CEO Paul Hudson: Confidence in Full-Year Outlook

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.”

Sanofi has kicked off 2025 with resounding momentum, posting 9.7% sales growth at constant exchange rates (CER)and demonstrating strong operational resilience amid global headwinds. With net sales soaring to €9.9 billion and business EPS climbing 15.7% at CER to €1.79, Sanofi reaffirmed its full-year guidance, underlining confidence in its innovation-led growth strategy.

Key Drivers Behind the Numbers:

• Innovation Pays Off: Sales from new product launches skyrocketed 43.8% to €847 million, driven by ALTUVIIIO’s explosive debut in hemophilia A treatment. The therapy’s 100% sales growth cements its trajectory toward blockbuster status.

• Immunology Powerhouse: Dupixent remains a cornerstone of Sanofi’s portfolio, delivering €3.5 billion in Q1 sales, up 20.3%, as its reach expands across multiple indications, including asthma, COPD, and atopic dermatitis. The recent COPD launch in Japan and over 45 global markets strengthens its leadership in immunology.

• Geographic Growth Engine: The U.S. market surged 15.4%, powered by Dupixent, ALTUVIIIO, and vaccines, while Europe held steady and Rest of World regions grew 8.4%, demonstrating balanced global performance. China faced a slight dip (-1.7%), impacted by national drug pricing policies.

Pipeline on Fire: Six Approvals, New Therapies Set to Redefine Standards

Sanofi’s pipeline continues to outperform, with six regulatory approvals spanning immunology, oncology, and rare diseases. Highlights include:

• Qfitlia, a game-changer for hemophilia A and B, secured U.S. approval, with first sales expected in Q2.

• Dupixent extended its COPD reach in Japan and awaits a U.S. decision for bullous pemphigoid, a debilitating skin disease.

• Sarclisa, Sanofi’s multiple myeloma therapy, achieved expanded approvals across Japan, EU, and China, enhancing its global footprint.

Strategic Moves: Fueling Future Growth

Sanofi’s growth is not just organic—it’s strategic. The company:

• Struck a deal to acquire DR-0201, a bispecific myeloid cell engager, enhancing its immunology pipeline with a potential breakthrough in lupus treatment.

• Progressed on the €5 billion share buyback program, with 72% completed, underscoring Sanofi’s commitment to shareholder returns.

• Advanced the sale of a controlling stake in Opella to CD&R, streamlining operations and unlocking capital for innovation.

Sustainability with Substance: AIR Strategy Takes Flight

Sanofi unveiled its updated AIR (Access, Impact, Resilience) sustainability strategy, designed to:

• Expand access to care for diseases impacted by environmental changes.

• Achieve Net Zero greenhouse gas emissions by 2045.

• Enhance healthcare system resilience against environmental pressures.

Notably, 70% of Sanofi’s portfolio and 75% of its pipeline target diseases worsened by climate change, demonstrating an integrated approach to health and environment.

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