full year results presentation for the twelve months to 31 ......full year results presentation for...
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FullYearResultsPresentationForthetwelvemonthsto31March2017
24May2017
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PacificEdge2017FullYearResultsPresentation
JointanalysisofKaiserPermanentestudycompletedwithpositiveandcompellingresults
OfficialUSlaunchofCxbladderMonitor
NZLaunchCxbladderResolve
Successful$8mshareplacement
NamedinTIN100TopTenHotEmergingCompanies
FY17MILESTONESSignificantProgressAchieved
Officiallaunchofbladdercancer.mesite
Cxbladder MonitorpresentationatAUA
MTANZAwardwinner
InsurancecoveragewithSovereign
Insurancecoveragewithnib
ApprovedprovidertoTRICARE
AddedtostandardofcareforWaitemata DHB
APRIL MAY JUNE JULY AUG SEPT OCT NOV DEC JAN FEB MAR
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PacificEdge2017FullYearResultsPresentation
Significantprogressachievedwithtransformationallargescalecustomers
IncontractwithVA
IncontractwithTRICARE
CompletedKaiserPermanenteUserProgrammeandnowincommercialdiscussions
WellprogressedwithCMSregulatoryprocess
Increasingadoptionbyhealthcareprovidersandinsurers
InsurancecoveragebynibandbySovereigninNewZealand
AddedtoStandardofCareforWaitemata DHB
AddedtoStandardofCareforCanterburyDHB
MultipleclinicalstudiesandpapersvalidatingthesuperiorperformanceofCxbladder
Presentations/publications:AmericanUrologicalAssociation2016Conference
AmericanJournalof Urology
UrologicalOncologyAdvancesinTherapy
UrologyspecificmediaGenomeWeb
UrologyTimes
Expanded suiteofCxbladdertests
OfficiallaunchofCxbladderMonitorintheUSinDecember2016
Launchoffourthproduct,CxbladderResolve,inNewZealandinDecember2016
FY17HIGHLIGHTSSignificantcommercialprogressbeingmade;ContinuedsalesgrowthexpectedinFY18
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PacificEdge2017FullYearResultsPresentation
FY17REVENUE62%UpliftinProductSales
FY17NZ$(000)
FY16NZ$(000)
Change(%)
Operating Revenue 8,062 4,976 62%
Other revenue 1,473 2,217
Total Revenue 9,535 7,193 33%
Positivegrowthinproductsalesfromnewandexistingcustomers,particularlyinNorthAmerica.
FY17excludesanyrevenuefromtransformationalcustomers.
OtherrevenueincludesfundingfromCallaghanInnovationGrant,withanadditional$3mgrantreceivedinMarch2017,tobespreadovertwoyears.
OPERATINGREVENUE
LABORATORYTHROUGHPUTIncludesUserProgrammesandcommercialtests
35%increaseintest
throughputcomparedtothepreviousyear
Sixmonthfinancialreportingperiod
62% increasein operatingrevenue
comparedtothepreviousyear
0
2000
4000
6000
8000
10000
12000
FY14 FY15 FY16 FY171H 2H
0
2
4
6
8
10
FY15 FY16 FY17
NZ$Million
IHOpRevenue 2HOpRevenue TotalRevenue
Inthepastfouryears,operatingrevenuehasgrownfrom$150,000to$8.1million
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PacificEdge2017FullYearResultsPresentation
FY16:FY17REVENUEBRIDGE
FY16
OperatingRevenueGrowth
Grantfunding
FX,Interest,Other
FY17
REVENUEGROWTH
Positivegrowthinproductsales:Nocontributionyetfromnewlargescalecustomers– VAandTRICARE
FY17salesrestrainedby:• Timingofcommercialisationofscalecustomers• TimingoflaunchofnewproductsintheUS• PoliticaluncertaintyintheUSwhichnegatively
impactedonthewiderhealthcaresectorintheUSinthesecondhalfoftheyear.
