ALKS Alkermes plc

27.97
+0.11  (+0%)
Previous Close 27.86
Open 27.74
52 Week Low 15.35
52 Week High 27.93
Market Cap $4,512,442,670
Shares 161,331,522
Float 115,714,613
Enterprise Value $4,059,882,474
Volume 2,241,634
Av. Daily Volume 2,072,878
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Drug Pipeline

Drug Stage Notes
Nemvaleukin (ALKS 4230) - ARTISTRY-1
Solid tumors
Phase 1
Phase 1
Phase 1/2 data presented at ASCO June 4, 2021. 2/6 patients in melanoma monotherapy cohort showed partial responses.
LYBALVI (olanzapine/samidorphan)
Schizophrenia, bipolar
Approved
Approved
FDA approval announced June 1, 2021.
ARISTADA INITIO(aripiprazole lauroxil)
Schizophrenia
Approved
Approved
FDA approval announced July 2, 2018.
VUMERITY (Diroximel fumarate)
Multiple sclerosis (MS)
Approved
Approved
FDA Approval announced October 30, 2019.
ARISTADA (aripiprazole lauroxil)
Schizophrenia
Approved
Approved
Approved October 5 2015. sNDA filed for 2-month option with approval announced June 6, 2017.
Nemvaleukin (ALKS 4230) - (ARTISTRY-6)
Melanoma
Phase 2
Phase 2
Phase 2 trial initiation announced April 27, 2021.
Nemvaleukin (ALKS 4230) - (ARTISTRY-3)
Solid Tumors
Phase 3
Phase 3
Phase 2 trial initiation announced August 18, 2020.
Nemvaleukin (ALKS 4230)
Ovarian cancer
Phase 3
Phase 3
Phase 3 trial to commence 2H 2021.
Diroximel fumarate (BIIB098) - Head-to-head trial versus Tecfidera -
Relapsing Remitting Multiple Sclerosis (RRMS)
Phase 3
Phase 3
Phase 3 top-line data met primary endpoint - July 30, 2019.
ALKS 5461
Major depressive disorder
CRL
CRL
CRL announced February 1, 2019.

Latest News

  1. DUBLIN, Aug. 2, 2021 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nemvaleukin alfa (nemvaleukin), the company's novel, investigational engineered interleukin-2 (IL-2) variant immunotherapy, for the treatment of mucosal melanoma. Earlier this year, the FDA also granted orphan drug designation to nemvaleukin for the treatment of mucosal melanoma. The company recently initiated enrollment in ARTISTRY-6, a global phase 2 trial evaluating the anti-tumor activity, safety and tolerability of nemvaleukin monotherapy in patients with melanoma who have been previously treated with anti-PD-(L)1 therapy. The study is evaluating intravenously administered…

    DUBLIN, Aug. 2, 2021 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nemvaleukin alfa (nemvaleukin), the company's novel, investigational engineered interleukin-2 (IL-2) variant immunotherapy, for the treatment of mucosal melanoma. Earlier this year, the FDA also granted orphan drug designation to nemvaleukin for the treatment of mucosal melanoma. The company recently initiated enrollment in ARTISTRY-6, a global phase 2 trial evaluating the anti-tumor activity, safety and tolerability of nemvaleukin monotherapy in patients with melanoma who have been previously treated with anti-PD-(L)1 therapy. The study is evaluating intravenously administered nemvaleukin in patients with mucosal melanoma and subcutaneously administered nemvaleukin in patients with advanced cutaneous melanoma.

    "Receiving Fast Track designation from the FDA for nemvaleukin for the treatment of mucosal melanoma is an important milestone for the nemvaleukin development program and underscores nemvaleukin's potential clinical utility to address an unmet medical need in this difficult-to-treat tumor type," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "We are committed to advancing this important research in mucosal melanoma, a rare and aggressive form of melanoma for which there are very limited treatment options, particularly for those patients previously treated with checkpoint inhibitors."

    Fast Track is an FDA process designed to facilitate the development and expedite the review of potential therapies that seek to treat serious conditions and fill an unmet medical need. A drug candidate that receives Fast Track designation is eligible for more frequent communication with the FDA throughout the drug development process and a rolling and/or priority review of its marketing application if relevant criteria are met. For more information on Fast Track designation, please visit the FDA's website, available at https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.

    More information on the ARTISTRY-6 study can be found at www.clinicaltrials.gov, identifier: NCT04830124.

    About Nemvaleukin Alfa ("nemvaleukin")

    Nemvaleukin 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 nemvaleukin 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 nemvaleukin as a potential immunotherapy for cancer. The ARTISTRY program is comprised of multiple clinical trials evaluating intravenous and subcutaneous dosing of nemvaleukin, both as a monotherapy and in combination with the anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with advanced solid tumors. Ongoing trials include: ARTISTRY-1ARTISTRY-2ARTISTRY-3 and ARTISTRY-6.

