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28th Annual ROTH Conference
Kevin Conroy, Chairman and CEO
March 14, 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 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
OUR MISSION
To partner with healthcare providers,
payers, patients & advocacy groups to help
3
eradicate colon cancer
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
134,490
new diagnoses
49,190
deaths
4Source: American Cancer Society, Cancer Facts & Figures 2016; all figures annual
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
5
Sources: SEER 18 2004-2010
American Cancer Society, Cancer Facts & Figures 2015; 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
6
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
7
Cologuard: Addressing the colon cancer problem
 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 American Cancer Society guidelines &
US Preventive Services Task Force draft guidelines
Source: Imperiale TF et al., N Engl J Med (2014)
Developed with
Mayo Clinic
8
A multi-billion dollar U.S. market opportunity
U.S. market opportunity
for Cologuard
$4B
Potential 80M-patient
U.S. screening market*
***
9*80 million average-risk, asymptomatic people ages 50-84
**Assumes unscreened decreases from 42% to 30%
***Assumes 24M people screened with Cologuard every three years with ASP of $500
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)
Mayo Clinic Proceedings, Oct 2015
Cologuard’s performance confirmed in recent study
March 2014 October 2015
41%
(31/76)
100%
(10/10)
93%
(296/318)
10
11
1FDA Advisory Panel material, Epigenomics AG PMA P130001, March 26, 2014
2Company website
3Company news release dated Feb. 17, 2016
4Stages I-II; does not report Stage I only
55-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 Sensitivity
All stages
Sensitivity
Stage I
Specificity Lifetime
False+
3 years 92% 90% 90% 1.2
Epigenomics
Epi 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
12Source: American Journal of Managed Care, February 2016
Virtually no adherence to colon cancer screening
from annual FIT / FOBT
Only 3 of 1,000 compliant people adhere to FIT / FOBT recommendations
$11,313
per QALYs
$15,500
per QALYs
$30,000
per QALYs
New modeling supports
Cologuard’s use every 3 years
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’s cost-effectiveness compares
favorably with established screening strategies
13
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
14
Complications per thousand
Life years gained per thousand
Deaths averted per thousand
Three-pronged commercial strategy
Physicians
Patients
Payers
Public relations
Multi-channel
direct to consumer
Primary care
sales force
Medical education
Digital campaign
Clinical & health
publications
Market access
team
Guidelines
Targeted TV test
15
16
Driving efficiency & impact through a total office call
2015
2016
Ensuring multiple physicians in practice order Cologuard
Q1 2015 Q2 2015 Q3 2015 Q4 2015
Cologuard’s growing physician penetration
*IMS data based on heart drug prescriptions
August
2014
December
2015
4,100
8,300
14,700
21,000
27,000200,000 potential Cologuard prescribers*
17
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
18
19
Three easy steps to using Cologuard
Targeted TV ads impacting Cologuard ordering & adoption
20
Positive early results
Cologuard
orders +40%
New
physician
adoption +80%
Tested in 5 markets since January 2016
• Atlanta
• Baltimore
• Milwaukee/Madison
• Sacramento
• Tampa Bay 5 week cumulative boost in
test versus control markets
Ad available at CologuardTest.com
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
104,000
completed
Cologuard tests
600
cancers
500
early-stage
cancers
19
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
22
23
Guidance
2015 2016
Projecting $90-100M revenue in 2016
104,000
$39.4M
>240,000
$90-100M
Quality
of care
Strategy to advance coverage to contracting
Cost
savings
Member
satisfaction
Value proposition for payers
NEJM publication
shows 92% sensitivity
Easy, non-invasive test;
>70% patient
compliance
Cologuard delivering
positive budget impact$
24
Medicare
Advantage
14%
Traditional
Medicare
32%
Aetna
Anthem
Cigna
UnitedHealthcare
22%
Commercial -
All others
24%
Source: US Census 2013 and AIS Directory of Health Plans: 2015; ages 50-85
Breakdown of current U.S. insurance market
46%
Medicare
46%
Commercial
25
8%
Medicaid/
Military
~80M average-risk people age 50-85
Medicare 100% covered
69%
31%
Medicare
Advantage
Traditional
Fee-for
Service
26Source: US Census 2013 and AIS Directory of Health Plans: 2015; ages 50-85
More than 37M average-risk Medicare patients ages 50-85
24%
34%
State law
mandates
coverage
Anthem
Harvard Pilgrim
Excellus BCBS
CareFirst BCBS
Pursuing coverage
Commercial market presently 24% covered
27
Success in
mandate states
would increase
commercial
coverage to 58%
Source: US Census 2013 and AIS Directory of Health Plans: 2015; ages 50-85
More than 37M average-risk commercial insurance patients ages 50-85
 37.6 million covered lives nationwide, second largest insurer in U.S.
