
Aprovel/Avapro/Karvea
Aprovel, also known as Avapro or Karvea (irbesartan), is an angiotensin II receptor antagonist indicated for hypertension and for
renal disease in patients with hypertension and type 2 diabetes. Sanofi also markets CoAprovel/Avalide/Karvezide, a combination
of irbesartan and the diuretic hydrochlorothiazide. A combination with amlodipine (Aprovasc, Aprexevo, Aproxxamlo) has been
launched in several countries.
Irbesartan generics are available in most markets. Aprovel and CoAprovel are marketed in over 80 countries. In Japan, the
medicine is licensed to Shionogi Co. Ltd and BMS KK, which sublicensed to Dainippon Pharma Co. Ltd.
Multaq
Multaq (dronedarone) is an oral anti-arrhythmic multichannel blocker indicated for preventing atrial fibrillation recurrences in
patients with a history of paroxysmal or persistent atrial fibrillation. Multaq was approved in the US and in the EU in 2009.
Multaq is available in approximately 35 countries.
Soliqua – Suliqua
Soliqua 100/33 or Suliqua is a once-daily fixed-ratio combination of insulin glargine 100 Units/mL, a long-acting analog of human
insulin, and lixisenatide, a GLP-1 receptor agonist. The FDA approved Soliqua 100/33 in November 2016 for the treatment of
adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 units daily) or lixisenatide; and in February 2019
for patients uncontrolled on oral antidiabetic medicines. In January 2017, Suliqua (the medicine’s brand name in Europe) was
approved for use in combination with metformin with or without SGLT-2 inhibitors for the treatment of adults with type 2
diabetes to improve glycemic control, when this had not been provided either by metformin alone or by metformin combined
with another oral glucose-lowering medicine or with basal insulin. The EU label was updated in 2024 to include “with or without
SGLT2 inhibitors”. In Japan, Soliqua was approved in May 2020 for type 2 diabetes mellitus, where treatment with insulin is
required. In China, Soliqua was approved in January 2023 for the treatment of adults with insufficiently controlled type 2 diabetes
mellitus to improve glycemic control as an adjunct to diet and exercise in addition to other oral antidiabetic drugs. Soliqua
received NRDL status in China in December 2023. Soliqua is available in over 40 countries and approved in over 80 countries.
Mozobil
Mozobil (plerixafor injection) is a hematopoietic stem cell mobilizer. It is indicated in combination with granulocyte-colony
stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous
transplantation in patients with non-Hodgkin’s lymphoma (NHL) and MM. Mozobil is marketed in over 65 countries. Generic
Mozobil has been available in the US since the end of 2023, and in Europe since 2024.
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Tzield/Teizeild
Tzield (teplizumab) is a CD3-directed antibody (CD3 is a cell surface antigen present on T lymphocytes). It was approved by the
FDA in November 2022 to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged eight years and
older with Stage 2 type 1 diabetes. It was approved in Israel, the United Arab Emirates, Saudi Arabia, Kuwait, the UK and Canada
during 2024 and 2025, and in January 2026 by the EC for the same indication under the brand name Teizeild. The medicine is
currently marketed in the US, Israel, the United Arab Emirates, Saudi Arabia, Kuwait, Canada and the UK. It is currently in
development for further indications, including treatment of patients already at Stage 3 (clinical onset) type 1 diabetes, as well as
pediatric patients aged zero to seven at Stages 2 and 3 type 1 diabetes. The FDA accepted for priority review the sBLA for Tzield
to expand the current age indication from eight years and above, to as young as one year old and above to delay the onset of
stage 3 T1D in patients diagnosed with stage 2 T1D. The sBLA is supported by the positive interim one-year data from the
ongoing PETITE-T1D phase 4 study, evaluating the safety and pharmacokinetics of Tzield in young children. Tzield is also under
review in the US to delay the progression of stage 3 T1D in adults and children eight years of age and older recently diagnosed
with stage 3 T1D. The FDA nominated Tzield for the Commissioner's National Priority Voucher pilot program based on its potential
to address a large unmet medical need. Early Access Programs and Managed Access Programs are available in several European
countries.
Vaccines
The Vaccines division of Sanofi is a world leader in the vaccine industry and a key supplier of life-saving vaccines all over the
world and for publicly funded international stakeholders such as UNICEF, the Pan American Health Organization (PAHO) and the
Global Alliance for Vaccines and Immunization (GAVI).
The Vaccines portfolio includes the following products:
Influenza vaccines
Sanofi is a world leader in the production and marketing of influenza vaccines, offering several distinct influenza vaccines that are
sold globally.
As influenza strains can vary from one season to the next, the World Health Organization (WHO) selects the strains to be included
in influenza vaccines for each season. For the 2024 season, the WHO recommended moving from quadrivalent influenza vaccines
including two A strains and two B strains back to trivalent influenza vaccines including two A strains and one B strain, as it was
considered that the B Yamagata strains were no longer circulating. Manufacturers have therefore progressively moved back from
quadrivalent to trivalent influenza vaccines. In 2025, Sanofi switched to trivalent in most geographies.
Fluzone High-Dose, designed specifically to provide greater protection against influenza for people aged 65 years and older, was
approved by the FDA in November 2019 in its quadrivalent formulation. The high-dose vaccine was also approved in the EU in the
second quarter of 2020, under the name Efluelda, indicated for adults aged 60 years and above. Both Fluzone High-Dose and
Efluelda have been available since the 2020/21 influenza season. To date, this vaccine has been distributed to more than
25 countries worldwide. Fluzone High-Dose/Efluelda (trivalent formulation) includes two A strains and only one B strain. In
October 2025, The Lancet published new data from the FLUNITY-HD study showing Fluzone High-Dose significantly reduced
the risk of hospitalization in adults aged 65 years and older compared to standard-dose influenza vaccines. FLUNITY-HD is the
largest influenza vaccine effectiveness study of individually randomized older adults, with nearly half a million participants across
three influenza seasons.
Flublok is a trivalent recombinant protein-based influenza vaccine licensed in the US, Hong Kong and Australia; this same
recombinant protein-based influenza vaccine is also licensed under the brand name Supemtek in the United Kingdom. Flublok is
indicated for individuals aged nine years and older in the US and for adults aged 18 and older in other countries.
Fluzone trivalent is an inactivated trivalent influenza vaccine (TIV), produced in the US, containing two type A antigens and one
type B antigen. Fluzone trivalent is available in five countries (including the US) for children aged over six months, adolescents
and adults.
Vaxigrip is a trivalent influenza vaccine, containing two antigens against type A influenza viruses and one antigen against type B
influenza viruses.
VaxigripTetra is the quadrivalent (QIV) version of Vaxigrip, including two antigens against A strains of influenza viruses and two
antigens against B strains, and is produced in France. Vaxigrip Tetra was licensed in 2016 and has been approved in more than
90 countries. Following the new WHO recommendations, countries have switched back to Vaxigrip (trivalent) for the coming
seasons.
COVID Vaccine
In 2025, Sanofi started to commercialize the recombinant adjuvanted COVID-19 vaccine Nuvaxovid, developed by Novavax.
Sanofi is now the market authorization holder for this vaccine in the US, the EU and the United Kingdom, leading the
commercialization of Nuvaxovid in the US for the 2025-26 season and expanding to other markets from the 2026-27 season and
beyond.
SANOFI FORM 20-F 2025 | 33 |
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ITEM 4. Information on the Company |
Poliomyelitis, pertussis and hemophilus influenzae type b (Hib) pediatric vaccines
Sanofi is one of the key players in pediatric vaccines in both developed and emerging markets, with a broad portfolio of
standalone and combination vaccines protecting against up to six diseases in a single injection. Due to the diversity of
immunization schedules throughout the world, vaccines can be either quadrivalent, pentavalent, or hexavalent according to
regional specificities.
Tetraxim, a pediatric combination vaccine protecting against diphtheria, tetanus, pertussis and poliomyelitis (polio), was first
marketed in 1998. To date, the vaccine has been launched in close to 100 countries (this vaccine is not marketed in the US).
Pentaxim, a pediatric combination vaccine protecting against diphtheria, tetanus, pertussis, polio and Hemophilus influenzae
type b (Hib), was first marketed in 1997. To date, the vaccine has been launched in more than 90 countries (this vaccine is not
marketed in the US). In most European, Latin American, Asian and Middle Eastern markets, Pentaxim is being gradually replaced
by Hexaxim.
Hexaxim/Hexyon/Hexacima is a fully liquid, ready-to-use 6-in-1 (hexavalent) pediatric combination vaccine that provides
protection against diphtheria, tetanus, pertussis, polio, Hib and hepatitis B. Hexaxim is the only combination vaccine including
acellular pertussis (acP) and inactivated polio vaccines (IPV) currently prequalified by the WHO. First marketed in 2013, Hexaxim is
now available in more than 100 countries outside the US.
Pentacel, a pediatric combination vaccine protecting against diphtheria, tetanus, pertussis, polio and Hemophilus influenzae
type b (Hib), was launched in the US in 2008.
Quadracel is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis and polio, used in children aged
four through six years as a fifth dose in the diphtheria, tetanus, pertussis vaccination (DTaP) series, and as a fourth or fifth dose in
the IPV series. It was launched in the US in 2017.
ACT-HIB is a standalone vaccine protecting against Hib, and is mainly distributed in the US in conjunction with pertussis
combination vaccines that do not contain the Hib valence.
Sanofi is a leading provider of polio vaccines and has been a partner of the Global Polio Eradication Initiative (GPEI) for over
30 years. Since Sanofi launched its first IPV, more than 1.5 billion doses have been distributed worldwide.
Booster vaccines
Adacel is the leading trivalent booster vaccine offering protection against diphtheria, tetanus and pertussis (Tdap). The vaccine
can be used from four years of age following primary immunization and is the first Tdap vaccine indicated for use during
pregnancy for protection against pertussis in newborns. It is available in approximately 70 countries including the US and other
countries, mostly in Europe, Asia and Latin America. Recently, Adacel has been introduced in additional countries that are
implementing new vaccination programs, particularly focusing on maternal immunization.
Repevax/Adacel-Polio is a combination vaccine that provides protection against diphtheria, tetanus, pertussis and polio. It is the
first Tdap-IPV vaccine indicated for use during pregnancy for protection against pertussis in newborns. It is currently marketed in
approximately 25 countries outside the US, with a strong focus on European markets (such as France and Germany).
Respiratory syncytial virus (RSV) protection
In 2023, Sanofi launched Beyfortus (nirsevimab-alip), a long-acting monoclonal antibody designed to protect all infants against
RSV. It is indicated for the protection of neonates and infants born during or entering their first RSV season, and for children up to
24 months who remain particularly vulnerable to severe RSV in their second RSV season.
Beyfortus is licensed in numerous countries and has now been launched in more than 45 countries, including in North America,
Europe, China and Japan. Real world data from countries such as the US, Spain and France have confirmed and even surpassed
the outstanding efficacy data generated during the clinical development of this monoclonal antibody. Many more countries are
expected to implement all-infant protection programs in the future. Sanofi and AstraZeneca plc (AstraZeneca) entered into an
agreement in 2017 to develop and commercialize Beyfortus, under which AstraZeneca leads development and manufacturing
activities and Sanofi leads commercialization activities and records revenues. Sanofi will continue to expand Beyfortus in new
geographies across Europe, Asia and Latin America.
34 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 4. Information on the Company |
Meningitis and travel & endemic vaccines
Menactra, the first quadrivalent conjugate vaccine against meningococcal meningitis (serogroups: A, C, Y, and W-135), one of the
deadliest forms of meningitis, is indicated for people aged nine months through 55 years. Since launch, it has become a strong
leader in the meningitis quadrivalent market. It is commercialized in a large number of countries (excluding Europe). Menactra was
the first fully liquid (no reconstitution needed) meningitis quadrivalent conjugated vaccine, and more than 150 million doses of
this vaccine have been distributed since launch.
MenQuadfi is a novel fully-liquid meningococcal quadrivalent conjugated vaccine expected to have a broad age indication from
infants (six weeks) to the elderly, with flexible dosing schedules. MenQuadfi has demonstrated consistent, long-lasting immune
responses across serogroups A, C, W and Y, with demonstrated superiority for serogroup C in toddlers versus comparators
(standard-of-care in multiple markets in Europe and internationally), while offering a favorable safety profile. Over time,
MenQuadfi will fully replace Menactra. The product is currently approved and available across multiple markets worldwide, with
over 23 million doses distributed since launch. In the US, regulatory approval extends to individuals aged six weeks and above,
following the FDA label extension granted in May 2025.
Sanofi provides a comprehensive portfolio of travel and endemic vaccines, including yellow fever, rabies, typhoid and hepatitis A
vaccines. These vaccines are used by diverse populations, from populations in endemic regions to travelers and military personnel
from non-endemic regions. Those vaccines are the foundation for important partnerships with governments and organizations
such as UNICEF. Sanofi is currently investing in next-generation rabies and yellow fever vaccines to address evolving public
health needs.
Vaxelis
Vaxelis is a hexavalent combination vaccine protecting against diphtheria, tetanus, pertussis, polio, Hib and hepatitis B. This
vaccine (developed and distributed in partnership with Merck & Co., Inc.) was approved in 2016 by the EC and is distributed in
various EU countries either by Sanofi or by MSD. Vaxelis was approved by the FDA in December 2018, becoming the first
hexavalent vaccine to be approved in the US, and launched in that country in June 2021.
Sales of Vaxelis in the US are recognized by the MSP Vaccine Company joint venture and credited equally to Merck & Co., Inc. and
Sanofi as income from equity affiliates. Consequently, these sales are not reported separately in each joint venture partner’s net
sales. Sanofi recognizes 50% of the joint venture's profits within the line item Share of profit/(loss) from investments
accounted for using the equity method.
SANOFI FORM 20-F 2025 | 35 |
PART I |
ITEM 4. Information on the Company |
B.3. Opella
In October 2024, in line with its strategy of focusing on innovative medicines and vaccines, Sanofi announced that it had entered
into exclusive negotiations for the sale of a controlling stake of around 50% in Opella to CD&R. Following those negotiations,
Sanofi sold a 50% controlling stake in Opella to CD&R through a share purchase agreement and a separation agreement, which
are described below.
•Share Purchase Agreement
In connection with the sale of a 50% controlling stake in Opella to CD&R (the Opella Transaction), on February 18, 2025, Sanofi
and Opal Bidco SAS (Bidco) entered into a share purchase agreement (the SPA). Sanofi and Bidco made certain customary
representations and warranties and agreed to certain customary covenants in connection with the SPA and the transaction
closed on April 30, 2025 (the Closing).
At Closing, Sanofi and CD&R (together with certain funds and affiliates) entered into a shareholders’ agreement (the
Shareholders’ Agreement) relating to the associate Opal JV Co S.à R.L. (JV Co), the joint venture holding company that indirectly
owns Opella following Closing. Sanofi retains a significant shareholding in Opella, through a 48.2% equity interest in JV Co.
Bpifrance Participations acquired an approximately 1.8% equity interest in JV Co. at Closing and is represented on Opella’s Board.
The Shareholders’ Agreement provides for a lock-up period of three years from Closing, during which Sanofi is only permitted to
carry out certain types of direct or indirect transfers of its securities in JV Co, and thereafter any transfer by Sanofi is subject to a
right of first offer in favor of CD&R, together with customary tag‑along and drag‑along rights.
•Separation Agreement
In connection with the separation of the Opella business, Sanofi entered into a Separation Agreement and certain other
agreements with Opella on July 22, 2024, to effect the separation of the Opella business and provide a framework for their
ongoing relationship. The Separation Agreement was amended on April 30, 2025.
The Separation Agreement sets out the rights and obligations of the parties with respect to the separation, including the terms
and conditions governing the transfer of assets to, and assumption of liabilities by, each of the Opella group and the Sanofi
group. In particular, Sanofi retained Gold Bond Co LLC and its business, and provided for the allocation of retained assets and
liabilities accordingly.
The Sanofi group and the Opella group each agreed, subject to certain exceptions, to release and indemnify the other party and
each of their respective past, present and future directors, officers, managers, agents and employees and each of the heirs,
executors, administrators, successors and assigns of any of the foregoing from any and all claims against any of them that arise
out of or relate to their respective businesses.
The Sanofi group agreed to indemnify the Opella group in respect of all liabilities relating to Sanofi’s retained businesses
(including environmental liabilities, whether arising before or after the Closing) and specified matters relating to Zantac branded
products prior to Closing, including product liability claims arising from commercialization, and personal injury claims resulting
from the manufacturing or handling of Zantac prior to Closing (see Note D.22.a. to our consolidated financial statements included
at Item 18. of this annual report).
B.4. Global research & development
Redefining immunology as we know it, our immuno-science approach is the bedrock of Sanofi’s research and development
(R&D). Combining our deep heritage and expertise in immunology, we are evaluating pathways of immunity and how they
function independent of specific diseases or pathologies.
Immuno-science is the connector of our R&D strategy, but it does not limit the depth and breadth of our pipeline. We continue to
pursue all areas of urgent unmet need and promising scientific discovery, where we are uniquely positioned to achieve innovation
for patients. This includes seeking out and engaging with external partners, ensuring we have access to the most innovative and
cutting-edge scientific developments in our search of first- or best-in-class medicines.
Our R&D pipeline is detailed in the section “— B.4.1. Biopharma pipeline” below.
Discovering and developing new medicines is a costly, lengthy, and uncertain process and our continuous investments in R&D for
future products and for the launches of newly registered medicines could result in increased costs without a proportionate
increase in revenues. See “Item 3. Key Information — D. Risk Factors” for further information.
36 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 4. Information on the Company |
B.4.1. Biopharma pipeline
For 2025, the main changes related to our medicines and vaccines pipeline were:
Medicines/Vaccines | Indication | Change | Reason |
elenestinib – D816V-mutated KIT inhibitor | indolent/smoldering systemic mastocytosis | Added | Acquired from Blueprint Medicines |
SAR449028 – Wild-type KIT inhibitor | chronic induced/spontaneous urticaria, allergic rhinoconjunctivitis | Added | Acquired from Blueprint Medicines |
SAR448501 – CD20 bispecific mAb | inflammatory indication | Added | Acquired from Dren Bio |
SAR448851 – TREM2 agonist | Alzheimer’s disease | Added | Acquired from Vigil Neuroscience |
SP0340 – subunit vaccine | respiratory syncytial virus + human metapneumovirus (older adults) | Added | Acquired from Vicebio |
SP0341 – subunit vaccine | respiratory syncytial virus + human metapneumovirus + parainfluenza virus type 3 (older adults) | Added | Acquired from Vicebio |
Redemplo – plozasiran - RNAi targeting APOC3 | familial chylomicronemia syndrome | Added | Co-developed with Arrowhead Pharmaceuticals(a) |
Myqorzo – aficamten - Cardiac myosin inhibitor | hypertrophic cardiomyopathy | Added | Co-developed with Corxel Pharmaceuticals(b) |
SAR402663 – sFLT01 AAV gene therapy | wet age-related macular degeneration | Added | Entered confirmatory development |
SAR446268 – DMPK AAV gene therapy | myotonic dystrophy type 1 | Added | Entered confirmatory development |
SAR446523 - GPRC5D mAb | relapsed/refractory multiple myeloma | Added | Entered confirmatory development |
SAR446597 – Bb×C1s AAV gene therapy | geographic atrophy in age-related macular degeneration | Added | Entered confirmatory development |
SAR448755 – STAT6 inhibitor | inflammatory indication | Added | Entered confirmatory development |
SP0269 – mRNA vaccine | chlamydia | Added | Entered confirmatory development |
eclitasertib - RIPK1 inhibitor | ulcerative colitis | Removed | Development discontinued |
SAR443579 – Trifunctional anti-CD123 NK-cell engager | acute myeloid leukemia | Removed | Development discontinued |
SAR444656 – IRAK4 degrader | atopic dermatitis, hidradenitis suppurativa | Removed | Development discontinued |
SAR444881 – ILT2 mAb | solid tumors | Removed | Development discontinued |
SAR445514 – Trifunctional anti-BCMA NK-cell engager | inflammatory indication | Removed | Development discontinued |
SAR446159 – Synuclein × IGF1R mAb | Parkinson’s disease | Removed | Development discontinued |
SAR447873 – SSTR targeting alpha-emitter therapy | gastroenteropancreatic neuroendocrine tumors | Removed | Development discontinued |
SP0125 – Live attenuated vaccine | respiratory syncytial virus (toddlers) | Removed | Development discontinued |
SP0237 – mRNA vaccine | influenza | Removed | Development discontinued |
(a)Sanofi has an exclusive license to develop and commercialize plozasiran in China, where this medicine was approved in January 2026.
(b)Sanofi has an exclusive license to develop and commercialize aficamten in China, where this medicine was approved in December 2025.
The portfolio of products in clinical development (from Phase 1 to Phase 3) and in registration as of December 31, 2025 is
described in “—E. R&D Appendix.”
Phase 1 studies are the first studies performed in humans, who are mainly healthy volunteers, except for studies in oncology
where Phase 1 studies are performed in patients. Their main objective is to assess the tolerability, the pharmacokinetic profile (the
way the product is distributed and metabolized in the body and how it is eliminated) and where possible the pharmacodynamic
profiles of the new drug (i.e. how the product may react on some receptors).
Phase 2 studies are early controlled studies in patients under closely monitored conditions to show efficacy and short-term
safety, and to determine the dose and regimen for Phase 3 studies.
Phase 3 studies have the primary objective of demonstrating or confirming the therapeutic benefit and safety of the new drug in
the intended indication and population. They are designed to provide an adequate basis for registration.
B.4.1.1. Products in development
Our R&D pipeline consists of innovative projects that are being developed to become first- or best-in-class medicines and
vaccines. These projects are evaluated across four main disease areas (immunology, rare diseases, neurology, and oncology) plus
vaccines, as detailed below.
a) Immunology
Sanofi delivered the first advanced biologic for atopic dermatitis with Regeneron, and this heritage in immunology is the
foundation for our immunoscience approach. Pursuing our ambition to be leader in immunology, we are exploring ways to restore
balance within the immune system, paving the way for treatments that address the root causes of a range of conditions,
including those that may not be commonly associated with an autoimmune or inflammatory response.
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ITEM 4. Information on the Company |
The main updates in respect of our immunology pipeline are detailed in the table below:
Project | Indication | Development phase | Pipeline updates in 2025 |
amlitelimab (OX40L mAb) | atopic dermatitis | Phase 3 | Positive Phase 3 study readouts (COAST 1 in 2025, and in COAST 2 and SHORE in January 2026) |
asthma | phase 2 | Phase 2 study readouts: primary endpoint not met; improvements across key secondary endpoints (TIDE) | |
hidradenitis suppurativa | Removed from Phase 2 | Negative outcome | |
celiac disease | Removed from Phase 2 | Indication deprioritized | |
alopecia areata | Removed from Phase 2 | Indication deprioritized | |
systemic sclerosis | Removed from Phase 2 | Indication deprioritized | |
lunsekimig (IL13×TSLP NANOBODY® VHH) | chronic obstructive pulmonary disease | Phase 3 | New indication in pipeline; studies ongoing (PERSEPHONE and THESUS) |
asthma | Phase 2 | Study ongoing (AIRCULES) | |
asthma, high-risk | Phase 2 | Study ongoing (AIRLYMPUS) | |
chronic rhinosinusitis with nasal polyps | Phase 2 | Study ongoing | |
atopic dermatitis | Phase 2 | New indication in pipeline; study ongoing | |
brivekimig (TNFa×OX40L NANOBODY® VHH) | hidradenitis suppurativa | Phase 2 | Phase 2a study readouts: primary endpoint met (HS-OBTAIN); Phase 2b study ongoing (BRIGHTEN) |
Crohn’s disease | Phase 2 | New indication in pipeline; study ongoing | |
ulcerative colitis | Phase 2 | New indication in pipeline; study ongoing | |
type 1 diabetes, stage 3 | Phase 2 | New indication; study ongoing (T1D OBTAIN) | |
duvakitug (TL1A mAb) | ulcerative colitis | Phase 3 | New phase; studies ongoing (SUNSCAPE-1 and SUNSCAPE-2). Phase 2b study readouts: primary endpoint met (RELIEVE UCCD); durable efficacy demonstrated in long-term extension study (RELIEVE UCCD LTE; February 2026) |
Crohn’s disease | Phase 3 | New phase; studies ongoing (STARCAPE-1 and STARCAPE-2). Phase 2b study readouts: primary endpoint met (RELIEVE UCCD); durable efficacy demonstrated in long-term extension study (RELIEVE UCCD LTE; February 2026) | |
balinatunfib (oral TNFR1 signaling inhibitor) | rheumatoid arthritis | Removed from Phase 2 | Phase 2 study readouts: primary endpoint not met; future development strategy under evaluation |
Crohn’s disease | Phase 2 | Study ongoing | |
ulcerative colitis | Phase 2 | New indication in pipeline; study ongoing | |
psoriasis | Removed from Phase 2 | Phase 2 study readouts: primary endpoint not met (SPECIFIC-PSO); removed from pipeline | |
itepekimab (IL33 mAb) | chronic obstructive pulmonary disease | Phase 3 | Phase 3 study readouts - primary endpoint met (AERIFY-1); not met (AERIFY-2) |
chronic rhinosinusitis with nasal polyps | Phase 3 | New indication in pipeline; studies ongoing (CEREN 1 and CEREN 2) | |
bronchiectasis | Removed from Phase 2 | Indication deprioritized | |
chronic rhinosinusitis without nasal polyps | Phase 2 | New indication in pipeline; study ongoing | |
SAR449028 (wild-type KIT inhibitor) | chronic induced/spontaneous urticaria | Phase 2 | New project in pipeline; study ongoing |
allergic rhinoconjunctivitis | Phase 2 | New project in pipeline; study ongoing | |
SAR444336 (non-beta IL2 Synthorin) | microscopic colitis | Phase 2 | New phase; study ongoing |
frexalimab (CD40L mAb) | systemic lupus erythematosus | Removed from Phase 2 | Indication deprioritized |
type 1 diabetes | Phase 2 | Study ongoing | |
rilzabrutinib (BTK inhibitor) | asthma | Phase 2 | Phase 3 study to start in 2026 |
chronic spontaneous urticaria | Phase 2 | Phase 3 study to start in 2026 | |
riliprubart (C1s mAb) | antibody-mediated rejection | Phase 2 | Regulatory designation: US ODD |
SAR445399 (IL1R3 mAb) | hidradenitis suppurativa | Phase 2 | New phase; study ongoing (CLAROS) |
SAR446422 (CD28×OX40 bispecific Ab) | inflammatory indication | Phase 1 | Study ongoing |
SAR446959 (MMP13×ADAMTS5×CAP NANOBODY® VHH) | knee osteoarthritis | Phase 1 | Study ongoing |
SAR448501 (CD20 bispecific mAb) | inflammatory indication | Phase 1 | New project in pipeline; study ongoing |
SAR448755 (STAT6 inhibitor) | inflammatory indication | Phase 1 | New project in pipeline; study ongoing |
ODD: orphan drug designation; mAb: monoclonal antibody.
38 | SANOFI FORM 20-F 2025 |
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ITEM 4. Information on the Company |
b) Rare Diseases
We are advancing a robust pipeline in rare diseases, leveraging our deep understanding of the unique biological drivers that
underpin these conditions with high unmet needs. Through our integrated R&D approach, we are also harnessing our
immunoscience expertise to investigate novel molecules that could expand our pipeline into other rare diseases where significant
unmet need remains.
The main updates in respect of our rare diseases pipeline are detailed in the table below:
Project | Indication | Development phase | Pipeline updates in 2025 |
Qfitlia (fitusiran - RNAi targeting anti-thrombin) | hemophilia A or B | regulatory | Approved in the US and in China; Phase 3 study ongoing (Atlas NEO) to support EU and Japan regulatory submissions |
Redemplo (plozasiran - RNAi targeting APOC3) | familial chylomicronemia syndrome | regulatory | New project in pipeline; approved in China in January 2026 |
Wayrilz (rilzabrutinib - BTK inhibitor) | immune thrombocytopenia | regulatory | Approved in the US and EU; under regulatory review in Japan |
warm autoimmune hemolytic anemia | Phase 3 | New indication in pipeline; study ongoing (LUMINA 3); Regulatory designations: US ODD; US breakthrough therapy and orphan drug in Japan (in February 2026) | |
sickle cell disease | Phase 3 | New indication in pipeline; study ongoing (LIBRA); Regulatory designation: US ODD | |
Graves’ disease | Phase 2 | New indication in pipeline; study ongoing | |
IgG4-related disease | Phase 3 | New phase; study ongoing (RILIEF); Regulatory designations: US ODD, EU orphan designation; US FTD | |
elenestinib (D816V-mutated KIT inhibitor) | indolent/smoldering systemic mastocytosis | Phase 3 | New project in pipeline; study ongoing (HARBOR) |
venglustat (oral GCS inhibitor) | Fabry disease | Phase 3 | Phase 3 study readouts (PERIDOT): primary endpoint not met; reduction in neuropathic and abdominal pain observed. Study evaluating effect on left cardiac ventricular mass index ongoing (CARAT). |
Gaucher disease type 3 | Phase 3 | Phase 3 study readouts (LEAP2MONO) in February 2026: primary endpoints met. Sanofi will pursue global regulatory filings. | |
efdoralprin alfa (AAT fusion protein) | alpha-1 antitrypsin deficiency emphysema | Phase 2 | Phase 2 study readouts: primary endpoint met (ElevAATe); Regulatory designations: US ODD, EU orphan designation |
frexalimab, rilzabrutinib, brivekimig | focal segmental glomerulosclerosis/ minimal change disease | Phase 2 | New indication in pipeline; study ongoing (RESULT) |
SAR446268 (DMPK AAV gene therapy) | myotonic dystrophy type 1 | Phase 1 | New project in pipeline; study ongoing (BrAAVe) Regulatory designation: US ODD |
ODD: orphan drug designation; FTD: fast-track designation; AAV: adeno-associated virus.
c) Neurology
Sanofi is developing new medicines built on patient insights and leading-edge science to help the millions of people living with
neurological disorders. Using revolutionary technologies, Sanofi scientists are developing targeted, potentially disease-modifying
therapies for people living with conditions such as MS. The goal is to design best-in-class medicines that slow or halt
neurodegeneration, control neuroinflammation, and protect or even repair the nervous system.
The main updates in respect of our neurology pipeline are detailed in the table below:
Project | Indication | Development phase | Pipeline updates in 2025 |
tolebrutinib (BTK inhibitor) | secondary progressive multiple sclerosis (MS) | regulatory | Under regulatory review in the US and EU. Complete response letter issued by the FDA in December 2025; decision to go beyond the revised target action date of December 28, 2025. Regulatory designation: US priority review. |
primary progressive MS | Removed from Phase 3 | Study readouts - primary endpoint not met (PERSEUS) | |
frexalimab (CD40L mAb) | relapsing MS | Phase 3 | Study ongoing (FREXALT) |
non-relapsing secondary progressive MS | Phase 3 | Study ongoing (FREVIVA) | |
riliprubart (C1s mAb) | SOC-refractory CIDP | Phase 3 | Regulatory designation: JP ODD - Study ongoing |
IVIg-treated CIDP | Phase 3 | Regulatory designation: JP ODD - Study ongoing | |
SAR402663 (sFLT01 AAV gene therapy) | wet age-related macular degeneration | Phase 2 | Regulatory designation: US FTD - Study ongoing |
SAR448851 (TREM2 agonist) | Alzheimer’s disease | Phase 1 | New project in pipeline; study ongoing |
SAR446597 (Bb×C1s Ab AAV gene therapy) | geographic atrophy in dry age- related macular degeneration | Phase 1 | New project in pipeline; study ongoing Regulatory designation: US FTD |
ODD: orphan drug designation; FTD: fast-track designation; mAb: monoclonal antibody; AAV: adeno-associated virus; CIDP: Chronic inflammatory
demyelinating polyneuropathy
SANOFI FORM 20-F 2025 | 39 |
PART I |
ITEM 4. Information on the Company |
d) Oncology
Our oncology pipeline is focused on ways to boost the immune system to better detect and attack tumors, and on precision
drugs designed to either destroy cancer cells or activate immune cells locally.
The main updates in respect of our oncology pipeline are detailed in the table below:
Project | Indication | Development phase | Pipeline updates in 2025 |
SAR445877 (PD1×IL15 fusion protein) | solid tumors | Phase 2 | New phase; study ongoing |
SAR445953 (CEACAM5-Topo1 ADC) | colorectal cancer | Phase 1 | Study ongoing |
SAR446523 (GPRC5D mAb) | relapsed/refractory multiple myeloma | Phase 1 | New project in pipeline; study ongoing; Regulatory designation: US ODD |
ADC: antibody-drug conjugate; mAb: monoclonal antibody; ODD: orphan drug designation.
e) Vaccines
Our leadership in immunoscience drives transformative innovation across our vaccine portfolio. This expertise underpins our
cutting-edge vaccine R&D, enabling us to help tackle global health challenges with innovative solutions.
The main updates in respect of our vaccines pipeline are detailed in the table below:
Project | Indication | Development phase | Pipeline updates in 2025 |
SP0087 (vero cell vaccine) | rabies | Phase 3 | Phase 3 study readouts: positive safety and immunogenicity results. Under regulatory review in the EU. |
SP0202 (21-valent conjugate vaccine) | pneumococcal disease (children) | Phase 3 | Study ongoing |
SP0218 (vero cell vaccine) | yellow fever | Phase 3 | New phase; study ongoing |
SP0230 (5-valent ACWY+B vaccine) | meningitis | Phase 2 | Study ongoing |
SP0256 (mRNA vaccine) | RSV+hMPV (older adults) | Phase 2 | Phase 2b study readouts (RSV mRNA vaccine alone): high efficacy RSV mRNA vaccine alone on several endpoints. Phase 1/2 study readouts (RSV+hMPV mRNA vaccine): very competitive anti-hMPV antibody levels evidenced. |
SP0268 (mRNA vaccine) | acne | Phase 2 | New phase; study ongoing |
SP0289 (mRNA vaccine) | flu H5 pandemic | Phase 2 | Phase 1/2 study: good safety profile and strong immunogenicity results; New phase; phase 2 study ongoing |
SP0335 (inactivated adjuvanted vaccine) | flu H5 pandemic | Phase 2 | Sanofi received funding from the BARDA for early-stage clinical work on this vaccine candidate including Novavax’s Matrix-M adjuvant. |
SP0269 (mRNA vaccine) | chlamydia | Phase 1 | New project in pipeline; Phase 1/2 study ongoing; Regulatory designation: US FTD |
SP0287 (Fluzone HD + Nuvaxovid) | flu+COVID-19 | Phase 1 | Phase 1/2 study: preliminary positive safety and immunogenicity results |
SP0287 (Flublok + Nuvaxovid) | flu+COVID-19 | Phase 1 | Phase 1/2 study: preliminary positive safety and immunogenicity results |
SP0291 (mRNA vaccine) | RSV+hMPV+PIV3 (older adults) | Phase 1 | Study ongoing |
SP0340 (subunit vaccine) | RSV+hMPV (older adults) | Phase 1 | New project in pipeline; study ongoing |
SP0341 (subunit vaccine) | RSV+hMPV+PIV3 (older adults) | Phase 1 | New project in pipeline; study ongoing |
FTD: fast-track designation; BARDA: Biomedical Advanced Research and Development Authority; RSV: respiratory syncytial virus; hMPV: human
metapneumovirus; PIV3: parainfluenza virus type 3.
40 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 4. Information on the Company |
B.4.1.2. Line extensions
The main updates in R&D activities supporting line extensions for our marketed products are summarized below. For more
information on marketed products, see also “ — B.2. Biopharma segment.”
Marketed product | Line extension indication | Development phase | Pipeline updates in 2025 |
Dupixent (dupilumab – IL4R mAb) | chronic obstructive pulmonary disease | Regulatory | Approved in Japan |
chronic spontaneous urticaria | Regulatory | Approved in the US and the EU; Under regulatory review in the US, the EU and Japan (children) | |
bullous pemphigoid | Regulatory | Approved in the US after priority review; Under regulatory review in the EU, Japan and China | |
allergic fungal rhinosinusitis | Regulatory | Phase 3 study readouts: primary endpoint met (LIBERTY-AFRS-AI) Under regulatory priority review in the US | |
chronic pruritus of unknown origin | Phase 3 | Phase 3 study ongoing (LIBERTY-CPUO-CHIC) | |
lichen simplex chronicus | Phase 3 | Phase 3 studies ongoing (STYLE 1 and STYLE 2) | |
eosinophilic gastritis | Removed from Phase 3 | Indication deprioritized | |
ulcerative colitis | Removed from Phase 2 | Indication deprioritized | |
Tzield/Teizeild(a) (teplizumab – CD3 mAb) | type 1 diabetes, stage 2, delay of onset stage 3 | Regulatory | Approved in China and in the EU. Regulatory designation: US priority review for young children |
type 1 diabetes, stage 3, delay of progression | Regulatory | Under regulatory priority review in the US. Not recommended for EU approval by the CHMP; Sanofi has decided not to progress with the application at this time. Next steps are under evaluation. | |
Rezurock (belumosudil – ROCK2 inhibitor) | Chronic graft versus host disease, third line | Regulatory | CHMP positive recommendation obtained in January 2026, after Sanofi requested a re-examination of the prior negative opinion adopted in October 2025 |
chronic lung allograft dysfunction | Phase 3 | Phase 3 study ongoing (ROCKaspire) | |
chronic graft versus host disease, first line | Removed from Phase 3 | Phase 3 study discontinued based on pre-specified futility interim analysis (ROCKnrol-1) | |
Nexviazyme (avalglucosidase alfa – enzyme replacement therapy) | infantile-onset Pompe disease | Phase 3 | Study ongoing (Baby-COMET) |
Cerezyme (imiglucerase – enzyme replacement therapy) | Gaucher disease type 3 | Regulatory | Approved in the US (in January 2026) |
Sarclisa (isatuximab – CD38 mAb) | NDMM, TI | Regulatory | Approved in the EU, Japan and China |
NDMM, TE | Regulatory | Approved in the EU; Phase 3 studies ongoing (GMMG HD7 and IsKia) to support additional regulatory submissions | |
R/R MM, subcutaneous formulation | Regulatory | Phase 3 study readouts: primary endpoints met; Under regulatory review in the US, the EU, Japan and China | |
smoldering multiple myeloma | Phase 3 | Phase 3 study ongoing (ITHACA) | |
R/R MM in combination | Phase 2 | Study ongoing | |
Fluzone HD (multivalent inactivated vaccine) | flu (50+ years) | Phase 3 | Phase 3 study readouts: positive safety and immunogenicity results at interim analysis |
MenQuadfi (4–valent ACWY conjugate vaccine) | meningitis (six weeks+) | Regulatory | Approved in the US |
(a) Teplizumab is known as Tzield, except in the EU where it is known as Teizeild.
mAb: monoclonal antibody; CHMP: Committee for Medicinal Products for Human Use; NDMM: newly diagnosed multiple myeloma; TE: transplant-eligible;
TI: transplant-ineligible.
B.4.2. R&D Expenditures
Expenditures on research and development amounted to €7,842 million in 2025 (€7,394 million in 2024). Research and
development expenditures represented approximately 18.0% of our net sales in 2025, compared with 18.0% in 2024. R&D spend,
excluding the 2024 one-off Sobi reimbursement following the registration of ALTUVIIIO in Europe, increased 6.3% year over year,
driven by strategic prioritization of key therapeutic growth areas (in particular immunology, rare diseases, neurology and
vaccines) and wind-down costs for the discontinued E. coli sepsis vaccine candidate, as well as new acquisitions and in‑licensing
agreements completed in 2025. Oncology spend was selectively reduced to support portfolio rebalancing to immunology.
SANOFI FORM 20-F 2025 | 41 |
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ITEM 4. Information on the Company |
B.5. Markets
A breakdown of revenues by segment and by geographical region for 2025, 2024, and 2023 can be found at Notes D.34. and
D.35. to our consolidated financial statements, included at Item 18. of this annual report.
The following market shares and ranking information are based on consolidated national pharmaceutical sales data (excluding
vaccines), in constant euros, on a September 2025 Moving Annual Total (MAT) basis. The data are mainly from IQVIA MIDAS local
sales audits supplemented by various other country-specific sources including Knobloch (Mexico), GERS (France) and HMR
(Portugal).
B.5.1. Marketing and distribution
We have business operations in approximately 60 countries and our products are available in more than 160 countries.
A breakdown of our aggregate net sales by geographical region is presented in “Item 5. Operating and Financial Review and
Prospects — Results of Operations — Year Ended December 31, 2025 Compared with Year Ended December 31, 2024.” Sanofi is
the ninth largest pharmaceutical company globally by sales. Our main markets in terms of net sales are respectively:
•US: we rank twelfth with a market share of 2.2%;
•Europe: we are the sixth largest pharmaceutical company in France where our market share is 4.0%, and we rank sixth in
Germany with a 3.0% market share; and
•other countries: we are ranked twelfth in Japan with a market share of 2.4%, and seventh in China with a market share of 1.6%.
Although specific distribution patterns vary by country, we sell prescription drugs primarily to wholesale drug distributors,
independent and chain retail drug outlets, hospitals, clinics, managed-care organizations and government institutions. Some
products in Rare Diseases and Oncology may also be sold directly to physicians. Our drugs are ordinarily dispensed to patients by
pharmacies upon presentation of a doctor’s prescription. Our vaccines are sold and distributed through multiple channels
including physicians, pharmacies, hospitals, private companies and distributors in the private sector, and governmental entities
and non-governmental organizations in the public and international donor markets.
We use a range of channels from in-person to digital to disseminate information about and promote our products among
healthcare professionals, ensuring that the channels not only cover our latest therapeutic advances but also our established
prescription products, which satisfy patient needs in some therapy areas. In some countries, products are also marketed directly
to patients by way of television, radio, newspapers and magazines, and digital channels (such as the internet), in accordance with
local regulations. National education and prevention campaigns can be used to improve patients’ knowledge of their conditions.
We regularly exhibit at major medical congresses.
Our sales representatives, who work closely with healthcare professionals, use their expertise to promote and provide scientific
information on our drugs, and to inform healthcare professionals when necessary about alternative access to our drugs for their
patients. They represent our values on a day-to-day basis and are required to adhere to a code of conduct and to internal
policies on which they receive training.
Sanofi markets most of its products through its own own sales forces. Nevertheless, Sanofi has entered into and continues to
form alliances to promote/market or co-promote/co-market certain products in specific geographical areas. Our major alliances
are detailed at “Item 5. Operating and Financial Review and Prospects — A.1.7. Financial Presentation of Alliances.” See also
“Item 3. Key Information — D. Risk Factors — We rely on third parties for the discovery, manufacture and marketing of some of
our products.”
B.5.2. Competition
The pharmaceutical industry continues to experience significant changes in its competitive environment.
There are four primary types of competition in the prescription pharmaceutical market:
•competition among pharmaceutical companies to research and develop new patented products or address unmet medical
needs;
•competition among different patented pharmaceutical products for the same therapeutic indication, including competition
for market access, as is currently being observed in particular in the US (but also in other markets around the world). The
number of drugs excluded from leading pharmacy benefit managers’ formularies has increased dramatically over the past
11 years in the US commercial health insurance market, with a total of 1,357 unique medications having faced exclusion for at
least one year from one PBM, mostly in crowded therapeutic areas. For 2025, the three largest pharmacy benefit managers
(PBMs) – Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group) – have again each excluded
600 or more drugs from their standard formularies. Formulary exclusions and utilization management are tools used by payers
to manage prescription drug costs and leverage their negotiating power with manufacturers;
•competition among original and generic products or original biological products and biosimilars, at the end of regulatory
exclusivity or patent protection; and
•competition among generic or biosimilar products.
Generics manufacturers who have received all necessary regulatory approvals for a product may decide to launch a generic
version before the patent expiry date, even in cases where the owner of the original product has already commenced patent
infringement litigation against the generics manufacturer. Such launches are said to be “at risk” for the owner and the promoter
of the generic product because it may be required to pay damages to the owner of the original product in the context of patent
infringement litigation; however, such launches may also significantly impair the profitability of the pharmaceutical company
whose product is challenged.
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ITEM 4. Information on the Company |
Drug manufacturers also face intra-product competition through parallel trade, where legally permitted. This refers to the
practice whereby parallel traders or importers purchase drugs in one country and sell them in another country without the
authorization of the original drug manufacturer. This usually occurs in markets where price differences exist due to factors like
varying regulations, taxes or exchange rates. The parallel trader or importer will repackage or resize the original product with
leaflets in the local language and sell it through an alternative channel at a higher price. This situation is of particular relevance in
the EU single market, where such practices have been encouraged by the current regulatory framework. Some of the risks arising
from parallel trade include quality and safety concerns, breach of intellectual property rights and supply chain disruptions (see
“Item 3. Key Information — D. Risk Factors”).
The industry is also facing a proliferation of falsified and substandard medicines, a problem particularly widespread in low- and
middle-income countries. The WHO estimates that 10% of medicines in these regions are falsified, affecting all therapeutic areas
including vaccines. Worldwide, falsified products are an issue, due in part to an exponential rise in internet connectivity of those
engaged in the manufacture, distribution and supply of substandard and falsified medical products.
In Vaccines, there are two primary types of competition:
•competition for innovation in the development of new vaccines, including breakthrough technologies (such as mRNA vaccines
introduced against COVID-19) or address unmet medical needs; and
•competition among different patented (or non-patented) vaccine products marketed for the same therapeutic indication.
In contrast, generics and biosimilars do not directly affect vaccines, which rely on proprietary viral or bacterial strains.
Competition from parallel importers remains limited due to the specific requirements for vaccines, such as the cold chain and the
need for administration by healthcare professionals.
B.5.3. Regulatory framework
The pharmaceutical and health-related biotechnology sectors are highly regulated. Sanofi’s business is subject to varying
degrees of governmental regulation in the countries in which operations are conducted. National and supranational health
authorities, such as the FDA in the US, the EMA and the EC in the EU, and the PMDA and the MHLW in Japan, administer a vast
array of legal and regulatory requirements that dictate pre-approval testing (including testing in human subjects) and quality
standards to maximize the safety and efficacy of a new medical product. These authorities also regulate product labeling,
manufacturing, importation/exportation, safety reporting, marketing and supply chains, as well as mandatory post-approval
requirements and commitments.
Prior to commercializing a pharmaceutical or biological product, approval by relevant regulatory authorities is required, based
upon the authority’s review of submitted pre-approval testing results and pursuant to processes that may vary across
jurisdictions and product type. The submission of an application to a regulatory authority does not guarantee that a license or
approval to market will be granted. Furthermore, each regulatory authority may impose its own requirements during product
development or during the application review. It may refuse to grant approval or require additional data before granting approval,
even in circumstances in which the same product has already been approved in other countries. Regulatory authorities also have
the authority to request product recalls and product withdrawals, to impose penalties for violations of regulations, and ultimately
the ability to revoke product licensure or approval.
Product review and approval can vary from six months or less to several years from the date of application submission, depending
upon the country and regulatory jurisdiction. Factors such as the quality of data and evidence, the review procedures, the nature
of the product, the condition to be treated, and any potential shifts in regulatory priorities, play a major role in the length of time
a product is under review, and whether or not the product is ultimately licensed or approved.
For a description of material risks relating to the regulatory environment in which we operate, refer to “Item 3.D. Risk Factors —
Risks relating to legal and regulatory matters.”
B.5.4. Pricing & reimbursement
We are operating in a new era of drug pricing and market access, driven by sweeping policy changes and shifting market
dynamics in 2026. We are facing heightened uncertainty in a changing world triggered by the US Presidential Administration's
most favored nation (MFN) policy and global price harmonization. See “Item 5. Operating and financial Review and Prospects —
A.1.1 2025 Overview — 2025 Business Developments.”
In this new era, governments and other payers will demand more value for money and superior evidence (e.g. comparative
efficacy studies, real-world patient data, budget modelling), raising the bar for market entry in many countries.
Looking ahead to 2026 and beyond, we anticipate that new policies in the US and EU will have a transformative impact on our
portfolio, on long-term pharma growth and the whole innovation ecosystem.
United States
Overview of the US health insurance system
Commercial insurance is offered widely as part of employee benefit packages and is the main source of employee access to
subsidized healthcare. Some individuals purchase private health plans directly or through marketplaces established under the
SANOFI FORM 20-F 2025 | 43 |
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ITEM 4. Information on the Company |
Affordable Care Act, while publicly subsidized programs provide coverage for retirees, the indigent, the disabled, uninsured
children, and active or retired military personnel. Double coverage can occur.
Commercial insurance includes:
•Managed Care Organizations (MCOs), which combine the functions of health insurance, delivery of care, and administration.
MCOs use specific provider networks and specific services and products. There are four primary types of managed care plans:
Health Maintenance Organizations (HMOs), Preferred Provider Organizations (PPOs), Exclusive Provider Organizations (EPOs),
and Point of Service (POS) plans; and
•PBMs, which serve as intermediaries between insurance companies, pharmacies and manufacturers to negotiate rebates and
discounts on formulary placement for commercial health plans, self-insured employer plans, Medicare Part D plans, and
federal and state government employee plans.
Government insurance includes:
•Medicare, which provides health insurance for retirees and for people with permanent disabilities. The basic Medicare scheme
(Part A) provides hospital insurance only, and the vast majority of retirees purchase additional cover through some or all of
three other plans named Part B, Part C and Part D. Part D enables Medicare beneficiaries to obtain outpatient drug coverage.
Almost two-thirds of all Medicare beneficiaries have enrolled in Part D plans;
•Medicaid, which provides health insurance for low-income families, certain qualified pregnant women and children, individuals
receiving supplemental security income, and other eligible persons determined on a state-by-state basis; and
•TRICARE, which provides health insurance for uniformed service members, retirees, and their families including
comprehensive healthcare, prescription and dental coverage.
The US remains the world’s largest pharmaceutical market, projected to reach $1.2 trillion by 2029. It continues to serve as the
primary innovation hub with strong access to new therapies.
However, 2026 marks a pivotal shift with two major federal policies reshaping the drug pricing landscape. The Inflation
Reduction Act (IRA) introduces negotiated prices for high-cost Medicare drugs, while the MFN voluntary agreements, signed with
the US Administration, provide tariff exemptions in return for substantial discounts on select medicines, including those for
Medicaid, Medicare, the direct-to-consumer market and future launches.
In May 2025, the US administration issued the MFN pricing executive order, which aims to align US drug prices with the lowest
prices paid in a basket of comparable OECD nations. On December 19, 2025, we signed a voluntary MFN agreement with the US
government. Under this agreement, we committed to align Medicaid prices on certain wholly owned medicines with other high
income countries; cut prices by 61% for select diabetes, cardiovascular, neurological, and cancer drugs; offer around 70%
discounts via the TrumpRx DTC platform (e.g. Plavix from $756 to $16); and expand the $35 monthly insulin cap to all US patients
effective January 1, 2026. The new pricing agreement is expected to accelerate the commoditization of our insulins and mature
US portfolio. The Centers for Medicare & Medicaid Services (CMS) have also introduced two new mandatory five-year drug
pricing models: the Global Benchmark for Efficient Drug Pricing (GLOBE) Model for Medicare Part B launching on October 1,
2026, and the Guarding US Medicare Against Rising Drug Costs (GUARD) Model for Medicare Part D launching on January 1,
2027. Both models will apply an MFN international reference pricing approach to selected Medicare covered medicines, aiming to
align US prices more closely with international benchmarks. If implemented, these mandatory drug pricing models could have a
material adverse effect on our business.
The IRA, signed into law in August 2022, will continue to exert unprecedented price pressure that will compress margins and
shorten product lifecycles (eight years for small molecules and 12 years for biologics). Some of the key provisions of the law relate
to Medicare price negotiations, inflation penalties on price increases, and Medicare Part D redesign, all phased in between 2022
and 2026. The most impactful change relates to Medicare drug price negotiations, starting with ten Part D drugs in 2026,
expanding to 15 drugs in 2027–2028, and 20 drugs annually from 2029 onward, including Part B. Negotiated rebates average
approximatively 62%, creating significant revenue pressure. The first negotiated prices took effect on January 1, 2026, with the
negotiated prices of the next 15 drugs expected to be announced by February 2026. The IRA is projected to cut federal drug
spending by $290 billion over the next decade, according to estimates from the Congressional Budget Office (CBO), signaling
significant headwinds for industry revenue growth and innovation.
In addition, in commercial channels, we continue to face intensifying pricing pressure and gross-to-net (GTN) erosion from
payers and pharmacy benefit managers (PBMs), resulting in tighter utilization management and a dramatic increase of formulary
exclusions, tighter utilization management, higher rebate demands, and accumulator/maximizer programs.
Moreover, rapidly shifting federal vaccine policies drive uncertainty, primarily triggered by recent changes to the Advisory on
Immunization Practices (ACIP) membership and scepticism toward existing immunization frameworks. These policy changes may
have long-term market implications and affect future pandemic preparedness.
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ITEM 4. Information on the Company |
Europe
In Europe, the pharmaceutical environment remains highly fragmented and challenging, shifting from traditional national
budget constraints to a complex framework shaped by the US MFN policy and sweeping EU‑level legislative reforms. The
combined impact of MFN pricing pressure and a potential new debt crisis in key European economies has shifted political
attention back to the pharmaceutical sector, renewing recognition of its role as a strategic engine of economic growth at both
national and European levels.
The US MFN policy is creating significant upward pricing pressures across Europe. Driven by efforts to rebalance global drug
prices, MFN pressures are pushing major EU countries to maintain higher prices for innovative medicines in order to avoid price
spillovers in the US and other markets. As a result, companies are exercising tighter control over EU launches and volumes,
prioritizing price integrity over speed of access.
At the same time, many European health systems that rely on clawbacks, paybacks, and mandatory rebates to contain
pharmaceutical spending are now revising their national policies to adapt to the evolving pricing landscape.These
mechanisms create high barriers to market entry for new products, with nearly half of innovative medicines remaining unavailable
to patients in 2024, according to the EFPIA's Patients W.A.I.T Indicator Survey. Recent reforms signal attempts to balance fiscal
cost-containment with competitiveness and innovation incentives, as exemplified by the UK-US landmark deal signed on
December 1, 2025, capping future UK clawback at around 15%, raising NICE's cost-effectiveness threshold to £25k-£35k per
QALY, and committing a budget increase for innovative drugs of 0.6% of GDP by 2035. However, significant delays persist across
Europe. France, for example, often requires 12 to 24 months for reimbursement decisions, while other markets experience similar
lengthy timelines. Germany stands out as the only major EU market providing immediate access.
Moreover, new EU-level regulations are reshaping the European pharmaceutical landscape. The EU Pharma Package, aimed
at modernizing the regulatory framework, preserves the eight-year baseline data protection, while introducing a more flexible,
conditional exclusivity model, including extensions for products that address unmet medical needs or meet certain innovation
criteria. Despite improvements to the initial Commission proposal, concerns remain about the expanding Bolar exemption
enabling earlier generic entry, and new access and supply obligations for manufacturers expected to apply from January 2027,
increasing regulatory and compliance burdens. The new legislation is anticipated to be adopted in the first quarter of 2026, with
implementation foreseen by mid-2028.
In parallel, the EU Health Technology Assessment (HTA) Regulation, in force since January 2025, mandates Joint Clinical
Assessments (JCAs) for oncology and advanced therapy medicinal products (ATMPs), with orphan drugs following in 2028
and all products, including vaccines, by 2030. The new mandatory JCAs tighten evidence requirements and significantly increase
the workload for industry. In 2025, 13 initial JCAs were completed, comprising 10 oncology therapies and 3 ATMPs. The first wave
of JCA reports, expected in 2026, will bring clarity on how the new process operates in practice and how joint assessments will be
used by national HTA bodies across Member States.
China
China is accelerating healthcare reforms under Healthy China 2030, focusing on managing the growing burden of chronic
diseases such as cancer, diabetes, and cardiovascular conditions while balancing access to innovation with cost containment.
Regulatory timelines have improved significantly, as illustrated by Dupixent gaining approval within six months through an
accelerated review process.
China is emerging as a global biopharma innovation hub, accounting for 30% of global clinical trial starts in 2024 according to
IQVA's Global Trends in R&D 2025 report. In 2023, 30 medicines discovered in China were approved, representing 37% of all new
drugs. The biotech sector is growing at a rate of 70% annually, and one in four innovative drug discoveries now originates in
China. Western pharmaceutical companies increasingly license early-stage assets from Chinese innovators, signaling a shift in
global innovation geography.
Overall, the landscape is becoming more predictable with rapid innovation and evolving funding models, albeit with steep price
cuts and intensifying local competition.
Pricing pressure remains intense, driven by NRDL negotiations and Volume-Based Procurement (VBP) tenders, where the
lowest price prevails. Access to innovative therapies has expanded rapidly, supported by annual NRDL updates. Effective January
1, 2026, the new NRDL list added 114 new drugs, of which 50 are Class I innovative drugs (i.e. China as the first global launch
country), and removed 29 drugs, signaling stricter evidence standards. VBP is expected to expand to multi-source biologics in
2026, building on VBP insulin pilots. Since its launch in 2018, VBP has become a key policy tool to control drug costs, with a
cumulative 490 drugs included through 11 rounds, and average price cuts ranging from 48% to 70%.
At the same time, funding models are evolving through a dual-track system that separates basic coverage under NRDL from
premium-priced therapies supported by commercial health insurance (CHI). The new Commercial Health Insurance Innovative
Drug List (CHIIDL), also effective January 2026, enables access to 19 high-cost, innovative drugs that address rare and unmet
needs, with lower price cuts (15%–50%) compared to NRDL’s average 60%. The new commercial list is expected to grow the role
of CHI in China, projected to increase from less than 8% today to nearly 30% coverage by 2035, creating substantial
opportunities for innovative medicines.
Pricing and reimbursement pressures are being felt in other regions and countries around the globe.
To overcome these challenges, we are developing tailored market access strategies early in the drug development process,
engaging in dialogue with payers and multiple stakeholders throughout the lifecycle, based on a thorough understanding of
evolving market dynamics.
SANOFI FORM 20-F 2025 | 45 |
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ITEM 4. Information on the Company |
B.6. Patents, intellectual property and other rights
Intellectual property rights are essential to our business because they protect our innovations and investments in research and
development, manufacturing and marketing of our products. Intellectual property rights include patents, trademarks, copyrights,
know‑how, trade secrets and regulatory-based protection.
Patent protection
We own a broad portfolio of patents, patent applications and patent licenses worldwide. These patents are of various types and
may cover: active ingredients; pharmaceutical formulations; product manufacturing processes; intermediate chemical
compounds; therapeutic indications/methods of use; technology platforms; delivery systems; digital applications; and enabling
technologies, such as assays. Patent protection is considered, in the aggregate, to be of material importance to the marketing
and sales of our products.
Patent protection for individual products typically extends for 20 years from the patent filing date in countries where we seek
patent protection. A substantial part of the 20-year life span of a patent on a new molecule (small molecule or biologic) has
generally already passed by the time the related product obtains marketing authorization. As a result, the effective period of
patent protection for an approved product’s active ingredient is significantly shorter than 20 years. In some cases, the period of
effective protection may be extended by procedures established to compensate regulatory delay in Europe (via Supplementary
Protection Certificate or SPC), in the US (via Patent Term Extension or PTE), in Japan (PTE), and in China (PTE).
The protection a patent provides to the related product depends upon the type of patent and its scope of coverage, and may
also vary from country to country.
We monitor our competitors and vigorously seek to challenge patent infringers when such infringement would negatively impact
our business objectives. See note D.22.b. to the consolidated financial statements included at Item 18. of this annual report.
The expiration or loss of a patent covering a new molecule, typically referred to as a compound patent, may result in significant
competition from generic or biosimilar products and can result in a dramatic reduction in sales of the original branded product
(see “Item 3. Key Information — D. Risk Factors”). In some cases, it is possible to continue to benefit from a commercial
advantage through product manufacturing trade secrets or other types of patents. Certain categories of products, such as
traditional vaccines and insulin, were historically relatively less reliant on patent protection and may in many cases have no patent
coverage. It is increasingly frequent for novel vaccines also to be patent protected.
Regulatory exclusivity
In some markets, including the EU and the US, many of our pharmaceutical products may also benefit from multi-year regulatory
exclusivity periods, during which a generic or biosimilar competitor may not rely on our clinical study and safety data in its drug
application. This exclusivity operates independently of patent protection and may protect the product from generic or biosimilar
competition even if there is no patent covering the product.
United States
•The FDA may not grant final marketing authorization to a generic competitor for a New Chemical Entity (NCE) until the
expiration of the regulatory exclusivity period (five years) that commences upon the first marketing authorization of the
reference listed drug.
•Significant new uses of existing NCEs, including new indications, may qualify for an additional three years of regulatory
exclusivity if certain conditions are met.
•For biological drugs, the FDA may not approve a biosimilar application until 12 years after the date on which the reference
product was first licensed.
•Pediatric extensions are available under certain conditions of the Hatch-Waxman Act by providing data on pediatric studies.
Under such cases the FDA allows for an extension of regulatory exclusivity and patent life by six months, to the extent these
protections have not already expired (the so-called “pediatric exclusivity”).
•Orphan drug exclusivity may be under certain circumstances to drugs intended to treat rare diseases or conditions.
European Union
•Regulatory exclusivity is available in two forms: data exclusivity and marketing exclusivity.
•Generic or biosimilar drug applications will not be accepted for review until eight years after the first marketing authorization
(data exclusivity). This eight-year period is followed by a two-year period during which generics or biosimilars cannot be
marketed (marketing exclusivity).
•The marketing exclusivity period can be extended to three years if, during the first eight-year period, the marketing
authorization holder obtains an authorization for one or more new therapeutic indications which are deemed to provide a
significant clinical benefit over existing therapies. This is known as the “8+2+1” rule.
•Pediatric extensions - A regulation on pediatric medicines provides for pediatric research obligations with potential associated
rewards including extension of supplementary patent protection and six-month regulatory exclusivity for pediatric marketing
authorization (for off-patent medicinal products).
•Orphan drug exclusivities also exist in the EU.
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ITEM 4. Information on the Company |
Japan
•The regulatory exclusivity period varies, but is generally four to six years for drugs for a specific use, and for medicinal products
with new indications or with new dosages; eight years for drugs containing a new chemical entity; ten years for orphan drugs,
and for new drugs requiring pharmaco-epidemiological study; six to eight years for innovative drugs (“SAKIGAKE” products),
and for orphan drugs with a new ethical combination or new mode of administration; and six years for other medicinal
products, such as new prescription combination drugs or drugs requiring a new mode of administration.
•There is no pediatric research extension of patent protection for patented medicinal products. However, regulatory exclusivity
may be extended from eight to ten years.
Emerging markets
One of the main limitations on our operations in emerging market countries is the lack of effective intellectual property protection
or enforcement for our products, which frequently do not provide non-patent exclusivity for innovative products. While the
situation has gradually improved, the lack of protection for intellectual property rights or the lack of robust enforcement poses
difficulties in certain countries. Additionally, in recent years a number of countries have waived or threatened to waive intellectual
property protection for specific products, for example through compulsory licensing of generics. See “Item 3. Key Information —
D. Risk Factors — Risks Relating to Sanofi’s Structure and Strategy — The globalization of our business exposes us to increased
risks in specific areas.”
Product and patent overview
We summarize in the table below the intellectual property coverage (in some cases through licenses) of our most significant
marketed products in terms of sales, in our major markets. In the discussion of patents below, we focus on active ingredient
patents (compound patents) and, in the case of NCEs, on any later filed patents listed as applicable in the FDA’s list of Approved
Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) or in its foreign equivalents. For biologics, the
Orange Book listing does not apply.
The table provides a list of expiration dates, which include six-month pediatric extensions when applicable, and when indicated,
extensions due to Patent Term Adjustment (PTA) or other regulatory delays. Where patent terms have expired we indicate such
information and mention whether generics or biosimilars are on the market.
References below to patent protection in Europe indicate the existence of relevant patents in most major markets in the EU.
Specific situations may vary by country.
We additionally set out any regulatory exclusivity from which these products continue to benefit in the EU, US or Japan.
Regulatory exclusivities presented below incorporate any pediatric extensions obtained. While EU regulatory exclusivity is
intended to be applied throughout the EU, in some cases Member States have taken positions prejudicial to our exclusivity rights.
For regulatory exclusivity in the US, only NCE or BLA are provided. In the EU, the regulatory exclusivity based on the first MA is
given.
United States | European Union | Japan | |
Dupixent | Compound: March 2031 with PTE* | Compound: September 2032 with SPC* (March 2033 with pediatric extension of SPC* in process of being granted across EU countries) | Compound: May 2034 with PTE* |
Later filed patents: coverage ranging through April 2045 (pending) | Later filed patents: coverage ranging through December 2043 (pending) | Later filed patents: coverage ranging through August 2043 (pending) | |
Regulatory exclusivity: March 2029 | Regulatory exclusivity: September 2028 | Regulatory exclusivity: January 2026 | |
Toujeo | Compound: expired | Compound: expired | Compound: expired |
Later filed patents: coverage ranging through May 2031 | Later filed patents: coverage ranging through May 2031 | Later filed patents: coverage ranging through July 2033 with PTE* | |
Lantus | Compound: expired | Compound: expired | Compound: expired |
Generics/biosimilars on the market | Generics/biosimilars on the market | Generics/biosimilars on the market | |
Lovenox | Compound: expired | Compound: expired | Compound: expired |
Generics on the market | Biosimilars on the market | ||
Plavix | Compound: expired | Compound: expired | Compound: expired |
Generics on the market | Generics on the market | Generics on the market | |
Fabrazyme | Patent: expired | Patent: expired | Patent: expired |
Generics/biosimilars on the market | |||
Myozyme | Compound: expired | Compound: expired | Compound: expired |
Alprolix | Use: December 2027 with PTE* | Compound: May 2029 with SPC* | Compound: February 2026 with PTE* |
Later filed patents: coverage ranging through April 2039 (pending) | Later filed patents: coverage ranging through December 2037 (pending) | Later filed patents: coverage ranging through December 2037 (pending) | |
Regulatory exclusivity: March 2026 | Regulatory exclusivity: May 2028 | ||
Cerezyme | Patent: expired | Patent: expired | Patent: expired |
SANOFI FORM 20-F 2025 | 47 |
PART I |
ITEM 4. Information on the Company |
United States | European Union | Japan | |
Praluent | Compound: December 2029 | Compound: December 2029 (SPC* in process of being granted across EU countries) | Compound: December 2034 with PTE* |
Later filed patent: coverage ranging through December 2036 | Later filed patent: coverage ranging through July 2035 | Later filed patent: coverage ranging through July 2035 | |
Regulatory exclusivity: July 2027 | |||
NEW LAUNCHES | |||
Beyfortus | Compound: January 2035 (PTE* pending) | Compound: January 2035 (SPC* in process of being granted across EU countries) | Compound: January 2035 (PTE* pending) |
Later filed patent: coverage ranging through September 2042 (pending) | Later filed patent: coverage ranging through September 2042 (pending) | Later filed patent: coverage ranging through September 2042 (pending) | |
Regulatory exclusivity: July 2035 | Regulatory exclusivity: November 2032 | Regulatory exclusivity: March 2032 | |
Nexviazyme/ Nexviadyme | Compound: March 2030 with PTA* (PTE* pending) | Compound: January 2028 (SPC* in process of being granted across EU countries) | Compound: December 2032 with PTE* |
Later filed patents: coverage ranging through May 2032 | Later filed patents: coverage ranging through May 2032 | Later filed patents: coverage ranging through December 2029 | |
Regulatory exclusivity: pending | Regulatory exclusivity: September 2031 | ||
Sarclisa | Compound: October 2032 with PTA* and PTE* | Compound: October 2032 with SPC* | Compound: October 2032 with PTE* |
Later filed patents: coverage ranging through November 2041 (pending) | Later filed patents: coverage ranging through November 2041 (pending) | Later filed patents: coverage ranging through November 2041 (pending) | |
Regulatory exclusivity: March 2032 | Regulatory exclusivity: May 2030 | Regulatory exclusivity: June 2028 | |
ALTUVIIIO | Compound: February 2037 with PTA* (PTE* pending) | Compound: January 2035 (SPC* in process of being granted across EU countries) | Compound: March 2037 with PTE* |
Later filed patents: coverage ranging through March 2043 (pending) | Later filed patents: coverage ranging through March 2043 (pending) | Later filed patents: coverage ranging through March 2043 (pending) | |
Regulatory exclusivity: February 2035 | Regulatory exclusivity: June 2034 | Regulatory exclusivity: September 2031 | |
Rezurock | Compound : June 2034 with PTA* and PTE* | N/A | Compound : March 2031 with PTE* |
Later filed patents : coverage ranging through July 2042 | Later filed patents : August 2037 and October 2038 (PTEs* granted) | ||
Regulatory exclusivity: July 2028 | Regulatory exclusivity: March 2034 | ||
Cablivi | Compound: February 2032 with PTA* and PTE* | Compound: May 2031 with SPC* | Compound: May 2031 with PTE* |
Later filed patents: coverage ranging through 2039 | Later filed patents: coverage ranging through 2039 (pending) | Later filed patents: coverage ranging through 2039 (pending) | |
Regulatory exclusivity: Feb. 2031 | Regulatory exclusivity: Sep. 2030 | Regulatory exclusivity: Sep. 2032 | |
Xenpozyme | Use: March 2036 with PTA* and PTE* | Use: August 2030 (SPC* in process of being granted across EU countries) | Use: August 2030 (PTE* pending) |
Later filed patents: coverage ranging through 2043 (pending) | Later filed patents: coverage ranging through 2043 (pending) | Later filed patents: coverage ranging through 2043 (pending) | |
Regulatory exclusivity: August 2034 | Regulatory exclusivity: June 2032 | Regulatory exclusivity: March 2030 | |
Tzield / Teizeld | Compound : Expired | Compound : Expired | N/A |
Later filed patents : coverage ranging through May 2043 (pending) | Later filed patents : coverage ranging through May 2043 (pending) | ||
Regulatory exclusivity: November 2034 | Regulatory Exclusivity: January 2036 | ||
Ayvakit | Compound: Oct 2034 | Compound: Sep 2035 with SPC | |
Later filed patents: coverage ranging through Feb 2045 (pending PCT) | Later filed patents: coverage ranging through Feb 2045 (pending PCT) | N/A | |
Regulatory exclusivity: Jun 2025 | Regulatory exclusivity: Sep 2030 | ||
Qfitlia | Compound: March 2033 (PTE* pending) | N/A | N/A |
Later filed patents: coverage ranging through March 2046 (pending) | |||
Regulatory exclusivity: March 2030 | |||
Wayrilz | Compound: Sept 2033 (PTE* pending) | Compound: Sept 2033 | N/A |
Later filed patents: coverage ranging through 2044 (pending) | Later filed patents: coverage ranging through 2044 (pending) | ||
Regulatory exclusivity NCE: Aug 2030 | Regulatory exclusivity NCE: Dec 2035 | ||
* PTE: Patent Term Extension; – SPC: Supplementary Protection Certificate; – PTA: Patent Term Adjustment; - PCT Patent Cooperation Treaty; - NCE :
New Chemical Entity
48 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 4. Information on the Company |
Third-party patents and challenges to intellectual property
Patents held or licensed by Sanofi do not in all cases provide effective protection against a competitor’s generic or biosimilar
version of our products. For example, notwithstanding the presence of unexpired patents, competitors launched generic versions
of Allegra in the US (prior to the product being switched to over-the-counter status) and Multaq in the EU.
We caution the reader that there can be no assurance that we will prevail when we assert a patent in litigation and that there may be
instances in which Sanofi determines that it does not have a sufficient basis to assert one or more of the patents mentioned in this
report, for example in cases where a competitor proposes a formulation not appearing to fall within the claims of our formulation
patent; a salt or crystalline form not claimed by our composition of matter patent; or an indication not covered by our method of use
patent. See “Item 3. Key Information — D. Risk Factors — Risks Relating to Legal and Regulatory Matters — We rely on our patents
and other proprietary rights to provide exclusive rights to market certain of our medicines and vaccines. If such patents and other
rights were limited, invalidated, or circumvented, our financial results could be adversely affected” As disclosed in Item 8. of this
annual report, we are involved in significant litigation concerning the patent protection of a number of our products.
In addition to directly challenging our intellectual property rights, in some circumstances a competitor may be able to market a
generic version of one of our products.
In the US, competitor generic companies can challenge patents by filing Abbreviated New Drug Applications (ANDAs) to receive
authority to market a generic version of our approved products, by demonstrating that the purportedly generic version has the
same properties (safety and other technical data) as the original approved product. Our products and patents are also subject to
challenge by under section 505(b)(2) of the US Federal Food, Drug, and Cosmetic Act, which allows for approval for a wide range
of products, especially for those products that represent only a limited change from an existing approved drug.
Similarly, entities wishing to market a generic biologic can utilize an abbreviated approval pathway established in the PHS Act.
This §351(k) pathway enables an applicant to rely on a reference product sponsor’s data when seeking approval of a biological
product shown to be biosimilar (highly similar with no clinically meaningful differences) or interchangeable with an FDA-licensed
reference BLA product. See also “— B.5.3. Regulatory Framework” above.
In the EU, a generic drug manufacturer may only reference the data of the regulatory file for the original approved product after
data exclusivity has expired. Generic products may be approved for marketing following the expiration of marketing exclusivity
without regard to the patent holder’s rights. Nevertheless, in most of these jurisdictions once the competing product is launched,
and in some jurisdictions even prior to launch (once launch is imminent), the patent holder may seek an injunction against such
marketing if it believes its patents are infringed. See Item 8. of this annual report.
We seek to defend our patent rights vigorously in these cases. Success or failure in the assertion of a given patent against a
competing product is not necessarily predictive of the future success or failure in the assertion of the same patent. See “Item 3.
Key Information — D. Risk Factors — Risks Relating to Legal and Regulatory Matters — We rely on our patents and other
proprietary rights to provide exclusive rights to market certain of our medicines and vaccines. If such patents and other rights
were limited, invalidated, or circumvented, our financial results could be adversely affected.”
B.7. Production and raw materials
We have opted to manufacture the majority of our products in-house. There are three principal stages in our production process:
the manufacture of active ingredients, the transformation of those ingredients into drug products or vaccines, and the final
packaging.
Our general policy is to produce our key active ingredients and main drug products at our own plants in order to reduce our
dependence on external suppliers. We also rely on third parties for the manufacture and supply of specific active ingredients,
drug products and medical devices. Active ingredients are manufactured using raw materials sourced from suppliers who have
been subject to rigorous selection and approval procedures, in accordance with international standards and our own internal
directives. We have outsourced some of our production under supply contracts associated with acquisitions of products or
businesses or with Sanofi plant divestitures, or to establish a local presence to capitalize on growth in emerging markets. Our
pharmaceutical subcontractors follow our general quality and logistics policies, as well as meeting other criteria.
We also obtain active ingredients from third parties under collaboration agreements. This applies in particular to the monoclonal
antibodies developed with Regeneron.
Our production sites are divided into three categories:
•global sites, which serve all markets: located mainly in Europe, these facilities are dedicated to the manufacture of our active
ingredients, injectable products, and a number of our main solid-form products;
•regional sites, which serve markets at regional level, giving us a strong industrial presence in emerging markets; and
•local sites, which serve their domestic market only.
Vaccines produces vaccines at various sites, with the main locations situated in France, the US, Canada, India, Mexico and China.
The pharmaceutical site at Le Trait (France) also contributes to Vaccines’ industrial operations by making its sterile filling facilities
available for vaccine manufacturing.
All of our production facilities are good manufacturing practice (GMP) compliant, in line with international regulations.
SANOFI FORM 20-F 2025 | 49 |
PART I |
ITEM 4. Information on the Company |
Our main sites are approved by the FDA:
•the Specialty Care facilities in the US (Framingham MA and Northborough MA), France (Lyon Gerland, Vitry-sur-Seine,
Le Trait), Germany (Frankfurt), Ireland (Waterford) and Belgium (Geel);
•the General Medicines facilities in Germany (Frankfurt), France (Aramon, Sisteron, Ploermel, Ambarès and Tours), Italy (Anagni
and Scoppito), Singapore (Jurong) and the US (Ridgefield NJ);
•the Vaccines facilities in France (Marcy l’Étoile, Le Trait, Val-de-Reuil and Neuville-sur-Saône), the US (Swiftwater PA) and
Canada (Toronto); and
•during 2025, the Opella facilities approved by FDA in France (Compiègne) and the US (Chattanooga TN) were divested as part
of the Opella divestment. More details are given above at section "— B.3. Opella.”
Wherever possible, we seek to have multiple plants approved for the production of key active ingredients and our strategic
finished products (this is the case with Lovenox and Dupixent, for example).
More details about our manufacturing sites are given below at section “— D. Property, Plant and Equipment.”
B.8. Insurance and risk coverage
We are protected by five main insurance programs, relying not only on the traditional corporate insurance and reinsurance
market but also on our direct insurance company, Carraig Insurance DAC (Carraig).
These five key programs cover Property & Business Interruption; General & Product Liability; Stock & Transit; loss and liability
arising from cyber and digital risks; and Directors & Officers Liability.
Carraig participates in our coverage for various lines of insurance including Property, Stock & Transit, Cyber/Digital, and General
& Product Liability. Carraig is run under the supervision of the Irish and European regulatory authorities, is wholly owned by
Sanofi, and has sufficient resources to meet those portions of our risks that it has agreed to cover.
Carraig sets premiums for our entities at market rates. Claims are assessed using the traditional models applied by insurance and
reinsurance companies, and Sanofi's reserves are regularly verified and confirmed by independent actuaries.
Our Property & Business Interruption program covers all our entities worldwide, in all territories where it is possible to use a
centralized program operated by Carraig. By sharing risk between our entities, this approach enables us to set deductibles and
cover appropriate to the needs of local entities before the market attachment point. It also incorporates a prevention program,
including a comprehensive site visit schedule covering our production, storage, research and distribution facilities and
standardized repair and maintenance procedures across all sites.
The Stock & Transit program protects all goods owned by Sanofi while they are in transit nationally or internationally, whatever
the means of transport, and all our inventories wherever they are located. Sharing risk between our entities through Carraig
means that we can set deductibles at appropriate levels, for instance differentiating between goods that require temperature
controlled distribution and those that do not. We have developed a prevention program with assistance from experts,
implementing best practices in this area at our distribution sites.
Our Cyber/Digital insurance program protects our operations against loss originating from various sources, and against liability in
respect of data security. Centralized through Carraig, the program enables us to set deductibles and cover appropriate to the
needs of local entities before the market attachment point.
Our General & Product Liability program was renewed in 2025 for all our subsidiaries worldwide in all territories where it was
possible to do so. For several years, insurers have been reducing product liability coverage because of the difficulty of
transferring risk for some products that have been subject to numerous claims.
The principal risk exposure for our pharmaceutical products is covered with low deductibles at country level, with a greater
proportion of risk being retained. The level of risk self-insured by Sanofi (including via Carraig) before the market attachment
point enables us to retain control over the management and prevention of risk. Our negotiations with third-party insurers and
reinsurers are tailored to our specific risks. In particular, they allow for differential treatment of products in the development
phase, for discrepancies in risk exposure between European countries and the US and for specific issues arising in certain
jurisdictions. Coverage is adjusted every year to take account of the relative weight of new product liability risks such as those
arising out of biotechnologies and new technology platforms.
Our coverage for risks that are not specific to the pharma-biotech industry (general liability) is designed to address the potential
impacts of our operations.
For all the insurance programs handled by Carraig, outstanding claims are covered by provisions for the estimated cost of settling
all claims incurred but not paid at the balance sheet date, whether reported or not, together with all related claims handling
expenses. Where there is sufficient data history from Sanofi or from the market for claims made and settled, management – with
assistance from independent actuaries – prepares an actuarial estimate of our exposure to unreported claims for the risks
covered. The actuaries perform an actuarial valuation of the company’s Incurred But Not Reported (IBNR) and Allocated Loss
Adjustment Expense (ALAE) liabilities at year end. Two ultimate loss projections (based upon reported losses and paid losses,
respectively) are computed each year using various actuarial methods including the Bornhuetter-Ferguson method; those
projections form the basis for the provisions set.
The Directors & Officers Liability program protects all legal entities under our control, and their directors and officers. Carraig is
not involved in this program.
50 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 4. Information on the Company |
We also operate other insurance programs, but these are of much lesser importance than those described above.
All our insurance programs are backed by highly-rated insurers and reinsurers and are intended to be designed in such a way that
we can integrate most newly acquired businesses without interruption of cover. Our insurance coverage has been designed to
reflect our risk profile and the capacity available in the insurance market. By centralizing our major programs, we are able to
provide what we believe to be excellent, cost effective protection.
B.9. Health, Safety, and Environment
Our manufacturing and research operations are subject to increasingly stringent health, safety and environmental (HSE) laws and
regulations. These laws and regulations are complex and rapidly changing, and Sanofi invests the necessary sums in order to
comply with them. This investment, which aims to respect HSE matters, varies from year to year.
Applicable environmental laws and regulations may require us to reduce the effects of chemical substance discharge at our
various sites. The sites in question may belong to Sanofi, and may be currently operational, or may have been owned or
operational in the past. In this regard, Sanofi may be held liable for the costs of removal or remediation of hazardous substances
on, under or in the sites concerned, or on sites where waste from activities has been stored, without regard to whether the owner
or operator knew of or under certain circumstances caused the presence of the contaminants, or at the time site operations
occurred the discharge of those substances was authorized.
As is the case for a number of companies in the pharmaceutical, chemical and intense agrochemical industries, soil and
groundwater contamination has occurred at some of our sites in the past, and may still occur or be discovered at others. In
Sanofi’s case, such sites are mainly located in the US, Germany and France. As part of a program of environmental surveys
conducted over the last few years, detailed assessments of the risk of soil and groundwater contamination have been carried out
at current and former Sanofi sites. In cooperation with national and local authorities, Sanofi regularly assesses the rehabilitation
work required and carries out such work when appropriate. Remediation works have just been completed at Beaucaire in France.
Long-term rehabilitation work is in progress or planned in Mount Pleasant, Portland in the US; Frankfurt in Germany; Valernes,
Septèmes and Limay in France; and on a number of sites divested to third parties and covered by contractual environmental
guarantees granted by Sanofi.
We may also have potential liability for investigation and clean-up at several other sites. We have established provisions for the
sites already identified and to cover contractual guarantees for environmental liabilities for sites that have been divested. In
France specifically, we have provided the financial guarantees to the authorities as required under French regulations for
environmental protection in connection with the operation of activities on French sites.
Potential environmental contingencies arising from certain business divestitures are described in Note D.22.d. to the consolidated
financial statements. In 2025, Sanofi spent €31 million on rehabilitating sites previously contaminated by soil or groundwater
pollution.
Due to changes in environmental regulations governing site remediation, our provisions for remediation obligations may not be
adequate due to the multiple factors involved, such as the complexity of operational or previously operational sites, the nature of
claims received, the remediation techniques involved, the planned timetable for rehabilitation, and the outcome of discussions
with national regulatory authorities or other potentially responsible parties, as in the case of multiparty sites. Given the long
industrial history of some of our sites and the legacy obligations arising from the past involvement of Aventis in the chemical and
agrochemical industries, it is impossible to quantify the future impact of these laws and regulations with precision.
See “Item 3.D. Risk Factors — Environmental and safety risks of our industrial activities.”
We have established, in accordance with our current knowledge and projections, provisions for cases already identified and to
cover contractual guarantees for environmental liabilities relating to sites that have been divested. In accordance with
Sanofi standards, a comprehensive review is carried out once a year on the legacy of environmental pollution. In light of
data collected during this review, we adjusted our provisions to €493 million as of December 31, 2025 versus €474 million as
of December 31, 2024. The terms of certain business divestitures, and the environmental obligations and retained environmental
liabilities relating thereto, are described in Note D.22. to our consolidated financial statements.
To our knowledge, Sanofi did not incur any liability in 2025 for non-compliance with current HSE laws and regulations that could
be expected to significantly jeopardize its activities, financial situation or operating income. We also believe that we are in
substantial compliance with current HSE laws and regulations and that all the environmental permits required to operate our
facilities have been obtained.
Regular HSE audits are carried out by Sanofi in order to assess compliance with standards (which implies compliance with
regulations) and to initiate corrective measures (26 entities audited, grouped into 21 internal audits performed in 2025). Moreover,
in 2025, 180 specific visits were performed jointly with experts representing our insurers.
Sanofi has implemented a worldwide master policy on HSE to promote the health and well-being of the employees and
contractors working on its sites and respect for the environment. We consider this master policy to be an integral part of our
commitment to social responsibility. In order to implement this master policy, Sanofi key requirements have been drawn up in the
key fields of HSE management, HSE leadership, safety in the workplace, process safety, occupational hygiene, health in the
workplace and protection of the environment. However, despite these efforts, Sanofi may be unsuccessful in the implementation
of its policy to reduce and mitigate the harmful effects of its activities on the health and safety of its employees, customers or the
general public and on the environment more generally. See “Item 3. Key information — D. Risk Factors” for further information.
SANOFI FORM 20-F 2025 | 51 |
PART I |
ITEM 4. Information on the Company |
Health
From the development of compounds to the commercial launch of new drugs, Sanofi research scientists continuously assess the
effect of products on human health. This expertise is made available to employees through two committees responsible for
chemical and biological risk assessment. Sanofi’s COVALIS (Comité des Valeurs Limites Internes Sanofi) Committee is responsible
for the hazard determination and classification of all API and synthesis intermediates handled at Sanofi facilities. This covers all
active ingredients handled in production at company sites or in processes sub-contracted for manufacture. Any important issues
involving raw materials or other substances that lack established occupational exposure limits may also be reviewed. The
COVALIS Committee determines the occupational exposure limits required within Sanofi. Our TRIBIO Committee is responsible
for classifying all biological agents according to their degree of pathogenicity and virulence, and applies rules for their
containment and the preventive measures to be respected throughout Sanofi. See “Item 3. Key Information — D. Risk Factors
— Environmental and safety risks of our industrial activities — Risks from manufacturing activities and the handling of hazardous
materials could adversely affect our results of operations and reputation.”
Appropriate occupational hygiene practices and programs are defined and implemented in each site. These practices consist
essentially of containment measures for collective and individual protection against chemical and biological exposure in all
workplaces where chemical substances or biological agents are handled. All personnel are monitored with an appropriate medical
surveillance program, based on the results of professional risk evaluations linked to their duties.
In addition, dedicated resources have been created to implement the European Regulation on Registration, Evaluation,
Authorization and Restriction of Chemicals (REACH) and the European Regulation on Classification, Labeling and Packaging of
chemicals (CLP). To fully comply with REACH, Sanofi has registered the relevant hazardous chemical substances with the
European Chemicals Agency (ECHA).
While these measures focus on managing chemical and biological risks, Sanofi's commitment to employee well-being extends
beyond safety protocols. Through the All Well program, Sanofi offers comprehensive health and wellbeing support to all its
employees. This program supports mental and physical health, providing various global and local resources to promote healthy
nutrition, physical activity, vaccination, and health checkups, as well as a Global Employee Assistance Program, ensuring a holistic
approach to employee health and safety.
Safety
Sanofi has rigorous policies to identify and evaluate safety risks and to develop preventive safety measures, and methods for
checking their efficacy. Additionally, Sanofi invests in training that is designed to instill in all employees a sense of concern for
safety, regardless of their duties. These policies are implemented on a worldwide scale to ensure the safety of all employees and
to protect their health. Each project, whether in research, development or manufacturing, is subject to evaluation procedures,
incorporating the chemical substance and process data communicated by the COVALIS and TRIBIO Committees described
above. The preventive measures are designed primarily to reduce the number and seriousness of work accidents and to minimize
exposures involving permanent and temporary Sanofi employees as well as our sub-contractors.
The French chemical manufacturing sites in Aramon and Sisteron are upper-tier Seveso sites according to the Seveso III
regulations (from the name of the European directive that deals with potentially dangerous establishments where dangerous
substances may be present in quantities exceeding certain thresholds to prevent major accidents and limit their consequences).
In accordance with French law on technological risk prevention, the French sites are also subject to heightened security
inspections due to the toxic or flammable materials stored on the sites and used in the operating processes. In Europe, our
Frankfurt site is listed as a lower-tier Seveso site.
Risk assessments of processes and installations are drawn up according to standards and internal guidelines incorporating the
best state of the art benchmarks for the industry. These assessments are used to fulfill regulatory requirements and are regularly
updated. Particular attention is paid to any risk-generating changes such as process or installation changes, as well as changes in
production scale and transfers between industrial or research units.
We are using specialized process safety-testing laboratories that are fully integrated into our chemical development activities,
apply methods to obtain the physico-chemical parameters of manufactured chemical substances (intermediate chemical
compounds) and apply models to measure the effect of potentially leachable substances in the event of a major accident. In
these laboratories the parameters for qualifying hazardous reactions are also determined, in order to define scale-up process
conditions while transferring from development stage to industrial scale. We use these data to enhance the relevance of our risk
assessments.
We believe that the safety management systems implemented at each site, the hazard studies carried out and the risk
management methods implemented, as well as our third-party property insurance policies covering any third-party physical
damage, are consistent with legal requirements and the best practices in the industry, although no guarantee can be given that
they will prevent accidents of various kinds.
We have also designed a new Global Safety Culture program – “Leading Safety” – to help protect the health and safety of our
employees, contractors and communities. It is based on five positive performance drivers: strengthen safety leadership; focus on
key risks; increase managerial skills; improve safety barriers and the effectiveness of controls; and increase reports of unsafe acts
& hazardous conditions.
52 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 4. Information on the Company |
Environment
Beyond healthcare, we have taken steps to address the environmental impacts of our products and activities and to help
strengthen our resilience in the face of environmental changes. We have identified a number of environmental challenges
relevant to our businesses: greenhouse gas emissions and climate disruption; eco-design; water; pharmaceuticals in the
environment; waste; and biodiversity.
We have been implementing environmental initiatives since 2010. More recently, we established the Planet Care program, which
seeks to address environmental impacts across the value chain.
We have also taken measures to seek to reduce our greenhouse gas emissions and to promote circularity and the use of
sustainable resources. We have set both medium-term and long-term targets. See “Cautionary statement regarding
forward-looking statements” and “Item 3.D. Risk Factors.”
C. Organizational Structure
C.1. Significant Subsidiaries
Sanofi is the holding company of a consolidated group consisting of almost 200 companies. The table below sets forth
our significant subsidiaries as of December 31, 2025. For a fuller list of the principal companies in our consolidated group, see
Note F. to our consolidated financial statements included at Item 18. of this annual report.
Significant subsidiary | Date of incorporation | Country of incorporation | Principal activity | Financial and voting interest |
Aventis, Inc. | July 1, 1968 | United States | Pharmaceuticals | 100% |
Bioverativ Therapeutics, Inc. | June 17, 1997 | United States | Pharmaceuticals | 100% |
Genzyme Corporation | November 21, 1991 | United States | Pharmaceuticals | 100% |
Hoechst GmbH | July 8, 1974 | Germany | Pharmaceuticals | 100% |
Sanofi-Aventis Deutschland GmbH | June 30, 1997 | Germany | Pharmaceuticals | 100% |
Sanofi-Aventis Participations SAS | February 25, 2002 | France | Pharmaceuticals | 100% |
Sanofi-Aventis Singapore Pte Ltd | May 14, 1997 | Singapore | Pharmaceuticals | 100% |
Sanofi Biotechnology | December 23, 2013 | France | Pharmaceuticals | 100% |
Sanofi Foreign Participations B.V. | April 29, 1998 | Netherlands | Pharmaceuticals | 100% |
Sanofi Pasteur | February 8, 1989 | France | Pharmaceuticals | 100% |
Sanofi Pasteur, Inc. | January 18, 1977 | United States | Pharmaceuticals | 100% |
We have transformed Sanofi through numerous acquisitions and divestments, in particular the deconsolidation of EUROAPI in
May 2022 and the divestment of Opella in April 2025 (for a description of the main such events over the past three years, refer to
“A. History and Development of the Company” above).
In certain countries, we carry on some of our business operations through joint ventures with local partners. In addition, we have
entered into worldwide collaboration agreements, in particular with Regeneron on Dupixent and Kevzara and with AztraZeneca
on Beyfortus. For further information, refer to Note C. “Principal Alliances” to our consolidated financial statements, included at
Item 18. of this annual report.
C.2. Internal organization of activities
Sanofi and its subsidiaries collectively form a group organized around a Biopharma operating segment (Immunology, Rare
diseases, Neurology, Oncology, Other Medicines, and Vaccines). See “Item 5. Operating and Financial Review and Prospects —
A.1.1. 2025 Overview.”
Sanofi's R&D function is structured around two main areas:
•Medicines: under the responsibility of Sanofi and Genzyme Corporation; and
•Vaccines: under the responsibility of Sanofi Pasteur and Sanofi Pasteur, Inc.
The R&D organization operates in an integrated manner on a global scale, with centralized definition of strategic priorities and
global coordination of research programs. These main entities subcontract research and development activities to subsidiaries
with the appropriate technical and scientific capabilities.
Sanofi and its main subsidiaries grant licenses for patents, manufacturing know-how, and trademarks to their French and
international subsidiaries. These licensed subsidiaries handle the manufacturing, marketing, and distribution of Sanofi medicines
and vaccines, either directly to end customers or through local distribution subsidiaries.
Our industrial property rights, patents and trademarks are mainly held by the following legal owner: Sanofi, Sanofi Biotechnology,
and Sanofi R&D Vaccins (formerly Sanofi Pasteur) (France); Sanofi-Aventis Deutschland GmbH (Germany); Ablynx (Belgium);
Kymab Ltd (UK;, Genzyme Corporation, Bioverativ, Inc., Kadmon Corporation LLC, Amunix Pharmaceuticals, Inc., Principia
Biopharma, Inc., Sanofi Vaccines US Inc (formerly Sanofi Pasteur, Inc.), sanofi-aventis US LLC, Translate Bio , Synthorx, Inc., and
Provention Bio, Inc. (US); and Sanofi Vaccines Canada Ltd (formerly Sanofi Pasteur Limited) (Canada).
SANOFI FORM 20-F 2025 | 53 |
PART I |
ITEM 4. Information on the Company |
For a description of our principal items of property, plant and equipment, see “— D. Property, Plant and Equipment” below. Our
property, plant and equipment is held mainly by the following companies:
•in France: Sanofi Pasteur SA, Sanofi Winthrop Industrie and Sanofi-Aventis Recherche & Développement;
•in the US: Sanofi Pasteur, Inc., Genzyme Therapeutics Products LP, Genzyme Corporation and Translate Bio;
•in Germany: Sanofi-Aventis Deutschland GmbH;
•in Canada: Sanofi Pasteur Limited;
•in Belgium: Genzyme Flanders BVBA; and
•in Ireland: Genzyme Ireland Limited.
C.3. Financing and financial relationships between group companies
The Sanofi parent company raises the bulk of the Company’s external financing and uses the funds raised to meet, directly or
indirectly, the financing needs of its subsidiaries. The parent company operates a cash pooling arrangement under which any
surplus cash held by subsidiaries is managed centrally. There is also a centralized foreign exchange risk management system in
place, whereby the parent company contracts hedges to meet the needs of its principal subsidiaries.
Consequently, at December 31, 2025, the Sanofi parent company held 93% of our external financing and 83% of our surplus cash.
In addition, the Sanofi parent company, plus the wholly-owned Sanofi subsidiaries Sanofi European Treasury Center SA (SETC)
and/or Genzyme Ireland Limited, provide financing and certain financial services to Sanofi subsidiaries.
D. Property, Plant and Equipment
D.1. Overview
Our headquarters are located in Paris, France.
We operate our business through office premises and research, production and logistics facilities in approximately 60 countries
around the world. Our office premises house all of our support functions, plus operational representatives from our subsidiaries
and the Company.
A breakdown of our sites by use and by ownership status (owned versus leasehold) is provided below. This breakdown is based on
surface area. All surface area figures are unaudited.
Breakdown of sites by use | Breakdown of sites by ownership status | |||
Industrial | Leasehold | |||
Research | Owned | |||
Offices | ||||
Logistics | ||||
Other | ||||
D.2. Description of our sites
Sanofi industrial sites
As part of the process of transforming Sanofi and creating Global Business Units, we are continuing to adapt the organization of
the Manufacturing & Supply department in support of our new business model.
The Manufacturing & Supply department focuses on customer needs and service quality; the sharing of “Sanofi Manufacturing
System” good manufacturing practices; and the development of a common culture committed to quality.
The organizational structure of Manufacturing & Supply is aligned on our corporate structure and our three Global Business Units:
Specialty Care, General Medicines and Vaccines..
The Manufacturing & Supply department is also responsible for Sanofi Global HSE and Global Supply Chain.
At the end of 2025, we were carrying out industrial production at 37 sites in 19 countries:
•8 sites for our Specialty Care operations;
•19 sites for our General Medicines operations; and
•9 sites for the industrial operations of Vaccines.
During 2025, 13 sites were divested as part of the Opella divestment (see “Item 5. Operating and Financial Review and Prospects
— A.1.1. 2025 Overview”).
The quantity of units sold in 2025, including in-house and outsourced production, was 2 billion units.
54 | SANOFI FORM 20-F 2025 |
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ITEM 4. Information on the Company |
We believe that our production facilities are in compliance with all material regulatory requirements, are properly maintained and
are generally suitable for future needs. We regularly inspect and evaluate those facilities with regard to environmental, health,
safety and security matters, quality compliance and capacity utilization. For more information about our property, plant and
equipment, see Note D.3. to our consolidated financial statements, included at Item 18. of this annual report, and
section “B.7. Production and Raw Materials” above.
Our main production sites by volume are:
•Le Trait (France), Frankfurt (Germany), Waterford (Ireland), Geel (Belgium) and Framingham (US) for Specialty Care;
•Aramon, Sisteron and Ambarès (France), Frankfurt (Germany), Csanyikvölgy (Hungary), Lüleburgaz (Turkey), Campinas (Brazil),
Jurong (Singapore) and Hangzhou (China) for General Medicines; and
•Marcy-l’Étoile and Val-de-Reuil (France), Toronto (Canada) and Swiftwater (US) for Vaccines.
Research & Development sites
In Pharmaceuticals, research and development activities are conducted at the following sites:
•two operational sites in France: Montpellier and Vitry-sur-Seine/Alfortville;
•two sites in the rest of Europe (Germany and Belgium), the larger of which is in Frankfurt (Germany);
•three sites in the US: Bridgewater, Cambridge and Framingham/Waltham ; and
•three sites in China (Beijing, Shanghai and Chengdu).
In Vaccines, research and development activities are conducted at the following sites:
•Swiftwater, Cambridge and Orlando (US);
•Marcy-l’Étoile/Lyon (France); and
•Toronto (Canada).
D.3. Acquisitions, capital expenditures and divestitures
The carrying amount of our property, plant and equipment at December 31, 2025 was €10,052 million. During 2025, we
invested €1,822 million (see Note D.3. to our consolidated financial statements, included at Item 18. of this annual report),
mainly in increasing capacity and improving productivity at our various production and R&D sites.
Our principal acquisitions, capital expenditures and divestitures in 2023, 2024 and 2025 are described in Notes D.1. and D.2.
(“Changes in the scope of consolidation”), D.3. (“Property, plant and equipment”) and D.4. (“Goodwill and other intangible
assets”) to our consolidated financial statements, included at Item 18. of this annual report. For associated commitments, and
in particular future contingent milestone payments, refer to Notes D.18 and D.21. to our consolidated financial statements,
which provide disclosures about liabilities related to business combinations and our principal research and development
collaboration agreements, respectively.
As of December 31, 2025, our firm commitments in respect of future capital expenditures amounted to €926 million. The
principal locations involved are: for medicines, the industrial facilities at Frankfurt (Germany); Le Trait, Lyon, Aramon, Sisteron
and Vitry (France); Cambridge (US); Geel (Belgium); Waterford (Ireland); Anagni and Scoppito (Italy); Shuand Xi (China); and for
vaccines, the facilities at Swiftwater (US); Toronto (Canada); Marcy-l’Étoile, Neuville-sur-Saône and Val-de-Reuil (France); and
Tuas (Singapore).
In the medium term and assuming no changes in the scope of consolidation, we expect to invest on average approximately
€1.75 billion a year in property, plant and equipment. We believe that our own cash resources and the undrawn portion of our
existing credit facilities will be sufficient to fund these expenditures.
Our principal ongoing capital expenditures are described below.
Medicines
Our Medicines industrial operations are organized through end-to-end clusters.
We have four dedicated biotechnology hubs: Paris/Lyon (France), Frankfurt (Germany), Geel (Belgium) and the Boston area
(US). Exploiting innovative techniques, including cell and microbiological culture and the development of viral vectors, our
biotechnology operations call for highly specific knowledge and expertise backed by dedicated production platforms to
support global product launches.
We also have end-to-end clusters with chemistry, pharmaceutical and injectable sites organized through a network of regional
and local industrial sites, supporting growth in those markets. A dedicated Launch Sites cluster has been implemented, from
API manufacturing to finished goods packaging (Sisteron, Aramon, Ambarès, Scoppito). The Frankfurt facility is our principal
site for the manufacture of diabetes treatments. Also in 2024, we announced major investments in the production of insulin
APIs, at new facilities in Frankfurt (Germany) and Beijing (China).
SANOFI FORM 20-F 2025 | 55 |
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ITEM 4. Information on the Company |
Vaccines
The industrial operations of our Vaccines business are in a major investment phase, preparing for the upcoming growth of our
influenza and Polio/Pertussis/Hib franchises, plus the mid-term growth linked to our mRNA roadmap and New Vaccines
pipeline. Major investments were announced in 2020 and 2021 with a new Evolutive Facility in France (Neuville-Sur-Saone) and
a new facility in Singapore for our New Vaccines pipeline. Other major investments are under way in France (including
construction of a new influenza vaccine building at Val-de-Reuil), Canada (a new pertussis vaccine building), the US and
Mexico.
Innovation and culture of industrial excellence
The ambition of our Manufacturing & Supply department is to continue to raise safety, quality and operating standards in Sanofi’s
production activities, and to remain a world leader and a benchmark in the global pharmaceutical industry. To achieve this goal,
all our activities share a common culture of industrial excellence, enshrined in the Sanofi Manufacturing System. This sets out a
series of priorities (such as customer service, constant improvement, site network optimization and transverse optimization) that
constitute our industrial vision and will be crucial to our mutual success.
In terms of operational excellence, we continue to build on our Top Decile performance program, focused on core sites and fully
leveraging digital opportunities and technology innovations. We are also reinforcing the Sanofi Manufacturing System to drive
more improvement directly from the sites and reach our performance goals, while creating a culture of best practices shared
across the industrial network.
56 | SANOFI FORM 20-F 2025 |
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ITEM 4. Information on the Company |
E. R&D Appendix
R&D Pipeline
Registration | ||
Name | Description | Indication |
Dupixent(a) | IL4R mAb | Allergic fungal rhinosinusitis (US) Bullous pemphigoid (EU, JP) |
teplizumab | CD3 mAb | Type 1 diabetes, stage 3 (US) |
Wayrilz | BTK inhibitor | Immune thrombocytopenia (JP) |
tolebrutinib | BTK inhibitor | Secondary progressive MS (US, EU) |
Sarclisa | CD38 mAb subcutaneous | Relapsed/refractory MM |
Phase 3 | ||||||
Name | Description | Indication | Name | Description | Indication | |
Immunology | Rare diseases | |||||
amlitelimab | OX40L mAb | Atopic dermatitis | Nexviazyme | Enzyme replacement therapy | Infantile-onset Pompe disease | |
Dupixent (a) | IL4R mAb | Chronic pruritus of unknown origin Lichen simplex chronicus | elenestinib | D816V-mutated KIT inhibitor | Indolent/smoldering systemic mastecytosis | |
duvakitug (b) | TL1A mAb | Crohn’s disease Ulcerative colitis | fitusiran | RNAi targeting anti- thrombin | Hemophilia A and B (EU, JP) | |
itepekimab (a) | IL33 mAb | Chronic obstructive pulmonary disease (1) Chronic rhinosinusitis with nasal polyps | Wayrilz | BTK inhibitor | Sickle cell disease IgG4-related disease Warm autoimmune hemolytic anemia | |
lunsekimig | IL13×TSLP Nanobody® VHH | Chronic obstructive pulmonary disease | venglustat | Oral GCS inhibitor | Fabry disease Gaucher disease type 3 | |
Rezurock | ROCK2 inhibitor | Chronic lung allograft dysfunction | ||||
Neurology | Oncology | |||||
frexalimab (c) | CD40L mAb | Relapsing MS Non-relapsing secondary progressive MS | Sarclisa | CD38 mAb | NDMM, TE (HD7) (US) NDMM, TE (IsKia) Smoldering MM (ITHACA) | |
riliprubart | C1s mAb | SOC-refractory CIDP IVIg-treated CIDP | ||||
Vaccines | ||||||
SP0087 | Vero cell vaccine | Rabies | ||||
SP0218 | Vero cell vaccine | Yellow fever | ||||
Fluzone HD | Multivalent inactivated vaccine | Flu (50 years+) | ||||
SP0202(d) | 21-valent conjugate vaccine | Pneumococcal disease (children) | ||||
(1) itepekimab’s future development in COPD is dependent on further analysis of Phase 3 data and regulatory feedback.
