Pozelimab

Third quarter 2025 revenues increased 1% to $3.75 billion versus third quarter 2024Dupixent® global net sales (recorded by Sanofi) increased 27% to $4.86 billion EYLEA HD® U.S. net sales increased 10% to $431 million; total EYLEA HD and EYLEA® U.S. net sales decreased 28% to $1.11 billion GAAP EPS of $13.62 and non-GAAP EPS(a) of $11.83; third quarter 2025 includes unfavorable $0.68 impact from acquired IPR&D chargeFDA approved Libtayo® as the first and only immunotherapy for high-risk adjuvant cutaneous squamous cell carcinoma (CSCC); EMA's CHMP adopted positive opinionPositive Phase 3 results reported from trials in generalized myasthenia gravis, fibrodysplasia ossificans progressiva (FOP), and cat and birch allergies; updated positive data reported from pivotal trial in children with profound genetic hearing loss TARRYTOWN, N.Y., Oct. 28, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the third quarter of 2025 and provided a business update. "Regeneron had a solid financial quarter and made progress across our late-stage portfolio by securing new FDA approvals for Libtayo, Evkeeza, and Lynozyfic, receiving positive CHMP opinions for Libtayo and Dupixent, and sharing promising data across our oncology, obesity, allergy, and rare disease portfolios," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. "We were proud to receive one of the FDA’s first Commissioner's National Priority Vouchers for DB-OTO for a rare form of congenital hearing loss. We also donated our Ebola treatment, Inmazeb, to countries most at risk of outbreaks, reflecting our commitment to ensuring patients in need are able to access our novel medicines." Financial Highlights ($ in millions, except per share data) Q3 2025 Q3 2024 % ChangeTotal revenues $3,754 $3,721 1% GAAP net income $1,460 $1,341 9% GAAP net income per share - diluted $13.62 $11.54 18% Non-GAAP net income(a) $1,287 $1,462 (12%)Non-GAAP net income per share - diluted(a) $11.83 $12.46 (5%) "We were pleased with our third quarter 2025 performance, which highlights the commercial strength of Dupixent, EYLEA HD, and Libtayo, and reinforces our momentum toward delivering solid financial performance for the year while advancing transformative therapies to patients around the world," said Christopher Fenimore, Executive Vice President, Finance and Chief Financial Officer of Regeneron. "Our disciplined approach to capital allocation fuels innovation through targeted investments, all while delivering value to shareholders. In the first nine months of 2025, we reaffirmed our commitment to advancing U.S. innovation and manufacturing by investing nearly $5 billion in R&D and capital expenditures, predominantly within the United States. We also returned over $3 billion to shareholders via share repurchases and dividends, underscoring our commitment to long-term value creation." Business Highlights Key Pipeline ProgressRegeneron has approximately 45 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 September 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Dupixent in the European Union (EU) for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 years and older who remain symptomatic despite antihistamine treatment. The European Commission (EC) is expected to announce a final decision in the coming months. EYLEA HD (aflibercept) 8 mg In October 2025, the Company was notified by Catalent Indiana, LLC (Catalent), the manufacturing filler in the EYLEA HD Biologics License Application (BLA), that they received an official action indicated (OAI) letter from the FDA citing unresolved issues related to a July 2025 FDA general site inspection (not specific to EYLEA HD). Yesterday, the FDA issued a Complete Response Letter (CRL) for the pre-filled syringe supplemental BLA (sBLA). The sole approvability issue cited in the CRL relates to unresolved inspection findings at Catalent. The Company is planning to submit by January 2026 an application to include a new pre-filled syringe manufacturing filler in the EYLEA HD BLA. There is also an sBLA under review by the FDA for EYLEA HD every-four-week dosing and for the treatment of macular edema following retinal vein occlusion (RVO), which has a target action date in late November 2025. In addition, the Company has submitted an application to include an additional vial filler, with an FDA decision regarding this new vial filler expected by late December 2025. Libtayo (cemiplimab) In October 2025, the FDA approved an sBLA for Libtayo as an adjuvant treatment for adults with CSCC at high risk of recurrence after surgery and radiation, making Libtayo the first and only immunotherapy approved in this setting. The