Investor Day September 2015

Transcription

1 1 Molecular Diagnostic Solutions for Urologic Cancer Investor Day September 2015

2 Agenda 2 Introduc)on and Company update Jan Groen Development and Valida)on of SelectMDx by Prof. Dr. Jack Schalken Commercial Opera)ons by Chris Thibodeau

3 3 Molecular Diagnostic Solutions for Urologic Cancer Company Presentation Dr Jan Groen, President & CEO Investor Day September 2015

4 Forward Looking Statement 4 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.

5 5 Delivering Epigenetic Diagnostics for Urological Cancers Providing physicians with the tools to improve the diagnosis and Locations Technology Personalized personalized treatment of their patients! US headquarters Irvine, CA! EU headquarters Herstal, BE Nijmegen, NL! DNA Methylation! mrna Expression! 30 issued patents & 25 pending applications! ClinicalMDx Clinical Cancer Testing! CE-Marked Kit

6 Company Highlights 6 Market leader in the fast growing field of cancer epigenetics with a focus on urology Revenue generating prostate cancer product, ConfirmMDx; bladder cancer product upcoming 2014 sales: $11.7M, 2015 FY sales est.$16.0m Over 30,000 patients tested since 2012 Three commercial stage epigenetic products on the US market Acquisition of Noviogendix B.V. Expansion of commercial portfolio into liquid biopsy segment of market

7 MDxHealth Strategy 7 Our Commercial Focus Ø Provide best in class molecular diagnostic solutions for urologic cancers Our mission is to improve patient outcomes by delivering molecular diagnostic solutions for urologic cancers Ø Capture market share in target indications Ø Establish reimbursement from payors Ø Expand clinical utility of our testing solutions Ø Introduce our products to international markets

8 Market Opportunity MDxHealth 8 Urologic Cancers in the U.S. $15B spent annually on the diagnosis and ++%"!%%& treatment of prostate cancer 1 in 7 men diagnosed with prostate cancer '(")%%& *#"%%%& Annual prostate cancer mortality of 27,540!"#$%& C0B)B* D7&"0/* E5+&&0$* =$%B#+#0*

9 U.S. Prostate and Bladder Cancer Market 9 $ Millions $300 $2,250 $250 $1,700 ConfirmMDx for Prostate Cancer ConfirmMDx for Bladder Cancer RecurMDx for Bladder Cancer Total Market Opportunity

10 10 Commercial Portfolio

11 2015 All rights reserved 11 ~1.3 Million Prostate Biopsies Annually in the United States 19M 4.7M >1.3M 241,000 27,540 PSA Screenings Abnormal PSA Results Biopsy Procedures Diagnosed with PCa Deaths Aubry W et al:. American Health Drug and Benefits (1): 15-24

12 ConfirmMDx for Prostate Cancer A tissue based LDT, to aid in the diagnosis of prostate cancer 12 ConfirmMDx provides urologists with actionable information to: Reduce unnecessary biopsies Identify men with clinically significant cancers in negative biopsy tissue

13 Our Current Business Model MDxHealth 13 Diagnosis Shipping Processes Reports Biopsy Sampling Accredited Results Urology Pathology Lab Physician

14 The Foundation of Exact Science s Cologuard 14 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 FDA-approved! The license agreement runs through 2028

15 PredictMDx for Glioblastoma 15 MGMT 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 Brain Cancer! Test required in newly diagnosed stage IV Glioma

16 16 Bladder Cancer R & D

17 17 I have hematuria! Does this mean I have cancer?! Who is at risk for bladder cancer?! How can you be sure?

18 2015 All rights reserved 18 Hematuria and Bladder Cancer in the USA Annually 7M 1M >700,000 72,500 15,000 Hematuria Patients Per Year Referred to Urology Cystoscopy Procedures Diagnosed Bladder Cancer Deaths

19 Bladder Cancer Standard of Care Diagnostic Modalities 19 Urine sample collected via urination or bladder wash Current methods for detection Cytology: examining cells in the urine of bladder cancer are often inadequate, leaving many Cystoscopy: key diagnostic procedure patients at risk for delayed diagnosis Histology of tissue biopsy

20 Liquid Biopsy Epigenetic Test Bladder Cancer 20 Comparison Sensitivity KGG* 97% Performance! 95% Negative Predictive Value JG* 76% 78% 82%! 86% Positive Predictive Value! 97% Sensitivity IG*! 91% Specificity 44% HG* FG* Cytology Fish NMP CxBladder ConfirmMDx BCa