Collaborations: (a) Regeneron; (b) Teva Pharmaceuticals; (c) ImmuNext; (d) SK biosience.
Abbreviations:
BTK: Bruton’s tyrosine kinase – CD: Cluster of differentiation – C1s: Complement component 1s – CIDP: Chronic inflammatory demyelinating polyneuropathy – CN: China –
EU: Europe – GCS: Glucosylceramide synthase – HD: High dose – IgG4: Immunoglobulin G4 – IL: Interleukin – IVIg: Intravenous immunoglobulin – JP: Japan – mAb:
Monoclonal antibody - MM: Multiple myeloma - MS: Multiple sclerosis - NDMM: Newly diagnosed multiple myeloma - RNAi: RNA interference - ROCK2: Rho Associated
coiled-coil containing protein kinase 2 – SOC: Standard of care – TE: Transplant eligible – TL1A: Tumor necrosis factor-like cytokine 1A – TSLP: Thymic stromal
lymphopoietin
SANOFI FORM 20-F 2025 | 57 |
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ITEM 4. Information on the Company |
Phase 2 | ||||||
Name | Description | Indication | Name | Description | Indication | |
Immunology | Rare diseases | |||||
amlitelimab | OX40L mAb | Asthma | Wayrilz | BTK inhibitor | Graves' disease | |
balinatunfib | oral TNFR1 signaling inhibitor | Crohn’s disease Ulcerative colitis | efdoralprin alfa | AAT fusion protein | Alpha-1 antitrypsin deficiency emphysema | |
brivekimig | TNFa×OX40L Nanobody® VHH | Crohn’s disease Hidradenitis suppurativa Ulcerative colitis Type 1 diabetes, stage 3 | frexalimab rilzabrutinib brivekimig | CD40L mAb BTK inhibitor TNFa×OX40L Nanobody® VHH | Focal segmental glomerulosclerosis/ minimal change disease | |
frexalimab(a) | CD40L mAb | Type 1 diabetes | ||||
itepekimab(b) | IL33 mAb | Chronic rhinosinusitis without nasal polyps | Oncology | |||
lunsekimig | IL13×TSLP Nanobody® VHH | Asthma Asthma, high-risk Atopic dermatitis Chronic rhinosinusitis with nasal polyps | SAR445877 | PD1×IL15 fusion protein | Solid tumors | |
riliprubart | C1s mAb | Antibody-mediated rejection | Sarclisa | CD38 mAb | Relapsed/refractory multiple myeloma in combination | |
rilzabrutinib | BTK inhibitor | Asthma Chronic spontaneous urticaria | ||||
SAR449028 | Wild-type KIT inhibitor | Chronic induced/ spontaneous urticaria Allergic rhinoconjunctivitis | Vaccines | |||
SAR444336 | Non-beta IL2 Synthorin | Microscopic colitis | SP0230 | 5-valent (ACWY+B) vaccine | Meningitis | |
SAR445399 (1) | IL1R3 mAb | Hidradenitis suppurativa | SP0256 | mRNA vaccine | RSV+hMPV (older adults) | |
SP0268 | mRNA vaccine | Acne | ||||
Neurology | SP0289 | mRNA vaccine | Flu H5 pandemic | |||
SAR402663 | sFLT01 AAV gene therapy | Wet age-related macular degeneration | SP0335 | Inactivated adjuvanted vaccine | Flu H5 pandemic | |
Phase 1 | ||||||
Name | Description | Indication | Name | Description | Indication | |
Immunology | Oncology | |||||
SAR446422 | CD28×OX40 bispecific Ab | Inflammatory indication | SAR445953 (d) | CEACAM5-Topo1 ADC | Colorectal cancer | |
SAR446959 | MMP13×ADAMTS5×CAP Nanobody® VHH | Knee osteoarthritis | SAR446523 | GPRC5D mAb | Relapsed/refractory multiple myeloma | |
SAR448501 | CD20 bispecific mAb | Inflammatory indication | ||||
SAR448755 (c) | STAT6 inhibitor | Inflammatory indication | Vaccines | |||
SP0287 | Fluzone HD+Nuvaxovid | Flu+COVID-19 | ||||
Neurology | SP0287 | Flublok+Nuvaxovid | Flu+COVID-19 | |||
SAR446597 | Bb×C1s AAV gene therapy | Geographic atrophy in dry age-related macular degeneration | SP0291 | mRNA vaccine | RSV+hMPV+PIV3 (older adults) | |
SAR448851 | TREM2 agonist | Alzheimer’s disease | SP0269 | mRNA vaccine | Chlamydia | |
SP0340 | Subunit vaccine | RSV+hMPV (older adults) | ||||
SP0341 | Subunit vaccine | RSV+hMPV+PIV3 (older adults) | ||||
Rare diseases | ||||||
SAR446268 | DMPK AAV gene therapy | Myotonic dystrophy type 1 | ||||
(1) Also known as MAB212, in-licensed from MAB Discovery.
Collaborations: (a) ImmuNext; (b) Regeneron; (c) Recludix; (d) Pfizer
Abbreviations:
AAT: Alpha–1 antitrypsin – AAV: Adeno-associated virus – Ab: Antibody – ADAMTS5: A Disintegrin And Metalloproteinase with Thrombospondin Motifs 5 –
ADC: Antibody-drug conjugate – Bb: Factor Bb – BTK: Bruton’s tyrosine kinase – C1s: Complement component 1s – CAP: Cartilage anchoring protein – CD:
Cluster of differentiation – CEACAM5: Carcinoembryonic antigen cell adhesion molecule 5 – DMPK: dystrophia myotonica protein kinase 1 – GPRC5D: G-
protein-coupled receptor class 5 member D – H5: hemagglutinin 5 - hMPV: human Metapneumovirus – IL: Interleukin – IL1R3: Interleukin-1 receptor 3 –
mAb: Monoclonal antibody – MMP13: Matrix metallopeptidase 13 – mRNA: messenger RNA – PD1: Programmed death protein 1 – PIV3: Parainfluenza virus
type 3 – RSV: Respiratory syncytial virus – STAT6: Signal transducer and activator of transcription 6 – TNFa: Tumor necrosis factor alpha – TNFR1: Tumor
necrosis factor receptor 1 – Topo1: Topoisomerase - TREM2: triggering receptor expressed on myeloid cells 2 – TSLP: Thymic stromal lymphopoietin
58 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 4A. Unresolved Staff Comments |
Item 4A. Unresolved Staff Comments
N/A
Item 5. Operating and Financial Review and Prospects
You should read the following discussion in conjunction with our consolidated financial statements and the notes thereto
included at Item 18. of this annual report.
Our consolidated financial statements have been prepared in accordance with International Financial Reporting Standards
(IFRS) as issued by the International Accounting Standards Board (IASB) and with IFRS endorsed by the European Union as
of December 31, 2025.
The following discussion contains forward-looking statements that involve inherent risks and uncertainties. Actual results may
differ materially from those contained in such forward-looking statements. See “Cautionary Statement Regarding Forward-
Looking Statements” at the beginning of this document.
Unless otherwise stated, all financial variations in this item are given on a reported basis.
The discussion of our operating and financial review and prospects for the years ended December 31, 2024 and December 31,
2023, including a presentation of our consolidated income statements for the years ended December 31, 2024 and December 31,
2023, can be found in “Item 5. Operating and Financial Review and Prospects — A. Operating results — A.2. Results of operations
— Year ended December 31, 2024 compared with year ended December 31, 2023” of our annual report on Form 20-F filed
on February 13, 2025.
A. Operating results
A.1. Significant operating information
A.1.1. 2025 Overview
2025 Business Developments
In 2025, Sanofi introduced the “Take the Lead” strategy to accelerate transformative impact for patients, healthcare systems,
and society, reinforcing its position as an R&D-driven, AI-powered biopharma company committed to improving people's lives
and delivering compelling growth. For further information about our strategy, refer to “Item 4. Information on the Company
— B. Business Overview — B.1. Strategy.” Other significant events of the year are described below.
During the meeting of the Board of Directors on January 29, 2025, the Board authorized Sanofi to repurchase an aggregate
amount of the Company's own shares not exceeding €5 billion, under the terms and conditions set by the General Meeting of
April 30, 2024 in its 19th resolution. Pursuant to this authorization, Sanofi entered into a share buyback agreement with its
historical shareholder L'Oréal on February 2, 2025 for the acquisition of 2.34% of Sanofi’s share capital, equivalent to
29,556,650 shares, for a total repurchase price of approximately €3 billion, representing a price of €101.50 per share. Following
the buyback, these shares were canceled during 2025 (see Note D.15.1. Share capital to our consolidated financial statements
included at Item 18. of this annual report). In addition, on February 6, 2025 Sanofi entered into a mandate with an investment
services provider to repurchase its own shares for a maximum aggregate amount of €2 billion between February 7, 2025 and
December 31, 2025. The share buyback program had been executed in full by the end of 2025.
As part of its Euro Medium Term Note program, Sanofi carried out two bond issues in the first half of 2025. On March 5, a first
issue of €1.5 billion was completed, comprising €850 million of floating-rate bonds (3-month Euribor + 0.300%) maturing in
March 2027, and €650 million of fixed-rate bonds (2.75% per annum) maturing in March 2031. On June 17, a second issue of
€1.5 billion was completed, consisting of two tranches of €750 million each: one at a fixed rate of 2.625% per annum, maturing in
June 2029, and the other at a fixed rate of 3.00% per annum maturing in June 2032. Sanofi will use the net proceeds from the
issuance of these bonds for general corporate purposes.
On April 30, 2025, Sanofi announced the closing of the transaction with Clayton, Dubilier & Rice (CD&R) relating to Sanofi’s
consumer healthcare business, Opella. In accordance with the terms announced on February 19, 2025, Sanofi has transferred a
controlling stake in Opella to CD&R. Sanofi retains a 48.2% equity interest in the associate OPAL JV Co, which indirectly holds
100% of Opella. Bpifrance holds a minority stake of 1.8% and is represented on Opella’s Board of Directors. As a result of the
transaction, Sanofi recognized a net gain of €2.6 billion, reported within the line item Net income from discontinued operations
in the consolidated income statement. Sanofi received total net cash proceeds of €10.4 billion, presented within the line item Net
cash inflow from the Opella transaction in the statement of cash flows.
On May 22, 2025, Sanofi announced that it had entered into an agreement to acquire Vigil Neuroscience, Inc. (Vigil), a publicly
traded clinical-stage biotechnology company focused on developing novel therapies for neurodegenerative diseases. This
acquisition in neurology, one of Sanofi’s four strategic disease areas, enhances Sanofi’s early-stage pipeline and includes
VG-3927, which will be evaluated in a phase 2 clinical study in Alzheimer’s disease. VG-3927 is an oral small molecule TREM2
agonist. Activating TREM2 is expected to enhance the neuroprotective function of microglia in Alzheimer’s disease. Under the
terms of a share purchase agreement (including the exclusive right of first negotiation for an exclusive license to VG-3927 or for
SANOFI FORM 20-F 2025 | 59 |
PART I |
ITEM 5. Operating and Financial Review and Prospects |
transfer of the rights to research, develop, manufacture, and commercialize VG-3927) entered into by Sanofi and Vigil in June
2024 for an amount of $40 million, Sanofi already held an equity interest in Vigil, representing approximately 12% of Vigil’s share
capital. That equity interest was remeasured through Other comprehensive income. VGL101, Vigil’s second molecule program,
was not acquired by Sanofi. On August 5, 2025, Sanofi acquired all outstanding common shares of Vigil for $8.00 per share in
cash at closing. Based on $8.00 per share, the total equity value of Vigil represents approximately $470 million (on a fully diluted
basis).
On May 27, 2025, Sanofi announced the completion of its acquisition of 100% of Dren-0201, Inc., a subsidiary of the privately held
clinical-stage biopharmaceutical company Dren Bio, Inc. (Dren Bio), further to a definitive agreement signed on March 19, 2025.
The acquired entity owns DR-0201, a targeted bispecific antibody developed by Dren Bio. DR-0201, now designated SAR448501,
engages myeloid cells for robust B-cell depletion, as demonstrated in preclinical and early-stage clinical study data. Sanofi
acquired Dren-0201, Inc. for an upfront payment of €539 million, supplemented by potential milestone payments of up to
€1.2 billion subject to the achievement of development and commercialization objectives.
On July 18, 2025, Sanofi announced the completion of its acquisition of Blueprint Medicines Corporation (Blueprint). The
acquisition adds a market-available medicine, Ayvakit/Ayvakyt (avapritinib), to Sanofi’s portfolio along with a promising pipeline,
and specialist expertise in the rare immune system disorder systemic mastocytosis (SM) and other diseases associated with the
KIT gene. The acquisition includes elenestinib, a next-generation medicine for SM, as well as BLU-808, a highly potent and
selective oral wild-type KIT inhibitor that has the potential to treat a broad range of diseases in immunology. Under the terms of
the acquisition, Sanofi paid $129.00 per share in cash at closing, representing an equity value of approximately $9.1 billion on a
fully diluted basis. Blueprint shareholders also received one non-tradeable and non-transferable contractual contingent value
right (CVR) per share, which entitles the holders thereof to receive two potential milestone payments of $2.00 and $4.00 per
CVR on the attainment of future development and regulatory milestones within the applicable milestone period, respectively, for
SAR449028 (formely known as BLU-808). The total equity value of the transaction, including potential CVR payments,
represented approximately $9.5 billion on a fully diluted basis. With the acquisition of Blueprint, Sanofi gained an established
presence among allergists, dermatologists, and immunologists, which is expected to strengthen our ability to advance our rapidly
growing immunology pipeline.
On July 22, 2025, Sanofi announced the signing of a definitive agreement to acquire Vicebio Ltd (Vicebio), a privately held
biotechnology company based in London, UK, specializing in the development of next-generation respiratory vaccines. Under
the terms of the agreement, Sanofi was to acquire all of Vicebio’s outstanding shares for an upfront payment of $1.15 billion,
supplemented by potential milestone payments of up to $450 million, contingent upon the achievement of development and
regulatory objectives. This acquisition provides Sanofi with an early-stage combination vaccine candidate against respiratory
syncytial virus (RSV) and human metapneumovirus (hMPV), as well as innovative molecular clamp technology, which enables the
quicker development of fully liquid combination vaccines that can be stored at standard refrigeration temperatures (2-8°C). After
obtaining all necessary regulatory approvals, the acquisition was consummated on December 4, 2025.
On September 24, 2025, Sanofi Ventures announced an additional $625 million multi-year capital commitment from Sanofi,
increasing its total assets under management to over $1.4 billion. This new commitment to the evergreen venture fund builds on
more than a decade of investing in innovative biotech and digital health companies that align with Sanofi’s long-term growth
ambitions.
On October 28, 2025, Sanofi announced that it had successfully placed its $3 billion bond issue across five tranches, including
fixed and floating rate notes maturing between November 2027 and November 2032, with interest rates ranging from 3.75% to
4.20%. The notes were issued under Sanofi’s shelf registration statement filed with the SEC on April 4, 2024, and the net
proceeds will be used for general corporate purposes.
On December 19, 2025, Sanofi entered into an agreement with the US government aimed at reducing the cost of medications for
American patients while strengthening the US role in bioproduction and pharmaceutical innovation. This voluntary and
confidential agreement addresses the four requests made by President Trump in letters sent to pharmaceutical manufacturers on
July 31, 2025. Specifically, Sanofi commits to aligning the Medicaid prices of certain medications with those in other high-income
countries, expected to result in an average reduction of 61% for certain treatments (for diabetes, cardiovascular diseases,
neurological diseases, and cancer). Sanofi will also offer direct access to patients through TrumpRx.gov with potential savings of
up to 70%. In return, Sanofi is receiving a three-year period free from Section 232 tariffs on products imported by Sanofi into the
US, while reaffirming its $20 billion investment in its US manufacturing capabilities. This agreement is expected to have no
material impact on Sanofi's growth strategy or financial outlook during the period covered.
On December 24, 2025, Sanofi announced that it had entered into an agreement to acquire Dynavax Technologies Corporation
(Dynavax), a publicly traded vaccines company with (i) a marketed adult hepatitis B vaccine (HEPLISAV-B), currently marketed in
the US, and (ii) a differentiated shingles vaccine candidate (Z-1018), currently in Phase 1/2 clinical development. Under the terms
of the merger agreement, Sanofi will commence a cash tender offer to acquire all outstanding shares of Dynavax for $15.50 per
share in cash, reflecting a total equity value of approximately $2.2 billion. Subject to the satisfaction or waiver of customary
closing conditions, the acquisition is expected to close in the first quarter of 2026.
(1)Non-IFRS financial measure: see definition in “— A.1.6. Presentation of net sales” below.
(2)Non-IFRS financial measure: see definition in “— A.1.5. Segment information and net income — 3/ Business net income” below.
60 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 5. Operating and Financial Review and Prospects |
2025 Financial results
For further information about the biopharma products we sell, and about our research and development portfolio, refer
to “Item 4. Information on the Company — B. Business Overview.”
Our net sales for 2025 amounted to €43,626 million, an increase of 6.2% from 2024. At constant exchange rates (CER)(1), net sales
rose by 9.9%, driven mainly by strong performances for Dupixent and increased sales of ALTUVIIIO.
Net income attributable to equity holders of Sanofi amounted to €7,813 million for 2025, compared with €5,560 million in
2024, a €2,253 million increase. Earnings per share was €6.40 in 2025, compared with €4.44 in 2024. Business net income(2)
was €9,555 million, up 7.2% on 2024, while business earnings per share (Business EPS(2)) was 10.0% higher than in 2024 at €7.83.
At the Annual General Meeting on April 29, 2026, we will ask our shareholders to approve a dividend of €4.12 per share for the
2025 financial year, representing a payout of 52.6% of our business net income per share (see “— B.2. Consolidated balance
sheet and debt.”).
A.1.2. Impacts of competition from generics and biosimilars
Some of our flagship products continued to suffer sales erosion in 2025 under the impact of competition from generics and
biosimilars. We do not believe it is possible to state with certainty what level of net sales would have been achieved in the
absence of generic competition. A comparison of our consolidated net sales for the years ended December 31, 2025 and 2024
(see “— A.2. Results of Operations — Year Ended December 31, 2025 Compared with Year Ended December 31, 2024” below)
for the main products affected by generic and biosimilar competition shows a year-on-year loss of €353 million of net sales on
a reported basis. However, other parameters can also contribute to the loss of sales, such as a fall in the average selling price of
certain products.
The table below sets forth the change by product.
(€ million) | 2025 | 2024 | Change on a reported basis | Change on a reported basis (%) |
Aprovel Europe | 71 | 73 | (2) | -2.7% |
Lantus Europe | 297 | 340 | (43) | -12.6% |
Lovenox Europe | 455 | 567 | (112) | -19.8% |
Plavix Europe | 88 | 91 | (3) | -3.3% |
Aubagio Europe | 67 | 152 | (85) | -55.9% |
Mozobil Europe | 8 | 39 | (31) | -79.5% |
Aubagio United States | 135 | 187 | (52) | -27.8% |
Mozobil United States | 4 | 12 | (8) | -66.7% |
Aprovel Japan | 5 | 11 | (6) | -54.5% |
Plavix Japan | 11 | 22 | (11) | -50.0% |
Total | 1,141 | 1,494 | (353) | -23.6% |
We expect the erosion caused by generic competition to continue in 2026, with a negative impact on our net income. The
products likely to be impacted in 2026 include those that already faced generic competition in 2025, but whose sales can
reasonably be expected to be subject to further sales erosion in 2026 (see products listed in the table above). In addition, we
have experienced generic competition for Aubagio in the US since March 2023 and in Europe since October 2023, with an
intensification since 2024. The same pattern occurred for Mozobil with generic competition in the US since July 2023, and in
Europe since early 2024.
In 2025, aggregate consolidated net sales of those products in Europe, the US and Japan were €1,141 million; this comprised
€986 million in Europe, €139 million in the US and €16 million in Japan. The negative impact on our 2026 net sales is likely to
represent a substantial portion of those sales, but the actual impact will depend on a number of factors, such as the impact of
generics and biosimilars on sales of our molecules, but also the market entry of generics of other molecules that are in
competition with our products.
In China, the authorities have implemented a range of healthcare cost containment measures, including the Volume Based
Procurement (VBP) reverse auction that particularly impacts our insulin-based products, Plavix, Aprovel, and Lovenox (see also
“Item 4. Information on the Company — B. Business Overview — B.5.4. Pricing & Reimbursement”). A large number of molecules
were selected to submit tenders under successive waves of the VBP program, with the successful bidders being awarded a high
level of market share in return for offering lower prices. The recent eleventh round of VBP results remained very unfavorable to
multinational companies. Domestic generic companies confirmed the existing trend, and won the main bids due to further
aggressive price reductions.
(1)From 2024, Net sales excludes sales of Consumer Healthcare products, reclassified within Net income from discontinued operations for the years
presented.
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ITEM 5. Operating and Financial Review and Prospects |
A.1.3. Purchase accounting effects
Our results of operations and financial condition for the years ended December 31, 2025 and 2024, have been significantly
affected by our past acquisitions. See “— A.1.11. Critical accounting and reporting policies — 2/ Business combinations” below for
an explanation of the impact of business combinations on our results of operations.
Significant amortization of intangible assets has been generated by the following business combinations: Blueprint (€255 million
in 2025); Genzyme (€51 million in 2025 and €152 million in 2024); Bioverativ (€590 million in 2025 and €630 million in 2024);
Kadmon (€157 million in 2025 and €164 million in 2024); and Provention (€205 million in 2025 and €214 million in 2024).
In order to isolate the purchase accounting effects of all acquisitions and the impact of certain other items, we use a non-IFRS
financial measure that we refer to as “Business net income” (see definition and discussion of reconciliation to the IFRS financial
measure Net income attributable to equity holders of Sanofi in “— A.1.5. Segment Information and Business Net Income —
3/ Business Net Income” below).
A.1.4. Sources of revenues and expenses
Revenues: Revenue arising from the sale of goods is presented in the income statement within Net sales. Net sales comprise
revenue from sales of medicines, vaccines and active ingredients (1), net of sales returns, of customer incentives and discounts,
and of certain sales-based payments paid or payable to the healthcare authorities. Returns, discounts, incentives and rebates are
recognized in the period in which the underlying sales are recognized, as a reduction of sales revenue. See Note B.13.1. to our
consolidated financial statements included at Item 18. of this annual report. We sell biopharma products directly, through
alliances, and by licensing arrangements throughout the world. When we sell products directly, we record sales revenues as part
of our consolidated net sales. When we sell products through alliances, the revenues reflected in our consolidated financial
statements are based on the contractual arrangements governing those alliances. For more information about our alliances,
see “— A.1.7. Financial Presentation of Alliances” below.
Other revenues: all revenue that falls within the scope of IFRS 15 but does not relate to sales of Sanofi products is shown in this
line item. It mainly comprises (i) royalties received from licensing intellectual property rights to third parties; (ii) VaxServe sales of
products sourced from third-party manufacturers; and (iii) revenue received under agreements for Sanofi to provide
manufacturing services to third parties. Royalties received under licensing arrangements are recognized over the period during
which the underlying sales are recognized. VaxServe's operations include the distribution within the US of vaccines and other
products manufactured by third parties.
Other revenues is also used to recognize revenues generated from the manufacturing of Consumer Healthcare products on
behalf of Opella entities. Until April 30, 2025, Opella entities were within the scope of discontinued operations (see Note B.7. to
our consolidated financial statements included at Item 18. of this annual report). With effect from May 1, 2025, Opella entities are
treated as related parties in accordance with IAS 24 (see Note D.6. to our consolidated financial statements included at Item 18.
of this annual report).
In addition, Other revenues includes revenues associated with Consumer Healthcare operations not transferred on the effective
date of loss of control of Opella. These comprise primarily, but not exclusively, Consumer Healthcare activities that were not
transferred on the effective date of loss of control of Opella, primarily (i) hospital sales of Opella products in China, the transfer of
which will be finalized no earlier than 2028 after a transitional period required to complete the transfer plan agreed with Sanofi in
the context of public tendering arrangements; (ii) sales made by the dedicated entity Opella Russie, of which Sanofi continues to
hold the capital (Sanofi is continuing to distribute Opella products in Russian territory under a distribution agreement signed in
connection with the separation, the parties reserving the right to discuss the transfer of that entity during the term of the
distribution agreement); and (iii) sales of the Gold Bond product range, which are continuing in the US through the retained
subsidiary Gold Bond LLC (holder of the associated worldwide property rights).
Cost of Sales. Our cost of sales consists primarily of the cost of purchasing raw materials and active ingredients, labor and other
costs relating to our manufacturing activities, packaging materials, payments made under licensing agreements and distribution
costs. We have license agreements under which we manufacture, sell and distribute products that are patented by other
companies. When we pay royalties, we record them in Cost of sales.
Operating Income. Our operating income reflects our revenues, our cost of sales and the remainder of our operating expenses,
the most significant of which are research and development expenses and selling and general expenses. For our operating
segment, we also measure our results of operations through an indicator referred to as “Business Operating Income,” which we
describe below under “— A.1.5. Segment Information and Business Net Income — 2/ Business Operating Income.”
A.1.5. Segment information and Business net income
1/ Segment information
In accordance with IFRS 8 (Operating Segments), the segment information reported by Sanofi is prepared on the basis of internal
management data provided to our Chief Executive Officer, who is the chief operating decision maker of Sanofi. The operating
segment disclosures required under IFRS 8 are provided in Notes B.26. and D.35. to our consolidated financial statements
included at Item 18. of this annual report.
The segment information presented by Sanofi consists of a single operating segment: Biopharma.
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ITEM 5. Operating and Financial Review and Prospects |
The Biopharma operating segment comprises commercial operations and research, development and production activities
relating to the Specialty Care, General Medicines and Vaccines franchises plus support and corporate functions, for all
geographical territories. It also includes revenues generated from the manufacture of Consumer Healthcare products invoiced to
Opella Healthcare SAS (Opella), which constitutes a related party with effect from April 30, 2025, the deconsolidation date,
corresponding to the closing of Sanofi's sale of a controlling stake of approximately 50% in Opella to Clayton, Dubilier & Rice
(CD&R) (for more information, see “Item 4. Information on the Company — B. Business overview — B.3 Opella”). Those revenues,
which before the deconsolidation date represented intragroup transactions classified within continuing operations, are
presented within Other revenues in the income statement. The Biopharma operating segment also includes the purchase price
of Biopharma products manufactured by Opella.
The “Other” category comprises primarily, but not exclusively, Consumer Healthcare activities not transferred on the effective
date of loss of control of Opella. These are primarily (i) hospital sales of Opella products in China, the transfer of which will be
finalized no earlier than 2028; (ii) sales made by the dedicated entity Opella Russie, of which Sanofi continues to hold the capital
(Sanofi is continuing to distribute Opella products in Russian territory under a distribution agreement signed in connection with
the separation, the parties reserving the right to discuss the transfer of that entity during the term of the distribution agreement);
and (iii) sales of the Gold Bond product range, which are continuing in the United States through the retained subsidiary Gold
Bond LLC (holder of the associated worldwide property rights).
2/ Business operating income (non-IFRS financial measure)
We report segment results on the basis of “Business operating income.” This non-IFRS indicator is used internally by Sanofi’s chief
operating decision maker to measure the performance of our operating segment and to allocate resources. For a definition of
“Business operating income”refer to Note D.35. to our consolidated financial statements included at Item 18. of this annual report.
“Business operating income” is a non-IFRS financial measure and is reconciled with IFRS Operating income. In 2025, Operating
income amounted to €6,344 million, versus €7,252 million for 2024, and our “Business operating income” amounted to
€12,149 million, versus €11,343 million in 2024. The reconciliation between these two measures is presented in the table below.
Because our “Business operating income” is not a standardized measure, it may not be directly comparable with the non-IFRS
financial measures of other companies using the same or similar non-IFRS financial measures. Although management uses this
non-IFRS measure to set goals and measure performance, it has no standardized meaning prescribed by IFRS. This non-IFRS
measure is presented solely to permit investors to more fully understand how Sanofi’s management assesses underlying
performance. This non-IFRS measure is not, and should not be viewed as, a substitute for IFRS measures, and should be viewed in
conjunction with IFRS measures of our performance and financial position. Consequently, there may be limitations on the
usefulness of this measure to investors.
(€ million) | 2025 | 2024 |
Operating income (IFRS) | 6,344 | 7,252 |
Other gains and losses, and litigation(a) | 255 | 470 |
Restructuring costs and similar items(b) | 1,138 | 1,396 |
Expenses arising from the impact of acquisitions on inventories(c) | 126 | 10 |
Fair value remeasurement of contingent consideration | 104 | 96 |
Impairment of intangible assets(d) | 2,241 | 248 |
Amortization of intangible assets | 1,776 | 1,749 |
Net income attributable to non-controlling interests(e) | (14) | (14) |
Share of profit/(loss) from investments accounted for using the equity method(f) | 179 | 136 |
Business operating income (non-IFRS) | 12,149 | 11,343 |
(a)See Note D.28. to our consolidated financial statements included at Item 18. of this annual report.
(b) See Note D.27. to our consolidated financial statements included at Item 18. of this annual report.
(c)This line records the impact of the workdown of acquired inventories remeasured at fair value at the acquisition date, which in 2025 relates to the
Blueprint Medicines acquisition (see Note D.1.).
(d)For 2025, this line mainly comprises a €1,663 million impairment loss recognized on tolebrutinib, a drug candidate in the registration phase targeting
multiple sclerosis, reflecting the reduced probability of approval arising from the negative PERSEUS phase 3 study results in Primary Progressive Multiple
Sclerosis (PPMS) and recent exchanges with the FDA and EMA on Secondary Progressive Multiple Sclerosis (SPMS). For 2024, this line includes a net
impairment charge of €248 million, mainly due to (i) recognition of impairment losses of €640 million against various research and development projects
(including a €239 million loss resulting from the decision taken in February 2025 to discontinue a Phase 3 clinical study investigating a vaccine
candidate to prevent invasive E.coli disease), partially offset by (ii) impairment loss reversals recognized in connection with the disposals of the ProXTen
platform and Enjaymo, for €225 million and €167 million respectively.
(e)Excludes (i) restructuring costs and (ii) other adjustments attributable to non-controlling interests.
(f)Mainly joint ventures.
3/ Business net income (non-IFRS financial measure)
Sanofi also presents “Business net income”, a non-IFRS financial measure that is not included in our primary financial statements.
The IFRS measure most directly comparable to “Business net income” is Net income attributable to equity holders of Sanofi,
which amounted to €7,813 million for 2025, versus €5,560 million for 2024, representing an increase of 40.5%. “Business net
income” amounted to €9,555 million for 2025 versus €8,912 million for 2024, representing an increase of 7.2%. “Business net
income” for 2025 represents 21.9% of our net sales, compared with 21.7% in 2024.
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ITEM 5. Operating and Financial Review and Prospects |
The table below reconciles Net income attributable to equity holders of Sanofi to our “Business net income”:
(€ million) | 2025 | 2024 |
Net income attributable to equity holders of Sanofi (IFRS) | 7,813 | 5,560 |
Net income from the discontinued Opella business(a) | (2,874) | (64) |
Amortization of intangible assets | 1,776 | 1,749 |
Impairment of intangible assets(b) | 2,241 | 248 |
Fair value remeasurement of contingent consideration(c) | 118 | 127 |
Expenses arising from the impact of acquisitions on inventories | 126 | 10 |
Restructuring costs and similar items | 1,138 | 1,396 |
Other gains and losses, and litigation | 255 | 470 |
Financial (income)/expenses relating to financial liabilities accounted for at amortized cost and subject to periodic remeasurement (d) | (93) | 291 |
Tax effects of the items listed above: | (1,311) | (883) |
•amortization and impairment of intangible assets | (888) | (359) |
•fair value remeasurement of contingent consideration | (27) | (25) |
•expenses arising from the impact of acquisitions on inventories | (35) | — |
•restructuring costs and similar items | (252) | (320) |
•other items | (109) | (179) |
Other tax effects | 22 | (81) |
Other items(e) | 344 | 89 |
Business net income (non-IFRS) | 9,555 | 8,912 |
Average number of shares outstanding (million) | 1,220.4 | 1,251.4 |
Basic earnings per share (IFRS) (€) | 6.40 | 4.44 |
Reconciling items per share (€)(f) | 1.43 | 2.68 |
Business earnings per share (non-IFRS) (€) | 7.83 | 7.12 |
(a)In 2025, this line includes €2.6 billion related to the net gain on the Opella divestment, recognized on the date of loss of control (refer to Note D.1.).
(b) For 2025, this line mainly comprises a €1,663 million impairment loss recognized on tolebrutinib, a drug candidate in the registration phase targeting
multiple sclerosis, reflecting the reduced probability of approval arising from the negative PERSEUS phase 3 study results and recent exchanges with
the FDA and EMA. For 2024, this line includes a net impairment charge of €248 million, mainly due to (i) recognition of impairment losses of €640 million
against various research and development projects (including a €239 million loss resulting from the decision taken in February 2025 to discontinue a
Phase 3 clinical study investigating a vaccine candidate to prevent invasive E.coli disease), partially offset by (ii) impairment loss reversals recognized in
connection with the disposals of the ProXTen platform and Enjaymo, for €225 million and €167 million respectively.
(c)This line includes an impact attributable to non-controlling interests, related to a remeasurement of contingent consideration within a subsidiary of
Sanofi: €14 million expense in 2025 and €31 million expense in 2024.
(d)This line corresponds to the financial expense arising from remeasurement of the financial liability recognized in the balance sheet to reflect estimated
future royalties on sales of Beyfortus in the US.
(e)In 2025, this line includes the €310 million share of the losses of the associate OPAL JV Co (accounted for under the equity method since May 1, 2025,
see Note D.1.) attributable to the equity holders of Sanofi; that amount includes the effects of the purchase price allocation, and of related fair value
adjustments to the identifiable assets and liabilities (mainly intangible assets and inventories). This line also includes the share of profits/losses arising
from the equity-accounted investment in EUROAPI, including an impairment loss taken against the equity interests based on the quoted market price:
€2.27 as of December 31, 2025 and €2.88 as of December 31, 2024.
(f)Corresponds to the reconciliation between basic earnings per share (IFRS) and business earnings per share (non-IFRS): sum total of reconciling items
divided by the weighted average number of shares outstanding.
We define “Business net income” as Net income attributable to equity holders of Sanofi determined under IFRS, excluding the
following items:
•net income from discontinued operations, including Opella;
•amortization and impairment losses charged against intangible assets (other than software and other rights of an industrial or
operational nature);
•fair value remeasurements of contingent consideration relating to business combinations (IFRS 3), or to divestments of
operations meeting the definition of a business;
•expenses arising from the remeasurement of inventories following business combinations (IFRS 3) or acquisitions of groups of
assets that do not constitute a business within the meaning of paragraph 2b of IFRS 3;
•restructuring costs and similar items (presented within the line item Restructuring costs and similar items);
•other gains and losses (including gains and losses on major divestments), presented within the line item Other gains and
losses, and litigation;
•other costs and provisions related to litigation (presented within the line item Other gains and losses, and litigation);
•(income)/expenses related to financial liabilities accounted for at amortized cost and subject to periodic remeasurement in
accordance with paragraph B5.4.6 of IFRS 9 (Financial Instruments);
•tax effects related to the items listed above as well as effects of major tax disputes;
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ITEM 5. Operating and Financial Review and Prospects |
•the share of profits/losses from investments accounted for using the equity method, except for the share of profits/losses
from investments accounted for using the equity method, to the extent that this relates (i) to joint ventures or (ii) to associates
with which Sanofi has entered into R&D agreements and/or whose operations are managed as an integral part of Sanofi’s
business activities; and
•the portion attributable to non-controlling interests of the items listed above.
We also report “Business earnings per share” (“Business EPS”), a non-IFRS financial measure we define as “Business net income”
divided by the weighted average number of shares outstanding. “Business EPS” was €7.83 for 2025, compared with €7.12 for
2024 (up 10.0%), based on an average number of shares outstanding of 1,220.4 million for 2025 and 1,251.4 million for 2024.
The most significant reconciling items between “Business net income” and Net income attributable to equity holders of Sanofi
relate to (i) the purchase accounting effects of our acquisitions of groups of assets and business combinations, particularly the
amortization and impairment of intangible assets (other than software and other rights of an industrial or operational nature);
(ii) the impacts of restructuring actions or transactions regarded as non-recurring, where the amounts involved are particularly
significant; (iii) remeasurements recognized through profit or loss in respect of (a) amounts receivable in respect of business
divestments and accounted for at fair value, (b) liabilities arising from business combinations (IFRS 3) and accounted for at fair
value, and (c) liabilities accounted for at amortized cost and subject to periodic remeasurement under IFRS 9; and (iv) net income
from discontinued operations, including Opella. We believe that excluding those impacts enhances an investor’s understanding
of our underlying economic performance, because it gives a better representation of our recurring operating performance.
We believe that eliminating charges related to purchase accounting effects (particularly amortization and impairment of some
intangible assets) enhances comparability of our ongoing operating performance relative to our peers. Those intangible assets
(principally rights relating to research and development, technology platforms and commercialization of products) are accounted
for in accordance with IAS 38 (Intangible Assets) and IFRS 3 (Business Combinations).
We also believe that eliminating the other effects of business combinations (such as the incremental cost of sales arising from the
workdown of acquired inventories remeasured at fair value in business combinations) gives a better understanding of our
recurring operating performance.
Eliminating restructuring costs and similar items enhances comparability with our peers because those costs are incurred in
connection with reorganization and transformation of Sanofi's programs, integration or separation as part of material deals.
We believe that eliminating the effects of transactions that we regard as non-recurring and that involve particularly significant
amounts (such as major gains and losses on disposals, and costs and provisions associated with major litigation and other major
non-recurring items) improves comparability from one period to the next.
Finally, remeasurements recognized in profit or loss during the period in respect of (i) assets or liabilities accounted for at fair
value and recognized in the balance sheet in connection with business acquisitions or divestments or (ii) liabilities accounted for
at amortized cost and subject to periodic remeasurement, generally determined on the basis of revised sales forecasts, are not
reflective of our operating performance.
In addition, “Business net income” excludes net income from the Opella discontinued operation, the results of which have been
presented separately in the consolidated income statement since October 2024. Under IFRS 5 (Non-Current Assets Held for Sale
and Discontinued Operations), a discontinued operation is defined as a component of an entity that has been disposed of or is
classified as held for sale, and represents a separate major line of business. With effect from October 2024, “Business net income”
from continuing operations is used by management to measure Sanofi’s financial performance on an ongoing basis. We believe
that providing a performance measure aligned with our management approach is useful for investors and analysts.
We remind investors, however, that “Business net income” should not be considered in isolation from, or as a substitute for, Net
income attributable to equity holders of Sanofi reported in accordance with IFRS. In addition, we strongly encourage investors
and potential investors not to rely on any single financial measure but to review our financial statements, including the notes
thereto, carefully and in their entirety.
We compensate for the material limitations described above by using “Business net income” only to supplement our IFRS
financial reporting and by ensuring that our disclosures provide sufficient information for a full understanding of all adjustments
included in “Business net income.”
Because our “Business net income” and “Business EPS” are not standardized measures, they may not be directly comparable with
the non-IFRS financial measures of other companies using the same or similar non-IFRS financial measures.
A.1.6. Presentation of net sales
In the discussion below, we present our consolidated net sales for 2025 and 2024. We analyze our net sales by various categories
including medicines, vaccines, business, and geographical region. In addition to reported net sales, we analyze non-IFRS financial
measures designed to isolate the impact on our net sales of currency exchange rates and changes in the structure of our group.
When we refer to changes in our net sales at constant exchange rates (CER), that means that we have excluded the effect of
exchange rates by recalculating net sales for the relevant period using the exchange rates that were used for the previous period.
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A.1.7. Financial presentation of alliances
We have entered into a number of alliances for the development, co-promotion and/or co-marketing of our products. The two
principal alliances are with Regeneron Pharmaceuticals, Inc. for the development and commercialization of therapeutic
antibodies including Dupixent and Kevzara, and with AstraZeneca for the development and commercialization of Beyfortus
(nirsevimab) for RSV prevention.
Specifically with respect to Regeneron, in 2014 and 2020, Sanofi and Regeneron amended the Investor Agreement entered into
by the two companies in 2007. Under the terms of the amendments, Sanofi accepted various restrictions, including “standstill”
provisions that contractually prohibit Sanofi from seeking to directly or indirectly exert control of Regeneron or acquiring more
than 30% of Regeneron’s capital stock (consisting of the outstanding shares of common stock and the shares of Class A stock).
This prohibition remains in place until the earlier of (i) the later of the fifth anniversaries of the expiration or earlier termination of
the Zaltrap collaboration agreement with Regeneron (related to the development and commercialization of Zaltrap) or the
collaboration agreement with Regeneron on monoclonal antibodies, each as amended or (ii) other specified events.
For detailed information on the terms, financial arrangements, and accounting treatment of these alliances, see Note C “Principal
alliances” to our consolidated financial statements included at Item 18. of this annual report.
A.1.8. Impact of exchange rates
We report our consolidated financial statements in euros. Because we earn a significant portion of our revenues in countries
where the euro is not the local currency, our results of operations can be significantly affected by exchange rate movements
between the euro and other currencies.
We experience these effects even though certain of these countries do not account for a large portion of our net sales. In 2025,
we earned 50.8% of our net sales in the United States. An increase in the value of the US dollar against the euro has a positive
impact on both our revenues and our operating income. A decrease in the value of the US dollar against the euro has a negative
impact on our revenues, which is not offset by an equal reduction in our costs and therefore negatively affects our operating
income. A variation in the value of the US dollar has a particularly significant impact on our operating income, which is higher in
the United States than elsewhere.
For a description of arrangements entered into to manage operating foreign exchange risks as well as our hedging policy,
see “Item 11. Quantitative and Qualitative Disclosures about Market Risk,” and “Item 3. Key Information — D. Risk Factors — Risks
Related to Financial Markets — Fluctuations in currency exchange rates could adversely affect our results of operations and
financial condition.”
A.1.9. Divestments
On April 30, 2025, Sanofi and CD&R closed the Opella Transaction following the signature of the share purchase agreement (SPA)
on February 18, 2025. The Opella Transaction generated a net cash inflow of €10.4 billion, presented within the line item Net cash
inflow from the Opella transaction in the statement of cash flows. For more information on the Opella Transaction, see "— A.1.1.
2025 Overview" and Note D.1.1.1. to our consolidated financial statements included at Item 18 of this annual report.
On November 29, 2024, Sanofi entered into a definitive agreement with Recordati for the sale of Sanofi's global rights to Enjaymo
and the transfer of specific employees. Under this agreement, Sanofi received an upfront payment of $825 million and will be
eligible for milestone payments of up to $250 million based on sales.
For further details about the divestments mentioned above, see Note D.1. to our consolidated financial statements included
at Item 18. of this annual report.
A.1.10. Acquisitions
In the year ended December 31, 2025, Sanofi:
•entered into an agreement to acquire Dynavax; and
•completed the acquisitions of Vicebio, Blueprint, DR-0201 and Vigil.
For further information about these acquisitions see “— A.1.1. 2025 Overview” and Note D.1. to our consolidated financial
statements included at Item 18. of this annual report.
In the year ended December 31, 2024, Sanofi completed the acquisition of Inhibrx, adding SAR447537 (formerly INBRX-101) to
Sanofi’s rare disease pipeline. The impact of this acquisition, as reflected within the line item Acquisitions of consolidated
undertakings and investments accounted for using the equity method in the consolidated statement of cash flows, is a net
cash outflow of $2,035 million.
For further information about the Inhibrx acquisition, see “Item 4. Information on the Company – A. History and development of
the Company” and Note D.1. to our consolidated financial statements included at Item 18. of this annual report.
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A.1.11. Critical accounting and reporting policies
Our consolidated financial statements are affected by the accounting and reporting policies that we use. Certain of our
accounting and reporting policies are critical to an understanding of our results of operations and financial condition, and in some
cases the application of these critical policies can be significantly affected by the estimates, judgments and assumptions made
by management during the preparation of our consolidated financial statements. The accounting and reporting policies that we
have identified as critical to a full understanding of our results of operations and financial condition are the following:
1/ Revenue recognition
Our policies with respect to revenue recognition are discussed in Note B.13. to our consolidated financial statements included
at Item 18. of this annual report. Revenue arising from the sale of goods is presented in the income statement within Net sales.
Net sales comprise revenue from sales of medicines, vaccines, and active ingredients, net of sales returns, of customer incentives
and discounts, and of certain sales-based payments paid or payable to the healthcare authorities. In accordance with IFRS 15
(Revenue from Contracts with Customers), such revenue is recognized when Sanofi transfers control over the product to the
customer. Control refers to the ability to direct the use of, and obtain substantially all of the remaining benefits from, the
products. For the vast majority of contracts, revenue is recognized when the product is physically transferred, in accordance with
the delivery and acceptance terms agreed with the customer.
For contracts entered into by our vaccines business, transfer of control is usually determined by reference to the terms of release
(immediate or deferred) and acceptance of batches of vaccine.
As regards contracts with distributors, Sanofi does not recognize revenue when the product is physically transferred to the
distributor in case of products sold on consignment, or if the distributor acts as an agent. In such cases, revenue is recognized
when control is transferred to the end customer, and the distributor’s commission is presented within the line item Selling and
general expenses in the income statement.
We offer various types of price reductions on our products. In particular, products sold in the US are covered by various programs
(such as Medicare and Medicaid) under which products are sold at a discount. Rebates are granted to healthcare authorities, and
under contractual arrangements with certain customers. For more information on price reductions of our products, see “Item 4.
Information on the Company — B. Business Overview — B.5.4. Pricing & Reimbursement.” Some wholesalers are entitled to
chargeback incentives based on the selling price to the end customer, under specific contractual arrangements. Cash discounts
may also be granted for prompt payment. The discounts, incentives and rebates described above are estimated on the basis of
specific contractual arrangements with our customers or of specific terms of the relevant regulations and/or agreements
applicable for transactions with healthcare authorities, and of assumptions about the attainment of sales targets. We also
estimate the amount of sales returns, on the basis of contractual sales terms and reliable historical data. Discounts, incentives,
rebates and sales returns are recognized in the period in which the underlying sales are recognized within Net Sales, as a
reduction of gross sales. For additional details regarding the financial impact of discounts, incentives, rebates and sales returns,
see Note D.23. to our consolidated financial statements included at Item 18. of this annual report.
Revenues from non-Sanofi products, mainly comprising royalty income from license arrangements and sales of non-Sanofi
products by our US-based entity VaxServe, are presented within Other revenues. This line item also includes revenues arising
from the distribution of Eloctate and Alprolix under Sanofi’s agreements with Swedish Orphan Biovitrum AB (Sobi) and revenue
received under agreements for Sanofi to provide manufacturing services to third parties. Other revenues is also used to recognize
revenues generated from the manufacturing of Consumer Healthcare products on behalf of Opella entities. Until April 30, 2025,
Opella entities were within the scope of discontinued operations (see Note B.7. to our consolidated financial statements included
at Item 18. of this annual report). With effect from May 1, 2025, Opella entities are treated as related parties in accordance with
IAS 24 (see Note D.6. to our consolidated financial statements included at Item 18. of this annual report). In addition, Other
revenues includes revenues associated with Consumer Healthcare operations not transferred on the effective date of loss of
control of Opella. These comprise primarily, but not exclusively, Consumer Healthcare activities that were not transferred on the
effective date of loss of control of Opella, primarily (i) hospital sales of Opella products in China, the transfer of which will be
finalized no earlier than 2028 after a transitional period required to complete the transfer plan agreed with Sanofi in the context
of public tendering arrangements; (ii) sales made by the dedicated entity Opella Russie, of which Sanofi continues to hold the
capital (Sanofi is continuing to distribute Opella products in Russian territory under a distribution agreement signed in connection
with the separation, the parties reserving the right to discuss the transfer of that entity during the term of the distribution
agreement); and (iii) sales of the Gold Bond product range, which are continuing in the US through the retained subsidiary Gold
Bond LLC (holder of the associated worldwide property rights). Finally, in the interests of consistency, Other revenues includes
revenues associated with Consumer Healthcare operations that will not be transferred on the effective date of loss of control of
Opella. For further discussion of the Other revenues line item, see “— A.1.4. Sources of revenues and expenses.”
SANOFI FORM 20-F 2025 | 67 |
PART I |
ITEM 5. Operating and Financial Review and Prospects |
2/ Business combinations
As discussed in Note B.3. “Business combinations and transactions with non-controlling interests” to our consolidated financial
statements included at Item 18. of this annual report, business combinations are accounted for by the acquisition method.
The acquiree’s identifiable assets and liabilities that satisfy the recognition criteria of IFRS 3 (Business Combinations) are
measured initially at their fair values as at the acquisition date, except for (i) non-current assets classified as held for sale, which
are measured at fair value less costs to sell and (ii) assets and liabilities that fall within the scope of IAS 12 (Income Taxes)
and IAS 19 (Employee Benefits). Business combinations completed on or after January 1, 2010 are accounted for in accordance
with the revised IFRS 3 and IFRS 10 (Consolidated Financial Statements). In particular, contingent consideration payable to former
owners agreed in a business combination, e.g. in the form of payments upon the achievement of certain R&D milestones, is
recognized as a liability at fair value as of the acquisition date irrespective of the probability of payment. If the contingent
consideration was originally recognized as a liability, subsequent adjustments to the liability are recognized in profit or loss
(see Note D.18. to our consolidated financial statements included at Item 18. of this annual report).
3/ Impairment of goodwill and intangible assets
As discussed in Note B.6. “Impairment of property, plant and equipment, intangible assets, and investments accounted for using
the equity method” and in Note D.5. “Impairment of intangible assets and property, plant and equipment” to our consolidated
financial statements included at Item 18. of this annual report, we test our intangible assets for impairment periodically or when
there is any internal or external indication of impairment. Such indicators could include primarily but not exclusively (i) increased
market competition resulting from (for example) the introduction of a competitor’s product; (ii) earlier than expected loss of
exclusivity; (iii) increased pricing pressure; (iv) restrictions imposed by regulatory authorities on the manufacture or sale of a
product; (v) delay in the projected launch of a product; (vi) different from expected clinical study results; (vii) higher than
expected development costs or (viii) lower than expected economic performance.
We test for impairment on the basis of the same objective criteria that were used for the initial valuation. Our initial valuation and
ongoing tests are based on the relationship of the value of our projected future cash flows associated with the asset to either the
purchase price of the asset (for its initial valuation) or the carrying amount of the asset (for ongoing tests for impairment).
Significant underlying assumptions requiring the exercise of considerable judgement are applied in the future cash flow
projections used to determine the recoverability of intangible assets, including primarily but not exclusively (i) therapeutic class
market growth drivers; (ii) expected impacts from competing products (including but not exclusively generics and biosimilars);
(iii) projected pricing and operating margin levels; (iv) likely changes in the regulatory, legal or tax environment; and
(v) management’s estimates of terminal growth or attrition rates.
The recoverable amounts of intangible assets related to research and development projects are determined based on future net
cash flows, which reflect the development stage of the project and the associated probability of success of marketization of the
compound.
The projected cash flows are discounted to present value using a discount rate, which factors in the risks inherent in cash flow
projections.
Changes in facts and circumstances, assumptions and/or estimates may lead to future additional impairment losses or reversal of
impairment previously recorded.
Key assumptions relating to goodwill impairment are the perpetual growth rate, the post-tax discount rate, and operating margin.
A sensitivity analysis to the key assumptions is disclosed in Note D.5. “Impairment of intangible assets and property, plant and
equipment” to our consolidated financial statements included at Item 18. of this annual report.
4/ Pensions and post-retirement benefits
As described in Note B.23. “Employee benefit obligations” to our consolidated financial statements included at Item 18. of this
annual report, we recognize our pension and retirement benefit commitments as liabilities on the basis of an actuarial estimate of
the rights vested in employees and retirees at the end of the reporting period, net of the fair value of plan assets held to meet
those obligations. We prepare this estimate at least on an annual basis taking into account financial assumptions (such as
discount rates) and demographic assumptions (such as life expectancy, retirement age, employee turnover, and the rate of salary
increases).
We recognize all actuarial gains and losses (including the impact of a change in discount rate) immediately through equity.
Depending on the key assumptions used, the pension and post-retirement benefit expense could vary within a range of
outcomes and have a material effect on reported earnings. A sensitivity analysis to these key assumptions is set forth
in Note D.19.1. “Provisions for pensions and other benefits” to our consolidated financial statements included at Item 18. of this
annual report.
68 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 5. Operating and Financial Review and Prospects |
5/ Taxes
As discussed in Note B.22. “Income tax expense” to our consolidated financial statements included at Item 18. of this annual
report, we recognize deferred income taxes on tax loss carry-forwards and on temporary differences between the tax base and
carrying amount of assets and liabilities. We calculate our deferred tax assets and liabilities using enacted tax rates applicable for
the years during which we estimate that the temporary differences are expected to reverse. We do not recognize deferred tax
assets when it is more likely than not that the deferred tax assets will not be realized. The recognition of deferred tax assets is
determined on the basis of profit forecasts for each tax group, and of the tax consequences of the strategic opportunities
available to Sanofi.
The positions adopted by Sanofi in tax matters are based on its interpretation of tax laws and regulations. Some of those positions
may be subject to uncertainty. In such cases, Sanofi assesses the amount of the tax liability on the basis of the following
assumptions: that its position will be examined by one or more tax authorities on the basis of all relevant information; that a
technical assessment is carried out with reference to legislation, case law, regulations, and established practice; and that each
position is assessed individually (or collectively where appropriate), with no offset or aggregation between positions. Those
assumptions are assessed on the basis of facts and circumstances existing at the end of the reporting period. When an uncertain
tax liability is regarded as probable, it is measured on the basis of Sanofi’s best estimate and recognized as a liability; uncertain tax
assets are not recognized.
6/ Provisions for risks
Sanofi and its subsidiaries and affiliates may be involved in litigation, arbitration or other legal proceedings. These proceedings
typically are related to product liability claims, intellectual property rights, compliance and trade practices, commercial claims,
employment and wrongful discharge claims, tax assessment claims, waste disposal and pollution claims, and claims under
warranties or indemnification arrangements relating to business divestitures. As discussed in Note B.12. “Provisions for risks” to
our consolidated financial statements included at Item 18. of this annual report, we record a provision where we have a present
obligation, whether legal or constructive, as a result of a past event; it is probable that an outflow of resources embodying
economic benefits will be required to settle the obligation; and a reliable estimate can be made of the amount of the outflow of
resources. We also disclose a contingent liability in circumstances where we are unable to make a reasonable estimate of the
expected financial effect that will result from the ultimate resolution of the proceeding, or a cash outflow is not probable.
For additional details regarding the financial impact of provisions for risks, see Notes D.19.3. “Other provisions” and D.22. “Legal
and Arbitral Proceedings” to our consolidated financial statements included at Item 18. of this annual report.
7/ Provisions for restructuring costs
Provisions for restructuring costs include collective redundancy or early retirement benefits, compensation for early termination
of contracts, and rationalization costs relating to restructured sites. Refer to Note D.19.2. to our consolidated financial statements
included at Item 18. of this annual report.
Provisions are estimated on the basis of events and circumstances related to present obligations at the end of the reporting
period and of past experience, and to the best of management’s knowledge at the date of preparation of the financial
statements. The assessment of provisions can involve a series of complex judgments about future events and can rely heavily on
estimates and assumptions. Given the inherent uncertainties related to these estimates and assumptions, the actual outflows
resulting from the realization of those risks could differ from our estimates.
SANOFI FORM 20-F 2025 | 69 |
PART I |
ITEM 5. Operating and Financial Review and Prospects |
A.2. Results of operations
Year ended December 31, 2025 compared with year ended December 31, 2024
Consolidated income statements
(€ million) | 2025 | As % of net sales | 2024 | As % of net sales |
Net sales | 43,626 | 100.0% | 41,081 | 100.0% |
Other revenues | 3,090 | 7.1% | 3,205 | 7.8% |
Cost of sales | (13,049) | -29.9% | (13,205) | -32.1% |
Gross profit | 33,667 | 77.2% | 31,081 | 75.7% |
Research and development expenses | (7,842) | -18.0% | (7,394) | -18.0% |
Selling and general expenses | (9,543) | -21.9% | (9,183) | -22.4% |
Other operating income | 1,231 | 1,089 | ||
Other operating expenses | (5,655) | (4,382) | ||
Amortization of intangible assets | (1,776) | (1,749) | ||
Impairment of intangible assets | (2,241) | (248) | ||
Fair value remeasurement of contingent consideration | (104) | (96) | ||
Restructuring costs and similar items | (1,138) | (1,396) | ||
Other gains and losses, and litigation | (255) | (470) | ||
Operating income | 6,344 | 14.5% | 7,252 | 17.7% |
Financial expenses | (563) | (1,073) | ||
Financial income | 394 | 519 | ||
Income before tax and investments accounted for using the equity method | 6,175 | 14.2% | 6,698 | 16.3% |
Income tax expense | (1,043) | (1,204) | ||
Share of profit/(loss) from investments accounted for using the equity method | (155) | 60 | ||
Net income from continuing operations | 4,977 | 5,554 | ||
Net income from discontinued operations | 2,874 | 64 | ||
Net income | 7,851 | 18.0% | 5,618 | 13.7% |
Net income attributable to non-controlling interests | 38 | 58 | ||
Net income attributable to equity holders of Sanofi | 7,813 | 17.9% | 5,560 | 13.5% |
Average number of shares outstanding (million) | 1,220.4 | 1,251.4 | ||
Average number of shares after dilution (million) | 1,225.6 | 1,256.1 | ||
•Basic earnings per share from continuing operations (€) | 4.05 | 4.40 | ||
•Basic earnings per share from discontinued operations (€) | 2.35 | 0.04 | ||
Basic earnings per share (€) | 6.40 | 4.44 | ||
•Diluted earnings per share from continuing operations (€) | 4.03 | 4.39 | ||
•Diluted earnings per share from discontinued operations (€) | 2.34 | 0.04 | ||
Diluted earnings per share (€) | 6.37 | 4.43 |
70 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 5. Operating and Financial Review and Prospects |
A.2.1. Net sales
Consolidated net sales for the year ended December 31, 2025 amounted to €43,626 million, 6.2% higher than in 2024 on a
reported basis. Exchange rate fluctuations had a negative effect of 3.7 percentage points overall, due mainly to adverse trends in
the US dollar against the euro. At constant exchange rates (CER), net sales rose by 9.9%, driven mainly by strong performances
for Dupixent and ALTUVIIIO.
Reconciliation of Net sales (IFRS) to Net sales at CER (non-IFRS)
(€ million) | 2025 | 2024 | Change |
Net sales (IFRS) | 43,626 | 41,081 | +6.2% |
Effect of exchange rates | (1,531) | ||
Net sales at constant exchange rates (non-IFRS) | 45,157 | 41,081 | +9.9% |
When we refer to changes in our net sales at constant exchange rates (CER), that means we have excluded the effect of
exchange rates by recalculating net sales for the relevant period using the exchange rates that were used for the previous period,
with the exception of countries treated as hyperinflationary economies under IAS 29 (i.e. Argentina and Turkey, see Note A.4. to
our consolidated financial statements).
1/ Net sales by operating segment
Our net sales comprise the net sales generated by our Biopharma segment.
(€ million) | 2025 | 2024 | Change on a reported basis (IFRS) | Change at constant exchange rates (non-IFRS) |
Biopharma segment | 43,626 | 41,081 | +6.2% | +9.9% |
Total net sales | 43,626 | 41,081 | +6.2% | +9.9% |
SANOFI FORM 20-F 2025 | 71 |
PART I |
ITEM 5. Operating and Financial Review and Prospects |
2/ Net sales by medicine, vaccine and geography – 2025 compared with 2024
(€ million) | Total sales | Change (on a reported basis) | Change (at CER) | United States | Change (at CER) | Europe | Change (at CER) | Rest of the world | Change (at CER) |
Immunology | |||||||||
Dupixent | 15,714 | +20.2% | +25.2% | 11,538 | +26.7% | 1,957 | +20.8% | 2,219 | +21.3% |
Kevzara | 507 | +19.6% | +23.6% | 321 | +36.6% | 127 | +5.0% | 59 | +7.0% |
Rare diseases | |||||||||
ALTUVIIIO (*) | 1,160 | +70.1% | +77.6% | 979 | +66.5% | — | —% | 181 | +183.1% |
Fabrazyme | 1,019 | -2.7% | +0.1% | 508 | -0.4% | 263 | +3.5% | 248 | -2.3% |
Nexviazyme / Nexviadyme (*) | 790 | +18.4% | +21.4% | 393 | +13.6% | 279 | +38.8% | 118 | +15.2% |
Cerezyme | 695 | -6.3% | -3.9% | 178 | -2.6% | 232 | -4.9% | 285 | -3.9% |
Alprolix | 603 | +2.6% | +7.0% | 454 | +1.7% | — | —% | 149 | +26.6% |
Myozyme | 519 | -22.7% | -21.0% | 173 | -23.1% | 173 | -33.5% | 173 | —% |
Cerdelga | 335 | +0.6% | +3.0% | 180 | +1.1% | 137 | +7.0% | 18 | -5.3% |
Aldurazyme | 305 | +2.7% | +5.1% | 74 | +8.3% | 84 | —% | 147 | +6.4% |
Ayvakit (*) | 305 | —% | —% | 267 | —% | 36 | —% | 2 | —% |
Eloctate | 275 | -25.3% | -22.3% | 178 | -21.6% | — | —% | 97 | -23.5% |
Cablivi (*) | 271 | +8.8% | +12.0% | 143 | +9.6% | 107 | +15.1% | 21 | +15.0% |
Xenpozyme (*) | 228 | +51.0% | +54.3% | 95 | +23.5% | 89 | +93.5% | 44 | +83.3% |
Qfitlia (*) | 9 | —% | —% | 9 | —% | — | —% | — | —% |
Wayrilz (Rilzabrutinib) (*) | 7 | —% | —% | 7 | —% | — | —% | — | —% |
Neurology | |||||||||
Aubagio | 238 | -37.2% | -35.4% | 135 | -24.1% | 67 | -55.9% | 36 | -10.0% |
Oncology | |||||||||
Sarclisa (*) | 588 | +24.8% | +28.5% | 244 | +27.5% | 174 | +29.9% | 170 | +28.5% |
Jevtana | 263 | -9.3% | -5.9% | 200 | -3.3% | 3 | -57.1% | 60 | -8.7% |
Fasturtec | 175 | -4.4% | -1.6% | 111 | -3.4% | 50 | +4.2% | 14 | -6.3% |
Other medicines | |||||||||
Lantus | 1,733 | +6.4% | +10.3% | 808 | +32.1% | 297 | -12.4% | 628 | +0.8% |
Toujeo | 1,345 | +9.6% | +12.0% | 240 | +15.2% | 500 | +4.4% | 605 | +17.5% |
Plavix | 910 | -0.4% | +3.1% | 6 | —% | 88 | -3.3% | 816 | +3.8% |
Lovenox | 822 | -16.3% | -14.4% | 11 | +22.2% | 455 | -19.9% | 356 | -7.4% |
Praluent | 526 | +8.9% | +9.3% | — | —% | 426 | +25.0% | 100 | -28.0% |
Rezurock (*) | 490 | +4.3% | +8.7% | 425 | +4.2% | 18 | -35.7% | 47 | +194.1% |
Thymoglobulin | 490 | -0.4% | +3.7% | 307 | +2.9% | 41 | +5.1% | 142 | +5.0% |
Aprovel | 417 | +0.2% | +3.1% | 4 | +25.0% | 71 | -2.7% | 342 | +4.1% |
Multaq | 314 | +1.0% | +5.1% | 285 | +6.8% | 10 | -9.1% | 19 | -9.1% |
Soliqua/iGlarLixi | 282 | +24.2% | +28.2% | 100 | +40.0% | 51 | +6.3% | 131 | +29.8% |
Tzield (*) | 63 | +16.7% | +22.2% | 59 | +19.2% | 2 | +100.0% | 2 | +100.0% |
Mozobil | 32 | -56.8% | -54.1% | 4 | -58.3% | 8 | -79.5% | 20 | -8.7% |
Others | 3,777 | -13.5% | -11.0% | 336 | -17.8% | 1,133 | -11.4% | 2,308 | -9.7% |
Industrial Sales | 483 | -7.6% | -6.1% | 1 | —% | 472 | -7.7% | 10 | +400.0% |
Vaccines | |||||||||
Polio / Pertussis / Hib Vaccines & Boosters | 2,554 | -6.8% | -4.4% | 632 | -3.1% | 450 | -9.5% | 1,472 | -3.3% |
COVID-19 (*) and Influenza vaccines | 2,314 | -9.4% | -5.8% | 1,328 | -1.9% | 556 | -13.1% | 430 | -7.9% |
RSV (Beyfortus) (*) | 1,781 | +5.6% | +9.5% | 723 | -27.9% | 601 | +36.1% | 457 | +168.5% |
Meningitis, Travel and Endemics Vaccines | 1,287 | -2.2% | +0.8% | 720 | +1.9% | 212 | +3.9% | 355 | -2.9% |
Biopharma | 43,626 | +6.2% | +9.9% | 22,176 | +16.3% | 9,169 | +1.6% | 12,281 | +5.6% |
Of which launches (*) | 5,721 | +29.1% | +34.0% | 3,361 | +20.4% | 1,306 | +38.3% | 1,054 | +99.6% |
72 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 5. Operating and Financial Review and Prospects |
3/ Net sales – Biopharma segment
In 2025, net sales for the Biopharma segment (see “— A.1.5. Segment Information and Business net income” for detailed
disclosures about our operating segment, and Note D.35. to our consolidated financial statements included at Item 18. of this
annual report) amounted to €43,626 million, up 6.2% on a reported basis and 9.9% at CER. The year-on-year reported-basis
increase of €2,545 million reflects adverse exchange rate effects amounting to €1,531 million, and the following principal effects
at CER:
•solid performances from Dupixent (net sales up €3,292 million, or 25.2 %) and ALTUVIIIO (net sales up €529 million); and
•the launch of Ayvakit (net sales of €325 million).
Comments on the performances of our major Biopharma segment products are provided below.
New launches
ALTUVIIIO (hemophilia A) posted net sales of €1,160 million in 2025, up 77.6% CER, with 84.4% generated in the US. Growth
continued to be driven by patient switching from older, short half-life and extended half-life factor medicines, including Eloctate,
and from non-factor treatments. Total hemophilia A franchise sales (ALTUVIIIO + Eloctate) amounted to €1,435 million (+42.6%
CER), representing an increase in Sanofi’s market share of factor-based treatments as well as of the overall hemophilia A market.
Nexviazyme/Nexviadyme (Pompe disease) sales were €790 million, up 21.4% year-on-year, driven by Europe (+38.8% CER), where
the rise was explained by switches from Myozyme/Lumizyme in the eligible late-onset Pompe disease population and an increase
in new patients. In the US, where sales reached €393 million, the majority of patients have now transitioned off
Myozyme/Lumizyme. Total sales for the Pompe franchise (Nexviazyme/Nexviadyme + Myozyme/Lumizyme) were €1,309 million.
Nexviazyme/Nexviadyme now account for 60.4 % of total Pompe franchise sales.
Sarclisa (multiple myeloma) reported sales of €588 million, up 28.5% CER, driven by strong growth in all three regions. Sales
reached €244 million in the US (+27.5% CER), €174 million in Europe (+29.9% CER), and €170 million in the Rest of the World
region (+28.5% CER). This significant progress is being largely driven by increased use in a front-line combination treatment
setting.
Sales of Rezurock (chronic graft-versus-host disease) were €490 million in 2025, an increase of 8.7% CER, driven by continued
growth in the US (€425 million, +4.2% CER), where the product is becoming the standard of care in the indicated setting, and by
rapid uptake in launch countries, especially China. Globally, over 20,000 patients have been prescribed Rezurock (including
patients in early access or managed access programs) since launch, key drivers being the product's real-world efficacy,
tolerability and oral route of administration.
Ayvakit (mastocytosis) sales were €305 million. Ayvakit has been consolidated by Sanofi since mid-July 2025 following the
acquisition of Blueprint. Sales were split between the US (€267 million) and Europe (€36 million) with continued growth in the
number of patients treated. Annual sales reached $725 million, slightly ahead of Blueprint's expectations from earlier in the year
(estimated at $700-$720 million). Sanofi does not hold marketing rights in China but receives royalties on sales by CStone
Pharmaceuticals CO., Ltd.
Cablivi (acquired thrombotic thrombocytopenic purpura) reported 2025 sales of €271 million (+12.0% CER), including €143 million
(+9.6% CER) in the US, driven by more patients being identified for treatment in the US and Europe and less use of the US access
program.
Xenpozyme (acid sphingomyelinase deficiency) achieved sales of €228 million in 2025, an increase of 54.3% CER, mainly driven
by Europe where net sales rose by 93.5% CER.
Sales of Tzield (delayed onset of type 1 diabetes) amounted to €63 million, of which €59 million was generated in the US (+19.2%
CER). Patient screenings continued to increase, driving slight growth in the number of patients treated.
Sales of Qfitlia (hemophilia A and B) totaled €9 million, all of which was generated in the US, following approval in March 2025.
Sales of Wayrilz (immune thrombocytopenia) totaled €7 million, all of which was generated in the US, following approval in August
2025.
Immunology
Dupixent generated net sales of €15,714 million in 2025, up 20.2% on a reported basis and 25.2% at CER, driven by continuing
strong demand in the product’s approved indications: atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis,
eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, chronic obstructive pulmonary disease, and bullous
pemphigoid. Dupixent net sales for 2025 by geography were €11,538 million (+26.7% CER) in the US, €1,957 million (+20.8% CER)
in Europe, and €2,219 million (+21.3% CER) in the Rest of the World region.
Other main medicines
Lantus sales were €1,733 million, up 10.3% CER. US sales were €808 million, up 32.1% CER, benefiting from the unavailability of
competing medicines. Customer demand is now expected to normalize in 2026. In Europe, net sales decreased by 12.4% CER; in
the Rest of the World region, sales were up 0.8% CER, mainly due to the strategy of switching to Toujeo in China.
Toujeo sales rose by 12.0% CER to €1,345 million, led by the Rest of the World region where net sales were up 17.5% CER at
€605 million. Toujeo increased its market share, especially in basal insulins, led by China where the product’s market share now
exceeds that of Lantus.
Sales of Fabrazyme reached €1,019 million in 2025 (+0.1% CER), with a slight rise in the number of patients.
SANOFI FORM 20-F 2025 | 73 |
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ITEM 5. Operating and Financial Review and Prospects |
Plavix sales stabilized, posting growth of 3.1% CER to €910 million, mainly reflecting volume growth in China due to inclusion in the
volume-based procurement (VBP) program, partly offset by market share slowdown in the other countries within the Rest of the
World region (which represents the majority of sales at €816 million).
Lovenox sales were down 14.4 % CER at €822 million, reflecting impacts from increasing competition in Europe and the Rest of
the World region.
Cerezyme sales decreased by 3.9% CER to €695 million. Sales for the global Gaucher disease franchise (Cerezyme and Cerdelga)
reached €1,030 million.
In 2025, sales of Alprolix amounted to €603 million, up 7.0% CER, driven by the Rest of the World region (+26.6% CER) and the US
(+1.7% CER), due to supply sales under the collaboration with Sobi.
Net sales of Praluent for 2025 reached €526 million, up 9.3% CER, underpinned by Europe (+25.0%) but partially mitigated by a
decrease in the Rest of the World region of 28.0%.
Sales of Myozyme/Lumizyme decreased by 21.0% CER in 2025 to €519 million, reflecting patient switches to
Nexviazyme/Nexviadyme as mentioned above.
Thymoglobulin sales rose by 3.7% CER to €490 million, driven by the US (+2.9% CER) and the Rest of the World region (+5.0%
CER).
Cerdelga sales were €335 million, up 3.0%, reflecting growth in the number of patients.
Eloctate posted sales of €275 million in 2025, down 22.3% CER, as patients switched to ALTUVIIIO.
Sales of Aubagio were down 35.4% CER at €238 million, reflecting the loss of exclusivity in the US in March 2023 (-24.1% CER in
2025), followed by the loss of exclusivity in Europe in September 2023 (-55.9% CER in 2025). Individual sales reporting for
Aubagio is anticipated to discontinue in 2026 with any remaining sales to be included in the “Others” category.
Vaccines
In 2025, Vaccines sales were €7,936, down 4.4% on a reported basis and 1.2% CER, reflecting lower sales of influenza vaccines.
Sales of Polio/Pertussis/Hib Vaccines and Boosters reached €2,554 million, down 4.4% CER.
Influenza, COVID-19 vaccines sales were €2,314 million, down 5.8% CER in a contracted market. Sales in Europe (-13.1% CER) were
impacted by price reductions in Germany, while sales in the US (-1.9% CER) were impacted by soft vaccination rates.
Beyfortus sales reached €1,781 million, up 9.5% CER. Sales in Europe of €601 million (+36.1% CER) and in the Rest of World region
of €457 million (+168.5% CER) were driven by the geographical rollout of all-infant protection. Beyfortus now protects infants in
more than 45 countries. Sales in the US were down 27.9% CER at €723 million due to a high base effect and existing inventory
levels at the beginning of the season.
Meningitis, Travel and Endemics Vaccines sales increased by 0.8% CER to €1,287 million.
4/ Net sales by geographical region
The table below sets forth our net sales for 2025 and 2024 by geographical region:
(€ million) | 2025 | 2024 | Change on a reported basis | Change at constant exchange rates |
United States | 22,176 | 19,986 | +11.0% | +16.3% |
Europe | 9,169 | 9,027 | +1.6% | +1.6% |
Rest of the World | 12,281 | 12,068 | +1.8% | +5.6% |
of which China | 2,621 | 2,666 | -1.7% | +2.0% |
Total net sales | 43,626 | 41,081 | +6.2% | +9.9% |
In 2025, net sales in the United States reached €22,176 million, up 11.0% on a reported basis and 16.3% CER, driven by exceptional
performances from Dupixent (+26.7% CER at €11,538 million) and ALTUVIIIO (+66.5% CER at €979 million).
In Europe, net sales rose by 1.6% on a reported basis and by the same rate at CER in 2025 to €9,169 million, led by Dupixent and
Beyfortus with growth of 20.8% (€1,957 million) and 36.1% (€601 million), respectively.
In the Rest of the World region, net sales for 2025 increased by 1.8% on a reported basis and by 5.6% CER to €12,281 million, due
to strong performances from Dupixent (+21.3% CER at €2,219 million) and Beyfortus (+168.5% CER at €457 million).
A.2.2. Other income statement items
1/ Other revenues
Other revenues decreased by 3.6% to €3,090 million in 2025 (versus €3,205 million in 2024).
The Other revenues line item includes VaxServe sales of non-Sanofi products, amounting to €1,780 million (versus €1,959 million
in 2024). It also includes sales of Opella products in markets retained by Sanofi (€487 million); supply sales to Opella (€120 million);
royalties (€146 million); and other services/manufacturing services (€557 million).
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2/ Gross profit
Gross profit for 2025 amounted to €33,667 million compared with €31,081 million in 2024, an increase of 8.3%. Gross margin (the
ratio of gross profit to net sales) increased, reaching 77.2% in 2025, versus 75.7% in 2024, due to improvements in Cost of sales.
3/ Research and development expenses
R&D expenses amounted to €7,842 million in 2025, versus €7,394 million in 2024, an increase of 6.1%, and represented 18.0% of
our net sales in 2025 (compared with 18.0% in 2024). R&D spend, excluding the 2024 one-off Sobi reimbursement following the
registration of ALTUVIIIO in Europe, increased 6.3% year-on-year, driven by strategic prioritization of key therapeutic growth
areas (in particular in immunology, rare diseases, neurology and vaccines) and wind-down costs for the discontinued E. coli sepsis
vaccine candidate, as well as new acquisitions and in‑licensing agreements completed in 2025. Oncology spend was selectively
reduced to support portfolio rebalancing to immunology.
4/ Selling and general expenses
Selling and general expenses amounted to €9,543 million in 2025 (21.9% of net sales), versus €9,183 million in 2024 (22.4% of net
sales), a 3.9% year-on-year increase. The overall increase reflects continued support for launches and newer medicines in
Specialty Care and Vaccines. However, the ratio of selling and general expenses to net sales was 0.5% lower than in 2024,
reflecting improved operational efficiency and leverage as Sanofi scales its commercial operations. This positive trend illustrates
Sanofi's ability to drive revenue growth while maintaining disciplined cost management, with sales growing faster than the
associated selling and general expenses. The improvement in the ratio reflects the benefits of commercial excellence initiatives,
optimized resource allocation, and economies of scale achieved across key markets and therapeutic areas.
5/ Other operating income and expenses
Other operating income amounted to €1,231 million in 2025 (versus €1,089 million in 2024), and other operating expenses
to €5,655 million (versus €4,382 million in 2024).
Other operating income includes (i) gains from asset divestments, amounting to €485 million in 2025 (versus €539 million in
2024); (ii) out-licensing income from Amvuttra, amounting to €475 million in 2025 (versus €186 million in 2024); and (iii) income
from Sanofi’s pharmaceutical partners, amounting to €189 million in 2025 (including €149 million from Regeneron, see Note D.26.
and Note C.1. to our consolidated financial statements included at Item 18. of this annual report), compared with €221 million in
2024 (including €166 million from Regeneron).
Other operating expenses include €5,072 million of expenses related to Regeneron (see Note C.1. to our consolidated financial
statements included at Item 18. of this annual report), compared with €3,955 million for 2024.
Overall, this represented a net expense of €4,424 million in 2025, compared with a net expense of €3,293 million in 2024.
(€ million) | 2025 | 2024 | Change |
Other operating income | 1,231 | 1,089 | 142 |
Other operating expenses | (5,655) | (4,382) | (1,273) |
Other operating income/(expenses), net | (4,424) | (3,293) | (1,131) |
The change of €1,131 million mainly reflects an increase in the share of profits generated by the monoclonal antibody alliance with
Regeneron under the collaboration agreement (see Note C.1. to our consolidated financial statements included at Item 18. of this
annual report), the principal factor being increased sales of Dupixent.
The net contribution of items related to Regeneron to this line item is as follows:
(€ million) | 2025 | 2024 |
Income & expense related to (profit)/loss sharing under the Monoclonal Antibody Alliance | (5,455) | (4,143) |
Additional share of profit paid by Regeneron towards development costs(a) | 1,089 | 833 |
Reimbursement to Regeneron of selling expenses incurred | (699) | (637) |
Total: Monoclonal Antibody Alliance | (5,065) | (3,947) |
Other (mainly Zaltrap and Libtayo) | 142 | 158 |
Other operating income/(expenses), net related to Regeneron Alliance | (4,923) | (3,789) |
of which amount presented in “Other operating income” | 149 | 166 |
(a)As of December 31, 2025, the commitment received by Sanofi in respect of the additional profit share payable by Regeneron towards development
costs amounted to €0.5 billion, compared with €1.6 billion as of December 31, 2024.
6/ Amortization of intangible assets
Amortization charged against intangible assets amounted to €1,776 million in 2025, compared with €1,749 million in 2024.
This increase was mainly driven by amortization of the Ayvakit intangible asset following the acquisition of Blueprint, partly offset
by some intangible assets reaching the end of their amortization periods.
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7/ Impairment of intangible assets, net of reversals
In 2025, this line corresponds to the recognition of net impairment losses of €2,241 million in 2025, and mainly comprises a €1,663
million impairment loss recognized on tolebrutinib, a drug candidate in the registration phase targeting multiple sclerosis,
reflecting the reduced probability of approval arising from the negative PERSEUS phase 3 study results and recent exchanges
with the FDA and EMA. For 2024, this line includes a net impairment charge of €248 million, mainly due to (i) recognition of
impairment losses of €640 million against various research and development projects (including a €239 million loss resulting from
the decision taken in February 2025 to discontinue a Phase 3 clinical study investigating a vaccine candidate to prevent invasive
E.coli disease), partially offset by (ii) impairment loss reversals recognized in connection with the disposals of the ProXTen
platform and Enjaymo, for €225 million and €167million respectively.
8/ Fair value remeasurement of contingent consideration
Fair value remeasurements of contingent consideration assets and liabilities (recognized on acquisitions or disposals of
activities) represented a net expense of €104 million in 2025, versus a net expense of €96 million in 2024.
9/ Restructuring costs and similar items
Restructuring costs and similar items represented a total charge of €1,138 million in 2025, versus a charge of €1,396 million in
2024, a decrease of €258 million. In 2025, this line item mainly comprised (i) costs related to the social plans announced during
the year and (ii) transaction, integration and separation costs associated with significant acquisitions or disposals (€312 million),
mainly related to the acquisition of Blueprint. In 2024, restructuring and similar costs mainly comprised the impacts of (i) the
renewal of the Job Management and Career Paths (GEPP) program in France to cover the 2024-2026 period, including scope
extensions in the job profiles affected by transformations and (ii) a voluntary redundancy program announced in 2024 in
connection with the reorganization of R&D operations to make Sanofi a leader in immunology.
10/ Other gains and losses, and litigation
Other gains and losses, and litigation for 2025 represented a charge of €255 million related to major litigation.
For 2024, this line item represented a charge of €470 million, mainly comprising a provision recognized in respect of the litigation
related to Plavix (clopidogrel) in the US state of Hawaii.
11/ Operating income
Operating income amounted to €6,344 million in 2025, versus €7,252 million in 2024. The year-on-year decrease was mainly
due to an increase in net impairment losses charged against intangible assets.
12/ Financial income and expenses
Net financial expenses were €169 million in 2025, versus €554 million in 2024, a decrease of €385 million.
The 2025 amount includes financial income of €93 million (€291 million expense in 2024) in respect of the liability recognized in
the balance sheet for estimated future royalties on US sales of Beyfortus (see Notes C.2. and D.29. to our consolidated financial
statements included at Item 18. of this annual report).
The cost of our net debt (see the definition in “— B. Liquidity and Capital Resources” below and Note D.29. to our consolidated
financial statements included at Item 18. of this annual report ) was €166 million in 2025, compared with €186 million in 2024.
13/ Income before tax and investments accounted for using the equity method
Income before tax and investments accounted for using the equity method reached €6,175 million in 2025, versus
€6,698 million in 2024.
14/ Income tax expense
Income tax expense represented €1,043 million in 2025, versus €1,204 million in 2024, giving an effective tax rate (IFRS) based on
consolidated net income of 16.9% in 2025, compared with 18.0% in 2024. The reduction in income tax expense was mainly due to
tax effects arising from increases in impairment of intangible assets linked to research and development projects, including tax
effects arising from the €1,663 million impairment loss charged against intangible assets related to the tolebrutinib research
program.
The effective tax rate based on business net income is a non-IFRS financial measure (see definition under “— A.1.5. Segment
information — Business Net Income” above). It is calculated on the basis of business operating income, minus net financial
expenses and before (i) the share of profit/loss from investments accounted for using the equity method and (ii) net income
attributable to non-controlling interests. We believe the presentation of this measure, used by our management, is also useful for
investors as it provides a means to analyze the effective cost of taxes on our profits excluding (i) the reconciling items described
in section A.1.5. above and (ii) non-recurring or unusual tax effects. However, it should not be seen as a substitute for the effective
tax rate based on our consolidated net income.
When calculated on business net income, our effective tax rate (non-IFRS) was 19.9% in 2025, compared with 19.8% in 2024. The
main factors in this year-on-year change were (i) the impact of the OECD Pillar Two model rules, which aim to ensure that large
multinationals pay a minimum level of tax on the income arising in each jurisdiction where they operate; and (ii) updates to
estimates of prior period tax liabilities following progress of reviews and closure of open issues with tax authorities in various
jurisdictions.
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The table below reconciles our effective tax rate based on consolidated net income to our effective tax rate based on business
net income:
(as a percentage) | 2025 | 2024 |
Effective tax rate based on consolidated net income (IFRS) | 16.9% | 18.0% |
Tax effects: | ||
Amortization and impairment of intangible assets | 1.2 | (0.4) |
Restructuring costs and similar items | 0.6 | 0.5 |
Other tax effects | 1.2 | 1.7 |
Effective tax rate based on business net income (non-IFRS) | 19.9% | 19.8% |
15/ Share of profit/(loss) from investments accounted for using the equity method
The line item Share of profit/(loss) from investments accounted for using the equity method showed a net loss of €155 million
in 2025, including a loss of €310 million on the equity-accounted investment in the associate OPAL JV Co (see Note D.6),
compared with a net gain of €60 million for 2024.
16/ Net income from continuing operations
Net income from continuing operations amounted to €4,977 million in 2025, compared with €5,554 million in 2024.
17/ Net income from discontinued operations
Due to (i) the classification of Opella's assets and liabilities as held for sale since the announcement on October 21, 2024 of the
opening of exclusive negotiations with CD&R for the transfer of those assets and liabilities and (ii) the assessment that Opella
qualifies as a principal line of business within the meaning of IFRS 5, the net income or loss of Opella is presented in a separate line
item, Net income from discontinued operations (see Notes D.1. and D.36. to our consolidated financial statements included at
Item 18. of this annual report).
In 2025, Net income from discontinued operations amounted to €2,874 million, reflecting the net income of Opella until the
date of loss of control and also including a net gain of €2.6 billion resulting from the divestment of Opella as of the date of loss of
control.
In 2024, Net income from discontinued operations amounted to €64 million.
18/ Net income attributable to non-controlling interests
Net income attributable to non-controlling interests was €38 million in 2025, versus €58 million in 2024.
19/ Net income attributable to equity holders of Sanofi
Net income attributable to equity holders of Sanofi amounted to €7,813 million in 2025, compared with €5,560 million in 2024.
Basic earnings per share for 2025 was €6.40 versus €4.44 for 2024, based on an average number of shares outstanding
of 1,220.4 million in 2025 and 1,251.4 million in 2024. Diluted earnings per share for 2025 was €6.37 versus €4.43 for 2024, based
on an average number of shares after dilution of 1,225.6 million in 2025 and 1,256.1 million in 2024.
A.2.3. Segment results
For the Biopharma segment, business operating income (as defined in Note D.35. to our consolidated financial statements
included at Item 18. of this annual report) was €12,123 million in 2025, compared with €11,285 million in 2024 (an increase of 7.4%).
It represented 27.8% of our net sales in 2025, compared with 27.5% in 2024.
B. Liquidity and capital resources
Our operations generate significant positive cash flows. We fund our day-to-day investments (with the exception of significant
acquisitions) primarily with operating cash flow, and pay regular dividends on our shares.
“Net debt” is a non-IFRS financial indicator which is reviewed by our management, and which we believe provides useful
information to measure our overall liquidity and capital resources. We define “net debt” as (i) the sum total of long-term debt,
short-term debt and current portion of long-term debt, and interest rate and currency derivatives used to manage debt, minus
(ii) the sum total of cash and cash equivalents and interest rate and currency derivatives used to manage cash and cash
equivalents. Lease liabilities are not included in net debt.
As of December 31, 2025 our total debt was €18,702 million and our net debt was €11,008 million, compared with €16,137 million
and €8,772 million, respectively, as of December 31, 2024. See reconciliation of total debt to net debt in "— B.2. Consolidated
balance sheet and debt" below.
In order to assess our financing risk, we also use the “gearing ratio," a non-IFRS financial measure (see table in section
“— B.2. Consolidated balance sheet and debt” below). We define the gearing ratio as the ratio of net debt to total equity. As
of December 31, 2025, our gearing ratio was 15.4%, compared with 11.3% as of December 31, 2024.
Because our net debt and gearing ratio are not standardized measures, they may not be directly comparable with the non-IFRS
financial measures of other companies using the same or similar non-IFRS financial measures. Despite the use of non-IFRS
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ITEM 5. Operating and Financial Review and Prospects |
measures by management in setting goals and measuring performance, these are non-IFRS measures that have no standardized
meaning prescribed by IFRS.
B.1. Consolidated statement of cash flows
Generally, factors that affect our earnings – for example, pricing, volume, costs and exchange rates – flow through to cash from
operations. The most significant source of cash from operations is sales of our branded medicines and vaccines. Receipts of
royalty payments also contribute to cash from operations.
Summarized consolidated statements of cash flows
(€ million)(a) | 2025 | 2024 |
Net cash provided by/(used in) continuing operating activities | 10,561 | 8,607 |
Net cash provided by/(used in) operating activities of the discontinued Opella business | 189 | 474 |
Net cash provided by/(used in) operating activities | 10,750 | 9,081 |
Net cash provided by/(used in) continuing investing activities | (12,849) | (4,298) |
Net cash provided by/(used in) investing activities of the discontinued Opella business | (36) | (109) |
Net cash inflow from the Opella transaction(b) | 10,438 | — |
Net cash provided by/(used in) investing activities | (2,447) | (4,407) |
Net cash provided by/(used in) continuing financing activities | (8,159) | (5,751) |
Net cash provided by/(used in) financing activities of the discontinued Opella business | (48) | (12) |
Net cash provided by/(used in) financing activities | (8,207) | (5,763) |
Impact of exchange rates on cash and cash equivalents | (47) | (13) |
Cash and cash equivalents reported as “Assets held for sale" as of December 31, 2024 | 167 | (167) |
Net change in cash and cash equivalents | 216 | (1,269) |
Cash and cash equivalents, beginning of period | 7,441 | 8,710 |
Cash and cash equivalents, end of period | 7,657 | 7,441 |
(a)Cash flows of the Opella business are presented separately in accordance with IFRS 5 (Non-current Assets Held for sale and Discontinued Operations).
(b)For 2025, this amount includes €(667) million in respect of cash and cash equivalents held by Opella as of April 30, 2025. As of December 31, 2024, cash
and cash equivalents held by Opella amounted to €167 million and were reported in "Assets held for sale" in the balance sheet as of that date.
Net cash provided by/used in continuing operating activities represented a net cash inflow of €10,561 million in 2025,
compared with €8,607 million in 2024. The year-on-year increase was due mainly to a lower level of operating cash flow before
changes in working capital (€8,766 million in 2025, versus €9,222 million in 2024), more than offset by a net increase of
€1,795 million in the working capital requirement in 2025 (versus a net decrease of €615 million in 2024), including the change in
the US rebate provisions (€1,330 million) following the decision to reduce the Lantus list price effective January 1, 2024.
Net cash provided by/used in continuing investing activities represented a net cash outflow of €12,849 million in 2025,
compared with a net outflow of €4,298 million in 2024. The principal cash outflow in 2025 was the €9,394 million arising from
Acquisitions of consolidated undertakings and investments accounted for using the equity method, in particular Blueprint
Medicines (€7,542 million) and Vicebio (€968 million); that compares with an outflow of €1,901 million in 2024 (mainly related to
the acquisition of Inhibrx for $2,035 million).
Acquisitions of property, plant and equipment and intangible assets amounted to €3,538 million, versus €3,195 million in 2024.
There were €1,762 million of acquisitions of property, plant and equipment (versus €1,733 million in 2024), most of which related
to industrial facilities. Acquisitions of intangible assets (€1,776 million, versus €1,462 million in 2024) mainly comprised contractual
payments for intangible rights under license and collaboration agreements.
Proceeds from disposals of property, plant and equipment, intangible assets and other non-current assets, net of tax
amounted to €847 million in 2025 versus €1,461 million in 2024; the 2024 figure mainly comprised the sale of the Enjaymo global
rights to Recordati for pre-tax proceeds of €768 million.
Net cash provided by/used in continuing financing activities represented a net cash outflow of €8,159 million in 2025,
compared with a net cash outflow of €5,751 million in 2024. The 2025 figure includes the redemption of €2.6 billion of bonds, and
the issuance of new bonds for €1.5 billion, €1.5 billion and $3.0 billion respectively. Other movements mainly included (i) the
dividend payout to our shareholders of €4,772 million (versus €4,704 million in 2024); and (ii) a cash outflow of €5,030 million on
purchases of treasury shares (versus €302 million in 2024).
The net change in cash and cash equivalents of continuing operations in 2025 was a decrease of €9 million, versus a
decrease of €1,442 million in 2024.
Net cash flows of the discontinued Opella business represented a net cash inflow of €105 million in 2025 versus a net cash
inflow of €353 million in 2024.
Net cash inflow from the Opella transaction represented a net cash inflow of €10,438 million in 2025. This amount includes
€(667) million in respect of cash and cash equivalents held by Opella as of April 30, 2025. As of December 31, 2024, cash and
cash equivalents held by Opella amounted to €167 million, and were reported in Assets held for sale in the balance sheet as of
that date.
(1)Above a cap of €500 million per transaction.
(2)Non-IFRS financial measure, as defined in “— Segment Information — Business Net income” above.
(3)Not exceeding a cap of €500 million per transaction.
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The net change in cash and cash equivalents during 2025 was an increase of €216 million; this compares with a decrease of
€1,269 million in 2024.
“Free cash flow” (a non-IFRS measure) for the year ended December 31, 2025 was €8,089 million, an increase from the 2024
figure of €5,955 million.
For details of the arrangements in place to manage our liquidity needs for current operations as of December 31, 2025, refer to
Note 17.1.(b) to our consolidated financial statements, included at Item 18. of this annual report.
“Free cash flow” is a non-IFRS financial indicator which is reviewed by our management, and which we believe provides useful
information to measure the net cash generated from our operations that is available for strategic investments(1) (net of
divestments(1)), for debt repayment, and for payments to shareholders. “Free cash flow” comprises cash flows generated from our
continuing operations; it is calculated from our “Business net income”(2) after adding back (in the case of expenses and losses) or
deducting (in the case of income and gains) the following items: depreciation, amortization and impairment, share of undistributed
earnings from investments accounted for using the equity method, gains & losses on disposals, net change in provisions including
pensions and other post-employment benefits, deferred taxes, share-based payment expense and other non-cash items. It also
includes net changes in working capital, capital expenditures and other asset acquisitions(3) net of disposal proceeds(3), and
payments related to restructuring and similar items. “Free cash flow” is not defined by IFRS, and is not a substitute for Net cash
provided by operating activities as reported under IFRS. Management recognizes that the term “Free cash flow” may be
interpreted differently by other companies and under different circumstances.
The table below sets forth a reconciliation between Net cash provided by continuing operating activities and “Free cash flow”:
(€ million) | 2025 | 2024 |
Net cash provided by/(used in) operating activities (IFRS) | 10,750 | 9,081 |
Net cash provided by/(used in) operating activities (IFRS) of the discontinued Opella business | (189) | (474) |
Acquisitions of property, plant and equipment and software | (1,858) | (1,808) |
Acquisitions of intangible assets, equity interests and other non-current financial assets(a) | (1,761) | (1,434) |
Proceeds from disposals of property, plant and equipment, intangible assets and other non-current assets, net of tax(a) | 744 | 805 |
Repayments of lease liabilities(b) | (333) | (282) |
Other items(c) | 736 | 67 |
Free cash flow (non-IFRS) | 8,089 | 5,955 |
(a)Free cash flow includes investments and divestments not exceeding a cap of €500 million per transaction.
(b)Cash outflows relating to repayments of the principal portion of lease liabilities (IFRS 16) are included in free cash flow.
(c)This line item includes cash outflows from major litigation not included in "Free cash flow," in particular the Plavix litigation in Hawaii in 2025.
B.2. Consolidated balance sheet and debt
Total assets were €126,805 million as of December 31, 2025, compared with €132,798 million as of December 31, 2024, a decrease
of €5,993 million.
Total equity was €71,710 million as of December 31, 2025, versus €77,857 million as of December 31, 2024. The year-on-year net
change reflects the following principal factors:
•increases: our net income for 2025 (€7,851 million); and
•decreases: the dividend paid to our shareholders in respect of the 2024 financial year (€4,772 million), repurchases of our own
shares (€5,015 million) and negative currency translation differences (€4,867 million).
“Total debt” was €18,702 million as of December 31, 2025, compared with €16,137 million as of December 31, 2024. "Net debt" was
€11,008 million as of December 31, 2025, compared with €8,772 million as of December 31, 2024. The increase in 2025 mainly
reflects cash outflows related to (i) acquisitions exceeding a cap of €500 million per transaction (cash outflow of €10,986 million)
and (ii) the dividend payout to our shareholders (cash outflow of €4,772 million), less the €8,089 million of free cash flow
generated from continuing operations in the year (see reconciliation with Net cash provided by/(used in)operating activities in
section B.1. above) and the €10,443 million cash inflow from the Opella transaction.
“Net debt” is a non-IFRS financial measure which is reviewed by our management, and which we believe provides useful
information to measure our overall liquidity and capital resources. We define “net debt” as (i) the sum total of long-term debt,
short-term debt and current portion of long-term debt and interest rate and currency derivatives used to manage debt, minus
(ii) the sum total of cash and cash equivalents and interest rate and currency derivatives used to manage cash and cash
equivalents.
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(€ million) | 2025 | 2024 |
Long-term debt | 14,248 | 11,791 |
Short-term debt and current portion of long-term debt | 4,342 | 4,209 |
Interest rate and currency derivatives used to manage debt | 112 | 137 |
Total debt | 18,702 | 16,137 |
Cash and cash equivalents | (7,657) | (7,441) |
Interest rate and currency derivatives used to manage cash and cash equivalents | (37) | 76 |
Net debt(a) (non- IFRS) | 11,008 | 8,772 |
Total equity | 71,710 | 77,857 |
Gearing ratio (non-IFRS) | 15.4% | 11.3% |
(a)Net debt does not include lease liabilities, which amounted to €1,739 million as of December 31, 2025 and €1,906 million as of December 31, 2024.
“Net debt” is a non-IFRS financial measure used by management and investors to measure Sanofi’s overall net indebtedness.
To assess our financing risk, we use the “gearing ratio”, a non-IFRS financial measure. This ratio (which we define as the ratio of
net debt to total equity) increased from 11.3% as of December 31, 2024 to 15.4% as of December 31, 2025. Analyses of debt as
of December 31, 2025 and December 31, 2024 by type, maturity, interest rate and currency, are provided in Note D.17.1. to our
consolidated financial statements, included at Item 18. of this annual report.
We expect that the future cash flows generated by our operating activities will be sufficient to repay our debt. The financing
arrangements in place as of December 31, 2025 at the Sanofi parent company level are not subject to covenants regarding
financial ratios and do not contain any clauses linking fees to Sanofi’s credit rating.
As of December 31, 2025, we held 11.96 million of our own shares, recorded as a deduction from equity and representing 0.98% of
our share capital. As of December 31, 2024, we were holding 9.5 million of our own shares, recorded as a deduction from equity
and representing 0.75% of our share capital.
Goodwill and Other intangible assets (€67,561 million in total) increased by €1,548 million, driven mainly by new acquisitions
(DR-0201, Blueprint, Vigil and Vicebio), partly offset by amortization and impairment charged during the period and movements
in currency translation differences.
Investments accounted for using the equity method (€3,259 million) increased by €2,943 million, mainly reflecting the
acquisition of 48.2% in the associate OPAL JV Co.
Other non-current assets amounted to €4,364 million, a year-on-year increase of €611 million.
Net deferred tax assets amounted to €6,942 million as of December 31, 2025, versus €5,801 million as of December 31, 2024, a
year-on-year increase of €1,141 million. The year-on-year increase mainly reflects (i) an increase in tax losses available for carry-
forward; and (ii) an increase in deferred tax assets arising on the spread tax deduction of R&D expenses in the US.
Non-current provisions and other non-current liabilities (€6,703 million) showed a decrease of €1,393 million, mainly due to
funding of pension obligations and various litigation settlements.
Liabilities related to business combinations and to non-controlling interests were €56 million lower year-on-year, at
€585 million.
Assets held for sale (€208 million) and Liabilities related to assets held for sale (€54 million) were both substantially lower than
in 2024, when these line items included the assets and liabilities of the held-for-sale Opella business, over which Sanofi lost
control in 2025 (see Note D.8. to our consolidated financial statements included at Item 18. of this annual report).
B.3. Liquidity
We expect that our existing cash resources and cash from operations will be sufficient to finance our foreseeable working capital
requirements, in both the short term (i.e. the 12 months following the year ended December 31, 2025) and the long term
(i.e. beyond such additional 12-month period). As of December 31, 2025, we held cash and cash equivalents amounting to
€7,657 million (see Note D.13. to our consolidated financial statements included at Item 18. of this annual report). As of December
31, 2025, €490 million of our cash and cash equivalents were held by captive insurance and reinsurance companies in
accordance with insurance regulations.
We run the risk of delayed payments or even non-payment by our customers, who consist principally of wholesalers, distributors,
pharmacies, hospitals, clinics and government agencies (see “Item 3. Key information — D. Risk Factors — 2. Risks Relating to Our
Business — We are subject to the risk of non-payment by our customers”). Deteriorating credit and economic conditions and other
factors in some countries have resulted in, and may continue to result in, an increase in the average length of time taken to collect our
accounts receivable in these countries. Should these factors continue, it may require us to re-evaluate the collectability of these
receivables in future periods. We carefully monitor sovereign debt issues and economic conditions and evaluate accounts receivable in
these countries for potential collection risks. We have been conducting an active recovery policy, adapted to each country and including
intense communication with customers, negotiations of payment plans, charging of interest for late payments, and legal action. Over our
business as a whole, the amount of trade receivables overdue by more than 12 months (which primarily consists of amounts due from
public sector bodies) increased from €44 million as of December 31, 2024 to €52 million as of December 31, 2025 (see Note D.10. to our
consolidated financial statements included at Item 18. of this annual report).
80 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 5. Operating and Financial Review and Prospects |
As of December 31, 2025, we had no commitments for capital expenditures that we consider to be material to our consolidated
financial position. Undrawn confirmed credit facilities amounted to a total of €8,000 million at December 31, 2025. For a
discussion of our treasury policies, see “Item 11. Quantitative and Qualitative Disclosures about Market Risk.”
We expect that cash from our operations will be sufficient to repay our debt. For a discussion of our liquidity risks,
see “Item 11. Quantitative and Qualitative Disclosures about Market Risk.”
B.4. Off balance sheet arrangements/Contractual obligations and other commercial commitments
We have various contractual obligations and other commercial commitments arising from our operations. Our contractual
obligations and our other commercial commitments as of December 31, 2025 are shown in Notes D.3., D.17., D.18., and D.21. to our
consolidated financial statements included at Item 18. of this annual report. Note D.21. to our consolidated financial statements
included at Item 18. of this annual report discloses details of commitments under our principal research and development
collaboration agreements. For a description of the principal contingencies arising from certain business divestitures, refer to
Note D.22. to our 2025 consolidated financial statements included at Item 18. of this annual report.
Off balance sheet commitments relating to Sanofi’s operating activities, not including as of December 31, 2025 the commitments
of the held-for-sale Opella operation, comprise the following (for Opella off balance sheet commitments, refer to Note D.36.):
December 31, 2025 | Payments due by period | ||||
(€ million) | Total | Less than 1 year | 1 to 3 years | 3 to 5 years | More than 5 years |
Future contractual cash flows relating to debt and debt hedging instruments(a) | 20,431 | 4,653 | 5,805 | 5,412 | 4,561 |
Principal payments related to lease liabilities(b) | 1,929 | 303 | 532 | 409 | 685 |
Other lease obligations (with a term of less than 12 months, low value asset leases and lease contracts committed but not yet commenced)(c) | 476 | 26 | 23 | 44 | 383 |
Irrevocable purchase commitments(d) | |||||
•Given | 5,098 | 1,999 | 1,414 | 810 | 875 |
•Received | (2,356) | (411) | (595) | (540) | (810) |
Research & development license agreements | |||||
•Commitments related to R&D and other commitments | 221 | 196 | 16 | 4 | 5 |
•Potential milestone payments(e) | 5,341 | 373 | 1,413 | 1,027 | 2,528 |
Obligations relating to business combinations(f) | 476 | 127 | — | — | 349 |
Estimated benefit payments on unfunded pensions and post employment benefits(g) | 985 | 63 | 109 | 116 | 697 |
Total contractual obligations and other commitments | 32,601 | 7,329 | 8,717 | 7,282 | 9,273 |
Undrawn general-purpose credit facilities | 8,000 | — | 4,000 | 4,000 | — |
(a)See Note D.17.1. to our consolidated financial statements, included at Item 18. of this annual report.
