By Mariam Sunny
(Reuters) -Regeneron’s first-quarter results missed Wall Street estimates on Tuesday due to stiff competition for its blockbuster drug Eylea, further stoking investor worries as U.S. regulators denied approval for a more convenient version of the eye therapy.
Shares of Regeneron were down nearly 8%.
Regeneron has been looking to switch patients to a higher-dose version of the drug, branded as Eylea HD, to stymie the loss in market share to cheaper versions and rivals.
The U.S. Food and Drug Administration declined to approve a pre-filled syringe version of Eylea HD last week citing issues with a third-party supplier.
The FDA has committed to a speedy review of the additional data submitted by the supplier, Regeneron said, adding the regulator did not flag any issues with the drug’s safety or efficacy.
Regeneron does not expect any material impact from U.S. President Donald Trump’s sweeping tariffs implemented to date and said it could not quantify the impact from potential sector-specific tariffs at this time.
Drugmakers, including Regeneron, have committed to additional investments to boost production in the U.S. amid concerns about healthcare funding cuts and mass layoffs at the FDA.
“Obviously experience does matter and I really hope that we do not lose really good people at the FDA in the rank and file or even at the policy level. I think that would be deleterious,” Regeneron CEO Leonard Schleifer said.
Regeneron earned quarterly profit of $8.22 per share, below estimates of $8.82 according to data compiled by LSEG.
U.S. sales of Eylea, jointly developed with Bayer, fell 26% in the first quarter to $1.04 billion.
First-quarter revenue was $3.03 billion, below expectations of $3.27 billion.
Sales of anti-inflammatory drug Dupixent, made jointly with France’s Sanofi, rose 19% to $3.67 billion, compared with estimates of $3.7 billion. Sanofi records Dupixent sales, and profits are split equally between the two companies.
(Reporting by Mariam Sunny in Bengaluru; Editing by Krishna Chandra Eluri)
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