-
Acorda and Biogen Idec Agree to Fampridine-SR Ex-U.S. Collaboration
on June 30, 2009
-
Upfront Payment of $110 Million; Potential Deal Value Over $500
Million
-
Company Notified by U.S. Food and Drug Administration (FDA) that
Advisory Committee Meeting Will be Held for Fampridine-SR
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced its financial
results for the second quarter of 2009.
“A very productive second quarter was highlighted by the completion of
our ex-U.S. collaboration with Biogen Idec, which we believe could
benefit people with MS as well as Acorda shareholders. Biogen Idec has
the capabilities and expertise to maximize the value of Fampridine-SR in
ex-US markets, if approved, and to make it available to patients around
the world who can potentially benefit from it,” said Ron Cohen, M.D.,
Acorda Therapeutics’ President and CEO. “To continue to build
shareholder value, in addition to advancing the Fampridine-SR program we
are moving two of our preclinical product candidates towards INDs, and
working to identify later stage product opportunities for potential
acquisition.”
Financial Results and Product Update
Zanaflex Capsules®
(tizanidine hydrochloride) and Zanaflex®
(tizanidine hydrochloride) Tablets gross sales - For the quarter
ended June 30, 2009, the Company reported combined gross sales of
Zanaflex Capsules and Zanaflex tablets of $14.8 million, compared to
combined gross sales of $13.1 million for the same quarter in 2008.
Gross sales are recognized using a deferred revenue recognition model,
meaning Zanaflex Capsules and Zanaflex tablet shipments to wholesalers
are recorded as deferred revenue and only recognized as revenue when
end-user prescriptions of Zanaflex Capsules and Zanaflex tablets are
reported. A slight downward trend in prescriptions was observed over the
first two quarters of 2009.
Zanaflex Capsules and Zanaflex Tablets
shipments - Total Zanaflex Capsules and Zanaflex tablet shipments
for the quarter ended June 30, 2009 were $16.6 million, compared to
total shipments of $16.0 million for the same quarter in 2008.
Research and development expenses
for the quarter ended June 30, 2009 were $7.9 million, including $0.9
million of share-based compensation, compared to $8.1 million including
$0.6 million of share-based compensation for the same quarter in 2008.
The decrease in research and development expenses for the quarter ended
June 30, 2009 was primarily due to the conclusion of the second Phase 3
Fampridine-SR study in Q2 2008 offset by increased expenses related to
the development of the Company’s preclinical pipeline products.
Sales, general and administrative expenses
for the quarter ended June 30, 2009 were $23.9 million, including $2.1
million of share-based compensation, compared to $17.6 million including
$1.8 million of share-based compensation for the same quarter in 2008.
This increase in expenses was primarily due to increases in
Fampridine-SR pre-launch activities and SG&A staff and compensation.
Sales, general and administrative expenses are expected to increase in
2009 compared to 2008, primarily due to an increase in the Company’s
expected pre-launch costs.
Collaboration accounting - For the
quarter ended June 30, 2009, the Company recorded a license revenue
receivable and deferred revenue of $110.0 million for the upfront
payment due to Acorda from Biogen Idec for the collaboration agreement
entered into on June 30, 2009, for the development and commercialization
of Fampridine-SR in markets outside of the U.S. Also, as a result of
this collaboration agreement, a payment of $7.7 million became payable
by Acorda to Elan and was recorded as a cost of license revenue payable
and deferred expense recorded in other assets. The license payment of
$110.0 million was received from Biogen on July 1, 2009 and the payment
of $7.7 million was made to Elan on July 7, 2009. Given the multiple
components of the contract, the Company is assessing the accounting
implications of these transactions.
The Company reported a net loss of $23.3 million for the quarter ended
June 30, 2009, or $0.62 per diluted common share, compared to a net loss
of $18.8 million, or $0.58 per basic and diluted common share, for the
same quarter in 2008.
