Mdxhealth Sa · NASDAQ:MDXH
Mdxhealth Sa — Investor Presentation (August 2021)
26 slides from Mdxhealth Sa's investor presentation, August 2021
Slide 1: Corporate Presentation
CORPORATE PRESENTATION August 2021 © 2021 MDxHealth. All rights reserved
Slide 2: Forward Looking Statement
Forward Looking Statement This presentation contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncert
Slide 3: MDxHealth mission statement
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.BR © 2021. All rights reserved Corporate Presentation I 3
Slide 4: Providing Urologic and Healthcare Economic Solutions Across the Clinical Care Continuum
Providing Urologic and Healthcare Economic Solutions to Patients, Clinicians, and Payers Across the Clinical Care Continuum Growth Driven by Commercial Urologic Menu Expansion Industry Leadership Execution Active Surveillance for Prostate Cancer Driving focus and execution with direct Driving adopti
Slide 5: Strategy and Focus
Strategy and Focus Operating Discipline Commercial Pathway Acceleration Innovative Pipeline • Efficient and scalable laboratory operations • Broad urologic menu of non-invasive tests • Extensive proprietary IP portfolio of • Rigorous focus on revenue cycle • Clinical guideline inclusion driving path
Slide 6: Experienced Leadership Team
Experienced Leadership Team Track record of success Miriam Reyes Joseph Sollee Michael K. McGarrity Ron Kalfus John Bellano Executive Vice President Executive Vice President Chief Executive Officer Chief Financial Officer Chief Commercial Officer Laboratory Operations Corp. Dev. & General Counsel Jo
Slide 7: Menu and Pipeline: Prostate Cancer Precision Diagnostics
Menu and Pipeline: Prostate Cancer Precision Diagnostics 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
Slide 8: Current Challenges with Diagnosing Prostate Cancer in the U.S.
Current Challenges with Diagnosing Prostate Cancer in the U.S. Prostate Cancer Screening Prostate Cancer Diagnosis 3 million elevated PSA results annually(1-2) 500,000 men undergo biopsies annually 30% of cancer-negative biopsies 60% of biopsies DO NOT reveal are false negatives, meaning 60% cancer
Slide 9: Annual U.S. Market Opportunity
Annual U.S. Market Opportunity Current Market Opportunity: $2B Who needs a biopsy? Who needs a repeat biopsy? 3M Eligible for: 300K Eligible for: 250K Cancer-negative New prostate Elevated PSA biopsies cancer annually cases $1.5B Market $500M Market Out of 25M PSAs Out of 500K prostate biopsies Acti
Slide 10: 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 Cancer Biopsy / Biopsy / Positive Positive Imaging Imaging Routine No Cancer Screening Detected
Slide 11: Improves Patient Selection Prior to Prostate Biopsy
Improves Patient Selection Prior to Prostate Biopsy A highly predictive test to identify men at low risk for aggressive prostate cancer At risk for aggressive cancer? Positive Biopsy Routinely Negative Monitor Abnormal PSA/DRE 95% NPV Binary Actionable Results for patient and HCP • Non-invasive urin
Slide 12: Robust Clinical Evidence
Robust Clinical Evidence 12 published studies on genes and technology (> 3,500 patients) Analytical Validity Clinical Validity Clinical Utility Health Economics Pivotal Clinical Studies Hessels et al., Analytical Validation Translational Medicine Communications 2017 Haese et al., Clinically Validate
Slide 13: Improves Diagnostic Confidence of Biopsy Result
Improves Diagnostic Confidence of Biopsy Result The only epigenetic test to identify men at risk for aggressive prostate cancer 12-core needle biopsy could miss the mark Biopsy Core Positive Cancer Re-biopsy Field Effect Positive / MRI Cancer Prostate Negative Avoid re- Biopsy Core Urethra Prostate
Slide 14: Robust Clinical Evidence
Robust Clinical Evidence Over 55 published studies on genes and technology (> 5,500 patients) Analytical Validity Clinical Validity Clinical Utility Health Economics Pivotal Clinical Studies Van Neste et al., Analytical Validation BMC Urology 2013 Partin et al., Validation of High NPV Journal of Uro
