1040416--3/16/2006--INSPIRE_PHARMACEUTICALS

related topics

{product, candidate, development}

{product, liability, claim}

{stock, price, operating}

{financial, litigation, operation}

{property, intellectual, protect}

{regulation, change, law}

{cost, contract, operation}

{customer, product, revenue}

{cost, regulation, environmental}

{personnel, key, retain}

{provision, law, control}

{competitive, industry, competition}

{cost, operation, labor}

{stock, price, share}

If the FDA does not conclude that our product candidates meet statutory requirements for safety and efficacy, we will be unable to obtain regulatory approval for marketing in the United States, and if foreign governments do not conclude that our product candidates meet their requirements for marketing, we will be unable to sell those product candidates in those foreign markets. Failure to successfully market and commercialize will negatively impact our revenues. Revenues in future periods could vary significantly and may not cover our operating expenses. Failure to adequately market and commercialize diquafosol, if approved by the FDA, will limit our revenues. or any of our product candidates if governmental approvals are not obtained and maintained. We have been named as a defendant in litigation that could result in substantial damages and costs and divert management s attention and resources. The investigation by the U.S. Securities and Exchange Commission could have a material adverse effect on our business. Recent Medicare prescription drug coverage legislation and future legislative or regulatory reform of the healthcare system may affect our or our partner s ability to sell products profitably. Future implementation of certain government initiatives could create risks for our business. Failure to adequately control compliance with all applicable regulations may adversely affect our business. Since our clinical candidates utilize new or different mechanisms of action and in some cases there may be no regulatory precedents, conducting clinical trials and obtaining regulatory approval may be difficult, expensive and prolonged, which would delay any marketing of our products. Estimated development costs are difficult to project and may change frequently prior to regulatory approval. If we are not able to obtain sufficient additional funding to meet our expanding capital requirements, we may be forced to reduce or eliminate research programs and product development. Clinical trials may take longer to complete and cost more than we expect, which would adversely affect our ability to commercialize product candidates and achieve profitability. Our common stock price has been volatile and your investment in our stock may decline in value. If we continue to incur operating losses for a period longer than anticipated, or in an amount greater than anticipated, we may be unable to continue our operations. If we fail to reach milestones or to make annual minimum payments or otherwise breach our obligations under our license agreements, our licensors may terminate our agreements with them. Reliance on a single party to manufacture and supply either finished product or the bulk active pharmaceutical ingredients for a product or product candidates could adversely affect us. If we are unable to contract with third parties for the synthesis of APIs required for preclinical testing, for the manufacture of drug products for clinical trials, or for the large-scale manufacture of any approved products, we may be unable to develop or commercialize our drug products. We may not be successful in our efforts to expand our product portfolio. Our dependence on collaborative relationships may lead to delays in product development, lost revenues and disputes over rights to technology. We may not be able to successfully compete with other biotechnology companies and established pharmaceutical companies. We will rely substantially on third parties to market, distribute and sell our products and those third parties may not perform. We have had limited experience in sales, marketing or distribution of products. Failure to hire and retain key personnel or to identify, appoint and elect qualified directors, may hinder our product development programs and our business efforts. If our patent protection is inadequate, the development and any possible sales of our product candidates could suffer or competitors could force our products completely out of the market. Since we rely upon trade secrets and agreements to protect some of our intellectual property, there is a risk that unauthorized parties may obtain and use information that we regard as proprietary. If physicians and patients do not accept our product candidates, they will not be commercially successful. Our operations involve a risk of injury from hazardous materials, which could be very expensive to us. Use of our products may result in product liability claims for which we may not have adequate insurance coverage. Insurance coverage is increasingly more costly and difficult to obtain or maintain. Future sales by stockholders into the public market may cause our stock price to decline. Our Rights Agreement, the provisions of our Change in Control Severance Benefit Plan and our Change in Control Agreements with management, the anti-takeover provisions in our Restated Certificate of Incorporation and Amended and Restated Bylaws, and our right to issue preferred stock, may discourage a third party from making a take-over offer that could be beneficial to us and our stockholders and may make it difficult for stockholders to replace our Board of Directors and effect a change in our management if they desire to do so.

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1040416--3/16/2006--INSPIRE_PHARMACEUTICALS_INC