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]