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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.

EPS
-$3.82
Previous year: -$1.8
+112.2%
R&D Expense
$53.4M
Previous year: $24.9M
+114.5%
SG&A Expense
$6.13M
Previous year: $5.04M
+21.5%
Cash and Equivalents
$284M
Previous year: $439M
-35.3%
Free Cash Flow
-$55M
Total Assets
$287M

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