You should read the following discussion in conjunction with our consolidated financial statements and the notes thereto included at Item 18. of this annual report. Our consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB) and with IFRS endorsed by the European Union as of December 31, 2025. The following discussion contains forward-looking statements that involve inherent risks and uncertainties. Actual results may differ materially from those contained in such forward-looking statements. See “Cautionary Statement Regarding Forward- Looking Statements” at the beginning of this document. Unless otherwise stated, all financial variations in this item are given on a reported basis. The discussion of our operating and financial review and prospects for the years ended December 31, 2024 and December 31, 2023, including a presentation of our consolidated income statements for the years ended December 31, 2024 and December 31, 2023, can be found in “Item 5. Operating and Financial Review and Prospects — A. Operating results — A.2. Results of operations — Year ended December 31, 2024 compared with year ended December 31, 2023” of our annual report on Form 20-F filed on February 13, 2025. A. Operating results A.1. Significant operating information A.1.1. 2025 Overview 2025 Business Developments In 2025, Sanofi introduced the “Take the Lead” strategy to accelerate transformative impact for patients, healthcare systems, and society, reinforcing its position as an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. For further information about our strategy, refer to “Item 4. Information on the Company — B. Business Overview — B.1. Strategy.” Other significant events of the year are described below. During the meeting of the Board of Directors on January 29, 2025, the Board authorized Sanofi to repurchase an aggregate amount of the Company's own shares not exceeding €5 billion, under the terms and conditions set by the General Meeting of April 30, 2024 in its 19th resolution. Pursuant to this authorization, Sanofi entered into a share buyback agreement with its historical shareholder L'Oréal on February 2, 2025 for the acquisition of 2.34% of Sanofi’s share capital, equivalent to 29,556,650 shares, for a total repurchase price of approximately €3 billion, representing a price of €101.50 per share. Following the buyback, these shares were canceled during 2025 (see Note D.15.1. Share capital to our consolidated financial statements included at Item 18. of this annual report). In addition, on February 6, 2025 Sanofi entered into a mandate with an investment services provider to repurchase its own shares for a maximum aggregate amount of €2 billion between February 7, 2025 and December 31, 2025. The share buyback program had been executed in full by the end of 2025. As part of its 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 (2.75% 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 3.00% 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 closing of the transaction with Clayton, Dubilier & Rice (CD&R) relating to Sanofi’s consumer healthcare business, Opella. In accordance with the terms announced on February 19, 2025, Sanofi has transferred a controlling stake in Opella to CD&R. Sanofi retains a 48.2% equity interest in the associate OPAL JV Co, which indirectly holds 100% of Opella. Bpifrance holds a minority stake of 1.8% and is represented on Opella’s Board of Directors. 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 May 22, 2025, Sanofi announced that it had entered into an agreement to acquire Vigil Neuroscience, Inc. (Vigil), a publicly traded clinical-stage biotechnology company focused on developing novel therapies for neurodegenerative diseases. This acquisition in neurology, one of Sanofi’s four strategic disease areas, enhances Sanofi’s early-stage pipeline and includes VG-3927, which will be evaluated in a phase 2 clinical study in Alzheimer’s disease. VG-3927 is an oral small molecule TREM2 agonist. Activating TREM2 is expected to enhance the neuroprotective function of microglia in Alzheimer’s disease. Under the terms of a share purchase agreement (including the exclusive right of first negotiation for an exclusive license to VG-3927 or for SANOFI FORM 20-F 2025 59 PART I ITEM 5. Operating and Financial Review and Prospects transfer of the rights to research, develop, manufacture, and commercialize VG-3927) entered into by Sanofi and Vigil in June 2024 for an amount of $40 million, Sanofi already held an equity interest in Vigil, representing approximately 12% of Vigil’s share capital. That equity interest was remeasured through Other comprehensive income. VGL101, Vigil’s second molecule program, was not acquired by Sanofi. On August 5, 2025, Sanofi acquired all outstanding common shares of Vigil for $8.00 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). On May 27, 2025, Sanofi announced the completion of its acquisition of 100% of Dren-0201, Inc., a subsidiary of the privately held clinical-stage biopharmaceutical company Dren Bio, Inc. (Dren Bio), further to a definitive agreement signed on March 19, 2025. The acquired entity owns DR-0201, a targeted bispecific antibody developed by Dren Bio. DR-0201, now designated SAR448501, engages myeloid cells for robust B-cell depletion, as demonstrated in preclinical and early-stage clinical study data. Sanofi acquired Dren-0201, Inc. for an upfront payment of €539 million, supplemented by potential milestone payments of up to €1.2 billion subject to the achievement of development and commercialization objectives. On July 18, 2025, Sanofi announced the completion of its acquisition of Blueprint Medicines Corporation (Blueprint). The acquisition adds a market-available medicine, Ayvakit/Ayvakyt (avapritinib), to Sanofi’s portfolio along with a promising pipeline, and specialist expertise in the rare immune system disorder systemic mastocytosis (SM) and other diseases associated with the KIT gene. The acquisition includes elenestinib, a next-generation medicine for SM, as well as BLU-808, a highly potent and selective oral wild-type KIT inhibitor that has the potential to treat a broad range of diseases in immunology. Under the terms of the acquisition, Sanofi paid $129.00 per share in cash at closing, representing an equity value of approximately $9.1 billion on a fully diluted basis. Blueprint shareholders also received one non-tradeable and non-transferable contractual contingent value right (CVR) per share, which entitles the holders thereof 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 SAR449028 (formely known as BLU-808). The total equity value of the transaction, including potential CVR payments, represented approximately $9.5 billion on a fully diluted basis. With the acquisition of Blueprint, Sanofi gained an established presence among allergists, dermatologists, and immunologists, which is expected to strengthen our ability to advance our rapidly growing immunology pipeline. On July 22, 2025, Sanofi announced the signing of a definitive agreement to acquire Vicebio Ltd (Vicebio), a privately held biotechnology company based in London, UK, specializing in the development of next-generation respiratory vaccines. Under the terms of the agreement, Sanofi was to acquire all of Vicebio’s outstanding shares for an upfront payment of $1.15 billion, supplemented by potential milestone payments of up to $450 million, contingent upon the achievement of development and regulatory objectives. This acquisition provides Sanofi with an early-stage combination vaccine candidate against respiratory syncytial virus (RSV) and human metapneumovirus (hMPV), as well as innovative molecular clamp technology, which enables the quicker development of fully liquid combination vaccines that can be stored at standard refrigeration temperatures (2-8°C). After obtaining all necessary regulatory approvals, the acquisition was consummated on December 4, 2025. On September 24, 2025, Sanofi Ventures announced an additional $625 million multi-year capital commitment from Sanofi, increasing its total assets under management to over $1.4 billion. This new commitment to the evergreen venture fund builds on more than a decade of investing in innovative biotech and digital health companies that align with Sanofi’s long-term growth ambitions. On October 28, 2025, Sanofi announced that it had successfully placed its $3 billion bond issue across five tranches, including fixed and floating rate notes maturing between November 2027 and November 2032, with interest rates ranging from 3.75% to 4.20%. The notes were issued under Sanofi’s shelf registration statement filed with the SEC on April 4, 2024, and the net proceeds will be used for general corporate purposes. On December 19, 2025, Sanofi entered into an agreement with the US government aimed at reducing the cost of medications for American patients while strengthening the US role in bioproduction and pharmaceutical innovation. This voluntary and confidential agreement addresses the four requests made by President Trump in letters sent to pharmaceutical manufacturers on July 31, 2025. Specifically, Sanofi commits to aligning the Medicaid prices of certain medications with those in other high-income countries, expected to result in an average reduction of 61% for certain treatments (for diabetes, cardiovascular diseases, neurological diseases, and cancer). Sanofi will also offer direct access to patients through TrumpRx.gov with potential savings of up to 70%. In return, Sanofi is receiving a three-year period free from Section 232 tariffs on products imported by Sanofi into the US, while reaffirming its $20 billion investment in its US manufacturing capabilities. This agreement is expected to have no material impact on Sanofi's growth strategy or financial outlook during the period covered. On December 24, 2025, Sanofi announced that it had entered into an agreement to acquire Dynavax Technologies Corporation (Dynavax), a publicly traded vaccines company with (i) a marketed adult hepatitis B vaccine (HEPLISAV-B), currently marketed in the US, and (ii) a differentiated shingles vaccine candidate (Z-1018), currently in Phase 1/2 clinical development. Under the terms of the merger agreement, Sanofi will commence a cash tender offer to acquire all outstanding shares of Dynavax for $15.50 per share in cash, reflecting a total equity value of approximately $2.2 billion. Subject to the satisfaction or waiver of customary closing conditions, the acquisition is expected to close in the first quarter of 2026. (1)Non-IFRS financial measure: see definition in “— A.1.6. Presentation of net sales” below. (2)Non-IFRS financial measure: see definition in “— A.1.5. Segment information and net income — 3/ Business net income” below. 60 SANOFI FORM 20-F 2025 PART I ITEM 5. Operating and Financial Review and Prospects 2025 Financial results For further information about the biopharma products we sell, and about our research and development portfolio, refer to “Item 4. Information on the Company — B. Business Overview.” Our net sales for 2025 amounted to €43,626 million, an increase of 6.2% from 2024. At constant exchange rates (CER)(1), net sales rose by 9.9%, driven mainly by strong performances for Dupixent and increased sales of ALTUVIIIO. Net income attributable to equity holders of Sanofi amounted to €7,813 million for 2025, compared with €5,560 million in 2024, a €2,253 million increase. Earnings per share was €6.40 in 2025, compared with €4.44 in 2024. Business net income(2) was €9,555 million, up 7.2% on 2024, while business earnings per share (Business EPS(2)) was 10.0% higher than in 2024 at €7.83. At the Annual General Meeting on April 29, 2026, we will ask our shareholders to approve a dividend of €4.12 per share for the 2025 financial year, representing a payout of 52.6% of our business net income per share (see “— B.2. Consolidated balance sheet and debt.”). A.1.2. Impacts of competition from generics and biosimilars Some of our flagship products continued to suffer sales erosion in 2025 under the impact of competition from generics and biosimilars. We do not believe it is possible to state with certainty what level of net sales would have been achieved in the absence of generic competition. A comparison of our consolidated net sales for the years ended December 31, 2025 and 2024 (see “— A.2. Results of Operations — Year Ended December 31, 2025 Compared with Year Ended December 31, 2024” below) for the main products affected by generic and biosimilar competition shows a year-on-year loss of €353 million of net sales on a reported basis. However, other parameters can also contribute to the loss of sales, such as a fall in the average selling price of certain products. The table below sets forth the change by product. (€ million) 2025 2024 Change on areported basis Change on areported basis (%) Aprovel Europe 71 73 (2) -2.7% Lantus Europe 297 340 (43) -12.6% Lovenox Europe 455 567 (112) -19.8% Plavix Europe 88 91 (3) -3.3% Aubagio Europe 67 152 (85) -55.9% Mozobil Europe 8 39 (31) -79.5% Aubagio United States 135 187 (52) -27.8% Mozobil United States 4 12 (8) -66.7% Aprovel Japan 5 11 (6) -54.5% Plavix Japan 11 22 (11) -50.0% Total 1,141 1,494 (353) -23.6% We expect the erosion caused by generic competition to continue in 2026, with a negative impact on our net income. The products likely to be impacted in 2026 include those that already faced generic competition in 2025, but whose sales can reasonably be expected to be subject to further sales erosion in 2026 (see products listed in the table above). In addition, we have experienced generic competition for Aubagio in the US since March 2023 and in Europe since October 2023, with an intensification since 2024. The same pattern occurred for Mozobil with generic competition in the US since July 2023, and in Europe since early 2024. In 2025, aggregate consolidated net sales of those products in