Company: ZVRA
Filing Date: 2025-11-05
Form Type: 10-Q
Source: 0001434647-25-000011
Chunk: 131

Company: ZEVRA THERAPEUTICS, INC.
Filing Date: 2025-11-05
Form: 10-Q
Item: Part I, Item 8
Chunk 131
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% 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 license to develop, manufacture and commercialize the Company’s product candidates containing SDX and d-MPH, including AZSTARYS, or any other product candidates containing SDX and developed to treat ADHD or any other central nervous system disorder. Corium Inc. was tasked by Commave to lead all commercialization activities for AZSTARYS under the AZSTARYS License Agreement. Pursuant to the AZSTARYS License Agreement, Commave agreed to pay milestone payments up to an aggregate of $590.0 million upon the occurrence of specified regulatory milestones related to AZSTARYS