Acorda Announces 2016 AMPYRA Net Sales and 2017 Financial Guidance at J.P. Morgan Healthcare Conference
January 09 2017 - 6:00AM
Business Wire
- AMPYRA 2016 Fourth Quarter Net Sales of
$132 Million and 2016 Full-Year Net Sales of $493 Million
(Unaudited)
- AMPYRA 2017 Net Sales Guidance of
$535-$545 Million
Acorda Therapeutics, Inc. (NASDAQ: ACOR) reported AMPYRA®
(dalfampridine) Extended Release Tablets, 10 mg net sales for the
fourth quarter of 2016 of $132 million. Full-year net sales for
2016 were $493 million, an increase of approximately 13% from 2015.
Final results are subject to completion of the Company’s year-end
audit.
“We are on track to announce topline data from our CVT-301 Phase
3 efficacy and long-term safety trials for the treatment of OFF
periods in Parkinson’s disease in the first quarter of 2017,” said
Ron Cohen, President and CEO. “If successful, we plan to file an
NDA in the second quarter of 2017 and an MAA in Europe by the end
of 2017."
“We continue to enroll our Phase 3 study of tozadenant in people
with Parkinson’s and expect topline data from this study in the
first quarter of 2018. Together with CVT-301, these therapies, if
approved, would represent important new treatment options for
people with Parkinson’s.”
“We anticipate rulings on the ANDA and IPR challenges to our
AMPYRA patents during the first quarter. Our corporate priorities
continue to be advancing our CVT-301 and tozadenant Parkinson’s
programs, maximizing the value of our Ampyra franchise and
leveraging business development to partner or out-license some of
our earlier stage programs.”
The Company provided 2017 guidance for AMPYRA net sales of
$535-$545 million, research and development (R&D) expense of
$185-$195 million, and sales, general and administrative (SG&A)
expense of $195-$205 million. These are non-GAAP projections which
exclude share-based compensation, as more fully described below
under “Non-GAAP Financial Measures.”
At year-end 2016, the Company projects cash, cash equivalents
and investments of approximately $155 million (unaudited).
Dr. Cohen will provide a corporate overview today in San
Francisco at the 35th Annual J.P. Morgan Healthcare Conference at
11:30 a.m. Pacific/2:30 p.m. Eastern. The presentation is available
via webcast at www.acorda.com.
Non-GAAP Financial Measures
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). In
particular, Acorda has provided 2017 guidance for R&D and
SG&A expense 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. 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.
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 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.
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 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
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170109005417/en/
Acorda TherapeuticsJeff Macdonald,
914-326-5232jmacdonald@acorda.com
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