Moderna swings to $162M Q3 profit as revenue rises
A Phase 3 melanoma combination showed a 42% lower recurrence-or-death risk; overall-survival data were not yet mature.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Form Type
10-Q
Rhea-AI Filing Summary
Moderna, Inc. reported third-quarter 2026 total revenue of $1.313 billion, compared with $1.016 billion a year earlier, and net income of $162 million versus a $200 million net loss. For the first nine months, revenue was $1.847 billion and net loss was $1.963 billion; operating cash outflow was $2.715 billion.
In Phase 3 INTerpath-001, intismeran plus KEYTRUDA reduced recurrence-or-death risk by 42% and distant-metastasis-or-death risk by 38% versus KEYTRUDA alone after a median 24.6-month follow-up. Overall-survival data were not yet mature, and the study remains ongoing.
Moderna issued $3.0 billion aggregate principal amount of 0.00% convertible notes due 2032 and received approximately $3.0 billion net proceeds; it paid $329 million for capped calls. It paid $950 million in July under its settlement with Arbutus and Genevant concerning worldwide litigation related to Spikevax and mRESVIA. After appealing the District Court's decision related to 28 U.S.C. § 1498, Moderna could be required to make an additional payment of up to $1.3 billion depending on the appeal outcome. Moderna launched mFLUSIVA in the U.S. in September after FDA approval for adults 50 years of age and older.
3 points · 1 major0 major · 1 point
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Major pointPhase 3 combination reduced recurrence-or-death risk 42% versus KEYTRUDA alone.
- Moderate pointThird-quarter total revenue rose 29% year over year to $1.313 billion.
- Moderate pointThird-quarter net income was $162 million, versus a $200 million net loss.
Negative
- Moderate point. Forward-looking: it has not happened yet and may not happen.Appeal outcome could require an additional payment of up to $1.3 billion. 1.3% of market cap
Key Figures
Total revenue: $1.313 billion
Total revenue change: 29%
Net income: $162 million
+5 more
8 metrics
Total revenue
$1.313 billion
Three months ended September 30, 2026
Total revenue change
29%
Three months ended September 30, 2026 versus 2025
Net income
$162 million
Three months ended September 30, 2026; net loss of $200 million in the 2025 period
Net loss
$1.963 billion
Nine months ended September 30, 2026
Net cash used in operating activities
$2.715 billion
Nine months ended September 30, 2026
Convertible notes principal
$3.0 billion
0.00% Convertible Senior Notes due 2032
Recurrence-or-death risk reduction
42%
Intismeran plus KEYTRUDA versus KEYTRUDA alone; median follow-up of 24.6 months
Distant-metastasis-or-death risk reduction
38%
Intismeran plus KEYTRUDA versus KEYTRUDA alone; median follow-up of 24.6 months
Key Terms
recurrence-free survival (RFS), distant metastasis-free survival (DMFS), Capped Call Transactions, conversion rate, +1 more
5 terms
recurrence-free survival (RFS) medical
"met its primary endpoint of recurrence-free survival (RFS)"
distant metastasis-free survival (DMFS) medical
"a key secondary endpoint of distant metastasis-free survival (DMFS)"
Capped Call Transactions financial
"Capped Call Transactions are call options on our common stock"
Capped call transactions are agreements where investors buy options that give them the chance to benefit if a stock's price goes up, but with a limit on how much they can gain. This helps protect them from paying too much if the stock's price rises a lot, similar to having a maximum limit on a reward. They matter because they help investors manage risk while still allowing some upside potential.
conversion rate financial
"The initial conversion rate is 4.7487 shares"
Conversion rate is the proportion of items, people or contracts that take a desired action out of the total possible — for example the share of website visitors who make a purchase, or the number of convertible bonds that are exchanged for shares. Investors care because it measures how effectively a business or financial instrument turns opportunity into real outcomes, like sales or share issuance, which directly affects revenue, cash flow and ownership dilution.
deferred revenue financial
"deferred revenue of $218 million related to product sales"
Cash a company has already received for goods or services it has promised but not yet delivered; it's recorded as a liability because the company still owes that product, service, or future revenue recognition. For investors, deferred revenue signals upcoming work or deliveries that will convert into reported sales over time and affects short-term obligations, cash flow quality, and how quickly a firm can grow recognized revenue—think of it like prepaid subscriptions or gift cards a business must honor later.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were MRNA's Q3 2026 results?
Moderna reported $1.313 billion in total revenue for the three months ended September 30, 2026, compared with $1.016 billion in the same 2025 period. Net income was $162 million, compared with a net loss of $200 million.
What are the terms of MRNA's 2032 convertible notes?
Moderna issued $3.0 billion aggregate principal amount on September 1, 2026. The notes bear no regular interest and mature March 1, 2032. The initial conversion rate is 4.7487 shares per $1,000 principal amount, equivalent to an initial conversion price of approximately $210.58 per share; special interest may accrue in certain circumstances.
How does MRNA plan to use the convertible-note proceeds?
Moderna intends to use the remaining net proceeds for general corporate purposes, which may include investments in the growth of its oncology business and repayment of debt. The company received approximately $3.0 billion in net proceeds from the notes and paid $329 million for capped call transactions.
Could MRNA owe more under its Arbutus and Genevant settlement?
Moderna paid $950 million in July under its settlement with Arbutus and Genevant resolving worldwide litigation related to Spikevax and mRESVIA. After appealing a District Court decision related to 28 U.S.C. § 1498, Moderna could be required to make an additional payment of up to $1.3 billion, depending on the appeal outcome.
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
| FORM | |||||
(Mark One)
For the quarterly period ended September 30, 2026
OR
For the transition period from _ to _
Commission File Number: 001-38753
(Exact Name of Registrant as Specified in Its Charter)
| (State or Other Jurisdiction of Incorporation or Organization) | (IRS Employer Identification No.) | ||||||||||
| (Address of Principal Executive Offices) | (Zip Code) | ||||||||||
(617 ) 714-6500
(Registrant’s Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading symbol(s) | Name of each exchange on which registered | ||||||
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). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company”, and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| ☒ | Accelerated filer o | Non-accelerated filer o | Smaller reporting company | |||||||||||||||||||||||
| Emerging growth company | ||||||||||||||||||||||||||
If an emerging growth company, 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 provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒
As of October 30, 2026, there were 404,620,975 shares of the registrant’s common stock, par value $0.0001 per share, outstanding.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q (Form 10-Q) contains express or implied forward-looking statements. All statements other than those of historical facts contained in this Form 10-Q are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements in this Form 10-Q include, but are not limited to, statements about:
•our ability to drive use of our commercial products and expectations regarding sales growth in 2026;
•our ability to execute on our prioritized research and development portfolio;
•our ability to deliver cost efficiency across our business;
•our expectations regarding the size and durability of the respiratory vaccine market;
•our long-term strategic partnerships with government entities;
•anticipated near-term regulatory actions for our product candidates, including potential filings, reviews and approvals;
•anticipated milestones for our pipeline programs, including potential data readouts and other near-term catalysts;
•our ability to obtain and maintain regulatory approval of our product candidates across our portfolio;
•our ability to successfully launch and commercialize our products and the timing of launches;
•the potential of intismeran and our oncology portfolio more broadly;
•the progress of the clinical development program for intismeran and the potential of intismeran in other tumor types and across settings;
•the favorable trend in overall survival data for intismeran;
•encouraging activity observed in the Phase 1/2 study of mRNA-2808;
•our ability and the ability of third parties with whom we contract to successfully manufacture, supply and distribute our commercial products and any future commercial products at scale, as well as drug substances, delivery vehicles, development candidates, and investigational medicines for preclinical and clinical use;
•financing and funding options we may consider as part of our research and development strategy;
•our ability to successfully contract with third-party suppliers, distributors and manufacturers;
•internal and external costs associated with manufacturing our products and the impact on our cost of sales, and our anticipated cost of sales as a percentage of net product sales;
•the scope of protection we are able to establish and maintain for intellectual property rights, including those covering our commercial products, product candidates and technology, and our expectations regarding pending legal proceedings related to our intellectual property;
•the timing of initiation, progress, completion, results and cost of our clinical trials, preclinical studies and research and development programs, as well as those of our collaborators;
•participant enrollment in our clinical trials, including timing;
•potential advantages of mRNA as compared to traditional medicine;
•the implementation of our business model and strategic plans for our business, products, product candidates and technology;
•the pricing and reimbursement of our products, if approved;
•the build out of our manufacturing and commercial operations;
•estimates of our future expenses, revenues and capital requirements;
•our operation and funding requirements, including our forecast of the period of time through which our financial resources will be adequate to support our operations;
•the potential benefits of strategic collaboration agreements and our ability to enter into strategic collaborations or other agreements with collaborators with development, regulatory and commercialization expertise;
•our financial performance;
•our tax positions and related tax liabilities;
•legal and regulatory developments in the United States and foreign countries;
•the outcome of ongoing legal proceedings;
•our ability to produce our products or product candidates with advantages in turnaround times or manufacturing cost; and
•developments relating to our competitors and our industry.
Forward-looking statements often contain words such as “will,” “may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our operational or financial performance, and involve risks, uncertainties, and other factors that may cause our actual results to differ materially from any future results expressed or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under the section entitled “Risk Factors” and elsewhere in this Form 10-Q and under Part I, Item 1A. “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025. If one or more of these risks or uncertainties occur, or if our underlying assumptions prove to be incorrect, actual results could differ materially from those expressed or implied by the forward-looking statements.
The forward-looking statements in this Form 10-Q represent our views as of the date of this Form 10-Q. We undertake no obligation to update any forward-looking statements, except as required by applicable securities law. You should therefore not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this Form 10-Q. However, any further disclosures made on related subjects in our subsequent reports filed with the Securities and Exchange Commission should be consulted.
TRADEMARKS
This Form 10-Q contains references to our trademarks and to trademarks belonging to other entities. Solely for convenience, trademarks and trade names referred to may appear without the ® or ™ symbols, but such references are not intended to indicate that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend our reference to other companies’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
NOTE REGARDING COMPANY REFERENCES
Unless the context otherwise requires, the terms “Moderna,” the “Company,” “we,” “us” and “our” in this Form 10-Q refer to Moderna, Inc. and its consolidated subsidiaries.
ADDITIONAL INFORMATION
Our website, www.modernatx.com, including the Investor Relations section, www.investors.modernatx.com; and corporate blog www.modernatx.com/moderna-blog, and our Statements and Perspectives webpage, https://investors.modernatx.com/Statements--Perspectives/default.aspx; as well as our social media channels: Facebook, www.facebook.com/modernatx; X, www.x.com/moderna_tx (@moderna_tx); LinkedIn, www.linkedin.com/company/modernatx; Instagram (@moderna_tx); and Threads (@moderna_tx) contain a significant amount of information about us, including financial and other information for investors. We encourage investors to visit these websites and social media channels as information is frequently updated and new information is shared. Information contained on our website, corporate blog and social media channels shall not be deemed incorporated into, or be a part of, this Form 10-Q.
Table of Contents
PART I. | Page | |||||||
| Item 1. | Financial Statements (Unaudited) | 6 | ||||||
Condensed Consolidated Balance Sheets as of September 30, 2026 and December 31, 2025 | 6 | |||||||
Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2026 and 2025 | 7 | |||||||
Condensed Consolidated Statements of Comprehensive Income (Loss) for the three and nine months ended September 30, 2026 and 2025 | 8 | |||||||
Condensed Consolidated Statements of Stockholders' Equity for the three and nine months ended September 30, 2026 and 2025 | 9 | |||||||
Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2026 and 2025 | 11 | |||||||
Notes to Condensed Consolidated Financial Statements | 12 | |||||||
| Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 33 | ||||||
| Item 3. | Quantitative and Qualitative Disclosures about Market Risk | 43 | ||||||
| Item 4. | Controls and Procedures | 43 | ||||||
PART II. | ||||||||
Item 1. | Legal Proceedings | 44 | ||||||
Item 1A. | Risk Factors | 45 | ||||||
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 47 | ||||||
Item 5. | Other Information | 47 | ||||||
| Item 6. | Exhibits | 48 | ||||||
SIGNATURES | 49 | |||||||
Table of Contents
Item 1. Financial Statements
MODERNA, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited, in millions, except per share data)
| September 30, | December 31, | ||||||||||
| 2026 | 2025 | ||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | $ | |||||||||
| Investments | |||||||||||
| Accounts receivable, net | |||||||||||
| Inventory | |||||||||||
| Prepaid expenses and other current assets | |||||||||||
| Total current assets | |||||||||||
| Investments, non-current | |||||||||||
| Property, plant and equipment, net | |||||||||||
| Right-of-use assets, operating leases | |||||||||||
| Other non-current assets | |||||||||||
| Total assets | $ | $ | |||||||||
| Liabilities and Stockholders’ Equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | $ | |||||||||
| Accrued liabilities | |||||||||||
| Deferred revenue | |||||||||||
| Other current liabilities | |||||||||||
| Total current liabilities | |||||||||||
| Deferred revenue, non-current | |||||||||||
| Operating lease liabilities, non-current | |||||||||||
| Financing lease liabilities, non-current | |||||||||||
| Long-term debt | |||||||||||
| Convertible notes | |||||||||||
| Other non-current liabilities | |||||||||||
| Total liabilities | |||||||||||
Commitments and contingencies (Note 12) | |||||||||||
| Stockholders’ equity: | |||||||||||
Preferred stock, par value $ | |||||||||||
Common stock, par value $ | |||||||||||
| Additional paid-in capital | |||||||||||
| Accumulated other comprehensive income | |||||||||||
| Retained earnings | |||||||||||
| Total stockholders’ equity | |||||||||||
| Total liabilities and stockholders’ equity | $ | $ | |||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6
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MODERNA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited, in millions, except per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||||||||||
| Revenue: | ||||||||||||||||||||||||||
| Net product sales | $ | $ | $ | $ | ||||||||||||||||||||||
| Other revenue | ||||||||||||||||||||||||||
| Total revenue | ||||||||||||||||||||||||||
| Operating expenses: | ||||||||||||||||||||||||||
| Cost of sales | ||||||||||||||||||||||||||
| Research and development | ||||||||||||||||||||||||||
| Selling, general and administrative | ||||||||||||||||||||||||||
| Total operating expenses | ||||||||||||||||||||||||||
| Income (loss) from operations | ( | ( | ( | |||||||||||||||||||||||
| Interest income | ||||||||||||||||||||||||||
| Other (expense) income, net | ( | ( | ||||||||||||||||||||||||
| Income (loss) before taxes | ( | ( | ( | |||||||||||||||||||||||
| Provision for income taxes | ||||||||||||||||||||||||||
| Net income (loss) | $ | $ | ( | $ | ( | $ | ( | |||||||||||||||||||
| Earnings (loss) per share | ||||||||||||||||||||||||||
| Basic | $ | $ | ( | $ | ( | $ | ( | |||||||||||||||||||
| Diluted | $ | $ | ( | $ | ( | $ | ( | |||||||||||||||||||
Weighted average common shares used in calculation of earnings (loss) per share | ||||||||||||||||||||||||||
| Basic | ||||||||||||||||||||||||||
| Diluted | ||||||||||||||||||||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
7
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MODERNA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(Unaudited, in millions)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||||||||||
| Net income (loss) | $ | $ | ( | $ | ( | $ | ( | |||||||||||||||||||
| Other comprehensive (loss) income, net of tax: | ||||||||||||||||||||||||||
| Available-for-sale securities: | ||||||||||||||||||||||||||
| Unrealized (losses) gains on available-for-sale securities | ( | ( | ||||||||||||||||||||||||
| Less: net realized gains (losses) on available-for-sale securities reclassified in net income (loss) | ( | |||||||||||||||||||||||||
