Zevra Therapeutics(ZVRA) - 2025 Q3 - Quarterly Results

Financial Performance - Q3 2025 net revenue was $26.1 million, with MIPLYFFA® contributing $22.4 million, compared to $3.7 million in Q3 2024[7] - Zevra Therapeutics reported net revenue of $26,063,000 for the three months ended September 30, 2025, compared to $3,695,000 for the same period in 2024, representing a significant increase of 605%[31] - The company reported a net income of $71,064,000 for the nine months ended September 30, 2025, compared to a net loss of $69,772,000 for the same period in 2024[31] Operating Expenses - Operating expenses decreased to $20.4 million in Q3 2025 from $27.2 million in Q3 2024, with R&D expenses down to $3.4 million[7] - The company’s total operating expenses for the nine months ended September 30, 2025, were $67,385,000, a decrease of 7% from $72,486,000 in the same period of 2024[31] - Zevra's research and development expenses for the three months ended September 30, 2025, were $3,432,000, a decrease of 69.7% from $10,945,000 in the same period of 2024[31] - The company’s selling, general and administrative expenses for the nine months ended September 30, 2025, were $57,262,000, an increase of 47.5% from $38,743,000 in the same period of 2024[31] Loss and Cash Position - Net loss for Q3 2025 was $(0.5) million, or $(0.01) per share, significantly improved from a net loss of $(33.2) million, or $(0.69) per share, in Q3 2024[7] - Cash position stood at $230.4 million as of September 30, 2025, providing sufficient resources for strategic priorities[7] - Zevra's cash and cash equivalents increased to $54,439,000 as of September 30, 2025, up from $33,785,000 at the end of 2024, indicating improved liquidity[33] - The company’s accumulated deficit improved to $(434,225,000) as of September 30, 2025, compared to $(505,289,000) at the end of 2024[33] Market Access and Product Development - MIPLYFFA achieved market access for 66% of covered lives, while OLPRUVA reached 81%[5] - A Marketing Authorization Application for arimoclomol is under review by the European Medicines Agency[5] - MIPLYFFA has been designated as an Orphan Medicinal Product by the EMA, highlighting its significance in treating Niemann-Pick disease type C[12] - The company plans to scale back sales and marketing efforts for OLPRUVA while maintaining product availability[5] Clinical Trials - Five patients were enrolled in the Phase 3 DiSCOVER trial for Celiprolol, totaling 44 enrolled patients[5] - MIPLYFFA's clinical data showed a decline in annual disease progression for patients switching from placebo[7] Assets and Liabilities - The total assets of Zevra Therapeutics rose to $270,116,000 as of September 30, 2025, compared to $178,127,000 at the end of 2024, reflecting a growth of 51.7%[33] - Zevra's total liabilities decreased slightly to $136,951,000 as of September 30, 2025, from $138,461,000 at the end of 2024[33] Shareholder Information - The weighted-average shares of common stock outstanding increased to 55,951,572 for the three months ended September 30, 2025, compared to 47,808,817 for the same period in 2024[31]