Rhythm Pharmaceuticals Reports Q3 2025 Earnings, $51.3 M Revenue, and FDA Acceptance of sNDA for Hypothalamic Obesity

RYTM
November 04, 2025

Rhythm Pharmaceuticals reported third‑quarter 2025 net product revenue of $51.3 million, a 6 % sequential increase and a 54 % year‑over‑year rise from $33.3 million in Q3 2024. The company posted a net loss of $54.3 million, up from $45.0 million in the same quarter last year, and a net loss per share of $0.82.

U.S. sales accounted for $38.2 million (74 % of revenue) while international sales totaled $13.1 million (26 %). International revenue fell 21 % sequentially, driven by pricing adjustments in France and variable ordering patterns, including a one‑time $3.2 million price adjustment in that market.

R&D expenses were $46.0 million and SG&A costs were $52.4 million, higher than the prior quarter due to increased headcount, stock‑based compensation, and expanded marketing efforts for new indications.

Cash, cash equivalents, and short‑term investments stood at $416.1 million as of September 30 2025. Management reiterated guidance that non‑GAAP operating expenses for 2025 will be between $295 million and $315 million, supporting a cash runway of at least 24 months.

The FDA accepted Rhythm’s supplemental new drug application for acquired hypothalamic obesity, with a PDUFA goal date of December 20 2025. This milestone expands the indication for setmelanotide (IMCIVREE) and strengthens the company’s rare‑obesity portfolio.

Rhythm’s strategy centers on the MC4R pathway, with additional pipeline candidates in development. A Phase 2 trial of setmelanotide in Prader‑Willi syndrome is underway, with preliminary results expected in Q4 2025.

CEO Mark L. Smith expressed confidence in the company’s growth trajectory, noting headwinds such as international pricing pressure and ongoing investment in R&D, but emphasized the strong cash position and planned clinical milestones.

Rhythm will host an earnings conference call at 8:00 a.m. ET to discuss the results and outlook.

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