UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported):  January 7, 2018

EXACT SCIENCES CORPORATION
(Exact Name of Registrant as Specified in Charter)

Delaware	 	001-35092	 	02-0478229	
(State or Other Jurisdiction
of Incorporation)	 	(Commission
File Number)	 	(I.R.S. Employer
Identification No.)	
 
441 Charmany Drive
Madison, WI  53719
(Address of Principal Executive Offices)(Zip Code)
 
Registrant’s telephone number, including area code:  (608) 284-5700
 
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
o             Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o             Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o             Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o             Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
 
Emerging growth company  o
 
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.  o

 

 
2.02.                                                                            Results of Operations and Financial Conditions.
 
On January 7, 2018, Exact Sciences Corporation (the “Company”) announced certain preliminary financial information for the quarter and full year ended December 31, 2017.  A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
 
7.01                                                                               Regulation FD Disclosure.
 
Attached hereto as Exhibit 99.2 is a PowerPoint presentation that the Company will present at the 2018 J.P. Morgan Healthcare Conference in San Francisco on January 9, 2018.
 
9.01.                                                                            Financial Statements and Exhibits.
 
Exhibits
 
The exhibits furnished as a part of this Current Report on Form 8-K are listed in the Exhibit Index attached hereto and incorporated herein by reference.
 
The information furnished in this Current Report on Form 8-K, including Exhibits 99.1 and 99.2 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
 
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EXHIBIT INDEX

Exhibit No	 	Exhibit Description	
99.1	 	Press release dated January 7, 2018, furnished herewith	
 	 	 	
99.2	 	PowerPoint presentation to be used by the Company on January 9, 2018, at the 2018 J.P. Morgan Healthcare Conference, furnished herewith	
 
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SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 	EXACT SCIENCES CORPORATION	
 	 	 	
Date: January 7, 2018	By:	/s/ Jeffrey T. Elliott	
 	 	Jeffrey T. Elliott	
 	 	Chief Financial Officer	
 
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Exhibit 99.1 
Contact:
Megan Jones
Exact Sciences Corp.
meganjones@exactsciences.com
608-535-8815
 
For Immediate Release
 
Exact Sciences to report $265.5-266.5 million in revenue, 168 percent growth for 2017
 
·                   Preliminary 2017 revenue between $265.5 million and $266.5 million, a year-over-year increase of 168 percent
·                   Approximately 571,000 Cologuard tests completed during 2017, a year-over-year increase of 134 percent
·                   11,000 new providers ordered Cologuard during the fourth quarter of 2017
 
MADISON, Wis., Jan. 7, 2018 - Exact Sciences Corp. (Nasdaq: EXAS) today announced that the company expects to report revenue between $86.9 million and $87.9 million for the fourth quarter ended Dec. 31, 2017, an increase of 148 percent from the same quarter of 2016. The company completed approximately 176,000 Cologuard tests during the fourth quarter of 2017, 115-percent growth from the same period of 2016.
 
For the full-year 2017, the company anticipates reporting revenue between $265.5 million and $266.5 million, a year-over-year increase of 168 percent. Completed Cologuard test volume during 2017 was approximately 571,000 tests, a 134-percent increase from 2016.
 
Nearly 11,000 health care providers ordered Cologuard for the first time during the fourth quarter ended Dec. 31, 2017.  The number of providers who have ordered Cologuard since its launch increased to nearly 102,000 during 2017.
 
“An increasing number of people are being screened for colon cancer with our accurate, non-invasive test,” said Kevin Conroy, chairman and CEO of Exact Sciences.  “As demand for Cologuard strengthens, we will continue to invest in our team, facilities and infrastructure to support the company’s long-term growth.”
 
