Molecular Diagnos/c Solu/ons for Urologic Cancer

Transcription

1 Molecular Diagnos/c Solu/ons for Urologic Cancer 2016 Company Presentation Dr. Jan Groen, President & CEO

2 Forward Looking Statement 2 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. Analyst Coverage 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.

3 3 OUR MISSION To improve pa/ent outcomes by delivering molecular diagnos/c solu/ons for urologic cancers.

4 Company Highlights MDxHealth 4 Market leader Improving diagnosis Listed on Euronext Offices in molecular diagnostics with a focus on urology sales: $12M FY sales est.$18m of urological cancers with expanding suite of products - ConfirmMDx for Prostate - SelectMDx for Prostate publically traded multinational healthcare company - Euronext - (Ticker: MDXH.BR) Headquarters in Irvine, CA - Herstal, Belgium - Nijmegen, The Netherlands - 35,000 patients tested - AssureMDx for Bladder

5 5 Global Incidence of North America & Europe Annual Numbers Prostate and Bladder Cancer Annual Numbers 420, ,134 New cases of prostate cancer 288, , , , , ,211 New cases of bladder cancer 84,062 62,380 53,366 17,705 20,716 4,085 27,519 27, 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

6 MDxHealth Business and Product Strategy US & EU 6 Instrumentation Technology & Products Commercial Biomarkers (CE & LDT) Channel Microtome Pathology Prostate Direct sales force PCR Epigenetic (DNA) Bladder Partnerships NGS Genetic (RNA) Kidney Distributors

7 7 Product Offering

8 Prostate Cancer Challenges Annual Numbers 8 Projected growth prostate drug market $8.7 billion $5.7 billion $4 billion $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 Source: Prostate Cancer Market Snapshot: More Then Provenge, The Pink Sheet, Nov 22, Elsevier Business Intelligence Publica/ons and Products

9 Early Detection is Important Significant Prostate Cancer 9 1 in 6 Men will develop prostate cancer in their lifetime 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 Shen et al: J. Ultrasound Med. 2008; Jun; 27(6):

10 Prostate Cancer in the United Sates Annual Numbers million Abnormal PSA tests 1 Who needs an initial biopsy? 1.3 million Biopsy procedures 2 Who needs a repeat biopsy? Biomarkers 241,000 Diagnosed with PCa 3 Who needs intervention? needed 27,540 Deaths Aubry W et al:. American Health Drug and Benefits (1): 15-24

11 11 Who Needs a Biopsy?

12 SelectMDx for Prostate Cancer Unmet Clinical Need million Improve patient selection for the men will undergo biopsy decision to biopsy

13 Need to Improve Patient Selection for Prostate Biopsy 13 Out of 1.3 Million Men Who Undergo Prostate Biopsy Each Year 25% will receive a false-negative result Image from AACR Founda/on 15% will suffer complications from biopsy (e.g. bleeding, infections, etc.) ~3% will be hospitalized in 30 days following biopsy Transrectal Ultrasound Guided 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): , 3. Loeb S, Carter HB, Berndt SI, et al:, J Urol. 2011;186:

14 14 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

15 SelectMDx for Prostate Cancer Provides actionable results for the decision to biopsy 15 Likelihood of high grade prostate cancer Biopsy? Elevated Serum PSA No Biopsy Likelihood of low grade prostate cancer

16 SelectMDx Performance SelectMDx for Prostate Cancer 16 ROC Curve for Clinically Significant Cancer Correlation with Gleason Score Sensi/vity SelectMDx Risk Profile p<0.001 p< Specificity No PCa GS 6 GS 7

17 Patient Report Sample 17 Risk Profile: Low Risk Men who may avoid biopsy Decreased risk for aggressive cancer High Risk Men who may benefit from biopsy Increased risk for aggressive cancer Identification of a Candidate Gene Panel for the Early Diagnosis of Prostate Cancer. Leyten et al. Clin Cancer Res, 2015

