- 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/
Acorda TherapeuticsFelicia Vonella,
914-326-5146fvonella@acorda.com
Acorda Therapeutics (NASDAQ:ACOR)
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