Making earlier cancer detection a routine part of medical care - February 2022
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Making earlier cancer
detection a routine part
of medical care
February 2022
EXACT SCIENCES
1
Safe harbor
This presentation contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs or strategies regarding the
future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and
unknown risks and uncertainties that could cause actual results, conditions and events to differ materially from those anticipated. Therefore, you
should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we
make regarding expected future operating results; expectations for development of new or improved products and services; our strategies,
positioning, resources, capabilities and expectations for future events or performance; and the anticipated benefits of our acquisitions, including
estimated synergies and other financial impacts.
EXACT SCIENCES
2
We aim to eradicate cancer and the
suffering it causes through tests that
help prevent cancer, detect it earlier,
EXACT SCIENCES and guide treatment.
3
We’re making earlier cancer detection a routine
part of medical care to help eradicate the disease
OUR TEAM OUR FLAGSHIP TESTS THE LEADER IN DIAGNOSTICS
450+ ~4M
Powerful commercial engine, deep
relationships, broad foundation
R&D team members people tested in 2021
1,400+ Attacking cancer through early
detection, starting with screening
person commercial team
90+ Targeting largest markets across the
country presence continuum totaling $60B+
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4Broad scientific expertise and capabilities
Expertise at every step 10 R&D centers & labs globally
DNA preservation
Proprietary sample prep TARDIS
TARgeted DIgital Sequencing
Methylation conversion
DNA methylation
DNA mutation
Protein
Sequencing
PCR
AI/machine learning
Bioinformatics
Note: includes 2 R&D centers/labs in Madison, Wisconsin
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5The foundation and brands to enable strong
revenue growth and path to profitability in 2024
Total revenue growth 2018 to 2021 $1.767B 2021 revenue by business Y/Y growth
CAGR 55%+
Screening
$1.491B
$1.062B 30%
Precision Oncology
$876M $561.7M 28%
COVID-19 testing
$454M
$143.1M (39)%
Total
2018 2019 2020 2021
Note: 2019 includes partial year of Precision Oncology revenue due to Genomic Health acquisition closing in
$1.767B 18%
Nov. 2019; profitability target is estimate for full-year adjusted EBITDA
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6Strong fourth quarter revenue across the business,
in line with pre-announcement
Q4 2021 Q4 2020
Revenue $474M $466M
Screening $278M $250M
Precision Oncology $149M $118M
COVID testing $47M $99M
Gross margin 70% 74%
Non-GAAP gross margin 75% 79%
Adjusted EBITDA -$122M $88M
Ending cash balance $1,030M $1,840M
Non-GAAP gross margin excludes amortization of acquisition-related intangibles;
Please refer to the tables in the associated press release labeled Non-GAAP Gross Profit and Non-GAAP Gross Margin and EBITDA and Adjusted EBITDA Reconciliations;
Ending cash balance includes cash, cash equivalents, and marketable securities; revenue totals do not foot due to rounding
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7Expecting ~$2 billion in 2022 revenue
Q1 2022 2022
Total $449M - 469M $1,975M - 2,027M
Screening $284M - 294M $1,340M - 1,367M
Cologuard $275M - 285M $1,300M - 1,325M
PreventionGenetics $9M $40M - 42M
Precision Oncology $140M - 145M $595M - 610M
COVID testing $25M - 30M $40M - 50M
Exact Sciences guidance provided February 22, 2022;
Cologuard revenue includes an immaterial amount of revenue from Biomatrica products
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8Making earlier cancer detection
possible at every step
DIAGNOSIS RECURRENCE
TUMOR BURDEN
RELAPSE
HEREDITARY SCREENING & PROGNOSIS/ MINIMAL RECURRENCE THERAPY
CANCER SURVEILLANCE THERAPY GUIDANCE RESIDUAL DISEASE MONITORING SELECTION
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9We plan to lead 3 of the largest patient
impact opportunities in diagnostics
Colorectal cancer Multi-cancer Minimal residual disease
screening early detection and recurrence monitoring
stool & liquid biopsy liquid biopsy liquid biopsy
110M 135M 12M
people in U.S. people in U.S. annual testing opportunities
$18B $25B $15B
Source: U.S. Census data, Exact Sciences estimates; includes U.S. markets only
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10Pipeline goals over next 18 months
support progress in key programs
Colorectal cancer Multi-cancer Minimal residual disease
screening early detection and recurrence monitoring
Cologuard 2.0 case control Feasibility data Tumor-informed data
Colon blood case control Clinical validation data Tumor-naive data
BLUE-C prospective readout Finalize test design Initiate additional studies
Submit to FDA Begin prospective study
Launch LDT to generate evidence
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11Addressing the persistent
colorectal cancer problem
151K 53K 46M
new U.S. diagnoses U.S. deaths people unscreened
Source: American Cancer Society Cancer Facts & Figures 2022, U.S. Census data,
Division of Cancer Prevention and Control, Centers for Disease Control and
Prevention (2021), Exact Sciences estimates
