Zevra Q1 2024 Earnings Report
Key Takeaways
Zevra Therapeutics reported a net revenue of $3.4 million for Q1 2024, compared to $3.2 million in Q1 2023. The net loss for Q1 2024 was $16.6 million, or $0.40 per share, compared to a net loss of $13.2 million, or $0.38 per share for Q1 2023. The company's cash, cash equivalents, and investments totaled $52.7 million as of March 31, 2024.
OLPRUVA had its full commercial launch at the end of January 2024, reaching ~75% of covered lives by May 1, 2024.
The FDA is reviewing the arimoclomol NDA with a PDUFA date of September 21, 2024.
Positive topline results were reported from the KP1077 Phase 2 Trial in idiopathic hypersomnia, with full data to be presented at SLEEP 2024 in early June 2024.
Zevra refinanced its debt, securing up to $100 million in committed capital.
Zevra
Zevra
Forward Guidance
Zevra expects available cash, cash equivalents and investments to extend the cash runway into 2026, subject to continuing compliance with debt covenants. The forecast includes revenue from OLPRUVA sales, French EAP reimbursements for arimoclomol, and royalties from the AZSTARYS license agreement.
Positive Outlook
- Revenue from the expected sales of OLPRUVA.
- Ongoing reimbursements from the French EAP for arimoclomol.
- Ongoing royalties under the AZSTARYS license agreement.
- Investments into the incremental commercial activities needed to support the launch of arimoclomol, if approved.
- Completion of the KP1077 development program for IH.
Challenges Ahead
- Continuing compliance with debt covenants.
- The forecast does not include any commercial revenue from arimoclomol which could follow a potential FDA approval.
- The forecast does not include the potential sale of the Priority Review Voucher which would be received upon approval.
- Potential delays in the KP1077 development program.
- Uncertainties related to commercial activities needed to support the launch of arimoclomol.