Group 1 - Madrigal reported a quarterly loss of $3.32 per share, better than the Zacks Consensus Estimate of a loss of $3.62, and an improvement from a loss of $7.38 per share a year ago, representing an earnings surprise of 8.29% [1] - The company posted revenues of $137.25 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 20.35%, compared to zero revenues a year ago [2] - Madrigal shares have increased approximately 8.2% since the beginning of the year, while the S&P 500 has declined by 5.3% [3] Group 2 - The current consensus EPS estimate for the coming quarter is -$3.31 on revenues of $137.59 million, and -$12.43 on revenues of $576.53 million for the current fiscal year [7] - The Zacks Industry Rank for Medical - Drugs is currently in the top 23% of over 250 Zacks industries, indicating a favorable outlook for the industry [8] Group 3 - The estimate revisions trend for Madrigal is mixed, resulting in a Zacks Rank 3 (Hold) for the stock, suggesting it is expected to perform in line with the market in the near future [6] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Performance - For the three months ended March 31, 2025, the company recorded $137.3 million in product revenue, net, representing a 100% increase compared to the previous year[134]. - The cost of sales for the same period was $4.5 million, also reflecting a 100% increase due to the sales of Rezdiffra[135]. - Selling, general and administrative expenses increased by 108% to $167.9 million compared to $80.8 million in the previous year[133]. - The total operating expenses for the three months ended March 31, 2025, were $216.6 million, a 42% increase from $152.0 million in the same period last year[133]. - The net loss for the quarter was $73.2 million, a 50% improvement from a net loss of $147.5 million in the prior year[133]. Research and Development - Research and development expenses decreased by 38% to $44.2 million from $71.2 million in the prior year[133]. - Research and development expenses decreased to $44.2 million for the three months ended March 31, 2025, down 38% from $71.2 million in 2024[136]. - The company intends to selectively in-license or acquire rights to programs at all stages of development to diversify its portfolio and enhance its drug development capabilities[118]. Product Approval and Market Potential - The FDA approved Rezdiffra in March 2024, making it the first therapy for patients with MASH, and it became commercially available in April 2024[112]. - The company estimates approximately 1.5 million patients in the U.S. have been diagnosed with MASH, with about 525,000 having moderate to advanced fibrosis[115]. - The company plans to commercialize Rezdiffra in Europe, with a regulatory decision expected in mid-2025 and a potential launch starting in Germany in the second half of 2025[117]. Cash Flow and Financing - Cash, cash equivalents, restricted cash, and marketable securities totaled $848.1 million as of March 31, 2025, down from $931.3 million at the end of 2024, reflecting funding of operations[141]. - Net cash used in operating activities was $88.9 million in Q1 2025, a decrease of 40.3% from $149.2 million in Q1 2024[155]. - Net cash provided by investing activities was $163.9 million in Q1 2025, compared to $98.1 million in Q1 2024, primarily from sales and maturities of marketable securities[156]. - Net cash provided by financing activities was $8.6 million in Q1 2025, a significant drop from $573.7 million in Q1 2024, which included proceeds from a public offering[157]. - As of March 31, 2025, the outstanding principal under the Loan Facility was $115.0 million, with an interest rate of 9.95%[149]. - As of March 31, 2025, the company had drawn $115.0 million under the $250.0 million Loan Facility[160]. Future Outlook and Risks - The company anticipates continued significant losses until sufficient revenue is generated from Rezdiffra and other future products[142]. - The company has the ability to delay certain commercial and research activities due to liquidity concerns until those concerns are alleviated[142]. - There have been no material changes to market risks since December 31, 2024, and no near-term changes are anticipated[164]. - No significant changes to contractual obligations and commitments occurred during the three months ended March 31, 2025, compared to the previous fiscal year[163]. - The company received FDA approval for Rezdiffra in March 2024, with a tiered single-digit royalty payable to Roche on net sales[161]. - The company had approximately $89.1 million of obligations under agreements related to active pharmaceutical ingredients, expected to be paid through December 2027[162].