Europe, the US and Japan were €1,141 million; this comprised €986 million in Europe, €139 million in the US and €16 million in Japan. The negative impact on our 2026 net sales is likely to represent a substantial portion of those sales, but the actual impact will depend on a number of factors, such as the impact of generics and biosimilars on sales of our molecules, but also the market entry of generics of other molecules that are in competition with our products. In China, the authorities have implemented a range of healthcare cost containment measures, including the Volume Based Procurement (VBP) reverse auction that particularly impacts our insulin-based products, Plavix, Aprovel, and Lovenox (see also “Item 4. Information on the Company — B. Business Overview — B.5.4. Pricing & Reimbursement”). A large number of molecules were selected to submit tenders under successive waves of the VBP program, with the successful bidders being awarded a high level of market share in return for offering lower prices. The recent eleventh round of VBP results remained very unfavorable to multinational companies. Domestic generic companies confirmed the existing trend, and won the main bids due to further aggressive price reductions. (1)From 2024, Net sales excludes sales of Consumer Healthcare products, reclassified within Net income from discontinued operations for the years presented. SANOFI FORM 20-F 2025 61 PART I ITEM 5. Operating and Financial Review and Prospects A.1.3. Purchase accounting effects Our results of operations and financial condition for the years ended December 31, 2025 and 2024, have been significantly affected by our past acquisitions. See “— A.1.11. Critical accounting and reporting policies — 2/ Business combinations” below for an explanation of the impact of business combinations on our results of operations. Significant amortization of intangible assets has been generated by the following business combinations: Blueprint (€255 million in 2025); Genzyme (€51 million in 2025 and €152 million in 2024); Bioverativ (€590 million in 2025 and €630 million in 2024); Kadmon (€157 million in 2025 and €164 million in 2024); and Provention (€205 million in 2025 and €214 million in 2024). In order to isolate the purchase accounting effects of all acquisitions and the impact of certain other items, we use a non-IFRS financial measure that we refer to as “Business net income” (see definition and discussion of reconciliation to the IFRS financial measure Net income attributable to equity holders of Sanofi in “— A.1.5. Segment Information and Business Net Income — 3/ Business Net Income” below). A.1.4. Sources of revenues and expenses Revenues: Revenue arising from the sale of goods is presented in the income statement within Net sales. Net sales comprise revenue from sales of medicines, vaccines and active ingredients (1), net of sales returns, of customer incentives and discounts, and of certain sales-based payments paid or payable to the healthcare authorities. Returns, discounts, incentives and rebates are recognized in the period in which the underlying sales are recognized, as a reduction of sales revenue. See Note B.13.1. to our consolidated financial statements included at Item 18. of this annual report. We sell biopharma products directly, through alliances, and by licensing arrangements throughout the world. When we sell products directly, we record sales revenues as part of our consolidated net sales. When we sell products through alliances, the revenues reflected in our consolidated financial statements are based on the contractual arrangements governing those alliances. For more information about our alliances, see “— A.1.7. Financial Presentation of Alliances” below. Other revenues: all revenue that falls within the scope of IFRS 15 but does not relate to sales of Sanofi products is shown in this line item. It mainly comprises (i) royalties received from licensing intellectual property rights to third parties; (ii) VaxServe sales of products sourced from third-party manufacturers; and (iii) revenue received under agreements for Sanofi to provide manufacturing services to third parties. Royalties received under licensing arrangements are recognized over the period during which the underlying sales are recognized. VaxServe's operations include the distribution within the US of vaccines and other products manufactured by third parties. Other revenues is also used to recognize revenues generated from the manufacturing of Consumer Healthcare products on behalf of Opella entities. Until April 30, 2025, Opella entities were within the scope of discontinued operations (see Note B.7. to our consolidated financial statements included at Item 18. of this annual report). With effect from May 1, 2025, Opella entities are treated as related parties in accordance with IAS 24 (see Note D.6. to our consolidated financial statements included at Item 18. of this annual report). In addition, Other revenues includes revenues associated with Consumer Healthcare operations not transferred on the effective date of loss of control of Opella. These comprise primarily, but not exclusively, Consumer Healthcare activities that were not transferred on the effective date of loss of control of Opella, primarily (i) hospital sales of Opella products in China, the transfer of which will be finalized no earlier than 2028 after a transitional period required to complete the transfer plan agreed with Sanofi in the context of public tendering arrangements; (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). Cost of Sales. Our cost of sales consists primarily of the cost of purchasing raw materials and active ingredients, labor and other costs relating to our manufacturing activities, packaging materials, payments made under licensing agreements and distribution costs. We have license agreements under which we manufacture, sell and distribute products that are patented by other companies. When we pay royalties, we record them in Cost of sales. Operating Income. Our operating income reflects our revenues, our cost of sales and the remainder of our operating expenses, the most significant of which are research and development expenses and selling and general expenses. For our operating segment, we also measure our results of operations through an indicator referred to as “Business Operating Income,” which we describe below under “— A.1.5. Segment Information and Business Net Income — 2/ Business Operating Income.” A.1.5. Segment information and Business net income 1/ Segment information In accordance with IFRS 8 (Operating Segments), the segment information reported by Sanofi is prepared on the basis of internal management data provided to our Chief Executive Officer, who is the chief operating decision maker of Sanofi. The operating segment disclosures required under IFRS 8 are provided in Notes B.26. and D.35. to our consolidated financial statements included at Item 18. of this annual report. The segment information presented by Sanofi consists of a single operating segment: Biopharma. 62 SANOFI FORM 20-F 2025 PART I ITEM 5. Operating and Financial Review and Prospects 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 United States through the retained subsidiary Gold Bond LLC (holder of the associated worldwide property rights). 2/ Business operating income (non-IFRS financial measure) We report segment results on the basis of “Business operating income.” This non-IFRS indicator is used internally by Sanofi’s chief operating decision maker to measure the performance of our operating segment and to allocate resources. For a definition of “Business operating income”refer to Note D.35. to our consolidated financial statements included at Item 18. of this annual report. “Business operating income” is a non-IFRS financial measure and is reconciled with IFRS Operating income. In 2025, Operating income amounted to €6,344 million, versus €7,252 million for 2024, and our “Business operating income” amounted to €12,149 million, versus €11,343 million in 2024. The reconciliation between these two measures is presented in the table below. Because our “Business operating income” is not a standardized measure, it may not be directly comparable with the non-IFRS financial measures of other companies using the same or similar non-IFRS financial measures. Although management uses this non-IFRS measure to set goals and measure performance, it has no standardized meaning prescribed by IFRS. This non-IFRS measure is presented solely to permit investors to more fully understand how Sanofi’s management assesses underlying performance. This non-IFRS measure is not, and should not be viewed as, a substitute for IFRS measures, and should be viewed in conjunction with IFRS measures of our performance and financial position. Consequently, there may be limitations on the usefulness of this measure to investors. (€ million) 2025 2024 Operating income (IFRS) 6,344 7,252 Other gains and losses, and litigation(a) 255 470 Restructuring costs and similar items(b) 1,138 1,396 Expenses arising from the impact of acquisitions on inventories(c) 126 10 Fair value remeasurement of contingent consideration 104 96 Impairment of intangible assets(d) 2,241 248 Amortization of intangible assets 1,776 1,749 Net income attributable to non-controlling interests(e) (14) (14) Share of profit/(loss) from investments accounted for using the equity method(f) 179 136 Business operating income (non-IFRS) 12,149 11,343 (a)See Note D.28. to our consolidated financial statements included at Item 18. of this annual report. (b) See Note D.27. to our consolidated financial statements included at Item 18. of this annual report. (c)This line records the impact of the workdown of acquired inventories remeasured at fair value at the acquisition date, which in 2025 relates to the Blueprint Medicines acquisition (see Note D.1.). (d)For 2025, this line mainly comprises a €1,663 million impairment loss recognized on tolebrutinib, a drug candidate in the registration phase targeting multiple sclerosis, reflecting the reduced probability of approval arising from the negative PERSEUS phase 3 study results in Primary Progressive Multiple Sclerosis (PPMS) and recent exchanges with the FDA and EMA on Secondary Progressive Multiple Sclerosis (SPMS). For 2024, this line includes a net impairment charge of €248 million, mainly due to (i) recognition of impairment losses of €640 million against various research and development projects (including a €239 million loss resulting from the decision taken in February 2025 to discontinue a Phase 3 clinical study investigating a vaccine candidate to prevent invasive E.coli disease), partially offset by (ii) impairment loss reversals recognized in connection with the disposals of the ProXTen platform and Enjaymo, for €225 million and €167 million respectively. (e)Excludes (i) restructuring costs and (ii) other adjustments attributable to non-controlling interests. (f)Mainly joint ventures. 3/ Business net income (non-IFRS financial measure) Sanofi also presents “Business net income”, a non-IFRS financial measure that is not included in our primary financial statements. The IFRS measure most directly comparable to “Business net income” is Net income attributable to equity holders of Sanofi, which amounted to €7,813 million for 2025, versus €5,560 million for 2024, representing an increase of 40.5%. “Business net income” amounted to €9,555 million for 2025 versus €8,912 million for 2024, representing an increase of 7.2%. “Business net income” for 2025 represents 21.9% of our net sales, compared with 21.7% in 2024. SANOFI FORM 20-F 2025 63 PART I ITEM 5. Operating and Financial Review and Prospects The table below reconciles Net income attributable to equity holders of Sanofi to our “Business net income”: (€ million) 2025 2024 Net income attributable to equity holders of Sanofi (IFRS) 7,813 5,560 Net income from the discontinued Opella business(a) (2,874) (64) Amortization of intangible assets 1,776 1,749 Impairment of intangible assets(b) 2,241 248 Fair value remeasurement of contingent consideration(c) 118 127 Expenses arising from the impact of acquisitions on inventories 126 10 Restructuring costs and similar items 1,138 1,396 Other gains and losses, and litigation 255 470 Financial (income)/expenses relating to financial liabilities accounted for at amortized cost and subject to periodic remeasurement (d) (93) 291 Tax effects of the items listed above: (1,311) (883) •amortization and impairment of intangible assets (888) (359) •fair value remeasurement of contingent consideration (27) (25) •expenses arising from the impact of acquisitions on inventories (35) — •restructuring costs and similar items (252) (320) •other items (109) (179) Other tax effects 22 (81) Other items(e) 344 89 Business net income (non-IFRS) 9,555 8,912 Average number of shares outstanding (million) 1,220.4 1,251.4 Basic earnings per share (IFRS) (€) 6.40 4.44 Reconciling items per share (€)(f) 1.43 2.68 Business earnings per share (non-IFRS) (€) 7.83 7.12 (a)In 2025, this line includes €2.6 billion related to the net gain on the Opella divestment, recognized on the date of loss of control (refer to Note D.1.). (b) For 2025, this line mainly comprises a €1,663 million impairment loss recognized on tolebrutinib, a drug candidate in the registration phase targeting multiple sclerosis, reflecting the reduced probability of approval arising from the negative PERSEUS phase 3 study results and recent exchanges with the FDA and EMA. For 2024, this line includes a net impairment charge of €248 million, mainly due to (i) recognition of impairment losses of €640 million against various research and development projects (including a €239 million loss resulting from the decision taken in February 2025 to discontinue a Phase 3 clinical study investigating a vaccine candidate to prevent invasive E.coli disease), partially offset by (ii) impairment loss reversals recognized in connection with the disposals of the ProXTen platform and Enjaymo, for €225 million and €167 million respectively. (c)This line includes an impact attributable to non-controlling interests, related to a remeasurement of contingent consideration within a subsidiary of Sanofi: €14 million expense in 2025 and €31 million expense in 2024. (d)This line corresponds to the financial expense arising from remeasurement of the financial liability recognized in the balance sheet to reflect estimated future royalties on sales of Beyfortus in the US. (e)In 2025, this line includes the €310 million share of the losses of the associate OPAL JV Co (accounted for under the equity method since May 1, 2025, see Note D.1.) attributable to the equity holders of Sanofi; that amount includes the effects of the purchase price allocation, and of related fair value adjustments to the identifiable assets and liabilities (mainly intangible assets and inventories). This line also includes the share of profits/losses arising from the equity-accounted investment in EUROAPI, including an impairment loss taken against the equity interests based on the quoted market price: €2.27 as of December 31, 2025 and €2.88 as of December 31, 2024. (f)Corresponds to the reconciliation between basic earnings per share (IFRS) and business earnings per share (non-IFRS): sum total of reconciling items divided by the weighted average number of shares outstanding. We define “Business net income” as Net income attributable to equity holders of Sanofi determined under IFRS, excluding the following items: •net income from discontinued operations, including Opella; •amortization and impairment losses charged against intangible assets (other than software and other rights of an industrial or operational nature); •fair value remeasurements of contingent consideration relating to business combinations (IFRS 3), or to divestments of operations meeting the definition of a business; •expenses arising from the remeasurement of inventories following business combinations (IFRS 3) or acquisitions of groups of assets that do not constitute a business within the meaning of paragraph 2b of IFRS 3; •restructuring costs and similar items (presented within the line item Restructuring costs and similar items); •other gains and losses (including gains and losses on major divestments), presented within the line item Other gains and losses, and litigation; •other costs and provisions related to litigation (presented within the line item Other gains and losses, and litigation); •(income)/expenses related to financial liabilities accounted for at amortized cost and subject to periodic remeasurement in accordance with paragraph B5.4.6 of IFRS 9 (Financial Instruments); •tax effects related to the items listed above as well as effects of major tax disputes; 64 SANOFI FORM 20-F 2025 PART I ITEM 5. Operating and Financial Review and Prospects •the share of profits/losses from investments accounted for using the equity method, except for the share of profits/losses from investments accounted for using the equity method, to the extent that this relates (i) to joint ventures or (ii) to associates with which Sanofi has entered into R&D agreements and/or whose operations are managed as an integral part of Sanofi’s business activities; and •the portion attributable to non-controlling interests of the items listed above. We also report “Business earnings per share” (“Business EPS”), a non-IFRS financial measure we define as “Business net income” divided by the weighted average number of shares outstanding. “Business EPS” was €7.83 for 2025, compared with €7.12 for 2024 (up 10.0%), based on an average number of shares outstanding of 1,220.4 million for 2025 and 1,251.4 million for 2024. The most significant reconciling items between “Business net income” and Net income attributable to equity holders of Sanofi relate to (i) the purchase accounting effects of our acquisitions of groups of assets and business combinations, particularly the amortization and impairment of intangible assets (other than software and other rights of an industrial or operational nature); (ii) the impacts of restructuring actions or transactions regarded as non-recurring, where the amounts involved are particularly significant; (iii) remeasurements recognized through profit or loss in respect of (a) amounts receivable in respect of business divestments and accounted for at fair value, (b) liabilities arising from business combinations (IFRS 3) and accounted for at fair value, and (c) liabilities accounted for at amortized cost and subject to periodic remeasurement under IFRS 9; and (iv) net income from discontinued operations, including Opella. We believe that excluding those impacts enhances an investor’s understanding of our underlying economic performance, because it gives a better representation of our recurring operating performance. We believe that eliminating charges related to purchase accounting effects (particularly amortization and impairment of some intangible assets) enhances comparability of our ongoing operating performance relative to our peers. Those intangible assets (principally rights relating to research and development, technology platforms and commercialization of products) are accounted for in accordance with IAS 38 (Intangible Assets) and IFRS 3 (Business Combinations). We also believe that eliminating the other effects of business combinations (such as the incremental cost of sales arising from the workdown of acquired inventories remeasured at fair value in business combinations) gives a better understanding of our recurring operating performance. Eliminating restructuring costs and similar items enhances comparability with our peers because those costs are incurred in connection with reorganization and transformation of Sanofi's programs, integration or separation as part of material deals. We believe that eliminating the effects of transactions that we regard as non-recurring and that involve particularly significant amounts (such as major gains and losses on disposals, and costs and provisions associated with major litigation and other major non-recurring items) improves comparability from one period to the next. Finally, remeasurements recognized in profit or loss during the period in respect of (i) assets or liabilities accounted for at fair value and recognized in the balance sheet in connection with business acquisitions or divestments or (ii) liabilities accounted for at amortized cost and subject to periodic remeasurement, generally determined on the basis of revised sales forecasts, are not reflective of our operating performance. In addition, “Business net income” excludes net income from the Opella discontinued operation, the results of which have been presented separately in the consolidated income statement since October 2024. Under IFRS 5 (Non-Current Assets Held for Sale and Discontinued Operations), a discontinued operation is defined as a component of an entity that has been disposed of or is classified as held for sale, and represents a separate major line of business. With effect from October 2024, “Business net income” from continuing operations is used by management to measure Sanofi’s financial performance on an ongoing basis. We believe that providing a performance measure aligned with our management approach is useful for investors and analysts. We remind investors, however, that “Business net income” should not be considered in isolation from, or as a substitute for, Net income attributable to equity holders of Sanofi reported in accordance with IFRS. In addition, we strongly encourage investors and potential investors not to rely on any single financial measure but to review our financial statements, including the notes thereto, carefully and in their entirety. We compensate for the material limitations described above by using “Business net income” only to supplement our IFRS financial reporting and by ensuring that our disclosures provide sufficient information for a full understanding of all adjustments included in “Business net income.” Because our “Business net income” and “Business EPS” are not standardized measures, they may not be directly comparable with the non-IFRS financial measures of other companies using the same or similar non-IFRS financial measures. A.1.6. Presentation of net sales In the discussion below, we present our consolidated net sales for 2025 and 2024. We analyze our net sales by various categories including medicines, vaccines, business, and geographical region. In addition to reported net sales, we analyze non-IFRS financial measures designed to isolate the impact on our net sales of currency exchange rates and changes in the structure of our group. When we refer to changes in our net sales at constant exchange rates (CER), that means that we have excluded the effect of exchange rates by recalculating net sales for the relevant period using the exchange rates that were used for the previous period. SANOFI FORM 20-F 2025 65 PART I ITEM 5. Operating and Financial Review and Prospects A.1.7. Financial presentation of alliances We have entered into a number of alliances for the development, co-promotion and/or co-marketing of our products. The two principal alliances are with Regeneron Pharmaceuticals, Inc. for the development and commercialization of therapeutic antibodies including Dupixent and Kevzara, and with AstraZeneca for the development and commercialization of Beyfortus (nirsevimab) for RSV prevention. Specifically with respect to Regeneron, in 2014 and 2020, Sanofi and Regeneron amended the Investor Agreement entered into by the two companies in 2007. Under the terms of the amendments, Sanofi accepted various restrictions, including “standstill” provisions that contractually prohibit Sanofi from seeking to directly or indirectly exert control of Regeneron or acquiring more than 30% of Regeneron’s capital stock (consisting of the outstanding shares of common stock and the shares of Class A stock). This prohibition remains in place until the earlier of (i) the later of the fifth anniversaries of the expiration or earlier termination of the Zaltrap collaboration agreement with Regeneron (related to the development and commercialization of Zaltrap) or the collaboration agreement with Regeneron on monoclonal antibodies, each as amended or (ii) other specified events. For detailed information on the terms, financial arrangements, and accounting treatment of these alliances, see Note C “Principal alliances” to our consolidated financial statements included at Item 18. of this annual report. A.1.8. Impact of exchange rates We report our consolidated financial statements in euros. Because we earn a significant portion of our revenues in countries where the euro is not the local currency, our results of operations can be significantly affected by exchange rate movements between the euro and other currencies. We experience these effects even though certain of these countries do not account for a large portion of our net sales. In 2025, we earned 50.8% of our net sales in the United States. An increase in the value of the US dollar against the euro has a positive impact on both our revenues and our operating income. A decrease in the value of the US dollar against the euro has a negative impact on our revenues, which is not offset by an equal reduction in our costs and therefore negatively affects our operating income. A variation in the value of the US dollar has a particularly significant impact on our operating income, which is higher in the United States than elsewhere. For a description of arrangements entered into to manage operating foreign exchange risks as well as our hedging policy, see “Item 11. Quantitative and Qualitative Disclosures about Market Risk,” and “Item 3. Key Information — D. Risk Factors — Risks Related to Financial Markets — Fluctuations in currency exchange rates could adversely affect our results of operations and financial condition.” A.1.9. Divestments On April 30, 2025, Sanofi and CD&R closed the Opella Transaction following the signature of the share purchase agreement (SPA) on February 18, 2025. The Opella Transaction generated a net cash inflow of €10.4 billion, presented within the line item Net cash inflow from the Opella transaction in the statement of cash flows. For more information on the Opella Transaction, see "— A.1.1. 2025 Overview" and Note D.1.1.1. to our consolidated financial statements included at Item 18 of this annual report. On November 29, 2024, Sanofi entered into a definitive agreement with Recordati for the sale of Sanofi's global rights to Enjaymo and the transfer of specific employees. Under this agreement, Sanofi received an upfront payment of $825 million and will be eligible for milestone payments of up to $250 million based on sales. For further details about the divestments mentioned above, see Note D.1. to our consolidated financial statements included at Item 18. of this annual report. A.1.10. Acquisitions In the year ended December 31, 2025, Sanofi: •entered into an agreement to acquire Dynavax; and •completed the acquisitions of Vicebio, Blueprint, DR-0201 and Vigil. For further information about these acquisitions see “— A.1.1. 2025 Overview” and Note D.1. to our consolidated financial statements included at Item 18. of this annual report. In the year ended December 31, 2024, Sanofi completed the acquisition of Inhibrx, adding SAR447537 (formerly INBRX-101) to Sanofi’s rare disease pipeline. The impact of this acquisition, as reflected within the line item Acquisitions of consolidated undertakings and investments accounted for using the equity method in the consolidated statement of cash flows, is a net cash outflow of $2,035 million. For further information about the Inhibrx acquisition, see “Item 4. Information on the Company – A. History and development of the Company” and Note D.1. to our consolidated financial statements included at Item 18. of this annual report. 