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Hims & Hers: business model, compounded GLP-1s and regulation

How Hims & Hers makes money, what its filings say about compounded and branded GLP-1s, the FDA shortage dates, warning letters and the lawsuits on record.

Published · Updated · Rests on: FY2025 10-K, Q2 2026 10-Q and earnings release, 2 Hims press releases on Novo/Lilly, 2 FDA warning letters, 2 FDA statements, FDA GLP-1 compounding page

This is a reference article, not a price comparison. Peptilyze compares prices of research peptides; it sells nothing and gives no medical advice. Every claim is numbered and listed under Sources.

Hims & Hers Health (NYSE: HIMS) sells subscription-based telehealth care and prescription and non-prescription products online. It added GLP-1 weight-loss treatment in May 2024, first through compounded semaglutide. In 2026 the company moved its U.S. offering toward branded drugs after FDA, HHS and Novo Nordisk actions. This article uses filings, company releases and FDA documents only. The latest results release available on 2026-11-08 is the second-quarter release of 2026-08-10, because the company scheduled its third-quarter results for after the market close on 2026-11-09 [3][14].

Key points

  • By the company’s own count, Hims & Hers had about 2.9 million subscribers on 2026-06-30 and revenue of $753.2 million in the second quarter of 2026, up 38% from a year earlier [3].
  • Compounded GLP-1s were possible at scale because of FDA shortage listings. FDA declared the tirzepatide shortage resolved on 2024-12-19 (after a first decision on 2024-10-02) and the semaglutide shortage resolved on 2025-02-21 [5].
  • In March 2026 Hims said it would stop advertising compounded GLP-1s and offer them “on a limited scale”, alongside branded drugs from Novo Nordisk; in November 2026 it announced a Lilly agreement [4][13].
  • Hims lists FDA, HHS, DOJ and litigation exposure in its risk factors, and an FTC complaint was filed against it on 2026-07-29 [2].
  • Several 2025 and 2026 events could not be traced to a primary source we could open. They are flagged below.

How the business works

Hims & Hers describes a platform that connects customers to licensed providers, who can prescribe medication “when appropriate”, with prescriptions fulfilled online through licensed pharmacies. It lists sexual health, hair loss, hormone health, weight loss, dermatology and mental health among its categories [1]. The company says a majority of its customers buy through subscription plans with recurring billing [2].

The company reports a “Subscribers” metric: customers with one or more subscriptions that are billed automatically on a recurring basis [2]. Its own figures:

Period Revenue Subscribers (end of period)
Year ended 2025-12-31 $2,347.6 million (up 59% from $1,476.5 million) [1] about 2,511,000 (up 13%) [1]
Quarter ended 2026-06-30 $753.2 million (up 38%) [3] 2,891 thousand (up 19%) [3]

In the second quarter of 2026 U.S. revenue was $621.8 million (up 16%) and rest-of-world revenue was $131.4 million, helped by the June 2026 close of the Eucalyptus acquisition [2][3]. Gross margin was 64% against 76% a year earlier, and the company reported a net loss of $86.3 million against net income of $42.5 million [3]. The 10-Q attributes the cost-of-revenue increase mainly to weight-loss offerings, “some of which have higher product and packaging costs” [2]. Monthly revenue per average subscriber rose from $76 to $92, which the company ties to product mix including weight loss [2].

What Hims says about weight loss

The 10-K says Hims began providing compounded injectable semaglutide in May 2024 and acquired a licensed 503B outsourcing facility in September 2024 [1]. On 2026-03-09 it announced a “strategic shift” for the U.S.: access to a broad range of FDA-approved GLP-1 medications, with compounded semaglutide “on a limited scale” and no further advertising of compounded offerings [4]. The 10-Q says the company now uses only 503A compounding pharmacies for compounded GLP-1 products and has launched a weight-loss membership program [2].

The shift had costs. The company recorded $38.1 million of non-recurring restructuring and related charges in the six months to 2026-06-30, including $28.5 million of inventory write-downs in cost of revenue [2]. Its risk factors say customers who used compounded products may not move to branded drugs, and that branded supply and pricing sit with third parties [2].

Compounded copies of approved drugs are restricted under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. Hims states that its use of 503B facilities “was permitted based on a previous shortage” of injectable semaglutide [2]. FDA’s rules on this are covered in our explainer on compounded GLP-1 FDA rules. The dates below come from FDA’s GLP-1 compounding page, current as of 2026-04-01 [5].

