The boom in numbers
Hims & Hers closed 2024 with $1.48 billion in revenue (+69% YoY) and 2.2 million active subscribers. The company doesn't break out GLP-1 in the official report, but analysts (Citi, Goldman Sachs) estimate 30-40% of absolute growth came from compounded semaglutide and tirzepatide.
The pivot
Faced with the May 22, 2025 FDA deadline for semaglutide, Hims announced in its Q4 that it would pivot to 'personalized compounds' — defined as mixes adding ingredients (vitamin B12, glycine, naltrexone) or individualized dose tweaks to the base semaglutide, which in theory keeps them outside the § 503A exclusionary umbrella.
Legal risk
Eli Lilly sued Hims & Hers on April 23, 2025 alleging 'mass production disguised as personalization'. The FDA issued a generic warning letter to large compounding pharmacies stating that 'personalized compounds' that don't respond to a documented clinical need of the individual patient are not legitimate under § 503A.
What this says about the market
The era of compounded GLP-1 at $200-300/month is ending. Three paths remain in the US: official brands (stable or slightly lower pricing via Lilly Direct/NovoCare), personalized compounding under increasing legal risk, and 'research use only' vials that live in a gray zone but keep seeing rising demand.
