Rhythm Pharmaceuticals Reports Third Quarter 2025 Financial Results and Business Update

Core Insights - Rhythm Pharmaceuticals reported continued momentum in the third quarter of 2025, highlighted by FDA acceptance of the supplemental new drug application (sNDA) for acquired hypothalamic obesity and steady growth from Bardet-Biedl syndrome (BBS) commercial efforts [2][5] Financial Performance - Revenue from global sales of IMCIVREE (setmelanotide) was $51.3 million for Q3 2025, a 6% increase from Q2 2025, primarily driven by growth in patients and sales for BBS treatment [3][9] - U.S. revenue accounted for $38.2 million (74% of product revenue), marking a 19% sequential increase, while international revenue was $13.1 million (26% of product revenue), reflecting a 21% decrease [3][9] - The company recorded a one-time charge of $3.2 million in Q3 2025 due to a final reimbursed price agreement for IMCIVREE in France [3][9] - R&D expenses were $46.0 million in Q3 2025, up from $37.9 million in Q3 2024, mainly due to increased headcount and stock-based compensation [10] - SG&A expenses rose to $52.4 million in Q3 2025 from $35.4 million in Q3 2024, driven by higher costs associated with expanding operations and marketing [11] - The net loss attributable to common stockholders was $54.3 million for Q3 2025, compared to a net loss of $45.0 million in Q3 2024 [12] Clinical Developments - Rhythm expects to report preliminary results from the Phase 2 trial of setmelanotide in Prader-Willi syndrome in Q4 2025 [5][13] - A recent observational study indicated that setmelanotide treatment improved measures of metabolic dysfunction-associated steatotic liver disease (MASLD) and kidney function in BBS patients [6][7] Upcoming Milestones - The FDA's PDUFA goal date for the sNDA for setmelanotide in acquired hypothalamic obesity is set for December 20, 2025 [5][7] - The company anticipates completing enrollment in the Phase 1 trial evaluating RM-718 in Q1 2026 and announcing topline data from various ongoing trials in early 2026 [13] Cash Position - As of September 30, 2025, the company had approximately $416.1 million in cash, cash equivalents, and short-term investments, compared to $320.6 million at the end of 2024 [8][20]