As of June 30, 2009 Acorda held cash, cash equivalents, and short-term
investments of $212.4 million. The Company expects this balance, in
addition to the net proceeds of $102.3 million from the Biogen
collaboration agreement, will provide a year-end 2009 cash, cash
equivalents and short-term investment balance in excess of $250 million.
Fampridine-SR Update
-
Acorda and Biogen Idec announced an ex-U.S. collaboration to develop
and commercialize Fampridine-SR on July 1. Under the terms of the
agreement, Acorda received an upfront payment of $110 million and can
receive additional payments of up to $400 million based on the
successful achievement of future regulatory and sales milestones.
Biogen Idec will make tiered, double-digit royalty payments to Acorda
on ex-U.S. sales. Biogen will be responsible for all development and
commercialization activities outside the U.S.
-
The FDA accepted the Fampridine-SR NDA for filing on May 5, 2009 and
assigned it Priority Review with a Prescription Drug User Fee Act
(PDUFA) date of October 22, 2009.
-
The FDA has notified the Company that a Peripheral and Central Nervous
System Drugs Advisory Committee meeting will be held for
Fampridine-SR. The date of the meeting will be posted in the Federal
Register when finalized.
-
Acorda received notification from the European Medicines Agency (EMEA)
that Fampridine-SR is eligible to be submitted for a centralized
filing, and also qualifies as a New Active Substance (NAS), which
confers 10 years of market exclusivity if approved. The Company also
disclosed the submission of an Intent to File letter to the EMEA on
April 8, 2009.
-
Data from Fampridine-SR extension studies have been accepted for a
platform presentation at the 25th Congress of the European
Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)
on September 10. Data from the Fampridine-SR thorough QT study will
also be presented at the meeting, being held September 9-12 in
Dusseldorf, Germany.
-
Data on the extension studies have also been accepted for presentation
at the 13th Congress of the European Federation of
Neurological Societies (EFNS), being held September 12-15 in Florence,
Italy.
-
As of June 30, 2009, 177 subjects from MS-F202 had been enrolled in an
extension trial and 84, or approximately 47 percent, remained active
in the trial, with duration of treatment ranging from 3.39 to 5.32
years. As of the same date, 269 patients from MS-F203 had been
enrolled in a separate extension study and 180 of these, or
approximately 66.9 percent, remained active, with duration of
treatment ranging from 1.08 to 3.59 years. Also, as of this same date,
214 patients from MS-F204 had been enrolled in a third extension study
and 176, or approximately 82 percent, remained active, with duration
of treatment ranging from 14.33 months to 22.43 months. The total
exposure to Fampridine-SR in our MS studies to date, including both
double-blind and open label studies, is approximately 1750
patient-years.
-
To ensure consistency of reporting, adverse event terms were
standardized across all studies. Below is an updated table of adverse
events for the three key controlled MS studies, MS-F202, MS-F203 and
MS-F204.
MS-F202, MS-F203 and MS-F204: Most Frequent (>5%) Adverse Events
|
|
|
Placebo (N = 238)
|
|
|
Fampridine-SR 10 mg BID (N = 400)
|
|
Falls
|
|
16.4
|
%
|
|
|
16.0
|
%
|
|
Urinary tract infection
|
|
9.2
|
%
|
|
|
14.5
|
%
|
|
Insomnia
|
|
3.8
|
%
|
|
|
9.3
|
%
|
|
Asthenia
|
|
4.2
|
%
|
|
|
8.3
|
%
|
|
Dizziness
|
|
4.2
|
%
|
|
|
7.8
|
%
|
|
Headache
|
|
4.2
|
%
|
|
|
7.5
|
%
|
|
Nausea
|
|
2.5
|
%
|
|
|
7.0
|
%
|
|
Fatigue
|
|
4.6
|
%
|
|
|
6.5
|
%
|
|
Upper Resp. Tract Inf.
|
|
7.1
|
%
|
|
|
5.8
|
%
|
|
Balance disorder
|
|
1.3
|
%
|
|
|
5.8
|
%
|
|
Back pain
|
|
2.1
|
%
|
|
|
5.5
|
%
|
|
MS relapse
|
|
3.8
|
%
|
|
|
5.3
|
%
|
Some of the percentages reported in earlier tables have changed, which
in some cases affects their rank order. The only new AE that now reports
at over 5% is MS relapse, at 5.3% for the Fampridine-SR treated group,
vs. 3.8% for placebo. The imbalance between treatment groups for this
event was due to worsening of MS symptoms occurring after
discontinuation of drug.
