Madrigal Pharmaceuticals(MDGL) - 2025 Q2 - Earnings Call Transcript

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]