Exact Sciences chairman and CEO Kevin Conroy delivered the company's presentation at the 2015 Baird 2015 Healthcare Conference in New York at 9:40 a.m. ET on Wednesday, Sept. 9.
An archive of the webcast is available here: http://wsw.com/webcast/baird43/register.aspx?conf=baird43&page=exas&url=http://wsw.com/webcast/baird43/exas/index.aspx
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 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. 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 payer 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 our 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 the 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 Report(s) 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.
We have filed a registration statement, including a prospectus, with the U.S. Securities and Exchange Commission (the “SEC”) for the offering to which
this communication relates. Before you invest, you should read the prospectus in that registration statement and other documents the issuer has filed
with the SEC for more complete information about the issuer and this offering. You may get these documents for free by visiting EDGAR on the SEC
website at www.sec.gov. Alternatively, the issuer, any underwriter, or any dealer participating in the offering will arrange to send you the prospectus if you
request it by calling 877-547-6340 or 800-792-2413.
2
3. To work with patients, payers and providers
to help play a role in the
eradication of colorectal cancer
OUR FIRST MISSION
3
4. Source: ACS Cancer Facts & Figures 2015; all figures annual
Colon cancer: America’s second most lethal cancer
new diagnoses in 2015
15,590
27,540
40,560 40,730
[VALUE]
158,040
Esophageal Prostate Pancreas Breast Colorectal Lung
Annual US cancer mortality
132,700
deaths in 2015
49,700
4
132,700
new diagnoses in US
5. 5
Sources: J Natl Cancer Inst. 2009; 101:1225-1227 (Itzkowitz)
N Engl J Med 2012;366:687-96 (Zauber);
Gastro 1997;112:594-692 (Winawer)
Why is colon cancer the “Most preventable, yet
least prevented form of cancer”?
Pre-cancerous polyp Four stages of colon cancer
10+
years
6. 6Source: Winawer SJ et al. N Engl J Med. 1993; 329(27):1977-1981
Zauber AG et al. N Engl J Med. 2012; 366(8): 687-696.
Colorectal cancer screening works
Incidence reduced by
90%
over 7 years versus
expected outcome
Mortality reduced by
60%
over 22 years versus
national average
7. 7Source: SEER 18 2004-2010
Detecting colorectal cancer early is important
9out of 10
Survive 5 years if
Diagnosed in Stages I or II
1out of 10
Survive 5 years if
Diagnosed in Stage IV
8. Source: CDC MMWR 2013; 64(17);464-468 (Sabatino)
But many Americans aren’t getting screened
42%
of Americans not current on
colon cancer screening
8
9. Source: J Natl Cancer Inst. 2011; 103:1-12 (Mariotto)
Rising cost of colorectal cancer treatment
2010 2015 2020
Projected annual
treatment costs
in 2020
$20B
$14B
9
10. Cologuard®
: Foundation to our success
§ FDA-approved & Medicare-covered
§ Developed in collaboration with Mayo Clinic
§ New England Journal of Medicine results:
• 92% cancer sensitivity (all stages)
• 69% high grade dysplasia sensitivity
• 87% specificity
• 94% sensitivity for stages I to II cancer
§ Included in American Cancer Society guidelines
Source: American Cancer Society Cancer Facts & Figures 2015. Atlanta: American Cancer Society; 2015.
10
11. 160
High-quality sales force driving Cologuard® demand
200
Sales Team on June 1
Creating a results-driven field force
§ Strategically aligned co-promotion partner
§ Average 10-years sales experience
§ Focused on high-value physicians
§ Real-time data guides strategy
11
14. Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun
Physicians ordering Cologuard® is rapidly expanding
14,700 ordering physicians
Adding ~500 new physicians weekly
14
15. Sources:
US Census, “Health Insurance Coverage Status and Type of Coverage by Selected Characteristics: 2013”
US Census, “State Characteristics: Vintage 2013”
AIS Directory of Health Plans: 2015
Exact Sciences internal analysis
*market share for individuals ages 50-64
Reimbursement landscape for
insured patients 50+ years of age
Medicare
46%
Commercial
Coverage for
Cologuard®
9%*
Pursuing
Coverage
45%
15
16. Growth strategy to expand coverage and contracting
Quality
of Care
Cost
Savings
Member
Satisfaction
Compelling payer value proposition
16
NEJM publication – 92%
sensitive, Medicare NCD
Easy, non-invasive test;
>70% patient compliance
Cologuard® delivering
positive budget impact
17. USPSTF guidelines promote Cologuard® use, expand
coverage
§ Draft guidelines expected 2015
§ Final rating expected 2016
17
Included in
HEDIS &
STARS quality
metrics
Commercial
insurers
follow
USPSTF
Strong incentives
for providers and
payers to promote
Cologuard
18. 18*Patient compliance rate: number of valid test results reported divided by the number of collection kits shipped to patients 60 or more days prior to June 30, 2015.
Comprehensive screening program
drives compliance
73%
Patient
Compliance*
Physician
orders
Customer
outreach
Cologuard
completed
Physician
provided
result
19. Never screened before Screened with
colonscopy only
Screened with
colonscopy and FIT/
FOBT
Screened with FIT/
FOBT only
36%36%
Source: Exact Sciences Laboratories LLC data (unpublished), n = 2,997
8%20%
19
Screening history of Cologuard® users
Increasing America’s screening population
21. Exact Sciences is committed to helping win
the war on cancer through
early detection
OUR VISION
21
22. Exact Sciences is well-positioned to
develop a blood-based lung cancer test
Scientific Capabilities Robust chemistry automation platform
Ability to Collaborate Successful collaboration with Mayo Clinic
FDA/CMS Experience Pioneered parallel review with Cologuard®
Clinical Trial Execution 10,000-patient DeeP-C clinical trial
Commercial Capability 200-person primary care sales force
22
23. 221,000
new diagnoses in US
Source: Am Cancer Soc. Cancer Facts & Figures 2015. Atlanta: American Cancer Society; 2015.
Lung Cancer: America’s leading cancer killer
15,590
27,540
40,560 40,730
[VALUE]
158,040
Esophageal Prostate Pancreas Breast Colorectal Lung
Annual US cancer mortality
Lung
23
24. Low Dose CT (LDCT) screening faces
enormous challenges and costs
Limitations
to LDCT
Sensitivity
94%
Positives nodules
that are benign
96%
Specificity
73%
Often harmful
and invasive
~$3,600 per
positive result
Radiation
exposure
Impact of
follow-up
Approved by
regulators
24Sources: N Engl J Med. 2013 May 23;368(21):1980-91. doi: 10.1056/NEJMoa1209120 (National Lung Screening Trial Research Team)
25. Bringing blood-based tests to large populations
Screening diagnostic for
high-risk smokers and
former smokers
Nodules discovered via
CT screening or
incidentally
US Patient
Population
4M
10M
25
26. Monitoring US population for nodules will
compound annually to reach more than 20M
• ~4M patients with nodules
added annually
= 4M
0
3
6
9
12
15
18
21
24
1 7
Years from Launch
Population(M)
High follow-up, high positive LDCT attrition
26
27. 27
Financial performance remains strong
Q2 revenues $8.1 million
Q2 operating expense $42.4 million
Q2 end cash balance $210.8 million
July 20, 2015
financial offering
$175 million