722104--3/16/2007--SAVIENT_PHARMACEUTICALS_INC

related topics
{product, candidate, development}
{property, intellectual, protect}
{stock, price, operating}
{control, financial, internal}
{cost, regulation, environmental}
{product, liability, claim}
{financial, litigation, operation}
{provision, law, control}
{customer, product, revenue}
{personnel, key, retain}
{product, market, service}
{regulation, change, law}
{acquisition, growth, future}
{stock, price, share}
Puricase, and any other product candidate that we may develop in the future, must satisfy rigorous standards of safety and efficacy before it 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. We rely on third parties to conduct our clinical trials of Puricase and those third parties may not perform satisfactorily, including failing to meet established deadlines for the completion of such trials. Our strategic focus includes a licensing initiative to partner our Puricase product candidate outside the United States. We may not be successful in our efforts to partner our Puricase product candidate. Our strategic focus includes an initiative to in-license or partner other novel compounds to build our development portfolio. We may not be successful in our efforts to expand our portfolio of products in this manner. The full development and commercialization of our development drug products and execution of our strategic business plan will require substantial capital, and we may be unable to obtain such capital. If we are unable to obtain additional financing, our business, results of operations and financial condition may be adversely affected. Risks Related to Our Business We incurred an operating loss from continuing operations for the year ended 2006 and anticipate that we may incur operating losses from continuing operations for the foreseeable future. If we are unable to commercialize Puricase or any other product candidates, we may never achieve operating profitability. A significant portion of our revenues was attributable to sales of Oxandrin in 2006. The 2006 launch of generic competition to Oxandrin will likely cause a significant decrease in Oxandrin sales in 2007 and future years and may render our existing Oxandrin inventory obsolete. In addition, Oxandrin sales in particular reporting periods may be affected by wholesalers buying patterns and product returns. Future returns of Oxandrin, our authorized generic of Oxandrin or other products could also affect our results of operations. If third parties on which we rely for distribution of our generic version of oxandrolone do not perform as contractually required or as we expect, our results of operations may be harmed. 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 requires us 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 these third party suppliers, and particularly our sole source supplier for Puricase, fail to supply us for any reason, 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 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. 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. We may incur substantial costs related to product liability. The ultimate outcome of pending securities litigation is uncertain. Tax requirements and audits could impact our results of operations. Risks Related to Previous Weaknesses in our Internal Controls Risks Relating to Intellectual Property If we fail to comply with our obligations in our intellectual property licenses with third parties, we could lose license rights that are important to our business. 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, our business may be adversely affected. 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.

Full 10-K form ▸

related documents
722104--3/14/2008--SAVIENT_PHARMACEUTICALS_INC
1000694--3/16/2007--NOVAVAX_INC
886744--3/16/2007--GERON_CORP
886744--2/28/2008--GERON_CORP
932903--3/17/2008--AVIGEN_INC_\DE
932903--3/16/2007--AVIGEN_INC_\DE
1162192--3/31/2009--AVALON_PHARMACEUTICALS_INC
932903--3/16/2009--AVIGEN_INC_\DE
1305409--3/20/2006--Valera_Pharmaceuticals_Inc
944522--3/23/2009--VION_PHARMACEUTICALS_INC
877902--3/8/2006--NEOSE_TECHNOLOGIES_INC
899923--8/26/2009--MYRIAD_GENETICS_INC
899923--8/12/2010--MYRIAD_GENETICS_INC
730272--6/9/2006--REPLIGEN_CORP
729922--3/1/2007--OSI_PHARMACEUTICALS_INC
1172480--3/6/2009--SANTARUS_INC
729922--2/24/2010--OSI_PHARMACEUTICALS_INC
891293--3/16/2006--CELL_THERAPEUTICS_INC
1172480--3/4/2010--SANTARUS_INC
1029142--3/16/2006--DYNAVAX_TECHNOLOGIES_CORP
1000694--3/31/2009--NOVAVAX_INC
1000694--3/17/2008--NOVAVAX_INC
927829--3/6/2008--NITROMED_INC
1029142--3/16/2007--DYNAVAX_TECHNOLOGIES_CORP
1288379--3/15/2006--NEW_RIVER_PHARMACEUTICALS_INC
1476170--9/28/2010--Unilife_Corp
1123979--2/4/2010--SENOMYX_INC
884731--3/14/2007--ARIAD_PHARMACEUTICALS_INC
882095--2/27/2007--GILEAD_SCIENCES_INC
786623--3/27/2008--ADVANCED_VIRAL_RESEARCH_CORP