Molecular Diagnostic Solutions for Urologic Cancer - Dr. Jan Groen, President & CEO Mr. Jean-Marc Roelandt, EVP & CFO
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®
Molecular Diagnostic Solutions
for Urologic Cancer
Dr. Jan Groen, President & CEO
Mr. Jean-Marc Roelandt, EVP & CFO
2018 Corporate Presentation
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
OUR MISSION
Improve patient outcomes by delivering molecular
diagnostic solutions for urologic cancers
PROSTATE BLADDER KIDNEY
CANCER CANCER CANCER
589,679 242,273 176,500
new cases new cases new cases
THE LEADER IN MOLECULAR DIAGNOSTICS FOR URO-ONCOLOGY
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.MDXHEALTH LEADS MOLECULAR DIAGNOSTICS FOR UROLOGY
>100,000 240 >70
patients tested employees dedicated scientific publications
globally to MDxHealth global supporting the
15
YEARS
foot-print products
since the company
was founded in 2003
$319 Million > $100 Million >50%
market cap in revenue since lives covered for
Euronext; launch of first lead product
MDXH.BR product
42017 PRODUCT HIGHLIGHTS
11,700 Patients tested
EU Volume of 300%
4 New payor contracts
9 European distribution agreements
3 2 Clinical publications and 1 abstract
21,400 Patients tested
18 New payor contracts
2 Integrated Health Systems contracts
4 New payor contracts
6 3 Clinical publications and 3 abstracts
1 Clinical publication
5GROWTH STRATEGY
1 2 3 4
Drive tests adoption Increase the clinical Expand usability Precision diagnostics
with urologists and utility of SelectMDx tests through IVD through pharma
payors. Platform partnering
FOUR KEY PILLARS
The growing incidence of cancer globally
Demand for fast, actionable, cost-effective diagnosis and patient monitoring
6COMMERCIAL STRATEGY OVERVIEW
US Operations EU Operations
ü CLIA service lab (215 FTE’s) ü ISO service lab (25 FTE’s)
ü Laboratory developed test (LDT) ü CE-marked in-vitro diagnostic (IVD) kits
ü Large national sales force 42 reps ü Direct sales 5 reps
ü Reimbursement Medicare & commercial ü Distributors
7PRODUCT PIPELINE & MARKET OPPORTUNITY
R&D Validation Clinical Utility Launch Market $M
$555
$788
POC
$1,874
$431
$700
Kidney Cancer Assay Not
Disclosed
82017 TEST VOLUME AND REVENUE AT FULL REIMBURSEMENT
Booked Revenue at full
revenue Reimbursement
21,400 tests $26.4M $43M
11,400 tests $1.8M $3.4M
1,500 patient clinical validation study $0.0M $0.7M
Test under development
TOTAL PRODUCT REVENUE
$28.2M $47.1M
9PROSTATE CANCER CHALLENGES
Who needs Who needs Who needs
initial biopsy? repeat biopsy? treatment?
19M ~2.0M ~500,000 186,780 27,540
abnormal PSA prostate biopsy diagnosed with
PSA Screenings1,2 test results3 procedures4 prostate cancer5 Deaths6
1) Ross et al, Cancer Epidemiol Biomarkers Prev 2008 2) Cost Analysis of Screening for, Diagnosing, and Staging Prostate Cancer_CDC_2007 3) Lin et al., Ann Intern Med.
2008;149:192-199. 4) Mosquera et al, Clin Cancer Res 2009.pdf 5) Fadare et al, Arch Pathol Lab Med. 2004;128:557–560 6) American Cancer Society 2011IMPROVE PATIENT SELECTION FOR PROSTATE BIOPSY
Prostate Biopsy Remains the Gold Standard for Cancer Detection
PROSTATE
BIOPSIES
25%
false-negative results
18%
complications from biopsy
(e.g. bleeding, infections, etc.)