 Strong presence in 14 states
• Largest plan in 6 states
• Second largest plan in 4 states
 Anthem enters into agreements by network/region
• California, Virginia & Georgia contracts completed
• ~50% of Anthem’s members currently under contract
 Parallel implementation of commercial pull through plan
Sources: Estimate based on US Census data and enrollees
AIS Directory of Health Plans: 2015
Nearly half of Anthem members accessing
Cologuard as an in-network service
28
 Colon cancer screening for individuals ages 50-75 given “A” rating
o Grades not assigned to specific tests
 Cologuard included in draft guidelines as alternative screening test useful in certain
clinical circumstance
o Replaces “I” grade given stool DNA in 2008
 USPSTF’s chairman publicly underscores these points following release of draft
guidelines*:
o “The central message is that it’s important to get screened.”
o “No direct evidence shows a clear advantage for either [invasive] approach or for
home-based tests or direct examination by doctors.”
o “Multiple screening strategies are available … we have more evidence to support
some than others.”
USPSTF draft guidelines
Sources:
*Congressional Quarterly/Roll Call, Task Force Makes Waves in Colon Cancer Test Market, October 25, 2015
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).
29
Focusing product pipeline on targeted opportunities
Lung
nodules
Pancreatic
cancer
2H
2016
Market
opportunity
blood test
pancreatic
juice
$1.0B
$0.5B+
Goal
Initial data
readout
Sources: *Silvestri GA et al. A Bronchial Genomic Classifier for the Diagnostic Evaluation of Lung Cancer. NEJM, 2015, 373, 243-251
Tanner NT et al. Management of Pulmonary Nodules by Community Pulmonologists: A Multicenter Observational Study. Chest. 2015 Dec 1;148(6):1405-14
2H
2016
30
Cologuard
improvements
2H
2016
$4.0B
optimize
margins
80M-person addressable market
Low satisfaction, compliance with current options
Strong intellectual property protection
Costly 5-10 year product development, FDA and
CMS pathway to approval
Compliance engine
3-year adherence drives recurring revenue
Cost and satisfaction
Near-term savings; increasing screening rates
High product
satisfaction
Patients and physicians want Cologuard
Met or exceeded expectations of 98% of physicians;
88% of patients rated experience very positive
31
Value to payers
Only national network
for CRC screening
High barrier to entry
Large market
opportunity
An attractive long-term opportunity
Fourth quarter and 2015 financial results
Revenue
Operating expenses
Cash utilization
Year-end cash balance
32
Fourth Quarter
2015
$14.4 million
$47.2 million
$36.6 million
Full Year
2015
$39.4 million
$174.0 million
$150.0 million*
$306.9 million
*The company raised $174.1 million in July 2015
33

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Roth Capital Partners' 28th Annual Roth Conference

  • 1. v 28th Annual ROTH Conference Kevin Conroy, Chairman and CEO March 14, 2016
  • 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 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
  • 3. OUR MISSION To partner with healthcare providers, payers, patients & advocacy groups to help 3 eradicate colon cancer
  • 4. 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 49,700 134,490 new diagnoses 49,190 deaths 4Source: American Cancer Society, Cancer Facts & Figures 2016; all figures annual
  • 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 5
  • 6. Sources: SEER 18 2004-2010 American Cancer Society, Cancer Facts & Figures 2015; 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 6
  • 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 7
  • 8. Cologuard: Addressing the colon cancer problem  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 American Cancer Society guidelines & US Preventive Services Task Force draft guidelines Source: Imperiale TF et al., N Engl J Med (2014) Developed with Mayo Clinic 8
  • 9. A multi-billion dollar U.S. market opportunity U.S. market opportunity for Cologuard $4B Potential 80M-patient U.S. screening market* *** 9*80 million average-risk, asymptomatic people ages 50-84 **Assumes unscreened decreases from 42% to 30% ***Assumes 24M people screened with Cologuard every three years with ASP of $500
  • 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) Mayo Clinic Proceedings, Oct 2015 Cologuard’s performance confirmed in recent study March 2014 October 2015 41% (31/76) 100% (10/10) 93% (296/318) 10
  • 11. 11 1FDA Advisory Panel material, Epigenomics AG PMA P130001, March 26, 2014 2Company website 3Company news release dated Feb. 17, 2016 4Stages I-II; does not report Stage I only 55-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 Sensitivity All stages Sensitivity Stage I Specificity Lifetime False+ 3 years 92% 90% 90% 1.2 Epigenomics Epi 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
  • 12. 12Source: American Journal of Managed Care, February 2016 Virtually no adherence to colon cancer screening from annual FIT / FOBT Only 3 of 1,000 compliant people adhere to FIT / FOBT recommendations
  • 13. $11,313 per QALYs $15,500 per QALYs $30,000 per QALYs New modeling supports Cologuard’s use every 3 years 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’s cost-effectiveness compares favorably with established screening strategies 13
  • 14. 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 14 Complications per thousand Life years gained per thousand Deaths averted per thousand
