Marinus Pharmaceuticals Reports Preliminary Fourth Quarter and Full Year 2023 ZTALMY® Net Product Revenue and Provides Business Update
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The preliminary financial results for Marinus Pharmaceuticals indicate a steady increase in net product revenue for ZTALMY, with Q4 2023 revenues projected between $6.5 and $6.7 million and an overall annual revenue between $19.5 and $19.7 million. The projected revenue for the full year 2024 suggests a significant growth, with estimates ranging from $32 to $34 million. This revenue trajectory reflects an expanding market presence and growing adoption rate of ZTALMY in the treatment of seizure disorders. Investors should note the company's strong cash position, with $150.3 million in cash and short-term investments, providing a solid runway into Q4 2024. This financial stability is crucial for supporting ongoing clinical trials and potential commercial expansion.
However, the financial figures are preliminary and unaudited, which indicates a degree of uncertainty. Final figures could vary and investors should be prepared for potential adjustments following the completion of the audit. Additionally, the company's reliance on a single product for revenue generation could pose risks if market adoption slows or if competitive products enter the market. Diversification of the product portfolio could mitigate such risks in the long term.
The enrollment progress in Marinus Pharmaceuticals' Phase 3 clinical trials for ZTALMY is a positive indicator of the company's operational efficiency and the drug's potential impact on refractory seizure disorders. The RAISE trial for intravenous ganaxolone in refractory status epilepticus (RSE) and the TrustTSC trial in tuberous sclerosis complex are both nearing completion of enrollment, with over 90% and 70% of required patients enrolled, respectively. These trials are critical to the company's future, as positive results could lead to expanded indications for ganaxolone, potentially increasing its market size and revenue potential.
Moreover, the collaboration with BARDA for the RAISE trial underscores the potential importance of ganaxolone in addressing public health needs. The support from a government agency could enhance the credibility of the drug and facilitate a smoother regulatory pathway. However, the inherent risks of clinical trials, including the possibility of not meeting efficacy or safety endpoints, must be considered. The company's future financial performance and stock valuation are closely tied to the outcomes of these clinical trials.
The projected increase in net product revenue for ZTALMY in 2024 indicates that Marinus Pharmaceuticals is gaining traction in the epilepsy and rare disease market. This is likely due to a combination of strategic commercial initiatives and the unmet medical needs in the treatment of seizure disorders. The company's focus on this niche market could be advantageous, as specialized drugs often command higher prices and face less competition.
However, the market for seizure disorder treatments is highly specialized, requiring targeted marketing and sales efforts to reach the right healthcare providers and patient populations. The successful launch of ZTALMY in select European countries, in partnership with Orion Corporation, could be a key driver for international revenue growth. Expansion into global markets presents opportunities for increased revenue diversification, but also brings challenges related to regulatory approvals, market access and competition from established treatments. Close monitoring of the competitive landscape and regulatory developments will be essential for investors to assess the long-term potential of Marinus Pharmaceuticals.
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ZTALMY® (ganaxolone) Q4 2023 preliminary net product revenue of between
$6.5 $6.7 million $19.5 $19.7 million -
Projected full year 2024 U.S. ZTALMY net product revenue of between
$32 $34 million -
Over
90% of patients required for the interim analysis are now enrolled in the RAISE trial -
TrustTSC trial enrollment now over
70% ; enrollment completion anticipated by end of Q1 and topline data anticipated in Q3 2024 -
Cash runway projected into Q4 2024 with preliminary unaudited cash, cash equivalents and short-term investments of
$150.3 million
“Our commercial strategy and deep understanding of the epilepsy and rare disease space continues to drive increasing adoption of ZTALMY, establishing a strong foundation for the future of the franchise and positioning us to generate robust growth in the year ahead,” said Scott Braunstein, M.D., Chairman and Chief Executive Officer of Marinus. “We expect 2024 will be another pivotal year for Marinus with two Phase 3 data readouts anticipated, beginning with topline data from the RAISE trial of IV ganaxolone in refractory status epilepticus in the second quarter followed by the TrustTSC study readout in tuberous sclerosis complex in the third quarter. We have an opportunity to address significant unmet needs in patients with refractory seizure disorders and remain committed to developing potentially lifesaving treatments.”
