11月14日， 都柏林，Avadel Pharmaceuticals plc（NASDAQ：AVDL）宣布已收到 H.Lundbeck A/S（"Lundbeck"，灵北制药）的主动收购要约，以每股普通股23.00美元的价格收 购Avadel，其中包括（i）收盘时每股普通股21.00美元的现金，以及（ii）不可转让的或有价值权 （CVR），使持有人有权获得（A）每股普通股1.00美元的潜在额外现金支付，前提是LUMRYZ™ 和valiloxybate在 2027年12月31日之前的日历年 美国的最终用途年净销售额总计至少为4.5亿美 元。以及（b）每股普通股1.00美元，前提是LUMRYZ™和valiloxybate在2030年12月30日之前的 任何日历年在美国的最终用途年净销售额总计至少达到7亿美元（"灵北提案"），该提案总价达 22.5亿美元。灵北提案除其他事项外，还需满足各种成交条件，包括Avadel股东批准和监管部门批 准。Avadel董事会在与其财务和法律顾问协商后，本着诚信 的原则确定，合理预期灵北提案将产 生Avadel与Alkermes （ NASDAQ： ALKS）现有交易协议中定义的"公 ...

Core Insights - A bidding war is emerging in the biotech sector, with Avadel Pharmaceuticals (AVDL) at the center, as Alkermes (ALKS) faces competition from Lundbeck for a potential acquisition [1][2] Group 1: Acquisition Offers - Lundbeck has made an unsolicited bid for Avadel worth up to $2.4 billion, valuing Avadel stock at $23 per share, which includes $21 in cash and $2 tied to contingent value rights (CVRs) [2] - Avadel previously agreed to a $2.1 billion takeover deal from Alkermes, which valued the stock at up to $20 per share, consisting of $18.50 in cash and CVRs worth up to $1.50 per share [2] Group 2: Market Reactions - Following Lundbeck's offer, Avadel's stock surged over 20% to $23.16, while Alkermes' stock fell more than 6% to $29 [4] Group 3: Financial Capacities - Alkermes has $1.1 billion in cash and no debt, with an EBITDA of $380 million, giving it a theoretical deal capacity of $2.7 billion [5] - Lundbeck has $550 million in cash and $1.9 billion in debt, with an EBITDA of $1.3 billion, resulting in a theoretical deal capacity of $3.8 billion [5] Group 4: Contingent Value Rights and Sales Milestones - Lundbeck's deal includes aggressive sales milestones requiring Lumryz and valiloxybate to achieve at least $450 million in U.S. sales annually by 2027 and $700 million before 2030 [7] - Analysts estimate Lumryz will generate $399 million in 2027 and $581 million by 2030, which is below Lundbeck's required sales milestones [7]

Core Viewpoint - Avadel Pharmaceuticals has received an unsolicited acquisition proposal from H. Lundbeck A/S, offering up to $23.00 per ordinary share, which includes cash and contingent value rights, leading the Board to consider it a potential "Company Superior Proposal" compared to its existing agreement with Alkermes [3][5]. Summary by Sections Acquisition Proposal - Lundbeck's proposal includes $21.00 in cash per ordinary share at closing and contingent value rights that could provide an additional $2.00 per share based on sales milestones for LUMRYZ™ and valiloxybate [3]. - The proposal is contingent upon various closing conditions, including shareholder and regulatory approvals [3]. Existing Agreement with Alkermes - Avadel has a definitive transaction agreement with Alkermes, under which shareholders would receive up to $20.00 per ordinary share, consisting of $18.50 in cash and a contingent value right of $1.50 [4]. - The Board's determination regarding Lundbeck's proposal allows for discussions but does not permit Avadel to terminate its agreement with Alkermes [5]. Board's Position - The Board has not yet confirmed that Lundbeck's proposal constitutes a Company Superior Proposal under the existing agreement with Alkermes and has not changed its recommendation in support of the Alkermes acquisition [5][6]. - There is no assurance that discussions with Lundbeck will lead to a definitive agreement [6]. Financial Advisors - Morgan Stanley and Goldman Sachs are serving as financial advisors to Avadel in relation to the acquisition discussions [9][23].

