Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Marinus Pharmaceuticals, Inc. due to a class action complaint alleging breaches of fiduciary duties by the board of directors during the specified class period [1][2]. Group 1: Legal Investigation - The investigation is focused on whether Marinus' board of directors made materially false and misleading statements regarding the company's business and operations [2]. - The class action complaint was filed on June 5, 2024, covering a class period from March 17, 2021, to May 7, 2024 [1]. - Allegations include the understatement of risks related to the RAISE trial and the failure to disclose potential consequences of not meeting early-stopping criteria [2]. Group 2: Contact Information - Long-term stockholders of Marinus are encouraged to contact Bragar Eagel & Squire for more information regarding their legal rights and the ongoing investigation [3][6]. - Contact can be made via email or telephone, with no cost or obligation to the stockholders [3].

Nasdaq: MRNS @MarinusPharma Photo Credit: Kelly Crews Photography Ryan (center) Living with CDKL5 deficiency disorder 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", ...

Core Viewpoint - Marinus Pharmaceuticals (MRNS) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system reflects changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - Rising earnings estimates for Marinus Pharmaceuticals suggest an improvement in the company's underlying business, likely leading to increased stock prices [5][10]. Recent Earnings Estimate Revisions - Marinus Pharmaceuticals is projected to earn -$2.03 per share for the fiscal year ending December 2024, representing a year-over-year change of 22.8% [8]. - Over the past three months, the Zacks Consensus Estimate for Marinus has increased by 44.2%, indicating a positive trend in earnings expectations [8]. Zacks Rank System Overview - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with only the top 20% receiving a 'Strong Buy' or 'Buy' rating [9][10]. - The upgrade of Marinus Pharmaceuticals to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

Core Viewpoint - Marinus Pharmaceuticals reported a quarterly loss of $0.42 per share, slightly better than the consensus estimate of a loss of $0.44, and improved from a loss of $0.61 per share a year ago, indicating a 30.8% year-over-year improvement in loss per share [1][2] Financial Performance - The company posted revenues of $8.54 million for the quarter ended September 2024, missing the Zacks Consensus Estimate by 4.59%, but showing a year-over-year increase from $7.34 million [2] - Over the last four quarters, Marinus Pharmaceuticals has surpassed consensus EPS estimates only once, indicating challenges in meeting market expectations [2] Stock Performance - Marinus Pharmaceuticals shares have declined approximately 96.9% since the beginning of the year, contrasting sharply with the S&P 500's gain of 25.8% [3] - The current Zacks Rank for the stock is 3 (Hold), suggesting that shares are expected to perform in line with the market in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.22 on revenues of $12.51 million, and for the current fiscal year, it is -$2.03 on revenues of $37.18 million [7] - The trend of estimate revisions for Marinus Pharmaceuticals is mixed, which could change following the recent earnings report [6] Industry Context - The Medical - Drugs industry, to which Marinus Pharmaceuticals belongs, is currently ranked in the top 27% of over 250 Zacks industries, indicating a favorable industry outlook [8]

