Rhythm Pharmaceuticals (RYTM) FY Conference June 09, 2025 08:00 AM ET Speaker0 morning, everyone, and welcome to the Goldman Sachs Healthcare Conference. We're thrilled to have David Meeker, the CEO of them, here today joining us. Before we get started, we are required to make certain disclosures and public experiences about Goldman Sachs relationships with companies that we discuss. The disclosures relate to investment banking relationships, compensation received, or 1% or more ownership. We are prepared t ...

Rhythm Pharmaceuticals (RYTM) 2025 Conference June 04, 2025 03:10 PM ET Speaker0 Okay. Yeah. Hi. Hi, good afternoon. Welcome to day one of the Jefferies Healthcare Conference. My name is Dennis Ting, biotech analyst here at Jefferies. I have the great pleasure of having CEO David Meeker here with us from Rhythm Pharmaceuticals. Welcome. Speaker1 Yeah. Thanks, Dennis. Speaker0 So perhaps just level set us in terms of where the company is today and just sort of the evolution of the company since over the last ...

Rhythm Pharmaceuticals (RYTM) 2025 Conference May 14, 2025 12:20 PM ET Speaker0 Much for joining us. My name is Joanna Gajuk. I cover health care facilities managed care of America. Thanks so much for joining the conference and the session. So now a pleasure to to have Addus Home Care, so I'm pretty sure they would ask. They're one of the largest or maybe the largest provider of personal care services in The U. S, but they also do other things. We can talk about that. But today, we'd actually have an entire ...

-- New data showed setmelanotide achieved consistent, meaningful weight reduction -- -- Multiple presentations delivered at the first-ever Joint Congress between the European Society for Paediatric Endocrinology and the European Society of Endocrinology (ESPE-ESE); 32nd annual European Congress on Obesity (ECO); and the 2025 annual meeting of the Pediatric Endocrine Society (PES 2025) -- BOSTON, May 14, 2025 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharm ...

Financial Performance - IMCIVREE generated $37.7 million in global sales for Q1 2025, with a 14% increase in the number of patients on reimbursed therapy compared to Q4 2024[145]. - U.S. revenue for IMCIVREE was $24.5 million, accounting for 65% of product revenue, despite an $8.3 million decrease in inventory at specialty pharmacies[145]. - IMCIVREE generated approximately $265.3 million in product revenue since its launch, with net product revenue of $37.7 million for the three months ended March 31, 2025, representing a 45% increase from $26.0 million in the same period of 2024[158][173]. - The company reported a net loss of $49.5 million for the three months ended March 31, 2025, a 65% improvement compared to a net loss of $141.4 million for the same period in 2024[154][173]. - As of March 31, 2025, the company had an accumulated deficit of $1.2 billion and existing cash and cash equivalents of approximately $314.5 million, expected to fund operations into 2027[154][156]. - Research and development expenses decreased by 71% to $37.0 million for the three months ended March 31, 2025, compared to $128.7 million for the same period in 2024[163][173]. - Selling, general, and administrative expenses increased by 14% to $39.1 million for the three months ended March 31, 2025, compared to $34.4 million for the same period in 2024[170][173]. - Cost of sales increased by 30% to $3.6 million for the three months ended March 31, 2025, compared to $2.8 million for the same period in 2024[173]. - Net cash used in operating activities was $40.4 million for the three months ended March 31, 2025, primarily due to a net loss of $49.5 million adjusted for non-cash items[183]. - Net cash provided by investing activities was $24.8 million for the three months ended March 31, 2025, related to gross maturities of short-term investments of $58.3 million[185]. - Net cash provided by financing activities was $32.5 million for the three months ended March 31, 2025, consisting of net proceeds of $34.0 million from an ATM equity offering[187]. - The company sold approximately two million shares in the ATM Program for net proceeds of approximately $48.9 million between August 10, 2023, and August 21, 2023[198]. Clinical Trials and Research - The pivotal Phase 3 TRANSCEND trial showed a -19.8% placebo-adjusted BMI reduction with setmelanotide in patients with acquired hypothalamic obesity, achieving a mean BMI change of -16.5% for treated patients[145][146]. - The company has a comprehensive clinical research program with multiple ongoing and planned trials for MC4R pathway diseases, including RM-718 and bivamelagon[142][143]. - The Phase 2 trial of bivamelagon is expected to announce topline data in Q3 2025[150]. - The Phase 3 EMANATE trial is ongoing, evaluating setmelanotide in genetically caused MC4R pathway diseases, with topline data expected in Q1 2026[150]. - The company is leveraging a DNA database of approximately 100,000 samples to enhance understanding and treatment of severe obesity related to MC4R pathway deficiencies[144]. - The company anticipates significant increases in research and development costs as clinical trials for setmelanotide and other product candidates progress[167]. - The company anticipates increased expenses related to ongoing clinical development and commercialization efforts[189]. Market Access and Regulatory Plans - The company plans to submit a supplemental New Drug Application to the FDA and a Type II variation request to the European Medicines Agency for setmelanotide in Q3 2025[150]. - The company has achieved market access for IMCIVREE in over 15 countries outside the United States and continues to pursue additional market access[173]. - The company reacquired rights to IMCIVREE in China, including Hong Kong and Macau, after terminating a licensing agreement[147]. Inventory and Revenue Adjustments - A reduction of previously recognized license revenue of $5.0 million was recorded due to the termination of an exclusive license agreement with RareStone[159][174].

Rhythm Pharmaceuticals, Inc. (RYTM) came out with a quarterly loss of $0.81 per share versus the Zacks Consensus Estimate of a loss of $0.69. This compares to loss of $2.35 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -17.39%. A quarter ago, it was expected that this company would post a loss of $0.69 per share when it actually produced a loss of $0.72, delivering a surprise of -4.35%.Over the last four quarters, the compan ...

Rhythm Pharmaceuticals (RYTM) Q1 2025 Earnings Call May 07, 2025 08:00 AM ET Company Participants David Connolly - Executive Director, Investor Relations and Corporate CommunicationsDavid Meeker - Chairman, President & CEOJennifer Lee - Executive Vice President, Head of North AmericaYann Mazabraud - Executive VP & Head of InternationalHunter Smith - Chief Financial OfficerJon Wolleben - Managing DirectorTazeen Ahmad - MD - US Equity ResearchSeamus Fernandez - Senior Managing DirectorWhitney Ijem - Managing ...

Rhythm Pharmaceuticals (RYTM) Q1 2025 Earnings Call May 07, 2025 08:00 AM ET Speaker0 Good day and thank you for standing by. Welcome to the Rhythm Pharmaceuticals First Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. Please be advised that today's conference is being recorded. After the speakers' presentation, there will be a question and answer session. I would now like to hand the conference over to your speaker today, David Connolly, Investo ...

Rhythm Pharmaceuticals First Quarter 2025 Financial Results and Business Update May 7, 2025 ® © Rhythm® Pharmaceuticals, Inc. All rights reserved. On Today's Call ® 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 Forward-looking Statem ...

EXHIBIT 99.1 Rhythm Pharmaceuticals Reports First Quarter 2025 Financial Results and Business Update -- First quarter 2025 net product revenue from global sales of IMCIVREE® (setmelanotide) of $37.7 million -- -- Setmelanotide pivotal Phase 3 TRANSCEND trial met primary endpoint with -19.8% placebo-adjusted BMI reduction in patients (N=120) with acquired hypothalamic obesity -- -- U.S. and EU regulatory submissions for setmelanotide in acquired hypothalamic obesity on track to be completed in the third quar ...