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- **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 Growth & Cash Strength**: Q2 2025 revenue $48.5M (+29% QoQ), $189M equity raise provides >24-month cash runway.
- **Clinical Milestones**: Setmelanotide Phase III in HO shows 19.8% BMI reduction vs placebo; bivamelagon Phase II -9.7% BMI at 12 weeks.
- **Pipeline Expansion**: Targeting 2026 Phase III for bivamelagon and EMANATE trial; Japan team building for 2026 filings.
- **Financial Discipline**: Non-GAAP OpEx $285-315M, R&D/Sales & Marketing up 14%/18% QoQ.
- **Risk Points**: Prader-Willi Phase II 50-50 success odds; minimal U.S. HO off-label use.

**【CEO Summary Section】**
- Rhythm reported strong Q2 2025 performance with global revenue of $48.5 million, up 29% QoQ, driven by BBS and early access HO sales.
- CEO David Meeker highlighted Phase III setmelanotide data in acquired HO (BMI -19.8% vs placebo) and Phase II bivamelagon results (BMI -9.7% at 12 weeks), positioning for 2026 Phase III trials.
- $189M equity raise in July 2025, providing >24-month cash runway, with $291M cash on hand.
- HO prevalence estimates at 5,000-10,000 in U.S., with 10,000+ globally, targeting 2026 EMANATE trial readout.

**【CFO Financial Commentary】**
- Q2 2025 GAAP net loss $0.75/sh, non-GAAP R&D/Sales & Marketing expenses $42.3M/$45.9M, up 14%/18% QoQ due to clinical trial expansion and commercial headcount growth.
- U.S. revenue +31% QoQ to $31.5M, international +24% to $11.5M (EUR/GBP appreciation +$1.2M), with 12% patient growth.
- Cost of sales 11.4% of revenue, stable vs prior quarters.
- 2025 non-GAAP OpEx guidance $285-315M (R&D $150-170M, SG&A $135-145M).

**【Q&A Highlights】**
- Prader-Willi Phase II open-label trial (n=10-20) targeting 6-month data, with 5mg dose escalation; CEO cautious on 50-50 success odds due to disease complexity.
- Japan team building for 2026 regulatory filings; named patient sales in Poland, Czech Republic.
- HO off-label use minimal in U.S., but 10%+ of international patients already on therapy via early access programs.
- 718 Phase II targeting Q1 2026 enrollment, with weekly dosing and 6-month data readout.
- Stock comp $15.9M Q2, driven by $85/sh equity raise, complicating OpEx forecasting.

Rhythm Pharmaceuticals (RYTM)-5 Aug 25-2025 Q2 Earnings call transcript

- **HO Phase 3 success**: 16.5% BMI reduction vs. placebo, with consistent pediatric response (ages 4-18). FDA filing on track for Q3 2025.
- **Commercial resilience**: $37.7M Q1 revenue despite $8.3M inventory swing, driven by 14% global patient growth and ex-US expansion.
- **Key strategic moves**: Reacquired China rights, preparing for 2027 cash runway, and targeting >10% BMI reduction in bivamelagon Phase 2.

**【CEO Summary Section】**
- Phase 3 trial results for acquired hypothalamic obesity (HO) showed a 16.5% BMI reduction in setmelanotide-treated patients vs. a 3.3% increase in placebo, with consistent responses across age groups (including children as young as 4). FDA Type D meeting scheduled for Q3 2025 filing.
- US commercial demand for IMCIVREE (Bardet-Biedl syndrome) grew despite a $8.3 million inventory swing at the specialty pharmacy, with sequential patient growth of 14% globally.
- International expansion in France and Italy drove HO revenue, with 24 patients in the French real-world experience showing significant weight loss.

**【CFO Financial Commentary】**
- Q1 2025 revenue: $37.7 million (IMCIVREE), up 45% YoY, with US revenue impacted by inventory swings but ex-US growth of $3.1 million.
- Net loss: $0.81 per share (GAAP), driven by $6.3 million China rights reacquisition and $40.4 million cash used in operations.
- Cash runway: $314.5 million, sufficient for operations into 2027.

**【Commercial Highlights】**
- US prescriber growth: 13% QoQ, with 1/3 of new prescribers becoming repeat prescribers.
- Medicaid access expanded to cover >95% of Medicaid lives, reducing Bridge program usage to pre-Q1 levels.
- HO patient persistence: <10% discontinuation rate in Phase 3, with high compliance despite complex medical needs.

**【Q&A Highlights】**
- **Non-responders**: 3/8 dropouts had pre-existing conditions (e.g., seizures), while 3/9 completers had alternative measures of response (Z-score reduction).
- **Bivamelagon Phase 2**: Expected Q3 readout; targeting >10% BMI reduction threshold, with focus on safety and tolerability.
- **HO launch prep**: Endocrinologist engagement >50%, with similar prescribing patterns to BBS but faster uptake due to diagnosed patient pool.
- **China strategy**: Reacquired rights; evaluating go-it-alone vs. partner approach for Asia-Pacific expansion.

