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Jun 30, 2023
Zevra Q2 2023 Earnings Report
Reported corporate updates and financial results for the second quarter of 2023.
Key Takeaways
Zevra Therapeutics reported net revenue of $8.5 million for Q2 2023, driven by AZSTARYS milestone revenues, ongoing royalties from AZSTARYS, and the French early access program for arimoclomol. The company ended the quarter with $87.4 million in cash, cash equivalents, and investments.
Completed a collaborative and productive pre-submission meeting with the FDA for arimoclomol NDA in August 2023, with filing expected in Q4 2023.
Net revenue for Q2 2023 was $8.5 million, including a $5 million milestone payment from the AZSTARYS® license agreement.
Ended Q2 2023 with $87.4 million in cash, cash equivalents, and investments, supporting the forecasted cash runway into 2026.
Expanded the clinical program for KP1077 by opening an Investigational New Drug Application (IND) for narcolepsy.
Forward Guidance
Zevra Therapeutics anticipates resubmitting the arimoclomol NDA package by the end of this year and is on track with the KP1077 program. The company expects to potentially earn a second net sales milestone in 2023.
Positive Outlook
- Arimoclomol NDA resubmission anticipated by the end of the year.
- KP1077 program is on track.
- Potential to earn a second net sales milestone in 2023.
- Focus on developing and commercializing therapies for rare diseases.
- Strong balance sheet to support operations into 2026.
Challenges Ahead
- Ongoing search for a new chief executive officer.
- Ongoing search for an additional replacement Board member.
- Decrease in cash, cash equivalents, and investments compared to the previous quarter.
- Increased third-party R&D costs related to the KP1077 clinical trial program and the arimoclomol program.
Historical Earnings Impact
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