(b)See Note D.17.2. to our consolidated financial statements, included at Item 18. of this annual report.
(c)See Note D.21.1. to our consolidated financial statements, included at Item 18. of this annual report.
(d)These comprise irrevocable commitments to suppliers of (i) property, plant and equipment, net of down payments (see Note D.3. to our consolidated
financial statements included at Item 18. of this annual report) and (ii) goods and services.
(e)This line includes all milestone payments on projects regarded as reasonably possible, i.e. on projects in the development phase.
(f)See Note D.18. to our consolidated financial statements included at Item 18. of this annual report.
(g)See Note D.19.1. to our consolidated financial statements included at Item 18. of this annual report. The table above does not include ongoing annual
employer’s contributions to plan assets, estimated at €29 million for 2025.
We may have payments due to our current or former research and development partners under collaboration agreements.
These agreements typically cover multiple products, and give us the option to participate in development on a product-by-
product basis. When we exercise our option with respect to a product, we pay our collaboration partner a fee and receive
intellectual property rights to the product in exchange. We are also generally required to fund some or all of the development
costs for the products that we select, and to make payments to our partners when those products reach development
milestones.
We have entered into collaboration agreements under which we have rights to acquire products or technology from third parties
through the acquisition of shares, loans, license agreements, joint development, co-marketing and other contractual
arrangements. In addition to upfront payments on signature of the agreement, our contracts frequently require us to make
payments contingent upon the completion of development milestones by our alliance partner or upon the granting of approvals
or licenses.
Because of the uncertain nature of development work, it is impossible to predict (i) whether Sanofi will exercise further options for
products, or (ii) whether the expected milestones will be achieved, or (iii) the number of compounds that will reach the relevant
milestones. It is therefore impossible to estimate the maximum aggregate amount that Sanofi will actually pay in the future under
existing collaboration agreements.
Given the nature of its business, it is highly unlikely that Sanofi will exercise all options for all products or that all milestones will be
achieved.
SANOFI FORM 20-F 2025 | 81 |
PART I |
ITEM 5. Operating and Financial Review and Prospects |
The main collaboration agreements relating to development projects are described in Note D.21.1. to our consolidated financial
statements included at Item 18. of this annual report. Milestone payments relating to development projects under these
agreements included in the table above exclude projects still in the research phase (€13.9 billion in 2025, €14.4 billion in 2024)
and payments contingent upon the attainment of sales targets once a product is on the market (€15.6 billion in 2025, €15.2 billion
in 2024).
C. Research and development, patents and licenses, etc.
Our research and development teams utilize our deep expertise to contribute to the growth of our business. As of December 31,
2025, we had 9,274 employees engaged in research and development activities. In the years ended December 31, 2024 and 2025
we spent €7,394 million and €7,842 million, respectively, on research and development. For a discussion of our research and
development activities, see “Item 4. Information on the Company — B. Business Overview” and section “— A. Operating Results”
above.
D. Trend information
For a discussion of trends, see “Item 4. Information on the Company — Business Overview” and sections “— A. Operating Results”
and “— Liquidity and Capital Resources” above.
E. Critical accounting estimates
For a discussion of our critical accounting estimates, see Note A.3. to our consolidated financial statements included in Item 18. of
this annual report.
82 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Item 6. Directors, Senior Management and Employees
A. Directors and Senior Management
Since January 1, 2007, Sanofi has separated the offices of Chairman and Chief Executive Officer. Annual evaluations conducted
since that date have indicated that this governance structure is appropriate to Sanofi’s current configuration. When the term of
office of Serge Weinberg as Chairman ended and Frédéric Oudéa was appointed in May 2023, our Board of Directors decided to
continue separating the offices of Chairman and Chief Executive Officer. The Board believes this governance structure is still
appropriate to the current context in which Sanofi operates and its share ownership structure, as well as protecting the rights of
all of its stakeholders.
The Chairman organizes and directs the work of the Board, and is responsible for ensuring the proper functioning of the
corporate decision-making bodies in compliance with good governance principles. The Chairman coordinates the work of the
Board of Directors with that of its Committees. He ensures that the Company’s management bodies function properly, and in
particular that the directors are able to fulfill their duties. The Chairman is accountable to the Shareholders’ General Meeting,
which he chairs.
In addition to these roles conferred by law, the Chairman:
•in coordination with the Chief Executive Officer, liaises between the Board of Directors and the shareholders of the Company;
•is kept regularly informed by the Chief Executive Officer of significant events and situations affecting the affairs of the
Company, and may request from the Chief Executive Officer any information useful to the Board of Directors;
•may, in close collaboration with the Chief Executive Officer, represent the Company in high-level dealings with governmental
bodies and with key partners of the Company and/or of its subsidiaries, both nationally and internationally;
•seeks to prevent any conflict of interest and manages any situation that might give rise to a conflict of interest. He also gives
rulings, in the name of the Board, on requests to take up external directorships of which he may become aware or that may be
submitted to him by a director;
•may interview the statutory auditors in preparation for the work of the Board of Directors and the Audit Committee; and
•strives to promote in all circumstances the values and image of the Company.
The Chairman is also required to develop and maintain a proper relationship of trust between the Board and the Chief Executive
Officer, so as to ensure that the latter consistently and continuously implements the orientations determined by the Board.
In fulfilling his remit, the Chairman may meet with any individual, including senior executives of the Company, while avoiding any
involvement in directing the Company or managing its operations, which are exclusively the responsibility of the Chief Executive
Officer.
Finally, the Chairman reports to the Board on the fulfillment of his remit.
The Chairman carries out his duties during the entire period of his term of office, subject to the caveat that a director who is a
natural person may not be appointed or reappointed once that director has reached the age of 70.
The Chief Executive Officer manages the Company, and represents it in dealings with third parties within the limit of the
corporate purpose. The Chief Executive Officer has the broadest powers to act in all circumstances in the name of the Company,
subject to the powers that are attributed by law to the Board of Directors and to the Shareholders’ General Meeting and within
the limits set by the Board of Directors.
The Chief Executive Officer must be less than 65 years old. A proposed amendment to the Articles of Association will be
submitted to a shareholder vote at the Annual General Meeting of April 29, 2026, intended to raise the age limit applicable to a
Chief Executive Officer on the date of their appointment.
Limitations on the powers of the Chief Executive Officer set by the Board
The limitations on the powers of the Chief Executive Officer are specified in the Board Charter. Without prejudice to legal
provisions regarding authorizations that must be granted by the Board (regulated agreements, guarantees, divestments of equity
holdings or real estate, etc.), prior approval from the Board of Directors is required for transactions or decisions resulting in an
investment or divestment, or an expenditure or guarantee commitment, made by the Company and its subsidiaries, in excess of:
•a cap of €500 million (per transaction) for transactions, decisions or commitments pertaining to a previously approved
strategy; and
•a cap of €150 million (per transaction) for transactions, decisions or commitments not pertaining to a previously approved
strategy.
When such transactions, decisions or commitments give rise to installment payments to the contracting third party (or parties)
that are contingent upon future results or objectives, such as the registration of one or more products, attainment of the caps is
calculated by aggregating the various payments due from the signing of the contract up to and including the filing of the first
application for marketing authorization in the US or in Europe.
SANOFI FORM 20-F 2025 | 83 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Attainment of the above caps is also assessed after taking into account all commitments to make payments upon exercising a
firm or conditional option with immediate or deferred effect, and all guarantees or collateral to be provided to third parties over
the duration of such commitments.
The prior approval procedure does not apply to transactions and decisions that result in the signature of agreements that solely
involve subsidiaries and the Company itself.
Remit of the Board of Directors
The Board of Directors establishes the orientation of the Company’s activities and ensures that they are implemented, paying
due consideration to social and environmental issues. Subject to those powers expressly attributed to Shareholders’ General
Meetings and within the limits set by the corporate purpose, the Board addresses any issue of relevance to the proper conduct of
the Company’s affairs and, through its deliberations, settles matters concerning the Company.
French law, Articles of Association and Board Charter
The rules and operating procedures of our Board of Directors are defined by French law, by our Articles of Association, and by our
Board Charter (English language versions of which are reproduced in full as Exhibit 1.1 and Exhibit 1.2 to this annual report).
Our Board Charter describes the rights and obligations of Board members; the composition, role and operating procedures of the
Board of Directors and Board Committees; and the roles and powers of the Chairman and the Chief Executive Officer. It is
prepared in accordance with the French Commercial Code and our Articles of Association.
Composition of the Board of Directors
As of February 17, 2026, the Sanofi Board of Directors has 16 members, including 11 independent directors and two directors
representing employees.
43% of our Board members (excluding the two directors representing employees) are women. In accordance with Order no.
2024-934 of October 15, 2024 and the associated enabling decree no. 2025-744 of July 30, 2025 (which transposed into French
law Directive (EU) 2022/2381 of the European Parliament and of the Council of November 23, 2022), the rules relating to gender
balance on the Boards of listed companies apply solely to the cohort of directors comprising (i) ordinary directors and (ii)
directors representing employee shareholders (none of whom sit on our Board of Directors). Specific gender balance rules apply
to the cohort of directors representing employees but only where there are at least three such directors, which is not the case at
Sanofi.
50% of our Board members (including directors representing employees) were non-French nationals.
84 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
As of February 17, 2026 | Age | Nationality | Number of Sanofi shares held | Number of directorships in listed companies(a) | Date first appointed | End of current term of office (AGM) | Years of service on Board | Audit Committee | Appointments, Governance & CSR Committee | Compensation Committee | Strategy Committee | Scientific Committee | ||
CHAIRMAN | Frédéric Oudéa |  | 62 |  | 1,000 | 3 | 2023(b) | 2027 | 3 | ò | Í | ò | ||
CHIEF EXECUTIVE OFFICER | Paul Hudson |  | 58 |  | 211,825 (c) | 1 | 2019 | 2026 | 6 | ò | ||||
NON-INDEPENDENT DIRECTORS | Christophe Babule |  | 60 | | 1,000 | 1 | 2019 | 2026 | 6 | ò | ||||
Barbara Lavernos |  | 57 | | 1,000 | 2 | 2021 | 2029 | 4 | ò | ò | ||||
INDEPENDENT DIRECTORS | Clotilde Delbos |  | 58 | | 1,000 | 4 | 2024 | 2027 | 2 | ò | Í(d) | |||
Rachel Duan |  | 55 |  | 1,000 | 4 | 2020 | 2028 | 5 | ò | |||||
Carole Ferrand |  | 55 | | 1,000 | 2 | 2022 | 2029 | 3 | Í | |||||
Lise Kingo |  | 64 |  | 1,000 | 3 | 2020 | 2028 | 5 | ò | |||||
Jean-Paul Kress |  | 60 | | 1,000 | 1 | 2025 (e) | 2026 | 1 | ò | ò | ||||
Patrick Kron |  | 72 | | 1,000 | 3 | 2014 | 2026 | 11 | Í(f) | ò (d) | ò | |||
Anne-Françoise Nesmes |  | 54 | | 1,000 | 2 | 2024 | 2027 | 2 | ò | |||||
John Sundy |  | 64 |  | 1,000 | 1 | 2024 | 2027 | 2 | ò | |||||
Emile Vœst |  | 66 |  | 1,000 | 2 | 2022 | 2029 | 3 | ò | |||||
Antoine Yver |  | 68 |  | 1,000 | 2 | 2022 | 2029 | 3 | ò | Í | ||||
DIRECTORS REPRESENTING EMPLOYEES | Wolfgang Laux |  | 58 |  | See biography | 2 | 2021 | 2029 | 4 | ò | ||||
Humberto De Sousa |  | 48 | | See biography | 1 | 2025 | 2029 | 1 | ||||||
Í Chair ò Member
(a)Includes all directorships held in listed companies. The office held within Sanofi is included.
(b)Frédéric Oudéa was initially appointed as a non-voting director by the Board on September 2, 2022, and then appointed as a director by the Annual
General Meeting on May 25, 2023.
(c)Includes shares that vested in May 2023, May 2024 and May 2025 under the equity-based compensation plans of April 28, 2020 and April 30, 2021, and
May 3, 2022.
(d)Clotilde Delbos was appointed as Chair of the Compensation Committee with effect from April 30, 2025, replacing Patrick Kron who remains a member
of that Committee.
(e)Jean-Paul Kress was co-opted as a director by the Board of Directors meeting of December 19, 2024 with effect from January 1, 2025 (replacing Gilles
Schnepp, who resigned from office effective December 31, 2024); his co-option was ratified by the Annual General Meeting on April 30, 2025.
(f)Patrick Kron was appointed as Chair of the Appointments, Governance & CSR Committee with effect from January 1, 2025 on an interim basis until the
close of the Annual General Meeting of April 29, 2026 called to approve the financial statements for the year ended December 31, 2025.
SANOFI FORM 20-F 2025 | 85 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
In line with current legislation and given that less than 3% of our share capital is owned by our employees, Sanofi does not have a
director representing its employee shareholders.
Term of Office
The term of office of directors is four years. Directors are required to seek reappointment by rotation, such that members of the
Board are required to seek reappointment on a regular basis in the most equal proportions possible. Exceptionally, the
Shareholders’ Ordinary General Meeting may appoint a director to serve for a term of one, two or three years, in order to ensure
an adequate rotation of Board members. Each director standing down is eligible for reappointment. Should one or more
directorships fall vacant as a result of death or resignation, the Board of Directors may make provisional appointments in the
period between two Shareholders’ General Meetings, in accordance with applicable laws.
Directors may be removed from office at any time by a Shareholders’ General Meeting.
A natural person cannot be appointed or reappointed as a director once he or she reaches the age of 70. As soon as the number
of directors over the age of 70 represents more than one-third of the directors in office, the oldest director shall be deemed to
have resigned; his or her term of office shall end at the date of the next Shareholders’ Ordinary General Meeting.
Changes in the composition of the Board of Directors during 2024 and 2025
The table below shows changes in the composition of the Board of Directors during 2024 and 2025:
Annual General Meeting of April 30, 2024 | Other than at an Annual General Meeting (late 2024 / early 2025) | Annual General Meeting of April 30, 2025 | |
Expiry of term of office | Diane Souza Thomas Südhof | None | Fabienne Lecorvaisier Yann Tran |
Renewal of term of office | Rachel Duan Lise Kingo | None | Carole Ferrand Barbara Lavernos Emile Voest Antoine Yver |
New appointments | Clotilde Delbos Anne-Françoise Nesmes John Sundy | None | None |
Co-opted | None | Jean-Paul Kress (a) | Jean-Paul Kress (a) |
Other | None | Gilles Schnepp (b) | None |
(a)Jean-Paul Kress was co-opted as a director by the Board of Directors meeting of December 19, 2024 with effect from January 1, 2025 (replacing Gilles
Schnepp, who resigned from office effective December 31, 2024); his co-option was ratified by the Annual General Meeting on April 30, 2025.
(b)Gilles Schnepp resigned from office as a director effective December 31, 2024.
Changes in Board membership to be submitted for shareholder approval at the Annual General
Meeting on April 29, 2026
Expiry of term of office | Paul Hudson, Patrick Kron |
Renewal of term of office | Christophe Babule, Jean-Paul Kress |
Proposed new appointments | Belén Garijo, Christel Heydemann |
Other | None |
86 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
The terms of office of Paul Hudson, Christophe Babule, Jean-Paul Kress and Patrick Kron will expire at the close of the Annual
General Meeting to be held on April 29, 2026. The Appointments, Governance and CSR Committee meeting recommended the
renewal of the terms of office of Christophe Babule and Jean-Paul Kress. Draft resolutions to be submitted for shareholder
approval at the Annual General Meeting on April 29, 2026 will be approved by the Board of Directors in March 2026, and will be
communicated in the Notice of Meeting. As things stand, however it is not proposed to renew Paul Hudson' term of office (see
"Item 8. Financial Information — Other Changes") nor Patrick Kron's term of office, given that he would by then have served as a
director of Sanofi for 12 years and hence would no longer be considered as independent under the AFEP-MEDEF Code, and the
Annual General Meeting will be asked to:
•renew the terms of office of:
–Christophe Babule – refer to “— Detailed Information about Members of the Board of Directors” for his biographical details,
and to “— Competencies of Board Members” below for details of what he brings to the Board; and
–Jean-Paul Kress – refer to “— Detailed Information about Members of the Board of Directors” for her biographical details,
and to “— Competencies of Board Members” below for details of what he brings to the Board;
• appoint two new directors, who would bring the following competencies to the Board:
–Belén Garijo: scientific training, healthcare/pharmaceutical industry experience, senior executive role in international
groups, directorship in international groups, international experience, mergers & acquisitions, sustainable development,
digitalization/AI implementation,
–Christel Heydemann: senior executive role in international groups, directorship in international groups, international
experience, mergers & acquisitions, sustainable development, digitalization/AI implementation.
Rules relating to the composition of the Board and its Committees
Each year, the Board of Directors conducts a review to ensure that there is an appropriate balance in its composition and in the
composition of its Committees. In particular, the Board seeks gender balance and a broad range of competencies, experiences,
nationalities and ages, reflecting our status as a diversified global business. The Board investigates and evaluates not only
potential candidates, but also whether existing directors should seek reappointment. Above all, the Board seeks directors who
show independence of mind and are competent, dedicated and committed, with compatible and complementary personalities.
Acting on proposals from the Chief Executive Officer and in liaison with the Appointments, Governance and CSR Committee, the
Board seeks to implement the AFEP-MEDEF recommendation and forthcoming applicable French rules on gender representation
in Sanofi’s executive bodies, and more generally by bringing a breadth of diverse experiences, backgrounds and expertise to
Sanofi's executive bodies, and across the Company. That commitment to non-discrimination, fairness and inclusion is included in
our Play to Win strategy. As of December 31, 2025, 25% of our 12 Executive Committee members were women, and 58% were
non-French nationals.
The Board of Directors is also kept informed, in particular during its annual discussion on its equal opportunity and equal pay
policy, on how Sanofi’s inclusion and representation policy is cascaded down to “Senior Leaders” and “Executives” (the positions
in Sanofi with the highest level of responsibility).
Competencies of Board members
The Board of Directors, in liaison with the Appointments, Governance and CSR Committee, must ensure that the composition of
the Board is balanced, diverse and fit for purpose.
In assessing its composition, the Board takes account of the new challenges facing Sanofi and our corporate strategy, and
determines whether the qualities and skills of serving directors are sufficient for the Board to deliver on its remit.
In parallel, as part of its work the Appointments, Governance and CSR Committee keeps track of competencies among Board
members. In December 2025, the Committee conducted a detailed review of the matrix of competencies; competencies
reported by each director were evaluated by the Committee, and the final matrix was signed off by the Board of Directors. This
shows that in recent years, the Board has adapted its composition by bringing in additional scientific expertise and maintaining
the level of other key competencies, especially in finance and accounting.
SANOFI FORM 20-F 2025 | 87 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
The matrix below, based on the composition of the Board as of February 17, 2026, shows a complete and balanced spread of the
types of competencies required, both in general terms and by reference to our strategic ambitions (the matrix shows the number
of directors possessing each of those competencies). The detailed information about individual Board members presented in
“— Detailed information about Board members” below aligns with the competencies summarized in the matrix.
Scientific training | Healthcare/ pharmaceutical industry experience | Senior executive role in international group | Directorship in international group | International experience | Mergers & Acquisitions | Finance/ Accounting | Sustainable development | Digitalization/ IA implementation | |
 |  |  |  |  |  |  |  |  | |
Frédéric Oudéa | l | l | l | l | l | l | l | ||
Paul Hudson | l | l | l | l | l | l | |||
Christophe Babule | l | l | l | l | l | l | |||
Clotilde Delbos | l | l | l | l | l | l | |||
Humberto de Sousa | l | l | l | ||||||
Rachel Duan | l | l | l | l | l | l | l | ||
Carole Ferrand | l | l | l | l | l | l | |||
Lise Kingo | l | l | l | l | l | l | |||
Jean-Paul Kress | l | l | l | l | l | l | l | ||
Patrick Kron | l | l | l | l | |||||
Wolfgang Laux | l | l | l | l | |||||
Barbara Lavernos | l | l | l | l | l | ||||
Anne-Françoise Nesmes | l | l | l | l | l | l | l | ||
John Sundy | l | l | l | l | l | ||||
Emile Vœst | l | l | l | l | l | ||||
Antoine Yver | l | l | l | l | |||||
% COMPETENCY SCORE | 31% | 63% | 75% | 56% | 94% | 69% | 44% | 50% | 69% |
Director Training
In 2025, Board members received four training modules delivered by in-house and/or external specialists, dealing with the
following key issues:
•Key principles of immunology: brief history of immunology, nature and function of the immune system, plus case studies and
real-life examples of how Sanofi medicines and vaccines are used.
•European Union regulatory framework: overview of EU institutions, description of European Commission priorities, review of
key European texts governing the pharmaceutical industry (pricing/terms of reimbursement, evaluation of healthcare
technologies, clinical trials), and an analysis of Sanofi's position in relation to European regulations and institutions.
•Equitable access to healthcare: summary of key issues around equitable access to healthcare, description of access barriers in
low-to-middle income countries or in low-income populations, outline of levers for pharmaceutical companies to improve
access.
•Artificial Intelligence (AI) in the biopharma sector: history and development of the various types of AI (generative, agentic and
physical), and current trends; overview of general-use cases for agentic AI, potential for rollout in biopharma (R&D, operations,
information technology, support functions, etc.); comparison with industry peers.
The training plan for 2026 was agreed upon by the Board of Directors on February 11, 2026, and will include modules on the
alliance with Regeneron; the impacts of GLP-1 drugs; healthcare insurance around the world (public and private); and in CSR,
climate and nature related risks and opportunities, resilience, and the impacts on Sanofi.
Independence of Board Members
Under the terms of the AFEP-MEDEF Code, a director is independent when he or she has no relationship of any kind whatsoever
with the Company, its group or its senior management that may color his or her judgment. More specifically, a director can only
be regarded as independent if he or she:
•is not (and has not been during the past five years):
–an employee or executive officer of the Company,
–an employee, executive officer or director of an entity consolidated by the Company, or
–an employee, executive officer or director of the Company’s parent, or of an entity consolidated by that parent (criterion 1);
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ITEM 6. Directors, Senior Management and Employees |
•is not an executive officer of an entity in which (i) the Company directly or indirectly holds a directorship or (ii) an employee of
the Company is designated as a director or (iii) an executive officer of the Company (currently, or within the past five years)
holds a directorship (criterion 2);
•is not a customer, supplier, investment banker or corporate banker that is material to the Company or its group, or for whom
the Company or its group represents a significant proportion of its business (criterion 3);
•has no close family ties with a corporate officer of the Company (criterion 4);
•has not acted as an auditor for the Company over the course of the past five years (criterion 5);
•has not been a director of the Company for more than 12 years (criterion 6);
•does not receive variable compensation in cash or in the form of shares or any compensation linked to the performance of the
Company or its group (criterion 7); or
•does not represent a shareholder that has a significant or controlling interest in the Company (criterion 8).
The influence of other factors such as the ability to understand challenges and risks, and the courage to express ideas and form a
judgment, is also evaluated before it is decided whether a director can be regarded as independent.
In accordance with our Board Charter and pursuant to the AFEP-MEDEF Code, the Board of Directors’ meeting of February 11,
2026 discussed the independence of the current directors. Of the 16 directors in office on that date, 11 were deemed to be
independent directors by reference to the independence criteria used by the Board of Directors pursuant to the AFEP-MEDEF
Code: Frédéric Oudéa, Clotilde Delbos, Rachel Duan, Carole Ferrand, Lise Kingo, Jean-Paul Kress, Patrick Kron, Anne-Françoise
Nesmes, John Sundy, Emile Voest and Antoine Yver.
In accordance with the rules described above, Paul Hudson (who is an executive officer of Sanofi until end-of-day on February 17,
2026), and Barbara Lavernos and Christophe Babule (who were appointed on the recommendation of L’Oréal, a major
shareholder of Sanofi), are not deemed independent.
Consequently, as of February 17, 2026 the proportion of independent directors is 79%. This complies with the AFEP-MEDEF
recommendation of at least 50% in companies with dispersed ownership and no controlling shareholder (which is the case for
Sanofi). In accordance with the recommendations of the AFEP-MEDEF Code, directors representing employees are excluded
when calculating the proportion of independent directors.
Frédéric Oudéa | Paul Hudson | Christophe Babule (a) | Clotilde Delbos | Rachel Duan | Carole Ferrand | Lise Kingo | Jean-Paul Kress | Patrick Kron | Barbara Lavernos | Anne-Françoise Nesmes | John Sundy | Emile Voest | Antoine Yver | |
Criterion 1: employee/executive officer in past 5 years | l | X | l | l | l | l | l | l | l | l | l | l | l | l |
Criterion 2: cross-directorships | l | l | l | l | l | l | l | l | l | l | l | l | l | l |
Criterion 3: significant business relationship | l | l | l | l | l | l | l | l | l | l | l | l | l | l |
Criterion 4: close family ties | l | l | l | l | l | l | l | l | l | l | l | l | l | l |
Criterion 5: auditor | l | l | l | l | l | l | l | l | l | l | l | l | l | l |
Criterion 6: held office for > 12 years | l | l | l | l | l | l | l | l | l | l | l | l | l | l |
Criterion 7: non-executive director in receipt of variable or performance-linked compensation | l | l | l | l | l | l | l | l | l | l | l | l | l | l |
Criterion 8: significant shareholder | l | l | X | l | l | l | l | l | l | X | l | l | l | l |
Deemed independent | YES | NO | NO | YES | YES | YES | YES | YES | YES | NO | YES | YES | YES | YES |
lIndependence criterion met X Independence criterion not met
(a)This table only refers to independence as defined under the AFEP-MEDEF Code. However, Christophe Babule is independent for the purposes of the
NASDAQ Listing Rules and Rule 10A-3 under the Exchange Act.
Failure to fulfil one of the criteria does not automatically disqualify a director from being independent.
In assessing the criterion related to significant business relationships (criterion 3), the Board of Directors took into account the
various relationships between directors and Sanofi and concluded that there was no relationship of a kind that might undermine
their independence. The Board of Directors noted that the Company and its subsidiaries had, in the normal course of business,
over the past three years, sold products and provided services to, and/or purchased products and received services from,
companies in which certain of the Company's directors, who are classified as independent (or their close family members) were
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ITEM 6. Directors, Senior Management and Employees |
senior executives or employees during 2025. In each case, the amounts paid to or received from such companies in the recent
years were determined on an arm's length basis and not at amounts that the Board regarded as undermining the independence
of the directors in question.
Selection process for Board members
The Appointments, Governance and CSR Committee has a remit to organize a procedure for selecting future directors. Once the
desired profile and skillset for a new director has been defined, a search for potential candidates is conducted by external
consultants.
Once a shortlist has been established, the Committee interviews two or three candidates. The candidates also meet with the
Chairs of the other Board committees, and in some cases the other Committee members as well. In all cases, they meet with the
Chairman of the Board of Directors and the Chief Executive Officer. After completing the interviews, the Committee makes a
recommendation to the Board on the candidate with the best fit for the profile, supporting that recommendation with an
explanation of how the interviews were conducted and giving reasons why a candidate was selected. Before recommending a
candidate to the Board, the Committee obtains assurance as to their availability, in particular as regards any other executive
posts or offices the candidate may hold.
Overview of selection process for Board members
Definition of profile and skillset | Pre-selection | Selection | Appointment | |||||||||
Independent directors | Appointments, Governance & CSR Committee defines the profile and skillset | Appointments, Governance & CSR Committee pre-selects three potential candidates from a long- list suggested by an external consultant | Some or all Committee members interviews two or three short-listed candidates | Appointments, Governance & CSR Committee recommends a candidate, and explains the reasons for its recommendation | ||||||||
Directors representing employees | •One Director representing employees is designated by the trade union body which is the most representative, in the Company and those of its direct or indirect subsidiaries that have their registered office in French territory, •One Director representing employees is designated by the European Works Council | |||||||||||
Succession planning
General principles
The remit of the Appointments, Governance and CSR Committee includes preparing for the future of the Company’s executive
bodies, in particular through the establishment of a succession plan for each of the executive officers, i.e., separate succession
plans for the Chief Executive Officer and the Chairman of the Board.
Those plans are reviewed at meetings of the Appointments, Governance and CSR Committee, and address various scenarios:
•unplanned vacancy due to prohibition, resignation or death;
•forced vacancy due to poor performance, mismanagement or misconduct; and
•planned vacancy due to retirement or expiration of term of office.
Through its work and discussions, the Committee seeks to devise succession plans that are adaptable to situations arising in the
short, medium or long term, but which also build in diversity – in all its facets – as a key factor.
To fulfill its remit, the Appointments, Governance and CSR Committee:
•provides the Board with progress reports, in particular at executive sessions;
•co-ordinates with the Compensation Committee. A director sitting both committees is beneficial for coordination purposes;
•works closely with the Chief Executive Officer to (i) ensure succession plans are consistent with the Company’s own practices
and market practices, (ii) ensure high-potential internal prospects receive appropriate support and training, and (iii) check
there is adequate monitoring of key posts likely to fall vacant;
•meets key executives on an ad hoc basis; and
•involves the Chairman and the Chief Executive Officer insofar as each has a key role in planning for his own successor, though
without them directing the process.
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ITEM 6. Directors, Senior Management and Employees |
In fulfilling their remit, Committee members are acutely conscious of confidentiality issues.
Although the Committee is aware that separating the offices of Chairman and Chief Executive Officer provides continuity of
power, it nonetheless assesses the situation of the Chairman of the Board as well as that of the executive team. Emergency
succession planning for the Chairman of the Board, and solutions for a smooth transition to the appointment of a new Chairman
should the need arise, were reviewed by the Appointments, Governance and CSR Committee at its meeting of February 4, 2026.
Succession planning for the Chief Executive Officer
Succession planning for the post of Chief Executive Officer relied on work initiated in mid-2024 with a systematic analysis of
potential candidates, both internal and external. The Appointments, Governance and CSR Committee reviewed the findings of
that analysis, and identified potential candidates in a very short time horizon, alongside others considered to be potentially ready
for the role in a three-to-five-year time horizon. In addition, a number of young high-potential individuals were identified for a
five-to-ten-year time horizon.
That process was updated towards the end of 2025. From October 2025, the Appointments, Governance and CSR Committee
produced a recommendation on the required profile for potential successors, which was approved by the Board. The Committee
also updated the list of potential internal candidates, and retained a new external consultant to take a second look at the list of
potential external candidates. Based on the needs identified by the Committee (and adopted by the Board), in terms of both their
expertise and their leadership profile, the Committee finalized a shortlist of candidates and held individual interviews with each of
them.
The Committee met in January 2026 and unanimously recommended that the Board meet with Belén Garijo, whose profile
offered the best fit with the expectations expressed. The Board first spoke with Paul Hudson, at its meeting on January 28, 2026,
about his ambitions to potentially renew his term of office, and then interviewed Belén Garijo in executive session on
February 7, 2026. At its meeting of February 10, 2026, the Committee discussed the matter and prepared a recommendation to
the Board that Belén Garijo be appointed as Chief Executive Officer to succeed Paul Hudson. That recommendation was based
mainly on her profile in an international executive role with a listed company; her acknowledged expertise and strategic vision in
the pharmaceutical industry; her broad range of experience, in particular her many years in research and development; the
success she had achieved in the 15 years of her career spent at Sanofi; her capacity to step up the pace and quality of execution
of Sanofi's strategy, and hence steer the business through its next growth cycle; and finally, her ability to bring rigour and
discipline to the management of deep, value-creating transformations.
Evaluation of the Board and its Committees
Under the terms of the Board Charter, and in accordance with the AFEP-MEDEF Code, a discussion of the operating procedures
of the Board and its committees must be included on the agenda of one Board meeting every year. The Charter also requires a
formal evaluation to be performed at least every three years under the direction of the Appointments, Governance and CSR
Committee, with assistance from an independent external consultant.
Since 2023 the evaluation procedure has included one-on-one interviews with each director (including the Chief Executive
Officer), intended to measure the contribution of each director to the work of the Board and its committees and to record any
suggestions they may have.
In practice, even in years when the three-yearly formal evaluation procedure (assisted by an independent external consultant) is
not conducted, the Board conducts an annual internal evaluation using a detailed questionnaire sent to directors by the
Secretary to the Board, and covering the composition and the operation of the Board and its committees. The responses (which
are confidential) are analyzed by the Secretary to the Board. A summary is then presented and discussed at a meeting of the
Appointments, Governance and CSR Committee; a detailed report finalized at that meeting is submitted to a Board meeting for
discussion at the start of the following year.
The last formal evaluation supported by a specialist consultancy firm was conducted under the direction of the Appointments,
Governance and CSR Committee in 2024.
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ITEM 6. Directors, Senior Management and Employees |
Evaluation of the Board and its Committees in 2024 - Formal evaluation with assistance from an external
consultant
In late 2024 and early 2025, a formal evaluation was conducted under the direction of the Appointments, Governance and CSR
Committee, with assistance from a specialist consultancy firm. Various actions have been implemented to address the areas of
progress and vigilance identified in that evaluation:
Areas of progress and vigilance identified in 2024 evaluation | Actions implemented in 2025 |
Further reinforcement of oversight of the transformation of R&D, including use of AI | In 2025, strategy seminars provided an opportunity for Board members to scrutinize R&D governance at Sanofi, and the ongoing transformation of the R&D function. In addition, Board members received a training module on the impacts and challenges around the use of AI in the biopharma sector, providing directors with relevant, up-to-date insights to enhance their review processes and the quality of their oversight over these major transformations. |
Oversight of capital allocation, and progress on Business Development/ M&A strategy | The Board-level strategy seminar provided a forum for collective, in-depth thinking about long-term capital allocation priorities. From an operational perspective, the Board carried out an overhaul of the governance arrangements for Business Development and M&A, instigating a non-binding offer approval process, including thresholds geared to transaction size and formalizing the role of the Scientific Committee in decision-making. |
Review of US operations | Directors had the opportunity to review Sanofi's US operations, including monitoring of the most favored nation (MFN) policy and signature of a voluntary agreement with the US administration, updates on tariffs and the supply chain situation, and mitigation plans to address political and commercial risks. |
Strategy in China | The Board enhanced its strategic oversight of China by leveraging on the field trip made in December 2024, and a review of the report issued by the Scientific Committee on March 19, 2025. In response to China's repositioning towards leading-edge innovation, combined with the growing importance of China within Sanofi's external innovation portfolio, the Board signed off on an approach based on controlled integration with the local ecosystem. |
In-depth review of succession planning and talent management | In 2025, the Appointments, Governance and CSR Committee carried out in-depth work on succession planning and talent management, with support from the Chief People Officer and an external recruitment consultancy firm. This gave Board members an opportunity for detailed scrutiny of potential successors for the CEO role, alongside related development plans to be rolled out over various time horizons from the short to the long term. The Board also reviewed emergency succession plans for the Chairman of the Board and for Patrick Kron, further enhancing corporate governance in terms of executive continuity. |
Expanded training program for Board members, with at least three sessions to address (i) status of and trends in the US market, (ii) key principles of immunology, and (iii) equitable access to healthcare | Building on the training program initiated in 2024, Board members received training during 2025 on the topics identified in the 2024 evaluation (refer to "—Director Training" above). |
Evaluation of the Board and its Committees in 2025 - Internal evaluation
In late 2025, an internal evaluation was conducted under the direction of the Appointments, Governance and CSR Committee,
based on a detailed questionnaire sent to each director. Each director was then provided with transcripts and a comprehensive
summary of the responses, based on which the Chairman conducted individual interviews with each director. Those interviews
took place in early 2026, providing an opportunity to assess the most important areas for improvement, prepare the Board
program for the coming year for approval, and provide individual feedback on the contributions of Board members.
The functioning of the Board was seen as improving, with no aspect regarded as having deteriorated year-on-year. In particular,
the transparency provided by external audits of the development pipeline and digital transformation was appreciated by the
Board as giving insights into Sanofi's progress in these two areas. The Board reaffirmed its keenness to focus its program even
more closely on key strategic issues and on R&D topics.
From that perspective, the contribution of certain committees to the work of the Board could nevertheless be improved. In
particular, the Scientific Committee could strengthen its oversight of R&D governance and productivity, and its contribution to
identifying long-term scientific opportunities, as part of more transparent dialogue with the R&D team. The Strategy Committee
could aim to achieve balance in its program between business development and M&A on the one hand, and longer- term thinking
around issues such as the impact of demographic factors and longevity, trends in the various markets in which the
pharmaceutical industry operates, and monitoring of the competitive landscape. The other committees were judged to be
functioning satisfactorily.
The areas of progress identified for 2026, in line with those identified in 2025, are:
•strengthening of R&D governance and productivity;
•capital allocation policy;
•oversight of digital transformation and the rollout of artificial intelligence;
•monitoring of implementation of Sanofi's strategy in China; and
•talent development and succession planning.
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ITEM 6. Directors, Senior Management and Employees |
The composition and size of the Board were regarded as appropriate. It was acknowledged that Sanofi has a relatively high
number of Board members compared to its peers, largely as a result of the presence of two employee representatives in
compliance with French legislation. Strengthening the Board's competencies in artificial intelligence and digital transformation, in
particular those relevant to the pharmaceutical sector, could be considered in the years ahead, along with a desire to marginally
reduce the size of the Board.
The Committee and the Board will continue to monitor diversity metrics, including on gender diversity, and will ensure that Sanofi
continues to meet its legal obligations.
Detailed information about Board members in office as of February 17, 2026
The following pages provide key information about each director individually:
•directorships and appointments held during 2025 (directorships in listed companies are indicated by an asterisk, and each
director’s principal position is indicated in bold);
•other directorships held during the last five years; and
•training and professional experience.
SANOFI FORM 20-F 2025 | 93 |
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ITEM 6. Directors, Senior Management and Employees |
Frédéric Oudéa | |
| Date of birth: July 3, 1963 |
Nationality: French | |
First appointed: May 2023 | |
Term expires: 2027 | |
Business address: Sanofi – 46, avenue de la Grande Armée – 75017 Paris – France | |
Number of shares held: 1,000 | |
Current directorships and appointments | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
Chairman of the Board of Directors | In French companies | |
•Chairman of the Strategy Committee •Member of the Appointments, Governance and CSR Committee •Member of the Scientific Committee | •Lead Independent Director of Capgemini * •Chairman of the Board of Directors of Revolut Western Europe •Director of Sienna Investment Managers SA •Member of the Supervisory Board of Sonic Topco, simplified joint stock company (société par actions simplifiée) | |
Chairman of Foundation S | In foreign companies | |
•Member of the Supervisory Board of Umicore * (Belgium) | ||
Past directorships expiring within the last five years | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
•None | In French companies | |
•Board member of ALD Automotive * | ||
In foreign companies | ||
•None | ||
Education and professional experience | ||
•Graduate of ENA (École Nationale d'Administration) •Degree from École Polytechnique | ||
Since 2023 | Sanofi * : •Chairman of the Board of Directors of Sanofi (May 2023) | |
Senior Executive Advisor of Bruxelles Lambert Group * (November 2023) | ||
1995-2023 | Société Générale * : •Chief Executive Officer of Société Générale (2015-2023) •Chief Executive Officer and Chairman of the Board of Société Générale (2009-2015) •Chief Executive Officer of Société Générale (2008-2009) •Group Chief Financial Officer of Société Générale (2003-2008) •Deputy Group Chief Financial Officer of Société Générale (2002-2003) •Head of global supervision and development of the Equity Department of Société Générale (1998-2002) •Assistant Manager, then Manager of the Corporate Banking department in London at Société Générale (1995-1998) | |
1987-1995 | French Ministry of Economy and Finance : •Various positions within the French Civil Service (General Inspectorate of Finance Service, Ministry of the Economy and Finance, Ministry of the Budget, Office of the Minister of Budget and Communication) | |
* Listed company.
94 | SANOFI FORM 20-F 2025 |
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ITEM 6. Directors, Senior Management and Employees |
Paul Hudson | |
| Date of birth: October 14, 1967 |
Nationality: British | |
First appointed: September 2019 | |
Last reappointment: May 2022 | |
Term expires: 2026 | |
Business address: Sanofi – 46, avenue de la Grande Armée – 75017 Paris – France | |
Number of shares held: 211,825 | |
Current directorships and appointments | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
Chief Executive Officer | In French companies | |
•Director •Member of the Strategy Committee | •None | |
In foreign companies | ||
•None | ||
Past directorships expiring within the last five years | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
•None | In French companies | |
•None | ||
In foreign companies | ||
•None | ||
Education and professional experience | ||
•Degree in economics from Manchester Metropolitan University, UK | ||
•Diploma in marketing from the Chartered Institute of Marketing, UK | ||
•Honorary Doctorate in Business Administration, Manchester Metropolitan University, UK | ||
2019-2026 | Chief Executive Officer of Sanofi * | |
2016-2019 | CEO of Novartis Pharmaceuticals *, member of Executive Committee | |
2006-2016 | Various operational and managerial positions at AstraZeneca * (including President, AstraZeneca US; Executive Vice President, North America; Representative Director & President, AstraZeneca KK, Japan; President of AstraZeneca Spain; and Vice-President and head of Primary Care United Kingdom) | |
Before 2006 | Various operational and managerial positions at Schering-Plough, including Head of Global Marketing for biologicals. Various sales and marketing positions at GlaxoSmithKline* UK and Sanofi-Synthélabo UK | |
* Listed company.
SANOFI FORM 20-F 2025 | 95 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Christophe Babule | |
| Date of birth: September 20, 1965 |
Nationality: French | |
First appointed: February 2019 | |
Last reappointment: May 2022 | |
Term expires: 2026 | |
Business address: Sanofi – 46, avenue de la Grande Armée – 75017 Paris – France | |
Number of shares held: 1,000 | |
Current directorships and appointments | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
Director | In French companies | |
•Member of the Audit Committee | •Director of the “L'Oréal Fund for Women” charitable endowment fund | |
In foreign companies | ||
•None | ||
Past directorships expiring within the last five years | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
•None | In French companies | |
•None | ||
In foreign companies | ||
L'Oréal *Group : | ||
•Director of L'Oréal USA Inc. (United States) | ||
Education and professional experience | ||
•MBA, HEC School of Management | ||
Since February 2019 | Chief Financial Officer at L'Oréal * | |
Since 1988 | Various positions within the L’Oréal* Group, including as Director of Administration & Finance for China, then Mexico; Director of Internal Audit; and Director of Administration & Finance for the Asia Pacific Zone | |
* Listed company.
96 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Clotilde Delbos | |
| Date of birth: September 30, 1967 |
Nationality: French | |
First appointed: April 2024 | |
Term expires: 2027 | |
Business address: Sanofi - 46, avenue de la Grande Armée - 75017 Paris - France. | |
Number of shares held: 1,000 | |
Current directorships and appointments | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
Independent director | In French companies | |
•Chairwoman of the Compensation Committee •Member of the Audit Committee | •Director of AXA * •Director of Alstom * (Chairwoman of the Audit and Risks Committee) •Director of Schneider Electric * •Co-gérant of Hactif Patrimoine •President of Hactif Advisory | |
In foreign companies | ||
•None | ||
Past directorships expiring within the last five years | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
•None | In French companies | |
•President of RCI Banque SA •President of Renault Venture Capital •President of Renault Mobility as an Industry | ||
In foreign companies | ||
•Director of Renault Espana | ||
Education and professional experience | ||
•MBA EM Lyon in Finance and Accounting | ||
Since 2024 | Treasurer of the French Rugby Federation, Member of the Executive Committee of the French National Rugby League, and Member of the World Rugby Council. | |
2012 - 2022 | Various positions at Renault Group * including Group Chief Financial Officer, Chairwoman of the Board of Directors of RCI Banque, Interim Chief Executive Officer of Renault SA, Deputy Chief Executive Officer of the Renault group and Chief Executive Officer of Mobilize. | |
Before 2012 | Various positions in Internal Audit, Mergers & Acquisitions and Treasury, including at PricewaterhouseCoopers and Pechiney. | |
* Listed company.
SANOFI FORM 20-F 2025 | 97 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Humberto De Sousa | |
| Date of birth: September 28, 1977 |
Nationality: French | |
First appointed: April 2025 | |
Term expires: 2029 | |
Business address: Sanofi – 46, avenue de la Grande Armée – 75017 Paris – France | |
Number of shares held: 10 American Depositary Receipts equivalent to 5 shares, 10 ordinary shares and 137 FCPE shares | |
Current directorships and appointments | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
Director representing employees | In French companies | |
•None | ||
In foreign companies | ||
•None | ||
Past directorships expiring within the last five years | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
•None | In French companies | |
•None | ||
In foreign companies | ||
•None | ||
Education and professional experience | ||
•STI Baccalaureate (Baccalauréat STI) in Electrical Engineering | ||
Since 2018 | Group Maintenance Coordinator, Sanofi Group * | |
2013-2025 | Employee representative, CFDT Union | |
2007-2018 | Maintenance/Service technician, Sanofi Group * | |
1999-2000 | Maintenance/Service technician, Rhône Poulenc | |
* Listed company.
98 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Rachel Duan | |
| Date of birth: July 25, 1970 |
Nationality: Chinese | |
First appointed: April 2020 | |
Last reappointment: April 2024 | |
Term expires: 2028 | |
Business address: Sanofi – 46, avenue de la Grande Armée – 75017 Paris – France | |
Number of shares held: 1,000 | |
Current directorships and appointments | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
Independent director | In French companies | |
•Member of the Compensation Committee | •Director of Kering * | |
In foreign companies | ||
•Director of HSBC * | ||
•Director of Adecco Group * | ||
Past directorships expiring within the last five years | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
•None | In French companies | |
•Director of AXA * | ||
In foreign companies | ||
•None | ||
Education and professional experience | ||
•MBA, University of Wisconsin-Madison (United States) | ||
•Bachelor’s degree in Economics and International Trade, Shanghai International Studies University (China) | ||
Since March 2024 | Independent Director, Kering * | |
Since September 2021 | Independent Director, HSBC * | |
Since April 2020 | Independent Director, Adecco Group * | |
2018-2024 | Independent Director, AXA * | |
1996-2020 | Senior Vice President of General Electric * (United States) and President & CEO of GE Global Markets (China) | |
* Listed company.
SANOFI FORM 20-F 2025 | 99 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Carole Ferrand | |
| Date of birth: April 2, 1970 |
Nationality: French | |
First appointed: May 2022 | |
Last reappointment: April 2025 | |
Term expires: 2029 | |
Business address: Sanofi – 46, avenue de la Grande Armée – 75017 Paris – France | |
Number of shares held: 1,000 | |
Current directorships and appointments | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
Independent director | In French companies | |
•Chairwoman of the Audit Committee | •Honorary President and Director of Terra Nova (non-profit association) •Director and member of the Commitments Committee of France Télévisions •CEO of Galeries Lafayette Services SAS •CEO of Motier Invest SAS, Motier Ventures 2024 SAS, Motier Ventures 2025 SAS and Motier Ventures 2027 SAS •Representative of Société Anonyme des Galeries Lafayette on the Board of Directors of Lafayette Anticipations (Foundation) | |
In foreign companies | ||
•None | ||
Past directorships expiring within the last five years | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
•None | In French companies | |
•Director and Chair of the Audit Committee of Fnac Darty * •Member of the Executive Committee of June 21 SAS •President of Capgemini Ventures SAS | ||
In foreign companies | ||
•Substitute of Alain de Marcellus, Capgemini Brasil SA (Brazil) •Director of Capgemini Solutions Canada Inc. •Director of Capgemini UK plc •Director of CGS Holdings Ltd (United Kingdom) •Director of Capgemini Espana SL (Spain) •Director of Altran Innovacion SLU (Spain) | ||
Education and professional experience | ||
•HEC School of Management, Master's degree | ||
Since 2024 | Head of Strategy and Development of Motier Holding | |
2018 - 2023 | Chief Financial Officer of Capgemini * | |
2013-2018 | Financing Operations Director of Groupe Artémis | |
2011-2012 | Chief Financial Officer of EuropaCorp | |
2000-2011 | Chief Financial Officer and General Counsel of Sony France | |
1992-2000 | Audit and Transaction Services at PricewaterhouseCoopers (PwC) | |
* Listed company.
100 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Lise Kingo | |
| Date of birth: August 3, 1961 |
Nationality: Danish | |
First appointed: April 2020 | |
Last reappointment: April 2024 | |
Term expires: 2028 | |
Business address: Sanofi – 46, avenue de la Grande Armée – 75017 Paris – France | |
Number of shares held: 1,000 | |
Current directorships and appointments | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
Independent director | In French companies | |
•Member of the Appointments, Governance & CSR Committee | •Director of Danone * | |
In foreign companies | ||
•Member of the Supervisory Board of Covestro AG * (Germany) •Director of Allianz Trade | ||
Past directorships expiring within the last five years | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
•None | In French companies | |
•None | ||
In foreign companies | ||
•Independent Director, Aker Horizons ASA * (Norway) •Member of the Advisory Panel for Humanitarian and Development Aid Coordination, Novo Nordisk Foundation (Denmark) | ||
Education and professional experience | |||
•Master’s degree in Responsibility & Business, University of Bath (United Kingdom) | |||
•Bachelor’s degree in Marketing and Economics, Copenhagen Business School (Denmark) | |||
•Bachelor’s degree in Religions and Ancient Greek Art, University of Aarhus (Denmark) | |||
•Director Certification, INSEAD (France) | |||
Since 2022 | Independent director of Danone * | ||
Since 2021 | Independent director of Covestro AG * (Germany) | ||
2021-2023 | Independent Director, Aker Horizons ASA * (Norway) | ||
2015-2020 | CEO & Executive Director of United Nations Global Compact (US) | ||
2002-2014 | Executive Vice President Corporate Relations & Chief of Staff at Novo Nordisk A/S (Denmark) | ||
1999-2002 | Senior Vice President, Stakeholder Relations at Novo Holding (Denmark) | ||
1988-1999 | Director, Environmental Affairs of Novozymes (Denmark) | ||
* Listed company.
SANOFI FORM 20-F 2025 | 101 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Jean-Paul Kress | |
| Date of birth: August 1, 1965 |
Nationality: French | |
First appointed (co-optation): January 1, 2025 | |
Term expires: 2026 | |
Business address: Sanofi – 46, avenue de la Grande Armée – 75017 Paris – France | |
Number of shares held: 2,000 American Depositary Receipts, equivalent to 1,000 shares and 53,778 FCPE shares | |
Current directorships and appointments | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
Independent director | In French companies | |
•Member of the Strategy Committee •Member of the Scientific Committee | •None | |
In foreign companies | ||
•Chairman and CEO of Vor Bio * | ||
Past directorships expiring within the last five years | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
•None | In French companies | |
•Chairman of the Board of Directors of ERYTECH Pharma * •Chairman of the Board of Directors of EnnoDC | ||
In foreign companies | ||
•None | ||
Education and professional experience | ||
•M.D. from Faculté Necker-Enfants Malades in Paris and •Former student of Ecole normale supérieure (Ulm) in Paris - Master of Sciences in molecular and cellular pharmacology | ||
Since 2025 | Chairman and CEO of Vor Bio * | |
2019-2024 | CEO of MorphoSys * (acquired by Novartis) | |
2019-2023 | Chairman of the Board of Directors of ERYTECH Pharma * | |
2018 | Chairman and CEO of Syntimmune (acquired by Alexion) | |
2017-2018 | Executive Vice President, International President and Head of Global Therapeutic Operations of Biogen | |
2015-2017 | Member of the Board of Directors of Sarepta Therapeutics | |
2015-2017 | Senior Vice President, Head of North America at Sanofi Genzyme | |
2011-2015 | Chairman and CEO at Sanofi Pasteur MSD | |
2006-2011 | Several positions at Gilead Sciences: •Vice-President and General Manager France •Vice-President, US Sales and marketing, Antiviral Business Unit | |
1997-2006 | General Manager, Denmark / Various US and EU Roles in Marketing, Commercial Operations & Business Development at Abbott | |
1993-1996 | Product Manager at Eli Lilly * | |
* Listed company.
102 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Patrick Kron | |
| Date of birth: September 26, 1953 |
Nationality: French | |
First appointed: May 2014 | |
Last reappointment: May 2022 | |
Term expires: 2026 | |
Business address: Sanofi – 46, avenue de la Grande Armée – 75017 Paris – France | |
Number of shares held: 1,000 | |
Current directorships and appointments | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
Independent director | In French companies | |
•Chairman of the Appointments, Governance and CSR Committee •Member of the Compensation Committee •Member of the Strategy Committee | •Chairman of Imerys * •Chairman of PKC&I SAS: –Permanent representative of PKC&I on the Supervisory Board of Segula Technologies | |
In foreign companies | ||
•Director of Viohalco * (Belgium) •Director of SGS * (Switzerland) | ||
Past directorships expiring within the last five years | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
•None | In French companies | |
•Chairman of Truffle Capital SAS | ||
In foreign companies | ||
•ElvalHalcor * (Greece) | ||
•Director of Holcim * (Switzerland) | ||
Education and professional experience | ||
•Degree from École Polytechnique and École Nationale Supérieure des Mines de Paris | ||
Since 2019 | Chairman of Imerys * | |
Since 2016 | Chairman of PKC&I SAS | |
2016-2024 | Chairman of Truffle Capital SAS | |
2003-2016 | Chief Executive Officer, then Chairman and Chief Executive Officer of Alstom * | |
1998-2002 | Chairman of the Managing Board of Imerys | |
1995-1997 | Manager of the Food and Health Care Packaging Sector at Pechiney, and Chief Operating Officer of American National Can Company in Chicago (United States) | |
1993-1997 | Chairman and Chief Executive Officer of Carbone Lorraine | |
1993 | Member of the Executive Committee of the Pechiney Group | |
1988-1993 | Various senior operational and financial positions within the Pechiney Group | |
1984-1988 | Operational responsibilities in one of the Pechiney Group’s biggest factories in Greece, then manager of the Greek subsidiary of Pechiney | |
1979-1984 | Various positions at the French Ministry of Industry, including as project officer at the Direction régionale de l’Industrie, de la Recherche et de l’Environnement (DRIRE) and in the Ministry’s general directorate | |
* Listed company.
SANOFI FORM 20-F 2025 | 103 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Wolfgang Laux | |
| Date of birth: January 24, 1968 |
Nationality: German and French | |
First appointed: April 2021 | |
Last reappointment: April 2025 | |
Term expires: 2029 | |
Business address: Sanofi – 46, avenue de la Grande Armée – 75017 Paris – France | |
Number of shares held: 3,089 FCPE units and 1,558 performance shares | |
Current directorships and appointments | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
Director representing employees | In French companies | |
•Member of the Compensation Committee | •None | |
In foreign companies | ||
•None | ||
Past directorships expiring within the last five years | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
•None | In French companies | |
•None | ||
In foreign companies | ||
•None | ||
Education and professional experience | ||
•Post-doctoral research fellow at the State University of New York at Stony Brook (1998-2000) and at the University of Montpellier (1996-1997) •Ph.D. in organic chemistry from the University of Frankfurt am Main •Corporate Director’s Certificate from SciencesPo/IFA (Certificat Administrateur de Sociétés) •European Board Diploma by ecoDa | ||
Since 2025 | Product Launch Manager at Sanofi Winthrop Industries, Gentilly (France) | |
Since 2014 | Staff representative on the CFE-CGC ticket | |
2006-2024 | Industrialization Coordinator at Sanofi Chimie and Sanofi Winthrop Industries, Croix-de-Berny and Gentilly (France) | |
2016-2021 | Union delegate | |
2014-2021 | Member of the Works Council, Sanofi Chimie headquarters | |
2016-2019 | Member of the Committee on health, safety and working conditions (CHSCT) | |
2000-2006 | Senior scientist in Process Development at the Frankfurt site of Höchst AG | |
* Listed company.
104 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Barbara Lavernos | |
| Date of birth: April 22, 1968 |
Nationality: French | |
First appointed: April 2021 | |
Last reappointment: April 2025 | |
Term expires: 2029 | |
Business address: Sanofi – 46, avenue de la Grande Armée – 75017 Paris – France | |
Number of shares held: 1,000 | |
Current directorships and appointments | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
Director | In French companies | |
•Member of the Appointments, Governance and CSR Committee | •Vice-Chair of the L'Oréal Climate Emergency Fund | |
•Member of the Strategy Committee | In foreign companies | |
•None | ||
Past directorships expiring within the last five years | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
•None | In French companies | |
•Director of Bpifrance Investment and Bpifrance Participations | ||
In foreign companies | ||
L'Oréal Group*: | ||
•Board member of Lactobio A/S (Denmark) | ||
•Board member of Bak Skincare ApS (Denmark) | ||
Education and professional experience | ||
•Graduate of the HEI chemical engineering school at Lille, France | ||
Since May 2021 | Deputy CEO of L'Oréal * in charge of Research, Innovation and Technology | |
February 2021- May 2021 | President Research, Innovation and Technologies at L’Oréal *– Member of the Executive Committee | |
2018-2021 | Chief Technology and Operations Officer at L’Oréal * – Member of the Executive Committee | |
2014-2018 | Executive Vice-President Operations at L’Oréal * – Member of the Executive Committee | |
2011-2014 | Managing Director of Travel Retail at L'Oréal * | |
2004-2011 | Global Chief Procurement Officer at L'Oréal * | |
* Listed company.
SANOFI FORM 20-F 2025 | 105 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Anne-Françoise Nesmes | |
| Date of birth: May 16, 1971 |
Nationality: British and French | |
First appointed: April 2024 | |
Term expires: 2027 | |
Business address : Sanofi - 46, avenue de la Grande Armée - 75017 Paris - France | |
Number of shares held: 1,000 | |
Current directorships and appointments | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
Independent Director | In French companies | |
•Member of the Audit Committee | •None | |
In foreign companies | ||
•Director of Compass Group PLC (UK) * •Director of Vodafone Group PLC (UK) * | ||
Past directorships expiring within the last five years | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
•None | In French companies | |
•None | ||
In foreign companies | ||
•Chief Financial Officer of Smith & Nephew PLC * | ||
Education and professional experience | ||
•Master's degree from Grenoble Business School and a Master's degree in Business Administration from Henley Business School •Chartered Management Accountant | ||
2020-2024 | Chief Financial Officer of Smith & Nephew PLC | |
2016-2020 | Chief Financial Officer of Merlin Entertainments PLC | |
2013-2016 | Chief Financial Officer of Dechra Pharmaceuticals PLC | |
1997-2013 | Various finance positions, including Senior Vice President of Finance for global vaccines at GlaxoSmithKline PLC * | |
* Listed company.
106 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
John Sundy | |
| Date of birth: October 7, 1961 |
Nationality: American | |
First appointed: April 2024 | |
Term expires: 2027 | |
Business address: Sanofi - 46, avenue de la Grande Armée - 75017 Paris - France | |
Number of shares held: 2,000 American Depositary Receipts, equivalent to 1,000 shares | |
Current directorships and appointments | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
Independent director | In French companies | |
•Member of the Scientific Committee | •None | |
In foreign companies | ||
•Director of Neutrolis Inc •Director of the Childhood Arthritis and Rheumatology Research Alliance (CARRA) | ||
Past directorships expiring within the last five years | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
•None | In French companies | |
•None | ||
In foreign companies | ||
•None | ||
Education and professional experience | ||
•B. S. in biology from Bucknell University •Ph. D in immunology from Hahnemann University •Clinical training in rheumatology and allergy/immunology at Duke | ||
Since 2022 | Chief Medical Officer and Head of Research and Development at Seismic Therapeutic | |
2020-2021 | Chief Medical Officer at Pandion Therapeutics | |
2014-2020 | Several management positions including Senior Vice President at Gilead Sciences | |
2006-2014 | Adjunct Professor of Medicine in the Division of Rheumatology and Immunology at Duke University School of Medicine | |
* Listed company.
SANOFI FORM 20-F 2025 | 107 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Emile Voest | |
| Date of birth: August 20, 1959 |
Nationality: Dutch | |
First appointed: May 2022 | |
Last reappointment: April 2025 | |
Term expires: 2029 | |
Business address: Sanofi – 46, avenue de la Grande Armée – 75017 Paris – France | |
Number of shares held: 1,000 | |
Current directorships and appointments | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
Independent director | In French companies | |
•Member of the Scientific Committee | •None | |
In foreign companies | ||
•Board Member of the Center for Personalized Cancer Treatment •Board Observer of Mosaic Therapeutics •Member of the Supervisory Board of the Hartwig Medical Foundation | ||
Past directorships expiring within the last five years | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
•None | In French companies | |
•None | ||
In foreign companies | ||
•Chairman of the Board of Directors of Cancer Core Europe •Founder and Chair of the Scientific Advisory Board, Clade Therapeutics, Boston MA, USA | ||
Education and professional experience | ||
•Ph.D. in Medicine, cum laude, University of Utrecht | ||
Since 2021 | Co-founder and Strategic Advisor of Mosaic Therapeutics | |
Since 2019 | Senior Group Leader of the Oncode Institute | |
Since 2015 | Founder and Member of Supervisory Board of the Hartwig Medical Foundation | |
Since 2014 | Executive Medical Director (2014-2020) and senior group leader of the Netherlands Cancer Institute | |
Since 2010 | Co-founder and Member of the Executive Board of the Center for Personalized Cancer Treatment (CPCT) | |
Since 1999 | Professor of Internal Medicine/Medical Oncology at University Medical Center Utrecht, The Netherlands | |
2016-2023 | Director of Cancer Core Europe | |
2015-2020 | ESMO (European Society for Medical Oncology) •Chair of the Publications Committee (2016-2020) •Member of the Executive Board (2015-2020) | |
2013-2016 | Co-founder and Non-Executive Medical Director of Hubrecht Organoid Technology | |
* Listed company.
108 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Antoine Yver | |
| Date of birth: January 31, 1958 |
Nationality: American, French, Swiss | |
First appointed: May 2022 | |
Last reappointment: April 2025 | |
Term expires: 2029 | |
Business address: Sanofi – 46, avenue de la Grande Armée – 75017 Paris – France | |
Number of shares held: 1,000 shares | |
Current directorships and appointments | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
Independent director | In French companies | |
•Chairman of the Scientific Committee •Member of the Strategy Committee | •Director of Allspim, Paris | |
In foreign companies | ||
•Director of D3Biologics, Shanghai (PRC) •Chairman of One Carbon Therapeutics, Stockholm (Sweden) •Director of TOAD Oncology, Geneva (Switzerland) | ||
Past directorships expiring within the last five years | ||
WITHIN THE SANOFI GROUP | OUTSIDE THE SANOFI GROUP | |
•None | In French companies | |
•Director of Nexbiome Therapeutics, Clermont-Ferrand (France) | ||
In foreign companies | ||
•Director of Spotlight Therapeutics * | ||
Education and professional experience | ||
•Doctor of Medicine and Pediatrics, University of Paris-Sud 11 | ||
Since 2024 | Pediatrician | |
Current | Advisor to Lilly Asia Ventures, Duality biologics, AptarGroup, Allspim | |
2021-2024 | Chairman of Development of Centessa Pharmaceuticals * | |
2016-2021 | EVP Global Head Oncology R&D at Daiichi Sankyo, Inc. | |
2009-2016 | AstraZeneca* •SVP Head Oncology Global Medicines Development & Lead China GMD (2013-2016) •VP Head Oncology Global Medicines Development & Lead China GMD (2012-2013) •VP Clinical Oncology & New Opportunities (2011-2012) •VP Clinical Oncology & Infection (2009-2011) | |
2006-2009 | Executive Director in Oncology at the Schering-Plough Research Institute | |
2005-2006 | Senior Executive Development Director in Oncology at Johnson & Johnson * | |
1990-2005 | Senior Director Clinical Research at Aventis | |
1981-1990 | Medical doctor at the Assistance Publique des Hôpitaux de Paris | |
* Listed company.
SANOFI FORM 20-F 2025 | 109 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Attendance rates of Board members in 2025
Director | Attendance rate at Board meetings | Attendance rate at Committee meetings |
Frédéric Oudéa | 100% | 96% |
Paul Hudson | 100% | 100% |
Christophe Babule (a) | 92% | 88% |
Clotilde Delbos | 100% | 91% |
Humberto de Sousa (b) | 100% | _ |
Rachel Duan | 100% | 100% |
Carole Ferrand | 100% | 100% |
Lise Kingo | 100% | 100% |
Jean-Paul Kress | 100% | 100% |
Patrick Kron | 100% | 100% |
Wolfgang Laux | 100% | 100% |
Barbara Lavernos (a) | 92% | 93% |
Fabienne Lecorvaisier (c) | 100% | 100% |
Anne-Françoise Nesmes | 100% | 100% |
John Sundy | 100% | 100% |
Yann Tran (c) | 100% | _ |
Emile Voest | 92% | 100% |
Antoine Yver | 100% | 100% |
99% | 98% |
(a)In accordance with the rules on conflicts of interest contained the in the AFEP-MEDEF Code and our Board Charter, Christophe Babule and Barbara
Lavernos, whose appointment to the Board was proposed by L'Oréal, recused themselves from the Board meeting of February 2, 2025 that decided on
the block repurchase of Sanofi shares from L'Oréal. Excluding that meeting, both had a 100% attendance rate.
(b)Humberto de Sousa joined the Board on April 30, 2025.
(c)Fabienne Lecorvaisier and Yann Tran left the Board on April 30, 2025..
Directors who were absent from some meetings provided clear and substantiated explanations for their absence, which related
mainly to personal matters or to unscheduled meetings called at short notice (especially where sudden developments on an
ongoing project necessitated a Board meeting).
Declarations by Board members (including convictions and conflicts of interest)
As of December 31, 2025, no corporate officer has been the subject of any conviction or court order, or been associated with any
bankruptcy or winding-up order. As of this day, there is no potential conflict of interest between any corporate officer and Sanofi.
As of December 31, 2025, the members of our Board of Directors collectively held (directly, or via the employee share ownership
fund associated with the Group savings scheme) 224,077 of our shares, representing 0.018% of our share capital.
Service agreements entered into with Board members
Except as otherwise described below, there are no existing service agreements or arrangements between the Company or any of
its subsidiaries, and any Board member or corporate officer providing for benefits upon termination of employment.
Executive Committee
The Executive Committee is chaired by the Chief Executive Officer.
The only change in the composition of the Executive Committee in 2025 was the departure of Julie Van Ongevalle (Executive
Vice President, Opella), following completion of the divestment of Opella on April 30, 2025. On February 11, 2026, the Board of
Directors relieved Paul Hudson of his duties as Chief Executive Officer effective end-of-day on February 17, 2026, and appointed
Belén Garijo to succeed him after the Shareholders' Meeting of April 29, 2026. With effect from February 18, 2026, Olivier
Charmeil (Executive Vice President, General Medicines), who has been a member of the Executive Committee since 2011, will
serve as Interim Chief Executive Officer.
As of February 17, 2026, the Executive Committee has 12 members, three of whom are women. In accordance with our Board
Charter, the Board of Directors – in liaison with the Compensation Committee and the Appointments, Governance and CSR
Committee, and on a proposal from the Chief Executive Officer – has established a policy on gender representation within
Sanofi's executive bodies. A key objective of this policy is to support the creation of a talent pool of both women and men who
can potentially join the Executive Committee in future.
110 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Paul Hudson
Chief Executive Officer (until end-of-day on February 17, 2026)
Date of birth: October 14, 1967.
Paul Hudson joined Sanofi as Chief Executive Officer on September 1, 2019.
Previously CEO of Novartis Pharmaceuticals (2016-2019), where he was a member of the Executive Committee, Paul has had an
extensive international career in healthcare that spans the US, Japan and Europe.
Prior to Novartis, he worked for AstraZeneca, where he held several increasingly senior positions and most recently carried out
the roles of President, AstraZeneca United States and Executive Vice President, North America.
He began his career in sales and marketing roles at GlaxoSmithKline UK and Sanofi-Synthélabo UK.
Paul holds a degree in economics from Manchester Metropolitan University in the UK and in 2018, his alma mater awarded him an
honorary Doctor of Business Administration for his achievements in the pharmaceutical industry. He also holds a diploma in
marketing from the Chartered Institute of Marketing, also in the UK.
Paul Hudson is a citizen of the United Kingdom.
Houman Ashrafian
Executive Vice President, Head of Research and Development
Date of birth: February 4, 1975.
Houman Ashrafian joined Sanofi on September 11, 2023.
Houman joined Sanofi from SV Health Investors where he was Managing Partner of the global private equity and venture capital
investment platform which has a special focus on biotechnology, healthcare growth equity, and medtech. He has a robust track
record in building high value, successful companies in the healthcare space, that brought transformational medicines from
discovery to market: he co-founded and chaired the biotech companies Alchemab Therapeutics, Dualitas, Enara Bio, Mestag
Therapeutics, Sitryx and Trex Bio. Previously, he was Vice President and head of the Clinical Science Group at UCB with a main
focus on precision medicine strategies and early clinical activities across the R&D portfolio. He also co-founded Cardiac Report, a
cardiac services company, Heart Metabolics, Catamaran Bio, as well as Weatherden, a boutique clinical consultancy.
Houman is an Honorary Consultant Cardiologist at the John Radcliffe Hospital in Oxford, and a Visiting Professor at the University
of Oxford in the UK. He has received numerous prestigious awards and recognitions over the course of his career, including the
Michael Davies Early Career Award from the British Cardiovascular Society and the Schuldham Prize.
Houman has a bachelor’s and master’s degree from the University of Cambridge (UK) and a BM BCh and DPhil from the University
of Oxford (UK).
Houman Ashrafian is a citizen of the United Kingdom.
Natalie Bickford
Executive Vice President, Chief People Officer
Date of birth: July 16, 1970.
Natalie Bickford joined Sanofi on August 1, 2020. She has worked in HR for more than 20 years and brings a wealth of experience
in consumer-facing industries to Sanofi.
Prior to joining Sanofi, Natalie was Group HR Director at Merlin Entertainments, the world’s second largest location-based
entertainment business, where she was responsible for 30,000 employees across Europe, North America, and Asia Pacific. She
also held senior HR positions at Sodexo, AstraZeneca and Kingfisher Plc.
Natalie has a strong track record of transforming organizations, with a strong focus on inclusion and diversity. She was awarded
“HR Diversity Champion of the Year” at the European Diversity Awards in November 2019. Natalie is also Board member of the
Kronos Workforce Institute, a reflection of her deep interest in understanding and shaping the future of work. Natalie is a Board
Advisor to the Coalition for Epidemic Preparedness Innovation (CEPI).
Natalie holds a degree in French and International Politics from the University of Warwick in the UK.
Natalie Bickford is a citizen of the United Kingdom.
SANOFI FORM 20-F 2025 | 111 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Olivier Charmeil
Interim Chief Executive Officer (effective February 18, 2026)
Executive Vice President, General Medicines
Date of birth: February 19, 1963.
From 1989 to 1994, Olivier Charmeil worked in the Mergers & Acquisitions department of Banque de l’Union Européenne. He
joined Sanofi Pharma in 1994 as head of Business Development. Subsequently, he held various positions within Sanofi, including
Chief Financial Officer (Asia) of Sanofi-Synthélabo in 1999 and Attaché to the Chairman, Jean-François Dehecq, in 2000, before
being appointed as Vice President, Development within the Sanofi-Synthélabo International Operations Directorate, where he
was responsible for China and support functions. In 2003, Olivier Charmeil was appointed Chairman and Chief Executive Officer
of Sanofi-Synthélabo France, before taking the position of Senior Vice President, Business Management and Support,
Pharmaceutical Operations. In this role, he piloted the operational integration of Sanofi-Synthélabo and Aventis. He was
appointed Senior Vice President Asia/Pacific, Pharmaceutical Operations in February 2006; Operations Japan reported to him
from January 1, 2008, as did Asia/Pacific and Japan Vaccines from February 2009. On January 1, 2011, Olivier Charmeil was
appointed Executive Vice President Vaccines, and joined our Executive Committee.
In May 2015, Olivier Charmeil and André Syrota were appointed as Co-Leaders of “Medicine of the Future”, an initiative
developed by the French Minister for Economy, Industry and Digital Affairs, the French Minister for Social Affairs, Health and
Women’s Rights and the French Minister for National and Higher Education and Research. They have been tasked with
assembling a group of industrialists and academics, with the objective of imagining how French industry can accelerate the
launch and export of innovative industrial products, with an emphasis on new biotechnologies.
From June 2016 to December 2018, Olivier Charmeil served as Executive Vice President of our General Medicines and Emerging
Markets Global Business Unit.
He took up the position of Executive Vice President China & Emerging Markets in January 2019. In February 2020 he was
appointed to lead the General Medicines GBU, created out of the former Primary Care and China & Emerging Markets GBUs. He
also serves as sponsor for China. Also in 2020, Olivier became a Board Member of the European Federation of Pharmaceutical
Industries and Associations (EFPIA).
Olivier is a graduate of HEC (École des Hautes Études Commerciales) and of the Institut d’Études Politiques in Paris.
Olivier Charmeil is a citizen of France.
Audrey Duval
Executive Vice President, Corporate Affairs
Date of birth: December 6, 1977.
Audrey Duval joined Sanofi in September 2022 as President, Sanofi France.
Audrey began her career in public hospitals in Paris and went on to work as a Researcher at the Pasteur Research Center of Hong
Kong University and then as a Scientific Expert at Salusmed, based in Hong Kong. She later returned to France to join Pfizer,
working in medical affairs in the areas of Endocrinology, Transplant and Rheumatology, and continues to retain that role,
supporting and coordinating Sanofi’s representation to its various external stakeholders in France. Prior to joining Sanofi, Audrey
worked for Novartis, where she served as Business Franchise Head for Ophthalmology and then Country President for the
company’s operations in Ireland.
Audrey holds a Medical Doctorate from the Paris Faculty of Medicine Cochin, and a Bachelor of Science in Medical Biology.
Audrey Duval is a citizen of France.
Brian Foard
Executive Vice President, Specialty Care (until end-of-day on February 28, 2026)
Date of birth: December 20, 1973.
As head of our Specialty Care GBU, Brian oversees an extensive portfolio of medicines in immunology, neuro-inflammation, rare
diseases, and oncology. Brian and his colleagues are responsible for launching treatments in those fields, and for implementing
the strategy to bring Sanofi’s scientific breakthroughs to patients.
Brian joined Sanofi in March 2017 as the Global Head of Dermatology and Respiratory, and held roles of increasing responsibility,
including as Head of Global Immunology for Sanofi and then as US Country Lead and Head of Specialty Care for North America.
He has over 20 years’ experience in the specialist biopharma industry, and began his career with Galderma where he spent more
than 10 years in the US before relocating to Paris to lead global marketing and launch readiness. During his time at Galderma,
Brian also served in roles including General Manager for Australia & New Zealand and Vice President & General Manager of the
global prescription business unit.
Brian received a degree in business from East Carolina University and has completed an executive education course at Wharton.
Brian Foard is a citizen of the United States.
112 | SANOFI FORM 20-F 2025 |
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ITEM 6. Directors, Senior Management and Employees |
Emmanuel Frenehard
Executive Vice President, Chief Digital Officer
Date of birth: October 18, 1972.
Emmanuel Frenehard joined Sanofi in 2020 as Global Head of Digital, and was appointed to the Executive Committee on
August 31, 2023.
Prior to being appointed Chief Digital Officer, he held the positions of Global Head, Digital GBU teams and Digital Products. He
also led the Sanofi Digital Accelerator and a number of digital commerce initiatives.
Before joining Sanofi, Emmanuel spent 20 years leading large global organizations as well as three years in startups. He has built
and launched multiple global digital products in support of existing and new business models. In particular, he managed iflix’s
rollout across Southeast Asia and led the launch of DisneyLife, Disney’s direct-to-consumer digital subscription service, in the UK.
Emmanuel is a graduate of the European Business School (EBS) and holds a Master II in Business, Finance and Audit from the
Institut Supérieur de Gestion (ISG).
Emmanuel Frenehard is a citizen of France.
Brendan O’Callaghan
Executive Vice President, Global Manufacturing & Supply
Date of birth: July 16, 1961.
Brendan O’Callaghan joined Sanofi on January 1, 2015. He joined the Executive Committee on October 1, 2021.
Brendan joined Sanofi in 2015 and was previously Global Head of Biologics and Industrial Affairs Head of the Specialty Care
portfolio. He has played a key role in supporting our transformation to a fully integrated BioPharmaceutical company and
advancing the digital transformation of our manufacturing network.
Prior to Sanofi, Brendan worked at Schering-Plough before moving to Merck & Co. Inc./MSD as Head of Biologics and later Vice
President of its Europe, Middle East and Africa Operations.
Brendan graduated in chemical engineering from the University College of Dublin, where he currently serves as an honorary
adjunct Professor of Chemical and Biochemical Engineering.
Brendan O’Callaghan is a citizen of Ireland.
Roy Papatheodorou
Executive Vice President, General Counsel
Date of birth: May 15, 1978.
Roy Papatheodorou joined Sanofi on February 1, 2022.
Roy Papatheodorou leads the Legal, Ethics and Business Integrity and Global Security (LEBI & GS) team. The LEBI & GS team is
composed of lawyers, patent attorneys, compliance officers and security professionals covering Sanofi’s operations around the
world. Its team members play an essential role in protecting the interests of the company and of its patients, customers,
shareholders, and employees while delivering on Sanofi’s strategy and contributing to its long-term ambition to transform the
practice of medicine.
Before joining Sanofi, Roy served as General Counsel of Novartis Pharmaceuticals from 2017. Prior to that, he headed up Legal
Transactions at Novartis covering mergers & acquisitions, business development & licensing, antitrust, corporate & finance law,
and venture funds.
From 2011 to 2013, he was Group General Counsel and Secretary to the Board of Directors at Actavis, a leading global generic
pharmaceuticals company. Prior to this, Roy spent several years at Linklaters in London, Moscow and Sao Paulo, advising mainly
on corporate law, international mergers & acquisitions, private equity, and restructurings.
Roy completed a Legal Practice Course from BPP School of Law in London and holds an LLB in Law from King’s College London.
He is a qualified solicitor in England & Wales.
Roy Papatheodorou is a citizen of Cyprus and Italy.
Madeleine Roach
Executive Vice President, Business Operations
Date of birth: May 23, 1984.
Madeleine Roach joined Sanofi in 2022 as Head of Internal Audit and Risk Management, before being appointed to the Executive
Committee on October 1, 2023.
Prior to joining Sanofi, Madeleine served at AstraZeneca as Head of Group Finance Services, Asia-Pacific and Head of Global
Business Services Site Lead in Malaysia, delivering a wide range of business services to stakeholders and further expanding the
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ITEM 6. Directors, Senior Management and Employees |
site with the addition of value-added services and digitalization capabilities, whilst attracting top talent through strong employer
branding.
Madeleine also held positions of growing responsibility in Finance and Global Business Services at AstraZeneca, after starting her
career at PricewaterhouseCoopers and KPMG in Assurance and Advisory services, in Germany and the UK.
Madeleine holds a BA (Hons) in Economics and Politics from the School of Oriental and African Studies, University of London.
Madeleine Roach is a citizen of Germany.
François Roger
Executive Vice President, Chief Financial Officer
Date of birth: May 14, 1962.
François Roger has served as Chief Financial Officer of Sanofi since April 2024, leading a team that manages financial risk and
capital allocation to create value and growth for Sanofi.
François joined Sanofi from Nestlé where he was CFO for nearly nine years. Before Nestlé, he served from 2013 to 2015 as CFO of
Takeda Pharmaceuticals, based in Japan. He spent the first 14 years of his career working in the pharmaceutical industry, first at
Roussel, Hoechst and later Aventis, serving in various countries. He worked at Danone from 2000 to 2008 in various finance roles
and was CFO of Millicom, a NASDAQ listed, global mobile phone operator from 2008 to 2013. He has lived and worked in Europe,
the United States, Asia, Africa and Latin America.
François holds an MBA from Ohio State University in the US and a Major in Accounting from Audencia Business School in France.
François Roger is a citizen of France.
Thomas Triomphe
Executive Vice President, Vaccines
Date of birth: August 6, 1974.
Thomas Triomphe joined Vaccines in 2004 and has since advanced within the company in several roles of increasing
responsibility in sales and marketing at country, regional and global levels. From 2015 to 2018, he was Head of the Asia-Pacific
Region, based in Singapore. Before that, he served as Head of Vaccines Japan from 2012 to 2015. In 2010, he became Associate
Vice President, Head of the Influenza-Pneumo Franchise after three years as Director for the same franchise, based in the United
States. Earlier in his career, Thomas worked in banking and strategic consulting.
Thomas served as Vice President and Head of Franchise & Product Strategy for Vaccines from January 2018, in which position he
implemented the strategy for our vaccine franchises, in close collaboration with Manufacturing & Supply and R&D.
He was appointed to his current position on June 15, 2020.
Thomas earned his MSc in industrial engineering from École des Ponts ParisTech and the IFP School, and he also holds an MBA
from INSEAD.
Thomas Triomphe is a citizen of France.
On February 17, 2026, Sanofi announced the nomination of Manuela Buxo as Executive Vice President, Specialty Care, effective
March 1, 2026. Manuela Buxo will succeed Brian Foard, who has decided to leave the company as of February 28, 2026, having
accepted an external leadership opportunity.
Manuela Buxo
Executive Vice President, Specialty Care (effective March 1, 2026)
Date of birth: November 2, 1975
Manuela Buxo is a global healthcare executive with over 25 years of experience driving growth, transformation and innovation
across Specialty Care and Consumer Health. Across an international career spanning 6 countries, she has held leadership roles of
increasing responsibility at Bayer and Sanofi at country, regional, and global levels.
Since 2023, she has served as Global Head of Immunology Alliance, overseeing Dupixent and Kevzara. She joined Sanofi in 2014
as Vice President of Global Categories & Innovation for the Consumer Health division. In 2017, she was appointed Senior Vice
President, Global Strategic Marketing, before taking on responsibility for Region Europe in the Specialty Care Global Business
Unit in 2020, which included therapeutic areas such as immunology, neurology, oncology, rare diseases, and rare blood disorders.
She graduated from HHL Leipzig Graduate School of Management and holds an undergraduate degree from Friedrich Schiller
University Jena.
Manuela Buxo is a citizen of Germany.
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ITEM 6. Directors, Senior Management and Employees |
B. Compensation
Compensation and other arrangements for corporate officers
Process for determining the compensation policy for corporate officers
The compensation policy for corporate officers is established by the Board of Directors, acting on the recommendation of the
Compensation Committee. The Board of Directors applies the AFEP-MEDEF Code when determining the compensation and
benefits awarded to our executive and non-executive corporate officers.
All members of the Compensation Committee are independent, and were chosen for their technical competencies and their
knowledge of current standards, emerging trends and Sanofi’s practices.
To fulfill their remit, the Committee regularly invites Sanofi’s Chief People Officer and Head of Reward and Performance to attend
their meetings. Committee members also work with the Chairman and the Secretary of the Board, who have contacts with our
principal institutional shareholders ahead of the Annual General Meeting.
In addition, the Chair or a member of the Committee:
•discusses the financial, accounting and tax impacts of the proposed compensation policy with the Chair of the Audit
Committee;
•plays an active role at meetings of the Appointments, Governance and CSR Committee and the Strategy Committee (to both
of which he/she belongs), thereby gaining assurance that the proposed performance criteria are consistent and appropriate in
light of Sanofi’s strategic ambitions.
The compensation policy is not subject to annual review, although some arrangements for implementing the policy – such as the
performance criteria applicable to the Chief Executive Officer’s annual variable compensation, for example – are defined by the
Board of Directors on an annual basis.
After consulting the Compensation Committee and as the case may be the other Board Committees, the Board of Directors may,
under the second paragraph of item III of Article L. 22-10-8 of the French Commercial Code, temporarily derogate from the
approved compensation policy for the Chief Executive Officer in exceptional circumstances and to the extent that the changes
are aligned with the corporate interest and necessary to safeguard the continuity or viability of Sanofi. Derogations from the
approved policy are possible in respect of the performance conditions applied to the Chief Executive Officer’s compensation,
and may result in either an increase or a decrease in compensation. Such derogations are possible in the event of a change in the
structure of the Sanofi group or major events affecting the markets. Such derogations may only be temporary and must be
properly substantiated.
Compensation policy for corporate officers
This section describes the compensation policy for corporate officers of Sanofi, as established pursuant to Article L. 22-10-8 of
the French Commercial Code. The compensation describes all the components of compensation awarded to corporate officers
of Sanofi as consideration for holding office, and explains the process by which it is determined, allocated, reviewed and
implemented.
Our compensation policy for corporate officers has three distinct elements: (i) the compensation policy for directors; (ii) the
compensation policy for the Chairman of the Board; and (iii) the compensation policy for the Chief Executive Officer.
Each of those policies is submitted for approval by our shareholders at the Annual General Meeting, in accordance with
Article L. 22-10-8 II of the French Commercial Code. The compensation policy approved in any given year applies to any person holding
a corporate office in that year. When a corporate officer is appointed between two Annual General Meetings, their compensation is
defined by applying the terms of the compensation policy approved by the most recent Annual General Meeting.
The compensation policy for Paul Hudson (Chief Executive Officer until end-of-day on February 17, 2026) for the period from
January 1, 2026 through February 17, 2026, is described below under "— Compensation policy for Paul Hudson". The
compensation policies for Olivier Charmeil (appointed as Interim Chief Executive Officer as of February 18, 2026) and Belén Garijo
(who will assume office as Chief Executive Officer after the Annual General Meeting of April 29, 2026) will be determined by the
Board of Directors at a later date, and included in a Report on Form 6-K that will also be published on the Sanofi corporate
website.
General principles and objectives
Our compensation policy is based on the following general principles:
•the policy must be simple;
•the policy must prioritize long-term performance;
•the level of compensation must be competitive, so that we can attract and retain talent; and
•there must be a fair balance between the corporate interest, the challenges of delivering on our strategy, and the
expectations of our stakeholders.
The Compensation Committee must ensure that trends in the compensation of corporate officers over the medium term are not
uncorrelated with trends in the compensation of all our employees. In terms of annual variable compensation and equity-based
compensation, the Compensation Committee aims to achieve convergence between the performance criteria applied to our
Senior Leaders and those applied to the Chief Executive Officer.
(1)Amounts paid to directors who held office for the entire year.
(2)Amgen Inc., AstraZeneca plc, Bayer AG, Bristol-Myers-Squibb Inc., Eli Lilly and Company Inc., GlaxoSmithKline plc, Johnson & Johnson Inc., Merck & Co.
Inc., Novartis AG, Novo Nordisk A/S, Pfizer Inc., and Roche Holding AG.
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ITEM 6. Directors, Senior Management and Employees |
Our equity-based compensation policy, which aims to align employee and shareholder interests and reinforce loyalty to Sanofi, is
a critical tool for our worldwide attractiveness as an employer.
Grantees of equity-based compensation plans (including our Chief Executive Officer) can only be awarded performance shares.
Awarding performance shares reduces the dilutive effect of equity-based compensation plans while maintaining the same level
of motivation for grantees.
Acting on the recommendation of the Compensation Committee, the Board of Directors determines the performance conditions
attached to equity-based compensation for all grantees at Sanofi and its subsidiaries worldwide, thereby furthering the
attainment of our objectives.
The Board of Directors makes any grant of performance shares contingent on multiple, exacting multi-year performance criteria
in order to ensure that our equity-based compensation plans incentivize overall performance. Failure to achieve those criteria
over the entire performance measurement period results in a reduction or loss of the initial grant.
In order to align equity-based compensation with our long-term performance, performance is measured over three financial
years (the “vesting period”). Awards of performance shares are also contingent on continued employment in the Sanofi group
during the vesting period, followed by stringent lock-up obligations in the case of the Chief Executive Officer (see below).
The terms of prior awards cannot be reset subsequently, for instance with less exacting performance conditions.
Compensation policy for directors
Directors hold office for a four-year term, as specified in our Articles of Association (except in the event of staggered terms). They
may be removed from office by a shareholders’ meeting, at any time and without restriction.
The maximum annual amount of overall compensation allocated to the directors was set at €2,500,000 by the Annual General
Meeting of May 25, 2023. The average compensation per director(1) was approximately €164,520 in 2024, and approximately
€178,205 in 2025. Almost all of that maximum annual amount was paid out in 2024, while in 2025 the maximum annual amount
was exceeded such that directors' entitlement to compensation had to be apportioned on a pro rata basis, and they received
4.14% less compensation than they should have done.
At the end of 2025, the Compensation Committee decided to review the allocation mechanism and to recalibrate the maximum
annual amount, to ensure that it was fit for purpose.
The Committee conducted a benchmarking exercise involving (i) a panel of the twelve leading global pharmaceutical
companies(2), which showed a significant gap in compensation, and (ii) companies in the French CAC 40 index. Those two peer
groups were chosen by the Committee so as to obtain a rounded and relevant overview of market practices. The benchmarking
exercise, conducted on the basis of 2024 data, showed that:
•The maximum overall annual amount allocated to Sanofi directors was below the average for the twelve leading global
pharmaceutical companies (€3,585,827), as was the average compensation per director (€211,931 for the panel, compared to
€161,770 per Sanofi director), bearing in mind also that the average per director varied between regions:
–(i) €322,591 for companies based in the US, (ii) €379,830 for companies based in Switzerland, and (iii) €202,106 for
companies based in the EU and the UK.
•The maximum overall annual amount allocated to Sanofi directors was the third highest in the CAC 40 (average: €1,476,528),
even though Sanofi averages more Board members (16) than the CAC 40 (12), and the average annual compensation per
director was the fifth highest in the CAC 40 (average: €112,770, versus €164,520 for a Sanofi director).
The Compensation Committee also assessed specific issues around attractiveness, and the retention of people with the right
profile for Board membership in the pharmaceutical industry:
•The need to maintain compensation at a competitive level, given that Sanofi has to be able to attract and retain Board
members with the unusual skillsets and competencies required for a proper understanding of the pharmaceutical industry.
•The fact that directors' compensation at Sanofi has not been reviewed for several years. The fixed portion of €30,000 has not
changed since 2016, and the amount of compensation per meeting (€5,500 for a director resident in France) since 2019.
Finally, the Compensation Committee considered the changing workload of directors, and the increasing complexity of the work
of the Board and its committees:
•The need to reflect the increased workload of the Board and its committees, which has become apparent in recent years and
is likely to remain high in future. To facilitate dynamic decision-making in a fast-moving business context (especially in terms
of reviewing divestments and acquisitions, and monitoring progress on the R&D pipeline), Board practices have evolved
towards more frequent meetings (more than 10 Board meetings a year since 2022). In addition, a steady rise in the number of
committee meetings was seen in 2025, especially for the Scientific Committee (11 meetings in 2025, compared with 6 in 2024).
•The increasingly complex geopolitical situation, which has triggered major transformations in the pharmaceutical industry.
(3)AstraZeneca plc, Bayer AG, GlaxoSmithKline plc, Novo Nordisk A/S.
(4)Average total overall allocation of €3,585,827, and average compensation per director of €302,300.
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ITEM 6. Directors, Senior Management and Employees |
Based on the findings above, the Board of Directors - on a recommendation from the Compensation Committee - has decided to
change the allocation mechanism for directors' compensation with effect from 2026 by (i) increasing the fixed portion from
€30,000 to €37,500 for all directors and (ii) raising the amount of compensation per meeting by €1,000 per Board meeting, by
€500 per committee meeting, and by €1,000 per meeting for committee chairs.
To allow for that change in the allocation mechanism, the Board of Directors will ask the Annual General Meeting of April 29, 2026
to approve an increase in the maximum annual amount of overall compensation allocated to the directors with effect from the
2026 financial year, from the current €2,500,000 to €3,200,000. That would take the maximum annual overall amount to the
highest ranking in the CAC 40, and raise both the maximum annual amount and the average compensation per director (which
would be €213,000) to a level comparable with the averages computed for global pharmaceutical companies headquartered in
Europe (EU and UK, but excluding Switzerland which has specific characteristics)(3), while nonetheless remaining below the
average level of directors' compensation for the twelve leading global pharmaceutical companies(4).
The new allocation mechanism would still be in compliance with the AFEP-MEDEF Code, which requires directors' compensation
to be allocated predominantly on a variable basis.
The table below shows how the variable amount payable to directors for attendance at Board and committee meetings will be
determined with effect from 2026, subject to approval of the compensation policy by the next Annual General Meeting of Sanofi
shareholders:
Compensation per meeting | ||||
Directors resident in France | Directors resident outside France but within Europe | Directors resident outside Europe | Chair | |
Board of Directors | €6,500 | €9,250 | €12,000 | N/A |
Audit Committee | €8,750 | €11,500 | €14,250 | €14,750 |
Compensation Committee | €6,000 | €8,750 | €11,500 | €12,000 |
Appointments, Governance and CSR Committee | €6,000 | €8,750 | €11,500 | €12,000 |
Strategy Committee | €6,000 | €8,750 | €11,500 | N/A |
Scientific Committee | €6,000 | €8,750 | €11,500 | €12,000 |
The distinction between directors resident within or outside Europe is intended to reflect the significantly longer travel time
required to attend Board meetings in person.
Directors who take part via videoconference receive compensation equivalent to that paid to a director resident in France
attending in person, except for committee chairs who continue to receive the usual compensation in respect of the committee
they chair.
As an exception, in certain cases two meetings held on the same day give entitlement only to a single payment:
•if on the day of a Shareholders’ General Meeting, the Board of Directors meets both before and after the meeting, only one
payment is made for the two Board meetings; and
•if on the same day a director participates in a meeting of the Compensation Committee and a meeting of the Appointments,
Governance and CSR Committee, only the higher of the two payments is made to cover both meetings.
Since 2025, attendance at a meeting that does not last for more than 60 minutes does not automatically give entitlement to
compensation; Board members must have accumulated at least two and a half hours of attendance at meetings before they
receive compensation.
Directors do not receive any exceptional compensation or equity-based compensation and have no entitlement to a top-up
pension plan.
Neither the Chairman of the Board nor the Chief Executive Officer receives any compensation for serving as a director.
Compensation policy for the Chairman of the Board of Directors
The term of office of the Chairman of the Board is the same as that of the other directors (four years), and the Chairman’s term is
aligned with his term of office as a director. He may be removed from office at any time by the Board of Directors.
The compensation policy for the Chairman of the Board of Directors is discussed by the Compensation Committee, which then
makes a recommendation to the Board of Directors. The Chairman of the Board is not a member of the Committee, and does not
attend meetings where his compensation is discussed.
The compensation of the Chairman of the Board of Directors (where the office of Chairman is separate from that of Chief
Executive Officer, as is currently the case) consists solely of fixed compensation and benefits in kind and excludes any variable or
exceptional compensation, any awards of stock options or performance shares, and any compensation for serving as a director.
The annual fixed compensation awarded to the Chairman of the Board of Directors is €880,000 gross. That amount was set at
the Board meeting of February 22, 2023, and has not changed since May 25, 2023 (the date on which the current Chairman took
office).
(5)Studies carried out on the basis of figures disclosed by the companies, supplemented by analyses conducted by Pay Governance and Boracay.
Sanofi's ranking within the panel is based on an ex ante analysis of target compensation and ex ante theoretical maximum compensation, incorporating
(i) base salary applicable for the 2025 financial year as approved by a shareholder meeting, or (failing that) the most recently published base salary;
(ii) annual bonus (target and maximum); and (iii) long-term incentive plan awards (target and maximum theoretical levels), as specified in compensation
policies.
For 2025 long-term incentive plans, in cases where no IFRS fair value has been disclosed to date for 2025 plan awards, the valuation used relies on an ex
ante assumption based on the target level of awards specified by the 2025 ex ante compensation policy or (failing that) using a benchmark methodology
based on the valuation of the plan awarded in respect of the previous financial year.
The analysis relative to the CAC 40 panel relies on a valuation of long-term incentive plan awards expressed in IFRS fair value terms at the date of grant,
in accordance with market practices applicable to French companies.
The analysis relative to the global panel relies on a valuation of long-term incentive plan awards expressed at (i) face value in the case of awards of
performance shares and Restricted Stock Units (target number of shares, multiplied by the closing quoted share price on the date of grant) and (ii) fair
value for accounting purposes in the case of stock options, as disclosed by the companies in accordance with US market practices.
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ITEM 6. Directors, Senior Management and Employees |
This amount takes account of the specific remit of the Chairman of the Board of Directors as described in the Sanofi Board
Charter, and of his membership of three Board Committees (the Strategy Committee, which he chairs; the Appointments,
Governance and CSR Committee; and the Scientific Committee).
The compensation of the Chairman of the Board of Directors is not subject to annual review.
Where the office of Chairman is separate from that of Chief Executive Officer, the Chairman of the Board is not entitled to the
Sanofi top-up defined-contribution pension plan.
Nor is he entitled to a termination benefit or a non-compete indemnity.
Compensation policy for Paul Hudson
General principles
Paul Hudson, our Chief Executive until end-of-day February 17, 2026, did not have a fixed term of office and could be removed
from office on legitimate grounds at any time by the Board of Directors.
The compensation policy for the Chief Executive Officer is established by the Board of Directors, acting on the recommendation
of the Compensation Committee. The compensation structure is not subject to annual review and is applicable for as long as it
remains unchanged. The arrangements for implementing the policy may vary from year to year; a table showing the changes
made to those arrangements in 2026 and 2025 is provided at the end of the present section. The components of the Chief
Executive Officer's compensation as determined by the Board of Directors for 2026 are described below, in the section entitled
"—Compensation and benefits of all kinds awardable to corporate officers in respect of 2026" below. That section forms an
integral part of the compensation policy of the Chief Executive Officer for 2026 that will be submitted for approval by the Annual
General Meeting.
The Chief Executive Officer's overall compensation is determined with reference to (i) experience and key stakeholder
expectations and (ii) practices adopted by (a) a panel of CAC 40 companies and (b) a panel of pharmaceutical companies with
which Sanofi is in competition. Because Sanofi operates in a particularly competitive international environment and has broad
geographical reach (with over three-quarters of its net sales generated in the US and non-European countries), a panel is used
comprising the Chief Executive Officer compensation of 12 leading global pharmaceutical companies with comparable levels of
net sales to Sanofi, but with no limitation as to geography. That panel has remained unchanged since 2020.
This consistency with market practice is fundamental in order to attract and retain the talents necessary to our success, but does
not imply that Sanofi should adopt in every respect practices that are in some cases widely divergent, especially as regards the
level of long term compensation.
Market practice based on a panel of 14 CAC 40 companies
Local practices are reviewed by reference to a panel of 14 CAC 40 companies with a comparable profile to Sanofi in terms of
market capitalization, net sales, market presence, return on capital employed, etc; the panel was selected with assistance from an
external consultant(5). This study showed that Sanofi ranks seventh among the panel in terms of market capitalization, and ninth in
terms of net sales.
Air Liquide | Airbus | AXA | Danone | Dassault Systèmes |
EssilorLuxottica | Kering | L'Oréal | LVMH | Saint-Gobain |
Schneider Electric | Stellantis | TotalEnergies | Vinci |
Based on an ex ante analysis of this panel for the 2025 financial year, the fixed compensation of our Chief Executive Officer ranks
equal fourth within the panel, and his ex ante target short-term compensation (fixed plus target variable) ranks fifth. His target ex
ante equity-based compensation ranks fourth within the panel, largely because our Compensation Committee takes some
account of practices adopted by our pharmaceutical industry competitors (see below). His ex ante target overall compensation
(fixed, variable and equity-based) also ranks fourth within the panel. Finally, his ex ante theoretical maximum overall
compensation, due under the compensation policy in the event of outperformance of the maximum attainment levels, ranks fifth
within the panel.
(6)Some companies do not disclose target equity-based compensation.
(7)Actual total compensation represents the sum total of (i) fixed compensation actually paid, (ii) variable compensation paid, (iii) gains arising from exercise
of stock options, and (iv) the value of shares acquired at the end of the vesting period. The analysis covers the years 2022, 2023 and 2024. For US
companies, the value of acquired shares is derived from Stock Vested disclosures in annual report filings; for non-US companies, it is derived from actual
compensation or final allocation disclosures. Roche Holding AG was excluded from the analysis because it does not disclose this information.
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ITEM 6. Directors, Senior Management and Employees |
Market practice based on a panel of 12 global pharmaceutical companies
Amgen Inc. | AstraZeneca plc | Bayer AG | Bristol-Myers-Squibb Inc. | Eli Lilly and Company Inc. |
GlaxoSmithKline plc | Johnson & Johnson Inc. | Merck & Co. Inc. | Novartis AG | Novo Nordisk A/S |
Pfizer Inc. | Roche Holding AG |
This study showed that Sanofi ranks tenth among the panel in terms of market capitalization, and eighth in terms of net sales.
Based on an ex ante analysis of this panel, for 2025 the fixed compensation of our Chief Executive Officer ranks eighth within the
panel, as does his target short-term compensation (fixed+variable). His theoretical maximum equity-based compensation ranks
eleventh(6). His ex ante theoretical maximum overall compensation (fixed, variable and equity-based) ranks twelfth within the
panel, and his ex ante theoretical target overall compensation ranks eleventh.
In addition, an analysis of actual total compensation for the 2022-2024 period places our Chief Executive Officer at the second
lowest ranking within the panel, and hence in the lowest quartile of the sample(7).
Approval of the compensation policy of the Chief Executive Officer for 2025 by the Annual General Meeting of
April 30, 2025
Following a review of the structure of the Chief Executive Officer's compensation package, the Board meeting of
February 12, 2025, acting on a recommendation from the Compensation Committee, decided to (i) raise the Chief Executive
Officer's annual fixed compensation to €1,600,000, and (ii) increase the quantum of his allocation of equity-based compensation
for 2025 subject to the ceiling set by the compensation policy. In addition, to reinforce (i) alignment between the respective
interests of Sanofi, the Chief Executive Officer and our shareholders and (ii) the stringent nature of the performance conditions,
the weighting of the Total Shareholder Return (TSR) criterion for the Chief Executive Officer's performance share plan was raised
from 20% to 30% with effect from 2025. The other components of the Chief Executive Officer's compensation were unchanged.
The fifteenth resolution (referring to approval by the April 30, 2025 Annual General Meeting of the compensation policy for the
Chief Executive Officer) was approved with 75.36% of the votes cast.
The Compensation Committee meeting of October 21, 2025 reviewed the results of the votes cast, along with comments made
both before and after the Annual General Meeting, including discussions between the Chairman of the Board and a shareholder
panel representing approximately 30% of Sanofi's share capital. This enabled the Chairman of the Board to gauge not only the
sensitivity but also the divergent opinions among the shareholder base around the issue of increases in executive compensation.
The main reservations expressed were:
•the theoretical overall quantum of post-increase compensation: some investors adopt an approach narrowly aligned on the
specific context around executive pay in France, while others took the view that the quantum of compensation is an incentive
that drives success, especially given the specific nature of the pharma industry and the profile of Sanofi's principal
competitors;
•the timing of the increase on the part of our Board of Directors, three years after the previous increase: some investors favor
more regular reviews of fixed compensation, while others make the case for a longer interval between reviews;
•the Compensation Committee's decision to benchmark using target compensation: some investors saw this as a robust
approach given the equity-based compensation structure adopted by Sanofi (which does not allow for over-allocation at the
end of the vesting period), while others objected to this methodology and the associated level of transparency;
•the structure of equity-based compensation plans that allow for offset between criteria; and
•lack of transparency around performance objectives for confidentiality reasons, especially concerning (i) the thresholds set for
attaining of the objectives for annual variable compensation and equity-based compensation and (ii) the CSR objectives,
which are not sufficiently detailed.
Those concerns highlight the difficulties our Board of Directors faces in reconciling the expectations of all our investors, who are
constrained by strict - and sometimes contradictory - voting policies.