18 Competition Who to Biopsy 18 Assay Characteris4cs Company Beckman Coulter Opko MDxHealth Specimen Blood Blood Urine Assay Characteris/cs Immuno assay Immuno assay qpcr Assay 3 Protein biomarkers 4 kallikriens biomarkers 3 mrna Biomarkers tpsa and fpsa, propsa PSA, fpsa, Intact PSA, HK-2 DLX1, HOXC6 Regulatory FDA/CE LDT/ CLIA/CE LDT/CLIA/CE List price ($) $499 $1,200 $500 Assay Performance (AUC) AUC 0.73 AUC 0.82 AUC 0.90 Comments Requires Phlebotomist Requires Phlebotomist No Phlebotomist Required Curr Opin Oncol May ; 26(3):

19 False Negative Biopsy Challenge

20 Need to Improve Patient Selection for Repeat Biopsy 20 Unmet Clinical Need ~1.3 million ~241k ~1 million Prostate biopsy procedures Diagnosed with PCa With negative biopsy ~25% with a false negative biopsy Aubry W et al:. American Health Drug and Benefits (1): 15-24

21 False Negative Biopsy Challenge ~25% of Men With Undetected Prostate Cancer million biopsy procedures per year Needle may miss cancer Pathologists can only interpret what is on the slide A biopsy procedure samples <1% of the gland Follow up is a repeat biopsy Image from AACR Founda/on Transrectal Ultrasound Guided 12 Core Biopsy

22 Fear of Undetected Cancer Leads to High Rate of Repeat Biopsy 22 Elevated Clinical Risk Factors Elevated PSA, Abnormal DRE, Family History TRUS Guided Prostate Biopsy Standard 12-core biopsy Unnecessary Repeat Biopsy Patient Compliance, Infections, Negative Prostate Biopsy Sampling error, Needle Missed Mark 43% of men undergo repeat biopsy Welch HG et al:. J Natl Cancer Inst 2007;99: Pinsky PF et al:. BJU International 99, no. 4 (April 2007):

23 Lead Product 23 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

24 The Most Significant Independent Predictor for Prostate Cancer Detection on Repeat Biopsy 24 ConfirmMDx for Prostate Cancer Odds Ratio for GS 7 PCa 15.8 Area Under the Curve Age % + Biopsies PSA Atypia ConfirmMDx Risk Score Clinical Risk Factors PSA PTPTRC2 ConfirmMDx Risk Calculators 1) Van Criekinge et al; NOMCC: ; 2015 AUA Prostate Cancer: Detection and Screening V. 2) Partin AW et al; J Urol ) Stewart GD et al; J Urol 2013

25 Likelihood of Prostate Cancer on Repeat Biopsy 25 ConfirmMDx for Prostate Cancer 96% NPV for aggressive prostate cancer

26 Patient Report 26 Risk Profile: Sample Low Risk Men who may avoid biopsy Low likelihood of harboring aggressive cancer High Risk Men who benefit from biopsy High likelihood of harboring aggressive cancer

27 Competition Who to re-biopsy 27 Characteris4cs Company Hologic MDxHealth Specimen Urine Tissue Assay Characteris/cs' qpcr Methyla/on PCR mrna test, 1 biomarker DNA test, 3 biomarkers PCA3 GSTPi, RASFF1, APC Regulatory FDA/CE LDT/ CLIA List price ($) $500 $3,300 Reimbursement Medicare Medicare Assay Performance (NPV) NPV 90% NPV 96% for CS PCa Comments Indicates risk for cancer (any grade) Indicates loca/on & aggressiveness Curr Opin Oncol May ; 26(3):

28 28 Who requires cystoscopy?

29 Bladder Cancer in the US Unmet Clinical Need 29 1 million Hematuria pa/ents per year Methods for detection of bladder cancer are often inadequate, leaving many patients at risk for delayed diagnosis 72,000 Newly diagnosed bladder cancer cases

30 Need to Improve Bladder Cancer Diagnosis Diagnostic Modalities 30 Over 700,000 invasive cystoscopies procedures per year Cystoscopy Cytology Bladder wash or urine Histology of tissue biopsy

31 A Non-Invasive Approach to Stratify Patient Risk 31 Improving Patient Selection for Cystoscopy DNA Methylation Assay Provides physicians with actionable information to: Rule out: bladder cancer in patients with hematuria Reduce: invasive cystoscopy procedures Identify: patients at high-risk for bladder cancer Three Epigenetic Biomarkers TWIST ONECUT2 OTX1 LDT Under CLIA

