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Nasdaq
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(R) (tizanidine hydrochloride),
a short-acting drug for the management of spasticity. Acorda's lead clinical
product, Fampridine-SR, is in Phase3 clinical trials to evaluate its safety
and efficacy to improve walking ability in people with MS. The Company's
pipeline includes a number of products in development for the treatment,
regeneration and repair of the spinal cord and brain.
http://www.acorda.com
Acorda
Therapeutics Reports Fourth Quarter and Full Year 2009 Financial Results
Announced
FDA Approval of AMPYRATM (dalfampridine) Extended Release
Tablets,
10 mg on January 22, 2010 to Improve Walking in People with
Multiple
Sclerosis (MS); Demonstrated by Increase in Walking Speed
AMPYRA
Commercial Launch Expected March 2010
IND
Filing for GGF2 in Heart Failure Expected Early 2010
HAWTHORNE,
N.Y., Feb 23, 2010 (BUSINESS WIRE) -- Acorda Therapeutics, Inc. (Nasdaq:
ACOR) today announced its financial results for the fourth quarter and
full year ended December 31, 2009.
"The
FDA approval of AMPYRA represents an important advance in the treatment
of MS. It is also a significant step for Acorda toward our goal of becoming
a leading innovator in neurology," said Ron Cohen, M.D., President and
CEO of Acorda Therapeutics. "We expect commercial supply of AMPYRA to be
available beginning in March. As we launch AMPYRA, we also are focusing
on advancing our preclinical pipeline to the clinic. We believe GGF2 may
have important applications in both cardiac and neurological conditions,
and will look to demonstrate proof of concept initially in heart failure.
We expect to file an IND for this indication in early 2010."
Financial
Results and Product Update
ZANAFLEX
CAPSULES(R) (tizanidine hydrochloride) and ZANAFLEX(R) (tizanidine hydrochloride)
tablets gross sales - For the fourth quarter ended December 31, 2009, the
Company reported combined gross sales of ZANAFLEX CAPSULES and ZANAFLEX
tablets of $14.4 million, compared to combined gross sales of $14.0 million
for the same quarter in 2008. For the full year ended December 31, 2009,
the Company reported combined gross sales of ZANAFLEX CAPSULES and ZANAFLEX
tablets of $58.3 million, compared to combined gross sales of $53.4 million
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. ZANAFLEX franchise
operations were cash flow positive on an operating basis for 2009.
ZANAFLEX
CAPSULES and ZANAFLEX tablets shipments - Total ZANAFLEX CAPSULES and ZANAFLEX
tablet shipments for the quarter ended December 31, 2009 were $18.4 million,
compared to total shipments of $16.5 million for the same quarter in 2008.
For the full year ended December 31, 2009, total ZANAFLEX CAPSULES and
ZANAFLEX tablet shipments were $66.7million, compared to total shipments
of $62.9 million in 2008.
License
Revenue - For the quarter ended December 31, 2009, the Company reported
license revenue of $2.4 million, a portion of the $110 million received
from Biogen Idec International GmbH (Biogen Idec), a subsidiary of Biogen
Idec Inc., for the collaboration agreement entered into on June 30, 2009.
For the full year ended December 31, 2009, the Company reported license
revenue of $4.7 million. The balance of this payment will be recognized
as revenue ratably over the remainder of the estimated term of the collaboration
agreement.
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