Madrigal Pharmaceuticals Announces Preliminary* Fourth-Quarter and Full-Year 2024 Net Sales, Year-End Cash and Total Patients on Rezdiffra

Business Performance and Financial Updates - Preliminary fourth-quarter 2024 Rezdiffra net sales range between $100 million to $103 million, and full-year 2024 net sales range between $177 million to $180 million [4][5] - Preliminary year-end 2024 cash, cash equivalents, restricted cash, and marketable securities total approximately $931 million [4][5] - Over 11,800 patients were on Rezdiffra therapy as of year-end 2024 [4][5][13] Key Milestones and Achievements - Rezdiffra received U.S. FDA approval on March 14, 2024, becoming the first and only approved therapy for MASH [5] - The Phase 3 MAESTRO-NASH trial results were published in The New England Journal of Medicine and recognized as one of the 14 notable scientific research articles of 2024 [5] - EMA validated the Marketing Authorization Application (MAA) for Rezdiffra on March 5, 2024, with an anticipated decision in mid-2025 and a potential European launch starting in Germany in the second half of 2025 [5] - Enrollment for the MAESTRO-NASH OUTCOMES study, evaluating Rezdiffra in patients with compensated MASH cirrhosis, was completed on October 21, 2024 [5] Market Opportunity and Disease Overview - MASH is a serious liver disease that can progress to cirrhosis, liver failure, liver cancer, and premature mortality, and is expected to become the leading cause of liver transplantation in the U.S. [3][6] - Patients with moderate to advanced liver fibrosis (stages F2 to F3) have a 10-17 times higher risk of liver-related mortality compared to those without fibrosis, while those with cirrhosis face a 42 times higher risk [6] - An estimated 1.5 million patients in the U.S. have been diagnosed with MASH, with approximately 315,000 patients under the care of liver specialists having moderate to advanced fibrosis [7] Strategic Outlook and Growth Opportunities - The company is preparing for European expansion in the second half of 2025, pending EMA approval [5][13] - Positive results from the MAESTRO-NASH OUTCOMES trial could position Rezdiffra as the only treatment for F2 to F4 MASH and the only therapy with outcomes data this decade [13] Leadership and Communication - Bill Sibold, CEO of Madrigal, will present updates at the 43rd Annual J.P. Morgan Healthcare Conference on January 15, 2025, via a live webcast [2][4]