Linvoseltamab

Acceptance follows resolution of third-party fill/finish manufacturing issues FDA decision expected by July 10 , 2025 TARRYTOWN, N.Y. , Feb. 11, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals , Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for linvoseltamab for the treatment of adult patients with relapsed/refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy or those who received three prior lines of therapy and are refractory to the last line of therapy. The target action date for the FDA decision is July 10, 2025 . Acceptance of the BLA resubmission follows the resolution of third-party fill/finish manufacturing issues, which was the sole approvability issue identified by the FDA in the previous submission. The BLA is supported by data from the pivotal LINKER-MM1 trial investigating linvoseltamab in R/R MM, and linvoseltamab is also under review by the European Medicines Agency (EMA) for the same patient population. Linvoseltamab is investigational and has not been approved by any regulatory authority. About Multiple MyelomaAs the second most common blood cancer, there are over 187,000 new cases of MM diagnosed globally every year, with more than 36,000 diagnosed and 12,000 deaths anticipated in the U.S. in 2025. In the U.S., there are approximately 8,000 people who have MM that has progressed after three lines of therapy, and 4,000 whose disease has progressed after four or more therapies. The disease is characterized by the proliferation of cancerous plasma cells (MM cells) that crowd out healthy blood cells in the bone marrow, infiltrate other tissues and cause potentially life-threatening organ injury. Despite treatment advances, MM is not curable and while current treatments are able to slow progression of the cancer, most patients will ultimately experience cancer progression and require additional therapies. About the Linvoseltamab Clinical Development ProgramLinvoseltamab is an investigational BCMAxCD3 bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on MM cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing. The ongoing, open-label, multicenter Phase 1/2 dose-escalation and dose-expansion LINKER-MM1 trial is investigating linvoseltamab in 282 enrolled patients with relapsed/refractory MM. The Phase 1 dose-escalation portion of the trial – which is now complete – primarily assessed safety, tolerability and dose-limiting toxicities across nine dose levels of linvoseltamab and explored different administration regimens. The ongoing Phase 2 dose expansion portion is assessing the safety and anti-tumor activity of linvoseltamab, with the primary endpoint of objective response rate. Key secondary endpoints include duration of response, progression-free survival, rate of minimum residual disease negative status and overall survival. Eligibility in the Phase 2 portion requires patients to have received at least three prior lines of therapy or have triple-class refractory MM. Linvoseltamab is administered with an initial step-up dosing regimen followed by the full 200 mg dose administered weekly. At week 16, all patients transition to every two-week dosing. A response-adapted regimen further enables patients to shift to every four-week dosing if they achieve a very good partial response or better and have completed at least 24 weeks of therapy. The regimen requires a total of two 24-hour hospitalizations for safety monitoring. Linvoseltamab is being investigated in a broad clinical development program exploring its use as a monotherapy as well as in combination regimens across different lines of therapy in MM, including earlier lines of treatment, as well as plasma cell precursor disorders. They include evaluating linvoseltamab in a Phase 1b trial (LINKER-MM2) in combination with other cancer treatments in R/R MM as well as a Phase 3 confirmatory trial (LINKER-MM3) as a monotherapy in R/R MM. For more information on Regeneron’s clinical trials in blood cancer, visit the clinical trials website, or contact via clinicaltrials@regeneron.com or 844-734-6643. About Regeneron in Hematology At Regeneron, we’re applying more than three decades of biology expertise with our proprietary VelociSuite® technologies to develop medicines for patients with diverse blood cancers and rare blood disorders. Our blood cancer research is focused on bispecific antibodies that are being investigated both as monotherapies and in various combinations and emerging therapeutic modalities. Together, they provide us with unique combinatorial flexibility to develop customized and potentially synergistic cancer treatments. Our research and collaborations to develop potential treatments for rare blood disorders include explorations in antibody medicine, gene editing and gene-knockout technologies, and investigational RNA-approaches focused on depleting abnormal proteins or blocking disease-causing cellular signaling. 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 fully human monoclonal antibodies. This includes Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz® (pozelimab-bbfg). In addition, REGEN-COV® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024. 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 linvoseltamab; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, such as linvoseltamab for the treatment of relapsed/refractory (“R/R”) multiple myeloma (including in the United States based on the Biologics License Application (“BLA”) resubmission discussed in this press release or in the European Union as referenced in this press release); whether the resolution of the third-party fill/finish manufacturing issues discussed in this press release will be sufficient for purposes of potential approval of the resubmitted BLA for linvoseltamab in R/R multiple myeloma by the U.S. Food and Drug Administration; 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), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron’s Products and Regeneron’s Product Candidates (such as linvoseltamab); 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; safety issues resulting from the administration of Regeneron’s Products and Regeneron’s Product Candidates (such as linvoseltamab) 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 of Regeneron’s Products from third-party payers, including private payer 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 payers and new policies and procedures adopted by such payers; 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 . 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.

