-
AMPYRA® (dalfampridine) Fourth Quarter Net Revenue of $57.2
Million; Full Year 2011 Net Revenue of $210.5 Million
-
Full Year 2012 AMPYRA Net Revenue Guidance of $255-$275 Million
-
Full Year 2012 Guidance for Combined FAMPYRA® ex-U.S.
Royalties and Zanaflex Revenue of at Least $25 Million
-
Company Announces Agreement to Acquire Neuronex, Inc.
HAWTHORNE, N.Y.--(BUSINESS WIRE)--Feb. 16, 2012--
Acorda Therapeutics, Inc. (Nasdaq: ACOR)
today announced its financial results for the fourth quarter and full
year ended December 31, 2011.
“We were pleased with the commercial performance of AMPYRA in 2011, as
well as by the advancement of our product pipeline during the year,”
said Ron Cohen, M.D., Acorda Therapeutics’ President and CEO. “In 2012,
we will focus on disciplined, strategic investment in these areas. We
believe there is ample room to continue to grow AMPYRA within its
current indication, and are supporting marketing initiatives to increase
both consumer awareness and use in people with earlier stages of walking
disability who can benefit from the drug. We also believe that there is
significant potential for AMPYRA to be applied to other indications
within MS and in new disease indications. Therefore, in 2012 our R&D
spend is weighted toward studies assessing additional potential uses of
AMPYRA in MS, as well as in cerebral palsy and chronic stroke.”
“In addition to AMPYRA, we have a robust pipeline of novel therapies
that have either entered clinical development or are planned to do so in
2012. In all of our R&D efforts, we have designed studies to provide
clear ‘go/no go’ signals that will enable us to make efficient decisions
about investing in further development,” added Dr. Cohen. “ We are also
excited about our agreement with Neuronex, Inc. to acquire a pre-NDA
stage therapy in neurology, diazepam nasal spray,”
FINANCIAL RESULTS The Company reported GAAP net income of
$12.7 million for the quarter ended December 31, 2011, or $0.32 per
diluted EPS, including share-based compensation charges totaling $5.5
million. For the full year 2011, the Company reported GAAP net income of
$30.6 million, or $0.76 per diluted EPS, including share-based
compensation charges totaling $19.3 million. The GAAP net income for the
fourth quarter of 2010 was $3.7 million, or $0.09 per diluted EPS
including share-based compensation charges of $5.2 million. For the full
year 2010, GAAP net loss was $11.8 million, or $0.31 per diluted EPS,
including share-based compensation charges of $17.8 million.
Non-GAAP net income, before share-based compensation charges, for the
quarter ended December 31, 2011 was $18.2 million, or $0.45 per diluted
EPS, compared to a non-GAAP net income of $8.9 million, or $0.23 per
diluted EPS for the same quarter in 2010. Full year 2011 non-GAAP net
income was $45.1 million, or $1.13 per diluted EPS, compared to $6.0
million or $0.16 per diluted EPS in 2010.
AMPYRA®
(dalfampridine) Extended Release Tablets, 10 mg net revenue - For
the quarter ended December 31, 2011, the Company reported AMPYRA net
revenue of $57.2 million, compared to $52.3 million in net revenue for
the same quarter in 2010. For the full year 2011, AMPYRA net revenue was
$210.5 million, compared to $133.1 million for full year 2010.
AMPYRA revenue is recognized following shipment of the product from the
Company’s distribution facility to its network of specialty pharmacies.
ZANAFLEX
CAPSULES® (tizanidine
hydrochloride) and ZANAFLEX®
(tizanidine hydrochloride) tablets net revenue - For the quarter
ended December 31, 2011, the Company reported combined net revenue of
ZANAFLEX CAPSULES and ZANAFLEX tablets of $11.8 million, compared to
combined net revenue of $12.1 million for the same quarter in 2010. The
Company reported full year 2011 combined net revenue of $45.8 million,
compared to combined net revenue of $48.5 million for full year 2010.
