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Corporate Presentation
August 2017
Corporate Presentation v August 2017 Safe harbor statement This - - PowerPoint PPT Presentation
Corporate Presentation v August 2017 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
v
Corporate Presentation
August 2017
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 our2
OUR MISSION
To partner with patients, healthcare providers, payers & advocacy groups to
help eradicate colon cancer
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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 LungAnnual cancer deaths
132,700
deaths in 2015
49,700
new diagnoses
deaths
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10+ years
Sources: J Natl Cancer Inst. 2009; 101:1225-1227 (Itzkowitz) Gastro 1997;112:594-692 (Winawer)Pre-cancerous polyp Cancer
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“The most preventable, yet least prevented form of cancer”
– Journal of the National Cancer Institute
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
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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 2017Actual colon cancer screening rates
America’s stagnant colon cancer screening rate
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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 FDA approved & included in major guidelines Insurance coverage for 86% of addressable population (80M+ people), including Medicare
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Source: Mayo Clinic poster presentation Su1044, Digestive Disease Week 2016Knowledge of positive Cologuard improves colonoscopy performance
46% more time spent
Mayo Clinic study compares results of unblinded, blinded colonoscopies
2x
Polyps discovered
32%
Increase in pre-cancer detection
4x
Higher flat right-sided lesion detection
Welcome call 24/7 patient support line Cologuard delivered to home Reminder call Reminder letter
Patient 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
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Impact of patient navigation service on compliance
colonoscopy**
38%
***
66%
FOBT*
14%
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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 pressNon-compliant Medicare patients
Cancers in curable stage; 21 advanced adenoma
Cologuard compliance
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Impact of Cologuard during second quarter 2017*
~600
early-stage cancers
~200
late-stage cancers
135,000
completed Cologuard tests
Early-stage colorectal cancer detected in more than 6 patients a day
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Strong customer satisfaction with Cologuard
Physicians’ expectations met or exceeded 96% Patients rated Cologuard experience very positive
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Commercial strategy engages key audiences
National TV campaign and digital marketing
Patients Physicians & Systems Payers
Market access team and clinical & health publications Primary care sales force and collateral materials
National TV campaign increasing ordering & adoption
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Exact Sciences nationwide sales force: Establishing a new standard for colon cancer screening
Primary care sales force
Inside sales force
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$1.5 $4.3 $8.1 $12.6 $14.4 $14.8 $21.2 $28.1 $35.2 $48.4 $57.6
Cologuard revenue growth increasing
2015 2016
Quarterly Cologuard revenue ($ Millions)
18 Launch of national TV campaign
2017
$383 $386 $393 $405 $418 $423
Time-lagged average revenue per test improving
2016
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2017
Note: average Cologuard reimbursement from all payers on a trailing 12 month basis for tests that are at least 6 months old20
$3,660 $2,256 $1,656 $1,437 $1,574 $1,224 $972 $895 $838 $661
1Q 2015 1Q 2016 1Q 2017
S&M G&A COGS R&D Test Volume
As Cologuard volume grows, cost per test is decreasing
Note: total expense divided by tests completed in the quarter2%
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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 ***(135,000 completed tests * 4 to annualize * 3 to account for interval) / 80MPotential U.S. screening market for Cologuard* $14B Total Addressable Market**
4,000 8,000 15,000 21,000 27,000 32,000 41,000 50,000 60,000 70,000 81,000
Cologuard’s growing provider penetration
2015 2016
Cumulative Cologuard ordering providers
2017
Launch of national TV campaign 22
Coverage accelerated following Cologuard inclusion in USPSTF recommendations
2015 2016
235M total USPSTF
Source: US Census data, AIS Directory of Health Plans: 2016, Exact Sciences Analysis23
86% of Cologuard addressable market covered 2017
Cologuard becoming the standard of care
Additional coverage driven by data, guidelines and quality measures
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>85% insurance coverage2009-2013 2014 2015 2017
developed with Mayo Clinic 10,000 patient DeeP-C trial guidelines HEDIS quality measures Medicare Star Ratings coverage approval &2016
guidelines reconfirmed performance recommended by USPSTF trial results publishedCologuard: Increasing America’s screening population
Exact Sciences Laboratories patient satisfaction survey data May-Jun 2017; n = 99338% screened with colonoscopy 51% never screened before 11% screened only with FIT/FOBT Screening history of Cologuard users
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Exact Sciences is a data-driven company
Information from over 585,000 patients and 81,000 physicians
Increase compliance and repeat screening
Patients
Improve quality measures and outcomes
Physicians
Improve quality measures and reporting capabilities
Payers
Building a pipeline on Cologuard platform
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new cancer cases &
deaths
Source: World Health Organization and Centers for Disease Control and PreventionCancer’s annual impact nationally and globally
new cancer cases &
deaths
Expected 70% increase in new cases within 20 years
Unique collaboration & platform target deadliest cancers
Regulatory, scientific, and commercial expertise
Exact Sciences
Clinical trials, access to samples, and key
Mayo Clinic
QuARTS™ PCR chemistry and Cologuard instrumentation
Technology Platform
Identifying specific, proprietary cancer DNA markers to facilitate early detection
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Advantages of the Exact Sciences approach
Methylation markers enable cancer site specificity Cost advantages over Next-Generation Sequencing (NGS) High specificity & sensitivity with few markers
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
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A need and opportunity in diagnosing lung cancer
Biopsy Surgery
1.5-3M lung nodules discovered annually*
$750M
to $1.5B
Invasive, expensive, and harmful
The Problem Current Options Potential Opportunity
Blood-based biomarker test
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*Gould et al., Am J Respir Crit Care Med (2015) **Total Addressable Market assumes ASP of $500CT scans
Second-quarter 2017 financial results
Second Quarter 2017
Revenues
$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
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First Quarter 2017