Avadel Pharmaceuticals Q1 2024 Financial Results and Corporate Update

Avadel Pharmaceuticals plc, a biopharmaceutical company, reported its financial results for the quarter ending March 31, 2024, and provided a corporate update. Avadel is focused on transforming medicines to improve lives, with a particular emphasis on treating narcolepsy. The company’s CEO, Greg Divis, highlighted the strong performance of their product LUMRYZ™, which has been positively received by patients, prescribers, and caregivers.

LUMRYZ, an extended-release sodium oxybate, is the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. Since its launch in the U.S. in June 2023, LUMRYZ has seen significant uptake. By March 31, over 1,700 patients had initiated therapy, marking a more than 70% increase from December 31. Additionally, more than 2,800 patients enrolled in Avadel’s RYZUP patient support services, reflecting a roughly 50% increase from the end of last year. The majority of these patients had switched from first-generation oxybates or had previously tried and discontinued those treatments.

Looking to the future, Avadel is pursuing expansion opportunities for LUMRYZ. The U.S. Food and Drug Administration (FDA) has accepted a Supplemental New Drug Application (sNDA) for LUMRYZ to treat pediatric narcolepsy, with a decision expected by September 7, 2024. If approved, this could significantly ease the burden on families needing to administer a second dose to their children in the middle of the night. Pediatric patients currently represent about 5% of all oxybate-treated narcolepsy patients. Additionally, the company plans to initiate a Phase 3 pivotal trial for LUMRYZ in treating idiopathic hypersomnia in the latter half of 2024.

Financially, Avadel reported $27.2 million in net product revenue for the first quarter of 2024, all from LUMRYZ sales. The company’s gross profit for this period was $25.7 million. Research and development (R&D) expenses were $3.1 million, down from $3.8 million during the same period in 2023, primarily due to lower pre-commercial costs for LUMRYZ. Selling, general, and administrative (SG&A) expenses were $48.6 million, up from $24.5 million in the previous year, driven by costs related to the commercial launch of LUMRYZ, increased headcount, higher selling and marketing activities, and legal fees. Avadel posted a net loss of $27.3 million, or ($0.30) per diluted share, compared to a loss of $30.8 million, or ($0.48) per diluted share, in the same quarter of 2023.

As of March 31, 2024, Avadel had $88.8 million in cash, cash equivalents, and marketable securities. The company is well-positioned financially to continue its growth and expansion activities.

In addition to providing the financial update, Avadel also hosted a conference call to discuss these results and future plans. The call was accessible via dial-in numbers and a live audio webcast on the company’s website.

LUMRYZ, approved by the FDA on May 1, 2023, has shown significant improvements in treating cataplexy and EDS in adults with narcolepsy. The approval was based on the successful results of the REST-ON trial, a pivotal Phase 3 study. The FDA granted LUMRYZ seven years of Orphan Drug Exclusivity due to its clinical superiority over existing twice-nightly oxybate treatments, mainly due to its once-nightly dosing regimen.

Overall, Avadel Pharmaceuticals is focused on leveraging its innovative solutions to improve patient care, particularly in the narcolepsy market, and is exploring further opportunities for LUMRYZ in pediatric narcolepsy and idiopathic hypersomnia.