- AMPYRA® (dalfampridine) Fourth Quarter
Net Revenue of $109.9 Million; Full Year Net Revenue of $366.2
Million
- Full Year AMPYRA 2015 Net Revenue
Guidance of $405-$420 Million
- Full Year 2015 Guidance for R&D
Expense of $150-$160 Million
- Full Year 2015 Guidance for SG&A
Expense of $180-$190 Million
Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced its
financial results for the fourth quarter and full year ended
December 31, 2014.
“During 2014, we made major progress across our three core value
drivers: AMPYRA commercial performance, clinical pipeline and
business development. We grew AMPYRA net revenue 21% over 2013;
AMPYRA is now considered a standard of care in MS. Our acquisition
of Civitas Therapeutics added high-potential products and an
innovative technology platform, complementing an already robust
pipeline,” said Ron Cohen, M.D., Acorda Therapeutics’ President and
CEO. “In 2015, our focus is on maximizing AMPYRA sales, advancing
our late-stage clinical trials and continuing to evaluate business
development opportunities.”
FINANCIAL RESULTS
The Company reported GAAP net income of $0.3 million for the
quarter ended December 31, 2014, or $0.01 per diluted share. GAAP
net income in the same quarter of 2013 was $6.2 million, or $0.15
per diluted share. For the full year ended December 31, 2014, the
Company reported GAAP net income of $17.7 million, or $0.42 per
diluted share. GAAP net income for the full year 2013 was $16.4
million, or $0.39 per diluted share.
Non-GAAP net income for the quarter ended December 31, 2014 was
$19.7 million, or $0.46 per diluted share. Non-GAAP net income in
the same quarter of 2013 was $18.9 million, or $0.45 per diluted
share. Non-GAAP net income for the full year ended December 31,
2014 was $73.8 million, or $1.74 per diluted share. Non-GAAP net
income for the full year ended December 31, 2013 was $52.4 million,
or $1.26 per diluted share. Non-GAAP net income excludes share
based compensation charges, non-cash convertible debt interest
expense, acquisition related expenses, an asset impairment, changes
in fair value of acquired contingent consideration and non-cash 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 December 31,
2014, the Company reported AMPYRA net revenue of $109.9 million
compared to $84.6 million for the same quarter in 2013. For the
full year ended December 31, 2014 net revenue was $366.2 million
compared to $302.6 million for full year 2013. Full year 2014 net
revenue increased 21% over 2013.
ZANAFLEX CAPSULES®(tizanidine hydrochloride),
ZANAFLEX® (tizanidine hydrochloride) tablets and authorized generic
capsules - For the quarter ended December 31, 2014, the
Company reported combined net revenue and royalties from ZANAFLEX
and tizanidine of $3.2 million compared to $3.2 million for the
same quarter in 2013. For the full year ended December 31, 2014
combined net revenue and royalties from ZANAFLEX and tizanidine
were $15.3 million compared to $15.1 million for full year
2013.
FAMPYRA® (prolonged-release
fampridine tablets) - For the quarter ended December 31,
2014, the Company reported FAMPYRA royalties from sales outside of
the U.S. of $2.3 million compared to $2.2 million for the same
quarter in 2013. For the full year ended December 31, 2014, the
Company reported FAMPYRA royalties from sales outside of the U.S.
of $10.0 million compared to $9.3 million for the full year
2013.
Research and development (R&D)
expenses for the quarter ended December 31, 2014 were $25.9
million, including $1.9 million of share-based compensation,
compared to $14.3 million including $1.6 million of share-based
compensation for the same quarter in 2013. R&D expenses for the
full year ended December 31, 2014 were $73.5 million, including
$5.9 million of share-based compensation, compared to $53.9 million
including $5.8 million of share-based compensation for the full
year 2013.
Sales, general and administrative
(SG&A) expenses for the quarter ended December 31, 2014
were $56.5 million, including $6.9 million of share-based
compensation, compared to $47.0 million including $5.6 million of
share-based compensation for the same quarter in 2013. SG&A
expenses for the full year ended December 31, 2014 were $201.8
million, including $23.5 million of share-based compensation,
compared to $185.5 million including $19.3 million of share-based
compensation for the full year 2013.
Benefit from (provision for) income
taxes for the quarter ended December 31, 2014 was $3.0
million of a benefit, including $2.5 million of cash taxes,
compared to $6.4 million of a provision, including $0.9 million of
cash taxes for the same quarter in 2013. Provision for income taxes
for the full year ended December 31, 2014 was $10.3 million,
including $4.4 million of cash taxes, compared to $12.4 million,
including $2.6 million of cash taxes for the full year 2013.
