Sanofi SEC Filings

Sanofi reported first-half 2026 net sales of €22,106 million, up from €19,889 million a year earlier, with strong contributions including Dupixent net sales of €9,324 million. Total net income was €1,997 million versus €5,837 million, reflecting lower discontinued-operation gains and higher charges.

Results were weighed by €1,031 million of intangible asset impairments, mainly a €952 million write-down of amlitelimab, and a higher effective tax rate of 30.6%. Operating cash flow rose to €4,643 million, while a cash tender offer for Dynavax (purchase price €1,571 million, net outflow €1,403 million), dividends of €4,923 million and share buybacks of €1,003 million contributed to an increase in net debt to €15,513 million from €11,008 million. Sanofi also classified its Brazilian generics unit Medley as held for sale, expecting a net gain on closing, subject to regulatory clearance.

Sanofi reported Q2 2026 net sales of €11,597 million, up 17.8% at constant exchange rates and 16.0% at actual rates. Business EPS was €2.09, up 33.3% at constant exchange rates, driven by strong growth in pharma launches (€1,305 million, +48.3%) and Dupixent (€5,154 million, +37.6%). Vaccines declined 4.7% to €1,150 million. IFRS EPS was €0.29, down 91.0%, including an impairment expense of €1,031 million, mainly €952 million related to the amlitelimab intangible asset.

Business operating income reached €3,291 million, up 35.8% at constant exchange rates, with a margin of 28.4%. H1 2026 free cash flow was €3,724 million, up 51.5%. A €1 billion share buyback was completed and the 2025 dividend of €4.12 per share was approved. Net debt rose to €15,513 million from €10,988 million as of January 1, 2026, reflecting the Dynavax acquisition, dividends and the buyback.

The company recorded seven regulatory approvals across immunology, rare diseases, oncology and neurology, including new indications or formulations for Dupixent, Tzield, Wayrilz, Sarclisa and Cenrifki, plus multiple priority and fast-track designations. Strategic pipeline decisions led to discontinuation of amlitelimab, itepekimab and balinatunfib programmes. The Impact medicines portfolio now reaches 30 underserved countries, and the Global Health Unit has treated 195,263 non-communicable disease patients cumulatively since 2022.

Sanofi, as an institutional investment manager, reports its quarterly equity holdings under Form 13F. The report is filed as a 13F Holdings Report, meaning all of Sanofi’s reportable U.S.-listed positions are included in this submission.

The filing lists 10 reportable positions in the Form 13F Information Table, with an aggregate reported value of $534,041,662 (rounded to the nearest dollar). No other investment managers are included, and Sanofi’s Head of Legal Corporate & Finance, Alexandra Roger, signs on behalf of the reporting manager.

Sanofi reported two July 2026 updates. One outlines an evolution of the Executive Committee effective September 1, 2026, with leadership changes across regional roles and global functions. Madeleine Roach will become President and Country Lead for Germany, Switzerland and Austria, with her current business operations responsibilities folded into Finance, whose remit will expand to include Global Partnering and Business Development. Thomas Triomphe will add responsibility for China alongside Vaccines leadership, while Olivier Charmeil moves to Strategic Projects Advisor to the CEO and Roy Papatheodorou, Executive Vice President and General Counsel, will leave after over four years.

The other update announces discontinuation of clinical development of amlitelimab in moderate-to-severe atopic dermatitis and a decision not to submit the drug for global regulatory reviews, after determining that the totality of efficacy and safety evidence would not deliver a meaningful improvement over current standard of care. Ongoing atopic dermatitis studies will be wound down with patient transition plans, but a phase 2 study of amlitelimab in celiac disease continues, with results expected in the second half of 2026. Sanofi is not changing its full-year 2026 guidance following this decision.

Amundi and its subsidiary Amundi Asset Management report beneficial ownership of 68,651,904 Sanofi common shares, representing 5.65% of the class. They report no sole voting or dispositive power, but shared voting power over 36,655,093 shares and shared dispositive power over the full 68,651,904 shares.

Within this position, 28,906,920 shares are held through a French employee investment vehicle (FCPE) dedicated to Sanofi employees. Voting rights for these FCPE shares are exercised by the FCPE’s supervisory board, where employee representatives hold the majority, and not by Amundi.

Sanofi reports that the US FDA has approved subcutaneous Sarclisa Escena (isatuximab-irfc) for multiple myeloma in combination with standard regimens across all existing Sarclisa IV indications. Sarclisa Escena becomes the first anticancer treatment administered via an on-body injector or manual subcutaneous injection.

The pivotal IRAKLIA phase 3 non-inferiority study showed Sarclisa Escena delivered by on-body injector achieved a 71.1% objective response rate versus 70.5% with IV Sarclisa, with a similar overall safety profile but markedly fewer systemic administration reactions, 1.5% versus 25%. Injection site reactions occurred in 0.4% of 5,145 on-body injections, nearly all mild. Sarclisa Escena is given as a fixed 1,400 mg subcutaneous dose and Sarclisa-based regimens have treated more than 70,000 patients worldwide, with approvals in almost 60 countries across several multiple myeloma indications.

Sanofi reported positive phase 3 results from its Baby-COMET study of Nexviazyme (avalglucosidase alfa) in infants with infantile-onset Pompe disease (IOPD). The trial met its primary endpoint, with treatment-naïve participants six months and younger alive and free of invasive ventilation at 52 weeks of treatment.

The study also met all secondary endpoints, including ventilator-free survival at 12 and 18 months of age and numerical improvements in cardiac and motor function measures at 52 weeks. Nexviazyme was well tolerated, with no serious treatment-related adverse events and manageable infusion reactions. The data will support a planned U.S. regulatory submission for a label extension in the second half of 2026.

Sanofi filed a Form 6-K summarizing several June 2026 milestones. Japan approved a subcutaneous formulation of Sarclisa for multiple myeloma, including use with standard regimens and potential future administration via an on-body injector, supported by the phase 3 IRAKLIA study showing non-inferior efficacy versus intravenous dosing.

The European Commission approved Cenrifki for adults with secondary progressive multiple sclerosis without recent relapses, based on the HERCULES and GEMINI phase 3 programs, with drug-induced liver injury identified as a key safety risk requiring liver monitoring. Japan also authorized Wayrilz for persistent or chronic immune thrombocytopenia after the LUNA 3 phase 3 study met primary and secondary endpoints.

Separately, Sanofi appointed Paulo Fontoura as Executive Vice President and Global Head of R&D Pharma, effective September 1, 2026, adding an experienced R&D leader to its executive committee.

Sanofi reports that the US FDA has granted accelerated approval to Tzield (teplizumab-mzwv) to delay the decline of natural insulin production in children aged eight to 17 years recently diagnosed with stage 3 type 1 diabetes. This makes Tzield the first disease-modifying therapy for autoimmune type 1 diabetes in this setting.

The decision is based on the phase 3 PROTECT study, where Tzield significantly slowed the decrease in C-peptide, a marker of beta cell function, compared with placebo, and on data from more than 900 treated patients. Approval is conditional on confirmation of clinical benefit in the ongoing BETA-PRESERVE phase 3 study.