Rhythm Pharmaceuticals, Inc. · NASDAQ:RYTM
Rhythm Pharmaceuticals — Q3 2025 Earnings Presentation
23 slides from Rhythm Pharmaceuticals's earnings presentation, Nov 4, 2025
Slide 1: Third Quarter 2025 Financial Results and Business Update
Rhythm Pharmaceuticals Third Quarter 2025 Financial Results and Business Update November 4, 2025 ® © Rhythm® Pharmaceuticals, Inc. All rights reserved.
Slide 2: On Today's Call
On Today’s Call • 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 •
Slide 3: Forward-looking Statements
Forward-looking Statements This presentation and the accompanying oral presentation contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matters of historical fact should be
Slide 4: David Meeker, MD
David Meeker, MD Chair, President and CEO ® 4
Slide 5: Well Positioned to Deliver Long-term, Sustained Growth: Q3'25 Highlights
Well Positioned to Deliver Long-term, Sustained Growth Q3’25 Highlights Steady growth in global IMCIVREE® (setmelanotide) sales in Q3 2025 primarily driven by Bardet-Biedl syndrome sNDA for setmelanotide in acquired hypothalamic obesity (HO) accepted by FDA for Priority Review with PDUFA goal date o
Slide 6: German Observational Study: Setmelanotide Improved MASLD, Kidney Function in BBS
German Investigator-led Observational Study Showed Setmelanotide associated with Improvement in Measures of MASLD, Kidney Function in Patients with BBS 26 patients with BBS completed six months on setmelanotide therapy. 100% >80% of patients (N=26) with of patients exhibited both BBS and metabolic e
Slide 7: Rhythm is Ready for a Successful U.S. Launch in Hypothalamic Obesity
Rhythm is Ready for a Successful U.S. Launch in Hypothalamic Obesity PDUFA goal date of December 20, 2025 Setmelanotide’s Transformative Significant opportunity demonstrated unmet need efficacy ~10,000 estimated U.S. prevalence1 1. U.S. estimates based on reported incidence of hypothalamic obesity f
Slide 8: Multiple Anticipated Milestones
Multiple Anticipated Milestones PDUFA goal date for setmelanotide in conditions associated with acquired Dec. 20, 2025 hypothalamic obesity Disclose preliminary results from exploratory Ph2 Prader-Willi trial Q4 2025 evaluating setmelanotide Complete enrollment in Part C of Ph1 trial evaluating RM-7
Slide 9: Jennifer Lee
Jennifer Lee EVP, Head of North America ® 9
Slide 10: Steady Growth in BBS Commercial Performance Continued in Q3
Steady Growth in BBS Commercial Performance Continued in Q3 Increase in Increased patients on breadth and depth IMCIVREE of prescribers Disease Clinical Decision Rx Education Suspicion Diagnosis to Treat IMCIVREE Access Maintenance ® 10
Slide 11: Strategic Priorities for IMCIVREE Launch in Acquired Hypothalamic Obesity
Strategic Priorities for IMCIVREE Launch in Acquired Hypothalamic Obesity, if approved PDUFA goal date of December 20, 2025 Differentiating Expediting Establishing Securing MC4R pathway patient IMCIVREE as the market access diseases diagnosis foundational treatment upon approval ® 11
Slide 12: Claims Analysis to Inform Physician Targeting
Claims Analysis to Inform Physician Targeting Patients with…. Tumor + Hypothalamic Endo visit ~5,000 treatment dysfunction Obesity within 18 months Endos potentially caring for a patient with acquired HO ~2,400 Top target physicians ® 12
Slide 13: Patient Identification through Physician Profiling
Patient Identification through Physician Profiling >2,000 Field teams prioritize top tier physicians IDed through potential patients claims analysis Suspected to have…. or… diagnosed with Ongoing efforts profiling physicians acquired hypothalamic obesity ® 13
Slide 14: Ready to Launch!
Ready to Launch! PDUFA goal date of December 20, 2025 Patient services team Access team Territory managers engaging with engaging with payers engaging with HCPs patients, families ® 14
Slide 15: Yann Mazabraud
Yann Mazabraud EVP, Head of International ® 15
Slide 16: IMCIVREE available in >25 countries outside the United States
IMCIVREE available in >25 countries outside the United States Continued execution Ongoing BBS, POMC/LEPR sales Final agreement on French price Early-access acquired HO programs in France and Italy Named patient sales ® 16
Slide 17: Advancing Setmelanotide towards European Launches for Acquired Hypothalamic Obesity
Advancing Setmelanotide towards European Launches for Acquired Hypothalamic Obesity ✓ EMA Submission CHMP Opinion ~10,000 EMA Authorization estimated European prevalence1 Country-by-country Negotiations 1. European estimates limited to the EU4 (Germany, France, Spain, Italy), UK and the Netherlands
Slide 18: Building Team in Japan to Support Regulatory Submission, Potential Launch
Building Team in Japan to Support Regulatory Submission, Potential Launch Experienced team in place: • Regulatory 5,000 – 8,000 • • Quality CMC estimated Japanese • Medical affairs prevalence1 • Market access • Marketing • General Management 1. Rhythm estimates the prevalence of acquired hypothalami
Slide 19: Hunter Smith
Hunter Smith Chief Financial Officer ® 19
Slide 20: Q2 to Q3 '25: Consistent Growth in Patient Demand Continues in U.S. and ex-U.S.
Q2 to Q3 ’25: Consistent Growth in Patient Demand Continues in U.S. and ex-U.S. 10% growth in patients on reimbursed therapy globally QoQ $3.7M $2.5M $51.3M $48.5M -$3.4M Q2 2025 Q2-Q3 inventory effect at U.S. Revenue growth from $3.2M of $3.4M QoQ decrease in ex-US Q3 2025 Product product dispensed
Slide 21: Q3 2025 Financial Snapshot
Q3 2025 Financial Snapshot ($ in millions, except per share Three months ended Three months ended data and shares outstanding) September 30, 2025 September 30, 2024 Product revenue, net $51.3M $33.3M R&D expenses $46.0M $37.9M SG&A expenses $52.4M $35.4M Net Loss attributable to common stockholders
Slide 22: Operating Expenses in Q3 '25; Updated Full-Year Guidance
Operating Expenses in Q3 ‘25; Updated Full-Year Guidance Q3 ‘25 OpEx 2025 OpEx Guidance $295M to $315M $98.5M anticipated non-GAAP Operating Q3 2025 OpEx Expenses* for 2025 includes: includes R&D: $150M to $165M $18.8M $40M LGC in-license milestone paid in July 2025 accounted for as R&D expense in 2
Slide 23: Questions
Questions Rhythm
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