Exhibit 99.1
CONTACT:
Tierney Saccavino
Acorda Therapeutics
(914) 347-4300 ext. 104
tsaccavino@acorda.com
Jeff Macdonald
Acorda Therapeutics
(914) 347-4300 ext. 232
jmacdonald@acorda.com
FOR IMMEDIATE RELEASE
Acorda Therapeutics Reports Third Quarter 2008 Financial Results
HAWTHORNE, N.Y., November 4, 2008 – Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced its financial results for the third quarter of 2008.
“We made significant progress this quarter in preparing a New Drug Application for Fampridine-SR, which we expect to submit electronically to the U.S. Food and Drug Administration in the first quarter of 2009. We also concluded a series of meetings with four European regulatory agencies, and as a result are planning to file a Marketing Authorization Application for Fampridine-SR in Europe in 2009,” said Ron Cohen, M.D., Acorda Therapeutics’ President and CEO. “In addition, we completed a $127 million net equity financing in August, finishing the third quarter in a strong financial position with a cash balance of over $260 million.”
Financial Results and Product Update
Zanaflex Capsules® (tizanidine hydrochloride) and Zanaflex® (tizanidine hydrochloride) Tablets Gross Sales - For the quarter ended September 30, 2008, the Company reported combined gross sales of Zanaflex Capsules and Zanaflex tablets of $13.7 million, compared to combined gross sales of $11.5 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 Zanaflex tablets are reported.
Zanaflex Capsules and Zanaflex Tablets Shipments - Total Zanaflex Capsules and Zanaflex tablet shipments for the quarter ended September 30, 2008 were $15.7 million, compared to total shipments of $13.2 million for the same quarter in 2007.
Research and development expenses for the quarter ended September 30, 2008 were $8.7 million, including $0.6 million of share-based compensation, compared to $5.6 million including $0.3 million of share-based compensation for the same quarter in 2007. Research and development expense increases for the quarter ended September 30, 2008 included costs related to our Fampridine-SR long-term extension studies, preparation for a New Drug Application (NDA) filing for Fampridine-SR and development of two of our preclinical pipeline products for potential Investigational New Drug (IND) filings in late 2009.
Sales, general and administrative expenses for the quarter ended September 30, 2008 were $20.3 million, including $2.1 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 was 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 September 30, 2008 was $0.9 million compared to $1.0 million for the same quarter in 2007.
The Company reported a net loss of $18.9 million for the quarter ended September 30, 2008, or $0.53 per diluted common share, compared to a net loss of $8.5 million, or $0.30 per diluted common share, for the same quarter in 2007.
As of September 30, 2008, Acorda held cash, cash equivalents and short-term investments of $263.2 million, compared to $105.1 million on September 30, 2007, which are expected to be sufficient to fund the Company’s operations through 2010.
Fampridine-SR Scientific Update
On September 20, additional data from our second Phase 3 clinical trial of Fampridine-SR (MS-F204) on walking ability in people with multiple sclerosis (MS) was presented at the late breaking news session of the World Congress on Treatment and Research in Multiple Sclerosis. The key findings highlighted in the poster included:
· The response rate for Fampridine-SR treated patients was higher than placebo across all MS subtypes. Response rates for the four major MS subtypes in the study were: relapsing-remitting, 37.2%; secondary-progressive, 45.9%; primary-progressive, 50.0%; and progressive-remitting, 40.0%.
· Response rates were similar between study participants who were being treated with immunomodulators and those who were not.
Data from the Phase 2 Fampridine-SR multiple sclerosis trial (MS-F202) was published in the October edition of Neurology, the peer-reviewed journal of the American Academy of Neurology.
Fampridine-SR Regulatory Update
Acorda has completed scientific advice meetings with four European national regulatory agencies to discuss the development program completed for Fampridine-SR. As a result of these meetings, the Company plans to submit a Marketing Authorization Application (MAA) with the European Medicines Agency (EMEA) in 2009, under the centralized procedure, after the NDA is filed in the U.S. The Company is evaluating options to maximize the value of the product outside the U.S., including meeting with potential marketing and distribution partners.
Acorda is on track to file the NDA in the U.S. in the first quarter of 2009. The Company may also request Priority Review of the NDA.
Corporate Update
The Company completed a successful public offering of 4.6 million shares of its common stock in August 2008, raising net proceeds of approximately $127 million. This will be used to conduct activities related to the filing of an NDA and an MAA for Fampridine-SR, for pre-launch activities associated with the commercialization of Fampridine-SR, if approved, for research and development, including in connection with preclinical studies related to our neuregulin, remyelinating antibodies and chrondroitinase programs, and for general corporate purposes, including the funding of working capital and capital expenditures.
