CONSHOHOCKEN, Pa., Sept. 03, 2025 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) today announced that the company will participate in the Morgan Stanley 23rd Annual Global Health Care Conference on Monday, Sept. 8, 2025 at 7:45 A.M. EDT. The presentation will be webcast live and may be accessed here or by visiting Madrigal’s Investor Relations Events and Presentations page. A replay of the webcast will be available after the event. About MadrigalMadrigal Pharmaceuticals, Inc. (Nasdaq: MDG ...

Core Insights - Madrigal Pharmaceuticals (MDGL) received conditional marketing authorization from the European Commission for Rezdiffra (resmetirom) to treat adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate-to-advanced liver fibrosis [1][7] - Rezdiffra is the first and only therapy approved for MASH in the European Union, based on positive data from the pivotal phase III MAESTRO-NASH study [2][3] - The first European launch of Rezdiffra is anticipated in Q4 2025, starting in Germany, and it is already included as a first-line treatment in European MASH guidelines [3] Market Performance - Year-to-date, shares of Madrigal have increased by 23%, outperforming the industry average rise of 9.1% [4] - Despite the EU approval, MDGL stock fell by 3% on August 19 due to investor concerns over competition from Novo Nordisk's Wegovy [6][7] Competitive Landscape - Wegovy, a GLP-1 drug from Novo Nordisk, received accelerated approval from the FDA for treating noncirrhotic MASH, marking it as the first GLP-1 therapy approved for this condition [8][9] - Analysts suggest Wegovy's established safety profile and benefits in metabolic disease may position it as a preferred treatment for MASH, potentially impacting Rezdiffra's market position [9] Sales and Demand - Rezdiffra's commercial launch in the U.S. has shown strong initial demand, generating sales of $212.8 million in Q2 2025, a sequential increase of nearly 55% [11] - As of June 30, 2025, over 23,000 patients are currently receiving treatment with Rezdiffra [11]

Core Viewpoint - Madrigal Pharmaceuticals has received conditional marketing authorization from the European Commission for Rezdiffra, making it the first approved therapy for metabolic dysfunction-associated steatohepatitis (MASH) in the European Union [1][10]. Company Overview - Madrigal Pharmaceuticals, Inc. is focused on developing novel therapeutics for MASH, a liver disease with significant unmet medical needs [12]. - Rezdiffra (resmetirom) is a once-daily, oral, liver-directed THR-β agonist designed to address the underlying causes of MASH [8][12]. Product Details - Rezdiffra is indicated for adults with noncirrhotic MASH with moderate to advanced liver fibrosis (F2-F3) [9][10]. - The European Commission's decision was based on positive results from the Phase 3 MAESTRO-NASH trial, which demonstrated fibrosis reduction and MASH resolution [3][6]. - At one year, 91% of patients treated with Rezdiffra 100 mg showed improvement or stabilization of liver stiffness [3]. Market Context - MASH is a leading cause of liver-related mortality and is increasingly burdening healthcare systems globally, with approximately 370,000 patients diagnosed in Europe [2][5]. - The approval of Rezdiffra is expected to set a precedent in the treatment of MASH, as it does not require a biopsy for treatment qualification [2][4]. Regulatory Approval - The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in June 2025 [4]. - Rezdiffra is included in European MASH treatment guidelines and is expected to launch in Germany in the fourth quarter of 2025 [4][6].

