1. DUBLIN, Feb. 18, 2021 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) announced today that management will participate in a virtual fireside chat at the SVB Leerink Global Healthcare Conference on Wednesday, Feb. 24, 2021 at 9:20 a.m. ET (2:20 p.m. GMT). The presentation may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

    About Alkermes plc

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and…

    DUBLIN, Feb. 18, 2021 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) announced today that management will participate in a virtual fireside chat at the SVB Leerink Global Healthcare Conference on Wednesday, Feb. 24, 2021 at 9:20 a.m. ET (2:20 p.m. GMT). The presentation may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

    About Alkermes plc

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    Contact:

    Alex Braun

    Investor Relations

    +1 781 296 8493

     

    Alkermes plc Logo (PRNewsfoto/Alkermes plc)

     

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    SOURCE Alkermes plc

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  2. DUBLIN, Feb. 11, 2021 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today reported financial results for the quarter and year ended Dec. 31, 2020 and provided financial expectations for 2021.

    "2020 was a demonstration of the resiliency of our organization, as we adapted our business to endure a pandemic that has proved to be one of the most disruptive events in our recent history. Despite the challenges posed by COVID-19, we achieved significant growth of net sales from our portfolio of proprietary commercial products, advanced our pipeline of neuroscience and oncology candidates, and announced a Value Enhancement Plan designed to drive growth and improve operational and financial performance," said Richard Pops, Chief Executive Officer of Alkermes…

    DUBLIN, Feb. 11, 2021 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today reported financial results for the quarter and year ended Dec. 31, 2020 and provided financial expectations for 2021.

    "2020 was a demonstration of the resiliency of our organization, as we adapted our business to endure a pandemic that has proved to be one of the most disruptive events in our recent history. Despite the challenges posed by COVID-19, we achieved significant growth of net sales from our portfolio of proprietary commercial products, advanced our pipeline of neuroscience and oncology candidates, and announced a Value Enhancement Plan designed to drive growth and improve operational and financial performance," said Richard Pops, Chief Executive Officer of Alkermes. "We are focused on value creation in 2021 as we seek to grow and diversify our commercial portfolio, demonstrate the value of our R&D investments, and manage the company for growth and long-term profitability, all while striving to make a meaningful difference in the lives of people living with serious mental illness, addiction and cancer."

    Quarter Ended Dec. 31, 2020 Financial Highlights

    • Total revenues for the quarter were $280.0 million. This compared to $412.7 million for the same period in the prior year, which included a $150.0 million milestone payment from Biogen related to the U.S. Food and Drug Administration's (FDA) approval of VUMERITY® in 2019.
    • Net loss according to generally accepted accounting principles in the U.S. (GAAP) was $42.6 million for the quarter, or a basic and diluted GAAP loss per share of $0.27. This compared to GAAP net loss of $5.4 million, or a basic and diluted GAAP loss per share of $0.03, for the same period in the prior year.
    • Non-GAAP net income was $16.5 million for the quarter, or a non-GAAP basic and diluted earnings per share of $0.10. This compared to non-GAAP net income of $131.4 million, or a non-GAAP basic and diluted earnings per share of $0.83 for the same period in the prior year.

    Year Ended Dec. 31, 2020 Financial Results

    Revenues

    • Total revenues for the year were $1.04 billion. This compared to $1.17 billion in the prior year. Total revenues in 2019 included a $150.0 million milestone payment from Biogen related to the FDA's approval of VUMERITY, of which $144.8 million was recorded as license revenue and $5.2 million was recorded as research and development (R&D) revenue.
    • Net sales of proprietary products for the year were $551.8 million, compared to $524.5 million in the prior year.
      • Net sales of VIVITROL® were $310.7 million, compared to $335.4 million in the prior year, representing a decrease of approximately 7%, primarily due to COVID-19-pandemic-related disruptions.
      • Net sales of ARISTADA®i were $241.0 million, compared to $189.1 million in the prior year, representing an increase of approximately 27%.
    • Manufacturing and royalty revenues for the year were $484.0 million, compared to $447.9 million in the prior year.
      • Manufacturing and royalty revenues from RISPERDAL CONSTA®, INVEGA SUSTENNA®/XEPLION® and INVEGA TRINZA®/TREVICTA® were $345.6 million, compared to $323.3 million in the prior year.

    Costs and Expenses

    • Total operating expenses for the year were $1.15 billion, compared to $1.35 billion in the prior year.
      • R&D expenses were $394.6 million, compared to $512.8 million in the prior year, which included the $86.6 million charge related to the acquisition of Rodin Therapeutics, Inc. (Rodin) in 2019.
      • Selling, General and Administrative (SG&A) expenses were $538.8 million, compared to $599.4 million in the prior year, primarily reflecting the impact of the restructuring implemented in 2019 and additional expense management measures in 2020.

    Net Loss/Net Income

    • GAAP net loss for the year was $110.9 million, or a basic and diluted GAAP loss per share of $0.70. This compared to GAAP net loss of $196.6 million, or a basic and diluted GAAP loss per share of $1.25, in the prior year.
    • Non-GAAP net income for the year was $68.6 million, or a non-GAAP basic and diluted earnings per share of $0.43. This compared to non-GAAP net income of $112.2 million, or a non-GAAP basic and diluted earnings per share of $0.71, in the prior year, which included the $150 million of revenue from Biogen following approval of VUMERITY.

    Balance Sheet

    • At Dec. 31, 2020, Alkermes recorded cash, cash equivalents and total investments of $659.8 million, compared to $597.2 million at Sept. 30, 2020, and $614.4 million at Dec. 31, 2019, driven primarily by the company's operating results and changes in working capital. The company's total debt outstanding as of Dec. 31, 2020 was $275.0 million, consisting of a term loan that matures in March 2023.

    "Our solid 2020 financial results demonstrate efficient management of our business from a financial and operational perspective in response to the significant disruptions caused by the pandemic. These efforts underscore our focus on execution and reflect our commitment to driving bottom line growth," commented Iain Brown, Chief Financial Officer of Alkermes. "We enter 2021 well positioned to execute on our strategic priorities and work toward the long-term profitability margin targets set forth in our Value Enhancement Plan. We plan to achieve these targets through commercial execution, focused investment in the company's future growth drivers and continued efforts to optimize our infrastructure and operating model. Our financial expectations for 2021 reflect anticipated growth of our commercial portfolio and focused investments to support the anticipated launch of LYBALVI™ and advance the clinical development program for nemvaleukin, as we position these programs to drive future value creation."

    Financial Expectations for 2021

    The following financial expectations for 2021 are based on recent trends and assume continuation of such trends into the first half of the year, and an anticipated improvement in patient access to treatment providers and to the company's commercial products in the second half of the year. If patient access does not improve as anticipated, or if new COVID-19-related disruptions emerge, the company's ability to meet these expectations could be negatively impacted. All line items are according to GAAP, except as otherwise noted.

    In millions (except per share amounts)



    2021 Expectation

    (Provided 2/11/21)







    Total Revenue



    $1,100 – $1,170

    VIVITROL Net Sales



    $315 – $345

    ARISTADA Net Sales



    $260 – $290

    LYBALVI Net Sales



    <$10

    Cost of Goods Sold



    $190 – $200

    R&D Expenses



    $400 – $430*

    SG&A Expenses



    $570 – $600

    Amortization of Intangible Assets



    ~$40

    Income Tax Expense



    $0 – $10

    GAAP Net Loss



    ($85) – ($125)

    GAAP Net Loss per Share



    ($0.53) – ($0.78)

    Non-GAAP Net Income



    $60 – $100

    Non-GAAP Diluted EPS



    $0.37 – $0.62

    Capital Expenditures



    ~$40

    *R&D expense expectations for 2021 include a potential $25 million milestone payment to the former shareholders of Rodin related to the anticipated submission of an investigational new drug application, or equivalent, for ALKS 1140, the first clinical candidate to emerge from the histone deacetylase (HDAC) inhibitor platform acquired by the company in late 2019.

    Recent Events:

    LYBALVI (formerly referred to as ALKS 3831)

    • In December 2020, the FDA acknowledged receipt of the company's New Drug Application (NDA) resubmission for LYBALVI and assigned the application a new Prescription Drug User Fee Act (PDUFA) target action date of June 1, 2021. Subsequent to Alkermes' resubmission of the NDA, the FDA issued a new request for records under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act to supplement the information previously provided by the company. The resubmission and records request followed the company's receipt of a Complete Response Letter (CRL) from the FDA in November 2020 following its remote review of records relating to the manufacture of LYBALVI at the company's Wilmington, OH facility. The CRL did not identify or raise any concerns about the clinical or non-clinical data in the NDA and the FDA has not asked the company to complete any new clinical trials to support approval of the application.

    Nemvaleukin alfa ("nemvaleukin", formerly referred to as ALKS 4230)

    • In November 2020, preliminary data from ARTISTRY-1 and ARTISTRY-2, phase 1/2 studies evaluating nemvaleukin administered intravenously and subcutaneously, respectively, as monotherapy and in combination with pembrolizumab in patients with refractory advanced solid tumors, were presented at the Society for Immunotherapy of Cancer's (SITC) 35th Anniversary Annual Meeting.

    HDAC-inhibitor platform

    • In December 2020, the company nominated ALKS 1140, a novel CoRESTii-selective HDAC inhibitor candidate with potential applications in neuropsychiatric indications. First-in-human studies for ALKS 1140 are planned to begin in 2021.

    Other

    • In January 2021, results from a National Institute on Drug Abuse (NIDA)-funded study evaluating the efficacy and safety of naltrexone for extended-release injectable suspension (XR-NTX) administered once every three weeks plus oral extended-release bupropion administered daily as a combination treatment for adults with moderate or severe methamphetamine use disorder (MUD) were published by Dr. Madhukar H. Trivedi et al. in the New England Journal of Medicine (NEJM).iii

    Corporate

    • In December 2020, the company announced a Value Enhancement Plan designed to drive growth, improve operational and financial performance and enhance shareholder value. The plan includes a commitment to multi-year profitability targets, a review and optimization of the company's cost structure and potential monetization of non-core assets.
    • In December 2020, two new, independent directors joined the company's board of directors (Board). David Daglio brings to the Board more than 20 years of experience in institutional investment management, and Brian McKeon brings strong financial and management expertise as well as public company executive and director experience.
    • In January 2021, Blair C. Jackson was appointed Chief Operating Officer and Iain M. Brown was named Chief Financial Officer. They will oversee the company's implementation of the Value Enhancement Plan.

    Conference Call

    Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. GMT) on Thursday, Feb. 11, 2021, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes' website at www.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 will be available from 11:00 a.m. ET (4:00 p.m. GMT) on Thursday, Feb. 11, 2021, through Thursday, Feb. 18, 2021, and may be accessed by visiting Alkermes' website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay conference ID is 13715619.

    About Alkermes plc

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    Non-GAAP Financial Measures

    This press release includes information about certain financial measures that are not prepared in accordance with GAAP, including non-GAAP net income (loss) and non-GAAP basic and diluted earnings (loss) per share. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies.

    Non-GAAP net income (loss) adjusts for one-time and non-cash charges by excluding from GAAP results: share-based compensation expense; amortization; depreciation; non-cash net interest expense; certain other one-time or non-cash items; and the income tax effect of these reconciling items.

    The company's management and board of directors utilize these non-GAAP financial measures to evaluate the company's performance. The company provides these non-GAAP measures of the company's performance to investors because management believes that these non-GAAP financial measures, when viewed with the company's results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, non-GAAP net income (loss) and non-GAAP basic and diluted earnings (loss) per share are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, non-GAAP net income (loss) and non-GAAP basic and diluted earnings (loss) per share should not be considered measures of our liquidity.

    A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release.

    Note Regarding Forward-Looking Statements

    Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company's expectations concerning future financial and operating performance, business plans or prospects, including the expected drivers of future value creation, expectations of revenue growth and diversification of the company's commercial portfolio and the anticipated improvement in patient access to healthcare providers and to the company's commercial products; the company's ability to execute on its strategic priorities and plans to manage for long-term profitability through execution of its Value Enhancement Plan, including through the achievement of multi-year profitability targets, review and optimization of its cost structure and potential monetization of non-core assets; the potential therapeutic and commercial value of the company's marketed and development products; the FDA's target PDUFA action date for, and potential approval of, the NDA for LYBALVI; expectations concerning future development activities, including advancement of the nemvaleukin development program and the anticipated submission of an IND or equivalent for ALKS 1140 and plans to initiate related studies; and expectations concerning the company's commercial activities, including investments to support the anticipated launch of LYBALVI. The company cautions that forward-looking statements are inherently uncertain. The forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: the company's cost structure review and optimization may not yield the intended results; the company may not be able to achieve its targeted profitability metrics in a timely manner or at all; the impacts of the ongoing COVID-19 pandemic and continued efforts to mitigate its spread on the company's business, results of operations or financial condition, including impacts on healthcare systems that serve people living with opioid dependence, alcohol dependence and schizophrenia and on patient and healthcare provider access to the company's commercial products and impacts on the regulatory agencies with which the company interacts in the development, review, approval and commercialization of its medicines; the unfavorable outcome of litigation, including so-called "Paragraph IV" litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and the adequacy of the data and other information included in our submissions to support the FDA's requirements for approval; clinical development activities may not be completed on time or at all; the results of the company's development activities may not be positive, or predictive of real-world results or of results in subsequent trials, and preliminary or interim results of the company's development activities may not be predictive of final results of such activities, results of future preclinical or clinical trials or real-world results; regulatory submissions may not occur or be submitted in a timely manner;  the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products, such as decisions not to approve the company's NDAs, including the NDA for LYBALVI; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2020 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission ("SEC"), which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

    VIVITROL® is a registered trademark of Alkermes, Inc.; ARISTADA® and ARISTADA INITIO® are registered trademarks of Alkermes Pharma Ireland Limited; LYBALVITM is a trademark of Alkermes Pharma Ireland Limited; RISPERDAL CONSTA®, INVEGA SUSTENNA®, XEPLION®, INVEGA TRINZA® and TREVICTA® are registered trademarks of Johnson & Johnson; and VUMERITY® is a registered trademark of Biogen Inc., used by Alkermes under license.

    (tables follow)

    Alkermes plc and Subsidiaries

    Selected Financial Information (Unaudited)











    Condensed Consolidated Statements of Operations - GAAP



    Three Months Ended 



    Three Months Ended 

    (In thousands, except per share data)



    December 31, 2020



    December 31, 2019

    Revenues:









    Product sales, net



    $                  148,961



    $                  149,609

    Manufacturing and royalty revenues



    130,893



    107,287

    Research and development revenue



    141



    11,084

    License revenue





    144,750

    Total Revenues



    279,995



    412,730

    Expenses:









    Cost of goods manufactured and sold



    42,922



    46,482

    Research and development



    112,107



    198,157

    Selling, general and administrative



    145,778



    154,453

    Amortization of acquired intangible assets



    9,917



    10,171

    Restructuring expense





    13,401

    Total Expenses



    310,724



    422,664

    Operating Loss



    (30,729)



    (9,934)

    Other (Expense) Income, net:









    Interest income



    1,036



    3,191

    Interest expense



    (1,869)



    (3,196)

    Change in the fair value of contingent consideration



    (12,681)



    5,000

    Other income, net



    2,597



    2,382

    Total Other (Expense) Income, net



    (10,917)



    7,377

    Loss Before Income Taxes



    (41,646)



    (2,557)

    Provision for Income Taxes



    996



    2,797

    Net Loss — GAAP



    $                  (42,642)



    $                    (5,354)











    (Loss) Earnings Per Share:









    GAAP loss per share — basic and diluted



    $                      (0.27)



    $                      (0.03)

    Non-GAAP earnings per share — basic and diluted



    $                        0.10



    $                        0.83











    Weighted Average Number of Ordinary Shares Outstanding:









    Basic and diluted — GAAP



    159,153



    157,662

    Basic — Non-GAAP



    159,153



    157,662

    Diluted — Non-GAAP



    161,267



    159,073











    An itemized reconciliation between net loss on a GAAP basis and non-GAAP net income is as follows:

    Net Loss — GAAP



    $                  (42,642)



    $                    (5,354)

    Adjustments:









    Share-based compensation expense



    24,884



    21,387

    Depreciation expense



    10,411



    10,340

    Amortization expense



    9,917



    10,171

    Income tax effect related to reconciling items



    1,121



    592

    Non-cash net interest expense



    166



    168

    Change in the fair value of contingent consideration



    12,681



    (5,000)

    Change in the fair value of warrants





    (930)

    Acquisition of IPR&D





    86,595

    Restructuring expense





    13,401

    Non-GAAP Net Income



    $                    16,538



    $                  131,370





















    Condensed Consolidated Statements of Operations - GAAP



    Year Ended 



    Year Ended 

    (In thousands, except per share data)



    December 31, 2020



    December 31, 2019

    Revenues:









    Product sales, net



    $                  551,760



    $                  524,499

    Manufacturing and royalty revenues



    484,000



    447,882

    Research and development revenue



    1,946



    52,816

    License revenue



    1,050



    145,750

    Total Revenues



    1,038,756



    1,170,947

    Expenses:









    Cost of goods manufactured and sold



    178,316



    180,385

    Research and development



    394,588



    512,833

    Selling, general and administrative



    538,827



    599,449

    Amortization of acquired intangible assets



    39,452



    40,358

    Restructuring expense





    13,401

    Total Expenses



    1,151,183



    1,346,426

    Operating Loss



    (112,427)



    (175,479)

    Other Income (Expense), net:









      Interest income



    6,960



    13,976

      Interest expense



    (8,659)



    (13,601)

      Change in the fair value of contingent consideration



    3,945



    (22,800)

      Other income, net



    13,644



    848

    Total Other Income (Expense), net



    15,890



    (21,577)

    Loss Before Income Taxes



    (96,537)



    (197,056)

    Provision (Benefit) for Income Taxes



    14,324



    (436)

    Net Loss — GAAP



    $                (110,861)



    $                (196,620)











    (Loss) Earnings Per Share:









    GAAP loss per share — basic and diluted



    $                      (0.70)



    $                      (1.25)

    Non-GAAP earnings per share — basic and diluted



    $                        0.43



    $                        0.71











    Weighted Average Number of Ordinary Shares Outstanding:









    Basic and diluted — GAAP



    158,803



    157,051

    Basic — Non-GAAP



    158,803



    157,051

    Diluted — Non-GAAP



    159,861



    159,056











    An itemized reconciliation between net loss on a GAAP basis and non-GAAP net income is as follows:

    Net Loss — GAAP



    $                (110,861)



    $                (196,620)

    Adjustments:









    Share-based compensation expense



    90,161



    100,977

    Depreciation expense



    42,402



    40,055

    Amortization expense



    39,452



    40,358

    Income tax effect related to reconciling items



    10,092



    5,762

    Non-cash net interest expense



    666



    673

    Change in the fair value of contingent consideration



    (3,945)



    22,800

    Change in the fair value of warrants





    (1,837)

    Acquisition of IPR&D



    674



    86,595

    Restructuring expense





    13,401

    Non-GAAP Net Income



    $                    68,641



    $                  112,164





















    Condensed Consolidated Balance Sheets



    December 31, 



    December 31, 

    (In thousands)



    2020



    2019

    Cash, cash equivalents and total investments



    $                  659,807



    $                  614,370

    Receivables



    275,143



    257,086

    Contract assets



    14,401



    8,386

    Inventory



    125,738



    101,803

    Prepaid expenses and other current assets



    60,662



    59,716

    Property, plant and equipment, net



    350,003



    362,168

    Intangible assets, net and goodwill



    204,064



    243,516

    Other assets



    259,912



    158,358

    Total Assets



    $               1,949,730



    $               1,805,403

    Long-term debt — current portion



    $                      2,843



    $                      2,843

    Other current liabilities



    435,415



    388,269

    Long-term debt   



    272,118



    274,295

    Contract liabilities — long-term 



    16,397



    22,068

    Other long-term liabilities



    155,975



    32,486

    Total shareholders' equity



    1,066,982



    1,085,442

    Total Liabilities and Shareholders' Equity



    $               1,949,730



    $               1,805,403











    Ordinary shares outstanding (in thousands)



    159,161



    157,779











    This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in

    Alkermes plc's Annual Report on Form 10-K for the year ended December 31, 2020, which the company intends to file in February 2021.

     

    Alkermes plc and Subsidiaries

    Revenues for Calendar Year 2020 and 2019



























    Three Months



    Three Months



    Three Months



    Three Months



    Year 





    Ended



    Ended



    Ended



    Ended



    Ended





    March 31,



    June 30,



    September 30,



    December 31,



    December 31,

    (In thousands)



    2020



    2020



    2020



    2020



    2020

    Revenues:





















    PARTNERED LONG-ACTING ANTIPSYCHOTICS (1)



    $                    82,243



    $                    83,114



    $      87,876



    $      92,327



    $     345,560

    VIVITROL



    78,769



    71,646



    80,258



    80,049



    310,722

    ARISTADA



    50,957



    58,769



    62,400



    68,912



    241,038

    Key Commercial Product Revenues



    211,969



    213,529



    230,534



    241,288



    897,320























    Legacy Product Revenues



    34,008



    33,391



    32,475



    38,566



    138,440

    License Revenue



     ` 



    1,050





    1,050

    Research and Development Revenues



    243



    609



    953



    141



    1,946

    Total Revenues



    $               246,220



    $               247,529



    $ 265,012



    $ 279,995



    $  1,038,756







































































    Three Months



    Three Months



    Three Months



    Three Months



    Year 





    Ended



    Ended



    Ended



    Ended



    Ended





    March 31,



    June 30,



    September 30,



    December 31,



    December 31,

    (In thousands)



    2019



    2019



    2019



    2019



    2019

    Revenues:





















    PARTNERED LONG-ACTING ANTIPSYCHOTICS (1)



    $                    75,605



    $                    91,863



    $      76,716



    $      79,147



    $     323,331

    VIVITROL



    69,183



    88,199



    85,164



    92,818



    335,364

    ARISTADA



    30,298



    48,436



    53,610



    56,791



    189,135

    Key Commercial Product Revenues



    175,086



    228,498



    215,490



    228,756



    847,830























    Legacy Product Revenues



    33,310



    36,034



    27,067



    28,140



    124,551

    License Revenue(2)





    1,000





    144,750



    145,750

    Research and Development Revenues



    14,706



    14,340



    12,686



    11,084



    52,816

    Total Revenues



    $               223,102



    $               279,872



    $ 255,243



    $ 412,730



    $  1,170,947























    (1) - Includes RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA.

