1. Acorda Therapeutics, Inc. (NASDAQ:ACOR) announced that Ron Cohen, M.D., President and Chief Executive Officer, will present during the March 9th & 10th H.C. Wainwright Global Life Sciences Virtual Conference. For more information about the conference, please visit the event website at https://hcwevents.com/globalconference/.

    About Acorda Therapeutics

    Acorda Therapeutics develops therapies to restore function and improve the lives of people with neurological disorders. INBRIJA® (levodopa inhalation powder) is approved for intermittent treatment of OFF episodes in adults with Parkinson's disease treated with carbidopa/levodopa. INBRIJA is not to be used by patients who take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine…

    Acorda Therapeutics, Inc. (NASDAQ:ACOR) announced that Ron Cohen, M.D., President and Chief Executive Officer, will present during the March 9th & 10th H.C. Wainwright Global Life Sciences Virtual Conference. For more information about the conference, please visit the event website at https://hcwevents.com/globalconference/.

    About Acorda Therapeutics

    Acorda Therapeutics develops therapies to restore function and improve the lives of people with neurological disorders. INBRIJA® (levodopa inhalation powder) is approved for intermittent treatment of OFF episodes in adults with Parkinson's disease treated with carbidopa/levodopa. INBRIJA is not to be used by patients who take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last two weeks. INBRIJA utilizes Acorda's innovative ARCUS® pulmonary delivery system, a technology platform designed to deliver medication through inhalation. Acorda also markets the branded AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg.

    Forward-Looking Statements

    This press release includes forward-looking statements. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including: we may not be able to successfully market AMPYRA, INBRIJA or any other products under development; the COVID-19 pandemic, including related quarantines and travel restrictions, and the potential for the illness to affect our employees or consultants or those that work for other companies we rely upon, could have a material adverse effect on our business operations or product sales; our ability to raise additional funds to finance our operations, repay outstanding indebtedness or satisfy other obligations, and our ability to control our costs or reduce planned expenditures; risks associated with the trading of our common stock and our reverse stock split; risks related to our workforce, including our ability to realize the expected benefits of our corporate restructuring; risks associated with complex, regulated manufacturing processes for pharmaceuticals, which could affect whether we have sufficient commercial supply of INBRIJA to meet market demand; our reliance on third-party manufacturers for the production of commercial supplies of AMPYRA and INBRIJA; third party payers (including governmental agencies) may not reimburse for the use of INBRIJA or our other products at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; competition for INBRIJA, AMPYRA and other products we may develop and market in the future, including increasing competition and accompanying loss of revenues in the U.S. from generic versions of AMPYRA (dalfampridine) following our loss of patent exclusivity; the ability to realize the benefits anticipated from acquisitions, among other reasons because acquired development programs are generally subject to all the risks inherent in the drug development process and our knowledge of the risks specifically relevant to acquired programs generally improves over time; the risk of unfavorable results from future studies of INBRIJA (levodopa inhalation powder) or from our other research and development programs, or any other acquired or in-licensed programs; the occurrence of adverse safety events with our products; the outcome (by judgment or settlement) and costs of legal, administrative or regulatory proceedings, investigations or inspections, including, without limitation, collective, representative or class action litigation; failure to protect our intellectual property, to defend against the intellectual property claims of others or to obtain third party intellectual property licenses needed for the commercialization of our products; and failure to comply with regulatory requirements could result in adverse action by regulatory agencies.

    These and other risks are described in greater detail in our filings with the Securities and Exchange Commission. We may not actually achieve the goals or plans described in our forward-looking statements, and investors should not place undue reliance on these statements. Forward-looking statements made in this press release are made only as of the date hereof, and we disclaim any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

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    • Sale of Manufacturing Operations to Catalent with net proceeds of ~$74 million
    • Annual operating expenses cut by ~$40 million via sale, restructuring, and other reductions
    • Total 2021 non-GAAP operating expense expected to be $130-$140 million1
    • AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg 2021 net revenue expected to be $75-$85 million
    • INBRIJA® (levodopa inhalation powder) 2020 net revenue $24 million
    • AMPYRA 2020 net revenue $99 million

    Acorda Therapeutics, Inc. (NASDAQ:ACOR) today provided a business update and reported its financial results for the fourth quarter and full year ended December 31, 2020.

    "We have improved our financial position materially through the sale of our manufacturing operations in Chelsea and our…

    • Sale of Manufacturing Operations to Catalent with net proceeds of ~$74 million
    • Annual operating expenses cut by ~$40 million via sale, restructuring, and other reductions
    • Total 2021 non-GAAP operating expense expected to be $130-$140 million1
    • AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg 2021 net revenue expected to be $75-$85 million
    • INBRIJA® (levodopa inhalation powder) 2020 net revenue $24 million
    • AMPYRA 2020 net revenue $99 million

    Acorda Therapeutics, Inc. (NASDAQ:ACOR) today provided a business update and reported its financial results for the fourth quarter and full year ended December 31, 2020.

    "We have improved our financial position materially through the sale of our manufacturing operations in Chelsea and our restructuring, which also have reduced both our annual operating expenses and cost of goods for INBRIJA," said Ron Cohen, M.D., Acorda's President and Chief Executive Officer. "In 2020, we continued to improve access to INBRIJA and saw excellent results from our new patient education and training programs; for example, approximately 1,250 patients who had either never filled or had discontinued their original INBRIJA prescriptions responded to our educational outreach and training by returning to therapy. We also saw quarter over quarter growth in INBRIJA despite the substantial negative impact of COVID-19, and believe we are well-positioned for further growth when the pandemic subsides. We also believe that the reduced cost of goods for INBRIJA will help potentiate commercial partnerships outside the US."

    Fourth Quarter 2020 Financial Results

    For the fourth quarter ended December 31, 2020, the Company reported AMPYRA net revenue of $25.3 million compared to $40.8 million for the same quarter in 2019 and INBRIJA net revenue of $9.3 million compared to $6.1 million for the same quarter in 2019.

    Research and development (R&D) expenses for the quarter ended December 31, 2020 were $4.3 million, including $0.3 million of share-based compensation, compared to $9.0 million, including $0.6 million of share-based compensation, for the same quarter in 2019.

    Sales, general and administrative (SG&A) expenses for the quarter ended December 31, 2020 were $32.9 million, including $1.2 million of share-based compensation, compared to $41.2 million, including $2.0 million of share-based compensation, for the same quarter in 2019.

    Benefit from income taxes for the quarter ended December 31, 2020 was $3.1 million, compared to a benefit from income taxes of $0.8 million for the same quarter in 2019.

    The Company recorded a loss on assets held for sale related to the sale of the manufacturing operations in Chelsea, Massachusetts to Catalent. The Company recorded a loss on the assets held for sale of $57.9 million as of December 31, 2020, which represents the amount by which the carrying value of the assets to be sold exceeds the purchase price less estimated selling costs. The Company segregated the assets held for sale on the balance sheet at the resulting carrying amount of $71.8 million as of December 31, 2020.

