MADRIGAL PHARMACEUTICALS, INC. Q1 FY2025 earnings call

• Recognized Becky Taub's role as Senior Scientific and Medical Advisor and Dave Soergel joining as Chief Medical Officer. - Rezdiffra's US launch momentum, with two-year F4c data selected for EASL Congress and an investor webcast on May 13th to review this data. - Progress with Rezdiffra: over 17,000 patients on therapy, 70% of 6,000 top targets have prescribed, 50% of 14,000 target prescribers have prescribed. - Efficacy of Rezdiffra in reducing liver stiffness, liver fat, etc., and ongoing trials in F4c patients. - Strategy to expand leadership in MASH, including evaluating Rezdiffra in F4c patients and potential EMA approval in Europe with a planned launch in Germany in H2 2025.

Rezdiffra's first quarter 2025 net sales totaled $137.3 million, up 33% from the fourth quarter of 2024. Rezdiffra has over 17,000 patients on therapy, 70% of 6,000 top targets have prescribed it, and approximately 50% of 14,000 target prescribers had prescribed it at the end of Q1 2025. Revenue contribution is primarily from the US launch of Rezdiffra.

• First quarter 2025 net sales were $137.3 million, up 33% quarter-over-quarter. - Expect robust year-over-year net sales growth in 2025. - SG&A expenses expected to increase in 2025 due to commercial launch activities for Rezdiffra, including investment in the US launch and preparation for Europe launch. - Anticipate EMA approval mid-year and launch in Germany in the second half of 2025.

• Reauthorizations are part of the process for any medicine, but not seen as a concern due to positive real-world results from physicians and patients. - Uncertainty around payer reauthorization requirements and market dynamics with new entrants like GLP-1s, though Rezdiffra's profile is seen as strong.

Q: Curious to go a little bit more in depth on your expectations for the growth trajectory for Rezdiffra, particularly when sema's label is expanded to include MASH.

A: Bill and Mardi discuss growth potential with sema's label expansion, noting there's years of growth in the market ahead with Rezdiffra's profile.

Q: Could you just talk us through your expectations around payer reauthorization requirements that you might be seeing right now?

A: Bill addresses payer reauthorizations as part of the process, not a concern due to positive real-world results from physicians and patients.

Q: Can you talk about your relative confidence in showing an outcomes benefit on hepatic events in F2-F3 versus F4?

A: Bill discusses confidence in liver stiffness data translating to outcomes benefit, citing mechanistic and data support.

Q: My question is just now that you've had patients for over a year on therapy, have you been able to quantify sort of what the compliance rate is...

A: Bill talks about early positive signs for adherence rates, noting well-tolerated nature and positive patient feedback.

Q: If you could give any more granularity on gross to net for the quarter...

A: Bill and Mardi discuss gross to net dynamics and GLP-1 patient mix, with 25% of Rezdiffra patients on GLP-1s.

Q: Can you talk about any feedback on the key messages in your DTC campaign...

A: Bill discusses DTC campaign feedback and business development strategy, emphasizing the importance of education.

Q: Digging into the Novo's New England publication from last night on ESSENCE...

A: Bill comments on the publication, stating nothing new from Rezdiffra's perspective and discussing patient segmentation.

Q: A follow-up on gross to net as well, but maybe longer term for 2026 and beyond...

A: Bill and Mardi discuss long-term gross to net and business development capacity, noting disciplined approach.

Q: You mentioned six abstracts will be presented at EASL next week...

A: Bill talks about EASL presentations, particularly the late-breaking F4c data and upcoming investor webcast on May 13th