21 21 Post Transaction NovioGendix

22 NovioGendix The Company Privately held R&D company founded (2007) Based in Nijmegen The Netherlands Founders Prof Dr. Jack Schalken and Dr. Willem Melchers BioGenera)on Ventures and PPM OOST major shareholders (2008) Spin- off from RUMC Radboud University Medical Center RUMC has focus on genito- urinary cancers

23 Location NovioGendix 23 Nijmegen, The Netherlands *!$47"0[*,+578%$"7+[*X9* *\0$B#+5[*E05S7'-*

24 Transaction Rationale & Financial Terms NovioGendix Acquisition 24!!!!! Mature product, (SelectMDx) for PCa Rich pipeline of new urologic cancer assays Unique clinical scientific collaboration with RUMC PCa test ready to be launched on US and EU market Complementary expertise between Noviogendix and MDxHealth!!!!! MDxHealth will purchase all outstanding shares of NovioGendix Full purchase price of $8.8M ("7.75M) $5.1M ("4.5 M) in new MDxH shares with waterfall lock-up periods of 3 and 18 months $3.3M ("3.0 M) is subject to milestone payments MDxHealth will repay NovioGendix debts of $680K ("600K)

25 25 MDxHealth Expanded Business & Product Strategy NovioGendix Acquisition `3C*!63*,`!a* LM3*,]* * ];+-.50B**,`!a*`+<B* *C0B)"S*X9* ]X^LAU* ];+-.50B**!63*,%-.+"70B* *:3;\** 9+50B*T%$(0* =+$#"0$B^37B#$7<'#%$B* 9+50B*,@+""05* ];7B)"S*S$%_7"S*$040"'0* Q0+$*#0$-*$040"'0*

26 SelectMDx for Prostate Cancer Non-invasive test for the decision to biopsy 26 Technology! Three gene Biomarker assay! Real time qpcr assay "!LDT under CLIA "!CE marked kit! Urine sample (non-invasive) Clinical Use! Reduce unnecessary prostate biopsies! Identify men with aggresive prostate US and EU Product Launch! Accurate at low PSA levels Expected in 2016

27 U.S. Prostate and Bladder Cancer Market Potential 27 cggg* $2,750 FbGG*,-.-/0-&1/&213314/5& FGGG* KbGG* KGGG* bgg* $500 $1,700 $250 $300 G* 9050(#:3;*8%$* =$%B#+#0*,+"(0$*,%"d$-:3;*8%$* =$%B#+#0*,+"(0$*,%"d$-:3;*8%$* E5+&&0$*,+"(0$* L0('$:3;*8%$* E5+&&0$*,+"(0$* C%#+5*a4+75+<50* :+$?0#*

28 28 Financials

29 Revenue Growth MDxHealth 29 Millions $16.0 $11.7 $7.6 $5.2 $3.6 FGKKe* FGKFe* FGKce* FGKHe* FGKb=* P = Results pending

30 H Performance MDxHealth Financials 30 #! Total revenue up 64% ($7.9M) #! ConfirmMDx revenue up 77% ($6.9M) #! Net loss decreased with 32% in H #! No debt #! $40M in cash and cash equivalents

31 31 $! ConfirmMDx Risk Score publication $! Introducing ConfirmMDx Risk Score $! Publication of bladder cancer validation test News Flow $! Expansion contracts US payors $! Publication of SelectMDx data *

32 Leadership Over 100 years of experience in diagnostics for oncology Dr Jan Groen President & CEO Chris Thibodeau EVP & CCO Philip Ginsburg MD EVP & CMO Joseph Sollee EVP & Corp Affairs Prof. Wim Van Criekinge Executive CSO Miriam Reyes Sr. VP of Lab Ops Francis Ota EVP of Finance

33 33 Molecular Diagnostic Solutions for Urologic Cancer Liquid Biopsy Strategy For Urological Cancers Prof. Dr. Jack Schalken Investor Day September 2015

34 Bio Prof. Dr. Jack Schalken 34 Molecular biologist trained at Radboud University, Nijmegen, NL 1986 Research director Urology Radboud University MC 1987 PhD, gene expression in human malignancies 1988 post doc Johns Hopkins Hospital 1996 professor of experimental oncology (University of Utrecht) 2002 professor of experimental urology (Radboud University MC) 2007 co-founder NovioGendix

35 Something About Me - Jack A Schalken :;40/<& =0;;-/>&?4@& AB@1C4/D& Research director ( 86)- and Professor of experimental urology (2001) Co- Founder Noviogendix (2006) Make a difference in diagnosis and treatment..personalized medicine..

