Avadel Pharmaceuticals Announces Strong LUMRYZ Launch Performance and Provides Preliminary Fourth Quarter and Full Year 2023 Financial Highlights

-- Approximately $19 million and $28 million of net revenue from sales of LUMRYZ estimated for the fourth quarter and full year 2023, respectively --

-- Generated continued robust demand for LUMRYZ with greater than 1,900 patients enrolled in RYZUP^TM and more than 1,000 patients initiating therapy through December 31 --

-- Signed Emisar (Optum Rx GPO) contract, all 3 PBM owned GPO contracts now finalized for 2024 --

-- Supplemental New Drug Application (sNDA) for LUMRYZ in the pediatric narcolepsy population accepted by FDA; approval decision expected in September 2024 --

DUBLIN, Ireland, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today provided a business update including preliminary estimates of fourth quarter and full year net revenue and cash, cash equivalents and marketable securities.

“2023 was transformational for Avadel defined by significant growth and continued execution of milestones critical to Avadel’s success, beginning with the FDA approval and receipt of Orphan Drug Exclusivity for LUMRYZ. The LUMRYZ launch has thus far been marked by robust demand and overwhelmingly positive feedback from the narcolepsy community, health care providers and payers. Our team is proud of the momentum built this year, and looking toward 2024, we are excited to see LUMRYZ’s continued impact across the narcolepsy community,” said Greg Divis, Chief Executive Officer of Avadel Pharmaceuticals.

Launch Progress Through December 31, 2023:

• Greater than 1,900 patients enrolled in Avadel’s RYZUP patient support services:
  • More than 1,000 patients initiated therapy.
  • The majority of RYZUP enrollments and patients currently being treated with LUMRYZ are patients who switched from first generation oxybates, with the balance made up of patients who previously tried and discontinued a first generation oxybate and patients who are new to oxybate treatment.
• Signed contract with Emisar (Optum Rx GPO) 
  • Contracts now in place with all 3 PBM owned GPOs (Ascent/ESI, Zinc/CVS and Emisar/Optum).
  • LUMRYZ moved to preferred status within the CVS commercial formularies and Optum Select as of January 1, 2024.
• Nearly 1,800 health care providers have completed the LUMRYZ REMS certification process, including both experienced oxybate prescribers as well as providers who have never previously prescribed an oxybate.