Rhythm Pharmaceuticals, Inc.

What they do

Rhythm develops and commercializes MC4R agonists, led by IMCIVREE (setmelanotide), as precision medicines for hyperphagia and severe obesity caused by rare MC4R pathway diseases including acquired or congenital hypothalamic obesity, Bardet-Biedl syndrome (BBS), and POMC, PCSK1 or LEPR deficiency. IMCIVREE holds worldwide rights and is approved or authorized in the United States, EU, United Kingdom, Canada and other countries. Two earlier-stage MC4R agonists, oral bivamelagon and weekly subcutaneous RM-718, are in development and are designed to spare MC1R and not induce hyperpigmentation. The company has generated approximately $422.5 million of revenue from product sales to date.

Revenue drivers

• IMCIVREE U.S. sales — U.S. revenue was $51.0 million in Q2 2026, or 72% of product revenue, up 38% sequentially, driven by demand in acquired hypothalamic obesity following FDA approval on March 19, 2026 and continued BBS demand.
• IMCIVREE ex-U.S. sales — Ex-U.S. revenue was $20.3 million in Q2 2026, or 28% of product revenue, down 13% sequentially, reflecting a $3.8 million retrospective France Contribution M charge of which $3.1 million related to prior periods.
• Acquired hypothalamic obesity launch — Newest approved indication; more than 400 patient start forms from approximately 300 prescribers were received as of June 30, 2026, since the March 19, 2026 FDA approval.

Recent performance

Q2 2026 net product revenue from global IMCIVREE sales was $71.3 million, up 19% sequentially from Q1 2026 and up from $60.1 million in Q1 2026 and $57.3 million in Q4 2025. U.S. revenue of $51.0 million rose $14.1 million or 38% sequentially, while ex-U.S. revenue of $20.3 million fell $2.9 million or 13%, in part due to a $3.8 million retrospective France Contribution M charge. The number of patients on reimbursed therapy globally increased by more than 20% versus Q1 2026. Full-year revenue grew from $77.4 million in 2023 to $130.1 million in 2024 and $189.8 million in 2025, while operating cash flow remained negative at $115.7 million in 2025.

Strategy

Management is prioritizing the U.S. launch of IMCIVREE in acquired hypothalamic obesity, with more than 400 start forms since FDA approval as of June 30, 2026, and upcoming launches in Japan and Europe. The company is expanding the label toward congenital hypothalamic obesity through an independent substudy, with enrollment of first patients expected complete in the second half of 2026. It plans a Phase 3 registrational trial of oral bivamelagon in hypothalamic obesity by year-end 2026 and is evaluating RM-718 in an ongoing Phase 1/2 trial in acquired HO. It also reported positive Phase 2 results for setmelanotide in Prader-Willi syndrome and positive RM-718 results in acquired HO. Six abstracts, including three oral presentations, were accepted for ESPE 2026.

Risks

• Continued losses and no profitability — Rhythm has incurred significant operating losses since inception, anticipates continued losses for the foreseeable future, and may never achieve profitability.
• Limited commercial history — The company first commercialized IMCIVREE in the U.S. in Q1 2021, giving it a limited operating history on which to base commercial and financial expectations.
• Early-stage commercial expansion — Rhythm is in the early stages of commercializing IMCIVREE in its approved indications in the United States, Canada, EU and United Kingdom while pursuing additional indications.
• Ex-U.S. revenue variability — Ex-U.S. product revenue declined 13% sequentially in Q2 2026, partly due to a $3.8 million retrospective France Contribution M charge, of which $3.1 million related to earlier periods.

Outlook

Management expects pending regulatory approval to launch IMCIVREE in the United States as the first therapy specifically for acquired hypothalamic obesity, with launches in Japan and Europe upcoming. It estimates approximately 10,000 U.S. patients with acquired hypothalamic obesity, 500 new U.S. cases annually, similar prevalence and incidence in Europe, and between 5,000 and 8,000 patients in Japan. The company plans to initiate a Phase 3 registrational trial of bivamelagon in hypothalamic obesity by year-end 2026 and to complete enrollment of a congenital hypothalamic obesity substudy in the second half of 2026. Management cites strong U.S. commercial execution and a pipeline of MC4R agonists as the basis for long-term growth.