Nov 2 2006, 5:30 AM EST
News source: Business Wire
Acorda Therapeutics (Nasdaq: ACOR) today announced its financial results for the third quarter ended September 30, 2006.
Financial Results
For the quarter ended September 30, 2006, gross sales of Zanaflex Capsules(TM) (tizanidine hydrochloride) were $5.0 million and gross sales of Zanaflex(R) tablets were $1.5 million providing combined gross sales of $6.5 million. For the same quarter in 2005 gross sales of Zanaflex Capsules were $0.9 million and gross sales of Zanaflex tablets were $1.9 million for total gross sales of $2.8 million. Gross sales are recognized using a deferred revenue recognition model, where Zanaflex product shipments to wholesalers are recorded as deferred revenue and only recognized as revenue or gross sales when end-user prescriptions of Zanaflex Capsules and tablets are reported. Shipments to wholesalers for the quarter ended September 30, 2006 of $8.7 million consisted of $6.9 million for Zanaflex Capsules and $1.8 million for Zanaflex tablets. For the same quarter in 2005, we recorded $2.5 million in shipments consisting of $0.4 million in Zanaflex Capsules and $2.1 million in Zanaflex tablets.
Net loss for the third quarter ended September 30, 2006 was $7.2 million or $.37 per share, compared to a net loss of $13.9 million or $66.62 per share for the same quarter in 2005.
As of September 30, 2006, the Company held cash, cash equivalents and short-term investments of $18.4 million. The Company believes that its current financial resources, including the net proceeds of $29.8 million from the recently completed October 2006 financing, should be sufficient to fund its operations and meet its financial obligations into the first quarter of 2008 based on the Company's current projected revenue and spending levels.
"I was pleased to report in September that the Company achieved positive results from its Phase 3 clinical trial of Fampridine-SR on walking ability in people with multiple sclerosis," stated Ron Cohen, M.D., President and CEO. "We believe that Fampridine-SR, if approved, could be a first-in-class product, as no existing therapies are indicated to improve walking or other function for people with MS. We also have had continued growth in our Zanaflex Capsules franchise, and recently announced the expansion of our commercial sales force from 32 to 65. This sales organization will provide the commercial foundation for the launch of Fampridine-SR, if approved."
Fampridine-SR Highlights
-- The Company reported positive data from the Phase 3 clinical trial of Fampridine-SR on September 25, 2006. Following are the top-line results from that trial:
-- Statistical significance was achieved on all three efficacy criteria defined in the Special Protocol Assessment (SPA) by the Food and Drug Administration (FDA). A significantly greater proportion of Fampridine-SR responders had a consistent improvement in walking speed, the study's primary outcome, compared to people taking placebo (34.8 percent vs. 8.3 percent) as measured by the Timed 25-Foot Walk (p less than 0.001). In addition, the effect was maintained in this study throughout the 14-week treatment period (p less than 0.001) and there was a statistically significant improvement in the 12-Item MS Walking Scale (MSWS-12) for walking responders vs. non-responders (p less than 0.001).
-- The average increase in walking speed over the treatment period for this Phase 3 study compared to baseline was 25.2 percent for the drug responder group vs. 4.7 percent for the placebo group.
-- Additionally, increased response rate on the Timed 25-Foot
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