Half-year management report 4. Responsibility statement of the certifying officer half-year financial report "I hereby certify that, to the best of my knowledge, the condensed half-year consolidated financial statements

2. Half-year management report

A Significant events of the first half of 2025

A.1. First-half overview

During the first half of 2025, Sanofi continued to implement its growth and innovation strategy, focused on launching major innovations, reallocating resources and developing cutting-edge R D. Significant events connected with the implementation of this strategy are described below (for additional information on developments related to Research and Development see also section A.2. Research and Development ).

During the meeting of the Board of Directors on January 29, 2025, the Board authorized Sanofi to repurchase the Company's shares, for an amount not exceeding 5 billion, under the terms and conditions set by the General Meeting of April 30, 2024 in its 19th resolution. As part of this authorization, Sanofi entered into a share buyback agreement with its historical shareholder L'Or al on February 2, 2025 for the acquisition of 2.34% of Sanofi's share capital, equivalent to 29,556,650 shares, for a total amount of approximately 3 billion, representing a price of 101.50 per share. The conclusion of that agreement was approved by the Board of Directors on the same day prior to the signing of the agreement, and in accordance with the procedure set forth in Articles L. 225-38 et seq. of the French Commercial Code. In addition, on February 6, 2025 Sanofi entered into a mandate with an investment services provider to repurchase its own shares for a maximum amount of 2 billion, between February 7, 2025 and December 31, 2025.

As part of the Euro Medium Term Note program, Sanofi carried out two bond issues in the first half of 2025. On March 5, a first issue of 1.5 billion was completed, comprising 850 million of floating-rate bonds (3-month Euribor + 0.300%) maturing in March 2027, and 650 million of fixed-rate bonds (2.750% per annum) maturing in March 2031. On June 17, a second issue of 1.5 billion was completed, consisting of two tranches of 750 million each one at a fixed rate of 2.625% per annum) maturing in June 2029, and the other at a fixed rate of 3.000% per annum maturing in June 2032. Sanofi will use the net proceeds from the issuance of these bonds for general corporate purposes.

On April 30, 2025, Sanofi announced the completion of the transaction with Clayton, Dubilier Rice (CD R) relating to Sanofi's consumer healthcare business, Opella. Sanofi retains a 48.2% equity interest in OPAL JV Co, which indirectly holds 100% of Opella.. Bpifrance holds a minority stake of 1.8% and will be represented on Opella's Board. As a result of the transaction, Sanofi has recognized a net gain of 2.7 billion, reported within the line item Net income from discontinued operations in the consolidated income statement. Sanofi has received total net cash proceeds of 10.7 billion, presented within the line item Net cash inflow from the Opella transaction in the statement of cash flows.

On May 22, 2025, Sanofi announced that it had entered into an agreement to acquire Vigil Neuroscience, Inc. ("Vigil"), a US-based publicly traded clinical-stage biotechnology company focused on developing novel therapies for neurodegenerative diseases. This acquisition in neurology enhances Sanofi's early-stage pipeline and includes VG-3927, an oral small molecule TREM2 agonist currently in development for Alzheimer's disease. Sanofi had previously invested $40 million in June 2024, including a pre-emptive right to VG-3927. Sanofi will acquire all outstanding common shares of Vigil for $8 per share in cash at closing. Based on $8.00 per share, the total equity value of Vigil represents approximately $470 million (on a fully diluted basis). Closing of the transaction is expected in the third quarter of 2025 subject to conditions customary for such a transaction, including the approval of holders of a majority of the outstanding shares of Vigil common stock the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary conditions.

On May 27, 2025, Sanofi announced the completion of the acquisition of DR-0201, a targeted bispecific antibody developed by Dren Bio, Inc., a privately held clinical-stage biopharmaceutical company. The definitive agreement was signed on March 19, 2025. DR-0201, now named SAR448501, engages myeloid cells for robust B-cell depletion, as demonstrated in preclinical and early clinical studies. Under the merger agreement, Sanofi acquired Dren-0201, a subsidiary of Dren Bio, for an upfront payment of $600 million, supplemented by potential milestone payments of up to $1.3 billion contingent upon attainment of development and commercialization milestones.

On June 2, 2025, Sanofi and Blueprint Medicines Corporation (Blueprint), a US-based, publicly traded biopharmaceutical company specializing in systemic mastocytosis (SM), a rare immunological disease, and other KIT-driven diseases, entered into an agreement under which Sanofi agreed to acquire Blueprint.

