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Mar 31, 2023
Marinus Pharmaceuticals Q1 2023 Earnings Report
Marinus Pharmaceuticals reported first quarter 2023 financial results and provided a business update.
Key Takeaways
Marinus Pharmaceuticals reported ZTALMY U.S. net product revenue of $3.3 million for the first quarter of 2023. The company is on track to meet its full year revenue guidance of $15-17 million. They are planning an interim analysis for the Phase 3 refractory status epilepticus trial in the second half of 2023.
ZTALMY U.S. net product revenue was $3.3 million in Q1 2023.
An interim analysis for the Phase 3 refractory status epilepticus trial is planned for the second half of 2023.
CHMP opinion for ZTALMY in CDKL5 deficiency disorder is expected by the end of May.
Phase 3 tuberous sclerosis complex (TSC) trial data is now expected mid-2024.
Marinus Pharmaceuticals
Marinus Pharmaceuticals
Forward Guidance
Marinus Pharmaceuticals maintains its prior guidance for the fiscal year 2023.
Positive Outlook
- Expected ZTALMY U.S. net product revenues of between $15 million and $17 million.
- BARDA revenues in the range of $8 million to $11 million.
- Initiated U.S. onshoring of the manufacturing capabilities for ganaxolone API which has the potential to drive a greater than 30% reduction in API supply cost.
- Cash, cash equivalents, and short-term investments of $199.2 million as of March 31, 2023, will be sufficient to fund the Company’s operating expenses, capital expenditure requirements and maintain the minimum cash balance of $15 million required under the Company’s debt facility into the second half of 2024.
- Collaborating with Orion Corporation to prepare for a potential commercial launch in Europe
Challenges Ahead
- Total GAAP operating expenses, inclusive of SG&A and R&D, in the range of $165 to $175 million.
- Delays in clinical trials.
- Dependency on regulatory approvals.
- Potential for partners to breach obligations.
- The effect of the COVID-19 pandemic on our business