Madrigal Pharmaceuticals(MDGL) - 2025 Q1 - Quarterly Report

Financial Performance - For the three months ended March 31, 2025, the company recorded $137.3 million in product revenue, net, representing a 100$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$152.0 million in the same period last year[133]. - The net loss for the quarter was $73.2 million, a 50$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$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$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$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].