Drug Shortage resolved 503A enforcement discretion 503B enforcement discretion
Tirzepatide 2024-10-02; re-evaluated and again resolved 2024-12-19 originally to 2025-02-18; FDA’s 2025-03-10 update says the period “has ended” after a court denied an injunction 2025-03-19
Semaglutide 2025-02-21 originally to 2025-04-22; a court denied an injunction on 2025-04-24 and FDA’s 2025-04-28 update says the period “has ended” 2025-05-22

FDA’s 2026-04-01 entry says semaglutide and tirzepatide are on neither the 503B bulks list nor the shortage list. It describes an “essentially a copy” test: the same active ingredient in a similar strength and the same route, unless a prescriber determines and documents a significant difference for an identified patient. FDA says it does not intend to act against compounders filling four or fewer such prescriptions a month [5]. The page does not use the word “personalized”. We found no FDA wording on it in the documents we opened.

On 2026-04-30 FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list, saying it “did not identify sufficient evidence” of clinical need. The comment period was first set to close on 2026-06-29 [9] and was later extended to 2026-07-30 [15]; we did not find a final decision.

What FDA has said and sent

  • Warning letters, 2025-09-09. FDA’s drug center sent separate letters to Hims & Hers (hims.com) and Hers (forhers.com) after reviewing the websites in August 2025. They cite claims such as “Same active ingredient as Ozempic and Wegovy” and “Clinically proven ingredients”, and call the compounded semaglutide misbranded under section 502(a) and 502(bb) [7][8]. Hims’s filings confirm it received warning letters in September 2025 about website statements on compounded semaglutide [1][2].
  • Warning letter, December 2025. According to Hims, its own outsourcing facility received a warning letter for failing to submit an adverse event report and for deficient reporting procedures. The letter itself was not opened; this is the company’s description [1][2].
  • FDA statement, 2026-02-06. FDA said it intends to “restrict GLP-1 active pharmaceutical ingredients” for non-approved compounded drugs. It named “Hims & Hers and other compounding pharmacies” as mass-marketing them as alternatives to approved drugs, and said firms cannot call compounded drugs generic, the same as approved drugs or clinically proven [6].
  • HHS referral, February 2026. Hims reports that HHS’s general counsel said on X that it had referred the company to the Department of Justice. We did not open that post. As of the 10-Q, Hims says it is “unclear” what FDA, HHS or DOJ may do [1][2].

Relationship with Novo Nordisk and Eli Lilly

Novo Nordisk. On 2025-04-29 Hims announced an extended partnership under which Wegovy was offered with a membership through NovoCare Pharmacy [10]. Press reports say Novo ended the collaboration on 2025-06-23. We could not open a primary statement from Novo or Hims on that, so the end date and Novo’s stated reasons are unverified here. Hims’s filings say the securities suit concerns “the business relationship” with Novo for 2025-04-29 to 2025-06-22 [2]. On 2026-02-09 Novo sued Hims for patent infringement over compounded semaglutide. Novo dismissed it without prejudice on 2026-03-09 and reserved the right to refile [2]. The same day Hims announced a new agreement bringing Ozempic and Wegovy to the platform [4]; Wegovy pills and pens launched on 2026-03-26 [11].

Eli Lilly. Neither the 10-K nor the Q2 10-Q names Lilly. On 2026-04-23 Hims said providers could send Zepbound and Foundayo prescriptions to the LillyDirect pharmacy, adding that this “does not imply a partnership or affiliation” with Lilly [12]. On 2026-11-06 Lilly and Hims announced an agreement, with a statement that Hims “has never offered access to compounded copies of Lilly’s GLP-1s” and will not [13]. For Lilly’s side, see our Eli Lilly business overview.

Lawsuits and regulatory actions on record

As of the Q2 2026 10-Q [2]:

  • FTC. Filed 2026-07-29 in the Northern District of California with Utah and Los Angeles County; alleges violations of the FTC Act and ROSCA over practices including subscription and cancellation. It seeks an injunction and monetary relief. A related privacy class action (Doe v. Hims & Hers) followed.
  • Securities class action. In re Hims & Hers Health, Inc. Securities Litigation covers 2025-04-29 to 2025-06-22 and alleges misstatements about the Novo relationship. Hims does not consider a loss probable. Derivative suits are stayed.
  • Australia. The TGA issued compulsory notices to Eucalyptus subsidiaries, before the acquisition, over prescription-medicine advertising.