Rhythm Pharmaceuticals, Inc. (RYTM) Q1 2025 Earnings Call Transcript

- **Financial Strength**: $320.6M cash on hand, supporting 2025-2027 pipeline execution.
- **Revenue Growth**: Q4 2024 net revenue up 72% YoY, driven by BBS and international expansion.
- **HO Trial Momentum**: Q2 2025 Phase 3 readout targeting 50/50 pediatric-adult split, with Japan 2026 data.
- **Next-Gen Pipeline**: Bivamelagon and RM-718 trials progressing, with H2 2025 data readouts.
- **Strategic Expansion**: Turkey partnership and Japan focus capitalize on high HO prevalence.

**【CEO Summary Section】**
- Entered 2025 with $320.6M cash, extended runway to 2027 through ATM program.
- Completed enrollment in Phase 2 daily oral bivamelagon study for acquired HO.
- BBS market opportunity expected to grow steadily, with U.S. sales at $41.8M in Q4 2024.
- Next-gen compounds (bivamelagon, RM-718) designed for improved convenience and MC4R specificity, with Phase 2 data expected H2 2025.

**【CFO Financial Commentary】**
- Q4 2024 net revenue $41.8M, +72% YoY; full year $138.1M, +85% YoY.
- R&D expenses $41.2M (Q4), driven by bivamelagon and RM-718 trials.
- SG&A expenses $38.1M (Q4), up 8% QoQ due to headcount and marketing.
- 2025 non-GAAP OpEx guidance: $285M-$315M, reflecting HO launch preparation.

**【Q&A Key Highlights】**
- HO Phase 3 trial expected Q2 2025 readout, targeting 50/50 pediatric/adult split.
- Japan has higher HO prevalence, with potential 2026 data from 12-patient cohort.
- Pediatric label expansion for BBS (2+ years) shows strong adherence, but minimal near-term revenue impact.
- Strategic partnership in Turkey to leverage local rare disease expertise.
- RM-718 Phase 1 Part C enrollment begins Q1 2025, with data expected late 2025.
- Bivamelagon Phase 2 HO data expected H2 2025, with focus on MC4R agonism vs. setmelanotide.


Rhythm Pharmaceuticals, Inc. (RYTM) Q4 2024 Earnings Call Transcript

Rhythm Pharmaceuticals (RYTM)-5 Nov 24-2024 Q3 Earnings call transcript

Rhythm Pharmaceuticals (RYTM)-6 Aug 24-2024 Q2 Earnings call transcript

Rhythm Pharmaceuticals (RYTM)-7 May 24-2024 Q1 Earnings call transcript

- **Revenue Growth**: Q4 2023 revenue $24.2M (175% YoY), driven by international expansion.
- **Japan Market Potential**: 5,000-8,000 patients with streamlined regulatory path, targeting 2025 filings.
- **New Drug Pipeline**: Weekly RM17 and oral LB-54640 expected to dose patients in 2024, addressing hyperpigmentation concerns.
- **Pediatric Expansion**: EU label for 2-5-year-olds with 18% weight loss data, U.S. filing Q3 2024.
- **Operational Risks**: 20% discontinuation rate, 30 patients on bridge program, and $100M upfront costs for LB-54640.

**【CEO Summary Section】**
- **Transformational Year**: 2023 marked significant progress in commercial, developmental, and strategic growth, with 2024 focused on execution and 2025 milestone achievements.
- **Japan Regulatory Breakthrough**: Secured PMDA agreement to include 12 Japanese patients in the Phase III trial, avoiding separate PK studies. Japan's higher prevalence (5,000-8,000 patients) positions it as a key market.
- **New Drug Acquisitions**: Acquired LB-54640 (daily oral MC4R agonist) from LG Chem, with $100M upfront costs. Weekly injectable RM17 expected to dose first patients in March 2024.
- **Pediatric Expansion**: Filed for EU label expansion to children aged 2-5, with U.S. filing planned for Q3 2024. Data shows 18% weight loss at 1 year in pediatric patients.

**【CFO Financial Commentary】**
- **Q4 2023 Revenue**: $24.2M (175% YoY growth), driven by international expansion. U.S. revenue flat due to 30 patients transitioning to a bridge program.
- **Operating Expenses**: Non-GAAP OpEx $250-270M for 2024, including $10-15M for LB-54640 development. Cash reserves $276M, sufficient for 2025 activities.
- **Cost Structure**: Gross to net 85%, with Medicaid rebate adjustments. R&D and SG&A growth expected at 15-18% YoY.

**【Q&A Highlights】**
- **U.S. Medicaid Cluster**: Unique state policy requiring ophthalmology confirmation led to $2M revenue loss. 30 patients remain on bridge therapy, with reauthorization rates >90%.
- **Japan Pricing Strategy**: Expected to align with Europe, using U.S. and European references. PK consistency with Western trials.
- **Next-Gen Drugs**: Weekly RM17 and oral LB-54640 aim to reduce hyperpigmentation and improve compliance. SIGNAL trial efficacy vs. setmelanotide.
- **Commercial Dynamics**: 20% discontinuation rate, driven by side effects and adherence. Spain and Italy launches in 2025.

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