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Mar 31, 2021
Zevra Q1 2021 Earnings Report
KemPharm's Q1 2021 financial results were reported, marked by significant achievements including FDA approval of AZSTARYS and a completed financial restructuring.
Key Takeaways
KemPharm reported a transformational first quarter of 2021 with the FDA approval of AZSTARYS, completion of financial restructuring, and re-listing on Nasdaq. The company reported revenue of $12.1 million and a net loss of $0.54 per share.
AZSTARYS NDA was approved by the FDA on March 2, 2021.
Amendment to Licensing Agreement with Gurnet Point Capital affiliate was announced following FDA approval of AZSTARYS.
FDA clearance was received to initiate KP879 clinical program for the treatment of Stimulant Use Disorder.
Serdexmethylphenidate (SDX) was classified as a Schedule IV Controlled Substance by the DEA.
Zevra
Zevra
Forward Guidance
KemPharm has emerged from Q1 2021 as a Nasdaq-listed company with no debt and significant cash holdings on the balance sheet.
Positive Outlook
- KemPharm has the resources needed to continue the development of KP879
- Significant cash holdings on the balance sheet
- No debt
- Evaluating how to efficiently deploy capital to generate additional value streams for shareholders.
- Creating long-term value is top of mind