Acorda Therapeutics Reports Fourth Quarter and Full Year 2006 Financial Results.HAWTHORNE, N.Y. -- Acorda Therapeutics, Inc. (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 fourth quarter and full year ended December 31, 2006. The Company also reviewed its recent highlights. "2006 was a transforming year for Acorda," commented 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., the company's President and Chief Executive Officer. "In September we announced positive Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. results for Fampridine-SR, showing a significant increase in walking ability in people with multiple sclerosis This is a list of people with multiple sclerosis, similar to the category "People with multiple sclerosis" but with sources and explanations. : Top - 0–9 A B C D E F G H I J K L M N O P Q R S T U V W X Y Z B
Fourth Quarter and Recent Highlights Fampridine-SR * The Company's MS-F203 Phase 3 data has been accepted for a platform presentation at the American Academy of Neurology The American Academy of Neurology (AAN) is a professional society for neurologists and neuroscientists. As a medical specialty society it was established in 1949 by A.B. Baker of the University of Minnesota to advance the art and science of neurology, and thereby promote the best (AAN AAN American Association of Neurology ) meeting on May 2, 2007 at 4:15 pm (ET). * On December 8, 2006, Acorda announced that, based on feedback from its meeting with the U.S. 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. ), it would design and conduct an additional Phase 3 trial of Fampridine-SR in people with MS. Acorda expects this study to be of shorter duration than its MS-F203 study with a single primary outcome, a consistent response on the Timed 25 Foot Walk. A protocol was submitted to the FDA for a Special Protocol Assessment (SPA). In response, the Agency has requested small amendments to the protocol that Acorda plans to implement. These do not involve significant changes to the overall design or the size of the trial. * As of February 15, 2007, over 1,300 people had been exposed to Fampridine-SR in clinical trials. This number includes more than 300 people treated for more than 6 months, approximately 150 people treated for more than one year and over 120 for greater than two years. Zanaflex Capsules * On Jan. 8, 2007, the Company announced it had completed the expansion of its sales force for Zanaflex Capsules to 65 people, 52 of whom are area business managers in field, calling on specialist and primary care physicians who are high-volume prescribers. This new sales force is expected to reach approximately 7,400 specialists and primary care physicians and will lay the foundation for the potential Fampridine-SR launch. Corporate * On February 7, 2007, the Company announced that it received a second $5 million payment as part of its amended agreement with an affiliate of Paul Capital Healthcare (formerly Paul Royalty Fund) to receive a total of $10 million to fund the expansion of its 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) sales force from 32 to 65 professionals and other Zanaflex Capsules operations. The second payment was made upon the achievement of specified sales goals for 2006.* The Company reported the addition of two new board members. Barry Greene, Chief Operating Officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. of Alnylam Pharmaceuticals Alnylam Pharmaceuticals Inc. (NYSE: ALNY), a biopharmaceutical company, engages in the development and commercialization of therapeutic products based on RNA interference (RNAi) in the United States. , joined the Board on January 9, 2007 and Ian Smith Noun 1. Ian Smith - Rhodesian statesman who declared independence of Zimbabwe from Great Britain (born in 1919) Ian Douglas Smith, Smith , Chief Financial Officer of Vertex Pharmaceuticals Vertex Pharmaceuticals is a biotechnology company with activities spanning the length of the pharmaceutical product pipeline, from target identification through to clinical trials and marketing. , Incorporated, joined the Board on February 1, 2007. * On December 1, 2006, Saints Capital converted its $2.5 million full-recourse convertible promissory note promissory note, unconditional written promise to pay a certain sum of money at a definite time to bearer or to a specified person on his order. Promissory notes are generally used as evidence of debt. into 210,863 shares of common stock. * On November 15, 2006, the Company announced that it had been selected for addition to the Nasdaq Biotechnology Index The NASDAQ Biotechnology Index includes securities of NASDAQ-listed companies classified according to the Industry Classification Benchmark as either Biotechnology or Pharmaceuticals which also meet other eligibility criteria. . * On October 4, 2006, Acorda announced the completion of a $31.5 million private placement of approximately 3.2 million shares of its common stock. Financial Results Zanaflex 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. - For the fourth quarter ended December 31, 2006, the Company reported gross sales of Zanaflex Capsules of $6.9 million and gross sales of Zanaflex([R]) tablets of $1.3 million providing combined gross sales of $8.2 million, compared to $2.7 million in combined gross sales for the same quarter in 2005. For the full year ended December 31, 2006, the Company reported gross sales of Zanaflex Capsules of $18.1 million and gross sales of Zanaflex tablets of $8.4 million providing combined gross sales of $26.5 million, compared to $5.9 million in combined gross sales for the same period 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 when end-user prescriptions of Zanaflex Capsules and tablets are reported. Zanaflex Shipments - Zanaflex Capsules shipments for the quarter ended December 31, 2006 were $10.6 million and Zanaflex tablet shipments were $2.0 million providing total shipments of $12.6 million compared to $1.7 million of Zanaflex Capsules shipments and $2.3 million of tablet shipments for total shipments of $4.0 million for the same quarter in 2005. For the year ended December 31, 2006, Zanaflex Capsules shipments were $24.2 million and Zanaflex tablets shipments were $6.7 million providing total shipments of $30.9 million compared to $7.8 million of Zanaflex Capsules shipments and $10.3 million of tablet shipments for total shipments of $18.1 million for the prior year. The Company reported net loss of $7.0 million for the quarter ended December 31, 2006, or $0.30 per share, compared to a net loss of $15.8 million, or $75.59 per share, for the same period in 2005. The Company reported a net loss of $60.0 million for the full year ended December 31, 2006, or $3.27 per share, compared to a net loss of $60.4 million, or $295.27 per share, in 2005. As of December 31, 2006, Acorda held cash, cash equivalents, and short-term investments of $53.8 million, compared to $13.8 million at December 31, 2005. Conference Call and Webcast Ron Cohen, President and Chief Executive Officer and David Lawrence, Chief Financial Officer will host a conference call today at 8:30 am ET to review the Company's fourth quarter and year end 2006 results. To access the call, please dial 866-356-3093 (domestic) or 617-597-5381 (international) and provide the access code 62235705 five minutes prior to the start time. A replay of the call will be available from 10:30 a.m. Eastern Time on February 20, 2007 until 11:59 p.m. Eastern Time on March 20, 2007. To access the replay, please dial 888-286-8010 (domestic) or 617-801-6888 (international), and provide the access code 70560177. 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 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 future studies 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 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 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, Fampridine-SR, recently completed a Phase 3 study 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 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. Financial Statements [TABLE OMITTED] [TABLE OMITTED] |
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