FullYearResultsPresentationForthetwelvemonthsto31March2016
26May2016
DavidDarling,CEO
PacificEdge2016FullYearResultsPresentation
Uplift inCommercialRevenue
Growing customernumbers intheUnitedStatesandothertargetedmarkets
MilestoneAchievements inUnitedStates
Expanded US sales team
Signed Federal SupplySchedule AgreementwithVA
Kaiser PermanenteUserProgrammeprogressing well
GoodCommercial ProgressinOther Markets
NewCommercialPartnership inAustralia
FirstUser ProgrammestartedinSingapore
Inclusion inCDHBnewhaematuriaHealthPathwayand available toUrologistsandGP’s in CDHBregion
Launch of Third Product,Cxbladder Monitor
Launched inNZinlate2015
Progressive rollout intoothermarketsover 2016
02:FY16HIGHLIGHTSAnotherYearofCommercial ProgressandGrowthParticularly intheUS
PacificEdge2016FullYearResultsPresentation
03:OURSTRATEGYGrowthStrategyPrimarilyFocusedontheUSMarket
OUROFFERDeliveringinnovativesolutionsfortheearlydetectionandbettermanagement ofbladdercancer
CurrentfocusonbuildingsuiteofCxbladder diagnostictests,tohelpdetectandmanagebladdercancerOurtestsarenon-invasive,accurate,fast,easytouseandcosteffective
OURMARKETSPrimarymarketistheUS,oneoftheworld’slargesthealthcaremarketsPacificEdgetestsarealsosoldcommercially inAustraliaandNewZealand
Continuingtoinvestigatenewglobalmarketopportunities– identifiedopportunityinSouthEastAsia
INVESTINGFORGROWTHFourmainareasofinvestment- People,IntellectualProperty,MarketExpansionandProductDevelopment
PacificEdge2016FullYearResultsPresentation
04:FY16REVENUEUplift inProductSales
FY16NZ$(000)
FY15NZ$(000)
Change(%)
Operating Revenue 4,976 1,900 162%
Other revenue 2,218 2,232
Total Income 7,193 4,132 74%
Inthepasttwoyears,operatingrevenuehasgrownfrom$150,000to$4.98million.
Continuinggrowthinproductsales,particularlyinNorthAmerica.IncludeslicencefeesfromTolmar AustraliafollowingestablishmentofnewcommercialpartnershipinFebruary2016
Thirdyearoffundingfroma$4.5millionCallaghanInnovationGrant
LABORATORY THROUGHPUTIncludesUserProgrammesandcommercialtests
114%increaseintest
throughputcomparedtothepreviousyear
Sixmonth financial reporting period
162% increasein operatingrevenue
comparedtothepreviousyear
OPERATING REVENUE
PacificEdge2016FullYearResultsPresentation
05:FY16FINANCIALSNAPSHOTContinuing Investment intoFourStrategicAreas
PEOPLE• ExpansionoftheUSAsalesteamto18executives• Increasedthecommercial,marketingandproduct
developmentteamsinNewZealand
PRODUCTDEVELOPMENT• LaunchofCxbladder TriageintotheUSA• LaunchofCxbladderMonitorinNewZealandin
late-2015
MARKETEXPANSION• BuildingmomentumandgainingtractionintheUSA• NewcommercialpartnershipinAustralia• Increasinguptakefromhealthcareorganisations
andurologistsinNewZealand• InvestigationintoSouthEastAsia
INTELLECTUAL PROPERTY• Continuingtoapplyforandreceivepatentsfor
PacificEdge’sdiagnostictechnologies
FY16$NZ’000
FY15$NZ’000
TotalRevenueandIncome 7,193 4,132
TotalExpenses 22,870 16,607
Net LossBeforeTax (15,676) (12,475)
Income TaxExpense - -
NetLoss AfterTax (15,676) (12,475)
Foreign ExchangeTranslation 223 154
ComprehensiveLossAfterTax (15,453) (12,322)
PacificEdge2016FullYearResultsPresentation
06:FY16FINANCIALPOSITION– BALANCESHEETCapitaltheMainSourceofFundingForGrowth
Cashandcashequivalents$24.16millionasat31March2016
Debtfreewithfundingfromcapitalandtechnologygrantsfornewproductdevelopment,commercialisation,USArolloutandinvestigationintoSouthEastAsia
Successfulcapitalraisingwithatotalof$35.3millionraisedthroughafullyunderwrittenrightsoffercompletedinJuly2015
FundsarebeinginvestedintoexpandingthecommercialprogrammeintheUSA,launchofnewCxbladder products,progressionofSouthEastAsiaopportunityandsubsequentcommercialprogrammeinSouthEastAsia
FY16$NZ’000
FY15$NZ’000
Cash,CashEquivalentsandShortTermDeposits
24,160 7,819
Trade Receivables,InventoryandOtherCurrentAssets
6,933 3,452
Property, PlantandEquipment 990 1,118
IntangibleAssets 248 244
TotalAssets 32,331 12,633
Payables andAccruals 2,523 1,931
TotalLiabilities 2,523 1,931
Equity 29,807 10,703
PacificEdge2016FullYearResultsPresentation
07:PRIMARYFOCUSONUSHEALTHCAREMARKET
FY16OBJECTIVE
BuildInfrastructureforGrowth
ACHIEVED:Expandto18salesexecutivescovering19targetedmajormetropolitanregions
Completedrecruitmentof18specialised sales executives.
