UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ——————— FORM 10-Q ——————— ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37977 For the quarterly period ended: March 31, 2025 OR AVADEL PHARMACEUTICALS PLC (Exact name of registrant as specified in its charter) ——————— N/A (Address of Principal ...

Financial Data and Key Metrics Changes - The company reported net revenue of $52.5 million for Q1 2025, representing over 90% growth compared to Q1 2024, which had net revenue of $27.2 million [9][17] - Gross profit for Q1 2025 was $46.9 million, up from $25.7 million in the prior year [17] - The company raised its full-year revenue guidance to $255 million to $265 million from a previous range of $240 million to $260 million [17][9] - Cash operating expenses for Q1 2025 were reported at $44.9 million, a decrease of 3% year-over-year [20] Business Line Data and Key Metrics Changes - The company ended Q1 2025 with 2,800 patients on LUMRIZE, reflecting 100% growth year-over-year [8] - There was a 50% increase in net new patients during Q1 compared to Q4 2024, with an addition of 300 patients [8] - The sales force was increased by 15% effective January 1, 2025, contributing to positive patient demand growth across all segments [9][10] Market Data and Key Metrics Changes - The company is pursuing additional indications for LUMRIZE beyond narcolepsy, with a favorable court ruling allowing for further development [6][7] - The phase three REVITALIZE trial for idiopathic hypersomnia is on track, with expectations to complete enrollment by the end of 2025 [13] Company Strategy and Development Direction - The company aims to achieve $1 billion in LUMRIZE narcolepsy revenue while expanding its impact to other patient populations [16] - There is a focus on lifecycle management initiatives to maximize the potential of LUMRIZE beyond narcolepsy [23] - The company is also developing a once-nightly lower sodium oxybate program to serve patients with hypersomnia-related disorders [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth plan and the positive momentum seen in Q1 2025, expecting to build on this throughout the year [6][8] - The company remains focused on sustaining momentum and achieving sustainable positive cash flow [23] - Management highlighted the importance of their robust intellectual property portfolio, which protects LUMRIZE until 2042 [24] Other Important Information - The company ended Q1 2025 with $66.5 million in cash, cash equivalents, and marketable securities [21] - The company is actively pursuing legal actions against Jazz Pharmaceuticals to protect its business and intellectual property [15] Q&A Session Summary Question: Revised 2025 guidance and growth assumptions - Management confirmed that the first half of 2025 is expected to show sequential growth quarter-over-quarter, with a focus on improving key metrics [29][30] Question: Appeal case ruling implications - Management stated that the ruling was aligned with their base case scenario and provides a clear path to continue executing their plans [34][35] Question: Patient footprint potential for LUMRIZE in IH - Management views the IH opportunity as highly untapped and believes LUMRIZE can successfully source patients from various segments [39] Question: Average selling price and guidance - The average net revenue per patient was reported to be under $80,000 annualized, with expectations for improvement throughout the year [47][48] Question: Patient mix and persistency tactics - Management reported improvements in both switch and new to oxybate patients, with ongoing initiatives to enhance patient engagement and persistency [53][55] Question: Offensive lawsuits and timelines - Management elaborated on their offensive lawsuits against Jazz Pharmaceuticals, asserting their rights regarding intellectual property [83][84]

Financial Data and Key Metrics Changes - The company reported net revenue of $52.5 million for Q1 2025, representing over 90% growth compared to Q1 2024, which had net revenue of $27.2 million [7][18] - Gross profit for Q1 2025 was $46.9 million, up from $25.7 million in the prior year [18] - The company raised its full-year revenue guidance to $255 million to $265 million from a previous range of $240 million to $260 million [17][19] Business Line Data and Key Metrics Changes - The company ended Q1 with 2,800 patients on LUMRIZE, reflecting 100% growth year-over-year [6] - There was a 50% increase in net new patients during Q1 compared to Q4 2024, with an addition of 300 patients [6] - The company expanded its sales force by 15% and doubled the size of its field reimbursement and nursing support teams, contributing to improved patient engagement and persistency [8][9][10] Market Data and Key Metrics Changes - The company is pursuing additional indications for LUMRIZE beyond narcolepsy, particularly idiopathic hypersomnia (IH), with an estimated 42,000 patients diagnosed and only one FDA-approved treatment currently available [11][12] - The company believes LUMRIZE has the potential to unlock significant market opportunities in IH, as prescribers express excitement about the prospect of prescribing it for this condition [11][12] Company Strategy and Development Direction - The company aims to achieve $1 billion in LUMRIZE revenue while expanding its impact to additional patient populations [15] - The company is focused on lifecycle management initiatives to maximize the potential of its once-at-bedtime formulation beyond narcolepsy [23] - The company is actively pursuing legal actions to protect its intellectual property and has a robust portfolio that extends protection until 2042 [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the commercial investments made at the beginning of the year, which are expected to drive sustainable positive cash flow [23] - The company remains optimistic about its growth trajectory, despite potential industry-wide changes related to tariffs and policies impacting biotech [21] - Management highlighted the importance of maintaining financial discipline while scaling operations and expects continued revenue growth and cash flow improvement [19][20] Other Important Information - The company ended Q1 2025 with $66.5 million in cash, cash equivalents, and marketable securities [20] - The company reported a GAAP operating loss of $3 million for Q1, but adjusted operating income was positive at $2 million, marking the third consecutive quarter of positive adjusted operating income [20] Q&A Session Summary Question: Revised 2025 guidance and growth assumptions - Management confirmed that the first half of the year is expected to show sequential growth quarter over quarter, with a focus on improving key metrics [28][29] Question: Nature of the recent court ruling - Management indicated that the ruling was aligned with their base case scenario and provides a clear path to continue executing their plans for LUMRIZE [34][35] Question: Patient metrics and competitive landscape for IH - Management views the IH opportunity as highly untapped and believes LUMRIZE can successfully source patients from various segments, including those not currently treated with oxybate [40][41] Question: Discontinuation rates and updated guidance - Management reported a decrease in discontinuation rates from 14% in Q4 to a lower figure in Q1, contributing to increased confidence in their updated guidance [77][79] Question: Offensive lawsuits and timelines - Management elaborated on their offensive lawsuits against Jazz, asserting their intellectual property rights, and mentioned upcoming administrative steps in the litigation process [81][84]

