Avadel Pharmaceuticals PLC Reports Q3 2023 Financial Results with Strong LUMRYZ™ Launch

Significant Milestones Achieved in Narcolepsy Treatment and Financial Position Strengthened

Summary
  • Avadel Pharmaceuticals PLC (AVDL) reports $7.0 million in net revenue from the U.S. launch of LUMRYZ™.
  • Over 1,000 patients enrolled in RYZUPTM program, with more than 400 initiating therapy as of September 30, 2023.
  • LUMRYZ™ to gain preferred status on CVS commercial formularies starting January 1, 2024.
  • Net loss for Q3 2023 was $36.3 million, with a significant increase in SG&A expenses due to launch activities.
Article's Main Image

On November 8, 2023, Avadel Pharmaceuticals PLC (AVDL, Financial) provided a corporate update and announced its financial results for the third quarter ended September 30, 2023. The company reported a robust launch of its narcolepsy treatment, LUMRYZ™, which generated $7.0 million in net revenue since its U.S. commercial launch on June 5, 2023. Avadel Pharmaceuticals PLC (AVDL) has seen a strong demand for LUMRYZ™, with over 1,000 patients enrolled in the RYZUPTM program and more than 400 patients initiating therapy by the end of the quarter.

Financial Highlights and Performance

Avadel Pharmaceuticals PLC (AVDL, Financial) recognized $7.0 million in net product revenue for the quarter, exclusively from LUMRYZ™ sales. Research and Development (R&D) expenses were slightly down to $2.8 million compared to $2.9 million for the same period in 2022. However, Selling, General & Administrative (SG&A) expenses saw a significant increase to $39.2 million, up from $14.1 million in the same quarter of the previous year, driven by higher compensation costs due to increased headcount, selling, marketing, and launch-related activities, as well as higher legal fees.

The net loss for the quarter was $36.3 million, or ($0.41) per diluted share, compared to a net loss of $20.1 million, or ($0.33) per diluted share, for the same period in 2022. The company's cash position remains strong, with cash, cash equivalents, and marketable securities totaling $153.2 million as of September 30, 2023. This includes the first $30.0 million tranche from a $75.0 million royalty financing arrangement drawn on August 1, 2023. Subsequent to the quarter's end, Avadel Pharmaceuticals PLC (AVDL, Financial) paid off the remaining $21.2 million of convertible notes.

Operational and Clinical Progress

Avadel Pharmaceuticals PLC (AVDL, Financial) has submitted a supplemental New Drug Application (sNDA) for LUMRYZ™ in the pediatric narcolepsy population on November 7th, which, if approved, will expand the treatment's reach. The company's CEO, Greg Divis, expressed satisfaction with the launch's progress and the positive reception from the narcolepsy community.

We are very pleased with the significant progress we made during the first full quarter of the launch of LUMRYZ, underscored by the early patient demand and the overwhelmingly positive feedback received from across the narcolepsy community,"
said Greg Divis.

Furthermore, the company announced that LUMRYZ™ will be added to a preferred position for CVS commercial formularies effective January 1, 2024, which is expected to enhance the treatment's market availability and demand.

Conclusion

Avadel Pharmaceuticals PLC (AVDL, Financial) has made significant strides in the third quarter of 2023, marked by the successful launch of LUMRYZ™ and the expansion of its patient reach. The financial results reflect the company's investment in the product's launch and market penetration. With a solid cash position and strategic moves to secure preferred formulary status, Avadel Pharmaceuticals PLC (AVDL) is poised to continue its growth trajectory in the narcolepsy treatment market.

For detailed financial tables and further information, readers are encouraged to view the full earnings release on Avadel Pharmaceuticals PLC (AVDL, Financial)'s website.

Explore the complete 8-K earnings release (here) from Avadel Pharmaceuticals PLC for further details.