Revenue and Sales Performance - First quarter revenues of $350.4 million, with total proprietary net sales of $233.5 million[1][3] - LYBALVI revenues grew 50% year-over-year to $57.0 million, with total prescriptions increasing by 56%[5] - Manufacturing and royalty revenues from INVEGA and VUMERITY totaled $94.0 million for the quarter[5] - Total revenues for Q1 2024 increased to $350.4 million, up 21.8% from $287.6 million in Q1 2023[21] Net Income and Profitability - GAAP net income from continuing operations of $38.9 million, compared to a net loss of $12.1 million in the same period last year[4] - Non-GAAP net income from continuing operations of $76.2 million, up from $30.1 million in the first quarter of 2023[4] - Net income from continuing operations improved significantly to $38.9 million, compared to a loss of $12.1 million in Q1 2023[21] - Non-GAAP net income from continuing operations reached $76.2 million, more than double the $30.1 million in Q1 2023[23] Cash and Investments - Cash, cash equivalents, and total investments of $807.8 million as of March 31, 2024, with total debt outstanding of $290.1 million[9] - Cash, cash equivalents, and total investments stood at $807.8 million as of March 31, 2024, slightly down from $813.4 million at the end of 2023[24] Research and Development (R&D) - ALKS 2680 phase 2 study in narcolepsy type 1 initiated, with positive topline phase 1b results in narcolepsy type 2[2][11] - R&D expenses for continuing operations increased to $67.6 million, driven by ALKS 2680 development and share-based compensation[7] - Research and development expenses rose to $67.6 million, up 6.0% from $63.8 million in the prior year period[21] Selling, General, and Administrative (SG&A) Expenses - SG&A expenses for continuing operations rose to $179.7 million, primarily due to LYBALVI advertising and share-based compensation[8] - Selling, general and administrative expenses increased to $179.7 million, up 7.1% from $167.8 million in Q1 2023[21] Share-Based Compensation - Share-based compensation expense increased to $32.8 million, up from $21.0 million in Q1 2023[23] Financial Expectations and Outlook - The company reiterates its 2024 financial expectations as previously announced[10] EBITDA and Operational Performance - EBITDA from continuing operations rose to $51.5 million, up from $7.2 million in the same period last year[22] Assets and Liabilities - Total assets decreased marginally to $2.12 billion from $2.14 billion at the end of 2023[24] Share Structure - Weighted average number of ordinary shares outstanding (diluted) increased to 172,981 from 165,085 in Q1 2023[21]

Core Insights - Alkermes plc has initiated the Vibrance-1 study, a phase 2 clinical trial for ALKS 2680, an investigational oral orexin 2 receptor agonist aimed at treating narcolepsy type 1 (NT1) [1][2] - The study will evaluate the safety and efficacy of ALKS 2680 compared to placebo, with a primary endpoint focused on sleepiness reduction as measured by the maintenance of wakefulness test (MWT) [2][4] - Approximately 80 patients with NT1 will be enrolled across sites in the U.S., Australia, and Europe, with the study expected to last six weeks [2][3] Study Design - Vibrance-1 is a randomized, double-blind, dose-range-finding, placebo-controlled study [2] - Participants will receive one of three doses of ALKS 2680 (4 mg, 6 mg, or 8 mg) or placebo, taken once daily [2] - Secondary endpoints include changes in the Epworth Sleepiness Scale (ESS) score, mean weekly cataplexy rate (WCR), and incidence of adverse events [2] Future Developments - Alkermes plans to initiate Vibrance-2, a phase 2 study for narcolepsy type 2, in the second half of 2024 [3] Company Overview - Alkermes plc is a global biopharmaceutical company focused on developing innovative medicines in neuroscience, with a portfolio addressing various neurological disorders [5] - The company is headquartered in Dublin, Ireland, and has research and manufacturing facilities in the U.S. and Ireland [5]

Alkermes plc (ALKS) has made steady progress with its portfolio of proprietary products — Vivitrol (alcohol and opioid dependence), Aristada (schizophrenia) and Lybalvi (schizophrenia and bipolar I disorder) that are witnessing a steady uptake and driving growth.The continued growth in the alcohol-dependence treatment market has driven new patients toward Vivitrol, while Aristada sales have been driven by underlying demand in recent quarters.Lybalvi (olanzapine and samidorphan), which is approved for the tr ...

