[Madrigal Pharmaceuticals Q2 2025 Earnings Report Overview](index=1&type=section&id=Madrigal%20Pharmaceuticals%20Q2%202025%20Earnings%20Report%20Overview) [Q2 2025 Performance Highlights and Strategic Progress](index=1&type=section&id=Q2%202025%20Performance%20Highlights%20and%20Strategic%20Progress) Madrigal achieved strong Q2 2025 results, driven by Rezdiffra demand, strategic patent extension, pipeline expansion, European market preparation, and balance sheet strengthening - CEO Bill Sibold stated the quarter's performance was "exceptional," primarily driven by sustained strong demand for Rezdiffra[3](index=3&type=chunk) - The company's strategy aims to secure Madrigal's long-term leadership in MASH by expanding Rezdiffra's coverage across fibrosis stages and regions, advancing complementary therapy pipelines, and creating sustained value for patients, providers, and shareholders[3](index=3&type=chunk) Q2 2025 Key Operational and Financial Highlights | Indicator | Data | | :------------------------------------------ | :------------------- | | Rezdiffra™ (resmetirom) Net Sales (Q2 2025) | $212.8 million | | Rezdiffra Patients (as of June 30, 2025) | Over 23,000 | | Cash, Cash Equivalents, Restricted Cash, and Marketable Securities (as of June 30, 2025) | $802.0 million | [Rezdiffra Commercial & IP Updates](index=1&type=section&id=Rezdiffra%20Commercial%20%26%20IP%20Updates) Madrigal secured a new US Rezdiffra patent extending protection until 2045, solidifying its market position with **$212.8 million** in Q2 2025 net sales and over **23,000** patients - The United States Patent and Trademark Office (USPTO) is expected to issue a new patent, 'Methods of Treating Fatty Liver Disease' (U.S. Patent No. 12,377,104), extending Rezdiffra's patent protection until February 4, 2045[4](index=4&type=chunk)[5](index=5&type=chunk)[6](index=6&type=chunk) - This patent covers the FDA-approved commercial weight-based dosing regimen for Rezdiffra and will be listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)[4](index=4&type=chunk)[6](index=6&type=chunk) - Rezdiffra™ (resmetirom) net sales were **$212.8 million** in Q2 2025[5](index=5&type=chunk) - Over **23,000** patients were on Rezdiffra as of June 30, 2025[5](index=5&type=chunk) [Pipeline Development & Financial Strengthening](index=2&type=section&id=Pipeline%20Development%20%26%20Financial%20Strengthening) Madrigal acquired global rights to oral GLP-1 candidate SYH2086 for MASH combination therapy and secured up to **$500 million** in non-dilutive credit to advance its pipeline - Announced a global licensing agreement with CSPC Pharma for worldwide rights to SYH2086, an oral GLP-1 development candidate, aiming to develop innovative MASH combination therapies[5](index=5&type=chunk)[6](index=6&type=chunk) - SYH2086 is expected to enter clinical trials in the first half of 2026[6](index=6&type=chunk) - Secured up to **$500 million** in senior secured credit to advance the MASH pipeline in a non-dilutive manner[5](index=5&type=chunk)[6](index=6&type=chunk) - The credit includes an initial **$350 million** term loan and a **$150 million** delayed draw term loan, with potential for up to **$250 million** in incremental loans to support potential strategic business development activities[6](index=6&type=chunk) [Regulatory & Clinical Achievements](index=2&type=section&id=Regulatory%20%26%20Clinical%20Achievements) Madrigal presented compelling two-year F4c data for Rezdiffra at EASL, supporting ongoing trials, and received a positive CHMP opinion for European MASH approval - Compelling two-year F4c data for Rezdiffra presented at EASL showed significant improvements in liver stiffness, risk of clinically significant portal hypertension, liver fat, liver enzymes, liver injury biomarkers, and lipids[5](index=5&type=chunk)[6](index=6&type=chunk) - These results further support the potential success of the ongoing MAESTRO-NASH OUTCOMES trial, with data expected in 2027[6](index=6&type=chunk) - The estimated market opportunity for the U.S. F4c MASH patient population