Marinus Pharmaceuticals(MRNS)

Search documents
Marinus Pharmaceuticals(MRNS) - 2023 Q4 - Annual Results
2024-03-05 21:05
Exhibit 99.1 "We are thrilled to announce we have exceeded the enrollment threshold required to conduct an interim analysis in the Phase 3 RAISE trial in refractory status epilepticus, a life-threatening condition," said Scott Braunstein, M.D., Chairman and Chief Executive Officer of Marinus. "With over 90 patients now randomized following several months of increasingly strong enrollment trends, we are on track to announce topline data in the second quarter, assuming efficacy criteria for the interim analys ...
Marinus Pharmaceuticals(MRNS) - 2023 Q3 - Quarterly Report
2023-11-07 12:31
Revenue and Sales Performance - ZTALMY (ganaxolone) generated net product revenue of $5.4 million and $13.0 million for the three and nine months ended September 30, 2023, respectively[148]. - ZTALMY recorded net sales of $5.4 million and $13.0 million for the three and nine months ended September 30, 2023, respectively, compared to $0.6 million for both periods in 2022[240]. - Federal contract revenue increased to $1.9 million and $10.8 million for the three and nine months ended September 30, 2023, up from $1.8 million and $5.1 million in 2022, primarily due to ongoing validation of a new third-party supplier[241]. - Collaboration revenue was less than $0.1 million for the three and nine months ended September 30, 2023, a significant decrease from $12.7 million in the same period of 2022[244]. Clinical Trials and Regulatory Approvals - The European Commission granted marketing authorization for ZTALMY for the adjunctive treatment of seizures associated with CDD in patients aged 2 to 17 years on July 28, 2023[148]. - In a Phase 3 trial, patients treated with ZTALMY experienced a median 30.7% reduction in major motor seizure frequency compared to a 6.9% reduction in the placebo group, achieving statistical significance (p=0.0036)[152]. - The company expects interim analysis with top-line data readout for the RAISE trial to be available in the second quarter of 2024[146]. - The RAISE trial is designed to enroll approximately 124 patients, with an interim analysis expected in Q1 2024 and topline data anticipated in Q2 2024[173]. - The RAISE II trial is planned to initiate in Q4 2023, targeting 70 patients who have failed first-line benzodiazepine treatment[177]. - The FDA awarded a Rare Pediatric Disease Priority Review Voucher for ganaxolone, which was monetized for $110.0 million in cash in August 2022[150]. - The FDA granted orphan drug designation for ganaxolone for the treatment of Lennox-Gastaut Syndrome (LGS) in March 2023[196]. - Several post-marketing requirements for ZTALMY include carcinogenicity studies and a juvenile animal toxicity study, expected to be completed within the requested FDA timeframe[166]. Financial Performance and Expenses - The company incurred net losses of $33.0 million and $99.6 million for the three and nine months ended September 30, 2023, respectively, with an accumulated deficit of $530.2 million as of the same date[200]. - Research and development expenses totaled $23.7 million for the three months and $73.0 million for the nine months ended September 30, 2023, compared to $19.0 million and $58.5 million in 2022, driven by increased clinical trial activities[245]. - Selling, general and administrative expenses increased to $14.9 million and $45.8 million for the three and nine months ended September 30, 2023, compared to $13.4 million and $42.2 million in 2022[248]. - Interest income rose to $1.9 million and $6.4 million for the three and nine months ended September 30, 2023, compared to $0.5 million and $0.6 million in 2022, due to increased cash and investment yields[249]. - Interest expense increased to $4.2 million and $12.6 million for the three and nine months ended September 30, 2023, compared to $2.6 million and $7.0 million in 2022, reflecting higher debt-related costs[250]. - The company incurred a net loss of $99.6 million for the nine months ended September 30, 2023, following a net income of $14.5 million in the same period of 2022 due to a one-time gain from the sale of PRV[252]. - Cash used in operating activities was $91.0 million for both the nine months ended September 30, 2023 and 2022, indicating consistent cash flow challenges[252]. Funding and Collaborations - The company received an upfront payment of €25 million ($29.6 million) from Orion under