Introduction Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. In the remainder of this section, medicines and vaccines are referred to either by their international non-proprietary name (INN) or their brand name, which is generally exclusive to the company that markets it. In most cases, the brand names of our medicines and vaccines, which may vary from country to country, are protected by specific registrations. In this document, medicines and vaccines are identified by their brand names used in France and/or in the US. The segment information presented by Sanofi consists of a single operating segment: Biopharma. The Biopharma operating segment comprises commercial operations and research, development and production activities relating to the Specialty Care, General Medicines, and Vaccines franchises plus support and corporate functions, for all geographical territories. It also includes revenues generated from the manufacture of Consumer Healthcare products invoiced to Opella Healthcare SAS (Opella), which constitutes a related party with effect from April 30, 2025, the deconsolidation date, corresponding to the closing of Sanofi's sale of a controlling stake of approximately 50% in Opella to Clayton, Dubilier & Rice (CD&R) (for more information, see “Item 4. Information on the Company — B. Business overview — B.3 Opella”). Those revenues, which before the deconsolidation date represented intragroup transactions classified within continuing operations, are presented within Other revenues in the income statement. The Biopharma operating segment also includes the purchase price of Biopharma products manufactured by Opella. The “Other” category comprises primarily, but not exclusively, Consumer Healthcare activities not transferred on the effective date of loss of control of Opella. These are primarily (i) hospital sales of Opella products in China, the transfer of which will be finalized no earlier than 2028; (ii) sales made by the dedicated entity Opella Russie, of which Sanofi continues to hold the capital (Sanofi is continuing to distribute Opella products in Russian territory under a distribution agreement signed in connection with the separation, the parties reserving the right to discuss the transfer of that entity during the term of the distribution agreement); and (iii) sales of the Gold Bond product range, which are continuing in the US through the retained subsidiary Gold Bond LLC (holder of the associated worldwide property rights). A. History and development of the Company The current Sanofi company was incorporated under the laws of France in 1994 as a société anonyme, a form of limited liability company, for a term of 99 years. Since May 2011, we have operated under the commercial name “Sanofi” (formerly known as Sanofi-Aventis). Our registered office is located at 46, avenue de la Grande Armée – 75017 Paris – France, our main telephone number is +33 1 53 77 40 00, and our website (which contains information about the company and information filed with and provided to the SEC) is www.sanofi.com. Our principal US subsidiary’s office is located at 100 Morris Street, Morristown, New Jersey 07960 telephone: +1 (908) 981 5000. The SEC maintains a website at http://www.sec.gov that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC. Main events over the last three years On March 13, 2023, Sanofi and Provention Bio, Inc. (Provention), a US-based publicly-traded biopharmaceutical company developing therapies to prevent and intercept immune-mediated diseases including type 1 diabetes, entered into an agreement under which Sanofi acquired the outstanding shares of Provention common stock for $25.00 per share in an all-cash transaction valued at approximately $2.8 billion. On April 27, 2023, Sanofi announced the completion of its acquisition of Provention. The acquisition added Tzield/Teizeild (teplizumab), a therapy for type 1 diabetes, to our portfolio. On May 30, 2024, Sanofi announced that it had completed the acquisition of Inhibrx, Inc. (Inhibrx), a publicly-traded, clinical-stage biopharmaceutical company focused on developing a pipeline of novel biologic therapeutic candidates in oncology and orphan diseases. The acquisition added efdoralprin (formerly INBRX-101) to Sanofi’s rare disease development portfolio. Under the terms of the merger agreement, Sanofi agreed to (i) pay Inhibrx stockholders $30 per share of Inhibrx common stock on closing of the merger (approximately $1.7 billion) and issue one non-transferable contingent value right (CVR) per share of Inhibrx common stock, entitling its holder to receive a deferred cash payment of $5, contingent upon the achievement of certain regulatory milestones (approximately $0.3 billion, if those milestones are achieved); (ii) pay off Inhibrx’s outstanding third-party debt (approximately $0.2 billion); and (iii) contribute capital to a new publicly traded company (New Inhibrx) (at least $0.2 billion). Since the closing of the merger, Inhibrx has become a wholly owned subsidiary of Sanofi. Additionally, Sanofi retains a minority stake (approximately 8%) in New Inhibrx. On October 21, 2024, Sanofi and CD&R entered into exclusive negotiations for the Opella Transaction, as defined under "— B.3. Opella," which led to the loss of control previously exercised by Sanofi over Opella and triggered Opella's reclassification as a discontinued operation under IFRS 5 for the 2024 financial year. As a result, Opella’s post-tax profit or loss was presented 18 SANOFI FORM 20-F 2025 PART I ITEM 4. Information on the Company separately within the line item Net income/(loss) from discontinued operations in Sanofi’s consolidated income statement for 2024 and comparative periods. Following these negotiations, Sanofi sold a 50% controlling stake in Opella to CD&R pursuant to a share purchase agreement and a separation agreement, and on April 30, 2025, the parties closed the Opella Transaction (for more information on these agreements and the Opella Transaction, see "— B.3. Opella"). As a result of the transaction, Sanofi recognized a net gain of €2.6 billion, reported within the line item Net income from discontinued operations in the consolidated income statement. Sanofi received total net cash proceeds of €10.4 billion, presented within the line item Net cash inflow from the Opella transaction in the statement of cash flows. On November 29, 2024, Sanofi entered into a definitive agreement with Recordati S.p.A (Recordati) for the sale of Sanofi's global rights to Enjaymo; for more information, see “Item 5. — A.1.9. Divestments.” On May 27, 2025, Sanofi announced the completion of its acquisition of DR-0201, a targeted bispecific antibody developed by Dren Bio, Inc., a privately held clinical-stage biopharmaceutical company; for more information, see “Item 5. — A.1.1. 2025 Overview.” On July 18, 2025, Sanofi announced the completion of its acquisition of Blueprint Medicines Corporation (Blueprint); for more information, see “Item 5. — A.1.1. 2025 Overview.” On August 5, 2025, Sanofi announced the completion of its acquisition of Vigil Neuroscience, Inc. (Vigil); for more information, see “Item 5. — A.1.1. 2025 Overview.” On September 24, 2025, Sanofi Ventures announced an additional $625 million multi-year capital commitment from Sanofi; for more information, see “Item 5. — A.1.1. 2025 Overview.” On December 4, 2025, Sanofi announced the completion of its acquisition of Vicebio Ltd (Vicebio); for more information, see “Item 5. — A.1.1. 2025 Overview.” On December 19, 2025, Sanofi entered into a major strategic agreement with the US government; for more information, see “Item 5. — A.1.1. 2025 Overview.” On December 24, 2025, Sanofi announced that it had entered into an agreement to acquire Dynavax Technologies Corporation (Dynavax); for more information, see “Item 5. — A.1.1. 2025 Overview.” More detailed information about these changes is provided in Note D.1. to our consolidated financial statements, included at Item 18. of this annual report. B. Business overview Sanofi’s activities are organized around the following categories within the Biopharma operating segment : Immunology, Rare Diseases, Neurology, Oncology, Other Medicines and Vaccines. B.1. Strategy The market context for Sanofi Several fundamental trends continue to point to a positive outlook for the pharmaceutical industry. The global population is growing and ageing, and unmet medical needs remain high. Health needs have further increased, strengthening the key roles of innovation in R&D activities and cutting-edge manufacturing. The industry has taken steps to increase R&D productivity, with the objective of launching a higher number of innovative medicines and vaccines. Patients around the world – including a rising middle class in emerging markets – are demanding better healthcare, empowered by access to more and more information. It is a challenging time scientifically and technologically: the promise of artificial intelligence (AI) is generating new insights into how to diagnose and treat diseases, and Immunology remains a key therapeutic area with high unmet needs. Digital technologies and advanced data analytics are having a transformative effect across sales and marketing activities, R&D and manufacturing, and are acting as enablers for new businesses. At the same time, increased geopolitical uncertainties, inflation, supply shortages, and issues around government budget tightening are expected to continue to put pressure on healthcare costs, and on the entire healthcare value chain. Although we believe that pharmaceuticals and vaccines will remain a fundamentally attractive business within that value chain, the bar for innovation will most likely continue to rise. Payers will continue to put scrutiny on prices and reimbursement criteria, and demand demonstration of real-life outcomes to confirm the efficacy of medicines and vaccines. This will be coupled with more innovative pricing and contracting practices, and more transparent pricing policies. In view of growing concerns over increasing healthcare costs across global markets, the pharmaceutical industry will be increasingly judged by its contribution to improved access for patients and to the development of innovative, highly cost-effective medicines. Strategic framework Further, faster for patients We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that positively impact millions of (1)In partnership with Regeneron. SANOFI FORM 20-F 2025 19 PART I ITEM 4. Information on the Company patients suffering from dermatological, respiratory, gastroenterological, and other immune-mediated diseases. And we are pioneering an innovative pipeline that could benefit millions more. We are on a mission to go further, faster for patients. We seek to take the lead through breakthrough science and by leveraging our broad set of technology and manufacturing platforms, including mRNA. Advancing Breakthrough Science We are working to strengthen our pipeline with a steady stream of potentially transformative therapies that could shift paradigms in treatment and prevention for people across the world. We have a powerful toolbox of drug discovery platforms that allow us to break scientific ground in five therapeutic areas: Immunology and Inflammation, Oncology, Rare diseases, Neurology and Vaccines. Advancing Sustainability Our ambition is to tackle the impact of environmental challenges on health and healthcare. We do this by focusing on three dimensions: improving equitable and sustainable access to healthcare, reducing the environmental impact of our activities, and helping transform the delivery of care to minimize the environmental footprint of healthcare systems. Further, we work actively to embed sustainability in everything we do across the business. This builds on our “Play to Win” strategy, organized around four key priorities: 1) focus on growth; 2) lead with innovation; 3) accelerate efficiency; and 4) reinvent how we work to drive innovation and growth. 1) Focus on growth •Dupixent (dupilumab)(1) – By leveraging the product’s unique mechanism of action targeting the type 2 inflammation pathway and its favorable safety profile, we have raised our ambition for peak sales of Dupixent. In 2025, Dupixent received approval in the US in bullous pemphigoid (BP), as well as US and EU approval in chronic spontaneous urticaria (CSU). •Launches – in 2025 Sanofi successfully launched Wayrilz in immune thrombocytopenia, Qfitalia in hemophilia A or B with or without inhibitors, and Nuvaxovid for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). •Vaccines – Sanofi has been focusing on four core franchises: Influenza and COVID-19; Meningitis, Travel and Endemics; Polio, Pertussis and Hib (PPH) & Boosters; and RSV. •Pipeline – We are focusing our investments on projects in immunology and Inflammation, Oncology, Rare diseases, Neurology and Vaccines. 2) Lead with innovation We have been able to shift from a priority medicine list to a steady flow of medicines in a refocused, consistent pipeline. Our pipeline is showing potential opportunities for market-leading products. To continue fueling our promising pipeline and to enhance our position in our core therapeutic areas, we have: i.entered into a license agreement with ADEL, Inc. for development and commercialization rights for ADEL-Y01, which has first-in-class potential for Alzheimer's; ii.acquired Vicebio, adding an early-stage combination vaccine candidate for RSV and HMPV; iii.entered into a research collaboration agreement with InduPro, Inc. (InduPro or InduProTherapeutics) to collaborate on preclinical and IND-enabling research activities, as well as the right of first negotiation for InduPro’s bispecific PD-1 agonist program, currently in preclinical development for the treatment of autoimmune and inflammatory disorders; iv.entered into a collaboration agreement with EVOQ Therapeutics, Inc. (EVOQ) establishing a partnership that enhances our immunology portfolio by integrating EVOQ’s cutting-edge Antigen Specific Immunotherapy (ASI) technology, designed to restore immune tolerance to self-antigens by selectively re-educating the immune system; v.acquired Vigil to strengthen our early-stage pipeline in neurology with VG-3927, a novel, oral, small-molecule TREM2 agonist which will be evaluated in a Phase 2 clinical study in patients with Alzheimer’s disease; vi.entered into a licensing agreement with VisiRNA Therapeutics, Inc. for the exclusive development and commercialization rights of plozasiran in the territory of Greater China; vii.acquired Blueprint, adding a rare immunology disease medicine, Ayvakit/Ayvakyt (avapritinib), approved in the US and EU and the only approved medicine for advanced and indolent systemic mastocytosis (ASM & ISM); viii.entered into a licensing agreement with Libertas Bio, Inc. (a subsidiary of Formation Bio) providing access to Gusacitinib, a dual JAK/SYK inhibitor, with the intention of exploring its potential as a second line treatment in chronic graft-versus-host disease (cGVHD) and potentially later in newly diagnosed cGvHD as a steroid free option; ix.acquired DR-0201, a targeted bispecific myeloid cell engager, from Dren Bio, Inc., to broaden our immunology pipeline and; x.entered into an agreement to acquire Dynavax Technologies Corporation (Dynavax), a publicly traded vaccines company with a marketed adult hepatitis B vaccine (HEPLISAV-B) and a differentiated shingles vaccine candidate. 20 SANOFI FORM 20-F 2025 PART I ITEM 4. Information on the Company 3) Accelerate efficiency We continue to improve our cost structure, launching efficiency initiatives across our Biopharma business to free operational resources to support R&D investment and unlock value-creation opportunities. This includes prioritizing our investments in R&D and modernizing our approach to commercial delivery. To transform the practice of medicine, we are developing and deploying AI-powered solutions across all business units at all levels of Sanofi, not only to increase automation and efficiency, but also to fundamentally change the way we work and think. We are investing in computational tools and AI to develop a comprehensive digital healthcare platform for employees, patients and providers. AI and data science are already supporting our teams in areas such as accelerating drug discovery, improving clinical trial design, and streamlining the manufacture and supply of drugs and vaccines. We are driving a company-wide culture shift that embeds digital DNA into the fabric of our organization. Our R&D teams are already accelerating their work: our Target Discovery engines have delivered seven novel drug targets in just one year. Our Manufacturing & Supply (M&S) teams use our AI-powered yield analytics platform, which assesses data trends from past batches, recommends production parameter adjustments and optimizes raw material use to deliver consistently higher yields. Across the value chain — from demand planning to quality assurance (QA) — AI-driven automation is being deployed to boost productivity and agility. AI tools like the Inventory Optimizer, Launch Agent, and Quality Agent are being used to enable faster, smarter decisions, from allocating production batches, to de-bottlenecking QA workflows, to optimizing launch plans for success. Our Portfolio Strategy teams are using our enterprise AI layer, Plai, for predictions and strategic recommendations to make the right decisions about our treatments to maximize patient impact. In recent years, we have achieved key AI milestones across the business: •in partnership with Aily Labs GmbH, we deployed the internal application Plai. Plai aggregates internal data across all functions and harnesses the power of AI to provide timely insights and personalized “what if” development scenarios to support informed decision-making. Today, over 22,000 of our employees use Plai for day-to-day decision making; •the expansion of our accelerators continued with the official announcement of our Digital Manufacturing & Supply (M&S) Accelerator, and talent growth in both our R&D and M&S accelerators; •in research, we have built multiple AI programs seeking to reduce research lead-times through improved predictive modelling and automated time-sink activities, enabling our R&D teams to scale and accelerate research processes. Initial results suggest potential improvements in target identification efficiency in therapeutic areas like immunology, oncology and neurology, though actual results may vary and are subject to ongoing validation; •in Manufacturing & Supply, we have developed an in-house AI-enabled yield optimization solution called SimpLY, which learns from past and current batch performance in an effort to enable consistently higher yield levels. This optimizes usage of raw materials, supports our environmental efforts, and enhances our cost efficiency. At our sites in France and Singapore, SimpLY analyzed over 13,000 batch runs of our anticoagulant (Lovenox/Clexane), enabling process optimizations that we estimate to have generated approximately €10 million in annual cost savings based on our internal analysis of batch performance improvements at these sites. Actual savings may vary and are subject to ongoing operational factors; •we have partnered with FormationBio and OpenAI to develop AI-powered software to accelerate drug development, create custom drug development lifecycle solutions and bring new medicines to patients more efficiently: these AI-powered digital products rely on advanced AI models to create rich, multidimensional patient profiles, pinpoint outreach channels, and generate IRB-ready, personalized content – nearly instantly and at scale; •in 2025, we held a Digital Month that engaged over 20,000 of our employees worldwide, with the aim of continuing to empower and inform people across our organization and drive adoption of our Digital and AI tools; •Sanofi's internal GenAI tools are maturing rapidly: Concierge (launched in October 2024) provides access to over 20,000 data points, supports over 30,000 users and has enabled two hours weekly saved on average per user; and • approximately 7,000 of Sanofi employees received training via GenAI courses on SanofiU, our in-house learning platform. 4) Reinvent how we work Transformation and simplification have started, with the aim of increasing empowerment and accountability. To drive implementation of our culture built on stronger focus, inclusivity and teamwork, we have streamlined our executive leadership team around 13 members. The complete Sanofi Executive Committee now includes the three managers who head up our Global Business Units (Specialty Care, General Medicines, and Vaccines) as well as the heads of each of the following support functions: Research and Development; Manufacturing & Supply; Finance; People & Culture; Digital; Legal, Business Integrity & Global Security; Corporate Affairs; and Business Operations. In 2025, as part of the streamlining of our focus, we announced the closing of the sale to CD&R of a 50.0% controlling stake of our consumer healthcare business, Opella. We retain a significant shareholding in Opella with a 48.2% stake. Sanofi received total net cash proceeds of around €10 billion. For more information on the transaction, see "— B.3 Opella." We introduced an updated sustainability strategy in 2025, focused on the critical nexus between health and the environment. Our strategic focus recognizes that 70% of our medicine and vaccine portfolio and more than 75% of our pipeline target diseases are impacted by climate and environmental challenges. The AIR strategy is threefold: Access to healthcare; Impact on the environment; and Resilient healthcare systems. It aims to: i.expand access to care for conditions affected by environmental challenges; SANOFI FORM 20-F 2025 21 PART I ITEM 4. Information on the Company ii.reduce the environmental impact of our products and activities, while adapting to environmental changes; and iii.change the delivery of care through treatments and efforts that reduce the environmental footprint of healthcare systems. Capital allocation policy We will continue to pursue our focused and disciplined capital allocation policy. Our priorities in deploying the cash generated from our operations are, in the following order: (i) investment in organic growth; (ii) business development and merger & acquisition activities, focusing on bolt-on, value-enhancing opportunities to drive scientific and commercial leadership in core therapeutic areas; (iii) growing the annual dividend; and (iv) anti-dilutive share buybacks. We also have the potential to raise capital through asset disposals, including streamlining “tail” brands in our established products business. B.2. Biopharma segment The sections below provide additional information on our main medicines. Our intellectual property rights over our biopharma medicines are material to our operations and are described at “B.6. Patents, Intellectual Property and Other Rights” below. As indicated in note D.22. to the consolidated financial statements, included at Item 18. of this annual report, we are involved in significant litigation concerning the patent protection of a number of these medicines. For more information on sales performance in 2025, see “Item 5. Operating and Financial Review and Prospects — A. Operating Results.” Immunology Dupixent Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. Dupilumab is jointly developed by Sanofi and Regeneron Pharmaceuticals, Inc. (Regeneron) under a global collaboration agreement. To date, dupilumab has been studied across more than 59 completed studies and 23 ongoing studies, involving more than 12,000 patients with various chronic diseases driven in part by type 2 inflammation. The dupilumab development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 studies, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple inflammatory diseases such as atopic dermatitis (AD), asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis and prurigo nodularis. Dupixent comes in either a pre-filled syringe for use in a clinic or at home by self-administration as a subcutaneous injection or in a pre-filled pen for at-home administration, providing patients with a more convenient option. Dupixent is available in all major markets including the US (since April 2017), most European Union countries (the first launch was in Germany in December 2017), Japan (since April 2018), and China (since June 2020). Atopic dermatitis (AD) Moderate-to-severe AD, a form of eczema and a chronic inflammatory disease, is characterized by rashes that sometimes cover much of the body and can include intense, persistent itching and skin dryness, cracking, redness, crusting and oozing. 