-
AMPYRA® (dalfampridine) 2Q 2015 Net Revenue of $105.5
Million; 21% increase over 2Q 2014
-
AMPYRA Net Sales Guidance for 2015 Narrowed to $410-$420 Million
-
2015 R&D Guidance Revised to $140-$150 Million
Acorda Therapeutics, Inc. (Nasdaq:ACOR)
today provided a financial and pipeline update for the second quarter
ended June 30, 2015.
“The growth of AMPYRA over the last several quarters is a result of our
team’s continued strong performance in educating healthcare
professionals and people with MS about the value of this important
medication,” said Ron Cohen, M.D., Acorda Therapeutics’ President and
CEO.
“Our top priority is successful development of our clinical pipeline,
which addresses major unmet medical needs and has the potential to
create substantial shareholder value. This includes near term
opportunities CVT-301 for the treatment of off episodes in Parkinson’s
disease and PLUMIAZ for the treatment of seizure clusters in epilepsy.”
Financial Results
The Company reported GAAP net income of $1.0 million for the quarter
ended June 30, 2015, or $0.02 per diluted share. GAAP net income in the
same quarter of 2014 was $4.7 million, or $0.11 per diluted share.
Non-GAAP net income for the quarter ended June 30, 2015 was $13.5
million, or $0.31 per diluted share. Non-GAAP net income in the same
quarter of 2014 was $17.7 million, or $0.42 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 June 30, 2015, the Company reported AMPYRA net revenue
of $105.5 million compared to $87.4 million for the same quarter in 2014.
The Company narrowed 2015 AMPYRA net sales guidance from $405-$420
million to $410-$420 million.
ZANAFLEX CAPSULES® (tizanidine hydrochloride), ZANAFLEX®
(tizanidine hydrochloride) tablets and authorized generic capsules - For
the quarter ended June 30, 2015, the Company reported combined net
revenue and royalties from ZANAFLEX and tizanidine of $3.2 million
compared to $4.4 million for the same quarter in 2014.
FAMPYRA® (prolonged-release fampridine tablets) - For the
quarter ended June 30, 2015, the Company reported FAMPYRA royalties from
sales outside of the U.S. of $2.5 million compared to $2.8 million for
the same quarter in 2014.
Research and development (R&D) expenses for the quarter ended June 30,
2015 were $31.2 million, including $2.2 million of share-based
compensation, compared to $16.4 million including $1.6 million of
share-based compensation for the same quarter in 2014.
The Company revised 2015 R&D guidance from $150-$160 million to
$140-$150 million. This guidance excludes share-based compensation.
Sales, general and administrative (SG&A) expenses for the quarter ended
June 30, 2015 were $52.8 million, including $6.5 million of share-based
compensation, compared to $50.6 million including $6.0 million of
share-based compensation for the same quarter in 2014.
The Company reiterated 2015 SG&A guidance of $180-$190 million. This
guidance excludes share-based compensation.
Provision for income taxes for the quarter ended June 30, 2015 was $1.1
million, including $0.6 million of cash taxes, compared to $6.0 million,
including $0.8 million of cash taxes for the same quarter in 2014.
At June 30, 2015 the Company had cash, cash equivalents and investments
of $301.7 million. The Company expects to be cash flow positive in 2015.
Quarterly Highlights
-
CVT-301
-
In June, the Company presented data from a Phase 2b clinical trial
of CVT-301 at the 19th International Congress of Parkinson's
Disease and Movement Disorders (MDS) in San Diego, CA. The data
showed that patients experiencing an off episode, treated with
CVT-301, experienced significantly greater improvements in motor
function than patients treated with inhaled placebo.
-
The CVT-301 poster at MDS was one of only 19 selected from almost
1,500 poster presentations for the conference’s Blue Ribbon
Highlights Session. The session provided a critical review of the
best poster presentations, highlighting relevance, novelty and
quality of both clinical data and basic research.
