Madrigal Pharmaceuticals announced its third-quarter 2024 financial results and provided updates on its corporate activities, highlighting the successful U.S. launch of Rezdiffra™ (resmetirom) and the advancement of its clinical programs in nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH). The company's progress underscores the urgent need for effective treatments for NASH/MASH, which is projected to become the leading cause of liver transplants in the U.S.
Rezdiffra Launch and Market Access
The U.S. launch of Rezdiffra is progressing well, driven by strong execution and growing adoption among prescribers. As of September 30, 2024, coverage for Rezdiffra was secured for over 80% of commercial lives in the U.S., surpassing the company's initial target. Notably, less than 5% of covered lives require a biopsy for diagnosis, aligning with current non-invasive testing (NIT) standards of care.
Bill Sibold, Chief Executive Officer of Madrigal, stated, "Our U.S. launch of Rezdiffra is progressing exceptionally well driven by the outstanding execution of our team. Growing adoption by prescribers, broader payer coverage and an increasing number of patients on therapy each contributed to the strong performance."
Clinical Development Milestones
Madrigal has completed enrollment in the MAESTRO-NASH OUTCOMES trial, which is evaluating 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.
Sibold continued, "We've also advanced our pipeline, completing enrollment in our clinical outcomes study for patients with compensated NASH/MASH cirrhosis. This milestone is key, as positive results could lead to full approval and a broader indication for Rezdiffra."
Financial Highlights
For the third quarter of 2024, Madrigal reported net revenues of $62.2 million, compared to no product sales in the same period last year. Operating expenses totaled $178.5 million, including $68.7 million in R&D expenses and $107.6 million in SG&A expenses. The company's cash, cash equivalents, restricted cash, and marketable securities stood at $1.0 billion as of September 30, 2024.
European Expansion
Rezdiffra is currently under evaluation by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). A decision from the EMA on the Marketing Authorization Application (MAA) is expected mid-year 2025. Madrigal plans to commercialize resmetirom directly in Europe, pending a positive decision from the EMA.
About NASH/MASH
NASH, now also known as MASH, is a progressive form of nonalcoholic fatty liver disease (NAFLD) characterized by liver inflammation and damage. It is a leading cause of liver-related mortality and a growing burden on healthcare systems. Madrigal estimates that approximately 1.5 million patients have been diagnosed with NASH in the U.S., with approximately 525,000 having moderate to advanced liver fibrosis.
