Bevacizumab biosimilar (Celltrion)

The U.S. FDA approved STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) as interchangeable with the reference products PROLIA® (denosumab) and XGEVA® (denosumab), respectively, for all approved indications, effective as of October 29, 2025 The interchangeability (IC) designations of STOBOCLO and OSENVELT were granted based not only on the comparative clinical data – including pharmacokinetics, efficacy, safety and an immunogenicity study in postmenopausal women with osteoporosis[1] - but also on analytical data demonstrating similarity of STOBOCLO and OSENVELT versus the reference product The IC designations enhance patient access and provider choice in the treatment of osteoporosis-related fracture as well as cancer-related bone loss INCHEON, South Korea, Oct. 30, 2025 /PRNewswire/ -- Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) as interchangeable biosimilars to the reference products PROLIA® (denosumab) and XGEVA® (denosumab), respectively, for all approved indications. The interchangeability (IC) designation is a regulatory designation granted by the FDA, which means STOBOCLO and OSENVELT may now be substituted at the pharmacy for the reference products without consulting the prescriber, subject to state laws.[2] "Today's IC designations reinforce confidence in STOBOCLO and OSENVELT among physicians and pharmacists, facilitating a more seamless switch from the reference products to our denosumab biosimilars," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "Building on our strong heritage in biosimilars, Celltrion remains committed to offering more affordable and much-needed treatment options to patients living with skeletal diseases, creating greater potential to deliver savings to patients and the U.S. healthcare system." The interchangeability designations of STOBOCLO and OSENVELT were based on the comprehensive evidence including the clinical results from Phase III clinical trials in postmenopausal women with osteoporosis designed to evaluate the efficacy, pharmacodynamics (PD), pharmacokinetics (PK), safety and immunogenicity of denosumab biosimilar to its reference product. [1] STOBOCLO and OSENVELT were introduced in the U.S. market in July 2025. STOBOCLO is currently available in 60 mg/mL injection and OSENVELT is offered in 120 mg/1.7 mL (70 mg/mL) injection. According to recent FDA draft guidance, biosimilar applicants can request an interchangeability designation using existing data from their Biologics License Application (BLA). Previously, the FDA granted this status only to biosimilars that submitted multiple switch studies meeting additional data criteria. About STOBOCLO® (denosumab-bmwo) [3] STOBOCLO® (denosumab-bmwo) is a receptor activator of NF-κb ligand (RANKL) inhibitor referencing PROLIA ® (denosumab). STOBOCLO 60 mg/mL injection is approved by the FDA based on comprehensive data and clinical evidence confirming the therapeutic equivalence to PROLIA. In the U.S., STOBOCLO is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. INDICATIONS STOBOCLO® (denosumab-bmwo) is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture to increase bone mass in men with osteoporosis at high risk for fracture or in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer of glucocorticoid-induced osteoporosis in men and women at high risk for fracture to increase bone mass in women at high risk for fracture receiving an adjuvant aromatase inhibitor therapy for breast cancer IMPORTANT SAFETY INFORMATION WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE Patients with advanced chronic kidney disease, including those on dialysis, face a higher risk of severe hypocalcemia after denosumab administration, with reported cases leading to hospitalization, life-threatening events, and fatalities. The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia in these patients Before starting STOBOCLO® (denosumab-bmwo) in advanced chronic kidney disease patients, assess for CKD-MBD. Treatment should be supervised by a healthcare provider experienced in diagnosing and managing CKD-MBD. STOBOCLO is contraindicated in hypocalcemia, pregnant women, and in patients with known hypersensitivity to denosumab. Severe Hypocalcemia: Ensure adequate calcium and vitamin D; monitor for severe hypocalcemia. Drug Products with Same Active Ingredient: Do not use with other denosumab products. Hypersensitivity : If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of STOBOCLO. Osteonecrosis of the Jaw (ONJ): ONJ can occur in patients on STOBOCLO. Conduct oral exams before treatment; maintain oral hygiene; consider discontinuation of STOBOCLO if ONJ develops. Atypical Subtrochanteric and Diaphyseal Femoral Fractures: Monitor for thigh, hip, or groin pain; evaluate for fractures. Interruption of STOBOCLO therapy should be considered, pending a benefit-risk assessment, on an individual basis. Multiple Vertebral Fractures (MVF) Following Discontinuation of Treatment: Increased risk post-discontinuation of denosumab; transition to alternative therapy if discontinuing STOBOCLO. Serious Infections: Higher risk in denosumab users; assess benefit-risk profile, especially in immunocompromised patients. Assess the benefit-risk profile before starting STOBOCLO and reconsider its use if serious infections develop. Dermatologic Adverse Reactions: Consider discontinuing STOBOCLO if severe dermatitis, eczema, or rashes occur. Musculoskeletal Pain: Consider discontinuation of STOBOCLO if severe pain develops. Bone Turnover Suppression: In clinical trials in women with postmenopausal osteoporosis, denosumab significantly suppressed bone remodelling; patients should be monitored for these