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Sep 30, 2022
Mirum Pharmaceuticals Q3 2022 Earnings Report
Reported financial results for the third quarter of 2022 and provided a business update.
Key Takeaways
Mirum Pharmaceuticals reported net product sales of $18.8 million for LIVMARLI in Q3 2022. The company is well positioned for European approval by the end of the year and raised its full year net product sales guidance estimate for LIVMARLI to $70 million.
LIVMARLI net product sales totaled $18.8 million in Q3 2022.
Mirum raised 2022 full year net product sales guidance estimate for LIVMARLI to $70 million.
Positive topline data from LIVMARLI Phase 3 MARCH study in PFIC was announced.
A positive CHMP opinion for LIVMARLI for cholestatic pruritus in patients with ALGS was announced.
Forward Guidance
Mirum anticipates a European Commission decision regarding approval of LIVMARLI for the treatment of cholestatic pruritus in patients with Alagille syndrome two months of age and older, in the fourth quarter of 2022. Topline data in the EMBARK Phase 2b clinical trial for biliary atresia is expected in the second half of 2023. Interim analysis for the VISTAS Phase 2b clinical trial for primary sclerosing cholangitis is expected in mid-2023. Interim analysis for the OHANA Phase 2b clinical trial for intrahepatic cholestasis of pregnancy is expected in the first half of 2023. Interim analysis for the VANTAGE Phase 2b clinical trial for primary biliary cholangitis is expected in the second half of 2023.
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