906709--3/1/2007--NEKTAR

related topics

{product, candidate, development}

{product, liability, claim}

{property, intellectual, protect}

{acquisition, growth, future}

{debt, indebtedness, cash}

{control, financial, internal}

{operation, natural, condition}

{provision, law, control}

{personnel, key, retain}

{financial, litigation, operation}

{stock, price, share}

Our revenue and results of operations depend on sales to Pfizer. The Exubera commercial launch is in the early stages and there can be no assurance regarding the commercial success of Exubera. If we are not able to manufacture and supply sufficient quantities of Exubera Inhalation Powder to meet market demand it would negatively impact our revenue and results of operations. We depend on two contract manufacturers to manufacture the Exubera Inhalers and the failure to manufacture sufficient quantities of the Exubera Inhalers to meet market demand would negatively impact our revenues and results of operations. If Pfizer is unable to manufacture and deliver bulk insulin for powder processing, fill the insulin powder into blister packs for the Exubera Inhaler, or package sufficient quantities of the Exubera product to meet market demand, it would significantly and negatively impact our revenues and results of operations. The discovery of any new or more severe side effects or negative efficacy findings for Exubera could significantly harm our business. If we are not successful in developing the next generation Exubera pulmonary inhaler device it could negatively impact our revenue and results of operations. If product liability lawsuits are brought against us, we may incur substantial liabilities. If we fail to establish future successful collaborative relationships, then our results of operation and financial condition may be adversely impacted. If the collaborative partners we depend on to obtain regulatory approvals for and commercialize our partner products are not successful, or if such collaborations fail, then the product development or commercialization of our partner products may be delayed or unsuccessful. If our preclinical testing or clinical trials or those of our collaborative partners are delayed or unsuccessful, our business could be significantly harmed. We depend on third parties in the conduct of our proprietary product candidate clinical trials and any failure of those parties to fulfill their obligations could adversely affect our development and commercialization plans. If we or our partners do not obtain regulatory approval for our product candidates on a timely basis or at all, or if the terms of any approval impose significant restrictions or limitations on use, then our revenues and results of operations may be affected negatively. Our collaboration agreements with our partners contain complex commercial terms that could result in disputes or litigation that could materially and adversely affect our revenues, results of operations, or financial condition. Because our proprietary product candidates are in the early stages of development, there is a high risk of failure, and we may never succeed in developing marketable products or generating revenue from our proprietary product candidates. Our investment in the development and commercialization of our proprietary product candidates prior to seeking partnering arrangements may be unsuccessful and adversely impact our results of operations and financial condition. We may incur substantial litigation costs and liabilities, which may adversely affect our business, results of operations and financial position. If any of our pending patent applications do not issue or following issuance are deemed invalid, we may lose valuable intellectual property protection. We rely on trade secret protection for important proprietary technologies. We may be required to obtain intellectual property licenses from third parties and there is a risk we may not be able to obtain such licenses on a commercially reasonable basis, if at all. There is significant competition for our technology platforms and partnered and proprietary product and product candidates which could make our products, product candidates or technologies obsolete or uncompetitive and it would negatively impact our revenues and results of operations. If government and private insurance programs do not provide reimbursement for our partnered products or proprietary products, those products will not be widely accepted and it would have a negative impact on our revenue and results of operations. If we are not able to manufacture products in accordance with cGMP in commercially feasible quantities or at commercially feasible costs, then our proprietary product candidates or those of our partners will not be successfully commercialized. If earthquakes and other catastrophic events strike, our business may be negatively affected. If we do not generate sufficient cash flow through increased revenues or raising additional capital, then we may not be able to meet our substantial debt obligations. If we cannot raise additional capital our financial condition may suffer. We recently appointed a new President and Chief Executive Officer and any failure or delay in successfully transitioning duties and responsibilities could have a negative impact on our business. Anti-takeover provisions in our charter documents and under Delaware law may make it more difficult to acquire us, even though such acquisitions may be beneficial to our stockholders. We expect our stock price to remain volatile.

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906709--3/1/2007--NEKTAR_THERAPEUTICS