AVADEL Pharmaceuticals plc (NASDAQ: AVDL) First Quarter 2025 Earnings Slides TRANSFORMING MEDICINES TO TRANSFORM LIVES A BIOPHARMACEUTICAL COMPANY FOCUSED ON 2 Safe Harbor Statements 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, ...

Exhibit 99.1 Avadel Pharmaceuticals Reports First Quarter 2025 Financial Results and Raises Guidance -- Generated $52.5 million in net revenue from sales of LUMRYZ™, a 93% increase over the first quarter of 2024 -- -- 2,800 patients on LUMRYZ as of March 31, 2025, a net increase of 300 patients since December 31, 2024 and a 100% year over year increase over the first quarter of 2024 -- -- Raises 2025 guidance; expects to generate $255 - $265 million in net product revenue and cash flow of $30 - $40 million, ...

-- Generated $52.5 million in net revenue from sales of LUMRYZ™, a 93% increase over the first quarter of 2024 -- -- 2,800 patients on LUMRYZ as of March 31, 2025, a net increase of 300 patients since December 31, 2024 and a 100% year over year increase over the first quarter of 2024 -- -- Raises 2025 guidance; expects to generate $255 - $265 million in net product revenue and cash flow of $30 - $40 million, driven by 3,400 - 3,600 patients on LUMRYZ by year end -- -- Federal Circuit ruled in Avadel's favor ...

- With this ruling, Avadel can seek and be granted FDA approval for LUMRYZ in Idiopathic Hypersomnia - - Federal Circuit decision permits new clinical trials and further development of LUMRYZ™ for the treatment of indications beyond narcolepsy - DUBLIN, Ireland, May 06, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced that the United States Court of Appeals for the Federal Circuit (the “Fede ...

Core Viewpoint - Avadel Pharmaceuticals plc will host a conference call on May 7, 2025, to provide a corporate update and discuss its financial results for Q1 2025 [1]. 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 and older with narcolepsy [3]. Conference Call Details - The conference call will take place at 8:00 a.m. ET on May 7, 2025, and will be accessible via the investor relations section of the company's website [2]. - A replay of the webcast will be available for 90 days following the event [2].

-- Retrospective analysis reveals no significant differences in comorbidities in narcolepsy patients treated vs. not treated with sodium oxybate -- -- One third of patients taking immediate-release, twice-nightly sodium oxybate discontinued treatment, most often due to lack of efficacy; inability to wake up was most common reason for missing second nightly dose -- DUBLIN, April 17, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicin ...

Core Viewpoint - Avadel Pharmaceuticals plc provided an update on its product LUMRYZ and its market performance, addressing patient demand metrics and potential impacts from U.S. tariff policy changes on the biopharmaceutical sector [2][4]. Company Overview - Avadel Pharmaceuticals is focused on transforming medicines to improve patient lives, with a particular emphasis on innovative solutions for medication development [8]. - The company has a market potential of $1 billion in peak annual sales for LUMRYZ, which has shown improvements in patient metrics compared to Q4 2024 [8]. Product Information - LUMRYZ (sodium oxybate) is the first and only once-at-bedtime treatment approved by the FDA for cataplexy or excessive daytime sleepiness in adults and pediatric patients with narcolepsy [5][9]. - The FDA approval was based on the REST-ON™ Phase 3 trial, which demonstrated significant improvements in key endpoints compared to placebo [6]. - LUMRYZ received 7 years of Orphan Drug Exclusivity due to its clinical superiority over existing treatments, offering a once-nightly dosing regimen [7]. Supply Chain and Manufacturing - Avadel has developed a diversified supply chain for LUMRYZ, with all active pharmaceutical ingredients sourced from U.S.-based CDMOs and finished products manufactured in the U.S. and Europe [3][4]. - The company has strengthened its supply chain security, ensuring the capability to manufacture LUMRYZ entirely in the U.S. if necessary [4]. Legal Matters - Avadel has initiated four patent infringement lawsuits against Jazz Pharmaceuticals, alleging that Jazz's Xywav product infringes on five different Avadel patents [8]. Future Outlook - The company expects to generate sustainable positive cash flow in 2025 and is on track to complete enrollment for its Phase 3 trial studying LUMRYZ in Idiopathic Hypersomnia in the second half of 2025 [8].