- AMPYRA® (dalfampridine) First Quarter
Net Revenue of $92.4 Million; 27% Increase from 1Q 2014
Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced its
financial results for the first quarter ended March 31, 2015.
“AMPYRA’s 27% increase in sales this quarter over the same
period last year reflects the continued strong growth of the brand,
which is increasingly considered a standard of care to improve
walking in people with MS,” said Ron Cohen, M.D., Acorda
Therapeutics’ President and CEO.
“We also continued to advance our clinical stage pipeline. We
are enrolling participants in Phase 3 trials for CVT-301 in
Parkinson’s disease and for dalfampridine in chronic post-stroke
walking deficits. Earlier this month, we presented data from our
first Phase 1 clinical trial of rHIgM22 for remyelination in MS at
the American Academy of Neurology meeting. In addition to being
well-tolerated, the antibody was detected in the cerebrospinal
fluid, an encouraging and important step indicating that it enters
the central nervous system. During the second quarter, we expect to
initiate a second Phase 1 study of rHIgM22 in MS patients
experiencing an active relapse.”
FINANCIAL RESULTSThe Company reported a GAAP net loss of
$3.1 million for the quarter ended March 31, 2015, or $0.07 per
diluted share. GAAP net income in the same quarter of 2014 was $0.7
million, or $0.02 per diluted share.
Non-GAAP net income for the quarter ended March 31, 2015 was
$6.5 million, or $0.15 per diluted share. Non-GAAP net income in
the same quarter of 2014 was $8.8 million, or $0.21 per diluted
share. Non-GAAP net income excludes share based compensation
charges, non-cash convertible debt, acquisition related expenses
and tax adjustments. A reconciliation of the GAAP financial results
to non-GAAP financial results is included in the attached financial
statements.
AMPYRA® (dalfampridine) Extended
Release Tablets, 10 mg - For the quarter ended March 31,
2015, the Company reported AMPYRA net revenue of $92.4 million
compared to $72.5 million for the same quarter in 2014.
The Company is reiterating 2015 AMPYRA net sales guidance of
$405-$420 million.
ZANAFLEX CAPSULES®(tizanidine hydrochloride),
ZANAFLEX® (tizanidine hydrochloride) tablets and authorized generic
capsules - For the quarter ended March 31, 2015, the Company
reported combined net revenue and royalties from ZANAFLEX and
tizanidine of $2.6 million compared to $3.1 million for the same
quarter in 2014.
FAMPYRA® (prolonged-release
fampridine tablets) - For the quarter ended March 31, 2015,
the Company reported FAMPYRA royalties from sales outside of the
U.S. of $2.3 million compared to $2.4 million for the same quarter
in 2014.
Research and development (R&D)
expenses for the quarter ended March 31, 2015 were $30.6
million, including $1.8 million of share-based compensation,
compared to $14.5 million including $1.1 million of share-based
compensation for the same quarter in 2014.
The Company is reiterating 2015 R&D guidance of $150-$160
million.
Sales, general and administrative
(SG&A) expenses for the quarter ended March 31, 2015
were $48.8 million, including $5.3 million of share-based
compensation, compared to $46.9 million including $4.7 million of
share-based compensation for the same quarter in 2014.
The Company is reiterating 2015 SG&A guidance of $180-$190
million.
Provision for income taxes for the
quarter ended March 31, 2015 was $(2.0) million, including $0.7
million of cash taxes, compared to $2.8 million, including $0.5
million of cash taxes for the same quarter in 2014.
At March 31, 2015 the Company had cash, cash equivalents and
investments of $299.7 million. The Company expects to be cash flow
positive in 2015.
AMPYRA Update
- The U.S. District Court in Delaware,
which is adjudicating Abbreviated New Drug Application (ANDA)
challenges to certain AMPYRA patents, has scheduled a Markman
hearing for March 2016 and set a trial date for September
2016.
