Sarilumab

First quarter 2026 revenues increased 19% to $3.6 billion versus first quarter 2025 Dupixent ® global net sales (recorded by Sanofi) increased 33% to $4.9 billion EYLEA HD ® U.S. net sales increased 52% to $468 million; total EYLEA HD and EYLEA ® U.S. net sales decreased 10% to $941 million GAAP EPS of $6.75, including $0.82 negative impact from IPR&D; non-GAAP EPS (a) of $9.47, including $0.80 negative impact from IPR&D EYLEA HD approved by FDA as first and only injectable anti-VEGF with dosing intervals up to 5 months for wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) Dupixent approved by FDA and European Commission (EC) for young children with chronic spontaneous urticaria (CSU); also approved by FDA as first and only medicine for allergic fungal rhinosinusitis (AFRS) Otarmeni ™ (lunsotogene parvec) approved by FDA as first and only gene therapy for genetic hearing loss; Regeneron to provide Otarmeni for free in U.S. New $3.0 billion share repurchase program authorized TARRYTOWN, N.Y., April 29, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) today announced financial results for the first quarter of 2026 and provided a business update. "In the first quarter of this year, we were able to achieve strong double-digit growth on both the top and bottom line while continuing to invest significant resources in our portfolio of nearly 50 product candidates in clinical development," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. "Additionally, we recently entered into an agreement with the U.S. government that aims to make progress toward lowering drug prices for American patients by promoting more balanced pricing with other wealthy nations — an approach for which Regeneron has long advocated." Financial Highlights ($ in millions, except per share data) Q1 2026 Q1 2025 % Change Total revenues $ 3,605 $ 3,029 19 % GAAP net income $ 727 $ 809 (10 %) GAAP net income per share - diluted $ 6.75 $ 7.27 (7 %) Non-GAAP net income (a) $ 1,040 $ 928 12 % Non-GAAP net income per share - diluted (a) $ 9.47 $ 8.22 15 % "Regeneron delivered strong first quarter 2026 financial results, achieving total revenue and non‑GAAP net income per share growth of 19% and 15%, respectively," said Christopher Fenimore, Executive Vice President, Finance and Chief Financial Officer of Regeneron. "In addition to driving commercial execution, we remain focused on our balanced approach to capital allocation—investing in our internal innovation engine, returning capital to shareholders through dividends and share repurchases, expanding our R&D and manufacturing footprint to support long-term growth, and preserving financial flexibility to pursue strategic business development opportunities." Business Highlights Key Pipeline Progress Regeneron has nearly 50 product candidates in clinical development, including a number of marketed products for which it is investigating additional indications. Updates from the clinical pipeline include: Dupixent (dupilumab) In April 2026, the U.S. Food and Drug Administration (FDA) and European Commission approved Dupixent for the treatment of CSU in children aged 2 to 11 years who remain symptomatic despite antihistamine treatment. This expands the previous approvals in the United States and European Union (EU) for CSU in adults and adolescents aged 12 years and older. In March 2026, the Ministry of Health, Labour and Welfare (MHLW) in Japan approved Dupixent for the treatment of adults with moderate-to-severe bullous pemphigoid (BP). Dupixent was previously approved for the treatment of BP in the United States and a regulatory application is under review in the EU. In February 2026, the FDA approved Dupixent as the first and only medicine for the treatment of adults and children aged 6 years and older with AFRS. EYLEA HD (aflibercept) 8 mg In April 2026, the FDA approved the extension of dosing intervals for EYLEA HD up to every 20 weeks (5 months) for patients with wAMD and DME following one year of successful response based on visual and anatomic outcomes. This further extends the widest range of dosing intervals of any approved injectable anti-VEGF product. The Company resubmitted its application seeking FDA approval for filling of the EYLEA HD pre-filled syringe (PFS) at Catalent Indiana, where the FDA has recently conducted a site re-inspection. In addition, the FDA did not act by the April 2026 PDUFA date on the Company's regulatory application for a second contract manufacturer for the PFS; therefore, this application remains pending. The Company and both third-party filling manufacturers are working closely with the FDA to resolve all outstanding issues, and the Company anticipates a regulatory decision on one or both applications during the second quarter of 2026. Otarmeni (lunsotogene parvec) In April 2026, the FDA granted accelerated approval for Otarmeni (lunsotogene parvec, formerly known as DB-OTO), the first gene therapy approved under the FDA Commissioner’s National Priority Voucher program. Otarmeni is an adeno-associated virus vector-based gene therapy indicated for the treatment of pediatric and adult patients with severe-to-profound hearing loss associated with variants in the OTOF gene. Otarmeni is the first and only in vivo gene therapy for genetic hearing loss and will be made available by Regeneron for free in the United States. Fianlimab (LAG-3 antibody) The Company remains on track to report results from the Phase 3 study of fianlimab in combination with cemiplimab versus pembrolizumab in first-line metastatic melanoma in the second quarter of 2026. Following the first interim analysis, an Independent Data Monitoring Committee recommended that the Phase 3 study of fianlimab in combination with cemiplimab in adjuvant melanoma continue as planned. A second interim analysis as well as the study's final analysis, if necessary, are anticipated in the second half of 2026. Regeneron remains blinded to these data. The Company determined that Phase 2 data evaluating fianlimab in combination with cemiplimab in first-line advanced non-small cell lung cancer (NSCLC) did not support advancement to Phase 3 development. Other Programs The Company submitted a New Drug Application (NDA) for cemdisiran (C5 siRNA therapy) in myasthenia gravis, and utilized an FDA Rare Pediatric Disease Priority Review Voucher. NDA acceptance is anticipated in the