ALKS

— First Large Phase 2 Study of an Orexin 2 Receptor Agonist to Demonstrate Clinically Meaningful and Statistically Significant Improvements in Wakefulness and Excessive Daytime Sleepiness Compared to Placebo in Narcolepsy Type 2 — — Improvements in Wakefulness and Patient-Reported Cognition and Fatigue Were Sustained Through 13 Weeks — — Alixorexton Was Generally Well Tolerated at All Doses Tested — DUBLIN, June 17, 2026--(BUSINESS WIRE)--Alkermes plc (Nasdaq: ALKS) today announced detailed positive results from the Vibrance-2 phase 2 dose-ranging study evaluating alixorexton in patients with narcolepsy type 2 (NT2). Once-daily alixorexton met the study’s dual primary endpoints, demonstrating statistically significant and clinically meaningful improvements from baseline compared to placebo on the Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS) at week eight in adults with NT2 (n=93). Patient-reported improvements in wakefulness were sustained through the five-week open-label extension period. Alixorexton also demonstrated clinically meaningful improvements across exploratory patient-reported outcomes (PROs) evaluating fatigue and cognition. Alixorexton was generally well tolerated at all doses tested (10 mg, 14 mg and 18 mg). Alixorexton is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development for narcolepsy type 1 (NT1), NT2 and idiopathic hypersomnia (IH). Topline results from the Vibrance-2 study were previously announced in November 2025. "The Vibrance-2 results presented at SLEEP provide compelling evidence that alixorexton meaningfully improved measures of wakefulness, fatigue and cognition in patients with narcolepsy type 2. As excitement builds around innovative, potential new treatments, these findings are particularly notable as the first orexin 2 receptor agonist to demonstrate such clinically meaningful benefits in patients with narcolepsy type 2, a population without known orexin deficiency," said Richard K. Bogan, M.D., FCCP, FAASM, Principal of Bogan Sleep Consultants, LLC and Associate Clinical Professor at the University of South Carolina School of Medicine. "Alongside positive Vibrance-1 data in narcolepsy type 1, these results underscore alixorexton’s potential to become an important new treatment option for patients with narcolepsy." Results from Vibrance-2 were presented in an...

In the first quarter of 2026, Alkermes reported a narrower loss than expected and stronger-than-anticipated revenue, helped by higher sales of Vivitrol, Aristada, Lybalvi, and newly acquired Lumryz, while reaffirming its full-year revenue guidance despite increased R&D and acquisition-related costs. At the same time, Alkermes is highlighting an expanding sleep-medicine portfolio, including new Lumryz data and positive Phase 2 results for orexin agonist alixorexton, which could broaden its future treatment footprint in narcolepsy and idiopathic hypersomnia. With these stronger proprietary product trends and growing sleep-medicine data, we'll now examine how this news reshapes Alkermes' investment narrative. Find 49 companies with promising cash flow potential yet trading below their fair value. To own Alkermes today, you have to believe its concentrated psychiatry and emerging sleep portfolio can justify current expectations while funding heavier R&D. The Q1 2026 beat and reaffirmed >US$1.7 billion revenue guidance support that thesis near term, but also underline the key catalyst and risk: execution on the orexin pipeline versus rising R&D and integration costs. The latest results modestly strengthen the short term story, but do not remove the pressure to convert pipeline data into durable earnings. The most relevant new data point is Alkermes’ plan to showcase Lumryz and alixorexton results at SLEEP 2026, including positive Phase 2 Vibrance-2 data in narcolepsy type 2. This directly ties into the orexin program as a central catalyst, with Brilliance Phase 3 trials already underway and Breakthrough Therapy designation in hand. How well this data package ultimately supports regulatory filings and future label expansion will be critical to whether the current optimism proves justified. Yet despite the stronger quarter, investors should be aware that rising R&D and orexin safety and regulatory scrutiny could still... Read the full narrative on Alkermes (it's free!) Alkermes’ narrative projects $2.1 billion revenue and $238.9 million earnings by 2029. This implies 11.8% yearly revenue growth and a small earnings decrease of about $2.8 million from $241.7 million today. Uncover how Alkermes' forecasts yield a $44.24 fair value, a 3% upside to its current price. While consensus focuses on steady progress, the most optimistic analysts were already modeling about US...

