Sanofi FR SEC Filings

Sanofi furnished a report highlighting new clinical data and regulatory filings. A real-world study of Beyfortus (nirsevimab) in Galicia, Spain found a 94.4% coverage rate (11,796 of 12,492 infants) and an 85.9% reduction in RSV-related lower respiratory tract infection hospitalizations during the first season. Among infants immunized in their first season, hospitalizations fell 55.3% in the second RSV season, with substantial decreases in RSV-related rehospitalizations as well.

Sanofi and Teva reported phase 2b long-term extension results for duvakitug in ulcerative colitis and Crohn’s disease, showing durable clinical and endoscopic efficacy over 44 weeks in patients who initially responded to induction therapy, with both 450 mg and 900 mg doses well tolerated. Sanofi also announced it has filed its 2025 Form 20-F with the SEC and its French “Document d’Enregistrement Universel” containing the Annual Financial Report with the AMF.

Amundi and Amundi Asset Management filed an amended Schedule 13G reporting beneficial ownership of 62,741,607 Sanofi common shares and ADRs, representing 5.11% of the class. They report no sole voting or dispositive power, with 31,006,825 shares subject to shared voting power and 62,741,607 shares subject to shared dispositive power.

The filing explains that 27,972,813 of these shares are held through a French employee investment vehicle (FCPE) dedicated to Sanofi employees, where voting rights are exercised by the FCPE supervisory board rather than Amundi. Amundi certifies that the securities were acquired and are held in the ordinary course of business and not for the purpose of changing or influencing control of Sanofi.

Amundi and Amundi Asset Management filed an amended Schedule 13G reporting beneficial ownership of 62,741,607 Sanofi common shares and ADRs, representing 5.11% of the class. They report no sole voting or dispositive power, with 31,006,825 shares subject to shared voting power and 62,741,607 shares subject to shared dispositive power.

The filing explains that 27,972,813 of these shares are held through a French employee investment vehicle (FCPE) dedicated to Sanofi employees, where voting rights are exercised by the FCPE supervisory board rather than Amundi. Amundi certifies that the securities were acquired and are held in the ordinary course of business and not for the purpose of changing or influencing control of Sanofi.

Sanofi has filed its annual report on Form 20-F, outlining 2025 results and a wide range of risks that could affect future performance. The company prepares its consolidated accounts under IFRS and emphasizes that forward-looking statements are highly uncertain.

Sanofi spent €7,842 million on research and development in 2025, equal to 18.0% of net sales, while its key drug Dupixent generated net sales of €15,714 million, or 36.0% of total net sales. The United States represented 50.8% of net sales, underscoring exposure to US pricing and policy changes.

The report details major risks: product liability litigation, tightening global regulation, intellectual property challenges, cyber and data-privacy threats, complex manufacturing and supply chains, climate and geopolitical disruptions, and heavy dependence on a few blockbuster products. Sanofi highlights growing pressure from US and European pricing policies, including an MFN agreement with the US government and the Inflation Reduction Act, as significant long-term headwinds.

Sanofi has filed its annual report on Form 20-F, outlining 2025 results and a wide range of risks that could affect future performance. The company prepares its consolidated accounts under IFRS and emphasizes that forward-looking statements are highly uncertain.

Sanofi spent €7,842 million on research and development in 2025, equal to 18.0% of net sales, while its key drug Dupixent generated net sales of €15,714 million, or 36.0% of total net sales. The United States represented 50.8% of net sales, underscoring exposure to US pricing and policy changes.

The report details major risks: product liability litigation, tightening global regulation, intellectual property challenges, cyber and data-privacy threats, complex manufacturing and supply chains, climate and geopolitical disruptions, and heavy dependence on a few blockbuster products. Sanofi highlights growing pressure from US and European pricing policies, including an MFN agreement with the US government and the Inflation Reduction Act, as significant long-term headwinds.

Sanofi reported that its BTK inhibitor Wayrilz (rilzabrutinib) received FDA breakthrough therapy designation in the US and orphan drug designation in Japan for treating warm autoimmune hemolytic anemia (wAIHA), a rare autoimmune disease that destroys red blood cells and can cause serious complications.