After taking into account the views expressed by shareholders, the Board meeting of October 23, 2025, on a recommendation
from the Compensation Committee, decided in the interests of transparency to implement the following improvements:
•the narrative in the report on compensation regarding the use of benchmarks has been reviewed, and information is provided
to a greater degree of granularity, thereby expectations of shareholders and proxy advisers by making it clearer and easier to
understand;
•the transparency of our performance objectives (especially our CSR objectives) has been enhanced, again in line with the
expectations of shareholders and proxy advisers; and
•in terms of the structure of equity-based compensation plans, the Board takes the view that the current compensation
arrangements can be retained given that (unlike for most of the companies in the pharma sector peer panel) the number of
shares delivered at the end of the vesting period cannot exceed the number of shares awarded (100% cap), thereby striking a
balance between the need to compensate our Chief Executive Officer commensurately with his actual performance on the
one hand, and avoiding excess vesting levels decoupled from the interests of shareholders.
SANOFI FORM 20-F 2025 | 119 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
The Chairman of the Board of Directors and senior members of our team have in recent years engaged in constant, constructive
dialogue with shareholders; this approach will be maintained, to ensure we listen to shareholders' views on compensation policy.
On taking up office
When the Chief Executive Officer is an outside appointment, the Board of Directors may decide, acting on a recommendation
from the Compensation Committee, to compensate the appointee for some or all of the benefits he may have forfeited on
leaving his previous employer. In such a case, the terms on which the Chief Executive Officer is hired aim to replicate the diversity
of what was forfeited, with a comparable level of risk (variable portion, medium-term equity-based or cash compensation).
During the term of office
Compensation structure
Our policy aims at achieving and maintaining a balance in the compensation structure between fixed compensation, benefits in
kind, short-term variable cash compensation, and medium-term variable equity-based compensation.
The compensation policy for the Chief Executive Officer is designed to motivate and reward performance by ensuring that a
significant portion of compensation is contingent on the attainment of financial, operational and extra-financial criteria that
reflect Sanofi’s objectives, and are aligned with the corporate interest and with the creation of shareholder value. Variable cash
compensation and equity-based compensation are the two principal levers for action, and are intended to align the interests of
the Chief Executive Officer with those of our shareholders and stakeholders.
During the meeting that follows the Board meeting held to close off the financial statements for the previous year, the
Compensation Committee examines the levels of attainment of variable compensation for that year. In advance of that meeting,
the Chief Executive Officer presents the Committee with a report containing narrative and quantitative information necessary to
measure attainment of the objectives. The members of the Compensation Committee then discuss the information provided and
report to the Board on those discussions, giving an evaluation of the Chief Executive Officer’s performance against each of the
criteria (determining the level of attainment for quantitative objectives, and evaluating the level of attainment for qualitative
objectives compared to the objectives set at the beginning of the year).
Annual fixed compensation
The annual fixed compensation of the Chief Executive Officer has been set at €1,600,000 gross with effect from 2025.
The amount of fixed compensation is not subject to annual review. It may however be changed, provided that such changes are
not material:
•on the appointment of a new Chief Executive Officer, to reflect the new appointee’s competencies and/or then current
market practice; and
•in exceptional circumstances, to take account of changes in (i) the role or responsibilities of the Chief Executive Officer, for
example in terms of market conditions or the size of the Sanofi group or (ii) the performance level of Sanofi over a given period.
Annual variable compensation
Annual variable compensation is in a range between 0% and 250% of fixed compensation, with a target of 150%. It is subject to
a range of varied and exacting performance criteria, both quantitative and qualitative. The criteria are reviewed annually in light
of the strategic objectives determined by Sanofi. The Board of Directors sets the criteria for each year at the start of that year,
acting on a recommendation from the Compensation Committee.
For 2026, the criteria determined at the Board meeting of February 11, 2026 are:
•60% based on financial indicators published by Sanofi: sales growth, free cash flow (FCF) and business earnings per share
(business EPS), each accounting for 20%; and
•40% based on specific individual objectives: Portfolio & Assets (7.5%); Digital Transformation and Artificial Intelligence (7.5%);
R&D Pipeline (15%); and Corporate Social Responsibility (10%). The individual objectives set for variable remuneration for 2026
are described in “— Compensation and benefits of all kinds awardable to corporate officers in respect of 2026” below.
Although for each of those financial criteria the Board of Directors (acting on a proposal from the Compensation Committee) has
set specific objectives, those objectives cannot be disclosed for confidentiality reasons. Nevertheless, to align on shareholder
expectations Sanofi provides ex-post disclosures for each financial criterion, showing key thresholds within the range of
outcomes that enable attainment levels for the past financial year to be calculated (see “— Compensation and benefits of all
kinds paid during 2025 or awarded in respect of 2025 to Paul Hudson” below).
The percentage of variable compensation linked to the attainment of quantitative criteria may be scaled down regardless of
actual performance, in order to give greater weight to the attainment of qualitative criteria. This flexibility can only operate to
reduce the amount of variable compensation, and cannot compensate for underperformance on quantitative criteria.
Payment of annual variable compensation in a given year in respect of the previous year is contingent on a favorable shareholder
vote at the Annual General Meeting.
120 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Equity-based compensation
The Chief Executive Officer’s equity-based compensation can only be awarded in the form of performance shares, and his
allocation is determined in terms of the number of shares rather than by value. It cannot be reviewed annually, and may represent
up to 250% of his target short-term compensation (fixed plus variable).
The Chief Executive Officer’s equity-based compensation is contingent upon attainment of exacting performance conditions, all
of them quantitative, measured over a three-year-period. Such awards are contingent both upon internal criteria (financial and
extra-financial) and external criteria.
As indicated in our currently applicable performance share plans, our Board of Directors reserves the right to adjust, both
upwards and downwards and within the limits of policy, the performance conditions in exceptional circumstances justifying such
an adjustment (if the Compensation Committee so advises), and specifically in the event of (i) a change in the structure of the
Sanofi group, (ii) a change in accounting policy, or (iii) any other circumstances that would justify such an adjustment, in the
opinion of our Board of Directors. The purpose of such an adjustment would be to ensure that the results of applying
performance conditions reflect the above-mentioned changes. Any such adjustments would be justified and disclosed ex-post in
our annual report on Form 20-F.
Acting on a proposal from the Compensation Committee, the Board of Directors has sought to maintain common criteria for
annual variable compensation and equity-based compensation, in order to ensure that short-term performance does not come
at the expense of long-term performance.
The valuation of performance shares is calculated at the date of grant, weighted between (i) fair value determined using the
Monte Carlo model and (ii) the market price of Sanofi shares at the date of grant, adjusted for dividends expected during the
vesting period.
Each award to our Chief Executive Officer takes into account previous awards and his overall compensation. In any event, the
maximum number of shares to be delivered may not be more than the number of performance shares initially awarded.
Given the decision by our Board of Directors to relieve Paul Hudson of his duties as Chief Executive Officer effective end-of day
on February 17, 2026, it has been decided that he would not been awarded any performance shares in respect of 2026.
Share ownership and lock-up obligation of the Chief Executive Officer
The Chief Executive Officer is bound by the same obligations regarding share ownership specified in our Articles of Association
and Board Charter as our other corporate officers.
In addition, the Chief Executive Officer is bound by an obligation to retain, until he ceases to hold office, a quantity of Sanofi
shares corresponding to 50% of the capital gain (net of taxes and social contributions) arising on the vesting of his shares,
calculated as of the date on which they vest. Those shares must be held in registered form until he ceases to hold office.
In compliance with the AFEP-MEDEF Code and our Board Charter, the Chief Executive Officer must undertake to refrain from
entering into speculative or hedging transactions.
Multi-year variable compensation
The Chief Executive Officer does not receive multi-year variable compensation.
Compensation for serving as a director
Executive officers of Sanofi do not receive any compensation for serving as directors. Consequently, the Chief Executive Officer
does not receive compensation in his capacity as a director or as a member of the Strategy Committee.
Exceptional compensation
No exceptional compensation can be awarded to the Chief Executive Officer.
On leaving office
The Chief Executive Officer is entitled to a top-up defined-contribution pension plan, a termination benefit, and a non-compete
indemnity.
Such arrangements are part of the overall compensation package generally awarded to executive officers; in line with the
recommendations of the AFEP-MEDEF code, there are very strict rules about how they are implemented. The termination benefit
and non-compete indemnity are intended to compensate for the fact that the Chief Executive Officer may be dismissed at any
time.
Each of those benefits is taken into account by the Board of Directors when fixing the overall compensation of the Chief
Executive Officer.
Given the decision by our Board of Directors to relieve Paul Hudson of his duties as Chief Executive Officer effective end-of-day
on February 17, 2026, he will receive a termination benefit and a non-compete indemnity. The financial terms of Paul Hudson's
termination arrangements will be communicated in a Report on Form 6K and published on Sanofi's corporate website, that will
also include the compensation policies for Olivier Charmeil (appointed as Interim Chief Executive Officer as of February 18, 2026)
and Belén Garijo (who will assume office as Chief Executive Officer after the Annual General Meeting of April 29, 2026.
SANOFI FORM 20-F 2025 | 121 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Pension arrangements
The Chief Executive Officer is entitled to benefits under the top-up defined-contribution pension plan introduced within Sanofi
on January 1, 2020. This is a collective plan falling within the scope of Article 82 of the French General Tax Code. It is also offered
to members of our Executive Committee and to all senior executives whose position is classified within the Sanofi grade scale
as “Executive Level 1 or 2”. The Chief Executive Officer’s entitlement under this plan may be withdrawn by a decision of the Board
of Directors, but not retroactively.
Under the terms of the plan, the Chief Executive Officer receives an annual contribution the amount of which (subject to
attainment of a performance condition) may be up to 25% of his reference compensation (annual fixed and variable cash-based
compensation only; all other compensation is excluded). The rights accruing under the plan are those that are generated by the
capitalization contract taken out with the insurer, and vest even if the Chief Executive Officer does not remain with Sanofi until
retirement. The Chief Executive Officer may elect for the rights to be transferable as a survivor’s pension.
The performance condition is as follows:
•if the level of attainment for variable compensation is equal to or greater than the target (i.e. 150% of fixed compensation),
100% of the contribution is paid;
•if the level of attainment for variable compensation is less than 100% of fixed compensation, no contribution is paid; and
•between those two limits, the contribution is calculated on a pro rata basis.
Because this performance condition is linked to the attainment of the performance criteria for annual variable compensation
(which itself is determined with reference to the strategic objectives of Sanofi), it ensures that no pension contributions could be
made in the event that the Chief Executive Officer fails to deliver.
The plan is wholly funded by Sanofi, which pays the full amount of the gross contributions. Because it is treated as equivalent to
compensation, the contribution is subject to payroll taxes and employer’s social security charges, and to income tax in the hands
of the Chief Executive Officer; all of the above are charged on the basis of the bands, rates and other conditions applicable to
compensation, and paid and declared on his pay slips for the contribution period.
Subject to (i) formal confirmation by the Board of Directors that the performance condition for the previous year has been met
and (ii) approval of the Chief Executive Officer’s compensation package for that year by the Annual General Meeting of our
shareholders, the annual gross contribution is paid as follows:
•50% as a gross insurance premium to the fund manager; and
•50% to the Chief Executive Officer, to indemnify him for the social security and tax charges for which he will become
immediately liable.
In accordance with Article 39.5 bis of the French General Tax Code, deferred compensation as defined in section 4 of
Article L. 22-10-9.4 of the French Commercial Code can be offset against corporate profits as a taxable expense up to a limit set
at three times the annual social security ceiling per beneficiary.
The pension entitlement is not cumulative with (i) any termination benefit paid in the event of forced departure or (ii) any
non-compete indemnity.
Termination arrangements
The termination benefit only becomes payable if the departure of the Chief Executive Officer is forced, i.e. in the event of
removal from office or resignation linked to a change in strategy or control of Sanofi. Compensation for non-renewal of the term
of office is irrelevant in the case of the Chief Executive Officer, because this office is held for an indefinite term.
In addition, no termination benefit is payable and the arrangement is deemed to have been rescinded in the following
circumstances:
•removal from office for gross or serious misconduct (faute grave ou lourde);
•if the Chief Executive Officer elects to leave Sanofi to take up another position;
•if the Chief Executive Officer is assigned to another position within Sanofi; or
•if the Chief Executive Officer takes his pension.
Payment of the termination benefit is contingent upon fulfillment of a performance condition, which is deemed to have been met
if the attainment rate for the individual variable compensation objectives exceeded 90% of the target; that condition is assessed
over the three financial years preceding the Chief Executive Officer leaving office.
The amount of the termination benefit is capped at 24 months of the Chief Executive Officer’s most recent total compensation
on the basis of (i) the fixed compensation effective on the date of leaving office and (ii) the last variable compensation received
prior to that date subject to fulfillment of the performance condition.
The amount of the termination benefit is reduced by any amount received as consideration for the non-compete undertaking,
such that the aggregate amount of those two benefits may never exceed two years of total fixed and variable compensation.
122 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Non-compete undertaking
In the event of his departure from Sanofi, the Chief Executive Officer undertakes, during the 12-month period following his
departure, not to join a competitor of Sanofi as an employee or corporate officer, or to provide services to or cooperate with such
a competitor.
In return for this undertaking, he receives an indemnity corresponding to one year’s total compensation, based on his fixed
compensation effective on the day he leaves office and on the last individual variable compensation he received prior to that
date. This indemnity is payable in 12 monthly installments.
However, the Board of Directors reserves the right to release the Chief Executive Officer from that undertaking for some or all of
that 12-month period. In such cases, the non-compete indemnity would not be due for the period of time waived by the
Company.
Consequences of the Chief Executive Officer’s departure for equity-based compensation
If the Chief Executive Officer leaves Sanofi for reasons other than resignation or removal from office for gross or serious
misconduct (in which case any award of equity-based compensation is forfeited in full), the overall allocation percentage is
prorated to reflect the amount of time the Chief Executive Officer remained with Sanofi during the vesting period.
If at any time prior to the expiration of the vesting period of his performance shares the Chief Executive Officer joins a competitor
of Sanofi as an employee or corporate officer, or provides services to or cooperates with such a competitor, he irrevocably loses
those performance shares regardless of any full or partial discharge by the Board of Directors of the non-compete undertaking
relating to his office as Chief Executive Officer.
If the Chief Executive Officer retires at the statutory retirement age prior to the expiration of the vesting period of his
performance shares, the overall allocation rate will be apportioned on a pro rata basis to reflect the amount of time for which the
Chief Executive Officer remained in the employment of Sanofi during the vesting period.
Summary of benefits awarded to the Chief Executive Officer on leaving office
The table below presents a summary of the benefits (as described above) that could be claimed by the Chief Executive Officer on
leaving office, depending on the terms of his departure. The information provided in this summary is without prejudice to any
decisions that may be made by the Board of Directors.
Voluntary departure/Removal from office for gross or serious misconduct | Forced departure | Retirement | |
Termination benefit(a) | / | 24 months of fixed compensation as of the date of leaving office + 24 months of most recent individual variable compensation received(d) – Amounts received as non-compete indemnity | / |
Non-compete indemnity(b) | 12 months of fixed compensation as of the date of leaving office + 12 months of most recent individual variable compensation received prior to leaving office | 12 months of fixed compensation as of date of leaving office + 12 months of most recent individual variable compensation received prior to leaving office(e) | / |
Top-up pension(c) | / | / | Annual contribution of up to 25% of reference compensation |
Performance share plans not yet vested | Forfeited in full | Rights retained pro rata to period of employment within Sanofi(f) | Rights retained pro rata to period of employment within Sanofi(f) |
(a)The amount of the termination benefit is reduced by any indemnity received as consideration for the non-compete undertaking, such that the
aggregate amount of those two benefits may never exceed two years of total fixed and variable compensation.
(b)The Board of Directors may decide to release the Chief Executive Officer from the non-compete undertaking for some or all of the 12-month period. In
that case, the non-compete indemnity would not be due, or would be scaled down proportionately.
(c)Defined-contribution pension plan, within the scope of Article 82 of the French General Tax Code. Subject to fulfillment of the performance condition,
assessed annually.
(d)Subject to fulfillment of the performance condition assessed over the three financial years preceding departure from office, as described above.
(e)Subject to the Board of Directors enforcing the non-compete undertaking, the amount of the termination benefit is reduced by any indemnity received as
consideration for the non-compete undertaking, such that the aggregate amount of those two benefits may never exceed two years of total fixed and
variable compensation.
(f)In this case, the Chief Executive Officer remains subject to the terms of the plans, including the performance conditions and the non-compete clause.
SANOFI FORM 20-F 2025 | 123 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Policy to recover erroneously-awarded compensation (“clawback”)
In 2023, the NASDAQ listing rules were amended to include Rule 5608, in application of Section 10D-1 of the Securities Exchange
Act of 1934 which requires listed companies to implement a clawback policy.
On October 26, 2023, our Board of Directors adopted a clawback policy under which Sanofi must, within a reasonable
time-frame, recover the portion of the Chief Executive Officer’s variable compensation (cash-based or equity-based) that is
wholly or partly contingent on the attainment of financial performance criteria and was paid to him (according to the definition
contained in the NASDAQ listing rules) based on financial information that has been determined to be erroneous and has required
accounting restatement to correct an error in previously-published financial statements. The policy applies to compensation paid
on or after October 2, 2023.
The clawback policy also applies to members of our Executive Committee and to our Head of Consolidation (equivalent to the
Chief Accounting Officer within the meaning of the NASDAQ listing rules).
Summary of changes made to the compensation policy for Paul Hudson
The table below summarizes adjustments made to the compensation policy for the Chief Executive Officer and to the content of
the information published in the compensation report, some of which have been discussed in depth with our shareholders.
2026 | 2025 |
•Annual variable compensation: –Narrative explanations of the use of benchmarks reviewed, and information provided to a higher degree of granularity. –Transparency of performance objectives, especially CSR objectives, enhanced | •Annual fixed compensation: –Annual fixed compensation is increased from €1,400,000 to €1,600,000 gross starting from 2025. •Equity-based compensation: –Given the increase in the number of performance shares awarded to the Chief Executive Officer in respect of 2025, increase in the weighting of the TSR criterion from 20% to 30%. To enable the TSR weighting to increase to 30%, the Business EPS weighting was reduced from 35% to 30%, and the Free Cash Flow weighting from 25% to 20%; the R&D and CSR criteria remained unchanged. Furthermore, in order to align with market practices, the Board of Directors decided to review the mechanism so as to reward Sanofi's relative positioning vis-à-vis the peer panel. •Transparency on performance criteria applicable to annual variable compensation: –Greater transparency on the financial performance criteria applicable to annual variable compensation: information about the thresholds (floor, target and maximum attainment level) used by the Board of Directors to determine the overall attainment level and payout is now published for each criterion. |
Arrangements in favor of executive officers in office as of December 31, 2025 (table No. 11 of the AFEP-MEDEF Code)
Executive officer | Contract of employment | Top-up pension plan | Indemnities or benefits payable or potentially payable on cessation of office | Indemnities payable under non-compete clause |
Chairman of the Board | No | No | No | No |
Chief Executive Officer | No | Yes | Yes | Yes |
Compensation and benefits of all kinds awardable to corporate officers in respect of 2026
The section below describes the components of the compensation and benefits of all kinds awardable to corporate officers in
respect of the 2026 financial year, pursuant to the compensation policies described in “— Compensation policy for corporate
officers” above.
Compensation and benefits of all kinds awardable to directors in respect of 2026
The amounts to be awarded to directors in respect of 2026 will be determined in accordance with the principles described above
in “— Compensation policy for corporate officers — Compensation policy for directors.”
Compensation and benefits of all kinds awardable in respect of 2026 to the Chairman of the Board
of Directors
The components of compensation awardable to the Chairman of the Board of Directors are described above in
“— Compensation policy for corporate officers — Compensation policy for the Chairman of the Board of Directors.”
Acting on a recommendation from the Compensation Committee, the Board of Directors meeting of February 11, 2026 decided to
maintain the amount of compensation payable to the Chairman of the Board of Directors at €880,000 gross.
The Chairman of the Board of Directors does not receive any variable compensation, stock options or performance shares, in
accordance with AMF recommendations. Nor does he receive any compensation (i) for serving as a director or (ii) from any
company included in Sanofi’s scope of consolidation within the meaning of Article L. 233-16 of the French Commercial Code.
Benefits in kind for 2026 comprise a company car with a driver.
124 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Compensation and benefits of all kinds awardable in respect of 2026 to Paul Hudson
Fixed and variable annual compensation
Acting on a recommendation from the Compensation Committee, the Board of Directors meeting of February 11, 2026
determined the components of Paul Hudson’s compensation for the 2026 financial year.
Paul Hudson’s annual compensation comprises (i) annual fixed gross compensation of €1,600,000 (see the explanations provided
under “— Compensation policy for corporate officers — Compensation policy for the Chief Executive Officer” above) and
(ii) annual variable compensation in a range from 0% to 250% of his annual fixed compensation, with a target of 150%, and subject
to both quantitative and qualitative criteria.
The objectives are based 60% on financial indicators – sales growth, FCF and business EPS – each accounting for 20%.
Floors have been set for each financial criterion, below which no variable compensation is payable for that criterion.
Objectives based on financial indicators – unchanged for 2026 | |||
2026 | 2025 | ||
Sales growth | 20% | Sales growth | 20% |
FCF | 20% | FCF | 20% |
Business EPS | 20% | Business EPS | 20% |
TOTAL | 60% | 60% | |
The structure of individual objectives, which is a mix of quantitative and qualitative objectives, was streamlined with effect from
2025.
Individual objectives for 2026 and 2025 are shown below:
2026 individual objectives | 2025 individual objectives * | ||
Portfolio and Assets (Asset Portfolio and Business Development/M&A) | 7.5% | Business transformation (Reallocation of Pipeline Resources, Centralization, Hub Strategy, Smart Spending, Asset Portfolio, Digital Transformation) | 15% |
Digital Transformation and Artificial Intelligence (Delivery of AI agenda in R&D and commercial operations, development of a data strategy) | 7.5% | ||
Development pipeline (Key regulatory and development milestones for high value creation assets, global portfolio KPIs focused on execution, value creation and innovation) | 15% | Development pipeline M1 (Lead selection), M2 (Candidate selection), First in Human, Pivotal Studies, Submissions, Approvals | 15% |
CSR (People , Environment, Governance (functioning of Executive Committee and interactions with the Board of Directors) | 10% | CSR People & Culture, Environment, Governance (reinforcement of the strategic dialogue with the Board of Directors and functioning of the new Executive Committee) | 10% |
(*)For details of individual objectives for 2025 refer to "— Compensation and benefits of all kinds paid during 2025 or awarded in respect of 2025 to Paul
Hudson" below.
Equity-based compensation
Given the decision by our Board of Directors to relieve Paul Hudson of his duties as Chief Executive Officer effective end-of-day
on February 17, 2026, it has been decided that he would not be awarded any performance shares in respect of 2026.
Compensation and benefits of all kinds paid during 2025 or awarded in respect of 2025 to corporate officers
The section below constitutes the report on compensation of corporate officers required by Articles L. 225-37 and L. 22-10-8 of
the French Commercial Code. The arrangements described therein will be submitted for approval by our shareholders at the
Annual General Meeting called to approve the financial statements for the year ended December 31, 2025 pursuant to
Article L. 22-10-34 of the French Commercial Code.
Compensation elements and benefits of all kinds paid during 2025 or awarded in respect of 2025 to directors
The compensation policy for directors (as described above in the section entitled “— Compensation policy for directors”) defines
the fixed amount of compensation, and the principles for allocating the variable portion between directors, up to the limit of the
overall amount approved by the Annual General Meeting.
Directors’ compensation includes an annual fixed payment, apportioned on a time basis for directors who assumed or left office
during the year; and a variable amount, allocated by the Board according to actual attendance at Board and Committee
meetings. As required by the AFEP-MEDEF Code, directors’ compensation is allocated predominantly on a variable basis.
For 2025, directors’ compensation was determined in accordance with the compensation policy for directors as described above
in the section entitled “— Compensation policy for directors.”
SANOFI FORM 20-F 2025 | 125 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Compensation allocated to directors for serving as directors (table No. 3 of the AFEP-MEDEF Code)
The table below shows amounts paid in respect of 2025 and 2024 to each member of our Board of Directors, including those
whose term of office ended during those years.
Directors’ compensation for 2024, the amount of which was approved at the Board meeting of February 12, 2025, was partially
paid in July 2024, with an additional payment made in 2025.
Directors’ compensation for 2025, the amount of which was approved at the Board meeting of February 11, 2026, was partially
paid in July 2025, with an additional payment to be made in 2026.
(€) | Compensation in respect of 2025 | Compensation in respect of 2024 | |||||
Name | Fixed portion | Variable portion | Total amount (variable + fixed portion) | Total gross compensation apportioned on a pro rata basis(*) | Fixed portion | Variable portion | Total gross compensation |
Frédéric Oudéa | — | — | — | — | — | — | — |
Christophe Babule | 30,000 | 126,500 | 156,500 | 150,019 | 30,000 | 132,000 | 162,000 |
Clotilde Delbos | 30,000 | 167,750 | 197,750 | 189,561 | 20,000 | 104,500 | 124,500 |
Humberto de Sousa(a)(b)(c)(d) | 20,000 | 38,500 | 58,500 | 56,078 | N/A | N/A | N/A |
Rachel Duan(e) | 30,000 | 121,000 | 151,000 | 144,747 | 30,000 | 115,500 | 145,500 |
Carole Ferrand | 30,000 | 178,750 | 208,750 | 200,106 | 30,000 | 167,750 | 197,750 |
Lise Kingo(f) | 30,000 | 132,000 | 162,000 | 155,292 | 30,000 | 137,500 | 167,500 |
Jean-Paul Kress | 30,000 | 187,000 | 217,000 | 208,014 | N/A | N/A | N/A |
Patrick Kron | 30,000 | 203,500 | 233,500 | 223,831 | 30,000 | 165,000 | 195,000 |
Wolfgang Laux(c) | 30,000 | 99,000 | 129,000 | 123,658 | 30,000 | 99,000 | 129,000 |
Barbara Lavernos | 30,000 | 132,000 | 162,000 | 155,292 | 30,000 | 126,500 | 156,500 |
Fabienne Lecorvaisier(g) | 10,000 | 63,250 | 73,250 | 73,250 | 30,000 | 140,250 | 170,250 |
Anne-Françoise Nesmes(e) | 30,000 | 154,000 | 184,000 | 176,381 | 20,000 | 104,500 | 124,500 |
John Sundy(e) | 30,000 | 170,500 | 200,500 | 192,197 | 20,000 | 93,500 | 113,500 |
Emile Voest(f) | 30,000 | 156,750 | 186,750 | 179,017 | 30,000 | 129,250 | 159,250 |
Antoine Yver | 30,000 | 198,000 | 228,000 | 218,559 | 30,000 | 154,000 | 184,000 |
Yann Tran(c)(d)(g) | 10,000 | 44,000 | 54,000 | 54,000 | 30,000 | 82,500 | 112,500 |
Gilles Schnepp(h) | N/A | N/A | N/A | N/A | 30,000 | 165,000 | 195,000 |
Diane Souza(i) | N/A | N/A | N/A | N/A | 10,000 | 68,750 | 78,750 |
Thomas Südhof(i) | N/A | N/A | N/A | N/A | 10,000 | 55,000 | 65,000 |
Total | 430,000 | 2,172,500 | 2,602,500 | 2,500,000 | 440,000 | 2,040,500 | 2,480,500 |
(*)Due to the high number of Board and committee meetings, the theoretical amount of compensation payable to directors exceeded the maximum
amount set by the Annual General Meeting of our shareholders. Consequently, the amount payable to each director was scaled down on a pro rata
basis, as explained above.
The amounts reported are gross amounts before taxes.
(a) Humberto de Sousa joined the Board on April 30, 2025.
(b) Director appointed by the CFDT, the leading trade union organization within Sanofi in France.
(c)Director representing employees.
(d)Compensation due to Yann Tran and Humberto de Sousa is paid directly to Fédération Chimie Énergie CFDT.
(e)Director resident outside Europe.
(f)Director resident outside France but within Europe.
(g) Fabienne Lecorvaisier and Yann Tran left the Board on April 30, 2025.
(h) Gilles Schnepp left the Board on December 31, 2024.
(i)Diane Souza and Thomas Südhof left the Board on April 30, 2024.
Each of the two directors representing employees has a contract of employment with a Sanofi subsidiary, under which they
receive compensation unrelated to their office as director. Consequently, that remuneration is not disclosed.
Variable compensation allocated to directors in respect of 2025 represented 83.48% of their total compensation.
126 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Compensation and benefits of all kinds paid during 2025 or awarded in respect of 2025
to Frédéric Oudéa, Chairman of the Board of Directors
Frédéric Oudéa was appointed Chairman of the Board of Directors on May 25, 2023. He does not have a contract of employment
with Sanofi.
As Chairman of the Board, Frédéric Oudéa is a member of the Appointments, Governance and CSR Committee and the Scientific
Committee, and Chair of the Strategy Committee.
The remit of the Chairman of the Board is specified in the Board Charter, which is reproduced in its entirety in Exhibit 1.2. to this
annual report.
During 2025, the activities of Frédéric Oudéa as Chairman of the Board of Directors included:
•chairing meetings of the Board of Directors (twelve meetings, not including the two Strategy Seminars), attending meetings of
Committees of which he is a member (seven meetings of the Appointments, Governance and CSR Committee, three meetings
of the Strategy Committee, eleven meetings of the Scientific Committee, and three joint meetings of those two committees),
and attending Compensation Committee meetings and the R&D pipeline review week;
•organizing and chairing the strategy seminars held in April and October 2025;
•monitoring of the proper implementation of the decisions taken by the Board;
•meetings with directors, including (i) in connection with the evaluation of the Board’s operating procedures, (ii) on matters
relating to the projects presented to the Board, and (iii) on corporate governance matters;
•regular meetings with the members of the Executive Committee;
•meetings with Sanofi employees and visits to subsidiaries of Sanofi;
•meetings with biotech and medtech companies; and
•representing Sanofi at events or official meetings (in France and abroad) with representatives of the public authorities and
other stakeholders, in line with his remit as defined by the Board Charter.
The Chairman also has a role in explaining positions taken by the Board within its sphere of competence, especially in terms of
strategy, governance and executive compensation. In furtherance of this role, the Chairman drew on his experience of corporate
communications in:
•holding meetings with certain shareholders; and
•answering letters from investors and shareholders.
Those tasks were carried out in coordination with the Chief Executive Officer.
Compensation paid in respect of the 2025 financial year
Acting on a recommendation from the Compensation Committee, the Board meeting of February 11, 2026 noted the components
of Frédéric Oudéa's compensation for the 2025 financial year. For that year, Frédéric Oudéa's fixed compensation was
unchanged from the 2024 financial year at €880,000 gross.
In line with our compensation policy for the Chairman of the Board, Frédéric Oudéa did not receive any variable compensation,
and was not awarded any stock options or performance shares. He received no compensation for serving as a director, and no
compensation from any company included in Sanofi’s scope of consolidation within the meaning of Article L. 233-16 of the
French Commercial Code.
Benefits in kind amounted to €4,836, and relate to a company car with a driver.
Frédéric Oudéa is not covered by the Sanofi defined-contribution pension plan.
Compensation, options and shares awarded to Frédéric Oudéa
(table No. 1 of the AFEP-MEDEF Code)
(€) | 2025 | 2024 |
Compensation awarded for the year (details provided in the following table) | 884,836 | 884,836 |
Valuation of stock options awarded during the year | N/A | N/A |
Valuation of performance shares awarded during the year | N/A | N/A |
Valuation of other long-term compensation plans | N/A | N/A |
Total | 884,836 | 884,836 |
SANOFI FORM 20-F 2025 | 127 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Compensation awarded to Frédéric Oudéa
(table No. 2 of the AFEP-MEDEF Code)
2025 | 2024 | |||
(€) | Amounts due | Amounts paid | Amounts due | Amounts paid |
Fixed compensation(a) | 880,000 | 880,000 | 880,000 | 880,000 |
Annual variable compensation | N/A | N/A | N/A | N/A |
Exceptional compensation | N/A | N/A | N/A | N/A |
Compensation for serving as a director | N/A | N/A | N/A | N/A |
Benefits in kind | 4,836 | 4,836 | 4,836 | 4,836 |
Total | 884,836 | 884,836 | 884,836 | 884,836 |
The amounts reported are gross amounts before taxes.
(a)Fixed compensation due in respect of a given year is paid during that year.
Compensation and benefits of all kinds paid during 2025 or awarded in respect of 2025 to Paul Hudson
Paul Hudson will serve as Chief Executive Officer until end-of-day on February 17, 2026.
Paul Hudson does not have a contract of employment with Sanofi, and receives no compensation from any company included in
Sanofi’s scope of consolidation within the meaning of Article L. 233-16 of the French Commercial Code.
Compensation awarded to Paul Hudson
(table No. 1 of the AFEP-MEDEF Code)
(€) | 2025 | 2024 |
Compensation awarded for the year (details provided in the following table) | 4,229,497 | 3,979,697 |
Valuation of performance shares awarded during the year(a) | 6,759,000 | 5,971,350 |
Total | 10,988,497 | 9,951,047 |
(a)Weighting between (i) fair value determined using the Monte Carlo model and (ii) market price of Sanofi shares at the date of grant, adjusted for
dividends expected during the vesting period.
The parameters used to calculate the valuations are market parameters available in the financial press.
Fixed and variable compensation awarded to Paul Hudson
(table No. 2 of the AFEP-MEDEF Code)
2025 | 2024 | |||
(€) | Amounts due | Amounts paid | Amounts due | Amounts paid |
Fixed compensation(a) | 1,600,000 | 1,600,000 | 1,400,000 | 1,400,000 |
Annual variable compensation(b) | 2,616,000 | 2,566,200 | 2,566,200 | 2,379,300 |
Cash bonus (sign-on bonus) | N/A | N/A | N/A | N/A |
Exceptional compensation | N/A | N/A | N/A | N/A |
Compensation for serving as a director | N/A | N/A | N/A | N/A |
Benefits in kind | 13,497 | 13,497 | 13,497 | 13,497 |
Total | 4,229,497 | 4,179,697 | 3,979,697 | 3,792,797 |
The amounts reported are gross amounts before taxes.
(a)Fixed compensation due in respect of a given year is paid during that year.
(b)Variable compensation in respect of a given year is determined at the start of the following year and paid after the Annual General Meeting in that year,
subject to shareholder approval.
128 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Fixed and variable compensation
Acting on a recommendation from the Compensation Committee, the Board meeting of February 11, 2026 determined the
components of Paul Hudson’s compensation for the 2025 financial year.
In accordance with the compensation policy for the Chief Executive Officer as approved by the Annual General Meeting of
Sanofi's shareholders on April 30, 2025, his annual compensation for 2025 comprises (i) annual fixed gross compensation of
€1,600,000; and (ii) annual variable compensation in a range from 0% to 250% of his annual fixed compensation, with a target of
150%, and subject to both quantitative and qualitative criteria.
The objectives applicable to annual variable compensation in respect of 2025 were:
•60% based on financial indicators: sales growth, FCF and Business EPS, each accounting for 20%; and
•40% based on specific individual objectives. For 2025, the individual objectives set by the Board were:
–business transformation (15%) – quantitative and qualitative objective;
–development pipeline (15%) – quantitative objective; and
–CSR (10%) – quantitative and qualitative objective.
In the interests of transparency, Sanofi discloses, for each financial criterion, information about the thresholds (floor, target and
maximum attainment level) used by the Board of Directors to determine the overall attainment level and payout in respect of the
past financial year.
Objective | Measured against | Payout | ||
Threshold (floor) Payout = 0% | Target (X, in %) Payout = 100% | Maximum payout = 166.67% | ||
Attainment level | ||||
Sales growth | Growth versus 2025 budget | X -4 percentage points | 100% | X +4 percentage points |
Business EPS | Attainment level versus 2025 budget | X -5 percentage points | 100% | X +5 percentage points |
FCF | Growth versus 2025 budget | X -15 percentage points | 100% | X +50 percentage points |
Likewise, at the start of each year, the Board of Directors establishes a precise matrix for determining each of the individual
objectives. Sanofi discloses the content of the qualitative criteria, accompanied by narrative for each sub-criterion explaining the
level of attainment reached. Those criteria are always assessed by reference to the performances of the leading global
pharmaceutical companies.
Sanofi also publishes such information for the People & Culture and Environment sub-criteria:
Objective | Measured against | Payout | ||
Threshold (floor) Payout = 0% | Target (X, in %) Payout = 100% | Maximum payout = 150% | ||
Attainment level | ||||
Culture change: engagement score | Progress relative to 2024 score (scale from 0 to 10) | 2024 score | 2024 score + 0.1 percentage points | 2024 score + 0.2 percentage points |
Equal representation of men and women among candidates for succession to senior management posts | Equal representation | 48% women | Equal representation | N/A |
Reduction in CO2 emissions (Scopes 1 & 2) between Q3 2024 and Q3 2025 | Reduction versus 2025 objective | X + 2 percentage points | 100% | X - 5 percentage points |
Reduction in CO2 emissions (Scope 3) between Q3 2024 and Q3 2025 | Reduction versus 2025 objective | X + 0.9 percentage points | 100% | X - 2.7 percentage points |
SANOFI FORM 20-F 2025 | 129 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Acting on a proposal from the Compensation Committee, the Board meeting of February 11, 2026 reviewed the attainment level
of each criterion and sub-criterion. The Board’s conclusions are summarized in the table below.
Criterion | Type | Weight | Target/ Maximum (as % of fixed compensation) | 2025 Attainment level | 2024 reference | Comments | Payout (as % of fixed compensation) | |
Financial objectives | ||||||||
Sales growth(a) | Quantitative | 20% | 30%/5O% | 136.11% | 158.56% | Confidential target, Performance above budget | 40.83% | |
Business earnings per share (Business EPS)(a) | Quantitative | 20% | 30%/50% | 104.27% | 112.54% | Confidential target, Performance above budget | 31.28% | |
Free cash flow | Quantitative | 20% | 30%/50% | 117.51% | 116.92% | Confidential target, Performance above budget | 35.25% | |
Individual objectives | ||||||||
Business Transformation | Quantitative / Qualitative | 15.0% | 22.5%/37.5% | 101.83% | 102.17% | Overall Business •The Smart spending program exceeded the target, driven by successful execution in particular: • Commercial operations transformation (Other Medicines) • Realignment of R&D footprint • Commercial operations transition. | 22.92% | |
Manufacturing and Supply •Successful implementation of the Manufacturing and Supply Operating Model with key performance outcomes improved across Safety, Quality, Supply and Cost. | ||||||||
Asset Portfolio •Successful separation of Opella •Acquisition of Blueprint, ViceBio, Vigil, DrenBio, and Dynavax •20 new equity investments completed •China strategy: acquisition of Phase 3 cardiovascular medicines, and two partnership investments in local funds executed | ||||||||
Digital •In R&D: –90% targets in the pipeline now being credentialed using our data and AI systems –100% small and large molecule drug design efforts now supported by AI/ML methods, doubling molecular throughput of research teams •In Manufacturing & Supply: –66% achieved on the modernization index trajectory for our digital roadmap –Inventory optimization, with landing target slightly missed –Launch acceleration: 96% measuring Process Performance Qualification (PPQ) RFT (right- first time) vs 95% target. | ||||||||
Development Pipeline | Quantitative | 15% | 22.5%/37.5% | 90.00% | 118.50% | R&D achieved below execution focused KPI with: •22 submissions and 20 regulatory approvals in different indications across major regions •9 priority reviews and 22 regulatory designations received •Increased productivity in clinical development: 12 Phase 3 and 15 Phase 2 studies initiated, 6 new molecular (NMEs) or vaccines (NVEs) entities entered the clinical development phase (First In Human - FIH) •Scientific research: 16 entries into M1, nine development candidates into M2 •Reinforcement of the pipeline through business development and acquisitions: 35 new BD partnerships (25 pharma, 5 vaccines, and 5 out- licensing) signed | 20.25% | |
130 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Criterion | Type | Weight | Target/ Maximum (as % of fixed compensation) | 2025 Attainment level | 2024 reference | Comments | Payout (as % of fixed compensation) | |
CSR / ESG | Quantitative / Qualitative | 10% | 15%/25% | 86.63% | 114.58% | People & Culture: •Continued progress on Sanofi culture shift with global engagement score increased vs 2024. •Women in succession plans for executive roles who are ready within 1-2 years represent 50.8% of the population, the objective being 50%. | 13.00% | |
Environmental •CO2 (Scope 1&2) reduction between Q3 2024 and Q3 2025 = 9%. •Objective on Scope 3 not achieved. | ||||||||
Governance •Active Executive Committee participation in 2 strategic seminars, along with site visits (e.g. Vitry, Morristown), have strengthened communication channels and collaboration between Executive Committee and the Board of Directors. | ||||||||
Total | 100% | 150%/250% | 100% | 122.20% | 163.53% | |||
(a)In 2025, it was agreed that for the purpose of calculating the attainment of quantitative criteria, the performance figures would be adjusted to
eliminate impacts related to (i) the acquisition of Blueprint and (ii) share buybacks; those adjustments negatively affected Sales Growth and Business
EPS.
Acting on a recommendation from the Compensation Committee, the Board meeting of February 11, 2026 set Paul Hudson’s
variable compensation for 2025 at €2,616,000 gross, equivalent to 163.53% of his fixed compensation.
Payment of Paul Hudson’s variable compensation in respect of the 2025 financial year is contingent on approval of his
compensation package by the shareholders in an Ordinary General Meeting, on the terms stipulated in Article L. 22-10-34 II of the
French Commercial Code.
Equity-based compensation
Using the authorization granted by our shareholders via the twentieth resolution of the Annual General Meeting of April 30, 2024,
the Board meeting held on April 30, 2025 decided, acting on the recommendation of the Compensation Committee, to award
Paul Hudson 90,000 performance shares in respect of 2025. The valuation of that award as of April 30, 2025, determined in
accordance with IFRS and incorporating a market-related condition, was €6,759,000, equivalent to 4.22 times his fixed
compensation.
The entire amount of the award is contingent upon the attainment of performance objectives based on (i) internal criteria based
on business earnings per share (Business EPS), free cash flow (FCF), corporate social responsibility (CSR) and the R&D pipeline,
and (ii) an external criterion based on improvement in total shareholder return (TSR) relative to that of a benchmark panel of
12 leading global pharmaceutical companies (plus Sanofi): Amgen Inc., AstraZeneca plc, Bayer AG, Bristol-Myers Squibb Inc., Eli
Lilly and Company Inc., GlaxoSmithKline plc, Johnson & Johnson Inc., Merck & Co. Inc., Novartis AG, Novo Nordisk A/S, Pfizer Inc.,
and Roche Holding AG.
To align equity-based compensation on our medium-term performance, a three-year period (2025-2027) is used to measure
performance.
The above criteria were selected because they align medium-term equity-based compensation on the strategy adopted by
Sanofi.
The arrangements relating to these awards are as follows:
•The Business EPS criterion accounts for 30% of the award (Business EPS represents Sanofi's “business net income” divided by
the number of Sanofi shares), and is determined as the average actual-to-budget ratio of Business EPS attained over the
entire vesting period at constant exchange rates.
The objective cannot be less than the lower end of the range of the annual guidance announced publicly by Sanofi at the start
of each year. If the attainment level is less than 95%, no payment will be made for this criterion.
Business EPS actual-to-budget attainment level (B) | Business EPS allocation rate |
If B < 95% | 0% |
If B = 95% | 50% |
If B is > 95% but < 98% | (50 + [(B - 95) x 16])% |
If B is ≥ 98% but ≤ 105% | B% |
If B is > 105% but < 110% | (105 + [(B - 105) x 3])% |
If B is ≥ 110% | 120% |
(1)Amgen Inc., AstraZeneca plc, Bayer AG, Bristol-Myers-Squibb Inc., Eli Lilly and Company Inc., GlaxoSmithKline plc, Johnson & Johnson Inc., Merck & Co.
Inc., Novartis AG, Novo Nordisk A/S, Pfizer Inc., and Roche Holding AG. The Board of Directors may review the composition of the panel during the
measurement period in exceptional circumstances (dissolution or merger of a panel company).
(2)Historical values are adjusted for spin-offs, stock splits/reverse stock splits, scrip dividends/bonus issues, rights issues, etc.
SANOFI FORM 20-F 2025 | 131 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
•The FCF criterion accounts for 20% of the award. This criterion was selected because it is aligned with Sanofi’s current
strategic objectives, and is transparent both within and outside the company.
The FCF criterion represents the average actual-to-budget FCF ratio attained over the entire period. The award is based on a
target FCF, below which some or all of the performance shares are forfeited; if the attainment level is less than 70%, no
payment will be made for this criterion.
FCF actual-to-budget attainment level (F) | FCF allocation rate |
If F is ≤ 70% | 0% |
If F is > 70% but < 80% | [(F - 70) x 5]% |
If F = 80% | 50% |
If F is > 80% but < 100% | (50 + [(F – 80) x 2.5])% |
If F = 100% | 100% |
If F is > 100% but < 120% | F% |
If F is ≥ 120% | 120% |
•The TSR criterion accounts for 30% of the award. This performance criterion compares Sanofi's three-year TSR performance
with the median TSR of comparable companies included in a peer panel of 12 pharmaceutical companies(1) over the same
period. Sanofi's TSR corresponds to the performance of the Sanofi share price(2) uplifted by dividends per share during the
measurement periods, without reinvestment.
TSR calculation
The TSR of each company is calculated using the following formula:
(Average 2027 share price – Average 2024 share price + Dividends per share 2025-2027) / Average 2024 share price
Where:
–"Average 2027 share price" is the average of the opening share prices from January 1, 2027 through December 31, 2027;
–"Average 2024 share price" is the average of the opening share prices from January 1, 2024 through December 31, 2024;
and
–"Dividends per share 2025-2027" is the sum total of dividends paid out on the shares of each company from January 1,
2025 through December 31, 2027, without reinvestment.
The median TSR is the performance of the company ranked 7th within the peer panel.
At the end of the period, the difference between the Sanofi TSR and the median TSR is measured in percentage points, and
the Board of Directors will determine the TSR Allocation Rate as follows:
Difference in TSR performance ("D") | TSR Allocation Rate |
If D is less than 0% | 0% |
If D is 0% | 75% |
If D is greater than 0% and less than +20% | 75%+(Dx3.75) |
If D is greater than or equal to +20% | 150% |
No TSR allocation may be made if Sanofi's TSR is lower than the median TSR.
•The CSR criterion accounts for 10% of the award. This performance condition equates to the attainment over a three-year
period of annual objectives plus a "stretch" objective, linked to the following pillars of Sanofi’s CSR strategy:
1.Affordable Access: providing essential medicines to non-communicable disease patients through Sanofi Global Health; and
2.Planet Care: Carbon Emissions Reduction, scopes 1 & 2 (reduction in emissions vs 2019).
Attainment of each annual CSR objective will earn one performance point; a maximum of three points, plus one extra point
linked to the "stretch" objective, can be earned for each CSR pillar. For each criterion, attainment of the objectives for 2027
will earn three points even if the annual objectives were not attained.
132 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
At the end of the period, the Board of Directors will determine the CSR Allocation Rate corresponding to the number of points
earned, as shown below:
CSR points earned | CSR Allocation Rate |
Less than 3 points | 0% |
3 points | 50% |
4 points | 67% |
5 points | 83% |
6 points | 100% |
7 points | 110% |
8 points | 120% |
•The R&D pipeline criterion, accounting for 10% of the award, was introduced in 2024 to reflect the importance of Sanofi's
commitment to developing a robust R&D pipeline. The performance criterion is based on the attainment levels of two equally-
weighted performance indicators measured over a three-year period.
1.Clinical Trial Readouts (CTRs) - the number of clinical trial results based on forecast pipeline deliveries
At the end of the period, the CTR attainment level will be calculated on the basis of the number of CTRs achieved in the period as
follows:
Number of Clinical Trial Readouts (CTRs) | CTR Attainment Level |
CTR < 15 | 0% |
CTR = 15 | 50% |
CTR > 15, but < 30 | (50+ [CTR – 15] x (10/3))% |
CTR = 30 | 100% |
CTR >30 but <35 | (100+ [CTR– 30] x 4)% |
CTR ≥ 35 | 120% |
2.Regulatory Approvals (RAs) – the number of regulatory approvals obtained for new molecular entities (NMEs), new vaccine
entities (NVEs) or line extensions in key markets, relative to forecast pipeline deliveries
At the end of the period, the “Regulatory Approval” (RA) attainment level will be calculated on the basis of the number of RAs
obtained in the period as follows:
Number of regulatory approvals (RA) of NMEs, NVEs and line extensions in key markets | RA attainment level |
RA < 15 | 0% |
RA = 15 | 50% |
RA > 15 but < 30 | (50+ [RA – 15] x (10/3))% |
RDA = 60 | 100% |
RA >30 but < 35 | (100+ [RA – 23 x 4)% |
RA ≥ 35 | 120% |
The R&D Allocation Rate will be determined as the weighted average of the CTR attainment level and the RA attainment level.
Other terms and conditions
Paul Hudson is under an obligation to retain, until he ceases to hold office, a number of Sanofi shares equivalent to 50% of the
capital gain as calculated on the vesting date, net of associated taxes and contributions. At present, the number of shares that
the Chief Executive Officer is obliged to retain under past compensation plans that have now vested is 33,440. As of January 28,
2026, those shares were valued at €2,634,738, representing around 165% of Paul Hudson's annual fixed compensation.
In compliance with the AFEP-MEDEF Code and our Board Charter, Paul Hudson has undertaken to refrain from entering into
speculative or hedging transactions, and so far as Sanofi is aware no hedging instruments have been contracted.
SANOFI FORM 20-F 2025 | 133 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Historical allocation rates
In the interests of transparency, we disclose below attainment levels and allocation rates for the most recent performance-linked
equity-based compensation plans awarded to our Chief Executive Officer.
Attainment level | Allocation rate | ||||
BNI | FCF | TSR | CSR | ||
April 30, 2021 plans | 2021-2023: 103.58% | 2021-2023: 110.31% | 2021-2023: 51.77% | 2021-2023: 95.23% i.e. 71,423 performance shares | |
May 3, 2022 plans | 2022-2024: 102.56% | 2022-2024: 110.25% | 2022-2024: 0% | 2022-2024: 84.36% i.e. 69,597 performance shares | |
May 25, 2023 plans* | 2023-2025: 101.03% | 2023-2025: 1110.01% | 2023-2025: 150% | 2023-2025: 120% | 2023-2025: 100% i.e. 82,500 performance shares |
Performance shares awarded to Paul Hudson in 2025
(table No. 6 of the AFEP-MEDEF Code)
Source | Plan date | Valuation of performance shares (€) | Number of performance shares awarded during the period | Vesting date | Availability date(a) | Performance conditions |
Sanofi | April 30, 2025 | 6,759,000 | 90,000 | May 1, 2028 | May 2, 2028 | Yes |
(a)Under the terms of our Board Charter, Paul Hudson is required to retain a quantity of shares corresponding to 50% of the capital gain arising on the
vesting of the shares, net of the associated taxes and social contributions.
Each performance share awarded on April 30, 2025 was valued at €75.10, valuing the total benefit at €6,759,000.
The General Meeting of April 30, 2024 restricted the number of performance shares that can be awarded to executive officers
to 5% of the overall limit (itself set at 1.5% of the share capital). The number of shares awarded to Paul Hudson in 2025
represents 0.43% of the total limit approved by that Meeting and 0.006% of our share capital at the date of grant.
Performance shares awarded to Paul Hudson which became available in 2025
(table No. 7 of the AFEP-MEDEF Code)
Paul Hudson was awarded 82,500 performance shares on May 3, 2022. The Board of Directors meeting of February 12, 2025
noted the level of attainment of the performance conditions applicable to this plan (84.36%), and 69,597 shares vested in Paul
Hudson on May 5, 2025.
Source | Plan date | Number of performance shares vesting during the period |
Sanofi | May 3, 2022 | 69,597 |
Because awards of stock options to our Chief Executive Officer are not permitted under our compensation policy, tables No. 4
and No. 5 of the AFEP-MEDEF Code are not applicable.
Pension rights
Paul Hudson is entitled to benefits under the top-up defined-contribution pension plan introduced within Sanofi on
January 1, 2020. Under the terms of the plan, the Chief Executive Officer receives (subject to attainment of a performance
condition) an annual contribution of up to 25% of his reference compensation (annual fixed and variable compensation).
The performance condition for the vesting of pension rights is linked to the attainment of the performance criteria for 2025
variable compensation. The Board of Directors, at its meeting of February 11, 2026, ascertained whether that performance
condition had been met, noting that the global attainment level for the variable portion of Paul Hudson’s compensation for the
2025 financial year was 109%.
The annual gross contribution is paid as follows:
•50% as a gross insurance premium to the fund manager – the amount due to the fund manager with respect to 2025 is
€527,000; and
•50% to Paul Hudson, to indemnify him for the social security and tax charges for which he will become immediately liable. The
amount due to Paul Hudson in respect of 2025 was set by the Board of Directors at its meeting of February 11, 2026
at €527,000.
Payment of those amounts is contingent on approval of the Chief Executive Officer’s compensation package by the shareholders
in an Ordinary General Meeting, on the terms stipulated in Article L. 22-10-34 II of the French Commercial Code.
(1)In 2025, it was agreed that for the purpose of calculating the attainment of quantitative criteria, the performance figures would be adjusted to eliminate
impacts related to (i) the acquisition of Blueprint and (ii) share buybacks; those adjustments negatively affected Sales Growth and Business EPS.
134 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Social welfare and health insurance
Paul Hudson is subject to, benefits from and contributes to the same health cover, and death and disability plans, as are
applicable to other employees of Sanofi based in France. He also benefits from an unemployment insurance scheme.
Benefits in kind
The benefits in kind received by Paul Hudson in 2025 were valued at €13,497, and correspond to a company car with a driver.
Compensation and benefits for other Executive Committee members
Compensation
The compensation of Executive Committee members other than the Chief Executive Officer is reviewed by the Compensation
Committee, taking into consideration the practices of leading global pharmaceutical companies.
In addition to fixed compensation, they receive variable compensation. Their target variable compensation depends on their
position, and can represent up to 100% of their fixed compensation. The target amount of individual variable compensation is
determined in line with market practice. It rewards the joint contribution of all Executive Committee members to Sanofi’s
performance.
For 2025, the variable component consisted of three elements:
•attainment of quantitative objectives (accounting for 60%) measured at consolidated level: Sales growth 20%, Business EPS
20%, research and development outcomes 10%, and FCF 10%;
•attainment of (CSR) objectives measured at consolidated level (accounting for 10%); and
•attainment of individual quantitative and qualitative objectives (accounting for 30%).
The indicators(1) used are intended to measure Sanofi’s annual performance objectives; individual objectives; the attainment of
human capital objectives (such as gender representation in senior executive roles and transformation of the corporate culture to
align with Sanofi's strategy; and an objective relating to the reduction in Sanofi's carbon footprint.
In addition, Executive Committee members may be awarded performance shares.
For 2025, the total gross compensation paid and accrued in respect of members of the Executive Committee (excluding the
Chief Executive Officer) was €20 million, of which €9 million was fixed compensation.
A total of 283,311 performance shares were awarded in 2025 to members of the Executive Committee (excluding the award to the
Chief Executive Officer). No stock options were awarded to members of the Executive Committee or the Chief Executive Officer
in 2025.
In compliance with the AFEP-MEDEF Code, all awards are contingent upon five internal criteria: Business EPS, FCF, a CSR
criterion, and a criterion linked to the R&D pipeline. An external criterion based on TSR is also applied. Those criteria were
selected because they align equity-based compensation with the strategy adopted by Sanofi. The Board believes that the
performance conditions applied are good indicators of shareholder value creation in terms of the quality of investment decisions
and the commitment to deliver exacting financial results in a difficult economic environment.
The arrangements relating to these awards are as follows:
•The performance criterion based on Business EPS accounts for 35% of the award. Business EPS represents Sanofi's “business
net income” divided by the number of Sanofi shares; this criterion corresponds to the average actual-to-budget ratio of
Business EPS attained over the entire period. Budgeted business net income is derived from the budget as approved by the
Board of Directors at the beginning of each financial year. The Business EPS objective may not be lower than the bottom end
of the full-year guidance range publicly announced by Sanofi at the beginning of each year. If the ratio is less than 95% of the
objective, the corresponding performance shares are forfeited.
Business EPS actual-to-budget attainment level (B) | Business EPS allocation rate |
If B is < 95% | 0% |
If B = 95% | 50% |
If B is > 95% but < 98% | (50 + [(B –95) x 16])% |
If B is ≥ 98% but ≤ 105% | B% |
If B is > 105% but < 110% | (105 + [(B –105) x 3])% |
If B is ≥ 110% | 120% |
(2)Amgen Inc., AstraZeneca plc, Bayer AG, Bristol-Myers-Squibb Inc., Eli Lilly and Company Inc., GlaxoSmithKline plc, Johnson & Johnson Inc., Merck & Co.
Inc., Novartis AG, Novo Nordisk A/S, Pfizer Inc., and Roche Holding AG. The Board of Directors may review the composition of the panel during the
measurement period in exceptional circumstances (dissolution or merger of a panel company).
(3)Historical values are adjusted for spin-offs, stock splits/reverse stock splits, scrip dividends/bonus issues, rights issues, etc.
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ITEM 6. Directors, Senior Management and Employees |
•The FCF criterion accounts for 25% of the award. It represents the average actual-to-budget ratio of FCF attained over the
entire period. The award is based on a target FCF, below which some or all performance shares are forfeited.
FCF actual-to-budget attainment level (F) | FCF allocation rate |
If F is ≤ 70% | 0% |
If F is > 70% but < 80% | [(F – 70) x 5]% |
If F = 80% | 50% |
If F is > 80% but < 100% | (50 + [(F – 80) x 2.5])% |
If F = 100% | 100% |
If F is > 100% but < 120% | F% |
If F is > 120% | 120% |
•The criterion based on TSR Rank Improvement accounts for 20% of the award.
•This performance criterion compares Sanofi's three-year TSR performance with the median TSR of comparable companies
included in a peer panel of 12 pharmaceutical companies(2) over the same period. Sanofi's TSR corresponds to the performance
of the Sanofi share price(3) uplifted by dividends per share during the measurement periods, without reinvestment.
TSR calculation
The TSR of each company is calculated using the following formula:
(Average 2027 share price – Average 2024 share price + Dividends per share 2025-2027) / Average 2024 share price
Where:
–"Average 2027 share price" is the average of the opening share prices from January 1, 2027 through December 31, 2027;
–"Average 2024 share price" is the average of the opening share prices from January 1, 2024 through December 31, 2024;
and
–"Dividends per share 2025-2027" is the sum total of dividends paid out on the shares of each company from January 1,
2025 through December 31, 2027, without reinvestment.
•The criterion based on CSR accounts for 10% of the award, and is linked to attainment of (i) annual objectives over a
three-year period and (ii) a "stretch" objective, linked to the following pillars:
1.Affordable Access: providing essential medicines to non-communicable disease patients through Sanofi Global Health; and
2.Planet Care: Carbon Emissions Reduction, scopes 1 & 2 (reduction in emissions vs 2019).
Attainment of each annual CSR objective will generate one performance point; a maximum of three points (plus one bonus
point for the "stretch" objective) may be obtained for each pillar. For each criterion, attainment of the 2026 objectives will
generate three points, even if the annual objectives are not attained.
•The R&D pipeline criterion, accounting for 10% of the award, corresponds to the attainment levels of two equally-weighted
performance indicators measured over a three-year period:
1.CTRs - the number of clinical trial results based on forecast pipeline deliveries;
2.Regulatory Approvals – the number of regulatory approvals obtained for NMEs, NVEs or line extensions in key markets,
relative to forecast pipeline deliveries.
•The number of performance shares vesting depends on the overall allocation rate, which for each period is the weighted
average of the Business EPS allocation rate (35%), the FCF allocation rate (25%), the TSR allocation rate for the period (20%),
the CSR allocation rate (10%), and the R&D allocation rate (10%).
•In order to align equity-based compensation with medium-term performance, performance is measured over three financial years.
•Vesting is subject to a non-compete clause.
•The entire award is forfeited in the event of resignation, or dismissal for gross or serious misconduct;
•In the event of (i) individual dismissal other than for gross or serious misconduct, (ii) retirement before the age of 60, (iii) the
beneficiary’s employer ceasing to be part of the Sanofi group or (iv) termination of employment contract under the terms of a
collective separation plan initiated by the employer in accordance with locally applicable legislation or measures approved by
local authorities, the overall allocation percentage is apportioned on a pro rata time basis to reflect the amount of time the
person remained with the Sanofi group during the vesting period.
•If any of the following events occur, full rights to the award are retained: (i) retirement on or after reaching the statutory
retirement age, or after the age of 60 under any circumstances;; (ii) disability classified in the second or third categories as
stipulated in Article L. 314-4 of the French Social Security Code; or (iii) death of the beneficiary.
136 | SANOFI FORM 20-F 2025 |
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ITEM 6. Directors, Senior Management and Employees |
Pension arrangements
The total amount accrued as of December 31, 2025 in respect of corporate pension plans for persons who have held an executive
position during 2025 was €10 million. That amount includes an expense of €1 million recognized in profit or loss during 2025.
Pay ratio between compensation of executive officers and average/median compensation of Sanofi
employees – changes in compensation of executive officers and employees relative to the performance
of Sanofi
This information is disclosed in accordance with Article L. 22-10-9 6° of the French Commercial Code, further to the enactment
of the “Pacte” law.
Sanofi has referred to the guidance on compensation multiples issued by AFEP (version issued February 2021) in establishing the
calculation methods used for the ratios presented.
Explanations of calculation methods and of year-on-year changes in the executive pay ratio:
•the scope includes Sanofi SA (the parent company) and all of its direct and indirect subsidiaries located in France, and hence
covers more than 80% of total payroll of permanent employees in France. Opella group employees are no longer included
within the scope from 2025. No separate ratios are published for Sanofi SA (the parent company), as the low headcount at
Sanofi SA means that such ratios would not be representative of our total headcount in France;
•the employee compensation used in the calculation is the full time equivalent (FTE) compensation of permanent employees
with at least two financial years of uninterrupted employment;
•direct compensation includes fixed compensation awarded during the reference year, and variable compensation related to
the previous year and paid during the reference year. All compensation amounts are gross amounts;
•in order to maintain consistency, we have excluded from the numerator (i) compensation items not included in the denominator
and (ii) non-recurring compensation items. This applies in particular to accommodation expenses related to the relocation to
France of the Chief Executive Officer (Paul Hudson) in 2020, and to expenses related to unemployment insurance;
•long term variable compensation: performance shares and stock options awarded during each reference year are valued at
the date of grant in accordance with International Financial Reporting Standards. The valuation of performance shares that
include the Total Shareholder Return (TSR) performance condition incorporates market conditions where applicable. Awards
are subject to a continuing employment condition (three years minimum) and to performance conditions. Consequently, the
valuation at the date of grant is not necessarily indicative of the value of stock options and performance shares at the end of
the vesting period, especially if the performance conditions are not met;
•since Olivier Brandicourt (our previous Chief Executive Officer) received the same number of stock options and performance
shares each year from 2016 to 2019, fluctuations in the Sanofi share price had a significant impact on the pay ratio during this
period;
•2018 and 2019 figures have been restated for comparative purposes, to (i) exclude Sanofi’s equity-accounted share of
Regeneron’s net profits (see Note D.1. to our consolidated financial statements included at Item 18. of this annual report) and
(ii) include the effects of IFRS 16;
•regular benchmarking reviews are conducted to ensure that the level of compensation awarded to our employees and CEO is
competitive and consistent with pharmaceutical industry levels.
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ITEM 6. Directors, Senior Management and Employees |
Comparison of compensation of Sanofi executive officers with employee compensation* (parent company and all direct
and indirect subsidiaries located in France), and year-on-year change in compensation of corporate officers and employees
with reference to the company’s performance
Chief Executive Officer | 2021 vs 2020 | 2022 vs 2021 | 2023 vs 2022 | 2024 vs 2023 | 2025 vs 2024 |
Change in compensation (%) | -1.0% | 20.5% | -1.5% | 1.7% | 11.4% |
Ratio versus average employee compensation | 111.44 | 124.55 | 124.49 | 124.42 | 123.25 |
Year-on-year change in ratio (%) | 0.7% | 11.8% | -0.1% | -0.1% | -0.9% |
Ratio to median employee compensation | 142.11 | 159.17 | 159.97 | 158.01 | 159.50 |
Year-on-year change in ratio (%) | -0.5% | 12.0% | 0.5% | -1.2% | 0.9% |
Chairman of the Board (a) | 2021 vs 2020 | 2022 vs 2021 | 2023 vs 2022 | 2024 vs 2023 | 2025 vs 2024 |
Change in compensation (%) | —% | —% | 5.7% | 3.7% | —% |
Ratio versus average employee compensation | 10.15 | 9.41 | 10.09 | 10.28 | 9.14 |
Year-on-year change in ratio (%) | 1.7% | -7.3% | 7.2% | 1.9% | -11.1% |
Ratio versus median employee compensation | 12.94 | 12.03 | 12.97 | 13.06 | 11.83 |
Year-on-year change in ratio (%) | 0.5% | -7.1% | 7.8% | 0.7% | -9.4% |
Employees | 2021 vs 2020 | 2022 vs 2021 | 2023 vs 2022 | 2024 vs 2023 | 2025 vs 2024 |
Change in compensation (%) | -1.7% | 7.8% | -1.4% | 1.8% | 12.5% |
Company Performance | |||||
Financial criterion | BNI | BNI | BNI | BNI | BNI |
Year-on-year change (%) | 11.8% | 25.9% | -1.8% | 0.2% | -1.4% |
*Table based on the model table recommended in the AFEP guidance on compensation multiples (February 2021).
(a)Frédéric Oudéa (since May 25, 2023). Serge Weinberg’s term of office expired on May 25, 2023.
Based on full-time equivalent permanent employees of all Sanofi legal entities worldwide with at least two years of uninterrupted
employment, the ratios for 2025 were as follows:
Chief Executive Officer | 2021 vs 2020 | 2022 vs 2021 | 2023 vs 2022 | 2024 vs 2023 | 2025 vs 2024 |
Ratio versus average employee compensation | 130.00 | 136.90 | 125.60 | 117.90 | 122.30 |
Year-on-year change in ratio (%) | 5.0% | 5.3% | -8.3% | -6.1% | 3.7% |
Ratio versus median employee compensation | 190.50 | 200.50 | 182.90 | 166.30 | 167.20 |
Year-on-year change in ratio (%) | 1.3% | 5.2% | -8.8% | -9.1% | 0.5% |
Chairman of the Board (a) | 2021 vs 2020 | 2022 vs 2021 | 2023 vs 2022 | 2024 vs 2023 | 2025 vs 2024 |
Ratio versus average employee compensation | 11.80 | 10.30 | 10.20 | 9.60 | 9.10 |
Year-on-year change in ratio (%) | 6.3% | -12.7% | -1.0% | -5.9% | -5.2% |
Ratio versus median employee compensation | 17.30 | 15.10 | 14.80 | 13.50 | 12.40 |
Year-on-year change in ratio (%) | 2.4% | -12.7% | -2.0% | -8.8% | -8.1% |
(a)Frédéric Oudéa (since May 25, 2023). Serge Weinberg’s term of office expired on May 25, 2023.
These ratios were calculated on the basis of annualized basic compensation, variable compensation in respect of the previous
year, and performance shares awarded during 2025, applying 2025 average exchange rates.
138 | SANOFI FORM 20-F 2025 |
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ITEM 6. Directors, Senior Management and Employees |
C. Board Practices
Application of the AFEP-MEDEF Code
The corporate governance code applied by Sanofi is the December 2022 version of the AFEP-MEDEF Code which is available at
https://hcge.fr/le-code-afep-medef/.
Our Board Charter requires at least one-half of our directors to be independent; contains a section on the ethical rules applicable
to our directors; sets out the remit and operating procedures of the Board; defines the roles and powers of our Chairman and our
Chief Executive Officer; and describes the composition, remit and operating procedures of the Board committees, in accordance
with the recommendations of the AFEP-MEDEF Code. Collectively, our Articles of Association and our Board Charter establish
the framework within which Sanofi implements its principles of corporate governance
Our Board practices comply with the AFEP-MEDEF Code recommendations, with certain exceptions, and with the report of the
Autorité de marchés financiers on Audit Committees, issued on July 22, 2010.
Activities of the Board of Directors in 2025
During 2025, the Board of Directors met fourteen times (including strategy seminars), with an overall attendance rate among
Board members of 99%.
The following persons attended meetings of the Board of Directors:
•the directors;
•the Secretary to the Board;
•frequently: members of the Executive Committee; and
•occasionally: the statutory auditors, managers of our global support functions, and other company employees.
The agenda for each meeting of the Board is prepared by the Secretary after consultation with the Chairman, taking account of
the agendas for the meetings of the specialist Committees and the suggestions of the directors.
Approximately one week prior to each meeting of the Board of Directors, the directors each receive a file containing the agenda,
the minutes of the previous meeting, and documentation relating to the agenda.
The minutes of each meeting are expressly approved at the next meeting of the Board of Directors.
In compliance with our Board Charter, certain issues are examined in advance by the various Committees according to their areas
of competence, to enable them to make a recommendation; those issues are then submitted for a decision by the Board of
Directors.
Since 2016, acting on a recommendation from the Appointments, Governance and CSR Committee, each year the Board has held
at least two executive sessions, i.e. meetings held without the Chief Executive Officer present. If the Chairman of the Board so
decides, such sessions may also be held without the directors representing employees (or any other Sanofi employee) being
present. The primary purpose of such sessions is to evaluate the way the Board and its Committees operate, discuss the
performance of the Chief Executive Officer, and debate succession planning. Three executive sessions were held in 2025: two
one-hour sessions in January and February, and a 20-minute session in April.
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ITEM 6. Directors, Senior Management and Employees |
In 2025, the main activities of the Board of Directors related to the following issues:
FINANCIAL STATEMENTS AND FINANCIAL MANAGEMENT | |
l | Review of the individual company and consolidated financial statements for the 2024 financial year and for the first half of 2025, review of the consolidated financial statements for the first three quarters of 2025, and review of draft press releases and presentations to analysts relating to the publication of those financial statements. |
l | Projected 2025 accounting close and presentation of 2026 budget. |
l | Review of forward-looking management documents. |
l | Proposed dividend for the 2024 financial year. |
l | Renewal of share repurchase program. |
l | Delegation to the Chief Executive Officer of the power to issue bonds. |
l | Authorizations in respect of guarantees, endorsements and sureties, and report on the use made of the authorizations granted in 2024. |
« | Purchase of a block of shares from L'Oréal for €3 billion. |
« | Reduction of the share capital by cancellation of treasury shares, and amending the articles of association accordingly. |
OPERATIONS, STRATEGY AND RISK MANAGEMENT | |
l | Review of the minutes of the meetings of the Strategy Committee and Scientific Committee. |
l | Update on risks, and review of risk management activity report and 2025 risk profile analysis. |
l | Review of acquisition projects. |
l | Update on business development projects. |
« | Review of the pipeline. |
« | Updates on the Opella separation. |
« | Update on vaccines. |
« | Update on China. |
« | Update on litigation (including Zantac). |
« | Digitalization and digital strategy. |
« | Update on the potential impact of US tariffs. |
APPOINTMENTS AND GOVERNANCE | |
l | Review of director independence. |
l | Review of management report, corporate governance report, and statutory auditors' reports. |
l | Adoption of draft resolutions, the Board report on the resolutions, and special reports on awards of stock options and performance shares. |
l | Annual evaluation of the work of the Board and its committees. |
l | Review of previously-approved related-party agreements. |
l | Updates on the Action 2025 employee share ownership plan. |
« | Composition of the Board and its committees. •appointment of Clotilde Delbos as Chair of the Compensation Committee; •proposal to renew the terms of office of Carole Ferrand, Barbara Lavernos, Emile Voest and Antoine Yver as directors, and ratification of the co- opting of Jean-Paul Kress at the 2025 Annual General Meeting; •succession plan for the Chief Executive Officer. |
COMPENSATION | |
l | Determination of the compensation of corporate officers: •review of the components of compensation paid in 2024; •determination of compensation policies, including changes to the compensation policy of the Chief Executive Officer. |
l | Allocation of directors' compensation for 2024, and principles for the 2025 allocation. |
l | Review of fixed and variable Executive Committee compensation for 2024 and 2025. |
l | Adoption of performance share plans for 2025, sign-off on attainment of performance conditions for prior equity-based compensation plans. |
CORPORATE SOCIAL RESPONSIBILITY | |
l | Monitoring of objectives for gender representation on executive bodies, and more generally of Sanofi's diversity policy (in accordance with applicable regulations). |
l | Monitoring of Sanofi's equal pay and equal opportunity policy. |
« | Ethics and corporate culture update. |
« | Implementation of the European Corporate Sustainability Reporting Directive (CSRD), and feedback on the CSRD. |
« | Feedback on compliance investigations conducted in 2023 and 2024. |
« | Update on the thoughtful risk-taking program (internal program to transform Sanofi's decision-making culture). |
l Annual items | « Non-recurring items |
140 | SANOFI FORM 20-F 2025 |
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ITEM 6. Directors, Senior Management and Employees |
In addition, two strategy seminars were held, in April and October 2025, in which members of the Executive Committee took part.
The seminar gave directors an opportunity to address issues including:
•strategic aspects of acquisitions: future prospects and feedback;
•impacts and changes driven by artificial intelligence across the value chain;
•global pricing strategy for medicines and vaccines;
•governance of R&D activities;
•update on the product portfolio;
•medium/long-term financial trajectory, including forecasts arising from "Strat Days" (two-day Executive Committee meetings
focused on long-term strategic orientations);
•review of commercial performances in France;
•capital allocation strategy in terms of commercial development and mergers/acquisitions;
•transformation of the R&D function: governance, human resources and key performance indicators;
•status report on Manufacturing & Supply, with specific focus on operations in France; and
•monitoring of Sanofi's ranking and reputation.
Finally, a site visit to the facility at Vitry-sur-Seine in France gave Board members an opportunity to see how Sanofi's R&D and
Manufacturing & Supply operations work in practice.
Remit and Operation of Board Committees
Our Board of Directors is assisted in its deliberations and decisions by five specialist Committees (for a description of the remit of
each Committee, refer to our Board Charter, provided as Exhibit 1.2 to this annual report). Chairs and members of these
Committees are chosen by the Board from among its members, based on their experience.
The Committees are responsible for the preparation of certain items on the agenda of the Board of Directors. Decisions of the
Committees are adopted by a simple majority with the Chair of the Committee having a casting vote. Minutes are prepared, and
approved by the Committee members.
The Chair of each Committee reports to the Board on the work of that Committee, so that the Board is fully informed whenever it
takes a decision.
Audit Committee
Composition of the Committee in 2025
Audit Committee | ||
Composition as of January 1, 2025 | Composition as of December 31, 2025 | |
Chair | Carole Ferrand (independent director) | Carole Ferrand (independent director) |
Members | Christophe Babule (a) Fabienne Lecorvaisier (independent director) (b) Clotilde Delbos (independent director) Anne-Françoise Nesmes (independent director) | Christophe Babule (a) Clotilde Delbos (independent director) Anne-Françoise Nesmes (independent director) |
Proportion of independent directors: 80% (4/5) | Proportion of independent directors: 75% (3/4) | |
(a)This table only refers to independence as defined under the AFEP-MEDEF Code. However, Christophe Babule is independent for the purposes of the
NASDAQ Listing Rules and Rule 10A-3 under the Exchange Act.
(b)Fabienne Lecorvaisier left the Board on April 30, 2025.
All members of the Audit Committee have financial or accounting expertise as a consequence of their training and professional
experience, and all are deemed to be financial experts as defined by the Sarbanes-Oxley Act and by Article L. 823-19 of the
French Commercial Code. See “Item 16A. Audit Committee Financial Expert”.
Remit of the Committee
The remit of the Committee is described in our Board Charter, provided as Exhibit 1.2 to this annual report.
Since December 2023, our Audit Committee has been tasked with reviewing the process for the preparation and certification of
sustainability disclosures. In fulfilling that role, the Audit Committee works in conjunction with the Appointments, Governance and
CSR Committee. Collectively, the two committees determined the material sustainability issues facing Sanofi.
SANOFI FORM 20-F 2025 | 141 |
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ITEM 6. Directors, Senior Management and Employees |
Operation of the Committee
In addition to the statutory auditors, the principal financial officers, the Senior Vice President Group Internal Audit and other
members of the senior management team attend meetings of the Audit Committee.
The statutory auditors attend all meetings of the Audit Committee; they presented their opinions on the annual and half-year
financial statements at the Committee meetings of January 28 and July 29, 2025, respectively. The Committee meets regularly
with the statutory auditors without management present.
The Chair of the Committee also meets regularly with certain members of management, in particular the heads of Internal Audit,
Risk Management and Ethics/Compliance.
For information about Audit Committee oversight of internal control and risk management relating to the processing of
accounting and financial information, refer to “Item 15. Controls and Procedures.”
A joint session is held annually with the Appointments, Governance and CSR Committee on the implementation of the CSRD.
Work of the Committee in 2025
The work of the Committee in 2025 is summarized below:
FINANCIAL POSITION | |
l | Preliminary review of the individual company and consolidated financial statements for the 2024 financial year, review of the individual company and consolidated financial statements for the first half of 2025, review of the consolidated financial statements for the first three quarters of 2025, and review of draft press releases. |
l | Financial position of Sanofi, indebtedness and liquidity, off balance sheet commitments. |
« | Review of financial impacts identified in the interim analysis of data from the study on the E.Coli vaccine candidate. |
INTERNAL AUDIT, INTERNAL CONTROL AND RISK MANAGEMENT | |
l | Review of the work of the Internal Control function and evaluation of that work for 2024 as certified by the statutory auditors pursuant to Section 404 of the Sarbanes-Oxley Act, and examination of the 2024 annual report on Form 20-F. |
l | Principal risks (risk management and risk profiles) including CSR risks; Risk Committee report for 2025; tracking of whistleblowing and material compliance investigations; review of emerging risks, including geopolitical and macroeconomic risks; review of tax risks and deferred tax assets; review of material litigation. |
l | Conclusions of Sanofi senior management on internal control procedures and review of the 2024 Management Report, in particular the description of risk factors in the Universal Registration Document and annual report on Form 20-F. |
l | Monitoring of application of the charter on related-party agreements. |
l | Internal audit report for 2025 and audit program for 2026. |
l | Reporting on guarantees, endorsements and sureties. |
l | Cybersecurity. |
« | Quality control review of insurance cover for directors' and executive officers' liability. |
« | Update on inventory levels |
« | Update on real estate costs |
STRATEGY AND COMPENSATION | |
l | Presentation of 2026 budget. |
l | Review of attainment of performance conditions for 2022 equity-based compensation plans. |
« | Update on product quality, in particular compliance at in-house production facilities and by Contract Manufacturing Organizations (CMOs). |
« | Update on supplier dependency policy. |
COMPLIANCE, BUSINESS ETHICS AND CSR | |
l | Review of European Green Taxonomy indicators included in the Universal Registration Document. |
l | Progress report on CSRD implementation. |
l | Joint session with Appointments, Governance and CSR Committee on CSRD implementation. |
« | Preliminary Impact Assessment of IFRS 18 (Presentation and Disclosures in Financial Statements) |
« | Update on health and safety in the workplace. |
« | Update on data ethics and data protection compliance. |
« | Update on fraud and internal investigations. |
RELATIONS WITH STATUTORY AUDITORS | |
l | Audit engagements and fees. |
l | Review and budget for non-audit services (audit-related services, tax, and other). |
l | Review of 2025 statutory audit plan, including sustainability reporting |
« | Initial planning for the forthcoming external audit tendering process. |
l Annual items | « Non-recurring items |
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ITEM 6. Directors, Senior Management and Employees |
Attendance rates in 2025
The Audit Committee met eight times in 2025, including meetings immediately prior to the Board meetings that approved the
financial statements. Committee members had an attendance rate of 94%.
Appointments, Governance and CSR Committee
Composition of the Committee in 2025
Appointments, Governance and CSR Committee | ||
Composition as of January 1, 2025 | Composition as of December 31, 2025 (unchanged) | |
Chair | Patrick Kron (independent director) | Patrick Kron (independent director) |
Members | Lise Kingo (independent director) Barbara Lavernos Frédéric Oudéa (independent director) | Lise Kingo (independent director) Barbara Lavernos Frédéric Oudéa (independent director) |
Proportion of independent directors: 75% (3/4) | Proportion of independent directors: 75% (3/4) | |
The Chief Executive Officer is involved in the work of the Committee.
Remit of the Committee
The remit of the Committee is described in our Board Charter, provided as Exhibit 1.2 to this annual report.
The remit to review the process for the preparation and certification of sustainability disclosures has been allocated to our Audit
Committee (see above). The Appointments, Governance and CSR Committee plays a role in this work through joint meetings.
Work of the Committee in 2025
The work of the Appointments, Governance and CSR Committee during 2025 covered the following issues:
APPOINTMENTS | |
l | Succession planning for the Chairman, Chief Executive Officer and Executive Committee. |
l | Changes to the composition of the Board and its committees, and of the Executive Committee. |
l | Review of expiring terms of office, and appointment of new Board members. |
« | Update on directors representing employees (reappointment and nomination by the trade union with the majority of votes in France). |
« | Succession plan for Patrick Kron. |
« | Succession plan for the Chief Executive Officer. |
GOVERNANCE | |
l | Update on annual evaluation of the Board and its committees. |
l | Review of director independence. |
l | Review of management report and corporate governance report in the 2024 Universal Registration Document and annual report on Form 20-F. |
l | Governance roadshows with key Sanofi investors, and analysis of the policies of proxy advisors. |
« | Update on decision-making processes available to the Board: written procedures and video conference. |
« | Update on governance around decision-making relating to business development and M&A. |
« | Approval of the updated matrix of Board competencies. |
« | 2025 director training program. |
CSR | |
l | Annual overview of CSR. |
l | Review of the CSR chapter in the 2024 Universal Registration Document. |
« | Update on the approach to human rights. |
« | Update on environmental issues. |
« | Joint meeting with Audit Committee: feedback on the implementation of the European CSRD |
« | Update on Foundation S. |
l Annual items | « Non-recurring items |
Attendance rates in 2025
The Committee met eight times in 2025, including a joint meeting with the Audit Committee, with an overall attendance rate of
100%.
SANOFI FORM 20-F 2025 | 143 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Compensation Committee
Composition of the Committee in 2025
Compensation Committee | ||
Composition as of January 1, 2025 | Composition as of December 31, 2025 | |
Chair | Patrick Kron (independent director) | Clotilde Delbos (independent director) (a) |
Members | Clotilde Delbos (independent director) Rachel Duan (independent director) Wolfgang Laux | Rachel Duan (independent director) Patrick Kron (independent director) (a) Wolfgang Laux |
Proportion of independent directors: 75% (3/4) | Proportion of independent directors: 75% (3/4) | |
(a)Clotilde Delbos was appointed as Chair of the Compensation Committee by a Board decision of April 30, 2025, replacing Patrick Kron, who remains a
member of the Committee.
Work of the Committee in 2025
The work of the Compensation Committee during 2025 covered the following issues:
COMPENSATION OF CORPORATE OFFICERS | |
l | Components of the compensation of corporate officers (Chief Executive Officer and Chairman of the Board of Directors). |
l | Review of performance conditions applicable to the compensation of the Chief Executive Officer, in particular CSR criteria. |
l | Allocation of directors’ compensation for 2024, and review of general principles of the compensation policy applicable to directors. |
l | Review of the disclosures about compensation contained in the corporate governance section of the 2024 Universal Registration Document and the annual report on Form 20-F, and of equal pay ratios. |
l | Review of the draft "say on pay" resolutions submitted to the Annual General Meeting of April 30, 2025. |
l | Governance roadshows with key Sanofi investors, and analysis of the policies of proxy advisors. |
« | Review of the structure of the Chief Executive Officer's compensation for 2025, and response to the shareholder vote on the Chief Executive Officer's compensation policy at the 2025 Annual General Meeting. |
« | Review of the rules for directors' compensation, and proposal for changes to the maximum overall allocation with effect from 2026. |
EQUITY-BASED COMPENSATION | |
l | Implementation of equity-based compensation plans awarded in prior years (sign-off on attainment of performance conditions for 2022 plans). |
EMPLOYEE SHARE OWNERSHIP | |
l | Status report and analysis of 2025 employee share ownership plan. |
l | Consideration of next employee share ownership plan, and implementation of Action 2026 plan. |
EXECUTIVE COMMITTEE COMPENSATION | |
l | Monitoring of fixed and variable compensation of Executive Committee members in 2024 and 2025. |
l Annual items | « Non-recurring items |
When the Committee discusses the compensation policy for members of senior management who are not corporate officers,
i.e. the members of the Executive Committee, the Committee invites the Chief Executive Officer to attend.
Attendance rates in 2025
The Committee met three times in 2025, with an overall attendance rate of 100%.
144 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Strategy Committee
Composition of the Committee in 2025
Strategy Committee | ||
Composition as of January 1, 2025 | Composition as of December 31, 2025 (unchanged) | |
Chair | Frédéric Oudéa (independent director) | Frédéric Oudéa (independent director) |
Members | Paul Hudson Jean-Paul Kress (independent director) Patrick Kron (independent director) Barbara Lavernos Antoine Yver (independent director) | Paul Hudson Jean-Paul Kress (independent director) Patrick Kron (independent director) Barbara Lavernos Antoine Yver (independent director) |
Proportion of independent directors: 66% (4/6) | Proportion of independent directors: 66% (4/6) | |
Work of the Committee in 2025
During 2025, the Committee's work included the following key issues:
l | Divestment/acquisition projects and business development priorities, some of which were discussed in joint session with the Scientific Committee. |
l | Update on the Play to Win strategy. |
« | Update on the product portfolio. |
« | Update on the General Medicines global business unit. |
« | Update from the CEO on the situation around US tariffs and their potential impact. |
« | Update on affairs in the United States (joint session with the Scientific Committee). |
l Annual items | « Non-recurring items |
Attendance rates in 2025
The Committee met six times in 2025, including three joint sessions with the Scientific Committee, with an overall attendance
rate of 97%.
Three joint sessions with the Scientific Committee took place, on May 14, October 21 and November 19, 2025, which dealt with
various divestment and acquisition opportunities, and affairs in the United States (including a presentation by the Chief Executive
Officer on vaccines, the "most favored nation" clause, and investment in the United States).
Scientific Committee
Composition of the Committee in 2025
Scientific Committee | ||
Composition as of January 1, 2025 | Composition as of December 31, 2025 (unchangesd) | |
Chair | Antoine Yver (independent director) | Antoine Yver (independent director) |
Members | Jean-Paul Kress (independent director) Frédéric Oudéa (independent director) John Sundy (independent director) Emile Voest (independent director) | Jean-Paul Kress (independent director) Frédéric Oudéa (independent director) John Sundy (independent director) Emile Voest (independent director) |
Proportion of independent directors: 100% (5/5) | Proportion of independent directors: 100% (5/5) | |
Work of the Committee in 2025
During 2025, the Committee’s work included the following key issues:
l | Review of product portfolio. |
l | Review of acquisition and alliance projects, some of which were discussed in joint session with the Strategy Committee. |
« | Update on the Genomic Medicine unit. |
« | Update on R&D outcomes in 2024. |
« | Review and sign-off of 2025 R&D objectives and key performance indicators. |
« | Update on innovation strategy in China. |
« | Update on neurodegenerative diseases and Alzheimer's. |
« | Review of clinical trial readouts. |
l Annual items | « Non-recurring items |
SANOFI FORM 20-F 2025 | 145 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Attendance rates in 2025
The Committee met fourteen times in 2025, including three joint sessions with the Strategy Committee, with an overall
attendance rate of 99%.
D. Employees
Number of Employees(a)
In 2025, Sanofi employed 74,846 people worldwide, 8,032 fewer than in 2024. The tables below give a breakdown of employees
by geographical area and function as of December 31, 2025, 2024 and 2023.
Employees by Geographical Area(a)
As of December 31, | ||||||
2025 | % | 2024 | % | 2023 | % | |
Europe | 36,794 | 49% | 41,193 | 50% | 42,115 | 49% |
United States | 12,707 | 17% | 12,898 | 16% | 13,418 | 16% |
Rest of the World | 25,345 | 34% | 28,787 | 35% | 30,555 | 35% |
Total | 74,846 | 100.0% | 82,878 | 100.0% | 86,088 | 100.0% |
Employees by Function(a)
As of December 31, | |||
2025 | 2024 | 2023 | |
Specialty Care | 8,291 | 10,039 | 11,784 |
Vaccines | 5,267 | 1,330 | N/A |
General Medicines | 8,929 | 7,459 | 9,694 |
Go To Market Capabilities | 1,640 | 5,103 | 5,444 |
Research and Development | 9,274 | 8,940 | 9,257 |
Manufacturing and Supply | 28,335 | 28,450 | 29,184 |
Corporate Functions | 12,789 | 11,186 | 10,078 |
Sub-total Biopharma | 74,525 | 72,507 | 75,441 |
Retained Business (Russia) | 321 | 10,371 | 10,647 |
TOTAL | 74,846 | 82,878 | 86,088 |
(a)Employees on garden leave and Executive Committee management level are excluded from the data.
Industrial Relations
In all countries where we operate, we seek to strike a balance between our economic interests and those of our employees, which
we regard as inseparable.
Our belief in a balanced workplace for our employees is based on the basic principles of our Social Charter, which outlines the
rights and duties of all Sanofi employees. The Social Charter addresses our key ambitions vis-à-vis our workforce: equal
opportunity for all people without discrimination, the right to health and safety, respect for privacy, the right to information and
professional training, social protection for employees and their families, freedom of association and the right to collective
bargaining, and respect for the principles contained in the Global Compact on labor relations and ILO conventions governing the
physical and emotional well-being and safety of children.
Our labor relations are based on respect and dialogue. In this spirit, management and employee representatives meet regularly to
exchange views, negotiate, sign agreements and ensure that agreements are being implemented.
Employee dialogue takes place in different ways from country to country, as dictated by specific local circumstances. Depending
on the circumstances, employee dialogue relating to information, consultation and negotiation processes may take place at
national, regional or company level. It may be organized on an interprofessional or sectorial basis, or both. Employee dialogue
may be informal or implemented through a specific formal body, or a combination of both methods. Whatever the situation,
Sanofi encourages employees to voice their opinions, help create a stimulating work environment and take part in decisions
aiming to improve the way we work. These efforts reflect one of the principles of the Social Charter, whereby improving working
conditions and the necessary adaptation to our business environment go hand-in-hand.
146 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Profit-sharing Schemes, Employee Savings Schemes and Employee Share Ownership
Profit-sharing schemes
All employees of our French companies belong to voluntary and statutory profit-sharing schemes.
Voluntary schemes
Voluntary schemes (intéressement des salariés) are collective schemes that are optional for the employer and contingent upon
performance. The aim is to give employees an interest in the growth of the business and improvements in its performance.
In June 2023, we entered into a new fixed-term statutory profit-sharing agreement for the 2023, 2024 and 2025 financial years,
which applies to all employees of our French companies. Under the agreement, Sanofi pays collective variable compensation
determined on the basis of the more favorable of (i) growth in consolidated net sales (at constant exchange rates and on a
constant structure basis) or (ii) the ratio of business operating income to net sales on a reported basis (BOI margin). For each of
those criteria, a matrix determines what percentage of total payroll is to be allocated to the scheme. An additional sum capped at
0.5% of total payroll may also be distributed, determined on the basis of two CSR-related performance conditions, each
weighted at 0.25%:
•a criterion reflecting progress in environmental matters (reduction in Sanofi greenhouse gas emissions worldwide); and
•a social responsibility criterion: the number of employees in France registered on Sanofi-referenced volunteering programs.
This overall allocation is reduced by the amount required by law to be transferred to a special profit-sharing reserve. The balance
is then distributed between the employees unless the transfer to the reserve equals or exceeds the maximum amount determined
under the specified criteria, in which case no profit share is paid to the employees.
No distribution was made under the voluntary scheme in 2025 in respect of 2024.
Statutory scheme
The statutory scheme (participation des salariés aux résultats de l’entreprise) is a French legal obligation for companies with
more than 50 employees that made a profit in the previous financial year.
The amount distributed by our French companies in 2025 in respect of the statutory scheme for the year ended
December 31, 2024 represented 8.29% of total payroll.
Distribution formula
In order to favor lower-paid employees, the voluntary and statutory profit-sharing agreements entered into since 2005 split the
benefit between those entitled as follows:
•60% prorated on the basis of time spent in the Company’s employment in the year; and
•40% prorated on the basis of gross annual salary received during the year, subject to a lower limit equal to the social security
ceiling and an upper limit of three times the social security ceiling.
Employee savings schemes and collective retirement savings plan
The employee savings arrangements operated by Sanofi are based on a collective savings scheme (Plan d’Épargne Groupe) and a
collective retirement savings scheme (Plan d’Épargne pour la Retraite Collectif). Those schemes reinvest the sums derived from
the statutory and voluntary profit-sharing schemes, plus voluntary contributions from employees.
In June 2025, 92% of the employees who benefited from the profit-sharing schemes opted to invest in the collective savings
scheme, and nearly 75.3% opted to invest in the collective retirement savings scheme.
Sanofi supplements the amount invested by employees in these schemes by making a top-up contribution.
In 2025, €160 million was invested in the collective savings scheme and €61.3 million in the collective retirement savings scheme,
through the voluntary and statutory schemes and through top-up contributions.
Employee share ownership
As of December 31, 2025, shares held under the collective savings scheme or in registered form by employees of Sanofi,
employees of related companies and former employees amounted to 2.93% of our share capital.
For more information about our most recent employee share ownership plan, refer to “Item 10. Additional Information — Changes
in Share Capital — Increases in Share Capital”.
SANOFI FORM 20-F 2025 | 147 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
E. Share Ownership
Senior Management
Members of the Executive Committee hold shares of our Company amounting in the aggregate to less than 1% of our share
capital.
Existing Option Plans as of December 31, 2025
In 2019, the Board of Directors reviewed Sanofi’s compensation policy and decided that stock options would no longer be
awarded from 2020 onwards. That decision was taken to standardize the terms of equity-based compensation awards within
Sanofi, and in response to feedback from some shareholders and proxy advisors who had concerns about stock options given
their dilutive effect and potential unintended consequences.
Share Purchase Option Plans
As of December 31, 2025 there were no stock purchase option plans outstanding.
Share Subscription Option Plans
Source | Date of shareholder authorization | Date of grant | Total number of options granted | to corporate officers(a) | to the 10 employees awarded the most options(b) | Start date of exercise period | Expiry date | Exercise price (€) | Number of shares subscribed as of 12/31/2025 | Number of options canceled as of 12/31/2025(c) | Number of options outstanding |
Sanofi | May 3, 2013 | Jun 24, 2015 | 12,500 | — | 12,500 | Jun 25, 2019 | Jun 24, 2025 | 89.38 | 2,250 | 10,250 | — |
Sanofi | May 3, 2013 | Jun 24, 2015 | 202,500 | — | 202,500 | Jun 25, 2019 | Jun 24, 2025 | 89.38 | 166,000 | 36,500 | — |
Sanofi | May 3, 2013 | Jun 24, 2015 | 220,000 | 220,000 | — | Jun 25, 2019 | Jun 24, 2025 | 89.38 | 178,464 | 41,536 | |
Sanofi | May 4, 2016 | May 4, 2016 | 17,750 | — | 17,750 | May 5, 2020 | May 4, 2026 | 75.90 | 4,650 | 9,750 | 3,350 |
Sanofi | May 4, 2016 | May 4, 2016 | 165,000 | — | 165,000 | May 5, 2020 | May 4, 2026 | 75.90 | 82,500 | 82,500 | |
Sanofi | May 4, 2016 | May 4, 2016 | 220,000 | 220,000 | — | May 5, 2020 | May 4, 2026 | 75.90 | 178,750 | 41,250 | — |
Sanofi | May 10, 2017 | May 10, 2017 | 158,040 | — | 157,140 | May 11, 2021 | May 10, 2027 | 88.97 | 34,184 | 44,276 | 79,580 |
Sanofi | May 10, 2017 | May 10, 2017 | 220,000 | 220,000 | — | May 11, 2021 | May 10, 2027 | 88.97 | 42,570 | 177,430 | |
Sanofi | May 2, 2018 | May 2, 2018 | 220,000 | 220,000 | — | May 3, 2022 | May 3, 2028 | 65.84 | 51,216 | 168,784 | |
Sanofi | Apr 30, 2019 | Apr 30, 2019 | 220,000 | 220,000 | — | May 1, 2023 | Apr 30, 2029 | 76.71 | 6,600 | 213,400 |
(a)Comprises the Chief Executive Officer, and any Deputy Chief Executive Officers or members of the Management Board in office at the date of grant.
(b)In office at the date of grant.
(c)Includes 227,448 options cancelled due to partial non-fulfillment of performance conditions.
No stock options were exercised in 2025 by individuals who were Executive Committee members as of December 31, 2025.
As of December 31, 2025, a total of 725,044 stock subscription options remained outstanding. As of the same date,
725,044 options were immediately exercisable.
Existing Performance Share Plans as of December 31, 2025
The Board of Directors awards shares to certain employees in order to give them a direct stake in our future and performances
via trends in the share price, as a partial substitute for the granting of stock options.
Shares are awarded to employees by the Board of Directors on the basis of a list submitted to the Compensation Committee. The
Board of Directors sets terms of the awards, including continuing employment conditions and performance conditions (measured
over three financial years).
The employee plans have a three-year vesting period, with no lock-up period.
•At its meeting of April 30, 2025, the Board of Directors awarded a share performance plan, cascaded down into three sub-plans:
–a plan under which 463 beneficiaries classified as “Senior Executives” were awarded a total of 1,331,892 shares;
–a plan under which 7,700 beneficiaries not classified as “Senior Executives” were awarded a total of 2,599,478 shares;
–a plan under which 90,000 performance shares were awarded to the Chief Executive Officer.
Of the 8,164 beneficiaries, 51% were women.
•At its meeting of October 23, 2025, the Board of Directors awarded a share performance plan, cascaded down into
two sub-plans:
–a plan under which 25 beneficiaries classified as “Senior Executives” were awarded a total of 107,291 performance shares;
–a plan under which 6 beneficiaries not classified as “Senior Executives” were awarded a total of 7,833 performance shares.
Of those 31 beneficiaries, 45% were women.
148 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
The entirety of those awards is contingent upon criteria based on business net income (BNI), free cash flow (FCF) and Corporate
Social Responsibility (CSR); in the case of employees classified as “Senior Executives”, two additional criteria based on (i) total
shareholder return (TSR) and (ii) the R&D allocation rate were added, accounting for respectively 20% and 10% of the total.
Vesting is subject to a non-compete clause.
The number of shares awarded to the Chief Executive Officer in 2025 represents 0.5% of the total limit approved by our
shareholders at the Annual General Meeting of April 30, 2025 (1.5% of our share capital) and 2.22% of the total amount awarded
to all beneficiaries in 2025.
The 2025 awards represent a dilution of approximately 0.21% of our undiluted share capital as of December 31, 2025.
Not all of our employees were awarded performance shares, but a new voluntary profit-sharing agreement was signed in June
2023, which gives all of our employees an interest in Sanofi’s performance (for more details refer to “— Profit-Sharing Schemes,
Employee Savings Schemes and Employee Share Ownership” above).
Performance Share Plans
Source | Date of shareholder authorization | Date of award | Total number of shares awarded | to corporate officers(a) | to the 10 employees awarded the most shares(b) | Start date of vesting period(c) | Vesting date | End of lock- up period | Number of shares vested as of 12/31/2025 | Number of rights canceled as of 12/31/2025(d) | Number of shares not yet vested |
Sanofi | Apr 30, 2021 | May 03, 2022 | 2,000,627 | — | 25,882 | May 03, 2022 | May 03, 2025 | May 04, 2025 | 1,711,911 | 288,716 | — |
Sanofi | Apr 30, 2021 | May 03, 2022 | 1,146,431 | — | 192,542 | May 03, 2022 | May 03, 2025 | May 04, 2025 | 900,070 | 246,361 | — |
Sanofi | Apr 30, 2021 | May 03, 2022 | 82,500 | 82,500 | — | May 03, 2022 | May 03, 2025 | May 04, 2025 | 69,597 | 12,903 | — |
Sanofi | Apr 30, 2021 | Dec 14, 2022 | 90,580 | — | 77,111 | Dec 14, 2022 | Dec 14, 2025 | Dec 15, 2025 | 86,267 | 4,313 | — |
Sanofi | Apr 30, 2021 | Dec 14, 2022 | 10,335 | — | 10,335 | Dec 14, 2022 | Dec 14, 2025 | Dec 15, 2025 | 10,068 | 267 | — |
Sanofi | Apr 30, 2021 | May 25, 2023 | 2,425,047 | — | 25,417 | May 25, 2023 | May 25, 2026 | May 25, 2026 | 2,550 | 390,779 | 2,031,718 |
Sanofi | Apr 30, 2021 | May 25, 2023 | 1,209,790 | — | 192,417 | May 25, 2023 | May 25, 2026 | May 25, 2026 | 261,798 | 947,992 | |
Sanofi | Apr 30, 2021 | May 25, 2023 | 82,500 | 82,500 | — | May 25, 2023 | May 25, 2026 | May 25, 2026 | 82,500 | ||
Sanofi | Apr 30, 2021 | Dec 13, 2023 | 58,347 | — | 58,347 | Dec 13, 2023 | Dec 14, 2026 | Dec 14, 2026 | 58,347 | ||
Sanofi | Apr 30, 2021 | Dec 13, 2023 | 944 | — | 944 | Dec 13, 2023 | Dec 14, 2026 | Dec 14, 2026 | 944 | ||
Sanofi | Apr 30, 2024 | Apr 30, 2024 | 2,888,502 | — | 25,656 | Apr 30, 2024 | May 01, 2027 | May 02, 2027 | 1,595 | 381,605 | 2,505,302 |
Sanofi | Apr 30, 2024 | Apr 30, 2024 | 1,394,478 | — | 244,434 | Apr 30, 2024 | May 01, 2027 | May 02, 2027 | 195,366 | 1,199,112 | |
Sanofi | Apr 30, 2024 | Apr 30, 2024 | 82,500 | 82,500 | — | Apr 30, 2024 | May 01, 2027 | May 02, 2027 | 82,500 | ||
Sanofi | Apr 30, 2024 | Dec 04, 2024 | 6,649 | — | 6,649 | Dec 04, 2024 | Dec 05, 2027 | Dec 06, 2027 | 6,649 | ||
Sanofi | Apr 30, 2024 | Dec 04, 2024 | 82,222 | — | 76,702 | Dec 04, 2024 | Dec 05, 2027 | Dec 06, 2027 | 6,052 | 76,170 | |
Sanofi | Apr 30, 2024 | Apr 30, 2025 | 90,000 | 90,000 | — | Apr 30, 2025 | May 01, 2028 | May 02, 2028 | — | 90,000 | |
Sanofi | Apr 30, 2024 | Apr 30, 2025 | 1,331,892 | — | 242,948 | Apr 30, 2025 | May 01, 2028 | May 02, 2028 | 30,296 | 1,301,596 | |
Sanofi | Apr 30, 2024 | Apr 30, 2025 | 2,599,478 | — | 249,999 | Apr 30, 2025 | May 01, 2028 | May 02, 2028 | 75,986 | 2,523,492 | |
Sanofi | Apr 30, 2024 | Oct 23, 2025 | 107,291 | — | 80,161 | Oct 23, 2025 | Oct 23, 2028 | Oct 23, 2028 | — | 107,291 | |
Sanofi | Apr 30, 2024 | Oct 23, 2025 | 7,833 | — | 7,833 | Oct 23, 2025 | Oct 23, 2028 | Oct 23, 2028 | 7,833 |
(a)Comprises the Chief Executive Officer, and any Deputy Chief Executive Officers or members of the Management Board in office at the date of grant.
(b)In office at the date of grant.
(c)Subject to the conditions set.
(d)12,903 rights were cancelled due to partial non-fulfillment of performance condition.
As of December 31, 2025, 11,021,446 shares had not yet vested pending fulfillment of performance conditions.
SANOFI FORM 20-F 2025 | 149 |
PART I |
ITEM 6. Directors, Senior Management and Employees |
Shares Owned by Members of the Board of Directors
As of December 31, 2025, members of our Board of Directors held in the aggregate 1224,077 shares, or under 1% of the share
capital and of the voting rights, excluding the beneficial ownership of 88,670,657 shares held by L’Oréal as of that date, which
may be attributed to Barbara Lavernos or Christophe Babule (who disclaim beneficial ownership of such shares).
