Exact Sciences CEO Kevin Conroy's presentation slides, featuring updates on Cologuard's commercial launch, from the 2014 Baird Healthcare Conference September 4, 2014.
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Exact Sciences Company Presentation Baird Healthcare Conference
1. Diagnostics for the early detection
and prevention of colon cancer
Corporate Presentation
September 2014
2. Safe Harbor Statement
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.
1
3. OUR MISSION
To partner with healthcare providers,
payers, patients and advocacy groups
to help eradicate colorectal cancer
2
4. 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
3
6. 5
Cologuard FIT Improvement P Value
Cancer
detection
92%
(60/65)
73%
(48/65)
25% 0.002
Advanced
Adenoma
detection
42%
(321/757)
24%
(180/757)
78% <0.001
N Engl J Med 2014;370:1287-97. DOI: 10.1056/NEJMoa1311194 (Imperiale)
7. 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.
6
8. Center for Medicare & Medicaid Services Update
7
• 3-year interval proposed by CMS
• Preliminary pricing expected late Aug or Sept
• Final national coverage, pricing expected Q4
CMS
9. Proposed Cologuard reimbursement
crosswalk
CologuardTM Crosswalk Proposed Payment
2 DNA methylation
markers
8
81315
ML/RARalpha
$282.83
7 DNA mutation
markers
81275
KRAS
$197.48
Fecal hemoglobin
82274
FIT
$21.70
Total $502.01
10. 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
9
11. 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
10
12. Major opportunity to improve colorectal cancer screening
The most preventable, yet
least prevented cancer.
– Journal of the National Cancer Institute
Source: J Natl Cancer Inst. 2009; 101:1225-1227 (Itzkowitz)
11
13. Detection and removal of polyps prevents cancer1
Pre-cancerous polyp
Stages of colon cancer
10-15
years2
12
1Source: N Engl J Med 2012;366:687-96 (Zauber)
2Source Gastro 1997;112:594-692. (Winawer)
14. Colorectal cancer: the second-leading U.S. cancer killer
136,830
Annual U.S. cancer mortality
14,270
29,480
39,590
40,430
50,310
159,260
4,020
Cervix Ovary Prostate Pancreas Breast Lung
Source: ACS Cancer Facts & Figures 2014; all figures annual
new U.S. cases
50,310
U.S. deaths
Colorectal
13
15. Late-stage detection leads to poor outcomes
60%
of cancers are
detected late stage
Sources: CA Cancer J Clin 2008; 58:130-160 (Levin, B);
ACS Colorectal Cancer Facts & Figures 2011-13; seer.cancer.gov/faststats
14
16. Colorectal cancer costs significant and rising
$14B
annual treatment costs
Source: J 15 Natl Cancer Inst. 2011; 103:1-12 (Mariotto)
17. Low screening rate contributes to colorectal cancer deaths
~50%
of Americans are current for
recommended colonoscopy
screening
Source: 16 ACS Cancer Prevention & Early Detection Facts & Figures 2013
18. American Cancer Society Goal: 80% by 2018
Colorectal
Cervical
83%
65%
Cancer screening rates
17 ACS Cancer Prevention & Early Detection Facts & Figures 2013; Company estimates
19. Current U.S. screening of average-risk patients
10.2M
fecal blood tests
Source: CPT/HCPCS/ICD-9 Codes by Aileron Solutions;
Company estimates
4.3M
screening colonoscopies
14.5 million tests per year
55% FOBT
FIT 45%
18
20. Cologuard U.S. market opportunity
80M
eligible for screening
(>50 years old)
Source: Company estimates
>$2B
Potential U.S. market
30% penetration
19
21. Despite inadequacies, FIT rapidly gained market share
over FOBT
• Strategy of converting systems and high-volume users
• Insignificant sales & marketing investment
• Sensitivity advantages over FOBT
• Without compliance engine
2%
45%
2004 2008 2012
20 Sources: Company estimates and CMS, Medicare Part B, Colorectal Cancer Screening
22. Cologuard commercial strategy
21
Drive
demand
Provider • Physician & system
outreach
• Medical education
• Publications
Promote
compliance
Patient • Direct advertising
• Public relations
• Compliance engine
Secure
payment
Payer • CMS parallel review
• Managed care team
23. Cologuard launch underway
22
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
24. Highest prescribing
primary care physicians
Large networks
employing large number
of primary care physicians
Source: Company estimates
Target segmentation
23
25. Who represents our initial target physician?
98% Ob-Gyns 94% Internists
• Orders 400 FIT or FOBT tests per year
• Practices in a group setting without a GI
• Female physicians, 15% more likely to recommend Cologuard
24
Family
92% Practitioners
Receptive to recommending Cologuard
Source: Medspan research 2013; ZS Associates 2013 physician survey
26. Cologuard market research Physicians
percent of FOBT/FIT tests that would be replaced
with Cologuard by surveyed physicians 74%
Source: Medspan research 2013; ZS Associates 2013 physician survey
25
percent of physicians likely to order Cologuard
(67% very likely; 29% moderately likely) 96%
27. Cologuard market research Patients
92% of patients likely to use Cologuard
more patients likely to get screened
through compliance program 2x
26
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.
28. Cologuard Sales team
• 3 regions
• 10 large
system
/hospital reps
• 80 PCP reps
• 10 area
managers
• 6 clinical
27
liaisons
~10 years average health care sales experience
29. 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)
28
32. 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
31
TALK TO YOUR DOCTOR ABOUT COLOGUARD.