    The Company reported GAAP net loss of $83.0 million for the quarter ended December 31, 2020, or $9.82 per diluted share. GAAP net income in the same quarter of 2019 was $65.7 million, or $8.26 per diluted share.

    Non-GAAP net loss for the quarter ended December 31, 2020 was $21.1 million, or $2.50 per diluted share. Non-GAAP net loss in the same quarter of 2019 was $7.1 million, or $0.89 per diluted share. This quarterly non-GAAP net loss measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, restructuring expenses, changes in the fair value of acquired contingent consideration, losses on assets held for sale, gain on extinguishment of debt, and changes in the fair value of derivative liability related to the 2024 convertible notes. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

    Full Year Ended December 31, 2020 Financial Results

    For the full year ended December 31, 2020, the Company reported AMPYRA net revenue of $98.9 million compared to $163.2 million for the full year 2019 and INBRIJA net revenue of $24.2 million compared to $15.3 million for the full year 2019.

    Research and development (R&D) expenses for the full year ended December 31, 2020 were $23.0 million, including $1.7 million of share-based compensation, compared to $60.1 million, including $2.8 million of share-based compensation for the full year 2019.

    Sales, general and administrative (SG&A) expenses for the full year ended December 31, 2020 were $152.6 million, including $6.0 million of share-based compensation, compared to $192.8 million, including $10.8 million of share-based compensation for the full year 2019.

    Benefit from income taxes for the full year ended December 31, 2020 was $8.0 million, compared to a benefit from income taxes of $1.3 million for the full year 2019.

    For the full year ended December 31, 2020, the Company reported GAAP net loss of $99.6 million, or $12.32 per diluted share, compared to a GAAP net loss for the full year 2019 of $273.0 million, or $34.43 per diluted share.

    Non-GAAP net loss for the full year ended December 31, 2020 was $72.9 million, or $9.02 per diluted share. Non-GAAP net loss for the full year ended December 31, 2019 was $81.8 million, or $10.31 per diluted share. This full year non-GAAP net loss measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, restructuring expenses, changes in the fair value of acquired contingent consideration, asset impairment charges, losses on assets held for sale, gain on extinguishment of debt, and changes in the fair value of derivative liability related to the 2024 convertible notes. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

    At December 31, 2020, the Company had cash, cash equivalents, investments, and restricted cash of $102.9 million. Restricted cash includes $31 million in escrow related to the 6% semi-annual interest portion, payable in cash or stock, of the convertible note exchange completed in December 2019. If the Company elects to pay interest due in stock, the restricted cash will be released from escrow.

    Financial Guidance

    • Operating expenses for the full year 2021 are expected to be $130 - $140 million. This guidance is a non-GAAP projection that excludes restructuring costs and share-based compensation as more fully described below under "Non-GAAP Financial Measures."
    • AMPYRA net revenue for the full year 2021 is expected to be $75-$85 million.

    Recent Highlights

    • In February 2021, the Company announced that it has closed the deal to sell its manufacturing operations in Chelsea, Massachusetts to Catalent. Under the terms of the agreement, Catalent has paid Acorda $80 million in cash, resulting in expected net proceeds to Acorda of approximately $74 million after transaction fees and expenses and settlement of customary post-closing adjustments.
    • In connection with the sale, Acorda and Catalent have entered into a long-term global supply agreement under which Catalent will manufacture and package INBRIJA for Acorda, ensuring an uninterrupted drug supply for Acorda's patients and continued adherence to best-in-class manufacturing quality and safety standards.
    • In January 2021, the Company announced a corporate restructuring, reducing its combined Ardsley, Waltham, and field headcount by approximately 16%.
    • The sale of the manufacturing operations, restructuring and other operating expense reductions are expected to reduce annual operating expenses by approximately $40 million.
    • On December 31, 2020, Acorda implemented a 1-for-6 reverse stock split of the Company's shares of common stock and a proportionate reduction in the number of authorized shares of common stock. This was done to regain compliance with the $1.00 per share minimum closing price required to maintain continued listing on the Nasdaq Global Select Market.

    Webcast and Conference Call

    The Company will host a conference call and webcast in conjunction with its fourth quarter/year end 2020 update and financial results today at 4:30 p.m. EST.

    To participate in the Webcast/Conference Call, please note there is a new pre-registration process.

    **When registering please type your phone number with no special characters**

    A replay of the call will be available from 7:30 p.m. EST on March 4, 2021 until 11:59 p.m. EDT on April 4, 2021. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 9854802. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

    Non-GAAP Financial Measures

    This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP), and also certain historical and forward-looking non-GAAP financial measures. In particular, Acorda has provided non-GAAP net loss, adjusted to exclude the items below, and has provided 2021 operating expense guidance on a non-GAAP basis. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, the Company believes that the presentation of non-GAAP net loss, when viewed in conjunction with actual GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because this measure excludes (i) non-cash compensation charges and benefits that are substantially dependent on changes in the market price of our common stock, (ii) non-cash interest charges related to the accounting for our convertible debt which are in excess of the actual interest expense owing on such convertible debt, as well as non-cash interest related to the Fampyra monetization and acquired Biotie debt, (iii) changes in the fair value of acquired contingent consideration which do not correlate to our actual cash payment obligations in the relevant periods, (iv) asset impairment charges that are not routine to the operation of the business, (v) gain on extinguishment of debt that pertains to an event that is not routine to the operation of the business, (vi) expenses that pertain to our 2019 restructuring, which is not routine to the operation of the business, (vii) changes in the fair value of derivative liability relating to the 2024 convertible notes, which is a non-cash charge and not related to the operation of the business, and (viii) losses on assets held for sale that pertain to a non-routine sale of manufacturing operations. The Company believes its non-GAAP net loss measure helps indicate underlying trends in the Company's business and is important in comparing current results with prior period results and understanding projected operating performance. Also, management uses this non-GAAP financial measure to establish budgets and operational goals, and to manage the Company's business and to evaluate its performance.

    In addition to non-GAAP net loss, we have provided 2021 operating expense guidance on a non-GAAP basis, as the guidance excludes restructuring costs and share-based compensation charges. Due to the forward looking nature of this information, the amount of compensation charges needed to reconcile these measures to the most directly comparable GAAP financial measures is dependent on future changes in the market price of our common stock and is not available at this time. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, the Company believes that the presentation of this non-GAAP financial measure, when viewed in conjunction with actual GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because it excludes (i) expenses that pertain to non-routine restructuring events, and (ii) non-cash charges that are substantially dependent on changes in the market price of our common stock. We believe this non-GAAP financial measure helps indicate underlying trends in the Company's business and is important in comparing current results with prior period results and understanding expected operating performance. Also, management uses this non-GAAP financial measure to establish budgets and operational goals, and to manage the Company's business and to evaluate its performance.

    About Acorda Therapeutics

    Acorda Therapeutics develops therapies to restore function and improve the lives of people with neurological disorders. INBRIJA is approved for intermittent treatment of OFF episodes in adults with Parkinson's disease treated with carbidopa/levodopa. INBRIJA is not to be used by patients who take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last two weeks. INBRIJA utilizes Acorda's innovative ARCUS® pulmonary delivery system, a technology platform designed to deliver medication through inhalation. Acorda also markets the branded AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg.

