exact sciences corporate presentation: june 2016

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v Corporate Presentation June 2016 updated

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Page 1: Exact Sciences Corporate Presentation: June 2016

vCorporate Presentation

June 2016 – updated

Page 2: Exact Sciences Corporate Presentation: June 2016

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 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 2016 guidance, expected numbers of completed and

reported Cologuard tests, anticipated patient compliance rates, 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 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 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 and licensing arrangements; our ability to maintain regulatory

approvals and comply with applicable regulations; the impact of our nationwide television advertising campaign; anticipated contracts with Anthem and

other health insurance companies; 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.

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Page 3: Exact Sciences Corporate Presentation: June 2016

OUR MISSION

To partner with healthcare providers,

payers, patients & advocacy groups to

help eradicate colon cancer

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Page 4: Exact Sciences Corporate Presentation: June 2016

Source: American Cancer Society, Cancer Facts & Figures 2016; all figures annual

Colon cancer: America’s second deadliest cancer

new diagnoses in 2015

15,690

26,120

41,780 40,890

49,190

158,080

Esophageal Prostate Pancreas Breast Colorectal Lung

Annual cancer deaths

132,700

deaths in 2015

49,700

134,490new diagnoses

49,190deaths

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Page 5: Exact Sciences Corporate Presentation: June 2016

10+ years

Sources: J Natl Cancer Inst. 2009; 101:1225-1227 (Itzkowitz)

Gastro 1997;112:594-692 (Winawer)

Why is colon cancer the “Most preventable, yet

least prevented form of cancer”?

Pre-cancerous polypFour stages of

colon cancer

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Page 6: Exact Sciences Corporate Presentation: June 2016

Sources: SEER 18 2004-2010

American Cancer Society, Cancer Facts & Figures 2016; all figures annual

Detecting colorectal cancer early is critical

9 out of 10

survive 5 years

Diagnosed in Stages I or II Diagnosed in Stage IV

1 out of 10

survive 5 years

60% of patients are diagnosed in stages III-IV

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Page 7: Exact Sciences Corporate Presentation: June 2016

America’s stagnant colon cancer screening rate

50%52%

59% 58%

80% 80%

2005 2008 2010 2013 2018 2020

Source: CDC NHIS survey results as published in the CDC’s MMWR between 2006 and 20157

Goals

Page 8: Exact Sciences Corporate Presentation: June 2016

Three easy steps to using Cologuard

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Page 9: Exact Sciences Corporate Presentation: June 2016

Cologuard: Addressing the colon cancer challenge

Stool DNA test: 11 biomarkers (10 DNA & 1 protein)

FDA-approved & covered by MedicareList price - $649; Medicare rate - $509

Results of 10,000-patient prospective trial published in New England Journal of Medicine

Included in American Cancer Society guidelines & final USPSTF recommendations at 3 year interval

Source: Imperiale TF et al., N Engl J Med (2014)

Developed with

Mayo Clinic

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Page 10: Exact Sciences Corporate Presentation: June 2016

10Source: US Preventive Services Task Force (2016). Screening for colorectal cancer: US preventive

services task force recommendation statement. JAMA. Epub ahead of print. doi:10.1001/jama.2016.5989

Cologuard included in final

2016 USPSTF recommendations

• Final recommendations removes “alternative” category and

includes 3-year interval analysis

• Task Force eliminates ambiguity and hierarchy created in

draft recommendations

• Additional scientific literature and public comments

shaped final recommendations

• Cologuard should receive benefits given to A-rated

preventive services under the Affordable Care Act

Page 11: Exact Sciences Corporate Presentation: June 2016

A multi-billion dollar U.S. market opportunity

U.S. market opportunity

for Cologuard

$4B

Potential 80M-patient

U.S. screening market*

***

*80 million average-risk, asymptomatic people ages 50-85

**Assumes unscreened decreases from 42% to 30%

***Assumes 24M people screened with Cologuard every three years with ASP of $500 11

Page 12: Exact Sciences Corporate Presentation: June 2016

Sources:

1 Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med 2014; 370: 1287-1297.

