Rhythm's IMCIVREE Sales Growth Accelerates to 29%

The Tip Desk · November 3, 2026 · 4 min read

Net product revenue from global IMCIVREE sales reached $92.1 million in the third quarter, and the company entered a five-year term-loan facility providing access to up to $750 million.

Rhythm Pharmaceuticals (RYTM), a commercial-stage biopharmaceutical company focused on rare neuroendocrine diseases, reported net product revenue from global sales of IMCIVREE (setmelanotide) of $92.1 million for the third quarter ended September 30, 2026, up 29% from $71.3 million in the second quarter. Sequential growth accelerated from 19% in the prior quarter.

The company said more than 700 patient start forms for IMCIVREE in acquired hypothalamic obesity had been received from more than 500 prescribers as of September 30, 2026, after FDA approval on March 19, 2026, versus more than 400 start forms from about 300 prescribers as of June 30. Patients on reimbursed therapy globally increased 20% versus the second quarter.

U.S. product revenue was $67.5 million, or 73% of product revenue, up $16.5 million, or 32%, from $51.0 million in the second quarter. The company attributed the sequential increase primarily to higher patient demand for IMCIVREE in acquired HO and continued growth in Bardet-Biedl syndrome. U.S. sequential growth slowed from 38% in the second quarter.

Ex-U.S. product revenue was $24.7 million, or 27% of product revenue, up $4.4 million, or 22%, from $20.3 million. That reversed a 13% sequential decline in the second quarter that included a $3.8 million France Contribution M charge. The company said the number of reimbursed patients on IMCIVREE continued to increase.

On October 13, 2026, Rhythm commercially launched IMCIVREE in Japan for acquired HO after Japan’s Ministry of Health, Labour and Welfare approved the drug on August 24. Health Canada approved IMCIVREE on September 22 for weight management in adult and pediatric patients 4 years and older with acquired HO. Chairman, Chief Executive Officer and President David Meeker said Japan “represents another important milestone in a market with the potential to become our second largest.”

Net loss attributable to common stockholders was $42.4 million, or $0.61 a share, compared with $54.3 million, or $0.82 a share, in the third quarter of 2025. Cost of sales was $12.2 million. Research and development expenses were $52.5 million; the company said the year-over-year increase was primarily due to higher chemistry, manufacturing, and controls and clinical-trial costs, personnel costs, and a development milestone in congenital hyperinsulinism. Selling, general, and administrative expenses were $66.8 million, which the company attributed primarily to higher personnel costs, including stock-based compensation, related to expanded operations.

On November 2, 2026, Rhythm amended its exclusive license with LG Chem for bivamelagon. Under the amendment, Rhythm agreed to pay $350 million in fixed payments over four years to reduce the original low-to-mid single-digit royalty to 1% on net product revenue generated by its MC4R portfolio. The same day it entered a five-year term loan facility led by KKR’s HealthCare Royalty in partnership with Blackstone Life Sciences, providing access to up to $750 million, and entered an amended and restated Revenue Interest Financing Agreement with Health Care Royalty.

Cash, cash equivalents and short-term investments were approximately $320.9 million as of September 30, 2026, compared with $388.9 million as of December 31, 2025. That cash position does not include a $250 million initial draw on the term loan or a $70 million payment due to LG Chem under the amendment.

Rhythm said it expects to initiate a pivotal Phase 3 trial of bivamelagon in acquired HO by year-end 2026, complete enrollment in a Phase 1/2 Part D trial of RM-718 in Prader-Willi syndrome in the second half of 2026, and begin country-level IMCIVREE launches in Europe beginning with Germany in 2027. For the year ending December 31, 2026, it anticipates approximately $360 million to $380 million in Non-GAAP operating expenses, including R&D of approximately $165 million to $175 million and SG&A of approximately $195 million to $205 million. Based on current operating plans, the company said cash as of September 30, 2026 will fund planned operations for at least 24 months.