Financial Data and Key Metrics Changes - In Q4 2025, the company achieved net sales of EUR 11.3 billion, reflecting a growth of 13.3% year-over-year [6][12] - For the full year 2025, total sales reached EUR 43.6 billion, representing a 9.9% growth at constant exchange rates [14] - Business EPS growth was strong at 26.7%, indicating effective operational leverage [12] - Business gross margin expanded by 1.8 percentage points to 77.5%, driven by a favorable product mix and operational efficiencies [14] Business Line Data and Key Metrics Changes - Newly launched medicines and vaccines generated EUR 5.7 billion in sales, with a growth of 34% in 2025 [4][6] - Dupixent sales reached EUR 4.2 billion in Q4 and EUR 15.7 billion for the full year, with over 30% increase in patient numbers [7][8] - Beyfortus sales grew by 9.5% to EUR 1.8 billion, driven by geographic expansion [8][9] Market Data and Key Metrics Changes - The company maintained leadership in influenza and RSV vaccines, with full year sales of EUR 7.9 billion [8] - The U.S. market share for influenza vaccines increased, particularly with Fluzone High-Dose and Flublok [8] - Beyfortus has protected over 11 million babies in more than 45 countries, preventing an estimated 200,000 hospitalizations [9] Company Strategy and Development Direction - The company is transitioning into an R&D-driven, AI-powered biopharma entity, focusing on business development and M&A opportunities [4] - Strategic acquisitions, including Vicebio and Dynavax Technologies, are aimed at enhancing the vaccine portfolio and expanding into older adult demographics [9][10] - The company plans to continue investing in manufacturing capacity to meet growing patient demand [14] Management's Comments on Operating Environment and Future Outlook - Management expects 2026 to deliver profitable growth close to 2025 levels, with high single-digit sales growth anticipated [17][18] - The company is preparing for potential challenges in vaccine sales and is focused on maintaining a stable G&A expense structure [18] - Management highlighted the importance of innovation and collaboration in achieving sustainable healthcare goals [10] Other Important Information - The company completed a EUR 5 billion share buyback program and proposed a 5% increase in dividends for the 31st consecutive year [17] - Free cash flow returned to strong levels at EUR 8.1 billion, representing 18.5% of sales, with a target of reaching at least 20% in the medium term [15] Q&A Session Summary Question: Can you elaborate on the Dupixent rollout and its competition? - Management reported strong performance with 25% year-over-year growth for Dupixent, driven by new indications like CSU and COPD [30][31] Question: What is the growth outlook for Beyfortus in 2026? - Management expressed optimism about Beyfortus performance, noting its availability in over 45 countries and a positive real-world evidence publication [34][36] Question: What are the prospects for Amlitelimab and its market penetration? - Management remains confident in Amlitelimab's potential, emphasizing its novel mechanism and the importance of ongoing data collection [39][41] Question: How is the company addressing the recent changes in the U.S. pediatric vaccination schedule? - Management acknowledged potential confusion but emphasized proactive engagement with healthcare providers to maintain vaccination rates [77][78] Question: What is the strategy for capital allocation moving forward? - Management indicated a dynamic allocation strategy guided by AI, focusing on maximizing value from investments [60]

Core Insights - The company reported a Q4 sales growth of 13.3% at constant exchange rates (CER) and a business earnings per share (EPS) of €1.53, reflecting strong performance driven by new medicines and Dupixent [1][2]. Sales Performance - In Q4 2025, net sales reached €11.3 billion, marking a 7.0% increase year-over-year at actual exchange rates and a 13.3% increase at CER [5]. - For the full year 2025, net sales totaled €43.6 billion, with a 6.2% increase at actual exchange rates and a 9.9% increase at CER [5]. Earnings Performance - Business EPS for Q4 2025 was €1.53, up by 16.8% at actual exchange rates and 26.7% at CER [5]. - The full year 2025 business EPS improved to €7.83, reflecting a 10.0% increase at actual exchange rates and a 15.0% increase at CER [5]. Product Developments - The company launched three new medicines and vaccines in 2025, contributing to sales growth [3]. - Dupixent sales increased by 32.2% to €4.2 billion, while pharmaceutical launches increased sales by 49.4%, reaching €1.1 billion [4]. Regulatory Approvals and R&D - The company obtained ten regulatory approvals across various therapeutic areas, including immunology and rare diseases [4]. - Research and Development expenses reached €2.3 billion, up by 6.6%, indicating continued investment in innovation [4]. Future Guidance - For 2026, the company expects sales to grow by a high single-digit percentage at CER, with business EPS anticipated to grow slightly faster than sales [2][4]. - A share buyback program of €1 billion is planned for 2026 [2]. Financial Management - The company completed a €5 billion share buyback program and proposed a dividend of €4.12, up by 5.1% [4]. - Free cash flow for Q4 2025 was €2.6 billion, reflecting a 12.7% increase [5].

