Madrigal Pharmaceuticals(MDGL) - 2025 Q1 - Quarterly Results

Executive Summary & Recent Corporate Updates Madrigal's CEO highlighted Rezdiffra's successful launch and market foundation, with strong Q1 2025 results and key clinical data CEO's Strategic Vision and Launch Success Madrigal's CEO highlighted the successful launch of Rezdiffra, the first FDA-approved MASH treatment, reaching over 17,000 patients and establishing a strong market foundation - Madrigal has executed an exceptional launch of Rezdiffra, the first FDA-approved treatment for MASH, reaching over 17,000 patients and building a strong foundation with healthcare providers and payers[3] - Rezdiffra is on track to become the foundational therapy across F2 to F4c MASH[3] - New Rezdiffra F4c late-breaking data from the MAESTRO-NAFLD-1 trial, showing its effect on the risk of clinically significant portal hypertension, will be shared at the EASL Congress[3] - A regulatory decision from the European Medicines Agency (EMA) for Rezdiffra is expected mid-year[3] Key Highlights of Q1 2025 and Recent Events The first quarter of 2025 saw significant achievements, including substantial net sales for Rezdiffra, continued patient adoption, and strong cash reserves, alongside key clinical data presentations and corporate appointments First-quarter 2025 Rezdiffra Net Sales and Patient Adoption | Metric | Value | | :-------------------------------- | :------------------- | | First-quarter 2025 Rezdiffra net sales | $137.3 million | | Patients on Rezdiffra (as of March 31, 2025) | >17,000 | | Cash, cash equivalents, restricted cash and marketable securities (as of March 31, 2025) | $848.1 million | - Two-year compensated MASH cirrhosis (F4c) data from the MAESTRO-NAFLD-1 trial was selected as an oral late-breaker at the EASL Congress (May 7-10)[5] - David Soergel, M.D., was appointed Chief Medical Officer, and Rebecca Taub, M.D., was named Senior Scientific and Medical Advisor[5] - Jacqualyn Fouse, Ph.D., was appointed to the Board of Directors[5] Clinical Development and Regulatory Updates Madrigal provided detailed two-year results from the MAESTRO-NAFLD-1 trial's F4c arm, demonstrating significant reductions in liver stiffness and a consistent safety profile for Rezdiffra - Two-year results from the active-treatment open-label compensated MASH cirrhosis (F4c) arm of the Phase 3 MAESTRO-NAFLD-1 trial (n=101) showed patients achieved a mean 6.7 kPa reduction in liver stiffness (VCTE), which was statistically significant from baseline[6][7] - 51% of F4c patients achieved a ≥ 25% reduction in liver stiffness, a magnitude associated with reduced progression to end-stage liver disease[7] - Rezdiffra's safety and tolerability profile in F4c patients was consistent with other clinical trials, with a low discontinuation rate due to adverse events[7] - Six Madrigal abstracts, including a late-breaking oral presentation on detailed two-year F4c data focusing on liver stiffness, fibrosis biomarkers, and the risk of clinically significant portal hypertension, were accepted for the EASL Congress (May 7-10, 2025)[7] - Madrigal will host an investor webcast on May 13, 2025, to review the detailed two-year F4c data[7] Corporate Governance and Leadership Changes Madrigal announced key leadership transitions, appointing a new Chief Medical Officer with extensive experience in metabolic and cardiovascular drug development, and adding an accomplished biotech executive to its Board of Directors - David Soergel, M.D., was appointed Chief Medical Officer in April, bringing over 20 years of leadership experience in metabolic and cardiovascular disease drug development[7] - Rebecca Taub, M.D., Madrigal's founder and former CMO, transitioned to Senior Scientific and Medical Advisor[7] - Jacqualyn Fouse, Ph.D., an accomplished biotech executive with over 30 years of biopharmaceutical and financial leadership experience, was appointed to Madrigal's Board of Directors in March 2025[7] First-Quarter 2025 Financial Results Madrigal reported $137.3 million Q1 2025 product revenue, with higher operating expenses from launch and reduced cash Revenue and Operating Expenses Madrigal reported its first product revenue of $137.3 million in Q1 2025, a significant increase from the prior year, with operating expenses rising due to commercial launch activities for Rezdiffra Three Months Ended March 31, 2025 vs 2024 (in thousands) | Metric | 2025 (in thousands) | 2024 (in thousands) | | :-------------------------------- | :------------------ | :------------------ | | Product revenue, net | $137,250 | $0 | | Cost of sales | $4,513 | $0 | | Research and development | $44,172 | $71,237 | | Selling, general and administrative | $167,876 | $80,800 | | Total operating expenses | $216,561 | $152,037 | | Loss from operations | $(79,311) | $(152,037) | | Interest income | $9,370 | $8,334 | | Interest expense | $(3,297) | $(3,838) | | Net loss | $(73,238) | $(147,541) | | Basic and diluted net loss per common share | $(3.32) | $(7.38) | - Research and development expenses decreased by $27.1 million year-over-year, primarily due to a change in accounting for inventory costs following FDA approval of Rezdiffra in March 2024 and a reduction in clinical trial expense[11] - Selling, general and administrative expenses increased by $87.1 million year-over-year, primarily due to increases for commercial launch activities for Rezdiffra, including a corresponding increase in headcount, and an increase in stock compensation expense[11] Balance Sheet Highlights Madrigal's cash, cash equivalents, restricted cash, and marketable securities decreased to $848.1 million as of March 31, 2025, primarily due to funding operations Balance Sheet Highlights (in thousands) | Metric | March 31, 2025 | December 31, 2024 | | :------------------------------------------------ | :------------- | :---------------- | | Cash, cash equivalents, restricted cash and marketable securities | $848,068 | $931,251 | | Total assets | $996,629 | $1,042,247 | | Current liabilities | $167,237 | $169,277 | | Long-term liabilities | $118,755 | $118,587 | | Stockholders' equity | $710,637 | $754,383 | | Total liabilities and stockholders' equity | $996,629 | $1,042,247 | - The decrease in cash, cash equivalents, restricted cash and marketable securities from $931.3 million at December 31, 2024, to $848.1 million at March 31, 2025, was attributable to funding of operations[11] Conference Call Details Madrigal hosted a conference call and webcast on May 1, 2025, to review its financial and operating results and provide a general business update - Madrigal hosted a webcast on May 1, 2025, at 8 a.m. EDT to review its financial and operating results and provide a general business update[9] - The webcast was accessible via the investor relations section of the Madrigal website, with an archived version available post-event[9] Disease Overview: MASH MASH is a severe liver disease progressing to life-threatening complications, with a significant patient population targeted by Madrigal Understanding MASH and its Progression Metabolic dysfunction-associated steatohepatitis (MASH) is a severe liver disease that can lead to life-threatening complications, including cirrhosis and liver failure, and is projected to become the leading cause of liver transplantation in the U.S - MASH (formerly NASH) is a serious liver disease that can progress to cirrhosis, liver failure, liver cancer, need for liver transplantation, and premature mortality[10] - MASH is expected to become the leading cause of liver transplantation in the U.S. and is already the leading cause among women[10] - Patients with moderate to advanced liver fibrosis (F2-F3) have a 10 to 17 times higher risk of liver-related mortality, while those who progress to cirrhosis (F4) face a 42 times higher risk[11][12] - MASH is also an independent driver of cardiovascular disease, the leading cause of mortality for patients[12] MASH Patient Population and Unmet Need An estimated 1.5 million patients are diagnosed with MASH in the U.S., with Madrigal specifically targeting approximately 315,000 patients with moderate to advanced fibrosis who are under the care of liver specialists - An estimated 1.5 million patients have been diagnosed with MASH in the U.S[13] - Madrigal is focused on reaching approximately 315,000 patients with moderate to advanced fibrosis who are under the care of liver specialists[13] - The number of diagnosed patients with MASH with moderate to advanced fibrosis is expected to grow as disease awareness and prevalence increase[13] Product Information: Rezdiffra Rezdiffra is an FDA-approved MASH treatment for moderate to advanced fibrosis, with critical safety information and potential side effects Rezdiffra Indication and Usage Rezdiffra is an FDA-approved prescription medicine, used in conjunction with diet and exercise, for adults with MASH and moderate to advanced liver scarring (fibrosis), excluding those with cirrhosis - Rezdiffra is a prescribed medicine used along with diet and exercise to treat adults with nonalcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver[14] - The indication is approved based on improvement of NASH and liver scarring (fibrosis), with ongoing studies to confirm the clinical benefit[14] - It is not known if Rezdiffra is safe and effective in children (under 18 years old)[14] Important Safety Information and Side Effects Patients considering Rezdiffra must inform their healthcare provider about existing medical conditions and all medications due to potential drug interactions and serious side effects, including liver injury and gallbladder problems - Patients should inform their healthcare provider about all