    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, schizophrenia and bipolar I disorder, and a pipeline of product candidates in development for 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 nemvaleukin, whether as monotherapy or in combination and whether delivered intravenously or subcutaneously, as a cancer immunotherapy, including in the treatment of mucosal melanoma; the expected benefits of FDA Fast Track designation; and the company's commitment to advancing research in mucosal melanoma. 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 nemvaleukin could be shown to be unsafe or ineffective; whether preclinical results and data from ongoing clinical studies for nemvaleukin 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 nemvaleukin 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 nemvaleukin, including changes relating to impacts of the COVID-19 pandemic on such operations and activities; 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.

    KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

    ###

    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)

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/alkermes-receives-fda-fast-track-designation-for-nemvaleukin-alfa-for-the-treatment-of-mucosal-melanoma-301345719.html

    SOURCE Alkermes plc

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  2. DUBLIN, July 28, 2021 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today reported financial results for the second quarter of 2021 and provided updated financial expectations for full-year 2021.

    "Alkermes' strong performance in the second quarter was driven by commercial execution and our focus on profitability. VIVITROL® and ARISTADA® demonstrated robust sequential and year-over-year growth and VUMERITY® continued on an encouraging launch trajectory," commented Iain Brown, Chief Financial Officer of Alkermes. "Today, we are raising our financial expectations for full-year 2021 to reflect this performance and anticipated continued strength in the business. We believe that we are in a sound financial position to execute on our business strategy…

    DUBLIN, July 28, 2021 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today reported financial results for the second quarter of 2021 and provided updated financial expectations for full-year 2021.

    "Alkermes' strong performance in the second quarter was driven by commercial execution and our focus on profitability. VIVITROL® and ARISTADA® demonstrated robust sequential and year-over-year growth and VUMERITY® continued on an encouraging launch trajectory," commented Iain Brown, Chief Financial Officer of Alkermes. "Today, we are raising our financial expectations for full-year 2021 to reflect this performance and anticipated continued strength in the business. We believe that we are in a sound financial position to execute on our business strategy and efficiently invest in our future potential growth drivers."

    Quarter Ended June 30, 2021 Financial Results

    Revenues

    • Total revenues for the quarter were $303.7 million. This compared to $247.5 million for the same period in the prior year.
    • Net sales of proprietary products for the quarter were $160.8 million, compared to $130.4 million for the same period in the prior year.
      • Net sales of VIVITROL were $88.4 million, compared to $71.6 million for the same period in the prior year, representing an increase of approximately 23%.
      • Net sales of ARISTADAi were $72.4 million, compared to $58.8 million for the same period in the prior year, representing an increase of approximately 23%.
    • Manufacturing and royalty revenues for the quarter were $142.3 million, compared to $116.5 million for the same period in the prior year.
      • Manufacturing and royalty revenues from RISPERDAL CONSTA®, INVEGA SUSTENNA®/XEPLION® and INVEGA TRINZA®/TREVICTA® were $95.5 million, compared to $83.1 million for the same period in the prior year.
      • Manufacturing and royalty revenues from VUMERITY® were $20.3 million, compared to $2.6 million for the same period in the prior year.

    Costs and Expenses

    • Total operating expenses for the quarter were $299.3 million, compared to $281.2 million for the same period in the prior year.
      • Cost of Goods Manufactured and Sold were $53.1 million, compared to $45.1 million for the same period in the prior year.
      • Research and Development (R&D) expenses were $97.5 million, compared to $94.2 million for the same period in the prior year.
      • Selling, General and Administrative (SG&A) expenses were $139.2 million, compared to $132.0 million for the same period in the prior year.

    Profitability

    • Net income according to generally accepted accounting principles in the U.S. (GAAP) was $2.4 million for the quarter, or a basic and diluted GAAP earnings per share of $0.01. This compared to GAAP net loss of $29.4 million, or a basic and diluted GAAP loss per share of $0.19, for the same period in the prior year.
    • Non-GAAP net income was $49.2 million for the quarter, or a non-GAAP basic earnings per share of $0.31 and a non-GAAP diluted earnings per share of $0.30. This compared to non-GAAP net income of $8.9 million, or a non-GAAP basic and diluted earnings per share of $0.06 for the same period in the prior year.

    Balance Sheet

    • At June 30, 2021, the company recorded cash, cash equivalents and total investments of $669.4 million, compared to $627.4 million at March 31, 2021, driven primarily by the company's operating results and changes in working capital. The company's total debt outstanding as of June 30, 2021 was $297.1 million.

