Zevra Reports Fourth Quarter and Full Year 2025 Financial Results

Core Insights - Zevra Therapeutics reported a Q4 net revenue of $34.1 million, marking a 31% growth quarter-over-quarter, and a full-year net revenue of $106.5 million for FY 2025, primarily driven by MIPLYFFA's net revenue of $87.4 million [1][6] - The company achieved a net income of $83.2 million for FY 2025, translating to earnings per share (EPS) of $1.40 basic and $1.35 diluted, a significant turnaround from a net loss of $(105.5) million in FY 2024 [12][33] - MIPLYFFA, the company's therapy for Niemann-Pick disease type C, has shown strong performance and is positioned for further growth, with market access reaching 68% of covered lives in the U.S. [2][7] Financial Highlights - Q4 2025 net revenue included $26.4 million from MIPLYFFA, $0.4 million from OLPRUVA, $5.6 million in net reimbursements from the Expanded Access Program (EAP), and $1.8 million in royalties [12][10] - Operating expenses for Q4 2025 were $23.0 million, with R&D expenses at $2.6 million, a decrease from $8.4 million in Q4 2024, while SG&A expenses rose to $20.4 million [12][10] - The company had cash, cash equivalents, and securities totaling $238.9 million as of December 31, 2025, indicating strong financial flexibility [12][10] Product and Pipeline Developments - MIPLYFFA has been designated as an Orphan Medicinal Product by the European Medicines Agency (EMA), with a Marketing Authorisation Application currently under review [7][13] - The company enrolled eight patients in the Phase 3 DiSCOVER trial for Vascular Ehlers-Danlos Syndrome during Q4 2025, totaling 52 enrolled patients by year-end [4] - The EAP for MIPLYFFA has enrolled 113 patients globally, with a distribution agreement executed to broaden access beyond Europe [7][4] Strategic Focus - The company has relocated its global corporate headquarters to Boston to enhance access to specialized talent and is focused on executing multiple near-term growth opportunities in 2026 [2] - Zevra aims to create meaningful value for the rare disease community and its shareholders through disciplined execution of its strategic priorities [2][29]