Madrigal Pharmaceuticals, Inc. Q3 FY2025 earnings call

• Rezdiffra is quickly becoming a successful specialty launch with sales annualizing over $1 billion in six months. Over 29,500 patients are on therapy and over 10,000 prescribers have used it. - Made progress on 2026 payer contracting with broad first-line access, no step edit requirements, and improved utilization management. - Pipeline advancements include Phase III MAESTRO-NASH outcomes trial in F4c, and adding an oral GLP-1 (MGL-2086) through business development. - EU launch started in Germany with efforts to wire the system for adoption. - SG&A expenses include build-out for Germany, with discipline in country-by-country EU launches considering 2-3 year positive contribution metrics.

Rezdiffra was the key segment. In the third quarter, Rezdiffra delivered net sales of $287 million, up 35% quarter-over-quarter. It's annualizing at greater than $1 billion in sales in its sixth quarter of launch. More than 29,500 patients are being treated with Rezdiffra, and more than 10,000 healthcare providers have prescribed it. Revenue contribution is primarily from Rezdiffra as it's the main product driving the segment.

• Rezdiffra is expected to have robust net sales growth in 2026. - Gross to net impact is expected to be in the high 30% range starting January 2026. - Phase I trial for MGL-2086 is planned for the first half of next year. - EU launch will contribute to growth over time but is phased with a focus on disciplined country-by-country expansion.

• Potential challenges in payer negotiations and maintaining favorable gross to net. - Competition from other products in the MASH space, including GLP-1s and other potential therapies. - Uncertainties in EU launch adoption and market acceptance over time.

Q: What's your view on Madrigal's future competitive positioning and market access once large pharma bundles their MASH assets?

A: William Sibold stated that recent M&A validates the MASH market, and Madrigal's long-term approach with Rezdiffra's IP to 2045 positions them well. They are focused on broad first-line access and think their profile favors them in the long run.

Q: Can you confirm Rezdiffra's adherence rate and how it informs long-term chronic use potential?

A: William Sibold and David Soergel mentioned that well-tolerated orals have a 60%-70% adherence rate at 1 year, and Rezdiffra's profile, including sustained efficacy and tolerability, gives confidence in its long-term chronic use potential.