Marinus Pharmaceuticals(MRNS) - 2024 Q2 - Earnings Call Transcript

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]