exas september 2017 corporate presentation final
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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," “goal,” "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 patients, healthcare
providers, payers & advocacy groups to
help eradicate colon cancer
3
Source: American Cancer Society, Cancer Facts & Figures 2017; all figures annual
Colon cancer: America’s second deadliest cancer
new diagnoses in 2015
15,690
26,730
41,070 43,09050,260
155,870
Esophageal Prostate Breast Pancreas Colorectal Lung
Annual cancer deaths
132,700
deaths in 2015
49,700
135,430new diagnoses
50,260deaths
4
10+ years
Sources: J Natl Cancer Inst. 2009; 101:1225-1227 (Itzkowitz)
Gastro 1997;112:594-692 (Winawer)
Pre-cancerous polyp Cancer
5
“The most preventable, yet
least prevented form of cancer”– Journal of the National Cancer Institute
Sources: SEER 18 2004-2010
American Cancer Society, Cancer Facts & Figures 2017; 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
Majority of patients diagnosed in stages III-IV
6
Rx Only
50%52%
59% 58%62%
80% goal
2005 2008 2010 2013 2015 2018
Sources: CDC NHIS survey results as published in the CDC’s MMWR between 2006 and 2017
Actual colon cancer screening rates
America’s stagnant colon cancer screening rate
7
Rx OnlySource: Imperiale TF et al., N Engl J Med (2014)
developed with
Cologuard: Addressing the colon cancer challenge
94% early-stage cancer sensitivity
Easy-to-use & non-invasive while requiring
no preparation, sedation, or time off work
FDA approved & included in major guidelines
Insurance coverage for 86% of addressable
population (80M+ people), including Medicare
8
9Source: Mayo Clinic poster presentation Su1044, Digestive Disease Week 2016
Knowledge of positive Cologuard improves
colonoscopy performance
46% more time spent
on colonoscopy
Mayo Clinic study compares results of unblinded, blinded colonoscopies
2xPolyps
discovered
32%Increase in
pre-cancer detection
4xHigher flat right-sided
lesion detection
Welcome call 24/7 patient
support line
Cologuard
delivered to home
Reminder call
Reminder letter
66Patient compliance
Driving patient compliance with colon cancer screening
Cologuard’s compliance rate is derived from the number of completed tests reported divided by the number of collection kits
shipped to patients during the 12-month period ending 60 days prior to June 30, 2017, excluding program orders.
10
%
Sources: *Patient adherence over 3 years’ Liang PS., et al., Am J Gastroenterol. 2016
**Patient compliance within 1 year; Arch Intern Med 2012; 172(7):575-582 (Inadomi)
***Cologuard’s compliance rate is derived from the number of completed tests reported divided by the number of collection kits shipped to
patients during the 12-month period ending 60 days prior to June 30, 2017, excluding program orders.
11
Impact of patient navigation service on compliance
colonoscopy**
38%
***
66%
FOBT*
14%
11
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%
12
*Exact Sciences internal estimates based upon prevalence and detection rates from DeeP-C study
(Imperiale TF et al., N Engl J Med (2014)
Impact of Cologuard during second quarter 2017*
~600early-stage
cancers
~200late-stage
cancers
135,000completed
Cologuard tests
Early-stage colorectal cancer detected in more than 6 patients a day
13
Strong customer satisfaction with Cologuard
Physicians’
expectations
met or exceeded 96%
Patients rated
Cologuard experience
very positive89%Sources: ZS survey conducted for Exact Sciences Oct-Dec 2016, n=300
Exact Sciences Laboratories patient satisfaction survey Jan-Jun 2017; n = 2,91914
15
Commercial strategy engages key audiences
National TV
campaign
and digital
marketing
Patients
Payers
Market access team and
clinical & health publications
Primary care
sales force
and collateral
materialsPhysicians &
Systems
Patients
Exact Sciences nationwide sales force:
Establishing a new standard for colon cancer screening
Primary care sales force
• Focus on top potential physician offices
• Educate physicians & office staff
• Improve repeat ordering of Cologuard
