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AMPYRA 2015 Fourth Quarter Net Sales of $121 Million and 2015
Full-Year Net Sales of $436 Million (Unaudited)
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AMPYRA 2016 Net Sales Guidance of $475-$485 Million
ARDSLEY, N.Y.--(BUSINESS WIRE)--
Acorda Therapeutics, Inc. (Nasdaq:ACOR)
today reported AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg
unaudited net sales for the fourth quarter of 2015 of $121 million.
Unaudited 2015 full-year net sales were $436 million, an increase of
approximately 19% from 2014. Final results are subject to completion of
the Company’s year-end audit.
“We expect a series of important clinical milestones in 2016 for all
three of our late-stage programs,” said Ron Cohen, President and CEO of
Acorda. “We are aiming to complete pivotal trials for CVT-301 in
Parkinson’s disease and PLUMIAZ in seizure clusters this year; if
successful, we plan to file New Drug Applications for both in 2017. We
project that these two therapies could generate combined peak sales of
over $700 million. We also expect to perform an interim analysis in our
Phase 3 trial of dalfampridine for post-stroke walking deficits. This
analysis, combined with results from our development efforts on a
once-daily formulation of dalfampridine, will establish the next steps
for the program.”
Dr. Cohen continued, “AMPYRA’s growth in 2015 allowed us to remain cash
flow positive while still investing in our late stage pipeline. We
expect to remain active on the business development front, focusing on
late stage or marketed products that leverage the strength of our
neurology development and commercial capabilities.”
The Company provided 2016 guidance for AMPYRA net revenue of $475-$485
million, research and development (R&D) expense of $165-$175 million,
and sales, general and administrative (SG&A) expense of $195-$205
million. This guidance excludes share-based compensation.
At year-end 2015, the Company had cash, cash equivalents and investments
of $353 million (unaudited).
This press release includes certain forward-looking financial measures
that were not prepared in accordance with accounting principles
generally accepted in the United States (GAAP). Non-GAAP financial
measures are not an alternative for financial measures prepared in
accordance with GAAP. However, the Company believes the presentation of
these non-GAAP financial measures when viewed in conjunction with our
GAAP results, provide investors with a more meaningful understanding of
our ongoing and projected operating performance. The Company believes
these non-GAAP financial measures help indicate underlying trends in the
company's business and are important in understanding projected
operating performance.
Dr. Cohen will provide a corporate overview today in San Francisco at
the 34th Annual J.P. Morgan Healthcare Conference at 1:30
p.m. Eastern/10:30 a.m. Pacific. The presentation is available via
webcast at www.acorda.com.
About Acorda
Acorda has an industry leading pipeline of novel neurological therapies
addressing a range of disorders, including multiple sclerosis,
Parkinson’s disease, post-stroke walking deficits, epilepsy and
migraine. Acorda markets three FDA-approved therapies, including AMPYRA®
(dalfampridine) Extended Release Tablets, 10 mg.
Forward Looking Statements
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. 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 realize the benefits anticipated from the
Civitas transaction and to successfully integrate Civitas' operations
into our operations; our ability to successfully market and sell 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 CVT-301, Plumiaz, 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, Plumiaz,
or any other products under development; we may need to raise additional
funds to finance our expanded operations and may not be able to do so on
acceptable terms; the occurrence of adverse safety events with our
products; delays in obtaining or failure to obtain regulatory approval
of or to successfully market Fampyra outside of the U.S. and our
dependence on our collaboration partner 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 Acorda
Therapeutics' filings with the Securities and Exchange Commission.
Acorda may not actually achieve the goals or plans described in its
forward-looking statements, and investors should not place undue
reliance on these statements. Forward-looking statements made in this
release are made only as of the date hereof, and Acorda disclaims any
intent or obligation to update any forward-looking statements as a
result of developments occurring after the date of this release.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160111005399/en/
Source: Acorda Therapeutics, Inc.