-
AMPYRA® (dalfampridine) 1Q 2016 net revenue of $109.6
Million; 19% increase over 1Q 2015 net revenue of $92.4 Million
-
Company exceeds 90% minimum condition to close Biotie acquisition;
final close expected in 2H 2016
-
Diversified portfolio with potential for three NDA filings by the end
of 2018
Acorda Therapeutics, Inc. (Nasdaq:ACOR)
today provided a financial and pipeline update for the first quarter
ended March 31, 2016.
AMPYRA® (dalfampridine) 1Q 2016 net revenue was $109.6
Million, a 19% increase over 1Q 2015 net revenue of $92.4 Million. In
January 2016, the Company announced an agreement to acquire Biotie, and
has received more than 90% of Biotie’s outstanding shares in the tender
offer. The Company expects to complete the purchase of 100% of Biotie’s
shares in the second half of this year.
“We are well into our transition from a single-product company to a
well-diversified biopharmaceutical enterprise, focused on developing
therapies to benefit patients with neurological conditions across
multiple disease states, including multiple sclerosis, Parkinson’s
disease, stroke, migraine and epilepsy,” said Ron Cohen, M.D., Acorda's
President and CEO. “Through our business development activities and
advancement of our clinical pipeline, we now have four promising Phase 3
assets and, pending successful trial results, have the potential to file
for approval of three of these by the end of 2018.”
Financial Results
The Company reported a GAAP net loss of $0.5 million for the quarter
ended March 31, 2016, or $0.01 per diluted share. The GAAP net loss in
the same quarter of 2015 was $3.1 million, or $0.07 per diluted share.
Non-GAAP net income for the quarter ended March 31, 2016 was $3.1
million, or $0.07 per diluted share. Non-GAAP net income in the same
quarter of 2015 was $6.5 million, or $0.15 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, unrealized
foreign currency transaction gains, and non-cash tax benefits. 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 March 31, 2016, the Company reported AMPYRA net
revenue of $109.6 million, up 19% compared to $92.4 million for the same
quarter in 2015.
ZANAFLEX CAPSULES® (tizanidine hydrochloride), ZANAFLEX®
(tizanidine hydrochloride) tablets and authorized generic capsules - For
the quarter ended March 31, 2016, the Company reported combined net
revenue and royalties from ZANAFLEX and tizanidine of $1.2 million
compared to $2.6 million for the same quarter in 2015.
FAMPYRA® (prolonged-release fampridine tablets) - For the
quarter ended March 31, 2016, the Company reported FAMPYRA royalties
from sales outside of the U.S. of $2.5 million, compared to $2.3 million
for the same quarter in 2015.
Research and development (R&D) expenses for the quarter ended March 31,
2016 were $44.6 million, including $2.1 million of share-based
compensation, compared to $30.6 million, including $1.8 million of
share-based compensation, for the same quarter in 2015.
Selling, general and administrative (SG&A) expenses for the quarter
ended March 31, 2016 were $51.8 million, including $6.0 million of
share-based compensation, compared to $48.8 million including $5.3
million of share-based compensation for the same quarter in 2015.
Acquisition related expenses for the Biotie transaction incurred in the
quarter ended March 31, 2016 were $7.2 million.
Benefit from income taxes for the quarter ended March 31, 2016 was $9.7
million, including $0.2 million of cash taxes, compared to $2.0 million,
including $0.7 million of cash taxes for the same quarter in 2015.
At March 31, 2016, prior to the closing of the Biotie acquisition, the
Company had cash, cash equivalents and investments of $431.4 million, up
from $353.3 million at December 31, 2015. In January 2016, the Company
completed a $75.0 million private placement of its common stock.
First Quarter 2016 Highlights
|
|
-
|
|
AMPYRA revenues for the first quarter of 2016 were $109.6 million,
up 19% from the first quarter in 2015. This represents the 12th
consecutive quarter of double digit, year-over-year growth for
AMPYRA, which was launched in 2010.
|
|
|
-
|
|
In March, a Markman hearing was held in the U.S. District Court
for the District of Delaware related to the consolidated lawsuits
that the Company filed against companies that submitted
Abbreviated New Drug Applications to the FDA seeking marketing
approval for AMPYRA. Also in March, the United States Patent and
Trademark Office (USPTO) Patent Trials and Appeal Board (PTAB)
instituted the inter partes review (IPR) of four AMPYRA patents.
