QDEL Quidel Dashboard

Risks

• The novel coronavirus global pandemic could adversely affect our business operations, financial performance and results of operations, the extent of which is uncertain and difficult to predict.
• The industry and market segment in which we operate are highly competitive, and intense competition with other providers of diagnostic products or services may reduce our sales and margins.
• Our operating results are heavily dependent on sales of our COVID-19 and influenza diagnostic tests and if sales or revenues of our COVID-19 or influenza tests decline for any reason, our operating results would be materially and adversely affected.
• 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.
• 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 physicians, healthcare providers or other customers, and this would have a negative effect on future sales.
• Our total revenue could be affected by third-party reimbursement policies and potential cost constraints.
• Unexpected increases in, or inability to meet, demand for our products and services 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, components, equipment and other products and services could adversely affect our operations and financial results.
• Failures in our information technology and storage systems, including as a result of cyber-security breaches, could significantly disrupt our business or force us to expend excessive costs.
• 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.
• Continuing worldwide political and social uncertainty, including tariffs, trade wars or social tensions, may adversely affect our business and prospects, both domestically and internationally.
• To remain competitive, we must continue to develop and obtain 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 or services that compete with our products.
• 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.
• Our COVID-19 products were approved by the FDA through an EUA and the loss of such authorization could have a material adverse impact on our business, results of operations, financial position and cash flows.
• 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, clearances or authorizations, 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.
• Our contracts with government entities involve future funding, compliance, and possible sanctions risks
• 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 use hazardous materials in our business that may result in substantial claims against us relating to handling, storage or disposal.
• 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
• 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 debt, deferred and contingent payment obligations could materially adversely affect our financial condition and results of operations.
• Our business could be negatively affected by the loss of or the inability to hire key personnel.
• 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.
• We are exposed to business risk which, if not covered by insurance, could have an adverse effect on our results of operations.
• Changes in our tax rates or exposure to additional income tax liabilities or assessments could affect our profitability.
• Some provisions of our charter documents and Delaware law may make takeover attempts difficult, which could depress the price of our stock and inhibit our stockholders’ ability to receive a premium price for their shares.