Madrigal Pharmaceuticals, Inc. Q2 FY2025 earnings call

• New U.S. patent for Rezdiffra issued, extending protection to February 2045, based on clinical data from MAESTRO-NASH.
• Rezdiffra's U.S. performance: over 23,000 patients on therapy, 80% of top 6,000 targets prescribing, annualizing to over $800M.
• International expansion: Preparing to launch Rezdiffra in Germany later this year, with positive CHMP opinion for EU approval.
• Expansion of Rezdiffra indication: Ongoing OUTCOMES trial for compensated MASH cirrhosis (F4c) with high unmet need.
• Pipeline development: In-licensed oral GLP-1 from CSPC Pharma for combination with Rezdiffra, expected to close in Q4 2025 and enter clinic in H1 2026.

In the second quarter of 2025, Madrigal Pharmaceuticals reported net sales of $212.8 million, a 55% increase from the previous quarter. Rezdiffra's quarterly run rate exceeds $200 million, with an annualized run rate well over $800 million. Rezdiffra contributes significantly to the revenue, with the U.S. market being the key driver, having more than 23,000 patients on therapy and 80% of the top 6,000 targets prescribing.

• Rezdiffra's quarterly run rate exceeding $200M, on track for blockbuster status.
• Anticipated EU launch in Germany later this year, with EU approval expected.
• Continued growth with Rezdiffra, including expansion into F4c indication and combination therapy.
• Non-dilutive financing from Blue Owl Capital to fund oral GLP-1 license and future strategic activities.

• Potential competition from injectable GLP-1s, though Rezdiffra's profile is favorable.
• Uncertainty around payer dynamics and step edits related to GLP-1s.
• Dependence on successful outcomes of the OUTCOMES trial for F4c indication.

Q: Expand on gross to net and inventory dynamics in the quarter?

A: Mardi Dier stated gross to net is choppy early in launch but within expected range, with minimal impact from contracting in Q2 and more impact expected in H2. Bill Sibold emphasized long-term view on gross to net.

Q: How does the entrance of GLP-1s affect growth curve?

A: William Sibold said steady growth expected, familiarity with GLP-1s, and planned scenarios for all eventualities, with combination use already established.

Q: EU approval timeline and revenue recognition?

A: William Sibold mentioned EU approval expected later this month, with launch in Germany in H2 2025, and revenue recognition primarily in 2026 and beyond