Core Insights - Avadel Pharmaceuticals presented new data on LUMRYZ, a once-nightly sodium oxybate treatment for narcolepsy, at World Sleep 2025, highlighting its efficacy in improving symptoms for both new and returning patients [1][2][3] Group 1: Efficacy of LUMRYZ - The REFRESH study demonstrated that patients switching from twice-nightly oxybate to LUMRYZ experienced clinically meaningful improvements in excessive daytime sleepiness (EDS) and other narcolepsy symptoms [4] - 70% of switch participants and 90% of non-switch participants reported improvement on the Patient Global Impression of Change after 4 months of therapy [4] - The study also indicated a reduction in severity of narcolepsy symptoms from moderate to mild, with significant improvements in quality of life metrics such as fatigue, brain fog, and mood [4] Group 2: Presentation Highlights - A total of 17 abstracts were accepted for presentation at World Sleep 2025, including one oral presentation and 16 posters, focusing on the benefits of LUMRYZ [1][2] - Presentations reinforced the advantages of LUMRYZ in addressing hallmark symptoms of narcolepsy, including EDS and sleep-related hallucinations [3] Group 3: Regulatory and Market Position - LUMRYZ is the first and only once-at-bedtime treatment for cataplexy or EDS in patients aged seven years and older with narcolepsy, receiving FDA approval in May 2023 and October 2024 [8][10] - The FDA granted LUMRYZ seven years of Orphan Drug Exclusivity due to its clinical superiority over existing treatments, emphasizing its once-nightly dosing regimen [10]

Financial Performance - Generated net product revenue of $68.1 million from sales of LUMRYZ, representing a 64% increase compared to $41.5 million for the same period in 2024 [6][10] - Achieved net income of $9.7 million, or $0.10 per diluted share, compared to a net loss of $13.8 million, or ($0.14) per diluted share, for the same period in 2024 [12][10] - Positive cash flow in the quarter ended June 30, 2025, with cash, cash equivalents, and marketable securities increasing by $15.0 million compared to March 31, 2025 [13][6] Patient Growth and Market Position - As of June 30, 2025, 3,100 patients were being treated with LUMRYZ, a 63% increase compared to 1,900 patients as of June 30, 2024 [6][3] - The company raised its full-year revenue guidance for 2025 to a range of $265 - $275 million [6][3] Regulatory and Clinical Developments - Received Orphan Drug Designation from the FDA for LUMRYZ for the treatment of Idiopathic Hypersomnia (IH) [6][3] - On track to complete enrollment in the pivotal Phase 3 REVITALYZ study evaluating the efficacy and safety of LUMRYZ in IH by the end of 2025 [6][3] Corporate Updates - Appointed Susan Rodriguez as Chief Operating Officer to oversee commercial strategy, operations, and supply chain [6][3] - The U.S. Court of Appeals affirmed the FDA's approval of LUMRYZ for patients seven years of age and older with narcolepsy, noting its clinical superiority [7][6]

Core Insights - Avadel Pharmaceuticals is presenting new data on LUMRYZ, a treatment for narcolepsy, at the SLEEP 2025 conference, highlighting its efficacy and real-world impact on patients [1][2][3] Group 1: Efficacy and Clinical Data - Interim analysis of the REFRESH study shows significant improvement in excessive daytime sleepiness (EDS) for patients switching from twice-nightly oxybate to once-at-bedtime LUMRYZ [1][2] - Post-hoc analysis from the Phase 3 REST-ON trial indicates that LUMRYZ participants with severe sleepiness achieved median Epworth Sleepiness Scale (ESS) scores within the normal range by Week 13 [2][3] - Data from the REFRESH study indicates that 67 patients, including those new to oxybate and those switching from twice-nightly oxybate, experienced clinically significant reductions in sleepiness [3][4] Group 2: Safety and Tolerability - A post-hoc analysis from the RESTORE study involving 115 participants showed that only 4% discontinued LUMRYZ due to treatment-related adverse events, indicating long-term tolerability [3][4] - The safety profile of LUMRYZ aligns with known adverse events of oxybates, with no worsening of apnea-hypopnea index (AHI) observed in patients with mild sleep apnea [2][3] Group 3: Regulatory and Market Position - LUMRYZ received FDA approval as the first and only once-at-bedtime treatment for cataplexy or EDS in adults and pediatric patients with narcolepsy, supported by significant clinical trial results [6][7][8] - The FDA granted LUMRYZ 7 years of Orphan Drug Exclusivity due to its clinical superiority over existing treatments, emphasizing its once-nightly dosing regimen [8][9] Group 4: Conference Presentations - Avadel will present 14 abstracts, including four oral presentations, at SLEEP 2025, focusing on the benefits of LUMRYZ for narcolepsy patients [1][3] - Key presentations will cover topics such as the long-term safety of LUMRYZ, improvements in daytime sleepiness, and the impact on sleep-related eating disorder [4][5]