december 2016 exas corporate presentation final 12.12

36
v Corporate Presentation December 2016

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vCorporate Presentation

December 2016

Safe harbor statement

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," "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.

2

OUR MISSION

To partner with healthcare providers,

payers, patients & advocacy groups to

help eradicate colon cancer

3

Eradicating Colon Cancer:

Challenges & Opportunity

4

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

41,78040,89049,190

158,080

Esophageal Prostate Breast Pancreas Colorectal Lung

Annual cancer deaths

132,700

deaths in 2015

49,700

134,490new diagnoses

49,190deaths

5

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

6

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

7

Rx Only

50%52%

59% 58%

80% 80%

2005 2008 2010 2013 2018 2020

8

95% of screened patients

underwent colonoscopy2

Sources: 1. CDC NHIS survey results as published in the CDC’s MMWR between 2006 and 2015

2. CDC BFRSS survey as published in MMWR (2013)

Care Gapcervical (81%) &

breast cancer (73%)

achieve higher

screening rates1

Actual colon cancer screening rate Goal screening rate

America’s stagnant colon cancer screening rate

Cologuard addresses 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 leading cancer screening guidelines at 3 year interval:

• U.S. Preventive Services Task Force (2016) • National Comprehensive Cancer Network (2016)• American Cancer Society (2014)

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

Developed with

Mayo Clinic

9

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 multiple studies

March 2014 October 2015

41%(31/76)

100%(10/10)

93%(296/318)

10

Cologuard:

Becoming Standard of Care

11

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

****Assumes 30% market share for Cologuard

*****Assumes 40% market share for colonoscopy & FOBT

*****

****

12

Cologuard becoming standard of care

Patient & physician demand increases with coverage & guideline inclusion

Medicare

Star Ratings*

* CMS Star Ratings are guided by HEDIS quality measures.

Cologuard's inclusion in the Star Ratings is expected in 2017.

Regulatory & coverage Guideline inclusion Quality measures

13

Rx Only 14Sources: USPSTF, “Final Recommendation Statement, Colorectal Cancer: Screening (June 2016)” JAMA (2016)

Screening Method Frequency

Stool-Based Tests

gFOBT Every year

FIT Every year

FIT-DNA Every 1 or 3 y

Direct Visualization Tests

Colonoscopy Every 10 y

CT colonography Every 5 y

Flexible sigmoidoscopy Every 5 y

Flexible sigmoidoscopy

with FIT

Flexible sigmoidoscopy every 10 y

plus FIT every year

Cologuard included in USPSTF recommendations

Rx Only 15

2016 HEDIS performance audit will use HEDIS 2017 rules.

Screening credit given for patients screened using Cologuard in 2014, 2015 or 2016.

HEDIS

HEDIS 2017 measure for

colon cancer screening

Fecal occult blood test during the measurement year.

Flexible sigmoidoscopy during the measurement year or four years prior.

Colonoscopy during the measurement year or nine years prior.

CT colonography during the measurement year or the four years prior

FIT-DNA test (FIT-DNA Value Set) during the

measurement year or the two years prior to

the measurement year

Source: NCQA, HEDIS 2017 Volume 2 Technical Update. Published October 3, 2016

Cologuard drives quality credit

Source: Dale, CR et al., N Engl J Med (2016)

Quality measures increase colon cancer screening

>50% increase in screening after physicians were compensated on quality measures

16

17Sources: CMS 2017 Star Ratings Fact Sheet

Kaiser Health News, March 1, 2016

Quality measures impacting Medicare Advantage plansHealth plans aiming for ≥ 4 Star Rating to earn 5% bonus payments

12

67

10797

67

14

Star Rating

54.543.532.5

2017 Medicare Advantage Plans

Ratings by Star Level

Key thresholds in Star Ratings:

5 Star Ratings: year-round open

enrollment

≥ 4.0 Star Rating: ~$500 per

member and top member

rebate payments

Strong customer satisfaction with Cologuard

Physicians’

expectations

met or exceeded 98%

Patients rated

Cologuard experience

very positive90%Sources: ZS survey conducted for Exact Sciences, n=300

Exact Sciences Laboratories patient satisfaction survey data is cumulative; n = 2,79918

Cologuard: Increasing America’s screening population

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

49% screened with

colonoscopy

42% never

screened before9% screened only

with FIT/FOBT

Screening history of

Cologuard users

19

Rx Only 20

Patients and physicians supported by proactive outreach and 24/7 care center

20

OrderCologuard

delivered

Welcome

call & letter

Audit of patient’s

age & interval

Compliance

call 1

Compliance

call 2

Compliance

letter

Cologuard

returned

Week 1 Week 4

Proactive outreach from Exact Sciences

Week 2

Increasing compliance with a screening program

Rx Only 21

Exact Sciences’ compliance program increases screening

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 trailing 12-month period.

