Avadel (AVDL) closed the last trading session at $9.39, gaining 22.3% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $18.80 indicates a 100.2% upside potential.The average comprises 10 short-term price targets ranging from a low of $12 to a high of $27, with a standard deviation of $4.59. While the lowest estimate indicates an increase of 27.8% from the current price level, the mo ...

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]

Financial Performance & Guidance - Avadel Pharmaceuticals generated $52.5 million in net revenue in Q1 2025, a 93% increase year-over-year[11] - The company raised FY25 revenue guidance to $255 - $265 million, previously $240 - $260 million[12] - Q2 2025 revenue guidance is $60 - $63 million[12] - FY25 cash flow guidance was raised to $30 - $40 million, previously $20 - $40 million[12] - The company had $66.5 million of cash, cash equivalents, and marketable securities as of March 31, 2025[12] LUMRYZ Commercialization - Approximately 2,800 patients are currently on LUMRYZ therapy, with a net increase of 300 patients in Q1 2025[7, 11] - The company raised guidance for patients on therapy to 3,400 – 3,600 by the end of 2025, previously 3,300 – 3,500[11] - Reimbursed patients on therapy as of March 31, 2025, are over 2,000[19] - The company estimates LUMRYZ peak sales opportunity is greater than $1 billion for narcolepsy[16] Clinical Development - Enrollment remains robust in the Phase 3 REVITALYZ trial for Idiopathic Hypersomnia (IH), with completion expected in Q4 2025[11, 20] - The REVITALYZ trial targets approximately 150 patients for a 14-week period[20] - Approximately 10% of the 42,000 diagnosed IH patients in the US are treated with the only FDA-approved oxybate treatment[20]

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, ...

Core Insights - Avadel Pharmaceuticals reported a strong financial performance for the first quarter of 2025, with net revenue from LUMRYZ sales reaching $52.5 million, a 93% increase compared to the same period in 2024 [1][5][9] - The company has raised its 2025 guidance, expecting net product revenue between $255 million and $265 million, driven by an anticipated increase in patients using LUMRYZ [2][5] - A favorable ruling from the Federal Circuit allows Avadel to pursue FDA approval for LUMRYZ in idiopathic hypersomnia, expanding its market potential [1][5][2] Financial Performance - Net product revenue for the first quarter of 2025 was $52.5 million, up from $27.2 million in the first quarter of 2024, marking a 93% growth [5][9] - Total operating expenses decreased by 3% to $49.9 million in Q1 2025 from $51.7 million in Q1 2024 [9][10] - The net loss for the quarter was $4.9 million, or $0.05 per diluted share, significantly improved from a net loss of $27.3 million, or $0.30 per diluted share, in the same quarter of 2024 [11][36] Patient Metrics - As of March 31, 2025, there were 2,800 patients on LUMRYZ, reflecting a net increase of 300 patients since December 31, 2024, and a 100% year-over-year increase [1][5] - The company expects to have between 3,400 and 3,600 patients on LUMRYZ by the end of 2025 [2][5] Regulatory and Clinical Developments - The Federal Circuit's ruling allows Avadel to initiate new clinical trials and pursue FDA approval for LUMRYZ's use in idiopathic hypersomnia [1][5][2] - Enrollment in the pivotal Phase 3 REVITALYZ study for LUMRYZ in idiopathic hypersomnia is on track to complete by the end of 2025 [7][2] Corporate Strategy - Avadel has made investments to expand its customer-facing teams, enhancing support and engagement with patients and providers [2][5] - The company initiated four patent infringement lawsuits against Jazz Pharmaceuticals, alleging infringement related to Jazz's Xywav product [6]

Core Viewpoint - The Federal Circuit's ruling allows Avadel Pharmaceuticals to pursue FDA approval for LUMRYZ in Idiopathic Hypersomnia and to conduct new clinical trials for indications beyond narcolepsy [1][2][3] Group 1: Legal and Regulatory Developments - The Federal Circuit vacated the injunction that prevented Avadel from applying for FDA approval of LUMRYZ for indications beyond narcolepsy, criticizing the Delaware Court's analysis as "speculative and tenuous" [2] - The ruling also permits Avadel to offer open-label extensions to trial participants and initiate new clinical trials with LUMRYZ for potential indications beyond narcolepsy [2] Group 2: Clinical Trials and Product Development - Avadel plans to initiate new clinical trials and seek FDA approval for LUMRYZ in Idiopathic Hypersomnia, with the REVITALYZ trial expected to complete patient enrollment by the end of 2025 [3] - The REVITALYZ trial is a Phase 3 study designed to evaluate the efficacy and safety of LUMRYZ in approximately 150 adults diagnosed with Idiopathic Hypersomnia [3] Group 3: Product Information - LUMRYZ is an extended-release sodium oxybate medication approved by the FDA as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness in adults with narcolepsy [4][6] - The FDA granted LUMRYZ 7 years of Orphan Drug Exclusivity due to its clinical superiority over existing treatments, providing a once-nightly dosing regimen that avoids nocturnal arousal [6]

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 ...