Exact Sciences 2015 J.P Morgan Healthcare Conference Presentation
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Exact Sciences CEO Kevin Conroy delivers an update on the commercial launch of Cologuard and tells the Exact Sciences story at the 33rd Annual J.P. Morgan Healthcare Conference in San Francisco California. The presentation took place January 14, 2015.
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Exact Sciences 2015 J.P Morgan Healthcare Conference Presentation
- 1. Diagnostics for the early detection and prevention of colon cancer J.P. Morgan Healthcare Conference January 2015
- 2. 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. Safe Harbor Statement 1
- 3. FDA approval A milestone year 2014 2 Launch Q4: 4,000+ tests completed Medicare coverage & $493 reimbursement
- 4. OUR FIRST MISSION To partner with healthcare providers, payers, patients and advocacy groups to help eradicate colorectal cancer
- 5. 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 U.S. deaths 50,310 Colorectal 4
- 6. 5
- 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. 6
- 8. Detection and removal of polyps prevents cancer Pre-cancerous polyp Stages of colon cancer 10-15 years 7 Sources: N Engl J Med 2012;366:687-96 (Zauber); Gastro 1997;112:594-692 (Winawer)
- 9. Detecting colorectal cancer early is important 9out of 10 Diagnosed early stages (I-II) Survive 5 years 1out of 10 Diagnosed Stage IV Survive 5 years 8 Source: SEER 18 2004-2010
- 10. Rising cost of colorectal cancer treatment 9 2010 2015 2020 Projected annual treatment costs in 2020 $20B $14B Source: J Natl Cancer Inst. 2011; 103:1-12 (Mariotto)
- 11. American Cancer Society goal: 80% by 2018 Colorectal Cervical Cancer screening rates 83% 65% 10 Source: ACS Cancer Prevention & Early Detection Facts & Figures 2013; Company estimates 14m more screened
- 12. 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 ACA, if USPSTF issues A/B rating then all commercial payers must cover Cologuard 11
- 13. A powerful value proposition to physicians & patients ①Cologuard is patient friendly ②Cologuard is highly effective ③Active engagement by Exact Sciences drives patient compliance 12
- 14. FPO Cologuard: FDA-approved, non-invasive screening test 13
- 15. 14 Source: N Engl J Med 2014;370:1287-97. DOI: 10.1056/NEJMoa1311194 (Imperiale)
- 16. Physician & patient engagement team • Remove follow-up hassle from physicians • 24/7 contact center • Active patient reminders • Monthly compliance reporting to physicians 15
- 17. 16 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
- 18. Experienced, focused sales team • 100 primary care reps, expanding in first half of 2015 • 11 health system reps • Average experience 10 years 17
- 19. Key Cologuard launch metrics 18 ①Q4 2014 revenue: $1.5 million ②More than 4,000 ordering physicians ③75% patient compliance rate* *The patient compliance rate is derived from the number of valid test results reported divided by the number of collection kits shipped to patients 60 or more days prior to December 31, 2014.
- 20. Cologuard public relations 19 Active effort to raise awareness of Cologuard • Cologuard featured in more than 1,000 unique news reports • More than 3 billion media impressions
- 21. Physician enrollment & ordering increasing 20 9,800+ physicians enrolled 42% ordering Data as of December 31, 2014
- 22. Sales & marketing tactics working % of Ordering Providers % of Orders 68% 32% 51 % 49% 21 Providers converted by sales force order more frequently Sales rep visit No rep visit Sales rep visit No rep visit
- 23. 37% 26% 10% 75% Returned with no compliance call Returned after compliance call 1 Returned after compliance call 2 Overall Compliance rate Active engagement program doubles participation 75% patient compliance rate 2x 22 +
- 24. Cologuard having positive effect on screening compliance Half of Cologuard users have never had a colonoscopy Never Screened or DRE Only 39% 10% Colonoscopy 51% FIT/FOBT Only 23 Source: Internal patient survey
- 25. 24 Impact of FIT/FOBT usage on ordering behavior *High FIT/FOBT defined as ≥100 FIT/FOBT tests annually More Cologuard orders from high FIT/FOBT providers*+25%
- 26. Medicare 43% Commercial Insurance 40% Medicaid 4% Military 2% Uninsured 10% Reimbursement efforts focused on commercial insurance Insurance Coverage (U.S., 50+) 25 Sources: US Census Bureau, 2012 estimate; AIS Directory of Healthplans: 2014; Kaiser Family Foundation 2014; Company Analysis Areas of Focus • Largest national and regional commercial insurers • States with insurance mandates • Health plans affiliated with health systems
