Molecular Diagnostics for Urologic Cancer. H Corporate Presentation

Transcription

1 Molecular Diagnostics for Urologic Cancer H Corporate Presentation

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 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. 2

3 UROLOGY DIAGNOSTC MARKET THE LEADER IN MOLECULAR DIAGNOSTICS FOR URO-ONCOLOGY PROSTATE CANCER BLADDER CANCER KIDNEY CANCER MARKET 589,679 new cases 242,273 new cases 176,500 new cases > $3bn revenue MDXHEALTH IS THE ONLY COMPANY TO DEVELOP TESTS ACROSS THE ENTIRE URO-ONCOLOGY DIAGNOSTIC SPECTRUM GLOBOCAN (IARC) Population forecasts were extracted from the United Nations, World Population prospects, the 2012 revision. Numbers are computed using agespecific rates and corresponding populations for 10 age-groups.; management data, companies information, Frost and Sullivan equity research reports

4 H HIGHLIGHTS OPERATIONAL EXECUTION 30% Total volume increase >179% SelectMDx volume increase in Europe 15 New payors contracts 5 SelectMDx health economic studies published OTHER BUSINESS Sign global license with LabCorp for MGMT Published new Liquid Biopsy test for CRPC Sign global license with Philips for InformMDx SelectMDx in Dutch Reimbursement system 4

5 H FINANCIAL HIGHLIGHTS $16.6M Product Revenue (1) $10.0M Gross Profit (2) $15.0M Operating Loss (3) -$13.5M EBITDA (3) Growth Over H % +42% -$3.5M -$2.8M (1) Including $15.3M from ConfirmMDx and SelectMDx (2) On product and services revenue (3) H included non-recurring patent revenue of $12.1M, which is excluded from the change vs 2017 CASH and CASH EQUIVALENTS OF $40.9M 5

6 H VOLUME GROWTH H H % >20,000 total patients tested >179% SelectMDx volume increase in Europe 5,000 10,000 15,000 20,000 11% ConfirmMDx growth over ConfirmMDx SelectMDx (US) SelectMDx (EU) 6

7 PROVEN PRODUCT VOLUME SUCCESS VS. PEERS Cumulative number of tests x Product Launch Company MKT Product name Price Market Size $2,0 B Oncotype PCR $4, ,000 $464 M Afirma (Thyroid) $4, ,000 $3,3 B Polaris test $3, ,000* $250 M SelectMDx $500 2,800,000 ConfirmMDx $3, ,000 MDXHEALTH VOLUME GROWTH FAVORABLE TO PEERS Quarters from launch 7 Note: Product volume as measured by number of quarterly tests. Source: Management data; competitors public information

8 GROWTH STRATEGY Drive tests adoption with urologists and payors. Increase the clinical utility of SelectMDx Expand usability tests through IVD Platform Precision diagnostics through pharma partnering FOUR KEY PILLARS The growing incidence of cancer globally Demand for fast, actionable, cost-effective diagnosis and patient monitoring 8

9 CONFIRMMDX: TISSUE TEST ALTERNATIVE TO BIOPSY 75% of men undergoing biopsy have no or indolent cancer 320K Initial biopsy, 25% false negative, 18% complications ü Only tissue test identifying risk for high grade disease ü Clinically validated in >5,000 patients ü Identifies patients who may benefit from a MRI or biopsy ü >10,000 test performed in H ü 71 payor contracts ü Publication of ConfirmMDx in AA men Available as LDT and IVD Product 9

10 TOTAL ADDRESSABLE US MARKET ~7% Market Penetration ~320,000 Potential US testing marketing for ConfirmMDx ~$555M Potential US market 10

11 CONFIRMMDX REIMBUSREMENT ROADMAP AA men study Health Economic study economic Study Episcore study: 96% NPV Guidelines Launch MATLOC US Study MATLOC: 90% N DOCUMENT US validation study Medicare coverage EPI Health index data revealed NCCN Guidelines Medi-Cal approval GSA contract Kaiser agreement Medicare LCD expanded cove Unique CPT code PAYOR CONRACTS DRIVEN BY STUDIES AND GUIDELINES

12 INCREASING COVERAGE Contracts (Numbers) ConfirmMDx contracts Positive medical policy ConfirmMDx SelectMDx contracts ConfirmMDx in NCCN ConfirmMDx & SelectMDx in EAU guidelines 175 M lives covered for ConfirmMDx Medicare Coverage 18.6% SelectMDx 18.4% SelectMDx & ConfirmMDx % ConfirmMDx Product distribution ordering urologists 12

13 SELECTMDX: URINE TEST ALTERNATIVE TO BIOPSY 80% of men undergoing biopsy have no or indolent cancer 2M men with elevated PSA only 25% at risk for high grade disease ü Only urine test identifying risk for high grade disease ü Clinically validated in >4,000 patients ü Identifies patients who may benefit from a MRI or biopsy ü Included in the 2018 EAU Clinical Guidelines ü > 1,000 urologists have used the SelectMDx test; ~9,000 test performed in H ü 23 payor contracts ü Health economic study shows >$500 million annual of cost saving avoiding unnecessary procedures Available as LDT and IVD Product 13

