Acorda Provides Financial and Pipeline Update for Second Quarter 2016

ARDSLEY, N.Y.–(BUSINESS WIRE)– Acorda Therapeutics, Inc. (Nasdaq:ACOR)
today provided a financial and pipeline update for the second quarter
ended June 30, 2016.

“AMPYRA’s continued growth is fueling investment in our late stage
pipeline. We expect several important milestones in the second half of
2016 and early 2017, including data from our Phase 3 dalfampridine
post-stroke and CVT-301 trials. These near-term opportunities target
large, unmet needs and have the potential to improve the lives of people
with these serious neurological diseases,” said Ron Cohen, M.D.,
Acorda’s President and CEO. “We are working towards concluding our
acquisition of Biotie later this year and excited about the addition of
the tozadenant Phase 3 program to our pipeline of late stage assets.”

Financial Results

The Company reported a GAAP net loss attributable to Acorda of $18.3
million for the quarter ended June 30, 2016, or $0.40 per diluted share.
GAAP net income in the same quarter of 2015 was $1.0 million, or $0.02
per diluted share.

Non-GAAP net income for the quarter ended June 30, 2016, was $3.4
million, or $0.07 per diluted share. Non-GAAP net income in the same
quarter of 2015 was $13.5 million, or $0.31 per diluted share. Non-GAAP
net income excludes share based compensation charges, non-cash interest
expense, acquisition-related expenses, expenses associated with changes
in the fair value of acquired contingent consideration, foreign currency
losses/(gains) and tax adjustments. A reconciliation of the GAAP
financial results to non-GAAP financial results is included in the
attached financial statements.

AMPYRA^® (dalfampridine) Extended Release Tablets, 10 mg – For
the quarter ended June 30, 2016, the Company reported AMPYRA net revenue
of $122.1 million compared to $105.5 million for the same quarter in
2015.

ZANAFLEX CAPSULES^® (tizanidine hydrochloride), ZANAFLEX^®
(tizanidine hydrochloride) tablets and authorized generic capsules – For
the quarter ended June 30, 2016, the Company reported combined net
revenue and royalties from ZANAFLEX and tizanidine of $(0.7) million
compared to $3.2 million for the same quarter in 2015. Combined net
revenue and royalties for the period ended June 30, 2016, includes a
charge of $3.0 million due to an increase in current and estimated
future returns for ZANAFLEX.

FAMPYRA^® (prolonged-release fampridine tablets) – For the
quarter ended June 30, 2016, the Company reported FAMPYRA royalties from
sales outside of the U.S. of $2.7 million compared to $2.5 million for
the same quarter in 2015.

Research and development (R&D) expenses for the quarter ended June 30,
2016, were $50.3 million, including $2.6 million of share-based
compensation, compared to $31.2 million, including $2.2 million of
share-based compensation for the same quarter in 2015. R&D expenses
increased due to investment in our late stage programs, as well as the
addition of Biotie R&D expenses from the date of acquisition.

Sales, general and administrative (SG&A) expenses for the quarter ended
June 30, 2016, were $53.1 million, including $6.7 million of share-based
compensation, compared to $52.8 million, including $6.5 million of
share-based compensation for the same quarter in 2015. SG&A expenses
exclude transaction expenses related to the Biotie acquisition and
include Biotie expenses for the quarter ended June 30, 2016, from the
date of acquisition.

Benefit from income taxes for the quarter ended June 30, 2016, was $1.0
million, including $2.4 million of cash taxes, compared to a provision
for income taxes of $1.1 million, including $0.6 million of cash taxes,
for the same quarter in 2015.

At June 30, 2016, the Company had cash, cash equivalents and investments
of $137.4 million. The decrease in cash from December 31, 2015, is
primarily attributable to the Company’s acquisition of Biotie. In June
2016, the Company entered into a three-year senior secured revolving
credit agreement with JP Morgan Chase Bank, N.A. for up to $60 million.

2016 Financial Guidance

• The Company reiterates AMPYRA 2016 net sales guidance of $475-$485
  million.
• R&D guidance is revised from $165-$175 million to $195-$205 million.
  This guidance is a non-GAAP projection which excludes share-based
  compensation, as more fully described below under “Non-GAAP Financial
  Measures.” The increase in R&D expense is primarily driven by the
  addition of tozadenant, a Phase 3 asset for the treatment of OFF
  periods for people with Parkinson’s disease.
• SG&A guidance remains unchanged at $195-$205 million. This guidance is
  a non-GAAP projection which excludes share-based compensation for the
  Company and transaction expenses related to the Biotie acquisition, as
  more fully described below under “Non-GAAP Financial Measures.” SG&A
  guidance reflects the addition of the Biotie operations, offset by
  reductions in current and projected SG&A expenses.
• The Company expects to be approximately cash flow neutral for the
  second half of 2016.

