Regeneron reports preliminary Q4 Eylea HD U.S. net product sales of $305M

Regeneron (REGN) Pharmaceuticals announced it will share corporate progress and highlights from the company’s investigational pipeline while presenting at the annual J.P. Morgan Healthcare Conference at 5:15 p.m. Eastern Time. Ahead of that presentation, Leonard Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron, stated: “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. Thanks to our long-term and consistent R&D investment, we have – in addition to our four blockbuster medicines – one of the industry’s 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 $220B by 2030. We are well positioned for future growth and more confident than ever in the power of Regeneron’s science.” The company added: “On a combined basis, Eylea HD Injection 8 mg and Eylea Injection 2 mg remained the U.S. anti-VEGF category leader in 2024. Based on preliminary unaudited results, the products achieved 1% year-over-year growth by reaching $6B in aggregate U.S. net product sales for the year and $1.5B in aggregate U.S. net product sales for the fourth quarter of 2024, despite increasing competition. Eylea HD U.S. net product sales were $305M in the fourth quarter of 2024. EYLEA U.S. net product sales were $1.19 billion in the fourth quarter of 2024. Combined Eylea HD and Eylea U.S. net product sales for the fourth quarter of 2024 were favorably impacted by approximately $85M as a result of higher wholesaler inventory levels for Eylea, partially offset by lower wholesaler inventory levels for Eylea HD. The company filed an application with the FDA for use of the Eylea HD pre-filled syringe with U.S. approval and launch expected by mid-2025. Longer term data in wet age-related macular degeneration and diabetic macular edema are under FDA review with a PDUFA date of April 20, 2025 to potentially extend dosing intervals for Eylea HD up to every-24 weeks. The company plans to submit a sBLA for Eylea HD for every four-week dosing and for retinal vein occlusion in the first quarter of 2025 to potentially maximize dosing flexibility and address more retinal diseases. Libtayo exceeded $1B in sales for 2024 and remains foundational to Regeneron’s oncology portfolio.”