What will Hims say during their next earnings call?

FDA aggressively targeted compounded GLP-1s, directly impacting Hims. On February 6, 2026, FDA Commissioner Martin Makary stated the agency's intent to take "decisive steps" to restrict the use of GLP-1 active pharmaceutical ingredients (APIs) in non–FDA-approved compounded drugs being mass-marketed. The FDA stated it cannot verify the quality, safety, or efficacy of these products and cautioned against claims that they are generic versions, "the same as" FDA-approved drugs, or clinically proven ^[1]. Notably, the FDA explicitly named "Hims & Hers" due to compliance issues with a Hims-owned compounder. A STAT report detailed that MedisourceRx, a compounder associated with Hims, received an FDA warning letter for failing to report a serious adverse event, specifically a patient hospitalization involving a compounded semaglutide product, within the required 15 days. This incident highlights the FDA's readiness to address compliance within Hims' supply chain ^[4].

Additional regulatory actions targeted telehealth companies and clarified compounding policies. On March 3, 2026, the FDA issued 30 warning letters to various telehealth companies for making false or misleading claims about compounded GLP-1 products ^[2][3]. These violations included implying compounded products were identical to FDA-approved drugs and obscuring product sourcing by branding them under the telehealth firm's name without proper qualification ^[2][3]. An April 1, 2026, policy clarification further reminded compounders that their products must meet specific statutory conditions for 503A/503B exemptions and reinforced restrictions on compounding drugs that are "essentially a copy" of FDA-approved alternatives ^[5].

Peptide-based weight loss emerges as Hims' primary growth driver in 2026. Industry reports indicate that this area is perceived as a "strategic pivot" and a potential "new primary growth narrative" by market observers ^[1][2]. Anticipated FDA regulatory developments concerning peptides are seen as a key catalyst for the company's future growth ^[3]. For instance, a TIKR report mentioned an April 16 FDA expert panel on 12 peptides, with Leerink suggesting this could enable Hims to utilize its existing peptide facility as demand for compounded weight-loss treatments evolves ^[3]. World Today News further noted that Q1 2026 call data indicated that peptide-related regulatory changes could open a multi-billion-dollar addressable market by 2028 ^[1].

Hims management prioritizes peptide durability and new weight-loss strategies. The company is strategically positioning its weight-loss business to maintain durability, even if GLP-1 compounding faces restrictions ^[4]. According to STAT's February 2026 earnings-call coverage, CEO Andrew Dudum emphasized a "really durable weight business," signaling a potential future focus on other weight-loss-peptide initiatives ^[4]. A March 2026 investor update by Hims detailed a shift in its U.S. weight-loss strategy with Novo Nordisk, leading analysts to anticipate future growth from an approved GLP-1 mix along with new treatment options, potentially including peptide-based offerings ^[5]. Market expectations for the May 11, 2026 call frame it as a crucial "first real test" of the recent Hims rally, scrutinizing management's narrative around the Novo Nordisk partnership and the peptide pipeline ^[2][6][7].

Hims dramatically shifted its GLP-1 strategy toward FDA-approved medications in Q1 2026, aligning with competitors like Amazon Pharmacy and Ro. This pivot was underscored by a March 2026 collaboration with Novo Nordisk, enabling Hims to offer brand-name Ozempic and Wegovy, available in both injectable and oral forms, through its platform ^[1][2][3][4]. As part of this change, Hims announced it would cease advertising compounded GLP-1 offerings and support existing patients in transitioning to FDA-approved medicines when clinically appropriate. While primarily focusing on FDA-approved options, compounded GLP-1s will remain available on a limited basis for patients with specific clinical needs and medical approval from a provider ^[1][2][3]. This strategic move is timely given the FDA's proposed restrictions on compounded GLP-1 drugs, and Hims is also expanding its services into other health areas such as hormone therapy and diagnostics ^{[9][10][5][11][4]}.

