Core Insights - The company experienced a transformational year, marking one of the most consequential periods in its history [1] - The acquisition of Avadel and the development of NT1 and NT2 data have positioned the company to enter the hypersomnolence market [1] - The commercial portfolio has performed well, with positive results from NT1 and NT2 data, and ongoing enrollment in the IH study [1] Company Developments - The company has made significant strides in the orexin receptor agonist class, indicating a strong market position [1] - The year has been characterized by key milestones that have enhanced the company's commercial capabilities [1] - The company is optimistic about its future prospects in a new commercial domain after years of preparation [1]

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF THAT JURISDICTION. THIS IS AN ANNOUNCEMENT MADE UNDER RULE 15(C) OF THE IRISH TAKEOVER PANEL ACT, 1997, TAKEOVER RULES, 2022 (THE “IRISH TAKEOVER RULES”) DUBLIN, Dec. 05, 2025 (GLOBE NEWSWIRE) -- As previously announced, the board of directors of Avadel Pharmaceuticals plc (Nasdaq: AVDL), a public limited company incorporated in ...

Summary of Alkermes FY Conference Call (December 04, 2025) Company Overview - **Company**: Alkermes (NasdaqGS:ALKS) - **Focus**: Development of Elixirxton, an orexin 2 receptor agonist for the treatment of narcolepsy (NT1 and NT2) and idiopathic hypersomnia (IH) Key Points Industry Context - **Orexin Receptor Agonists**: Emerging therapeutic category for sleep disorders, particularly narcolepsy and hypersomnolence conditions [1][2][3] Clinical Trial Insights - **Vibrance-1 and Vibrance-2 Studies**: - Vibrance-1 data indicates a high probability of Elixirxton's approval for NT1 [4][5] - Vibrance-2 data shows statistically significant and clinically meaningful changes, supporting the drug's potential for NT2 [6][7] - 70% of patients at the 18-milligram dose achieved normalcy on the Epworth Sleepiness Scale (ESS) [30] Efficacy and Potency - **Efficacy Variability**: - NT2 patients exhibit a wide range of responses, complicating efficacy assessments [27][38] - The study revealed that while some patients did not respond on the Maintenance of Wakefulness Test (MWT), they showed improvement on the ESS [28][30] - **Disease Heterogeneity**: - NT2 is viewed as a distinct condition from NT1, necessitating different treatment approaches [33][38] Dosing Strategy - **Dosing Flexibility**: - Alkermes is considering a range of doses for both NT1 and NT2, with potential for split dosing to enhance patient control over wakefulness [49][60] - A once-daily (QD) dose is expected to be a strong anchor, but flexibility for top-up doses may be beneficial [50][54] - **Phase 3 Trials**: - Decisions on dosing for phase 3 trials have been made, with expectations of 40 to 50 patients per arm [170][166] Competitive Landscape - **Comparison with Competitors**: - Alkermes acknowledges the presence of other orexin receptor agonists, particularly from Takeda, and emphasizes the importance of safety and tolerability in their data [144][155] - Alkermes aims to differentiate through dosing flexibility and a broader range of dosing options [163] Safety and Tolerability - **Safety Profile**: - Vibrance-2 confirmed the safety hypothesis, with no dose-limiting toxicities observed at tested doses [132][60] - The drug is expected to be well-tolerated, with mild to moderate side effects that may attenuate over time [154][159] Future Directions - **IH Study Insights**: - Anticipation of similar efficacy in IH patients based on learnings from NT2 studies [178][182] - The study will focus on the signal of wakefulness using the IH Sleep Scale (IHSS) and ESS as primary endpoints [191][198] Role of Oxybates - **Oxybate Products**: - Alkermes sees a continued role for oxybates in the treatment landscape, particularly for patients who prefer nighttime consolidation of sleep [210][218] - The company acknowledges that not all IH patients will require oxybates, but some may benefit from their use [221] Additional Considerations - **Clinical Measurement Tools**: - The Epworth Sleepiness Scale is widely used but may be supplemented with more specific measures of cognition and fatigue in future studies [123][127] - **Market Potential**: - The overall market for orexin receptor agonists is expected to grow, accommodating multiple drugs and treatment options [144][145] This summary encapsulates the key insights from the Alkermes FY Conference Call, highlighting the company's strategic focus on Elixirxton and its implications for the treatment of narcolepsy and hypersomnolence disorders.

Alkermes (NasdaqGS:ALKS) FY Conference December 03, 2025 02:10 PM ET Company ParticipantsRichard Pops - Chairman and CEOConference Call ParticipantsNone - AnalystNoneOkay, great. Thank you, guys, for joining us. Richard, super excited to have you. I'll let you kick things off. There's a lot going on, so I'll let you start, and I can prioritize accordingly.Richard PopsFirst of all, good to see you. Thanks for having us back, Uber. I was just writing the memo to my board for our last board meeting of the year ...

