Shares of Hims & Hers Health tumbled greater than 23% on Friday after the U.S. Food and Drug Administration announced that the shortage of semaglutide injection products has been resolved.
Semaglutide is the energetic ingredient in Novo Nordisk’s blockbuster weight reduction drug Wegovy and diabetes treatment Ozempic. Those medications are a part of a category of medicine called GLP-1s, and demand for the treatments has exploded lately. Consequently, digital health firms resembling Hims & Hers have been prescribing compounded semaglutide in its place for patients who’re navigating volatile supply hurdles and insurance obstacles.
Compounded drugs are custom-made alternatives to brand-name drugs designed to fulfill a selected patient’s needs, and compounders are allowed to supply them when brand-name treatments are in shortage. The FDA doesn’t review the protection and efficacy of compounded products.
Hims & Hers began offering compounded semaglutide to patients in May, and it owns compounding pharmacies that produce the medications.
Compounded medications are typically less expensive than their branded counterparts. Hims & Hers sells compounded semaglutide for lower than $200 monthly, while Ozempic and Wegovy each cost around $1,000 monthly without insurance.
The FDA said Friday that it would start taking motion against compounders for violations in the following 60 to 90 days, depending on the variety of facility, to be able to “avoid unnecessary disruption to patient treatment.”
“Now that the FDA has determined the drug shortage for semaglutide has been resolved, we are going to proceed to supply access to personalized treatments as allowed by law to fulfill patient needs,” Hims & Hers CEO Andrew Dudum posted Friday on X. “We’re also closely monitoring potential future shortages, as Novo Nordisk stated two weeks ago that it will proceed to have ‘capability limitations’ and ‘expected continued periodic supply constraints and related drug shortage notifications.'”
Him & Hers’ weight reduction offerings have been a large hit with investors. Shares of the corporate climbed greater than 200% last yr, and the stock is already up greater than 100% this yr despite Friday’s move.
Even before it added compounded GLP-1s to its portfolio, the corporate said in its 2023 fourth-quarter earnings call that it expects its weight reduction program to usher in greater than $100 million in revenue by the top of 2025.
Despite the turbulent regulatory landscape, Hims & Hers has showed no signs of slowing down.
On Friday, the corporate announced it has acquired a U.S.-based peptide facility that can “further verticalize the corporate’s long-term ability to deliver personalized medications.” Hims & Hers will explore advances across metabolic optimization, recovery science, biological resistances, cognitive performance and preventative health through the acquisition, the company said.
That move comes just days after Hims & Hers also bought Trybe Labs, the Recent Jersey-based at-home lab testing facility. Trybe Labs will allow Hims & Hers to perform at-home blood draws and more comprehensive pretreatment testing.
Hims & Hers didn’t disclose the terms of either deal.
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