Core Insights - Avadel Pharmaceuticals reported approximately $50.0 million in net revenue from LUMRYZ sales for Q4 2024, representing a greater than 150% increase compared to $19.5 million in Q4 2023 [1][5] - The company anticipates LUMRYZ net product revenue to be between $240 million and $260 million in 2025, indicating a 50% year-over-year growth at the midpoint [1][10] - As of December 31, 2024, there were 2,500 patients on LUMRYZ, a more than 275% increase from 900 patients on the same date in 2023 [1][5] Financial Highlights - Full year net product revenue for 2024 is approximately $169.0 million, up from $28.0 million in 2023 [5] - The company ended Q4 2024 with approximately $73.0 million in cash, cash equivalents, and marketable securities [5] - The fourth quarter revenue was impacted by an estimated $6.0 million due to approximately 1.5 fewer weeks of inventory in the channel compared to the previous quarter [5] Patient Adoption and Market Strategy - In Q4 2024, 600 patients initiated therapy with LUMRYZ, contributing to consistent demand across three patient segments: 38% switched from first-generation oxybates, 34% were new to oxybate, and 28% had previously tried and discontinued oxybates [1][5] - Approximately 74% of patients on therapy were reimbursed as of December 31, 2024 [5] - The company has expanded its field sales team by nearly 15% and doubled its field reimbursement team to enhance physician reach and patient fulfillment [5][10] Future Guidance - The company projects a net product revenue range of $240 million to $260 million for 2025, with cash flow expected between $20 million and $40 million [10] - The anticipated number of patients initiating therapy in 2025 is between 2,800 and 3,000, with total patients on therapy expected to reach between 3,300 and 3,500 by December 31, 2025 [10] - Ongoing patient enrollment in the REVITALYZ pivotal study, a Phase 3 trial for idiopathic hypersomnia, is expected to complete in the second half of 2025 [10]

DUBLIN, Jan. 06, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on transforming medicines to transform lives, today announced that the Compensation Committee of Avadel’s Board of Directors approved the grant of non-statutory options to twelve (12) new employees to purchase an aggregate of 131,700 ordinary shares under Avadel’s 2021 Inducement Plan. The awards were granted as an inducement material to the employee’s acceptance of employment with Avadel in accordance wit ...

Company Update - Avadel Pharmaceuticals plc will host a conference call and live webcast on January 8, 2025, at 4:30 p.m. ET to provide a corporate update and discuss preliminary unaudited financial results for Q4 and the full year ended December 31, 2024 [1] - A live audio webcast of the call can be accessed through the investor relations section of the company's website, and a replay will be available for 90 days following the event [2] Company Overview - Avadel Pharmaceuticals plc is a biopharmaceutical company focused on transforming medicines to improve patients' lives [3] - The company's commercial product, LUMRYZ™, is the first and only once-at-bedtime oxybate approved by the FDA for treating cataplexy or excessive daytime sleepiness in patients aged 7 years and older with narcolepsy [3]

Company Overview - Avadel Pharmaceuticals plc is a biopharmaceutical company focused on transforming medicines to improve patients' lives [3] - The company has developed LUMRYZTM, the first and only once-at-bedtime oxybate approved by the U.S. FDA for treating cataplexy or excessive daytime sleepiness in patients aged 7 years and older with narcolepsy [3] Upcoming Events - Members of Avadel's management will participate in a fireside chat at the Jefferies London Healthcare Conference on November 20, 2024, at 7:30 a.m. GMT / 2:30 a.m. ET [1] - A live webcast of the fireside chat will be available on Avadel's Investor Relations website for 90 days following the conference [2]

Avadel Pharmaceuticals plc (NASDAQ:AVDL) Q3 2024 Earnings Conference Call November 12, 2024 8:30 AM ET Company Participants Austin Murtagh - Director, Precision AQ Greg Divis - CEO Richard Kim - CCO Jennifer Gudeman - SVP, Medical & Clinical Affairs Tom McHugh - CFO Conference Call Participants Andrew Tsai - Jefferies François Brisebois - Oppenheimer Oren Livnat - H.C. Wainwright Ami Fadia - Needham David Amsellem - Piper Sandler Operator Good day everyone and welcome to today's Avadel Pharmaceuticals 3Q 20 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ——————— Title of each class Trading Symbol(s) Name of each exchange on which registered Ordinary Shares, nominal value $0.01 per share AVDL The Nasdaq Global Market FORM 10-Q ——————— ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition per ...