The acquisition included a rare immunology disease medicine, Ayvakit Ayvakyt (avapritinib), approved in the US and the EU, and a promising advanced and early-stage immunology pipeline. Blueprint's established presence among allergists, dermatologists, and immunologists is expected to enhance Sanofi's growing immunology pipeline.

Under the terms of the acquisition, Sanofi agreed to pay $129.00 per share in cash at closing, representing an equity value of approximately $9.1 billion for 100% of the shares. Blueprint shareholders also received one non-tradable contractual contingent value right (CVR) per share which entitles the holder to receive two potential milestone payments of $2.00 and $4.00 per CVR on the attainment of future development and regulatory milestones within the applicable milestone period, respectively, for BLU-808. The total equity value of the transaction, including potential CVR payments, represents approximately $9.5 billion on a fully diluted basis. In July 2025, Sanofi obtained control of Blueprint after all tender offer and merger conditions had been met.

Net sales for the first half of 2025 amounted to 19,889 million, 8.3% higher than in the first half of 2024. At constant exchange rates (CER)(1), net sales rose by 9.9%, driven mainly by strong performances for Dupixent, ALTUVIIIO and Beyfortus.

Net income attributable to equity holders of Sanofi amounted to 5,812 million in the first half of 2025, versus 2,246 million in the first half of 2024. Earnings per share was 4.74 for the first half of 2025, versus 1.80 for the first half of 2024. Business net income(2) was 4,152 million, up 7.6% on the first half of 2024, while business earnings per share (business EPS(2)) was 3.39, 9.7% up on the first half of 2024.

A.2. Research and development

During the first half of 2025, Sanofi maintained its R D efforts with the aim of improving quality of life for people around the globe by developing innovative vaccines and medicines.

Progress made in R D during the period is described in detail below, and an update on the R D pipeline is presented in Section G of this half-year management report.

Dupixent (dupilumab)

After evaluation under priority review by the US Food and Drug Administration (FDA), Dupixent was approved for the treatment of adult patients with bullous pemphigoid (BP), a chronic, debilitating, and relapsing skin disease with underlying type-2 inflammation that typically occurs in an elderly population. The approval is based on data from the pivotal ADEPT phase 2 3 study that evaluated the efficacy and safety of Dupixent compared to placebo in adults with moderate-to-severe BP. Additional regulatory applications are under review around the world, including in the European Union (EU), Japan, and China.

Dupixent was granted marketing and manufacturing authorization in Japan for the treatment of chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately controlled with existing therapy. The approval in Japan was based on data from the BOREAS phase 3 study.

itepekimab (IL33 mAb)

The AERIFY-1 phase 3 study evaluating itepekimab in former smokers with inadequately controlled chronic obstructive pulmonary disease (COPD) met the primary endpoint of a statistically significant reduction in moderate or severe acute exacerbations compared to placebo of 27% at week 52, a clinically meaningful benefit. With a reduction of only 2% at week 52, the AERIFY-2 phase 3 study did not meet the same primary endpoint. In the studies, patients were randomized to receive itepekimab every two weeks, every four weeks, or placebo, which was added to inhaled triple or double standard-of-care therapy. The safety of itepekimab was consistent across the studies, and adverse events were generally comparable between treatment and placebo groups. Sanofi and Regeneron are reviewing the data, including the apparent loss of benefit in AERIFY-2, and will discuss with regulatory authorities to evaluate next steps.

The CEREN 1 and CEREN 2 phase 3 studies of two dose regimens of itepekimab compared with placebo as add-on therapy to intranasal corticosteroids in patients with inadequately controlled CRSwNP commenced dosing the first patients.

amlitelimab (CD40 mAb)

The COAST 1 and SHORE phase 3 studies, part of the OCEANA study program in atopic dermatitis (AD), have completed patient recruitment ahead of schedule. Patient recruitment proceeded efficiently, providing an opportunity to optimize the overall sample sizes and robustness of the studies. The OCEANA program is anticipated to read out in 2025 (initial data) and 2026 (full data) and will provide the foundation for potential regulatory submissions.

Rezurock (belumosudil)

Based on a pre-specified interim analysis, a decision was made to discontinue the ROCKnrol-1 phase 3 study evaluating belumosudil in first-line chronic graft-versus-host disease. No major safety concerns were identified.

riliprubart (C1s mAb)

The US FDA granted orphan drug designation to riliprubart for the treatment of antibody-mediated rejection (AMR) in solid organ transplantation. This designation reflects Sanofi's commitment to addressing a critical unmet need in transplant medicine, where AMR remains a significant challenge with no FDA-approved treatments available.