outcomes. Hypercalcemia in Pediatrics Patients with Osteogenesis Imperfecta: Not for pediatric use; hypercalcemia reported in patients osteogenesis imperfecta treated with denosumab products. Most common Adverse Reactions: In (>5%) of patients with: Postmenopausal osteoporosis were back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, and cystitis. Pancreatitis has been reported in clinical trials. Male osteoporosis were back pain, arthralgia, and nasopharyngitis. Glucocorticoid-induced osteoporosis (> 3%) were back pain, hypertension, bronchitis, and headache. Bone loss due to hormone ablation for cancer (≥ 10%) were arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials. For more information, see Full Prescribing Information including Boxed Warning . To learn more about the STOBOCLO REMs program please visit stoboclorems.com . About OSENVELT® (denosumab-bmwo)[4] OSENVELT® (denosumab-bmwo) is a receptor activator of NF-κb ligand (RANKL) inhibitor referencing XGEVA ® (denosumab). OSENVELT 120 mg/1.7 mL (70 mg/mL) injection is approved by the FDA based on a robust clinical trial and comprehensive data confirming the therapeutic equivalence to XGEVA. In the U.S., OSENVELT is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy. INDICATION OSENVELT® (denosumab-bmwo) is indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. IMPORTANT SAFETY INFORMATION Contraindications: Patients with hypocalcemia or with known clinically significant hypersensitivity to denosumab products. Drug Products with Same Active Ingredient. Patients receiving OSENVELT should not receive other denosumab products concomitantly. Hypersensitivity. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of OSENVELT. Hypocalcemia. Severe hypocalcemia can occur, and fatal cases have been reported. Monitor calcium levels and calcium and vitamin D intake. Osteonecrosis of the Jaw (ONJ): ONJ can occur in patients on OSENVELT. Conduct oral exams and appropriate preventive dentistry before and during treatment; maintain oral hygiene and avoid invasive dental procedures; consider discontinuation of OSENVELT if ONJ develops. Atypical Subtrochanteric and Diaphyseal Femoral Fractures: Monitor for thigh, hip, or groin pain; evaluate for fractures. Interruption of OSENVELT therapy should be considered, pending a benefit-risk assessment, on an individual basis. Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone and in Patients with Growing Skeletons. Clinically significant hypercalcemia, potentially requiring hospitalization, can occur within a year after stopping denosumab in patients with giant cell tumor of bone or growing skeletons; monitor serum calcium and manage calcium and vitamin D needs post-discontinuation. Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation. Increased risk post-discontinuation of denosumab; evaluate for risk for vertebral fractures after discontinuing OSENVELT. Embryo-Fetal Toxicity. Denosumab may cause fetal harm; verify pregnancy status before starting OSENVELT and advise effective contraception during treatment and for 5 months after the last dose. Most common Adverse Reactions: Bone Metastasis from Solid Tumors (≥ 25%) were fatigue/asthenia, hypophosphatemia, and nausea. In patients (≥ 10%) with: Multiple Myeloma were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache; Giant Cell Tumor of Bone were arthralgia, headache, nausea, back pain, fatigue, and pain in extremity. Hypercalcemia of Malignancy (> 20%) were nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea. For more information, see Full Prescribing Information . About Celltrion , Inc. Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website . and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook. About Celltrion USA Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion's FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (Ustekinumab-stba) STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo), OMLYCLO® (omalizumab-igec), and EYDENZELT® (aflibercept-boav) as well as the novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit . and stay updated with our latest news and events on our social media - LinkedIn FORWARD-LOOKING STATEMENT Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion, Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion, Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect to the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements. Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. Trademarks STOBOCLO® and OSENVELT® are registered trademarks of Celltrion, Inc. PROLIA® and XGEVA® are registered trademarks of Amgen Inc. References US-CT-P41-25-00008 For further information please contact: Katie Gallagher [email protected] +1 617-657-1324 SOURCE Celltrion WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Third quarter 2025 revenues increased 1% to $3.75 billion versus third quarter 2024 Dupixent® 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 charge FDA approved Libtayo® as the first and only immunotherapy for high-risk adjuvant cutaneous squamous cell carcinoma (CSCC); EMA's CHMP adopted positive opinion Positive 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 "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 Progress Regeneron 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 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 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: A reconciliation of full year 2025 GAAP to non-GAAP financial guidance is included below: 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. TABLE 1 TABLE 2 TABLE 3 RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited) (continued) TABLE 4 TABLE 5 Source: Regeneron Pharmaceuticals, Inc.