QDEL Quidel Corp

Risks

• Our operating results may fluctuate adversely as a result of many factors that are outside our control, which may negatively impact our stock price.
• To remain competitive, we must continue to develop, obtain and protect our proprietary technology rights; otherwise, we may lose market share or need to reduce prices as a result of competitors selling lower priced or 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, and there is no assurance our efforts to develop new technologies, products or markets will be successful or such technologies, products or markets will be commercially viable.
• Our operating results are heavily dependent on sales of our influenza diagnostic tests and if sales or revenues of our influenza tests decline for any reason, our operating results would be materially and adversely affected on a disproportionate basis.
• We rely on a limited number of key distributors that account for a significant portion of our total revenue. The loss of any key distributor or an unsuccessful effort by us to directly distribute our products could lead to reduced sales.
• We are subject to, and may in the future become subject to, claims and litigation that could result in significant expenses and could ultimately result in an unfavorable outcome for us.
• 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 attempt to 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.
• We may need to raise additional funds to finance our future capital or operating needs, which could have adverse consequences on our operations and the interests of our stockholders.
• Our results of operations and financial condition may be adversely affected by the financial soundness of our customers and suppliers.
• We may not achieve market acceptance of our products among healthcare providers and physicians, and this would have a negative effect on future sales.
• The industry and market segment in which we operate are highly competitive, and intense competition with other providers of diagnostic products may reduce our sales and margins.
• Our business and products are highly regulated by various governmental agencies. Our results of operations would be negatively affected by failures or delays in the receipt of regulatory approvals or clearances, the loss of previously received approvals or other changes to existing laws and regulations that adversely impact our ability to manufacture and market our products.
• Changes in government policy could adversely affect our business and profitability.
• We are subject to numerous government regulations in addition to FDA regulation, and compliance with laws, including changed or new laws, could increase our costs and adversely affect our operations.
• 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.
• Billing and payment for healthcare services are highly regulated, and the failure to comply with applicable laws and regulations can result in civil or criminal sanctions, including exclusion from federal and state healthcare programs.
• Unexpected increases in, or inability to meet, demand for our products could require us to spend considerable resources to meet the demand or harm our reputation and customer relationships if we are unable to meet demand.
• Interruptions in the supply of raw materials and other products and services could adversely affect our operations and financial results.
• If one or more of our products is claimed to be defective, we could be subject to claims of liability and harm to our reputation 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 results of operations.
• Failures in our information technology and storage systems could significantly disrupt our business or force us to expend excessive costs.
• Our ability to protect our information systems and electronic transmissions of sensitive data from data corruption, cyber-based attacks, security breaches or privacy violations is critical to the success of our business.
• 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, that could impact our financial performance, cause interruptions in our current business operations and impede our growth strategy.
• Changes in our tax rates or exposure to additional income tax liabilities or assessments could affect our profitability.
• If we are not able to manage our growth strategy or if we experience difficulties identifying or integrating companies or technologies we may acquire, our operating results may be adversely affected.
• Our acquisition of Alere’s Triage® and BNP Businesses presents certain risks to our business and operations
• If goodwill or other intangible assets that we have recorded in connection with our acquisitions of other businesses become impaired, we may be required to take significant charges against earnings.
• Our debt, deferred and contingent payment obligations could materially adversely affect our financial condition and results of operations.
• We may not be able to generate sufficient cash flow to meet our debt service and deferred and contingent payment obligations, and any inability to repay our debt when due would have a material adverse effect on our business, financial condition and results of operations.
• We will continue to have the ability to incur debt and our levels of debt may affect our operations and our ability to pay the principal of and interest on our debt.
• The Revolving Credit Facility is secured by substantially all of our assets and those of our subsidiary guarantors.
• The agreements relating to our indebtedness contain terms that restrict our ability to operate our business, and as a result, may materially and adversely affect our results of operations.
• An event of default under any agreement relating to our outstanding indebtedness or other event that could require outstanding debt to be prepaid or purchased by us could cross default other indebtedness, which could have a material adverse effect on our business, financial condition and results of operations.
• If interest rates increase, our debt service obligations under our variable rate indebtedness could increase significantly, which could have a material adverse effect on our results of operations.
• Sales of our common stock in the public market could lower the market price for our common stock and adversely impact the trading price of our securities.
• The price of our stock may fluctuate unpredictably in response to factors unrelated to our operating performance.
• We do not anticipate declaring any cash dividends on our common stock.