Corporate Update
-
Acorda supported a study by the North American Research Committee on
Multiple Sclerosis (NARCOMS) that showed people with multiple
sclerosis (MS) experience reduced income and earning potential as
their mobility impairment increases. The data were presented at the
American Academy of Neurology (AAN) 61st Annual Meeting in
April 2009.
Webcast and Conference Call
Ron Cohen, President and Chief Executive Officer, and David Lawrence,
Chief Financial Officer, will host a conference call today at 8:30 a.m.
ET to review the Company’s second quarter 2009 results.
To participate in the conference call, please dial 866-804-6925
(domestic) or 857-350-1671 (international) and reference the access code
65868262. The presentation will be available via a live webcast at:
http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetails&c=194451&eventID=2331061
A replay of the call will be available from 12:30 p.m. ET on August 4,
2009 until midnight on August 25, 2009. To access the replay, please
dial 888-268-8010 (domestic) or 617-801-6888 (international) and
reference the access code 68339805. The archived webcast will be
available for 30 days in the Investor Relations section of the Acorda
website at http://www.acorda.com.
About Fampridine-SR
Fampridine-SR is a sustained-release tablet formulation of the
investigational drug fampridine (4-aminopyridine or 4-AP). In laboratory
studies, fampridine has been found to improve impulse conduction in
nerve fibers in which the insulating layer, called myelin, has been
damaged.
About Acorda Therapeutics
Acorda Therapeutics is a biotechnology company developing therapies for
spinal cord injury, multiple sclerosis and related nervous system
disorders. The Company's marketed products include Zanaflex Capsules®
(tizanidine hydrochloride), a short-acting drug for the management of
spasticity. The Company's pipeline includes a number of products in
development for the treatment, regeneration and repair of the spinal
cord and brain.
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 delays in obtaining or failure to obtain FDA approval of
Fampridine-SR, the risk of unfavorable results from future studies of
Fampridine-SR, Acorda Therapeutics' ability to successfully market and
sell Fampridine-SR, if approved, and Zanaflex Capsules, competition,
failure to protect its intellectual property or to defend against the
intellectual property claims of others, the ability to obtain additional
financing to support Acorda Therapeutics' operations, and unfavorable
results from its preclinical programs. These and other risks are
described in greater detail in Acorda Therapeutics' filings with the
Securities and Exchange Commission. Acorda Therapeutics may not actually
achieve the goals or plans described in its forward-looking statements,
and investors should not place undue reliance on these statements.
Acorda Therapeutics disclaims any intent or obligation to update any
forward-looking statements as a result of developments occurring after
the date of this press release.
