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Acorda Provides Financial and Pipeline Update for First Quarter 2017Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced financial results for its first quarter ended March 31, 2017, and provided an update on the Company's pipeline, financial guidance and corporate restructuring. As previously announced, following the decision by the United States District Court for the District of Delaware invalidating certain patents pertaining to AMPYRA®, Acorda implemented a corporate restructuring to reduce its cost structure and focus resources on its late-stage Parkinson's disease programs, CVT-301 and tozadenant. The proposed brand name for CVT-301 is INBRIJA™ (levodopa inhalation powder). The Company expects to maintain exclusivity of AMPYRA at least through July 2018 and plans to appeal the ruling on the invalidated patents. "We acted decisively to reduce expenses within days of the Court's ruling. Moving forward, we will focus on advancing our late-stage Parkinson's programs, INBRIJA and tozadenant," said Ron Cohen, M.D., Acorda's President and CEO. "Our restructuring will enable us to execute these programs on a strong financial footing, and we are confident in the value we will be able to create for shareholders." Acorda's top priorities over the next 12 months are to:
First Quarter 2017 Financial Results AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg - For the quarter ended March 31, 2017, the Company reported AMPYRA net revenue of $112.0 million, up 2% compared to $109.6 million for the same quarter in 2016. ZANAFLEX CAPSULES® (tizanidine hydrochloride), ZANAFLEX® (tizanidine hydrochloride) tablets and authorized generic capsules - For the quarter ended March 31, 2017, the Company reported combined net revenue and royalties from ZANAFLEX and tizanidine of $1.7 million, compared to $1.2 million for the same quarter in 2016. FAMPYRA® (prolonged-release fampridine tablets) - For the quarter ended March 31, 2017, the Company reported FAMPYRA royalties from sales outside of the U.S. of $2.5 million, compared to $2.5 million for the same quarter in 2016. Research and development (R&D) expenses for the quarter ended March 31, 2017 were $46.5 million, including $2.5 million of share-based compensation, compared to $44.6 million, including $2.1 million of share-based compensation, for the same quarter in 2016. Selling, general and administrative (SG&A) expenses for the quarter ended March 31, 2017 were $51.7 million, including $5.3 million of share-based compensation, compared to $51.8 million, including $6.0 million of share-based compensation, for the same quarter in 2016. Benefit from income taxes for the quarter ended March 31, 2017 was $0.9 million, compared to $9.7 million, for the same quarter in 2016. The Company reported a GAAP net loss of $18.9 million for the quarter ended March 31, 2017, or $0.41 per diluted share. The GAAP net loss in the same quarter of 2016 was $0.5 million, or $0.01 per diluted share. Non-GAAP net loss for the quarter ended March 31, 2017 was $3.6 million, or $.08 per diluted share. Non-GAAP net income in the same quarter of 2016 was $12.4 million, or $0.27 per diluted share. This quarterly non-GAAP net income measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, unrealized foreign currency gain, non-cash interest charges on our debt, changes in the fair value of acquired contingent consideration, and acquisition-related expenses. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements. At March 31, 2017, the Company had cash and cash equivalents of $133.6 million. The Company has $345 million of convertible senior notes due in 2021 with a conversion price of $42.56. Corporate Restructuring and 2017 Guidance Update Following the decision by the United States District Court for the District of Delaware invalidating certain patents pertaining to AMPYRA, Acorda implemented a corporate restructuring to reduce its cost structure and focus resources on its late-stage Parkinson's disease programs, INBRIJA and tozadenant.
Pipeline and Corporate Developments
Webcast and Conference Call Acorda will host a conference call today at 8:30 a.m. ET to review first quarter 2017 results. To participate, dial (844) 543-5233 (domestic) or (678) 276-7225 (international) and reference the access code 1387861. The presentation will be available on the Investors section of www.acorda.com. A replay of the call will be available from 11:30 a.m. ET on April 27, 2017 until 11:59 p.m. ET on May 4, 2017. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference the access code 1387861. The archived webcast will be available in the Investor Relations section of the Acorda website. About Acorda Therapeutics Founded in 1995, Acorda Therapeutics is a biopharmaceutical company focused on developing therapies that restore function and improve the lives of people with neurological disorders. Acorda has a pipeline of novel neurological therapies addressing a range of disorders, including Parkinson's disease, migraine and multiple sclerosis. Acorda markets three FDA-approved therapies, including AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg. For more information, please visit the Company's website at: www.acorda.com. Forward-Looking Statement These statements are subject to risks and uncertainties that could cause actual results to differ materially, including: the ability to realize the benefits anticipated from the Biotie and Civitas transactions, 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 ability to successfully integrate Biotie's operations and Civitas' operations, respectively, into our operations; we may need to raise additional funds to finance our expanded operations and may not be able to do so on acceptable terms; our ability to successfully market and sell Ampyra (dalfampridine) Extended Release Tablets, 10 mg in the U.S., which will likely be materially adversely affected by the recently announced court decision in our litigation against filers of Abbreviated New Drug Applications (each, an "ANDA") to market generic versions of Ampyra in the U.S.; third party payers (including governmental agencies) may not reimburse for the use of Ampyra or our other products at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; the risk of unfavorable results from future studies of Ampyra or from our other research and development programs, including INBRIJA (our trade name for CVT-301), or any other acquired or in-licensed programs; we may not be able to complete development of, obtain regulatory approval for, or successfully market INBRIJA, any other products under development, or the products that we acquired with the Biotie transaction; the occurrence of adverse safety events with our products; delays in obtaining or failure to obtain and maintain regulatory approval of or to successfully market Fampyra outside of the U.S. and our dependence on our collaborator Biogen in connection therewith; competition; 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. 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 income, adjusted to exclude the items below, and has provided 2017 guidance for R&D and SG&A 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 the presentation of non-GAAP net income, when viewed in conjunction with our GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because this measure excludes (i) non-cash 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 outstanding convertible debt which are in excess of the actual interest expense owing on such convertible debt as well as non-cash interest charges related to our asset based loan 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 period, (iv) unrealized foreign currency gain related to the Biotie acquisition, (v) acquisition related expenses that pertain to a non-recurring event, and (vi) corporate restructuring expenses that pertain to a non-recurring event. The Company believes its non-GAAP net income 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 income, we have provided revised 2017 guidance for R&D and SG&A on a non-GAAP basis. Due to the forward looking nature of this information, the amount of compensation charges and benefits 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. The Company believes that these non-GAAP measures, when viewed in conjunction with our GAAP results, provide investors with a more meaningful understanding of our ongoing and projected R&D and SG&A expenses. Also, management uses these non-GAAP financial measures to establish budgets and operational goals, and to manage the Company's business and to evaluate its performance. Financial Statements
Note: Non-GAAP net income per share basic and diluted as presented above were also revised as a result of the changes to the income tax effect of the non-GAAP adjustments as noted above.
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