0001628280-26-030136
SEC filingRhythm Pharmaceuticals reports Q1 2026 IMCIVREE revenue of $60.1M and net loss of $(56.7)M, with FDA approval for acquired hypothalamic obesity driving strong launch.
Rhythm Pharmaceuticals reported first quarter 2026 financial results, highlighting a strong launch of IMCIVREE for acquired hypothalamic obesity (HO) following FDA approval on March 19, 2026. Net product revenue reached $60.1 million, a 5% sequential increase from Q4 2025, driven primarily by Bardet-Biedl syndrome (BBS) sales and growth in reimbursed patients globally. U.S. revenue of $36.9 million declined 5% sequentially due to specialty pharmacy inventory dynamics and patients transitioning insurance plans, while ex-U.S. revenue of $23.2 million grew 27% sequentially. The company received over 150 patient start forms for IMCIVREE in acquired HO within the first six weeks post-approval, indicating strong initial demand. Additionally, the European Commission granted Marketing Authorization for acquired HO on May 1, 2026, with country-level launches expected in 2027. In Japan, the NDA for setmelanotide in acquired HO is under PMDA review, with a decision anticipated in H2 2026 and potential launch by year-end. R&D expenses increased to $41.7 million from $37.0 million year-over-year, primarily due to higher headcount partially offset by lower clinical trial and manufacturing costs. SG&A expenses rose to $63.6 million from $39.1 million, driven by increased headcount and marketing to support revenue growth. Net loss widened to $(56.7) million ($(0.83) per share) from $(50.8) million ($(0.81) per share) in Q1 2025. The company provided full-year 2026 Non-GAAP operating expense guidance of $385-$415 million, with R&D of $197-$213 million and SG&A of $188-$202 million, excluding stock-based compensation. Cash, cash equivalents, and short-term investments totaled $340.6 million as of March 31, 2026, expected to fund operations for at least 24 months. Management highlighted upcoming milestones including Phase 2 data for setmelanotide in Prader-Willi syndrome in Q2 2026, Phase 1/2 data for RM-718 in acquired HO mid-2026, and initiation of a pivotal Phase 3 trial for bivamelagon in acquired HO by year-end 2026.