The telehealth company said its initial offering would include NAD+, sermorelin and glutathione, with plans to expand into compounded versions of BPC-157 and TB-500, substances that have attracted interest in the wellness and fitness markets but have not received approval from the US Food and Drug Administration (FDA).
Hims & Hers shares declined more than 3% in volatile after-hours trading following Monday’s announcements.
Expands into Peptide-Based Treatments
Chief Executive Officer Andrew Dudum said the company intends to manufacture BPC-157 and TB-500 in the United States as part of its expansion into peptide-based products.
The two substances are frequently used together by consumers seeking fitness and recovery benefits, in a combination commonly referred to as the “Wolverine stack.”
Peptides are short chains of amino acids that have attracted increased consumer attention, particularly through social media discussions about potential applications involving ageing, physical recovery and sexual health.
However, the treatments covered by the company’s expansion plans have not received FDA approval for the proposed uses.
Recent changes in US regulatory policy have relaxed certain restrictions on compounding unapproved peptides. The changes involve regulatory enforcement discretion and do not constitute FDA approval or establish the safety and effectiveness of the substances.
Reg Changes Raise Questions About Product Safety
US Health Secretary Robert F. Kennedy Jr. has supported broader access to peptide treatments, describing himself as a “big fan” of the products.
Kennedy has argued that restrictions on domestic access could encourage consumers to purchase potentially unsafe products from overseas suppliers.
Critics of the revised regulatory approach have raised concerns about contamination, impurities and side effects that may not be fully understood.
They have also argued that peptide products should undergo the FDA’s established drug approval process before being manufactured and prescribed.
The distinction between regulatory enforcement discretion and formal drug approval remains relevant to the company’s plans, particularly as it prepares to introduce products that lack FDA authorisation.
Chief Financial Officer Yemi Okupe said revenue generated by the peptide treatments was expected to be immaterial for the remainder of the year.
Branded Weight-Loss Meds Affect Profit Margins
Alongside the peptide announcement, Hims & Hers lowered its full-year core profit forecast, citing higher expenses associated with its transition towards branded weight-loss medications and international expansion.
The company has recently entered into an agreement to offer obesity treatments developed by Eli Lilly, adding to an existing partnership with Novo Nordisk.
The shift towards branded pharmaceutical products has increased the cost of revenue compared with the company’s previous product mix.
Gross margin declined to 57% in the third quarter from 74% in the corresponding period a year earlier.
Paul Cerro, chief investment officer at Cedar Grove Capital Management, which holds shares in Hims & Hers, said the margin decline was consistent with the company’s expansion strategy.
“Margin compression was to be expected,” Cerro said.
“This is all part of growing their condition categories and attracting more subscribers.”
Morningstar analyst Keonhee Kim similarly indicated that a greater proportion of branded weight-loss products was contributing to higher revenue per subscriber while placing pressure on gross margins in the near term.
Subscriber Base Reaches Nearly 2.8 Million
Hims & Hers reported a 13% year-on-year increase in subscribers, bringing its customer base to nearly 2.8 million.
Monthly revenue per average subscriber rose 30% to $105.
In an interview with Reuters, CFO Okupe said menopause therapies and testosterone testing contributed to the increase in revenue generated per subscriber.
The company’s expansion into additional treatment categories has supported higher customer spending, although changes in the product mix have also affected profitability.
Okupe said the agreement with Eli Lilly was expected to support customer retention.
International Revenue More Than Quadruples
Revenue from markets outside the United States increased more than fourfold to $233.3 million, reflecting the contribution from the company’s international expansion.
US revenue rose 21% to $657.1 million.
Despite the increase in both domestic and international revenue, Hims & Hers narrowed its full-year revenue guidance to between $3.13 billion and $3.15 billion, compared with its previous forecast of $3.1 billion to $3.3 billion.
Morningstar’s Kim attributed the revenue shortfall primarily to slower growth in the company’s US operations, which offset the contribution from international markets.
The revised guidance reflects a narrower range of expected annual revenue as the company continues to expand its treatment offerings and geographic operations.
Q3 Revenue Rises 49% as Company Reports Net Loss
Hims & Hers reported third-quarter revenue of $890.4 million, representing a 49% increase from the corresponding period a year earlier.
The result was slightly below the average analyst estimate of $892.9 million, according to data compiled by LSEG.
The company recorded a quarterly net loss of $33 million, compared with net income of $15.8 million in the same period of the previous year.
The change in profitability coincided with increased operating costs, international expansion and a greater proportion of branded medications in the company’s revenue mix.
Outlook
Hims & Hers continues to expand its healthcare offerings through new treatment categories, branded pharmaceutical partnerships and international operations.
The planned introduction of peptide-based treatments represents an additional product initiative, although management expects the contribution to revenue during the remainder of the year to be immaterial.
The company’s near-term financial performance will depend on subscriber growth, revenue per customer, the cost of branded medications and expenses associated with geographic expansion.
Investors will also be monitoring developments in the regulatory treatment of compounded peptides and the company’s ability to manage profitability as its product portfolio changes.
https://finviz.com/news/419781/hims-hers-plans-november-launch-of-peptide-treatments-as-higher-costs-weigh-on-profit-outlook