Diagnostics for the early detection and prevention of colon cancer - - PowerPoint PPT Presentation

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Diagnostics for the early detection and prevention of colon cancer - - PowerPoint PPT Presentation

Diagnostics for the early detection and prevention of colon cancer Leerink Swann Global Health Care Conference February 2015 Safe Harbor Statement Certain statements made in this news release contain forward-looking statements within the


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Diagnostics for the early detection and prevention of colon cancer

Leerink Swann Global Health Care Conference February 2015

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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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Exact Sciences 2014 Key Milestones

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Peer reviewed journal Medicare coverage application FDA Advisory Panel Medicare coverage, coding, payment Cologuard launch Potential FDA approval Preliminary Medicare coverage

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Exact Sciences Delivered in 2014

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$493

Cologuard

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OU OUR R FI FIRS RST MISSI SSION ON

To partner with healthcare providers, payers, patients and advocacy groups to to hel elp er erad adicat icate e colorecta lorectal l can ancer cer

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136 36,8 ,830 30

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

Ovary Prostate Pancreas Breast Lung Cervix

14,270 29,480 39,590 40,430

50,310

159,260 4,020

Annual U.S. cancer mortality

Colorectal cancer: America’s second-leading cancer killer

new U.S. cases

Colorectal

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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, yet least prevented cancer.

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Detection and removal of polyps prevents cancer

Pre-cancer cancerous

  • us polyp

yp Stages ges of colon

  • n cancer

cer

10-15 years

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

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Detecting colorectal cancer early is important

9 out of 10

Su Surviv vive e 5 years s if Diagnosed in Stages I or II

1 out of 10

Su Surviv vive e 5 years s if Diagnosed in Stage IV

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Source: SEER 18 2004-2010

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Rising cost of colorectal cancer treatment

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2010 2015 2020

Projected annual treatment costs in 2020

$20B $14B

Source: J Natl Cancer Inst. 2011; 103:1-12 (Mariotto)

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American Cancer Society goal: 80% by 2018

Colorectal Cervical

U.S. Cancer Screening Rates 83% 65%

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

14m more screened

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Cologuard in practice guidelines

*Guidelines based on a previous stool DNA test developed by Exact Sciences

Up Update

Am Amer erican ican Cancer cer Socie ciety ty Am Amer erican ican College lege of Gastroen enter erology*

  • logy*

2014 U.S. . Preven entiv tive e Servi vice ces s Task k Force ce 2009 Expected 2015

Guidel eline ne

Under ACA, if USPSTF issues A/B rating then all commercial payers must cover Cologuard

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FPO

Cologuard: FDA-approved, non-invasive screening test

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A powerful value proposition to physicians & patients

①Cologuard is patient friendly ②Cologuard is highly effective ③Engagement drives patient compliance

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

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Physician & patient engagement team

  • Remove follow-up

hassle from physicians

  • 24/7 contact center
  • Active patient

reminders

  • Monthly compliance

reporting to physicians

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Sales & marketing strategy

PHYSICI ICIANS ANS

140 person sales team Med journal ads Hyper-targeted digital Direct mail/email

PATIE IENT NTS

Big-stage print Targeted digital Social media Search

PAYERS YERS

CMS reimbursement Managed care team Compelling cost- effectiveness data

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Experienced national sales team

  • 100 primary care

reps, expanding in first half of 2015

  • 11 health system

reps

  • Average experience

10 years

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Key Cologuard launch metrics (Q4 2014)

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①4,000+ ordering physicians ②Revenue: $1.5 million ③75% patient compliance rate*

*The patient compliance rate is derived from the number of valid test results reported divided by the number of collection kits shipped to patients 60 or more days prior to December 31, 2014.

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Physician enrollment & ordering increasing

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9,800+ physicians enrolled 42%

  • rdering
Data as of December 31, 2014
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Sales & marketing tactics working

% of Orderi dering ng Pro rovide viders % of Order ders

68% 68% 32% 32% 51% 49%

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Providers converted by sales force

  • rder more frequently

Sales rep visit No rep visit Sales rep visit No rep visit

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37% 26% 10% 75%

Returned with no compliance call Returned after compliance call 1 Returned after compliance call 2 Overall Compliance rate

One call Two+ calls

Active engagement doubles participation

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+ Compliance doubled

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Cologuard having positive effect on screening compliance Half of Cologuard users never had a colonoscopy

Never Screened or DRE Only 39% 10% Colonoscopy 51% FIT/FOBT Only

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Source: Internal patient survey

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Impact of FIT/FOBT usage on ordering behavior

*High FIT/FOBT defined as ≥100 FIT/FOBT tests annually

More Cologuard orders from high FIT/FOBT providers*

+25%

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Medicare 43% Commercial Insurance 40% Medicaid 4% Military 2% Uninsured 10%

Reimbursement efforts focused on commercial insurance

Insurance surance Covera erage ge (U.S., 50+)

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Sources: US Census Bureau, 2012 estimate; AIS Directory of Healthplans: 2014; Kaiser Family Foundation 2014; Company Analysis

Ar Areas s of Focu

  • cus
  • Largest national and

regional commercial insurers

  • States with insurance

mandates

  • Health plans affiliated

with health systems

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Factors for Cologuard success in 2015 and beyond

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Expanding reach and frequency with providers

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USPSTF guideline inclusion will drive utilization

  • HEDIS quality measures
  • ACA insurance coverage mandate

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Enable physician ordering via EMR systems

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European launch of Cologuard

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  • Large, addressable market
  • High colon cancer rate

(152K deaths annually)

  • Low screening rates ~20%
  • 136M people 50-75 years old
  • CE mark received

December 2014

  • Core team in place
  • Initial targets: UK, Germany,

Austria, Switzerland & Italy

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Other Lymphoma Leukemia Urinary Breast Genital Respiratory GI GI 145K K

Source: American Cancer Society 2013, Surveillance Research

2013 13 Estim imat ated ed U. U.S.

  • S. Cancer

cer Death ths

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

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Exclusive Mayo Clinic collaboration on early detection of GI cancers

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Colorectal Esophageal Pancreatic

  • Expand indication of Cologuard
  • High risk (e.g. family history, IBD)
  • 40-50 years old (long term)
  • Diagnosis of Barrett’s esophagus

(a high-risk condition for cancer)

  • Early detection of esophageal cancer
  • Diagnose pancreatic cancer earlier

and with greater accuracy

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Financials and key milestones

  • Cash balance of $211 million as of September 30, 2014
  • $100-million offering closed in December 2014
  • $1.5 million in revenue during Q4 2014 (unaudited)
  • 4,000+ ordering physicians as of December 31, 2014
  • U.S. Preventive Services Task Force update
  • Q4 earnings call February 24, 2014
  • Investor Day in June 2015

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Gr Grow w Cologuar loguard De Devel elop

  • p

Pi Pipeli peline ne World rld Class ass Se Servic vice

Our goals for 2015