85% to 90% of patients first develop symptoms before five years of age, which can often continue through adulthood. In 2014, the FDA also granted Dupixent Breakthrough Therapy designation, and after a Priority Review evaluation, it granted Dupixent marketing authorization in March 2017 for the treatment of adults with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. In 2016, the FDA granted Dupixent Breakthrough Therapy designation for adolescent patients aged 12 to 17 years and in March 2019, the FDA extended the marketing authorization to cover this age group. In 2016, the FDA granted Breakthrough Therapy designation for Dupixent for the treatment of severe AD in children aged six months to 11 years. On May 26, 2020, Dupixent was approved as the first biologic medicine for children aged 6 to 11 years with moderate-to-severe AD. Having accepted Dupixent for Priority Review in February 2022, the FDA approved Dupixent on June 7, 2022 for children aged six months to five years with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable, making Dupixent the first biologic medicine to significantly reduce signs and symptoms in children as young as six months. The EC approved Dupixent in September 2017 for use in adults with moderate-to-severe AD who are candidates for systemic therapy, and extended the marketing authorization in August 2019 to include adolescents aged 12 to 17 years. On November 30, 2020, the EC extended the marketing authorization to children aged 6 to 11 years with severe AD and on June 28, 2021, the Dupixent label was updated with long-term data for up to three years, reinforcing the medicine’s well-established safety profile in adults with moderate-to-severe AD. On January 27, 2023 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Dupixent, recommending expanded approval in the EU to treat severe AD in children aged six months to five years who are candidates for systemic therapy. In March 2023, Dupixent was approved by the EC as the first and only targeted medicine for children as young as six months old with severe AD. On January 22, 2018, the Ministry of Health, Labor and Welfare (MHLW) in Japan granted marketing and manufacturing authorization for Dupixent for the treatment of AD in adults not adequately controlled with existing therapies. More recently, on September 25, 2023 Dupixent was approved in Japan to treat patients aged six months and older with moderate-to-severe AD. On June 19, 2020, the National Medical Products Administration (NMPA) in China approved Dupixent for adults for the treatment of moderate-to-severe AD after identifying dupilumab as an overseas medicine regarded as urgently needed in clinical practice, leading to an expedited review and approval process. 22 SANOFI FORM 20-F 2025 PART I ITEM 4. Information on the Company In April 2023, new abstract data from a long-term efficacy open-label study presented at the Revolutionizing Atopic Dermatitis (RAD) 2023 Spring Conference in Washington, DC showed that Dupixent demonstrated robust and sustained efficacy with progressive improvement of AD signs and symptoms in patients with moderate-to-severe AD who completed up to five years of treatment: the longest duration of data for any biologic medicine in this disease. Additionally, the long-term safety data from a 52-week open-label extension study in children aged six months to five years reinforced the well-established safety profile of Dupixent observed across all other approved age groups. These data build on the existing evidence supporting the selective way Dupixent inhibits IL4/IL-13 pathways, both key and central drivers of type 2 inflammation, thereby significantly improving itching and skin lesions and other important measures that impact a patient’s quality of life. The inclusion of the results from the five-year OLE study for adults in the Dupixent label was approved in Europe in June 2023, and in the US by the FDA in October 2023. In March 2023, positive results from the clinical study assessing Dupixent in adults and adolescents with uncontrolled moderate-to-severe atopic hand and foot dermatitis were presented in a late-breaking session, one of more than 20 Dupixent scientific presentations, at the American Academy of Dermatology (AAD) 2023 Annual Meeting. The study, evaluating a biologic for this difficult-to-treat population, met its primary and key secondary endpoints. In August 2023, the clinical section of the Dupixent label in Europe was updated to include the hand and foot dermatitis population. In January 2024, the Dupixent US label was updated with data further supporting use in AD with moderate-to-severe hand and foot involvement. These Phase 3 data are from the first and only study evaluating a biologic specifically for this difficult-to-treat population and have also been added to the Dupixent label in the European Union, with regulatory submissions under way in additional countries. Asthma Dupixent was granted marketing authorization by the FDA in October 2018 as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. In May 2019, the EC approved Dupixent for use as an add-on maintenance treatment in severe asthma patients aged 12 years and older with type 2 inflammation whose symptoms are inadequately reduced by other treatments. In September 2020, new long-term data from a Phase 3 open-label extension study showed sustained improvement in lung function and reduction in severe exacerbations in adults and adolescents with moderate-to-severe asthma. On May 17, 2021, detailed results from a Phase 3 study showed Dupixent significantly reduced severe asthma attacks, and within two weeks rapidly improved lung function in children aged six to 11 years with uncontrolled moderate-to-severe asthma with evidence of type 2 inflammation. Moreover, Dupixent significantly improved overall asthma symptom control and reduced an airway biomarker of type 2 inflammation, called fractional exhaled nitric oxide (FeNO), that plays a major role in asthma. In October 2021, the FDA approved Dupixent as an add-on maintenance treatment for patients aged six to 11 years with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma, thereby bringing a new treatment for children who may be suffering from life-threatening asthma attacks and poor lung function affecting their ability to breathe, which could potentially continue into adulthood. On April 7, 2022, the EC approved Dupixent for use in children aged six to 11 years as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised FeNO, whose symptoms are inadequately reduced with medium to high dose inhaled corticosteroids (ICS) plus another medicine for maintenance treatment. In March 2019, Dupixent was approved in Japan for treating patients aged 12 years and over with severe or refractory asthma whose symptoms are inadequately controlled with existing therapies. In addition, in December 2025, Japan granted marketing and manufacturing authorization for Dupixent for the treatment of bronchial asthma in children aged 6 to 11 years with severe or refractory disease whose symptoms are inadequately controlled with existing therapy. In November 2023, Dupixent received approval in China for treatment of moderate to severe asthma patients aged 12 years and over with type 2 inflammation. In February 2024, topline results from the VESTIGE Phase 4 clinical study were presented at the 2024 American Academy of Allergy, Asthma, and Immunology Annual Meeting. This study evaluated the effects of Dupixent on airway remodeling in adults with uncontrolled moderate-to-severe asthma characterized by an eosinophilic phenotype or those dependent on oral corticosteroids. In 2024, Sanofi initiated a Phase 3 study for children aged two to six years suffering from asthma. This parallel, two-arm Phase 3 study aims to evaluate the efficacy and long-term safety of dupilumab treatment in children with uncontrolled asthma and/or recurrent severe asthmatic wheeze. Chronic rhinosinusitis with nasal polyposis (CRSwNP) CRSwNP is a chronic disease of the upper airway that obstructs the sinuses and nasal passages. It can lead to breathing difficulties, nasal congestion and discharge, reduced or loss of sense of smell and taste, and facial pressure. In June 2019, the FDA approved Dupixent for use with other medicines to treat CRSwNP in adults whose disease is not controlled. In October 2019, the EC approved Dupixent for use as an add-on therapy with intranasal corticosteroids in adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. In March 2020, the Japanese Pharmaceuticals and Medical Devices Agency approved Dupixent as add-on maintenance treatment for adults with inadequately controlled CRSwNP. SANOFI FORM 20-F 2025 23 PART I ITEM 4. Information on the Company In September 2024, the FDA approved Dupixent as an add-on maintenance treatment for adolescent patients aged 12 to 17 years with inadequately controlled CRSwNP, expanding the initial FDA approval in CRSwNP from June 2019 for patients aged 18 years and older. The FDA evaluated Dupixent for this expanded indication under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions. Eosinophilic esophagitis (EoE) EoE is a chronic and progressive inflammatory disease that damages the esophagus and prevents it from working properly; swallowing even small amounts of food can be a painful and worrisome choking experience. In severe cases, a feeding tube may be the only option to ensure proper calorific intake and adequate nutrition. As the disease progresses, patients may continue to experience symptoms despite multiple treatments. On September 14, 2020, the FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients aged 12 years and older with EoE, and subsequently accepted the file for Priority Review on April 4, 2022. On May 20, 2022, the FDA approved Dupixent to treat patients with EoE aged 12 years and older. With this approval, Dupixent became the first and only medicine specifically indicated to treat EoE in the US. On December 16, 2022, the European Medicines Agency (EMA)'s CHMP adopted a positive opinion, recommending the approval of dupilumab in the EU to treat adults and adolescents with EoE. On January 30, 2023, the EC expanded the marketing authorization for Dupixent in the EU to include the treatment of EoE in adults and adolescents aged 12 years and older. On July 14, 2022, a Dupixent Phase 3 study showed positive results in children aged one to 11 years with EoE, making this the fifth pediatric pivotal study across three type 2 inflammatory diseases to reinforce the well-established efficacy and safety profile of Dupixent. In January 2024, Dupixent was approved by the FDA for the treatment of adult and pediatric patients aged one year or older, weighting at least 15 kilograms, with EoE. The EoE pediatric indication was approved in the EU in November 2024. Prurigo nodularis (PN) Prurigo nodularis is a chronic, debilitating skin disease with underlying type 2 inflammation and has one of the highest impacts on a patient’s quality of life among inflammatory skin diseases due to the extreme itching it causes. People with PN experience intense, persistent itching, with thick skin lesions (called nodules) that can cover most of the body. The disease is often painful – with burning, stinging and tingling of the skin – and can negatively affect mental health, daily living activities and social interactions. High-potency topical steroids are commonly prescribed but are associated with safety risks if used long-term. The FDA evaluated the Dupixent application for PN under Priority Review on May 31, 2022. On September 29, 2022, the FDA approved Dupixent for the treatment of adult patients with PN. With this approval, Dupixent became the first and only medicine specifically indicated to treat PN in the US. The FDA approval was based on data from two Phase 3 studies evaluating the efficacy and safety of Dupixent in adults with PN. Efficacy in these studies assessed the proportion of subjects with clinically meaningful reduction in itching, clearing of skin, or both. On December 15, 2022, the EC expanded the marketing authorization for Dupixent in the EU to treat adults with moderate-to-severe PN who are candidates for systemic therapy, after the previous positive recommendation on November 11, 2022. The Dupixent PN indication was approved in Japan on June 26, 2023, and in China on September 22, 2023. Chronic spontaneous urticaria (CSU) CSU is a chronic inflammatory skin disease characterized by the sudden onset of hives on the skin and/or swelling deep under the skin. Despite standard-of-care treatment, people with CSU often experience symptoms including a persistent itching or burning sensation, which can be debilitating and significantly impact quality of life. Swelling often occurs on the face, hands and feet, but can also affect the throat and upper airways. On July 29, 2021 a pivotal Phase 3 study evaluating Dupixent in patients with moderate-to-severe CSU met its primary endpoints and all key secondary endpoints at 24 weeks. Adding Dupixent to standard-of-care antihistamines significantly reduced itching and hives for biologic-naive patients, compared to those treated with antihistamines alone (placebo) in Study A (the first of three studies) of the LIBERTY CUPID clinical program. Study B evaluated Dupixent in adults and adolescents who remain symptomatic despite standard-of-care antihistamine treatment and are intolerant or incomplete responders to an anti-IgE therapeutic (omalizumab). Although positive numerical trends in reducing itching and hives were observed, the study met futility criteria in the pre-specified interim analysis. Further analysis following blinded completion of the study demonstrated that Dupixent met the EU primary endpoint (UAS7 at week 24). The safety data were generally consistent with the known safety profile of Dupixent in its approved indications. In December 2022, Dupixent was submitted to the FDA for the CSU indication. In October 2023, the FDA issued a Complete Response Letter (CRL) stating that additional efficacy data were required to support approval; it did not identify any issues with safety or manufacturing. Accordingly, a third clinical study (Study C) was initiated to provide additional efficacy data. In September 2024, the Dupixent confirmatory Phase 3 study (LIBERTY-CUPID Study C) met the primary and key secondary endpoints for the investigational treatment of patients with uncontrolled, biologic-naive CSU receiving background therapy with antihistamines. This positive study confirmed results from Study A, but failed to meet the ex-EU primary endpoint (ISS at week 24). Earlier in 2024, Japan was the first country in the world to approve and launch Dupixent for adult and adolescent CSU patients based on the results from Study A (February 2024), followed by approvals in the United Arab Emirates (September 2024), Brazil (November 2024), the US (April 2025), and the Kingdom of Saudi Arabia (KSA) (October 2025). 24 SANOFI FORM 20-F 2025 PART I ITEM 4. Information on the Company Chronic obstructive pulmonary disease (COPD) COPD is a progressive respiratory disorder that damages the lungs and reduces lung function, making it the fourth leading cause of death worldwide. Key symptoms include persistent coughing, excessive mucus production, and shortness of breath, which can significantly affect daily activities and contribute to sleep disturbances, anxiety, and depression. COPD also imposes a major health and economic burden due to frequent acute exacerbations, often requiring treatment with systemic corticosteroids and/or antibiotics, and hospitalizations when severe. Exacerbations are also associated with lung function decline and worsened clinical burden and outcomes in a vicious cycle. While smoking and exposure to harmful particles are primary risk factors, the disease may still progress in those who have quit smoking. Around 50% of COPD patients continue to experience exacerbations despite receiving triple inhaled therapy. In the US, approximately 300,000 individuals have inadequately controlled COPD with Type 2 Inflammation (also known as eosinophilic phenotype), a subgroup prone to a 30% increase in exacerbations and a higher risk of COPD-related hospital readmissions within a year. On July 3, 2024, following a positive review by the EMA, the EC approved Dupixent as an add-on maintenance treatment for adults with uncontrolled COPD characterized by elevated blood eosinophils. This approval covers patients already on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or those on a LABA/LAMA combination if ICS is unsuitable. The EC was the first regulatory agency worldwide to grant approval for Dupixent in COPD patients. On September 10, 2024, a pooled analysis from the BOREAS and NOTUS Phase 3 studies showed that Dupixent reduced exacerbations and improved lung function and quality of life compared to placebo in adults with uncontrolled COPD and evidence of type 2 inflammation (i.e. raised blood eosinophils). The results were presented for the first time, in collaboration with Regeneron, at the 2024 European Respiratory Society (ERS) International Congress. On September 27, 2024, the NMPA in China also approved Dupixent as an add-on treatment for adults with uncontrolled COPD and raised blood eosinophils. This approval similarly covers patients on combinations of ICS, LABA, and LAMA, or LABA and LAMA if ICS is not appropriate. Dupixent has now been approved for the treatment of COPD in over 30 countries, including the 27 EU member states. On September 27, 2024, the FDA approved Dupixent as the first biologic treatment for COPD in the US. This approval, which applies to adults with inadequately controlled COPD and an eosinophilic phenotype, was based on two pivotal Phase 3 studies showing significant reductions in exacerbations and improvements in lung function and quality of life compared to placebo. Dupixent has become the leading biologic in new-to-brand prescriptions across all its FDA-approved indications and is the most prescribed biologic by US pulmonologists. As of October 2025, Dupixent had been approved for COPD in 53 countries and launched across 17 markets including the US, Germany, China and Japan. Bullous pemphigoid (BP) BP is a chronic, debilitating and relapsing skin disease. It affects approximately 52,000 adults in the US, and is characterized by intense itch and blisters, reddening of the skin and painful lesions. It can be chronic and relapsing with underlying type 2 inflammation, and primarily affects elderly patients. The blisters and rash can form over much of the body and cause the skin to bleed and crust, resulting in patients being more prone to infection and affecting their daily functioning. Available treatment options are limited and can add to overall disease burden by suppressing a patient’s immune system. In June 2025, Dupixent (dupilumab) was approved in the US as the only targeted medicine to treat patients with BP. The FDA approval was based on data from the pivotal Phase 2/3 ADEPT trial that evaluated the efficacy and safety of Dupixent compared to placebo in adults with moderate-to-severe BP. ADEPT was a randomized, Phase 2/3, double-blind, placebo-controlled trial evaluating the efficacy and safety of Dupixent in 106 adults with moderate-to-severe BP for a 52-week treatment period. After randomization, patients received Dupixent or placebo every two weeks after an initial loading dose, along with oral corticosteroids (OCS) treatment. During treatment, OCS taper was initiated after patients experienced two weeks of sustained control of disease activity. OCS tapering could start between four to six weeks after randomization and was continued if disease control was maintained, with the intent of completion by 16 weeks. After OCS tapering, patients were only treated with Dupixent or placebo for at least 20 weeks, unless rescue treatment was required. The primary endpoint evaluated the proportion of patients achieving sustained disease remission at 36 weeks. Sustained disease remission was defined as complete clinical remission with completion of OCS taper by 16 weeks without relapse after completion of the OCS taper and no rescue therapy use during the 36-week treatment period. Relapse was defined as the appearance of three or more new lesions a month, or at least one large lesion or urticarial plaque (greater than 10 cm in diameter), that did not heal within a week. Rescue therapy could include treatment with high-potency topical corticosteroids, OCS (including increase of OCS dose during the taper or re-initiation of OCS after completion of the OCS taper), systemic non-steroidal immunosuppressive medications or immunomodulating biologics. SANOFI FORM 20-F 2025 25 PART I ITEM 4. Information on the Company Life cycle management Dupixent is currently being evaluated in clinical development programs for diseases that are driven by type 2 inflammation. These include chronic pruritis of unknown origin (CPUO), eosinophilic gastroenteritis (EoG), ulcerative colitis (UC) and Lichen Simplex Chronicus (LSC). See “— B.4. Global research & development.” In August 2025, a supplemental biologics license application (sBLA) for Dupilumab for the Allergic Fungal Rhinosinusitis (AFRS) indication, with a request for Priority Review, was submitted to the FDA and subsequently accepted for priority review in November 2025 . The target action date for the FDA decision is February 28, 2026. Dupixent is developed and commercialized in collaboration with Regeneron. For additional information on the collaboration, see “Item 5. Operating and Financial Review and Prospects — A.1.7. Financial Presentation of Alliances — Alliance Arrangements with Regeneron Pharmaceuticals, Inc. (Regeneron).” Kevzara Kevzara (sarilumab) is a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R) and has been shown to inhibit IL-6R mediated signaling. IL-6 is a multi-functional cytokine that acts as a critical signaling node in the complex pro-inflammatory cytokine network that underpins rheumatoid arthritis (RA), Polymyalgia rheumatica (PMR) and other immune-mediated diseases. Kevzara has been approved for RA in 39 countries. For the PMR indication, Kevzara has been approved in the US, EU, UK, Canada, and Israel. In 2024, the FDA approved Kevzara for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) , followed by the EU and UK in 2025. Kevzara is developed and commercialized in collaboration with Regeneron. For additional information, see “Item 5. Operating and Financial Review and Prospects — A.1.7. Financial Presentation of Alliances — Alliance Arrangements with Regeneron Pharmaceuticals, Inc. (Regeneron).” Rheumatoid arthritis (RA) RA is a chronic inflammatory autoimmune disease causing inflammation, pain, and eventually joint damage and disability. Kevzara is approved in 39 countries for use in combination with disease modifying anti-rheumatic drugs (DMARDs) or as monotherapy for the treatment of moderately to severely active RA in adult patients who respond inadequately or are intolerant to DMARDs or tumour necrosis factor (TNF) antagonist. In May 2017, the FDA approved Kevzara for the treatment of adult patients with moderately to severely active RA who have responded inadequately to, or who are intolerant to one or more DMARDs. In June 2017, the EC granted marketing authorization for Kevzara in combination with methotrexate for the treatment of moderately to severely active RA in adult patients who have responded inadequately to – or who are intolerant to – one or more DMARDs. Kevzara can be given as monotherapy in case of intolerance to methotrexate or when treatment with methotrexate is inappropriate. In September 2017, Kevzara obtained manufacturing and marketing approval in Japan as a treatment for RA not responding well to conventional treatments. Polymyalgia rheumatica (PMR) PMR is a rheumatic inflammatory disorder characterized by pain and stiffness around the neck, shoulder and hip areas that leads to significant decline in quality of life. Kevzara is approved for the treatment of adult patients with PMR in the US, Israel, EU, UK and Canada. In February 2023, the FDA approved Kevzara for the treatment of adult patients with PMR who have had an inadequate response to corticosteroids or who cannot tolerate a corticosteroid taper. In November 2024, the EC granted marketing authorization for Kevzara for the treatment of PMR in adult patients who have had an inadequate response to corticosteroids, or who experience a relapse on a corticosteroid taper. Polyarticular Juvenile Idiopathic Arthritis（pJIA） Juvenile idiopathic arthritis (JIA) is an umbrella-term describing a heterogeneous group of conditions characterized by chronic arthritis beginning before the age of 16 years, persisting for at least 6 weeks, and having no other identifiable cause. Polyarticular JIA includes a blend of patients with a wide spectrum of etiologic risk factors, unique disease course, and therapeutic challenges. In June 2024, the FDA approved Kevzara for treatment of active pJIA in patients who weigh 63 kilograms or more. In January 2025, the EC granted marketing authorization for Kevzara for the treatment of active pJIA in patients aged two years and older. Kevzara is indicated for those who have not responded adequately to previous therapies with conventional synthetic DMARDs. Kevzara may be used as monotherapy or in combination with methotrexate. The treatment is administered as an injection under the skin once every two weeks, and is effective in reducing inflammation and improving symptoms associated with pJIA. 26 SANOFI FORM 20-F 2025 PART I ITEM 4. Information on the Company Rare diseases Cerezyme Cerezyme (imiglucerase) is an enzyme replacement therapy (ERT) used to treat Gaucher disease, a chronic, inherited, progressive and potentially life-threatening lysossomal storage disorder (LSD). Gaucher disease is caused by a deficiency of the enzyme glucocerebrosidase; this causes a fatty substance called glucosylceramide (also called GL-1) to build up in certain areas of the body including the spleen, liver, and bone. Gaucher disease exhibits diverse manifestations, a broad range of onset of symptoms, and a wide clinical spectrum of disease severity. It is estimated that Gaucher disease occurs in approximately one in 120,000 newborns in the general population and one in 850 in the Ashkenazi Jewish population worldwide, but incidence and patient severity vary among regions. Cerezyme has been marketed in the US since 1994, in the EU since 1997, in Japan since 1998 and in China since 2008, and is approved to treat type 1 Gaucher disease in more than 85 countries. It has also been approved to treat the systemic symptoms of type 3 Gaucher disease in most non-US markets, including the EU and Japan. Cerdelga Cerdelga (eliglustat) is