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HIMS

FDA moves to expand TRT indications, shorts cover, Leerink's first take on peptides

Sources (4)

Leerink

Michael Cherny

Current price

$26.99

PT

$25

Rating

Hold

Significance

The sell-side is starting to move peptides from 'optional' to 'must-have growth engine', though valuations are following cautiously

Source

Leerink research note, 16 Apr

View

HIMS will push hard on peptides as a growth path, but they will not turn into revenue straight away

Short interest

Cedar Grove

Cedar Grove Capital 13F: it shorted on results day, covered at a profit the next day and has held no short position since. More evidence that deep shorts are heading for the exit together.

Change

Down 11.93 million shares (-14.3%), a steep fall in a single month

15 Mar

83.29 million shares

31 Mar

71.36 million shares (36.3% of float)

Peak

About 85 million shares on 28 Feb (46.09%)

Source

FINRA (compiled by MarketBeat, 17 Apr); Cedar Grove 13F

Trend

Falling steadily for 2.5 months

TRT catalyst

FDA action

FDA press release, 16 Apr: holders of approved TRT applications are encouraged to contact the FDA by 30 Apr to file a supplemental NDA for idiopathic hypogonadism with low libido

HIMS positioning

HIMS announced last year that it plans to be the exclusive channel for an oral testosterone product

Makary quote

Commissioner Makary weighed in personally: emerging data support the view that TRT may be effective for low libido

Significance

A second, independent path to deregulation beyond peptides, directly enlarging HIMS's hormonal health TAM

Source

fda.gov press release (16 Apr)

Risk flag

Concern

It is banned by WADA and the scientific evidence is thin, so it could be dropped when the FDA advisory committee meets on 23-24 Jul

Implication

The final approved list may be shorter than expected

Issue

RFK's list of candidate peptides includes MK-677 (a growth hormone secretagogue)

Sources 4

  1. fda.gov (16 Apr)
  2. FINRA via MarketBeat (17 Apr)
  3. Cedar Grove 13F
  4. Leerink (16 Apr)

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