Madrigal Q4 2019 Earnings Report
Key Takeaways
Madrigal Pharmaceuticals reported a net loss of $27.74 million for the fourth quarter of 2019, with operating expenses totaling $30.0 million, driven primarily by increased research and development expenses related to Phase 3 studies. As of December 31, 2019, the company's cash, cash equivalents, and marketable securities amounted to $439.0 million.
Madrigal initiated two Phase 3 studies in NASH: MAESTRO-NASH and MAESTRO-NAFLD-1.
The company expanded its medical operations team and added Jim Daly to its Board.
Madrigal believes it has sufficient financial resources to fund its two ongoing Phase 3 clinical studies.
Both Phase 3 studies are on track to complete enrollment this year for the 52 week readout by the end of 2021.
Madrigal
Madrigal
Forward Guidance
Madrigal is focused on the clinical development of resmetirom and anticipates completing enrollment for its Phase 3 studies, MAESTRO-NASH and MAESTRO-NAFLD-1, with a 52-week readout expected by the end of 2021.
Positive Outlook
- Phase 3 studies MAESTRO-NASH and MAESTRO-NAFLD-1 are on track for enrollment completion in 2020.
- 52-week readout from Phase 3 studies expected by the end of 2021.
- MAESTRO-NAFLD-1 includes an open label active treatment arm providing data on lipids and non-invasive NASH biomarkers in 2020.
- Resmetirom has the potential to resolve NASH and reduce liver fibrosis.
- Resmetirom may decrease cardiovascular risk through reduction of atherogenic lipids.
Challenges Ahead
- Clinical development of resmetirom is subject to enrollment uncertainties.
- Outcomes from competitive studies could impact resmetirom's prospects.
- Achieving potential benefits in larger studies carries inherent risks.
- Timing and outcomes of resmetirom's clinical studies are uncertain.
- Clinical testing inherently involves uncertainties.