-
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
ARDSLEY, N.Y.–(BUSINESS WIRE)– 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170109005417/en/
Source: Acorda Therapeutics, Inc.
Cet article Acorda Announces 2016 AMPYRA Net Sales and 2017 Financial Guidance at
J.P. Morgan Healthcare Conference est apparu en premier sur EEI-BIOTECHFINANCES.