Core Viewpoint - Alkermes plc acknowledges the announcement by Avadel Pharmaceuticals plc regarding a potential acquisition offer from H. Lundbeck A/S for all issued and to be issued ordinary shares of Avadel [1][2]. Group 1: Transaction Agreement Details - The Transaction Agreement stipulates that Avadel cannot terminate the agreement to pursue a superior proposal unless the board determines that doing so is consistent with its fiduciary duties and that the Lundbeck offer qualifies as a superior proposal [3]. - Avadel must notify Alkermes in writing at least five business days prior to taking any action related to the Lundbeck offer and must engage in good faith discussions with Alkermes regarding any amendments to the Transaction Agreement [3]. Group 2: Future Announcements - Alkermes will make further announcements as appropriate regarding the situation and any developments related to the potential acquisition [4].

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].

Summary of Alkermes Conference Call Company Overview - **Company**: Alkermes (NasdaqGS:ALKS) - **Event**: 2025 Conference on November 13, 2025 Key Industry Insights - **Focus Area**: Development of drugs for narcolepsy, specifically targeting narcolepsy type 1 (NT1) and type 2 (NT2) with the Rexin compound [2][8] - **Market Dynamics**: The company is addressing major unmet medical needs in the narcolepsy patient population, which has been historically under-researched [8][9] Core Findings from Recent Data Release - **Study Design**: The recent data release focused on NT2 patients, providing new insights into a previously under-studied population [9] - **Efficacy Signal**: The drug demonstrated a clear efficacy signal, particularly in the Maintenance of Wakefulness Test (MWT) at hour two and hour four, despite variability in patient responses [12][14] - **Tolerability**: Higher doses were well tolerated by NT2 patients, contradicting previous assumptions that higher doses would lead to increased adverse effects [10][17] - **Adverse Events**: Commonly reported adverse events included polyuria, urinary urgency, insomnia, and visual disturbances, but these did not significantly impact overall tolerability [17] Statistical Analysis and Drug Development - **Statistical Significance**: The study employed a phase three statistical plan in a phase two study, which complicated the interpretation of some lower doses [54][56] - **Dose Response**: There was a clear dose response observed in individual patient levels, although averaging across responders and non-responders obscured this [15][17] - **Future Studies**: Plans for phase three studies are underway, with a focus on both NT1 and NT2 populations, utilizing MWT and Epworth Sleepiness Scale (ESS) as primary endpoints [87][88] Competitive Landscape - **Market Position**: Alkermes is positioned as a pioneer in the NT2 space, with no direct competitors currently offering similar treatments [43][44] - **Comparison with Existing Treatments**: Current treatments like Provigil and Xyrem have not focused on pure NT2 cohorts, making Alkermes' data unique [46][50] Commercial Strategy and Financial Health - **Revenue Growth**: The company reported continuous growth driven by demand, with a billion-plus dollar top line generating significant profitability [94] - **Acquisition Strategy**: The acquisition of Avadel is being funded through cash generated from strong business performance, avoiding stock dilution [94] Regulatory Environment - **FDA Engagement**: Alkermes is preparing for a type B meeting with the FDA to discuss phase three study designs and endpoints, with expectations to initiate the program in early Q1 [87][88] - **PDUFA 8 Reauthorization**: The company is optimistic about the reauthorization of user fees that fund drug reviews, which is crucial for the drug development process [97][98] Future Directions - **Research Expansion**: Alkermes is exploring additional indications beyond narcolepsy and hypersomnolence, with plans to advance new rexins into clinical trials by 2026 [90] - **Focus on Cognition and Fatigue**: The company aims to incorporate measures of cognition and fatigue into future studies, addressing patient-reported outcomes that are critical for treatment satisfaction [88][89] This summary encapsulates the key points discussed during the conference call, highlighting Alkermes' strategic focus, recent findings, and future plans in the context of the narcolepsy treatment landscape.

Core Insights - Alkermes plc announced positive topline results from the Vibrance-2 phase 2 study for alixorexton in narcolepsy type 2, showing significant improvements in excessive daytime sleepiness and sleep latency compared to placebo [1][2][4] Group 1: Study Results - Alixorexton met dual primary endpoints, showing statistically significant improvements on the Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS) at week eight [2] - The 14 mg and 18 mg doses of alixorexton achieved statistical significance in mean sleep latency improvements compared to placebo [3] - The 18 mg dose also showed statistically significant improvements in excessive daytime sleepiness on the ESS at week eight [4] Group 2: Safety and Tolerability - Alixorexton was generally well tolerated across all doses during the eight-week treatment period, with most treatment-emergent adverse events (TEAEs) being mild to moderate [4] Group 3: Future Plans - Results from Vibrance-2 and the previous Vibrance-1 study support the initiation of a global phase 3 program for alixorexton in patients with narcolepsy type 1 and type 2, planned to start in Q1 2026 [5] - Detailed results, including exploratory patient-reported outcomes related to cognition and fatigue, will be presented at a future scientific meeting [5] Group 4: Ongoing Studies - The Vibrance-3 phase 2 study evaluating alixorexton in adults with idiopathic hypersomnia is currently enrolling [6]

Alkermes (NasdaqGS:ALKS) Update / Briefing November 12, 2025 08:30 AM ET Speaker2Greetings and welcome to the Alkermes conference call. My name is Rob, and I'll be your operator for today's call. All participants will be placed on mute to prevent background noise. If you should require operator assistance during the call, please press star zero on your telephone keypad. Please note that this conference is being recorded. I'll now turn the call over to Sandra Coombs, Senior Vice President of Investor Relatio ...