ChangesinCallaghanInnovationGrowthGrantschememeansthatinternationalinvestmentinR&Disnolongerclaimable
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+62%
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PacificEdge2017FullYearResultsPresentation
FY17INVESTMENTINTOGROWTH
OPERATINGEXPENSES
Continuedinvestmentintofourstrategicareas:• People– expandedsalesteamfrom12to18salesexecutives• Products– developmentandlaunchofCxbladderResolve• Marketexpansion– investmentintoSouthEastAsiaandUS• IntellectualProperty
Expensesincludenon-cash,non-recurringexpenseof$2.9minrelationtothewindupoftheEmployeeIncentiveScheme
Conservativeapproachtakentobaddebtprovisioning
Operatingrevenueoutgrowingexpenses:OperatingRevenue+62%;OperatingExpenses+6%Note:OperatingExpensescomparedonalike-for-likebasis
Overall,PacificEdgereporteda$21.0millionlossfortheyear,inlinewithgrowthstrategyandmanagementexpectations.
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FY17$NZ’000
FY16$NZ’000
%Change
TOTALREVENUE 9,535 7,193 33%
Laboratory Expenses 996 1,047
Research 4,908 4,442
SalesandMarketing 1,923 1,021
Other 16,517 16,358
TotalRecurringOperatingExpenditure
24,342 22,870 6%
BadandDoubtfulDebtsExpenditure
3,248 -
Wind upofEmployeeIncentiveScheme(non-cash)
2,925 -
NET(LOSS)BEFORETAX (21,048) (15,453) 36%
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PacificEdge2017FullYearResultsPresentation
FY17CASHFLOW
NETOPERATINGCASHFLOW
Netoperatingcashflowatasimilarleveltothepreviousyear
116%increaseinreceiptsfromcustomersandgrantincomecomparedtoFY17,offsettingthehigherFY17expenses
NETOPERATINGCASHFLOWS FY17$NZ’000
FY16$NZ’000
Receipts fromcustomersandgrantproviders 7,864 3,648
Interestreceived 732 319
Paymentstosuppliersand employees 26,458 20,908
NetGSTchange (25) 12
NET CASHFLOWSFROMOPERATINGACTIVITIES
(17,837) (16,952)
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PacificEdge2017FullYearResultsPresentation
FY17FINANCIALPOSITION– BALANCESHEETDebtfree– ShareholderCapitaltheMainSourceofFundingForGrowth
Cashandcashequivalents$14.6millionasat31March2017
Debtfreewithfundingfromsalesrevenue,shareholdercapitalandtechnologygrantsfornewproductdevelopment,commercialisationandinvestigationintoSouthEastAsia
Successful$8.75millionshareplacementtoinstitutionalandotherinvestorscompletedinFebruary2017
Fundsarebeinginvestedintocommercialgrowthasthecompanyworkstowardsattainingacashflowpositiveposition.
FY17$NZ’000
FY16$NZ’000
Cash,CashEquivalentsandShortTermDeposits
14,564 24,160
Trade Receivables,InventoryandOtherCurrentAssets
7,833 6,933
Property, PlantandEquipment 837 990
IntangibleAssets 329 248
TotalAssets 23,563 32,331
Payables andAccruals 2,734 2,523
TotalLiabilities 2,734 2,523
Equity 20,829 29,807
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PacificEdge2017FullYearResultsPresentation
IncidencerankingfortheUSA
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PacificEdge2017FullYearResultsPresentation
CXBLADDERNOWDOMINATESTHECLINICALPATHWAY
• Delivering innovative solutions for the early detection and bettermanagement of bladder cancer
• Four products serving multiple clinical needs, across thehaematuria and bladder cancer clinical pathways
• Provides a huge opportunity and significant competitive advantagefor Pacific Edge
• Cxbladder leading to a step change in the clinical pathways forhaematuria and bladder cancer
• Benefits: Accurate, Non-invasive, Simple to Use, Cost Effective
• PrimarymarketistheUS,theworld’slargesthealthcaremarket.