is approximately **245,000** diagnosed patients under the care of a liver specialist[6](index=6&type=chunk) - Received a positive opinion from the CHMP recommending approval of Rezdiffra for MASH treatment in Europe, with an EC decision expected in August 2025[5](index=5&type=chunk)[6](index=6&type=chunk) [Corporate Governance Update](index=2&type=section&id=Corporate%20Governance%20Update) Dan Brennan was appointed to Madrigal's Board of Directors in August 2025, bringing extensive financial and corporate development experience - Dan Brennan was appointed to Madrigal's Board of Directors in August[5](index=5&type=chunk)[6](index=6&type=chunk) - Mr. Brennan previously served as Executive Vice President and Chief Financial Officer at Boston Scientific[6](index=6&type=chunk)[7](index=7&type=chunk) [Second-Quarter 2025 Financial Results](index=3&type=section&id=Second-Quarter%202025%20Financial%20Results) [Second-Quarter 2025 Financial Performance](index=3&type=section&id=Second-Quarter%202025%20Financial%20Performance) Madrigal achieved significant Q2 2025 revenue growth from Rezdiffra sales, substantially narrowing its net loss despite increased operating expenses, while maintaining a robust cash position Q2 2025 Key Financial Data (in thousands of USD) | Indicator | Q2 2025 | Q2 2024 | YOY Change (thousands of USD) | YOY Change (%) | | :-------------------------- | :------------- | :------------- | :----------------- | :------------ | | Total Revenue | 212,802 | 14,638 | 198,164 | 1353.8% | | Operating Expenses | 260,004 | 177,175 | 82,829 | 46.8% | | Operating Loss | (47,202) | (162,537) | 115,335 | -70.9% | | Net Loss | (42,281) | (151,971) | 109,690 | -72.2% | | Net Loss Per Share, Basic and Diluted | (1.90) | (7.10) | 5.20 | -73.2% | [Income Statement Analysis](index=3&type=section&id=Income%20Statement%20Analysis) Total revenue surged to **$212.8 million** in Q2 2025 due to Rezdiffra demand, with operating expenses rising to **$260.0 million**, resulting in a significantly narrowed net loss of **$42.3 million** Q2 2025 Income Statement Highlights (in thousands of USD) | Indicator | Q2 2025 | Q2 2024 | YOY Change (%) | | :-------------------------- | :------------- | :------------- | :------------ | | Net Product Revenue | 212,802 | 14,638 | +1357.5% | | Cost of Sales | 9,065 | 636 | +1324.0% | | Research and Development Expenses | 54,081 | 71,091 | -23.9% | | Selling, General and Administrative Expenses | 196,858 | 105,448 | +86.7% | | Total Operating Expenses | 260,004 | 177,175 | +46.7% | | Operating Loss | (47,202) | (162,537) | -70.9% | | Interest Income | 8,227 | 14,222 | -42.2% | | Interest Expense | (3,264) | (3,656) | -10.7% | | Net Loss | (42,281) | (151,971) | -72.2% | | Net Loss Per Share, Basic and Diluted | (1.90) | (7.10) | -73.2% | - Revenue growth is attributed to increased demand for Rezdiffra[11](index=11&type=chunk) - The decrease in R&D expenses is primarily due to reduced clinical trial costs[11](index=11&type=chunk) - The increase in SG&A expenses is primarily due to increased Rezdiffra commercial activities and personnel supporting commercialization[11](index=11&type=chunk) - The decrease in interest income is primarily due to lower cash balances[11](index=11&type=chunk) - The decrease in interest expense is primarily due to lower interest rates in 2025[11](index=11&type=chunk) [Balance Sheet Overview](index=3&type=section&id=Balance%20Sheet%20Overview) Madrigal's total assets slightly decreased to **$1.015 billion** as of June 30, 2025, with cash and equivalents at **$802.0 million** due to operational investments, and increased net accounts receivable Balance Sheet Highlights (in thousands of USD) | Indicator | June 30, 2025 | December 31, 2024 | Change (thousands of USD) | | :------------------------------------------ | :------------- | :------------- | :------------- | | Cash, Cash Equivalents, Restricted Cash, and Marketable Securities | 802,024 | 931,251 | (129,227) | | Net Accounts Receivable | 79,231 | 53,822 | 25,409 | | Total Assets | 1,015,381 | 1,042,247 | (26,866) | | Current Liabilities | 196,503 | 169,277 | 27,226 | | Stockholders' Equity | 695,978 | 754,383 | (58,405) | - The decrease in cash, cash equivalents, restricted cash, and marketable securities is due to investments in operating capital[11](index=11&type=chunk) [Disease and Product Information](index=3&type=section&id=Disease%20and%20Product%20Information) [Understanding MASH](index=3&type=section&id=Understanding%20MASH) MASH is a severe liver disease progressing to cirrhosis, liver failure, and cancer, with high mortality risk for patients with moderate to advanced fibrosis (F2-F3) and significantly higher risk for F4c - MASH (Metabolic Dysfunction-Associated Steatohepatitis) is a severe liver disease that can progress to cirrhosis, liver failure, liver cancer, the need for liver transplant, and premature death[10](index=10&type=chunk) - MASH is the leading cause of liver transplant in women in the U.S., the second leading cause of all liver transplants in the U.S., and the fastest-growing indication for liver transplant in Europe[10](index=10&type=chunk) - MASH patients with moderate to advanced liver fibrosis (F2 to F3) have a **10- to 17-fold** higher risk of liver-related mortality[11](index=11&type=chunk) - MASH patients who progress to cirrhosis (F4c) have a **42-fold** higher risk of liver-related mortality[12](index=12&type=chunk) - Madrigal targets approximately **315,000** moderate to advanced fibrosis patients and approximately **245,000** compensated MASH cirrhosis (F4c) patients under the care of a liver specialist in the U.S.[12](index=12&type=chunk) - The number of diagnosed F2 to F4c MASH patients is expected to grow with increasing disease awareness and prevalence[13](index=13&type=chunk) [About Rezdiffra (resmetirom)](index=4&type=section&id=About%20Rezdiffra%20%28resmetirom%29) Rezdiffra is the first and only FDA-approved daily oral, liver-targeted THR-β agonist for MASH adults with moderate to advanced liver scarring (F2-F3) without cirrhosis, used with diet and exercise - Rezdiffra is a prescription medicine used with diet and exercise to treat adults with noncirrhotic nonalcoholic steatohepatitis (NASH, now MASH) with moderate to advanced liver scarring (fibrosis) but not cirrhosis[14](index=14&type=chunk) - Rezdiffra is the first and only FDA-approved medication for MASH with moderate to advanced fibrosis (F2 to F3 stage)[19](index=19&type=chunk) - Rezdiffra is a once-daily, oral, liver-targeted THR-β agonist designed to target the key underlying causes of MASH[19](index=19&type=chunk) [Rezdiffra Indication and Usage](index=4&type=section&id=Rezdiffra%20Indication%20and%20Usage) Rezdiffra is an FDA-approved prescription for MASH adults with moderate to advanced liver fibrosis (F2-F3) without cirrhosis, used with diet and exercise, with efficacy based on MASH and liver scarring improvement - Rezdiffra is indicated for use with diet and exercise to treat adults with noncirrhotic nonalcoholic steatohepatitis (NASH, now MASH) with moderate to advanced liver scarring (fibrosis) but not cirrhosis[14](index=14&type=chunk) - This indication is approved based on improvement of NASH and liver scarring, with ongoing studies to confirm Rezdiffra's clinical benefit[14](index=14&type=chunk) - The safety and effectiveness of Rezdiffra in children (under 18 years of age) are not known[14](index=14&type=chunk) [Important Safety Information and Side Effects](index=4&type=section&id=Important%20Safety%20Information%20and%20Side%20Effects) Rezdiffra may cause serious side effects including liver injury and gallbladder problems; patients should report symptoms immediately, with common side effects including diarrhea and nausea - Rezdiffra may cause serious side effects, including liver injury (hepatotoxicity) and gallbladder problems (such as gallstones, inflammation of the gallbladder)[16](index=16&type=chunk)[21](index=21&type=chunk) - If symptoms of hepatotoxicity (e.g., fatigue, nausea, vomiting, jaundice, abdominal pain) occur, stop taking Rezdiffra immediately and contact a