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, ...

- 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 ...