Revenue Performance - ZTALMY net product revenue reached $8.5 million for Q3 2024, up from $5.4 million in Q3 2023, representing a 57.4% increase[139] - The company recorded a total of $23.9 million in net product revenue for the nine months ended September 30, 2024, compared to $13.0 million for the same period in 2023, indicating an 83.0% year-over-year growth[139] - For the three months ended September 30, 2024, total revenue was $16.3 million, a decrease from $23.7 million in the same period of 2023, representing a decline of approximately 31.5%[214] - For the nine months ended September 30, 2024, total revenue was $61.3 million, compared to $73.0 million for the same period in 2023, reflecting a decrease of about 16.0%[214] Clinical Development and Trials - The FDA approved ZTALMY for the treatment of seizures associated with CDKL5 Deficiency Disorder (CDD) in March 2022, and the European Commission granted marketing authorization for the same indication in July 2023[132] - The RAISE trial for intravenous ganaxolone showed an 80% cessation of status epilepticus within 30 minutes compared to 13% for placebo (p < 0.0001), although it failed to meet the second co-primary endpoint[137] - ZTALMY achieved a median 30.7% reduction in 28-day major motor seizure frequency in a Phase 3 trial, compared to a 6.9% reduction for placebo, meeting the primary endpoint (p=0.0036) [144] - In the open-label extension phase of the Marigold Trial, patients treated with ZTALMY experienced a median 48.2% reduction in major motor seizure frequency over two years [144] - The TrustTSC trial did not meet its primary endpoint, showing a median reduction of 19.7% in TSC-associated seizure frequency for ganaxolone compared to 10.2% for placebo (p=0.09) [164] - The company discontinued further ganaxolone clinical development except for FDA and EMA post-approval commitments due to the TrustTSC outcome[172] Financial Performance - Net losses were $24.2 million and $98.7 million for the three and nine months ended September 30, 2024, with an accumulated deficit of $670.6 million[179] - Cash and cash equivalents were $42.2 million as of September 30, 2024, expected to fund operations into Q2 2025[180] - Cash used in operating activities was $87.8 million for the nine months ended September 30, 2024, a slight improvement from $91.0 million in the same period of 2023[229] - Interest income for the three months ended September 30, 2024 was $0.6 million, down from $1.9 million in the same period of 2023, a decrease of about 68.4%[226] - Interest expense for the nine months ended September 30, 2024 was $12.8 million, slightly up from $12.6 million in the same period of 2023[227] Workforce and Cost Management - The company announced a 45% reduction in workforce in Q4 2024 following the discontinuation of further ganaxolone clinical development for Tuberous Sclerosis Complex (TSC) after the Phase 3 trial did not meet its primary endpoint[134] - The company anticipates that cost reduction activities will fund operating expenditures into Q2 2025[126] - The company implemented a 45% workforce reduction in Q4 2024 to cut costs[172] - Restructuring costs amounted to approximately $2.0 million for the nine months ended September 30, 2024, with no comparable costs in 2023[224] Strategic Initiatives - The company is exploring strategic alternatives to maximize shareholder value and has engaged Barclays as an advisor for this process[135] - The company has a collaboration agreement with Orion for the commercialization of ganaxolone in Europe, with potential launches pending strategic review outcomes[132] - The company has entered into agreements for commercialization of ganaxolone in various territories, including with NovaMedica and Biologix, expanding its market reach[199] Intellectual Property - The U.S. Patent and Trademark Office granted multiple patents related to ganaxolone, with expiration dates ranging from 2040 to 2042 [167] - The USPTO granted two patents related to the treatment of SE using IV ganaxolone, expiring in 2040 and 2023, strengthening the company's intellectual property portfolio[174] Contracts and Agreements - The BARDA Contract provides up to approximately $51 million for the development of IV-administered ganaxolone, with $21 million recorded as of December 31, 2023[185][186] - The company has a cost-sharing obligation of approximately $33 million under the BARDA contract, while BARDA is responsible for approximately $52 million if all development options are completed[243] - The company agreed to make quarterly payments to Sagard equal to 7.5% of U.S. net sales of ZTALMY and other ganaxolone products until June 30, 2026, and 15.0% of the first $100 million in annual product revenue thereafter[239] - The total payments to Sagard are capped at 190% of the investment amount, which is approximately $61.8 million[240]

Financial Performance - ZTALMY® (ganaxolone) reported Q3 2024 net product revenue of $8.5 million, reflecting a 56% increase compared to Q3 2023[1]. - Full year 2024 net product revenue guidance for ZTALMY has been narrowed to $33 to $34 million[1]. - The company reported net losses of $24.2 million for Q3 2024, compared to $32.9 million for Q3 2023[10]. Cash Position - Marinus Pharmaceuticals has cash and cash equivalents of $42.2 million as of September 30, 2024, expected to fund operations into Q2 2025[6]. - The company's cash and cash equivalents may not be sufficient to support its operating plan for the anticipated duration[13]. Expenses - R&D expenses decreased to $16.3 million for Q3 2024 from $23.7 million in Q3 2023, primarily due to reduced costs associated with the RAISE trial[8]. - SG&A expenses for Q3 2024 were $12.6 million, down from $14.9 million in Q3 2023, driven by decreased personnel and consulting expenses[8]. Strategic Initiatives - Marinus has engaged Barclays to assist in exploring strategic alternatives to maximize stockholder value[6]. - Marinus has suspended further ganaxolone clinical development as part of its cost reduction plans, which include a workforce reduction of approximately 45%[6]. Regulatory and Clinical Development - The FDA has granted a Type C meeting to discuss a potential path forward for intravenous ganaxolone in refractory status epilepticus, scheduled for Q4 2024[4]. - The topline results from the Phase 3 TrustTSC trial did not achieve statistical significance in the primary endpoint[4]. - Compliance with FDA requirements for additional post-marketing studies is critical for the company's products[13]. Market Risks - Marinus Pharmaceuticals faces substantial risks and uncertainties that could impact clinical development programs and future performance[13]. - Market acceptance, payor coverage, and future prescriptions for ZTALMY remain uncertain, potentially affecting revenue generation[13]. - The pricing and reimbursement process for ZTALMY may delay its commercialization in European countries[13]. - The company must navigate competitive conditions and unexpected adverse events related to ZTALMY treatment[13]. - Future revenue projections and capital requirements are subject to uncertainties regarding expenses and financing availability[13]. - Delays or failures in the manufacture and supply of products could impact the company's operations[13]. - The company must protect its intellectual property to maintain its market position[13].

