(Source: Business Wire)

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced its financial
results for the third quarter of 2009.
"The positive vote from the FDA Advisory Committee was an important step
toward making Fampridine-SR available to people with multiple sclerosis
who may benefit from this novel therapy, if approved," said Ron Cohen,
M.D., Acorda Therapeutics' President and CEO. "We look forward to
continuing to work with the FDA as it completes its review of the
Fampridine-SR submission."
Financial Results and Product Update
Zanaflex Capsules®
(tizanidine hydrochloride) and Zanaflex®
(tizanidine hydrochloride) Tablets gross sales - For the quarter
ended September 30, 2009, the Company reported combined gross sales of
Zanaflex Capsules and Zanaflex tablets of $14.5 million, compared to
combined gross sales of $13.7 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. There has been a slight downward trend in prescriptions over
the first three quarters of 2009.
Zanaflex Capsules and Zanaflex Tablets
shipments - Total Zanaflex Capsules and Zanaflex tablet shipments
for the quarter ended September 30, 2009 were $15.3 million, compared to
total shipments of $15.7 million for the same quarter in 2008.
License Revenue - For the quarter
ended September 30, 2009, the Company reported license revenue of $2.4
million, a portion of the $110 million received from Biogen Idec for the
collaboration agreement entered into on June 30, 2009. The balance of
this payment will be recognized as revenue ratably over the remainder of
the estimated term of the collaboration agreement. The Company currently
estimates the revenue recognition period to be approximately 12 years.
Cost of License Revenue - For the
quarter ended September 30, 2009, the Company recorded cost of license
revenue of $0.2 million related to the $7.7 million payment made to Elan
as a result of the collaboration agreement the Company entered into with
Biogen Idec. This payment will be recognized as expense ratably over the
estimated 12 year term of the collaboration agreement as the related
revenue is recognized.
Research and development expenses
for the quarter ended September 30, 2009 were $8.2 million, including
$0.9 million of share-based compensation, compared to $8.7 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 September 30, 2009 was primarily due to a decrease in
regulatory and clinical development program expenses relating to
Fampridine-SR partially offset by increased expenses related to the
development of the Company's preclinical pipeline products.
Sales, general and administrative expenses
for the quarter ended September 30, 2009 were $23.3 million, including
$2.3 million of share-based compensation, compared to $20.4 million
including $2.1 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, medical affairs educational
programs and SG&A staff and compensation. Sales, general and
administrative expenses will continue to increase in 2009 compared to
2008, primarily due to an increase in the Company's expected pre-launch
costs.
The Company reported a net loss of $19.4 million for the quarter ended
September 30, 2009, or $0.51 per diluted common share, compared to a net
loss of $18.9 million, or $0.53 per diluted common share, for the same
quarter in 2008.
As of September 30, 2009 Acorda held cash, cash equivalents, and
short-term investments of $292.4 million. The Company expects this
balance will provide a year-end 2009 cash, cash equivalents and
short-term investment balance in excess of $250 million.
Fampridine-SR Update
On October 14, the Peripheral and Central Nervous System Drugs
Advisory Committee appointed by the FDA voted 12 to 1 that clinical
data on Fampridine-SR 10 mg twice daily demonstrated substantial
evidence of effectiveness as a treatment to improve walking in people
with multiple sclerosis (MS) and voted 10 to 2 (1 abstention) that it
is clinically meaningful and can be safe for use.
The Advisory Committee voted that lower doses of Fampridine-SR be
studied as part of a post-marketing commitment. In addition, the
Committee recommended against mandatory electroencephalography (EEG)
screenings for prospective Fampridine-SR patients.
On October 22, the FDA notified the Company that the October 22
Prescription Drug User Fee Act (PDUFA) goal date for the Fampridine-SR
New Drug Application (NDA) was being extended to January 22, 2010.