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Jun 30, 2022
Marinus Pharmaceuticals Q2 2022 Earnings Report
Marinus Pharmaceuticals prepared for ZTALMY commercial launch and progressed Phase 3 trials.
Key Takeaways
Marinus Pharmaceuticals reported financial results for the second quarter ended June 30, 2022. The company continued to prepare for the commercial launch of ZTALMY and progressed its Phase 3 TrustTSC and RAISE trials.
ZTALMY is now available for healthcare professionals to prescribe in the U.S.
Second generation ganaxolone formulation showed encouraging Phase 1 results.
Phase 3 RAISE trial protocol amendment expected to be implemented by the end of Q3, with data readout expected in 2H 2023.
First patient dosed in Phase 3 TrustTSC trial, with data anticipated in Q1 2024.
Marinus Pharmaceuticals
Marinus Pharmaceuticals
Marinus Pharmaceuticals Revenue by Segment
Forward Guidance
Marinus Pharmaceuticals provided financial guidance for the fiscal year 2022, focusing on BARDA revenues and total GAAP operating expenses.
Positive Outlook
- Concentrating 2022–2023 focus on key clinical programs and commercial launch
- Marinus expects a lump sum payment in August 2022 upon the closing of the PRV transaction, strengthening their cash position
- First patient randomized and dosed in Phase 3 TrustTSC trial
- Expect to submit complete responses to the European Medicine Agency (EMA) Day 120 List of Questions for the Marketing Authorization Application (MAA) for ZTALMY by the end of November 2022
- Plans are underway to expand strategic commercial alliances to bring ZTALMY to additional ex-U.S. geographies
Challenges Ahead
- The Company reported net losses of $39.4 million for the three months ended June 30, 2022
- Cash used in operating activities increased to $61.3 million for the six months ended June 30, 2022
- Clinical trial results may not support regulatory approval or further development in a specified indication or at all
- The potential for Orion to breach the collaboration or terminate the agreement in accordance with its terms
- company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated