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Zevra Therapeutics (ZVRA) investor relations material

Zevra Therapeutics Q3 2025 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q3 2025 earnings summary5 Nov, 2025

Executive summary

  • Q3 2025 net revenue reached $26.1 million, primarily from Miplyf/MIPLYFFA, with $22.4 million from the product and significant year-over-year growth from $3.7 million in Q3 2024.

  • Achieved FDA approval and commercial launch of Miplyf/MIPLYFFA for Niemann-Pick Disease Type C, with $61.0 million in sales for the nine months ended September 30, 2025.

  • Net loss for Q3 2025 was $0.5 million ($0.01 per share), a substantial improvement from a $33.2 million loss in Q3 2024.

  • Cash, cash equivalents, and investments totaled $230.4 million as of September 30, 2025, supporting strategic priorities and operational runway.

  • Completed sale of a rare pediatric disease priority review voucher for $148.3 million, significantly boosting net income.

Financial highlights

  • Q3 2025 net revenue: $26.1 million, including $22.4 million from Miplyf/MIPLYFFA, $2.4 million from French EAP, $1.2 million from Astarys royalties, and $0.1 million from Olpruva.

  • Revenue for the nine months ended September 30, 2025, was $72.3 million, up from $11.6 million year-over-year, driven by Miplyf/MIPLYFFA sales.

  • Net income for the nine months was $71.1 million, compared to a net loss of $69.8 million in the prior year period.

  • Operating expenses decreased to $20.4 million in Q3 2025; R&D expenses down to $3.4 million; SG&A up to $16.9 million.

  • Cost of product revenue was $1.2 million in Q3 2025, down from $2.3 million in Q3 2024.

Outlook and guidance

  • Confident in financial resources to execute strategic priorities without additional capital market needs.

  • Ongoing investments in Miplyf/MIPLYFFA U.S. launch, European expansion, and late-stage pipeline assets.

  • Management expects continued revenue growth from Miplyf/MIPLYFFA and Olpruva, with additional upside from European expansion and pipeline progress.

  • No major changes anticipated in selling expenses despite scaling back Apruva/OLPRUVA promotion.

  • Focus remains on disease awareness, patient identification, and payer coverage to drive future growth.

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Guggenheim Securities 2nd Annual Healthcare Innovation Conference12 Nov, 2025
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Frequently asked questions

Zevra Therapeutics Inc., previously known as KemPharm Inc., is a biopharmaceutical company specializing in the development of proprietary prodrugs for the treatment of serious medical conditions, with a focus on rare diseases. The company utilizes its Ligand Activated Therapy technology to create enhanced versions of FDA-approved drugs and new compounds for potential new disease indications. Zevra's product pipeline includes KP1077, designed for the treatment of idiopathic hypersomnia (IH) and narcolepsy, and KP879 for stimulant use disorder, both in Phase II clinical trials. Additionally, Zevra has FDA-approved products like AZSTARYS for attention deficit hyperactivity disorder and APADAZ, a combination treatment containing a prodrug of hydrocodone and acetaminophen. The company is headquartered in Celebration, Florida, and its shares are listed on the NASDAQ.

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