| Net (decrease) increase from available-for-sale securities | ( | ( | ||||||||||||||||||||||||
| Pension and postretirement obligation adjustments | ||||||||||||||||||||||||||
| (Losses) gains on foreign currency translation | ( | ( | ||||||||||||||||||||||||
| Total other comprehensive (loss) income | ( | ( | ||||||||||||||||||||||||
| Comprehensive income (loss) | $ | $ | ( | $ | ( | $ | ( | |||||||||||||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
8
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MODERNA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
(Unaudited, in millions)
| Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Income | Retained Earnings | Total Stockholders’ Equity | |||||||||||||||||||||||||||||||
| Shares | Amount | ||||||||||||||||||||||||||||||||||
| Balance at June 30, 2026 | $ | $ | $ | $ | $ | ||||||||||||||||||||||||||||||
| Vesting of restricted common stock units | — | — | — | — | — | ||||||||||||||||||||||||||||||
| Exercise of options to purchase common stock | — | — | — | ||||||||||||||||||||||||||||||||
| Tax payments related to net share settlements on equity awards | — | — | ( | — | — | ( | |||||||||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | |||||||||||||||||||||||||||||||
| Purchase of capped calls related to convertible notes | — | — | ( | — | — | ( | |||||||||||||||||||||||||||||
| Other comprehensive loss, net of tax | — | — | — | ( | — | ( | |||||||||||||||||||||||||||||
| Net income | — | — | — | — | |||||||||||||||||||||||||||||||
| Balance at September 30, 2026 | $ | $ | $ | $ | $ | ||||||||||||||||||||||||||||||
| Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Income | Retained Earnings | Total Stockholders’ Equity | |||||||||||||||||||||||||||||||
| Shares | Amount | ||||||||||||||||||||||||||||||||||
| Balance at June 30, 2025 | $ | $ | $ | $ | $ | ||||||||||||||||||||||||||||||
| Vesting of restricted common stock | — | — | — | — | — | ||||||||||||||||||||||||||||||
| Exercise of options to purchase common stock | — | — | — | — | |||||||||||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | |||||||||||||||||||||||||||||||
| Other comprehensive income, net of tax | — | — | — | — | |||||||||||||||||||||||||||||||
| Net loss | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||
| Balance at September 30, 2025 | $ | $ | $ | $ | $ | ||||||||||||||||||||||||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
9
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| Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Income | Retained Earnings | Total Stockholders’ Equity | |||||||||||||||||||||||||||||||
| Shares | Amount | ||||||||||||||||||||||||||||||||||
| Balance at December 31, 2025 | $ | $ | $ | $ | $ | ||||||||||||||||||||||||||||||
| Vesting of restricted common stock | — | — | — | — | — | ||||||||||||||||||||||||||||||
| Exercise of options to purchase common stock | — | — | — | ||||||||||||||||||||||||||||||||
| Tax payments related to net share settlements on equity awards | — | — | ( | — | — | ( | |||||||||||||||||||||||||||||
| Issuance of common stock under employee stock purchase plan | — | — | — | — | |||||||||||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | |||||||||||||||||||||||||||||||
| Purchase of capped calls related to convertible notes | — | — | ( | — | — | ( | |||||||||||||||||||||||||||||
| Other comprehensive loss, net of tax | — | — | ( | — | ( | ||||||||||||||||||||||||||||||
| Net loss | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||
| Balance at September 30, 2026 | $ | $ | $ | $ | $ | ||||||||||||||||||||||||||||||
| Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive (Loss) Income | Retained Earnings | Total Stockholders’ Equity | |||||||||||||||||||||||||||||||
| Shares | Amount | ||||||||||||||||||||||||||||||||||
| Balance at December 31, 2024 | $ | $ | $ | ( | $ | $ | |||||||||||||||||||||||||||||
| Vesting of restricted common stock | — | — | — | — | — | ||||||||||||||||||||||||||||||
| Exercise of options to purchase common stock | — | — | — | — | |||||||||||||||||||||||||||||||
| Tax payments related to net share settlements on equity awards | — | — | ( | — | — | ( | |||||||||||||||||||||||||||||
| Issuance of common stock under employee stock purchase plan | — | — | — | — | |||||||||||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | |||||||||||||||||||||||||||||||
| Other comprehensive income, net of tax | — | — | — | — | |||||||||||||||||||||||||||||||
| Net loss | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||
| Balance at September 30, 2025 | $ | $ | $ | $ | $ | ||||||||||||||||||||||||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
10
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MODERNA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited, in millions)
| Nine Months Ended September 30, | |||||||||||
| 2026 | 2025 | ||||||||||
| Operating activities | |||||||||||
| Net loss | $ | ( | $ | ( | |||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||
| Stock-based compensation | |||||||||||
| Depreciation and amortization | |||||||||||
| Amortization/accretion of investments | ( | ( | |||||||||
| Loss on equity investments, net | |||||||||||
| Other non-cash items | |||||||||||
| Changes in assets and liabilities: | |||||||||||
| Accounts receivable, net | ( | ( | |||||||||
| Prepaid expenses and other assets | ( | ( | |||||||||
| Inventory | ( | ( | |||||||||
| Right-of-use assets, operating leases | |||||||||||
| Accounts payable | ( | ( | |||||||||
| Accrued liabilities | ( | ||||||||||
| Deferred revenue | |||||||||||
| Operating lease liabilities | ( | ( | |||||||||
| Other liabilities | ( | ( | |||||||||
| Net cash used in operating activities | ( | ( | |||||||||
| Investing activities | |||||||||||
| Purchases of marketable securities | ( | ( | |||||||||
| Proceeds from maturities of marketable securities | |||||||||||
| Proceeds from sales of marketable securities | |||||||||||
| Purchases of property, plant and equipment | ( | ( | |||||||||
| Purchase of intangible asset | ( | ( | |||||||||
| Net cash (used in) provided by investing activities | ( | ||||||||||
| Financing activities | |||||||||||
| Proceeds from issuance of convertible notes | |||||||||||
| Payments for issuance costs related to convertible notes | ( | ||||||||||
| Purchase of capped calls related to convertible notes | ( | ||||||||||
| Proceeds from issuance of common stock through equity plans | |||||||||||
| Tax payments related to net share settlements on equity awards | ( | ( | |||||||||
| Changes in financing lease liabilities | ( | ( | |||||||||
| Net cash provided by financing activities | |||||||||||
| Effect of changes in exchange rates on cash and cash equivalents | |||||||||||
| Net decrease in cash, cash equivalents and restricted cash | ( | ( | |||||||||
| Cash, cash equivalents and restricted cash, beginning of year | |||||||||||
| Cash, cash equivalents and restricted cash, end of period | $ | $ | |||||||||
| Non-cash investing and financing activities | |||||||||||
| Purchases of property and equipment included in accounts payable and accrued liabilities | $ | $ | |||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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MODERNA, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
(Unaudited)
1. Description of the Business
Moderna, Inc. (collectively, with its consolidated subsidiaries, any of Moderna, we, us, our or the Company) is a biotechnology company advancing a new class of medicines made of messenger RNA (mRNA). mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that have a therapeutic or preventive benefit with the potential to address a broad spectrum of diseases. Our platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing us the capability to pursue in parallel a robust pipeline of new development candidates.
Since our founding in 2010, we have transformed from a research-stage company advancing programs in the field of mRNA to a commercial enterprise with a diverse clinical portfolio of vaccines and therapeutics across several modalities, a broad intellectual property portfolio and integrated manufacturing capabilities that allow for rapid clinical and commercial production at scale. As of September 30, 2026, we had five approved products—Spikevax® and mNEXSPIKE® , our COVID vaccines; mRESVIA®, our vaccine against respiratory syncytial virus (RSV); our flu plus COVID combination vaccine, which was authorized for individuals 50 years of age and older in Europe (marketed as mCOMBRIAX®) and in Canada (marketed as mCOFLU®); and mFLUSIVA® , our influenza vaccine, which was approved in the United States and Canada for individuals 50 years of age and older.
In addition to our commercial products, we are advancing a diverse pipeline of development candidates across infectious disease vaccines, oncology therapeutics, and rare disease therapeutics. Within our oncology therapeutics modality, we and Merck & Co., Inc. (Merck) are jointly developing intismeran autogene (mRNA-4157) , a novel investigational mRNA-based individualized neoantigen therapy. We and Merck are advancing a robust clinical development program for intismeran, which currently consists of nine total Phase 2 and Phase 3 clinical trials across multiple tumor types and stages of disease.
2. Summary of Basis of Presentation and Recent Accounting Standards
Basis of Presentation and Principles of Consolidation
The accompanying unaudited condensed consolidated financial statements that accompany these notes have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) and applicable rules and regulations of the Securities and Exchange Commission (SEC) for interim financial reporting, consistent in all material respects with those applied in our Annual Report on Form 10-K for the year ended December 31, 2025 (2025 Form 10-K). Any reference in these notes to applicable guidance is meant to refer to the authoritative accounting principles generally accepted in the United States as found in the Accounting Standards Codification (ASC) and Accounting Standards Update (ASU) of the Financial Accounting Standards Board (FASB). This report should be read in conjunction with the audited consolidated financial statements in our 2025 Form 10-K.
Use of Estimates
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Comprehensive Income (Loss)
Comprehensive income (loss) includes net income (loss) and other comprehensive income/loss for the period. Other comprehensive income/loss consists of unrealized gains/losses on our investments, derivatives designated as hedging instruments, foreign currency translation, and pension and postretirement obligation adjustments. Total comprehensive income (loss) for all periods presented has been disclosed in the condensed consolidated statements of comprehensive income (loss).
The components of accumulated other comprehensive income (loss) for the three and nine months ended September 30, 2026 were as follows (in millions):
Unrealized Gains (losses) on Available-for-Sale Debt Securities | Pension and Postretirement Obligation Adjustments | Gains (Losses) on Foreign Currency Translation | Total | ||||||||||||||||||||
| Accumulated other comprehensive income, balance at December 31, 2025 | $ | $ | $ | $ | |||||||||||||||||||
| Other comprehensive loss | ( | ( | ( | ||||||||||||||||||||
| Accumulated other comprehensive income, balance at March 31, 2026 | $ | $ | $ | $ | |||||||||||||||||||
| Other comprehensive loss | ( | ( | ( | ||||||||||||||||||||
| Accumulated other comprehensive income, balance at June 30, 2026 | $ | $ | $ | ( | $ | ||||||||||||||||||
| Other comprehensive loss | ( | ( | |||||||||||||||||||||
| Accumulated other comprehensive income, balance at September 30, 2026 | $ | $ | $ | ( | $ | ||||||||||||||||||
Restricted Cash
The following table provides a reconciliation of cash, cash equivalents and restricted cash in the condensed consolidated balance sheets that sum to the total of the same such amounts shown in the condensed consolidated statements of cash flows (in millions):
| September 30, | ||||||||||||||
| 2026 | 2025 | |||||||||||||
| Cash and cash equivalents | $ | $ | ||||||||||||
Restricted cash(1) | ||||||||||||||
Restricted cash, non-current(2) | ||||||||||||||
Total cash, cash equivalents and restricted cash shown in the condensed consolidated statements of cash flows | $ | $ | ||||||||||||
_______
(1)Included in prepaid expenses and other current assets in the condensed consolidated balance sheets.
(2)Included in other non-current assets in the condensed consolidated balance sheets.
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Recently Issued Accounting Standards
From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by us as of the specified effective date. Except as noted below, we believe that the impact of recently issued standards that are not yet effective will not have a material impact on our condensed consolidated financial statements and disclosures.
In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. This ASU requires entities to disclose, on an annual and interim basis, disaggregated information in the footnotes related to certain expense categories included in income statement line items. Specifically, entities are expected to provide tabular disclosures for prescribed categories such as inventory purchases, employee compensation, depreciation, and intangible asset amortization for each relevant expense caption. The standard also requires disclosure of total selling expenses and a definition of those expenses in annual filings. Any remaining amounts not quantitatively disclosed are expected to be described qualitatively. This ASU is effective for fiscal years beginning after December 15, 2026 and interim periods beginning after December 15, 2027. Early adoption permitted, and the standard may be applied on a prospective or retrospective basis. We are currently assessing the impact that this new accounting standard will have on our consolidated financial statement disclosures.
In September 2025, the FASB issued ASU No. 2025-06, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software. This ASU makes targeted amendments to the accounting for and disclosure of software costs under ASC 350-40. The amendments modernize the guidance to reflect current software development practices, including nonlinear development approaches, and remove references to “development stages.” Under the ASU, the following two criteria must be met for entities to begin capitalizing software costs: (1) management, with the relevant authority, implicitly or explicitly authorizes and commits to funding a computer software project, and (2) it is probable that the project will be completed and the software will be used to perform the function intended (referred to as the “probable-to-complete recognition threshold”). The ASU clarifies that this threshold would not be met when there is “significant uncertainty associated with the development activities of the software (referred to as ‘significant development uncertainty’).” The new standard is effective for all entities for annual reporting periods beginning after December 15, 2027, and for interim reporting periods within those fiscal years. Early adoption is permitted, and entities may apply the amendments prospectively, retrospectively, or using a modified prospective transition approach. We are currently evaluating the impact that this new accounting standard will have on our consolidated financial statements and disclosures.
In September 2025, the FASB issued ASU No. 2025-07, Derivatives and Hedging (Topic 815) and Revenue from Contracts with Customers (Topic 606): Derivatives Scope Refinements and Scope Clarification for Share-Based Noncash Consideration From a Customer in a Revenue Contract. This ASU expands the scope exceptions in the derivatives guidance to exclude certain non-exchange-traded contracts with underlyings based on the operations or activities of one of the parties to the contract, including the occurrence or nonoccurrence of an event specific to those operations or activities. The ASU also clarifies that share-based noncash consideration received from a customer in exchange for goods or services should be accounted for as noncash consideration under ASC 606 unless and until the entity’s right to receive or retain such consideration becomes unconditional. The ASU is effective for annual reporting periods beginning after December 15, 2026, including interim periods within those annual reporting periods. Early adoption is permitted. We early adopted this ASU in the third quarter of 2026, and the adoption did not have a material impact on our condensed consolidated financial statements and disclosures.
In December 2025, the FASB issued ASU No. 2025-10, Government Grants (Topic 832): Accounting for Government Grants Received by Business Entities. This ASU establishes guidance on the recognition, measurement, presentation, and disclosure of government grants received by business entities. The guidance defines a government grant as a transfer of a monetary asset or a tangible nonmonetary asset from a government to a business entity other than in an exchange transaction and excludes transactions within the scope of other U.S. GAAP. Under the ASU, government grants are classified as either grants related to an asset or grants related to income, and recognition is permitted only when it is probable that the entity will comply with the conditions attached to the grant and that the grant will be received. The ASU permits alternative presentation approaches depending on the nature of the grant and requires disclosures regarding the nature of the grant, affected financial statement line items, and significant terms and conditions. The ASU is effective for public business entities for annual reporting periods beginning after December 15, 2028, including interim periods within those annual reporting periods. Early adoption is permitted, and the standard may be applied on a modified prospective, modified retrospective, or full retrospective basis. We are currently evaluating the impact of this new accounting standard and do not expect its adoption to have a material impact on our consolidated financial statements and disclosures.
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3. Net Product Sales
Net product sales by customer geographic location were as follows (in millions):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||||||||||
| United States | $ | $ | $ | $ | ||||||||||||||||||||||
| Europe | ||||||||||||||||||||||||||
| Rest of world | ||||||||||||||||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||||||||||||
Net product sales by product type were as follows (in millions):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||||||||||
COVID(1) | $ | $ | $ | $ | ||||||||||||||||||||||
RSV | ||||||||||||||||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||||||||||||
_______
(1) Includes sales of Spikevax and mNEXSPIKE.