Core Insights - Alkermes announced that its experimental drug for narcolepsy successfully met the primary objectives in a mid-stage clinical trial [1] Company Summary - The company is advancing its research in the treatment of narcolepsy, indicating progress in its drug development pipeline [1]

Core Insights - Alkermes plc announced positive topline results from the Vibrance-2 phase 2 study, demonstrating the efficacy of alixorexton in patients with narcolepsy type 2 (NT2) [1][14] - Alixorexton met dual primary endpoints, showing statistically significant improvements in wakefulness and excessive daytime sleepiness compared to placebo [1][6] - The drug was generally well tolerated across all tested doses, with no serious treatment-emergent adverse events reported [1][6] Study Details - The Vibrance-2 study involved 93 patients with NT2, randomized to receive alixorexton (10 mg, 14 mg, or 18 mg) or placebo for eight weeks [3][9] - The primary endpoints included improvements in mean sleep latency on the Maintenance of Wakefulness Test (MWT) and reductions in scores on the Epworth Sleepiness Scale (ESS) [9] - The 14 mg and 18 mg doses of alixorexton achieved statistical significance in improving mean sleep latency, while the 18 mg dose showed significant improvement in excessive daytime sleepiness [6][9] Safety Profile - Alixorexton was well tolerated, with most treatment-emergent adverse events being mild to moderate [6][9] - Common adverse events included pollakiuria, insomnia, urinary urgency, dizziness, and headache [6][9] - Approximately 95% of participants completed the eight-week double-blind portion of the trial and continued into an optional five-week open-label extension [6][9] Future Plans - Alkermes plans to initiate a global phase 3 program for alixorexton in the first quarter of 2026 [7][11] - Detailed results from the Vibrance-2 study, including exploratory outcomes related to cognition and fatigue, will be presented at a future scientific meeting [7][11] - The company is also conducting the Vibrance-3 phase 2 study to evaluate alixorexton in adults with idiopathic hypersomnia [7][11]

Core Insights - Alkermes (ALKS) is currently viewed as a better value opportunity compared to Illumina (ILMN) based on various financial metrics and rankings [1][7] Valuation Metrics - Alkermes has a Zacks Rank of 1 (Strong Buy), indicating a positive earnings outlook, while Illumina has a Zacks Rank of 3 (Hold) [3] - The forward P/E ratio for Alkermes is 16.69, significantly lower than Illumina's forward P/E of 25.86, suggesting that Alkermes may be undervalued [5] - Alkermes has a PEG ratio of 1.36, compared to Illumina's PEG ratio of 2.62, indicating a more favorable valuation relative to expected earnings growth [5] - The P/B ratio for Alkermes is 3.11, while Illumina's P/B ratio is 7.81, further supporting the notion that Alkermes is undervalued [6] - Based on these metrics, Alkermes has earned a Value grade of B, whereas Illumina has a Value grade of C [6] Earnings Outlook - Alkermes is noted for its improving earnings outlook, which enhances its attractiveness as a value investment [7]

Core Insights - Top Wall Street analysts have revised their outlook on several prominent companies, indicating a shift in market sentiment and potential investment opportunities [1] Company Analysis - Analysts are considering buying ALKS stock, suggesting a positive outlook for the company [1]

Group 1: Company Performance - Alkermes (ALKS) has shown a year-to-date performance increase of approximately 8%, outperforming the average return of 1.3% for Medical companies [4] - The Zacks Consensus Estimate for ALKS' full-year earnings has risen by 14.7% over the past 90 days, indicating a positive trend in analyst sentiment [3] - Alkermes holds a Zacks Rank of 1 (Strong Buy), suggesting strong potential for future performance [3] Group 2: Industry Context - Alkermes is part of the Medical - Biomedical and Genetics industry, which consists of 469 stocks and currently ranks 99 in the Zacks Industry Rank [5] - The Medical - Biomedical and Genetics industry has experienced an average gain of 11.4% this year, indicating that Alkermes is slightly underperforming its industry [5] - In contrast, Cardinal Health, which belongs to the Medical - Dental Supplies industry, has returned 66.4% year-to-date and has a Zacks Rank of 2 (Buy) [4][5]