the Orion Collaboration Agreement, with potential additional payments of up to €97 million based on clinical and commercial achievements[214]. - Under the Tenacia Collaboration Agreement, the company received a $10 million upfront payment and is eligible for up to $256 million in milestone payments related to ganaxolone[217]. - The company entered into a revenue interest financing agreement with Sagard, receiving $32.5 million and agreeing to make quarterly payments equal to 7.5% of U.S. net sales of ganaxolone[273][274]. - The BARDA Contract provides up to approximately $51 million for the development of IV-administered ganaxolone, with funding for a Phase 3 clinical trial and preclinical studies[209]. - The company is responsible for approximately $33 million in cost sharing under the BARDA Contract, while BARDA will cover approximately $52 million if all development options are completed[210]. Market Access and Patient Engagement - The U.S. marketing strategy focuses on establishing ZTALMY as central to the management of seizures associated with CDD and ensuring patient access from prescription to fulfillment[157]. - The company is actively engaging commercial and government payers to obtain insurance coverage for ZTALMY[156]. - The company has established a supply chain network and quality management system to ensure product availability for patients[156]. - A global managed access program has been initiated to support physician access to ZTALMY for appropriate patients[167]. - The company has strengthened its market access and field force teams to enhance payer and customer engagement[158]. Intellectual Property and Development - The company has received two patents related to the treatment of SE using IV ganaxolone, with the latest patent granted on June 20, 2023, expiring in 2040[181]. - The USPTO granted a patent on a method of treating TSC-related epilepsy by administering oral ganaxolone, expiring in 2040[191]. - The company is expanding its global intellectual property portfolio and hiring additional personnel to support drug development efforts[203]. - The company may need to acquire or obtain licenses for certain Ovid patents to market ganaxolone for RSE and LGS, which could impact commercialization[184][197]. Cash and Investments - As of September 30, 2023, the company had cash, cash equivalents, and short-term investments totaling $176.4 million, expected to fund operations for at least twelve months[290]. - Cash used in investing activities included $52.0 million in purchases of short-term investments, partially offset by $17.0 million in maturities[287]. - Cash provided by financing activities included $25.9 million in net proceeds from the sale of common stock and $0.8 million from the exercise of stock options[288]. - The company has drawn on three tranches of a $125.0 million credit agreement, with a fixed interest rate of 11.50% and quarterly principal payments starting June 30, 2024[266][268]. - The company is required to secure additional funding in the future to support commercialization and planned R&D activities for ganaxolone[257].
Marinus Pharmaceuticals(MRNS) - 2023 Q2 - Earnings Call Transcript
2023-08-10 16:20
Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS) Q2 2023 Earnings Conference Call August 10, 2023 8:30 AM ET Company Participants Sonia Weigle - SVP, IR, HR, and Corporate Affairs Scott Braunstein - Chairman and CEO Christy Shafer - CCO Joseph Hulihan - CMO Steven E. Pfanstiel - CFO and COO Conference Call Participants Brian Abrahams - RBC Capital Markets Joseph Thome - TD Cowen Andrew Tsai - Jefferies Charles Duncan - Cantor Fitzgerald Joon Lee - Truist Securities Marc Goodman - Leerink Partners Douglas Tsao - ...
Marinus Pharmaceuticals(MRNS) - 2023 Q2 - Earnings Call Presentation
2023-08-10 12:01
Corporate Presentation August 2023 Safe Harbor Statement To the extent that statements contained in this presentation 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 o ...
Marinus Pharmaceuticals(MRNS) - 2023 Q2 - Quarterly Report
2023-08-10 11:55
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMISSION FILE NUMBER 001-36576 MARINUS PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 20-0198082 (State or o ...
Marinus Pharmaceuticals(MRNS) - 2023 Q1 - Quarterly Report
2023-05-11 12:01
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMISSION FILE NUMBER 001-36576 MARINUS PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 20-0198082 (State or ...
