Regeneron Pharmaceuticals, Inc. (REGN) Goldman Sachs 45th Annual Global Healthcare Conference (Transcript)

Regeneron Pharmaceuticals, Inc. Conference Call Summary Company Overview - Company: Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) - Event: Goldman Sachs 45th Annual Global Healthcare Conference - Date: June 11, 2024 Key Points Capital Allocation Strategy - Regeneron's capital allocation strategy is based on three pillars: 1. Investment in internal R&D capabilities, which is considered the best long-term value for shareholders [6] 2. Investment in manufacturing capabilities, including a recent investment in a fill package and labeling facility in Rensselaer, New York [6] 3. Returning capital to shareholders through share buybacks, with over $12 billion spent since the program began and an additional $3 billion authorized for buybacks [8] Development Balance with Sanofi - As of the first quarter, the development balance with Sanofi was $2.2 billion, expected to be fully reimbursed by the end of 2026, potentially adding $600 million to $800 million in profitability for Regeneron [10][11] EYLEA HD Product Update - EYLEA HD received a permanent J-code from CMS, streamlining reimbursement and increasing physician confidence in prescribing [14] - The product is seeing a steady increase in prescribing, with a significant portion of patients switching from EYLEA and other treatments [17][18] - Over 80% of lives are covered for EYLEA HD, indicating strong market penetration [19] Legal Matters - Regeneron is involved in litigation to protect its aflibercept formulation patent, with a recent favorable ruling in December 2023 [21] - The company is seeking injunctions against biosimilar applicants to prevent market entry until patent expiration in June 2027 [22] Dupixent Update - The FDA extended the PDUFA date for Dupixent in COPD due to additional analyses requested, but Regeneron remains confident in its approvability [24][25] - The patent portfolio for Dupixent is robust, with ongoing preclinical activities to extend treatment duration and explore biobetters [27] Pipeline Developments - Upcoming data releases include: - PDUFA date for linvoseltamab in August 2024 - Libtayo adjuvant CSCC data by the end of 2024 - Phase 3 melanoma data expected in 2025 [29][30] - Regeneron is also exploring obesity treatments with promising early data from Phase 1 studies [33][35] Allergy and Oncology Programs - Initial data from a combination study of linvoseltamab and Dupixent in severe food allergies is expected by the end of 2024 [42] - The oncology portfolio is highlighted by the fianlimab program, with lung data anticipated by the end of 2024 [46] M&A and Dividend Considerations - Regeneron has $17.5 billion in cash, providing flexibility for potential M&A opportunities, though no immediate plans are in place [57] - The company is evaluating the possibility of issuing dividends but has not committed to any at this time [58] Additional Insights - Regeneron is focused on innovative R&D across various therapeutic areas, including oncology, genetic medicines, and inflammation [54] - The company is optimistic about its pipeline and the potential for new treatments to address unmet medical needs [55]