• Fourmainareasofinvestment- People,IntellectualProperty,MarketExpansionandProductDevelopment
Pacific Edge is the only company in the world to offer a suite of proprietary molecular diagnostic tests forbladder cancer, from assessment and detection to management and monitoring for recurrence of the disease
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PacificEdge2017FullYearResultsPresentation Slide11
TARGETMARKETS
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PacificEdge2017FullYearResultsPresentation
MARKETSGrowingadoptionofCxbladder
Transformationalclients(UnitedStates)
National ProviderNetworks(UnitedStates)
PrivateInsuranceProviders(NewZealand)
Adoption byDistrictHealthBoards(NewZealand)
Veterans Administration– Incontract
TRICARE– Incontract
KaiserPermanente– Incommercialdiscussions
CMS– Wellprogressedinregulatoryprocess
Stratose
FedMed
America’sChoiceProviderNetwork
MultiPlan
SovereignInsurance
Nibhealthinsurance
Bay ofPlentyandLakes
Canterbury
Waitemata
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PacificEdge2017FullYearResultsPresentation
MARKETSUSRemainsthePrimaryFocus
COMPLETED √ 18salesexecutivesfocusedon19targetedsalesregions
COMPLETED √ Identified VeteransAdministration(VA),TRICARE,KaiserPermanenteandCentresforMedicareandMedicaidastransformationallargescalecustomers
COMPLETED √ Incontract andagreedpricingwithVAandTRICARE
InProgress Incommercial discussionswithKaiserPermanente;WellprogressedinCMSregulatoryprocess
Ongoing LargeUrologyGrouppractices- Keytargetforscale sales,nowmovingatpace,salesarestartingtomeet companyexpectations
Ongoing PrimaryfocusonestablishingnewUserProgrammeswithlargeinstitutionalcustomersaswebuildmomentum
Ongoing TransitioningexistingUserProgrammestocommercialcustomers
UnitedStates:Theworld’slargesthealthcaremarketOver11,000urologistsandmillionsofpotentialclinicalopportunitiesforuseofCxbladderproducts
Slide13
FY17OBJECTIVESANDPROGRESS:USRemainsthePrimaryFocus
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PacificEdge2017FullYearResultsPresentation
COMPLETED√ SignedFederalSupplySchedule Agreement(Feb2016)
COMPLETED√ Negotiatedcontractpricefortests(2016)
COMPLETED√ Identified leadingVAcentreswithvolumehaematuria
COMPLETED√ CxbladdertestaddedtotheVAscheduleapproved forsaletoveterans:• Cxbladderhasacodewhich ensureseaseofuseand
speedyrecoveryofrevenue• Cxbladderhasacontracted pricewiththeF.S.Sforthe
VA.Sitesmaynegotiateto obtainabetterrate(Volume).
InProgress Targeting fivelargeVAclinics.SeveraloftheseclinicsexpectedtoincorporateCxbladderintotheirclinicalpracticeinthenearfuture.AnticipateUserProgrammes forthelarger keysitesasperotherlargenon-VA customers
VETERANSADMINISTRATION(VA)OneofPacificEdge’sKeyCustomers
VETERANSADMINISTRATION
• Federalfundedhealthcareforveteransandtheirfamilies
• BeingincontractprovidestheabilitytomarketandsellCxbladderproductstotheVA’scliniciansandhealthproviders
• Approximately20millionpeopleundercoverincludingfamilymembers
• Networkofitsownclinics,hospitalsanddedicatedstaff
Slide14
FY17OBJECTIVESANDPROGRESS:ContinuetotargetselectedVAsites
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PacificEdge2017FullYearResultsPresentation
TRICAREOneofPacificEdge’sKeyCustomers
TRICARE
• Healthcareprogramme forUSuniformedservicemembersandtheirfamiliesaroundtheworld
• ManagedbytheDefenseHealthAgency
• 9.4millionbeneficiarieswith70.5millionoutpatientvisitsin2015
• 55Militaryhospitals
• 373militarymedicalcentres
COMPLETED√ Approved asaprovider(October2016)
