Regeneron Pharmaceuticals Inc ( REGN ). on Tuesday reported third-quarter adjusted earnings of $11.83 per share, down 5% year-over-year, beating the consensus of $9.59.

The company reported sales of $3.75 billion, up 1% year over year, beating the consensus of $3.59 billion.

In the quarter, U.S. net sales for Eylea HD and Eylea decreased 28% year-over-year to $1.12 billion, including $431 million from Eylea HD and $681 million from Eylea.

Eylea HD sales increased due to higher volumes, driven by stronger demand, partly offset by a lower net selling price. Lower volumes negatively impacted Eylea sales due to competitive pressures, a loss of market share to compounded bevacizumab driven by patient affordability constraints, and the continued transition of patients to Eylea HD and a lower net selling price.

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Sanofi SA ( SNY ) collaboration revenue increased 28% to $1.62 billion, driven by an increase in the company’s share of profits from the commercialization of antibodies, which were $1.46 billion and $1.09 billion in the third quarter of 2025 and 2024, respectively.

The change in the company’s share of profits from the commercialization of antibodies was driven by higher earnings from increased Dupixent sales.

Pipeline Update

In its earnings press release, Regeneron said Monday, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the prefilled syringe supplemental BLA (sBLA).

The sole approvability issue cited in the CRL relates to unresolved inspection findings at Catalent. The company plans to submit an application by January 2026 to include a new prefilled syringe manufacturing filler in the Eylea HD BLA.

Regeneron said a supplement application is under FDA review for EYLEA HD every-four-week dosing and for macular edema following retinal vein occlusion, with a target action date in late November 2025.

In addition, the company has applied to include an additional vial filler, with an FDA decision regarding this new vial filler expected by late December 2025.

Outlook

Regeneron expects a 2025 GAAP gross margin of approximately 82%, compared to the prior guidance of approximately 83%.

The company reaffirms its adjusted gross margin of approximately 86%.

Price Action: REGN stock is up 3.96% to $608.50 in the premarket at the last check on Tuesday.

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