Regeneron Reports Third Quarter 2025 Financial and Operating Results

Core Insights - Regeneron Pharmaceuticals reported solid financial results for Q3 2025, with total revenues increasing by 1% to $3.75 billion compared to Q3 2024, and GAAP net income rising by 9% to $1.46 billion [3][5][13]. Financial Highlights - Total revenues for Q3 2025 were $3,754 million, up from $3,721 million in Q3 2024, reflecting a 1% increase [3][13]. - GAAP net income reached $1,460 million, a 9% increase from $1,341 million in the same quarter last year [3][13]. - GAAP diluted net income per share was $13.62, an 18% increase from $11.54 in Q3 2024 [3][13]. - Non-GAAP net income decreased by 12% to $1,287 million, with non-GAAP diluted net income per share at $11.83, down 5% from $12.46 [3][13]. Business Highlights - Regeneron made significant progress in its late-stage portfolio, securing new FDA approvals for Libtayo, Evkeeza, and Lynozyfic, and receiving positive CHMP opinions for Libtayo and Dupixent [2][4]. - Dupixent global net sales increased by 27% to $4.86 billion, while EYLEA HD U.S. net sales rose by 10% to $431 million [5][13]. - The company has approximately 45 product candidates in clinical development, with notable updates including positive Phase 3 results for various therapies [4][10]. Pipeline Progress - Dupixent received a positive opinion from the EMA for treating chronic spontaneous urticaria in adults and adolescents [4]. - Libtayo was approved by the FDA as the first immunotherapy for high-risk adjuvant cutaneous squamous cell carcinoma [10]. - Positive Phase 3 results were reported for treatments in generalized myasthenia gravis and fibrodysplasia ossificans progressiva [10][11]. Capital Allocation - In the first nine months of 2025, Regeneron invested nearly $5 billion in R&D and capital expenditures, primarily in the U.S. [3][24]. - The company returned over $3 billion to shareholders through share repurchases and dividends, emphasizing its commitment to long-term value creation [3][24]. Corporate Updates - Regeneron resolved patent infringement litigation related to EYLEA biosimilars, preventing competitors from launching their products until Q4 2026 [12]. - The company plans to submit applications for new manufacturing fillers for EYLEA HD by January 2026 [6][7].