819050--3/10/2006--VICAL

related topics

{product, candidate, development}

{product, liability, claim}

{property, intellectual, protect}

{stock, price, share}

{provision, law, control}

{cost, regulation, environmental}

{stock, price, operating}

{control, financial, internal}

{personnel, key, retain}

{product, market, service}

{acquisition, growth, future}

{regulation, government, change}

None of our independently developed products has been approved for sale, and we have a limited number of independent product candidates in clinical trials. If we do not develop commercially successful products, we may be forced to curtail or cease operations. We may not be able to identify and reach agreement with a potential partner for the further development and commercialization of Allovectin-7 . Our revenues partially depend on the development and commercialization of products by others to whom we have licensed our technologies. If our collaborators or licensees are not successful or if we are unable to find collaborators or licensees in the future, we may not be able to derive revenues from these arrangements. Some of our independent product candidates and some of those under development by our sublicensees incorporate technologies we have licensed from others. If we are unable to retain rights to use these technologies, we or our sublicensees may not be able to market products incorporating these technologies on a commercially feasible basis, if at all. A significant portion of our revenue is derived from agreements with government agencies, which are subject to termination and uncertain future funding. We have a history of net losses. We expect to continue to incur net losses and we may not achieve or maintain profitability. We may need additional capital in the future. If additional capital is not available, we may have to curtail or cease operations. The regulatory approval process is expensive, time consuming and uncertain, which may prevent us from obtaining required approvals for the commercialization of our products. Adverse events in the field of gene therapy, or with respect to our product candidates, may negatively impact regulatory approval or public perception of our products. Our patents and proprietary rights may not provide us with any benefit and the patents of others may prevent us from commercializing our products. The legal proceedings to obtain and defend patents, and litigation of third-party claims of intellectual property infringement, could require us to spend money and could impair our operations. Competition and technological change may make our product candidates and technologies less attractive or obsolete. If we lose our key personnel or are unable to attract and retain additional personnel, we may not be able to achieve our business objectives. We have limited experience in manufacturing our product candidates in commercial quantities. We may not be able to comply with applicable manufacturing regulations or produce sufficient product for contract or commercial purposes. We may initially depend on third parties to manufacture our product candidates commercially. We have no marketing or sales experience, and if we are unable to develop our own sales and marketing capability, we may not be successful in commercializing our products. Healthcare reform and restrictions on reimbursement may limit our returns on potential products. We use hazardous materials in our business. Any claims relating to improper handling, storage or disposal of these materials could be time consuming and costly. We may have significant product liability exposure. Our stock price could continue to be highly volatile and you may not be able to resell your shares at or above the price you pay for them. We are at risk of securities class action litigation due to our expected stock price volatility. Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management. The issuance of preferred stock could adversely affect our common stockholders.

Full 10-K form ▸

819050--3/10/2006--VICAL_INC