36 36 Development of the Liquid Biopsy Concept PCA3 Discovery Proof of Concept PCA3 Launch Liquid Biopsy Concept Integrate All Experience/ Expertise in NovioGendix, Radboudumc Spin Off!history! 12 September 2002

37 37 Prostate Cancer The Need for Non-Invasive Testing

38 38 What is a Liquid Biopsy? $! Sample that can be obtained non-/minimally invasive! Urine! Blood $! In that sample determine biomarker levels $! These are indicative for disease Liquid Biopsy

39 39 Early Diagnosis of Prostate Cancer Identification of Biomarkers to Identity Patients with Clinically Significant Prostate Cancer Using a Liquid Diagnostic Substrate Obtained Non-Invasively Liquid Biopsy

40 Prostate Cancer Test to Select Patients for Biopsy 40 Age 50 Elevated PSA Urologist DRE Urine Biopsy

41 41 Intended Use of SelectMDx for Prostate Cancer Urine test for the prediction of histopathological diagnosis of prostate biopsy Particularly, the identification of patients with clinically significant prostate cancer, using a sample that can be obtained non-invasively

42 A Stepwise Approach for the Identification and Validation of 42 SelectMDx Molecular Profiling $! GeneChip 1.0 ST array $! Frozen normal prostate and PCa tissue (n=99) cf* Biomarkers Selected Testing biomarkers on different cohort of tissue $! qpcr $! RNA from frozen normal prostate and PCa tissue (n=107) ch* Biomarkers Selected Testing biomarkers on a cohort of urine samples $! qpcr $! mrna from urinary sediments (n=16) J* Biomarkers Selected Testing biomarkers in intention-to treat cohort of urine samples $! qpcr (Laboratory Diagnostic Test) $! mrna from urinary sediments (n=358) c* Biomarkers Selected

43 SelectMDx for Prostate Cancer Provides actionable results to help guide the decision for biopsy 43 >10 ng/ml Biopsy Bx Serum PSA 3-10 ng/ml Cut Off <3 ng/ml PSA Follow Up No Bx!"#$%&'(#$%)*%+,-(#'$.%$"/*-'(

44 SelectMDx Score SelectMDx Score Subjects (#) < >

45 45 SelectMDx Outperforms PCA3 90"B7)47#/* The ROC curves for:! PCA3 (Progensa) AUC = 0.65 E*9050(#:3;* E*=,ac* >>>*L080$0"(0*57"0*! SelectMDx AUC = (7d(7#/*

46 46 SelectMDx Performance at Low PSA Values G>JG* G>Ob* AUC ( GS # 7) G>OG* G>Ib* G>IG* B=9a* 9050(#:3;* G>bb* G>bG* Serum PSA # of Subjects g*b***** IF********* g*o>b** KOf*********** g*kg* FHI* g*kf>b** FfF******** g*kb*** cgb******** a55*,+b0b* cbj*

47 47 SelectMDx Product Development ='<57(+)%"*hK*FGKb*

48 48 Validation SelectMDx in Independent Cohort ROC of SelectMDx Performance for Diagnosis GS#7 in NG0901 and NG1201 studies

49 49 USP for SelectMDx for Prostate Cancer Proprietary signature with better performance than PCA3 SelectMDx accurate at low PSA values Reduction in over-diagnosis

50 50 Conclusion NovioGendix has developed a prostate cancer biomarker test ( SelectMDx ) which is now in pre-launch phase NovioGendix has a biomarker pipeline addressing significant clinical dilemmas

51 51 Molecular Diagnostic Solutions for Urologic Cancer Commercial Operations Mr. Chris Thibodeau, CCO Investor Day September 2015

52 Prostate Cancer Challenges Unmet Clinical Needs 52? 1.3 million 27,540 biopsies 241,000 Diagnosed ~1 million w/neg biopsy ~25% with a false negative Deaths w/cancer biopsy Who needs Who needs Who needs Biomarkers initial biopsy? repeat biopsy? intervention? Aubry W et al:. American Health Drug and Benefits (1): 15-24