As of September 30, 2026, we have five approved products, our COVID vaccines, Spikevax and mNEXSPIKE, our RSV vaccine, mRESVIA, our flu plus COVID combination vaccine, mCOMBRIAX, and our influenza vaccine, mFLUSIVA. We launched commercial sales of mNEXSPIKE in the third quarter of 2025. In April 2026, mCOMBRIAX was approved by the European Commission for the prevention of influenza disease and COVID-19 in adults 50 years of age and older. As of September 30, 2026, mCOMBRIAX had not been commercialized. In August 2026, mFLUSIVA was approved by the U.S. Food and Drug Administration (FDA) for the prevention of influenza disease in adults 50 years of age and older, and we launched commercial sales of mFLUSIVA in September 2026. Net product sales of mFLUSIVA were immaterial for the quarter, reflecting the timing of the approval and launch relative to the 2026–2027 influenza contracting season, as well as uncertainty regarding uptake of mFLUSIVA during the season.
We sell our vaccines to the commercial market as well as to governments and international organizations. In the U.S., our vaccines are sold primarily to wholesalers and distributors, and to a lesser extent, directly to retailers, healthcare providers and government entities. Wholesalers and distributors typically do not make upfront payments to us. Net product sales are recognized net of estimated chargebacks, fulfillment fees, prompt-pay discounts, provisions for sales returns and government rebates, and other related deductions.
The following table summarizes product sales provision adjustments for the periods presented (in millions):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||||||||||
| Gross product sales | $ | $ | $ | $ | ||||||||||||||||||||||
Product sales provision: | ||||||||||||||||||||||||||
| Chargebacks, discounts and fees | ( | ( | ( | ( | ||||||||||||||||||||||
Returns, rebates and other fees | ( | ( | ( | ( | ||||||||||||||||||||||
Total product sales provision adjustments | $ | ( | $ | ( | $ | ( | $ | ( | ||||||||||||||||||
| Net product sales | $ | $ | $ | $ | ||||||||||||||||||||||
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The following table summarizes the activities related to product sales provision recorded as accrued liabilities for the nine months ended September 30, 2026 (in millions):
Returns and other fees | ||||||||
| Balance at December 31, 2025 | $ | ( | ||||||
Provision related to sales made in current period | ( | |||||||
Provision related to sales made in prior periods | ||||||||
| Payments and returns related to sales made in current period | ||||||||
Payments and returns related to sales made in prior year | ||||||||
| Balance at September 30, 2026 | $ | ( | ||||||
4. Other Revenue
The following table summarizes other revenue for the periods presented (in millions):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||||||||||
Stand-ready manufacturing revenue | $ | $ | $ | $ | ||||||||||||||||||||||
Collaboration revenue (Note 5) | ||||||||||||||||||||||||||
| Grant revenue | ||||||||||||||||||||||||||
Licensing and royalty revenue | ||||||||||||||||||||||||||
| Total other revenue | $ | $ | $ | $ | ||||||||||||||||||||||
5. Collaboration Agreements and Research and Development Funding Arrangement
Merck – Individualized Neoantigen Therapy (Intismeran Autogene)
In June 2016, we entered into a Collaboration and License Agreement, which was subsequently amended in 2018, with Merck for the development and commercialization of individualized neoantigen therapy (INT), which has been assigned the generic name intismeran autogene.
In September 2022, Merck exercised its option for intismeran, including mRNA-4157, pursuant to the terms of the agreement and in October 2022 paid us an option exercise fee of $250 million. Following this exercise, the Merck Participation Term commenced. Pursuant to the agreement, we and Merck have agreed to collaborate on development and potential commercialization of intismeran, with costs and any profits or losses generally shared equally on a worldwide basis, subject to certain exceptions as outlined in the agreement. During the development phase, we are primarily responsible for process development and the manufacture of intismeran materials, while Merck generally leads clinical trials. We concluded that the collaboration arrangement under the Merck Participation Term is within the scope of ASC 808. For the three and nine months ended September 30, 2026, we recognized expenses, net of Merck's reimbursements, of $95 million and $293 million, respectively, related to the INT collaboration under the Merck Participation Term. For the three and nine months ended September 30, 2025, these expenses were $101 million and $304 million, respectively.
Additionally, for the three and nine months ended September 30, 2026, the net cost recovery for capital expenditures was $1 million and $3 million, respectively. For the three and nine months ended September 30, 2025, this amount was $1 million and $19 million, respectively. These amounts were applied to reduce the capitalized cost of the assets.
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Recordati –Propionic Acidemia Therapeutic
In January 2026, we entered into a collaboration agreement with Recordati S.p.A. (Recordati) to advance the development and commercialization of our investigational propionic acidemia therapeutic, mRNA-3927. Under the terms of the agreement, we granted Recordati an exclusive, royalty-bearing license to develop and commercialize the licensed product (mRNA-3927) worldwide, we will perform and continue to lead clinical development activities through approval, and Recordati will lead global commercialization upon approval. The transaction closed on March 16, 2026, and we received a $50 million upfront payment in the second quarter of 2026. The upfront payment is being recognized as collaboration revenue over time. In addition, we are eligible to receive up to $110 million in development and regulatory milestones, as well as additional commercial and sales milestones and tiered royalties on net sales.
We have other collaborative and licensing arrangements that we do not consider to be individually significant to our business at this time. Pursuant to these agreements, we may be required to make upfront payments and payments upon achievement of various development, regulatory and commercial milestones, which in the aggregate could be significant. Future milestone payments, if any, will be reflected in our consolidated financial statements when the corresponding events have occurred. In addition, we may be required to pay significant royalties on future sales if products related to these arrangements are commercialized.
Development and Commercialization Funding Arrangement with Blackstone Life Sciences (Blackstone)
In March 2024, we entered into a development and commercialization funding arrangement with Blackstone, under which Blackstone has committed to providing up to $750 million in funding to us. This funding supports the development of our investigational mRNA-based influenza vaccine. Given the substantive transfer of financial risk to Blackstone, we account for this arrangement as an obligation to conduct research and development activities. The funding is recognized as a reduction to the expenses of our mRNA-based influenza program. This reduction is recognized proportionally as the related costs are incurred, based on an input method. Changes in estimated costs to complete the funded activities may result in cumulative adjustments to the amount of funding recognized in a reporting period. For the three and nine months ended September 30, 2026, we recorded expense reductions of $69 million and $143 million, respectively. For the three and nine months ended September 30, 2025, we recorded research and development expense reductions of $25 million and $274 million, respectively.
Following the first commercial sale of mFLUSIVA in September 2026, Blackstone became entitled to receive low single-digit percentage royalties and up to $750 million in sales milestone payments. These payments are based on net sales of our influenza and combination vaccines, with sales milestone payments contingent upon achieving specified cumulative net sales targets. No royalties or milestone payments were accrued as of September 30, 2026.
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6. Financial Instruments
Cash and Cash Equivalents and Investments
The following tables summarize our cash, cash equivalents, and available-for-sale securities by significant investment category as of September 30, 2026 and December 31, 2025 (in millions):
| September 30, 2026 | ||||||||||||||||||||||||||||||||||||||||||||
| Amortized Cost | Unrealized Gains | Unrealized Losses | Estimated Fair Value | Cash and Cash Equivalents | Current Marketable Securities | Non- Current Marketable Securities | ||||||||||||||||||||||||||||||||||||||
| Cash and cash equivalents | $ | $ | — | $ | — | $ | $ | $ | — | $ | — | |||||||||||||||||||||||||||||||||
| Available-for-sale: | ||||||||||||||||||||||||||||||||||||||||||||
| Certificates of deposit | — | |||||||||||||||||||||||||||||||||||||||||||
| U.S. treasury bills | — | |||||||||||||||||||||||||||||||||||||||||||
| U.S. treasury notes | ( | — | ||||||||||||||||||||||||||||||||||||||||||
| Corporate debt securities | ( | — | ||||||||||||||||||||||||||||||||||||||||||
| Government debt securities | ( | — | ||||||||||||||||||||||||||||||||||||||||||
| Total | $ | $ | $ | ( | $ | $ | $ | $ | ||||||||||||||||||||||||||||||||||||
| December 31, 2025 | ||||||||||||||||||||||||||||||||||||||||||||
| Amortized Cost | Unrealized Gains | Unrealized Losses | Estimated Fair Value | Cash and Cash Equivalents | Current Marketable Securities | Non- Current Marketable Securities | ||||||||||||||||||||||||||||||||||||||
| Cash and cash equivalents | $ | $ | — | $ | — | $ | $ | $ | — | $ | — | |||||||||||||||||||||||||||||||||
| Available-for-sale: | ||||||||||||||||||||||||||||||||||||||||||||
| Certificates of deposit | — | |||||||||||||||||||||||||||||||||||||||||||
| U.S. treasury bills | — | |||||||||||||||||||||||||||||||||||||||||||
| U.S. treasury notes | ( | — | ||||||||||||||||||||||||||||||||||||||||||
| Corporate debt securities | ( | — | ||||||||||||||||||||||||||||||||||||||||||
| Government debt securities | — | |||||||||||||||||||||||||||||||||||||||||||
| Total | $ | $ | $ | ( | $ | $ | $ | $ | ||||||||||||||||||||||||||||||||||||
The amortized cost and estimated fair value of available-for-sale securities by contractual maturity as of September 30, 2026 and December 31, 2025 were as follows (in millions):
| September 30, 2026 | ||||||||||||||
| Amortized Cost | Estimated Fair Value | |||||||||||||
| Due in one year or less | $ | $ | ||||||||||||
| Due after one year through five years | ||||||||||||||
| Total | $ | $ | ||||||||||||
| December 31, 2025 | ||||||||||||||
| Amortized Cost | Estimated Fair Value | |||||||||||||
| Due in one year or less | $ | $ | ||||||||||||
| Due after one year through five years | ||||||||||||||
| Total | $ | $ | ||||||||||||
In accordance with our investment policy, we place investments in investment grade securities with high credit quality issuers, and generally limit the amount of credit exposure to any one issuer. We evaluate securities for impairment at the end of each reporting period. Impairment is evaluated considering numerous factors, and their relative significance varies depending on the situation.
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Factors considered include whether a decline in fair value below the amortized cost basis is due to credit-related factors or non-credit-related factors, the financial condition and near-term prospects of the issuer, and our intent and ability to hold the investment to allow for an anticipated recovery in fair value. Any impairment that is not credit related is recognized in other comprehensive loss, net of applicable taxes. A credit-related impairment is recognized as an allowance on the balance sheet with a corresponding adjustment to earnings. We did no no
The following table summarizes the amount of gross unrealized losses and the estimated fair value for our available-for-sale securities in an unrealized loss position by the length of time the securities have been in an unrealized loss position as of September 30, 2026 and December 31, 2025 (in millions):
| Less than 12 Months | 12 Months or More | Total | ||||||||||||||||||||||||||||||||||||
| Gross Unrealized Losses | Estimated Fair Value | Gross Unrealized Losses | Estimated Fair Value | Gross Unrealized Losses | Estimated Fair Value | |||||||||||||||||||||||||||||||||
As of September 30, 2026: | ||||||||||||||||||||||||||||||||||||||
| U.S. treasury bills | $ | $ | $ | $ | $ | $ | ||||||||||||||||||||||||||||||||
| U.S. treasury notes | ( | ( | ( | |||||||||||||||||||||||||||||||||||
| Corporate debt securities | ( | ( | ||||||||||||||||||||||||||||||||||||
| Government debt securities | ( | ( | ||||||||||||||||||||||||||||||||||||
| Total | $ | ( | $ | $ | ( | $ | $ | ( | $ | |||||||||||||||||||||||||||||
As of December 31, 2025: | ||||||||||||||||||||||||||||||||||||||
| U.S. treasury bills | $ | $ | $ | $ | $ | $ | ||||||||||||||||||||||||||||||||
| U.S. treasury notes | ( | ( | ( | |||||||||||||||||||||||||||||||||||
| Corporate debt securities | ( | ( | ||||||||||||||||||||||||||||||||||||
| Government debt securities | ||||||||||||||||||||||||||||||||||||||
| Total | $ | ( | $ | $ | ( | $ | $ | ( | $ | |||||||||||||||||||||||||||||
As of September 30, 2026 and December 31, 2025, we held 368 and 108 available-for-sale securities, respectively, out of our total investment portfolio that were in a continuous unrealized loss position. We neither intend to sell these investments, nor do we believe that we are more-likely-than-not to conclude we will have to sell them before recovery of their carrying values. We also believe that we will be able to collect both principal and interest amounts due to us at maturity.
Assets and Liabilities Measured at Fair Value on a Recurring Basis
The following fair value hierarchy is used to classify assets and liabilities based on the observable inputs and unobservable inputs used to value the assets and liabilities:
•Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;
•Level 2: Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability; or
•Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity).
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The following tables summarize our financial assets and liabilities measured at fair value on a recurring basis as of September 30, 2026 and December 31, 2025 (in millions):
| Fair value at September 30, 2026 | Fair Value Measurement Using | |||||||||||||||||||
| Level 1 | Level 2 | |||||||||||||||||||
| Assets: | ||||||||||||||||||||
| Money market funds | $ | $ | $ | |||||||||||||||||
| Certificates of deposit | ||||||||||||||||||||
| U.S. treasury bills | ||||||||||||||||||||
| U.S. treasury notes | ||||||||||||||||||||
| Corporate debt securities | ||||||||||||||||||||
| Government debt securities | ||||||||||||||||||||
Equity investments(1) | ||||||||||||||||||||
Derivative instruments | ||||||||||||||||||||
| Total | $ | $ | $ | |||||||||||||||||
| Liabilities: | ||||||||||||||||||||
Derivative instruments | $ | $ | $ | |||||||||||||||||
| Fair value at December 31, 2025 | Fair Value Measurement Using | |||||||||||||||||||
| Level 1 | Level 2 | |||||||||||||||||||
| Assets: | ||||||||||||||||||||
| Money market funds | $ | $ | $ | |||||||||||||||||
| Certificates of deposit | ||||||||||||||||||||
| U.S. treasury bills | ||||||||||||||||||||
| U.S. treasury notes | ||||||||||||||||||||
| Corporate debt securities | ||||||||||||||||||||
| Government debt securities | ||||||||||||||||||||
Equity Investments(1) | ||||||||||||||||||||
Derivative instruments | ||||||||||||||||||||
| Total | $ | $ | $ | |||||||||||||||||
| Liabilities: | ||||||||||||||||||||
Derivative instruments | $ | $ | $ | |||||||||||||||||
_______
As of September 30, 2026 and December 31, 2025, we did not have non-financial assets or liabilities measured at fair value on a recurring basis and did not have any Level 3 financial assets or financial liabilities.
For the three and nine months ended September 30, 2026, we recognized no net gain or loss and recognized a net loss of $2 million, respectively, on equity investments from changes in fair value of the securities. For the three and nine months ended September 30, 2025, we recognized a net gain of $3 million and a net loss of $5 million, respectively, on equity investments from changes in fair value of the securities.
Fair Value of Other Financial Instruments
We estimate the fair value of our term loan and convertible notes using Level 2 inputs. The fair value of the term loan approximates its carrying value as of September 30, 2026 and December 31, 2025, as the instrument bears interest at a variable rate that reflects current
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market rates. As of September 30, 2026, the estimated fair value of our convertible notes was approximately $3.6 billion, based on quoted market prices in an inactive market. See Note 11 for additional information.
7. Inventory
Inventory as of September 30, 2026 and December 31, 2025 consisted of the following (in millions):
| September 30, | December 31, | |||||||||||||
| 2026 | 2025 | |||||||||||||
| Raw materials | $ | $ | ||||||||||||
| Work in progress | ||||||||||||||
| Finished goods | ||||||||||||||
| Total inventory | $ | $ | ||||||||||||
Inventory, non-current(1) | $ | $ | ||||||||||||
_______
(1)Consisted of raw materials with an anticipated consumption beyond one year. Inventory, non-current is included in other non-current assets in the condensed consolidated balance sheets.