    Forward-Looking Statements

    This press release includes forward-looking statements. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including: we may not be able to successfully market AMPYRA, INBRIJA or any other products under development; the COVID-19 pandemic, including related quarantines and travel restrictions, and the potential for the illness to affect our employees or consultants or those that work for other companies we rely upon, could have a material adverse effect on our business operations or product sales; our ability to raise additional funds to finance our operations, repay outstanding indebtedness or satisfy other obligations, and our ability to control our costs or reduce planned expenditures; risks associated with the trading of our common stock and our reverse stock split; risks related to our workforce, including our ability to realize the expected benefits of our corporate restructuring; risks associated with complex, regulated manufacturing processes for pharmaceuticals, which could affect whether we have sufficient commercial supply of INBRIJA to meet market demand; our reliance on third-party manufacturers for the production of commercial supplies of AMPYRA and INBRIJA; third party payers (including governmental agencies) may not reimburse for the use of INBRIJA or our other products at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; competition for INBRIJA, AMPYRA and other products we may develop and market in the future, including increasing competition and accompanying loss of revenues in the U.S. from generic versions of AMPYRA (dalfampridine) following our loss of patent exclusivity; the ability to realize the benefits anticipated from acquisitions, among other reasons because acquired development programs are generally subject to all the risks inherent in the drug development process and our knowledge of the risks specifically relevant to acquired programs generally improves over time; the risk of unfavorable results from future studies of INBRIJA (levodopa inhalation powder) or from our other research and development programs, or any other acquired or in-licensed programs; the occurrence of adverse safety events with our products; the outcome (by judgment or settlement) and costs of legal, administrative or regulatory proceedings, investigations or inspections, including, without limitation, collective, representative or class action litigation; failure to protect our intellectual property, to defend against the intellectual property claims of others or to obtain third party intellectual property licenses needed for the commercialization of our products; and failure to comply with regulatory requirements could result in adverse action by regulatory agencies.

    These and other risks are described in greater detail in our filings with the Securities and Exchange Commission. We may not actually achieve the goals or plans described in our forward-looking statements, and investors should not place undue reliance on these statements. Forward-looking statements made in this press release are made only as of the date hereof, and we disclaim any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

    Financial Statements

    Acorda Therapeutics, Inc.

    Condensed Consolidated Balance Sheet Data

    (in thousands)

     

    December 30,

     

     

    December 31,

     

     

    2020

     

     

    2019

     

     

    (unaudited)

     

     

     

     

     

    Assets

     

     

     

     

     

     

     

    Cash, cash equivalents and short-term investments

    $

    71,369

     

     

    $

    125,839

     

    Restricted cash - short term

     

    12,917

     

     

     

    12,836

     

    Trade receivable, net

     

    20,193

     

     

     

    22,083

     

    Other current assets

     

    16,384

     

     

     

    15,134

     

    Inventories, net

     

    28,677

     

     

     

    25,221

     

    Assets held for sale - current

     

    71,795

     

     

     

     

    Property and equipment, net

     

    7,263

     

     

     

    142,527

     

    Intangible assets, net

     

    366,981

     

     

     

    402,329

     

    Restricted cash - long term

     

    18,609

     

     

     

    30,270

     

    Right of use assets, net

     

    18,481

     

     

     

    23,450

     

    Other assets

     

    11

     

     

     

    29

     

    Total assets

    $

    632,680

     

     

    $

    799,718

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Liabilities and stockholders' equity

     

     

     

     

     

     

     

    Accounts payable, accrued expenses and other current liabilities

    $

    50,322

     

     

    $

    65,335

     

    Current portion of lease liability

     

    7,944

     

     

     

    7,746

     

    Current portion of royalty liability

     

    8,731

     

     

     

    10,836

     

    Current portion of contingent consideration

     

    1,624

     

     

     

    1,866

     

    Current portion of loans payable

     

    68,631

     

     

     

    603

     

    Convertible senior notes non-current

     

    137,619

     

     

     

    192,774

     

    Derivative liability related to conversion option

     

    1,193

     

     

     

    59,409

     

    Non-current portion of acquired contingent consideration

     

    46,576

     

     

     

    78,434

     

    Non-current portion of lease liability

     

    17,200

     

     

     

    22,995

     

    Non-current portion of royalty liability

     

    6,526

     

     

     

    13,565

     

    Non-current portion of loans payable

     

    28,555

     

     

     

    25,495

     

    Deferred tax liability

     

    19,116

     

     

     

    9,581

     

    Other long-term liabilities

     

    688

     

     

     

    259

     

    Total stockholder's equity

     

    237,955

     

     

     

    310,820

     

    Total liabilities and stockholders' equity

    $

    632,680

     

     

    $

    799,718

     

    Acorda Therapeutics, Inc.

    Consolidated Statements of Operations

    (in thousands, except per share amounts)

    (unaudited)

     

    Three Months Ended

     

     

    Twelve Months Ended

     

     

    December 31,

     

     

    December 31,

     

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Revenues:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Net product revenues

    $

    34,679

     

     

    $

    47,411

     

     

    $

    124,831

     

     

    $

    180,736

     

    Milestone revenues

     

     

     

     

     

     

     

    15,000

     

     

     

     

    Royalty revenues

     

    3,481

     

     

     

    3,086

     

     

     

    13,136

     

     

     

    11,672

     

    Total net revenues

     

    38,160

     

     

     

    50,497

     

     

     

    152,967

     

     

     

    192,408

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Costs and expenses:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Cost of sales

     

    10,842

     

     

     

    8,666

     

     

     

    33,513

     

     

     

    34,849

     

    Research and development

     

    4,323

     

     

     

    9,023

     

     

     

    23,012

     

     

     

    60,083

     

    Selling, general and administrative

     

    32,876

     

     

     

    41,224

     

     

     

    152,576

     

     

     

    192,846

     

    Amortization of intangible assets

     

    7,691

     

     

     

    7,691

     

     

     

    30,763

     

     

     

    25,636

     

    Asset impairment

     

     

     

     

     

     

     

    4,131

     

     

     

    277,561

     

    Loss on assets held for sale

     

    57,896

     

     

     

     

     

     

    57,896

     

     

     

     

    Change in fair value of derivative liability

     

    361

     

     

     

     

     

     

    (39,959

    )

     

     

     

    Change in fair value of acquired

    contingent consideration

     

    2,566

     

     

     

    (30,593

    )

     

     

    (30,889

    )

     

     

    (86,935

    )

    Total operating expenses

     

    116,555

     

     

     

    36,011

     

     

     

    231,043

     

     

     

    504,040

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Operating (loss) income

    $

    (78,395

    )

     

    $

    14,486

     

     

    $

    (78,076

    )

     

    $

    (311,632

    )

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Gain on extinguishment of debt

     

     

     

     

    55,073

     

     

     

     

     

     

    55,073

     

    Other expense, (net)

     

    (7,764

    )

     

     

    (4,697

    )

     

     

    (29,591

    )

     

     

    (17,689

    )

    Loss (income) before income taxes

     

    (86,159

    )

     

     

    64,862

     

     

     

    (107,667

    )

     

     

    (274,248

    )

    Benefit from income taxes

     

    3,111

     

     

     

    798

     

     

     

    8,073

     

     

     

    1,282

     

    Net (loss) income

    $

    (83,048

    )

     

    $

    65,660

     

     

    $

    (99,594

    )

     

    $

    (272,966

    )

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Net (loss) income per common share - basic

    $

    (9.82

    )

     

    $

    8.27

     

     

    $

    (12.32

    )

     

    $

    (34.43

    )

    Net (loss) income per common share - diluted

    $

    (9.82

    )

     

    $

    8.26

     

     

    $

    (12.32

    )

     

    $

    (34.43

    )

    Weighted average common shares - basic

     

    8,454

     

     

     

    7,938

     

     

     

    8,084

     

     

     

    7,927

     

    Weighted average common shares - diluted

     

    8,454

     

     

     

    7,947

     

     

     

    8,084

     

     

     

    7,927

     

    Acorda Therapeutics, Inc.

    Non-GAAP Net (Loss) Income and Net (Loss) Income per Common Share Reconciliation

    (in thousands, except per share amounts)

    (unaudited)

     

    Three Months Ended

     

     

    Twelve Months Ended

     

     

    December 31,

     

     

    December 31,

     

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    GAAP net (loss) income

    $

    (83,048

    )

     

    $

    65,660

     

     

    $

    (99,594

    )

     

    $

    (272,966

    )

    Pro forma adjustments:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Non-cash interest expense (1)

     

    4,203

     

     

     

    3,522

     

     

     

    16,422

     

     

     

    15,724

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Change in fair value of acquired

    contingent consideration (2)

     

    2,566

     

     

     

    (30,593

    )

     

     

    (30,889

    )

     

     

    (86,935

    )

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Restructuring costs (3)

     

     

     

     

    4,401

     

     

     

    343

     

     

     

    4,401

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Loss on assets held for sale (4)

     

    57,896

     

     

     

     

     

     

    57,896

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Asset impairment charge (5)

     

     

     

     

     

     

     

    4,131

     

     

     

    277,561

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Loss (gain) on change in fair value

    of derivative liability (6)

     

    361

     

     

     

     

     

     

    (39,959

    )

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Gain on extinguishment of debt (7)

     

     

     

     

    (55,073

    )

     

     

     

     

     

    (55,073

    )

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Share-based compensation expenses

    included in Cost of Sales

     

    75

     

     

     

    118

     

     

     

    335

     

     

     

    624

     

    Share-based compensation expenses

    included in R&D

     

    327

     

     

     

    609

     

     

     

    1,745

     

     

     

    2,812

     

    Share-based compensation expenses

    included in SG&A

     

    1,187

     

     

     

    2,029

     

     

     

    6,020

     

     

     

    10,814

     

    Total share-based compensation expenses

     

    1,589

     

     

     

    2,756

     

     

     

    8,100

     

     

     

    14,250

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Total pro forma adjustments

     

    66,615

     

     

     

    (74,987

    )

     

     

    16,045

     

     

     

    169,928

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Income tax effect of reconciling items above (8)

     

    4,698

     

     

     

    (2,264

    )

     

     

    (10,634

    )

     

     

    (21,284

    )

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Non-GAAP net loss

    $

    (21,131

    )

     

    $

    (7,063

    )

     

    $

    (72,915

    )

     

    $

    (81,754

    )

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Net loss per common share - basic and diluted

    $

    (2.50

    )

     

    $

    (0.89

    )

     

    $

    (9.02

    )

     

    $

    (10.31

    )

    Weighted average common shares - basic and diluted

     

    8,454

     

     

     

    7,938

     

     

     

    8,084

     

     

     

    7,927

     

    (1)

    Non-cash interest expense related to convertible senior notes, Biotie non-convertible and R&D loans and Fampyra royalty monetization.

    (2)

    Changes in fair value of acquired contingent consideration related to the Civitas acquisition.

    (3)

    Costs associated with the 2019 corporate restructuring.

    (4)

    Impairment loss on Chelsea manufacturing assets held for sale at December 31, 2020.

    (5)

    Charges related to the 2020 impairment of BTT1023 acquired in the Biotie acquisition and the 2019 impairment of goodwill associated with the Civitas and Biotie acquisitions.

    (6)

    Changes in the fair value of the derivative liability related to the 2024 convertible senior notes.

    (7)

    Gain on December 2019 extinguishment of a portion of the convertible senior notes due June 2021.

    (8)

    Represents the tax effect of the non-GAAP adjustments.

     

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  2. Acorda Therapeutics, Inc. (NASDAQ:ACOR) will host a conference call and webcast in conjunction with its fourth quarter and year end 2020 update and financial results on Thursday, March 4 at 4:30 p.m. ET.

    To participate in the Webcast/Conference Call, please note there is a new pre-registration process.

    Once you have registered, you will receive a confirmation email with Webcast/Conference Call details. For the Webcast you will receive…

    Acorda Therapeutics, Inc. (NASDAQ:ACOR) will host a conference call and webcast in conjunction with its fourth quarter and year end 2020 update and financial results on Thursday, March 4 at 4:30 p.m. ET.

    To participate in the Webcast/Conference Call, please note there is a new pre-registration process.

    Once you have registered, you will receive a confirmation email with Webcast/Conference Call details. For the Webcast you will receive an email 2 hours prior to the start of the call with the link to join. The presentation will be available on the Investors section of www.acorda.com.

    A replay of the call will be available from 7:30 p.m. ET on March 4, 2021 until 11:59 p.m. ET on April 3, 2021. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 9854802. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

    About Acorda Therapeutics

    Acorda Therapeutics develops therapies to restore function and improve the lives of people with neurological disorders. INBRIJA® (levodopa inhalation powder) is approved for intermittent treatment of OFF episodes in adults with Parkinson's disease treated with carbidopa/levodopa. INBRIJA is not to be used by patients who take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last two weeks. INBRIJA utilizes Acorda's innovative ARCUS® pulmonary delivery system, a technology platform designed to deliver medication through inhalation. Acorda also markets the branded AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg.

