Core Insights - Madrigal Pharmaceuticals reported positive two-year results from the Phase 3 MAESTRO-NAFLD-1 trial of Rezdiffra, showing significant reductions in liver stiffness in patients with compensated MASH cirrhosis [1][2][4] Group 1: Trial Results - The trial included an open-label active treatment arm with 101 patients, achieving a mean reduction in liver stiffness of 6.7 kPa after two years, compared to a baseline of 25 kPa [2][6] - This reduction is the largest reported in an F4c MASH population, indicating a significant clinical improvement [2][6] - A responder analysis showed that 51% of patients achieved a ≥25% improvement in liver stiffness, which is associated with reduced progression to end-stage liver disease [3][6] Group 2: Safety and Efficacy - The safety profile of Rezdiffra in this cohort was consistent with previous trials, showing a low rate of discontinuations due to adverse events [4][5] - The ongoing MAESTRO-NASH OUTCOMES trial aims to further evaluate the efficacy of Rezdiffra in patients with compensated MASH cirrhosis, with the potential to become the first approved therapy for this indication [5][18] Group 3: Market Context - MASH is a serious liver disease that can progress to cirrhosis and has a high unmet medical need, with an estimated 1.5 million diagnosed patients in the U.S. [8][10] - Patients with compensated MASH cirrhosis face a 42 times higher risk of liver-related mortality, highlighting the urgency for effective treatments [9][10] - Madrigal aims to reach approximately 315,000 patients with moderate to advanced fibrosis under the care of liver specialists as awareness and prevalence of MASH increase [10][18]

Group 1 - Madrigal Pharmaceuticals will participate in the 45th Annual TD Cowen Health Care Conference on March 4, 2025, at 11:10 A.M. ET [1] - The presentation will be available via live webcast and a replay will be accessible after the event [1] - Madrigal Pharmaceuticals focuses on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with significant unmet medical needs [2] Group 2 - The company's primary medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist aimed at addressing the underlying causes of MASH [2]

Core Viewpoint - Madrigal Pharmaceuticals, Inc. is set to release its fourth-quarter and full-year 2024 financial results on February 26, 2025, before the U.S. markets open [1] Company Overview - Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a biopharmaceutical company focused on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with significant unmet medical needs [3] - The company's primary medication, Rezdiffra (resmetirom), is a once-daily oral THR-β agonist aimed at addressing the underlying causes of MASH [3] Investor Relations - A live webcast to discuss the financial and operating results will be hosted by Madrigal's management at 8 a.m. Eastern Time on the same day as the financial results release [1] - Participants are encouraged to register at least 15 minutes prior to the webcast for a timely connection, and the webcast will be available for viewing approximately two hours after the live event [2]

Core Insights - Madrigal Pharmaceuticals reported preliminary financial results that exceeded analyst expectations, yet the stock price declined nearly 20% in the past week, indicating high investor expectations [1][2]. Financial Performance - The company announced preliminary earnings of $100 million to $103 million for Q4 from its drug Rezdiffra, aimed at treating metabolic dysfunction-associated steatohepatitis (MASH) [2]. - For the full year 2024, Madrigal projected revenues from Rezdiffra to be between $177 million and $180 million, with over 11,800 patients using the medication by year-end [2]. Analyst Ratings - Analyst expectations were surpassed, leading to bullish updates from analysts. Goldman Sachs maintained a buy recommendation with a price target of $530, while Evercore ISI raised its fair value estimate from $360 to $392, also maintaining an outperform rating [3]. Market Reaction - Despite positive financial indicators and analyst optimism, the stock experienced selling pressure, suggesting that investors may be overly optimistic about Rezdiffra's growth potential or are impatient for the drug to demonstrate higher growth rates [4].

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]

Core Viewpoint - Madrigal Pharmaceuticals' shares fell by 13.3% following the announcement of preliminary fourth-quarter and full-year 2024 results, despite beating analyst estimates for revenue [1][3]. Financial Performance - Preliminary Q4 net sales for the metabolic steatohepatitis (MASH) drug Rezdiffra were reported between $100 million and $103 million, while full-year 2024 net sales were between $177 million and $180 million [2]. - The company expects to end 2024 with approximately $931 million in cash, cash equivalents, restricted cash, and marketable securities [2]. Market Expectations - Analysts had estimated Q4 revenue at nearly $91.8 million and full-year revenue at around $168.3 million, which Madrigal surpassed [3]. - The decline in stock price was attributed to Madrigal not meeting higher "whisper numbers" that investors had anticipated, despite the official estimates being exceeded [4]. Product Launch and Future Prospects - Rezdiffra is in the early stages of its U.S. launch, having received regulatory approval in March 2024, and is the only approved treatment for MASH in the U.S. [5]. - The company is also preparing for a European launch in the second half of 2025, with ongoing clinical trials for Rezdiffra in compensated cirrhosis potentially serving as a catalyst for future growth [5].

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]

Core Insights - Madrigal Pharmaceuticals has reported a transformational year in 2024, highlighted by the FDA approval of Rezdiffra as the first and only treatment for metabolic dysfunction-associated steatohepatitis (MASH) [2] - The company has successfully enrolled over 11,800 patients on Rezdiffra, indicating strong market demand and execution [2][6] - Madrigal is preparing for European expansion in the second half of 2025, following the anticipated EMA decision on Rezdiffra [2][7] Financial Performance - Preliminary fourth-quarter 2024 net sales for Rezdiffra are estimated to be between $100 million and $103 million, while full-year 2024 sales are projected to be between $177 million and $180 million [6][7] - As of year-end 2024, Madrigal's cash, cash equivalents, restricted cash, and marketable securities total approximately $931 million [6][7] Market Context - MASH is expected to become the leading cause of liver transplants in the U.S., with an estimated 1.5 million diagnosed patients, and Madrigal aims to reach around 315,000 patients with moderate to advanced fibrosis [5][9] - The MAESTRO-NASH OUTCOMES trial could further position Rezdiffra as a key treatment option for patients with compensated cirrhosis, addressing a significant unmet medical need [2][7]

Group 1 - The core viewpoint is that Madrigal Pharmaceuticals has experienced a significant stock increase of over 60% since April 2024, attributed to strong sales performance of its product Rezdiffra in the metabolic-associated steatohepatitis (MASH) market [1] - The first two quarters of Rezdiffra sales have exceeded estimates, indicating a successful product launch [1] Group 2 - The article emphasizes the importance of trading around key events such as trial results and NDA/BLA approvals in the biotech sector [1]

Company Presentation - Madrigal Pharmaceuticals will present at the 43rd Annual J P Morgan Healthcare Conference on January 15 2025 at 2 15 pm PT [1] - The presentation will be webcast live and accessible via Madrigalâs Investor Relations Site Events and Presentations [1] Company Overview - Madrigal Pharmaceuticals is a biopharmaceutical company focused on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) a liver disease with significant unmet medical needs [2] - The companyâs lead medication Rezdiffra (resmetirom) is a once-daily oral liver-directed THR-β agonist designed to target key underlying causes of MASH [2] Contact Information - Investor inquiries can be directed to Tina Ventura at IR@madrigalpharma com [3] - Media inquiries can be directed to Christopher Frates at media@madrigalpharma com [3]