Acorda Therapeutics Provides Corporate Update at 31st Annual J.P. Morgan Healthcare Conference
Acorda Therapeutics, Inc. (Nasdaq: ACOR)
today announced that AMPYRA® (dalfampridine) Extended Release
Tablets, 10 mg unaudited net sales for the fourth quarter of 2012 were
$73 million and unaudited AMPYRA 2012 full-year net sales were $266
million. These results are subject to completion of the Company’s
year-end audit.
The Company provided 2013 guidance for AMPYRA net sales revenue of
$285-$315 million. Guidance for Zanaflex® (tizanidine
hydrochloride) and ex-U.S. FAMPYRA revenue is $25 million, which
includes sales of branded Zanaflex products, royalties from ex-U.S.
FAMPYRA and authorized generic tizanidine hydrochloride capsules sales,
and $9.1 million in amortized licensing revenue from the $110 million
payment the Company received from Biogen Idec in 2009 for FAMPYRA
ex-U.S. development and commercialization rights.
Guidance for 2013 sales, general and administrative (SG&A) expense is
$170-$180 million and 2013 research and development (R&D) expense is
$60-$70 million. The increase in SG&A and R&D expenses in 2013 over 2012
is primarily related to research and commercialization expenses for the
recently acquired product Diazepam Nasal Spray.
Based on this guidance, the Company expects to be cash flow positive in
2013.
President and CEO Ron Cohen, M.D. will provide a corporate overview,
including the Company’s recent acquisition of Diazepam Nasal Spray, at
the 31st Annual J.P. Morgan Healthcare Conference today at
11:00 a.m. Pacific Time in San Francisco. The presentation is available
via webcast at www.acorda.com.
“AMPYRA has made a significant contribution to the treatment of people
with MS, with more than 73,000 people having tried the drug since its
launch in 2010. Our marketing programs won numerous industry-wide awards
and helped AMPYRA to grow in 2012. We expect continued growth in 2013.
We also initiated proof-of-concept clinical studies of AMPYRA in 2012 in
two additional disease states, post-stroke deficits and cerebral palsy.
We expect to have results for both studies in the second quarter of this
year.”
Dr. Cohen continued, “In December, we acquired rights to Diazepam Nasal
Spray, which adds an important, potential near-term commercial asset to
our pipeline. We are currently preparing a New Drug Application that we
expect to submit to the FDA later this year. In addition, we expect to
have three compounds in Phase 1 or Phase 2 clinical trials in the first
half of 2013 that target significant unmet needs in the areas of heart
failure, multiple sclerosis and spinal cord injury. We are also
continuing to focus on potential in-licensing opportunities, primarily
for approved or near-commercial medicines that can leverage our
exceptional specialty commercial organization and other areas of company
expertise.”
About Acorda
Therapeutics
Acorda Therapeutics is a biotechnology company focused on developing
therapies that restore function and improve the lives of people with MS,
spinal cord injury and other neurological conditions.
Acorda markets AMPYRA®
(dalfampridine) Extended Release Tablets, 10 mg, in the United
States as a treatment to improve walking in patients with multiple
sclerosis (MS). This was demonstrated by an improvement in walking
speed. AMPYRA is marketed outside the United States as FAMPYRA®
(prolonged-release fampridine tablets) by Biogen Idec under a licensing
agreement from Acorda. AMPYRA and FAMPYRA are manufactured under license
from Alkermes Pharma Ireland Limited.
The Company also markets ZANAFLEX
CAPSULES® (tizanidine hydrochloride) and Zanaflex
tablets, a short-acting drug for the management of spasticity. Acorda
also receives sales royalties on tizanidine hydrochloride capsules, an
authorized generic version of ZANAFLEX CAPSULES distributed by Watson
Pharmaceutics, Inc. under its agreement with Acorda.
Acorda has an industry-leading pipeline of novel neurological therapies.
The Company is developing Diazepam Nasal Spray for treatment of certain
epileptic seizures. It is also studying AMPYRA to improve a range of
functional impairments caused by MS, as well as its potential for use in
other neurological conditions, including cerebral palsy and post-stroke
deficits. In addition, Acorda is developing clinical stage compounds
AC105 for acute treatment of spinal cord injury, GGF2 for treatment of
heart failure and rHIgM22, a remyelinating monoclonal antibody, for the
treatment of MS. GGF2 is also being investigated in preclinical studies
as a treatment for neurological conditions such as stroke and spinal
cord injury. Chondroitinase, an enzyme that encourages nerve plasticity
in spinal cord injury, is in preclinical development.
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 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 Diazepam Nasal Spray (“DZNS”) or any
other acquired or in-licensed programs; we may not be able to complete
development of, obtain regulatory approval for, or successfully market
DZNS or other products under development; 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
Idec in connection therewith; competition, including the impact of
generic competition on Zanaflex Capsules revenues; 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; failure to comply with
regulatory requirements could result in adverse action by regulatory
agencies; and the ability to obtain additional financing to support our
operations. These and other risks are described in greater detail
in Acorda Therapeutics' filings with the Securities & 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.