Diagnostics for the early detection and prevention of colorectal cancer.

Transcription

1 Diagnostics for the early detection and prevention of colorectal cancer. Company Presentation May 2013

2 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, 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 presentation may address the following subjects among others: statements regarding the sufficiency of our capital resources, expected operating losses, anticipated results and timing of our pivotal clinical trial, expectations concerning our ability to secure FDA approval of our Cologuard test, expected license fee revenues, 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. 1

3 Agenda Colorectal Cancer Screening Opportunity Exact Sciences Solution Commercialization New Pipeline Opportunity Financial Overview 2

4 Exact Sciences at a Glance Stool DNA screens for colorectal cancer and pre-cancerous polyps Major unmet need: Greater than $3B global opportunity Pivotal clinical study completed, seeking FDA approval Exclusive IP Gastrointestinal-focused research relationship with Mayo Clinic 3

5 Colorectal Cancer Overview The most preventable, yet least prevented cancer. Journal of the National Cancer Institute Source: J Natl Cancer Inst Sep 16, Vol. 101, Issue 118 4

6 The Colorectal Cancer Problem 143,460 new cases in U.S. 51,690 deaths in U.S. U.S. Annual Cancer Mortality 51,690 39,920 37, ,340 1,200,000 new cases worldwide 15,500 28, ,000 deaths worldwide 4,220 Cervix Ovary Prostate Pancreas Breast Colorectal Lung Source: ACS: Cancer Facts and Figures

7 The Cost of Colorectal Cancer $14B spent annually on treatment Source: J Natl.Cancer Inst. 2011; 103:1-12, Natl. Cancer Inst. Cost of Care Projections

8 Annualized Treatment Costs for Medicare Patients Approximately $142,000 per patient death Source: Mariotto, J. Natl. Cancer Institute 2011, January 19; 103 (2) ; cost data, adjusted to 2010 U.S. dollars 7

9 Addressing Adherence Issues 47% of Americans are not current for recommended screening Source: ACS Colorectal Cancer Facts & Figures

10 Late Detection = Poor Survival Odds 60% of cancers are detected late stage Sources: CA Cancer J Clin; 58: ; ACS Colorectal Cancer Facts & Figures ; AHRQ December 2007 Tech Assessment accessible at ahrq.gov 9

11 14.5 million Colorectal Screenings Annually 4.3 million 10.2 million Screening Colonoscopy Tests Avg. Risk Patients Fecal Blood (FOBT/FIT) Source: CPT/HCPCS/ICD-9 Codes by Ailerion Solutions 10

12 Available U.S. Market Most physicians not happy with FIT/FOBT >80 million average risk Americans eligible for screening, growing to 100 million by million high-risk patients, not included in opportunity Potential U.S. Market 30% Penetration >$2B 11

13 The Later the Detection, the Poorer the Survival Odds Pre-Cancerous Polyps 10 years to develop Early-Stage Cancer 1-3 years to develop Late-Stage Cancer 60% new cases detected late-stage Stage I Stage II Stage III Stage IV 1 cm 2 cm 3cm 2011 Incidence 1 48,000 41,000 38,000 31, % 94% 82% 67% 12% Five-Year Survival Rates 2 1 Frost and Sullivan, U.S. Colorectal Cancer Market ; figures rounded to the nearest thousand 2 J Natl Cancer Inst 2009;101:

14 A Convenient, Non-Invasive Solution Designed to detect cancer and precancerous polyps Non-invasive No bowel preparation No diet or medication restrictions Unlimited access, can be mailed Affordable Fast results 13

15 Multi-Target Screening Test DNA Methylation NDRG4, BMP3 DNA Mutation KRAS Quantitative DNA Beta Actin Fecal Hemoglobin FIT Single Test Result If test results positive, refer to diagnostic colonoscopy 11 biomarkers 2 multiplex DNA assays 1 ELISA assay 14

16 Cologuard performance is consistent with cervical cancer screening tests Cologuard 92% cancer detection sensitivity Pap Smear 66% >2cm pre-cancer detection sensitivity 58% 1 Pap smear pre-cancer detection sensitivity (CIN 2/3) 87% specificity 92% 1 Pap smear specificity 1 Ann Intern Med, 2000 (Nanda mean of 43 studies) For Investigational Use Only. The performance characteristics of this product have not been established. 15