2 Redwood DG, Asay ED, Blake ID, et al . Stool DNA Testing for Screening Detection of Colorectal Neoplasia in Alaska Native People. Mayo Clin Proc 2016; 91: 61-70.

3 Berger BM, Schroy PC, 3rd, Dinh TA. Screening for Colorectal Cancer Using a Multitarget Stool DNA Test: Modeling the Effect of the Inter-test Interval on Clinical Effectiveness. Clin

Colorectal Cancer 2015.Epub ahead of print.

4 Berger BM, Parton M, Levin B, USPSTF Colorectal Cancer Screening Guidelines: An Extended Look at Multi-Year Interval Testing, Am J Managed Care 2016 22(2):e77 – e81.

5 Cologuard’s patient compliance rate is derived from the number of valid tests reported divided by the number of

collection kits shipped to patients during the 12-month period ending 60 days prior to March 31, 2016..

6 Abola MV, Fennimore TF, Chen MM, et al. DNA-based versus colonoscopy-based colorectal cancer screening: patient perceptions and preferences. Fam Med Commun H 2015; 3: 2-8.

Comprehensive case for Cologuard

Cancer detection >90% in two studies1, 2

Superior performance

Versus other screening methods3

Cost-effective

Analysis of independent modeling4

3-year interval

69% compliance with Cologuard kits shipped5

Compliance program

75% of patients consider more suitable than colonoscopy

84% of patients would repeat Cologuard, if recommended6

Patient

satisfaction

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Page 13: Exact Sciences Corporate Presentation: June 2016

Cancer

detection92%

(60/65)

Precancer

detection42%

(321/757)

Specificity(clean colon*)

90%(4002/4457)

*Clean colons have no need for a biopsy

Sources: Imperiale TF et al., N Engl J Med (2014)

Redwood DG, Asay ED, Blake ID, et al . Stool DNA Testing for Screening Detection of Colorectal Neoplasia in Alaska Native People. Mayo Clin Proc 2016; 91: 61-70.

Cologuard’s performance confirmed in recent study

March 2014 October 2015

41%(31/76)

100%(10/10)

93%(296/318)

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Page 14: Exact Sciences Corporate Presentation: June 2016

1FDA Advisory Panel material, Epigenomics AG PMA P130001, March 26, 20142Company website3Company news release dated Feb. 17, 20164Stages I-II; does not report Stage I only55-assay panel

Blood-based colon cancer tests not currently viable

(clean colon)

Low sensitivity for early-stage cancer & high false positive rate

*Not prospective,

not average risk &

not peer-reviewed

Interval SensitivityAll stages

Sensitivity Stage I

Specificity Lifetime

False+

3 years 92% 90% 90% 1.2

EpigenomicsEpi proColon

(Septin 9)1

1 year 68% 41% 79% 7.4

Applied

Proteomics*SimpliPro2

1 year 81% 75%4 78% 7.7

VolitionRx*NuQ3 1 year 81% 75%5 78% 7.7

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Page 15: Exact Sciences Corporate Presentation: June 2016

Source: American Journal of Managed Care, February 2016

Virtually no adherence to annual colon cancer screening

3 of 1,000 continuously-insured people adhere to FIT / FOBT recommendations

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Page 16: Exact Sciences Corporate Presentation: June 2016

$11,313

per QALYs

$15,500

per QALYs

$30,000

per QALYs

Modeling supports Cologuard as cost-effective

3 years

cervical

cancer

3 years 2 years

breast

cancer

QALYs: Quality adjusted life years saved

Source: Berger BM, Schroy PC, 3rd, Dinh TA. Screening for Colorectal Cancer Using a Multitarget Stool DNA Test: Modeling the

Effect of the Intertest Interval on Clinical Effectiveness. Clin Colorectal Cancer 2015.Epub ahead of print.

