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Exact Sciences Corporate presentation Fourth quarter 2019

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Page 1: Corporate presentations22.q4cdn.com/877809405/files/doc_financials/2019/... · Exact Sciences 3 Third-quarter 2019 financials Revenue $218.8 million $118.3 million Completed tests

Exact Sciences

Corporate presentation

Fourth quarter 2019

Page 2: Corporate presentations22.q4cdn.com/877809405/files/doc_financials/2019/... · Exact Sciences 3 Third-quarter 2019 financials Revenue $218.8 million $118.3 million Completed tests

Exact Sciences

Safe harbor statement

2

This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities 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,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “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, marketing and patient adherence efforts, expectations concerning payer reimbursement, the anticipated results of our product development efforts and the anticipated benefits of our acquisition of Genomic Health, including estimated synergies and other financial impacts. 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 and services; the acceptance of our products and services by patients and healthcare providers; our ability to meet demand for our products and services; the willingness of health insurance companies and other payers to cover our products and services and adequately reimburse us for such products and services; the amount and nature of competition from other cancer screening and diagnostic products and services; the effects of the adoption, modification or repeal of any law, rule, order, interpretation or policy relating to the healthcare system, including without limitation as a result of any judicial, executive or legislative action; the effects of changes in pricing, coverage and reimbursement for our products and services, including without limitation as a result of the Protecting Access to Medicare Act of 2014; recommendations, guidelines and quality metrics issued by various organizations such as the U.S. Preventive Services Task Force, the American Cancer Society, and the National Committee for Quality Assurance regarding cancer screening or our products and services; our ability to successfully develop new products and services and assess potential market opportunities; our ability to effectively utilize strategic partnerships, such as through our Promotion Agreement with Pfizer, Inc., and acquisitions; our success establishing and maintaining collaborative, licensing and supplier arrangements; our ability to maintain regulatory approvals and comply with applicable regulations; expectations regarding our international expansion and opportunities; the potential effects of foreign currency exchange rate fluctuations and our efforts to hedge such effects; the possibility that the anticipated benefits from our acquisition of Genomic Health cannot be realized in full or at all or may take longer to realize than expected; the possibility that costs or difficulties related to the integration of Genomic Health’s operations will be greater than expected; the outcome of any litigation, government investigations, enforcement actions or other legal proceedings; 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.

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Exact Sciences 3

Third-quarter 2019 financials

Revenue $218.8 million $118.3 million

Completed tests 456,000 241,000

Gross margin 76% 75%

Operating expense $201.7 million $129.2 million

Cash utilization $78.9 million $36.9 million

Ending cash balance $1.2 billion $1.2 billion

Q3 2019 Q3 2018

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Exact Sciences 4

We deliver life-changing

innovations in

earlier cancer detection

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Exact Sciences

Colorectal cancer: America’s second deadliest cancer

Prostate Liver

Breast

Pancreatic

Colorectal

Lung

51,020Annual deaths

Source: American Cancer Society, Cancer Facts & Figures 2019; all figures annual

5

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Exact Sciences

Detecting colorectal cancer early is critical

9 of 10Survive 5 years

Diagnosed in Stages I or II

1 of 10Survive 5 years

Diagnosed in Stage IV

Source: SEER 18 2004-2010 – colorectal cancer statistics

6

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Exact Sciences

Cologuard: addressing the colorectal cancer challenge

Easy to use

Non-invasive

Developed with

94%Early-stage cancer sensitivity*

For adults 45 years or older and at average risk

No preparation

No sedation

No time off work

24/7 customer support

*For stage I and II cancers; 92% sensitivity overall, 87% specificity

Source: Imperiale TF et al., N Engl J Med (2014)

7

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Exact Sciences

14%

38%

67%

Impact of patient navigation service on compliance

8

FIT/FOBT1 Colonoscopy2

Phone Calls Letters 24/7 Support

Emails Texts

Sources: 1. Patient adherence over 3 years, Liang PS., et al., Am J Gastroenterol. 2016

2. Patient compliance within 1 year, Arch Intern Med 2012; 172(7):575-582 (Inadomi)

Cologuard’s compliance rate represents the cumulative completed tests from kits

shipped to patients during the 6-month period ending 12 months prior to the end of the

quarter, excluding program orders

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Exact Sciences 9

Increasing America’s screened population

Screening history of Cologuard users

40% screened with colonoscopy

12% screened only with FIT/FOBT

48%never screened before

Screening history of Cologuard users: Exact Sciences Laboratories

patient satisfaction survey, Oct. 2017-Sep. 2018, n = 5,377

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Exact Sciences

Capturing a multi-billion dollar U.S. market opportunity

106M

5.2%

U.S. screening market for Cologuard*

$18B

Market share**3Q16 3Q19

88% test volume

CAGR

456K

*Exact Sciences estimate, assuming 106 million average-risk, asymptomatic people ages 45-85, revenue per test of $500-$525,

and 3-year interval for Cologuard, **(456,000 completed tests x 4 to annualize x 3 to account for interval) / 106M

Compound annual growth rate (CAGR) from 3Q16 through 3Q19

10

68K

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Exact Sciences 11

Demand fueling strong Cologuard revenue growth

3Q16 3Q19

$218M

3Q16 – 3Q19 growth

Revenue

98% CAGR

Gross profit

118% CAGR

Total OpEx

54% CAGR

Cologuard-only compound annual growth rates (CAGR) from 3Q16 through 3Q19

$28M

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Exact Sciences 12

Impact of Cologuard

People screened since launch

3M

Early-stage

cancers detected

14KPre-cancerous

polyps detected

98K

Source: based on extrapolation of findings in DeeP-C pivotal trial population to the ~3M

screened using Cologuard since launch: Imperiale TF et al., N Engl J Med (2014)