healthcare provider[21](index=21&type=chunk) - The most common side effects include diarrhea, nausea, itching, stomach (abdominal) pain, vomiting, dizziness, and constipation[17](index=17&type=chunk) - Rezdiffra is not recommended for co-administration with drugs such as gemfibrozil (used to lower triglycerides) or cyclosporine (used to suppress the immune system)[16](index=16&type=chunk) - Patients should inform their healthcare provider about all medical conditions (including liver or gallbladder problems, pregnancy or breastfeeding plans) and all medications they are taking[15](index=15&type=chunk)[16](index=16&type=chunk) [Additional Company Information](index=3&type=section&id=Additional%20Company%20Information) [About Madrigal Pharmaceuticals](index=5&type=section&id=About%20Madrigal%20Pharmaceuticals) Madrigal Pharmaceuticals is a biopharmaceutical company focused on novel MASH therapies, with Rezdiffra as the first and only FDA-approved drug for MASH with moderate to advanced fibrosis (F2-F3) - Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a biopharmaceutical company focused on delivering novel therapeutics for Metabolic Dysfunction-Associated Steatohepatitis (MASH)[19](index=19&type=chunk) - Rezdiffra (resmetirom) is a once-daily, oral, liver-targeted THR-β agonist designed to target the key underlying causes of MASH[19](index=19&type=chunk) - Rezdiffra is the first and only FDA-approved medication for MASH with moderate to advanced fibrosis (F2 to F3 stage)[19](index=19&type=chunk) - An ongoing Phase III outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c stage)[19](index=19&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements under the Private Securities Litigation Reform Act of 1995, subject to various risks and uncertainties, with no obligation to update - This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 safe harbor provisions[20](index=20&type=chunk) - Forward-looking statements are subject to various risks and uncertainties, including but not limited to: risks of obtaining and maintaining regulatory approvals, history of operating losses, possibility of achieving or maintaining profitability, achievement of clinical trial objectives, market demand and acceptance, financing capabilities, competitive trial results, cyberattacks, and changes in laws and regulations[20](index=20&type=chunk)[22](index=22&type=chunk) - Madrigal undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances[22](index=22&type=chunk) - Readers are advised to review Madrigal's filings with the U.S. Securities and Exchange Commission (SEC), particularly its Annual Report on Form 10-K for the year ended December 31, 2024, for more detailed information on risks and uncertainties[22](index=22&type=chunk) [Conference Call and Investor Relations](index=3&type=section&id=Conference%20Call%20and%20Investor%20Relations) Madrigal hosted a webcast on August 5, 2025, to review financial and operational results, with an archived webcast available on its investor relations website, and contact information provided - Madrigal hosted a conference call and webcast on August 5, 2025, at 8:00 a.m. ET, to review financial and operational results and provide business updates[5](index=5&type=chunk)[9](index=9&type=chunk) - An archived webcast is available on the Investor Relations section of Madrigal's website[9](index=9&type=chunk) - Investor Contact: Tina Ventura, IR@madrigalpharma.com[24](index=24&type=chunk) - Media Contact: Christopher Frates, media@madrigalpharma.com[24](index=24&type=chunk)

Bill Sibold, Chief Executive Officer of Madrigal, stated: "We've delivered another exceptional quarter driven by continued strong Rezdiffra demand. Additionally, we continued to execute on our strategy by securing a new U.S. patent extending Rezdiffra's patent protection to 2045; advancing our pipeline with an oral GLP-1 development candidate; preparing to enter Europe following a positive CHMP opinion; presenting compelling new two-year data in F4c; and strengthening our balance sheet with access to up to ...

