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Mar 31, 2020
Zevra Q1 2020 Earnings Report
Reported financial results for the first quarter ended March 31, 2020.
Key Takeaways
KemPharm reported Q1 2020 revenue of $2.1 million from research and development services, and a net loss of $5.8 million, or $0.12 per share. The FDA's acceptance of the KP415 NDA triggered a $5 million milestone payment from GPC.
KP415 NDA filing accepted by FDA on May 1, 2020.
KemPharm entitled to receive $5 million milestone payment from GPC.
Corium, a portfolio company of GPC, will lead all commercialization activities for KP415.
Anticipate a potential action (PDUFA) date for KP415 in March 2021.
Zevra
Zevra
Forward Guidance
KemPharm expects to continue to earn revenue as the Company provides services to its partners under the License Agreement through the remainder of 2020 and into 2021. Based on the Company’s current operating forecast, expected revenues and existing resources are sufficient to continue operations into, but not through March 2021.
Positive Outlook
- Continuing services revenue expected through 2020 and into 2021.
- Improved expense base.
- Completed the first phase of restructuring of 2020 debt obligations.
- $5 million regulatory milestone earned under the License Agreement.
- Cash runway extended past the potential PDUFA date for the KP415 NDA.
Challenges Ahead
- Has not regained compliance with the market value of listed securities (MVLS) continued listing requirement for the NCM.
- Has not regained compliance with the minimum bid price (“Bid Price”) of listed securities requirement for continued listing.
- If the Company fails to demonstrate compliance with the MVLS continued listing requirement of $35 million for the NCM on or before May 13, 2020, it is likely that Nasdaq will issue a final delist determination and suspend the Company from trading on Nasdaq.
- Based on the Company’s current operating forecast, expected revenues and existing resources are sufficient to continue operations into, but not through March 2021.
- Continuing to work with financial advisors to complete the second phase of debt restructuring, which we will seek to complete, if possible, prior to the potential approval of the KP415 NDA.