Cologuard compares favorably with established screening strategies

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Page 17: Exact Sciences Corporate Presentation: June 2016

Zauber A, et. al. “Evaluating the Benefits and Harms of Colorectal

Cancer Screening Strategies: A Collaborative Modeling Approach.”

AHRQ (2015). See Appendix Tables 3(a) – 10(c).

CISNET modeling highlights Cologuard 3-year has

superior benefits-to-harms ratio

Complications per thousand

Life years gained per thousand

Deaths averted per thousand

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Page 18: Exact Sciences Corporate Presentation: June 2016

Cologuard increases patient compliance

13

USMD study highlights opportunity to expand screening & detect curable-stage cancer

American Association of Cancer Research Annual meeting 2016, New Orleans LA USA, LB-296,

Proceedings of the American Association of Cancer Research, in press

Non-compliant

Medicare

patients

393Cancers in

curable stage;

21 advanced

adenoma

4Cologuard

compliance

88%

Page 19: Exact Sciences Corporate Presentation: June 2016

19Source: Mayo Clinic poster presentation Su1044, Digestive Disease Week 2016

Knowledge of positive Cologuard

improves Colonoscopy performance

2xPolyps

discovered46% more time spent

on colonoscopy

Mayo Clinic study compares results of unblinded, blinded colonoscopies

Page 20: Exact Sciences Corporate Presentation: June 2016

Increasing America’s screening population

49% screened with

colonoscopy

Screening history of Cologuard users

42% never

screened before

Source: Colorectal Cancer Screening with Multi-target stool DNA-based Testing Previous Screening History of the Initial Patient Cohort, poster presented at American College of

Gastroenterology's Annual Scientific Meeting (ACG 2015), Oct. 16-21, 2015; ages 50-74

9% screened only

with FIT/FOBT

4 in 10 Cologuard users never previously screened

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Page 21: Exact Sciences Corporate Presentation: June 2016

Only 24/7/365 nationwide colon cancer screening

network drives compliance

69%

Patient

compliance*

Cologuard’s patient compliance rate is derived from the number of valid tests reported divided by the number of

collection kits shipped to patients during the 12-month period ending 60 days prior to March 31, 2016. 21

Page 22: Exact Sciences Corporate Presentation: June 2016

Three-pronged commercial strategy

Physicians

Primary care

sales force

National TV campaign

Digital marketing

Payers

Clinical & health

publications

Market access

team

GuidelinesPatients

Public relations

Multi-channel

direct to consumer

National TV campaign

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Page 23: Exact Sciences Corporate Presentation: June 2016

Cologuard’s growing physician penetration

*IMS data based on heart drug prescriptions

August

2014

March

2016

4,100

8,300

14,700

21,000

27,000

200,000 potential Cologuard prescribers*

23

32,000

Q1 2015 Q2 2015 Q3 2015 Q4 2015 Q1 2016

Page 24: Exact Sciences Corporate Presentation: June 2016

Strong customer satisfaction with Cologuard

Physicians

expectations

met or exceeded 98%

Patients rated

Cologuard experience

very positive88%Sources: ZS survey conducted for Exact Sciences, n=300

Exact Sciences Laboratories patient satisfaction survey data is cumulative; n = 2,79924

Page 25: Exact Sciences Corporate Presentation: June 2016

Source: Imperiale TF et al., N Engl J Med (2014)

Exact Sciences internal estimates based upon prevalence and detection rates from DeeP-C study

2015 results demonstrate Cologuard’s impact

Cancers potentially detected

104,000completed

Cologuard tests

600cancers

500early-stage

cancers

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Page 26: Exact Sciences Corporate Presentation: June 2016

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Targeted TV ads impacting ordering & adoption

Cologuard

orders +50%

New

physician

adoption +100%

Average boost in

test vs. control markets

Ad available at CologuardTest.com

Percentage point growth compares 9-week average between TV test and control markets.

