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 second quarter ended June 30, 2024.
“Since launching ZTALMY in the U.S. two years ago, we have seen significant growth and adoption with strong revenue for the second quarter, underscoring the appreciation physicians, patients and caregivers have for ZTALMY and its role in the treatment of CDKL5 deficiency disorder,” said Scott Braunstein, M.D., Chairman and Chief Executive Officer of Marinus. “We continue to grow the brand globally with ZTALMY now approved in the U.S., EU, UK and China. We look forward to continuing to expand access to this important treatment option while generating revenue from markets outside the U.S.”
Dr. Braunstein continued, “Our proven commercial infrastructure and success in CDD provides us with a solid foundation to expand into TSC, which represents a significant unmet need in a larger refractory epilepsy population. With enrollment complete in the Phase 3 TrustTSC trial and data upcoming, we continue to make the appropriate investments and plan for a potential launch in the fall of 2025. We will be hosting an investor and analyst event on September 20th, where senior management and key opinion leaders will discuss the treatment landscape, market potential and commercial opportunity for ZTALMY in TSC.”
ZTALMY® (ganaxolone) Oral Suspension CV
- Generated net product revenue of $8.0 million for the second quarter of 2024 representing 87% growth versus the second quarter of 2023
- On track to achieve full year 2024 ZTALMY net product revenue guidance of between $33 and $35 million
- Continue to expand global access:
- Activated managed access programs for named patients in the Middle East and North Africa (MENA), Canada and Russia with ex-U.S. revenue expected in the third quarter of 2024
- In July, ZTALMY was approved in China for patients with CDKL5 deficiency disorder (CDD); Tenacia Biotechnology is anticipating commercial launch in early 2025
- Orion Corporation continues to prepare for commercial launches of ZTALMY in select European countries in the second half of 2024 with regulatory approvals secured in the European Union and United Kingdom for the CDD indication
Clinical Pipeline
Tuberous Sclerosis Complex
- Enrollment in the global Phase 3 TrustTSC trial of oral ganaxolone in tuberous sclerosis complex (TSC) is complete with last patient visit expected in September; topline data is on track for the first half of the fourth quarter of 2024
- Targeting submission of a supplemental New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in April 2025 with a request for priority review
- TrustTSC maintains a low discontinuation rate of less than 7% with greater than 85% of patients to date continuing to the open-label extension
- Launch planning and market access landscape assessment underway in preparation of anticipated commercial launch in the second half of 2025
Other Rare Genetic Epilepsies
- Expect to initiate a proof-of-concept study with ZTALMY to treat a range of developmental and epileptic encephalopathies, including Lennox-Gastaut syndrome, in the first half of 2025, pending the TSC topline data
- Targeting submission of an Investigational New Drug application for a novel oral ganaxolone prodrug in the fourth quarter of 2025
Status Epilepticus
- Announced topline results from the Phase 3 RAISE trial of intravenous (IV) ganaxolone in refractory status epilepticus
- Planning to submit a request for a Type C meeting with the FDA to discuss the RAISE trial results and next steps for the IV ganaxolone program
- Continue to offer IV ganaxolone for patients with super refractory status epilepticus under emergency investigational new drug applications with 31 patients treated to date
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
- On August 1, 2024, the Patent Trial and Appeal Board issued its final written decision in the post-grant review of Ovid Therapeutics’ U.S. Patent No. 11,395,817 for IV ganaxolone in the treatment of status epilepticus, determining that all remaining claims—claims 22 and 25-31—were unpatentable as obvious. The decision is publicly available on the Patent Office’s website here.
- In June 2024, Marinus restructured its agreements with Oaktree Capital Management, L.P. and Sagard Healthcare Partners. Under the restructuring, the $15 million minimum liquidity requirement was removed from both the Oaktree and Sagard agreements, and amortization payments due to Oaktree in 2024 have been reduced by 50%. In return, Marinus made a one-time principal payment of $15 million to Oaktree in the second quarter of 2024.
- Cost reduction plans initiated in the second quarter of 2024 are expected to reduce combined selling, general and administrative (SG&A) and R&D expenses by approximately 30% from $80.3 million in the first half of 2024 to between $55 and $60 million in the second half of 2024. The full on-going impact of cost savings is expected to be achieved in the third quarter of 2024.
- Full year 2024 guidance remains unchanged with projected ZTALMY net product revenue between $33 and $35 million and combined SG&A and R&D expenses in the range of approximately $135 to $140 million, including stock-based compensation expense of approximately $20 million.
- Through the execution of the cost reduction plans and restructured financing agreements, the Company expects that cash and cash equivalents of $64.7 million as of June 30, 2024, will be sufficient to fund the Company’s operating expenses and capital expenditure requirements into the second quarter of 2025.
- The Company continues to make investments to expand ZTALMY manufacturing capacity necessary for the global launch of the CDD indication and potential TSC expansion.
Financial Results
- Recognized $8.0 million and $15.5 million in net product revenue for the three and six months ended June 30, 2024, respectively, as compared to $4.2 million and $7.6 million for the same periods in the prior year, respectively.
- Recognized $0.1 million and $0.2 million in Biomedical Advanced Research and Development Authority (BARDA) federal contract revenue for the three and six months ended June 30, 2024, respectively, as compared to $1.8 million and $8.9 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 base period funding in the fourth quarter of 2023.
