HAWTHORNE, N.Y. — Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced its financial results for the first quarter 2008.
“Acorda made impressive progress in all areas of our business in the first quarter of 2008. We reported favorable results of our Fampridine-SR Thorough QT study, continued to deliver solid Zanaflex Capsules sales performance, and entered into a manufacturing agreement for our preclinical neuregulins program. In addition, we were successful in raising approximately $75 million in additional capital to fund our programs,” said Ron Cohen, M.D., Acorda Therapeutics’ President and CEO. “As a result, we are well-positioned to address the important milestones ahead, particularly completion of our Phase 3 trial of Fampridine-SR which, if successful, will be followed by the filing of a new drug application, or NDA, in the first quarter of 2009. We are also executing on pre-launch activities and the preparation of our preclinical pipeline for two potential investigational new drug, or IND, filings in late 2009.”
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Financial Results and Product Update
Zanaflex([R]) (tizanidine hydrochloride) Gross Sales - For the quarter ended March 31, 2008, the Company reported gross sales of Zanaflex Capsules([R])(tizanidine hydrochloride) of $11.8 million and gross sales of Zanaflex tablets of $0.9 million, providing combined gross sales of $12.7 million, compared to gross sales of Zanaflex Capsules of $7.6 million and gross sales of Zanaflex tablets of $1.2 million providing combined gross sales of $8.8 million for the same quarter in 2007. Gross sales are recognized using a deferred revenue recognition model, meaning Zanaflex product 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 Shipments - Zanaflex Capsules shipments for the quarter ended March 31, 2008 were $13.6 million and Zanaflex tablet shipments were $1.2 million, providing total shipments of $14.8 million compared to $7.1 million of Zanaflex Capsules shipments and $0.8 million of tablet shipments for total shipments of $7.9 million for the same quarter in 2007.
“Zanaflex Capsules have played a vital role in allowing Acorda to transition into a fully-integrated pharmaceutical company. The commercial expertise we have developed from launching this product and growing the business has prepared us for the launch of Fampridine-SR, if approved,” said John Librie, Senior Vice President, Sales and Marketing. “We anticipate continued sales growth in 2008, although at a more moderate pace as the Zanaflex franchise matures. We also expect our Zanaflex commercial operations to produce a positive net cash flow this year.”
Research and development expenses for the quarter ended March 31, 2008 were $9.6 million, including a $2.7 million non-cash charge for the acquisition of certain assets from Neurorecovery, Inc. (NRI), and $0.4 million of share-based compensation, compared to $3.2 million, including $0.3 million of share-based compensation, for the same quarter in 2007. Other research and development expense increases for the quarter ended March 31, 2008 include clinical trial costs related to our Fampridine-SR Phase 3 trial, costs related to the preparation for a potential 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 March 31, 2008 were $15.3 million, including $1.5 million of share-based compensation, compared to $11.3 million including $1.9 million of share-based compensation for the same quarter in 2007. This increase in expenses is primarily due to increases in Zanaflex promotional activities and Fampridine-SR pre-launch activities. Sales, general and administrative expenses are expected to continue to increase in 2008 primarily due to an increase in our expected pre-launch.
The Company reported a net loss of $16.4 million for the quarter ended March 31, 2008, or $0.54 per diluted common share, compared to a net loss of $7.5 million, or $0.32 per diluted common share, for the same quarter in 2007.
The impact of the NRI acquisition discussed above and the differences between non-GAAP and GAAP net loss and net loss per diluted share are reconciled in the table below. The Company believes it is appropriate to present this supplemental information as it will allow investors to better understand the Company’s operating results for the first quarter of 2008 and its ongoing performance in a manner similar to how the Company analyzes its operating results. Adjustments and other factors make it more difficult to make meaningful period to period comparisons. These non-GAAP financial measures should not be construed as being more important than comparable GAAP measures.
Reconciliation of GAAP Net Loss to Adjusted Net Loss
The following table reconciles the Company’s net loss and net loss per diluted share as determined in accordance with U.S. generally accepted accounting principles (GAAP) to its adjusted net loss and net loss per diluted share for the three months ended March 31, 2008: