Marinus Pharmaceuticals, Inc.

Marinus reported ZTALMY product revenue of $8 million in Q2 2024 and $15.5 million for the first six months of 2024, versus $4.2 million and $7.6 million in the prior-year periods. That implies year-over-year growth of 87% for the quarter, and management said this was consistent with full-year 2024 revenue guidance of $33 million to $35 million. BARDA revenue was $0.1 million in Q2 and $0.2 million year to date, versus $1.8 million and $8.9 million a year ago. R&D expense was $20.9 million in Q2 and $45 million year to date; SG&A was $16.7 million in Q2 and $35.3 million year to date; restructuring costs were $2 million in Q2. Net loss before income taxes was $35.8 million in Q2 and $74.5 million year to date, and cash and cash equivalents were $64.7 million at June 30. The company said its cash runway now extends into Q2 2025, SG&A plus R&D is expected to fall to $55 million to $60 million in the second half from $80.3 million in the first half, and full-year SG&A plus R&D guidance remains about $135 million to $140 million including about $20 million of noncash stock-based compensation.

Scott Braunstein emphasized that 2024 has brought significant commercial, clinical, and operational progress, with ZTALMY now approved in the U.S., EU, UK, and China for CDD and additional ex-U.S. launches expected soon. He framed the TSC readout as the next major catalyst and said the team is preparing to leverage the existing ZTALMY infrastructure for a potential TSC launch in the second half of 2025. His tone was confident and strategic, with repeated emphasis on global expansion, manufacturing scale-up, and the goal of company profitability within 12 to 18 months after a TSC launch.

Steve Pfanstiel said the company took actions after the Phase 3 RAISE result to extend cash runway into Q2 2025, including cost reductions and debt restructuring with Oaktree and Sagard. He noted the $15 million minimum liquidity requirement was removed, 2024 amortization to Oaktree was cut by 50%, and Marinus made a one-time $15 million principal payment, leaving $60 million of Oaktree principal outstanding. He also reiterated unchanged full-year guidance for ZTALMY revenue of $33 million to $35 million and combined SG&A/R&D of approximately $135 million to $140 million, with about $20 million of stock-based compensation included, while stating second-half combined SG&A/R&D should fall to $55 million to $60 million from $80.3 million in the first half.

Analysts focused on ZTALMY patient adds, persistence, and whether medical meetings are driving prescriptions; management said new patient additions have been steadily growing each quarter and that persistence remains north of 70%, with prescriptions often strengthening after medical meetings. Questions also centered on TrustTSC design and confidence in the Phase 3 readout; management highlighted that the Phase 3 trial includes the right seizure types and many patients on mTOR inhibitors or cannabidiol, and that discontinuations are below 7% versus 26% in Phase 2. On the IV ganaxolone program, analysts pressed on the FDA meeting and whether a new study could be done in 1 to 2 years; management said it plans to request an FDA meeting this month and believes a future trial could be feasible, but only with a more objective endpoint than avoidance of IV anesthesia. Another question addressed off-label use and milestones; the company said about 15% of patients on therapy do not have a CDD diagnosis, most payers are covering them, and the nearest milestone is an EUR10 million payment from Orion upon commercialization in certain markets.