    (2) - Includes a milestone payment received in the fourth quarter of 2019 which was allocated to the license sold to Biogen in connection with the VUMERITY collaboration.

     

    Alkermes plc and Subsidiaries

    2021 Guidance — GAAP to Non-GAAP Adjustments















    An itemized reconciliation between projected loss per share on a GAAP basis and projected earnings per share on a non-GAAP basis is as follows:















    (In millions, except per share data)



    Amount



    Shares



    (Loss)

    Earnings

    Per Share

    Projected Net Loss — GAAP



    $                    (105.0)



    160



    $        (0.66)

       Adjustments:













    Share-based compensation expense



    93.0









    Depreciation expense



    46.0









    Amortization expense



    40.0









    Income tax effect related to reconciling items 



    5.0









    Non-cash net interest expense



    1.0























    Projected Net Income — Non-GAAP



    $                        80.0



    161



    $          0.50















    Projected GAAP and non-GAAP measures reflect mid-points within ranges of estimated guidance.

     

    _________________________________________

    i
    The term "ARISTADA" as used in this press release refers to ARISTADA and ARISTADA INITIO®, unless the context indicates otherwise.

    ii CoREST: Co-repressor of repressor element-1 silencing transcription factor.

    iii Trivedi MH, Walker R, Ling W, et al. Bupropion and Naltrexone in Methamphetamine Use Disorder. New England Journal of Medicine, 2021;384:140-53. DOI: 10.1056/NEJMoa2020214.

    Alkermes Contacts:

    For Investors: Sandy Coombs      +1 781 609 6377

    For Media:      Katie Joyce   +1 781 249 8927

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  3. DUBLIN, Feb. 4, 2021 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) will host a conference call and webcast presentation at 8:00 a.m. ET (1:00 p.m. GMT) on Thursday, Feb. 11, 2021 to discuss the company's fourth quarter and year-end 2020 financial results. Management will also discuss financial expectations for 2021 and provide an update on the company.

    The webcast player and accompanying slides may be accessed on the Investors section of Alkermes' website at www.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.

    A replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. GMT) on Thursday, Feb. 11, 2021, through Thursday Feb. 18, 2021

    DUBLIN, Feb. 4, 2021 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) will host a conference call and webcast presentation at 8:00 a.m. ET (1:00 p.m. GMT) on Thursday, Feb. 11, 2021 to discuss the company's fourth quarter and year-end 2020 financial results. Management will also discuss financial expectations for 2021 and provide an update on the company.

    The webcast player and accompanying slides may be accessed on the Investors section of Alkermes' website at www.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.

    A replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. GMT) on Thursday, Feb. 11, 2021, through Thursday Feb. 18, 2021, and may be accessed by visiting Alkermes' website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay access code is 13715619. 

    About Alkermes plc

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    Alkermes Contact:

    Alex Braun

    Investor Relations

    +1 781 296 8493

     

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  4. DUBLIN, Jan. 14, 2021 /PRNewswire/ -- Results from a National Institute on Drug Abuse (NIDA)-funded study evaluating the efficacy and safety of naltrexone for extended-release injectable suspension (XR-NTX) administered once every three weeks plus oral extended-release bupropion administered daily as a combination treatment for adults with moderate or severe methamphetamine use disorder (MUD) were published today by Dr. Madhukar H. Trivedi et al. in the New England Journal of Medicine (NEJM).1 This is the second published study evaluating this combination regimen for the treatment of MUD.2 

    The number of adults living with MUD has risen in recent years. In 2019, approximately 1 million adults in the U.S. reported having a methamphetamine use…

    DUBLIN, Jan. 14, 2021 /PRNewswire/ -- Results from a National Institute on Drug Abuse (NIDA)-funded study evaluating the efficacy and safety of naltrexone for extended-release injectable suspension (XR-NTX) administered once every three weeks plus oral extended-release bupropion administered daily as a combination treatment for adults with moderate or severe methamphetamine use disorder (MUD) were published today by Dr. Madhukar H. Trivedi et al. in the New England Journal of Medicine (NEJM).1 This is the second published study evaluating this combination regimen for the treatment of MUD.2 

    The number of adults living with MUD has risen in recent years. In 2019, approximately 1 million adults in the U.S. reported having a methamphetamine use disorder—an increase of more than 50 percent since 2016.3 Currently, there are no FDA-approved medicines for the treatment of MUD. 

    "Given the scale and severity of the methamphetamine epidemic in the U.S., we applaud the clinical community's efforts and commitment to advancing research focused on treatment options for this critically underserved patient population," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "We're encouraged by the publication of this NIDA-funded study in the New England Journal of Medicine, and plan to engage with the FDA to better understand what options may exist for VIVITROL with regards to these data."

    VIVITROL® (naltrexone for extended-release injectable suspension) is not approved for the treatment of MUD. VIVITROL, developed by Alkermes (NASDAQ:ALKS), was approved by the U.S. Food and Drug Administration (FDA) for the treatment of alcohol dependence in 2006 and for the prevention of relapse to opioid dependence, following opioid detoxification, in 2010. VIVITROL is to be administered once every four weeks as part of a comprehensive management program that includes psychosocial support.

    About the ADAPT-2 Study

    The "Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder" study was a multi-site, double-blind, 12-week trial to evaluate the efficacy and safety of XR-NTX (380 mg every three weeks) plus oral extended-release bupropion (450 mg/day) in adults with moderate or severe MUD. Participants (N=403) with moderate or severe MUD (defined as reported use on at least 18 of the 30 days prior to randomization) were randomized to combination therapy (XR-NTX, 380 mg IM every three weeks, plus bupropion XL, up to 450 mg/d) versus placebo in a two-stage study. Placebo non-responders from stage 1 (6 weeks) were re-randomized in stage 2 for another 6 weeks. The primary outcome was the proportion of "responders," defined as having at least three methamphetamine-negative urine samples out of four samples obtained during weeks 5-6 (for stage 1) or weeks 11-12 (for stage 2). Response rates were higher with XR-NTX plus bupropion than with placebo across both stages (overall weighted treatment effect of 11.1 percentage points; Wald z-test statistic = 4.53; p < 0.001; NNT =9), as well as in each stage [stage 1: (16.5% COMB vs. 3.4% PBO); stage 2: (11.4% COMB vs. 1.8% PBO)]. Secondary outcomes also favored treatment with XR-NTX plus bupropion XL as compared to placebo. Adverse events in the combination treatment group included gastrointestinal disorders, tremor, malaise, hyperhidrosis, and anorexia. Serious adverse events occurred in 8 of 223 participants (3.6%) who received XR-NTX plus bupropion in the study. Alkermes provided XR-NTX and matched placebo free of charge for use in this trial under a written agreement with NIDA.

    About VIVITROL

    VIVITROL® (naltrexone for extended-release injectable suspension) is a once-monthly medication for the treatment of alcohol dependence and for the prevention of relapse to opioid dependence, following opioid detoxification. Treatment with VIVITROL should be part of a comprehensive management program that includes psychosocial support. For more information, visit www.vivitrol.com.

    About Alkermes

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders, and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    IMPORTANT SAFETY INFORMATION

    INDICATIONS

    VIVITROL is indicated for:

    • Treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. Patients should not be actively drinking at the time of initial VIVITROL administration.
    • Prevention of relapse to opioid dependence, following opioid detoxification.
    • VIVITROL should be part of a comprehensive management program that includes psychosocial support.

    CONTRAINDICATIONS

    VIVITROL is contraindicated in patients:

    • Receiving opioid analgesics
    • With current physiologic opioid dependence
    • In acute opioid withdrawal
    • Who have failed the naloxone challenge test or have a positive urine screen for opioids
    • Who have exhibited hypersensitivity to naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose, or any other components of the diluent

    IMPORTANT SAFETY INFORMATION

    WARNINGS AND PRECAUTIONS

    Vulnerability to Opioid Overdose:

    • After opioid detoxification, patients are likely to have a reduced tolerance to opioids. VIVITROL blocks the effects of exogenous opioids for approximately 28 days after administration. As the blockade wanes and eventually dissipates completely, use of previously tolerated doses of opioids could result in potentially life-threatening opioid intoxication (respiratory compromise or arrest, circulatory collapse, etc.).
    • Cases of opioid overdose with fatal outcomes have been reported in patients who used opioids at the end of a dosing interval, after missing a scheduled dose, or after discontinuing treatment. Patients and caregivers should be told of this increased sensitivity to opioids and the risk of overdose.
    • Although VIVITROL is a potent antagonist with a prolonged pharmacological effect, the blockade produced by VIVITROL is surmountable. The plasma concentration of exogenous opioids attained immediately following their acute administration may be sufficient to overcome the competitive receptor blockade. This poses a potential risk to individuals who attempt, on their own, to overcome the blockade by administering large amounts of exogenous opioids.
    • Any attempt by a patient to overcome the VIVITROL blockade by taking opioids may lead to fatal overdose. Patients should be told of the serious consequences of trying to overcome the opioid blockade.

    Injection Site Reactions:

    • VIVITROL must be prepared and administered by a healthcare provider.
    • VIVITROL injections may be followed by pain, tenderness, induration, swelling, erythema, bruising, or pruritus; however, in some cases injection site reactions may be very severe.
    • In the clinical trials, one patient developed an area of induration that continued to enlarge after 4 weeks, with subsequent development of necrotic tissue that required surgical excision.
    • Injection site reactions not improving may require prompt medical attention, including, in some cases, surgical intervention.
    • Inadvertent subcutaneous/adipose layer injection of VIVITROL may increase the likelihood of severe injection site reactions.
    • Select proper needle size for patient body habitus, and use only the needles provided in the carton.
    • Patients should be informed that any concerning injection site reactions should be brought to the attention of their healthcare provider.

    Precipitation of Opioid Withdrawal:

    • When withdrawal is precipitated abruptly by administration of an opioid antagonist to an opioid-dependent patient, the resulting withdrawal syndrome can be severe. Some cases of withdrawal symptoms have been severe enough to require hospitalization, and in some cases, management in the ICU.
    • To prevent occurrence of precipitated withdrawal, opioid-dependent patients, including those being treated for alcohol dependence, should be opioid-free (including tramadol) before starting VIVITROL treatment:
      • An opioid-free interval of a minimum of 7–10 days is recommended for patients previously dependent on short-acting opioids.
      • Patients transitioning from buprenorphine or methadone may be vulnerable to precipitated withdrawal for as long as two weeks.
    • If a more rapid transition from agonist to antagonist therapy is deemed necessary and appropriate by the healthcare provider, monitor the patient closely in an appropriate medical setting where precipitated withdrawal can be managed.
    • Patients should be made aware of the risk associated with precipitated withdrawal and be encouraged to give an accurate account of last opioid use.
    • Precipitated opioid withdrawal has been observed in alcohol-dependent patients in circumstances where the prescriber had been unaware of the additional use of opioids or co-dependence on opioids.

    Hepatotoxicity:

    • Cases of hepatitis and clinically significant liver dysfunction have been observed in association with VIVITROL. Warn patients of the risk of hepatic injury; advise them to seek help if experiencing symptoms of acute hepatitis. Discontinue use of VIVITROL in patients who exhibit acute hepatitis symptoms.

    Depression and Suicidality:

    • Alcohol- and opioid-dependent patients taking VIVITROL should be monitored for depression or suicidal thoughts. Alert families and caregivers to monitor and report the emergence of symptoms of depression or suicidality.

    When Reversal of VIVITROL Blockade Is Required for Pain Management:

    • For VIVITROL patients in emergency situations, suggestions for pain management include regional analgesia or use of non-opioid analgesics. If opioid therapy is required to reverse the VIVITROL blockade, patients should be closely monitored by trained personnel in a setting staffed and equipped for CPR.

    Eosinophilic Pneumonia:

    • Cases of eosinophilic pneumonia requiring hospitalization have been reported. Warn patients of the risk of eosinophilic pneumonia and to seek medical attention if they develop symptoms of pneumonia.

    Hypersensitivity Reactions including Anaphylaxis:

    • Cases of urticaria, angioedema, and anaphylaxis have been observed with use of VIVITROL in the clinical trial setting and in postmarketing use.
    • Patients should be warned of the risk of hypersensitivity reactions, including anaphylaxis.
    • In the event of a hypersensitivity reaction, patients should be advised to seek immediate medical attention in a healthcare setting prepared to treat anaphylaxis. The patient should not receive any further treatment with VIVITROL.

    Intramuscular Injections:

    • As with any intramuscular injection, VIVITROL should be administered with caution to patients with thrombocytopenia or any coagulation disorder.

    Alcohol Withdrawal:

    • Use of VIVITROL does not eliminate nor diminish alcohol withdrawal symptoms.

    Interference with Laboratory Tests

    • VIVITROL may be cross-reactive with certain immunoassay methods for the detection of drugs of abuse (specifically opioids) in urine.
    • For further information, reference to the specific immunoassay instructions is recommended.

    ADVERSE REACTIONS

    • The adverse events seen most frequently in association with VIVITROL therapy for alcohol dependence (ie, those occurring in ≥5% and at least twice as frequently with VIVITROL than placebo) include nausea, vomiting, injection site reactions (including induration, pruritus, nodules, and swelling), arthralgia, arthritis, or joint stiffness, muscle cramps, dizziness or syncope, somnolence or sedation, anorexia, decreased appetite or other appetite disorders.
    • The adverse events seen most frequently in association with VIVITROL in opioid-dependent patients (ie, those occurring in ≥2% and at least twice as frequently with VIVITROL than placebo) were hepatic enzyme abnormalities, injection site pain, nasopharyngitis, insomnia, and toothache.

    You are encouraged to report side effects to the FDA.

    Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

    Note Regarding Forward-Looking Statements

    Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the potential therapeutic and commercial value of XR-NTX plus bupropion as a combination treatment for MUD; and the company's plans to engage with the FDA regarding potential options for VIVITROL relating to the ADAPT-2 data. You are cautioned that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others, whether the combination treatment of XR-NTX plus bupropion could be shown to be unsafe or ineffective; whether clinical results for this combination treatment will be predictive of results of future clinical studies or real-world results; the outcome of interactions with the FDA related to VIVITROL and the ADAPT-2 data; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2019, the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

    VIVITROL® is a registered trademark of Alkermes, Inc.

     

    1 Trivedi MH, Walker R, Ling, W, et al. Bupropion and Naltrexone in Methamphetamine Use Disorder. New England Journal of Medicine, 2021;384:140-53. DOI: 10.1056/NEJMoa2020214

    2 Mooney LJ, Hillhouse MP, Thomas C, et al. Utilizing a Two-stage Design to Investigate the Safety and Potential Efficacy of Monthly Naltrexone Plus Once-daily Bupropion as a Treatment for Methamphetamine Use Disorder. Journal of Addiction Medicine, 2016;10(4), 236–243. https://doi.org/10.1097/ADM.0000000000000218 

    3 SAMHSA. Behavioral Health Trends in the United States: Results from the 2016 and 2019 National Surveys on Drug Use and Health. Accessed on Jan. 12, 2021 from: https://www.samhsa.gov/data/data-we-collect/nsduh-national-survey-drug-use-and-health.

     

    Alkermes Contacts:

    For Investors: Sandy Coombs, +1 781 609 6377

    For Media: Marisa Borgasano, +1 781 609 6659

     

    Alkermes plc Logo (PRNewsfoto/Alkermes plc)

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  5. DUBLIN, Jan. 6, 2021 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) announced today that its Chief Executive Officer, Richard Pops, will provide a corporate overview and update at the 39th Annual J.P. Morgan Healthcare Conference. The presentation will take place virtually on Wednesday, Jan. 13, 2021 at 10:00 a.m. EST (3:00 p.m. GMT), followed by a question and answer session. 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 is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia…

    DUBLIN, Jan. 6, 2021 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) announced today that its Chief Executive Officer, Richard Pops, will provide a corporate overview and update at the 39th Annual J.P. Morgan Healthcare Conference. The presentation will take place virtually on Wednesday, Jan. 13, 2021 at 10:00 a.m. EST (3:00 p.m. GMT), followed by a question and answer session. 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 is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    Contact:

    Alex Braun

    Investor Relations

    +1 781 296 8493

    Alkermes plc Logo (PRNewsfoto/Alkermes plc)

     

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  6. DUBLIN, Jan. 6, 2021 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS), a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology, today announced a series of changes to its executive leadership team. Blair C. Jackson has been appointed chief operating officer (COO) and Iain M. Brown will assume the role of chief financial officer (CFO), replacing James M. Frates. Mr. Frates will leave the company following a 20-year career at Alkermes to pursue another opportunity.  

    "Alkermes is focused on executing on our business strategy, including the implementation of our recently-announced Value Enhancement Plan. I am pleased to have Blair and Iain assume these key leadership roles at this…

    DUBLIN, Jan. 6, 2021 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS), a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology, today announced a series of changes to its executive leadership team. Blair C. Jackson has been appointed chief operating officer (COO) and Iain M. Brown will assume the role of chief financial officer (CFO), replacing James M. Frates. Mr. Frates will leave the company following a 20-year career at Alkermes to pursue another opportunity.  

    "Alkermes is focused on executing on our business strategy, including the implementation of our recently-announced Value Enhancement Plan. I am pleased to have Blair and Iain assume these key leadership roles at this pivotal time as we position the company for our next stage of growth and advance our commitment to delivering value to all of our stakeholders," said Richard Pops, chairman and chief executive officer of Alkermes. "On behalf of the entire Alkermes team, I want to thank Jim for his countless contributions to the organization. Jim's dedication and commitment to Alkermes and the disease areas we serve has been an inspiration to us all. We are grateful for his leadership during his tenure and wish him the best in his future endeavors."

    Mr. Jackson will expand his current role as senior vice president of corporate planning to become executive vice president and COO, a newly created role which will oversee global operations, quality, finance, information technology, and corporate planning. Mr. Jackson has more than 20 years of experience in the biopharmaceutical industry and has served in various positions in both a scientific and corporate capacity at Alkermes. Mr. Jackson received a Bachelor of Arts degree in Biochemistry from the University of Calgary, a Bachelor of Arts in Chemical Engineering and a Master of Business Administration from the University of Alberta, and a Master of Science in Chemical Engineering from the Massachusetts Institute of Technology.

    Mr. Brown, currently senior vice president and chief accounting officer, will assume full responsibility for the finance organization in his new role as CFO with additional oversight of the business planning, procurement and strategic sourcing functions. Mr. Brown is a highly-accomplished finance professional and Chartered Accountant with more than 24 years of experience in the biopharmaceutical industry, with a strong track record in operational finance and financial compliance. Mr. Brown received a Bachelor of Science degree in Business Studies from the University of Bradford, England. 

    "It has been a great privilege to be part of the Alkermes team and I am incredibly proud of all that the organization has accomplished," said Mr. Frates. "I depart with confidence knowing that the organization is strong and well positioned to support its fundamental mission of making a meaningful difference in the lives of people living with serious mental illness, addiction and cancer."

    About Alkermes

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    Note Regarding Forward-Looking Statements

    Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company's expectations concerning future financial and operating performance, business plans or prospects, including the company's ability to execute on its business strategy, position itself for growth and deliver value to its stakeholders; and the potential therapeutic and commercial value of the company's marketed and development products focused on serious mental illness, addiction and cancer. The company cautions that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: the cost structure review and optimization activities being undertaken by the company may not yield the intended results; the company may not be able to achieve its targeted financial metrics, profitability or long-term value creation in a timely manner or at all; the unfavorable outcome of litigation, including so-called "Paragraph IV" litigation and other patent litigation, related to any of the company's products or products using the company's proprietary technologies, which may lead to competition from generic drug manufacturers; clinical development activities may not be completed on time or at all; the results of the company's clinical development activities may not be positive, or predictive of real-world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products, such as decisions not to approve the company's NDAs, including the NDA for ALKS 3831; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; the impacts of the ongoing COVID-19 pandemic and continued efforts to mitigate its spread on the company's business, results of operations or financial condition; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2019, the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission ("SEC"), which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

    Alkermes Contacts:





    For Investors: 

    Sandy Coombs

    +1 781 609 6377

    For Media:     

    Katie Joyce

    +1 781 609 6806

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  7. DUBLIN, Dec. 29, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the company's New Drug Application (NDA) resubmission for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder, and has assigned the application a new Prescription Drug User Fee Act (PDUFA) target action date of June 1, 2021.

    The FDA classified the resubmission as a complete, Class 2 response to the Complete Response Letter (CRL) issued in November 2020, following a remote review of records requested under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (the "FDCA") relating to the manufacture of ALKS 3831 at…

    DUBLIN, Dec. 29, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the company's New Drug Application (NDA) resubmission for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder, and has assigned the application a new Prescription Drug User Fee Act (PDUFA) target action date of June 1, 2021.