Fourth quarter 2024 revenues increased 10% to $3 .79 billion versus fourth quarter 2023 Full year 2024 revenues increased 8% to $14 .20 billion versus 2023; excluding RonapreveTM(a)(b), revenues increased 10% Fourth quarter 2024 Dupixent® global net sales (recorded by Sanofi) increased 15% to $3 .70 billion versus fourth quarter 2023; full year 2024 Dupixent global net sales increased 22% to $14 .15 billion versus 2023 Fourth quarter 2024 U.S. net sales for EYLEA HD® and EYLEA® increased 2% versus fourth quarter 2023 to $1 .50 billion, including $305 million from EYLEA HD; full year 2024 U.S. net sales for EYLEA HD and EYLEA increased 1% versus 2023 to $5 .97 billion versus 2023, including $1.20 billion from EYLEA HD Fourth quarter 2024 Libtayo® global net sales increased 50% to $367 million versus fourth quarter 2023; full year 2024 Libtayo global net sales increased 40% to $1.22 billion versus 2023 Fourth quarter 2024 GAAP diluted EPS of $8.06 and non-GAAP diluted EPS(a) of $12.07 ; fourth quarter 2024 includes unfavorable $0.11 impact from acquired IPR&D charge Initiation of quarterly cash dividend program, $0.88 dividend declared; additional $3 .0 billion share repurchase program authorized, bringing current repurchase capacity to ~$4.5 billion Regulatory applications submitted to FDA for EYLEA HD pre-filled syringe, Dupixent in bullous pemphigoid, odronextamab in follicular lymphoma, and linvoseltamab in multiple myeloma Positive Phase 3 results reported for EYLEA HD in retinal vein occlusion (RVO) and Libtayo in high-risk adjuvant cutaneous squamous cell carcinoma (CSCC) TARRYTOWN, N.Y. , Feb. 04, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the fourth quarter and full year 2024 and provided a business update. " Regeneron 's financial and commercial strength allows for continued investment in our industry-leading R&D pipeline, while simultaneously returning capital to our shareholders through our newly initiated dividend program and increased share repurchase capacity," said Leonard S. Schleifer , M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron . "In 2025, we will continue to focus on our four blockbuster medicines as we progress our approximately 40 investigational candidates covering dozens of disease states with expansive market potential." Financial Highlights "2024 was another year of top- and bottom-line growth for Regeneron . This strong financial performance, coupled with the strength of our balance sheet, allows us to initiate a quarterly cash dividend program as well as increase our current share repurchase capacity to approximately $4.5 billion ," said Christopher Fenimore , Executive Vice President, Finance and Chief Financial Officer of Regeneron . Business Highlights Key Pipeline Progress Regeneron has approximately 40 product candidates in clinical development, including a number of marketed products for which it is investigating additional indications. Updates from the clinical pipeline include: EYLEA HD (aflibercept) 8 mg The Company announced that the primary endpoint was met in the Phase 3 QUASAR trial investigating EYLEA HD for the treatment of patients with macular edema following RVO, including those with central, branch, and hemiretinal vein occlusions. In the trial, patients treated with EYLEA HD every 8 weeks (after initial monthly doses) experienced non-inferior vision gains compared to those treated with the approved monthly dosing regimen of EYLEA, the current standard of care. The Company plans to submit a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) in the first quarter of 2025. A regulatory application for a pre-filled syringe was submitted to the FDA, with an FDA decision expected by mid-2025. Dupixent (dupilumab) In November 2024 , the European Commission (EC) approved Dupixent to treat eosinophilic esophagitis (EoE) in children aged 1 to 11 years, making Dupixent the first and only medicine indicated to treat these young patients. The FDA accepted for review the resubmission of an sBLA for Dupixent to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment, with a target action date of April 18, 2025 . An sBLA for Dupixent in bullous pemphigoid was submitted to the FDA. A Phase 3 study in lichen simplex chronicus was initiated. Libtayo (cemiplimab) The Company announced positive results from a Phase 3 trial of Libtayo, which demonstrated that adjuvant treatment with Libtayo was the first and only immunotherapy that led to a statistically significant and clinically meaningful improvement in the primary endpoint of disease-free survival (DFS) in patients with high-risk CSCC after surgery. A Phase 3 study of Libtayo administered intralesionally in patients with early-stage CSCC was initiated. Hematology Programs In January 2025 , the Company resubmitted to the FDA the BLA for linvoseltamab, a bispecific antibody targeting BCMA and CD3, in relapsed/refractory (R/R) multiple myeloma following resolution of third-party manufacturing issues. In January 2025 , the Company resubmitted to