COMPLETED√ Negotiatedcontractpricefortests(October2016)
InProgress ThePacificEdgeUSsalesteamareleveragingexistingrelationshipswithhighvolumesitesintargeted areas
AnticipateUserProgrammes for thelarger keysitesasperotherlargecustomers
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PacificEdge2017FullYearResultsPresentation
KAISERPERMANENTEPotentiallyTransformationalForTheCompany
KAISERPERMANENTE
• Anintegratedmanagedcareprovider,headquarteredinCalifornia
• Fullyintegratedhealthcareincludinginsurancecoverageofitspatients
• Oneofthenation’slargestnot-for-profithealthplans,servingmorethan10.6millionmembers(approx.twicethesizeofNewZealand)
• Morethan18,000physiciansemployedacross38hospitalsandmorethan600medicalofficesandotherfacilities
COMPLETED√ Completionof largescaleUserProgrammeinfirsthalfFY17
COMPLETED √ Jointanalysisofdatacompletedwithpositiveandcompellingfindings
In Progress Study findingstobesubmittedforscientificandclinicalpublication
In Progress InfinaldiscussionswithKaiserPermanenteregardingwhereintheirclinicalpathwaytheywilldeployCxbladder
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FY17OBJECTIVESANDPROGRESS:CompleteKaiserPermanenteUserProgrammeandprogresstocommercialrelationship
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PacificEdge2017FullYearResultsPresentation
CENTERSFORMEDICAREANDMEDICAID/OTHERCUSTOMERS
CENTERSFORMEDICAREANDMEDICAID
• USfederalagencywhichadministersMedicareandMedicaid
• Medicareisnationalsocialinsuranceprogramprovidinghealthinsuranceforover46millionAmericansaged65andolder
• MedicaidissocialhealthcareprogramforlowincomeAmericanfamiliesandindividuals
InProgress RegulatoryprocesstogainaLocalCoverageDecisionwiththeCMSiswellprogressed
Ongoing USsalesteamcontinuingtotargetindividualurologistsandlargeurologypracticestoinitiatenewUser Programmes,andtransitionearlyadoptersintocommercialcustomers.Thefocuswillbeonlargepracticesinacademiccentres
Workwithacademic centresand hospitalstogainacceptanceofCxbladderintotheircarepathways
Slide17
FY17OBJECTIVESANDPROGRESS:ProgressdiscussionswithCMS
ContinuetoinitiatenewUserProgrammeswithkeycustomers
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PacificEdge2017FullYearResultsPresentation
OTHERMARKETSNewZealand,Australia,SouthEastAsia
AUSTRALIA WorkwithTolmar AustraliatobuildawarenessandincreasesalesofCxbladdertestsinAustralia• Tolmar Australia’sninededicatedurologysalesexecutivesleveragingtheirexistingnetworks;
targetinglargehospitalsaswellasindividualurologists• ThreeproductsnowavailableinAustralia
SOUTHEASTASIA EstablishabaseinSingaporeforfurtherinvestigationintoSouthEastAsia,continuetosupportcurrentUserProgrammeinSingaporeandinitiatenewUserProgrammeswithtargetedhealthcareproviders• CommercialbasenowestablishedinSingaporeincludingdistributionandlogisticsprocesstoallow
testanalysisinNewZealand• WorkingonsigningupnewUserProgrammeswithlargehospitals.SecondUserProgramme
commenced,withSingapore’slargesthospital
NEWZEALAND ContinuetoworkcloselywithhealthcareprovidersandurologistsinNewZealandtoencourageuptakeofCxbladder• AgreementswithseveralDistrictHealthBoardstoincludeCxbladderinclinicalpathway• Cxbladderundercoverbytwohealthcareinsuranceproviders
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PacificEdge2017FullYearResultsPresentation
CXBLADDERDETECTIn-Market2013/14
CXBLADDERTRIAGEIn-Market2015/2016
CXBLADDERMONITORNZLaunchDec2015
OfficialUSLaunchDec2016
CXBLADDERRESOLVENZLaunchDec2016USARollout2018
