Rhythm's U.S. IMCIVREE Sales Rebound After a First-Quarter Dip
Global IMCIVREE net product revenue reached $71.3 million in the second quarter as U.S. sales rose 38% sequentially.
Rhythm Pharmaceuticals (RYTM), a commercial-stage biopharmaceutical company focused on rare neuroendocrine diseases, reported second-quarter IMCIVREE net product revenue of $71.3 million, up 19% sequentially from $60.1 million in the first quarter after a 5% sequential increase in the first quarter from $57.3 million in the fourth quarter of 2025.
The sequential acceleration was concentrated in the United States. U.S. product revenue was $51.0 million, or 72% of the total, up $14.1 million, or 38%, from $36.9 million in the first quarter. That followed a 5% sequential decline in the first quarter from $39.0 million in the fourth quarter of 2025. The U.S. rebound was driven primarily by increased patient demand for IMCIVREE in acquired hypothalamic obesity (HO), as well as continued growth in demand in Bardet-Biedl syndrome.
FDA approval of IMCIVREE for acquired HO on March 19, 2026, had not yet been fully reflected in first-quarter U.S. sales, when specialty-pharmacy inventory and insurance transitions weighed on the U.S. mix. By June 30, more than 400 patient start forms had been received from approximately 300 prescribers, versus more than 150 in the first six weeks after approval. The number of patients on reimbursed therapy globally increased by more than 20% compared with the first quarter.
Outside the United States, product revenue was $20.3 million, or 28% of the total, down $2.9 million, or 13%, from $23.2 million in the first quarter. The company incurred a $3.8 million retrospective charge associated with the Contribution M mechanism in France, of which $3.1 million related to revenue booked in periods before the second quarter. Reimbursed patients on IMCIVREE continued to increase in the second quarter.
Net loss attributable to common stockholders was $50.4 million, or $0.73 a share, in the second quarter of 2026, versus $48.0 million, or $0.75 a share, a year earlier. Selling, general and administrative expenses were $67.4 million, versus $45.9 million a year earlier, primarily due to increased personnel costs, including stock-based compensation, related to expanded business operations. Research and development expenses were $43.4 million, versus $42.3 million a year earlier, primarily due to personnel costs, genetic-testing data analytics, preclinical expense and bivamelagon trials, partially offset by lower chemistry, manufacturing and controls activity and clinical-trial costs as the EMANATE and TRANSCEND Phase 3 trials wound down.
Cash, cash equivalents and short-term investments were approximately $330.9 million as of June 30, 2026, compared with $388.9 million as of December 31, 2025. For the year ending December 31, 2026, Rhythm anticipates approximately $363 million to $397 million in Non-GAAP operating expenses, including R&D of approximately $175 million to $195 million and SG&A of approximately $188 million to $202 million. Based on current operating plans, the company expects that cash as of June 30, 2026, will be sufficient to fund planned operations for at least 24 months.
Clinical and commercial milestones remain the next inflection point. The company expects to complete enrollment in the setmelanotide substudy in congenital HO and in Phase 1/2 Part D of RM-718 in Prader-Willi syndrome in the second half of 2026, to initiate a pivotal Phase 3 trial of bivamelagon in acquired HO by year-end 2026, and to anticipate country-level launches of IMCIVREE for acquired HO in Europe beginning in 2027. A Japan launch for acquired HO is anticipated pending a decision by Japan’s Ministry of Health, Labour and Welfare by year-end 2026.
During the quarter, the company also published Phase 3 TRANSCEND results in acquired HO in the New England Journal of Medicine and presented six-month Phase 2 setmelanotide data in Prader-Willi syndrome, as well as preliminary Part C results for weekly injectable RM-718, which achieved a mean BMI reduction of 11.6% in seven acquired-HO patients after 16 weeks. Chairman, Chief Executive Officer and President David Meeker said the company remained focused on expanding treatment options and realizing the potential of its MC4R agonist pipeline as U.S. commercial execution continued and launches in Japan and Europe approached.