A month has gone by since the last earnings report for Revolution Medicines, Inc. (RVMD). Shares have added about 9.3% in that time frame, outperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Revolution Medicines due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the latest earnings report in order to get a better handle on the important drivers. Revolution Medicines reported a first-quarter 2026 loss of $2.29 per share, wider than the Zacks Consensus Estimate of a loss of $1.83. The company had incurred a loss of $1.13 in the year-ago quarter. Currently, the company does not have any approved products in its portfolio. It has yet to generate revenues. Research and development expenses amounted to about $344 million, up 67% year over year. This significant increase was primarily driven by higher costs associated with clinical studies and manufacturing for the company’s drug candidates. General and administrative expenses surged 189% to $101.3 million, primarily driven by higher stock-based compensation expenses, headcount costs and administrative costs, as well as increased commercial preparation activities during the quarter. The company revised its guidance for operating expenses. It expects the figure to be between $1.7 billion and $1.8 billion (previously: $1.6-$1.7 billion), which includes non-cash stock-based compensation expense of $260-$280 million (previously: $180-$200 million). In the past month, investors have witnessed a downward trend in estimates review. The consensus estimate has shifted -8.19% due to these changes. At this time, Revolution Medicines has a poor Growth Score of F, a grade with the same score on the momentum front. Following the exact same course, the stock has a score of F on the value side, putting it in the bottom 20% quintile for this investment strategy. Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Notably, Revolution Medicines has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Revolution Medicines is part of the Zacks Medical - Biome...

It has been about a month since the last earnings report for Alkermes (ALKS). Shares have added about 21.1% in that time frame, outperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Alkermes due for a pullback? Well, first let's take a quick look at its most recent earnings report in order to get a better handle on the recent catalysts for Alkermes plc before we dive into how investors and analysts have reacted as of late. Alkermes reported a loss of 40 cents per share for the first quarter of 2026, which was narrower than the Zacks Consensus Estimate of a loss of 57 cents. The company had recorded earnings of 13 cents per share in the year-ago quarter. The company reported total revenues of $392.9 million for the first quarter, which increased 28.2% from the year-ago quarter owing to higher product sales. The top line also beat the Zacks Consensus Estimate of $359 million. Alkermes derives revenues from the net sales of its proprietary products — Vivitrol (alcohol and opioid dependence), Aristada (schizophrenia), Lybalvi (schizophrenia and bipolar I disorder) and newly acquired sleep disorder drug, Lumryz. The metric also includes manufacturing and/or royalty revenues on net sales of products commercialized by partners. Sales of the proprietary products portfolio grew 38.3% year over year to $338.1 million during the first quarter, driven by solid demand across the commercial portfolio. Sales of proprietary products were above management’s guided range of $300-$320 million. Vivitrol sales increased 11.3% year over year to $112.4 million in the reported quarter. The metric beat the Zacks Consensus Estimate of $103 million. Aristada sales increased 27.6% year over year to $93.8 million. The figure beat the Zacks Consensus Estimate of $78 million. Lybalvi generated sales of $92.4 million, up 32% year over year in the reported quarter, due to increased total prescriptions. Its sales beat the Zacks Consensus Estimate of $87 million. Lybalvi’s total prescriptions grew 21% year over year in the quarter. Lumryz recorded revenues worth $39.5 million in the period from Feb. 12, 2026, to March 31, 2026. Total manufacturing and royalty revenues decreased around 11.6% year over year to $54.8 million. Manufacturing and royalty revenues from Biogen’s multiple sclerosis drug, Vumerity, were $27.3 million. Royalty...

Shareholders appeared unconcerned with Alkermes plc's (NASDAQ:ALKS) lackluster earnings report last week. We think that the softer headline numbers might be getting counterbalanced by some positive underlying factors. Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. To properly understand Alkermes' profit results, we need to consider the US$48m expense attributed to unusual items. It's never great to see unusual items costing the company profits, but on the upside, things might improve sooner rather than later. We looked at thousands of listed companies and found that unusual items are very often one-off in nature. And that's hardly a surprise given these line items are considered unusual. Assuming those unusual expenses don't come up again, we'd therefore expect Alkermes to produce a higher profit next year, all else being equal. That might leave you wondering what analysts are forecasting in terms of future profitability. Luckily, you can click here to see an interactive graph depicting future profitability, based on their estimates. Because unusual items detracted from Alkermes' earnings over the last year, you could argue that we can expect an improved result in the current quarter. Based on this observation, we consider it likely that Alkermes' statutory profit actually understates its earnings potential! On the other hand, its EPS actually shrunk in the last twelve months. The goal of this article has been to assess how well we can rely on the statutory earnings to reflect the company's potential, but there is plenty more to consider. So if you'd like to dive deeper into this stock, it's crucial to consider any risks it's facing. For example, we've found that Alkermes has 2 warning signs (1 is potentially serious!) that deserve your attention before going any further with your analysis. This note has only looked at a single factor that sheds light on the nature of Alkermes' profit. But there are plenty of other ways to inform your opinion of a company. For example, many people consider a high return on equity as an indication of favorable business economics, while others like to 'follow the money' and search out stocks that insiders are buying. So you may wish to see this free collection of companies boasting high return on equity, or this list of stocks with high insider ownership...

