1314102--9/25/2009--pSivida

related topics

{product, candidate, development}

{stock, price, share}

{stock, price, operating}

{product, liability, claim}

{control, financial, internal}

{property, intellectual, protect}

{personnel, key, retain}

{competitive, industry, competition}

{acquisition, growth, future}

{tax, income, asset}

{cost, regulation, environmental}

RISKS RELATED TO OUR COMPANY AND OUR BUSINESS We may be required to seek additional capital in order to fund our operations, and our ability to obtain additional capital is uncertain. We have a history of losses, we expect to continue to incur losses and we may never become profitable. We do not currently derive revenue from Retisert, and there is no assurance that Retisert will ever be a material source of revenue. Our results could be adversely affected as a result of the impact of impairment of our intangible assets, which could adversely affect the price of our securities. Our results could be adversely affected by non-cash charges due to fluctuations in the fair values of certain of our outstanding warrants, which could adversely affect the price of our securities. Our operating results may fluctuate significantly from period to period. RISKS RELATED TO THE DEVELOPMENT AND COMMERCIALIZATION OF OUR PRODUCTS Certain of our current licensees may terminate their agreements with us at any time, and if they do, we may not be able to effectively develop and sell our products. If we or our licensees do not receive the necessary regulatory approvals, we or our licensees will be unable to commercialize our product candidates. We have a limited ability to develop and market products ourselves. If we are unable to find marketing or commercialization partners, or our marketing or commercialization partners do not successfully develop or market our products, we may be unable to effectively develop and market products on our own. If our competitors and potential competitors develop products that receive regulatory approval before our product candidates are approved or reach the market prior to our product candidates, are more effective or have fewer side effects than our products or product candidates or are more effectively marketed or cost less, our products or product candidates may not achieve the sales we anticipate and could be rendered obsolete. Reimbursement of our products by government health administration authorities and other third-party payors could affect market acceptance. RISKS RELATED TO OUR INTELLECTUAL PROPERTY We rely heavily upon patents and trade secrets to protect our proprietary technologies. If we fail to protect our intellectual property or infringe on others technologies, our ability to develop and market our products and product candidates may be compromised. RISKS RELATED TO OUR BUSINESS, INDUSTRY, STRATEGY AND OPERATIONS If we fail to retain some or all of our key personnel, our business could suffer. If we are subject to product liability suits, we may not have sufficient insurance to cover damages. The trend towards consolidation in the pharmaceutical and biotechnology industries may adversely affect us. If we fail to comply with environmental laws and regulations, our ability to manufacture and commercialize products may be adversely affected. If we encounter problems with product manufacturing, we could experience delays in product development and commercialization, which would adversely affect our future profitability. Problems associated with international business operations could affect our ability to manufacture and sell our products. If we encounter such problems, our costs could increase and our development of products could be delayed. RISKS RELATED TO OUR COMMON STOCK The price of our common stock may be volatile. If the holders of our outstanding warrants and stock options exercise their warrants and options, your ownership may be diluted and our stock price may decline. Pfizer owns a significant percentage of our common stock and is a collaborative partner and therefore may be able to influence our business in ways that are not beneficial to you. We have paid penalties pursuant to registration agreements with securities holders relating to resale registration statements, and any requirement to pay such penalties in the future may have a material adverse effect on our financial condition. We do not currently intend to pay dividends on our common stock, and any return to investors will come, if at all, only from potential increases in the price of our common stock.

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1314102--9/25/2009--pSivida_Corp.