    Forward-Looking Statements

    This press release includes forward-looking statements. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including: we may not be able to successfully market AMPYRA, INBRIJA or any other products under development; the COVID-19 pandemic, including related quarantines and travel restrictions, and the potential for the illness to affect our employees or consultants or those that work for other companies we rely upon, could have a material adverse effect on our business operations or product sales; our ability to raise additional funds to finance our operations, repay outstanding indebtedness or satisfy other obligations, and our ability to control our costs or reduce planned expenditures and take other actions which are necessary for us to continue as a going concern; risks associated with the trading of our common stock and our reverse stock split; risks related to our workforce, including our ability to realize the expected benefits of our corporate restructuring; risks associated with complex, regulated manufacturing processes for pharmaceuticals, which could affect whether we have sufficient commercial supply of INBRIJA to meet market demand; our reliance on third-party manufacturers for the production of commercial supplies of AMPYRA and INBRIJA; third party payers (including governmental agencies) may not reimburse for the use of INBRIJA or our other products at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; competition for INBRIJA, AMPYRA and other products we may develop and market in the future, including increasing competition and accompanying loss of revenues in the U.S. from generic versions of AMPYRA (dalfampridine) following our loss of patent exclusivity; the ability to realize the benefits anticipated from acquisitions, among other reasons because acquired development programs are generally subject to all the risks inherent in the drug development process and our knowledge of the risks specifically relevant to acquired programs generally improves over time; the risk of unfavorable results from future studies of INBRIJA (levodopa inhalation powder) or from our other research and development programs, or any other acquired or in-licensed programs; the occurrence of adverse safety events with our products; the outcome (by judgment or settlement) and costs of legal, administrative or regulatory proceedings, investigations or inspections, including, without limitation, collective, representative or class action litigation; failure to protect our intellectual property, to defend against the intellectual property claims of others or to obtain third party intellectual property licenses needed for the commercialization of our products; and failure to comply with regulatory requirements could result in adverse action by regulatory agencies.

    These and other risks are described in greater detail in our filings with the Securities and Exchange Commission. We may not actually achieve the goals or plans described in our forward-looking statements, and investors should not place undue reliance on these statements. Forward-looking statements made in this press release are made only as of the date hereof, and we disclaim any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this presentation.

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  3. Acorda Therapeutics, Inc. (NASDAQ:ACOR) today announced that David Lawrence, Chief, Business Operations and its principal accounting and financial officer, is resigning from the Company effective mid-March, 2021. Mr. Lawrence will take a leadership position at an early-stage biotechnology company.

    "Dave has been an important part of Acorda's leadership team over the past 22 years and we are grateful for the many contributions he has made to the Company," said Ron Cohen, Acorda's President and CEO. "While we will miss him, we support his interest in exploring a new phase of his career, and wish him well in his next opportunity."

    "I am proud to have been part of helping Acorda grow from a small, private company to a public, commercial company…

    Acorda Therapeutics, Inc. (NASDAQ:ACOR) today announced that David Lawrence, Chief, Business Operations and its principal accounting and financial officer, is resigning from the Company effective mid-March, 2021. Mr. Lawrence will take a leadership position at an early-stage biotechnology company.

    "Dave has been an important part of Acorda's leadership team over the past 22 years and we are grateful for the many contributions he has made to the Company," said Ron Cohen, Acorda's President and CEO. "While we will miss him, we support his interest in exploring a new phase of his career, and wish him well in his next opportunity."

    "I am proud to have been part of helping Acorda grow from a small, private company to a public, commercial company that has brought important new therapies to people living with neurological conditions, including Parkinson's and multiple sclerosis," said Mr. Lawrence. "Following our recently announced improvements to Acorda's financial structure, I am leaving the company in an excellent position, and will be cheering it on to continued success."

    Robert Morales, Acorda's Vice President of Finance and Controller, will assume the roles of interim principal accounting officer and interim principal financial officer.

    About Acorda Therapeutics

    Acorda Therapeutics develops therapies to restore function and improve the lives of people with neurological disorders. INBRIJA is approved for intermittent treatment of OFF episodes in adults with Parkinson's disease treated with carbidopa/levodopa. INBRIJA is not to be used by patients who take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last two weeks. INBRIJA utilizes Acorda's innovative ARCUS® pulmonary delivery system, a technology platform designed to deliver medication through inhalation. Acorda also markets the branded AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg.

    Forward-Looking Statements

    This press release includes forward-looking statements. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including: we may not be able to successfully market AMPYRA, INBRIJA or any other products under development; the COVID-19 pandemic, including related quarantines and travel restrictions, and the potential for the illness to affect our employees or consultants or those that work for other companies we rely upon, could have a material adverse effect on our business operations or product sales; our ability to raise additional funds to finance our operations, repay outstanding indebtedness or satisfy other obligations, and our ability to control our costs or reduce planned expenditures and take other actions which are necessary for us to continue as a going concern; risks associated with the trading of our common stock and our reverse stock split; risks related to our workforce, including our ability to realize the expected benefits of our corporate restructuring; risks associated with complex, regulated manufacturing processes for pharmaceuticals, which could affect whether we have sufficient commercial supply of INBRIJA to meet market demand; our reliance on third-party manufacturers for the production of commercial supplies of AMPYRA and INBRIJA; third party payers (including governmental agencies) may not reimburse for the use of INBRIJA or our other products at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; competition for INBRIJA, AMPYRA and other products we may develop and market in the future, including increasing competition and accompanying loss of revenues in the U.S. from generic versions of AMPYRA (dalfampridine) following our loss of patent exclusivity; the ability to realize the benefits anticipated from acquisitions, among other reasons because acquired development programs are generally subject to all the risks inherent in the drug development process and our knowledge of the risks specifically relevant to acquired programs generally improves over time; the risk of unfavorable results from future studies of INBRIJA (levodopa inhalation powder) or from our other research and development programs, or any other acquired or in-licensed programs; the occurrence of adverse safety events with our products; the outcome (by judgment or settlement) and costs of legal, administrative or regulatory proceedings, investigations or inspections, including, without limitation, collective, representative or class action litigation; failure to protect our intellectual property, to defend against the intellectual property claims of others or to obtain third party intellectual property licenses needed for the commercialization of our products; and failure to comply with regulatory requirements could result in adverse action by regulatory agencies.

    These and other risks are described in greater detail in our filings with the Securities and Exchange Commission. We may not actually achieve the goals or plans described in our forward-looking statements, and investors should not place undue reliance on these statements. Forward-looking statements made in this press release are made only as of the date hereof, and we disclaim any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

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  4. Acorda Therapeutics, Inc. (NASDAQ:ACOR) today announced that it has completed the sale of its manufacturing operations in Chelsea, Massachusetts to Catalent. Under the terms of the agreement, Catalent has paid Acorda $80 million in cash, resulting in expected net proceeds to Acorda of approximately $74 million after transaction fees and expenses and settlement of customary post-closing adjustments. In connection with the sale, Acorda and Catalent have entered into a long-term global supply agreement under which Catalent will manufacture and package INBRIJA for Acorda, ensuring an uninterrupted drug supply for Acorda's patients and continued adherence to best-in-class manufacturing quality and safety standards.

    About Acorda Therapeutics

    Acorda…

    Acorda Therapeutics, Inc. (NASDAQ:ACOR) today announced that it has completed the sale of its manufacturing operations in Chelsea, Massachusetts to Catalent. Under the terms of the agreement, Catalent has paid Acorda $80 million in cash, resulting in expected net proceeds to Acorda of approximately $74 million after transaction fees and expenses and settlement of customary post-closing adjustments. In connection with the sale, Acorda and Catalent have entered into a long-term global supply agreement under which Catalent will manufacture and package INBRIJA for Acorda, ensuring an uninterrupted drug supply for Acorda's patients and continued adherence to best-in-class manufacturing quality and safety standards.

