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What were the key takeaways from Rhythm's earnings call?

- **Q3 Momentum**: 10% global patient growth on IMCIVREE, $51.3M revenue, $416M cash runway
- **Upcoming Milestones**: HO FDA PDUFA 12/20, PWS Phase II data Q1 2026, Japan NDA submission
- **Strategic Focus**: MC4R pathway expansion into acquired obesity, international launches 2027
- **Operational Strength**: 84% U.S. gross-to-net, disciplined R&D/S&G spend


**【CEO Summary Section】**
- CEO David Meeker highlighted Q3 progress, including 10% global patient growth on IMCIVREE and preparations for the December 20 HO launch. He emphasized the MC4R pathway's therapeutic potential for rare obesity disorders.
- CEO outlined upcoming milestones: Phase II PWS top-line data release in Q1 2026 and Phase III HO trial initiation in 2026. He noted FDA feedback aligns with a 5% BMI change threshold for Phase III design.

**【CFO Financial Commentary】**
- CFO Hunter Smith reported Q3 revenue of $51.3M (10% patient growth), with $38.2M (74%) from U.S. sales. Cash balance of $416M provides >24-month runway. R&D/S&G expenses totaled $98.5M, supporting HO launch readiness.
- CFO emphasized financial discipline, with 84% gross-to-net in the U.S. and 74% international revenue from early access programs.

**【Q&A Highlights】**
- **Trial Design Clarity**: CEO provided details on the Phase III HO trial (52-week double-blind, 10-20 patient cohort) and FDA feedback on BMI change metrics.
- **Reimbursement Strategy**: Jennifer Chien outlined payer engagement for acquired HO, with 2,000 target physicians and 2,000 potential patients identified through claims analysis.
- **International Launch Timing**: Yann Mazabraud detailed Europe and Japan timelines (2027), leveraging existing BBS infrastructure.
- **PWS Observational Data**: CEO highlighted liver function improvements in BBS patients, suggesting broader MC4R benefits.


Rhythm Pharmaceuticals, Inc. (RYTM) Q3 2025 Earnings Call Transcript

Revenue

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RYTM

RYTM fundamentals

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