Marinus Pharmaceuticals Provides Business Update and Reports Third Quarter 2024 Financial Results
Marinus Pharmaceuticals (MRNS) reported Q3 2024 financial results with ZTALMY net product revenue of $8.5 million, showing 56% growth versus Q3 2023. The company narrowed its 2024 ZTALMY revenue guidance to $33-34 million. Following unsuccessful Phase 3 trial results, Marinus has suspended further ganaxolone clinical development and implemented cost reductions, including a 45% workforce reduction. The company reported cash and cash equivalents of $42.2 million as of September 30, 2024, expected to fund operations into Q2 2025. Marinus has initiated a process to explore strategic alternatives to maximize stockholder value while supporting ZTALMY's commercial growth.
Marinus Pharmaceuticals (MRNS) ha riportato i risultati finanziari del terzo trimestre del 2024, con entrate nette da prodotto ZTALMY di 8,5 milioni di dollari, mostrando una crescita del 56% rispetto al terzo trimestre del 2023. L'azienda ha ristretto la previsione di entrate per il 2024 da ZTALMY a 33-34 milioni di dollari. A seguito di risultati non soddisfacenti della sperimentazione di Fase 3, Marinus ha sospeso ulteriore sviluppo clinico di ganaxolone e ha implementato riduzioni dei costi, inclusa una riduzione del 45% della forza lavoro. L'azienda ha riportato liquidità e equivalenti di liquidità di 42,2 milioni di dollari al 30 settembre 2024, previsti per finanziare le operazioni fino al secondo trimestre del 2025. Marinus ha avviato un processo per esplorare alternative strategiche al fine di massimizzare il valore per gli azionisti, supportando nel contempo la crescita commerciale di ZTALMY.
Marinus Pharmaceuticals (MRNS) informó sobre los resultados financieros del tercer trimestre de 2024, con ingresos netos por el producto ZTALMY de 8.5 millones de dólares, lo que representa un crecimiento del 56% en comparación con el tercer trimestre de 2023. La compañía ha ajustado su orientación de ingresos para ZTALMY 2024 a 33-34 millones de dólares. Tras resultados no exitosos en los ensayos de Fase 3, Marinus ha suspendido el desarrollo clínico de ganaxolone y ha implementado reducciones de costos, incluida una reducción del 45% de la plantilla. La empresa reportó efectivo y equivalentes de efectivo de 42.2 millones de dólares al 30 de septiembre de 2024, que se espera financiará las operaciones hasta el segundo trimestre de 2025. Marinus ha iniciado un proceso para explorar alternativas estratégicas para maximizar el valor para los accionistas mientras apoya el crecimiento comercial de ZTALMY.
마리누스 제약 (MRNS)는 2024년 3분기 재무 결과를 보고했으며, ZTALMY의 순제품 수익이 850만 달러로 2023년 3분기 대비 56% 성장했습니다. 회사는 2024년 ZTALMY 수익 전망을 3,300만 - 3,400만 달러로 조정했습니다. 3상 시험 결과가 불발되면서 마리누스는 ganaxolone의 추가 임상 개발을 중단하고, 45%의 인력 감축을 포함한 비용 절감을 시행했습니다. 회사는 2024년 9월 30일 기준 현금 및 현금성 자산이 4,220만 달러라고 보고했으며, 이는 2025년 2분기까지 운영을 지원할 것으로 예상됩니다. 마리누스는 주주 가치를 극대화하고 ZTALMY의 상업적 성장을 지원하기 위해 전략적 대안을 탐색하는 프로세스를 시작했습니다.
Marinus Pharmaceuticals (MRNS) a annoncé les résultats financiers du troisième trimestre 2024, avec des revenus nets de produit ZTALMY de 8,5 millions de dollars, enregistrant une croissance de 56 % par rapport au troisième trimestre 2023. La société a révisé ses prévisions de revenus pour ZTALMY 2024 entre 33 et 34 millions de dollars. Suite à des résultats de phase 3 non concluants, Marinus a suspendu le développement clinique supplémentaire de ganaxolone et mis en œuvre des réductions de coûts, y compris une réduction de 45 % de son personnel. La société a rapporté liquidités et équivalents de liquidités de 42,2 millions de dollars au 30 septembre 2024, prévus pour financer ses opérations jusqu'au deuxième trimestre 2025. Marinus a lancé un processus d'exploration d'alternatives stratégiques pour maximiser la valeur pour les actionnaires tout en soutenant la croissance commerciale de ZTALMY.
Marinus Pharmaceuticals (MRNS) hat die finanziellen Ergebnisse für das 3. Quartal 2024 veröffentlicht, mit netto Produktumsatz von ZTALMY in Höhe von 8,5 Millionen US-Dollar, was einem Wachstum von 56% im Vergleich zum 3. Quartal 2023 entspricht. Das Unternehmen hat seine Umsatzprognose für ZTALMY 2024 auf 33-34 Millionen US-Dollar eingegrenzt. Nach den erfolglosen Ergebnissen der Phase-3-Studie hat Marinus die weitere klinische Entwicklung von Ganaxolon eingestellt und Kostensenkungsmaßnahmen umgesetzt, einschließlich einer Reduzierung der Belegschaft um 45%. Das Unternehmen meldete liquide Mittel und Äquivalente in Höhe von 42,2 Millionen US-Dollar zum 30. September 2024, die voraussichtlich den Betrieb bis zum 2. Quartal 2025 finanzieren werden. Marinus hat einen Prozess eingeleitet, um strategische Alternativen zur Maximierung des Aktionärswertes zu prüfen und gleichzeitig das kommerzielle Wachstum von ZTALMY zu unterstützen.
- ZTALMY Q3 revenue grew 56% year-over-year to $8.5 million
- New U.S. patent issued for ZTALMY oral titration regimens, extending protection until 2042
- Over 200 patients active on ZTALMY therapy
- Phase 3 trials in status epilepticus and tuberous sclerosis complex failed to meet statistical significance
- 45% workforce reduction implemented
- Cash position declined from $150.3M to $42.2M since December 2023
- Net loss of $24.2M in Q3 2024
- Suspension of further ganaxolone clinical development
- Company exploring strategic alternatives, indicating potential sale or restructuring
Insights
A challenging quarter for Marinus with mixed signals. While
The commercial performance of ZTALMY remains a bright spot, with over 200 active patients and narrowed FY2024 revenue guidance of
-
ZTALMY® (ganaxolone) Q3 2024 net product revenue of
representing growth of$8.5 million 56% versus Q3 2023 -
Narrowing full year 2024 ZTALMY net product revenue guidance to
to$33 $34 million - Reported results from Phase 3 TrustTSC trial and commenced process to explore strategic alternatives
- Marinus continues to support the commercial growth of ZTALMY; further ganaxolone clinical development has been suspended
- Scheduled to meet with FDA Q4 2024 to discuss a potential path forward for IV ganaxolone in refractory status epilepticus
-
Cost reduction plans implemented with cash runway expected into Q2 2025; cash and cash equivalents of
as of September 30, 2024$42.2 million
“We are pleased to see continued commercial growth of ZTALMY with more than 200 patients active on therapy and a steady increase in demand,” said Scott Braunstein, M.D., Chairman and Chief Executive Officer of Marinus. “In 2024, our Phase 3 data in status epilepticus and tuberous sclerosis complex showed meaningful clinical activity in certain refractory patients, however, the trials did not meet the thresholds for statistical significance. Given this outcome, we have made the difficult decision to explore strategic alternatives with the goal of maximizing stockholder value while supporting the growth of ZTALMY for patients with CDKL5 deficiency disorder (CDD).”
Dr. Braunstein continued, “I extend my deepest gratitude to our dedicated employees for their significant contributions to our work, and to the patients and clinicians who participated in our trials. We are proud to have delivered the first-and-only FDA-approved treatment for patients with seizures associated with CDD and hope that our research will serve as a foundation for future innovations in areas of high unmet need.”
ZTALMY® (ganaxolone) Oral Suspension CV
-
Generated net product revenue of
for the third quarter of 2024 representing$8.5 million 56% growth versus the third quarter of 2023. -
Narrowing full year 2024 net product revenue guidance to
to$33 from a range of$34 million to$33 .$35 million -
Announced issuance of new
U.S. patent for ZTALMY oral titration regimens covering the treatment of a range of epilepsies, expiring September 2042.
Clinical Updates
-
The
U.S. Food and Drug Administration (FDA) granted Marinus a Type C meeting, scheduled for the fourth quarter of 2024, to discuss a potential path forward for intravenous (IV) ganaxolone in refractory status epilepticus (RSE). - Presented data from the Phase 3 RAISE trial evaluating IV ganaxolone for the treatment of RSE at the Neurocritical Care Society Annual Meeting in October 2024.
- Announced topline results from the Phase 3 TrustTSC trial of oral ganaxolone in tuberous sclerosis complex (TSC) whereby the trial did not achieve statistical significance in the primary endpoint.
