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 10% in afternoon trading.
The drugmaker also announced plans to 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 Indiana filling facility, now owned by Novo Holdings, which led delays in three pending FDA applications for the eye drug Eylea.
Regeneron plans to submit the new filler application by January 2026, with potential FDA approval expected 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.
Amid investor concerns about the inevitable loss of Dupixent exclusivity, CEO Leonard Schleifer said there is “no allergy” to doing large deals, which Oppenheimer analysts described as a positive “posture change”.
Sales of the 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’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.
It 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)
