UNITED STATES SECURITIES and EXCHANGE COMMISSION Washington, D.C

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________________________________________________________________ FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended: December 31, 2019 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number 001-35092 _____________________________________________________________________________ EXACT SCIENCES CORPORATION (Exact name of registrant as specified in its charter) Delaware 02-0478229 (State or other jurisdiction of (IRS Employer incorporation or organization) Identification No.) 441 Charmany Drive, Madison, Wisconsin 53719 (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code: (608) 284‑ 5700 Securities registered pursuant to Section 12(b) of the Act: Common Stock, $0.01 Par Value EXAS The Nasdaq Stock Market LLC Securities registered pursuant to Section 12(g) of the Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes x No ¨ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ¨ No x Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such report(s), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨ Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No ¨ Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10‑ K or any amendment to this Form 10‑ K. x Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b‑ 2 of the Exchange Act. (Check one): Large accelerated filer x Accelerated filer ¨ Non‑ accelerated filer ¨ Smaller reporting company ☐ (Do not check if a smaller reporting company) Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨ Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b‑ 2 of the Act). Yes ☐ No x The aggregate market value of the voting and non-voting common equity held by non-affiliates of the Registrant, as of the last business day of the Registrant’s most recently completed second fiscal quarter was approximately $15,069,783,760 (based on the closing price of the Registrant’s Common Stock on June 28, 2019 of $118.04 per share). The number of shares outstanding of the Registrant’s $0.01 par value Common Stock as of February 19, 2020 was 147,967,507. DOCUMENT INCORPORATED BY REFERENCE The registrant intends to file a definitive proxy statement pursuant to Regulation 14A within 120 days after the end of the fiscal year ended December 31, 2019. Portions of such proxy statement are incorporated by reference into Part III of this Form 10‑ K. EXACT SCIENCES CORPORATION PART I ANNUAL REPORT ON FORM 10‑ K YEAR ENDED DECEMBER 31, 2019 This Annual Report on Form 10‑ K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are TABLE OF CONTENTS intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on Page No. certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of Part I forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate” or other comparable terms. All statements other than statements of historical Business Item 1. 4 facts included in this Annual Report on Form 10‑ K regarding our strategies, prospects, expectations, financial Item 1A. Risk Factors 24 condition, operations, costs, plans and objectives are forward-looking statements. Examples of forward-looking Item 1B. Unresolved Staff Comments 54 statements include, among others, statements we make regarding expected future operating results, anticipated results of our sales, marketing and patient adherence efforts, expectations concerning payer reimbursement and regulatory Item 2. Properties 54 matters, the anticipated results of our product development efforts and the anticipated benefits of our combination with Item 3. Legal Proceedings 54 Genomic Health, Inc., including estimated synergies and other financial impacts. Forward-looking statements are Item 4. Mine Safety Disclosures 55 neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, Part II expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated Item 5. Market for Registrant’s Common Equity, Related Shareholder Matters and Issuer Purchases of 56 events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, Equity Securities they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of Item 6. Selected Financial Data 56 which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 57 Important factors that could cause our actual results and financial condition to differ materially from those indicated in Item 7A. Quantitative and Qualitative Disclosures about Market Risk 68 the forward-looking statements include, among others, the following: our ability to successfully and profitably market Item 8. Financial Statements and Supplementary Data 69 our products and services; the acceptance of our products and services by patients and healthcare providers; our ability Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 125 to meet demand for our products and services; the willingness of health insurance companies and other payers to cover our products and services and adequately reimburse us for such products and services; the amount and nature of Item 9A. Controls and Procedures 125 competition in the cancer detection, treatment guidance and monitoring space; the effects of the adoption, modification Item 9B. Other Information 126 or repeal of any law, rule, order, interpretation or policy relating to the healthcare system, including without limitation Part III as a result of any judicial, executive or legislative action; the effects of changes in pricing, coverage and reimbursement Item 10. Directors, Executive Officers and Corporate Governance 126 for our products and services, including without limitation as a result of the Protecting Access to Medicare Act of 2014; recommendations, guidelines and quality metrics issued by various organizations such as the U.S. Preventive Services Item 11. Executive Compensation 126 Task Force, the American Society of Clinical Oncology, the American Cancer Society, and the National Committee for Item 12. Security and Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 126 Quality Assurance regarding cancer screening or our products and services; our ability to successfully develop new Item 13. Certain Relationships and Related Transactions, and Director Independence 126 products and services and assess potential market opportunities; our ability to effectively utilize strategic partnerships, Item 14. Principal Accountant Fees and Services 126 such as through our Promotion Agreement with Pfizer, Inc., and acquisitions; our success establishing and maintaining collaborative, licensing and supplier arrangements; our ability to maintain regulatory approvals and comply with Part IV applicable regulations; our ability to manage an international business and our expectations regarding our international Item 15. Exhibits and Financial Statement Schedules 127 expansion and opportunities; the potential effects of foreign currency exchange rate fluctuations and our efforts to Item 16. Form 10-K Summary 131 hedge such effects; the possibility that the anticipated benefits from our combination with Genomic Health cannot be SIGNATURES 132 realized in full or at all or

Load more