– LUMRYZ Met All Primary and Key Secondary Endpoints Demonstrating Statistically Significant and Clinically Meaningful Improvements Compared to Placebo in Excessive Daytime Sleepiness and Patient-Reported Disease Severity – – Safety Profile Consistent With Known Safety Profile of LUMRYZ – DUBLIN, May 12, 2026--(BUSINESS WIRE)--Alkermes plc (Nasdaq: ALKS) today announced positive topline results from the REVITALYZ℠ double-blind, placebo-controlled, randomized withdrawal, multicenter phase 3 study evaluating the investigational use of LUMRYZ® (sodium oxybate) extended-release oral suspension in adults with idiopathic hypersomnia (IH). LUMRYZ met the study’s primary endpoint, demonstrating statistically significant improvements in excessive daytime sleepiness compared to placebo as measured by the change in Epworth Sleepiness Scale (ESS)1 score (p<0.0001). "The data from REVITALYZ demonstrate the potential utility of once-nightly LUMRYZ as an effective treatment for excessive daytime sleepiness associated with IH, building upon its established therapeutic value in narcolepsy," said Richard K. Bogan, M.D., FCCP, FAASM, Principal of Bogan Sleep Consultants, LLC and Associate Clinical Professor at the University of South Carolina School of Medicine. "This is a community with limited approved therapeutic options. These findings constitute an important contribution to the clinical understanding of treatment approaches for patients with IH, for whom disruptive symptoms present particular treatment challenges." All study participants received LUMRYZ during an open-label dose titration period then a stable dose period, during which improvements in ESS scores were observed. At the end of the stable dose period participants were randomized to remain on LUMRYZ or switch to placebo. At the end of the double-blind randomized withdrawal period, the primary endpoint of ESS and key secondary endpoints of Patient Global Impression of Change (PGI-C)2 and Idiopathic Hypersomnia Severity Scale (IHSS)3 were measured for 104 participants to assess the worsening of symptoms for those participants on placebo as compared to those that remained on LUMRYZ. From the end of the stable dose period to the end of the double-blind randomized withdrawal period, participants randomized to placebo had statistically significant worsening in ESS (p<0.0001), PGI-C (p<0.0001), and IHSS (p<0.0001) com...

Alkermes plc ALKS reported a loss of 40 cents per share for the first quarter of 2026, which was narrower than the Zacks Consensus Estimate of a loss of 57 cents. The company had recorded earnings of 13 cents per share in the year-ago quarter. The company reported total revenues of $392.9 million for the first quarter, which increased 28.2% from the year-ago quarter owing to higher product sales. The top line also beat the Zacks Consensus Estimate of $359 million. Owing to the better-than-expected first-quarter results, ALKS’ shares were up 6.1% yesterday. The stock has rallied 29.5% in the year-to-date period against the industry’s decline of 2.4%. Image Source: Zacks Investment Research Alkermes derives revenues from the net sales of its proprietary products — Vivitrol (alcohol and opioid dependence), Aristada (schizophrenia), Lybalvi (schizophrenia and bipolar I disorder) and newly acquired sleep disorder drug, Lumryz. The metric also includes manufacturing and/or royalty revenues on net sales of products commercialized by partners. Sales of the proprietary products portfolio grew 38.3% year over year to $338.1 million during the first quarter, driven by solid demand across the commercial portfolio. Sales of proprietary products were above management’s guided range of $300-$320 million. Vivitrol sales increased 11.3% year over year to $112.4 million in the reported quarter. The metric beat the Zacks Consensus Estimate of $103 million. Aristada sales increased 27.6% year over year to $93.8 million. The figure beat the Zacks Consensus Estimate of $78 million. Lybalvi generated sales of $92.4 million, up 32% year over year in the reported quarter, due to increased total prescriptions. Its sales beat the Zacks Consensus Estimate of $87 million. Lybalvi’s total prescriptions grew 21% year over year in the quarter. In February 2026, Alkermes completed the previously announced acquisition of Ireland-based Avadel Pharmaceuticals, which added the latter’s FDA-approved product, Lumryz, to its commercial portfolio. Lumryz is approved as the first and only once-at-bedtime oxybate for extended-release oral suspension for the treatment of cataplexy or excessive daytime sleepiness in patients aged seven years and older with narcolepsy. Lumryz recorded revenues worth $39.5 million in the period from Feb. 12, 2026, to March 31, 2026. Total manufacturing and royalty revenu...