    The FDA classified the resubmission as a complete, Class 2 response to the Complete Response Letter (CRL) issued in November 2020, following a remote review of records requested under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (the "FDCA") relating to the manufacture of ALKS 3831 at the company's Wilmington, OH facility. Subsequent to Alkermes' resubmission of the NDA, the FDA issued a new request for records under Section 704(a)(4) of the FDCA to supplement the information previously provided by the company. Neither the CRL nor this subsequent records request identified or raised any concerns about the clinical or non-clinical data in the NDA and the FDA has not asked Alkermes to complete any new clinical trials to support approval of the application.

    Alkermes will continue to work closely with the FDA as it completes its review of the ALKS 3831 NDA and remains committed to making ALKS 3831 available to patients as quickly as possible.

    About Schizophrenia 

    Schizophrenia is a serious brain disorder marked by positive symptoms (hallucinations and delusions, disorganized speech and thoughts, and agitated or repeated movements) and negative symptoms (depression, blunted emotions and social withdrawal).1 An estimated 2.4 million American adults have schizophrenia,2 with men and women affected equally.

    About Bipolar I Disorder

    Bipolar disorder is a brain disorder that causes shifts in a person's mood, energy and ability to function. Individuals with this brain disorder may experience debilitating mood shifts from extreme highs (mania) to extreme lows (depression). Bipolar I disorder is characterized by the occurrence of at least one manic episode, with or without the occurrence of a major depressive episode, and affects approximately one percent of the adult population in the United States in any given year.3

    About ALKS 3831 (olanzapine/samidorphan)

    ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. ALKS 3831 is composed of samidorphan, a novel, new molecular entity, co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.

    About Alkermes plc

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    Note Regarding Forward-Looking Statements

    Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the potential therapeutic and commercial value of ALKS 3831 for the treatment of adults with schizophrenia and the treatment of adults with bipolar I disorder; the company's expectations regarding next steps for the NDA for ALKS 3831, including the FDA's PDUFA target action date for the NDA and the company's plans to work with the FDA as it completes its review of the NDA; and the company's commitment to making ALKS 3831 available to patients as quickly as possible. The company cautions that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: whether data from the company's manufacturing processes may be interpreted by the FDA in different ways than the company interprets it; potential changes in the cost, scope and duration of the ALKS 3831 development and regulatory program following receipt of the FDA's CRL and subsequent records request; whether the FDA will approve the NDA for ALKS 3831 in a timely manner or at all; if approved, whether the FDA will impose conditions on the marketing of ALKS 3831, such as a risk evaluation and mitigation strategy; whether future clinical trials for ALKS 3831, if any, will be completed on time or at all; unanticipated impacts of the COVID-19 pandemic on the operations of the company and on the operations of the regulatory agencies involved in the review and potential approval of ALKS 3831; whether ALKS 3831 could be shown ineffective or unsafe during clinical studies; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2019, the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission ("SEC"), which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

    1American Psychiatric Association. Schizophrenia Spectrum and Other Psychiatric Disorders. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Washington, DC: American Psychiatric Publishing; 2013.

    National Institutes of Health. Schizophrenia. Accessed on Dec. 28, 2020 from https://archives.nih.gov/asites/report/09-09-2019/report.nih.gov/nihfactsheets/Pdfs/Schizophrenia(NIMH).pdf.

    Merikangas et al. Lifetime and 12-Month Prevalence of Bipolar Spectrum Disorder in the National Comorbidity Survey Replication. Arch Gen Psychiatry, 2007 May; 64(5): 543-552.  http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1931566/ 

    Alkermes Contacts:

    For Investors:

    Sandy Coombs

    +1 781 609 6377

    For Media:

    Marisa Borgasano

    +1 781 609 6659

     

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  8. DUBLIN, Dec. 10, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced a Value Enhancement Plan, or the Plan, designed to drive growth, improve operational and financial performance and enhance shareholder value, as the company continues to advance its mission of developing new medicines designed to have a real-world impact in the treatment of serious mental illness, addiction and cancer. The Plan includes a commitment to multi-year profitability targets, a review and optimization of the company's cost structure, potential monetization of non-core assets, and continued governance enhancements, including the addition of two new independent directors with substantial financial and operational expertise to the company's board of directors…

    DUBLIN, Dec. 10, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced a Value Enhancement Plan, or the Plan, designed to drive growth, improve operational and financial performance and enhance shareholder value, as the company continues to advance its mission of developing new medicines designed to have a real-world impact in the treatment of serious mental illness, addiction and cancer. The Plan includes a commitment to multi-year profitability targets, a review and optimization of the company's cost structure, potential monetization of non-core assets, and continued governance enhancements, including the addition of two new independent directors with substantial financial and operational expertise to the company's board of directors (the "Board").

    The Value Enhancement Plan is the result of an intensive process initiated over the last several months and is intended to position the company to efficiently execute on its business strategy, support the continued growth of its commercial products, including the potential approval and launch of ALKS 3831, and further the advancement of its pipeline of development programs. The Plan builds upon the company's implementation of a restructuring and addition of two new independent directors to the Board in the fall of 2019 and the company's board refreshment efforts announced in July 2020. These initiatives also follow constructive dialogue with the company's shareholders, including funds advised by Elliott Advisors (UK) Limited ("Elliott"), and entry into an associated cooperation agreement between Alkermes and affiliates of Elliott.

    "Alkermes' Board and management are committed to engaging with shareholders and understanding their perspective and have been working on initiatives to drive greater operational efficiency, with a focus on shareholder value creation. These new initiatives also support our strong growth trajectory, which has come more clearly into focus over the past few months, with the positive advisory committee meeting and constructive regulatory interactions for ALKS 3831 for schizophrenia and bipolar I disorder, and with new clinical data emerging in our ALKS 4230 immuno-oncology program," said Richard Pops, Chairman and Chief Executive Officer of Alkermes. "We believe these actions, alongside our focus on commercial execution, the potential approval and commercial launch of ALKS 3831, and the continued development of our pipeline candidates, position the company well for long-term value creation."

    A spokesperson for Elliott said, "Elliott is highly supportive of the initiatives announced today and commends the Board and management of Alkermes on taking these steps. From our dialogue with management we are confident that the Company is committed to creating shareholder value. Further, both David Daglio and Brian McKeon will add significant value to Alkermes' Board and the newly formed board committee. Alkermes is significantly undervalued given its attractive assets and growth potential, and we are confident that these new initiatives will yield meaningful share price upside. We thank Richard and the rest of the team for their constructive dialogue and look forward to an ongoing engagement with the Company."

    Profitability Targets & Cost Structure Optimization Efforts

    As part of the Value Enhancement Plan, the company today announced its commitment to achieving:

    • FY 2023 non-GAAP net income equal to 25% of the company's total revenues and EBITDA margin1 of 20% of total revenues
    • FY 2024 non-GAAP net income equal to 30% of the company's total revenues and EBITDA margin of 25% of total revenues

    The company plans to achieve these margins through disciplined management of the company's cost structure combined with revenue growth, and is committed to meeting these targets in a range of scenarios. To underline Alkermes' commitment to strong profitability, the compensation committee of the Board will consider these targets in its design of this year's long-term incentive plan for senior management.

    Alkermes has already undertaken several important initiatives to support these targets, including a reorganization of the company's commercial infrastructure, which was implemented in November 2020. As part of the reorganization, several functional areas within the company's commercial organization were consolidated to improve efficiencies and approximately 80 full-time positions were reallocated to support the anticipated launch of ALKS 3831, reducing the need for previously planned new hires. Additionally, the company has commenced an extensive review of its operations and structure both internally and with external advisors to identify potential areas for improved efficiencies. This review is ongoing, and the company plans to provide an update on the findings and planned initiatives resulting from the review following its conclusion, expected in the first quarter of 2021.

    Evaluation of Strategic Opportunities

    A newly set-up committee of the board will evaluate a broad range of potential strategic options related to Alkermes' non-core assets, including monetization and divestiture opportunities.

    In addition, the company underscored its prior commitment to exploring a strategic collaboration for ALKS 4230, the company's immuno-oncology pipeline candidate, as an important element of the company's focus on realizing the full potential of ALKS 4230 across a broad spectrum of possible treatment combinations, tumor types and lines of therapy. Alkermes believes that accumulating objective response data and subcutaneous administration data from its ARTISTRY development program for ALKS 4230 will serve as the basis for potential collaboration discussions.     

    Board Refreshment and Governance Update

    The company today announced that it is taking a series of actions as part of its ongoing commitment to strong corporate governance and regular Board refreshment. These efforts build upon the refreshment process that began in 2019 with the engagement of a leading recruitment firm and the subsequent appointment of two highly-qualified independent directors: Andy Wilson and Richard Gaynor, M.D. 

    • Following the company's July 2020 announcement of its continuing Board refreshment efforts, the Alkermes Board has appointed two new independent directors – David Daglio and Brian McKeon – who bring investor perspectives and strong financial and operational expertise to the Board.
    • Two long-serving directors, Robert Breyer and Paul Mitchell, plan to retire and step down from the Board at the close of the company's 2021 Annual General Meeting of Shareholders.
    • The Board plans to identify at least one additional independent director to be appointed in the first half of 2021.

    "Our board refreshment efforts during the past two years reflect our continued commitment to a strong, independent board with expertise that aligns with and directly supports Alkermes' strategic priorities," said Lead Independent Director David W. Anstice. "I am pleased to welcome David and Brian to the Board and believe that Alkermes will benefit greatly from their distinct combination of financial and operational expertise. We are confident that the Board is well positioned to provide robust guidance and oversight as the company continues its efforts to positively impact the lives of patients living with serious mental illness, addiction and cancer, while driving shareholder value creation."

    "On behalf of the Board, I would also like to express our most sincere appreciation to Paul Mitchell and Bob Breyer for their long and distinguished tenure on the Board and their invaluable contributions to Alkermes," Mr. Anstice added.

    In addition to the appointment of new directors, the company will also undertake the following corporate governance actions:

    • The Board plans to form a committee to oversee achievement of the Profitability Targets and the potential monetization of the company's non-core assets. The committee will initially be comprised of the Chief Executive Officer and three independent directors, including two of the newly appointed directors.
    • The Board also intends to recommend that the company's shareholders approve, at the company's 2021 Annual General Meeting of Shareholders, an amendment to the company's Articles of Association to declassify the Board.

    Investor Day

    The company plans to host an investor day in the first quarter of 2021 to provide an update on the implementation of the Value Enhancement Plan and highlight some of the new research and development programs in the company's portfolio.

    New Director Biographies

    About David Daglio

    As former Executive Vice President and Chief Investment Officer of Mellon Investments, Mr. Daglio brings a seasoned institutional investment management perspective to the Board. Over his 21-year career at Mellon, Mr. Daglio oversaw active equity portfolio management teams, served as the head of Opportunistic Value strategies and on Mellon's board of directors, and helped architect and manage the merger of three unique companies to create the 12th largest U.S. asset manager. In his roles at Mellon, Mr. Daglio worked with institutional clients and boards around the world and grew portfolio assets by more than five-fold. Mr. Daglio currently serves as a director of Total Brain Ltd.

    About Brian McKeon

    Mr. McKeon brings strong financial and management expertise as well as public company executive and director experience to the Board. He has served as Executive Vice President and Chief Financial Officer of IDEXX Laboratories since 2014, leading its finance, corporate development and strategy, and investor relations functions, and, since June 2019, has overseen IDEXX's livestock, water and human diagnostics businesses. Mr. McKeon previously served as a director of IDEXX from 2003 through 2013, and as a director of athenahealth, Inc. from September 2017 to February 2019. Prior to IDEXX, Mr. McKeon held executive leadership roles at Iron Mountain, The Timberland Company and PepsiCo.

    About Alkermes

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    About Elliott

    Elliott Management Corporation manages approximately $41 billion of assets. Its flagship fund, Elliott Associates, L.P., was founded in 1977, making it one of the oldest funds of its kind under continuous management. The Elliott funds' investors include pension plans, sovereign wealth funds, endowments, foundations, funds-of-funds, and employees of the firm. Elliott Advisors (UK) Limited is an affiliate of Elliott Management Corporation.

    Non-GAAP Financial Measures

    Non-GAAP net income (loss) adjusts for one-time and non-cash charges by excluding from U.S. generally accepted accounting principles ("GAAP") results: share-based compensation expense; amortization; depreciation; non-cash net interest expense; changes in the fair value of the contingent consideration; certain other one-time or non-cash items; and the income tax effect of these reconciling items.

    Note Regarding Forward-Looking Statements

    Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company's expectations concerning future financial and operating performance, business plans or prospects, including expected revenue growth, the company's commitment to, and ability to achieve, specified profitability targets, including non-GAAP net income and EBITDA margin targets as a percentage of total revenues, oversight of the achievement of such targets by a newly formed Board committee, and the company's ability to create share price upside and long-term value for shareholders through expense management, cost structure optimization and potential monetization or divestiture of non-core assets; the company's expectations regarding the timing and results of the review of the company's operations and cost structure; the potential therapeutic and commercial value of the company's marketed and development products; the company's expectations concerning future development activities for the company's development products, including expectations regarding the potential for future ALKS 4230 data to serve as a basis for a potential collaboration; expectations concerning the company's regulatory interactions and commercial activities, including those relating to the potential approval and commercial launch of ALKS 3831; and the company's plans for additional Board-related changes, including the expected appointment of at least one additional director and its plans to recommend declassification of the Board. The company cautions that forward-looking statements are inherently uncertain. The forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: the cost structure review and optimization activities being undertaken by the company may not yield the intended results; the company may not be able to achieve its targeted profitability metrics, including non-GAAP net income and EBITDA margin targets as a percentage of total revenues, in a timely manner or at all; the unfavorable outcome of litigation, including so-called "Paragraph IV" litigation and other patent litigation, related to any of the company's products or products using the company's proprietary technologies, which may lead to competition from generic drug manufacturers; clinical development activities may not be completed on time or at all; the results of the company's clinical development activities may not be positive, or predictive of real-world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products, such as decisions not to approve the company's NDAs, including the NDA for ALKS 3831; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and the impacts of the ongoing COVID-19 pandemic and continued efforts to mitigate its spread on the company's business, results of operations or financial condition; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2019, the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission ("SEC"), which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

    Alkermes Contacts:



    For Investors:

    Sandy Coombs +1 781 609 6377

    For Media:

    Katie Joyce +1 781 609 6806

     

    Alkermes plc Logo (PRNewsfoto/Alkermes plc)

    1Calculated as earnings before interest, taxation, depreciation, amortization and one-time items, includes share-based compensation expenses

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  9. DUBLIN, Nov. 17, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder. Following a remote review of manufacturing records, FDA stated that resolution of certain conditions related to the tablet coating process at the company's Wilmington, OH facility is required before ALKS 3831 may be approved. The CRL did not identify or raise any concerns about the clinical or non-clinical data in the NDA and the FDA has not asked Alkermes to complete any new clinical trials to support approval…

    DUBLIN, Nov. 17, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder. Following a remote review of manufacturing records, FDA stated that resolution of certain conditions related to the tablet coating process at the company's Wilmington, OH facility is required before ALKS 3831 may be approved. The CRL did not identify or raise any concerns about the clinical or non-clinical data in the NDA and the FDA has not asked Alkermes to complete any new clinical trials to support approval of the application.

    The observations noted in the CRL were specific to certain development batches of ALKS 3831. The company believes this issue has since been resolved and that sufficient data is available to address these observations. Alkermes is preparing those data for submission and plans to work closely with the Agency to resolve these items in a timely manner and complete labeling discussions for the application.

    Consistent with FDA's August 2020 Guidance for Industry related to manufacturing inspections during the COVID-19 global pandemic, the Agency did not conduct an on-site Pre-Approval Inspection (PAI) at the company's Wilmington, OH manufacturing facility during its review of the NDA, and instead conducted a remote review of records under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act. FDA confirmed receipt of the requested records provided by Alkermes on Sept. 11, 2020 and, since that date, no report or feedback from this records review was provided to Alkermes until receipt of the CRL.

    "We will continue to work closely with the Agency in an expeditious manner to support approval of ALKS 3831 for the treatment of schizophrenia and bipolar I disorder and believe we have a clear path to resolution. Importantly, there were no clinical issues identified in the CRL pertaining to ALKS 3831's efficacy or safety, and no new studies were requested for approval of the application," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes.

    The NDA submission for ALKS 3831 was based on data from 27 clinical studies, including 18 studies evaluating ALKS 3831 and nine studies evaluating samidorphan alone, and pharmacokinetic bridging data comparing ALKS 3831 and ZYPREXA®. Throughout the clinical development program, ALKS 3831 demonstrated a consistent antipsychotic efficacy, safety, and tolerability profile in patients with schizophrenia.

    In October 2020, the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee appointed by the FDA jointly voted that samidorphan meaningfully mitigates olanzapine-associated weight gain (16 yes, 1 no) and that the safety profile of ALKS 3831 has been adequately characterized (13 yes, 3 no, 1 abstention). The committees also jointly voted that labeling is sufficient to mitigate the risks related to the opioid antagonist action of samidorphan (11 yes, 6 no).

    Conference Call

    Alkermes will host a conference call for analysts and investors on Tuesday, Nov. 17, 2020, at 8:00 a.m. ET (1:00 p.m. GMT). The webcast player may be accessed on the Investors section of Alkermes' website at www.alkermes.com. To participate in the question and answer session, please dial in to the conference call, which 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 or by dialing +1 877-660-6853 for U.S. callers and +1 201-612-7415 for international callers, using replay access code 13713465. The conference call replay will be available from 11:00 a.m. ET (4:00 p.m. GMT) on Tuesday, Nov. 17, 2020 through Tuesday, Nov. 24, 2020.

    About Schizophrenia 

    Schizophrenia is a serious brain disorder marked by positive symptoms (hallucinations and delusions, disorganized speech and thoughts, and agitated or repeated movements) and negative symptoms (depression, blunted emotions and social withdrawal).1 An estimated 2.4 million American adults have schizophrenia,2 with men and women affected equally.

    About Bipolar I Disorder

    Bipolar disorder is a brain disorder that causes shifts in a person's mood, energy and ability to function. Individuals with this brain disorder may experience debilitating mood shifts from extreme highs (mania) to extreme lows (depression). Bipolar I disorder is characterized by the occurrence of at least one manic episode, with or without the occurrence of a major depressive episode, and affects approximately one percent of the adult population in the United States in any given year.3

    About ALKS 3831 (olanzapine/samidorphan)

    ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. ALKS 3831 is composed of samidorphan, a novel, new molecular entity, co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.

    About Alkermes plc

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    Note Regarding Forward-Looking Statements

    Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the potential therapeutic and commercial value of ALKS 3831 for the treatment of adults with schizophrenia and the treatment of adults with bipolar I disorder; the company's expectations regarding next steps for the NDA for ALKS 3831, including its plans to engage with the FDA to resolve any outstanding FDA requests; and the company's belief in its ability to expeditiously complete labeling discussions with the FDA and resolve any outstanding items required by the FDA to support approval of the NDA for ALKS 3831. The company cautions that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: whether the company will be able to sufficiently resolve all FDA requests to meet the FDA's requirements for approval in a timely manner or at all; whether data from the company's manufacturing processes may be interpreted by the FDA in different ways than the company interprets it; potential changes in the cost, scope and duration of the ALKS 3831 development and regulatory program following receipt of the FDA's CRL; whether the FDA will approve the NDA for ALKS 3831 in a timely manner or at all; if approved, whether the FDA will impose conditions on the marketing of ALKS 3831, such as a risk evaluation and mitigation strategy; whether future clinical trials for ALKS 3831, if any, will be completed on time or at all; unanticipated impacts of the COVID-19 pandemic on the operations of the company and on the operations of the regulatory agencies involved in the review and potential approval of ALKS 3831; whether ALKS 3831 could be shown ineffective or unsafe during clinical studies; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2019, the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission ("SEC"), which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

    ZYPREXA® is a registered trademark of Eli Lilly & Company.

    1American Psychiatric Association. Schizophrenia Spectrum and Other Psychiatric Disorders. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Washington, DC: American Psychiatric Publishing; 2013.

    National Institutes of Health. Schizophrenia. Accessed on Nov. 16, 2020 from https://archives.nih.gov/asites/report/09-09-2019/report.nih.gov/nihfactsheets/Pdfs/Schizophrenia(NIMH).pdf.

    Merikangas et al. Lifetime and 12-Month Prevalence of Bipolar Spectrum Disorder in the National Comorbidity Survey Replication. Arch Gen Psychiatry, 2007 May; 64(5): 543-552. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1931566/ 

    Alkermes Contacts:

    For Investors:

    Sandy Coombs,   

    +1 781 609 6377

    For Media:     

    Eva Stroynowski,

    +1 781 609 6823

     

    Alkermes plc Logo (PRNewsfoto/Alkermes plc)

     

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  10. DUBLIN, Nov. 9, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced the presentation of new data from the ARTISTRY clinical development program for ALKS 4230, Alkermes' investigational engineered interleukin-2 (IL-2) variant immunotherapy, at the Society for Immunotherapy of Cancer's (SITC) 35th Anniversary Annual Meeting, being held virtually Nov. 11-14, 2020. The company will present preliminary safety, tolerability and pharmacokinetic/pharmacodynamic data from the dose-escalation stage of ARTISTRY-2, the ongoing phase 1/2 study evaluating ALKS 4230 administered subcutaneously (SC) either once-weekly or once-every-three-weeks. A detailed analysis of clinical responses observed in ovarian cancer patients and other new updates from…

    DUBLIN, Nov. 9, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced the presentation of new data from the ARTISTRY clinical development program for ALKS 4230, Alkermes' investigational engineered interleukin-2 (IL-2) variant immunotherapy, at the Society for Immunotherapy of Cancer's (SITC) 35th Anniversary Annual Meeting, being held virtually Nov. 11-14, 2020. The company will present preliminary safety, tolerability and pharmacokinetic/pharmacodynamic data from the dose-escalation stage of ARTISTRY-2, the ongoing phase 1/2 study evaluating ALKS 4230 administered subcutaneously (SC) either once-weekly or once-every-three-weeks. A detailed analysis of clinical responses observed in ovarian cancer patients and other new updates from ARTISTRY-1, the ongoing phase 1/2 study investigating ALKS 4230 administered intravenously (IV), will also be presented. Both studies are evaluating ALKS 4230 as a monotherapy and in combination with the PD-1 inhibitor pembrolizumab (KEYTRUDA®) in patients with heavily pretreated advanced solid tumors.

