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vCorporate Presentation
September 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.
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
41,78040,890
49,190
158,080
Esophageal Prostate Breast Pancreas Colorectal Lung
Annual cancer deaths
132,700
deaths in 2015
49,700
134,490
new diagnoses
49,190
deaths
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 polyp
Four 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
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 2015
Goals
8
Cologuard addresses the colon cancer challenge
 Stool DNA test: 11 biomarkers (10 DNA & 1 protein)
 FDA-approved & covered by Medicare
List 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
detection
92%
(60/65)
Precancer
detection
42%
(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
Three easy steps to using Cologuard: Get, Go, Gone
11
Cologuard:
Becoming Standard of Care
12
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
*****
****
13
Cologuard becoming standard of care
Patient & physician demand increases with coverage & guideline inclusion
Medicare
Star Ratings**
*Pending publication of HEDIS 2017 quality measures, expected October 2016
** Medicare Advantage Star Measures are guided by HEDIS quality measures
Regulatory & coverage Guideline inclusion Quality measures*
14
Cologuard is “A” graded in current
USPSTF colon cancer screening recommendations
Sources: USPSTF, Final Recommendation Statement, Colorectal Cancer: Screening (June 2016)
JAMA. 2016;315(23):2564-2575. doi:10.1001/jama.2016.5989
15
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 2016 Star Ratings Fact Sheet
Quality measures impacting Medicare Advantage plans
Health plans aiming for ≥ 4 Star Rating to earn 5% bonus payments
12
66
112
102
65
12
Star Rating
54.543.532.5
2016 Medicare Advantage Plans
Ratings by Star Level
Key thresholds in
Star Ratings:
5 Star Rating: year-
round open enrollment
≥ 4.0 Star Rating: 5%
bonus and top member
rebate payments
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 before
9% screened only
with FIT/FOBT
Screening history of
Cologuard users
18
Nationwide colon cancer screening call center
ensures patients complete Cologuard
68%
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 June 30, 2016. 19
Cologuard increases patient compliance
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
393 Cancers in
curable stage;
21 advanced
adenoma
4
Cologuard
compliance
88%
20
Source: Mayo Clinic poster presentation Su1044, Digestive Disease Week 2016
Knowledge of Cologuard
improves colonoscopy performance
2x
Polyps
discovered
46% more time spent
on colonoscopy
Mayo Clinic study compares results of colonoscopies
performed with, without knowledge of Cologuard result
21
A Strategy to Drive
Cologuard’s Adoption
22
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
23
Cologuard’s growing physician penetration
*IMS data based on heart drug prescriptions
4,100
8,300
14,700
21,000
27,000
200,000 potential Cologuard prescribers*
32,000
Q1 Q2 Q3 Q4 Q1
41,000
August
2014
June
2016
Q2
24
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 = 2,799
25
National TV campaign increasing ordering & adoption
26
Digital advertising complements national TV campaign
Website
visits
Patient guide
downloads
Order form
downloads
27
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
Millionsofcoveredlives
128M total
USPSTF
Medicare
Anthem
HCSC
BCBS
MA
CareFirst
BCBS
LA
Health
Net
Source: Kaiser Family Foundation 2015, AIS Directory of Health Plans: 2015
Quality
of care
Strategy to advance insurance coverage to contracting
Cost
savings
Member
satisfaction
Value proposition for payers
NEJM publication
shows 92% sensitivity
Easy, non-invasive test;
68% patient compliance
Cologuard can deliver
positive budget impact$
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
Cologuard growth accelerating in 2016
4,000
11,000
21,000
34,000
38,000 40,000
54,000
Q4 Q1 Q2 Q3 Q4 Q1 Q2
2014 2015 2016
65,000
guidance
Q3
Cologuard tests completed
31
Guidance
2015 2016
Projecting $90-100M revenue in 2016
104,000
$39.4M
>240,000
$90-100M
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)
Exact Sciences
(EXAS)
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
Exact Sciences (EXAS) 202,000
Panorama (NTRA) 201,000
MaterniT21 (SQNM) 133,900
Assurex (MYGN) 11,750
FoundationOne (FMI) 10,845
First 7 Quarter Test Volume (Top 5 Shown)
QuarterlyTestVolume
33
Second-quarter financial results
Revenues
Operating expenses
Cash utilization
Cash balance
$21.2 million
$56.2 million
$38.5 million
$224.1 million, as reported
$368.6 million, pro forma*
Second Quarter
2016
*Pro forma cash balance reflects inclusion of proceeds from the company’s July 2016 follow-
on equity offering (net proceeds of approximately $144.5 million) as if completed during Q2
34
35

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September 2016-corporate-presentation-final

  • 2. 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. 2
  • 3. OUR MISSION To partner with healthcare providers, payers, patients & advocacy groups to help eradicate colon cancer 3