Exact Sciences has not completed preparation of its financial statements for the fourth quarter or full year of 2017.  The revenue ranges presented for Q4 2017 and for the year ended December 31, 2017 are preliminary and unaudited and are thus inherently uncertain and subject to change as we complete our financial results for Q4 2017.  We are in the process of completing our customary year-end close and review procedures as of and for the year ended December 31, 2017, and there can be no assurance that our final results for this period will not differ from these estimates.  During the course of the preparation of our consolidated financial statements and related notes as of and for the year ended December 31, 2017, we or our independent registered public accountants may identify items that could cause our final reported results to be materially different from the preliminary financial estimates presented herein.
 
Exact Sciences plans to report 2017 financial results and provide revenue and Cologuard test volume guidance on its February 2018 earnings call.

 
About Cologuard
 
Cologuard was approved by the FDA in August 2014 and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society’s (2014) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average risk for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. False positives and false negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established. For more information about Cologuard, visit www.cologuardtest.com. Rx Only.
 
About Exact Sciences Corp.
 
Exact Sciences Corp. is a molecular diagnostics company focused on the early detection and prevention of the deadliest forms of cancer. The company has exclusive intellectual property protecting its non-invasive, molecular screening technology for the detection of colorectal cancer. For more information, please visit the company’s website at www.exactsciences.com, follow Exact Sciences on Twitter @ExactSciences or find Exact Sciences on Facebook.
 
Safe Harbor Statement
 
This news release 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 intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “could,” “seek,” “intend,” “plan,” “goal,” “estimate,” “anticipate” or other comparable terms. All statements other than statements of historical facts included in this news release regarding our strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding expected future operating results, anticipated results of our sales and marketing efforts, expectations concerning payer reimbursement and the anticipated results of our product development efforts. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in

 
circumstances that are difficult to predict and many of 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. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: our ability to successfully and profitably market our products and services; the acceptance of our products and services by patients and healthcare providers; our ability to meet demand for our products and services; the willingness of health insurance companies and other payers to cover Cologuard and reimburse us for our performance of the Cologuard test; the amount and nature of competition from other cancer screening products and services; the effects of the adoption, modification or repeal of any healthcare reform law, rule, order, interpretation or policy; the effects of changes in healthcare pricing, coverage and reimbursement; recommendations, guidelines and quality metrics issued by various organizations such as the U.S. Preventive Services Task Force, the American Cancer Society, and the National Committee for Quality Assurance regarding cancer screening or our products and services; our ability to successfully develop new products and services; our success establishing and maintaining collaborative, licensing and supplier arrangements; our ability to maintain regulatory approvals and comply with applicable regulations; and the other risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10-K and our subsequently filed Quarterly Report(s) on Form 10-Q. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Exhibit 99.2 
36th Annual J.P. Morgan Healthcare Conference 1 Kevin Conroy, Chairman and CEO January 9, 2018

This presentation 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 intended to be covered by the "safe harbor" created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "could," "seek," "intend," "plan," “goal,” "estimate," "anticipate" or other comparable terms. All statements other than statements of historical facts included in this presentation regarding our strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding expected future operating results, anticipated results of our sales and marketing efforts, expectations concerning payor reimbursement and the anticipated results of our product development efforts. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of 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. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: our ability to successfully and profitably market our products and services; the acceptance of our products and services by patients and healthcare providers; the willingness of health insurance companies and other payors to cover Cologuard and reimburse us for our performance of the Cologuard test; the amount and nature of competition from other cancer screening products and services; the effects of any healthcare reforms, including the Affordable Care Act, or changes in healthcare pricing, coverage and reimbursement; recommendations, guidelines and/or quality metrics issued by various organizations such as the U.S. Preventive Services Task Force, the American Cancer Society and the National Committee for Quality Assurance regarding cancer screening or our products and services; our ability to successfully develop new products and services; our success establishing and maintaining collaborative licensing and supplier arrangements; our ability to maintain regulatory approvals and comply with applicable regulations; and the other risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10-K and our subsequently filed Quarterly Report(s) on Form 10-Q. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Exact Sciences has not completed preparation of its financial statements for the fourth quarter or full year of 2017. The revenue ranges presented for Q4 2017 and for the year ended December 31, 2017 are preliminary and unaudited and are thus inherently uncertain and subject to change as we complete our financial results for Q4 2017. We are in the process of completing our customary year-end close and review procedures as of and for the year ended December 31, 2017, and there can be no assurance that our final results for this period will not differ from these estimates. During the course of the preparation of our consolidated financial statements and related notes as of and for the year ended December 31, 2017, we or our independent registered public accountants may identify items that could cause our final reported results to be materially different from the preliminary financial estimates presented herein. 2 Safe harbor statement