    "Accumulating evidence across the ARTISTRY clinical program provides insight into ALKS 4230's potential as a novel treatment option, both as monotherapy in melanoma and in combination with pembrolizumab, for a number of tumor types that do not typically respond to current standards of care. The responses observed with the combination regimen in platinum-resistant ovarian cancer, triple negative breast cancer, and recently in cervical cancer, are encouraging signs of ALKS 4230's potential utility in these cancers," said Ira Winer, M.D., Ph.D., Associate Professor, Division of Gynecologic Oncology, Wayne State University and Karmanos Cancer Institute.  "In addition, the data presented at SITC from ARTISTRY-2 in patients with advanced solid tumors showed a safety profile and immune response comparable to ALKS 4230 administered intravenously, indicating that ALKS 4230 may offer an alternate subcutaneous dosing option for patients."

    "The ALKS 4230 subcutaneous dose-escalation data in heavily pretreated patients with certain solid tumors demonstrated expansion of tumor-killing CD8+ T cells and NK cells consistent with the expansion observed with intravenous dosing of ALKS 4230. These data support the potential for once-weekly or once-every-three-week subcutaneous dosing of ALKS 4230, for which we expect to identify our recommended phase 2 dose by year-end," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "Further, based on the durable complete and partial responses observed in the ARTISTRY-1 intravenous dosing study in tumor types with high unmet need and limited treatment options for patients, we are considering potential regulatory strategies that may support expeditious development paths in both monotherapy and combination settings."

    The two posters are available on the SITC website at https://sitc.sitcancer.org/2020/abstracts/titles/. Highlights from the poster presentations, which reflect data as of Sept. 29, 2020 unless otherwise noted, include:

    Poster #671: Phase 1/2 Study of Subcutaneously Administered ALKS 4230, a Novel Engineered Cytokine, as Monotherapy and in Combination With Pembrolizumab, in Patients With Advanced Solid Tumors: ARTISTRY-2

    The ongoing dose-escalation stage of ARTISTRY-2 is evaluating the safety and tolerability of ascending doses of SC ALKS 4230 administered either once-weekly (Q7) or once-every-three-weeks (Q21) as lead-in monotherapy for six weeks, followed by combination with pembrolizumab. The pharmacokinetic/pharmacodynamic (PK/PD) data presented include seven dose-escalation cohorts of SC ALKS 4230 (Q7: 0.3, 0.6, 1, 3 mg; Q21: 1, 3, 10 mg):

    • ALKS 4230 was assessed in 43 heavily pretreated patients with refractory solid tumors. Of these, 30 patients completed the monotherapy lead-in portion of the study and initiated combination treatment with pembrolizumab.
    • Treatment with SC ALKS 4230 resulted in a dose-dependent increase in circulating natural killer (NK) cells and CD8+ T cells, with an approximately 16-fold and 3-fold expansion, respectively, at the 3 mg Q7 dose. At the 10 mg Q21 dose there was an approximately 6-fold and 3-fold expansion in NK cells and CD8+ T cells, respectively. There was a minimal, non-dose-dependent change in regulatory T (Treg) cells.
      • The NK and CD8+ T cell expansions observed for the 3 mg Q7 and 10 mg Q21 SC doses were equivalent or greater compared to the expansions observed in ARTISTRY-1 at the 3 µg/kg/day and 6 µg/kg/day IV doses of ALKS 4230, respectively.  
      • Compared to the 6 µg/kg/day IV dose, the recommended phase 2 dose (RP2D) identified for ARTISTRY-1, the 3 mg and 10 mg doses of SC ALKS 4230 induced higher levels of interferon gamma, a cytokine that has been associated with antitumor efficacy in clinical studies.1 Relative to IV ALKS 4230, SC ALKS 4230 induced a lower, transient upregulation of IL-6 concentrations.
      • ALKS 4230 at the SC doses studied showed a safety and tolerability profile consistent with the anticipated pharmacologic effects and what has been observed with IV ALKS 4230. The most commonly reported adverse events (AEs) across the ARTISTRY-2 study were injection site reactions, fever, chills, fatigue, nausea and lymphopenia. One patient experienced dose-limiting AEs at the 10 mg Q21 dose (grade 3 nausea, vomiting, and fatigue). Following a dose reduction, the patient continued on study.
    • Preliminary clinical benefit was observed, even in immunotherapy-pretreated patients. As of the data cutoff date, 11 patients had continued on therapy for more than 6 months.
    • The maximum tolerated dose and the RP2D for SC ALKS 4230 have not yet been determined.

    Poster #689: Clinical Outcomes of Ovarian Cancer Patients Treated With ALKS 4230, a Novel Engineered Cytokine, in Combination With Pembrolizumab: ARTISTRY-1 Trial

    Data presented from the ongoing ARTISTRY-1 study focused on the subset of PD-1/L1 unapproved patients with progressive, resistant ovarian cancer who received ALKS 4230 administered intravenously in combination with pembrolizumab. These data provide an updated and more in-depth view of responses previously reported at the 2020 European Society for Medical Oncology (ESMO) Virtual Congress. In addition, new data on the effects of IV ALKS 4230 monotherapy on the tumor microenvironment (TME) and additional updates from other tumor types were presented.   

    • Of the 13 evaluable ovarian cancer patients in the PD-1/L1 unapproved cohort, five patients with platinum-resistant ovarian cancer experienced clinical benefit, both in terms of durability and deepening of response. As of the data cutoff date, these five patients remained on therapy for a range of approximately 5 to 21 months.  
    • Antitumor activity has also been observed in patients with certain other women's cancers who received IV ALKS 4230 in combination with pembrolizumab, including a durable immune partial response in triple negative breast cancer and a new partial response in cervical cancer.
    • An analysis of paired biopsies taken from a melanoma patient who received the 6 µg/kg/day monotherapy dose of IV ALKS 4230 in the dose-escalation phase of ARTISTRY-1 showed an increase in tumor-infiltrating CD8+ T cells and an increase in PD-L1 expression in the TME. In addition, the ratio of CD8+ T cells to Treg cells increased in this patient. High CD8+ T cell/Treg cell ratios, independent of treatment type, have been reported to be associated with better prognosis among multiple tumor types, including ovarian tumors.2 These data provide supporting evidence of ALKS 4230's immunostimulatory impact on the TME and provide rationale for combining ALKS 4230 with pembrolizumab in ovarian cancer patients.
    • Among patients in the PD-1/L1 unapproved cohort, treatment-related AEs have been generally transient and manageable, with the majority being grade 1 or 2 in severity. The most commonly reported AEs in this cohort were chills, fever and nausea.
    • Based on the durable and deepening responses observed with ALKS 4230 in combination with pembrolizumab in ovarian cancer, the company is planning a new prospective study to evaluate this combination regimen in platinum-resistant and bevacizumab-experienced ovarian cancer patients.

    About ALKS 4230

    ALKS 4230 is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of ALKS 4230 is designed to leverage the proven antitumor effects of existing IL-2 therapy while mitigating certain limitations.

    About the ARTISTRY Clinical Development Program 

    ARTISTRY is an Alkermes-sponsored clinical development program evaluating ALKS 4230 in patients with advanced solid tumors.

    ARTISTRY-1 and ARTISTRY-2 are phase 1/2 studies evaluating the safety, tolerability, efficacy and pharmacokinetic and pharmacodynamic effects of ALKS 4230 in patients with refractory advanced solid tumors, in both monotherapy and combination settings with the PD-1 inhibitor pembrolizumab (KEYTRUDA®). In ARTISTRY-1, ALKS 4230 is administered as an intravenous infusion daily for five consecutive days. In ARTISTRY-2, ALKS 4230 is administered subcutaneously and is being evaluated with once-weekly and once-every-three-week dosing schedules.

    ARTISTRY-3 is a phase 2 study evaluating the clinical and immunologic effects of ALKS 4230 monotherapy administered intravenously on the tumor microenvironment of a variety of advanced, malignant solid tumors.

    About Alkermes

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders, and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    Note Regarding Forward-Looking Statements

    Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the potential therapeutic value of ALKS 4230 as a cancer immunotherapy when used as monotherapy or in combination across multiple tumor types; and the details and status of, and plans for, the clinical development of ALKS 4230, including the timing for identification of the recommended phase 2 dose of SC ALKS 4230 for ARTISTRY 2, potential regulatory strategies to support expeditious development paths of ALKS 4230 in monotherapy and combination settings, and the company's plans for a new study to evaluate ALKS 4230 in combination with pembrolizumab in platinum-resistant and bevacizumab-experienced ovarian cancer patients. You are cautioned that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others, whether ALKS 4230, as a monotherapy or in combination, could be shown to be unsafe or ineffective; whether preclinical results and data from ongoing clinical studies for ALKS 4230—whether as a monotherapy or in combination—will be predictive of future or final results from such studies, results of future clinical studies or real-world results; whether future clinical trials or future stages of ongoing clinical trials for ALKS 4230, as a monotherapy or in combination, will be initiated or completed on time or at all; changes in the cost, scope and duration of, and clinical trial operations for, development activities for ALKS 4230, including changes relating to the impact of the novel coronavirus (COVID-19) pandemic; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2019, the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

    KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp.

    1.  Ni L, Lu J. Cancer Med. 2018;7:4509–4516. 10.1002

    2.  Sato E, et al. Proc Natl Acad Sci U S A. 2005;102(51):18538-18543

    Alkermes Contacts:

    For Investors: Sandy Coombs, +1 781 609 6377

    For Media: Sourojit Bhowmick, Ph.D.,+1 781 609 6397

    Alkermes plc Logo (PRNewsfoto/Alkermes plc)

     

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  11. DUBLIN, Oct. 29, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) announces that the conference call to discuss the company's third quarter financial results is rescheduled due to technical difficulties impacting the conference call provider.  The company now plans to host the conference call and webcast presentation at 10:30 a.m. ET (2:30 p.m. GMT) on Thursday, Oct. 29, 2020.

    The webcast player and accompanying slides may be accessed on the Investors section of Alkermes' website at www.alkermes.com. The conference call may be accessed by dialing +1 844 602 0380 for U.S. callers and +1 862 298 0970 for international callers. The conference ID is 81030951.

    A replay of the conference call will be available through Thursday Nov. 5, 2020, and may…

    DUBLIN, Oct. 29, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) announces that the conference call to discuss the company's third quarter financial results is rescheduled due to technical difficulties impacting the conference call provider.  The company now plans to host the conference call and webcast presentation at 10:30 a.m. ET (2:30 p.m. GMT) on Thursday, Oct. 29, 2020.

    The webcast player and accompanying slides may be accessed on the Investors section of Alkermes' website at www.alkermes.com. The conference call may be accessed by dialing +1 844 602 0380 for U.S. callers and +1 862 298 0970 for international callers. The conference ID is 81030951.

    A replay of the conference call will be available through Thursday Nov. 5, 2020, and may be accessed by visiting Alkermes' website.  

    About Alkermes plc

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    Alkermes Contact:

    Alex Braun

    Investor Relations

    +1 781 296 8493

    Alkermes plc Logo (PRNewsfoto/Alkermes plc)

     

     

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  12. DUBLIN, Oct. 29, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today reported financial results for the third quarter of 2020 and provided updated financial expectations for full-year 2020.

    "Over the past several months, we achieved a number of important milestones in our development programs against the backdrop of strong commercial execution and disciplined management of our expenses. The positive outcome of the ALKS 3831 FDA Advisory Committee meeting and the presentation of accumulating data for ALKS 4230, including monotherapy responses observed in melanoma, were significant achievements that underscore the potential value of these investigational medicines," said Richard Pops, Chief Executive Officer of Alkermes. "As we look ahead…

    DUBLIN, Oct. 29, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today reported financial results for the third quarter of 2020 and provided updated financial expectations for full-year 2020.

    "Over the past several months, we achieved a number of important milestones in our development programs against the backdrop of strong commercial execution and disciplined management of our expenses. The positive outcome of the ALKS 3831 FDA Advisory Committee meeting and the presentation of accumulating data for ALKS 4230, including monotherapy responses observed in melanoma, were significant achievements that underscore the potential value of these investigational medicines," said Richard Pops, Chief Executive Officer of Alkermes. "As we look ahead, we will continue to focus on our strategic imperatives: commercial execution, including preparations for the potential launch of ALKS 3831, aggressive development of our pipeline candidates, and efficient management of our operating cost structure, as we position the company for long-term value creation."

    Quarter Ended Sept. 30, 2020 Financial Highlights

    • Total revenues for the quarter were $265.0 million, compared to $255.2 million for the same period in the prior year.
    • Net loss according to generally accepted accounting principles in the U.S. (GAAP) was $0.1 million for the quarter, or a GAAP net loss per share of $0.00. This compared to GAAP net loss of $52.9 million, or a GAAP net loss per share of $0.34, for the same period in the prior year.
    • Non-GAAP net income was $41.5 million for the quarter, or a non-GAAP basic and diluted earnings per share of $0.26. This compared to non-GAAP net loss of $7.0 million, or a non-GAAP basic and diluted loss per share of $0.04, for the same period in the prior year.

    Quarter Ended Sept. 30, 2020 Financial Results

    Revenues

    • Net sales of proprietary products were $142.7 million, compared to $138.8 million for the same period in the prior year.
      • Net sales of VIVITROL were $80.3 million, compared to $85.2 million for the same period in the prior year, representing a decrease of 6%, due primarily to COVID-19 pandemic-related disruptions. Sequentially, net sales of VIVITROL increased 12%, driven by increased demand during the quarter.
      • Net sales of ARISTADAi were $62.4 million, compared to $53.6 million for the same period in the prior year, representing an increase of 16%, driven primarily by continued growth of the ARISTADA provider base and growth of the ARISTADA two-month dose.
    • Manufacturing and royalty revenues were $120.4 million, compared to $103.8 million for the same period in the prior year.
      • Manufacturing and royalty revenues from RISPERDAL CONSTA®, INVEGA SUSTENNA®/XEPLION® and INVEGA TRINZA®/TREVICTA® were $87.9 million, compared to $76.7 million for the same period in the prior year, primarily driven by an increase in royalty revenue from INVEGA SUSTENNA and the timing of manufacturing shipments of RISPERDAL CONSTA.

    Costs and Expenses

    • Total operating expenses were $275.7 million, compared to $308.9 million for the same period in the prior year. This decrease reflects the impact of the restructuring implemented in 2019 and expense management measures in 2020.
      • Research and Development (R&D) expenses were $95.0 million, compared to $107.7 million for the same period in the prior year.
      • Selling, General and Administrative (SG&A) expenses were $127.7 million, compared to $148.7 million for the same period in the prior year.

    Balance Sheet

    • At Sept. 30, 2020, Alkermes recorded cash, cash equivalents and total investments of $597.2 million, compared to $539.6 million at June 30, 2020, driven by the company's operating results and changes in working capital. The company's total debt outstanding as of Sept. 30, 2020 was $275.5 million under its term loan, which matures in March 2023.

    "Our third quarter results reflect strong commercial execution, with the sequential growth of both VIVITROL and ARISTADA net sales within a complex and dynamic COVID-19 market environment. Today, we are pleased to be raising our financial guidance for 2020 to reflect this solid performance. Importantly, expectations for 2020 non-GAAP net income are back in line with the expectations provided in February prior to the impact of COVID-19, primarily due to disciplined management of our expenses," commented James Frates, Chief Financial Officer of Alkermes. "As we approach the end of 2020, we believe we are well-positioned to execute on our strategic imperatives to drive long-term profitability and growth."

    Financial Expectations for 2020

    The following financial expectations for 2020 are based on recent trends and assume that treatment provider practices and patient access to the company's commercial products continue to normalize. New COVID-19-related restrictions or a resurgence of COVID-19 could impact the company's ability to meet these expectations. All line items are according to GAAP, except as otherwise noted.

    In millions (except per share amounts)



    Current 2020 Expectation

    (Provided 10/29/20)

    Previous Expectation

    (Provided 7/29/20)









    Total Revenue



    $1,010 – $1,035

    $965 – $1,005

    VIVITROL Net Sales



    $305 – $315

    $270 – $300

    ARISTADA Net Sales



    $230 – $240

    $220 – $235

    Cost of Goods Sold



    $180 – $190

    $180 – $190

    R&D Expenses



    $375 – $390

    $370 – $395

    SG&A Expenses



    $530 – $545

    $525 – $550

    Amortization of Intangible Assets



    ~$40

    ~$40

    Other Income, Net



    ~$30

    $10 – $15

    Income Tax Expense



    $10 – $15

    $10 – $15

    GAAP Net Loss



    ($95) – ($115)

    ($145) – ($175)

    GAAP Net Loss per Share



    ($0.60) – ($0.72)

    ($0.91) – ($1.10)

    Non-GAAP Net Income



    $50 – $70

    $0 – $30

    Non-GAAP Diluted EPS



    $0.31 – $0.43

    $0.00 – $0.19

    Capital Expenditures



    ~$35

    ~$35

    Recent Events

    • Psychiatry portfolio
      • In October 2020, announced positive vote outcomes from the joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the U.S. Food and Drug Administration (FDA), on questions relating to ALKS 3831 for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. The joint advisory committee's recommendations, while not binding, will be considered by the FDA in its review of the ALKS 3831 New Drug Application (NDA). The Prescription Drug User Fee Act (PDUFA) target action date for the ALKS 3831 NDA is Nov. 15, 2020.
      • In September 2020, presented new real-world outcomes research and clinical data related to Alkermes' psychiatry portfolio at the Psych Congress 2020 Virtual Experience, including new outcomes research that analyzed treatment challenges of second-generation antipsychotics, such as weight gain and treatment interruptions, for patients living with schizophrenia or bipolar I disorder.
      • In August 2020, announced the publication in the peer-reviewed American Journal of Psychiatry of results from the phase 3 ENLIGHTEN-2 clinical trial of ALKS 3831. ENLIGHTEN-2 was a six-month study evaluating the weight gain profile of ALKS 3831 compared to olanzapine in 561 patients with stable schizophrenia. Positive topline data from the ENLIGHTEN-2 study were first reported in November 2018.
    • ALKS 4230
      • In September 2020, presented new clinical data updates from ARTISTRY-1, an ongoing phase 1/2 study evaluating Alkermes' investigational engineered interleukin-2 variant immunotherapy, ALKS 4230, administered intravenously as monotherapy and in combination with the PD-1 inhibitor pembrolizumab in patients with refractory solid tumors, at the 2020 European Society for Medical Oncology (ESMO) Virtual Congress. The company also announced the expansion of the ARTISTRY-1 monotherapy melanoma cohort based on the achievement of protocol-defined efficacy response criteria.
      • In August 2020, announced the initiation of ARTISTRY-3, a phase 2 study evaluating the clinical and immunologic effects of ALKS 4230 monotherapy administered intravenously on the tumor microenvironment in a variety of advanced, malignant solid tumors.

    Conference Call

    Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (12:00 p.m. GMT) on Thursday, Oct. 29, 2020, to discuss these financial results, financial expectations, and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes' website at www.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 will be available from 11:00 a.m. ET (3:00 p.m. GMT) on Thursday, Oct. 29, 2020, through Thursday, Nov. 5, 2020, and may be accessed by visiting Alkermes' website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay conference ID is 13712082.

    About Alkermes plc

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    Non-GAAP Financial Measures

    This press release includes information about certain financial measures that are not prepared in accordance with GAAP, including non-GAAP net income (loss) and non-GAAP basic and diluted earnings (loss) per share. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies.

    Non-GAAP net income (loss) adjusts for one-time and non-cash charges by excluding from GAAP results: share-based compensation expense; amortization; depreciation; non-cash net interest expense; changes in the fair value of the contingent consideration; certain other one-time or non-cash items; and the income tax effect of these reconciling items.

    The company's management and the Board utilize these non-GAAP financial measures to evaluate the company's performance. The company provides these non-GAAP measures of the company's performance to investors because management believes that these non-GAAP financial measures, when viewed with the company's results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, non-GAAP net income (loss) and non-GAAP basic and diluted earnings (loss) per share are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, non-GAAP net income (loss) and non-GAAP basic and diluted earnings (loss) per share should not be considered measures of the company's liquidity.

    A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release.

