353569--2/26/2010--QUIDEL_CORP

related topics

{product, market, service}

{cost, regulation, environmental}

{product, liability, claim}

{customer, product, revenue}

{regulation, government, change}

{condition, economic, financial}

{operation, international, foreign}

{control, financial, internal}

{property, intellectual, protect}

{personnel, key, retain}

{acquisition, growth, future}

{loss, insurance, financial}

{product, candidate, development}

To remain competitive, we must continue to develop or obtain proprietary technology rights; otherwise, other companies may increase their market share by selling technologically superior products that compete with our products. In order to remain competitive and profitable, we must expend considerable resources to research new technologies and products and develop new markets. Our failure to successfully introduce new technologies and 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 total revenue. The loss of any key distributor or an unsuccessful effort to directly distribute our products could lead to reduced sales. Our operating results are heavily dependent on sales of our influenza diagnostic tests. If we are not able to manage our growth strategy or if we experience difficulties integrating companies or technologies we may acquire after the acquisition, our earnings may be adversely affected. Intellectual property risks and third-party claims of infringement, misappropriation of proprietary rights or other claims against us could adversely affect our ability to market our products, require us to redesign our products or seek licenses from third parties, and materially adversely affect our operating results. In addition, the defense of such claims could result in significant costs and divert the attention of our management and other key employees. Volatility and disruption to the global capital and credit markets may adversely affect our results of operations and financial condition, as well as our ability to access credit and the financial soundness of our customers and suppliers. 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 providers 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 total revenue could be affected by third-party reimbursement policies and potential cost constraints. Unexpected increases in, or inability to meet, current 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. 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 stifle our growth opportunities. Investor confidence and share value may be adversely impacted if we or our independent registered public accounting firm conclude that our internal controls over financial reporting are not effective.

Full 10-K form ▸

353569--2/26/2010--QUIDEL_CORP_/DE/