Slide 15: 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 / Imaging Biopsy Negative (if positive) Biopsy decision Active Surveillance
Slide 16: AS-MDx Stratifies Patients for Active Surveillance versus Intervention
AS-MDx Stratifies Patients for Active Surveillance versus Intervention Positive Intervention 134K AS-MDx Est. Market size Active (Men Annually) Negative Low-grade Surveillance prostate cancer • Not all men diagnosed with localized prostate cancer benefit from intervention; some tumors are slow-growi
Slide 17: Monitor-MDx to Validate Continued Active Surveillance
Monitor-MDx to Validate Continued Active Surveillance High Risk Intervention 1.5M Monitor- Est. Market size MDx Continued Active (Men Annually) Under Active Low Risk Surveillance Surveillance (Low-grade cancer) • Patients under active surveillance are currently monitored by invasive and costly prost
Slide 18: U.S. Urinary Tract Infection (UTI) Annual Market Opportunity
U.S. Urinary Tract Infection (UTI) Annual Market Opportunity UTIs are the most common outpatient infection in the U.S.(1) • 10 million suspected UTI cases present annually(2) U.S. Market for UTI* • An estimated 20% of volume presents to Urology* The current UTI testing market is underserved Long Ter
Slide 19: U.S. Total Addressable Market Opportunity: $4.6B
U.S. Total Addressable Market Opportunity: $4.6B $5B $1B $4.6B $4B $1.5B $3B $134M $500M $2B $1.5B $1B AS-MDx Monitor-MDx UTI Total TAM Unmet clinical need (Based on management estimates) © 2021 MDxHealth. All rights reserved Corporate Presentation I 19
Slide 20: Prostate Cancer Biomarkers
Prostate Cancer Biomarkers Category Company Test Specimen Genes MDxHealth Urine DLX1, HOXC6, KLK3 Pre-biopsy OPKO Blood Total PSA, free PSA, Intact PSA, hK2 ExosomeDx Urine PCA3, ERG, SPDEF Beckman Coulter Blood PSA, free PSA, pro2PSA (index) MDxHealth Tissue GSTP1, APC, RASSF1 Post-biopsy Hologic U
Slide 21: Fundamentals in Place to Drive Sustained Growth
Fundamentals in Place to Drive Sustained Growth Strong Commercial Focus Proven Reimbursement Robust and Reliable and Presence Strategy Technology Leveraging direct sales force in U.S. ConfirmMDx covered by Medicare Proprietary IP portfolio capable of and commercial payers advancing our diagnostic pa
Slide 22: Guideline Inclusion and Payer Coverage
Guideline Inclusion and Payer Coverage 160 140 Draft Coverage NCCN SelectMDx Guidelines SelectMDx 120 ConfirmMDx & 2016 NCCN Guidelines inclusion SelectMDx Payer Contracts 2014 Medicare coverage 100 NCCN Guidelines ConfirmMDx 80 Launch 60 40 ConfirmMDx 2020 NCCN Guidelines inclusion Launch 20 2021 M
Slide 23: Statements of Profit or Loss
Statements of Profit or Loss USD in 6 Months 6 Months Thousands Ended June Ended June % Change (unaudited) 30, 2021 30, 2020 Revenue SelectMDx Test Volume 7,051 6,485 9% • Approximately 97% attributable to services and 3% to licenses and royalties ConfirmMDx Test Volume 7,978 7,662 4% • ConfirmMDx r
Slide 24: We Believe MDxHealth is De-risked for Sustainable Growth & Value Creation
We Believe MDxHealth is De-risked for Sustainable Growth & Value Creation Commercial execution: Experienced leadership and process-based focus to support growth 01 Operating discipline: Instituted through new leadership and all drivers of the P&L 02 Menu expansion: Clearly defined and initiated to c
Slide 25: Thank You
Thank You Global Operations Investor Relations Contact LifeSci Advisors, LLC US +1 949 271 9223 [email protected] U.S. Headquarters & Laboratory Global Headquarters R&D & Laboratory 15279 Alton Parkway, Ste 100 CAP Business Center Novio Tech Campus Transistorweg 5 Irvine, CA 92618 Rue d’Abhooz, 31 65
Slide 26: Presentation References
Presentation References SUMMARY REFERENCE CITATIONS 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 pro