Inventory write-downs as a result of excess, obsolescence, scrap or other reasons, and losses on firm purchase commitments are recorded as a component of cost of sales in our condensed consolidated statements of operations. For the three and nine months ended September 30, 2026, inventory write-downs were $54 million and $133 million, respectively. For the three and nine months ended September 30, 2025, inventory write-downs were $67 million and $147 million, respectively. For the three and nine months ended September 30, 2026, there were no 7 million and $24 million, respectively.
Inventory write-downs were mainly related to inventory in excess of expected demand, shelf-life expiration and other inventory adjustments. Losses on firm purchase commitments were primarily related to excess raw material purchase commitments that will expire before the anticipated consumption of those raw materials.
As of September 30, 2026 and December 31, 2025, we had inventory on hand of $382 million and $267 million, respectively, inclusive of inventory for our COVID, influenza and RSV vaccines. Our raw materials and work-in-progress inventory have variable shelf lives. We expect that the majority of this inventory will be consumed over the next three years . The shelf life of Spikevax is to twelve months . mNEXSPIKE has a shelf life of twelve months . mFLUSIVA has a shelf life of twelve months . The shelf life of mRESVIA is eighteen months .
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8. Property, Plant and Equipment, Net
Property, plant and equipment, net, as of September 30, 2026 and December 31, 2025 consisted of the following (in millions):
| September 30, | December 31, | |||||||||||||
| 2026 | 2025 | |||||||||||||
Land and land improvements | $ | $ | ||||||||||||
Building and building improvements | ||||||||||||||
| Manufacturing and laboratory equipment | ||||||||||||||
Leasehold improvements | ||||||||||||||
| Furniture, fixtures and other | ||||||||||||||
Computer equipment and software | ||||||||||||||
Construction in progress | ||||||||||||||
Right-of-use assets, financing (Note 10) | ||||||||||||||
| Total | ||||||||||||||
Less: Accumulated depreciation | ( | ( | ||||||||||||
| Property, plant and equipment, net | $ | $ | ||||||||||||
Depreciation and amortization expense related to property, plant and equipment for the three and nine months ended September 30, 2026 was $61 million and $173 million, respectively. Depreciation and amortization expense related to property, plant and equipment for the three and nine months ended September 30, 2025 was $51 million and $145 million, respectively.
9. Other Balance Sheet Components
Accounts Receivable, net
Accounts receivable, net, as of September 30, 2026 and December 31, 2025 consisted of the following (in millions):
| September 30, | December 31, | |||||||||||||
| 2026 | 2025 | |||||||||||||
| Accounts receivable | $ | $ | ||||||||||||
Less: Allowance for doubtful accounts | ( | ( | ||||||||||||
| Less: Chargebacks, discounts and fees | ( | ( | ||||||||||||
| Accounts receivable, net | $ | $ | ||||||||||||
Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets, as of September 30, 2026 and December 31, 2025 consisted of the following (in millions):
| September 30, | December 31, | |||||||||||||
| 2026 | 2025 | |||||||||||||
| Prepaid services | $ | $ | ||||||||||||
Research and development funding receivable (Note 5) | ||||||||||||||
Down payments and prepayments related to manufacturing and materials | ||||||||||||||
| Interest receivable | ||||||||||||||
| Value added tax receivable | ||||||||||||||
Prepaid income tax and income tax receivable | ||||||||||||||
Collaboration receivable (Note 5) | ||||||||||||||
| Other current assets | ||||||||||||||
| Prepaid expenses and other current assets | $ | $ | ||||||||||||
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Other Non-Current Assets
Other non-current assets, as of September 30, 2026 and December 31, 2025 consisted of the following (in millions):
| September 30, | December 31, | |||||||||||||
| 2026 | 2025 | |||||||||||||
Income tax receivable, non-current | $ | $ | ||||||||||||
Finite-lived intangible assets, net(1) | ||||||||||||||
Down payments and prepayments, non-current | ||||||||||||||
Deferred tax assets | ||||||||||||||
Inventory, non-current(2) | ||||||||||||||
Goodwill | ||||||||||||||
| Other | ||||||||||||||
| Other non-current assets | $ | $ | ||||||||||||
_______
(1)Includes a $60 million intangible asset related to a license recognized in connection with the settlement agreement with Arbutus and Genevant. See Note 12 for additional details.
Accrued Liabilities
Accrued liabilities, as of September 30, 2026 and December 31, 2025 consisted of the following (in millions):
| September 30, | December 31, | |||||||||||||
| 2026 | 2025 | |||||||||||||
Provisions related to product sales (Note 3) | $ | $ | ||||||||||||
| Compensation-related | ||||||||||||||
| Other external goods and services | ||||||||||||||
| Manufacturing | ||||||||||||||
| Development operations | ||||||||||||||
| Royalties | ||||||||||||||
| Raw materials | ||||||||||||||
| Commercial | ||||||||||||||
| Property, plant and equipment | ||||||||||||||
| Clinical trials | ||||||||||||||
Loss on future firm purchase commitments(1) | ||||||||||||||
| Accrued liabilities | $ | $ | ||||||||||||
______
(1) Related to losses that are expected to arise from firm, non-cancellable, commitments for future raw material purchases (Note 7).
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Other Current Liabilities
Other current liabilities, as of September 30, 2026 and December 31, 2025 consisted of the following (in millions):
| September 30, | December 31, | |||||||||||||
| 2026 | 2025 | |||||||||||||
Lease liabilities - financing (Note 10) | $ | $ | ||||||||||||
Lease liabilities - operating (Note 10) | ||||||||||||||
Collaboration liabilities (Note 5) | ||||||||||||||
Research and development funding liability (Note 5) | ||||||||||||||
| Estimated reimbursements to wholesalers, distributors and customers | ||||||||||||||
| Other | ||||||||||||||
| Other current liabilities | $ | $ | ||||||||||||
Other Non-Current Liabilities
Other non-current liabilities, as of September 30, 2026 and December 31, 2025 consisted of the following (in millions):
| September 30, | December 31, | |||||||||||||
| 2026 | 2025 | |||||||||||||
Tax liabilities | $ | $ | ||||||||||||
Other | ||||||||||||||
Other non-current liabilities | $ | $ | ||||||||||||
Deferred Revenue
The following table summarizes the activities in deferred revenue for the nine months ended September 30, 2026 (in millions):
| December 31, 2025 | Additions | Deductions | September 30, 2026 | |||||||||||||||||||||||
Net product sales | $ | $ | $ | ( | $ | |||||||||||||||||||||
| Other revenue | ( | |||||||||||||||||||||||||
| Total deferred revenue | $ | $ | $ | ( | $ | |||||||||||||||||||||
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10. Leases
We have entered into various long-term, non-cancelable lease arrangements for our facilities and equipment, expiring at various times through 2039. Certain of these arrangements have free rent periods or escalating rent payment provisions. We recognize lease costs under such arrangements on a straight-line basis over the life of the lease. We lease various parcels of land, office, lab, and manufacturing spaces across the globe for our business operations.
Our primary leased campus is our Moderna Science Center (MSC), located in Cambridge, which serves as our headquarters. The MSC, comprising approximately 462,000 square feet, includes our principal executive office and additional office and laboratory spaces. The MSC lease commenced in the third quarter of 2023 and has a term of 15 years, with options for two additional seven-year extensions.
Operating and financing lease right-of-use assets and lease liabilities as of September 30, 2026 and December 31, 2025 were as follows (in millions):
| September 30, | December 31, | |||||||||||||
| 2026 | 2025 | |||||||||||||
| Assets: | ||||||||||||||
Right-of-use assets, operating, net(1) (2) | $ | $ | ||||||||||||
| Total | $ | $ | ||||||||||||
| Liabilities: | ||||||||||||||
| Current: | ||||||||||||||
| $ | $ | |||||||||||||
| Total current lease liabilities | ||||||||||||||
| Non-current: | ||||||||||||||
| Operating lease liabilities, non-current | ||||||||||||||
| Financing lease liabilities, non-current | ||||||||||||||
| Total non-current lease liabilities | ||||||||||||||
| Total | $ | $ | ||||||||||||
_______
(1)These assets are real estate related assets, which include land, office, manufacturing, and laboratory spaces.
(2)Net of accumulated amortization.
(3)These assets are related to contract manufacturing service agreements.
(4)Included in property, plant and equipment in the condensed consolidated balance sheets, net of accumulated depreciation.
(5)Included in other current liabilities in the condensed consolidated balance sheets.
Future minimum lease payments under our non-cancelable lease agreements as of September 30, 2026, were as follows (in millions):
Fiscal Year | Operating Leases | Financing Leases | ||||||||||||
| 2026 | (remainder of the year) | $ | $ | |||||||||||
| 2027 | ||||||||||||||
| 2028 | ||||||||||||||
| 2029 | ||||||||||||||
| 2030 | ||||||||||||||
| Thereafter | ||||||||||||||
Total minimum lease payments | ||||||||||||||
| Less amounts representing interest or imputed interest | ( | ( | ||||||||||||
Present value of lease liabilities | $ | $ | ||||||||||||
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11. Credit Agreement and Convertible Notes
Credit Agreement
In November 2025, we entered into a Credit and Guaranty Agreement (the Credit Agreement) with lenders led by Ares Capital Corporation, as administrative agent. The Credit Agreement provides for a senior secured term loan facility with aggregate term loan commitments of $1.5 billion, consisting of a $600 million initial term loan, which was funded at closing, and $900 million of delayed draw term loan commitments. The initial term loan matures on November 24, 2030. The delayed draw term loan commitments consist of (1) a $400 million delayed draw term loan facility (DDTL-1), which is available, subject to customary conditions, through November 24, 2027, and (2) a $500 million delayed draw term loan facility (DDTL-2), which is available, subject to customary conditions and the achievement of specified regulatory approval milestones for certain product candidates, through November 24, 2028.
Borrowings under the Credit Agreement bear interest at a variable rate equal to, at our option, (i) Term SOFR plus a margin of 5.50 % or (ii) a base rate plus a margin of 4.50 %. The base rate is calculated as the highest of (a) the Wall Street Journal prime rate, (b) the federal funds rate plus one half of one percent and (c) Term SOFR plus one percent. We are also required to pay commitment fees on the undrawn portions of DDTL-1 and DDTL-2. The interest rate applicable to the initial term loan was approximately 9.23 % and 9.38 % as of September 30, 2026 and December 31, 2025, respectively.
The obligations under the Credit Agreement are guaranteed by certain of our subsidiaries and are secured by a first-priority lien on substantially all of our assets, in each case subject to customary exceptions and limitations. The Credit Agreement is subject to compliance with customary representations and warranties, affirmative covenants, restrictive covenants and events of default. The restrictive covenants, subject to specified limitations and exceptions, limit, among other things, our ability to incur additional indebtedness and liens, make certain investments, engage in certain fundamental changes, dispose of assets and make restricted payments. Events of default under the Credit Agreement include, among others, nonpayment of principal, interest or other amounts when due, failure to comply with covenants (subject to applicable notice and cure periods), breaches of certain representations and warranties, the occurrence of certain significant adverse events and certain insolvency-related events. The Credit Agreement also includes a financial covenant requiring us to maintain minimum cash and cash equivalents (as defined in the Credit Agreement, which primarily consist of our cash, cash equivalents, and available-for-sale securities) as of the last business day of each week of at least $500 million, increasing to $750 million if more than $1.0 billion is drawn under the Credit Agreement. The financial covenant is not required to be tested at any time that the trailing 30 -day average market capitalization of the Company exceeds $5.0 billion and is subject to a customary equity cure. As of September 30, 2026 and December 31, 2025, we were in compliance with the applicable terms and covenants under the Credit Agreement.
As of September 30, 2026 and December 31, 2025, the initial term loan had an outstanding principal balance of $600 591 million and $590 million, respectively, net of unamortized original issue discount and debt issuance costs. The carrying amount was classified as long-term debt in our condensed consolidated balance sheet. No amounts had been drawn under DDTL-1 or DDTL-2. The principal amount of $600
Convertible Notes
On September 1, 2026, we issued $3.0 billion aggregate principal amount of 0.00 % Convertible Senior Notes due 2032 (the 2032 Notes), which included the exercise in full of the initial purchasers’ option to purchase an additional $400 million aggregate principal amount of the 2032 Notes. The 2032 Notes are our senior unsecured obligations and mature on March 1, 2032, unless earlier converted, redeemed or repurchased. The 2032 Notes do not bear regular interest, and the principal amount of the 2032 Notes does not accrete. Special interest may accrue under certain circumstances as provided in the indenture governing the 2032 Notes.
Prior to the close of business on the business day immediately preceding December 1, 2031, holders may convert all or any portion of the 2032 Notes only under the following circumstances: (i) during any calendar quarter commencing after the calendar quarter ending December 31, 2026, if the last reported sale price of our common stock is at least 150 % of the then-current conversion price for at least 20 trading days during the 30 consecutive trading day period ending on, and including, the last trading day of the immediately preceding calendar quarter; (ii) during the five business day period following any 10 consecutive trading day period in which the trading price per $1,000 principal amount of the 2032 Notes for each trading day during such period is less than 98 % of the product of the last reported sale price of our common stock and the applicable conversion rate on each such trading day; (iii) if we call the 2032 Notes for redemption, at any time prior to the close of business on the second scheduled trading day immediately preceding the
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redemption date, with respect to the 2032 Notes called for redemption; or (iv) upon the occurrence of certain specified corporate events. On or after December 1, 2031 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of the 2032 Notes at any time.
Upon conversion, we may elect to settle the 2032 Notes in cash, shares of our common stock, or a combination of cash and shares of our common stock. The initial conversion rate is 4.7487 shares of our common stock per $1,000 principal amount of the 2032 Notes, equivalent to an initial conversion price of approximately $210.58 per share. The initial conversion price represents a premium of approximately 47.5 % over the closing price of our common stock on August 27, 2026. Based on the initial conversion rate, the 2032 Notes are initially convertible into approximately 14 million shares of our common stock and, in certain limited circumstances, may be convertible into a maximum of approximately 21 million shares. The conversion rate is subject to adjustment upon the occurrence of certain events. In addition, following certain corporate events occurring prior to maturity or if we deliver a notice of redemption, we will, in certain circumstances, increase the conversion rate for holders who elect to convert their 2032 Notes in connection with such corporate event or during the related redemption period.
We may redeem for cash all or any portion of the 2032 Notes, at our option, on or after September 6, 2029 and before the 21st scheduled trading day immediately preceding the maturity date if the last reported sale price of our common stock has been at least 130 % of the then-current conversion price for at least 20 trading days during any 30 consecutive trading day period, including the last trading day of such period, ending on, and including, the trading day immediately preceding the date on which we provide the related notice of redemption. The redemption price is equal to 100 % of the principal amount of the 2032 Notes to be redeemed, plus accrued and unpaid special interest, if any. If we undergo a fundamental change, as defined in the indenture, holders may, subject to certain conditions, require us to repurchase for cash all or any portion of their 2032 Notes at a price equal to 100 % of the principal amount of the 2032 Notes to be repurchased, plus accrued and unpaid special interest, if any. The conditions allowing holders to convert the 2032 Notes were not met as of September 30, 2026.
We received net proceeds of approximately $3.0 billion from the issuance of the 2032 Notes, net of issuance costs. The 2032 Notes are accounted for in their entirety as a liability, as the embedded conversion features are indexed to our common stock and meet the criteria for the own-equity scope exception from derivative accounting. Debt issuance costs of approximately $43 million associated with the 2032 Notes are being amortized to interest expense over the contractual term of the 2032 Notes using the effective interest method. As of September 30, 2026, the net carrying amount of the 2032 Notes was $3.0 billion, net of unamortized debt issuance costs of $42 million, and was classified as a long-term liability on our condensed consolidated balance sheet.
