Marinus Pharmaceuticals Provides Business Update and Reports Third Quarter 2022 Financial Results

08 November 2022

“I’m incredibly proud of the progress the Marinus team has made to position the organization for success as we enter our next stage of growth as a commercial-stage company,” said Scott Braunstein, M.D., Chief Executive Officer of Marinus. “The strong U.S. launch of ZTALMY coupled with two important recent transactions—the sale of the priority review voucher and the revenue interest financing—are projected to extend our cash runway into 2024 and allow us to continue to focus on executing beyond our two anticipated Phase 3 trial data readouts. We believe we are poised to execute on our goals and expand our reach to additional patients suffering from rare forms of epilepsy.”

ZTALMY ®

Clinical Pipeline

Status Epilepticus

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 (TSC)

CDKL5 Deficiency Disorder (CDD)

Second Generation Product Development

Financial and Business Updates

Financial Results (preliminary)

Selected Financial Data (in thousands, except share and per share amounts)

September 30,

December 31,

2022

2021

ASSETS

Cash and cash equivalents

$

168,249

$

122,927

Other assets

16,592

13,913

Total assets

$

184,841

$

136,840

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities

$

21,050

$

40,566

Long Term Debt, Net

70,780

40,809

Other long-term liabilities

11,007

1,979

Total liabilities

102,837

83,354

Total stockholders’ equity

82,004

53,486

Total liabilities and stockholders’ equity

$

184,841

$

136,840

Three Months Ended September 30,

Nine Months Ended September 30,

2022

2021

2022

2021

Revenue:

Product revenue, net

$

555

$

$

555

$

Federal contract revenue

1,785

1,127

5,088

4,838

Collaboration revenue

8,987

12,673

8,987

Total revenue

2,340

10,114

18,316

13,825

Expenses:

Research and development

19,002

18,353

58,488

55,506

Selling, general and administrative

13,389

9,452

42,187

26,656

Cost of product revenue

48

48

Cost of collaboration revenue

1,478

1,478

Cost of IP license fee

1,169

Total expenses:

32,439

29,283

101,892

83,640

Loss from operations

(30,099

)

(19,169

)

(83,576

)

(69,815

)

Interest income

514

17

610

57

Interest expense

(2,634

)

(678

)

(6,982

)

(1,029

)

Gain from sale of priority review voucher, net

107,375

107,375

Other income (expense), net

(114

)

323

(1,179

)

316

Income (loss) before income taxes

75,042

(19,507

)

16,248

(70,471

)

Provision for income taxes

(1,752

)

(1,752

)

Net income (loss) and comprehensive income (loss)

$

73,290

$

(19,507

)

$

14,496

$

(70,471

)

Net income (loss) applicable to common shareholders

$

71,634

$

(19,507

)

$

14,160

$

(70,471

)

Per share information:

Net income (loss) per share of common stock—basic

$

1.93

$

(0.53

)

$

0.38

$

(1.92

)

Net income (loss) per share of common stock—diluted

$

1.89

$

(0.53

)

$

0.37

$

(1.92

)

Basic weighted average shares outstanding

37,202,269

36,744,591

37,084,060

36,667,472

Diluted weighted average shares outstanding

37,910,511

36,744,591

38,393,754

36,667,472

Conference Call Information

Tuesday, November 8, at 8:30 a.m. ET
Domestic: (888) 550-5280
International: (646) 960-0813
Webcast Link: https://events.q4inc.com/attendee/163157006
Conference ID: 2696394

About Marinus Pharmaceuticals

Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. The Company’s commercial product, ZTALMY® (ganaxolone) oral suspension CV, has been approved by the U.S. FDA for the treatment of seizures associated with CDKL5 deficiency disorder in patients two years of age and older. The potential of ganaxolone is also being studied in other seizure disorders, including in Phase 3 trials in tuberous sclerosis complex and refractory status epilepticus. Ganaxolone is a neuroactive steroid GABAA receptor modulator that acts on a well-characterized target in the brain known to have anti-seizure effects. It is being developed in IV and oral formulations to maximize therapeutic reach for adult and pediatric patients in acute and chronic care settings. For more information 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; the potential benefits ZTALMY will provide for physicians and patients; our expectations regarding the ZTALMY One program; statements regarding our expected clinical development plans, enrollment in our clinical trials, regulatory communications and submissions for ganaxolone, and the timing thereof; our plans with respect to the use of the proceeds from the PRV sale and the Sagard agreement; our expected cash runway; our expectations regarding BARDA funding; our expectations and beliefs regarding the FDA and EMA with respect to our product candidates; our expectations regarding the development of new formulations and prodrug candidates; our expectation regarding the impact of the COVID-19 pandemic on our business and clinical development plans; 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 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, unexpected results or delays in the commercial launch of ZTALMY, including any potential delays caused by the current COVID-19 global pandemic; 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 varying interpretation of clinical data; 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; the potential that regulatory authorities, including the FDA and EMA, may not grant or may delay approval for our product candidates; early clinical trials may not be indicative of the results in later clinical trials; 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; our ability to obtain and maintain regulatory approval for our product candidate; our ability to develop new formulations of ganaxolone or prodrugs; our ability to obtain, maintain, protect and defend intellectual property for our product candidates; the potential negative impact of third party patents on our or our collaborators’ ability to commercialize ganaxolone; delays, interruptions or failures in the manufacture and supply of our product candidate; 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 cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the company’s ability to obtain additional funding to support its clinical development and commercial programs; the potential for our ex-US partners to breach their obligations under their respective agreements with us or terminate such agreements in accordance with their respective terms; the risk that drug product quality requirements may not support continued clinical investigation of our product candidates and result in delays or termination of such clinical studies and product approvals; the effect of the COVID-19 pandemic on our business, the medical community, regulators and the global economy; and the availability or potential availability of alternative products or treatments for conditions targeted by us that could affect the availability or commercial potential of our product candidate. 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.

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