Acorda Announces 2015 AMPYRA Sales, 2016 Financial Guidance & 2016/2017 Clinical Milestones at J.P. Morgan Healthcare Confere...
January 11 2016 - 7:30AM
Business Wire
- AMPYRA 2015 Fourth Quarter Net Sales of
$121 Million and 2015 Full-Year Net Sales of $436 Million
(Unaudited)
- AMPYRA 2016 Net Sales Guidance of
$475-$485 Million
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160111005399/en/
Acorda TherapeuticsJeff Macdonald,
914-326-5232jmacdonald@acorda.com
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