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HIMS

Daily: peptide launch timetable, Q3 guidance and a split sell side

Sources (7)

The Q2 call set out the timing for peptides. Before year end HIMS will launch wellness peptides that need no approval (sermorelin, glutathione, NAD+) to build volume and stake out the space.

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The 6 major 503A peptides recommended by the advisory committee on 23-24 Jul (including BPC-157) will go on sale only once FDA rulemaking is finalised, which could take months to years and is not guaranteed to pass. That pushes back the timing of Lupton's $10 billion to $19 billion TAM. The counter-evidence: a wellness peptide that can legally be compounded is not a peptide with proven efficacy, and with the 29 Jul FTC privacy lawsuit unresolved, that adds up to a tail risk. Q3 revenue guidance came for the first time at $880 million to $900 million (full year raised to $3.1 billion to $3.3 billion), and profits are still back-loaded into Q4. The sell side is split: Needham raised its price target to $42 (the Street high), while Citi, at Neutral, cut from $35 to $33 and warned that the Q4 profit jump is an execution risk. The core tension is still subscriber growth against a 64% gross margin (down 12 percentage points year on year). At about 60x forward P/E and more than 50% below the year's high of $70.43, risk/reward leans cautious.

Key evidence

  • On the Q2 call Dudum said HIMS will launch sermorelin (a growth hormone-releasing hormone fragment), glutathione and NAD+ before year end. All three can legally be compounded now and will be positioned for wellness and anti-ageing, with no need to wait for new FDA rules
  • Waiting for the FDA's final rule: the 6 peptides recommended by the advisory committee on 23-24 Jul (including BPC-157). The Menlo Park plant is already running stability and validation tests on the active ingredients, and Dudum was explicit that they will not be sold until formal FDA rulemaking is in place
  • FDA rulemaking timeline: Dudum was explicit that it will take months to years and approval is not guaranteed
  • The $10 billion to $19 billion peptide TAM estimated by Lupton on the buy side assumes the major 503A peptides are cleared, so its timing has been pushed back
  • Counter-evidence (Medical Daily, 12 Aug, following the 12 Jun Nature thread): sermorelin only has evidence for diagnosing growth hormone deficiency in children, while glutathione and NAD+ rest on mechanistic reasoning and animal studies, with no human trials of anti-ageing outcomes
  • HIMS's patch is to add blood tests and clinical guidance, which does not fill the efficacy gap
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  • The 29 Jul FTC privacy lawsuit is still unresolved, and selling products of unproven efficacy during a sensitive compliance period is a tail risk
  • First Q3 revenue guidance: $880 million to $900 million (Seeking Alpha, citing the call)
  • Full-year guidance raised to $3.1 billion to $3.3 billion; profits are still back-loaded into Q4
  • Needham kept Buy and raised its price target to $42 (positive on revenue and the peptide TAM; at the top of the Street range)
  • Citi cut its target from $35 to $33 and kept Neutral, warning that the sharp Q4 profit jump implied by full-year guidance carries high execution risk
  • Analysts conclude that record subscriber growth is not enough to offset the fall in gross margin. The core tension is still subscriber growth against a 64% gross margin (down 12pp year on year)
  • The shares trade at about 60x forward P/E, more than 50% below the year's high of $70.43

Catalysts to watch

  • Launch of wellness peptides (sermorelin, glutathione, NAD+) before year end: the first window for measurable peptide revenue
  • FDA rulemaking on the major 503A peptides, which decides whether BPC-157 and the others can deliver Lupton's $10 billion to $19 billion TAM
  • Q4 profit delivery: the execution risk Citi flagged, and the key test of whether full-year guidance is credible

Risks

  • Efficacy gap: a legal wellness peptide is not a proven one, and there are no human trials of anti-ageing outcomes
  • Regulatory tail: the 29 Jul FTC privacy lawsuit is unresolved, and HIMS is selling products of unproven efficacy during a sensitive compliance period
  • TAM timing slips: rulemaking on the major 503A peptides could take months to years with no guarantee of approval, which pushes back the timing of buy-side TAM assumptions
  • Profit execution: the sharp Q4 profit jump implied by full-year guidance is an execution risk (Citi)
  • Structural tension: record subscriber growth against a 64% gross margin, down 12pp year on year. Growth cannot offset the margin decline
  • Valuation: 60x forward P/E and more than 50% below the year's high; risk/reward leans cautious

Sources 7

  1. HIMS Q2 earnings call (Dudum on the peptide launch timetable)
  2. Seeking Alpha (Q3 revenue guidance of $880 million to $900 million)
  3. Medical Daily, 12 Aug (counter-evidence following the 12 Jun Nature thread)
  4. Needham post-results note ($42 price target)
  5. Citi post-results note ($35 to $33)
  6. FDA advisory committee recommendation of 6 peptides, 23-24 Jul (including BPC-157)
  7. Public filings in the 29 Jul FTC privacy lawsuit

A brief is a lead for our research, not a verified conclusion or advice.