EMA's CHMP also adopted a positive opinion for the adjuvant treatment of CSCC, and the EC is expected to announce a final decision in the coming months.In September 2025, Japan's Ministry of Health, Labour and Welfare (MHLW) approved Libtayo for an additional indication, as a monotherapy and in combination with chemotherapy for the treatment of adult patients with unresectable advanced or relapsed non-small cell lung cancer (NSCLC).In September 2025, the Company announced five-year follow-up results on overall survival from a Phase 3 trial, which evaluated Libtayo plus platinum-based chemotherapy versus chemotherapy alone as a first-line treatment for adults with locally advanced or metastatic NSCLC. The data demonstrate a more than double five-year overall survival rate of 19.4%, compared to 8.8% with chemotherapy alone, and was presented at the IASLC 2025 World Conference on Lung Cancer. Other Programs In August 2025, the Company announced that the primary and key secondary endpoints were met in a Phase 3 trial of cemdisiran (siRNA therapy), as both a monotherapy and in combination with pozelimab (C5 antibody), in adults with generalized myasthenia gravis. Cemdisiran monotherapy was numerically better than the combination treatment across these endpoints, showing a statistically significant 2.3-point placebo-adjusted improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score. A U.S. regulatory submission for cemdisiran monotherapy is planned for the first quarter of 2026, pending discussions with the FDA.In October 2025, updated data from the pivotal trial of DB-OTO, an AAV-based gene therapy, in children with profound genetic hearing loss due to variants of the otoferlin (OTOF) gene were published in the New England Journal of Medicine and presented at the annual American Academy of Otolaryngology-Head and Neck Surgery meeting. These latest results from the CHORD trial show 11 out of 12 participants have experienced clinically meaningful hearing improvements. A U.S. regulatory submission for DB-OTO is planned for the fourth quarter of 2025.In October 2025, the FDA selected DB-OTO to receive one of the Commissioner’s National Priority Vouchers, a pilot program intended to reduce the review time for certain drug and biologic applications to just one to two months.In September 2025, the Company announced the primary endpoint was met in a Phase 3 trial of garetosmab in adults with FOP, showing a 90% or greater reduction in new bone lesions (heterotopic ossification, or HO lesions) compared to placebo at 56 weeks, and a greater than 99% reduction in the total volume of new HO lesions. A U.S. regulatory submission for garetosmab is planned for the fourth quarter of 2025.In September 2025, the FDA approved Evkeeza® (evinacumab) for the treatment of homozygous familial hypercholesterolemia (HoFH), extending the already approved indication to include children from age 1 to less than 5 years old.In September 2025, the Company announced results from the Phase 3 trials evaluating its allergen-blocking antibodies in adults with moderate-to-severe cat allergies (REGN1908 and REGN1909) or birch allergies (REGN5713 and REGN5715). Both trials met their respective primary and key secondary endpoints, with single doses of the allergen-specific antibody blockers significantly reducing allergy symptoms compared to placebo at day 8. Additional Phase 3 development is planned to begin by the end of the year. Corporate Updates In September and October 2025, the Company reached resolution of its patent infringement litigation related to the Sandoz, Formycon, and Celltrion EYLEA (aflibercept) Injection 2 mg biosimilar products. The settlements preclude Sandoz, Formycon, and Celltrion from launching their biosimilar products in the United States until the fourth quarter of 2026. All intellectual property-related litigation with Sandoz, Formycon, and Celltrion in the United States has been dismissed. Third Quarter 2025 Financial Results Revenues ($ in millions) Q3 2025 Q3 2024 % ChangeNet product sales: EYLEA HD - U.S. $431 $392 10% EYLEA - U.S. 681 1,145 (41%)Total EYLEA HD and EYLEA - U.S. 1,112 1,537 (28%)Libtayo - U.S. 219 195 12% Libtayo - ROW* 146 94 55% Total Libtayo - Global 365 289 26% Praluent®- U.S. 67 53 26% Evkeeza - U.S. 43 32 34% Other products - Global 1 35 (97%)Total net product sales 1,588 1,946 (18%) Collaboration revenue: Sanofi 1,617 1,263 28% Bayer 345 391 (12%)Other 6 6 —% Other revenue 198 114 74% Total revenues $3,754 $3,720 1% * Rest of world (ROW) Net product sales of EYLEA HD increased in the third quarter of 2025, compared to the third quarter of 2024, due to higher sales volumes driven