interpace diagnostics group presentation
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Interpace Diagnos/cs PRESENTATION, DECEMBER 2017
IDXG
Forward Looking Statements ThisInvestorPresenta/oncontainsforward-lookingstatementswithinthemeaningofSec/on27AoftheSecuri/esActof1933,Sec/on21EoftheSecuri/esExchangeActof1934andthePrivateSecuri/esLi/ga/onReformActof1995,rela/ngtoInterpaceDiagnos/cGroupInc.’s(“theCompany”)futurefinancialand opera/ng performance. The Company has aTempted to iden/fy forward looking statements by terminology including "believes," "es/mates,""an/cipates,""expects,""plans,""projects,""intends,""poten/al,""may,""could,""might,""will,""should,""approximately"orotherwordsthatconveyuncertaintyoffutureeventsoroutcomestoiden/fytheseforward-lookingstatements.Thesestatementsarebasedoncurrentexpecta/ons,assump/onsanduncertain/esinvolvingjudgmentsabout,amongotherthings,futureeconomic,compe//veandmarketcondi/onsandfuturebusinessdecisions,allofwhicharedifficultor impossible topredictaccuratelyandmanyofwhicharebeyond theCompany's control. These statementsalso involveknownandunknownrisks,uncertain/esandotherfactorsthatmaycausetheCompany'sactualresultstobemateriallydifferentfromthoseexpressedorimpliedbyany forward-looking statement. Known and unknown risks, uncertain/es and other factors include, but are not limited to, the Company's ability toadequatelyfinancethebusiness,itsabilitytorestructureitsliabili/esandotherobliga/ons,themarket'sacceptanceofitsmoleculardiagnos/ctests,itsability to retain or secure reimbursement, its ability to secure addi/onal business and generate higher profit margins through sales of its moleculardiagnos/ctests,in-licensingorothermeans,projec/onsoffuturerevenues,growth,grossprofitandan/cipatedinternalrateofreturnoninvestmentsandourability tomaintainourNASDAQ lis/ng.Addi/onally,all forward-lookingstatementsaresubject to the risk factorsdetailed from/meto/me in theCompany'sfilingswiththeSecuri/esandExchangeCommission(SEC),includingwithoutlimita/on,theAnnualReportonForm10-KfiledwiththeSEConMarch31,2017andtheamendmentonForm10-K/AfiledonApril28,2017,theCompany’sQuarterlyReportsonForm10-QfiledwiththeSEConMay12,2017, August 10, 2017, and November 13, 2017, and the Company’s Registra/on Statement on Form S-1 (333-218140, the “registra/on statement”).Becauseof theseandother risks,uncertain/esandassump/ons,unduerelianceshouldnotbeplacedonthese forward-lookingstatements. Inaddi/on,thesestatementsspeakonlyasofthedateofhereofand,exceptasmayberequiredby law,theCompanyundertakesnoobliga/ontoreviseorupdatepubliclyanyforward-lookingstatementsforanyreason.TheCompanyhasfiledtheRegistra/onStatement(includingapreliminaryprospectus)withtheSecuri/esandExchangeCommission(SEC)fortheofferingforwhichthisInvestorPresenta/onrelates.Beforeyouinvest,youshouldreadthepreliminaryprospectuscontainedintheCompany’sRegistra/onStatementandotherdocumentstheCompanyhasfiledwiththeSECformorecompleteinforma/onabout the Company and this offering. The preliminary prospectus and the Registra/on Statement may be accessed through the SEC’s website atwww.sec.gov.Alterna/vely,theCompany,anyunderwriteroranydealerpar/cipa/ngintheofferingwillarrangetosendyouthepreliminaryprospectusifyourequestitthroughMaximGroupLLC,405LexingtonAve,NewYork,NY10174,ATn:ProspectusDepartmentorbyTel:(800)724-0761. ThisInvestorPresenta/oncontainssta/s/csandotherdatathathasbeenobtainedfromorcompiledfrominforma/onmadeavailablebythirdpar/esserviceproviders.TheCompanyhasnotindependentlyverifiedsuchsta/s/csordata.
