FDA update could extend Hims & Hers’ compounding timeline, says BofA

BofA analyst Allen Lutz notes that the Food and Drug Administration yesterday provided updated enforcement timelines for semaglutide and tirzepatide compounding. The court’s decision on tirzepatide took about six months from the initial date of the Outsourcing Facilities Association complaint and could be a precedent on timing for semaglutide, adds the analyst. Based on the tirzepatide timeline, the news suggests that the commercial 503B semaglutide compounding opportunity for Hims & Hers could extend beyond May and the firm notes that “the lion’s share” of $725M in weight loss revenue guidance for 2025 likely reflects semaglutide contributions, so yesterday’s decisions “partly de-risks this component of the guide.” BofA maintains an Underperform rating and $21 price target on Hims shares.