The US FDA approved Qfitlia, the first antithrombin (AT)-lowering medicine for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (aged 12 or older) with hemophilia A or B with or without factor VIII or IX inhibitors. The approval is based on data from the ATLAS phase 3 studies that demonstrated clinically meaningful bleed protection as measured by annualized bleeding rates across hemophilia patients with or without inhibitors. In conjunction with

(1) Non-IFRS financial measure see definition in D.3., "Net sales".

(2) Non-IFRS financial measure see definition in D.2., "Business net income".

the Qfitlia approval, the FDA also cleared Siemens Healthineers' INNOVANCE AT assay as a companion diagnostic for Qfitlia to measure AT levels. The medicine is also under regulatory review in China.

Cerezyme (imiglucerase)

The US FDA accepted for review the submission of a supplemental biologics license application (sBLA) for Cerezyme to treat patients with Gaucher disease type 3 (GD3), with no age limitation, for patients with GD1 and GD3. The FDA decision is expected in the first quarter of 2026.

rilzabrutinib (BTK inhibitor)

The US FDA granted orphan drug designation to rilzabrutinib, a novel, advanced, oral, reversible Bruton's tyrosine kinase (BTK) inhibitor that works via multi-immune modulation to target a reduction in vaso-occlusive crises (which may occur via inflammation), in sickle cell disease.

tolebrutinib (BTK inhibitor)

The US FDA is evaluating under priority review the regulatory submission of tolebrutinib, the submission of which was accepted in the first half 2025, to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) and to slow disability accumulation independent of relapse activity. The FDA decision is expected before the end of 2025. A regulatory submission has also been accepted and is under review in the EU. The positive results from the HERCULES phase 3 study that form the basis for these regulatory submissions were published in the New England Journal of Medicine (NEJM) in April 2025. As part of the ongoing regulatory review, discussions with the FDA and the EMA are continuing with respect to efficacy and safety, including liver safety, from the clinical studies.

riliprubart (C1s mAb)

In Japan, riliprubart was granted orphan drug designation for people with chronic inflammatory demyelinating polyneuropathy (CIDP). Despite available therapies, many CIDP patients are left with residual symptoms, including weakness, numbness, and fatigue that can lead to long-term morbidity and diminished quality of life. Approximately 30% of people with CIDP do not respond to standard therapies. The orphan drug designation is granted to medicines that address rare medical diseases or conditions with unmet medical needs. There are currently approximately 4,000 people diagnosed with CIDP in Japan.

Sarclisa (isatuximab)

Following the adoption of a positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), Sarclisa in combination with the standard-of-care regimen bortezomib, lenalidomide, and dexamethasone (VRd) was approved in January in the EU for the treatment of adult patients with newly diagnosed multiple myeloma ineligible for autologous stem cell transplant (NDMM, TI). Sarclisa in combination with VRd was also approved in Japan and China for the treatment of adult patients with NDMM, TI. These approvals are based on data from the IMROZ phase 3 study.

In January, Sarclisa in combination with pomalidomide and dexamethasone was approved in China for the treatment of adult patients with MM who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. This approval is based on results from the pivotal ICARIA-MM phase 3 study, using the China-based IsaFiRsT real-world study as bridging data.

Following the positive opinion by the CHMP, Sarclisa in combination with VRd was approved in the EU for the induction treatment of adult patients with NDMM who are eligible for autologous stem cell transplant. The positive CHMP opinion was based on part one results from the two-part, double-randomized, German-speaking Myeloma Multicenter Group (GMMG)-HD7 study.

Results from the IRAKLIA phase 3 study demonstrated that Sarclisa administered at a fixed dose subcutaneously (SC) via an on-body delivery system in combination with pomalidomide and dexamethasone (Pd) met its co-primary endpoints of non-inferior objective response rate and observed concentration before dosing at steady state compared to intravenous Sarclisa administered at a weight-based dose in combination with Pd in patients with relapsed or refractory (R R) MM. These results will be the basis for regulatory submissions in the US and in the EU in 2025. Additional studies evaluating Sarclisa SC formulations across different combinations and lines of therapy are ongoing.

MenQuadfi (meningitis, six weeks+)

In May, the US FDA updated MenQuadfi's approval, which now includes active immunization in children aged six weeks to 23 months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y.

Nuvaxovid (COVID-19)

Sanofi's collaboration partner Novavax, Inc. announced that the US FDA had approved the biologics license application (BLA) for Nuvaxovid for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults aged 65 years and older and individuals aged 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 (e.g. asthma, cancer, diabetes, obesity, smoking). Nuvaxovid has been available for use in the US under Emergency Use Authorization since July 2022 and has full market approvals in the EU, UK and other countries. Under a May 2024 agreement, Sanofi has a co-exclusive license to co-commercialize Nuvaxovid in most countries worldwide and a sole license to Nuvaxovid for use in combination with Sanofi's flu vaccines, currently in phase 1 clinical studies.

