Mdxhealth Sa · NASDAQ:MDXH
Mdxhealth Sa — Investor Presentation (December 2021)
26 slides from Mdxhealth Sa's investor presentation, December 2021
Slide 1: Corporate Presentation
December 2021 Corporate Presentation
Slide 2: Forward looking statement / Analyst coverage
Forward looking statement Analyst coverage This presentation contains forward-looking statements and estimates with respect to the anticipated future performance of Any opinions, estimates or forecasts MDxHealth and the market in which it operates. Such statements and estimates are based on assumpti
Slide 3: MDxHealth is dedicated to providing clinically actionable urologic solutions
MDxHealth is dedicated to providing highly accurate and clinically actionable urologic solutions to inform patient diagnosis and treatment while improving healthcare economics for payers and providers Ticker: MDXH Ticker: MDXH.BR © 2021 MDxHealth. All rights reserved 3 MDxHealth Corporate Presentati
Slide 4: Strategy and focus
Strategy and focus Commercial execution Payer coverage & guidelines Established commercial channel • Experienced leadership based • ConfirmMDx covered by Medicare & • Leveraging direct US urology sales force in focus and execution commercial payers • Expanding urologic menu into: • Operating discipl
Slide 5: Experienced leadership team
Experienced leadership team Track record of success Michael K. Ron John Miriam Joseph McGarrity Kalfus Bellano Reyes Sollee Chief Executive Officer Chief Financial Officer Chief Commercial Officer Executive Vice President Executive Vice President Laboratory Operations Corp. Dev. & General Counsel Jo
Slide 6: Our menu addresses a $4.6B U.S. market opportunity
Our menu addresses a $4.6B U.S. market opportunity 5 $1B $4.6B 4 $1.5B 3 $134M $500M 2 $1.5B 1 AS-MDx* Monitor-MDx* UTI TAM *In development (Based on management estimates) © 2021 MDxHealth. All rights reserved 6
Slide 7: Current challenges with diagnosing prostate cancer in the U.S.
Current challenges with diagnosing Prostate cancer is prostate cancer in the U.S. the most common Prostate cancer screening cancer and the 2nd 3 million elevated PSA results annually (1-2) deadliest cancer in U.S. men (1) 60% of biopsies DO NOT reveal cancer and may lead to increased 60% complicatio
Slide 8: $2B current U.S. prostate cancer market opportunity
$2B current U.S. prostate cancer market opportunity Who needs a Who needs a biopsy? repeat biopsy? 3M Eligible for: 300K Eligible for: 134K Elevated PSA Cancer-negative New active annually $1.5B Market $500M Market surveillance biopsies patients Out of 25M PSAs Out of 500K prostate Out of 250K new p
Slide 9: MDxHealth's proprietary prostate cancer menu
MDxHealth’s proprietary prostate cancer menu Clinical pathway for diagnosing aggressive prostate cancer Improving the decision for Improving the decision for initial prostate biopsy repeat prostate biopsy Biopsy/ Cancer Imaging Biopsy/ Imaging No Cancer Detected Routine Screening © 2021 MDxHealth. A
Slide 10: SelectMDx improves patient selection prior to prostate biopsy
SelectMDx improves patient selection prior to prostate biopsy • Non-invasive: Urine-based “rule-out” test A highly predictive test to identify men at low risk for improves the diagnostic disposition of patients by avoiding unnecessary prostate aggressive prostate cancer biopsies • Accurate: 95% nega
Slide 11: ConfirmMDx improves diagnostic confidence of biopsy result
ConfirmMDx improves diagnostic confidence of biopsy result • Non-invasive: “Rule-out” test performed on The only epigenetic test to identify men at risk for previous biopsy tissue • Accurate: 96% Negative Predictive Value for aggressive prostate cancer aggressive prostate cancer (1) • Validated: Ove
Slide 12: Evolution and catalysts of revenue growth
Evolution and catalysts of revenue growth Medicare NCCN EAU 100+ Payer Launch Coverage Guidelines Guidelines Contracts 2012 2014 2016 2018 2020 2021 Launch EAU NCCN Draft Medicare Guidelines Guidelines LCD © 2021 MDxHealth. All rights reserved 12
Slide 13: Expanding menu in the prostate cancer diagnostic pathway
Expanding menu in the prostate cancer diagnostic pathway Active surveillance and “watchful waiting” require additional diagnostic disposition Screening Patient selection Diagnosis Active Surveillance (AS) Intervention Biopsy negative Biopsy/ imaging Prostate cancer Low-grade Initial Monitor- PSA scr