Our Vision Exact Sciences is committed to helping win the war on cancer through early detection. 3

4 Pathway to success in 2018 and future

Source: American Cancer Society, Cancer Facts & Figures 2018; all figures annual Colon cancer: America’s second deadliest cancer Source: American Cancer Society, Cancer Facts & Figures 2017; all figures annual new diagnoses 140,250 deaths 50,630 Annual Cancer Deaths 5 15,850 29,430 41,400 44,330 50,630 154,050 Esophageal Prostate Breast Pancreas Colorectal Lung

Sources: J Natl Cancer Inst. 2009; 101:1225-1227 (Itzkowitz) Gastro 1997;112:594-692 (Winawer) 6 “The most preventable, yet least prevented form of cancer” – Journal of the National Cancer Institute 10+ years Pre-cancerous polyp Cancer

7 Sources: CDC NHIS survey results as published in the CDC’s MMWR between 2006 and 2017 America’s stagnant colon cancer screening rate Actual colon cancer screening rates 2005 2008 2010 2013 2015 2018 50% 52% 59% 58% 62% 80% goal

8 Source: Imperiale TF et al., N Engl J Med (2014) *For stage I and II cancers; 87% specificity Cologuard: Addressing the colon cancer challenge 94% early stage cancer sensitivity* developed with Easy to use Non-invasive No preparation No sedation No time off work

9 Cologuard is changing lives every day “My positive Cologuard test last year led to a colonoscopy that revealed stage I cancer. I’m grateful to now be active and healthy as I travel the country with my husband.” - Brenda Savannah, GA

*Estimates based on DeeP-C pivotal trial findings: Imperiale TF et al., N Engl J Med (2014) 10 Impact of Cologuard since launch People screened 923,000 ~4,300 Early-stage cancers detected *

11 Strong Cologuard revenue growth 2015 2016 Quarterly Cologuard revenue ($ Millions) 2017 * *Midpoint of preliminary, unaudited fourth quarter revenue range $1.5 $4.3 $8.1 $12.6 $14.4 $14.8 $21.2 $28.1 $35.2 $48.4 $57.6 $72.6 $87.4

12 Cologuard demand continues to fuel volume growth 2015 2016 Quarterly Cologuard tests completed 2017 4,000 11,000 21,000 34,000 38,000 40,000 54,000 68,000 82,000 100,000 135,000 161,000 176,000

Exact Sciences Laboratories data, Patient Satisfaction Survey, May-Dec 2017; n = 3,772 13 Increasing America’s screening population Screening history of Cologuard users 39% screened with colonoscopy 13% screened only with FIT/FOBT 48% never screened before

14 Cologuard’s growing provider penetration Total ordering providers 84K Primary Care Providers 4Q15 4Q17 4Q16 4Q14 6.5K Gastroenterologists 2.8K OBGYN’s 8.7K Other providers

15 Exact Sciences’ unique dataset addresses critical needs Improve quality measures and outcomes Payers Improve quality measures and reporting capabilities Providers Increase compliance and repeat screening Patients

16 A multi-billion dollar U.S. market opportunity *85 million average-risk, asymptomatic people ages 50-85, **Assumes revenue per test of $500-525 and 3-year interval for Cologuard, ***(176,000 completed tests * 4 to annualize * 3 to account for interval) / 85M 85M+ 2.5% Potential U.S. screening market for Cologuard* >$14B Total Addressable Market** market share***