  • 15. Three-pronged commercial strategy Physicians Patients Payers Public relations Multi-channel direct to consumer Primary care sales force Medical education Digital campaign Clinical & health publications Market access team Guidelines Targeted TV test 15
  • 16. 16 Driving efficiency & impact through a total office call 2015 2016 Ensuring multiple physicians in practice order Cologuard
  • 17. Q1 2015 Q2 2015 Q3 2015 Q4 2015 Cologuard’s growing physician penetration *IMS data based on heart drug prescriptions August 2014 December 2015 4,100 8,300 14,700 21,000 27,000200,000 potential Cologuard prescribers* 17
  • 18. 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 18
  • 19. 19 Three easy steps to using Cologuard
  • 20. Targeted TV ads impacting Cologuard ordering & adoption 20 Positive early results Cologuard orders +40% New physician adoption +80% Tested in 5 markets since January 2016 • Atlanta • Baltimore • Milwaukee/Madison • Sacramento • Tampa Bay 5 week cumulative boost in test versus control markets Ad available at CologuardTest.com
  • 21. 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 104,000 completed Cologuard tests 600 cancers 500 early-stage cancers 19
  • 22. 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 22
  • 23. 23 Guidance 2015 2016 Projecting $90-100M revenue in 2016 104,000 $39.4M >240,000 $90-100M
  • 24. Quality of care Strategy to advance coverage to contracting Cost savings Member satisfaction Value proposition for payers NEJM publication shows 92% sensitivity Easy, non-invasive test; >70% patient compliance Cologuard delivering positive budget impact$ 24
  • 25. Medicare Advantage 14% Traditional Medicare 32% Aetna Anthem Cigna UnitedHealthcare 22% Commercial - All others 24% Source: US Census 2013 and AIS Directory of Health Plans: 2015; ages 50-85 Breakdown of current U.S. insurance market 46% Medicare 46% Commercial 25 8% Medicaid/ Military ~80M average-risk people age 50-85
  • 26. Medicare 100% covered 69% 31% Medicare Advantage Traditional Fee-for Service 26Source: US Census 2013 and AIS Directory of Health Plans: 2015; ages 50-85 More than 37M average-risk Medicare patients ages 50-85
  • 27. 24% 34% State law mandates coverage Anthem Harvard Pilgrim Excellus BCBS CareFirst BCBS Pursuing coverage Commercial market presently 24% covered 27 Success in mandate states would increase commercial coverage to 58% Source: US Census 2013 and AIS Directory of Health Plans: 2015; ages 50-85 More than 37M average-risk commercial insurance patients ages 50-85
  • 28.  37.6 million covered lives nationwide, second largest insurer in U.S.  Strong presence in 14 states • Largest plan in 6 states • Second largest plan in 4 states  Anthem enters into agreements by network/region • California, Virginia & Georgia contracts completed • ~50% of Anthem’s members currently under contract  Parallel implementation of commercial pull through plan Sources: Estimate based on US Census data and enrollees AIS Directory of Health Plans: 2015 Nearly half of Anthem members accessing Cologuard as an in-network service 28
  • 29.  Colon cancer screening for individuals ages 50-75 given “A” rating o Grades not assigned to specific tests  Cologuard included in draft guidelines as alternative screening test useful in certain clinical circumstance o Replaces “I” grade given stool DNA in 2008  USPSTF’s chairman publicly underscores these points following release of draft guidelines*: o “The central message is that it’s important to get screened.” o “No direct evidence shows a clear advantage for either [invasive] approach or for home-based tests or direct examination by doctors.” o “Multiple screening strategies are available … we have more evidence to support some than others.” USPSTF draft guidelines Sources: *Congressional Quarterly/Roll Call, Task Force Makes Waves in Colon Cancer Test Market, October 25, 2015 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). 29
  • 30. Focusing product pipeline on targeted opportunities Lung nodules Pancreatic cancer 2H 2016 Market opportunity blood test pancreatic juice $1.0B $0.5B+ Goal Initial data readout Sources: *Silvestri GA et al. A Bronchial Genomic Classifier for the Diagnostic Evaluation of Lung Cancer. NEJM, 2015, 373, 243-251 Tanner NT et al. Management of Pulmonary Nodules by Community Pulmonologists: A Multicenter Observational Study. Chest. 2015 Dec 1;148(6):1405-14 2H 2016 30 Cologuard improvements 2H 2016 $4.0B optimize margins
  • 31. 80M-person addressable market Low satisfaction, compliance with current options Strong intellectual property protection Costly 5-10 year product development, FDA and CMS pathway to approval Compliance engine 3-year adherence drives recurring revenue Cost and satisfaction Near-term savings; increasing screening rates High product satisfaction Patients and physicians want Cologuard Met or exceeded expectations of 98% of physicians; 88% of patients rated experience very positive 31 Value to payers Only national network for CRC screening High barrier to entry Large market opportunity An attractive long-term opportunity
  • 32. Fourth quarter and 2015 financial results Revenue Operating expenses Cash utilization Year-end cash balance 32 Fourth Quarter 2015 $14.4 million $47.2 million $36.6 million Full Year 2015 $39.4 million $174.0 million $150.0 million* $306.9 million *The company raised $174.1 million in July 2015
  • 33. 33