Regeneron tops quarterly estimates, plans to resubmit Eylea application
By Christy Santhosh
(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 shares up 8%.
The drugmaker said it will resubmit the marketing application for the pre-filled syringe version of higher-dose Eylea, or Eylea HD, after the U.S. Food and Drug Administration declined its approval on Monday.
The company has been facing multiple regulatory setbacks due to the issues at Catalent's Bloomington filling facility, which caused a delay for three pending applications of eye drug Eylea with the FDA.
"We recognize that it would be more ideal if we could have our own filling. We would have expected to have that by now, but we got delayed dramatically during COVID," CEO Leonard Schleifer said.
Regeneron plans to submit the new filler application by January 2026, which could receive FDA approval by mid 2026, according to multiple analysts.
"The third-quarter update offered more detailed and potentially sooner de-risking of the new filler for Eylea HD than most investors anticipated" Cantor analyst Carter Gould said.
Regeneron has been trying to move its customer base to higher-dose Eylea, which allows longer intervals between injections for patients.
The company'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.Sales of its top-selling anti-inflammatory drug, Dupixent, made jointly with French drugmaker Sanofi, rose 27% to $4.86 billion, compared with an estimate of $4.54 billion.
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.
(Reporting by Christy Santhosh in Bengaluru; Editing by Shreya Biswas)
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