Financial Statements
|
Acorda Therapeutics, Inc
|
|
Condensed Consolidated Balance Sheet Data
|
|
(in thousands)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
June 30,
|
|
December 31,
|
|
|
2009
|
|
2008
|
|
|
|
|
|
|
Assets
|
|
|
|
|
Cash, cash equivalents and short-term investments
|
$
|
212,395
|
|
$
|
246,049
|
|
License revenue receivable
|
|
110,000
|
|
|
-
|
|
Trade receivable, net
|
|
5,470
|
|
|
4,762
|
|
Other current assets
|
|
7,096
|
|
|
5,094
|
|
Finished goods inventory
|
|
6,072
|
|
|
6,144
|
|
Property and equipment, net
|
|
3,044
|
|
|
2,348
|
|
Intangible assets, net
|
|
15,924
|
|
|
16,565
|
|
Other assets
|
|
8,169
|
|
|
539
|
|
Total assets
|
$
|
368,170
|
|
$
|
281,501
|
|
|
|
|
|
|
Liabilities and stockholders' equity
|
|
|
|
|
Accounts payable, accrued expenses and other liabilities
|
$
|
25,809
|
|
$
|
24,119
|
|
Cost of license revenue payable
|
|
7,700
|
|
|
-
|
|
Deferred product revenue
|
|
26,819
|
|
|
24,304
|
|
Current portion of revenue interest liability
|
|
7,258
|
|
|
6,181
|
|
Deferred license revenue
|
|
110,000
|
|
|
-
|
|
Long term notes payable
|
|
7,008
|
|
|
6,905
|
|
Non-current portion of revenue interest liability
|
|
11,779
|
|
|
12,835
|
|
Stockholders' equity
|
|
171,797
|
|
|
207,157
|
|
Total liabilities and stockholders' equity
|
$
|
368,170
|
|
$
|
281,501
|
|
Acorda Therapeutics, Inc
|
|
Consolidated Statements of Operations
|
|
(in thousands, except per share amounts)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
Six Months Ended
|
|
|
June 30,
|
|
June 30,
|
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross sales - Zanaflex
|
$
|
14,754
|
|
|
$
|
13,099
|
|
|
$
|
29,372
|
|
|
$
|
25,775
|
|
|
Less: discounts and allowances
|
|
(2,204
|
)
|
|
|
(1,740
|
)
|
|
|
(4,353
|
)
|
|
|
(2,929
|
)
|
|
Net sales
|
|
12,550
|
|
|
|
11,359
|
|
|
|
25,019
|
|
|
|
22,846
|
|
|
Grant revenue
|
|
-
|
|
|
|
27
|
|
|
|
-
|
|
|
|
53
|
|
|
Total net revenue
|
|
12,550
|
|
|
|
11,386
|
|
|
|
25,019
|
|
|
|
22,899
|
|
|
Cost of sales
|
|
(2,952
|
)
|
|
|
(2,830
|
)
|
|
|
(5,511
|
)
|
|
|
(5,816
|
)
|
|
Gross profit
|
|
9,598
|
|
|
|
8,556
|
|
|
|
19,508
|
|
|
|
17,083
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
Research and development
|
|
7,867
|
|
|
|
8,058
|
|
|
|
15,784
|
|
|
|
17,650
|
|
|
Sales and marketing
|
|
15,682
|
|
|
|
11,732
|
|
|
|
28,556
|
|
|
|
21,929
|
|
|
General and administrative
|
|
8,244
|
|
|
|
5,838
|
|
|
|
15,391
|
|
|
|
10,901
|
|
|
Total operating expenses
|
|
31,793
|
|
|
|
25,628
|
|
|
|
59,731
|
|
|
|
50,480
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
$
|
(22,195
|
)
|
|
$
|
(17,072
|
)
|
|
$
|
(40,223
|
)
|
|
$
|
(33,397
|
)
|
|
|
|
|
|
|
|
|
|
|
Other expense, net
|
|
(1,134
|
)
|
|
|
(1,750
|
)
|
|
|
(1,814
|
)
|
|
|
(1,856
|
)
|
|
Net loss
|
|
(23,329
|
)
|
|
|
(18,822
|
)
|
|
|
(42,037
|
)
|
|
|
(35,253
|
)
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share - basic and diluted
|
$
|
(0.62
|
)
|
|
$
|
(0.58
|
)
|
|
$
|
(1.12
|
)
|
|
$
|
(1.12
|
)
|
|
|
|
|
|
|
|
|
|
|
Weighted average per common share - basic and diluted
|
|
37,708
|
|
|
|
32,557
|
|
|
|
37,676
|
|
|
|
31,451
|
|
Acorda Therapeutics
Tierney Saccavino, 914-347-4300 ext. 104
tsaccavino@acorda.com
or
Acorda
Therapeutics
Jeff Macdonald, 914-347-4300 ext. 232
jmacdonald@acorda.com