Exact Sciences Company Presentation Baird Healthcare Conference

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Transcript of Exact Sciences Company Presentation Baird Healthcare Conference

Diagnostics for the early detection and prevention of colon cancer

Corporate PresentationSeptember 2014

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Certain statements made in this news release contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and 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 comparable terms. Forward-looking statements in this news release may address the following subjects among others: statements regarding the sufficiency of our capital resources, expectations concerning our ability to secure and the timing of reimbursement for our Cologuard test, our estimated reimbursement amounts, our estimates of the available market size and our potential penetration, expected research and development expenses, expected general and administrative expenses and our expectations concerning our business strategy. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those 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 Reports on Form 10-Q. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.

Safe Harbor Statement

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OUR MISSIONTo partner with healthcare

providers, payers, patients and advocacy groups to help

eradicate colorectal cancer

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Exact Sciences Overview Executing on the Mission• Cologuard® is an FDA-approved, breakthrough, non-invasive

colorectal cancer screening test developed with Mayo Clinic• Uses a combination of DNA markers

– Detects 92% of cancers• First time in history FDA approved a technology, CMS

proposed national coverage on the same day– FDA approved on August 11, 2014– CMS proposes 3-year interval in preliminary coverage

decision• Multibillion-dollar global opportunity• 120-person sales force and growing

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FPO

Cologuard® FDA-approved, non-invasive screening test

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Cologuard FIT

Improvement P Value

Cancerdetection

92%(60/65)

73%(48/65) 25% 0.002

Advanced Adenomadetection

42%(321/757)

24%(180/757) 78% <0.001

N Engl J Med 2014;370:1287-97. DOI: 10.1056/NEJMoa1311194 (Imperiale)

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Cologuard Indications for Use

Cologuard is intended for the qualitative detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin human in stool. A positive result may indicate the presence of colorectal cancer (CRC) or advanced adenoma (AA) and should be followed by diagnostic colonoscopy. Cologuard is indicated to screen adults of either sex, 50 years or older, who are at typical average-risk for CRC. Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high risk individuals.

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Center for Medicare & Medicaid Services Update

• 3-year interval proposed by CMS• Preliminary pricing expected late Aug

or Sept• Final national coverage, pricing

expected Q4

CMS

Proposed Cologuard reimbursement crosswalk

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CologuardTMCrosswalk

Proposed Payment

2 DNA methylation markers

81315 ML/

RARalpha$282.83

7 DNA mutation markers

81275 KRAS $197.48

Fecal hemoglobin

82274 FIT $21.70

Total $502.01

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Mayo Clinic first system to adopt Cologuard

• ~600 primary care physicians• 1.2 patients seen annually

“…A critical step in beating this prevalent and preventable cancer.”- Vijay Shah, M.D., chair, gastroenterology & hepatology

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Stool DNA presently included in key cancer screening guidelines

sDNA testing included in American Cancer Society screening guidelines in 2008• Recommended for use by

average-risk patientsIncluded in American College of

Gastroenterology guidelines• 3-year interval for stool DNA

U.S. Preventative Services Task Force• 2015 update expected• If A/B rating, then all

commercial payers must cover test

12 Source: J Natl Cancer Inst. 2009; 101:1225-1227 (Itzkowitz)

– Journal of the National Cancer Institute

Major opportunity to improve colorectal cancer screening

The most preventable, yetleast prevented cancer.

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Detection and removal of polyps prevents cancer1

Pre-cancerous polyp

Stages of colon cancer

10-15years2

2Source Gastro 1997;112:594-692. (Winawer)1Source: N Engl J Med 2012;366:687-96 (Zauber)

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136,830

Source: ACS Cancer Facts & Figures 2014; all figures annual

Ovary Prostate Pancreas

Breast LungCervix

14,270

29,480

39,590

40,430

50,310

159,260

4,020

Annual U.S. cancer mortality

Colorectal cancer: the second-leading U.S. cancer killer

new U.S. cases

U.S. deaths50,310

Colorectal

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Late-stage detection leads to poor outcomes

Sources: CA Cancer J Clin 2008; 58:130-160 (Levin, B);ACS Colorectal Cancer Facts & Figures 2011-13; seer.cancer.gov/faststats

of cancers are detected late stage

60%

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Colorectal cancer costs significant and rising

annual treatment costs

$14BSource: J Natl Cancer Inst. 2011; 103:1-12 (Mariotto)

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Low screening rate contributes to colorectal cancer deaths

~50%of Americans are current for recommended colonoscopy screening

Source: ACS Cancer Prevention & Early Detection Facts & Figures 2013

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American Cancer Society Goal: 80% by 2018

Colorectal

Cervical

Cancer screening rates

83%

65%

ACS Cancer Prevention & Early Detection Facts & Figures 2013; Company estimates

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Current U.S. screening of average-risk patients