-
PLUMIAZ™ (diazepam) Nasal Spray
-
In May, the Company announced it had completed discussions with
the U.S. Food and Drug Administration (FDA), and is advancing the
development of PLUMIAZ. The Company will conduct three clinical
trials prior to resubmitting the New Drug Application (NDA) for
PLUMIAZ.
-
Cimaglermin alfa
-
In June, the Company announced that it had stopped enrollment in
the Phase 1b clinical trial of cimaglermin alfa based on the
occurrence of a case of hepatotoxicity (liver injury) meeting Hy’s
Law criteria, based on blood test results. The Company also
received a notification of clinical hold from the FDA following
the submission of this information. There was one Hy’s Law case
reported in the previous Phase 1 study. In both cases the abnormal
blood tests resolved within several days. The 23 patients who were
dosed in the trial will complete the pre-planned one year of
follow up. The Company expects to complete an analysis of data
from the three-month follow up by the end of the year. The Company
has ongoing analyses and non-clinical studies to investigate the
biological basis for liver interactions of cimaglermin, and plans
to review these and other data from the cimaglermin studies with
the FDA.
-
AMPYRA (dalfampridine)
-
The Company submitted responses to two Inter Partes Review (IPR)
petitions in May and June to the United States Patent and
Trademark Office (USPTO). The deadlines for the rulings on the
institution of the IPRs are August and September, respectively.
-
The Company has five Orange Book-listed patents on AMPYRA, and
will vigorously defend its intellectual property rights.
-
ARCUS® Technology
-
The Company plans to begin a Phase 1 clinical study of CVT-427 by
the end of the year. CVT-427 is an inhaled triptan in development
for relief of acute migraine using the ARCUS technology.
-
In July, the Company announced it had received a $1.4 million
grant from the Bill & Melinda Gates Foundation to support the
development of a formulation and delivery system for a dry powder
version of synthetic lung surfactant used to treat neonatal
respiratory distress syndrome (RDS). The formulation will utilize
the Company’s proprietary ARCUS technology, and will be produced
in collaboration with the Massachusetts Institute of Technology
(MIT).
-
Corporate
-
President and CEO Ron Cohen, M.D. was named the Biotechnology
Industry Organization (BIO) Chair for the 2015-2016 term. He will
also serve as the Chairman of the Health Section Governing Board.
Webcast and Conference Call
Ron Cohen, President and Chief Executive Officer, and Michael Rogers,
Chief Financial Officer, will host a conference call today at
8:30 a.m. ET to review the Company’s second quarter 2015 results.
To participate in the conference call, please dial 855-542-4209
(domestic) or 412-455-6054 (international) and reference the access code
83307996. The presentation will be available via a live webcast on the
Investors section of www.acorda.com.
A replay of the call will be available from 1:30 p.m. ET on July 30,
2015 until midnight on August 6, 2015. To access the replay, please dial
855-859-2056 (domestic) or 404-537-3406 (international) and reference
the access code 83307996. The archived webcast will be available for 30
days in the Investor Relations section of the Acorda website at www.acorda.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. 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.
