Zevra Therapeutics Reports $105.5 Million Net Loss for 2024, Revenue Declines to $23.6 Million

Zevra Therapeutics, Inc. reported a net loss of $105.5 million for the year ended December 31, 2024, compared to a net loss of $46.0 million in 2023. The increase in net loss was primarily driven by a $37.4 million rise in loss from operations, a $5.9 million increase in interest expense, and a $15.4 million income tax expense, partially offset by a $2.2 million increase in the fair value adjustment related to derivative and warrant liability and CVR liability. Revenue for 2024 was $23.6 million, a decrease of approximately $3.8 million compared to 2023, primarily due to lower AZSTARYS License Agreement revenue and consulting revenue, partially offset by increased MIPLYFFA product sales and EAP revenue. Cost of product revenue increased to $7.4 million in 2024 from $2.2 million in 2023, mainly due to inventory obsolescence related to OLPRUVA and increased costs associated with MIPLYFFA and OLPRUVA sales and royalties.

Significant changes during the fiscal year included the completion of the acquisition of Acer Therapeutics, Inc. on November 17, 2023, adding OLPRUVA to Zevra's commercial product portfolio. The FDA approved MIPLYFFA (arimoclomol) for the treatment of Niemann-Pick disease type C on September 20, 2024, generating $10.1 million in product sales during the year. Zevra also received a transferable rare pediatric disease priority review voucher, which was subsequently sold for gross proceeds of $150 million (subject to customary closing conditions). In the third quarter of 2024, the company discontinued in-house drug discovery activities and closed its laboratory facilities in Iowa and Virginia, shifting its focus to late-stage clinical development and commercial opportunities.

Operational developments included the commercial launch of MIPLYFFA in November 2024, with 109 enrollments by year-end, including the conversion of all active participants in the U.S. EAP. The company also initiated the commercial launch of OLPRUVA in the first half of 2024, focusing initially on metabolic treatment centers of excellence. By the end of the third quarter of 2024, reimbursement coverage for OLPRUVA had increased to approximately 76% of U.S. covered lives. The company's headcount was 59 full-time employees as of December 31, 2024. Clinical trials for celiprolol for VEDS and KP1077 for IH and narcolepsy are ongoing, with strategic alternatives being evaluated for KP1077.

The company's financial statements reflect the inclusion of Acer's results from November 18, 2023, onward. Acer reported total operating revenue of $42,000 and a net loss of $6.8 million for the period from November 18, 2023, to December 31, 2023. Zevra's five-year strategic plan focuses on transforming into a leading rare-disease company, including further pipeline expansion through collaborations, partnerships, and potential acquisitions. The company's outlook anticipates continued expenses and minimal positive or negative net cash flows from operations for the near future, with existing resources expected to fund operations into 2029, excluding PRV sale proceeds.