PRODUCTSOurProductsNowSpanTheEntireClinicalPathway- AWorldFirst
FY17OBJECTIVESANDPROGRESS
RolloutofCxbladderMonitorintotheUnitedStatesandAustralia• Australiarolloutcompleted• FullUSAlaunchinDecember2016tocoincidewith
publicationofscientificpaper
LaunchCxbladderResolveinNewZealand• LaunchedinNewZealandinDecember2016
CxbladderincludedinStandardofCareandguidelines• IncludedinAUAguidelinesasanalternativetest• AddedtoStandardofCareforpubliclyfundedCanterbury
DistrictHealthBoard(CDHB)andWaitemata DHB
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PacificEdge2017FullYearResultsPresentation
GROWINGCLINICALEVIDENCEINSUPPORTOFCXBLADDER
Slide20
84%
97%
13%
23%
20% 29
%
4%
14%
0%
20%
40%
60%
80%
100%
Low Grade High Grade
Sensitivity by Tumour Grade
Cxbladder Monitor Urine Cytology
NMP22 ELISA NMP22 BladderChek
93% 98
%
33%
92%
0%
20%
40%
60%
80%
100%
Sensitivity NPV
Sensitivity of Cxbladder Monitor vs UroVysion FISH
Cxbladder Monitor UroVysion FISH
SUPERIORSENSITIVITYOFCXBLADDERMONITORINCLINICALSTUDYLotanetal:Clinicalcomparisonofnon-invasiveurinetestforrulingoutrecurrenturothelialcarcinoma.UrologicOncology(2017)
89% 97
%
100%
16%
31%
26%
21%
41%
32%
5%
31%
11%
0%
20%
40%
60%
80%
100%
Ta Tis ≥T1
Sensitivity by Tumour Stage
SUPERIORPERFORMANCEOFCXBLADDERMONITORINRULINGOUTRECURRENCEOFBLADDERCANCER“PerformanceCharacteristicsofaMultigeneUrineBiomarkerTestforMonitoringforRecurrentUrothelialCarcinomainaMulticenter Study”
93%Sensitivity
97%Negative PredictiveValue
COMPELLINGCHANGESINCLINICALDECISIONSWITHUSEOFCXBLADDERTRIAGEANDCXBLADDERDETECT396clinicianbypatientinteractionstotalling792separateclinicaldecisions
• Allurologistschangedtheirclinicaldecisionmaking• 25%reductionintotalnumberofdiagnosticproceduresrequired• 31%reductionininvasivetests
CXBLADDERMONITORSIGNIFICANTLYOUTPERFORMEDALLCOMPAREDFDAAPPROVEDURINETESTSFORBLADDERCANCER“ClinicalComparisonofNon-invasiveUrineTestsforRulingOutRecurrentUrothelialCarcinoma”
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PacificEdge2017FullYearResultsPresentation
SALESCHANNELSBuildAwareness,EncourageAdoption,TransitionToCommercialCustomer
FY17OBJECTIVESANDPROGRESS
In Progress ContinuetoinitiatenewUserProgrammesandtransitionearlyadoptersintocommercialcustomers
• NowstartingtoseetractionasUserProgrammestransitiontocommercialcustomers
InProgress Identifyandinvestigatenewsaleschannels
• Continuetoidentifynewsaleschannels• Enhanced e-commerceplatform
InProgress Increaseonlinemarketingandproductawareness,includingongoingsupportforpatientcommunity,bladdercancer.me
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PacificEdge2017FullYearResultsPresentation
LOOKINGFORWARDPrioritiesForFY18
MARKETS
• UnitedStatesremainstheprimaryfocus• NewZealand:ContinuetoencourageuptakebyDHBs• Australia:ConversionofUserProgrammeswithearly
adopters• Singapore:GrowUserProgrammebasewithnewurology
practicesandhospitals
PRODUCTS
• RolloutofCxbladderResolveinAustralia,withsoftlaunchinUSbyyear-end
• LeveragethecombinedpoweroftheCxbladdersuiteacrossthehaematuriaandurologypathwaysaffectingtheStandardofCare
CUSTOMERS
• BringKaiserPermanenteonboardascommercialcustomer• BuildcommercialrelationshipswithtargetedlargescaleVA
facilitiesandurologypracticesthatservicetheactivemilitary• InitiateUserProgrammeswithtargetedVeterans
Administrationsites• CompletetheregulatoryprocessforCenters forMedicare
andMedicaidServices• Transitionearlyadoptersintocommercialcustomers
SALESCHANNELS
