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CORPORATE
PRESENTATIONJanuary 2021
© 2021. All rights reserved
Corporate Presentation I© 2021. All rights reserved
This presentation contains forward-looking statements & estimates made by the management of the Company with respect to the
anticipated future performance of MDxHealth & the market in which it operates. Such statements & estimates are based on various
assumptions & assessments of known & unknown risks, uncertainties & other factors, which were deemed reasonable when made but
may or may not prove to be correct. Actual events are difficult to predict & may depend upon factors that are beyond the Company’s
control. Therefore, actual results, the financial condition, performance or achievements of MDxHealth, or industry results, may turn out to
be materially different from any future results, performance or achievements expressed or implied by such statements & estimates. Given
these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements & estimates.
MDxHealth disclaims any obligation to update any such forward-looking statement or estimates to reflect any change in the Company’s
expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement or estimate is based,
except to the extent required by Belgian law.
Forward Looking Statement
2
Any opinions, estimates or forecasts made by analysts are theirs alone and do not represent opinions, forecasts or predictions of
MDxHealth or its management. Requests for copies of analyst reports should be directed at the respective analyst and institution.
Analyst Coverage
Corporate Presentation I
Improving prostate cancer diagnosis
via proprietary genomic technologies
Corporate Presentation I
Ticker: MDXH.BR
© 2021. All rights reserved 3
• Commercial-stage menu improves prostate cancer
diagnosis and treatment while reducing costs
• Restructuring of commercial focus has driven adoption, and
tests are included in clinical guidelines
• Proven business model with attractive gross margins and a
>$1.5B addressable U.S. market
• Proprietary menu is well protected
• New management with proven track record has driven
focus, execution and operating discipline into business for
sustainable growth
• MDxHealth is a commercial execution story and is
poised for continued growth
Corporate Presentation I© 2021. All rights reserved
Experienced Leadership Team
Proven track record of success
John Bellano
Chief Commercial Officer
Michael K. McGarrity
Chief Executive Officer
Joseph Sollee
Executive Vice President
Corp. Dev. & General Counsel
Ron Kalfus
Chief Financial Officer
Miriam Reyes
Executive Vice President
Laboratory Operations
4
Joined MDxHealth in 2019Joined MDxHealth in 2019Joined MDxHealth in 2019 Joined MDxHealth in 2011 Joined MDxHealth in 2008
Corporate Presentation I© 2021. All rights reserved
Current Challenges with Diagnosing Prostate Cancer in the U.S.
2020 ACS Surveillance Research
5
3 million elevated PSA results annually(1-2)
of biopsies do not reveal
cancer and may lead to
increased complications and
hospitalization(3-6) due to
limitation of PSA as a screen
of negative biopsies are false
negatives leading to invasive
and costly interventions(7,8)
500,000 men undergo biopsies annually
191,930
116,300
78,30062,100 60,190
PROSTATE LUNG & BRONCHUS
COLON & RECTUM
URINARY BLADDER
MELANOMA OF THE SKIN
#1 Most Common Cancer in U.S. Men1
72,500
33,33028,630 24,640
20,020
LUNG & BRONCHUS
PROSTATE COLON & RECTUM
PANCREAS LIVER & BILE DUCT
#2 Deadliest Cancer in U.S. Men1
60%
30%
Corporate Presentation I© 2021. All rights reserved
U.S. Annual Market Opportunity
6
Prostate Cancer is the Most Common Cancer in American Men
3M Men Annually
eligible for → $1.5B Market Opportunity
Who needs
a biopsy?
Who needs a
repeat biopsy?
>10% of tests
are elevated Disposition of
elevated PSA
25MPSA tests
performed
3MDemonstrate
elevated
PSA
500KProstate
biopsies
performed
200KNew prostate
cancer
cases
33KEst.
Deaths
Who needs
treatment?
