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 ...

– Survey data demonstrate 94% of people with narcolepsy prefer the once-nightly regimen of LUMRYZ over twice-nightly oxybate regimens – – 91% reported being better able to sleep through the night after switching to LUMRYZ – – 93% of those who switched to LUMRYZ would recommend it to family or friends living with narcolepsy – DUBLIN, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced t ...

Avadel Pharmaceuticals plc (NASDAQ:AVDL) Q2 2024 Earnings Conference Call August 8, 2024 8:30 AM ET Company Participants Austin Murtagh - Director, Precision AQ Greg Divis - Chief Executive Officer Richard Kim - Chief Commercial Officer Jennifer Gudeman - Senior Vice President, Medical & Clinical Affairs Tom McHugh - Chief Financial Officer Conference Call Participants Andrew Tsai - Jefferies François Brisebois - Oppenheimer Ami Fadia - Needham & Company David Amsellem - Piper Sandler Marc Goodman - Leerink ...

Avadel. Avadel Pharmaceuticals plc (NASDAQ: AVDL) August 2024 ©2024 Avadel. All rights reserved. Safe Harbor Statements 2 This presentation may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects, or other events. Such forward-looking statements i ...

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: June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period f ...