4 q17 corporate deck final web version
TRANSCRIPT
![Page 1: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/1.jpg)
Corporate Presentation
1
Fourth Quarter 2017
November 2017
![Page 2: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/2.jpg)
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
Safe harbor statement
![Page 3: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/3.jpg)
Our Mission
To partner with patients, healthcare
providers, payers & advocacy groups
to help eradicate colon cancer
3
![Page 4: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/4.jpg)
4Source: American Cancer Society, Cancer Facts & Figures 2017; all figures annual
Colon cancer: America’s second deadliest cancerSource: American Cancer Society, Cancer Facts & Figures 2017; all figures annual
15,69026,730
41,070 43,09050,260
155,870
Esophageal Prostate Breast Pancreas Colorectal Lung
new diagnoses
135,430
deaths
50,260Annual Cancer Deaths
![Page 5: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/5.jpg)
Sources: J Natl Cancer Inst. 2009; 101:1225-1227 (Itzkowitz)
Gastro 1997;112:594-692 (Winawer) 5
“The most preventable, yet least prevented form of cancer”– Journal of the National Cancer Institute
10+ years
Pre-cancerous polyp Cancer
![Page 6: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/6.jpg)
6Sources: SEER 18 2004-2010
American Cancer Society, Cancer Facts & Figures 2017; all figures annual
Detecting colorectal cancer early is critical
Diagnosed in Stages I or II
survive 5 years
9 of 10
Diagnosed in Stage IV
survive 5 years
1 of 10
![Page 7: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/7.jpg)
7Sources: CDC NHIS survey results as published in the CDC’s MMWR
between 2006 and 2017
America’s stagnant colon cancer screening rate
50% 52%
59% 58%62%
80% goal
Actual colon cancer screening rates
2005 2008 2010 2013 2015 2018
![Page 8: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/8.jpg)
8Source: Imperiale TF et al., N Engl J Med (2014)
Cologuard: Addressing the colon cancer challenge
94% early stage cancer sensitivity
developed with
of addressable population with insurance
coverage (80M+ people), including Medicare87%
Easy-to-do & non-invasive with no preparation,
sedation, or time off
FDA approved & included in major guidelines
![Page 9: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/9.jpg)
Source: Mayo Clinic poster presentation Su1044, Digestive Disease Week 2016 9
Knowledge of positive Cologuard improves colonoscopy performanceMayo clinic study compares results of unblinded, blinded colonoscopies
46%more time spent
on colonoscopy
2x
32%
4x
Polyps discovered
Increase in pre-cancer detection
Higher flat right sided lesion
detection
![Page 10: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/10.jpg)
10Cologuard’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 Sep. 30, 2017, excluding program orders
Driving patient compliance with colon cancer screening
66%Patient compliance
Welcome call 24/7 patient
support lineCologuard delivered to home Reminder calls Reminder letter
![Page 11: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/11.jpg)
11
Impact of patient navigation service on compliance
FOBT* colonoscopy**
14%
38%
66%
***
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 Sep. 30, 2017, excluding program orders
![Page 12: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/12.jpg)
American Association of Cancer Research Annual meeting 2016, New Orleans LA
USA, LB-296, Proceedings of the American Association of Cancer Research, in press 12
Cologuard increases patient complianceUSMD study highlights opportunity to expand screening & detect curable-stage cancer
Non-compliant Medicare patients
393Cologuard compliance88%
Cancers detected in curable stage4Advanced adenoma detected21
![Page 13: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/13.jpg)
13Sources: ZS survey conducted for Exact Sciences Oct-Dec 2016, n=300
Exact Sciences Laboratories patient satisfaction survey Jan-Sep 2017; n = 4,328
Strong customer satisfaction with Cologuard
Physicians’ expectations
met or exceeded
Patients rated Cologuard
experience very positive
88%96%
![Page 14: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/14.jpg)
14
Commercial strategy engages key audiences
Market access team and
clinical & health publications
Payers
Primary care sales force
and collateral materials
Providers & Systems
National TV campaign
and digital marketing
Patients
![Page 15: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/15.jpg)
15
National TV campaign increasing ordering & adoption
![Page 16: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/16.jpg)
16
Exact Sciences nationwide sales forceEstablishing 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
• Extend reach of sales force coverage
• Support field in education efforts
• New physician outreach and pull through
Inside sales force
![Page 17: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/17.jpg)
$1.5$4.3
$8.1$12.6 $14.4
$14.8$21.2
$28.1
$35.2
$48.4
$57.6
$72.6
17
Cologuard revenue growth increasing
2015 2016
Quarterly Cologuard revenue ($ Millions)
