HAWTHORNE, N.Y. — 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.”
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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 < 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). skelaxin. 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.