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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

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MDGL

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