20160126 smb m dx health jan groen

Molecular Diagnostic Solutions for Urologic Cancer

2016 Company Presentation

Dr. Jan Groen, President & CEO

©2016 All rights reserved


Forward Looking Statement

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.

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 & institution.

Analyst Coverage

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OUR MISSIONTo improve patient outcomes by delivering molecular

diagnostic solutions for urologic cancers.

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4

:

“MDxHealth has maintained its commitment toadvancing molecular diagnostic tests for urologicalcancers, continuing to generate data supporting itsConfirmMDx® for Prostate Cancer test, andfurthermore, recently launched its urine-based“liquid-biopsy” test, SelectMDx™ for Prostate Cancer.Frost & Sullivan believes that these two offerings cansignificantly reduce the number of men undergoingunnecessary invasive biopsy procedures, andimportantly helps avoid the associated pain, risk ofcomplications, and cost.”

Frost & Sullivan Senior Industry

Analyst, Divyaa Ravishankar,

commented:


Company HighlightsMDxHealth

Listed on Euronext

publically traded multinational

healthcare company

- Euronext

- (Ticker: MDXH.BR)

Offices

Headquarters in Irvine, CA

- Herstal, Belgium

- Nijmegen, The Netherlands

Improving diagnosis

of urological cancers with

expanding suite of products

- ConfirmMDx for Prostate

- SelectMDx for Prostate

- AssureMDx for Bladder

Market leader

in molecular diagnostics

with a focus on urology

- 2015 FY sales est.$18M

- 35,000 patients tested

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Global Incidence of

Prostate and Bladder Cancer

218,182

164,180

420,899

158,211

288,235

84,062

167,357

27,272

53,36662,380

27,5194,08520,71617,705

North America & EuropeAnnual Numbers

709,134New cases of prostate cancer

242,273New cases of bladder cancer

Annual Numbers

1. GLOBOCAN 2012 (IARC) Population forecasts were extracted from the United Nations,

World Population prospects, the 2012 revision. Numbers are computed using age-specific

rates and corresponding populations for 10 age-groups.

India Australia

New Zealand

China Latin America Asia North America Europe


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Products and TimelinesMDxHealth

R&D Validation Clinical Utility Launch

MDxHealth

Partnered

US

US & EU

US & EU

US

US

USMGMT**

*

* **

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MDxHealth Business and Product StrategyUS & EU

• Microtome

• PCR

• NGS

• Biomarkers

• Epigenetic (DNA)

• Genetic (RNA)

• Prostate

• Bladder

• Kidney

• Direct sales force

• Partnerships

• Distributors

InstrumentationTechnology &

Biomarkers

Products

(CE & LDT)Commercial

Channel

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Product Offering


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Prostate Cancer Challenges Annual Numbers

$10 billion 27,540$4 billionspent on the diagnosis

and screening of prostate cancer

spent on the treatment of prostate cancer

men die annually from prostate cancer

Projected growth prostate drug market

$4 billion

$5.7 billion

$8.7 billion

2009 2014 2019

Source: Prostate Cancer Market Snapshot: More Then Provenge, The Pink Sheet, Nov 22, 2010. Elsevier Business Intelligence Publications and Products

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Early Detection is ImportantSignificant Prostate Cancer

Men will develop prostate cancer

in their lifetime1 in 6

1 in 4Men will be diagnosed with a

false-negative biopsy

1. Taneja et al: AUA Optimal Techniques of Prostate Biopsy and Specimen Handling 2013.

2. Shen et al: J. Ultrasound Med. 2008; Jun; 27(6): 895-905

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Prostate Cancer in the United Sates

Abnormal PSA tests

Biopsy procedures

Diagnosed with PCa

Deaths

4.7 million

1.3 million

241,000

27,540

Who needs an

initial biopsy?1

Who needs a

repeat biopsy?2

Who needs

intervention?3

Biomarkers

needed

Annual Numbers

Aubry W et al:. American Health Drug and Benefits 2013.6(1): 15-24

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Who Needs a

Biopsy?

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Improve Patient Selection

for Initial Prostate BiopsyNon-invasive Liquid Biopsy Assay

RT qPCR method

Urine-based test

3 mRNA genes (HOXC3, DLX1, KLK3)

LDT under CLIA

CE marked IVD kit


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False Negative

Biopsy Challenge


Unmet Clinical Need

Prostate biopsy procedures

~1.3

million

Diagnosed with PCa

~241k

With negative biopsy

~1

million

~25% with a false negative biopsy

Aubry W et al:. American Health Drug and Benefits 2013.6(1): 15-24

Need to Improve Patient Selection for Repeat Biopsy16


Lead Product

ConfirmMDx for Prostate CancerAn LDT to Aid on the Decision for Repeat Biopsy

• RT MSP DNA Methylation assay

• Three epigenetic biomarkers

(GSTPi, RASSF1 and APC)

• LDT under CLIA

• Uses residual tissue biopsy sample

Tissue Biopsy


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CLIA

Global CommercializationExperienced Commercial Team

MDxHealth Direct & Distributors

Distributors

ISO Lab

Contract discussions with distributors

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CommercializationUS and EU

• Laboratory developed test

• Large national sales force

• Established client base

• Reimbursement experience

• Strong KOL support

• CE marked in-vitro diagnostic kits

• Direct sales

• Distributors

• Reimbursement: gov, private ins, patient

• Launched in Benelux

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MDxhealth Proven Commercial TeamMolecular Diagnostic Specialists

Sales Team:

87

Managed Care - 3

Client Services - 6US Sales Force - 37

Partnerships Sales Force - 37

Sales reps with a proven

track record

Unparalleled client serivces

Focused guideline strategy

Strategically utilizing co-marketing

partnership labs

EU Sales Force - 4

Growing international

sales force


Growing Number of Ordering Physicians

2012 2013 2014 2015

2,500+200+ 1000+ ~2000

Cumulative Ordering Urologists Since Launch

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10,000 Urologist in the US

8,500Office based urologists


2012 2013 2014 2015P

>15,000

12,300

7,000

1,100Guidance

Annual Sales VolumeMDxHealth Lead Product

• Product launched in June 2012

• >35,000 patients tested

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MDxHealth News Flow2016

Publication of SelectMDx validation study

Launch SelectMDx on US market in H1

Expansion contracts US payors

Publication of bladder cancer validation study

Launch AssureMDx in Q4

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20160126 smb m dx health jan groen

Healthcare

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