8-K: Regeneron Highlights Pipeline Progress and Business Updates at J.P. Morgan Healthcare Conference

Regeneron shares corporate progress and highlights from its broad and diverse investigational pipeline at the annual J.P. Morgan Healthcare Conference.

Summary

• Regeneron presented business updates and pipeline highlights at the J.P. Morgan Healthcare Conference on January 13, 2025.
• Dupixent is now used to treat over a million patients globally and has potential for further growth in existing and additional indications.
• EYLEA HD and EYLEA remained the U.S. anti-VEGF category leader in 2024, with aggregate U.S. net product sales of $6 billion, up 1%.
• An EYLEA HD pre-filled syringe (PFS) submission has been completed, with a launch expected by mid-2025.
• Libtayo exceeded $1 billion in annual net sales in 2024 and demonstrated a statistically significant clinical benefit as adjuvant therapy in high-risk cutaneous squamous cell carcinoma (CSCC).
• The linvoseltamab BLA has been resubmitted following resolution of third-party manufacturing issues, with launch anticipated in mid-2025.
• Regeneron has approximately 40 investigational candidates in its pipeline, covering dozens of disease states with expansive market potential.
• The company is collaborating with Truveta to expand its DNA-linked healthcare database.
• The company's therapeutic candidates tackle a myriad of diseases, with the most advanced programs addressing an aggregate commercial market opportunity expected to exceed $220 billion by 2030.

Sentiment

Score: 8

Explanation: The document presents a positive outlook for Regeneron, highlighting strong performance of key products, pipeline advancements, and strategic collaborations. While there are risks and uncertainties associated with forward-looking statements, the overall tone is optimistic and confident.

Positives

• Dupixent's continued growth and expansion in multiple Type 2 indications.
• EYLEA HD and EYLEA's leadership in the U.S. anti-VEGF category.
• Libtayo's achievement of blockbuster status and clinical benefit in adjuvant CSCC.
• Advancement of linvoseltamab with potential to be a best-in-class BCMA bispecific.
• Progress in the DNA sequence-linked healthcare database through collaboration with Truveta.
• The potential for the company's therapeutic candidates to address a commercial market opportunity expected to exceed $220 billion by 2030.

Negatives

• The acquired in-process research and development (IPR&D) charge of approximately $14 million on a pre-tax basis is expected to negatively impact each of GAAP and non-GAAP net income per diluted share for the fourth quarter 2024 by approximately $0.11.
• There can be no assurance that actual results will not differ from the preliminary (unaudited) estimates described or incorporated by reference herein.

Risks

• The company's financial results for the fourth quarter and full year 2024 have not been finalized and are subject to Regeneron's financial statement closing procedures.
• There is no assurance that actual results will not differ from the preliminary estimates.
• Forward-looking statements involve risks and uncertainties, and actual events or results may differ materially.
• The success of commercializing marketed products and product candidates is subject to competitive and other relevant developments.
• The ability of collaborators, licensees, suppliers, or other third parties to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates.
• 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.
• 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.
• 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 (such as those that may result from the strategic collaboration with Truveta, Inc. discussed in this press release) may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval.
• The potential for any license, collaboration, or supply agreement, including Regeneron's agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), as well as the collaboration with Truveta, Inc. discussed in this press release, to be cancelled or terminated.
• The impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on Regeneron's business.
• 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), other 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), 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.

Future Outlook

Regeneron anticipates continued growth and expansion of its marketed products and advancement of its pipeline, with numerous milestones expected in 2025 and beyond. The company is focused on genetics-driven drug discovery and expanding its DNA sequence-linked healthcare database.

Management Comments

• The Regeneron name is synonymous with innovation, brought to life through proprietary technologies and world-class science that produce medicines that make a meaningful impact on patients lives, said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron.
• Thanks to our long-term and consistent R&D investment, we have in addition to our four blockbuster medicines one of the industrys largest, most promising and most diverse clinical pipelines.
• Our therapeutic candidates tackle a myriad of diseases, with the most advanced programs addressing an aggregate commercial market opportunity expected to exceed $220 billion by 2030.
• We are well positioned for future growth and more confident than ever in the power of Regenerons science.
• Regeneron continues to diversify our commercial, clinical and research portfolios by relentlessly pushing the boundaries of innovation and technology, said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer of Regeneron.
• In 2025, we will progress dozens of promising new assets and expand the reach of our important established medicines to help even more patients in need.
• We remain at the forefront of biotechnologys most remarkable era of drug discovery, striving to change the practice of medicine with approaches spanning antibodies, bispecifics, gene editing, gene silencing, gene therapy and cell therapy supported by DNA sequenceand proteomics-linked healthcare database.

Industry Context

Regeneron's presentation at the J.P. Morgan Healthcare Conference highlights its position as a leading biotechnology company with a diverse portfolio of marketed products and a robust pipeline. The company's focus on innovation, genetics-driven drug discovery, and strategic collaborations positions it well to compete in the evolving pharmaceutical landscape.

Comparison to Industry Standards

• Libtayo is the first and only immunotherapy to show a statistically significant disease-free survival benefit in high-risk CSCC in the adjuvant setting, while a recent Phase 3 trial with Keytruda failed in the same setting.
• Linvoseltamab has the potential to be the best-in-class BCMAxCD3 bispecific with its differentiated clinical profile, dosing regimen and administration method.
• Regeneron's Genetics Center has created the world's largest DNA sequence-linked healthcare database, surpassing other industry efforts in scale and scope.
• The company's pipeline includes programs addressing a commercial market opportunity expected to exceed $220 billion by 2030, demonstrating a significant growth potential compared to many of its peers.

Stakeholder Impact

• Shareholders: The document provides updates on the company's performance and future prospects, which may influence investment decisions.
• Patients: The document highlights the development of new medicines and potential treatments for various diseases, offering hope for improved health outcomes.
• Employees: The document showcases the company's innovation and growth, which may impact job security and career opportunities.
• Customers: The document provides information on the company's marketed products and their benefits, which may influence purchasing decisions.
• Suppliers: The document outlines the company's manufacturing and supply chain activities, which may impact business relationships.
• Creditors: The document provides financial information that may influence lending decisions.

Next Steps

• Submit a sBLA for EYLEA HD for every four-week dosing and for retinal vein occlusion (RVO) in the first quarter of 2025.
• Present detailed results of the Libtayo adjuvant CSCC trial at an upcoming medical meeting and share with regulatory authorities, with a plan for FDA submission in the first half of 2025.
• Report results from the Phase 3 AERIFY study of itepekimab in COPD in the second half of 2025, with a potential BLA submission to follow.
• Report results from the first Phase 3 study of fianlimab for melanoma in the second half of 2025, with a potential BLA submission to follow.
• Initiate pivotal trials for REGN7508 and REGN9933 (Factor XI antibodies) in 2025.
• Report initial data from Phase 2 studies of trevogrumab and semaglutide with and without garetosmab, and tirzepatide and mibavademab in obesity in the second half of 2025.
• Report Phase 3 results for C5 Combo (pozelimab and cemdisiran) in generalized myasthenia gravis in the second half of 2025.
• Report additional data for DB-OTO in mid-2025.

Key Dates