Hims & Hers Health announced plans to introduce additional peptide-based treatments in November following changes to US regulatory restrictions, while cutting its full-year core profit forecast as costs rose.

The initial offering will include NAD+, sermorelin and glutathione, with plans to expand into compounded versions of BPC-157 and TB-500. Peptides are short chains of amino acids, and these two in particular have built a following in fitness circles, where the pairing is known as the "Wolverine stack."

Enforcement discretion is not approval

This is the sentence the story turns on. Recent US policy changes have relaxed certain restrictions on compounding unapproved peptides, but the company's own framing is clear that this involves regulatory enforcement discretion and does not constitute FDA approval or establish safety and effectiveness. None of the treatments covered by the expansion have FDA approval for the proposed uses.

Health Secretary Robert F. Kennedy Jr. has supported broader access, describing himself as a "big fan" of peptide products and arguing that domestic restrictions push consumers toward potentially unsafe overseas suppliers. Critics have raised concerns about contamination, impurities and side effects that may not be fully understood, and argue these products should go through the established drug approval process first.

What the numbers actually say

The peptide line is not why the stock moved. Gross margin fell to 57% in the third quarter from 74% a year earlier, driven by the shift toward branded weight-loss medications through partnerships with Eli Lilly and Novo Nordisk. Shares declined more than 3% in volatile after-hours trading.

Third-quarter revenue reached $890.4 million, up 49% year over year but slightly below the average analyst estimate of $892.9 million, according to LSEG data. The company posted a quarterly net loss of $33 million against net income of $15.8 million a year earlier, and narrowed full-year revenue guidance to $3.13 billion to $3.15 billion from $3.1 billion to $3.3 billion.

A product line nobody expects to earn yet

CFO Yemi Okupe said peptide revenue is expected to be immaterial for the remainder of the year. That is worth holding onto: a telehealth company with nearly 2.8 million subscribers, up 13%, is building a compounded peptide category it does not expect to monetize this quarter.

Bottom line

CEO Andrew Dudum says BPC-157 and TB-500 would be manufactured in the United States. What remains unsettled is how long enforcement discretion lasts, and whether the regulatory posture that made this launch possible holds.