ZANAFLEX revenue is recognized using a deferred revenue recognition
model, meaning ZANAFLEX CAPSULES and ZANAFLEX tablets shipments to
wholesalers are recorded as deferred revenue and only recognized as
revenue when end-user prescriptions of ZANAFLEX CAPSULES and ZANAFLEX
tablets are reported.
ZANAFLEX CAPSULES and ZANAFLEX tablets shipments -
Total ZANAFLEX CAPSULES and ZANAFLEX tablets shipments for the quarter
ended December 31, 2011 were $15.5 million, compared to total shipments
of $15.8 million for the same quarter in 2010.
For the full year ended December 31, 2011, total ZANAFLEX CAPSULES and
ZANAFLEX tablet shipments were $60.7 million, compared to total
shipments of $57.3 million in 2010.
Cost of sales for the quarter ended
December 31, 2011 were $13.4 million, compared to $12.9 million for the
same quarter in 2010. There was an increase in AMPYRA cost of sales due
to an increase in AMPYRA sales offset by a decrease in ZANAFLEX cost of
sales resulting from accounting adjustments related to the Apotex patent
infringement trial court decision in the third quarter of 2011. Cost of
sales for the full year ended December 31, 2011 were $64.2 million,
compared to $35.5 million in 2010. The increase in full year cost of
sales was due to an increase in AMPYRA sales and $14.1 million in
accounting adjustments in the third quarter of 2011 related to the
Apotex patent infringement trial court decision.
Research and development (R&D) expenses
for the quarter ended December 31, 2011 were $10.3 million, including
$1.7 million of share-based compensation, compared to $8.0 million
including $1.6 million of share-based compensation for the same quarter
in 2010. R&D expenses for the full year ended December 31, 2011 were
$42.1 million, including $5.8 million of share-based compensation,
compared to $30.6 million including $5.3 million of share-based
compensation in 2010. R&D expenses for the full year ended December 31,
2011 included costs related to AMPYRA post-marketing studies and life
cycle management programs, and the development of the Company’s pipeline
products, including Phase 1 clinical trial expenses for Glial Growth
Factor 2 (GGF2) and initiation of an AMPYRA proof-of-concept study in
cerebral palsy.
Sales, general and administrative (SG&A) expenses
for the quarter ended December 31, 2011 were $35.7 million, including
$3.8 million of share-based compensation, compared to $41.6 million
including $3.6 million of share-based compensation for the same quarter
in 2010. SG&A expenses for the full year ended December 31, 2011 were
$148.5 million, including $13.5 million of share-based compensation,
compared to $132.7 million including $12.5 million of share-based
compensation in 2010. The increase in expenses was primarily due to
increases in AMPYRA educational and regulatory activities and other
expenses related to the Apotex patent infringement litigation.
For 2011, the Company was cash flow positive and closed the year in a
strong financial position with cash, cash equivalents and short-term
investments of $295.9 million. This represents an increase of $55.9
million over our 2010 ending cash, cash equivalent and short term
investment balance.
AGREEMENT TO ACQUIRE NEURONEX, INC.
-
On February 15, 2012, the Company entered into an agreement to acquire
privately-held Neuronex, Inc. Under the terms of the agreement, Acorda
has made an upfront payment of $2.0 million to Neuronex, and paid
$500,000 of up to $1.2 million in research funding to prepare for the
diazepam nasal spray pre-NDA meeting.
-
Neuronex is preparing a 505(b)(2) type new drug application (NDA) for
a proprietary nasal spray formulation of diazepam for certain epilepsy
patients. The NDA will provide pharmacokinetic data with the nasal
spray and reference older investigations on efficacy and safety for
DIASTAT® AcuDialTM (diazepam rectal gel), a
rectally-administered diazepam formulation.