- Marinus will continue to support the commercial growth of ZTALMY and activities required by the FDA and European Medicines Agency specific to post-approval commitments related to the CDD indication.
Ganaxolone development in the RAISE trial has been supported in part by the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under contract number 75A50120C00159.
General Business and Financial Update
- Marinus has commenced a process to explore strategic alternatives with the goal of maximizing value for its stockholders and has engaged Barclays as an advisor to assist in reviewing its strategic alternatives.
-
Full year 2024 guidance has been narrowed with projected ZTALMY net product revenue between
and$33 and combined selling, general and administrative (SG&A) and research and development (R&D) expenses in the range of approximately$34 million to$135 , including stock-based compensation expense of approximately$138 million .$20 million -
Cost reduction activities were initiated in the fourth quarter of 2024, including suspending further ganaxolone clinical development and a workforce reduction of approximately
45% . -
Through the execution of the cost reduction plans, the Company had cash and cash equivalents of
as of September 30, 2024, to fund the Company’s operating expenses and capital expenditure requirements into the second quarter of 2025.$42.2 million
Financial Results
-
Recognized
and$8.5 million in net product revenue for the three and nine months ended September 30, 2024, respectively, as compared to$23.9 million and$5.4 million for the same periods in the prior year, respectively.$13.0 million -
Recognized
and$0.1 million in Biomedical Advanced Research and Development Authority (BARDA) federal contract revenue for the three and nine months ended September 30, 2024, respectively, as compared to$0.3 million and$1.9 million for the same periods in the prior year, respectively. The decrease was primarily driven by activity associated with the start-up of the API onshoring initiative in the first quarter of 2023 and completion of the BARDA base period funding in the fourth quarter of 2023.$10.8 million -
R&D expenses were
and$16.3 million for the three and nine months ended September 30, 2024, respectively, as compared to$61.3 million and$23.7 million for the same periods in the prior year, respectively. The reduction was due primarily to reduced costs in 2024 associated with the RAISE trial completion and costs associated with start-up of the API onshoring effort in the first quarter of 2023.$73.0 million -
SG&A expenses were
and$12.6 million for the three and nine months ended September 30, 2024, respectively, as compared to$47.9 million and$14.9 million for the same periods in the prior year, respectively. The primary drivers of the decrease for the three month period were decreased personnel and consulting expenses, while the drivers of the increase for the nine month period were increased stock-based compensation expense and commercial expense.$45.8 million -
The Company had net losses of
and$24.2 million for the three and nine months ended September 30, 2024, respectively; cash used in operating activities decreased to$98.7 million for the nine months ended September 30, 2024, compared to$87.8 million for the same period a year ago.$91.0 million -
At September 30, 2024, the Company had cash and cash equivalents of
, compared to cash, cash equivalents and short-term investments of$42.2 million at December 31, 2023.$150.3 million
Readers are referred to, and encouraged to read in its entirety, the Company’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2024, to be filed with the Securities and Exchange Commission, which includes further detail on the Company’s business plans, operations, financial condition, and results of operations.
Selected Financial Data (in thousands, except share and per share amounts)
|
September 30,
|
|
December 31,
|
||
ASSETS |
|
|
|
|
|
Cash and cash equivalents |
$ |
42,184 |
|
$ |
120,572 |
Short-term investments |
|
- |
|
|
29,716 |
Other assets |
|
21,440 |
|
|
20,620 |
Total assets |
$ |
63,624 |
|
$ |
170,908 |
LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY |
|
|
|
|
|
Current liabilities |
$ |
34,504 |
|
$ |
40,624 |
Long term debt, net |
|
41,713 |
|
|
61,423 |
Revenue interest financing payable, net |
|
36,039 |
|
|
33,766 |
Other long-term liabilities |
|
18,108 |
|
|
18,330 |
Total liabilities |
|
130,364 |
|
|
154,143 |
Total stockholders’ (deficit) equity |
|
(66,740) |
|
|
16,765 |
