Marinus Pharmaceuticals Reports Preliminary Fourth Quarter and Full Year 2023 ZTALMY® Net Product Revenue and Provides Business Update
04 Janvier 2024 - 1:01PM
Business Wire
- ZTALMY® (ganaxolone) Q4 2023 preliminary net product revenue of
between $6.5 and $6.7 million; full year 2023 preliminary net
product revenue of between $19.5 and $19.7 million
- Projected full year 2024 U.S. ZTALMY net product revenue of
between $32 and $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
as of December 31, 2023
Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical
company dedicated to the development of innovative therapeutics to
treat seizure disorders, today reported business highlights and
preliminary U.S. ZTALMY® net product revenue for the fourth quarter
and year ended December 31, 2023.
“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®
- Continued to execute U.S. commercial launch of ZTALMY®
(ganaxolone) oral suspension CV, resulting in preliminary unaudited
net product revenue of between $6.5 and $6.7 million for the fourth
quarter of 2023 and between $19.5 and $19.7 million for the fiscal
year ended December 31, 2023
- Continued growth in commercial patients with more than 165
patients active on therapy at the end of 2023
- Full year 2024 projected U.S. ZTALMY net product revenues of
between $32 and $34 million
- Orion Corporation continues to prepare for commercial launches
of ZTALMY in select European countries in 2024
Pipeline Update
Status Epilepticus
- 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 U.S. Department of Health and Human Services, under
contract number 75A50120C00159.
Tuberous Sclerosis Complex
- 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 below 10%
- Topline data anticipated in Q3 2024
Financial Update
- Preliminary unaudited cash, cash equivalents, and short-term
investments of $150.3 million as of December 31, 2023; expected to
fund the Company’s operating expenses, capital expenditure
requirements, and maintain the minimum cash balance of $15 million
required under the Company’s debt facility into the fourth quarter
of 2024
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 U.S. in 2022 and
continues to invest in the potential of ganaxolone in IV and oral
formulations to maximize therapeutic reach for adult and pediatric
patients in acute and chronic care settings. For more information
about Marinus visit www.marinuspharma.com.
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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version on businesswire.com: https://www.businesswire.com/news/home/20240104049645/en/
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
Marinus Pharmaceuticals (NASDAQ:MRNS)
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