Zevra Therapeutics(US:ZVRA)2025-11-05 22:21Financial Performance - 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, marking a growth of 605%[19] - For the nine months ended September 30, 2025, total revenues reached $72.3 million, compared to $11.6 million for the same period in 2024, indicating a growth of about 522%[86] - Net income for the nine months ended September 30, 2025, was $71,064,000, a significant improvement compared to a net loss of $69,772,000 for the same period in 2024[27] - The company reported a gain on the sale of PRV amounting to $148,325,000 for the nine months ended September 30, 2025[19] - Other income for the nine months ended September 30, 2025, was $146.3 million, compared to $1.8 million in the same period of 2024, mainly due to a gain on the sale of the PRV[205] Assets and Liabilities - Total current assets increased to $225,115,000 as of September 30, 2025, compared to $86,027,000 as of December 31, 2024, representing a growth of 162%[18] - Total liabilities decreased slightly to $136,951,000 as of September 30, 2025, from $138,461,000 as of December 31, 2024[18] - The company’s total assets increased to $270,116,000 as of September 30, 2025, from $178,127,000 as of December 31, 2024, reflecting a growth of 51%[18] - As of September 30, 2025, the Company held investment securities with an aggregate fair value of $175.9 million, up from $41.7 million as of December 31, 2024, reflecting a significant increase in investment holdings[38] - Long-term debt as of September 30, 2025, was $61.3 million, an increase from $59.5 million as of December 31, 2024[85] Equity and Stockholder Information - Stockholders' equity increased significantly to $133,165,000 as of September 30, 2025, compared to $39,666,000 as of December 31, 2024, reflecting an increase of 235%[18] - The balance of stockholders' equity as of September 30, 2024, was $69,770,000, reflecting a decrease from previous periods due to net losses[24] - The fair value of the warrant liability was approximately $13.8 million as of September 30, 2025, down from $17.8 million as of December 31, 2024[106] - The balance of common stock warrant liabilities decreased to $13,767,000 as of September 30, 2025, from $17,804,000 as of December 31, 2024, reflecting a decline of 22.8%[118] Expenses - Operating expenses for the nine months ended September 30, 2025, totaled $67,385,000, a decrease from $72,486,000 in the same period of 2024, showing a reduction of approximately 7%[19] - Research and development expenses directly identified to programs for the three months ended September 30, 2025, were $1.8 million, down from $4.9 million in 2024, a decrease of approximately 64%[77] - Selling, general and administrative expenses directly identified to programs for the three months ended September 30, 2025, were $5.1 million, an increase from $4.9 million in 2024, reflecting a growth of about 4%[77] - Research and development expenses for the nine months ended September 30, 2025, were $3,322,000, down from $4,696,000 in 2024, reflecting a decrease of 29.3%[112] - Selling, general and administrative expenses increased by approximately $18.5 million, from $38.7 million in 2024 to $57.3 million in 2025, driven by higher personnel-related costs and professional fees[204] Cash Flow - Cash flows from operating activities resulted in a net cash used of $7,114,000 for the nine months ended September 30, 2025, compared to $53,415,000 in 2024[27] - The company reported a net cash provided by financing activities of $9,518,000 for the nine months ended September 30, 2025, compared to $81,312,000 in 2024[27] - As of September 30, 2025, the company had cash, cash equivalents, and investments totaling $230.4 million[206] Product Development and Regulatory Approvals - On September 20, 2024, the FDA approved MIPLYFFA (arimoclomol) for Niemann-Pick disease type C, marking it as the first FDA-approved treatment for this condition[29] - MIPLYFFA generated sales of $22.4 million and $61.0 million for the three and nine months ended September 30, 2025, respectively[88] - The company is focusing on obtaining regulatory approval for MIPLYFFA in Europe, having submitted a Marketing Authorization Application (MAA) in July 2025[155] - Celiprolol is being advanced as an investigational product for Vascular Ehlers-Danlos Syndrome (VEDS) and has received orphan drug designation from the FDA[165] - The DiSCOVER trial for celiprolol aims to enroll 150 VEDS patients, with 44 participants enrolled as of September 30, 2025[168] Impairments and Write-downs - The company recognized an impairment of intangible assets amounting to $58,710,000 in 2025, while there was no such charge in 2024[27] - The company recorded an intangible asset impairment charge of $58.7 million for the nine months ended September 30, 2025, related to the OLPRUVA asset group, which was determined to be not fully recoverable[128] - The Company recognized charges of approximately $11.7 million for unsaleable inventory for the nine months ended September 30, 2025, compared to $5.2 million for the same period in 2024[59] Market and Sales Information - The estimated incidence of NPC is one in 100,000 to 130,000 live births, with approximately 2,000 individuals affected in the U.S. and Europe combined, including about 900 in the U.S.[150] - OLPRUVA, approved in the U.S. for chronic management of Urea Cycle Disorders (UCDs), began generating revenue in Q4 2023[160] - The company has generated revenue from product sales of MIPLYFFA and OLPRUVA, as well as reimbursements under the French expanded access program, with royalties and milestone payments contributing to revenue streams[60]