  • 5. 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 41,78040,890 49,190 158,080 Esophageal Prostate Breast Pancreas Colorectal Lung Annual cancer deaths 132,700 deaths in 2015 49,700 134,490 new diagnoses 49,190 deaths 5
  • 6. 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 polyp Four stages of colon cancer 6
  • 7. 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
  • 8. 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 2015 Goals 8
  • 9. Cologuard addresses the colon cancer challenge  Stool DNA test: 11 biomarkers (10 DNA & 1 protein)  FDA-approved & covered by Medicare List 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
  • 10. Cancer detection 92% (60/65) Precancer detection 42% (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
  • 11. Three easy steps to using Cologuard: Get, Go, Gone 11
  • 13. 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 ***** **** 13
  • 14. Cologuard becoming standard of care Patient & physician demand increases with coverage & guideline inclusion Medicare Star Ratings** *Pending publication of HEDIS 2017 quality measures, expected October 2016 ** Medicare Advantage Star Measures are guided by HEDIS quality measures Regulatory & coverage Guideline inclusion Quality measures* 14
  • 15. Cologuard is “A” graded in current USPSTF colon cancer screening recommendations Sources: USPSTF, Final Recommendation Statement, Colorectal Cancer: Screening (June 2016) JAMA. 2016;315(23):2564-2575. doi:10.1001/jama.2016.5989 15
  • 16. 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
  • 17. 17Sources: CMS 2016 Star Ratings Fact Sheet Quality measures impacting Medicare Advantage plans Health plans aiming for ≥ 4 Star Rating to earn 5% bonus payments 12 66 112 102 65 12 Star Rating 54.543.532.5 2016 Medicare Advantage Plans Ratings by Star Level Key thresholds in Star Ratings: 5 Star Rating: year- round open enrollment ≥ 4.0 Star Rating: 5% bonus and top member rebate payments
  • 18. 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 before 9% screened only with FIT/FOBT Screening history of Cologuard users 18
  • 19. Nationwide colon cancer screening call center ensures patients complete Cologuard 68% 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 June 30, 2016. 19
  • 20. Cologuard increases patient compliance 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 393 Cancers in curable stage; 21 advanced adenoma 4 Cologuard compliance 88% 20
  • 21. Source: Mayo Clinic poster presentation Su1044, Digestive Disease Week 2016 Knowledge of Cologuard improves colonoscopy performance 2x Polyps discovered 46% more time spent on colonoscopy Mayo Clinic study compares results of colonoscopies performed with, without knowledge of Cologuard result 21
  • 22. A Strategy to Drive Cologuard’s Adoption 22
  • 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 23
  • 24. Cologuard’s growing physician penetration *IMS data based on heart drug prescriptions 4,100 8,300 14,700 21,000 27,000 200,000 potential Cologuard prescribers* 32,000 Q1 Q2 Q3 Q4 Q1 41,000 August 2014 June 2016 Q2 24
  • 25. 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 = 2,799 25
  • 26. National TV campaign increasing ordering & adoption 26
  • 27. Digital advertising complements national TV campaign Website visits Patient guide downloads Order form downloads 27
  • 28. 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
  • 29. Medical coverage accelerating following Cologuard’s inclusion in USPSTF recommendations - 20 40 60 80 100 120 140 Millionsofcoveredlives 128M total USPSTF Medicare Anthem HCSC BCBS MA CareFirst BCBS LA Health Net Source: Kaiser Family Foundation 2015, AIS Directory of Health Plans: 2015
  • 30. Quality of care Strategy to advance insurance coverage to contracting Cost savings Member satisfaction Value proposition for payers NEJM publication shows 92% sensitivity Easy, non-invasive test; 68% patient compliance Cologuard can deliver positive budget impact$ 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
  • 31. Cologuard growth accelerating in 2016 4,000 11,000 21,000 34,000 38,000 40,000 54,000 Q4 Q1 Q2 Q3 Q4 Q1 Q2 2014 2015 2016 65,000 guidance Q3 Cologuard tests completed 31
  • 32. Guidance 2015 2016 Projecting $90-100M revenue in 2016 104,000 $39.4M >240,000 $90-100M 32
  • 33. 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) Exact Sciences (EXAS) 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 Exact Sciences (EXAS) 202,000 Panorama (NTRA) 201,000 MaterniT21 (SQNM) 133,900 Assurex (MYGN) 11,750 FoundationOne (FMI) 10,845 First 7 Quarter Test Volume (Top 5 Shown) QuarterlyTestVolume 33
  • 34. Second-quarter financial results Revenues Operating expenses Cash utilization Cash balance $21.2 million $56.2 million $38.5 million $224.1 million, as reported $368.6 million, pro forma* Second Quarter 2016 *Pro forma cash balance reflects inclusion of proceeds from the company’s July 2016 follow- on equity offering (net proceeds of approximately $144.5 million) as if completed during Q2 34
  • 35. 35