Capped Call Transactions
On August 27, 2026, in connection with the pricing of the 2032 Notes, and on August 28, 2026, in connection with the exercise in full of the initial purchasers’ option to purchase additional 2032 Notes, we entered into privately negotiated capped call transactions (the Capped Call Transactions) with certain financial institutions. We paid an aggregate premium of $329 million for the Capped Call Transactions using a portion of the net proceeds from the issuance of the 2032 Notes. The Capped Call Transactions are call options on our common stock and initially cover, subject to customary adjustments, approximately 14 million shares of our common stock, corresponding to the number of shares initially underlying the 2032 Notes. The Capped Call Transactions have an initial strike price of approximately $210.58 per share, which corresponds to the initial conversion price of the 2032 Notes, and an initial cap price of approximately $392.62 per share, representing a premium of approximately 175 % over the closing price of our common stock on August 27, 2026. The strike price, cap price and number of shares underlying the Capped Call Transactions are subject to adjustment under certain circumstances.
The Capped Call Transactions are expected generally to reduce potential dilution to our common stock upon conversion of the 2032 Notes and/or offset potential cash payments we may be required to make in excess of the principal amount of converted 2032 Notes, in each case to the extent the market price of our common stock, determined in accordance with the terms of the Capped Call Transactions, exceeds the strike price, with such reduction in potential dilution and/or offset of cash payments subject to the cap price.
The Capped Call Transactions are separate transactions from the 2032 Notes and are indexed to our common stock and qualify for equity classification. Accordingly, we recorded the $329 million purchase price as a reduction to additional paid-in capital on our condensed consolidated balance sheet, and the Capped Call Transactions are not subsequently remeasured.
12. Commitments and Contingencies
Legal Proceedings
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We are a party to various legal proceedings and claims. Accruals are recognized for legal matters when a loss is both probable and reasonably estimable. As of September 30, 2026, no material contingent liabilities have been recognized. If a material loss is reasonably possible and we can estimate the amount or range of the loss, we disclose such information. Unless otherwise noted, either the outcome of these matters is not expected to be material, or the potential loss cannot be reasonably estimated.
From time to time, we may be a party to litigation, arbitration, or other legal proceedings in the course of our business. The outcome of such matters is inherently uncertain and often involves significant judgment in assessing risk and estimating potential exposure. While we do not currently expect any pending proceedings to have a material adverse effect on our financial position, results of operations, or cash flows, there can be no assurance that future developments will not have a material impact.
On March 3, 2026, we entered into a settlement agreement with Arbutus Biopharma Corporation (Arbutus) and Genevant Sciences GmbH (Genevant, and with Arbutus, Arbutus/Genevant) resolving all litigation worldwide, including between the parties in the U.S. District Court for the District of Delaware. The settlement resolves all worldwide Arbutus/Genevant litigation related to Spikevax and mRESVIA and provides certainty going forward for our full infectious disease portfolio, including mNEXSPIKE, mCOMBRIAX, mFLUSIVA and our future vaccine pipeline, with no future royalties owed. Under the terms of the agreement, we agreed to make a lump sum payment of $950 million, which we paid in July 2026. In the three months ended March 31, 2026, we recorded $876 million in cost of sales and capitalized $74 million as an intangible asset on the settlement date, representing the estimated value attributed to a license to certain intellectual property rights, which is being amortized on a straight-line basis over an estimated useful life of approximately three years . As of September 30, 2026, the carrying value of the intangible asset was $60 million. Consistent with the terms of the settlement agreement, we have appealed the District Court’s decision related to 28 U.S.C. § 1498 to the Federal Circuit Court of Appeals and could be required to make an additional payment of up to $1.3 billion depending on the outcome of the appeal. As of September 30, 2026, no accrual has been recorded for this amount as a loss is not considered probable.
The following summarizes our other significant legal proceedings and matters outstanding as of September 30, 2026.
We brought patent-infringement actions against Pfizer Inc. (Pfizer), BioNTech SE (BioNTech) and related entities in the U.S., Germany, the Netherlands, the UK, Ireland and Belgium concerning our mRNA platform technology and disease-specific vaccine designs. Pfizer and BioNTech commenced actions or asserted defenses seeking to revoke our patents in these jurisdictions. In September 2026, the Technical Board of Appeal of the European Patent Office revoked our European Patent No. 3 590 949 in all contracting states, including Germany, the Netherlands, the UK, Ireland, and Belgium. Following this decision, the related national proceedings in Belgium, Ireland, and the Netherlands have been dismissed. Proceedings in Germany and the UK remain pending awaiting the written decision of the Technical Board of Appeal.
We have filed a complaint against Pfizer, BioNTech, and certain of their affiliates in the Hamburg Local Division of the Unified Patent Court (UPC) asserting a European Patent concerning modified mRNA vaccines formulated in lipid nanoparticles.
Northwestern University has filed a complaint against us in the U.S. District Court for the District of Delaware asserting U.S. patents concerning lipid nanoparticle technology.
Bayer CropSciences LLC, Monsanto Company, and Monsanto Technology, LLC have filed a complaint against us in the U.S. District Court for the District of Delaware asserting a U.S. patent directed to methods of modifying gene sequences.
mNG Bio, LLC has filed a complaint against us in the U.S District Court for the District of Massachusetts asserting a U.S. patent directed to a yellow-green fluorescent protein.
BioNTech SE has filed a complaint against us in the U.S. District Court for the District of Delaware asserting a U.S. patent directed to modified mRNA compositions encoding a spike protein fragment.
CureVac SE and CureVac Manufacturing GmbH have filed a complaint against us in the U.S. District Court for the District of Delaware asserting U.S. patents directed to RNA production methods and compositions with RNA encoding modified SARS-CoV-2 spike protein.
CureVac Manufacturing GmbH has filed a complaint against us and certain of our affiliates in the Hague Local Division of the UPC asserting a European patent related to mRNA production and purification methods.
CureVac SE has filed complaints against certain of our affiliates in Spain and Switzerland asserting a European patent related to mRNA compositions with increased guanine and cytosine content.
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Translate Bio, Inc., Translate Bio MA, Inc., Sanofi Vaccines US, Inc., and VaxServe, Inc. (all subsidiaries of Sanofi SA) have filed a complaint against us in the U.S. District Court for the District of New Jersey asserting U.S. patents related to compositions and methods for mRNA delivery.
Shareholder class action and shareholder derivative complaints were brought against us in the U.S. District Court for the District of Massachusetts related to statements about our RSV vaccine (mRNA-1345). The class action litigation was dismissed with prejudice and the decision is subject to appeal.
Indemnification Obligations
As permitted under Delaware law, we indemnify our officers, directors, and employees for certain events, occurrences while the officer, or director is, or was, serving at our request in such capacity. The term of the indemnification is for the officer’s or director’s lifetime.
We have standard indemnification arrangements in our leases for laboratory and office space that require us to indemnify the landlord against any liability for injury, loss, accident, or damage from any claims, actions, proceedings, or costs resulting from certain acts, breaches, violations, or non-performance under our leases.
We enter into indemnification provisions under our agreements with counterparties in the ordinary course of business, typically with business partners, contractors, clinical sites and customers. Under these provisions, we generally indemnify and hold harmless the indemnified party for losses suffered or incurred by the indemnified party as a result of our activities. These indemnification provisions generally survive termination of the underlying agreement. The maximum potential amount of future payments we could be required to make under these indemnification provisions is unlimited.
Through the three and nine months ended September 30, 2026 and the year ended December 31, 2025, we had no no no
Licenses to Patented Technology
We have patent license agreements with Cellscript, LLC and its affiliate, mRNA RiboTherapeutics, Inc., and the National Institute of Allergy and Infectious Diseases (NIAID), an Institute of the National Institutes of Health (NIH). Under these agreements, we are required to pay royalties and certain milestone payments. For further information on our licensing and royalty payments, please refer to our 2025 Form 10-K under the heading “Business—Intellectual Property—In-licensed intellectual property” and Note 12 to our consolidated financial statements contained therein.
In January 2025, we entered into a non-exclusive patent license agreement with NIAID to license certain patent rights related to the development of mRNA-based vaccines for the prevention or treatment of RSV infection. Upon execution of the agreement, we made a total payment of $10 million, which was capitalized as an intangible asset and is amortized to cost of sales on a straight-line basis over the estimated useful life of the licensed patents. In addition, we are obligated to pay low single-digit royalties on future net sales of licensed products.
For the three and nine months ended September 30, 2026, we recognized $65 million and $971 million, respectively, of royalty expenses associated with our product sales, including amortization of certain intangible assets. The royalty expense recognized for the three and nine months ended September 30, 2026 included $6 million and $890 million, respectively, related to the litigation settlement with Arbutus and Genevant. For the three and nine months ended September 30, 2025, we recognized $43 million and $54 million, respectively, of royalty expenses. These royalty expenses were recorded to cost of sales in our condensed consolidated statements of operations.
Additionally, we have other in-license agreements with third parties which require us to make future development, regulatory and commercial milestone payments and sales-based royalties for specified products associated with the agreements. The achievement of these milestones have not yet occurred as of September 30, 2026.
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13. Stock-Based Compensation and Share Repurchase Programs
Stock-Based Compensation
The following table presents the components and classification of stock-based compensation expense for the three and nine months ended September 30, 2026 and 2025 as follows (in millions):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||||||||||
Options | $ | $ | $ | $ | ||||||||||||||||||||||
Restricted Stock Units (RSUs) | ||||||||||||||||||||||||||
Performance Stock Units (PSUs) | ||||||||||||||||||||||||||
| Employee Stock Purchase Plan (ESPP) | ||||||||||||||||||||||||||
Total | $ | $ | $ | $ | ||||||||||||||||||||||
| Cost of sales | $ | $ | $ | $ | ||||||||||||||||||||||
| Research and development | ||||||||||||||||||||||||||
| Selling, general and administrative | ||||||||||||||||||||||||||
Total | $ | $ | $ | $ | ||||||||||||||||||||||
As of September 30, 2026, there was $722 million of total unrecognized compensation cost related to unvested stock-based compensation with respect to options, RSUs and PSUs granted. That cost is expected to be recognized over a weighted-average period of 2.6 years as of September 30, 2026.
Share Repurchase Programs
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14. Income Taxes
The following table summarizes our income tax expense for the periods presented (in millions, except for percentages):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||||||||||
| Income (loss) before taxes | $ | $ | ( | $ | ( | $ | ( | |||||||||||||||||||
| Provision for income taxes | $ | $ | $ | $ | ||||||||||||||||||||||
| Effective tax rate | % | ( | % | ( | % | ( | % | |||||||||||||||||||
The effective tax rate for the three months ended September 30, 2026 was lower than the statutory rate, primarily due to our expected full-year loss position and the continued maintenance of our global valuation allowance, which limits our ability to recognize tax benefits associated with the loss. For the nine months ended September 30, 2026, the effective tax rate was higher than the statutory rate, primarily because certain of our foreign subsidiaries generated taxable income while we incurred a consolidated pre-tax loss and maintained a global valuation allowance that limits our ability to recognize tax benefits from the loss. The effective tax rate for the three and nine months ended September 30, 2026 continued to be significantly impacted by the maintenance of our global valuation allowance. For additional details regarding our deferred tax assets and the policies governing our valuation allowance, please refer to Note 14 to our consolidated financial statements in our 2025 Form 10-K.
We periodically reassess the need for valuation allowances on our deferred tax assets, considering both positive and negative evidence to evaluate whether it is more likely than not that all or a portion of such assets will not be realized. Significant management judgment is required in assessing the realizability of our deferred tax assets. In the event that actual results differ from our estimates, we adjust our estimates in future periods and we may need to modify our valuation allowance, which could materially impact our financial position and results of operations.
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15. Net Earnings (Loss) per Share
The computation of basic earnings (loss) per share (EPS) is based on the weighted-average number of our common shares outstanding. The computation of diluted EPS is based on the weighted-average number of our common shares outstanding and potential dilutive common shares during the period as determined by using the treasury stock method for equity awards and the if-converted method for our convertible notes.
Basic and diluted EPS for the three and nine months ended September 30, 2026 and 2025 were calculated as follows (in millions, except per share data):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||||||||||
| Numerator: | ||||||||||||||||||||||||||
| Net income (loss) | $ | $ | ( | $ | ( | $ | ( | |||||||||||||||||||
| Interest expense on the convertible notes, net of tax | ||||||||||||||||||||||||||
| Net income (loss), for use in diluted EPS | $ | $ | ( | $ | ( | $ | ( | |||||||||||||||||||
| Denominator: | ||||||||||||||||||||||||||
| Basic weighted-average common shares outstanding | ||||||||||||||||||||||||||
| Effect of dilutive securities: | ||||||||||||||||||||||||||
| Equity awards | ||||||||||||||||||||||||||
| Convertible notes | ||||||||||||||||||||||||||
| Diluted weighted-average common shares outstanding | ||||||||||||||||||||||||||
| Basic EPS | $ | $ | ( | $ | ( | $ | ( | |||||||||||||||||||
| Diluted EPS | $ | $ | ( | $ | ( | $ | ( | |||||||||||||||||||
| Common stock equivalents excluded from the EPS computation above because their inclusion would have been anti-dilutive (in millions): | ||||||||||||||||||||||||||
| Equity awards | ||||||||||||||||||||||||||
| Convertible notes | ||||||||||||||||||||||||||
| Total | ||||||||||||||||||||||||||
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2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited financial information and related notes included in this Form 10-Q and our consolidated financial statements and related notes and other financial information in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, which was filed with the Securities and Exchange Commission (the SEC) on February 20, 2026 (the 2025 Form 10-K).
Overview
We are a biotechnology company advancing a new class of medicines made of messenger RNA (mRNA). mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that have a therapeutic or preventive benefit with the potential to address a broad spectrum of diseases. Our platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing us the capability to pursue in parallel a robust pipeline of new development candidates.
Since our founding in 2010, we have transformed from a research-stage company advancing programs in the field of mRNA to a commercial enterprise with a diverse clinical portfolio of vaccines and therapeutics across several modalities, a broad intellectual property portfolio and integrated manufacturing capabilities that allow for rapid clinical and commercial production at scale. We currently have five approved products—Spikevax® and mNEXSPIKE®, our COVID vaccines; mRESVIA®, our vaccine against respiratory syncytial virus (RSV); our flu plus COVID combination vaccine, which was authorized for individuals 50 years of age and older in Europe (marketed as mCOMBRIAX®) and in Canada (marketed as mCOFLU®); and mFLUSIVA® , our influenza vaccine, which was approved in the United States and Canada for individuals 50 years of age and older.
In addition to our commercial products, we are advancing a diverse pipeline of development candidates across infectious disease vaccines, oncology therapeutics, and rare disease therapeutics. Within our oncology therapeutics modality, we and Merck & Co., Inc. (Merck) are jointly developing intismeran autogene (mRNA-4157), a novel investigational mRNA-based individualized neoantigen therapy. We and Merck are advancing a robust clinical development program for intismeran, which currently consists of nine total Phase 2 and Phase 3 clinical trials across multiple tumor types and stages of disease.
Business Highlights
Positive Phase 3 Results for Intismeran Autogene in Adjuvant Melanoma
In August 2026, we and Merck announced positive topline results from the Phase 3 INTerpath-001 trial evaluating adjuvant treatment with intismeran in combination with KEYTRUDA (pembrolizumab), Merck's anti-PD-1 therapy, in patients with completely resected stage IIB-IV melanoma. At a pre-specified interim analysis, the trial met its primary endpoint of recurrence-free survival (RFS) and a key secondary endpoint of distant metastasis-free survival (DMFS), with the combination demonstrating statistically significant and clinically meaningful improvements in RFS and DMFS compared with KEYTRUDA alone. RFS measures the time until disease recurrence or death, and DMFS measures the time until distant metastasis or death.
