Epigene'c Diagnos'cs for Oncology

Transcription

1 Epigene'c Diagnos'cs for Oncology Dr. Jan Groen President & CEO Corporate Presenta1on 2015

2 Forward Looking Statement This presenta1on contains forward- looking statements & es1mates made by the management of the Company with respect to the an1cipated future performance of MDxHealth & the market in which it operates. Such statements & es1mates are based on various assump1ons & assessments of known & unknown risks, uncertain1es & 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 condi1on, 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 & es1mates. Given these uncertain1es, no representa1ons are made as to the accuracy or fairness of such forward- looking statements & es1mates. MDxHealth disclaims any obliga1on to update any such forward- looking statement or es1mates to reflect any change in the Company s expecta1ons with regard thereto, or any change in events, condi1ons or circumstances on which any such statement or es1mate is based, except to the extent required by Belgian law. Analyst Coverage Any opinions, es1mates or forecasts made by analysts are theirs alone and do not represent opinions, forecasts or predic1ons of MDxHealth or its management. Requests for copies of analyst reports should be directed at the respec1ve analyst & ins1tu1on.

3 Global Leader in Epigene3c Diagnos3cs 3 Commercial Products Proprietary Epigene1c Pla\orm Over 20,000 ConfirmMDx Tests Reported High Value Reimbursement

4 Q Performance Total revenue increased 114% USA ConfirmMDx revenue increased 177% to $4.0 M Completed enrollment PASCUAL Medicare trial $2.8 M net loss in Q Cash and cash equivalents of $14 M

5 Our Business Model Diagnosis Shipping Processes Reports Biopsy Sampling Accredited Results Urology Pathology Lab Physician Confiden1al Informa1on 2015 MDxHealth Inc. All rights reserved.

6 U.S. Prostate and Bladder Cancer Market $ Millions $ 300 >$ 2,000 $ 1,700 $ 250 ConfirmMDx for Prostate ConfirmMDx for Bladder RecurMDx for Bladder Total Market Opportunity

7 The False Nega3ve Prostate Biopsy Challenge 1 in 4 men are misdiagnosed Fear of undetected prostate cancer leads to a high rate of repeat biopsies.

8 Prostate Cancer in the USA The Need For Beger Diagnos1cs... 1 out of 6 Men Diagnosed with Prostate Cancer ~1.3 Million Biopsies Per year $4.4 Billion Spent on Screening & Diagnosing $ $9.9 Billion Spent on Treatment ConfirmMDx provides ac3onable informa3on to address clinical need

9 Prostate Cancer in the USA ~1,300,000 Prostate biopsy procedures ~1,000,000 With a nega3ve biopsy procedure ~233,000 Diagnosed with prostate cancer ~29,000 Deaths from prostate cancer 25% false nega've biopsy rate

10 The False- nega3ve Biopsy Challenge Standard Of Care seminal vesicle cancer left biopsy prostate posterior view base apex seminal vesicle right Challenges <1% of Prostate Sampled Needle May Miss Cancer Pathologist can only interpret what is seen on the slide Follow Up is a Repeat Biopsy

11 The Procedure Prostate Cancer seminal vesicle prostate posterior view base seminal vesicle ConfirmMDx FFPE Sample Biopsy left right Field Effect Prostate Mapping apex Avoid Repeat Biopsy

12 The Epigene3c Solu3on RULE OUT prostate- cancer- free men from undergoing unnecessary repeat biopsies RULE IN those who may require a repeat biopsies Provides ConfirmMDx mapping results to guide repeat biopsy

13 The Sample Transporta3on Kit Confiden1al Informa1on 2015 MDxHealth Inc. All rights reserved.

14 Sales and Marke3ng Stakeholders Pa3ents 650,000 US Unnecessary Market Repeat Up Biopsy $1b Urologists Payors

15 Valida1on Studies Development & Valida3on Mul1plex 4- gene MSP test 45+ studies, > 5,000 pa1ents Op1mized for 1ssue amount Clinical Valida3on & U3lity NPV of 90% in blinded studies 10 fold reduc1on in repeat biopsy independent predictor of PCa cancer

16 Health Economics $588 Savings

17 ConfirmMDx Payer Mix 1% Tricare 1% Medicaid Selected Payers 33% Commercial 32% Medicare 33% Medicare Advantage

18 Sales CA OR WA NV ID UT AZ MT WY NM CO ND SD NE TX KS OK MN IA MO AR LA WI IL ME VT NH MA NY CT MI RI PA NJ DE OH IN DC MD WV VA KY NC MDxHealth (20) Metamark (14) Miraca (21) Bostwick (40) MS TN AL GA SC FL Overview Co- marke1ng Agreements Direct Na1onal Sales Force Establishing ROW Distribu1on Network

19 Quarterly Cumula1ve Sales Units Units 14,000 12, , Q1 Q2 Q3 Q4

20 Product Pipeline Product Development Stage R&D Valida1on U1lity Launch Prostate Risk Score Bladder ConfirmMDx Bladder RecurMDx

21 I have hematuria Does this mean I have cancer? Who is at risk for bladder cancer? How can you be sure?

22 Hematuria & Bladder Cancer in the USA 15,000 Deaths USA 72,500 Diagnosed with Bladder Cancer >700,000 Cystoscopy Procedures ~ 1M Referred to Urology 7M Haematuria Pa1ents Per Year

23 Bladder Cancer Liquid Biopsy Epigene1c Test Performance Nega1ve Predic1ve Value of 95% Posi1ve Predic1ve value of 86% Sensi1vity of 94% Specificity of 91%

24 Financials Q News Flow

25 Cumula1ve Quarterly Revenue Dollars in Millions Q1 Q2 Q3 Q4

26 License Partners Licensing Colon Cancer Brain Cancer Cervical Cancer

27 Key Financials Q Cash & Cash Equivalents of ~$14M Monthly Cash Burn of $1.4M Euronext (Ticker: MDXH.BR) No Debt Number of Shares ~37.7M Revenue Grew 114 % Market Cap Today: ~$200M

28 Share Characteris1cs Free float- 62.5% Petercam- 4.0% Valiance- 17.2% Biovest- 16.3%

29 News Flow 2015 Epigene1c Health Index for ConfirmMDx Clinical Guidelines Update Complete enrollment PASCUAL Publica1on Bladder Cancer Valida1on study Expanding contracts with US payers