Company: ZVRA
Filing Date: 2025-11-05
Form Type: 10-Q
Source: 0001434647-25-000011
Chunk: 71

Company: ZEVRA THERAPEUTICS, INC.
Filing Date: 2025-11-05
Form: 10-Q
Item: Part I, Item 1
Chunk 71
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 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 has made arrangements with third parties to perform these services. All revenues derived from sales of MIPLYFFA and OLPRUVA are in the United States. Adjustments to product revenue recognized as a result of changes in estimates for discounts and allowances for products shipped in previous periods were 4% and 1% of revenue, net, on the unaudited condensed consolidated statements of operations during the three and nine months ended September 30, 2025, respectively. No adjustments to product revenue were recognized as a result of changes in estimates during the three and nine months ended September 30, 2024.Arimoclomol French ACFor the three and nine months ended September 30, 2025, the Company recognized revenue related to the French AC of $2.4 million and $7.3 million, respectively, net of a clawback liability of $1.5 million and $4.5 million, respectively, and other gross to net adjustments. For the three and nine months ended September 30, 2024, the Company recognized revenue related to the French AC of 

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$2.6 million and $8.0 million, respectively, net of a clawback liability of $1.4 million and $4.4 million, respectively, and other gross to net adjustments.The total estimated reserve liability as of September 30, 2025, and December 31, 2024, was $18.9 million and $12.6 million, respectively. As of September 30, 2025, and December 31, 2024, this estimated reserve liability is recorded as discount and rebate liabilities in the unaudited condensed consolidated balance sheets and is separated into current and long-term based upon the timing of the expected payment to the French regulators.AZSTARYS License AgreementThe Company entered into a Collaboration and License Agreement (the “AZSTARYS License Agreement”) with Commave Therapeutics SA (formerly known as Boston Pharmaceuticals Holdings SA) (“Commave”), an affiliate of Gurnet Point Capital, L.P., dated September 3, 2019. Under the AZSTARYS License Agreement, as amended, the Company granted to Commave an exclusive, worldwide