Sources: 1. Exact Sciences Q2 2016 Earnings Call

2. Exact Sciences internal calculation based on call center data

28%

34%

7% 67%

Returned with nocompliance calls

Returned with 1compliance call

Returned with 2compliance calls

Overall compliance rate

Percentage of compliant patients

Offering Cologuard increases patient complianceUSMD 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%

22

A Strategy to Drive

Cologuard Adoption

23

Three-pronged commercial strategy

Physicians

Primary care

sales force

National TV campaign

Digital marketing

Payers Clinical & health

publications

Market access

team

Guideline

inclusion

Patients

Public relations

Digital direct to

consumer

National TV campaign

24

Cologuard’s growing provider penetration

4,100

8,300

14,700

21,000

27,000

32,000

Q1 Q2 Q3 Q4 Q1

41,000

August

2014

Sept

2016

Q2

25

50,000

Q3

National TV campaign increasing ordering & adoption

26

Digital advertising complements national TV campaign

27

Increasing CologuardTest.com visits, order form downloads and patient guide downloads

46% 46%

8%

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

Medicare Commercial

Military &

Medicaid

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

28

Medical coverage accelerating following

Cologuard’s inclusion in USPSTF recommendations

-

20

40

60

80

100

120

140

160

Mill

ion

s o

f be

ne

ficia

ries

153M total

USPSTF

Medicare

Anthem

HCSC

BCBS

MA

IBC BCBS

LA

Health Net

Source: US Census data, AIS Directory of Health Plans: 2016

29

Cigna &

TRICARE

CareFirst

Humana

Strategy to advance insurance coverage

Value proposition for payers

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

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 June 30, 2016. 30

Quality

of care

Economic

value

Member

satisfaction

Close the care gap with a

colon cancer screening test that’s

92% sensitive and 87% specific

High compliance with Cologuard driven by

patient satisfaction and customer service

Cologuard can help increase quality rating and is

cost saving to health plans $

Cologuard growth accelerating in 2016

4,00011,000

21,000

34,00038,000 40,000

54,000

68,000

Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3

2014 2015 2016

~78,000guidance

Q4

Cologuard tests completed31

Guidance

2015 2016

Projecting $93-95M revenue in 2016

104,000

$39.4M

~240,000

$93-95M

32

Source: Company data; Wells Fargo Securities, LLC

Cologuard’s strong launch trajectory

BRACAnalysis (MYGN)

Prolaris (MYGN)

Oncotype Dx Prostate (GHDX)

Oncotype Dx Breast/Colon (GHDX)

FoundationOne (FMI)

MaterniT21 (SQNM)

Panorama (NTRA)

Afirma (VCYT)

VectraDA (MYGN)

Assurex (MYGN)

0K

10K

20K

30K

40K

50K

60K

70K

80K

90K

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19

Launch year

Qu

art

erl

y t

est

vo

lum

e

33

Exact Sciences

(EXAS)

34

Foundation built on key milestones

Cologuard developed with Mayo Clinic 2009 – 2010 ✔

10,000-patient DeeP-C clinical trial 2011 – 2012 ✔

DeeP-C results published in NEJM March 2014 ✔

FDA approval August 2014 ✔

Medicare coverage and pricing October 2014 ✔

Inclusion in key guidelines 2014 – 2016 ✔

Inclusion in HEDIS quality measures October 2016 ✔

Buildout of commercial infrastructure 2013 – present ✔

Broad commercial insurance coverage Ongoing

Broad provider access to electronic ordering Ongoing

Third-quarter financial results

Revenues

Operating expenses

Cash utilization

Cash balance

35

Third Quarter

2016

$28.1 million

$54.2 million

$30.5 million

$337.8 million

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