Second Quarter 2016 Highlights

Commercial

• AMPYRA^® (dalfampridine)
  • AMPYRA revenues for the second quarter of 2016 were $122.1
    million, up 16% from the second quarter in 2015. This represents
    the 13^th consecutive quarter of double-digit,
    year-over-year growth for AMPYRA, which was launched in 2010.
  • In June, the United States Court of Appeals for the Federal
    Circuit denied a request by Mylan Pharmaceuticals for a rehearing
    of the Court’s previous decision to uphold a lower court ruling
    that Acorda’s Abbreviated New Drug Application (ANDA) litigation
    against Mylan can continue in the District Court of Delaware.
    Mylan has indicated that it intends to file a petition for
    certiorari to the United States Supreme Court.
  • In July, the Company submitted its responses to four Inter Partes
    Review (IPR) petitions to the United States Patent and Trademark
    Office (USPTO). A decision on the IPR is expected in March 2017.
  • A District Court trial for Company’s litigation against six
    generic companies seeking ANDA approvals is scheduled for
    September 2016. The Company has five Orange Book-listed patents on
    AMPYRA and will vigorously defend its intellectual property rights.

Late Stage Clinical Pipeline

• Dalfampridine in Post-Stroke Walking Difficulties (PSWD)
  • Data from an unblinded analysis of the current twice-daily (BID)
    clinical trial are expected in the fourth quarter of 2016. Data
    from the Phase 1 multi-dose pharmacokinetic (PK) testing for
    once-daily (QD) dalfampridine are also expected in the fourth
    quarter of 2016.
  • If the multi-dose PK and BID analyses are positive, the Company
    plans to move forward with two concurrent, pivotal Phase 3 trials
    of dalfampridine in PSWD in mid-2017 using a QD formulation.
• CVT-301 in Parkinson’s Disease
  • In June, data from the CVT-301 Phase 2b clinical trial were
    presented in three posters during the 20th International Congress
    of Parkinson’s Disease and Movement Disorders in Berlin, Germany.
  • Last patient out (LPO) of the ongoing Phase 3 efficacy study is
    expected by the end of 2016.

Early Stage Pipeline

• CVT-427 in Migraine
  • Data from a Phase 1 pharmacokinetic (PK) study of CVT-427, an
    inhaled formulation of zolmitriptan, showed increased
    bioavailability and faster absorption compared to oral and nasal
    administration of the same active ingredient. The trial enrolled
    21 healthy adults.
  • The data showed that median TMAX was about 12 minutes for all
    CVT-427 doses compared to 1.5 hours for the oral tablet and 3.0
    hours for the nasal spray.
  • There were no serious adverse events, dose limiting toxicities, or
    study discontinuations due to adverse events reported after
    administration. The most commonly reported treatment-emergent AEs
    were cough, chest discomfort, headache and feeling hot. Apart from
    cough, single dose CVT-427 tolerability was generally consistent
    with the known safety profile of zolmitriptan.
  • The data were presented at the 58th Annual Scientific Meeting of
    the American Headache Society in San Diego, CA.
  • The Company plans to initiate a special population study in the
    second half of 2016, and expects to advance this program into
    Phase 2 in 2017.
• Other Pipeline
  • In May, development of PLUMIAZ^TM, an investigational
    therapy for the treatment of seizure clusters in people with
    epilepsy, was discontinued after data from the Phase 3 clinical
    trials did not demonstrate its bioequivalence to Diastat^®
    (diazepam) rectal gel.

Corporate Updates

• The Company has received more than 97% of Biotie’s outstanding shares
  in the tender offer and expects to complete the purchase of 100% of
  Biotie’s shares in the second half of this year.
• In June, Biotie delisted its American Depositary Shares from the
  NASDAQ following the filing of an application on Form 25 with the U.S.
  Securities and Exchange Commission.
• In July, Dr. Burkhard Blank assumed the role of Chief Medical Officer
  (CMO). Dr. Blank was named interim CMO in January 2016, and previously
  served as CMO for several biopharmaceutical companies, including
  Boehringer Ingelheim, Inc.

Webcast and Conference Call

The Company will host a conference call today at 8:30 a.m. ET to review
its second quarter 2016 results.

To participate in the conference call, please dial (855) 542-4209
(domestic) or (412) 455-6054 (international) and reference the access
code 40809722. The presentation will be available on the Investors
section of www.acorda.com.
Please log in approximately 5 minutes before the scheduled time of the
presentation to ensure a timely connection.

A replay of the call will be available from 11:30 a.m. ET on July 28,
2016, until 11:59 p.m. ET on August 4, 2016. To access the replay,
please dial (855) 859-2056 (domestic) or (404) 537-3406 (international)
and reference the access code 40809722. 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 biotechnology company focused
on developing therapies that restore function and improve the lives of
people with neurological disorders.

Acorda has an pipeline of novel neurological therapies addressing a
range of disorders, including Parkinson’s disease, post-stroke walking
difficulties, 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

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: the
ability to complete the Biotie transaction on a timely basis; 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.; 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
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 CVT-301, any other products under development, or
the products that we will acquire when we complete 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 presentation 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.

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 2016
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,
provide 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) non-cash
tax expenses related to our tax accounting which do not correlate to our
actual tax payment obligations, (v) realized foreign currency
transaction gains and losses, and (vi) acquisition related expenses. 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 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 2016
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
range of SG&A expenditures for 2016 also excludes expenses related to
the acquisition of Biotie because of the extraordinary nature of these
expenses. The Company believes that this non-GAAP measure provides
investors with a more meaningful understanding of our ongoing and
projected SG&A expenses.

A reconciliation of the historical non-GAAP financial results presented
in this release to our GAAP financial results (but not the 2016 guidance
for R&D and SG&A) is included in the attached financial statements.

Financial Statements

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