    About Acorda Therapeutics

    Acorda Therapeutics develops therapies to restore function and improve the lives of people with neurological disorders. INBRIJA® (levodopa inhalation powder) is approved for intermittent treatment of OFF episodes in adults with Parkinson's disease treated with carbidopa/levodopa. INBRIJA is not to be used by patients who take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last two weeks. INBRIJA utilizes Acorda's innovative ARCUS® pulmonary delivery system, a technology platform designed to deliver medication through inhalation. Acorda also markets the branded AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg.

    Forward-Looking Statements

    This press release includes forward-looking statements. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including: we may not be able to successfully market AMPYRA, INBRIJA or any other products under development; the COVID-19 pandemic, including related quarantines and travel restrictions, and the potential for the illness to affect our employees or consultants or those that work for other companies we rely upon, could have a material adverse effect on our business operations or product sales; our ability to raise additional funds to finance our operations, repay outstanding indebtedness or satisfy other obligations, and our ability to control our costs or reduce planned expenditures and take other actions which are necessary for us to continue as a going concern; risks associated with the trading of our common stock and our reverse stock split; risks related to our workforce, including our ability to realize the expected benefits of our corporate restructuring; risks associated with complex, regulated manufacturing processes for pharmaceuticals, which could affect whether we have sufficient commercial supply of INBRIJA to meet market demand; our reliance on third-party manufacturers for the production of commercial supplies of AMPYRA and INBRIJA; third party payers (including governmental agencies) may not reimburse for the use of INBRIJA or our other products at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; competition for INBRIJA, AMPYRA and other products we may develop and market in the future, including increasing competition and accompanying loss of revenues in the U.S. from generic versions of AMPYRA (dalfampridine) following our loss of patent exclusivity; the ability to realize the benefits anticipated from acquisitions, among other reasons because acquired development programs are generally subject to all the risks inherent in the drug development process and our knowledge of the risks specifically relevant to acquired programs generally improves over time; the risk of unfavorable results from future studies of INBRIJA (levodopa inhalation powder) or from our other research and development programs, or any other acquired or in-licensed programs; the occurrence of adverse safety events with our products; the outcome (by judgment or settlement) and costs of legal, administrative or regulatory proceedings, investigations or inspections, including, without limitation, collective, representative or class action litigation; failure to protect our intellectual property, to defend against the intellectual property claims of others or to obtain third party intellectual property licenses needed for the commercialization of our products; and failure to comply with regulatory requirements could result in adverse action by regulatory agencies.

    These and other risks are described in greater detail in our filings with the Securities and Exchange Commission. We may not actually achieve the goals or plans described in our forward-looking statements, and investors should not place undue reliance on these statements. Forward-looking statements made in this press release are made only as of the date hereof, and we disclaim any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

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  5. Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced it has entered into a definitive agreement to acquire the manufacturing and packaging operations of Acorda Therapeutics, Inc., a developer of therapies to restore function and improve the lives of people with neurological disorders. The acquisition complements Catalent's status as a premier U.S.-based partner for companies across dry powder inhaled dose forms. Completion of the transaction is subject to customary closing conditions and is expected to occur in the first quarter of this calendar year.

    SOMERSET, N.J. (PRWEB) January 13, 2021…

    Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced it has entered into a definitive agreement to acquire the manufacturing and packaging operations of Acorda Therapeutics, Inc., a developer of therapies to restore function and improve the lives of people with neurological disorders. The acquisition complements Catalent's status as a premier U.S.-based partner for companies across dry powder inhaled dose forms. Completion of the transaction is subject to customary closing conditions and is expected to occur in the first quarter of this calendar year.

    SOMERSET, N.J. (PRWEB) January 13, 2021

    Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced it has entered into a definitive agreement to acquire the manufacturing and packaging operations of Acorda Therapeutics, Inc. (NASDAQ:ACOR), a developer of therapies to restore function and improve the lives of people with neurological disorders. The acquisition complements Catalent's status as a premier U.S.-based partner for companies across dry powder inhaled dose forms. Completion of the transaction is subject to customary closing conditions and is expected to occur in the first quarter of this calendar year.

    Under the terms of the agreement, Catalent will acquire Acorda Therapeutics' 90,000 square-foot, FDA-inspected CGMP facility in Chelsea, Massachusetts, close to Boston Logan International Airport and the thriving biotechnology networks centered around Boston and Cambridge. The site operates best-in-class spray drying capacity, including GEA NIRO® PSD-1, PSD-4 and PSD-7 spray drying units, with the latter unit being the largest equipment of its kind in North America, and will provide Catalent with significant commercial-scale capacity for new customer programs. The facility will act as a global center of excellence within the Catalent network for spray-dried dispersion and dry powder encapsulation and packaging. On closing, Acorda Therapeutics' current workforce at the facility will transition employment to Catalent.

    Catalent has also entered into a long-term supply agreement with Acorda Therapeutics to continue commercial manufacture of INBRIJA® (levodopa inhalation powder) from the Chelsea facility. INBRIJA is a prescription medicine from Acorda Therapeutics indicated for use when needed with hypomobility or OFF episodes in adults with Parkinson's disease treated with regular carbidopa/levodopa medicine.

    "Catalent is a premier partner to companies working on multiple forms of inhaled drug delivery, from early-stage development to commercial-scale supply," said Jonathan Arnold, President of Oral and Specialty Delivery at Catalent. "This acquisition complements our existing U.S.-based capabilities in metered-dose and nasal inhalation by adding an experienced team of people and a premier facility enabling us to provide customers with extended capabilities for commercial-scale filling and packaging of dry powder inhalers."

    The Chelsea site will complement and provide downstream capabilities to Catalent's 180,000 square-foot inhalation development facility in Morrisville, Research Triangle Park, North Carolina, which includes development and manufacturing for metered dose inhalers, nasal sprays, and dry powder inhalers. The Morrisville site offers high-speed commercial-scale manufacturing as well as flexible fill lines for clinical-scale and small batch production.

    NIRO® is a registered trademark of GEA Group.

    About Catalent
    Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs around 15,000 people, including approximately 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com

    More products. Better treatments. Reliably supplied.™

    For the original version on PRWeb visit: https://www.prweb.com/releases/catalent_agrees_to_acquire_dry_powder_inhaler_spray_drying_capsule_manufacturing_and_packaging_capabilities_from_acorda_therapeutics/prweb17658599.htm

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  6. SOMERSET, N.J., Jan. 13, 2021 /PRNewswire-PRWeb/ -- Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced it has entered into a definitive agreement to acquire the manufacturing and packaging operations of Acorda Therapeutics, Inc. (NASDAQ:ACOR), a developer of therapies to restore function and improve the lives of people with neurological disorders. The acquisition complements Catalent's status as a premier U.S.-based partner for companies across dry powder inhaled dose forms. Completion of the transaction is subject to customary closing conditions and is expected to occur in the first quarter…

    SOMERSET, N.J., Jan. 13, 2021 /PRNewswire-PRWeb/ -- Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced it has entered into a definitive agreement to acquire the manufacturing and packaging operations of Acorda Therapeutics, Inc. (NASDAQ:ACOR), a developer of therapies to restore function and improve the lives of people with neurological disorders. The acquisition complements Catalent's status as a premier U.S.-based partner for companies across dry powder inhaled dose forms. Completion of the transaction is subject to customary closing conditions and is expected to occur in the first quarter of this calendar year.