Both designations are based on clinical data from the ongoing LUMINA 2 phase 2b study, with a new LUMINA 3 phase 3 trial comparing rilzabrutinib to placebo in wAIHA. Rilzabrutinib is already approved as Wayrilz for immune thrombocytopenia (ITP) in the US, EU, and UAE, and remains investigational for wAIHA and other rare immune-mediated diseases.

Sanofi reported that its BTK inhibitor Wayrilz (rilzabrutinib) received FDA breakthrough therapy designation in the US and orphan drug designation in Japan for treating warm autoimmune hemolytic anemia (wAIHA), a rare autoimmune disease that destroys red blood cells and can cause serious complications.

Both designations are based on clinical data from the ongoing LUMINA 2 phase 2b study, with a new LUMINA 3 phase 3 trial comparing rilzabrutinib to placebo in wAIHA. Rilzabrutinib is already approved as Wayrilz for immune thrombocytopenia (ITP) in the US, EU, and UAE, and remains investigational for wAIHA and other rare immune-mediated diseases.

Sanofi announced a major leadership transition, with its Board deciding not to renew Paul Hudson’s Director mandate, making February 17, 2026 his last day as Chief Executive Officer. The Board has appointed Belén Garijo as the new CEO, with her term starting after the Annual General Meeting on April 29, 2026, subject to shareholder approval of her appointment as a director and an amendment to the articles of association regarding the CEO age limit. During the transition, Olivier Charmeil, Executive Vice President, General Medicines, will serve as Interim CEO. Sanofi highlights Garijo’s global pharmaceutical leadership experience and states that her priorities will include strengthening productivity, governance, and the innovation capacity of Research & Development.

Sanofi announced a major leadership transition, with its Board deciding not to renew Paul Hudson’s Director mandate, making February 17, 2026 his last day as Chief Executive Officer. The Board has appointed Belén Garijo as the new CEO, with her term starting after the Annual General Meeting on April 29, 2026, subject to shareholder approval of her appointment as a director and an amendment to the articles of association regarding the CEO age limit. During the transition, Olivier Charmeil, Executive Vice President, General Medicines, will serve as Interim CEO. Sanofi highlights Garijo’s global pharmaceutical leadership experience and states that her priorities will include strengthening productivity, governance, and the innovation capacity of Research & Development.

Sanofi filed a Form 13F reporting its role as an institutional investment manager. The report lists 8 holdings with an aggregate market value of $310,414,825. The filing is signed by Alexandra Roger, Head of Legal Corporate & Finance, in Paris on 02-11-2026.

Sanofi filed a Form 13F reporting its role as an institutional investment manager. The report lists 8 holdings with an aggregate market value of $310,414,825. The filing is signed by Alexandra Roger, Head of Legal Corporate & Finance, in Paris on 02-11-2026.

Sanofi has completed its acquisition of Dynavax Technologies Corporation, adding the marketed adult hepatitis B vaccine HEPLISAV‑B and a shingles vaccine candidate (Z‑1018), along with additional vaccine pipeline projects. The transaction is intended to strengthen Sanofi’s position in adult immunization by combining Dynavax’s products with Sanofi’s global commercial and development capabilities.

The tender offer for all outstanding Dynavax common shares expired on February 9, 2026, and Sanofi accepted and will pay $15.50 per share in cash, without interest and subject to applicable taxes, for all validly tendered shares and, via a follow‑on merger, for all remaining shares. Dynavax has become an indirect, wholly owned Sanofi subsidiary, and its common stock will cease trading on the NASDAQ Global Select Market as of February 10, 2026.

Sanofi has completed its acquisition of Dynavax Technologies Corporation, adding the marketed adult hepatitis B vaccine HEPLISAV‑B and a shingles vaccine candidate (Z‑1018), along with additional vaccine pipeline projects. The transaction is intended to strengthen Sanofi’s position in adult immunization by combining Dynavax’s products with Sanofi’s global commercial and development capabilities.

The tender offer for all outstanding Dynavax common shares expired on February 9, 2026, and Sanofi accepted and will pay $15.50 per share in cash, without interest and subject to applicable taxes, for all validly tendered shares and, via a follow‑on merger, for all remaining shares. Dynavax has become an indirect, wholly owned Sanofi subsidiary, and its common stock will cease trading on the NASDAQ Global Select Market as of February 10, 2026.

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 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 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.