Risk factors Hims lists

The filings list: the evolving rules on compounded GLP-1s and possible penalties; FDA’s possible “Demonstrable Difficulties for Compounding” list, which manufacturers asked to include semaglutide and tirzepatide [1]; the FDA and HHS statements and DOJ referral; false-or-misleading-promotion enforcement; negative public perception of compounded drugs; branded-supply constraints and reliance on one supplier for some weight-loss offerings; customer loss in the move to branded drugs; margin pressure; and litigation [1][2].

Frequently asked questions

Did FDA ban compounded semaglutide and tirzepatide? FDA ended the shortages and the related enforcement discretion for both drugs. Compounding is still allowed under the 503A and 503B conditions, including the “essentially a copy” test [5]. FDA’s 2026 statements describe intended restrictions, and its 503B proposal was still open for comment in our sources [6][9].

Does Hims & Hers still offer compounded GLP-1s? The 10-Q says it offers them “on a limited scale” through 503A pharmacies [2]. The March 2026 release said this is for customers whose provider finds a compounded product clinically necessary [4].

Is Hims & Hers partnered with Novo Nordisk and Lilly? It has a March 2026 agreement with Novo and a November 2026 agreement with Lilly, per its releases [4][13]. Its April 2026 release said Zepbound access implied no partnership [12].

What is the latest financial data? The Q2 2026 release dated 2026-08-10 [3]. Third-quarter results were due on 2026-11-09 [14].

Sources

  1. Hims & Hers Health, Inc., Form 10-K for fiscal year 2025 (filed 2026-02-23). https://www.sec.gov/Archives/edgar/data/1773751/000177375126000022/hims-20251231.htm
  2. Hims & Hers Health, Inc., Form 10-Q for the quarter ended 2026-06-30 (filed 2026-08-10). https://www.sec.gov/Archives/edgar/data/0001773751/000177375126000163/hims-20260630.htm
  3. Hims & Hers Health, Inc., “Reports Second Quarter 2026 Financial Results” (8-K Exhibit 99.1, 2026-08-10). https://www.sec.gov/Archives/edgar/data/0001773751/000177375126000161/hims-20260630x8xkearningsr.htm
  4. Hims & Hers Health, Inc., “Hims & Hers announces strategic shift for US weight loss business” (8-K Exhibit 99.1, 2026-03-09). https://www.sec.gov/Archives/edgar/data/1773751/000177375126000033/ex991pressrelease.htm
  5. FDA, “FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize” (content current 2026-04-01). https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize
  6. FDA, “FDA intends to take action against non-FDA-approved GLP-1 drugs” (2026-02-06). https://www.fda.gov/news-events/press-announcements/fda-intends-take-action-against-non-fda-approved-glp-1-drugs
  7. FDA, Warning Letter to Hims & Hers Health, Inc. dba Hims, MARCS-CMS 716567 (2025-09-09). https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hims-hers-health-inc-dba-hims-716567-09092025
  8. FDA, Warning Letter to Hims & Hers Health, Inc. dba Hers, MARCS-CMS 716825 (2025-09-09). https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hims-hers-health-inc-dba-hers-716825-09092025
  9. FDA, “FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List” (2026-04-30). https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list
  10. Hims & Hers, “Hims & Hers and Novo Nordisk Team Up to Expand Affordable Access to Care” (2025-04-29). https://news.hims.com/newsroom/hims-hers-and-novo-nordisk-team-up-to-expand-affordable-access-to-care
  11. Hims & Hers, “Wegovy Pill and Wegovy Pen Now Available with Hims & Hers” (2026-03-26). https://news.hims.com/newsroom/wegovy-r-pill-and-wegovy-r-pen-now-available-with-hims-hers
  12. Hims & Hers, “Full Range of FDA-Approved GLP-1s Available on Hims & Hers” (2026-04-23). https://news.hims.com/newsroom/full-range-of-fda-approved-glp-1s-available-on-hims-hers
  13. Eli Lilly and Company and Hims & Hers, “Lilly and Hims & Hers Expand Access to FDA-Approved Lilly Medicines” (2026-11-06). https://news.hims.com/newsroom/lilly-and-hims-hers-expand-access-to-fda-approved-lilly-medicines
  14. Hims & Hers Health, Inc., “Hims & Hers to Announce Third Quarter 2026 Financial Results on November 9, 2026” (2026-10-12). https://investors.hims.com/news/news-details/2026/Hims--Hers-to-Announce-Third-Quarter-2026-Financial-Results-on-November-9-2026/default.aspx
  15. FDA, “List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period,” Docket FDA-2018-N-3240, Federal Register public inspection copy, scheduled for publication 2026-06-26. https://public-inspection.federalregister.gov/2026-12937.pdf

This article is information, not medical advice.

This is not investment advice.

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