临床前数据显示，SYH2086具有优异的体外激动活性和体内降糖、减重效果，并在不同动物种属上具有 宽剂量范围线性化的药物动力学(PK)行为，且无明显安全性风险。 （企业公告） 近日，石药集团发布与MADRIGAL就SYH2086订立独家授权协议的公告。披露集团已与Madrigal Pharmaceuticals, Inc.就本集团的口服小分子激活胰高血糖素样肽-1（"GLP-1"）受体激动剂SYH2086在 全球的开发、生产及商业化订立独家授权协议。 根据该协议的条款，本集团同意授予Madrigal在全球范围内开发、生产及商业化SYH2086的独家授权， 同时保留本集团在中国开发和销售其他口服小分子GLP-1受体激动剂产品的权益。本集团有权收取最高 可达20.75亿美元的总代价，包括1.2亿美元的预付款、最高可达19.55亿美元的潜在开发、监管及商业里 程碑付款，以及基于SYH2086年度淨销售额的高达双位数销售提成。 SYH2086是集团开发的具有完全自主知识产权的临床前候选药物，属于一种新型口服小分子GLP-1受体 激动剂。GLP-1受体激动剂是一类通过GLP-1受体发挥作用的药物，已被开发为用于2型糖尿 ...

Company Overview - Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) has been performing well in sales with its FDA-approved drug Rezdiffra (resmetirom), which is indicated for the treatment of adults with non-cirrhotic non-alcoholic fatty liver disease [2] Market Analysis - The Biotech Analysis Central service offers a comprehensive analysis of over 600 biotech investing articles and a model portfolio featuring more than 10 small and mid-cap stocks, providing in-depth analysis and live chat for healthcare investors [2]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準 確性或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部份內容而產生 或因倚賴該等內容而引致的任何損失承擔任何責任。 CSPC PHARMACEUTICAL GROUP LIMITED SYH2086是本集團開發的具有完全自主知識產權的臨床前候選藥物，屬於一種新型口服小 分子GLP -1受體激動劑。GLP -1受體激動劑是一類通過GLP -1受體發揮作用的藥物，已被開 發 為 用 於 2 型 糖 尿 病 和 肥 胖 症 管 理 的 治 療 方 法 ， 其 核 心 作 用 機 制 包 括 促 進 胰 島 素 分 泌 、 抑 制 胰 高 血 糖 素 釋 放 、 延 緩 胃 排 空 及 降 低 食 欲 ， 從 而 兼 具 降 糖 和 減 重 效 果 。 臨 床 前 數 據 顯 示，SYH2086具有優異的體外激動活性和體內降糖、減重效果，並在不同動物種屬上具有 寬劑量範圍線性化的藥物動力學(PK)行為，且無明顯安全性風險。 – 1 – 關於Madrigal Madrigal（ NASDAQ：MDGL ）是一家專注於提供代謝功能 ...

