Madrigal Q3 Earnings Miss, MASH Drug Sales Drive Top Line, Stock Up

Core Insights - Madrigal Pharmaceuticals (MDGL) reported a third-quarter 2025 loss of $5.08 per share, which is wider than the Zacks Consensus Estimate of a loss of $1.98, and compared to a loss of $4.92 per share in the same quarter last year [1][6] - The company generated total revenues of $287.3 million from product sales of its MASH drug Rezdiffra, surpassing the Zacks Consensus Estimate of $249 million, indicating strong year-over-year growth driven by increased demand [2][6] - MDGL shares increased by 7.8% following the announcement of strong sales growth [3] Financial Performance - Research and development expenses more than doubled to $174 million in Q3 2025, primarily due to upfront expenses for CSPC Pharma, partially offset by reduced clinical study expenses [5] - Selling, general and administrative expenses nearly doubled to $209.1 million, attributed to increased commercial launch activities for Rezdiffra [8] - Madrigal's cash, cash equivalents, and marketable securities amounted to $1.1 billion as of September 30, 2025, up from $802 million as of June 30, 2025, reflecting a new $350 million senior secured term loan with Blue Owl Capital [9] Product and Market Updates - Rezdiffra received accelerated approval from the FDA in March 2024, becoming the first and only approved therapy for MASH, with over 29,500 patients currently receiving treatment and more than 10,000 healthcare providers prescribing it as of September 30, 2025 [4][10] - The European Commission granted conditional marketing authorization to Rezdiffra in August 2025, making it the first approved therapy for MASH in the EU, with a launch in Germany in September [10] - Madrigal finalized a global licensing deal with CSPC Pharma for MGL-2086, an oral GLP-1 agonist, to combine with Rezdiffra in MASH treatment, with clinical entry expected in the first half of 2026 [11] Ongoing Studies and Future Prospects - The FDA's continued approval of Rezdiffra will depend on long-term safety and efficacy data from the ongoing pivotal phase III MAESTRO-NASH biopsy study [12] - A second phase III outcomes study (MAESTRO-NASH OUTCOMES) is underway, with top-line data expected in 2027, which could support full approval for Rezdiffra and expand its eligible patient population [13] - Positive two-year data from the open-label extension of the MAESTRO-NAFLD-1 study reinforces Rezdiffra's potential benefits for patients with compensated MASH cirrhosis [14]