Acorda also announced its preclinical pipeline was selected by Windhover Information, a leader in providing analysis of the healthcare industry, as one of the top 10 most interesting neuroscience projects in development available for strategic partnering. Acorda plans to file IND applications in late 2009 for two preclinical compounds, a remyelinating monoclonal antibody (rhIgM22) and a
2
neuregulin protein with potential neurological and cardiac applications (GGF2), pending results of toxicology studies.
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 third quarter 2008 results.
To participate in the conference call, please dial 866-713-8310 (domestic) or 617-597-5308 (international) and reference the access code 13930885. The presentation will be available via a live webcast at http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetails&c=194451&eventID=2000115
A replay of the call will be available from 10:30 a.m. ET on November 4, 2008 until midnight on December 3, 2008. To access the replay, please dial 888-286-8010 (domestic) or 617-801-6888 (international) and reference the access code 98421748. 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. In June 2008, Fampridine-SR 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® (tizanidine hydrochloride), a short-acting drug for the management of spasticity. Acorda has completed two Phase 3 clinical trials to evaluate the safety and efficacy of Fampridine-SR 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.
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Financial Statements
Acorda Therapeutics, Inc
Condensed Consolidated Balance Sheet Data
(in thousands)
(Unaudited)
| | September 30, | | December 31, | |
| | 2008 | | 2007 | |
| | | | | |
Assets | | | | | |
Cash, cash equivalents and short-term investments | | $ | 263,245 | | $ | 95,121 | |
Trade receivable, net | | 4,016 | | 4,265 | |
Other current assets | | 3,695 | | 3,923 | |
Finished goods inventory | | 7,454 | | 7,724 | |
Property and equipment, net | | 1,869 | | 1,652 | |
Intangible assets, net | | 17,155 | | 13,944 | |
Other assets | | 545 | | 677 | |
Total assets | | $ | 297,979 | | $ | 127,306 | |
| | | | | |
Liabilities and stockholders’ equity | | | | | |
Accounts payable, accrued expenses and other liabilities | | $ | 23,752 | | $ | 15,453 | |
Deferred product revenue | | 23,375 | | 21,837 | |
Current liabilities | | 1,338 | | 1,973 | |
Long term notes payable | | 6,854 | | 6,703 | |
Non-current portion of revenue interest liability | | 18,315 | | 17,907 | |
Stockholders’ equity | | 224,345 | | 63,433 | |
Total liabilities and stockholders’ equity | | $ | 297,979 | | $ | 127,306 | |
Acorda Therapeutics, Inc
Consolidated Statements of Operations
(in thousands, except per share amounts)
(Unaudited)
| | Three Months Ended | | Nine Months Ended | |
| | September 30, | | September 30, | |
| | 2008 | | 2007 | | 2008 | | 2007 | |
| | | | | | | | | |
Gross sales - Zanaflex | | $ | 13,667 | | $ | 11,507 | | $ | 39,442 | | $ | 30,810 | |
Less: discounts and allowances | | (1,224 | ) | (1,068 | ) | (4,153 | ) | (2,576 | ) |
Net sales | | 12,443 | | 10,439 | | 35,289 | | 28,234 | |
Grant revenue | | 23 | | 20 | | 76 | | 36 | |
Total net revenue | | 12,466 | | 10,459 | | 35,365 | | 28,270 | |
Cost of sales | | (2,701 | ) | (2,182 | ) | (8,517 | ) | (5,746 | ) |
Gross profit | | 9,765 | | 8,278 | | 26,848 | | 22,524 | |
| | | | | | | | | |
Operating expenses: | | | | | | | | | |
Research and development | | 8,651 | | 5,603 | | 25,758 | | 12,854 | |
Sales and marketing | | 14,420 | | 7,918 | | 36,349 | | 22,006 | |
General and administrative | | 5,948 | | 3,720 | | 17,392 | | 12,550 | |
Total operating expenses | | 29,019 | | 17,241 | | 79,499 | | 47,410 | |
| | | | | | | | | |
Operating loss | | $ | (19,254 | ) | $ | (8,963 | ) | $ | (52,651 | ) | $ | (24,886 | ) |
| | | | | | | | | |
Other income (expense), net | | 398 | | 431 | | (1,458 | ) | 641 | |
Net loss | | $ | (18,856 | ) | $ | (8,532 | ) | $ | (54,109 | ) | $ | (24,245 | ) |
| | | | | | | | | |
Net loss per common share - basic and diluted | | $ | (0.53 | ) | $ | (0.30 | ) | $ | (1.65 | ) | $ | (0.95 | ) |
| | | | | | | | | |
Weighted average per common share - basic and diluted | | 35,265 | | 28,209 | | 32,724 | | 25,468 | |
| | | | | | | | | | | | | | |
