Acorda Therapeutics Reports Fourth Quarter and Full Year 2013 Financial Results
February 13, 2014
AMPYRA® (dalfampridine) Fourth Quarter Net Revenue of $84.6
Million; Full Year 2013 Net Revenue of $302.6 Million
Year-End Cash, Cash Equivalents and Short-Term Investments of $367.2
Full Year 2014 Guidance for AMPYRA Net Revenue of $328-$335 Million
Full Year 2014 Guidance for R&D Expense of $60-$70 Million, Excluding
Full Year 2014 Guidance for SG&A Expense of $180-$190 Million,
Excluding Share-Based Compensation
ARDSLEY, N.Y.--(BUSINESS WIRE)--
Acorda Therapeutics, Inc. (Nasdaq:ACOR)
today announced its financial results for the fourth quarter and full
year ended December 31, 2013.
“We finished 2013 in a strong financial position with growing revenues
and close to $370 million in cash. This puts the Company in an enviable
position to deliver value to shareholders by advancing our pipeline and
acquiring additional assets,” said Ron Cohen, M.D., Acorda Therapeutics’
President and CEO.
“We now have six clinical stage programs in our pipeline. Acorda is
preparing for the potential approval and launch this year of PLUMIAZTM,
the proposed brand name for Diazepam Nasal Spray. We believe PLUMIAZ
addresses a critical need for people with cluster seizures. In addition,
we plan to begin a Phase 3 clinical trial of a new, once-daily
formulation of dalfampridine in post-stroke walking deficits, and move
forward with development of NP-1998, a Phase 3-ready therapy that
represents a potential paradigm shift in the treatment of neuropathic
The Company reported GAAP net income of $6.2 million for the quarter
ended December 31, 2013, or $0.15 per diluted share, including
share-based compensation charges totaling $7.1 million. For the full
year 2013, the Company reported GAAP net income of $16.4 million, or
$0.39 per diluted share, including share-based compensation charges
totaling $25.1 million. GAAP net income in the same quarter of 2012 was
$133.0 million, or $3.27 per diluted share, including share-based
compensation charges totaling $6.1 million and a $132.7 million
non-recurring tax benefit. GAAP net income for the full year 2012 was
$155.0 million, or $3.84 per diluted share, including share-based
compensation charges totaling $21.4 million and a $132.7 million
non-recurring tax benefit.
Non-GAAP net income for the quarter ended December 31, 2013 was $13.3
million, or $0.32 per diluted share and $42.6 million, or $1.02 per
diluted share for the full year 2013. Non-GAAP net income in the same
quarter of 2012 was $9.8 million, or $0.24 per diluted share and $50.3
million, or $1.25 per diluted share for the full year 2012.
(dalfampridine) Extended Release Tablets, 10 mg net revenue - For
the quarter ended December 31, 2013, the Company reported AMPYRA net
revenue of $84.6 million, compared to $72.7 million in net revenue for
the same quarter in 2012. For the year ended December 31, 2013, the
Company reported AMPYRA net revenue of $302.6 million, compared to
$266.1 million in net revenue in 2012.
(tizanidine hydrochloride) tablets and authorized generic capsules net
revenue and royalties - For the quarter ended December 31, 2013,
the Company reported that combined net revenue from ZANAFLEX CAPSULES
and ZANAFLEX tablets sales was $0.8 million, revenue from the sale of
authorized generic tizanidine hydrochloride capsules to Actavis, Inc.
was $0.6 million and royalties from Actavis for the sale of authorized
generic tizanidine hydrochloride capsules were $1.8 million, for
combined total net revenue of $3.2 million. Combined net revenue from
ZANAFLEX CAPSULES and ZANAFLEX tablets sales and royalties from Actavis
were $5.2 million for the same quarter in 2012.
For the full year 2013, the Company reported that combined net revenue
from ZANAFLEX CAPSULES and ZANAFLEX tablets sales was $4.1 million,
revenue from the sale of authorized generic tizanidine hydrochloride
capsules to Actavis, Inc. was $3.2 million and royalties from Actavis
for the sale of authorized generic tizanidine hydrochloride capsules
were $7.8 million, for combined total net revenue of $15.1 million.
Combined net revenue from ZANAFLEX CAPSULES and ZANAFLEX tablets sales
and royalties from Actavis were $23.5 million for the full year 2012.
(prolonged-release fampridine tablets) royalties - For the
quarter ended December 31, 2013, the Company reported FAMPYRA royalties
from sales outside of the U.S. of $2.2 million, compared to $1.3 million
for the same quarter in 2012. For the full year 2013, the Company
reported FAMPYRA royalties from sales outside of the U.S. of $9.3
million, compared to $7.1 million in 2012.
