Post on 19-Feb-2017
Corporate Presentation
November 2015
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
To work with patients, payers and providers to help play a role in the
eradication of colorectal cancer
OUR FIRST MISSION
3
Source: ACS Cancer Facts & Figures 2015; all figures annual
Colon cancer: America’s second deadliest 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 deaths
132,700
deaths in 2015 49,700
4
132,700 new diagnoses in US
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 Source: SEER 18 2004-2010
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
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
7
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
8
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 & U.S. Preventive Service Task Force guidelines
Source: American Cancer Society Cancer Facts & Figures 2015. Atlanta: American Cancer Society; 2015. 9
10 Source: Zauber A, et. al. “Evaluating the Benefits and Harms of Colorectal Cancer Screening Strategies: A Collaborative Modeling Approach.” AHRQ (2015). See Appendix Tables 3(a) – 10(c).
CISNET modeling suggests Cologuard® screening strategy is effective
Incidence reduced by
72% over lifetime versus
no screening
Mortality reduced by
81% over lifetime versus
no screening
Median USPSTF model output for screening patients 50-85 with Cologuard every 3 years
11 Source: Mayo Clinic Proceedings, Oct 2015
Alaska study confirms Cologuard’s® performance
Cologuard Alaska Native
people
Cologuard Deep-C
Cancer detection
100% (10/10)
92% (60/65)
Precancer detection
41% (31/76) p=0.006
42% (321/757)
Specificity (clean colon)
93% p=0.0005 90%
12 Source: Family Medicine and Community Health 2015;3(3):2–8 2 www.fmch-journal.org DOI 10.15212/FMCH.2015.0125
Independent study shows patients prefer sDNA test
Case Western Reserve University study
Patient preference 75% of patients deemed sDNA “more
suitable” than a colonoscopy
Likely to repeat test 84% of patients would take another
sDNA test, if recommended
10 30
High-quality sales force driving Cologuard® demand
200
Sales Team on June 1
Creating a results-driven sales force
§ Average 10-years sales experience
§ Focused on high-value physicians § Real-time data guides strategy
13
Primary Care Field Force
Inside Sales Representatives
Health System Representatives
§ IRONWOOD: Strategically aligned co-promote partner with 160 sales professionals
14 Source: ZS surveys conducted for Exact Sciences Before FDA approval, awareness of stool DNA testing was measured in lieu of Cologuard awareness
Growing unaided physician awareness of Cologuard®
8%
28%
49%
0%
10%
20%
30%
40%
50%
60%
Jan 2014 Dec 2014 Oct 2015
Physicians surveyed who are familiar with Cologuard without prompting
15
World-class lab delivering results
Capable of processing more than 1 million Cologuard® tests per year
Completed Cologuard® tests continues growing
4K 11K
21K
34K >42K
Q4 Q1 Q2 Q3 Q4
16
Completed Cologuard Tests
Guidance
Aug 2014 Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep
Physicians ordering Cologuard® continues expanding
• ~21,000 ordering physicians
• Adding ~500 new physicians per week
Q4 2014 Q1 2015 Q2 2015 Q3 2015
4,100
8,300
14,700
21,000
17
18
Insurance covers Cologuard ® for majority of people ages 50-84
55% of screening population covered for Cologuard
• Medicare covers 46%
• Commercial insurance covers 9%
• Total people covered: 44 million
• In-network contracts: 35% or 28 million people
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
Growth strategy to expand coverage and contracting
Quality of Care
Cost Savings
Member Satisfaction
Compelling payer value proposition
19
NEJM publication – 92% sensitive, Medicare NCD
Easy, non-invasive test; >70% patient compliance
Cologuard® delivering positive budget impact
20 *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 September 30, 2015.
Comprehensive screening program driving compliance
73% Patient Compliance*
Physician orders
Customer outreach
Cologuard completed
Physician provided result
Increasing America’s screening population (ages 50-74)
49% screened with colonoscopy
Screening history of Cologuard® users
42% never screened before
Source: Colorectal Cancer Screening with Multi-target stool DNA-based Testing Previous Screening History of the Initial Patient Cohort, poster presented at American College of Gastroenterology's Annual Scientific Meeting (ACG 2015), Oct. 16-21, 2015
9% screened only with FIT/FOBT
21
22
Keys to Cologuard’s® future success
Ease of ordering Expanding integration with EMR systems
Insurance Focus on large commercial insurance plans
Sales execution Focusing on 21K physicians already ordering
23
Financial performance remains strong
Third Quarter 2015
Revenues $12.6 million
Operating expense $48.4 million
Cash utilization $41.5 million
Quarter-end cash balance $343.5 million