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Marinus Pharmaceuticals Provides Business Update and Reports Third Quarter 2024 Financial Results

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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.

Positive
  • 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
Negative
  • 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 $8.5M Q3 ZTALMY revenue shows strong 56% YoY growth, the company faces significant headwinds. The failed Phase 3 trials in status epilepticus and tuberous sclerosis complex have forced a strategic pivot, leading to a 45% workforce reduction and suspension of clinical development programs. The balance sheet shows concerning trends with cash dropping to $42.2M from $150.3M YE2023 and stockholders' equity turning negative at -$66.7M. The exploration of strategic alternatives and engagement of Barclays signals potential M&A or restructuring ahead. Cash runway only extends to Q2 2025, creating urgency for strategic decisions.

The commercial performance of ZTALMY remains a bright spot, with over 200 active patients and narrowed FY2024 revenue guidance of $33-34M. The recent patent extension to 2042 for oral titration regimens adds valuable IP protection. However, the suspension of pipeline development significantly impacts future growth potential. The $98.7M net loss for the first nine months and negative stockholders' equity position weakens negotiating leverage for strategic alternatives. The upcoming FDA meeting in Q4 2024 regarding IV ganaxolone for RSE represents a critical milestone that could influence strategic options.

  • ZTALMY® (ganaxolone) Q3 2024 net product revenue of $8.5 million representing growth of 56% versus Q3 2023
  • Narrowing full year 2024 ZTALMY net product revenue guidance to $33 to $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 $42.2 million as of September 30, 2024

RADNOR, Pa.--(BUSINESS WIRE)-- Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today reported business highlights and financial results for the third quarter ended September 30, 2024.

“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 $8.5 million for the third quarter of 2024 representing 56% growth versus the third quarter of 2023.
  • Narrowing full year 2024 net product revenue guidance to $33 to $34 million from a range of $33 to $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 $33 and $34 million and combined selling, general and administrative (SG&A) and research and development (R&D) expenses in the range of approximately $135 to $138 million, including stock-based compensation expense of approximately $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 $42.2 million as of September 30, 2024, to fund the Company’s operating expenses and capital expenditure requirements into the second quarter of 2025. 

Financial Results

  • Recognized $8.5 million and $23.9 million in net product revenue for the three and nine months ended September 30, 2024, respectively, as compared to $5.4 million and $13.0 million for the same periods in the prior year, respectively.
  • Recognized $0.1 million and $0.3 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 $1.9 million and $10.8 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.
  • R&D expenses were $16.3 million and $61.3 million for the three and nine months ended September 30, 2024, respectively, as compared to $23.7 million and $73.0 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.
  • SG&A expenses were $12.6 million and $47.9 million for the three and nine months ended September 30, 2024, respectively, as compared to $14.9 million and $45.8 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.
  • The Company had net losses of $24.2 million and $98.7 million for the three and nine months ended September 30, 2024, respectively; cash used in operating activities decreased to $87.8 million for the nine months ended September 30, 2024, compared to $91.0 million for the same period a year ago.
  • At September 30, 2024, the Company had cash and cash equivalents of $42.2 million, compared to cash, cash equivalents and short-term investments of $150.3 million at December 31, 2023.

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,
2024
(unaudited)

 

December 31,
2023

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
September 30,

 

Six Months Ended
September 30,

 

 

2024
(Unaudited)

 

2023
(Unaudited)

 

2024
(Unaudited)

 

2023
(Unaudited)

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 U.S. in 2022. For more information, please visit www.marinuspharma.com and follow us on LinkedIn, X and Facebook.

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 Europe pursuant to the exclusive collaboration agreement; 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, the company’s cash and cash equivalents may not be sufficient to support its 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 size and growth potential of the markets for the company’s products, 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; the company’s ability to obtain additional funding to support its programs; and the company’s ability to protect its intellectual property. This list is not exhaustive and these and other risks are described in our periodic reports, including the annual report 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.

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

FAQ

What was Marinus Pharmaceuticals (MRNS) Q3 2024 revenue for ZTALMY?

ZTALMY net product revenue was $8.5 million in Q3 2024, representing 56% growth compared to Q3 2023.

What is MRNS's updated revenue guidance for ZTALMY in 2024?

Marinus narrowed its full-year 2024 ZTALMY net product revenue guidance to $33-34 million from the previous range of $33-35 million.

How much cash does Marinus Pharmaceuticals (MRNS) have as of Q3 2024?

Marinus reported cash and cash equivalents of $42.2 million as of September 30, 2024, expected to fund operations into Q2 2025.

What cost reduction measures did MRNS implement in Q4 2024?

Marinus implemented cost reductions including suspending further ganaxolone clinical development and a workforce reduction of approximately 45%.

Marinus Pharmaceuticals, Inc

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