By Amina Niasse
NEW YORK, Aug 12 (Reuters) - Hims & Hers Health plans to offer some legally available peptides in 2026, but investors and analysts who spoke to Reuters after the telehealth company's quarterly results this week said sales for that offering are unlikely to drive revenue growth this year.
Peptide treatments, built from short chains of amino acids, have become a healthcare rage, despite lacking FDA approval. Some of the treatments, used for everything from anti-aging to muscle recovery,
are available and some are not.
While Health Secretary Robert F. Kennedy Jr. has criticized Biden-era restrictions on some peptides, FDA staff have argued there is not sufficient evidence to support loosening the rules on compounding the treatments.
Analysts have said peptides represent a $2.2 billion to $3.3 billion market and companies marketing the treatments have said demand has increased following the April beginning of an FDA review.
CEO Andrew Dudum told investors on Monday that Hims by the end of the year will sell peptides already legal for manufacturing, including those known as NAD+, sermorelin and glutathione, used to support metabolic function, weight loss, and immune function, respectively.
Wall Street analysts and investors say that since NAD+ is already available, the offering will not have as much impact on revenue as peptides that could win FDA approval over the next year.
“There's no ‘release the floodgates’ demand like there is for other peptides that are in process of being rescheduled,” said Paul Cerro, chief investment officer at Cedar Grove Capital Management.
Morningstar analyst Keonhee Kim said because so many peptides are purchased through a grey or unauthorized market, it is difficult to assess how much Hims' plans to sell NAD+ are worth.
Hims owns one of the most popular U.S. compounding pharmacies and the company has begun stability and validation testing for BPC-157, a peptide used for tissue repair. BPC-157 is among the group of peptides undergoing FDA review for potential manufacturing by U.S. compounders.
Hims jumped to prominence thanks in part to sales of GLP-1 weight-loss drugs, and Cerro said investors should not expect peptides to grow as fast.
Kim and Raul Shah, chief investment officer at DocShah Financial, said Hims does not need to hurry to launch the peptides reviewed by the FDA before the regulator finalizes guidance.
“They already have a large number of subscribers, customer loyalty and the brand feels fairly strong," said Kim.
Dudum has said the company is awaiting "full and final rulemaking" from the FDA before selling peptides under review by the agency.
In July, an advisory panel backed allowing compounding of six peptides despite FDA staff concerns about limited evidence of safety and effectiveness. But the panel's recommendation is nonbinding. Wider access hinges on the FDA, and final rulemaking could take about a year, industry experts said.
Mark Mikhael, CEO of compounder Olympia Pharmaceuticals, said regulators could allow compounders to make certain peptides in the interim through enforcement discretion, potentially allowing Hims to launch treatments earlier than expected.
Shah said Hims has an advantage over rivals because it already owns a pharmacy capable of manufacturing peptides, having acquired a facility in 2025.
"Scaling new specialties is one of our core levers. It's something that we've done quite well over the course of the last couple of years," said Chief Financial Officer Yemi Okupe, in an interview with Reuters.
Shah expects Hims' peptide business to generate more than $1 billion in revenue over the next five to 10 years, but that revenue growth will take a while. "You have to have a long-term time horizon."
(Reporting by Amina Niasse; Editing by Pete Henderson and Aurora Ellis)
