CORPORATE PRESENTATION October 2020
CORPORATE PRESENTATION
October 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 variousassumptions & 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’scontrol. Therefore, actual results, the financial condition, performance or achievements of MDxHealth, or industry results, may turn out tobe 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 ofMDxHealth 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 TeamProven 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 cancersCurrent tests have Intellectual Property protection with comprehensive portfolio of both issued and pending patents
Investment Highlights
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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
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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
116,30078,300 62,100 60,190
PROSTATE LUNG & BRONCHUS
COLON & RECTUM
URINARY BLADDER
MELANOMA OF THE SKIN
#1 Most Common Cancer in U.S. Men
72,500
33,330 28,630 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
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Prostate Cancer is the Most Common Cancer in American Men
Estimated 3MMen eligible for à $1.5B Market Opportunity
Who needs a biopsy?
Who needs arepeat biopsy?
>10% of tests are elevated
~60% of biopsies are negative
25MPSA testsperformed
500KProstate biopsies
performed
200KNew prostate cancer cases
3MLiving with prostate
cancer
33,350Estimated Deaths
Who needs treatment?
Estimated 300K
Men eligible for à $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 forinitial prostate biopsy
Improving the decision forrepeat prostate biopsy
Routine Screening
Biopsy /Imaging
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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
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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
Negative RoutinelyMonitor
Biopsy
95% NPV
At risk for aggressive cancer?
©2020. All rights reservedCorporate Presentation I
: Robust Clinical Evidence12 published studies on genes and technology (> 3,500 patients)
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Pivotal Clinical Studies
Analytical Validation Hessels et al., Translational Medicine Communications 2017
>$500M In Savings To Health Care System Govers et al., Journal of Urology 2018
Clinically Validated For a 95% NPV Haese et al., Journal of Urology 2019
Significantly Impacts Prostate Biopsy Decision Making Shore 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
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The only epigenetic test to identify men at risk for aggressive prostate cancer12-core needle biopsy could miss the mark
Positive
Negative Avoid Rebiopsy /MRI
RebiopsyMRI
of men with a negative biopsy result actually have
prostate cancer (1,2)
~30%
Negative biopsy 96% NPV3
Cancer
Biopsy CoreNeedles
Prostate
Biopsy Core
Prostate
Cancer
Urethra
Field Effect
Positive
©2020. All rights reservedCorporate Presentation I
: Robust Clinical EvidenceOver 55 published studies on genes and technology (> 5,500 patients)
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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 NPV Partin et al., Journal of Urology 2014.
Meta Analysis Validating High NPV Partin et al., Trans. of the Am. Clin. and Clim. Assoc 2016.
Risk Score Development NPV 96% CS Pca Van Neste et al. The Prostate 2016
Validated In African American Men Waterhouse 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
Expanding R&D Into the Prostate Cancer Diagnostic Pathway
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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-MDx Monitor-MDx Intervention
Biopsy Negative Biopsy/Imaging
Corporate Presentation I©2020. All rights reserved
Low-grade prostate cancer
AS-MDx
AS-MDx
Not all men diagnosed with localized prostate cancer may benefit from immediate intervention. These tumors can be slow growing and non-life threatening
AS-MDx can help identify patients at lower risk of disease that may benefit from active surveillance, versus those at higher risk who should consider immediate intervention
AS-MDx aids in the disposition of patients at higher risk for disease progression whom may benefit from immediate intervention
Positive Intervention
Negative Active Surveillance
AS-MDx: Diagnostic Patient Disposition for Active Surveillance
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134KEst. Market size (Men Annually)
Corporate Presentation I©2020. All rights reserved
Under Active Surveillance
(Low-grade cancer)
Monitor-MDx
Monitor-MDx
Patients under active surveillance are currently monitored by invasive and costly prostate biopsy procedures
• Monitor-MDx provides non-invasive risk stratification for patients under active surveillance for low grade prostate cancer
• Monitor-MDx can help reduce the risk of patients not returning for their annual assessment due to complacency or poor compliance
Positive Intervention
Negative Continued Active Surveillance
Monitor-MDx: Validates Continued Monitoring Under Active Surveillance
Monitor-MDx can help identify patients under active surveillance that have an increased risk of disease progression
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1.5MEst. Market size (Men Annually)
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
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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
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Adop
tion
rate
>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
ü 2016 NCCN Guidelines inclusionü 96 payer contracts – 1H20
ü 2020 NCCN Guidelines inclusionü 33 payer contracts – 1H20
MDxHealth Guideline Inclusion and Managed Care Contracts
Payer Adoption Summary
ConfirmMDx LCD(Medicare coverage)
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ConfirmMDx and SelectMDx in EAU
ConfirmMDxin NCCN
SelectMDxin NCCN
Launch
Launch(2H14)
(1H16)
(1H18)
(2H20)
Corporate Presentation I©2020. All rights reserved
Robust and Reliable Technology
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• MDxHealth continues to be at the forefront of researching and understanding the link between cancer and methylation,and how 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 tradesecrets
• MDxHealth laboratories located in Irvine, CA and Nijmegen, The Netherlands
©2020. All rights reservedCorporate Presentation I
U.S. Headquarters & Laboratory15279 Alton Parkway, Ste 100
Irvine, CA 92618United States
Global HeadquartersCAP Business Center
Rue d’Abhooz, 314040 Herstal, Belgium
R&D & LaboratoryNovio Tech Campus Transistorweg 5
6534 AT NijmegenThe Netherlands
Thank You
General [email protected]
Investor Relations Contact
LifeSci Advisors, LLC (IR & PR)
US +1 949 271 9223
Global Operations
21
Corporate Presentation I©2020. All rights reserved
ConfirmMDx
SelectMDx &ConfirmMDx
SelectMDx
Presentation References
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SUMMARY REFERENCE CITATIONSSlide 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 estimates3. 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 cancer1. 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
https://seer.cancer.gov/statfacts/html/common.html