Financial Data and Key Metrics Changes - For Q1 2025, net sales totaled $137.3 million, representing a 33% increase from Q4 2024 [30] - Over the last twelve months, the company generated $317 million in net sales, indicating strong demand and momentum [28][30] - R&D expenses decreased to $44.2 million in Q1 2025 from $71.2 million in Q1 2024, primarily due to changes in accounting for inventory costs and lower clinical trial costs [31] - SG&A expenses increased to $167.9 million in Q1 2025 from $80.8 million in Q1 2024, driven by increased commercial launch activities [32] Business Line Data and Key Metrics Changes - The company has treated over 17,000 patients with ResDiffera, up from 11,800 patients at the end of Q4 2024, indicating strong patient adoption [12] - Approximately 70% of the top 6,000 target prescribers have prescribed ResDiffera, reflecting a strong base of prescribers [15] - The company is focused on a target market of 315,000 diagnosed F2 and F3 MAH patients, with only about 5% currently being treated with ResDiffera [13] Market Data and Key Metrics Changes - The company is preparing for a mid-year regulatory decision in Europe, with plans to launch in Germany in the second half of the year if approved [26] - The company is evaluating additional high-priority global markets beyond Europe [26] Company Strategy and Development Direction - The expansion to treat F4C patients is a key pillar of the company's long-term NASH leadership strategy, with ongoing trials expected to yield data ahead of competitors [25] - The company aims to build a portfolio of differentiated assets to extend its leadership position in the market [27][90] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's positioning within the current macroeconomic environment, highlighting the strong cash position to support ongoing launches [29] - The company expects robust year-over-year net sales growth in 2025, despite anticipated increases in gross-to-net discounts as payer contracts are established [30][31] Other Important Information - The company has recently appointed a new Chief Medical Officer, Dave Sorgel, to lead pipeline development efforts [9][27] - The company is actively evaluating opportunities across multiple mechanisms and stages of development to enhance its product offerings [27] Q&A Session Summary Question: Expectations for growth trajectory for ResDiffera with expanded label - Management expects continued growth in patient numbers and market expansion, with significant potential for new patient additions as the market evolves [39][40] Question: Payer reauthorization requirements and patient persistency - Management is not concerned about reauthorizations, citing strong results and patient feedback, which should support persistency [45][47] Question: Status of European approval and implications for pricing - Management is optimistic about the ongoing review process in Europe and expects to launch later this year, with pricing strategies being evaluated [53][56] Question: Confidence in outcomes benefit on hepatic events - Management expressed confidence in the liver stiffness data translating to clinical outcomes, supported by the mechanism of action of ResDiffera [62] Question: Compliance rates and patient feedback on therapy - Early signs of adherence are promising, with anecdotal evidence suggesting patients feel better on the therapy [66][69] Question: Insights on gross-to-net pricing evolution - Management anticipates a disciplined approach to gross-to-net pricing, with ongoing discussions with payers [106][108]

Financial Data and Key Metrics Changes - For Q1 2025, net sales totaled $137.3 million, representing a 33% increase from Q4 2024 [29][30] - R&D expenses decreased to $44.2 million from $71.2 million in Q1 2024, primarily due to changes in accounting for inventory costs and lower clinical trial costs [30] - SG&A expenses increased to $167.9 million from $80.8 million in Q1 2024, driven by increased commercial launch activities for Risdifa [31] Business Line Data and Key Metrics Changes - Risdifa generated $317 million in net sales over its first twelve months on the market, with Q1 2025 net sales of $137 million [8][29] - The number of patients on Risdifa increased to over 17,000 by the end of Q1 2025, up from 11,800 at the end of Q4 2024 [10][11] - Approximately 70% of the top 6,000 target prescribers have prescribed Risdifa, indicating strong physician adoption [13][15] Market Data and Key Metrics Changes - The target market consists of 315,000 diagnosed F2 and F3 MAH patients, with only about 5% currently being treated with Risdifa [11][12] - The company is focused on expanding its market presence, with plans to launch in Europe in the second half of 2025 [24] Company Strategy and Development Direction - The company aims to expand Risdifa's indication to F4C patients, which could potentially double its market opportunity [23] - Madrigal is also preparing for a mid-year regulatory decision in Europe and evaluating additional global markets [24][25] - The company is looking to build a pipeline of differentiated assets to extend its leadership position in NASH [25][88] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing demand for Risdifa and the company's strong positioning in the current macroeconomic environment [28] - The management team anticipates robust year-over-year net sales growth in 2025, despite expected increases in gross-to-net discounts as payer contracts are established [29][30] Other Important Information - The company has transitioned from an R&D-focused organization to a fully integrated commercial stage company following the approval of Risdifa [6] - The management highlighted the importance of patient education and awareness in driving treatment adoption [84] Q&A Session Summary Question: Expectations for growth trajectory for Risdifa with expanded label - Management expects continued growth and believes the market will expand significantly with the potential approval of SEMA [36][39] Question: Payer reauthorization requirements and patient persistency - Management is not concerned about reauthorizations and expects good persistency due to positive feedback from physicians and patients [42][45] Question: Status of European approval and launch strategy - The company is on track for a mid-year regulatory decision in Europe and is optimistic about the approval process [48][50] Question: Confidence in outcomes benefit on hepatic events - Management expressed confidence in the liver stiffness data and its relevance to patient outcomes [57][60] Question: Compliance rate and patient feedback on therapy - Early signs of adherence are promising, with patients reporting positive experiences on the drug [63][65] Question: Insights on gross-to-net pricing and payer discussions - Management is disciplined about gross-to-net pricing and anticipates it will evolve as payer contracts are established [68][106] Question: Feedback on DTC campaign and business development strategy - Positive feedback on the DTC campaign has been received, and the company is focused on building a pipeline to sustain its leadership position [82][87]

[Executive Summary & Recent Corporate Updates](index=1&type=section&id=Executive%20Summary%20%26%20Recent%20Corporate%20Updates) 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](index=1&type=section&id=CEO%27s%20Strategic%20Vision%20and%20Launch%20Success) 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](index=3&type=chunk) - Rezdiffra is on track to become the foundational therapy across F2 to F4c MASH[3](index=3&type=chunk) - 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](index=3&type=chunk) - A regulatory decision from the European Medicines Agency (EMA) for Rezdiffra is expected mid-year[3](index=3&type=chunk) [Key Highlights of Q1 2025 and Recent Events](index=1&type=section&id=Key%20Highlights%20of%20Q1%202025%20and%20Recent%20Events) 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](index=5&type=chunk) - David Soergel, M.D., was appointed Chief Medical Officer, and Rebecca Taub, M.D., was named Senior Scientific and Medical Advisor[5](index=5&type=chunk) - Jacqualyn Fouse, Ph.D., was appointed to the Board of Directors[5](index=5&type=chunk) [Clinical Development and Regulatory Updates](index=1&type=section&id=Clinical%20Development%20and%20Regulatory%20Updates) 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](index=6&type=chunk)[7](index=7&type=chunk) - **51% of F4c patients** achieved a ≥ 25% reduction in liver stiffness, a magnitude associated with reduced progression to end-stage liver disease[7](index=7&type=chunk) - 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](index=7&type=chunk) - 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](index=7&type=chunk) - Madrigal will host an investor webcast on May 13, 2025, to review the detailed two-year F4c data[7](index=7&type=chunk) [Corporate Governance and Leadership Changes](index=2&type=section&id=Corporate%20Governance%20and%20Leadership%20Changes) 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](index=7&type=chunk) - Rebecca Taub, M.D., Madrigal's founder and former CMO, transitioned to Senior Scientific and Medical Advisor[7](index=7&type=chunk) - 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](index=7&type=chunk) [First-Quarter 2025 Financial Results](index=3&type=section&id=First-Quarter%202025%20Financial%20Results) Madrigal reported $137.3 million Q1 2025 product revenue, with higher operating expenses from launch and reduced cash [Revenue and Operating Expenses](index=3&type=section&id=Revenue%20and%20Operating%20Expenses) 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](index=11&type=chunk) - 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](index=11&type=chunk) [Balance Sheet Highlights](index=3&type=section&id=Balance%20Sheet%20Highlights) 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](index=11&type=chunk) [Conference Call Details](index=3&type=section&id=Conference%20Call%20Details) 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](index=9&type=chunk) - The