Acorda Therapeutics Reports First Quarter 2006 Financial Results.HAWTHORNE, N.Y. -- Acorda Therapeutics therapeutics Treatment and care to combat disease or alleviate pain or injury. Its tools include drugs, surgery, radiation therapy, mechanical devices, diet, and psychiatry. (R) (Nasdaq: ACOR ACOR Association of Cancer Online Resources ACOR American Center of Oriental Research ACOR Advanced Certificate in Operational Risk ACOR Assistant Contracting Officer Representative ACOR Actual Cost of Repair ACOR Administrative Contracting Officers Representative ) today announced its financial results for the quarter ended March 31, 2006. Financial Results For the quarter ended March 31, 2006, gross sales Gross Sales A measure of overall sales that isn't adjusted for customer discounts or returns, calculated simply by adding all sales invoices, and not including operating expenses, cost of goods sold, payment of taxes, or any other charge. of Zanaflex Capsules(TM) (tizanidine hydrochloride tizanidine hydrochloride Zanaflex Pharmacologic class: Alpha-adrenergic agonist (centrally acting) Therapeutic class: Skeletal muscle relaxant Pregnancy risk category C Action) were $2.3 million and gross sales of Zanaflex(R) tablets were $1.6 million providing combined gross sales of $3.9 million, compared to $0 for the same quarter in 2005. 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 or gross sales when end-user prescriptions of Zanaflex Capsules and tablets are reported. Zanaflex Capsule capsuleIn botany, a dry fruit that opens when ripe. It splits from top to bottom into separate segments known as valves, as in the iris, or forms pores at the top (e.g., poppy), or splits around the circumference, with the top falling off (e.g., pigweed and plantain). shipments to wholesalers for the quarter ended March 31, 2006 were $2.5 million and Zanaflex tablet See digitizer tablet and tablet computer. TABLET - A query language. ["Human Factor Comparison of a Procedural and a Non-procedural Query Language", C. Welty et al, ACM Trans Database Sys 6(4):626-649 (Dec 1981)]. shipments were $1.3 million providing total shipments of $3.8 million, compared to $3.2 million in Zanaflex tablet shipments for the same quarter in 2005. Net loss for the quarter ended March 31, 2006 was $44.1 million or $4.05 per share, compared to a net loss of $13.4 million or $67.65 per share for the same quarter in 2005. The net loss in the quarter ended March 31, 2006 included $37.2 million in non-cash charges Non-Cash Charge A charge off, made by a company against earnings, that does not require an initial outlay of cash. Notes: Non-cash charges are typically against the depreciation, amortization, and depletion accounts on a company's balance sheet. associated with the remaining unamortized portion of beneficial conversion charges and issuance costs and reversal of accrued ac·crue v. ac·crued, ac·cru·ing, ac·crues v.intr. 1. To come to one as a gain, addition, or increment: interest accruing in my savings account. 2. preferred dividends preferred dividend n. a payment of a corporation's profits to holders of preferred shares of stock. (See: preferred stock) recorded as a result of our initial public offering. As of March 31, 2006, the Company held cash, cash equivalents and short-term investments of $30.0 million. "We're pleased with the substantial growth in sales during the first quarter, during which we expanded the sales force and strengthened the Company's commercial infrastructure," stated Ron Cohen cohen or kohen (Hebrew: “priest”) Jewish priest descended from Zadok (a descendant of Aaron), priest at the First Temple of Jerusalem. The biblical priesthood was hereditary and male. , M.D., President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "We also announced the completion of enrollment for our Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. of Fampridine-SR in multiple sclerosis multiple sclerosis (MS), chronic, slowly progressive autoimmune disease in which the body's immune system attacks the protective myelin sheaths that surround the nerve cells of the brain and spinal cord (a process called demyelination), resulting in damaged areas and had encouraging results from an additional analysis of leg strength data from the previous Phase 2 study." Zanaflex Capsules Highlights --In March 2006, Acorda initiated a primary care pilot program with Innovex, using six part-time representatives making exclusive calls for Zanaflex Capsules. These sales representatives have now been trained and are currently calling on high prescribing primary care physicians. Fampridine-SR Highlights --On March 3, 2006 Acorda announced the completion of enrollment of its Phase 3 clinical trial of Fampridine-SR in multiple sclerosis (MS). The study, which is based on a Special Protocol Assessment (SPA) from the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ), is evaluating the safety and efficacy of Fampridine-SR in improving walking ability in people with MS. Based on enrollment, the trial is powered at greater than 90% for the demonstration of efficacy. --On April 17, 2006 Acorda disclosed a new evaluation of leg strength data from the 2004 MS-F202 Phase 2 clinical study of Fampridine-SR. The Fampridine-SR Timed-Walk responder group and the non-responder group both showed significant improvement in leg strength compared to the placebo group (p less than 0.001 for each group). These data suggest that Fampridine-SR may also have benefits for patients who do not experience a consistent improvement in walking speed with treatment. Conference Call and Webcast Ron Cohen, President and Chief Executive Officer, David Lawrence David Lawrence can refer to many people:
The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. will host a conference call today at 8:30 am Eastern Time to review the Company's first quarter 2006 results. To access the call, please dial 800-599-9795 (domestic) or 617-786-2905 (international) five minutes prior to the start time, and provide the access code 58128848. A replay of the call will be available from 10:30 a.m. Eastern Time on May 5, 2006 until 11:59 p.m. Eastern Time on June 5, 2006. To access the replay, please dial 888-286-8010 (domestic) or 617-801-6888 (international), and provide the access code 73965243. A live audio webcast of the call can also be accessed from the Company's website, at http://www.acorda.com, for the next 30 days. Forward Looking Statements This press release includes forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 Acorda Therapeutics' ability to successfully market and sell Zanaflex Capsules , the risk of unfavorable results from the Phase 3 clinical trial of Fampridine SR, delays in obtaining or failure to obtain FDA approval of Fampridine-SR, competition, the ability to obtain additional financing to support Acorda Therapeutics' operations, unfavorable results from its preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. programs, and failure to protect its intellectual property or to defend against the intellectual property claims of others. 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. About Acorda Therapeutics Acorda Therapeutics is a biotechnology company developing therapies for SCI (Scalable Coherent Interface) An IEEE standard for a high-speed bus that uses wire or fiber-optic cable. It can transfer data up to 1GBytes/sec. (hardware) SCI - 1. Scalable Coherent Interface. 2. UART. , MS and related nervous system disorders Nervous system disorders A satisfactory classification of diseases of the nervous system should include not only the type of reaction (congenital malformation, infection, trauma, neoplasm, vascular diseases, and degenerative, metabolic, toxic, or deficiency . The Company's marketed products include Zanaflex Capsules(TM) (tizanidine hydrochloride), a short-acting drug indicated for the management of spasticity spasticity /spas·tic·i·ty/ (spas-tis´i-te) the state of being spastic; see spastic (2). spas·tic·i·ty n. 1. A spastic state or condition. 2. Spastic paralysis. . For full prescribing information, please go to www.zanaflexcapsules.com. Acorda's lead clinical-stage product is Fampridine-SR, which is in a Phase 3 clinical trial for MS. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord spinal cord, the part of the nervous system occupying the hollow interior (vertebral canal) of the series of vertebrae that form the spinal column, technically known as the vertebral column. and brain.
Acorda Therapeutics, Inc
Consolidated Statements of Operations
(in thousands, except per share amounts)
(Unaudited)
Three Months Ended
March 31,
2006 2005
----------- -----------
Gross sales - Zanaflex $ 3,874 $ -
Less: discounts and allowances (196) (140)
----------- -----------
Net sales 3,678 (140)
Grant revenue 122 25
----------- -----------
Total net revenue 3,800 (115)
Less: cost of sales (1,041) (481)
----------- -----------
Gross profit 2,759 (596)
Operating expenses:
Research and development 3,277 2,103
Sales and marketing 4,562 2,302
General and administrative 2,278 2,112
----------- -----------
Total operating expenses 10,117 6,517
----------- -----------
Operating loss (7,358) (7,113)
----------- -----------
Other income (expense):
Interest and amortization of debt discount
expense (304) (149)
Interest income 262 110
Other income 2 -
----------- -----------
(40) (39)
Cumulative effect of change in accounting
principle 454 -
----------- -----------
Net loss (6,944) (7,152)
Beneficial conversion feature, accretion of
issuance costs, preferred dividends, and
fair value of warrants issued to
convertible preferred stockholders (37,168) (6,212)
----------- -----------
Net profit (loss) allocable to common
shareholders $ (44,112) $ (13,364)
=========== ===========
Net loss per share allocable to common
stockholders - basic and diluted $ (4.05) $ (67.65)
Weighted average common shares outstanding
used in computing net loss per share
allocable to common stockholders -
basic and diluted 10,879 198
Acorda Therapeutics, Inc
Consolidated Balance Sheet Data
(in thousands)
(Unaudited)
March 31, Dec. 31,
2006 2005
------ ------
Assets
Cash and cash equivalents $ 25,961 $ 11,761
Short-term investments 3,990 2,001
Finished goods inventory held by the Company 5,208 5,587
Property and equipment, net 1,577 1,707
Intangible assets, net 5,768 5,952
Total assets $ 49,553 $ 33,912
Liabilities and stockholders' equity (deficit)
Accounts payable, accrued expenses and other
liabilities $ 4,808 $ 14,060
Deferred product revenue 16,516 16,736
Total current liabilities 26,554 35,858
Long term liabilities 23,282 23,377
Stockholders deficit (283) (116,536)
Total Liabilities and Stockholders deficit $ 49,553 $ 33,912
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