second quarter of 2026 with an FDA decision expected in the fourth quarter of 2026. In February 2026, the FDA accepted for priority review the Biologics License Application (BLA) for garetosmab (an Activin A antibody) for the treatment of adults with fibrodysplasia ossificans progressiva (FOP), which has a target action date in August 2026. A regulatory application is also under review in the EU. A Phase 3 study for REGN7508, an antibody to Factor XI (catalytic domain), was initiated in cancer-associated venous thromboembolism. In addition, a three-arm, placebo-controlled Phase 3 study was initiated to evaluate REGN7508 and REGN9933, an antibody to Factor XI (A2 domain), individually, in stroke prevention in patients with atrial fibrillation who are not candidates for daily oral anticoagulation therapy. Initiation of additional Phase 3 studies for these Factor XI antibodies is planned for later this year. A Phase 3 study was initiated for mibavademab, an agonist antibody to leptin receptor (LEPR), in monogenic obesity. Corporate Updates In April 2026, the Company announced agreements with the U.S. government pursuant to which the Company will provide certain of its products to the Medicaid program at or below prices benchmarked against a defined group of other developed countries (Most-Favored-Nation Pricing), price certain future medicines in the United States at or below Most-Favored-Nation Pricing, offer Praluent ® for direct patient purchase, and continue its large investment in domestic R&D and manufacturing capacity. Furthermore, Regeneron will not be subject to future U.S. government pricing mandates and will receive tariff relief for three years. In March 2026, the Company entered into a strategic collaboration with TriNetX to receive access to TriNetX’s current and future de-identified health data from approximately 300 million individuals, sourced directly from its global network of health system partners. This collaboration will enable expansion of the Company’s genomic and proteomic Electronic Health Record (EHR)-linked database. In April 2026, the Company entered into a collaboration with Telix Pharmaceuticals Limited to jointly develop and commercialize next generation radiopharmaceutical therapies. In February 2026, the Company announced the renewal of Regeneron’s title sponsorship of the Regeneron Science Talent Search (STS), the United States’ oldest and most prestigious science and mathematics competition for high school seniors. The Company is also increasing its commitment for the next 10 years, pledging an additional $150 million, and bringing its 20-year investment in STS to $250 million. In February 2026, the Company reached resolution of its patent infringement litigation related to the Samsung EYLEA (aflibercept) Injection 2 mg biosimilar product. This settlement precludes Samsung from launching its biosimilar product in the United States until January 2027. All intellectual property-related litigation with Samsung in the United States has been dismissed. First Quarter 2026 Financial Results Revenues ($ in millions) Q1 2026 Q1 2025 % Change Net product sales: EYLEA HD - U.S. $ 468 $ 307 52 % EYLEA - U.S. 473 736 (36 %) Total EYLEA HD and EYLEA - U.S. 941 1,043 (10 %) Libtayo ® - U.S. 286 192 49 % Libtayo - ROW* 152 93 63 % Total Libtayo - Global 438 285 54 % Praluent - U.S. 67 57 18 % Evkeeza ® - U.S. 46 31 48 % Lynozyfic ® - Global 11 — ** Other products - Global 32 — ** Total net product sales 1,535 1,416 8 % Collaboration revenue: Sanofi 1,605 1,183 36 % Bayer 287 344 (17 %) Other 7 4 75 % Other revenue 171 82 109 % Total revenues $ 3,605 $ 3,029 19 % * Rest of world (ROW) ** Percentage not meaningful Net product sales of EYLEA HD increased in the first quarter of 2026, compared to the first quarter of 2025, due to higher sales volumes driven by increased demand, partly offset by a lower net selling price. In addition, EYLEA HD net product sales were negatively impacted by lower wholesaler inventory levels at the end of the first quarter of 2026 compared to the end of the fourth quarter of 2025. EYLEA HD net product sales decreased 7% on a sequential basis; however, physician unit demand increased sequentially by 10%. Net product sales of EYLEA in the first quarter of 2026, compared to the first quarter of 2025, were negatively impacted by (i) lower sales volumes as a result of continued competitive pressures and the continued transition of patients to EYLEA HD, and (ii) a lower net selling price. Sanofi collaboration revenue increased in the first quarter of 2026, compared to the first quarter of 2025, due to an increase in the Company's share of profits from the commercialization of antibodies, which were $1.451 billion and $1.018 billion in the first quarter of 2026 and 2025, respectively. The change in the Company's share of profits from commercialization of antibodies was driven by higher profits primarily associated with an increase in Dupixent sales. Refer to Table 4 for a summary of collaboration revenue. Operating Expenses GAAP % Change Non-GAAP (a) % Change ($ in millions) Q1 2026 Q1 2025 Q1 2026 Q1 2025 Research and development (R&D) $ 1,544 $ 1,327 16 % $ 1,408 $ 1,186 19 % Acquired in-process research and development (IPR&D) $ 102 $ 12 ** * * n/a Selling, general, and administrative (SG&A) $ 648 $ 633 2 % $ 560 $ 537 4 % Cost of goods sold (COGS) $ 373 $ 266 40 % $ 209 $ 217 (4 %) Gross margin on net product sales (b) 76% 81% 86% 85% Cost of collaboration and contract manufacturing (COCM) (c) $ 296 $ 199 49 % $ 281 $ 199 41 % * GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been recorded ** Percentage not meaningful GAAP and non-GAAP R&D expenses increased in the first quarter of 2026, compared to the first quarter of 2025, driven by the advancement of the Company's late-stage clinical pipeline, including programs in hematology-oncology, complement-mediated diseases, and anticoagulation. Acquired IPR&D expenses for the first quarter of 2026 primarily related to the premium on equity securities purchased, as well as development milestone and up-front payments, in connection with collaboration and licensing agreements. GAAP and non-GAAP SG&A expenses increased in the first quarter of 2026, compared to the first quarter of 2025, primarily due to an increase in commercialization-related expenses for EYLEA HD and Libtayo and higher headcount