the FDA the BLA for odronextamab, a bispecific antibody targeting CD20 and CD3, in R/R follicular lymphoma. The Company presented new and updated data for odronextamab spanning several B-cell non-Hodgkin lymphoma (B-NHL) subtypes across earlier lines of treatment at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. The Company announced positive Phase 2 results for two antibodies targeting distinct domains of Factor XI. REGN7508 (catalytic domain) is designed to maximize anticoagulant activity while minimizing bleeding risk, and REGN9933 (A2 domain) is designed to provide an additional option for patients with the highest bleeding risk who would otherwise not be candidates for currently available anticoagulants. Per the Phase 2 results, there was a robust antithrombotic effect for each antibody, and no clinically relevant bleeding was observed. The Company announced positive updated data from a Phase 3 study of pozelimab (C5 antibody), in combination with cemdisiran (siRNA therapy), against ravulizumab, a standard-of-care C5 inhibitor, in patients with paroxysmal nocturnal hemoglobinuria (PNH). The study showed that the combination treatment helped patients achieve and maintain greater disease control, compared to ravulizumab. These results were presented at the 66th ASH Annual Meeting and Exposition. Other Programs The EC approved Kevzara® (sarilumab) for the treatment of polymyalgia rheumatica (PMR) and polyarticular juvenile idiopathic arthritis (pJIA). A Phase 3 study for mibavademab, an agonist antibody to leptin receptor (LEPR), in generalized lipodystrophy was initiated. Enrollment was completed in a Phase 2 study in obesity for trevogrumab, an antibody to myostatin (GDF8), in combination with semaglutide with and without garetosmab, an antibody to Activin A. A Phase 2 study for itepekimab, an antibody to IL-33, in chronic rhinosinusitis without nasal polyposis (CRSsNP) was initiated. A Phase 2 study for REGN7544, an antagonist antibody to NPR1 , in postural orthostatic tachycardia syndrome (POTS) was initiated. The Company shared initial data from the first patient in a Phase 1 study of linvoseltamab, in combination with Dupixent, in severe food allergy at the 43rd Annual J.P. Morgan Healthcare Conference . Corporate and Business Development Updates In February 2025 , the Company's board of directors approved the initiation of a quarterly cash dividend program and declared a cash dividend of $0.88 per share on the Company's common stock and Class A stock, payable on March 20, 2025 to shareholders of record as of February 20, 2025 . The Company intends to pay a cash dividend on a quarterly basis going forward, subject to market conditions and approval by the Company's board of directors in its sole discretion. In February 2025 , the Company's board of directors also authorized an additional $3 .0 billion share repurchase program, bringing the total current capacity to approximately $4.5 billion . Repurchases may be made from time to time at management's discretion through a variety of methods. The program has no time limit and can be discontinued at any time. In January 2025 , the Company entered into an agreement with Truveta Inc. pursuant to which the Company will sequence exomes and conduct genotyping and imputation of up to ten million de-identified consented volunteers using biospecimens provided by Truveta health system members across the United States . The Company announced its inclusion on the Dow Jones Sustainability World Index ( DJSI World ) for the sixth consecutive year, as well as its fifth consecutive inclusion on the Dow Jones Sustainability North America Index ( DJSI North America ). Select Upcoming 2025 Milestones Fourth Quarter and Full Year 2024 Financial Results Revenues EYLEA HD was approved by the FDA in August 2023 and net product sales in 2024 were driven by the transition of patients from other anti-VEGF products, including EYLEA, as well as new patients naïve to anti-VEGF therapy. Net product sales of EYLEA HD and EYLEA in the fourth quarter and full year 2024 were adversely impacted by a lower net selling price compared to the same periods of 2023. In addition, fourth quarter 2024 total EYLEA HD and EYLEA net product sales were favorably impacted by approximately $85 million as a result of higher wholesaler inventory levels for EYLEA, partially offset by lower wholesaler inventory levels for EYLEA HD, at the end of the fourth quarter 2024 compared to the end of the third quarter 2024. Sanofi collaboration revenue increased in the fourth quarter and full year 2024, compared to the same periods of 2023, due to an increase in the Company's share of profits from the commercialization of antibodies, which were $1 .043 billion and $886 million in the fourth quarter of 2024 and 2023, respectively, and $3 .924 billion and $3 .137 billion for full year 2024 and 2023, 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. Sanofi collaboration revenue in 2023 was positively impacted by the recognition of a $50 million