Image source: The Motley Fool. Tuesday, May 5, 2026 at 8 a.m. ET Chairman & Chief Executive Officer — Richard F. Pops Chief Commercial Officer — Todd Nichols Chief Financial Officer — Joshua Reed Executive Vice President, Corporate Development & Strategy — Blair Jackson Senior Vice President, Investor Relations — Sandra Coombs Need a quote from a Motley Fool analyst? Email [email protected] During the quarter, we closed the acquisition of Avadel Pharmaceuticals plc. The financial results announced today reflect the mid-February closing of the transaction and the integration of Avadel into our business, including 6 weeks of contribution from LUMRYZ, Avadel's once-at-bedtime sodium oxybate for the treatment of narcolepsy. Our discussions during this conference call will include forward-looking statements. Actual results could differ materially from these forward-looking statements. Please see Slide 2 of the accompanying presentation, our press release issued this morning and our most recent annual report filed with the SEC for important risk factors that could cause our actual results to differ materially from those expressed or implied in the forward-looking statements. We undertake no obligation to update or revise the information provided on this call or in the accompanying presentation as a result of new information or future results or developments. After our prepared remarks, we'll open the call for Q&A, and I'll turn the call over to Richard for some opening remarks. Richard F. Pops: Thank you, and good morning, everyone. So, we had an excellent financial first quarter with another strong period of commercial execution and business performance. The quarter was consequential in other ways. Perhaps most significantly, we completed the acquisition of Avadel, a key element of our strategy to become a leader in the sleep medicine space. With LUMRYZ, we add a new differentiated medicine to our portfolio, one that's early in its commercial life and has significant potential for growth. LUMRYZ addresses a clearly defined patient need and fits logically into our portfolio, consistent with our focus on medicines delivering meaningful clinical benefit to patients. From a financial standpoint, the acquisition further enhances our financial growth and provides additional resources and flexibility to advance our development portfolio. Beyond the financial consideration, th...

The acquisition of Avadel Pharmaceuticals and its once-nightly narcolepsy treatment, LUMRYZ, establishes an immediate commercial footprint in sleep medicine ahead of future pipeline launches. Proprietary product net sales grew 38% year-over-year, driven by strong demand in psychiatry and addiction franchises alongside favorable gross-to-net adjustments. Management views Eli Lilly's entry into the orexin space as external validation of the pathway's broad scientific and commercial potential beyond sleep disorders. The commercial organization has evolved into three distinct categories: addiction (VIVITROL), psychiatry (ARISTADA/LYBALVI), and sleep medicine (LUMRYZ). Strategic positioning in sleep medicine is intended to build relationships with specialists now to accelerate the potential future launch trajectory of Alixorexton. Performance in the VIVITROL franchise continues to be driven by localized market dynamics across specific states and payer systems. The company maintains a focus on disciplined execution and increasing scale to drive shareholder value through a diversified portfolio of differentiated medicines. The Alixorexton Phase III Brilliance program is now enrolling narcolepsy type 1 and type 2 patients, with a focus on high-quality execution to support competitive positioning. Expansion into ADHD and fatigue represents a strategic pivot to leverage Orexin 2 receptor agonists in populations with intact orexin systems. Full-year 2026 guidance for LUMRYZ net sales is set at $350 million to $370 million, with Alkermes recording the portion following the mid-February acquisition close. Management expects to pay down the $1.525 billion term loan quickly using significant operating cash flows generated by the expanded business. The Vibrance-3 Phase II study in idiopathic hypersomnia is on track for completion in Q4 2026, including a split-dose cohort to evaluate wakefulness durability. Refinements to purchase price accounting for the Avadel acquisition improved full-year GAAP net loss and EBITDA expectations due to lower non-cash expense estimates. The 2026 cost of goods sold includes a $105 million inventory fair value step-up charge related to LUMRYZ inventory held at the time of closing. Management noted that while Teva may enter the VIVITROL market in 2027, they do not expect typical generic erosion due to the product's complex manufacturing and hig...