- Petitions for Inter Partes Review (IPR)
of two AMPYRA patents have been submitted to the United States
Patent and Trademark Office (USPTO). The Company is responding to
these filings.
- The Company has five Orange Book-listed
patents on AMPYRA, and will vigorously defend its intellectual
property rights.
Pipeline Update
- In March, the Company presented new
analyses of data from the first Phase 1 clinical trial of
cimaglermin alfa, an investigational drug for heart failure, at the
America College of Cardiology (ACC) 64th Annual Scientific Session
and Expo. The poster contained new analyses of ejection fraction
measures, which found that cimaglermin produced a dose-dependent
benefit at multiple time points for up to three months following a
single infusion. Additional information on adverse events,
demographics, and analysis of hemodynamic and echo parameters were
also reported. Data from the second clinical trial of cimaglermin
in people with heart failure is expected in the second half of
2015.
- In April, the Company presented data
from a Phase 1 clinical trial of rHIgM22, a remyelinating antibody
being studied for the treatment of multiple sclerosis (MS). Safety
data showed rHIgM22 was well-tolerated in each of the five tested
doses, supporting additional clinical development. In addition,
testing detected rHIgM22 in cerebrospinal fluid (CSF), indicating
the drug’s access to the central nervous system. These data were
presented at the 67th American Academy of Neurology Annual Meeting.
The Company expects to begin a second Phase 1 trial in relapsing MS
patients in the second quarter of 2015.
WEBCAST AND CONFERENCE CALLRon 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 first quarter 2015 results.
To participate in the conference call, please dial 800-638-4817
(domestic) or 617-614-3943 (international) and reference the access
code 13484356. 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 12:30 p.m. ET on
April 30, 2015 until midnight on May 7, 2015. To access the replay,
please dial 888-286-8010 (domestic) or 617-801-6888 (international)
and reference the access code 42536532. The archived webcast will
be available for 30 days in the Investor Relations section of the
Acorda website at www.acorda.com.
AMPYRA® (dalfampridine) Important Safety
Information
Do not take AMPYRA if you:
- have ever had a seizure,
- 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.
Before taking AMPYRA, tell your doctor if you:
- have kidney problems or any other
medical conditions;
- are taking compounded
4-aminopyridine;
- are pregnant or plan to become
pregnant. It is not known if AMPYRA will harm your unborn
baby;
- 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 both;
- are taking any other medicines.
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:
- severe 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;
- kidney or bladder infections.
The most common adverse events for AMPYRA in MS patients were
urinary tract infection, trouble sleeping, dizziness, headache,
nausea, weakness, back pain, problems with balance, multiple
sclerosis relapse, burning, tingling, or itching of your skin,
irritation in your nose and throat, constipation, indigestion, and
pain in your throat.
Please see Patient Medication Guide at
www.ampyra.com/medication-guide.pdf for additional safety
information.
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.
About AMPYRA (dalfampridine)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. The
mechanism by which dalfampridine exerts its therapeutic effect has
not been fully elucidated. 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. Eastern Time.
For additional information, including U.S. Full Prescribing
Information and Medication Guide, please visit: www.AMPYRA.com.
About Acorda TherapeuticsFounded in 1995, Acorda
Therapeutics is a biotechnology company focused on developing
therapies that restore function and improve the lives of people
with neurological disorders. 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), as demonstrated by an increase in walking
speed. The Company has one of the leading pipelines in the industry
of novel neurological therapies. Acorda is currently developing a
number of clinical and preclinical stage therapies. This pipeline
addresses a range of disorders including post-stroke walking
deficits, Parkinson’s disease, epilepsy, neuropathic pain, heart
failure, MS, and spinal cord injury. For more information, please
visit the Company’s website at: www.acorda.com.
Forward-Looking StatementsThis 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 Idec 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.
Non-GAAP Financial MeasuresThis 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 the
items below. 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,
(iii) changes in the fair value of acquired contingent
consideration which do not correlate to our actual cash payment
obligations in the current period or (vi) 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.
