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Sanofi reported strong 2025 growth with a rich pipeline and active capital return. Net sales reached €43,626 million, up 9.9% at constant exchange rates, led by Dupixent (€15,714 million, +25.2%) and new pharma launches (€3,911 million, +47.9%). Business EPS rose to €7.83, up 15.0% at constant exchange rates, while free cash flow was €8,089 million.
In Q4 2025, sales were €11,303 million (+13.3% at constant exchange rates) and business EPS was €1.53 (+26.7% at constant exchange rates), showing margin expansion from a shift toward specialty medicines. IFRS EPS was -€0.66 in the quarter, mainly reflecting large intangible impairments including tolebrutinib.
Sanofi completed a €5 billion share buyback and proposes a €4.12 dividend for 2025, its 31st consecutive increase, and plans a €1 billion buyback in 2026. It closed the $1.2 billion Vicebio acquisition, agreed to acquire Dynavax for about $2.2 billion, and generated €10.4 billion net cash from the Opella consumer health separation. For 2026, Sanofi expects sales to grow by a high single-digit percentage at constant exchange rates with business EPS growing slightly faster, and sees profitable growth continuing for at least five years.
Sanofi reported new late-stage clinical results for amlitelimab, an experimental antibody targeting OX40-ligand for patients 12 and older with moderate-to-severe atopic dermatitis.
Two global phase 3 trials, SHORE and COAST 2, showed that amlitelimab given every four or twelve weeks improved skin clearance and disease severity at Week 24 versus placebo on key measures such as vIGA-AD 0/1 and EASI-75, with a safety profile similar to placebo in both studies. In COAST 2, amlitelimab met the primary endpoint for the US estimand but did not achieve statistical significance on co-primary endpoints for the EU estimand.
A preliminary analysis of the open-label ATLANTIS phase 2 study showed progressive improvement in vIGA-AD 0/1 from 35.4% at Week 24 to 50.3% at Week 52 and EASI-75 from 62.9% to 76.5%, with low discontinuations and serious adverse events. Sanofi plans global regulatory submissions for amlitelimab in the second half of 2026, while emphasizing that the drug remains under clinical development and is not yet approved.
Sanofi filed a report summarizing two regulatory milestones from September 2025. The company notes a press release on a positive CHMP opinion in the European Union for Dupixent, developed with Regeneron, for treating chronic spontaneous urticaria. A second press release covers an update on the U.S. regulatory review of tolebrutinib in non-relapsing, secondary progressive multiple sclerosis. The report itself mainly serves to formally furnish these press releases to investors.
Sanofi reported three corporate press developments in September 2025 affecting its late-stage pipeline. On September 10, 2025, Tzield was approved in China as the first disease-modifying therapy for adult and pediatric patients with stage 2 type 1 diabetes, marking a regulatory milestone for that indication in China. On September 11, 2025, Sanofi announced that SAR402663 received fast track designation in the U.S. for neovascular age-related macular degeneration, which can accelerate development and review. On September 17, 2025, Sanofi reported positive phase 2a results for brivekimig in hidradenitis suppurativa. The report is signed by Alexandra Roger, Head of Legal Corporate & Finance.