EX-99.2 3 a16-1597_1ex99d2.htm EX-99.2

Exhibit 99.2

2016 J.P. Morgan Health Care Conference Kevin Conroy, Chairman and CEO January 14, 2016

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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 and 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 expected future operating results, anticipated results of our sales and marketing efforts, expectations concerning payer 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; the acceptance of our products by patients and health care providers; the amount and nature of competition from other cancer screening products and procedures; our ability to maintain regulatory approvals and comply with applicable regulations; our success establishing and maintaining collaborative and licensing arrangements; our ability to successfully develop new products; and the other risks and uncertainties described in the Risk Factors and in the 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. We have filed a registration statement, including a prospectus, with the U.S. Securities and Exchange Commission (the “SEC”) for the offering to which this communication relates. Before you invest, you should read the prospectus in that registration statement and other documents the issuer has filed with the SEC for more complete information about the issuer and this offering. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, the issuer, any underwriter, or any dealer participating in the offering will arrange to send you the prospectus if you request it by calling 877-547-6340 or 800-792-2413. 2

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Presentation overview 3

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OUR MISSION To partner with healthcare providers, payers, patients & advocacy groups to help eradicate colon cancer 4

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Source: American Cancer Society, A Cancer Journal for Clinicians 2016; all figures annual Colon cancer: America’s second deadliest cancer new diagnoses in 2015 132,700 deaths in 2015 49,700 134,490 new diagnoses 49,190 deaths 5 15,690 26,120 41,780 40,890 49,190 158,080 Esophageal Prostate Pancreas Breast Colorectal Lung Annual cancer deaths

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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 polyp Four stages of colon cancer 6

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Sources: SEER 18 2004-2010 American Cancer Society, Cancer Facts & Figures 2015; 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 7 1 out of 10 survive 5 years 60% of patients are diagnosed in stages III-IV

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8 America’s stagnant colon cancer screening rate Source: CDC NHIS survey results as published in the CDC’s MMWR between 2006 and 2015 50% 52% 59% 58% 80% 80% 2005 2008 2010 2013 2018 2020

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Cologuard: Addressing the colon cancer problem Stool DNA test: 11 biomarkers (10 DNA & 1 protein) FDA-approved & covered by Medicare List 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 & US Preventive Services Task Force draft guidelines Sources: Imperiale TF et al., N Engl J Med (2014) 9 Developed with Mayo Clinic

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*Clean colons have no need for a biopsy Sources: Imperiale TF et al., N Engl J Med (2014) Mayo Clinic Proceedings, Oct 2015 Cologuard’s performance confirmed in recent study Cancer detection 92% (60/65) 100% (10/10) Precancer detection 42% (321/757) 41% (31/76) Specificity (clean colon*) 90% (4002/4457) 93% (296/318) October 2015 March 2014 10

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11 New modeling supports Cologuard’s use every 3 years 3 years cervical cancer 3 years 2 years breast cancer Source: Clinical Colorectal Cancer, December 2015 Cologuard’s cost-effectiveness compares favorably with established screening strategies $11,313 p er QALY $15,500 per QALY $30,000 per QALY

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Exact Sciences Labs: A facility delivering results Capable of processing >1 million Cologuard tests annually 12

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Only 24/7/365 nationwide colon cancer screening network drives compliance Patients Doubling compliance through direct engagement Physicians Easing burden of colon cancer screening follow-up Payers Maintaining metrics to support 3-year adherence 71% Patient compliance* *Patient compliance rate: number of valid test results reported divided by the number of collection kits shipped to patients 60 or more days prior to December 31, 2015. 13

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A multi-billion dollar U.S. market opportunity Potential 80M-patient U.S. screening market* Total U.S. market opportunity for Cologuard $4B*** Unscreened** 24M patients 30% Colonoscopy & FOBT 32M patients 40% Cologuard 24M patients 30% *80 million average-risk, asymptomatic people ages 50-84 **Assumes unscreened decreases from 42% to 30% ***Assumes 24M people screened with Cologuard every three years with ASP of $500 14

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Three-pronged commercial strategy Physicians Patients Payers Public relations Multi-channel direct to consumer Primary care sales force Medical education Digital campaign Clinical & health publications Market access team Guidelines Targeted TV test 15

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Cologuard’s growing physician penetration Adding ~2,000 ordering physicians per month 16 *IMS data based on heart drug prescriptions August 2014 December 2015 4,100 8,300 14,700 21,000 27,000 200,000 potential Cologuard prescribers* Q1 2015 Q2 2015 Q3 2015 Q4 2015

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17 Strong customer satisfaction with Cologuard Physicians expectations met or exceeded 98% Patients rated Cologuard experience very positive 88% Sources: ZS survey conducted for Exact Sciences, n=300 Exact Sciences Laboratories patient satisfaction survey data is cumulative; n = 2,799

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Source: Imperiale TF et al., N Engl J Med (2014) Exact Sciences internal estimates based upon prevalence and detection rates from DeeP-C study Early results illustrate Cologuard’s impact Cancers potentially detected by Cologuard 104,000 Completed Cologuard tests >600 Cancers >500 Early-stage cancers 18

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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 19 4 in 10 Cologuard users never previously screened

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Completed Cologuard tests continue growing Completed Cologuard tests Guidance Guidance 2015 2016 20 4K 11K 21K 34K 38K Q4 2014 Q1 2015 Q2 2015 Q3 2015 Q4 2015 104,000 $39 - 39.5M >240,000 $90 - 100M

