MADRIGAL PHARMACEUTICALS, INC. Q4 FY2024 earnings call

• Rezdiffra Launch: Ended 2024 strong with $103M Q4 net sales, 66% QoQ growth. Full year 2024 net sales $180M. Launched in April 2024, with over 11,800 patients on therapy by end of Q4 2024. 60% of top 6,000 target prescribers prescribed in Q4.
• F4c MASH Trial Data: New two-year data from open-label study for F4c patients showed a mean 6.7 kPa reduction in liver stiffness at two years, highly statistically significant vs baseline. 51% of patients achieved 25% or greater decrease in liver stiffness. Safety profile consistent with other Rezdiffra trials.
• Geographic Expansion: On-track for mid-year regulatory decision in Europe, plan country-by-country commercialization starting with Germany in H2 2025. Advancing Rezdiffra for compensated MASH cirrhosis, with MAESTRO-NASH outcomes trial ongoing.
• Financials: Q4 2024 net sales $103.3M, full year $180.1M. R&D expenses decreased in 2024 due to reduced clinical trial accruals, but expected higher in 2025. SG&A expenses increased in 2024 due to scale-up of U.S. commercial ops, expected to increase in 2025. Strong balance sheet with $931.3M in cash, etc. at end of 2024.

In the fourth quarter of 2024, Madrigal Pharmaceuticals generated $103 million in net sales for Rezdiffra, representing a 66% quarter-over-quarter growth. For the full year 2024, Rezdiffra contributed $180 million in net sales. The U.S. launch of Rezdiffra is a key segment, with the product having been launched in April 2024 and showing strong growth trajectory with over 11,800 patients on therapy by the end of Q4 2024 and 60% of top 6,000 target prescribers having prescribed Rezdiffra in Q4.

• Expect higher R&D and SG&A spend in 2025 compared to 2024. - Consensus for Q1 2025 to narrow and increase based on momentum seen in Q1 2025. - No specific full-year 2025 guidance yet, but expecting robust year-over-year net sales growth.

• Potential competitive pressures from future entrants in the MASH market. - Regulatory hurdles in Europe regarding pricing and health technology assessments. - Impact of Part D redesign on gross-to-net margins, though Mardi noted impact is incremental in 2025.

Q: Thomas Smith asked about Q1 2025 patient adds and guidance A: Bill Sibold said 2025 has seen steady addition of patients and prescribers, tracking well with blockbuster launch metrics. Mardi Dier noted consensus for Q1 2025 to narrow and increase based on seen momentum Q: Andrea Newkirk asked about clinical meaningfulness of 6.7 kPa reduction and NASH outcomes trial A: Bill Sibold said this data gives greater confidence in MAESTRO-NASH outcomes trial. Michael Charlton explained that a 6.7 kPa reduction is highly statistically significant vs baseline and predictive of reduced risk of clinical outcomes Q: Yasmeen Rahimi asked about guidance A: Mardi Dier said they are not giving specific guidance yet, but consensus for 2025 is expected to narrow and increase based on seen momentum Q: Ellie Merle asked about F4 data and study timing A: Bill Sibold said more detailed data to come at upcoming medical meeting. Michael Charlton noted the 6.7 kPa reduction is a meaningful finding Q: Amy Li asked about competitor FGF21 data and Part D A: Bill Sibold said they are not commenting on competitive data but are confident in their own data. Mardi Dier said Part D impact is incremental in 2025 with everything going as expected Q: Liisa Bayko asked about kilopascal change context and semaglutide A: Michael Charlton explained that a 5 kPa or 25% reduction in liver stiffness is predictive of reduced fibrosis stage. Bill Sibold said they are confident in their profile and expect semaglutide to drive market growth benefiting them Q: David Lebowitz asked about GLP-1 impact A: Bill Sibold said 25% of Rezdiffra patients are already on GLP-1s, and they believe GLP-1s will drive market expansion benefiting them as the leader Q: Andy Chen asked about Europe launch challenges A: Bill Sibold said they will be country-by-country, disciplined, and expect to be positive contribution in countries where value is recognized. Pricing will be argued based on product value Q: Ritu Baral asked about HTA algorithms and safety A: Bill Sibold said they will go through formal HTA processes and their data supports value. Michael Charlton said safety in F4 open-label dataset was comparable to non-cirrhotic disease patients Q: Prakhar Agrawal asked about GI vs hepatologist prescribers A: Bill Sibold said gastroenterologists are a major part of prescribers, with 60% of top 6,000 targets prescribing, and they are seeing strong adoption and prescription growth Q: Catherine Okoukoni asked about dose adjustment and patient retention A: Michael Charlton said 122 patients entered the second year of the open-label extension, data from 101 with second VCTE, and all stayed on 80 mg dose