RADNR, PA — Marinus Pharmaceuticals, a leading biopharmaceutical company, reported impressive growth and financial performance for the fourth quarter and also for the year ending December 31, 2023, making a mark in the pharmaceutical industry.
The company reported notable milestones this year, including exceeding the necessary enrollment threshold for its Phase 3 RAISE trial. This trial targets refractory status epilepticus – a perilous and potentially deadly condition. “We’re anticipating to release top-line data in Q2, presuming the efficacy criteria for the interim analysis are met,” shared Scott Braunstein, M.D., Chairman, and Chief Executive Officer of Marinus.
Their ZTALMY franchise has experienced a steady growth curve, especially for treating CDKL5 deficiency disorder. ZTALMY also showed promising commercial performance with over 165 patients actively receiving the treatment at the end of 2023. As a result, the company projects U.S. ZTALMY net product revenue for 2024 between $32 and $34 million.
Marinus announced it had reached the enrollment target for interim analysis in the Phase 3 RAISE trial of intravenous ganaxolone, addressing refractory status epilepticus. This promising development is supported partially by the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) under contract number 75A50120C00159.
Additionally, Orion Corporation is preparing for the commercial launch of ZTALMY in select European countries by 2024, expanding Marinus Pharmaceuticals’ global market reach.
Financially, Marinus pharmaceuticals displayed strong health, with a cash balance of $150.3 million as of December 31, 2023. It reported $6.6 million and $19.6 million in net product revenues for the three and twelve months ended December 31, 2023, respectively, showing a substantial increase from the same periods in 2022.
The company also saw an increase in sales, general, and administrative (SG&A) expenses due to the launch of U.S. ZTALMY and increased headcount. Despite these expenditures, the company’s net losses were contained at $41.8 million and $141.4 million for the three and twelve months ended December 31, 2023, respectively.
Despite the challenges of the current economic climate, Marinus has confidently forecasted its cash resources will fund the company’s operating expenses, capital expenditure requirements, and maintain the necessary minimum cash balance into the fourth quarter of 2024.
Marinus Pharmaceuticals’ ambitious endeavors into research and development are amply demonstrated by their current trials. The company is working on a Phase 3 TrustTSC trial to investigate oral ganaxolone’s efficacy in treating tuberous sclerosis complex. The trial is 85% complete and is expected to finish by Q2 2024 with top-line data available by the end of that year.
In addition to these ongoing trials, the company is planning to initiate a proof-of-concept study using oral ganaxolone to treat a range of epileptic encephalopathies by the end of 2024, further bolstering its pipeline.
The company’s Annual Report on Form 10-K elaborates further on its business plans, operations, fiscal condition, and operating results for the fiscal year ended December 31, 2023. The report will be filed with the Securities and Exchange Commission on March 5, 2024.
This report is indicative of Marinus Pharmaceuticals’ determined focus on developing innovative solutions for life-threatening conditions and their commitment to improving patients’ quality of life across the globe. The company’s strategic moves place them in a strong position for future growth.
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