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Mar 31, 2021
Mirum Pharmaceuticals Q1 2021 Earnings Report
Mirum Pharmaceuticals reported financial results for Q1 2021 and provided a business update.
Key Takeaways
Mirum Pharmaceuticals reported a net loss of $50.5 million for the quarter ended March 31, 2021. The company is preparing for the potential launch of maralixibat for Alagille syndrome with a PDUFA date of September 29, 2021.
NDA for maralixibat in Alagille syndrome (ALGS) granted priority review by U.S. FDA with a PDUFA date of September 29, 2021.
Received additional $65.0 million in funding from Oberland Capital based on NDA acceptance.
Commercial team hired in anticipation of U.S. launch of maralixibat in ALGS.
Entered into two licensing agreements with Vivet Therapeutics and CANbridge Pharmaceuticals.
Forward Guidance
Mirum is preparing for the potential launch of maralixibat and advancing its pipeline.
Positive Outlook
- FDA has issued a PDUFA date of September 29, 2021 for maralixibat in ALGS.
- Mirum plans to launch maralixibat for the treatment of cholestatic pruritus in patients with ALGS one year of age and older in the United States, if approved.
- Mirum is planning to launch maralixibat for the treatment of PFIC2 in Europe in early 2022, if approved by the European Medicines Agency.
- Mirum plans to file for ALGS as an additional indication in Europe following the PFIC2 approval, if received, based on results from the ICONIC study and six-year event-free survival analyses.
- Phase 2b study in primary biliary cholangitis (PBC) planned for the second half of 2021.
Challenges Ahead
- Topline data from the Phase 3 MARCH PFIC study expected in early 2022.
- Continuing enrollment in EMBARK Phase 2b study of maralixibat in biliary atresia.
- Continuing enrollment in Phase 2b OHANA study for intrahepatic cholestasis of pregnancy (ICP).
Historical Earnings Impact
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