Core Viewpoint - Alkermes reported strong Q3 earnings and raised its 2025 revenue guidance, despite a recent decline in share price and downward estimate revisions from analysts [2][11][13]. Financial Performance - Alkermes reported earnings from continuing operations of 49 cents per share for Q3 2025, exceeding the Zacks Consensus Estimate of 42 cents and up from 56 cents per share in the same quarter last year [2]. - Total revenues for Q3 reached $394.2 million, a 4% increase year-over-year, significantly surpassing the Zacks Consensus Estimate of $355.7 million [3]. - Sales from proprietary products grew 16% year-over-year to $317.4 million, driven by strong demand for Vivitrol, Aristada, and Lybalvi, exceeding management's expectations of $280-$300 million [5]. Product Sales Breakdown - Vivitrol sales increased 7% year-over-year to $121.1 million, beating the Zacks Consensus Estimate of $112.1 million [6]. - Aristada sales rose 16% year-over-year to $98.1 million, surpassing the Zacks Consensus Estimate of $87 million [7]. - Lybalvi generated sales of $98.2 million, up 32% year-over-year, exceeding the Zacks Consensus Estimate of $87.1 million [8]. Revenue Sources - Alkermes' revenue includes net sales from proprietary products and manufacturing/royalty revenues from partnered products [4]. - Manufacturing and royalty revenues decreased approximately 27% year-over-year to $76.8 million, with specific contributions from Biogen's Vumerity and other products [9]. Expense Overview - Research and development expenses totaled $81.7 million, a 36% increase year-over-year, primarily due to ongoing studies on alixorexton [9]. - Selling, general, and administrative expenses reached $171.8 million, up 14% year-over-year, attributed to the expansion of the psychiatry field organization and increased promotional activities for Lybalvi [10]. 2025 Guidance - Alkermes raised its 2025 revenue guidance to a range of $1.43-$1.49 billion, up from the previous range of $1.34-$1.43 billion [11]. - Expected net sales for Vivitrol are now $460-$470 million, Aristada $360-$370 million, and Lybalvi $340-$350 million for the full year [12]. Market Position and Outlook - Despite a recent downward trend in estimates, Alkermes holds a Zacks Rank 3 (Hold), indicating an expectation of in-line returns in the coming months [15]. - The company has a subpar Growth Score of D but a better Momentum Score of C, with an aggregate VGM Score of B, indicating a favorable position for value investors [14].

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]

Summary of Alkermes Conference Call Company Overview - **Company**: Alkermes - **Event**: Jefferies London Healthcare Conference - **Focus**: Discussion on the orexin class pharmacology and the recent data from the NT2 study Key Points Industry and Product Insights - **Orexin Agonist**: Alkermes is developing Alixorexton, an orexin agonist, which shows promise for treating narcolepsy types NT1 and NT2 [6][9] - **NT2 Study Data**: Recent large dataset from the NT2 study revealed new insights into dose response, safety, and patient adaptation to orexin agonists [6][7] - **Safety Profile**: Contrary to previous beliefs, higher doses did not lead to intolerable side effects, indicating a favorable safety profile [7][9] Clinical Data and Efficacy - **Dose Response**: The study indicated variability in patient responses, with some patients not showing improvement on the MWT (Maintenance of Wakefulness Test) despite improvements in other measures like ESS (Epworth Sleepiness Scale) [14][31] - **Patient Cohorts**: Distinction between responders and non-responders in NT2 population, with the potential for split dosing to enhance efficacy [20][22] - **Secondary Endpoints**: Improvements in cognition and fatigue were noted, suggesting that the drug's benefits extend beyond just wakefulness [31][32] Future Development and Strategy - **Phase Three Trials**: Alkermes is considering the design of phase three studies for NT2 and IH (Idiopathic Hypersomnia), with a focus on split dosing to optimize outcomes [40][41] - **Market Strategy**: The acquisition of Avidel is seen as a strategic move to enhance market presence and leverage relationships with sleep specialists ahead of Alixorexton's launch [49][50] - **Market Potential**: There is a significant gap between the prevalence of narcolepsy and the current treatment rate, indicating potential for market growth with new therapies [50] Investor Considerations - **Confidence in Data**: Alkermes expresses increased confidence in the IH data due to the positive NT2 results, although variability remains a concern [44][41] - **Regulatory Considerations**: The company emphasizes the importance of rigorous study design and statistical planning to ensure reliable outcomes in clinical trials [43][46] Additional Insights - **Comparative Analysis**: Discussion on the differences between orexin agonists and sodium oxybates, highlighting the unique roles each plays in treating narcolepsy [52][53] - **Long-term Vision**: Alkermes is exploring the potential of orexin biology in other indications such as ADHD and Alzheimer's, indicating a broader therapeutic strategy [58][59] This summary encapsulates the key discussions and insights from the Alkermes conference call, focusing on the company's product development, clinical data, market strategy, and investor considerations.

Core Viewpoint - Alkermes has increased its acquisition offer for Avadel Pharmaceuticals, surpassing a competing bid from Lundbeck, with a total valuation of up to $2.37 billion [1] Company Summary - Alkermes is actively pursuing Avadel Pharmaceuticals, indicating a strategic move to enhance its portfolio in the sleep disorder market [1] - Avadel Pharmaceuticals is being valued at up to $2.37 billion, reflecting its potential in the pharmaceutical industry [1] Competitive Landscape - The acquisition bid from Alkermes is positioned against a rival offer from Lundbeck, highlighting competitive dynamics in the pharmaceutical sector [1]

Core Insights - Alkermes Plc (NASDAQ:ALKS) has shown promising clinical trial results for its narcolepsy treatment, Alixorexton, leading to a Buy rating from TD Cowen with a price target of $40 [1][2]. Group 1: Clinical Trial Results - Alixorexton, previously known as ALKS 2680, is in phase 2 development for treating narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH) [2]. - The trial results indicated that 95% of patients completed the 8-week double-masked period, demonstrating a tolerable safety profile [2]. - The drug successfully met its dual primary endpoints, showing clinically meaningful improvements from baseline compared to placebo [2]. Group 2: Future Development Plans - Following the positive topline results, Alkermes plans to initiate a phase 3 program in the first quarter of the next year [4]. Group 3: Company Overview - Alkermes is a global biopharmaceutical company focused on developing and commercializing medicines for central nervous system disorders, including schizophrenia, bipolar I disorder, alcohol dependence, and opioid dependence [5]. - The company utilizes its scientific and proprietary technologies to create a portfolio of commercial products and has a pipeline of investigational drugs targeting neurological and psychiatric conditions [5].

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]