Weareafullyintegrated“commercial”companythatprovidesmolecularanddiagnos8ctestsand
pathologyservicestoevaluatetheriskofcancerbyleveragingthelatesttechnologyinpersonalized
medicineforbe<erinformedclinicaldecisionsandimprovedpa8entmanagement.
Our Mission
Investment Highlights
NASDAQListedLiquidStock
InternalReimbursementCapabili>es
DedicatedSalesOrganiza>onof
26
Raised~$20MSinceEndDec
2016
MedicareandPrivate
Insurancecoverage
39%YoY(2015vs.2016)
RevenueGrowth
Long-termDebtFree
4ProductsInTheMarket
Inconclusive Biopsy: Uncertainty Drives Need for Molecular Tes/ng
IndeterminateResults
DiagnosticBiopsy
Unnecessary Surgeries
Wrong Treatment
DelayedTreatment
MolecularDiagnos>csimprovepa>entoutcomesandresultinsignificantcost
savingstothehealthcaresystem
Molecular Diagnostics
ImprovedOutcomes
Significant Cost Savings
Appropriate Surgery
Non-SurgicalFollow up
Therighttreatmentforthepa8ent
attheright8me
APrac/ve Molecular Business Model
VersusDrugs,Diagnos>cshave:- LowerDevelopmentalCosts- LowerDevelopmentalRisk
- Faster8metomarket
- Lowerregulatoryhurdles
2014AmericanThyroidAssocia>onRevisedGuidelinesMolecularDiagnos8cstestsshouldbeconsideredforsuspicionofmalignancyorindeterminate.
2013NCCNGuidelinesMolecularDiagnos8csrecommendedtes8ngonsomeindeterminatecytologiestominimizeunnecessarysurgeries
2016ASGEGuidelinesRecommenda8onno.4suggestsuseofPancraGenshouldbeconsideredwhencystsareindeterminatebasedoncytology
CurrentPancrea>cCystsGuidelinesSendaiguidelines2012andACGguidelines2007stronglyfavorsurgicalresec8onbecauseoftheinabilityoffirst-lineteststopredictbiologicalbehaviorandaggressiveness.
De-RiskedBusinessModel StrongGuidelineSupport
Drugs&
Diagnos+cs&
Development&Costs&
Development&Timelines&
Regulatory&Risk&
$800M+&
$3M&
8>10&yrs&
1>3&yrs&
FDA&Review&
LDTs&
(includingFDAreview)
Risk-Stratifies
Pancreatic Cysts
Over 71M Lives Covered
Integrated Molecular
Pathology test
Risk-Stratifies
Barrett's Esophagus
Soft Launch Began In 2017
Integrated Molecular
Pathology test
NGS panel for
Thyroid Cancer
Over 250M Lives Covered
Rules In Thyroid Cancer
Micro-RNA Classifier
Over 250M Lives Covered
Rules Out Thyroid Cancer
Interpace Diagnos/cs’ Product PorRolio
$300M-$370M*Pancrea8cCysts
$1.5B-$2B*Barre<’sEsophagus
$350M*ThyroidNodules
$350M*ThyroidNodules
*TotalMarketopportunity,CompanyEs8mates,www.endocrineweb.com,C.Huretal.Gastroenterology,(May21,2012).
Lung Cancer: Metastatic vs.
