FDA moves to expand TRT indications, shorts cover, Leerink's first take on peptides
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)
- fda.gov (16 Apr)
- FINRA via MarketBeat (17 Apr)
- Cedar Grove 13F
- Leerink (16 Apr)
A brief is a lead for our research, not a verified conclusion or advice.