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Corporate Presentation
June 2017
Corporate Presentation v June 2017 Safe harbor statement This - - PowerPoint PPT Presentation
Corporate Presentation v June 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,
v
Corporate Presentation
June 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," "estimate," "anticipate" or other comparable2
OUR MISSION
To partner with healthcare providers, payers, patients & advocacy groups to
help eradicate colon cancer
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Becoming the leader in advanced cancer diagnostics
Mission & vision
RegulatUse deep regulatory, guideline & reimbursement experience
Commercial expertise Clinical knowledge Innovation Product breadth Unique experience
Extend Cologuard platform to next generation of liquid biopsy cancer diagnostics Proven leader in technology & business model Leverage Mayo Clinic collaboration & internal knowledge Build on commercial capabilities to reach physicians & patients
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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 Powered by advanced DNA technology Easy-to-use & non-invasive while requiring no preparation, sedation, or time-off FDA approved & included in major guidelines Insurance coverage for 78% of addressable population (80M people), including Medicare
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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 March 31, 2017, excluding program orders.10
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Impact of patient navigation service on compliance
colonoscopy**
38%
***
67%
FOBT*
14%
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Strong customer satisfaction with Cologuard
Physicians’ expectations met or exceeded 98% Patients rated Cologuard experience very positive
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Impact of Cologuard during first quarter 2017*
~450
early-stage cancers
~600
cancers
100,000
completed Cologuard tests
Early-stage colorectal cancer detected in ~5 patients a day
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~$14B total addressable market**
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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 and 3 year interval for CologuardPotential U.S. screening market for Cologuard* 2%
Commercial strategy engages key audiences
Physicians
Primary care sales force Publications Collateral materials
Payers
Clinical & health publications Market access team Major screening guidelines
Patients
Public relations Digital marketing National TV campaign
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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
primary care physician offices
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 $48.4
Cologuard revenue growth accelerating
2015 2016
Quarterly Cologuard revenue ($ Millions)
18 Launch of national TV campaign
2017
4,000 8,000 15,000 21,000 27,000 32,000 41,000 50,000 60,000 70,000
Cologuard’s growing provider penetration
2015 2016
Cumulative Cologuard ordering providers
2017
Launch of national TV campaign 19
Comparing Cologuard’s strong launch trajectory
BRACAnalysis (MYGN) Prolaris (MYGN) Oncotype Dx Prostate (GHDX) Oncotype Dx Breast/Colon (GHDX) FoundationOne (FMI) MaterniT21 (SQNM) Panorama (NTRA) Afirma (VCYT) VectraDA (MYGN) Assurex (MYGN)0K 20K 40K 60K 80K 100K 120K 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19
Launch year Quarterly test volume
(EXAS)
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Coverage accelerating following Cologuard inclusion in USPSTF recommendations
2015 2016
197M total USPSTF
Source: US Census data, AIS Directory of Health Plans: 201621
78% of Cologuard addressable market covered 2017
Cologuard becoming the standard of care
Additional coverage driven by data, guidelines and quality measures
Guidelines Quality measures
Medicare Star Ratings
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Regulatory
Cologuard: Increasing America’s screening population
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 50-7449% screened with colonoscopy 42% never screened before 9% screened only with FIT/FOBT Screening history of Cologuard users
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Building a pipeline on Cologuard platform
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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Unique collaboration & platform target deadliest cancers
Identifying specific DNA methylation cancer biomarkers
Scientific expertise Regulatory approval Commercial experience & infrastructure
Exact Sciences
Access to samples & clinical trial expertise Support from key opinion leaders Guideline experience
Mayo Clinic
QuARTS™ chemistry Cologuard instrumentation Major cost advantage
Technology Platform
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The DNA methylation advantage
number of markers
small number of markers, is capable of driving major cost advantages over Next-Generation Sequencing (NGS) Our collaboration with Mayo Clinic has identified proprietary methylation markers for most major cancers
DNA methylation (epigenetics) changes genetic function without changing DNA sequence
Simplicity of Exact Sciences’ methylation approach
Liquid biopsy workflow for methylation markers Blood collection cfDNA extraction Bisulfite conversion QuARTS™ PCR Chemistry Cologuard instrument platform
& specificity
Advantages of Exact Sciences’ approach
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Multi-year collaboration with Mayo Clinic generating significant progress with top cancers
Marker Discovery Tissue Validation Blood Validation
DNA methylation markers identified Marker panel selected Assay performance determined
Marker discovery complete in 7 major cancers & blood validation complete in 4 major cancers
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Sensitivity 91-96% Specificity 90-94%
Source: Allawi et al., abstract to be presented at AACR (2017)Blood validation results for lung cancer
High accuracy achieved with four methylation markers in blood
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AUC 0.98 Sensitivity 95% Specificity 97%
Source: Dukek BA et al., AALSD 2016 (2016)Blood validation results for liver cancer
High accuracy achieved with three methylation markers in blood
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AUC 0.96 Sensitivity 95% Specificity 90%
Source: Majumder S et al., ACG 2016 (2016)Cyst fluid validation results for pancreatic cancer
Award winning abstract at ACG 2016
High accuracy achieved with two methylation markers in pancreatic cyst fluid
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Exact Sciences’ liquid biopsy offering could aid in diagnosis of lung cancer in patients with lung nodules
Is it cancer?
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Detecting lung cancer with a blood-based biomarker test
Is it cancer? CT scans Biopsy Surgery Blood-based biomarker test saves lives & reduces cost 1.5-3M lung nodules discovered annually
Unnecessary complications (overtreatment), delayed cancer treatment (under-treatment) and high costs 34
Results from a ~400-patient lung cancer study presented at AACR in April 2017
First-quarter 2017 financial results
First Quarter 2017
Revenues
$48.4 million $35.2 million
Gross margin
65% 61%
Operating expense
$66.9 million $59.1 million
Cash utilization
$36.4 million $26.7 million
Ending cash balance
$274.7 million $311.1 million
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Fourth Quarter 2016