Core Insights - Madrigal Pharmaceuticals, Inc. will participate in three upcoming investor conferences, showcasing its commitment to engaging with investors and stakeholders in the healthcare sector [1][2][3] Conference Participation - The company will present at the Jefferies Global Healthcare Conference in London on November 20, 2025, at 8:30 A.M. GMT [1] - Madrigal will also participate in the 8th Annual Evercore Healthcare Conference on December 2, 2025, at 4:15 P.M. ET [2] - Additionally, the company is scheduled to present at the Piper Sandler 37th Annual Healthcare Conference on December 3, 2025, at 1:30 P.M. ET [3] Company Overview - Madrigal Pharmaceuticals focuses on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with significant unmet medical needs [4] - The company's lead medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist, and is the first and only medication approved by both the FDA and European Commission for treating MASH with moderate to advanced fibrosis (F2 to F3) [4] - An ongoing Phase 3 outcomes trial is assessing Rezdiffra for the treatment of compensated MASH cirrhosis (F4c) [4]

Core Insights - Madrigal Pharmaceuticals announced positive two-year data from the Phase 3 MAESTRO-NAFLD-1 trial for Rezdiffra, targeting compensated MASH cirrhosis patients, a population with no approved therapies [1][3][4] - The data presented at the AASLD meeting highlighted significant improvements in liver stiffness, liver enzymes, and biomarkers in patients with advanced compensated MASH cirrhosis [2][6][8] Company Overview - Madrigal Pharmaceuticals focuses on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) [23] - Rezdiffra (resmetirom) is the first approved medication for treating MASH with moderate to advanced fibrosis in the U.S. and Europe [12][23] Clinical Trial Results - In the MAESTRO-NAFLD-1 trial, Rezdiffra showed statistically significant improvements in multiple imaging and biomarker parameters over two years in patients with compensated MASH cirrhosis [4][6] - Patients with platelet counts <100,000/µL demonstrated notable improvements, with a mean reduction in liver stiffness of -7.9 kPa [5][7] - Following two years of treatment, 39% of patients shifted to no/low CSPH risk scores, indicating a positive trend in disease management [7] Health-Related Quality of Life - Rezdiffra treatment resulted in significant and sustained improvements in health-related quality of life measures across various domains for both cirrhotic and non-cirrhotic patients [9][10] - Improvements were observed in fatigue, worry, emotional function, and abdominal symptoms, enhancing overall patient well-being [10][12] Safety and Tolerability - Rezdiffra was well-tolerated in the high-risk patient population, with a low rate of discontinuation due to adverse events [8][12] - No significant changes in bone mineral density or fracture risk were noted over the two-year treatment period [8] Future Directions - Madrigal is executing a fully enrolled Phase 3 outcomes study for Rezdiffra in compensated MASH cirrhosis patients, reinforcing its commitment to addressing this unmet medical need [3][12] - Continuous treatment with Rezdiffra is emphasized as necessary to maintain benefits and prevent disease progression, similar to management strategies for chronic diseases [12]

Core Insights - Madrigal Pharmaceuticals (MDGL) reported a third-quarter 2025 loss of $5.08 per share, which is wider than the Zacks Consensus Estimate of a loss of $1.98, and compared to a loss of $4.92 per share in the same quarter last year [1][6] - The company generated total revenues of $287.3 million from product sales of its MASH drug Rezdiffra, surpassing the Zacks Consensus Estimate of $249 million, indicating strong year-over-year growth driven by increased demand [2][6] - MDGL shares increased by 7.8% following the announcement of strong sales growth [3] Financial Performance - Research and development expenses more than doubled to $174 million in Q3 2025, primarily due to upfront expenses for CSPC Pharma, partially offset by reduced clinical study expenses [5] - Selling, general and administrative expenses nearly doubled to $209.1 million, attributed to increased commercial launch activities for Rezdiffra [8] - Madrigal's cash, cash equivalents, and marketable securities amounted to $1.1 billion as of September 30, 2025, up from $802 million as of June 30, 2025, reflecting a new $350 million senior secured term loan with Blue Owl Capital [9] Product and Market Updates - Rezdiffra received accelerated approval from the FDA in March 2024, becoming the first and only approved therapy for MASH, with over 29,500 patients currently receiving treatment and more than 10,000 healthcare providers prescribing it as of September 30, 2025 [4][10] - The European Commission granted conditional marketing authorization to Rezdiffra in August 2025, making it the first approved therapy for MASH in the EU, with a launch in Germany in September [10] - Madrigal finalized a global licensing deal with CSPC Pharma for MGL-2086, an oral GLP-1 agonist, to combine with Rezdiffra in MASH treatment, with clinical entry expected in the first half of 2026 [11] Ongoing Studies and Future Prospects - The FDA's continued approval of Rezdiffra will depend on long-term safety and efficacy data from the ongoing pivotal phase III MAESTRO-NASH biopsy study [12] - A second phase III outcomes study (MAESTRO-NASH OUTCOMES) is underway, with top-line data expected in 2027, which could support full approval for Rezdiffra and expand its eligible patient population [13] - Positive two-year data from the open-label extension of the MAESTRO-NAFLD-1 study reinforces Rezdiffra's potential benefits for patients with compensated MASH cirrhosis [14]

