Madrigal Pharmaceuticals (MDGL) Q4 2025 earnings summary

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.