and headcount-related costs, partly offset by lower charitable contributions to an independent non-profit patient assistance organization. GAAP gross margin on net product sales decreased in the first quarter of 2026, compared to the first quarter of 2025, primarily due to unabsorbed manufacturing costs and higher inventory write-offs and reserves as a result of a temporary interruption of bulk manufacturing production at the Company's facility in Limerick, Ireland, due to unanticipated facility repairs that commenced during the first quarter of 2026. The Company resumed initial production at the facility in the second quarter of 2026; however, GAAP gross margin will continue to be negatively impacted until production returns to normal levels, which is expected by the end of the second quarter of 2026. The interruption has not impacted, nor is it expected to impact, the availability of any of the Company's products. Other Financial Information GAAP other income (expense), net decreased in the first quarter of 2026, compared to the first quarter of 2025, primarily due to lower net gains on marketable and other securities. In the first quarter of 2026, the Company's GAAP effective tax rate (ETR) was 12.5%, compared to 10.6% in the first quarter of 2025. The GAAP ETR increased in the first quarter of 2026, compared to the first quarter of 2025, primarily due to lower tax benefits from cross-border tax laws and federal tax credits for research activities. In the first quarter of 2026, the non-GAAP ETR was 13.9%, compared to 11.6% in the first quarter of 2025. A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press release. Capital Allocation During the first quarter of 2026, the Company repurchased $803 million of its common stock. As of March 31, 2026, $688 million remained available for share repurchases under the Company's share repurchase programs. In April 2026, the Company's board of directors authorized a new share repurchase program to repurchase up to an additional $3.0 billion of the Company's common stock. Repurchases may be made from time to time at management's discretion through a variety of methods. The program has no time limit and can be discontinued at any time. In April 2026, the Company's board of directors declared a cash dividend of $0.94 per share on the Company's common stock and Class A stock, payable on June 4, 2026 to shareholders of record as of May 20, 2026. 2026 Financial Guidance* The Company's full year 2026 financial guidance consists of the following components: 2026 Guidance Prior Updated GAAP R&D $6.450–$6.680 billion Unchanged Non-GAAP R&D (a) $5.900–$6.100 billion Unchanged GAAP SG&A $2.860–$3.040 billion Unchanged Non-GAAP SG&A (a) $2.500–$2.650 billion Unchanged GAAP gross margin on net product sales 79%–80% 77%–78% Non-GAAP gross margin on net product sales (a) 83%–84% Unchanged GAAP COCM $940 million–$1.020 billion $955 million–$1.035 billion Non-GAAP COCM (a) $940 million–$1.020 billion Unchanged Capital expenditures $1.100–$1.300 billion $1.100–$1.200 billion GAAP effective tax rate 12%–14% Unchanged Non-GAAP effective tax rate (a) 13%–15% Unchanged * The Company's 2026 financial guidance does not assume the completion of any business development transactions not completed as of the date of this press release A reconciliation of full year 2026 GAAP to non-GAAP financial guidance is included below: Projected Range ($ in millions) Low High GAAP R&D $ 6,450 $ 6,680 Stock-based compensation expense (550 ) (580 ) Non-GAAP R&D (a) $ 5,900 $ 6,100 GAAP SG&A $ 2,860 $ 3,040 Stock-based compensation expense (350 ) (370 ) Other* (10 ) (20 ) Non-GAAP SG&A (a) $ 2,500 $ 2,650 GAAP gross margin on net product sales 77% 78% Stock-based compensation expense 1% 1% Other** 5% 5% Non-GAAP gross margin on net product sales (a) 83% 84% GAAP COCM $ 955 $ 1,035 Temporary manufacturing interruption-related costs (15 ) (15 ) Non-GAAP COCM (a) $ 940 $ 1,020 GAAP ETR 12% 14% Income tax effect of GAAP to non-GAAP reconciling items 1% 1% Income tax expense: Shortfall from stock-based compensation (<1% ) (<1% ) Non-GAAP ETR (a) 13% 15% * Includes legal settlements and other costs ** Includes intangible asset amortization and temporary manufacturing interruption-related costs (a) This press release uses non-GAAP R&D, non-GAAP SG&A, non-GAAP COGS, non-GAAP gross margin on net product sales, non-GAAP COCM, non-GAAP other income (expense), net, non-GAAP ETR, non-GAAP net income, non-GAAP net income per share, and free cash flow, which are financial measures that are not calculated in accordance with U.S. Generally Accepted Accounting Principles (GAAP). These non-GAAP financial measures are computed by excluding certain non-cash and/or other items from the related GAAP financial measure. The Company also includes a non-GAAP adjustment for the estimated income tax effect of reconciling items. A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press release. The Company makes such adjustments for items the Company does not view as useful in evaluating its operating performance. For example, adjustments may be made for items that fluctuate from period to period based on factors that are not within the Company's control (such as the Company's stock price on the dates share-based grants are issued or changes in the fair value of the Company's investments in equity securities) or items that are not associated with normal, recurring operations (such as acquisition and integration costs). Management uses these non-GAAP measures for planning, budgeting, forecasting, assessing historical performance, and making financial and operational decisions, and also provides forecasts to investors on this basis. With respect to free cash flow, the Company believes that this non-GAAP measure provides a further measure of the Company's ability to generate cash flows from its operations. Additionally, the non-GAAP measures presented are intended to provide investors with an enhanced understanding of the financial performance of the Company's core business operations. However, there are limitations in the use of these and other non-GAAP financial measures as they exclude certain expenses that are recurring in nature. Furthermore, the Company's non-GAAP financial measures may not be comparable with non-GAAP information provided by other companies. Any non-GAAP financial measure presented by the