    Note Regarding Forward-Looking Statements

    Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company's expectations concerning future financial and operating performance, business plans or prospects, including the anticipated ongoing impacts of COVID-19 on the company's business and financial performance, the company's assumptions with respect to continued normalization of patient and healthcare provider practices, and the company's ability to drive long-term value creation and profitability; the potential therapeutic and commercial value of the company's marketed and development products; the company's expectations concerning future development activities for the company's development candidates; the company's expectations regarding the FDA's review of the ALKS 3831 NDA, including the FDA's PDUFA target action date for the NDA; and expectations concerning the company's commercial activities, including the potential launch of ALKS 3831. The company cautions that forward-looking statements are inherently uncertain. The forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: the impacts of the ongoing COVID-19 pandemic and continued efforts to mitigate its spread on the company's business, results of operations or financial condition, including: impacts on the vendors or distribution channels in its supply chain, and the company's ability to continue to manufacture its products; impacts on its ability to continue its discovery activities; impacts on the conduct of its clinical trials, including with respect to enrollment rates, availability of investigators and clinical trial sites and monitoring of data; impacts on healthcare systems that serve people living with opioid dependence, alcohol dependence and schizophrenia and on patient and healthcare provider access to the company's medicines; impacts on the regulatory agencies with which the company interacts in the development, review, approval and commercialization of its medicines; impacts on reimbursement for the company's products, including its Medicaid rebate liability, and for services related to the use of its products; and impacts on the U.S., Irish and/or global economies more broadly; the unfavorable outcome of litigation, including so-called "Paragraph IV" litigation and other patent litigation, related to any of the company's products or products using the company's proprietary technologies, which may lead to competition from generic drug manufacturers; clinical development activities may not be completed on time or at all; the results of the company's clinical development activities may not be positive, or predictive of real-world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products, such as decisions not to approve the company's NDAs, including the NDA for ALKS 3831; data from clinical trials may be interpreted by the FDA in different ways than the company or an advisory committee interprets it; the FDA may not agree with the company's regulatory approval strategies or components of its ALKS 3831 NDA or other regulatory filings, including the company's clinical trial designs, conduct and methodologies, manufacturing processes and facilities, and the adequacy of the data and other information included in its filings to meet the FDA's requirements for approval, including the risk/benefit profile of the company's product candidates; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2019, the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission ("SEC"), which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

    Trademarks

    VIVITROL® is a registered trademark of Alkermes, Inc.; ARISTADA® and ARISTADA INITIO® are registered trademarks of Alkermes Pharma Ireland Limited; and RISPERDAL CONSTA®, INVEGA SUSTENNA®, XEPLION®, INVEGA TRINZA® and TREVICTA® are registered trademarks of Johnson & Johnson.

     (tables follow)

    Alkermes plc and Subsidiaries

    Selected Financial Information (Unaudited)











    Condensed Consolidated Statements of Operations - GAAP



    Three Months Ended 



    Three Months Ended 

    (In thousands, except per share data)



    September 30, 2020



    September 30, 2019

    Revenues:









    Product sales, net



    $                  142,658



    $                  138,774

    Manufacturing and royalty revenues



    120,351



    103,783

    Research and development revenue



    953



    12,686

    License revenue



    1,050



    Total Revenues



    265,012



    255,243

    Expenses:









    Cost of goods manufactured and sold



    43,129



    42,319

    Research and development



    94,980



    107,671

    Selling, general and administrative



    127,653



    148,701

    Amortization of acquired intangible assets



    9,917



    10,173

    Total Expenses



    275,679



    308,864

    Operating Loss



    (10,667)



    (53,621)

    Other Income (Expense), net:









    Interest income



    1,376



    3,509

    Interest expense



    (1,811)



    (3,385)

    Change in the fair value of contingent consideration



    3,926



    1,300

    Other income (expense), net



    9,368



    (1,664)

    Total Other Income (Expense), net



    12,859



    (240)

    Income (Loss) Before Income Taxes



    2,192



    (53,861)

    Provision (Benefit) for Income Taxes



    2,326



    (983)

    Net Loss — GAAP



    $                       (134)



    $                  (52,878)











    (Loss) Earnings Per Share:









    GAAP loss per share — basic and diluted



    $                      (0.00)



    $                      (0.34)

    Non-GAAP earnings (loss) per share — basic and diluted



    $                        0.26



    $                      (0.04)











    Weighted Average Number of Ordinary Shares Outstanding:









    Basic and diluted — GAAP



    159,062



    157,199

    Basic — Non-GAAP



    159,062



    157,199

    Diluted — Non-GAAP



    160,335



    157,199











    An itemized reconciliation between net loss on a GAAP basis and non-GAAP net income (loss) is as follows:

    Net Loss — GAAP



    $                       (134)



    $                  (52,878)

    Adjustments:









    Share-based compensation expense



    22,618



    26,729

    Depreciation expense



    10,663



    10,173

    Amortization expense



    9,917



    10,173

    Income tax effect related to reconciling items



    2,174



    155

    Non-cash net interest expense



    166



    168

    Change in the fair value of contingent consideration



    (3,926)



    (1,300)

    Change in the fair value of warrants





    (206)

    Non-GAAP Net Income (Loss)



    $                    41,478



    $                    (6,986)





















    Condensed Consolidated Statements of Operations - GAAP



    Nine Months Ended 



    Nine Months Ended 

    (In thousands, except per share data)



    September 30, 2020



    September 30, 2019

    Revenues:









    Product sales, net



    $                  402,799



    $                  374,890

    Manufacturing and royalty revenues



    353,107



    340,595

    Research and development revenue



    1,805



    41,732

    License Revenue



    1,050



    1,000

    Total Revenues



    758,761



    758,217

    Expenses:









    Cost of goods manufactured and sold



    135,394



    133,903

    Research and development



    282,481



    314,676

    Selling, general and administrative



    393,049



    444,996

    Amortization of acquired intangible assets



    29,535



    30,187

    Total Expenses



    840,459



    923,762

    Operating Loss



    (81,698)



    (165,545)

    Other Income (Expense), net:









      Interest income



    5,924



    10,785

      Interest expense



    (6,790)



    (10,405)

      Change in the fair value of contingent consideration



    16,626



    (27,800)

      Other income (expense), net



    11,047



    (1,534)

    Total Other Income (Expense), net



    26,807



    (28,954)

    Loss Before Income Taxes



    (54,891)



    (194,499)

    Provision (Benefit) for Income Taxes



    13,328



    (3,233)

    Net Loss — GAAP



    $                  (68,219)



    $                (191,266)











    (Loss) Earnings Per Share:









    GAAP loss per share — basic and diluted



    $                      (0.43)



    $                      (1.22)

    Non-GAAP earnings (loss) per share — basic and diluted



    $                        0.33



    $                      (0.12)











    Weighted Average Number of Ordinary Shares Outstanding:









    Basic and diluted — GAAP



    158,685



    156,845

    Basic — Non-GAAP



    158,685



    156,845

    Diluted — Non-GAAP



    159,467



    156,845











    An itemized reconciliation between net loss on a GAAP basis and non-GAAP net income (loss) is as follows:

    Net Loss — GAAP



    $                  (68,219)



    $                (191,266)

    Adjustments:









    Share-based compensation expense



    65,277



    79,590

    Depreciation expense



    31,991



    29,715

    Amortization expense



    29,535



    30,187

    Income tax effect related to reconciling items



    8,971



    5,170

    Non-cash net interest expense



    500



    505

    Change in the fair value of contingent consideration



    (16,626)



    27,800

    Acquisition of IPR&D



    674



    Change in the fair value of warrants





    (907)

    Non-GAAP Net Income (Loss)



    $                    52,103



    $                  (19,206)





















    Condensed Consolidated Balance Sheets



    September 30, 



    December 31, 

    (In thousands)



    2020



    2019

    Cash, cash equivalents and total investments



    $                  597,156



    $                  614,370

    Receivables



    265,644



    257,086

    Contract assets



    14,395



    8,386

    Inventory



    122,823



    101,803

    Prepaid expenses and other current assets



    52,697



    59,716

    Property, plant and equipment, net



    355,215



    362,168

    Intangible assets, net and goodwill



    213,981



    243,516

    Other assets



    254,909



    158,358

    Total Assets



    $               1,876,820



    $               1,805,403

    Long-term debt — current portion



    $                      2,843



    $                      2,843

    Other current liabilities



    375,308



    388,269

    Long-term debt   



    272,663



    274,295

    Contract liabilities — long-term 



    18,635



    22,068

    Other long-term liabilities



    123,013



    32,486

    Total shareholders' equity



    1,084,357



    1,085,442

    Total Liabilities and Shareholders' Equity



    $               1,876,820



    $               1,805,403











    Ordinary shares outstanding (in thousands)



    159,105



    157,779











    This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in

    Alkermes plc's Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2020, which the company intends to file

    in October 2020.





    An itemized reconciliation between projected loss per share on a GAAP basis and projected earnings per share

    on a non-GAAP basis is as follows:



    (In millions, except per share data)



    Amount



    Shares



    (Loss)

    Earnings

    Per Share

    Projected Net Loss — GAAP



    $                    (105.0)



    159



    $       (0.66)

       Adjustments:













       Share-based compensation expense



    92.5









       Depreciation expense



    42.5









       Amortization expense



    40.0









       Income tax effect related to reconciling items 



    6.5









       Non-cash net interest expense



    1.0









       Change in the fair value of contingent consideration



    (17.5)









    Projected Net Income — Non-GAAP



    $                        60.0



    161



    $        0.37



    Projected GAAP and non-GAAP measures reflect mid-points within ranges of estimated guidance.

     

    i The term "ARISTADA" as used in this press release refers to ARISTADA and ARISTADA INITIO, unless the context indicates otherwise.

     

    Alkermes Contacts:

    For Investors: Sandy Coombs      +1 781 609 6377

    For Media:      Katie Joyce      +1 781 249 8927

    Alkermes plc Logo (PRNewsfoto/Alkermes plc)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/alkermes-plc-reports-third-quarter-2020-financial-results-and-raises-2020-financial-expectations-301162481.html

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  13. DUBLIN, Oct. 22, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) will host a conference call and webcast presentation at 8:00 a.m. ET (12:00 p.m. GMT) on Thursday, Oct. 29, 2020 to discuss the company's third quarter 2020 financial results. Management will also provide an update on the company.

    The webcast player and accompanying slides may be accessed on the Investors section of Alkermes' website at www.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.

    A replay of the conference call will be available from 11:00 a.m. ET (3:00 p.m. GMT) on Thursday, Oct. 29, 2020, through Thursday Nov. 5, 2020, and may be accessed by visiting Alkermes' website or by dialing…

    DUBLIN, Oct. 22, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) will host a conference call and webcast presentation at 8:00 a.m. ET (12:00 p.m. GMT) on Thursday, Oct. 29, 2020 to discuss the company's third quarter 2020 financial results. Management will also provide an update on the company.

    The webcast player and accompanying slides may be accessed on the Investors section of Alkermes' website at www.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.

    A replay of the conference call will be available from 11:00 a.m. ET (3:00 p.m. GMT) on Thursday, Oct. 29, 2020, through Thursday Nov. 5, 2020, and may be accessed by visiting Alkermes' website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay access code is 13712082. 

    About Alkermes plc

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    Alkermes Contact:

    Alex Braun

    Investor Relations

    +1 781 296 8493

    Alkermes plc Logo (PRNewsfoto/Alkermes plc)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/alkermes-to-host-conference-call-to-discuss-third-quarter-2020-financial-results-301158333.html

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  14. DUBLIN, Oct. 9, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced positive voting outcomes from the joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the U.S. Food and Drug Administration (FDA). The committees met to discuss ALKS 3831 (olanzapine/samidorphan), an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. The committees jointly voted that samidorphan meaningfully mitigates olanzapine-associated weight gain (16 yes, 1 no) and that the safety profile of ALKS 3831 has been adequately characterized (13 yes…

    DUBLIN, Oct. 9, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced positive voting outcomes from the joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the U.S. Food and Drug Administration (FDA). The committees met to discuss ALKS 3831 (olanzapine/samidorphan), an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. The committees jointly voted that samidorphan meaningfully mitigates olanzapine-associated weight gain (16 yes, 1 no) and that the safety profile of ALKS 3831 has been adequately characterized (13 yes, 3 no, 1 abstention). 

    "The favorable outcome of today's joint advisory committee meeting represents an important milestone for the patients, clinicians and families who may benefit from new medicines for the treatment of schizophrenia and bipolar I disorder. The personal testimonies shared during today's open public hearing reinforced the need for treatment approaches that consider patients' overall mental and physical health," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "The ALKS 3831 development program is part of our ongoing commitment to develop new therapeutic options for adults living with serious mental illness. Today's outcome marks an important step for this program and we look forward to working with the FDA as it completes its review of the ALKS 3831 New Drug Application."

    In addition, the committees jointly voted that labeling is sufficient to mitigate the risks related to the opioid antagonist action of samidorphan (11 yes, 6 no). Alkermes' proposed labeling contraindicates the use of ALKS 3831 in patients who are opioid-dependent or chronically using opioids, and the company has proposed a comprehensive education plan, which includes dissemination of information to potential prescribers and pharmacists.

    The joint advisory committee's recommendations, while not binding, will be considered by the FDA in its review of the ALKS 3831 New Drug Application (NDA). The Prescription Drug User Fee Act (PDUFA) target action date for the ALKS 3831 NDA is Nov. 15, 2020.

    The NDA submission and clinical development program for ALKS 3831 are supported by data from 27 clinical studies, including 18 studies evaluating ALKS 3831 and nine studies evaluating samidorphan alone.

    About ALKS 3831

    ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. ALKS 3831 is composed of samidorphan, a novel, new molecular entity, co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.

    About Schizophrenia 

    Schizophrenia is a serious brain disorder marked by positive symptoms (hallucinations and delusions, disorganized speech and thoughts, and agitated or repeated movements) and negative symptoms (depression, blunted emotions and social withdrawal).1 An estimated 2.4 million American adults have schizophrenia,2 with men and women affected equally.

    About Bipolar I Disorder

    Bipolar disorder is a brain disorder that causes shifts in a person's mood, energy and ability to function. Individuals with this brain disorder may experience debilitating mood shifts from extreme highs (mania) to extreme lows (depression). Bipolar I disorder is characterized by the occurrence of at least one manic episode, with or without the occurrence of a major depressive episode, and affects approximately one percent of the adult population in the United States in any given year.3

    About Alkermes plc

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    Note Regarding Forward-Looking Statements

    Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the potential therapeutic and commercial value of ALKS 3831 for the treatment of adults with schizophrenia and the treatment of adults with bipolar I disorder; and the company's expectations regarding the FDA's review of the ALKS 3831 NDA, including the company's interactions with the FDA, the FDA's PDUFA target action date for the NDA and the adequacy of the data contained in the NDA to serve as the basis for approval of ALKS 3831 for the treatment of adults with schizophrenia and the treatment of adults with bipolar I disorder. The company cautions that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: data from the ALKS 3831 clinical development program may be interpreted by the FDA in different ways than the company or the advisory committee interprets it; the FDA may not agree with the company's regulatory approval strategy or components of the ALKS 3831 NDA , including the company's clinical trial designs, conduct and methodologies, manufacturing processes and facilities; the FDA's determination as to the clinical meaningfulness of the ALKS 3831 weight data, including the effects of ALKS 3831 on metabolic parameters; the FDA's views of the impact on the risk/benefit profile of ALKS 3831 of potential interactions of ALKS 3831 with opioids in the intended patient populations; the FDA's view of the adequacy and sufficiency of the preclinical and clinical results of the ALKS 3831 studies and the PK bridging data and other information included in the ALKS 3831 NDA to meet the FDA's requirements for approval for the proposed schizophrenia and bipolar I disorder indications; unanticipated impacts of the COVID-19 pandemic on the operations of the company, the FDA or other regulatory agencies involved in the review and potential approval of ALKS 3831; potential changes in the cost, scope and duration of the ALKS 3831 development and regulatory program; whether ALKS 3831 could be shown ineffective or unsafe during clinical studies; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2019, the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission ("SEC"), which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

    1American Psychiatric Association. Schizophrenia Spectrum and Other Psychiatric Disorders. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Washington, DC: American Psychiatric Publishing; 2013.

    National Institutes of Health. Schizophrenia. Accessed on Oct. 7, 2020 from https://archives.nih.gov/asites/report/09-09-2019/report.nih.gov/nihfactsheets/Pdfs/Schizophrenia(NIMH).pdf.

    Merikangas et al. Lifetime and 12-Month Prevalence of Bipolar Spectrum Disorder in the National Comorbidity Survey Replication. Arch Gen Psychiatry, 2007 May; 64(5): 543-552. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1931566/ 

    Alkermes Contacts:

    For Investors: Sandy Coombs,    +1 781 609 6377

    For Media:      Marisa Borgasano, +1 781 609 6659

    Alkermes plc Logo (PRNewsfoto/Alkermes plc)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/fda-advisory-committee-votes-in-support-of-alks-3831-for-the-treatment-of-schizophrenia-and-bipolar-i-disorder-301149686.html

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  15. DUBLIN, Oct. 9, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that Nasdaq has temporarily halted trading of the company's ordinary shares.

    The joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the U.S. Food and Drug Administration (FDA), will be held today to review the company's New Drug Application (NDA) for ALKS 3831 (olanzapine/samidorphan). ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and the treatment of adults with bipolar I disorder.

    The joint advisory committee meeting, which is being held virtually, is scheduled to begin at 10:00 a.m.

    DUBLIN, Oct. 9, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that Nasdaq has temporarily halted trading of the company's ordinary shares.

    The joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the U.S. Food and Drug Administration (FDA), will be held today to review the company's New Drug Application (NDA) for ALKS 3831 (olanzapine/samidorphan). ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and the treatment of adults with bipolar I disorder.

    The joint advisory committee meeting, which is being held virtually, is scheduled to begin at 10:00 a.m. ET. The briefing materials and webcast information can be found on the FDA website at: https://www.fda.gov/advisory-committees/advisory-committee-calendar/updated-time-agenda-and-meeting-materials-october-9-2020-joint-meeting-psychopharmacologic-drugs

    The Prescription Drug User Fee Act (PDUFA) target action date for the ALKS 3831 NDA is Nov. 15, 2020.

    About ALKS 3831

    ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. ALKS 3831 is composed of samidorphan, a novel, new molecular entity, co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.

    About Schizophrenia 

    Schizophrenia is a serious brain disorder marked by positive symptoms (hallucinations and delusions, disorganized speech and thoughts, and agitated or repeated movements) and negative symptoms (depression, blunted emotions and social withdrawal).1 An estimated 2.4 million American adults have schizophrenia,2 with men and women affected equally.

    About Bipolar I Disorder

    Bipolar disorder is a brain disorder that causes shifts in a person's mood, energy and ability to function. Individuals with this brain disorder may experience debilitating mood shifts from extreme highs (mania) to extreme lows (depression). Bipolar I disorder is characterized by the occurrence of at least one manic episode, with or without the occurrence of a major depressive episode, and affects approximately one percent of the adult population in the United States in any given year.3

    About Alkermes plc

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    Note Regarding Forward-Looking Statements

    Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the potential therapeutic and commercial value of ALKS 3831 for the treatment of adults with schizophrenia and the treatment of adults with bipolar I disorder; and the company's expectations regarding the FDA's PDUFA target action date for the ALKS 3831 NDA. The company cautions that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: unanticipated impacts of the COVID-19 pandemic on the operations of the company, the FDA or other regulatory agencies involved in the review and potential approval of ALKS 3831; potential changes in the cost, scope and duration of the ALKS 3831 development and regulatory program; whether ALKS 3831 could be shown ineffective or unsafe during clinical studies; data from the ALKS 3831 clinical development program may be interpreted by the FDA in different ways than the company interprets it; the FDA may not agree with the company's regulatory approval strategies or components of its NDA filing for ALKS 3831, including the company's clinical trial designs, conduct and methodologies, manufacturing processes and facilities; the FDA's determination as to the clinical meaningfulness of the ALKS 3831 weight data, including the effects of ALKS 3831 on metabolic parameters; FDA's views of the impact on the risk/benefit profile of ALKS 3831 of potential interactions of ALKS 3831 with opioids in the intended patient populations; and the adequacy of the preclinical and clinical results of the ALKS 3831 studies and the PK bridging data and other information included in the ALKS 3831 NDA to meet the FDA's requirements for approval for the proposed schizophrenia and bipolar I disorder indications;  and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2019, the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission ("SEC"), which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

    1American Psychiatric Association. Schizophrenia Spectrum and Other Psychiatric Disorders. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Washington, DC: American Psychiatric Publishing; 2013.

    National Institutes of Health. Schizophrenia. Accessed on Oct. 8, 2020 from https://archives.nih.gov/asites/report/09-09-2019/report.nih.gov/nihfactsheets/Pdfs/Schizophrenia(NIMH).pdf.

    Merikangas et al. Lifetime and 12-Month Prevalence of Bipolar Spectrum Disorder in the National Comorbidity Survey Replication. Arch Gen Psychiatry, 2007 May; 64(5): 543–552. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1931566/

    Alkermes Contacts:

    For Investors: Sandy Coombs,    +1 781 609 6377

    For Media:      Marisa Borgasano, +1 781 609 6659

    Alkermes plc Logo (PRNewsfoto/Alkermes plc)

     

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  16. DUBLIN, Oct. 7, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the Oct. 9, 2020 joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to review the company's New Drug Application (NDA) for ALKS 3831 (olanzapine/samidorphan). ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder.

    The joint advisory committee meeting, which is being held virtually, is scheduled to begin at 10:00 a.m. ET on Friday, Oct. 9, 2020. Both Alkermes…

    DUBLIN, Oct. 7, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the Oct. 9, 2020 joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to review the company's New Drug Application (NDA) for ALKS 3831 (olanzapine/samidorphan). ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder.

