Avadel Pharmaceuticals PLC
NASDAQ:AVDL
Avadel Pharmaceuticals PLC
Avadel Pharmaceuticals Plc engages in the development and commercialization of pharmaceutical products. The company is headquartered in Dublin, Dublin and currently employs 66 full-time employees. The Company’s lead product candidate, FT218, is an investigational once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness (EDS), and cataplexy in narcolepsy patients. Its Micropump allows for the development of modified and/or controlled release solid, oral dosage formulations of drugs. Its LiquiTime technology allows for development of modified/controlled release oral products in a liquid suspension formulation, which may make such formulations particularly suited for children and/or patients having issues swallowing tablets or capsules. Its Medusa technology allows for the development of extended-/modified-release injectable dosage formulations of drugs.
Avadel Pharmaceuticals Plc engages in the development and commercialization of pharmaceutical products. The company is headquartered in Dublin, Dublin and currently employs 66 full-time employees. The Company’s lead product candidate, FT218, is an investigational once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness (EDS), and cataplexy in narcolepsy patients. Its Micropump allows for the development of modified and/or controlled release solid, oral dosage formulations of drugs. Its LiquiTime technology allows for development of modified/controlled release oral products in a liquid suspension formulation, which may make such formulations particularly suited for children and/or patients having issues swallowing tablets or capsules. Its Medusa technology allows for the development of extended-/modified-release injectable dosage formulations of drugs.
Revenue Growth: LUMRYZ net revenue hit $68.1 million in Q2, up 64% year-over-year and 30% sequentially.
Profitability: Avadel reported its first-ever net income since the LUMRYZ launch, at $9.7 million or $0.10 per diluted share.
Patient Demand: Active LUMRYZ patients grew to approximately 3,100, a 63% increase from last year, with persistency and reimbursement rates improving.
Raised Guidance: Full-year 2025 revenue guidance was raised to $265–275 million from $255–265 million, reflecting confidence in continued commercial execution.
Clinical Expansion: LUMRYZ received orphan drug designation for idiopathic hypersomnia (IH), with Phase III enrollment underway and potential supplemental NDA filing targeted for the second half of 2026.
Ongoing Investments: Avadel is increasing investments in sales, marketing, and new product development, including a low/no sodium extended-release oxybate.
Legal Clarity: A favorable court ruling affirmed FDA approval of LUMRYZ, and Avadel is pursuing additional legal actions with a major antitrust trial scheduled for November.