Transactions in Shares by Members of the Board of Directors and Equivalent Persons in 2025 and
early 2026
As far as Sanofi is aware, transactions in our securities carried out during 2025 and early 2026 by (i) Board members,
(ii) executives with the power to make management decisions affecting our future development and corporate strategy and
(iii) persons with close personal ties to such individuals (as per Article L. 621-18-2 of the French Monetary and Financial Code),
were as follows:
•On February 5, 2025, Jean-Paul Kress, Director, acquired 2,000 ADSs at a unit price of $53.12;
•On April 2, 2025, John Sundy, Director, acquired 1,000 ADSs at a unit price of $55.03;
•On May 5, 2025, Paul Hudson, Chief Executive Officer, acquired 69,597 bonus shares;
•On June 6, 2025, Wolfgang Laux, Director representing employees, acquired 6.80 FCPE units at a unit price of €88.27;
•On June 26, 2025, Clotilde Delbos, Director, acquired 500 shares at a unit price of €82.70;
•On July 24, 2025, Wolfgang Laux, employee representative administrator, acquired 300 FCPE shares at a unit price of
72.97 euros.
F. Disclosure of action to recover erroneously awarded compensation
N/A
150 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 7. Major Shareholders and Related Party Transactions |
Item 7. Major Shareholders and Related Party Transactions
A. Major Shareholders
The table below shows the ownership of our shares as of January 31, 2026, indicating the beneficial owners of our shares. To the
best of our knowledge and on the basis of the notifications received as disclosed below, except for the shareholders mentioned in
the table below, no other shareholder currently holds more than 5% of our share capital or voting rights.
Total number of issued shares | Actual number of voting rights (excluding treasury shares)(d) | Theoretical number of voting rights (including treasury shares)(e) | ||||
Number | % | Number | % | Number | % | |
L’Oréal | 88,670,657 | 7.27 | 177,341,314 | 13.22 | 177,341,314 | 13.10 |
BlackRock(a) | 86,468,928 | 7.09 | 86,468,928 | 6.44 | 86,468,928 | 6.39 |
Employees(b) | 35,656,740 | 2.92 | 71,623,890 | 5.34 | 71,623,890 | 5.29 |
Public | 996,743,160 | 81.73 | 1,006,221,951 | 75.00 | 1,006,221,951 | 74.34 |
Treasury shares(c) | 11,962,777 | 0.98 | — | — | 11,962,777 | 0.88 |
Total | 1,219,502,262 | 100 | 1,341,656,083 | 100 | 1,353,618,860 | 100 |
(a)BlackRock, Inc. reported ownership of 72,127,649 ordinary shares on a Schedule 13G filed on April 23, 2025 (reported as representing 5.8% of Sanofi’s
share capital in the Schedule 13G). The amounts reported in the table are based on an ownership declaration from BlackRock, Inc. dated July 31, 2025
and provided pursuant to disclosure obligations related to crossing share ownership thresholds specified in Sanofi’s Articles of Association ("statuts").
(b)Shares held by the employees according to article L. 225-102 of the French Commercial Code as of December 31, 2025. Amundi (together with Amundi
Asset Management) filed a Schedule 13G on November 14, 2025 reporting ownership of 63,898,970 shares (reported as representing 5.21% of Sanofi’s
share capital in Schedule 13G), including 28,440,459 shares over which Amundi does not have voting rights, which are held through FCPEs (Fonds
Commun de Placement d'Entreprise, an investment vehicle established under French law) solely dedicated to Sanofi group employee share ownership,
the voting rights of which are exercised by the holders of FCPE units and/or the supervisory board of the FCPEs. Amundi stated that the voting rights
associated with these shares are exercised by the Supervisory Boards of the FCPEs and not by Amundi.
(c)Number of shares repurchased as of January 31, 2026 under the share repurchase programs approved by our shareholders from time to time.
(d)Based on the total number of voting rights as of January 31, 2026.
(e)Based on the total number of voting rights as of January 31, 2026 as published in accordance with Article 223-11 et seq. of the General Regulations of
the Autorité des marchés financiers (i.e. including treasury shares, the voting rights of which are suspended).
Our Articles of Association provide for double voting rights for shares held in registered form (i.e. where the ultimate shareholder’s
identity is recorded in our share register) for at least two years. All of our shareholders may benefit from double voting rights if
these conditions are met, and no shareholder benefits from specific voting rights. For more information relating to our shares, see
“Item 10. Additional Information — B. Memorandum and Articles of Association.”
Neither L’Oréal nor BlackRock holds different voting rights from those of our other shareholders.
To the best of our knowledge, no other shareholder currently holds, directly or indirectly and acting alone or in concert, more
than 5% of our share capital or voting rights. Furthermore, we believe that we are not directly or indirectly owned or controlled by
another corporation or government, or by any other natural or legal persons. To our knowledge, there are no arrangements that
may result in a change of control.
During the year ended December 31, 2025 we received one share ownership declaration from L'Oréal informing us that a legal
threshold had been passed, as required under Article L. 233-7 of the French Commercial Code. L'Oréal’s declaration stated that
on February 5, 2025 its ownership of Sanofi voting rights passed below the 15% legal threshold to 12.73% and that its current
ownership of share capital was 7.02%.
In addition to the statutory requirement to inform the Company and the Autorité des marchés financiers (AMF, the French
Financial Markets Regulator) that they hold a number of shares (or of securities equivalent to shares or of voting rights
pursuant to Article L. 233-9 of the French Commercial Code) representing more than one-twentieth (5%), one-tenth (10%),
three-twentieths (15%), one-fifth (20%), one-quarter (25%), three-tenths (30%), one-third (1/3), one-half (50%), two-thirds (2/3),
nine-tenths (90%) or nineteen-twentieths (95%) of the share capital or theoretical voting rights within four trading days after
crossing any such ownership threshold (Article L. 233-7 of the French Commercial Code), any natural or legal person who directly
or indirectly comes to hold a percentage of the share capital, voting rights or securities giving future access to the Company’s
capital that is equal to or greater than 1% or any multiple of that percentage, is obliged to inform the Company thereof by
registered mail, return receipt requested, indicating the number of securities held, within five trading days following the date on
which each of the thresholds was crossed.
If such declaration is not made, the shares in excess of the fraction that should have been declared will be stripped of voting
rights at shareholders’ meetings, if on the occasion of such meeting, the failure to declare has been formally noted and one or
more shareholders collectively holding at least 5% of the Company’s share capital or voting rights so request at that meeting.
Any natural or legal person is also required to inform the Company, in the forms and within the time limits stipulated above for
passing above a specified threshold, if their direct or indirect holding passes below any of the aforementioned thresholds.
Since January 1, 2026, Sanofi has only received share ownership declarations as required under Sanofi's Articles of Association.
SANOFI FORM 20-F 2025 | 151 |
PART I |
ITEM 7. Major Shareholders and Related Party Transactions |
As of December 31, 2025, Sanofi had approximately 28,048 shareholders listed in its share register, representing approximately
11.83% of issued shares. Based on the Sanofi share register and excluding treasury shares, approximately 97.94% of the shares
registered by name were held in France, and approximately 0.013% were held in the United States. In France, our country of
incorporation, there were 11,441 identified shareholders of record. In the United States, our host country, there were 54 identified
shareholders of record and 17,858 identified ADS holders of record.
Shareholders’ Agreement
We are unaware of any shareholders’ agreement currently in force.
B. Related Party Transactions
See Note D.33. to our consolidated financial statements included at Item 18. of this annual report.
On February 2, 2025, Sanofi and L'Oréal entered into a share buyback agreement pursuant to which Sanofi repurchased
Following the repurchase, and after cancellation on March 13, 2025 of said shares, as of December 31, 2025 L’Oréal held 7.27% of
Sanofi’s share capital and 13.10% of Sanofi’s effective voting rights (excluding treasury shares). For more information, see "Item 8.
Financial Information - B. Significant Changes".
C. Interests of Experts and Counsel
N/A
152 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 8. Financial Information |
Item 8. Financial Information
A. Consolidated Financial Statements and Other Financial Information
Our consolidated financial statements as of and for the years ended December 31, 2025, 2024 and 2023 are included of this
annual report at “Item 18. Financial Statements.”
Dividends on ordinary shares
We paid annual dividends for the years ended December 31, 2021, 2022, 2023 and 2024 and our shareholders will be asked to
approve the payment of an annual dividend of €4.12 per share for the 2025 fiscal year at our next annual shareholders’ meeting. If
approved, this dividend will be paid on May 7, 2026.
We expect that we will continue to pay regular dividends based on our financial condition and results of operations. The
proposed 2025 dividend equates to a distribution of 55.0% of our business net income. For information on the non-IFRS financial
measure “business earnings per share” see “Item 5. Operating and Financial Review and Prospects — Business Net Income.”
The following table sets forth information with respect to the dividends paid by our Company in respect of the 2021, 2022, 2023
and 2024 fiscal years and the dividend that will be proposed for approval by our shareholders in respect of the 2025 fiscal year at
our April 29, 2026 shareholders’ meeting.
2025 | (a) | 2024 | 2023 | 2022 | 2021 | (b) | |
Dividend per Share (€) | 4.12 | 3.92 | 3.76 | 3.56 | 3.33 |
(a)Proposal, subject to shareholder approval.
(b)Plus a dividend in kind of EUROAPI shares, at a ratio of one EUROAPI share per 23 Sanofi shares.
The declaration, amount and payment of any future dividends will be determined by majority vote of the holders of our shares at
an ordinary general meeting, following the recommendation of our Board of Directors. Any declaration will depend on our results
of operations, financial condition, cash requirements, future prospects and other factors deemed relevant by our shareholders.
Accordingly, we cannot assure you that we will pay dividends in the future on a continuous and regular basis. Under French law,
we are required to pay dividends approved by an ordinary general meeting of shareholders within nine months following the
meeting at which they are approved.
Disclosure pursuant to Section 13(r) of the United States Exchange Act of 1934
Sanofi engages in limited business activities with Iran related to human health products – namely, sales of bulk and branded
pharmaceuticals and vaccines. These activities, which are disclosed pursuant to Section 13(r) of the United States Exchange Act
of 1934, as amended, are not financially material to Sanofi and contributed well under 1% of Sanofi’s consolidated net sales
in 2025.
Sanofi’s US affiliates and non-US affiliates owned or controlled by Sanofi’s US affiliates either do not engage in Iran-related
activities or act under licenses issued by the US Department of the Treasury’s Office of Foreign Assets Control (OFAC).
Sanofi and certain non-US Sanofi affiliates engage in limited business activities that neither are expressly authorized by OFAC nor
require such authorization.
In 2016, Sanofi and the Iran Food and Drug Administration (IFDA), an entity affiliated with the Iranian Ministry of Health and
Medical Education, signed a Memorandum of Cooperation (MOC) regarding: (i) potential future projects to reinforce current
partnerships with reputable Iranian manufacturers (in particular, to enhance industrial quality standards); (ii) collaborating with
the Ministry of Health and Medical Education on programs for the prevention and control of certain chronic and
non-communicable diseases (in particular, diabetes); and (iii) potential future collaboration on epidemiological studies. In 2025,
activities conducted under the MOC did not generate any revenue or net profits.
Certain non-US Sanofi affiliates engage in limited business with Iranian counterparties associated with the Iranian Ministry of
Health, such as public hospitals or distributors. In 2025, those business activities generated approximately €28.4 million in gross
revenue and contributed no more than €6.5 million in net profit.
Finally, a representative office in Tehran currently under liquidation incurs incidental expenses from state-owned utilities.
Sanofi believes that it and its affiliates’ activities are compliant with applicable law, and in light of the nature of the activities
concerned, Sanofi and its affiliates intend to continue their ongoing activities in Iran.
SANOFI FORM 20-F 2025 | 153 |
PART I |
ITEM 8. Financial Information |
Information on Legal or Arbitration Proceedings
This Item 8. incorporates by reference the disclosures found in Note D.22. to the consolidated financial statements at
Item 18. of this annual report; material updates thereto as of the date of this annual report are found below under the
heading “— B. Significant Changes — Updates to Note D.22.”.
Sanofi and its subsidiaries are involved in litigation, arbitration and other legal proceedings. These proceedings typically are
related to product liability claims, intellectual property rights (particularly claims against generic companies seeking to limit the
patent protection of Sanofi products), competition law and trade practices, commercial claims, employment and wrongful
discharge claims, tax assessment claims, waste disposal and pollution claims, and claims under warranties or indemnification
arrangements relating to business divestitures. As a result, we may become subject to substantial liabilities that may not be
covered by insurance and could affect our business and reputation. While we do not currently believe that any of these legal
proceedings will have a material adverse effect on our financial position, litigation is inherently unpredictable. As a
consequence, we may in the future incur judgments or enter into settlements of claims that could have a material adverse
effect on results of operations, cash flows and/or our reputation.
Government Investigations and Related Litigation
From time to time, subsidiaries of Sanofi are subject to governmental investigations and information requests from regulatory
authorities inquiring as to the practices of Sanofi with respect to the sales, marketing, and promotion of its products. Sanofi US
has been subject to a number of government investigations and legal actions in the United States related to the pricing of
Sanofi’s insulin products (including Sanofi’s pricing practices for Lantus, Toujeo and/or Soliqua). The insulin-pricing litigation has
been consolidated in Multi-District Litigation (MDL) in New Jersey Federal Court, and includes claims by state attorneys general,
self-funded payors, and other plaintiffs. Sanofi has resolved some cases through settlement or dismissal and has also secured the
dismissal of some claims in the MDL; other claims are proceeding into discovery. Sanofi subsidiaries are also defending (i) an
insulin-related antitrust suit brought on behalf of direct purchasers in Massachusetts Federal Court, where a final decision on
summary judgment could come by the end of March 2026; and (ii) an antitrust suit brought by Mylan (relating to Mylan’s insulin
product, Semglee) in the Federal Court in the Western District of Pennsylvania.
In September 2019, Sanofi US received a Civil Investigative Demand (CID) from the US Department of Justice (DOJ)
concerning Dupixent, Kevzara, Praluent and Zaltrap, and Sanofi is defending the related non-intervened False Claims Act lawsuit
currently on appeal before the Ninth Circuit Court of Appeals following dismissal at the district court level.
In May 2025, Sanofi US received a subpoena from the US Department of Health and Human Services Office of Inspector General
(HHS-OIG) in Philadelphia seeking information on agreements with pharmacy benefit managers (PBMs) and group purchasing
organizations (GPOs), including drug utilization data from 2020 to the present, as part of a joint investigation with the US
Department of Justice (DOJ) and the US Attorney’s Office for the Eastern District of Pennsylvania; Sanofi is cooperating.
In March 2025, Sanofi US received a Civil Investigative Demand (CID) from the US Department of Justice (DOJ) under the False
Claims Act requesting information on Beyfortus, an RSV (Respiratory Syncytial Virus) vaccine co-developed and commercialized
with a partner, referencing a May 2024 FDA inspection of a North Carolina manufacturing facility; Sanofi is cooperating.
In February 2024, Sanofi US was served with a qui tam complaint in Texas state court alleging violations of the Texas Medicaid
Fraud Prevention Act (TMFPA). The complaint alleges that the Company engaged outside vendors to provide nursing and
reimbursement services related to certain insulin products in violation of the TMFPA. In October 2025, the relator filed an
amended petition expanding the allegations to include seven additional products: Altuviiio, Aubagio, Cerdelga, Nexviazyme,
Dupixent, Rezurock, and Tzield. In January 2026, the State of Texas intervened in the case. Discovery is ongoing, with trial
scheduled for July 2027.
(1)The appointment of Belén Garijo as a director, as well as the amendment of the articles of association to raise the age limit of the Chief Executive Officer
upon appointment, necessary for this election, will be proposed to the vote of the shareholders at the General Meeting of April 29, 2026.
154 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 8. Financial Information |
B. Significant Changes
Updates to Note D.22.
340B Drug Pricing Program in the United States
The US Health Resources and Services Administration (HRSA) withdrew its 340B Rebate Model Pilot Program in February 2026
but is expected to announce a new 340B Rebate Model Pilot Program later in 2026.
Other Changes
On January 29, 2026, Sanofi announced its intention to execute a share buyback program in 2026 of €1 billion. On February 2,
2026, Sanofi entered a mandate with an investment service provider for this program. Under the terms of the mandate, Sanofi
will repurchase its own shares for a total consideration of up to €1 billion, between February 3, 2026 and December 31, 2026, at
the latest.
On February 10, 2026, Sanofi announced that it had completed the acquisition of Dynavax Technologies Corporation (Dynavax).
The acquisition includes Dynavax’s adult hepatitis B vaccine HEPLISAV-B, which is currently marketed in the US and is
differentiated by its two-dose regimen over one month. It also includes Dynavax’s shingles vaccine candidate (Z-1018), which is
currently in phase 1/2 studies, and additional vaccine pipeline projects.
On February 12, 2026, Sanofi announced that Sanofi's Board of Directors met on February 11, 2026, and decided not to renew the
Director mandate of Paul Hudson. As a result, Paul Hudson’s last day as Chief Executive Officer will be on February 17, 2026 at the
end of business. The Board thanks him for his valuable contributions to the transformation and development of the Group over
the last six years. Following the proposal of the Appointments, Governance and CSR Committee, the Board of Directors
appointed Belén Garijo as Chief Executive Officer. She will take up her duties after the Group's Annual General Meeting on
April 29, 2026. The Board will also propose to the shareholder vote the candidacy of Belén Garijo as a director of the Group(1).
Olivier Charmeil, Executive Vice President, General Medicines, and member of the Executive Committee since 2011, will assume
the role of Interim Chief Executive Officer during this transition.
On February 16, 2026, Sanofi announced that a universal respiratory syncytial virus (RSV) immunization program using Beyfortus
(nirsevimab) was associated with a statistically significant reduction in RSV-related hospitalizations in the second RSV season
among infants immunized during their first season, according to a new study published in The Lancet Infectious Diseases. The
NIRSE-GAL study, conducted in Galicia, Spain, is the first prospective real-world population study to evaluate the impact of a
universal Beyfortus immunization program during two consecutive RSV seasons. The study findings, comparing the number of
hospitalizations in immunized infants during their second RSV season versus the number of expected hospitalization cases based
on data from recent seasons, are being presented at RSVVW ’26 (Respiratory Syncytial Virus Vaccines for the World) conference
in Rome, Italy.
On February 17, 2026, Sanofi announced the nomination of Manuela Buxo as Executive Vice-President, Specialty Care, effective
March 1, 2026. Manuela will succeed Brian Foard, who has decided to leave the company as of February 28, 2026, having
accepted an external leadership opportunity.
SANOFI FORM 20-F 2025 | 155 |
PART I |
ITEM 9. The Offer and Listing |
Item 9. The Offer and Listing
A. Offer and Listing Details
We have one class of shares. Each American Depositary Share, or ADS, represents one-half of one share. The ADSs are evidenced
by American Depositary Receipts, or ADRs, which are issued by JPMorgan Chase Bank, NA.
Our shares trade on Compartment A of the regulated market of Euronext Paris under the symbol "SAN," and our ADSs trade on
the Nasdaq Global Select Market, or Nasdaq, under the symbol "SNY."
B. Plan of Distribution
N/A
C. Markets
Shares and ADSs
Our shares are listed on Euronext Paris under the symbol “SAN” and our ADSs are listed on the Nasdaq under the symbol “SNY.”
As of the date of this annual report, our shares are included in a large number of indices including the CAC 40 Index, the principal
French index published by Euronext Paris. This index contains 40 stocks selected among the top 100 companies based on free-
float capitalization and the most active stocks listed on the Euronext Paris market. The CAC 40 Index indicates trends in the
French stock market as a whole and is one of the most widely followed stock price indices in France.
Our shares are included in European indexes, such as the EURO STOXX 50, STOXX Europe 600 index, FTSE Eurofirst 300,
MSCI Europe, MSCI Pan Euro, Euronext 100, and STOXX Europe 600 Health Care. They are also included in American and
international indexes, such as the NASDAQ Composite, NASDAQ Health Care, S&P Global 100, MSCI World, and MSCI World
Pharmaceuticals.
Our shares are also part of the main extra-financial rating indices that take account of environmental, social, and governance
criteria (FTSE4Good and EURO STOXX 50 Low Carbon).
Trading by Sanofi in our own Shares
Under French law, a company may not issue shares to itself, but it may purchase its own shares in the limited cases described
at “Item 10. Additional Information — B. Memorandum and Articles of Association — Trading in Our Own Shares.”
D. Selling Shareholders
N/A
E. Dilution
N/A
F. Expenses of the Issue
N/A
156 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 10. Additional Information |
Item 10. Additional Information
A. Share Capital
N/A
B. Memorandum and Articles of Association
General
Our Company is a société anonyme, a form of limited liability company, organized under the laws of France. The LEI number of
the Company is 549300E9PC51EN656011.
In this section, we summarize material information concerning our share capital, together with material provisions of applicable
French law and our Articles of Association (statuts), an English translation of which has been filed as an exhibit to this annual
report. For a description of certain provisions of our Articles of Association relating to our Board of Directors and statutory
auditors, see “Item 6. Directors, Senior Management and Employees." You may obtain copies of our Articles of Association in
French from the greffe (Clerk) of the Registre du Commerce et des Sociétés de Paris (Registry of Commerce and Companies of
Paris, France, registration number: 395 030 844). Please refer to that full document for additional details.
Our Articles of Association specify that our corporate affairs are governed by:
•applicable laws and regulations (in particular, Title II of the French Commercial Code); and
•the Articles of Association themselves.
Article 3 of our Articles of Association specifies that the Company’s corporate purpose, in France and abroad, is:
•acquiring interests and holdings, in any form whatsoever, in any company or enterprise, in existence or to be created,
connected directly or indirectly with the health and fine chemistry sectors, human and animal therapeutics, nutrition and
bio-industry:
–in the following areas:
•purchase and sale of all raw materials and products necessary for these activities,
•research, study and development of new products, techniques and processes,
•manufacture and sale of all chemical, biological, dietary and hygienic products,
•obtaining or acquiring all intellectual property rights related to results obtained and, in particular, filing all patents,
trademarks and models, processes or inventions,
•operating directly or indirectly, purchasing, and transferring – for free or for consideration – pledging or securing all
intellectual property rights, particularly all patents, trademarks and models, processes or inventions,
•obtaining, operating, holding and granting all licenses,
•within the framework of a group-wide policy and subject to compliance with the relevant legislation, participating in
treasury management transactions, whether as lead company or otherwise, in the form of centralized currency risk
management or intra-group netting, or any other form permitted under the relevant laws and regulations,
•acquiring any real estate assets in connection with the corporate purpose, or selling real estate assets owned by the company;
–and, more generally:
•all commercial, industrial, real or personal property, financial or other transactions, connected directly or indirectly,
totally or partially, with the activities described above and with all similar or related activities and even with any other
purposes likely to encourage or develop the Company’s activities.
Directors
Transactions in which directors are materially interested
Under French law, any agreement entered into (directly or through an intermediary) between our Company and any one of the
members of the Board of Directors that is not entered into (i) in the ordinary course of our business and (ii) under normal
conditions, is subject to the prior authorization of the disinterested members of the Board of Directors. The same provision
applies to agreements between our Company and another company if one of the members of the Board of Directors is the
owner, general partner, manager, director, general manager or member of the executive or supervisory board of the other
company, as well as to agreements in which one of the members of the Board of Directors has an indirect interest.
SANOFI FORM 20-F 2025 | 157 |
PART I |
ITEM 10. Additional Information |
The Board of Directors must also approve any undertaking taken by our Company for the benefit of our Chairman, Chief
Executive Officer (directeur général) or his delegates (directeurs généraux délégués) pursuant to which such persons will or may
be granted compensation, benefits or any other advantages as a result of the termination of or a change in their offices or
following such termination or change, in accordance with Article L. 22-10-8 III of the French Commercial Code. Each such
undertaking must be included in our compensation policy for corporate officers, which is submitted for approval by our
shareholders at the Annual General Meeting in accordance with Article L. 22-10-8 II of the French Commercial Code. No such
compensation or undertaking may be determined, awarded or paid unless in accordance with such compensation policy.
See “Item 6. Directors, Senior Management and Employees — B. Compensation” for a description of the process for establishing
and authorizing such compensation policy.
Directors’ compensation
The aggregate amount of compensation of the Board of Directors is determined at the Shareholders’ Ordinary General Meeting.
The Board of Directors then divides this aggregate amount among its members by a simple majority vote. In addition, the Board
of Directors may grant exceptional compensation (rémunérations exceptionnelles) to individual directors on a case-by-case basis
for special assignments following the procedures described above at “— Transactions in which directors are materially
interested”. The Board of Directors may also authorize the reimbursement of travel and accommodation expenses, as well as
other expenses incurred by Directors in the corporate interest. See also “Item 6. Directors, Senior Management and Employees.”
Furthermore, under our Articles of Association, the Board of Directors may compensate any observers (censeurs) to the Board of
Directors, which would reduce by the same amount the total annual compensation available for allocation to the Board of
Directors.
Board of Directors’ authority to take out loans or borrow money on behalf of the Company
All loans or borrowings on behalf of the Company may be decided by the Board of Directors within the limits, if any, imposed by
the Shareholders’ Extraordinary General Meeting. There are currently no limits imposed on the amounts of loans or borrowings
that the Board of Directors may approve.
Directors’ age limits
For a description of the provisions of our Articles of Association relating to age limits applicable to our Directors, see
“Item 6. Directors, Senior Management and Employees – A. Directors and Senior Management."
Directors’ share ownership requirements
Pursuant to our Articles of Association, each director appointed by a Shareholders’ Ordinary General Meeting must own at
least 500 shares throughout their term of office. In addition, pursuant to the Board Charter (an English language version of which
is reproduced in full as Exhibit 1.2 to this annual report), our Directors must within no more than two years from their appointment
hold at least 1,000 Sanofi shares in their own name, which must be retained until they cease to hold office.
Shareholders’ meetings
General
In accordance with the provisions of the French Commercial Code, there are three types of shareholders’ meetings: ordinary,
extraordinary and special.
Ordinary general meetings of shareholders are required for matters such as:
•electing, replacing and removing Directors;
•appointing independent auditors;
•approving the annual financial statements;
•declaring dividends or authorizing dividends to be paid in shares, provided the Articles of Association contain a provision to
that effect; and
•approving share repurchase programs.
Extraordinary general meetings of shareholders are required for approval of matters such as amendments to our Articles of
Association, including any amendment required in connection with extraordinary corporate actions. Extraordinary corporate
actions include:
•changing our Company’s name or corporate purpose;
•increasing or decreasing our share capital;
•creating a new class of equity securities;
•authorizing the issuance of:
–shares giving access to our share capital or giving the right to receive debt instruments, or
–other securities giving access to our share capital;
•establishing any other rights to equity securities;
158 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 10. Additional Information |
•selling or transferring substantially all of our assets; and
•the voluntary liquidation of our Company.
Special meetings of shareholders of a certain category of shares or shares with certain specific rights (such as shares with double
voting rights) are required for any modification of the rights derived from that category of shares. The resolutions of the
shareholders’ general meeting affecting these rights are effective only after approval by the relevant special meeting.
Annual ordinary meetings
The French Commercial Code requires the Board of Directors to convene an annual ordinary general shareholders’ meeting to
approve the annual financial statements. This meeting must be held within six months of the end of each fiscal year.
The Board of Directors may also convene an ordinary or extraordinary general shareholders’ meeting upon proper notice at any
time during the year. If the Board of Directors fails to convene a shareholders’ meeting, our independent auditors may call the
meeting. In case of bankruptcy, the liquidator or court-appointed agent may also call a shareholders’ meeting in some instances.
In addition, any of the following may request the court to appoint an agent for the purpose of calling a shareholders’ meeting:
•one or several shareholders holding at least 5% of our share capital;
•duly qualified associations of shareholders who have held their shares in registered form for at least two years and who
together hold at least 1% of our voting rights;
•the works council in cases of urgency; or
•any interested party in cases of urgency.
Under our Articles of Association, the Board of Directors may take decisions by written consultation under the conditions
permitted by law and as specified in the Board Charter, including the possibility to convene an ordinary or extraordinary general
meeting.
Notice of shareholders’ meetings
All prior notice periods provided for below are minimum periods required by French law and cannot be shortened, except in case
of a public tender offer for our shares.
We must announce general meetings at least thirty-five days in advance by means of a preliminary notice (avis de réunion), which
is published in the Bulletin des Annonces Légales Obligatoires, or BALO. The preliminary notice must first be sent to the French
Financial markets authority (Autorité des marchés financiers, the “AMF”), with an indication of the date on which it will be
published in the BALO. It must be published on our website at least twenty-one days prior to the general meeting. The
preliminary notice must contain, among other things, the agenda, a draft of the resolutions to be submitted to the shareholders
for consideration at the general meeting and a detailed description of the voting procedures (proxy voting, electronic voting or
voting by mail), the procedures permitting shareholders to submit additional resolutions or items to the agenda and to ask written
questions to the Board of Directors. The AMF also recommends that, prior to or simultaneously with the publication of the
preliminary notice, we publish a summary of the notice indicating the date, time and place of the meeting in a newspaper of
national circulation in France and on our website.
At least fifteen days prior to the date set for a first convening, and at least ten days prior to any second convening, we must send
a final notice (avis de convocation) containing the final agenda, the date, time and place of the meeting and other information
related to the meeting. Such final notice must be sent by mail to all registered shareholders who have held shares in registered
form for more than one month prior to the date of the final notice and by registered mail, if shareholders have asked for it and
paid the corresponding charges. The final notice must also be published in a newspaper authorized to publish legal
announcements in the local administrative department (département) in which our Company is registered as well as in the BALO,
with prior notice having been given to the AMF for informational purposes. Even if there are no proposals for new resolutions or
items to be submitted to the shareholders at the meeting, we must publish a final notice in a newspaper authorized to publish
legal announcements in the local administrative department (département) in which our Company is registered as well as in
the BALO.
Other issues
In general, shareholders can only take action at shareholders’ meetings on matters listed on the agenda. As an exception to this
rule, shareholders may take action with respect to the appointment and dismissal of directors even if this action has not been
included on the agenda.
Additional resolutions to be submitted for approval by the shareholders at the shareholders’ meeting may be proposed to the
Board of Directors, for recommendation to the shareholders at any time from the publication of the preliminary notice in
the BALO until twenty-five days prior to the general meeting and in any case no later than twenty days following the publication
of the preliminary notice in the BALO by:
•one or several shareholders together holding a specified percentage of shares;
•a duly qualified association of shareholders who have held their shares in registered form for at least two years and who
together hold at least 1% of our voting rights; or
•the works council.
SANOFI FORM 20-F 2025 | 159 |
PART I |
ITEM 10. Additional Information |
Within the same period, the shareholders may also propose additional items (points) to be submitted and discussed during the
shareholders’ meeting, without a shareholders’ vote. The shareholders must substantiate the reasons for their proposals of
additional items.
The resolutions and the list of items added to the agenda of the shareholders’ meeting must be promptly published on
our website.
The Board of Directors must submit the resolutions to a vote of the shareholders after having made a recommendation thereon.
The Board of Directors may also comment on the items that are submitted to the shareholders’ meeting.
Following the date on which documents must be made available to the shareholders (including documents to be submitted to the
shareholders’ meeting and resolutions proposed by the Board of Directors, which must be published on our website at least
twenty-one days prior to the general meeting), shareholders may submit written questions to the Board of Directors relating to
the agenda for the meeting until the fourth business day prior to the general meeting. The Board of Directors must respond to
these questions during the meeting or may refer to a Q&A section located on our website in which the question submitted by a
shareholder has already been answered.
Attendance at shareholders’ meetings; proxies and votes by mail
In general, all shareholders may participate in general meetings either in person or by proxy. Shareholders may vote in person, by
proxy or by mail.
The right of shareholders to participate in general meetings is subject to the recording (inscription en compte) of their shares on
the fifth business day at 12:00 a.m. (Paris time), preceding the general meeting:
•for holders of registered shares: in the registered shareholder account held by the Company or on its behalf by an agent
appointed by it; and
•for holders of bearer shares: in the bearer shareholder account held by the accredited financial intermediary with whom such
holders have deposited their shares; such financial intermediaries shall deliver to holders of bearer shares a shareholding
certificate (attestation de participation) enabling them to participate in the general meeting.
Attendance in person
Any shareholder may attend ordinary general meetings and extraordinary general meetings and exercise its voting rights subject
to the conditions specified in the French Commercial Code, the French Civil Code and our Articles of Association.
An attendance sheet and written minutes are established for each shareholders’ meeting; failure to do so could lead to
cancellation of the decisions at the shareholders’ meeting.
Proxies and votes by mail
Proxies are sent to any shareholder upon a request received between the publication of the final notice of meeting and six days
before the general meeting and must be made available on our website at least twenty-one days before the general meeting. In
order to be counted, such proxies must be received at our registered office, or at any other address indicated on the notice of the
meeting or by any electronic mail indicated on the notice of the meeting, prior to the date of the meeting (in practice, we request
that shareholders return proxies at least three business days prior to the meeting; electronic proxies must be returned
before 3 p.m. Paris time, on the day prior to the general meeting). A shareholder may grant proxies to any natural person or legal
entity. The agent may be required to disclose certain information to the shareholder or to the public.
A proxy is only valid for one meeting (or by way of exception for two meetings, one being ordinary and the other extraordinary,
held on the same day or within a single 15-day period); it remains valid in the event such meeting is convened multiple times for
the same agenda, and may be revoked by written statement of the shareholder granting the proxy.
Alternatively, the shareholder may send us a blank proxy without nominating any representative. In this case, the chairman of the
meeting will vote the blank proxies in favor of all resolutions proposed or approved by the Board of Directors and against
all others.
With respect to votes by mail, we must send shareholders a voting form upon request or must make available a voting form on our
website at least twenty-one days before the general meeting. The completed form must be returned to us at least three days
prior to the date of the shareholders’ meeting. For holders of registered shares, in addition to traditional voting by mail,
instructions may also be given via the Internet.
Quorum
The French Commercial Code requires that shareholders holding in the aggregate at least 20% of the shares entitled to vote
must be present in person, or vote by mail or by proxy, in order to fulfill the quorum requirement for:
•an ordinary general meeting; and
•an extraordinary general meeting where the only resolutions pertain to either (a) a proposed increase in our share capital
through incorporation of reserves, profits or share premium, or (b) the potential issuance of free share warrants in the event of
a public tender offer for our shares (Article L. 233-32 of the French Commercial Code).
For any other extraordinary general meeting the quorum requirement is at least 25% of the shares entitled to vote, held by
shareholders present in person, voting by mail or by proxy.
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ITEM 10. Additional Information |
For a special meeting of holders of a certain category of shares, the quorum requirement is one third of the shares entitled to
vote in that category, held by shareholders present in person, voting by mail or by proxy.
If a quorum is not present at a meeting, the meeting is adjourned. However, only questions that were on the agenda of the
adjourned meeting may be discussed and voted upon once the meeting resumes.
When an adjourned meeting is resumed, there is no quorum requirement for meetings cited in the first paragraph of this
“Quorum” section. In the case of any other reconvened extraordinary general meeting or special meeting, the quorum
requirement is 20% of the shares entitled to vote (or voting shares belonging to the relevant category for special meetings of
holders of shares of such specific category), held by shareholders present in person or voting by mail or by proxy. If a quorum is
not met, the reconvened meeting may be adjourned for a maximum of two months with the same quorum requirement. No
deliberation or action by the shareholders may take place without a quorum.
C. Material Contracts
In the ordinary course of our business, we enter into agreements for licensing or collaboration in the development and
commercialization of products, as well as agreements for the purchase or sale of other businesses. Certain of the agreements
which have led to successful commercialization to date are summarized in “Item 5. Operating and financial review and prospects
— A.1.7 Financial presentation of alliances.”. Agreements in connection with the sale and purchase of a 50% controlling stake in
Opella are described in "Item 4. Information on the Company — B.3 Opella".
Share Repurchase Agreement with L'Oréal
On February 2, 2025, Sanofi and L'Oréal entered into a share buyback agreement pursuant to which Sanofi repurchased
29,556,650 shares from L’Oréal, a significant shareholder, at €101.50 per share, for a total amount of approximately €3 billion.
The transaction closed on February 5, 2025. Sanofi canceled the shares acquired from L'Oréal on March 13, 2025. As of
December 31, 2025, after the transaction and cancellation of the shares, L’Oréal held 7.27% of Sanofi’s share capital and 13.10% of
Sanofi’s effective voting rights (excluding treasury shares). For more information, see “Item 3. Key Information – D. Risk Factors –
Our largest shareholder owns a significant percentage of the share capital and voting rights of Sanofi” and “Item 7. Major
Shareholders and Related Party Transactions – A. Major Shareholders.”
D. Exchange Controls
French exchange control regulations currently do not limit the amount of payments that we may remit to non-residents of
France. Laws and regulations concerning foreign exchange controls do require, however, that all payments or transfers of funds
made by a French resident to a non-resident be handled by an accredited intermediary.
E. Taxation
General
The following generally summarizes the material French and US federal income tax consequences to US holders (as defined
below) of purchasing, owning and disposing of our ADSs and ordinary shares (collectively the “Securities”). This discussion is
intended only as a descriptive summary and does not purport to be a complete analysis or listing of all potential tax effects of the
purchase, ownership or disposition of our Securities. All of the following is subject to change. Such changes could apply
retroactively and could affect the consequences described below.
The French Finance Bill for 2026 (Loi de finances pour 2026), adopted by the French Parliament on February 2, 2026, remains
subject to review by the French Constitutional Council prior to its official promulgation. However, no material amendments are
expected to result from such review, and the version currently adopted of the French Finance Bill for 2026 is not expected to
entail material tax consequences for US holders.
This summary does not constitute a legal opinion or tax advice. Holders are urged to consult their own tax advisers regarding
the tax consequences of the purchase, ownership and disposition of Securities in light of their particular circumstances,
including the effect of any US federal, state, local or other national tax laws.
A set of tax rules is applicable to French assets that are held by or in foreign trusts. These rules provide inter alia for the inclusion
of trust assets in the settlor’s net assets for purpose of applying the French real estate wealth tax, for the application of French
gift and death duties to French assets held in trust, for a specific tax on capital on the French assets of foreign trusts not already
subject to the French real estate wealth tax and for a number of French tax reporting and disclosure obligations. The following
discussion does not address the French tax consequences applicable to Securities held in trusts. If Securities are held in trust, the
grantor, trustee and beneficiary are urged to consult their own tax adviser regarding the specific tax consequences of acquiring,
owning and disposing of Securities.
The description of the French and US federal income tax consequences set forth below is based on the laws (including, for
US federal income tax purposes, the Internal Revenue Code of 1986, as amended (the “Code”), final, temporary and proposed
US Treasury Regulations promulgated thereunder and administrative and judicial interpretations thereof) in force as of the date
of this annual report, the Convention Between the Government of the United States of America and the Government of the
French Republic for the Avoidance of Double Taxation and the Prevention of Fiscal Evasion with Respect to Taxes on Income and
Capital of August 31, 1994 (the “Treaty”), which entered into force on December 30, 1995 (as amended by any subsequent
protocols, including the protocol of January 13, 2009), and the tax regulations issued by the French tax authorities within the
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ITEM 10. Additional Information |
Bulletin Officiel des Finances Publiques-Impôts (the “Regulations”) in force as of the date of this report. US holders are advised to
consult their own tax advisers regarding their eligibility for Treaty benefits, especially with regard to the “Limitations on
Benefits” provision, in light of their own particular circumstances.
No advance ruling has been obtained with respect to the tax consequences of the acquisition, ownership or disposition of the
Securities from either the French or US tax authorities. Thus, there can no assurances that either or both of such authorities will
not take a position concerning said tax consequences different from that set out herein or that such a position would not be
sustained by a court.
For the purposes of this discussion, a US holder is a beneficial owner of Securities that is (i) an individual who is a US citizen or
resident for US federal income tax purposes, (ii) a US domestic corporation created or organized in or under the laws of the
United States or any state thereof, including the District of Columbia, or (iii) certain estates or trusts that are subject to US tax
jurisdiction.
If a partnership holds Securities, the tax treatment of a partner generally will depend upon the status of the partner and the
activities of the partnership. If a US holder is an estate or trust or partner in a partnership that holds Securities, the holder is
urged to consult its own tax adviser regarding the specific tax consequences of acquiring, owning and disposing of Securities.
This discussion is intended only as a general summary and does not purport to be a complete analysis or listing of all potential tax
effects of the acquisition, ownership or disposition of the Securities to any particular investor, and does not discuss tax
considerations that arise from rules of general application or that are generally assumed to be known by investors. The discussion
applies only to investors that hold our Securities as capital assets that have the US dollar as their functional currency, that are
entitled to Treaty benefits under the “Limitation on Benefits” provision contained in the Treaty, and whose ownership of the
Securities is not effectively connected to a permanent establishment or a fixed base in France. Certain holders (including, but not
limited to, US expatriates, partnerships or other entities classified as partnerships for US federal income tax purposes, banks,
insurance companies, regulated investment companies, tax-exempt organizations, financial institutions, persons subject to the
alternative minimum tax, persons who acquired the Securities pursuant to the exercise of employee stock options or otherwise as
compensation, persons that own (directly, indirectly or by attribution) 5% or more of our voting stock or 5% or more of our
outstanding share capital, dealers in securities or currencies, persons that elect to mark their securities to market for US federal
income tax purposes, persons that acquire ADSs in “pre-release” transactions (i.e. prior to deposit of the relevant ordinary shares,
although our depositary has indicated that such transactions have been halted) and persons holding Securities as a position in a
synthetic security, straddle or conversion transaction) may be subject to special rules not discussed below. Holders of Securities
are advised to consult their own tax advisers with regard to the application of French tax law and US federal tax law to their
particular situations, as well as any tax consequences arising under the laws of any state, local or other foreign jurisdiction.
French taxes
Estate and gift taxes and transfer taxes
In general, a transfer of Securities by gift or by reason of death of a US holder that would otherwise be subject to French gift or
inheritance tax, respectively, will not be subject to such French tax by reason of the Convention between the Government of the
United States of America and the Government of the French Republic for the Avoidance of Double Taxation and the Prevention
of Fiscal Evasion with Respect to Taxes on Estates, Inheritances and Gifts, dated November 24, 1978, unless the donor or the
transferor is domiciled in France at the time of making the gift or at the time of his or her death, or the Securities were used in, or
held for use in, the conduct of a business through a permanent establishment or a fixed base in France.
Pursuant to Article 235 ter ZD of the French General Tax Code, purchases of Securities are currently subject to a 0.3% French tax
on financial transactions (the “FTFF”). According to Article 26 quater of the Finance Bill for 2025, the rate of the FTFF will be
increased to 0.4% for purchases of Securities as from the first day of the second month following the enactment of the Finance
Bill for 2025. Purchases of Securities are subject to the FTFF provided that Sanofi’s market capitalization exceeds €1 billion as of
December 1 of the year preceding the taxation year. A list of companies whose market capitalization exceeds €1 billion as of
December 1 of the year preceding the taxation year used to be published annually by the French Ministry of Economy. It is now
published by the French tax authorities, and could be amended at any time. Pursuant to Regulations BOI-
ANNX-000467-17/12/2025 issued on December 17, 2025, purchases of Sanofi’s Securities in 2026 should be subject to the FTFF
as the market capitalization of Sanofi exceeded €1 billion as of December 1, 2025. In accordance with Article 726-II-d of the
French General Tax Code, purchases which are subject to the FTFF should however not be subject to transfer taxes (droits
d’enregistrement) in France.
Wealth tax
The French wealth tax (impôt de solidarité sur la fortune) has been replaced with a French real estate wealth tax (impôt sur la
fortune immobilière) with effect from January 1, 2018. French real estate wealth tax applies only to individuals and does not
generally apply to the Securities if the holder is a US resident, as defined pursuant to the provisions of the Treaty, provided that
the individual does not own directly or indirectly a shareholding exceeding 10% of the financial rights and voting rights.
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ITEM 10. Additional Information |
US taxes
Ownership of the securities
Deposits and withdrawals by a US holder of ordinary shares in exchange for ADSs, will not be taxable events for US federal
income tax purposes. For US tax purposes, holders of ADSs will be treated as owners of the ordinary shares represented by such
ADSs. Accordingly, the discussion that follows regarding the US federal income tax consequences of acquiring, owning and
disposing of ordinary shares is equally applicable to ADSs.
Information reporting and backup withholding tax
Distributions made to holders and proceeds paid from the sale, exchange, redemption or disposal of Securities may be subject to
information reporting to the Internal Revenue Service. Such payments may be subject to backup withholding taxes unless the holder
(i) is a corporation or other exempt recipient or (ii) provides a taxpayer identification number and certifies that no loss of exemption
from backup withholding has occurred. Holders that are not US persons generally are not subject to information reporting or backup
withholding. However, such a holder may be required to provide a certification of its non-US status in connection with payments
received within the United States or through a US-related financial intermediary to establish that it is an exempt recipient. Backup
withholding is not an additional tax. Amounts withheld as backup withholding may be credited against a holder’s US federal income
tax liability. A holder may obtain a refund of any excess amounts withheld under the backup withholding rules by filing the
appropriate claim for refund with the Internal Revenue Service and furnishing any required information.
Foreign asset reporting
In addition, a US holder that is an individual or certain entities may be subject to reporting obligations with respect to ordinary
shares and ADSs if the aggregate value of these and certain other “specified foreign financial assets” exceeds $50,000 on
the last day of the tax year or more than $75,000 at any time during the tax year. If required, this disclosure is made by
filing Form 8938 with the US Internal Revenue Service. Significant penalties can apply if holders are required to make this
disclosure and fail to do so. In addition, a US holder should consider the possible obligation to file online a FinCEN Form 114 –
Foreign Bank and Financial Accounts Report as a result of holding ordinary shares or ADSs. Holders are encouraged to consult
their US tax advisors with respect to these and other reporting requirements that may apply to their acquisition of ordinary shares
and ADSs.
State and local taxes
In addition to US federal income tax, US holders of Securities may be subject to US state and local taxes with respect to such
Securities. Holders of Securities are advised to consult their own tax advisers with regard to the application of US state and local
income tax law to their particular situation.
ADSs-Ordinary Shares
French taxes
Taxation of dividends
Under French law, dividends paid by a French corporation, such as Sanofi, to non-residents of France are generally subject to
French withholding tax at a rate of (i) 25% for payments benefiting legal persons who are beneficial owners and are not French
tax residents (and 15% for distributions made to not-for-profit organizations with a head office in a Member State of the European
Economic Area which would be subject to the tax regime set forth under Article 206 paragraph 2 of the French General Tax Code
if its head office were located in France and which meet the criteria set forth in the Regulations BOI-RPPM-
RCM-30-30-10-70-24/12/2019, No. 130), and (ii) 12.8% for payments benefiting individuals who are beneficial owners and are not
French tax residents. Dividends paid by a French corporation, such as Sanofi, towards non-cooperative States or territories, as
defined in Article 238-0 A of the French General Tax Code (other than those mentioned in 2° of 2 bis of the same Article 238-0 A
of the French Tax Code), will generally be subject to French withholding tax at a rate of 75%, irrespective of the tax residence of
the beneficiary of the dividends if the dividends are received in such States or territories; however, eligible US holders entitled to
Treaty benefits under the “Limitation on Benefits” provision contained in the Treaty who are US residents, as defined pursuant to
the provisions of the Treaty and who receive dividends in non-cooperative States or territories, will not be subject to this 75%
withholding tax rate.
Under the Treaty, the rate of French withholding tax on dividends paid to an eligible US holder who is a US resident as defined
pursuant to the provisions of the Treaty and whose ownership of the ordinary shares or ADSs is not effectively connected with a
permanent establishment or fixed base that such US holder has in France, is reduced to 15%, or to 5% if such US holder is a
corporation and owns directly or indirectly at least 10% of the share capital of the issuing company; such US holder may claim a
refund from the French tax authorities of the amount withheld in excess of the Treaty rates of 15% or 5%, if any. For US holders
that are not individuals but are US residents, as defined pursuant to the provisions of the Treaty, the requirements for eligibility
for Treaty benefits, including the reduced 5% or 15% withholding tax rates contained in the “Limitation on Benefits” provision
of the Treaty, are complicated, and certain technical changes were made to these requirements by the protocol of
January 13, 2009. US holders are advised to consult their own tax advisers regarding their eligibility for Treaty benefits in light of
their own particular circumstances.
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ITEM 10. Additional Information |
Dividends paid to an eligible US holder may immediately be subject to the reduced rates of 5% or 15% provided that such holder
establishes before the date of payment that it is a US resident under the Treaty by completing and providing the depositary with
a treaty form (Form 5000). Dividends paid to a US holder that has not filed the Form 5000 before the dividend payment date will
be subject to French withholding tax at the rate of 25% and then reduced at a later date to 5% or 15%, provided that such holder
duly completes and provides the French tax authorities with the treaty forms Form 5000 and Form 5001 (due to recent case law
regarding the status of limitations for filing a withholding tax claim, US holders are advised to consult their own tax advisors in this
respect). Pension funds and certain other tax-exempt entities are subject to the same general filing requirements as other
US holders except that they may have to supply additional documentation evidencing their entitlement to these benefits.
The depositary agrees to use reasonable efforts to follow the procedures established, or that may be established, by the French
tax authorities (i) to enable eligible US holders to qualify for the reduced withholding tax rate provided by the Treaty, if available
at the time the dividends are paid, or (ii) to recover any excess French withholding taxes initially withheld or deducted with
respect to dividends and other distributions to which such US holders may be eligible from the French tax authorities and (iii) to
recover any other available tax credits. In particular, associated forms (including Form 5000 and Form 5001, together with their
instructions), will be made available by the depositary to all US holders registered with the depositary, and are also generally
available from the US Internal Revenue Service.
The withholding tax refund, if any, ordinarily is paid within 12 months of filing the applicable French Treasury Form, but not before
January 15 of the year following the calendar year in which the related dividend is paid.
In addition, please note that, pursuant to Article 235 quater of the French Tax Code and under certain conditions (in particular, in
addition to certain reporting obligations, the interest held in the distributing company must not enable the beneficiary to
participate effectively in the management or control of that company and the beneficiary company must be located in a country
that has signed an administrative assistance agreement with France to combat tax evasion and avoidance, as well as an
administrative assistance agreement on tax collection, and that is not a non-cooperative country), a corporate US holder in a tax
loss position or whose tax result is nil due to offset of tax losses for the fiscal year during which the dividend is received may be
entitled to a deferral regime, and obtain a withholding tax refund. The tax deferral ends in respect of the first financial year during
which this US holder is in a profit making position, as well as in the cases set out in Article 235 quater of the French Tax Code. The
refund must be claimed within the same period applicable to claims related to taxes other than local taxes. Also, pursuant to
Article 235 quinquies of the French Tax Code and under certain conditions, a corporate US holder may be entitled to a refund of
a fraction of the withholding tax, up to the difference between the withholding tax paid (on a gross basis) and the withholding tax
based on the dividend net of the expenses incurred for the acquisition and conservation directly related to the income, provided
(i) that these expenses would have been tax deductible had the US holder been established in France, and (ii) that the tax rules in
the United States do not allow the US holder to offset the withholding tax.
Given the special features of the ADSs, US holders are urged to consult their own tax advisor about the possible application to
ADSs of such provisions in light of their own circumstances.
Tax on sale or other disposition
In general, under the Treaty, a US holder who is a US resident for purposes of the Treaty will not be subject to French tax on any
capital gain from the redemption (other than redemption proceeds characterized as dividends under French domestic law), sale
or exchange of ordinary shares or ADSs unless the ordinary shares or the ADSs form part of the business property of a permanent
establishment or fixed base that the US holder has in France. Special rules apply to holders who are residents of more than
one country.
US Taxes
Taxation of dividends
For US federal income tax purposes, the gross amount of any distribution paid to US holders (that is, the net distribution received
plus any tax withheld therefrom) will be treated as ordinary dividend income to the extent paid or deemed paid out of the current
or accumulated earnings and profits of Sanofi (as determined under US federal income tax principles). Dividends paid by Sanofi
will not be eligible for the dividends-received deduction generally allowed to corporate US holders.
Subject to certain exceptions for short-term and hedged positions, the US dollar amount of dividends received by an individual
US holder with respect to the ADSs or our ordinary shares is currently subject to taxation at a maximum rate of 20% if the
dividends are “qualified dividends”. Dividends paid on the ordinary shares or ADSs will be treated as qualified dividends if (i) the
issuer is eligible for the benefits of a comprehensive income tax treaty with the US that the Internal Revenue Service has
approved for the purposes of the qualified dividend rules and (ii) the issuer was not, in the year prior to the year in which the
dividend was paid, and is not, in the year in which the dividend is paid, a passive foreign investment company (PFIC). The Treaty
has been approved for the purposes of the qualified dividend rules. Based on our financial statements and relevant market and
shareholder data, we believe Sanofi was not a PFIC for US federal income tax purposes with respect to its 2024 taxable year. In
addition, based on its current expectations regarding the value and nature of its assets, the sources and nature of its income, and
relevant market and shareholder data, we do not anticipate that Sanofi will become a PFIC for its 2025 taxable year. Holders of
ordinary shares and ADSs should consult their own tax advisers regarding the availability of the reduced dividend tax rate in
light of their own particular circumstances.
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ITEM 10. Additional Information |
If you are a US holder, dividend income received by you with respect to ADSs or ordinary shares generally will be treated as
foreign source income for foreign tax credit purposes. The limitation on foreign taxes eligible for credit is calculated separately
with respect to specific classes of income. Distributions out of earnings and profits with respect to the ADSs or ordinary shares
generally will be treated as “passive category” income (or, in the case of certain US holders, “general category” income). Subject
to certain limitations and the Foreign Tax Credit Regulations (as defined below), French income tax withheld in connection with
any distribution with respect to the ADSs or ordinary shares may be claimed as a credit against the US federal income tax liability
of a US holder if such US holder elects for that year to credit all foreign income taxes. Alternatively, such French withholding tax
may be taken as a deduction against taxable income. Foreign tax credits will not be allowed for withholding taxes imposed in
respect of certain short-term or hedged positions in Securities and may not be allowed in respect of certain arrangements in
which a US holder’s expected economic profit is insubstantial. Further, certain Treasury regulations addressing foreign tax credits
(the "Foreign Tax Credit Regulations") impose additional requirements for foreign taxes to be eligible for a foreign tax credit if the
relevant taxpayer does not elect to apply the benefits of an applicable income tax treaty, and there can be no assurance that
those requirements will be satisfied. Recent notices from the Internal Revenue Service provide temporary relief by allowing
taxpayers that comply with applicable requirements to apply many aspects of the foreign tax credit regulations as they previously
existed (before the release of the current Foreign Tax Credit Regulations) for taxable years ending before the date that a notice
or other guidance withdrawing or modifying the temporary relief is issued (or any later date specified in such notice or other
guidance). The US federal income tax rules governing the availability and computation of foreign tax credits are complex.
US holders should consult their own tax advisers concerning the implications of these rules, including the Foreign Tax Credit
Regulations and the related temporary relief in the Internal Revenue Service notices, in light of their particular circumstances.
To the extent that an amount received by a US holder exceeds the allocable share of our current and accumulated earnings and
profits, such excess will be applied first to reduce such US holder’s tax basis in its ordinary shares or ADSs and then, to the extent
it exceeds the US holder’s tax basis, it will constitute capital gain from a deemed sale or exchange of such ordinary shares or ADSs
(see “— Tax on Sale or Other Disposition”, below).
The amount of any distribution paid in euros will be equal to the US dollar value of the euro amount distributed, calculated by
reference to the exchange rate in effect on the date the dividend is received by a US holder of ordinary shares (or by the
depositary, in the case of ADSs) regardless of whether the payment is in fact converted into US dollars on such date. US holders
should consult their own tax advisers regarding the treatment of foreign currency gain or loss, if any, on any euros received by a
US holder that are converted into US dollars on a date subsequent to receipt.
Distributions to holders of additional ordinary shares (or ADSs) with respect to their ordinary shares (or ADSs) that are made as
part of a pro rata distribution to all ordinary shareholders generally will not be subject to US federal income tax. However, if a
US holder has the option to receive a distribution in shares (or ADSs) or to receive cash in lieu of such shares (or ADSs), the
distribution of shares (or ADSs) will be taxable as if the holder had received an amount equal to the fair market value of the
distributed shares (or ADSs), and such holder’s tax basis in the distributed shares (or ADSs) will be equal to such amount.
Tax on sale or other disposition
In general, for US federal income tax purposes, a US holder that sells, exchanges or otherwise disposes of its ordinary shares
or ADSs will recognize capital gain or loss in an amount equal to the US dollar value of the difference between the amount realized
for the ordinary shares or ADSs and the US holder’s adjusted tax basis (determined in US dollars and under US federal income tax
rules) in the ordinary shares or ADSs. Such gain or loss generally will be US-source gain or loss, and will be treated as long-term
capital gain or loss if the US holder’s holding period in the ordinary shares or ADSs exceeds one year at the time of disposition. If
the US holder is an individual, any capital gain generally will be subject to US federal income tax at preferential rates (currently a
maximum of 20%) if specified minimum holding periods are met. The deductibility of capital losses is subject to significant
limitations.
Medicare tax
Certain US holders who are individuals, estates or trusts are required to pay a Medicare tax of 3.8% (in addition to taxes they
would otherwise be subject to) on their “net investment income” which would include, among other things, dividends and capital
gains from the ordinary shares and ADSs.
F. Dividends and Paying Agents
N/A
G. Statement by Experts
N/A
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PART I |
ITEM 10. Additional Information |
H. Documents on Display
We are subject to the information requirements of the US Securities Exchange Act of 1934, as amended, or Exchange Act, and,
in accordance therewith, we are required to file reports, including this annual report, and other information with the US Securities
and Exchange Commission, or Commission, by electronic means.
You may review a copy of our filings with the Commission, as well as other information furnished to the Commission, including
exhibits and schedules filed with it, at the Commission’s public reference room at 100 F Street, N.E., Washington, D.C. 20549.
Please call the SEC at 1-800-SEC-0330 for further information. In addition, the Commission maintains an Internet site at
http://www.sec.gov that contains reports and other information regarding issuers that file electronically with the Commission
(these documents are not incorporated by reference of this annual report).
I. Subsidiary Information
N/A.
J. Annual Report to Security Holders
To the extent we furnish an annual report to security holders, we will promptly submit an English version of this annual report to
US security holders under the cover of Form 6-K.
(1)The disclosures in this section supplement those provided in Note B.8.7. to the consolidated financial statements as regards the disclosure requirements
of IFRS 7, and are covered by the independent registered public accounting firms' opinion on the consolidated financial statements.
166 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 11. Quantitative and Qualitative Disclosures about Market Risk |
Item 11. Quantitative and Qualitative Disclosures about Market Risk(1)
General Policy
Liquidity risk, foreign exchange risk and interest rate risk, as well as related counterparty risks, are managed centrally by our
dedicated treasury team within the Group Finance Department. Where it is not possible to manage those risks centrally – in
particular due to regulatory restrictions (such as foreign exchange controls) or local tax restrictions – credit facilities and/or
currency lines, guaranteed whenever necessary by the parent company, are contracted by our subsidiaries locally with banks,
under the supervision of the central treasury team.
Our financing and investment strategies, and our interest rate and currency hedging strategies, are reviewed monthly by the
Group Finance Department.
Our policy prohibits the use of derivatives for speculative purposes.
Counterparty Risk
Our financing and investing transactions, and our currency and interest rate hedges, are contracted with leading counterparties.
We set limits for investment and derivative transactions with individual financial institutions, depending on the rating of each
institution. Compliance with these limits, which are based on the notional amounts of the investments and the fair value of the
hedging instruments, is monitored on a daily basis.
The table below shows our total exposure as of December 31, 2025 by rating and in terms of our percentage exposure to the
dominant counterparty.
(€ million) | Cash and cash equivalents (excluding mutual funds) | (a) | Notional amounts of currency hedges | (b) | Fair value of currency hedges | Notional amounts of interest rate hedges | (b) | Fair value of interest rate hedges | General corporate purpose credit facilities |
AA | 53 | 2,439 | (3) | 938 | (11) | 500 | |||
AA- | 110 | 12,032 | (16) | 682 | (12) | 1,500 | |||
A+ | 1,129 | 14,520 | (2) | 789 | (27) | 4,000 | |||
A | 477 | 8,964 | (2) | 795 | (29) | 2,000 | |||
A- | — | — | — | — | — | — | |||
Unallocated | 68 | — | — | — | — | — | |||
Total | 1,837 | 37,954 | (23) | 3,204 | (79) | 8,000 | |||
%/rating of dominant counterparty | 21.5% / A+ | 11.3% /AA- | 29.3% /AA | 6% /A+ |
(a)Cash equivalents include mutual fund investments of €5,820 million.
(b)The notional amounts are translated into euros at the relevant closing exchange rate as of December 31, 2025.
As of December 31, 2025, Sanofi held investments in euro and US dollar denominated money-market mutual funds. Those
instruments have low volatility, low sensitivity to interest rate risk, and a very low probability of loss of principal. The depositary
banks of the mutual funds, and of Sanofi itself, have a long-term rating of at least A. Realization of counterparty risk could impact
our liquidity in certain circumstances.
Foreign Exchange Risk
A. Operating foreign exchange risk
A substantial portion of our net sales is generated in countries where the euro, which is our reporting currency, is not the
functional currency. In 2025, for example, 50.8% of our net sales were generated in the US; 21.0% in Europe; and 28.2% in the
Rest of the World region (see the definition in “Item 5. Operating and Financial Review and Prospects — A. Operating results),
including countries that are, or may in the future become, subject to exchange controls, of which 6.0% was generated in China
and 3.2% in Japan. Although we also incur expenses in those countries, the impact of those expenses is not enough wholly to
offset the impact of exchange rates on our net sales. Consequently, our operating income may be materially affected by
fluctuations in exchange rates between the euro and other currencies. Sanofi operates a foreign exchange risk hedging policy to
reduce the exposure of operating income to exchange rate movements. That policy involves regular assessments of Sanofi’s
worldwide foreign currency exposure, based on foreign currency transactions carried out by the parent company and its
subsidiaries. Those transactions mainly comprise sales, purchases, research costs, co-marketing and co-promotion expenses, and
royalties. To reduce the exposure of those transactions to exchange rate movements, Sanofi contracts hedges using liquid
derivative instruments, mainly forward currency purchases and sales, and also foreign exchange swaps. See also “Item 5.
Operating and Financial Review and Prospects — A. Operating results — A.1.8 Impact of Exchange Rates.”
The table below shows operating currency hedging instruments in place as of December 31, 2025, with the notional amount
translated into euros at the relevant closing exchange rate (see Note D.20. to our consolidated financial statements included at
Item 18. of this annual report, for the accounting classification of those instruments as of December 31, 2025).
SANOFI FORM 20-F 2025 | 167 |
PART I |
ITEM 11. Quantitative and Qualitative Disclosures about Market Risk |
Operating foreign exchange derivatives as of December 31, 2025
(€ million) | Notional amount | Fair value |
Forward currency sales | 9,202 | (12) |
of which US dollar | 4,552 | 7 |
of which Singapore dollar | 1,093 | 1 |
of which Chinese yuan renminbi | 897 | (4) |
of which Saudi Arabian riyal | 273 | 2 |
of which Turkish lira | 224 | (11) |
Forward currency purchases | 7,686 | (16) |
of which US dollar | 4,224 | (27) |
of which Singapore dollar | 1,204 | (1) |
of which Chinese yuan renminbi | 718 | 3 |
of which Turkish lira | 212 | 7 |
of which Hungarian forint | 163 | 1 |
Total | 16,888 | (28) |
The above positions mainly hedge future material foreign-currency cash flows arising after the end of the reporting period in
relation to transactions carried out during the year ended December 31, 2025 and recognized in the balance sheet at that date.
Gains and losses on hedging instruments (forward contracts) are calculated and recognized in parallel with the recognition of
gains and losses on the hedged items. Due to this hedging relationship, the commercial foreign exchange profit or loss on these
items (hedging instruments and hedged transactions) will be immaterial in 2026.
B. Financial foreign exchange risk
The cash pooling arrangements for foreign subsidiaries outside the euro zone, and some of Sanofi’s financing activities, expose
certain Sanofi entities to financial foreign exchange risk (i.e. the risk of changes in the value of borrowings and loans denominated
in a currency other than the functional currency of the borrower or lender). That foreign exchange exposure is hedged using
derivative instruments (foreign exchange swaps, forward contracts or cross currency swaps) that alter the currency split of
Sanofi’s net debt once those instruments are taken into account.
The table below shows financial currency hedging instruments in place as of December 31, 2025, with the notional amounts
translated into euros at the relevant closing exchange rate (see also Note D.20. to our consolidated financial statements included
at Item 18. of this annual report, for the accounting classification of these instruments as of December 31, 2025).
Financial foreign exchange derivatives as of December 31, 2025
(€ million) | Notional amount | Fair value | Expiry | |
Cross currency seller swaps | 1,481 | 6 | ||
of which US dollar | 1,481 | (a) | 6 | 2032 |
Forward currency sales | 12,550 | (13) | ||
of which US dollar | 10,323 | (b) | 2027 | |
of which Pound sterling | 981 | (8) | 2026 | |
of which Japanese yen | 294 | 3 | 2026 | |
Forward currency purchases | 7,035 | 12 | ||
of which US dollar | 4,055 | (c) | 1 | 2026 |
of which Singapore dollar | 1,041 | (5) | 2026 | |
of which Hungarian forint | 719 | 9 | 2026 | |
Total | 21,066 | 5 |
(a)Comprises two cross currency swaps (i) with a notional amount of $870 million, pay 4.16% in US dollars and receive 2.50% in euros expiring 2029 and (ii)
with a notional amount of $870 million, pay 4.53% in US dollars and receive 3.00% in euros, expiring 2032, designated as a hedge of Sanofi’s net
investment in the US. As of December 31, 2025, the fair value of the swaps was an asset of €6 million, with €9 million credited to Other comprehensive
income and €3 million debited to financial income and expenses.
(b)Includes forward sales with a notional amount of $11,275 million expiring in 2026 and 2027, designated as a hedge of Sanofi’s net investment in the US.
As of December 31, 2025, the fair value of these forward contracts represented a liability of €30 million, of which €30 million debited to Other
comprehensive income, with the impact on financial income and expenses being immaterial.
(c)Includes forward purchases with a notional amount of $1,000 million expiring in 2026, designated as a fair value hedge of the exposure of $1,000 million
of bond issues to fluctuations in the EUR/USD spot rate. As of December 31, 2025, the fair value of the contracts was an asset of €3 million, of which
€1 million was credited to Other comprehensive income under the cost of hedging accounting treatment.
These hedging instruments generate a net financial gain or loss arising from the interest rate differential between the hedged
currency and the euro, given that the foreign exchange gain or loss on the foreign-currency borrowing and loans is offset by the
change in the intrinsic value of the hedging instruments. The interest rate differential is recognized within cost of net debt
(see Note D.29. to our consolidated financial statements included at Item 18. of this annual report). We may also hedge some
future foreign-currency investment or divestment cash flows.
168 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 11. Quantitative and Qualitative Disclosures about Market Risk |
C. Other foreign exchange risks
A significant proportion of our net assets is denominated in US dollars (see Note D.35. to the consolidated financial statements
included at Item 18. of this annual report). As a result, any fluctuation in the exchange rate of the US dollar against the euro
automatically impacts the amount of our equity as expressed in euros; however, the impact is partially hedged by transactions
designated as hedges of Sanofi’s net investment in the US (see "B.— Financial foreign exchange risk" above, and Note D17.1. to
the consolidated financial statements included at Item 18. of this annual report).
In addition, we use the euro as our reporting currency. Consequently, if one or more EU Member States were to abandon the euro
as a currency, the resulting economic upheavals – in particular, fluctuations in exchange rates – could have a significant impact
on the terms under which we can obtain financing and on our financial results, the extent and consequences of which are not
currently foreseeable.
Liquidity Risk
We operate a centralized treasury platform whereby all surplus cash and financing needs of our subsidiaries are invested with or
funded by the parent company (where permitted by local legislation). The central treasury department manages our current and
projected financing, and ensures that Sanofi is able to meet its financial commitments by maintaining sufficient cash and
confirmed credit facilities for the size of our operations and the maturity of our debt (see Notes D.17.1.c. and D.17.1.g. to the
consolidated financial statements included at Item 18. of this annual report).
We diversify our short-term investments with leading counterparties using money-market products with instant access, or with a
maturity of most often less than three months.
As of December 31, 2025, cash and cash equivalents amounted to €7,657 million, and short-term investments predominantly comprised:
•collective investments in euro and US dollar denominated money-market mutual funds. All such funds can be traded on a daily
basis and the amount invested in each fund may not exceed 10% of each fund's net asset value ; and
•amounts invested directly with banks in the form of instant access deposits, and term deposits with a maturity of no more than
three months.
As of December 31, 2025, we also had €8 billion of undrawn general corporate purpose confirmed credit facilities, half of which
expires in December 2027 and half in March 2030. Those credit facilities are not subject to financial covenant ratios.
Our policy is to diversify our sources of funding through public or private issuances of debt securities, in the US (shelf registration
statement) and Europe (Euro Medium Term Note program). In addition, our A-1+/P-1/S-1+ (by Standard & Poor’s/Moody’s/Scope
Ratings respectively) short-term rating gives us access to commercial paper programs in the US, and to Negotiable European
Commercial Paper programs in France. The average maturity of our total debt was 3.58 years as of December 31, 2025,
compared with 3.56 years as of December 31, 2024.
Average drawdowns under the Negotiable European Commercial Paper program in France during 2025 were €0.1 billion (with a
maximum of €0.2 billion); the average maturity of those drawdowns was three months. As of December 31, 2025, this program
was not being utilized.
Average drawdowns under the US Commercial Paper program during 2025 were $3.8 billion (with a maximum of $6.8 billion);
the average maturity of those drawdowns was two months. As of December 31, 2025, drawdowns under the program amounted
to $1.0 billion.
In the event of a liquidity crisis, we could be exposed to difficulties in calling up our available cash, a scarcity of sources of funding
including the above-mentioned programs, and/or a deterioration in their terms. This situation could damage our capacity to
refinance our debt or to issue new debt on reasonable terms.
Interest Rate Risk
Sanofi issues debt in two currencies, the euro and the US dollar, and also invests its cash and cash equivalents in those currencies.
Sanofi also operates cash pooling arrangements to manage the surplus cash and short-term liquidity needs of foreign subsidiaries
located outside the euro zone.
To optimize the cost of debt or reduce the volatility of debt and manage its exposure to financial foreign exchange risk, Sanofi
uses derivative instruments (interest rate swaps, currency swaps, foreign exchange swaps and forward contracts) that alter the
fixed/floating rate split and the currency split of its net debt.
The projected full-year sensitivity to interest rate fluctuations of our debt, net of cash and cash equivalents for 2026 is as follows:
Change in short-term interest rates | Impact on pre-tax net income (€ million) | Impact on pre-tax income/(expense) recognized directly in equity (€ million) |
+100 bp | 50 | 27 |
+25 bp | 12 | 7 |
-25 bp | (12) | (7) |
-100 bp | (50) | (27) |
Stock Market Risk
It is our policy not to trade on the stock market for speculative purposes.
SANOFI FORM 20-F 2025 | 169 |
PART I |
ITEM 12. Description of Securities other than Equity Securities |
Item 12. Description of Securities other than Equity Securities
12.A. Debt securities
Not applicable.
12.B. Warrants and rights
Not applicable.
12.C. Other securities
Not applicable.
12.D. American depositary shares
General
JPMorgan Chase Bank, NA (“JPMorgan”), as depositary, issues Sanofi ADSs in certificated form (evidenced by an ADR) or book-
entry form. Each ADR is a certificate evidencing a specific number of Sanofi ADSs. Each Sanofi ADS represents one-half of one
Sanofi ordinary share (or the right to receive one-half of one Sanofi ordinary share) deposited with the Paris, France office of BNP
Paribas, as custodian. Each Sanofi ADS also represents an interest in any other securities, cash or other property that may
be held by the depositary under the Second Amended and Restated Deposit Agreement between Sanofi and JPMorgan
dated February 13, 2015, as amended by Amendment No. 1 dated July 23, 2020 (“Amendment No. 1”), Amendment No. 2
dated December 18, 2023 ("Amendment No. 2"), and as may be further amended from time to time (together, the “deposit
agreement”). The depositary’s principal executive office is located at 383 Madison Avenue, 11th Floor, New York, New York 10179.
For additional information on our ADSs, please refer to Exhibit 2.2 “Description of securities registered under section 12 of the
Exchange Act.” of this Annual Report.
Fees and expenses
Fees payable by ADS holders
Pursuant to the deposit agreement, holders of our ADSs may have to pay to JPMorgan, either directly or indirectly, fees, charges
and expenses up to the amounts set forth in the table below.
Associated Fee | Depositary Action |
$5.00 or less per 100 ADSs (or portion thereof) | The deposit of shares and/or the execution and delivery of ADRs (pursuant to distribution in shares or distribution of rights to subscribe for additional shares, or distribution of any rights of any other nature), and/or the reduction of ADSs and surrender of ADRs for the purposes of withdrawal, including the termination of the deposit agreement. |
$0.05 or less per ADS (or portion thereof) | Any distribution made pursuant to the deposit agreement, including, among other things: •any cash distribution made, or for any elective cash/stock dividend offered; and •the direct or indirect distribution of securities (other than ADSs or rights to purchase additional ADSs) or the net cash proceeds from the public or private sale of any such securities. |
$0.05 or less per ADS per calendar year (or portion thereof) | Services performed in administering the ADRs (which fee may be charged on a periodic basis during each calendar year). |
An amount for the reimbursement of such fees, charges and expenses as are incurred by JPMorgan and/or any of its agents (including, without limitation BNP Paribas, as custodian and expenses incurred on behalf of owners in connection with compliance with foreign exchange control regulations or any law or regulation relating to foreign investment) | Compliance with foreign exchange control regulations or any law or regulation relating to foreign investment, servicing of shares or other deposited securities, sale of securities, delivery of deposited securities or otherwise. |
Expenses incurred by JPMorgan | Foreign currency conversion into dollars. |
The Depositary may sell (by public or private sale) sufficient securities and property received in respect of Share distributions,
rights and other distributions prior to a deposit to pay any charge owing.
In addition to the fees outlined above, each holder will be responsible for any taxes or other governmental charges payable on his
or her Sanofi ADSs or on the deposited securities underlying his or her Sanofi ADSs. The depositary may refuse to transfer a
holder’s Sanofi ADSs or allow a holder to withdraw the deposited securities underlying his or her Sanofi ADSs until such taxes or
other charges are paid. It may apply payments owed to a holder or sell deposited securities underlying a holder’s Sanofi ADSs to
pay any taxes owed, and the holder will remain liable for any deficiency. If it sells deposited securities, it will, if appropriate, reduce
the number of Sanofi ADSs to reflect the sale and pay to the holder any proceeds, or send to the holder any property, remaining
after it has paid the taxes. For additional information regarding taxation, see “Item 10. Additional Information — E. Taxation.”
170 | SANOFI FORM 20-F 2025 |
PART I |
ITEM 12. Description of Securities other than Equity Securities |
Fees paid to Sanofi by the depositary
JPMorgan, as depositary, has agreed to reimburse Sanofi for certain expenses that Sanofi incurs relating to the establishment and
maintenance of the ADR program, as agreed from time to time. Pursuant to a letter agreement dated October 4, 2022 (the “letter
agreement”), JPMorgan as our ADS depositary has agreed to make (i) an initial contribution to Sanofi, within 30 days of the
commencement date of the letter agreement and (ii) with respect to each 12-month period beginning on the anniversary of the
effective date of the agreement (each such 12-month period, a “Contract Year”), a contribution, paid at the end of such Contract
Year quarter, equal to the aggregate of the program share (equal to 100% of routine program revenues and 50% of non-routine
program revenues) of any program revenues, less the aggregate of any program costs for the applicable Contract Year and any
invoiced supplementary costs not paid within 60 days of the date of the applicable invoice.
To the extent in any given Contract Year the depositary does not collect/recoup the entirety of the program costs and unpaid
supplementary costs, no contribution shall be payable to Sanofi and such excess will, at the discretion of the depositary, either be
deducted from future contributions or be payable to the depositary by Sanofi promptly upon invoicing as supplementary costs
under the letter agreement.
JPMorgan has further agreed to waive the $0.05 per ADS issuance fees that would normally be owed by Sanofi in connection
with our deposits of shares as part of our employee stock purchase plans. Sanofi is responsible for reimbursing JPMorgan for all
taxes and governmental charges in connection with payments to JPMorgan under the letter agreement.
From January 1, 2025 to December 31, 2025, we received a total amount of $23,930,596.45 from JPMorgan pursuant to the letter
agreement.
SANOFI FORM 20-F 2025 | 171 |
PART II |
ITEM 13. Defaults, Dividend Arrearages and Delinquencies |
Part II
Item 13. Defaults, Dividend Arrearages and Delinquencies
N/A
Item 14. Material Modifications to the Rights of Security Holders
N/A
172 | SANOFI FORM 20-F 2025 |
PART II |
Item 15. Controls and Procedures |
Item 15. Controls and Procedures
A. Disclosure Controls and Procedures
Our Chief Executive Officer and Principal Financial Officer, after evaluating the effectiveness of our disclosure controls and
procedures (as defined in Exchange Act Rule 13a-15(e)) as of the end of the period covered by this Form 20-F, have concluded
that, as of such date, our disclosure controls and procedures were effective to ensure that material information relating to Sanofi
was timely made known to them by others within Sanofi.
B. Management’s Annual Report on Internal Control over Financial Reporting
The management of the Company is responsible for establishing and maintaining adequate internal control over financial
reporting, as such term is defined in Exchange Act Rule 13a-15(f). Management assessed the effectiveness of internal control over
financial reporting as of December 31, 2025 based on the framework in “Internal Control — Integrated
Framework” (2013 framework) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
Blueprint Medicines (Blueprint Medicines Corporation and its affiliates), acquired in 2025, has been excluded from the scope of
management’s assessment and conclusion on internal control over financial reporting as of December 31, 2025. Blueprint is
included in the 2025 consolidated financial statements of the Company; it represents less than 1% of total assets as of December
31, 2025 and less than 1% of net sales for the year then ended.
Based on that assessment, management has concluded that the Company’s internal control over financial reporting was
effective as of December 31, 2025 to provide reasonable assurance regarding the reliability of its financial reporting and the
preparation of its financial statements for external purposes, in accordance with generally accepted accounting principles.
Due to its inherent limitations, internal control over financial reporting may not prevent or detect misstatements, and can only
provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements. Also,
projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate
because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
The effectiveness of the Company’s internal control over financial reporting has been audited by PricewaterhouseCoopers Audit
(PCAOB ID 1347 ) and Forvis Mazars SA (PCAOB ID 1334 ) independent registered public accounting firms, as stated in their report
on the Company’s internal control over financial reporting as of December 31, 2025, which is included herein. See paragraph (c) of
the present Item 15., below.
C. Attestation Report of the Registered Public Accounting Firm
The effectiveness of the Company's internal control over financial reporting as of December 31, 2025 has been audited by
PricewaterhouseCoopers Audit and Forvis Mazars SA , independent registered public accounting firms. See their report included
under “Item 18. Financial Statements” on page 181.
D. Changes in Internal Control over Financial Reporting
There were no changes to the Company's internal control over financial reporting that occurred during the period covered by this
Form 20-F that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
SANOFI FORM 20-F 2025 | 173 |
PART II |
ITEM 16A. Audit Committee Financial Expert |
Item 16A. Audit Committee Financial Expert
The Audit Committee is composed of Carole Ferrand, Clotilde Delbos, Christophe Babule, and Anne-Françoise Nesmes.
Our Board of Directors has determined that all directors are independent financial experts within the meaning of Section 407 of
the Sarbanes-Oxley Act of 2002.
The Board of Directors deemed Carole Ferrand to be a financial expert based on her education and experience in audit at
PricewaterhouseCoopers, as Financing Operations Director of Groupe Artémis and as Chief Financial Officer of Sony France,
EuropaCorp and Capgemini. She is now Head of Strategy and Development of Motier Holding.
The Board of Directors deemed Clotilde Delbos to be a financial expert based on her education and experience in Audit, Mergers
& Acquisitions and Treasury, including at PricewaterhouseCoopers and Pechiney. She has also been Chief Financial Officer of
Renault Group for six years.
The Board of Directors deemed Christophe Babule to be a financial expert based on his education and experience in audit and
corporate finance in major corporations and as Executive Vice President and Chief Financial Officer of L’Oréal. He has also served
as a director of L’Oréal US Inc.
The Board of Directors deemed Anne-Françoise Nesmes to be a financial expert based on her education and experience as a
Chief Financial Officer of several listed companies: Dechra Pharmaceuticals PLC, Merlin Entertainments PLC, and
Smith & Nephew PLC. She was Chief Financial Officer of Smith & Nephew PLC until the end of 2024.
The Board of Directors has determined that all four directors meet the independence criteria of Rule 10A-3 under the Exchange
Act, although only Carole Ferrand, Clotilde Delbos, and Anne-Françoise Nesmes meet the French AFEP-MEDEF Code criteria of
independence applied by the Board of Directors for general corporate governance purposes (see "Item 16G. Corporate
Governance" below).
Item 16B. Code of Ethics
We have adopted a code of ethics (hereafter the "Code of Conduct"), as defined in Item 16B. of Form 20-F under the Exchange
Act, containing specific rules relating to financial ethics. Our Code of Conduct applies to our Chief Executive Officer, Chief
Financial Officer, Chief Accounting Officer and other officers performing similar functions, as designated from time to time. Our
Code of Conduct was amended on September 29, 2025 and this amended version is available on our website at www.sanofi.com
(information on our website is not incorporated by reference of this annual report). The main changes consisted in the addition of
a new chapter on health and safety, and in strengthening commitments regarding inclusion, environmental protection and
intellectual property protection. A copy of our Code of Conduct may also be obtained free of charge by addressing a written
request to the attention of Individual Shareholder Relations at our headquarters in Paris. We will disclose any future amendments
to the provisions of such financial Code of Conduct on our website.
Item 16C. Principal Accountants’ Fees and Services
The Audit Committee has adopted an Audit and Non-Audit Services Pre-Approval Policy that sets forth the procedures and the
conditions pursuant to which services proposed to be performed by the statutory auditors may be pre-approved and that are not
prohibited by regulatory or other professional requirements. This policy provides for pre-approval of certain types of services
through the use of an annual budget approved by the Audit Committee for these types of services. The Audit Committee reviews
on an annual basis the services provided by the statutory auditors.
See Note E. to our consolidated financial statements included at Item 18. of this annual report.
Item 16D. Exemptions from the Listing Standards for Audit
Committees
N/A
174 | SANOFI FORM 20-F 2025 |
PART II |
ITEM 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers |
Item 16E. Purchases of Equity Securities by the Issuer and Affiliated
Purchasers
In 2025, Sanofi made the following purchases of its ordinary shares.
Period | (A) Total Number of Shares Purchased | (B) Average Price Paid per Share | (C) Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs(b) | (D) Approximate Value of Shares that May Yet Be Purchased Under the Plans or Programs(c) |
January 2025 | — | n/a | — | 18,972 |
February 2025(a) | 32,444,976 | 101.71 | 32,444,976 | 15,672 |
March 2025 | 2,821,680 | 106.32 | 2,821,680 | 15,372 |
April 2025 | 3,221,338 | 93.13 | 3,221,338 | 15,072 |
May 2025 | 423,109 | 94.54 | 423,109 | 21,433 |
June 2025 | 469,160 | 85.26 | 469,160 | 21,393 |
July 2025 | 479,363 | 83.44 | 479,363 | 21,353 |
August 2025 | 477,425 | 83.78 | 477,425 | 21,313 |
September 2025 | 498,484 | 80.24 | 498,484 | 21,273 |
October 2025 | 3,490,676 | 85.94 | 3,490,676 | 20,973 |
November 2025 | 3,444,999 | 87.08 | 3,444,999 | 20,673 |
December 2025 | 3,609,718 | 83.11 | 3,609,718 | 20,373 |
Total | 51,380,928 | 97.31 | 51,380,928 |
(a)On February 2, 2025, Sanofi and L'Oréal entered into a share purchase agreement pursuant to which Sanofi repurchased 29,556,650 shares from
L’Oréal, a significant shareholder, at €101.50 per share, for a total amount of approximately €3 billion. Following the repurchase, and after cancellation
on March 13, 2025 of said shares, as of December 31, 2025 L’Oréal held 7.27% of Sanofi’s share capital and 13.10% of Sanofi’s effective voting rights
(excluding treasury shares). For more information, see "Item 8. Financial Information - B. Significant Changes".
(b)Sanofi was authorized to repurchase up to €18,971,999,400 of its own shares for a period of eighteen months (i.e. through October 30, 2025) by the
Annual Shareholders’ Meeting held on April 30, 2024. Sanofi was subsequently authorized to repurchase up to €21,473,086,240 of its own shares for a
period of eighteen months (i.e. through October 30, 2026) by the Annual Shareholders’ Meeting held on April 30, 2025.
(c)Millions of euros.
For more information see Exhibit 2.2. "Description of securities registered under section 12 of the Exchange Act." of this annual
report.
Item 16F. Change in Registrant’s Certifying Accountant
Forvis Mazars SA was appointed as joint statutory auditor for a six-year term by the annual shareholders’ meeting held on April 30,
2024. The term of office of Forvis Mazars SA will expire at the end of the annual shareholders’ meeting to be held in 2030, which
will approve the financial statements for 2029. This appointment follows the Audit Committee’s recommendation and the
decision of the Board of Directors taken on October 27, 2022.
The term of office of Ernst & Young et Autres expired at the 2024 Annual Shareholders’ Meeting and could not be renewed
because it had reached the maximum legal duration. The report of Ernst & Young et Autres on the consolidated financial
statements for each of the years ended December 31, 2023 and 2022 did not contain an adverse opinion or a disclaimer of
opinion and was not qualified or modified as to uncertainty, audit scope or accounting principles and there were no
“disagreements” (as that term is described in Item 16F.(a)(1)(iv) of the Instructions to Form 20-F and the Instructions to Item 16F.)
or “reportable events” (as that term is defined in Item 16F.(a)(1)(v) of the Instructions to Form 20-F) during those periods.
A copy of Ernst & Young et Autres’ letter, dated February 23, 2024, was filed as Exhibit 15.3 to the annual report on Form 20-F for
the year ended December 31, 2023, filed on February 23, 2024.
SANOFI FORM 20-F 2025 | 175 |
PART II |
Item 16G. Corporate Governance |
Item 16G. Corporate Governance
Sanofi is incorporated under the laws of France, with securities listed on regulated public markets in the United States (Nasdaq
Global Select Market – NASDAQ) and France (Euronext Paris). Consequently, as described further in this annual report, our
corporate governance framework reflects the mandatory provisions of French corporate law, the securities laws and regulations
of France and the United States and the rules of the aforementioned public markets.
As a “foreign private issuer”, as defined in the rules promulgated under the Exchange Act, Sanofi is permitted, pursuant to
NASDAQ Listing Rule 5615(a)(3), to follow its home country practice in lieu of certain NASDAQ corporate governance
requirements applicable to US corporations listed on the NASDAQ. Sanofi has informed NASDAQ that it intends to follow
corporate governance standards under French law to the extent permitted by the NASDAQ listing rules and US securities laws, as
further discussed below.
We generally follow the “AFEP-MEDEF” corporate governance recommendations for French listed issuers (hereafter referred to
as the “AFEP-MEDEF Code”). As a result, our corporate governance framework is similar in many respects to, and provides
investor protections that are comparable to – or in some cases, more stringent than – the corresponding rules of the NASDAQ.
Nevertheless, there are certain important differences.
In line with NASDAQ listing rules applicable to domestic issuers, a majority of Sanofi’s Board of Directors is comprised of
independent directors. Sanofi evaluates the independence of members of our Board of Directors using the standards of the
French AFEP-MEDEF Code as the principal reference. We believe that AFEP-MEDEF’s overarching criteria for independence –
that Board members have no relationship of any kind whatsoever with the Company, its group or the management of either such
as to color a Board member’s judgment – is on the whole consistent with the goals of the NASDAQ's listing rules; however, the
specific tests proposed under the two standards may vary on some points. Our Audit Committee complies with
the independence and other requirements of Rule 10A-3 under the Exchange Act, adopted pursuant to the Sarbanes-Oxley
Act of 2002. Our Audit Committee includes one member, Christophe Babule, who is considered non-independent under the
AFEP-MEDEF Code, and which is permitted under the AFEP-MEDEF Code. Three out of the four members of our Compensation
Committee meet the independence standards of the AFEP-MEDEF Code (the Director representing employees is not
considered as independent) and the independence requirements of NASDAQ’s listing rules.
Sanofi follows the recommendation of the AFEP-MEDEF Code that at least one meeting of the Board of Directors not attended
by the company’s executive officers be organized each year. Accordingly, Sanofi’s Board Charter provides that the Board of
Directors shall organize at least two meetings a year without its executive officers, thereby providing the Chairman with the
option of whether to include directors representing employees or any other Group employee, as the case may require,
depending on the agenda of the meeting. Sanofi’s practice in that respect departs from NASDAQ Listing Rule 5605(b)(2), which
provides that independent directors must have regularly scheduled meetings at which only independent directors are present.
Under French law, the committees of our Board of Directors are advisory only, and where the NASDAQ Listing Rule 5600 series
would vest certain decision-making powers with specific committees by delegation (e.g. the appointment of Sanofi’s auditors by
the Audit Committee), under French law, our Board of Directors remains the only competent body to take such decisions, albeit
taking into account the recommendation of the relevant committees. Additionally, under French corporate law, it is the
shareholders of Sanofi voting at the Shareholders’ General Meeting that have the authority to appoint our auditors upon
consideration of the proposal of our Board of Directors, although our Board Charter provides that the Board of Directors will
make its proposal on the basis of the recommendation of our Audit Committee. We believe that this requirement of French law,
together with the additional legal requirement that two sets of statutory auditors be appointed, is in line with the NASDAQ's
underlying goal of ensuring that the audit of our accounts be conducted by auditors independent from company management.
NASDAQ Listing Rule 5635 requires a NASDAQ listed company to obtain shareholder approval prior to certain issuances of
securities, including: (a) issuances in connection with the acquisition of the stock or assets of another company if upon issuance
the issued shares will equal 20% or more of the number of shares or voting power outstanding prior to the issuance, or if certain
specified persons have a 5% or greater interest in the assets or company to be acquired (NASDAQ Listing Rule 5635(a));
(b) issuances or potential issuances that will result in a change of control of us (NASDAQ Listing Rule 5635(b)); (c) issuances in
connection with equity compensation arrangements (NASDAQ Listing Rule 5635(c)); and (d) 20% or greater issuances in
transactions other than public offerings, as defined in the NASDAQ listing rules (NASDAQ Listing Rule 5635(d)). Under French
law, our shareholders may approve issuances of equity, as a general matter, through the adoption of delegation of authority
resolutions at the Company’s shareholders’ meeting pursuant to which shareholders may delegate their authority to the Board
of Directors to increase the Company’s share capital within specified parameters set by the shareholders, which may include a
time limitation to carry out the share capital increase, the cancellation of their preferential subscription rights to the benefit of
named persons or a category of persons, specified price limitations and/or specific or aggregate limitations on the size of the
share capital increase. Due to differences between French law and corporate governance practices and NASDAQ Listing
Rule 5635, the Company follows French home country practice, rather than complying with this NASDAQ Listing Rule.
In addition to the oversight role of our Compensation Committee for questions of management compensation including by way
of equity, under French law any option or restricted share plans or other share capital increases, whether for the benefit of senior
management or employees, may only be adopted by the Board of Directors pursuant to and within the limits of a shareholder
resolution approving the related capital increase and delegating to the Board the authority to implement such operations. While
NASDAQ rules require shareholder approval when a plan or other equity compensation arrangement is established or materially
amended, under French law our shareholders must decide any issuance of equity, as a general matter. We intend to follow our
French home country practice and ask our shareholders to delegate their authority to issue incentive equity and define the final
176 | SANOFI FORM 20-F 2025 |
PART II |
Item 16G. Corporate Governance |
terms of any equity compensation plan or arrangements to our Board of Directors. We may, from time to time, ask for our
shareholders’ subsequent approval on an equity compensation arrangement in order to obtain advantageous tax treatment or
otherwise. In addition, under French law, our Board of Directors must obtain the prior approval of our shareholders before
establishing or amending a plan or arrangement that would exceed the limits of the granted delegation.
As described above, a number of issues, which could be resolved directly by a board or its committees in the United States,
require the additional protection of direct shareholder consultation in France.
Because we are a “foreign private issuer” as described above, our Chief Executive Officer and our Chief Financial Officer issue
the certifications required by Section 302 and Section 906 of the Sarbanes-Oxley Act of 2002 on an annual basis (with the filing
of our annual report) rather than on a quarterly basis as would be the case of a US corporation filing quarterly reports on
Form 10- Q.
French corporate law provides that the Board of Directors must vote to approve a broadly defined range of transactions that
could potentially create conflicts of interest between Sanofi on the one hand and its directors and Chief Executive Officer on
the other hand, which are then presented to shareholders for approval at the next annual meeting. This legal safeguard
operates in place of certain provisions of the NASDAQ listing rules.
Sanofi is governed by the French Commercial Code, which provides that an ordinary general meeting of the shareholders may
validly deliberate when first convened if the shareholders present or represented hold at least one-fifth of the voting shares.
If it is reconvened, no quorum is required. The French Commercial Code further provides that the shareholders at an
extraordinary general meeting may validly deliberate when first convened only if the shareholders present or represented hold
at least one-quarter of the voting shares and, if reconvened, one-fifth of the voting shares. Therefore, Sanofi will not follow
NASDAQ Listing Rule 5620(c), which provides that the minimum quorum requirement for a meeting of shareholders is 331⁄3% of
the outstanding common voting shares of the company. In accordance with the provisions of the French Commercial Code, the
required majority for the adoption of a decision is a simple majority (for an ordinary general meeting of the shareholders) or a
two-thirds majority (for an extraordinary general meeting) of the votes cast by the shareholders present or represented.
The Company has, pursuant to Rule 10D-1 under the Exchange Act, adopted a recovery policy for compensation erroneously
paid to “executive officers” (as defined in Rule 10D-1(d) under the Exchange Act) based in whole or in part on any financial
reporting measures pursuant to the applicable NASDAQ listing rules, Rule 10D-1 under the Exchange Act and applicable
interpretive guidance. For more information concerning our recovery policy for compensation erroneously paid to “executive
officers”, see also “Item 6. Directors, Senior Management and Employees – B. Compensation”. Our recovery policy for
compensation erroneously paid to “executive officers” is incorporated by reference to Exhibit 97 of the Company’s Annual
Report on Form 20-F for the year ended December 31, 2023.
Item 16H. Mine Safety Disclosure
N/A
Item 16I. Disclosure regarding foreign jurisdictions that prevent
inspections
N/A
Item 16J. Insider Trading Policies
Sanofi has adopted a Global Operating Procedure on the Prevention of Insider Trading governing the purchase, sale, and other
dispositions of securities by directors, senior management, and employees that is reasonably designed to promote compliance
with applicable insider trading laws, rules and regulations, and any applicable listing standards. A copy of the policy is included as
Exhibit 11.1. to this annual report.
SANOFI FORM 20-F 2025 | 177 |
PART II |
ITEM 16K. Cybersecurity |
Item 16K. Cybersecurity
Sanofi has implemented a cybersecurity strategy involving various dedicated personnel and resources aimed at preventing,
detecting and responding to cyberattacks, as well as being able to recover promptly in the event of material impact following a
cyberattack. Additionally, Sanofi has set up various cybersecurity processes applicable to subsidiaries within the Sanofi group.
Sanofi regularly updates its cybersecurity processes to address cybersecurity trends and threats. Cybersecurity processes have
been established to address material cybersecurity risks, including in connection with the following areas:
•information technology and solution usage;
•access control;
•patch management;
•security on specific environments (i.e. cloud, virtualization, SAP, automated systems, IoT, etc.);
•log management;
•network security;
•systems security standards;
•remote access;
•secure development of applications;
•cryptography;
•mobile devices;
•third-party management (including cybersecurity requirements in contracts); and
•incident management.
Sanofi utilizes security standards and frameworks (i.e. the NIST framework) and has established cross-functional risk control
capabilities to facilitate operational implementation aligned with its cybersecurity processes.
Sanofi regularly analyzes its Internet-based services and performs regular penetration tests and attack simulations to assess the
protection and detection capabilities. The cybersecurity compliance status of computing assets connected to Sanofi’s network is
routinely consolidated for Sanofi's business units, including within manufacturing, and research and development sites. Monthly
dashboards are published and shared within Sanofi’s different business units and global functions. Sanofi implements corrective
measures and improvement actions in response to these processes. Data classification and protection tools are in place, such as
the implementation of a specific process and technology aimed at detecting and responding to abnormal data flows.
well as coordinating Sanofi-wide incident responses. Incident response trainings and simulations are run within Sanofi to seek to
be better prepared in case of a cybersecurity incident. In addition, Sanofi’s employees, who are the main users of Sanofi’s digital
assets, are regularly trained to face cybersecurity threats and attacks. In the event of a cyberattack, Sanofi has established a plan
that includes criteria triggering the notification process for material cybersecurity incidents,, including from the cybersecurity
operation center and the Chief Information Security Officer who can use the internal escalation channels to inform the
management and the Board of Directors and, as appropriate, the relevant regulatory bodies.
When dealing with third parties , our main commercial contracts include cybersecurity clauses aimed at ensuring such third
parties comply with Sanofi’s cybersecurity rules and requirements, especially when providing services to and processing data
from Sanofi. Additionally, Sanofi set up a vendor’s risk assessment program to evaluate the digital maturity of a vendor, which
covers their business continuity as well as their related internal regulations, such as data privacy. As part of their contractual
commitments major vendors and partners must report to Sanofi any cybersecurity incident that may have a significant impact for
Sanofi. A dedicated process has been implemented for third parties’ networks interconnected with Sanofi’s network, aimed at
limiting any propagation of a cyberattack to Sanofi’s digital assets.
Sanofi’s cybersecurity risk management processes are integrated into its overall risk management system through its enterprise
risk management process, which seeks to identify and address material risks to the organization. Each year, specific risk
committees identify the risks that affect Sanofi’s local businesses in each country it operates and Sanofi’s global functions, such
as Research and Development or Manufacturing and Supply.
Although Sanofi has put in place the cybersecurity processes described above, Sanofi remains exposed to cybersecurity attacks
and incidents and misuse or manipulation of any of its IT systems, which could have a material adverse effect on its business
strategy, results of operations or financial condition (see “Item 3. Key Information — D. Risk factors — Risks relating to our
business — Breaches of data security, disruptions of information technology systems and cyber threats could result in financial,
legal, competitive, operational, business, or reputational harm”).
178 | SANOFI FORM 20-F 2025 |
PART II |
Item 16K. Cybersecurity |
Sanofi has appointed a Chief Information Security Officer who oversees Sanofi's information, cybersecurity, and technology
security. Our current Chief Information Security Officer has been working for Sanofi in this capacity since 2014 and has seventeen
years of experience in the cybersecurity industry, including eight years as the global head of cybersecurity at one of France’s
largest telecommunications companies. The Chief Information Security Officer is informed about and monitors the prevention,
detection, mitigation, and remediation of cybersecurity incidents through the cybersecurity operation center. He develops
appropriate plans to mitigate such risks. Such plans are validated by the Chief Digital Officer and shared with the Executive
Committee.
the Executive Committee. In addition, the Chief Information Security Officer is a permanent member of the group Risk
Committee and reports on the cybersecurity risk to such group Risk Committee, to the Audit Committee and to the Executive
Committee regularly. The reporting covers various matters, such as the outcomes of audits on Sanofi’s information systems, the
main incidents encountered over the preceding period, Sanofi’s digital transformation or the cybersecurity strategy and
framework for the coming years.
specific committees and targets the high priority risks Sanofi is facing. The group Risk Committee then allocates each risk to the
relevant Executive Committee member (i.e. the cybersecurity risk is allocated to the Chief Digital Officer as the relevant member
of the Executive Committee, who manages the mitigation of such risk with the Chief Information Security Officer) and reports
regularly to the Audit Committee. Following this identification and allocation process, the group Risk Committee reports on a
quarterly basis to the Executive Committee on the progress of the mitigation plans.
Directors. The Board of Directors is also informed of such risks, as well as other cybersecurity matters, through periodic reports
from the Chief Digital Officer, the Head of the group Risk Committee, or the Chief Information Security Officer.
SANOFI FORM 20-F 2025 | 179 |
PART III |
ITEM 17. Financial Statements |
Part III
Item 17. Financial Statements
See Item 18.
Item 18. Financial Statements
See pages F-1 through F-104 incorporated herein by reference.
Item 19. Exhibits
1.1. | Articles of association (statuts) of Sanofi (English translation). |
1.2. | Board Charter (Règlement Intérieur) of Sanofi (English translation) |
2.1. | The total amount of long-term debt securities authorized under any instrument does not exceed 10% of the total assets of the Company and its subsidiaries on a consolidated basis. We hereby agree to furnish to the SEC, upon its request, a copy of any instrument defining the rights of holders of long-term debt of the Company or of its subsidiaries for which consolidated or unconsolidated financial statements are required to be filed. |
2.2. | Description of securities registered under section 12 of the Exchange Act. |
4.1 | Share repurchase agreement between Sanofi and L'Oréal, dated February 2, 2025 (Incorporated by reference to Exhibit 4.3 of the Company’s Annual Report on Form 20-F for the year ended December 31, 2024) |
8.1. | List of significant subsidiaries, see “Item 4. Information on the Company — C. Organizational Structure” of this annual report. |
11.1 | Global Operating Procedure on the Prevention of Insider Trading (Incorporated by reference to Exhibit 11.1 of the Company’s Annual Report on Form 20-F for the year ended December 31, 2024) |
12.1. | Certification by Paul Hudson, Chief Executive Officer, required by Section 302 of the Sarbanes-Oxley Act of 2002. |
12.2. | Certification by Francois-Xavier Roger, Principal Financial Officer, required by Section 302 of the Sarbanes-Oxley Act of 2002. |
13.1. | Certification by Paul Hudson, Chief Executive Officer, required by Section 906 of the Sarbanes-Oxley Act of 2002. |
13.2. | Certification by Francois-Xavier Roger, Principal Financial Officer, required by Section 906 of the Sarbanes-Oxley Act of 2002. |
15.1. | Consent of PricewaterhouseCoopers Audit dated February 17, 2026. |
15.2. | Consent of Forvis Mazars SA dated February 17, 2026. |
15.3 | Consent of Ernst and Young dated February 17, 2026. |
97. | Clawback policy (Incorporated by reference to Exhibit 97 of the Company’s Annual Report on Form 20-F for the year ended December 31, 2023) |
101.INS | XBRL Instance Document. |
101.SCH | XBRL Taxonomy Extension Schema. |
101.CAL | XBRL Taxonomy Extension Calculation Linkbase. |
101.DEF | XBRL Taxonomy Extension Definition Linkbase. |
101.LAB | XBRL Taxonomy Extension Label Linkbase. |
101.PRE | XBRL Taxonomy Extension Presentation Linkbase. |
104.1 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
180 | SANOFI FORM 20-F 2025 |
Signatures |
Signature
The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and
authorized the undersigned to sign this annual report on its behalf.
Sanofi | |
By: | /s/ PAUL HUDSON |
Name: | Paul Hudson |
Title: | Chief Executive Officer |
Date: February 17, 2026
SANOFI FORM 20-F 2025 | 181 |
2025 CONSOLIDATED FINANCIAL STATEMENTS |
Report of Independent Registered Public Accounting Firms |
Report of Independent Registered Public Accounting Firms
To the Shareholders and the Board of Directors of Sanofi,
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of Sanofi and its subsidiaries (together the “Company”) as of
December 31, 2025, and 2024, the related consolidated income statements, and consolidated statements of comprehensive
income, of changes in equity and of cash flows for each of the two years in the period ended December 31, 2025, including the
related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial
statements present fairly, in all material respects, the financial position of the Company as of December 31, 2025, and 2024, and
the results of its operations and its cash flows for each of the two years in the period ended December 31, 2025 in conformity
with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board and in
conformity with IFRS as endorsed by the European Union.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States)
(“PCAOB”), the Company’s internal control over financial reporting as of December 31, 2025, based on criteria established in
Internal Control – Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission
(2013 framework) and our report dated February 17, 2026 expressed an unqualified opinion thereon.