~3%
hospitalized within 30
days of biopsy
11 1) Gershman et al.; Eur Uro 2016, 2) Loeb et al.; Eur Uro 2013, 3) Loeb et al.; J Urol. 2011.VALUABLE LIQUID BIOPSY TEST FOR PATIENTS & PHYSICIANS
98% NPV for high grade prostate cancer
men with elevated PSA only 25%
2M at risk for high grade disease
ü Non-Invasive urine test
ü Identifies patient for MRI or biopsy
ü Avoiding 53% of unnecessary biopsies
Available as LDT and IVD Product
12Liquid Biopsy to Identify Patients for Prostate Biopsy
MRI / BIOPSY
Follow-up
Elevated PSA / DRE Urine Test ROUTINE PSA
Urine test for the prediction of histopathological outcome of prostate biopsy
13VALUABLE TISSUE BIOPSY TEST FOR PHYSICIANS & PAYORS
96% NPV for high grade prostate cancer
initial biopsy, 25% false negative,
500K 18% complications
ü Tissue test in NCCN guidelines
ü Medicare coverage
ü identifies men at risk for high grade disease
ü Avoiding 53% of unnecessary repeat biopsies
MDxHealth Lead Product
14TISSUE BIOPSY TO FORGO A REPEAT PROSTATE BIOPSY
MRI / BIOPSY
Follow-up
Pathology DNA Tissue Test ROUTINE PSA
initial negative biopsy
15PRODUCT SUCCESS SINCE LAUNCH
>20,000 >80,000
tests completed tests completed
since launch May 2016 since launch May 2016
List Price: $500 List Price: $3,300
16TOTAL ADDRESSABLE US MARKET
~7% Market Penetration
~320,000 ~$555M
Potential US Total Addressable
ConfirmMDx Market Market*
17REIMBURSEMENT TIMELINES
2 – 4 Years
Analytical Clinical Clinical Budget Clinical Payor
Validation Validation Utility Impact Study Guidelines Contracts
High
Real World Clinical Utility
Comparative Effectiveness
Clinical
Adoption Investigational Use
Test Commercially Available
Payor Involvement (PPO)
Low
Early Test Maturity (Level of Evidence) Established
18ESTIMATED PROSTATE BIOPSIES PAYOR COMPOSITION
8% Integrated Healthcare Systems
29% Medicare
52% Commercial
11% Medicare Advantage
19INCREASING COVERAGE
160
COVERED LIVES (MILLIONS)
120
80
40
0
2013 2014 2015 2016 2017
20BLADDER CANCER PORTFOLIO OPPORTUNITY
Who should be Who gets Who has
Who will recur? How to treat?
referred? cystoscopy? bladder cancer?
10M 1.8M >600,000 300,000 80,000
referrals to urology Cystoscopy Active Monitoring
HAEMATURIA PATIENTS Procedures CASES
21 1) David SA, et al. Urology 2017 Feb;100:20-26. 2) Loo R, et al. Mayo Clinic Proceedings 2013 Feb; 88:129–138 3) NCI SEER 2017VALUABLE TISSUE BIOPSY TEST FOR PATIENTS & PHYSICIANS
99% NPV for bladder cancer
10M Hematuria patients
ü Non-Invasive urine test
® ü Recommends cystoscopy or CT scan
ü Avoiding unnecessary cystoscopies
Available as LDT and IVD Product
22LIQUID BIOPSY TO IDENTIFY PATIENTS WITH BLADDER CANCER
CT Scan /
Cystoscopy
® Follow-up
Routine
Patient Urine Test Monitoring
blood in urine Runs on any open
PCR/Sequence instrument
232018 Q1 FINANCIALS 24
Q1 2018 FINANCIAL HIGHLIGHTS
>9,300 $9.7M $6.7M -$6.2M
Patients Tested Total Revenue Operating Loss EBITDA
Growth Over
Q1 2017 +55% +50% +$0.8M +$0.8M
CASH and CASH EQUIVALENTS OF $51.3M
25Q1 2018 HIGHLIGHTS
50% >167% 6 SelectM Dx in
OPERATIONAL Q1 volume SelectMDx
volume
New payors
EAU Guidelines
EXECUTION increase for
ConfirmMDx increase in
contracts
Europe
Sign global SelectMDx in
Published new
OTHER license with Liquid Biopsy
Dutch
BUSINESS LabCorp for test for CRPC
Reimbursement
MGMT system
26Q1 2018 VOLUME GROWTH
>9,300 total
patients
tested
(up 55% )
2017
>167%
SelectMDx
volume increase
since global
2018 launch
50%
ComfirmMDx
growth over
2,000 6,000 10,000 Q1 2017
ConfirmMDx SelectMDx (US) SelectMDx (EU)
27THE MARKET CONTINUES TO RESPOND POSITIVELY
Stock Exchanges MDXH: Euronext BR
MDXDHF: OTC
5.7% Capfi Delen
Total Shares
Outstanding 59,939,289
12.8% BioVest
Market Cap $3.56 - $6.75 3.3% BNP Parisbas
U.S. 12% Valiance
Taglich Brothers
51.9% Retail
Analyst Coverage Europe
Berenberg 14.3% Other Institutionals
Kempen
KBC
Degroof Petercam
Goetzpartners
YTD Share Facts Shareholders
28COMPELLING INVESTMENT THESIS
FUTURE GROWTH PIPELINE
Cancer incidence accelerating Established and fast growing Internal and external
with aging population specialty molecular uro- sourcing of new innovative
diagnostic business assets to build pipeline
Oncology is the fastest growing
area in diagnostics Three commercial products on Ongoing business
the market and tested >100,000 development efforts towards
patients pharma companies
Roadmap to profitability through Strong focus on IVD market
product sales ramp
VISION To be a leading molecular diagnostics for urologic oncology focusing on innovation
29UPCOMING NEWSFLOW
Q2 Q3 Q4
AUGUST 30, H1 RESULTS OCTOBER 23, Q3 RESULTS FEBRUARY 2019, Q4 RESULTS
SelectMDx 4M validation Clinical utility & budget impact Filling for Medicare coverage of
study studies SelectMDx
Product distribution agreements for Contracting with “sample-to-result” Publication of data to expand
Select & ConfirmMDx IVD platform partner for SelectMDx SelectMDx utitliy
Licensing agreement InformMDx Product distribution agreements for Distribution agreements
technology Select & ConfirmMDx ConfirmMDx and SelectMDx
30APPENDIX 31
2017 OVERVIEW
FINANCIAL 35% $28.2M $40.5
increase in total Product & in total
PERFORMANCE revenue Service revenue
Revenue
14% >300% 2
OPERATIONAL >33,100 Q4 volume SelectMDx integrated
increase for volume
EXECUTION patients tested
ConfirmMDx increase in
health system
contracts
Europe
32FY 2017 FINANCIAL
HIGHLIGHTS
~33K $40.5M $12.3M -$10.4M
Patients Tested Total Revenue Operating Loss EBITDA
Growth Since
FY 2016 +39% +35% -$0.5M +$0.7M
CASH COLLECTION INCREASE +17%CONTINUED
REVENUE GROWTH
$1.9M
17% 35%
2015 $15.8M increase
increase in
cash in total
collections revenue
from products
2016 $24.9M $5M & services to 91%
$23.1M of product &
service revenue
represented by
2017 $28.2M $12.3M ConfirmMDx
$16.8M
cash at
December
$10M $20M $30M $40M
31, 2017
P ro d u cts & S e rvice s O th e rCONTINUED STRONG
VOLUME GROWTH
2015 >33,000
total patients
tested
(up 39% )
2016 >300%
SelectMDx
volume increase
since global
2017 launch
14%
stronger Q4
performance
reflects
1 0 ,0 0 0 2 0 ,0 0 0 3 0 ,0 0 0
sales team
growth
C o n firm M D x S e le ctM D x (U S ) S e le ctM D x (E U )RESEARCH COLLABORATIONS
SUPPORT OUR PIPELINE
Develop and Development and Discovery and
validate blood validation of bladder development of
based test for CRPC cancer products kidney cancer assaysOUR INTELLECTUAL PROPERTY
25 ISSUED
PATENTS
38 20 PENDING
PATENTS
PATENT
FAMILIES
23
ISSUED
PATENTS
15
PENDING
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