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].

Core Insights - The article discusses the trading strategies around biotech stocks, particularly focusing on events such as trial results and NDA/BLA approvals [1] - It emphasizes the importance of understanding FDA regulations in the biotech industry [1] Group 1: Trading Strategies - The focus is on trading biotech stocks based on significant events that can impact stock prices, such as trial results and regulatory approvals [1] - The article suggests that these events create opportunities for traders to capitalize on price movements [1] Group 2: Industry Regulations - The biotech industry is heavily regulated by the FDA, which plays a crucial role in the approval process for new drugs and therapies [1] - Understanding the regulatory landscape is essential for making informed investment decisions in this sector [1]

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.

Company Overview - Madrigal Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with significant unmet medical needs [2] - The company's medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist targeting key underlying causes of MASH [2] - Rezdiffra is the first and only medication approved by the FDA for treating MASH with moderate to advanced fibrosis, specifically stages F2 to F3 [2] - An ongoing Phase 3 outcomes trial is assessing Rezdiffra for the treatment of compensated MASH cirrhosis, corresponding to stage F4c [2] Upcoming Events - Madrigal Pharmaceuticals will participate in the Canaccord Genuity 45 Annual Growth Conference on August 12, 2025, at 10:30 A.M. EDT [1] - The presentation will be available via a live webcast, with a replay accessible after the event [1]

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]

[FORM 10-Q Filing Information](index=1&type=section&id=FORM%2010-Q) This section presents essential Form 10-Q filing information, covering the reporting period, company specifics, and outstanding common stock - This is a Quarterly Report on Form 10-Q for the period ended **June 30, 2025**[2](index=2&type=chunk) - Madrigal Pharmaceuticals, Inc. is incorporated in Delaware with Commission file number **001-33277**[2](index=2&type=chunk) - As of August 1, 2025, the registrant had **22,289,014 shares of common stock outstanding**[6](index=6&type=chunk) [Cautionary Note Regarding Forward-Looking Statements](index=4&type=section&id=CAUTIONARY%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section outlines risks and uncertainties in forward-looking statements, which may cause actual results to differ materially - The report contains forward-looking statements subject to risks and uncertainties that may cause actual results to differ materially from current expectations[9](index=9&type=chunk)[10](index=10&type=chunk) - Key forward-looking statements relate to the successful commercialization and regulatory approval of Rezdiffra in the U.S. and Europe, market acceptance, reimbursement, and potential expansion of its indication[11](index=11&type=chunk) - Other forward-looking statements cover business strategies, clinical trial timing, manufacturing capabilities, future financial performance, liquidity, and the impact of healthcare industry regulation and economic conditions[11](index=11&type=chunk) [Part I. Financial Information](index=6&type=section&id=Part%20I.%2E%20Financial%20Information) This part presents the company's unaudited financial statements and management's discussion of financial condition [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, comprehensive loss, stockholders' equity, cash flows, and detailed notes explaining the company's financial position and performance [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20at%20June%2030%2C%202025%20and%20December%2031%2C%202024) This table presents the company's financial position, detailing assets, liabilities, and equity at specific dates Condensed Consolidated Balance Sheets (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Total assets | $1,015,381 | $1,042,247 | | Total liabilities | $319,403 | $287,864 | | Total stockholders' equity | $695,978 | $754,383 | - Total assets **decreased by $26.9 million** from December 31, 2024, to June 30, 2025, while total liabilities **increased by $31.5 million**[15](index=15&type=chunk) - Cash and cash equivalents **increased from $100.0 million to $186.2 million**, while marketable securities **decreased from $826.2 million to $610.8 million**[15](index=15&type=chunk) [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) This table summarizes the company's financial performance, including revenue, expenses, and net loss over specified periods Condensed Consolidated Statements of Operations (in thousands) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Product revenue, net | $212,802 | $14,638 | $350,052 | $14,638 | | Total operating expenses | $260,004 | $177,175 | $476,565 | $329,213 | | Loss from operations | $(47,202) | $(162,537) | $(126,513) | $(314,575) | | Net