Core Insights - Avadel Pharmaceuticals has appointed Sev Melkonian as Vice President of Patient Services, Distribution, and Reimbursement, bringing over 20 years of healthcare operations experience [1][2] - The company emphasizes the importance of patient support and experience with its product LUMRYZ, which is the first and only once-at-bedtime oxybate approved for narcolepsy treatment [2][3] - Mr. Melkonian's previous experience includes leadership roles at Takeda Pharmaceuticals and CVS Health, which will aid in accelerating LUMRYZ's adoption [2][3] Company Overview - Avadel Pharmaceuticals is focused on transforming medicines to improve patient lives, with a commitment to innovative solutions in medication development [3] - LUMRYZ is specifically approved for treating cataplexy or excessive daytime sleepiness (EDS) in patients aged 7 years and older with narcolepsy [3]

Group 1 - The biotech sector has seen significant discussions around buy-write or covered call opportunities, indicating a focus on trading strategies within this industry [1] - High beta stocks experienced a notable sell-off, with the Russell 2000 index declining approximately 3.5% as the yield on the 10-Year Treasury surpassed 4.75% [2] - A model portfolio featuring 12-20 high upside biotech stocks is being offered by an investment group, along with live chat discussions and weekly research updates [2] Group 2 - The investment group provides market commentary and portfolio updates every weekend, suggesting a proactive approach to market changes [2]

Growth Stock Forum Overview - The Growth Stock Forum focuses on identifying attractive risk/reward opportunities in growth stocks, particularly in the biotech sector [1] - The forum provides a model portfolio of 15-20 stocks that are updated regularly, along with a top picks list of up to 10 stocks expected to perform well in the current year [2] - Members have access to trading ideas targeting both short-term and medium-term moves, as well as community dialogue and Q&A [2] Avadel Pharmaceuticals Performance - Avadel Pharmaceuticals (NASDAQ: AVDL) shares hit new 52-week lows following the release of preliminary Q4 numbers and 2025 guidance [2] - The 2025 guidance was significantly below expectations due to changes in the patient mix [2] Analyst and Platform Disclosures - The analyst has no stock, option, or derivative positions in any mentioned companies and no plans to initiate such positions within the next 72 hours [3] - The article reflects the analyst's personal opinions and is not influenced by compensation or business relationships with mentioned companies [3] - Seeking Alpha emphasizes that past performance does not guarantee future results and does not provide personalized investment advice [4] - The platform's analysts include both professional and individual investors who may not be licensed or certified by any regulatory body [4]

Revenue and Financial Performance - LUMRYZ net revenue for Q4 2024 estimated at $50.0 million, a 150% increase compared to $19.5 million in Q4 2023[1] - Full-year 2024 net product revenue of approximately $169.0 million, up from $28.0 million in 2023[7] - 2025 net product revenue guidance for LUMRYZ is $240–$260 million, representing 50% year-over-year growth at the midpoint[1] - Cash, cash equivalents, and marketable securities totaled $73.0 million as of December 31, 2024[7] Patient Metrics and Therapy Adoption - 2,500 patients on LUMRYZ as of December 31, 2024, including 600 new patients initiating therapy in Q4[1] - 74% of patients on LUMRYZ therapy were reimbursed as of December 31, 2024[12] - 2025 guidance includes 2,800–3,000 new patient initiations and 3,300–3,500 total patients on therapy by December 31, 2025[12] Sales and Market Expansion - Expanded field sales team by nearly 15% to target under-penetrated prescribers[12] Research and Development - Phase 3 REVITALYZ study for idiopathic hypersomnia expected to complete in H2 2025[12] - Preclinical development ongoing for a low-/no-sodium oxybate formulation bioequivalent to LUMRYZ[12]

Core Insights - Avadel Pharmaceuticals reported approximately $50.0 million in net revenue from LUMRYZ sales for Q4 2024, representing a greater than 150% increase compared to $19.5 million in Q4 2023 [1][5] - The company anticipates LUMRYZ net product revenue to be between $240 million and $260 million in 2025, indicating a 50% year-over-year growth at the midpoint [1][10] - As of December 31, 2024, there were 2,500 patients on LUMRYZ, a more than 275% increase from 900 patients on the same date in 2023 [1][5] Financial Highlights - Full year net product revenue for 2024 is approximately $169.0 million, up from $28.0 million in 2023 [5] - The company ended Q4 2024 with approximately $73.0 million in cash, cash equivalents, and marketable securities [5] - The fourth quarter revenue was impacted by an estimated $6.0 million due to approximately 1.5 fewer weeks of inventory in the channel compared to the previous quarter [5] Patient Adoption and Market Strategy - In Q4 2024, 600 patients initiated therapy with LUMRYZ, contributing to consistent demand across three patient segments: 38% switched from first-generation oxybates, 34% were new to oxybate, and 28% had previously tried and discontinued oxybates [1][5] - Approximately 74% of patients on therapy were reimbursed as of December 31, 2024 [5] - The company has expanded its field sales team by nearly 15% and doubled its field reimbursement team to enhance physician reach and patient fulfillment [5][10] Future Guidance - The company projects a net product revenue range of $240 million to $260 million for 2025, with cash flow expected between $20 million and $40 million [10] - The anticipated number of patients initiating therapy in 2025 is between 2,800 and 3,000, with total patients on therapy expected to reach between 3,300 and 3,500 by December 31, 2025 [10] - Ongoing patient enrollment in the REVITALYZ pivotal study, a Phase 3 trial for idiopathic hypersomnia, is expected to complete in the second half of 2025 [10]