DUBLIN, May 05, 2026--(BUSINESS WIRE)--Alkermes plc (Nasdaq: ALKS) today reported financial results for the quarter ended March 31, 2026 and financial expectations for full year 2026. To view the detailed first quarter 2026 earnings press release and presentation, please visit the company’s investor relations website at https://investor.alkermes.com. Alkermes will host a conference call and webcast presentation at 8:00 a.m. ET (1:00 p.m. BST) today to discuss these financial results and expectations and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at https://investor.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes’ website. About Alkermes plc Alkermes plc, a mid-cap growth and value equity, is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy. Alkermes’ pipeline includes late-stage clinical candidates in development for narcolepsy and idiopathic hypersomnia, and orexin 2 receptor agonists in early clinical development for other neurological disorders, including attention-deficit hyperactivity disorder (ADHD) and fatigue associated with multiple sclerosis and Parkinson’s disease. Headquartered in Ireland, Alkermes also has a corporate office and research and development center in Massachusetts and a manufacturing facility in Ohio. For more information, please visit Alkermes’ website at www.alkermes.com. View source version on businesswire.com: https://www.businesswire.com/news/home/20260505070171/en/ Contacts Alkermes Contacts: For Investors: Sandy Coombs +1 781 609 6377 For Media: Katie Joyce +1 781 249 8927

For the quarter ended March 2026, Alkermes (ALKS) reported revenue of $392.91 million, up 28.2% over the same period last year. EPS came in at -$0.40, compared to $0.13 in the year-ago quarter. The reported revenue compares to the Zacks Consensus Estimate of $358.83 million, representing a surprise of +9.5%. The company delivered an EPS surprise of +30.31%, with the consensus EPS estimate being -$0.57. While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wall Street expectations to determine their next course of action, some key metrics always provide a better insight into a company's underlying performance. As these metrics influence top- and bottom-line performance, comparing them to the year-ago numbers and what analysts estimated helps investors project a stock's price performance more accurately. Here is how Alkermes performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts: Revenues- Proprietary Sales- ARISTADA: $93.8 million versus the two-analyst average estimate of $77.95 million. The reported number represents a year-over-year change of +27.6%. Revenues- Manufacturing and Royalty Revenues- VUMERITY: $27.3 million versus the two-analyst average estimate of $21.8 million. The reported number represents a year-over-year change of -1.8%. Revenues- Product sales, net: $338.11 million compared to the $306.85 million average estimate based on two analysts. The reported number represents a change of +38.3% year over year. Revenues- Proprietary Sales- VIVITROL: $112.4 million versus the two-analyst average estimate of $102.5 million. The reported number represents a year-over-year change of +11.3%. Revenues- Manufacturing and Royalty revenues: $54.8 million versus $47.3 million estimated by two analysts on average. Compared to the year-ago quarter, this number represents a -11.6% change. Revenues- Proprietary Sales- LYBALVI: $92.4 million versus $86.9 million estimated by two analysts on average. Compared to the year-ago quarter, this number represents a +32% change. View all Key Company Metrics for Alkermes here>>> Shares of Alkermes have returned +0.3% over the past month versus the Zacks S&P 500 composite's +9.5% change. The stock currently has a Zacks Rank #3 (Hold), indicating that it could perform in line with the bro...

DUBLIN (AP) — DUBLIN (AP) — Alkermes PLC (ALKS) on Tuesday reported a first-quarter loss of $66.5 million, after reporting a profit in the same period a year earlier. The Dublin-based company said it had a loss of 40 cents per share. The results topped Wall Street expectations. The average estimate of five analysts surveyed by Zacks Investment Research was for a loss of 57 cents per share. The drugmaker posted revenue of $392.9 million in the period, also beating Street forecasts. Four analysts surveyed by Zacks expected $358.8 million. Alkermes shares have increased 22% since the beginning of the year. The stock has climbed 7.5% in the last 12 months. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on ALKS at https://www.zacks.com/ap/ALKS