- 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/
Acorda TherapeuticsJeff Macdonald,
914-326-5232jmacdonald@acorda.com
Acorda Therapeutics (NASDAQ:ACOR)
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