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Corporate Presentation
December 2019
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©2019 All rights reserved.
This presentation contains forward-looking statements and estimates made by the management of the Companywith respect to the anticipated future performance of MDxHealth and the market in which it operates. Suchstatements and estimates are based on various assumptions and assessments of known and unknown risks,uncertainties and other factors, which were deemed reasonable when made but may or may not prove to becorrect. Actual events are difficult to predict and 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 impliedby such statements and estimates. Given these uncertainties, no representations are made as to the accuracy orfairness of such forward-looking statements and estimates. MDxHealth disclaims any obligation to update any suchforward-looking statement or estimates to reflect any change in the Company’s expectations with regard thereto, orany change in events, conditions or circumstances on which any such statement or estimate is based, except to theextent required by Belgian law.
Analyst coverage
Any opinions, estimates or forecasts made by analysts are theirs alone and do not represent opinions, forecasts orpredictions of MDxHealth or its management. Requests for copies of analyst reports should be directed at therespective analyst and institution.
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Forward looking statements
Delivering life changing genomic technologies to improve
the early detection of prostate cancer
§ Delivering clinically actionable information to improve patient outcomes
§ Reducing overdiagnosis and unnecessary medical costs
§ Providing an unparalleled experience for patients and physicians
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©2019 All rights reserved.
John BellanoChief Commercial Officer
Michael K. McGarrityChief Executive Officer
Over 25 years of experience in the healthcare
industry with a unique combination of device,
diagnostics and biotechnology experience
Joseph SolleeEVP Corporate Development
and General Counsel
Over 20 years of experience in private and public
molecular diagnostics, health information
technology and pharmaceuticals companies
Ron KalfusChief Financial Officer
Over 20 years of leadership experience in public and
private companies within diagnostic, biotech and
other sectors, bringing extensive knowledge in
financial operations and management
Over 20 years of experience in healthcare, playing
a crucial role in strengthening marketing efforts
driving sales, and establishing relationships with
strategic partners
Proven track record of success
Experienced leadership team
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©2019 All rights reserved.
Strong Commercial Focus and Presence
• Leveraging direct sales force in US
• Driving utilization through existing US customer base
• OUS distribution partners for worldwide expansion
Proven Reimbursement Strategy
• ConfirmMDx covered by Medicare and commercial payers
• Draft LCD for Medicare coverage for SelectMDx recently published
• Executed necessary health economic and clinical utility studies for insurance coverage
Robust and Reliable Technology
• Proprietary portfolio of biomarkers and bioinformatic technologies applicable to a wide range of diseases/indications
• World class laboratory operations
• CAP and CLIA accredited / Health Canada licensed / ISO 13485:2016 certified / NYSDOH approved
• Extensive body of peer reviewed publications
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Proven fundamental foundation driving value creation
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©2019 All rights reserved.
• ~60% of prostate biopsies do not reveal prostate cancer and may lead to complications and even hospitalization(3-6)
• ~30% false negative prostate biopsy rate leads to potentially unnecessary, invasive and costly repeat biopsies(7,8)
• Overdiagnosis and potentially unnecessary treatment for patients with indolent or no disease
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
2nd deadliest cancer among men in the US with over 2M elevated PSA results annually(1,2)
Abnormal
PSA/DRE
Treatment
Active
SurveillanceBiopsy
Positive
Negative
Active
monitoring
Challenges with standard of care for diagnosing prostate cancer
Fear of prostate cancer leads to unnecessary, invasive and costly prostate biopsy procedures
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Abnormal PSA/DRE
Positive
Negative
Biopsy
Avoid Biopsy
of initial biopsies do not reveal prostate cancer(1,2)~60%
The most highly predictive test to help identify men at risk for aggressive prostate cancer
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• Non-invasive liquid biopsy test
