Core Insights - Alkermes (ALKS) has received Breakthrough Therapy Designation from the FDA for alixorexton, an oral orexin 2 receptor agonist, aimed at treating narcolepsy type 1 (NT1) [1][7] - The Breakthrough Therapy designation is designed to expedite the development and review of therapies for serious diseases with unmet medical needs [1] Company Developments - Alixorexton's Breakthrough Therapy designation is based on positive data from the phase I and phase II Vibrance-1 study, which showed significant improvements in wakefulness compared to placebo [3] - The Vibrance-1 study met its primary endpoint, demonstrating dose-dependent improvements in wakefulness as measured by the Maintenance of Wakefulness Test [3][4] - Treatment with alixorexton also significantly reduced excessive daytime sleepiness at week six, as measured by the Epworth Sleepiness Scale [4] - Alkermes plans to initiate a global phase III program for alixorexton in Q1 2026 [7][10] Market Context - Over the past year, Alkermes' shares have increased by 1.3%, while the industry has seen a rise of 14.2% [2] - Alixorexton is also being studied for narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH), with positive data from the phase II Vibrance-2 study for NT2 announced in November 2025 [8][10] - The Vibrance-2 study showed statistically significant improvements in wakefulness and reductions in excessive daytime sleepiness for NT2 patients [8]

DUBLIN--(BUSINESS WIRE)--Alkermes plc (Nasdaq: ALKS) announced today that its Chief Executive Officer, Richard Pops, will provide a corporate overview and update at the 44th Annual J.P. Morgan Healthcare Conference. The presentation will take place on Tuesday, Jan. 13, 2026 at 10:30 a.m. PST (1:30 p.m. EST/6:30 p.m. GMT). The live webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days. About Alkermes plc Alkermes plc (Nasdaq: ALKS), a mid-cap growth. ...

Alkermes plc (NASDAQ:ALKS) is one of the most promising mid-cap healthcare stocks under $50. At the close of play on December 19, the consensus ratings remain bullish for Alkermes plc (NASDAQ:ALKS). The stock has been covered by 15 analysts, of which 11 assigned it Buy ratings and the remaining 4 were Holds. As per analyst estimates, the forecasted median 1-year price target for the stock is $46.17 a share, resulting in 62.3% upside potential at the prevailing prices. Likoper/Shutterstock.com On Decemb ...

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]

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].

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 FY Conference Summary Company Overview - **Company**: Alkermes (NasdaqGS: ALKS) - **Date of Conference**: December 03, 2025 Key Industry Insights - **Hypersomnia Market**: Alkermes is moving aggressively into the hypersomnia market, which is a new commercial domain for the company after years of focus on other areas [2][3] - **Orexin Receptor Agonist Class**: The landscape of the orexin receptor agonist class is becoming clearer, positioning Alkermes favorably within this setting [3] Financial and Strategic Highlights - **Acquisition of Avadel**: Alkermes intends to acquire Avadel, which has $275 million in sales this year and is already profitable. This acquisition is seen as a strategic move to enhance their position in the hypersomnia market [5][15] - **Valuation Methodology**: The valuation of Avadel was assessed through discounted cash flows and the anticipated positive impact on the launch of ALKS 2680 [5][6] - **Gross-to-Net Dynamics**: Alkermes has a strong understanding of gross-to-net dynamics, which is crucial for assessing the commercial value of their products [8][9] Product Development and Pipeline - **ALKS 2680**: This product is expected to be a significant launch for Alkermes, targeting narcolepsy, a rare disease. The anticipated high price point and medical value are highlighted [12][13] - **Cognition Data**: Alkermes claims to be the only company to show significant effects on cognition and fatigue in a randomized controlled study for orexin, which is critical for patient care in narcolepsy [21][22] - **Future Indications**: The company is exploring multiple indications for orexin beyond narcolepsy, with ongoing clinical trials and a focus on patient populations and pricing strategies [27][28] Research and Development (R&D) Strategy - **R&D Funding**: Alkermes aims to fund its orexin program aggressively while maintaining profitability. The company does not foresee financial constraints in pursuing its R&D goals [34][35] - **Clinical Trials**: The company is preparing for phase three trials for narcolepsy, with a robust data set from phase two studies. The timing for these trials is set for Q1 [41][42] Market Position and Competitive Advantage - **Commercial Infrastructure**: The acquisition of Avadel allows Alkermes to leverage existing commercial infrastructure, enhancing market access and compliance without the need to build a new team from scratch [13][15] - **Dosing Flexibility**: Alkermes plans to offer a range of doses for its products, which could provide a competitive advantage in the market by accommodating different patient needs [44] Conclusion - Alkermes is positioned for significant growth in the hypersomnia market through strategic acquisitions and a strong product pipeline. The company emphasizes its understanding of market dynamics and its commitment to maintaining profitability while expanding its R&D efforts.

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.