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Jun 30, 2021
Avadel Q2 2021 Earnings Report
Reported financial results for the second quarter ended June 30, 2021.
Key Takeaways
Avadel Pharmaceuticals reported no revenue for Q2 2021 due to the sale of sterile injectable products in June 2020. R&D expenses increased to $6.8 million, and SG&A expenses rose to $15.2 million. The company had a net loss of $19.6 million, or ($0.33) per diluted share. Cash, cash equivalents, and marketable securities totaled $202.8 million as of June 30, 2021.
Advanced FT218, a once-at-bedtime option for managing EDS and cataplexy in adult patients with narcolepsy.
Presented data at SLEEP 2021 demonstrating the additional benefit of consolidating sleep.
NDA review is in the final stages with an October PDUFA date.
Commercial and launch preparations are on track, including the addition of key hires to the leadership team.
Avadel
Avadel
Forward Guidance
Avadel Pharmaceuticals is focused on the FDA approval and commercial launch of FT218 for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.
Positive Outlook
- Potential approval of FT218
- Advancing FT218
- Commercial and launch preparations are on track
- Addition of key hires to leadership team
- RESTORE study on patient preference
Challenges Ahead
- Risk that REST-ON trial may not be predictive
- Risk that NDA for FT218 is not approved
- Risk that commercial launch of FT218 is delayed
- Risk that market acceptance of FT218 may differ from projections
- Risk that FT218 may be found to infringe patents