- 27. Factors for Cologuard success in 2015 and beyond 26 Expanding reach and frequency with providers 1 USPSTF guideline inclusion will drive utilization • HEDIS quality measures • ACA insurance coverage mandate 2 Enable physician ordering via EMR systems 3
- 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. Other Lymphoma Leukemia Urinary Breast Genital Respiratory GI 145K Source: American Cancer Society 2013, Surveillance Research 2013 Estimated U.S. Cancer Deaths Digestive/GI cancers account for 25% of 580,000 U.S. cancer deaths 28
- 30. Exclusive Mayo Clinic collaboration on early detection of GI cancers 29 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
- 31. Financials and key milestones • Cash balance of $211 million as of September 30, 2014 • $100-million offering closed in December 2014 • $1.5 million in revenue during Q4 2014 (unaudited) • 4,000+ ordering physicians as of December 31, 2014 • U.S. Preventive Services Task Force update • Q4 earnings call late February 30
Notas do Editor
- By remaining focused on this goal, it has been a transformative year for Exact Sciences and in the war on colon cancer
- Original goal of Exact Sciences is audacious but achievable
- While our goal is achievable, it’s not going to be easy. NOTE: Discuss total market opportunity: 80m in total screening population
- I want to share with you a story …
- Scott’s story underscores the mission of our team at Exact Sciences. He exemplifies the opportunity we have to change lives through screening.
- Why is colon cancer so preventable?
- The silver bullet to eradicating colon cancer will be early detection. NOTE: cite example of cervical cancer via the pap smear.
- As a nation, we’re facing an astronomical price tag – that’s rising dramatically – to treat colon cancer.
- Driving down costs and reaching the American Cancer Society’s goal for screening cannot happen without Cologuard.
- Cologuard is being recommended in a growing number of screening guidelines.
- The value of Cologuard cannot be overstated.
- Let me outline these three points in more detail. First, Cologuard is easy for patients to use in the privacy of their own home NOTE: Show Cologuard box here
- Also, in a robust, 10,000 patient clinic trial, it outperformed the previous leading non-invasive test in nearly every category. NOTE: compare the 92% sensitivity with colonoscopy at 90-95%
- And third, our compliance engine takes the hassle away from doctors. To put it briefly, “It’s a great and needed service.”
- To execute our commercialization plan, our sales and marketing strategy is targeting three distinct groups: doctors, patients and payers.
- To register doctors and bring large systems on board, we’ve divided our sales force into distinct groups and regions.
- As you probably saw from our press release on Monday, this strategy led to a very positive launch trajectory for Cologuard in Q4.
- Our PR campaign is also: Building awareness among key audiences; Driving traffic to our website; Starting a conversation among patients and doctors. NOTE: highlight the Cologuard discussion guide here
- These efforts are driving a consistent increase in enrollment and doctor’s ordering Cologuard. NOTE: highlight the doctor’s ordering requisition here.
- What’s also clear is that a combination of sales and marketing tactics are driving order volume.
- What truly matters from the enrollment and orders is that our active engagement is driving patient compliance.
- Our launch confirms our initial research: Having a better alternative non-invasive test doubles the number of patients willing to get screened.
- Our experience in the early launch also confirms our strategy of targeting high-prescribing FIT / FOBT doctors.
- As we talk about reimbursement, it’s important to look at the gold section of this pie chart. With Medicare final coverage determination, 43% of the eligible U.S. population is covered. Our focus is now on commercial insurers.
- Looking ahead, there are three critical points that will help shape Cologuard’s success.
- While I’ve touched on the U.S. rollout, we’re also beginning our European launch of Cologuard. NOTE: EU has triple the mortality rate versus US.
- I want to turn to our pipeline now…
- We will continue to invest in Cologuard, but Exact will be about much more than a single product. For example, we’re pushing hard…
- From an investor perspective, I also want to highlight the steps we took to strengthen our balance sheet last year. Cash balance at $211m $100m offering in December Looking ahead, we expect to host an Investor Day in late Q2.
- - We’ve had a wonderful launch - Excited about 2015 - Here are three goals for the year ahead. As Scott’s story earlier in my presentation illustrates, we are doing all of this for one reason: to help eradicate colon cancer and the other deadliest forms of cancer.