loss | $(42,281) | $(151,971) | $(115,519) | $(299,512) | | Basic and diluted net loss per common share | $(1.90) | $(7.10) | $(5.22) | $(14.47) | - Product revenue, net, significantly increased for both the three-month (**1354% YoY**) and six-month (**2291% YoY**) periods ended June 30, 2025, driven by Rezdiffra sales[17](index=17&type=chunk) - Net loss substantially decreased for both periods, from **$(152.0) million to $(42.3) million** for the three months, and from **$(299.5) million to $(115.5) million** for the six months ended June 30, 2025[17](index=17&type=chunk) [Condensed Consolidated Statements of Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) This table details the company's comprehensive loss, including net loss and other comprehensive income or loss Condensed Consolidated Statements of Comprehensive Loss (in thousands) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(42,281) | $(151,971) | $(115,519) | $(299,512) | | Other comprehensive income (loss): | | | | | | Unrealized loss on available-for-sale securities | $(188) | $(196) | $(299) | $(836) | | Unrealized foreign currency gain | $910 | — | $942 | — | | Comprehensive loss | $(41,559) | $(152,167) | $(114,876) | $(300,348) | - Comprehensive loss **decreased significantly**, mirroring the reduction in net loss, with a **positive contribution from unrealized foreign currency gain in 2025**[19](index=19&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) This table outlines changes in stockholders' equity, reflecting net loss, stock-based compensation, and equity issuances Condensed Consolidated Statements of Stockholders' Equity (in thousands) | Item | December 31, 2024 | June 30, 2025 | | :-------------------------------- | :---------------- | :------------ | | Total stockholders' equity | $754,383 | $695,978 | | Additional paid-in capital | $2,556,095 | $2,612,566 | | Accumulated deficit | $(1,802,182) | $(1,917,701) | - Total stockholders' equity **decreased by $58.4 million** from December 31, 2024, to June 30, 2025, primarily due to the **net loss of $(115.5) million**[21](index=21&type=chunk) - Additional paid-in capital **increased by $56.5 million**, driven by stock-based compensation expense and common stock issuances under equity plans[21](index=21&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) This table presents the company's cash flows from operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows (in thousands) | Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(135,943) | $(284,102) | | Net cash provided by (used in) investing activities | $211,736 | $(24,045) | | Net cash provided by financing activities | $10,381 | $707,829 | | Net increase in cash, cash equivalents, and restricted cash | $86,174 | $399,682 | | Cash, cash equivalents, and restricted cash at end of period | $191,193 | $499,597 | - Net cash used in operating activities **decreased by $148.2 million**, reflecting improved operational cash flow[25](index=25&type=chunk) - Investing activities shifted from a **net cash outflow of $24.0 million in 2024 to a net cash inflow of $211.7 million in 2025**, primarily due to sales and maturities of marketable securities[25](index=25&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures for the condensed consolidated financial statements, covering significant accounting policies, liquidity, revenue recognition, debt, equity, and subsequent events [Organization, Business, and Basis of Presentation](index=12&type=section&id=1.%20Organization%2C%20Business%2C%20and%20Basis%20of%20Presentation) Madrigal Pharmaceuticals is a biopharmaceutical company focused on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) - Madrigal Pharmaceuticals is a biopharmaceutical company focused on developing novel therapeutics for **metabolic dysfunction-associated steatohepatitis (MASH)**[27](index=27&type=chunk) - Rezdiffra (resmetirom) received **FDA accelerated approval in March 2024** as the first and only therapy for MASH, commercially available in the U.S. since April 2024[27](index=27&type=chunk) - The company is evaluating Rezdiffra in patients with compensated MASH cirrhosis (F4c) in the MAESTRO MASH OUTCOMES trial to potentially expand its eligible patient population[27](index=27&type=chunk) [Summary of Significant Accounting Policies](index=12&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This section outlines the key accounting principles and policies applied in preparing the financial statements - Revenue from product sales is recognized when the customer obtains control of the product, typically upon delivery, and is recorded net of variable consideration such as discounts, returns, chargebacks, rebates, and co-payment assistance[33](index=33&type=chunk)[34](index=34&type=chunk) - Inventory costs are capitalized after **FDA approval of Rezdiffra in March 2024**; prior manufacturing costs were expensed as research and development[53](index=53&type=chunk) - Research and development costs are expensed as incurred, including internal costs, consultant fees, milestone payments, and costs associated with preclinical and clinical programs[54](index=54&type=chunk) - The company adopted ASU 2023-07 (Segment Reporting) for its 2024 Annual Report and is evaluating the impact of ASU 2024-03 (Disaggregation of Income Statement Expenses)[68](index=68&type=chunk)[70](index=70&type=chunk) [Liquidity and Uncertainties](index=17&type=section&id=3.%20Liquidity%20and%20Uncertainties) This section discusses the company's financial liquidity, funding sources, and ability to meet future operational needs - The company incurred a **net loss of approximately $115.5 million** for the six months ended June 30, 2025, resulting in an **accumulated deficit of approximately $1,917.7 million**[72](index=72&type=chunk) - Operations have been funded primarily through capital stock sales, debt financings, and since April 2024, sales of Rezdiffra[72](index=72&type=chunk) - Management believes its cash, cash equivalents, and marketable securities at June 30, 2025, will be sufficient to fund operations past one year from the issuance of these financial statements[72](index=72&type=chunk) [Product Revenue, Net](index=18&type=section&id=4.%2E%20Product%20Revenue%2C%20Net) This section details the company's product revenue, net of various deductions, and identifies key customers Gross to Net Reserves (in thousands) | Item | December 31, 2024 | June 30, 2025 | | :-------------------------------- | :---------------- | :------------ | | Balance at period end | $25,891 | $52,343 | | Provision related to sales in current year | — | $82,446 | | Payments and customer credits issued | — | $(52,902) | - Gross to net reserves **increased from $25.9 million at December 31, 2024, to $52.3 million at June 30, 2025**[74](index=74&type=chunk) - Four customers (A, B, C, D) each accounted for **over 10% of total gross product revenue** during the three and six months ended June 30, 2025 and 2024[76](index=76&type=chunk) [Cash, Cash Equivalents, Restricted Cash and Marketable Securities](index=19&type=section&id=5.%20Cash%2C%20Cash%20Equivalents%2C%20Restricted%20Cash%20and%20Marketable%20Securities) This section provides a breakdown of the company's cash, cash equivalents, restricted cash, and marketable securities Cash, Cash Equivalents, Restricted Cash and Marketable Securities (in thousands) | Item | June 30, 2025 (Fair Value) | December 31, 2024 (Fair Value) | | :-------------------------------- | :------------------------- | :----------------------------- | | Total cash, cash equivalents and restricted cash | $191,193 | $105,019 | | Marketable securities | $610,831 | $826,232 | | Total | $802,024 | $931,251 | - Restricted cash remained constant at **$5.0 million** as of June 30, 2025, and December 31, 2024[77](index=77&type=chunk) - The majority of financial assets are valued using **Level 1 (quoted prices in active markets) and Level 2 (observable inputs other than Level 1) inputs**[50](index=50&type=chunk) [Inventory](index=20&type=section&id=6.%20Inventory) This section details the company's inventory balances, including work in process and finished goods Inventory Balances (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Work in process | $57,911 | $29,533 | | Finished goods | $5,586 | $4,535 | | Total inventory | $63,497 | $34,068 | - Total inventory **increased by $29.4 million** from December 31, 2024, to June 30, 2025[78](index=78&type=chunk) - No provision for excess inventory was recorded as of June 30, 2025, or December 31, 2024[78](index=78&type=chunk) [Accrued Liabilities](index=20&type=section&id=7.%20Accrued%20Liabilities) This section provides a breakdown of the company's accrued liabilities, including contract research organization and manufacturing costs Accrued Liabilities (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Contract research organization costs | $32,796 | $30,250 | | Manufacturing and drug supply | $25,798 | $9,941 | | Compensation and benefits | $27,691 | $34,957 | | Gross to net accrued liabilities | $48,062 | $21,703 | | Total accrued liabilities | $157,479 | $124,695 | - Total accrued liabilities **increased by $32.8 million** from December 31, 2024, to June 30, 2025[79](index=79&type=chunk) - The increase was primarily driven by **higher gross to net accrued liabilities and manufacturing and drug supply costs**[79](index=79&type=chunk) [Long Term Debt](index=20&type=section&id=8.%20Long%20Term%20Debt) This section details the company's long-term debt obligations, including recent financing and repayment activities - The Hercules Loan Facility, with an outstanding principal of **$115.0 million** as of June 30, 2025, was fully repaid and terminated on July 17, 2025, totaling **$121.7 million** including accrued interest and exit fees[86](index=86&type=chunk)[87](index=87&type=chunk) - On July 17, 2025, the company entered into a new Financing Agreement (Blue Owl Credit Facility) providing up to **$500.0 million** in senior secured credit facilities, including an initial **$350.0 million** term loan[90](index=90&type=chunk) - The new credit facility bears interest at **three-month SOFR (with a 1.0% floor) plus 4.75%** and matures on **July 17, 2030**, requiring a minimum unrestricted cash balance of **$100.0 million**[91](index=91&type=chunk)[93](index=93&type=chunk) [Stockholders' Equity](index=23&type=section&id=9.%20Stockholders%27%20Equity) This section describes changes in stockholders' equity, including public offerings and equity compensation plans - In March 2024, the company completed a public offering, raising approximately **$659.9 million in net proceeds**, including the exercise of the underwriters' option[97](index=97&type=chunk)[98](index=98&type=chunk)[190](index=190&type=chunk) - The net proceeds from the 2024 Offering are intended for Rezdiffra commercial activities, R&D, clinical trials, manufacturing, and potential ex-U.S. commercialization or partnering opportunities[99](index=99&type=chunk)[191](index=191&type=chunk) - The company entered into a 2024 Sales Agreement with Cowen, authorizing up to **$300.0 million** in common stock sales, but no sales were made under this agreement during the three and six months ended June 30, 2025[102](index=102&type=chunk)[177](index=177&type=chunk) [Stock-based Compensation](index=24&type=section&id=10.%20Stock-based%20Compensation) This section details the company's stock-based compensation expense and unrecognized compensation costs Stock-Based Compensation Expense (in thousands) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Stock options | $5,449 | $10,027 | $10,888 | $16,913 | | Restricted stock units | $14,328 | $9,918 | $26,116 | $18,543 | | Performance-based restricted stock units | $5,382 | $4,459 | $9,086 | $8,850 | | Total stock-based compensation expense | $25,159 | $24,404 | $46,090 | $44,306 | - Total stock-based compensation expense **increased slightly to $46.1 million** for the six months ended June 30, 2025, from $44.3 million in the prior year[113](index=113&type=chunk) - As of June 30, 2025, unrecognized stock-based compensation expense was **$247.4 million**, with a weighted average remaining period of **3.00 years**[113](index=113&type=chunk) [Commitments and Contingencies](index=26&type=section&id=11.%20Commitments%20and%20Contingencies) This section outlines the company's contractual obligations, milestone payments, and lease commitments - The company has approximately **$71.2 million in obligations** under contractual arrangements for active pharmaceutical ingredient, expected to be paid through March 2027[114](index=114&type=chunk) - Under the Hoffmann-La Roche agreement, remaining milestone payments total **$3.0 million** for future European regulatory approval of resmetirom, plus tiered single-digit royalties on net sales[116](index=116&type=chunk) - The company has expanded its office space through multiple lease amendments, with a new operating lease in April 2025 resulting in a **$4.0 million right-of-use asset and lease liability**[117](index=117&type=chunk)[118](index=118&type=chunk)[119](index=119&type=chunk) [Segment Information](index=27&type=section&id=12.%20Segment%20Information) This section clarifies that the company operates as a single reportable segment focused on MASH therapeutics - The company operates as **one reportable segment**, focused on delivering novel therapeutics for MASH[120](index=120&type=chunk) - The Chief Executive Officer reviews consolidated financials and qualitative information to evaluate performance and allocate resources on a total company basis[120](index=120&type=chunk) - As of June 30, 2025, the company did not have revenue or material assets outside of the U.S.[121](index=121&type=chunk) [Subsequent Events](index=27&type=section&id=13.%20Subsequent%20Events) This section reports significant events occurring after the reporting period, including financing and licensing agreements - On July 17, 2025, the company entered into the Blue Owl Credit Facility and used a portion of the proceeds to repay all outstanding obligations under the Hercules Loan Facility, totaling **$121.7 million**[123](index=123&type=chunk)[124](index=124&type=chunk) - In July 2025, the company entered an exclusive global license agreement with CSPC Pharmaceutical Group Limited for SYH2086, a preclinical oral GLP-1 receptor agonist[125](index=125&type=chunk) - Under the CSPC License Agreement, CSPC will receive an upfront payment of **$120.0 million** and is eligible for up to **$2.0 billion** in milestone payments, plus royalties on net sales, with clinical development expected in H1 2026[125](index=125&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, including a business overview, key developments, detailed analysis of revenues and expenses, and liquidity and capital resources [About Madrigal Pharmaceuticals, Inc.](index=29&type=section&id=About%20Madrigal%20Pharmaceuticals%2C%20Inc.) Madrigal Pharmaceuticals focuses on MASH, with Rezdiffra as its first and only FDA-approved therapy - Madrigal Pharmaceuticals is a biopharmaceutical company focused on **metabolic dysfunction-associated steatohepatitis (MASH)**, with Rezdiffra being its first and only FDA-approved therapy[128](index=128&type=chunk) - Rezdiffra is indicated for adults with noncirrhotic MASH with moderate to advanced liver fibrosis (F2 to F3) and is being evaluated for compensated MASH cirrhosis (F4c) to expand the eligible patient population[128](index=128&type=chunk)[129](index=129&type=chunk) - The company received a **positive opinion from the CHMP for resmetirom in Europe in June 2025**, with a European Commission decision anticipated in August 2025, and expects to launch in Germany in the second half of 2025[133](index=133&type=chunk)[134](index=134&type=chunk) [Key Developments](index=30&type=section&id=Key%20Developments) This section highlights significant corporate and product-related events during or after the reporting period - Daniel Brennan was appointed to the Board of Directors in **August 2025**[136](index=136&type=chunk) - In July 2025, the company entered an exclusive global license agreement for SYH2086, a preclinical oral GLP-1 receptor agonist, with CSPC Pharmaceutical Group Limited, involving an **upfront payment of $120.0 million** and potential milestones up to **$2.0 billion**[137](index=137&type=chunk) - A new **$500.0 million senior secured credit facility** with Blue Owl Capital Corporation was established in July 2025, and a new U.S. patent for Rezdiffra's dosing regimen was issued in August 2025, providing protection until **February 2045**[138](index=138&type=chunk)[139](index=139&type=chunk) [Basis of Presentation](index=31&type=section&id=Basis%20of%20Presentation) This section describes the accounting principles and assumptions used in preparing the financial statements and management's discussion - Product revenue from Rezdiffra sales, which began in April 2024, is recorded net of variable consideration including discounts, returns, chargebacks, rebates, and co-payment assistance[144](index=144&type=chunk) - Cost of sales is expected to increase as manufacturing costs, previously expensed as research and development prior to regulatory approval, are now capitalized as inventory[145](index=145&type=chunk) - Research and development expenses are expensed as incurred, covering clinical trials, manufacturing, and regulatory compliance, and are expected to remain substantial for the foreseeable future[146](index=146&type=chunk)[147](index=147&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) This section provides a comparative analysis of the company's financial performance for the three and six months ended June 30, 2025, and 2024, detailing changes in revenue, operating expenses, and net loss [Three Months Ended June 30, 2025 and 2024](index=32&type=section&id=Three%20Months%20Ended%20June%2030%2C%202025%20and%202024) This section analyzes the company's financial performance for the three-month periods ended June 30, 2025 and 2024 Three Months Ended June 30 (in thousands) | Item | 2025 | 2024 | Increase / (Decrease) ($) | Increase / (Decrease) (%) | | :-------------------------------- | :----- | :----- | :------------------------ | :------------------------ | | Product revenue, net | $212,802 | $14,638 | $198,164 | 1354 % | | Cost of sales | $9,065 | $636 | $8,429 | 1325 % | | Research and development | $54,081 | $71,091 | $(17,010) | (24)% | | Selling, general and administrative | $196,858 | $105,448 | $91,410 | 87 % | | Net loss | $(42,281) | $(151,971) | $109,690 | (72)% | - Product revenue, net, **surged by 1354% to $212.8 million** in Q2 2025 due to increased demand for Rezdiffra[156](index=156&type=chunk)[157](index=157&type=chunk) - Net loss **decreased by 72% to $(42.3) million**, despite a significant **87% increase in selling, general and administrative expenses** due to commercialization efforts[156](index=156&type=chunk)[160](index=160&type=chunk) [Six Months Ended June 30, 2025 and 2024](index=34&type=section&id=Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) This section analyzes the company's financial performance for the six-month periods ended June 30, 2025 and 2024 Six Months Ended June 30 (in thousands) | Item | 2025 | 2024 | Increase / (Decrease) ($) | Increase / (Decrease) (%) | | :-------------------------------- | :----- | :----- | :------------------------ | :------------------------ | | Product revenue, net | $350,052 | $14,638 | $335,414 | 2291 % | | Cost of sales | $13,578 | $636 | $12,942 | 2035 % | | Research and development | $98,253 | $142,328 | $(44,075) | (31)% | | Selling, general and administrative | $364,734 | $186,249 | $178,485 | 96 % | | Net loss | $(115,519) | $(299,512) | $183,993 | (61)% | - Product revenue, net, **increased by 2291% to $350.1 million** for the six months ended June 30, 2025, due to a full six months of Rezdiffra sales and increased demand[163](index=163&type=chunk)[164](index=164&type=chunk) - Research and development expenses **decreased by 31% to $98.3 million**, primarily due to changes in inventory accounting post-FDA approval and reduced clinical trial expenses[163](index=163&type=chunk)[166](index=166&type=chunk) - Net loss **decreased by 61% to $(115.5) million**, reflecting the substantial revenue growth[163](index=163&type=chunk) [Macroeconomic Events](index=35&type=section&id=Macroeconomic%20Events) This section discusses the potential impact of macroeconomic events and tariff policies on the company's business - The company believes current tariff policies will not materially impact its business due to U.S.