Acorda Therapeutics, Inc. (Nasdaq:ACOR)
today announced its financial results for the second quarter ended June
"AMPYRA sales in the second quarter were strong and we are reiterating
our net sales guidance for the year," said Ron Cohen, M.D., Acorda
Therapeutics' President and CEO. "With six clinical-stage compounds
currently in our pipeline, we are creating a diversified portfolio that
addresses significant unmet medical needs and drives shareholder value.
Our balance sheet puts us in a more competitive position to add new
assets to our pipeline, and we are focusing on opportunities that have
the potential to be accretive in the near and intermediate term."
The Company reported GAAP net income of $4.7 million for the quarter
ended June 30, 2014, or $0.11 per diluted share. GAAP net income in the
same quarter of 2013 was $3.9 million, or $0.09 per diluted share.
Non-GAAP net income for the quarter ended June 30, 2014 was $17.7
million, or $0.42 per diluted share. Non-GAAP net income in the same
quarter of 2013 was $14.1 million, or $0.34 per diluted share. Non-GAAP
net income excludes share based compensation charges and non-cash
convertible debt and tax adjustments. A reconciliation of the GAAP
financial results to non-GAAP financial results is included in the
attached financial statements.
(dalfampridine) Extended Release Tablets, 10 mg - For the quarter
ended June 30, 2014, the Company reported AMPYRA net revenue of $87.4
million compared to $77.8 million for the same quarter in 2013.
(tizanidine hydrochloride) tablets and authorized generic capsules
- For the quarter ended June 30, 2014, the Company reported combined net
revenue and royalties from ZANAFLEX and tizanidine of $4.4 million
compared to $4.8 million for the same quarter in 2013.
(prolonged-release fampridine tablets) - For the quarter ended
June 30, 2014, the Company reported FAMPYRA royalties from sales outside
of the U.S. of $2.8 million compared to $2.2 million for the same
quarter in 2013.
Research and development (R&D) expenses
for the quarter ended June 30, 2014 were $16.4 million, including $1.6
million of share-based compensation, compared to $13.2 million including
$1.5 million of share-based compensation for the same quarter in 2013.
Sales, general and administrative (SG&A) expenses
for the quarter ended June 30, 2014 were $50.6 million, including $6.0
million of share-based compensation, compared to $48.0 million including
$5.0 million of share-based compensation for the same quarter in 2013.
The Company is reiterating its 2014 R&D and SG&A expense guidance of
$60-$70 million and $180-$190 million, respectively. This guidance
excludes share-based compensation.
Provision for income taxes for the quarter
ended June 30, 2014 was $6.0 million, including $0.8 million of cash
taxes, compared to $4.2 million, including $0.6 million of cash taxes
for the same quarter in 2013.
At June 30, 2014 the Company had cash, cash equivalents and short-term
and long-term investments of $727.7 million.
WEBCAST AND CONFERENCE CALL
Ron Cohen, President and Chief Executive Officer, and Michael Rogers,
Chief Financial Officer, will host a conference call today at
8:30 a.m. ET to review the Company's second quarter 2014 results.
To participate in the conference call, please dial 877-546-5020
(domestic) or 857-244-7552 (international) and reference the access code
41331388. The presentation will be available via a live webcast on the
Investors section of www.acorda.com.
A replay of the call will be available from 1:30 p.m. ET on July 31,
2014 until midnight on August 7, 2014. To access the replay, please dial
888-286-8010 (domestic) or 617-801-6888 (international) and reference
the access code 97847634. The archived webcast will be available for 30
days in the Investor Relations section of the Acorda website at www.acorda.com.
Important Safety Information
Do not take AMPYRA if you:
Take AMPYRA exactly as prescribed by your doctor.
Before taking AMPYRA, tell your doctor if you:
Stop taking AMPYRA and call your doctor right away if you have a seizure
while taking AMPYRA. You could have a seizure even if you never had a
seizure before. Your chance of having a seizure is higher if you take
too much AMPYRA or if your kidneys have a mild decrease of function,
which is common after age 50. Your doctor may do a blood test to check
how well your kidneys are working before you start AMPYRA.
AMPYRA should not be taken with other forms of 4-aminopyridine (4-AP,
fampridine), since the active ingredient is the same.
AMPYRA may cause serious side effects, including:
The most common adverse events for AMPYRA in MS patients were urinary
tract infection, trouble sleeping, dizziness, headache, nausea,
weakness, back pain, and problems with balance.
