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INBRIJA™ (levodopa inhalation powder) approved December 21, 2018 –
first and only FDA-approved inhaled levodopa for intermittent
treatment of OFF episodes in people with Parkinson’s taking
carbidopa/levodopa
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INBRIJA expected to be available in Q1 2019
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AMPYRA® (dalfampridine) full year 2018 net revenue greater than $430
million (unaudited)
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2018 year-end cash and cash equivalents approximately $445
million (unaudited)
ARDSLEY, N.Y.--(BUSINESS WIRE)--
Acorda Therapeutics, Inc. (NASDAQ: ACOR) today provided 2018 highlights,
2019 guidance and commercialization plans for INBRIJA at the 37th
Annual J.P. Morgan Healthcare Conference in San Francisco.
“The approval of INBRIJA is a major milestone for Acorda. We are eager
to bring this much-needed therapy to the Parkinson’s community,” said
Ron Cohen, M.D., Acorda’s President and CEO. “Acorda has one of the
pre-eminent specialty neurology sales forces in the industry. Our team
will immediately begin visiting key movement disorder centers to begin
demonstrations and training on the appropriate use of INBRIJA. We expect
INBRIJA to be available in the first quarter of 2019.”
Burkhard Blank, M.D., Acorda’s Chief Medical Officer, added, “INBRIJA
represents the first FDA approval of a treatment using the ARCUS®
technology, a platform that allows delivery of relatively large doses of
medication through inhalation. ARCUS has the potential to be used in the
development of a variety of inhaled medicines. In 2019, we will continue
our development of an ARCUS-based treatment for migraine.”
2018 Financials
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AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg unaudited net
sales for 2018 are expected to be greater than $430 million, subject
to change based on discounts and allowances recorded in the fourth
quarter of 2018.
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The Company is reiterating its 2018 non-GAAP operating expense
guidance of R&D $100-$110 million and SG&A $170-$180 million. This
guidance is a non-GAAP projection that excludes share-based
compensation as more fully described below under “Non-GAAP Financial
Measures.”
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2018 year-end cash and cash equivalents were approximately $445
million (unaudited).
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Final results are subject to completion of the Company’s year-end
audit.
2019 Guidance
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During INBRIJA’s 2019 launch year, the Company expects to assess key
metrics such as total and new prescriptions, unique prescribers, and
managed care access, and does not expect to provide INBRIJA revenue
projections.
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The Company will no longer provide revenue guidance for AMPYRA, due to
the unpredictable trajectory of revenue decline given the entrance of
generics.
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R&D expenses for the full year 2019 are expected to be $70-$80 million
and SG&A expenses for the full year 2019 are expected to be $200-$210
million. This guidance is a non-GAAP projection that excludes
share-based compensation as more fully described below under “Non-GAAP
Financial Measures.”
Presentation/Webcast Details
Dr. Cohen will provide a corporate overview at the 37th Annual J.P.
Morgan Healthcare Conference on Wednesday, January 9 at 8:00 a.m.
Pacific/11:00 a.m. Eastern. The presentation is available via webcast at https://jpmorgan.metameetings.net/events/healthcare19/sessions/23912-acorda-therapeutics-inc/webcast
or at www.acorda.com.
Non-GAAP Financial Measures
This press release includes financial measures that were not prepared in
accordance with accounting principles generally accepted in the United
States (GAAP). In particular, Acorda has provided 2018 and 2019 expense
guidance for R&D and SG&A on a non-GAAP basis. Reconciliations of these
measures to the most directly comparable GAAP financial measures are not
available at this time because our analysis of 2018 financial
performance (including share-based compensation expense) is ongoing, and
because the 2019 financial measures are forward looking in nature and
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.
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 actual GAAP results, provides investors with a more
meaningful understanding of our ongoing and projected operating
performance because they exclude non-cash charges that are substantially
dependent on changes in the market price of our common stock. The
Company believes these non-GAAP financial measures help indicate
underlying trends in the Company's business and are important in
comparing current results with prior period results and understanding
expected operating performance. Also, management uses these non-GAAP
financial measures to establish budgets and operational goals, and to
manage the Company's business and to evaluate its performance.
About Acorda Therapeutics
Acorda Therapeutics develops therapies to restore function and improve
the lives of people with neurological disorders. INBRIJA™ (levodopa
inhalation powder) is approved for intermittent treatment of OFF
episodes in patients with Parkinson’s disease treated with
carbidopa/levodopa. INBRIJA is not to be used by patients who take or
have taken a nonselective monoamine oxidase inhibitor such as phenelzine
or tranylcypromine within the last two weeks. INBRIJA utilizes Acorda’s
innovative ARCUS® pulmonary delivery system, a technology platform
designed to deliver medication through inhalation. Acorda also markets
the branded 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: we may
not be able to successfully market Inbrija or any other products under
development; risks associated with complex, regulated manufacturing
processes for pharmaceuticals, which could affect whether we have
sufficient commercial supply of Inbrija to meet market demand; third
party payers (including governmental agencies) may not reimburse for the
use of Inbrija or our other products at acceptable rates or at all and
may impose restrictive prior authorization requirements that limit or
block prescriptions; competition for Inbrija, Ampyra and other products
we may develop and market in the future, including increasing
competition and accompanying loss of revenues in the U.S. from generic
versions of Ampyra (dalfampridine) following our loss of patent
exclusivity; the ability to realize the benefits anticipated from
acquisitions, 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; we may need to raise additional
funds to finance our operations and may not be able to do so on
acceptable terms; the risk of unfavorable results from future studies of
Inbrija (levodopa inhalation powder) or from our other research and
development programs, or any other acquired or in-licensed programs ;
the occurrence of adverse safety events with our products; the outcome
(by judgment or settlement) and costs of legal, administrative or
regulatory proceedings, investigations or inspections, including,
without limitation, collective, representative or class action
litigation; 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:
https://www.businesswire.com/news/home/20190107005388/en/
Felicia Vonella
Acorda Therapeutics
(914) 326-5146
fvonella@acorda.com
Source: Acorda Therapeutics, Inc.