-
Following the pre-NDA meeting, Acorda can, at its option, complete the
acquisition by paying Neuronex an additional $6.8 million. If the
acquisition is completed, Acorda will assume oversight and financial
responsibility for all future development and regulatory programs for
diazepam nasal spray. The Company expects these expenses will not
exceed $8 million in 2012.
-
There are potential payments to Neuronex and other parties of $1
million for the completion and acceptance of an NDA, and up to $25
million following regulatory approvals in the United States and
Europe. Acorda will also pay Neuronex milestone payments and royalties
based on net sales of the medication, if approved.
GUIDANCE FOR 2012
-
The following guidance does not take into account the potential
expenditures related to the acquisition of Neuronex and diazepam nasal
spray outlined above, other than the upfront payments that have
already been made.
-
The Company expects AMPYRA full year net revenue of $255-$275 million.
-
The Company expects combined ZANAFLEX® franchise and
ex-U.S.FAMPYRA® (prolonged-release fampridine tablets)
royalty revenue of at least $25 million.
-
SG&A expenses for the full year 2012 are expected to be $145-$160
million, excluding share-based compensation charges. SG&A will be
primarily driven by commercial and administrative costs related to
AMPYRA.
-
R&D expenses for the full year 2012 are expected to be $50-$60
million, excluding share-based compensation. R&D expenses in 2012
related to AMPYRA include post-marketing studies, proof-of-concept
studies in cerebral palsy and chronic stroke, and sponsorship of
investigator-initiated studies. Additional expenses include clinical
trials for GGF2, AC105 and rHIgM22, as well as ongoing preclinical
studies.
-
The Company expects to be cash flow positive in 2012.
AMPYRA UPDATE
-
As of December 2011, approximately 70% of all people with MS who were
prescribed AMPYRA received a first refill. Approximately 40% of all
people with MS who were prescribed AMPYRA received a sixth refill.
-
Compliance rates for AMPYRA are approximately 90%, with patients
currently taking an average of 1.8 tablets per day, compared to
the approved dosing of 2 tablets per day.
-
The United States Patent and Trademark Office (USPTO) allowed U.S.
Patent Application No. 11/102,559 entitled "Method of Using Sustained
Release Aminopyridine Compositions” and issued patent application
11/010,828 “Sustained Release Aminopyridine Composition.” The USPTO
determined that based on preliminary patent term restoration, the
former patent will extend into 2026 and that with final patent term
restoration, the latter patent will extend into 2027.
-
In July 2011, the European Medicines Agency’s (EMA) Committee for
Medicinal Products for Human Use (CHMP) granted conditional marketing
approval for FAMPYRA in Europe. FAMPYRA is being developed and
marketed by Biogen Idec (Nasdaq: BIIB) outside the United States under
a licensing agreement from Acorda.
-
In May 2011, FAMPYRA was approved for use in Australia by
the Australian Therapeutic Goods Administration (ATGA). In November
2011, Biogen Idec received approval by the New Zealand Medicines and
Medical Devices Safety Authority (MEDSAFE). Biogen plans to submit
regulatory filings for FAMPYRA in more than 20 countries in 2012.
-
To date, Biogen Idec has launched FAMPYRA in Germany, United Kingdom,
Australia, Denmark, Norway and Iceland. Launch in most of the
remaining EU countries is expected by the end of 2012.
ZANAFLEX CAPSULES
-
On February 6, 2012, the Company announced a partnership with Watson
Pharmaceuticals, Inc. (NYSE: WPI) to introduce tizanidine
hydrochloride capsules, an authorized generic version of ZANAFLEX
CAPSULES. This followed the February 3, 2012 approval by FDA and
subsequent launch by Apotex Inc. of its generic tizanidine capsules.
PIPELINE UPDATE
-
In December 2011, the Company initiated a proof-of-concept clinical
study of AMPYRA in adults with cerebral palsy.