Rulings on the IPR petitions are expected within one year. The
Company will continue to defend its intellectual property
vigorously.
|
-
Dalfampridine in Post-Stroke Walking Difficulty
|
|
-
|
|
In March, the Company completed Phase 1 single-dose pharmacokinetic
(PK) studies for three separate once-daily (QD) formulations of
dalfampridine. Results for at least one of these formulations met
the Company’s criteria. The multi-dose phase of PK testing will
begin in the second quarter of 2016.
|
|
|
-
|
|
Given the progress in its development of a QD formulation of
dalfampridine, the Company has made the decision to stop enrollment
and conduct an unblinded analysis of the Phase 3 twice-daily (BID)
clinical trial data, having reached 50% of its target enrollment in
the study, or 270 subjects. As previously stated, unblinding the
study ahead of the originally contemplated interim futility analysis
was an option. Data are expected by the fourth quarter of 2016 and
will be used to inform the design of planned Phase 3 trials in
post-stroke.
|
-
CVT-301 in Parkinson’s Disease
|
|
-
|
|
In April, data from the CVT-301 Phase 2b clinical trial were one of
six platform presentations highlighted during the Movement Disorders
Invited Science Session at the 68th Annual Meeting of the American
Academy of Neurology.
|
|
|
-
|
|
In March, the Company announced it had successfully completed a
Phase 1 safety/tolerability and pharmacokinetic study for CVT-427.
Based on the positive results, the Company is designing protocols
for the next phase of development.
|
|
|
-
|
|
In January, the Company announced it had entered into an agreement
to acquire Biotie Therapies Corp. The acquisition includes global
rights to two clinical-stage compounds in development for
treatment of Parkinson’s disease, as well as other assets.
|
|
|
-
|
|
In April, more than 90% of the outstanding shares of Biotie were
tendered to the Company in a tender offer conducted pursuant to
the acquisition agreement, meeting the minimum condition to
closing the tender offer. The Company expects to complete the
acquisition of 100% of Biotie in the second half of 2016.
|
|
|
-
|
|
In January, the Company completed a $75 million private placement
of its common stock and signed a Commitment Letter with JP Morgan
for an asset-based credit facility of up to $60 million, which is
expected to close in the second quarter of 2016.
|
The Company will host a conference call today at 8:30 a.m. ET to review
its first quarter 2016 results.
To participate in the conference call, please dial (855) 542-4209
(domestic) or (412) 455-6054 (international) and reference the access
code 81540360. The presentation will be available via a live webcast on
the Investors section of www.acorda.com.
Please log in approximately 5 minutes before the scheduled time of the
presentation to ensure a timely connection.
A replay of the call will be available from 11:30 a.m. ET on April 28,
2016 until 11:59 p.m. ET on May 5, 2016. To access the replay, please
dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and
reference the access code 81540360. 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 Parkinson’s disease,
epilepsy, post-stroke walking difficulty, migraine, and multiple
sclerosis. Acorda markets three FDA-approved therapies, including
AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg.
For more information, please visit the Company’s website at: www.acorda.com.
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; 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 (diazepam) Nasal Spray, 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 will acquire when 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 collaborator 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 benefits related to our tax accounting
which do not correlate to our actual tax payment obligations, (v)
unrealized foreign currency transaction gains, and (vi) acquisition
related expenses. 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)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
December 31,
|
|
|
|
|
|
|
|
2016
|
|
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, short-term and long-term investments
|
|
|
|
|
$
|
431,414
|
|
|
$
|
353,305
|
|
Trade receivable, net
|
|
|
|
|
|
41,623
|
|
|
|
31,466
|
|
Other current assets
|
|
|
|
|
|
31,577
|
|
|
|
30,070
|
|
Finished goods inventory
|
|
|
|
|
|
39,667
|
|
|
|
36,476
|
|
Deferred tax asset
|
|
|
|
|
|
12,273
|
|
|
|
2,128
|
|
Property and equipment, net
|
|
|
|
|
|
38,027
|
|
|
|
40,204
|
|
Goodwill
|
|
|
|
|
|
183,636
|
|
|
|
183,636
|
|
Intangible assets, net
|
|
|
|
|
|
430,491
|
|
|
|
430,856
|
|
Other assets
|
|
|
|
|
|
2,986
|
|
|
|
3,153
|
|
Total assets
|
|
|
|
|
$
|
1,211,694
|
|
|
$
|
1,111,294
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity
|
|
|
|
|
|
|
|
|
|
Accounts payable, accrued expenses and other liabilities
|
|
|
|
|
$
|
94,830
|
|
|
$
|
80,366
|
|
Current portion of deferred license revenue
|
|
|
|
|
|
9,057
|
|
|
|
9,057
|
|
Current portion of revenue interest liability
|
|
|
|
|
|
-
|
|
|
|
25
|
|
Current portion of notes payable
|
|
|
|
|
|
1,117
|
|
|
|
1,144
|
|
Convertible senior notes
|
|
|
|
|
|
292,624
|
|
|
|
290,420
|
|
Contingent consideration
|
|
|
|
|
|
69,700
|
|
|
|
63,500
|
|
Non-current portion of deferred license revenue
|
|
|
|
|
|
39,249
|
|
|
|
41,513
|
|
Deferred tax liability
|
|
|
|
|
|
12,146
|
|
|
|
12,146
|
|
Other long-term liabilities
|
|
|
|
|
|
8,959
|
|
|
|
10,098
|
|
Stockholders' equity
|
|
|
|
|
|
684,012
|
|
|
|
603,025
|
|
Total liabilities and stockholders' equity
|
|
|
|
|
$
|
1,211,694
|
|
|
$
|
1,111,294
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acorda Therapeutics, Inc.