Newpersonnel arenowfullytrainedandmobilised
FocusedonbuildingrelationshipswithexistingandnewcustomersincludingidentifiedVAhealthcareclinicsineachsales area
PacificEdgeistargetingsales activityin19majormetropolitanregions,whichithasidentifiedascoveringthemajorityofitspotentialmarketintheUSA.
PacificEdge2016FullYearResultsPresentation
08:CAPTURETRANSFORMATIONALCUSTOMERS
FY16OBJECTIVE
CaptureTransformationalCustomers
ACHIEVED:CompletetheFederalSupplyScheduleprocesstogainaccesstotheVeteransAdministration(VA)
INPROGRESS:CentreforMedicaidandMedicareServices(CMS)processestoallowaccess tothesepatientgroupsandinitiatecommercialrelationship
VeteransAdministration(VA)
GainedregistrationontheFederalSupplySchedule
PacificEdgenowhastheabilitytomarketandsellitsCxbladderproductstotheVA’s cliniciansandhealthproviderswhoprovidecarefor8.8millionUSveterans andtheirfamilies
CentreforMedicaidandMedicareServices(CMS)
WorkingtofinalisetheprocesswiththeCMSinthenearfuture
ThiswillallowPacificEdgetoclaimreimbursement forCxbladdertests fortheelderlypeoplewhouseCxbladdertests andare coveredunderMedicare
PacificEdge2016FullYearResultsPresentation
09:USERPROGRAMMESIncrease inUserProgrammes,FutureFocusonTransition toCommercial Customer
FY16OBJECTIVE
EnhanceAwarenessandFosterStrongAdoption
ONGOING:ContinuetorolloutUserProgrammestotargetedurologistsandclinicalgroups,particularlyintheUSA
INPROGRESS:CompletetheKaiserPermanenteUserProgrammeandtransitionthisintocommercialsalesinthefollowingyear
UserProgrammes:These areakeycomponentoftheadoptionofCxbladdertestsbyurologists
ContinuedtobuildthenumberofUserProgrammeswithafocusonLargeUrologyGroups(LUGs)whichhavefiveormoreurologistsandcommunitypracticeswithonetofoururologists
Increase inUser Programmesinthesecondhalfas theexpandedsales team reachedmoretargeturologists
KaiserPermanente
InitiatedlargescaleUserProgrammewithKaiser PermanenteinSouthernCaliforniainlateJune2015,torecruit2,000patients
Recruitmentnowcompletedafter introductionofanewelectronicrecruitingplatforminlate-2015
WenowexpecttheUser Programmetobecompletedin2016calendaryear.Followingthis,wewillbeworkingtotransitionKaiserPermanente intoalargescalecommercialcustomer
PacificEdge2016FullYearResultsPresentation
10:OTHERMARKETSGoodProgressinNewZealand,AustraliaandSouth EastAsia
FY16OBJECTIVE
GrowOurInternationalPresence
ACHIEVED:FinalisebusinesscaseforentryintotheSEAmarketandlooktoestablishoperationsinSingapore
ONGOING:Continuetoidentifynewmarketopportunitiesandexpandourinternationalpresence
SouthEast Asia:Entered intoaUser ProgrammeStudywithaleadinghospitalinSingaporeearlierinthefirsthalfyeartogenerate dataspecifictoSingaporeandtoenablephysicianstouse CxbladderDetectintheirclinicalsetting
Continuingdiscussionsandworkingthroughapprovalprocesswithseveral otherleadinghospitalstoallowthemtoevaluate Cxbladderproductsintheirownclinicalsettings
Inprocess ofestablishingcommercialbaseinSingaporewhichwillprovideahubforfurtherinvestigationintoSEA
Twodistinctmarketopportunitiesbeingevaluated:
• Patientsrequiringtestingandmanagement forbladdercancer• Rapidlygrowingnumberofmedicaltouristswhocometotheregionforregularwellness
andmedicalcheckups.