Please see Patient
Medication Guide for full safety information.
You are encouraged to report negative side effects of prescription drugs
to the FDA.
or call 1-800-FDA-1088.
AMPYRA is a potassium channel blocker approved as a treatment to improve
walking in patients with multiple sclerosis (MS). This was demonstrated
by an increase in walking speed. AMPYRA, which was previously referred
to as Fampridine-SR, is an extended release tablet formulation of
dalfampridine (4-aminopyridine, 4-AP), and is known as prolonged-,
modified, or sustained-release fampridine (FAMPYRA®) in some
countries outside the United States (U.S.).
In laboratory studies, dalfampridine extended release tablets has been
found to improve impulse conduction in nerve fibers in which the
insulating layer, called myelin, has been damaged. AMPYRA is being
developed and commercialized in the U.S. by Acorda Therapeutics; FAMPYRA
is being developed and commercialized by Biogen Idec in markets outside
the U.S. based on a licensing agreement with Acorda. AMPYRA and FAMPRYA
are manufactured globally by Alkermes Pharma Ireland Limited, a
subsidiary of Alkermes plc, based on a supply agreement with Acorda.
AMPYRA is available by prescription in the United States. For more
information about AMPYRA, including patient assistance and co-pay
programs, healthcare professionals and people with MS can contact AMPYRA
Patient Support Services at 888-881-1918. AMPYRA Patient Support
Services is available Monday through Friday, from 8:00 a.m. to 8:00 p.m.
For full U.S. Prescribing Information and Medication Guide, please
About Acorda Therapeutics
Founded in 1995, Acorda Therapeutics is a biotechnology company focused
on developing therapies that improve the lives of people with
Acorda markets three FDA-approved therapies including: AMPYRA®
(dalfampridine) Extended Release Tablets, 10 mg, a treatment to improve
walking in patients with multiple sclerosis (MS); ZANAFLEX
CAPSULES® (tizanidine hydrochloride) and Zanaflex
tablets, a short-acting drug for the management of spasticity; and QUTENZA®
(capsaicin) 8% Patch, for the management of neuropathic pain associated
with postherpetic neuralgia. AMPYRA is marketed outside the United
States as FAMPYRA® (prolonged-release fampridine tablets) by
Biogen Idec under a licensing agreement from Acorda.
Acorda has one of the leading pipelines in the industry of novel
neurological therapies. The Company is currently developing six
clinical-stage therapies and one preclinical stage therapy that address
a range of disorders including post-stroke deficits, epilepsy, stroke,
peripheral nerve damage, spinal cord injury, neuropathic pain, and heart
failure. For more information, please visit the Company's website at: www.acorda.com.
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 Plumiaz (our trade name for Diazepam
Nasal Spray), or any other acquired or in-licensed programs; we may not
be able to complete development of, obtain regulatory approval for, or
successfully market Plumiaz 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.
Non-GAAP Financial Measures
This press release includes financial results prepared in accordance
with accounting principles generally accepted in the United States
(GAAP), and also certain historical and forward-looking non-GAAP
financial measures. In particular, Acorda has provided income, adjusted
to exclude share-based compensation charges and certain non-cash debt
and tax charges. These 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 because they exclude (i) non-cash
charges and benefits that are substantially dependent on changes in the
market price of our common stock, (ii) non-cash interest charges related
to the accounting for our outstanding convertible debt which are in
excess of the actual interest expense owing on such convertible debt or
(iii) non-cash tax expenses related to our tax accounting which do not
correlate to our actual tax payment obligations. 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 projected 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. A reconciliation of the historical non-GAAP
financial results presented in this release to our GAAP financial
results is included in the attached financial statements.
Acorda Therapeutics, Inc.
Condensed Consolidated Balance Sheet Data
Consolidated Statements of Operations
(in thousands, except per share amounts)
Non-GAAP Income and Income per Common Share Reconciliation
Share-based compensation expenses included in SG&A
Non-cash interest expense related to convertible senior notes.
$0.8 million and $0.6 million paid in cash taxes in the three
months ended 2014 and 2013, respectively, and $1.2 million and
$1.3 million paid in cash taxes in the six months ended 2014 and
2013, respectively. 2013 revised to include non-cash tax
adjustments to conform with current year presentation.
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