ZTALMY®
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Continued to execute
U.S. commercial launch of ZTALMY® (ganaxolone) oral suspension CV, resulting in preliminary unaudited net product revenue of between$6.5 $6.7 million $19.5 $19.7 million - Continued growth in commercial patients with more than 165 patients active on therapy at the end of 2023
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Full year 2024 projected
U.S. ZTALMY net product revenues of between$32 $34 million - Orion Corporation continues to prepare for commercial launches of ZTALMY in select European countries in 2024
Pipeline Update
Status Epilepticus
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Over
90% of the 82 patients required for an interim analysis are now enrolled in the Phase 3 RAISE trial of intravenous (IV) ganaxolone in refractory status epilepticus (RSE)- Continue to expect enrollment for the interim analysis to conclude in the first quarter of 2024 with topline data anticipated in the second quarter of 2024, assuming pre-defined stopping criteria for the interim analysis are met
- To date, 26 patients with super refractory status epilepticus (SRSE) have been treated with IV ganaxolone under eINDs
Ganaxolone development in the RAISE trial is being funded in part by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response at the
Tuberous Sclerosis Complex
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Over
70% of the 128 patients required in the global Phase 3 TrustTSC trial of oral ganaxolone are now enrolled with expected enrollment completion by the end of Q1 2024; total blinded discontinuation rates to date remain below10% - Topline data anticipated in Q3 2024
Financial Update
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Preliminary unaudited cash, cash equivalents, and short-term investments of
$150.3 million $15 million
The preliminary fourth quarter and full-year 2023 net product revenue results and cash, cash equivalents, and short-term investments included in this release were calculated prior to the completion of an audit by the Company’s independent registered public accounting firm and are therefore subject to adjustment.
About Marinus Pharmaceuticals
Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. The Company first introduced FDA-approved prescription medication ZTALMY® (ganaxolone) oral suspension CV in the
Forward-Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Marinus, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may", "will", "expect", "anticipate", "estimate", "intend", "believe", and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements regarding our commercialization and marketing plans for ZTALMY; our net product revenue guidance; the potential benefits ZTALMY will provide for physicians and patients; statements regarding our expected clinical development plans, enrollment in our clinical trials, regulatory communications and submissions for ganaxolone, and the timing thereof; our expected data readouts; our expected cash runway; our expectations and beliefs regarding the FDA and EMA with respect to our product candidates; our financial projections; the potential safety and efficacy of ganaxolone, as well as its therapeutic potential in a number of indications; and other statements regarding the company's future operations, financial performance, financial position, prospects, objectives and other future events.
Forward-looking statements in this press release involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, unexpected market acceptance, payor coverage or future prescriptions and revenue generated by ZTALMY; unexpected actions by the FDA or other regulatory agencies with respect to our products; competitive conditions and unexpected adverse events or patient outcomes from being treated with ZTALMY, uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials; unanticipated costs and expenses; the company’s cash and cash equivalents may not be sufficient to support our operating plan for as long as anticipated; our ability to comply with the FDA’s requirement for additional post-marketing studies in the required time frames; the timing of regulatory filings for our other product candidates; clinical trial results may not support regulatory approval or further development in a specified indication or at all; actions or advice of the FDA or EMA may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional clinical trials; the size and growth potential of the markets for the company’s product candidates, and the company’s ability to service those markets; the company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; delays, interruptions or failures in the manufacture and supply of our product candidates; and the company’s ability to obtain additional funding to support its clinical development and commercial programs. This list is not exhaustive and these and other risks are described in our periodic reports, including our annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
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Investors
Jim DeNike
Senior Director, Investor Relations
Marinus Pharmaceuticals, Inc.
jdenike@marinuspharma.com
Media
Molly Cameron
Director, Corporate Communications & Investor Relations
Marinus Pharmaceuticals, Inc.
mcameron@marinuspharma.com
Source: Marinus Pharmaceuticals
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