353569--3/9/2006--QUIDEL_CORP

related topics

{product, market, service}

{cost, regulation, environmental}

{stock, price, share}

{stock, price, operating}

{product, liability, claim}

{regulation, change, law}

{customer, product, revenue}

{regulation, government, change}

{control, financial, internal}

{property, intellectual, protect}

{operation, international, foreign}

{acquisition, growth, future}

{personnel, key, retain}

{provision, law, control}

{loss, insurance, financial}

Risks Related to Our Business Our operating results may fluctuate adversely as a result of many factors that are outside our control. We are involved in pending, and may become involved in future, intellectual property infringement disputes, which are costly and could limit or eliminate our ability to use certain of our core technologies in the future and sell our products. To remain competitive, we must continue to develop or obtain proprietary technology rights; otherwise, other companies may increase their market share by selling products that compete with our products. In order to remain competitive and profitable, we must expend considerable resources to introduce new technologies and products and develop new markets. Our failure to successfully introduce new technologies, new products and develop new markets could have a material adverse effect on our business and prospects. We rely on a limited number of key distributors which account for a substantial majority of our net sales. The loss of any key distributor or an unsuccessful effort to directly distribute our products could lead to reduced sales. We may not achieve market acceptance of our products among physicians and other healthcare providers, and this would have a negative effect on future sales growth. Intense competition with other manufacturers of POC diagnostic products may reduce our sales. Our products are highly regulated by various governmental agencies. Any changes to the existing laws and regulations may adversely impact our ability to manufacture and market our products. We are subject to numerous government regulations in addition to FDA regulation, and compliance with changes could increase our costs. We use hazardous materials in our business that may result in unexpected and substantial claims against us relating to handling, storage or disposal. Our net sales could be affected by third-party reimbursement policies and potential cost constraints. Unexpected increases in demand for our products could require us to spend considerable resources to meet the demand or harm our customer relationships if we are unable to meet demand. If one or more of our products proves to be defective, we could be subject to claims of liability that could adversely affect our business. We are exposed to business risk which, if not covered by insurance, could have an adverse effect on our profits. If we are not able to manage our growth strategy and if we experience difficulties integrating companies or technologies we may acquire after the acquisition, our earnings may be adversely affected. Our business could be negatively affected by the loss of or the inability to hire key personnel. We face risks relating to our international sales, including inherent economic, political and regulatory risks, which could increase our costs, cause interruptions in our current business operations and/or stifle our growth opportunities. Evolving regulation of corporate governance and public disclosure may result in additional expenses and continuing uncertainty. Investor confidence and share value may be adversely impacted if we and/or our independent registered public accounting firm conclude that our internal controls over financial reporting are not effective. Future changes in financial accounting standards or practices or existing taxation rules or practices may affect our reported results of operations. Risks Related to Our Common Stock Our stock price has been highly volatile, and an investment in our stock could suffer a significant decline in value. Future sales by existing stockholders could depress the market price of our common stock. Anti-takeover devices may prevent a sale, or changes in the management, of the Company. We do not pay dividends and this may negatively affect the price of our stock.

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