- AMPYRA® (dalfampridine) 4Q 2015 Net
Revenue of $122 Million; 11% increase over 4Q 2014
- AMPYRA Full-Year Net Revenue of $437
Million, 19% increase over 2014
- AMPYRA 2016 Net Sales Guidance of
$475-$485 Million
- Biotie acquisition will expand
Parkinson’s disease franchise; will add three clinical stage
compounds, including promising Phase 3 program
Acorda Therapeutics, Inc. (Nasdaq:ACOR) today provided a
financial and pipeline update for the fourth quarter and full year
ended December 31, 2015.
“Our acquisition of Biotie will position Acorda as a leader in
Parkinson’s disease therapeutics development, with three clinical
stage compounds that have the potential to improve the lives of
people living with this condition,” said Ron Cohen, M.D., Acorda's
President and CEO. “We expect this acquisition to be completed in
the third quarter of 2016, subject to customary closing conditions.
At that time, Acorda will have four programs in Phase 3
development, with three NDA filings expected in 2017 and 2018.”
“AMPYRA’s continued strong performance reflects outstanding
execution by our commercial team. The same team will be responsible
for launching the late stage products in our pipeline, if approved;
we believe that these products - CVT-301 and tozadenant in
Parkinson’s and PLUMIAZ in epilepsy - represent potential U.S. peak
net sales of more than $1 billion.”
Financial Results
The Company reported GAAP net income of $9.2 million for the
quarter ended December 31, 2015, or $0.21 per diluted share. GAAP
net income in the same quarter of 2014 was $0.3 million, or $.01
per diluted share. For the full year ended December 31, 2015,
the Company reported GAAP net income of $11.1 million,
or $0.25 per diluted share. GAAP net income for the full year
2014 was $17.7 million, or $0.42 per diluted
share.
Non-GAAP net income for the quarter ended December 31, 2015 was
$12.5 million, or $0.28 per diluted share. Non-GAAP net income in
the same quarter of 2014 was $19.7 million, or $0.46 per diluted
share. Non-GAAP net income for the full year ended December
31, 2015 was $46.0 million, or $1.05 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 excludes
share-based compensation charges, non-cash interest charges on our
convertible debt, changes in the fair value of acquired contingent
consideration, acquisition related expenses, the impact of a change
in accounting policy for Zanaflex revenue recognition, asset
impairment charges and non-cash tax expenses. A reconciliation of
the GAAP financial results to non-GAAP financial results is
included with the attached financial statements.
AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg - For
the quarter ended December 31, 2015, the Company reported AMPYRA
net revenue of $122.0 million compared to $109.9 million for the
same quarter in 2014. For the full year ended December 31,
2015 net revenue was $436.9 million compared
to $366.2 million for full year 2014. Full year 2015 net
revenue increased 19% over 2014.
ZANAFLEX CAPSULES® (tizanidine hydrochloride), ZANAFLEX®
(tizanidine hydrochloride) tablets and authorized generic capsules
- For the quarter ended December 31, 2015, the Company reported
combined net revenue and royalties from ZANAFLEX and tizanidine of
$3.3 million compared to $3.2 million for the same quarter in 2014.
For the full year ended December 31, 2015 combined net
revenue and royalties from ZANAFLEX and tizanidine were $35.1
million compared to $15.3 million for full year
2014. Net revenue for Zanaflex for the full year ended December 31,
2015 includes the impact of a one-time net adjustment of $22.2
million, representing the cumulative impact of the Company’s
conversion from the sell-through to the sell-in method of revenue
recognition.
FAMPYRA® (prolonged-release fampridine tablets) - For the
quarter ended December 31, 2015, the Company reported FAMPYRA
royalties from sales outside of the U.S. of $3.3 million compared
to $2.3 million for the same quarter in 2014. For the full year
ended December 31, 2015, the Company reported FAMPYRA royalties
from sales outside of the U.S. of $10.5 million compared
to $10.0 million for the full year 2014.
Research and development (R&D) expenses for the quarter
ended December 31, 2015 were $44.0 million, including $2.2 million
of share-based compensation, compared to $25.9 million, including
$1.9 million of share-based compensation, for the same quarter in
2014. R&D expenses for the full year ended December 31,
2015 were $149.2 million, including $8.5 million of
share-based compensation, compared to $73.5
million, including $5.9 million of share-based
compensation, for the full year 2014.
Sales, general and administrative (SG&A) expenses for the
quarter ended December 31, 2015 were $53.0 million, including $6.5
million of share-based compensation, compared to $56.5 million
including $6.9 million of share-based compensation for the same
quarter in 2014. SG&A expenses for the full year
ended December 31, 2015 were $205.6 million,
including $25.0 million of share-based compensation,
compared to $201.8 million including $23.5
million of share-based compensation for the full year
2014.
