Financial Performance - Avadel Pharmaceuticals generated $68.1 million in net revenue in Q2 2025, a 64% year-over-year increase[13] - The company raised FY25 revenue guidance to $265 - $275 million[13] - Avadel achieved cash-flow positive status in Q2 2025[13] - Cash, cash equivalents, and marketable securities totaled $81.5 million as of June 30, 2025[13] - GAAP Operating Income for Q2 2025 was $8.9 million, compared to a loss of $12.7 million in Q2 2024[22] - Non-GAAP Operating Income for Q2 2025 was $15.0 million, compared to a loss of $1.2 million in Q2 2024[24] LUMRYZ and Pipeline Development - Approximately 3,100 patients are currently on LUMRYZ therapy, a 63% increase compared to June 30, 2024[9, 13] - The REVITALYZ Phase 3 trial of LUMRYZ in Idiopathic Hypersomnia (IH) is on track to complete enrollment during 4Q25, with data expected in 1H26[13] - LUMRYZ received Orphan Drug Designation for Idiopathic Hypersomnia (IH)[13] - Approximately 11% of the 42,000 US patients diagnosed with IH are treated with the only FDA approved oxybate treatment[18]

Core Viewpoint - The U.S. Court of Appeals affirmed the FDA's approval of LUMRYZ, validating its innovative formulation and clinical superiority for treating narcolepsy [1][2][3] Company Overview - Avadel Pharmaceuticals plc is focused on transforming medicines to improve patient lives, with LUMRYZ being its commercial product approved for narcolepsy treatment [20] - The company aims to expand the patient base for LUMRYZ beyond the current thousands treated [2] Product Details - LUMRYZ is the first and only once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness in patients aged 7 and older with narcolepsy, approved by the FDA on May 1, 2023 [4][20] - The FDA granted LUMRYZ 7 years of Orphan Drug Exclusivity due to its clinical superiority over existing treatments [6] Clinical Evidence - The approval of LUMRYZ was supported by the REST-ON™ Phase 3 trial, which showed significant improvements in excessive daytime sleepiness, overall patient functioning, and cataplexy attacks compared to placebo [5] - The once-at-bedtime dosing regimen of LUMRYZ is clinically superior to first-generation immediate-release oxybates, providing a major contribution to patient care [2][6]

Core Insights - Avadel Pharmaceuticals has appointed Susan Rodriguez as Chief Operating Officer to lead the company's commercial strategy and operations, particularly in relation to the launch of LUMRYZ [1][2][17] - Rodriguez brings over 30 years of experience in the life sciences industry, having held leadership roles in various biopharmaceutical companies, which positions her well to support Avadel's growth and market expansion [2][17] Company Developments - LUMRYZ, an extended-release sodium oxybate medication, was approved by the FDA on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness in adults with narcolepsy [3][5][17] - The FDA also approved LUMRYZ for pediatric patients aged 7 years and older on October 16, 2024, further expanding its market potential [3][5] Clinical and Regulatory Highlights - The approval of LUMRYZ was supported by the REST-ON™ Phase 3 trial, which demonstrated significant improvements in excessive daytime sleepiness, overall patient functioning, and cataplexy attacks compared to placebo [4][5] - LUMRYZ has been granted 7 years of Orphan Drug Exclusivity due to its clinical superiority over existing treatments, providing a once-nightly dosing regimen that enhances patient care [5][6] Market Position and Strategy - The company aims to scale operations to meet increasing patient demand for LUMRYZ, particularly in the narcolepsy community, and is exploring potential label expansion to include idiopathic hypersomnia [2][17] - Rodriguez's expertise in launching innovative therapies in rare diseases is expected to be instrumental in accelerating the growth of LUMRYZ and maximizing its market impact [2][17]

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]

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]

Financial Data and Key Metrics Changes - For Q4 2024, the company reported net revenue of $50.4 million and gross profit of $45.6 million, with a GAAP operating loss of $3.3 million [23][26] - The company achieved cash flow positive status for the first time since the launch of LUMRYZ, resulting in an increase in cash of approximately $8 million, ending 2024 with $74 million in cash, cash equivalents, and marketable securities [25][26] - Revenue guidance for 2025 is projected to be in the range of $240 million to $260 million, representing a nearly 50% increase over 2024 [27][29] Business Line Data and Key Metrics Changes - LUMRYZ has added over 2,500 net patients since its launch, which is approximately three times that of the nearest competitor [8][10] - Nearly 75% of the total 3,450 net patients added to either LUMRYZ or the twice-nightly mixed salts product are on LUMRYZ as of December 31 [9][10] - The company is seeing broad adoption across all three patient segments: switch patients, oxybate naive, and those who previously discontinued an oxybate [13][14] Market Data and Key Metrics Changes - The company has a commercial coverage of over 90% for its product, which is comparable to competitors [75] - The company is focusing on expanding its prescriber base, with over 200 physicians who have never prescribed an oxybate now prescribing LUMRYZ [112] Company Strategy and Development Direction - The company aims to secure its leadership in the sleep space and maximize the potential of LUMRYZ, which has a market opportunity of $1 billion [10][12] - The refined commercial strategy includes investments to accelerate the launch and enhance patient experience, with a focus on expanding the oxybate market [14][15] - The company is also working on a once-nightly no or low sodium formulation to expand its competitive position in the market [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in LUMRYZ's prospects for 2025 and beyond, citing positive early trends in patient demand metrics [11][32] - The company is optimistic about achieving sustainable operating breakeven and generating positive cash flow in 2025 [27][29] - Management noted that early trends in Q1 are tracking in line with internal expectations, indicating significant year-over-year revenue growth [29][30] Other Important Information - The company is progressing in its Phase III REVITALYZ trial evaluating LUMRYZ in idiopathic hypersomnia, with topline data expected in early 2026 [18][19] - The company is actively involved in ongoing litigation to protect its intellectual property and market position [20] Q&A Session Summary Question: Evolution of sales reps and DTC efforts - The company increased its sales team by 15% to 53 members and doubled the size of its field support and nurse support teams [36][37] Question: Differences between field support and nurse support - Field support focuses on patient pull-through and engagement with physician offices post-prescription, while nurse support directly engages with patients [40][41] Question: Q1 patient trends and gross-to-net inventory - Management noted favorable trends in patient metrics and consistent inventory levels in the channel [52][56] Question: Guidance range drivers - Key drivers include net patients on therapy and demand mix, with early signs of stabilizing trends in switch patients [62][65] Question: Coverage and switching patients - The company has over 90% commercial coverage and has seen minimal hurdles in switching patients to LUMRYZ [75][78] Question: Long-term implications of orexins - Management believes there will still be a role for oxybates, including LUMRYZ, as a nighttime agent despite the excitement around orexin therapies [96][97] Question: Geographic regions and cardiovascular comorbidities - The company has not identified specific geographic areas with lower cardiovascular comorbidities but emphasizes the importance of once-nightly dosing [105][107] Question: Converting one-off prescribers to regular prescribers - The company has seen over 200 new prescribers and is expanding its reach to similar physicians [112][113] Question: Pediatric indication launch - The company is focusing on pediatric prescribers and has seen positive feedback from families benefiting from LUMRYZ [131][132]