-
Preclinical data showing significant improvement in motor function
following treatment with dalfampridine was presented at the
International Stroke Conference on February 2, 2012. The Company plans
to begin a proof-of-concept clinical study of AMPYRA in chronic stroke
patients in the second half of 2012.
-
Investigator-initiated studies are exploring potential additional
therapeutic applications of AMPYRA. These studies are assessing
AMPYRA’s impact on functional deficits caused by MS or are exploring
the drug’s use in other neurological disorders.
-
The Company expects to begin enrolling participants in a Phase 2
clinical trial of AC105 in patients with acute spinal cord injury in
the second half of 2012.
-
The Phase 1, escalating dose clinical trial of GGF2 in heart failure
patients is ongoing. The Company expects to announce initial study
results in the second half of 2012.
-
The Company plans to submit an IND for rHIgM22 in the first half of
2012. Phase 1 clinical trials are expected to begin by the end of the
year.
CORPORATE UPDATES
-
In January 2012, General Counsel Jane Wasman, J.D. was named Chief,
Strategic Development. In this new role, Ms. Wasman will assume
additional responsibilities for overseeing the development and
execution of the Company’s long-range strategic plans and objectives.
She will continue to serve as the Company’s General Counsel.
-
In October 2011, Enrique J. Carrazana, M.D. joined the Company as
Chief Medical Officer.
-
In July 2011, the Company announced it had in-licensed AC105, a
therapy being studied in acute spinal cord injury, from Medtronic Inc
(NYSE: MDT). A Phase 1 study had been completed by Medtronic at the
time of the agreement.
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 (loss),
adjusted to exclude share-based compensation charges, the net milestone
revenue relating to Biogen Idec’s receipt of conditional approval from
the European Commission for FAMPYRA in Q3 2011, the ZANAFLEX CAPSULES
adjustments due to the Apotex patent infringement trial court decision
in Q3 2011 and the upfront payment associated with in-licensing AC105 in
Q2 2011. Also, Acorda has provided projected amounts of research and
development (R&D) and sales, general, and administrative (SG&A) expenses
excluding share-based compensation charges. These non-GAAP financial
measures are not an alternative for financial measures prepared in
accordance with GAAP. However, we believe 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 and income that do not
arise from the ordinary course of our business. We believe 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.
WEBCAST AND CONFERENCE CALL Ron Cohen, President and Chief
Executive Officer, and David Lawrence, 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 2011 results.
To participate in the conference call, please dial 866-831-6267
(domestic) or 617-213-8857 (international) and reference the access code
14094231. The presentation will be available via a live webcast at:
http://ir.acorda.com/phoenix.zhtml?c=194451&p=irol-eventDetails&EventId=4713844
A replay of the call will be available from 11:30 a.m. ET on February
16, 2012 until midnight on March 16, 2012. To access the replay, please
dial 888-286-8010 (domestic) or 617-801-6888 (international) and
reference the access code 93934782. 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 AMPYRA can cause seizures; the
risk of seizures increases with increasing AMPYRA doses. AMPYRA is
contraindicated in patients with a prior history of seizure. Discontinue
AMPYRA use if seizure occurs.
AMPYRA is contraindicated in patients with moderate or severe renal
impairment (CrCl less-than or equal to 50 mL/min); the risk of seizures
in patients with mild renal impairment (CrCl 51-80 mL/min) is unknown,
but AMPYRA plasma levels in these patients may approach those seen at a
dose of 15 mg twice daily, a dose that may be associated with an
increased risk of seizures; estimated CrCl should be known before
initiating treatment with AMPYRA.
AMPYRA should not be taken with other forms of 4-aminopyridine (4-AP,
fampridine), since the active ingredient is the same. Urinary tract
infections were reported more frequently as adverse reactions in
patients receiving AMPYRA 10 mg twice daily compared to placebo.
