722104--3/28/2006--SAVIENT_PHARMACEUTICALS_INC

related topics
{product, candidate, development}
{property, intellectual, protect}
{customer, product, revenue}
{financial, litigation, operation}
{stock, price, operating}
{control, financial, internal}
{cost, regulation, environmental}
{acquisition, growth, future}
{product, liability, claim}
{provision, law, control}
{personnel, key, retain}
{product, market, service}
{operation, international, foreign}
{stock, price, share}
Risks Related to our Restatement The restatement of our consolidated financial statements had, and could continue to have, a material adverse impact on us, including increased costs, the possibility of legal or administrative proceedings and delisting warnings from The NASDAQ National Market. We have identified material weaknesses in our internal controls over financial reporting, some of which have not been fully remediated. In addition, we may experience additional material weaknesses in the future. Any material weaknesses in our internal control over financial reporting or our failure to remediate such material weaknesses could result in a material misstatement in our financial statements not being prevented or detected and could adversely affect investor confidence in the accuracy and completeness of our financial statements, as well as our stock price. Risks Relating to Our New Strategic Direction We are repositioning our company to focus on product development, including an enhanced focus on the clinical development of Puricase (PEG-uricase), our lead product candidate currently entering Phase 3 clinical trials. If we are unable to commercialize this product candidate or any other product candidate that we may pursue in the future, or if we experience significant delays or unanticipated costs in doing so, our business will be materially harmed. Puricase (PEG-uricase), and any other product candidate that we may develop in the future, must satisfy rigorous standards of safety and efficacy before they can be approved for sale. To satisfy these standards, we must engage in expensive and lengthy clinical trials and extensive manufacturing quality assessments to obtain regulatory approval. Our new strategic focus includes a licensing program to partner our Puricase (PEG-uricase) product outside the United States and to in-license other novel compounds to build our development portfolio. We may not be successful in our licensing efforts and in expanding our portfolio of products in this manner. Risks Related to Our Business We incurred an operating loss in 2005 and anticipate that we may incur net losses for the foreseeable future. If we are unable to commercialize Puricase (PEG-uricase) or any other product candidates, we may never return to profitability. We will need substantial capital to develop and commercialize products, and we may be unable to obtain additional capital. If we are unable to obtain additional financing, our business, results of operations and financial condition may be adversely affected. A significant portion of our revenues is attributable to sales of Oxandrin. Sales of Oxandrin declined during 2005 as compared to 2004 and 2003. Oxandrin may begin facing generic competition at any time, which would likely cause a significant further decrease in Oxandrin sales and render our existing Oxandrin inventory obsolete. Oxandrin sales in particular reporting periods may be affected by wholesalers buying patterns and product returns. Our results of operations have been adversely affected by returns of Oxandrin. Future returns of Oxandrin or other products could also affect our results of operations. We operate in a highly competitive market. Our competitors may develop alternative technologies or safer or more effective products before we are able to do so. Manufacturing our products and those of Rosemont s requires us and Rosemont to meet stringent quality control standards. In addition, we depend on third parties to manufacture our products and plan to rely on third parties to manufacture any future products. If we or these third parties fail to meet applicable quality requirements, our revenues and product development efforts may be materially adversely affected. The manufacture and packaging of pharmaceutical products are subject to the requirements of the FDA and similar foreign regulatory bodies. If we or our third party suppliers fail to satisfy these requirements, our business operations may be materially harmed. We may not be successful in establishing additional strategic alliances, which could adversely affect our ability to develop and commercialize products and services. Our sales depend on payment and reimbursement from third party payors and a reduction in the payment or reimbursement rate could result in decreased use or sales of our products. We have recently made significant changes in our senior management team. If we fail to attract and keep senior management and key scientific personnel, we may be unable to successfully develop or commercialize our product candidates. Economic, political, pricing regulation in foreign jurisdictions and other risks associated with foreign operations could adversely affect our international sales. We may incur substantial costs related to product liability. The ultimate outcome of pending securities litigation is uncertain. Risks Relating to Intellectual Property If we are unable to obtain and maintain protection for the intellectual property relating to our technology and products, the value of our technology and products will be adversely affected. If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could be adversely affected. If we infringe or are alleged to infringe intellectual property rights of third parties, it will adversely affect our business. In the future we may be involved in costly legal proceedings to enforce or protect our intellectual property rights or to defend against claims that we infringe the intellectual property rights of others. We are subject to stringent governmental regulation, and our failure to comply with applicable regulations could adversely affect our ability to conduct our business. Risks Relating to an Investment in Our Common Stock Our stock price is volatile, which could adversely affect your investment. We expect our quarterly results to fluctuate, which may cause volatility in our stock price. Effecting a change of control of our company could be difficult, which may discourage offers for shares of our common stock.

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