Rhythm Pharmaceuticals (NasdaqGM:RYTM) Q4 2025 Earnings call February 26, 2026 08:00 AM ET Operator Good day. Thank you for standing by. Welcome to the Rhythm Pharmaceuticals fourth quarter and fiscal year 2025 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during this session, you will need to press star one one on your telephone. You will then hear an automated message advi ...

Rhythm Pharmaceuticals (NasdaqGM:RYTM) Q4 2025 Earnings call February 26, 2026 08:00 AM ET Company ParticipantsCorinne Johnson - Managing DirectorDave Connolly - Head of Investor Relations and Corporate CommunicationsDavid Meeker - Chairman, CEO, and PresidentDerek Archila - Managing Director and Co-Head of Therapeutics ResearchHunter Smith - CFOJennifer Lee - EVP and Head of North AmericaJon Wolleben - Managing DirectorTazeen Ahmad - Managing DirectorYann Mazabraud - EVP and Head of InternationalConference ...

On Today's Call Rhythm Pharmaceuticals Fourth Quarter and Year End 2025 Financial Results and Business Update February 26, 2026 ® © Rhythm® Pharmaceuticals, Inc. All rights reserved. ® 2 • David Connolly, Executive Director of Investor Relations and Corporate Communications • David Meeker, MD, Chair, President and Chief Executive Officer • Jennifer Lee, Executive Vice President, Head of North America • Yann Mazabraud, Executive Vice President, Head of International • Hunter Smith, Chief Financial Officer Fo ...

-- Fourth quarter 2025 net product revenue from global sales of IMCIVREE® (setmelanotide) of $57.3 million -- -- March 20, 2026 PDUFA goal date for sNDA for setmelanotide in acquired hypothalamic obesity (HO) ---- Phase 2 open-label extension data showed bivamelagon achieved persistent BMI reductions at six and nine months; Completed positive end-of-Phase-2 meeting with FDA ---- On track to report topline data from 12-patient Japanese cohort of setmelanotide Phase 3 trial in acquired HO in March 2026 -- -- ...

RBC Capital Markets initiated coverage on Rhythm Pharmaceuticals Inc. (NASDAQ:RYTM) , citing it as a commercial-stage biotech pioneering the rare genetic obesity market.Analyst Lisa Walter wrote on Wednesday that Rhythm Pharmaceuticals’ Phase 3 success in hypothalamic obesity (HO) in 2025 led to a stock rally and a ~$3.5 billion market-cap gain.Hypothalamic obesity is a rare type of obesity resulting from damage to the hypothalamus, a brain region that regulates appetite and metabolism.Rare Obesity Opportun ...

BOSTON, Feb. 17, 2026 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that it will host a live conference call and webcast at 8 a.m. ET on Thursday, February 26, 2026 to report its fourth quarter and full year 2025 financial results and provide a corporate update. To access the live conference call, participants may register here. While ...

Rhythm Pharmaceuticals Conference Call Summary Company Overview - **Company**: Rhythm Pharmaceuticals (NasdaqGM:RYTM) - **Focus**: Treatment of rare neuroendocrine disorders, specifically targeting the MC4R pathway - **Key Product**: IMCIVREE (setmelanotide), the first approved agonist of the MC4R pathway, with three current indications and a fourth pending approval for hypothalamic obesity (HO) on March 20, 2026 [2][3] Core Points and Arguments Product and Pipeline - IMCIVREE is approved for three indications, with a significant upcoming indication for hypothalamic obesity [2] - Recent interim phase 2 data in Prader-Willi syndrome shows promise [3] - Two additional pipeline compounds: - Bivamelagon (oral small molecule MC4R agonist) - RM-718 (weekly injectable therapy) [3] Market Dynamics - **Sales Growth**: - $57 million in sales reported last quarter, with a 9% quarter-over-quarter growth for the bulk of the previous year [9] - 10% growth in reimbursed patients and a 7% increase in BBS prescriptions in Q4 [9] - **Patient Population**: - Targeting approximately 1,000 patients in the U.S. for BBS, with a potential peak sales opportunity of $300 million [12] - For HO, estimates suggest upwards of 10,000 patients in the U.S., indicating a larger market potential compared to BBS [13] Clinical Data - HO study showed a 16.5% reduction in BMI for patients on setmelanotide, with a placebo-adjusted difference of 19.8% at 52 weeks [20] - High response rates: 80% of patients had more than a 5% BMI reduction, and 60% had more than a 10% reduction [20] Commercial Strategy - Increased sales force from 16 to 42 representatives in anticipation of the HO PDUFA date [22] - Utilization of claims data to identify potential HO patients, with 2,000 suspected or diagnosed patients identified in targeted physician practices [24] - Challenges include physician awareness and the reimbursement process, particularly for Medicare patients [30] Regulatory and Development Updates - Delay in PDUFA due to additional analysis requested by the FDA regarding BMI Z scores for patients under 18 [36] - Ongoing studies in Prader-Willi syndrome, with interim data showing positive results for patients on setmelanotide [44] Other Important Considerations - The company is navigating the complexities of physician education regarding hypothalamic obesity, which is not widely understood among endocrinologists [26] - The potential impact of Medicare reimbursement policies on the launch trajectory for HO treatment [30] - Cash runway of approximately $418 million, providing at least 24 months of operational funding [51] This summary encapsulates the key insights from the Rhythm Pharmaceuticals conference call, highlighting the company's strategic focus, market opportunities, clinical data, and regulatory challenges.