• 95% negative predictive value3
• High confidence rule out of need for biopsy
• Included in EAU guidelines4
• Favorable draft Medicare coverage published
• Potential cost savings of >$500m to health system5
• Potentially >14,000 quality adjusted life years gained5
Improved patient stratification prior to the initial biopsy
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 Biomarker Panel in Prostate Cancer Risk Assessment. J Urol. doi: 10.1016/j.juro.2018.07.034A
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The only epigenetic test to identify men at risk for aggressive prostate cancer
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Negative Biopsy
Positive
Negative
Repeat Biopsy
Avoid
Repeat Biopsy
• Non-invasive tissue biopsy test
• 96% negative predictive value3
• Clinically validated in >5,000 patients
• Covered by Medicare
• Awarded unique CPT code
• Included in EAU and NCCN guidelines4,5
• >55 published studies on genes and technology
• Significant potential savings to the health system6
of men with a negative biopsy results actually
have prostate cancer(1,2)~30%
Improved patient stratification to guide repeat biopsy
decision
1.Pinsky PF et al:. BJU International 99, no. 4 (April 2007): 775–779. 2. Resnick M et al:, Urology 2011. Mar 77: 548–5522. EAU Guidelines. Edn. presented at the EAU Annual Congress
Barcelona 2019. ISBN 978-94-92671-04-2. 3. Van Neste et al. Risk Score Predicts High-Grade Prostate Cancer in DNA-Methylation Positive, Histopathologically Negative Biopsies. The
Prostate 2016. 4. 2019 NCCN for Prostate Cancer Early Detection Guidelines. 5. 2018 EAU,ESTRO,SIOG Guidelines on Prostate Cancer 6. Aubry et al.; ConfirmMDx Reduces Healthcare
Costs and Helps to Differentiate Patients Who Should Undergo Repeat Biopsies. AHDB 2013.
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US market opportunity of approximately $1.8 billion
~2.8M1
Eligible US men for
SelectMDx testing
Primary Care
2M men w/abnormal PSA
Urology
300K men on
active surveillanceUrology
500K biopsies
$1.3BPotential US Market
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$500MPotential US Market
>300K2
Eligible US men for
ConfirmMDx testing
7% ConfirmMDx market
penetration
1.Lin et al., Ann Intern Med. 2008;149:192-199. 2. MDxHealth Management estimates
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Implement a targeted customer-centric model
MDxHealth’s target customer
• Treats over 500 patients
• Uses biomarker pathways/protocols
• Accepts insurance from highest value payorsU
rolo
gis
t
Focused to seize opportunityCurrent customer base
Ordering
urologists per
quarter
Urologists on a
protocol/pathway
~80% of current
volume
• Current customer base sufficient to drive significant
acceleration of revenue
• Target current urologists not on a pathway/protocol
to drive this revenue acceleration
• Clear visibility to leverage this valuable base into a
protocol/pathway
• Associated focus on managed care activities in to
these high value accounts
Focus commercial efforts on key current customers
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ConfirmMDx adoption rate position provides significant potential
Considerable value in the current ConfirmMDx
customer base to drive significant revenue growth,
getting up the S-curve
Break-even can be accomplished by driving adoption through our high quality customer base
with the current test offering
>100,000 tests
since launch
S-curve adoption model
Ad
op
tio
n r
ate
Time
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>30,000 tests
since launch
Well demonstrated market adoption
Significant market adoption channel opportunities
• Direct into well established urology customer base
• Point of care alternate site based on strategic agreement
• Primary care market
SelectMDx adoption rate position provides significant growth potential
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MDxHealth offers a comprehensive prostate cancer test menu
Stage
Development
Validation
In Market
Estimated US
market potential
Pre-Biopsy
$1B1
Re-Biopsy
$500M2
Grading
For Prostate Cancer
$430M2
Active
Surveillance
For Prostate Cancer
$300M2
Therapy
For Prostate Cancer
$700M2
Over 35 issued patents and 50 pending for prostate, bladder, kidney, cervical, colorectal, lung and brain cancer
1.Lin et al., Ann Intern Med. 2008;149:192-199. 2. MDxHealth Management estimates
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Proven fundamental foundation driving value creation
Market Validated Compelling Menu Robust and Reliable Technology
Strong Commercial Focus and Presence Proven Reimbursement Strategy
Key near-term milestones:
• Medicare coverage for SelectMDx expected in 4-6 months
• Finalization of the SelectMDx point-of-care program
• Visibility to accessing primary care market for SelectMDx