The phase 3 study of the vero cell vaccine for the prevention of rabies read out positively on safety and immunogenicity. It is intended for use as a vaccine, and as a booster after two to three years. This study and previous studies support a US regulatory submission for prevention of rabies before and after exposure in all populations in the second half of 2025.

SP0282 (E. coli sepsis)

In February, a scheduled review of the E.mbrace phase 3 study conducted by an independent data monitoring committee (IDMC) determined that Sanofi's and Johnson Johnson's vaccine candidate for extraintestinal pathogenic E. coli was not sufficiently effective at preventing invasive E. coli disease (IED) compared to placebo. No safety signals related to the vaccine candidate were identified and, throughout the study, investigators ensured that participants who developed IED received prompt treatment and care. As a result of the IDMC's determination, the E.mbrace study was discontinued.

SP0218 (yellow fever)

A vaccine candidate is in development to prevent yellow fever infection in populations aged nine months and older. A phase 3 study in adults has commenced dosing the first patient.

A.3. Other significant events

A.3.1 Corporate governance

The Combined General Shareholders' Meeting of Sanofi was held on April 30, 2025 at the Palais des Congr s in Paris, and was chaired by Fr d ric Oud a. All resolutions submitted to the vote were adopted by the shareholders. Decisions taken by the General Meeting included approving the individual company and consolidated financial statements for the year ended December 31, 2024 and distributing an ordinary annual dividend of 3.92 per share. The meeting also approved the reappointment of Carole Ferrand, Barbara Lavernos, Emile Voest and Antoine Yver as directors, and ratified the co-opting of Jean-Paul Kress. On a proposal from the Appointments, Governance and CSR Committee, the Board of Directors appointed Clotilde Delbos, independent director, as Chairwoman of the Compensation Committee she succeeds Patrick Kron, who will remain as a member of the Committee. Following the expiry of Fabienne Lecorvaisier's term of office at the close of the Annual General Meeting of April 30, 2025, the Board of Directors now comprises 16 members, of whom six are women and two are directors representing employees. The Board of Directors retains a large majority of independent directors.

A.3.2. Legal and arbitration proceedings

For a description of the most significant developments in legal and arbitration proceedings since publication of the financial statements for the year ended December 31, 2024, refer to Note B.14. to our condensed half-year consolidated financial statements.

US Department of Health and Human Services (HHS), Office of Inspector General (OIG) Philadelphia Subpoena

In May 2025, Sanofi US received a subpoena from the Philadelphia Office of the US Department of Health and Human Services Office of Inspector General (HHS-OIG). The subpoena seeks information about Sanofi's agreements with pharmacy benefit managers (PBMs) and group purchasing organizations (GPOs), particularly regarding the provision of drug utilization data from 2020 to the present.

The investigation is being conducted jointly by the US Department of Justice (DOJ), the US Attorney's Office for the Eastern District of Pennsylvania, and the HHS-OIG. Sanofi is cooperating with this investigation.

US Department of Justice (DOJ) - Civil Investigative Demand (CID) - Beyfortus

In March 2025, Sanofi US received a CID (Civil Investigative Demand) from the US Department of Justice under the False Claims Act. The CID requests information related to the RSV (Respiratory Syncytial Virus) vaccine Beyfortus, which Sanofi co-develops and co-commercializes with a partner company. The CID specifically references a May 2024 FDA inspection of a manufacturing facility in North Carolina where Beyfortus was filled into syringes. Sanofi is cooperating fully and providing the requested information.

On June 5, 2025. Sanofi announced the launch of Action 2025, a global employee share ownership plan open to around 70,000 employees in 55 countries. Now in its eleventh year, the program demonstrates the ongoing commitment of Sanofi and its Board of Directors to ensuring that employees benefit from the company's growth and success.

The shares were offered at a subscription price of 72.97, representing a 20% discount to the average of the 20 opening prices of Sanofi shares from May 7 to June 3, 2025. For every five shares subscribed, employees were entitled to receive one free share (up to a maximum of four free shares per employee). Every eligible employee was able to purchase up to 1,500 Sanofi shares, subject to the maximum legal limit set at 25% of their gross annual salary, minus any voluntary deductions already made under employee savings schemes such as the Company Savings Plan and or Group Savings Plan and or Group Retirement Savings Plan (PERCO) during 2025 the above limit does not apply to voluntary contributions to the "PERCOL" retirement savings plan.