The most common adverse events (incidence greater-than or equal to 2%
and at a rate greater than the placebo rate) for AMPYRA in MS patients
were urinary tract infection, insomnia, dizziness, headache, nausea,
asthenia, back pain, balance disorder, multiple sclerosis relapse,
paresthesia, nasopharyngitis, constipation, dyspepsia, and
pharyngolaryngeal pain.
For full U.S. Prescribing Information and Medication Guide for AMPYRA,
please visit: www.AMPYRA.com.
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 at 888-881-1918. For full U.S.
Prescribing Information and Medication Guide, please visit: www.AMPYRA.com.
About Acorda
Therapeutics Acorda Therapeutics is a biotechnology company
focused on developing therapies that restore function and improve the
lives of people with MS, spinal cord injury and other neurological
conditions.
Acorda markets AMPYRA®
(dalfampridine) Extended Release Tablets, 10 mg, in the United
States as a treatment to improve walking in patients with multiple
sclerosis (MS). This was demonstrated by an improvement in walking
speed. AMPYRA is marketed outside the United States as FAMPYRA®
(prolonged-release fampridine tablets) by Biogen Idec under a licensing
agreement from Acorda. AMPYRA and FAMPYRA are manufactured under license
from Alkermes Pharma Ireland Limited.
The Company also markets ZANAFLEX
CAPSULES® (tizanidine hydrochloride) and Zanaflex
tablets, a short-acting drug for the management of spasticity. Acorda
also receives sales royalties on tizanidine hydrochloride tablets, an
authorized generic version of ZANAFLEX CAPSULES distributed by Watson
Pharmaceutics, Inc. under its agreement with Acorda.
Acorda is developing an industry-leading pipeline of novel neurological
therapies. The Company is studying AMPYRA to improve a range of
functional impairments caused by MS, as well as its use in other
neurological conditions, including cerebral palsy and chronic stroke. In
addition, Acorda is developing clinical stage compounds AC105 for acute
treatment of spinal cord injury and GGF2 for treatment of heart
failure. GGF2 is also being investigated in preclinical studies as a
treatment for neurological conditions such as stroke and spinal cord
injury. Additional preclinical programs include rHIgM22, a remyelinating
monoclonal antibody for the treatment of MS, and chondroitinase, an
enzyme that encourages nerve plasticity in spinal cord injury.
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 Acorda Therapeutics'
ability to successfully market and sell Ampyra in the United States;
third party payers (including governmental agencies) may not reimburse
for the use of Ampyra 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 any
acquired or in-licensed programs; 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 United States 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
Acorda Therapeutics’ 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 the ability to obtain additional financing to support
Acorda Therapeutics' operations. These and other risks are described in
greater detail in Acorda Therapeutics' filings with the Securities and
Exchange Commission. Acorda Therapeutics 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 Therapeutics disclaims any intent or obligation
to update any forward-looking statements as a result of developments
occurring after the date of this press release.