The breakthrough test for colon cancer screening that ’s as easy as going t o the bathroom,
Cologuard is ef fect ive and easy to use in t he pr ivacy of your ow n ho m e—no sp ec ial
preparat ion or t ime off w ork required. Only Cologuard uses innovat ive stool DNA technology
t o fi nd 92%* of all colon cancers, and is completely noninvasive.
Cologuard keeps screening between yo u—and your colon.
Visit CologuardTest .com to learn more.
Cologuard is int ended for the qualitat ive detect ion of colorectal neoplasia associated DNA markers and
for the presence of occult hemoglobin in human stool. A posit ive result may indicate the presence of
colorectal cancer (CRC) or advanced adenoma (AA) and should be followed by a diagnost ic colonoscopy.
Cologuard is indicated to screen adult s of either sex, 50 years or older, who are at t ypical average risk
33. 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
32
Digital
campaign
8 million
impressions
in first week
34. 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
33
35. Exact Sciences’ clinical laboratory
Capacity: 1 million tests/year
Customer service center 24/7
30,000 square feet
Highly automated
34
37. Cologuard workflow
Physician
orders test
Kit
shipped
to patient
Patient
returns kit
Exact lab
processes
sample
Results
sent to
physician
36
38. Digestive/GI cancers account for 25% of 580,000 U.S.
cancer deaths
2013 Estimated U.S. Cancer Deaths
Other
Lymphoma
Leukemia
Urinary
Breast
Genital
GI
145K
Respiratory
Source: American Cancer Society 2013, Surveillance Research
37
39. GI cancer pipeline advancing
in broad collaboration with Mayo Clinic
Test Types Organ Focus
Source: American Cancer Society 2013, Surveillance Research
Screening
Applied Diagnostics
38
Pancreas
Esophagus
Colorectal
Stomach
40. Exact Sciences’ people: our most valuable asset
Percent of engaged
employees compared
to benchmarks
30%
63%
92%
U.S. Average World-Class Organizations EXAS 2014
39
41. 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
40
The point sensitivity of Cologuard for the detection of colorectal cancer was 92.3 percent compared with 73.8 percent for FIT. This is a difference of 18.5 percentage points and is statistically significant. The point sensitivity of Cologuard for advanced adenomas was 42.4 compared with 23.8 percent for FIT. This is a difference of 18.6 percentage points and is again statistically significant.
The isolated performance of the hemoglobin immunoassay component of Cologuard was similar to that of FIT, with sensitivities of 72.3 percent and 73.8 percent, respectively, for the detection of colorectal cancer, and 22.7 percent and 23.8 percent, respectively, for the detection of advanced pre-cancerous lesions. The specificities were 94.8 percent and 94.9 percent, respectively.
Cologuard also outperformed FIT in hypothetical screening of 10,000 patients.
(Next slide…)
Most diagnostic tests have a code that corresponds to a reimbursement rate. When a code doesn’t exist for a new test like Cologuard, a new code can be crosswalked or linked to existing codes to establish payment for the new test. We were asked by CMS to use the crosswalk approach.
We were invited to present our crosswalk reimbursement proposal to CMS’ Hospital & Ambulatory Policy Group or HAPG at its annual reimbursement review last week. Our crosswalk proposal is based on codes in the 2014 Clinical Laboratory Fee Schedule. Shown here are the three Tier 1 codes that we presented in our crosswalk. These include a code that corresponds directly to our KRAS mutation markers and another that corresponds directly to our fecal hemoglobin test. Our DNA methylation markers are crosswalked to an RNA assay with a workflow similar to ours. These codes total to a proposed reimbursement for Cologuard of 502 dollars.
CMS does not provide feedback on proposals at these meetings. The next step is a preliminary pricing decision from HAPG by early September, followed by a public comment period and a final decision in November.
Taken together, the reimbursement and regulatory timeline looks like this…
(Next slide…)
Annual
So imagine what we can do with Cologuard
This is the first time we’re publicly sharing these survey data publicly.
Where does 3.5x figure come from
We have developed a technology platform that is applicable to the screening and diagnosis of other cancers. We intend to develop novel, clinically important diagnostic screening tests for GI tract cancers.
We have a broad, exclusive collaboration with Mayo Clinic on GI tract cancers. The collaboration is unique and, together, we’re developing two new kinds of tests.
As a reminder, GI cancers comprise 25 percent of all cancer deaths in the United States. First, we’re working together on tests that can screen general, asymptomatic populations for pre-cancers and cancer across the entire GI tract. Second, we’re developing new applied diagnostic tests for specific gastrointestinal cancers that would potentially be used with high-risk and symptomatic patients.
Within those two general kinds of tests, we’re focusing on colorectal, pancreatic, esophageal and stomach cancers.
At Digestive Disease Week in May, some very interesting data was presented that resulted from our collaboration. Our technology platform demonstrated 88percent sensitivity for pancreatic cancer by testing pancreatic juice for certain DNA mutations and methylations. The technology also demonstrated 100% sensitivity for detecting Barrett’s esophagus, the precursor to the vast majority of esophageal cancer.
We are continuing to make progress with our pipeline and look forward to updating you by early next year.
In conclusion…
(Next slide…)