72444--3/10/2010--NABI__BIOPHARMACEUTICALS

related topics

{product, candidate, development}

{product, liability, claim}

{personnel, key, retain}

{property, intellectual, protect}

{customer, product, revenue}

{tax, income, asset}

{product, market, service}

{financial, litigation, operation}

Our remaining product candidate is in clinical trials and the results from these trials may not be favorable. GSK may not exercise the NicVAX option which would have a material adverse effect on our future business, financial condition and results of operations. GSK may not be successful in developing and commercializing the future generation candidate vaccine. We do not have sufficient resources to fully develop, commercialize and market NicVAX and will require a successful partnership with GSK, another partner or additional financing to do so. Our inability to successfully manage the activities under our PentaStaph transition services agreement with GSK could have an adverse effect on our financial condition and results of operations. To be successful, we must attract, retain and motivate key employees, and the inability to do so could seriously harm our operations. We may not collect any further milestone or royalty payments under the PhosLo Agreement. We depend upon third parties to manufacture NicVAX. Our patents and proprietary rights may not provide sufficient protection, and patents of other companies could prevent us from developing and marketing NicVAX. We compete with larger, better-financed and more mature pharmaceutical and biotechnology companies that are capable of developing and marketing products more effectively than we are able to do. The market may not be receptive to NicVAX or any future generation candidate nicotine vaccines upon their introduction. The failure to comply with extensive regulations enforced by the FDA and foreign regulatory agencies could prevent or delay the sale of NicVAX or any future generation candidate nicotine vaccine We may be subject to costly and damaging product liability and other claims in connection with the development and commercialization of NicVAX We may not be able to maintain sufficient insurance, including products liability and directors and officers insurance, to cover claims against us. There are potential limitations on third-party reimbursement, complex regulations for reimbursement of products and other pricing-related matters that could adversely affect our ability to successfully commercialize, and impair our ability to generate sufficient revenues from, NicVAX and any future generation candidate vaccine. Our ability to use our federal and state net operating loss carry forwards to reduce taxable income generated in the future could be substantially limited.

Full 10-K form ▸