Diagnostics for the early detection and prevention of colon cancer Jefferies 2015 Healthcare Conference June 4, 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 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. 1
OUR F R FIRST ST M MISSIO ISSION To partner with healthcare providers, payers, patients and advocacy groups to to help lp eradi radicat cate col e colorec rectal tal cancer cancer 2
Our Goals for 2015 Grow World- Develop Cologuar Class Pipeline d Service 3
Exact Sciences’ Strategy Patients Physicians Clinical Laboratory Exact Sciences 300 + Sales Force Advanced Cancer Diagnostics Pipeline 4
Colorectal cancer: America’s second-leading cancer killer Annual U.S. cancer mortality 159,260 Colorectal 50,310 40,430 132,700 39,590 29,480 new U.S. cases 14,270 4,020 Cervix Ovary Prostate Pancreas Breast Lung 5 Source: ACS Cancer Facts & Figures 2015; all figures annual
Major opportunity to improve colorectal cancer screening The most preventable, yet least prevented cancer. – Journal of the National Cancer Institute 6 Source: J Natl Cancer Inst. 2009; 101:1225-1227 (Itzkowitz)
Detection and removal of polyps prevents cancer 10-15 years Pre-cancerous polyp Stages of colon cancer Sources: N Engl J Med 2012;366:687-96 (Zauber); 7 Gastro 1997;112:594-692 (Winawer)
Detecting colorectal cancer early is important 9 out of 10 1 out of 10 Survive 5 years if Survive 5 years if Diagnosed in Stages I or II Diagnosed in Stage IV 8 Source: SEER 18 2004-2010
Rising cost of colorectal cancer treatment $ 20B Projected annual treatment costs in 2020 $ 14B 2010 2015 2020 9 Source: J Natl Cancer Inst. 2011; 103:1-12 (Mariotto)
Cologuard: FDA-approved, non-invasive screening test FPO ① Patient friendly ② Highly effective ③ Engagement drives patient compliance 10
11 Source: N Engl J Med 2014;370:1287-97. DOI: 10.1056/NEJMoa1311194 (Imperiale)
Cologuard in practice guidelines Guideline Update 2014 American Cancer Society 2009 American College of Gastroenterology* Expected U.S. Preventive Services Task Force 2015-16 Under the Affordable Care Act, if USPSTF issues A/B rating then all commercial payers must cover Cologuard 12 *Guidelines based on a previous stool DNA test developed by Exact Sciences
Cologuard Launch Priorities Increase 1 reach & frequency Physician- 2 to-physician engagement 3 Secure coverage 13
Growth of completed Cologuard tests 18,000 11,000 4,000 Q4 14 Q1 15 Q2 15 Guidance 14
Ordering physicians growing rapidly 8/10/14 8/17/14 8/24/14 8/31/14 9/7/14 15 9/14/14 9/21/14 9/28/14 10/5/14 10/12/14 10/19/14 10/26/14 11/2/14 Week beginning 11/9/14 4,100 physicians 11/16/14 11/23/14 End of Q4 11/30/14 12/7/14 12/14/14 12/21/14 12/28/14 1/4/15 1/11/15 1/18/15 1/25/15 2/1/15 2/8/15 2/15/15 physicians 2/22/15 ordering 3/1/15 8,300 3/8/15 3/15/15 3/22/15
Expansion of Exact Sciences’ sales team +160 +160 200 140 80 Launch (10/14) 3/1/15 6/1/15 Number of Sales Professionals 16
Value of Exact Lab’s Customer Care Center 71 % • Remove follow-up hassle from physicians • 24/7 contact center • Active patient compliance rate reminders 17
Coverage overview Insurance Coverage (U.S., 50+) Notable insurers Commercial since start of 2015 Insurance- Covered • Anthem Blue Cross & 18% Medicare Blue Shield 43% • Tufts Health Plan • CareFirst BlueCross BlueShield PPO Commercial Uninsured Insurance- • Excellus BCBS 10% Not Covered Military 22% Medicaid • Dean Health Plan 2% 4% 18
European launch of Cologuard • 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 19
Financial Results First Quarter 2015 Revenues $4.3 million Operating expense $36.1 million Cash utilization $37.6 million Cash balance $245 million 20
OU OUR L LUNG C NG CAN ANCER MI MISSION To help win the war against lung cancer with a simple blood test that accu curat ately d y detects ts lun ung c cancer i in i n its s earl rliest st, m most ost c curable st stage ges 21
Exact Sciences joins forces with MD Anderson • Experience developing • Leading cancer center breakthrough technologies • Proven research capabilities • Efficiency navigating regulatory approvals • Clinical trial expertise • Large diagnostic sales force • Effective advocacy engagement 22
Lung cancer: America’s leading cancer killer Annual U.S. cancer mortality [VALUE] Lung 221,200 49,700 new U.S. cases 40,560 40,730 27,540 14,180 4,100 23 Source: American Cancer Society: Cancer Facts & Figures (estimates for 2015) 23
Lung cancer: World’s leading cancer killer Annual global cancer mortality [VALUE] Lung 1,825,000 694,000 723,000 746,000 522,000 400,000 266,000 307,000 new global cases 14,270 Source: WHO GLOBOCAN Cancer Fact Sheets (estimates for 2012) 24 24
Detecting lung cancer early saves lives 0.2 out of 10 7 out of 10 Survive 5 years if Survive 5 years if Diagnosed in Stages I Diagnosed in Stage IV 25 Source: SEER 18 2004-2010
Recommending LDCT despite challenges & costs Positives that are Limitations to Sensitivity Specificity false positives LDCT screening 94% 96% 73% Costly Radiation Often harmful procedures Exposure invasive follow-up 26
Solving two large problems through a blood-based test US Patient Population Screening diagnostic for high risk smokers and 9-11M former smokers Nodules discovered via CT scan and incidentally 3M through other procedures 27
Thank you 28
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