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Dec 31, 2021
Mirum Pharmaceuticals Q4 2021 Earnings Report
Reported financial results for the fourth quarter and year-end 2021 and provided a business update.
Key Takeaways
Mirum Pharmaceuticals reported Q4 2021 financial results, highlighted by net product revenue of $3.1 million from LIVMARLI, marking a strong start to its commercial launch. The company also sold a Rare Pediatric Disease Priority Review Voucher for $110.0 million, contributing to a net income of $57.5 million for the quarter.
Launched LIVMARLI in the United States as the first and only medicine approved for cholestatic pruritus in patients with Alagille syndrome one year of age and older.
Sold Rare Pediatric Disease Priority Review Voucher (PRV) for $110.0 million.
Presented data highlighting LIVMARLI's durable improvements across multiple cholestasis parameters.
Partner GC Pharma submitted a pharmaceutical approval application to the Ministry of Food and Drug Safety in Korea for LIVMARLI for the treatment of cholestatic pruritus in patients with Alagille syndrome.
Forward Guidance
Mirum Pharmaceuticals anticipates several milestones, including launching commercial early access programs in international markets for LIVMARLI, topline data from the MARCH-PFIC Phase 3 clinical trial, and Alagille syndrome launch in Europe.
Positive Outlook
- Launch commercial early access programs in international markets for LIVMARLI in the first half of 2022.
- Topline data from MARCH-PFIC Phase 3 clinical trial expected in the fourth quarter of 2022.
- Alagille syndrome launch in Europe in the fourth quarter 2022, if approved by the EMA.
- Interim analyses expected for VISTAS Phase 2b clinical trial for primary sclerosing cholangitis in the fourth quarter of 2022.
- First interim analysis expected for OHANA Phase 2b clinical trial for intrahepatic cholestasis of pregnancy in the fourth quarter of 2022.
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