B Progress on implementation of the corporate social responsibility strategy

Introducing AIR Sanofi's updated sustainability strategy

Building on a foundation in corporate social responsibility, Sanofi is introducing an updated sustainability strategy focused on the critical nexus between health and the environment. The AIR strategy addresses three key dimensions

Access to healthcare expanding sustainable and equitable access to care programs for conditions impacted by environmental challenges, with initial focus on respiratory health and diabetes

Environmental impact reducing the environmental impact of Sanofi's medicines and vaccines and activities across the value chain while adapting to climate- and nature-related changes, with the ambition to reach Net Zero greenhouse gas emissions by 2045 and

Resilience of healthcare systems transforming the delivery of care through treatments and collective efforts that reduce the environmental footprint of healthcare systems.

This strategic focus recognizes that 70% of Sanofi's medicine and vaccine portfolio, and more than 75% of Sanofi's pipeline, target diseases that are impacted by climate and environmental challenges. It also puts Sanofi in a position to make a meaningful difference through access to care programs and actions to reduce the environmental footprint of healthcare. In these ways, Sanofi can help break the vicious circle between environmental degradation and declining human health.

Reducing the environmental footprint of healthcare from ambition to results

With 3.6 billion people living in areas sensitive to climate change globally(1), Sanofi aims to reduce the environmental footprint of its medicines and vaccines via an eco-design approach, spanning the entire lifecycle - from raw materials, manufacturing, device and packaging, all the way to distribution, patient use, and end of life.

Starting in 2025, all new medicines and vaccines are adopting an eco-design approach, and by 2030, so will Sanofi's 20 top sellers. Leveraging a science-based life cycle assessment methodology(2) and its own ISO-compliant eco-design digital intelligence tool, Sanofi has already achieved results in some of its top-selling medicines and vaccines

For Dupixent(3), the carbon footprint was reduced by 53%, water use cut by 62% and resource depletion reduced by 30%, by optimizing the active ingredient manufacturing process with the partner Regeneron.

For Toujeo(3), 27% carbon footprint reduction, 11% water savings, and 18% resource reduction were achieved through improved manufacturing, packaging, and device production.

For Hexaxim(3), production and packaging were also optimized, resulting in 17% lower carbon footprint, 19% less water use, and 6% fewer resources used.

All measures were compared to the previous generation of those medicines and vaccines. These improvements demonstrate our commitment to reducing environmental impact across ours product range.

Decarbonizing patient care pathways

The healthcare sector generates approximately 5% of global greenhouse gas emissions, with about half of that attributable to the patient care pathway(4). As a key player, Sanofi has the capacity to lead efforts to reduce emissions related to the patient journey.

Sanofi is intensifying its efforts to generate and analyze data that examine how its treatments can help decarbonize patient care pathways. Sanofi has already identified several ways to reduce environmental impact across patient care such as prioritizing prevention, optimizing treatments, and improving care settings.

In a recent study conducted in Spain using real-world evidence, Sanofi demonstrated the positive environmental impact of the all-infant 2023-2024 immunization program against RSV with Beyfortus(5). With immunization coverage exceeding 90% for in-season births and approaching 90% for out-of-season births(6), RSV prevention contributed to lower greenhouse gas emissions through reduced healthcare system utilization and decreased patient transportation, as evidenced by fewer visits to primary care physicians, emergency rooms, and specialists, as well as reduced hospitalizations. The program reduced RSV-related CO2 emissions by 47% compared to the previous year's standard of care, equivalent to 4.9 kilotons of CO2.

Sustainability dashboard for the second quarter of 2025

Please refer to the sustainability dashboard provided as an appendix to the Sanofi second-quarter 2025 results press release.

(1) World Health Organization newsroom fact sheet on climate change key facts October 12, 2023.

(2) European Platform on environmental life cycle assessment https eplca.jrc.ec.europa.eu EnvironmentalFootprint.html.

(3) Based on an ISO-compliant life cycle assessment study peer-reviewed by independent panels, ensuring transparent and accurate results.

(4) Information from White Paper issued by the Sustainable Markets Initiative health systems task force, https a.storyblok.com f 109506 x 88fe7ea368 smi-hstf-pcp-whitepaper.pdf.

(5) Sanofi Beyfortus health-economic model, Gil-Prieto et al. 2024, CVA analysis ICAO 2024 data, CVA.

(6) Data from the Spanish Ministry of Health (2024), https www.sanidad.gob.es areas promocionPrevencion vacunaciones comoTrabajamos docs VRS_infantil.pdfb.