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Summary of Madrigal Pharmaceuticals (MDGL) FY Conference Call - August 12, 2025 Company Overview - **Company**: Madrigal Pharmaceuticals (MDGL) - **Product**: ResDiffera, a treatment for NASH (Non-Alcoholic Steatohepatitis) Key Industry Insights - **NASH Market**: The NASH market is expected to grow significantly, with Madrigal positioned as a leader due to its first approved drug in this space. - **Patient Population**: Approximately 245,000 patients with F4C (compensated cirrhosis) and 315,000 patients with F2F3 NASH are targeted, with a focus on deeper penetration in the F4C group due to their higher medical needs. Core Points and Arguments 1. **Patent Protection**: A new US patent extends protection until February 2045, providing a significant competitive advantage and allowing for strategic planning of future pipelines [3][17][18]. 2. **Sales Performance**: The company reported $213 million in sales for the last quarter, annualizing to over $800 million, with 80% of top targets prescribing ResDiffera [5][6]. 3. **Patient Adoption**: Over 23,000 patients are currently on therapy, indicating strong adoption and positive feedback from healthcare providers [5][6]. 4. **Clinical Efficacy**: Positive feedback from hepatologists indicates that ResDiffera is exceeding expectations in improving liver stiffness and other health metrics [9][10][11]. 5. **Commercial Strategy**: The company is focused on long-term education for providers and patients, ensuring understanding of NASH and the benefits of ResDiffera [13][14][15]. 6. **Combination Therapy**: The recent acquisition of an oral GLP-1 to combine with ResDiffera is expected to enhance efficacy by reducing liver fat and improving patient outcomes [35][36][37]. 7. **Market Positioning**: ResDiffera is positioned as a first-line therapy in EASL guidelines, with a strategic approach to launch in Germany and other European countries [49][50]. Additional Important Insights - **Real-World Data**: The company is leveraging real-world data from the US launch to inform its European strategy, aiming for a smooth rollout [51]. - **Off-Label Use**: There is some off-label use of ResDiffera in F4 patients, but the company is cautious about this until further study results are available [31][32]. - **Future Studies**: The Maestro Outcomes study is expected to provide further validation of ResDiffera's efficacy in 2027, which will be crucial for market confidence [26][30]. This summary encapsulates the key points discussed during the conference call, highlighting Madrigal Pharmaceuticals' strategic initiatives, market positioning, and the promising outlook for ResDiffera in the NASH treatment landscape.

Investor Contact Tina Ventura, IR@madrigalpharma.com Media Contact Christopher Frates, media@madrigalpharma.com CONSHOHOCKEN, Pa., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) today announced that the company will participate in the Canaccord Genuity 45 Annual Growth Conference on Tuesday, Aug. 12, 2025 at 10:30 A.M. EDT. The presentation will be webcast live and may be accessed here or by visiting Madrigal's Investor Relations Events and Presentations page. A replay of th ...

Financial Data and Key Metrics Changes - Madrigal Pharmaceuticals reported net sales of $213 million for Q2 2025, representing a 55% increase quarter-over-quarter [12][33] - The annualized net sales for ResDiffera are now exceeding $800 million, indicating strong demand and execution [12][37] - R&D expenses decreased to $54.1 million from $71.1 million year-over-year, primarily due to lower clinical trial costs [34] - SG&A expenses increased to $196.9 million from $105.4 million year-over-year, driven by higher commercial launch activities [35] Business Line Data and Key Metrics Changes - ResDiffera's quarterly run rate has surpassed $200 million, positioning it among the best specialty launches in the last decade [5] - The number of patients on ResDiffera increased to over 23,000, up from more than 17,000 at the end of Q1 2025 [12] - Physician penetration has reached 80% among the top 6,000 target prescribers, with 60% of a broader 14,000 target prescriber base having written prescriptions by the end of Q2 [14][15] Market Data and Key Metrics Changes - The U.S. market for ResDiffera is expected to expand significantly, with only about 7% of the 315,000 diagnosed F2F3 NASH patients currently being treated [13] - The company is preparing for international expansion, starting with Germany, where it estimates a target population of approximately 370,000 patients [25][26] Company Strategy and Development Direction - Madrigal is focused on maximizing ResDiffera's value and expanding its leadership in the NASH market through geographic expansion and new indications [4][6] - The company has secured a new U.S. patent extending protection for ResDiffera to February 2045, enhancing its long-term growth potential [9][11] - Plans to develop a combination therapy with a newly licensed oral GLP-1 are underway, aiming to optimize treatment for NASH patients [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing demand for ResDiffera and its ability to maintain growth despite potential competition from GLP-1 therapies [51][52] - The company anticipates that the upcoming GLP-1 launch will raise awareness and drive broader screening, ultimately benefiting ResDiffera [20][21] - Management highlighted the importance of maintaining a disciplined approach to gross-to-net dynamics as the company navigates its launch phase [44][46] Other Important Information - Madrigal has entered into a $500 million senior secured credit facility to support its ongoing launch and business development activities [36] - The company is preparing for a potential launch in Europe, with a focus on Germany, where it has already established a strong foundation [24][26] Q&A Session Summary Question: Can you expand on gross to net and inventory dynamics in the quarter? - Management indicated that gross to net will be choppy early in the launch, with expectations for more impact in the second half of the year [41][44] Question: How do you foresee maintaining growth with the entrance of GLP-1 therapies? - Management expects to continue adding patients and believes that the strong demand will persist through the GLP-1 launch [52][55] Question: Can you provide details on the selection process for the new oral GLP-1? - The selection was systematic, focusing on favorable stability and pharmacokinetic profiles, leading to the choice of SYH-2086 [61][62] Question: What is the expected launch curve in Europe compared to the U.S.? - Management believes that the European launch will benefit from prior preparation and existing guidelines, with revenue recognition expected more in 2026 [79] Question: Can you provide numbers around the gross to net range for specialty drugs? - Management confirmed that the gross to net range is expected to fall within 20% to 30%, based on extensive experience and current contracting negotiations [82][84]