R&D Leadership and Organization - Sanofi is building a skilled and thoughtful R&D leadership team and organization[5, 6, 7, 106] - The company is strengthening capabilities across research, translational medicines, development, medical, regulatory affairs, and digital[106] Pipeline Highlights and Approvals - Sanofi achieved three new medicine and vaccine approvals in 2025: Qfitlia, Wayrilz, and Nuvaxovid[12, 13, 106] - Dupixent showed benefit across relevant endpoints in Bullous pemphigoid, with 12.2% difference in patients achieving sustained remission compared to placebo + OCS and 27.8% difference in patients with ≥4-point improvement in PP-NRS[20, 21] - Dupixent clinically meaningfully improved radiographic, endoscopic, and symptoms of Allergic fungal rhinosinusitis, with lower proportion of patients receiving SCS treatment and/or surgery[24] - Amlitelimab (OX40L mAb) in AD: first phase 3 study met primary and key secondary endpoints, showing clinically meaningful improvement in skin clearance and disease severity[26] - Brivekimig (TNFaxOX40L Nanobody®) in HS: phase 2a study achieved primary objective, with 54% of participants achieving HiSCR75[28, 29] - Itepekimab (IL33 mAb) in COPD: AERIFY-1 study showed a significant reduction in moderate or severe exacerbations of 27.1% at Week 52 with Q2W dosing across EOS level[38] - Duvakitug (TL1A mAb) in CD/UC: positive and encouraging phase 2b data presented at ECCO 2025, with 48% clinical remission in Crohn's disease high dose group[46, 47] - Fluzone HD demonstrated superior protection vs standard-dose influenza vaccines against hospitalization in older adults, including a -31.9% reduction in laboratory confirmed influenza hospitalization[75] - Monovalent RSV (mRNA) vaccine showed 74.9% efficacy against RSV LRTD in a phase 2 study[80] Pipeline Replenishment and Digital Transformation - Sanofi is progressing on pipeline entries augmented by strategic business development[107] - The R&D digital plan aims at reducing cycle times across the R&D value chain by more than 40%[94, 95, 107] Upcoming News Flow - Sanofi anticipates >15 regulatory decisions, >30 regulatory submissions, and >15 phase 3 data readouts in 2026 and 2027[108]

Two bleeding disorder treatments for both chronic and acute conditions, Qfitlia and Cablivi, have been approved in China. https://t.co/jYTwWsGrU4 ...

Core Insights - Two treatments for bleeding disorders, Qfitlia and Cablivi, have received approval in China [1] Group 1 - Qfitlia is indicated for chronic bleeding disorders [1] - Cablivi is indicated for acute bleeding disorders [1]

Core Insights - The National Medical Products Administration (NMPA) in China has approved two innovative Sanofi medicines for rare hematologic diseases: Qfitlia for hemophilia and Cablivi for acquired thrombotic thrombocytopenic purpura (aTTP) [1] - These approvals represent Sanofi's fourth and fifth approvals in China for the year, following Tzield and Sarclisa [1] Qfitlia Overview - Qfitlia is the first antithrombin-lowering therapy for routine prophylaxis in hemophilia patients aged 12 and older, including those with severe hemophilia A or B [2] - The approval is based on ATLAS phase 3 studies showing significant reductions in annualized bleeding rates (ABR) for patients treated with Qfitlia [3] - Qfitlia utilizes small-interfering RNA technology, allowing for low treatment frequency and subcutaneous administration [3][15] - Hemophilia affects over 40,000 individuals in China, highlighting the need for effective treatment options [3] Cablivi Overview - Cablivi is the first targeted therapy for treating aTTP in adults and adolescents aged 12 or older [4] - Approximately 2,700 patients are diagnosed with aTTP annually in China, with a mortality rate of up to 20% despite standard treatments [5] - Cablivi works by inhibiting the interaction between von Willebrand factor and platelets, thus preventing microthrombi formation [5][18] Market Impact - The approvals of Qfitlia and Cablivi expand Sanofi's rare hematology portfolio in China, addressing critical unmet needs in chronic bleeding disorders and acute clotting emergencies [6] - Sanofi's commitment to innovation is emphasized by these approvals, aiming to improve outcomes for patients with rare diseases [7] Clinical Results - Qfitlia demonstrated a 71% reduction in ABR for patients without inhibitors and a 73% reduction for patients with inhibitors compared to traditional treatments [9] - In the open-label extension study, nearly 80% of participants were on a regimen of six injections per year, with 94% achieving target AT levels [17]

Core Insights - Sanofi's Specialty Care division is positioned for significant growth, focusing on immunology, oncology, neurology, and rare diseases [3][4] - The company anticipates dupilumab to achieve a compound annual growth rate (CAGR) in the double digits from 2023 to 2030, potentially generating around EUR 22 billion by 2030 [4] Company Overview - Sanofi has streamlined its business units from four to three following the sale of its Consumer Health Opella, now comprising General Medicines, Vaccines, and Specialty Care [3] - The Specialty Care business unit is expected to drive growth through recently launched products such as ALTUVIIIO and Qfitlia, alongside the expanding indications for SARCLISA in oncology and multiple myeloma [4]