Core Insights - Avadel Pharmaceuticals reported a significant increase in patient enrollment for LUMRYZ, with approximately 3,400 patients treated as of September 30, 2025, representing a 48% increase from the previous year [1] - The company announced a global settlement with Jazz Pharmaceuticals, resolving all litigation and allowing Avadel to commercialize LUMRYZ for additional indications starting March 1, 2028 [9] - Alkermes is set to acquire Avadel for a total transaction value of approximately $2.1 billion, with the deal expected to close in the first quarter of 2026 [2][3] Financial Performance - Avadel generated $77.5 million in net product revenue from LUMRYZ in Q3 2025, marking a 55% increase from $50.0 million in Q3 2024 [10] - Gross profit for Q3 2025 was $81.6 million, or 105% of net product revenue, compared to $43.9 million, or 88% of net product revenue, in the same period of 2024 [11] - Research and development expenses surged to $27.0 million in Q3 2025, up from $3.8 million in Q3 2024, primarily due to upfront license fees related to valiloxybate [12] Corporate Developments - The REVITALYZ™ study, a Phase 3 trial for LUMRYZ, is on track for patient enrollment completion by the end of 2025 [6] - Avadel has strengthened its sleep medicine portfolio by acquiring an exclusive license for valiloxybate from XWPharma, with an upfront payment of $15 million made in Q3 2025 [7] - The company presented new data at World Sleep 2025 supporting LUMRYZ's efficacy in treating narcolepsy across various patient segments [8] Settlement with Jazz Pharmaceuticals - The settlement agreement with Jazz includes the dismissal of lawsuits and upfront cash consideration for Avadel, along with royalty rights for Jazz on LUMRYZ sales from October 1, 2025, to February 18, 2036 [9]

Core Viewpoint - Avadel Pharmaceuticals has entered into an exclusive global license agreement with XWPharma to develop and commercialize valiloxybate, a novel GABAB receptor agonist designed for the treatment of sleep disorders, including narcolepsy and idiopathic hypersomnia, with a unique once-at-bedtime, salt-free, and artificial sweetener-free formulation [1][2][3] Group 1: Licensing Agreement Details - XWPharma grants Avadel an exclusive global license to develop, manufacture, and commercialize valiloxybate, excluding mainland China, Hong Kong, and Macau [3] - XWPharma will receive an upfront payment of $20 million and is eligible for milestone payments up to $30 million related to development milestones [3] - Avadel will pay XWPharma up to $155 million in performance-based tiered sales milestones for achieving annual net sales up to $750 million, and 10% of sales milestones for sales exceeding $750 million and up to $3.5 billion [3] Group 2: Development Timeline - Avadel plans to initiate an initial pharmacokinetic (PK) study in the fourth quarter of 2025, followed by a pivotal PK trial in the second half of 2026 [1][4] - The development program is expected to leverage Avadel's existing infrastructure for efficient clinical and regulatory advancement [4] Group 3: Product Overview - Valiloxybate is designed to provide the therapeutic benefits of oxybate therapy through a once-at-bedtime, salt-free, and artificial sweetener-free formulation, potentially offering a differentiated profile from traditional oxybate therapies [5] - Preliminary clinical data suggest the potential for bioequivalence between valiloxybate and Avadel's existing product, LUMRYZ, which is the first and only once-at-bedtime treatment for narcolepsy [5] Group 4: Market Position and Strategy - The addition of valiloxybate to Avadel's portfolio reinforces its leadership in sleep medicine and reflects the transformative benefits of once-at-bedtime oxybate therapies [2] - The company aims to personalize care for individuals with hypersomnolence disorders, expanding access to innovative therapies for a broader patient population [2][5]