    Financial Expectations for 2021

    The following financial expectations for 2021 are based on recent trends and assume continued 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)



    Current 2021 Expectation

    (Provided 7/28/21)

    Prior 2021

    Expectation

    (Provided 2/11/21)









    Total Revenue



    $1,145 – $1,185

    $1,100 – $1,170

    VIVITROL Net Sales



    $330 – $345

    $315 – $345

    ARISTADA Net Sales



    $275 – $290

    $260 – $290

    LYBALVI® Net Sales



    <$10

    <$10

    Cost of Goods Sold



    $195 – $205

    $190 – $200

    R&D Expenses



    $400 – $430*

    $400 – $430*

    SG&A Expenses



    $560 – $590

    $570 – $600

    Amortization of Intangible Assets



    ~$40

    ~$40

    Other Expense, Net



    $0 – $5

    $0

    Income Tax Expense



    $5 – $10

    $0 – $10

    GAAP Net Loss



    ($60) – ($90)

    ($85) – ($125)

    GAAP Net Loss per Share+



    ($0.37) – ($0.56)

    ($0.53) – ($0.78)

    Non-GAAP Net Income



    $85 – $115

    $60 – $100

    Non-GAAP Diluted EPS+



    $0.52 – $0.70

    $0.37 – $0.62

    Capital Expenditures



    ~$35

    ~$40

    *R&D expense expectations for 2021 include an anticipated $25 million milestone payment in the third quarter to the former shareholders of Rodin Therapeutics, Inc. related to the expected 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.

    + The current 2021 per share expectations are calculated based on a weighted average basic share count of approximately 161 million shares outstanding and a weighted average diluted share count of approximately 164 million shares outstanding, as compared to prior expectations of approximately 160 million and 161 million, respectively.

    "Our achievements in the second quarter demonstrated continued execution against our strategic priorities. Our strong commercial performance, the FDA approval of LYBALVI and the accumulating data and operational progress in our nemvaleukin immuno-oncology program represent important milestones for the company and provide a meaningful platform to drive future growth," said Richard Pops, Chief Executive Officer of Alkermes. "Guided by our intense focus on value creation, our objectives for the remainder of 2021 are clear: successfully launch LYBALVI; drive the growth of VIVITROL and ARISTADA; advance the clinical development program for nemvaleukin; and invest in our emerging neuroscience and oncology pipeline assets."

    Recent Events:

    Psychiatry

    • In June 2021, the company announced FDA approval of LYBALVI (olanzapine and samidorphan) for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproateii. LYBALVI is a once-daily, oral atypical antipsychotic composed of olanzapine, an established antipsychotic agent, co-formulated with samidorphan, a new chemical entity, in a single bilayer tablet.

    Nemvaleukin alfa ("nemvaleukin")

    • In June 2021, the company presented updated data from the ARTISTRY clinical development program for nemvaleukin, the company's novel, investigational engineered interleukin-2 (IL-2) variant immunotherapy, at the American Society of Clinical Oncology (ASCO) Annual Meeting. In conjunction with the data presentation at ASCO, the company hosted an investor webcast with ARTISTRY clinical program investigators Valentina Boni, M.D., Ph.D., Medical Oncologist and Principal Investigator at START Madrid at Centro Integral Oncológico Clara Campal and Omid Hamid, M.D., Chief of Research and Immunotherapy at The Angeles Clinic and Research Institute.

    Corporate

    • In May 2021, the company announced the appointment of Emily Peterson Alva to the company's Board of Directors (the Board). Ms. Alva is an experienced public company board member and a financial, strategic and business advisor to growth companies. Ms. Alva is the fifth new, independent director to join the Board in the past two years.
    • In July 2021, the company awarded grants from its Alkermes Inspiration Grants® program to 11 nonprofit organizations working to address the needs of people living with addiction, serious mental illness or cancer.

    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 28, 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 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, schizophrenia and bipolar I disorder, and a pipeline of product candidates in development for 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 certain 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 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 expected drivers of future growth and value creation; expectations of continued improvement in patient access to healthcare providers and to the company's commercial products; the potential therapeutic and commercial value of the company's marketed and development products; expectations concerning the company's future development activities, including plans for submission of an investigational new drug application or equivalent for ALKS 1140, advancement of the clinical development program for nemvaleukin and further investment in the company's neuroscience and oncology development pipeline; and expectations concerning the company's commercial activities, including 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 may not be able to achieve its targeted financial and 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 and 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, or other disputes related to our products or products using our proprietary technologies; 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 final results from such activities, results of future development activities or real-world results; 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; 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; 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 government 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, and ALKERMES INSPIRATION GRANTS® is a registered service mark, of Alkermes, Inc.; ARISTADA®, ARISTADA INITIO® and LYBALVI® are registered trademarks 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)



    June 30, 2021



    June 30, 2020

    Revenues:









    Product sales, net



    $                  160,808



    $                  130,415

    Manufacturing and royalty revenues



    142,294



    116,505

    Research and development revenue



    615



    609

    Total Revenues



    303,717



    247,529

    Expenses:









    Cost of goods manufactured and sold



    53,124



    45,053

    Research and development



    97,473



    94,222

    Selling, general and administrative



    139,188



    132,025

    Amortization of acquired intangible assets



    9,511



    9,890

    Total Expenses



    299,296



    281,190

    Operating Income (Loss)



    4,421



    (33,661)

    Other Income, net:









    Interest income



    623



    1,788

    Interest expense



    (2,407)



    (2,122)

    Change in the fair value of contingent consideration



    3,240



    5,900

    Other (expense) income, net



    (222)



    2,337

    Total Other Income, net



    1,234



    7,903

    Income (Loss) Before Income Taxes



    5,655



    (25,758)

    Provision for Income Taxes



    3,291



    3,673

    Net Income (Loss) — GAAP



    $                      2,364



    $                  (29,431)











    Earnings (Loss) Per Share:









    GAAP earnings (loss) per share — basic and diluted



    $                        0.01



    $                      (0.19)

    Non-GAAP earnings per share — basic



    $                        0.31



    $                        0.06

    Non-GAAP earnings per share — diluted



    $                        0.30



    $                        0.06











    Weighted Average Number of Ordinary Shares Outstanding:









    Basic — GAAP



    160,817



    158,895

    Diluted — GAAP 



    163,937



    158,895

    Basic — Non-GAAP



    160,817



    158,895

    Diluted — Non-GAAP



    163,937



    159,275











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

    Net Income (Loss) — GAAP



    $                      2,364



    $                  (29,431)

    Adjustments:









    Share-based compensation expense



    27,552



    22,846

    Depreciation expense



    8,966



    10,447

    Amortization expense



    9,511



    9,890

    Income tax effect related to reconciling items



    3,927



    877

    Non-cash net interest expense



    117



    167

    Change in the fair value of contingent consideration



    (3,240)



    (5,900)

    Non-GAAP Net Income



    $                    49,197



    $                      8,896









































    Condensed Consolidated Statements of Operations - GAAP



    Six Months Ended 



    Six Months Ended 

    (In thousands, except per share data)



    June 30, 2021



    June 30, 2020

    Revenues:









    Product sales, net



    $                  290,771



    $                  260,141

    Manufacturing and royalty revenues



    262,141



    232,756

    License revenue



    1,500



    Research and development revenue



    735



    852

    Total Revenues



    555,147



    493,749

    Expenses:









    Cost of goods manufactured and sold



    94,144



    92,264

    Research and development



    189,741



    187,501

    Selling, general and administrative



    264,356



    265,397

    Amortization of acquired intangible assets



    18,917



    19,618

    Total Expenses



    567,158



    564,780

    Operating Loss



    (12,011)



    (71,031)

    Other (Expense) Income, net:









      Interest income



    1,487



    4,548

      Interest expense



    (6,377)



    (4,979)

      Change in the fair value of contingent consideration



    4,518



    12,700

      Other (expense) income, net



    (615)



    1,679

    Total Other (Expense) Income, net



    (987)



    13,948

    Loss Before Income Taxes



    (12,998)



    (57,083)

    Provision for Income Taxes



    7,056



    11,002

    Net Loss — GAAP



    $                  (20,054)



    $                  (68,085)











    (Loss) Earnings Per Share:









    GAAP loss per share — basic and diluted



    $                      (0.13)



    $                      (0.43)

    Non-GAAP earnings per share — basic



    $                        0.42



    $                        0.07

    Non-GAAP earnings per share — diluted



    $                        0.41



    $                        0.07











    Weighted Average Number of Ordinary Shares Outstanding:









    Basic and diluted — GAAP



    160,229



    158,495

    Basic — Non-GAAP



    160,229



    158,495

    Diluted — Non-GAAP



    163,174



    159,151











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

    Net Loss — GAAP



    $                  (20,054)



    $                  (68,085)

    Adjustments:









    Share-based compensation expense



    43,003



    42,659

    Depreciation expense



    19,203



    21,328

    Amortization expense



    18,917



    19,618

    Income tax effect related to reconciling items



    8,106



    6,797

    Non-cash net interest expense



    235



    334

    Debt refinancing charge



    2,109



    Change in the fair value of contingent consideration



    (4,518)



    (12,700)

    Acquisition of IPR&D





    674

    Non-GAAP Net Income



    $                    67,001



    $                    10,625































    Condensed Consolidated Balance Sheets



    June 30, 



    December 31, 

    (In thousands)



