Digital health and wellness company Hims & Hers is ready to tap into a multi-billion dollar peptide market if U.S. regulators loosen restrictions on manufacturing.
The company plans to offer already-permitted peptides, such as sermorelin, glutathione and NAD+, which are popular wellness and anti-aging compounds, by the end of the year, Andrew Dudum, co-founder, chairman and CEO of Hims & Hers, told investors on Monday during the company's second-quarter earnings call.
"Moments like this, where a category is surging in popularity while the market is struggling to find a safe, sustainable way to support it is where our scale, infrastructure and ecosystem thrive. We are currently developing a best-in-class peptides experience, including U.S.-manufactured products, clinically led guidance and ongoing blood testing," Dudum told analysts and investors on the call.
Peptides are in the spotlight due to the massive success of Food and Drug Administration-approved GLP-1 weight loss medications like Ozempic and Wegovy, which are peptide drugs. Wellness influencers and biohackers on social media are promoting other lab-made peptides for fast-tracked healing, anti-aging and muscle growth.
Health and Human Services Secretary Robert F. Kennedy Jr. has championed looser federal rules on trendy, unapproved peptide injections. In July, an FDA advisory committee recommended broader access to six unapproved peptides. The panel recommended adding these six substances to the Section 503A Bulks List, which would remove the restrictions on how they are produced by compounders, Fierce Pharma reported.
Research firm Needham & Co. estimates the peptide market could be as large as $3.3 billion, while Leerink analyst Michael Cherny estimates the market at $2.2 billion, Reuters reported.
Hims & Hers is keeping a close eye on the regulatory landscape.
"I'm extremely excited about this category, holistically, the peptide and wellness category, and was very excited to see six of the seven go through successfully with the PCAC (Pharmacy Compounding Advisory Committee) meeting at the FDA a couple of weeks back," Dudm told investors on Monday. "We've made incredible progress in the last couple of quarters on the clinical guidelines as well as the supply chain that gives me confidence that if and when the FDA does decide to move these peptides to the Category 1 list, we'll be able to move extremely quickly."
The company acquired a California-based peptide manufacturing facility in February 2025, which gives it a fully verticalized U.S. supply chain, executives said.
Hims & Hers has built a fast-growing business by offering consumers personalized compounded formulations to address conditions such as hair loss, dermatology and sexual health. Earlier this year, the company shifted its weight loss strategy from mass-marketed compounded GLP-1 drugs to FDA-approved brand-name options. Peptides represent a big market opportunity for Hims & Hers as it also expands its business in international markets.
"While we wait to hear the FDA's decision on the six peptides recommended at the last month's PCAC (Pharmacy Compounding Advisory Committee) hearing, we've started validation and stability testing on APIs (active pharmaceutical ingredients) for those peptides developed in our Menlo Park facility," Dudum said. "This will ensure we can bring them to the market with a safe, verified supply chain if the FDA decides to allow them for compounding."
In June, the company brought on Anant Vinjamoori, M.D., as its chief medical officer for the Hims business to shape the next phase of the brand across sexual health, hormone health, dermatology, weight loss and mental health, as well as emerging categories like longevity medicine and peptide therapy.
"He's been building out the clinical protocols, the guardrails, the dosing regimens and the provider training," Dudum said.
The company reported strong revenue growth in the second quarter, bringing in $753 million, up 38% compared to revenue of $545 million a year ago. Domestic revenue growth accelerated 16% year-over-year to reach $622 million. "The pivot we made in March to expand the assortment of branded weight loss products on our platform was a key driver of the reaccelerating growth in the second quarter as more subscriber additions offset revenue recognition headwinds from the shift to a monthly cadence in branded weight loss offerings," Chief Financial Officer Yemi Okupe said during the call.
The company's international business grew more than 17-fold, strengthened by the close of Hims & Hers' Eucalyptus acquisition in June, executives said. That acquisition deepened the company's presence in Europe and extended its reach to Australian and Japanese consumers. International revenue grew from $7.5 million to $131 million.
But the company's growth came at a cost, with weaker profitability during the quarter. Faced with higher expenses, Hims & Hers swung to an $86 million loss in Q2 compared to $43 million in profit the same quarter a year ago.