14 POTENTIAL US MARKET OPPORTUNITY FOR SELECTMDX Urology 300k Men on active surveillance ~2.8M Potential US testing marketing for SelectMDx Urology 500k biopsy procedures Primary Care 2 million men with abnormal PSA ~$1.3B Potential US Market Based on MDxHealth management estimations 14

15 SELECTMDX COUNTRY SPECIFIC HEALTH ECONOMIC STUDIES US NL FR GR SP IT Male ~151 M ~8.5 M ~32 M ~41 M ~ 23 M ~29.5 M population (M) Per patient $1,694 $147 $1,402 $505 $284 $872 savings ($) Annual savings ($) ~$528M ~$3M ~$184M ~$68M ~$23M ~$120M Publication >$900M In annual healthcare savings compare to Biopsy

16 H US TEST VOLUME AND REVENUE AT FULL REIMBURSEMENT Booked revenue Revenue at full Reimbursement 10,425 tests* $14.2M $27.3M 4,850 tests* $1.1M $2.4M TOTAL PRODUCT REVENUE $15.3M $29.7M *billed cases in Full reimbursement is based on contracted rates and retail list price for non-contracted payors and amounts to a blended average of $2,618 and $500 per case for ConfirmMDx and SelectMDx, resp. 16

17 INFORMMDX: TISSUE TEST ADD ON TO GLEASON SCORE Identifies men with low grade disease who are likely candidates for Active Surveillance versus those that require immediate treatment 140K men with adverse pathology ü 1 gene RNA PCR test ü Clinically validated in 550 patients ü Global exclusive license with Royal Philips ü Covered by 40 patents ü 6 scientific publications In development as LDT 17

18 DEVELOPMENT OF INFORMMDX Gene discovery: meta analysis 32 tissue samples Validation set N= 550 Savings $2286/patient * Discovery Development Validation Health Economics Clinical Utility Post Launch PDE4D7 Gene Technical Validation Clinical validation Meta analysis * Data based on OncotypeDx for prostate, cost per test of $4180

19 PRODUCT SUCCESS SINCE LAUNCH >25,000 Tests completed since launch May 2016 >90,000 Tests completed since launch June 2012 > $100 M Product & Service Revenue since launch first test List Price: $500 List Price: $3,300

20 DRIVING PRODUCT AWARENESS THROUGH SOCIAL MEDIA EUROPE Patient & Urologist Specific Websites UNITES STATES Google AdWords & Facebook Ads EU ~ 18,000 Reviews in H US > 3.5 M Impressions in H1 2018

21 H1 FINANCIALS

22 H FINANCIAL PERFORMANCE ACROSS ALL INDICATORS Patient Test Volume Product & Service Revenue Product Gross Profit H1 FY 33,100 $24.9M $28.8M $14.9M $17.9M 24,000 15,000 15,000 20,100 $15.2M $10.9M $12.0M $16.6M $8.9M $6.5M $7.0M $10.0M 5,500 5,800 $6.9M $4.2M

23 CONSECUTIVE GLOBAL YEAR OVER YEAR TEST VOLUME GROWTH Tested over 20,100 patients globally o 30% increase year over year o 16% of volume from the EU o SelectMDx increased 67% compared to H o ConfirmMDx increased 11% compared to H Patient Test Volume H1 33,100 FY 24,000 20,100 > 17,800 billable tests 97% billable test in the US 40% billable test in Europe 5,500 15,000 5,800 15,

24 CONTINUED PRODUCT AND SERVICE REVENUE $17.2 M Total H revenue Product & Service Revenue o o 97% ($16.6M) of product and service revenue 89% ($15.3M) of revenue from ConfirmMDx and SelectMDx, of which 98% from US $24.4M $28.8M o One-time patent sale of $12.1M in H o $0.6M revenue from milestone and royalties $15.2M $15.3M Revenue from ConfirmMDX and SelectMDx of $15.3M, up 29% from H ConfirmMDx revenue of $14.2M, up 27% from H SelectMDx revenue of $1.1M, up 46% from H $11.9M $10.8M $6.9M

25 GROSS PROFIT Product Gross Profit Total gross profit of $10.5M, or 61% of total revenue Gross profit from products and services of $10M, up 42% from $7M in H Gross profit margin on revenue from products and services of 60% compared to 58% in H $17.9M $14.9M $10M $8.9M $7.0M $6.5M $4.2M

26 STRENGTHENED BALANCE SHEET AND DECREASE BURN Healthy balance sheet Cash of $40.9M at the end of H Raised $44 through an accelerated bookbuild in March 2018 US cash collections of $14.7M, up 35% compared to H Operating Expenses & Cash Utilization $18.7M $23.9M $25.5M $15 cash burn from operations in H and $1.3M CAPEX $16.7M $14.3M $16.6M compounded by unrealized foreign exchange translation losses of $1.7M H H H1 2018

27 27 Outlook

28 SUMMARY GROWTH Total test volume up with 30% Product & service revenue up 38% Cash collections up 29% Gross profit from products and services up 42% PIPELINE Ongoing business development efforts towards pharma companies Validation SelectMDx for AS and primary care Conversion from LDT to IVD market FUTURE Two LDT products in development InformMDx & MonitorMDx Completion SelectMDx studies for guideline inclusions SelectMDx Medicare coverage in 2019 VISION 28

29 29 Q & A