exact sciences corporate presentation: june 2016
TRANSCRIPT
vCorporate Presentation
June 2016 – updated
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.
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OUR MISSION
To partner with healthcare providers,
payers, patients & advocacy groups to
help eradicate colon cancer
3
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
41,780 40,890
49,190
158,080
Esophageal Prostate Pancreas Breast Colorectal Lung
Annual cancer deaths
132,700
deaths in 2015
49,700
134,490new diagnoses
49,190deaths
4
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
5
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
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 20157
Goals
Three easy steps to using Cologuard
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Cologuard: Addressing 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 American Cancer Society guidelines & final USPSTF recommendations at 3 year interval
Source: Imperiale TF et al., N Engl J Med (2014)
Developed with
Mayo Clinic
9
10Source: US Preventive Services Task Force (2016). Screening for colorectal cancer: US preventive
services task force recommendation statement. JAMA. Epub ahead of print. doi:10.1001/jama.2016.5989
Cologuard included in final
2016 USPSTF recommendations
• Final recommendations removes “alternative” category and
includes 3-year interval analysis
• Task Force eliminates ambiguity and hierarchy created in
draft recommendations
• Additional scientific literature and public comments
shaped final recommendations
• Cologuard should receive benefits given to A-rated
preventive services under the Affordable Care Act
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 11
Sources:
1 Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med 2014; 370: 1287-1297.
2 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.
3 Berger BM, Schroy PC, 3rd, Dinh TA. Screening for Colorectal Cancer Using a Multitarget Stool DNA Test: Modeling the Effect of the Inter-test Interval on Clinical Effectiveness. Clin
Colorectal Cancer 2015.Epub ahead of print.
4 Berger BM, Parton M, Levin B, USPSTF Colorectal Cancer Screening Guidelines: An Extended Look at Multi-Year Interval Testing, Am J Managed Care 2016 22(2):e77 – e81.
5 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 March 31, 2016..
6 Abola MV, Fennimore TF, Chen MM, et al. DNA-based versus colonoscopy-based colorectal cancer screening: patient perceptions and preferences. Fam Med Commun H 2015; 3: 2-8.
Comprehensive case for Cologuard
Cancer detection >90% in two studies1, 2
Superior performance
Versus other screening methods3
Cost-effective
Analysis of independent modeling4
3-year interval
69% compliance with Cologuard kits shipped5
Compliance program
75% of patients consider more suitable than colonoscopy
84% of patients would repeat Cologuard, if recommended6
Patient
satisfaction
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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 recent study
March 2014 October 2015
41%(31/76)
100%(10/10)
93%(296/318)
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1FDA Advisory Panel material, Epigenomics AG PMA P130001, March 26, 20142Company website3Company news release dated Feb. 17, 20164Stages I-II; does not report Stage I only55-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 SensitivityAll stages
Sensitivity Stage I
Specificity Lifetime
False+
3 years 92% 90% 90% 1.2
EpigenomicsEpi 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
14
Source: American Journal of Managed Care, February 2016
Virtually no adherence to annual colon cancer screening
3 of 1,000 continuously-insured people adhere to FIT / FOBT recommendations
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$11,313
per QALYs
$15,500
per QALYs
$30,000
per QALYs
Modeling supports Cologuard as cost-effective
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 compares favorably with established screening strategies
16
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
Complications per thousand
Life years gained per thousand
Deaths averted per thousand
17
Cologuard increases patient compliance
13
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
393Cancers in
curable stage;
21 advanced
adenoma
4Cologuard
compliance
88%
19Source: Mayo Clinic poster presentation Su1044, Digestive Disease Week 2016
Knowledge of positive Cologuard
improves Colonoscopy performance
2xPolyps
discovered46% more time spent
on colonoscopy
Mayo Clinic study compares results of unblinded, blinded colonoscopies
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
20
Only 24/7/365 nationwide colon cancer screening
network drives compliance
69%
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 March 31, 2016. 21
Three-pronged commercial strategy
Physicians
Primary care
sales force
National TV campaign
Digital marketing
Payers
Clinical & health
publications
Market access
team
GuidelinesPatients
Public relations
Multi-channel
direct to consumer
National TV campaign
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Cologuard’s growing physician penetration
*IMS data based on heart drug prescriptions
August
2014
March
2016
4,100
8,300
14,700
21,000
27,000
200,000 potential Cologuard prescribers*
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32,000
Q1 2015 Q2 2015 Q3 2015 Q4 2015 Q1 2016
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 = 2,79924
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
104,000completed
Cologuard tests
600cancers
500early-stage
cancers
25
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Targeted TV ads impacting ordering & adoption
Cologuard
orders +50%
New
physician
adoption +100%
Average boost in
test vs. control markets
Ad available at CologuardTest.com
Percentage point growth compares 9-week average between TV test and control markets.
Tested in 5 markets between January – March 2016: Atlanta, Baltimore, Milwaukee/Madison, Sacramento & Tampa Bay
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;
69% patient compliance
Cologuard delivering
positive budget impact$27
46% 46%
8%
Source: US Census 2013 and AIS Directory of Health Plans: 2015; ages 50-8528
Medicare Commercial
Military &
Medicaid
Breakdown of current U.S. insurance market ~80M average-risk people age 50-85
Cologuard covered by Medicare
69%
31%
Medicare
Advantage
Traditional
fee-for-service
Medicare
Source: US Census 2013 and AIS Directory of Health Plans: 2015; ages 50-85
More than 37M average-risk Medicare patients ages 50-85
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Medicare Advantage
plans are required to
treat Cologuard as an
in-network benefit for
cost-sharing purposes
75% 25%
Pursuing Coverage Covered
Source: US Census 2013 and AIS Directory of Health Plans: 2015; ages 50-85
Achieving 25% commercial coverage for Cologuard
30
58 million lives covered by
commercial plans, including:
• Anthem
• Horizon BCBS
• BCBS Massachusetts
• CareFirst BCBS
• Independence Blue Cross
• BCBS Louisiana
• Excellus BCBS
• Harvard Pilgrim Healthcare
• Tufts Health Plan
• Government Employees
Health Association
• Priority Health
• Johns Hopkins Health Plan
• among other plans
Insures 37.6 million people nationwide
Second largest insurer in U.S.
Anthem enters into agreements by network/region
• Currently contracted: CA, VA and GA
• Latest contracts completed as of June 1: IN, KY, MO, OH and WI
• ~70% of Anthem’s members live in these regions
Sources: Estimate based on US Census data and enrollees
AIS Directory of Health Plans: 2015
Anthem contracting progressing quickly
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100%
32
Insurance coverage drives order growth
Growth rates measured from March 29, 2015 to March 26, 2016
Percentage-point increase in
order growth in 10 states with
highest insurance coverage,
compared to rest of country
Guidance
2015 2016
Projecting $90-100M revenue in 2016
104,000
$39.4M
>240,000
$90-100M
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First-Quarter 2016 financial results
Revenues
Operating expenses
Cash utilization
Cash balance
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First Quarter
2016
$14.8 million
$53.7 million
$44.3 million
$262.6 million
80M-person addressable marketLow satisfaction, compliance with
historically-available options
Strong intellectual property protectionCostly 5-10 year product development,
FDA and CMS pathway to approval
Compliance engine3-year adherence drives recurring revenue
Cost and satisfactionNear-term savings; increasing screening rates
High product
satisfaction
Patients and physicians want CologuardMet or exceeded expectations of 98% of physicians;
88% of patients rated experience very positive
Value to payers
Only national network
for CRC screening
High barrier to entry
Large market
opportunity
Cologuard: An opportunity for long-term growth
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