Regeneron Pharmaceuticals (REGN) 2025 Conference Transcript

Regeneron Pharmaceuticals (REGN) Conference Call Summary Company Overview - Company: Regeneron Pharmaceuticals (REGN) - Event: Cantor Global Healthcare Conference - Date: September 3, 2025 Key Financial Performance - DUPIXENT: Achieved 21% growth worldwide year-over-year [7] - Libtayo: Recorded 25% growth year-over-year [7] - EYLEA HD: Experienced approximately 29% growth in the US [7] - Overall Revenue Growth: Top line growth at 4%, with EPS increasing by 12% to $12.89 [8] - Share Buybacks: $1.1 billion in Q2 and $2.2 billion in the first half of the year, reducing common shares outstanding by 3.2 million [8] Pipeline Developments - Cemdisiran: Positive data in myasthenia gravis with a 2.3 reduction in the MG ADL scale, positioning it as a competitive option in a $5 billion market [12][13] - Market Growth: The category is expected to double to $10 billion by the end of the decade [13] - Upcoming PDUFA Dates: Anticipated for Libtayo and EYLEA HD, with significant patient populations targeted [9] - Combination Therapies: Cemdisiran plus pozilimab showed promising results, allowing for price discrimination in the market [19] Regulatory and Manufacturing Updates - EYLEA PDUFA Delays: Three-month extension due to third-party manufacturing issues; confidence in resolution and approval remains [25][26] - Investment in R&D: $7 billion allocated to enhance R&D and manufacturing capabilities, including an in-house fill-finish facility expected to be operational in 2026 [29][30] Competitive Landscape - EYLEA Competition: Facing pricing pressures and competition from products like Pavlue and biosimilars [33][35] - DUPIXENT Launch in COPD: Strong initial performance with over 70% of top pulmonologists prescribing the product; significant unmet medical need remains [50][51] - Future Growth: Anticipated continued growth in DUPIXENT across various indications, including chronic spontaneous urticaria and bolas pemphigoid [55][56] Strategic Outlook - Life Post-DUPIXENT: Ongoing investments in the pipeline to ensure revenue generation beyond DUPIXENT's lifecycle, with several INDs expected in the next six to nine months [63][64] - Regulatory Discussions: Plans to engage with regulators regarding the path forward for itepecumab, with clarity expected before year-end [46][47] Conclusion - Regeneron Pharmaceuticals is experiencing strong financial performance driven by key products like DUPIXENT, Libtayo, and EYLEA HD. The company is actively expanding its pipeline and investing in R&D and manufacturing capabilities to sustain growth and navigate competitive pressures in the biopharma landscape.