Financial Data and Key Metrics Changes - For Q1 2025, net sales totaled $137.3 million, representing a 33% increase from Q4 2024 [29][30] - R&D expenses decreased to $44.2 million from $71.2 million in Q1 2024, primarily due to changes in accounting for inventory costs and lower clinical trial costs [30] - SG&A expenses increased to $167.9 million from $80.8 million in Q1 2024, driven by increased commercial launch activities for Risdifa [31] Business Line Data and Key Metrics Changes - Risdifa generated $317 million in net sales over its first twelve months on the market, with Q1 2025 net sales of $137 million [8][29] - The number of patients on Risdifa increased to over 17,000 by the end of Q1 2025, up from 11,800 at the end of Q4 2024 [10][11] - Approximately 70% of the top 6,000 target prescribers have prescribed Risdifa, indicating strong physician adoption [13][15] Market Data and Key Metrics Changes - The target market consists of 315,000 diagnosed F2 and F3 MAH patients, with only about 5% currently being treated with Risdifa [11][12] - The company is focused on expanding its market presence, with plans to launch in Europe in the second half of 2025 [24] Company Strategy and Development Direction - The company aims to expand Risdifa's indication to F4C patients, which could potentially double its market opportunity [23] - Madrigal is also preparing for a mid-year regulatory decision in Europe and evaluating additional global markets [24][25] - The company is looking to build a pipeline of differentiated assets to extend its leadership position in NASH [25][88] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing demand for Risdifa and the company's strong positioning in the current macroeconomic environment [28] - The management team anticipates robust year-over-year net sales growth in 2025, despite expected increases in gross-to-net discounts as payer contracts are established [29][30] Other Important Information - The company has transitioned from an R&D-focused organization to a fully integrated commercial stage company following the approval of Risdifa [6] - The management highlighted the importance of patient education and awareness in driving treatment adoption [84] Q&A Session Summary Question: Expectations for growth trajectory for Risdifa with expanded label - Management expects continued growth and believes the market will expand significantly with the potential approval of SEMA [36][39] Question: Payer reauthorization requirements and patient persistency - Management is not concerned about reauthorizations and expects good persistency due to positive feedback from physicians and patients [42][45] Question: Status of European approval and launch strategy - The company is on track for a mid-year regulatory decision in Europe and is optimistic about the approval process [48][50] Question: Confidence in outcomes benefit on hepatic events - Management expressed confidence in the liver stiffness data and its relevance to patient outcomes [57][60] Question: Compliance rate and patient feedback on therapy - Early signs of adherence are promising, with patients reporting positive experiences on the drug [63][65] Question: Insights on gross-to-net pricing and payer discussions - Management is disciplined about gross-to-net pricing and anticipates it will evolve as payer contracts are established [68][106] Question: Feedback on DTC campaign and business development strategy - Positive feedback on the DTC campaign has been received, and the company is focused on building a pipeline to sustain its leadership position [82][87]