Core Viewpoint - Marinus Pharmaceuticals (MRNS) is a micro-cap pharmaceutical company with significant upside potential as indicated by analysts' price targets, ranging from $6 to $13, suggesting potential increases of 241% to over 700% from current levels [1][2]. Company Overview - Marinus Pharmaceuticals is in the commercial stage, having FDA-approved medications, which allows it to generate revenue, unlike many small pharmaceutical companies still in the clinical stage [3][4]. - The company's primary drug, ganaxolone, marketed as ZTALMY, was approved in 2022 for treating CDKL5 deficiency disorder, a rare genetic epilepsy affecting approximately 100 newborns annually [5]. Financial Performance - Over the last four quarters, Marinus's revenue has been modest, ranging from $7 million to $8 million, with a year-over-year revenue increase of 87% last quarter, reaching $7.9 million [4][6]. - A significant portion of the revenue comes from Medicaid, which typically offers lower reimbursement rates compared to private insurance, impacting overall revenue per prescription [6]. Challenges and Risks - Marinus faced a setback with its Phase 3 trial for an intravenous version of ganaxolone aimed at treating refractory status epilepticus (RSE), resulting in an 82% drop in share price following disappointing trial results [7][8]. - The company is exploring a partnership for further research on the intravenous version of ganaxolone, which may reduce potential revenue from this drug [8]. Future Prospects - Marinus is also working on treating Tuberous Sclerosis Complex (TSC) with oral ganaxolone, which has a larger potential market, affecting between 25,000 and 50,000 people in the U.S. [9][10]. - The Phase 3 trial results for TSC are anticipated before the presidential election, with positive results potentially leading to drug approval by late 2025 to early 2026, representing a critical inflection point for the company [11].

Corporate Presentation August 2024 Nasdaq: MRNS @MarinusPharma Photo Credit: Kelly Crews Photography Ryan (center) Living with CDKL5 deficiency disorder 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 "ma ...

Financial Data and Key Metrics Changes - In Q2 2024, Marinus Pharmaceuticals reported net product revenue of $8 million, representing an increase of over 85% compared to the same period in 2023 [14][37] - The company projects full-year 2024 revenue guidance of between $33 million and $35 million, unchanged from previous estimates [37] - Combined selling, general and administrative (SG&A) and R&D expenses are expected to decrease by approximately 30% in the second half of 2024, from $80.3 million in the first half to between $55 million and $60 million [35][36] Business Line Data and Key Metrics Changes - The ZTALMY brand has seen steady growth with approximately 200 patients active on therapy, and a low discontinuation rate of less than 30% [14][15] - The company has made significant investments to expand manufacturing capacity to meet expected increased demand for ZTALMY [7][36] Market Data and Key Metrics Changes - ZTALMY is now approved in the US, EU, UK, and China for patients with CDKL5 deficiency disorder (CDD), with plans for launches in additional markets [8][9] - Over 1,000 CDD patients have been identified in China, indicating a meaningful global opportunity for ZTALMY [9] Company Strategy and Development Direction - Marinus is preparing for a Phase 3 readout in tuberous sclerosis complex (TSC) and aims to expand access to ZTALMY globally [4][10] - The company plans to leverage its existing infrastructure for ZTALMY to support the TSC launch, targeting submission of a supplemental NDA by April 2025 [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving corporate profitability within 12 to 18 months following the TSC launch, citing the significant unmet need in the TSC patient population [11][19] - The company is optimistic about the upcoming Phase 3 data readout and believes it will create unique growth potential [12][30] Other Important Information - Marinus successfully challenged a patent related to IV ganaxolone, which may enhance its competitive position [12] - The company has engaged in collaborations and distribution agreements in various regions to facilitate the availability of ganaxolone [6][8] Q&A Session Summary Question: Can you provide more color on new patient additions in the quarter and persistence on therapy? - Management noted steady growth in new patient additions and highlighted that over 70% of patients remain on therapy, indicating strong persistence [44][45] Question: Can you discuss subgroup analyses from the Phase 2 study? - Management confirmed that over 90% of patients from the Phase 3 study are transitioning into the open-label extension, reflecting good tolerability [50][51] Question: What is the timing for the Type C meeting with the FDA? - Management indicated that the regulatory team is preparing for the meeting and is optimistic about the efficacy data from the IV ganaxolone trial [64][68]

Core Viewpoint - Marinus Pharmaceuticals reported a quarterly loss of $0.60 per share, slightly worse than the Zacks Consensus Estimate of a loss of $0.59, indicating a negative earnings surprise of -1.69% [1][2] Financial Performance - The company posted revenues of $8.06 million for the quarter ended June 2024, missing the Zacks Consensus Estimate by 11.02%, but showing an increase from $6.08 million in the same quarter last year [2] - Over the last four quarters, Marinus Pharmaceuticals has surpassed consensus EPS estimates only once [2] Stock Performance - Marinus Pharmaceuticals shares have declined approximately 88.7% since the beginning of the year, contrasting with the S&P 500's gain of 12.1% [3] Future Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.42 on revenues of $9.92 million, and for the current fiscal year, it is -$1.87 on revenues of $39.42 million [7] - The estimate revisions trend for Marinus Pharmaceuticals is currently unfavorable, resulting in a Zacks Rank 4 (Sell) for the stock, indicating expected underperformance in the near future [6] Industry Context - The Medical - Drugs industry, to which Marinus Pharmaceuticals belongs, is currently in the top 35% of over 250 Zacks industries, suggesting that stocks in the top half of Zacks-ranked industries tend to outperform those in the bottom half by more than 2 to 1 [8]