Hims & Hers Health says it will offer compounded GLP-1 drugs, despite FDA warnings

By Eleanor Laise

Price of injectable weight-loss drug to start at $199 per month; stock jumps nearly 30%

Hims & Hers Health Inc.'s stock (HIMS) jumped nearly 30% on Monday after the health and wellness platform said it would offer compounded GLP-1 drugs - products that the Food and Drug Administration has warned against.

The company said Monday that it will offer compounded GLP-1 drugs with the same active ingredient as Novo Nordisk's (NVO) diabetes drug Ozempic and weight-loss treatment Wegovy, saying the products would let customers sidestep "the shortages and costs that are currently limiting access to the branded medications."

The FDA said in January that it has received adverse-event reports after patients used compounded semaglutide, the active ingredient in Ozempic and Wegovy. "Patients should not use a compounded drug if an approved drug is available to treat a patient," the agency said, adding that it does not review compounded versions of these drugs for safety, effectiveness or quality.

Several dosages of Wegovy currently have limited availability, according to the FDA's drug-shortages database. Ozempic is not approved for weight management. Amid surging demand, both Novo Nordisk and Eli Lilly & Co. (LLY), maker of weight-loss drug Zepbound, have invested heavily in expanding their manufacturing capacity.

Hims & Hers Health said it is working with a manufacturer of compounded injectable drugs that is registered with the FDA as a 503B outsourcing facility, meaning it must comply with the agency's current requirements for good manufacturing practices. Hims & Hers Health researched 503B pharmacies for over a year, "putting rigorous standards in place for vetting" before choosing a supplier, company CEO Andrew Dudum said in a blog post Monday.

The company also said it plans to offer customers branded GLP-1 drugs once a consistent supply is available through its affiliated pharmacies' wholesaler.

Hims & Hers Health is also offering oral weight-management medication kits. Prices start at $79 per month for the oral medication kits and $199 per month for the compounded GLP-1 drugs. Those prices include unlimited medical consultations with a licensed provider, the company said.

The company said its weight-loss offering is on track to surpass $100 million in revenue by the end of 2025, although the current guidance does not reflect the addition of GLP-1 drugs to the platform, and Hims & Hers is not updating guidance at this point.

Hims & Hers stock soared 28% Monday. The shares are up 109% in the year to date, while the S&P 500 SPX has climbed 11%.

-Eleanor Laise

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05-20-24 2001ET

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