Launch of national
TV campaign
2017
![Page 18: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/18.jpg)
$383$386
$393
$405
$418
$423$428
18
Time-lagged average revenue per test improving
2016 2017
Note: average Cologuard reimbursement from all sources on a trailing 12 month
basis for tests that were completed at least 6 months ago
![Page 19: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/19.jpg)
19
A multi-billion dollar U.S. market opportunity
*80 million average-risk, asymptomatic people ages 50-85, **Assumes ASP of $500-525 and 3-year
interval for Cologuard, ***(161,000 completed tests * 4 to annualize * 3 to account for interval) / 80M
80M+
2%
Potential U.S. screening
market for Cologuard*
$14BTotal Addressable Market**
market share***
![Page 20: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/20.jpg)
4,0008,000
15,00021,000
27,000
32,000
41,000
50,000
60,000
70,000
81,000
91,000
20
Cologuard’s growing provider penetration
2015 2017
Cumulative Cologuard ordering providers
Launch of national
TV campaign
2016
![Page 21: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/21.jpg)
21Source: US Census data, AIS Directory of Health Plans: 2016, Exact Sciences Analysis
Coverage accelerated following Cologuard inclusion in USPSTF recommendations
2015 2016 2017
239M
USPSTF87%of Cologuard addressable
market covered
Total covered lives
![Page 22: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/22.jpg)
22
Cologuard becoming standard of careAdditional coverage driven by data, guidelines, and quality measures
>85%
insurance
coverage
2009-2013 2014 2015 2017
10,000 patient
DeeP-C trial guidelines
HEDIS quality
measures
Medicare Star
Ratings
coverage
approval
&
2016
guidelinesreconfirmed
performance
recommended by
USPSTFtrial results
published
developed
with Mayo
Clinic
![Page 23: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/23.jpg)
23Source: NCQA Health Insurance Plan Ratings 2017
Improving HEDIS scores through colorectal cancer screening
<1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0
50%Screening rate
73%Screening rate
HEDIS Score
![Page 24: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/24.jpg)
Exact Sciences Laboratories data, Patient Satisfaction Survey, May-Sep 2017; n = 2,40524
Cologuard: Increasing America’s screening populationScreening history of Cologuard users
39% screened with colonoscopy
12% screened only with FIT/FOBT
49%never screened before
![Page 25: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/25.jpg)
25
Exact Sciences is a data-driven company
Improve quality measures and
outcomes
PayersImprove quality measures and
reporting capabilities
Providers
Increase compliance and
repeat screening
Patients
Patients
>750,000
Health care providers
>91,000
![Page 26: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/26.jpg)
Building a pipeline on Cologuard platform
26
![Page 27: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/27.jpg)
Source: World Health Organization and Centers for Disease Control and Prevention 27
Cancer’s annual impact globally, nationallyExpected 70% increase in new cases within 20 years
1.6Mnew cancer cases
600kdeaths
14Mnew cancer cases
8.8Mdeaths
![Page 28: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/28.jpg)
28
Exact Sciences’ advantages provide a unique position in liquid biopsy
Collaboration
with Mayo
Clinic
Exact Sciences’
proven experience
Proprietary
technology &
platform
Multi-marker
approach
Cost advantages
over sequencing
5+ years of
development
![Page 29: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/29.jpg)
Source: Analyst estimates 29
Liquid biopsy: A growth area for cancer diagnosticsExact Sciences focusing on early detection & recurrence
Projected
liquid biopsy market>$13B
$200M
Screening
Minimum residual disease
Recurrence monitoring
Response monitoring
Targeted therapy selection
Clinical applications
Diagnostic aid
Response profiling2015 2030
![Page 30: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/30.jpg)
30*Gould et al., Am J Respir Crit Care Med (2015), **Total Addressable Market assumes ASP of $500
A need and opportunity in diagnosing lung cancer
1.5-3M lung nodules
discovered annually*
Invasive, expensive,
and harmful
Biopsy
SurgeryCT
scans
The Problem Current Options
$750M-$1.5B
Blood-based biomarker test
Potential Opportunity
**
![Page 31: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/31.jpg)
31Source: Allawi et al., abstract presented at AACR (2017)
Blood validation results for lung cancerHigh accuracy achieved with four methylation markers in blood
>90%Sensitivity & Specificity
87cancers
311controls
398sample size
![Page 32: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/32.jpg)
32
Third-quarter 2017 financials
Q3 2017
Revenue $72.6 million $57.6 million
Gross margin 71% 69%
Operating expense $80.3 million $71.1 million
Cash utilization $21.7 million $43.9 million
Ending cash balance $462.5 million $484.3 million
Q2 2017
![Page 33: 4 q17 corporate deck final web version](https://reader034.vdocuments.site/reader034/viewer/2022050613/5a6479777f8b9a4c568b4697/html5/thumbnails/33.jpg)
33