Madrigal Pharmaceuticals(MDGL) - 2025 Q2 - Quarterly Results

Madrigal Pharmaceuticals Q2 2025 Earnings Report Overview Q2 2025 Performance Highlights and Strategic Progress 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] - 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] 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 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][5][6] - 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][6] - Rezdiffra™ (resmetirom) net sales were $212.8 million in Q2 2025[5] - Over 23,000 patients were on Rezdiffra as of June 30, 2025[5] Pipeline Development & Financial Strengthening 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][6] - SYH2086 is expected to enter clinical trials in the first half of 2026[6] - Secured up to $500 million in senior secured credit to advance the MASH pipeline in a non-dilutive manner[5][6] - 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] Regulatory & Clinical Achievements 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][6] - These results further support the potential success of the ongoing MAESTRO-NASH OUTCOMES trial, with data expected in 2027[6] - 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] - 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][6] Corporate Governance Update 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][6] - Mr. Brennan previously served as Executive Vice President and Chief Financial Officer at Boston Scientific[6][7] Second-Quarter 2025 Financial Results Second-Quarter 2025 Financial Performance 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 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] - The decrease in R&D expenses is primarily due to reduced clinical trial costs[11] - The increase in SG&A expenses is primarily due to increased Rezdiffra commercial activities and personnel supporting commercialization[11] - The decrease in interest income is primarily due to lower cash balances[11] - The decrease in interest expense is primarily due to lower interest rates in 2025[11] Balance Sheet Overview 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] Disease and Product Information Understanding MASH 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] - 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] - MASH patients with moderate to advanced liver fibrosis (F2 to F3) have a 10- to 17-fold higher risk of liver-related mortality[11] - MASH patients who progress to cirrhosis (F4c) have a 42-fold higher risk of liver-related mortality[12] - 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] - The number of diagnosed F2 to F4c MASH patients is expected to grow with increasing disease awareness and prevalence[13] About Rezdiffra (resmetirom) 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] - Rezdiffra is the first and only FDA-approved medication for MASH with moderate to advanced fibrosis (F2 to F3 stage)[19] - Rezdiffra is a once-daily, oral, liver-targeted THR-β agonist designed to target the key underlying causes of MASH[19] Rezdiffra Indication and Usage 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] - This indication is approved based on improvement of NASH and liver scarring, with ongoing studies to confirm Rezdiffra's clinical benefit[14] - The safety and effectiveness of Rezdiffra in children (under 18 years of age) are not known[14] Important Safety Information and Side Effects 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][21] - If symptoms of hepatotoxicity (e.g., fatigue, nausea, vomiting, jaundice, abdominal pain) occur, stop taking Rezdiffra immediately and contact a healthcare provider[21] - The most common side effects include diarrhea, nausea, itching, stomach (abdominal) pain, vomiting, dizziness, and constipation[17] - 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] - 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][16] Additional Company Information About Madrigal Pharmaceuticals 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] - Rezdiffra (resmetirom) is a once-daily, oral, liver-targeted THR-β agonist designed to target the key underlying causes of MASH[19] - Rezdiffra is the first and only FDA-approved medication for MASH with moderate to advanced fibrosis (F2 to F3 stage)[19] - An ongoing Phase III outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c stage)[19] Forward-Looking Statements 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] - 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][22] - Madrigal undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances[22] - 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] Conference Call and Investor Relations 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][9] - An archived webcast is available on the Investor Relations section of Madrigal's website[9] - Investor Contact: Tina Ventura, IR@madrigalpharma.com[24] - Media Contact: Christopher Frates, media@madrigalpharma.com[24]