MDxHealth SA · NASDAQ:MDXH
MDxHealth SA — Investor Presentation (October 2022)
26 slides from MDxHealth SA's investor presentation, October 2022
Slide 1: Corporate Presentation
Corporate Presentation October 2022 © 2022 mdxhealth. All rights reserved | 1
Slide 2: Forward looking statement
Forward looking statement This presentation contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs or strategies regarding Analyst coverage the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and a
Slide 3: mdxhealth provides highly accurate and clinically actionable urologic solutions
mdxhealth provides highly accurate and Ticker: MDXH clinically actionable urologic solutions to inform patient diagnosis and treatment while improving healthcare economics for payers and providers Ticker: MDXH.BR © 2022 mdxhealth. All rights reserved | 3
Slide 4: mdxhealth fundamentals for growth
mdxhealth fundamentals for growth Fundamentals in place Levers for growth • The most comprehensive menu in prostate cancer • Expansion of mdxhealth clinical pathway for prostate cancer • Robust clinical data (acquisition of Oncotype DX) • Expanding coverage of current menu (Select mdx LCD • Establis
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 Join
Slide 6: Our menu addresses a $4.8B U.S. market opportunity
Our menu addresses a $4.8B U.S. market opportunity Comprehensive Urology Menu 5 $1B $4.8B 4 $1.5B 3 $300M $500M 2 $1.5B 1 Oncotype DX Monitor mdx* Total *In development (Based on management estimates) © 2022 mdxhealth. All rights reserved | 6
Slide 7: Commercial levers to drive growth
Commercial levers to drive growth Best-in-class offering into urology with menu of the most accurate clinically-actionable tests for patients and urologists Standardized laboratory partner for urology group practice • One rep Acquired August 2022 • One laboratory • One patient support program • ONE
Slide 8: Current challenges with diagnosing prostate cancer
Prostate cancer is the Current challenges with most common cancer diagnosing prostate cancer and the 2nd deadliest cancer in U.S. men (1) Prostate cancer screening 3 million elevated PSA results annually (1-2) 60% 60% of biopsies DO NOT reveal cancer and may lead to increased complications and hospi
Slide 9: Expanding menu in the prostate cancer diagnostic pathway
Expanding menu in the prostate cancer diagnostic pathway The most comprehensive menu in prostate cancer Screening Patient Selection Diagnosis Active Surveillance Intervention Cancer-negative Biopsy/MRI Biopsy Prostate cancer Localized Active Monitor mdx* screening Biopsy Prostate Cancer Surveillance
Slide 10: Select mdx improves patient selection prior to prostate biopsy
improves patient selection prior to prostate biopsy • Non-invasive: Urine-based “rule-out” test improves the diagnostic disposition of patients by A highly predictive test to identify men at avoiding unnecessary prostate biopsies low risk for aggressive prostate cancer • Accurate: 95% negative predi
Slide 11: Confirm mdx improves diagnostic confidence of biopsy result
improves diagnostic confidence of biopsy result • Non-invasive: “Rule-out” test performed on previous biopsy tissue The only epigenetic test to identify men • Accurate: 96% Negative Predictive Value for aggressive prostate cancer (1) at risk for aggressive prostate cancer • Validated: Over 55 publis
Slide 12: Oncotype DX Genomic Prostate Score guides treatment decisions
Oncotype DX Genomic Prostate Score (GPS) guides treatment decisions for localized prostate cancer The test analyzes prostate cancer gene activity to predict disease aggressiveness and provide clinically meaningful endpoints (1-23) • Non-invasive: test performed on previous biopsy tissue • Accurate:
Slide 13: Prostate cancer pipeline
Prostate cancer pipeline Active surveillance monitoring (Localized prostate cancer) 1.5M Est. market size (men annually) Monitor mdx Monitor mdx will be a non-invasive alternative that risk-stratifies Patients under active patients for continued active surveillance are currently surveillance vs. int
Slide 14: Urinary Tract Infection (UTI) annual market opportunity
Urinary Tract Infection (UTI) annual market opportunity Long Term Care Urology UTIs are the most common outpatient infection(1) 10% 20% • 10 million suspected UTI cases present annually(2) • 20% of volume presents to urology* The current UTI testing market is underserved • Current standard is based
Slide 15: Resolve mdx: Advanced molecular urinary tract infection testing
: Advance molecular urinary tract infection testing • Non-invasive: Urine-based test that provides personalized antibiotics options for urinary • As many as 33% of urine cultures are polymicrobial, especially in elderly tract infections. populations, and traditional urine culture may miss up to 67%
Slide 16: mdxhealth is well-positioned for sustainable growth
Large total addressable market Selling clinically-actionable diagnostic tests to urologists 01 represents a multi-billion-dollar addressable market opportunity mdxhealth is 02 Broad menu provides sustainable growth potential Generating revenue from clinically-proven commercial products; growth to oc
Slide 17: Thank you
Thank you Investor relations contact Global operations LifeSci Advisors, LLC US headquarters & laboratory EU headquarters US +1 949 271 9223 15279 Alton Parkway, Ste 100 CAP Business Center [email protected] Irvine, CA 92618 Rue d’Abhooz, 31 United States 4040 Herstal, Belgium TX laboratory R&D & lab
Slide 18: References
References Slide 8 – 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 T
Slide 19: References
References Slide 12 – Oncotype DX Genomic Prostate Score (GPS) to guide treatment decisions for analysis. Urol Pract. 2015; 2(6), 343-348. localized prostate cancer 13. Albala D, et al. Health economic impact and prospective clinical utility of Oncotype DX® Genomic Prostate Score. Rev Urol. 2016;18(
Slide 20: References
References Slide 16 – U.S. Urinary Tract Infection (UTI) annual market opportunity 1. Medina M, Castillo-Pino E. An introduction to the epidemiology and burden of urinary tract infections. Ther Adv Urol. 2019;11:1756287219832172. Published 2019 May 2. doi:10.1177/1756287219832172. 2. Flores-Mireles
Slide 21: Appendix
Appendix © 2022 mdxhealth. All rights reserved | 21
Slide 22: Select mdx robust clinical evidence
Select mdx 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
Slide 23: Confirm mdx robust clinical evidence
Confirm mdx 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 20
Slide 24: Oncotype DX robust clinical evidence
Oncotype DX robust clinical evidence Over 20 published clinical validation and utility studies Analytical Clinical Clinical Health validity validity utility economics Pivotal clinical studies Analytical validation Knezevic et al., 2013 Clinically validated as an Klein et al., 2014, Cullen et al., 20
Slide 25: Select mdx, Confirm mdx and Oncotype DX technology
Select mdx, Confirm mdx and Oncotype DX technology The most comprehensive menu in prostate cancer Select mdx (1) Confirm mdx (2) Oncotype DX (3) Specimen Urine Prostate tissue Localized PCa tissue Science mRNA RT-PCR assay DNA Methylation Specific PCR assay Multi gene expression RT-PCR Assay 17 gene
Slide 26: Prostate cancer precision diagnostics: menu and pipeline
Prostate cancer precision diagnostics: menu and pipeline Product Sample Expanded coverage Clinical decision R&D Validation Launch name type and utilization Confirm mdx Tissue Post biopsy Select mdx Urine Pre biopsy AS or Oncotype DX Tissue treatment intensity Monitor mdx TBD AS Monitoring © 2022 mdx