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Dec 31, 2020
Madrigal Q4 2020 Earnings Report
Madrigal Pharmaceuticals reported fourth quarter and full year financial results for 2020.
Key Takeaways
Madrigal Pharmaceuticals reported operating expenses of $59.6 million and research and development expenses of $53.4 million for the three months ended December 31, 2020. As of December 31, 2020, Madrigal had cash, cash equivalents and marketable securities of $284.1 million.
Completed enrollment in the Phase 3 MAESTRO-NAFLD-1 trial in less than 12 months.
Made significant progress in enrollment of the Phase 3 MAESTRO-NASH trial.
Advanced the development of Madrigal’s commercial capabilities.
Expect to achieve several important clinical milestones in 2021, including completion of enrollment in the 52-week, serial liver biopsy population for Subpart H approval of MAESTRO-NASH.
Madrigal
Madrigal
Forward Guidance
Madrigal expects to achieve several important clinical milestones in 2021, including completion of enrollment in the 52-week, serial liver biopsy population for Subpart H approval of MAESTRO-NASH, which we expect to complete in the second quarter; presentation of data from the open label arm of MAESTRO-NAFLD-1 at a major medical conference; and release of topline data from the blinded arms of MAESTRO-NAFLD-1 by the end of the year.
Positive Outlook
- Completion of enrollment in the 52-week, serial liver biopsy population for Subpart H approval of MAESTRO-NASH.
- Presentation of data from the open label arm of MAESTRO-NAFLD-1 at a major medical conference.
- Release of topline data from the blinded arms of MAESTRO-NAFLD-1 by the end of the year.
- Resmetirom lowers multiple atherogenic lipids, including LDL cholesterol, apolipoprotein B, triglycerides, and lipoprotein (a).
- Resmetirom’s ability to decrease liver fat.
Challenges Ahead
- Clinical development of resmetirom
- Enrollment uncertainties, generally and in relation to COVID-19 shelter-in-place and social distancing measures and individual precautionary measures that may be implemented or continued for an uncertain period of time
- Outcomes or trends from competitive studies
- Future topline data timing or results
- The risks of achieving potential benefits in studies that include substantially more patients than our prior studies