RADNOR, PA — Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS) recenlty reported its financial results for the second quarter ending June 30, 2024, alongside significant business highlights that underscore the company’s progress in both financial performance and strategic initiatives.
ZTALMY® Revenue Growth
Marinus Pharmaceuticals achieved strong revenue growth for its flagship product, ZTALMY® (ganaxolone). The net product revenue for ZTALMY in Q2 2024 reached $8.0 million, representing an impressive 87% increase compared to the same period in 2023. This growth is attributed to increased adoption and appreciation from physicians, patients, and caregivers for ZTALMY’s role in treating CDKL5 deficiency disorder (CDD). The company is on track to meet its full-year 2024 revenue guidance of between $33 and $35 million for ZTALMY.
Expansion into Global Markets
The company has also made strides in expanding ZTALMY’s global footprint. Managed access programs have been activated in the Middle East and North Africa (MENA), Russia, and Canada, with upcoming commercial launches anticipated in Europe and China. ZTALMY was recently approved in China for patients with CDD, with a commercial launch planned for early 2025 by Tenacia Biotechnology. Orion Corporation is preparing for commercial launches in select European countries later this year.
“Since launching ZTALMY in the U.S. two years ago, we have seen significant growth and adoption with strong revenue for the second quarter, underscoring the appreciation physicians, patients and caregivers have for ZTALMY and its role in the treatment of CDKL5 deficiency disorder,” said Scott Braunstein, M.D., Chairman and Chief Executive Officer of Marinus. “We continue to grow the brand globally with ZTALMY now approved in the U.S., EU, UK and China. We look forward to continuing to expand access to this important treatment option while generating revenue from markets outside the U.S.”
Completion of TrustTSC Trial Enrollment
Marinus has successfully completed enrollment in the Phase 3 TrustTSC trial of oral ganaxolone in tuberous sclerosis complex (TSC). Topline data from this trial is expected in the first half of Q4 2024. The company is targeting the submission of a supplemental New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in April 2025, with a request for priority review. This trial has maintained a low discontinuation rate of less than 7%, with over 85% of patients continuing to the open-label extension.
Strategic Plans and Future Outlook
Dr. Braunstein highlighted the company’s strategic plans: “Our proven commercial infrastructure and success in CDD provides us with a solid foundation to expand into TSC, which represents a significant unmet need in a larger refractory epilepsy population. With enrollment complete in the Phase 3 TrustTSC trial and data upcoming, we continue to make the appropriate investments and plan for a potential launch in the fall of 2025.”
Marinus will host an investor and analyst event on September 20, 2024, to discuss the TSC opportunity, where senior management and key opinion leaders will provide insights into the treatment landscape, market potential, and commercial opportunity for ZTALMY in TSC.
Financial Performance and Updates
For Q2 2024, Marinus reported a net loss of $35.8 million, or $(0.12) per share, compared to a net loss of $11.4 million, or $(0.07) per share, for the same period in 2023. Research and development expenses increased to $20.9 million, primarily due to costs associated with the molgramostim program. General and administrative expenses rose to $16.7 million, driven by increased commercial spending and headcount costs.
Despite these expenses, Marinus executed cost reduction plans expected to lower combined selling, general and administrative (SG&A) and R&D expenses by approximately 30% in the second half of 2024. The company’s cash and cash equivalents stood at $64.7 million as of June 30, 2024, which is expected to fund operations into the second quarter of 2025.
Conclusion
Marinus Pharmaceuticals continues to demonstrate strong financial performance and strategic progress. The company’s focus on expanding ZTALMY’s global presence and advancing its clinical pipeline positions it well for future growth and success in addressing unmet medical needs in the epilepsy and rare disease markets.
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