The company reported $81 million of nonrecurring costs during Q2 consisting of acquisition and transaction costs tied to the closing of its Eucalyptus acquisition and restructuring costs tied to the company's exit from compounded GLP-1 weight-loss drugs, Okupe said.
The company is also facing a lawsuit filed by the Federal Trade Commission, along with Utah and California authorities, alleging it misled consumers about privacy, billing and subscription practices. That litigation also drove up $47.5 million in legal charges during the quarter.
"Following nearly three years of cooperation throughout the FTC's investigation and several months of good faith settlement negotiations, the FTC filed a complaint on July 29. Ultimately, we were not prepared to accept the terms we do not believe reflect the facts or the law. We are confident in our position and intend to defend it vigorously," Okupe said.
These costs are squeezing the company's margins, as Hims & Hers' gross margin in Q2 was 64% compared to 76% for the second quarter of 2025.
"This compression reflects deliberate strategic action to scale the specialties and markets that we believe will drive the long-term value of our platform. We do not believe anyone else in consumer health has the scale, infrastructure and balance sheet to invest in this way. As branded weight loss products and international revenue become a larger portion of the business, we expect gross margins will remain below the levels we have historically achieved," Okupe said.
Adjusted EBITDA in the quarter was $60.3 million compared to $82.2 million for the second quarter of 2025.
The company reported a loss per share of 37 cents, compared with Wall Street analysts' expectations for a loss of about five cents per share.
During the quarter, operating cash flow was negative $36 million and free cash flow was negative $68 million, reflecting the increased working capital demands associated with the company's rapidly expanding branded weight loss offering.
But Hims & Hers' executives were upbeat about the company's performance so far in 2026, touting the company's strong subscriber growth, continued expansion into international markets and heavy investment in AI and technology.
The company's subscribers grew to nearly 2.9 million, up 19% year-over-year in Q2 2026.
On the tech front, the company is "weaving AI into the entire platform," Dudum said, to deliver an AI-native health experience that "no other peer or LLM can match," he noted. "We support customers through their entire health journey from their very first question to their clinical treatment and continued follow-up care. That end-to-end closed-loop relationship, combined with our scale, is incredibly powerful," he said.
"Other health companies major in the minor. They tack on minor improvements to the existing system while we're making our platform completely AI-native, so that our platform can provide an integrated experience that is alive and personal, one where AI coaches and support agents, a care team, a clinician and a pharmacy are one unified system with a single goal: keeping people well," Dudum said.
The company recently launched an AI-powered care experience for Hers' patients that integrates personalized support, provider oversight and real-time progress tracking into a single platform.
Mohamed Elshenawy, Hims & Hers' chief technology officer, said the AI-native experience just launched for Hers' weight loss customers is driving "meaningful change" for customers.
"Our AI-centric technical strategy is the difference between adding a feature and reimagining the entire customer experience. We are making AI load-bearing, not decorative. We are replacing the traditional telehealth model with something entirely new for our industry, a unified care experience where customers' care team lives in a single platform that already knows them," he said.
Okupe said the company's expectation is that AI investments will pay back within 12 to 18 months. "More importantly, we believe these capabilities, combined with our scale, provide structural advantages to invest in ways that others cannot across key growth areas like weight loss and international markets," he said.
Based on a phased rollout in early July, the new app has driven increased engagement. Hers customers using the new care experience are sending 3x as many messages on the platform, with AI answering 80% of their questions to support their treatment journey, while also demonstrating AI has the capacity to drive a 50% reduction in nonclinical tasks handled by support teams, executives noted.
Okupe also noted that collaborations with pharmaceutical firms like Novo Nordisk are resulting in "real marketing tailwinds." "We've seen groundbreaking treatments draw enormous consumer attention to categories like weight loss," he said.
The company also plans to continue investing in the operational capabilities and clinical oversight required to bring new offerings to the platform, including higher-complexity offerings like injectable testosterone in the near term and peptide therapies if the regulatory landscape allows, Okupe said.
Hims & Hers raised full-year 2026 revenue guidance to a range of $3.1 billion to $3.3 billion and updated adjusted EBITDA guidance to a range of $275 million to $325 million.
The company touted its 2030 ambitions to hit at least $6.5 billion in revenue and $1.3 billion in adjusted EBITDA.