Core Insights - Madrigal Pharmaceuticals has entered into an exclusive global license agreement with CSPC Pharmaceutical Group for SYH2086, a preclinical oral GLP-1 receptor agonist, with plans to initiate clinical development in the first half of 2026 [1][2][3] Group 1: Company Developments - The agreement aligns with Madrigal's long-term goal to enhance its leadership in MASH by building a pipeline anchored by its existing product, Rezdiffra [2] - Madrigal's CEO highlighted the successful launch of Rezdiffra and the acquisition of new intellectual property protection through 2044 as part of their strategic priorities [2] - The combination of Rezdiffra and SYH2086 is expected to provide a best-in-class oral treatment for patients with MASH [2][6] Group 2: Financial Aspects - CSPC will receive an upfront payment of $120 million and may earn up to $2 billion in milestone payments based on the achievement of specific development, regulatory, and commercial milestones [3] - The transaction is expected to close in the fourth quarter of 2025, pending regulatory clearance [3] Group 3: Product Information - SYH2086 is a novel oral small molecule GLP-1 receptor agonist that has shown promising preclinical results, including glucose-lowering and weight-loss effects [4] - GLP-1 receptor agonists are designed to manage type 2 diabetes and obesity by enhancing insulin secretion and reducing appetite [4] Group 4: Industry Context - MASH is a serious liver disease that can lead to severe complications, including cirrhosis and liver cancer, and is a leading cause of liver transplantation [5][7] - The prevalence of MASH is expected to increase, highlighting the need for effective treatments [7]

Core Viewpoint - Madrigal Pharmaceuticals, Inc. is set to release its second-quarter 2025 financial results on August 5, 2025, before the U.S. financial markets open [1] 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 primary medication, Rezdiffra (resmetirom), is a once-daily oral THR-β agonist targeting the underlying causes of MASH and is the first FDA-approved treatment for MASH with moderate to advanced fibrosis [3] - An ongoing Phase 3 outcomes trial is assessing Rezdiffra for treating compensated MASH cirrhosis [3] Investor Relations - Following the financial results announcement, Madrigal's management will host a live webcast at 8 a.m. Eastern Time to discuss the financial and operational results [2] - The webcast will be accessible via the Investor Relations section of the Madrigal Pharmaceuticals website, with a recommendation for participants to register at least 15 minutes prior to the event [2]

CONSHOHOCKEN, Pa., July 22, 2025 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction- associated steatohepatitis (MASH), today announced that it has entered into a $500 million senior secured credit facility with funds managed by Blue Owl Capital (NYSE: OWL), a leading alternative asset manager, to primarily advance Madrigal's pipeline to further extend its leadership position in MASH. The non-dilut ...

Core Insights - Madrigal Pharmaceuticals (MDGL) shares increased by 10.9% following the U.S. Patent and Trademark Office's Notice of Allowance for a new patent related to the FDA-approved dosing regimen of its product Rezdiffra (resmetirom) [1][7] Company Developments - In 2024, the FDA granted accelerated approval to Rezdiffra, making it the first and only approved therapy for metabolic dysfunction-associated steatohepatitis (MASH) [2] - The new patent will protect Rezdiffra until September 30, 2044, and will be listed in the FDA's Orange Book, preventing generic competition and enhancing market exclusivity [3][7] - As of March 31, 2025, over 17,000 patients are currently receiving Rezdiffra treatment, indicating strong early demand [4][7] Clinical Pipeline - Madrigal Pharmaceuticals is awaiting a final decision on its regulatory filing for Rezdiffra for the MASH indication in the EU, expected in August [8] - 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 MASH [9] - A second phase III outcomes study (MAESTRO-NASH OUTCOMES) is evaluating the drug's effectiveness in patients with compensated MASH cirrhosis, with top-line data expected in 2027 [10] - The open-label extension of the MAESTRO-NAFLD-1 study shows that patients treated with Rezdiffra achieved significant reductions in liver damage over two years [11][12] Market Performance - Year-to-date, MDGL shares have gained 11.8%, outperforming the industry growth of 6.3% [6]

Company Overview - Madrigal (MDGL) shares increased by 10.9% to close at $344.97, with notable trading volume compared to typical sessions, and an overall gain of 11.3% over the past four weeks [1][2] Patent and Market Exclusivity - Madrigal received a Notice of Allowance for a new U.S. patent for Rezdiffra, its FDA-approved drug for noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), which is valid through 2044 and will enhance market exclusivity by blocking generics [2] Financial Performance Expectations - The company is expected to report a quarterly loss of $3.64 per share, reflecting a year-over-year increase of 48.7%, while revenues are projected to be $160.13 million, up 993.8% from the previous year [3] Earnings Estimate Trends - The consensus EPS estimate for Madrigal has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Comparison - Madrigal operates within the Zacks Medical - Drugs industry, where another company, Corcept Therapeutics (CORT), closed 2% higher at $72.85, with a return of -0.6% over the past month [4]