    2021



    2020

    Cash, cash equivalents and total investments



    $                  669,377



    $                  659,807

    Receivables



    297,357



    275,143

    Contract assets



    8,793



    14,401

    Inventory



    136,077



    125,738

    Prepaid expenses and other current assets



    57,186



    60,662

    Property, plant and equipment, net



    343,949



    350,003

    Intangible assets, net and goodwill



    186,147



    204,064

    Other assets



    238,683



    259,912

    Total Assets



    $               1,937,569



    $               1,949,730

    Long-term debt — current portion



    $                      3,000



    $                      2,843

    Other current liabilities



    380,442



    435,415

    Long-term debt   



    294,070



    272,118

    Contract liabilities — long-term 



    14,167



    16,397

    Other long-term liabilities



    147,988



    155,975

    Total shareholders' equity



    1,097,902



    1,066,982

    Total Liabilities and Shareholders' Equity



    $               1,937,569



    $               1,949,730











    Ordinary shares outstanding (in thousands)



    161,296



    159,161











    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 six months ended June 30, 2021, which the company intends to file in July 2021.

     

    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



    $                      (75.0)



    161



    $       (0.47)

       Adjustments:













    Share-based compensation expense



    90.0









    Depreciation expense



    42.0









    Amortization expense



    40.0









    Income tax effect related to reconciling items 



    5.0









    Other (expense) income, net



    2.0









    Non-cash net interest expense



    1.0









    Change in the fair value of contingent consideration



    (5.0)









    Projected Net Income — Non-GAAP



    $                      100.0



    164



    $        0.61















    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 Full prescribing information, including boxed warning, for LYBALVI may be found at www.lybalvi.com/lybalvi-prescribing-information.pdf

    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:https://www.prnewswire.com/news-releases/alkermes-plc-reports-second-quarter-2021-financial-results-301343014.html

    SOURCE Alkermes plc

    View Full Article Hide Full Article
  3. 5th Installment of Competitive Grants Program Awards 11 Grants to Innovative Programs Focused on People Living With Addiction, Serious Mental Illness or Cancer

    Northampton, MA

    --News Direct--

    DUBLIN, July 23, 2021 /3BL Media/ -- Alkermes plc (NASDAQ:ALKS) today announced the 2021 recipients of grants from the company's signature Alkermes Inspiration Grants® program. Grants were awarded to 11 nonprofit organizations working to address the needs of people living with addiction, serious mental illness or cancer, including programs serving historically under-resourced or underrepresented communities, including Black, Indigenous and people of color (BIPOC), LGBTQ+ individuals, veterans, women and people impacted by the U.S. criminal justice system.

    "Now…

    5th Installment of Competitive Grants Program Awards 11 Grants to Innovative Programs Focused on People Living With Addiction, Serious Mental Illness or Cancer

    Northampton, MA

    --News Direct--

    DUBLIN, July 23, 2021 /3BL Media/ -- Alkermes plc (NASDAQ:ALKS) today announced the 2021 recipients of grants from the company's signature Alkermes Inspiration Grants® program. Grants were awarded to 11 nonprofit organizations working to address the needs of people living with addiction, serious mental illness or cancer, including programs serving historically under-resourced or underrepresented communities, including Black, Indigenous and people of color (BIPOC), LGBTQ+ individuals, veterans, women and people impacted by the U.S. criminal justice system.

    "Now in its fifth year, the Alkermes Inspiration Grants program exemplifies our long-standing commitment to supporting organizations that seek to address patient needs beyond those directly related to their treatment. This year's program prioritized funding for programs designed to support communities whose needs may be exacerbated by population-based health disparities," said Richard Pops, Chief Executive Officer of Alkermes. "We are proud to support this year's grantees, who are working on the frontlines to bring unique and innovative resources to people living with complex conditions who may benefit from support outside of what healthcare systems typically provide."

    2021 Grant Recipient Organizations and Programs:

    The Artistic Recovery's program will provide free online recovery support through a series of videos, podcasts and blogs. People in recovery will create content designed to support those in early recovery from substance use disorder. Individuals will have the opportunity to practice social skills while sober to increase their confidence to participate in everyday life without the need for drugs or alcohol. The program activities and resource topics include cooking, nutrition, art projects, faith, fitness, music lessons, song writing and virtual recovery support sessions.

    Cancer Research Institute's Immunotherapy Summit will feature Spanish-speaking experts and patients who are members of the Hispanic and Latinx communities to raise awareness of immuno-oncology (I-O) as a cancer treatment option, connect patients and caregivers with top I-O experts, and empower patients to discuss I-O treatment options with their healthcare providers. Participants will be able to listen to a patient panel discussion in Spanish to hear about others' I-O treatment experiences and meet with a clinical trials navigator to learn about clinical trials for which they may be eligible.

    The Council of State Governments Justice Center will promote Community Responder Programs (CRPs) to reduce involvement with the U.S. criminal justice system and improve access to treatment for people with serious mental illness and addiction. CRPs dispatch health professionals in response to 911 calls involving people in a behavioral health crisis. Written guidance will be developed to inform local CRP efforts and converted into an online, interactive tool for communities. The program will engage under-resourced communities to inform development of the tool and help make CRPs available to communities nationwide.

