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Dec 31, 2022
Madrigal Q4 2022 Earnings Report
Madrigal reported Q4 2022 financial results and provided corporate updates.
Key Takeaways
Madrigal Pharmaceuticals reported positive Phase 3 MAESTRO-NASH study results in Q4 2022, positioning the company for a new drug application filing in the first half of 2023. The company's year-end cash, cash equivalents, and marketable securities totaled $358.8 million.
Positive Phase 3 MAESTRO-NASH study results were reported in December 2022.
Madrigal is preparing for a resmetirom new drug application filing in the first half of 2023.
Year-end cash, cash equivalents, and marketable securities were reported at $358.8 million.
The company is advancing regulatory filing preparations and prelaunch market development programs.
Madrigal
Madrigal
Forward Guidance
Madrigal is on track to file its NDA for resmetirom in the first half of 2023 supported by positive Phase 3 biopsy results and ongoing outcomes studies.
Positive Outlook
- NDA filing for resmetirom is on track for the first half of 2023.
- Filing is supported by positive Phase 3 biopsy results.
- Standalone Phase 3 safety study supports the filing.
- Two ongoing outcomes studies are designed to verify clinical benefit.
- MAESTRO-NASH outcomes portion is expected to be fully enrolled prior to NDA filing.
Challenges Ahead
- Potential regulatory delays or rejections.
- Risks associated with meeting the objectives of Madrigal’s clinical studies.
- Any delays or failures in enrollment, and the occurrence of adverse safety events.
- Market demand for and acceptance of our products.
- The potential inability to raise sufficient capital to fund ongoing operations as currently planned or to obtain financings on terms similar to those arranged in the past.