Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced its
financial results for the second quarter of 2008.
“Acorda continued to achieve important milestones in this
quarter,” said Ron Cohen, M.D., Acorda Therapeutics’ President and
CEO. “In June, we announced positive results of our second Phase 3
clinical trial of Fampridine-SR in multiple sclerosis, which were
consistent with the results of our successful first Phase 3 trial. We
are now focused on completing our New Drug Application, or NDA, which
we expect to file in the first quarter of 2009. In addition, our
Zanaflex franchise continued to deliver solid performance in the face
of a genericized market. This performance is a credit to the
effectiveness of our commercial team, which will also provide the
foundation for our commercial launch of Fampridine-SR, if approved.”
Financial Results and Product Update
Zanaflex Capsules(R) (tizanidine hydrochloride) and Zanaflex(R)
(tizanidine hydrochloride) Tablets Gross Sales - For the quarter ended
June 30, 2008, the Company reported combined gross sales of Zanaflex
Capsules and Zanaflex tablets of $13.1 million, compared to combined
gross sales of $10.5 million for the same quarter in 2007. 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 tablets are reported.
Zanaflex Capsules and Zanaflex Tablets Shipments - Total Zanaflex
Capsules and Zanaflex tablet shipments for the quarter ended June 30,
2008 were $ 16.0 million, compared to total shipments of $12.1 million
for the same quarter in 2007.
Research and development expenses for the quarter ended June 30,
2008 were $8.1 million, including $0.6 million of share-based
compensation, compared to $4.0 million including $0.3 million of
share-based compensation for the same quarter in 2007. Research and
development expense increases for the quarter ended June 30, 2008
include clinical trial costs related to our Fampridine-SR Phase 3
trial, costs related to the preparation for an NDA filing and
development of two of our preclinical pipeline products for potential
IND filings in late 2009.
Sales, general and administrative expenses for the quarter ended
June 30, 2008 were $17.6 million, including $1.8 million of
share-based compensation, compared to $11.6 million including $1.6
million of share-based compensation for the same quarter in 2007. This
increase in expenses is primarily due to increases in Zanaflex
Capsules promotional activities and Fampridine-SR pre-launch
activities. Sales, general and administrative expenses are expected to
continue to increase in 2008 and in 2009 primarily due to an increase
in our expected pre-launch costs.
Interest expense for the quarter ended June 30, 2008 was $2.8
million compared to $0.8 million for the same quarter in 2007. The
increase in interest expense is primarily due to a $1.4 million
non-cash adjustment to the effective interest expense recognition
related to the November 2006 amended revenue interests assignment
agreement with an affiliate of Paul Capital Healthcare (formerly Paul
Royalty Fund).
The Company reported a net loss of $18.8 million for the quarter
ended June 30, 2008, or $0.58 per diluted common share, compared to a
net loss of $8.2 million, or $0.33 per diluted common share, for the
same quarter in 2007.
As of June 30, 2008, Acorda held cash, cash equivalents and
short-term investments of $149.0 million, compared to $ 104.7 million
on June 30, 2007. This $149.0 million is expected to be sufficient to
fund the Company’s operations into the fourth quarter of 2009.
Fampridine-SR Update
On June 2, the Company announced positive results from its second
Phase 3 clinical trial of Fampridine-SR (MS-F204) on walking ability
in people with multiple sclerosis (MS). A significantly greater
proportion of people taking Fampridine-SR in the trial had a
consistent improvement in walking speed compared to people taking
placebo (42.9% vs. 9.3%), as measured by the Timed 25-Foot Walk (p
less than 0.001). Consistent improvement in walking speed was the
primary endpoint of the study as agreed upon in the Special Protocol
Assessment (SPA) with the U.S. Food and Drug Administration (FDA). The
study’s only prospectively defined secondary outcome measure, leg
strength, showed a statistically significant increase in the
Fampridine-SR Timed Walk responders compared to placebo (p = 0.028).
There was a small improvement in leg strength for Fampridine-SR Timed
Walk non-responders compared to placebo that was not statistically
significant.
The Company intends to present additional clinical results from
this trial in September at the World Congress on Treatment and
Research in Multiple Sclerosis.