Competitors like Amazon Pharmacy and Ro primarily offer FDA-approved GLP-1 medications, each with distinct program features. Amazon Pharmacy consistently focuses on FDA-approved weight management solutions, providing both oral options like Wegovy and Foundayo, alongside injectables such as Wegovy, Zepbound, and KwikPen ^[6][7][8]. Their program adopts a holistic approach, integrating primary care, Amazon Pharmacy services, and virtual care to manage obesity as a chronic condition, emphasizing convenience with nationwide and same-day delivery options in many cities, as well as transparent pricing that automatically applies manufacturer coupons ^[6][7][8]. Similarly, Ro's "Ro Body Program" offers telehealth services with access to prescription FDA-approved GLP-1 medications, including Wegovy, Ozempic, Zepbound, and Saxenda ^[12][13][14]. Ro specifically ceased selling compounded GLP-1s in early 2026, now exclusively providing FDA-approved options and matching manufacturer pricing for cash-paying customers ^[5]. A notable aspect of Ro's program is its "insurance concierge" service, designed to help patients navigate insurance coverage, prior authorizations, and appeals for GLP-1 medications. The program also includes a membership fee, one-on-one personal coaching, and educational resources ^[15][16][5].

Publicly available data explicitly detailing prescription volumes for Hims' key telehealth categories, such as peptides and lab testing, for the first quarter of 2026 is not currently accessible. Hims & Hers Health, Inc. plans to release its first-quarter 2026 financial results after the market closes on Monday, May 11, 2026. This announcement will serve as the primary source for detailed company-specific information, and the company will also host a live conference call to discuss these results ^[1][2][3][4].

Broader telehealth reports and regulatory changes impact the market landscape. A "2026 State of Peptides and GLP-1 Regulation report" was released in April 2026 by FormBlends, a telehealth platform specializing in GLP-1 therapy and peptide research, though the report does not specify if it tracks Q1 2026 prescription volumes ^[5]. Further, the FDA is expected to review certain peptides for potential compounding access in July 2026 ^[8][9]. Telemedicine flexibilities for prescribing controlled medications have also been extended by the HHS and DEA through December 31, 2026 ^[6][7].

Hims anticipates a significant Canadian weight loss market entry in 2026. This expansion is closely tied to the generic semaglutide patent expiry in January 2026, a crucial factor for its planned weight loss launch. While the patent expires early in the year, the availability of generic semaglutide is projected for mid-2026 ^[1][2][3]. Hims' entry into the Canadian market was made possible by the Livewell acquisition, finalized in December 2025 ^[7].

No specific European Q1 2026 milestones are highlighted by research. The company's European operations, which cover the UK, Germany, France, and Ireland, were established through the ZAVA acquisition in the second half of 2025 ^[8][9][10]. International operations are identified as a growth driver, contributing to the 2025 Rest of World revenue of $134 million, reflecting a substantial 399% year-over-year increase ^[4][5][6]. The upcoming Q1 2026 report will mark the first time a comprehensive US versus Rest of World revenue split is included ^[5][11].

Hims & Hers will host its First Quarter 2026 earnings call on May 11, 2026, at 5:00 p.m. ET, following the release of Q1 results after the market closes the same day ^[1][2]. Management previously guided for an approximately $65 million first-quarter revenue headwind, attributable to a shift in weight-loss shipping cadences to 503A fulfillment ^[3]. Additionally, the company expects further EBITDA pressure related to its planned 60-second Super Bowl commercial investment ^[3].

Street expectations for the May 11, 2026 Q1 2026 release include a consensus EPS of $0.03 and revenue of $616.9M ^[4]. This outlook comes with a wide EPS range (loss of $0.04 to $0.15) and has seen downward revisions over the prior three months ^[4]. Polymarket’s "Will Hims & Hers Health (HIMS) beat quarterly earnings?" market, set to resolve on or around May 11, 2026, showed a crowd-sourced probability of 49% for "Yes" at the time captured by the source ^[5]. A separate prediction-market article claims a market probability of 85.5% for a beat for the May 11, 2026 resolution, though this appears as secondary commentary ^[6].