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”
“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® (tizanidine
hydrochloride) and ZANAFLEX®
(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.
Cost of License Revenue - For the
quarter ended December 31, 2009, the Company recorded cost of license
revenue of $0.2 million and for the full year ended December 31, 2009,
the Company recorded cost of license revenue of $0.3 million. This cost
is 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 term of
the collaboration agreement as the related revenue is recognized.
Research and development expenses
for the quarter ended December 31, 2009 were $10.6 million, including
$1.1 million of share-based compensation, compared to $10.8 million
including $0.7 million of share-based compensation for the same quarter
in 2008. Research and development expenses for the full year ended
December 31, 2009 were $34.6 million, including $3.7 million of
share-based compensation, compared to $36.6 million including $2.3
million of share-based compensation in 2008. Research and development
expense for the full year ended December 31, 2009 included costs related
to our AMPYRA Phase 3 and long-term extension studies, preparation for
the AMPYRA NDA filing and FDA Advisory Committee meeting for AMPYRA and
development of our preclinical pipeline products.
Sales, general and administrative expenses
for the quarter ended December 31, 2009 were $22.7 million, including
$2.3 million of share-based compensation, compared to $19.6 million
including $2.0 million of share-based compensation for the same quarter
in 2008. Sales, general and administrative expenses for the full year
ended December 31, 2009 were $89.9 million, including $8.6 million of
share-based compensation, compared to $73.3 million including $7.5
million of share-based compensation in 2008. This increase in expenses
was primarily due to increases in AMPYRA pre-launch activities and
ZANAFLEX CAPSULES promotional activities.
Other income (expense), net for
the quarter ended December 31, 2009 was $(0.4) million compared to $0.6
million for the same quarter in 2008. Other income (expense) for the
full year ended December 31, 2009 was $(2.7) million compared to $(0.9)
million in 2008.
The Company reported a net loss of $22.5 million for the quarter ended
December 31, 2009, or $0.59 per diluted common share, compared to a net
loss of $20.2 million, or $0.54 per diluted common share, for the same
quarter in 2008. The Company reported a net loss of $83.9 million for
the full year ended December 31, 2009, or $2.22 per diluted common
share, compared to a net loss of $74.3 million, or $2.19 per diluted
common share, in 2008.
As of December 31, 2009, Acorda held cash, cash equivalents and
short-term investments of $272.1 million, compared to $246.0 million at
December 31, 2008.
Significant Events for 2009 and 2010 to Date
AMPYRA