66 SANOFI FORM 20-F 2025 PART I ITEM 5. Operating and Financial Review and Prospects A.1.11. Critical accounting and reporting policies Our consolidated financial statements are affected by the accounting and reporting policies that we use. Certain of our accounting and reporting policies are critical to an understanding of our results of operations and financial condition, and in some cases the application of these critical policies can be significantly affected by the estimates, judgments and assumptions made by management during the preparation of our consolidated financial statements. The accounting and reporting policies that we have identified as critical to a full understanding of our results of operations and financial condition are the following: 1/ Revenue recognition Our policies with respect to revenue recognition are discussed in Note B.13. to our consolidated financial statements included at Item 18. of this annual report. Revenue arising from the sale of goods is presented in the income statement within Net sales. Net sales comprise revenue from sales of medicines, vaccines, and active ingredients, net of sales returns, of customer incentives and discounts, and of certain sales-based payments paid or payable to the healthcare authorities. In accordance with IFRS 15 (Revenue from Contracts with Customers), such revenue is recognized when Sanofi transfers control over the product to the customer. Control refers to the ability to direct the use of, and obtain substantially all of the remaining benefits from, the products. For the vast majority of contracts, revenue is recognized when the product is physically transferred, in accordance with the delivery and acceptance terms agreed with the customer. For contracts entered into by our vaccines business, transfer of control is usually determined by reference to the terms of release (immediate or deferred) and acceptance of batches of vaccine. As regards contracts with distributors, Sanofi does not recognize revenue when the product is physically transferred to the distributor in case of products sold on consignment, or if the distributor acts as an agent. In such cases, revenue is recognized when control is transferred to the end customer, and the distributor’s commission is presented within the line item Selling and general expenses in the income statement. We offer various types of price reductions on our products. In particular, products sold in the US are covered by various programs (such as Medicare and Medicaid) under which products are sold at a discount. Rebates are granted to healthcare authorities, and under contractual arrangements with certain customers. For more information on price reductions of our products, see “Item 4. Information on the Company — B. Business Overview — B.5.4. Pricing & Reimbursement.” Some wholesalers are entitled to chargeback incentives based on the selling price to the end customer, under specific contractual arrangements. Cash discounts may also be granted for prompt payment. The discounts, incentives and rebates described above are estimated on the basis of specific contractual arrangements with our customers or of specific terms of the relevant regulations and/or agreements applicable for transactions with healthcare authorities, and of assumptions about the attainment of sales targets. We also estimate the amount of sales returns, on the basis of contractual sales terms and reliable historical data. Discounts, incentives, rebates and sales returns are recognized in the period in which the underlying sales are recognized within Net Sales, as a reduction of gross sales. For additional details regarding the financial impact of discounts, incentives, rebates and sales returns, see Note D.23. to our consolidated financial statements included at Item 18. of this annual report. Revenues from non-Sanofi products, mainly comprising royalty income from license arrangements and sales of non-Sanofi products by our US-based entity VaxServe, are presented within Other revenues. This line item also includes revenues arising from the distribution of Eloctate and Alprolix under Sanofi’s agreements with Swedish Orphan Biovitrum AB (Sobi) and revenue received under agreements for Sanofi to provide manufacturing services to third parties. Other revenues is also used to recognize revenues generated from the manufacturing of Consumer Healthcare products on behalf of Opella entities. Until April 30, 2025, Opella entities were within the scope of discontinued operations (see Note B.7. to our consolidated financial statements included at Item 18. of this annual report). With effect from May 1, 2025, Opella entities are treated as related parties in accordance with IAS 24 (see Note D.6. to our consolidated financial statements included at Item 18. of this annual report). In addition, Other revenues includes revenues associated with Consumer Healthcare operations not transferred on the effective date of loss of control of Opella. These comprise primarily, but not exclusively, Consumer Healthcare activities that were not transferred on the effective date of loss of control of Opella, primarily (i) hospital sales of Opella products in China, the transfer of which will be finalized no earlier than 2028 after a transitional period required to complete the transfer plan agreed with Sanofi in the context of public tendering arrangements; (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). Finally, in the interests of consistency, Other revenues includes revenues associated with Consumer Healthcare operations that will not be transferred on the effective date of loss of control of Opella. For further discussion of the Other revenues line item, see “— A.1.4. Sources of revenues and expenses.” SANOFI FORM 20-F 2025 67 PART I ITEM 5. Operating and Financial Review and Prospects 2/ Business combinations As discussed in Note B.3. “Business combinations and transactions with non-controlling interests” to our consolidated financial statements included at Item 18. of this annual report, business combinations are accounted for by the acquisition method. The acquiree’s identifiable assets and liabilities that satisfy the recognition criteria of IFRS 3 (Business Combinations) are measured initially at their fair values as at the acquisition date, except for (i) non-current assets classified as held for sale, which are measured at fair value less costs to sell and (ii) assets and liabilities that fall within the scope of IAS 12 (Income Taxes) and IAS 19 (Employee Benefits). Business combinations completed on or after January 1, 2010 are accounted for in accordance with the revised IFRS 3 and IFRS 10 (Consolidated Financial Statements). In particular, contingent consideration payable to former owners agreed in a business combination, e.g. in the form of payments upon the achievement of certain R&D milestones, is recognized as a liability at fair value as of the acquisition date irrespective of the probability of payment. If the contingent consideration was originally recognized as a liability, subsequent adjustments to the liability are recognized in profit or loss (see Note D.18. to our consolidated financial statements included at Item 18. of this annual report). 3/ Impairment of goodwill and intangible assets As discussed in Note B.6. “Impairment of property, plant and equipment, intangible assets, and investments accounted for using the equity method” and in Note D.5. “Impairment of intangible assets and property, plant and equipment” to our consolidated financial statements included at Item 18. of this annual report, we test our intangible assets for impairment periodically or when there is any internal or external indication of impairment. Such indicators could include primarily but not exclusively (i) increased market competition resulting from (for example) the introduction of a competitor’s product; (ii) earlier than expected loss of exclusivity; (iii) increased pricing pressure; (iv) restrictions imposed by regulatory authorities on the manufacture or sale of a product; (v) delay in the projected launch of a product; (vi) different from expected clinical study results; (vii) higher than expected development costs or (viii) lower than expected economic performance. We test for impairment on the basis of the same objective criteria that were used for the initial valuation. Our initial valuation and ongoing tests are based on the relationship of the value of our projected future cash flows associated with the asset to either the purchase price of the asset (for its initial valuation) or the carrying amount of the asset (for ongoing tests for impairment). Significant underlying assumptions requiring the exercise of considerable judgement are applied in the future cash flow projections used to determine the recoverability of intangible assets, including primarily but not exclusively (i) therapeutic class market growth drivers; (ii) expected impacts from competing products (including but not exclusively generics and biosimilars); (iii) projected pricing and operating margin levels; (iv) likely changes in the regulatory, legal or tax environment; and (v) management’s estimates of terminal growth or attrition rates. The recoverable amounts of intangible assets related to research and development projects are determined based on future net cash flows, which reflect the development stage of the project and the associated probability of success of marketization of the compound. The projected cash flows are discounted to present value using a discount rate, which factors in the risks inherent in cash flow projections. Changes in facts and circumstances, assumptions and/or estimates may lead to future additional impairment losses or reversal of impairment previously recorded. Key assumptions relating to goodwill impairment are the perpetual growth rate, the post-tax discount rate, and operating margin. A sensitivity analysis to the key assumptions is disclosed in Note D.5. “Impairment of intangible assets and property, plant and equipment” to our consolidated financial statements included at Item 18. of this annual report. 4/ Pensions and post-retirement benefits As described in Note B.23. “Employee benefit obligations” to our consolidated financial statements included at Item 18. of this annual report, we recognize our pension and retirement benefit commitments as liabilities on the basis of an actuarial estimate of the rights vested in employees and retirees at the end of the reporting period, net of the fair value of plan assets held to meet those obligations. We prepare this estimate at least on an annual basis taking into account financial assumptions (such as discount rates) and demographic assumptions (such as life expectancy, retirement age, employee turnover, and the rate of salary increases). We recognize all actuarial gains and losses (including the impact of a change in discount rate) immediately through equity. Depending on the key assumptions used, the pension and post-retirement benefit expense could vary within a range of outcomes and have a material effect on reported earnings. A sensitivity analysis to these key assumptions is set forth in Note D.19.1. “Provisions for pensions and other benefits” to our consolidated financial statements included at Item 18. of this annual report. 68 SANOFI FORM 20-F 2025 PART I ITEM 5. Operating and Financial Review and Prospects 5/ Taxes As discussed in Note B.22. “Income tax expense” to our consolidated financial statements included at Item 18. of this annual report, we recognize deferred income taxes on tax loss carry-forwards and on temporary differences between the tax base and carrying amount of assets and liabilities. We calculate our deferred tax assets and liabilities using enacted tax rates applicable for the years during which we estimate that the temporary differences are expected to reverse. We do not recognize deferred tax assets when it is more likely than not that the deferred tax assets will not be realized. The recognition of deferred tax assets is determined on the basis of profit forecasts for each tax group, and of the tax consequences of the strategic opportunities available to Sanofi. The positions adopted by Sanofi in tax matters are based on its interpretation of tax laws and regulations. Some of those positions may be subject to uncertainty. In such cases, Sanofi assesses the amount of the tax liability on the basis of the following assumptions: that its position will be examined by one or more tax authorities on the basis of all relevant information; that a technical assessment is carried out with reference to legislation, case law, regulations, and established practice; and that each position is assessed individually (or collectively where appropriate), with no offset or aggregation between positions. Those assumptions are assessed on the basis of facts and circumstances existing at the end of the reporting period. When an uncertain tax liability is regarded as probable, it is measured on the basis of Sanofi’s best estimate and recognized as a liability; uncertain tax assets are not recognized. 6/ Provisions for risks Sanofi and its subsidiaries and affiliates may be involved in litigation, arbitration or other legal proceedings. These proceedings typically are related to product liability claims, intellectual property rights, compliance and trade practices, commercial claims, employment and wrongful discharge claims, tax assessment claims, waste disposal and pollution claims, and claims under warranties or indemnification arrangements relating to business divestitures. As discussed in Note B.12. “Provisions for risks” to our consolidated financial statements included at Item 18. of this annual report, we record a provision where we have a present obligation, whether legal or constructive, as a result of a past event; it is probable that an outflow of resources embodying economic benefits will be required to settle the obligation; and a reliable estimate can be made of the amount of the outflow of resources. We also disclose a contingent liability in circumstances where we are unable to make a reasonable estimate of the expected financial effect that will result from the ultimate resolution of the proceeding, or a cash outflow is not probable. For additional details regarding the financial impact of provisions for risks, see Notes D.19.3. “Other provisions” and D.22. “Legal and Arbitral Proceedings” to our consolidated financial statements included at Item 18. of this annual report. 