Shares of Madrigal Pharmaceuticals (MDGL 17.62%) were soaring 15.2% higher as of 11:05 a.m. ET on Wednesday. The big gain came after the small biopharmaceutical company announced its fourth-quarter and full-year 2024 results before the market opened.Madrigal reported fourth-quarter revenue of $103.3 million, all of which stemmed from sales of Rezdiffra, the first drug approved for treating metabolic dysfunction-associated steatohepatitis (MASH). The company posted a net loss in Q4 of $59.4 million, or $2.71 ...

Fourth-Quarter and Full-Year 2024 Financial Results Feb. 26, 2025 NASDAQ: MDGL Forward-Looking Statements This presentation includes "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, that are based on Madrigal's beliefs and assumptions and on information currently available to it but are subject to factors beyond its control. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectation ...

Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) Q4 2024 Earnings Conference Call February 26, 2025 8:00 AM ET Company Participants Tina Ventura - Chief Investor Relations Officer Bill Sibold - CEO, President & Director Mardi Dier - CFO & Senior VP Michael Charlton - Head of Clinical Development Conference Call Participants Thomas Smith - Leerink Partners Andrea Newkirk - Goldman Sachs Yasmeen Rahimi - Piper Sandler Ellie Merle - UBS Amy Li - Jefferies Liisa Bayko - Evercore ISI David Lebowitz - Citi Andy Chen ...

Madrigal (MDGL) came out with a quarterly loss of $2.71 per share versus the Zacks Consensus Estimate of a loss of $4.12. This compares to loss of $5.68 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 34.22%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $6.94 per share when it actually produced a loss of $4.92, delivering a surprise of 29.11%.Over the last four quarters, the company h ...

Research and Development - The company has incurred significant research and development costs, including internal costs and external services, but specific figures for the last three fiscal years are referenced in the annual report[74]. - The company must demonstrate safety and efficacy through well-controlled clinical trials, which are expensive and time-consuming, with uncertain outcomes[203]. - The company has committed to completing the MAESTRO-NASH trial to demonstrate the clinical benefit of Rezdiffra, which is a 54-month outcomes trial[165]. - Challenges in patient enrollment for clinical trials could lead to increased costs and delay commercialization of products[216]. - The company anticipates significant costs associated with seeking full approval of Rezdifra and commercialization efforts[248]. Manufacturing and Supply Agreements - The company relies on third-party contract manufacturers for all required materials and finished products, with no plans to establish its own manufacturing facilities[75]. - A Commercial Supply Agreement with Evonik Corporation was entered into for the manufacturing and supply of resmetirom, with an initial term expiring on December 31, 2029[76]. - The company has also established a Commercial Supply Agreement with UPM Pharmaceuticals for the primary supply of Rezdiffra tablets in the U.S., expiring in April 2032[76]. - The company relies on third-party manufacturers for the production of Rezdifra, which entails risks that could negatively impact commercial operations[237]. - The company may face manufacturing delays and limitations on supply availability due to third-party constraints and external factors[238]. Intellectual Property and Regulatory Compliance - As of December 31, 2024, the company owns or co-owns eight U.S. issued patents and 103 foreign issued patents related to resmetirom, with pending applications expected to expire in 2044[80]. - The company’s issued patents for resmetirom have expiration dates between 2026 and 2038, with pending applications potentially extending to 2044[81]. - The company’s success is contingent on obtaining and maintaining patent protection and avoiding infringement on others' proprietary rights[79]. - Regulatory compliance is essential for the continued approval and commercialization of Rezdiffra, with potential sanctions for non-compliance[182]. - The company may face risks related to intellectual property protection in foreign jurisdictions, which could lead to competitive disadvantages[228]. FDA and Drug Approval Process - The FDA regulates the drug approval process, requiring substantial time and financial resources for compliance[86]. - Human clinical trials are conducted in three phases, with Phase 3 trials typically requiring two adequate and well-controlled studies for FDA approval[90]. - The FDA's PDUFA performance goals generally provide for action on an NDA within 10 months of the 60-day filing date, which can be shortened to 6 months for priority review products[93]. - The FDA may issue a complete response letter (CRL) outlining deficiencies in the submission, which may require additional clinical data or impose other conditions for NDA approval[94]. - Accelerated approval pathways require confirmatory post-marketing clinical trials, and approval may be withdrawn if these trials fail to verify clinical benefit[96]. Market and Competitive Landscape - The commercial success of Rezdiffra is contingent on effective education of healthcare providers and patients regarding its benefits and risks[163]. - The market acceptance of Rezdiffra is critical for revenue generation, influenced by factors such as physician willingness to prescribe and patient demographics[166]. - Rezdiffra is currently the only FDA-approved drug for the treatment of MASH, but over 150 competing drugs are in development, increasing competitive pressure[186]. - The company faces significant competition from entities with greater resources and experience in the biopharmaceutical industry, which could affect its market position[185]. - The potential market size for Rezdiffra may be overstated, and reliance on third-party data to identify physicians could limit market opportunities[196][197]. Financial Condition and Funding - The company has an accumulated deficit of $1,802.2 million as of December 31, 2024, primarily due to costs from commercialization efforts and clinical trials[244]. - The company currently has cash, cash equivalents, restricted cash, and marketable securities of approximately $931.3 million as of December 31, 2024[244]. - The company expects to continue incurring operating losses as it supports sales and marketing efforts for Rezdiffra and fulfills post-marketing commitments[244]. - The company may need to raise substantial additional funds in the future to support operations and commercialization efforts[252]. - The company’s financial condition and operating results may fluctuate significantly, impacting stock price and funding ability[254]. Healthcare Regulations and Pricing - The U.S. government has implemented measures that may reduce the profitability of drug products, including increased rebates for drugs reimbursed by Medicaid programs[130]. - The company faces significant uncertainty regarding coverage and reimbursement status from third-party payors, which can affect product sales[125]. - The Inflation Reduction Act of 2022 includes a $2,000 out-of-pocket cap for Medicare Part D beneficiaries, which may impact the company's business depending on its implementation[133]. - The company must comply with various pricing regulations, including the 340B Drug Pricing program and the Federal Ceiling Price requirements[151][153]. - The company faces complex pricing and rebate calculations that could affect its financial results and compliance costs[266]. Employee and Operational Considerations - As of December 31, 2024, the company had 528 full-time employees, with 136 in research and development, 312 in commercial activities, and 80 in general and administrative functions[154]. - The company expects to increase its headcount in 2025 to support U.S. infrastructure growth and expand commercial activities in Europe, pending approval of Rezdiffra by the EC[154]. - The company is dependent on retaining key personnel, and the loss of such individuals could adversely affect business operations and stock price[220]. - The ability to effectively train and equip commercial personnel is crucial for the successful marketing of Rezdiffra[30]. - Strategic transactions may not be clinically or commercially successful, potentially requiring significant cash and adversely affecting the company's financial condition[224].

Financial Performance - Madrigal Pharmaceuticals reported preliminary fourth-quarter 2024 net sales of Rezdiffra™ (resmetirom) in the range of $100 million to $103 million[4] - For the full year 2024, net sales of Rezdiffra™ are estimated to be between $177 million and $180 million[4] - The preliminary financial results are unaudited and subject to adjustment, with final results expected to be announced in February 2025[5] Cash Position - As of December 31, 2024, the company reported approximately $931 million in cash, cash equivalents, restricted cash, and marketable securities[4]

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]

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]