Cost of sales for the quarter ended
December 31, 2013 were $18.4 million, compared to $16.2 million for the
same quarter in 2012. Included in cost of sales for the quarter ended
December 31, 2013 was $0.6 million in cost of authorized generic
tizanidine hydrochloride capsules sold to Actavis. Cost of sales for the
full year 2013 were $66.0 million, compared to $57.0 million for the
full year 2012.
Research and development (R&D) expenses
for the quarter ended December 31, 2013 were $14.3 million, including
$1.6 million of share-based compensation, compared to $18.2 million
including $1.4 million of share-based compensation for the same quarter
in 2012. R&D expenses for the full year 2013 were $53.9 million,
including $5.8 million of share-based compensation, compared to $53.9
million including $5.1 million of share-based compensation for the full
year 2012. R&D expenses for the full year 2013 included the development
of the Company’s pipeline products, including expenses for
dalfampridine-QD, Glial Growth Factor 2 (GGF2), rHIgM22, AC105 and
PLUMIAZ (Diazepam Nasal Spray).
Sales, general and administrative (SG&A) expenses
for the quarter ended December 31, 2013 were $47.0 million, including
$5.6 million of share-based compensation, compared to $45.6 million
including $4.6 million of share-based compensation for the same quarter
in 2012. SG&A expenses for the full year 2013 were $185.5 million,
including $19.3 million of share-based compensation, compared to $168.7
million including $16.3 million of share-based compensation for the full
year 2012. The increase was primarily due to increases in expenses
related to support for AMPYRA and the dalfampridine franchise,
preparations for the possible commercialization of PLUMIAZ (Diazepam
Nasal Spray), and the development of our pipeline products.
At December 31, 2013 the Company had cash, cash equivalents and
short-term and long-term investments of $367.2 million.
GUIDANCE FOR 2014
The following guidance does not include potential expenditures related
to the acquisition of new products or other business development
The Company expects AMPYRA 2014 full year net revenue of $328-$335
In 2014, the Company expects ZANAFLEX franchise and ex-U.S. FAMPYRA
revenue of approximately $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
R&D expenses for the full year 2014 are expected to be $60-$70
million, excluding share-based compensation. R&D expenses in 2014
related to dalfampridine include a Phase 3 study in post-stroke
deficits and sponsorship of investigator-initiated studies. Additional
expenses include continued development of PLUMIAZ (Diazepam Nasal
Spray) and NP-1998, clinical trials for GGF2, rHIgM22 and AC105, as
well as ongoing preclinical studies.
SG&A expenses for the full year 2014 are expected to be $180-$190
million, excluding share-based compensation. SG&A will be primarily
driven by commercial and administrative costs related to AMPYRA and
PLUMIAZ (Diazepam Nasal Spray).
Between launch in March 2010 and the end of 2013, approximately 90,000
people with multiple sclerosis (MS) in the U.S. have tried AMPYRA.
In 2013, two new U.S. AMPYRA patents issued and Acorda now has four
Orange Book patents providing protection up to 2027.
The Company successfully defended a European patent for FAMPYRA
against an opposition.
A New Drug Application (NDA) was filed for Diazepam Nasal Spray in
2013 with the U.S. Food and Drug Administration (FDA), with potential
approval and launch in 2014. The proposed trade name for this product
In April 2013, the Company announced positive Phase 2 data for
dalfampridine extended release tablets in treating post-stroke
deficits. Data showed improved walking in people with post-stroke
deficits. The Company met with the FDA in December 2013 and will
proceed with a Phase 3 study of a once-daily (QD) formulation of
dalfampridine extended release capsules pending FDA agreement on final
study protocol. The study is expected to begin in the second quarter
Post-hoc analyses of the dalfampridine Phase 2 proof-of-concept study
in post-stroke deficits will be included in a platform presentation at
the 2014 International Stroke Conference. The presentation,
“Dalfampridine in Patients with Chronic Post Ischemic Stroke Deficits:
Results from a Phase 2 Study” will be held on February 13, 2014.
Findings from this trial were previously presented at the American
Neurological Association annual meeting in October 2013.
In April 2013, Acorda initiated a Phase 1b study of rHIgM22, a
remyelinating antibody for the treatment of MS. The study is
evaluating safety and tolerability in people with MS, and also
includes several exploratory efficacy measures.
In September 2013, Acorda initiated a Phase 2 trial evaluating the
safety and tolerability of AC105 in people with traumatic spinal cord
injury. This study also includes several exploratory efficacy measures.
