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Diagnostics for the early detection
and prevention of colon cancer
Cowen and Company
35th Annual Health Care Conference
March 3, 2015
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 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
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 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
1
OUR FIRST MISSION
To partner with healthcare providers,
payers, patients and advocacy
groups to help eradicate colorectal
cancer
2
Exact Sciences’ Strategy
3
Clinical Laboratory
PhysiciansPatients
Advanced Cancer Diagnostics Pipeline
Mayo Clinic Collaboration
Exact Sciences 2014 Key Milestones
4
Peer-
reviewed
journal
Medicare
coverage
application
FDA
Advisory
Panel
Medicare
coverage,
coding,
payment
Cologuard
launch
Potential
FDA
approval
Preliminar
y
Medicare
coverage
Exact Sciences Delivered in 2014
5
$493
Cologuar
d
6
Grow
Cologuar
d
Develop
Pipeline
World-
Class
Service
Our Goals for 2015
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: America’s second-leading cancer killer
new U.S. cases
Colorectal
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.
8
Detection and removal of polyps prevents cancer
Pre-cancerous polyp
Stages of colon cancer
10-15
years
9
Sources: N Engl J Med 2012;366:687-96 (Zauber);
Gastro 1997;112:594-692 (Winawer)
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
10 Source: SEER 18 2004-2010
Rising cost of colorectal cancer treatment
11
2010 2015 2020
Projected
annual
treatment costs
in 2020
$20B
$14B
Source: J Natl Cancer Inst. 2011; 103:1-12 (Mariotto)
American Cancer Society goal: 80% by 2018
Colorectal
Cervical
U.S. Cancer Screening Rates
83%
65%
12 Source: ACS Cancer Prevention & Early Detection Facts & Figures 2013; Company
estimates
14m
more
screened
FPO
Cologuard: FDA-approved, non-invasive screening test
13
A powerful value proposition to physicians & patients
①Cologuard is patient friendly
②Cologuard is safe and effective
③Engagement drives patient
compliance
14
15 Source: N Engl J Med 2014;370:1287-97. DOI: 10.1056/NEJMoa1311194 (Imperiale)
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
Guideline
Under the Affordable Care Act, if USPSTF issues A/B rating
then all commercial payers must cover Cologuard
16
17
Sales & marketing strategy
PHYSICIANS
140+ person sales team
Med journal ads
Hyper-targeted digital
Direct mail/email
PATIENTS
Big-stage print
Targeted digital
Social media
Search
PAYERS
CMS reimbursement
Managed care team
Compelling cost-
effectiveness data
6% of PCPs have been visited at least
once by a sales rep (~16,000)
Reach of Current Sales Force
6%
Not visited Visited
18
~280,000 Primary
Care Providers
Expanding the Sales Force
19
~80 reps
Oct 2014 By end of 2015
~200 reps
19
Mar 2015
~140 reps
Medicare
43%
Commercial
Insurance
40%
Medicaid
4%
Military
2%
Uninsured
10%
Reimbursement Efforts Focused on Commercial Insurance
Insurance Coverage
(U.S., 50+)
20
Sources: US Census Bureau, 2012 estimate; AIS Directory of Healthplans: 2014;
Kaiser Family Foundation 2014; Company Analysis
Areas of Focus
• States with coverage
mandates: IL,GA, MO,
MD, KY, ME, RI,AK
• Health plans affiliated
with health systems
Key Fourth-Quarter 2014 Cologuard Metrics
21
① 4,000+ ordering physicians
② 4,000+ test results reported
③ 75% patient compliance rate
(The number of valid test results reported divided by the number of collection kits
shipped to patients 60 or more days prior to Dec. 31, 2014)
④ $1.5 million in revenue
First-Quarter Cologuard Launch Progress
22
8/10
8/17
8/24
8/31
9/7
9/14
9/21
9/28
10/5
10/12
10/19
10/26
11/2
11/9
11/16
11/23
11/30
12/7
12/14
12/21
12/28
1/4
1/11
1/18
1/25
2/1
2/8
2/15
~10,000
42%
~12,000
physicians
enrolled
52%
ordering
Data as of 2/20/15
First-Quarter Cologuard Launch Progress
23
Total ordering physicians >6,300
First-quarter valid test results >5,200
− 4,000 completed in Q4
Data as of 2/20/15
31%
75%
28%
16%
Completed with no
compliance call
Completed after 1
compliance call
Completed after 2
compliance calls
Overall Compliance
Rate
Active Engagement Doubles Participation
Fourth-Quarter 2014
24
Compliance
doubled
Two+
calls
One
call
+
Cologuard’s Positive Effect on Compliance
Never
Screened or
DRE Only
39%
10%
Colonoscopy
51%
FIT/FOBT
Only
25
Source: Internal patient survey
Data as of December 31, 2014
49% never had
a colonoscopy
Factors for Cologuard Success 2015 and Beyond
① Expanding reach and frequency with providers
② Expanding medical education programs
• Peer-to-peer physician outreach
③ Private payor coverage and reimbursement
④ USPSTF guideline inclusion
• HEDIS quality measures
• ACA insurance coverage mandate
26
European launch of Cologuard
27
• 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
Exclusive Mayo Clinic collaboration on
early detection of GI cancers
28
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
Financials and key milestones
• $1.5 million in revenue during Q4 2014
• Cash balance of $282.8 million as of December 31, 2014
• $100-million offering closed in December 2014
• > 6,300 ordering physicians since FDA approval
29

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Cowen's 35th Annual Healthcare Conference Presentation