Primary
Medicare Coverage in
place
Integrated Molecular
Pathology test
Upto$90M*MVPLung
Pricing & Reimbursement
PANCREATIC CYSTS CANCER RISK POWERED BY PathF inderTG®
Pancrea/c Cancer NumberofNewUSCasesin2016:
45,000
◉ TheThirdLeadingU.S.CancerKiller
h<ps://seer.cancer.gov/stacacts/more.html
NumberofUSDeathsin2016:
43,090
◉ 5-yearsurvivalrate7.2%
NumberofNewUSCasesin2017:
43,090
16,870' 20,140' 24,500' 26,730'
40,610' 43,090'50,260'
155,870'
Bladder'Cancer'
Non8Hodgkin'Lymphoma'
Leukemia' Prostate'Cancer'
Breast'Cancer'(Female)'
PancreaIc'Cancer'
Colon'and'Rectum'Cancer'
Lung'and'Bronchus'Cancer'
PancraGEN Integrated Molecular Pathology
Imaging Cytology FluidAnalysis
MolecularDiagnos>cs
PathologistReview
PancraGen%[95%CI]
Sendai2012model%[95%CI]
PvalueforPancraGenvs.Sendai2012model
NPV 97.2[95.1-98.6] 97[93.7-98.9] 0.88
PPV 57.9[47.3-68.0] 20.8[16.2-25.9] <0.0001
ResultspublishedinleadingGIjournal,Endoscopy
PancraGENcaniden>fynon-progressorsaswellas2012Interna>onalSendaiGuidelines,howeverit’ssignificantlybeceratiden>fying
progressors
Elurietal.AmJGastroenterol2015;110:828–834;doi:10.1038/ajg.2015.152(9)
Significant Clinical Evidence
1Al-HaddadMA,KowalskiT,SiddiquiA,MertzHR,MallatD,HaddadN,MalhotraN,SadowskiB,LybikMJ,PatelSN,OkohE,RosenkranzL,KarasikM,GoliotoM,LinderJ,CatalanoMF.Endoscopy.2015Feb;47(2):136-46.doi:10.1055/s-0034-1390742
5ClinicalValida8onPapersPublished4ClinicalU8lityPapersPublished
1RegistryStudypublished5CostBenefitStudiesPublished
BudgetImpactModel
PancraGENestablishesanewstandardfortheprognosisanddiagnosisofpancrea>ccysts
Sendaiguidelines2012andACGguidelines2007stronglyfavorsurgicalresec8onbecauseoftheinabilityoffirst-lineteststopredictbiologicalbehaviorandaggressiveness.
PancraGEN Adop/on & Growth
ü250PhysiciansandHospitalsü Over30,000testsperformedü Interna8onalDistribu8on
Medicare
ENDOCRINE ONCOLOGY
Thyroid Nodules
^AmericanCancerSocietyh<p://www.cancernetwork.com/thyroid-cancer/thyroid-nodules-when-biopsy^* https://seer.cancer.gov/statfacts/html/thyro.html
56,870es>matednewcasesofthyroidcancerin2017.*
PrevalenceofThisCancer:In2014,therewereanes>mated726,646peoplelivingwiththyroid
cancerintheUnitedStates.*
ThyroidCancerIncidence*
◉ ~10-18MU.S.adultshaveNodules^◉ Es8mated525,00thyroidFineNeedle
Aspirates(FNAs)peryearintheU.S.andgrowing
Clinical Dilemma of Indeterminate Thyroid Nodules
Fina
l sur
gica
l pat
holo
gy d
iagn
osis
1,2
Non Diagnostic Benign Indeterminate* Malignant
Cytopathology Diagnosis
12%$6%$
23%$
62%$
97%$
77%$
0%#
20%#
40%#
60%#
80%#
100%#
Suspicious for Malignancy
*Indeterminate(FollicularLesion2)includesAtypiaofUndeterminedSignificance(AUS)/FollicularLesionofUndeterminedSignificance(FLUS)and(suspiciousfor)Hürthle/FollicularNeoplasm
1GharibH,etal.EndocPract2010.2WangCC,etal.Thyroid2011.
MolecularTes>ngValue:PreventUnnecessary
Surgeries
Data Comparison with Market Leader Test performance
[95% CI]
Combined mutation & miRNA testing
(ThyGenX + ThyraMIR)*
Mutation testing alone
(ThyGenX)*
Gene expression classifier with mRNA testing^
(Afirma®)
PPV(%) 74%[58-86] 81%[54-96] 47%[40-55]37%[23-52]
NPV(%) 94%[85-98] 64%[47-79] 93%[86-97]94%[79-99]
*Labourieretal.JCEM2015.^Alexanderetal.NJEM2012
ThyGenX™andThyraMIR™combina>ontes>ngcanaccurately“Rulein”and“Ruleout”theriskofmalignancy
ThyraMIR™measurestheexpressionof10microRNAsand,andthecombina>onwithThyGenX™,yieldsbothhighNPVandhighPPV
OnlycommercialtestthatcanbeperformedfromFNAand/orCytologySlides
ThyGenX™andThyraMIR™combina>ontes>ngaddressesaunmetclinicalneedformoreac>onableinforma>oninthemanagementofindeterminatethyroidnodules
Mul/ple Publica/ons Support Clinical Validity and U/lity of ThyGenX / ThyraMIR
ThyGenX / ThyraMIR Strong Adop/on & Growth
ü400PhysiciansandHospitalsü Over15,000testsperformedü LabCorpPartnershipü Interna8onalDistribu8on
Medicare
BARRETT’S ESOPHAGUS RISK OF PROGRESSION TO CANCER POWERED BY PathF inderTG®
What is BarreP’s Esophagus? ◉ Gastroesophagealrefluxverycommon(10-20%USadults)◉ 6%progresstoBarre<'sEsophagus(~3.3millionadults)
◉ Barre<'sEsophagusprecedesesophagealcancer(EAC)infrequently(1-3%)
◉ Abla8on(Barrx)hasemergedasatreatmentandpreven8onstrategy
◉ Currenttestscannotpredictwhichpa8entswillprogresstoEsophagealCancer–oneofthemostlethalcancers–crea8ngahighunmetneedforamoleculardiagnos8ctest
How May BarreGEN Be Useful?
