Fitusiran

Sanofi posted a strong set of first-quarter results Thursday morning, with its recombinant factor drug Altuviiio on track to become a blockbuster drug and its crown jewel Dupixent continuing to draw sales. Sales of the French drugmaker’s hemophilia A treatment Altuviiio doubled in the first quarter to €251 million ($286 million), according to a company earnings report . Almost 90% of that number was driven by the US, where patients continued to switch over from older plasma-derived and recombinant factor medicines. The remaining €33 million came from other markets, boosted by a recent launch in Japan. Altuviiio has been steadily gaining market share since it secured FDA approval in 2023, according to Sanofi. If it can replicate its Q1 sales for the rest of the year, the product should reach blockbuster status in 2025, a company spokesperson told Endpoints News in an email. Altuviiio is administered weekly, giving it a significant convenience edge over older recombinant factor drugs, which can require up to thrice weekly dosing. Sanofi’s older recombinant factor medicine, Eloctate, saw sales drop around 21% to €70 million as patients switched to Altuviiio. But its broader hemophilia A franchise fared positively, with sales rising by 50% to €321 million. That number formed part of Sanofi’s total first-quarter sales of €9.9 billion, which were up almost 10% from the same time last year. The figure came in 3% ahead of Wall Street consensus forecasts and was driven by continued growth of the company’s blockbuster inflammatory disease drug Dupixent, Jefferies analysts said in a Thursday note. Dupixent sales were up around 20% in the quarter to €3.5 billion. The growth was driven by rising use in all established indications, as well as “emerging use” in its latest approval for chronic obstructive pulmonary disorder, Sanofi said. Dupixent is expected to reach peak sales of $3.3 billion in COPD alone, according to Wall Street consensus estimates. Sanofi’s hemophilia offering was further bolstered by an FDA approval for siRNA medicine Qfitlia in hemophilia A and B last month. Qfitlia will be sold in the US at an average cost of $642,000 per year, but comes with a boxed warning for thrombotic events and gallbladder disease. Sanofi also reported a Phase 2 disappointment for its oral TNF inhibitor, balinatunfib, in psoriasis. The drug did not hit statistical significance in the primary endpoint of PASI-75, which measures the proportion of patients with a minimum 75% improvement in their psoriasis area and severity index score. Sanofi said the failure was driven by “the limited nature” of the trial, adding it would share full data at a future medical meeting. For now, the company is considering potential combination approaches for balinatunfib. Elsewhere, Sanofi made several cuts to its cancer pipeline. The drugmaker terminated a Phase 2 trial for NK cell engager SAR443579 in acute myeloid leukemia and a Phase 1 study of monoclonal antibody SAR444881 in solid tumors. The cuts are part of a broader pipeline prioritization that should help the company focus on its goal of becoming a world leader in immunology, the spokesperson said. On a call with the media on Thursday, CFO François Roger said the company is continuing to assess how the looming pharma tariffs would impact its business. Editor’s Note: This article was updated to add information about the balinatunfib trial failure and the company’s comments on potential pharma tariffs.

Sanofi: strong Q1 performance and 2025 guidance confirmed Paris, April 24, 2025 Q1 sales growth of 9.7% at CER1 and business EPS2 of €1.79 Pharma launches reached sales of €0.8 billion, up 43.8%, driven by ALTUVIIIODupixent sales were €3.5 billion, up 20.3%Vaccines sales were €1.3 billion, up 11.4%, driven by favorable Beyfortus phasingResearch and Development expenses reached €1.8 billion, up 6.9%Selling, general and administrative expenses were €2.2 billion, up 3.8%Business EPS was €1.79, up 15.7% at CER and up 17.0% reported; IFRS EPS was €1.52 Pipeline continued to deliver Six regulatory approvals across medicines in immunology, rare diseases, and oncologyRecent new data from the mid-stage pipeline unlocks late-stage studies in asthma and skin diseases, broadening and deepening the scope in immunology Sustainability strategy Updated sustainability strategy focuses on access to healthcare, environmental impact, and resilience of healthcare systems. 70% of the portfolio and >75% of the pipeline target diseases that are impacted by climate and environmental challenges Capital allocation The closing of the sale of a controlling stake in Opella to CD&R is anticipated in Q23Sanofi has agreed to acquire DR-0201, a targeted bispecific myeloid cell engager4 Guidance confirmed In 2025, sales are anticipated to grow by a mid-to-high single-digit percentage at CER5. Sanofi confirms the expectation of a strong rebound in business EPS with growth at a low double-digit percentage at CER (before share buyback)6Sanofi intends to complete a share buyback program in 2025 of €5 billion of which 72% was already repurchased Paul Hudson, Chief Executive Officer: “We had a strong start in 2025 with sales growth of 9.7%, benefiting from investments in innovation and a favorable base of comparison. Our focus on pipeline value delivered further growth for Sanofi with sales from launches of new medicines and vaccines growing by 46.5%. We obtained approval for Qfitlia (fitusiran), a new treatment for patients with hemophilia, one of three potential launches this year. ALTUVIIIO is continuing to gain market share and is on track to become our next blockbuster in the full year. Business EPS was €1.79, confirming the expected strong rebound in 2025. Our redeployment of capital continued with significant progress on our share buyback program, the upcoming closing of the sale of a majority stake in Opella and the recent acquisition of a bispecific myeloid cell engager for deep B-cell depletion in immunology, strengthening our early pipeline and providing a potential treatment option in difficult-to-treat diseases like lupus. We achieved significant advances in the pipeline with six approvals. We also delivered steady progress across many new medicines in respiratory diseases and dermatology, including clinically meaningful efficacy for amlitelimab in asthma, allowing us to enter phase 3 development to create future value for patients, society, and our company. Underpinned by the growth in sales and business EPS, we confirm our 2025 guidance with the knowledge of the external environment we have today.” Q1 2025 Change Change at CER IFRS net sales reported €9,895m +10.8% +9.7% IFRS net income reported €1,872m +65.2% — IFRS EPS reported €1.52 +67.0% — Free cash flow7 €1,029m — — Business operating income €2,902m +20.1% +18.7 % Business net income €2,212m +15.9% +14.5 % Business EPS €1.79 +17.0% +15.7% Attachment Press_Release