by increased demand, partly offset by a lower net selling price. Net product sales of EYLEA in the third quarter of 2025, compared to the third quarter of 2024, were negatively impacted by (i) lower sales volumes as a result of continued competitive pressures, loss in market share to compounded bevacizumab due to patient affordability constraints, and the continued transition of patients to EYLEA HD, and (ii) a lower net selling price. Sanofi collaboration revenue increased in the third quarter of 2025, compared to the third quarter of 2024, due to an increase in the Company's share of profits from the commercialization of antibodies, which were $1.46 billion and $1.09 billion in the third quarter of 2025 and 2024, respectively. The change in the Company's share of profits from commercialization of antibodies was driven by higher profits associated with an increase in Dupixent sales. Refer to Table 4 for a summary of collaboration revenue. Other revenue increased in the third quarter of 2025, compared to the third quarter of 2024, due to an increase in royalties and share of profits earned in connection with license agreements, which were $165 million and $91 million for the third quarter of 2025 and 2024, respectively. Operating Expenses GAAP % Non-GAAP(a) %($ in millions) Q3 2025 Q3 2024 Change Q3 2025 Q3 2024 ChangeResearch and development (R&D) $1,475 $1,272 16% $1,350 $1,146 18%Acquired in-process research and development (IPR&D) $83 $56 48% * * n/a Selling, general, and administrative (SG&A) $658 $714 (8%) $541 $613 (12%)Cost of goods sold (COGS) $281 $262 7% $227 $217 5%Gross margin on net product sales(b) 82% 87% 86% 89% Cost of collaboration and contract manufacturing (COCM)(c) $241 $229 5% * * n/a Other operating (income) expense, net $(10) $8 ** * $— ** * 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 third quarter of 2025, compared to the third quarter of 2024, driven by the advancement of the Company's late-stage clinical pipeline.Acquired IPR&D expenses for the third quarter of 2025 included an $80 million up-front payment in connection with the Company's license agreement with Hansoh Pharmaceuticals Group Company Limited. Acquired IPR&D expenses for the third quarter of 2024 included a $45 million development milestone in connection with the Company's collaboration agreement with Sonoma Biotherapeutics, Inc.GAAP and non-GAAP SG&A expenses decreased in the third quarter of 2025, compared to the third quarter of 2024, primarily due to lower charitable contributions to an independent not-for-profit patient assistance organization.GAAP and non-GAAP gross margin on net product sales decreased in the third quarter of 2025, compared to the third quarter of 2024, partly due to ongoing investments to support the Company's manufacturing operations. In addition, GAAP gross margin on net product sales decreased due to higher amortization expense associated with the Company's Libtayo intangible asset. Other Financial Information GAAP other income (expense), net included the recognition of net gains on marketable and other securities of $578 million in the third quarter of 2025, compared to $135 million in the third quarter of 2024. In the third quarter of 2025, the Company's GAAP effective tax rate (ETR) was 17.2%, compared to 10.2% in the third quarter of 2024. The GAAP ETR increased in the third quarter of 2025, compared to the third quarter of 2024, primarily due to the impact of the enactment of the "One Big Beautiful Bill Act" or "OBBBA," including a $45 million charge related to the re-measurement of the Company's U.S. net deferred tax assets, as well as lower tax benefits from less stock option exercises. In the third quarter of 2025, the non-GAAP ETR was 13.1%, compared to 10.7% in the third quarter of 2024. A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press release. Capital Allocation During the third quarter of 2025, the Company repurchased shares of its common stock and recorded the cost of the shares, or $663 million, as Treasury Stock. As of September 30, 2025, $2.156 billion remained available for share repurchases under the Company's share repurchase programs. In October 2025, the Company's board of directors declared a cash dividend of $0.88 per share on the Company's common stock and Class A stock, payable on December 5, 2025 to shareholders of record as of November 20, 2025. 