802724--3/15/2007--INSITE_VISION

related topics

{product, candidate, development}

{product, liability, claim}

{stock, price, operating}

{product, market, service}

{property, intellectual, protect}

{acquisition, growth, future}

{control, financial, internal}

{personnel, key, retain}

{regulation, change, law}

{provision, law, control}

{cost, regulation, environmental}

{customer, product, revenue}

{financial, litigation, operation}

{cost, operation, labor}

Our current cash will only fund our business until approximately the end of June 2007. We will need additional funding, either through achievement of a licensing milestone, equity or debt financings or partnering arrangements, that, if available, could be further dilutive to our stockholders and could negatively affect us and our stock price Clinical trials are very expensive, time-consuming and difficult to design and implement and it is unclear whether the results of such clinical trials will be favorable The results of our clinical trials may not support our product candidate claims Our current financial situation may impede our ability to protect or enforce adequately our legal rights under our agreements and intellectual property Our strategy for research, development and commercialization of our products requires us to enter into various arrangements with corporate and academic collaborators, licensors, licensees and others; furthermore, we are dependent on the diligent efforts and subsequent success of these outside parties in performing their responsibilities Inspire s failure to successfully market and commercialize AzaSite would negatively impact our future revenues Our license of AzaSite to Inspire may not be profitable for us Inspire has limited experience in sales and marketing of pharmaceutical products Revenues in future periods could vary significantly and will be based on Inspire s financial reports Our future success depends on our ability to enter into successful collaboration arrangements with third parties in order to develop new products and new indications for existing products that achieve regulatory approval for commercialization Physicians and patients may not accept and use our products Questions concerning our financial condition may cause customers and current and potential partners to reduce or not conduct business with us We may require additional licenses or be subject to expensive and uncertain patent litigation in order to sell AzaSite in the United States and/or Europe Our business depends upon our proprietary rights, and we may not be able to protect, enforce or secure our intellectual property rights adequately It is difficult to evaluate our business because we are in an early stage of development and our technology is untested We are dependent upon key employees and we may not be able to retain or attract key employees, and our ability to attract and retain key employees is likely to be harmed by our current financial situation We have a history of operating losses and we expect to continue to have losses in the future We may not successfully manage growth Our products are subject to government regulations and approvals which may delay or prevent the marketing of potential products and impose costly procedures upon our activities We have no experience in performing the analytical procedures related to genetic testing and have established an exclusive commercial agreement with a third party to perform these procedures for our OcuGene glaucoma genetic test; If we are unable to maintain this arrangement, and are unable to establish new arrangements with third parties, we will have to establish our own regulatory compliant analytical process for genetic testing and may not have the financial resources to do so We rely on a sole source for some of the raw materials in our products, including AzaSite, and the raw materials we need may not be available to us We have no experience in commercial manufacturing and if contract manufacturing is not available to us or does not satisfy regulatory requirements, we will have to establish our own regulatory compliant manufacturing capability and may not have the financial resources to do so We compete in highly competitive markets and our competitors financial, technical, marketing, manufacturing and human resources may surpass ours and limit our ability to develop and/or market our products and technologies If we cannot compete successfully for market share against other drug companies, we may not achieve sufficient product revenues and our business will suffer Uncertainties regarding healthcare reform and third-party reimbursement may impair our ability to raise capital, form collaborations and sell our products Our insurance coverage may not adequately cover our potential product liability exposure Our use of hazardous materials may pose environmental risks and liabilities which may cause us to incur significant costs If we engage in acquisitions, we will incur a variety of costs, and the anticipated benefits of the acquisitions may never be realized Management and principal stockholders may be able to exert significant control on matters requiring approval by our stockholders The market prices for securities of biopharmaceutical and biotechnology companies such as ours have been and are likely to continue to be highly volatile due to reasons that are related and unrelated to our operating performance and progress We have adopted and are subject to anti-takeover provisions that could delay or prevent an acquisition of our Company and could prevent or make it more difficult to replace or remove current management Legislative actions, higher insurance costs and potential new accounting pronouncements are likely to impact our future financial position and results of operations

Full 10-K form ▸

802724--3/15/2007--INSITE_VISION_INC