7/ Provisions for restructuring costs Provisions for restructuring costs include collective redundancy or early retirement benefits, compensation for early termination of contracts, and rationalization costs relating to restructured sites. Refer to Note D.19.2. to our consolidated financial statements included at Item 18. of this annual report. Provisions are estimated on the basis of events and circumstances related to present obligations at the end of the reporting period and of past experience, and to the best of management’s knowledge at the date of preparation of the financial statements. The assessment of provisions can involve a series of complex judgments about future events and can rely heavily on estimates and assumptions. Given the inherent uncertainties related to these estimates and assumptions, the actual outflows resulting from the realization of those risks could differ from our estimates. SANOFI FORM 20-F 2025 69 PART I ITEM 5. Operating and Financial Review and Prospects A.2. Results of operations Year ended December 31, 2025 compared with year ended December 31, 2024 Consolidated income statements (€ million) 2025 As % of netsales 2024 As % of netsales Net sales 43,626 100.0% 41,081 100.0% Other revenues 3,090 7.1% 3,205 7.8% Cost of sales (13,049) -29.9% (13,205) -32.1% Gross profit 33,667 77.2% 31,081 75.7% Research and development expenses (7,842) -18.0% (7,394) -18.0% Selling and general expenses (9,543) -21.9% (9,183) -22.4% Other operating income 1,231 1,089 Other operating expenses (5,655) (4,382) Amortization of intangible assets (1,776) (1,749) Impairment of intangible assets (2,241) (248) Fair value remeasurement of contingent consideration (104) (96) Restructuring costs and similar items (1,138) (1,396) Other gains and losses, and litigation (255) (470) Operating income 6,344 14.5% 7,252 17.7% Financial expenses (563) (1,073) Financial income 394 519 Income before tax and investments accounted for using the equity method 6,175 14.2% 6,698 16.3% Income tax expense (1,043) (1,204) Share of profit/(loss) from investments accounted for using the equity method (155) 60 Net income from continuing operations 4,977 5,554 Net income from discontinued operations 2,874 64 Net income 7,851 18.0% 5,618 13.7% Net income attributable to non-controlling interests 38 58 Net income attributable to equity holders of Sanofi 7,813 17.9% 5,560 13.5% Average number of shares outstanding (million) 1,220.4 1,251.4 Average number of shares after dilution (million) 1,225.6 1,256.1 •Basic earnings per share from continuing operations (€) 4.05 4.40 •Basic earnings per share from discontinued operations (€) 2.35 0.04 Basic earnings per share (€) 6.40 4.44 •Diluted earnings per share from continuing operations (€) 4.03 4.39 •Diluted earnings per share from discontinued operations (€) 2.34 0.04 Diluted earnings per share (€) 6.37 4.43 70 SANOFI FORM 20-F 2025 PART I ITEM 5. Operating and Financial Review and Prospects A.2.1. Net sales Consolidated net sales for the year ended December 31, 2025 amounted to €43,626 million, 6.2% higher than in 2024 on a reported basis. Exchange rate fluctuations had a negative effect of 3.7 percentage points overall, due mainly to adverse trends in the US dollar against the euro. At constant exchange rates (CER), net sales rose by 9.9%, driven mainly by strong performances for Dupixent and ALTUVIIIO. Reconciliation of Net sales (IFRS) to Net sales at CER (non-IFRS) (€ million) 2025 2024 Change Net sales (IFRS) 43,626 41,081 +6.2% Effect of exchange rates (1,531) Net sales at constant exchange rates (non-IFRS) 45,157 41,081 +9.9% When we refer to changes in our net sales at constant exchange rates (CER), that means we have excluded the effect of exchange rates by recalculating net sales for the relevant period using the exchange rates that were used for the previous period, with the exception of countries treated as hyperinflationary economies under IAS 29 (i.e. Argentina and Turkey, see Note A.4. to our consolidated financial statements). 1/ Net sales by operating segment Our net sales comprise the net sales generated by our Biopharma segment. (€ million) 2025 2024 Change on a reported basis (IFRS) Change at constant exchange rates (non-IFRS) Biopharma segment 43,626 41,081 +6.2% +9.9% Total net sales 43,626 41,081 +6.2% +9.9% SANOFI FORM 20-F 2025 71 PART I ITEM 5. Operating and Financial Review and Prospects 2/ Net sales by medicine, vaccine and geography – 2025 compared with 2024 (€ million) Total sales Change (on a reported basis) Change (at CER) United States Change (at CER) Europe Change (at CER) Rest of the world Change (at CER) Immunology Dupixent 15,714 +20.2% +25.2% 11,538 +26.7% 1,957 +20.8% 2,219 +21.3% Kevzara 507 +19.6% +23.6% 321 +36.6% 127 +5.0% 59 +7.0% Rare diseases ALTUVIIIO (*) 1,160 +70.1% +77.6% 979 +66.5% — —% 181 +183.1% Fabrazyme 1,019 -2.7% +0.1% 508 -0.4% 263 +3.5% 248 -2.3% Nexviazyme / Nexviadyme (*) 790 +18.4% +21.4% 393 +13.6% 279 +38.8% 118 +15.2% Cerezyme 695 -6.3% -3.9% 178 -2.6% 232 -4.9% 285 -3.9% Alprolix 603 +2.6% +7.0% 454 +1.7% — —% 149 +26.6% Myozyme 519 -22.7% -21.0% 173 -23.1% 173 -33.5% 173 —% Cerdelga 335 +0.6% +3.0% 180 +1.1% 137 +7.0% 18 -5.3% Aldurazyme 305 +2.7% +5.1% 74 +8.3% 84 —% 147 +6.4% Ayvakit (*) 305 —% —% 267 —% 36 —% 2 —% Eloctate 275 -25.3% -22.3% 178 -21.6% — —% 97 -23.5% Cablivi (*) 271 +8.8% +12.0% 143 +9.6% 107 +15.1% 21 +15.0% Xenpozyme (*) 228 +51.0% +54.3% 95 +23.5% 89 +93.5% 44 +83.3% Qfitlia (*) 9 —% —% 9 —% — —% — —% Wayrilz (Rilzabrutinib) (*) 7 —% —% 7 —% — —% — —% Neurology Aubagio 238 -37.2% -35.4% 135 -24.1% 67 -55.9% 36 -10.0% Oncology Sarclisa (*) 588 +24.8% +28.5% 244 +27.5% 174 +29.9% 170 +28.5% Jevtana 263 -9.3% -5.9% 200 -3.3% 3 -57.1% 60 -8.7% Fasturtec 175 -4.4% -1.6% 111 -3.4% 50 +4.2% 14 -6.3% Other medicines Lantus 1,733 +6.4% +10.3% 808 +32.1% 297 -12.4% 628 +0.8% Toujeo 1,345 +9.6% +12.0% 240 +15.2% 500 +4.4% 605 +17.5% Plavix 910 -0.4% +3.1% 6 —% 88 -3.3% 816 +3.8% Lovenox 822 -16.3% -14.4% 11 +22.2% 455 -19.9% 356 -7.4% Praluent 526 +8.9% +9.3% — —% 426 +25.0% 100 -28.0% Rezurock (*) 490 +4.3% +8.7% 425 +4.2% 18 -35.7% 47 +194.1% Thymoglobulin 490 -0.4% +3.7% 307 +2.9% 41 +5.1% 142 +5.0% Aprovel 417 +0.2% +3.1% 4 +25.0% 71 -2.7% 342 +4.1% Multaq 314 +1.0% +5.1% 285 +6.8% 10 -9.1% 19 -9.1% Soliqua/iGlarLixi 282 +24.2% +28.2% 100 +40.0% 51 +6.3% 131 +29.8% Tzield (*) 63 +16.7% +22.2% 59 +19.2% 2 +100.0% 2 +100.0% Mozobil 32 -56.8% -54.1% 4 -58.3% 8 -79.5% 20 -8.7% Others 3,777 -13.5% -11.0% 336 -17.8% 1,133 -11.4% 2,308 -9.7% Industrial Sales 483 -7.6% -6.1% 1 —% 472 -7.7% 10 +400.0% Vaccines Polio / Pertussis / Hib Vaccines & Boosters 2,554 -6.8% -4.4% 632 -3.1% 450 -9.5% 1,472 -3.3% COVID-19 (*) and Influenza vaccines 2,314 -9.4% -5.8% 1,328 -1.9% 556 -13.1% 430 -7.9% RSV (Beyfortus) (*) 1,781 +5.6% +9.5% 723 -27.9% 601 +36.1% 457 +168.5% Meningitis, Travel and Endemics Vaccines 1,287 -2.2% +0.8% 720 +1.9% 212 +3.9% 355 -2.9% Biopharma 43,626 +6.2% +9.9% 22,176 +16.3% 9,169 +1.6% 12,281 +5.6% Of which launches (*) 5,721 +29.1% +34.0% 3,361 +20.4% 1,306 +38.3% 1,054 +99.6% 72 SANOFI FORM 20-F 2025 PART I ITEM 5. Operating and Financial Review and Prospects 3/ Net sales – Biopharma segment In 2025, net sales for the Biopharma segment (see “— A.1.5. Segment Information and Business net income” for detailed disclosures about our operating segment, and Note D.35. to our consolidated financial statements included at Item 18. of this annual report) amounted to €43,626 million, up 6.2% on a reported basis and 9.9% at CER. The year-on-year reported-basis increase of €2,545 million reflects adverse exchange rate effects amounting to €1,531 million, and the following principal effects at CER: •solid performances from Dupixent (net sales up €3,292 million, or 25.2 %) and ALTUVIIIO (net sales up €529 million); and •the launch of Ayvakit (net sales of €325 million). Comments on the performances of our major Biopharma segment products are provided below. New launches ALTUVIIIO (hemophilia A) posted net sales of €1,160 million in 2025, up 77.6% CER, with 84.4% generated in the US. Growth continued to be driven by patient switching from older, short half-life and extended half-life factor medicines, including Eloctate, and from non-factor treatments. Total hemophilia A franchise sales (ALTUVIIIO + Eloctate) amounted to €1,435 million (+42.6% CER), representing an increase in Sanofi’s market share of factor-based treatments as well as of the overall hemophilia A market. Nexviazyme/Nexviadyme (Pompe disease) sales were €790 million, up 21.4% year-on-year, driven by Europe (+38.8% CER), where the rise was explained by switches from Myozyme/Lumizyme in the eligible late-onset Pompe disease population and an increase in new patients. In the US, where sales reached €393 million, the majority of patients have now transitioned off Myozyme/Lumizyme. Total sales for the Pompe franchise (Nexviazyme/Nexviadyme + Myozyme/Lumizyme) were €1,309 million. Nexviazyme/Nexviadyme now account for 60.4 % of total Pompe franchise sales. Sarclisa (multiple myeloma) reported sales of €588 million, up 28.5% CER, driven by strong growth in all three regions. Sales reached €244 million in the US (+27.5% CER), €174 million in Europe (+29.9% CER), and €170 million in the Rest of the World region (+28.5% CER). This significant progress is being largely driven by increased use in a front-line combination treatment setting. Sales of Rezurock (chronic graft-versus-host disease) were €490 million in 2025, an increase of 8.7% CER, driven by continued growth in the US (€425 million, +4.2% CER), where the product is becoming the standard of care in the indicated setting, and by rapid uptake in launch countries, especially China. Globally, over 20,000 patients have been prescribed Rezurock (including patients in early access or managed access programs) since launch, key drivers being the product's real-world efficacy, tolerability and oral route of administration. Ayvakit (mastocytosis) sales were €305 million. Ayvakit has been consolidated by Sanofi since mid-July 2025 following the acquisition of Blueprint. Sales were split between the US (€267 million) and Europe (€36 million) with continued growth in the number of patients treated. Annual sales reached $725 million, slightly ahead of Blueprint's expectations from earlier in the year (estimated at $700-$720 million). Sanofi does not hold marketing rights in China but receives royalties on sales by CStone Pharmaceuticals CO., Ltd. Cablivi (acquired thrombotic thrombocytopenic purpura) reported 2025 sales of €271 million (+12.0% CER), including €143 million (+9.6% CER) in the US, driven by more patients being identified for treatment in the US and Europe and less use of the US access program. Xenpozyme (acid sphingomyelinase deficiency) achieved sales of €228 million in 2025, an increase of 54.3% CER, mainly driven by Europe where net sales rose by 93.5% CER. Sales of Tzield (delayed onset of type 1 diabetes) amounted to €63 million, of which €59 million was generated in the US (+19.2% CER). Patient screenings continued to increase, driving slight growth in the number of patients treated. Sales of Qfitlia (hemophilia A and B) totaled €9 million, all of which was generated in the US, following approval in March 2025. Sales of Wayrilz (immune thrombocytopenia) totaled €7 million, all of which was generated in the US, following approval in August 2025. Immunology Dupixent generated net sales of €15,714 million in 2025, up 20.2% on a reported basis and 25.2% at CER, driven by continuing strong demand in the product’s approved indications: atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, chronic obstructive pulmonary disease, and bullous pemphigoid. Dupixent net sales for 2025 by geography were €11,538 million (+26.7% CER) in the US, €1,957 million (+20.8% CER) in Europe, and €2,219 million (+21.3% CER) in the Rest of the World region. Other main medicines Lantus sales were €1,733 million, up 10.3% CER. US sales were €808 million, up 32.1% CER, benefiting from the unavailability of competing medicines. Customer demand is now expected to normalize in 2026. In Europe, net sales decreased by 12.4% CER; in the Rest of the World region, sales were up 0.8% CER, mainly due to the strategy of switching to Toujeo in China. Toujeo sales rose by 12.0% CER to €1,345 million, led by the Rest of the World region where net sales were up 17.5% CER at €605 million. Toujeo increased its market share, especially in basal insulins, led by China where the product’s market share now exceeds that of Lantus. Sales of Fabrazyme reached €1,019 million in 2025 (+0.1% CER), with a slight rise in the number of patients. SANOFI FORM 20-F 2025 73 PART I ITEM 5. Operating and Financial Review and Prospects Plavix sales stabilized, posting growth of 3.1% CER to €910 million, mainly reflecting volume growth in China due to inclusion in the volume-based procurement (VBP) program, partly offset by market share slowdown in the other countries within the Rest of the World region (which represents the majority of sales at €816 million). Lovenox sales were down 14.4 % CER at €822 million, reflecting impacts from increasing competition in Europe and the Rest of the World region. Cerezyme