2025 Financial Guidance* The Company's full year 2025 financial guidance consists of the following components: 2025 Guidance Prior UpdatedGAAP R&D $5.660–$5.790 billion $5.680–$5.750 billionNon-GAAP R&D(a) $5.100–$5.200 billion $5.150–$5.200 billionGAAP SG&A** $2.810–$2.940 billion $2.775–$2.845 billionNon-GAAP SG&A(a)** $2.450–$2.550 billion $2.400–$2.450 billionGAAP gross margin on net product sales Approximately 83% Approximately 82%Non-GAAP gross margin on net product sales(a) Approximately 86% UnchangedCOCM*** $1.000–$1.050 billion $950 million–$1.000 billionCapital expenditures*** $880–$950 million $850–$890 millionGAAP effective tax rate 11%–13% Approximately 14%Non-GAAP effective tax rate(a) 11%–13% Approximately 12% * The Company's 2025 financial guidance does not assume the completion of any business development transactions not completed as of the date of this press release** The Company's 2025 financial guidance includes potential matching program donations to Good Days, an independent national non-profit charitable organization, to support Good Days’ Retinal Vascular and Neovascular Disease Fund*** GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been or are expected to be recorded A reconciliation of full year 2025 GAAP to non-GAAP financial guidance is included below: Projected Range($ in millions) Low HighGAAP R&D $5,680 $5,750 Stock-based compensation expense 530 550 Non-GAAP R&D(a) $5,150 $5,200 GAAP SG&A $2,775 $2,845 Stock-based compensation expense 350 370 Litigation settlements 25 25 Non-GAAP SG&A(a) $2,400 $2,450 GAAP gross margin on net product sales 82% 82% Intangible asset amortization expense 2% 2% Stock-based compensation expense 1% 1% Other < 1% < 1% Non-GAAP gross margin on net product sales(a) 86% 86% GAAP ETR 14% 14% Income tax effect of GAAP to non-GAAP reconciling items 1% 1% Income tax expense: Charge related to enactment of OBBBA 1% 1% Non-GAAP ETR(a) 12% 12% (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 other operating (income) expense, net, 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 third quarter 2025 financial and operating results on Tuesday, October 28, 2025, 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 www.regeneron.com. 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 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 www.regeneron.com 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 drugs and product candidates 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") (including biosimilar versions of Regeneron's Products); 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), 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; 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, 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, 2024 and its Form 10-Q for the quarterly period ended September 30, 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). 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 CroweChristina ChanInvestor RelationsCorporate Affairs914-847-8790914-847-8827ryan.crowe@regeneron.com christina.chan@regeneron.com TABLE 1 REGENERON PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)(In millions) September 30, December 31, 2025 2024Assets: Cash and marketable securities $18,729.3 $17,912.6 Accounts receivable, net 5,687.1 6,211.9 Inventories 3,254.4 3,087.3 Property, plant, and equipment, net 5,002.3 4,599.7 Intangible assets, net 1,380.9 1,148.6 Deferred tax assets 3,846.7 3,314.1 Other assets 2,268.7 1,485.2 Total assets $40,169.4 $37,759.4 Liabilities and stockholders' equity: Accounts payable, accrued expenses, and other liabilities $5,741.3 $4,888.0 Finance lease liabilities 720.0 720.0 Deferred revenue 764.8 813.4 Long-term debt 1,985.5 1,984.4 Stockholders' equity 30,957.8 29,353.6 Total liabilities and stockholders' equity $40,169.4 $37,759.4 TABLE 2 REGENERON PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)(In millions, except per share data) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2025 2024 2025 2024 Revenues: Net product sales $1,587.7 $1,946.4 $4,634.3 $5,626.3 Collaboration revenue 1,968.4 1,660.1 5,360.3 4,450.9 Other revenue 198.2 114.2 464.0 335.6 3,754.3 3,720.7 10,458.6 10,412.8 Expenses: Research and development 1,475.0 1,271.5 4,224.1 3,719.9 Acquired in-process research and development 83.1 56.2 105.4 87.2 Selling, general, and administrative 657.8 714.4 1,925.0 2,162.2 Cost of goods sold 281.0 262.3 822.1 760.5 Cost of collaboration and contract manufacturing 240.6 228.8 694.0 644.6 Other operating (income) expense, net (10.0) 8.0 (10.0) 37.9 2,727.5 2,541.2 7,760.6 7,412.3 Income from operations 1,026.8 1,179.5 2,698.0 3,000.5 Other income (expense): Other income (expense), net 755.8 327.3 1,520.6 866.0 Interest expense (19.3) (13.8) (31.6) (44.7) 736.5 313.5 1,489.0 821.3 Income before income taxes 1,763.3 1,493.0 4,187.0 3,821.8 Income tax expense 303.3 152.4 526.7 326.9 Net income $1,460.0 $1,340.6 $3,660.3 $3,494.9 Net income per share - basic $14.09 $12.40 $34.83 $32.36 Net income per share - diluted $13.62 $11.54 $33.61 $30.23 Weighted average shares outstanding - basic 103.6 108.1 105.1 108.0 Weighted average shares outstanding - diluted 107.2 116.2 108.9 115.6 TABLE 3 REGENERON PHARMACEUTICALS, INC.RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited)(In millions, except per share data) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2025 2024 2025 2024 GAAP R&D $1,475.0 $1,271.5 $4,224.1 $3,719.9 Stock-based compensation expense 125.1 123.7 405.1 369.1 Acquisition and integration costs — 2.0 — 11.1 Non-GAAP R&D $1,349.9 $1,145.8 $3,819.0 $3,339.7 GAAP SG&A $657.8 $714.4 $1,925.0 $2,162.2 Stock-based compensation expense 92.0 83.1 279.0 251.9 Acquisition and integration costs — 8.2 0.8 36.7 Litigation settlements 25.0 10.0 25.0 10.0 Non-GAAP SG&A $540.8 $613.1 $1,620.2 $1,863.6 GAAP COGS $281.0 $262.3 $822.1 $760.5 Stock-based compensation expense 19.9 18.3 60.3 57.4 Acquisition and integration costs — 0.5 — 1.7 Intangible asset amortization expense 33.7 26.1 94.8 74.4 Non-GAAP COGS $227.4 $217.4 $667.0 $627.0 GAAP other operating (income) expense, net $(10.0) $8.0 $(10.0) $37.9 Change in fair value of contingent consideration — 8.0 — 37.9 Non-GAAP other operating (income) expense, net $(10.0) $— $(10.0) $— GAAP other income (expense), net $736.5 $313.5 $1,489.0 $821.3 Gains on marketable and other securities, net (577.7) (134.7) (967.6) (331.2)Non-GAAP other income (expense), net $158.8 $178.8 $521.4 $490.1 GAAP net income $1,460.0 $1,340.6 $3,660.3 $3,494.9 Total of GAAP to non-GAAP reconciling items above (282.0) 145.2 (102.6) 519.0 Income tax effect of GAAP to non-GAAP reconciling items 64.7 (23.4) 37.0 (84.4)Income tax expense: Charge related to enactment of OBBBA 44.5 — 44.5 — Non-GAAP net income $1,287.2 $1,462.4 $3,639.2 $3,929.5 Non-GAAP net income per share - basic $12.42 $13.53 $34.63 $36.38 Non-GAAP net income per share - diluted $11.83 $12.46 $32.87 $33.53 Shares used in calculating: Non-GAAP net income per share - basic 103.6 108.1 105.1 108.0 Non-GAAP net income per share - diluted 108.8 117.4 110.7 117.2 RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited) (continued) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2025 2024 2025 2024 Effective tax rate reconciliation: GAAP ETR 17.2% 10.2% 12.6% 8.6%Income tax effect of GAAP to non-GAAP reconciling items (2.4%) 0.5% (0.8%) 0.9%Income tax expense: Charge related to enactment of OBBBA (1.7%) —% (0.9%) —%Non-GAAP ETR 13.1% 10.7% 10.9% 9.5% Gross margin on net product sales reconciliation: GAAP gross margin on net product sales 82% 87% 82% 86%Intangible asset amortization expense 2% 1% 2% 2%Stock-based compensation expense 2% 1% 2% 1%Non-GAAP gross margin on net product sales 86% 89% 86% 89% Nine Months EndedSeptember 30, 2025 2024 Free cash flow reconciliation: Net cash provided by operating activities $3,808.2 $3,157.7 Capital expenditures (649.7) (556.3) Free cash flow $3,158.5 $2,601.4 TABLE 4 REGENERON PHARMACEUTICALS, INC.COLLABORATION REVENUE (Unaudited)(In millions) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2025 2024 2025 2024Sanofi collaboration revenue: Regeneron's share of profits in connection with commercialization of antibodies $1,455.5 $1,088.3 $3,755.7 $2,880.6 Reimbursement for manufacturing of commercial supplies 161.5 175.1 488.1 438.2 Total Sanofi collaboration revenue 1,617.0 1,263.4 4,243.8 3,318.8 Bayer collaboration revenue: Regeneron's share of profits in connection with commercialization of EYLEA 8 mg and EYLEA outside the United States 311.9 367.6 1,012.6 1,054.5 Reimbursement for manufacturing of commercial supplies 32.9 23.2 91.1 67.4 Total Bayer collaboration revenue 344.8 390.8 1,103.7 1,121.9 Other collaboration revenue 6.6 5.9 12.8 10.2 Total collaboration revenue $1,968.4 $1,660.1 $5,360.3 $4,450.9 TABLE 5 REGENERON PHARMACEUTICALS, INC.NET PRODUCT SALES OF REGENERON-DISCOVERED PRODUCTS (Unaudited)(In millions) Three Months EndedSeptember 30, 2025 2024 % Change U.S. ROW Total U.S. ROW Total (Total Sales)EYLEA HD(a) $430.6 $232.4 $663.0 $392.3 $75.2 $467.5 42%EYLEA(a) $680.6 $621.4 $1,302.0 $1,144.6 $856.5 $2,001.1 (35%)Total EYLEA HD and EYLEA $1,111.2 $853.8 $1,965.0 $1,536.9 $931.7 $2,468.6 (20%)Dupixent(b) $3,618.8 $1,238.2 $4,857.0 $2,824.7 $992.5 $3,817.2 27%Libtayo(c) $219.1 $146.1 $365.2 $194.5 $94.1 $288.6 27%Praluent(d) $67.7 $148.0 $215.7 $52.9 $138.5 $191.4 13%Kevzara(b) $102.9 $51.1 $154.0 $72.7 $47.4 $120.1 28%Other products(e) $43.9 $28.0 $71.9 $68.2 $24.4 $92.6 (22%) Nine Months EndedSeptember 30, 2025 2024 % Change U.S. ROW Total U.S. ROW Total (Total Sales)EYLEA HD(a) $1,130.6 $620.5 $1,751.1 $896.5 $149.5 $1,046.0 67%EYLEA(a) $2,170.9 $2,068.8 $4,239.7 $3,576.7 $2,539.4 $6,116.1 (31%)Total EYLEA HD and EYLEA $3,301.5 $2,689.3 $5,990.8 $4,473.2 $2,688.9 $7,162.1 (16%)Dupixent(b) $9,453.2 $3,414.0 $12,867.2 $7,652.9 $2,797.5 $10,450.4 23%Libtayo(c) $659.4 $367.4 $1,026.8 $536.1 $313.8 $849.9 21%Praluent(d) $190.3 $440.7 $631.0 $179.0 $405.6 $584.6 8%Kevzara(b) $271.4 $151.2 $422.6 $187.8 $136.1 $323.9 30%Other products(e) $117.1 $81.5 $198.6 $124.4 $65.2 $189.6 5% 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.