-based manufacturing and commercialization of Rezdiffra[171](index=171&type=chunk) - A European manufacturer has been engaged for future commercial supply of drug product for European commercialization[171](index=171&type=chunk) - Future changes in global trade, economy, or market conditions could have an adverse effect on the business[171](index=171&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) This section details the company's funding history, cash position, future capital needs, and recent financing activities [At-the-Market Sales Agreement](index=35&type=section&id=At-the-Market%20Sales%20Agreement) This section details the company's at-the-market equity offering program and its current status - The company entered into a 2024 Sales Agreement with Cowen, authorizing the issuance and sale of up to **$300.0 million** in common stock[175](index=175&type=chunk) - No sales were made under the 2024 Sales Agreement during the three and six months ended June 30, 2025[177](index=177&type=chunk) - As of June 30, 2025, **$300.0 million remained available for sale** under the 2024 Sales Agreement[177](index=177&type=chunk) [Hercules Loan Facility](index=36&type=section&id=Hercules%20Loan%20Facility) This section describes the terms and recent repayment of the Hercules Loan Facility - As of June 30, 2025, the outstanding principal under the Hercules Loan Facility was **$115.0 million**, with an interest rate of **9.95%**[182](index=182&type=chunk) - The interest-only period was extended to May 3, 2027, and the maturity date to May 2027, following FDA approval and a revenue milestone[180](index=180&type=chunk) - On July 17, 2025, the facility was fully repaid and terminated, totaling **$121.7 million**, using proceeds from the new Financing Agreement[183](index=183&type=chunk) [Blue Owl Credit Facility](index=37&type=section&id=Blue%20Owl%20Credit%20Facility) This section outlines the terms of the new senior secured credit facility with Blue Owl Capital Corporation - On July 17, 2025, the company entered into a Financing Agreement with Blue Owl Capital Corporation, committing up to **$500.0 million** in senior secured credit facilities[184](index=184&type=chunk) - The Initial Term Loan of **$350.0 million** was funded on the closing date, with Delayed Draw Term Loans of up to **$150.0 million** available until December 31, 2027[184](index=184&type=chunk) - The Term Loans bear interest at **three-month SOFR (with a 1.0% floor) plus 4.75%** and have a stated maturity date of **July 17, 2030**, requiring a minimum unrestricted cash balance of **$100.0 million**[185](index=185&type=chunk)[187](index=187&type=chunk) [March 2024 Public Offering](index=37&type=section&id=March%202024%20Public%20Offering) This section details the net proceeds and intended use of funds from the company's March 2024 public offering - In March 2024, the company completed a public offering of common stock and pre-funded warrants, generating approximately **$659.9 million in net proceeds**[189](index=189&type=chunk)[190](index=190&type=chunk) - The proceeds are intended for commercial activities related to Rezdiffra's launch in the U.S., R&D, clinical trials, manufacturing, and potential ex-U.S. commercialization or partnering opportunities[191](index=191&type=chunk) [Cash Flows](index=38&type=section&id=Cash%20Flows) This section summarizes the company's net cash flow activities across operating, investing, and financing categories Summary of Net Cash Flow Activity (in thousands) | Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(135,943) | $(284,102) | | Net cash provided by (used in) investing activities | $211,736 | $(24,045) | | Net cash provided by financing activities | $10,381 | $707,829 | | Net increase in cash, cash equivalents, and restricted cash | $86,174 | $399,682 | - Net cash used in operating activities **decreased significantly to $(135.9) million in 2025 from $(284.1) million in 2024**[193](index=193&type=chunk)[194](index=194&type=chunk) - Investing activities shifted to a **net cash inflow of $211.7 million in 2025**, primarily from sales and maturities of marketable securities, compared to a net outflow in 2024[193](index=193&type=chunk)[195](index=195&type=chunk) [Contractual Obligations and Commitments](index=38&type=section&id=Contractual%20Obligations%20and%20Commitments) This section details the company's