21
CORPORATE PRESENTATION January 2021 © 2021. All rights reserved

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Page 1: CORPORATE - MDxHealth

CORPORATE

PRESENTATIONJanuary 2021

© 2021. All rights reserved

Page 2: CORPORATE - MDxHealth

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

Page 3: CORPORATE - MDxHealth

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

Page 4: CORPORATE - MDxHealth

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

Page 5: CORPORATE - MDxHealth

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%

Page 6: CORPORATE - MDxHealth

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

Page 7: CORPORATE - MDxHealth

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

Page 8: CORPORATE - MDxHealth

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?

Page 9: CORPORATE - MDxHealth

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

Page 10: CORPORATE - MDxHealth

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

Page 11: CORPORATE - MDxHealth

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

Page 12: CORPORATE - MDxHealth

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

Page 13: CORPORATE - MDxHealth

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

Page 14: CORPORATE - MDxHealth

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

Page 15: CORPORATE - MDxHealth

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

Page 16: CORPORATE - MDxHealth

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

Page 17: CORPORATE - MDxHealth

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

Page 18: CORPORATE - MDxHealth

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)

Page 19: CORPORATE - MDxHealth

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

Page 20: CORPORATE - MDxHealth

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

[email protected]

Global Operations

20

Page 21: CORPORATE - MDxHealth

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