Company: ZVRA
Filing Date: 2025-08-12
Form Type: 10-Q
Source: 0001628280-25-039967
Chunk: 124

Company: ZEVRA THERAPEUTICS, INC.
Filing Date: 2025-08-12
Form: 10-Q
Item: Part I, Item 8
Chunk 124
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 prescription medicine used along with certain therapy, including changes in diet, for the long-term management of adults and children with certain UCDs. For the three and six months ended June 30, 2025, sales of OLPRUVA were $0.3 million and $0.4 million, respectively. For the three and six months ended June 30, 2024, sales of OLPRUVA were de minimis. On September 20, 2024, the FDA approved MIPLYFFA (arimoclomol), an orally-delivered treatment for NPC, which is an ultra-rare and progressive neurodegenerative disease, for treatment in combination with miglustat. For the three and six months ended June 30, 2025, sales of MIPLYFFA were $21.5 million and $38.6 million, respectively. The Company currently utilizes a single specialty pharmacy provider as its sole distributor for both MIPLYFFA and OLPRUVA. The Company also enters into arrangements with health care providers and payors that provide for government mandated and/or privately negotiated rebates with respect to the purchase of its products. To commercialize MIPLYFFA and OLPRUVA in the U.S., the Company has built marketing, sales, medical affairs, distribution, managerial and other non-technical capabilities or is making arrangements with third parties to perform these services. All revenues derived from sales of MIPLYFFA and OLPRUVA are in the United States. Arimoclomol French ACFor the three and six months ended June 30, 2025, the Company recognized revenue related to the French AC of $2.6 million and $5.0 million, respectively, net of a clawback liability of $1.6 million and $3.0 million, respectively, and other gross to net adjustments. For the three and six months ended June 30, 2024, the Company recognized revenue related to the French AC of $3.1 million and $5.4 million, respectively, net of a clawback liability of $1.7 million and $3.0 million, respectively, and other gross to net adjustments.The total estimated reserve liability as of June 30, 2025, and December 31, 2024, was $17.5 million and $12.6 million, respectively. As of June 30, 2025, and December 31, 2024, this estimated reserve liability is recorded