17 Current Non-Invasive Test Performance FIT 1 FOBT 2 DNA 3 Blood Cancer sensitivity 66%-75% 13% 48% Pre-cancer sensitivity 20%-29% 11% 11% Specificity 95% 95% 92% 1 Gastroenterology, Aug (Morikawa), Am J Gastroenterol. 2012;107(10) (Wjikerslooth) 2 New England Journal of Medicine, Dec (Imperiale) 3 Gut (epub ahead of print publication), Feb (Church) Only prospective studies comparable to DeeP-C study. 16

18 Polyp Size & Increased Cancer Risk ~5x increase in cancer risk Muto et al., Cancer,

19 More patients screened when offered an option 69% 38% 38% FOBT 31% Colonoscopy Arch Intern Med. 2012;172(7): Colonoscopy Choice Patient compliance within 1 year 18

20 Early Adoption Targets 1 2 Large Networks Highest Prescribers Employ a high percent of U.S. physicians 2,000 physicians = 1.2 million tests/year Internal estimates 19

21 Compliance Strategy Drives Test Adoption Clinical Laboratory Physician experience Patient experience Compliance engine Education Ease of test ordering Visibility into compliance Collection kit to patient Call center Secure messaging Educational tools Reminders to patients Compliance reports to physicians 20

22 Compliance Strategy Increases Likelihood of Order 67% 82% very likely to order before hearing of compliance program very likely to order after hearing of compliance program 96% of physicians likely to prescribe Cologuard From market research with physicians describing a test with attributes like Cologuard 21

23 FIT Rapidly Penetrated 10M Test/Year Market 0.2M 3.4M FIT FIT 2004 FOBT 2010 FOBT FIT penetrated market with small investment, slight advantages Centers for Medicare & Medicaid Services Medicare Part B, CRC Screening NEJM MED 364;19 May 12, 2011 Annals of Internal Medicine A. Zauber 4 Nov

24 Reimbursement Process Coverage What insurer will pay Coding Classifies laboratory procedures CMS/FDA parallel review is major launch benefit National coverage decision (NCD) dictates mandatory Medicare coverage Private insurers motivated to cover and ACA may mandate coverage with USPSTF A/B rating Request for CMS to issue G-code upon NCD CPT code application to follow in Payment Links coverage to test value CMS payment level expected upon product launch Private insurers motivated to reimburse due to current colorectal cancer screening costs & compliance rates 23

25 Professional Society Guidelines Endorses stool DNA testing in its colorectal cancer screening guidelines Also endorsed by U.S. Multi-Society Task Force, American College of Radiology & American College of Obstetricians & Gynecologists 24

26 Exact Sciences Key Milestones December Submit 1st FDA module (manufacturing) February Submit 2nd FDA module (analytical) April Announce topline results Final FDA module Additional Milestones Data publication Medicare NCD application FDA advisory panel Potential FDA approval Potential Medicare coverage, coding & payment 25

27 Oceania Study IBD-related clinical trial Major clinical need: improved screening in 1.5M IBD patients 50% unscreened Clinical trial of ~300 IBD patients ( 8 years) 50 cases: 30 cancers, 20 high grade dysplasia 250 controls Primary endpoint cancer detection, sensitivity/specificity Crohn s Disease Mayo Clinic Preliminary Data 100% cancer sensitivity 80% pre-cancerous polyp sensitivity DDW abstract 5/12 26

28 Financial Review Q $95.5 million cash balance 3/31/2013 Continuing to invest in value creation FDA submission, data publication top priority Operations team focused on laboratory, manufacturing capacity Commercial team focused on launch readiness 27

29 Conclusion Unique, patient-friendly product to address valuable, underserved market Currently seeking FDA approval Cologuard demonstrates strong sensitivity for cancer and Pap smear levels for pre-cancer Cologuard enjoys significant performance advantages, well-tailored for most dangerous pre-cancers, repeat testing Post FDA approval commercialization strategy focused on large networks, high-volume prescribers Service offering designed to dramatically increase screening compliance, support physicians and patients Work to secure optimal reimbursement from CMS, private payors on track 28

30 Thank You