At December 31, 2014 the Company had cash, cash equivalents and
investments of $307.6 million.
Guidance for 2015
The following guidance does not include potential expenditures
related to the acquisition of new products or other business
development activities.
- The Company expects AMPYRA 2015 full
year net revenue of $405-$420 million.
- In 2015, the Company expects ZANAFLEX
franchise and ex-U.S. FAMPYRA revenue of approximately $25 million,
which includes sales of branded ZANAFLEX products and royalties
from ex-U.S. FAMPYRA and authorized generic tizanidine
hydrochloride capsules sales.
- R&D expenses for the full year 2015
are expected to be $150-$160 million, excluding share-based
compensation. The increase in R&D expenses in 2015 is primarily
related to Phase 3 studies of dalfampridine and CVT-301. Additional
expenses include continued development of PLUMIAZTM (diazepam)
Nasal Spray, clinical trials for cimaglermin and rHIgM22, as well
as ongoing preclinical studies.
- SG&A expenses for the full year
2015 are expected to be $180-$190 million, excluding share-based
compensation.
AMPYRA Update
- More than 65% of new AMPYRA patients
currently enroll in First Step, which provides two months of AMPYRA
at no cost. The program is in its fourth year, and data show that
First Step participants have higher compliance and persistency
rates over time compared to non-First Step patients.
- More than 100,000 people with multiple
sclerosis in the United States have tried AMPYRA since its launch
in 2010.
- The Company received eight Paragraph IV
Certification Notice Letters advising that companies have submitted
Abbreviated New Drug Applications (ANDA) to the U.S. Food and
Drug Administration (FDA) requesting permission to manufacture
and market a generic version of AMPYRA. Acorda has filed patent
infringement suits against all ANDA filers to date, triggering a
30-month statutory stay period that restricts FDA from
approving an ANDA until July 2017 at the earliest, unless
a district court issues a decision adverse to all of Acorda’s
asserted Orange Book patents prior to that date.
- In February 2015, a hedge fund filed an
inter partes review (IPR) petition with the U.S. Patent and
Trademark Office, challenging one of the five AMPYRA Orange
Book-listed patents. The Company will oppose the request to
institute the IPR, and if it is allowed to proceed, the Company
will oppose the full proceeding. The 30-month statutory stay period
based on patent infringement suits filed by Acorda against ANDA
filers is not impacted by this filing, and remains in effect.
Pipeline Update
- In February 2015, the Company announced
safety and tolerability data from the first Phase 1 clinical trial
of rHIgM22, a remyelinating antibody for treatment of multiple
sclerosis. The trial, which followed participants for up to six
months after receiving a single dose of rHIgM22, found no
dose-limiting toxicities at any of the five dose levels studied.
Based on these data, the Company plans to initiate a second Phase 1
trial of rHIgM22 in 2015.
- In December 2014, the Company initiated
a Phase 3 clinical trial studying the use of dalfampridine
administered twice-daily (BID) to improve walking in people who
have experienced an ischemic stroke.
- The Company initiated a Phase 3
clinical trial studying the use of CVT-301 to treat OFF episodes in
Parkinson’s disease in December 2014.
- The Company announced it is deferring
further development of NP-1998 for neuropathic pain in 2015.
- The Company is continuing to work with
the FDA to define the additional clinical work necessary for the
approval of PLUMIAZ.
Corporate Update
- In October, the Company completed the
acquisition of Civitas Therapeutics, a privately-held biotechnology
company, obtaining global rights to CVT-301, CVT-427 and the
proprietary ARCUS® pulmonary delivery technology, including a
manufacturing facility with commercial-scale capabilities based in
Chelsea, MA.
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 fourth quarter and full
year 2014 results.
To participate in the conference call, please dial 877-280-4956
(domestic) or 857-244-7313 (international) and reference the access
code 67493058. 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
February 12, 2015 until midnight on February 19, 2015. To access
the replay, please dial 888-286-8010 (domestic) or 617-801-6888
(international) and reference the access code 15118889. 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:
- 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 for full 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. 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 full U.S. Prescribing Information and Medication Guide,
please visit: www.AMPYRA.com.