    Depression and Bipolar Support Alliance (DBSA) will focus its program on increasing access to no-cost peer support groups for Black individuals living with depression or bipolar disorder with the purpose of mitigating negative mental health outcomes that may be exacerbated by systemic racism. The program also includes development of additional resources to support this work more broadly through DBSA's local chapter network. 

    Imerman Angels' Diversity, Equity & Inclusion Ambassadors program will expand services and increase outreach to provide cancer fighters, survivors, previvors and caregivers in traditionally underserved BIPOC and LGBTQIA+ communities comfort and understanding through a personalized, one-on-one connection with a peer who has received, or who has a loved one who has received, the same diagnosis.

    National Ovarian Cancer Coalition plans to enhance and expand its Animated Patient's Guide to Ovarian Cancer for Improved Health Outcomes to include two new modules: Understanding Clinical Trials and Understanding Biomarkers and Genetic Mutations. Designed for patients, families and the public at large, the program will also provide an expert-authored, evidence-based education series for healthcare professionals based on recommendations from the American Medical Association for patient communication and education.

    National Sheriffs' Educational Foundation's Medication-Assisted Treatment (MAT) Sheriff-to-Sheriff Peer Mentoring Program will guide sheriffs and jail administrators seeking practical examples for implementing MAT for justice-involved individuals with substance use disorder and/or mental illness. Through peer mentoring, the program will seek to identify strategies to overcome barriers, provide proper treatment and ensure that continuation-of-care plans are implemented upon reentry into society after incarceration. The goal of this program is to increase the recovery rate and reduce recidivism for justice-involved individuals by enhancing care delivery in jails and upon reentry.

    Patriot PAWS Service Dogs conducts a Veteran Outreach and Team Training Program that empowers veterans to create support networks, prepares them for receiving service dogs and ensures that veterans are utilizing available resources. The organization's Prison Training Program teaches inmates the skill of training service dogs, which they can use upon their release back into society as a means for employment, while providing inmates with a fulfilling purpose during their time in prison. Through Patriot PAWS Programs, veterans and inmates can regain lost independence and emotional stability.

    SHE RECOVERS Foundation (SRF) will conduct Mental Health Mondays, a series of virtual one-hour educational sessions designed to support the health and well-being of women experiencing addiction and/or serious mental illness. The webinars will be delivered by content experts, including clinicians and individuals with lived experience. Topics will be gleaned from consultation with SRF's population-based support groups – including Black, Indigenous and women of color; LGBTQ+ individuals; veterans and first responders; healthcare professionals; and individuals living with mood and anxiety disorders.

    Sound Mind Live's Road to Recovery Community Outreach Program partners with touring artists of color who are affected by mental illness to increase awareness of and access to mental health resources for communities of color. These artists serve as crucial role models by telling their own stories while on tour, encouraging audiences in their communities to seek support and treatment. With a focus on cities with the greatest income inequality, these tours increase access to free mental health resources and services for underserved and underrepresented communities around the country through partnerships with community-based mental health organizations.

    We Bloom's five Recovery Cafés across the state of Indiana offer services catered toward building social and emotional health, community connectedness and recovery capital with a focus on holistic, long-term recovery that supports its members beyond treatment. The Recovery Cafés' services include peer support, resources and daily meals, and activities and classes to support, empower and encourage members on their journey of recovery from substance use disorders, mental illness, trauma, grief, loss, poverty, homelessness and/or family violence.

    More than 250 applications were submitted for this highly-competitive program. Submissions were evaluated based on a set of pre-determined criteria, including a focus on people living with addiction, serious mental illness or cancer; clearly defined needs, objectives, activity format, mode of delivery and intended audience; and relevance to historically under-resourced or underrepresented communities. Grant recipients were selected by Alkermes.

    "Over the past year we have seen increased stigma related to mental health and reduced access to care in historically marginalized communities. In our experience, artists' voices and platforms can have a profound impact on fostering more positive cultural narratives around mental health," said Chris Bullard, Executive Director of Sound Mind Live, a 2021 grant recipient. "Funding from the Alkermes Inspiration Grants program will enable us to work with artists who identify with these communities to leverage the power of music and the arts to build community and open dialogue."

    Since 2016, the Alkermes Inspiration Grants program has awarded more than $4 million in funding to innovative programs that support the needs of those impacted by serious diseases in our areas of focus. For more information on the Alkermes Inspiration Grants program, please visit https://www.alkermes.com/responsibility.

    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, schizophrenia and bipolar I disorder, and a pipeline of product candidates in development for 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 INSPIRATION GRANTS is a registered service mark of Alkermes, Inc.