In October 2026, we and Merck presented detailed positive RFS and DMFS results during Presidential Symposium I at the European Society for Medical Oncology (ESMO) Congress 2026. After a median follow-up of 24.6 months, intismeran in combination with KEYTRUDA significantly reduced the risk of recurrence or death by 42% (HR=0.58 [95% CI, 0.45–0.75]; two-sided p<0.001). Intismeran plus KEYTRUDA also significantly reduced the risk of distant metastasis or death by 38% (HR=0.62 [95% CI, 0.45–0.85]; two-sided p=0.002) compared to KEYTRUDA alone. The improvements observed in RFS and DMFS were generally consistent across pre-specified patient subgroups. Overall survival (OS) data are not yet mature, but a favorable trend in OS with intismeran plus KEYTRUDA has been observed. The study remains ongoing to further evaluate OS and other key endpoints. The safety profile of intismeran plus KEYTRUDA was generally consistent with previously reported studies of the combination, with no new safety signals observed.
The efficacy of the intismeran immunization plus KEYTRUDA in the first six months was comparable with KEYTRUDA alone for risk of recurrence or death (HR=0.99 [95% CI, 0.66–1.49]) and risk of distant metastasis or death (HR=1.01 [95% CI, 0.58–1.79]). At six months, following the intismeran immunization regimen, a pre-specified sensitivity analysis of the primary endpoint showed the addition of intismeran plus KEYTRUDA reduced the risk of recurrence or death by 58% (HR=0.42 [95% CI, 0.30–0.58]) and reduced the risk of distant metastasis or death by half (HR=0.50 [95% CI, 0.34–0.73]) compared to KEYTRUDA alone.
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FDA Approval and Commercial Launch of mFLUSIVA
In August 2026, the U.S. Food and Drug Administration (FDA) approved mFLUSIVA (mRNA-1010), our seasonal influenza vaccine, for use in adults 50 years of age and older. The approval for adults 50 through 64 years of age was based on results from a randomized, observer-blind, active-controlled Phase 3 clinical trial that enrolled 40,805 adults across 11 countries. The primary objectives of the study were to evaluate the safety and reactogenicity of mFLUSIVA and its relative vaccine efficacy compared with a standard-dose influenza vaccine against reverse transcription polymerase chain reaction (RT-PCR)-confirmed protocol-defined influenza-like illness caused by influenza A or B strains. For adults 65 years of age and older, accelerated approval was based on results from a separate randomized, observer-blind, active-controlled clinical trial that enrolled 2,992 adults in the United States. The primary objective of this study was to evaluate the immunogenicity of mFLUSIVA compared with a high-dose inactivated influenza vaccine. Effectiveness in this population was also supported by a descriptive analysis of relative vaccine efficacy from the Phase 3 efficacy study described above. Clinical benefit in adults 65 years of age and older will be further assessed in a postmarketing confirmatory clinical trial. The Phase 3 program demonstrated an acceptable safety profile, with no new safety concerns identified.
We launched commercial sales of mFLUSIVA in the United States in September 2026 for the 2026–2027 respiratory virus season. We have also received approval for mFLUSIVA in Canada. mRNA-1010 is also under regulatory review in the European Union, Australia and Taiwan.
Issuance of Convertible Senior Notes
In September 2026, we issued $3.0 billion aggregate principal amount of 0.00% Convertible Senior Notes due 2032 (the 2032 Notes) and received net proceeds of approximately $3.0 billion. The 2032 Notes mature in March 2032, unless earlier converted, redeemed or repurchased, do not bear regular interest and, upon conversion, may be settled in cash, shares of our common stock or a combination of cash and shares, at our election. In connection with the issuance of the 2032 Notes, we entered into capped call transactions at an aggregate cost of $329 million, with the transactions expected generally to reduce potential dilution to our common stock upon conversion of the 2032 Notes and/or offset potential cash payments in excess of the principal amount of converted notes, subject to a cap. We intend to use the remaining net proceeds for general corporate purposes, which may include investments in the growth of our oncology business and repayment of debt. See Note 11 to our condensed consolidated financial statements for additional information.
Total Revenue and Net Loss Per Share
For the third quarter of 2026, we recognized total revenue of $1.3 billion, compared to $1.0 billion for the third quarter of 2025. Diluted earnings per share was $0.38 for the third quarter of 2026, compared to loss per share of $(0.51) for the third quarter of 2025.
Additional Program Developments
Infectious Disease Vaccines
•COVID vaccines: In August 2026, we announced that the FDA has approved the supplemental Biologics License Applications (sBLA) for the 2026-2027 formulas for Spikevax and mNEXSPIKE, containing the JN.1-lineage XFG subvariant of SARS-CoV-2 to help prevent COVID-19.
•Seasonal flu + COVID vaccine: We received regulatory approval in Canada for mCOFLU, our seasonal flu + COVID combination vaccine. The vaccine is also approved in the EU under the brand name mCOMBRIAX. The vaccine remains under regulatory review in additional markets, including Japan, the UK and Australia. We continue to await further guidance from the FDA regarding refiling in the United States.
•Norovirus vaccine: Following the Phase 3 interim analysis, which did not meet the statistical criteria for early success, we do not plan to initiate an additional cohort this season. We intend to engage with health authorities to determine the programs path forward.
•Bundibugyo ebolavirus vaccine: In August 2026, we announced initiation of a Phase 1 clinical trial of mRNA-1469, our investigational vaccine against bundibugyo ebolavirus. The trial will evaluate safety and immune response for a strain of Ebola virus disease with no licensed vaccines indicated, and is being conducted in Canada as part of our expanded collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI). In November 2026, we announced that mRNA-1469 has been recommended to advance into a Phase 2/3 efficacy study in the Democratic Republic of Congo (DRC), supported by encouraging preclinical and Phase 1 clinical data.
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Oncology Therapeutics
•Intismeran autogene: We are advancing mRNA-4157 in collaboration with Merck evaluating the safety and efficacy of intismeran in combination with KEYTRUDA and other anti-cancer therapies, and as a monotherapy. The INTerpath program currently consists of nine total Phase 2 and Phase 3 clinical trials underway across multiple tumor types and stages of disease, including three ongoing Phase 3 trials in non-small cell lung cancer (NSCLC). Additional studies include a Phase 2b trial in adjuvant melanoma and Phase 1 study exploring adjuvant pancreatic ductal adenocarcinoma, perioperative gastric carcinoma and perioperative NSCLC.
•mRNA-2808: An abstract was accepted for oral presentation at the American Society of Hematology (ASH) Annual Meeting in December 2026.
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Our Pipeline
The following chart shows our current pipeline of development programs across our several modalities.
Abbreviations: CMV, cytomegalovirus; EBV, Epstein-Barr virus; HIV, human immunodeficiency virus; hMPV, human metapneumovirus; MIBC, muscle invasive bladder cancer; NMIBC, non-muscle invasive bladder cancer; NSCLC, non-small cell lung cancer; pCR, pathological complete response; RCC, renal cell carcinoma; RSV, respiratory syncytial virus.
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Results of operations
The following table summarizes our condensed consolidated statements of operations for the periods presented (in millions):
| Three Months Ended September 30, | Change 2026 vs. 2025 | ||||||||||||||||||||||
| 2026 | 2025 | $ | % | ||||||||||||||||||||
| Revenue: | |||||||||||||||||||||||
| Net product sales | $ | 1,273 | $ | 973 | $ | 300 | 31% | ||||||||||||||||
| Other revenue | 40 | 43 | (3) | (7)% | |||||||||||||||||||
| Total revenue | 1,313 | 1,016 | 297 | 29% | |||||||||||||||||||
| Operating expenses: | |||||||||||||||||||||||
| Cost of sales | 318 | 207 | 111 | 54% | |||||||||||||||||||
| Research and development | 583 | 801 | (218) | (27)% | |||||||||||||||||||
| Selling, general and administrative | 282 | 268 | 14 | 5% | |||||||||||||||||||
| Total operating expenses | 1,183 | 1,276 | (93) | (7)% | |||||||||||||||||||
| Income (loss) from operations | 130 | (260) | 390 | 150% | |||||||||||||||||||
| Interest income | 62 | 73 | (11) | (15)% | |||||||||||||||||||
| Other (expense) income, net | (21) | — | (21) | (100)% | |||||||||||||||||||
| Income (loss) before taxes | 171 | (187) | 358 | 191% | |||||||||||||||||||
| Provision for income taxes | 9 | 13 | (4) | (31)% | |||||||||||||||||||
| Net income (loss) | $ | 162 | $ | (200) | $ | 362 | 181% | ||||||||||||||||
| Nine Months Ended September 30, | Change 2026 vs. 2025 | ||||||||||||||||||||||
| 2026 | 2025 | $ | % | ||||||||||||||||||||
| Revenue: | |||||||||||||||||||||||
| Net product sales | $ | 1,719 | $ | 1,172 | $ | 547 | 47% | ||||||||||||||||
| Other revenue | 128 | 94 | 34 | 36% | |||||||||||||||||||
| Total revenue | 1,847 | 1,266 | 581 | 46% | |||||||||||||||||||
| Operating expenses: | |||||||||||||||||||||||
| Cost of sales | 1,366 | 416 | 950 | 228% | |||||||||||||||||||
| Research and development | 1,883 | 2,357 | (474) | (20)% | |||||||||||||||||||
| Selling, general and administrative | 671 | 710 | (39) | (5)% | |||||||||||||||||||
| Total operating expenses | 3,920 | 3,483 | 437 | 13% | |||||||||||||||||||
| Loss from operations | (2,073) | (2,217) | 144 | (6)% | |||||||||||||||||||
| Interest income | 201 | 244 | (43) | (18)% | |||||||||||||||||||
| Other (expense) income, net | (58) | 4 | (62) | (1,550)% | |||||||||||||||||||
| Loss before income taxes | (1,930) | (1,969) | 39 | (2)% | |||||||||||||||||||
| Provision for income taxes | 33 | 27 | 6 | 22% | |||||||||||||||||||
| Net loss | $ | (1,963) | $ | (1,996) | $ | 33 | (2)% | ||||||||||||||||
Revenue
Net product sales
Net product sales by customer geographic location were as follows (in millions):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||||||||||
| United States | $ | 771 | $ | 782 | $ | 914 | $ | 901 | ||||||||||||||||||
| Europe | 314 | 16 | 569 | 16 | ||||||||||||||||||||||
Rest of world | 188 | 175 | 236 | 255 | ||||||||||||||||||||||
| Total | $ | 1,273 | $ | 973 | $ | 1,719 | $ | 1,172 | ||||||||||||||||||
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Net product sales by product were as follows (in millions):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||||||||||
COVID(1) | $ | 1,244 | $ | 971 | $ | 1,680 | $ | 1,168 | ||||||||||||||||||
| RSV | 29 | 2 | 39 | 4 | ||||||||||||||||||||||
| Total | $ | 1,273 | $ | 973 | $ | 1,719 | $ | 1,172 | ||||||||||||||||||
_______
(1) Includes sales of Spikevax and mNEXSPIKE.
As of September 30, 2026, we have five approved products, our COVID vaccines, Spikevax and mNEXSPIKE, our RSV vaccine, mRESVIA, our flu and COVID combination vaccine, mCOMBRIAX, which has received European Commission marketing authorization in the EU, and our influenza vaccine, mFLUSIVA, which has been approved in the United States. We launched commercial sales of mNEXSPIKE in the third quarter of 2025. As of September 30, 2026, mCOMBRIAX had not been commercialized. In August 2026, mFLUSIVA was approved by the FDA for the prevention of influenza disease in adults 50 years of age and older, and we launched commercial sales of mFLUSIVA in September 2026. Net product sales of mFLUSIVA were immaterial for the quarter, reflecting the timing of the approval and launch relative to the 2026–2027 influenza contracting season, as well as uncertainty regarding uptake of mFLUSIVA during the season.
We sell our vaccines to the commercial market as well as to governments and international organizations. In the U.S., our vaccines are sold primarily to wholesalers and distributors, and to a lesser extent, directly to retailers, healthcare providers and government entities. Net product sales are recognized net of estimated chargebacks, fulfillment fees, prompt-pay discounts, provisions for sales returns and government rebates, and other related deductions.
The following table summarizes product sales provision adjustments for the periods presented (in millions):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||||||||||
| Gross product sales | $ | 2,597 | $ | 1,971 | $ | 3,069 | $ | 2,251 | ||||||||||||||||||
Product sales provision: | ||||||||||||||||||||||||||
| Chargebacks, discounts and fees | (1,070) | (762) | (1,109) | (846) | ||||||||||||||||||||||
Returns, rebates and other fees | (254) | (236) | (241) | (233) | ||||||||||||||||||||||
Total product sales provision adjustments | $ | (1,324) | $ | (998) | $ | (1,350) | $ | (1,079) | ||||||||||||||||||
| Net product sales | $ | 1,273 | $ | 973 | $ | 1,719 | $ | 1,172 | ||||||||||||||||||
Certain agreements may include upfront payments for our vaccine supply, initially recorded as deferred revenue. As of September 30, 2026, we had deferred revenue of $218 million related to product sales, of which $160 million is expected to be realized in less than one year.
Other revenue
Other revenue comprises grant revenue, collaboration revenue, licensing and royalty revenue, and stand-ready manufacturing revenue.
For the three months ended September 30, 2026, total revenue increased by $297 million, or 29%, compared to the same period in 2025, primarily driven by a $300 million, or 31%, increase in net product sales. For the nine months ended September 30, 2026, total revenue increased by $581 million, or 46%, compared to the same period in 2025, primarily driven by a $547 million, or 47%, increase in net product sales. The increase in net product sales in both periods was mainly due to higher COVID vaccine sales in international markets, driven by deliveries under long-term strategic partnerships with government entities. Net product sales in the U.S. were generally consistent with the corresponding periods in 2025. Other revenue remained relatively consistent for the three months ended September 30, 2026 compared to the same period in 2025. For the nine months ended September 30, 2026, other revenue increased by $34 million, or 36%, compared to the same period, primarily due to higher stand-ready manufacturing revenue, including from facilities that became operational during the second half of 2025, and higher collaboration revenue, mainly related to our collaboration with Recordati for our investigational propionic acidemia therapeutic, mRNA-3927.
Product sales are expected to return to growth in 2026, supported by the full-year impact of long-term strategic partnerships with government entities.
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Operating expenses
Cost of sales
Cost of sales for the three months ended September 30, 2026 was $318 million, which included third-party royalties of $65 million, inventory write-downs of $54 million, and unutilized manufacturing capacity costs of $29 million. Cost of sales for the nine months ended September 30, 2026 was $1.4 billion, which included third-party royalties of $971 million, inventory write-downs of $133 million, and unutilized manufacturing capacity costs of $54 million. Third-party royalties included $6 million and $890 million for the three and nine months ended September 30, 2026, respectively, related to the litigation settlement with Arbutus and Genevant and amortization of the associated intangible asset. Please refer to Note 12, Commitments and Contingencies, to our condensed consolidated financial statements for additional information. Inventory write-downs in 2026 primarily related to our finished and semi-finished vaccine inventory and raw materials relative to updated demand forecasts, shelf-life expiration and other adjustments. Please refer to Note 7 to our condensed consolidated financial statements for inventory related charges.
Cost of sales for the three months ended September 30, 2026 increased by $111 million, or 54%, compared to the same period in 2025. Cost of sales as a percentage of net product sales and stand-ready manufacturing revenue for the three months ended September 30, 2026 was 24%, compared to 21% for the same period in 2025. The increases were primarily due to higher product sales volume and higher unutilized manufacturing costs. Cost of sales for the nine months ended September 30, 2026 increased by $950 million, or 228%, compared to the same period in 2025. Cost of sales as a percentage of net product sales and stand-ready manufacturing revenue for the nine months ended September 30, 2026 was 75%, compared to 34% for the same period in 2025. The increase was primarily driven by litigation settlement-related expenses. Excluding these expenses, cost of sales increased by 14%, while cost of sales as a percentage of net product sales and stand-ready manufacturing revenue for the nine months ended September 30, 2026 decreased by eight percentage points compared to the same period in 2025. The increase in cost of sales was primarily due to higher product sales volume, partially offset by lower inventory write-downs and the absence of losses on firm purchase commitments recorded in the prior year. The decrease in cost of sales as a percentage of net product sales and stand-ready manufacturing revenue primarily reflected sales growth outpacing the increase in underlying cost of sales.