BOSTON, Feb. 05, 2026 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that Hunter C. Smith, Chief Financial Officer, will participate in a fireside chat at the upcoming Guggenheim Emerging Outlook: Biotech Summit 2026 conference on Wednesday, February 11 at 11:00 a.m. ET in New York. The fireside chat will be webcasted and available unde ...

Core Insights - Rhythm Pharmaceuticals has experienced significant growth, outperforming major companies like Google and Nvidia over the past year, with a consensus price target indicating a potential upside of around 40% [1][2] - The company operates in the biotech sector with a market capitalization of $6.8 billion, focusing on therapies for rare genetic obesity disorders rather than high-profile conditions [4] Company Overview - Rhythm Pharmaceuticals' only approved drug is Imcivree, a first-in-class melanocortin-4 receptor (MC4R) agonist, which treats obesity due to specific genetic deficiencies and Bardet-Biedl syndrome, generating sales of approximately $194 million in 2025, reflecting a year-over-year increase of about 50% [5] - The company is advancing its pipeline with plans to move its oral MC4R agonist bivamelagon into Phase 3 clinical testing in 2026, alongside another candidate, RM-718, currently in Phase 1 testing [6] Competitive Landscape - Competition for Rhythm Pharmaceuticals is limited, with Palatin Technologies being the only notable rival developing MC4R agonists, but it is significantly behind in clinical testing [7] Upcoming Catalysts - Wall Street's optimism is bolstered by multiple upcoming catalysts, particularly the anticipated FDA approval of Imcivree for treating acquired hypothalamic obesity, with a PDUFA date set for March 20, 2026 [8] - Acquired hypothalamic obesity affects an estimated 10,000 patients in the U.S., with additional patient populations in Europe and Japan, representing a market opportunity that is at least 3.7 times larger than the current approved indications for Imcivree [9]

Financial Performance - Rhythm Pharmaceuticals reported preliminary unaudited net revenues of approximately $57 million for Q4 2025, an 11% increase sequentially from Q3 2025[7]. - Full-year 2025 net product revenues are expected to be around $194 million, a 50% increase compared to $130 million in 2024[7]. - U.S. sales of IMCIVREE accounted for approximately 68% of Q4 2025 net product revenues and about 69% of full-year 2025 revenues[7]. - The financial results presented are preliminary and subject to change pending the completion of financial closing and audit procedures[13]. Clinical Trials and Research - The company plans to complete enrollment in the Phase 3 trial substudy for congenital hypothalamic obesity in the first half of 2026[8]. - Topline data from the Phase 3 EMANATE trial for genetically caused MC4R pathway diseases is expected to be announced in Q1 2026[9]. - Positive preliminary data for the exploratory Phase 2 trial of setmelanotide in Prader-Willi Syndrome showed BMI and hyperphagia reductions at months 3 and 6[10]. - A pivotal Phase 3 trial for bivamelagon in acquired hypothalamic obesity is planned for 2026, pending regulatory feedback[11]. - Enrollment in the Phase 1 trial for RM-718 is expected to be completed in Q1 2026[12]. Product Launch and Approvals - The company anticipates launching IMCIVREE in the U.S. for acquired hypothalamic obesity pending FDA approval, with a PDUFA goal date of March 20, 2026[14].