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Strong weekly ordering growth 21 Thanksgiving Christmas & New Years Holiday seasons impact re-orders, returned collection kits 8/10/14 8/24/14 9/7/14 9/21/14 10/5/14 10/19/14 11/2/14 11/16/14 11/30/14 12/14/14 12/28/14 1/11/15 1/25/15 2/8/15 2/22/15 3/8/15 3/22/15 4/5/15 4/19/15 5/3/15 5/17/15 5/31/15 6/14/15 6/28/15 7/12/15 7/26/15 8/9/15 8/23/15 9/6/15 9/20/15 10/4/15 10/18/15 11/1/15 11/15/15 11/29/15 12/13/15 12/27/15

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Sources: Cytyc, Digene and Exact Sciences company documents and estimates Cologuard outpacing blockbuster diagnostic launches First-year revenue 1.5x ahead of ThinPrep; 2x ahead of HPV 22 Revenue – launch year $90 – $100M Guidance $40M $33M Y2 Q0 Q1 Q2 Q3 Q4 Cologuard ThinPrep Digene's HPV

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Strong Cologuard launch trajectory Strong ordering trend Sales & marketing drove 12% monthly growth Growing customer base 2,000 new physicians per month; 27,000 total 23 Predictable re-ordering Most physicians continue consistently re-ordering Customer satisfaction Very positive Cologuard experience 9 of 10 patients Reimbursement wins Momentum grows with Anthem contract

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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; >70% patient compliance Cologuard delivering positive budget impact 24 $

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Expanding Cologuard’s coverage for relevant patients Covered, not contracted Covered, in-network contract Sources: US Census, “Health Insurance Coverage Status and Type of Coverage by Selected Characteristics: 2013” US Census, “State Characteristics: Vintage 2013” AIS Directory of Health Plans: 2015 Exact Sciences internal analysis 25 32% 34% 41% 14% 22% 15% 46% 56% 56% 2014 2015

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37.6 million covered lives, second largest insurer in U.S. Strong presence in 14 states Largest plan in 6 states Second largest plan in 4 states Anthem enters into agreements by network/region California contract signed January 2016 Seeking 5 agreements in 1H 2016 Parallel implementation of commercial pull through plan Sources: Estimate based on US Census data and enrollees AIS Directory of Health Plans: 2015 Anthem BlueCross BlueShield contract & in-network status will drive adoption 26

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Draft guidance removes “I” rating from 2008 guidelines Cologuard 3-yr: best benefits to harms of all screening options reviewed by the Task Force Final guidelines expected late 2016 Seeking inclusion in HEDIS & STARS quality metrics Support from American Cancer Society, Mayo Clinic, key interest groups & 30+ lawmakers USPSTF draft guidelines 27 Cologuard included in draft guidelines as alternative screening test

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Focusing product pipeline on targeted opportunities Lung nodules Pancreatic cancer 2H 2016 Clinical need Market opportunity blood pancreatic juice ~1.5M patients/ year* $1.0B+ $0.5B+ 600-700K patients with cysts Type of test 28 Initial data readout Sources: *Silvestri GA et al. A Bronchial Genomic Classifier for the Diagnostic Evaluation of Lung Cancer. NEJM, 2015, 373, 243-251 Tanner NT et al. Management of Pulmonary Nodules by Community Pulmonologists: A Multicenter Observational Study. Chest. 2015 Dec 1;148(6):1405-14 ** Based on Exact Sciences internal analysts 2H 2016

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Establishing a long-term growth plan 29 Cologuard Pipeline Lung nodules Pancreatic Leverage existing sales force In-licensing Co-promote Product acquisition

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30

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APPENDIX 31

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Financial highlights* *Exact Sciences has not completed preparation of its financial statements for the year. These estimates are based on preliminary, unaudited data. Actual results may differ. 32 Preliminary Q4 ‘15 revenue $14.0 – 14.5 million Preliminary FY ’15 revenue $39.0 – 39.5 million 104,000 completed Cologuard tests in 2015 27,000 cumulative ordering physicians Cash balance of $343.5 million as of Sept. 30, 2015 Q4 earnings call in February 2016

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Cologuard usage mirrors the overall screening market 33 Sources: CDC NHIS 2013 survey and BRFSS 2012 Survey. Berger et al., ACG Poster (2015) Note: CDC considers colonoscopy within 10 years and FOBT within 1 year as up-to-date. Cologuard Screening History does not involve a time component, so the FOBT usage is likely not within the past year. Not Up - to - Date 42% FOBT Alone 3% FOBT and Colonoscopy 6% Colonoscopy Alone 49% Overall US Up - to - Date with CRC Screening Never Screened 42% FOBT Alone 9% FOBT and Colonoscopy 16% Colonoscopy Alone 33% Cologuard Patients Screening History

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Cologuard potential of a primary care provider 34 200k Primary care providers actively seeing patients 50+ based on heart drug prescriptions (IMS) 400 Patients per doctor 133 Targeted Cologuard patients (33% penetration of patients) 45 Annual Cologuard tests per provider with a 3 year interval 80M Average-risk patients 50+ (US Census) With current coverage, the opportunity is ~23 tests/year

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Breakdown of current U.S. insurance market Aetna Anthem Cigna UnitedHealthcare Traditional Medicare 32% 46% Medicare 46% Commercial mercial - All others 24% Medicare Advantage 14% Military/ Medicaid 8% 35 Source: AIS Directory of Health Plans: 2015; ages 50-84

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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 best benefits to harms ratio 36

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Impact of U.S. Preventive Services Task Force CISNET modeling suggests Cologuard screening strategy is effective Source: 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). Incidence reduced by 72% over lifetime versus no screening Mortality reduced by 81% over lifetime versus no screening Median USPSTF model output for screening patients 50-85 with Cologuard every 3 years 37

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