future payment obligations under various contractual agreements - The company has approximately **$71.2 million in obligations** for active pharmaceutical ingredient, payable through December 2027[202](index=202&type=chunk) - The Office Lease has been extended through November 2026 with additional space leased, and the new Blue Owl Credit Facility requires principal repayment only at maturity in July 2030[198](index=198&type=chunk)[199](index=199&type=chunk)[200](index=200&type=chunk) - The Roche Agreement mandates **tiered single-digit royalties** on net sales of Rezdiffra[201](index=201&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that there have been no material changes to the company's market risks since December 31, 2024, and no near-term changes in risk exposures or management strategies are anticipated - No material changes to the company's market risks have occurred since **December 31, 2024**[204](index=204&type=chunk) - No near-term changes in the nature of market risk exposures or management's objectives and strategies for managing such exposures are anticipated[204](index=204&type=chunk) [Item 4. Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, and reported no material changes in internal control over financial reporting during the quarter - The company's disclosure controls and procedures were evaluated and deemed **effective as of June 30, 2025**[206](index=206&type=chunk)[207](index=207&type=chunk) - No changes in internal control over financial reporting materially affected, or are reasonably likely to materially affect, internal control over financial reporting during the quarter ended June 30, 2025[209](index=209&type=chunk) - Management acknowledges that controls provide only reasonable, not absolute, assurance due to inherent limitations and resource constraints[208](index=208&type=chunk) [Part II. Other Information](index=41&type=section&id=Part%20II.%20Other%20Information) This part provides additional information not covered in financial statements, including legal proceedings and risk factors [Item 1. Legal Proceedings](index=41&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is **not party to any material legal proceedings**[211](index=211&type=chunk) [Item 1A. Risk Factors](index=41&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 - No material changes to the risk factors included in the Annual Report on Form 10-K for the year ended December 31, 2024[212](index=212&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=41&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report for the period - None to report for unregistered sales of equity securities and use of proceeds[213](index=213&type=chunk) [Item 3. Defaults Upon Senior Securities](index=41&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities to report for the period - None to report for defaults upon senior securities[214](index=214&type=chunk) [Item 4. Mine Safety Disclosures](index=41&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Mine Safety Disclosures are **not applicable** to the company[215](index=215&type=chunk) [Item 5. Other Information](index=41&type=section&id=Item%205.%20Other%20Information) This section reports on director and executive officer 10b5-1 plans and Daniel Brennan's appointment to the Board - No directors or officers adopted or terminated a Rule 10b5-1 trading plan or non-Rule 10b5-1 trading arrangement during the fiscal quarter ended June 30, 2025[216](index=216&type=chunk) - Daniel Brennan was elected as a Class II director to the Board, effective **August 1, 2025**, and appointed to the Audit Committee[217](index=217&type=chunk) - Mr. Brennan's compensation includes an annual cash fee of **$50 thousand**, an additional **$12.5 thousand** for Audit Committee service, and an equity grant valued at **$600 thousand** (**50% stock options, 50% restricted stock units**)[218](index=218&type=chunk) [Item 6. Exhibits](index=41&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed or furnished as part of this Quarterly Report on Form 10-Q, including agreements and certifications - Exhibits include a Letter Agreement with Rebecca Taub, M.D., an Offer Letter with David Soergel, M.D., and a Lease Agreement[222](index=222&type=chunk) - Certifications of the Principal Executive Officer and Principal Financial Officer pursuant to the Sarbanes-Oxley Act of 2002 are filed[222](index=222&type=chunk) - Inline XBRL Instance Document and Taxonomy Extension Documents are included[222](index=222&type=chunk) [Signatures](index=44&type=section&id=Signatures) This section contains the official signatures of the company's principal executive and financial officers, certifying the report - The report was signed on **August 5, 2025**, by William J. Sibold, President and Chief Executive Officer, and Mardi C. Dier, Executive Vice President and Chief Financial Officer[229](index=229&type=chunk)

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 ...

[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)