BarreGENcanallowformorepersonalizedmanagementofBarrec’spa>ents
AidInstrategiesto
preventcancerbyabla>on
Avoidunnecessary&expensive($30K)
recurringabla>on
Helpmonitorpa>entsduring
surveillance
Reduceoverallcostofcare
BarreGEN for BarreP’s Esophagus
$1.5-$2BPoten8al
~3.3MAdults
~850,000EndoscopicscreensAnnually
Source:Indica8onsandOutcomesofGastrointes8nalEndoscopy,2009
PathfinderTG®plarormBarreGENClinicalExperienceProgram(CEP)launchedSeptember1st,2016
Mul/ple Publica/ons Support Clinical Validity and U/lity of BarreGEN
METASTASIS VS. NEW PRIMARY CANCER - LUNG POWERED BY PathF inderTG®
MVPdx
222,500NewlyDiagnosedCases/Year
No.1LeadingCauseofDeathinMen&Women
No.2NewCancerIncidenceinBothMen&Women
Lung Cancer Sta/s/cs NumberofNewUSCasesin2017:
222,500
◉ LeadingU.S.CancerKiller
h<ps://seer.cancer.gov/stacacts/more.html
NumberofUSDeathsin2017:
155,870
◉ 5-yearsurvivalrate18.1%
16,870' 20,140' 24,500' 26,730'
40,610' 43,090'50,260'
155,870'
Bladder'Cancer'
Non8Hodgkin'Lymphoma'
Leukemia' Prostate'Cancer'
Breast'Cancer'(Female)'
PancreaIc'Cancer'
Colon'and'Rectum'Cancer'
Lung'and'Bronchus'Cancer'
MVPdx (Lung Cancer) ClinicalIndica>ons• Comparethemuta>onalfingerprintoftwoormore
cancersitestodeterminerecurrence/metastasisornewprimary(independent)cancer• DefinePrimarysiteofforma8oninrela8onshipto
mul8plemetasta8cspread• Differen8atemul8-centriccarcinomaversusintra-
organspreadofonecancer• Differen8atelocalreoccurrenceversusintra-
organcancerforma8on
*BasedonCurrentMedicareReimbursement
MVPdx Lung 600+ Tests Performed To Date
Requisi8on SampleReport
MVPdx Suppor/ve Publica/ons
MVPdX Adop/on
ü 5BetaHospitals–Northeastü Over600testsperformed
Medicare
FINANCIAL AND CORPORATE REVIEW
Select Financial Informa/on IncomeStatement 2016 2015 Q32017 Q32016 Q32017
YTDQ32016YTD
Revenue $13.1 $9.4 $4.2 $3.3 $11.5 $10.0
GrossProfit $6.4 $2.5 $2.1 $1.5 $5.8 $5.1
TotalOpera8ngExpenses $12.9 $42.9 $5.2 $8.0 $8.8 $18.3
LossfromCon8nuingOps ($8.4) ($31.1) ($3.4) ($7.2) ($7.8) ($14.7)
BalanceSheet
CashBalance(EndofPeriod) $0.6 $8.3 $11.7 $1.7
AccountsPayableandAccruedExpenses
$12.1 $9.9 $7.0 $11.4
Stockholders’Equity $6.5 $13.0 $36.4 ($1.5)
(InUSMillion)
Source:SECFilings,10-K
Patent PorRolio and Proprietary Assets
Thyroid 2USpatentspending,5ex-USPatentsPending
Pancreas
Barrett’s Esophagus
Proprietary
Extensiveexperienceinmanagingextremelylowquality,fixa>vetreatedclinicalspecimens.