~60% of biopsies
are negative
Active surveillance
or treatment
(Based on management estimates)
300K Men Annually
eligible for → $500M Market Opportunity
Corporate Presentation I© 2021. All rights reserved
MDxHealth’s Proprietary Prostate Cancer Menu
Positive
Negative
No Cancer
Cancer
Positive
Negative
Improving the decision for
initial prostate biopsy
Improving the decision for
repeat prostate biopsy
Routine
Screening
Biopsy /
Imaging
7
Clinical Pathway for Diagnosing Aggressive Prostate Cancer
Biopsy /
Imaging
Corporate Presentation I© 2021. All rights reserved
• Non-invasive urine-based “Rule-out”: improves the
diagnostic disposition of patients by avoiding approximately
half of excess prostate biopsies
• Best-in-class 95% negative predictive value3 for ruling out
clinically significant prostate cancer
• Validated potential cost savings of >$500 million to U.S.
healthcare system4
• Included in the NCCN & EAU guidelines
Improves Patient Selection Prior to Prostate Biopsy
8
The most highly predictive test to help identify men at low risk for aggressive prostate cancer
of initial biopsies do
not reveal prostate
cancer(1,2)
~ 60%
Abnormal PSA/DREBinary Actionable Results for
patient and HCP
Positive
NegativeRoutinely
Monitor
Biopsy
95% NPV
At risk for aggressive cancer?
Corporate Presentation I© 2021. All rights reserved
: Robust Clinical Evidence
12 published studies on genes and technology (> 3,500 patients)
9
Pivotal Clinical Studies
Analytical ValidationHessels et al.,
Translational Medicine Communications 2017
Clinically Validated For a 95% NPVHaese et al.,
Journal of Urology 2019
Significantly Impacts Prostate Biopsy Decision
Making
Shore et al.,
Urology Practice 2019
>$500M In Savings To Health Care SystemGovers et al.,
Journal of Urology 2018
Clinical UtilityClinical ValidityAnalytical Validity Health Economics
Corporate Presentation I© 2021. All rights reserved
• Non-invasive tissue biopsy test
• 96% Negative Predictive Value3 for clinically significant
prostate cancer
• Included in EAU and NCCN guidelines4,5
• Covered by Medicare & commercial payers
10
The only epigenetic test to identify men at risk for aggressive prostate cancer
12-core needle biopsy could miss the mark
Positive
NegativeAvoid
Rebiopsy/MRI
Rebiopsy
MRI
of men with a negative
biopsy result actually
have prostate cancer (1,2)
~30%
Negative biopsy 96% NPV3
Cancer
Biopsy Core
Needles
Prostate
Biopsy Core
Prostate
Cancer
Urethra
Field Effect
Positive
Improves Diagnostic Confidence of Biopsy Result
Corporate Presentation I© 2021. All rights reserved
: Robust Clinical Evidence
Over 55 published studies on genes and technology (> 5,500 patients)
11
Pivotal Clinical Studies
Analytical ValidationVan Neste et al.,
BMC Urology 2013
Validation of High NPVPartin et al.,
Journal of Urology 2014.
Meta Analysis Validating High NPVPartin et al.,
Trans. of the Am. Clin. and Clim. Assoc 2016.
Risk Score Development NPV 96% CS PcaVan Neste et al.