Consolidated Statements of Operations
(in thousands, except per share amounts)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
|
|
|
March 31,
|
|
|
|
|
|
|
|
2016
|
|
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
Net product revenues
|
|
|
|
|
$
|
110,148
|
|
|
$
|
93,500
|
|
|
Royalty revenues
|
|
|
|
|
|
3,492
|
|
|
|
4,087
|
|
|
License revenue
|
|
|
|
|
|
2,264
|
|
|
|
2,264
|
|
|
Total revenues
|
|
|
|
|
|
115,904
|
|
|
|
99,851
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
Cost of sales
|
|
|
|
|
|
23,186
|
|
|
|
18,446
|
|
|
Cost of license revenue
|
|
|
|
|
|
159
|
|
|
|
159
|
|
|
Research and development
|
|
|
|
|
|
44,570
|
|
|
|
30,636
|
|
|
Selling, general and administrative
|
|
|
|
|
|
51,782
|
|
|
|
48,769
|
|
|
Acquisition related expenses
|
|
|
|
|
|
7,198
|
|
|
|
-
|
|
|
Change in fair value of acquired contingent consideration
|
|
|
|
|
|
6,200
|
|
|
|
3,100
|
|
|
Total operating expenses
|
|
|
|
|
|
133,095
|
|
|
|
101,110
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
|
|
|
$
|
(17,191
|
)
|
|
$
|
(1,259
|
)
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net
|
|
|
|
|
|
6,934
|
|
|
|
(3,864
|
)
|
|
Loss before income taxes
|
|
|
|
|
|
(10,257
|
)
|
|
|
(5,123
|
)
|
|
Benefit from income taxes
|
|
|
|
|
|
9,737
|
|
|
|
2,038
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
$
|
(520
|
)
|
|
$
|
(3,085
|
)
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share - basic
|
|
|
|
|
$
|
(0.01
|
)
|
|
$
|
(0.07
|
)
|
|
Weighted average per common share - basic
|
|
|
|
|
|
44,815
|
|
|
|
42,031
|
|
|
|
|
|
|
|
|
|
|
Acorda Therapeutics, Inc.
Non-GAAP Income and Income per Common Share
Reconciliation
(in thousands, except per share amounts)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
|
|
|
March 31,
|
|
|
|
|
|
|
|
2016
|
|
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss
|
|
|
|
|
$
|
(520
|
)
|
|
$
|
(3,085
|
)
|
|
Pro forma adjustments:
|
|
|
|
|
|
|
|
|
Non-cash interest expense (1)
|
|
|
|
|
|
2,204
|
|
|
|
2,103
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash tax benefit (2)
|
|
|
|
|
|
(9,894
|
)
|
|
|
(2,781
|
)
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of acquired contingent consideration (3)
|
|
|
|
|
|
6,200
|
|
|
|
3,100
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition related expenses (4)
|
|
|
|
|
|
7,198
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized foreign currency transaction gain (5)
|
|
|
|
|
|
(10,289
|
)
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expenses included in R&D
|
|
|
|
|
|
2,121
|
|
|
|
1,822
|
|
|
Share-based compensation expenses included in SG&A
|
|
|
|
|
|
6,038
|
|
|
|
5,304
|
|
|
Total share-based compensation expenses
|
|
|
|
|
|
8,159
|
|
|
|
7,126
|
|
|
|
|
|
|
|
|
|
|
|
Total pro forma adjustments
|
|
|
|
|
|
3,578
|
|
|
|
9,548
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income
|
|
|
|
|
$
|
3,058
|
|
|
$
|
6,463
|
|
|
|
|
|
|
|
|
|
|
|
Net income per common share - basic
|
|
|
|
|
$
|
0.07
|
|
|
$
|
0.15
|
|
|
Net income per common share - diluted
|
|
|
|
|
$
|
0.07
|
|
|
$
|
0.15
|
|
|
Weighted average per common share - basic
|
|
|
|
|
|
44,815
|
|
|
|
42,031
|
|
|
Weighted average per common share - diluted
|
|
|
|
|
|
46,043
|
|
|
|
43,585
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Non-cash interest expense related to convertible senior notes.
|
|
(2) $0.2 million and $0.7 million paid in cash taxes in the three
months ended March 31, 2016 and 2015, respectively.
|
|
(3) Changes in the fair value of the acquired contingent
consideration related to the Civitas acquisition.
|
|
(4) Transaction expenses related to the Biotie acquisition.
|
|
|
(5) Unrealized foreign currency transaction gain related to the
Biotie transaction included in Other income, net in the Consolidated
Statements of Operations.
|
View source version on businesswire.com: http://www.businesswire.com/news/home/20160428005510/en/
Copyright Business Wire 2016