On Friday, Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) reported second-quarter adjusted earnings of $12.89 per share, up 12% year-over-year, beating the consensus of $8.57.
The company reported sales of $3.68 billion, up 4% year over year, beating the consensus of $3.29 billion.
In the second quarter, U.S. net sales for Eylea HD and Eylea decreased 25% year-over-year to $1.15 billion, including $393 million from Eylea HD and $754 million from Eylea.
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Net product sales of Eylea HD increased in the second quarter of 2025, compared to the second quarter of 2024, due to higher sales volumes driven by increased demand.
Net product sales of EYLEA were negatively impacted by lower sales volumes due to continued competitive pressures, loss in market share to compounded bevacizumab due to patient affordability constraints, continued transition of patients to EYLEA HD, and a lower net selling price.
Sanofi SA (NASDAQ:SNY) collaboration revenue increased, due to the company’s share of profits from the commercialization of antibodies, which were $1.282 billion and $988 million in the second quarter of 2025 and 2024, respectively.
The change in the company’s share of profits from the commercialization of antibodies was driven by higher profits associated with an increase in Dupixent sales.
Pipeline Update
In its earnings press release, Regeneron said it expects regulatory approvals to be delayed for its currently pending U.S. Food and Drug Administration (FDA) applications for EYLEA HD (pre-filled syringe, every-four-week dosing, and for macular edema following retinal vein occlusion), which have PDUFA dates in August 2025.
The anticipated delay concerns observations from an FDA general site inspection at the filler for EYLEA HD in these regulatory applications, Catalent Indiana LLC, recently acquired by Novo Nordisk A/S (NYSE:NVO).
The inspection was completed in mid-July and was not specific to EYLEA HD. Novo has communicated with the FDA and expects to submit its response next week.
Based on the company’s review of the observations, Novo’s proposed response to the FDA, and the progress the company has made with alternate third-party fillers, the company anticipates an expeditious resolution of the filling issues for EYLEA HD.
The FDA issued a Complete Response Letter (CRL) for the application for odronextamab, a bispecific antibody targeting CD20 and CD3, in relapsed/refractory follicular lymphoma after two or more lines of systemic therapy, which was also impacted by the Catalent site inspection.
Outlook
Regeneron expects a 2025 GAAP gross margin of approximately 83%, compared to the prior guidance of 83%–84%.
The company expects an adjusted gross margin of approximately 86%, compared to the prior guidance of 86%–87%.
Price Action: REGN stock is trading higher by 3.77% to $566 premarket at last check Friday.
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