Rhythm(US:RYTM)2025-11-04 21:06Revenue and Sales Performance - IMCIVREE® (setmelanotide) generated net product revenue of $51.3 million in Q3 2025, a 6% increase sequentially from Q2 2025, with 74% of revenue ($38.2 million) coming from the U.S.[141] - Revenue from outside the U.S. was $13.1 million in Q3 2025, a 21% decrease sequentially, primarily due to changes in reimbursement pricing in France[141] - Product revenue increased by $18.0 million to $51.3 million for the three months ended September 30, 2025, representing a 54% increase compared to the same period in 2024[176] - For the nine months ended September 30, 2025, product revenue increased by $49.2 million to $137.5 million, a 56% increase compared to the same period in 2024[181] Clinical Trials and Research - The pivotal Phase 3 TRANSCEND trial for setmelanotide in acquired hypothalamic obesity met its primary endpoint, showing a statistically significant reduction in BMI[135] - Bivamelagon achieved statistically significant BMI reductions at 14 weeks in a Phase 2 trial for acquired hypothalamic obesity[138] - The company has a comprehensive clinical research program with multiple ongoing and planned trials for MC4R pathway diseases[137] - The company is advancing RM-718, a weekly-administered MC4R agonist, with enrollment in Phase 1 trials ongoing[146] - The company plans to complete enrollment in the Phase 1 trial for RM-718 in the first quarter of 2026[148] Financial Performance - The company reported a net loss of $52.9 million for the three months ended September 30, 2025, and $149.0 million for the nine months ended September 30, 2025[153] - As of September 30, 2025, the company had an accumulated deficit of $1.3 billion[153] - Research and development expenses for the three months ended September 30, 2025, were $46.0 million, compared to $37.9 million for the same period in 2024[163] - Selling, general and administrative expenses for the three months ended September 30, 2025, were $52.4 million, up from $35.4 million in 2024[171] - Net loss for the three months ended September 30, 2025, was $52.9 million, compared to a net loss of $43.6 million in the same period in 2024, representing a 21% increase in losses[176] - The net loss for the nine months ended September 30, 2025, was $149.0 million, adjusted for non-cash items totaling $59.0 million, while for 2024, the net loss was $217.3 million with non-cash adjustments of $121.9 million[189][190] Cash and Funding - Cash and cash equivalents as of September 30, 2025, were approximately $416.1 million, expected to fund operations for at least 24 months[155] - The company closed a public offering of 2,367,647 shares at $85 per share, resulting in net proceeds of approximately $188.7 million[142] - Net cash used in operating activities for the nine months ended September 30, 2025, was $90.3 million, compared to $95.0 million for the same period in 2024, reflecting a decrease of 7.8%[189][190] - Net cash used in investing activities was $167.5 million for the nine months ended September 30, 2025, primarily due to purchases of short-term investments totaling $328.3 million, offset by maturities of $200.8 million[191] - Net cash provided by financing activities was $220.9 million for the nine months ended September 30, 2025, driven by net proceeds of $188.7 million from a follow-on offering[193] - The company expects its cash and cash equivalents as of September 30, 2025, to be sufficient to fund operations for at least 24 months[195] - The company may need to obtain substantial additional funding for research and development activities and ongoing operations[196] Regulatory and Market Developments - The U.S. FDA accepted the supplemental New Drug Application for setmelanotide for hypothalamic obesity, granting Priority Review with a PDUFA goal date of December 20, 2025[136] - The company anticipates a decision from the FDA on its sNDA for setmelanotide by December 20, 2025[148] - The company has built its marketing and commercial sales infrastructure in the U.S. and is expanding in Europe and the UK[149] - The global economic environment has experienced volatility, which could impact the company's liquidity and future funding requirements[199] Market Potential - Approximately 10,000 people in the U.S. are estimated to have hypothalamic obesity, with similar estimates of 5,000 to 8,000 in Japan and 10,000 in the E.U.[136] - The company estimates approximately 29,000 U.S. patients with genetically driven obesity could respond well to setmelanotide[140] - The company anticipates significant commercialization expenses related to product sales, marketing, manufacturing, and distribution as it continues clinical development and seeks marketing approval for setmelanotide[194]