(a) 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.(b) 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(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 "Third Quarter 2025 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.

TARRYTOWN, N.Y. , Oct. 17, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Libtayo® (cemiplimab) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation. The European Commission is expected to make a final decision on the application in the coming months. Libtayo was approved by the U.S. Food and Drug Administration (FDA) for these patients in the U.S. earlier this month. The positive opinion is supported by results from the global Phase 3 C-POST trial investigating adjuvant Libtayo versus placebo in patients with CSCC at high risk of recurrence following surgery and radiation. In the trial, Libtayo reduced the risk of disease recurrence or death by 68% compared to placebo (hazard ratio [HR]: 0.32; 95% confidence interval [CI]: 0.20-0.51; p<0.0001). Fewer patients treated with Libtayo had locoregional or distant recurrence compared with those who received placebo (4% vs. 17% and 5% vs. 13%, respectively). Detailed data were published in the New England Journal of Medicine (NEJM) in May 2025 . The safety profile of Libtayo as adjuvant treatment of patients with CSCC at high risk of recurrence after surgery and radiation is consistent with the known safety profile for Libtayo monotherapy in advanced cancers. In the trial, adverse events (AEs) occurred in 91% of patients receiving Libtayo (n=205) and 89% of patients receiving placebo (n=204). Grade ≥3 AEs occurred in 24% and 14% of patients in the Libtayo arm and the placebo arm, respectively. The most common AEs occurring in at least 10% of patients who received Libtayo were fatigue, pruritus, rash, diarrhea, arthralgia, hypothyroidism and maculo-papular rash. The only grade ≥3 AE that occurred in more than 2% of patients in the Libtayo arm was hypertension. AEs led to permanent discontinuation of treatment in 10% of patients who received Libtayo and 2% of patients who received placebo. Two patients in each arm experienced an AE leading to death. About the Phase 3 TrialC-POST was a randomized, placebo-controlled, double-blind, multicenter, global Phase 3 trial investigating Libtayo versus placebo as adjuvant treatment for patients with features associated with a high risk of CSCC recurrence and who had completed surgery and post-operative radiation therapy. Trial participants were at high risk of recurrence due to nodal features (extracapsular extension or ≥3 involved lymph nodes) and/or non-nodal features (in-transit metastases, T4 lesion, perineural invasion, or locally recurrent tumor with ≥1 additional poor prognostic features). The trial enrolled 415 patients who were randomized to receive either Libtayo (n=209) or placebo (n=206) for up to 48 weeks. For the first 12 weeks, Libtayo 350 mg or placebo was administered intravenously every three weeks, followed by Libtayo 700 mg or placebo administered intravenously every six weeks for 36 weeks. About CSCCCutaneous squamous cell carcinoma (CSCC) is a type of non-melanoma skin cancer (NMSC), and one of the most common cancers in the world. In the EU, the incidence of NMSC overall is expected to increase by 40% by 2040. CSCC can often be treated successfully with surgery, but many patients may have a “high risk” form that is more aggressive, and they face an increased risk of recurrence and disease progression. About Regeneron in Cancer We aspire to turn revolutionary discoveries into medicines that can transform the lives of those impacted by cancer. Our team around the world is driven to solve the needs and challenges of those affected by one of the most serious diseases of our time. Backed by our legacy of scientific innovation and a deep understanding of biology, genetics and the immune system, we’re pursuing potential therapies across more than 30 types of solid tumors and blood cancers. Our cancer strategy is powered by cutting-edge technologies and therapies that can be flexibly