17 Clinical value of Cologuard: comparing numbers needed to screen/treat 166 to find 1 colorectal cancer* 217 to prevent 1 heart attack*** Statins *Imperiale TF et al., N Engl J Med (2014) **Hendrick R et al., AJR (2012) – for ages 40-49 ***Chou R, Dana T, Blazina I, Daeges M, Jeanne TL., JAMA (2016) Mammography 746 to prevent 1 breast cancer-related death**

18 Building infrastructure for long-term growth Lab Operations Sales Teams Customer Care & Billing Medical Affairs Clinical & Regulatory Health Systems

19 Investing in Exact Sciences’ nationwide sales force Primary care sales force Educate physicians & office staff and improve repeat ordering of Cologuard Extend reach of sales force coverage and new physician outreach and pull through Inside sales force ~250 ~100 350 200 2017 2018 (est.)

20 Cologuard’s compliance rate is derived from the number of completed tests reported divided by the number of collection kits shipped to patients during the 12-month period ending 60 days prior to Dec. 31, 2017, excluding program orders Driving patient compliance with colon cancer screening 65% Patient compliance Welcome call 24/7 patient support line Cologuard delivered to home Reminder calls Reminder letter

21 Sources: ZS survey conducted for Exact Sciences Aug-Sep 2017, n=211 Exact Sciences Laboratories patient satisfaction survey Jan-Dec 2017, n = 5,699 Strong customer satisfaction with Cologuard Providers’ expectations met or exceeded Patients rated Cologuard experience very positive 88% 98%

22 Broad marketing strategy increasing Cologuard awareness National TV campaign Social & digital media National partnerships Feb 28 – Mar 4 National celebrity spokesperson TBA

23 Investing in facilities and additional capacity ~2M Expected annual capacity by mid-2019 >2.5M Expected annual capacity by mid-2018 145 Badger Road 1 Exact Lane Expected total capacity of more than 4.5 million tests by mid-2019

24 Investing in future of Cologuard and pipeline Acquired rights to methylation marker used in Cologuard Acquired to augment and strengthen IT capabilities Acquired portfolio of protein biomarkers to complement pipeline

Source: World Health Organization and Centers for Disease Control and Prevention 25 Cancer is the 2nd leading cause of death globally Expected 70% increase in new cancer cases globally within 20 years 1.7M new cancer cases 600k deaths 14M new cancer cases 8.8M deaths

26 Cologuard success helping to reimagine cancer diagnostics Exact Sciences has pieces in place to be successful in liquid biopsy PEOPLE PLATFORM MARKET Collaboration with Mayo Clinic Exact Sciences’ proven experience Multi-marker approach, proprietary technology, & platform Time, cost, & accuracy advantages Fast-growing liquid biopsy market Targeting top 10 deadliest cancers

27 Unique collaboration between Exact Sciences and Mayo Clinic

28 *Liquid biopsy study results only Advantages of Exact Sciences’ approach Highly sensitive and specific 3 study results with 90%+ sensitivity and specificity* Low cost Tens of dollars in reagents instead of hundreds Quick turn around time Hours instead of days Universal platform Leveraging Cologuard platform for liquid biopsy

Source: Analyst estimates 29 Liquid biopsy a growth area for cancer diagnostics Exact Sciences focusing on early detection & recurrence Projected liquid biopsy market >$13B $200M Screening Minimum residual disease Recurrence monitoring Response monitoring Targeted therapy selection Clinical applications Diagnostic aid Response profiling 2015 2030

30 Preliminary fourth-quarter and full-year 2017 results Q4 2017 Revenue (millions) $86.9 - $87.9 $265.5 - $266.5 Y/Y growth % 148% 168% Completed Tests 176,000 571,000 Y/Y growth % 115% 134% FY 2017 Unaudited financial results

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