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CORPORATE
PRESENTATIONAugust 2020
Corporate Presentation I©2020. 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
Providing clinically actionable information
to improve patient outcomes
Improving patient care while reducing
medical costs
Providing a value-based experience for
patients, clinicians and providers
Delivering life changing genomic
technologies to improve the early
detection of prostate cancer
Corporate Presentation I
Ticker: MDXH.BR
© 2020. All rights reserved 3
©2020. All rights reservedCorporate Presentation I
Experienced Leadership Team
Proven track record of success
John BellanoChief Commercial Officer
Michael K. McGarrityChief Executive Officer
Joseph SolleeExecutive Vice President
Corp. Dev. & General Counsel
Ron KalfusChief Financial Officer
Miriam ReyesExecutive Vice President
Laboratory Operations
4
Corporate Presentation I©2020. All rights reserved
Two clinically validated, commercially established,
revenue generating diagnostic tests for prostate
cancer
Address unmet need to reduce diagnostic uncertainty,
overdiagnosis and healthcare costs by informing better
treatment decisions in prostate cancer
Scalable commercial, reimbursement and medical
infrastructure, which will drive expanded market
adoption
Novel tests are based on proprietary genetic, epigenetic
(methylation) and other molecular technologies to assist
physicians with the diagnosis of urologic cancers
Current tests have Intellectual Property protection with
comprehensive portfolio of both issued and pending patents
Investment Highlights
5
Experienced management team comprised of industry
leaders in diagnostics and life sciences, with proven track
record in commercial and operating execution
Financial leverage to drive growth into current customer
base and as well as expanded applications in the prostate
cancer clinical utility pathway
Corporate Presentation I©2020. All rights reserved
Current Challenges with Diagnosing Prostate Cancer in the U.S.
2020 ACS Surveillance Research
6
3 million elevated PSA results annually(1-2)
of biopsies do not reveal
cancer and may lead to
increased complications and
hospitalization(3-6)
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. Men
72,500
33,33028,630 24,640
20,020
LUNG & BRONCHUS
PROSTATE COLON & RECTUM
PANCREAS LIVER & BILE DUCT
#2 Deadliest Cancer in U.S. Men
60%
30%
©2020. All rights reservedCorporate Presentation I
U.S. Annual Market Opportunity
7
Prostate Cancer is the Most Common Cancer in American Men
Estimated 3M
Men eligible for → $1.5B Market Opportunity
Who needs
a biopsy?
Who needs a
repeat biopsy?
>10% of tests
are elevated
~60% of biopsies
are negative
25MPSA tests
performed
500KProstate biopsies
performed
200KNew prostate
cancer cases
3MLiving with prostate
cancer
33,350Estimated Deaths
Who needs
treatment?
Estimated 300K
Men eligible for → $500M Market Opportunity
Corporate Presentation I©2020. All rights reserved
MDxHealth’s 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
8
Clinical Pathway for Diagnosing Aggressive Prostate Cancer
Biopsy /Imaging
©2020. All rights reservedCorporate Presentation I
• Non-invasive “Rule-out”: Help improve the detection of clinically significant cancer by avoiding approximately half of excess prostate biopsies.
• 95% Negative Predictive Value3 for clinically significant prostate cancer
• Included in the NCCN & EAU guidelines4
• Cost effectiveness study demonstrated SelectMDx potential cost savings of >$500 million to U.S. health care system5 and >14,000 QALY gained5
Improved Patient Selection Prior to Prostate Biopsy
9
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/DRE
Binary Actionable Results for
patient and HCP
Positive
NegativeRoutinelyMonitor
Biopsy
95% NPV
At risk for
aggressive cancer?
©2020. All rights reservedCorporate Presentation I
: Robust Clinical Evidence
12 published studies on genes and technology (> 3,500 patients)
10
Pivotal Clinical Studies
Analytical ValidationHessels et al.,
Translational Medicine Communications 2017
>$500M In Savings To Health Care SystemGovers et al.,
Journal of Urology 2018
Clinically Validated For a 95% NPVHaese et al.,
Journal of Urology 2019
Significantly Impacts Prostate Biopsy Decision MakingShore et al., Urology Practice 2019
Clinical Utility Clinical Validity Analytical Validity Health Economics
©2020. All rights reservedCorporate Presentation I
• Non-invasive tissue biopsy test
• 96% Negative Predictive Value3 for clinically significant prostate cancer
• >55 published studies on genes and technology
• Included in EAU and NCCN guidelines4,5
• Covered by Medicare & commercial payers
• Significant potential savings to the health system
11
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
©2020. All rights reservedCorporate Presentation I
: Robust Clinical Evidence
Over 55 published studies on genes and technology (> 5,500 patients)
12
Pivotal Clinical Studies
Analytical ValidationVan Neste et al.,
BMC Urology 2013
$500K In Savings To Health Care SystemAubry et al.,
American Health Drug and Benefits 2013
Validation of Clinical Utility/Actionability Wojno., et al 2014
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
Clinical Utility Clinical Validity Analytical Validity Health Economics
Corporate Presentation I©2020. All rights reserved
13
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©2020. All rights reserved
Proven Fundamental Foundation Driving Value Creation
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
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 prostate
and additional disease states
14
Corporate Presentation I©2020. All rights reserved
MDxHealth Adoption and Reorder Rates 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
15
Ad
op
tio
n r
ate
>200,000 tests ordered
Diagnostic S-curve adoption model
Time
Corporate Presentation I©2020. All rights reserved
0
20
40
60
80
100
120
2013 2014 2015 2016 2017 2018 2019 1H20
ConfirmMDx Contracts SelectMDx Contracts
✓ 2016 NCCN Guidelines inclusion
✓ 96 payer contracts – 1H20
✓ 2020 NCCN Guidelines inclusion
✓ 33 payer contracts – 1H20
MDxHealth Guideline Inclusion and Managed Care Contracts
Payer Adoption
Summary
ConfirmMDx LCD(Medicare coverage)
16
ConfirmMDx and
SelectMDx in EAU
ConfirmMDx
in NCCN
SelectMDx
in NCCN
Launch
Launch(2H14)
(1H16)
(1H18)
(2H20)
Corporate Presentation I©2020. All rights reserved
Robust and Reliable Technology
17
• MDxHealth continues to be at the forefront of researching and understanding the link between cancer and methylation, andhow this link can be translated into meaningful molecular diagnostic tests.
• MDxHealth utilizes proprietary molecular technologies to advance cancer diagnosis and treatment. Individual DNAbiomarkers in the human body can become modified in the presence of cancer. MDxHealth’s solutions/technologiesidentify these modifications at the genetic level, improving the diagnosis and associated treatment of prostate cancer.
• MDxHealth owns or holds exclusive rights to a range of issued and pending patents in multiple countries covering thegenetic, epigenetic (methylation) and other molecular biomarkers and platform technologies.
– Comprehensive Intellectual Property portfolio as well as significant value associated with know-how and trade secrets
• MDxHealth laboratories located in Irvine, CA and Nijmegen, The Netherlands
©2020. All rights reservedCorporate Presentation I
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 Inquiriesinfo@mdxhealth.com
Investor Relations Contact
LifeSci Advisors, LLC (IR & PR)
US +1 646 597 6989
ir@mdxhealth.com
Global Operations
18
Corporate Presentation I©2020. All rights reserved
ConfirmMDx
SelectMDx &
ConfirmMDx
SelectMDx
Presentation References
19
SUMMARY REFERENCE CITATIONS
Slide 6 – 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 9 – 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. 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
Slide 11 – 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
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