32 Technical Validation AssureMDx for Bladder Cancer Performance 32 97% 76% 78% 82% 99% Negative Predictive Value 97% Sensitivity 44% 83% Specificity Cytology Fish NMP CxBladder ConfirmMDx AssureMDx BCa Comparison Sensitivity Van Kessel et al., JURO. Vol. 195, 1-7, 2016

33 33 99% NPV Confirming the absence of bladder cancer

34 Competitors Bladder Cancer Confirmation 34 Assay Characteris4cs Company Abbok Matritech Pacific Edge MDxHealth Specimen Urine Urine Urine Urine Assay Characteris/cs DNA hybridiza/on (FISH) Immuno assay qpcr Assay Methyla/on PCR 4 DNA Biomarkers 1 Protein biomarker 5 mrna Biomarkers 3 DNA Biomarkers aneuploidy of NMP22 IGFBP5, HOXA13, MDK TWIST, ONECUT2 and chromosomes 3, 7, 17, and CDK1 OTX1 & loss of both 9p21 loci Regulatory FDA/CE FDA/CE LDT/ CLIA/CE LDT/CLIA List price ($) ~$600 ~$25 ~$2,900 $500 Sensi/vity (%) Sens 76% Sens 78% Sens 82% Sens 97%

35 Prostate and Bladder Cancer Market U.S. 35 $2,750 $1,700 Revenue Millions $500 $250 $300 SelectMDx for Prostate Cancer ConfirmMDx for Prostate Cancer ConfirmMDx for Bladder Cancer RecurMDx for Bladder Cancer Total Available Market

36 Global Commercialization Experienced Commercial Team 36 ISO Lab CLIA MDxHealth Direct & Distributors Distributors Contract discussions with distributors

37 Commercialization US and EU 37 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

38 Proven Sales Team Molecular Diagnostic Specialists MDxHealth Managed Care - 3 MDxHealth Sales Force - 37 MDxHealth Client Services - 6 Sales reps with a proven track record Diverse clientele of small and large group practices Sales Team: 83 Focused guideline strategy Strategically utilizing co-marketing partnership labs Partnerships Sales Force - 37

39 Annual Sales Volume MDxHealth Lead Product 39 >15,000 12,300 7,000 Product launched in June 2012 >35,000 patients tested 1,100 Guidance P

40 40 US Male Population Age % of at-risk population covered 43,605,000 Medicare Coverage: Nov. 3rd, 2014 Medicare Male Popula/on: 24,717,805 Expanding Commercial Insurance Coverage Extensive PPO/TPA Network Contracts United States Census Bureau 2014 National Projections Kaiser Family Foundation, 2012 Palmetto GBA LCD #L35368 MDxHealth Internal Data

41 ConfirmMDx Payor Mix (US) Selected Payers Reimbursing for Testing 41 1% 1% 32% 33% Commercial Medicare Medicaid Medicare Advantage 33% Tricare

42 Continued Revenue Growth MDxHealth 42 $16 $ Millions $11.7 $7.6 $5.2 $3.6 Guidance 2011Y 2012Y 2013Y 2014Y 2015P P = Results pending

43 2015 Performance Financials 43 Revenue for the first 9 months up 44% ($12M) ConfirmMDx Q4 sales volume rose 50% over Q Net loss decreased by 16% in the first nine months of 2015 $35M in cash and cash equivalents Subsequently, acquired NovioGendix for $8.8M, inclusive of MDxHealth shares and milestones

44 MDxHealth News Flow 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

45 45 Appendix

46 The Foundation of Exact Science s Cologuard 46 Non-invasive Colon Cancer Screening Test Technology licensed to Exact Sciences Exact Sciences test uses methods, based on MDxHealth s technology Exclusive use of MDxHealth biomarker for stool-based detection Non-exclusive access to MDxHealth s MSP platform Licensing Terms Up to $3M in milestones and maintenance fees Royalties in the mid-single digit range The license agreement runs through 2028 FDA Approved / Medicare Covered

47 PredictMDx for Glioblastoma 47 MGMT Biomarker Test Technology licensed to LabCorp LabCorp test uses methods based on MDxHealth s technology and biomarker Exclusive North America rights to use MDxHealth biomarker in brain tissue Royalties in the double digit range Clinical Use Included in the NCCN guidelines Tier 1 reimbursement code LDT, tissue based test for Test required in newly diagnosed stage IV Glioma Brain Cancer