MDGL — Madrigal Pharmaceuticals, Inc.

Summary of Madrigal Pharmaceuticals Q4 2025 Earnings Call

1. Key Financial Results and Metrics

• Q4 2025 Net Sales: $321.1 million, more than tripling from Q4 2024.
• Full Year 2025 Net Sales: $958.4 million, marking a successful launch of Rezdiffra.
• Gross-to-Net Impact: Increased from Q3 to Q4 2025; full-year average at the low end of the previously outlined 20%-30% range.
• Cash Position: Ended Q4 2025 with $988.6 million in cash and equivalents, providing ample resources for ongoing operations and pipeline development.

2. Strategic Updates and Business Highlights

• Rezdiffra Launch: Positioned as the foundational therapy in the MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease) market, which has grown nearly 50% since the end of 2023.
• Patient Growth: Ended Q4 with over 36,250 patients on Rezdiffra, up from 29,500 in Q3.
• Pipeline Development: Expanded to over 10 programs, including an oral GLP-1, a late-stage DGAT-2 inhibitor, and a portfolio of preclinical siRNA targets.
• International Expansion: Initiated the rollout of Rezdiffra in Germany, although contributions are expected to be negligible in 2026.

3. Forward Guidance and Outlook

• 2026 Expectations: Anticipate robust net sales growth despite a projected increase in gross-to-net impact to the high 30% range due to new payer agreements.
• Market Growth: Expect double-digit growth in the MASH market for the foreseeable future, with potential expansion into the F4c population, which could double the commercial opportunity for Rezdiffra.
• R&D Strategy: Focus on delivering outcomes data for F4c and advancing combination therapies anchored by Rezdiffra.

4. Bad News, Challenges, or Points of Concern

• Competitive Pressures: The presence of GLP-1 therapies in the market, such as Wegovy, could pose challenges, although Rezdiffra has shown resilience in patient additions.
• Reimbursement Challenges: Potential issues with keeping patients on Rezdiffra long-term due to reimbursement processes, especially if patients improve and fall outside label requirements.
• International Market Uncertainty: The rollout in Germany and other ex-U.S. markets remains uncertain, with negligible contributions expected in 2026.

5. Notable Q&A Insights

• Patient Growth Drivers: Increased awareness and diagnosis of MASH, aided by competitor marketing efforts, are driving patient growth.
• Persistence Rates: Current persistence rates for Rezdiffra are in the 60%-70% range, with some institutions reporting up to 90%. Efforts are underway to improve these rates.
• Combination Therapy Strategy: The company is cautious about adding too many combination therapies, focusing on those with strong mechanistic rationale and adaptability based on ongoing clinical data.
• AI in Drug Development: The FDA's interest in AI-supported pathology reads may influence future studies, although current trials are primarily event-driven rather than histology-driven.

Overall, Madrigal Pharmaceuticals is positioned for strong growth in the MASH market with Rezdiffra, backed by a solid financial foundation and an expanding pipeline, despite facing competitive pressures and uncertainties in international markets.