Madrigal Pharmaceuticals (MDGL) Q1 2025 earnings summary

Executive summary

• Achieved $137.3 million in Q1 2025 net sales for Rezdiffra, the first FDA-approved MASH therapy, with over 17,000 patients on therapy and strong prescriber adoption.

• Rezdiffra's launch transformed the company into a fully integrated commercial-stage organization, with broad payer coverage and rapid prescriber uptake.

• Two-year F4c data from MAESTRO-NAFLD-1 trial showed significant reduction in liver stiffness and a strong safety profile, with additional data to be presented at EASL Congress.

• Leadership changes included David Soergel, M.D. as Chief Medical Officer, Rebecca Taub, M.D. as Senior Scientific and Medical Advisor, and Jacqualyn Fouse, Ph.D. joining the Board.

• Expansion efforts underway for F4c indication and international markets, with a potential EMA decision mid-2025 and a planned Germany launch in H2 2025.

Financial highlights

• Q1 2025 net sales/revenue reached $137.3 million, a 33% increase quarter-over-quarter, with no product sales in the prior year period.

• SG&A expenses rose to $167.9 million in Q1 2025, up 108% year-over-year, driven by commercial launch investments and increased headcount.

• R&D expenses decreased to $44.2 million in Q1 2025, down from $71.2 million year-over-year, due to inventory accounting changes and lower clinical trial costs.

• Net loss narrowed to $73.2 million in Q1 2025 from $147.5 million in Q1 2024.

• Cash, cash equivalents, restricted cash, and marketable securities totaled $848.1 million at March 31, 2025.

Outlook and guidance

• Expect robust year-over-year net sales growth in 2025, with gross-to-net discounts increasing as payer contracting expands.

• SG&A expenses anticipated to rise further in 2025, especially with European launch preparations.

• European regulatory decision for Rezdiffra anticipated mid-2025, with a planned launch in Germany in H2 2025.

• Management expects continued losses until Rezdiffra and other products generate sufficient revenue.

• Confident in continued patient and prescriber growth, with only 5% market penetration among target MASH patients.