53 Unmet Medical Needs in Prostate Cancer 53 Survey of Key Opinion Leaders F-G&HI1/14/&J-7<-;& K/5C>0>-& L1:M31:M>5& a5+"*=+$)"[*:3* ]$7(*U+550"[*:3* X$%5%S7B#* L+/-%"&*`+"(0[*:3* E+5)-%$0* E+5)-%$0* X$%5%S/*%8*67$S7"7+m* ]+B#0$"*67$S7"7+* Q%$8%5?[*6a* N/B->&=31/1873&O--<&4P&N;434:15>5&7/<&Q7>M434:15>5& $! 0''1(.%$(2'3'$(14/)*%+,-(5%%6(5%(/7)"'*5(#/58%6%)9( 9+-B%"*T7"0[*:3* ].B#07"*+#*1\X* :0-%$7+5*95%+"* D0n0$7"S*,+"(0$*,0"#0$[*Q0_*e%$?*,7#/* $!!"#$%&'(/--7$/-9(%.(*%"%)$/"+(:(#$%&41'(-64*4-/669(7+'.76(4*.%$"/,%*( 'B08'5>**!*&%*"%#*?"%_*%8*+"/*(%-.+"/*+()405/*_%$?7"S*%"*+*)BB'0V<+B0&*#0B#>Z* $! ;$%&41'(/++'++"'*5(%.(57"%$(/))$'++4&'*'++(5%(/7)"'*5(<6'/+%*(=-%$'( $! `0%"*9'"[*:3** X$%5%S7B#[*+"&** 1+B%"*200[*:3* A"(%5%S7B#* 3'?0*X"740$B7#/* :0&7(+5*,0"#0$* %"0>Z*

54 54 Introducing

55 55 Improve Patient Selection for Biopsy >1 million men have negative initial prostate biopsy

56 Need for Biomarkers to Improve Patient Selection for Prostate Biopsy 56 USPSTF Recommends Against PSA Screening Over 1 million men will have a negative prostate biopsy result each year! Kbk*_755*B'W0$*(%-.57(+)%"B*8$%-*<7%.B/********************* N0>S>*<500&7"S[*7"80()%"P*! b>fk*_755*<0*@%b.7#+57i0&*7"*cg*&+/b*8%55%_7"s*<7%.b/**! Fbk*_755*$0(0740*8+5B0V"0S+)40*$0B'5#B*!-+S0*8$%-*aa,L*T%'"&+)%"*

57 SelectMDx for Prostate Cancer Improve Patient Stratification on the Decision for Initial Biopsy 57 SelectMDx provides urologists with actionable information to:! Liquid Biopsy

58 SelectMDx for Prostate Cancer 58 A urine-based, liquid biopsy test to identify patients for initial prostate biopsy!"#$%&'()*% a*"%"v7"4+b740*#0b#*#%*7-.$%40*.+)0"#*b050()%"r*,%$$05+)%"*_7#@*=$0&7()%"*%8*\7s@v2$+&0*=$%b#+#0*,+"(0$*%"*e7%.b/*! Low-risk men who may avoid biopsy! High-risk men who benefit from biopsy 9050(#:3;*L7B?*9(%$0r*! `%_*B(%$0*s*&0($0+B0&*$7B?*8%$*+SS$0BB740*(+"(0$*,%$$05+)%"*_7#@*250+B%"*9(%$0*! \7S@*B(%$0*s*7"($0+B0&*$7B?*8%$*+SS$0BB740*(+"(0$* ='6'-5:3;*9(%$0*!&0")d(+)%"*%8*+*,+"&7&+#0*20"0*=+"05*8%$*#@0*]+$5/*37+S"%B7B*%8*=$%B#+#0*,+"(0$>*`0/#0"*0#*+5>*,57"*,+"(0$*L0B[*FGKb *

59 59 An Epigenetic Assay to Improve Patient Stratification on the Decision for Repeat Biopsy

60 60 False-Negative Prostate Biopsy Challenge ~25% of time initial prostate biopsy misses cancer

61 False-Negative Biopsy Challenge Standard of Care (SOC) 61 TRUS Guided 12 Core Biopsy! Needle may miss cancer! Pathologists can only interpret what is on the slide! Follow up is a repeat biopsy A biopsy procedure samples less than 1% of the entire gland 1) Taneja et al: AUA Optimal Techniques of Prostate Biopsy and Specimen Handling ) Shen et al: J. Ultrasound Med. 2008; Jun; 27(6):

62 Fear of Undetected Cancer Leads to High Rate of Repeat Biopsy 62 Unnecessary Repeat Biopsies 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 1) Welch HG et al: J Natl Cancer Inst 2007;99: ) Pinsky PF et al: BJU International 99, no. 4 (April 2007):

63 MDxHealth Lead Product ConfirmMDx for Prostate Cancer 63 A tissue based LDT to aid in the diagnosis of prostate cancer ConfirmMDx provides urologists with actionable information to:! Reduce unnecessary repeat biopsies! Identify men at increased risk for clinically significant prostate cancer

