Avadel Pharmaceuticals plc (Nasdaq: AVDL) has announced preliminary 2024 results and outlined its commercial priorities for 2025, emphasizing the continued growth and market penetration of LUMRYZ™ (sodium oxybate) for extended-release oral suspension. The company's strategic focus is on transforming medicines to transform lives, particularly for patients with sleep disorders.
Financial Highlights and Growth
Avadel reported impressive financial results for the fourth quarter of 2024, with net product revenue from LUMRYZ estimated at approximately $50.0 million. This represents a greater than 150% increase compared to the $19.5 million reported for the same period in 2023. Full-year net product revenue reached approximately $169.0 million, a substantial increase from $28.0 million in 2023. The company also reported positive cash flow during the fourth quarter, ending with approximately $73.0 million in cash, cash equivalents, and marketable securities as of December 31, 2024.
Commercial Strategy and Patient Adoption
As of December 31, 2024, 2,500 patients were on LUMRYZ, reflecting a more than 275% increase compared to 900 patients as of December 31, 2023. In the fourth quarter alone, 600 patients initiated therapy. Demand for LUMRYZ continues to come from all three patient segments: those switching from first-generation oxybates (38%), those new to oxybate treatment (34%), and those who have previously tried and discontinued oxybates (28%). Approximately 74% of patients on therapy were reimbursed as of December 31, 2024.
To further accelerate LUMRYZ's reach and improve persistency, Avadel has made several commercial investments, including:
- Expanding and upgrading the field sales team by nearly 15% to broaden physician reach.
- Doubling the field reimbursement team to accelerate patient fulfillment.
- Expanding patient ambassador direct-to-patient initiatives to educate and activate oxybate patients.
- Progressing field-based patient support services to provide more personal intervention at the patient and physician office level.
2025 Guidance and Pipeline Updates
Avadel anticipates net product revenue in the range of $240 to $260 million for 2025, representing a 50% increase at the midpoint of guidance from 2024. The company also projects cash flow of $20 to $40 million, with 2,800 to 3,000 patients initiating therapy and 3,300 to 3,500 total patients on therapy by December 31, 2025.
Patient enrollment is ongoing in the REVITALYZ pivotal study, a Phase 3 double-blind, placebo-controlled, randomized withdrawal, multicenter study designed to evaluate the efficacy and safety of LUMRYZ in idiopathic hypersomnia (IH). Completion of this study is expected during the second half of 2025. Additionally, preclinical development is ongoing for a once-nightly, low-/no-sodium oxybate formulation with a target product profile bioequivalent to LUMRYZ.
Management Commentary
"2024 was a pivotal year for Avadel, marked by consistent patient adoption of LUMRYZ and overwhelmingly positive feedback from both patients and providers about the transformative benefits of once-nightly dosing," said Greg Divis, Chief Executive Officer of Avadel Pharmaceuticals. "As we move into 2025, we are building on this momentum with a refined commercial strategy to increase demand for and persistency on, LUMRYZ, with the primary goal of enhancing the overall LUMRYZ experience for both patients and providers. We believe the strategic initiatives we're introducing now will drive uptake among each of the three narcolepsy patient segments – switches, new to oxybates, and previously treated and discontinued – and allow us to further unlock the market potential of LUMRYZ. With the continued execution of our commercial launch in narcolepsy and ongoing progress in our Phase 3 trial in idiopathic hypersomnia (IH), we are well positioned to solidify our leadership in the sleep space and transform care for patients with sleep disorders."
