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 ...

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].

About Avadel Pharmaceuticals plc DUBLIN, April 01, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that members of management will participate in a fireside chat at the 24 Annual Needham Healthcare Conference on Tuesday, April 8 at 1:30 p.m. ET. A live webcast of the fireside chat, as well as an archived recording, will be available on Avadel's Investor Relations website, investors.avadel.co ...

DUBLIN, March 25, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced the publication of six manuscripts covering clinical management, shared decision-making and goal setting for people with narcolepsy and their clinicians in a CNS Drugs supplement titled "A New Dawn in the Management of Narcolepsy". "I am delighted to serve as guest editor for the recently published CNS Drugs supplement, focused ...

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]

AVADEL Pharmaceuticals plc (NASDAQ: AVDL) Fourth Quarter and Full Year 2024 Earnings 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 perfo ...

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 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 reported 3,450 total net patients added to therapy since LUMRYZ's launch 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 seen promising momentum in patient demand-based metrics, which are currently tracking at or above internal expectations [11][12] - The commercial coverage for LUMRYZ is greater than 90%, with improvements in Medicare coverage this year [75][76] 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][32] - Investments are being made to enhance customer engagement and support services, including expanding the sales team and field support team [15][16] - The company is also focused on ongoing clinical trials, including the Phase III REVITALYZ trial for LUMRYZ in idiopathic hypersomnia [18][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the refined commercial strategy and recent investments to accelerate the launch of LUMRYZ [11][32] - The company expects to see improvements in revenue as early trends in Q1 are favorable and align with internal expectations [29][30] - Management remains optimistic about LUMRYZ's prospects in 2025 and beyond, supported by a robust intellectual property portfolio [32][33] Other Important Information - The company is involved in ongoing litigation, including an antitrust case against Jazz and patent infringement suits to protect its innovations [20][21] - The company is also working on a once-nightly no or low sodium formulation to expand its competitive position in the market [20] Q&A Session Summary Question: Evolution of sales reps and DTC thoughts - The company has increased its sales team by about 15%, now totaling 53, and has doubled the size of its field support and nurse support teams [36][37] Question: Differences between field support and nurse roles - Field support roles focus on patient pull-through from prescription to therapy, while nurse support engages directly with patients [40][42] Question: Q1 patient trends and gross-to-net inventory - Early trends in Q1 are favorable, with expectations for revenue impact in Q2, and inventory levels have remained consistent [52][56] Question: Guidance range assumptions - The most important metrics for guidance are net patients on therapy and demand, with early signs of stabilizing trends in switch patients [60][64] Question: Coverage and switching patients - The company has over 90% commercial coverage, and switching patients have not faced significant hurdles in the reimbursement process [75][77] Question: Long-term implications of orexins - The company believes there will continue to be a role for oxybates, and efforts are being made to ensure LUMRYZ remains the preferred choice [96][98] Question: Geographic regions and cardiovascular comorbidities - There is no specific geographic disposition regarding cardiovascular comorbidities in narcolepsy patients, but once-nightly dosing is highly valued [105][107] Question: Converting one-off prescribers to regular prescribers - Over 200 physicians who have never prescribed oxybate before have now prescribed LUMRYZ, indicating a positive trend in market expansion [112][113] Question: Pediatric indication launch - The company is focused on pediatric prescribers and has seen positive feedback from families benefiting from LUMRYZ [131][132]