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Exact Sciences 13

2019 Corporate Priorities

Power the Partnership

Enhance Cologuard

Advance Liquid Biopsy

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Exact Sciences 14

Power the Partnership

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Exact Sciences 15

Partnering to help screen more people

Salesforce calls on health care providers

Health system relationship-building

Shared investment in nationwide marketing campaign

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Exact Sciences 16

96%Of Cologuard patients have no

out-of-pocket cost*

In-network contracts include:

Improving access to Cologuard

*Exact Sciences estimate based on historical patient billing and impact of recently

executed network agreements

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Exact Sciences 17

Epic partnership advantages

#1 KLAS ranked

healthcare software suite

Scalable IT infrastructure

Ease of ordering

Data access

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Exact Sciences 18

Preparing for demand

Investing in people, infrastructure,

and lab capacity to support our

>40%market share goal

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Exact Sciences 19

Enhance Cologuard

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Exact Sciences 20

Evaluating real-world impact of Cologuard

150Kpatients

7years

For more information visit https://clinicaltrials.gov/ct2/show/NCT04124406?id=NCT04124406&rank=1

Initiating Voyage study to determine impact on screening, incidence, and mortality rates

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Exact Sciences

45-49 average risk

50-85

average risk

21

45-49 label expansion opportunity

Increase in U.S. screening market for

Cologuard including 45-49 age group*

$15B $18B

+19Maverage risk people

Sources: US Census data and CDC NHIS survey results as published in the CDC’s MMWR between 2006 and 2017

Exact Sciences estimate, assuming ~106 million average-risk, asymptomatic people ages 45-85, average revenue

per test of $500-$525, and 3-year interval for Cologuard

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Exact Sciences 22

Improve specificity

Increase revenue

Decrease cost of goods

Note: currently evaluating whether new biomarkers could increase specificity while maintaining sensitivity

Cologuard 2.0 is not approved by the FDA

2.0

Improving Cologuard with new markers, lab processes

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Exact Sciences 23

BLUE-C

Initiating prospective CRC screening studyIntended to establish Cologuard 2.0 performance for FDA submission

10,000 patients

Stool and blood collection

Performance validation for

Cologuard 2.0 & blood test

Note: Cologuard 2.0 is not approved by the FDA; for more information visit clinicaltrials.gov

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Exact Sciences 24

Advance Liquid Biopsy

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Exact Sciences 25

Proven partnership

10-year collaboration with Mayo

Biomarker discovery & validation

Access to samples & clinical trials

Leading researchers & clinicians

Liquid biopsy for top 15 cancers

Lung

Liver

Kidney

Bladder

Cervical

Uterine

Ovarian

Breast Esophageal

Stomach

Pancreatic

Melanoma

Lymphoma

Prostate Colorectal

New

cancer test

development

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Exact Sciences 26

Exact Sciences’ advantages

Multiple classes of biomarkers

Proprietary DNA chemistry

State-of-the-art lab

Flexible, automated platform

Regulatory expertise

Commercial scale

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Exact Sciences

Prostate Liver

Breast

Pancreatic

Colorectal

Lung

27

Liver cancer: America’s fifth deadliest cancer

31,600Annual deaths

Source: American Cancer Society, Cancer Facts & Figures 2019; all figures annual

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Exact Sciences 28

Regular liver cancer testing leads to better outcomes

6 of 10Survive 3 years

Under regular testing

3 of 10Survive 3 years

Not under regular testing

Source: Kuo, YH et al., Eur J Cancer (2010)

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Exact Sciences 29

Market opportunity in liver cancer testing

$1.5BHigh-risk Americans

3M* **

Market opportunity

*Exact Sciences estimate **Total addressable market assumes revenue per test of $500 and 3M tested annually

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Exact Sciences 30

Genomic Health combination: creating a

leading global cancer diagnostics company

Strong platform for continued growth

Best-in-class R&D and clinical organization

Unparalleled commercial scale and global infrastructure

Enhanced financial strength

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Exact Sciences 31

Addressing colorectal, breast, and prostate cancer markets

COLORECTAL, BREAST AND PROSTATE TUMORS REPRESENT ~40%

OF ALL SOLID TUMOR INCIDENCE IN THE U.S.

Annual total addressable market by indication

$15B

$3B$700M

$500M$600M $200M $20B

U.S. Average RiskColorectal

U.S. 45-49 y.o.Colorectal

U.S. Breast InternationalBreast

U.S. Prostate Other Total Cologuard &Oncotype DX

Note: Bars for U.S. Average Risk and U.S. 45-49 y.o. Colorectal Cancer not to scale.

(1) Exact Sciences estimate assuming 106 million average-risk, asymptomatic people ages 45-85, revenue per test of $500 - $525, and 3-year testing interval for Cologuard.

(2) Western Europe, Canada, and Japan. Represents ~75% of the potential opportunity.

(3) Source: Surveillance, Epidemiology, and End Results (SEER) data

(1) (1) (2)

(3)

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Exact Sciences 32

Global leader in genomic cancer diagnostics

Patients tested

>1MCountries represented

90+Breast cancer patients worldwide

with prospective outcomes

>96K

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Exact Sciences