Core Insights - Madrigal Pharmaceuticals, Inc. is focused on developing therapies for cardiovascular and metabolic diseases, with its product Rezdiffra gaining market traction despite competition [1] Financial Performance - The company reported a quarterly EPS of -$5.08, missing the estimated EPS of -$2.04, and this loss increased slightly from -$4.92 per share in the same quarter last year [2][6] - Madrigal's revenue for the quarter was $287.3 million, exceeding the estimated $244.96 million, and showing significant growth from $62.17 million reported a year ago [3][6] Market Position and Strategy - Over 29,500 patients are currently using Rezdiffra, indicating strong market acceptance [3] - The company entered a global licensing agreement with CSPC Pharma to incorporate an oral GLP-1 into its offerings, and a new patent for Rezdiffra extends its protection until 2045 [4] - The launch of Rezdiffra in Germany following European Commission approval further expands its market reach [4] Financial Health - Madrigal has a negative P/E ratio of -35.13, indicating a lack of profitability, but maintains a strong current ratio of 5.11, demonstrating good short-term liability coverage [5] - The company has cash reserves totaling $1.1 billion, providing a solid financial foundation for ongoing operations and strategic initiatives [5][6]

Rezdiffra Sales Performance - Rezdiffra's net sales for 3Q25 reached $287.3 million[13], annualizing at over $1 billion[9, 13] - From 2Q25 to 3Q25, Rezdiffra experienced a quarter-over-quarter growth of 35%[13] - Over 29,500 patients are currently on Rezdiffra[9, 16] - More than 10,000 healthcare providers have prescribed Rezdiffra to date[9, 19] Market and Pipeline Expansion - Madrigal is advancing Rezdiffra in a compensated MASH cirrhosis (F4c) trial, aiming to be first to market[11] - The company completed the transaction of oral GLP-1 (MGL-2086)[11] - Data from the MAESTRO-NASH OUTCOMES trial (F4c) is expected in 2027[37], and MAESTRO-NASH (F2/F3) data is expected in 2028[37] - MGL-2086/resmetirom combo is expected to enter clinic in the first half of 2026[37] - Rezdiffra has broad first-line access with no step edit requirements and improvements in utilization management criteria[31] Financial Position - Madrigal reported $1.1 billion in cash, cash equivalents, restricted cash, and marketable securities as of September 30, 2025[46] - Net product revenue for 3Q25 was $287.268 million, compared to $62.175 million in 3Q24[44] - The net loss for 3Q25 was ($114.190) million, compared to ($106.964) million in 3Q24[44]

Core Insights - Madrigal Pharmaceuticals reports strong growth in third-quarter 2025, with net revenues of $287.3 million, a significant increase from $62.2 million in the same period last year, driven by the demand for Rezdiffra [4][5] - The company has over 29,500 patients currently on Rezdiffra therapy, with more than 10,000 healthcare providers prescribing it, indicating a successful launch and market penetration [2][5] - Madrigal is advancing its strategy to build a pipeline of complementary therapies, including a newly licensed oral GLP-1 therapy, to enhance treatment efficacy for metabolic dysfunction-associated steatohepatitis (MASH) [2][6] Financial Performance - Total revenues for Q3 2025 reached $287.3 million, compared to $62.2 million in Q3 2024, reflecting a substantial increase due to heightened demand for Rezdiffra [4][16] - Operating expenses for Q3 2025 were $401.2 million, up from $178.5 million in the prior year, primarily due to increased commercial activities and R&D expenses [12][16] - The net loss for Q3 2025 was $114.2 million, compared to a net loss of $107.0 million in Q3 2024, with a basic and diluted net loss per share of $5.08 [12][17] Corporate Developments - Madrigal launched Rezdiffra in Germany following European Commission approval, marking it as the first and only approved therapy for MASH in the EU [6][11] - The company has secured a new patent for Rezdiffra, providing protection until 2045, which supports its long-term strategy in the MASH market [6][12] - Madrigal is preparing for a significant presence at the upcoming AASLD Liver Meeting, with 15 abstracts accepted, showcasing its commitment to advancing research in liver diseases [6][11] Market Context - MASH is a serious liver disease that can lead to severe complications, including cirrhosis and liver failure, with a growing patient population in need of effective treatments [8][10] - The company aims to reach approximately 315,000 patients with moderate to advanced fibrosis in the U.S., highlighting the substantial market opportunity for Rezdiffra [9][10]