The Prostate 2016
Validated In African American MenWaterhouse et al.,
Urology 2016
Validation of Clinical Utility/Actionability Wojno., et al 2014
$500K In Savings To Health Care SystemAubry et al.,
American Health Drug and Benefits 2013
Clinical UtilityClinical ValidityAnalytical Validity Health Economics
Corporate Presentation I© 2021. All rights reserved
12
2012
PSA screening
reduced/eliminated
due to US
Preventive Services
Task Force
downgrading
ConfirmMDx is
included in the
NCCN Early
Detection of
Prostate Cancer
Guidelines
2016 2018
PSA testing resumes
due to US
Preventive Services
Task Force
upgrading
2018
MDxHealth tests
included in
European
Association of
Urology Prostate
Cancer Guidelines
2020
SelectMDx is
included in the
NCCN
Early Detection of
Prostate Cancer
Guidelines
NCCN NCCN
Clinical Guideline Inclusion
Corporate Presentation I© 2021. All rights reserved
13
SCREENING ACTIVE SURVEILLANCE (AS) InterventionDIAGNOSISPATIENT SELECTION
Active Surveillance AS monitoring
Prostate Cancer PSA Screening Test
InitialBiopsy
Low-Grade Prostate Cancer
High-grade Prostate Cancer
Intervention
Biopsy decision
AS-MDxMonitor-
MDxIntervention
Biopsy NegativeBiopsy/Imaging
Expanding Menu in the Prostate Cancer Diagnostic PathwayActive Surveillance (“watchful waiting”) requires additional diagnostic disposition
Corporate Presentation I
Low-grade prostate cancer
AS-MDx
AS-MDx
• Not all men diagnosed with localized prostate cancer benefit from intervention; some tumors are slow
growing and non-life threatening
• AS-MDx will risk-stratify patients who will benefit from immediate intervention vs. continued active
surveillance
Positive Intervention
NegativeActive
Surveillance
AS-MDx Stratifies Patients for Active Surveillance vs Intervention
134KEst. Market size
(Men Annually)
© 2021. All rights reserved14
Corporate Presentation I
Under Active Surveillance
(Low-grade cancer)
Monitor-MDx
Monitor-MDx
Positive Intervention
NegativeContinued Active
Surveillance
• Patients under active surveillance are currently monitored by invasive and costly prostate biopsies
• Monitor-MDx will be a non-invasive alternative that risk stratifies patients for continued active surveillance
vs. intervention, which may also improve patient compliance with active surveillance protocols
Monitor-MDx Validates Continued Active Surveillance
1.5MEst. Market size
(Men Annually)
© 2021. All rights reserved15
Corporate Presentation I
Strong Commercial Focus
and Presence
Leveraging direct sales force in U.S.
Driving utilization through existing U.S.
customer base
Employ OUS distribution partners for
worldwide expansion
Commercial channel opportunities
Proven Reimbursement
Strategy
ConfirmMDx covered by Medicare and
commercial payers
Recent inclusion in NCCN Guidelines will
drive coverage for SelectMDx
Executed necessary health economic and
clinical utility studies for broad insurance
coverage
Robust and Reliable
Technology
Proprietary IP portfolio capable of advancing
our diagnostic pathway in prostate cancer
World-class laboratory operations:
CAP and CLIA accredited / ISO 13485:2016
certified / NYSDOH approved
Extensive library of biomarkers and peer-
reviewed publications to apply into additional
urology and men's health diagnostics
© 2021. All rights reserved16
Corporate Presentation I© 2021. All rights reserved
MDxHealth Adoption is Broad and Accelerating
• Considerable value in the current MDxHealth menu
and customer base will drive significant revenue
growth, as adoption progresses up the S-curve
• By driving adoption through our high-quality physician
base with the current test offering, MDxHealth
anticipates continued strong reordering from this
segment as additional coverage is initiated
17
Ad
op
tio
n r
ate
>200,000 tests ordered
Diagnostic S-curve adoption model
Time
Corporate Presentation I© 2021. All rights reserved
0
20
40
60
80
100
120
2013 2014 2015 2016 2017 2018 2019 2020
ConfirmMDx Contracts SelectMDx Contracts
✓ 2016 NCCN Guidelines inclusion✓ 107 payer contracts
✓ 2020 NCCN Guidelines inclusion✓ 42 payer contracts
MDxHealth Guideline Inclusion and Managed Care Contracts