the first and only first-line oral therapy for Gaucher disease type 1 adult patients. A potent, highly specific ceramide analog inhibitor of GL-1 synthesis with broad tissue distribution, Cerdelga has demonstrated efficacy in the treatment of naive Gaucher disease patients and in patients who switch from enzyme replacement therapy. Cerdelga has been approved to treat type 1 Gaucher disease in the US (2014), and in the EU and Japan (2015). It is also in development for the treatment of type 1 Gaucher disease in pediatric patients. See “— B.4. Global Research & Development.” Myozyme and Lumizyme Myozyme (alglucosidase alfa) is an ERT used to treat both Infantile Onset and Late Onset Pompe disease (IOPD and LOPD). Pompe disease is an inherited, progressive and often fatal neuromuscular disease, caused by a genetic deficiency or dysfunction of the lysosomal enzyme acid alpha-glucosidase (GAA) that results in the build-up of glycogen in the muscles’ cells. For IOPD, symptoms begin within a few months of birth and there are impacts on the heart in addition to causing skeletal muscle weakness. Other symptoms include difficulties breathing, frequent chest infections, problems feeding that result in failure to gain weight as expected, and failure to meet certain developmental milestones. Patients with LOPD typically present symptoms any time after the first year of life to late adulthood and rarely manifest cardiac problems. The hallmark symptom of LOPD is skeletal muscle weakness, which often leads to walking disability and reduced respiratory function. Patients often require wheelchairs to assist with mobility and may require mechanical ventilation to help with breathing. Pompe disease occurs in approximately one in 40,000 newborns worldwide, but incidence and patient severity vary among regions. Myozyme was first approved in 2006 in the EU and has since been approved in more than 80 countries. In the US, alglucosidase alfa has been marketed as Lumizyme since 2010. Nexviazyme/Nexviadyme Nexviazyme/Nexviadyme (avalglucosidase alfa-ngpt) is a novel mannose-6-phosphate (M6P) enriched ERT treatment designed as a monotherapy for the entire spectrum of infantile-onset and late-onset Pompe disease (IOPD, LOPD), including patients who have changed treatments and naive patients, who have not received treatment previously. Nexviazyme/Nexviadyme is scientifically designed to specifically target the M6P receptor, the key pathway for ERT, to effectively clear glycogen build-up in muscle cells. It helps replace the GAA enzyme for people whose bodies do not produce enough. Investment in the clinical development of Nexviazyme is continuing, with an ongoing Phase 3 study in treatment-naive IOPD patients aged less than 12 months. Nexviazyme/Nexviadyme is administered as a monotherapy every two weeks. Nexviazyme was first approved in the US by the FDA on August 6, 2021 for LOPD patients aged one year and older. On June 24, 2022, the EC granted marketing authorization for Nexviadyme as a potential new standard of care for the long-term treatment of both LOPD and IOPD. Nexviazyme/Nexviadyme has been approved in more than 59 countries and successfully launched in 32 countries including the US, Germany, the UK, other European markets, Japan and Australia. In all launched markets, the vast majority of eligible patients are currently being treated with Nexviazyme/Nexviadyme. Fabrazyme Fabrazyme (agalsidase beta) is an ERT used to treat Fabry disease (FD). FD is a multisystemic, progressive, X-linked inherited disorder of glycosphingolipid metabolism due to deficient or absent lysosomal α-galactosidase A activity resulting in progressive globotriaosylceramide (GL-3) accumulation in the lysosomes of various tissues. FD affects both genders. With age, progressive organ damage develops, leading to potentially life-threatening renal, cardiac and/or cerebrovascular complications. FD is characterized by different symptom severities and rates of progression, ranging from classic disease with early symptom onset to non-classic disease with cardiac and/or renal complications later in life. FD is seen in all racial and ethnic groups and is an under-diagnosed condition. Prevalence estimates vary across regions. Classic FD mutations are estimated to be approximately 1:40,000 in males with more wide-ranging estimates for non-classic in both males and females. Fabrazyme has been marketed in the EU since 2001 and in the US since 2003 and is approved in more than 70 countries. SANOFI FORM 20-F 2025 27 PART I ITEM 4. Information on the Company Aldurazyme Aldurazyme (laronidase) is the only approved ERT for mucopolysaccharidosis type 1 (MPS I), an inherited lysosomal storage disorder caused by a deficiency of alpha-L-iduronidase, a lysosomal enzyme normally required for the breakdown of certain complex carbohydrates known as glycosaminoglycans (GAGs). MPS I is multi-systemic, and children with MPS I are described as having either a severe or attenuated form of the disorder based on age of onset, severity of symptoms, rate of disease progression and whether there is early and direct involvement of the brain. MPS I occurs in approximately one per 100,000 live births worldwide, but incidence and patient severity vary among regions. Sanofi markets Aldurazyme in the EU and the US (since 2003) and in more than 75 other countries. Xenpozyme Xenpozyme (olipudase alfa) is an ERT designed to replace deficient or defective acid sphingomyelinase (ASMD), an enzyme that allows for the breakdown of the lipid sphingomyelin. In individuals with ASMD, an insufficiency of the ASM enzyme means sphingomyelin is poorly metabolized, potentially leading to lifelong accumulation in and damage to multiple organs. The significance of the unmet need that Xenpozyme addresses has been recognized by Japan’s PMDA with Sakigake designation, by the EU with PRIME designation, and by the FDA with Breakthrough designation. Xenpozyme was approved first in Japan on March 28, 2022, followed by Europe on June 24, 2022 and the US on August 31, 2022. Xenpozyme is the first and only ERT for the treatment of non-central nervous system manifestations of ASMD, with demonstrated improvements in hepatosplenomegaly, pulmonary, liver and hematologic function, dyslipidemia, and growth (children only) in clinical studies of adults and children with ASMD. Xenpozyme is given as an intravenous infusion once every two weeks, and the dose is based on body weight. Xenpozyme has to date been commercialized in 26 countries, however only 15 of those have full reimbursement by payers. By 2030, it is anticipated that Xenpozyme will have been launched in many additional markets worldwide. Wayrilz Wayrilz (rilzabrutinib) is the first oral reversible Bruton’s tyrosine kinase (BTK) inhibitor for immune thrombocytopenia (ITP) that helps address the root cause of disease through multi-immune modulation. BTK, expressed in B cells, macrophages and other innate immune cells, plays a critical role in multiple immune-mediated disease processes and inflammatory pathways. With the application of Sanofi’s TAILORED COVALENCY technology, Wayrilz can selectively inhibit the BTK target while potentially reducing the risk of off-target side effects. Wayrilz is being studied across a variety of rare or inflammatory diseases, including warm autoimmune hemolytic anemia (wAIHA), IgG4-related disease (IgG4-RD), and sickle cell disease (SCD). These additional indications are currently under investigation and have not been approved by regulatory authorities. ITP is a disease of complex immune dysregulation that causes low platelet counts (less than 100,000/μL), resulting in a variety of bleeding symptoms and high risk of thromboembolism. Beyond bruising and bleeding, which can include potentially life- threatening episodes like intracranial hemorrhage, people living with ITP may experience reduced quality of life, including physical fatigue and cognitive impairment. The FDA has approved Wayrilz for adults with persistent or chronic ITP who have had an insufficient response to a previous treatment. The approval was based on the pivotal LUNA 3 Phase 3 study, in which Wayrilz met the primary and secondary endpoints, showing a positive impact on sustained platelet counts and other ITP symptoms, like fatigue. Wayrilz has also been approved in the United Arab Emirates. The EC has approved Wayrilz as a new treatment for ITP in adult patients who are refractory to other treatments, following a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). Wayrilz has received Fast Track and Orphan Drug Designations (ODD) from the FDA for ITP, with similar orphan designations in Japan and the EU. Most recently, the FDA has granted Wayrilz an ODD for three additional rare diseases: wAIHA, IgG4-RD, and SCD. Wayrilz has also received FDA Fast Track Designation in IgG4-RD and wAIHA, and European Medicines Agency orphan designation in IgG4-RD. ALTUVIIIO ALTUVIIIO (Antihemophilic Factor Recombinant, Fc-VWF-XTEN Fusion Protein) is a first-in-class high-sustained factor VIII therapy that is designed to extend protection from bleeds with once-weekly prophylactic dosing for adults and children with hemophilia A. Hemophilia A is a rare, x-linked genetic bleeding disorder characterized by a deficiency of functional coagulation factor VIII, resulting in a prolonged patient plasma-clotting time. As a consequence, people with hemophilia A bleed for a longer time than normal. ALTUVIIIO temporarily replaces the missing coagulation factor VIII by intravenous injection. In adults and adolescents, it is the first factor VIII therapy that has been shown to break through the von Willebrand factor ceiling, which imposes a half-life limitation on earlier generation factor VIII therapies. ALTUVIIIO builds on innovative Fc fusion technology by adding a region of von Willebrand factor and XTEN polypeptides to extend its time in circulation. ALTUVIIIO was first approved in February 2023 by the FDA, which had previously granted Breakthrough Therapy designation in May 2022 (the first factor VIII therapy to receive this designation); fast-track designation in February 2021; and Orphan Drug designation in 2017. ALTUVIIIO has since been approved the by regulatory authorities in Canada, Japan, Taiwan, Macau and Hong Kong, and has been commercialized in Japan and Taiwan. The European Commission (EC) granted Orphan Drug designation in June 2019 and a marketing authorization application was filed with the European Medicines Agency (EMA) in May 2023. ALTUVOCT (the brand name of ALTUVIIIO in Europe) received EC marketing authorization in June 2024. 28 SANOFI FORM 20-F 2025 PART I ITEM 4. Information on the Company ALTUVIIIO is developed and commercialized in collaboration with Swedish Orphan Biovitrum AB (Sobi), whose territories include Europe, Russia, the Middle East, and some countries in North Africa. Eloctate Eloctate (Antihemophilic Factor Recombinant, Fc fusion protein) is an extended half-life factor VIII therapy clotting-factor therapy to control and prevent bleeding episodes in adults and children with hemophilia A. In the US, it is indicated for use in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. Eloctate temporarily replaces the missing coagulation Factor VIII by intravenous injection. We market Eloctate primarily in the US (since 2014), Japan, Canada, Australia, South Korea, Taiwan and Hong Kong/Macau. Eloctate is developed and commercialized in collaboration with Sobi, whose territories include Europe, Russia, the Middle East, and some countries in North Africa. Alprolix Alprolix (coagulation Factor IX recombinant, Fc fusion protein) is an extended half-life factor IX clotting-factor therapy to control and prevent bleeding episodes in adults and children with hemophilia B. In the US, it is indicated for use in adults and children with hemophilia B for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. Hemophilia B is a rare, x-linked genetic bleeding disorder characterized by a deficiency of functional coagulation Factor IX, resulting in a prolonged patient plasma-clotting time. As a consequence, people with hemophilia B bleed for a longer time than normal. Alprolix temporarily replaces the missing coagulation Factor IX by intravenous injection. We market Alprolix primarily in the US (since 2014), Japan, Canada, Australia, New Zealand, South Korea, Taiwan and Hong Kong/Macau. Alprolix is developed and commercialized in collaboration with Sobi, whose territories include Europe, Russia, the Middle East, and some countries in North Africa. Qfitlia Qfitlia (fitusiran) is a first-in-class antithrombin lowering therapy indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without factor VIII or IX inhibitors. Hemophilia A and B are rare, x-linked genetic bleeding disorders characterized by a deficiency of functional coagulation factor VIII or IX, respectively, resulting in a prolonged patient plasma-clotting time. Consequently, people with hemophilia A or B bleed for a longer time than normal. Qfitlia is a small interfering RNA therapeutic designed to lower antithrombin, a protein that inhibits blood clotting, with the goal of promoting thrombin generation to rebalance hemostasis and prevent bleeds. Qfitlia utilizes Alnylam Pharmaceutical, Inc.’s ESC-GalNAc conjugate technology, which enables subcutaneous dosing every other month.  It is administered via subcutaneous injection with a convenient, prefilled pen for the 50 mg dose. Qfitlia has received approval from the FDA, which had previously granted it Breakthrough Therapy designation, Fast Track designation and Orphan Drug designation. Qfitlia has also been approved by regulatory authorities in the UAE, Macao and China. Qfitlia is sold under license from Alnylam Pharmaceuticals, Inc. Cablivi Cablivi (caplacizumab) is a bivalent anti-von Willebrand Factor (vWF) NANOBODY® VHH for the treatment of patients experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP). Depending on the country, Cablivi is approved in adults only or in adults and pediatric population aged 12 years and above. Cablivi is the first and a best-in-class treatment reducing aTTP morbidities and mortality to improve and save lives. Cablivi treatment results in the inhibition of microthrombi formation and preventing organ damage. Acquired thrombotic thrombocytopenic purpura is an ultra-rare (3.5-4.5 episodes per million of population), life-threatening, autoimmune-based blood clotting disorder characterized by extensive clot formation in small blood vessels throughout the body, leading to severe thrombocytopenia (very low platelet count); microangiopathic hemolytic anemia (loss of red blood cells through destruction); ischemia (restricted blood supply to parts of the body); and widespread organ damage, especially in the brain and heart. Cablivi was granted marketing authorization in Europe by the EC in September 2018; in the US by the FDA in February 2019; and in Japan by the Japanese Pharmaceutical and Medical Devices Agency (PMDA) in September 2022. Cablivi is currently commercially available in 28 countries including the US, the majority of European countries, Switzerland, Brazil, Colombia, Japan and five Greater Gulf region states. Recently, Cablivi obtained Regulatory BLA approval in China following priority review. Additional commercial launches are ongoing. Cablivi was developed by Ablynx, a Sanofi company since mid-2018. SANOFI FORM 20-F 2025 29 PART I ITEM 4. Information on the Company Ayvakit/Ayvakyt Ayvakit/Ayvakyt (generic name: avapritinib) is a small-molecule tyrosine kinase inhibitor (TKI) that works by selectively inhibiting mutant forms of KIT (D816V mutation) and PDGFRA (platelet-derived growth factor receptor alpha; D842V mutation) kinases. Ayvakit/Ayvakyt has been indicated for treatment of adults with unresectable, metastatic gastrointestinal stromal tumors (GIST), and with advanced and indolent systemic mastocytosis (SM). The FDA has granted three breakthrough therapy designations to Ayvakit. The medicine has received orphan drug designations from the FDA and orphan medicinal product designations from the EMA for the treatment of advanced and indolent systemic mastocytosis and unresectable or metastatic GIST. Ayvakit was first approved by the FDA in January 2020 for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations. PDGFRA exon 18 mutations, including the PDGFRA D842V mutation, are primary drivers of disease in a subset of patients with GIST. Ayvakit is the only approved medicine for patients with PDGFRA D842V-driven GIST. The medicine received EMA conditional marketing authorization as Ayvakyt for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA D842V mutation in September 2020. Ayvakit was FDA approved for the treatment of adults with advanced SM in June 2021 and indolent SM (ISM) in May 2023. The medicine received EMA approval under the brand name Ayvakyt for the treatment of adults with advanced SM, including aggressive SM (ASM), SM with an associated hematological neoplasm (SM-AHN) or mast cell leukemia (MCL), after at least one systemic therapy, and adults with ISM with moderate to severe symptoms inadequately controlled on symptomatic treatment. It is the only medicine approved across the spectrum of advanced and indolent systemic mastocytosis (SM). For patients with SM, the KIT D816V mutation leads to uncontrolled proliferation and activation of mast cells, resulting in chronic, severe and often unpredictable symptoms across multiple organ systems. In addition, advanced SM is associated with organ damage due to mast cell infiltration and poor survival. Ayvakit was developed and is marketed by Blueprint Medicines, a Sanofi company. Globally, Ayvakit is approved for one or more indications in more than 35 countries worldwide, including China where it has been developed and commercialized by CStone Pharmaceuticals. Neurology Aubagio Aubagio (teriflunomide) is used to help manage multiple sclerosis (MS). This small molecule agent, taken once daily, works by reducing inflammation and modulating the immune system to prevent the immune attacks that cause MS symptoms. Aubagio is approved in over 80 countries, including the US (since September 2012) for relapsing forms of MS; the EU (since August 2013) for adult relapsing remitting MS; and China (since July 2018). In June 2021, the EC approved Aubagio for the treatment of pediatric patients aged 10 to 17 years with relapsing-remitting multiple sclerosis (RRMS). In 2017, Sanofi reached settlement with all 20 generic Aubagio ANDA first filers, granting royalty-free licenses to enter the US market on March 12, 2023. In the EU, the first generic competitors to Aubagio became available in September 2023. Oncology Sarclisa Sarclisa (isatuximab) is a differentiated anti-CD38 monoclonal antibody that targets a specific epitope on CD38, exerting antitumor effects through multiple mechanisms of action. It is approved in nearly 60 countries for four indications in both newly diagnosed (NDMM) and relapsed refractory multiple myeloma (RRMM). Sarclisa was first approved in the US in March 2020 in combination with pomalidomide and dexamethasone for the treatment of adults with RRMM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. In Europe, the EC granted approval in May 2020 for Sarclisa in combination with pomalidomide and dexamethasone for the treatment of adult patients with RRMM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. In early 2025, Sarclisa in combination with pomalidomide and dexamethasone was approved by the NMPA in China for the treatment of adult patients with MM who have received at least one prior line including lenalidomide and proteasome inhibitor, representing the first indication of Sarclisa approved in China. In March 2021, Sarclisa received approval in the US for a label extension in combination with carfilzomib and dexamethasone for the treatment of adults with RRMM who have received one to three prior lines of therapy. In Europe, the EC approved this combination in April 2021 for the treatment of adult patients with MM who have received at least one prior therapy. The Japanese MHLW granted approval for Sarclisa in November 2021 in combination with carfilzomib and dexamethasone, in combination with dexamethasone, and as monotherapy for RRMM patients. Sarclisa was approved in the US in September 2024, in Europe in January 2025, and as the second indication in China in January 2025 in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adults with NDMM who are not eligible for autologous stem cell transplant (ASCT). In July 2025, Sarclisa received approval in Europe in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the induction treatment of adult patients with NDMM who are eligible for ASCT. The Phase 3 IRAKLIA study investigating a new subcutaneous (SC) formulation with an on-body injector (OBI) was initiated in the second half of 2022 in over 20 countries. The study has reported positive results, meeting its co-primary endpoints. This new formulation is currently under regulatory review with agencies worldwide. 30 SANOFI FORM 20-F 2025 PART I ITEM 4. Information on the Company Finally, Sarclisa is currently being investigated in multiple clinical studies, including trials in smoldering multiple myeloma, as a stand-alone maintenance indication, and in combination with several innovative agents in MM through an umbrella Phase 1/2 study. Jevtana Jevtana (cabazitaxel), a chemotherapy drug and cytotoxic agent, is a semi-synthetic second-generation taxane that prevents many cancer cells from dividing, which ultimately results in destroying many such cells. It is approved in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. Jevtana was granted marketing authorization by the FDA in June 2010, by the EC in March 2011, and in Japan in July 2014. The medicine is marketed in over 75 countries. In Europe, generic competition started for Jevtana from the end of March 2021. In the US, the Jevtana composition of matter patent expired in September 2021. Sanofi pursued patent litigation under the US Hatch-Waxman Act against generic manufacturers. Most cases were settled. Sanofi went to trial against the remaining defendant, Sandoz, on one of the patents in January 2023; see Note D.22.b. to the consolidated financial statements, included at Item 18. of this annual report. The district court issued a final judgment in favor of Sanofi; on August 2, 2023, Sandoz appealed to the Court of Appeals for the Federal Circuit. On October 5, 2023, Sanofi and Sandoz filed a joint stipulation voluntarily dismissing Sandoz’s Appeal, bringing this matter to conclusion. Fasturtec/Elitek Fasturtec/Elitek is used for the management of plasma uric levels in patients with leukemia, lymphoma, and solid tumor malignancies receiving anticancer therapies. Other medicines Lantus Lantus (insulin glargine 100 units/mL) is a long-acting analog of human insulin, indicated for once-daily administration for the treatment of diabetes mellitus in adults, adolescents and children aged two years and above. Approved in the US and the EU in 2000 and in Japan in 2008, Lantus is available in over 130 countries. Two insulin glargine biosimilars are available in the US and two in European markets. Toujeo Toujeo (insulin glargine 300 units/mL) is a long-acting analog of human insulin, indicated for the treatment of diabetes mellitus in adults. Toujeo has been granted marketing authorization by the FDA (February 2015), the EC (April 2015), and the MHLW in Japan, where its approved brand name is Lantus XR (July 2015). Toujeo has been launched in over 60 countries, including China since 2020. In January 2020, the EC approved an expansion of the indication to include the treatment of diabetes in adolescents and children (aged six years and above). Toujeo is available in Toujeo Solostar, a disposable prefilled pen which contains 450 units of insulin glargine and requires one-third of the injection volume to deliver the same number of insulin units as Lantus Solostar. In the US (since 2018) and the EU (since 2019), Toujeo is also available in a disposable prefilled pen which contains 900 units of insulin glargine. In India, Toujeo is also available in a dedicated 450-unit cartridge in combination with a dedicated reusable pen (TouStar). Lovenox/Clexane Lovenox or Clexane (enoxaparin sodium) is a low molecular weight heparin (LMWH) indicated for the prophylaxis and treatment of venous thromboembolism and for acute coronary syndrome. In the US, enoxaparin generics are available, while biosimilar enoxaparin medicines have gradually become available across various countries in Europe and the Rest of the World region, including China. Lovenox or Clexane is marketed in over 100 countries. Plavix/Iscover Plavix or Iscover (clopidogrel bisulfate) is a platelet adenosine diphosphate (ADP) receptor antagonist, indicated for preventing atherothrombotic events in patients with a history of recent myocardial infarction (MI), recent ischemic stroke or established peripheral arterial disease (PAD), and for patients with acute coronary syndrome (ACS). Plavix is also indicated in combination with acetylsalicylic acid (ASA) for the prevention of atherothrombotic and thromboembolic events in atrial fibrillation, including stroke. CoPlavix/DuoPlavin, a fixed-dose combination of clopidogrel bisulfate and ASA, is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome who are already taking both clopidogrel and ASA. Several clopidogrel bisulfate generics have been launched in most markets. Plavix or Iscover are available in over 110 countries. Sanofi is involved in two Plavix medicine lawsuits. See Note D.22.c. to our consolidated financial statements, included at Item 18. of this annual report. Rezurock Rezurock (belumosudil) is a first-in-class