Company should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with GAAP. (b) Gross margin on net product sales represents gross profit expressed as a percentage of total net product sales recorded by the Company. Gross profit is calculated as net product sales less cost of goods sold. (c) Corresponding reimbursements from collaborators and others for manufacturing product is recorded within revenues. Conference Call Information Regeneron will host a conference call and simultaneous webcast to discuss its first quarter 2026 financial and operating results on Wednesday, April 29, 2026, at 8:30 AM Eastern Time. Participants may access the conference call live via webcast, or register in advance and participate via telephone, on the "Investors and Media" page of Regeneron's website at Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay and transcript of the conference call and webcast will be archived on the Company's website for at least 30 days. About Regeneron Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, Regeneron's unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in Regeneron's laboratories. Regeneron's medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using its proprietary technologies, such as VelociSuite ® , which produces optimized fully human antibodies and new classes of bispecific antibodies. Regeneron is shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center ®  and pioneering genetic medicine platforms, enabling Regeneron to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit or follow Regeneron on LinkedIn, Instagram, Facebook, or X. Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, competing products and product candidates (including biosimilar products) that may be superior to, or more cost effective than, products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products") and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates"); uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties or other factors beyond Regeneron's control on the commercial success of Regeneron's Products and Regeneron's Product Candidates; the nature, timing, and possible success and therapeutic applications of Regeneron's Products and Regeneron's Product Candidates and research and clinical programs now underway or planned, including without limitation EYLEA HD ® (aflibercept) Injection 8 mg, EYLEA ® (aflibercept) Injection, Dupixent ® (dupilumab), Libtayo ® (cemiplimab), Praluent ® (alirocumab), Kevzara ® (sarilumab), Evkeeza ® (evinacumab), Veopoz ® (pozelimab), Ordspono ™ (odronextamab), Lynozyfic ® (linvoseltamab), Otarmeni ™ (lunsotogene parvec), other clinical programs discussed in this press release, Regeneron's and its collaborators' earlier-stage programs, and the use of human genetics in Regeneron's research programs; the likelihood and timing of achieving any of the anticipated milestones described in this press release; safety issues resulting from the administration of Regeneron's Products and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron's Product Candidates in clinical trials; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, including those listed above and/or otherwise discussed in this press release; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; the ability of Regeneron’s collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron's Product Candidates; the availability and extent of reimbursement or copay assistance for Regeneron’s Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes to drug pricing regulations and requirements and Regeneron's drug pricing strategy, including in connection with Regeneron's April 2026 agreements with the U.S. government discussed in this press release; other changes in laws, regulations, and policies affecting the healthcare industry; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance, including GAAP and non-GAAP R&D, GAAP and non-GAAP SG&A, GAAP and non-GAAP gross margin on net product sales, GAAP and non-GAAP COCM, capital expenditures, and GAAP and non-GAAP ETR; the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the fiscal year ended December 31, 2025 and its Form 10-Q for the quarterly period ended March 31, 2026. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website ( ) and its LinkedIn page ( ). Non-GAAP Financial Measures This press release and/or the financial results attached to this press release include amounts that are considered "non-GAAP financial measures" under SEC rules. As required, Regeneron has provided reconciliations of such non-GAAP financial measures. Contact Information: Ryan Crowe Christina Chan Investor Relations Corporate Affairs 914-847-8790 914-847-8827 ryan.crowe@regeneron.com christina.chan@regeneron.com TABLE 1 REGENERON PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (In millions) March 31, December 31, 2026 2025 Assets: Cash and marketable securities $ 18,539.7 $ 18,865.8 Accounts receivable, net 5,731.0 5,741.1 Inventories 3,103.6 3,200.8 Property, plant, and equipment, net 5,266.1 5,120.4 Intangible assets, net 1,286.9 1,257.4 Deferred tax assets 4,190.9 4,077.2 Other assets 2,750.6 2,296.0 Total assets $ 40,868.8 $ 40,558.7 Liabilities and stockholders' equity: Accounts payable, accrued expenses, and other liabilities $ 5,877.7 $ 5,834.2 Finance lease liabilities 720.0 720.0 Deferred revenue 861.3 761.7 Long-term debt 1,986.2 1,985.9 Stockholders' equity 31,423.6 31,256.9 Total liabilities and stockholders' equity $ 40,868.8 $ 40,558.7 TABLE 2 REGENERON PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (In millions, except per share data) Three Months Ended March 31, 2026 2025 Revenues: Net product sales $ 1,534.5 $ 1,415.6 Collaboration revenue 1,899.7 1,531.2 Other revenue 171.2 81.9 3,605.4 3,028.7 Expenses: Research and development 1,543.5 1,327.4 Acquired in-process research and development 101.9 12.3 Selling, general, and administrative 647.7 633.0 Cost of goods sold 373.4 265.5 Cost of collaboration and contract manufacturing 296.0 198.8 2,962.5 2,437.0 Income from operations 642.9 591.7 Other income (expense): Other income (expense), net 201.2 322.0 Interest expense (12.9 ) (8.7 ) 188.3 313.3 Income before income taxes 831.2 905.0 Income tax expense 104.0 96.3 Net income $ 727.2 $ 808.7 Net income per share - basic $ 6.99 $ 7.58 Net income per share - diluted $ 6.75 $ 7.27 Weighted average shares