As of July 18, 2008, 177 subjects from MS-F202 had been enrolled
in an extension trial and 101, or approximately 57 percent, remained
active in the trial, with duration of treatment ranging from 3.8 to
4.4 years. As of the same date, 269 patients from MS-F203 had been
enrolled in a separate extension study and 203 of these, or
approximately 75 percent, remained active, with duration of treatment
ranging from 1.8 to 2.6 years. Also, as of this same date, 214
patients from MS-F204 had been enrolled in a third extension study and
194, or approximately 89 percent, remained active, with a duration of
treatment ranging from one to 11 months. The total exposure to
Fampridine-SR in our MS studies to date, including both double-blind
and open label studies, is over 1,200 patient-years.
Corporate Update
Ron Cohen was appointed to the Executive Committee of the
Biotechnology Industry Organization (BIO). Dr. Cohen was also named
Vice Chair of the Emerging Companies Section of BIO. BIO is the
world’s largest biotechnology organization, providing advocacy,
business development and communications services for more than 1,200
members worldwide.
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 2008 results.
To participate in the conference call, please dial 866-356-3377
(domestic) or 617-597-5392 (international) and reference the access
code 76531596. The presentation will be available via a live webcast
at
http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetails&c=194451
&eventID=1907680. (Due to its length, this URL may need to be
copied/pasted into your Internet browser’s address field. Remove the
extra space if one exists.)
A replay of the call will be available from 10:30 a.m. ET on
August 5, 2008 until midnight on September 5, 2008. To access the
replay, please dial 888-286-8010 (domestic) or 617-801-6888
(international) and reference the access code 36885479. 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. Fampridine-SR recently completed a second
Phase 3 clinical trial to evaluate its safety and efficacy in
improving walking ability in people with MS.
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(R) (tizanidine hydrochloride), a short-acting drug
for the management of spasticity. Acorda’s lead clinical product,
Fampridine-SR, recently completed a second Phase 3 clinical trial to
evaluate its safety and efficacy in improving 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.
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,
2008 2007
——– ————
Assets
Cash, cash equivalents and short-term
investments $149,010 $ 95,121
Trade receivable, net 4,957 4,265
Other current assets 3,760 3,923
Finished goods inventory 6,475 7,724
Property and equipment, net 1,826 1,652
Intangible assets, net 17,751 13,944
Other assets 619 677
——– ————
Total assets $184,398 $127,306
======== ============
Liabilities and stockholders’ equity
Accounts payable, accrued expenses and other
liabilities $ 19,761 $ 15,453
Deferred product revenue 24,696 21,837
Current liabilities 1,880 1,973
Long term notes payable 6,804 6,703
Non-current portion of revenue interest
liability 18,845 17,907
Stockholders’ equity 112,412 63,433
——– ————
Total liabilities and stockholders’ equity $184,398 $127,306
——– ———— Acorda Therapeutics, Inc
Consolidated Statements of Operations
(in thousands, except per share amounts)
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
2008 2007 2008 2007
——— ——– ——— ———
Gross sales - Zanaflex $ 13,099 $10,499 $ 25,775 $ 19,304
Less: discounts and allowances (1,740) (1,014) (2,929) (1,509)
——— ——– ——— ———
Net sales 11,359 9,484 22,846 17,795
Grant revenue 27 10 53 16
——— ——– ——— ———
Total net revenue 11,386 9,494 22,899 17,811
Cost of sales (2,830) (2,011) (5,816) (3,565)
——— ——– ——— ———
Gross profit 8,556 7,484 17,083 14,246
Operating expenses:
Research and development 8,058 4,008 17,650 7,251
Sales and marketing 11,732 7,118 21,929 14,088
General and administrative 5,838 4,476 10,901 8,830
——— ——– ——— ———
Total operating expenses 25,628 15,602 50,480 30,169
——— ——– ——— ———
Operating loss $(17,072) $(8,118) $(33,397) $(15,923)
——— ——– ——— ———
Other income (expense), net (1,750) (46) (1,856) 211
——— ——– ——— ———
Net loss (18,822) (8,164) (35,253) (15,712)
========= ======== ========= =========
Net loss per common share -
basic and diluted $ (0.58) $ (0.33) $ (1.12) $ (0.65)
Weighted average per common
share -
basic and diluted 32,557 24,450 31,451 24,074
*T