Molecular Diagnostic Solutions for Urologic Cancer

Transcription

1 2018 All rights reserved 1 Molecular Diagnostic Solutions for Urologic Cancer 2017 Full Year Financial Results February 22, 2018

2 2 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 forwardlooking 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 Overview Financial Performance 35% Increase in total revenue $28.2M Product & service revenue $40.5M Total revenue Business Execution > 33,100 Patients tested 14% Increase for ConfirmMDx in Q4 >300% SelectMDx increase in Europe test volume TWO Integrated health system contracts MDxHealth Transformation New research & service Lab in the EU Expanded and reorganized sales force

4 4 Highlights 20 new US payor contracts (62 contracted payors) Increased sales force from 33 to 50 Global test volume up from 20,400 in 2016 to 21,400 in 2017 Q4 total test volume up 14% to 6,400 in 2017 Action taken in Q4 to reorganize sales team structure Greater focus on key accounts in new US payor contracts (now totalling 15 payors) 9 distribution agreements signed in 2017 (7 countries across EU now covered) Global launch of the IVD PCR Kit $ adoption by first large medical lab 2017 total global test volume of 11,700 vs. 4,000 in % increase in EU test 3,100 patients tested in EU in2017

5 5 Growth Strategy - 4 Key Pillars Drive adoption & Increase the clinical Expand usability and Work with acceptance of utility of SelectMDx access to tests by pharmaceutical commercial tests to encompass both porting onto IVD partners to create with urologists, active and recurrence sample-to-answer precision diagnostics primary care monitoring of platforms physicians and patients payors in US and EU Two Critical Global Trends The ever-growing incidence of cancer globally Demand for fast, actionable, cost-effective diagnosis and patient monitoring Addressing market of $4.2 billion and growing by 7% to $4.6 billion in 2022

6 6 Financials Jean-Marc Roelandt EVP & CFO 2017 Full year financial release February 22, 3pm 2018

7 2016 All rights reserved 7 FY 2017 Financial Highlights 33k Patients tested $40.5M Total revenue $12.3M Operating loss -$10.4M EBITDA Cash Collection Increase Growth compared to FY % 35% 2016: $12.8M 2016: $-11.1M 17%

8 8 Continued Strong Volume Growth Total volumes up 39% in 2017 SelectMDx test volume up more than 300% since global launch Stronger Q4 performance reflects sales team growth

9 9 Continued Revenue Growth Total Revenue up 35% $40.5 Includes $12.1M (payment by $30.0 Exact Sciences for MDxHealth $17.6 patents) ConfirmMDx represents 91% of total revenue 2H revenue impacted by shortfall in projected billable ConfirmMDx cases from large multi-center study

10 10 Payer Contract & Commercial Policy Summary 2017 YTD Accomplishments 25 ConfirmMDx contracts YTD (67 total) 7 positive ConfirmMDx medical policies YTD (35 total) 4 SelectMDx commercial contracts YTD (15 total) $1,545,969 in MAP Recoupment

11 11 Additional Key Figures for FY 2017 Key unaudited consolidated figures for the year ended December 31 (thousands of US dollars, except per share data) Change Change as a % Revenue 40,508 29,970 10, % Gross profit 30,305 19,867 10, % Operating expenses (42,579) (32,713) (9,866) (30.2)% EBITDA (profit/(loss)) (10,388) (11,124) % Operating profit/(loss) (EBIT) (12,274) (12,846) % Net income/(loss) (12,288) (13,174) % Earnings per share, basic ($) (0.25) (0.26) %

12 12 Balance sheet and Cash flow statement Cash flow statement ('000$) Operating cash flow (10.494) (16.585) Investing cash flow (4.948) (5.316) Financing cash flow (532) Cash +/(-) (15.974) (806) Opening cash FX impact (3) Ending cash Balance sheet ('000$) Non-current assets Current assets TOTAL ASSETS Shareholders' equity Non current liabilities Current liabilities TOTAL EQUITY AND LIAB Cash at December 31, 2017 of $16.8 million Cash collections from ConfirmMDx and SelectMDx amounted to $23.1 million, 17% more than a year earlier Working capital requirement expected to reduce since ConfirmMDx CPT code is effective (January 2018)

13 13 Jan Groen CEO 2017 Full year financial release February 22, 3pm 2018

14 Roadmap to Product Launch and Reimbursement years Lifecycle Stage Analytical Validation Clinical Validation Clinical Utility Budget Impact Study Clinical Guidelines Payor Contracts High Real world clinical utility Clinical Adoption Comparative effectiveness Investigational use Test commercially available Low Early Adapted from Personalized Medicine (2012) 9(1), Payor involvement (PPO) Test Maturity (level of Evidence) Established

15 Commercial strategy CLIA Lab US Service Lab EU Laboratory developed test (LDT) Large national sales force 50 reps Reimbursement Medicare & commercial CE-marked in-vitro diagnostic (IVD) kits Direct sales 5 reps Distributors 15

16 Research Collaborations Support Our Pipeline: Develop and validate blood based test for CRPC Validate licensed MISH visualization technology for bladder and prostate cancer products Discovery and development of near future kidney cancer (epi)genetic-based assays 16

17 17 Growth Strategy and Upcoming Newsflow Drive adoption and Increase the clinical Expand usability and Work with acceptance of utility of SelectMDx to access to tests by porting pharmaceutical partners commercial tests with encompass both primary onto IVD sample-to- to create precision urologists and payors in care and the active and answer platforms diagnostics US and Europe recurrence monitoring of patients Formal application for Medicare coverage through Local Coverage Determination (LCD) for SelectMDx expected in 2018 Clinical utility studies and budget impact studies to drive efforts to secure further payor contracts for SelectMDx Results of the prospective 4M study expected in 2018 Significant market expansion for SelectMDx into active monitoring and primary care settings Porting of products onto commercially established sample-to answer IVD platforms Continue development of new diagnostic companion blood test to guide personalized treatment of castration resistant prostate cancer

18 18 Outlook Continue to build on the ConfirmMDx momentum in the mid-term Tailored approach aimed at increasing market share. Drive SelectMDx long-term growth with numerous value driving inflection points in the coming years. MDxHealth confident about achieving higher rate of Product and Services revenue growth than in 2017 Too early in the financial year to predict the exact level of growth Company will update the market as the year progresses Management Remains Positive About the Outlook for 2018

19 2018 All rights reserved 19 Q&A 2017 full year financial results February 22, 2018