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Sep 30, 2022
Marinus Pharmaceuticals Q3 2022 Earnings Report
Marinus Pharmaceuticals' financial position was updated for Q3 2022, highlighted by ZTALMY's U.S. launch and strategic financial moves to extend cash runway.
Key Takeaways
Marinus Pharmaceuticals reported Q3 2022 financial results, marked by the U.S. commercial launch of ZTALMY which generated $0.56 million in net product revenue. Strategic financial decisions, including the sale of a Priority Review Voucher and a revenue interest financing agreement, are expected to extend the company's cash runway into Q1 2024.
ZTALMY U.S. launch initiated in late July with over 50 completed CDKL5 deficiency disorder prescription enrollment forms.
Approximately 40% of CDD patients with completed prescription enrollment forms were on reimbursed therapy by the end of Q3.
ZTALMY generated $0.56 million in net product revenue for the first partial quarter following launch.
Cash runway projected to extend into Q1 2024 following strategic financial transactions.
Marinus Pharmaceuticals
Marinus Pharmaceuticals
Forward Guidance
Marinus Pharmaceuticals anticipates continued progress with its clinical trials and commercial activities, with key data readouts expected in the near future and ongoing efforts to expand the availability of ZTALMY.
Positive Outlook
- Topline results from the Phase 3 RAISE trial in refractory status epilepticus are expected in the second half of 2023.
- Topline data from the Phase 3 TrustTSC trial in tuberous sclerosis complex is anticipated in the first quarter of 2024.
- The company is on track to submit complete responses to the EMA for the Marketing Authorization Application for ZTALMY by the end of November 2022.
- A Phase 2 trial in Lennox-Gastaut syndrome is targeted to begin in 2023.
- Prodrug development continues to advance with Phase 1 data targeted for 2024.
Challenges Ahead
- Unexpected results or delays in the commercial launch of ZTALMY, including potential delays caused by the current COVID-19 global pandemic.
- Unexpected market acceptance, payor coverage or future prescriptions and revenue generated by ZTALMY.
- Unexpected actions by the FDA or other regulatory agencies with respect to our products.
- Competitive conditions and unexpected adverse events or patient outcomes from being treated with ZTALMY.
- The company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated.