Madrigal Pharmaceuticals (MDGL) Q4 2024 earnings summary

Executive summary

• Achieved FDA approval and U.S. launch of Rezdiffra in March 2024, the first approved therapy for MASH with moderate to advanced fibrosis, with rapid commercial uptake and strong prescriber adoption.

• Generated $180.1M in net sales for 2024, with $103.3M in Q4, reflecting 66% quarter-over-quarter growth since launch in April and over 11,800 patients on therapy by year-end.

• Expanded Rezdiffra's reach with a European regulatory submission, CHMP opinion expected mid-2025, and initial launch planned in Germany in 2H25 pending EMA approval.

• Released 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 and a safety profile consistent with prior trials.

• Rezdiffra included as first-line therapy in updated U.S. and European guidelines by major liver societies.

Financial highlights

• Q4 2024 net sales: $103.3M; full year 2024 net sales: $180.1M, covering only nine months of commercialization.

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

• R&D expenses: $25.6M in Q4 and $236.7M for 2024, down from prior year due to lower clinical trial accruals and inventory accounting changes.

• SG&A expenses: $141.2M in Q4 and $435.1M for 2024, reflecting commercial scale-up post-approval.

• Ended 2024 with $931.3M in cash, cash equivalents, restricted cash, and marketable securities, boosted by a $659.9M public offering.

Outlook and guidance

• Expect robust year-over-year net sales growth in 2025, with higher gross-to-net discounts and increased R&D and SG&A expenses as launch and expansion continue.

• No formal guidance for 2025 or 2026, but management expects consensus estimates to narrow and increase based on current momentum.

• Preparing for a mid-year regulatory decision in Europe, with targeted launches starting in Germany and a disciplined, country-by-country approach.

• MAESTRO-NASH OUTCOMES trial in F4c MASH fully enrolled; data expected in 2027 to potentially expand the eligible patient population.

• Expects to expand Rezdiffra's indication to include compensated MASH cirrhosis if outcomes are positive.