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 Jefferies 2015 Healthcare Conference June 4, 2015 Safe Harbor Statement Certain statements made in this presentation contain forward-looking statements within the meaning of


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Diagnostics for the early detection and prevention of colon cancer

Jefferies 2015 Healthcare Conference June 4, 2015

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SLIDE 2 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"
  • r 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 payor 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
  • ur 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 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 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.

Safe Harbor Statement

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OUR F R FIRST ST M MISSIO ISSION

To partner with healthcare providers, payers, patients and advocacy groups to to help lp eradi radicat cate col e colorec rectal tal cancer cancer

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Grow Cologuar d Develop Pipeline World- Class Service

Our Goals for 2015

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Exact Sciences’ Strategy

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Clinical Laboratory

Physicians Patients

Advanced Cancer Diagnostics Pipeline

Exact Sciences 300 + Sales Force

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SLIDE 6

132,700

Source: ACS Cancer Facts & Figures 2015; 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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SLIDE 7 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-cancerous polyp Stages of colon cancer

10-15 years

7 Sources: N Engl J Med 2012;366:687-96 (Zauber); Gastro 1997;112:594-692 (Winawer)
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SLIDE 9

Detecting colorectal cancer early is important

9 out of 10

Survive 5 years if Diagnosed in Stages I or II

1 out of 10

Survive 5 years if Diagnosed in Stage IV

8 Source: SEER 18 2004-2010
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SLIDE 10

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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SLIDE 11

FPO

Cologuard: FDA-approved, non-invasive screening test

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①Patient friendly ②Highly effective ③Engagement drives patient compliance

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SLIDE 12 11 Source: N Engl J Med 2014;370:1287-97. DOI: 10.1056/NEJMoa1311194 (Imperiale)
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Cologuard in practice guidelines

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

Update

American Cancer Society American College of Gastroenterology* 2014 U.S. Preventive Services Task Force 2009 Expected 2015-16

Guideline

Under the Affordable Care Act, if USPSTF issues A/B rating then all commercial payers must cover Cologuard

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Cologuard Launch Priorities

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Increase reach & frequency

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Physician- to-physician engagement

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Secure coverage

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Growth of completed Cologuard tests

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4,000 11,000 18,000 Q4 14 Q1 15 Q2 15 Guidance

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SLIDE 16 8/10/14 8/17/14 8/24/14 8/31/14 9/7/14 9/14/14 9/21/14 9/28/14 10/5/14 10/12/14 10/19/14 10/26/14 11/2/14 11/9/14 11/16/14 11/23/14 11/30/14 12/7/14 12/14/14 12/21/14 12/28/14 1/4/15 1/11/15 1/18/15 1/25/15 2/1/15 2/8/15 2/15/15 2/22/15 3/1/15 3/8/15 3/15/15 3/22/15

End of Q4 4,100 physicians

Ordering physicians growing rapidly

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8,300

  • rdering

physicians

Week beginning

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Expansion of Exact Sciences’ sales team

80 140 200 +160 +160

Launch (10/14) 3/1/15 6/1/15

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Number of Sales Professionals

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Value of Exact Lab’s Customer Care Center

  • Remove follow-up

hassle from physicians

  • 24/7 contact

center

  • Active patient

reminders

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71%

compliance rate

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Coverage overview

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Notable insurers

since start of 2015
  • Anthem Blue Cross &

Blue Shield

  • Tufts Health Plan
  • CareFirst BlueCross

BlueShield PPO

  • Excellus BCBS
  • Dean Health Plan
Medicare 43% Commercial Insurance- Covered 18% Commercial Insurance- Not Covered 22% Medicaid 4% Military 2% Uninsured 10%

Insurance Coverage

(U.S., 50+)
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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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Financial Results First Quarter 2015

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Revenues $4.3 million Operating expense $36.1 million Cash utilization $37.6 million Cash balance $245 million

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OU OUR L LUNG C NG CAN ANCER MI MISSION

To help win the war against lung cancer with a simple blood test that accu curat ately d y detects ts lun ung c cancer i in i n its s earl rliest st, m most

  • st c

curable st stage ges

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  • Leading cancer center
  • Proven research capabilities
  • Clinical trial expertise
  • Effective advocacy
engagement
  • Experience developing
breakthrough technologies
  • Efficiency navigating
regulatory approvals
  • Large diagnostic sales force

Exact Sciences joins forces with MD Anderson

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221,200

new U.S. cases

Lung

Lung cancer: America’s leading cancer killer

4,100 14,180 27,540 40,560 40,730 49,700 [VALUE]

Annual U.S. cancer mortality

Source: American Cancer Society: Cancer Facts & Figures (estimates for 2015) 23
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SLIDE 25 14,270 266,000 307,000 400,000 522,000 694,000 723,000 746,000 [VALUE]

Annual global cancer mortality

24 Source: WHO GLOBOCAN Cancer Fact Sheets (estimates for 2012)

1,825,000

new global cases

Lung

Lung cancer: World’s leading cancer killer

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7 out of 10

Survive 5 years if

Diagnosed in Stages I

0.2 out of 10

Survive 5 years if

Diagnosed in Stage IV

25 Source: SEER 18 2004-2010

Detecting lung cancer early saves lives

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Recommending LDCT despite challenges & costs

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Limitations to LDCT screening

Sensitivity

94%

Positives that are false positives

96%

Specificity

73% Often harmful invasive follow-up Costly procedures Radiation Exposure

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Solving two large problems through a blood-based test

Screening diagnostic for high risk smokers and former smokers Nodules discovered via CT scan and incidentally through other procedures

US Patient Population

3M 9-11M

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Thank you