    The joint advisory committee meeting, which is being held virtually, is scheduled to begin at 10:00 a.m. ET on Friday, Oct. 9, 2020. Both Alkermes and the FDA have prepared pre-recorded presentations, which will be viewed by the joint advisory committee prior to the meeting and will not be replayed during the meeting. The briefing materials, including the pre-recorded presentation slides and transcripts, are now posted to the FDA website and can be accessed here: https://www.fda.gov/advisory-committees/advisory-committee-calendar/updated-time-agenda-and-meeting-materials-october-9-2020-joint-meeting-psychopharmacologic-drugs.

    The FDA has also established a docket for public comment on this meeting. The docket number is FDA-2020-N-1767 and can be accessed here: https://beta.regulations.gov/document/FDA-2020-N-1767-0001/comment.

    The Prescription Drug User Fee Act (PDUFA) target action date for the ALKS 3831 NDA is Nov. 15, 2020.

    About ALKS 3831

    ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. ALKS 3831 is composed of samidorphan, a novel, new molecular entity, co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.

    About Schizophrenia 

    Schizophrenia is a serious brain disorder marked by positive symptoms (hallucinations and delusions, disorganized speech and thoughts, and agitated or repeated movements) and negative symptoms (depression, blunted emotions and social withdrawal).1 An estimated 2.4 million American adults have schizophrenia,2 with men and women affected equally.

    About Bipolar I Disorder

    Bipolar disorder is a brain disorder that causes shifts in a person's mood, energy and ability to function. Individuals with this brain disorder may experience debilitating mood shifts from extreme highs (mania) to extreme lows (depression). Bipolar I disorder is characterized by the occurrence of at least one manic episode, with or without the occurrence of a major depressive episode, and affects approximately one percent of the adult population in the United States in any given year.3

    About Alkermes plc

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    Note Regarding Forward-Looking Statements

    Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the potential therapeutic and commercial value of ALKS 3831 for the treatment of adults with schizophrenia and the treatment of adults with bipolar I disorder; and the company's expectations regarding the FDA's PDUFA target action date for the ALKS 3831 NDA. The company cautions that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: unanticipated impacts of the COVID-19 pandemic on the operations of the company, the FDA or other regulatory agencies involved in the review and potential approval of ALKS 3831; potential changes in the cost, scope and duration of the ALKS 3831 development and regulatory program; whether ALKS 3831 could be shown ineffective or unsafe during clinical studies; data from the ALKS 3831 clinical development program may be interpreted by the FDA in different ways than the company interprets it; the FDA may not agree with the company's regulatory approval strategies or components of its NDA filing for ALKS 3831, including the company's clinical trial designs, conduct and methodologies, manufacturing processes and facilities; the FDA's determination as to the clinical meaningfulness of the ALKS 3831 weight data, including the effects of ALKS 3831 on metabolic parameters; the FDA's views of the impact on the risk/benefit profile of ALKS 3831 of potential interactions of ALKS 3831 with opioids in the intended patient populations; and the adequacy of the preclinical and clinical results of the ALKS 3831 studies and the PK bridging data and other information included in the ALKS 3831 NDA to meet the FDA's requirements for approval for the proposed schizophrenia and bipolar I disorder indications; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2019, the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission ("SEC"), which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

    1American Psychiatric Association. Schizophrenia Spectrum and Other Psychiatric Disorders. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Washington, DC: American Psychiatric Publishing; 2013.

    National Institutes of Health. Schizophrenia. Accessed on Oct. 6, 2020 from https://archives.nih.gov/asites/report/09-09-2019/report.nih.gov/nihfactsheets/Pdfs/Schizophrenia(NIMH).pdf.

    Merikangas et al. Lifetime and 12-Month Prevalence of Bipolar Spectrum Disorder in the National Comorbidity Survey Replication. Arch Gen Psychiatry, 2007 May; 64(5): 543–552. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1931566/

    Alkermes Contacts:

    For Investors: Sandy Coombs, +1 781 609 6377

    For Media: Marisa Borgasano, +1 781 609 6659

    Alkermes plc Logo (PRNewsfoto/Alkermes plc)

     

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  17. DUBLIN, Sept. 18, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today presented new clinical data from ARTISTRY-1, an ongoing phase 1/2 study evaluating Alkermes' investigational engineered interleukin-2 (IL-2) variant immunotherapy, ALKS 4230, administered intravenously as monotherapy and in combination with the PD-1 inhibitor pembrolizumab (KEYTRUDA®) in patients with refractory solid tumors. Data from the ongoing ARTISTRY-1 study showed encouraging single-agent activity of ALKS 4230 in melanoma and durable responses in multiple tumor types in combination with pembrolizumab. The most frequently observed treatment-emergent adverse events (AEs) in both the monotherapy and combination cohorts were transient fever and chills, consistent with…

    DUBLIN, Sept. 18, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today presented new clinical data from ARTISTRY-1, an ongoing phase 1/2 study evaluating Alkermes' investigational engineered interleukin-2 (IL-2) variant immunotherapy, ALKS 4230, administered intravenously as monotherapy and in combination with the PD-1 inhibitor pembrolizumab (KEYTRUDA®) in patients with refractory solid tumors. Data from the ongoing ARTISTRY-1 study showed encouraging single-agent activity of ALKS 4230 in melanoma and durable responses in multiple tumor types in combination with pembrolizumab. The most frequently observed treatment-emergent adverse events (AEs) in both the monotherapy and combination cohorts were transient fever and chills, consistent with anticipated effects of immunotherapy. These data are being presented in a mini oral presentation at the 2020 European Society for Medical Oncology (ESMO) Virtual Congress, held Sept. 18-21. The company also announced today the expansion of the ARTISTRY-1 monotherapy melanoma cohort based on achievement of protocol-defined efficacy response criteria.

    "New treatment options are needed to improve clinical outcomes in many cancer types. Current immunotherapies are not an option for all cancer types and only a portion of eligible patients respond to them," said Ulka N. Vaishampayan, M.D., Lead Investigator and Professor, Internal Medicine, Division of Hematology/Oncology, University of Michigan. "The monotherapy anti-tumor efficacy and the durable responses in the combination cohorts in multiple tumor types, including heavily pretreated platinum-resistant ovarian cancer, triple-negative breast cancer and esophageal cancer, provide additional insights into ALKS 4230's potential as a treatment option for patients with advanced tumors that may not respond to the current standard of care."

    Data highlights include:

    ALKS 4230 Monotherapy

    The monotherapy expansion stage of ARTISTRY-1 is evaluating the recommended phase 2 dose of ALKS 4230 (6 µg/kg/day) administered intravenously in patients with refractory melanoma or refractory renal cell carcinoma (RCC). A total of 15 patients across both monotherapy cohorts were treated, with responses observed in melanoma. (Data as of July 24, 2020 unless otherwise noted.)

    • Melanoma cohort
      • Of the 5 evaluable melanoma patients (>1 scan), one had a confirmed partial response (PR) and two had stable disease on at least two consecutive scans.
      • The PR was achieved in a patient with metastatic urethral melanoma by week 20 of treatment, and a deepening of response was observed through week 39 of treatment. This patient's serum lactate dehydrogenase (LDH) levels, a known marker for treatment response in melanoma, normalized at week 5 of treatment and remained within the normal range throughout the treatment period. As of July 27, 2020, the patient had experienced a total tumor shrinkage of 39% and was continuing monotherapy treatment.
      • Since the July 24, 2020 data cut, one additional melanoma patient achieved a PR, awaiting a confirmatory scan. As of Sept. 1, 2020, this additional patient had experienced a total tumor shrinkage of 39% and was continuing monotherapy treatment.
      • With the observance of two PRs among the first 6 evaluable patients in the monotherapy melanoma cohort, the protocol-defined response criteria for expansion of this cohort was achieved, and the cohort will now enroll up to 20 additional patients for a total of up to 41 patients.

    ALKS 4230 in Combination with Pembrolizumab

    Data presented at ESMO from the combination stage of ARTISTRY-1 included data from patients in the PD-1/L1-approved, PD-1/L1-unapproved and monotherapy rollover cohorts (n=67 total). Patients representing more than 10 tumor types received ALKS 4230 3 µg/kg/day in combination with pembrolizumab. Responses were observed across multiple tumor types. (Data as of Aug. 7, 2020.)

    • Refractory ovarian cancer
      • Of the 13 evaluable patients (≥1 scan) with progressive, refractory ovarian cancer, 9 demonstrated stable disease on their first scan. Six of these 9 patients received a second scan by the data cutoff date, and 5 had stable disease or better. All 5 of these ovarian cancer patients were heavily pretreated and platinum-resistant, and each experienced tumor burden reduction with the combination of ALKS 4230 and pembrolizumab. Of these 5 patients:
        • One patient with platinum-resistant ovarian cancer achieved a complete response (CR) by week 45 of treatment, and a deepening of response was observed through week 81 of treatment. As of the data cut, this patient had a durable, confirmed CR and had remained on treatment for more than 18 months.
        • Two other patients with platinum-resistant ovarian cancer achieved PRs, one confirmed and one unconfirmed. As of the data cut, the patient with the confirmed PR demonstrated a deepening of response and had remained on treatment for more than 5 months.
    • Other tumor types
      • Additional PRs were achieved in multiple other tumor types across the PD-1/L1 approved and unapproved cohorts, including one patient with triple-negative breast cancer and two patients with esophageal cancer (one of which is awaiting confirmation). As of the data cut, these three patients had sustained PRs and continued on treatment.

    Safety and Tolerability

    (Data as of July 24, 2020 unless otherwise noted.)

    • The safety profile of ALKS 4230 in combination with pembrolizumab was generally consistent with the monotherapy profile. Based on the data available, ALKS 4230 in combination with pembrolizumab did not demonstrate any additive toxicity to that already established with pembrolizumab alone.
    • The most frequently observed treatment-emergent AEs in both the monotherapy and combination groups were transient fever and chills, all grade 1 or 2 in severity, which are consistent with anticipated effects of cytokine therapy. One patient in the monotherapy cohort had a grade 3 transient hypotension that was managed with fluids. There were no reports of vascular leak syndrome, which is a known AE associated with high-dose IL-2 treatment.
    • There were no deaths due to treatment-related AEs in the monotherapy cohorts. One death of a pancreatic cancer patient in the combination cohort, which occurred after the data cutoff, was due to inanition (starvation) and assessed as related to both study drugs.

    "The data presented at ESMO include early evidence of ALKS 4230's single-agent activity and its potential to deliver clinical benefit in multiple tumor types as a combination therapy," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "We're seeing increased momentum in enrollment trends across the broader ARTISTRY clinical development program, and we look forward to presenting our accumulating data for ALKS 4230 at future medical meetings."

    The mini oral presentation (#1027) titled, "ALKS 4230 Monotherapy and in Combination With Pembrolizumab in Patients With Refractory Solid Tumors (ARTISTRY-1)," is available on the ESMO website at www.esmo.org/meetings/esmo-virtual-congress-2020.

    Conference Call and Webcast

    Alkermes will host a webcast presentation and conference call with accompanying slides for analysts and investors on Friday, Sept. 18, 2020, at 8:30 a.m. ET (1:30 p.m. BST) to discuss the latest data from the ARTISTRY-1 clinical trial. The webcast will feature the lead study investigator, Dr. Ulka N. Vaishampayan, Professor of Internal Medicine, Division of Hematology/Oncology, at the University of Michigan, and members of Alkermes' management team. The webcast player may be accessed on the Investors section of Alkermes' website at www.alkermes.com. To participate in the question and answer session, please also dial in to the conference call, which 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 or by dialing +1 877-660-6853 for U.S. callers and +1 201-612-7415 for international callers, using replay access code 13708824. The conference call replay will be available from 11:30 a.m. ET (4:30 p.m. BST) on Friday, Sept. 18, 2020 through Friday, Sept. 25, 2020.

    About ALKS 4230

    ALKS 4230 is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

    About the ARTISTRY Clinical Development Program 

    ARTISTRY is an Alkermes-sponsored clinical development program evaluating ALKS 4230 in patients with advanced solid tumors.

    ARTISTRY-1 and ARTISTRY-2 are phase 1/2 studies evaluating the safety, tolerability, efficacy and pharmacokinetic and pharmacodynamic effects of ALKS 4230 in patients with refractory advanced solid tumors, in both monotherapy and combination settings with the PD-1 inhibitor pembrolizumab (KEYTRUDA®). In ARTISTRY-1, ALKS 4230 is administered as an intravenous infusion daily for five consecutive days.  In ARTISTRY-2, ALKS 4230 is administered subcutaneously and is being evaluated with once-weekly and once-every-three-week dosing schedules.

    ARTISTRY-3 is a phase 2 study evaluating the clinical and immunologic effects of ALKS 4230 monotherapy administered intravenously on the tumor microenvironment of a variety of advanced, malignant solid tumors.

    About Alkermes

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders, and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    Alkermes Note Regarding Forward-Looking Statements

    Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the potential therapeutic value of ALKS 4230 as a cancer immunotherapy when used as monotherapy or in combination across multiple tumor types; and the status of and plans for the clinical development of ALKS 4230, including enrollment trends across the ARTISTRY clinical development program, details of the ongoing ARTISTRY studies and the company's plans for presentation of data relating to the ARTISTRY development program. You are cautioned that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others, whether ALKS 4230, as a monotherapy or in combination, could be shown to be unsafe or ineffective; whether preclinical results and data from ongoing clinical studies for ALKS 4230—whether as a monotherapy or in combination—will be predictive of future or final results from such studies, results of future clinical studies or real-world results; whether future clinical trials or future stages of ongoing clinical trials for ALKS 4230, as a monotherapy or in combination, will be initiated or completed on time or at all; changes in the cost, scope and duration of, and clinical trial operations for, development activities for ALKS 4230, including changes relating to the impact of the novel coronavirus (COVID-19) pandemic; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2019, the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

    KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp.

    Alkermes Contacts:

    For Investors: Sandy Coombs, +1 781 609 6377

    For Media: Sourojit Bhowmick, Ph.D.+1 781 609 6397

    Alkermes plc Logo (PRNewsfoto/Alkermes plc)

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  18. DUBLIN, Sept. 14, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced the presentation of new real-world outcomes research and clinical data related to its psychiatry portfolio at the Psych Congress 2020 Virtual Experience, held Sept. 10-13, 2020. The company presented six posters, one of which focused on new outcomes research that analyzed treatment challenges of second-generation antipsychotics, such as weight gain and treatment interruptions, in patients living with schizophrenia or bipolar I disorder.

    The recent outcomes research used data from the OM1 Real-World Data Cloud1 to assess patterns of antipsychotic-associated weight gain and treatment interruptions (i.e., switching or discontinuation) among patients with schizophrenia…

    DUBLIN, Sept. 14, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced the presentation of new real-world outcomes research and clinical data related to its psychiatry portfolio at the Psych Congress 2020 Virtual Experience, held Sept. 10-13, 2020. The company presented six posters, one of which focused on new outcomes research that analyzed treatment challenges of second-generation antipsychotics, such as weight gain and treatment interruptions, in patients living with schizophrenia or bipolar I disorder.

    The recent outcomes research used data from the OM1 Real-World Data Cloud1 to assess patterns of antipsychotic-associated weight gain and treatment interruptions (i.e., switching or discontinuation) among patients with schizophrenia or bipolar I disorder who initiated oral second-generation antipsychotics of moderate-to-high weight gain risk.2 A total of 8,174 patients with schizophrenia and 9,142 patients with bipolar I disorder were included in this retrospective analysis, with an average age of 57 years and 48 years, respectively.

    "Real-world data is important in understanding the impact that certain treatment side effects may have on a patient," said Linda Stalters, MSN, APRN(ret), Founder and Director of Health Affairs at Schizophrenia and Related Disorders Alliance of America (SARDAA). "Schizophrenia and bipolar I disorder are lifelong diseases that may require long-term treatment, so it is important to take a holistic approach when considering a patient's treatment journey."

    "We were pleased to share new research at this year's virtual Psych Congress, underscoring Alkermes' commitment to addressing the challenges faced by those living with serious mental illness," said Amy O'Sullivan, Vice President, Health Economics and Outcomes Research at Alkermes. "The outcomes research findings offer insight into the weight gain and treatment interruption patterns that may occur in patients with schizophrenia and bipolar I disorder, providing us with a broader understanding of the potential needs of these patient communities."

    In addition to the outcomes data, Alkermes presented several posters related to the company's psychiatry products and development candidates, ARISTADA® (aripiprazole lauroxil), ARISTADA INITIO® (aripiprazole lauroxil) and ALKS 3831 (olanzapine/samidorphan). The full list of Alkermes' presentations at Psych Congress is as follows:

    • Poster #101: "A Combination of Olanzapine and Samidorphan in Adults With Schizophrenia and Bipolar I Disorder: Overview of Clinical Data"
    • Poster #135: "Disease Prevalence, Comorbid Conditions, and Medication Utilization Among Patients with Schizophrenia in the United States"
    • Poster #185: "Phase 3 Safety and Tolerability Results of the Combination of Olanzapine and Samidorphan in Patients With Schizophrenia: The 1-Year ENLIGHTEN-2-Extension"
    • Poster #192: "Qualitative Clinical Trial Exit Interviews Evaluating Treatment Benefit, Burden, and Satisfaction in Patients With Schizophrenia"
    • Poster #200: "Safety and Tolerability of Aripiprazole Lauroxil 2-Month Formulation With 1-Day Initiation for Treatment of Schizophrenia in the ALPINE Study"
    • Poster #214: "Weight Gain and Treatment Interruptions with Second-Generation Oral Antipsychotics: Analysis of Real-World Data Among Patients with Schizophrenia or Bipolar I Disorder"

    For more information, please visit the Psych Congress website at https://national.psychcongress.com.

    About ALKS 3831

    ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. ALKS 3831 is composed of samidorphan, a novel, new molecular entity, co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.

    About ARISTADA®

    ARISTADA is an injectable atypical antipsychotic approved in four doses and three dosing durations for the treatment of schizophrenia (441 mg, 662 mg or 882 mg monthly, 882 mg once every six weeks and 1064 mg once every two months). Once in the body, ARISTADA converts to aripiprazole.

    About ARISTADA INITIO®

    ARISTADA INITIO, in combination with a single 30 mg dose of oral aripiprazole, can be used to initiate onto any dose of ARISTADA. The first ARISTADA dose may be administered on the same day as the ARISTADA INITIO regimen or up to 10 days thereafter.

    INDICATION and IMPORTANT SAFETY INFORMATION for ARISTADA INITIO® (aripiprazole lauroxil) and ARISTADA® (aripiprazole lauroxil) extended-release injectable suspension, for intramuscular use

    INDICATION

    ARISTADA INITIO, in combination with oral aripiprazole, is indicated for the initiation of ARISTADA when used for the treatment of schizophrenia in adults.

    ARISTADA is indicated for the treatment of schizophrenia in adults.

    IMPORTANT SAFETY INFORMATION

    WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS



    Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ARISTADA INITIO and ARISTADA are not approved for the treatment of patients with dementia-related psychosis. 

    Contraindication: Known hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis.

    Cerebrovascular Adverse Reactions, Including Stroke: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack), including fatalities, have been reported in placebo-controlled trials of elderly patients with dementia-related psychosis treated with risperidone, aripiprazole, and olanzapine. ARISTADA INITIO and ARISTADA are not approved for the treatment of patients with dementia-related psychosis. 

    Potential for Dosing and Medication Errors: Medication errors, including substitution and dispensing errors, between ARISTADA INITIO and ARISTADA could occur.  ARISTADA INITIO is intended for single administration in contrast to ARISTADA which is administered monthly, every 6 weeks, or every 8 weeks. Do not substitute ARISTADA INITIO for ARISTADA because of differing pharmacokinetic profiles.

    Neuroleptic Malignant Syndrome (NMS): A potentially fatal symptom complex may occur with administration of antipsychotic drugs, including ARISTADA INITIO and ARISTADA. Clinical manifestations of NMS include hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. The management of NMS should include: 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy; 2) intensive symptomatic treatment and medical monitoring; and 3) treatment of any concomitant serious medical problems for which specific treatments are available. 

    Tardive Dyskinesia (TD): The risk of developing TD (a syndrome of abnormal, involuntary movements) and the potential for it to become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic increase. The syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. Prescribing antipsychotics should be consistent with the need to minimize TD. Discontinue ARISTADA if clinically appropriate. TD may remit, partially or completely, if antipsychotic treatment is withdrawn.

    Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that include: 

    • Hyperglycemia/Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis, coma, or death, has been reported in patients treated with atypical antipsychotics. There have been reports of hyperglycemia in patients treated with oral aripiprazole. Patients with diabetes should be regularly monitored for worsening of glucose control; those with risk factors for diabetes should undergo baseline and periodic fasting blood glucose testing. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia, including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients require continuation of antidiabetic treatment despite discontinuation of the suspect drug.
    • Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.
    • Weight Gain: Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.

    Pathological Gambling and Other Compulsive Behaviors: Compulsive or uncontrollable urges to gamble have been reported with use of aripiprazole. Other compulsive urges less frequently reported include sexual urges, shopping, binge eating and other impulsive or compulsive behaviors which may result in harm for the patient and others if not recognized. Closely monitor patients and consider dose reduction or stopping aripiprazole if a patient develops such urges.

    Orthostatic Hypotension: Aripiprazole may cause orthostatic hypotension which can be associated with dizziness, lightheadedness, and tachycardia. Monitor heart rate and blood pressure, and warn patients with known cardiovascular or cerebrovascular disease and risk of dehydration and syncope.

    Falls: Antipsychotics including ARISTADA INITIO and ARISTADA may cause somnolence, postural hypotension or motor and sensory instability which may lead to falls and subsequent injury.  Upon initiating treatment and recurrently, complete fall risk assessments as appropriate.

    Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia, neutropenia and agranulocytosis have been reported with antipsychotics. Monitor complete blood count in patients with pre-existing low white blood cell count (WBC)/absolute neutrophil count or history of drug-induced leukopenia/neutropenia. Discontinue ARISTADA INITIO and/or ARISTADA at the first sign of a clinically significant decline in WBC and in severely neutropenic patients.

    Seizures: Use with caution in patients with a history of seizures or with conditions that lower the seizure threshold. 

    Potential for Cognitive and Motor Impairment: ARISTADA INITIO and ARISTADA may impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are certain therapy with ARISTADA INITIO and/or ARISTADA does not affect them adversely.

    Body Temperature Regulation: Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic agents. Advise patients regarding appropriate care in avoiding overheating and dehydration. Appropriate care is advised for patients who may exercise strenuously, may be exposed to extreme heat, receive concomitant medication with anticholinergic activity, or are subject to dehydration.

    Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use; use caution in patients at risk for aspiration pneumonia.

    Concomitant Medication: ARISTADA INITIO is only available at a single strength as a single-dose pre-filled syringe, so dosage adjustments are not possible. Avoid use in patients who are known CYP2D6 poor metabolizers or taking strong CYP3A4 inhibitors, strong CYP2D6 inhibitors, or strong CYP3A4 inducers, antihypertensive drugs or benzodiazepines.   

    Depending on the ARISTADA dose, adjustments may be recommended if patients are 1) known as CYP2D6 poor metabolizers and/or 2) taking strong CYP3A4 inhibitors, strong CYP2D6 inhibitors, or strong CYP3A4 inducers for greater than 2 weeks.  Avoid use of ARISTADA 662mg, 882mg, or 1064 mg for patients taking both strong CYP3A4 inhibitors and strong CYP2D6 Inhibitors. (See Table 4 in the ARISTADA full Prescribing Information)

    Commonly Observed Adverse Reactions: In pharmacokinetic studies the safety profile of ARISTADA INITIO was generally consistent with that observed for ARISTADA. The most common adverse reaction (≥5% incidence and at least twice the rate of placebo reported by patients treated with ARISTADA 441mg and 882 mg monthly) was akathisia. 

    Injection-Site Reactions: In pharmacokinetic studies evaluating ARISTADA INITIO, the incidences of injection site reactions with ARISTADA INITIO were similar to the incidence observed with ARISTADA.  Injection-site reactions were reported by 4%, 5%, and 2% of patients treated with 441 mg ARISTADA (monthly), 882 mg ARISTADA (monthly), and placebo, respectively. Most of these were injection-site pain and associated with the first injection and decreased with each subsequent injection. Other injection-site reactions (induration, swelling, and redness) occurred at less than 1%.

    Dystonia: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first days of treatment and at low doses.

    Pregnancy/Nursing: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Advise patients to notify their healthcare provider of a known or suspected pregnancy. Inform patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ARISTADA INITIO and/or ARISTADA during pregnancy. Aripiprazole is present in human breast milk. The benefits of breastfeeding should be considered along with the mother's clinical need for ARISTADA INITIO and/or ARISTADA and any potential adverse effects on the infant from ARISTADA INITIO and/or ARISTADA or from the underlying maternal condition.

    Please see full Prescribing Information, including Boxed Warning for ARISTADA INITIO and ARISTADA.

    About Alkermes

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

     

    ARISTADA® and ARISTADA INITIO® are registered trademarks of Alkermes Pharma Ireland Limited.

    1 The OM1 Real-World Data Cloud (OM1, Inc.; Boston, MA) includes de-identified patient-level health care claims and electronic medical records (EMRs) linked for >50 million patients using a proprietary method with patient-specific identifiers.

    2 Oral second-generation antipsychotics of moderate-to-high weight gain risk included in the retrospective analysis were: Olanzapine, Clozapine (SZ only), Iloperidone (SZ only), Paliperidone (SZ only), Risperidone, Quetiapine, Olanzapine/fluoxetine combination (BD-1 only)

     

    Alkermes Contacts:

    For Investors: Sandy Coombs,    +1 781 609 6377

    For Media:      Marisa Borgasano,  +1 781 609 6659

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  19. DUBLIN, Sept. 9, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) announced today that that its Chief Executive Officer, Richard Pops, will participate in a fireside chat at the Cantor Virtual Global Healthcare Conference on Wednesday, Sept. 16, 2020 at 10:40 a.m. ET (3:40 p.m. BST). The webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

    About Alkermes plc

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative…

    DUBLIN, Sept. 9, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) announced today that that its Chief Executive Officer, Richard Pops, will participate in a fireside chat at the Cantor Virtual Global Healthcare Conference on Wednesday, Sept. 16, 2020 at 10:40 a.m. ET (3:40 p.m. BST). The webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

    About Alkermes plc

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    Contact:

    Alex Braun

    Investor Relations

    +1 781 296 8493

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  20. DUBLIN, Sept. 8, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that it will present new clinical data related to ALKS 4230, its investigational engineered interleukin-2 (IL-2) variant immunotherapy, at the European Society for Medical Oncology (ESMO) Virtual Congress, taking place Sept. 18-21, 2020. Safety and anti-tumor efficacy data from the ongoing phase 1/2 ARTISTRY-1 study, evaluating ALKS 4230 as monotherapy and in combination with pembrolizumab in patients with refractory solid tumors, will be shared in a mini oral presentation. The company will host an accompanying webcast and conference call at 8:30 a.m. ET on Friday, Sept. 18, 2020.

    "The ESMO Virtual Congress serves as an important forum to share the latest data on…

    DUBLIN, Sept. 8, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that it will present new clinical data related to ALKS 4230, its investigational engineered interleukin-2 (IL-2) variant immunotherapy, at the European Society for Medical Oncology (ESMO) Virtual Congress, taking place Sept. 18-21, 2020. Safety and anti-tumor efficacy data from the ongoing phase 1/2 ARTISTRY-1 study, evaluating ALKS 4230 as monotherapy and in combination with pembrolizumab in patients with refractory solid tumors, will be shared in a mini oral presentation. The company will host an accompanying webcast and conference call at 8:30 a.m. ET on Friday, Sept. 18, 2020.

    "The ESMO Virtual Congress serves as an important forum to share the latest data on our immunotherapy candidate, ALKS 4230, with the global oncology community," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "We look forward to sharing new safety and efficacy data from our ARTISTRY-1 clinical trial, where we are evaluating ALKS 4230 as a monotherapy and combination therapy to treat a variety of tumor types in patients with tumors that are refractory to currently established treatments."

    A mini oral presentation (#1027) titled, "ALKS 4230 Monotherapy and in Combination With Pembrolizumab in Patients With Refractory Solid Tumors (ARTISTRY-1)," to be presented by Ulka N. Vaishampayan, M.D., Professor, Internal Medicine, Division of Hematology/Oncology, University of Michigan, will be available on the ESMO website at https://www.esmo.org/meetings/esmo-virtual-congress-2020.

    Conference Call and Webcast

    Alkermes will host a webcast presentation and conference call with accompanying slides for analysts and investors on Friday, Sept. 18, 2020, at 8:30 a.m. ET (1:30 p.m. BST) to discuss the latest data from the ARTISTRY-1 clinical trial. The webcast will feature the lead study investigator, Dr. Ulka N. Vaishampayan, Professor of Internal Medicine, Division of Hematology/Oncology, at the University of Michigan, and members of Alkermes' management team. The webcast player may be accessed on the Investors section of Alkermes' website at www.alkermes.com. To participate in the question and answer session, please also dial in to the conference call, which 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 or by dialing +1 877-660-6853 for U.S. callers and +1 201-612-7415 for international callers, using replay access code 13708824. The conference call replay will be available from 11:30 a.m. ET (4:30 p.m. BST) on Friday, Sept. 18, 2020 through Friday, Sept. 25, 2020.

    About ALKS 4230

    ALKS 4230 is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

    About Alkermes

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    Alkermes Contacts:

    For Investors: Sandy Coombs +1 781 609 6377

    For Media: Sourojit Bhowmick, Ph.D. +1 781 609 6397

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  21. DUBLIN, Aug. 21, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that a joint meeting of the U.S. Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to review the New Drug Application (NDA) for ALKS 3831 (olanzapine/samidorphan) has been tentatively scheduled for Oct. 9, 2020. ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. The Prescription Drug User Fee Act (PDUFA) action date for the ALKS 3831 NDA is Nov. 15, 2020.

    It is expected that the advisory committee panel will review the efficacy…

    DUBLIN, Aug. 21, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that a joint meeting of the U.S. Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to review the New Drug Application (NDA) for ALKS 3831 (olanzapine/samidorphan) has been tentatively scheduled for Oct. 9, 2020. ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. The Prescription Drug User Fee Act (PDUFA) action date for the ALKS 3831 NDA is Nov. 15, 2020.

    It is expected that the advisory committee panel will review the efficacy, safety, and benefit-risk profile of ALKS 3831 for the proposed indications of schizophrenia and bipolar I disorder. As announced previously, the company expects the advisory panel to focus on the clinical meaningfulness of ALKS 3831's attenuation of olanzapine-associated weight gain, including the magnitude of weight effect and the impact of ALKS 3831 on laboratory-based metabolic parameters. Since that time, the company has learned that the panel will also discuss certain potential clinical risks related to the interaction of ALKS 3831, which includes samidorphan, an opioid receptor antagonist, and opioids in the intended patient populations.

    "We look forward to engaging with members of the joint advisory committee panel in a robust discussion of the clinical evidence for ALKS 3831," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "For adults living with schizophrenia or bipolar I disorder, populations already prone to shortened life expectancy and cardiovascular comorbidities, the significant weight gain often associated with olanzapine can represent a major clinical liability. Patients and healthcare providers may benefit from additional treatment options that help manage disease symptoms while mitigating weight gain. We are committed to bringing this potential new medicine to adults living with schizophrenia or bipolar I disorder."  

    The NDA submission and clinical development program for ALKS 3831 are supported by data from 27 clinical studies, including 18 studies evaluating ALKS 3831 and nine studies evaluating samidorphan alone. Throughout the clinical development program, ALKS 3831 showed evidence of antipsychotic efficacy, safety and tolerability, including attenuation of olanzapine-associated weight gain.

    About ALKS 3831

    ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. ALKS 3831 is composed of samidorphan, a novel, new molecular entity, co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.

    About Schizophrenia 

    Schizophrenia is a serious brain disorder marked by positive symptoms (hallucinations and delusions, disorganized speech and thoughts, and agitated or repeated movements) and negative symptoms (depression, blunted emotions and social withdrawal).1 An estimated 2.4 million American adults have schizophrenia,2 with men and women affected equally.

    About Bipolar I Disorder

    Bipolar disorder is a brain disorder that causes shifts in a person's mood, energy and ability to function. Patients with this brain disorder may experience debilitating mood shifts from extreme highs (mania) to extreme lows (depression). Bipolar I disorder is characterized by the occurrence of at least one manic episode, with or without the occurrence of a major depressive episode, and affects approximately one percent of the adult population in the United States in any given year.3

    About Alkermes plc

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    Note Regarding Forward-Looking Statements

    Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the potential therapeutic and commercial value of ALKS 3831 for the treatment of adults with schizophrenia and the treatment of adults with bipolar I disorder; the company's current expectations regarding the timing and substance of the FDA's joint advisory committee meeting to review the ALKS 3831 NDA, including the joint advisory committees' consideration of the clinical meaningfulness of ALKS 3831's attenuation of olanzapine-associated weight gain, including the magnitude of weight effect and the impact of ALKS 3831 on laboratory-based metabolic parameters, and potential clinical risks related to the interaction of ALKS 3831 with opioids in the intended patient populations; and the company's additional expectations regarding the ALKS 3831 NDA, including the FDA's PDUFA target action date for the NDA and the adequacy of the data contained in the NDA to serve as the basis for approval of ALKS 3831 for the treatment of adults with schizophrenia and the treatment of adults with bipolar I disorder. The company cautions that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: unanticipated impacts of the COVID-19 pandemic on the company's operations, plans and prospects and on the operations of the regulatory agencies involved in the review and potential approval of ALKS 3831; potential changes in the cost, scope and duration of the ALKS 3831 development and regulatory program; whether ALKS 3831 could be shown ineffective or unsafe during clinical studies; data from the ALKS 3831 clinical development program may be interpreted by the FDA in different ways than the company interprets it; the FDA may not agree with the company's regulatory approval strategies or components of its NDA filing for ALKS 3831, including the company's clinical trial designs, conduct and methodologies, manufacturing processes and facilities; the FDA's determination as to the clinical meaningfulness of the ALKS 3831 weight data, including the effects of ALKS 3831 on metabolic parameters; the joint advisory committees' or FDA's views of impact on the risk/benefit profile of ALKS 3831 of the interaction of ALKS 3831 with opioids in the intended patient populations; and the adequacy of the preclinical and clinical results of the ALKS 3831 studies and the PK bridging data and other information included in the ALKS 3831 NDA to meet the FDA's requirements for approval for the proposed schizophrenia and bipolar I disorder indications; if approved, whether ALKS 3831 will be commercialized successfully; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2019, the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission ("SEC"), which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

    1American Psychiatric Association. Schizophrenia Spectrum and Other Psychiatric Disorders. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Washington, DC: American Psychiatric Publishing; 2013.

    National Institutes of Health. Schizophrenia. Accessed on Aug. 20, 2020 from https://archives.nih.gov/asites/report/09-09-2019/report.nih.gov/nihfactsheets/Pdfs/Schizophrenia(NIMH).pdf.

    Merikangas et al. Lifetime and 12-Month Prevalence of Bipolar Spectrum Disorder in the National Comorbidity Survey Replication. Arch Gen Psychiatry, 2007 May; 64(5): 543–552. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1931566/

    Alkermes Contacts:

    For Investors:

    Sandy Coombs

    +1 781 609 6377

    For Media:

    Eva Stroynowski

    +1 781 609 6823

     

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  22. DUBLIN, Aug. 19, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced the initiation of ARTISTRY-3, a new phase 2 study to evaluate the clinical and immunologic effects of ALKS 4230 monotherapy on the tumor microenvironment of a variety of advanced, malignant solid tumors. ALKS 4230, a novel cytokine, is an investigational, engineered fusion protein designed to selectively expand tumor-killing immune cells while avoiding the interleukin-2 (IL-2)-induced activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex.

    "Early clinical data from our ARTISTRY program showed that ALKS 4230 selectively expanded cancer-fighting immune cells in the periphery, with negligible effects on regulatory…

    DUBLIN, Aug. 19, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced the initiation of ARTISTRY-3, a new phase 2 study to evaluate the clinical and immunologic effects of ALKS 4230 monotherapy on the tumor microenvironment of a variety of advanced, malignant solid tumors. ALKS 4230, a novel cytokine, is an investigational, engineered fusion protein designed to selectively expand tumor-killing immune cells while avoiding the interleukin-2 (IL-2)-induced activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex.

    "Early clinical data from our ARTISTRY program showed that ALKS 4230 selectively expanded cancer-fighting immune cells in the periphery, with negligible effects on regulatory T cells (Tregs)," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "Data from the ARTISTRY-3 clinical trial will provide a deeper understanding of the effects of ALKS 4230 on immunologic activity in the tumor microenvironment across a variety of tumor types. Findings from this trial may help us answer important mechanistic questions and identify the tumor types for which ALKS 4230 could offer the most clinical benefit, thereby helping to inform a potential registration strategy." 

    This single-center, open-label study will evaluate treatment-emergent changes in the tumor microenvironment and peripheral blood immunophenotypes, as well as the safety, tolerability, and pharmacokinetic profile of ALKS 4230 (6µg/kg) dosed intravenously, as lead-in monotherapy followed by combination with the anti-PD-1 therapy KEYTRUDA® (pembrolizumab), in patients with select advanced malignant solid tumors. Paired tumor biopsies will be collected pre–treatment and following the monotherapy and combination phases to evaluate the effects of ALKS 4230 on the immune cell repertoire, including changes in density and ratio of immune cells, within the tumor microenvironment. The study will also assess clinical anti-tumor activity (overall response rate and duration of response) of ALKS 4230 as one of its secondary objectives.

    ARTISTRY-3 is the fourth clinical trial evaluating ALKS 4230 as a novel immuno-oncology candidate.  ARTISTRY-1 and ARTISTRY-2 are ongoing, phase 1/2 studies evaluating ALKS 4230 as a monotherapy and in combination with pembrolizumab. ARTISTRY-1 and ARTISTRY-2 are evaluating intravenous and subcutaneous administration of ALKS 4230, respectively. ION-01 is an ongoing, phase 2 multi-site trial, designed to estimate the response rate to ALKS 4230 in combination with pembrolizumab in patients with advanced or recurrent head and neck squamous cell cancer who did not achieve complete remission with an anti-PD-(L)1 antibody treatment.

    About ALKS 4230

    ALKS 4230 is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

    About the ARTISTRY Clinical Development Program 

    ARTISTRY is an Alkermes-sponsored clinical development program evaluating ALKS 4230 in patients with advanced solid tumors.

    ARTISTRY-1 and ARTISTRY-2 are phase 1/2 studies evaluating the safety, tolerability, efficacy and pharmacokinetic and pharmacodynamic effects of ALKS 4230 in patients with refractory advanced solid tumors, in both monotherapy and combination settings with the PD-1 inhibitor KEYTRUDA® (pembrolizumab). In ARTISTRY-1, ALKS 4230 is administered as an intravenous infusion daily for five consecutive days.  In ARTISTRY-2, ALKS 4230 is administered subcutaneously and is being evaluated with once-weekly and once-every-three-week dosing schedules.

    ARTISTRY-3 will evaluate the clinical and immunologic activity of intravenous ALKS 4230 monotherapy on tumor microenvironment in advanced solid tumor patients.

    About Alkermes

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders, and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    Alkermes Note Regarding Forward-Looking Statements

    Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the potential therapeutic value of ALKS 4230 as a cancer immunotherapy when used as monotherapy or in combination; and the clinical trial design for, and potential findings from, the ARTISTRY-3 study. You are cautioned that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others, whether ALKS 4230, as a monotherapy or in combination, could be shown to be unsafe or ineffective; whether preclinical and preliminary, interim or final clinical results for ALKS 4230—whether as a monotherapy or in combination with pembrolizumab—will be predictive of future data from the same studies, results of future clinical studies or real-world results; whether future clinical trials or future stages of ongoing clinical trials for ALKS 4230, as a monotherapy or in combination, will be initiated or completed on time or at all; changes in the cost, scope and duration of, and clinical trial operations for, development activities for ALKS 4230, including changes relating to the novel coronavirus (COVID-19); and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2019, the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

    KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp.

    Alkermes Contacts:

    For Investors: Sandy Coombs, +1 781 609 6377

    For Media: Sourojit Bhowmick, Ph.D. +1 781 609 6397

    Alkermes plc Logo (PRNewsfoto/Alkermes plc)

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  23. DUBLIN, Aug. 17, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced the publication of results from the phase 3 ENLIGHTEN-2 clinical trial of ALKS 3831 (olanzapine/samidorphan) in the peer-reviewed publication, American Journal of Psychiatry. ENLIGHTEN-2 was a six-month study evaluating the weight gain profile of ALKS 3831 compared to olanzapine in 561 patients with stable schizophrenia. Positive topline data from the ENLIGHTEN-2 study were first reported in November 2018.

    The full manuscript, titled "Effects of Olanzapine Combined With Samidorphan on Weight Gain in Schizophrenia: A 24-Week Phase 3 Study," is now accessible online. External publication authors include: René Kahn, M.D., Ph.D., Icahn School of Medicine at Mount Sinai…

    DUBLIN, Aug. 17, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced the publication of results from the phase 3 ENLIGHTEN-2 clinical trial of ALKS 3831 (olanzapine/samidorphan) in the peer-reviewed publication, American Journal of Psychiatry. ENLIGHTEN-2 was a six-month study evaluating the weight gain profile of ALKS 3831 compared to olanzapine in 561 patients with stable schizophrenia. Positive topline data from the ENLIGHTEN-2 study were first reported in November 2018.

    The full manuscript, titled "Effects of Olanzapine Combined With Samidorphan on Weight Gain in Schizophrenia: A 24-Week Phase 3 Study," is now accessible online. External publication authors include: René Kahn, M.D., Ph.D., Icahn School of Medicine at Mount Sinai (corresponding author); Christoph Correll, M.D., Barbara and Donald Zucker School of Medicine at Hofstra/Northwell; and John Newcomer, M.D., Washington University School of Medicine in St. Louis.

    "The publication of the ENLIGHTEN-2 data in a peer-reviewed journal represents an important milestone for the ALKS 3831 development program and demonstrates Alkermes' dedication to expanding the body of research on schizophrenia treatment," said Craig Hopkinson, M.D., Executive Vice President, Research & Development and Chief Medical Officer at Alkermes. "Alkermes remains committed to developing and bringing to market potential new medicines that may help people living with serious mental illness and their families."

    ENLIGHTEN-2 is the second of two key studies included in the ALKS 3831 ENLIGHTEN clinical development program. ENLIGHTEN-1, the first phase 3 study, evaluated the efficacy, safety and tolerability of ALKS 3831 compared to placebo in patients experiencing an acute exacerbation of schizophrenia. Positive topline data from the ENLIGHTEN-1 study were first reported in June 2017 and full results were later published in the peer-reviewed publication, Journal of Clinical Psychiatry.1

    A New Drug Application (NDA) for ALKS 3831 for the treatment of adults with schizophrenia and the treatment of adults with bipolar I disorder is currently under U.S. Food and Drug Administration (FDA) review, with a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 15, 2020.