Labinforma>onmanagementsystemthatextractsresultsfromdatabaseandallowsefficientintegra>onofmolecularandclinicalresults.
ProprietaryAlgorithmforThyraMIRClassifier.
Proprietaryextrac>onandmicrodissec>on,methodologyfromslides,BufferandFFPEsamples.
5patentsIssued
2patentsPending
Lung ProprietaryAlgorithm
Experienced Management Team
JackStoverPresident,CEO
GregRichardChiefCommercialOfficer
SydFinklestein,MDChiefScien8ficOfficer
JimEarlyVPCFO
GlennGershonSr.VP.Opera8ons
AlidadMireskandari,Ph.D.VPBusinessDevelopment
Commercial◉ AETNANa8onalContract◉ CignaCoverage◉ OxfordCoverage◉ UnitedHealthCoverage◉ NYStateApprovalForThyGenX◉ LaunchedInterna8onal
Distribu8ons◉ EUPatentGrantedforThyraMIR◉ LabCorpCo-Promo8on◉ +250MThyroidlivescovered◉ +71MPancreasLivescovered◉ LabServicesAgreementsigned
withEinsteinMedicalCenterJune5th,2017
◉ LabServicesHoagHospital,CA
Recent Accomplishments Corporate
◉ RevenueGrowth39%Y-O-Y
◉ Raisedover$14MinEquity
◉ Converted$9MInSecuredNotesintoStock
◉ Eliminatedmilestonepayments,liens&royal8esrelatedto2014RedPathAssetsAcquisi8on
◉ ReducedCashBurn$20MY-O-Y2015to2016
Clinical◉ LaunchednewBiliaryproduct
October3rd,2016
◉ LaunchedAccuCEA™InsightsAugust1st,2016
◉ LaunchedPanDNAMarch,2017
◉ LaunchedBarreGen®ClinicalExperienceProgram(CEP)September1st,2016,andSo�launchedBarreGenatselectsites
◉ LaunchedCytopathologyServicesOctober1st,2016
◉ LaunchedCytologySlidesasprimaryspecimenOctober1st,2016
◉ LaunchedTERTmarkerofaggressivenessJune1st,2017
2017/18 Key Drivers of Growth
InternalDriversContractwithAetna&United
Healthcare(Thyroid)
ExpandingSalesForce
LaunchLungVer8calMVPdx
LaunchofThyGenXV2andTERTMarkerofAggressiveness
NewPancraGENstudies(GI)
Addi8onalLabServicesContracts
ExternalDriversSelec>veProductAcquisi>onsand
Alliances
StrategicPartnershipForBarreGEN
LeverageNewLabCorpContract
Why Invest in IDXG? Significant Financial
Progress
- Strong, growing revenue (39% YoY 2015 to 2016) and reimbursement
- NASDAQ listing fully compliant
- Eliminated all of our secured debt and liens and eliminated royalty & milestone obligations from 2014 purchase of RedPath Assets
- Demonstrated liquidity with our stock trading volume
- $21M cash raised in last 6 months
- ThyGenX V2 development underway
- Thyroid registry launched
- Completed development of Lung Vertical MVPdx
- Multi-Center Thyroid study launched
- Barrett’s CEP/Soft launch underway
- Multiple presentations at key Scientific meetings planned for 2017
- PancraGEN: 3 clinical utility studies underway
New Clinical and Product Development
- 26 Person Internal Sales Organization
- In-house billing, reimbursement and collections expertise
- Marketing and product launch expertise
- AETNA & United Health approvals
- All products covered by Medicare
- 250+ million lives covered for Thyroid test,71+ million lives covered for PancraGEN test
- Launched MVPdx Lung 3Q 2017
Growing Commercial Capabilities
ASIGNIFICANTPARTNERINGOPPORTUNITYFORBARREGEN
Thank You
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