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Mar 31, 2023
Avadel Q1 2023 Earnings Report
Announced first quarter 2023 financial results and provided a corporate update.
Key Takeaways
Avadel Pharmaceuticals announced FDA approval for LUMRYZ and reported first quarter 2023 financial results. The company secured over $200 million of capital to support the launch of LUMRYZ.
Received FDA approval for LUMRYZ, the first and only once-at-bedtime oxybate for treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.
FDA awarded LUMRYZ Orphan Drug Exclusivity through May 1, 2030.
LUMRYZ product availability on track for early June; market research and physician feedback supports potential to capture a meaningful share of the $3 billion plus once-nightly oxybate market.
Secured over $200 million of capital to support the near-term launch of LUMRYZ.
Avadel
Avadel
Forward Guidance
The company anticipates launching LUMRYZ in early June and expects it to capture a meaningful share of the $3 billion plus once-nightly oxybate market.
Positive Outlook
- Potential therapeutic benefit of LUMRYZ.
- Orphan Drug Exclusivity for LUMRYZ and potential benefits resulting from such designation.
- Preparation and timing of commercial launch and the success of such commercialization for LUMRYZ.
- Expectations regarding the potential market impact of LUMRYZ.
- The anticipated market availability of LUMRYZ.
Challenges Ahead
- Risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022
- The company's business and operations are subject to significant risks.
- There can be no assurance that actual results and the results of the company’s business and operations will not differ materially from the results contemplated in such forward-looking statements.
- Factors that could cause actual results to differ from expectations in the Company’s forward-looking statements.
- Forward-looking statements speak only as of the date they are made and are not guarantees of future performance.