sales-based milestone. Collaboration revenue for full year 2023 included $224 million in connection with the Company's share of global gross profits from sales of Ronapreve by Roche. Refer to Table 4 for a summary of collaboration revenue. Operating Expenses GAAP and non-GAAP R&D expenses increased in the fourth quarter and full year 2024, compared to the same periods in the prior year, driven by the advancement of the Company's mid- and late-stage clinical pipeline and higher headcount-related costs. Acquired IPR&D expense for full year 2024 included a $45 million development milestone in connection with the Company's collaboration agreement with Sonoma Biotherapeutics, Inc. Acquired IPR&D expense for full year 2023 included a $100 million development milestone in connection with the Company's collaboration with Alnylam Pharmaceuticals, Inc. GAAP and non-GAAP SG&A expenses increased for full year 2024, compared to full year 2023, due to higher commercialization-related expenses to support the Company's launch of EYLEA HD and higher headcount and headcount-related costs partly related to the Company's international commercial expansion. GAAP and non-GAAP COGS increased for full year 2024, compared to full year 2023, primarily due to higher start-up costs for the Company's Rensselaer, New York fill/finish facility. GAAP other operating expense (income), net, for the fourth quarter and full year 2024 reflects charges related to the increase in the estimated fair value of the contingent consideration liability recognized in connection with the Company's 2023 acquisition of Decibel Therapeutics, Inc. Other Financial Information GAAP other income (expense), net included the recognition of net unrealized losses on equity securities of $213 million in the fourth quarter of 2024, compared to $58 million of net unrealized gains in the fourth quarter of 2023. GAAP other income (expense), net included the recognition of net unrealized gains on equity securities of $118 million for full year 2024, compared to net unrealized losses of $238 million for full year 2023. GAAP and non-GAAP other income (expense), net also included interest income of $711 million for full year 2024, compared to $496 million for full year 2023. In the fourth quarter and full year 2024, the Company's GAAP effective tax rate (ETR) was 4.2% and 7.7%, respectively, compared to (1.0%) and 5.9% in the fourth quarter and full year 2023, respectively. The GAAP ETR increased in the fourth quarter of 2024, compared to the same period in the prior year, due to a lower benefit from stock-based compensation. In the fourth quarter and full year 2024, the non-GAAP ETR was 9.9% and 9.6%, respectively, compared to 2.4% and 9.1% in the fourth quarter and full year 2023, respectively. GAAP net income per diluted share was $8.06 in the fourth quarter of 2024, compared to $10.19 in the fourth quarter of 2023. GAAP net income per diluted share was $38.34 for the full year 2024, compared to $34.77 for the full year 2023. Non-GAAP net income per diluted share was $12.07 in the fourth quarter of 2024, compared to $11.86 in the fourth quarter of 2023. Non-GAAP net income per diluted share was $45.62 for the full year 2024, compared to $43.79 for the full year 2023. A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press release. The Company repurchased $976 million and $2.6 billion of shares of its common stock during the fourth quarter and full year 2024, respectively, and recorded the cost of the shares as Treasury Stock. 2025 Financial Guidance(c) 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 fourth quarter and full year 2024 financial and operating results on Tuesday, February 4, 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 Pharmaceuticals, Inc. 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, 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 EYLEA HD® (aflibercept) Injection 8 mg, EYLEA® (aflibercept) Injection, Dupixent® (dupilumab), Libtayo® (cemiplimab), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab), Veopoz® (pozelimab), Ordspono™ (odronextamab), itepekimab, fianlimab, garetosmab, linvoseltamab, Regeneron 's other oncology programs (including its costimulatory bispecific portfolio), REGN5713-5715, nexiguran ziclumeran (nex-z, NTLA-2001), REGN1908-1909, mibavademab, 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; 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); 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 on the commercial success of Regeneron 's Products and Regeneron 's Product Candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; 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 of Regeneron’s Products from third-party payers, including private payer 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 payers and new policies and procedures adopted by such payers; 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 . 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 TABLE 4 TABLE 5 Source: Regeneron Pharmaceuticals, Inc.