Group 1 - Alkermes plc will host a conference call and webcast presentation on May 1, 2024, at 8:00 a.m. ET to discuss its first quarter financial results [1] - The webcast and accompanying slides will be available on the Investors section of Alkermes' website [1] - A replay of the webcast will be accessible approximately two hours after the event [1] Group 2 - Alkermes plc is a global biopharmaceutical company focused on developing innovative medicines in neuroscience [2] - The company has a portfolio of proprietary products for treating alcohol dependence, opioid dependence, schizophrenia, and bipolar I disorder [2] - Alkermes has research and development facilities in Waltham, Massachusetts, and manufacturing facilities in Athlone, Ireland, and Wilmington, Ohio [2]

Core Insights - Alkermes plc announced positive top-line data from a phase Ib study for its oral orexin 2 receptor agonist, ALKS 2680, aimed at treating narcolepsy [1] - The study showed statistically significant improvements in mean sleep latency on the Maintenance of Wakefulness Test across all tested doses [1][2] - Alkermes plans to initiate a phase II study for ALKS 2680 in narcolepsy type 2 (NT2) in the second half of 2024 [2] Study Details - The phase Ib study evaluated ALKS 2680 in narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH) cohorts, focusing on safety, tolerability, pharmacokinetics, and pharmacodynamics [1] - Doses tested in the study included 5 mg, 12 mg, and 25 mg, all showing clinically meaningful results [1][2] Market Context - If approved, ALKS 2680 could significantly change the treatment landscape for narcolepsy, although it may face competition from Axsome's Sunosi [2] - Axsome acquired U.S. rights to Sunosi in May 2022 and began marketing it shortly thereafter, with prior approval received in 2019 [3] - Jazz Pharmaceuticals also has a strong market presence with other sleep disorder drugs, Xyrem and Xywav [3]

MTStock Studio/E+ via Getty Images Alkermes Shows Strong Phase 1 Results for Narcolepsy Treatment ALKS-2680 Alkermes plc (NASDAQ:ALKS) stock hasn't moved much since my last update in November. Back then, I discussed its prospects in narcolepsy ahead of Phase 1 data for its orexin 2 receptor (OX2R) agonist, ALKS-2680. I highlighted the potential for this asset to be differentiated in that it addresses a cause of narcolepsy, rather than simply treating a symptom. I also discussed some historical downfalls of ...

— Orexin 2 Receptor Agonist ALKS 2680 Demonstrated Clinically Meaningful and Statistically Significant Improvements from Baseline in Mean Sleep Latency Compared to Placebo at All Doses Tested in Both Narcolepsy Type 2 and Idiopathic Hypersomnia — — ALKS 2680 Was Generally Well Tolerated at All Doses Tested — — Dose-Dependent Effects and Pharmacodynamic Profile Support Advancement Into Planned Phase 2 Study — DUBLIN, April 9, 2024 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced positive topline r ...

DUBLIN, April 8, 2024 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the oral presentation of clinical data at the 2024 Congress of the Schizophrenia International Research Society (SIRS), which took place April 3-7, 2024 in Florence, Italy. Analyses were presented from a phase 3, open-label extension study assessing the long-term safety, tolerability and durability of treatment effect of LYBALVI® (olanzapine and samidorphan) in patients who received up to four years of treatment. LYBALVI is ap ...

If you are looking for a stock that has a solid history of beating earnings estimates and is in a good position to maintain the trend in its next quarterly report, you should consider Alkermes (ALKS) . This company, which is in the Zacks Medical - Biomedical and Genetics industry, shows potential for another earnings beat.This drugmaker has seen a nice streak of beating earnings estimates, especially when looking at the previous two reports. The average surprise for the last two quarters was 24.90%.For the ...

Investors seek growth stocks to capitalize on above-average growth in financials that help these securities grab the market's attention and produce exceptional returns. But finding a growth stock that can live up to its true potential can be a tough task.By their very nature, these stocks carry above-average risk and volatility. Moreover, if a company's growth story is over or nearing its end, betting on it could lead to significant loss.However, the Zacks Growth Style Score (part of the Zacks Style Scores ...