sales decreased by 3.9% CER to €695 million. Sales for the global Gaucher disease franchise (Cerezyme and Cerdelga) reached €1,030 million. In 2025, sales of Alprolix amounted to €603 million, up 7.0% CER, driven by the Rest of the World region (+26.6% CER) and the US (+1.7% CER), due to supply sales under the collaboration with Sobi. Net sales of Praluent for 2025 reached €526 million, up 9.3% CER, underpinned by Europe (+25.0%) but partially mitigated by a decrease in the Rest of the World region of 28.0%. Sales of Myozyme/Lumizyme decreased by 21.0% CER in 2025 to €519 million, reflecting patient switches to Nexviazyme/Nexviadyme as mentioned above. Thymoglobulin sales rose by 3.7% CER to €490 million, driven by the US (+2.9% CER) and the Rest of the World region (+5.0% CER). Cerdelga sales were €335 million, up 3.0%, reflecting growth in the number of patients. Eloctate posted sales of €275 million in 2025, down 22.3% CER, as patients switched to ALTUVIIIO. Sales of Aubagio were down 35.4% CER at €238 million, reflecting the loss of exclusivity in the US in March 2023 (-24.1% CER in 2025), followed by the loss of exclusivity in Europe in September 2023 (-55.9% CER in 2025). Individual sales reporting for Aubagio is anticipated to discontinue in 2026 with any remaining sales to be included in the “Others” category. Vaccines In 2025, Vaccines sales were €7,936, down 4.4% on a reported basis and 1.2% CER, reflecting lower sales of influenza vaccines. Sales of Polio/Pertussis/Hib Vaccines and Boosters reached €2,554 million, down 4.4% CER. Influenza, COVID-19 vaccines sales were €2,314 million, down 5.8% CER in a contracted market. Sales in Europe (-13.1% CER) were impacted by price reductions in Germany, while sales in the US (-1.9% CER) were impacted by soft vaccination rates. Beyfortus sales reached €1,781 million, up 9.5% CER. Sales in Europe of €601 million (+36.1% CER) and in the Rest of World region of €457 million (+168.5% CER) were driven by the geographical rollout of all-infant protection. Beyfortus now protects infants in more than 45 countries. Sales in the US were down 27.9% CER at €723 million due to a high base effect and existing inventory levels at the beginning of the season. Meningitis, Travel and Endemics Vaccines sales increased by 0.8% CER to €1,287 million. 4/ Net sales by geographical region The table below sets forth our net sales for 2025 and 2024 by geographical region: (€ million) 2025 2024 Change on a reported basis Change at constant exchange rates United States 22,176 19,986 +11.0% +16.3% Europe 9,169 9,027 +1.6% +1.6% Rest of the World 12,281 12,068 +1.8% +5.6% of which China 2,621 2,666 -1.7% +2.0% Total net sales 43,626 41,081 +6.2% +9.9% In 2025, net sales in the United States reached €22,176 million, up 11.0% on a reported basis and 16.3% CER, driven by exceptional performances from Dupixent (+26.7% CER at €11,538 million) and ALTUVIIIO (+66.5% CER at €979 million). In Europe, net sales rose by 1.6% on a reported basis and by the same rate at CER in 2025 to €9,169 million, led by Dupixent and Beyfortus with growth of 20.8% (€1,957 million) and 36.1% (€601 million), respectively. In the Rest of the World region, net sales for 2025 increased by 1.8% on a reported basis and by 5.6% CER to €12,281 million, due to strong performances from Dupixent (+21.3% CER at €2,219 million) and Beyfortus (+168.5% CER at €457 million). A.2.2. Other income statement items 1/ Other revenues Other revenues decreased by 3.6% to €3,090 million in 2025 (versus €3,205 million in 2024). The Other revenues line item includes VaxServe sales of non-Sanofi products, amounting to €1,780 million (versus €1,959 million in 2024). It also includes sales of Opella products in markets retained by Sanofi (€487 million); supply sales to Opella (€120 million); royalties (€146 million); and other services/manufacturing services (€557 million). 74 SANOFI FORM 20-F 2025 PART I ITEM 5. Operating and Financial Review and Prospects 2/ Gross profit Gross profit for 2025 amounted to €33,667 million compared with €31,081 million in 2024, an increase of 8.3%. Gross margin (the ratio of gross profit to net sales) increased, reaching 77.2% in 2025, versus 75.7% in 2024, due to improvements in Cost of sales. 3/ Research and development expenses R&D expenses amounted to €7,842 million in 2025, versus €7,394 million in 2024, an increase of 6.1%, and represented 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-on-year, driven by strategic prioritization of key therapeutic growth areas (in particular in 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. 4/ Selling and general expenses Selling and general expenses amounted to €9,543 million in 2025 (21.9% of net sales), versus €9,183 million in 2024 (22.4% of net sales), a 3.9% year-on-year increase. The overall increase reflects continued support for launches and newer medicines in Specialty Care and Vaccines. However, the ratio of selling and general expenses to net sales was 0.5% lower than in 2024, reflecting improved operational efficiency and leverage as Sanofi scales its commercial operations. This positive trend illustrates Sanofi's ability to drive revenue growth while maintaining disciplined cost management, with sales growing faster than the associated selling and general expenses. The improvement in the ratio reflects the benefits of commercial excellence initiatives, optimized resource allocation, and economies of scale achieved across key markets and therapeutic areas. 5/ Other operating income and expenses Other operating income amounted to €1,231 million in 2025 (versus €1,089 million in 2024), and other operating expenses to €5,655 million (versus €4,382 million in 2024). Other operating income includes (i) gains from asset divestments, amounting to €485 million in 2025 (versus €539 million in 2024); (ii) out-licensing income from Amvuttra, amounting to €475 million in 2025 (versus €186 million in 2024); and (iii) income from Sanofi’s pharmaceutical partners, amounting to €189 million in 2025 (including €149 million from Regeneron, see Note D.26. and Note C.1. to our consolidated financial statements included at Item 18. of this annual report), compared with €221 million in 2024 (including €166 million from Regeneron). Other operating expenses include €5,072 million of expenses related to Regeneron (see Note C.1. to our consolidated financial statements included at Item 18. of this annual report), compared with €3,955 million for 2024. Overall, this represented a net expense of €4,424 million in 2025, compared with a net expense of €3,293 million in 2024. (€ million) 2025 2024 Change Other operating income 1,231 1,089 142 Other operating expenses (5,655) (4,382) (1,273) Other operating income/(expenses), net (4,424) (3,293) (1,131) The change of €1,131 million mainly reflects an increase in the share of profits generated by the monoclonal antibody alliance with Regeneron under the collaboration agreement (see Note C.1. to our consolidated financial statements included at Item 18. of this annual report), the principal factor being increased sales of Dupixent. The net contribution of items related to Regeneron to this line item is as follows: (€ million) 2025 2024 Income & expense related to (profit)/loss sharing under the Monoclonal Antibody Alliance (5,455) (4,143) Additional share of profit paid by Regeneron towards development costs(a) 1,089 833 Reimbursement to Regeneron of selling expenses incurred (699) (637) Total: Monoclonal Antibody Alliance (5,065) (3,947) Other (mainly Zaltrap and Libtayo) 142 158 Other operating income/(expenses), net related to Regeneron Alliance (4,923) (3,789) of which amount presented in “Other operating income” 149 166 (a)As of December 31, 2025, the commitment received by Sanofi in respect of the additional profit share payable by Regeneron towards development costs amounted to €0.5 billion, compared with €1.6 billion as of December 31, 2024. 6/ Amortization of intangible assets Amortization charged against intangible assets amounted to €1,776 million in 2025, compared with €1,749 million in 2024. This increase was mainly driven by amortization of the Ayvakit intangible asset following the acquisition of Blueprint, partly offset by some intangible assets reaching the end of their amortization periods. SANOFI FORM 20-F 2025 75 PART I ITEM 5. Operating and Financial Review and Prospects 7/ Impairment of intangible assets, net of reversals In 2025, this line corresponds to the recognition of net impairment losses of €2,241 million in 2025, and mainly comprises a €1,663 million impairment loss recognized on tolebrutinib, a drug candidate in the registration phase targeting multiple sclerosis, reflecting the reduced probability of approval arising from the negative PERSEUS phase 3 study results and recent exchanges with the FDA and EMA. For 2024, this line includes a net impairment charge of €248 million, mainly due to (i) recognition of impairment losses of €640 million against various research and development projects (including a €239 million loss resulting from the decision taken in February 2025 to discontinue a Phase 3 clinical study investigating a vaccine candidate to prevent invasive E.coli disease), partially offset by (ii) impairment loss reversals recognized in connection with the disposals of the ProXTen platform and Enjaymo, for €225 million and €167million respectively. 8/ Fair value remeasurement of contingent consideration Fair value remeasurements of contingent consideration assets and liabilities (recognized on acquisitions or disposals of activities) represented a net expense of €104 million in 2025, versus a net expense of €96 million in 2024. 9/ Restructuring costs and similar items Restructuring costs and similar items represented a total charge of €1,138 million in 2025, versus a charge of €1,396 million in 2024, a decrease of €258 million. In 2025, this line item mainly comprised (i) costs related to the social plans announced during the year and (ii) transaction, integration and separation costs associated with significant acquisitions or disposals (€312 million), mainly related to the acquisition of Blueprint. In 2024, restructuring and similar costs mainly comprised the impacts of (i) the renewal of the Job Management and Career Paths (GEPP) program in France to cover the 2024-2026 period, including scope extensions in the job profiles affected by transformations and (ii) a voluntary redundancy program announced in 2024 in connection with the reorganization of R&D operations to make Sanofi a leader in immunology. 10/ Other gains and losses, and litigation Other gains and losses, and litigation for 2025 represented a charge of €255 million related to major litigation. For 2024, this line item represented a charge of €470 million, mainly comprising a provision recognized in respect of the litigation related to Plavix (clopidogrel) in the US state of Hawaii. 11/ Operating income Operating income amounted to €6,344 million in 2025, versus €7,252 million in 2024. The year-on-year decrease was mainly due to an increase in net impairment losses charged against intangible assets. 12/ Financial income and expenses Net financial expenses were €169 million in 2025, versus €554 million in 2024, a decrease of €385 million. The 2025 amount includes financial income of €93 million (€291 million expense in 2024) in respect of the liability recognized in the balance sheet for estimated future royalties on US sales of Beyfortus (see Notes C.2. and D.29. to our consolidated financial statements included at Item 18. of this annual report). The cost of our net debt (see the definition in “— B. Liquidity and Capital Resources” below and Note D.29. to our consolidated financial statements included at Item 18. of this annual report ) was €166 million in 2025, compared with €186 million in 2024. 13/ Income before tax and investments accounted for using the equity method Income before tax and investments accounted for using the equity method reached €6,175 million in 2025, versus €6,698 million in 2024. 14/ Income tax expense Income tax expense represented €1,043 million in 2025, versus €1,204 million in 2024, giving an effective tax rate (IFRS) based on consolidated net income of 16.9% in 2025, compared with 18.0% in 2024. The reduction in income tax expense was mainly due to tax effects arising from increases in impairment of intangible assets linked to research and development projects, including tax effects arising from the €1,663 million impairment loss charged against intangible assets related to the tolebrutinib research program. The effective tax rate based on business net income is a non-IFRS financial measure (see definition under “— A.1.5. Segment information — Business Net Income” above). It is calculated on the basis of business operating income, minus net financial expenses and before (i) the share of profit/loss from investments accounted for using the equity method and (ii) net income attributable to non-controlling interests. We believe the presentation of this measure, used by our management, is also useful for investors as it provides a means to analyze the effective cost of taxes on our profits excluding (i) the reconciling items described in section A.1.5. above and (ii) non-recurring or unusual tax effects. However, it should not be seen as a substitute for the effective tax rate based on our consolidated net income. When calculated on business net income, our effective tax rate (non-IFRS) was 19.9% in 2025, compared with 19.8% in 2024. The main factors in this year-on-year change were (i) the impact of the OECD Pillar Two model rules, which aim to ensure that large multinationals pay a minimum level of tax on the income arising in each jurisdiction where they operate; and (ii) updates to estimates of prior period tax liabilities following progress of reviews and closure of open issues with tax authorities in various jurisdictions. 