Regeneron Pharmaceuticals (NASDAQ:REGN) on Friday topped Street forecasts with its Q2 financials, thanks mainly to U.S. sales for its newly developed high-dose version of its blockbuster eye care therapy Eylea, marketed with Bayer (OTCPK:BAYZF).
The Tarrytown, New York-based pharma giant recorded $3.7B in revenue for the quarter, exceeding the consensus by $400M even as sales from its standard Eylea therapy plunged ~39% to $754M in the U.S. amid competitive headwinds.
However, Eylea HD sales surged ~29% YoY to $393M thanks to higher sales volumes driven by increased uptake, while total Eylea sales fell ~25% YoY to $1.1B in the U.S.
Globally, Eylea HD sales reached $634.9M with ~78% YoY growth, and Eylea sales fell ~28% YoY to $1.5B while REGN’s skin cancer therapy Libtayo added $376.5M to the topline with ~27% YoY growth.
“Regeneron had a strong quarter, marked by significant growth in U.S. sales of EYLEA HD and global sales of Dupixent and Libtayo, along with multiple regulatory approvals,” CEO Leonard Schleifer remarked.
Meanwhile, REGN’s collaboration revenue climbed ~22% YoY to $1.9B, driven by its Sanofi (SNY) collaboration, which added $1.4B to the topline with ~26% YoY growth, mainly due to higher profits attributed to increased sales for its asthma therapy Dupixent, marketed with the French company.
For the bottom line, the company recorded $12.89 of non-GAAP earnings per share, exceeding the consensus by $4.46 while its non-GAAP gross margin reached ~86% compared to ~89% in the prior period.
Looking ahead, Regeneron (NASDAQ:REGN) projects nearly 83% of non-GAAP gross margin for 2025 compared to its prior forecast of 86%–87%.
As for regulatory updates, the company said it expects delays for decisions related to its marketing applications for Eylea HD pre-filled syringe and for macular edema following retinal vein occlusion, which are currently pending at the FDA with a target action date in August.
Regeneron (NASDAQ:REGN) attributed the delay to issues found during an FDA site inspection at a contract manufacturing site operated by Catalent, which was acquired by Novo Nordisk (NVO) recently.