Core Insights - Madrigal Pharmaceuticals is presenting new data on Rezdiffra (resmetirom) for treating metabolic dysfunction-associated steatohepatitis (MASH) at the upcoming AASLD Liver Meeting, highlighting its potential for advanced patients with compensated cirrhosis [1][2][4] Company Overview - Madrigal Pharmaceuticals focuses on developing novel therapeutics for MASH, a liver disease with significant unmet medical needs [19] - Rezdiffra is the first approved medication for MASH in the U.S. and Europe, targeting key underlying causes of the disease [6][19] Clinical Data and Presentations - The company will present two oral presentations and multiple posters at the AASLD meeting, including data on biomarkers, imaging, and quality of life improvements in patients treated with Rezdiffra [4][5] - Key presentations include: - "Two-Year Time Course of Biomarker and Imaging Responses in Well-Compensated MASH Cirrhosis Patients Treated with Resmetirom" [5] - "Improvement in Health-Related Quality of Life in Non-Cirrhotic and Cirrhotic Patients with MASH Treated with Resmetirom" [5] Treatment Efficacy - In the pivotal Phase 3 MAESTRO-NASH trial, Rezdiffra demonstrated significant improvements in fibrosis and MASH resolution, with 91% of patients showing improvement or stabilization of liver stiffness after one year [6][19] - The ongoing Phase 3 MAESTRO-NASH-OUTCOMES trial is evaluating Rezdiffra's efficacy in patients with compensated MASH cirrhosis [2][19] Disease Context - MASH is a serious liver disease that can progress to cirrhosis and liver failure, with increasing prevalence leading to a higher number of diagnosed patients [8][10] - Patients with moderate to advanced fibrosis face significantly higher risks of liver-related mortality, emphasizing the need for effective treatments [9]

Core Viewpoint - Madrigal Pharmaceuticals, Inc. is set to release its third-quarter 2025 financial results on November 4, 2025, before the U.S. financial markets open [1] Group 1: Financial Results Announcement - The financial results will be followed by a live webcast hosted by Madrigal's management at 8 a.m. Eastern Time [2] - Participants are encouraged to register at least 15 minutes prior to the webcast for a timely connection [2] Group 2: Company Overview - Madrigal Pharmaceuticals focuses on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with significant unmet medical needs [3] - The company's medication, Rezdiffra (resmetirom), is the first and only FDA and European Commission approved treatment for MASH with moderate to advanced fibrosis (F2 to F3) [3] - An ongoing Phase 3 outcomes trial is assessing Rezdiffra for the treatment of compensated MASH cirrhosis (F4c) [3]

Core Insights - Madrigal Pharmaceuticals, Inc. has granted equity awards to 27 new non-executive employees as part of its 2025 Inducement Plan, approved by the independent Compensation Committee [1][2] Company Overview - Madrigal Pharmaceuticals focuses on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with significant unmet medical needs [3] - The company's medication, Rezdiffra (resmetirom), is the first and only FDA and European Commission approved treatment for MASH with moderate to advanced fibrosis (F2 to F3) [3] - An ongoing Phase 3 trial is assessing Rezdiffra for the treatment of compensated MASH cirrhosis (F4c) [3] Equity Awards Details - The equity awards granted include options to purchase a total of 1,602 shares and 10,973 time-based restricted stock units [2] - The options have an exercise price of $449.14 per share, equal to the closing price on the grant date [2] - Vesting schedule for options includes 25% on the first anniversary and 6.25% quarterly thereafter, while restricted stock units vest in four equal installments over four years [2]

Core Insights - Madrigal Pharmaceuticals has emerged as a significant player in the treatment of metabolic liver diseases with its drug Rezdiffra (resmetirom), which is approved for F2-F3 MASH and shows potential for blockbuster sales [1] Company Overview - Rezdiffra (resmetirom) has received accelerated approval in the US, indicating a fast-tracked pathway for drugs that address unmet medical needs [1] Market Potential - The drug is already demonstrating strong market potential, suggesting that it could achieve blockbuster status despite the competitive landscape in metabolic liver disease treatments [1]