    Alkermes Contacts:

    For Investors: Alex Braun, +1 781 296 9493

    For Media: Gretchen Murphy, +1 781 609 6419

    ###

    View additional multimedia and more ESG storytelling from Alkermes on 3blmedia.com

    View source version on newsdirect.com: https://newsdirect.com/news/alkermes-announces-recipients-of-2021-alkermes-inspiration-grants-r-program-167193732

    2021 News Direct Corp.

    View Full Article Hide Full Article
  4. DUBLIN, July 23, 2021 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced the 2021 recipients of grants from the company's signature Alkermes Inspiration Grants® program. Grants were awarded to 11 nonprofit organizations working to address the needs of people living with addiction, serious mental illness or cancer, including programs serving historically under-resourced or underrepresented communities, including Black, Indigenous and people of color (BIPOC), LGBTQ+ individuals, veterans, women and people impacted by the U.S. criminal justice system.

    "Now in its fifth year, the Alkermes Inspiration Grants program exemplifies our long-standing commitment to supporting organizations that seek to address patient needs beyond those directly…

    DUBLIN, July 23, 2021 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced the 2021 recipients of grants from the company's signature Alkermes Inspiration Grants® program. Grants were awarded to 11 nonprofit organizations working to address the needs of people living with addiction, serious mental illness or cancer, including programs serving historically under-resourced or underrepresented communities, including Black, Indigenous and people of color (BIPOC), LGBTQ+ individuals, veterans, women and people impacted by the U.S. criminal justice system.

    "Now in its fifth year, the Alkermes Inspiration Grants program exemplifies our long-standing commitment to supporting organizations that seek to address patient needs beyond those directly related to their treatment. This year's program prioritized funding for programs designed to support communities whose needs may be exacerbated by population-based health disparities," said Richard Pops, Chief Executive Officer of Alkermes. "We are proud to support this year's grantees, who are working on the frontlines to bring unique and innovative resources to people living with complex conditions who may benefit from support outside of what healthcare systems typically provide."

    2021 Grant Recipient Organizations and Programs:

    The Artistic Recovery's program will provide free online recovery support through a series of videos, podcasts and blogs. People in recovery will create content designed to support those in early recovery from substance use disorder. Individuals will have the opportunity to practice social skills while sober to increase their confidence to participate in everyday life without the need for drugs or alcohol. The program activities and resource topics include cooking, nutrition, art projects, faith, fitness, music lessons, song writing and virtual recovery support sessions.

    Cancer Research Institute's Immunotherapy Summit will feature Spanish-speaking experts and patients who are members of the Hispanic and Latinx communities to raise awareness of immuno-oncology (I-O) as a cancer treatment option, connect patients and caregivers with top I-O experts, and empower patients to discuss I-O treatment options with their healthcare providers. Participants will be able to listen to a patient panel discussion in Spanish to hear about others' I-O treatment experiences and meet with a clinical trials navigator to learn about clinical trials for which they may be eligible.

    The Council of State Governments Justice Center will promote Community Responder Programs (CRPs) to reduce involvement with the U.S. criminal justice system and improve access to treatment for people with serious mental illness and addiction. CRPs dispatch health professionals in response to 911 calls involving people in a behavioral health crisis. Written guidance will be developed to inform local CRP efforts and converted into an online, interactive tool for communities. The program will engage under-resourced communities to inform development of the tool and help make CRPs available to communities nationwide.

    Depression and Bipolar Support Alliance (DBSA) will focus its program on increasing access to no-cost peer support groups for Black individuals living with depression or bipolar disorder with the purpose of mitigating negative mental health outcomes that may be exacerbated by systemic racism. The program also includes development of additional resources to support this work more broadly through DBSA's local chapter network. 

    Imerman Angels' Diversity, Equity & Inclusion Ambassadors program will expand services and increase outreach to provide cancer fighters, survivors, previvors and caregivers in traditionally underserved BIPOC and LGBTQIA+ communities comfort and understanding through a personalized, one-on-one connection with a peer who has received, or who has a loved one who has received, the same diagnosis.

    National Ovarian Cancer Coalition plans to enhance and expand its Animated Patient's Guide to Ovarian Cancer for Improved Health Outcomes to include two new modules: Understanding Clinical Trials and Understanding Biomarkers and Genetic Mutations. Designed for patients, families and the public at large, the program will also provide an expert-authored, evidence-based education series for healthcare professionals based on recommendations from the American Medical Association for patient communication and education.

    National Sheriffs' Educational Foundation's Medication-Assisted Treatment (MAT) Sheriff-to-Sheriff Peer Mentoring Program will guide sheriffs and jail administrators seeking practical examples for implementing MAT for justice-involved individuals with substance use disorder and/or mental illness. Through peer mentoring, the program will seek to identify strategies to overcome barriers, provide proper treatment and ensure that continuation-of-care plans are implemented upon reentry into society after incarceration. The goal of this program is to increase the recovery rate and reduce recidivism for justice-involved individuals by enhancing care delivery in jails and upon reentry.

