The Vanguard Group, Inc. (IRSH)Form 8.3 - The Vanguard Group, Inc.: Avadel Pharmaceuticals plc 26-Dec-2025 / 15:08 GMT/BSTAp27   FORM 8.3   IRISH TAKEOVER PANEL   OPENING POSITION DISCLOSURE/DEALING DISCLOSURE UNDER RULE 8.3 OF THE IRISH TAKEOVER PANEL ACT, 1997, TAKEOVER RULES, 2022 BY PERSONS WITH INTERESTS IN RELEVANT SECURITIES REPRESENTING 1% OR MORE   1. KEY INFORMATION             Full name of discloser The Vanguard Group, Inc.           Owner or controller of interests and short positions discl ...

- Data expected in Q2 2026 - DUBLIN, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced the completion of patient enrollment in REVITALYZ, a Phase 3 trial evaluating LUMRYZTM (sodium oxybate) extended-release oral suspension as a potential treatment for idiopathic hypersomnia (IH). REVITALYZ is a double-blind, placebo-controlled, randomized withdrawal, multicenter Phase 3 trial designed to e ...

Core Viewpoint - Alkermes plc has reached an agreement to acquire Avadel Pharmaceuticals plc, with the transaction structured as a scheme of arrangement under Irish law [1][8]. Group 1: Proposed Transaction Details - The acquisition involves Alkermes acquiring the entire issued and to be issued ordinary share capital of Avadel [1]. - The Proposed Transaction will be implemented through a scheme of arrangement under Chapter 1 of Part 9 of the Irish Companies Act 2014 [1][8]. - A joint letter detailing the proposal has been sent to Avadel Equity Award Holders and ESPP Participants [2]. Group 2: Company Profiles - Alkermes is a global biopharmaceutical company focused on developing innovative medicines for neurological disorders, with a portfolio that includes treatments for alcohol and opioid dependence, schizophrenia, and bipolar I disorder [4]. - Avadel Pharmaceuticals specializes in transforming medicines to improve patient outcomes, with its commercial product LUMRYZ™ approved for treating narcolepsy [5][6]. Group 3: Additional Information - The Rule 15 Proposal is available for inspection on both Avadel's and Alkermes' websites [3]. - Avadel filed a definitive proxy statement with the U.S. Securities and Exchange Commission on December 3, 2025, which includes important information regarding the Proposed Transaction [9][11].

Core Viewpoint - Alkermes plc has reached an agreement to acquire Avadel Pharmaceuticals plc, with the transaction structured as a scheme of arrangement under Irish law [1][7]. Group 1: Proposed Transaction Details - The acquisition involves Alkermes acquiring the entire issued and to be issued ordinary share capital of Avadel [1]. - A proxy statement has been mailed to Avadel shareholders, detailing the terms and conditions of the Proposed Transaction [2]. - The Scheme Meeting for Avadel shareholders is scheduled for January 12, 2026, at 10:00 a.m. Irish local time, followed by an extraordinary general meeting at 10:15 a.m. [3]. Group 2: Company Background - Avadel Pharmaceuticals plc is a biopharmaceutical company focused on innovative medication solutions, with its commercial product LUMRYZ™ approved for treating narcolepsy [4].

Core Viewpoint - Alkermes plc has reached an agreement to acquire Avadel Pharmaceuticals plc, with the transaction structured as a scheme of arrangement under Irish law [1][8]. Group 1: Proposed Transaction Details - The acquisition will involve Alkermes acquiring the entire issued and to be issued ordinary share capital of Avadel [1]. - The transaction is to be implemented via a scheme of arrangement under Chapter 1 of Part 9 of the Irish Companies Act 2014 [1]. - The Irish High Court has ordered a scheme meeting for Avadel shareholders to consider and vote on the scheme [2]. Group 2: Meeting Information - The Scheme Meeting is scheduled for January 12, 2026, at 10:00 a.m. Irish local time, followed by an extraordinary general meeting (EGM) at 10:15 a.m. or as soon as possible thereafter [3]. - Both meetings will take place at the offices of Arthur Cox LLP in Dublin, Ireland [3]. Group 3: Shareholder Communication - A proxy statement, which serves as a scheme circular, will be mailed to Avadel shareholders around December 3, 2025, detailing the terms and conditions of the proposed transaction [4]. - The definitive Proxy Statement will include important information regarding the transaction and will be sent to shareholders as of the record date of November 25, 2025 [9]. Group 4: Company Overview - Avadel Pharmaceuticals plc is a biopharmaceutical company focused on innovative medication solutions, with its commercial product LUMRYZ™ approved for treating narcolepsy [5].