    Under the terms of the agreement, Catalent will acquire Acorda Therapeutics' 90,000 square-foot, FDA-inspected CGMP facility in Chelsea, Massachusetts, close to Boston Logan International Airport and the thriving biotechnology networks centered around Boston and Cambridge. The site operates best-in-class spray drying capacity, including GEA NIRO® PSD-1, PSD-4 and PSD-7 spray drying units, with the latter unit being the largest equipment of its kind in North America, and will provide Catalent with significant commercial-scale capacity for new customer programs. The facility will act as a global center of excellence within the Catalent network for spray-dried dispersion and dry powder encapsulation and packaging. On closing, Acorda Therapeutics' current workforce at the facility will transition employment to Catalent.

    Catalent has also entered into a long-term supply agreement with Acorda Therapeutics to continue commercial manufacture of INBRIJA® (levodopa inhalation powder) from the Chelsea facility. INBRIJA is a prescription medicine from Acorda Therapeutics indicated for use when needed with hypomobility or OFF episodes in adults with Parkinson's disease treated with regular carbidopa/levodopa medicine.

    "Catalent is a premier partner to companies working on multiple forms of inhaled drug delivery, from early-stage development to commercial-scale supply," said Jonathan Arnold, President of Oral and Specialty Delivery at Catalent. "This acquisition complements our existing U.S.-based capabilities in metered-dose and nasal inhalation by adding an experienced team of people and a premier facility enabling us to provide customers with extended capabilities for commercial-scale filling and packaging of dry powder inhalers."

    The Chelsea site will complement and provide downstream capabilities to Catalent's 180,000 square-foot inhalation development facility in Morrisville, Research Triangle Park, North Carolina, which includes development and manufacturing for metered dose inhalers, nasal sprays, and dry powder inhalers. The Morrisville site offers high-speed commercial-scale manufacturing as well as flexible fill lines for clinical-scale and small batch production.

    NIRO® is a registered trademark of GEA Group.

    About Catalent

    Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs around 15,000 people, including approximately 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com

    More products. Better treatments. Reliably supplied.™

    Media Contact

    Chris Halling, Catalent, +447580041073,

    Richard Kerns, Northern Exposure Public Relations, +441617285880,

     

    SOURCE Catalent

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  7. HOUSTON, Sept. 17, 2020 (GLOBE NEWSWIRE) -- Aravive, Inc. (NASDAQ:ARAV), a clinical-stage biopharmaceutical company developing transformative therapeutics, today announced that Michael W. Rogers joined the Company's Board of Directors. Mr. Rogers is a biopharmaceutical veteran and healthcare leader with more than 20 years of public company financial experience and will serve as a Chair of the Audit Committee and member on the Board's Business Strategy Committee.

    "Mr. Rogers' extensive management and financial experience should be invaluable as we advance Aravive's clinical programs through development and potential commercialization," said Gail McIntyre, Ph.D., Chief Executive Officer of Aravive. "His expertise in managing financing strategies…

    HOUSTON, Sept. 17, 2020 (GLOBE NEWSWIRE) -- Aravive, Inc. (NASDAQ:ARAV), a clinical-stage biopharmaceutical company developing transformative therapeutics, today announced that Michael W. Rogers joined the Company's Board of Directors. Mr. Rogers is a biopharmaceutical veteran and healthcare leader with more than 20 years of public company financial experience and will serve as a Chair of the Audit Committee and member on the Board's Business Strategy Committee.

    "Mr. Rogers' extensive management and financial experience should be invaluable as we advance Aravive's clinical programs through development and potential commercialization," said Gail McIntyre, Ph.D., Chief Executive Officer of Aravive. "His expertise in managing financing strategies, M&A, out-licensing and royalty transactions at both commercial and development-stage biotechnology companies will bring a unique perspective as we continue to advance AVB-500 and pursue global business development opportunities. We are delighted to welcome him to our Board of Directors."

    Mr. Rogers most recently served as Chief Financial Officer at Aerpio Pharmaceuticals (NASDAQ:ARPO). Prior to Aerpio Pharmaceuticals, he served as CFO at Acorda Therapeutics (NASDAQ:ACOR) and held executive and leadership positions at BG Medicine, Indevus Pharmaceuticals (acquired by Endo Pharmaceuticals), Advanced Health Corporation and Autoimmune. Mr. Rogers currently serves as a member of the Board of Directors for Akebia Therapeutics, with previous advisory experience at Keryx Biopharmaceuticals, Eyepoint Pharmaceuticals and Coronado Biosciences.

    "I am honored to join Aravive's Board at such an exciting time in the company's trajectory," said Mr. Rogers. "I've been fortunate in my career to work alongside teams credited with propelling new and innovative approaches that have transformed the lives of patients and have been impressed by the positive results seen with AVB-500 and its potential to improve outcomes across multiple tumor types. I look forward to partnering with the Aravive management team on the potential pivotal trial strategy for AVB-500 in platinum resistant ovarian cancer."

    Earlier in his career, Mr. Rogers was an investment banker at Lehman Brothers and PaineWebber, where he focused on life sciences companies. He earned his M.B.A. from the Darden School of Business at the University of Virginia and received his bachelor's degree from Union College.

    About Aravive

    Aravive, Inc. is a clinical-stage oncology company developing transformative therapeutics designed to halt the progression of life-threatening diseases. Aravive's lead therapeutic, AVB-500, is an ultra-high affinity decoy protein that targets the GAS6-AXL signaling pathway associated with tumor cell growth. Aravive recently successfully completed a Phase 1b trial of AVB-500 in platinum resistant ovarian cancer and selected 15 mg/kg as the dose for the next potential pivotal trial. Analysis of all safety data to date showed that AVB-500 has been generally well-tolerated with no dose-limiting toxicities or unexpected safety signals. While the Phase 1b trial of AVB-500 in platinum resistant ovarian cancer was a safety trial and not powered to demonstrate efficacy, all 5 patients in the 15 mg/kg cohort experienced clinical benefit, with 1 complete response, 2 partial responses, and 2 stable disease. The Company also intends to initiate a Phase 1b/Phase 2 trial of AVB-500 in clear cell renal cell carcinoma later this year. For more information, please visit www.aravive.com.

