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] - Revenue for the three months ended September 30, 2025, was $26,063,000, a significant increase from $3,695,000 in the same period of 2024, representing a growth of 605%[31] - For the nine months ended September 30, 2025, revenue reached $72,345,000, compared to $11,569,000 in 2024, marking a growth of 524%[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 in the same period of 2024[31] Operating Expenses - Operating expenses for Q3 2025 were $20.4 million, a decrease from $27.2 million in Q3 2024, primarily due to reduced R&D costs[7] - Operating expenses for the three months ended September 30, 2025, were $20,367,000, a decrease from $27,153,000 in the same period of 2024, representing a reduction of 25%[31] Research and Development - R&D expenses decreased to $3.4 million in Q3 2025 from $10.9 million in Q3 2024, reflecting completion of the KP1077 Phase 2 trial[7] - The company enrolled five patients in the Phase 3 DiSCOVER trial for Celiprolol, bringing total enrollment to 44 patients[5] Cash Position - Cash position as of September 30, 2025, was $230.4 million, sufficient to execute strategic priorities without reliance on capital markets[7] - Cash and cash equivalents increased to $54,439,000 as of September 30, 2025, compared to $33,785,000 at the end of 2024, reflecting a growth of 61%[33] Assets and Liabilities - Total current assets as of September 30, 2025, amounted to $225,115,000, up from $86,027,000 at the end of 2024, indicating a growth of 162%[33] - The company’s total liabilities decreased slightly to $136,951,000 as of September 30, 2025, from $138,461,000 at the end of 2024[33] - The accumulated deficit improved to $(434,225,000) as of September 30, 2025, compared to $(505,289,000) at the end of 2024[33] Product Development and Market Access - MIPLYFFA has achieved market access for 66% of covered lives, while OLPRUVA reached 81%[5] - MIPLYFFA has been designated as an Orphan Medicinal Product by the European Medicines Agency for the treatment of Niemann-Pick disease type C[12] - The company plans to maintain product availability and support services for OLPRUVA while evaluating options for the product[5] - The company has initiated discussions regarding the potential global expansion of MIPLYFFA® and ongoing submissions to the EMA for arimoclomol[29] Company Vision - Zevra Therapeutics is focused on becoming a leading, commercially focused rare disease company, with ongoing research and development activities planned for the future[29]
Kempharm(KMPH) - 2025 Q3 - Quarterly Results