Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced its financial results for the third quarter of 2009.
“The positive vote from the FDA Advisory Committee was an important step toward making Fampridine-SR available to people with multiple sclerosis who may benefit from this novel therapy, if approved,” said Ron Cohen, M.D., Acorda Therapeutics’ President and CEO. “We look forward to continuing to work with the FDA as it completes its review of the Fampridine-SR submission.”
Financial Results and Product Update
Zanaflex Capsules® (tizanidine hydrochloride) and Zanaflex® (tizanidine hydrochloride) Tablets gross sales - For the quarter ended September 30, 2009, the Company reported combined gross sales of Zanaflex Capsules and Zanaflex tablets of $14.5 million, compared to combined gross sales of $13.7 million for the same quarter 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. There has been a slight downward trend in prescriptions over the first three quarters of 2009.
Zanaflex Capsules and Zanaflex Tablets shipments - Total Zanaflex Capsules and Zanaflex tablet shipments for the quarter ended September 30, 2009 were $15.3 million, compared to total shipments of $15.7 million for the same quarter in 2008.
License Revenue - For the quarter ended September 30, 2009, the Company reported license revenue of $2.4 million, a portion of the $110 million received from Biogen Idec for the collaboration agreement entered into on June 30, 2009. The balance of this payment will be recognized as revenue ratably over the remainder of the estimated term of the collaboration agreement. The Company currently estimates the revenue recognition period to be approximately 12 years.
Cost of License Revenue - For the quarter ended September 30, 2009, the Company recorded cost of license revenue of $0.2 million 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 12 year term of the collaboration agreement as the related revenue is recognized.
Research and development expenses for the quarter ended September 30, 2009 were $8.2 million, including $0.9 million of share-based compensation, compared to $8.7 million including $0.6 million of share-based compensation for the same quarter in 2008. The decrease in research and development expenses for the quarter ended September 30, 2009 was primarily due to a decrease in regulatory and clinical development program expenses relating to Fampridine-SR partially offset by increased expenses related to the development of the Company’s preclinical pipeline products.
Sales, general and administrative expenses for the quarter ended September 30, 2009 were $23.3 million, including $2.3 million of share-based compensation, compared to $20.4 million including $2.1 million of share-based compensation for the same quarter in 2008. This increase in expenses was primarily due to increases in Fampridine-SR pre-launch activities, medical affairs educational programs and SG&A staff and compensation. Sales, general and administrative expenses will continue to increase in 2009 compared to 2008, primarily due to an increase in the Company’s expected pre-launch costs.
The Company reported a net loss of $19.4 million for the quarter ended September 30, 2009, or $0.51 per diluted common share, compared to a net loss of $18.9 million, or $0.53 per diluted common share, for the same quarter in 2008.
As of September 30, 2009 Acorda held cash, cash equivalents, and short-term investments of $292.4 million. The Company expects this balance will provide a year-end 2009 cash, cash equivalents and short-term investment balance in excess of $250 million.
- On October 14, the Peripheral and Central Nervous System Drugs Advisory Committee appointed by the FDA voted 12 to 1 that clinical data on Fampridine-SR 10 mg twice daily demonstrated substantial evidence of effectiveness as a treatment to improve walking in people with multiple sclerosis (MS) and voted 10 to 2 (1 abstention) that it is clinically meaningful and can be safe for use.
- The Advisory Committee voted that lower doses of Fampridine-SR be studied as part of a post-marketing commitment. In addition, the Committee recommended against mandatory electroencephalography (EEG) screenings for prospective Fampridine-SR patients.
- On October 22, the FDA notified the Company that the October 22 Prescription Drug User Fee Act (PDUFA) goal date for the Fampridine-SR New Drug Application (NDA) was being extended to January 22, 2010. The Company had submitted additional information on its proposed Risk Evaluation and Mitigation Strategy (REMS) program following the Advisory Committee meeting and evolution of its commercial distribution plan, which the FDA accepted as a solicited major amendment.
- In September, data on safety, efficacy and retention rates from up to two years of participation in the Fampridine-SR extension studies were presented at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and the 13th Congress of the European Federation of Neurological Societies (EFNS).