combined to investigate potentially transformative treatments for patients. Oncology assets in clinical development comprise nearly half of Regeneron’s pipeline, and include checkpoint inhibitors, bispecific antibodies and costimulatory bispecific antibodies. Our approved PD-1 inhibitor Libtayo serves as the backbone of many of our investigational combinations. To complement our extensive in-house capabilities, we collaborate with patients, healthcare providers, governments, biopharma companies and each other to further our shared goals. Together, we are united in the mission to serve as a beacon of transformation in cancer care. About Libtayo Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron 's proprietary VelocImmune® technology. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. Libtayo has been approved by regulatory authorities in more than 30 countries in one or more indications, including for certain adult patients with advanced basal cell carcinoma (BCC), CSCC that is advanced or at high risk of recurrence, advanced non-small cell lung cancer (NSCLC) and advanced cervical cancer. In the U.S., the generic name for Libtayo in its approved indications is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. FDA. Outside of the U.S., the generic name of Libtayo in its approved indications is cemiplimab.   The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority. U.S. FDA-approved Indications Libtayo is a prescription medicine used to treat: Adults with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC): that has spread or cannot be cured by surgery or radiation, or to help prevent CSCC from coming back if your CSCC is at high risk of coming back after it has been removed by surgery and radiation. Adults with a type of skin cancer called basal cell carcinoma (BCC) when your BCC cannot be removed by surgery (locally advanced BCC) or when it has spread (metastatic BCC) and have received treatment with a hedgehog pathway inhibitor (HHI), or cannot receive treatment with a HHI. Adults with a type of lung cancer called non-small cell lung cancer (NSCLC). LIBTAYO may be used in combination with chemotherapy that contains a platinum medicine as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene. LIBTAYO may be used alone as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high “PD-L1,” and your tumor does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene. that has spread or cannot be cured by surgery or radiation, or to help prevent CSCC from coming back if your CSCC is at high risk of coming back after it has been removed by surgery and radiation. LIBTAYO may be used in combination with chemotherapy that contains a platinum medicine as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene. LIBTAYO may be used alone as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high “PD-L1,” and your tumor does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene. It is not known if Libtayo is safe and effective in children.  IMPORTANT SAFETY INFORMATION FOR U.S. PATIENTS  What is the most important information I should know about LIBTAYO?LIBTAYO is a medicine that may treat certain cancers by working with your immune system. LIBTAYO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended. Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including: Lung problems: cough, shortness of breath, or chest pain Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual, stools that are black, tarry, sticky or have blood or mucus, or severe stomach-area (abdomen) pain or tenderness Liver problems: yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach-area (abdomen), dark urine (tea colored), or bleeding or bruising more easily than normal Hormone gland problems: headache that will not go away or unusual headaches, eye sensitivity to light, eye problems, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, feeling more hungry or thirsty than usual, urinating more often than usual, hair loss, feeling cold, constipation, your voice gets deeper, dizziness or fainting, or changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, or loss of appetite Skin problems: rash, itching, skin blistering or peeling, painful sores or ulcers in mouth or nose, throat, or genital area, fever or flu-like symptoms, or swollen lymph nodes Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with LIBTAYO. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath or swelling of ankles, confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs, double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight, persistent or severe muscle pain or weakness, muscle cramps, low red blood cells, or bruising Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include: nausea, vomiting, chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain, or facial swelling Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ or tissue transplant that you have had Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with LIBTAYO. Your healthcare provider will monitor you for these complication Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with LIBTAYO. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with LIBTAYO if you have severe side effects. Before you receive LIBTAYO, tell your healthcare provider about all your medical conditions, including if you: have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus have received an organ or tissue transplant, including corneal transplant have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic) have received radiation treatment to your chest area have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome are pregnant or plan to become pregnant. LIBTAYO can harm your unborn baby Females who are able to become pregnant: Your healthcare provider will give you a pregnancy test before you start treatment You should use an effective method of birth control during your treatment and for at least 4 months after your last dose of LIBTAYO. Talk to your healthcare provider about birth control methods that you can use during this time Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LIBTAYO Your healthcare provider will give you a pregnancy test before you start treatment You should use an effective method of birth control during your treatment and for at least 4 months after your last dose of LIBTAYO. Talk to your healthcare provider about birth control methods that you can use during this time Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LIBTAYO are breastfeeding or plan to breastfeed. It is not known if LIBTAYO passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of LIBTAYO Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. The most common side effects of LIBTAYO when used alone to treat CSCC that has spread or cannot be cured by surgery or radiation, BCC or NSCLC include tiredness, muscle or bone pain, rash, diarrhea, and low levels of red blood cells (anemia). The most common side effects of LIBTAYO when used alone to help prevent CSCC from coming back include rash and itching. The most common side effects of LIBTAYO when used in combination with platinum-containing chemotherapy to treat NSCLC include hair loss, muscle or bone pain, nausea, tiredness, numbness, pain, tingling, or burning in your hands or feet, and decreased appetite. These are not all the possible side effects of LIBTAYO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Regeneron Pharmaceuticals at 1-877-542-8296. Please see full Prescribing Information, including Medication Guide.  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, 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 or authorized fully human monoclonal antibodies. This includes Dupixent® (dupilumab), Libtayo, 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. 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. 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 Libtayo® (cemiplimab); the impact of the opinion adopted by the European Medicines Agency's Committee for Medicinal Products for Human Use discussed in this press release on the potential approval by the European Commission of Libtayo as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (“CSCC”) at high risk of recurrence after surgery and radiation; 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 Libtayo for the treatment of CSCC in the European Union as discussed in this press release, Libtayo as a monotherapy or in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers, and Regeneron’s other oncology assets in clinical development referenced in this press release; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products (such as Libtayo) 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 or any potential regulatory approval of Regeneron’s Products (such as Libtayo) and Regeneron’s Product Candidates; 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 Libtayo) 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 in laws, regulations, and policies affecting the healthcare industry; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates (including biosimilar versions of Regeneron’s Products); 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, 2024 and its Form 10-Q for the quarterly period ended June 30, 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). Source: Regeneron Pharmaceuticals, Inc.