Basis for Opinion
The Company's management is responsible for these consolidated financial statements. Our responsibility is to express an
opinion on the Company’s consolidated financial statements based on our audits. We are public accounting firms registered with
the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws
and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the
audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement,
whether due to error or fraud.
Our audits of the consolidated financial statements included performing procedures to assess the risks of material misstatement
of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks.
Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated
financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by
management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits
provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matters communicated below are matters arising from the current period audit of the consolidated financial
statements that were communicated or required to be communicated to the audit committee and that (1) relate to accounts or
disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or
complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated
financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate
opinions on the critical audit matters or on the accounts or disclosures to which they relate.
182 | SANOFI FORM 20-F 2025 |
2025 CONSOLIDATED FINANCIAL STATEMENTS |
Report of Independent Registered Public Accounting Firms |
Recoverable amount of other intangible assets - Acquired R&D, products, trademarks
and other rights
Description of the Matter | Other intangible assets composed of acquired R&D, products, trademarks and other rights amounted to €25,853 million at December 31, 2025. Management recognized a net loss of €2,242 million relating to impairment charges and reversals for the year ended December 31, 2025. As described in Notes B.6.1., D.4. and D.5. to the consolidated financial statements, other intangible assets not yet available for use are tested for impairment annually and whenever events or circumstances indicate that impairment might exist. Other intangible assets that generate separate cash flows and assets included in cash-generating units (CGUs) are assessed for impairment when events or changes in circumstances indicate that the asset or CGU may be impaired. Management estimates the recoverable amount of the asset and recognizes an impairment loss if the carrying amount of the asset exceeds its recoverable amount. The recoverable amount of the asset is the higher of its fair value less costs to sell or its value in use. Value in use is determined by management using estimated future cash flows generated by the asset or CGU which are discounted and prepared using the same methods as those used in the initial measurement of the assets and on the basis of medium-term strategic plans. Management cash flow projections include significant assumptions related to mid and long-term sales forecasts; perpetual growth or attrition rate, where applicable; discount rate; and probability of success of current research and development projects. The principal considerations for our determination that auditing the recoverable amount of other intangible assets is especially challenging, subjective, and required complex auditor judgment related to the significant judgments made by management when developing the significant assumptions utilized in the future cash flow projections as described above. |
How We Addressed the Matter in Our Audit | Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These audit procedures included obtaining an understanding of the process and assessing the design and testing the operating effectiveness of controls relating to management’s other intangible assets impairment assessment, including controls over the significant assumptions used in the impairment testing of the other intangible assets. These audit procedures also included, among others, testing management's process for developing the recoverable amount estimate of the other intangible assets, evaluating the appropriateness of the discounted cash flow model; testing the completeness, accuracy, and relevance of underlying data used in the model; and evaluating the significant assumptions used by management as described above. Evaluating management’s assumptions involved evaluating whether the assumptions used by management were reasonable by considering the current and past performance of other intangible assets in comparison to management’s previous forecasts and current trends, the consistency of certain assumptions with external market and industry data, and whether these assumptions were consistent with evidence obtained in other areas of the audit. We involved our professionals with specialized skills and knowledge to assist us notably in the assessment of the discount rate used by management. |
Valuation of the provisions for rebates relating to Sanofi’s business in the United States –
Medicaid, Medicare and Managed Care
Description of the Matter | As described in Notes B.13.1. and D.23. to the consolidated financial statements, products sold in the United States include estimates of discounts and rebates incentives (hereinafter the “Rebates”) that are recognized as a reduction of gross sales in the period in which the underlying sales are recognized. The most significant rebate liabilities relate to Medicaid, Medicare and Managed Care programs which amounted to €1,197 million, €1,402 million and €1,727 million, respectively, at December 31, 2025. The Rebates estimated by management are based on the nature and patient profile of the underlying product; the applicable regulations or the specific terms and conditions of contracts with governmental authorities, wholesalers, payers and other customers; historical data relating to similar contracts; past experience and sales growth trends for the same or similar products; actual inventory levels in distribution channels, monitored by Sanofi using internal sales data and externally provided data; market trends including competition, pricing and demand. The principal considerations for our determination that auditing the provisions for Rebates relating to the Company’s business in the United States is especially challenging and required complex auditor judgment related to the significant judgment by management due to significant measurement uncertainty involved in developing these provisions. These provisions are estimated based on multiple factors as described above. |
How We Addressed the Matter in Our Audit | Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These audit procedures included obtaining an understanding of the process and assessing the design and testing the operating effectiveness of controls relating to management’s estimates of the provisions for Rebates relating to the Company’s business in the United States, including controls over the assumptions used to estimate these Rebates. These procedures also included, among others, developing an independent estimate of the provisions for Rebates by utilizing third party data on inventory levels in distribution channels, volume, changes to price, the terms of the specific rebate programs, and the historical trend of actual rebate claims paid. Additionally, these procedures included testing actual rebate claims paid and evaluating the contractual terms of the Company’s rebate agreements. The independent estimate was compared to the provisions recorded by the Company. |
SANOFI FORM 20-F 2025 | 183 |
2025 CONSOLIDATED FINANCIAL STATEMENTS |
Report of Independent Registered Public Accounting Firms |
Provisions for product liability risks, litigation and other and contingent liabilities
Description of the Matter | Non-current provisions for product liability risks, litigation and other were recorded in an amount of €1,127 million at December 31, 2025. As described in Notes B.12., D.19.3. and D.22. to the consolidated financial statements, the Company records such provisions when an outflow of resources is probable and the amount of the outflow can be reliably estimated. The Company also discloses the contingent liabilities in circumstances where management is unable to make a reasonable estimate of the expected financial effect that will result from ultimate resolution of the proceeding, or a cash outflow is not probable. The pharmaceutical industry is highly regulated, which increases the inherent risk of litigation and arbitration. The Company is involved in litigation, arbitration and other legal proceedings. These proceedings are typically related to litigation concerning product liability claims, intellectual property rights, competition law and trade practices, as well as claims under warranties or indemnification arrangements relating to business divestments. The issues raised by these claims are highly complex and subject to substantial uncertainties; therefore, the probability of loss and an estimation of damages are difficult to ascertain. The principal considerations for our determination that auditing the provision for product liability risks, litigation and other, and auditing the contingent liabilities is especially challenging, subjective and required complex auditor judgment resulted from the determination that the measurement of the provisions can involve a series of complex judgments about future events and can rely heavily on estimates and assumptions by management. There is inherent uncertainty related to these cases and in estimating the likelihood and outcome of the cases. |
How We Addressed the Matter in Our Audit | Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These audit procedures included obtaining an understanding of the process and assessing the design and testing the operating effectiveness of controls relating to management’s evaluation of the provisions for product liability risks, litigation and other, including controls over determining whether a loss is probable and whether the amount of loss can be reasonably estimated, as well as the need for and the level of financial statement disclosures. These procedures also included, among others, obtaining and evaluating the letters of audit inquiry with internal and external legal counsels, evaluating management’s assessment regarding whether an unfavorable outcome is reasonably possible or probable and reasonably estimable through the evaluation of the legal letters and summaries of the proceedings and lawsuit correspondence. Professionals with specialized skill and knowledge were used to assist in evaluating certain legal letters from internal and external counsels. We also evaluated the Company’s disclosures for contingent liabilities. |
Uncertain tax positions
Description of the Matter | As described in Notes B.22. and D.19.4. to the consolidated financial statements, the Company has recorded non-current liabilities pertaining to uncertain tax positions of €2,081 million at December 31, 2025. The Company operates in multiple tax jurisdictions, carrying out potentially complex transactions that require management to make judgments and estimates as to the tax impact of those transactions. The positions adopted by the Company in tax matters are based on its interpretation of tax laws and regulations. Some of those positions may be subject to uncertainty. In such cases, the Company assesses the amount of the tax liability on the basis of the following assumptions: that its position will be examined by one or more tax authorities on the basis of all relevant information; that a technical assessment is carried out with reference to legislation, case law, regulations, and established practice; and that each position is assessed individually (or collectively where appropriate), with no offset or aggregation between positions. Those assumptions are assessed on the basis of facts and circumstances existing at the end of the reporting period. When an uncertain tax liability is regarded as probable, it is measured on the basis of the Company’s best estimate. The principal considerations for our determination that auditing uncertain tax positions is especially challenging, subjective and required complex auditor judgment related to the significant judgment by management when determining the liability for uncertain tax positions, including a high degree of estimation uncertainty of certain assumptions and interpretations of the tax laws and regulations underlying the positions. |
How We Addressed the Matter in Our Audit | Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These audit procedures included obtaining an understanding of the process and assessing the design and testing the operating effectiveness of controls relating to the identification and recognition of the liability for uncertain tax positions, management’s assessment and interpretation of tax laws and its evaluation of which tax positions may not be sustained upon audit and controls over measurement of the liability. These procedures also included, among others, testing the completeness and accuracy of the underlying data used in the calculation of the liability for uncertain tax positions and evaluating the assumptions used by management when determining its tax positions, the status of tax audits and investigations, and the potential impact of past claims. Our tax professionals assisted in evaluating management’s assessments by comparing the positions taken by management with tax regulations and past decisions from tax authorities and where applicable, evaluating opinions from the Company’s external tax advisors. We also evaluated the disclosures provided in the notes to the consolidated financial statements concerning uncertain tax positions. |
/s/ PricewaterhouseCoopers Audit | /s/ Forvis Mazars SA | |
184 | SANOFI FORM 20-F 2025 |
2025 CONSOLIDATED FINANCIAL STATEMENTS |
Report of Independent Registered Public Accounting Firms |
Report of Independent Registered Public Accounting Firms
To the Shareholders and the Board of Directors of Sanofi,
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of Sanofi and its subsidiaries ("the Company") as of December
31, 2023, the related consolidated income statements, and consolidated statements of comprehensive income, changes in
equity, and cash flows for the year ended December 31, 2023, and the related notes (collectively, "the consolidated financial
statements"), before the effects of the adjustments to retrospectively reflect the classification as discontinued operations of
Opella described in Note D.1.1.1.
In our opinion, the consolidated financial statements, before the effects of the adjustments to retrospectively reflect the
classification as discontinued operations of Opella described in Note D.1.1.1, present fairly, in all material respects, the financial
position of the Company as of December 31, 2023, and the results of its operations and its cash flows for the year ended
December 31, 2023, in conformity with International Financial Reporting Standards as issued by the International Accounting
Standards Board and in conformity with International Financial Reporting Standards as endorsed by the European Union (the
2023 financial statements before the effects of the adjustments described in Note D.1.1.1 are not presented herein).
ERNST & YOUNG et Autres was not engaged to audit, review, or apply any procedures to the adjustments to retrospectively
reflect the classification as discontinued operations of Opella described in Note D.1.1.1, and, accordingly ERNST & YOUNG et
Autres does not express an opinion or any other form of assurance about whether such adjustments are appropriate and have
been properly applied. Those adjustments were audited by PricewaterhouseCoopers Audit in 2024. In the opinion of
PricewaterhouseCoopers Audit, such adjustments are appropriate and have been properly applied.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company's management. Our responsibility is to express an
opinion on these consolidated financial statements based on our audit. We are public accounting firms registered with the Public
Company Accounting Oversight Board (United States) ("PCAOB") and are required to be independent with respect to the
Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and
Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the
audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement,
whether due to error or fraud.
Our audit included performing procedures to assess the risks of material misstatement of the consolidated financial statements,
whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a
test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audit also included
evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall
presentation of the consolidated financial statements. We believe that our audit provides a reasonable basis for our opinion.
/s/ PricewaterhouseCoopers Audit | /s/ ERNST & YOUNG et Autres | |
PricewaterhouseCoopers Audit and ERNST & YOUNG et Autres have served as the Company’s auditors since 1999 and 1986 to
2024, respectively.
Neuilly-sur-Seine, France, February 23, 2024, except for the effects of the classification as discontinued operations of Opella described in Note D.1.1.1, as to which the date is February 13, 2025 | Paris La Défense, France, February 23, 2024 |
SANOFI FORM 20-F 2025 | 185 |
2025 CONSOLIDATED FINANCIAL STATEMENTS |
Report of Independent Registered Public Accounting Firms |
Report of Independent Registered Public Accounting Firms
To the Shareholders and the Board of Directors of Sanofi,
Opinion on Internal Control over Financial Reporting
We have audited Sanofi and its subsidiaries’ (together the “Company”) internal control over financial reporting as of December 31,
2025, based on criteria established in Internal Control - Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission (2013 framework) (the “COSO criteria”). In our opinion, the Company maintained, in
all material respects, effective internal control over financial reporting as of December 31, 2025, based on the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States)
(“PCAOB”), the consolidated balance sheets of the Company as of December 31, 2025 and 2024, the related consolidated
income statements, and consolidated statements of comprehensive income, of changes in equity and of cash flows for each of
the two years ended December 31, 2025, including the related notes (collectively referred to as the “consolidated financial
statements”) and our report dated February 17, 2026 expressed an unqualified opinion thereon.
As indicated in Report of Management on Internal Control Over Financial Reporting appearing under Item 15, management’s
assessment and conclusion on the effectiveness of internal control over financial reporting did not include the internal controls of
Blueprint Medicines Corporation and its affiliates, which are included in the 2025 consolidated financial statements of the
Company and represented less than 1% of total assets as of December 31, 2025 and less than 1% of net sales for the year then
ended. Our audit of internal control over financial reporting of the Company also did not include an evaluation of the internal
control over financial reporting of Blueprint Medicines Corporation and its affiliates.
Basis for Opinion
The Company's management is responsible for maintaining effective internal control over financial reporting, and for its
assessment of the effectiveness of internal control over financial reporting, included in the Report of Management on Internal
Control Over Financial Reporting appearing under Item 15. Our responsibility is to express an opinion on the Company's internal
control over financial reporting based on our audit. We are public accounting firms registered with the PCAOB and are required
to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and
regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the
audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all
material respects.
Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial
reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of
internal control based on the assessed risk. Our audits also included performing such other procedures as we considered
necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally
accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that
(1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions
of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation
of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the
company are being made only in accordance with authorizations of management and directors of the company; and (3) provide
reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s
assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also,
projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate
because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
/s/ PricewaterhouseCoopers Audit | /s/ Forvis Mazars SA | |
Neuilly-sur-Seine and Levallois-Perret , France, February 17, 2026
186 | SANOFI FORM 20-F 2025 |
2025 CONSOLIDATED FINANCIAL STATEMENTS |
[THIS PAGE HAS BEEN INTENTIONALLY LEFT BLANK] |
SANOFI FORM 20-F 2025 | F-1 |
2025 CONSOLIDATED FINANCIAL STATEMENTS |
2025 Consolidated financial statements
The financial statements are presented in accordance with International Financial Reporting Standards (IFRS).
CONSOLIDATED BALANCE SHEETS – ASSETS | F-2 |
CONSOLIDATED BALANCE SHEETS – EQUITY AND LIABILITIES | F-3 |
CONSOLIDATED INCOME STATEMENTS | F-4 |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME | F-5 |
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY | F-6 |
CONSOLIDATED STATEMENTS OF CASH FLOWS | F-8 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS | F-10 |
INTRODUCTION | F-10 |
A/ Basis of preparation | F-10 |
B/ Summary of significant accounting policies | F-11 |
C/ Principal alliances | F-28 |
D/ Presentation of the financial statements | F-31 |
E/ Principal accountants’ fees and services | F-100 |
F/ List of principal companies included in the consolidation during 2025 | F-101 |
G/ Events subsequent to December 31, 2025 | F-104 |
F-2 | SANOFI FORM 20-F 2025 |
2025 CONSOLIDATED FINANCIAL STATEMENTS |
Consolidated balance sheets - assets |
Consolidated balance sheets - assets
(€ million) | Note | December 31, 2025 | December 31, 2024 | December 31, 2023 |
Property, plant and equipment | D.3.1. | |||
Right-of-use assets | D.3.2. | |||
Goodwill | D.4. | |||
Other intangible assets | D.4. | |||
Investments accounted for using the equity method | D.6. | |||
Other non-current assets | D.7. | |||
Non-current income tax assets | ||||
Deferred tax assets | D.14. | |||
Non-current assets | ||||
Inventories | D.9. | |||
Accounts receivable | D.10. | |||
Other current assets | D.11. | |||
Current income tax assets | ||||
Cash and cash equivalents | D.13. - D.17.1. | |||
Assets held for sale | D.8. - D.36. | |||
Current assets | ||||
Total assets |
SANOFI FORM 20-F 2025 | F-3 |
2025 CONSOLIDATED FINANCIAL STATEMENTS |
Consolidated balance sheets - equity and liabilities |
Consolidated balance sheets – equity and liabilities
(€ million) | Note | December 31, 2025 | December 31, 2024 | December 31, 2023 |
Equity attributable to equity holders of Sanofi | D.15. | |||
Equity attributable to non-controlling interests | D.16. | |||
Total equity | ||||
Long-term debt | D.17.1. | |||
Non-current lease liabilities | D.17.2. | |||
Non-current liabilities related to business combinations and to non-controlling interests | D.18. | |||
Non-current provisions and other non-current liabilities | D.19. | |||
Non-current income tax liabilities | D.19.4. | |||
Deferred tax liabilities | D.14. | |||
Non-current liabilities | ||||
Accounts payable | ||||
Current liabilities related to business combinations and to non-controlling interests | D.18. | |||
Current provisions and other current liabilities | D.19.5. | |||
Current income tax liabilities | ||||
Current lease liabilities | D.17.2. | |||
Short-term debt and current portion of long-term debt | D.17.1. | |||
Liabilities related to assets held for sale | D.8. - D.36. | |||
Current liabilities | ||||
Total equity and liabilities |
F-4 | SANOFI FORM 20-F 2025 |
2025 CONSOLIDATED FINANCIAL STATEMENTS |
Consolidated income statements |
Consolidated income statements
(€ million) | Note | 2025 | 2024 | 2023(a) |
Net sales | D.34. | |||
Other revenues | D.34. | |||
Cost of sales | ( | ( | ( | |
Gross profit | ||||
Research and development expenses | ( | ( | ( | |
Selling and general expenses | ( | ( | ( | |
Other operating income | D.25. | |||
Other operating expenses | D.26. | ( | ( | ( |
Amortization of intangible assets | D.4. | ( | ( | ( |
Impairment of intangible assets | D.5. | ( | ( | ( |
Fair value remeasurement of contingent consideration | D.12. - D.18. | ( | ( | ( |
Restructuring costs and similar items | D.27. | ( | ( | ( |
Other gains and losses, and litigation | D.28. | ( | ( | ( |
Operating income | ||||
Financial expenses | D.29. | ( | ( | ( |
Financial income | D.29. | |||
Income before tax and investments accounted for using the equity method | D.35.1. | |||
Income tax expense | D.30. | ( | ( | ( |
Share of profit/(loss) from investments accounted for using the equity method | D.31. | ( | ( | |
Net income from continuing operations | ||||
Net income from discontinued operations | D.36. | |||
Net income | ||||
Net income attributable to non-controlling interests | D.32. | |||
Net income attributable to equity holders of Sanofi | ||||
Average number of shares outstanding (million) | D.15.9. | |||
Average number of shares after dilution (million) | D.15.9. | |||
•Basic earnings per share from continuing operations (€) | ||||
•Basic earnings per share from discontinued operations (€) | ||||
Basic earnings per share (€) | ||||
•Diluted earnings per share from continuing operations (€) | ||||
•Diluted earnings per share from discontinued operations (€) | ||||
Diluted earnings per share (€) |
SANOFI FORM 20-F 2025 | F-5 |
2025 CONSOLIDATED FINANCIAL STATEMENTS |
Consolidated statements of comprehensive income |
Consolidated statements of comprehensive income
(€ million) | Note | 2025 | 2024 | 2023 |
Net income | ||||
Attributable to equity holders of Sanofi | ||||
Attributable to non-controlling interests | ||||
Other comprehensive income: | ||||
•Actuarial gains/(losses) | D.15.7. | ( | ||
•Change in fair value of equity instruments included in financial assets and financial liabilities | D.15.7. | ( | ||
•Tax effects | D.15.7. | ( | ( | ( |
Sub-total: items not subsequently reclassifiable to profit or loss from continuing operations (A) | ( | ( | ||
•Change in fair value of debt instruments included in financial assets | D.15.7. | |||
•Change in fair value of cash flow hedges | D.15.7. | ( | ( | ( |
•Change in currency translation differences | D.15.7. | ( | ( | |
•Tax effects | D.15.7. | ( | ( | |
Sub-total: items subsequently reclassifiable to profit or loss from continuing operations (B) | ( | ( | ||
Other comprehensive income / (loss) from continuing operations for the period, net of taxes (A+B) | ( | ( | ||
Other comprehensive income / (loss) for the period from discontinued operations, net of taxes (C) | ( | ( | ||
Comprehensive income | ||||
Attributable to equity holders of Sanofi | ||||
•Continuing operations | ( | |||
•Discontinued operations | ||||
Attributable to non-controlling interests | ( |
F-6 | SANOFI FORM 20-F 2025 |
2025 CONSOLIDATED FINANCIAL STATEMENTS |
Consolidated statements of changes in equity |
Consolidated statements of changes in equity
(€ million) | Share capital | Additional paid-in capital | Treasury shares | Reserves and retained earnings | Stock options and other share- based payments | Other comprehensive income | Attributable to equity holders of Sanofi | Attributable to non- controlling interests | Total equity |
Balance at January 1, 2023 | ( | ||||||||
Other comprehensive income for the period | — | — | — | ( | — | ( | ( | ( | ( |
Net income for the period | — | — | — | — | — | ||||
Comprehensive income for the period | — | — | — | — | ( | ||||
Dividend paid out of 2022 earnings (€ | — | — | — | ( | — | — | ( | — | ( |
Payment of dividends to non-controlling interests | — | — | — | — | — | — | ( | ( | |
Share repurchase program(a) | — | — | ( | — | — | — | ( | — | ( |
Share-based payment plans: | |||||||||
•Exercise of stock options(a) | — | — | — | — | — | ||||
•Issuance of restricted shares and vesting of existing restricted shares(a) (d) | ( | ( | — | — | — | ||||
•Employee share ownership plan(a) | — | — | — | — | — | ||||
•Value of services obtained from employees | — | — | — | — | — | — | |||
•Tax effects on share-based payments | — | — | — | — | — | — | |||
Other changes arising from issuance of restricted shares(c) | — | — | — | — | — | ||||
Other changes in non-controlling interests (e) | — | — | — | — | ( | ( | |||
Balance at December 31, 2023 | ( | ( |
(€ million) | Share capital | Additional paid-in capital | Treasury shares | Reserves and retained earnings | Stock options and other share- based payments | Other comprehensive income | Attributable to equity holders of Sanofi | Attributable to non- controlling interests | Total equity |
Balance at January 1, 2024 | ( | ( | |||||||
Other comprehensive income for the period | — | — | — | ( | — | ||||
Net income for the period | — | — | — | — | — | ||||
Comprehensive income for the period | — | — | — | — | |||||
Dividend paid out of 2023 earnings (€ | — | — | — | ( | — | — | ( | — | ( |
Payment of dividends to non- controlling interests | — | — | — | — | — | — | ( | ( | |
Share repurchase program(a) | — | — | ( | — | — | — | ( | — | ( |
Reduction in share capital (a) | ( | ( | ( | — | — | — | |||
Share-based payment plans: | |||||||||
•Exercise of stock options(a) | — | — | — | — | — | ||||
•Issuance of restricted shares and vesting of existing restricted shares(a)/(d) | ( | ( | — | — | — | ||||
•Employee share ownership plan(a) | — | — | — | — | — | ||||
•Value of services obtained from employees | — | — | — | — | — | — | |||
•Tax effects on share-based payments | — | — | — | — | — | — | |||
Other changes arising from issuance of restricted shares(c) | — | — | — | — | — | — | |||
Change in non-controlling interests without loss of control | — | — | — | ( | — | — | ( | ||
Balance at December 31, 2024 | ( |
SANOFI FORM 20-F 2025 | F-7 |
2025 CONSOLIDATED FINANCIAL STATEMENTS |
Consolidated statements of changes in equity |
(€ million) | Share capital | Additional paid-in capital | Treasury shares | Reserves and retained earnings | Stock options and other share- based payments | Other comprehensive income | Attributable to equity holders of Sanofi | Attributable to non- controlling interests | Total equity |
Balance at January 1, 2025 | ( | ||||||||
Other comprehensive income for the period | — | — | — | — | ( | ( | ( | ( | |
Net income for the period | — | — | — | — | — | ||||
Comprehensive income for the period | — | — | — | — | ( | ( | |||
Dividend paid out of 2024 earnings (€ | — | — | — | ( | — | — | ( | — | ( |
Payment of dividends to non-controlling interests | — | — | — | — | — | — | ( | ( | |
Share repurchase program(a) | — | — | ( | — | — | — | ( | — | ( |
Reduction in share capital(a) | ( | ( | ( | — | — | — | |||
Taxes on share cancellations(b) | — | — | ( | — | — | ( | — | ( | |
Share-based payment plans: | |||||||||
•Exercise of stock options(a) | — | — | — | — | — | ||||
•Issuance of restricted shares and vesting of existing restricted shares(a)/(d) | ( | — | — | — | |||||
•Employee share ownership plan(a) | — | — | — | — | — | ||||
•Value of services obtained from employees | — | — | — | — | — | — | |||
•Tax effects on share-based payments | — | — | — | — | ( | — | ( | — | ( |
Other changes arising from issuance of restricted shares(c) | — | — | — | — | — | — | |||
Changes in non-controlling interests(e) | — | — | — | — | — | ||||
Balance at December 31, 2025 | ( | ( |
(c)This line comprises the impact of the issuance of restricted shares to former employees of OPELLA in 2025 subsequent to the date on which Sanofi lost
control of OPELLA. In 2023 and 2024, this line comprises the impact of the issuance of restricted shares to former employees of EUROAPI subsequent to
the date on which Sanofi lost control of EUROAPI.
(d)This line includes the use of existing shares to fulfill vested rights under restricted share plans.
(e)This line mainly comprises changes in non-controlling interests arising from divestments and acquisitions.
F-8 | SANOFI FORM 20-F 2025 |
2025 CONSOLIDATED FINANCIAL STATEMENTS |
Consolidated statements of cash flows |
Consolidated statements of cash flows
(€ million) | Note | 2025 | 2024 | 2023(a) |
Net income attributable to equity holders of Sanofi | ||||
Net (income)/loss from the discontinued Opella business | ( | ( | ( | |
Non-controlling interests | D.32. | |||
Share of undistributed earnings from investments accounted for using the equity method | ||||
Depreciation, amortization and impairment of property, plant and equipment, right-of-use assets and intangible assets | ||||
Gains and losses on disposals of non-current assets, net of tax(b) | ( | ( | ( | |
Net change in deferred taxes | ( | ( | ( | |
Net change in non-current provisions and other non-current liabilities(c) | ( | |||
Cost of employee benefits (stock options and share-based payments) | D.15.2. - D.15.3. - D.15.8. | |||
Impact of the workdown of acquired inventories remeasured at fair value | D.35.1. | |||
Other profit or loss items with no cash effect on cash flows generated by operating activities(d) | ||||
Operating cash flow before changes in working capital | ||||
(Increase)/decrease in inventories | ( | ( | ( | |
(Increase)/decrease in accounts receivable | ( | ( | ( | |
Increase/(decrease) in accounts payable | ||||
Net change in other current assets and other current liabilities | ( | |||
Net cash provided by/(used in) continuing operating activities | ||||
Net cash provided by/(used in) operating activities of the discontinued Opella business | ||||
Net cash provided by/(used in) operating activities(e) | ||||
Acquisition of property, plant and equipment and intangible assets | D.3. - D.4. | ( | ( | ( |
Acquisitions of consolidated undertakings and investments accounted for using the equity method(f) | D.1. - D.18. | ( | ( | ( |
Acquisitions of other equity investments | D.7. | ( | ( | ( |
Proceeds from disposals of property, plant and equipment, intangible assets and other non-current assets, net of tax(g) | ||||
Disposal of consolidated undertakings and investments accounted for using the equity method, net of tax | ||||
Net change in other non-current assets | ( | ( | ( | |
Net cash provided by/(used in) continuing investing activities | ( | ( | ( | |
Net cash provided by/(used in) investing activities of the discontinued Opella business (h) | ( | ( | ( | |
Net cash inflow from the Opella transaction (i) | D.1.1.1. | |||
Net cash provided by/(used in) investing activities | ( | ( | ( | |
Issuance of Sanofi shares | D.15.1. | |||
Dividends paid: | ||||
•to shareholders of Sanofi | ( | ( | ( | |
•to non-controlling interests | ( | ( | ( | |
Payments received/(made) on changes of ownership interest in a subsidiary without loss of control | ( | |||
Additional long-term debt contracted | D.17.1. | |||
Repayments of long-term debt | D.17.1. | ( | ( | ( |
Repayments of lease liabilities | ( | ( | ( | |
Net change in short-term debt and other financial instruments(j) | ( | |||
Acquisitions of treasury shares and related tax effect | D.15.4. | ( | ( | ( |
Net cash provided by/(used in) continuing financing activities | ( | ( | ( | |
Net cash provided by/(used in) financing activities of the discontinued Opella business | ( | ( | ( | |
Net cash provided by/(used in) financing activities | ( | ( | ( | |
Impact of exchange rates on cash and cash equivalents | ( | ( | ( | |
Cash and cash equivalents reclassified to Assets held for sale as of December 31, 2024 | ( | |||
Net change in cash and cash equivalents | ( | ( | ||
Cash and cash equivalents, beginning of period | ||||
Cash and cash equivalents, end of period | D.13. |
(b) Includes non-current financial assets and deferred taxes amounting to €45 million in 2025, €(146 ) million in 2024 and €(1 ) million in 2023.
SANOFI FORM 20-F 2025 | F-9 |
2025 CONSOLIDATED FINANCIAL STATEMENTS |
Consolidated statements of cash flows |
(c)This line item includes contributions paid to pension funds (see Note D.19.1.).
(d)This line item mainly comprises unrealized foreign exchange gains and losses arising on the remeasurement of monetary items in non-functional
currencies and on instruments used to hedge such items.
(e)Including:
2025 | 2024 | 2023 | |
•Income tax paid | ( | ( | ( |
•Interest paid | ( | ( | ( |
•Interest received | |||
•Dividends received from non-consolidated entities |
(f)This line item includes payments made in respect of contingent consideration identified and recognized as a liability in business combinations. For 2025,
this line item includes the net cash outflow arising from the acquisitions of Dren-0201, Inc. (see Note D.1.1.2.), of Vigil Neuroscience, Inc. (see Note D.1.1.3.),
of Blueprint Medicines Corporation (see Note D.1.1.4) and of Vicebio Ltd. (see Note D.1.1.5). For 2024, it includes the net cash outflow relating to the
acquisition of Inhibrx, Inc. (see Note D.1.2.). For 2023, it includes the net cash outflow on the acquisitions of Provention Bio (see Note D.1.3.).
instruments. For 2024, this line item includes the sale of the Enjaymo global rights to Recordati for pre-tax proceeds of €768 million.
and cash equivalents held by Opella amounted to €167 million and were reported in "Assets held for sale" in the balance sheet as of that date.
(primarily the US dollar) and (ii) derivative instruments used to manage such cash and cash equivalents. For 2025, it also includes (i) a cash outflow of
€356 million relating to a US commercial paper program and (ii) a cash outflow of €666 million arising from the settlement on July 18, 2025 of the
financial liabilities of Blueprint Medicines, acquired on July 17, 2025 (see Note D.1.1.4). For 2024, this line item mainly comprises a US commercial paper
program for €262 million.
F-10 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
Notes to the Consolidated Financial Statements
Sanofi, together with its subsidiaries (collectively “Sanofi”, “the Group” or “the Company”), is a global healthcare leader engaged
in the research, development and marketing of therapeutic solutions focused on patient needs.
Sanofi is listed in Paris (Euronext: SAN) and New York (Nasdaq: SNY).
The consolidated financial statements for the year ended December 31, 2025, and the notes thereto, were signed off by the
Sanofi Board of Directors on January 28, 2026.
A/ Basis of preparation
A.1. International financial reporting standards (IFRS)
The consolidated financial statements cover the twelve-month periods ended December 31, 2025, 2024 and 2023.
In accordance with Regulation No. 1606/2002 of the European Parliament and Council of July 19, 2002 on the application
of international accounting standards, Sanofi has presented its consolidated financial statements in accordance with IFRS
since January 1, 2005. The term “IFRS” refers collectively to international accounting and financial reporting standards
(IASs and IFRSs) and to interpretations of the interpretations committees (SIC and IFRIC) with mandatory application as of
December 31, 2025.
The consolidated financial statements of Sanofi as of December 31, 2025 have been prepared in compliance with IFRS
as issued by the International Accounting Standards Board (IASB) and with IFRS as endorsed by the EU as of December 31, 2025.
IFRS as endorsed by the EU as of December 31, 2025 are available under the heading “IFRS Financial Statements” via the
following web link:
https://www.efrag.org/Endorsement
The consolidated financial statements have been prepared in accordance with the IFRS general principles of fair presentation,
going concern, accrual basis of accounting, consistency of presentation, materiality, and aggregation.
A.2. New standards, amendments and interpretations
A.2.1. New standards applicable from January 1, 2025
On August 15, 2023, the IASB issued "Lack of Exchangeability", an amendment to IAS 21 (The Effects of Changes in Foreign
Exchange Rates), relating to how to determine the exchange rate when a currency is not exchangeable. The amendment became
applicable on January 1, 2025, and did not have any material impact on the Sanofi financial statements.
On November 28, 2025, the IASB issued "Disclosures about Uncertainties in the Financial Statements", which includes illustrative
examples on how an entity applies the requirements in IFRS Accounting Standards to report the effects of uncertainties in its
financial statements. Those illustrative examples did not have any material impact on the Sanofi financial statements.
A.2.2. New pronouncements issued by the IASB and applicable from 2026 or later
This note describes standards, amendments and interpretations issued by the IASB that will have mandatory application in 2026
or subsequent years, and Sanofi’s position regarding future application.
On April 9, 2024, the IASB issued IFRS 18 (Presentation and Disclosure in Financial Statements), applicable from January 1, 2027.
Sanofi will not early adopt this new standard. The transition to IFRS 18 is in progress.
The assessment of the impacts of IFRS 18 transition on presentation and disclosure in Sanofi's consolidated financial statements is
ongoing. That assessment is addressing the requirement for subtotals in income statements; the classification of income and
expenses in defined categories such as operating, investing and financing; aggregation/disaggregation principles; disclosure of
management-defined performance measures; and the presentation of financial performance.
The future structure of the income statement will present operating expenses by function, with some line item adjustments based
on the "useful structured summary" principle under IFRS 18.
Management Performance Measures (MPMs) identified to date are "Business gross margin", "Business Operating Income" (BOI)
and "Business Net Income" (BNI); these are the non-IFRS measures that Sanofi currently uses in its financial communications, and
that are reconciled to its IFRS income statement in its management commentary (see "Item 5. Operating and Financial Review
and Prospects").
From 2027 onwards, those MPMs will be defined and reconciled in the notes to the financial statements, with no significant
change expected in their definition.
SANOFI FORM 20-F 2025 | F-11 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
On May 30, 2024, the IASB issued amendments to IFRS 9 and IFRS 7 relating to the classification and measurement of financial
instruments, applicable from January 1, 2026. Sanofi does not expect any material impact, and will not early adopt these
amendments.
On July 18, 2024, the IASB issued Volume 11 of its annual improvements to various standards, which are essentially in the nature of
clarifications, applicable from January 1, 2026 at the earliest. Sanofi does not expect any material impact, and will not early adopt
these amendments.
On December 18, 2024, the IASB issued "Contracts referencing nature-dependent electricity", amendments to IFRS 9 and IFRS 7,
applicable from January 1, 2026. The amendments clarify the application of the ‘own use’ exemption to Power Purchase
Agreements (PPAs) with physical delivery of renewable energy, and modify the hedge accounting requirements for contracts
without physical delivery (VPPAs). Sanofi does not expect any material impact and does not intend to early adopt these
amendments. Renewable energy purchase contracts entered into by Sanofi as of December 31, 2024 are described in note D.21.
Sanofi had not entered into any significant new long-term renewable energy purchase contracts as of December 31, 2025.
On November 13, 2025, the IASB issued "The Effects of Changes in Foreign Exchange Rates: Translation to a Hyperinflationary
Presentation Currency", amendments to IAS 21 that are applicable from January 1, 2027 (subject to endorsement by the EU).
A.3. Use of estimates and judgments
The preparation of financial statements requires management to make reasonable estimates and assumptions based on
information available at the date of the finalization of the financial statements. Those estimates and assumptions may affect the
reported amounts of assets, liabilities, revenues and expenses in the financial statements, and disclosures of contingent assets
and contingent liabilities as of the date of the review of the financial statements. Examples of estimates and assumptions include:
•amounts deducted from sales for projected sales returns, chargeback incentives, rebates and price reductions (see Notes B.13.
and D.23.);
•impairment of property, plant and equipment and intangible assets (see Notes B.6. and D.5.);
•the valuation of goodwill and the valuation and estimated useful life of acquired intangible assets (see Notes B.3.2., B.4., D.4.
and D.5.);
•the amount of liabilities or provisions for restructuring, litigation, tax risks relating to corporate income taxes, and
environmental risks (see Notes B.12., B.19., B.20., D.19. and D.22.).
Actual results could differ from these estimates.
A.4. Hyperinflation
In 2025, Sanofi continued to account for subsidiaries based in Venezuela using the full consolidation method, on the basis that
the criteria for control as specified in IFRS 10 (Consolidated Financial Statements) are still met. The contribution of the
Venezuelan subsidiaries to the consolidated financial statements is immaterial.
In Argentina, the cumulative rate of inflation over the last three years is in excess of 100 %, based on a combination of indices used
to measure inflation in that country. Consequently, Sanofi has since July 1, 2018 treated Argentina as a hyperinflationary economy
and has applied IAS 29. The impact of the resulting restatements is immaterial at Sanofi group level.
In Turkey, the cumulative rate of inflation over the last three years is in excess of 100 % based on a combination of indices used to
measure inflation in that country. Consequently, Sanofi has since January 1, 2022 treated Turkey as a hyperinflationary economy
and has applied IAS 29. The impact of the resulting restatements is immaterial at Sanofi group level.
B/ Summary of significant accounting policies
B.1. Basis of consolidation
In accordance with IFRS 10 (Consolidated Financial Statements), the consolidated financial statements of Sanofi include the
financial statements of entities that Sanofi controls directly or indirectly, regardless of the level of the equity interest in those
entities. An entity is controlled when Sanofi has power over the entity, exposure or rights to variable returns from its involvement
with the entity, and the ability to affect those returns through its power over the entity. In determining whether control exists,
potential voting rights must be taken into account if those rights are substantive, in other words they can be exercised on a
timely basis when decisions about the relevant activities of the entity are to be taken.
Entities consolidated by Sanofi are referred to as “subsidiaries”. Entities that Sanofi controls by means other than voting rights are
referred to as “consolidated structured entities”.
In accordance with IFRS 11 (Joint Arrangements), Sanofi classifies its joint arrangements (i.e. arrangements in which Sanofi
exercises joint control with one or more other parties) either as a joint operation (in which case, Sanofi recognizes the assets and
liabilities of the operation in proportion to its rights and obligations relating to those assets and liabilities) or as a joint venture.
F-12 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
Sanofi exercises joint control over a joint arrangement when decisions relating to the relevant activities of the arrangement
require the unanimous consent of Sanofi and the other parties with whom control is shared.
Sanofi exercises significant influence over an entity when it has the power to participate in the financial and operating policy
decisions of that entity, but does not have the power to exercise control or joint control over those policies.
In accordance with IAS 28 (Investments in Associates and Joint Ventures), the equity method is used to account for joint ventures
(i.e. entities over which Sanofi exercises joint control) and for associates (i.e. entities over which Sanofi exercises significant
influence).
Under the equity method, the investment is initially recognized at cost, and subsequently adjusted to reflect changes in the net
assets of the associate or joint venture. IAS 28 does not specify the treatment to be adopted on first-time application of the
equity method to an investee following a step acquisition. Consequently, by reference to paragraph 10 of IAS 28, Sanofi has
opted to apply the cost method, whereby the carrying amount of the investment represents the sum of the historical cost
amounts for each step in the acquisition. As of the date on which the equity method is first applied, goodwill (which is included in
the carrying amount of the investment) is determined for each acquisition step. The same applies to subsequent increases in the
percentage interest in the equity-accounted investment.
When the criteria of IFRS 5 are met, Sanofi recognizes the equity interest within the balance sheet line item Assets held for sale.
The equity method is not applied to equity interests that are classified as held for sale assets.
Transactions between consolidated companies are eliminated, as are intragroup profits.
A list of the principal companies included in the consolidation in 2025 is presented in Note F.
B.2. Foreign currency translation
B.2.1. Accounting for foreign currency transactions in the financial statements of consolidated
entities
Non-current assets and inventories acquired in foreign currencies are translated into the functional currency using the exchange
rate prevailing at the acquisition date.
Monetary assets and liabilities denominated in foreign currencies are translated using the exchange rate prevailing at the end of
the reporting period. The gains and losses resulting from foreign currency translation are recorded in the income statement.
However, foreign exchange gains and losses arising from the translation of advances between consolidated subsidiaries for which
settlement is neither planned nor likely to occur in the foreseeable future are recognized in equity, in the line item Change in
currency translation differences.
B.2.2. Foreign currency translation of the financial statements of foreign entities
Sanofi presents its consolidated financial statements in euros (€). In accordance with IAS 21 (The Effects of Changes in Foreign
Exchange Rates), each subsidiary accounts for its transactions in the currency that is most representative of its economic
environment (the functional currency).
All assets and liabilities are translated into euros using the exchange rate of the subsidiary’s functional currency prevailing at the
end of the reporting period. Income statements are translated using a weighted average exchange rate for the period, except in
the case of foreign subsidiaries in a hyperinflationary economy. The resulting currency translation difference is recognized as a
separate component of equity in the consolidated statement of comprehensive income, and is recognized in the income
statement only when the subsidiary is sold or is wholly or partially liquidated.
B.3. Business combinations and transactions with non-controlling interests
B.3.1. Accounting for business combinations, transactions with non-controlling interests and loss
of control
Business combinations are accounted for in accordance with IFRS 3 (Business Combinations) and IFRS 10 (Consolidated Financial
Statements).
Business combinations are accounted for using the acquisition method. Under this method, the acquiree’s identifiable assets and
liabilities that satisfy the recognition criteria of IFRS 3 (Business Combinations) are measured initially at their fair values at the
date of acquisition, except for (i) non-current assets classified as held for sale (which are measured at fair value less costs to sell)
and (ii) assets and liabilities that fall within the scope of IAS 12 (Income Taxes) and IAS 19 (Employee Benefits). Restructuring
liabilities are recognized as a liability of the acquiree only if the acquiree has an obligation as of the acquisition date to carry out
the restructuring.
The principal accounting rules applicable to business combinations and transactions with non-controlling interests include:
•acquisition-related costs are recognized as an expense, as a component of Operating income;
•contingent consideration is recognized in equity if the contingent payment is settled by delivery of a fixed number
of the acquirer’s equity instruments; otherwise, it is recognized in liabilities related to business combinations.
SANOFI FORM 20-F 2025 | F-13 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
Contingent consideration is recognized irrespective of the probability of payment and measured at fair value at the acquisition
date . If the contingent consideration was originally recognized as a financial liability, subsequent adjustments to the liability
are recognized in profit or loss in the line item Fair value remeasurement of contingent consideration, unless the
adjustment is made within the 12 months following the acquisition date and relates to facts and circumstances existing as of
that date; and
•goodwill may be calculated on the basis of either (i) the entire fair value of the acquiree, or (ii) a share of the fair value of the
acquiree proportionate to the interest acquired. This option is elected for each acquisition individually.
Purchase price allocations are performed under the responsibility of management, with assistance from an independent valuer in
the case of major acquisitions. IFRS 3 does not specify an accounting treatment for contingent consideration arising from a
business combination made by an entity prior to the acquisition of control in that entity and carried as a liability in the acquired
entity’s balance sheet. The accounting treatment applied by Sanofi to such a liability is to measure it at fair value as of the
acquisition date and to report it in the line item Liabilities related to business combinations and to non-controlling interests,
with subsequent remeasurements recognized in profit or loss. This treatment is consistent with the accounting applied to
contingent consideration in the books of the acquirer.
Finally, management may where it deems fit elect to apply the optional test to identify concentration of fair value permitted
under IFRS 3 in order to determine whether a transaction is a business combination within the meaning of IFRS 3, or merely the
acquisition of an asset or of a group of similar assets.
B.3.2. Goodwill
The excess of the cost of an acquisition over Sanofi’s interest in the fair value of the identifiable assets and liabilities of the
acquiree is recognized as goodwill at the date of the business combination. Goodwill arising on the acquisition of subsidiaries is
shown in a separate balance sheet line item, whereas goodwill arising on the acquisition of investments accounted for using the
equity method is recorded in Investments accounted for using the equity method.
Goodwill arising on foreign operations is expressed in the functional currency of the country concerned and translated into euros
using the exchange rate prevailing at the end of the reporting period.
In accordance with IAS 36 (Impairment of Assets), goodwill is carried at cost less accumulated impairment (see Note B.6.).
Goodwill is tested for impairment annually and whenever events or circumstances indicate that impairment might exist. Such
events or circumstances include significant changes more likely than not to have an other-than-temporary impact on the
substance of the original investment.
B.4. Other intangible assets
Other intangible assets are initially measured at acquisition cost or production cost, including any directly attributable costs of
preparing the asset for its intended use, or (in the case of assets acquired in a business combination) at fair value as of the date of
the business combination. Intangible assets are amortized on a straight line basis over their useful lives.
The useful lives of other intangible assets are reviewed at the end of each reporting period. The effect of any adjustment to
useful lives is recognized prospectively as a change in accounting estimate.
Amortization of other intangible assets is recognized in the income statement within Amortization of intangible assets except
for amortization charged against (i) acquired or internally-developed software and (ii) other rights of an industrial or operational
nature, which is recognized in the relevant classification of expense by function.
Sanofi does not own any intangible assets with an indefinite useful life, other than goodwill.
Intangible assets (other than goodwill) are carried at cost less accumulated amortization and accumulated impairment, if any, in
accordance with IAS 36 (see Note B.6.).
B.4.1. Research and development not acquired in a business combination
Internally generated research and development
Under IAS 38, research expenses are recognized in profit or loss when incurred.
Internally generated development expenses are recognized as an intangible asset if, and only if, all the following six criteria can be
demonstrated: (a) the technical feasibility of completing the development project; (b) Sanofi’s intention to complete the project;
(c) Sanofi’s ability to use the project; (d) the probability that the project will generate future economic benefits; (e) the availability
of adequate technical, financial and other resources to complete the project; and (f) the ability to measure the development
expenditure reliably.
Due to the risks and uncertainties relating to regulatory approval and to the research and development process, the six criteria
for capitalization are usually considered not to have been met until the product has obtained marketing approval from the
regulatory authorities. Consequently, internally generated development expenses arising before marketing approval has been
obtained, mainly the cost of clinical studies, are generally expensed as incurred within Research and development expenses.
Some industrial development expenses (such as those incurred in developing a second-generation synthesis process) are
incurred after marketing approval has been obtained, in order to improve the industrial process for an active ingredient. To the
F-14 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
extent that the six IAS 38 criteria are considered as having been met, such expenses are recognized as an asset in the balance
sheet within Other intangible assets as incurred. Similarly, some clinical studies, for example those undertaken to obtain a
geographical extension for a molecule that has already obtained marketing approval in a major market, may in certain
circumstances meet the six capitalization criteria under IAS 38, in which case the related expenses are recognized as an asset in
the balance sheet within Other intangible assets.
Separately acquired research and development
Payments for separately acquired research and development are capitalized within Other intangible assets provided that they
meet the definition of an intangible asset: a resource that is (i) controlled by Sanofi, (ii) expected to provide future economic benefits
for Sanofi, and (iii) identifiable (i.e. it is either separable or arises from contractual or legal rights). Under paragraph 25 of IAS 38, the
first condition for capitalization (the probability that the expected future economic benefits from the asset will flow to the entity) is
considered to be satisfied for separately acquired research and development. Consequently, upfront and milestone payments to
third parties related to pharmaceutical products for which marketing approval has not yet been obtained are recognized as
intangible assets, and amortized on a straight line basis over their useful lives beginning when marketing approval is obtained.
Payments under research and development arrangements relating to access to technology or to databases, and payments made
to purchase generics dossiers, are also capitalized, and amortized over the useful life of the intangible asset.
Subcontracting arrangements, payments for research and development services, and continuous payments under research and
development collaborations which are unrelated to the outcome of that collaboration, are expensed over the service term.
B.4.2. Other intangible assets not acquired in a business combination
Licenses other than those related to pharmaceutical products and research projects, in particular software licenses, are
capitalized at acquisition cost, including any directly attributable cost of preparing the software for its intended use. Software
licenses are amortized on a straight line basis over their useful lives for Sanofi (three to five years ).
Internally generated costs incurred to develop or upgrade software are capitalized if the IAS 38 recognition criteria are satisfied,
and amortized on a straight line basis over the useful life of the software from the date on which the software is ready for use.
B.4.3. Other intangible assets acquired in a business combination
Other intangible assets acquired in a business combination (in-process research and development, technology platforms, and
currently marketed products) that are reliably measurable are identified separately from goodwill, measured at fair value, and
capitalized within Other intangible assets in accordance with IFRS 3 (Business Combinations) and IAS 38 (Intangible Assets). The
related deferred tax liability is also recognized if a deductible or taxable temporary difference exists.
In-process research and development acquired in a business combination is amortized on a straight line basis over its useful life
from the date of receipt of marketing approval.
Rights to technology platforms and to products currently marketed by Sanofi are amortized on a straight line basis over their
useful lives, determined (in particular for marketed products) on the basis of cash flow forecasts which take into account the
patent protection period of the marketed product.
B.5. Property, plant and equipment owned and leased
B.5.1. Property, plant and equipment owned
Property, plant and equipment is initially measured and recognized at acquisition cost, including any directly attributable cost of
preparing the asset for its intended use, or (in the case of assets acquired in a business combination) at fair value as of the date of
the business combination. The component-based approach to accounting for property, plant and equipment is applied. Under
this approach, each component of an item of property, plant and equipment with a cost which is significant in relation to the total
cost of the item and which has a different useful life from the other components must be depreciated separately.
After initial measurement, property, plant and equipment is carried at cost less accumulated depreciation and impairment, except
for land which is carried at cost less impairment.
Subsequent costs are not recognized as assets unless (i) it is probable that future economic benefits associated with those costs
will flow to Sanofi and (ii) the costs can be measured reliably.
Borrowing costs attributable to the financing of items of property, plant and equipment, and incurred during the construction
period, are capitalized as part of the acquisition cost of the item.
Government grants relating to property, plant and equipment are deducted from the acquisition cost of the asset to which
they relate.
The depreciable amount of items of property, plant and equipment, net of any residual value, is depreciated on a straight line
basis over the useful life of the asset. The useful life of an asset is usually equivalent to its economic life.
SANOFI FORM 20-F 2025 | F-15 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
Buildings | |
Fixtures | |
Machinery and equipment | |
Other |
Useful lives and residual values of property, plant and equipment are reviewed annually. The effect of any adjustment to useful
lives or residual values is recognized prospectively as a change in accounting estimate.
Depreciation of property, plant and equipment is recognized as an expense in the income statement, in the relevant classification
of expense by function.
B.5.2. Property, plant and equipment leased
Leases contracted by Sanofi have been accounted for in accordance with IFRS 16 (Leases). Sanofi recognizes a right-of-use asset
and a lease liability for all of its lease contracts, except for (i) leases relating to low-value assets and (ii) short-term leases
(12 months or less). Payments made in respect of leases not recognized on the balance sheet are recognized as an operating
expense on a straight line basis over the lease term.
On commencement of a lease, the liability for future lease payments is discounted at the incremental borrowing rate, which is a
risk-free rate adjusted to reflect the specific risk profile of each Sanofi entity. Because lease payments are spread over the lease
term, Sanofi applies a discount rate based on the duration of those payments.
The payments used to determine the liability for future lease payments exclude non-lease components, but include fixed
payments that Sanofi expects to make to the lessor over the estimated lease term.
After commencement of the lease, the liability for future lease payments is reduced by the amount of the lease payments made,
and increased to reflect interest on the liability. In the event of a reassessment or modification of future lease payments, the lease
liability is remeasured. The right-of-use asset – which is initially measured at cost including direct costs of the lessee,
prepayments made at or prior to the commencement date, less lease incentives received and restoration costs – is depreciated
on a straight line basis over the lease term, and tested for impairment as required.
Sanofi recognizes deferred taxes in respect of right-of-use assets and lease liabilities.
Leasehold improvements are depreciated over their economic life, which is capped at the lease term as determined
under IFRS 16.
F-16 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
B.6. Impairment of property, plant and equipment, intangible assets, and investments
accounted for using the equity method
B.6.1. Impairment of property, plant and equipment and intangible assets
In accordance with IAS 36 (Impairment of Assets), assets that generate separate cash flows and assets included in
cash-generating units (CGUs) are assessed for impairment when events or changes in circumstances indicate that the asset or
CGU may be impaired. A CGU is the smallest identifiable group of assets that generates cash inflows that are largely independent
of the cash inflows from other assets or groups of assets.
Under IAS 36, each CGU or group of CGUs to which goodwill is allocated must (i) represent the lowest level within the entity at
which the goodwill is monitored for internal management purposes, and (ii) not be larger than an operating segment determined
in accordance with IFRS 8 (Operating Segments), before application of the IFRS 8 aggregation criteria (see Note B.26.).
Quantitative and qualitative indications of impairment (primarily relating to the status of the research and development portfolio,
pharmacovigilance, patent litigation, and the launch of competing products) are reviewed at the end of each reporting period. If
there is any internal or external indication of impairment, Sanofi estimates the recoverable amount of the asset or CGU.
Other intangible assets not yet available for use (such as capitalized in-process research and development), and CGUs or groups
of CGUs that include goodwill, are tested for impairment annually whether or not there is any indication of impairment, and more
frequently if any event or circumstance indicates that they might be impaired. Such assets are not amortized.
When there is an internal or external indication of impairment, Sanofi estimates the recoverable amount of the asset and
recognizes an impairment loss if the carrying amount of the asset exceeds its recoverable amount. The recoverable amount of
the asset is the higher of its fair value less costs to sell or its value in use. To determine value in use, Sanofi uses estimates of future
cash flows generated by the asset or CGU, prepared using the same methods as those used in the initial measurement of the
asset or CGU on the basis of medium-term strategic plans.
In the case of goodwill, estimates of future cash flows are based on a five-year strategic plan, an extrapolation of the cash flows
over a further five-year period, and a terminal value. In the case of other intangible assets, the period used is based on the
economic life of the asset.
Estimated cash flows are discounted at long-term market interest rates that reflect the best estimate by Sanofi of the time value
of money, the risks specific to the asset or CGU, and economic conditions in the geographical regions in which the business
activity associated with the asset or CGU is located.
Certain assets and liabilities that are not directly attributable to a specific CGU are allocated between CGUs on a basis that is
reasonable, and consistent with the allocation of the corresponding goodwill.
Impairment losses arising on property, plant and equipment, software and certain rights, are recognized within the appropriate
income statement line item according to the origin of the impairment.
Impairment losses arising on other intangible assets (products, trademarks, technology platforms, acquired R&D) are recognized
within Impairment of intangible assets in the income statement.
B.6.2. Impairment of investments accounted for using the equity method
In accordance with IAS 28 (Investments in Associates and Joint Ventures), Sanofi determines whether investments accounted for
using the equity method may be impaired based on indicators such as default in contractual payments, significant financial
difficulties, probability of bankruptcy, or a prolonged or significant decline in quoted market price. If an investment is impaired,
the amount of the impairment loss is determined by applying IAS 36 (see Note B.6.1.) and recognized in Share of profit/(loss)
from investments accounted for using the equity method.
B.6.3. Reversals of impairment losses charged against property, plant and equipment,
intangible assets, and investments accounted for using the equity method
At the end of each reporting period, Sanofi assesses whether events or changes in circumstances indicate that an impairment
loss recognized in a prior period in respect of an asset (other than goodwill) or an investment accounted for using the equity
method can be reversed. If this is the case, and the recoverable amount as determined based on the revised estimates exceeds
the carrying amount of the asset, Sanofi reverses the impairment loss only to the extent of the carrying amount that would have
been determined had no impairment loss been recognized for the asset.
Reversals of impairment losses in respect of other intangible assets are recognized within the income statement line item
Impairment of intangible assets, while reversals of impairment losses in respect of investments accounted for using the equity
method are recognized within the income statement line item Share of profit/(loss) from investments accounted for using the
equity method. Impairment losses taken against goodwill are never reversed, unless the goodwill is part of the carrying amount
of an investment accounted for using the equity method.
SANOFI FORM 20-F 2025 | F-17 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
B.7. Assets held for sale and liabilities related to assets held for sale and
discontinued operations
In accordance with IFRS 5 (Non-Current Assets Held for sale and Discontinued Operations), non-current assets and groups of
assets are classified as held for sale in the balance sheet if their carrying amount will be recovered principally through a sale
transaction rather than through continuing use. Within the meaning of IFRS 5, the term “sale” also includes exchanges for other
assets.
Non-current assets or asset groups held for sale must be available for immediate sale in their present condition, subject only to
terms that are usual and customary for sales of such assets, and a sale must be highly probable. Criteria used to determine
whether a sale is highly probable include:
•the appropriate level of management must be committed to a plan to sell;
•an active program to locate a buyer and complete the plan must have been initiated;
•the asset must be actively marketed for sale at a price that is reasonable in relation to its current fair value;
•completion of the sale should be foreseeable within the 12 months following the date of reclassification to Assets held for
sale; and
•actions required to complete the plan should indicate that it is unlikely that significant changes to the plan will be made or that
the plan will be withdrawn.
Before initial reclassification of the non-current asset (or asset group) to Assets held for sale, the carrying amounts of the asset
(or of all the assets and liabilities in the asset group) must be measured in accordance with the applicable standards.
Subsequent to reclassification to Assets held for sale, the non-current asset (or asset group) is measured at the lower of carrying
amount or fair value less costs to sell, with any write-down recognized by means of an impairment loss. Once a non-current asset
has been reclassified as held for sale or exchange, it is no longer depreciated or amortized.
From the date of reclassification:
•property, plant and equipment, right-of-use assets and intangible assets are no longer subject to individual depreciation,
amortization or impairment; and
•the share of profits and losses from investments accounted for using the equity method is no longer recognized.
In a disposal of an equity interest leading to loss of control, all the assets and liabilities of the entity involved are classified as held
for sale assets or liabilities within the balance sheet line items Assets held for sale or Liabilities related to assets held for sale,
provided that the disposal satisfies the IFRS 5 classification criteria.
The profit or loss generated by a held for sale asset group is reported in a separate line item in the income statement for the
current period and for the comparative periods presented, provided that the asset group:
•represents a separate major line of business or geographical area of operations; or
•is part of a single coordinated plan to dispose of a separate major line of business or geographical area of operations; or
•is a subsidiary acquired exclusively with a view to resale.
In accordance with IFRS 10, intragroup balances and transactions relating to held for sale entities are eliminated.
In the absence of any specific accounting treatment under IFRS 5, Sanofi has opted to eliminate transactions between
discontinued operations and continuing operations so as to reflect the impact of such transactions consistently with the way
they are presented in the income statement after effective loss of control.
Events or circumstances beyond Sanofi’s control may extend the period to complete the sale or exchange beyond one year
without precluding classification of the asset (or disposal group) in Assets held for sale provided that there is sufficient evidence
that Sanofi remains committed to the planned sale or exchange. Finally, in the event of changes to a plan of sale that requires an
asset no longer to be classified as held for sale, IFRS 5 specifies the following treatment:
•the assets and liabilities previously classified as held for sale are reclassified to the appropriate balance sheet line items, with
no restatement of comparative periods;
•each asset is measured at the lower of (a) its carrying amount before the asset was reclassified as held for sale, adjusted for
any depreciation, amortization or revaluation that would have been recognized if the asset had not been reclassified as held
for sale, or (b) its recoverable amount at the date of reclassification;
•the backlog of depreciation, amortization and impairment not recognized while non-current assets were classified as held for
sale must be reported in the same income statement line item that was used to report impairment losses arising on initial
reclassification of assets as held for sale and gains or losses arising on the sale of such assets. In the consolidated income
statement, those impacts are reported within the line item Other gains and losses, and litigation;
•the net income of a business previously classified as discontinued or as held for sale or exchange and reported on a separate
line in the income statement must be reclassified and included in net income from continuing operations, for all periods
presented; and
•in addition, segment information relating to the income statement and the statement of cash flows (acquisitions of
non-current assets) must be disclosed in the notes to the financial statements in accordance with IFRS 8 (Operating
Segments), and must also be restated for all prior periods presented.
F-18 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
B.8. Financial instruments
B.8.1. Non-derivative financial assets
In accordance with IFRS 9 (Financial Instruments) and IAS 32 (Financial Instruments: Presentation), Sanofi has adopted the
classification of non-derivative financial assets described below. The classification used depends on (i) the characteristics of the
contractual cash flows (i.e. whether they represent interest or principal) and (ii) the business model for managing the asset
applied at the time of initial recognition.
Financial assets at fair value through other comprehensive income
These mainly comprise:
•quoted and unquoted equity investments that Sanofi does not hold for trading purposes and that management has
designated at “fair value through other comprehensive income” on initial recognition. Gains and losses arising from changes in
fair value are recognized in equity within the statement of comprehensive income in the period in which they occur. When
such instruments are derecognized, the previously-recognized changes in fair value remain within Other comprehensive
income, as does the gain or loss on divestment. Dividends received are recognized in profit or loss for the period, within the
line item Financial income; and
•debt instruments whose contractual cash flows represent payments of interest or repayments of principal, and which are
managed with a view to collecting cash flows and selling the asset. Gains and losses arising from changes in fair value are
recognized in equity within the statement of comprehensive income in the period in which they occur. When such assets are
derecognized, the cumulative gains and losses previously recognized in equity are reclassified to profit or loss for the period
within the line items Financial income or Financial expenses.
Financial assets at fair value through profit or loss
These mainly comprise:
•contingent consideration receivable already carried in the books of an acquired entity or granted in connection with a
business combination;
•instruments whose contractual cash flows represent payments of interest and repayments of principal, which are managed
with a view to selling the asset in the short term;
•instruments that management has designated at “fair value through profit or loss” on initial recognition; and
•quoted and unquoted equity investments: equity instruments that are not held for trading and which management did not
designate at “fair value through other comprehensive income” on initial recognition, and instruments that do not meet the
IFRS definition of “equity instruments”.
Gains and losses arising from changes in fair value are recognized in profit or loss within the line items Financial income or
Financial expenses. Dividends received are recognized in profit or loss for the period, within the line item Financial income.
Fair value of equity investments in unquoted entities
On initial recognition of an equity investment in an entity not quoted in an active market, the fair value of the investment is the
transaction price except in specific circumstances. This acquisition cost ceases to be a representative measure of the fair value of
an unquoted equity investment when Sanofi identifies significant changes in the investee, or in the environment in which it
operates. In such cases, an internal valuation is carried out, based mainly on growth forecasts or by reference to similar
transactions contracted with third parties.
Financial assets measured at amortized cost
Financial assets at amortized cost comprise instruments whose contractual cash flows represent payments of interest and
repayments of principal and which are managed with a view to collecting cash flows. The main assets in this category are loans
and receivables. They are presented within the line items Other non-current assets, Other current assets, Accounts receivable
and Cash and cash equivalents. Loans with a maturity of more than 12 months are presented in “Long-term loans and
advances” within Other non-current assets. These financial assets are measured at amortized cost using the effective interest
method.
Impairment of financial assets measured at amortized cost
The main assets involved are accounts receivable. Accounts receivable are initially recognized at the amount invoiced to the
customer. Impairment losses on trade accounts receivable are estimated using the expected credit loss method, in order to take
account of the risk of payment default throughout the lifetime of the receivables. The expected credit loss is estimated
collectively for all accounts receivable at each reporting date using an average expected loss rate, determined primarily on the
basis of historical credit loss rates. However, that average expected loss rate may be adjusted if there are indications of a likely
significant increase in credit risk. If a receivable is subject to a known credit risk, a specific impairment loss is recognized for that
receivable. The amount of expected losses is recognized in the balance sheet as a reduction in the gross amount of accounts
receivable. Impairment losses on accounts receivable are recognized within Selling and general expenses in the income
statement.
SANOFI FORM 20-F 2025 | F-19 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
B.8.2. Derivative instruments
Derivative instruments that do not qualify for hedge accounting are initially and subsequently measured at fair value, with
changes in fair value recognized in the income statement in Other operating income or in Financial income or Financial
expenses, depending on the nature of the underlying economic item which is hedged.
Derivative instruments that qualify for hedge accounting are measured using the policies described in Note B.8.3. below.
IFRS 13 (Fair Value Measurement) requires counterparty credit risk to be taken into account when measuring the fair value of
financial instruments. That risk is estimated on the basis of observable, publicly-available statistical data.
Policy on offsetting
In order for a financial asset and a financial liability to be presented as a net amount in the balance sheet under IAS 32, there must
be:
(a) a legally enforceable right to offset; and
(b) the intention either to settle on a net basis, or to realize the asset and settle the liability simultaneously.
B.8.3. Hedging
As part of its overall market risk management policy, Sanofi enters into various hedging transactions involving derivative or
non-derivative instruments; these may include forward contracts, currency swaps or options, interest rate swaps or options,
cross-currency swaps, and debt placings or issues.
Such financial instruments are designated as hedging instruments and recognized using the hedge accounting principles
of IFRS 9 when (a) there is formal designation and documentation of the hedging relationship, of how the effectiveness of the
hedging relationship will be assessed, and of the underlying market risk management objective and strategy; (b) the hedged item
and the hedging instrument are eligible for hedge accounting; and (c) there is an economic relationship between the hedged
item and the hedging instrument, defined on the basis of a hedge ratio that is consistent with the underlying market risk
management strategy, and the residual credit risk does not dominate the value changes that result from that economic
relationship.
Fair value hedge
A fair value hedge is a hedge of the exposure to changes in fair value of an asset, liability or firm commitment that is attributable
to one or more risk components and could affect profit or loss.
Changes in fair value of the hedging instrument and changes in fair value of the hedged item attributable to the hedged risk
components are generally recognized in the income statement, within Other operating income for hedges related to operating
activities, or within Financial income or Financial expenses for hedges related to investing or financing activities.
Cash flow hedge
A cash flow hedge is a hedge of the exposure to variability in cash flows from an asset, liability or highly probable forecast
transaction that is attributable to one or more risk components and could affect profit or loss.
Changes in fair value of the hedging instrument attributable to the effective portion of the hedge are recognized directly in
equity in the consolidated statement of comprehensive income. Changes in fair value attributable to the ineffective portion of
the hedge are recognized in the income statement within Other operating income for hedges related to operating activities, and
within Financial income or Financial expenses for hedges related to investing or financing activities.
Cumulative changes in fair value of the hedging instrument previously recognized in equity are reclassified to the income
statement when the hedged transaction affects profit or loss. Those reclassified gains and losses are recognized within Other
operating income for hedges related to operating activities, and within Financial income or Financial expenses for hedges
related to investing or financing activities.
When a forecast transaction results in the recognition of a non-financial asset or liability, cumulative changes in the fair value of
the hedging instrument previously recognized in equity are incorporated in the initial carrying amount of that asset or liability.
When the hedging instrument expires or is sold, terminated or exercised, the cumulative gain or loss previously recognized in
equity remains separately recognized in equity and is not reclassified to the income statement, or recognized as an adjustment to
the initial cost of the related non-financial asset or liability, until the forecast transaction occurs. However, if Sanofi no longer
expects the forecast transaction to occur, the cumulative gain or loss previously recognized in equity is recognized immediately
in profit or loss.
Hedge of a net investment in a foreign operation
In a hedge of a net investment in a foreign operation, changes in the fair value of the hedging instrument attributable to the
effective portion of the hedge are recognized directly in equity in the consolidated statement of comprehensive income.
Changes in fair value attributable to the ineffective portion of the hedge are recognized in the income statement within
Financial income or Financial expenses. When the investment in the foreign operation is sold, the changes in the fair value of
the hedging instrument previously recognized in equity are reclassified to the income statement within Financial income or
Financial expenses.
F-20 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
Cost of hedging
As part of its market risk management policy, Sanofi may designate currency options or interest rate options as hedging
instruments, the effectiveness of which is measured on the basis of changes in intrinsic value. In such cases, the time value of the
option is treated as a hedging cost and accounted for as follows:
•if the option includes a component that is not aligned on the critical features of the hedged item, the corresponding change in
the time value is taken to profit or loss;
•otherwise, the change in the time value is taken to equity within the statement of comprehensive income, and then:
–if the hedged item is linked to a transaction that results in the recognition of a financial asset or liability, the change in the
time value is reclassified to profit or loss symmetrically with the hedged item, or
–if the hedged item is linked to a transaction that results in the recognition of a non-financial asset or liability, the change in
the time value is incorporated in the initial carrying amount of that asset or liability, or
–if the hedged item is linked to a period of time, the change in time value is reclassified to profit or loss on a straight line basis
over the life of the hedging relationship.
In the case of forward contracts and foreign exchange swaps, and of cross-currency swaps that qualify for hedge accounting on
the basis of changes in spot rates, Sanofi may elect for each transaction to use the option whereby the premium/discount or
foreign currency basis spread are treated in the same way as the time value of an option.
Discontinuation of hedge accounting
Hedge accounting is discontinued when the eligibility criteria are no longer met (in particular, when the hedging instrument
expires or is sold, terminated or exercised), or if there is a change in the market risk management objective of the hedging
relationship.
B.8.4. Non-derivative financial liabilities
Borrowings and debt
Bank borrowings and debt instruments are initially measured at fair value of the consideration received, net of directly
attributable transaction costs.
Subsequently, they are measured at amortized cost using the effective interest method. All costs related to the issuance of
borrowings or debt instruments, and all differences between the issue proceeds net of transaction costs and the value on
redemption, are recognized within Financial expenses in the income statement over the term of the debt using the effective
interest method.
Liabilities related to business combinations and to non-controlling interests
These line items record the fair value of (i) contingent consideration payable in connection with business combinations and
(ii) commitments to buy out equity holders of subsidiaries, including put options granted to non-controlling interests.
Adjustments to the fair value of commitments to buy out equity holders of subsidiaries, including put options granted to
non-controlling interests, are recognized in equity.
Other non-derivative financial liabilities
Other non-derivative financial liabilities include trade accounts payable, which are measured at fair value (which in most cases
equates to face value) on initial recognition, and subsequently at amortized cost.
B.8.5. Fair value of financial instruments
Under IFRS 13 (Fair Value Measurement) and IFRS 7 (Financial Instruments: Disclosures), fair value measurements must be
classified using a hierarchy based on the inputs used to measure the fair value of the instrument. This hierarchy has three levels:
a.level 1: quoted prices in active markets for identical assets or liabilities (without modification or repackaging);
b.level 2: quoted prices in active markets for similar assets and liabilities, or valuation techniques in which all important inputs are
derived from observable market data; and
c.level 3: valuation techniques in which not all important inputs are derived from observable market data.
SANOFI FORM 20-F 2025 | F-21 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
instruments.
Note | Type of financial instrument | Measurement principle | Level in fair value hierarchy | Valuation technique | Method used to determine fair value | ||
Valuation model | Market data | ||||||
Exchange rate | Interest rate | ||||||
D.7. | Financial assets measured at fair value (quoted equity instruments) | Fair value | 1 | Market value | Quoted market price | N/A | |
D.7. | Financial assets measured at fair value (quoted debt instruments) | Fair value | 1 | Market value | Quoted market price | N/A | |
D.7. | Financial assets measured at fair value (unquoted equity instruments) | Fair value | 3 | Cost/ Approach based on comparables | If cost ceases to be a representative measure of fair value, an internal valuation is carried out, based mainly on comparables. | ||
D.7. | Financial assets measured at fair value (contingent consideration receivable) | Fair value | 3 | Revenue- based approach | The fair value of contingent consideration receivable is determined by adjusting the contingent consideration at the end of the reporting period using the method described in Note D.7.3. | ||
D.7. | Financial assets measured at fair value held to meet obligations under post-employment benefit plans | Fair value | 1 | Market value | Quoted market price | N/A | |
D.7. | Financial assets designated at fair value held to meet obligations under deferred compensation plans | Fair value | 1 | Market value | Quoted market price | N/A | |
D.7. | Long-term loans and advances and other non-current receivables | Amortized cost | N/A | N/A | The amortized cost of long-term loans and advances and other non-current receivables at the end of the reporting period is not materially different from their fair value. | ||
D.13. | Investments in mutual funds | Fair value | 1 | Market value | Net asset value | N/A | |
D.13. | Negotiable debt instruments, commercial paper, instant access deposits and term deposits | Amortized cost | N/A | N/A | Because these instruments have a maturity of less than three months, amortized cost is regarded as an acceptable approximation of fair value as disclosed in the notes to the consolidated financial statements. | ||
D.17.1., D.19. | Debt | Amortized cost(a) | N/A | N/A | In the case of debt with a maturity of less than three months, amortized cost is regarded as an acceptable approximation of fair value as reported in the notes to the consolidated financial statements. For debt with a maturity of more than three months, fair value as reported in the notes to the consolidated financial statements is determined either by reference to quoted market prices at the end of the reporting period (quoted instruments) or by discounting the future cash flows based on observable market data at the end of the reporting period (unquoted instruments). For financial liabilities based on variable payments such as royalties, fair value is determined on the basis of discounted cash flow projections. | ||
D.17.2. | Lease liabilities | Amortized cost | N/A | N/A | The liability for future lease payments is discounted using the incremental borrowing rate. | ||
D.20. | Forward currency contracts | Fair value | 2 | Present value of future cash flows | Mid Market | < 1 year: Mid Money Market > 1 year: Mid Zero Coupon | |
D.20. | Interest rate swaps | Fair value | 2 | Revenue- based approach | Present value of future cash flows | Mid Market Spot | < 1 year: Mid Money Market and LIFFE interest rate futures > 1 year: Mid Zero Coupon |
D.20. | Cross-currency swaps | Fair value | 2 | Present value of future cash flows | Mid Market Spot | < 1 year: Mid Money Market and LIFFE interest rate futures > 1 year: Mid Zero Coupon | |
D.18. | Liabilities related to business combinations and to non-controlling interests (CVRs) | Fair value | 1 | Market value | Quoted market price | ||
D.18. | Liabilities related to business combinations and to non-controlling interests (other than CVRs) | Fair value | 3 | Revenue- based approach | Under IAS 32, contingent consideration payable in a business combination is a financial liability. The fair value of such liabilities is determined by adjusting the contingent consideration at the end of the reporting period using the method described in Note B.8.4. | ||
(a)In the case of debt designated as a hedged item in a fair value hedging relationship, the carrying amount in the consolidated balance sheet includes
changes in fair value attributable to the hedged risk(s).
F-22 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
B.8.6. Derecognition of financial instruments
Financial assets are derecognized when the contractual rights to cash flows from the asset have ended or have been transferred
and when Sanofi has transferred substantially all the risks and rewards of ownership of the asset. If Sanofi has neither transferred
nor retained substantially all the risks and rewards of ownership of a financial asset, it is derecognized if Sanofi does not retain
control of the asset.
A financial liability is derecognized when Sanofi’s contractual obligations in respect of the liability are discharged, cancelled or
extinguished.
B.8.7. Risks relating to financial instruments
Market risks in respect of non-current financial assets, cash equivalents, derivative instruments and debt are described in the
discussions of risk factors presented in “Item 3. Key Information — D. Risk factors” and “Item 11. Quantitative and Qualitative
Disclosures about Market Risk” of Sanofi’s annual report on Form 20-F for 2025.
Credit risk is the risk that customers may fail to pay their debts. For a description of credit risk, refer to “We are subject to the risk
of non-payment by our customers” within “Item 3. Key Information — D. Risk factors” and “Item 11. Quantitative and Qualitative
Disclosures about Market Risk” of Sanofi’s annual report on Form 20-F for 2025.
B.9. Inventories
Inventories are measured at the lower of cost or net realizable value. Cost is calculated using the weighted average cost method
or the first-in, first-out method, depending on the nature of the inventory.
The cost of finished goods inventories includes costs of purchase, costs of conversion and other costs incurred in bringing the
inventories to their present location and condition.
Net realizable value is the estimated selling price in the ordinary course of business less the estimated costs of completion and
the estimated costs necessary to make the sale.
During the launch phase of a new product, any inventories of that product are written down to zero pending regulatory approval,
other than in specific circumstances which make it possible to estimate that there is a high probability at the end of the reporting
period that the carrying amount of the inventories will be recoverable. The write-down is reversed once it becomes highly
probable that marketing approval will be obtained.
B.10. Cash and cash equivalents
Cash and cash equivalents as shown in the consolidated balance sheet and statement of cash flows comprise cash, plus liquid
short-term investments that are readily convertible into cash and are subject to an insignificant risk of changes in value in the
event of movements in interest rates.
B.11. Treasury shares
In accordance with IAS 32, Sanofi treasury shares are deducted from equity, irrespective of the purpose for which they are held.
B.12. Provisions for risks
In accordance with IAS 37 (Provisions, Contingent Liabilities and Contingent Assets), Sanofi records a provision when it has a
present obligation, whether legal or constructive, as a result of a past event; it is probable that an outflow of resources
embodying economic benefits will be required to settle the obligation; and a reliable estimate can be made of the amount of the
outflow of resources.
If the obligation is expected to be settled more than 12 months after the end of the reporting period, or has no definite settlement
date, the provision is recorded within Non-current provisions and other non-current liabilities.
Provisions relating to the insurance programs in which Sanofi’s captive insurance company participates are based on risk
exposure estimates calculated by management, with assistance from independent actuaries, using IBNR (Incurred But Not
Reported) techniques. Those techniques use past claims experience, within Sanofi and in the market, to estimate future trends in
the cost of claims.
Contingent liabilities are not recognized, but are disclosed in the notes to the financial statements unless the possibility of an
outflow of economic resources is remote.
Sanofi estimates provisions on the basis of events and circumstances related to present obligations at the end of the reporting
period and of past experience, and to the best of management’s knowledge at the date of preparation of the financial
statements.
Reimbursements offsetting the probable outflow of resources are recognized as assets only if it is virtually certain that they will
be received. Contingent assets are not recognized.
Restructuring provisions are recognized if Sanofi has a detailed, formal restructuring plan at the end of the reporting period and
has announced its intention to implement this plan to those affected by it.
SANOFI FORM 20-F 2025 | F-23 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
Sanofi records non-current provisions for certain obligations, such as legal or constructive obligations, where an outflow of
resources is probable and the amount of the outflow can be reliably estimated.
In the case of environmental risks, including at sites where operations are ongoing, Sanofi recognizes a provision where there is a
violation of integrity in respect of human health or the environment resulting from past contamination at a site that requires
remediation. The amount of the provision is a best estimate of the future expenditures to be incurred on the remediation plan.
Where the effect of the time value of money is material, those provisions are measured at the present value of the expenditures
expected to be required to settle the obligation, calculated using a discount rate that reflects an estimate of the time value of
money and the risk specific to the obligation.
Increases in provisions to reflect the effects of the passage of time are recognized within Financial expenses.
B.13. Revenue recognition
B.13.1. Net sales
Revenue arising from the sale of goods is presented in the income statement within Net sales. Net sales comprise revenue from
sales of medicines, vaccines and active ingredients, net of sales returns, of customer incentives and discounts, and of certain
sales-based payments paid or payable to the healthcare authorities. Analysis of net sales are provided in Note D.34.1. “ Analysis of
net sales”.
In accordance with IFRS 15 (Revenue from Contracts with Customers), such revenue is recognized when Sanofi transfers control
over the product to the customer; control of an asset refers to the ability to direct the use of, and obtain substantially all of the
remaining benefits from that asset. For the vast majority of contracts, revenue is recognized when the product is physically
transferred, in accordance with the delivery and acceptance terms agreed with the customer.
For contracts entered into by Vaccines franchise, transfer of control is usually determined by reference to the terms of release
(immediate or deferred) and acceptance of batches of vaccine.
In the case of contracts with distributors, Sanofi does not recognize revenue when the product is physically transferred to the
distributor if the products are sold on consignment, or if the distributor acts as an agent. In such cases, revenue is recognized
when control is transferred to the end customer, and the distributor’s commission is presented within the line item Selling and
general expenses in the income statement.
The amount of revenue recognized reflects the various types of price reductions or rights of return offered by Sanofi to its
customers on certain products. Such price reductions and rights of return qualify as variable consideration under IFRS 15.
In particular, products sold in the United States are covered by various Government and State programs (such as Medicare and
Medicaid) under which products are sold at a discount. Rebates are granted to healthcare authorities, and under contractual
arrangements with certain customers. Some wholesalers are entitled to chargeback incentives based on the selling price to the
end customer, under specific contractual arrangements. Cash discounts may also be granted for prompt payment. Returns,
discounts, incentives and rebates, as described above, are recognized in the period in which the underlying sales are recognized
as a reduction of gross sales.
These amounts are calculated as follows:
•the amount of chargeback incentives is estimated on the basis of the relevant subsidiary’s standard sales terms and
conditions, and in certain cases on the basis of specific contractual arrangements with the customer;
•the amount of rebates based on attainment of sales targets is estimated and accrued as each of the underlying sales
transactions is recognized;
•the amount of price reductions under Government and State programs, largely in the United States, is estimated on the basis
of the specific terms of the relevant regulations or agreements, and accrued as each of the underlying sales transactions is
recognized; and
•the amount of sales returns is calculated on the basis of management’s best estimate of the amount of product that will
ultimately be returned by customers. In countries where product returns are permitted, Sanofi operates a returns policy that
allows the customer to return products within a certain period either side of the expiry date (usually 12 months after the expiry
date). The amount recognized for returns is estimated on the basis of past experience of sales returns. Sanofi also takes into
account factors such as levels of inventory in its various distribution channels, product expiry dates, information about
potential discontinuation of products, the entry of competing generics into the market, and the launch of over-the-counter
medicines. Most product return clauses relate solely to date-expired products, which cannot be resold and are destroyed.
Sanofi does not recognize a right of return asset in the balance sheet for contracts that allow for the return of time-expired
products, since those products have no value.
F-24 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
The estimated amounts described above are recognized in the income statement within Net sales as a reduction of gross sales,
and within Other current liabilities in the balance sheet. They are subject to regular review and adjustment as appropriate based
on the most recent data available to management. Sanofi believes that it has the ability to measure each of the above amounts
reliably, using the following factors in developing its estimates:
•the nature and patient profile of the underlying product;
•the applicable regulations or the specific terms and conditions of contracts with governmental authorities, payers, wholesalers
and other customers;
•historical data relating to similar contracts, in the case of qualitative and quantitative rebates and chargeback incentives;
•past experience and sales growth trends for the same or similar products;
•actual inventory levels in distribution channels, monitored by Sanofi using internal sales data and externally provided data;
•the shelf life of Sanofi products; and
•market trends including competition, pricing and demand.
An analysis of provisions for discounts, rebates and sales returns is provided in Note D.23.
B.13.2. Other revenues
The line item Other revenues is used to recognize all revenue that falls within the scope of IFRS 15 but does not relate to sales of
Sanofi products.
It mainly comprises (i) royalties received from licensing intellectual property rights to third parties; (ii) VaxServe sales of products
sourced from third-party manufacturers; and (iii) revenue received under agreements for Sanofi to provide manufacturing
services to third parties.
Royalties received under licensing arrangements are recognized over the period during which the underlying sales are
recognized.
VaxServe is a vaccine-related entity whose operations include the distribution within the US of vaccines and other products
manufactured by third parties. VaxServe sales of products sourced from third-party manufacturers are presented within Other
revenues.
Other revenues is also used to recognize revenues generated from the manufacturing of Consumer Healthcare products on
behalf of Opella entities. Until April 30, 2025, Opella entities were within the scope of discontinued operations (see Note B.7.).
With effect from May 1, 2025, Opella entities are treated as related parties in accordance with IAS 24 (see Note D.6.).
In addition, Other revenues includes revenues associated with Consumer Healthcare operations not transferred on the effective
date of loss of control of Opella. These comprise primarily, but not exclusively, Consumer Healthcare activities that were not
transferred on the effective date of loss of control of Opella, primarily (i) hospital sales of Opella products in China, the transfer of
which will be finalized no earlier than 2028 after a transitional period required to complete the transfer plan agreed with Sanofi in
the context of public tendering arrangements; (ii) sales made by the dedicated entity Opella Russie, of which Sanofi continues to
hold the capital (Sanofi is continuing to distribute Opella products in Russian territory under a distribution agreement signed in
connection with the separation, the parties reserving the right to discuss the transfer of that entity during the term of the
distribution agreement); and (iii) sales of the Gold Bond product range, which are continuing in the US through the retained
subsidiary Gold Bond LLC (holder of the associated worldwide property rights).
B.14. Cost of sales
Cost of sales consists primarily of the industrial cost of goods sold, royalties paid for in-licensing of intellectual property, and
distribution costs. The industrial cost of goods sold includes the cost of materials, depreciation of property, plant and equipment,
amortization of software, personnel costs, and other expenses attributable to production. This line also includes the purchase
price of manufactured pharmaceutical products sourced from Opella.
B.15. Research and development
Note B.4.1. “Research and development not acquired in a business combination” and Note B.4.3. “Other intangible assets
acquired in a business combination” describe the principles applied to the recognition of research and development costs.
Contributions or reimbursements received from alliance partners are recorded as a reduction of Research and development
expenses.
SANOFI FORM 20-F 2025 | F-25 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
B.16. Other operating income and expenses
B.16.1. Other operating income
Other operating income includes the share of profits that Sanofi is entitled to receive from alliance partners in respect of
product marketing agreements. It also includes revenues generated under certain agreements, which may include partnership,
co-promotion arrangements and licenses not included in Other revenues.
This line item also includes realized and unrealized foreign exchange gains and losses on operating activities (see Note B.8.3.), and
operating gains on disposals not regarded as major disposals (see Note B.20.).
B.16.2. Other operating expenses
Other operating expenses mainly comprise the share of profits that alliance partners are entitled to receive from Sanofi under
product marketing agreements.
B.17. Amortization and impairment of intangible assets
B.17.1. Amortization of intangible assets
The expenses recorded in this line item comprise amortization charged against intangible assets (products, trademarks and
technology platforms, see Note D.4.) whose contribution to Sanofi’s commercial, industrial and development functions cannot be
separately identified.
Amortization of software, and of other rights of an industrial or operational nature, is recognized as an expense in the income
statement, in the relevant line items of expense by function.
B.17.2. Impairment of intangible assets
This line item records impairment losses taken against intangible assets (products, trademarks, technology platforms and
acquired research), and any reversals of such impairment losses.
B.18. Fair value remeasurement of contingent consideration
Changes in the fair value of contingent consideration that was (i) already carried in the books of an acquired entity, or (ii) granted
in connection with a business combination and initially recognized as a liability in accordance with IFRS 3, are reported in profit or
loss. Such adjustments are reported separately in the income statement, in the line item Fair value remeasurement of
contingent consideration.
This line item also includes changes in the fair value of contingent consideration receivable in connection with a divestment and
classified as a financial asset at fair value through profit or loss.
Finally, it includes the effect of the unwinding of discount, and of exchange rate movements where the asset or liability is
expressed in a currency other than the functional currency of the reporting entity.
B.19. Restructuring costs and similar items
Restructuring costs are expenses incurred in connection with the transformation or reorganization of Sanofi’s operations or support
functions. Such costs include collective redundancy plans, compensation to third parties for early termination of contracts, and
commitments made in connection with transformation or reorganization decisions. They also include accelerated depreciation
charges arising from site closures (including closures of leased sites), and losses on asset disposals resulting from such decisions.
In addition, this line item includes (i) expenses incurred in connection with programs implemented as part of the transformation
strategy announced in December 2019 and recently renewed in October 2023, and intended primarily to deliver a global
information systems solution, further supported by the implementation from 2021 of Sanofi’s new digital strategy; and
(ii) transaction, integration and separation costs in connection with material acquisitions or divestitures.
B.20. Other gains and losses, and litigation
The line item Other gains and losses, and litigation includes the impact of material transactions of an unusual nature or amount
which Sanofi believes it necessary to report separately in the income statement in order to improve the relevance of the financial
statements, such as:
•gains and losses on major disposals of property, plant and equipment, of intangible assets, of assets (or groups of assets and
liabilities) held for sale, or of a business within the meaning of IFRS 3, other than those considered to be restructuring costs;
•impairment losses and reversals of impairment losses on assets (or groups of assets and liabilities) held for sale, other than
those considered to be restructuring costs;
•gains on bargain purchases;
•costs relating to major litigation; and
•pre-tax separation costs associated with the process of divestment from operations in the event of a major divestment.
F-26 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
B.21. Financial expenses and income
B.21.1. Financial expenses
Financial expenses mainly comprise interest charges on Sanofi's debt financing; negative changes in the fair value of certain
financial instruments (where changes in fair value are recognized in profit or loss); realized and unrealized foreign exchange losses
on financing and investing activities; impairment losses on financial instruments; and any reversals of impairment losses on
financial instruments.
Financial expenses also include expenses arising from the unwinding of discount on long-term provisions, and the net interest
cost related to employee benefits. This line item does not include commercial cash discounts, which are deducted from net sales.
B.21.2. Financial income
Financial income includes interest and dividend income; positive changes in the fair value of certain financial instruments (where
changes in fair value are recognized in profit or loss); realized and unrealized foreign exchange gains on financing and investing
activities; and gains on disposals of financial assets at fair value through profit or loss.
B.22. Income tax expense
Income tax expense includes all current and deferred taxes of consolidated companies.
Sanofi accounts for deferred taxes in accordance with IAS 12 (Income Taxes), using the methods described below:
•deferred tax assets and liabilities are recognized on taxable and deductible temporary differences, and on tax loss
carry-forwards. Temporary differences are differences between the carrying amount of an asset or liability in the balance
sheet and its tax base;
•French business taxes include a value added based component: “CVAE” (Cotisation sur la Valeur Ajoutée des Entreprises).
Given that CVAE is (i) calculated as the amount by which certain revenues exceed certain expenses and (ii) borne primarily by
companies that own intellectual property rights on income derived from those rights (royalties, and margin on sales to third
parties and to Sanofi entities), it is regarded as meeting the definition of income taxes specified in IAS 12, paragraph 2 (“taxes
which are based on taxable profits”);
•deferred tax assets and liabilities are calculated using the tax rate expected to apply in the period when the corresponding
temporary differences are expected to reverse, based on tax rates enacted or substantively enacted at the end of the
reporting period;
•deferred tax assets are recognized in respect of deductible temporary differences, tax losses available for carry-forward and
unused tax credits to the extent that future recovery is regarded as probable. The recoverability of deferred tax assets is
assessed on a case-by-case basis, taking into account the profit forecasts contained in Sanofi’s medium-term business plan;
•a deferred tax liability is recognized for temporary differences relating to interests in subsidiaries, associates and joint
ventures, except in cases where Sanofi is able to control the timing of the reversal of the temporary differences. This applies in
particular when Sanofi is able to control dividend policy and it is probable that the temporary differences will not reverse in the
foreseeable future;
•no deferred tax is recognized on eliminations of intragroup transfers of interests in subsidiaries, associates or joint ventures;
•each tax entity calculates its own net deferred tax position. All net deferred tax asset and liability positions are then
aggregated and shown in separate line items on the relevant side of the consolidated balance sheet. Deferred tax assets and
liabilities are offset only if (i) Sanofi has a legally enforceable right to offset current tax assets and current tax liabilities, and
(ii) the deferred tax assets and deferred tax liabilities relate to income taxes levied by the same taxation authority;
•deferred taxes are not discounted, except implicitly in the case of deferred taxes on assets and liabilities which are already
impacted by discounting. In addition, Sanofi has elected not to discount current taxes payable or receivable where the
amounts in question are payable or receivable in the long term; and
•withholding taxes on intragroup royalties and dividends, and on royalties and dividends collected from third parties, are
accounted for as current income taxes.
In accounting for business combinations, Sanofi complies with IFRS 3 as regards the recognition of deferred tax assets after the
initial accounting period. Consequently, any deferred tax assets recognized by the acquiree after the end of that period in
respect of temporary differences or tax loss carry-forwards existing at the acquisition date are recognized in profit or loss.
The positions adopted by Sanofi in tax matters are based on its interpretation of tax laws and regulations. Some of those positions
may be subject to uncertainty. In such cases, Sanofi assesses the amount of the tax liability on the basis of the following
assumptions: that its position will be examined by one or more tax authorities on the basis of all relevant information; that a technical
assessment is carried out with reference to legislation, case law, regulations, and established practice; and that each position is
assessed individually (or collectively where appropriate), with no offset or aggregation between positions. Those assumptions are
assessed on the basis of facts and circumstances existing at the end of the reporting period. When an uncertain tax liability is
regarded as probable, it is measured on the basis of Sanofi’s best estimate and recognized as a liability; uncertain tax assets are not
recognized. The amount of the liability includes any penalties and late payment interest. The line item Income tax expense includes
the effects of tax reassessments and tax disputes, and any penalties and late payment interest arising from such disputes that have
the characteristics of income taxes within the meaning of paragraph 2 of IAS 12 (“taxes which are based on taxable profits”). Tax
exposures relating to corporate income taxes are presented separately within Non-current income tax liabilities (see Note D.19.4.).
SANOFI FORM 20-F 2025 | F-27 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
taxed income (GILTI) provisions. The related tax expense is recognized in the year in which it is declared in the tax return to the
extent that it arises from the existence of non-US profits that exceed the theoretical return on investment specified in the
GILTI provisions and are taxed at a rate lower than the applicable US tax rate.
As a reminder, Sanofi has applied in its consolidated financial statements “International Tax Reform – Pillar Two Model Rules”, an
amendment to IAS 12 issued by the IASB on May 23, 2023, and has not recognized deferred tax on temporary differences related
to Pillar Two rules.
In accordance with IAS 1 (Presentation of Financial Statements), current income tax assets and liabilities are presented as
separate line items in the consolidated balance sheet.
B.23. Employee benefit obligations
Sanofi offers retirement benefits to employees and retirees. Such benefits are accounted for in accordance with IAS 19 (Employee
Benefits).
Benefits are provided in the form of either defined contribution plans or defined benefit plans. In the case of defined contribution
plans, the cost is recognized immediately in the period in which it is incurred, and equates to the amount of the contributions paid
by Sanofi. For defined benefit plans, Sanofi recognizes its obligations to pay pensions and similar benefits to employees as a liability,
based on an actuarial estimate of the rights vested or currently vesting in employees and retirees, using the projected unit credit
method. Estimates are performed at least once a year, and rely on financial assumptions (such as discount rates, the inflation rate
and the rate of salary increases) and demographic assumptions (such as life expectancy, retirement age and employee turnover).
Obligations relating to other post-employment benefits (healthcare and life insurance) offered by Sanofi companies to
employees are also recognized as a liability based on an actuarial estimate of the rights vested or currently vesting in employees
and retirees at the end of the reporting period.
Such liabilities are recognized net of the fair value of plan assets.
In the case of multi-employer defined benefit plans where plan assets cannot be allocated to each participating employer with
sufficient reliability, the plan is accounted for as a defined contribution plan, in accordance with paragraph 34 of IAS 19.
The benefit cost for the period consists primarily of current service cost, past service cost, net interest cost, gains or losses arising
from plan settlements not specified in the terms of the plan, and the impact of plan curtailments. Net interest cost for the period
is determined by applying the opening discount rate specified in IAS 19 to the net liability (i.e. the amount of the obligation, net of
plan assets) recognized in respect of defined benefit plans. Past service cost is recognized immediately in profit or loss in the
period in which it is incurred, regardless of whether or not the rights have vested at the time of adoption (in the case of a new
plan) or of amendment (in the case of an existing plan).
Actuarial gains and losses on defined benefit plans (pensions and other post-employment benefits), also referred to
as “Remeasurements of the net defined benefit liability (asset)”, arise as a result of changes in financial and demographic
assumptions, experience adjustments, and the difference between the actual return and the return on plan assets included in the
calculation of the net interest cost. The impacts of those remeasurements are recognized in Other comprehensive income, net
of deferred taxes; they are not subsequently reclassifiable to profit or loss.
B.24. Share-based payment
Share-based payment expense is recognized as a component of operating income, in the relevant classification of expense by
function. In measuring the expense, the level of attainment of any performance conditions is taken into account.
B.24.1. Stock option plans
Sanofi has granted a number of equity-settled share-based payment plans (stock option plans) to some of its employees. The
terms of those plans may make the award contingent on the attainment of performance criteria for some of the grantees.
In accordance with IFRS 2 (Share-Based Payment), services received from employees as consideration for stock options are
recognized as an expense in the income statement, with the opposite entry recognized in equity. The expense corresponds to the
fair value of the stock option plans, and is charged to income on a straight-line basis over the four-year vesting period of the plan.
The fair value of stock option plans is measured at the date of grant using the Black-Scholes valuation model, taking into account
the expected life of the options. The resulting expense also takes into account the expected cancellation rate of the options. The
expense is adjusted over the vesting period to reflect (i) actual cancellation rates resulting from option-holders ceasing to be
employed by Sanofi and (ii) attainment of non-market performance conditions.
B.24.2. Employee share ownership plans
Sanofi may offer its employees the opportunity to subscribe to reserved share issues at a discount to the reference market price. Shares
awarded to employees under such plans fall within the scope of IFRS 2. Consequently, an expense is recognized at the subscription
date, based on the value of the discount offered to employees, with the opposite entry recognized in equity.
F-28 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
B.24.3. Restricted share plans
Sanofi may award restricted share plans to certain of its employees. The terms of those plans may make the award contingent on
the attainment of performance criteria for some of the grantees.
In accordance with IFRS 2, an expense equivalent to the fair value of such plans is recognized in profit or loss on a straight line
basis over the vesting period of the plan, with the opposite entry recognized in equity. The vesting period is three years .
The fair value of restricted share plans is based on the quoted market price of Sanofi shares at the date of grant, adjusted for
expected dividends during the vesting period; it also takes account of any vesting conditions contingent on stock market
performance, measured using the Monte-Carlo valuation model. Other vesting conditions are taken into account in the estimate
of the number of shares awarded during the vesting period; that number is then definitively adjusted based on the actual number
of shares awarded on the vesting date.
B.25. Earnings per share
Basic earnings per share is calculated using the weighted average number of shares outstanding during the reporting period,
adjusted on a time-weighted basis from the acquisition date to reflect the number of own shares held by Sanofi. Diluted earnings
per share is calculated on the basis of the weighted average number of ordinary shares, computed using the treasury stock method.
This method assumes that (i) all outstanding dilutive options and warrants are exercised, and (ii) Sanofi acquires its own shares at
the quoted market price for an amount equivalent to the cash received as consideration for the exercise of the options or
warrants, plus the expense arising on unamortized stock options.
In accordance with IFRS 8 (Operating Segments), the segment information reported by Sanofi is prepared on the basis of internal
management data provided to our Chief Executive Officer, who is the chief operating decision maker of Sanofi. The performance
of the segment is monitored individually using internal reports and indicators.
Information about operating segments in accordance with IFRS 8 is presented in Note D.35., “Segment information”.
C.1. Alliance arrangements with Regeneron Pharmaceuticals, Inc. (Regeneron)
Collaboration agreements on human therapeutic antibodies
In November 2007, Sanofi and Regeneron signed two agreements (amended in November 2009) relating to human therapeutic
antibodies: (i) the Discovery and Preclinical Development Agreement, and (ii) the License and Collaboration Agreement, relating
to clinical development and commercialization. Under the License and Collaboration Agreement, Sanofi had an option to develop
and commercialize antibodies discovered by Regeneron under the Discovery and Preclinical Development Agreement.
Discovery and development
Because Sanofi decided not to exercise its option to extend the Discovery and Preclinical Development Agreement, that
agreement expired on December 31, 2017.
As a result of Sanofi’s exercise of an option with respect to an antibody under the Discovery and Preclinical Development
Agreement, such antibody became a “Licensed Product” under the License and Collaboration Agreement, pursuant to which
Sanofi and Regeneron co-develop the antibody with Sanofi initially being wholly responsible for funding the development
program. On receipt of the first positive Phase 3 study results for any antibody being developed under the License and
Collaboration Agreement, the subsequent development costs for that antibody are split 80 % Sanofi, 20 % Regeneron. Amounts
received from Regeneron under the License and Collaboration Agreement are recognized by Sanofi as a reduction in the line
item Research and development expenses. Co-development with Regeneron of the antibodies Dupixent, Kevzara and
REGN3500 (SAR440340 - itepekimab) is ongoing under the License and Collaboration Agreement as of December 31, 2025.
Once a product begins to be commercialized, and provided that the share of quarterly results under the agreement represents a
profit, Sanofi is entitled to an additional portion of Regeneron’s profit-share (capped at 20 % of Regeneron’s share of quarterly
profits since April 1, 2022, and at 10 % until March 31, 2022) until Regeneron has paid 50 % of the cumulative development costs
incurred by the parties in the collaboration (see Note D.21.1.).
On the later of (i) 24 months before the scheduled launch date or (ii) the first positive Phase 3 study results, Sanofi and Regeneron
share the commercial expenses of the antibodies co-developed under the License and Collaboration Agreement.
SANOFI FORM 20-F 2025 | F-29 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
Commercialization
Sanofi is the lead party with respect to the commercialization of all co-developed antibodies, and Regeneron has certain option
rights to co-promote the antibodies. Regeneron has exercised its co-promotion rights in the US and in certain other countries.
Sanofi recognizes all sales of the antibodies. Profits and losses arising from commercial operations in the US are split 50 /50.
Outside the US, Sanofi is entitled to between 55 % and 65 % of profits depending on sales of the antibodies, and bears 55 % of any
losses. The share of profits and losses due to or from Regeneron under the agreement is recognized within the line items Other
operating income or Other operating expenses, which are components of Operating income.
In addition, Regeneron is entitled to receive payments contingent on the attainment of specified levels of aggregate sales on all
antibodies outside the US, on a rolling twelve-month basis. The opposite entry for that liability is capitalized within Other
intangible assets on the balance sheet. Two payments of $50
$2.0 billion and then of $2.5 billion in sales of all antibodies outside the US on a rolling twelve-month basis. The final milestone
payment of $50 million, payable to Regeneron in the event that $3.0 billion in sales on a rolling twelve-month basis is attained,
was made in 2023.
Amendments to the collaboration agreements
In January 2018, Sanofi and Regeneron signed a set of amendments to their collaboration agreements, including an amendment
that allowed for the funding of additional programs on Dupixent and REGN3500 (SAR440340 – itepekimab) with an intended
focus on extending the current range of indications, finding new indications, and improving co-morbidity between multiple
pathologies.
Effective April 1, 2020, Sanofi and Regeneron signed a Cross License and Commercialization Agreement for Praluent, whereby
Sanofi obtained sole ex-US rights to Praluent, and Regeneron obtained sole US rights to Praluent along with a right to 5 %
royalties on Sanofi’s sales of Praluent outside the US. Each party is solely responsible for funding the development, manufacturing
and commercialization of Praluent in their respective territories. Although each party has sole responsibility for supplying Praluent
in its respective territory, Sanofi and Regeneron are parties to agreements to support manufacturing needs for each other. These
agreements were renewed with an effective date of April 2025 to maintain the supply of active ingredients from Regeneron to
Sanofi until March 2026, and the supply of finished goods from Sanofi to Regeneron until December 2028.
Effective September 30, 2021, Sanofi and Regeneron signed an amendment to their collaboration agreement in order to specify
allocations of responsibilities and associated resources between the two parties in connection with the co-promotion of Dupixent
in certain countries. The terms of the collaboration relating to REGN3500 (SAR440340 – itepekimab) are unchanged.