Financial Statements
|
|
|
Acorda Therapeutics, Inc. Condensed Consolidated
Balance Sheet Data (in thousands) (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
December 31, 2011
|
|
|
December 31, 2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
Cash, cash equivalents and short-term investments
|
|
$
|
295,907
|
|
|
$
|
240,029
|
|
Trade receivable, net
|
|
|
22,828
|
|
|
|
22,272
|
|
Other current assets
|
|
|
13,825
|
|
|
|
10,449
|
|
Finished goods inventory
|
|
|
28,382
|
|
|
|
38,418
|
|
Property and equipment, net
|
|
|
3,858
|
|
|
|
3,203
|
|
Intangible assets, net
|
|
|
8,769
|
|
|
|
21,336
|
|
Other assets
|
|
|
5,919
|
|
|
|
6,394
|
|
Total assets
|
|
$
|
379,488
|
|
|
$
|
342,101
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity
|
|
|
|
|
|
|
Accounts payable, accrued expenses and other liabilities
|
|
$
|
45,542
|
|
|
$
|
50,730
|
|
Deferred product revenue
|
|
|
30,599
|
|
|
|
31,296
|
|
Current portion of deferred license revenue
|
|
|
9,057
|
|
|
|
9,429
|
|
Current portion of notes payable
|
|
|
1,144
|
|
|
|
1,144
|
|
Current portion of revenue interest liability
|
|
|
1,001
|
|
|
|
1,297
|
|
Long term liabilities
|
|
|
6,266
|
|
|
|
6,538
|
|
Non-current portion of revenue interest liability
|
|
|
2,928
|
|
|
|
3,977
|
|
Non-current portion of deferred license revenue
|
|
|
77,742
|
|
|
|
86,429
|
|
Stockholders' equity
|
|
|
205,209
|
|
|
|
151,261
|
|
Total liabilities and stockholders' equity
|
|
$
|
379,488
|
|
|
$
|
342,101
|
|
|
|
|
|
|
|
|
|
|
|
|
Acorda Therapeutics, Inc. Consolidated Statements
of Operations (in thousands, except per share amounts) (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31,
|
|
Twelve Months Ended December 31,
|
|
|
|
|
|
|
|
2011
|
|
2010
|
|
2011
|
|
|
2010
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
Net revenues
|
|
$
|
69,049
|
|
|
$
|
64,411
|
|
|
$
|
256,271
|
|
|
|
$
|
181,545
|
|
|
Milestone revenue
|
|
|
-
|
|
|
|
-
|
|
|
|
25,000
|
|
|
|
|
-
|
|
|
License revenue
|
|
|
2,264
|
|
|
|
2,357
|
|
|
|
9,057
|
|
|
|
|
9,428
|
|
|
Royalty revenue
|
|
|
1,331
|
|
|
|
32
|
|
|
|
1,909
|
|
|
|
|
32
|
|
|
Total revenues
|
|
|
72,644
|
|
|
|
66,800
|
|
|
|
292,237
|
|
|
|
|
191,005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
Cost of sales
|
|
|
13,434
|
|
|
|
12,944
|
|
|
|
64,183
|
|
|
|
|
35,518
|
|
|
Cost of milestone and license revenue
|
|
|
159
|
|
|
|
165
|
|
|
|
2,384
|
|
|
|
|
660
|
|
|
Research and development
|
|
|
10,304
|
|
|
|
7,972
|
|
|
|
42,108
|
|
|
|
|
30,600
|
|
|
Selling, general and administrative
|
|
|
35,720
|
|
|
|
41,603
|
|
|
|
148,508
|
|
|
|
|
132,657
|
|
|
Total operating expenses
|
|
|
59,617
|
|
|
|
62,684
|
|
|
|
257,183
|
|
|
|
|
199,435
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss)
|
|
$
|
13,027
|
|
|
$
|
4,116
|
|
|
$
|
35,054
|
|
|
|
$
|
(8,430
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Other expense, net
|
|
|
(85
|
)
|
|
|
(445
|
)
|
|
|
(3,036
|
)
|
|
|
|
(3,339
|
)
|
|
Income (loss) before income taxes
|
|
|
12,942
|
|
|
|
3,671
|
|
|
|
32,018
|
|
|
|
|
(11,769
|
)
|
|
Provision for income taxes
|
|
|
(248
|
)
|
|
|
-
|
|
|
|
(1,413
|
)
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$
|
12,694
|
|
|
$
|
3,671
|
|
|
$
|
30,605
|
|
|
|
$
|
(11,769
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per common share - basic
|
|
$
|
0.32
|
|
|
$
|
0.10
|
|
|
$
|
0.78
|
|
|
|
$
|
(0.31
|
)
|
|
Net income (loss) per common share - diluted
|
|
$
|
0.32
|
|
|
$
|
0.09
|
|
|
$
|
0.76
|
|
|
|
$
|
(0.31
|
)
|
|
Weighted average per common share - basic
|
|
|
39,178
|
|
|
|
38,636
|
|
|
|
39,000
|
|
|
|
|
38,355
|
|
|
Weighted average per common share - diluted
|
|
|
40,152
|
|
|
|
38,911
|
|
|
|
40,064
|
|
|
|
|
38,355
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acorda Therapeutics, Inc. Non-GAAP Income (Loss)
and Income (Loss) per Common Share Reconciliation (in
thousands, except per share amounts) (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31,
|
|
Twelve Months Ended December 31,
|
|
|
|
|
|
|
|
2011
|
|
|
2010
|
|
|
2011
|
|
|
2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net income (loss)
|
|
$
|
12,694
|
|
|
$
|
3,671
|
|
|
$
|
30,605
|
|
|
|
$
|
(11,769
|
)
|
|
Pro forma adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration milestone revenue (Note 1)
|
|
|
-
|
|
|
|
-
|
|
|
|
(25,000
|
)
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of milestone revenue (Note 1)
|
|
|
-
|
|
|
|
-
|
|
|
|
1,750
|
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Zanaflex Capsule adjustments (Note 2)
|
|
|
-
|
|
|
|
-
|
|
|
|
15,477
|
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License agreement expense (Note 3)
|
|
|
-
|
|
|
|
-
|
|
|
|
3,000
|
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expenses included in R&D
|
|
|
1,680
|
|
|
|
1,635
|
|
|
|
5,801
|
|
|
|
|
5,247
|
|
|
Share-based compensation expenses included in SG&A
|
|
|
3,777
|
|
|
|
3,584
|
|
|
|
13,502
|
|
|
|
|
12,530
|
|
|
Total share-based compensation expenses
|
|
|
5,457
|
|
|
|
5,219
|
|
|
|
19,303
|
|
|
|
|
17,777
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total pro forma adjustments
|
|
|
5,457
|
|
|
|
5,219
|
|
|
|
14,530
|
|
|
|
|
17,777
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income
|
|
$
|
18,151
|
|
|
$
|
8,890
|
|
|
$
|
45,135
|
|
|
|
$
|
6,008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per common share - basic
|
|
$
|
0.46
|
|
|
$
|
0.23
|
|
|
$
|
1.16
|
|
|
|
$
|
0.16
|
|
|
Net income per common share - diluted
|
|
$
|
0.45
|
|
|
$
|
0.23
|
|
|
$
|
1.13
|
|
|
|
$
|
0.16
|
|
|
Weighted average per common share - basic
|
|
|
39,178
|
|
|
|
38,636
|
|
|
|
39,000
|
|
|
|
|
38,355
|
|
|
Weighted average per common share - diluted
|
|
|
40,152
|
|
|
|
38,911
|
|
|
|
40,064
|
|
|
|
|
38,355
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 1: $25 million milestone revenue relating to Biogen Idec
receipt of conditional approval from the European Commission for
Fampyra in Q3 2011. Based on Acorda’s worldwide license and
supply agreement with Elan, Elan received 7% of this milestone
payment from Acorda during the same period which was recorded
as cost of milestone revenue.
|
|
Note 2: Adjustments relating to Zanaflex Capsules due to Apotex
patent infringement trial court decision in Q3 2011. ($13,038
Intangible asset impairment included in cost of sales, $1,020
commercial inventory reserve included in cost of sales, $1,083 PRF
put/call liability adjustment included in SG&A, $336 sample
inventory reserve included in SG&A).
|
|
Note 3: $3 million upfront expense related to licensed worldwide
development and commercialization rights to a proprietary
magnesium formulation from Medtronic, Inc. (AC105) included
in R&D Q2 2011.
|
|
|

Source: Acorda Therapeutics, Inc.
Acorda Therapeutics Jeff Macdonald, 914-347-4300 ext. 4232 jmacdonald@acorda.com
|