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- **Revenue Surge**: Q3 2025 sales $287M (+35% QoQ), annualizing >$1B with 29,500+ patients on therapy.
- **Payer Triumph**: 2026 contracts secure first-line access, gross-to-net to rise to high 30% in 2026.
- **Pipeline Power**: Phase 3 F4C trial on track for 2027 readout, GLP-1 combo MGL-2086 Phase 1 starts H1 2026.
- **Global Growth**: Germany launch underway, targeting 315,000 diagnosed F2-F3 patients with 90%+ untreated market share.

**【CEO Summary Section】**
- **Revenue Growth**: Q3 2025 net sales of $287 million, up 35% QoQ, annualizing over $1 billion in its sixth quarter of launch.
- **Patient and Prescriber Metrics**: 29,500+ patients on therapy (up 28% QoQ), 10,000+ prescribers, targeting 315,000 diagnosed F2-F3 patients.
- **Payer Progress**: 2026 contracts for first-line access with no step edits, gross-to-net expected at 20-30% in Q4 2025, rising to high 30% in 2026.
- **Pipeline Momentum**: Phase 3 Maestro NASH outcomes trial in F4C cirrhosis (readout 2027), GLP-1 combo MGL-2086 Phase 1 starting H1 2026, and global expansion (Germany launch Q3 2025).

**【CFO Financial Commentary】**
- **Financial Performance**: Q3 2025 net sales $287.3M, R&D expenses $174M (includes $117M one-time GLP-1 license), SG&A $209.1M (commercial scale-up).
- **Gross Margin Management**: Q3 2025 gross-to-net ~15%, Q4 2025 midpoint 20-30%, 2026 high 30%+ aligned with specialty peers.
- **Balance Sheet Strength**: $1.1B cash, $350M term loan supporting launch and pipeline.

**【Q&A Key Highlights】**
- **Adherence & Real-World Data**: 80%+ adherence vs. 40-60% for GLP-1s, AASLD data shows sustained efficacy in F4C cirrhosis.
- **Competitive Positioning**: Leading first-mover advantage with Rezdiffra's liver-directed profile, GLP-1s show 70% discontinuation rates.
- **European Strategy**: Germany launch Q3 2025, disciplined country-by-country expansion targeting 2-3 year ROI.
- **Pipeline Strategy**: GLP-1 combo targeting 5% weight loss to enhance Rezdiffra efficacy, exploring complementary mechanisms beyond 2026.

Madrigal Pharmaceuticals, Inc. (MDGL) Q3 2025 Earnings Call Transcript

- **Revenue Surge**: Q2 2025 sales of $213M (+55% QoQ), annualizing at $800M+ with 23,000+ patients on therapy.
- **Patent Milestone**: U.S. patent extended to 2045, protecting Rezdiffra's dosing regimen and enabling decades of growth.
- **GLP-1 Partnership**: $120M upfront for oral GLP-1 (SYH2086), targeting combination therapy for enhanced NASH efficacy.
- **F4C Potential**: 2-year data shows liver stiffness reduction and CSPH improvement, with 245,000 U.S. F4C patients as new addressable market.
- **Financial Strength**: $802M cash, 20-30% gross to net range, and $350M credit facility for strategic growth.

**【CEO Summary Section】**
- **Revenue Growth**: Q2 2025 net sales of $213 million, up 55% QoQ, annualizing at over $800 million. U.S. Rezdiffra net sales exceed $200 million quarterly run rate.
- **Patient and Prescriber Metrics**: 23,000+ patients on therapy (up 35% QoQ), 80% of top 6,000 prescribers have prescribed Rezdiffra, and 60% of broader 14,000 targets have written prescriptions.
- **Patent Extension**: New U.S. patent extends protection to February 2045, based on dosing regimen tied to FDA label, providing decades of revenue potential.
- **Pipeline Expansion**: In-licensed oral GLP-1 (SYH2086) for combination therapy, with $120M upfront payment and potential future milestones. First-in-class for NASH cirrhosis with 2-year data showing liver stiffness reduction and CSPH improvement.
- **International Expansion**: EU CHMP positive opinion for Rezdiffra, targeting Germany launch in H2 2025. European diagnosed F2-F3 population ~370,000.

**【CFO Financial Commentary】**
- **Q2 2025 Financials**: Net sales $212.8M, R&D expenses $54.1M (down 24% YoY), SG&A $196.9M (up 87% YoY due to commercial launch). Cash balance $802M, with $350M term loan from Blue Owl for GLP-1 licensing.
- **Gross to Net**: Expected 20-30% range for 2025, with minimal Q2 impact from contracting. QoQ choppy due to launch dynamics, but stable visibility for remainder of year.
- **Operating Expenses**: Q3/Q4 2025 SG&A modestly higher than Q2, driven by U.S. and EU launch activities.

**【Q&A Highlights】**
- **GLP-1 Competition**: Rezdiffra's liver-directed mechanism and real-world adherence (~50% patients on GLP-1) position it as foundational therapy. Semaglutide's 30% 1-year adherence and limited efficacy in diabetic patients contrast with Rezdiffra's consistent results.
- **Gross to Net Dynamics**: 20-30% range maintained, with contracting impact expected to increase in H2 2025. No plans for aggressive rebates to match semaglutide pricing.
- **International Launch**: Germany launch in H2 2025, with EU approval expected in August. European guidelines already recommend Rezdiffra as first-line for NASH.
- **F4C Expansion**: 2-year open-label data shows 6.7 kPa liver stiffness reduction and 35% F4-to-F3 regression. MAESTRO-NASH outcomes trial expected to report in 2027, targeting 245,000 U.S. F4C patients.
- **Business Development**: Open to additional BD opportunities, prioritizing assets that complement Rezdiffra's liver-directed mechanism. Fixed-dose combo with SYH2086 possible but not required.