Financial Statements
Acorda Therapeutics, Inc.
Condensed Consolidated Balance Sheet
Data
(in thousands) (unaudited)
March 31,
December 31,
2015 2014
Assets
Cash, cash equivalents, short-term and long-term investments $
299,697 $ 307,618 Trade receivable, net 30,551 32,211 Other current
assets 27,288 24,052 Finished goods inventory 45,831 26,837
Deferred tax asset 20,469 18,420 Property and equipment, net 45,919
46,090 Goodwill 182,952 182,952 Intangible assets, net 432,155
432,822 Other assets 14,120 9,677 Total assets $
1,098,982 $ 1,080,679
Liabilities and stockholders'
equity Accounts payable, accrued expenses and other liabilities
$ 82,094 $ 73,869 Deferred product revenue 29,121 29,420 Current
portion of deferred license revenue 9,057 9,057 Current portion of
revenue interest liability 749 893 Current portion of notes payable
1,144 1,144 Convertible senior notes 289,607 287,699 Contingent
consideration 55,700 52,600 Non-current portion of deferred license
revenue 48,306 50,570 Deferred tax liability 23,885 23,885 Other
long-term liabilities 10,299 11,287 Stockholders' equity
549,020 540,255 Total liabilities and stockholders' equity $
1,098,982 $ 1,080,679
Acorda Therapeutics, Inc.
Consolidated Statements of
Operations
(in thousands, except per share
amounts)
(unaudited) Three Months Ended March
31, 2015 2014 Revenues:
Net product revenues
$
93,500
$
74,463
Royalty revenues 4,087 3,791 License revenue 2,264
2,264 Total revenues 99,851 80,518 Costs and
expenses: Cost of sales 18,446 15,529 Cost of license revenue 159
159 Research and development 30,636 14,522 Selling, general and
administrative 48,769 46,892 Change in fair value of acquired
contingent consideration 3,100 - Total
operating expenses 101,110 77,102 Operating (loss)
income $ (1,259 ) $ 3,416 Other (expense) income, net
(3,864 ) 80 (Loss) income before income taxes (5,123
) 3,496 Benefit from (provision for) income taxes 2,038 (2,793 )
Net (loss) income $ (3,085 ) $ 703 Net
(loss) income per common share - basic $ (0.07 ) $ 0.02 Net (loss)
income per common share - diluted $ (0.07 ) $ 0.02 Weighted average
per common share - basic 42,031 40,934 Weighted average per common
share - diluted 42,031 42,235
Acorda Therapeutics, Inc.
Non-GAAP Income and Income per Common
Share Reconciliation
(in thousands, except per share
amounts)
(unaudited) Three Months Ended March
31, 2015 2014 GAAP net
(loss) income $ (3,085 ) $ 703 Pro forma adjustments: Non-cash
interest expense (1) 2,103 - Non-cash taxes (2) (2,781 )
2,333 Change in fair value of acquired contingent
consideration (3) 3,100 - Share-based compensation expenses
included in R&D 1,822 1,104 Share-based compensation expenses
included in SG&A 5,304 4,653 Total
share-based compensation expenses 7,126 5,757 Total
pro forma adjustments 9,548 8,090 Non-GAAP net income
$ 6,463 $ 8,793 Net income per common share - basic $
0.15 $ 0.21 Net income per common share - diluted $ 0.15 $ 0.21
Weighted average per common share - basic 42,031 40,934 Weighted
average per common share - diluted 43,585 42,235 (1)
Non-cash interest expense related to convertible senior notes. (2)
$0.7 million and $0.5 million paid in cash taxes in the three
months ended 2015 and 2014, respectively. (3) Changes in fair value
of acquired contingent consideration related to Civitas
transaction.
Acorda TherapeuticsJeff Macdonald,
914-326-5232jmacdonald@acorda.com
Acorda Therapeutics (NASDAQ:ACOR)
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