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Jun 30, 2021
Mirum Pharmaceuticals Q2 2021 Earnings Report
Reported financial results for the second quarter of 2021 and provided a business update.
Key Takeaways
Mirum Pharmaceuticals reported licensing revenue of $11.0 million for Q2 2021, stemming from a collaboration agreement. Total operating expenses were $48.4 million, resulting in a net loss of $43.9 million, or $1.45 per share. The company's cash, cash equivalents, and short-term investments amounted to $238.8 million as of June 30, 2021.
Entered into an exclusive licensing agreement with GC Pharma to develop and commercialize maralixibat in South Korea.
Presented maralixibat transplant-free survival data for PFIC2 and long-term safety analyses for ALGS at WCPGHAN Annual Meeting 2021.
Appointed Carol L. Brosgart, M.D. as an independent director to the Board of Directors.
FDA has issued a PDUFA date of September 29, 2021, for maralixibat in the U.S.
Forward Guidance
Mirum anticipates potential FDA approval of maralixibat and is advancing its late-stage clinical development pipeline. Topline data from the Phase 3 MARCH PFIC study is expected in the second quarter of 2022.
Positive Outlook
- The FDA has issued a PDUFA date of September 29, 2021, and, if approved, Mirum will launch maralixibat in the U.S. representing a commercial opportunity estimated at more than $500 million.
- Marketing authorization application (MAA) for PFIC2 decision expected in early 2022.
- Mirum plans to submit an MAA for ALGS in Europe based on results from the ICONIC study and six-year event-free survival analyses.
- Topline data from the Phase 3 MARCH PFIC study is expected in the second quarter of 2022.
- Enrollment ongoing in the potentially registrational Phase 2b OHANA study for ICP; interim analysis expected in 2022.
Challenges Ahead
- Research and development expenses for the quarter ended June 30, 2021 were $35.0 million, compared to $18.6 million for the comparable prior-year period.
- General and administrative expenses for the second quarter of 2021 were $13.4 million, compared to $5.0 million for the comparable prior-year period.
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