Financial Data and Key Metrics Changes - Madrigal Pharmaceuticals reported net sales of $213 million for Q2 2025, representing a 55% increase quarter-over-quarter [13][37] - The annualized net sales for ResDiffera are now exceeding $800 million [13][37] - R&D expenses decreased to $54.1 million from $71.1 million year-over-year, primarily due to lower clinical trial costs [38] - SG&A expenses increased to $196.9 million from $105.4 million year-over-year, driven by higher commercial launch activities [38] Business Line Data and Key Metrics Changes - ResDiffera's quarterly run rate has surpassed $200 million, positioning it among the best specialty launches in the last decade [6][13] - The number of patients on ResDiffera increased to over 23,000, up from more than 17,000 at the end of Q1 2025 [13][14] - Physician penetration reached 80% among the top 6,000 target prescribers, with 60% of a broader 14,000 target prescriber base having written prescriptions by the end of Q2 [15][16] Market Data and Key Metrics Changes - The U.S. market for ResDiffera is expected to expand with the upcoming international launch in Germany, targeting approximately 370,000 diagnosed patients across Europe [26][28] - The company is preparing to expand into compensated NASH cirrhosis (F4C), which could potentially double ResDiffera's market opportunity in the U.S. [31] Company Strategy and Development Direction - Madrigal is focused on maximizing ResDiffera's value and expanding its leadership in the NASH market through geographic expansion and new indications [5][8] - The company has secured a new U.S. patent extending protection for ResDiffera until February 2045, enhancing its long-term growth potential [7][10] - A promising oral GLP-1 asset has been licensed to complement ResDiffera, with plans to enter clinical trials in the first half of next year [25][120] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong demand for ResDiffera and the potential for continued patient growth despite upcoming competition from GLP-1 therapies [56][57] - The company anticipates that the launch of semaglutide will raise awareness and drive broader screening, ultimately benefiting ResDiffera [22][23] - Management emphasized the importance of maintaining a disciplined approach to gross-to-net dynamics, expecting it to remain within the typical range for specialty medicines [48][49] Other Important Information - Madrigal has entered into a $500 million senior secured credit facility to support its ongoing launch and business development activities [40][41] - The company is preparing for a potential launch in Europe, with a focus on Germany as the first market [26][28] Q&A Session Summary Question: Can you expand on gross-to-net and inventory dynamics? - Management noted that gross-to-net will be choppy early in the launch, with expectations for more impact from contracting in the second half of the year [45][48] Question: How do you foresee maintaining growth with GLP-1 market entry? - Management expects strong demand to continue and is actively engaging with payers to establish partnerships, while also preparing for various scenarios regarding GLP-1 pricing and access [54][58] Question: Can you provide details on the new oral GLP-1 selection process? - The selection process was systematic, focusing on favorable chemical properties and pharmacokinetics, leading to the choice of SYH-2086 as a promising candidate for combination therapy [66][68] Question: What is the competitive landscape regarding GLP-1s? - Management believes that the familiarity with GLP-1s in the market will facilitate combination use, and they are focused on leveraging ResDiffera's unique profile to maintain a competitive edge [128][130]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________ FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-33277 _________________________ MADRIGAL PHARMACEUTICALS, INC. (Exact name of regist ...

NASDAQ: MDGL © 2025 Madrigal Pharmaceuticals, Inc. All rights reserved. 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 expectations regar ...