Total liabilities and stockholders’ (deficit) equity |
$ |
63,624 |
|
$ |
170,908 |
|
|
Three Months Ended
|
|
Six Months Ended
|
||||||||||||
|
|
2024
|
|
2023
|
|
2024
|
|
2023
|
||||||||
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Product revenue, net |
|
$ |
8,468 |
|
|
$ |
5,429 |
|
|
$ |
23,928 |
|
|
$ |
13,010 |
|
Federal contract revenue |
|
|
56 |
|
|
|
1,891 |
|
|
|
295 |
|
|
|
10,753 |
|
Collaboration revenue |
|
|
17 |
|
|
|
18 |
|
|
|
53 |
|
|
|
36 |
|
Total revenue |
|
|
8,541 |
|
|
|
7,338 |
|
|
|
24,276 |
|
|
|
23,799 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
16,334 |
|
|
|
23,661 |
|
|
|
61,349 |
|
|
|
73,006 |
|
Selling, general and administrative |
|
|
12,573 |
|
|
|
14,868 |
|
|
|
47,909 |
|
|
|
45,794 |
|
Restructuring Costs |
|
|
- |
|
|
|
- |
|
|
|
1,950 |
|
|
|
- |
|
Cost of product revenue |
|
|
714 |
|
|
|
455 |
|
|
|
2,205 |
|
|
|
1,047 |
|
Total expenses: |
|
|
29,621 |
|
|
|
38,984 |
|
|
|
113,413 |
|
|
|
119,847 |
|
Loss from operations |
|
|
(21,080 |
) |
|
|
(31,646 |
) |
|
|
(89,137 |
) |
|
|
(96,048 |
) |
Interest income |
|
|
598 |
|
|
|
1,895 |
|
|
|
3,169 |
|
|
|
6,366 |
|
Interest expense |
|
|
(3,843 |
) |
|
|
(4,242 |
) |
|
|
(12,806 |
) |
|
|
(12,597 |
) |
Other income, net |
|
|
100 |
|
|
|
1,021 |
|
|
|
52 |
|
|
|
1,105 |
|
Loss before income taxes |
|
|
(24,225 |
) |
|
|
(32,972 |
) |
|
|
(98,722 |
) |
|
|
(101,174 |
) |
Benefit for income taxes |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,538 |
|
Net loss applicable to common shareholders |
|
$ |
(24,225 |
) |
|
$ |
(32,972 |
) |
|
$ |
(98,722 |
) |
|
$ |
(99,636 |
) |
Per share information: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share of common stock—basic and diluted |
|
$ |
(0.42 |
) |
|
$ |
(0.61 |
) |
|
$ |
(1.73 |
) |
|
$ |
(1.89 |
) |
Basic and diluted weighted average shares outstanding |
|
|
57,229,229 |
|
|
|
53,920,109 |
|
|
|
57,049,038 |
|
|
|
52,755,114 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Unrealized gain (loss) on available-for-sale securities |
|
|
- |
|
|
|
43 |
|
|
|
20 |
|
|
|
(71 |
) |
Total comprehensive loss |
|
$ |
(24,225 |
) |
|
$ |
(32,929 |
) |
|
$ |
(98,702 |
) |
|
$ |
(99,707 |
) |
About Marinus Pharmaceuticals
Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. The Company’s product, ZTALMY® (ganaxolone) oral suspension CV, is an FDA-approved prescription medication introduced 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, our expectations regarding the review and exploration of strategic alternatives and their potential impact on stockholder value; our expectations regarding the future of the company’s operations; our net product revenue and other financial guidance and projections; statements regarding our expected clinical development plans, enrollment in our clinical trials, and regulatory communications, and the timing thereof; our expected cash runway; our expectations and beliefs regarding the FDA and EMA with respect to our product candidates; our expectations regarding our cost reduction plans; the potential safety and efficacy of ganaxolone; and other statements regarding the company's future operations, financial performance, financial position, prospects, objectives and other future event.
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, the risk that exploration of strategic alternatives may not result in any definitive transaction or enhance stockholder value and may create a distraction or uncertainty that may adversely affect our operating results, business, or investor perceptions; uncertainties regarding future costs and expenses; Marinus’ ability to continue as a going concern; Marinus’ ability to maintain compliance with its debt covenants and risks and uncertainties regarding the ability to do; unexpected market acceptance, payor coverage or future prescriptions and revenue generated by ZTALMY; the pricing and reimbursement process can be time consuming and may delay commercialization of ZTALMY in one or more European countries; our dependence on Orion to commercialize ZTALMY in
View source version on businesswire.com: https://www.businesswire.com/news/home/20241112598483/en/
Company Contacts
Investors
Sonya Weigle
Chief People and Investor Relations Officer
Marinus Pharmaceuticals, Inc.
sweigle@marinuspharma.com
Media
Molly Cameron
Director, Corporate Communications & Investor Relations
Marinus Pharmaceuticals, Inc.
mcameron@marinuspharma.com
Source: Marinus Pharmaceuticals
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