Effective July 1, 2022, Sanofi and Regeneron signed an amendment to their collaboration agreement in order to increase the
additional portion of Regeneron’s quarterly profit-share attributable to Sanofi from 10 % to 20 % with retroactive impact as of
April 1, 2022.
Immuno-oncology (IO) collaboration agreements
On July 1, 2015, Sanofi and Regeneron signed two agreements – the IO Discovery and Development Agreement and the IO
License and Collaboration Agreement (IO LCA) – relating to new antibody cancer treatments in the field of immuno-oncology.
The Amended IO Discovery Agreement, effective from December 31, 2018, was terminated through a Letter Amendment dated
March 16, 2021 in which Sanofi formalized its opt-out from the BCMAxCD3 and MUC16xCD3 programs.
LIBTAYO (cemiplimab)
Under the 2015 IO LCA as amended in January 2018, Sanofi and Regeneron committed funding of no more than $1,640 million,
split on a 50 /50 basis ($820 million per company), for the development of REGN2810 (cemiplimab, trademark Libtayo), a PD-1
inhibitor antibody. The funding was raised to $1,840 million by way of amendment effective on September 30, 2021. Regeneron
was responsible for the commercialization of Libtayo in the US, and Sanofi in all other territories. Sanofi has exercised its option to
co-promote Libtayo in the United States. In 2021, Regeneron exercised its option to co-promote Libtayo in certain other
countries.
In June 2022, Sanofi and Regeneron restructured their IO LCA. Under the terms of the Amended and Restated IO LCA,
Regeneron holds exclusive worldwide licensing rights to Libtayo with effect from July 1, 2022.
In July 2022, Sanofi received as consideration an upfront payment of $900 million (€856 million), which was recognized within
Other operating income on the date of receipt. The same line item also includes a regulatory milestone payment of $100 million
(€96 million) following the FDA approval in November 2022 of Libtayo in combination with chemotherapy as a first line treatment
for NSCLC (non-small cell lung cancer). In addition, Sanofi is entitled to royalties of 11 % and to milestone payments (€116 million in
2023, €111 million in 2022) linked to global net sales of Libtayo; those royalties are recognized within Other operating income in
line with the pattern of sales. All of the cash inflows relating to the above items (€138 million in 2025, €117 million in 2024,
€196 million in 2023) are presented within Net cash provided by/(used in) operating activities in the consolidated statement of
cash flows.
The amendment to the terms of the IO LCA resulted in Sanofi recognizing an accelerated amortization charge of €226 million
in 2022; this was allocated to the Libtayo product rights included within the residual carrying amount of the intangible asset
recognized in July 2015 to reflect rights to an antibody targeting the immune checkpoint receptor PD-1 (programmed cell death
protein-1) under the Sanofi/Regeneron alliance.
F-30 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
The transaction also included time-limited transitional services agreements with Regeneron, including manufacturing,
distribution (for which Sanofi acted as agent), and promotion. Those services were all ended in 2025.
C.2. Agreements on the commercialization of Beyfortus
(nirsevimab, previously MEDI8897) in the US
On March 1, 2017, Sanofi and AstraZeneca entered into an agreement to develop and commercialize a monoclonal antibody
(MEDI8897, nirsevimab) for the prevention of Respiratory Syncytial Virus (RSV) associated illness in newborns and infants.
Under the terms of the agreement, Sanofi made an upfront payment of €120 million in March 2017, a development milestone
payment of €30 million in the third quarter of 2019, a regulatory milestone payment of €25 million associated with the approval of
Beyfortus (nirsevimab) by the EMA in Europe in November 2022, and a regulatory milestone payment of €65 million associated
with the approval of Beyfortus (nirsevimab) by the US FDA in July 2023.
In addition, Sanofi could pay AstraZeneca up to €375 million if sales objectives are met. Those amounts are recognized as a
component of the value of the intangible asset when payment becomes probable.
In 2024, two payments of €25 million and of €50 million were made to AstraZeneca further to contractual sales thresholds being
met. In 2025, an additional payment of €100 million was made in relation to a contractual sales threshold achieved in the last
quarter of 2024. No other sales milestone was achieved in 2025.
The agreement also specifies that AstraZeneca is responsible for development and manufacturing, and Sanofi for
commercialization. Sanofi recognizes the sales and cost of sales (purchases of finished products from AstraZeneca) and shares
the Alliance’s commercial profits (i) 50 /50 in major territories and (ii) based on 25 % of net revenues in other territories. The share
of commercial profits and losses due to or from AstraZeneca is recognized as a component of operating income, within the line
items Other operating income or Other operating expenses. In addition, Sanofi and AstraZeneca share development costs,
with Sanofi’s portion recognized within the income statement line item Research and development expenses.
On April 9, 2023, Sanofi and AstraZeneca simplified their contractual agreements for the development and commercialization of
Beyfortus (nirsevimab) in the US. Sanofi thereby obtained control of all commercial rights to Beyfortus (nirsevimab) in the US, and
ended the sharing of commercial profits between the two partners in that territory. In line with the terms of the revised
agreements and in accordance with IAS 38, Sanofi recognized an intangible asset of €1.6 billion for the fair value of the additional
US rights. On the same date, AstraZeneca and Sobi ended their participation agreement, signed in 2018, which transferred the
economic rights for the US territory to Sobi.
Sanofi simultaneously entered into an agreement with Sobi relating to direct royalties on US net sales of Beyfortus (nirsevimab). In
line with the terms of that agreement, on April 9, 2023 Sanofi recognized a financial liability amounting to €1.6 billion. That liability
is classified as a financial liability at amortized cost under IFRS 9. Other than royalty payments, subsequent movements in the
liability comprise (i) the unwinding of discount and (ii) changes in estimates of future cash outflows for royalty payments. Those
movements will be recognized in the income statement within Net financial income/(expenses) in accordance with paragraph
B.5.4.6 of IFRS 9.
As of December 31, 2025 the liability was remeasured by an amount of €(93 ) million (€291 million as of December 31, 2024 and
€541 million as of December 31, 2023; the remeasurement in 2023 reflected the strong success of the US launch of Beyfortus,
which led to sales forecasts being revised upward from the initial estimate). The resulting adjustment was recognized within
Financial expenses.
For territories other than the US (except for China, which is now considered a “major market,” with profits/losses shared 50/50
with AstraZeneca), the existing agreement between AstraZeneca and Sanofi continues to govern the principal terms of the
collaboration: Sanofi recognizes the sales and cost of sales and shares the Alliance’s commercial profits with AstraZeneca.
Beyfortus was approved in Europe in November 2022, in the US in July 2023, in China and Japan during the first quarter of 2024,
and in a number of other countries in 2025.
SANOFI FORM 20-F 2025 | F-31 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
D/ Presentation of the financial statements
D.1.1. Significant transactions of 2025
D.1.1.1.Opella - Loss of control and equity interest in the associate OPAL JV Co
On April 30, 2025, Sanofi and CD&R closed the Opella transaction following the signature of the share purchase agreement (SPA)
on February 18, 2025. Sanofi retains a significant shareholding in Opella, through a 48.2 % equity interest in the associate OPAL JV
Co (based in Luxembourg), which indirectly holds 100 % of Opella. Bpifrance owns a 1.8 % equity interest, and is represented on
Opella’s Board of Directors.
Completion of the deal resulted in the loss of control of Opella by Sanofi and the derecognition of Opella’s assets and liabilities.
This resulted in a net gain of €2.6 billion, reported within the line item Net income from discontinued operations in the
consolidated income statement. The proceeds from the divestment of Opella, determined on the basis of a €16 billion enterprise
value, reflect the price of the Opella shares. That price may be subject to adjustment following the finalization of the Opella
completion accounts as of April 30, 2025, which is expected to occur in the first quarter of 2026 in accordance with the SPA.
As of the closing date of the transaction, the carrying amount of Opella’s assets and liabilities in the Sanofi consolidated balance
sheet was €11.3 billion.
The gain took into account the following components: (i) a reclassification of unrealized foreign exchange losses amounting to
€0.5 billion associated with Opella operations, in accordance with IAS 21 (“The Effects of Changes in Foreign Exchange Rates”);
(ii) recognition of the retained 48.2% equity interest in the associate OPAL JV Co (over which Sanofi exercises significant
influence as defined in IAS 28 “Investments in Associates and Joint Ventures”), reported within the balance sheet line item
Investments accounted for using the equity method at an amount of €3.2 billion (representing the fair value of the equity
interest at the date of initial recognition in accordance with IFRS 10 and included in the estimated share price, plus capitalized
transaction costs); and (iii) other items, mainly comprising compensation as agreed under the separation agreements.
The Opella transaction generated a net cash inflow of €10.4 billion, presented within the line item Net cash inflow from the
Opella transaction in the statement of cash flows.
The Shareholders’ Agreement between Sanofi and CD&R provides for a lock-up period of three years from the closing date,
during which Sanofi is only permitted to carry out certain types of direct or indirect transfers of its securities in OPAL JV Co;
thereafter any transfer by Sanofi is subject to a right of first offer in favor of CD&R, together with customary tag‑along and
drag‑along rights.
As a reminder, on October 21, 2024, Sanofi and CD&R entered into exclusive negotiations for the transfer of a controlling interest
in Opella. As of December 31, 2024, completion of the transaction was considered highly probable. In accordance with the
classification and presentation requirements of IFRS 5 (see Note B.7.), all assets of Opella and all liabilities directly related to those
assets were classified from October 21, 2024 in the line items Assets held for sale and Liabilities related to assets held for sale,
respectively, in the consolidated balance sheet (see Notes D.8. and D.36.) Opella (formerly known as Consumer Healthcare)
constituted an operating segment of Sanofi until October 21, 2024 (see Note D.35., "Segment Information"). Consequently,
Opella met the definition of a discontinued operation under IFRS 5 (see Note B.7.), as a result of which the net income from that
business was presented separately within the line item Net income from discontinued operations in the consolidated income
statement. This presentation in a separate income statement line item applied to operations for the year ended December 31,
2024 and December 31, 2025, and on a consistent basis for the comparative period presented (2023). The cash flows arising from
operating, investing and financing activities of the Opella business were also presented in separate line items in the consolidated
statements of cash flows for the year ended December 31, 2024 and December 31, 2025 and for the comparative period
presented (2023).
As regards the product liability claims described in Note D.22. "Legal and arbitral proceedings", and in particular the ongoing
litigation relating to Zantac in the US, the Separation Agreement, executed July 2024, specifies that Sanofi is to indemnify Opella,
without limitation as to amount, for all liabilities resulting from the marketing of any Zantac brand product containing ranitidine as
an active pharmaceutical ingredient, including product liability claims.
D.1.1.2. Acquisition of Dren-0201, Inc.
On May 27, 2025, Sanofi announced the completion of the acquisition of 100% of Dren-0201, Inc., adding SAR448501 (formerly
DR-0201) to Sanofi’s immunology pipeline. DR-0201, now named SAR448501, has shown robust B-cell depletion in pre-clinical
and early clinical studies. This potential first-in-class targeted bispecific myeloid cell engager targets and engages specific
tissue-resident and trafficking myeloid cells to induce deep B-cell depletion via targeted phagocytosis. Recent pre-clinical and
early clinical study data in autoimmune diseases suggest that deep B-cell depletion has the potential to reset the adaptive
immune system, leading to sustained treatment-free remission in patients with refractory B-cell mediated autoimmune diseases
such as lupus, where significant unmet medical needs remain.
The transaction did not meet the criteria for a business combination under IFRS 3, and consequently was accounted for as an
acquisition of a group of assets.
F-32 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
The acquisition price was €536 million. Of that amount (plus acquisition-related costs), €522 million was allocated to in-process
development in respect of SAR448501, and recognized within Other intangible assets in accordance with IAS 38. The difference
between that amount and the acquisition price corresponds to the other assets acquired and liabilities assumed in the
transaction.
In addition, potential future payments totalling €1.2 billion contingent on attainment of certain development and launch
milestones have been recognized as off balance sheet commitments. These milestones will be added to the value of the
SAR448501 intangible asset if and when achieved.
The impact of this acquisition, as reflected within the line item Acquisitions of consolidated undertakings and investments
accounted for using the equity method in the consolidated statement of cash flows, is a net cash outflow of €539 million.
D.1.1.3. Acquisition of Vigil Neuroscience, Inc.
On May 22, 2025, Sanofi announced that it had entered into an agreement to acquire Vigil Neuroscience, Inc. (Vigil), a publicly
traded clinical-stage biotechnology company focused on developing novel therapies for neurodegenerative diseases. This
acquisition in neurology, one of Sanofi’s four strategic disease areas, enhances Sanofi’s early-stage pipeline and includes
VG-3927, which will be evaluated in a Phase 2 clinical study in Alzheimer’s disease. VG-3927 is an oral small molecule TREM2
agonist. Activating TREM2 is expected to enhance the neuroprotective function of microglia in Alzheimer’s disease.
Under the terms of a share purchase agreement (including the exclusive right of first negotiation for an exclusive license to
VG-3927 or for transfer of the rights to research, develop, manufacture, and commercialize VG-3927) entered into by Sanofi and
Vigil in June 2024 for an amount of $40 million, Sanofi already held an equity interest in Vigil, representing approximately 12 % of
Vigil’s share capital. That equity interest was remeasured through Other comprehensive income.
VGL101, Vigil’s second molecule program, was not acquired by Sanofi.
On August 5, 2025, Sanofi acquired all outstanding common shares of Vigil for $8.00 per share in cash at closing. Based on $8.00
per share, the total equity value of Vigil represents approximately $470 million (on a fully diluted basis).
In addition, Vigil’s shareholders received one non-transferable and non-tradable contractual contingent value right (CVR) per
Vigil share, entitling the holder to receive a deferred cash payment of $2.00 contingent upon the first commercial sales of
VG-3927. That contingent consideration was recognized in Liabilities related to business combinations and to
non-controlling interests as of December 31, 2025 (see Note D.18.); the nominal value of the contingent consideration is
$114 million.
The provisional purchase price allocation resulted in the recognition of goodwill amounting to €208 million, as indicated below:
(€ million) | Value at acquisition date |
Other intangible assets | |
Other current and non-current assets and liabilities | ( |
Cash and cash equivalents | |
Net deferred tax position | |
Net assets of Vigil | |
Goodwill | |
Equity interests in Vigil acquired in June 2024 | ( |
Purchase price (a) |
Other intangible assets represent the value of the VG-3927 IPR&D project.
Goodwill mainly represents the future profits expected from additional pipeline products targeting various neurodegenerative
diseases, strengthening Sanofi’s strategic presence in the neurology therapeutic area.
The goodwill arising on this acquisition is not tax deductible.
Vigil has no commercial operations.
Acquisition-related costs were immaterial.
The impact of this acquisition, as reflected within the line item Acquisitions of consolidated undertakings and investments
accounted for using the equity method in the consolidated statement of cash flows, is a net cash outflow of €326 million.
D.1.1.4. Acquisition of Blueprint Medicines Corporation
On June 2, 2025, Sanofi and Blueprint Medicines Corporation (Blueprint), a US-based, publicly traded biopharmaceutical
company specializing in the rare immunological disease systemic mastocytosis (SM) and other KIT-driven diseases, entered into
an agreement under which Sanofi agreed to acquire Blueprint.
The acquisition included a rare immunology disease medicine, Ayvakit/Ayvakyt (avapritinib), approved in the US and the EU, and
a promising advanced and early-stage immunology pipeline. Blueprint’s established presence among allergists, dermatologists,
and immunologists is expected to enhance Sanofi’s growing immunology pipeline.
SANOFI FORM 20-F 2025 | F-33 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
Under the terms of the acquisition, Sanofi agreed to pay $129.00 per share in cash at closing, representing an equity value of
approximately $9.1 billion on a fully diluted basis. Blueprint shareholders also received one non-transferable contractual
contingent value right (CVR) per share, entitling the holder to receive two potential milestone payments of $2.00 and $4.00 per
share on the attainment of future development and regulatory milestones within the applicable milestone period, respectively, for
BLU-808. That contingent consideration was recognized in Liabilities related to business combinations and to
non-controlling interests as of December 31, 2025 (see Note D.18.); the nominal value of the contingent consideration is
$448 million.
The total of the transaction, including potential CVR payments, represents approximately $9.5 billion on a fully diluted basis
(€8.2 billion).
In July 2025, Sanofi obtained control of Blueprint after all tender offer and merger conditions had been met.
The provisional purchase price allocation resulted in the recognition of goodwill amounting to €801 million, as indicated below:
(€ million) | Value at acquisition date |
Other intangible assets | |
Inventories | |
Other non-current and current assets and liabilities | |
Cash and cash equivalents | |
Short-term debt | ( |
Net deferred tax position | ( |
Net assets of Blueprint | |
Goodwill | |
Purchase price (a) |
The other intangible assets recognized mainly comprise (i) the marketed rare immunology disease medicine Ayvakit/Ayvakyt
(avapritinib) and (ii) elenestinib, a next-generation medicine for systemic mastocytosis currently in the development phase and
expected to be a successor to avapritinib .
A fair value remeasurement of €1,129 million was recognized at the acquisition date on finished goods and work-in-process
inventories, to reflect the level of expected profit margin and the amount of inventory on hand; it is expected to be consumed
over a period of approximately 28 months
Goodwill mainly represents the capacity to draw on a specialized structure to refresh the existing product portfolio; the
competencies of Blueprint staff; the benefits derived from the creation of new growth platforms in rare medicine; and other
benefits from the combination of Blueprint and Sanofi.
The goodwill arising on this acquisition is not tax deductible.
Blueprint's contributions to the net sales and business operating income of the Biopharma segment (for a definition refer to Note
D.35. “Segment Information”) since the acquisition date amount to €305 million and €25 million, respectively. Over the same
period, Blueprint made a negative contribution of €621 million to consolidated net income, including amortization of intangible
assets of €255 million; amortization and expenses arising from the impact of acquired inventories of €126 million; and
restructuring costs and similar items of €309 million.
During the year ended December 31, 2025, Blueprint generated net sales of €641 million on a twelve-month basis.
Acquisition-related costs recognized in profit or loss for the period amounted to €25 million.
The impact of this acquisition, as reflected within the line item Acquisitions of consolidated undertakings and investments
accounted for using the equity method in the consolidated statement of cash flows, is a net cash outflow of €7,542 million.
D.1.1.5. Acquisition of Vicebio Ltd.
On December 4, 2025, Sanofi announced the completion of the acquisition of 100% of Vicebio Ltd (Vicebio), a privately held
biotechnology company headquartered in London, UK. The acquisition brings Sanofi an early-stage combination vaccine
candidate for respiratory syncytial virus (RSV) and human metapneumovirus (hMPV), both respiratory viruses, and expands
Sanofi's capabilities in vaccine design and development with Vicebio’s "Molecular Clamp" technology.
Sanofi applied the optional test to identify concentration of fair value under paragraph B7A of IFRS 3. The transaction was
accounted for as an acquisition of a group of assets, given that the principal asset (the VXB-241 project, a bivalent vaccine
candidate targeting RSV and hMPV, currently in development) concentrates substantially all of the fair value of the acquired set
of activities and assets.
The acquisition price was €1,002 million. Of that amount (plus acquisition-related costs), €977 million was allocated to VXB-241
and recognized within Other intangible assets in accordance with IAS 38. The difference between that amount and the
acquisition price corresponds to the other assets acquired and liabilities assumed in the transaction.
F-34 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
In addition, potential future payments of up to $450 million contingent upon the attainment of development and regulatory
milestones have been recognized as off balance sheet commitments. These milestones will be added to the value of the
aforementioned intangible asset if and when attained.
The impact of this acquisition, as reflected within the line item Acquisitions of consolidated undertakings and investments
accounted for using the equity method in the consolidated statement of cash flows, is a net cash outflow of €968 million.
D.1.1.6 Agreed transaction expected to be finalized in the first half of 2026
Acquisition of Dynavax Technologies Corporation
On December 24, 2025, Sanofi announced that it had entered into an agreement to acquire Dynavax Technologies Corporation.
(Dynavax), a publicly traded vaccines company with a marketed adult hepatitis B vaccine (HEPLISAV-B) and a differentiated
shingles vaccine candidate. The acquisition augments Sanofi’s presence in adult immunization by bringing together Dynavax’s
vaccines with Sanofi’s global scale, development capabilities and commercial reach.
Dynavax’s adult hepatitis B vaccine HEPLISAV-B is currently marketed in the US and is differentiated by its two-dose regimen
over one month, which enables high levels of seroprotection faster than other hepatitis B vaccines, which are given in three doses
over six months.
The acquisition also includes Dynavax’s shingles vaccine candidate (Z-1018), which is currently in Phase 1/2 clinical development
and additional vaccine pipeline projects.
Under the terms of the merger agreement, Sanofi will commence a cash tender offer to acquire all outstanding shares of Dynavax
for $15.50 per share in cash, reflecting a total equity value of approximately $2.2 billion.
The transaction has been unanimously approved by the Dynavax Board of Directors.
The acquisition is expected to close in the first quarter of 2026, subject to closing conditions.
A purchase price allocation will be performed at the acquisition date. Sanofi expects the main impacts to be the recognition of
intangible assets, in particular the HEPLISAV-B(R) vaccine commercialized product and Dynavax's shingles vaccine candidate
Z-1018.
D.1.2. Significant transactions of 2024
Acquisition of Inhibrx, Inc
On May 30, 2024, Sanofi completed the acquisition of Inhibrx, Inc (Inhibrx), adding SAR447537 (formerly INBRX-101) to Sanofi’s
rare disease pipeline. SAR447537 is a human recombinant protein that holds the promise of allowing alpha-1 antitrypsin
deficiency (AATD) patients to achieve normalization of serum AAT levels with less frequent (monthly vs. weekly) dosing. AATD is
an inherited rare disease characterized by low levels of AAT protein, predominantly affecting the lungs with progressive tissue
deterioration. SAR447537 may help to reduce inflammation and prevent further deterioration of lung function in affected
individuals.
The transaction did not meet the criteria for a business combination under IFRS 3, and consequently was accounted for as an
acquisition of a group of assets.
The acquisition price was $2,035 million. Of that amount (plus acquisition-related costs), $1,885 million was allocated to
in-process development in respect of SAR447537 and recognized within Other intangible assets in accordance with IAS 38. The
difference between that amount and the acquisition price corresponds to the other assets acquired and liabilities assumed in the
transaction.
In addition, Sanofi awarded the former shareholders of Inhibrx an unquoted, non-negotiable Contingent Value Right (CVR)
certificate entitling them to a deferred cash payment of $5.00 per Inhibrx share, subject to attainment of a specified regulatory
milestone before June 30, 2027. The nominal value of that off balance sheet commitment is $300 million.
The impact of this acquisition, as reflected within the line item Acquisitions of consolidated undertakings and investments
accounted for using the equity method in the consolidated statement of cash flows, is a net cash outflow of $2,035 million.
Enjaymo divestment
On November 29, 2024, Sanofi entered into a definitive agreement with Recordati for the sale of Sanofi's global rights to Enjaymo
and the transfer of specific employees. Under this agreement, Sanofi received an upfront payment of $825 million and will be
eligible for milestone payments of up to $250 million based on sales.
This agreement led to the derecognition of assets relating to the Enjaymo activity, including goodwill of €276 million. The gain
arising on the divestment was immaterial.
The impact of the divestment in the consolidated cash flow statement, as reflected in the line item Proceeds from disposals of
property, plant and equipment, intangible assets and other non-current assets, net of tax, is a pre-tax cash inflow of
€768 million.
SANOFI FORM 20-F 2025 | F-35 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
D.1.3. Significant transactions of 2023
Acquisition of Provention Bio, Inc.
On March 13, 2023, Sanofi entered into a merger agreement with Provention Bio, Inc. (Provention), a US-based publicly traded
biopharmaceutical company developing therapies to prevent and intercept immune-mediated diseases including type 1 diabetes.
Under the terms of the agreement, Sanofi acquired the outstanding shares of Provention common stock for $25.00 per share in
an all-cash transaction valued at approximately $2.8 billion.
The acquisition of Provention was completed on April 27, 2023, with Sanofi holding all of the shares of Provention on expiration of
the tender offer.
Sanofi applied the optional test to identify concentration of fair value under paragraph B7A of IFRS 3. The transaction was
accounted for as an acquisition of a group of assets, given that the principal asset (teplizumab-mzwv, commercialized in the US
under the name Tzield) concentrates substantially all of the fair value of the acquired set of activities and assets.
Under the terms of a share purchase agreement entered into by Sanofi and Provention in February 2023, Sanofi already held an
equity interest in Provention, representing approximately 3 % of Provention’s share capital. On the date Sanofi obtained control of
Provention, that equity interest was remeasured at a price of $25.00 per share, representing a total amount of $68 million. The
impact of the remeasurement was recognized in Other comprehensive income.
The acquisition price for the shares not already held was $2,806 million. Out of the total price (including the fair value of the
shares already held), $2,810 million was allocated to Tzield and recognized within Other intangible assets. The difference
between that amount and the acquisition price corresponds to the other assets acquired and liabilities assumed as part of the
transaction, after taking account of the previously-held shares and acquisition-related costs.
The impact of this acquisition as reflected within the line item Acquisitions of consolidated undertakings and investments
accounted for using the equity method in the consolidated statement of cash flows is a net cash outflow of $2,722 million.
Acquisition of QRIB Intermediate Holdings, LLC
On July 28, 2023, Sanofi announced that it had acquired QRIB Intermediate Holdings, LLC (QRIB), the owner of Qunol, a
market-leading US-based health & wellness brand. The acquisition strengthened Opella's operations in the Vitamin, Mineral and
Supplements (VMS) category.
The acquisition of QRIB by Sanofi was completed on September 29, 2023, at a purchase price of $1,419 million.
The final purchase price allocation led to the recognition of goodwill of €484 million, determined as follows:
(€ million) | Fair value at acquisition date |
Other intangible assets | |
Other current and non-current assets and liabilities | |
Cash and cash equivalents | |
Deferred taxes, net | ( |
Net assets of QRIB Intermediate Holdings, LLC | |
Goodwill | |
Purchase price |
The other acquired intangible assets identified consist of the Qunol brand.
Goodwill mainly represents the expected future profits attributable to the development of the VMS platform in the US as a result
of the integration of QRIB into the Sanofi group.
The entire amount of goodwill is deductible for tax purposes over a period of 15 years.
The impact of this acquisition is reflected in Net cash provided by/(used in) investing activities of the discontinued Opella
business in the consolidated statement of cash flows, and represents a net cash outflow of $1,410 million.
Net assets related to this acquisition, including associated goodwill, are part of Opella's net assets and were therefore reclassified
to Assets held for sale and Liabilities related to assets held for sale as of December 31, 2024 (see Note D.36.).
F-36 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
D.2.1. Capital management information
In order to maintain or adjust the capital structure, Sanofi can adjust the amount of dividends paid to shareholders, repurchase its
own shares, issue new shares, or issue securities giving access to its capital.
The following objectives are defined under the terms of Sanofi’s share repurchase programs:
•the implementation of any stock option plan giving entitlement to purchase shares in the Sanofi parent company (see Note D.15.);
•the allotment or sale of shares to employees under statutory profit sharing schemes and employee savings plans;
•the consideration-free allotment of shares (i.e. restricted share plans) (see Note D.15.);
•the cancellation of some or all of the repurchased shares (see Note D.15.);
•market-making in the secondary market by an investment services provider under a liquidity contract in compliance with the
ethical code recognized by the Autorité des marchés financiers (AMF);
•the delivery of shares on the exercise of rights attached to securities giving access to the capital by redemption, conversion,
exchange, presentation of a warrant or any other means;
•the delivery of shares (in exchange, as payment, or otherwise) in connection with mergers and acquisitions;
•the execution by an investment services provider of purchases, sales or transfers by any means, in particular via off-market
trading; or
•any other purpose that is or may in the future be authorized under the applicable laws and regulations.
Sanofi is not subject to any constraints on equity capital imposed by third parties.
Sanofi defines “Net debt” as (i) the sum of short-term debt, long-term debt and interest rate derivatives and currency derivatives
used to hedge debt, minus (ii) the sum of cash and cash equivalents and interest rate derivatives and currency derivatives used to
hedge cash and cash equivalents (see Note D.17.).
D.2.2. Financial risk management
Credit risk
Credit risk is the risk that customers (wholesalers, distributors, pharmacies, hospitals, clinics or government agencies) may fail to
pay their debts; for Sanofi, that risk is mainly concentrated on amounts receivable from wholesalers in the US. Sanofi manages
credit risk by vetting customers in order to set credit limits and risk levels, and asking for guarantees or insurance where
necessary; performing controls; and monitoring qualitative and quantitative indicators of accounts receivable balances, such as
the period of credit taken and overdue payments.
Sales generated by Sanofi with its biggest customers are disclosed in Note D.35.
Market risks
Please refer to "Item 11. Quantitative and Qualitative Disclosures about Market Risk" of this Annual Report on Form 20-F, and to
Notes D.17 and D.20. below.
SANOFI FORM 20-F 2025 | F-37 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
D.3. Property, plant and equipment
D.3.1. Property, plant and equipment owned
(€ million) | Land | Buildings | Machinery and equipment | Fixtures, fittings and other | Property, plant and equipment in process | Total |
Gross value at January 1, 2023 | ||||||
Changes in scope of consolidation | ( | ( | ( | ( | ( | |
Acquisitions and other increases | ||||||
Disposals and other decreases | ( | ( | ( | ( | ( | ( |
Currency translation differences | ( | ( | ( | ( | ( | ( |
Transfers(a) | ( | ( | ( | |||
Gross value at December 31, 2023 | ||||||
Changes in scope of consolidation | ||||||
Acquisitions and other increases | ||||||
Disposals and other decreases | ( | ( | ( | ( | ( | ( |
Currency translation differences | ||||||
Transfers(a) | ( | ( | ||||
Opella reclassification (b) | ( | ( | ( | ( | ( | ( |
Gross value at December 31, 2024 | ||||||
Changes in scope of consolidation | ||||||
Acquisitions and other increases | ||||||
Disposals and other decreases | ( | ( | ( | ( | ( | ( |
Currency translation differences | ( | ( | ( | ( | ( | ( |
Transfers(a) | ( | ( | ( | |||
Gross value at December 31, 2025 | ||||||
Accumulated depreciation & impairment at January 1, 2023 | ( | ( | ( | ( | ( | ( |
Changes in scope of consolidation | ||||||
Depreciation expense | ( | ( | ( | ( | ||
Impairment losses, net of reversals | ( | ( | ( | ( | ( | |
Disposals and other decreases | ||||||
Currency translation differences | ||||||
Transfers(a) | ( | ( | ||||
Accumulated depreciation & impairment at December 31, 2023 | ( | ( | ( | ( | ( | ( |
Changes in scope of consolidation | ||||||
Depreciation expense | ( | ( | ( | ( | ||
Impairment losses, net of reversals | ( | ( | ( | ( | ( | |
Disposals and other decreases | ||||||
Currency translation differences | ( | ( | ( | ( | ||
Transfers(a) | ( | |||||
Opella reclassification (b) | ||||||
Accumulated depreciation & impairment at December 31, 2024 | ( | ( | ( | ( | ( | |
Depreciation expense | ( | ( | ( | ( | ||
Impairment losses, net of reversals | ( | ( | ( | |||
Disposals and other decreases | ||||||
Currency translation differences | ||||||
Transfers(a) | ( | |||||
Accumulated depreciation & impairment at December 31, 2025 | ( | ( | ( | ( | ( | |
Carrying amount at December 31, 2023 | ||||||
Carrying amount at December 31, 2024 | ||||||
Carrying amount at December 31, 2025 |
Opella assets) to Assets held for sale.
F-38 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
(€ million) | 2025 | 2024 | 2023 |
Acquisitions | |||
Biopharma (operating segment) | |||
of which Manufacturing & Supply | |||
Opella (discontinued operation, see Note D.1.) | |||
Of which capitalized interest |
below:
(€ million) | 2025 | 2024 | 2023 |
Firm orders of property, plant and equipment | |||
Property, plant and equipment pledged as security for liabilities |
(€ million) | 2025 | 2024 | 2023 |
Net impairment losses on property, plant and equipment(a) |
shutdowns or changes in use of industrial sites.
SANOFI FORM 20-F 2025 | F-39 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
D.3.2. Property, plant and equipment leased – right-of-use assets
(€ million) | Right-of-use assets |
Gross value at January 1, 2023 | |
Acquisitions and other increases | |
Disposals and other decreases | ( |
Currency translation differences | ( |
Transfers(a) | ( |
Gross value at December 31, 2023 | |
Acquisitions and other increases | |
Disposals and other decreases | ( |
Currency translation differences | |
Transfers(a) | ( |
Opella reclassification (b) | ( |
Gross value at December 31, 2024 | |
Changes in scope of consolidation | |
Acquisitions and other increases | |
Disposals and other decreases | ( |
Currency translation differences | ( |
Transfers (a) | ( |
Gross value at December 31, 2025 | |
Accumulated depreciation & impairment at January 1, 2023 | ( |
Changes in scope of consolidation | |
Depreciation and impairment charged in the period | ( |
Disposals and other decreases | |
Currency translation differences | |
Transfers(a) | |
Accumulated depreciation & impairment at December 31, 2023 | ( |
Depreciation and impairment charged in the period | ( |
Disposals and other decreases | |
Currency translation differences | ( |
Transfers(a) | |
Opella reclassification (b) | |
Accumulated depreciation & impairment at December 31, 2024 | ( |
Depreciation and impairment charged in the period | ( |
Disposals and other decreases | |
Currency translation differences | |
Accumulated depreciation & impairment at December 31, 2025 | ( |
Carrying amount at December 31, 2023 | |
Carrying amount at December 31, 2024 | |
Carrying amount at December 31, 2025 |
Leased assets comprised offices and industrial premises (89 %) and the vehicle fleet (11 %) as of December 31, 2025.
Annual lease costs on short term leases and low value asset leases amounted to €16 million in the year ended December 31, 2025,
€16 million in the year ended December 31, 2024, and €19 million in the year ended December 31, 2023. Variable lease payments,
sub-leasing activities, and sale-and-leaseback transactions were immaterial.
Total cash outflows on leases (excluding annual lease costs on short term leases and low value asset leases) were €393 million
in the year ended December 31, 2025, €348 million in the year ended December 31, 2024, and €315 million in the year
ended December 31, 2023.
A maturity analysis of the lease liability is disclosed in Note D.17.2.
Commitments related to short-term leases and low value asset leases, including future payments for lease contracts committed
but not yet commenced, are disclosed in Note D.21.
F-40 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
D.4. Goodwill and other intangible assets
(€ million) | Goodwill |
Balance at January 1, 2023 | |
Acquisitions during the period | |
Other movements during the period(a) | ( |
Currency translation differences | ( |
Balance at December 31, 2023 | |
Acquisitions during the period | |
Other movements during the period(a) | ( |
Currency translation differences | |
Opella reclassification(b) | ( |
Balance at December 31, 2024 | |
Acquisitions during the period(c) | |
Other movements during the period(a) | ( |
Currency translation differences | ( |
Balance at December 31, 2025 |
allocated goodwill relating to the divestment of the Enjaymo activity to Recordati (see Note D.1.).
€208 million, respectively, as of the respective acquisition dates (see Note D.1.).
In accordance with IAS 36, goodwill is allocated to groups of Cash Generating Units (CGUs) at a level corresponding to the
Biopharma operating segment (see Note D.35.).
For the purpose of annual impairment testing of goodwill, the recoverable amount was determined on the basis of value in use, as
derived from discounted estimates of the future cash flows in accordance with the policies described in Note B.6.1.
SANOFI FORM 20-F 2025 | F-41 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
(€ million) | Acquired R&D | Products, trademarks and other rights | Software | Total other intangible assets |
Gross value at January 1, 2023(a) | ||||
Changes in scope of consolidation(c) | ||||
Acquisitions and other increases(e) | ||||
Disposals and other decreases | ( | ( | ( | ( |
Currency translation differences | ( | ( | ( | ( |
Transfers(b) | ( | ( | ( | |
Gross value at December 31, 2023 | ||||
Changes in scope of consolidation(c) | ||||
Acquisitions and other increases(e) | ||||
Disposals and other decreases | ( | ( | ( | ( |
Currency translation differences | ||||
Transfers(b) | ( | ( | ||
Opella reclassification(a) | ( | ( | ( | ( |
Gross value at December 31, 2024 | ||||
Changes in scope of consolidation(c) | ||||
Acquisitions and other increases(e) | ||||
Disposals and other decreases | ( | ( | ( | ( |
Currency translation differences | ( | ( | ( | ( |
Transfers(b) | ( | ( | ( | |
Gross value at December 31, 2025 | ||||
Accumulated amortization & impairment at January 1, 2023(a) | ( | ( | ( | ( |
Changes in scope of consolidation | ||||
Amortization expense | ( | ( | ( | |
Impairment losses, net of reversals(d) | ( | ( | ( | |
Disposals and other decreases | ||||
Currency translation differences | ||||
Transfers(b) | ||||
Accumulated amortization & impairment at December 31, 2023 | ( | ( | ( | ( |
Amortization expense | ( | ( | ( | |
Impairment losses, net of reversals(d) | ( | ( | ||
Disposals and other decreases | ||||
Currency translation differences | ( | ( | ( | ( |
Transfers(b) | ( | ( | ( | |
Opella reclassification(a) | ||||
Accumulated amortization & impairment at December 31, 2024 | ( | ( | ( | ( |
Amortization expense | ( | ( | ( | |
Impairment losses, net of reversals(d) | ( | ( | ( | |
Disposals and other decreases | ||||
Currency translation differences | ||||
Transfers(b) | ||||
Accumulated amortization & impairment at December 31, 2025 | ( | ( | ( | ( |
Carrying amount at December 31, 2023 | ||||
Carrying amount at December 31, 2024 | ||||
Carrying amount at December 31, 2025 |
Opella assets) as Assets held for sale.
F-42 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
In 2023:
–the rights acquired as a result of the simplification agreed between Sanofi and AstraZeneca in April 2023 in respect of the agreements on Beyfortus
(nirsevimab) (see Note C.2.);
–an upfront payment of $500 million relating to the rights acquired under the agreement with Teva Pharmaceuticals on the co-development and
co-commercialization of TEV’574; and
–an upfront payment of $175 million for the rights acquired under the agreement with Janssen Pharmaceuticals, Inc. relating to a vaccine against
extra-intestinal pathogenic strains of E-Coli.
In 2024:
–an upfront payment of $500 million for the rights acquired under the agreement with Novavax relating to the co-exclusive license agreement for the
co-commercialization of a COVID-19 vaccine and the development of a combined flu-COVID-19 vaccine; and
–an upfront payment of $300 million for the rights acquired under an agreement with Corxel Pharmaceuticals for the development and
commercialization rights to aficamten in China.
“Products, trademarks and other rights” mainly comprise:
•“marketed products”, with a carrying amount of €16.2 billion as of December 31, 2025 (versus €12.7 billion as of December 31,
2024 and €16.6 billion as of December 31, 2023) and a weighted average amortization period of approximately 10 years; and
•“technology platforms”, with a carrying amount of €0.9 billion as of December 31, 2025 (versus €1.1 billion as of December 31,
2024 and €1.2 billion as of December 31, 2023) and a weighted average amortization period of approximately 18 years.
acquisitions made by Sanofi and represented 91 % of the carrying amount of that item as of December 31, 2025:
(€ million) | Gross value (e) | Accumulated amortization & impairment | December 31, 2025 | Amortization period (years)(a) | Residual amortization period (years)(b) | Carrying amount at December 31, 2024 | Carrying amount at December 31, 2023 |
Boehringer Ingelheim (c) (d) | |||||||
Chattem(c) (d) | |||||||
Protein Sciences(c) | ( | ||||||
Ablynx(c) | ( | ||||||
Bioverativ(c) | ( | ||||||
Rezurock | ( | ||||||
Tzield | ( | ||||||
Beyfortus | ( | ||||||
Ayvakit | ( | ||||||
Wayrilz | ( | ||||||
Qunol (d) | |||||||
Total: principal marketed products incl. Opella products presented in "Assets held for sale" as of December 31, 2024 and forming part of the Opella transaction in 2025 (see Note D.1.) | 22,119 | (7,389) | 14,730 | 14,697 | 15,676 | ||
Total: principal marketed products excl. Opella products presented in "Assets held for sale" as of December 31, 2024 and forming part of the Opella transaction in 2025 (see Note D.1.) | 11,752 | 12,647 |
(c)Commercialized products derived from the acquisition of these companies. In the case of Bioverativ, the product Enjaymo was sold to Recordati in 2024
(see Note D.1.).
(e) These items exclude Genzyme and Aventis assets, with gross values of €9,866 million and €28,453 million respectively, and carrying amounts of
During 2025, some of the acquired research and development came into commercial use, and started being amortized from the
date of marketing approval; the main item involved was Wayrilz (rilzabritunib), a treatment targeting BTK through multi-immune
modulation to help address the root causes of immune thrombocytopenia (ITP).
The main asset brought into service during 2023 was ALTUVIIIO (efanesoctocog alfa), a treatment for acute hemorrhages in
people with hemophilia A.
SANOFI FORM 20-F 2025 | F-43 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
Amortization of other intangible assets is recognized in the income statement within the line item Amortization of intangible
assets, except for amortization of software and other rights of an industrial or operational nature which is recognized in the
relevant classification of expense by function. An analysis of amortization of software is shown in the table below:
(€ million) | 2025 | 2024 | 2023(a) |
Cost of sales | |||
Research and development expenses | |||
Selling and general expenses | |||
Other operating expenses | |||
Net income from discontinued operations | |||
Total |
D.5. Impairment of intangible assets and property, plant and equipment
Goodwill
When testing goodwill annually for impairment, the recoverable amount is determined for the Biopharma segment on the basis of
value in use, as derived from discounted estimates of the future cash flows in accordance with the policies described in
Note B.6.1.
The value in use of the Biopharma segment was determined by applying an after-tax discount rate to estimated future after-tax
cash flows. The after-tax rate used for impairment testing of the Biopharma segment is determined on the basis of Sanofi's
weighted average cost of capital (WACC) ; it was 7.25 % in 2025.
The pre-tax discount rate applied to estimated pre-tax cash flows is calculated by iteration from the previously-determined value
in use; the rate for the Biopharma segment was 10.1 %.
The terminal value growth rate applied to future cash flows is determined so as to not exceed the projected long-term growth
rate for the industry. In 2025, the perpetual growth rate applied to future cash flows for the Biopharma segment was zero .
Sanofi also applies assumptions on the probability of success of current research and development projects, and more generally
on its ability to renew the product portfolio in the longer term.
The assumptions used in testing goodwill for impairment are reviewed annually.
Value in use (determined as described above) is compared with the carrying amount, and this comparison is then subject to
sensitivity analyses by reference to key parameters including:
•changes in the discount rate;
•changes in the perpetual growth rate; and
•fluctuations in operating margin.
No impairment of the goodwill would need to be recognized in the event of a reasonably possible change to the assumptions
used in 2025.
Other intangible assets
When there is evidence that an asset may have become impaired, the asset’s value in use is calculated by applying an after-tax
discount rate to the estimated future after-tax cash flows from that asset. Applying after-tax discount rates to after-tax cash
flows gives the same values in use as would be obtained by applying pre-tax discount rates to pre-tax cash flows.
The after-tax discount rates used for impairment testing of other intangible assets are obtained by adjusting Sanofi’s weighted
average cost of capital to reflect specific country and business risks. In 2025, after-tax discount rates were in a range from 7.25 %
to 8.25 %.
In most instances, there are no market data that would enable fair value less costs to sell to be determined other than by means
of developing a similar estimate based on future cash flows. Consequently, recoverable amount is in substance equal to value in
use. The estimates used to determine value in use are sensitive to assumptions specific to the nature of the asset and to Sanofi's
activities. Apart from the discount rate, the principal assumptions used in 2025 were as follows:
•mid-term and long-term forecasts;
•perpetual growth or attrition rates, when applicable; and
•probability of success of current research and development projects.
The assumptions used in testing intangible assets for impairment are reviewed at least annually.
F-44 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
impairment losses as shown below :
(€ million) | 2025 | 2024 | 2023 |
Impairment of other intangible assets, net of reversals (excluding software) | |||
Marketed products | ( | ||
Biopharma(a) | ( | ||
Research and development projects and technology platforms(b)(c)(d) | |||
Others |
targeting multiple sclerosis, reflecting the reduced probability of approval arising from the negative PERSEUS Phase 3 study results in Primary
Progressive Multiple Sclerosis (PPMS) and the recent interactions with the FDA and EMA on Secondary Progressive Multiple Sclerosis (SPMS). Other
impairment losses amounting to €522 million were also recorded against various other research and development projects.
(including a €239 million loss resulting from the decision taken in February 2025 to discontinue a Phase 3 clinical study investigating of a vaccine
candidate to prevent invasive E.coli disease) and (ii) an impairment reversal of €225 million recognized in connection with the disposal of the ProXTen
technology platform.
programs, in particular those related to the NK Cell and ProXTen technology platforms.
As required by IFRS 5, the other intangible assets of Opella were measured in accordance with IAS 36 immediately before their
reclassification as of December 31, 2024 as assets held for sale; this assessment did not result in any impairment of their carrying
amount being recognized.
Property, plant and equipment
Impairment losses taken against property, plant and equipment are disclosed in Note D.3.
Risks and opportunities related to climate change
Sanofi has identified specific plausible scenarios to assess climate risks and opportunities liable to impact its activities in the
medium and longer term.
These include:
•an Aggressive Mitigation scenario, based on global collaboration to start reducing emissions immediately to meet Paris
Agreement goals (limit temperature increase to 1.5°C above pre-industrial levels), generating risks related to transitioning to a
lower carbon economy and entailing extensive policy, legal, technology, and market changes to address mitigation and
adaptation requirements;
•a No Climate Action scenario (leading to global warming of 4°C above pre-industrial levels by 2100), with event-driven physical
risks resulting from climate change or longer term shifts in climate patterns leading to potential financial implications such as
direct damage to assets and indirect impacts from supply chain disruption; changes in water availability, and in the sourcing or
quality of resources; food security; and extreme temperature changes affecting premises, operations, supply chain, transport
needs, and employee safety; and
•a Most Likely scenario, encompassing fragmented regional efforts to start reducing emissions but not at a sufficient level to
meet Paris Agreement goals (emissions continue to increase but at a slowed rate, leading to a 2.8°C temperature increase).
This scenario presents risks related to the progressive intensification of physical impacts such as the increased frequency of
extreme weather events, rising sea levels, and more limited water resources. It may also generate economic and social
challenges, requiring adjustments in certain sectors, and leading to regulatory or legal developments that could influence
regional activities.
The importance and likelihood of such risks have been assessed and have not led Sanofi to identify any material impact that could
generate a risk of impairment of the assets of Sanofi’s CGUs.
SANOFI FORM 20-F 2025 | F-45 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
D.6. Investments accounted for using the equity method
Investments accounted for using the equity method comprise associates and joint ventures (see Note B.1.) and are set forth
below.
(€ million) | % interest | 2025 | 2024 | 2023 |
OPAL JV Co (a) | ||||
EUROAPI(b) | ||||
Infraserv GmbH & Co. Höchst KG(c) | ||||
MSP Vaccine Company(d) | ||||
Other investments | ||||
Total |
(a)Following the loss of control of Opella, Sanofi holds 48.2 % of the associate OPAL JV Co (CD&R holds 50 % and Bpifrance holds 1.8 %). As of December 31,
2025, the investment includes a €241 million loan to the associate OPAL JV Co being in substance part of the investment.
The table below shows Sanofi’s overall share of (i) profit or loss and (ii) other comprehensive income from investments accounted
for using the equity method, showing the split between associates and joint ventures in accordance with IFRS 12 (the amounts for
each individual associate or joint venture are not material, except for the associate OPAL JV Co as detailed hereafter):
2025 | 2024 | 2023 | ||||
(€ million) | Joint ventures | Associates(a) | Joint ventures | Associates(a) | Joint ventures | Associates(a) |
Share of profit/(loss) from investments accounted for using the equity method | ( | ( | ( | |||
Share of other comprehensive income from investments accounted for using the equity method | ( | ( | ( | |||
Total | ( | ( | ( | |||
2025, see Note D.1.) attributable to the equity holders of Sanofi; that amount includes the effects of the purchase price allocation, and of related fair
value adjustments to the identifiable assets and liabilities (mainly intangible assets and inventories).The investment in EUROAPI includes an impairment
loss determined by reference to the quoted market price (€2.27 as of December 31, 2025, €2.88 as of December 31, 2024 and €5.73 as of December 31,
2023).
The financial statements include arm’s length transactions between Sanofi and some equity-accounted investments that are
classified as related parties. The principal transactions and balances with related parties are summarized below:
(€ million) | 2025 | 2024 | 2023 |
Sales (c) (d) | |||
Royalties and other income(c) (d) | |||
Accounts receivable and other receivables (a) | |||
Other assets(b) | |||
Purchases and other expenses (including research expenses) (c) (d) | |||
Accounts payable and other liabilities |
investment as of December 31, 2025 is €143 million.
There were no
December 31, 2023.
F-46 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
For off balance sheet commitments of an operational nature involving joint ventures, see Note D.21.1.
accordance with Sanofi’s consolidation timelines, are presented below:
(€ million) | December 31, 2025 |
Consolidated income statement | |
Net sales and other revenues (a) | |
Net income (a) | ( |
Consolidated statement of comprehensive income | |
Other comprehensive income | |
Comprehensive income | ( |
April 30, 2025. For 2025, these amounts include transactions between Sanofi and the associate OPAL JV Co for the period from May 1, 2025 through
December 31, 2025.
(€ million) | December 31, 2025 |
Consolidated balance sheet | |
Non-current assets | |
Current assets | |
Total assets | |
Equity attributable to equity holders of the associate OPAL JV Co | |
Equity attributable to non-controlling interests | |
Total equity | |
Non-current liabilities | |
Current liabilities | |
Total liabilities | |
Total equity and liabilities |
D.7. Other non-current assets
(€ million) | 2025 | 2024 | 2023 |
Equity instruments at fair value through other comprehensive income (D.7.1.) | |||
Debt instruments at fair value through other comprehensive income (D.7.2.) | |||
Other financial assets at fair value through profit or loss (D.7.3.) | |||
Pre-funded pension obligations (Note D.19.1.) | |||
Long-term prepaid expenses | |||
Long-term loans and advances and other non-current receivables(a) | |||
Derivative financial instruments (Note D.20.) | |||
Total |
–a loan of €150 million to the BioAtrium joint venture which matures on December 1, 2031, of which €156 million was recognized in "Other current
assets" as of December 31, 2022;
–a receivable under a sub-lease amounting to €82 million (€116 million before discounting), versus €116 million (or €153 million before discounting) as of
D.7.1. Equity instruments at fair value through other comprehensive income
Quoted equity instruments
The line “Equity instruments at fair value through other comprehensive income” includes equity investments quoted in an active
market with a carrying amount of €869 million as of December 31, 2025, €467 million as of December 31, 2024 and €470 million
as of December 31, 2023.
The movement in quoted equity investments included in the “Equity instruments at fair value through other comprehensive
income” category in the year ended December 31, 2025 was mainly due to increases in the stock prices of quoted equity
investments, primarily an increase in the stock price of Innovent Biologics for €216 million.
SANOFI FORM 20-F 2025 | F-47 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
The main changes during previous years in quoted equity investments included in the “Equity instruments at fair value through
other comprehensive income” category are described below:
•in 2024: the movement in quoted equity investments included in the “Equity instruments at fair value through other
comprehensive income” was mainly due to Sanofi taking a non-controlling equity interest in Novavax in May 2024;
•in 2023: there were no material movements in quoted equity investments during the year ended December 31, 2023.
A 10 % decline in stock prices of the quoted equity investments included within “Equity instruments at fair value
through other comprehensive income” would have had a pre-tax impact of €87 million on Other comprehensive income as
of December 31, 2025.
Unquoted equity instruments
The line item “Equity instruments at fair value through other comprehensive income” also includes equity investments not quoted
in an active market with a carrying amount of €1,331 million as of December 31, 2025, €1,092 million as of December 31, 2024
and €618 million as of December 31, 2023.
The change in unquoted equity investments included in the “Equity instruments at fair value through other comprehensive
income” category during the year ended December 31, 2025 was mainly due various equity stakes acquired through the Sanofi
Ventures fund. It also includes the following items:
•an investment of €300 million relating to an equity interest of approximately 16 % in Orano Med Theranostics, a new entity
focused on the discovery, design, and clinical development of next-generation radioligand therapies (RLTs) based on lead-212
(212Pb) alpha-emitting isotopes. The fair value of this investment as of December 31, 2025 was €60 million, and the fair value
adjustment of €240 million) was recognized through Other comprehensive income; and
The change in unquoted equity investments included in the “Equity instruments at fair value through other comprehensive
income” category during the year ended December 31, 2024 was mainly due to an investment in EUROAPI in the form of a
perpetual subordinated hybrid bond, the value of which was €200 million at inception date and €143 million as of December 31,
2025 (versus €189 million as of December 31, 2024), plus various equity stakes acquired through the Sanofi Ventures fund.
In addition, commitments relating to equity investments classified in this asset category amounted to €110 million as of December
31, 2025 (versus €360 million as of December 31, 2024 and €65 million as of December 31, 2023).
D.7.2. Debt instruments at fair value through other comprehensive income
The “Debt instruments at fair value through other comprehensive income” category includes quoted euro-denominated senior
bonds amounting to €389 million as of December 31, 2025, including €90 million of securities obtained in exchange for financial
assets held to meet obligations to employees under post-employment benefit plans.
Sanofi held €357 million of quoted senior bonds as of December 31, 2024 and €346 million as of December 31, 2023.
As regards debt instruments held to meet obligations to employees under post-employment benefit plans, an increase of 10 basis
points in market interest rates as of December 31, 2025 would have had a pre-tax impact of €1 million on Other comprehensive
income.
As regards other quoted debt instruments, an increase of 10 basis points in market interest rates as of December 31, 2025 would
have had a pre-tax impact of €1 million on Other comprehensive income.
Other comprehensive income recognized in respect of “Equity instruments at fair value through other comprehensive income”
and “Debt instruments at fair value through other comprehensive income” represented unrealized after-tax gains of €415 million
for the year ended December 31, 2025, versus unrealized after-tax gains of €342 million for the year ended December 31, 2024
and of €349 million for the year ended December 31, 2023.
An analysis of the change in gains and losses recognized in Other comprehensive income, and of items reclassified to profit or
loss, is presented in Note D.15.7.
D.7.3. Other financial assets at fair value through profit or loss
The “Other financial assets at fair value through profit or loss” category mainly includes:
•a portfolio of financial investments (amounting to €688 million as of December 31, 2025) held to fund a deferred
compensation plan provided to certain employees (versus €688 million as of December 31, 2024 and €572 million as
of December 31, 2023);
•unquoted securities not meeting the definition of equity instruments amounting to €230 million as of December 31, 2025
(versus €165 million as of December 31, 2024 and €132 million as of December 31, 2023). In addition, commitments relating to
unquoted securities classified in this asset category amount to €205 million as of December 31, 2025 (compared to €168
million as of December 31, 2024); and
•contingent consideration receivable by Sanofi, amounting to €86 million as of December 31, 2025 (versus €174 million as of
December 31, 2024), recorded entirely as a non-current asset and including contingent consideration receivable recognized
following the sale of Enjaymo (see note D.1) based on the probability of achieving certain levels of future sales and discounted.
If the discount rate were to increase by one percentage point, the fair value of the Enjaymo contingent consideration would
F-48 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
decrease by approximately 6 %. Changes in the fair value of this contingent consideration are recognized within the income
statement line item Fair value remeasurement of contingent consideration (see note B.18.); and
•up to December 31, 2023, contingent consideration receivable by Sanofi following the dissolution of the Sanofi Pasteur MSD
(SPMSD) joint venture, based on a percentage of MSD’s future sales during the 2017-2024 period of specified products
D.8. Assets held for sale and liabilities related to assets held for sale
(€ million) | December 31, 2025 | December 31, 2024 | December 31, 2023 |
Opella (D.36.) | |||
Other | |||
Assets held for sale | |||
Opella (D.36.) | |||
Other | |||
Liabilities related to assets held for sale |
D.9. Inventories
2025 | 2024 | 2023 | |||||||
(€ million) | Gross value | Allowances | Carrying amount | Gross value | Allowances | Carrying amount | Gross value | Allowances | Carrying amount |
Raw materials | ( | ( | ( | ||||||
Work in process | ( | ( | ( | ||||||
Finished goods | ( | ( | ( | ||||||
Total | ( | ( | ( | ||||||
Allowances include write-downs of products on hand pending marketing approval, except in specific circumstances where it is
possible to estimate that recovery of the value of inventories as of the end of the reporting period is highly probable.
Following the Blueprint acquisition, a fair value remeasurement was recognized at the acquisition date on finished goods and
work-in-process inventories (see Note D.1.). The carrying amount of the fair value remeasurement is €991 million as of December
31, 2025.
D.10. Accounts receivable
(€ million) | December 31, 2025 | December 31, 2024 | December 31, 2023 |
Gross value | |||
Allowances | ( | ( | ( |
Carrying amount |
The impact of allowances against accounts receivable in 2025 was a net expense of €15 million (versus a net expense
of €19 million in 2024 and €8 million in 2023).
The gross value of overdue receivables was €468 million as of December 31, 2025, versus €650 million as of December 31, 2024
and €689 million as of December 31, 2023.
(€ million) | Overdue accounts gross value | Overdue by <1 month | Overdue by 1 to 3 months | Overdue by 3 to 6 months | Overdue by 6 to 12 months | Overdue by > 12 months |
December 31, 2025 | ||||||
December 31, 2024 | ||||||
December 31, 2023 |
Amounts overdue by more than one month relate mainly to public-sector customers.
Some Sanofi subsidiaries have assigned receivables to factoring companies or banks without recourse. The amount of
receivables derecognized was nil as of December 31, 2025 (€14 million as of December 31, 2024 and €761 million as
of December 31, 2023). The residual guarantees relating to such transfers were immaterial as of December 31, 2025.
SANOFI FORM 20-F 2025 | F-49 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
D.11. Other current assets
(€ million) | 2025 | 2024 | 2023 |
Tax receivables, other than corporate income taxes | |||
Prepaid expenses | |||
Other receivables(a) | |||
Currency derivatives measured at fair value (see Note D.20.) | |||
Other financial assets at fair value through profit or loss | |||
Other current financial assets(b) | |||
Total |
agreement.
item also includes debt instruments derived from the acquisition of Blueprint Medicines with maturities of more than 3 months at inception and less than
D.12. Financial assets and liabilities measured at fair value
Under IFRS 7 (Financial Instruments: Disclosures), fair value measurements must be classified using a fair value hierarchy with the
following levels:
•level 1: quoted prices in active markets for identical assets or liabilities (without modification or repackaging);
•level 2: quoted prices in active markets for similar assets and liabilities, or valuation techniques in which all important inputs are
derived from observable market data; and
•level 3: valuation techniques in which not all important inputs are derived from observable market data.
The valuation techniques used are described in Note B.8.5.
F-50 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
2025 | 2024 | 2023 | ||||||||
Level in the fair value hierarchy | Level in the fair value hierarchy | Level in the fair value hierarchy | ||||||||
(€ million) | Note | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
Financial assets measured at fair value | ||||||||||
Quoted equity investments | D.7.1. | |||||||||
Unquoted equity investments | D.7.1. | |||||||||
Quoted debt securities | D.7.2. | |||||||||
Unquoted debt securities not meeting the definition of equity instruments | D.7.3. | |||||||||
Contingent consideration relating to divestments | D.7.3. & D.11. | |||||||||
Financial assets held to meet obligations under deferred compensation plans | D.7.3. & D.11. | |||||||||
Non-current derivatives | D.7. | |||||||||
Current derivatives | D.11. | |||||||||
Mutual fund investments | D.13. | |||||||||
Total financial assets measured at fair value | ||||||||||
Financial liabilities measured at fair value | ||||||||||
MSD contingent consideration (European vaccines business) | D.18. | |||||||||
Shire contingent consideration arising from the acquisition of Translate Bio | D.18. | |||||||||
Contingent consideration arising from the acquisition of Amunix | D.18. | |||||||||
CVRs issued in connection with the acquisition of Blueprint | D.18. | |||||||||
CVRs issued in connection with the acquisition of Vigil | D.18. | |||||||||
Other contingent consideration arising from business combinations and acquisitions | D.18. | |||||||||
Non-current derivatives | D.20. | |||||||||
Current derivatives | D.19.5 | |||||||||
Total financial liabilities measured at fair value | ||||||||||
No transfers between the different levels of the fair value hierarchy occurred during 2025.
D.13. Cash and cash equivalents
(€ million) | 2025 | 2024 | 2023 |
Cash | |||
Cash equivalents(a) | |||
Cash and cash equivalents |
mutual funds (December 31, 2024: €4,161 million; December 31, 2023: €5,349 million); and (ii) €270 million of term deposits (December 31,
2024: €1,293 million; December 31, 2023: €1,191 million). Cash equivalents also include €490 million held by captive insurance and reinsurance companies
in accordance with insurance regulations (December 31, 2024: €446 million; December 31, 2023: €476 million).
SANOFI FORM 20-F 2025 | F-51 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
D.14. Net deferred tax position
(€ million) | 2025 | 2024 | 2023 | |
Deferred taxes on: | ||||
Consolidation adjustments (intragroup margin in inventory) | ||||
Provision for pensions and other employee benefits | ||||
Remeasurement of other acquired intangible assets | ( | (a) | ( | ( |
Recognition of acquired property, plant and equipment at fair value | ( | ( | ||
Equity interests in subsidiaries and investments in other entities(b) | ( | ( | ( | |
Tax losses available for carry-forward | ||||
Stock options and other share-based payments | ||||
Accrued expenses and provisions deductible at the time of payment(c) | ||||
Other(d) | ||||
Net deferred tax asset/(liability) |
(€151 million); and Blueprint Medicines (€1,443 million), acquired in 2025 (see Note D.1.).
deferred tax liability on the reserves of French and foreign subsidiaries (approximately €73.3 million) which it regards as likely to be distributed in the
foreseeable future. In determining the amount of the deferred tax liability as of December 31, 2025, Sanofi took into account changes in the ownership
structure of certain subsidiaries, and the effects of changes in the taxation of dividends in France, following the ruling of the Court of Justice of the EU in
the Steria case and the resulting amendments to the 2015 Finance Act. As of December 31, 2024, this line includes a deferred tax liability arising from
temporary differences on investments in subsidiaries in connection with the separation of Opella; that amount was fully reversed as of December 31,
2025 following the loss of control of Opella in April 2025 (see note D.1.).
2024, and €286 million as of December 31, 2023.
December 31, 2024, and €1,331 million as of December 31, 2023.
The reserves of Sanofi subsidiaries that would be taxable if distributed but for which no distribution is planned, and for which no
deferred tax liability has therefore been recognized, totaled €10.1 billion as of December 31, 2025, compared with €10.5 billion as
of December 31, 2024 and €10.0 billion as of December 31, 2023.
Most of Sanofi’s tax loss carry-forwards are available indefinitely. For a description of policies on the recognition of deferred tax
assets, refer to Note B.22. For each tax consolidation, the recognition of deferred tax assets is determined on the basis of profit
forecasts that are consistent with Sanofi’s medium-term strategic plan, and taking into consideration the tax consequences of
the strategic opportunities available to Sanofi within the period of availability of tax loss carry-forwards and the specific
circumstances of each tax consolidation. Deferred tax assets relating to tax loss carry-forwards as of December 31, 2025
amounted to €3,458 million, of which €1,622 million were not recognized (primarily composed of prior period tax liabilities
following progress of reviews with tax authorities and capital losses). This compares with €3,010 million as of December 31, 2024
(of which €2,039 million were not recognized) and €2,729 million as of December 31, 2023 (of which €1,203 million were not
recognized).
(€ million) | Tax losses available for carry-forward(a) |
2026 | |
2027 | |
2028 | |
2029 | |
2030 | |
2031 and later | |
Total as of December 31, 2025 | |
Total as of December 31, 2024 | |
Total as of December 31, 2023 |
Use of tax loss carry-forwards is limited to the entity in which they arose. In jurisdictions where tax consolidations are in place, tax
losses can be netted against taxable income generated by entities in the same tax consolidation.
Deferred tax assets not recognized because their future recovery was not regarded as probable given the expected results of the
entities in question and unagreed tax positions amounted to €1,620 million in 2025, €2,117 million in 2024 and €1,261 million in
2023.
F-52 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
D.15. Consolidated shareholders’ equity
D.15.1. Share capital
As of December 31, 2025, the share capital was €2,439,004,304 , consisting of 1,219,502,152 shares with a par value of €2 .
Number of shares (million) | % of share capital for the period | |
December 31, 2025 | ||
December 31, 2024 | ||
December 31, 2023 | ||
January 1, 2023 |
Treasury shares are deducted from shareholders’ equity. Gains and losses on disposals of treasury shares are recorded directly in
equity and are not recognized in net income for the period.
Date | Transaction | Number of shares |
December 31, 2022 | ||
During 2023 | Capital increase by exercise of stock subscription options(a) | |
During 2023 | Capital increase by issuance of restricted shares(b) | |
Board meeting of July 27, 2023 | Capital increase reserved for employees | |
December 31, 2023 | ||
During 2024 | Capital increase by exercise of stock subscription options(a) | |
During 2024 | Capital increase by issuance of restricted shares(b) | |
Board meeting of July 24, 2024 | Capital increase reserved for employees | |
Board meeting of December 4, 2024 | Reduction in share capital by cancellation of treasury shares | ( |
December 31, 2024 | ||
During 2025 | Capital increase by exercise of stock subscription options(a) | |
During 2025 | Capital increase by issuance of restricted shares(b) | |
Board meeting of March 13, 2025 | Reduction in share capital by cancellation of treasury shares | ( |
Board meeting of April 23, 2025 | Reduction in share capital by cancellation of treasury shares | ( |
Board meeting of July 30, 2025 | Reduction in share capital by cancellation of treasury shares | ( |
Board meeting of July 30, 2025 | Capital increase reserved for employees | |
Board meeting of December 10, 2025 | Reduction in share capital by cancellation of treasury shares | ( |
December 31, 2025 |
For the disclosures about the management of capital required under IFRS 7, refer to Note D.2.
SANOFI FORM 20-F 2025 | F-53 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
D.15.2. Restricted share plans
those plans are as follows:
2025 | 2024 | 2023 | ||||
Type of plan | Performance share plans | Performance share plans | Performance share plans | Performance share plans | Performance share plans | Performance share plans |
Date of Board meeting approving the plan | April 30, 2025 | October 23, 2025 | April 30, 2024 | December 4, 2024 | May 25, 2023 | December 13, 2023 |
Service period | ||||||
Total number of shares awarded(a) | ||||||
Of which with no market condition | ||||||
Fair value per share awarded(b) | € | € | € | € | € | € |
Of which with market condition | ||||||
Fair value per share awarded other than to the Chief Executive Officer(c) | € | € | € | € | € | € |
Fair value per share awarded other than to the Chief Executive Officer – additional shares(d) | € | € | € | € | ||
Fair value per share awarded to the Chief Executive Officer(c) | € | € | € | |||
Fair value of plan at the date of grant (€ million) | ||||||
dividends expected during the vesting period.
December 2024 (versus 121,097 awarded in May 2023 and 5,838 awarded in December 2023).
the table below:
2025 | 2024(a) | 2023(a) | |
Total expense for restricted share plans (€ million) | |||
Number of shares not yet fully vested as of December 31 | |||
Under 2025 plans | |||
Under 2024 plans | |||
Under 2023 plans | |||
Under 2022 plans | |||
Under 2021 plans |
D.15.3. Capital increases
in 2025, 2024 and 2023 are summarized in the table below:
2025 | 2024 | 2023 | |
Date of Board meeting approving the plan | January 29, 2025 | January 31, 2024 | February 2, 2023 |
Subscription price (€)(a) | |||
Subscription period | June 10-30, 2025 | June 4-24, 2024 | June 5-23, 2023 |
Number of shares subscribed | |||
Number of shares issued immediately as employer’s contribution |
(€ million) | 2025 | 2024 | 2023 |
Expense recognized | |||
of which employer’s contribution |
F-54 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
D.15.4. Repurchase of Sanofi shares
The Annual General Meetings of Sanofi shareholders held on April 30, 2025, April 30, 2024 and May 25, 2023 each authorized a
share repurchase program for a period of 18 The following repurchases have been made under those programs:
(in number of shares and € million) Year of authorization | 2025 | 2024 | 2023 | |||
Number of shares | Value | Number of shares | Value | Number of shares | Value | |
2025 program | — | — | — | — | ||
2024 program | — | — | ||||
2023 program | — | — | ||||
2022 program | — | — | — | — | ||
During the meeting of the Board of Directors on January 29, 2025, the Board authorized Sanofi to repurchase the Company's
shares, for an amount not exceeding €5 billion, under the terms and conditions set by the General Meeting of April 30, 2024 in its
19th resolution. As part of this authorization, Sanofi entered into a share buyback agreement with its historical shareholder L'Oréal
on February 2, 2025 for the acquisition of 2.34% of Sanofi’s share capital, equivalent to 29,556,650 shares, for a total amount of
approximately €3 billion, representing a price of €101.50 per share. The conclusion of that agreement was approved by the Board
of Directors on the same day prior to the signing of the agreement, and in accordance with the procedure set forth in Articles
L. 225-38 et seq. of the French Commercial Code.
D.15.5. Reductions in share capital
Reductions in share capital for the accounting periods presented are described in the table included at Note D.15.1. above.
Those reductions have no impact on shareholders’ equity.
D.15.6. Currency translation differences
(€ million) | 2025 | 2024 | 2023 |
Attributable to equity holders of Sanofi | ( | ( | |
Attributable to non-controlling interests | ( | ( | ( |
Total | ( | ( |
The balance as of December 31, 2025 includes an after-tax amount of €(440 ) million relating to hedges of net investments
in foreign operations (refer to Note B.8.3. for a description of the relevant accounting policy), compared with €(679 ) million as
of December 31, 2024 and €(574 ) million as of December 31, 2023.
As of December 31, 2024, this balance included an amount of €(300 ) million relating to translation differences of Opella, the
assets and liabilities of which are presented in Assets held for sale and Liabilities related to assets held for sale .
The movement in Currency translation differences is mainly attributable to the US dollar.
SANOFI FORM 20-F 2025 | F-55 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
D.15.7. Other comprehensive income
(€ million) | 2025 | 2024 | 2023 |
Actuarial gains/(losses): | |||
•Actuarial gains/(losses) excluding investments accounted for using the equity method (see Note D.19.1.) | ( | ||
•Actuarial gains/(losses) of investments accounted for using the equity method, net of taxes | ( | ||
•Tax effects | ( | ( | |
Equity instruments included in financial assets and financial liabilities: | |||
•Change in fair value (excluding investments accounted for using the equity method) | ( | ||
•Change in fair value (investments accounted for using the equity method, net of taxes) | |||
•Equity risk hedging instruments designated as fair value hedges | |||
•Tax effects | ( | ( | |
Items not subsequently reclassifiable to profit or loss (a) | ( | ( | |
Debt instruments included in financial assets: | |||
•Change in fair value (excluding investments accounted for using the equity method)(b) | |||
•Tax effects | ( | ( | |
Cash flow and fair value hedges: | |||
•Change in fair value (excluding investments accounted for using the equity method)(c) | ( | ( | |
•Change in fair value (investments accounted for using the equity method, net of taxes) | ( | ( | |
▪Tax effects | |||
Change in currency translation differences: | |||
•Currency translation differences on foreign subsidiaries (excluding investments accounted for using the equity method)(d) | ( | ( | |
•Currency translation differences (investments accounted for using the equity method)(d) | ( | ||
•Hedges of net investments in foreign operations(d) | ( | ||
•Tax effects | ( | ( | |
Items subsequently reclassifiable to profit or loss(e) | ( | ( |
2023.
2024 and €(56 ) million in 2023. Currency translation differences arise from the translation into euros of the financial statements of foreign subsidiaries,
and are mainly due to the depreciation of the dollar against the euro.
€(78 ) million in 2023.
F-56 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
D.15.8. Stock options
Stock option plans awarded and measurement of stock option plans
No stock options were awarded during 2025, 2024 or 2023.
Stock subscription option plans
Details of the terms of exercise of stock subscription options granted under the various plans are presented below in Sanofi share
equivalents. These plans were awarded to certain corporate officers and employees of Sanofi companies.
ended December 31, 2025:
Source | Date of grant | Number of options granted | Start date of exercise period | Expiry date | Exercise price (€) | Number of options outstanding as of 12/31/2025 |
Sanofi | 06/24/2015 | 06/25/2019 | 06/24/2025 | |||
Sanofi | 05/04/2016 | 05/05/2020 | 05/04/2026 | |||
Sanofi | 05/10/2017 | 05/11/2021 | 05/10/2027 | |||
Sanofi | 05/02/2018 | 05/03/2022 | 05/02/2028 | |||
Sanofi | 04/30/2019 | 05/01/2023 | 04/30/2029 | |||
Total |
The exercise of all outstanding stock subscription options would increase shareholders’ equity by approximately €57 million.
The exercise of each option results in the issuance of one share.
Summary of stock option plans
below:
Number of options | Weighted average exercise price per share (€) | Total (€ million) | |
Options outstanding at January 1, 2023 | |||
Options exercisable | |||
Options exercised | ( | ( | |
Options outstanding at December 31, 2023 | |||
Options exercisable | |||
Options exercised | ( | ( | |
Options outstanding at December 31, 2024 | |||
Options exercisable | |||
Options exercised | ( | ( | |
Options forfeited | ( | ( | |
Options outstanding at December 31, 2025 | |||
Options exercisable |
Outstanding | Exercisable | ||||
Range of exercise prices per share | Number of options | Weighted average residual life (years) | Weighted average exercise price per share (€) | Number of options | Weighted average exercise price per share (€) |
From € | |||||
From € | |||||
From € | |||||
Total | |||||
SANOFI FORM 20-F 2025 | F-57 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
D.15.9. Number of shares used to compute diluted earnings per share
Diluted earnings per share is computed using the number of shares outstanding plus stock options with dilutive effect and
restricted shares.
(million) | 2025 | 2024 | 2023 |
Average number of shares outstanding | |||
Adjustment for stock options with dilutive effect | |||
Adjustment for restricted shares | |||
Average number of shares used to compute diluted earnings per share |
In 2025, 2024 and 2023, all stock options were taken into account in computing diluted earnings per share because they all had a
D.16. Non-controlling interests
Non-controlling interests did not represent a material component of Sanofi’s consolidated financial statements in the years
D.17. Debt, cash and cash equivalents and lease liabilities
D.17.1. Debt, cash and cash equivalents
(€ million) | 2025 | 2024 | 2023 |
Long-term debt | |||
Short-term debt and current portion of long-term debt | |||
Interest rate and currency derivatives used to manage debt | |||
Total debt | |||
Cash and cash equivalents | ( | ( | ( |
Interest rate and currency derivatives used to manage cash and cash equivalents | ( | ( | |
Net debt(a) |
“Net debt” is a non-IFRS financial measure used by management and investors to measure Sanofi’s overall net indebtedness.
Value on redemption | ||||||
(€ million) | Carrying amount at December 31, 2025 | Amortized cost | Adjustment to debt measured at fair value | December 31, 2025 | December 31, 2024 | December 31, 2023 |
Long-term debt | ||||||
Short-term debt and current portion of long-term debt | ||||||
Interest rate and currency derivatives used to manage debt | ( | ( | ||||
Total debt | ( | |||||
Cash and cash equivalents | ( | ( | ( | ( | ||
Interest rate and currency derivatives used to manage cash and cash equivalents | ( | ( | ( | |||
Net debt | ( | |||||
F-58 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
a) Principal financing transactions during the year
Cash flows from financing activities | Non-cash items | ||||||||
(€ million) | December 31, 2024 | Repayments | New borrowings | Other cash flows(a) | Currency translation differences(b) | Reclassification from non-current to current | Other items(c) | December 31, 2025 | |
Long-term debt | ( | ( | ( | ||||||
Short-term debt and current portion of long-term debt | ( | ( | |||||||
Interest rate and currency derivatives used to manage debt | ( | ( | ( | ||||||
Total debt | ( | ( | ( | ||||||
exchange gains and losses, €2 million of which was recognized in "Other comprehensive income" following the designation of bonds and commercial
paper as a hedge of Sanofi’s net investment in the US. The notional amount of those hedging instruments was $3,000 million for the bonds (maturities
between 2027 and 2032), and $1,000 million for the commercial paper (maturity 2026).
value remeasurements.
Sanofi carried out the following bond issues during the period:
•March 2025: a bond issue of €1.5 billion in two tranches:
–€850 million of floating-rate bonds maturing March 2027, with quarterly coupons and bearing interest at an annual rate of
3-month Euribor plus 30 basis points; and
– €650 million of fixed-rate bonds maturing March 2031, with annual coupons and bearing interest at an annual rate of
2.750%.
•June 2025: a bond issue of €1.5 billion in two tranches:
–€750 million of fixed-rate bonds maturing June 2029, with annual coupons and bearing interest at an annual rate of
2.625%; and
–€750 million of fixed-rate bonds maturing June 2032, with annual coupons and bearing interest at an annual rate of
3.000%.
•November 2025: a bond issue of $3.0 billion in five tranches:
–$400 million of fixed-rate bonds maturing November 2027, with bi-annual coupons and bearing interest at an annual rate
of 3.750%; and
–$500 million of floating-rate bonds maturing November 2027, with quarterly coupons and bearing interest at an annual
rate of capitalized SOFR plus 0.46%;
–$400 million of fixed-rate bonds maturing November 2028, with bi-annual coupons and bearing interest at an annual rate
of 3.800%; and
–$500 million of floating-rate bonds maturing November 2028, with quarterly coupons and bearing interest at an annual
rate of capitalized SOFR plus 0.54%; and
–$1,200 million of fixed-rate bonds maturing November 2032, with bi-annual coupons and bearing interest at an annual rate
of 4.200%.
• the €1 billion fixed-rate bond issue from April 2020, which was redeemed at maturity on April 1, 2025;
•the €850 million fixed-rate bond issue from April 2022, which was redeemed at maturity on April 6, 2025; and
• the €750 million fixed-rate bond issue from September 2015, which was redeemed at maturity on September 22, 2025;
As of December 31, 2025,Sanofi had two syndicated credit facilities linked to social and environmental criteria in place to manage
its liquidity in connection with current operations:
•a €4 billion facility maturing December 6, 2027, with no further extension option available; and
•a €4 billion facility maturing March 6, 2030, with no further extension option available.
SANOFI FORM 20-F 2025 | F-59 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
In line with Sanofi’s commitment to embed sustainable development in its strategy, those two revolving credit facilities build in an
adjustment mechanism that links the credit spread to the attainment of two sustainable development performance indicators:
(i) Sanofi’s contribution to improving access to essential medicines in low-income and intermediate-income countries via its
Sanofi Global Health non-profit unit, and (ii) the reduction in Sanofi’s carbon footprint.
Cash flows from financing activities | Non-cash items | ||||||||
(€ million) | December 31, 2023 | Repayments | New borrowings | Other cash flows(a) | Currency translation differences(b) | Reclassification from non-current to current | Other items(c) | December 31, 2024 | |
Long-term debt | ( | ( | |||||||
Short-term debt and current portion of long-term debt | ( | ( | |||||||
Interest rate and currency derivatives used to manage debt | ( | ( | |||||||
Total debt | ( | ( | |||||||
Cash flows from financing activities | Non-cash items | ||||||||
(€ million) | December 31, 2022 | Repayments | New borrowings | Other cash flows (a) | Currency translation differences (b) | Reclassification from non-current to current | Other items(c) | December 31, 2023 | |
Long-term debt | ( | ( | ( | ||||||
Short-term debt and current portion of long-term debt | ( | ( | |||||||
Interest rate and currency derivatives used to manage debt | ( | ( | |||||||
Total debt | ( | ( | |||||||
b) Net debt by type, at value on redemption
2025 | 2024 | 2023 | |||||||
(€ million) | Non- current | Current | Total | Non- current | Current | Total | Non- current | Current | Total |
Bond issues | |||||||||
Other bank borrowings | |||||||||
Other borrowings | |||||||||
Bank credit balances | |||||||||
Interest rate and currency derivatives used to manage debt | ( | ( | |||||||
Total debt | |||||||||
Cash and cash equivalents | ( | ( | ( | ( | ( | ( | |||
Interest rate and currency derivatives used to manage cash and cash equivalents | ( | ( | ( | ( | |||||
Net debt(a) | ( | ( | ( | ||||||
F-60 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
Issuer | ISIN code | Issue date | Maturity | Annual interest rate | Amount (€ million) | Type |
Sanofi | FR0013324340 | 03/21/2018 | 03/21/2018 | EMTN Program | ||
Sanofi | FR0012146801 | 09/10/2014 | 09/10/2026 | EMTN Program | ||
Sanofi | FR0013201639 | 09/13/2016 | 01/13/2027 | EMTN Program | ||
Sanofi | FR001400Y1H8 | 03/11/2025 | 03/11/2027 | EMTN Program | ||
Sanofi | FR0013144003 | 04/05/2016 | 04/05/2028 | EMTN Program | ||
Sanofi | FR0013409844 | 03/21/2019 | 03/21/2029 | EMTN Program | ||
Sanofi | FR0014009KQ0 | 04/06/2022 | 04/06/2029 | Standalone Prospectus | ||
Sanofi | FR0014010MQ4 | 06/23/2025 | 06/23/2029 | EMTN Program | ||
Sanofi | FR0013324357 | 03/21/2018 | 03/21/2030 | EMTN Program | ||
Sanofi | FR0013505112 | 04/09/2020 | 04/01/2030 | EMTN Program | ||
Sanofi | FR0013505112 | 03/30/2020 | 04/01/2030 | EMTN Program | ||
Sanofi | FR001400Y116 | 03/11/2025 | 03/11/2031 | EMTN Program | ||
Sanofi | FR0014010MR2 | 06/23/2025 | 06/23/2032 | EMTN Program | ||
Sanofi | FR0013409851 | 03/21/2019 | 03/21/2034 | EMTN Program | ||
Sanofi | FR0013324373 | 03/21/2018 | 03/21/2038 | EMTN Program |
Bond issues denominated in US dollars carried out by Sanofi under the public bond issue program (shelf registration statement)
registered with the US Securities and Exchange Commission (SEC) comprise:
Issuer | ISIN code | Issue date | Maturity | Annual interest rate | Amount ($ million) | Type |
Sanofi | US801060AF19 | 11/3/2025 | 11/3/2027 | SOFR+ | SEC REGISTERED | |
Sanofi | US801060AE44 | 11/3/2025 | 11/3/2027 | SEC REGISTERED | ||
Sanofi | US801060AD60 | 6/19/2018 | 6/19/2028 | SEC REGISTERED | ||
Sanofi | US801060AH74 | 11/3/2025 | 11/3/2028 | SOFR+ | SEC REGISTERED | |
Sanofi | US801060AG91 | 11/3/2025 | 11/3/2028 | SEC REGISTERED | ||
Sanofi | US801060AJ31 | 11/3/2025 | 11/3/2032 | SEC REGISTERED |
In order to manage its liquidity needs for current operations, as of December 31, 2025 Sanofi had:
•a syndicated credit facility of €4 billion, drawable in euros and in US dollars, maturing December 6, 2027; and
•a syndicated credit facility of €4 billion, drawable in euros and in US dollars, maturing March 6, 2030.
Sanofi also has two commercial paper programs:
•a €6 billion Negotiable European Commercial Paper program in France, with an average drawdown of €0.1 billion and a
maximum drawdown of €0.2 billion during 2025. As of December 31, 2025, this program was not being utilized; and
•a $10 billion Commercial Paper program in the US, with an average drawdown of $3.8 billion and a maximum drawdown of $6.8
billion during 2025, and an amount of $1.0 billion drawn down as of December 31, 2025.
The financing in place as of December 31, 2025 at the level of the holding company (which manages most of Sanofi’s financing
needs centrally) is not subject to any financial covenants, and contains no clauses linking spreads or fees to the credit rating.
SANOFI FORM 20-F 2025 | F-61 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
c) Debt by maturity, at value on redemption
December 31, 2025 | Current | Non-current | |||||
(€ million) | Total | 2026 | 2027 | 2028 | 2029 | 2030 | 2031 and later |
Bond issues | |||||||
Other bank borrowings | |||||||
Other borrowings | |||||||
Bank credit balances | |||||||
Interest rate and currency derivatives used to manage debt | |||||||
Total debt | |||||||
Cash and cash equivalents | ( | ( | |||||
Interest rate and currency derivatives used to manage cash and cash equivalents | ( | ( | |||||
Net debt(a) | ( | ||||||
and €2,030 million as of December 31, 2023 (see the maturity analysis at Note D.17.2.).
As of December 31, 2025, the undrawn confirmed general-purpose credit facilities at holding company level amounted to €8
billion, half of which expires in 2027 and the other half of which expires in 2030.
As of December 31, 2025, no single counterparty represented more than 6% of Sanofi’s undrawn confirmed credit facilities.
December 31, 2024 | Current | Non-current | |||||
(€ million) | Total | 2025 | 2026 | 2027 | 2028 | 2029 | 2030 and later |
Bond issues | |||||||
Other bank borrowings | |||||||
Other borrowings | |||||||
Bank credit balances | |||||||
Interest rate and currency derivatives used to manage debt | |||||||
Total debt | |||||||
Cash and cash equivalents | ( | ( | |||||
Interest rate and currency derivatives used to manage cash and cash equivalents | |||||||
Net debt | ( | ||||||
December 31, 2023 | Current | Non-current | |||||
(€ million) | Total | 2024 | 2025 | 2026 | 2027 | 2028 | 2029 and later |
Bond issues | |||||||
Other bank borrowings | |||||||
Other borrowings | |||||||
Bank credit balances | |||||||
Interest rate and currency derivatives used to manage debt | ( | ( | |||||
Total debt | |||||||
Cash and cash equivalents | ( | ( | |||||
Interest rate and currency derivatives used to manage cash and cash equivalents | ( | ( | |||||
Net debt | ( | ||||||
F-62 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
d) Debt by interest rate, at value on redemption
values on redemption, before the effects of derivative instruments:
(€ million) | Total | 2026 | 2027 | 2028 | 2029 | 2030 | 2031 and later |
Fixed-rate debt | |||||||
of which euro | |||||||
of which US dollar | |||||||
% fixed-rate | |||||||
Floating-rate debt | |||||||
of which euro | |||||||
of which US dollar | |||||||
% floating-rate | |||||||
Debt | |||||||
Cash and cash equivalents | ( | ( | |||||
of which euro | ( | ||||||
of which US dollar | ( | ||||||
% floating-rate | |||||||
Net debt | ( |
Sanofi issues debt in two currencies, the euro and the US dollar, and also invests its cash and cash equivalents in those currencies.
Sanofi also operates cash pooling arrangements to manage the surplus cash and short-term liquidity needs of foreign subsidiaries
located outside the euro zone.
uses derivative instruments (interest rate swaps, currency swaps, foreign exchange swaps and forward contracts) that alter the
fixed/floating rate split and the currency split of its net debt:
(€ million) | Total | 2026 | 2027 | 2028 | 2029 | 2030 | 2031 and later |
Fixed-rate debt | |||||||
of which euro | |||||||
of which US dollar | |||||||
% fixed-rate | |||||||
Floating-rate debt | |||||||
of which euro | |||||||
of which US dollar | |||||||
% floating-rate | |||||||
Debt | |||||||
Cash and cash equivalents | ( | ( | |||||
of which euro | ( | ||||||
of which US dollar | ( | ||||||
of which Singapore dollar | ( | ||||||
% floating-rate | |||||||
Net debt | ( |
instruments as of December 31, 2024 and December 31, 2023:
(€ million) | 2024 | % | 2023 | % |
Fixed-rate debt | ||||
Floating-rate debt | ||||
Debt | ||||
Cash and cash equivalents | ( | ( | ||
Net debt |
The weighted average interest rate on debt as of December 31, 2025 was 2.2 % before derivative instruments and 3.2 % after
derivative instruments. Cash and cash equivalents were invested as of December 31, 2025 at an average rate of 3.4 % before
derivative instruments and 3.5 % after derivative instruments.
SANOFI FORM 20-F 2025 | F-63 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
Change in short-term interest rates | Impact on pre-tax net income (€ million) | Impact on pre-tax income/(expense) recognized directly in equity (€ million) |
+100 bp | ||
+25 bp | ||
-25 bp | ( | ( |
-100 bp | ( | ( |
e) Debt by currency, at value on redemption
convert the foreign-currency net debt of exposed entities into their functional currency:
(€ million) | Before derivative instruments | After derivative instruments |
Euro | ||
US dollar | ( | |
Pound sterling | ( | |
Singapore dollar | ( | ( |
Chinese yuan renminbi | ( | ( |
Other currencies | ( | ( |
Net debt |
the foreign currency net debt of exposed entities into their functional currency:
(€ million) | 2024 | 2023 |
Euro | ||
US dollar | ||
Other currencies | ( | ( |
Net debt |
f) Market value of net debt
(€ million) | 2025 | 2024 | 2023 |
Market value | |||
Value on redemption |
The fair value of net debt is determined by reference to quoted market prices at the balance sheet date in the case of quoted
instruments (level 1 in the IFRS 7 hierarchy, see Note D.12.), and by reference to the fair value of interest rate and currency
derivatives used to manage net debt (level 2 in the IFRS 7 hierarchy, see Note D.12.).
g) Future contractual cash flows relating to debt and related derivatives
derivative instruments designated as hedges of debt:
December 31, 2025 | Payments due by period | ||||||
(€ million) | Total | 2026 | 2027 | 2028 | 2029 | 2030 | 2031 and later |
Debt | |||||||
Principal | |||||||
Interest(a) | |||||||
Net cash flows related to derivative instruments | ( | ||||||
Total | |||||||
Future contractual cash flows are shown on the basis of the carrying amount in the balance sheet at the reporting date, without
reference to any subsequent management decision that might materially alter the structure of Sanofi’s debt or its hedging policy.
F-64 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
derivative instruments designated as hedges of debt as of December 31, 2024 and 2023:
December 31, 2024 | Payments due by period | ||||||
(€ million) | Total | 2025 | 2026 | 2027 | 2026 | 2029 | 2030 and later |
Debt | |||||||
Principal | |||||||
Interest(a) | |||||||
Net cash flows related to derivative instruments | |||||||
Total | |||||||
December 31, 2023 | Payments due by period | ||||||
(€ million) | Total | 2024 | 2025 | 2026 | 2027 | 2028 | 2029 and later |
Debt | |||||||
Principal | |||||||
Interest(a) | |||||||
Net cash flows related to derivative instruments | |||||||
Total | |||||||
D.17.2. Lease liabilities
Undiscounted future minimum lease payments | ||||||
(€ million) | Total | Less than 1 year | From 1 to 3 years | From 3 to 5 years | More than 5 years | Discounting effect |
Total lease liabilities as of December 31, 2025(a) | ( | |||||
Total lease liabilities as of December 31, 2024 | ( | |||||
Total lease liabilities as of December 31, 2023 | ( | |||||
Lease liabilities include leases relating to real estate assets located at Cambridge, MA (US), which have a lease term of 15 years.
SANOFI FORM 20-F 2025 | F-65 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
D.18. Liabilities related to business combinations and to non-controlling interests
For a description of the nature of the liabilities reported in the line item Liabilities related to business combinations and to
non-controlling interests, refer to Note B.8.5. The principal acquisitions are described in Notes D.1. and D.2.
The liabilities related to business combinations and to non-controlling interests shown in the table below are level 3 instruments
under the IFRS 7 fair value hierarchy (see Note D.12.).
(€ million) | Bayer contingent consideration arising from the acquisition of Genzyme | MSD contingent conside- ration (European Vaccines business) | Shire contingent consideration arising from the acquisition of Translate Bio | Contingent conside- ration arising from acquisition of Amunix | CVRs issued in connection with the acquisition of Blueprint | CVRs issued in connection with the acquisition of Vigil | Other | Total(a) |
Balance at January 1, 2023 | ||||||||
New transactions | ||||||||
Payments made | ( | ( | ( | ( | ||||
Fair value remeasurements through profit or loss: (gain)/loss (including unwinding of discount)(b) | ( | |||||||
Other movements | ||||||||
Currency translation differences | ( | ( | ( | |||||
Balance at December 31, 2023 | ||||||||
New transactions | ||||||||
Payments made | ( | ( | ( | |||||
Fair value remeasurements through profit or loss: (gain)/loss (including unwinding of discount)(b) | ||||||||
Other movements | ( | ( | ( | |||||
Currency translation differences | ( | |||||||
Balance at December 31, 2024 | ||||||||
New transactions | ||||||||
Payments made | ( | ( | ||||||
Fair value remeasurements through profit or loss: (gain)/loss (including unwinding of discount)(b) | ||||||||
Other movements | ||||||||
Currency translation differences | ( | ( | ( | ( | ||||
Balance at December 31, 2025 |
2023); portion due within less than one year: €0 million as of December 31, 2025 (€72 million as of December 31, 2024 and €208 million as
of December 31, 2023).
As of December 31, 2025, Liabilities related to business combinations and to non-controlling interests mainly comprised:
•Following the acquisition of Blueprint in July 2025, Blueprint shareholders received one non-tradable contingent value right
(CVR) entitling the holder to receive two potential milestone payments of $2 and $4 per CVR on the attainment of future
development and regulatory milestones, respectively, for the BLU-808 project, currently in development; the nominal value of
the contingent consideration is $448 million.
•Following the acquisition of Vigil in August 2025, Vigil shareholders received one non-tradable contingent value right (CVR)
entitling the holder to receive a potential milestone payment of $2 per CVR contingent upon the first commercial sales of
VG-3927; the nominal value of the contingent consideration is $114 million.
•A contingent consideration liability towards Shire Human Genetic Therapies Inc. (Shire) arising from Sanofi’s acquisition of
Translate Bio in September 2021. In a business combination carried out in December 2016 and predating the acquisition of
control by Sanofi, Translate Bio (then called Rana Therapeutics, Inc.) acquired from Shire the intellectual property rights
relating to the latter’s Messenger RNA Therapeutics (MRT) program. As of December 31, 2025, Shire was entitled to receive the
following potential payments:
–milestone payments contingent on the launch of products based on MRT technology, and on the attainment of a specified
level of sales of those products, and
–a percentage of sales of those products.
F-66 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
The fair value of the Shire liability was measured at €531 million as of December 31, 2025, compared with €568 million as
of December 31, 2024 and €441 million as of December 31, 2023; it was determined by applying the contractual terms to
development and sales projections which were weighted to reflect the probability of success, and discounted. If the discount
rate were to fall by one percentage point, the fair value of the Shire liability would increase by approximately 11 %.
•Following the exclusive licensing agreement on the ProXTen technology platform entered into with Vir Biotechnology in
September 2024 , Inc., Sanofi no longer has any contingent consideration liability arising from the acquisition of Amunix in
2022. The fair value of that contingent consideration liability was €137 million as of December 31, 2023.
•The MSD contingent consideration liability arising from Sanofi’s acquisition of the Sanofi Pasteur activities carried on within the
former Sanofi Pasteur MSD joint venture was extinguished during 2025 in accordance with the contractual terms. Sanofi has
no further liability in respect of this contingent consideration following settlement of the milestone linked to 2024 sales.
As of December 31, 2025, there is no contingent consideration payable in respect of already-marketed products.
The nominal amount of contingent consideration was €72 million as of December 31, 2024 and €133 million as of December 31,
2023.
D.19. Provisions, income tax liabilities and other liabilities
(€ million) | 2025 | 2024 | 2023 |
Provisions | |||
Other non-current liabilities(a) | |||
Total |
2023.
The figure as of December 31, 2025 includes €1,560 million for the liability in respect of royalties payable to Sobi on net sales of Beyfortus (nirsevimab) in
the US (see Note C.2.). Given the method used to calculate royalties payable, an increase or decrease in sales forecasts would lead to a proportionate
change in the amount of the liability. The nominal value of payments estimated to be due within more than one year but less than five years is
€869 million; the nominal value of payments estimated to be due after more than five years is €2,062 million.
Non-current income tax liabilities are described in Note D.19.4., and other current liabilities in Note D.19.5.
SANOFI FORM 20-F 2025 | F-67 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
(€ million) | Provisions for pensions and other post- employment benefits (D.19.1.) | Provisions for other long-term benefits | Liabilities related to restructuring operations (D.19.2.) | Other provisions (D.19.3.) | Total | ||
Balance at January 1, 2023 | |||||||
Increases in provisions | (a) | ||||||
Provisions utilized | ( | (a) | ( | ( | ( | ( | |
Reversals of unutilized provisions | ( | (a) | ( | ( | ( | ( | |
Transfers | ( | ( | ( | ( | |||
Net interest related to employee benefits, and unwinding of discount | |||||||
Currency translation differences | ( | ( | ( | ( | |||
Actuarial gains and losses on defined-benefit plans | |||||||
Balance at December 31, 2023 | |||||||
Changes in scope of consolidation | |||||||
Increases in provisions | (a) | ||||||
Provisions utilized | ( | (a) | ( | ( | ( | ( | |
Reversals of unutilized provisions | ( | (a) | ( | ( | ( | ||
Transfers | ( | ( | ( | ( | |||
Net interest related to employee benefits, and unwinding of discount | |||||||
Currency translation differences | ( | ||||||
Actuarial gains and losses on defined-benefit plans | ( | ( | |||||
Opella reclassification (b) | ( | ( | ( | ( | ( | ||
Balance at December 31, 2024 | |||||||
Changes in scope of consolidation | |||||||
Increases in provisions | (a) | ||||||
Provisions utilized | ( | (a) | ( | ( | ( | ( | |
Reversals of unutilized provisions | ( | (a) | ( | ( | ( | ||
Transfers | ( | ( | ( | ( | |||
Net interest related to employee benefits, and unwinding of discount | |||||||
Currency translation differences | ( | ( | ( | ( | ( | ||
Actuarial gains and losses on defined-benefit plans | ( | ( | |||||
Balance at December 31, 2025 |
employees during the period, and past service cost; the “Provisions utilized” line corresponds to contributions paid into pension funds and to
beneficiaries; and the “Reversals of unutilized provisions” line corresponds to plan curtailments, settlements and amendments.
Liabilities related to assets held for sale in accordance with IFRS 5 (see Note D.1.).
D.19.1. Provisions for pensions and other post-employment benefits
Sanofi offers its employees pension plans and other post-employment benefit plans. The specific features of the plans (benefit
formulas, fund investment policy and fund assets held) vary depending on the applicable laws and regulations in each country
where the employees work. These employee benefits are accounted for in accordance with IAS 19 (see Note B.23.).
Sanofi’s pension obligations in four major countries represented approximately 88 % of the total value of the defined-benefit
obligation and approximately 87 % of the total value of plan assets as of December 31, 2025. The features of the principal defined-
benefit plans in each of those four countries are described below.
France
Lump-sum retirement benefit plans
All employees working for Sanofi in France are entitled on retirement to a lump-sum payment, the amount of which depends both
on their length of service and on the rights guaranteed by collective and internal agreements. The employee’s final salary is used
in calculating the amount of these lump-sum retirement benefits. These plans represent approximately 40 % of Sanofi’s total
obligation in France.
F-68 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
Defined-benefit pension plans
These plans provide benefits from the date of retirement. Employees must fulfil a number of criteria to be eligible for these
benefits. All of these plans are now closed. These plans represent approximately 60 % of Sanofi’s total obligation in France.
Germany
Top-up defined-benefit pension plan
The benefits offered under this pension plan are wholly funded by the employer (there are no employee contributions) via a
Contractual Trust Agreement (CTA) and a cross border Institution for Occupational Retirement Provision (IORP) domiciled in
Belgium, under which benefits are estimated on the basis of a career average salary. Employees are entitled to receive an annuity
under this plan if their salary exceeds the social security ceiling. The amount of the pension is calculated by reference to a range
of vesting rates corresponding to salary bands. The plan also includes disability and death benefits. This plan represents
approximately 62 % of Sanofi’s total obligation in Germany.
Sanofi-Aventis plus (SAV plus)
A top-up pension plan (SAV plus) replaced a previous top-up defined-benefit plan. New entrants joining the plan after
April 1, 2015 contribute to a defined-contribution plan that is partially funded via the company’s CTA.
All employees whose salary exceeds the social security ceiling are automatically covered by the plan. The employer’s contribution
is 14 % of the amount by which the employee’s salary exceeds the social security ceiling.
Multi-employer plan (Pensionskasse)
This is a defined-benefit plan treated as a defined-contribution plan, in accordance with the accounting policies described
in Note B.23. Currently, contributions cover the level of annuities. Only the portion relating to the future revaluation
of the annuities is included in the defined-benefit pension obligation. The obligation relating to this revaluation amounted
to €624 million as of December 31, 2025, versus €682 million as of December 31, 2024 and €744 million as of December 31, 2023.
This plan represents approximately 25 % of Sanofi’s total defined-benefit obligation in Germany.
United States
Defined-benefit pension plans
In the United States, there are two types of defined-benefit plan:
•“qualified” plans within the meaning of the Employee Retirement Income Security Act of 1974 (ERISA), which provide
guaranteed benefits to eligible employees during retirement, and in the event of death or disability. Employees can elect to
receive a reduced annuity, in exchange for an annuity to be paid in the event of their death to a person designated by them.
An annuity is also granted under the plan if the employee dies before retirement age. Eligible employees do not pay any
contributions. These plans are closed to new entrants, and the vesting of rights for future service periods is partially frozen.
These plans represent approximately 59 % of Sanofi’s total obligation in the US;
•“non-qualified” plans within the meaning of ERISA provide top-up retirement benefits to some eligible employees depending
on the employee’s level of responsibility and subject to a salary cap. These plans represent approximately 17 % of Sanofi’s total
obligation in the US.
Healthcare cover and life insurance
Sanofi companies provide some eligible employees with healthcare cover and life insurance during the retirement period (the
company’s contributions are capped at a specified level). These plans represent approximately 24 % (or €301 million) of Sanofi’s
total obligation and 2 % (or €13 million) of total plan assets in the US.
United Kingdom
Defined-benefit pension plans
Sanofi operates a number of pension plans in the United Kingdom that reflect past acquisitions. The most significant
arrangements are defined-benefit plans that have been closed since October 1, 2015. With effect from that date, employees can
no longer pay into these plans.
Under these defined-benefit plans, an annuity is paid from the retirement date. This annuity is calculated on the basis of the
employee’s length of service as of September 30, 2015, and of the employee’s final salary (or salary on the date he or she leaves
Sanofi).
The rates used for the vesting of rights vary from member to member. For most members, rights vest at the rate of 1.25 % or 1.50 %
of final salary for each qualifying year of service giving entitlement. The notional retirement age varies according to the category
to which the member belongs, but in most cases retirement is at age 65 . Members may choose to retire before or after the
notional retirement age (60 years), in which case the amount of the annual pension is adjusted to reflect the revised estimate of
the length of the retirement phase. Pensions are usually indexed to the Retail Price Index (RPI). Members paid a fixed-percentage
contribution into their pension plan (the percentage varied according to the employee category), and the employer topped up
the contribution to the required amount. These plans represent approximately 100 % of Sanofi’s total obligation in the United
Kingdom.
SANOFI FORM 20-F 2025 | F-69 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
In November 2024, a bulk annuity purchase transaction, commonly known as a “buy-in”, was executed for the main
defined-benefit pension scheme in the United Kingdom covering the majority of uninsured pension liabilities. Through this
transaction, and in conjunction with the previous pensioner buy-in executed in 2021, the main defined-benefit pension plan in the
United Kingdom is largely insured against investment, longevity, interest rate and inflation risks. Pension obligations will be
funded by the insurer’s annuity payments and the buy-in policies are held as an asset of the pension scheme. The pension
scheme retains full legal responsibility to pay the benefits to plan participants using insurance payments. The insurance contract
is deemed to be the present value of the matched obligations. In early 2025, Sanofi completed a further buy-in covering the
remaining uninsured liabilities meaning all members of the scheme are now fully insured by the transaction, except those arising
from guaranteed minimum pensions equalization.
For service periods subsequent to October 1, 2015, employees belong to a new defined-contribution plan.