Payer Adoption
Summary
ConfirmMDx LCD(Medicare coverage)
18
ConfirmMDx and SelectMDx in EAU
ConfirmMDxin NCCN
SelectMDxin NCCN
Launch
Launch(2H14)
(1H16)
(1H18)
(2H20)
Corporate Presentation I© 2021. All rights reserved
MDxHealth is Clearly De-risked for Sustainable Growth & Value Creation
19
• Commercial execution: Best-in-class leadership and process-based focus will drive growth
• Operating discipline: Instituted through new leadership and all drivers of the P&L
• Menu expansion: Clearly defined and initiated to cement leadership position in Prostate Cancer
• Competitive position: MDxHealth is well positioned to be the ONLY company in the prostate cancer
space to take a patient through the entire diagnostic and treatment pathway, with clinically actionable
results
• Commercial channel: Established and capable of driving appropriate additional opportunities into
Urology
Straightforward commitment to drive value for
patients, customers, employees and shareholders
Corporate Presentation I© 2021. All rights reserved
U.S. Headquarters & Laboratory
15279 Alton Parkway, Ste 100
Irvine, CA 92618
United States
Global Headquarters
CAP Business Center
Rue d’Abhooz, 31
4040 Herstal, Belgium
R&D & Laboratory
Novio Tech Campus Transistorweg 5
6534 AT Nijmegen
The Netherlands
Thank You
General [email protected]
Investor Relations Contact
LifeSci Advisors, LLC (IR & PR)
US +1 949 271 9223
Global Operations
20
Corporate Presentation I© 2021. All rights reserved
ConfirmMDx
SelectMDx &ConfirmMDx
SelectMDx
Presentation References
21
SUMMARY REFERENCE CITATIONSSlide 5 – Current Challenges with Diagnosing Prostate Cancer in U.S.
1. NIH 8/20/2019 Website: https://seer.cancer.gov/statfacts/html/common.html. 2. MDxHealth management estimates 3. Moyer VA, U.S. Preventive Services Task Force. Screening for prostate cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012;157:120–134. 4. Bhindi B, Mamdani M, Kulkarni GS, et al. Impact of the U.S. Preventive Services Task Force recommendations against prostate specific antigen screening on prostate biopsy and cancer detection rates. J Urol.
2015;193:1519–1524. 5. Loeb et al. European Urology 2013. 6. Loeb et al. Journal of Urology 2011. 7. Pinsky PF et al:. BJU International 99, no. 4 (April 2007): 775–779. 8. Resnick M et al:, Urology 2011. Mar 77: 548–552
Slide 8 – SelectMDx: The most highly predictive test to help identify men at low risk for aggressive prostate cancer
1. Moyer VA, U.S. Preventive Services Task Force. Screening for prostate cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012;157:120–134. 2. Bhindi B, Mamdani M, Kulkarni GS, et al. Impact of the U.S. Preventive Services Task Force recommendations against prostate specific antigen screening on prostate biopsy and cancer detection rates. J Urol.
2015;193:1519–1524. 3. Haese, A, et al. (2019) Multicenter Optimization and Validation of a 2-Gene mRNA Urine Test for Detection of Clinically Significant Prostate Cancer Prior to Initial Prostate Biopsy. J Uro. doi:
10.1097/JU.0000000000000293; 4. Govers TM, et al. (2018) Cost-Effectiveness of Urinary Biomarker Panel in Prostate Cancer Risk Assessment. J Urol. doi: 10.1016/j.juro.2018.07.034A
Slide 10 – ConfirmMDx: The only epigenetic test to identify men at risk for aggressive prostate cancer
1. Moyer VA, U.S. Preventive Services Task Force. Screening for prostate cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012;157:120–134. 2. Bhindi B, Mamdani M, Kulkarni GS, et al. Impact of the U.S. Preventive Services Task Force recommendations against prostate specific antigen screening on prostate biopsy and cancer detection rates. J Urol.
2015;193:1519–1524. 3. Haese, A, et al. (2019) Multicenter Optimization and Validation of a 2-Gene mRNA Urine Test for Detection of Clinically Significant Prostate Cancer Prior to Initial Prostate Biopsy. J Uro. doi:
10.1097/JU.0000000000000293; 4. 2018 EAU,ESTRO,SIOG Guidelines on Prostate Cancer; 5. Govers TM, et al. (2018) Cost-Effectiveness of Urinary Biomarkernel in Prostate Cancer Risk Assessment. J Urol. doi: 10.1016/j.juro.2018.07.034A