Corporate Presentation
September 2015
Safe Harbor statement Certain statements made in this presentation contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended that are intended to be covered by the "safe harbor" created by those sections. Forward-looking statements can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "could," "seek," "intend," "plan," "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 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; the acceptance of our products by patients and health care providers; the amount and nature of competition from other cancer screening products and procedures; our ability to maintain regulatory approvals and comply with applicable regulations; our success establishing and maintaining collaborative and licensing arrangements; our ability to successfully develop new products; and the other risks and uncertainties described in the Risk Factors and in the 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. We have filed a registration statement, including a prospectus, with the U.S. Securities and Exchange Commission (the “SEC”) for the offering to which this communication relates. Before you invest, you should read the prospectus in that registration statement and other documents the issuer has filed with the SEC for more complete information about the issuer and this offering. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, the issuer, any underwriter, or any dealer participating in the offering will arrange to send you the prospectus if you request it by calling 877-547-6340 or 800-792-2413. 2
To work with patients, payers and providers to help play a role in the
eradication of colorectal cancer
OUR FIRST MISSION
3
Source: ACS Cancer Facts & Figures 2015; all figures annual
Colon cancer: America’s second most lethal cancer
new diagnoses in 2015
15,590 27,540
40,560 40,730 [VALUE]
158,040
Esophageal Prostate Pancreas Breast Colorectal Lung
Annual US cancer mortality
132,700
deaths in 2015 49,700
4
132,700 new diagnoses in US
5 Sources: J Natl Cancer Inst. 2009; 101:1225-1227 (Itzkowitz) N Engl J Med 2012;366:687-96 (Zauber); Gastro 1997;112:594-692 (Winawer)
Why is colon cancer the “Most preventable, yet least prevented form of cancer”?
Pre-cancerous polyp Four stages of colon cancer
10+
years
6 Source: Winawer SJ et al. N Engl J Med. 1993; 329(27):1977-1981 Zauber AG et al. N Engl J Med. 2012; 366(8): 687-696.
Colorectal cancer screening works
Incidence reduced by
90% over 7 years versus expected outcome
Mortality reduced by
60% over 22 years versus
national average
7 Source: SEER 18 2004-2010
Detecting colorectal cancer early is important
9 out of 10 Survive 5 years if
Diagnosed in Stages I or II
1 out of 10 Survive 5 years if
Diagnosed in Stage IV
Source: CDC MMWR 2013; 64(17);464-468 (Sabatino)
But many Americans aren’t getting screened
42%
of Americans not current on colon cancer screening
8
Source: J Natl Cancer Inst. 2011; 103:1-12 (Mariotto)
Rising cost of colorectal cancer treatment
2010 2015 2020
Projected annual treatment costs
in 2020
$20B
$14B
9
Cologuard®: Foundation to our success
§ FDA-approved & Medicare-covered
§ Developed in collaboration with Mayo Clinic
§ New England Journal of Medicine results:
• 92% cancer sensitivity (all stages)
• 69% high grade dysplasia sensitivity
• 87% specificity
• 94% sensitivity for stages I to II cancer
§ Included in American Cancer Society guidelines
Source: American Cancer Society Cancer Facts & Figures 2015. Atlanta: American Cancer Society; 2015. 10
160
High-quality sales force driving Cologuard® demand
200
Sales Team on June 1
Creating a results-driven field force
§ Strategically aligned co-promotion partner
§ Average 10-years sales experience
§ Focused on high-value physicians § Real-time data guides strategy
11
12
World-class lab delivering results
Capable of processing more than 1 million Cologuard® tests per year
Cologuard’s® strong demand and launch trajectory
4K 11K
21K
>32K
Q4 Q1 Q2 Q3
13
Completed Cologuard Tests
Guidance
80,000 Cologuard orders through Q2
Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun
Physicians ordering Cologuard® is rapidly expanding
14,700 ordering physicians
Adding ~500 new physicians weekly
14
Sources: US Census, “Health Insurance Coverage Status and Type of Coverage by Selected Characteristics: 2013” US Census, “State Characteristics: Vintage 2013” AIS Directory of Health Plans: 2015 Exact Sciences internal analysis *market share for individuals ages 50-64
Reimbursement landscape for insured patients 50+ years of age
Medicare 46%
Commercial Coverage for Cologuard®
9%*
Pursuing Coverage
45%
15
Growth strategy to expand coverage and contracting
Quality of Care
Cost Savings
Member Satisfaction
Compelling payer value proposition
16
NEJM publication – 92% sensitive, Medicare NCD
Easy, non-invasive test; >70% patient compliance
Cologuard® delivering positive budget impact
USPSTF guidelines promote Cologuard® use, expand coverage
§ Draft guidelines expected 2015 § Final rating expected 2016
17
Included in HEDIS &
STARS quality metrics
Commercial insurers follow
USPSTF Strong incentives for providers and payers to promote
Cologuard
18 *Patient compliance rate: number of valid test results reported divided by the number of collection kits shipped to patients 60 or more days prior to June 30, 2015.
Comprehensive screening program drives compliance
73% Patient Compliance*
Physician orders
Customer outreach
Cologuard completed
Physician provided result
Never screened before Screened with colonscopy only
Screened with colonscopy and FIT/
FOBT
Screened with FIT/FOBT only
36% 36%
Source: Exact Sciences Laboratories LLC data (unpublished), n = 2,997
8% 20%
19
Screening history of Cologuard® users Increasing America’s screening population
v Exact Sciences’ Pipeline
20
Exact Sciences is committed to helping win the war on cancer through
early detection
OUR VISION
21
Exact Sciences is well-positioned to develop a blood-based lung cancer test
Scientific Capabilities Robust chemistry automation platform
Ability to Collaborate Successful collaboration with Mayo Clinic
FDA/CMS Experience Pioneered parallel review with Cologuard®
Clinical Trial Execution 10,000-patient DeeP-C clinical trial
Commercial Capability 200-person primary care sales force
22
221,000 new diagnoses in US
Source: Am Cancer Soc. Cancer Facts & Figures 2015. Atlanta: American Cancer Society; 2015.
Lung Cancer: America’s leading cancer killer
15,590 27,540
40,560 40,730 [VALUE]
158,040
Esophageal Prostate Pancreas Breast Colorectal Lung
Annual US cancer mortality
Lung
23
Low Dose CT (LDCT) screening faces enormous challenges and costs
Limitations to LDCT
Sensitivity 94%
Positives nodules that are benign
96%
Specificity 73%
Often harmful and invasive
~$3,600 per positive result
Radiation exposure
Impact of follow-up
Approved by regulators
24 Sources: N Engl J Med. 2013 May 23;368(21):1980-91. doi: 10.1056/NEJMoa1209120 (National Lung Screening Trial Research Team)
Bringing blood-based tests to large populations
Screening diagnostic for high-risk smokers and
former smokers
Nodules discovered via CT screening or
incidentally
US Patient Population
4M
10M
25
Monitoring US population for nodules will compound annually to reach more than 20M
• ~4M patients with nodules added annually
= 4M
0
3
6
9
12
15
18
21
24
1 7 Years from Launch
Popu
latio
n (M
)
High follow-up, high positive LDCT attrition
26
27
Financial performance remains strong
Q2 revenues $8.1 million
Q2 operating expense $42.4 million
Q2 end cash balance $210.8 million
July 20, 2015 financial offering $175 million