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) changes in the fair value of acquired contingent consideration
which do not correlate to our actual cash payment obligations in the
current period or (iv) 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)
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
|
2015
|
|
|
2014
|
Assets
|
|
|
|
|
|
|
|
Cash, cash equivalents, short-term and long-term investments
|
|
|
|
$
|
301,720
|
|
|
$
|
307,618
|
Trade receivable, net
|
|
|
|
|
29,797
|
|
|
|
32,211
|
Other current assets
|
|
|
|
|
27,593
|
|
|
|
24,052
|
Finished goods inventory
|
|
|
|
|
49,202
|
|
|
|
26,837
|
Deferred tax asset
|
|
|
|
|
19,321
|
|
|
|
18,420
|
Property and equipment, net
|
|
|
|
|
44,453
|
|
|
|
46,090
|
Goodwill
|
|
|
|
|
182,952
|
|
|
|
182,952
|
Intangible assets, net
|
|
|
|
|
431,759
|
|
|
|
432,822
|
Other assets
|
|
|
|
|
13,753
|
|
|
|
9,677
|
Total assets
|
|
|
|
$
|
1,100,550
|
|
|
$
|
1,080,679
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity
|
|
|
|
|
|
|
|
Accounts payable, accrued expenses and other liabilities
|
|
|
|
$
|
72,482
|
|
|
$
|
73,869
|
Deferred product revenue
|
|
|
|
|
28,403
|
|
|
|
29,420
|
Current portion of deferred license revenue
|
|
|
|
|
9,057
|
|
|
|
9,057
|
Current portion of revenue interest liability
|
|
|
|
|
585
|
|
|
|
893
|
Current portion of notes payable
|
|
|
|
|
1,144
|
|
|
|
1,144
|
Convertible senior notes
|
|
|
|
|
291,538
|
|
|
|
287,699
|
Contingent consideration
|
|
|
|
|
56,800
|
|
|
|
52,600
|
Non-current portion of deferred license revenue
|
|
|
|
|
46,042
|
|
|
|
50,570
|
Deferred tax liability
|
|
|
|
|
23,885
|
|
|
|
23,885
|
Other long-term liabilities
|
|
|
|
|
10,330
|
|
|
|
11,287
|
Stockholders' equity
|
|
|
|
|
560,284
|
|
|
|
540,255
|
Total liabilities and stockholders' equity
|
|
|
|
$
|
1,100,550
|
|
|
$
|
1,080,679
|
|
|
|
|
|
|
|
|
|
|
|
Acorda Therapeutics, Inc. Consolidated Statements
of Operations (in thousands, except per share amounts) (unaudited)
|
|
|
|
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
|
2015
|
|
|
2014
|
|
|
2015
|
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product revenues
|
|
|
|
$
|
107,565
|
|
|
|
$
|
89,719
|
|
|
|
$
|
201,064
|
|
|
|
$
|
164,182
|
|
Royalty revenues
|
|
|
|
|
3,878
|
|
|
|
|
5,146
|
|
|
|
|
7,966
|
|
|
|
|
8,937
|
|
License revenue
|
|
|
|
|
2,264
|
|
|
|
|
2,264
|
|
|
|
|
4,529
|
|
|
|
|
4,529
|
|
Total revenues
|
|
|
|
|
113,707
|
|
|
|
|
97,129
|
|
|
|
|
213,559
|
|
|
|
|
177,648
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales
|
|
|
|
|
22,708
|
|
|
|
|
18,899
|
|
|
|
|
41,155
|
|
|
|
|
34,428
|
|
Cost of license revenue
|
|
|
|
|
159
|
|
|
|
|
159
|
|
|
|
|
317
|
|
|
|
|
317
|
|
Research and development
|
|
|
|
|
31,229
|
|
|
|
|
16,448
|
|
|
|
|
61,865
|
|
|
|
|
30,970
|
|
Selling, general and administrative
|
|
|
|
|
52,819
|
|
|
|
|
50,644
|
|
|
|
|
101,589
|
|
|
|
|
97,537
|
|
Change in fair value of acquired contingent consideration
|
|
|
|
|
1,100
|
|
|
|
|
-
|
|
|
|
|
4,200
|
|
|
|
|
-
|
|
Total operating expenses
|
|
|
|
|
108,015
|
|
|
|
|
86,150
|
|
|
|
|
209,126
|
|
|
|
|
163,252
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income
|
|
|
|
$
|
5,692
|
|
|
|
$
|
10,979
|
|
|
|
$
|
4,433
|
|
|
|
$
|
14,396
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other expense, net
|
|
|
|
|
(3,565
|
)
|
|
|
|
(261
|
