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Mar 31, 2021
Avadel Q1 2021 Earnings Report
Announced first quarter results with no revenue reported due to the sale of sterile injectable products. R&D expenses decreased, while SG&A expenses increased. Net loss and diluted loss per share increased due to the decrease in revenue.
Key Takeaways
Avadel Pharmaceuticals reported its Q1 2021 financial results with no revenue due to the sale of its sterile injectable products. The company's net loss increased to $13.4 million, or ($0.23) per diluted share. The company is focused on the development and potential launch of FT218.
FDA accepted the NDA filing for once-nightly FT218 with a PDUFA target action date of October 15th.
Richard Kim was appointed as Chief Commercial Officer to lead the launch of FT218, if approved.
Positive secondary endpoint data for FT218 presented at the AAN annual meeting showed improvement in narcolepsy symptoms.
Net loss for the quarter ended March 31, 2021 was $13.4 million, or ($0.23) per diluted share.
Avadel
Avadel
Forward Guidance
This press release includes forward-looking statements regarding the FDA’s review of the NDA for FT218, the sufficiency of data supporting the NDA for FT218, the presentation of additional clinical trial data for FT218, the commercial launch of FT218 (if approved), the market acceptance of FT218 (if approved), and the advancement of the RESTORE study to generate long-term safety, tolerability, and efficacy data for FT218.
Positive Outlook
- FDA acceptance of the NDA filing for once-nightly FT218
- PDUFA target action date of October 15th
- Appointment of Richard Kim as Chief Commercial Officer
- Positive secondary endpoint data for FT218
- Advancement of the RESTORE study
Challenges Ahead
- Risk that positive results from the REST-ON trial may not be predictive of future studies
- Risk that the NDA for FT218 is not approved or is delayed
- Risk that commercial launch of FT218 is delayed or never occurs
- Risk that market acceptance of FT218 may differ materially from projections
- Risk that the RESTORE study may be delayed or not completed