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Sep 30, 2021
Mirum Pharmaceuticals Q3 2021 Earnings Report
Mirum Pharmaceuticals reported financial results for the third quarter of 2021 and provided a business update.
Key Takeaways
Mirum Pharmaceuticals reported licensing revenue of $5.0 million for the quarter ended September 30, 2021, and a net loss of $47.1 million, or $1.55 per share. The company's cash, cash equivalents, and short-term investments totaled $205.0 million as of September 30, 2021. The FDA approval and launch of LIVMARLI capped a transformational third quarter for Mirum.
U.S. commercial launch underway following U.S. FDA approval of LIVMARLI (maralixibat) oral solution
Six-year analysis showing significant improvement in event-free survival with LIVMARLI compared to natural history cohort presented at AASLD.
The Lancet published data from the pivotal LIVMARLI ICONIC study demonstrating significant and durable responses in pruritus and other clinically meaningful improvements in patients with ALGS
Mirum will host a conference call today, November 15, 2021 at 1:30 p.m. PT/4:30 p.m. ET, to provide business updates and discuss data presented today at AASLD.
Forward Guidance
Mirum anticipates several milestones including Phase 3 MARCH-PFIC topline data expected in the second quarter of 2022, potential EMA approval of LIVMARLI for cholestatic liver disease in patients with ALGS in second half of 2022, and interim analyses expected in 2022 for the Phase 2b OHANA study for ICP and Phase 2b VISTAS study for PSC.
Positive Outlook
- Phase 3 MARCH-PFIC topline data expected in the second quarter of 2022.
- Potential EMA approval of LIVMARLI for cholestatic liver disease in patients with ALGS in second half of 2022
- Phase 2b EMBARK study for biliary atresia enrolling; topline data expected in 2023.
- Interim analyses expected in 2022 for the Phase 2b OHANA study for ICP
- Interim analyses expected in 2022 for the Phase 2b VISTAS study for PSC
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