64 How ConfirmMDx Works 64 ConfirmMDx detects an epigenetic field effect associated with the presence of cancer at the DNA level Field Effect Cancer Biopsy Henrique R, et al; Mol Cancer Res 2006;4:1-8

65 ConfirmMDx for Prostate Cancer 65 Most Significant Predictor for High Grade Prostate Cancer on Repeat Biopsy Odds Ratio for GS # 7 PCa KJ>G* KI>G* Multivariate Logistic Regression Analysis 15.8 KH>G* KF>G* KG>G* J>G* I>G* H>G* F>G* G>G* Age % + Biopsies PSA Atypia ConfirmMDx Risk Score Clinical Risk Factors 6+"*,$70?7"S0*0#*+5m*QA:,,r*FKbVFKI**FGKb*aXa*=$%B#+#0*,+"(0$r*30#0()%"*+"&*9($00"7"S*6**

66 ConfirmMDx for Prostate Cancer Patient Management 66 Routine Screening Methylation Negative Low Risk Score Active Follow Up Negative Prostate Biopsy ConfirmMDx Methylation Positive High Risk Score Repeat Biopsy Risk Score Van Criekinge et al; NOMCC: AUA Prostate Cancer: Detec)on and Screening V

67 67 Commercialization Strategy

68 Prostate Cancer in the United States Where MDxHealth Prostate Biomarkers are Indicated 68 Abnormal PSA 4.7M Results Prostate Biopsies 1.3M Performed Prostate Cancer 240K Detected Death from 27K Prostate Cancer!"&7(+)%"* Who to biopsy (Elevated PSA) Who to re-biopsy (Negative biopsy result) Who to treat (Positive biopsy result) Who to treat (Post prostatectomy) E7%-+$?0$B*,%-.0))%"* PSA, PCA3, Phi, 4k PSA, PCA3, Phi, 4k Oncotype DX, Prolaris Prolaris, Decipher

69 Commercialization Considerations 69 Visibility Strong brand & market validation Large national sales force > 45 scientific publications Strong KOL support National marketing partners Credibility > 30,000 test ordered > 2,000 ordering urologists Covered by many health plans Medicare covered

70 US & EU Commercialization 70 Considerations * US! Laboratory developed test! Large national sales force! Established client base! Reimbursement experience! Strong KOL support EU! CE marked in-vitro diagnostic kits! Direct sales! Distributors! Reimbursement: gov, private ins, patient

71 MDxHealth Sales Direct and Partners 71 WA ME CA OR NV ID UT MT WY CO ND SD NE KS MN IA MO WI IL MI IN KY OH WV VT NH MA NY CT RI PA NJ DE DC MD VA NC Overview! Direct National Sales Force! Co-marketing Agreements AZ NM OK AR TN GA SC! Establishing ROW Distribution Network MS AL TX LA FL MDxHealth (28) Bostwick (20) Miraca (21)

72 2015 All rights reserved Distribution of Urologists Ordering ConfirmMDx Since Product Launch OF*

73 US Sales Strategy Distribution* * 73 Sales Focus -! Focus on existing ConfirmMDx clients (>2,000 urologists) -! Academic, LUGPA, and community urology practices Method -! Strategic and Face-to-Face Selling Techniques -! Leverage KOL support and journal publications -! Utilize marketing collateral Goal Universe [email protected]&>M-&R0//-3& K/&>M-&R0//-3& 6-5>&R-S& Closed Prospecting Qualifying Analyzing Needs Value Proposition Resolving Concerns Gaining Commitment -! Gain market adoption and acceptance -! Enhance client relationships with expanded offering -! Drive volumes and revenues for testing services

74 Marketing Strategy Promotion* * 74 T>;7>-:18&U;1.-;5&& -! Prostate Cancer Key Opinion Leader Guidance -! MDxHealth s Speakers Bureau,`!a*^*,a=* -! Clinical Advisory Board Meetings -! Scientific Publications/Journal Articles -! Reimbursement/Managed Care Strategy :0&7(+$0* -! Patient Advocacy * ='<57(+)%"B* OH*

75 Marketing Strategy Promotion* * 75 Q;4B4C4/73&U;1.-;5& -! Marketing Collateral/Tools -! Industry Conference & Trade Show Exhibiting -! Social Media -! Public Relations Media Outreach -! Advertising -! Website Optimization (SEO)

76 ConfirmMDx Payer Mix (US) Selected Payers Reimbursing for Testing 76 Kk*Kk* cfk* cck*,%--0$7(+5* :0&7(+$0*a&4+"#+S0* :0&7(+$0* C$7(+$0* :0&7(+7&* cck*

77 77 Questions

78 78 Many thanks for your attention