1226616--2/16/2006--MEDICINOVA

related topics

{product, candidate, development}

{stock, price, share}

{property, intellectual, protect}

{product, liability, claim}

{product, market, service}

{stock, price, operating}

{personnel, key, retain}

{cost, operation, labor}

{provision, law, control}

{control, financial, internal}

{regulation, government, change}

{acquisition, growth, future}

Risks Related to Our Business We expect our net losses to continue for at least several years and we are unable to predict the extent of our future losses. We do not have any products that are approved for commercial sale and therefore do not expect to generate any revenues from product sales in the foreseeable future. The loss of any rights to develop and market any of our product candidates could significantly harm our business. In order to commercialize a therapeutic drug successfully, a product candidate must undergo clinical trials, which are long, complex and costly, manifest a high risk of failure and can be delayed or suspended. If we fail to identify and license or acquire other product candidates, we will not be able to expand our business over the long term. If we fail to obtain the capital necessary to fund our operations, we will be unable to develop and commercialize our product candidates. The terms under which we raise additional capital may harm our business and may significantly dilute stockholders ownership interests. We will depend on strategic collaborations with third parties to develop and commercialize selected product candidates and will not have control over a number of key elements relating to the development and commercialization of these product candidates. We rely on third parties to conduct our clinical trials and perform data collection and analysis, which may result in costs and delays that may hamper our ability to successfully develop and commercialize our product candidates. Our product candidates, if approved for sale, may not gain acceptance among physicians, patients and the medical community, thereby limiting our potential to generate revenues. We are dependent on our management team, particularly Yuichi Iwaki, M.D., Ph.D., and if we are unable to attract, retain and motivate Dr. Iwaki and other key management and scientific staff, our drug development programs may be delayed and we may be unable to develop successfully or commercialize our product candidates. If we are unable to establish our sales and distribution capabilities, we will be unable to successfully commercialize our product candidates. We will need to increase the size of our organization, and we may encounter difficulties managing our growth, which could adversely affect our results of operations. We expect that our results of operations will fluctuate, which may make it difficult to predict our future performance from period to period. Relying on third-party manufacturers may result in delays in our clinical trials and product introductions as well as increased costs. We may not be able to manufacture our product candidates in commercial quantities, which would prevent us from commercializing our product candidates. Materials necessary to manufacture our products may not be available on commercially reasonable terms, or at all, which may delay the development and commercialization of our products. Risks Related to Our Intellectual Property Our ability to compete may decline if we do not adequately protect our proprietary rights. A dispute concerning the infringement or misappropriation of our proprietary rights or the proprietary rights of others could be time consuming and costly, and an unfavorable outcome could harm our business. Risks Related to Our Industry We are subject to stringent regulation of our product candidates, which could delay the development and commercialization of our products. If our competitors develop and market products that are more effective than our product candidates, they may reduce or eliminate our commercial opportunities. Rapid technological change could make our products obsolete. Consumers may sue us for product liability, which could result in substantial liabilities that exceed our available resources and damage our reputation. Health care reform measures could adversely affect our business. Risks Related to the Market for our Common Stock Our stock price may be volatile, and you may not be able to resell our shares at a profit or at all. If the holders of the shares offered by the registration statement dated September 19, 2005, or the registration statement dated November 23, 2005 were to determine to sell all or a significant portion of their shares at one time, there would be significant downward pressure on our stock price and it may be difficult to sell your shares. Anti-takeover provisions in our charter documents and under Delaware law may make an acquisition of us more complicated and the removal and replacement of our directors and management more difficult. We have never paid dividends on our capital stock, and we do not anticipate paying any cash dividends in the foreseeable future.

Full 10-K form ▸

1226616--2/16/2006--MEDICINOVA_INC