• ContinuetoinitiatenewUserProgrammes• Increasedmarketinginvestment,particularlyintodigital
media• Targetinginstitutionalandlargepracticeacademicsitesinthe
US
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PacificEdge2017FullYearResultsPresentation
QUESTIONANDANSWER
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PacificEdge2017FullYearResultsPresentation
www.pacificedge.co.nzwww.cxbladder.comwww.pacificedgedx.com
DavidDarlingChiefExecutiveOfficerPacificEdgeLimitedTel:+6434795802Mobile:+6421797981Email:[email protected]
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PacificEdge2017FullYearResultsPresentation
DISCLAIMER
InformationTheinformationinthispresentationisanoverviewanddoesnotcontainallinformationnecessarytomakeaninvestmentdecision.ItisintendedtoconstituteasummaryofcertaininformationrelatingtotheperformanceofPacificEdgeLimited.Theinformationinthispresentationisofageneralnatureanddoesnotpurporttobecomplete.ThispresentationshouldbereadinconjunctionwithPacificEdge'sotherperiodicandcontinuousdisclosureannouncements,whichare availableatnzx.com.NotfinancialproductadviceThispresentationisforinformationpurposesonlyandisnotfinancialorinvestmentadviceorarecommendationtoacquirePacificEdgesecurities,andhasbeenpreparedwithouttakingintoaccounttheobjectives,financialsituationorneedsofindividuals.PacificEdge,itsdirectorsandemployeesdo notgiveormakeanyrecommendationoropinioninrelationtoacquiringordisposingofshares.Inmakinganinvestmentdecision,investorsmustrelyontheirownexaminationofPacificEdge,includingthemeritsandrisksinvolved.Investorsshouldconsultwiththeirownlegal,tax,businessand/orfinancialadvisorsinconnectionwithanyacquisitionofsecurities.FutureperformanceThispresentationcontainscertain'forward-lookingstatements',forexamplestatementsconcerningthedevelopmentandcommercialisationofnewproducts,regulatoryapprovals,customeradoptionandresultsoffutureclinicalstudies.Forward-lookingstatementscangenerallybeidentifiedbytheuseofforward-lookingwordssuchas,'expect','anticipate','likely','intend','could','may','predict','plan','propose','will','believe','forecast','estimate','target','outlook','guidance'andothersimilarexpressions.Theforward-lookingstatementscontainedinthispresentationarenotguaranteesorpredictionsoffutureperformanceandinvolveknownandunknownrisksanduncertaintiesandotherfactors,manyofwhicharebeyondthecontrolofPacificEdgeandmayinvolvesignificantelementsofsubjectivejudgementandassumptionsastofutureeventswhichmayormaynotbecorrect.Therecanbenoassurancethatactualoutcomeswillnotmateriallydifferfromtheseforward-lookingstatements.Anumberofimportantfactorscouldcauseactualresultsorperformancetodiffermateriallyfromtheforward-lookingstatements.Theforward-lookingstatementsarebasedoninformationavailabletoPacificEdgeasatthedateofthispresentation.Exceptasrequiredbylaworregulation(includingtheNZXMainBoardListingRules),Pacific Edgeundertakesnoobligationtoprovideanyadditionalorupdatedinformationwhetherasaresultofnewinformation,futureeventsorresultsorotherwise.NorepresentationTothemaximumextentpermittedbylaw,PacificEdgeanditsadvisers,affiliates,relatedbodiescorporate,directors,officers,partners,employeesandagentsmakenorepresentationorwarranty,expressorimplied,astothecurrency,accuracy,reliabilityorcompletenessofinformationinthis presentation.
ThispresentationshouldbeviewedinconjunctionwithPacificEdge’sFinancialStatementsforthe12monthsto31March2017 andtheaccompanyingmediareleasewhichwasreleasedtothemarketon24May2017
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