selective ROCK2 (rho-associated coiled-coil–containing protein kinase-2) inhibitor. It was approved in July 2021 by the FDA for the treatment of adult and pediatric patients aged 12 years and older with chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy. In addition to robust adoption in the US, Rezurock has been approved by health authorities in 20 countries. It is marketed in Japan, South Korea and Thailand by partner Romeck Pharma. Early Access or Managed Access Programs are available in 28 countries. Rezurock has become the standard of care treatment for chronic GVHD in the indicated setting across launched markets, further exemplified by significant SANOFI FORM 20-F 2025 31 PART I ITEM 4. Information on the Company uptake in China where over 8,600 patients have been prescribed Rezurock since the NRDL listing in January 2025. On January 30, 2025, Sanofi received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on conditional marketing authorization, following a re-examination of Rezurock for the treatment of chronic GVHD in late line therapy. This represents a significant milestone in addressing the high unmet medical needs of EU patients living with chronic GVHD. Sanofi is currently developing an oral suspension to support pediatric studies. The pivotal Phase 3 study (ROCKaspire) for Rezurock is currently enrolling patients for the treatment of chronic lung allograft dysfunction (CLAD) post bilateral lung transplant. Sanofi has discontinued the ROCKnrol-1 Phase 3 study in newly diagnosed chronic GVHD patients based on a pre-specified interim futility analysis. Praluent Praluent (alirocumab) is a human monoclonal antibody (mAb) for self-administered injection every two weeks or once-monthly. It blocks the interaction of proprotein convertase subtilisin/kexin type 9 (PCSK9) with low-density lipoprotein (LDL) receptors, increasing the recycling of LDL receptors and reducing LDL cholesterol levels. Praluent is indicated as an adjunct to diet and maximally tolerated statin therapy in certain adult patients and in pediatric patients eight years of age and older with heterozygous familial hypercholesterolaemia (HeFH) with uncontrolled LDL cholesterol. Praluent has been approved in more than 60 countries worldwide, including the US (in 2015) and the European Union (in 2015). In 2018, the FDA approved a Praluent label update for patients currently requiring LDL apheresis therapy. In March 2019 in the EU and in April 2019 in the US, Praluent was approved for use in adults with established cardiovascular disease to reduce the risk of cardiovascular events. In November 2023, following a positive review by the EMA, the EC approved a Praluent label update for pediatric HeFh patients aged eight years and older. In December 2019, Praluent was approved in China, where it started to be commercialized in May 2020. Since April 2020, Regeneron has been responsible for commercialization of Praluent in the US, and Sanofi has been responsible for all other markets outside the US. For additional information on the commercialization of this medicine, see “Item 5. Operating and Financial Review and Prospects — A.1.7. Financial Presentation of Alliances — Alliance Arrangements with Regeneron Pharmaceuticals, Inc. (Regeneron).” Thymoglobulin Thymoglobulin (anti-thymocyte globulin) is a polyclonal anti-human thymocyte antibody preparation that acts as a broad immunosuppressive and immunomodulating agent. In the US, Thymoglobulin is indicated for the prophylaxis and/or treatment of acute rejection in patients receiving a kidney transplant, used in conjunction with concomitant immunosuppression. Outside the US, depending on the country, Thymoglobulin is indicated for the treatment and/or prevention of acute rejection in organ transplantation; immunosuppressive therapy in aplastic anemia; and the treatment and/or prevention of Graft-versus-Host Disease (GvHD) after allogeneic hematopoietic stem cell transplantation. Thymoglobulin is marketed in over 65 countries. Aprovel/Avapro/Karvea Aprovel, also known as Avapro or Karvea (irbesartan), is an angiotensin II receptor antagonist indicated for hypertension and for renal disease in patients with hypertension and type 2 diabetes. Sanofi also markets CoAprovel/Avalide/Karvezide, a combination of irbesartan and the diuretic hydrochlorothiazide. A combination with amlodipine (Aprovasc, Aprexevo, Aproxxamlo) has been launched in several countries. Irbesartan generics are available in most markets. Aprovel and CoAprovel are marketed in over 80 countries. In Japan, the medicine is licensed to Shionogi Co. Ltd and BMS KK, which sublicensed to Dainippon Pharma Co. Ltd. Multaq Multaq (dronedarone) is an oral anti-arrhythmic multichannel blocker indicated for preventing atrial fibrillation recurrences in patients with a history of paroxysmal or persistent atrial fibrillation. Multaq was approved in the US and in the EU in 2009. Multaq is available in approximately 35 countries. Soliqua – Suliqua Soliqua 100/33 or Suliqua is a once-daily fixed-ratio combination of insulin glargine 100 Units/mL, a long-acting analog of human insulin, and lixisenatide, a GLP-1 receptor agonist. The FDA approved Soliqua 100/33 in November 2016 for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 units daily) or lixisenatide; and in February 2019 for patients uncontrolled on oral antidiabetic medicines. In January 2017, Suliqua (the medicine’s brand name in Europe) was approved for use in combination with metformin with or without SGLT-2 inhibitors for the treatment of adults with type 2 diabetes to improve glycemic control, when this had not been provided either by metformin alone or by metformin combined with another oral glucose-lowering medicine or with basal insulin. The EU label was updated in 2024 to include “with or without SGLT2 inhibitors”. In Japan, Soliqua was approved in May 2020 for type 2 diabetes mellitus, where treatment with insulin is required. In China, Soliqua was approved in January 2023 for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycemic control as an adjunct to diet and exercise in addition to other oral antidiabetic drugs. Soliqua received NRDL status in China in December 2023. Soliqua is available in over 40 countries and approved in over 80 countries. Mozobil Mozobil (plerixafor injection) is a hematopoietic stem cell mobilizer. It is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma (NHL) and MM. Mozobil is marketed in over 65 countries. Generic Mozobil has been available in the US since the end of 2023, and in Europe since 2024. 32 SANOFI FORM 20-F 2025 PART I ITEM 4. Information on the Company Tzield/Teizeild Tzield (teplizumab) is a CD3-directed antibody (CD3 is a cell surface antigen present on T lymphocytes). It was approved by the FDA in November 2022 to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged eight years and older with Stage 2 type 1 diabetes. It was approved in Israel, the United Arab Emirates, Saudi Arabia, Kuwait, the UK and Canada during 2024 and 2025, and in January 2026 by the EC for the same indication under the brand name Teizeild. The medicine is currently marketed in the US, Israel, the United Arab Emirates, Saudi Arabia, Kuwait, Canada and the UK. It is currently in development for further indications, including treatment of patients already at Stage 3 (clinical onset) type 1 diabetes, as well as pediatric patients aged zero to seven at Stages 2 and 3 type 1 diabetes. The FDA accepted for priority review the sBLA for Tzield to expand the current age indication from eight years and above, to as young as one year old and above to delay the onset of stage 3 T1D in patients diagnosed with stage 2 T1D. The sBLA is supported by the positive interim one-year data from the ongoing PETITE-T1D phase 4 study, evaluating the safety and pharmacokinetics of Tzield in young children. Tzield is also under review in the US to delay the progression of stage 3 T1D in adults and children eight years of age and older recently diagnosed with stage 3 T1D. The FDA nominated Tzield for the Commissioner's National Priority Voucher pilot program based on its potential to address a large unmet medical need. Early Access Programs and Managed Access Programs are available in several European countries. Vaccines The Vaccines division of Sanofi is a world leader in the vaccine industry and a key supplier of life-saving vaccines all over the world and for publicly funded international stakeholders such as UNICEF, the Pan American Health Organization (PAHO) and the Global Alliance for Vaccines and Immunization (GAVI). The Vaccines portfolio includes the following products: Influenza vaccines Sanofi is a world leader in the production and marketing of influenza vaccines, offering several distinct influenza vaccines that are sold globally. As influenza strains can vary from one season to the next, the World Health Organization (WHO) selects the strains to be included in influenza vaccines for each season. For the 2024 season, the WHO recommended moving from quadrivalent influenza vaccines including two A strains and two B strains back to trivalent influenza vaccines including two A strains and one B strain, as it was considered that the B Yamagata strains were no longer circulating. Manufacturers have therefore progressively moved back from quadrivalent to trivalent influenza vaccines. In 2025, Sanofi switched to trivalent in most geographies. Fluzone High-Dose, designed specifically to provide greater protection against influenza for people aged 65 years and older, was approved by the FDA in November 2019 in its quadrivalent formulation. The high-dose vaccine was also approved in the EU in the second quarter of 2020, under the name Efluelda, indicated for adults aged 60 years and above. Both Fluzone High-Dose and Efluelda have been available since the 2020/21 influenza season. To date, this vaccine has been distributed to more than 25 countries worldwide. Fluzone High-Dose/Efluelda (trivalent formulation) includes two A strains and only one B strain. In October 2025, The Lancet published new data from the FLUNITY-HD study showing Fluzone High-Dose significantly reduced the risk of hospitalization in adults aged 65 years and older compared to standard-dose influenza vaccines. FLUNITY-HD is the largest influenza vaccine effectiveness study of individually randomized older adults, with nearly half a million participants across three influenza seasons. Flublok is a trivalent recombinant protein-based influenza vaccine licensed in the US, Hong Kong and Australia; this same recombinant protein-based influenza vaccine is also licensed under the brand name Supemtek in the United Kingdom. Flublok is indicated for individuals aged nine years and older in the US and for adults aged 18 and older in other countries. Fluzone trivalent is an inactivated trivalent influenza vaccine (TIV), produced in the US, containing two type A antigens and one type B antigen. Fluzone trivalent is available in five countries (including the US) for children aged over six months, adolescents and adults. Vaxigrip is a trivalent influenza vaccine, containing two antigens against type A influenza viruses and one antigen against type B influenza viruses. VaxigripTetra is the quadrivalent (QIV) version of Vaxigrip, including two antigens against A strains of influenza viruses and two antigens against B strains, and is produced in France. Vaxigrip Tetra was licensed in 2016 and has been approved in more than 90 countries. Following the new WHO recommendations, countries have switched back to Vaxigrip (trivalent) for the coming seasons. COVID Vaccine In 2025, Sanofi started to commercialize the recombinant adjuvanted COVID-19 vaccine Nuvaxovid, developed by Novavax. Sanofi is now the market authorization holder for this vaccine in the US, the EU and the United Kingdom, leading the commercialization of Nuvaxovid in the US for the 2025-26 season and expanding to other markets from the 2026-27 season and beyond. SANOFI FORM 20-F 2025 33 PART I ITEM 4. Information on the Company Poliomyelitis, pertussis and hemophilus influenzae type b (Hib) pediatric vaccines Sanofi is one of the key players in pediatric vaccines in both developed and emerging markets, with a broad portfolio of standalone and combination vaccines protecting against up to six diseases in a single injection. Due to the diversity of immunization schedules throughout the world, vaccines can be either quadrivalent, pentavalent, or hexavalent according to regional specificities. Tetraxim, a pediatric combination vaccine protecting against diphtheria, tetanus, pertussis and poliomyelitis (polio), was first marketed in 1998. To date, the vaccine has been launched in close to 100 countries (this vaccine is not marketed in the US). Pentaxim, a pediatric combination vaccine protecting against diphtheria, tetanus, pertussis, polio and Hemophilus influenzae type b (Hib), was first marketed in 1997. To date, the vaccine has been launched in more than 90 countries (this vaccine is not marketed in the US). In most European, Latin American, Asian and Middle Eastern markets, Pentaxim is being gradually replaced by Hexaxim. Hexaxim/Hexyon/Hexacima is a fully liquid, ready-to-use 6-in-1 (hexavalent) pediatric combination vaccine that provides protection against diphtheria, tetanus, pertussis, polio, Hib and hepatitis B. Hexaxim is the only combination vaccine including acellular pertussis (acP) and inactivated polio vaccines (IPV) currently prequalified by the WHO. First marketed in 2013, Hexaxim is now available in more than 100 countries outside the US. Pentacel, a pediatric combination vaccine protecting against diphtheria, tetanus, pertussis, polio and Hemophilus influenzae type b (Hib), was launched in the US in 2008. Quadracel is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis and polio, used in children aged four through six years as a fifth dose in the diphtheria, tetanus, pertussis vaccination (DTaP) series, and as a fourth or fifth dose in the IPV series. It was launched in the US in 2017. ACT-HIB is a standalone vaccine protecting against Hib, and is mainly distributed in the US in conjunction with pertussis combination vaccines that do not contain the Hib valence. Sanofi is a leading provider of polio vaccines and has been a partner of the Global Polio Eradication Initiative (GPEI) for over 30 years. Since Sanofi launched its first IPV, more than 1.5 billion doses have been distributed worldwide. Booster vaccines Adacel is the leading trivalent booster vaccine offering protection against diphtheria, tetanus and pertussis (Tdap). The vaccine can be used from four years of age following primary immunization and is the first Tdap vaccine indicated for use during pregnancy for protection against pertussis in newborns. It is available in approximately 70 countries including the US and other countries, mostly in Europe, Asia and Latin America. Recently, Adacel has been introduced in additional countries that are implementing new vaccination programs, particularly focusing on maternal immunization. Repevax/Adacel-Polio is a combination vaccine that provides protection against diphtheria, tetanus, pertussis and polio. It is the first Tdap-IPV vaccine indicated for use during pregnancy for protection against pertussis in newborns. It is currently marketed in approximately 25 countries outside the US, with a strong focus on European markets (such as France and Germany). Respiratory syncytial virus (RSV) protection In 2023, Sanofi launched Beyfortus (nirsevimab-alip), a long-acting monoclonal antibody designed to protect all infants against RSV. It is indicated for the protection of neonates and infants born during or entering their first RSV season, and for children up to 24 months who remain particularly vulnerable to severe RSV in their second RSV season. Beyfortus is licensed in numerous countries and has now been launched in more than 45 countries, including in North America, Europe, China and Japan. Real world data from countries such as the US, Spain and France have confirmed and even surpassed the outstanding efficacy data generated during the clinical development of this monoclonal antibody. Many more countries are expected to implement all-infant protection programs in the future. Sanofi and AstraZeneca plc (AstraZeneca) entered into an agreement in 2017 to develop and commercialize Beyfortus, under which AstraZeneca leads development and manufacturing activities and Sanofi leads commercialization activities and records revenues. Sanofi will continue to expand Beyfortus in new geographies across Europe, Asia and Latin America. 34 SANOFI FORM 20-F 2025 PART I ITEM 4. Information on the Company Meningitis and travel & endemic vaccines Menactra, the first quadrivalent conjugate vaccine against meningococcal meningitis (serogroups: A, C, Y, and W-135), one of the deadliest forms of meningitis, is indicated for people aged nine months through 55 years. Since launch, it has become a strong leader in the meningitis quadrivalent market. It is commercialized in a large number of countries (excluding Europe). Menactra was the first fully liquid (no reconstitution needed) meningitis quadrivalent conjugated vaccine, and more than 150 million doses of this vaccine have been distributed since launch. MenQuadfi is a novel fully-liquid meningococcal quadrivalent conjugated vaccine expected to have a broad age indication from infants (six weeks) to the elderly, with flexible dosing schedules. MenQuadfi has demonstrated consistent, long-lasting immune responses across serogroups A, C, W and Y, with demonstrated superiority for serogroup C in toddlers versus comparators (standard-of-care in multiple markets in Europe and internationally), while offering a favorable safety profile. Over time, MenQuadfi will fully replace Menactra. The product is currently approved and available across multiple markets worldwide, with over 23 million doses distributed since launch. In the US, regulatory approval extends to individuals aged six weeks and above, following the FDA label extension granted in May 2025. Sanofi provides a comprehensive portfolio of travel and endemic vaccines, including yellow fever, rabies, typhoid and hepatitis A vaccines. These vaccines are used by diverse populations, from populations in endemic regions to travelers and military personnel from non-endemic regions. Those vaccines are the foundation for important partnerships with governments and organizations such as UNICEF. Sanofi is currently investing in next-generation rabies and yellow fever vaccines to address evolving public health needs. Vaxelis Vaxelis is a hexavalent combination vaccine protecting against diphtheria, tetanus, pertussis, polio, Hib and hepatitis B. This vaccine (developed and distributed in partnership with Merck & Co., Inc.) was approved in 2016 by the EC and is distributed in various EU countries either by Sanofi or by MSD. Vaxelis was approved by the FDA in December 2018, becoming the first hexavalent vaccine to be approved in the US, and launched in that country in June 2021. Sales of Vaxelis in the US are recognized by the MSP Vaccine Company joint venture and credited equally to Merck & Co., Inc. and Sanofi as income from equity affiliates. Consequently, these sales are not reported separately in each joint venture partner’s net sales. Sanofi recognizes 50% of the joint venture's profits within the line item Share of profit/(loss) from investments accounted for using the equity method. SANOFI FORM 20-F 2025 35 PART I ITEM 4. Information on the Company B.3. Opella In October 2024, in line with its strategy of focusing on innovative medicines and vaccines, Sanofi announced that it had entered into exclusive negotiations for the sale of a controlling stake of around 50% in Opella to CD&R. Following those negotiations, Sanofi sold a 50% controlling stake in Opella to CD&R through a share purchase agreement and a separation agreement, which are described below. •Share Purchase Agreement In connection with the sale of a 50% controlling stake in Opella to CD&R (the Opella Transaction), on February 18, 2025, Sanofi and Opal Bidco SAS (Bidco) entered into a share purchase agreement (the SPA). Sanofi and Bidco made certain customary representations and warranties and agreed to certain customary covenants in connection with the SPA and the transaction closed on April 30, 2025 (the Closing). At Closing, Sanofi and CD&R (together with certain funds and affiliates) entered into a shareholders’ agreement (the Shareholders’ Agreement) relating to the associate Opal JV Co S.à R.L. (JV Co), the joint venture holding company that indirectly owns Opella following Closing. Sanofi retains a significant shareholding in Opella, through a 48.2% equity interest in JV Co. Bpifrance Participations acquired an approximately 1.8% equity interest in JV Co. at Closing and is represented on Opella’s Board. The Shareholders’ Agreement provides for a lock-up period of three years from Closing, during which Sanofi is only permitted to carry out certain types of direct or indirect transfers of its securities in JV Co, and thereafter any transfer by Sanofi is subject to a right of first offer in favor of CD&R, together with customary tag‑along and drag‑along rights. •Separation Agreement In connection with the separation of the Opella business, Sanofi entered into a Separation Agreement and certain other agreements with Opella on July 22, 2024, to effect the separation of the Opella business and provide a framework for their ongoing relationship. The Separation Agreement was amended on April 30, 2025. The Separation Agreement sets out the rights and obligations of the parties with respect to the separation, including the terms and conditions governing the transfer of assets to, and assumption of liabilities by, each of the Opella group and the Sanofi group. In particular, Sanofi retained Gold Bond Co LLC and its business, and provided for the allocation of retained assets and liabilities accordingly. The Sanofi group and the Opella group each agreed, subject to certain exceptions, to release and indemnify the other party and each of their respective past, present and future directors, officers, managers, agents and employees and each of the heirs, executors, administrators, successors and assigns of any of the foregoing from any and all claims against any of them that arise out of or relate to their respective businesses. The Sanofi group agreed to indemnify the Opella group in respect of all liabilities relating to Sanofi’s retained businesses (including environmental liabilities, whether arising before or after the Closing) and specified matters relating to Zantac branded products prior to Closing, including product liability claims arising from commercialization, and personal injury claims resulting from the manufacturing or handling of Zantac prior to Closing (see Note D.22.a. to our consolidated financial statements included at Item 18. of this annual report). B.4. Global research & development Redefining immunology as we know it, our immuno-science approach is the bedrock of Sanofi’s research and development (R&D). Combining our deep heritage and expertise in immunology, we are evaluating pathways of immunity and how they function independent of specific diseases or pathologies. Immuno-science is the connector of our R&D strategy, but it does not limit the depth and breadth of our pipeline. We continue to pursue all areas of urgent unmet need and promising scientific discovery, where we are uniquely positioned to achieve innovation for patients. This includes seeking out and engaging with external partners, ensuring we have access to the most innovative and cutting-edge scientific developments in our search of first- or best-in-class medicines. Our R&D pipeline is detailed in the section “— B.4.1. Biopharma pipeline” below. Discovering and developing new medicines is a costly, lengthy, and uncertain process and our continuous investments in R&D for future products and for the launches of newly registered medicines could result in increased costs without a proportionate increase in revenues. See “Item 3. Key Information — D. Risk Factors” for further information. 