Madrigal Pharmaceuticals has announced its third-quarter 2024 financial results, highlighting a successful U.S. launch of Rezdiffra (resmetirom) and providing key corporate updates. The company's focus remains on developing and delivering novel therapeutics for nonalcoholic steatohepatitis (NASH), also known as metabolic dysfunction-associated steatohepatitis (MASH). With the U.S. launch progressing well and European expansion on the horizon, Madrigal is poised to address the critical need for effective treatments for this growing liver disease.
Financial Performance
For the third quarter of 2024, Madrigal Pharmaceuticals reported net revenues of $62.2 million, a significant increase compared to the same period last year, where no product sales were recognized. The company experienced a net loss of $106.9 million, or $4.92 per share, compared to a net loss of $98.7 million, or $5.34 per share, in the prior year period. Operating expenses increased to $178.5 million from $98.5 million in the prior year period, primarily due to increased selling, general, and administrative expenses related to the commercial launch of Rezdiffra.
Rezdiffra Launch and Clinical Progress
The U.S. launch of Rezdiffra (resmetirom) has demonstrated strong initial performance, achieving over 80% commercial coverage ahead of schedule. This progress is attributed to growing adoption by prescribers, broader payer coverage, and an increasing number of patients initiating therapy. Madrigal has also completed enrollment in its MAESTRO-NASH OUTCOMES trial, a crucial step towards securing full approval and a broader indication for Rezdiffra. Positive health-related quality of life data from the Phase 3 MAESTRO-NASH trial has been published in the journal Hepatology, further supporting the clinical benefits of Rezdiffra.
Strategic Initiatives and Future Outlook
Madrigal is actively pursuing strategic initiatives to expand the reach and impact of Rezdiffra. In October, Dr. Michael Charlton was appointed as Senior Vice President of Clinical Development, strengthening the company's leadership team. Madrigal is also preparing for a significant presence at the upcoming AASLD Liver Meeting, with more than ten abstracts accepted for presentation. Furthermore, the company is focused on European expansion, with Rezdiffra currently under evaluation by the European Medicines Agency (EMA). A decision on the Marketing Authorization Application (MAA) for Rezdiffra is expected by mid-year 2025, and Madrigal plans to directly commercialize resmetirom in Europe if the decision is positive. According to Bill Sibold, Chief Executive Officer of Madrigal, the company recognizes 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.
Positive results from the MAESTRO-NASH OUTCOMES trial could significantly expand Rezdiffra's eligible patient population and support full approval in noncirrhotic NASH, solidifying its position as a key therapeutic option for patients with NASH/MASH.