outstanding - basic 104.0 106.7 Weighted average shares outstanding - diluted 107.7 111.2 TABLE 3 REGENERON PHARMACEUTICALS, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited) (In millions, except per share data) Three Months Ended March 31, 2026 2025 GAAP R&D $ 1,543.5 $ 1,327.4 Stock-based compensation expense (135.1 ) (141.0 ) Non-GAAP R&D $ 1,408.4 $ 1,186.4 GAAP SG&A $ 647.7 $ 633.0 Stock-based compensation expense (89.2 ) (95.2 ) Litigation settlements 5.0 — Other costs (3.2 ) (0.8 ) Non-GAAP SG&A $ 560.3 $ 537.0 GAAP COGS $ 373.4 $ 265.5 Stock-based compensation expense (33.1 ) (19.5 ) Intangible asset amortization expense (39.4 ) (28.7 ) Temporary manufacturing interruption-related costs (91.9 ) — Non-GAAP COGS $ 209.0 $ 217.3 GAAP COCM $ 296.0 $ 198.8 Temporary manufacturing interruption-related costs (14.8 ) — Non-GAAP COCM $ 281.2 $ 198.8 GAAP other income (expense), net $ 188.3 $ 313.3 Gains on marketable and other securities, net (25.0 ) (139.9 ) Non-GAAP other income (expense), net $ 163.3 $ 173.4 GAAP net income $ 727.2 $ 808.7 Total of GAAP to non-GAAP reconciling items above 376.7 145.3 Income tax effect of GAAP to non-GAAP reconciling items (67.5 ) (25.6 ) Income tax expense: Shortfall from stock-based compensation 3.1 — Non-GAAP net income $ 1,039.5 $ 928.4 Non-GAAP net income per share - basic $ 10.00 $ 8.70 Non-GAAP net income per share - diluted $ 9.47 $ 8.22 Shares used in calculating: Non-GAAP net income per share - basic 104.0 106.7 Non-GAAP net income per share - diluted 109.8 113.0 RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited) (continued) Three Months Ended March 31, 2026 2025 Effective tax rate reconciliation: GAAP ETR 12.5 % 10.6 % Income tax effect of GAAP to non-GAAP reconciling items 1.5 % 1.0 % Income tax expense: Shortfall from stock-based compensation (0.1 %) — % Non-GAAP ETR 13.9 % 11.6 % Gross margin on net product sales reconciliation: GAAP gross margin on net product sales 76 % 81 % Stock-based compensation expense 2 % 2 % Intangible asset amortization expense 2 % 2 % Temporary manufacturing interruption-related costs 6 % — % Non-GAAP gross margin on net product sales 86 % 85 % Free cash flow reconciliation: Net cash provided by operating activities $ 1,078.9 $ 1,045.1 Capital expenditures (230.6 ) (229.3 ) Free cash flow $ 848.3 $ 815.8 TABLE 4 REGENERON PHARMACEUTICALS, INC. COLLABORATION REVENUE (Unaudited) (In millions) Three Months Ended March 31, 2026 2025 Sanofi collaboration revenue: Regeneron's share of profits in connection with commercialization of antibodies $ 1,450.8 $ 1,018.2 Reimbursement for manufacturing of commercial supplies 154.3 165.0 Total Sanofi collaboration revenue 1,605.1 1,183.2 Bayer collaboration revenue: Regeneron's share of profits in connection with commercialization of EYLEA 8 mg and EYLEA outside the United States 240.0 317.3 Reimbursement for manufacturing of commercial supplies 47.3 26.6 Total Bayer collaboration revenue 287.3 343.9 Other collaboration revenue 7.3 4.1 Total collaboration revenue $ 1,899.7 $ 1,531.2 TABLE 5 REGENERON PHARMACEUTICALS, INC. NET PRODUCT SALES OF REGENERON-DISCOVERED PRODUCTS (Unaudited) (In millions) Three Months Ended March 31, 2026 2025 % Change U.S. ROW Total U.S. ROW Total (Total Sales) Dupixent (a) $ 3,558.4 $ 1,321.7 $ 4,880.1 $ 2,629.4 $ 1,036.2 $ 3,665.6 33 % EYLEA HD (b) $ 468.4 $ 332.5 $ 800.9 $ 306.8 $ 146.4 $ 453.2 77 % EYLEA (b) $ 473.1 $ 396.2 $ 869.3 $ 736.0 $ 711.4 $ 1,447.4 (40 %) Total EYLEA HD and EYLEA $ 941.5 $ 728.7 $ 1,670.2 $ 1,042.8 $ 857.8 $ 1,900.6 (12 %) Libtayo (c) $ 286.1 $ 152.1 $ 438.2 $ 192.5 $ 92.6 $ 285.1 54 % Praluent (d) $ 66.6 $ 179.1 $ 245.7 $ 56.8 $ 136.5 $ 193.3 27 % Kevzara (a) $ 100.5 $ 44.3 $ 144.8 $ 72.8 $ 43.6 $ 116.4 24 % Lynozyfic $ 10.7 $ 0.5 $ 11.2 $ — $ — $ — * Other products (e) $ 77.1 $ 29.3 $ 106.4 $ 31.1 $ 23.5 $ 54.6 95 % Note: The table above includes net product sales of Regeneron-discovered products. Such net product sales are recorded by the Company or others, as further described in the footnotes below. * Percentage not meaningful (a) Sanofi records global net product sales of Dupixent and Kevzara, and the Company records its share of profits in connection with global sales of such products within Collaboration revenue (b) The Company records net product sales of EYLEA HD and EYLEA in the United States, and Bayer records net product sales outside the United States. The Company records its share of profits in connection with sales outside the United States within Collaboration revenue. (c) The Company records global net product sales of Libtayo and pays Sanofi a royalty on such sales (d) The Company records net product sales of Praluent in the United States. Sanofi records net product sales of Praluent outside the United States and pays the Company a royalty on such sales, which is recorded within Other revenue. (e) Included in this line item are products which are sold by the Company and others. Refer to "First Quarter 2026 Financial Results" section above for a listing of net product sales recorded by the Company. Not included in this line item are net product sales of ARCALYST ® , which are recorded by Kiniksa.

Approval for children aged 2 to 11 years with CSU who remain symptomatic despite H1 antihistamine treatment based primarily on data from the LIBERTY-CUPID clinical trial program CSU is a chronic skin disease that causes itch and hives that can be debilitating for young children, especially for those whose disease remains uncontrolled CSU marks the fifth disease driven in part by type 2 inflammation for which Dupixent is approved in children younger than 12 years of age TARRYTOWN, N.Y. and PARIS , April 22, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of children aged 2 to 11 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 antihistamine (H1AH) treatment. This expands the previous approval for Dupixent in adults and adolescents aged 12 years and older with CSU. “With this approval, Dupixent has become the first biologic medicine in the U.S. for young children suffering from uncontrolled chronic spontaneous urticaria, an unpredictable skin disease that impacts quality of life during these children’s most formative years,” said George D. Yancopoulos , M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron , and a principal inventor of Dupixent. “Dupixent is now approved for