The company said total revenues for Q3 2025 rose to $3,754 million from $3,721 million a year earlier, up 1%, and that GAAP net income was $1,460 million and GAAP diluted earnings per share were $13.62.

1. 01

   The company said total revenues for Q3 2025 rose to $3,754 million from $3,721 million a year earlier, up 1%, and that GAAP net income was $1,460 million and GAAP diluted earnings per share were $13.62.

2. 02

   The company said U.S. net sales of EYLEA HD rose 10% to $431 million in Q3, while U.S. net sales of EYLEA fell 41% to $681 million, so combined U.S. net sales of EYLEA HD and EYLEA decreased 28% to $1,112 million.

3. 03

   Regeneron said Sanofi collaboration revenue rose 28% to $1,617 million in Q3, which it attributed to a higher share of profits from antibody commercialization, up to $1.46 billion. It said global net sales of Dupixent, as recorded by Sanofi, were $4.86 billion.

4. 04

   Regeneron said Catalent Indiana, LLC, the filler for the EYLEA HD BLA, notified it that Catalent had received an FDA Official Action Indicated letter. It said the FDA issued a Complete Response Letter for the EYLEA HD pre-filled syringe sBLA and that the company plans to submit an application adding a new pre-filled syringe filler by January 2026.

Analysis scope · Filing body and confirmed press-release exhibitWe analyzed the filing body and confirmed exhibits. This is not a review of other exhibits, investor presentations or the full earnings call.

AI summarized the filing and translated the summary into English; it may differ from the original. For reference only, not investment advice. AI translated the published Korean report into English. Figures are copied as filed, not recalculated.

Original filing

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