Slide 14: AS-MDx to stratify patients for active surveillance
AS-MDx to stratify patients for active surveillance AS-MDx Low-grade prostate cancer 134K Not all men diagnosed with localized prostate cancer benefit Est. market size from intervention; many tumors (men annually) are slow-growing and non-life threatening AS-MDx will risk-stratify patients who will
Slide 15: Monitor-MDx to validate continued active surveillance
Monitor-MDx to validate continued active surveillance Monitor-MDx Under active surveillance (Low-grade cancer) 1.5M Patients under active surveillance are currently Est. market size monitored by invasive (men annually) and costly prostate biopsies Monitor-MDx will be a non- invasive alternative that
Slide 16: U.S. Urinary Tract Infection (UTI) annual market opportunity
U.S. Urinary Tract Infection (UTI) annual market opportunity Long Term Care UTIs are the most common outpatient infection(1) 10% Urology • 10 million suspected UTI cases present annually(2) 20% • 20% of volume presents to urology* The current UTI testing market is underserved • Current standard is b
Slide 17: Our broad urology-focused menu provides opportunity for growth
Our broad urology-focused menu provides opportunity for growth $4.6B $1B UTI Pathnostics MicrogenDX $1.5B Monitor-MDx* $134M AS-MDx* Exact Sciences Myriad Veracyte $500M ConfirmMDx Hologic $1.5B SelectMDx OPKO Biotechne Beckman Coulter * In development (Based on management estimates) © 2021 MDxHealt
Slide 18: Statement of profit or loss
Statement of profit or loss USD in thousands 6 months ended 6 months ended Revenue (unaudited) June 30, 2021 June 30, 2020 % Change Approximately 97% attributable to services and 3% to licenses and royalties SelectMDx test volume 7,051 6,485 9% ConfirmMDx represents over 90% of ConfirmMDx test volum
Slide 19: MDxHealth is well-positioned for sustainable growth
Large total addressable market 01 Selling clinically actionable diagnostic tests to urologists represents a multi-billion-dollar addressable market opportunity MDxHealth is well-positioned for Existing products provide foundational revenue and 02 strong growth potential sustainable growth Generating
Slide 20: Thank you
Global operations U.S. headquarters & laboratory 15279 Alton Parkway, Ste 100 Irvine, CA 92618 Thank you United States Global headquarters CAP Business Center Investor relations contact Rue d’Abhooz, 31 4040 Herstal, Belgium LifeSci Advisors, LLC US +1 949 271 9223 R&D & laboratory [email protected]
Slide 21: Presentation references
Presentation references SUMMARY REFERENCE CITATIONS Slide 7 – Current challenges with diagnosing prostate cancer in U.S. Slide 11 – ConfirmMDx improves diagnostic confidence of biopsy result 1. NIH 8/20/2019 Website: https://seer.cancer.gov/statfacts/html/common.html. 1. Van Neste, et al. (2016) Ris
Slide 22: Appendix
Appendix MDxHealth Corporate Presentation22
Slide 23: SelectMDx robust clinical evidence
SelectMDx robust clinical evidence 12 published studies on genes and technology Analytical Clinical Clinical Health validity validity utility economics Pivotal clinical studies Hessels et al., Analytical validation Translational Medicine Communications 2017 Haese et al., Clinically validated for a 9
Slide 24: ConfirmMDx robust clinical evidence
ConfirmMDx robust clinical evidence Over 55 published studies on genes and technology Analytical Clinical Clinical Health validity validity utility economics Pivotal clinical studies Van Neste et al., Analytical validation BMC Urology 2013 Partin et al., Validation of high NPV Journal of Urology 201
Slide 25: SelectMDx & ConfirmMDx technology
SelectMDx & ConfirmMDx technology Combined over 65 published studies SelectMDx (1) ConfirmMDx (2) Specimen Urine Prostate tissue Science mRNA RT-PCR assay DNA Methylation Specific PCR assay Biomarkers DLX1, HOXC6 GSTP1, APC RASSF1 Clinical model combines DNA Methylation markers with established Clin
Slide 26: Prostate cancer precision diagnostics: menu and pipeline
Prostate cancer precision diagnostics: menu and pipeline Expanded Product Sample Clinical decision R&D Validation Launch coverage and name type utilization ConfirmMDx Tissue Post biopsy SelectMDx Urine Pre biopsy AS-MDx TBD Active Surveillance (AS) Monitor-MDx TBD AS Monitoring © 2021 MDxHealth. All