Inside sales force
• Extend reach of sales force coverage
• Support field in education efforts
• New physician outreach and pull through
17
$1.5 $4.3
$8.1 $12.6 $14.4 $14.8
$21.2
$28.1
$35.2
$48.4
$57.6
Cologuard revenue growth
2015 2016
Quarterly Cologuard revenue ($ Millions)18
Launch of
national
TV campaign
2017
$383 $386
$393
$405
$418 $423
Time-lagged average revenue per test improving
2016
19
2017
Note: average Cologuard reimbursement from all sources on a trailing
12 month basis for tests that were completed at least 6 months ago
2%***
20
A multi-billion dollar U.S. market opportunity
*80 million average-risk, asymptomatic people ages 50-85
**Assumes average revenue per test of $500-525 and 3-year testing interval for Cologuard
***(135,000 completed tests * 4 to annualize * 3 to account for testing interval) / 80M
80M+Potential U.S. screening
market for Cologuard*
$14B Total Addressable Market**
4,0008,000
15,00021,000
27,000
32,000
41,000
50,000
60,000
70,000
81,000Cologuard’s growing provider penetration
2015 2016
Cumulative Cologuard ordering providers
2017
Launch of
national
TV campaign
21
Coverage accelerated following Cologuard inclusion in
USPSTF recommendations
2015 2016
236M total
USPSTF
Source: US Census data, AIS Directory of Health Plans: 2016, Exact Sciences Analysis 22
86% of Cologuard’s addressable market covered
2017
Cologuard becoming the standard of care
Additional coverage driven by data, guidelines and quality measures
23
>85%
insurance
coverage
2009-2013 2014 2015 2017
developed
with Mayo
Clinic
10,000
patient
DeeP-C trial guidelines
HEDIS quality
measures
Medicare
Star Ratings
coverage
approval
&
2016
guidelinesreconfirmed
performance
recommended
by USPSTFtrial results
published
Cologuard: Increasing America’s screening population
Exact Sciences Laboratories patient survey data May-Jun 2017; n = 993
38% screened with
colonoscopy
51% never
screened before
11% screened only
with FIT/FOBT
Screening history of
Cologuard users
24
25
Exact Sciences is a data-driven companyInformation from over 585,000 patients and 81,000 physicians
Increase compliance and
repeat screeningPatients
Improve quality measures
and outcomesPhysicians
Improve quality measures
and reporting capabilitiesPayers
27
14Mnew cancer
cases &
8.8Mdeaths
Source: World Health Organization and Centers for Disease Control and Prevention
Cancer’s annual impact nationally and globally
1.6Mnew cancer
cases &
600kdeaths
Expected 70% increase in new cases within 20 years
Unique collaboration & platform target deadliest cancers
Regulatory, scientific,
and commercial
expertise
Exact SciencesClinical trials, access
to samples, and key
opinion leader support
Mayo ClinicQuARTS™ PCR
chemistry and Cologuard
instrumentation
Technology Platform
Identifying specific, proprietary cancer DNA markers to facilitate early detection
28
29
Advantages of the Exact Sciences approach
Methylation markers enable cancer site specificity
Cost advantages over Next-Generation Sequencing (NGS)
High specificity & sensitivity achieved with few markers
Source: Analyst estimates
Liquid biopsy: A growth area for cancer diagnostics
2015 2030
Projected
liquid biopsy
market
>$13B
$200M
Exact Sciences focusing on early detection & recurrence
Screening
Diagnostic aid
Minimum residual disease
Recurrence monitoring
Response monitoring
Response profiling
Targeted therapy selection
Clinical applications
30
31
A need and opportunity in diagnosing lung cancer
Biopsy
Surgery
1.5-3M lung
nodules discovered
annually*
$750M
to $1.5BInvasive,
expensive, and
harmful
The
Problem
Current
Options
Potential
Opportunity
Blood-based
biomarker test
**
*Gould et al., Am J Respir Crit Care Med (2015)
**Total Addressable Market assumes average revenue per test of $500
CT
scans
Second-quarter 2017 financial results
Second Quarter
2017
Revenue $57.6 million $48.4 million
Gross margin 69% 65%
Operating expense $71.1 million $66.9 million
Cash utilization $43.9 million $36.4 million
Ending cash balance $484.3 million $274.7 million
32
First Quarter
2017
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