Overview
- Revenue reached $3.75 billion and adjusted EPS was $11.83, both ahead of Wall Street expectations.
- Dupixent sales rose 27% to $4.86 billion and Libtayo generated $365 million, exceeding analyst estimates.
- U.S. net sales for Eylea and Eylea HD fell 28% to $1.12 billion, with Eylea HD up 10% to $431 million as the franchise contends with Roche’s Vabysmo and compounded bevacizumab.
- The FDA issued a Complete Response Letter for the Eylea HD prefilled-syringe filing citing Catalent inspection findings, and Regeneron plans to file for a new prefilled-syringe filler by January 2026.
- Regeneron expects FDA decisions in late November 2025 on Eylea HD dosing and retinal vein occlusion and in late December 2025 on an added vial filler, and it now guides to ~82% 2025 GAAP gross margin while reaffirming ~86% adjusted.