DUBLIN, Jan. 06, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on transforming medicines to transform lives, today announced that the Compensation Committee of Avadel’s Board of Directors approved the grant of non-statutory options to twelve (12) new employees to purchase an aggregate of 131,700 ordinary shares under Avadel’s 2021 Inducement Plan. The awards were granted as an inducement material to the employee’s acceptance of employment with Avadel in accordance wit ...

Company Update - Avadel Pharmaceuticals plc will host a conference call and live webcast on January 8, 2025, at 4:30 p.m. ET to provide a corporate update and discuss preliminary unaudited financial results for Q4 and the full year ended December 31, 2024 [1] - A live audio webcast of the call can be accessed through the investor relations section of the company's website, and a replay will be available for 90 days following the event [2] 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 years and older with narcolepsy [3]

Company Overview - Avadel Pharmaceuticals plc is a biopharmaceutical company focused on transforming medicines to improve patients' lives [3] - The company has developed LUMRYZTM, the first and only once-at-bedtime oxybate approved by the U.S. FDA for treating cataplexy or excessive daytime sleepiness in patients aged 7 years and older with narcolepsy [3] Upcoming Events - Members of Avadel's management will participate in a fireside chat at the Jefferies London Healthcare Conference on November 20, 2024, at 7:30 a.m. GMT / 2:30 a.m. ET [1] - A live webcast of the fireside chat will be available on Avadel's Investor Relations website for 90 days following the conference [2]

Financial Data and Key Metrics Changes - For Q3 2024, the company reported net revenue of $50 million and gross profit of $43.9 million, with an estimated inventory level consistent with the previous quarter [33][34] - The operating loss was reported at $327,000 on a GAAP basis, while adjusted EBITDA was positive at $6.1 million [39][40] - Cash, cash equivalents, and marketable securities totaled approximately $66 million as of September 30, down from $71 million at the end of June [38] Business Line Data and Key Metrics Changes - The LUMRYZ launch saw 2,300 active patients on therapy as of September 30, with 700 new patients initiating therapy in Q3, contributing to the $50 million in net revenue [9][22] - The fastest-growing segment of new patients is those new-to-oxybate, indicating a shift in market dynamics [11][22] - The company is making investments to improve patient persistency, including doubling the number of nurse care navigators and increasing patient engagement efforts [26][70] Market Data and Key Metrics Changes - The company reported strong demand for LUMRYZ, with a notable increase in new-to-oxybate prescribers, now totaling around 150 [27][79] - The overall narcolepsy market is expanding, with indications that LUMRYZ is adding new patients who were previously untreated with oxybate [81] Company Strategy and Development Direction - The company is focused on executing the near-term value drivers, including the continued launch of LUMRYZ and lifecycle management efforts [21] - The recent FDA approval for LUMRYZ in pediatric patients and the initiation of the Phase 3 IH trial are key strategic developments [20][17] - The company aims to maximize LUMRYZ's potential as the preferred oxybate treatment among narcolepsy patients and providers [32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued strong demand for LUMRYZ despite potential seasonality and higher gross-to-net deductions impacting Q4 [45][54] - The company is optimistic about its growth trajectory, particularly with the expansion into the pediatric market and the ongoing legal matters being resolved favorably [19][56] Other Important Information - The company is in the process of addressing legal matters, including ongoing patent trials and antitrust actions against Jazz, which are expected to progress in the coming months [57][59] - The company has received favorable court rulings affirming the clinical superiority of LUMRYZ, which is crucial for its market position [19][60] Q&A Session Summary Question: Can you talk about the patient trends you're seeing so far, including the month of October and the parts of November? - Management noted strong demand for LUMRYZ continues, with a shorter quarter affecting selling days but overall interest remains high [46] Question: Can you help us understand the role of AGs and how you're expanding your sales force? - The company has achieved 85% commercial coverage, making AGs rarely a step for LUMRYZ, and plans to increase the sales force by over 10% to reach moderate and low oxybate prescribers [49][51] Question: Can you provide an update on revenue expectations and litigation? - Management is pleased with progress and expects continued patient demand, while legal matters include ongoing patent trials and an antitrust action against Jazz [54][56] Question: Can you discuss the reasons for higher discontinuation rates among new patients? - Higher discontinuation rates are attributed to new patients not knowing what to expect, necessitating more frequent support and expectation management [64][68] Question: What is the current mix of NT1 and NT2 patients for LUMRYZ? - The prevalence is approximately 30% NT1 and 70% NT2, with LUMRYZ usage consistent with these proportions [83]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ——————— Title of each class Trading Symbol(s) Name of each exchange on which registered Ordinary Shares, nominal value $0.01 per share AVDL The Nasdaq Global Market FORM 10-Q ——————— ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition per ...