Regeneron Pharmaceuticals FY Conference Summary Company Overview - Company: Regeneron Pharmaceuticals (NasdaqGS:REGN) - Date of Conference: December 02, 2025 Key Accomplishments in 2025 - Eylea HD: Significant growth noted, with recent label enhancements for Q4 weekly dosing and RVO indication expected to drive future uptake. The RVO indication represents about 20% of the overall market and 17-18% of Eylea's business [6][7][17] - Dupixent: Expanded to eight indications in the U.S., with strong international performance. Recent approvals include COPD, bullous pemphigoid, and CSU, with a total potential patient population of approximately 927,000 [7][11][39] - Libtayo: Successful label expansion for adjuvant CSCC, with positive reception from the KOL community. The launch is progressing well, with a focus on early treatment paradigms [8][50] - Linvoseltamab: Launched for advanced treatment indications, showing early interest and uptake in the community [9][53] - Ultra-Rare Disease Portfolio: Continued advancements in the ultra-rare disease space, including Evkeeza for HoFH [10] Pipeline and Future Developments - Immunology: Positive data for Dupixent in allergic fungal rhinosinusitis, with a PDUFA date in February. Ongoing expansion in various indications [11][12] - Neurology: Cemdisiran for generalized myasthenia gravis shows potential in a $5 billion market, expected to double by 2030 [67][68] - Oncology: Libtayo's adjuvant CSCC indication is expected to have a gradual uptake, with significant investment in marketing to relevant medical professionals [50][51] - Ophthalmology: Eylea HD is positioned strongly against competitors, with ongoing development of new therapies targeting glaucoma and other conditions [35][36] Financial Highlights - Capital Allocation: Initiated a dividend with a modest yield, returning approximately $4 billion through dividends and share repurchases in 2025. Increased share repurchase from $2.6 billion in 2024 to an anticipated $3.6 billion in 2025 [13][14] - Investment in U.S. Manufacturing: Committed over $7 billion to enhance manufacturing and research capabilities in the U.S. [14] Market Dynamics and Competitive Landscape - Biosimilars Impact: Eylea's business has shifted towards Eylea HD, with some episodic uptake of biosimilars. The market is complicated by affordability issues, impacting brand selection [26][28] - Next-Gen Products: Regeneron is monitoring competition from bispecifics and multispecifics but remains confident in Eylea HD's competitive profile [30][34] Lifecycle Management and Future Strategies - Dupixent Lifecycle Management: Exploring ways to extend dosing intervals and develop adjacent pathways, with a broad pipeline of over 45 clinical candidates [44][46] - Business Development: Active in seeking collaborations and partnerships, including a recent $150 million deal with Tessera for gene editing opportunities [75] Conclusion - Regeneron Pharmaceuticals has had a productive year in 2025, with significant advancements in product performance, pipeline development, and capital allocation. The company is well-positioned for continued growth in 2026, focusing on optimizing existing products and advancing innovative therapies across various therapeutic areas [78][80]
Regeneron Pharmaceuticals (NasdaqGS:REGN) FY Conference Transcript