webcast was accessible via the investor relations section of the Madrigal website, with an archived version available post-event[9](index=9&type=chunk) [Disease Overview: MASH](index=3&type=section&id=Disease%20Overview%3A%20MASH) MASH is a severe liver disease progressing to life-threatening complications, with a significant patient population targeted by Madrigal [Understanding MASH and its Progression](index=3&type=section&id=Understanding%20MASH%20and%20its%20Progression) 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](index=10&type=chunk) - MASH is expected to become the leading cause of liver transplantation in the U.S. and is already the leading cause among women[10](index=10&type=chunk) - 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](index=11&type=chunk)[12](index=12&type=chunk) - MASH is also an independent driver of cardiovascular disease, the leading cause of mortality for patients[12](index=12&type=chunk) [MASH Patient Population and Unmet Need](index=4&type=section&id=MASH%20Patient%20Population%20and%20Unmet%20Need) 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](index=13&type=chunk) - Madrigal is focused on reaching approximately **315,000 patients** with moderate to advanced fibrosis who are under the care of liver specialists[13](index=13&type=chunk) - The number of diagnosed patients with MASH with moderate to advanced fibrosis is expected to grow as disease awareness and prevalence increase[13](index=13&type=chunk) [Product Information: Rezdiffra](index=4&type=section&id=Product%20Information%3A%20Rezdiffra) Rezdiffra is an FDA-approved MASH treatment for moderate to advanced fibrosis, with critical safety information and potential side effects [Rezdiffra Indication and Usage](index=4&type=section&id=Rezdiffra%20Indication%20and%20Usage) 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](index=14&type=chunk) - The indication is approved based on improvement of NASH and liver scarring (fibrosis), with ongoing studies to confirm the clinical benefit[14](index=14&type=chunk) - It is not known if Rezdiffra is safe and effective in children (under 18 years old)[14](index=14&type=chunk) [Important Safety Information and Side Effects](index=4&type=section&id=Important%20Safety%20Information%20and%20Side%20Effects) 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](index=15&type=chunk)[17](index=17&type=chunk) - 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](index=15&type=chunk)[17](index=17&type=chunk) - 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](index=16&type=chunk)[18](index=18&type=chunk) - The most common side effects of Rezdiffra include diarrhea, nausea, itching, stomach (abdominal) pain, vomiting, dizziness, and constipation[18](index=18&type=chunk) [About Madrigal Pharmaceuticals](index=5&type=section&id=About%20Madrigal%20Pharmaceuticals) Madrigal Pharmaceuticals develops MASH therapeutics, with Rezdiffra as its first FDA-approved medication for moderate to advanced fibrosis [Company Overview and Product Focus](index=5&type=section&id=Company%20Overview%20and%20Product%20Focus) 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](index=20&type=chunk) - Rezdiffra (resmetirom) is Madrigal's once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH[20](index=20&type=chunk) - 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](index=20&type=chunk) - An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (consistent with stage F4c)[20](index=20&type=chunk) [Forward-Looking Statements & Disclaimers](index=5&type=section&id=Forward-Looking%20Statements%20%26%20Disclaimers) 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](index=5&type=section&id=Nature%20and%20Risks%20of%20Forward-Looking%20Statements) 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](index=21&type=chunk) - 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](index=21&type=chunk)[22](index=22&type=chunk) - Undue reliance should not be placed on forward-looking statements, and Madrigal undertakes no obligation to update them[22](index=22&type=chunk) - Readers are directed to Madrigal's SEC filings (Form 10-K and 10-Q) for more detailed information regarding these risks and uncertainties[22](index=22&type=chunk) [Financial Statements](index=7&type=section&id=Financial%20Statements) Madrigal's condensed consolidated statements of operations and balance sheets for Q1 2025 detail financial performance and position [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) 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](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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 |