In October 2013, Acorda initiated the second clinical trial of GGF2
for the treatment of heart failure. This Phase 1b single-intravenous
infusion trial will assess tolerability of three dose levels of GGF2,
and also includes several exploratory efficacy measures. Trial
enrollment has been paused pending review of additional preclinical
The Company acquired rights in the United States, Canada, Latin
America and certain other markets for two neuropathic pain management
assets from NeurogesX, Inc., QUTENZA® (capsaicin) 8% patch
In 2013, Acorda was ranked the second best large company to work for
in the State of New York. This recognition is based on an annual
survey conducted by Best Companies Group. This marks the third year in
a row that Acorda was ranked in the top 10.
Michael Rogers joined the Company as Chief Financial Officer (CFO). He
is responsible for the Finance and Investor Relations departments.
David Lawrence, M.B.A., who previously served as CFO, was appointed
Chief of Business Operations (CBO). He is responsible for Technical
Operations/Manufacturing, Project Management, Information Technology
and Facilities Management.
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, the payments associated
with product acquisitions and the tax benefit relating to the reduction
of the deferred tax asset valuation allowance in 2012. 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 non-cash charges that are substantially
dependent on changes in the market price of our common stock and
expenses that do not arise from the ordinary course of our business. 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
WEBCAST AND CONFERENCE CALL
Ron Cohen, President and Chief Executive Officer, and Mike Rogers, Chief
Financial Officer,will host a conference call today at 8:30 a.m.
ET to review the Company’s fourth quarter and full year 2013 results.
To participate in the conference call, please dial 800-299-9086
(domestic) or 617-786-2903 (international) and reference the access code
31157384. The presentation will be available via a live webcast on the
Investor section of www.acorda.com.
A replay of the call will be available from 10:30 a.m. ET on February
13, 2014 until midnight on March 13, 2014. To access the replay, please
dial 888-286-8010 (domestic) or 617-801-6888 (international) and
reference the access code 72100535. The archived webcast will be
available for 30 days in the Investor Relations section of the Acorda
website at www.acorda.com.
AMPYRA Important Safety Information
Do not take AMPYRA if you have ever had a seizure, or have certain types
of kidney problems, or are allergic to dalfampridine (4-aminopyridine),
the active ingredient in AMPYRA.
Take AMPYRA exactly as prescribed by your doctor.
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
Your doctor may do a blood test to check how well your kidneys are
working, if that is not known before you start taking AMPYRA.
AMPYRA may cause serious allergic reactions. Stop taking AMPYRA and call
your doctor right away or get emergency medical help if you have
shortness of breath or trouble breathing, swelling of your throat or
tongue, or hives.
AMPYRA should not be taken with other forms of 4-aminopyridine (4-AP,
fampridine), since the active ingredient is the same.
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.
Before taking AMPYRA tell your doctor if you are pregnant or plan to
become pregnant. It is not known if AMPYRA will harm your unborn baby.
Tell your doctor if you are breast-feeding or plan to breast-feed. It is
not known if AMPYRA passes into your breast milk. You and your doctor
should decide if you will take AMPYRA or breast-feed. You should not do
You are encouraged to report negative side effects of prescription drugs
to the FDA. Visit www.fda.gov/medwatch,
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 restore function and improve the lives of
people with neurological conditions. 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 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
Diazepam Nasal Spray 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.
Acorda Therapeutics, Inc. Condensed Consolidated
Balance Sheet Data (in thousands) (Unaudited)
Cash, cash equivalents, short-term and long-term investments
Trade receivable, net
Other current assets
Finished goods inventory
Property and equipment, net
Deferred tax asset
Intangible assets, net
Liabilities and stockholders' equity
Accounts payable, accrued expenses and other liabilities
Deferred product revenue
Current portion of deferred license revenue
Current portion of notes payable
Current portion of revenue interest liability
Non-current portion of revenue interest liability
Non-current portion of deferred license revenue
Total liabilities and stockholders' equity
Acorda Therapeutics, Inc. Consolidated Statements
of Operations (in thousands, except per share amounts) (Unaudited)
Three Months Ended
Twelve Months Ended
Net product revenues
Costs and expenses:
Cost of sales
Cost of license revenue
Research and development
Selling, general and administrative
Total operating expenses
Other expense, net
Income before income taxes
(Provision) benefit for income taxes
Net income per common share - basic
Net income per common share - diluted
Weighted average per common share - basic
Weighted average per common share - diluted
Acorda Therapeutics, Inc. Non-GAAP Income and
Income per Common Share Reconciliation (in thousands,
except per share amounts) (Unaudited)
Three Months Ended
Twelve Months Ended
GAAP net income
Pro forma adjustments:
Product related payments included in R&D
Tax benefit adjustment
Share-based compensation expenses included in R&D
Share-based compensation expenses included in SG&A