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20160126 smb m dx health jan groen

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Presentation SMB Meeting January 26. 2016 on Novio Tech Campus

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20160126 smb m dx health jan groen

  1. 1. Molecular Diagnostic Solutions for Urologic Cancer 2016 Company Presentation Dr. Jan Groen, President & CEO ©2016 All rights reserved
  2. 2. ©2016 All rights reserved Forward Looking Statement 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 various assumptions & 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'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 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. Any opinions, estimates or forecasts made by analysts are theirs alone and do not represent opinions, forecasts or predictions of MDxHealth or its management. Requests for copies of analyst reports should be directed at the respective analyst & institution. Analyst Coverage 2
  3. 3. ©2016 All rights reserved OUR MISSION To improve patient outcomes by delivering molecular diagnostic solutions for urologic cancers. 3
  4. 4. ©2016 All rights reserved 4 : “MDxHealth has maintained its commitment to advancing molecular diagnostic tests for urological cancers, continuing to generate data supporting its ConfirmMDx® for Prostate Cancer test, and furthermore, recently launched its urine-based “liquid-biopsy” test, SelectMDx™ for Prostate Cancer. Frost & Sullivan believes that these two offerings can significantly reduce the number of men undergoing unnecessary invasive biopsy procedures, and importantly helps avoid the associated pain, risk of complications, and cost.” Frost & Sullivan Senior Industry Analyst, Divyaa Ravishankar, commented:
  5. 5. ©2016 All rights reserved Company Highlights MDxHealth Listed on Euronext publically traded multinational healthcare company - Euronext - (Ticker: MDXH.BR) Offices Headquarters in Irvine, CA - Herstal, Belgium - Nijmegen, The Netherlands Improving diagnosis of urological cancers with expanding suite of products - ConfirmMDx for Prostate - SelectMDx for Prostate - AssureMDx for Bladder Market leader in molecular diagnostics with a focus on urology - 2015 FY sales est.$18M - 35,000 patients tested 5
  6. 6. ©2016 All rights reserved Global Incidence of Prostate and Bladder Cancer 218,182 164,180 420,899 158,211 288,235 84,062 167,357 27,272 53,36662,380 27,519 4,08520,71617,705 North America & Europe Annual Numbers 709,134 New cases of prostate cancer 242,273 New cases of bladder cancer Annual Numbers 1. GLOBOCAN 2012 (IARC) Population forecasts were extracted from the United Nations, World Population prospects, the 2012 revision. Numbers are computed using age-specific rates and corresponding populations for 10 age-groups. India Australia New Zealand China Latin America Asia North America Europe ©2016 All rights reserved 6
  7. 7. ©2016 All rights reserved Products and Timelines MDxHealth R&D Validation Clinical Utility Launch MDxHealth Partnered US US & EU US & EU US US USMGMT** * * ** 7
  8. 8. ©2016 All rights reserved MDxHealth Business and Product Strategy US & EU • Microtome • PCR • NGS • Biomarkers • Epigenetic (DNA) • Genetic (RNA) • Prostate • Bladder • Kidney • Direct sales force • Partnerships • Distributors Instrumentation Technology & Biomarkers Products (CE & LDT) Commercial Channel 8
  9. 9. ©2016 All rights reserved Product Offering ©2016 All rights reserved 9
  10. 10. ©2016 All rights reserved Prostate Cancer Challenges Annual Numbers $10 billion 27,540$4 billion spent on the diagnosis and screening of prostate cancer spent on the treatment of prostate cancer men die annually from prostate cancer Projected growth prostate drug market $4 billion $5.7 billion $8.7 billion 2009 2014 2019 Source: Prostate Cancer Market Snapshot: More Then Provenge, The Pink Sheet, Nov 22, 2010. Elsevier Business Intelligence Publications and Products 10
  11. 11. ©2016 All rights reserved Early Detection is Important Significant Prostate Cancer Men will develop prostate cancer in their lifetime 1 in 6 1 in 4 Men will be diagnosed with a false-negative biopsy 1. Taneja et al: AUA Optimal Techniques of Prostate Biopsy and Specimen Handling 2013. 2. Shen et al: J. Ultrasound Med. 2008; Jun; 27(6): 895-905 11
  12. 12. ©2016 All rights reserved Prostate Cancer in the United Sates Abnormal PSA tests Biopsy procedures Diagnosed with PCa Deaths 4.7 million 1.3 million 241,000 27,540 Who needs an initial biopsy? 1 Who needs a repeat biopsy? 2 Who needs intervention? 3 Biomarkers needed Annual Numbers Aubry W et al:. American Health Drug and Benefits 2013.6(1): 15-24 12
  13. 13. ©2016 All rights reserved Who Needs a Biopsy? 13
  14. 14. ©2016 All rights reserved Improve Patient Selection for Initial Prostate Biopsy Non-invasive Liquid Biopsy Assay  RT qPCR method  Urine-based test  3 mRNA genes (HOXC3, DLX1, KLK3)  LDT under CLIA  CE marked IVD kit ©2016 All rights reserved 14
  15. 15. ©2016 All rights reserved False Negative Biopsy Challenge
  16. 16. ©2016 All rights reserved Unmet Clinical Need Prostate biopsy procedures ~1.3 million Diagnosed with PCa ~241k With negative biopsy ~1 million ~25% with a false negative biopsy Aubry W et al:. American Health Drug and Benefits 2013.6(1): 15-24 Need to Improve Patient Selection for Repeat Biopsy 16
  17. 17. ©2016 All rights reserved Lead Product ConfirmMDx for Prostate Cancer An LDT to Aid on the Decision for Repeat Biopsy • RT MSP DNA Methylation assay • Three epigenetic biomarkers (GSTPi, RASSF1 and APC) • LDT under CLIA • Uses residual tissue biopsy sample Tissue Biopsy ©2016 All rights reserved 17
  18. 18. ©2016 All rights reserved CLIA Global Commercialization Experienced Commercial Team MDxHealth Direct & Distributors Distributors ISO Lab Contract discussions with distributors 18
  19. 19. ©2016 All rights reserved Commercialization US and EU • Laboratory developed test • Large national sales force • Established client base • Reimbursement experience • Strong KOL support • CE marked in-vitro diagnostic kits • Direct sales • Distributors • Reimbursement: gov, private ins, patient • Launched in Benelux 19
  20. 20. ©2016 All rights reserved MDxhealth Proven Commercial Team Molecular Diagnostic Specialists Sales Team: 87 Managed Care - 3 Client Services - 6US Sales Force - 37 Partnerships Sales Force - 37 Sales reps with a proven track record Unparalleled client serivces Focused guideline strategy Strategically utilizing co-marketing partnership labs EU Sales Force - 4 Growing international sales force
  21. 21. ©2016 All rights reserved Growing Number of Ordering Physicians 2012 2013 2014 2015 2,500+200+ 1000+ ~2000 Cumulative Ordering Urologists Since Launch 21 10,000 Urologist in the US 8,500 Office based urologists
  22. 22. ©2016 All rights reserved 2012 2013 2014 2015P >15,000 12,300 7,000 1,100 Guidance Annual Sales Volume MDxHealth Lead Product • Product launched in June 2012 • >35,000 patients tested 22
  23. 23. ©2016 All rights reserved MDxHealth News Flow 2016  Publication of SelectMDx validation study  Launch SelectMDx on US market in H1  Expansion contracts US payors  Publication of bladder cancer validation study  Launch AssureMDx in Q4 23