In 2026, we anticipate a modest decrease in cost of sales compared to 2025, reflecting continued manufacturing productivity improvements and operational efficiencies. This expectation excludes the impact of the settlement with Arbutus and Genevant, for which we recorded $884 million in cost of sales during the first half of 2026 and expect additional amortization expense in the remainder of the year. Excluding this impact, to the extent net product sales increase, cost of sales as a percentage of net product sales and stand-ready revenue will decrease moderately.
Research and development expenses
Research and development expenses decreased by $218 million, or 27%, for the three months ended September 30, 2026, compared to the same period in 2025. This reduction was primarily due to lower clinical trial expenses of $127 million, including a $33 million benefit recognized under the Blackstone research and development funding arrangement resulting from a revision to prior-period estimates, and lower personnel-related costs and stock-based compensation of $75 million. For the nine months ended September 30, 2026, research and development expenses decreased by $474 million, or 20%, compared to the same period in 2025. This decrease primarily reflected lower clinical trial expenses of $246 million, personnel-related costs and stock-based compensation of $152 million, and outside services of $58 million. The lower clinical trial expenses for both periods were primarily driven by reduced spending on several late-stage studies, including those related to our flu plus COVID combination vaccine, congenital CMV, RSV and norovirus programs. For the nine-month period, these reductions were partially offset by higher spending on oncology programs and COVID postmarketing commitments. The decrease in personnel-related costs and stock-based compensation for both periods primarily reflected portfolio reprioritization and associated resource realignment.
We anticipate a reduction in research and development expenses in 2026 compared to 2025, primarily driven by the wind-down of several late-stage programs, continued disciplined cost management, and a focused approach to pipeline execution. We remain committed to advancing our pipeline and late-stage programs, including our oncology and rare disease programs, while continuing to manage research and development investment levels in line with our long-term objectives.
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Selling, general and administrative expenses
Selling, general and administrative expenses increased by $14 million, or 5%, for the three months ended September 30, 2026, compared to the same period in 2025. The increase was primarily due to higher legal expenses, partially offset by reduced commercial and marketing-related spending, lower employee-related costs and other operating expenses. For the nine months ended September 30, 2026, selling, general and administrative expenses decreased by $39 million, or 5%, compared to the same period in 2025. This decrease for the nine-month period primarily driven by lower employee-related costs of $27 million, reduced commercial and marketing-related spending of $24 million, and lower other operating expenses, partially offset by higher legal expense. The reduction in commercial and marketing-related spending and other operating expenses reflected continued cost discipline and efficiencies across the organization.
We expect selling, general and administrative expenses in 2026 to remain at a level relatively consistent with 2025, reflecting an efficient and scalable operating structure. While we will continue to make selective investments to support our key priorities, including our global commercial and regulatory activities, we expect these investments to be largely offset by ongoing efficiency initiatives and disciplined resource allocation.
Interest income
For the three months ended September 30, 2026, interest income decreased by $11 million, or 15%, compared to the same period in 2025. For the nine months ended September 30, 2026, interest income decreased by $43 million, or 18%, compared to the same period in 2025. The decrease in each period was primarily due to lower average investment balances and interest rates.
Other (expense) income, net
The following tables summarize other expense, net for the periods presented (in millions):
| Three Months Ended September 30, | Change 2026 vs. 2025 | ||||||||||||||||||||||
| 2026 | 2025 | $ | % | ||||||||||||||||||||
| (Loss) gain on investments | $ | (1) | $ | 4 | $ | (5) | (125)% | ||||||||||||||||
| Interest expense | $ | (18) | $ | — | $ | (18) | 100% | ||||||||||||||||
| Other expense, net | (2) | (4) | 2 | (50)% | |||||||||||||||||||
| Total other (expense) income, net | $ | (21) | $ | — | $ | (21) | (100)% | ||||||||||||||||
| Nine Months Ended September 30, | Change 2026 vs. 2025 | ||||||||||||||||||||||
| 2026 | 2025 | $ | % | ||||||||||||||||||||
| Loss on investments | $ | (2) | $ | (3) | $ | 1 | (33)% | ||||||||||||||||
| Interest expense | (52) | (2) | (50) | 2,500% | |||||||||||||||||||
| Other (expense) income, net | (4) | 9 | (13) | (144)% | |||||||||||||||||||
| Total other (expense) income, net | $ | (58) | $ | 4 | $ | (62) | (1,550)% | ||||||||||||||||
For the three and nine months ended September 30, 2026, we recorded total other expense, net of $21 million and $58 million, respectively, compared to total other income, net of an immaterial amount and $4 million for the same periods in 2025. The increase in other expense, net for the three and nine months ended September 30, 2026, was largely driven by higher interest expense. Interest expense is primarily related to our term loan issued in November 2025, our convertible notes issued in September 2026, and finance leases related to certain contract manufacturing service agreements. Please refer to Note 10 and Note 11 to our condensed consolidated financial statements for additional information.
Income taxes
Provision for income taxes was $9 million and $33 million for the three and nine months ended September 30, 2026, respectively, compared to $13 million and $27 million for the same periods in 2025. The provision primarily resulted from taxable income generated by certain of our foreign subsidiaries. The effective tax rate continues to reflect the maintenance of our global valuation allowance, which limits our ability to recognize tax benefits associated with our expected full-year loss. Please refer to Note 14 to our condensed consolidated financial statements for additional details.
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Liquidity and capital resources
The following table summarizes our cash, cash equivalents, investments and working capital as of September 30, 2026 and December 31, 2025 (in millions):
| September 30, | December 31, | |||||||||||||
| 2026 | 2025 | |||||||||||||
| Financial assets: | ||||||||||||||
| Cash and cash equivalents | $ | 1,195 | $ | 2,595 | ||||||||||
| Investments | 3,976 | 3,204 | ||||||||||||
| Investments, non-current | 2,805 | 2,336 | ||||||||||||
| Total | $ | 7,976 | $ | 8,135 | ||||||||||
| Working capital: | ||||||||||||||
| Current assets | $ | 7,344 | $ | 6,544 | ||||||||||
| Current liabilities | 2,028 | 1,987 | ||||||||||||
| Total | $ | 5,316 | $ | 4,557 | ||||||||||
Our cash, cash equivalents and investments are invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation. Investments, consisting primarily of government and corporate debt securities, are stated at fair value. Cash, cash equivalents and investments as of September 30, 2026 decreased by $159 million, or 2%, compared to December 31, 2025. The decrease in cash, cash equivalents and investments was primarily due to a net cash outflow from operating activities of $2.7 billion, partly offset by net proceeds of $2.6 billion from the issuance of convertible notes, after payments for the related capped call transactions, during the nine months ended September 30, 2026.
Working capital, defined as current assets less current liabilities, increased by $759 million, or 17%, as of September 30, 2026, compared to December 31, 2025. This was primarily driven by an increase in accounts receivable, net of $1.2 billion, driven by product sales in the quarter, partly offset by a decrease in cash, cash equivalents and current investments of $628 million to fund operations.
As of September 30, 2026, we did not have any off-balance sheet arrangements. For a discussion of our contractual obligations and commitments, refer to our 2025 Form 10-K.
Cash flow
The following table summarizes the primary sources and uses of cash for each period presented (in millions):
| Nine Months Ended September 30, | |||||||||||
| 2026 | 2025 | ||||||||||
Net cash (used in) provided by: | |||||||||||
Operating activities | $ | (2,715) | $ | (2,803) | |||||||
Investing activities | (1,462) | 1,994 | |||||||||
Financing activities | 2,776 | 12 | |||||||||
Operating activities
We derive cash flows from operations primarily from cash collected from customer advance payments and accounts receivable related to our product sales, as well as other revenue and funding arrangements. Our cash flows from operating activities are significantly affected by our use of cash for operating expenses and working capital to support the business. We sell our vaccines to the commercial market as well as to governments and international organizations. Certain supply agreements include upfront payments, which are initially recorded as deferred revenue. In the U.S., our vaccines are sold primarily to wholesalers and distributors, and to a lesser extent, directly to retailers, healthcare providers and government entities. Wholesalers and distributors typically do not make upfront payments to us. In addition, we receive customer advance payments related to certain other revenue arrangements. As of September 30, 2026, we had $407 million in deferred revenue related to customer advance payments received or billable.
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Net cash used in operating activities for the nine months ended September 30, 2026 was $2.7 billion and consisted of net loss of $2.0 billion, non-cash adjustments of $527 million, and a net change in assets and liabilities of $1.3 billion. Non-cash items primarily included stock-based compensation of $351 million and depreciation and amortization of $190 million. The net change in assets and liabilities was mainly due to an increase in accounts receivable, net of $1.2 billion, driven by sales in the quarter and timing of collections, and an increase in inventory of $159 million driven by increased production for the 2026/2027 respiratory season, partially offset by an increase in deferred revenue of $160 million driven by customer advance payments.
Net cash used in operating activities decreased by $88 million, or 3%, during the nine months ended September 30, 2026, compared to the same period in 2025, primarily attributable to a change in accrued liabilities and accounts payable of $313 million as the reduction in spending was less pronounced than in the prior year, together with favorable changes in inventory, prepaid expenses and other assets, deferred revenue and other liabilities, primarily due to timing of purchases, payments and customer advances. These changes were partially offset by an increase in accounts receivable, net of $481 million driven by higher product sales.
Investing activities
Our primary investing activities consist of purchases, sales, and maturities of our investments, capital expenditures for facilities, manufacturing and laboratory equipment, and computer equipment and software, as well as business development activities.
Net cash used in investing activities for the nine months ended September 30, 2026 was $1.5 billion, driven primarily by purchases of marketable securities of $5.1 billion, and purchases of property and equipment of $146 million, partially offset by proceeds from maturities and sales of marketable securities of $3.9 billion.
Net investing cash flows decreased by $3.5 billion, or 173%, during the nine months ended September 30, 2026, compared to the same period in 2025, primarily due to a decrease in proceeds from maturities and sales of marketable securities of $2.5 billion and an increase in purchases of marketable securities of $928 million.
Financing activities
Net cash provided by financing activities for the nine months ended September 30, 2026 was $2.8 billion, primarily related to net proceeds from the issuance of convertible notes of $2.6 billion, after payments for the related capped call transactions.
Net cash provided by financing activities increased by $2.8 billion, during the nine months ended September 30, 2026, compared to the same period in 2025, mainly due to net proceeds of $2.6 billion from the issuance of convertible notes, after payments for the related capped call transactions, and an increase in proceeds from issuance of common stock through equity plans of $153 million.
Operation and funding requirements
Our principal sources of funding as of September 30, 2026 consisted of cash and cash equivalents, investments, and cash we may generate from operations. We reported a net loss of $2.0 billion for the nine months ended September 30, 2026 and net losses of $2.8 billion and $3.6 billion for the years 2025 and 2024, respectively. Historically, from our inception to the end of 2020, we incurred significant losses from operations due to our significant research and development expenses. Following the authorization of our first commercial product in December 2020, we generated significant net income in both 2022 and 2021. We have retained earnings of $5.3 billion as of September 30, 2026.
We have significant future capital requirements including expected operating expenses to conduct research and development activities, operate our organization, and meet capital expenditure needs. We anticipate maintaining substantial expenses across all areas of our ongoing activities, particularly as we continue research and development of our development candidates and clinical activities for our investigational medicines. This also extends to our manufacturing costs, including our arrangements with our supply and manufacturing partners. Our ongoing work on intismeran autogene, our other oncology programs, norovirus, development of any new COVID vaccines against variants of SARS-CoV-2, late-stage clinical development, investments in digital capabilities and artificial intelligence technologies, and buildout of global commercial, regulatory, sales and marketing infrastructure and manufacturing facilities will require significant cash outflows in future periods, most of which will not be reimbursed or otherwise paid for by our collaborators or alliances. We are also incurring, and expect to continue to incur, costs related to postmarketing requirements and commitments for certain approved products, including ongoing clinical and safety studies. The scope, timing and duration of these activities remain subject to regulatory requirements and may evolve over time. In addition, we have substantial facility, lease and purchase obligations. We have entered into various collaboration and licensing agreements, as well as research and development funding arrangements with third parties. These arrangements collectively encompass the funding of specific research and development activities, with the distinction that under the research and development funding arrangement, we receive funding. However, for all these arrangements, we may be obligated to make potential future milestone and royalty payments.
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In November 2025, we entered into a Credit and Guaranty Agreement (Credit Agreement) with lenders led by Ares Capital Corporation, as administrative agent, providing for a term loan facility with aggregate commitments of $1.5 billion. As of September 30, 2026, we had drawn $600 million under the initial term loan. The Credit Agreement also provides for $900 million of delayed draw term loan commitments, consisting of $400 million available, subject to applicable conditions, through November 2027 and $500 million available, subject to applicable conditions and specified regulatory approval milestones, through November 2028. Borrowings under the Credit Agreement bear interest at a variable rate based on Term SOFR or a base rate, at our option, plus an applicable margin, with interest payable periodically and the principal amount due in full at maturity in November 2030. The Credit Agreement includes customary affirmative and negative covenants, with which we were in compliance as of September 30, 2026. See Note 11 to our condensed consolidated financial statements for additional information.
In September 2026, we issued $3.0 billion aggregate principal amount of 0.00% Convertible Senior Notes due 2032 (the 2032 Notes). We received net proceeds of approximately $3.0 billion from the issuance of the 2032 Notes, and used $329 million of the proceeds to fund related capped call transactions. The 2032 Notes have a zero-coupon interest rate and therefore do not require periodic cash interest payments. Upon conversion, we may elect to settle the 2032 Notes in cash, shares of our common stock, or a combination of cash and shares. We may, however, be required to make cash payments in connection with a redemption or repurchase of the 2032 Notes under certain circumstances. Unless earlier converted, redeemed or repurchased, the $3.0 billion principal amount of the 2032 Notes is payable at maturity in March 2032. See Note 11 to our condensed consolidated financial statements for additional information.
We believe that our cash, cash equivalents, and investments as of September 30, 2026, together with cash expected to be generated from product sales and available borrowings under our credit facility, will be sufficient to enable us to fund our projected operations and capital expenditures through at least the next 12 months from the issuance of these financial statements included in this Form 10-Q. We are subject to all the risks related to the development and commercialization of novel medicines, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors, which may adversely affect our business. For example, we experienced a decline in customer demand for our COVID vaccine in 2023 and 2024, and this trend continued in 2025 as the market transitions to a more competitive and commercially driven environment, with broader external factors continuing to affect market dynamics. We foresee that our commitment to investing in our business for future product launches may lead to continued negative cash flows from operations in upcoming periods. Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect.
Critical accounting policies and significant judgments and estimates
There have been no material changes in our critical accounting policies and estimates in the preparation of our condensed consolidated financial statements during the three months ended September 30, 2026 compared to those disclosed in our 2025 Form 10-K.