nine different allergy-related conditions, from asthma to atopic dermatitis, and this is the fifth of these indications now extended to young children. The FDA’s authorization reinforces our medicine’s well-established safety profile and potential to transform outcomes for chronic diseases driven in part by type 2 inflammation impacting some of the most vulnerable populations. As the most widely used innovative branded antibody medicine, Dupixent has the potential to change yet another treatment paradigm.” The approval is based primarily on data from the LIBERTY-CUPID clinical trial program. This includes extrapolation of efficacy and safety data from two Phase 3 trials (Study A and Study C) in certain adults and adolescents aged 12 years and older with CSU complemented with pharmacokinetics data from the single-arm, CUPIDKids Phase 3 trial in children aged 2 to 11 years with CSU. In Study A and Study C, Dupixent significantly reduced itch severity and urticaria activity (a composite of itch and hives) compared to placebo at week 24. In adults and adolescents, Dupixent also increased the likelihood of well-controlled disease or complete response compared to placebo at week 24. Study B provided additional safety data and evaluated Dupixent in patients aged 12 years and older who were inadequate responders or intolerant to anti-IgE therapy and symptomatic despite antihistamine use. Safety in children aged 2 to 11 years with CSU was supported by data from pediatric patients in other indications. The safety results from all four CSU trials were generally consistent with the known safety profile of Dupixent in its approved dermatological indications. In Study A, Study B and Study C, the most common adverse reaction (≥2%) in the U.S. Prescribing Information more frequently observed in patients on Dupixent compared to placebo was injection site reactions. No new adverse reactions were identified in children aged 2 to 11 years with CSU treated with Dupixent. “Children with uncontrolled chronic spontaneous urticaria continue to experience the unpredictable appearance of debilitating itch and hives,” said Alyssa Johnsen, M.D., Ph.D., Global Therapeutic Area Head, Immunology Development at Sanofi. “Until now, these patients had to rely on limited treatment options that didn’t address potential critical mediators of chronic spontaneous urticaria. Dupixent is the first biologic approved for patients as young as 2 years of age, offering a targeted approach that inhibits IL-4 and IL-13 signaling, two key and central drivers of the type 2 inflammation that contributes to this disease. Today’s approval underscores our ongoing commitment to advancing therapies for young patients with significant unmet needs.” In addition to the U.S. , Dupixent is approved for CSU in certain children aged 2 to 11 years in the EU and other countries around the world. About CSUCSU is a chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and recurring itch. CSU is typically treated with H1AH, medicines that target H1 receptors on cells to control symptoms of itch and urticaria. However, the disease remains uncontrolled despite H1AH treatment in more than 14,000 children in the U.S. aged 2 to 11 years living with CSU, some of whom are left with limited alternative treatment options. These individuals continue to experience symptoms that can be debilitating and significantly impact their quality of life. About the Dupixent CSU Phase 3 Trial ProgramThe LIBERTY-CUPID Phase 3 program evaluating Dupixent for CSU in children aged 2 to 11 years consists of CUPIDKids, Study A, Study B and Study C. CUPIDKids was a single arm clinical trial that assessed the safety, efficacy and pharmacokinetics of Dupixent in children aged 2 to 11 years with CSU who remained symptomatic despite the use of antihistamines. During the 24-week treatment period, Dupixent was administered at 200 mg every two or four weeks or 300 mg every four weeks, with or without an initial loading dose, based on age and weight. The primary endpoint measured the serum concentration of Dupixent over time, including Ctrough (lowest concentration before the next dose) at week 12 and week 24. Study A and Study C were replicate, double-blind, placebo-controlled clinical trials that assessed Dupixent as an add-on therapy to standard-of-care antihistamines compared to antihistamines alone in patients aged 6 years and older who remained symptomatic despite the use of antihistamines and were naïve to anti-IgE therapy. Study B was conducted in patients aged 12 years and older who were symptomatic despite use of antihistamines and were inadequate responders or intolerant to anti-IgE therapy. During the 24-week treatment period in all three trials, all patients received an initial loading dose followed by either 300 mg Dupixent every two weeks or, for pediatric patients weighing 30 kg to <60 kg, 200 mg every two weeks. In both trials, endpoints assessed at week 24 included: Change from baseline in itch (measured by the weekly itch severity score [ISS7], 0-21 scale), the primary endpoint. Change from baseline in itch and hives (weekly urticaria activity score [UAS7], 0-42 scale), the key secondary endpoint. Proportion of patients achieving well-controlled disease status (UAS7 ≤6). Proportion of patients with complete response (UAS7=0). About DupixentDupixent is an injection administered under the skin (subcutaneous injection) at different injection sites. In children aged 2 to 11 years with CSU who remain symptomatic despite H1 antihistamine treatment, Dupixent is administered based on age and weight. In children aged 2 to 5 years, Dupixent is administered at 200 mg every four weeks for patients weighing ≥5 kg to <15 kg and 300 mg every four weeks for ≥15 kg to <30 kg, without an initial loading dose. In children aged 6 to 17 years, Dupixent is administered at 300 mg every four weeks for ≥15 kg to <30 kg, 200 mg every two weeks for ≥30 kg to <60 kg and 300 mg every two weeks for ≥60 kg, after an initial loading dose. Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home after training by a healthcare professional. In children aged 2 to 11 years, Dupixent should be administered by a caregiver if given at home. Dupixent, which was invented using Regeneron’s proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are two of the key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. Regeneron and Sanofi are committed to helping patients in the U.S. who are prescribed Dupixent gain access to the medicine and receive the support they may need with the DUPIXENT MyWay® program. For more information, please call 1-844-DUPIXENT (1-844-387-4936) or visit www.DUPIXENT.com. Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis, CSU, chronic obstructive pulmonary disease (COPD), bullous pemphigoid (BP) and allergic fungal rhinosinusitis (AFRS) in different age populations. More than 1,400,000 patients are being treated with Dupixent globally.1 About Regeneron 's VelocImmune Technology Regeneron 's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron 's co-Founder, Board co-Chair, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved fully human monoclonal antibodies. This includes Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz® (pozelimab-bbfg). In addition, REGEN-COV® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024. Dupilumab Development ProgramDupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 12,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Regeneron and Sanofi are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including chronic pruritus of unknown origin and lichen simplex chronicus. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. U.S. INDICATIONS DUPIXENT is a prescription medicine used: to treat adults and children 6 months of age and older with moderate-to-severe eczema (atopic dermatitis or AD) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in children with AD under 6 months of age. with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in adults and children 6 years of age and older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. It is not known if DUPIXENT is safe and effective in children with asthma under 6 years of age. with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults and children 12 years of age and older whose disease is not controlled. It is not known if DUPIXENT is safe and effective in children with CRSwNP under 12 years of age. to treat adults and children 1 year of age and older with eosinophilic esophagitis (EoE), who weigh at least 33 pounds (15 kg). It is not known if DUPIXENT is safe and effective in children with EoE under 1 year of age, or who weigh less than 33 pounds (15 kg). to treat adults with prurigo nodularis (PN). It is not known if DUPIXENT is safe and effective in children with PN under 18 years of age. with other medicines for the maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and a high number of blood eosinophils (a type of white blood cell that may contribute to your COPD). DUPIXENT is used to reduce the number of flare-ups (the worsening of your COPD symptoms for several days) and can improve your breathing. It is not known if DUPIXENT is safe and effective in children with COPD under 18 years of age. to treat adults and children 2 years of age and older with chronic spontaneous urticaria (CSU) who continue to have hives that are not controlled with H1 antihistamine treatment. It is not known if DUPIXENT is safe and effective in children with CSU under 2 years of age, or who weigh less than 11 pounds (5 kg). to treat adults with bullous pemphigoid (BP). It is not known if DUPIXENT is safe and effective in children with BP under 18 years of age. to treat adults and children 6 years of age and older with allergic fungal rhinosinusitis (AFRS), who have had surgery on their nose or sinuses in the past. It is not known if DUPIXENT is safe and effective in children with AFRS under 6 years of age. DUPIXENT is not used to relieve sudden breathing problems and will not replace an inhaled rescue medicine or to treat any other forms of hives (urticaria). IMPORTANT SAFETY INFORMATION Do not use if you are allergic to dupilumab or to any of the ingredients in DUPIXENT®. Before using DUPIXENT, tell your healthcare provider about all your medical conditions, including if you: have eye problems. have a parasitic (helminth) infection. are scheduled to receive any vaccinations. You should not receive a “live vaccine” right before and during treatment with DUPIXENT. are pregnant or plan to become pregnant. It is not known whether DUPIXENT will harm your unborn baby. A pregnancy registry for women who take DUPIXENT during pregnancy collects information about the health of you and your baby. are breastfeeding or plan to breastfeed. It is not known whether DUPIXENT passes into your breast milk. A pregnancy registry for women who take DUPIXENT during pregnancy collects information about the health of you and your baby. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you are taking oral, topical, or inhaled corticosteroid medicines; have asthma and use an asthma medicine; or have AD, CRSwNP, EoE, PN, COPD, CSU, BP, or AFRS and also have asthma. Do not change or stop your other medicines, including corticosteroid medicine or other asthma medicine, without talking to your healthcare provider. This may cause other symptoms that were controlled by those medicines to come back. DUPIXENT can cause serious side effects, including: Allergic reactions. DUPIXENT can cause allergic reactions, including skin reactions, that can sometimes be severe. Stop using DUPIXENT and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms: breathing problems or wheezing, swelling of the face, lips, mouth, tongue or throat, fainting, dizziness, feeling lightheaded, fast pulse, fever, hives, skin rash, including rash that looks like a bullseye, painful red or blue bumps under the skin, or red pus-filled spots on the skin, general ill feeling, itching, swollen lymph nodes, nausea or vomiting, joint pain, or cramps in your stomach area. Eye problems. Tell your healthcare provider right away if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision. Your healthcare provider may send you to an ophthalmologist for an exam if needed. Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive DUPIXENT. This may happen in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. Tell your healthcare provider right away if you get: rash, chest pain, worsening shortness of breath, brown or dark colored urine, persistent fever, or a feeling of pins and needles or numbness of your arms or legs. Psoriasis. This can happen in people with atopic dermatitis and asthma who receive DUPIXENT. Tell your healthcare provider about any new skin symptoms. Your healthcare provider may send you to a dermatologist for an examination if needed. Joint aches and pain. Some people who use DUPIXENT have had trouble walking or moving due to their joint symptoms, and in some cases needed to be hospitalized. Tell your healthcare provider about any new or worsening joint symptoms. Your healthcare provider may stop DUPIXENT if you develop joint symptoms. The most common side effects: Eczema: injection site reactions; eye problems, including eye and eyelid inflammation, redness, swelling, itching, eye infection, dry eye, and blurred vision; cold sores in your mouth or on your lips; and high count of a certain white blood cell (eosinophilia). Asthma: injection site reactions; high count of a certain white blood cell (eosinophilia); pain in the throat (oropharyngeal pain); and parasitic (helminth) infections. Chronic Rhinosinusitis with Nasal Polyps: injection site reactions; eye problems, including eye and eyelid inflammation, redness, swelling, itching, eye infection, and blurred vision; high count of a certain white blood cell (eosinophilia), stomach problems (gastritis); joint pain (arthralgia); trouble sleeping (insomnia); and toothache. Eosinophilic Esophagitis: injection site reactions; upper respiratory tract infections; cold sores in your mouth or on your lips; and joint pain (arthralgia). Prurigo Nodularis: eye problems, including eye and eyelid inflammation, redness, swelling, itching, and blurred vision; herpes virus infections; common cold symptoms (nasopharyngitis); dizziness; muscle pain; and diarrhea. Chronic Obstructive Pulmonary Disease: injection site reactions; common cold symptoms (nasopharyngitis); high count of a certain white blood cell (eosinophilia); viral infection; back pain; inflammation inside the nose (rhinitis); diarrhea; stomach problems (gastritis); joint pain (arthralgia); toothache; headache; and urinary tract infection. Chronic Spontaneous Urticaria: injection site reactions. Bullous Pemphigoid: joint pain (arthralgia); eye problems, including eye and eyelid inflammation, redness, swelling, itching, and blurred vision; and herpes virus infections. Allergic Fungal Rhinosinusitis: injection site reactions; eye problems, including eye and eyelid inflammation, redness, swelling, itching, eye infection, and blurred vision; high count of a certain white blood cell (eosinophilia); stomach problems (gastritis); joint pain (arthralgia); trouble sleeping (insomnia); and toothache. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of DUPIXENT. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Use DUPIXENT exactly as prescribed by your healthcare provider. It’s an injection given under the skin (subcutaneous injection). Your healthcare provider will decide if you or your caregiver can inject DUPIXENT. Do not try to prepare and inject DUPIXENT until you or your caregiver have been trained by your healthcare provider. In children 12 years of age and older, it’s recommended DUPIXENT be administered by or under supervision of an adult. In children 6 months to less than 12 years of age, DUPIXENT should be given by a caregiver. Please see accompanying full Prescribing Information including Patient Information. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X. About Sanofi Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation Dupixent® (dupilumab) for the treatment of children aged 2 to 11 years with chronic spontaneous urticaria; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, including Dupixent for the treatment of chronic pruritus of unknown origin, lichen simplex chronicus, and other potential indications; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products (such as Dupixent) and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron’s Products (such as Dupixent) and Regeneron’s Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron’s Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes to drug pricing regulations and requirements and Regeneron’s pricing strategy; other changes in laws, regulations, and policies affecting the healthcare industry; competing products and product candidates (including biosimilar products) that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron 's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts ), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2025 . Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron . Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron 's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals). Sanofi Disclaimers or Forward-Looking Statements This press release contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions regarding the marketing and other potential of the product; regarding potential future events and revenues from the product. Words such as “expect,” “anticipate,” “believe,” “intend,” “estimate,” “plan,” “can,” “contemplate,” “could,” “is designed to,” “may,” “might,” “potential,” “objective,” "attempt," “target,” “project,” "strategy," "strive," "desire," “predict,” “forecast,” “ambition,” “guideline,” "seek," “should,” “will,” "goal," or the negative of these and similar expressions are intended to identify forward-looking statements. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi , that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks, uncertainties and assumptions include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful; authorities’ decisions regarding whether and when to approve a product candidate; political pressure in the United States to mandate lower drug prices including “most favored nation” pricing for State Medicaid programs; the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues; competition in general; risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the French Markets Authority (AMF) made by Sanofi , including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2025 or contained in our periodic reports on Form 6-K. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. In light of these risks, uncertainties and assumptions, you should not place undue reliance on any forward-looking statements contained herein. All trademarks mentioned in this press release are the property of the Sanofi group except for VelociSuite and Regeneron Genetics Center. ________________________ 1 Data on File Source: Regeneron Pharmaceuticals, Inc.