Tested in 5 markets between January – March 2016: Atlanta, Baltimore, Milwaukee/Madison, Sacramento & Tampa Bay

Page 27: Exact Sciences Corporate Presentation: June 2016

Quality

of care

Strategy to advance coverage to contracting

Cost

savings

Member

satisfaction

Value proposition for payers

NEJM publication

shows 92% sensitivity

Easy, non-invasive test;

69% patient compliance

Cologuard delivering

positive budget impact$27

Page 28: Exact Sciences Corporate Presentation: June 2016

46% 46%

8%

Source: US Census 2013 and AIS Directory of Health Plans: 2015; ages 50-8528

Medicare Commercial

Military &

Medicaid

Breakdown of current U.S. insurance market ~80M average-risk people age 50-85

Page 29: Exact Sciences Corporate Presentation: June 2016

Cologuard covered by Medicare

69%

31%

Medicare

Advantage

Traditional

fee-for-service

Medicare

Source: US Census 2013 and AIS Directory of Health Plans: 2015; ages 50-85

More than 37M average-risk Medicare patients ages 50-85

29

Medicare Advantage

plans are required to

treat Cologuard as an

in-network benefit for

cost-sharing purposes

Page 30: Exact Sciences Corporate Presentation: June 2016

75% 25%

Pursuing Coverage Covered

Source: US Census 2013 and AIS Directory of Health Plans: 2015; ages 50-85

Achieving 25% commercial coverage for Cologuard

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58 million lives covered by

commercial plans, including:

• Anthem

• Horizon BCBS

• BCBS Massachusetts

• CareFirst BCBS

• Independence Blue Cross

• BCBS Louisiana

• Excellus BCBS

• Harvard Pilgrim Healthcare

• Tufts Health Plan

• Government Employees

Health Association

• Priority Health

• Johns Hopkins Health Plan

• among other plans

Page 31: Exact Sciences Corporate Presentation: June 2016

Insures 37.6 million people nationwide

Second largest insurer in U.S.

Anthem enters into agreements by network/region

• Currently contracted: CA, VA and GA

• Latest contracts completed as of June 1: IN, KY, MO, OH and WI

• ~70% of Anthem’s members live in these regions

Sources: Estimate based on US Census data and enrollees

AIS Directory of Health Plans: 2015

Anthem contracting progressing quickly

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Page 32: Exact Sciences Corporate Presentation: June 2016

100%

32

Insurance coverage drives order growth

Growth rates measured from March 29, 2015 to March 26, 2016

Percentage-point increase in

order growth in 10 states with

highest insurance coverage,

compared to rest of country

Page 33: Exact Sciences Corporate Presentation: June 2016

Guidance

2015 2016

Projecting $90-100M revenue in 2016

104,000

$39.4M

>240,000

$90-100M

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Page 34: Exact Sciences Corporate Presentation: June 2016

First-Quarter 2016 financial results

Revenues

Operating expenses

Cash utilization

Cash balance

34

First Quarter

2016

$14.8 million

$53.7 million

$44.3 million

$262.6 million

Page 35: Exact Sciences Corporate Presentation: June 2016

80M-person addressable marketLow satisfaction, compliance with

historically-available options

Strong intellectual property protectionCostly 5-10 year product development,

FDA and CMS pathway to approval

Compliance engine3-year adherence drives recurring revenue

Cost and satisfactionNear-term savings; increasing screening rates

High product

satisfaction

Patients and physicians want CologuardMet or exceeded expectations of 98% of physicians;

88% of patients rated experience very positive

Value to payers

Only national network

for CRC screening

High barrier to entry

Large market

opportunity

Cologuard: An opportunity for long-term growth

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Page 36: Exact Sciences Corporate Presentation: June 2016

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