76 SANOFI FORM 20-F 2025 PART I ITEM 5. Operating and Financial Review and Prospects The table below reconciles our effective tax rate based on consolidated net income to our effective tax rate based on business net income: (as a percentage) 2025 2024 Effective tax rate based on consolidated net income (IFRS) 16.9% 18.0% Tax effects: Amortization and impairment of intangible assets 1.2 (0.4) Restructuring costs and similar items 0.6 0.5 Other tax effects 1.2 1.7 Effective tax rate based on business net income (non-IFRS) 19.9% 19.8% 15/ Share of profit/(loss) from investments accounted for using the equity method The line item Share of profit/(loss) from investments accounted for using the equity method showed a net loss of €155 million in 2025, including a loss of €310 million on the equity-accounted investment in the associate OPAL JV Co (see Note D.6), compared with a net gain of €60 million for 2024. 16/ Net income from continuing operations Net income from continuing operations amounted to €4,977 million in 2025, compared with €5,554 million in 2024. 17/ Net income from discontinued operations Due to (i) the classification of Opella's assets and liabilities as held for sale since the announcement on October 21, 2024 of the opening of exclusive negotiations with CD&R for the transfer of those assets and liabilities and (ii) the assessment that Opella qualifies as a principal line of business within the meaning of IFRS 5, the net income or loss of Opella is presented in a separate line item, Net income from discontinued operations (see Notes D.1. and D.36. to our consolidated financial statements included at Item 18. of this annual report). In 2025, Net income from discontinued operations amounted to €2,874 million, reflecting the net income of Opella until the date of loss of control and also including a net gain of €2.6 billion resulting from the divestment of Opella as of the date of loss of control. In 2024, Net income from discontinued operations amounted to €64 million. 18/ Net income attributable to non-controlling interests Net income attributable to non-controlling interests was €38 million in 2025, versus €58 million in 2024. 19/ Net income attributable to equity holders of Sanofi Net income attributable to equity holders of Sanofi amounted to €7,813 million in 2025, compared with €5,560 million in 2024. Basic earnings per share for 2025 was €6.40 versus €4.44 for 2024, based on an average number of shares outstanding of 1,220.4 million in 2025 and 1,251.4 million in 2024. Diluted earnings per share for 2025 was €6.37 versus €4.43 for 2024, based on an average number of shares after dilution of 1,225.6 million in 2025 and 1,256.1 million in 2024. A.2.3. Segment results For the Biopharma segment, business operating income (as defined in Note D.35. to our consolidated financial statements included at Item 18. of this annual report) was €12,123 million in 2025, compared with €11,285 million in 2024 (an increase of 7.4%). It represented 27.8% of our net sales in 2025, compared with 27.5% in 2024. B. Liquidity and capital resources Our operations generate significant positive cash flows. We fund our day-to-day investments (with the exception of significant acquisitions) primarily with operating cash flow, and pay regular dividends on our shares. “Net debt” is a non-IFRS financial indicator which is reviewed by our management, and which we believe provides useful information to measure our overall liquidity and capital resources. We define “net debt” as (i) the sum total of long-term debt, short-term debt and current portion of long-term debt, and interest rate and currency derivatives used to manage debt, minus (ii) the sum total of cash and cash equivalents and interest rate and currency derivatives used to manage cash and cash equivalents. Lease liabilities are not included in net debt. As of December 31, 2025 our total debt was €18,702 million and our net debt was €11,008 million, compared with €16,137 million and €8,772 million, respectively, as of December 31, 2024. See reconciliation of total debt to net debt in "— B.2. Consolidated balance sheet and debt" below. In order to assess our financing risk, we also use the “gearing ratio," a non-IFRS financial measure (see table in section “— B.2. Consolidated balance sheet and debt” below). We define the gearing ratio as the ratio of net debt to total equity. As of December 31, 2025, our gearing ratio was 15.4%, compared with 11.3% as of December 31, 2024. Because our net debt and gearing ratio are not standardized measures, they may not be directly comparable with the non-IFRS financial measures of other companies using the same or similar non-IFRS financial measures. Despite the use of non-IFRS SANOFI FORM 20-F 2025 77 PART I ITEM 5. Operating and Financial Review and Prospects measures by management in setting goals and measuring performance, these are non-IFRS measures that have no standardized meaning prescribed by IFRS. B.1. Consolidated statement of cash flows Generally, factors that affect our earnings – for example, pricing, volume, costs and exchange rates – flow through to cash from operations. The most significant source of cash from operations is sales of our branded medicines and vaccines. Receipts of royalty payments also contribute to cash from operations. Summarized consolidated statements of cash flows (€ million)(a) 2025 2024 Net cash provided by/(used in) continuing operating activities 10,561 8,607 Net cash provided by/(used in) operating activities of the discontinued Opella business 189 474 Net cash provided by/(used in) operating activities 10,750 9,081 Net cash provided by/(used in) continuing investing activities (12,849) (4,298) Net cash provided by/(used in) investing activities of the discontinued Opella business (36) (109) Net cash inflow from the Opella transaction(b) 10,438 — Net cash provided by/(used in) investing activities (2,447) (4,407) Net cash provided by/(used in) continuing financing activities (8,159) (5,751) Net cash provided by/(used in) financing activities of the discontinued Opella business (48) (12) Net cash provided by/(used in) financing activities (8,207) (5,763) Impact of exchange rates on cash and cash equivalents (47) (13) Cash and cash equivalents reported as “Assets held for sale" as of December 31, 2024 167 (167) Net change in cash and cash equivalents 216 (1,269) Cash and cash equivalents, beginning of period 7,441 8,710 Cash and cash equivalents, end of period 7,657 7,441 (a)Cash flows of the Opella business are presented separately in accordance with IFRS 5 (Non-current Assets Held for sale and Discontinued Operations). (b)For 2025, this amount includes €(667) million in respect of cash and cash equivalents held by Opella as of April 30, 2025. As of December 31, 2024, cash and cash equivalents held by Opella amounted to €167 million and were reported in "Assets held for sale" in the balance sheet as of that date. Net cash provided by/used in continuing operating activities represented a net cash inflow of €10,561 million in 2025, compared with €8,607 million in 2024. The year-on-year increase was due mainly to a lower level of operating cash flow before changes in working capital (€8,766 million in 2025, versus €9,222 million in 2024), more than offset by a net increase of €1,795 million in the working capital requirement in 2025 (versus a net decrease of €615 million in 2024), including the change in the US rebate provisions (€1,330 million) following the decision to reduce the Lantus list price effective January 1, 2024. Net cash provided by/used in continuing investing activities represented a net cash outflow of €12,849 million in 2025, compared with a net outflow of €4,298 million in 2024. The principal cash outflow in 2025 was the €9,394 million arising from Acquisitions of consolidated undertakings and investments accounted for using the equity method, in particular Blueprint Medicines (€7,542 million) and Vicebio (€968 million); that compares with an outflow of €1,901 million in 2024 (mainly related to the acquisition of Inhibrx for $2,035 million). Acquisitions of property, plant and equipment and intangible assets amounted to €3,538 million, versus €3,195 million in 2024. There were €1,762 million of acquisitions of property, plant and equipment (versus €1,733 million in 2024), most of which related to industrial facilities. Acquisitions of intangible assets (€1,776 million, versus €1,462 million in 2024) mainly comprised contractual payments for intangible rights under license and collaboration agreements. Proceeds from disposals of property, plant and equipment, intangible assets and other non-current assets, net of tax amounted to €847 million in 2025 versus €1,461 million in 2024; the 2024 figure mainly comprised the sale of the Enjaymo global rights to Recordati for pre-tax proceeds of €768 million. Net cash provided by/used in continuing financing activities represented a net cash outflow of €8,159 million in 2025, compared with a net cash outflow of €5,751 million in 2024. The 2025 figure includes the redemption of €2.6 billion of bonds, and the issuance of new bonds for €1.5 billion, €1.5 billion and $3.0 billion respectively. Other movements mainly included (i) the dividend payout to our shareholders of €4,772 million (versus €4,704 million in 2024); and (ii) a cash outflow of €5,030 million on purchases of treasury shares (versus €302 million in 2024). The net change in cash and cash equivalents of continuing operations in 2025 was a decrease of €9 million, versus a decrease of €1,442 million in 2024. Net cash flows of the discontinued Opella business represented a net cash inflow of €105 million in 2025 versus a net cash inflow of €353 million in 2024. Net cash inflow from the Opella transaction represented a net cash inflow of €10,438 million in 2025. This amount includes €(667) million in respect of cash and cash equivalents held by Opella as of April 30, 2025. As of December 31, 2024, cash and cash equivalents held by Opella amounted to €167 million, and were reported in Assets held for sale in the balance sheet as of that date. (1)Above a cap of €500 million per transaction. (2)Non-IFRS financial measure, as defined in “— Segment Information — Business Net income” above. (3)Not exceeding a cap of €500 million per transaction. 78 SANOFI FORM 20-F 2025 PART I ITEM 5. Operating and Financial Review and Prospects The net change in cash and cash equivalents during 2025 was an increase of €216 million; this compares with a decrease of €1,269 million in 2024. “Free cash flow” (a non-IFRS measure) for the year ended December 31, 2025 was €8,089 million, an increase from the 2024 figure of €5,955 million. For details of the arrangements in place to manage our liquidity needs for current operations as of December 31, 2025, refer to Note 17.1.(b) to our consolidated financial statements, included at Item 18. of this annual report. “Free cash flow” is a non-IFRS financial indicator which is reviewed by our management, and which we believe provides useful information to measure the net cash generated from our operations that is available for strategic investments(1) (net of divestments(1)), for debt repayment, and for payments to shareholders. “Free cash flow” comprises cash flows generated from our continuing operations; it is calculated from our “Business net income”(2) after adding back (in the case of expenses and losses) or deducting (in the case of income and gains) the following items: depreciation, amortization and impairment, share of undistributed earnings from investments accounted for using the equity method, gains & losses on disposals, net change in provisions including pensions and other post-employment benefits, deferred taxes, share-based payment expense and other non-cash items. It also includes net changes in working capital, capital expenditures and other asset acquisitions(3) net of disposal proceeds(3), and payments related to restructuring and similar items. “Free cash flow” is not defined by IFRS, and is not a substitute for Net cash provided by operating activities as reported under IFRS. Management recognizes that the term “Free cash flow” may be interpreted differently by other companies and under different circumstances. The table below sets forth a reconciliation between Net cash provided by continuing operating activities and “Free cash flow”: (€ million) 2025 2024 Net cash provided by/(used in) operating activities (IFRS) 10,750 9,081 Net cash provided by/(used in) operating activities (IFRS) of the discontinued Opella business (189) (474) Acquisitions of property, plant and equipment and software (1,858) (1,808) Acquisitions of intangible assets, equity interests and other non-current financial assets(a) (1,761) (1,434) Proceeds from disposals of property, plant and equipment, intangible assets and other non-current assets, net of tax(a) 744 805 Repayments of lease liabilities(b) (333) (282) Other items(c) 736 67 Free cash flow (non-IFRS) 8,089 5,955 (a)Free cash flow includes investments and divestments not exceeding a cap of €500 million per transaction. (b)Cash outflows relating to repayments of the principal portion of lease liabilities (IFRS 16) are included in free cash flow. (c)This line item includes cash outflows from major litigation not included in "Free cash flow," in particular the Plavix litigation in Hawaii in 2025. B.2. Consolidated balance sheet and debt Total assets were €126,805 million as of December 31, 2025, compared with €132,798 million as of December 31, 2024, a decrease of €5,993 million. Total equity was €71,710 million as of December 31, 2025, versus €77,857 million as of December 31, 2024. The year-on-year net change reflects the following principal factors: •increases: our net income for 2025 (€7,851 million); and •decreases: the dividend paid to our shareholders in respect of the 2024 financial year (€4,772 million), repurchases of our own shares (€5,015 million) and negative currency translation differences (€4,867 million). “Total debt” was €18,702 million as of December 31, 2025, compared with €16,137 million as of December 31, 2024. "Net debt" was €11,008 million as of December 31, 2025, compared with €8,772 million as of December 31, 2024. The increase in 2025 mainly reflects cash outflows related to (i) acquisitions exceeding a cap of €500 million per transaction (cash outflow of €10,986 million) and (ii) the dividend payout to our shareholders (cash outflow of €4,772 million), less the €8,089 million of free cash flow generated from continuing operations in the year (see reconciliation with Net cash provided by/(used in)operating activities in section B.1. above) and the €10,443 million cash inflow from the Opella transaction. “Net debt” is a non-IFRS financial measure which is reviewed by our management, and which we believe provides useful information to measure our overall liquidity and capital resources. We define “net debt” as (i) the sum total of long-term debt, short-term debt and current portion of long-term debt and interest rate and currency derivatives used to manage debt, minus (ii) the sum total of cash and cash equivalents and interest rate and currency derivatives used to manage cash and cash equivalents. SANOFI FORM 20-F 2025 79 PART I ITEM 5. Operating and Financial Review and Prospects (€ million) 2025 2024 Long-term debt 14,248 11,791 Short-term debt and current portion of long-term debt 4,342 4,209 Interest rate and currency derivatives used to manage debt 112 137 Total debt 18,702 16,137 Cash and cash equivalents (7,657) (7,441) Interest rate and currency derivatives used to manage cash and cash equivalents (37) 76 Net debt(a) (non- IFRS) 11,008 8,772 Total equity 71,710 77,857 Gearing ratio (non-IFRS) 15.4% 11.3% (a)Net debt does not include lease liabilities, which amounted to €1,739 million as of December 31, 2025 and €1,906 million as of December 31, 2024. “Net debt” is a non-IFRS financial measure used by management and investors to measure Sanofi’s overall net indebtedness. To assess our financing risk, we use the “gearing ratio”, a non-IFRS financial measure. This ratio (which we define as the ratio of net debt to total equity) increased from 11.3% as of December 31, 2024 to 15.4% as of December 31, 2025. Analyses of debt as of December 31, 2025 and December 31, 2024 by type, maturity, interest rate and currency, are provided in Note D.17.1. to our consolidated financial statements, included at Item 18. of this annual report. We expect that the future cash flows generated by our operating activities will be sufficient to repay our debt. The financing arrangements in place as of December 31, 2025 at the Sanofi parent company level are not subject to covenants regarding financial ratios and do not contain any clauses linking fees to Sanofi’s credit rating. As of December 31, 2025, we held 11.96 million of our own shares, recorded as a deduction from equity and representing 0.98% of our share capital. As of December 31, 2024, we were holding 9.5 million of our own shares, recorded as a deduction from equity and representing 0.75% of our share capital. Goodwill and Other intangible assets (€67,561 million in total) increased by €1,548 million, driven mainly by new acquisitions (DR-0201, Blueprint, Vigil and Vicebio), partly offset by amortization and impairment charged during the period and movements in currency translation differences. Investments accounted for using the equity method (€3,259 million) increased by €2,943 million, mainly reflecting the acquisition of 48.2% in the associate OPAL JV Co. Other non-current assets amounted to €4,364 million, a year-on-year increase of €611 million. Net deferred tax assets amounted to €6,942 million as of December 31, 2025, versus €5,801 million as of December 31, 2024, a year-on-year increase of €1,141 million. The year-on-year increase mainly reflects (i) an increase in tax losses available for carry- forward; and (ii) an increase in deferred tax assets arising on the spread tax deduction of R&D expenses in the US. Non-current provisions and other non-current liabilities (€6,703 million) showed a decrease of €1,393 million, mainly due to funding of pension obligations and various litigation settlements. Liabilities related to business combinations and to non-controlling interests were €56 million lower year-on-year, at €585 million. Assets held for sale (€208 million) and Liabilities related to assets held for sale (€54 million) were both substantially lower than in 2024, when these line items included the assets and liabilities of the held-for-sale Opella business, over which Sanofi lost control in 2025 (see Note D.8. to our consolidated financial statements included at Item 18. of this annual report). B.3. Liquidity We expect that our existing cash resources and cash from operations will be sufficient to finance our foreseeable working capital requirements, in both the short term (i.e. the 12 months following the year ended December 31, 2025) and the long term (i.e. beyond such additional 12-month period). As of December 31, 2025, we held cash and cash equivalents amounting to €7,657 million (see Note D.13. to our consolidated financial statements included at Item 18. of this annual report). As of December 31, 2025, €490 million of our cash and cash equivalents were held by captive insurance and reinsurance companies in accordance with insurance regulations. We run the risk of delayed payments or even non-payment by our customers, who consist principally of wholesalers, distributors, pharmacies, hospitals, clinics and government agencies (see “Item 3. Key information — D. Risk Factors — 2. Risks Relating to Our Business — We are subject to the risk of non-payment by our customers”). Deteriorating credit and economic conditions and other factors in some countries have resulted in, and may continue to result in, an increase in the average length of time taken to collect our accounts receivable in these countries. Should these factors continue, it may require us to re-evaluate the collectability of these receivables in future periods. We carefully monitor sovereign debt issues and economic conditions and evaluate accounts receivable in these countries for potential collection risks. We have been conducting an active recovery policy, adapted to each country and including intense communication with customers, negotiations of payment plans, charging of interest for late payments, and legal action. Over our business as a whole, the amount of trade receivables overdue by more than 12 months (which primarily consists of amounts due from public sector bodies) increased from €44 million as of December 31, 2024 to €52 million as of December 31, 2025 (see Note D.10. to our consolidated financial statements included at Item 18. of this annual report). 80 SANOFI FORM 20-F 2025 PART I ITEM 5. Operating and Financial Review and Prospects As of December 31, 2025, we had no commitments for capital expenditures that we consider to be material to our consolidated financial position. Undrawn confirmed credit facilities amounted to a total of €8,000 million at December 31, 2025. For a discussion of our treasury policies, see “Item 11. Quantitative and Qualitative Disclosures about Market Risk.” We expect that cash from our operations will be sufficient to repay our debt. For a discussion of our liquidity risks, see “Item 11. Quantitative and Qualitative Disclosures about Market Risk.” B.4. Off balance sheet arrangements/Contractual obligations and other commercial commitments We have various contractual obligations and other commercial commitments arising from our operations. Our contractual obligations and our other commercial commitments as of December 31, 2025 are shown in Notes D.3., D.17., D.18., and D.21. to our consolidated financial statements included at Item 18. of this annual report. Note D.21. to our consolidated financial statements included at Item 18. of this annual report discloses details of commitments under our principal research and development collaboration agreements. For a description of the principal contingencies arising from certain business divestitures, refer to Note D.22. to our 2025 consolidated financial statements included at Item 18. of this annual report. Off balance sheet commitments relating to Sanofi’s operating activities, not including as of December 31, 2025 the commitments of the held-for-sale Opella operation, comprise the following (for Opella off balance sheet commitments, refer to Note D.36.): December 31, 2025 Payments due by period (€ million) Total Less than1 year 1 to3 years 3 to5 years More than5 years Future contractual cash flows relating to debt and debt hedging instruments(a) 20,431 4,653 5,805 5,412 4,561 Principal payments related to lease liabilities(b) 1,929 303 532 409 685 Other lease obligations (with a term of less than 12 months, low value asset leases and lease contracts committed but not yet commenced)(c) 476 26 23 44 383 Irrevocable purchase commitments(d) •Given 5,098 1,999 1,414 810 875 •Received (2,356) (411) (595) (540) (810) Research & development license agreements •Commitments related to R&D and other commitments 221 196 16 4 5 •Potential milestone payments(e) 5,341 373 1,413 1,027 2,528 Obligations relating to business combinations(f) 476 127 — — 349 Estimated benefit payments on unfunded pensions and post employment benefits(g) 985 63 109 116 697 Total contractual obligations and other commitments 32,601 7,329 8,717 7,282 9,273 Undrawn general-purpose credit facilities 8,000 — 4,000 4,000 — (a)See Note D.17.1. to our consolidated financial statements, included at Item 18. of this annual report. (b)See Note D.17.2. to our consolidated financial statements, included at Item 18. of this annual report. (c)See Note D.21.1. to our consolidated financial statements, included at Item 18. of this annual report. (d)These comprise irrevocable commitments to suppliers of (i) property, plant and equipment, net of down payments (see Note D.3. to our consolidated financial statements included at Item 18. of this annual report) and (ii) goods and services. (e)This line includes all milestone payments on projects regarded as reasonably possible, i.e. on projects in the development phase. (f)See Note D.18. to our consolidated financial statements included at Item 18. of this annual report. (g)See Note D.19.1. to our consolidated financial statements included at Item 18. of this annual report. The table above does not include ongoing annual employer’s contributions to plan assets, estimated at €29 million for 2025. We may have payments due to our current or former research and development partners under collaboration agreements. These agreements typically cover multiple products, and give us the option to participate in development on a product-by- product basis. When we exercise our option with respect to a product, we pay our collaboration partner a fee and receive intellectual property rights to the product in exchange. We are also generally required to fund some or all of the development costs for the products that we select, and to make payments to our partners when those products reach development milestones. We have entered into collaboration agreements under which we have rights to acquire products or technology from third parties through the acquisition of shares, loans, license agreements, joint development, co-marketing and other contractual arrangements. In addition to upfront payments on signature of the agreement, our contracts frequently require us to make payments contingent upon the completion of development milestones by our alliance partner or upon the granting of approvals or licenses. Because of the uncertain nature of development work, it is impossible to predict (i) whether Sanofi will exercise further options for products, or (ii) whether the expected milestones will be achieved, or (iii) the number of compounds that will reach the relevant milestones. It is therefore impossible to estimate the maximum aggregate amount that Sanofi will actually pay in the future under existing collaboration agreements. Given the nature of its business, it is highly unlikely that Sanofi will exercise all options for all products or that all milestones will be achieved. SANOFI FORM 20-F 2025 81 PART I ITEM 5. Operating and Financial Review and Prospects The main collaboration agreements relating to development projects are described in Note D.21.1. to our consolidated financial statements included at Item 18. of this annual report. Milestone payments relating to development projects under these agreements included in the table above exclude projects still in the research phase (€13.9 billion in 2025, €14.4 billion in 2024) and payments contingent upon the attainment of sales targets once a product is on the market (€15.6 billion in 2025, €15.2 billion in 2024). C. Research and development, patents and licenses, etc. Our research and development teams utilize our deep expertise to contribute to the growth of our business. As of December 31, 2025, we had 9,274 employees engaged in research and development activities. In the years ended December 31, 2024 and 2025 we spent €7,394 million and €7,842 million, respectively, on research and development. For a discussion of our research and development activities, see “Item 4. Information on the Company — B. Business Overview” and section “— A. Operating Results” above. D. Trend information For a discussion of trends, see “Item 4. Information on the Company — Business Overview” and sections “— A. Operating Results” and “— Liquidity and Capital Resources” above. E. Critical accounting estimates For a discussion of our critical accounting estimates, see Note A.3. to our consolidated financial statements included in Item 18. of this annual report. 82 SANOFI FORM 20-F 2025 PART I ITEM 6. Directors, Senior Management and Employees