Company: ZVRA
Filing Date: 2025-05-13
Form Type: 10-Q
Source: 0001437749-25-016523
Chunk: 85

Company: ZEVRA THERAPEUTICS, INC.
Filing Date: 2025-05-13
Form: 10-Q
Item: Part I, Item 1
Chunk 85
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 and children with certain UCDs weighing 
        44 pounds (
        20 kg) or greater and with a body surface area of 
        1.2m
        2 or greater. For the
        three months ended
         March 31, 2025, and
        2024, sales of OLPRUVA were
        $0.1 million and de minimis, respectively. 

        On  September 20, 2024, the NDA for MIPLYFFA, an orally-delivered treatment for NPC, which is an ultra-rare and progressive neurodegenerative disease, was approved for treatment in combination with miglustat. In addition, the Company received a transferable rare pediatric disease PRV in conjunction with the approval of MIPLYFFA. On  April 1, 2025, the Company consummated the sale of the PRV, resulting in net proceeds of $148.3 million to the Company. For the three months ended  March 31, 2025, sales of MIPLYFFA were $17.1 million. 

         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.

              French AC

                       For the
                      three months ended
                       March 31, 2025, and
                      2024, the Company recognized revenue related to the French AC
                      of $2.3 million and 
                      $2.2 million, net of a clawback liability of
                      $1.4 million and 
                      $1.3 million, respectively, and other gross to net adjustments. The total estimated reserve liability as of
                       March 31, 2025, and
                       December 31, 2024, was
                       $14.6 million and
                      $12.6 million