    About ALKS 3831

    ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. ALKS 3831 is composed of samidorphan, a novel, new molecular entity, co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.

    About Schizophrenia  

    Schizophrenia is a serious brain disorder marked by positive symptoms (hallucinations and delusions, disorganized speech and thoughts, and agitated or repeated movements) and negative symptoms (depression, blunted emotions and social withdrawal).2 An estimated 2.4 million American adults have schizophrenia,3 with men and women affected equally. 

    About Bipolar I Disorder 

    Bipolar disorder is a brain disorder that causes unusual shifts in a person's mood, energy and ability to function. Patients with this brain disorder may experience debilitating mood shifts from extreme highs (mania) to extreme lows (depression). Bipolar I disorder is characterized by the occurrence of at least one manic episode with or without the occurrence of a major depressive episode, and affects approximately one percent of the adult population in the United States in any given year.4

    About Alkermes plc

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    Note Regarding Forward-Looking Statements

    Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company's commitment to developing and bringing to market new therapeutic options that may help people living with serious mental illness and their families; the potential therapeutic and commercial value of ALKS 3831 for the treatment of adults with schizophrenia and the treatment of adults with bipolar I disorder; and the expected timing of the FDA's PDUFA target action date for the NDA for ALKS 3831. The company cautions that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: unanticipated impacts of the COVID-19 pandemic on the company's business operations, plans and prospects; whether the preclinical and clinical results of the ALKS 3831 studies and the PK bridging data contained in the NDA will meet the regulatory requirements for approval by the FDA for the proposed schizophrenia and bipolar I disorder indications; potential changes in the cost, scope and duration of the ALKS 3831 development and regulatory program; whether ALKS 3831 could be shown ineffective or unsafe during clinical studies; whether the NDA for ALKS 3831 will be approved by the FDA and, if approved, whether ALKS 3831 will be commercialized successfully; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2019, the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

    1 Potkin et al. Efficacy and Safety of a Combination of Olanzapine and Samidorphan in Adult Patients With an Acute Exacerbation of Schizophrenia: Outcomes From the Randomized, Phase 3 ENLIGHTEN-1 Study. J Clin Psych, 2020;81(2):19m12769. https://doi.org/10.4088/JCP.19m12769

    2American Psychiatric Association. Schizophrenia Spectrum and Other Psychiatric Disorders. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Washington, DC: American Psychiatric Publishing; 2013.

    3 National Institutes of Health. Schizophrenia. Accessed on August 14, 2020 from https://archives.nih.gov/asites/report/09-09-2019/report.nih.gov/nihfactsheets/Pdfs/Schizophrenia(NIMH).pdf.

    4 Merikangas et al. Lifetime and 12-Month Prevalence of Bipolar Spectrum Disorder in the National Comorbidity Survey Replication. Arch Gen Psychiatry, 2007 May; 64(5): 543–552.  http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1931566/

    Alkermes Contacts:





    For Investors:

    Sandy Coombs,

    +1 781 609 6377

    For Media:

    Marisa Borgasano,

    +1 781 609 6659

     

    Alkermes plc Logo (PRNewsfoto/Alkermes plc)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/american-journal-of-psychiatry-publishes-data-from-alkermes-phase-3-enlighten-2-weight-study-of-alks-3831-in-patients-with-schizophrenia-301112717.html

    SOURCE Alkermes plc

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  24. DUBLIN, July 29, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today reported financial results for the second quarter of 2020 and provided updated financial expectations for full-year 2020. The company had previously withdrawn its 2020 financial expectations due to uncertainties regarding the impact of the COVID-19 pandemic on its business.

    "During the second quarter, we adapted in response to the changing conditions in a complex environment. As we enter the second half of 2020, we are focused on three strategic imperatives. The first is commercial execution, as we drive to maximize the opportunities for ARISTADA® and VIVITROL® and prepare for the potential launch of ALKS 3831. The second is aggressive development of our pipeline programs…

    DUBLIN, July 29, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today reported financial results for the second quarter of 2020 and provided updated financial expectations for full-year 2020. The company had previously withdrawn its 2020 financial expectations due to uncertainties regarding the impact of the COVID-19 pandemic on its business.

    "During the second quarter, we adapted in response to the changing conditions in a complex environment. As we enter the second half of 2020, we are focused on three strategic imperatives. The first is commercial execution, as we drive to maximize the opportunities for ARISTADA® and VIVITROL® and prepare for the potential launch of ALKS 3831. The second is aggressive development of our pipeline programs, focusing on high-value opportunities that we believe have the potential to address patient needs and drive significant value in the near- and long-term. ALKS 4230, our lead oncology candidate, is the most prominent of these opportunities. The third is efficient management of our operating structure, with a focus on rigorous expense management and careful prioritization of our investments," said Richard Pops, Chief Executive Officer of Alkermes.

    "We distinguish ourselves from other biopharmaceutical companies through our efforts in serious mental illness and addiction — chronic, highly prevalent conditions that affect millions of people and represent some of the most challenging public health issues of our time. We have built our organization with purpose and invested in specialized commercial capabilities to navigate fragmented treatment systems as we help address the complex challenges that patients with these diseases face," continued Mr. Pops. "As the nation's response to COVID-19 continues, it is critical that we work to mitigate the pandemic's secondary impacts related to social isolation, economic hardship and anxiety. For many patients struggling with serious mental illness and addiction, the current environment has amplified the barriers to treatment that Alkermes has worked for many years to address. We believe it is our responsibility to help ensure that the treatment system continues to function for these patients." 

    Quarter Ended June 30, 2020 Financial Highlights

    • Total revenues for the quarter were $247.5 million, compared to $279.9 million for the same period in the prior year.
    • Net loss according to generally accepted accounting principles in the U.S. (GAAP) was $29.4 million for the quarter, or a GAAP net loss per share of $0.19. This compared to GAAP net loss of $42.0 million, or a GAAP net loss per share of $0.27, for the same period in the prior year.
    • Non-GAAP net income was $8.9 million for the quarter, or a non-GAAP basic and diluted earnings per share of $0.06. This compared to non-GAAP net income of $13.7 million, or a non-GAAP basic and diluted earnings per share of $0.09, for the same period in the prior year.

    Quarter Ended June 30, 2020 Financial Results

    Revenues

    • Net sales of proprietary products were $130.4 million, compared to $136.6 million for the same period in the prior year.
      • Net sales of VIVITROL were $71.6 million, compared to $88.2 million for the same period in the prior year, representing a decrease of approximately 19%, driven primarily by a decline in new patient starts and more restricted access to healthcare providers that resulted from COVID-19-related disruptions.
      • Net sales of ARISTADAwere $58.8 million, compared to $48.4 million for the same period in the prior year, representing an increase of approximately 21% driven primarily by increased breadth of the ARISTADA provider base and growth of the ARISTADA two-month dose.
    • Manufacturing and royalty revenues were $116.5 million, compared to $127.9 million for the same period in the prior year.
      • Manufacturing and royalty revenues from RISPERDAL CONSTA®, INVEGA SUSTENNA®/XEPLION® and INVEGA TRINZA®/TREVICTA® were $83.1 million, compared to $91.9 million for the same period in the prior year, primarily driven by a decrease in manufacturing and royalty revenues related to RISPERDAL CONSTA.

    Costs and Expenses

    • Total operating expenses were $281.2 million, compared to $315.8 million for the same period in the prior year.
      • Research and Development (R&D) expenses were $94.2 million, compared to $104.4 million for the same period in the prior year.
      • Selling, General and Administrative (SG&A) expenses were $132.0 million, compared to $155.1 million for the same period in the prior year.

    Balance Sheet

    • At June 30, 2020, Alkermes recorded cash, cash equivalents and total investments of $539.6 million, compared to $549.7 million at March 31, 2020. Cash on hand at June 30, 2020 significantly exceeded the company's total debt outstanding of $276.1 million under its term loan, which matures in March 2023.

    "Our second quarter results reflect solid execution across the business. The performance of the ARISTADA product family, together with disciplined management of expenses, partially offset the negative impact on VIVITROL net sales that resulted from COVID-19-related decreases in patient visits to healthcare providers and treatment centers. With increased visibility into the expected impact of COVID-19 on our commercial portfolio, today we are issuing financial expectations for 2020 that reflect current trends and underscore our commitment to driving non-GAAP profitability," commented James Frates, Chief Financial Officer of Alkermes. "Over the past five years, we have grown our topline while investing in the future growth drivers of our business. Directly as a result of those investments, we established VIVITROL as an important therapeutic option for patients with opioid and alcohol dependence; we secured FDA approvals for the ARISTADA product family; we developed ALKS 3831 and submitted a New Drug Application for schizophrenia and bipolar I disorder; we built commercial psychiatry capabilities that support the growth of ARISTADA and which are also fully leverageable for ALKS 3831; we successfully developed VUMERITY® and entered into a commercial collaboration that will provide 100% gross margin royalty revenues from net sales; we advanced development of ALKS 4230 while retaining optionality for strategic collaboration; and, we acquired a platform of histone deacetylase (HDAC) inhibitors that we believe will provide compelling pipeline opportunities in neurodegeneration and oncology. We are focused on executing our business strategy and believe these investments have positioned the business to drive long-term profitability and value creation."

    Financial Expectations for 2020

    The following financial expectations for 2020 reflect the anticipated net impacts of the COVID-19 pandemic on Alkermes' operating and financial results.  Alkermes anticipates that the negative impact of COVID-19 on VIVITROL net sales will be partially offset by a decrease in operating expenses, notably within R&D.  The ranges provided are based on current trends and assume that treatment provider practices and patient flow will continue to normalize. Additional wide-spread COVID-19-related restrictions or resurgence of COVID-19 could negatively impact the company's ability to meet these expectations. All line items are according to GAAP, except as otherwise noted.

    In millions (except per share amounts)



    Current 2020 Expectation

    (Provided 7/29/20)

    Pre-COVID-19 Expectation

    (Provided 2/13/20; Suspended 4/29/20)









    Total Revenue



    $965 – $1,005

    $1,030 – $1,080

    VIVITROL Net Sales



    $270 – $300

    $340 – $355

    ARISTADA Net Sales



    $220 – $235

    $220 – $235

    Cost of Goods Sold



    $180 – $190

    $185 – $195

    R&D Expenses



    $370 – $395

    $405 – $430

    SG&A Expenses



    $525 – $550

    $535 – $560

    Amortization of Intangible Assets



    ~$40

    ~$40

    Other Income, Net



    $10 – $15

    Income Tax Expense



    $10 – $15

    $0 – $10

    GAAP Net Loss



    ($145) – ($175)

    ($130) – ($160)

    GAAP Net Loss per Share



    ($0.91) – ($1.10)

    ($0.82) – ($1.01)

    Non-GAAP Net Income



    $0 – $30

    $40 – $70

    Non-GAAP Basic EPS



    $0.00 – $0.19

    $0.25 – $0.44

    Non-GAAP Diluted EPS



    $0.00 – $0.19

    $0.25 – $0.43

    Capital Expenditures



    ~$35

    $45 – $55

    Governance Update

    "Over the past 12 months, we conducted extensive shareholder outreach and engaged with shareholders representing approximately 60% in value of our outstanding ordinary shares. The Board values the views of our shareholders and, after considering their feedback, is taking actions to further strengthen our business and corporate governance practices. The Board believes these actions will help to position the company for long-term growth as we execute on our strategy," said David Anstice, Lead Independent Director of the Alkermes Board of Directors (the Board).

    The company announced today that it plans to take a series of actions as part of its commitment to corporate governance best practices and regular Board refreshment.

    • First, the Board will recommend that shareholders approve, at the company's 2021 Annual General Meeting of Shareholders, an amendment to the company's Articles of Association to declassify the Board. Currently, the Board has three classes of directors, with directors in each class elected to three-year terms. Once the Board is declassified, the directors will be combined into a single class elected annually.
    • Second, the Board has engaged a leading recruitment firm to identify independent director candidates whose experience and expertise offer valuable insights and strategic leadership at this stage in Alkermes' evolution. As part of this process, the company expects certain of its longer-serving directors will retire from the Board. This Board refreshment process will continue and build on the efforts undertaken by the company in the fall of 2019 that led to the addition of two highly-qualified, independent directors, Dr. Richard Gaynor and Mr. Andy Wilson, to the Board.

    Recent Events

    • Schizophrenia portfolio
      • In May 2020, presented new research from the company's schizophrenia portfolio at the American Society of Clinical Psychopharmacology (ASCP) 2020 Annual Meeting, including data from patient-reported evaluations relating to treatment with ALKS 3831 and satisfaction data relating to treatment with ARISTADA.
      • In July 2020, announced a new survey conducted by The Harris Poll for Alkermes, which explored the current use and future potential of telepsychiatry services during and after the COVID-19 pandemic.
    • ALKS 4230
      • In June 2020, presented positive preclinical data from a study designed to evaluate the combination potential of ALKS 4230, Alkermes' investigational engineered interleukin-2 (IL-2) variant immunotherapy, with lucitanib, Clovis Oncology, Inc.'s investigational angiogenesis inhibitor, at the American Association for Cancer Research (AACR) Virtual Annual Meeting II.
    • Corporate citizenship
      • In June 2020, announced that 10 nonprofit organizations were awarded grants from the company's COVID-19 Relief Fund, a special edition of the company's signature Alkermes Inspiration Grants® program, that was established to assist nonprofit organizations in their work to rapidly address pandemic-related needs for people living with addiction, serious mental illness, or cancer.
      • In July 2020, published Alkermes' latest Corporate Responsibility Report which outlines how the company integrates environmental, social and governance considerations into all aspects of its business. A copy of the report is available on the Responsibility section of Alkermes' website.

    Conference Call

    Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, July 29, 2020, to discuss these financial results, financial expectations, and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes' website at www.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 will be available from 11:00 a.m. ET (4:00 p.m. BST) on Wednesday, July 29, 2020, through Wednesday, Aug. 5, 2020, and may be accessed by visiting Alkermes' website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay conference ID is 13707215.

    About Alkermes plc

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    Non-GAAP Financial Measures

    This press release includes information about certain financial measures that are not prepared in accordance with GAAP, including non-GAAP net income (loss) and non-GAAP basic and diluted earnings (loss) per share. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies.

    Non-GAAP net income (loss) adjusts for one-time and non-cash charges by excluding from GAAP results: share-based compensation expense; amortization; depreciation; non-cash net interest expense; changes in the fair value of the contingent consideration; certain other one-time or non-cash items; and the income tax effect of these reconciling items.

    The company's management and the Board utilize these non-GAAP financial measures to evaluate the company's performance. The company provides these non-GAAP measures of the company's performance to investors because management believes that these non-GAAP financial measures, when viewed with the company's results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, non-GAAP net income (loss) and non-GAAP basic and diluted earnings (loss) per share are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, non-GAAP net income (loss) and non-GAAP basic and diluted earnings (loss) per share should not be considered measures of the company's liquidity.

    A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release.

    Note Regarding Forward-Looking Statements

    Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company's expectations concerning future financial and operating performance, business plans or prospects, including the anticipated ongoing impacts of COVID-19 on the company's business and financial performance, the company's assumptions with respect to normalization of patient and healthcare provider practices, the expected growth drivers of the company's business, and the company's ability to drive significant value creation and long-term growth and profitability; the potential therapeutic and commercial value of the company's marketed and development products and the company's potential contributions to supporting patient access to such products; the company's plans for, and expectations relating to, corporate governance changes, including the proposed declassification and refreshment of the Board; expectations concerning future development activities for the company's development candidates; and expectations and timelines concerning the company's commercial activities and capabilities, including in relation to the potential launch of ALKS 3831 following U.S. Food and Drug Administration's ("FDA") review and potential approval of the new drug application ("NDA") for ALKS 3831. The company cautions that forward-looking statements are inherently uncertain. The forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: the impacts of the ongoing COVID-19 pandemic and continued efforts to mitigate its spread on the company's business, results of operations or financial condition, including: impacts on the vendors or distribution channels in its supply chain, and the company's ability to continue to manufacture its products; impacts on its ability to continue its discovery activities; impacts on the conduct of its clinical trials, including with respect to enrollment rates, availability of investigators and clinical trial sites and monitoring of data; impacts on healthcare systems that serve people living with opioid dependence, alcohol dependence and schizophrenia and on patient and healthcare provider access to the company's medicines; impacts on the regulatory agencies with which the company interacts in the development, review, approval and commercialization of its medicines; impacts on reimbursement for the company's products, including its Medicaid rebate liability, and for services related to the use of its products; and impacts on the U.S., Irish and/or global economies more broadly; the unfavorable outcome of litigation, including so-called "Paragraph IV" litigation and other patent litigation, related to any of the company's products or products using the company's proprietary technologies, which may lead to competition from generic drug manufacturers; clinical development activities may not be completed on time or at all; the results of the company's clinical development activities may not be positive, or predictive of real-world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products, including decisions not to approve the company's NDAs; data from clinical trials may be interpreted by the FDA in different ways than the company interprets it; the FDA may not agree with the company's regulatory approval strategies or components of its regulatory filings, including the company's clinical trial designs, conduct and methodologies, manufacturing processes and facilities, and the adequacy of the data and other information included in its filings to meet the FDA's requirements for approval; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading "Risk Factors" in the company's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q and in subsequent filings made by the company with the U.S. Securities and Exchange Commission ("SEC"), which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

    Trademarks

    VIVITROL® is a registered trademark of Alkermes, Inc.; ARISTADA® and ARISTADA INITIO® are registered trademarks of Alkermes Pharma Ireland Limited; VUMERITY® is a registered trademark of Biogen Inc., used by Alkermes under license; and RISPERDAL CONSTA®, INVEGA SUSTENNA®, XEPLION®, INVEGA TRINZA® and TREVICTA® are registered trademarks of Johnson & Johnson.

    (tables follow)

    i The term "ARISTADA" as used in this press release refers to ARISTADA and ARISTADA INITIO, unless the context indicates otherwise.

    Alkermes plc and Subsidiaries

    Selected Financial Information (Unaudited)











    Condensed Consolidated Statements of Operations - GAAP



    Three Months Ended 



    Three Months Ended 

    (In thousands, except per share data)



    June 30, 2020



    June 30, 2019

    Revenues:









    Product sales, net



    $                    130,415



    $                    136,635

    Manufacturing and royalty revenues



    116,505



    127,897

    Research and development revenue



    609



    14,340

    License revenue





    1,000

    Total Revenues



    247,529



    279,872

    Expenses:









    Cost of goods manufactured and sold



    45,053



    46,223

    Research and development



    94,222



    104,435

    Selling, general and administrative



    132,025



    155,075

    Amortization of acquired intangible assets



    9,890



    10,062

    Total Expenses



    281,190



    315,795

    Operating Loss



    (33,661)



    (35,923)

    Other Income (Expense), net:









    Interest income



    1,788



    3,706

    Interest expense



    (2,122)



    (3,520)

    Change in the fair value of contingent consideration



    5,900



    (6,500)

    Other income, net



    2,337



    1,851

    Total Other Income (Expense), net



    7,903



    (4,463)

    Loss Before Income Taxes



    (25,758)



    (40,386)

    Income Tax Provision



    3,673



    1,604

    Net Loss — GAAP



    $                    (29,431)



    $                    (41,990)











    (Loss) Earnings Per Share:









    GAAP loss per share — basic and diluted



    $                        (0.19)



    $                        (0.27)

    Non-GAAP earnings per share — basic and diluted



    $                          0.06



    $                          0.09











    Weighted Average Number of Ordinary Shares Outstanding:









    Basic and diluted — GAAP



    158,895



    156,991

    Basic — Non-GAAP



    158,895



    156,991

    Diluted — Non-GAAP



    159,275



    158,987











    An itemized reconciliation between net loss on a GAAP basis and non-GAAP net income is as follows:

    Net Loss — GAAP



    $                    (29,431)



    $                    (41,990)

    Adjustments:









    Share-based compensation expense



    22,846



    28,245

    Depreciation expense



    10,447



    9,852

    Amortization expense



    9,890



    10,062

    Income tax effect related to reconciling items



    877



    2,043

    Non-cash net interest expense



    167



    168

    Change in the fair value of contingent consideration



    (5,900)



    6,500

    Change in the fair value of warrants and equity method investments





    (1,134)

    Non-GAAP Net Income



    $                        8,896



    $                      13,746





















    Condensed Consolidated Statements of Operations - GAAP



    Six Months Ended 



    Six Months Ended 

    (In thousands, except per share data)



    June 30, 2020



    June 30, 2019

    Revenues:









    Product sales, net



    $                    260,141



    $                    236,116

    Manufacturing and royalty revenues



    232,756



    236,812

    Research and development revenue



    852



    29,046

    License Revenue





    1,000

    Total Revenues



    493,749



    502,974

    Expenses:









    Cost of goods manufactured and sold



    92,264



    91,584

    Research and development



    187,501



    207,005

    Selling, general and administrative



    265,397



    296,295

    Amortization of acquired intangible assets



    19,618



    20,014

    Total Expenses



    564,780



    614,898

    Operating Loss



    (71,031)



    (111,924)

    Other Income (Expense), net:









      Interest income



    4,548



    7,276

      Interest expense



    (4,979)



    (7,020)

      Change in the fair value of contingent consideration



    12,700



    (29,100)

      Other income, net



    1,679



    130

    Total Other Income (Expense), net



    13,948



    (28,714)

    Loss Before Income Taxes



    (57,083)



    (140,638)

    Provision (Benefit) for Income Taxes



    11,002



    (2,250)

    Net Loss — GAAP



    $                     (68,085)



    $                  (138,388)











    (Loss) Earnings Per Share:









    GAAP loss per share — basic and diluted



    $                         (0.43)