Benefit from income taxes for the quarter ended December 31,
2015 was $8.6 million, including $2.5 million of cash taxes,
compared to $3.0 million, including $2.5 million of cash taxes for
the same quarter in 2014. Provision for income taxes for the full
year ended December 31, 2015 was $8.3 million,
including $4.7 million of cash taxes, compared
to $10.3 million, including $4.4 million of cash
taxes for the full year 2014.
At December 31, 2015 the Company had cash, cash equivalents and
investments of $353.3 million.
Guidance for 2016
The following guidance does not include potential expenditures
related to the acquisition of Biotie Therapies or other business
development activities.
- The Company expects AMPYRA 2016 full
year net revenue of $475-$485 million.
- R&D expenses for the full year 2016
are expected to be $165-$175 million, excluding share-based
compensation.
- SG&A expenses for the full year
2016 are expected to be $195-$205 million, excluding share-based
compensation.
Quarterly Highlights
- Business Development
- On January 19, the Company announced
that it entered into an agreement to acquire Biotie Therapies
Corp., including worldwide rights to tozadenant, an oral adenosine
A2a receptor antagonist currently in Phase 3 development in
Parkinson’s disease. The transaction, valued at approximately $363
million, is expected to close in the third quarter of 2016.
- AMPYRA (dalfampridine)
- In December 2015 and January 2016,
respectively, the Company announced it had entered into two
settlement agreements, with Aurobindo Pharma Ltd. and Par
Pharmaceutical, Inc., to resolve pending patent litigation related
to AMPYRA. As a result of the settlement agreements, both Aurobindo
and Par will be permitted to market a generic version of AMPYRA in
the United States at a specified date in 2027, or potentially
earlier under certain circumstances.
- CVT-427
- In December, the Company initiated and
completed a Phase 1 study of CVT-427 for the treatment of acute
migraine. The Company will provide an update by end of the first
quarter 2016.
- Corporate
- In December, the Company presented
analyses from a study showing the effect of rescue medication for
seizure clusters on both clinical outcomes and healthcare resource
utilization. The analyses were presented at the 69th Annual Meeting
of the American Epilepsy Society in Philadelphia, PA.
- In January 2016, Chief Medical Officer
(CMO) Enrique Carrazana, M.D. left the Company. Burkhard
Blank, M.D., has assumed the position of interim CMO.
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 2015 results.
To participate in the conference call, please dial (855)
542-4209 (domestic) or (412) 455-6054 (international) and reference
the access code 37655218. 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
February 11, 2016 until 11:59 pm on February 18, 2016. To access
the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406
(international) and reference the access code 37655218. The
archived webcast will be available in the Investor Relations
section of the Acorda website at www.acorda.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 has an industry leading pipeline of novel neurological
therapies addressing a range of disorders, including multiple
sclerosis, Parkinson’s disease, post-stroke walking deficits,
epilepsy and migraine. Acorda markets three FDA-approved
therapies, including AMPYRA® (dalfampridine) Extended Release
Tablets, 10 mg.
Forward-Looking Statement
This press release includes forward-looking statements. 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 complete the Biotie
transaction on a timely basis or at all; the ability to realize the
benefits anticipated from the Biotie and Civitas transactions,
among other reasons because acquired development programs are
generally subject to all the risks inherent in the drug development
process and our knowledge of the risks specifically relevant to
acquired programs generally improves over time; the ability to
successfully integrate Biotie’s operations and Civitas’ operations,
respectively, into our operations; we may need to raise additional
funds to finance our expanded operations and may not be able to do
so on acceptable terms; 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, any other
products under development, or the products that we would acquire
if we complete the Biotie transaction; the occurrence of adverse
safety events with our products; delays in obtaining or failure to
obtain and maintain regulatory approval of or to successfully
market Fampyra outside of the U.S. and our dependence on our
collaboration partner Biogen 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 our
filings with the Securities and Exchange Commission. We may
not actually achieve the goals or plans described in our
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 we disclaim
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, (iv) non-cash tax expenses
related to our tax accounting which do not correlate to our actual
tax payment obligations, (v) the impact of a change in accounting
policy with regards to revenue recognition for our Zanaflex product
line due to a one-time, non-recurring event, (vi) asset impairment
charges that do not arise from the ordinary course of our business
and (vii) acquisition related expenses that pertain to a
non-recurring event. 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,
2015
2014
Assets Cash, cash equivalents, short-term and
long-term investments $ 353,305 $ 307,618 Trade receivable, net
31,466 32,211 Other current assets 30,070 24,052 Finished goods
inventory 36,476 26,837 Deferred tax asset 2,128 2,806 Property and
equipment, net 40,204 46,090 Goodwill 183,636 182,952 Intangible
assets, net 430,856 432,822 Other assets 8,202 9,677
Total assets $ 1,116,343 $ 1,065,065
Liabilities and
stockholders' equity Accounts payable, accrued expenses and
other liabilities $ 80,366 $ 73,869 Deferred product revenue -
29,420 Current portion of deferred license revenue 9,057 9,057
Current portion of revenue interest liability 25 893 Current
portion of notes payable 1,144 1,144 Convertible senior notes
295,469 287,699 Contingent consideration 63,500 52,600 Non-current
portion of deferred license revenue 41,513 50,570 Deferred tax
liability 12,146 8,271 Other long-term liabilities 10,098 11,287
Stockholders' equity 603,025 540,255 Total
liabilities and stockholders' equity $ 1,116,343 $ 1,065,065
Acorda Therapeutics, Inc.
