Madrigal Pharmaceuticals announced its third-quarter 2024 financial results, highlighting a successful U.S. launch of Rezdiffra™ (resmetirom) and continued clinical development in nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH). The company reported net sales of $62.2 million for Rezdiffra in the third quarter, driven by growing adoption among prescribers and broader payer coverage.
Rezdiffra Launch and Market Access
According to Madrigal, Rezdiffra has achieved coverage for over 80% of commercial lives in the U.S., surpassing initial coverage goals ahead of schedule. Notably, less than 5% of covered lives require biopsy for diagnosis, aligning with current standards of care that favor non-invasive tests (NITs). Bill Sibold, CEO of Madrigal, noted that the early success of Rezdiffra underscores the urgent need for effective treatments for moderate to advanced NASH/MASH, which is projected to become the leading cause of liver transplants in the U.S.
Clinical Development and Expansion
Madrigal has completed enrollment in the MAESTRO-NASH OUTCOMES trial, which evaluates Rezdiffra in patients with compensated NASH cirrhosis. Positive results from this study could lead to full approval and a broader indication for Rezdiffra, potentially making it the first approved medicine for patients with compensated cirrhosis. The company also highlighted the appointment of Dr. Michael Charlton as Senior Vice President of Clinical Development, bringing over 30 years of experience in hepatology and liver transplantation to the team.
Quality of Life Data
In September, data from the Phase 3 MAESTRO-NASH trial, published in the Journal of Hepatology, demonstrated that patients treated with Rezdiffra experienced clinically meaningful and statistically significant improvements in emotional well-being and health distress.
European Expansion
Rezdiffra is under evaluation by the European Medicines Agency (EMA), with a decision on the Marketing Authorization Application (MAA) expected by mid-2025. Madrigal plans to directly commercialize resmetirom in Europe, pending a positive decision from the EMA.
Financial Highlights
Total revenues for the third quarter of 2024 were $62.2 million, compared to no product sales in the prior year period. Operating expenses totaled $178.5 million, including $68.7 million in R&D expense and $107.6 million in SG&A expense. As of September 30, 2024, Madrigal reported cash, cash equivalents, restricted cash, and marketable securities of $1.0 billion.
