By Sneha S K
(Reuters) -Hims & Hers said on Monday that it may no longer be able to sell compounded versions of the weight-loss drug made by Novo Nordisk because its pathway to do so closed when the U.S. FDA declared Friday that the drug’s shortage was over.
The company’s shares fell 19.4% to $41.41 after market.
Compounding pharmacies have been able to make legal copies of Novo’s Wegovy while the drug was in shortage. On Friday, the Food and Drug Administration said that it had removed the drug from its shortage list and gave compounders 60-90 days to stop making copies of the still patented drug.
Hims & Hers, a telehealth firm, had been selling these copies from compounders for far less than Novo’s Wegovy and also had a ready supply.
Hims & Hers in a regulatory filing said while it believes there are paths to continue offering access to certain compounded GLP-1s after the shortage ends, it cannot “guarantee that we will be able to continue offering these products in the same manner, to the same extent, or at all.”
The company has been positioning itself to continue to sell compounded semaglutide using personalized doses after the shortage officially ended, according to a research note published on Friday by Leerink Partners analyst Michael Cherny.
“It is now critical to understand its legal pathway to selling personalized doses since it has to be the primary mechanism to sell semaglutide going forward,” Cherny said in the note.
Drug compounders sued the FDA on Monday, saying that the agency’s finding of no longer being a shortage of the drugs’ active ingredient, semaglutide, was arbitrary and capricious.
Americans who cannot afford Wegovy or have struggled to find it have been turning to cheaper versions sold by compounding pharmacies and telehealth providers such as Hims & Hers and WeightWatchers. Wegovy has been shown to help patients lose as much as 15% of their weight on average.
The copies are not FDA approved, although the FDA and states do have some oversight of these pharmacies.
The company also reported fourth-quarter revenue of $481.1 million, compared with the average analyst estimate of $470.3 million, according to data compiled by LSEG.
Hims & Hers warned that the price of the compounded versions may increase significantly, which could cause existing customers to cancel their subscriptions and decrease new customer demand.
(Reporting by Sneha S K in Bengaluru; Editing by Shounak Dasgupta and Alan Barona)
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