Core Insights - Avadel Pharmaceuticals plc (NASDAQ:AVDL) is experiencing a decline in stock performance, dropping 6.67% to $21.40 amid a lack of new catalysts for investors [1][4] - Alkermes PLC has revised its acquisition offer for Avadel, now valuing the company at $2.37 billion with a new offer of $22.50 per share [2][3] - The updated offer from Alkermes includes $21 in cash and a contingent value right of $1.50 per share, contingent upon FDA approval of Lumryz [3] Group 1: Stock Performance - Avadel's stock fell by 6.67% on Wednesday, indicating investor sell-off due to absence of fresh buying catalysts [1][4] - The initial acquisition offer from Alkermes was $20, which has now been increased to $22.50, reflecting a significant upward revision [4] Group 2: Acquisition Details - The revised acquisition offer from Alkermes includes $21 in cash and a contingent value right of $1.50, which is dependent on FDA approval of Lumryz [3] - H. Lundbeck A/S has also made a competing bid for Avadel at $23 per share, which includes $21 in cash and $2 in contingent value rights [4] Group 3: Agreement Terms - The initial agreement between Avadel and Alkermes allows Avadel to engage with other potential buyers, but it cannot terminate the existing agreement with Alkermes [5]

Core Insights - Avadel Pharmaceuticals plc is focused on developing innovative medicines for sleep disorders, particularly narcolepsy, and operates in a competitive landscape with peers like Eyenovia, Aquestive Therapeutics, Clearside Biomedical, and Intra-Cellular Therapies [1] Financial Performance - Avadel's Return on Invested Capital (ROIC) is 0.86%, which is significantly lower than its Weighted Average Cost of Capital (WACC) of 10.91%, indicating inefficiency in capital use [2] - Eyenovia, Inc. has a ROIC of -33.32% and a WACC of 17.12%, resulting in a ROIC to WACC ratio of -1.94 [3] - Aquestive Therapeutics, Inc. shows a ROIC of -69.51% against a WACC of 13.24%, leading to a ROIC to WACC ratio of -5.25 [3] - Clearside Biomedical, Inc. presents a ROIC of -177.13% and a WACC of 18.30%, resulting in a ROIC to WACC ratio of -9.67 [4] - Intra-Cellular Therapies, Inc. has a ROIC of -8.23% and a WACC of 5.90%, with a ROIC to WACC ratio of -1.39, indicating slightly better capital efficiency compared to peers [4] Industry Challenges - The analysis indicates a challenging environment for biopharmaceutical companies, as none are generating sufficient returns to cover their cost of capital, highlighting the need for improved capital efficiency to enhance investor confidence [5]

Core Insights - Alkermes has increased its offer to acquire Avadel Pharmaceuticals to $22.50 per share, valuing the deal at approximately $2.37 billion [1][7][8] - The acquisition battle involves Denmark-based Lundbeck, which previously made an unsolicited offer of $23.00 per share for Avadel [4][6] - Avadel's board has determined that Alkermes' revised offer is superior to Lundbeck's proposal [5][9] Company Developments - Alkermes' initial offer was $20.00 per share, which was later revised to $22.50 per share following Lundbeck's unsolicited bid [3][7] - The new offer from Alkermes includes a cash payment of $21.00 and a contingent value right (CVR) worth up to $1.50, contingent on FDA approval of Lumryz by December 2028 [8][10] - Avadel's lead product, Lumryz, generated sales of $198.1 million in the first nine months of 2025, reflecting a year-over-year increase of nearly 67% [11] Market Context - Year to date, Alkermes shares have decreased by 0.3%, while the industry has seen a growth of 16.5% [1] - The ongoing bidding war between Alkermes and Lundbeck raises questions about potential further increases in Lundbeck's offer [12]

Core Insights - Avadel Pharmaceuticals' board has deemed Lundbeck's unsolicited acquisition offer as a "Company Superior Proposal" compared to the existing agreement with Alkermes [1][8][10] Acquisition Offers - Lundbeck has made an unsolicited offer to acquire Avadel for up to $23.00 per share, valuing the company at approximately $2.4 billion, which represents a 29% premium over Avadel's closing price on October 21, 2025 [2][6] - The previous agreement with Alkermes was for up to $20.00 per share, totaling around $2.1 billion [3][10] Financial Performance - Avadel's shares have increased by 119% year-to-date, significantly outperforming the industry average rise of 6.4% [5] - Lumryz, Avadel's lead product, generated sales of $198.1 million in the first nine months of 2025, marking a year-over-year increase of nearly 67% [9] Product Details - Lumryz is approved as the first and only once-at-bedtime oxybate for treating cataplexy or excessive daytime sleepiness in patients aged seven years and older with narcolepsy [7] Next Steps in Acquisition Process - Following Lundbeck's offer, Avadel has activated a five-business-day window for Alkermes to potentially revise its acquisition proposal [10][11] - If Avadel determines that Lundbeck's offer remains superior after this period, it may terminate the agreement with Alkermes [11][12]

Core Insights - Avadel Pharmaceuticals plc (NASDAQ:AVDL) is recognized as a promising small-cap stock following its recent financial performance and product developments [1][2]. Financial Performance - In Q3 2025, Avadel reported a revenue increase of 54.86% year-over-year, reaching $77.47 million, which exceeded analysts' expectations by $3.89 million [2]. - The company reported a net income of $20,000 for the quarter, a notable improvement from a net loss of $2.6 million in the same quarter the previous year, which translates to a negative EPS of $0.03 [3]. - The revenue growth was primarily driven by strong sales of LUMRYZ, with a 48% increase in patients using the drug, totaling 3,400 patients as of September 30, 2025 [2][3]. Product Information - Avadel Pharmaceuticals specializes in developing extended-release drug formulations, with its flagship product being LUMRYZ, an FDA-approved therapy for excessive daytime sleepiness in narcolepsy patients [4].