1131517--3/30/2006--CORGENTECH

related topics

{product, candidate, development}

{product, liability, claim}

{property, intellectual, protect}

{product, market, service}

{acquisition, growth, future}

{control, financial, internal}

{cost, regulation, environmental}

{cost, operation, labor}

{regulation, change, law}

{personnel, key, retain}

{stock, price, operating}

{stock, price, share}

{provision, law, control}

Risk Factors Relating to Our Business If we fail to obtain U.S. regulatory approvals for product candidates under development, we will not be able to generate revenue in the U.S. market. If our preclinical tests or clinical trials with respect to our product candidates do not meet safety or efficacy endpoints in these evaluations, or if we experience significant delays in these tests or trials, our ability to commercialize products and our financial position will be impaired. To obtain regulatory approval to market our product candidate 1207, we will need to conduct nonclinical studies in animals, and the results of these nonclinical studies may not demonstrate adequate efficacy and, even if they do, the results may not necessarily be predictive of results in human trials. There may be delays in developing a product candidate as a result of the necessary preclinical studies to assess the safety of the product candidate including its ability to cause cancer and interactions with other drugs. Failure to enroll patients for clinical trials may cause delays in developing the product candidates, and delays in the commencement of clinical testing of the current product candidates could result in increased costs to us and delay our ability to generate revenues. It may require longer and larger clinical trials to study a product candidate for certain indications such as chronic conditions. If third-party clinical research organizations do not perform in an acceptable and timely manner, our clinical trials could be delayed or unsuccessful. We have limited manufacturing capabilities and manufacturing personnel and expect to depend on third-party manufacturing. If our third-party manufacturers facilities do not follow current good manufacturing practices, our product development and commercialization efforts may be harmed. Even if our products are approved by regulatory authorities, if we fail to comply with ongoing regulatory requirements, or if we experience unanticipated problems with our products, these products could be subject to restrictions or withdrawal from the market. Failure to obtain regulatory approval in foreign jurisdictions will prevent us from marketing our products abroad. We have only limited experience in regulatory affairs, which may affect our ability or the time required to obtain necessary regulatory approvals. If we do not find collaborators for our product candidates, we may have to reduce or delay our rate of product development and/or increase our expenditures. We have no experience selling, marketing or distributing products and have minimal capabilities to do so. Our competitors currently offer and may develop therapies that reduce the size of our markets. If we fail to obtain an adequate level of reimbursement for our products by third-party payors, there may be no commercially viable markets for our products or the markets may be much smaller than expected. We have a limited operating history and if we do not generate significant revenues, we will not be able to achieve profitability. We will need additional financing, which may be difficult to obtain. If we fail to obtain necessary financing or do so on unattractive terms, our development programs and other operations could be harmed. We depend on our officers and key employees, and if we are not able to retain them or recruit additional qualified personnel, our business will suffer. As a result of the restructuring we announced on December 16, 2005, we may be unable to retain employees and experience significant delays in recruiting new employees in the future. Risks Related to Our Industry We face the risk of product liability claims and may not be able to obtain insurance. Our operations involve hazardous materials and we must comply with environmental laws and regulations, which can be expensive. The life sciences industry is highly competitive and subject to rapid technological change. Legislative or regulatory reform of the healthcare system may affect our ability to sell our products profitably. Risk Factors Relating to Our Intellectual Property If we are unable to obtain and maintain protection for the intellectual property incorporated into our products, the value of our technology and products will be adversely affected. If we lose our licenses from PowderMed Limited for 3268, certain individuals for 4975 or Bridge Pharma, Inc. for 1207, and Brigham and Women s Hospital and Stanford University for TF Decoy technology, we will not be able to continue development of its current products. We may incur substantial costs enforcing our patents, defending against third-party patents, invalidating third-party patents or licensing third-party intellectual property, as a result of litigation or other proceedings relating to patent and other intellectual property rights. Changes in, or interpretations of, accounting rules and regulations, such as expensing of stock options, could result in unfavorable accounting charges or require us to change our compensation policies. Anti-takeover defenses that we have in place could prevent or frustrate attempts by stockholders to change the direction or management of the company. Our principal stockholders and management own a significant percentage of our stock and are able to exercise significant influence. If our stock price is volatile, purchasers of our common stock could incur substantial losses. Integrating our merged companies may divert management s attention away from our operations.

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1131517--3/30/2006--CORGENTECH_INC