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Madrigal Pharmaceuticals (MDGL) investor relations material
Madrigal Pharmaceuticals Q4 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Executive summary
Achieved $958.4M in net sales for Rezdiffra in FY25, with $321.1M in Q4 and over 36,250 patients treated by year-end, establishing it as the foundational MASH therapy and driving rapid market expansion.
Achieved landmark FDA approval for Rezdiffra in March 2024 and launched in Germany after EC approval, making it the first and only approved MASH therapy in the US and EU.
Expanded pipeline to over 10 programs, including oral GLP-1, DGAT-2 inhibitor, and siRNA assets, with IND-enabling and clinical studies planned for 2026-2027.
Extended Rezdiffra's patent exclusivity to 2045 and secured Orange Book-listed protection.
Positioned for long-term leadership in a specialty market expected to exceed $20B annually, with significant growth potential as F2/F3 MASH penetration remains below 12%.
Financial highlights
Q4 2025 net sales reached $321.1M, up from $103.3M in Q4 2024; full-year 2025 net sales totaled $958.4M, up from $180.1M in 2024.
Operating expenses for Q4 and full-year 2025 were $380.7M and $1,258.5M, with R&D at $388.5M and SG&A at $813.8M, both increasing to support launch and pipeline expansion.
Net loss for Q4 was $58.6M and for the year $288.3M, with basic and diluted net loss per share for 2025 at $12.85.
Ended Q4 2025 with $988.6M in cash, cash equivalents, restricted cash, and marketable securities.
Gross to net impact averaged at the low end of the 20%-30% range for 2025; expected to rise to the high 30% range in 2026 due to new payer contracts.
Outlook and guidance
Robust net sales growth expected in 2026, driven by broader first-line access, increased disease awareness, and positive real-world experience, despite higher gross to net and typical Q1 insurance dynamics.
Ex-US contribution, including Germany, expected to remain negligible in 2026; US remains the core business.
R&D expenses projected to remain flat in 2026; SG&A to increase as launch and pipeline investments continue.
Indication expansion into F4c (compensated MASH cirrhosis) could double the addressable market, with outcomes data anticipated in 2027.
Plans to initiate IND-enabling activities for siRNA candidates and begin clinical trials for oral GLP-1 (MGL-2086) in 2026.
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