    Forward-Looking Statements

    This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended), express or implied, such statements regarding the expected contribution of Mr. Rogers, the potential of AVB-500 to improve outcomes across multiple tumor types, the potential pivotal trial strategy for AVB-500 in platinum resistant ovarian cancer and initiating a Phase 1b/Phase 2 trial of AVB-500 in clear cell renal cell carcinoma later this year. Forward-looking statements are based on current beliefs and assumptions, are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those contained in any forward-looking statement as a result of various factors, including, but not limited to, risks and uncertainties related to: the contribution of Mr. Rogers as a director, our ability to initiate a Phase 1b/Phase 2 trial of AVB-500 in clear cell renal cell carcinoma as scheduled later this year, the impact of COVID-19 on the Company's clinical strategy, clinical trials, supply chain and fundraising, the Company's ability to expand development into additional oncology indications, the Company's dependence upon AVB-500, AVB-500's ability to have favorable results in clinical trials and ISTs, the clinical trials of AVB-500 having results that are as favorable as those of preclinical and clinical trials, the ability to receive regulatory approval, potential delays in the Company's clinical trials due to regulatory requirements or difficulty identifying qualified investigators or enrolling patients especially in light of the COVID-19 pandemic; the risk that AVB-500 may cause serious side effects or have properties that delay or prevent regulatory approval or limit its commercial potential; the risk that the Company may encounter difficulties in manufacturing AVB-500; if AVB-500 is approved, risks associated with its market acceptance, including pricing and reimbursement; potential difficulties enforcing the Company's intellectual property rights; the Company's reliance on its licensor of intellectual property and financing needs. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, recent Current Reports on Form 8-K and subsequent filings with the SEC. Except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

    Contacts:

    Media:

    Sheryl Seapy, W2O



    (213) 262-9390

    Investors:

    Luke Heagle, W2O 



    (910) 726-1372

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  8. NEW YORK, May 6, 2020 /PRNewswire/ -- S&P Dow Jones Indices will make the following changes to the S&P 500, S&P 100, S&P MidCap 400, and S&P SmallCap 600 effective prior to the opening on Tuesday, May 12:

    • DexCom Inc. (NASD:DXCM) will replace Allergan plc (NYSE:AGN) in the S&P 500, and S&P 500 constituent Salesforce.com (NYSE:CRM) will replace Allergan in the S&P 100. S&P 500 and 100 constituent AbbVie Inc. (NYSE:ABBV) is acquiring Allergan in a transaction expected to be completed soon pending final conditions.
    • S&P MidCap 400 constituent Domino's Pizza Inc. (NYSE:DPZ) will replace Capri Holdings Ltd. (NYSE:CPRI) in the S&P 500, STORE Capital Corp. (NYSE:STOR) will replace Domino's Pizza in the S&P MidCap 400, and Capri Holdings will replace…

    NEW YORK, May 6, 2020 /PRNewswire/ -- S&P Dow Jones Indices will make the following changes to the S&P 500, S&P 100, S&P MidCap 400, and S&P SmallCap 600 effective prior to the opening on Tuesday, May 12:

    • DexCom Inc. (NASD:DXCM) will replace Allergan plc (NYSE:AGN) in the S&P 500, and S&P 500 constituent Salesforce.com (NYSE:CRM) will replace Allergan in the S&P 100. S&P 500 and 100 constituent AbbVie Inc. (NYSE:ABBV) is acquiring Allergan in a transaction expected to be completed soon pending final conditions.
    • S&P MidCap 400 constituent Domino's Pizza Inc. (NYSE:DPZ) will replace Capri Holdings Ltd. (NYSE:CPRI) in the S&P 500, STORE Capital Corp. (NYSE:STOR) will replace Domino's Pizza in the S&P MidCap 400, and Capri Holdings will replace Acorda Therapeutics Inc. (NASD:ACOR) in the S&P SmallCap 600. Domino's Pizza is more representative of the large-cap market space. Capri Holdings is more representative of the small-cap market space, and Acorda Therapeutics is no longer appropriate for the SmallCap 600.

    DexCom focuses on the design, development, and commercialization of continuous glucose monitoring systems. Headquartered in San Diego, CA, the company will be added to the S&P 500 GICS (Global Industry Classification Standard) Health Care Equipment Sub-Industry index.

    Salesforce.com develops enterprise cloud computing solutions. The company is headquartered in San Francisco, CA.

    Domino's Pizza operates as a pizza delivery company. Headquartered in Ann Arbor, MI, the company will be added to the S&P 500 GICS Restaurants Sub-Industry index.

    STORE Capital is an internally managed net-lease real estate investment trust (REIT). Headquartered in Scottsdale, AZ, the company will be added to the S&P MidCap 400 GICS Diversified REITs Sub-Industry index.

    Capri Holdings designs, markets, distributes, and retails branded women's and men's apparel and accessories. Headquartered in London, United Kingdom, the company will be added to the S&P SmallCap 600 GICS Apparel, Accessories & Luxury Goods Sub-Industry index.

    Following is a summary of the changes:

    S&P 500 INDEX – May 12, 2020


    COMPANY

    GICS ECONOMIC
    SECTOR

    GICS SUB-INDUSTRY

    ADDED

    DexCom

    Health Care

    Health Care Equipment


    Domino's Pizza

    Consumer Discretionary

    Restaurants

    DELETED

    Allergan

    Health Care

    Pharmaceuticals


    Capri Holdings

     Consumer
    Discretionary

    Apparel Accessories &
    Luxury Goods

     

    S&P 100 INDEX – May 12, 2020


    COMPANY

    GICS ECONOMIC
    SECTOR

    GICS SUB-INDUSTRY

    ADDED

    Salesforce.com

    Information Technology

    Application Software

    DELETED

    Allergan

    Health Care

    Pharmaceuticals

     

    S&P MIDCAP 400 INDEX – May 12, 2020


    COMPANY

    GICS ECONOMIC
    SECTOR

    GICS SUB-INDUSTRY

    ADDED

    STORE Capital

    Real Estate

    Diversified REITs

    DELETED

    Domino's Pizza

    Consumer Discretionary

    Restaurants

     

    S&P SMALLCAP 600 INDEX – May 12, 2020


    COMPANY

    GICS ECONOMIC
    SECTOR

    GICS SUB-INDUSTRY

    ADDED

    Capri Holdings

     Consumer
    Discretionary

    Apparel Accessories &
    Luxury Goods

    DELETED

    Acorda Therapeutics

    Health Care

    Biotechnology

    For more information about S&P Dow Jones Indices, please visit www.spdji.com.

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    S&P Dow Jones Indices is the largest global resource for essential index-based concepts, data and research, and home to iconic financial market indicators, such as the S&P 500® and the Dow Jones Industrial Average®. More assets are invested in products based on our indices than products based on indices from any other provider in the world. Since Charles Dow invented the first index in 1884, S&P DJI has become home to over 1,000,000 indices across the spectrum of asset classes that have helped define the way investors measure and trade the markets.

    S&P Dow Jones Indices is a division of S&P Global (NYSE:SPGI), which provides essential intelligence for individuals, companies, and governments to make decisions with confidence. For more information, visit www.spdji.com.

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    Cision View original content:http://www.prnewswire.com/news-releases/dexcom--dominos-pizza-set-to-join-sp-500-salesforcecom-to-join-sp-100-store-capital-to-join-sp-midcap-400-capri-holdings-to-join-sp-smallcap-600-301054448.html

    SOURCE S&P Dow Jones Indices

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