Core Insights - Regeneron Pharmaceuticals reported third-quarter adjusted earnings of $11.83 per share, a 5% decrease year-over-year, surpassing the consensus estimate of $9.59 [1] - The company achieved sales of $3.75 billion, reflecting a 1% year-over-year increase and exceeding the consensus of $3.59 billion [1] - U.S. net sales for Eylea HD and Eylea fell 28% year-over-year to $1.12 billion, with Eylea HD contributing $431 million and Eylea contributing $681 million [1] Sales Performance - Eylea HD sales increased due to higher volumes driven by stronger demand, although this was partially offset by a lower net selling price [2] - Eylea sales were negatively impacted by lower volumes due to competitive pressures, market share loss to compounded bevacizumab, and patient transitions to Eylea HD [2] Collaboration Revenue - Sanofi collaboration revenue rose 28% to $1.62 billion, primarily due to increased profits from antibody commercialization, which amounted to $1.46 billion in Q3 2025 compared to $1.09 billion in Q3 2024 [3] Pipeline Developments - The FDA issued a Complete Response Letter (CRL) for the prefilled syringe supplemental BLA, citing unresolved inspection findings at Catalent [4] - Regeneron plans to submit an application by January 2026 to include a new prefilled syringe manufacturing filler in the Eylea HD BLA [4] - A supplement application is under FDA review for EYLEA HD every-four-week dosing, with a target action date in late November 2025 [5] Financial Outlook - Regeneron expects a 2025 GAAP gross margin of approximately 82%, down from prior guidance of 83%, while reaffirming an adjusted gross margin of approximately 86% [6] - REGN stock rose 3.96% to $608.50 in premarket trading [6]
Regeneron's Q3 Earnings Outperform Expectations With Dupixent Strength Balancing Eylea Weakness