Avadel Pharmaceuticals plc · Q3 2022 earnings

Briefing

Announced third quarter financial results and provided a corporate update.

Avadel Pharmaceuticals reported its Q3 2022 financial results with a net loss of $20.1 million. The company is preparing for the commercial launch of LUMRYZ, expected no later than Q3 2023, and is working to potentially accelerate its final approval. Cash, cash equivalents and marketable securities were $106.5 million as of September 30, 2022.

• LUMRYZ granted tentative approval on July 18, confirming its safety profile and clinical efficacy
• Final approval decision of LUMRYZ expected by June 2023; advancing strategy to potentially accelerate final approval
• Commercial launch planned for no later than Q3 2023; launch preparations underway
• Updated RESTORE data demonstrates 94% of switch patients prefer once-at-bedtime LUMRYZ dosing regimen

Headline financials

Revenue & EPS history

The company focuses on the timing of FDA’s final approval decision for LUMRYZ, efforts to accelerate the FDA’s final approval decision, preparations to accelerate the timing between a potential final approval of LUMRYZ and commercial launch as well as the expected results thereof, the estimated once-at-bedtime oxybate market and anticipated market acceptance of LUMRYZ, the continued advancement of the RESTORE study to generate long-term safety, tolerability, and efficacy data for LUMRYZ, the company’s cash runway and anticipated uses of capital, and the expected maturity of the company’s convertible debt.