Regeneron beats quarterly estimates on strong demand for Dupixent

(Reuters) -Regeneron Pharmaceuticals beat Wall Street estimates for third-quarter results on Tuesday, helped by strong demand for its eczema treatment, Dupixent, and cancer treatment Libtayo, sending its shares up 5.6% premarket.

Analysts said Dupixent, made by the U.S. drugmaker in partnership with Sanofi, continues to impress, after the drug topped quarterly sales expectations when the French company reported its results last week.

Meanwhile, Regeneron's eye disease drug, Eylea, has been facing stiff competition from cheaper versions and rivals such as Roche's Vabysmo.

The company is trying to move its customer base to a newer formulation of Eylea with a higher dosage, or Eylea HD, which allows longer intervals between injections for patients.

Regeneron said the U.S. Food and Drug Administration had declined to approve Eylea HD's pre-filled syringe version on Monday, citing issues related to unresolved inspection findings at the Catalent facility in Bloomington, Indiana.

The company is currently facing multiple regulatory setbacks due to the issues at the Catalent facility, which Novo Nordisk acquired in late 2024.

Regeneron said it is planning to submit a new filler application by January 2026 for Eylea HD, which could receive FDA approval by April or May, according to Raymond James analysts.

Analysts see the Eylea franchise as stable, but do not expect it to grow significantly until Regeneron attains key label and format extensions, which may be delayed into 2026.

Regeneron's total revenue came in at $3.75 billion for the third quarter, beating analysts' average estimate of $3.59 billion, according to data compiled by LSEG.U.S. sales of the 8-milligram high-dose version of Eylea, jointly developed with Bayer AG, rose 10% to $431 million from a year ago.Regeneron's skin cancer treatment, Libtayo, brought in sales of $365 million, above estimates of $343.75 million.

The company earned a quarterly profit of $11.83 per share on an adjusted basis, compared with expectations of $9.59.

($1 = 0.7931 Swiss francs)

(Reporting by Christy Santhosh in Bengaluru; Editing by Shreya Biswas)

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