    Patriot PAWS Service Dogs conducts a Veteran Outreach and Team Training Program that empowers veterans to create support networks, prepares them for receiving service dogs and ensures that veterans are utilizing available resources. The organization's Prison Training Program teaches inmates the skill of training service dogs, which they can use upon their release back into society as a means for employment, while providing inmates with a fulfilling purpose during their time in prison. Through Patriot PAWS Programs, veterans and inmates can regain lost independence and emotional stability.

    SHE RECOVERS Foundation (SRF) will conduct Mental Health Mondays, a series of virtual one-hour educational sessions designed to support the health and well-being of women experiencing addiction and/or serious mental illness. The webinars will be delivered by content experts, including clinicians and individuals with lived experience. Topics will be gleaned from consultation with SRF's population-based support groups – including Black, Indigenous and women of color; LGBTQ+ individuals; veterans and first responders; healthcare professionals; and individuals living with mood and anxiety disorders.

    Sound Mind Live's Road to Recovery Community Outreach Program partners with touring artists of color who are affected by mental illness to increase awareness of and access to mental health resources for communities of color. These artists serve as crucial role models by telling their own stories while on tour, encouraging audiences in their communities to seek support and treatment. With a focus on cities with the greatest income inequality, these tours increase access to free mental health resources and services for underserved and underrepresented communities around the country through partnerships with community-based mental health organizations.

    We Bloom's five Recovery Cafés across the state of Indiana offer services catered toward building social and emotional health, community connectedness and recovery capital with a focus on holistic, long-term recovery that supports its members beyond treatment. The Recovery Cafés' services include peer support, resources and daily meals, and activities and classes to support, empower and encourage members on their journey of recovery from substance use disorders, mental illness, trauma, grief, loss, poverty, homelessness and/or family violence.

    More than 250 applications were submitted for this highly-competitive program. Submissions were evaluated based on a set of pre-determined criteria, including a focus on people living with addiction, serious mental illness or cancer; clearly defined needs, objectives, activity format, mode of delivery and intended audience; and relevance to historically under-resourced or underrepresented communities. Grant recipients were selected by Alkermes.

    "Over the past year we have seen increased stigma related to mental health and reduced access to care in historically marginalized communities. In our experience, artists' voices and platforms can have a profound impact on fostering more positive cultural narratives around mental health," said Chris Bullard, Executive Director of Sound Mind Live, a 2021 grant recipient. "Funding from the Alkermes Inspiration Grants program will enable us to work with artists who identify with these communities to leverage the power of music and the arts to build community and open dialogue."

    Since 2016, the Alkermes Inspiration Grants program has awarded more than $4 million in funding to innovative programs that support the needs of those impacted by serious diseases in our areas of focus. For more information on the Alkermes Inspiration Grants program, please visit https://www.alkermes.com/responsibility.

    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, schizophrenia and bipolar I disorder, and a pipeline of product candidates in development for 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 INSPIRATION GRANTS is a registered service mark of Alkermes, Inc.

    Alkermes Contacts:

    For Investors: Alex Braun, +1 781 296 9493

    For Media: Gretchen Murphy, +1 781 609 6419

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/alkermes-announces-recipients-of-2021-alkermes-inspiration-grants-program-301340034.html

    SOURCE Alkermes plc

    View Full Article Hide Full Article
  5. Northampton, MA

    --News Direct--

    If you're concerned about your drinking habits, it may be helpful to talk to your healthcare provider. These questions can help start the conversation because while it's never easy to talk about alcohol dependence, it's always important: 

    • What is alcohol dependence?
    • What are some of the warning signs of alcohol dependence?
    • How might alcohol dependence affect other aspects of my health (now or over time)?

    Learn more: https://bit.ly/3eJu3th

    View additional multimedia and more ESG storytelling from Alkermes on 3blmedia.com

    View source version on newsdirect.com: https://newsdirect.com/news/questions-to-consider-asking-your-hcp-about-alcohol-dependence-123254665

    2021 News Direct Corp.

    Northampton, MA

    --News Direct--

    If you're concerned about your drinking habits, it may be helpful to talk to your healthcare provider. These questions can help start the conversation because while it's never easy to talk about alcohol dependence, it's always important: 

    • What is alcohol dependence?
    • What are some of the warning signs of alcohol dependence?
    • How might alcohol dependence affect other aspects of my health (now or over time)?

    Learn more: https://bit.ly/3eJu3th

    View additional multimedia and more ESG storytelling from Alkermes on 3blmedia.com

    View source version on newsdirect.com: https://newsdirect.com/news/questions-to-consider-asking-your-hcp-about-alcohol-dependence-123254665

    2021 News Direct Corp.

    View Full Article Hide Full Article
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