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Mar 31, 2023
Zevra Q1 2023 Earnings Report
Zevra reported its financial results for the first quarter of 2023 and provided corporate updates.
Key Takeaways
Zevra Therapeutics reported a net revenue of $2.9 million for Q1 2023, supported by AZSTARYS® royalties and the arimoclomol early access program in France. The company's cash runway is expected to extend into 2026, with $95.3 million in cash, cash equivalents, and investments as of March 31, 2023.
Rebranded Zevra Therapeutics, reinforcing the company's strategic transformation into a commercially focused rare disease company.
Continued advancement of arimoclomol toward resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) anticipated as early as Q3 2023.
Continued advancement of Phase 2 clinical trial evaluating KP1077 as a treatment for IH, with interim efficacy and safety data expected as early as Q3 2023.
Expanded the clinical program for KP1077 by opening an IND for narcolepsy, extending its potential to address multiple rare sleep disorders.
Forward Guidance
The Company’s current operating forecast, existing cash, cash equivalents, and investments are expected to be sufficient to continue operations into 2026.
Positive Outlook
- Remaining activities required to resubmit the arimoclomol NDA.
- Funding of the commercial preparation for potential launch of arimoclomol in the U.S., if approved.
- Completion of the development program for KP1077 in IH.
- Preparation and submission of the NDA.
- Up to the potential PDUFA date.
Historical Earnings Impact
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