Source: CPT/HCPCS/ICD-9 Codes by Aileron Solutions; Company estimates

10.2M fecal blood tests

4.3M screening colonoscopies

14.5 million tests per year

55% FOBT

45%FIT

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Cologuard U.S. market opportunity

80M eligible for screening(>50 years old)

Source: Company estimates

>$2BPotential U.S. market30% penetration

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Despite inadequacies, FIT rapidly gained market share over FOBT

2004 2008 2012

2%

45%

Sources: Company estimates and CMS, Medicare Part B, Colorectal Cancer Screening

• Strategy of converting systems and high-volume users• Insignificant sales & marketing investment• Sensitivity advantages over FOBT• Without compliance engine

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Cologuard commercial strategyDrive

demandProvider

• Physician & system outreach• Medical

education• Publications

Promotecompliance

Patient • Direct advertising• Public relations• Compliance

engine

Securepayment

Payer • CMS parallel review• Managed care

team

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Cologuard launch underway

Large sales team

• 120 experienced sales leaders• Training

complete

Cutting-edge lab

& support

Targeted

marketing

• Strong program of PR, print, digital• Motivate patients

to talk with physician

• Successful end-to-end study• 1 million test per

year capacity

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Highest prescribing

primary care physicians

Large networksemploying large

number of primary care physicians

Source: Company estimates

Target segmentation

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Who represents our initial target physician?

• Orders 400 FIT or FOBT tests per year

• Practices in a group setting without a GI

• Female physicians, 15% more likely to recommend Cologuard

Ob-Gyns98% Internists94%

Family Practitione

rs92%

Receptive to recommending Cologuard

Source: Medspan research 2013; ZS Associates 2013 physician survey

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Cologuard market research Physicians

Source: Medspan research 2013; ZS Associates 2013 physician survey

percent of FOBT/FIT tests that would be replaced

with Cologuard by surveyed physicians74%

percent of physicians likely to order Cologuard

(67% very likely; 29% moderately likely)96%

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Cologuard market research Patients

more patients likely to get screenedthrough compliance program 2x

of patients likely to use Cologuard92%

Sources: Medspan research; Epidemiol Rev 2011; 33(1):101-110 (Levin, T); Compliance in commercially insured Kaiser patients increased from 34% to 69% from

2004 to 2010.

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Cologuard Sales team

• 3 regions• 10 large

system /hospital reps

• 80 PCP reps

• 10 area managers

• 6 clinical liaisons~10 years average health care sales

experience

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Cologuard Medical Education 2014

Speakers Bureau• 100 opportunities through end of year• ~30 trained speakers, including GIs and PCPsMedical Conferences• Cleveland Clinic Digestive Diseases Nursing

Symposium (Sept)• American College of Gastroenterologists (Oct)• American Association of Family Physicians (Oct)• Pri-Med Live & Online CME Meetings (Oct, Dec)

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www.CologuardTest.com

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Downloadable PDF can be brought to doctor’s office

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Cologuard Direct advertising

• Full-page ad in Sunday New York Times after approval• 1.2 million impressions• Dramatic increase in

clicks to www.CologuardTest.com through paid search

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Cologuard Direct advertising

• Consumer news, heath care sites: New York Times, WebMD• Customized ad networks to reach target patient and physician

profiles• Paid search to maximize consumer ability to find Cologuard

Digital campaign8 million

impressions in first

week

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Cologuard Public relations

Active effort to raise awareness of Cologuard• Cologuard featured in more than 360 unique news

outlets• Outlets and sites reach more than 104 million

unique readers

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Exact Sciences’ clinical laboratory

Capacity: 1 million tests/year

Customer service center 24/7

30,000 square feet

Highly automated

36 Exact Sciences Lab

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Cologuard workflow

Physicianorders test

Kitshipped

to patientPatient

returns kitExact lab processes

sample

Results sent to

physician

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Other

Lymphoma

Leukemia

Urinary

Breast

Genital

Respiratory

GI 145K

Source: American Cancer Society 2013, Surveillance Research

2013 Estimated U.S. Cancer Deaths

Digestive/GI cancers account for 25% of 580,000 U.S. cancer deaths

39 Source: American Cancer Society 2013, Surveillance Research

GI cancer pipeline advancingin broad collaboration with Mayo Clinic

Screening

Applied Diagnostics

Pancreas

Esophagus

Test Types Organ Focus

Colorectal

Stomach

U.S. Average World-Class Organizations EXAS 2014

30%

63%

92%

Exact Sciences’ people: our most valuable asset

Percent of engaged employees compared to benchmarks

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Exact Sciences Summary

• Cologuard® FDA-approved and launched with focused plan

• 120-person sales force and growing

• CMS proposes national coverage with 3-year testing interval

• Mayo Clinic is first system to adopt Cologuard

• Multibillion-dollar global opportunity

• Cash balance of $235 million at 6/30/14

Thank You