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 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 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 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 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 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) payments associated with acquisitions that are expenses
that do not arise from the ordinary course of our business, (iv)
asset impairment charges that do not arise from the ordinary course
of our business, (v) changes in 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)
December 31, December 31,
2014
2013
Assets Cash, cash equivalents, short-term and long-term
investments $ 307,618 $ 367,227 Trade receivable, net 32,211 30,784
Other current assets 24,052 17,135 Finished goods inventory 26,837
26,172 Deferred tax asset 18,420 127,299 Property and equipment,
net 46,090 16,525 Goodwill 182,952 - Intangible assets, net 432,822
17,459 Other assets 9,677 4,526 Total assets $
1,080,679 $ 607,127
Liabilities and stockholders'
equity Accounts payable, accrued expenses and other liabilities
$ 73,869 $ 53,491 Deferred product revenue 29,420 32,090 Current
portion of deferred license revenue 9,057 9,057 Current portion of
revenue interest liability 893 861 Current portion of notes payable
1,144 1,144 Convertible senior notes 287,699 - Contingent
consideration 52,600 - Non-current portion of deferred license
revenue 50,570 59,628 Deferred tax liability 23,885 - Other
long-term liabilities 11,287 10,503 Stockholders' equity
540,255 440,353 Total liabilities and stockholders' equity $
1,080,679 $ 607,127
Acorda Therapeutics, Inc.
Consolidated Statements of
Operations
(in thousands, except per share
amounts)
(Unaudited)
Three Months Ended
Twelve Months Ended
December 31,
December 31,
2014 2013
2014 2013
Revenues: Net product revenues $ 110,630 $ 86,348 $ 373,292 $
310,317 Royalty revenues 4,978 3,981 19,131 17,056 License revenue
2,264 2,264 9,057
9,057 Total revenues 117,872 92,593 401,480 336,430
Costs and expenses: Cost of sales 24,977 18,377 79,981 66,009 Cost
of license revenue 158 158 634 634 Research and development 25,921
14,302 73,470 53,877 Selling, general and administrative 56,456
47,007 201,813 185,545 Asset Impairment 6,991 - 6,991 - Change in
fair value of acquired contingent consideration 2,200
- 2,200 - Total operating
expenses 116,703 79,844 365,089 306,065
Operating income $ 1,169 $ 12,749 $ 36,391 $ 30,365 Other
expense, net (3,862 ) (119 ) (8,382 )
(1,502 ) Income (loss) before income taxes (2,693 ) 12,630 28,009
28,863 Benefit from (provision for) income taxes 3,024 (6,437 )
(10,337 ) (12,422 ) Net income $ 331
$ 6,193 $ 17,672 $ 16,441 Net
income per common share - basic $ 0.01 $ 0.15 $ 0.43 $ 0.41 Net
income per common share - diluted $ 0.01 $ 0.15 $ 0.42 $ 0.39
Weighted average per common share - basic 41,532 40,713 41,150
40,208 Weighted average per common share - diluted 43,135 42,102
42,544 41,682
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
December 31, December 31, 2014
2013 2014 2013
GAAP net income $ 331 $ 6,193 $ 17,672 $ 16,441 Pro forma
adjustments: Non-cash interest expense (1) 2,065 - 4,291 -
Non-cash taxes (2) (5,551 ) 5,549 5,981 9,792 Acquisition
related expenses in SG&A (3) 4,893 - 7,248 - Asset
Impairment (4) 6,991 - 6,991 - Change in fair value of
acquired contingent consideration (5) 2,200 - 2,200 -
Product related payments included in R&D (6) - - - 1,000
Share-based compensation expenses included in R&D 1,851 1,559
5,939 5,804 Share-based compensation expenses included in SG&A
6,943 5,577 23,498 19,334 Total
share-based compensation expenses 8,794 7,136 29,437 25,138
Total pro forma adjustments 19,392 12,685
56,148 35,930 Non-GAAP net income $
19,723 $ 18,878 $ 73,820 $ 52,371 Net income per
common share - basic $ 0.47 $ 0.46 $ 1.79 $ 1.30 Net income per
common share - diluted $ 0.46 $ 0.45 $ 1.74 $ 1.26 Weighted average
per common share - basic 41,532 40,713 41,150 40,208 Weighted
average per common share - diluted 43,135 42,102 42,544 41,682
(1) Non-cash interest expense related to convertible senior
notes.
(2) $2.5 million and $0.9 million paid in cash taxes in the
three months ended 2014 and 2013, respectively, and $4.4 million
and $2.6 million paid in cash taxes in the twelve months ended 2014
and 2013, respectively. 2013 revised to include non-cash tax
adjustments to conform with current year presentation.
(3) Deal related expenses for Civitas acquisition.
(4) Non-cash charge for NP-1998 impairment due to
reprioritization of R&D activities in Q4 2014.
(5) Changes in fair value of acquired contingent consideration
related to Civitas transaction.
(6) $1.0M milestone upon the FDA’s acceptance for review of the
first NDA for Plumiaz pursuant to the SK license.
Acorda TherapeuticsJeff Macdonald,
914-326-5232jmacdonald@acorda.com
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