Consolidated Statements of
Operations
(in thousands, except per share
amounts)
(unaudited)
Three Months Ended Twelve Months
Ended December 31, December 31, 2015
2014 2015 2014 Revenues:
Net product revenues $ 123,717 $ 110,630 $ 466,111 $ 373,292
Royalty revenues 4,921 4,978 17,492 19,131 License revenue
2,264 2,264 9,057 9,057
Total revenues 130,902 117,872 492,660 401,480 Costs
and expenses: Cost of sales 26,401 24,977 92,297 79,981 Cost of
license revenue 159 158 634 634 Research and development 43,988
25,921 149,209 73,470 Selling, general and administrative 52,984
56,456 205,630 201,813 Asset Impairment - 6,991 - 6,991 Change in
fair value of acquired contingent consideration 3,500
2,200 10,900 2,200 Total
operating expenses 127,032 116,703 458,670 365,089
Operating income $ 3,871 $ 1,169 $ 33,990 $ 36,391
Other expense, net (3,216 ) (3,862 )
(14,621 ) (8,382 ) Income (loss) before income taxes 655
(2,693 ) 19,369 28,009 Benefit from (provision for) income taxes
8,550 3,024 (8,311 ) (10,337 ) Net
income $ 9,205 $ 331 $ 11,058 $ 17,672
Net income per common share - basic $ 0.22 $ 0.01 $ 0.26 $
0.43 Net income per common share - diluted $ 0.21 $ 0.01 $ 0.25 $
0.42 Weighted average per common share - basic 42,624 41,532 42,230
41,150 Weighted average per common share - diluted 44,179 43,135
43,621 42,544
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, 2015
2014 2015 2014 GAAP net
income $ 9,205 $ 331 $ 11,058 $ 17,672 Pro forma adjustments:
Non-cash interest expense (1) 2,178 2,065 8,562 4,291
Non-cash tax expense (2) (11,095 ) (5,551 ) 3,614 5,981
Change in fair value of acquired contingent consideration (3) 3,500
2,200 10,900 2,200 Change in revenue recognition - Zanaflex
capsules & tablets (4) - - (21,633 ) - Acquisition
related expenses (5) - 4,893 - 7,248 Asset Impairment (6) -
6,991 - 6,991 Share-based compensation expenses included in
R&D 2,243 1,851 8,474 5,939 Share-based compensation expenses
included in SG&A 6,476 6,943
24,992 23,498 Total share-based compensation expenses
8,719 8,794 33,466 29,437 Total pro
forma adjustments 3,302 19,392 34,909 56,148
Non-GAAP net income $ 12,507 $ 19,723 $ 45,967
$ 73,820 Net income per common share - basic $ 0.29 $
0.47 $ 1.09 $ 1.79 Net income per common share - diluted $ 0.28 $
0.46 $ 1.05 $ 1.74 Weighted average per common share - basic 42,624
41,532 42,230 41,150 Weighted average per common share - diluted
44,179 43,135 43,621 42,544 (1) Non-cash interest expense
related to convertible senior notes. (2) $2.5 million and $2.5
million paid in cash taxes in the three months ended 2015 and 2014,
respectively, and $4.7 million and $4.4 million paid in cash taxes
in the twelve months ended 2015 and 2014, respectively. (3) Changes
in fair value of the acquired contingent consideration related to
the Civitas acquisition. (4) Change from "sell-through" (deferred)
method of revenue recognition to "sell-in" (traditional) method of
revenue recognition. (5) Transaction related expenses for the
Civitas acquisition. (6) Non-cash charge for NP-1998 impairment due
to reprioritization of R&D activities in Q4 2014.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160211005486/en/
Acorda TherapeuticsFelicia Vonella,
914-326-5146fvonella@acorda.com
Acorda Therapeutics (NASDAQ:ACOR)
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