Exact Sciences

Madison, Wisconsin · Research and development, corporate, operations, and clinical laboratory · 1,514,017 · Leased/Owned

Redwood City, California · Research and development, corporate, operations, and clinical laboratory · 243,195 · Leased

See Note 14 in the Notes to Consolidated Financial Statements for further discussion surrounding our leased facilities.

• We may never become profitable or sustain profitability.
• We may need additional capital to execute our strategic plan.
• Our success depends heavily on our Screening and Precision Oncology tests and the successful commercialization of our tests in development.
• Our operating results could be subject to significant fluctuation, which could increase the volatility of our stock price and cause losses to our shareholders.
• We face intense competition from other companies and may not be able to compete successfully.
• If any of our facilities or our laboratory equipment were damaged or destroyed, or if we experience a significant disruption in our operations for any reason, our ability to continue to operate our business could be materially harmed.
• We heavily rely upon certain suppliers and other vendors, and any disruptions or failures with respect to our relationships with these counterparties could have a disruptive effect on our business.
• Cyberattacks, security breaches, loss of data, and other disruptions in relation to our information technology systems, as well as those of our third-parties with whom we have business relationships, could compromise sensitive information related to our business, prevent us from accessing it and expose us to substantial liability, which could adversely affect our business and reputation.
• We rely on courier delivery services to transport Cologuard collection kits to patients and samples for all of our tests back to laboratory facilities for analysis. If these delivery services are disrupted or become significantly more expensive, customer satisfaction and our business could be negatively impacted.
• The success of our business substantially depends on the efforts of our senior management team and our qualified personnel.
• Our business and reputation will suffer if we are unable to establish and comply with stringent quality standards to assure that the highest level of quality is observed in the performance of our tests.
• Our inability to manage growth could harm our business.
• We may engage in acquisitions or divestitures that are not successful and which could disrupt our business and reduce our financial resources and shareholder value.
• We may not be successful in achieving expected operating efficiencies and sustaining or improving operating margins and may experience business disruptions associated with restructuring and transformation activities.
• International expansion of our business exposes us to business, regulatory, labor, political, operational, financial, liability, compliance, payment collection, and economic risks associated with doing business outside of the U.S.
• Our business may be adversely affected by global macroeconomic conditions and volatility in the capital markets.
• Public health crises, such as the COVID-19 pandemic, have had, and could in the future have, adverse effects on our business and financial results.
• Ethical, legal, and social concerns related to the use of genetic information could reduce demand for our genetic tests.
• Climate change, or legal or regulatory measures to address climate change or other corporate social responsibility and sustainability matters, could adversely affect our business, financial condition, and results of operations.
• The use of Artificial Intelligence presents new risks and challenges to our business.
• We may be a party to litigation in the normal course of business or otherwise, which could affect our business and financial position.
• We face uncertainty related to healthcare reform, pricing, coverage, and reimbursement.
• Healthcare policy changes, including recently enacted legislation reforming the U.S. healthcare system could have an adverse effect on our business, financial condition, results of operations and prospects.
• If payers, including managed care organizations, do not approve and maintain reimbursement for our tests at adequate reimbursement rates, our commercial success could be compromised.
• If we are unable to obtain or maintain reimbursement at adequate reimbursement rates for our Oncotype DX tests outside of the U.S., our ability to expand internationally will be compromised.
• Failure to comply with federal, state, and foreign laboratory licensing and related requirements could cause us to lose the ability to perform our tests, experience disruptions to our business, or become subject to administrative or judicial sanctions.
• Our products could be subject to recall.
• Delays in receipt of, or failure to obtain, required FDA clearances or approvals for our products in development, or improvements to or expanded indications for our current offerings, could materially delay or prevent us from commercializing or otherwise adversely impact future product commercialization.
• Disruptions at the FDA and other government agencies and regulatory authorities caused by government shutdowns, policy changes, funding shortages, or key personnel disruptions could prevent new products and services from being reviewed or approved in a timely manner or at all, or otherwise prevent those agencies from performing normal governmental functions on which the operation of our business may rely, which could negatively impact our business, financial condition and results of operations.
• There exists substantial uncertainty regarding the future regulation of the LDTs.
• We are subject to numerous U.S. and foreign laws and governmental regulations, and any governmental enforcement action may materially affect our financial condition and business operations.
• Due to billing complexities in the diagnostic and laboratory service industry, we may have difficulties receiving timely payment for the tests we perform, and may face write-offs, disputes with payers and patients, and long collection cycles.
• Some of our activities may subject us to risks under federal and state laws prohibiting “kickbacks” and false or fraudulent claims.
• Some of our activities may subject us to risks under the Foreign Corrupt Practices Act and similar anti-bribery laws in non-U.S. jurisdictions.
• Failure to comply with privacy, security, and consumer protection laws and regulations could result in fines, penalties, and damage to our reputation and have a material adverse effect on our business.
• Our employees, independent contractors, consultants, commercial partners, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
• Changes in tax laws or regulations or exposure to tax liabilities could adversely affect our financial condition and results of operations.
• Risks Relating to Product Development, Commercialization, and Sales of our Products
• The success of the screening and diagnostic products and services we currently offer or may offer in the future will depend on the degree of market acceptance by healthcare providers, patients, healthcare payers, and others in the medical community.
• Uncertainty in the development and commercialization of our new tests or services could materially adversely affect our business, financial condition and results of operations.
• If we do not successfully manage the launch and marketing of new products or services, our financial results could be adversely affected.
• Recommendations, guidelines, and quality metrics issued by various organizations may significantly affect payers’ willingness to cover, and healthcare providers’ willingness to prescribe or order, our products.
• We expect to continue to make significant investments in our research and development efforts, which may not be successful.
• Interim, topline and preliminary data from our clinical studies that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
• Our industry is subject to rapid change, which could make our current products and any future products we may develop, obsolete.
• The sizes of the markets for our current and future products have not been established with precision, and may be smaller than we estimate.
• Our dependence on distributors for sales in many countries outside of the U.S. could limit or prevent us from selling our tests in those countries and impact our revenue.
• We rely on strategic collaborative and licensing arrangements with third parties to develop critical intellectual property. We may not be able to successfully establish and maintain such collaborative and license agreements.
• We may be subject to substantial costs and liability or be prevented from using technologies incorporated in our screening or diagnostic tests as a result of litigation or other proceedings relating to patent or other intellectual property rights.
• If we are unable to protect or enforce our intellectual property effectively, we may be unable to prevent third parties from using our intellectual property, which would impair any competitive advantage we may otherwise have.
• If patent regulations or standards are modified, such changes could have a negative impact on our business.
• If we fail to maintain an effective system of internal control over financial reporting, investors may lose confidence in the accuracy and completeness of our reported financial information and our stock price may be adversely impacted.
• Our stock price has fluctuated widely and, despite the pendency of the Merger, may continue to be volatile.
• We have recorded significant impairment charges and could do so again in the future, which could have a material adverse impact on our results of operations.
• Our significant indebtedness could adversely affect our business, financial condition and results of operations, and our ability to meet our payment obligations under such indebtedness and limit our ability to raise additional capital to fund our operations.