medical conditions, including liver problems (other than NASH), gallbladder problems, pregnancy, and breastfeeding plans[15][17] - Patients must disclose all medicines, including prescription, over-the-counter, vitamins, and herbal supplements, especially gemfibrozil, cyclosporine (not recommended with Rezdiffra), clopidogrel, or statins[15][17] - Serious side effects include liver injury (hepatotoxicity) with symptoms like tiredness, nausea, vomiting, fever, rash, jaundice, or abdominal pain, and gallbladder problems (e.g., gallstones, inflammation) with symptoms like nausea, vomiting, fever, or severe abdominal pain[16][18] - The most common side effects of Rezdiffra include diarrhea, nausea, itching, stomach (abdominal) pain, vomiting, dizziness, and constipation[18] About Madrigal Pharmaceuticals Madrigal Pharmaceuticals develops MASH therapeutics, with Rezdiffra as its first FDA-approved medication for moderate to advanced fibrosis Company Overview and Product Focus Madrigal Pharmaceuticals is a biopharmaceutical company dedicated to developing novel therapeutics for MASH, a liver disease with high unmet medical need, with Rezdiffra as its flagship FDA-approved product - Madrigal Pharmaceuticals, Inc. is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH)[20] - Rezdiffra (resmetirom) is Madrigal's once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH[20] - Rezdiffra is the first and only medication approved by the FDA for the treatment of MASH with moderate to advanced fibrosis (consistent with stages F2 to F3)[20] - An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (consistent with stage F4c)[20] Forward-Looking Statements & Disclaimers Forward-looking statements are subject to risks and uncertainties, advising against undue reliance and directing readers to SEC filings Nature and Risks of Forward-Looking Statements This section clarifies that the press release contains forward-looking statements subject to various risks and uncertainties, including regulatory approvals, financial performance, clinical trial outcomes, market demand, and competitive factors - The press release includes "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995[21] - Forward-looking statements are subject to risks and uncertainties, including those related to obtaining and maintaining regulatory approvals, potential operating losses, meeting clinical trial objectives, market demand for Rezdiffra, capital raising, debt compliance, competitive trials, cyber-attacks, and changes in laws and regulations[21][22] - Undue reliance should not be placed on forward-looking statements, and Madrigal undertakes no obligation to update them[22] - Readers are directed to Madrigal's SEC filings (Form 10-K and 10-Q) for more detailed information regarding these risks and uncertainties[22] Financial Statements Madrigal's condensed consolidated statements of operations and balance sheets for Q1 2025 detail financial performance and position Condensed Consolidated Statements of Operations This statement provides a summary of Madrigal's financial performance for the three months ended March 31, 2025, compared to the same period in 2024, detailing revenues, operating expenses, and net loss Condensed Consolidated Statements of Operations (in thousands) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------------------------------ | :-------------------------------- | :-------------------------------- | | Product revenue, net | $137,250 | $0 | | Cost of sales | $4,513 | $0 | | Research and development | $44,172 | $71,237 | | Selling, general and administrative | $167,876 | $80,800 | | Total operating expenses | $216,561 | $152,037 | | Loss from operations | $(79,311) | $(152,037) | | Interest income | $9,370 | $8,334 | | Interest expense | $(3,297) | $(3,838) | | Net loss | $(73,238) | $(147,541) | | Basic and diluted net loss per common share | $(3.32) | $(7.38) | | Basic and diluted weighted average number of common shares outstanding | 22,061,214 | 20,001,560 | Condensed Consolidated Balance Sheets This statement presents Madrigal's financial position, including assets, liabilities, and equity, as of March 31, 2025, and December 31, 2024 Condensed Consolidated Balance Sheets (in thousands) | Metric | March 31, 2025 | December 31, 2024 | | :------------------------------------------------ | :------------- | :---------------- | | Cash, cash equivalents, restricted cash and marketable securities | $848,068 | $931,251 | | Trade receivables, net | $61,428 | $53,822 | | Other current assets | $78,483 | $47,854 | | Other non-current assets | $8,650 | $9,320 | | Total assets | $996,629 | $1,042,247 | | Current liabilities | $167,237 | $169,277 | | Long-term liabilities | $118,755 | $118,587 | | Stockholders' equity | $710,637 | $754,383 | | Total liabilities and stockholders' equity | $996,629 | $1,042,247 |