MDGL Stock Down 10% on Disappointing Preliminary Q4 Rezdiffra Sales

Core Insights - Madrigal Pharmaceuticals (MDGL) shares fell by 9.7% following disappointing preliminary fourth-quarter and full-year 2024 results, primarily driven by product revenues from its marketed drug, Rezdiffra [1][3] Financial Performance - Preliminary fourth-quarter 2024 revenues from Rezdiffra sales are estimated to be between $100 million and$103 million [3] - For the full year 2024, preliminary revenues from Rezdiffra sales are projected to be in the range of $177 million to$180 million since its launch in April 2024 [3] - As of year-end 2024, over 11,800 patients are reported to be on Rezdiffra treatment [3] - The company's cash, cash equivalents, restricted cash, and marketable securities are approximately $931 million [4] Product Development and Regulatory Updates - Rezdiffra received FDA's accelerated approval in March 2024 for adult patients with nonalcoholic steatohepatitis (NASH), becoming the first FDA-approved therapy targeting the underlying causes of NASH [2][6] - A regulatory filing for Rezdiffra's approval in the EU is under review, with a final decision expected in mid-2025, followed by a country-by-country launch starting in Germany in the second half of 2025 [6] - The ongoing pivotal phase III MAESTRO-NASH biopsy study aims to provide long-term safety and efficacy data to support full approval of Rezdiffra for noncirrhotic NASH [7] - A second phase III outcomes study is evaluating Rezdiffra's effectiveness in patients with well-compensated NASH cirrhosis, which could broaden its eligible patient group [8][9] Market Performance - Over the past three months, Madrigal shares have increased by 27.1%, contrasting with an 11.7% decline in the industry [2]