Marinus Pharmaceuticals Q2 2024 Financial Results and Business Update

Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a company focused on developing innovative treatments for seizure disorders, has announced notable business developments and financial results for the second quarter ending June 30, 2024.

According to Scott Braunstein, M.D., the Chairman and CEO of Marinus, the U.S. launch of their product ZTALMY has seen substantial growth over the past two years. The second quarter witnessed strong revenue, emphasizing the positive reception from physicians, patients, and caregivers for its role in treating CDKL5 deficiency disorder (CDD). ZTALMY is currently approved in the U.S., EU, UK, and China, with ongoing efforts to expand its global market reach and generate revenue outside the U.S.

Braunstein highlighted the company's strategic goals, including expansion into tuberous sclerosis complex (TSC), an area of significant unmet needs in the epilepsy population. The Phase 3 TrustTSC trial has completed enrollment, and top-line data is expected in the fourth quarter of 2024. Marinus anticipates a potential launch of ZTALMY for TSC by fall 2025, with plans to discuss its market potential and commercial opportunities at an investor and analyst event on September 20th.

ZTALMY generated net product revenue of $8.0 million in Q2 2024, an 87% increase compared to Q2 2023. The company expects to meet its 2024 net product revenue guidance of $33-$35 million. Global access continues to grow with managed access programs now active in regions like the Middle East, North Africa (MENA), Canada, and Russia. ZTALMY's approval in China will see a commercial launch by Tenacia Biotechnology in early 2025. Orion Corporation is also preparing for launches in select European countries in the second half of 2024.

In the clinical pipeline, Marinus has completed patient enrollment for its Phase 3 TrustTSC trial concerning oral ganaxolone for tuberous sclerosis complex (TSC). Top-line data is expected in late 2024, with a supplemental New Drug Application (NDA) submission to the FDA slated for April 2025. The TrustTSC trial reports a low discontinuation rate and high patient continuation in open-label extensions. Launch and market access planning are in progress for a commercial release in the latter half of 2025.

Additionally, Marinus plans to initiate a proof-of-concept study using ZTALMY for a range of developmental and epileptic encephalopathies, including Lennox-Gastaut syndrome, in early 2025, pending positive TSC data. The company also targets a submission of an Investigational New Drug application for a new ganaxolone prodrug by late 2025.

In the area of status epilepticus, Marinus has announced results from the Phase 3 RAISE trial utilizing intravenous (IV) ganaxolone. A meeting with the FDA is planned to discuss these results and the next steps for the IV ganaxolone program. The company continues to offer IV ganaxolone for super refractory status epilepticus under emergency investigational new drug applications.

Financially, Marinus reported robust measures to stabilize and enhance its fiscal standing. The Patent Trial and Appeal Board recently issued a favorable decision in the post-grant review of Ovid Therapeutics' U.S. patent for IV ganaxolone. Marinus has also restructured agreements with Oaktree Capital Management and Sagard Healthcare Partners, removing a $15 million minimum liquidity requirement and reducing 2024 amortization payments by 50%. These and other cost reduction initiatives are expected to decrease combined SG&A and R&D expenses by about 30% in the latter half of 2024.

The company recognized $8.0 million in net product revenue for Q2 2024, with federal contract revenue declining due to the completion of certain project phases. R&D expenses were slightly lower due to reduced personnel costs, while SG&A expenses increased owing to heightened commercial activities. Marinus reported net losses of $35.8 million for Q2 2024, with cash and cash equivalents at $64.7 million as of June 30, 2024, projected to fund operations into the second quarter of 2025.

Overall, Marinus continues to strengthen its financial position and expand the global reach and application of ZTALMY, while advancing its clinical pipeline to address significant unmet needs in seizure disorder treatments.

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