36 SANOFI FORM 20-F 2025 PART I ITEM 4. Information on the Company B.4.1. Biopharma pipeline For 2025, the main changes related to our medicines and vaccines pipeline were: Medicines/Vaccines Indication Change Reason elenestinib – D816V-mutated KIT inhibitor indolent/smoldering systemic mastocytosis Added Acquired from Blueprint Medicines SAR449028 – Wild-type KIT inhibitor chronic induced/spontaneous urticaria, allergic rhinoconjunctivitis Added Acquired from Blueprint Medicines SAR448501 – CD20 bispecific mAb inflammatory indication Added Acquired from Dren Bio SAR448851 – TREM2 agonist Alzheimer’s disease Added Acquired from Vigil Neuroscience SP0340 – subunit vaccine respiratory syncytial virus + human metapneumovirus (older adults) Added Acquired from Vicebio SP0341 – subunit vaccine respiratory syncytial virus + human metapneumovirus + parainfluenza virus type 3 (older adults) Added Acquired from Vicebio Redemplo – plozasiran - RNAi targeting APOC3 familial chylomicronemia syndrome Added Co-developed with Arrowhead Pharmaceuticals(a) Myqorzo – aficamten - Cardiac myosin inhibitor hypertrophic cardiomyopathy Added Co-developed with Corxel Pharmaceuticals(b) SAR402663 – sFLT01 AAV gene therapy wet age-related macular degeneration Added Entered confirmatory development SAR446268 – DMPK AAV gene therapy myotonic dystrophy type 1 Added Entered confirmatory development SAR446523 - GPRC5D mAb relapsed/refractory multiple myeloma Added Entered confirmatory development SAR446597 – Bb×C1s AAV gene therapy geographic atrophy in age-related macular degeneration Added Entered confirmatory development SAR448755 – STAT6 inhibitor inflammatory indication Added Entered confirmatory development SP0269 – mRNA vaccine chlamydia Added Entered confirmatory development eclitasertib - RIPK1 inhibitor ulcerative colitis Removed Development discontinued SAR443579 – Trifunctional anti-CD123 NK-cell engager acute myeloid leukemia Removed Development discontinued SAR444656 – IRAK4 degrader atopic dermatitis, hidradenitis suppurativa Removed Development discontinued SAR444881 – ILT2 mAb solid tumors Removed Development discontinued SAR445514 – Trifunctional anti-BCMA NK-cell engager inflammatory indication Removed Development discontinued SAR446159 – Synuclein × IGF1R mAb Parkinson’s disease Removed Development discontinued SAR447873 – SSTR targeting alpha-emitter therapy gastroenteropancreatic neuroendocrine tumors Removed Development discontinued SP0125 – Live attenuated vaccine respiratory syncytial virus (toddlers) Removed Development discontinued SP0237 – mRNA vaccine influenza Removed Development discontinued (a)Sanofi has an exclusive license to develop and commercialize plozasiran in China, where this medicine was approved in January 2026. (b)Sanofi has an exclusive license to develop and commercialize aficamten in China, where this medicine was approved in December 2025. The portfolio of products in clinical development (from Phase 1 to Phase 3) and in registration as of December 31, 2025 is described in “—E. R&D Appendix.” Phase 1 studies are the first studies performed in humans, who are mainly healthy volunteers, except for studies in oncology where Phase 1 studies are performed in patients. Their main objective is to assess the tolerability, the pharmacokinetic profile (the way the product is distributed and metabolized in the body and how it is eliminated) and where possible the pharmacodynamic profiles of the new drug (i.e. how the product may react on some receptors). Phase 2 studies are early controlled studies in patients under closely monitored conditions to show efficacy and short-term safety, and to determine the dose and regimen for Phase 3 studies. Phase 3 studies have the primary objective of demonstrating or confirming the therapeutic benefit and safety of the new drug in the intended indication and population. They are designed to provide an adequate basis for registration. B.4.1.1. Products in development Our R&D pipeline consists of innovative projects that are being developed to become first- or best-in-class medicines and vaccines. These projects are evaluated across four main disease areas (immunology, rare diseases, neurology, and oncology) plus vaccines, as detailed below. a) Immunology Sanofi delivered the first advanced biologic for atopic dermatitis with Regeneron, and this heritage in immunology is the foundation for our immunoscience approach. Pursuing our ambition to be leader in immunology, we are exploring ways to restore balance within the immune system, paving the way for treatments that address the root causes of a range of conditions, including those that may not be commonly associated with an autoimmune or inflammatory response. SANOFI FORM 20-F 2025 37 PART I ITEM 4. Information on the Company The main updates in respect of our immunology pipeline are detailed in the table below: Project Indication Development phase Pipeline updates in 2025 amlitelimab (OX40L mAb) atopic dermatitis Phase 3 Positive Phase 3 study readouts (COAST 1 in 2025, and in COAST 2 and SHORE in January 2026) asthma phase 2 Phase 2 study readouts: primary endpoint not met; improvements across key secondary endpoints (TIDE) hidradenitis suppurativa Removed from Phase 2 Negative outcome celiac disease Removed from Phase 2 Indication deprioritized alopecia areata Removed from Phase 2 Indication deprioritized systemic sclerosis Removed from Phase 2 Indication deprioritized lunsekimig (IL13×TSLP NANOBODY® VHH) chronic obstructive pulmonary disease Phase 3 New indication in pipeline; studies ongoing (PERSEPHONE and THESUS) asthma Phase 2 Study ongoing (AIRCULES) asthma, high-risk Phase 2 Study ongoing (AIRLYMPUS) chronic rhinosinusitis with nasal polyps Phase 2 Study ongoing atopic dermatitis Phase 2 New indication in pipeline; study ongoing brivekimig (TNFa×OX40L NANOBODY® VHH) hidradenitis suppurativa Phase 2 Phase 2a study readouts: primary endpoint met (HS-OBTAIN); Phase 2b study ongoing (BRIGHTEN) Crohn’s disease Phase 2 New indication in pipeline; study ongoing ulcerative colitis Phase 2 New indication in pipeline; study ongoing type 1 diabetes, stage 3 Phase 2 New indication; study ongoing (T1D OBTAIN) duvakitug (TL1A mAb) ulcerative colitis Phase 3 New phase; studies ongoing (SUNSCAPE-1 and SUNSCAPE-2).Phase 2b study readouts: primary endpoint met (RELIEVE UCCD); durable efficacy demonstrated in long-term extension study (RELIEVE UCCD LTE; February 2026) Crohn’s disease Phase 3 New phase; studies ongoing (STARCAPE-1 and STARCAPE-2).Phase 2b study readouts: primary endpoint met (RELIEVE UCCD); durable efficacy demonstrated in long-term extension study (RELIEVE UCCD LTE; February 2026) balinatunfib (oral TNFR1 signaling inhibitor) rheumatoid arthritis Removed from Phase 2 Phase 2 study readouts: primary endpoint not met; future development strategy under evaluation Crohn’s disease Phase 2 Study ongoing ulcerative colitis Phase 2 New indication in pipeline; study ongoing psoriasis Removed from Phase 2 Phase 2 study readouts: primary endpoint not met (SPECIFIC-PSO); removed from pipeline itepekimab (IL33 mAb) chronic obstructive pulmonary disease Phase 3 Phase 3 study readouts - primary endpoint met (AERIFY-1); not met (AERIFY-2) chronic rhinosinusitis with nasal polyps Phase 3 New indication in pipeline; studies ongoing (CEREN 1 and CEREN 2) bronchiectasis Removed from Phase 2 Indication deprioritized chronic rhinosinusitis without nasal polyps Phase 2 New indication in pipeline; study ongoing SAR449028(wild-type KIT inhibitor) chronic induced/spontaneous urticaria Phase 2 New project in pipeline; study ongoing allergic rhinoconjunctivitis Phase 2 New project in pipeline; study ongoing SAR444336(non-beta IL2 Synthorin) microscopic colitis Phase 2 New phase; study ongoing frexalimab (CD40L mAb) systemic lupus erythematosus Removed from Phase 2 Indication deprioritized type 1 diabetes Phase 2 Study ongoing rilzabrutinib (BTK inhibitor) asthma Phase 2 Phase 3 study to start in 2026 chronic spontaneous urticaria Phase 2 Phase 3 study to start in 2026 riliprubart (C1s mAb) antibody-mediated rejection Phase 2 Regulatory designation: US ODD SAR445399(IL1R3 mAb) hidradenitis suppurativa Phase 2 New phase; study ongoing (CLAROS) SAR446422(CD28×OX40 bispecific Ab) inflammatory indication Phase 1 Study ongoing SAR446959(MMP13×ADAMTS5×CAP NANOBODY® VHH) knee osteoarthritis Phase 1 Study ongoing SAR448501(CD20 bispecific mAb) inflammatory indication Phase 1 New project in pipeline; study ongoing SAR448755(STAT6 inhibitor) inflammatory indication Phase 1 New project in pipeline; study ongoing ODD: orphan drug designation; mAb: monoclonal antibody. 38 SANOFI FORM 20-F 2025 PART I ITEM 4. Information on the Company b) Rare Diseases We are advancing a robust pipeline in rare diseases, leveraging our deep understanding of the unique biological drivers that underpin these conditions with high unmet needs. Through our integrated R&D approach, we are also harnessing our immunoscience expertise to investigate novel molecules that could expand our pipeline into other rare diseases where significant unmet need remains. The main updates in respect of our rare diseases pipeline are detailed in the table below: Project Indication Development phase Pipeline updates in 2025 Qfitlia (fitusiran - RNAi targeting anti-thrombin) hemophilia A or B regulatory Approved in the US and in China;Phase 3 study ongoing (Atlas NEO) to support EU and Japan regulatory submissions Redemplo(plozasiran - RNAi targeting APOC3) familial chylomicronemia syndrome regulatory New project in pipeline; approved in China in January 2026 Wayrilz(rilzabrutinib - BTK inhibitor) immune thrombocytopenia regulatory Approved in the US and EU; under regulatory review in Japan warm autoimmune hemolytic anemia Phase 3 New indication in pipeline; study ongoing (LUMINA 3);Regulatory designations: US ODD; US breakthrough therapy and orphan drug in Japan (in February 2026) sickle cell disease Phase 3 New indication in pipeline; study ongoing (LIBRA); Regulatory designation: US ODD Graves’ disease Phase 2 New indication in pipeline; study ongoing IgG4-related disease Phase 3 New phase; study ongoing (RILIEF); Regulatory designations: US ODD, EU orphan designation; US FTD elenestinib(D816V-mutated KIT inhibitor) indolent/smoldering systemic mastocytosis Phase 3 New project in pipeline; study ongoing (HARBOR) venglustat (oral GCS inhibitor) Fabry disease Phase 3 Phase 3 study readouts (PERIDOT): primary endpoint not met; reduction in neuropathic and abdominal pain observed.Study evaluating effect on left cardiac ventricular mass index ongoing (CARAT). Gaucher disease type 3 Phase 3 Phase 3 study readouts (LEAP2MONO) in February 2026: primary endpoints met. Sanofi will pursue global regulatory filings. efdoralprin alfa(AAT fusion protein) alpha-1 antitrypsin deficiency emphysema Phase 2 Phase 2 study readouts: primary endpoint met (ElevAATe); Regulatory designations: US ODD, EU orphan designation frexalimab, rilzabrutinib, brivekimig focal segmental glomerulosclerosis/ minimal change disease Phase 2 New indication in pipeline; study ongoing (RESULT) SAR446268 (DMPK AAV gene therapy) myotonic dystrophy type 1 Phase 1 New project in pipeline; study ongoing (BrAAVe)Regulatory designation: US ODD ODD: orphan drug designation; FTD: fast-track designation; AAV: adeno-associated virus. c) Neurology Sanofi is developing new medicines built on patient insights and leading-edge science to help the millions of people living with neurological disorders. Using revolutionary technologies, Sanofi scientists are developing targeted, potentially disease-modifying therapies for people living with conditions such as MS. The goal is to design best-in-class medicines that slow or halt neurodegeneration, control neuroinflammation, and protect or even repair the nervous system. The main updates in respect of our neurology pipeline are detailed in the table below: Project Indication Development phase Pipeline updates in 2025 tolebrutinib(BTK inhibitor) secondary progressive multiple sclerosis (MS) regulatory Under regulatory review in the US and EU.Complete response letter issued by the FDA in December 2025; decision to go beyond the revised target action date of December 28, 2025. Regulatory designation: US priority review. primary progressive MS Removed from Phase 3 Study readouts - primary endpoint not met (PERSEUS) frexalimab (CD40L mAb) relapsing MS Phase 3 Study ongoing (FREXALT) non-relapsing secondary progressive MS Phase 3 Study ongoing (FREVIVA) riliprubart (C1s mAb) SOC-refractory CIDP Phase 3 Regulatory designation: JP ODD - Study ongoing IVIg-treated CIDP Phase 3 Regulatory designation: JP ODD - Study ongoing SAR402663(sFLT01 AAV gene therapy) wet age-related macular degeneration Phase 2 Regulatory designation: US FTD - Study ongoing SAR448851 (TREM2 agonist) Alzheimer’s disease Phase 1 New project in pipeline; study ongoing SAR446597 (Bb×C1s Ab AAV gene therapy) geographic atrophy in dry age-related macular degeneration Phase 1 New project in pipeline; study ongoingRegulatory designation: US FTD ODD: orphan drug designation; FTD: fast-track designation; mAb: monoclonal antibody; AAV: adeno-associated virus; CIDP: Chronic inflammatory demyelinating polyneuropathy SANOFI FORM 20-F 2025 39 PART I ITEM 4. Information on the Company d) Oncology Our oncology pipeline is focused on ways to boost the immune system to better detect and attack tumors, and on precision drugs designed to either destroy cancer cells or activate immune cells locally. The main updates in respect of our oncology pipeline are detailed in the table below: Project Indication Development phase Pipeline updates in 2025 SAR445877 (PD1×IL15 fusion protein) solid tumors Phase 2 New phase; study ongoing SAR445953 (CEACAM5-Topo1 ADC) colorectal cancer Phase 1 Study ongoing SAR446523(GPRC5D mAb) relapsed/refractory multiple myeloma Phase 1 New project in pipeline; study ongoing;Regulatory designation: US ODD ADC: antibody-drug conjugate; mAb: monoclonal antibody; ODD: orphan drug designation. e) Vaccines Our leadership in immunoscience drives transformative innovation across our vaccine portfolio. This expertise underpins our cutting-edge vaccine R&D, enabling us to help tackle global health challenges with innovative solutions. The main updates in respect of our vaccines pipeline are detailed in the table below: Project Indication Development phase Pipeline updates in 2025 SP0087 (vero cell vaccine) rabies Phase 3 Phase 3 study readouts: positive safety and immunogenicity results.Under regulatory review in the EU. SP0202 (21-valent conjugate vaccine) pneumococcal disease (children) Phase 3 Study ongoing SP0218(vero cell vaccine) yellow fever Phase 3 New phase; study ongoing SP0230(5-valent ACWY+B vaccine) meningitis Phase 2 Study ongoing SP0256 (mRNA vaccine) RSV+hMPV (older adults) Phase 2 Phase 2b study readouts (RSV mRNA vaccine alone): high efficacy RSV mRNA vaccine alone on several endpoints.Phase 1/2 study readouts (RSV+hMPV mRNA vaccine): very competitive anti-hMPV antibody levels evidenced. SP0268 (mRNA vaccine) acne Phase 2 New phase; study ongoing SP0289 (mRNA vaccine) flu H5 pandemic Phase 2 Phase 1/2 study: good safety profile and strong immunogenicity results;New phase; phase 2 study ongoing SP0335 (inactivated adjuvanted vaccine) flu H5 pandemic Phase 2 Sanofi received funding from the BARDA for early-stage clinical work on this vaccine candidate including Novavax’s Matrix-M adjuvant. SP0269 (mRNA vaccine) chlamydia Phase 1 New project in pipeline; Phase 1/2 study ongoing;Regulatory designation: US FTD SP0287 (Fluzone HD + Nuvaxovid) flu+COVID-19 Phase 1 Phase 1/2 study: preliminary positive safety and immunogenicity results SP0287 (Flublok + Nuvaxovid) flu+COVID-19 Phase 1 Phase 1/2 study: preliminary positive safety and immunogenicity results SP0291 (mRNA vaccine) RSV+hMPV+PIV3 (older adults) Phase 1 Study ongoing SP0340 (subunit vaccine) RSV+hMPV (older adults) Phase 1 New project in pipeline; study ongoing SP0341 (subunit vaccine) RSV+hMPV+PIV3 (older adults) Phase 1 New project in pipeline; study ongoing FTD: fast-track designation; BARDA: Biomedical Advanced Research and Development Authority; RSV: respiratory syncytial virus; hMPV: human metapneumovirus; PIV3: parainfluenza virus type 3. 40 SANOFI FORM 20-F 2025 PART I ITEM 4. Information on the Company B.4.1.2. Line extensions The main updates in R&D activities supporting line extensions for our marketed products are summarized below. For more information on marketed products, see also “ — B.2. Biopharma segment.” Marketed product Line extension indication Development phase Pipeline updates in 2025 Dupixent (dupilumab – IL4R mAb) chronic obstructive pulmonary disease Regulatory Approved in Japan chronic spontaneous urticaria Regulatory Approved in the US and the EU;Under regulatory review in the US, the EU and Japan (children) bullous pemphigoid Regulatory Approved in the US after priority review;Under regulatory review in the EU, Japan and China allergic fungal rhinosinusitis Regulatory Phase 3 study readouts: primary endpoint met (LIBERTY-AFRS-AI)Under regulatory priority review in the US chronic pruritus of unknown origin Phase 3 Phase 3 study ongoing (LIBERTY-CPUO-CHIC) lichen simplex chronicus Phase 3 Phase 3 studies ongoing (STYLE 1 and STYLE 2) eosinophilic gastritis Removed from Phase 3 Indication deprioritized ulcerative colitis Removed from Phase 2 Indication deprioritized Tzield/Teizeild(a) (teplizumab – CD3 mAb) type 1 diabetes, stage 2, delay of onset stage 3 Regulatory Approved in China and in the EU.Regulatory designation: US priority review for young children type 1 diabetes, stage 3, delay of progression Regulatory Under regulatory priority review in the US.Not recommended for EU approval by the CHMP; Sanofi has decided not to progress with the application at this time. Next steps are under evaluation. Rezurock (belumosudil – ROCK2 inhibitor) Chronic graft versus host disease, third line Regulatory CHMP positive recommendation obtained in January 2026, after Sanofi requested a re-examination of the prior negative opinion adopted in October 2025 chronic lung allograft dysfunction Phase 3 Phase 3 study ongoing (ROCKaspire) chronic graft versus host disease, first line Removed from Phase 3 Phase 3 study discontinued based on pre-specified futility interim analysis (ROCKnrol-1) Nexviazyme (avalglucosidase alfa –enzyme replacement therapy) infantile-onset Pompe disease Phase 3 Study ongoing (Baby-COMET) Cerezyme (imiglucerase – enzyme replacement therapy) Gaucher disease type 3 Regulatory Approved in the US (in January 2026) Sarclisa (isatuximab – CD38 mAb) NDMM, TI Regulatory Approved in the EU, Japan and China NDMM, TE Regulatory Approved in the EU;Phase 3 studies ongoing (GMMG HD7 and IsKia) to support additional regulatory submissions R/R MM, subcutaneous formulation Regulatory Phase 3 study readouts: primary endpoints met;Under regulatory review in the US, the EU, Japan and China smoldering multiple myeloma Phase 3 Phase 3 study ongoing (ITHACA) R/R MM in combination Phase 2 Study ongoing Fluzone HD (multivalent inactivated vaccine) flu (50+ years) Phase 3 Phase 3 study readouts: positive safety and immunogenicity results at interim analysis MenQuadfi (4–valent ACWY conjugate vaccine) meningitis (six weeks+) Regulatory Approved in the US (a) Teplizumab is known as Tzield, except in the EU where it is known as Teizeild. mAb: monoclonal antibody; CHMP: Committee for Medicinal Products for Human Use; NDMM: newly diagnosed multiple myeloma; TE: transplant-eligible; TI: transplant-ineligible. B.4.2. R&D Expenditures Expenditures on research and development amounted to €7,842 million in 2025 (€7,394 million in 2024). Research and development expenditures represented approximately 18.0% of our net sales in 2025, compared with 18.0% in 2024. R&D spend, excluding the 2024 one-off Sobi reimbursement following the registration of ALTUVIIIO in Europe, increased 6.3% year over year, driven by strategic prioritization of key therapeutic growth areas (in particular immunology, rare diseases, neurology and vaccines) and wind-down costs for the discontinued E. coli sepsis vaccine candidate, as well as new acquisitions and in‑licensing agreements completed in 2025. Oncology spend was selectively reduced to support portfolio rebalancing to immunology. SANOFI FORM 20-F 2025 41 PART I ITEM 4. Information on the Company B.5. Markets A breakdown of revenues by segment and by geographical region for 2025, 2024, and 2023 can be found at Notes D.34. and D.35. to our consolidated financial statements, included at Item 18. of this annual report. The following market shares and ranking information are based on consolidated national pharmaceutical sales data (excluding vaccines), in constant euros, on a September 2025 Moving Annual Total (MAT) basis. The data are mainly from IQVIA MIDAS local sales audits supplemented by various other country-specific sources including Knobloch (Mexico), GERS (France) and HMR (Portugal). B.5.1. Marketing and distribution We have business operations in approximately 60 countries and our products are available in more than 160 countries. A breakdown of our aggregate net sales by geographical region is presented in “Item 5. Operating and Financial Review and Prospects — Results of Operations — Year Ended December 31, 2025 Compared with Year Ended December 31, 2024.” Sanofi is the ninth largest pharmaceutical company globally by sales. Our main markets in terms of net sales are respectively: •US: we rank twelfth with a market share of 2.2%; •Europe: we are the sixth largest pharmaceutical company in France where our market share is 4.0%, and we rank sixth in Germany with a 3.0% market share; and •other countries: we are ranked twelfth in Japan with a market share of 2.4%, and seventh in China with a market share of 1.6%. Although specific distribution patterns vary by country, we sell prescription drugs primarily to wholesale drug distributors, independent and chain retail drug outlets, hospitals, clinics, managed-care organizations and government institutions. Some products in Rare Diseases and Oncology may also be sold directly to physicians. Our drugs are ordinarily dispensed to patients by pharmacies upon presentation of a doctor’s prescription. Our vaccines are sold and distributed through multiple channels including physicians, pharmacies, hospitals, private companies and distributors in the private sector, and governmental entities and non-governmental organizations in the public and international donor markets. We use a range of channels from in-person to digital to disseminate information about and promote our products among healthcare professionals, ensuring that the channels not only cover our latest therapeutic advances but also our established prescription products, which satisfy patient needs in some therapy areas. In some countries, products are also marketed directly to patients by way of television, radio, newspapers and magazines, and digital channels (such as the internet), in accordance with local regulations. National education and prevention campaigns can be used to improve patients’ knowledge of their conditions. We regularly exhibit at major medical congresses. Our sales representatives, who work closely with healthcare professionals, use their expertise to promote and provide scientific information on our drugs, and to inform healthcare professionals when necessary about alternative access to our drugs for their patients. They represent our values on a day-to-day basis and are required to adhere to a code of conduct and to internal policies on which they receive training. Sanofi markets most of its products through its own own sales forces. Nevertheless, Sanofi has entered into and continues to form alliances to promote/market or co-promote/co-market certain products in specific geographical areas. Our major alliances are detailed at “Item 5. Operating and Financial Review and Prospects — A.1.7. Financial Presentation of Alliances.” See also “Item 3. Key Information — D. Risk Factors — We rely on third parties for the discovery, manufacture and marketing of some of our products.” B.5.2. Competition The pharmaceutical industry continues to experience significant changes in its competitive environment. There are four primary types of competition in the prescription pharmaceutical market: •competition among pharmaceutical companies to research and develop new patented products or address unmet medical needs; •competition among different patented pharmaceutical products for the same therapeutic indication, including competition for market access, as is currently being observed in particular in the US (but also in other markets around the world). The number of drugs excluded from leading pharmacy benefit managers’ formularies has increased dramatically over the past 11 years in the US commercial health insurance market, with a total of 1,357 unique medications having faced exclusion for at least one year from one PBM, mostly in crowded therapeutic areas. For 2025, the three largest pharmacy benefit managers (PBMs) – Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group) – have again each excluded 600 or more drugs from their standard formularies. Formulary exclusions and utilization management are tools used by payers to manage prescription drug costs and leverage their negotiating power with manufacturers; •competition among original and generic products or original biological products and biosimilars, at the end of regulatory exclusivity or patent protection; and •competition among generic or biosimilar products. Generics manufacturers who have received all necessary regulatory approvals for a product may decide to launch a generic version before the patent expiry date, even in cases where the owner of the original product has already commenced patent infringement litigation against the generics manufacturer. Such launches are said to be “at risk” for the owner and the promoter of the generic product because it may be required to pay damages to the owner of the original product in the context of patent infringement litigation; however, such launches may also significantly impair the profitability of the pharmaceutical company whose product is challenged. 42 SANOFI FORM 20-F 2025 PART I ITEM 4. Information on the Company Drug manufacturers also face intra-product competition through parallel trade, where legally permitted. This refers to the practice whereby parallel traders or importers purchase drugs in one country and sell them in another country without the authorization of the original drug manufacturer. This usually occurs in markets where price differences exist due to factors like varying regulations, taxes or exchange rates. The parallel trader or importer will repackage or resize the original product with leaflets in the local language and sell it through an alternative channel at a higher price. This situation is of particular relevance in the EU single market, where such practices have been encouraged by the current regulatory framework. Some of the risks arising from parallel trade include quality and safety concerns, breach of intellectual property rights and supply chain disruptions (see “Item 3. Key Information — D. Risk Factors”). The industry is also facing a proliferation of falsified and substandard medicines, a problem particularly widespread in low- and middle-income countries. The WHO estimates that 10% of medicines in these regions are falsified, affecting all therapeutic areas including vaccines. Worldwide, falsified products are an issue, due in part to an exponential rise in internet connectivity of those engaged in the manufacture, distribution and supply of substandard and falsified medical products. In Vaccines, there are two primary types of competition: •competition for innovation in the development of new vaccines, including breakthrough technologies (such as mRNA vaccines introduced against COVID-19) or address unmet medical needs; and •competition among different patented (or non-patented) vaccine products marketed for the same therapeutic indication. In contrast, generics and biosimilars do not directly affect vaccines, which rely on proprietary viral or bacterial strains. Competition from parallel importers remains limited due to the specific requirements for vaccines, such as the cold chain and the need for administration by healthcare professionals. B.5.3. Regulatory framework The pharmaceutical and health-related biotechnology sectors are highly regulated. Sanofi’s business is subject to varying degrees of governmental regulation in the countries in which operations are conducted. National and supranational health authorities, such as the FDA in the US, the EMA and the EC in the EU, and the PMDA and the MHLW in Japan, administer a vast array of legal and regulatory requirements that dictate pre-approval testing (including testing in human subjects) and quality standards to maximize the safety and efficacy of a new medical product. These authorities also regulate product labeling, manufacturing, importation/exportation, safety reporting, marketing and supply chains, as well as mandatory post-approval requirements and commitments. Prior to commercializing a pharmaceutical or biological product, approval by relevant regulatory authorities is required, based upon the authority’s review of submitted pre-approval testing results and pursuant to processes that may vary across jurisdictions and product type. The submission of an application to a regulatory authority does not guarantee that a license or approval to market will be granted. Furthermore, each regulatory authority may impose its own requirements during product development or during the application review. It may refuse to grant approval or require additional data before granting approval, even in circumstances in which the same product has already been approved in other countries. Regulatory authorities also have the authority to request product recalls and product withdrawals, to impose penalties for violations of regulations, and ultimately the ability to revoke product licensure or approval. Product review and approval can vary from six months or less to several years from the date of application submission, depending upon the country and regulatory jurisdiction. Factors such as the quality of data and evidence, the review procedures, the nature of the product, the condition to be treated, and any potential shifts in regulatory priorities, play a major role in the length of time a product is under review, and whether or not the product is ultimately licensed or approved. For a description of material risks relating to the regulatory environment in which we operate, refer to “Item 3.D. Risk Factors — Risks relating to legal and regulatory matters.” B.5.4. Pricing & reimbursement We are operating in a new era of drug pricing and market access, driven by sweeping policy changes and shifting market dynamics in 2026. We are facing heightened uncertainty in a changing world triggered by the US Presidential Administration's most favored nation (MFN) policy and global price harmonization. See “Item 5. Operating and financial Review and Prospects — A.1.1 2025 Overview — 2025 Business Developments.” In this new era, governments and other payers will demand more value for money and superior evidence (e.g. comparative efficacy studies, real-world patient data, budget modelling), raising the bar for market entry in many countries. Looking ahead to 2026 and beyond, we anticipate that new policies in the US and EU will have a transformative impact on our portfolio, on long-term pharma growth and the whole innovation ecosystem. United States Overview of the US health insurance system Commercial insurance is offered widely as part of employee benefit packages and is the main source of employee access to subsidized healthcare. Some individuals purchase private health plans directly or through marketplaces established under the SANOFI FORM 20-F 2025 43 PART I ITEM 4. Information on the Company Affordable Care Act, while publicly subsidized programs provide coverage for retirees, the indigent, the disabled, uninsured children, and active or retired military personnel. Double coverage can occur. Commercial insurance includes: •Managed Care Organizations (MCOs), which combine the functions of health insurance, delivery of care, and administration. MCOs use specific provider networks and specific services and products. There are four primary types of managed care plans: Health Maintenance Organizations (HMOs), Preferred Provider Organizations (PPOs), Exclusive Provider Organizations (EPOs), and Point of Service (POS) plans; and •PBMs, which serve as intermediaries between insurance companies, pharmacies and manufacturers to negotiate rebates and discounts on formulary placement for commercial health plans, self-insured employer plans, Medicare Part D plans, and federal and state government employee plans. Government insurance includes: •Medicare, which provides health insurance for retirees and for people with permanent disabilities. The basic Medicare scheme (Part A) provides hospital insurance only, and the vast majority of retirees purchase additional cover through some or all of three other plans named Part B, Part C and Part D. Part D enables Medicare beneficiaries to obtain outpatient drug coverage. Almost two-thirds of all Medicare beneficiaries have enrolled in Part D plans; •Medicaid, which provides health insurance for low-income families, certain qualified pregnant women and children, individuals receiving supplemental security income, and other eligible persons determined on a state-by-state basis; and •TRICARE, which provides health insurance for uniformed service members, retirees, and their families including comprehensive healthcare, prescription and dental coverage. The US remains the world’s largest pharmaceutical market, projected to reach $1.2 trillion by 2029. It continues to serve as the primary innovation hub with strong access to new therapies. However, 2026 marks a pivotal shift with two major federal policies reshaping the drug pricing landscape. The Inflation Reduction Act (IRA) introduces negotiated prices for high-cost Medicare drugs, while the MFN voluntary agreements, signed with the US Administration, provide tariff exemptions in return for substantial discounts on select medicines, including those for Medicaid, Medicare, the direct-to-consumer market and future launches. In May 2025, the US administration issued the MFN pricing executive order, which aims to align US drug prices with the lowest prices paid in a basket of comparable OECD nations. On December 19, 2025, we signed a voluntary MFN agreement with the US government. Under this agreement, we committed to align Medicaid prices on certain wholly owned medicines with other high income countries; cut prices by 61% for select diabetes, cardiovascular, neurological, and cancer drugs; offer around 70% discounts via the TrumpRx DTC platform (e.g. Plavix from $756 to $16); and expand the $35 monthly insulin cap to all US patients effective January 1, 2026. The new pricing agreement is expected to accelerate the commoditization of our insulins and mature US portfolio. The Centers for Medicare & Medicaid Services (CMS) have also introduced two new mandatory five-year drug pricing models: the Global Benchmark for Efficient Drug Pricing (GLOBE) Model for Medicare Part B launching on October 1, 2026, and the Guarding US Medicare Against Rising Drug Costs (GUARD) Model for Medicare Part D launching on January 1, 2027. Both models will apply an MFN international reference pricing approach to selected Medicare covered medicines, aiming to align US prices more closely with international benchmarks. If implemented, these mandatory drug pricing models could have a material adverse effect on our business. The IRA, signed into law in August 2022, will continue to exert unprecedented price pressure that will compress margins and shorten product lifecycles (eight years for small molecules and 12 years for biologics). Some of the key provisions of the law relate to Medicare price negotiations, inflation penalties on price increases, and Medicare Part D redesign, all phased in between 2022 and 2026. The most impactful change relates to Medicare drug price negotiations, starting with ten Part D drugs in 2026, expanding to 15 drugs in 2027–2028, and 20 drugs annually from 2029 onward, including Part B. Negotiated rebates average approximatively 62%, creating significant revenue pressure. The first negotiated prices took effect on January 1, 2026, with the negotiated prices of the next 15 drugs expected to be announced by February 2026. The IRA is projected to cut federal drug spending by $290 billion over the next decade, according to estimates from the Congressional Budget Office (CBO), signaling significant headwinds for industry revenue growth and innovation. In addition, in commercial channels, we continue to face intensifying pricing pressure and gross-to-net (GTN) erosion from payers and pharmacy benefit managers (PBMs), resulting in tighter utilization management and a dramatic increase of formulary exclusions, tighter utilization management, higher rebate demands, and accumulator/maximizer programs. Moreover, rapidly shifting federal vaccine policies drive uncertainty, primarily triggered by recent changes to the Advisory on Immunization Practices (ACIP) membership and scepticism toward existing immunization frameworks. These policy changes may have long-term market implications and affect future pandemic preparedness. 44 SANOFI FORM 20-F 2025 PART I ITEM 4. Information on the Company Europe In Europe, the pharmaceutical environment remains highly fragmented and challenging, shifting from traditional national budget constraints to a complex framework shaped by the US MFN policy and sweeping EU‑level legislative reforms. The combined impact of MFN pricing pressure and a potential new debt crisis in key European economies has shifted political attention back to the pharmaceutical sector, renewing recognition of its role as a strategic engine of economic growth at both national and European levels. The US MFN policy is creating significant upward pricing pressures across Europe. Driven by efforts to rebalance global drug prices, MFN pressures are pushing major EU countries to maintain higher prices for innovative medicines in order to avoid price spillovers in the US and other markets. As a result, companies are exercising tighter control over EU launches and volumes, prioritizing price integrity over speed of access. At the same time, many European health systems that rely on clawbacks, paybacks, and mandatory rebates to contain pharmaceutical spending are now revising their national policies to adapt to the evolving pricing landscape.These mechanisms create high barriers to market entry for new products, with nearly half of innovative medicines remaining unavailable to patients in 2024, according to the EFPIA's Patients W.A.I.T Indicator Survey. Recent reforms signal attempts to balance fiscal cost-containment with competitiveness and innovation incentives, as exemplified by the UK-US landmark deal signed on December 1, 2025, capping future UK clawback at around 15%, raising NICE's cost-effectiveness threshold to £25k-£35k per QALY, and committing a budget increase for innovative drugs of 0.6% of GDP by 2035. However, significant delays persist across Europe. France, for example, often requires 12 to 24 months for reimbursement decisions, while other markets experience similar lengthy timelines. Germany stands out as the only major EU market providing immediate access. Moreover, new EU-level regulations are reshaping the European pharmaceutical landscape. The EU Pharma Package, aimed at modernizing the regulatory framework, preserves the eight-year baseline data protection, while introducing a more flexible, conditional exclusivity model, including extensions for products that address unmet medical needs or meet certain innovation criteria. Despite improvements to the initial Commission proposal, concerns remain about the expanding Bolar exemption enabling earlier generic entry, and new access and supply obligations for manufacturers expected to apply from January 2027, increasing regulatory and compliance burdens. The new legislation is anticipated to be adopted in the first quarter of 2026, with implementation foreseen by mid-2028. In parallel, the EU Health Technology Assessment (HTA) Regulation, in force since January 2025, mandates Joint Clinical Assessments (JCAs) for oncology and advanced therapy medicinal products (ATMPs), with orphan drugs following in 2028 and all products, including vaccines, by 2030. The new mandatory JCAs tighten evidence requirements and significantly increase the workload for industry. In 2025, 13 initial JCAs were completed, comprising 10 oncology therapies and 3 ATMPs. The first wave of JCA reports, expected in 2026, will bring clarity on how the new process operates in practice and how joint assessments will be used by national HTA bodies across Member States. China China is accelerating healthcare reforms under Healthy China 2030, focusing on managing the growing burden of chronic diseases such as cancer, diabetes, and cardiovascular conditions while balancing access to innovation with cost containment. Regulatory timelines have improved significantly, as illustrated by Dupixent gaining approval within six months through an accelerated review process. China is emerging as a global biopharma innovation hub, accounting for 30% of global clinical trial starts in 2024 according to IQVA's Global Trends in R&D 2025 report. In 2023, 30 medicines discovered in China were approved, representing 37% of all new drugs. The biotech sector is growing at a rate of 70% annually, and one in four innovative drug discoveries now originates in China. Western pharmaceutical companies increasingly license early-stage assets from Chinese innovators, signaling a shift in global innovation geography. Overall, the landscape is becoming more predictable with rapid innovation and evolving funding models, albeit with steep price cuts and intensifying local competition. Pricing pressure remains intense, driven by NRDL negotiations and Volume-Based Procurement (VBP) tenders, where the lowest price prevails. Access to innovative therapies has expanded rapidly, supported by annual NRDL updates. Effective January 1, 2026, the new NRDL list added 114 new drugs, of which 50 are Class I innovative drugs (i.e. China as the first global launch country), and removed 29 drugs, signaling stricter evidence standards. VBP is expected to expand to multi-source biologics in 2026, building on VBP insulin pilots. Since its launch in 2018, VBP has become a key policy tool to control drug costs, with a cumulative 490 drugs included through 11 rounds, and average price cuts ranging from 48% to 70%. At the same time, funding models are evolving through a dual-track system that separates basic coverage under NRDL from premium-priced therapies supported by commercial health insurance (CHI). The new Commercial Health Insurance Innovative Drug List (CHIIDL), also effective January 2026, enables access to 19 high-cost, innovative drugs that address rare and unmet needs, with lower price cuts (15%–50%) compared to NRDL’s average 60%. The new commercial list is expected to grow the role of CHI in China, projected to increase from less than 8% today to nearly 30% coverage by 2035, creating substantial opportunities for innovative medicines. Pricing and reimbursement pressures are being felt in other regions and countries around the globe. To overcome these challenges, we are developing tailored market access strategies early in the drug development process, engaging in dialogue with payers and multiple stakeholders throughout the lifecycle, based on a thorough understanding of evolving market dynamics. SANOFI FORM 20-F 2025 45 PART I ITEM 4. Information on the Company B.6. Patents, intellectual property and other rights Intellectual property rights are essential to our business because they protect our innovations and investments in research and development, manufacturing and marketing of our products. Intellectual property rights include patents, trademarks, copyrights, know‑how, trade secrets and regulatory-based protection. Patent protection We own a broad portfolio of patents, patent applications and patent licenses worldwide. These patents are of various types and may cover: active ingredients; pharmaceutical formulations; product manufacturing processes; intermediate chemical compounds; therapeutic indications/methods of use; technology platforms; delivery systems; digital applications; and enabling technologies, such as assays. Patent protection is considered, in the aggregate, to be of material importance to the marketing and sales of our products. Patent protection for individual products typically extends for 20 years from the patent filing date in countries where we seek patent protection. A substantial part of the 20-year life span of a patent on a new molecule (small molecule or biologic) has generally already passed by the time the related product obtains marketing authorization. As a result, the effective period of patent protection for an approved product’s active ingredient is significantly shorter than 20 years. In some cases, the period of effective protection may be extended by procedures established to compensate regulatory delay in Europe (via Supplementary Protection Certificate or SPC), in the US (via Patent Term Extension or PTE), in Japan (PTE), and in China (PTE). The protection a patent provides to the related product depends upon the type of patent and its scope of coverage, and may also vary from country to country. We monitor our competitors and vigorously seek to challenge patent infringers when such infringement would negatively impact our business objectives. See note D.22.b. to the consolidated financial statements included at Item 18. of this annual report. The expiration or loss of a patent covering a new molecule, typically referred to as a compound patent, may result in significant competition from generic or biosimilar products and can result in a dramatic reduction in sales of the original branded product (see “Item 3. Key Information — D. Risk Factors”). In some cases, it is possible to continue to benefit from a commercial advantage through product manufacturing trade secrets or other types of patents. Certain categories of products, such as traditional vaccines and insulin, were historically relatively less reliant on patent protection and may in many cases have no patent coverage. It is increasingly frequent for novel vaccines also to be patent protected. Regulatory exclusivity In some markets, including the EU and the US, many of our pharmaceutical products may also benefit from multi-year regulatory exclusivity periods, during which a generic or biosimilar competitor may not rely on our clinical study and safety data in its drug application. This exclusivity operates independently of patent protection and may protect the product from generic or biosimilar competition even if there is no patent covering the product. United States •The FDA may not grant final marketing authorization to a generic competitor for a New Chemical Entity (NCE) until the expiration of the regulatory exclusivity period (five years) that commences upon the first marketing authorization of the reference listed drug. •Significant new uses of existing NCEs, including new indications, may qualify for an additional three years of regulatory exclusivity if certain conditions are met. •For biological drugs, the FDA may not approve a biosimilar application until 12 years after the date on which the reference product was first licensed. •Pediatric extensions are available under certain conditions of the Hatch-Waxman Act by providing data on pediatric studies. Under such cases the FDA allows for an extension of regulatory exclusivity and patent life by six months, to the extent these protections have not already expired (the so-called “pediatric exclusivity”). •Orphan drug exclusivity may be under certain circumstances to drugs intended to treat rare diseases or conditions. European Union •Regulatory exclusivity is available in two forms: data exclusivity and marketing exclusivity. •Generic or biosimilar drug applications will not be accepted for review until eight years after the first marketing authorization (data exclusivity). This eight-year period is followed by a two-year period during which generics or biosimilars cannot be marketed (marketing exclusivity). •The marketing exclusivity period can be extended to three years if, during the first eight-year period, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which are deemed to provide a significant clinical benefit over existing therapies. This is known as the “8+2+1” rule. •Pediatric extensions - A regulation on pediatric medicines provides for pediatric research obligations with potential associated rewards including extension of supplementary patent protection and six-month regulatory exclusivity for pediatric marketing authorization (for off-patent medicinal products). •Orphan drug exclusivities also exist in the EU. 46 SANOFI FORM 20-F 2025 PART I ITEM 4. Information on the Company Japan •The regulatory exclusivity period varies, but is generally four to six years for drugs for a specific use, and for medicinal products with new indications or with new dosages; eight years for drugs containing a new chemical entity; ten years for orphan drugs, and for new drugs requiring pharmaco-epidemiological study; six to eight years for innovative drugs (“SAKIGAKE” products), and for orphan drugs with a new ethical combination or new mode of administration; and six years for other medicinal products, such as new prescription combination drugs or drugs requiring a new mode of administration. •There is no pediatric research extension of patent protection for patented medicinal products. However, regulatory exclusivity may be extended from eight to ten years. Emerging markets One of the main limitations on our operations in emerging market countries is the lack of effective intellectual property protection or enforcement for our products, which frequently do not provide non-patent exclusivity for innovative products. While the situation has gradually improved, the lack of protection for intellectual property rights or the lack of robust enforcement poses difficulties in certain countries. Additionally, in recent years a number of countries have waived or threatened to waive intellectual property protection for specific products, for example through compulsory licensing of generics. See “Item 3. Key Information — D. Risk Factors — Risks Relating to Sanofi’s Structure and Strategy — The globalization of our business exposes us to increased risks in specific areas.” Product and patent overview We summarize in the table below the intellectual property coverage (in some cases through licenses) of our most significant marketed products in terms of sales, in our major markets. In the discussion of patents below, we focus on active ingredient patents (compound patents) and, in the case of NCEs, on any later filed patents listed as applicable in the FDA’s list of Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) or in its foreign equivalents. For biologics, the Orange Book listing does not apply. The table provides a list of expiration dates, which include six-month pediatric extensions when applicable, and when indicated, extensions due to Patent Term Adjustment (PTA) or other regulatory delays. Where patent terms have expired we indicate such information and mention whether generics or biosimilars are on the market. References below to patent protection in Europe indicate the existence of relevant patents in most major markets in the EU. Specific situations may vary by country. We additionally set out any regulatory exclusivity from which these products continue to benefit in the EU, US or Japan. Regulatory exclusivities presented below incorporate any pediatric extensions obtained. While EU regulatory exclusivity is intended to be applied throughout the EU, in some cases Member States have taken positions prejudicial to our exclusivity rights. For regulatory exclusivity in the US, only NCE or BLA are provided. In the EU, the regulatory exclusivity based on the first MA is given. United States European Union Japan Dupixent Compound: March 2031 with PTE* Compound: September 2032 with SPC* (March 2033 with pediatric extension of SPC* in process of being granted across EU countries) Compound: May 2034 with PTE* Later filed patents: coverage ranging through April 2045 (pending) Later filed patents: coverage ranging through December 2043 (pending) Later filed patents: coverage ranging through August 2043 (pending) Regulatory exclusivity: March 2029 Regulatory exclusivity: September 2028 Regulatory exclusivity: January 2026 Toujeo Compound: expired Compound: expired Compound: expired Later filed patents: coverage ranging through May 2031 Later filed patents: coverage ranging through May 2031 Later filed patents: coverage ranging through July 2033 with PTE* Lantus Compound: expired Compound: expired Compound: expired Generics/biosimilars on the market Generics/biosimilars on the market Generics/biosimilars on the market Lovenox Compound: expired Compound: expired Compound: expired Generics on the market Biosimilars on the market Plavix Compound: expired Compound: expired Compound: expired Generics on the market Generics on the market Generics on the market Fabrazyme Patent: expired Patent: expired Patent: expired Generics/biosimilars on the market Myozyme Compound: expired Compound: expired Compound: expired Alprolix Use: December 2027 with PTE* Compound: May 2029 with SPC* Compound: February 2026 with PTE* Later filed patents: coverage ranging through April 2039 (pending) Later filed patents: coverage ranging through December 2037 (pending) Later filed patents: coverage ranging through December 2037 (pending) Regulatory exclusivity: March 2026 Regulatory exclusivity: May 2028 Cerezyme Patent: expired Patent: expired Patent: expired SANOFI FORM 20-F 2025 47 PART I ITEM 4. Information on the Company United States European Union Japan Praluent Compound: December 2029 Compound: December 2029 (SPC* in process of being granted across EU countries) Compound: December 2034 with PTE* Later filed patent: coverage ranging through December 2036 Later filed patent: coverage ranging through July 2035 Later filed patent: coverage ranging through July 2035 Regulatory exclusivity: July 2027 NEW LAUNCHES Beyfortus Compound: January 2035 (PTE* pending) Compound: January 2035 (SPC* in process of being granted across EU countries) Compound: January 2035 (PTE* pending) Later filed patent: coverage ranging through September 2042 (pending) Later filed patent: coverage ranging through September 2042 (pending) Later filed patent: coverage ranging through September 2042 (pending) Regulatory exclusivity: July 2035 Regulatory exclusivity: November 2032 Regulatory exclusivity: March 2032 Nexviazyme/Nexviadyme Compound: March 2030 with PTA* (PTE* pending) Compound: January 2028 (SPC* in process of being granted across EU countries) Compound: December 2032 with PTE* Later filed patents: coverage ranging through May 2032 Later filed patents: coverage ranging through May 2032 Later filed patents: coverage ranging through December 2029 Regulatory exclusivity: pending Regulatory exclusivity: September 2031 Sarclisa Compound: October 2032 with PTA* and PTE* Compound: October 2032 with SPC* Compound: October 2032 with PTE* Later filed patents: coverage ranging through November 2041 (pending) Later filed patents: coverage ranging through November 2041 (pending) Later filed patents: coverage ranging through November 2041 (pending) Regulatory exclusivity: March 2032 Regulatory exclusivity: May 2030 Regulatory exclusivity: June 2028 ALTUVIIIO Compound: February 2037 with PTA* (PTE* pending) Compound: January 2035 (SPC* in process of being granted across EU countries) Compound: March 2037 with PTE* Later filed patents: coverage ranging through March 2043 (pending) Later filed patents: coverage ranging through March 2043 (pending) Later filed patents: coverage ranging through March 2043 (pending) Regulatory exclusivity: February 2035 Regulatory exclusivity: June 2034 Regulatory exclusivity: September 2031 Rezurock Compound : June 2034 with PTA* and PTE* N/A Compound : March 2031 with PTE* Later filed patents : coverage ranging through July 2042 Later filed patents : August 2037 and October 2038 (PTEs* granted) Regulatory exclusivity: July 2028 Regulatory exclusivity: March 2034 Cablivi Compound: February 2032 with PTA* and PTE* Compound: May 2031 with SPC* Compound: May 2031 with PTE* Later filed patents: coverage ranging through 2039 Later filed patents: coverage ranging through 2039 (pending) Later filed patents: coverage ranging through 2039 (pending) Regulatory exclusivity: Feb. 2031 Regulatory exclusivity: Sep. 2030 Regulatory exclusivity: Sep. 2032 Xenpozyme Use: March 2036 with PTA* and PTE* Use: August 2030 (SPC* in process of being granted across EU countries) Use: August 2030 (PTE* pending) Later filed patents: coverage ranging through 2043 (pending) Later filed patents: coverage ranging through 2043 (pending) Later filed patents: coverage ranging through 2043 (pending) Regulatory exclusivity: August 2034 Regulatory exclusivity: June 2032 Regulatory exclusivity: March 2030 Tzield / Teizeld Compound : Expired Compound : Expired N/A Later filed patents : coverage ranging through May 2043 (pending) Later filed patents : coverage ranging through May 2043 (pending) Regulatory exclusivity: November 2034 Regulatory Exclusivity: January 2036 Ayvakit Compound: Oct 2034 Compound: Sep 2035 with SPC Later filed patents: coverage ranging through Feb 2045 (pending PCT) Later filed patents: coverage ranging through Feb 2045 (pending PCT) N/A Regulatory exclusivity: Jun 2025 Regulatory exclusivity: Sep 2030 Qfitlia Compound: March 2033 (PTE* pending) N/A N/A Later filed patents: coverage ranging through March 2046 (pending) Regulatory exclusivity: March 2030 Wayrilz Compound: Sept 2033 (PTE* pending) Compound: Sept 2033 N/A Later filed patents: coverage ranging through 2044 (pending) Later filed patents: coverage ranging through 2044 (pending) Regulatory exclusivity NCE: Aug 2030 Regulatory exclusivity NCE: Dec 2035 * PTE: Patent Term Extension; – SPC: Supplementary Protection Certificate; – PTA: Patent Term Adjustment; - PCT Patent Cooperation Treaty; - NCE : New Chemical Entity 48 SANOFI FORM 20-F 2025 PART I ITEM 4. Information on the Company Third-party patents and challenges to intellectual property Patents held or licensed by Sanofi do not in all cases provide effective protection against a competitor’s generic or biosimilar version of our products. For example, notwithstanding the presence of unexpired patents, competitors launched generic versions of Allegra in the US (prior to the product being switched to over-the-counter status) and Multaq in the EU. We caution the reader that there can be no assurance that we will prevail when we assert a patent in litigation and that there may be instances in which Sanofi determines that it does not have a sufficient basis to assert one or more of the patents mentioned in this report, for example in cases where a competitor proposes a formulation not appearing to fall within the claims of our formulation patent; a salt or crystalline form not claimed by our composition of matter patent; or an indication not covered by our method of use patent. See “Item 3. Key Information — D. Risk Factors — Risks Relating to Legal and Regulatory Matters — We rely on our patents and other proprietary rights to provide exclusive rights to market certain of our medicines and vaccines. If such patents and other rights were limited, invalidated, or circumvented, our financial results could be adversely affected” As disclosed in Item 8. of this annual report, we are involved in significant litigation concerning the patent protection of a number of our products. In addition to directly challenging our intellectual property rights, in some circumstances a competitor may be able to market a generic version of one of our products. In the US, competitor generic companies can challenge patents by filing Abbreviated New Drug Applications (ANDAs) to receive authority to market a generic version of our approved products, by demonstrating that the purportedly generic version has the same properties (safety and other technical data) as the original approved product. Our products and patents are also subject to challenge by under section 505(b)(2) of the US Federal Food, Drug, and Cosmetic Act, which allows for approval for a wide range of products, especially for those products that represent only a limited change from an existing approved drug. Similarly, entities wishing to market a generic biologic can utilize an abbreviated approval pathway established in the PHS Act. This §351(k) pathway enables an applicant to rely on a reference product sponsor’s data when seeking approval of a biological product shown to be biosimilar (highly similar with no clinically meaningful differences) or interchangeable with an FDA-licensed reference BLA product. See also “— B.5.3. Regulatory Framework” above. In the EU, a generic drug manufacturer may only reference the data of the regulatory file for the original approved product after data exclusivity has expired. Generic products may be approved for marketing following the expiration of marketing exclusivity without regard to the patent holder’s rights. Nevertheless, in most of these jurisdictions once the competing product is launched, and in some jurisdictions even prior to launch (once launch is imminent), the patent holder may seek an injunction against such marketing if it believes its patents are infringed. See Item 8. of this annual report. We seek to defend our patent rights vigorously in these cases. Success or failure in the assertion of a given patent against a competing product is not necessarily predictive of the future success or failure in the assertion of the same patent. See “Item 3. Key Information — D. Risk Factors — Risks Relating to Legal and Regulatory Matters — We rely on our patents and other proprietary rights to provide exclusive rights to market certain of our medicines and vaccines. If such patents and other rights were limited, invalidated, or circumvented, our financial results could be adversely affected.” B.7. Production and raw materials We have opted to manufacture the majority of our products in-house. There are three principal stages in our production process: the manufacture of active ingredients, the transformation of those ingredients into drug products or vaccines, and the final packaging. Our general policy is to produce our key active ingredients and main drug products at our own plants in order to reduce our dependence on external suppliers. We also rely on third parties for the manufacture and supply of specific active ingredients, drug products and medical devices. Active ingredients are manufactured using raw materials sourced from suppliers who have been subject to rigorous selection and approval procedures, in accordance with international standards and our own internal directives. We have outsourced some of our production under supply contracts associated with acquisitions of products or businesses or with Sanofi plant divestitures, or to establish a local presence to capitalize on growth in emerging markets. Our pharmaceutical subcontractors follow our general quality and logistics policies, as well as meeting other criteria. We also obtain active ingredients from third parties under collaboration agreements. This applies in particular to the monoclonal antibodies developed with Regeneron. Our production sites are divided into three categories: •global sites, which serve all markets: located mainly in Europe, these facilities are dedicated to the manufacture of our active ingredients, injectable products, and a number of our main solid-form products; •regional sites, which serve markets at regional level, giving us a strong industrial presence in emerging markets; and •local sites, which serve their domestic market only. Vaccines produces vaccines at various sites, with the main locations situated in France, the US, Canada, India, Mexico and China. The pharmaceutical site at Le Trait (France) also contributes to Vaccines’ industrial operations by making its sterile filling facilities available for vaccine manufacturing. All of our production facilities are good manufacturing practice (GMP) compliant, in line with international regulations. SANOFI FORM 20-F 2025 49 PART I ITEM 4. Information on the Company Our main sites are approved by the FDA: •the Specialty Care facilities in the US (Framingham MA and Northborough MA), France (Lyon Gerland, Vitry-sur-Seine, Le Trait), Germany (Frankfurt), Ireland (Waterford) and Belgium (Geel); •the General Medicines facilities in Germany (Frankfurt), France (Aramon, Sisteron, Ploermel, Ambarès and Tours), Italy (Anagni and Scoppito), Singapore (Jurong) and the US (Ridgefield NJ); •the Vaccines facilities in France (Marcy l’Étoile, Le Trait, Val-de-Reuil and Neuville-sur-Saône), the US (Swiftwater PA) and Canada (Toronto); and •during 2025, the Opella facilities approved by FDA in France (Compiègne) and the US (Chattanooga TN) were divested as part of the Opella divestment. More details are given above at section "— B.3. Opella.” Wherever possible, we seek to have multiple plants approved for the production of key active ingredients and our strategic finished products (this is the case with Lovenox and Dupixent, for example). More details about our manufacturing sites are given below at section “— D. Property, Plant and Equipment.” B.8. Insurance and risk coverage We are protected by five main insurance programs, relying not only on the traditional corporate insurance and reinsurance market but also on our direct insurance company, Carraig Insurance DAC (Carraig). These five key programs cover Property & Business Interruption; General & Product Liability; Stock & Transit; loss and liability arising from cyber and digital risks; and Directors & Officers Liability. Carraig participates in our coverage for various lines of insurance including Property, Stock & Transit, Cyber/Digital, and General & Product Liability. Carraig is run under the supervision of the Irish and European regulatory authorities, is wholly owned by Sanofi, and has sufficient resources to meet those portions of our risks that it has agreed to cover. Carraig sets premiums for our entities at market rates. Claims are assessed using the traditional models applied by insurance and reinsurance companies, and Sanofi's reserves are regularly verified and confirmed by independent actuaries. Our Property & Business Interruption program covers all our entities worldwide, in all territories where it is possible to use a centralized program operated by Carraig. By sharing risk between our entities, this approach enables us to set deductibles and cover appropriate to the needs of local entities before the market attachment point. It also incorporates a prevention program, including a comprehensive site visit schedule covering our production, storage, research and distribution facilities and standardized repair and maintenance procedures across all sites. The Stock & Transit program protects all goods owned by Sanofi while they are in transit nationally or internationally, whatever the means of transport, and all our inventories wherever they are located. Sharing risk between our entities through Carraig means that we can set deductibles at appropriate levels, for instance differentiating between goods that require temperature controlled distribution and those that do not. We have developed a prevention program with assistance from experts, implementing best practices in this area at our distribution sites. Our Cyber/Digital insurance program protects our operations against loss originating from various sources, and against liability in respect of data security. Centralized through Carraig, the program enables us to set deductibles and cover appropriate to the needs of local entities before the market attachment point. Our General & Product Liability program was renewed in 2025 for all our subsidiaries worldwide in all territories where it was possible to do so. For several years, insurers have been reducing product liability coverage because of the difficulty of transferring risk for some products that have been subject to numerous claims. The principal risk exposure for our pharmaceutical products is covered with low deductibles at country level, with a greater proportion of risk being retained. The level of risk self-insured by Sanofi (including via Carraig) before the market attachment point enables us to retain control over the management and prevention of risk. Our negotiations with third-party insurers and reinsurers are tailored to our specific risks. In particular, they allow for differential treatment of products in the development phase, for discrepancies in risk exposure between European countries and the US and for specific issues arising in certain jurisdictions. Coverage is adjusted every year to take account of the relative weight of new product liability risks such as those arising out of biotechnologies and new technology platforms. Our coverage for risks that are not specific to the pharma-biotech industry (general liability) is designed to address the potential impacts of our operations. For all the insurance programs handled by Carraig, outstanding claims are covered by provisions for the estimated cost of settling all claims incurred but not paid at the balance sheet date, whether reported or not, together with all related claims handling expenses. Where there is sufficient data history from Sanofi or from the market for claims made and settled, management – with assistance from independent actuaries – prepares an actuarial estimate of our exposure to unreported claims for the risks covered. The actuaries perform an actuarial valuation of the company’s Incurred But Not Reported (IBNR) and Allocated Loss Adjustment Expense (ALAE) liabilities at year end. Two ultimate loss projections (based upon reported losses and paid losses, respectively) are computed each year using various actuarial methods including the Bornhuetter-Ferguson method; those projections form the basis for the provisions set. The Directors & Officers Liability program protects all legal entities under our control, and their directors and officers. Carraig is not involved in this program. 50 SANOFI FORM 20-F 2025 PART I ITEM 4. Information on the Company We also operate other insurance programs, but these are of much lesser importance than those described above. All our insurance programs are backed by highly-rated insurers and reinsurers and are intended to be designed in such a way that we can integrate most newly acquired businesses without interruption of cover. Our insurance coverage has been designed to reflect our risk profile and the capacity available in the insurance market. By centralizing our major programs, we are able to provide what we believe to be excellent, cost effective protection. B.9. Health, Safety, and Environment Our manufacturing and research operations are subject to increasingly stringent health, safety and environmental (HSE) laws and regulations. These laws and regulations are complex and rapidly changing, and Sanofi invests the necessary sums in order to comply with them. This investment, which aims to respect HSE matters, varies from year to year. Applicable environmental laws and regulations may require us to reduce the effects of chemical substance discharge at our various sites. The sites in question may belong to Sanofi, and may be currently operational, or may have been owned or operational in the past. In this regard, Sanofi may be held liable for the costs of removal or remediation of hazardous substances on, under or in the sites concerned, or on sites where waste from activities has been stored, without regard to whether the owner or operator knew of or under certain circumstances caused the presence of the contaminants, or at the time site operations occurred the discharge of those substances was authorized. As is the case for a number of companies in the pharmaceutical, chemical and intense agrochemical industries, soil and groundwater contamination has occurred at some of our sites in the past, and may still occur or be discovered at others. In Sanofi’s case, such sites are mainly located in the US, Germany and France. As part of a program of environmental surveys conducted over the last few years, detailed assessments of the risk of soil and groundwater contamination have been carried out at current and former Sanofi sites. In cooperation with national and local authorities, Sanofi regularly assesses the rehabilitation work required and carries out such work when appropriate. Remediation works have just been completed at Beaucaire in France. Long-term rehabilitation work is in progress or planned in Mount Pleasant, Portland in the US; Frankfurt in Germany; Valernes, Septèmes and Limay in France; and on a number of sites divested to third parties and covered by contractual environmental guarantees granted by Sanofi. We may also have potential liability for investigation and clean-up at several other sites. We have established provisions for the sites already identified and to cover contractual guarantees for environmental liabilities for sites that have been divested. In France specifically, we have provided the financial guarantees to the authorities as required under French regulations for environmental protection in connection with the operation of activities on French sites. Potential environmental contingencies arising from certain business divestitures are described in Note D.22.d. to the consolidated financial statements. In 2025, Sanofi spent €31 million on rehabilitating sites previously contaminated by soil or groundwater pollution. Due to changes in environmental regulations governing site remediation, our provisions for remediation obligations may not be adequate due to the multiple factors involved, such as the complexity of operational or previously operational sites, the nature of claims received, the remediation techniques involved, the planned timetable for rehabilitation, and the outcome of discussions with national regulatory authorities or other potentially responsible parties, as in the case of multiparty sites. Given the long industrial history of some of our sites and the legacy obligations arising from the past involvement of Aventis in the chemical and agrochemical industries, it is impossible to quantify the future impact of these laws and regulations with precision. See “Item 3.D. Risk Factors — Environmental and safety risks of our industrial activities.” We have established, in accordance with our current knowledge and projections, provisions for cases already identified and to cover contractual guarantees for environmental liabilities relating to sites that have been divested. In accordance with Sanofi standards, a comprehensive review is carried out once a year on the legacy of environmental pollution. In light of data collected during this review, we adjusted our provisions to €493 million as of December 31, 2025 versus €474 million as of December 31, 2024. The terms of certain business divestitures, and the environmental obligations and retained environmental liabilities relating thereto, are described in Note D.22. to our consolidated financial statements. To our knowledge, Sanofi did not incur any liability in 2025 for non-compliance with current HSE laws and regulations that could be expected to significantly jeopardize its activities, financial situation or operating income. We also believe that we are in substantial compliance with current HSE laws and regulations and that all the environmental permits required to operate our facilities have been obtained. Regular HSE audits are carried out by Sanofi in order to assess compliance with standards (which implies compliance with regulations) and to initiate corrective measures (26 entities audited, grouped into 21 internal audits performed in 2025). Moreover, in 2025, 180 specific visits were performed jointly with experts representing our insurers. Sanofi has implemented a worldwide master policy on HSE to promote the health and well-being of the employees and contractors working on its sites and respect for the environment. We consider this master policy to be an integral part of our commitment to social responsibility. In order to implement this master policy, Sanofi key requirements have been drawn up in the key fields of HSE management, HSE leadership, safety in the workplace, process safety, occupational hygiene, health in the workplace and protection of the environment. However, despite these efforts, Sanofi may be unsuccessful in the implementation of its policy to reduce and mitigate the harmful effects of its activities on the health and safety of its employees, customers or the general public and on the environment more generally. See “Item 3. Key information — D. Risk Factors” for further information. SANOFI FORM 20-F 2025 51 PART I ITEM 4. Information on the Company Health From the development of compounds to the commercial launch of new drugs, Sanofi research scientists continuously assess the effect of products on human health. This expertise is made available to employees through two committees responsible for chemical and biological risk assessment. Sanofi’s COVALIS (Comité des Valeurs Limites Internes Sanofi) Committee is responsible for the hazard determination and classification of all API and synthesis intermediates handled at Sanofi facilities. This covers all active ingredients handled in production at company sites or in processes sub-contracted for manufacture. Any important issues involving raw materials or other substances that lack established occupational exposure limits may also be reviewed. The COVALIS Committee determines the occupational exposure limits required within Sanofi. Our TRIBIO Committee is responsible for classifying all biological agents according to their degree of pathogenicity and virulence, and applies rules for their containment and the preventive measures to be respected throughout Sanofi. See “Item 3. Key Information — D. Risk Factors — Environmental and safety risks of our industrial activities — Risks from manufacturing activities and the handling of hazardous materials could adversely affect our results of operations and reputation.” Appropriate occupational hygiene practices and programs are defined and implemented in each site. These practices consist essentially of containment measures for collective and individual protection against chemical and biological exposure in all workplaces where chemical substances or biological agents are handled. All personnel are monitored with an appropriate medical surveillance program, based on the results of professional risk evaluations linked to their duties. In addition, dedicated resources have been created to implement the European Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and the European Regulation on Classification, Labeling and Packaging of chemicals (CLP). To fully comply with REACH, Sanofi has registered the relevant hazardous chemical substances with the European Chemicals Agency (ECHA). While these measures focus on managing chemical and biological risks, Sanofi's commitment to employee well-being extends beyond safety protocols. Through the All Well program, Sanofi offers comprehensive health and wellbeing support to all its employees. This program supports mental and physical health, providing various global and local resources to promote healthy nutrition, physical activity, vaccination, and health checkups, as well as a Global Employee Assistance Program, ensuring a holistic approach to employee health and safety. Safety Sanofi has rigorous policies to identify and evaluate safety risks and to develop preventive safety measures, and methods for checking their efficacy. Additionally, Sanofi invests in training that is designed to instill in all employees a sense of concern for safety, regardless of their duties. These policies are implemented on a worldwide scale to ensure the safety of all employees and to protect their health. Each project, whether in research, development or manufacturing, is subject to evaluation procedures, incorporating the chemical substance and process data communicated by the COVALIS and TRIBIO Committees described above. The preventive measures are designed primarily to reduce the number and seriousness of work accidents and to minimize exposures involving permanent and temporary Sanofi employees as well as our sub-contractors. The French chemical manufacturing sites in Aramon and Sisteron are upper-tier Seveso sites according to the Seveso III regulations (from the name of the European directive that deals with potentially dangerous establishments where dangerous substances may be present in quantities exceeding certain thresholds to prevent major accidents and limit their consequences). In accordance with French law on technological risk prevention, the French sites are also subject to heightened security inspections due to the toxic or flammable materials stored on the sites and used in the operating processes. In Europe, our Frankfurt site is listed as a lower-tier Seveso site. Risk assessments of processes and installations are drawn up according to standards and internal guidelines incorporating the best state of the art benchmarks for the industry. These assessments are used to fulfill regulatory requirements and are regularly updated. Particular attention is paid to any risk-generating changes such as process or installation changes, as well as changes in production scale and transfers between industrial or research units. We are using specialized process safety-testing laboratories that are fully integrated into our chemical development activities, apply methods to obtain the physico-chemical parameters of manufactured chemical substances (intermediate chemical compounds) and apply models to measure the effect of potentially leachable substances in the event of a major accident. In these laboratories the parameters for qualifying hazardous reactions are also determined, in order to define scale-up process conditions while transferring from development stage to industrial scale. We use these data to enhance the relevance of our risk assessments. We believe that the safety management systems implemented at each site, the hazard studies carried out and the risk management methods implemented, as well as our third-party property insurance policies covering any third-party physical damage, are consistent with legal requirements and the best practices in the industry, although no guarantee can be given that they will prevent accidents of various kinds. We have also designed a new Global Safety Culture program – “Leading Safety” – to help protect the health and safety of our employees, contractors and communities. It is based on five positive performance drivers: strengthen safety leadership; focus on key risks; increase managerial skills; improve safety barriers and the effectiveness of controls; and increase reports of unsafe acts & hazardous conditions. 52 SANOFI FORM 20-F 2025 PART I ITEM 4. Information on the Company Environment Beyond healthcare, we have taken steps to address the environmental impacts of our products and activities and to help strengthen our resilience in the face of environmental changes. We have identified a number of environmental challenges relevant to our businesses: greenhouse gas emissions and climate disruption; eco-design; water; pharmaceuticals in the environment; waste; and biodiversity. We have been implementing environmental initiatives since 2010. More recently, we established the Planet Care program, which seeks to address environmental impacts across the value chain. We have also taken measures to seek to reduce our greenhouse gas emissions and to promote circularity and the use of sustainable resources. We have set both medium-term and long-term targets. See “Cautionary statement regarding forward-looking statements” and “Item 3.D. Risk Factors.” C. Organizational Structure C.1. Significant Subsidiaries Sanofi is the holding company of a consolidated group consisting of almost 200 companies. The table below sets forth our significant subsidiaries as of December 31, 2025. For a fuller list of the principal companies in our consolidated group, see Note F. to our consolidated financial statements included at Item 18. of this annual report. Significant subsidiary Date ofincorporation Country ofincorporation Principal activity Financial and voting interest Aventis, Inc. July 1, 1968 United States Pharmaceuticals 100% Bioverativ Therapeutics, Inc. June 17, 1997 United States Pharmaceuticals 100% Genzyme Corporation November 21, 1991 United States Pharmaceuticals 100% Hoechst GmbH July 8, 1974 Germany Pharmaceuticals 100% Sanofi-Aventis Deutschland GmbH June 30, 1997 Germany Pharmaceuticals 100% Sanofi-Aventis Participations SAS February 25, 2002 France Pharmaceuticals 100% Sanofi-Aventis Singapore Pte Ltd May 14, 1997 Singapore Pharmaceuticals 100% Sanofi Biotechnology December 23, 2013 France Pharmaceuticals 100% Sanofi Foreign Participations B.V. April 29, 1998 Netherlands Pharmaceuticals 100% Sanofi Pasteur February 8, 1989 France Pharmaceuticals 100% Sanofi Pasteur, Inc. January 18, 1977 United States Pharmaceuticals 100% We have transformed Sanofi through numerous acquisitions and divestments, in particular the deconsolidation of EUROAPI in May 2022 and the divestment of Opella in April 2025 (for a description of the main such events over the past three years, refer to “A. History and Development of the Company” above). In certain countries, we carry on some of our business operations through joint ventures with local partners. In addition, we have entered into worldwide collaboration agreements, in particular with Regeneron on Dupixent and Kevzara and with AztraZeneca on Beyfortus. For further information, refer to Note C. “Principal Alliances” to our consolidated financial statements, included at Item 18. of this annual report. C.2. Internal organization of activities Sanofi and its subsidiaries collectively form a group organized around a Biopharma operating segment (Immunology, Rare diseases, Neurology, Oncology, Other Medicines, and Vaccines). See “Item 5. Operating and Financial Review and Prospects — A.1.1. 2025 Overview.” Sanofi's R&D function is structured around two main areas: •Medicines: under the responsibility of Sanofi and Genzyme Corporation; and •Vaccines: under the responsibility of Sanofi Pasteur and Sanofi Pasteur, Inc. The R&D organization operates in an integrated manner on a global scale, with centralized definition of strategic priorities and global coordination of research programs. These main entities subcontract research and development activities to subsidiaries with the appropriate technical and scientific capabilities. Sanofi and its main subsidiaries grant licenses for patents, manufacturing know-how, and trademarks to their French and international subsidiaries. These licensed subsidiaries handle the manufacturing, marketing, and distribution of Sanofi medicines and vaccines, either directly to end customers or through local distribution subsidiaries. Our industrial property rights, patents and trademarks are mainly held by the following legal owner: Sanofi, Sanofi Biotechnology, and Sanofi R&D Vaccins (formerly Sanofi Pasteur) (France); Sanofi-Aventis Deutschland GmbH (Germany); Ablynx (Belgium); Kymab Ltd (UK;, Genzyme Corporation, Bioverativ, Inc., Kadmon Corporation LLC, Amunix Pharmaceuticals, Inc., Principia Biopharma, Inc., Sanofi Vaccines US Inc (formerly Sanofi Pasteur, Inc.), sanofi-aventis US LLC, Translate Bio , Synthorx, Inc., and Provention Bio, Inc. (US); and Sanofi Vaccines Canada Ltd (formerly Sanofi Pasteur Limited) (Canada). SANOFI FORM 20-F 2025 53 PART I ITEM 4. Information on the Company For a description of our principal items of property, plant and equipment, see “— D. Property, Plant and Equipment” below. Our property, plant and equipment is held mainly by the following companies: •in France: Sanofi Pasteur SA, Sanofi Winthrop Industrie and Sanofi-Aventis Recherche & Développement; •in the US: Sanofi Pasteur, Inc., Genzyme Therapeutics Products LP, Genzyme Corporation and Translate Bio; •in Germany: Sanofi-Aventis Deutschland GmbH; •in Canada: Sanofi Pasteur Limited; •in Belgium: Genzyme Flanders BVBA; and •in Ireland: Genzyme Ireland Limited. C.3. Financing and financial relationships between group companies The Sanofi parent company raises the bulk of the Company’s external financing and uses the funds raised to meet, directly or indirectly, the financing needs of its subsidiaries. The parent company operates a cash pooling arrangement under which any surplus cash held by subsidiaries is managed centrally. There is also a centralized foreign exchange risk management system in place, whereby the parent company contracts hedges to meet the needs of its principal subsidiaries. Consequently, at December 31, 2025, the Sanofi parent company held 93% of our external financing and 83% of our surplus cash. In addition, the Sanofi parent company, plus the wholly-owned Sanofi subsidiaries Sanofi European Treasury Center SA (SETC) and/or Genzyme Ireland Limited, provide financing and certain financial services to Sanofi subsidiaries. D. Property, Plant and Equipment D.1. Overview Our headquarters are located in Paris, France. We operate our business through office premises and research, production and logistics facilities in approximately 60 countries around the world. Our office premises house all of our support functions, plus operational representatives from our subsidiaries and the Company. A breakdown of our sites by use and by ownership status (owned versus leasehold) is provided below. This breakdown is based on surface area. All surface area figures are unaudited. Breakdown of sites by use Breakdown of sites by ownership status Industrial 59% Leasehold 26% Research 16% Owned 74% Offices 16% Logistics 5% Other 4% D.2. Description of our sites Sanofi industrial sites As part of the process of transforming Sanofi and creating Global Business Units, we are continuing to adapt the organization of the Manufacturing & Supply department in support of our new business model. The Manufacturing & Supply department focuses on customer needs and service quality; the sharing of “Sanofi Manufacturing System” good manufacturing practices; and the development of a common culture committed to quality. The organizational structure of Manufacturing & Supply is aligned on our corporate structure and our three Global Business Units: Specialty Care, General Medicines and Vaccines.. The Manufacturing & Supply department is also responsible for Sanofi Global HSE and Global Supply Chain. At the end of 2025, we were carrying out industrial production at 37 sites in 19 countries: •8 sites for our Specialty Care operations; •19 sites for our General Medicines operations; and •9 sites for the industrial operations of Vaccines. During 2025, 13 sites were divested as part of the Opella divestment (see “Item 5. Operating and Financial Review and Prospects — A.1.1. 2025 Overview”). The quantity of units sold in 2025, including in-house and outsourced production, was 2 billion units. 54 SANOFI FORM 20-F 2025 PART I ITEM 4. Information on the Company We believe that our production facilities are in compliance with all material regulatory requirements, are properly maintained and are generally suitable for future needs. We regularly inspect and evaluate those facilities with regard to environmental, health, safety and security matters, quality compliance and capacity utilization. For more information about our property, plant and equipment, see Note D.3. to our consolidated financial statements, included at Item 18. of this annual report, and section “B.7. Production and Raw Materials” above. Our main production sites by volume are: •Le Trait (France), Frankfurt (Germany), Waterford (Ireland), Geel (Belgium) and Framingham (US) for Specialty Care; •Aramon, Sisteron and Ambarès (France), Frankfurt (Germany), Csanyikvölgy (Hungary), Lüleburgaz (Turkey), Campinas (Brazil), Jurong (Singapore) and Hangzhou (China) for General Medicines; and •Marcy-l’Étoile and Val-de-Reuil (France), Toronto (Canada) and Swiftwater (US) for Vaccines. Research & Development sites In Pharmaceuticals, research and development activities are conducted at the following sites: •two operational sites in France: Montpellier and Vitry-sur-Seine/Alfortville; •two sites in the rest of Europe (Germany and Belgium), the larger of which is in Frankfurt (Germany); •three sites in the US: Bridgewater, Cambridge and Framingham/Waltham ; and •three sites in China (Beijing, Shanghai and Chengdu). In Vaccines, research and development activities are conducted at the following sites: •Swiftwater, Cambridge and Orlando (US); •Marcy-l’Étoile/Lyon (France); and •Toronto (Canada). D.3. Acquisitions, capital expenditures and divestitures The carrying amount of our property, plant and equipment at December 31, 2025 was €10,052 million. During 2025, we invested €1,822 million (see Note D.3. to our consolidated financial statements, included at Item 18. of this annual report), mainly in increasing capacity and improving productivity at our various production and R&D sites. Our principal acquisitions, capital expenditures and divestitures in 2023, 2024 and 2025 are described in Notes D.1. and D.2. (“Changes in the scope of consolidation”), D.3. (“Property, plant and equipment”) and D.4. (“Goodwill and other intangible assets”) to our consolidated financial statements, included at Item 18. of this annual report. For associated commitments, and in particular future contingent milestone payments, refer to Notes D.18 and D.21. to our consolidated financial statements, which provide disclosures about liabilities related to business combinations and our principal research and development collaboration agreements, respectively. As of December 31, 2025, our firm commitments in respect of future capital expenditures amounted to €926 million. The principal locations involved are: for medicines, the industrial facilities at Frankfurt (Germany); Le Trait, Lyon, Aramon, Sisteron and Vitry (France); Cambridge (US); Geel (Belgium); Waterford (Ireland); Anagni and Scoppito (Italy); Shuand Xi (China); and for vaccines, the facilities at Swiftwater (US); Toronto (Canada); Marcy-l’Étoile, Neuville-sur-Saône and Val-de-Reuil (France); and Tuas (Singapore). In the medium term and assuming no changes in the scope of consolidation, we expect to invest on average approximately €1.75 billion a year in property, plant and equipment. We believe that our own cash resources and the undrawn portion of our existing credit facilities will be sufficient to fund these expenditures. Our principal ongoing capital expenditures are described below. Medicines Our Medicines industrial operations are organized through end-to-end clusters. We have four dedicated biotechnology hubs: Paris/Lyon (France), Frankfurt (Germany), Geel (Belgium) and the Boston area (US). Exploiting innovative techniques, including cell and microbiological culture and the development of viral vectors, our biotechnology operations call for highly specific knowledge and expertise backed by dedicated production platforms to support global product launches. We also have end-to-end clusters with chemistry, pharmaceutical and injectable sites organized through a network of regional and local industrial sites, supporting growth in those markets. A dedicated Launch Sites cluster has been implemented, from API manufacturing to finished goods packaging (Sisteron, Aramon, Ambarès, Scoppito). The Frankfurt facility is our principal site for the manufacture of diabetes treatments. Also in 2024, we announced major investments in the production of insulin APIs, at new facilities in Frankfurt (Germany) and Beijing (China). SANOFI FORM 20-F 2025 55 PART I ITEM 4. Information on the Company Vaccines The industrial operations of our Vaccines business are in a major investment phase, preparing for the upcoming growth of our influenza and Polio/Pertussis/Hib franchises, plus the mid-term growth linked to our mRNA roadmap and New Vaccines pipeline. Major investments were announced in 2020 and 2021 with a new Evolutive Facility in France (Neuville-Sur-Saone) and a new facility in Singapore for our New Vaccines pipeline. Other major investments are under way in France (including construction of a new influenza vaccine building at Val-de-Reuil), Canada (a new pertussis vaccine building), the US and Mexico. Innovation and culture of industrial excellence The ambition of our Manufacturing & Supply department is to continue to raise safety, quality and operating standards in Sanofi’s production activities, and to remain a world leader and a benchmark in the global pharmaceutical industry. To achieve this goal, all our activities share a common culture of industrial excellence, enshrined in the Sanofi Manufacturing System. This sets out a series of priorities (such as customer service, constant improvement, site network optimization and transverse optimization) that constitute our industrial vision and will be crucial to our mutual success. In terms of operational excellence, we continue to build on our Top Decile performance program, focused on core sites and fully leveraging digital opportunities and technology innovations. We are also reinforcing the Sanofi Manufacturing System to drive more improvement directly from the sites and reach our performance goals, while creating a culture of best practices shared across the industrial network. 56 SANOFI FORM 20-F 2025 PART I ITEM 4. Information on the Company E. R&D Appendix R&D Pipeline Registration Name Description Indication Dupixent(a) IL4R mAb Allergic fungal rhinosinusitis (US)Bullous pemphigoid (EU, JP) teplizumab CD3 mAb Type 1 diabetes, stage 3 (US) Wayrilz BTK inhibitor Immune thrombocytopenia (JP) tolebrutinib BTK inhibitor Secondary progressive MS (US, EU) Sarclisa CD38 mAb subcutaneous Relapsed/refractory MM Phase 3 Name Description Indication Name Description Indication Immunology Rare diseases amlitelimab OX40L mAb Atopic dermatitis Nexviazyme Enzyme replacement therapy Infantile-onset Pompe disease Dupixent (a) IL4R mAb Chronic pruritus of unknown originLichen simplex chronicus elenestinib D816V-mutated KIT inhibitor Indolent/smoldering systemic mastecytosis duvakitug (b) TL1A mAb Crohn’s diseaseUlcerative colitis fitusiran RNAi targeting anti-thrombin Hemophilia A and B (EU, JP) itepekimab (a) IL33 mAb Chronic obstructive pulmonary disease (1) Chronic rhinosinusitis with nasal polyps Wayrilz BTK inhibitor Sickle cell diseaseIgG4-related diseaseWarm autoimmune hemolytic anemia lunsekimig IL13×TSLP Nanobody® VHH Chronic obstructive pulmonary disease venglustat Oral GCS inhibitor Fabry diseaseGaucher disease type 3 Rezurock ROCK2 inhibitor Chronic lung allograft dysfunction Neurology Oncology frexalimab (c) CD40L mAb Relapsing MSNon-relapsing secondary progressive MS Sarclisa CD38 mAb NDMM, TE (HD7) (US)NDMM, TE (IsKia)Smoldering MM (ITHACA) riliprubart C1s mAb SOC-refractory CIDPIVIg-treated CIDP Vaccines SP0087 Vero cell vaccine Rabies SP0218 Vero cell vaccine Yellow fever Fluzone HD Multivalent inactivated vaccine Flu (50 years+) SP0202(d) 21-valent conjugate vaccine Pneumococcal disease (children) (1) itepekimab’s future development in COPD is dependent on further analysis of Phase 3 data and regulatory feedback. Collaborations: (a) Regeneron; (b) Teva Pharmaceuticals; (c) ImmuNext; (d) SK biosience. Abbreviations: BTK: Bruton’s tyrosine kinase – CD: Cluster of differentiation – C1s: Complement component 1s – CIDP: Chronic inflammatory demyelinating polyneuropathy – CN: China – EU: Europe – GCS: Glucosylceramide synthase – HD: High dose – IgG4: Immunoglobulin G4 – IL: Interleukin – IVIg: Intravenous immunoglobulin – JP: Japan – mAb: Monoclonal antibody - MM: Multiple myeloma - MS: Multiple sclerosis - NDMM: Newly diagnosed multiple myeloma - RNAi: RNA interference - ROCK2: Rho Associated coiled-coil containing protein kinase 2 – SOC: Standard of care – TE: Transplant eligible – TL1A: Tumor necrosis factor-like cytokine 1A – TSLP: Thymic stromal lymphopoietin SANOFI FORM 20-F 2025 57 PART I ITEM 4. Information on the Company Phase 2 Name Description Indication Name Description Indication Immunology Rare diseases amlitelimab OX40L mAb Asthma Wayrilz BTK inhibitor Graves' disease balinatunfib oral TNFR1 signaling inhibitor Crohn’s disease Ulcerative colitis efdoralprin alfa AAT fusion protein Alpha-1 antitrypsin deficiency emphysema brivekimig TNFa×OX40L Nanobody® VHH Crohn’s disease Hidradenitis suppurativaUlcerative colitisType 1 diabetes, stage 3 frexalimab rilzabrutinib brivekimig CD40L mAbBTK inhibitorTNFa×OX40L Nanobody® VHH Focal segmental glomerulosclerosis/minimal change disease frexalimab(a) CD40L mAb Type 1 diabetes itepekimab(b) IL33 mAb Chronic rhinosinusitis without nasal polyps Oncology lunsekimig IL13×TSLP Nanobody® VHH AsthmaAsthma, high-risk Atopic dermatitisChronic rhinosinusitis with nasal polyps SAR445877 PD1×IL15 fusion protein Solid tumors riliprubart C1s mAb Antibody-mediated rejection Sarclisa CD38 mAb Relapsed/refractory multiple myeloma in combination rilzabrutinib BTK inhibitor AsthmaChronic spontaneous urticaria SAR449028 Wild-type KIT inhibitor Chronic induced/spontaneous urticariaAllergic rhinoconjunctivitis Vaccines SAR444336 Non-beta IL2 Synthorin Microscopic colitis SP0230 5-valent (ACWY+B) vaccine Meningitis SAR445399 (1) IL1R3 mAb Hidradenitis suppurativa SP0256 mRNA vaccine RSV+hMPV (older adults) SP0268 mRNA vaccine Acne Neurology SP0289 mRNA vaccine Flu H5 pandemic SAR402663 sFLT01 AAV gene therapy Wet age-related macular degeneration SP0335 Inactivated adjuvanted vaccine Flu H5 pandemic Phase 1 Name Description Indication Name Description Indication Immunology Oncology SAR446422 CD28×OX40 bispecific Ab Inflammatory indication SAR445953 (d) CEACAM5-Topo1 ADC Colorectal cancer SAR446959 MMP13×ADAMTS5×CAP Nanobody® VHH Knee osteoarthritis SAR446523 GPRC5D mAb Relapsed/refractory multiple myeloma SAR448501 CD20 bispecific mAb Inflammatory indication SAR448755 (c) STAT6 inhibitor Inflammatory indication Vaccines SP0287 Fluzone HD+Nuvaxovid Flu+COVID-19 Neurology SP0287 Flublok+Nuvaxovid Flu+COVID-19 SAR446597 Bb×C1s AAV gene therapy Geographic atrophy in dry age-related macular degeneration SP0291 mRNA vaccine RSV+hMPV+PIV3 (older adults) SAR448851 TREM2 agonist Alzheimer’s disease SP0269 mRNA vaccine Chlamydia SP0340 Subunit vaccine RSV+hMPV (older adults) SP0341 Subunit vaccine RSV+hMPV+PIV3 (older adults) Rare diseases SAR446268 DMPK AAV gene therapy Myotonic dystrophy type 1 (1) Also known as MAB212, in-licensed from MAB Discovery. Collaborations: (a) ImmuNext; (b) Regeneron; (c) Recludix; (d) Pfizer Abbreviations: AAT: Alpha–1 antitrypsin – AAV: Adeno-associated virus – Ab: Antibody – ADAMTS5: A Disintegrin And Metalloproteinase with Thrombospondin Motifs 5 – ADC: Antibody-drug conjugate – Bb: Factor Bb – BTK: Bruton’s tyrosine kinase – C1s: Complement component 1s – CAP: Cartilage anchoring protein – CD: Cluster of differentiation – CEACAM5: Carcinoembryonic antigen cell adhesion molecule 5 – DMPK: dystrophia myotonica protein kinase 1 – GPRC5D: G- protein-coupled receptor class 5 member D – H5: hemagglutinin 5 - hMPV: human Metapneumovirus – IL: Interleukin – IL1R3: Interleukin-1 receptor 3 – mAb: Monoclonal antibody – MMP13: Matrix metallopeptidase 13 – mRNA: messenger RNA – PD1: Programmed death protein 1 – PIV3: Parainfluenza virus type 3 – RSV: Respiratory syncytial virus – STAT6: Signal transducer and activator of transcription 6 – TNFa: Tumor necrosis factor alpha – TNFR1: Tumor necrosis factor receptor 1 – Topo1: Topoisomerase - TREM2: triggering receptor expressed on myeloid cells 2 – TSLP: Thymic stromal lymphopoietin 58 SANOFI FORM 20-F 2025 PART I ITEM 4A. Unresolved Staff Comments