- 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 ...

DUBLIN, Ireland, April 30, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that it will host a conference call and live webcast at 8:00 a.m. ET on Wednesday, May 7, 2025, to provide a corporate update and discuss the Company's financial results for the first quarter ended March 31, 2025. A live audio webcast of the call can be accessed by visiting the investor relations section of the Compan ...

-- 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 ...

Avadel Pharmaceuticals plc (NASDAQ:AVDL) Q4 2024 Earnings Conference Call March 3, 2025 8:30 AM ET Company Participants Austin Murtagh - Precision AQ Gregory Divis - Chief Executive Officer Thomas McHugh - Chief Financial Officer Conference Call Participants François Brisebois - Oppenheimer Poorna Kannan - Needham & Company Oren Livnat - H.C. Wainwright & Co. David Amsellem - Piper Sandler & Co. Madhumita Yennawar - Leerink Partners Myriam Belghiti - LifeSci Capital David Hoang - Deutsche Bank AG Brandon Fo ...

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]

Regulatory Approvals and Compliance - LUMRYZ received FDA approval in May 2023 for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy, with a subsequent approval for pediatric use in October 2024[111]. - The company faces significant regulatory restrictions on the distribution and sale of LUMRYZ, including the requirement to maintain a Risk Evaluation and Mitigation Strategy (REMS) due to the drug's association with serious side effects[192]. - Compliance with ongoing regulatory requirements is critical, as failure to do so could result in penalties or withdrawal of LUMRYZ from the market[124]. - Regulatory approval in one jurisdiction does not guarantee approval in others, which may delay or prevent the introduction of LUMRYZ in certain countries[163]. - The FDA's review and approval process for new products can be affected by various factors, including government budget and funding levels, which may impact the company's ability to launch new products[198]. - The company is subject to extensive regulation by the FDA and other authorities, and failure to comply with these regulations could significantly impact its ability to produce and market products[270][272]. Financial Performance and Profitability - The company incurred a net loss of $48,832 for the year ended December 31, 2024, and may incur a net loss in 2025, indicating potential challenges in achieving profitability[184]. - The company’s ability to achieve profitability is uncertain and may fluctuate significantly from quarter to quarter, impacting stock price and investor expectations[185]. - The company reported a net loss of $48,832 in 2024 and cash used in operating activities of $46,907, with total cash, cash equivalents, and marketable securities amounting to $73,777 as of December 31, 2024[191]. - The company may require additional financing to fund the commercialization of LUMRYZ and the development of new products, which could result in dilution of existing shareholders[186]. - The company anticipates that pricing pressures will continue due to managed healthcare trends and cost containment initiatives[155]. - The effective tax rate of the company could be highly volatile and may adversely affect its operating results[294]. Market Challenges and Competition - Market acceptance of LUMRYZ among patients and healthcare providers is uncertain, which could limit revenue generation[123]. - The company faces challenges in generating sufficient revenues to achieve profitability, including potential limitations in reimbursement for LUMRYZ[112]. - Competition in the pharmaceutical and biotechnology industry is intense, with competitors having greater financial and technological resources, which may hinder the company's ability to gain market share[132]. - The introduction of generic versions of LUMRYZ, such as those launched by Hikma Pharmaceuticals and Amneal Pharmaceuticals, could adversely affect sales[129]. - The potential target population for LUMRYZ may be smaller or more difficult to identify than anticipated, affecting revenue potential[120]. - The company may face challenges in expanding LUMRYZ into other populations and obtaining timely approvals for commercialization outside the U.S.[187]. Manufacturing and Supply Chain Risks - The company does not own or operate manufacturing facilities and relies entirely on third-party contract manufacturers, increasing the risk of supply interruptions[216]. - The company relies on a limited number of suppliers for the development and manufacture of LUMRYZ, which poses risks if these suppliers fail to meet regulatory requirements or supply sufficient quantities[213]. - The annual manufacturing and procurement quota for sodium oxybate may not meet the commercial demand for LUMRYZ, potentially delaying or stopping commercial activities[209]. - The company may face significant delays and additional costs if it needs to change contract manufacturers due to performance failures or regulatory issues[219]. - The company expects to continue relying on third parties for clinical trials, which could lead to delays in obtaining regulatory approvals if these parties do not perform adequately[228]. Intellectual Property and Legal Risks - The company’s ability to protect its intellectual property is crucial for competition, as failure to do so may allow competitors to exploit its technologies[236]. - Patent law is evolving, and challenges to the validity of patents could limit the company's ability to protect its products and technologies[237]. - The company may face significant costs and delays due to potential patent infringement claims from third parties[245]. - A 505(b)(2) NDA submission could expose the company to patent infringement lawsuits, delaying product approval and commercialization[249]. - The company may not be able to protect its intellectual property rights globally due to high costs and varying enforcement levels in different jurisdictions, which could allow competitors to use its technologies[258][259]. Employee and Operational Challenges - The company has significantly increased its employee base, which may lead to challenges in managing growth and operational efficiency[226]. - The company is dependent on key personnel for executing its business plan, and the loss of these individuals could impede its strategic objectives[224]. - The company faces competition in seeking collaborations for the commercialization of LUMRYZ, which may affect its ability to realize profits from the product[232]. - The company has significantly increased its sales organization and commercial infrastructure to support the launch of LUMRYZ, leading to ongoing significant expenses[184]. Financial and Tax Considerations - The company has approximately $71,588 million of net operating losses in Ireland that do not have an expiration date[298]. - The company may experience ownership changes that could limit its ability to utilize net operating losses[297]. - Changes in tax law could adversely affect the company's business and financial condition, impacting cash flow and results of operations[295]. - The company incurs significant costs related to compliance as a public company, including legal, accounting, and other expenses, which increase operational costs[303][304]. Insurance and Liability Risks - The company maintains property, business interruption, and casualty insurance, but the coverage limits may be inadequate to cover actual liabilities or damages[277]. - Product liability claims related to current or future products could result in significant compensation payments, and insurance coverage may be inadequate[273][274]. - The company may face claims regarding the wrongful use or disclosure of third-party confidential information, which could lead to costly litigation and loss of intellectual property rights[268][269].