Madrigal Pharmaceuticals (MDGL)-5 Aug 25-2025 Q2 Earnings call transcript

- **Revenue Momentum**: Q1 2025 sales up 33% QoQ, with 12-month cumulative sales of $317M.
- **Market Leadership**: 70% of top prescribers adopting Rezdiffra, targeting 315,000 F2-F3 patients (5% penetration).
- **Pipeline Expansion**: Phase 3 F4c trial underway; EU launch planned for H2 2025.
- **Financial Strength**: $848M cash; GTN discounts managed within expectations.
- **Competitive Edge**: Rezdiffra's liver-directed profile outperforms GLP-1s in real-world adherence and efficacy.

**【CEO Launch Update】**
- **Revenue Growth**: Q1 2025 net sales of $137M, up 33% QoQ, with 12-month cumulative sales of $317M.
- **Patient Adoption**: 17,000+ active patients (80% of diagnosed F2-F3 MASH population), with 5% penetration of 315,000 target patients.
- **Physician Penetration**: 70% of top 6,000 targets prescribing Rezdiffra, up from 40% a year ago.
- **Strategic Expansion**: Phase 3 MAESTRO-NASH OUTCOMES trial in F4c cirrhosis (845 patients) expected to report in 2027; EU regulatory decision mid-2025, with Germany launch planned for H2 2025.
- **Pipeline Development**: Actively evaluating complementary assets for MASH pipeline, with CMO Dave Soergel leading R&D efforts.

**【CFO Financial Highlights】**
- **Gross-to-Net Management**: Q1 GTN discounts in line with expectations, with step-up in 2025 due to payer contracting.
- **R&D Expenses**: $44.2M (down 38% YoY) due to FDA approval-related inventory costs.
- **SG&A Expenses**: $167.9M (up 108% YoY) driven by US launch and European preparation.
- **Cash Position**: $848M in cash, supporting US expansion and European launch.

**【Q&A Key Takeaways】**
- **Competitive Landscape**: 25% of Rezdiffra patients on GLP-1s, but no step-through risk; Rezdiffra's liver-directed mechanism positions it as foundational therapy.
- **Payer Dynamics**: 80% payer coverage; reauthorization policies stable, with 12-month review aligned with clinical trial timelines.
- **Europe Strategy**: EMA decision mid-2025; pricing expected to reflect innovation value, with 50% of F2-F3 patients already exposed to GLP-1s.
- **F4c Data**: Two-year F4c data shows 6.7 kPa liver stiffness reduction, with 51% achieving ≥25% improvement, aligning with JAMA-defined reversal of cirrhosis thresholds.

Madrigal Pharmaceuticals, Inc. (MDGL) Q1 2025 Earnings Call Transcript

- **Q4 2024 sales beat expectations**: $103.3M (66% QoQ growth), 9-month $180.1M total. 
- **F4c data breakthrough**: 6.7 kPa liver stiffness reduction, 25% of patients achieving clinically meaningful improvement. 
- **Europe launch confidence**: Germany-focused approach with 2027 OUTCOMES trial readout. 
- **Competitive resilience**: GLP-1s seen as complementary, Rezdiffra's 91% liver fibrosis improvement unmatched. 
- **Financial strength**: $931M cash, 2025 net sales growth driven by 90%+ F2/F3 addressable market penetration.

**【CEO Overview】**
- Q4 2024 net sales: $103.3M (66% QoQ growth), full year 2024: $180.1M (9-month launch). 
- 11,800+ patients on therapy, <4% penetration of 315K diagnosed F2/F3 MASH patients. 
- 60% of top 6,000 prescribers wrote Rezdiffra in Q4, up from 40% in Q3. 
- 2-year F4c data: 6.7 kPa liver stiffness reduction (25% of patients achieved ≥25% improvement). 
- Europe launch expected mid-2025, starting with Germany. 
- MAESTRO-NASH OUTCOMES trial (845 F4c patients) to report in 2027. 

**【CFO Financial Update】**
- 2024 net sales: $180.1M (9-month). 
- R&D expenses: $236.7M (down 35% YoY due to reduced clinical trial costs). 
- SG&A expenses: $435.1M (up 302% YoY for U.S. commercial scale). 
- Cash balance: $931.3M (strong for U.S. and Europe launches). 
- 2025 outlook: higher gross-to-net discounts (~10-12% vs 2024's 7-8%), but confident in robust YoY growth. 

**【Q&A Highlights】**
- **Q1 2025 momentum**: Teams managing Q1 dynamics well, no prescriber saturation. 
- **Competitor impact**: GLP-1s (e.g., semaglutide) seen as market expanders, not direct threats. 25% of Rezdiffra patients already on GLP-1s. 
- **Europe strategy**: Country-by-country launches with focus on value demonstration. 
- **Part D redesign**: ~3-5% net sales impact, included in 2025 guidance. 
- **Safety profile**: F4c data shows Rezdiffra safety consistent with earlier trials, no new risks identified. 
- **Pipeline expansion**: Actively evaluating assets to build post-Rezdiffra portfolio.

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