831547--4/5/2010--SPECTRUM_PHARMACEUTICALS

related topics

{product, candidate, development}

{product, liability, claim}

{property, intellectual, protect}

{product, market, service}

{control, financial, internal}

{stock, price, share}

{financial, litigation, operation}

{regulation, government, change}

{stock, price, operating}

{provision, law, control}

{gas, price, oil}

{cost, regulation, environmental}

{personnel, key, retain}

{cost, operation, labor}

{debt, indebtedness, cash}

{acquisition, growth, future}

{loss, insurance, financial}

{operation, international, foreign}

Clinical trials may fail to demonstrate the safety and efficacy of our drug products, which could prevent or significantly delay obtaining regulatory approval. If we are unable to effectively maintain and expand our sales and marketing capabilities, we may be unable to successfully commercialize our approved products. If we are unable to maintain or obtain improved reimbursement rates for Zevalin, the product s operating results may be harmed, which could adversely affect our financial and operating results. We may face difficulties in achieving broader market acceptance of Zevalin if we do not invest significantly in our sales and marketing infrastructure. We are aware of several competitors attempting to develop and market products competitive to Zevalin, which may reduce or eliminate our commercial opportunity. The intellectual property and assets owned by our subsidiary, RIT, are subject to a security agreement with Biogen that secures the entity s payment and other obligations to Biogen, and we have guaranteed all of those obligations. If we are unable to expand the approved usage of Fusilev, the product s operating results may be harmed, which could adversely affect our financial and operating results. Our drug product Fusilev may not be more cost-effective than competing drugs and otherwise may not have any competitive advantage, which could hinder our ability to successfully commercialize it. The marketing and sale of Fusilev and Zevalin may be adversely affected by the marketing and sales efforts of third parties who sell these products outside the United States. The development of our drug product, apaziquone, may be adversely affected if the development efforts of Allergan, who retained certain rights to the product, are not successful. The development of our drug product, belinostat, may be adversely affected if the development efforts of TopoTarget, who retained certain rights to the product, are not successful. The development of our drug product, ozarelix, may be adversely affected if the development efforts of Aeterna Zentaris, who retained certain rights to the product, are not successful. The development of our drug product, satraplatin, depends on the efforts of a third party and, therefore, its eventual success or commercial viability is largely beyond our control. Our dependence on key executives, scientists and sales and marketing personnel could impact the development and management of our business. As we evolve from a company primarily involved in development to a company also involved in commercialization, we may encounter difficulties in managing our growth and expanding our operations successfully. If we acquire additional businesses, we may not successfully integrate their operations. Our collaborations with outside scientists may be subject to change, which could limit our access to their expertise. We may rely on contract research organizations and other third parties to conduct clinical trials and, in such cases, we are unable to directly control the timing, conduct and expense of our clinical trials. We are subject to risks associated with doing business internationally. We may have conflicts with our partners that could delay or prevent the development or commercialization of our drug products. Our efforts to acquire or in-license and develop additional drug products may fail, which might limit our ability to grow our business. From time to time we may need to license patents, intellectual property and proprietary technologies from third parties, which may be difficult or expensive to obtain. We are a small company relative to our principal competitors, and our limited financial resources may limit our ability to develop and market our drug products. Our supply of drug products will be dependent upon the production capabilities of contract manufacturing organizations (CMOs) and component and packaging supply sources, and, if such CMOs are not able to meet our demands, we may be limited in our ability to meet demand for our products, ensure regulatory compliance or maximize profit on the sale of our products. We may not be successful in establishing additional active pharmaceutical ingredient or finished dose drug supply relationships, which would limit our ability to develop and market our drug products. Our drug products may not be more effective, safer or more cost-efficient than a competing drug and otherwise may not have any competitive advantage, which could hinder our ability to successfully commercialize our drug products. The size of the market for our potential products is uncertain. If actual future payments for allowances, discounts, returns, rebates and chargebacks exceed the estimates we made at the time of the sale of our products, our financial position, results of operations and cash flows may be materially and negatively impacted. Risks Related to Our Industry If third-party payors do not adequately reimburse providers for any of our products, if approved for marketing, we may not be successful in selling them. Wholesaler actions could increase competitive and pricing pressures on pharmaceutical manufacturers, including us. Rapid bio-technological advancement may render our drug products obsolete before we are able to recover expenses incurred in connection with their development. As a result, our drug products may never become profitable. Competition for patients in conducting clinical trials may prevent or delay product development and strain our limited financial resources. Failure to obtain regulatory approval outside the United States will prevent us from marketing our product candidates abroad. Even after we receive regulatory approval to market our drug products, the market may not be receptive to our drug products upon their commercial introduction, which would negatively impact our ability to achieve profitability. Guidelines and recommendations published by various organizations can reduce the use of our products. Our failure to comply with governmental regulations may delay or prevent approval of our drug products and/or subject us to penalties. The discovery of previously unknown safety risks with drug products approved to go to market may raise costs or prevent us from marketing such products or change the labeling of our products or take other potentially limiting or costly actions if we or others identify safety risks after our products are on the market. Our failure to comply with FDA (and related) regulations applicable to our business may subject us to sanctions, which could damage our reputation and adversely affect our business condition. Legislative or regulatory reform of the healthcare system and pharmaceutical industry related to pricing or reimbursement may hurt our ability to sell our products profitably or at all. If we market products in a manner that violates health care anti-kickback or other anti-fraud and anti-abuse laws, we may be subject to civil or criminal penalties, including exclusions from participation in Federal health care programs. If we are unable to adequately protect our technology or enforce our patent rights, our business could suffer. Intellectual property rights are complex and uncertain and therefore may subject us to infringement claims. Intellectual property litigation is increasingly common and increasingly expensive and may result in restrictions on our business and substantial costs, even if we prevail. We may be subject to damages resulting from claims that we, or our employees, have wrongfully used or disclosed alleged trade secrets of our employees former employers. We may be subject to product liability claims, and may not have sufficient product liability insurance to cover any such claims, which may expose us to substantial liabilities. The use of hazardous materials, including radioactive and biological materials, in our research and development and commercial efforts imposes certain compliance costs on us and may subject us to liability for claims arising from the use or misuse of these materials. Risks Related to Our Common Stock There are a substantial number of shares of our common stock eligible for future sale in the public market. The sale of these shares could cause the market price of our common stock to fall. Any future equity issuances by us may have dilutive and other effects on our existing stockholders. The market price and trading volume of our common stock fluctuate significantly and could result in substantial losses for individual investors. Provisions of our charter, bylaws and stockholder rights plan may make it more difficult for someone to acquire control of us or replace current management even if doing so would benefit our stockholders, which may lower the price an acquirer or investor would pay for our stock. The restatement of our historical financial statements has already consumed, and may continue to consume, a significant amount of our time and resources and may have a material adverse effect on our business and stock price. If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results, and current and potential stockholders may lose confidence in our financial reporting. Our publicly-filed SEC reports are reviewed by the SEC from time to time and any significant changes required as a result of any such review may result in material liability to us and have a material adverse impact on the trading price of our common stock. We were unable to timely file this Annual Report on Form 10-K as required by the Securities Exchange Act of 1934. Our continued inability to file these reports on time could result in investors not having access to important information about us and the delisting of our common stock from NASDAQ.

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831547--4/5/2010--SPECTRUM_PHARMACEUTICALS_INC