)
|
|
|
|
(7,430
|
)
|
|
|
|
(181
|
)
|
Income (loss) before income taxes
|
|
|
|
|
2,127
|
|
|
|
|
10,718
|
|
|
|
|
(2,997
|
)
|
|
|
|
14,215
|
|
(Provision for) benefit from income taxes
|
|
|
|
|
(1,130
|
)
|
|
|
|
(6,033
|
)
|
|
|
|
909
|
|
|
|
|
(8,825
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
|
|
$
|
997
|
|
|
|
$
|
4,685
|
|
|
|
$
|
(2,088
|
)
|
|
|
$
|
5,390
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per common share - basic
|
|
|
|
$
|
0.02
|
|
|
|
$
|
0.11
|
|
|
|
$
|
(0.05
|
)
|
|
|
$
|
0.13
|
|
Net income (loss) per common share - diluted
|
|
|
|
$
|
0.02
|
|
|
|
$
|
0.11
|
|
|
|
$
|
(0.05
|
)
|
|
|
$
|
0.13
|
|
Weighted average per common share - basic
|
|
|
|
|
42,085
|
|
|
|
|
41,032
|
|
|
|
|
42,058
|
|
|
|
|
40,985
|
|
Weighted average per common share - diluted
|
|
|
|
|
43,282
|
|
|
|
|
42,432
|
|
|
|
|
42,058
|
|
|
|
|
42,336
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acorda Therapeutics, Inc. Non-GAAP Income and
Income per Common Share Reconciliation (in thousands,
except per share amounts) (unaudited)
|
|
|
|
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
|
2015
|
|
|
2014
|
|
|
2015
|
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net (loss) income
|
|
|
|
$
|
997
|
|
|
$
|
4,685
|
|
|
$
|
(2,088
|
)
|
|
|
$
|
5,390
|
Pro forma adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash interest expense (1)
|
|
|
|
|
2,128
|
|
|
|
157
|
|
|
|
4,230
|
|
|
|
|
157
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash taxes (2)
|
|
|
|
|
550
|
|
|
|
5,279
|
|
|
|
(2,232
|
)
|
|
|
|
7,611
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of acquired contingent consideration (3)
|
|
|
|
|
1,100
|
|
|
|
-
|
|
|
|
4,200
|
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expenses included in R&D
|
|
|
|
|
2,159
|
|
|
|
1,562
|
|
|
|
3,982
|
|
|
|
|
2,666
|
Share-based compensation expenses included in SG&A
|
|
|
|
|
6,549
|
|
|
|
6,054
|
|
|
|
11,853
|
|
|
|
|
10,707
|
Total share-based compensation expenses
|
|
|
|
|
8,708
|
|
|
|
7,616
|
|
|
|
15,835
|
|
|
|
|
13,373
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total pro forma adjustments
|
|
|
|
|
12,486
|
|
|
|
13,052
|
|
|
|
22,033
|
|
|
|
|
21,141
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income
|
|
|
|
$
|
13,483
|
|
|
$
|
17,737
|
|
|
$
|
19,945
|
|
|
|
$
|
26,531
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per common share - basic
|
|
|
|
$
|
0.32
|
|
|
$
|
0.43
|
|
|
$
|
0.47
|
|
|
|
$
|
0.65
|
Net income per common share - diluted
|
|
|
|
$
|
0.31
|
|
|
$
|
0.42
|
|
|
$
|
0.46
|
|
|
|
$
|
0.63
|
Weighted average per common share - basic
|
|
|
|
|
42,085
|
|
|
|
41,032
|
|
|
|
42,058
|
|
|
|
|
40,985
|
Weighted average per common share - diluted
|
|
|
|
|
43,282
|
|
|
|
42,432
|
|
|
|
43,434
|
|
|
|
|
42,336
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Non-cash interest expense related to the convertible senior
notes.
|
(2) $0.6 million and $0.8 million paid in cash taxes in the three
months ended 2015 and 2014, respectively; $1.3 million and $1.2
million paid in cash taxes in the six months ended 2015 and 2014,
respectively.
|
(3) Changes in fair value of acquired contingent consideration
related to the Civitas transaction.
|
|
View source version on businesswire.com: http://www.businesswire.com/news/home/20150730005410/en/
Copyright Business Wire 2015