Core Viewpoint - Madrigal Pharmaceuticals has successfully launched Rezdiffra, the first FDA-approved treatment for metabolic dysfunction-associated steatohepatitis (MASH), achieving significant patient engagement and positive feedback from healthcare providers [2][4]. Financial Results - First-quarter 2025 net sales for Rezdiffra reached $137.3 million, with over 17,000 patients treated as of March 31, 2025 [4][21]. - Operating expenses for the first quarter of 2025 were $216.6 million, compared to $152.0 million in the same period last year [21]. - Research and development expenses decreased to $44.2 million from $71.2 million year-over-year, primarily due to changes in accounting for inventory costs and reduced clinical trial expenses [21]. - Selling, general and administrative expenses increased to $167.9 million from $80.8 million, driven by commercial launch activities for Rezdiffra [21]. - The company reported a net loss of $73.2 million for the first quarter of 2025, compared to a net loss of $147.5 million in the prior year [21]. Corporate Updates - Madrigal appointed David Soergel, M.D., as Chief Medical Officer and Rebecca Taub, M.D., as Senior Scientific and Medical Advisor [4][9]. - The company has a strong presence at the upcoming EASL Congress, with six abstracts accepted, including late-breaking data from the MAESTRO-NAFLD-1 trial [5][4]. - Madrigal's cash, cash equivalents, restricted cash, and marketable securities totaled $848.1 million as of March 31, 2025, down from $931.3 million at the end of 2024 [21][23]. Product and Market Insights - Rezdiffra is designed to treat adults with MASH with moderate to advanced liver scarring and is the first medication approved for this indication [12][17]. - The company aims to reach approximately 315,000 patients with moderate to advanced fibrosis under the care of liver specialists in the U.S. [11]. - The MAESTRO-NAFLD-1 trial data indicates a mean reduction of 6.7 kPa in liver stiffness, with 51% of patients achieving a ≥ 25% reduction, which is associated with reduced progression to end-stage liver disease [5][4].

Core Insights - Madrigal Pharmaceuticals is set to present significant data on resmetirom at the EASL Congress, highlighting its potential to improve liver health in patients with compensated MASH cirrhosis [1][3] - The company is preparing for a European Commission decision regarding the marketing authorization application for resmetirom, with expectations to launch in Germany in the second half of 2025 [2] Company Overview - Madrigal Pharmaceuticals focuses on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease with high unmet medical need [14] - Resmetirom is the first approved medication for MASH in the U.S., targeting key underlying causes of the disease [1][14] Clinical Data and Presentations - The late-breaking oral presentation at EASL will detail two-year data from the Phase 3 MAESTRO-NAFLD-1 trial, showing improvements in liver stiffness and fibrosis biomarkers in 122 patients [1][3] - Additional posters will cover various aspects of MASH, including baseline characteristics and the use of noninvasive tests for diagnosis [3] Market Context - An estimated 1.5 million patients in the U.S. have been diagnosed with MASH, with a focus on reaching approximately 315,000 patients with moderate to advanced fibrosis [7] - MASH is projected to become the leading cause of liver transplantation in the U.S., emphasizing the urgency for effective treatments [5][6]

Core Viewpoint - Madrigal Pharmaceuticals is set to release its first-quarter 2025 financial results on May 1, 2025, before the U.S. markets open [1] Company Overview - Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) 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 (F2 to F3 stages) [3] - An ongoing Phase 3 trial is assessing Rezdiffra for treating compensated MASH cirrhosis (F4c stage) [3] Upcoming Events - 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 in advance [2]

CONSHOHOCKEN, Pa., April 16, 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 Rebecca Taub, M.D., the company's founder, Chief Medical Officer, and President of Research & Development (R&D), will transition to the role of Senior Scientific and Medical Advisor. Dr. Taub will continue to serve on Madrigal's Board of Directors. Succeeding ...

Company Overview - Madrigal Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) [5] - The company's medication, Rezdiffra (resmetirom), is the first and only FDA-approved treatment for MASH with moderate to advanced fibrosis [6] Leadership Transition - Rebecca Taub, M.D., the founder and Chief Medical Officer, will transition to Senior Scientific and Medical Advisor while continuing on the Board of Directors [1] - David Soergel, M.D., has been appointed as the new Executive Vice President and Chief Medical Officer, effective April 21, 2025 [1] Achievements and Future Plans - Under Dr. Taub's leadership, Madrigal achieved the milestone of developing Rezdiffra, the first FDA-approved medicine for MASH, providing hope to patients [2][3] - Dr. Soergel brings over 20 years of experience in drug development for metabolic and cardiovascular diseases, which aligns with the company's goal to expand its pipeline beyond Rezdiffra [3][4] Company Growth - Madrigal has grown from a small team of fewer than 10 R&D professionals to a commercial-stage biopharma company with over 500 employees across the U.S. and Europe [3]