Contractual Obligations
As of September 30, 2026, there have been no material changes to our contractual obligations and commitments from those described under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our 2025 Form 10-K.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Our market risks, and the way we manage them, are summarized in Part II, Item 7A., “Quantitative and Qualitative Disclosures About Market Risk” of our 2025 Form 10-K. There have been no material changes to our market risk or to our management of such risks for the three and nine months ended September 30, 2026.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2026. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s
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management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of September 30, 2026, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the three months ended September 30, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Inherent Limitations on Effectiveness of Controls
Our management, including our Chief Executive Officer and Chief Financial Officer, believes that our disclosure controls and procedures and internal control over financial reporting are designed to provide reasonable assurance of achieving their objectives and are effective at the reasonable assurance level. However, our management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent all errors and all fraud. A control system, no matter how well-conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by the collusion of two or more people or by a management override of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
PART II
Item 1. Legal Proceedings
We are involved in various claims and legal proceedings of a nature considered ordinary course in our business, including those described under the heading “Legal Proceedings” in our 2025 Form 10-K and our Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2026 and June 30, 2026. Most of the issues raised by these claims are highly complex and subject to substantial uncertainties. For a description of risks relating to these and other legal proceedings we face, see Part I, Item 1A., “Risk Factors,” of our 2025 Form 10-K, including the discussion under the headings entitled “Risks related to our intellectual property” and “Risks related to the manufacturing of our commercial products and product candidates.” The outcome of any such proceedings, regardless of the merits, is inherently uncertain; therefore, assessing the likelihood of loss and any estimated damages is difficult and subject to considerable judgment.
GSK Patent Litigation
We and GSK Biologicals S.A. (GSK) entered into an agreement on October 28, 2026, to settle all disputes between the parties which were pending in the U.S. and Europe. Pursuant to the agreement, the parties granted patent cross-licenses in the field of infectious disease and are not obligated to make payments of any kind in connection with such licenses.
Pfizer/BioNTech Patent Litigation
As more fully described in our 2025 Form 10-K, we brought patent infringement actions against Pfizer Inc. (Pfizer), BioNTech SE (BioNTech) and related entities in Germany, the Netherlands, the UK, Ireland and Belgium concerning our mRNA platform technology and disease-specific vaccine designs. In September 2026, the Technical Board of Appeal of the European Patent Office revoked our European Patent No. 3 590 949 in all contracting states, including Germany, the Netherlands, the UK, Ireland and Belgium. Following this decision, the related national proceedings in Belgium, Ireland and the Netherlands have been dismissed. Proceedings in Germany and the UK remain pending awaiting the written decision of the Technical Board of Appeal.
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In September 2026, we filed a complaint against Pfizer, BioNTech, and certain of their affiliates in the Hamburg Local Division of the Unified Patent Court (UPC) asserting our European Patent No. 3 981 437 to modified mRNA vaccines formulated in lipid nanoparticles. The complaint seeks a judgment of infringement of the asserted patent and unspecified damages.
CureVac Patent Litigation
In April 2026, CureVac Manufacturing GmbH filed a complaint against Moderna, Inc., ModernaTX, Inc., and certain of our affiliates in the Hague Local Division of the UPC asserting European Patent No. EP 4 108 769 related to mRNA production and purification methods. The complaint seeks a judgment of infringement of the asserted patent and unspecified damages.
In August 2026, CureVac SE filed a complaint against Moderna Biotech Spain S.L., Moderna Switzerland GmbH, Moderna Netherlands B.V., ModernaTX, Inc., Rovi Pharma Industrial Services S.A., and Recipharm Monts SAS in Commercial Court No. 5 of Barcelona, Spain, asserting European Patent No. 1 857 122 (EP’122) related to mRNA compositions with increased guanine and cytosine content. The complaint seeks a judgment of infringement of the asserted patent and unspecified damages.
In October 2026, CureVac SE filed a complaint against Moderna Switzerland GmbH, ModernaTX, Inc., Lonza AG, and Lonza Sales AG in the Swiss Federal Patent Court asserting EP’122 related to mRNA compositions with increased guanine and cytosine content. The complaint seeks a judgment of infringement of the asserted patent and unspecified damages.
Securities Class Action Litigation
As more fully described in our 2025 Form 10-K, in August 2024, a putative securities class action complaint was filed against Moderna and certain of its officers in the U.S. District Court for the District of Massachusetts. On October 8, 2026, the court issued a Memorandum & Order granting Moderna’s motion to dismiss. On October 13, 2026, the court entered an Order of Dismissal dismissing the action with prejudice. The decision is subject to appeal.
Item 1A. Risk Factors
Information regarding risk and uncertainties related to our business appears in Part I, Item 1A. “Risk Factors” of our 2025 Form 10-K. There have been no material changes from the risk factors previously disclosed in the 2025 Form 10-K other than set forth below.
Risks related to our convertible notes
Servicing our debt requires a significant amount of cash, and we may not have sufficient cash flow from our business to pay our substantial debt.
Our ability to make repayments of the principal of, to pay interest, if any, on or to refinance our indebtedness, including our outstanding 0.00% Convertible Senior Notes due 2032 (the notes), and to pay any cash amounts upon conversion of the notes, depends on our future performance, which is subject to economic, financial, competitive and other factors beyond our control. Our business may not generate cash flow from operations in the future sufficient to service our debt and make necessary capital expenditures. If we are unable to generate such cash flow, we may be required to adopt one or more alternatives, such as selling assets, restructuring debt or obtaining additional debt or equity capital on terms that may be onerous or highly dilutive. Our ability to refinance our indebtedness will depend on the capital markets and our financial condition at such time. We may not be able to engage in any of these activities or engage in these activities on desirable terms, which could result in a default on our debt obligations.
We may not have the ability to raise the funds necessary to settle conversions of the notes in cash, to repay the notes at maturity or to repurchase the notes upon a fundamental change, and our future debt may contain limitations on our ability to pay cash upon conversion or repurchase of the notes.
Holders of the notes have the right, subject to certain conditions, to require us to repurchase all or any portion of their notes upon the occurrence of a fundamental change (as defined in the indenture governing the notes) at a fundamental change repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid special interest, if any, to, but excluding, the fundamental change repurchase date. Upon maturity of the notes, we must pay the principal amount of the notes plus accrued and unpaid special interest, if any, in cash, unless the notes have been previously repurchased, redeemed or converted. In addition, upon conversion of the notes, unless we elect to issue solely shares of common stock to settle conversions (other than paying cash in lieu of delivering any fractional share), we will be required to make cash payments in respect of such conversions. However, we may not have enough available cash or be able to obtain financing upon maturity of the notes or at the time we are required to make repurchases of any notes surrendered therefor or pay cash with respect to notes being converted. In addition, our credit and guaranty agreement restricts, and our future debt may prohibit us from making any cash payments on the conversion or repurchase of the notes or making any cash payments upon a fundamental change. Our ability to repurchase the notes or to pay cash upon conversions or at maturity of the notes may also be limited by law or by regulatory authority. Our failure to repurchase notes at a time when the repurchase is required by the indenture governing the notes or to pay any cash payable on future conversions or at maturity of the
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notes as required by the indenture governing the notes would constitute a default under the indenture governing the notes. A default under the indenture governing the notes or the fundamental change itself could also lead to a default under agreements governing our future indebtedness. If the repayment of the related indebtedness were to be accelerated after any applicable notice or grace periods, we may not have sufficient funds to repay the indebtedness and repurchase the notes or make cash payments upon conversions thereof.
The conditional conversion feature of the notes, if triggered, may adversely affect our financial condition and operating results.
In the event the conditional conversion feature of the notes is triggered, holders of notes will be entitled to convert their notes at any time during specified periods at their option. If one or more holders elect to convert their notes, unless we elect to satisfy our conversion obligation by delivering solely shares of common stock (other than paying cash in lieu of delivering any fractional share) we would be required to settle a portion or all of our conversion obligation through the payment of cash, which could adversely affect our liquidity. In addition, even if holders do not elect to convert their notes, we would be required under applicable accounting rules to reclassify all or any portion of the outstanding principal of the notes as a current rather than long-term liability, which would result in a material reduction of our net working capital.
Conversion of the notes may dilute the ownership interest of our stockholders or may otherwise depress the price of our common stock.
The conversion of some or all of the notes may dilute the ownership interests of our stockholders. Upon conversion of the notes, we have the option to pay or deliver, as the case may be, cash, shares of our common stock, or a combination of cash and shares of our common stock in respect of our conversion obligation. If we elect to settle our conversion obligation in shares of common stock or a combination of cash and shares of common stock, any sales in the public market of our common stock issuable upon such conversion could adversely affect prevailing market prices of our common stock. In addition, the existence of the notes may encourage short selling by market participants because the conversion of the notes could be used to satisfy short positions, or anticipated conversion of the notes into shares of our common stock could depress the price of our common stock.
The accounting method for the notes could adversely affect our reported financial condition and results.
The accounting method for reflecting the notes on our balance sheet, accruing interest expense for the notes and reflecting the underlying shares of our common stock in our reported diluted earnings per share may adversely affect our reported earnings and financial condition.
The notes are reflected as a liability on our balance sheets, with the initial carrying amount equal to the principal amount of the notes, net of issuance costs. The issuance costs were treated as a debt discount for accounting purposes, which is being amortized into interest expense over the term of the notes. As a result of this amortization, the interest expense that we expect to recognize for the notes for accounting purposes will be greater than the cash interest payments we will pay on the notes, which will result in lower reported net income or larger reported loss.
In addition, the shares of common stock underlying the notes are reflected in our diluted earnings per share using the “if converted” method. Under that method, diluted earnings per share is generally calculated assuming that all the notes were converted solely into shares of common stock at the beginning of the reporting period unless the result would be anti-dilutive. The application of the if-converted method may reduce our reported diluted earnings per share to the extent we are profitable in the future, and accounting standards may change in the future in a manner that may adversely affect our diluted earnings per share.
In addition, accounting standards may change in the future. Further, if in the future we irrevocably elect a settlement method to apply to conversions of notes, the accounting treatment for the notes could be different than described above. Accordingly, we may account for the notes in a manner that is significantly different than described above.
Certain provisions in the indenture governing the notes may delay or prevent an attempted takeover of us that might be financially advantageous to the shareholders.
Certain provisions in the indenture governing the notes may make it more difficult or expensive for a third party to acquire us. For example, the indenture governing the notes will require us, except as provided therein, to repurchase the notes for cash upon the occurrence of a fundamental change and, in certain circumstances, to increase the conversion rate for a holder that converts its notes in connection with a make-whole fundamental change. A takeover of us may trigger the requirement that we repurchase the notes and/or increase the conversion rate, which could make it costlier for a potential acquirer to engage in such takeover. Such additional costs may have the effect of delaying or preventing a takeover of us that would otherwise be beneficial to investors.
The capped call transactions may affect the market price of our common stock.
In connection with the offering of the notes, we entered into privately negotiated capped call transactions with certain financial institutions (the option counterparties). The capped call transactions cover, subject to customary adjustments, the number of shares of
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our common stock that initially underlie the notes. The capped call transactions are expected generally to reduce the potential dilution to our common stock upon any conversion of notes and/or offset any cash payments we are required to make in excess of the principal amount of converted notes, as the case may be, with such reduction and/or offset subject to a cap.
We expect that the option counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to our common stock and/or purchasing or selling our common stock or other securities of ours in secondary market transactions prior to the maturity of the notes (and are likely to do so following any early conversion, repurchase, or redemption of the notes, to the extent we unwind a corresponding portion of the capped call transactions, or if we otherwise unwind all or a portion of the capped call transactions, and during the final observation period for the conversion of notes). This activity could also cause or avoid an increase or a decrease in the market price of our common stock.
The potential effect, if any, of these transactions and activities on the market price of the common stock will depend in part on market conditions. Any of these activities could adversely affect the value of the common stock.
We cannot predict the direction or magnitude of any potential effect that the transactions described above may have on the price of our common stock.
We are subject to counterparty risk with respect to the capped call transactions.
The option counterparties are financial institutions, and we are subject to the risk that one or more of the option counterparties may default or otherwise fail to perform, or may exercise certain rights to terminate, their obligations under the capped call transactions. Our exposure to the credit risk of the option counterparties is not secured by any collateral.
Global economic conditions have from time to time resulted in the actual or perceived failure or financial difficulties of many financial institutions and could adversely affect the option counterparties’ performance under the capped call transactions. If an option counterparty becomes subject to insolvency proceedings, we will become an unsecured creditor in those proceedings with a claim equal to our exposure at that time under the capped call transaction with such option counterparty. Our exposure will depend on many factors but, generally, our exposure will increase if the market price or the volatility of our common stock increases. In addition, upon a default or other failure to perform, or a termination of obligations, by an option counterparty, we may suffer more dilution than we currently anticipate with respect to our common stock.
In addition, the terms of the capped call transactions may be subject to adjustment, modification or, in some cases, renegotiation in the event of certain corporate and other transactions. The capped call transactions may not operate as we intend in the event that we are required to adjust the terms of such instruments as a result of transactions in the future or in the event of other unanticipated developments that may adversely affect the functioning of the capped call transactions.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Issuer Purchases of Equity Securities
On August 1, 2022, our Board of Directors authorized a share repurchase program for our common stock of up to $3.0 billion, with no expiration date. During the three months ended September 30, 2026, there were no shares repurchased. As of September 30, 2026, $1.7 billion of our Board of Directors’ authorization for repurchases of our common stock remains outstanding, with no expiration date.
For details about our share repurchase programs, please refer to Note 12 to our consolidated financial statements, as set forth in our 2025 Form 10-K.
Item 5. Other Information
None of our directors or officers (as defined in Rule 16a-1(f) of the Securities Exchange Act of 1934, as amended) adopted terminated
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Item 6. Exhibits
The Exhibits listed below are filed or incorporated by reference as part of this Form 10-Q.
| Exhibit No. | Exhibit Index | |||||||
| 4.1 | Indenture, dated as of September 1, 2026, by and between Moderna, Inc. and U.S. Bank Trust Company, National Association, as Trustee (incorporated by reference to the Current Report on Form 8-K (File No. 001-38753) filed with the Securities and Exchange Commission on September 1, 2026) | |||||||
| 4.2 | Form or Global Note, representing Moderna, Inc.’s 0.00% Convertible Senior Notes due 2032 (included as Exhibit A to the Indenture filed as Exhibit 4.1) | |||||||
| 10.1 | Form of Confirmation for Capped Call Transactions (incorporated by reference to the Current Report on Form 8-K (File No. 001-38753) filed with the Securities and Exchange Commission on September 1, 2026) | |||||||
| 31.1* | Certification of Principal Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | |||||||
| 31.2* | Certification of Principal Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | |||||||
| 32.1+ | Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | |||||||
| 101.INS* | XBRL Instance Document - The instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document | |||||||
| 101.SCH* | XBRL Taxonomy Extension Schema Document | |||||||
| 101.CAL* | XBRL Taxonomy Extension Calculation Document | |||||||
| 101.DEF* | XBRL Taxonomy Extension Definition Linkbase Document | |||||||
| 101.LAB* | XBRL Taxonomy Extension Label Linkbase Document | |||||||
| 101.PRE* | XBRL Taxonomy Extension Presentation Link Document | |||||||
| 104* | Cover Page Interactive Data File (formatted as Inline XBRL with applicable taxonomy extension information contained in Exhibits 101.) | |||||||
| * | Filed herewith | ||||
| + | The certification furnished in Exhibit 32.1 hereto is deemed to accompany this Form 10-Q and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. Such certification will not be deemed to be incorporated by reference into any filings under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except to the extent that the Registrant specifically incorporates it by reference. | ||||
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SIGNATURES
Pursuant to the requirements of the Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
MODERNA, INC. | |||||||||||
| Date: | By: | /s/ Stéphane Bancel | |||||||||
| November 6, 2026 | |||||||||||
| Stéphane Bancel | |||||||||||
| Chief Executive Officer and Director | |||||||||||
(Principal Executive Officer) | |||||||||||
| Date: | By: | /s/ James M. Mock | |||||||||
| November 6, 2026 | |||||||||||
| James M. Mock | |||||||||||
| Chief Financial Officer | |||||||||||
(Principal Financial Officer) | |||||||||||
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