Madrigal Pharmaceuticals Reports Fourth-Quarter and Full-Year 2024 Financial Results and Announces New Two-Year Data Demonstrating Potential Benefit of Rezdiffra™ (resmetirom) in Patients with Compensated MASH Cirrhosis

Core Insights - Madrigal Pharmaceuticals achieved FDA approval for Rezdiffra, the first treatment for metabolic dysfunction-associated steatohepatitis (MASH), in March 2024, and successfully launched it in the U.S. market [2][4] - The company reported significant financial results for Q4 and full-year 2024, with net sales of $103.3 million and$180.1 million respectively, and a patient base exceeding 11,800 on Rezdiffra by year-end [5][7] - New two-year data from the Phase 3 MAESTRO-NAFLD-1 trial indicates Rezdiffra significantly reduces liver stiffness in patients with compensated MASH cirrhosis, supporting its potential as a leading therapy in this high-risk population [6][8] Financial Performance - Fourth-quarter 2024 net revenues were $103.3 million, with full-year revenues reaching$180.1 million, marking a significant increase from the previous year when no product sales were recorded [7][26] - Operating expenses for Q4 and full-year 2024 were $170.3 million and$678.0 million respectively, compared to $117.2 million and$380.5 million in the prior year, reflecting increased costs associated with the commercial launch of Rezdiffra [7][26] - The company reported a net loss of $59.4 million for Q4 2024 and$465.9 million for the full year, with basic and diluted net loss per share of $2.71 and$21.90 respectively [26] Clinical Developments - The MAESTRO-NAFLD-1 trial demonstrated a mean reduction of 6.7 kPa in liver stiffness among patients treated with Rezdiffra, the largest reduction reported in this patient population to date [6] - 51% of patients in the trial achieved a ≥ 25% reduction in liver stiffness, which is associated with a decreased risk of progression to end-stage liver disease [6] - The ongoing MAESTRO-NASH OUTCOMES trial, which is fully enrolled, could position Rezdiffra as the only treatment for F2 to F4c MASH, with results expected in 2027 [6][8] Market Position and Future Growth - Rezdiffra is recommended as a first-line therapy for MASH by expert guidelines and has been recognized in updated practice guidelines from leading liver disease organizations [8] - The company plans to expand into the European market, with a launch expected in Germany in the second half of 2025, pending EMA approval [8] - Madrigal is focused on reaching approximately 315,000 patients with moderate to advanced fibrosis in the U.S., with expectations of increasing disease awareness and prevalence [13][19]