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 Presentation
September 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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CologuardTM
Crosswalk
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 patients
Included 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 strategy
Drivedemand
Provider
• 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%Internist
s94%Family
Practitioners
92%
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 PCPs
Medical 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 campaign
8 million impression
s 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 patient
Patient returns kit
Exact 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