- Research and development (R&D) expenses were $20.9 million and $45.0 million for the three and six months ended June 30, 2024, respectively, as compared to $21.4 million and $49.3 million for the same periods in the prior year, respectively. The three month decrease was due primarily to reduced personnel costs in 2024, partially offset by increased costs associated with the RAISE Trial. The six month decrease was also driven by costs associated with start-up of the API onshoring effort in the first quarter of 2023.
- Selling, general and administrative (SG&A) expenses were $16.7 million and $35.3 million for the three and six months ended June 30, 2024, respectively, as compared to $15.7 million and $30.9 million for the same periods in the prior year, respectively; the primary drivers of the increases were increased commercial spending and headcount costs in 2024.
- Restructuring costs were $2.0 million for the three months ended June 30, 2024, resulting from cost saving initiatives implemented in the second quarter of 2024.
- The Company had net losses of $35.8 million and $74.5 million for the three and six months ended June 30, 2024, respectively; cash used in operating activities increased to $68.3 million for the six months ended June 30, 2024, compared to $65.8 million for the same period a year ago.
- At June 30, 2024, the Company had cash and cash equivalents of $64.7 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 June 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.
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Selected Financial Data (in thousands, except share and per share amounts) |
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|
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June 30, |
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December 31, |
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ASSETS |
|
|
|
|
|
|
Cash and cash equivalents |
$ |
64,676 |
|
$ |
120,572 |
|
Short-term investments |
|
– |
|
|
29,716 |
|
Other assets |
|
22,407 |
|
|
20,620 |
|
Total assets |
$ |
87,083 |
|
$ |
170,908 |
|
LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY |
|
|
|
|
|
|
Current liabilities |
$ |
35,867 |
|
$ |
40,624 |
|
Long term debt, net |
|
45,075 |
|
|
61,423 |
|
Revenue interest financing payable, net |
|
35,431 |
|
|
33,766 |
|
Other long-term liabilities |
|
18,055 |
|
|
18,330 |
|
Total liabilities |
|
134,428 |
|
|
154,143 |
|
Total stockholders’ (deficit) equity |
|
(47,345) |
|
|
16,765 |
|
Total liabilities and stockholders’ (deficit) equity |
$ |
87,083 |
|
$ |
170,908 |
|
|
|
Three Months Ended |
|
Six Months Ended |
||||||||||||
|
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
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Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Product revenue, net |
|
$ |
7,951 |
|
|
$ |
4,249 |
|
|
$ |
15,460 |
|
|
$ |
7,581 |
|
|
Federal contract revenue |
|
|
87 |
|
|
|
1,814 |
|
|
|
239 |
|
|
|
8,862 |
|
|
Collaboration revenue |
|
|
18 |
|
|
|
18 |
|
|
|
36 |
|
|
|
18 |
|
|
Total revenue |
|
|
8,056 |
|
|
|
6,081 |
|
|
|
15,735 |
|
|
|
16,461 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
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Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Research and development |
|
|
20,897 |
|
|
|
21,412 |
|
|
|
45,015 |
|
|
|
49,345 |
|
|
Selling, general and administrative |
|
|
16,710 |
|
|
|
15,722 |
|
|
|
35,336 |
|
|
|
30,926 |
|
|
Restructuring Costs |
|
|
1,950 |
|
|
|
– |
|
|
|
1,950 |
|
|
|
– |
|
|
Cost of product revenue |
|
|
735 |
|
|
|
386 |
|
|
|
1,491 |
|
|
|
592 |
|
|
Total expenses: |
|
|
40,292 |
|
|
|
37,520 |
|
|
|
83,792 |
|
|
|
80,863 |
|
|
Loss from operations |
|
|
(32,236 |
) |
|
|
(31,439 |
) |
|
|
(68,057 |
) |
|
|
(64,402 |
) |
|
Interest income |
|
|
1,109 |
|
|
|
2,128 |
|
|
|
2,571 |
|
|
|
4,471 |
|
|
Interest expense |
|
|
(4,617 |
) |
|
|
(4,208 |
) |
|
|
(8,963 |
) |
|
|
(8,355 |
) |
|
Other (expense) income, net |
|
|
(84 |
) |
|
|
47 |
|
|
|
(48 |
) |
|
|
84 |
|
|
Loss before income taxes |
|
|
(35,828 |
) |
|
|
(33,472 |
) |
|
|
(74,497 |
) |
|
|
(68,202 |
) |
|
Benefit for income taxes |
|
|
– |
|
|
|
1,538 |
|
|
|
– |
|
|
|
1,538 |
|
|
Net loss applicable to common shareholders |
|
$ |
(35,828 |
) |
|
$ |
(31,934 |
) |
|
$ |
(74,497 |
) |
|
$ |
(66,664 |
) |
|
Per share information: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Net loss per share of common stock—basic and diluted |
|
$ |
(0.63 |
) |
|
$ |
(0.61 |
) |
|
$ |
(1.31 |
) |
|
$ |
(1.28 |
) |
|
Basic and diluted weighted average shares outstanding |
|
|
57,064,095 |
|
|
|
52,551,918 |
|
|
|
56,957,953 |
|
|
|
52,162,962 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Other comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Unrealized (loss) gain on available-for-sale securities |
|
|
– |
|
|
|
(188 |
) |
|
|
20 |
|
|
|
(114 |
) |
|
Total comprehensive loss |
|
$ |
(35,828 |
) |
|
$ |
(32,122 |
) |
|
$ |
(74,477 |
) |
|
$ |
(66,778 |
) |
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.
