Madrigal Pharmaceuticals (MDGL) Q4 2024 earnings summary

Executive summary

• Achieved FDA approval and commercial launch of Rezdiffra in March 2024, establishing it as the first approved therapy for MASH with moderate to advanced fibrosis and rapid inclusion in U.S. and European guidelines as first-line therapy.

• Generated $180.1 million in net sales for 2024, with $103.3 million in Q4, and over 11,800 patients on therapy by year-end, reflecting strong specialty prescriber uptake and less than 4% market penetration.

• Announced new two-year data from the MAESTRO-NAFLD-1 trial showing a mean 6.7 kPa reduction in liver stiffness for F4c patients, with 51% achieving ≥25% reduction, supporting benefit in high-risk cirrhosis.

• Positioned for European launch pending EMA approval, with CHMP opinion expected mid-2025 and initial launch in Germany.

• Expanded leadership and commercial teams to support global reach and ongoing clinical development.

Financial highlights

• Q4 2024 net sales were $103.3 million, up 66% quarter-over-quarter; full-year net sales reached $180.1 million, with no product sales in the prior year.

• Operating expenses for Q4 2024 were $170.3 million; full-year operating expenses rose to $678.0 million, mainly due to commercial launch activities.

• R&D expenses for 2024 were $236.7 million, down from $272.4 million in 2023, reflecting lower clinical trial accruals.

• SG&A expenses rose to $435.1 million in 2024 from $108.1 million in 2023, reflecting commercial scale-up.

• Ended 2024 with $931.3 million in cash and equivalents, supporting ongoing and planned launches, bolstered by a $659.9 million public offering.

Outlook and guidance

• Expect robust year-over-year net sales growth in 2025, with higher gross-to-net discounts typical for early specialty launches.

• SG&A and R&D expenses are projected to increase in 2025 to support U.S. and international expansion.

• No formal 2025 or 2026 guidance provided, but management is optimistic about continued momentum and consensus estimates may rise.

• Anticipates European approval and launch of Rezdiffra in the second half of 2025, starting with Germany.

• Ongoing MAESTRO-NASH OUTCOMES trial in F4c MASH patients, with data expected in 2027 to potentially expand the eligible patient population.