  • 1. Diagnostics for the early detection and prevention of colon cancer Cowen and Company 35th Annual Health Care Conference March 3, 2015
  • 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" 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 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 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 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 1
  • 3. OUR FIRST MISSION To partner with healthcare providers, payers, patients and advocacy groups to help eradicate colorectal cancer 2
  • 4. Exact Sciences’ Strategy 3 Clinical Laboratory PhysiciansPatients Advanced Cancer Diagnostics Pipeline Mayo Clinic Collaboration
  • 5. Exact Sciences 2014 Key Milestones 4 Peer- reviewed journal Medicare coverage application FDA Advisory Panel Medicare coverage, coding, payment Cologuard launch Potential FDA approval Preliminar y Medicare coverage
  • 6. Exact Sciences Delivered in 2014 5 $493 Cologuar d
  • 8. 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: America’s second-leading cancer killer new U.S. cases Colorectal 7
  • 9. 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. 8
  • 10. Detection and removal of polyps prevents cancer Pre-cancerous polyp Stages of colon cancer 10-15 years 9 Sources: N Engl J Med 2012;366:687-96 (Zauber); Gastro 1997;112:594-692 (Winawer)
  • 11. 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 10 Source: SEER 18 2004-2010
  • 12. Rising cost of colorectal cancer treatment 11 2010 2015 2020 Projected annual treatment costs in 2020 $20B $14B Source: J Natl Cancer Inst. 2011; 103:1-12 (Mariotto)
  • 13. American Cancer Society goal: 80% by 2018 Colorectal Cervical U.S. Cancer Screening Rates 83% 65% 12 Source: ACS Cancer Prevention & Early Detection Facts & Figures 2013; Company estimates 14m more screened
  • 15. A powerful value proposition to physicians & patients ①Cologuard is patient friendly ②Cologuard is safe and effective ③Engagement drives patient compliance 14
  • 16. 15 Source: N Engl J Med 2014;370:1287-97. DOI: 10.1056/NEJMoa1311194 (Imperiale)
  • 17. 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 Guideline Under the Affordable Care Act, if USPSTF issues A/B rating then all commercial payers must cover Cologuard 16
  • 18. 17 Sales & marketing strategy PHYSICIANS 140+ person sales team Med journal ads Hyper-targeted digital Direct mail/email PATIENTS Big-stage print Targeted digital Social media Search PAYERS CMS reimbursement Managed care team Compelling cost- effectiveness data
  • 19. 6% of PCPs have been visited at least once by a sales rep (~16,000) Reach of Current Sales Force 6% Not visited Visited 18 ~280,000 Primary Care Providers
  • 20. Expanding the Sales Force 19 ~80 reps Oct 2014 By end of 2015 ~200 reps 19 Mar 2015 ~140 reps
  • 21. Medicare 43% Commercial Insurance 40% Medicaid 4% Military 2% Uninsured 10% Reimbursement Efforts Focused on Commercial Insurance Insurance Coverage (U.S., 50+) 20 Sources: US Census Bureau, 2012 estimate; AIS Directory of Healthplans: 2014; Kaiser Family Foundation 2014; Company Analysis Areas of Focus • States with coverage mandates: IL,GA, MO, MD, KY, ME, RI,AK • Health plans affiliated with health systems
  • 22. Key Fourth-Quarter 2014 Cologuard Metrics 21 ① 4,000+ ordering physicians ② 4,000+ test results reported ③ 75% patient compliance rate (The number of valid test results reported divided by the number of collection kits shipped to patients 60 or more days prior to Dec. 31, 2014) ④ $1.5 million in revenue
  • 23. First-Quarter Cologuard Launch Progress 22 8/10 8/17 8/24 8/31 9/7 9/14 9/21 9/28 10/5 10/12 10/19 10/26 11/2 11/9 11/16 11/23 11/30 12/7 12/14 12/21 12/28 1/4 1/11 1/18 1/25 2/1 2/8 2/15 ~10,000 42% ~12,000 physicians enrolled 52% ordering Data as of 2/20/15
  • 24. First-Quarter Cologuard Launch Progress 23 Total ordering physicians >6,300 First-quarter valid test results >5,200 − 4,000 completed in Q4 Data as of 2/20/15
  • 25. 31% 75% 28% 16% Completed with no compliance call Completed after 1 compliance call Completed after 2 compliance calls Overall Compliance Rate Active Engagement Doubles Participation Fourth-Quarter 2014 24 Compliance doubled Two+ calls One call +
  • 26. Cologuard’s Positive Effect on Compliance Never Screened or DRE Only 39% 10% Colonoscopy 51% FIT/FOBT Only 25 Source: Internal patient survey Data as of December 31, 2014 49% never had a colonoscopy
  • 27. Factors for Cologuard Success 2015 and Beyond ① Expanding reach and frequency with providers ② Expanding medical education programs • Peer-to-peer physician outreach ③ Private payor coverage and reimbursement ④ USPSTF guideline inclusion • HEDIS quality measures • ACA insurance coverage mandate 26
  • 28. European launch of Cologuard 27 • 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
  • 29. Exclusive Mayo Clinic collaboration on early detection of GI cancers 28 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
  • 30. Financials and key milestones • $1.5 million in revenue during Q4 2014 • Cash balance of $282.8 million as of December 31, 2014 • $100-million offering closed in December 2014 • > 6,300 ordering physicians since FDA approval 29