Exhibit 99.1 Avadel Pharmaceuticals Provides Corporate Update and Reports Third Quarter 2024 Financial Results -- Generated $50.0 million in net revenue from sales of LUMRYZ™ -- --2,300 patients on LUMRYZ as of September 30, including 700 patients that initiated therapy in the quarter -- -- Received FDA approval for LUMRYZ for the treatment of cataplexy or EDS in patients 7 years and older with narcolepsy, granted ODE through October 16, 2031 -- -- LUMRYZ approval upheld by court in suit brought by Jazz reg ...

Core Viewpoint - The U.S. District Court for the District of Columbia ruled in favor of the FDA regarding the approval of LUMRYZ, affirming its clinical superiority over Jazz Pharmaceuticals' products for treating narcolepsy [1][2][3] Group 1: Company Overview - Avadel Pharmaceuticals plc is a biopharmaceutical company focused on transforming medicines to improve patient lives [7] - LUMRYZ is the first and only once-at-bedtime oxybate treatment approved for cataplexy or excessive daytime sleepiness in adults and pediatric patients with narcolepsy [4][7] Group 2: FDA Approval and Legal Context - The FDA granted final approval and Orphan Drug Exclusivity to LUMRYZ in May 2023, which was challenged by Jazz Pharmaceuticals [2][6] - The court ruling upheld the FDA's determination that LUMRYZ is clinically superior, allowing it to remain available to the narcolepsy community [1][3] Group 3: Clinical Evidence - LUMRYZ's approval was supported by the REST-ON trial, which showed significant improvements in excessive daytime sleepiness, overall patient functioning, and cataplexy attacks compared to placebo [5][6] - The FDA found that LUMRYZ's once-nightly dosing regimen significantly contributes to patient care by minimizing sleep disruption [6]

Core Viewpoint - Avadel Pharmaceuticals has received FDA approval for the label expansion of Lumryz, allowing its use in pediatric patients aged seven years and older with narcolepsy, which is expected to enhance sales and market presence [1][2]. Group 1: Drug Approval and Market Impact - The FDA approved Lumryz for treating cataplexy or excessive daytime sleepiness in narcolepsy patients aged seven and older, expanding its previous approval for adults [1][2]. - Following the announcement, Avadel's shares increased by 5.1%, although the stock has seen a year-to-date decline of 1.4%, compared to a 0.7% decline in the industry [1]. - Lumryz is a once-at-bedtime formulation of extended-release sodium oxybate, first approved for adults on May 1, 2023, and now includes pediatric patients, with orphan drug exclusivity granted until October 16, 2031 [2]. Group 2: Sales Performance and Future Studies - In Q2 2024, Avadel reported $41.5 million in net product revenues from Lumryz, with over 1,900 patients using the drug as of June 30, up from 1,400 patients in March [4]. - Pediatric patients currently make up about 5% of all oxybate-treated narcolepsy patients, indicating potential for increased sales following the label expansion [4]. - A phase III study is underway to evaluate Lumryz's efficacy in idiopathic hypersomnia, with an expected enrollment of approximately 150 adults [4]. Group 3: Competitive Landscape - Avadel holds a Zacks Rank 3 (Hold), while competitors like Catalyst Pharmaceuticals and ANI Pharmaceuticals have higher rankings, indicating a competitive market environment [5]. - Catalyst Pharmaceuticals has seen a significant increase in EPS estimates, with shares rising 25.9% year-to-date, while ANI Pharmaceuticals has also experienced upward revisions in earnings estimates and a 9% increase in share price [5][6].

-- LUMRYZ is the only FDA-approved once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy— -- Granted Orphan Drug Exclusivity in pediatric narcolepsy patients 7 years and older through October 16, 2031 -- DUBLIN, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that the U.S. Food and Drug Administrati ...