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12
12Cologuard is an innovative solution
94%
Early-stage cancer sensitivity*
Easy to use No preparation No time off work
Non-invasive No sedation 24/7 customer support
For adults 45 years or older and at average risk
*For stage I and II cancers; 92% sensitivity overall, 87% specificity
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Source: Imperiale TF et al., N Engl J Med (2014) 13
13Cologuard is having
a meaningful impact
7.5M+
people screened since launch
240K 35K
pre-cancerous early-stage
polyps detected cancers detected
Source: based on extrapolation of findings in DeeP-C pivotal trial population to the 7.5M+
people screened with Cologuard since launch; Imperiale TF et al., N Engl J Med (2014)
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14Investments will fuel growth
and help close the screening gap
Progress since launch Screening revenue since launch Future growth drivers
263K 850
providers have ordered field sales reps
200+ $220M
health systems with connections 2022 revenue from rescreens
~50% $100M
electronic ordering rate 2022 revenue from 45-49 age group
2015 2016 2017 2018 2019 2020 2021 Note: revenue targets are estimates for revenue
generated from Cologuard rescreens and
Screening revenue includes an immaterial amount of revenue from Biomatrica products Cologuard use in the 45-49 age group during 2022
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15Setting the bar higher with
an even better Cologuard
Improve false positive rate
Improve pre-cancer detection rate
Early Product Case-control Prospective FDA FDA Key Insurance
research development data study submission approval guidelines coverage
Note: Cologuard 2.0 has not been cleared or approved by the FDA – goals for test performance described here
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16Providing another option to get
screened with a blood test
Provide another option for
46M unscreened patients
Make available through
current screening platform
Internal case-control data
exceeds Medicare requirements
Early Product Case-control Prospective FDA FDA Key Insurance
research development data study submission approval guidelines coverage
Source: U.S. Census data, CDC NHIS survey results as published in the
CDC’s MMWR between 2006 and 2017, Exact Sciences estimates
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17Cancer remains the number 1
killer under age 85
1.9M 609K 70%
new U.S. diagnoses U.S. deaths with no screening option
Source: American Cancer Society Cancer Facts & Figures 2022,
NIH. “SEER Mortality Data, 2006-2015.” https://seer.cancer.gov/data/
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18Detect-A demonstrated the power
of multi-cancer early detection
Standard of care Standard of care
only + our test
The first and only
prospective study
25% 75% 52% 48% 10K asymptomatic
of cancers of cancers of cancers of cancers people
detected via detected via detected via detected via
SCREENING SYMPTOMS SCREENING SYMPTOMS
Doubled cancers found
compared to standard
of care alone
65% were detected
early stage
Source: A. M. Lennon et al., Science (2020)
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19Bringing together winning approaches
to lead multi-cancer early detection
Methylation Mutation Methylation + mutation
+ protein + protein + protein + others
87% 62% X%
sensitivity sensitivity sensitivity
95% 99% Y%
specificity specificity specificity
Early Product Case-control Prospective FDA FDA Key Insurance
research development data study submission approval guidelines coverage
Source: Katerov et al., AACR Cancer Research abstract nr 111 (2021),
Cohen et al., Science (2018): Vol. 359, Issue 6378, pp. 926-930
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20Precision Oncology business is a
strong platform for growth
Test reach Unmatched evidence
98% 300+
of U.S. oncologists publications
have ordered
Therapy selection
Therapy selection (large panel)
Note: oncomap also known as Oncotype MAP and oncomap ExTra also
known as GEM ExTra; updated branding will be released during 2022
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21Developing minimal residual disease and
recurrence tests to help detect cancer earlier
Problem Tumor-informed solution Tumor-naive solution
85% 90%+ 90%+
of relapses sensitivity & specificity sensitivity & specificity
caught too late
Early Product Case-control Prospective Key Insurance
research development data study guidelines coverage
90% sensitivity and specificity of TARDIS technology and methylation markers demonstrated in case-control studies: B. McDonald et al., Science Translational Medicine
(2019), H. Xie et al., Clinical Cancer Research (2020)
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22Expanding hereditary cancer testing to
help prevent & treat cancer more effectively
Customizable hereditary cancer test
Best-in-class medical geneticist team
Relationships across oncology, women’s health, urology,
gastroenterology, primary care, and health systems
Coverage and reimbursement expertise
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23We aim to eradicate cancer and the suffering it
causes through tests that help prevent cancer,
detect it earlier, and guide treatment
EXACT SCIENCES
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