Madrigal Pharmaceuticals (MDGL) FY Conference Transcript

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.