Marinus Pharmaceuticals(MRNS) - 2022 Q4 - Annual Report
2023-03-09 21:03
Financial Viability and Profitability - The company may never achieve or sustain profitability, which could depress the market price of its common stock[19] - Additional capital will be required to fund operations, and failure to obtain necessary financing may hinder the commercialization of ZTALMY and the development of ganaxolone[19] - The future success of the company is dependent on the successful clinical development, regulatory approval, and commercialization of ganaxolone, which requires significant capital resources and time[19] Product Development and Commercialization - ZTALMY is the company's first commercial product, and there is a limited history of successfully commercializing drugs, making it difficult to evaluate future viability[19] - Regulatory approval for ZTALMY has been obtained in the U.S., but extensive FDA regulatory requirements remain, which may pose challenges[19] - The commercial success of ZTALMY depends on significant market access and acceptance among physicians, patients, and payers, as well as sufficient reimbursement for ganaxolone[19] - The company may face difficulties in differentiating ZTALMY from existing treatments, which could adversely affect commercialization efforts[19] - Failure to obtain regulatory approval in international jurisdictions would prevent ganaxolone from being marketed outside the U.S.[19] - Ganaxolone's clinical development may not yield favorable results, impacting regulatory approval across multiple indications[25] - The therapeutic efficacy and safety of ganaxolone in indications other than CDD have not been established, posing risks for future commercialization[25] - The company has limited experience in commercial-scale manufacturing of ganaxolone, relying on third parties[25] Market Competition and Challenges - The company operates in a competitive market, which may result in others commercializing products before or more successfully than it does[19] - Favorable reimbursement determinations have been received for ZTALMY, but adverse changes in reimbursement could harm the business[19] - Collaboration or out-license agreements for ganaxolone outside the U.S. may not be successful, limiting market potential[25] Manufacturing and Supply Chain Risks - The company relies on third-party manufacturers for ganaxolone production, which may lead to delays if issues arise[25] - The COVID-19 pandemic could adversely affect the company's ability to conduct and complete clinical trials[26] Intellectual Property and Legal Risks - Intellectual property rights protection may be inadequate, potentially harming the company's competitive position[25] - The company may face legal challenges regarding intellectual property rights from third parties, which could impact business operations[25] - Patent terms may not sufficiently protect the company's competitive position for an adequate duration[25] Government and Funding Risks - Government funding for research may impose additional costs and requirements, affecting commercialization efforts[25]
Marinus Pharmaceuticals(MRNS) - 2022 Q3 - Quarterly Report
2022-11-07 21:04
PART I – FINANCIAL INFORMATION [Item 1. Consolidated Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Consolidated%20Financial%20Statements%20(unaudited)) Presents Marinus Pharmaceuticals' unaudited consolidated financial statements, detailing the ZTALMY® launch, a significant PRV sale gain, and financing activities [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets) Cash and equivalents significantly increased to **$168.2 million** by Q3 2022, driven by financing and a PRV sale Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $168,249 | $122,927 | | Total current assets | $177,006 | $131,678 | | **Total assets** | **$184,841** | **$136,840** | | **Liabilities & Equity** | | | | Total current liabilities | $21,050 | $40,566 | | Notes payable, net | $70,780 | $40,809 | | **Total liabilities** | **$102,837** | **$83,354** | | **Total stockholders' equity** | **$82,004** | **$53,486** | [Consolidated Statements of Operations and Comprehensive Income (Loss)](index=4&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20(Loss)) Q3 2022 net income of **$73.3 million** resulted from a **$107.4 million** PRV sale gain and initial ZTALMY® revenue Q3 2022 vs Q3 2921 Statement of Operations (in thousands, except per share data) | Metric | Q3 2022 | Q3 2021 | | :--- | :--- | :--- | | Product revenue, net | $555 | $0 | | Total revenue | $2,340 | $10,114 | | Research and development | $19,002 | $18,353 | | Selling, general and administrative | $13,389 | $9,452 | | Loss from operations | ($30,099) | ($19,169) | | Gain from sale of priority review voucher, net | $107,375 | $0 | | **Net income (loss)** | **$73,290** | **($19,507)** | | **Net income (loss) per share—diluted** | **$1.89** | **($0.53)** | Nine Months 2022 vs 2021 Statement of Operations (in thousands, except per share data) | Metric | Nine Months 2022 | Nine Months 2021 | | :--- | :--- | :--- | | Product revenue, net | $555 | $0 | | Total revenue | $18,316 | $13,825 | | Research and development | $58,488 | $55,506 | | Selling, general and administrative | $42,187 | $26,656 | | Loss from operations | ($83,576) | ($69,815) | | Gain from sale of priority review voucher, net | $107,375 | $0 | | **Net income (loss)** | **$14,496** | **($70,471)** | | **Net income (loss) per share—diluted** | **$0.37** | **($1.92)** | [Consolidated Statements of Cash Flows](index=5&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was **$91.0 million**, offset by **$105.7 million** from PRV sale and financing Cash Flow Summary for Nine Months Ended Sep 30 (in thousands) | Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($90,972) | ($33,727) | | Net cash provided by (used in) investing activities | $105,693 | ($694) | | Net cash provided by financing activities | $30,601 | $41,013 | | **Net increase in cash and cash equivalents** | **$45,322** | **$6,592** | | **Cash and cash equivalents—end of period** | **$168,249** | **$145,101** | [Notes to Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) Notes detail ZTALMY® launch, **$110 million** PRV sale, Oaktree credit, Sagard financing, and liquidity assessment - ZTALMY® (ganaxolone) received FDA approval on March 18, 2022, and launched commercially in the U.S. in **Q3 2022**[20](index=20&type=chunk) - The company sold its Rare Pediatric Disease Priority Review Voucher (PRV) for **$110.0 million** in July 2022, with net proceeds received in August[23](index=23&type=chunk) - As of September 30, 2022, **$75.0 million** was drawn from the Oaktree credit agreement, with **$25.0 million** remaining available through December 2023, subject to milestones[26](index=26&type=chunk) - Post-quarter, on October 28, 2022, the company secured **$32.5 million** upfront from a revenue interest financing agreement with Sagard Healthcare Royalty Partners[115](index=115&type=chunk) - Management concluded that existing cash, including **$32.5 million** from Sagard, is sufficient to fund operations for at least the next twelve months, resolving going concern uncertainty[29](index=29&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=37&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses ZTALMY® launch, pipeline progress, financial results, and liquidity, projecting cash into **Q1 2024** [Our Products and Product Candidates](index=43&type=section&id=Our%20Products%20and%20Product%20Candidates) Details ZTALMY® commercial launch and ganaxolone pipeline development for SE and TSC, with key trial data expected in **2H 2023** and **Q1 2024** - ZTALMY® launched commercially in **Q3 2022**, generating **$0.6 million** in net product revenue and receiving over **50** prescription enrollment forms[138](index=138&type=chunk)[147](index=147&type=chunk) - The Phase 3 RAISE trial for RSE resumed in May 2022 after delays, with top-line data now anticipated in **2H 2023**[137](index=137&type=chunk)[161](index=161&type=chunk)[162](index=162&type=chunk) - The global Phase 3 TrustTSC trial is actively screening patients, with top-line data expected in **Q1 2024**[172](index=172&type=chunk) - A second-generation oral ganaxolone formulation is in development for twice-daily dosing, with a Phase 2 LGS trial planned for **2023**[173](index=173&type=chunk)[175](index=175&type=chunk) [Results of Operations](index=64&type=section&id=Results%20of%20Operations) Q3 and nine-month results were significantly impacted by a **$107.4 million** PRV sale gain, leading to **$73.3 million** net income for Q3 Revenue Breakdown (in thousands) | Revenue Source | Q3 2022 | Q3 2021 | Nine Months 2022 | Nine Months 2021 | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | $555 | $0 | $555 | $0 | | Federal contract revenue | $1,785 | $1,127 | $5,088 | $4,838 | | Collaboration revenue | $0 | $8,987 | $12,673 | $8,987 | | **Total Revenue** | **$2,340** | **$10,114** | **$18,316** | **$13,825** | - A one-time net gain of **$107.4 million** from the PRV sale was recognized in **Q3 2022**[219](index=219&type=chunk) Operating Expenses (in thousands) | Expense Category | Q3 2022 | Q3 2021 | Nine Months 2022 | Nine Months 2021 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $19,002 | $18,353 | $58,488 | $55,506 | | Selling, general and administrative | $13,389 | $9,452 | $42,187 | $26,656 | - Increased SG&A expenses were primarily due to higher personnel, training, and commercialization preparation costs for the ZTALMY® launch[217](index=217&type=chunk) [Liquidity and Capital Resources](index=70&type=section&id=Liquidity%20and%20Capital%20Resources) Cash and equivalents totaled **$168.2 million** as of Q3 2022, bolstered by PRV sale and financing, projected to fund operations into **Q1 2024** - Cash and cash equivalents totaled **$168.2 million** at September 30, 2022[222](index=222&type=chunk) - Existing cash, including **$32.5 million** from Sagard, is expected to fund operations into **Q1 2024**[180](index=180&type=chunk)[242](index=242&type=chunk) - **$75.0 million** has been drawn from the Oaktree credit facility, with an additional **$25.0 million** available through December 2023, subject to milestones[225](index=225&type=chunk)[226](index=226&type=chunk)[227](index=227&type=chunk) - Cash used in operating activities for the nine months ended September 30, 2022, was **$91.0 million**, up from **$33.7 million** in 2021[237](index=237&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=78&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Marinus is exempt from providing quantitative and qualitative disclosures about market risk - As a smaller reporting company, Marinus is not required to provide quantitative and qualitative disclosures about market risk[249](index=249&type=chunk) [Item 4. Controls and Procedures](index=79&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of September 30, 2022, with no material changes in internal control - The CEO and CFO concluded that disclosure controls and procedures were effective as of September 30, 2022[250](index=250&type=chunk) - No material changes to internal control over financial reporting occurred during **Q3 2022**[251](index=251&type=chunk) PART II – OTHER INFORMATION [Item 1. Legal Proceedings](index=80&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings or aware of any pending actions - The company is not currently involved in any material legal proceedings[254](index=254&type=chunk) [Item 1A. Risk Factors](index=80&type=section&id=Item%201A.%20Risk%20Factors) Highlights material changes to financial and IP risks, including potential debt defaults, Oaktree funding, and patent infringement litigation - Debt agreements with Oaktree and Sagard contain restrictive covenants and minimum liquidity requirements of **$15.0 million**, risking default if breached[256](index=256&type=chunk)[269](index=269&type=chunk)[273](index=273&type=chunk) - Drawing the final **$25.0 million** Oaktree tranche is contingent on achieving financing and clinical trial milestones, which may not be met[272](index=272&type=chunk) - Risk of legal proceedings from third parties, such as Ovid Therapeutics, regarding patents that may encompass the SE product candidate[280](index=280&type=chunk) - Drug product quality issues, like the IV ganaxolone manufacturing problem, pose risks to clinical development timelines and approvals[281](index=281&type=chunk)[283](index=283&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=90&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During the nine months ended September 30, 2022, **10,802** shares were withheld for tax obligations from restricted stock vesting - A total of **10,802** shares were withheld to satisfy taxes related to vested restricted stock during the nine months ended September 30, 2022[284](index=284&type=chunk) [Item 3. Defaults Upon Senior Securities](index=90&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported [Item 4. Mine Safety Disclosures](index=90&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations [Item 5. Other Information](index=90&type=section&id=Item%205.%20Other%20Information) No other material information was reported [Item 6. Exhibits](index=92&type=section&id=Item%206.%20Exhibits) Lists exhibits filed with Form 10-Q, including new financing agreements and officer certifications - Key exhibits filed include the Revenue Interest Financing Agreement with Sagard and the First Amendment to the Credit Agreement with Oaktree[289](index=289&type=chunk)
Marinus Pharmaceuticals(MRNS) - 2022 Q2 - Quarterly Report
2022-08-11 20:02
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMISSION FILE NUMBER 001-36576 MARINUS PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 20-0198082 (State or o ...
Marinus Pharmaceuticals(MRNS) - 2022 Q1 - Quarterly Report
2022-05-12 20:31
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMISSION FILE NUMBER 001-36576 MARINUS PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 20-0198082 (State or ...