Actuarial assumptions used to measure Sanofi’s obligations
Actuarial valuations of Sanofi’s benefit obligations were computed by management with assistance from external actuaries as
of December 31, 2025, 2024 and 2023.
2025 | 2024 | 2023 | ||||||||||
France | Germany | US | UK | France | Germany | US | UK | France | Germany | US | UK | |
Discount rate(a)(b) | ||||||||||||
General inflation rate(c) | — | — | — | |||||||||
Pension benefit indexation | — | — | — | |||||||||
Healthcare cost inflation rate(d) | — | to | — | — | — | to | — | — | — | — | ||
Retirement age | to | to | to | to | to | to | to | to | to | |||
Mortality table | TGH/ TGF 05 | Heubeck RT 2018 G | RP2012 Proj. MP2021 White Collar | SAPS S3 adj. | TGH/ TGF 05 | Heubeck RT 2018 G | RP2012 Proj. MP2021 White Collar | SAPS S3 | TGH/ TGF 05 | Heubeck RT 2018 G | RP2012 Proj. MP2021 White Collar | SAPS S3 |
under the plans. The benchmarks used to determine discount rates were the same for all periods presented.
Weighted average duration of obligation for pensions and other long-term benefits in principal
countries
2025 | 2024 | 2023 | ||||||||||
(years) | France | Germany | US | UK | France | Germany | US | UK | France | Germany | US | UK |
Weighted average duration | ||||||||||||
Sensitivity analysis
actuarial assumptions:
(€ million) | Pensions and other post-employment benefits, by principal country | ||||
Measurement of defined-benefit obligation | Change in assumption | France | Germany | US | UK |
Discount rate | - | + | + | + | + |
General inflation rate | + | + | + | + | |
Pension benefit indexation | + | + | + | + | |
Healthcare cost inflation rate | + | + | + | ||
Mortality table | +1 year | + | + | + | + |
F-70 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
amounts recognized in the consolidated financial statements:
Pensions and other post-employment benefits | |||
(€ million) | 2025 | 2024 | 2023 |
Measurement of the obligation: | |||
Beginning of period | |||
Current service cost | |||
Interest cost | |||
Actuarial losses/(gains) due to changes in demographic assumptions | ( | ( | |
Actuarial losses/(gains) due to changes in financial assumptions | ( | ( | |
Actuarial losses/(gains) due to experience adjustments | ( | ||
Plan amendments, curtailments or settlements not specified in the terms of the plan(b) | ( | ( | ( |
Plan settlements specified in the terms of the plan | ( | ( | ( |
Benefits paid | ( | ( | ( |
Changes in scope of consolidation and transfers | ( | ||
Currency translation differences | ( | ( | |
Opella reclassification | ( | ||
Obligation at end of period | |||
Fair value of plan assets: | |||
Beginning of period | |||
Interest income on plan assets | |||
Difference between actual return and interest income on plan assets(c) | ( | ||
Administration costs | ( | ( | ( |
Plan settlements specified in the terms of the plan | ( | ( | ( |
Plan settlements not specified in the terms of the plan | ( | ( | |
Contributions from plan members | |||
Employer’s contributions | |||
Benefits paid | ( | ( | ( |
Changes in scope of consolidation and transfers | ( | ( | |
Currency translation differences | ( | ||
Opella reclassification | ( | ||
Fair value of plan assets at end of period | |||
Net amount shown in the balance sheet: | |||
Net obligation | |||
Effect of asset ceiling | |||
Net amount shown in the balance sheet at end of period | |||
Amounts recognized in the balance sheet: | |||
Pre-funded obligations (see Note D.7.)(a) | ( | ( | ( |
Obligations provided for | |||
Net amount recognized at end of period | |||
Benefit cost for the period:(d) | |||
Current service cost | |||
(Gains)/losses related to plan amendments, curtailments or settlements not specified in the terms of the plan | ( | ( | ( |
Net interest (income)/cost | |||
Contributions from plan members | ( | ( | ( |
Administration costs and taxes paid during the period | |||
Expense recognized directly in profit or loss | |||
Remeasurement of net defined-benefit (asset)/liability (actuarial gains and losses)(b) | ( | ( | |
Expense/(gain) for the period | ( | ||
related to assets held for sale as of December 31, 2024.
SANOFI FORM 20-F 2025 | F-71 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
region:
(€ million) | Pensions and other post-employment benefits by geographical region | |||||
December 31, 2025 | France | Germany | US | UK | Other | Total |
Measurement of obligation | ||||||
Fair value of plan assets | ||||||
Effect of asset ceiling | ( | ( | ||||
Net amount shown in the balance sheet at end of period | ||||||
(€ million) | Pensions and other post-employment benefits by geographical region | |||||
December 31, 2024 | France | Germany | US | UK | Other | Total |
Measurement of obligation | ||||||
Fair value of plan assets | ||||||
Effect of asset ceiling | ( | ( | ||||
Net amount shown in the balance sheet at end of period | ||||||
(€ million) | Pensions and other post-employment benefits by geographical region | |||||
December 31, 2023 | France | Germany | US | UK | Other | Total |
Measurement of obligation | ||||||
Fair value of plan assets | ||||||
Effect of asset ceiling | ( | ( | ||||
Net amount shown in the balance sheet at end of period | ( | |||||
category:
2025 | 2024 | 2023 | |
Securities quoted in an active market | |||
Cash and cash equivalents | |||
Equity instruments | |||
Bonds and similar instruments | |||
Real estate | |||
Derivatives | - | ||
Commodities | |||
Other | |||
Other securities | |||
Hedge funds | |||
Insurance policies | |||
Total |
Sanofi has a long-term objective of maintaining or increasing the extent to which its pension obligations are covered by assets.
To this end, Sanofi uses an asset-liability management strategy, matching plan assets to its pension obligations. This policy aims
to ensure the best fit between the assets held on the one hand, and the associated liabilities and expected future payments to
plan members on the other. To meet this aim, Sanofi operates a risk monitoring and management strategy (mainly focused on
interest rate risk and inflation risk), while investing a growing proportion of assets in high-quality bonds with comparable
maturities to those of the underlying obligations and in contracts entered into with leading insurance companies to fund certain
post-employment benefit obligations.
F-72 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
(€ million) | Pensions and other post-employment benefits by geographical region | |||||
Service cost for 2025 | France | Germany | US | UK | Other | Total |
Current service cost | ||||||
(Gains)/losses related to plan amendments, curtailments or settlements not specified in the terms of the plan | ( | ( | ( | ( | ||
Net interest cost/(income) including administration costs and taxes paid during the period | ||||||
Contributions from plan members | ( | ( | ||||
Expense/(gain) recognized directly in profit or loss | ||||||
Remeasurement of net defined-benefit (asset)/liability (actuarial gains and losses) | ( | ( | ( | ( | ( | |
Expense/(gain) for the period | ( | ( | ( | |||
(€ million) | Pensions and other post-employment benefits by geographical region | |||||
Service cost for 2024 | France | Germany | US | UK | Other | Total |
Current service cost | ||||||
(Gains)/losses related to plan amendments, curtailments or settlements not specified in the terms of the plan | ( | ( | ( | ( | ||
Net interest cost/(income) including administration costs and taxes paid during the period | ( | |||||
Contributions from plan members | ( | ( | ||||
Expense/(gain) recognized directly in profit or loss | ( | ( | ||||
Remeasurement of net defined-benefit (asset)/liability (actuarial gains and losses) | ( | ( | ( | ( | ( | |
Expense/(gain) for the period | ( | ( | ( | |||
(€ million) | Pensions and other post-employment benefits by geographical region | |||||
Service cost for 2023 | France | Germany | US | UK | Other | Total |
Current service cost | ||||||
(Gains)/losses related to plan amendments, curtailments or settlements not specified in the terms of the plan | ( | ( | ( | |||
Net interest cost/(income) including administration costs and taxes paid during the period | ( | |||||
Contributions from plan members | ( | ( | ||||
Expense/(gain) recognized directly in profit or loss | ( | |||||
Remeasurement of net defined-benefit (asset)/liability (actuarial gains and losses) | ||||||
Expense/(gain) for the period | ||||||
is set forth below:
(€ million) | 2025 | 2024 | 2023 | |||||||||
France | Germany | US | UK | France | Germany | US | UK | France | Germany | US | UK | |
Actuarial gains/(losses) arising during the period | ( | ( | ( | ( | ( | ( | ||||||
Comprising: | ||||||||||||
Gains/(losses) on experience adjustments(a) | ( | ( | ( | ( | ( | ( | ( | |||||
Gains/(losses) on demographic assumptions | ( | |||||||||||
Gains/(losses) on financial assumptions | ( | ( | ( | ( | ( | |||||||
presented below:
(€ million) | 2025 | 2024 | 2023 |
Net pre-tax actuarial loss | ( | ( | ( |
SANOFI FORM 20-F 2025 | F-73 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
reporting period is shown below:
(€ million) | 2025 | 2024 | 2023 |
Present value of wholly or partially funded obligations in respect of pension and other post-employment benefit plans | |||
Present value of unfunded obligations | |||
Total |
statement line items as follows:
(€ million) | 2025 | 2024 | 2023 |
Cost of sales | |||
Research and development expenses | |||
Selling and general expenses | |||
Other operating (income)/expenses, net | ( | ||
Restructuring costs | ( | ( | ( |
Financial expenses | |||
Net income from discontinued operations | |||
Total |
(€ million) | France | Germany | US | UK | Other | Total |
Employer’s contributions in 2025 (estimate): | ||||||
2026 |
future years:
(€ million) | France | Germany | US | UK | Other | Total |
Estimated future benefit payments | ||||||
2026 | ||||||
2027 | ||||||
2028 | ||||||
2029 | ||||||
2030 | ||||||
2031 to 2035 |
other post-employment benefit plans:
Payments due by period | |||||
(€ million) | Total | Less than 1 year | 1 to 3 years | 3 to 5 years | More than 5 years |
Estimated payments | |||||
F-74 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
D.19.2. Liabilities related to restructuring operations
(€ million) | 2025 | 2024 | 2023 |
Balance, beginning of period | |||
Of which: | |||
•Classified in non-current liabilities | |||
•Classified in current liabilities | |||
Change in provisions recognized in profit or loss for the period | |||
Provisions utilized(a) | ( | ( | ( |
Transfers | ( | ||
Unwinding of discount | |||
Currency translation differences | ( | ( | |
Opella reclassification(b) | ( | ||
Balance, end of period | |||
Of which: | |||
•Classified in non-current liabilities | |||
•Classified in current liabilities |
(see Note D.1.).
Provisions for employee termination benefits as of December 31, 2025 amounted to €1,107 million (compared with €1,318 million
as of December 31, 2024 and €968 million as of December 31, 2023).
The provisions apply mainly to France, and relate to various voluntary redundancy programs:
•Sanofi’s Strategic Orientations in France for the period 2024–2026, announced in March 2024, which provide for internal
transfer and outplacement opportunities for employees whose jobs are subject to transformation, and include an end-of-
career paid leave component and an external retraining component. Implementation of this plan began in 2024 under the
terms of the Jobs Management and Career Paths (GEPP) agreement signed in 2022 and applicable until December 31, 2024. In
May 2025, a new GEPP agreement was signed for a period of four years until June 30, 2029. This new agreement aims to give
added impetus to job mobility, and to provide further internal and external support for employees with "sensitive" job profiles.
The provisions initially recognized were re-estimated during the 2025 financial year to reflect the newly signed agreement;
•Sanofi’s Strategic Orientations in France for the period 2022–2024, announced in June 2022, which provide for internal
transfer and outplacement opportunities for employees whose jobs are subject to transformation, and include an end-of-
career paid leave component and an external retraining component. Implementation of this plan began in 2022 under the
terms of the Jobs Management and Career Paths (GEPP) agreement relating to several French legal entities, signed in
February 2022 and applicable until December 31, 2024. Increases in provisions recognized in 2023 reflect an update to the
scope of “sensitive” job profiles; reversals were mainly due to the adoption of the Borne law, which raised the retirement age
to 64, and hence disqualified some participants eligible under previous legislation (in light of the maximum period for portage
workers);
•a voluntary redundancy program announced in 2024 in connection with the reorganization of R&D operations to make Sanofi
a leader in immunology, including an end-of-career paid leave plan and an end-of-career transition plan; and
•collectively agreed separation programs involving a number of legal entities announced at the end of June 2020 as part of the
rollout of the “Play to Win” strategy; these include an end-of-career paid leave plan and an external retraining program, and
were still ongoing during 2025. The same applies to Sanofi-Aventis Recherche & Développement, which announced a
voluntary redundancy program associated with R&D reorganization in 2020, and implemented that program in 2021.
The provision includes the present values of:
•gross annuities for self-funded plans;
•employer’s social security charges on early retirement annuities for all plans (outsourced and self-funded); and
•the levy charged on those annuities under the “Fillon” law (only for plans with termination of employment contracts).
The average residual portage periods under these plans were 2.26 years, 2.18 years and 2.22 years as of December 31, 2025, 2024
and 2023, respectively.
The main other countries covered by restructuring provisions are Germany, Japan and the US.
SANOFI FORM 20-F 2025 | F-75 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
December 31, 2025 | Benefit payments by period | ||||
(€ million) | Total | Less than 1 year | 1 to 3 years | 3 to 5 years | More than 5 years |
Employee termination benefits | |||||
•France | |||||
•Other countries | |||||
Total | |||||
December 31, 2024 | Benefit payments by period | ||||
(€ million) | Total | Less than 1 year | 1 to 3 years | 3 to 5 years | More than 5 years |
Employee termination benefits | |||||
•France | |||||
•Other countries | |||||
Total | |||||
December 31, 2023 | Benefit payments by period | ||||
(€ million) | Total | Less than 1 year | 1 to 3 years | 3 to 5 years | More than 5 years |
Employee termination benefits | |||||
•France | |||||
•Other countries | |||||
Total | |||||
D.19.3. Other provisions
(€ million) | 2025 | 2024 | 2023 |
Environmental risks | |||
Product liability risks, litigation and other | |||
Total |
Provisions for environmental risks relate primarily to contingencies arising from business divestitures, and include remediation
costs relating to such environmental risks.
Identified environmental risks are covered by provisions estimated on the basis of the costs Sanofi believes it will be obliged to
meet over a period not exceeding (other than in exceptional cases) 30 years. Sanofi expects that €56 million of those provisions
will be utilized in 2026, and €279 million over the period from 2027 through 2030.
As regards greenhouse gas emission quotas, which relate to Sanofi production facilities in France and Ireland, in the absence of
specific IFRS pronouncements Sanofi has adopted the "net liability approach". That involves recognizing a liability at the balance
sheet date if actual emissions exceed the quotas held, in accordance with IAS 37 and French GAAP (Plan Comptable Général,
Article 615-1s). Quotas are managed as a production cost, and as such are recognized in inventory at a zero value (if received free
of charge) and at acquisition cost (if bought on the market). As of December 31, 2025, a provision of €1 million has been
recognized.
“Product liability risks, litigation and other” mainly comprises provisions for risks relating to product liability (including IBNR
provisions as described in Note B.12.), government investigations, regulatory or antitrust law claims, contingencies arising from
business divestitures (other than environmental risks), and remediation costs related to leases.
The main pending legal and arbitral proceedings and government investigations are described in Note D.22.
A full risk and litigation assessment is performed with the assistance of Sanofi’s legal advisers, and provisions are recorded as
required by circumstances in accordance with the principles described in Note B.12.
F-76 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
D.19.4. Non-current income tax liabilities
Non-current income tax liabilities amounted to €2,081 million as of December 31, 2025 (versus €1,512 million as of December 31,
2024 and €1,842 million as of December 31, 2023). These amounts include uncertainties over income tax treatment totalling
€2,081 million as of December 31, 2025, versus €1,512 million as of December 31, 2024 and €1,595 million as of December 31, 2023.
Until December 31, 2023, this line item includes the residual liability due after more than one year arising from the estimated tax
charge on deemed repatriation attributable to the accumulated earnings of non-US operations (€247 million as of December 31,
2023). The expense was initially recognized in 2018 at an amount of $1,092 million, and payment is being made over eight years
through 2025.
A US legal restructuring resulted in a capital loss of €3 billion recognized in the 2020 final tax filing. One-third of the capital loss
has been used against 2020 capital gains and the remaining balance has been carried back on the 2017 capital gains. Due to
management’s judgment about potential alternative interpretations of the prevailing tax law, no tax benefit has been recognized
on this transaction in accordance with IFRIC 23.
D.19.5. Current provisions and other current liabilities
(€ million) | 2025 | 2024 | 2023 |
Taxes payable, other than corporate income taxes | |||
Employee-related liabilities | |||
Liabilities related to restructuring operations (see Note D.19.2.) | |||
Interest rate derivatives (see Note D.20.) | |||
Currency derivatives (see Note D.20.) | |||
Equity derivatives (see Note D.20.) | |||
Amounts payable for acquisitions of non-current assets | |||
Customer contract liabilities | |||
Other current liabilities (a) (b) | |||
Total |
healthcare authorities and governmental programs (see Note D.23.); and the liability payable at each reporting date under the Monoclonal Antibody
Alliance with Regeneron.
D.20. Derivative financial instruments and market risks
(€ million) | Non- current assets | Current assets | Total assets | Non-current liabilities | Current liabilities | Total liabilities | Market value at December 31, 2025 (net) | Market value at December 31, 2024 (net) | Market value at December 31, 2023 (net) |
Currency derivatives | ( | ( | ( | ( | ( | ||||
operating | ( | ( | ( | ( | |||||
financial | ( | ( | ( | ( | |||||
Interest rate derivatives | ( | ( | ( | ( | ( | ||||
Equity derivatives | |||||||||
Total | ( | ( | ( | ( | ( | ( |
Objectives of the use of derivative financial instruments
Sanofi uses derivative instruments to manage operating exposure to movements in exchange rates, and financial exposure to
movements in interest rates and exchange rates (where the debt or receivable is not contracted in the functional currency of the
borrower or lender entity). On occasion, Sanofi uses equity derivatives in connection with the management of its portfolio of
equity investments.
Sanofi performs periodic reviews of its transactions and contractual agreements in order to identify any embedded derivatives,
which are accounted for separately from the host contract in accordance with IFRS 9. Sanofi had no material embedded
derivatives as of December 31, 2025, 2024 or 2023.
SANOFI FORM 20-F 2025 | F-77 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
Counterparty risk
For a description of counterparty risk, refer to “Item 11. — Quantitative and Qualitative Disclosures about Market Risk”.
a) Currency derivatives used to manage operating risk exposures
For a description of Sanofi’s objectives, policies and procedures for the management of operating foreign exchange risk, refer to
“Item 11. — Quantitative and Qualitative Disclosures about Market Risk”.
translated into euros at the relevant closing exchange rate:
December 31, 2025 | Of which derivatives designated as cash flow hedges | Of which derivatives not eligible for hedge accounting | |||||
(€ million) | Notional amount | Fair value | Notional amount | Fair value | Of which recognized in equity | Notional amount | Fair value |
Forward currency sales | ( | ( | |||||
of which US dollar | |||||||
of which Singapore dollar | |||||||
of which Chinese yuan renminbi | ( | ( | |||||
of which Saudi Arabian riyal | |||||||
of which Turkish lira | ( | ( | |||||
Forward currency purchases | ( | ( | |||||
of which US dollar | ( | ( | |||||
of which Singapore dollar | ( | ( | |||||
of which Chinese yuan renminbi | |||||||
of which Turkish lira | |||||||
of which Hungarian forint | |||||||
Total | ( | ( | |||||
translated into euros at the relevant closing exchange rate:
December 31, 2024 | Of which derivatives designated as cash flow hedges | Of which derivatives not eligible for hedge accounting | |||||
(€ million) | Notional amount | Fair value | Notional amount | Fair value | Of which recognized in equity | Notional amount | Fair value |
Forward currency sales | ( | ( | |||||
of which US dollar | ( | ( | |||||
of which Chinese yuan renminbi | ( | ( | |||||
of which Pound sterling | ( | ( | |||||
of which Japanese yen | |||||||
of which Turkish lira | ( | ( | |||||
Forward currency purchases | |||||||
of which US dollar | |||||||
of which Singapore dollar | |||||||
of which Chinese yuan renminbi | |||||||
of which Turkish lira | |||||||
of which Canadian dollar | |||||||
Total | ( | ( | |||||
F-78 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
The table below shows operating currency hedging instruments in place as of December 31, 2023, with the notional amount
translated into euros at the relevant closing exchange rate:
December 31, 2023 | Of which derivatives designated as cash flow hedges | Of which derivatives not eligible for hedge accounting | |||||
(€ million) | Notional amount | Fair value | Notional amount | Fair value | Of which recognized in equity | Notional amount | Fair value |
Forward currency sales | |||||||
of which US dollar | |||||||
of which Chinese yuan renminbi | |||||||
of which Japanese yen | ( | ( | |||||
of which Singapore dollar | ( | ( | |||||
of which Korean won | ( | ( | |||||
Forward currency purchases | ( | ( | |||||
of which US dollar | ( | ( | |||||
of which Singapore dollar | |||||||
of which Chinese yuan renminbi | ( | ( | |||||
of which Korean won | |||||||
of which Japanese yen | |||||||
Total | |||||||
b) Currency and interest rate derivatives used to manage financial exposure
For a description of Sanofi’s objectives, policies and procedures for the management of financial foreign exchange risk and
interest rate risk, refer to “Item 11. — Quantitative and Qualitative Disclosures about Market Risk”.
relevant closing exchange rate:
2025 | 2024 | 2023 | ||||||||
(€ million) | Notional amount | Fair value | Expiry | Notional amount | Fair value | Expiry | Notional amount | Fair value | Expiry | |
Cross currency seller swaps | ||||||||||
of which US dollar | (a) | 2032 | ||||||||
Forward currency sales | ( | ( | ||||||||
of which US dollar | (b) | 2027 | ( | 2025 | 2024 | |||||
of which Pound sterling | ( | 2026 | 2025 | ( | 2024 | |||||
of which Japanese yen | 2026 | ( | 2025 | 2024 | ||||||
Forward currency purchases | ( | |||||||||
of which US dollar | (c) | 2026 | 2025 | ( | 2024 | |||||
of which Singapore dollar | ( | 2026 | 2025 | ( | 2024 | |||||
of which Hungarian forint | 2026 | ( | 2025 | 2024 | ||||||
Total | ( | |||||||||
with a notional amount of $870 million, pay 4.53% in US dollars and receive 3.00% in euros, expiring 2032, designated as a hedge of Sanofi’s net
investment in the US. As of December 31, 2025, the fair value of the swaps was an asset of €6 million, with €9 million credited to Other comprehensive
income and €3 million debited to financial income and expenses.
As of December 31, 2025, the fair value of these forward contracts represented a liability of €30 million, of which €30 million debited to Other
comprehensive income, with the impact on financial income and expenses being immaterial.
of bond issues to fluctuations in the EUR/USD spot rate. As of December 31, 2025, the fair value of the contracts was an asset of €3 million, of which
€1 million was credited to Other comprehensive income under the cost of hedging accounting treatment.
SANOFI FORM 20-F 2025 | F-79 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
Notional amounts by expiry date as of December 31, 2025 | Of which designated as fair value hedges | Of which designated as cash flow hedges | |||||||||||
(€ million) | 2026 | 2027 | 2028 | 2029 | 2030 | 2031 and later | Total | Fair value | Notional amount | Fair value | Notional amount | Fair value | Of which recognized in equity |
Interest rate swaps | |||||||||||||
pay 2.08% / receive Euribor 3M | ( | ( | |||||||||||
Pay 3.77% / receive capitalized SOFR + 46bps | |||||||||||||
pay capitalized SOFR USD/ receive 1.03% | ( | ( | |||||||||||
pay capitalized SOFR USD/ receive 1.32% | ( | ( | |||||||||||
pay 3.82% / receive capitalized SOFR + 54 bps | |||||||||||||
pay capitalized Ester/receive 0.92% | ( | ( | |||||||||||
Total | ( | ( | ( | ||||||||||
The table below shows interest rate hedging instruments in place as of December 31, 2024:
Notional amounts by expiry date as of December 31, 2024 | Of which designated as fair value hedges | Of which designated as cash flow hedges | |||||||||||
(€ million) | 2025 | 2026 | 2027 | 2028 | 2029 | 2030 and later | Total | Fair value | Notional amount | Fair value | Notional amount | Fair value | Of which recognized in equity |
Interest rate swaps | |||||||||||||
pay capitalized SOFR USD/ receive | ( | ( | |||||||||||
pay capitalized SOFR USD/ receive | ( | ( | |||||||||||
pay capitalized Ester/receive | ( | ( | |||||||||||
pay capitalized Ester/receive | ( | ( | |||||||||||
Total | ( | ( | |||||||||||
The table below shows interest rate hedging instruments in place as of December 31, 2023:
Notional amounts by expiry date as of December 31, 2023 | Of which designated as fair value hedges | Of which designated as cash flow hedges | |||||||||||
(€ million) | 2024 | 2025 | 2026 | 2027 | 2028 | 2029 and later | Total | Fair value | Notional amount | Fair value | Notional amount | Fair value | Of which recognized in equity |
Interest rate swaps | |||||||||||||
pay capitalized SOFR USD/ receive | ( | ( | |||||||||||
pay capitalized SOFR USD/ receive | ( | ( | |||||||||||
pay capitalized Ester/receive | ( | ( | |||||||||||
pay capitalized Ester/receive | ( | ( | |||||||||||
pay capitalized Ester/receive | ( | ( | |||||||||||
Total | ( | ( | |||||||||||
F-80 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
c) Actual or potential effects of netting arrangements
(€ million) | 2025 | 2024 | 2023 | |||
Derivative financial assets | Derivative financial liabilities | Derivative financial assets | Derivative financial liabilities | Derivative financial assets | Derivative financial liabilities | |
Gross carrying amounts before offset (a) | ( | ( | ( | |||
Gross amounts offset (in accordance with IAS 32) (b) | ||||||
Net amounts as reported in the balance sheet (a) - (b) = (c) | ( | ( | ( | |||
Effects of other netting arrangements (not fulfilling the IAS 32 criteria for offsetting) (d) | ||||||
Financial instruments | ( | ( | ( | |||
Fair value of financial collateral | N/A | N/A | N/A | N/A | N/A | N/A |
Net exposure (c) + (d) | ( | ( | ( | |||
D.21. Off balance sheet commitments
The off balance sheet commitments presented below are shown at their nominal value.
D.21.1. Off balance sheet commitments relating to operating activities
December 31, 2025 | Payments due by period | ||||
(€ million) | Total | Less than 1 year | 1 to 3 years | 3 to 5 years | More than 5 years |
Leases with a term of less than 12 months, low value asset leases and lease contracts committed but not yet commenced(a) | |||||
Irrevocable purchase commitments(b) | |||||
•given(c) | |||||
•received | ( | ( | ( | ( | ( |
Research and development license agreements – commitments given | |||||
•commitments related to R&D and other commitments(d) | |||||
•contingent milestone payments in connection with development programs in progress(e) | |||||
Total – net commitments given | |||||
commitments as of December 31, 2024 was €554 million.
During 2024, Sanofi signed a 12-year lease in France which will take effect in 2027, representing a commitment of €203 million.
down-payments (see Note D.3.), and to make or receive payments under agreements to provide or receive goods or services. As of December 31, 2024,
irrevocable commitments amounted to €3,683 million given and €391 million received.
commitment to EUROAPI. amounting to €238 million as of December 31, 2025, and (ii) commitments related to long-term renewable energy purchase
contracts lasting between 15 and 20 years giving rise to the physical supply of electricity mainly in France for an estimated total annual volume of
329 GWh.
€4,230 million. These commitments include contingent milestone payments in connection with purchases of groups of assets amounting to €2,119 million
as of December 31, 2025 (of which €1,107 million related to the acquisition of Dren-0201, Inc and €383 million related to the acquisition of Vicebio Ltd. -
In pursuance of its strategy, Sanofi may acquire technologies and rights to products. Such acquisitions may be made in various
contractual forms: acquisitions of shares, loans, license agreements, joint development, and co-marketing. These arrangements
generally involve upfront payments on signature of the agreement, development milestone payments, and royalties. Some of
these complex agreements include undertakings to fund research programs in future years and payments contingent upon
achieving specified development milestones, the granting of approvals or licenses, or the attainment of sales targets once a
product is commercialized.
SANOFI FORM 20-F 2025 | F-81 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
The “Research and development license agreements” line comprises future service commitments to fund research and
development or technology, and contingent milestone payments regarded as reasonably achievable (i.e. all potential milestone
payments relating to projects in the development phase, for which the future financial consequences are known or probable and
for which there is a sufficiently reliable estimate). This line excludes:
•commitments given relating to (i) projects in the research phase, amounting to €13.9 billion as of December 31, 2025 and
€14.4 billion as of December 31, 2024 and (ii) payments contingent upon the attainment of sales targets once a product is
commercialized, amounting to €15.6 billion as of December 31, 2025 and €15.2 billion as of December 31, 2024;
•commitments received amounting to €9.0 billion as of December 31, 2025 (€12.5 billion as of December 31, 2024),
mainly comprising research, development and commercialization agreements with partners further to the acquisitions
of (i) Ablynx (€0.7 billion as of December 31, 2025, versus €0.7 billion as of December 31, 2024) and (ii) Kymab (€0.2 billion as
of December 31, 2025, versus €0.3 billion as of December 31, 2024), plus contingent consideration receivable based on
attainment of regulatory and sales milestones for commercialized products under the terms of licenses or rights assignment
agreements amounting to €7.5 billion as of December 31, 2025 (€11.2 billion as of December 31, 2024).
Sanofi entered into one major agreement in 2025, as described below:
•in April 2025, Sanofi entered into a license and collaboration agreement with Earendil Labs for two bispecific antibodies in the
field of autoimmune and inflammatory bowel diseases: HXN-1002 (targeting α4β7 and TL1A for potential treatment of
moderate to severe ulcerative colitis and Crohn's disease) and HXN-1003 (targeting TL1A and IL23 for potential treatment of
colitis and skin inflammation). Under the terms of the agreement, Earendil Labs received an upfront payment of $125.0 million,
and is eligible to receive (i) up to $1.7 billion in development and commercial milestone payments and (ii) tiered royalties on
product sales.
In addition, by acquiring all of the outstanding shares of Blueprint in July 2025 and Vigil in August 2025 (see Note D.1.), Sanofi
assumed commitments amounting to €1,606 million and €208 million, respectively, made by those companies to various partners
under collaboration agreements previously entered into.
The amount reported for commitments as of December 31, 2025 also includes commitments under agreements entered into by
Sanofi in prior years. The main such agreements are described below; for a full description of each agreement, refer to the Annual
Report on Form 20-F for the year in which the agreement was entered into.
The major agreements entered into by Sanofi in 2024 are described below:
•Co-exclusive licensing agreement with Novavax. The terms of the agreement include (i) a co-exclusive license to co-
commercialize Novavax’s current stand-alone adjuvanted COVID-19 vaccine worldwide (except in countries with existing
Advance Purchase Agreements and in India, Japan, and South Korea, where Novavax has existing partnership agreements);
(ii) a sole license to Novavax’s adjuvanted COVID-19 vaccine for use in combination with Sanofi’s flu vaccines; and (iii) a non-
exclusive license to use the Matrix-M adjuvant in vaccine products. Novavax received an upfront payment of $500 million and
could receive up to $700 million contingent on attainment of development, regulatory and commercialization milestones,
representing up to $1.2 billion in total. Starting in 2025, Sanofi recognizes sales of Novavax’s adjuvanted COVID-19 vaccine and
bears certain R&D, regulatory and commercialization expenses. Novavax will receive double-digit tiered royalties on Sanofi
sales of COVID-19 vaccines and combined influenza/COVID-19 vaccines. Novavax is also entitled to additional launch and sales
milestone payments of up to $200 million, plus single-digit royalties for each additional Sanofi vaccine product developed
under a non-exclusive license using Novavax’s Matrix-M adjuvant technology. In addition, Sanofi took a minority equity interest
of less than 5% in Novavax. Outside of the collaboration, each party may develop and commercialize their own flu and
COVID-19 vaccines and their own adjuvanted products at their own cost.
•Exclusive licensing agreement with RadioMedix, Inc. and Orano Med for AlphaMedix (SAR447873), a late-stage project
currently being evaluated for the treatment of adult patients with unresectable or metastatic progressive somatostatin-
receptor expressing neuroendocrine tumors (NETs), a rare cancer. Under the licensing agreement, Sanofi will be responsible
for the global commercialization of AlphaMedix, while Orano Med will be responsible for the manufacturing of AlphaMedix
through its global industrial platform currently under development. Under the terms of the agreement, RadioMedix and Orano
Med received an upfront payment of €100 million and could receive up to €220 million based on sales milestones, as well as
being eligible for tiered sales-based royalties.
•Exclusive licensing agreement with CORXEL Pharmaceuticals (CORXEL) to develop and commercialize aficamten in China,
Hong Kong, Macao and Taiwan for the treatment of patients with obstructive and non-obstructive hypertrophic
cardiomyopathy (HCM). Aficamten is an investigational, next-in-class selective small molecule cardiac myosin inhibitor
discovered and developed globally by Cytokinetics. Sanofi has acquired CORXEL’s rights relating to aficamten in China, Hong
Kong, Macao and Taiwan for an undisclosed amount. Cytokinetics remains eligible to receive up to $150 million in development
and commercial milestone payments from Sanofi as well as royalties in the low-to-high teens on future sales of aficamten in
China, Hong Kong, Macao and Taiwan. Cytokinetics is now also eligible to receive additional undisclosed payments in
connection with the execution of the agreement between Sanofi and CORXEL.
F-82 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
The principal agreements entered into by Sanofi in earlier years are listed below:
•Scribe Therapeutics (2022/2023): expanded collaboration and an exclusive license agreement on CasX-Editor(XE) genome
editing technology associated with guide RNAs for multiple targets including sickle cell disease and other genomic diseases;
•Teva Pharmaceuticals (2023): collaboration agreement to co-develop and co-commercialize TEV’574 (duvakitug), for which
positive Phase 2b clinical study results in patients with ulcerative colitis and Crohn’s disease were announced on December 17,
2024;
•Exscientia (2022): an innovative license agreement and research collaboration to develop up to 15 novel small molecule
candidates across oncology and immunology, leveraging Exscientia’s end-to-end AI-driven platform utilizing actual patient
samples;
•ABL Bio (2022): a licensing and collaboration agreement for the development of ABL301, a bispecific antibody intended as a
treatment for alpha-synucleinopathies;
•Adagene Inc., a company specializing in the discovery and development of antibody-based therapies (2022): collaboration
and exclusive license agreement;
•Atomwise (2022): a collaboration agreement that will leverage Atomwise's ATOMNET platform to identify and synthesize up to
•Insilico Medicine (2022): a strategic research collaboration to leverage Insilico Medicine’s AI platform, Pharma.AI, to advance
drug development candidates for up to six new therapeutic targets;
•Innate Pharma SA (2022): an expanded collaboration, with Sanofi licensing a natural killer (NK) cell engager program targeting
B7-H3 from Innate’s ANKET (Antibody-based NK Cell Engager Therapeutics) platform;
•Kymera (2020): agreement to develop and commercialize protein degrader therapies targeting IRAK4 in patients with
immune-inflammatory diseases;
•Nurix Therapeutics (2020): collaboration to develop novel targeted protein degradation therapies; and
•Denali Therapeutics Inc. (2018): collaboration agreement on the development of multiple molecules with the potential to treat
a range of systemic inflammatory diseases such as ulcerative colitis.
Sanofi did not discontinue any collaboration agreement that would have resulted in a significant reduction in commitments as of
December 31, 2025.
In addition, under the collaboration agreement with Regeneron on monoclonal antibodies (see Note C.1.), Sanofi is entitled to
receive an additional share of quarterly profits (capped at 10 % of Regeneron’s share of quarterly profits until March 31, 2022, and
thereafter at 20 %), until Regeneron has paid 50 % of the cumulative development costs incurred by the parties to the alliance.
As of December 31, 2025 this represented total commitments received of €0.5 billion (versus €1.6 billion as of December 31,
2024), against cumulative development costs of €9.0 billion.
Sanofi entered into an agreement with Royalty Pharma in December 2014 relating to development programs, under which
Royalty Pharma bore a portion of the remaining development costs of the project on a quarterly basis in return for royalties on
future sales. The products in development under that agreement have been launched in territories including the US and Europe,
marking the end of the joint development programs.
On February 27, 2017, Sanofi and Lonza announced a strategic partnership in the form of a joint venture (BioAtrium AG) to build
and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland. An initial
investment of approximately €0.3 billion to finance construction of the facility, split 50 /50 between the two partners, has now
been made in full. In addition, Sanofi could pay BioAtrium AG in the region of €0.8 billion over the 2026-2031 period as its share
of operating expenses and the cost of producing future batches.
In February 2014, pursuant to the “Pandemic Influenza Preparedness Framework for the sharing of influenza viruses and access to
vaccines and other benefits” (still effective as of December 31, 2025), Sanofi and the World Health Organization (WHO) signed a
bilateral “Standard Material Transfer Agreement” (SMTA 2). This agreement stipulates that Sanofi will, during declared pandemic
periods, (i) donate 7.5 % of its real-time production of pandemic vaccines against any strain with potential to cause a pandemic,
and (ii) reserve a further 7.5 % of such production on affordable terms. The agreement cancels and replaces all preceding
commitments to donate pandemic vaccines to the WHO.
SANOFI FORM 20-F 2025 | F-83 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
In 2024, Sanofi entered into power purchase agreements in furtherance of its sustainability strategy.
The characteristics of the principal power purchase agreements in place as of December 31, 2025 are summarized below:
Country | Type of energy | Annual volume | Start date | Term | Type of contract | Accounting treatment |
France | Solar | 8 GWh | 2025 | 20 years | PPA(a) | Own use procurement contract(b) |
Wind | 46 GWh | 2025 | 20 years | |||
Wind | 29 GWh | 2025 | 20 years | |||
Wind | 21 GWh | 2025 | 20 years | |||
Wind | 32 GWh | 2025 | 20 years | |||
Wind | 22 GWh | 2025 | 20 years | |||
Solar | 6 GWh | 2025 | 20 years | |||
Solar | 6 GWh | 2025 | 20 years | |||
Solar | 7 GWh | 2025 | 20 years | |||
Wind | 21 GWh | 2025 | 15 years | |||
Wind | 40 GWh | 2025 | 15 years | |||
Germany | Wind | 70 GWh | 2025 | 18 years | ||
Belgium | Wind | 20 GWh | 2026 | 15 years |
(a)PPA (Power Purchase Agreement): long-term renewable energy contract resulting in physical supply of electricity at a predetermined fixed price for the
entire duration of the contract.
(b)At the current stage of analysis with reference to IFRS 10 (Consolidated Financial Statements), IFRS 16 (Leases) and IFRS 9 (Financial Instruments),
Sanofi has concluded that it can apply the own use exception as permitted by paragraph 2.4 of IFRS 9.
These contracts help secure the objective of 100% electricity from renewable sources across all Sanofi operations by 2030.
As of December 31, 2025, Sanofi has not entered into any material new long-term renewable energy contract agreements as part
of its sustainability strategy.
D.21.2. Off balance sheet commitments relating to financing activities
Credit facilities
December 31, 2025 | Expiry | ||||
(€ million) | Total | Less than 1 year | 1 to 3 years | 3 to 5 years | More than 5 years |
General-purpose credit facilities | |||||
As of December 31, 2025, total credit facilities amounted to €8,000 million (versus €8,000 million as of December 31, 2024
and €8,000 million as of December 31, 2023).
Guarantees
(€ million) | 2025 | 2024 | 2023 |
Guarantees given: | |||
•Guarantees provided to banks in connection with credit facilities | |||
•Other guarantees given | |||
Guarantees received | ( | ( | ( |
D.21.3. Off balance sheet commitments relating to asset acquisitions and divestments, and to
changes in the scope of consolidation
On December 24, 2025, Sanofi announced that it had entered into an agreement with Dynavax Technologies Corporation.
(Dynavax), a publicly traded vaccines company. Under the terms of the merger agreement, Sanofi will commence a cash tender
offer to acquire all outstanding shares of Dynavax for $15.50 per share, reflecting a total equity value of approximately $2.2 billion.
See Note D.1.1.6.
As of December 31, 2025, Sanofi had received commitments amounting in aggregate to €0.4 billion in respect of (i) divestments
of assets relating to transactions not yet finalized as of that date and (ii) contingent consideration arising under past agreements.
Off balance sheet commitments of a financing nature with associates and joint ventures are disclosed in Note D.6.
F-84 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
Off balance sheet commitments relating to securities classified in the categories “Equity instruments at fair value through other
comprehensive income” and “Unquoted debt securities not meeting the definition of equity instruments” are respectively
disclosed in Notes D.7.1. and D.7.3..
The maximum amount of contingent consideration relating to business combinations in accordance with IFRS3 is disclosed in
Note D.18.
D.22. Legal and arbitral proceedings
Sanofi and its affiliates are involved in litigation, arbitration and other legal proceedings. These proceedings typically are related
to product liability claims, intellectual property rights (particularly claims against generic companies seeking to limit the patent
protection of Sanofi products), competition law and trade practices, commercial claims, employment and wrongful discharge
claims, tax assessment claims, waste disposal and pollution claims, and claims under warranties or indemnification arrangements
relating to business divestitures. Provisions related to legal and arbitral proceedings are recorded in accordance with the
principles described in Note B.12.
Most of the issues raised by these claims are highly complex and subject to substantial uncertainties; therefore, the probability of
loss and an estimation of damages are difficult to ascertain. Contingent liabilities are cases for which either we are unable to
make a reasonable estimate of the expected financial effect that will result from ultimate resolution of the proceeding, or a cash
outflow is not probable. In either case, a brief description of the nature of the contingent liability is disclosed and, where
practicable, an estimate of its financial effect, an indication of the uncertainties relating to the amount and timing of any outflow,
and the possibility of any reimbursement are provided in application of paragraph 86 of IAS 37.
In the cases that have been settled or adjudicated, or where quantifiable fines and penalties have been assessed, we have
indicated our losses or the amount of provision accrued that is the estimate of the probable loss.
In a limited number of ongoing cases, while we are able to make a reasonable estimate of the expected loss or range of the
possible loss and have accrued a provision for such loss, we believe that publication of this information on a case-by-case basis or
by class would seriously prejudice the Company’s position in the ongoing legal proceedings or in any related settlement
discussions. Accordingly, in those cases, we have disclosed information with respect to the nature of the contingency but have
not disclosed our estimate of the range of potential loss, in accordance with paragraph 92 of IAS 37.
These assessments can involve a series of complex judgments about future events and can rely heavily on estimates and
assumptions. Our assessments are based on estimates and assumptions that have been deemed reasonable by management. We
believe that the aggregate provisions recorded for the above matters are adequate based upon currently available information.
However, given the inherent uncertainties related to these cases and involved in estimating contingent liabilities, we could in the
future incur judgments that could have a material adverse effect on our net income in any particular period.
Long-term provisions are disclosed in Note D.19. They include:
•provisions for product liability risks, litigation and other amount to €1,127 million in 2025. These provisions are mainly related to
product liabilities, government investigations, competition law, regulatory claims, warranties in connection with certain
contingent liabilities arising from business divestitures other than environmental matters and other claims;
•provisions for environmental risks and remediation amount to €493 million in 2025, the majority of which are related to
contingencies that have arisen from business divestitures.
a) Products
Sanofi Pasteur Hepatitis B Vaccine Product Litigation
Since 1996, more than 180 lawsuits have been filed in various French civil courts against Sanofi Pasteur (a French subsidiary of
Sanofi) and/or Sanofi Pasteur MSD SNC (a now terminated joint venture company with Merck & Co. Inc.), for which past ongoing
litigation is now managed by the originating party. In such lawsuits, the plaintiffs allege that they suffer from a variety of
neurological disorders and autoimmune diseases, including multiple sclerosis and Guillain-Barré syndrome, as a result of receiving
the hepatitis B vaccine.
In January 2018, the Appeal Court of Bordeaux found a causal link between the hepatitis B vaccine and multiple sclerosis. In July
2019, the French Supreme Court (Cour de cassation) canceled the judgment of the Appeal Court of Bordeaux and referred
the case back to the Appeal Court of Toulouse. On March 30, 2022, the Appeal Court of Toulouse dismissed all the plaintiffs'
claims.
As of December 31, 2025, there was one ongoing lawsuit related to Sanofi's hepatitis B vaccine.
SANOFI FORM 20-F 2025 | F-85 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
Taxotere Product Litigation in the US
Thousands of lawsuits have been filed against affiliates of Sanofi under US state law for personal injuries allegedly sustained in
connection with the use of Taxotere. The actions have been held in several jurisdictions around the country. In 2021, there were
Sanofi's favor. Throughout 2024, Sanofi entered into a number of settlement agreements or agreements in principle with many
plaintiffs’ firms encompassing nearly all the remaining cases. These agreements were mostly completed over the course of 2025
as they required the consent of the individual plaintiffs which has taken some time to conclude. Sanofi is near the end of the
settlement process and expects approximately 250 plaintiffs to opt out of the settlement and for litigation to continue.
It is not possible, at this stage, to assess with certainty the outcome of these ongoing lawsuits.
Zantac Litigation in the US
In September 2019, the US Food and Drug Administration (FDA) announced it was investigating the claims of an online
pharmacy’s Citizen Petition that the medication Zantac (the brand name for ranitidine) used for stomach heartburn contains or
can generate the chemical N-Nitrosodimethylamine (NDMA), an alleged human carcinogen. As a precautionary measure, Sanofi
initiated a voluntary recall of branded over-the-counter Zantac in October 2019. Concurrent with the FDA investigation, multiple
personal injury lawsuits and class actions alleging that Zantac causes various cancers and seeking damages for either alleged
personal injuries or alleged economic injuries were filed.
Federal court cases were coordinated into a Multi-District Litigation (MDL) in the Southern District of Florida in February 2020.
On December 6, 2022, the MDL Court granted Sanofi and other defendants’ Daubert motions to exclude plaintiff's experts and
summary judgment motions. As a result, the Court entered final judgment in all cases involving plaintiffs’ five designated cancers
and dismissed the class action cases. The MDL Court subsequently dismissed all pending cases alleging a non-designated cancer
for failure to serve expert reports. Approximately 7,900 plaintiffs with cases against Sanofi have filed notices to appeal the
Daubert ruling in the Eleventh Circuit. The Eleventh Circuit held oral argument for the appeal in the fourth quarter of 2025 and a
decision is expected in the second quarter of 2026.
The majority of the state court plaintiffs have cases pending in Delaware, where a hearing on defendants’ Daubert motions to
exclude plaintiffs’ experts took place in January 2024. In May 2024, the State of Delaware court decided not to exclude plaintiffs’
experts from the cases. Sanofi appealed this decision to the Delaware Supreme Court, which granted review. In April 2025, Sanofi
reached several settlement agreements that in total resolve a majority of the Delaware State Court consolidated litigation.
On July 10, 2025, the Delaware Supreme Court unanimously reversed the Superior Court’s (Delaware State Court) denial of
defendants’ Daubert motion based on the lack of reliability of plaintiff’s experts on causation and remanded its findings back to
the Superior Court for proceedings consistent with the rulings in the opinion. On December 1, 2025, the Delaware Superior Court
denied plaintiff’s request to have a rehearing on Daubert grounds and ordered that summary judgment briefing conclude in the
first quarter of 2026 to determine if the remaining cases will be dismissed.
To date, there have been ten trials against other defendants, but none against Sanofi as yet.
In March 2024, Sanofi reached agreement in principle with a number of plaintiffs’ lawyers to resolve Zantac personal injury cases
pending against it in all US state courts outside of Delaware. This agreement would resolve the majority of the cases outside of
Delaware and the MDL.
Overall, as of December 31, 2025, there were around 18,765 remaining individual product liability “plaintiffs” who have all filed
against Sanofi and who are not part of any settlements. The vast majority of these plaintiffs are in either the MDL or Delaware.
Additional cases may be filed.
In addition, in November 2019, Sanofi received a Civil Investigative Demand (CID) related to this issue from the Arizona Attorney
General. Sanofi provided responses in December 2019 and July 2020 and has not received any follow-up requests.
In June 2020, the New Mexico Attorney General filed a complaint against Sanofi for alleged violations of the New Mexico Unfair
Practices Act, violations of the New Mexico False Advertising Act, violations of the New Mexico Public Nuisance Statute, common
law public nuisance, and negligence. This matter was settled in 2025 and is now concluded.
In June 2020, Sanofi received a notice from the US Department of Justice Civil Division and US Attorney’s Office for the Eastern
District of Pennsylvania of an investigation into allegations that pharmaceutical manufacturers violated the False Claims
Act, 31 U.S.C. § 3729, in relation to the drug Zantac and ranitidine hydrochloride through alleged failure to disclose to the federal
government information about the potential presence of NDMA. In response to the notice, Sanofi provided information and
documents including applications and communications with FDA, in August 2020. Sanofi has not received any subsequent
requests from the federal government.
In November 2020, the City Council of Baltimore filed a complaint against Sanofi for alleged violations of the Maryland Consumer
Protection statute, public nuisance, and negligence. This matter was settled in 2025 and is now concluded.
It is not possible, at this stage, to assess with certainty the outcome of the ongoing lawsuits.
F-86 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
Zantac Litigation in Canada
Between 2019 and 2022, seven proposed class actions naming some or all of Sanofi Consumer Health Inc., Sanofi-Aventis Canada
Inc., Chattem (Canada) Inc., Sanofi and Sanofi Pasteur Limited as Defendants, relating to ranitidine were filed in courts in various
Canadian provinces. The cases allege that proposed class members suffered personal injury from the ingestion of ranitidine, and
seek damages in unspecified amounts, disgorgement of profits, restitution in the amount of the purchase price of Zantac and
subrogated damages on behalf of provincial health insurers for health care costs related to ranitidine use.
Between 2021 and 2025, a total of 124 individual claims naming Sanofi Consumer Health Inc., Sanofi-Aventis Canada Inc., Sanofi
Pasteur Limited and Chattem (Canada) Inc. were filed in Ontario and British Columbia.
In May 2023, in the proceedings pending before the Supreme Court of British Columbia, the court dismissed the action, ruling
that there is no scientific support for the plaintiffs' claims. The Superior Court of Quebec has stayed the corresponding proposed
Zantac class proceedings in Quebec until the result of the US Multi-District Litigation (MDL) appeal is announced.
It is not possible, at this stage, to assess with certainty the outcome of the remaining lawsuits.
Talc Product Litigation in the US
Over the last few years, Sanofi affiliates have been named in product liability actions in the US regarding the alleged presence of
asbestos in talc products originating from past acquisitions. A certain number of these claims were also dismissed during that
time. As of December 31, 2025, there were approximately 1,200 ongoing product liability actions. To date, no cases have
proceeded to trial.
It is not possible, at this stage, to assess with certainty the outcome of these ongoing lawsuits.
Depakine Product Litigation in France
Civil proceedings
As of December 31, 2025, 82 families had brought a civil claim involving 136 people exposed in utero to sodium valproate against
a French affiliate of Sanofi seeking indemnification under French law for personal injuries allegedly suffered by children in
connection with the use of sodium valproate (Depakine) by their mothers during pregnancy to treat their epilepsy. These actions
are being held in several jurisdictions in France.
which in November 2019 issued a ruling sending the case before the Paris Appeal Court to rule on Sanofi’s argument on the
compliance of the product with mandatory regulations, as well as on the question of defectiveness of the product and the
assessment of damages. This proceeding is currently pending.
declared the judicial expert report null and void and the Court dismissed one claim in another case.
Concerning five other cases relating to births that occurred between 2005 and 2009, the Court held, on the basis of a non-fault
liability, that Sanofi was liable in light of the wording of the patient information leaflet. Provisional compensation amounts were
set in the range of €0.1 million to €0.5 million in three cases. In the other two cases, expert proceedings have been ordered to
assess the damages.
All the judgments have been appealed and are still pending.
In the class action lawsuit filed in May 2017 by the APESAC (Association des Parents d’Enfants souffrant du Syndrome de l’Anti-
Convulsivant) against the French affiliate, the Judicial Tribunal of Paris ruled on January 5, 2022 that a class is admissible,
retaining Sanofi’s liability between 1984 and January 2006 for malformations and between 2001 and January 2006 for
neuro-developmental disorders (NDD). This decision is based on the conclusions of a criminal expert report within the frame of
ongoing criminal proceedings, for which the Chambre de l’Instruction of the Appeal Court of Paris had ordered a counter-
expertise (see below). The APESAC, Sanofi and its insurers appealed the Judicial Tribunal of Paris’ ruling related to the class
action. This proceeding is currently pending and a stay of proceedings has been ordered awaiting a ruling from the European
Court of Justice (ECJ) (see below).
On July 21, 2021, the Judicial Tribunal of Créteil dismissed a claim for damages brought against Sanofi regarding a child born
in 1995. The Judicial Tribunal considered that the risk of occurrence of NDD in children born to a mother exposed to sodium
valproate during pregnancy was not demonstrated by the state of scientific knowledge at the time of her pregnancy. This
decision was appealed and the proceeding is now pending before the Appeal Court of Paris, which had ordered a stay in the
proceeding until the end of the criminal investigation.
Several questions on the Product Liability Directive have been referred to the ECJ, which will have an impact on the pending
Depakine cases. A ruling from the ECJ is expected during the first quarter of 2026.
Since July 2020, several collective claims have been filed before the Nanterre civil court against the French affiliate representing
at December 2025 approximately 369 claimants including 136 people exposed in utero, seeking indemnification for a prejudice of
anxiety. Part of these claims are currently before the Versailles Court of Appeal on arguments on admissibility and a stay in the
proceedings has been ordered on part of the claims pending the awaited ECJ ruling.
SANOFI FORM 20-F 2025 | F-87 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
Criminal investigation
A criminal investigation was initiated in May 2015 before the Paris Civil Court. In January 2020, the French affiliate of Sanofi was
indicted for aggravated deception and involuntary injuries and in July 2020 for involuntary manslaughter. In July 2020, a judicial
supervision of the affiliate was ordered, together with the implementation of financial guarantees. In November 2020, the Health
Authority (ANSM) was similarly indicted for involuntary injuries and involuntary manslaughters.
On March 9, 2022, the Chambre de l’Instruction of the Appeal Court of Paris (Cour d’appel) ruled that certain complaints for
involuntary manslaughter and several others for aggravated deception and involuntary injuries were time-barred. This decision
was confirmed by the Chambre Criminelle of the French Supreme Court (Cour de cassation) in June 2023. In September 2022,
the investigating judges appointed two experts for a counter-expertise following the Chambre de l’Instruction’s ruling handed
down end of 2021. The counter-expertise report was delivered in 2023. Since 2022, several individual medical assessments have
been ordered by the investigating judge.
Public compensation scheme
In 2017, the French government set up a public compensation scheme to indemnify patients for damages suffered in connection
with the prescription of sodium valproate and its derivatives. The scheme was further amended through the 2020 Finance Law,
with notably the introduction of presumptions of failure to inform the mother since 1982 for malformations and since 1984 for
NDD. The scheme was amended again through the 2021 Finance Law in order to increase the maximum premium applicable in
the event of refusal to make an offer (or making an insufficient offer) where this would be deemed unjustified by a court ruling.
The committee of the compensation scheme has issued several final opinions holding the French affiliate liable for damages
either in full or in part along with the French State, and, in some cases, healthcare practitioners. The French affiliate disagreed
with the committee’s conclusions and has accordingly not offered indemnification to the claimants who have received
compensation from the ONIAM (Office National d’Indemnisation des Accidents Médicaux). The ONIAM is now seeking
reimbursement from Sanofi, which has filed legal actions to oppose ONIAM’s payment orders.
Administrative Actions
In July 2020, March and June 2021, the Montreuil Administrative Court held the French State liable in five administrative
proceedings initiated by families against the State. In March 2021, the Administrative Court did not find any failure to inform the
mother regarding the risk of neurodevelopmental disorders for births in 1999 and in 2002, based on the state of scientific
knowledge at the time. However, regarding the risk of malformations, liabilities were retained against the State, the healthcare
professionals and Sanofi, notably for discrepancy between the SmPC (Summary of the Product Characteristics) and the patient
leaflet. In other cases involving births in 2005-2008, the State was held liable both for malformations and neurodevelopmental
disorders but partially exonerated, taking into account the roles of healthcare practitioners and Sanofi. Given that the French
affiliate was not a party to these administrative proceedings, its arguments (including several requests from the French affiliate to
the Health Authorities to reinforce warnings to healthcare professionals and patients in relation to Depakine) were not
considered.
All rulings were appealed by the claimants. Sanofi has filed requests for voluntary intervention in some of these proceedings to
present its arguments before the Administrative Court of Appeal, which has been granted for some of them. In one proceeding,
the claimants decided to withdraw their claims. In January 2025, the Paris Administrative Court of Appeal handed down five
rulings. In cases concerning births in 2006 onwards, the Court retained the State’s liability and no fault from Sanofi due to the
reiterated variation requests of the medicine’s information documents. In a case concerning births in 1999 and 2002, the Court
retained the State’s liability with a 50% liability retained for Sanofi.
In February 2025, the Versailles Administrative Court of Appeal, in a proceeding concerning births subsequent to 2006, held the
State liable and no fault by Sanofi due to reiterated requests for alterations of the medicine’s information documents.
It is not possible, at this stage, to make a reliable assessment of the outcome of these cases.
Depakine Product Litigation in other EU countries, in the UK and Switzerland
In Switzerland, eleven families have filed a civil claim for damages concerning seventeen people exposed in utero to sodium
valproate. Some of them also involve the claimants’ physicians. In November 2022, one action was declared time-barred by the
judge. The claimant appealed this court decision on the merits. In November 2024, the court confirmed the first instance
judgment. The claimant appealed against this court decision to the Federal Tribunal (last instance).
In Spain, there are seven ongoing actions relating to fourteen people. In March 2022, in one trial, the Court ordered Sanofi to
indemnify four patients. Sanofi appealed this decision. In January 2023, in another trial filed by one patient, the Court of Appeal
confirmed the first instance's decision and dismissed the claim. As of January 2026, one claim is pending in front of the Supreme
Court, another one has been dismissed by the Court of Appeal (but could still be appealed before the Supreme Court) and five
are at the first instance stage.
In Belgium, there are two civil proceedings (currently on hold). A criminal action was discontinued by the Court of Appeal in
September 2025.
In Ireland, there are two cases in Pre-Action stage, two civil claims and one non-statutory public inquiry ongoing.
In the United Kingdom, there is one case in the Pre-Action stage in Great Britain and one civil claim ongoing in Northern Ireland.
It is not possible, at this stage, to assess reliably the outcome of these ongoing cases.
F-88 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
Dengvaxia (Philippines)
From early 2018 up to present date, several claims have been filed in the Philippines by parents of deceased children whose
deaths were allegedly due to vaccination with Dengvaxia. In early March 2019 and in 2020 and 2022, the Philippine Department
of Justice (DOJ) prosecution panel announced it had found probable cause to indict several Sanofi employees/former employees
and former Government officials for “reckless imprudence” resulting in homicides. Since then, several criminal actions have been
filed in court as a result of this finding and are pending at various stages of the legal procedure. Petitions for Review to the DOJ
Secretary have been filed and the said petitions remain pending. Meanwhile, the majority of the respondents have challenged the
jurisdiction of the lower court where the first eight cases had been assigned and this issue was filed with the Supreme Court.
There are several claims that have not yet been filed in any court despite resolutions by the DOJ that there is probable cause.
In July 2024, the Court dismissed the first eight criminal cases, ruling the prosecution failed to establish the elements of “reckless
imprudence” resulting in homicide. The DOJ has resolved there is probable cause to proceed on the remaining cases but no case
has been filed in court to date. In 2025, four additional criminal cases were filed and remain pending with the DOJ.
b) Patents
Praluent (alirocumab)-related Amgen Patent Litigation in the US
In 2014, Amgen Inc. (Amgen) filed four separate complaints against Sanofi and Regeneron in the US District Court for the District
of Delaware (“District Court”) asserting patent infringement relating to Sanofi and Regeneron’s Praluent product. Together these
complaints alleged that Praluent infringed seven patents for antibodies targeting PCSK9 and sought injunctive relief and
unspecified damages.
In February 2021, the Federal Circuit affirmed the District Court’s ruling invalidating the Amgen asserted patent claims.
In November 2021, Amgen filed a petition with the US Supreme Court, asking it to overturn the Federal Circuit decision.
On November 4, 2022, the US Supreme Court granted Amgen’s petition for review. In May 2023, the Supreme Court issued a
unanimous decision in favor of Sanofi and Regeneron regarding the patent infringement actions filed in 2014 by Amgen relating
to Sanofi and Regeneron’s Praluent product. Sanofi and Regeneron received legal costs from Amgen in an amount of $932,000.
As of March 2025, these matters are now closed.
Praluent (alirocumab)-related Amgen Patent Litigation in Europe
In June 2023, Amgen filed an action for infringement of EP 3 666 797 against Sanofi and Regeneron concerning Praluent in the
Munich Local Division of the Unified Patent Court (UPC). Amgen seeks a permanent injunction and unspecified damages and
compensation from March 31, 2023. In June 2023, Sanofi filed a revocation action attacking the validity of EP 3 666 797 in the
Munich Central Division of the UPC. In this action, a first instance decision invalidating this Amgen patent was issued in July 2024.
Amgen appealed, and this decision was reversed by the UPC Court of Appeal in November 2025. A request for rehearing of this
UPC appeal has been filed by Sanofi and Regeneron. A hearing in Amgen’s action for infringement (first instance) in the Munich
Local Division of the UPC will take place in November 2026.
Sanofi and Regeneron have also attacked the validity of the same EP 3 666 797 patent at the European Patent Office (EPO). The
first instance decision of the EPO found Amgen’s patent valid in May 2025. These proceedings are currently under appeal with a
decision expected in April 2026.
c) Other litigation
Plavix (clopidogrel) – Attorney General Action in Hawaii
In March 2014, the Hawaii Attorney General (AG) filed a complaint that sets forth allegations related to the sale and marketing of
and variability of response to Plavix. The Hawaii AG specifically alleged that Plavix had a diminished effect in patients of certain
genetic backgrounds and that Sanofi and BMS had failed to make an earlier disclosure of this information.
In February 2021, the Court issued its decision, imposing penalties in the total amount of $834 million against both Sanofi and
Bristol Myers Squibb (BMS), with $417 million being apportioned to each company. In June 2021, Sanofi and BMS appealed this
judgment. The appeal was transferred directly to the Hawaii Supreme Court. In March 2023, the Hawaii Supreme Court vacated
the judgment and ordered a new trial. A second trial was concluded in October 2023 and in 2024 a judgment was rendered
against the defendants for $916 million ($458 million against Sanofi). Sanofi and BMS have appealed this decision to the Hawaii
Supreme Court. In May 2025, the parties agreed to settle the Hawaii action. Sanofi US paid $350 million pursuant to its settlement
agreement and Bristol-Myers Squibb paid $350 million pursuant to its separate settlement agreement. The appeal and the
underlying case were dismissed pursuant to the settlement. This matter is closed.
Plavix (clopidogrel) – Attorney General Action in Texas
On November 20, 2025, the Texas Attorney General (Texas AG) filed a complaint in Harrison County, Texas, against Sanofi and its
partner Bristol Myers Squibb (BMS). The suit alleges that Defendants failed to warn that Plavix has diminished or no effect for
certain patients, including those who have a genetic variation of a liver enzyme called CYP2C19 which is more prevalent among
minority patients. The lawsuit asserts that Defendants violated the Texas Deceptive Trade Practices Act and Texas’ Health Care
Program Fraud Prevention Act.
Plaintiffs seek civil penalties as well as recovery of claimed Texas Medicaid overpayments for Plavix. Sanofi and BMS are
responsible for the suit on a 50/50 basis under their partnership agreement. In addition, also on November 20, 2025, Sanofi and
BMS sued the Texas AG in Travis County, Texas, arguing that the Texas AG’s lawsuit violated their constitutional due process
SANOFI FORM 20-F 2025 | F-89 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
rights. This suit seeks a declaratory judgment that the Texas AG’s case is unlawful and to enjoin the Texas AG suit from
proceeding.
Plavix (clopidogrel)-related litigation in France
On September 24, 2025, the Paris Court of Appeal ordered Sanofi to pay the CNAM approximately €150 million in damages to
compensate for harm caused by its communication and promotional practices during five months between the end of 2009 and
early 2010, inhibiting the entry on the market of generics of its anticoagulant Plavix. In November 2025, Sanofi filed an appeal
before the French Supreme Court (Cour de cassation).
340B Drug Pricing Program in the United States
Sanofi is currently involved in several matters relating to the 340B drug pricing program in the US (a federal program that
requires drug manufacturers to offer certain products to certain “covered entities” at reduced prices). In 2021, Sanofi launched an
integrity initiative to combat fraud and abuse in the 340B program relating to covered entities’ use of unlimited contract
pharmacies. Under that initiative, Sanofi collects limited, de-identified, claims data on 340B-priced drugs dispensed by contract
pharmacies. In January 2023, the Third Circuit Federal Court of Appeals held that Sanofi’s 340B integrity initiative is not contrary
to law.
In 2024, Sanofi announced that it intended to implement an additional integrity initiative called the “Credit” or “Rebate” Model
whereby credits are provided to covered entities for the difference between the 340B price and initial price paid. When the US
Health Resources and Services Administration (HRSA) rejected Sanofi’s Credit Model, Sanofi filed suit. In May 2025, the court
ruled that the US government had not provided a sufficient explanation for rejecting Sanofi’s Credit Model and ordered HRSA to
conduct a further review, which is ongoing. The court also held that, although Section 340B does not categorically prohibit the
use of manufacturer rebates, it does allow HRSA to require preapproval of a manufacturer rebate program.
Eli Lilly, Bristol Myers Squibb, Novartis, and Kalderos appealed the court’s decision and oral arguments in those appeals, along
with a similar appeal by Johnson & Johnson, were held on November 17, 2025. The appeals are awaiting a ruling.
HRSA has also proposed a 340B Rebate Model Pilot Program, a program that would replace upfront 340B Program discounts
with retrospective rebates for select drugs. A federal district court preliminarily enjoined the 340B Rebate Model Pilot Program
and the First Circuit Court of Appeals has declined to stay that injunction.
ADR Proceedings in the United States
Sanofi is named in two (2) Active 340B Administrative Dispute Resolution (ADR) proceedings, one filed by University of
Washington/Harborview Medical Center in 2023 and one filed by Hudson Headwaters Health Network in 2024, both alleging that
Sanofi’s 340B Integrity Initiative caused “overcharges” under Section 340B. Sanofi previously responded to both filings and in
January 2026, separate 340B ADR Panels were assigned to review the two claims.
State Litigation in the United States
PhRMA and certain other manufacturers are challenging contract pharmacy laws passed by several states, including Arkansas,
Colorado, Hawaii, Kansas, Louisiana, Maine, Maryland, Minnesota, Mississippi, Missouri, Nebraska, New Mexico, North Dakota,
Oklahoma, Oregon, Rhode Island, Tennessee, Utah, South Dakota, West Virginia and Vermont. To date, these state laws have
largely survived these legal challenges, but most of the court rulings are currently under appeal.
Mosaic Health in the United States
In July 2021, Mosaic Health Inc. and Central Virginia Health Services (covered entities) filed a nationwide antitrust class action
complaint against Sanofi and three other manufacturers in the United States District Court for the Western District of New York.
Plaintiffs allege that Sanofi and the other defendants conspired to eliminate favorable 340B pricing, particularly with respect to
diabetes therapies. On September 2, 2022, the court granted Defendants’ motion to dismiss the complaint. On October 3, 2022,
plaintiffs filed a motion for leave to file a second amended complaint, which the court denied on February 1, 2024. Plaintiffs filed
an appeal and in August 2025, the Second Circuit Court of Appeal reversed and ordered the case remanded to the District Court.
Adventist Health System/West in the United States
In June 2023, Adventist Health System/West sued several drug manufacturing companies, including Sanofi-Aventis US LLC,
Sanofi US Services Inc. and Genzyme Corporation, alleging that the companies violated state and federal False Claims Acts
through overcharging for 340B Program drugs in violation of federal “penny pricing” policy. The manufacturers jointly moved to
dismiss, which was granted by the court in March 2024. Plaintiffs filed an appeal.
Antitrust investigation by the European Commission in France and Germany
On September 29, 2025, Sanofi, Sanofi Pasteur Europe and Sanofi Aventis Deutschland were the target of an investigation by
representatives of the European Commission (EC) who visited the premises of Sanofi in France and Germany in connection with
the seasonal flu vaccine space. The EC has subsequently provided Sanofi with a copy of the complaint filed by CSL Sequirus,
which gave rise to the investigation. CSL Sequirus alleges that Sanofi is guilty of disparagement of its Fluad product in certain
markets (primarily Germany) where Sanofi would hold a dominant position. The complaint requests interim measures to be
imposed against Sanofi.
F-90 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
Preliminary investigation by the Parquet national financier in France
Sanofi used a financing arrangement offered by Société Générale as part of an acquisition transaction which happened more
than 10 years ago. This financing arrangement is now under investigation by the French National Financial Prosecutor’s Office
(Parquet national financier - PNF). On November 25, 2025, Sanofi’s headquarters were visited by the authorities as part of this
investigation. The PNF is conducting a preliminary investigation related to allegations of money laundering, tax fraud and criminal
conspiracy.
d) Contingencies arising from certain mergers & acquisitions transactions
As a result of divestitures, Sanofi is subject to a number of ongoing contractual and legal obligations regarding the state of the
sold businesses, their assets, and their liabilities, some of which may be subject to dispute.
Aventis CropScience Retained Liabilities
The sale by Aventis Agriculture SA and Hoechst GmbH (both legacy companies of Sanofi) of their aggregate 76 % participation in
Aventis CropScience Holding (ACS) to Bayer and Bayer CropScience AG (BCS), the wholly owned subsidiary of Bayer which holds
the ACS shares, was effective on June 3, 2002. The Stock Purchase Agreement (SPA) dated October 2, 2001, contained
customary representations and warranties with respect to the sold business, as well as a number of indemnifications subject to
limitation periods and caps, in particular with respect to environmental liabilities for which some outstanding claims from Bayer
remain unresolved.
Infraserv Hoechst Retained Liabilities
By the Asset Contribution Agreement dated December 19/20, 1996, as amended in 1997, Hoechst contributed all land, buildings,
and related assets of the Hoechst site at Frankfurt Hoechst to Infraserv GmbH & Co. Hoechst KG. Infraserv Hoechst undertook to
indemnify Hoechst against environmental liabilities at the Hoechst site and with respect to certain landfills. As consideration for
the indemnification undertaking, Hoechst transferred to Infraserv Hoechst approximately €57 million to fund reserves. In 1997,
Hoechst also agreed it would reimburse current and future Infraserv Hoechst environmental expenses up to €143 million. As a
former operator of the land and as a former user of the landfills, Hoechst may ultimately be liable for costs of remedial action in
excess of this amount.
D.23. Provisions for discounts, rebates and sales returns
Adjustments between gross sales and net sales, as described in Note B.13., are recognized either as provisions or as reductions in
accounts receivable, depending on their nature.
(€ million) | Government and State programs(a) | Managed care and GPO programs(b) | Chargeback incentives | Rebates and discounts | Sales returns | Other deductions | Total | |
Balance at January 1, 2023 | ||||||||
Changes in scope of consolidation | ( | ( | ( | ( | ||||
Provision related to current period sales | ||||||||
Net change in provision related to prior period sales | ( | ( | ( | ( | ( | ( | ||
Payments made | ( | ( | ( | ( | ( | ( | ( | |
Currency translation differences | ( | ( | ( | ( | ( | ( | ( | |
Balance at December 31, 2023 | (c) | |||||||
Provision related to current period sales | ||||||||
Net change in provision related to prior period sales | ( | ( | ( | ( | ( | ( | ||
Payments made | ( | ( | ( | ( | ( | ( | ( | |
Currency translation differences | ( | |||||||
Opella reclassification(d) | ( | ( | ( | ( | ( | ( | ||
Balance at December 31, 2024 | (c) | |||||||
Changes in scope of consolidation | ||||||||
Provision related to current period sales | ||||||||
Net change in provision related to prior period sales | ( | ( | ( | ( | ( | ( | ||
Payments made | ( | ( | ( | ( | ( | ( | ( | |
Currency translation differences | ( | ( | ( | ( | ( | ( | ( | |
Balance at December 31, 2025 | (c) |
€722 million in 2024 and €1,099 million in 2023).
2024 and €1,028 million in 2023).
SANOFI FORM 20-F 2025 | F-91 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
of December 31, 2023.
D.24. Personnel costs
(€ million) | 2025 | 2024 | 2023 |
Salaries | |||
Social security charges (including defined-contribution pension plans) | |||
Other employee benefits(a) | |||
Total(b) |
The total number of registered employees was 76,493 as of December 31, 2025, compared with 84,587 as of December 31, 2024
and 87,994 as of December 31, 2023.
D.25. Other operating income
Other operating income totaled €1,231 million in 2025, versus €1,089 million in 2024 and €979 million in 2023.
Other operating income includes (i) gains from asset divestments, amounting to €485 million in 2025 (versus €539 million in 2024
and €484 million in 2023); (ii) out-licensing income from Amvuttra®, amounting to €475 million in 2025 (versus €186 million in
2024 and €102 million in 2023); and (iii) income from Sanofi’s pharmaceutical partners, amounting to €189 million in 2025
(including €149 million from Regeneron, see Note D.26. below and Note C.1.), compared with €221 million in 2024 (including €166
million from Regeneron), and €285 million in 2023.
2023 comparative figures were re-presented on a consistent basis from the date of the classification of Opella as a discontinued
operation (2024).
D.26. Other operating expenses
Other operating expenses totaled €5,655 million in 2025, compared with €4,382 million in 2024 and €3,443 million in 2023.
2023 comparative figures were re-presented on a consistent basis from the date of the classification of Opella as a discontinued
operation (2024).
and €3,206 million for 2023 (as shown in the table below):
(€ million) | 2025 | 2024 | 2023 |
Income & expense related to sharing of (profits)/losses under the Monoclonal Antibody Alliance | ( | ( | ( |
Additional share of profit paid by Regeneron towards development costs(a) | |||
Reimbursement to Regeneron of selling expenses incurred | ( | ( | ( |
Total - Monoclonal Antibody Alliance | ( | ( | ( |
Other (mainly Zaltrap and Libtayo) | |||
Other operating income/(expenses), net related to Regeneron | ( | ( | ( |
of which amount presented in Other operating income (Note D.25.) |
costs amounted to €0.5 billion, compared with €1.6 billion as of December 31, 2024 (see Note D.21.).
This line item also includes expenses relating to Sanofi’s pharmaceutical partners, amounting to €336 million in 2025 (versus €192
million in 2024 and €20 million in 2023).
Charges to provisions for litigation and environmental risks are also recorded within this line item.
F-92 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
D.27. Restructuring costs and similar items
were comprised of the following items:
(€ million) | 2025 | 2024 | 2023 (a) |
Employee-related expenses | |||
Charges, gains or losses on assets(b) | |||
Costs related to transformation programs | |||
Other(c) | |||
Total |
losses on divestments of assets arising from reorganization decisions made by Sanofi.
mainly related to the Blueprint Medicines acquisition (see Note D.1.).
Restructuring costs and similar items were €258 million lower in 2025 than 2024. In 2024, restructuring and similar costs
mainly comprised the impacts of (i) the renewal of the Job Management and Career Paths (GEPP) program in France to cover the
2024-2026 period, including scope extensions in the job profiles affected by transformations and (ii) a voluntary redundancy
program announced in 2024 in connection with the reorganization of R&D operations to make Sanofi a leader in immunology.
D.28. Other gains and losses, and litigation
Other gains and losses, and litigation for 2025 represented a charge of €255 million related to major litigation.
For 2024, this line item represented a charge of €470 million mainly comprising a provision recognized in respect of the litigation
related to Plavix (clopidogrel) in the US state of Hawaii.
For 2023, this line item represented a charge of €196 million related to major litigation.
2023 comparative figures were re-presented on a consistent basis from the date of the classification of Opella as a discontinued
operation (2024).
D.29. Financial expenses and income
(€ million) | 2025 | 2024 | 2023 | (a) | |
Cost of debt(b) | ( | ( | ( | ||
Interest income(c) | |||||
Cost of net debt | ( | ( | ( | ||
Non-operating foreign exchange gains/(losses) | ( | ||||
Unwinding of discounting of provisions(d) | ( | ( | ( | ||
Net interest cost related to employee benefits | ( | ( | ( | ||
Gains/(losses) on disposals of financial assets | ( | ( | |||
Net interest expense on lease liabilities | ( | ( | ( | ||
Other(e) | ( | ( | |||
Net financial income/(expenses) | ( | ( | ( | ||
comprising: Financial expenses | ( | ( | ( | ||
Financial income |
2023.
2024, €(13 ) million in 2023.
sales in the US. In 2024, the financial expense amounted to €(291 ) million and €(541 ) million in 2023, reflecting the successful launch of Beyfortus (see
Note C.2.).
SANOFI FORM 20-F 2025 | F-93 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
Sanofi has elected for tax consolidations in a number of countries, principally France, Germany, the United Kingdom and the US.
(€ million) | 2025 | 2024 | 2023 (a) |
Current taxes | ( | ( | ( |
Deferred taxes | |||
Total | ( | ( | ( |
Income before tax and investments accounted for using the equity method |
follows:
(%) | 2025 | 2024 | 2023 (a) |
Standard tax rate applicable in France | |||
Difference between the standard French tax rate and the rates applicable to Sanofi(b) | ( | ( | ( |
Revisions to tax exposures and settlements of tax disputes | |||
Fair value remeasurement of contingent consideration | ( | ||
Other items(c) | ( | ||
Effective tax rate |
countries, most of which have lower tax rates than France. This line includes a tax expense of €40 million for the year ended December 31, 2025, and of
€58 million for year ended December 31, 2024, representing the estimated impact of Pillar Two; the 2025 figure also includes a non-recurring tax impact
of €178 million for the temporary exceptional surcharge under the 2025 French Finance Act.
(c)In 2025, the ''Other items'' line includes changes in provisions against deferred tax assets, partially offset by (i) the impact of changes to tax rates in
Germany and the US and the net tax effect of taxable temporary differences associated with holdings in Sanofi subsidiaries. In determining the amount
For the periods presented, the amount of deferred tax assets recognized in profit or loss that were initially subject to impairment
losses at the time of a business combination is immaterial.
The line item Share of profit/(loss) from investments accounted for using the equity method showed a net loss of €155 million
in 2025, including a loss of €310 million on the equity-accounted investment in the associate OPAL JV Co (see Note D.6),
compared with a net gain of €60 million for 2024 and a net loss of €136 million for 2023.
2023 comparative figures were re-presented on a consistent basis from the date of the classification of Opella as a discontinued
operation (2024).
(€ million) | 2025 | 2024 | 2023 |
Share of net income attributable to non-controlling interests | |||
Total |
The principal related parties are companies over which Sanofi has control or significant influence, joint ventures and key
management personnel.
Sanofi has not entered into any material transactions with any key management personnel.
Note F.1. lists the principal companies controlled by Sanofi; those companies are fully consolidated, as described in Note B.1.
Transactions between those companies, and between the parent company and its subsidiaries, are eliminated when preparing
the consolidated financial statements.
Transactions with companies over which Sanofi has significant influence, and with joint ventures, are presented in Note D.6.
Key management personnel include corporate officers and the members of the Executive Committee (an average of 12
in 2025, 13 in 2024 and 10 in 2023).
F-94 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
(€ million) | 2025 | 2024 | 2023 |
Short-term benefits(a) | |||
Post-employment benefits | |||
Share-based payment | |||
Total recognized in profit or loss |
obligations).
held executive positions within Sanofi during that period.
(€ million) | 2025 | 2024 | 2023 |
Aggregate top-up pension obligation in favor of certain corporate officers and of Executive Committee members | |||
Aggregate termination benefits and lump-sum retirement benefits in favor of key management personnel |
D.34.1. Analysis of net sales
(€ million) | Europe | United States | Other countries | 2025 | Europe | United States | Other countries | 2024 | Europe | United States | Other countries | 2023(a) | |
Total Group | |||||||||||||
Immunology | |||||||||||||
of which | Dupixent | ||||||||||||
Rare diseases | |||||||||||||
of which | ALTUVIIIO | ||||||||||||
Nexviazyme | |||||||||||||
Cablivi | |||||||||||||
Xenpozyme | |||||||||||||
Neurology | |||||||||||||
of which | Aubagio | ||||||||||||
Oncology | |||||||||||||
of which | Sarclisa | ||||||||||||
Other medicines | |||||||||||||
of which | Rezurock | ||||||||||||
Tzield | |||||||||||||
Industrial sales | |||||||||||||
Vaccines | |||||||||||||
of which | COVID-19 and Influenza vaccines | ||||||||||||
Polio/Pertussis/ Hib Vaccines | |||||||||||||
RSV vaccines (Beyfortus) | |||||||||||||
Meningitis, travel and endemics vaccines | |||||||||||||
Of which total launches | |||||||||||||
SANOFI FORM 20-F 2025 | F-95 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
D.34.2. Other revenues
(€ million) | 2025 | 2024 | 2023(a) |
VaxServe sales of non-Sanofi products | |||
COVID-19 vaccine related revenues | |||
Sales to Opella(b) | |||
Royalties | |||
Other(c) | |||
Total Biopharma – Other revenues | |||
Sales/revenues from Opella products(d) | |||
Total Other revenues |
within the scope of discontinued operations (see Note D.1). With effect from May 1, 2025, Opella entities are treated as related parties in accordance
with IAS 24 (see Note D.6.).
in China, the transfer of which will be finalized no earlier than 2028; (ii) sales made by the dedicated entity Opella Russie, of which Sanofi continues to
hold the capital (Sanofi is continuing to distribute Opella products in Russian territory under a distribution agreement signed in connection with the
separation, the parties reserving the right to discuss the transfer of that entity during the term of the distribution agreement); and (iii) sales of the Gold
Bond product range, which are continuing in the US through the retained subsidiary Gold Bond LLC (holder of the associated worldwide property
rights).
The segment information presented by Sanofi consists of a single operating segment: Biopharma.
The Biopharma operating segment comprises commercial operations and research, development and production activities
relating to the Specialty Care, General Medicines, and Vaccines franchises plus support and corporate functions, for all
geographical territories. It also includes revenues generated from the manufacture of Consumer Healthcare products invoiced to
Opella Healthcare SAS (Opella), which constitutes a related party with effect from April 30, 2025, the deconsolidation date,
corresponding to the closing of Sanofi's sale of a controlling stake of approximately 50% in Opella to Clayton, Dubilier & Rice
(CD&R) (for more information, see “Item 4. Information on the Company — B. Business overview — B.3 Opella”). Those revenues,
which before the deconsolidation date represented intragroup transactions classified within continuing operations, are
presented within Other revenues in the income statement. The Biopharma operating segment also includes the purchase price
of Biopharma products manufactured by Opella.
The “Other” category comprises primarily, but not exclusively, Consumer Healthcare activities not transferred on the effective
date of loss of control of Opella. These are primarily (i) hospital sales of Opella products in China, the transfer of which will be
finalized no earlier than 2028; (ii) sales made by the dedicated entity Opella Russie, of which Sanofi continues to hold the capital
(Sanofi is continuing to distribute Opella products in Russian territory under a distribution agreement signed in connection with
the separation, the parties reserving the right to discuss the transfer of that entity during the term of the distribution agreement);
and (iii) sales of the Gold Bond product range, which are continuing in the US through the retained subsidiary Gold Bond LLC
(holder of the associated worldwide property rights).
2023 comparative figures were re-presented on a consistent basis from the date of the classification of Opella as a discontinued
operation (2024).
D.35.1. Segment results
Sanofi reports segment results on the basis of “Business operating income”. This indicator is used internally by Sanofi’s chief
operating decision maker to measure the performance of the operating segment and to allocate resources.
“Business operating income” is derived from Operating income, adjusted as follows:
•amortization and impairment losses charged against intangible assets (other than software and other rights of an industrial or
operational nature), are eliminated;
•fair value remeasurements of contingent consideration relating to business combinations (IFRS 3) or business divestments,
and presented within the line item Fair value remeasurement of contingent consideration, are eliminated;
•expenses arising from the remeasurement of inventories following business combinations (IFRS 3) or acquisitions of groups of
assets that do not constitute a business within the meaning of paragraph 2b of IFRS 3, are eliminated;
•amounts reported within the line items Restructuring costs and similar items are eliminated;
•other gains and losses including gains and losses on major divestments, presented within the line item Other gains and losses,
and litigation, are eliminated;
•other costs and provisions related to litigation, presented within the line item Other gains and losses, and litigation, are
eliminated;
F-96 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
•the share of profits/losses from investments accounted for using the equity method is added, to the extent that this relates
(i) to joint ventures or (ii) to associates with which Sanofi has entered into R&D agreements and/or whose operations are
managed as an integral part of Sanofi’s business activities;
•the portion of business operating income net of tax attributable to non-controlling interests is deducted; and
•net income attributable to non-controlling interests related to continuing operations, and excluding the effects of the above
reconciliation items, is deducted.
2023:
2025 | |||||||||
(€ million) | Biopharma | Other | Total | ||||||
2025 | Change vs. 2024 on a reported basis (IFRS) | Change vs. 2024 at constant exchange rates (non- IFRS) | 2025 | Change vs. 2024 on a reported basis (IFRS) | Change vs. 2024 at constant exchange rates (non- IFRS) | 2025 | Change vs. 2024 on a reported basis (IFRS) | Change vs. 2024 at constant exchange rates (non- IFRS) | |
Net sales | +6.2% | +9.9% | +6.2% | +9.9% | |||||
Other revenues | -9.2% | -5.8% | +43.7% | +43.4% | -3.6% | -0.6% | |||
Cost of sales | ( | -2.4% | +0.5% | ( | +20.3% | +18.9% | ( | -2.1% | +0.8% |
Research and development expenses | ( | +6.0% | +8.8% | ( | +100.0% | +100.0% | ( | +6.1% | +8.8% |
Selling and general expenses | ( | +2.8% | +6.1% | ( | +148.6% | +152.9% | ( | +3.9% | +7.3% |
Other operating income and expenses | ( | ( | ( | ||||||
Share of profit/(loss) from investments accounted for using the equity method | |||||||||
Net income attributable to non-controlling interests | ( | ( | |||||||
Business operating income | +7.4% | +12.3% | -55.2% | -63.8% | +7.1% | +11.9% | |||
As % of net sales | 27.8% | 27.8% | |||||||
2024 | |||
(€ million) | Biopharma | Other | Total |
Net sales | |||
Other revenues | |||
Cost of sales | ( | ( | ( |
Research and development expenses | ( | ( | ( |
Selling and general expenses | ( | ( | ( |
Other operating income and expenses | ( | ( | |
Share of profit/(loss) from investments accounted for using the equity method | |||
Net income attributable to non-controlling interests | ( | ( | |
Business operating income | |||
2023(a) | |||
(€ million) | Biopharma | Other | Total |
Net sales | |||
Other revenues | |||
Cost of sales | ( | ( | ( |
Research and development expenses | ( | ( | ( |
Selling and general expenses | ( | ( | ( |
Other operating income and expenses | ( | ( | |
Share of profit/(loss) from investments accounted for using the equity method | |||
Net income attributable to non-controlling interests | ( | ( | |
Business operating income | |||
SANOFI FORM 20-F 2025 | F-97 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
for the segment and Income before tax and investments accounted for using the equity method:
(€ million) | 2025 | 2024 | 2023(a) |
Business operating income | |||
Share of profit/(loss) from investments accounted for using the equity method(b) | ( | ( | ( |
Net income attributable to non-controlling interests(c) | |||
Amortization of intangible assets | ( | ( | ( |
Impairment of intangible assets(d) | ( | ( | ( |
Fair value remeasurement of contingent consideration | ( | ( | ( |
Expenses arising from the impact of acquisitions on inventories(e) | ( | ( | ( |
Restructuring costs and similar items(f) | ( | ( | ( |
Other gains and losses, and litigation(g) | ( | ( | ( |
Operating income | |||
Financial expenses | ( | ( | ( |
Financial income | |||
Income before tax and investments accounted for using the equity method |
multiple sclerosis, reflecting the reduced probability of approval arising from the negative PERSEUS Phase 3 study results and recent exchanges with the
FDA and EMA. For 2024, this line includes a net impairment charge of €248 million, mainly due to (i) recognition of impairment losses of €640 million
against various research and development projects (including a €239 million loss resulting from the decision taken in February 2025 to discontinue a
Phase 3 clinical study investigating a vaccine candidate to prevent invasive E.coli disease), partially offset by (ii) impairment loss reversals recognized in
connection with the disposals of the ProXTen platform and Enjaymo, for €225 million and €167 million respectively. For 2023, this line mainly comprises
an impairment loss of €833 million, reflecting the impact of the strategic decision to de-prioritize certain R&D programs, in particular those related to
the NK Cell and ProXTen technology platforms.
Blueprint Medicines acquisition (see Note D.1.).
D.35.2. Other segment information
2023 comparative figures were re-presented on a consistent basis from the date of the classification of Opella as a discontinued
operation (2024).
The tables below show the split by operating segment of (i) the carrying amount of investments accounted for using the equity
method related (a) to joint ventures or (b) to associates with which Sanofi has entered into R&D agreements and/or whose
operations are managed as an integral part of Sanofi’s business activities; (ii) acquisitions of property, plant and equipment; and
(iii) acquisitions of intangible assets.
The principal investments accounted for using the equity method in the Biopharma segment are the interests in MSP Vaccine
Company and in Infraserv GmbH & Co. Höchst KG (see Note D.6.).
Biopharma | |||
(€ million) | 2025 | 2024 | 2023 |
Investments accounted for using the equity method(a) | |||
Acquisitions of property, plant and equipment | |||
Acquisitions of other intangible assets | |||
F-98 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
D.35.3. Information by geographical region
Net sales | |||
(€ million) | 2025 | 2024 | 2023(a) |
Europe | |||
of which France | |||
United States | |||
Rest of the World | |||
of which China | |||
Total | |||
In accordance with IFRS 8, the non-current assets reported below exclude financial instruments, deferred tax assets, pre-funded
pension obligations, and right-of-use assets as determined under IFRS 16.
(€ million) | 2025 | 2024 | 2023(a) | |||
Property, plant and equipment | Other intangible assets | Property, plant and equipment | Other intangible assets | Property, plant and equipment | Other intangible assets | |
Europe | ||||||
of which France | ||||||
United States | ||||||
Rest of the World | ||||||
of which China | ||||||
Total | ||||||
As stated in Note D.5., goodwill is not allocated by geographical region.
D.35.4. Disclosures about major customers
Sales generated by Sanofi with its biggest customers, in particular certain wholesalers in the US, represented 36 % of net sales in
2025. The three largest customers respectively accounted for approximately 18 %, 12 % and 6 % of Sanofi's net sales in 2025 (15 %,
SANOFI FORM 20-F 2025 | F-99 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
discontinued operations
On April 30 2025, the Opella transaction was closed (see Note D.1.) triggering loss of control, and resulting in the derecognition of
all assets and liabilities of Opella subsidiaries. As of December 31, 2024, all Opella assets and associated liabilities were classified as
held for sale (see Note D.8.), in accordance with IFRS 5.
(€ million) | December 31, 2024 |
Assets | |
Property, plant and equipment owned | |
Right-of-use assets | |
Goodwill | |
Other intangible assets | |
Inventories | |
Accounts receivable | |
Other assets | |
Total assets held for sale | |
Liabilities | |
Lease liabilities | |
Non-current provisions and other non-current liabilities | |
Accounts payable | |
Current provisions and other current liabilities | |
Other liabilities | |
Total liabilities related to assets held for sale |
In accordance with IFRS 5, the Opella held for sale asset group, and the related liabilities, have been measured at the lower of
carrying amount and fair value less costs to sell. This valuation did not result in the recognition of any impairment.
The table below details the main items presented within Net income from discontinued operations:
(€ million) | 2025 | 2024 | 2023 |
Net sales and other revenues (a) | |||
Operating income (a) | |||
Gain on disposal of Opella before tax | |||
Income before tax and investments accounted for using the equity method | |||
Income tax expense (b) | ( | ( | ( |
Net income from discontinued operations (Opella) |
(b) In 2025, this line includes an expense of €108 million related to the tax impact on the gain arising on the loss of control of Opella (see Note D.1.).
Net income from the Opella discontinued operation was €274 million lower in 2024 than in 2023. This year-on-year change
reflects in particular the acceleration in 2024 of the transformational project to create the standalone Opella entity - transaction
costs incurred in 2024 in respect of the proposed Opella transfer - and changes in gains from asset divestments within the Opella
scope between the two periods.
In addition, net income from the Opella discontinued operation for the year ended December 31, 2024 includes a net tax expense
of €122 million relating to the tax cost of the legal restructuring of the Opella scope. For the year ended December 31, 2023, net
income from the Opella discontinued operation includes a €365 million deferred tax liability recognized in respect of investments
in consolidated entities in light of the proposed separation of the Opella business.
(Earnings per Share):
(€ million) | 2025 | 2024 | 2023 |
Net income from discontinued operations (Opella) | |||
Average number of shares outstanding (million) | |||
Average number of shares after dilution (million) | |||
Basic earnings per share (in euros) | |||
Diluted earnings per share (in euros) |
F-100 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
PricewaterhouseCoopers Audit and Forvis Mazars SA served as independent auditors of Sanofi for the year ended December 31,
2025.
the years ended December 31, 2025 and 2024.
Forvis Mazars | PricewaterhouseCoopers | |||||||
2025 | 2024 | 2025 | 2024 | |||||
(€ million) | Amount | % | Amount | % | Amount | % | Amount | % |
Statutory audit of separate and consolidated financial statements(a) | ||||||||
Limited review of sustainability statement(b) | ||||||||
Services other than statutory audit(c) | ||||||||
Audit-related services(d)(e) | ||||||||
Tax | ||||||||
Other | ||||||||
Total | ||||||||
PricewaterhouseCoopers Audit €11.8 million in 2025, €12.5 million in 2024 and Forvis Mazars €4.8 million in 2024.
- additional procedures to enable reports previously signed by the firm to be incorporated by reference; and
- assurance engagements, agreed-upon procedures and technical consultancy.
Services other than statutory audit provided by PricewaterhouseCoopers during 2025 comprised:
- contractual audits, including on the combined financial statements of the Opella business;
- additional procedures to enable reports previously signed by the firm to be incorporated by reference; and
- assurance engagements, agreed-upon procedures, tax compliance work and technical consultancy.
PricewaterhouseCoopers Audit €4.1 million in 2025, Forvis Mazars €0.1 million in 2024 and PricewaterhouseCoopers Audit €3.5 million in 2024.
(which qualify as audit fees under SEC rules).
SANOFI FORM 20-F 2025 | F-101 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
of consolidation during 2025
F.1. Principal fully consolidated companies
Europe | Financial interest (%) as of December 31, 2025 | |
Hoechst GmbH | Germany | |
Sanofi-Aventis Deutschland GmbH | Germany | |
Sanofi-Aventis GmbH | Austria | |
Sanofi Belgium | Belgium | |
Ablynx NV | Belgium | |
Genzyme Flanders BV | Belgium | |
Sanofi A/S | Denmark | |
Sanofi-Aventis SA | Spain | |
Sanofi Oy | Finland | |
Sanofi | France | |
Sanofi Winthrop Industrie | France | |
Sanofi-Aventis Recherche & Développement | France | |
Sanofi-Aventis Groupe | France | |
Sanofi-Aventis Participations | France | |
Sanofi Pasteur | France | |
Aventis Agriculture | France | |
Sanofi Biotechnology | France | |
Sanofi Pasteur Merieux SAS | France | |
Sanofi-Aventis AEBE | Greece | |
Sanofi-Aventis Private Co Ltd | Hungary | |
Chinoin Private Co Ltd | Hungary | |
Carraig Insurance DAC | Ireland | |
Genzyme Ireland Limited | Ireland | |
Sanofi-Aventis Ireland Ltd | Ireland | |
Sanofi-Aventis Holdings (Ireland) Ltd | Ireland | |
Sanofi SRL | Italy | |
Genzyme Global Sarl | Luxembourg | |
Genzyme Luxembourg Sarl | Luxembourg | |
Le Rock Re | Luxembourg | |
Sanofi-Aventis Norge AS | Norway | |
Blueprint Medicines (Netherlands) B.V. | Netherlands | |
Sanofi BV | Netherlands | |
Sanofi Foreign Participations BV | Netherlands | |
Sanofi Horizon BV | Netherlands | |
Sanofi-Aventis Sp. z o.o. | Poland | |
Sanofi Produtos Farmaceuticos Lda | Portugal | |
Sanofi sro | Czech Republic | |
Sanofi Romania SRL | Romania | |
Sanofi-Aventis UK Holdings Limited | United Kingdom | |
Aventis Pharma Limited | United Kingdom | |
Sanofi-Synthelabo UK Ltd | United Kingdom | |
Aventis Pharma Holdings Ltd | United Kingdom | |
Kymab Limited | United Kingdom | |
AO Sanofi Russia | Russia | |
Opella Healthcare LLC | Russia |
F-102 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
Europe | Financial interest (%) as of December 31, 2025 | |
Sanofi AB | Sweden | |
Sanofi-Aventis (Suisse) SA | Switzerland | |
Genzyme Global Sarl Baar Intellectual Property Branch | Switzerland | |
Sanofi Ilac Sanayi ve Ticaret AS | Turkey | |
Sanofi Pasteur Asi Ticaret AS | Turkey | |
Sanofi Saglik Urunleri Limited Sirketi | Turkey |
United States | Financial interest (%) as of December 31, 2025 | |
Genzyme Therapeutic Products Limited Partnership | United States | |
Aventis Inc. | United States | |
Sanofi US Services Inc. | United States | |
Sanofi-Aventis U.S. LLC | United States | |
Aventisub LLC | United States | |
Genzyme Corporation | United States | |
Sanofi Pasteur Inc. | United States | |
VaxServe, Inc. | United States | |
Bioverativ Inc. | United States | |
Bioverativ U.S. LLC | United States | |
Bioverativ USA Inc. | United States | |
Bioverativ Therapeutics Inc. | United States | |
Blueprint Medicines Corporation | United States | |
Principia Biopharma Inc. | United States | |
Sanofi Ventures LLC | United States | |
Sanofi Bioverativ Holdings LLC | United States | |
Radera | United States | |
RPR US Ltd | United States | |
Kadmon Pharmaceuticals LLC | United States | |
Kadmon Corporation, LLC | United States | |
Provention Bio | United States | |
Gold Bond Co LLC | United States | |
Sanofi AATD, Inc. | United States | |
Translate Bio, Inc. | United States | |
Vigil Neuroscience, Inc. | United States |
SANOFI FORM 20-F 2025 | F-103 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
Other countries | Financial interest (%) as of December 31, 2025 | |
Sanofi-Aventis South Africa (Pty) Ltd | South Africa | |
Sanofi-Aventis Algérie | Algeria | |
Sanofi Arabia Trading Company Limited | Saudi Arabia | |
Sanofi-Aventis Argentina SA | Argentina | |
Sanofi-Aventis Australia Pty Ltd | Australia | |
Sanofi Medley Farmaceutica Ltda | Brazil | |
Sanofi-Aventis Canada Inc. | Canada | |
Sanofi Pasteur Limited | Canada | |
Merieux Canada Holdings ULC (Canada) | Canada | |
Sanofi Vaccines Chile SA | Chile | |
Sanofi (Hangzhou) Pharmaceuticals Co Ltd | China | |
Sanofi (China) Investment Co Ltd | China | |
Sanofi (Beijing) Pharmaceuticals Co Ltd | China | |
Sanofi (Jiangsu) Biologics Co Ltd | China | |
Shenzhen Sanofi pasteur Biological Products Co Ltd | China | |
Shanghai Rongheng Pharmaceutical Co Ltd | China | |
Sanofi-Aventis de Colombia SA | Colombia | |
Sanofi-Aventis Korea Co Ltd | South Korea | |
Sanofi-Aventis Gulf FZE | United Arab Emirates | |
Sanofi Egypt | Egypt | |
Sanofi Hong-Kong Limited | Hong Kong | |
Sanofi India Limited | India | |
Sanofi Healthcare India Private Limited | India | |
Sanofi Israël Ltd | Israel | |
Sanofi KK | Japan | |
Sanofi-Aventis (Malaysia) SDN BHD | Malaysia | |
Sanofi-Aventis Maroc | Morocco | |
Sanofi Pasteur SA de CV | Mexico | |
Azteca Vacunas SA de CV | Mexico | |
Sanofi-Aventis Puerto Rico Inc. | Puerto Rico | |
Sanofi-Aventis Philippines Inc. | Philippines | |
Sanofi-Aventis Singapore Pte Ltd | Singapore | |
Aventis Pharma (Manufacturing) Pte Ltd | Singapore | |
Sanofi Manufacturing Pte Ltd | Singapore | |
Sanofi Taiwan Co Ltd | Taiwan | |
Sanofi-Aventis (Thailand) Ltd | Thailand | |
Sanofi-Aventis de Venezuela SA | Venezuela | |
Sanofi-Aventis Vietnam Company Limited | Vietnam |
F-104 | SANOFI FORM 20-F 2025 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |
F.2.Principal investments accounted for using the equity method
Financial interest (%) as of December 31, 2025 | ||
Infraserv GmbH & Co. Höchst KG | Germany | |
Opal JVCO S.a r.l. | Luxembourg | |
MSP Vaccine Company | United States | |
EUROAPI | France |
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English translation and language consultancy: Stephen Reynolds & Jane Lambert. Photo credits: Front cover: Shuang Yang, Scientist, China ©Jacques Ballard/satellitemylove - p. 93: © Yann Audic - p. 94: © Jean Chiscano - p. 95: © Alain Buu - p. 96: @ Label image , 24 rue Gambetta, 78800 Houilles - p. 98: © GE China - p. 99: © Christel Sasso/Capa Pictures - p. 100: © Lisbeth Holten, Denmark – p. 101: @ Yann Audic - p. 102: Christel Sasso/Capa Pictures - p. 103: © Julien Lutt/Capa Pictures - p. 104: © Julien Mignot - p. 97: © MarieLouiseGaspard - p. 105: © DR - p. 106: © Nan Friedman/PS Studio - p. 107: © Oscar Timmers/Capa Pictures – p. 108: © Jennifer Altman/Capa Pictures. | ||
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FAQ
How much did Sanofi (SNY) spend on R&D in 2025?
Sanofi spent €7,842 million on research and development in 2025, equal to 18.0% of net sales. This reflects a strategic push into immunology, rare diseases, neurology, oncology, and vaccines, aiming to refresh its pipeline as older products face patent expiry and competition.
How important is Dupixent to Sanofi (SNY) according to the 2025 20-F?
Dupixent is Sanofi’s largest product, generating €15,714 million of net sales in 2025, which is 36.0% of total net sales. This heavy reliance means Sanofi’s growth, profitability, and risk profile are closely tied to Dupixent’s competitive position, pricing, and safety record.
What share of Sanofi (SNY) 2025 net sales came from the United States?
The United States accounted for 50.8% of Sanofi’s net sales in 2025. This large US exposure makes the company particularly sensitive to American drug-pricing reforms, including Most Favored Nation arrangements and Inflation Reduction Act Medicare negotiations described in the annual report.
How does US and EU drug pricing policy affect Sanofi (SNY)?
Sanofi reports that US MFN pricing models and the Inflation Reduction Act, along with EU pharmaceutical and HTA reforms, increase pressure on prices and launch strategies. These policies can constrain pricing flexibility, influence global launch sequencing, and potentially weigh on long-term revenue growth.
What major risk categories does Sanofi (SNY) highlight in its 20-F?
Sanofi highlights product liability and regulatory risk, pricing and reimbursement pressure, intellectual property challenges, cyber and data-privacy threats, complex manufacturing and supply chains, climate change, geopolitical instability, and customer credit risk. Each of these could materially affect future sales, margins, and strategic execution.
What accounting standards does Sanofi (SNY) use in its 20-F financial statements?
Sanofi prepares its consolidated financial statements in accordance with IFRS as issued by the IASB and as endorsed by the EU, as of December 31, 2025. This framework governs how it reports assets, liabilities, income, expenses, and key performance metrics to investors.
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