Avadel Pharmaceuticals Reports Strong Financial Results

By Tamara Parker • Monday, March 04 15:24 • Permanent Link

Avadel Pharmaceuticals, a biopharmaceutical company, has reported its fourth-quarter and full-year 2023 financial results in a recent corporate update. The company generated $19.5 million in net revenue from sales of Lumryz™ in the fourth quarter and $28.0 million for the full year 2023.

By the end of January 2024, over 2,200 patients were enrolled in Ryzu™, and more than 1,200 patients had initiated therapy with Lumryz. Avadel has secured payer coverage for over 80% of commercially covered lives for Lumryz, including listings with United Healthcare and Anthem.

The U.S. Food and Drug Administration (FDA) has set a target action date of September 7, 2024, for the supplemental new drug application (SNDA) for Lumryz in pediatric narcolepsy.

In terms of financial performance, Avadel recognized $19.5 million and $28.0 million in net product revenue for the fourth quarter and full year 2023, respectively. Research and development (R&D) expenses decreased to $2.4 million and $13.3 million for the quarter and year ended December 31, 2023, from $6.2 million and $20.7 million for the same periods in 2022.

Selling, general, and administrative (SG&A) expenses increased to $41.3 million and $151.7 million for the quarter and year ended December 31, 2023, from $17.0 million and $74.5 million for the same periods in 2022. The net losses for the quarter and year ended December 31, 2023, were $28.8 million and $160.3 million, respectively.

As of December 31, 2023, Avadel had cash, cash equivalents, and marketable securities totaling $105.1 million.

The company plans to host a conference call at 7:30 a.m. ET to discuss these results and provide further insights.

Lumryz, an extended-release sodium oxybate medication, was approved by the FDA as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. The FDA approval was supported by results from the REST-ON trial, demonstrating statistically significant and clinically meaningful improvements in various endpoints.

The market has reacted to these announcements by moving the company's shares 11.2% to a price of $15.25. Check out the company's full 8-K submission here.

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