Australia:Established newcommercialpartnershipwithTolmar AustraliainFebruary2016
NewZealand:ContinuetoworkcloselywithurologistsinNew Zealand
Signedagreement withCanterburyDHBtoprovideCxbladder technologyforprimarycarereferralintheevaluationofhaematuria (bloodintheurine).
PacificEdge2016FullYearResultsPresentation
11:DELIVERA‘ONESTOPSHOP’OFCXBLADDERPRODUCTS
FY16OBJECTIVE
INPROGRESS:Delivera‘onestopshop’ofCxbladder Products
CxbladderDetectIn-Market 2013/14
CxbladderTriageNZLaunchDec2014USRollout2015
CxbladderMonitorNZLaunchDec2015USRolloutin2016
CxbladderPredictExpected Launch2016
Designed forusebyurologists,forpatientswhohavebeen referred forafullworkup
Tobeused bycliniciansandphysiciansresponsiblefortheprimarydetectionofbladdercanceras afrontlinetoolintheearly evaluationofhaematuria(bloodintheurine)
Helpsegregate lowgrade tumoursfromhighgradeandlatestagetumours
Helpphysiciansmonitorbladdercancerinpatients
PacificEdge2016FullYearResultsPresentation
12:LAUNCHPRODUCTSINTOMARKET
FY16OBJECTIVE
ACHIEVED:LaunchCxbladderTriageintheUSA
INPROGRESS:CommercialisationofCxbladderMonitorandPredict,withinitiallaunchinNewZealandandafastfollowupintheUSA
Cxbladder Triageavailable inmarketinNewZealand fromDecember 2014;LaunchintotheUScommencedinJuly2015
AnumberofleadingurologistsarecurrentlytriallingCxbladderTriage intheirclinicalsettings
CxbladderTriage performance publishedinpeerreviewed sciencepaper intheprestigiousinternationalmedicaljournal,BMCUrology,inApril2015
Received CLIAapprovalforDunedinlaboratoryinAugust 2015.WorkingthroughtheprocesstoachieveCLIAapprovalforUSlaboratoryin2016.
Cxbladder MonitorsuccessfullylaunchedinNewZealandDecember 2015;rolloutinNZandAustraliaplannedin2016
Positiveclinicalstudyresultspresented byDrYair Lotan atAUAConferenceinSanDiegoinMay 2016
OfficialUSlaunchtimedtocoincidewithpeer reviewedscientificpublicationofthestudyinmid-2016
Cxbladder PredictplannedtolaunchinNewZealand laterin2016
PacificEdge2016FullYearResultsPresentation
13:PROTECTOURINTELLCTUALPROPERTY
PATENTSACCEPTED/GRANTEDFY16FY16OBJECTIVE
ONGOING:ProtectPacificEdge’sintellectualproperty,overarangeofdiagnostictechnologies,inmarketsaroundtheworld
Title Country
GastricCancer I China
Gastric CancerII Europe
BladderCancerMarkers Australia,Korea, Taiwan
Gene Expression Ratios China,Korea
Gastrointestinal Cancer – Prognosis Japan
Colorectal Cancer– Prognosis Korea
PacificEdge2016FullYearResultsPresentation
14:ENGAGEWITHTHEPEOPLEWHOMATTER
FY16OBJECTIVE
ACHIEVED:Launchonlinepatientcommunityforbladdercancerpatients,bladdercancer.me
PacificEdgeistheleadingsponsorofbladdercancer.me,anonlinereferral sitetoenable patientstoseek themostappropriatehealthcare providersandsolutions,includinginformationonthesuiteofCxbladder products
Sitewentliveinlate-December 2015.OfficialmarketinglaunchofthesiteinMay2015tocoincidewithBladderCancer Awareness MonthintheUS
Providesonline,relevantresources forbladdercancerpatients:• Peersupport• Access toappropriatehealthcareproviders• Symptomtracking
PacificEdge2016FullYearResultsPresentation
15:STRATEGICOPPORTUNITIESFORGROWTH
• Development ofsuiteofCxbladderproducts• IPoverothercancerexpressionswithopportunitytodevelop
specificdiagnostictestsMoreProducts
• Organicgrowthinexistingmarkets– NZ,Australia,USA• Geographicalexpansionintonewmarkets– SouthEastAsia, Europe,
restofworld
• Directtoconsumer,ecommerce,corporatecustomers,integratedhealthcareproviders,nationalhealthcareproviders
• Healthcare andclinicalorganisations• Corporates• Patients
MoreCustomers
MoreMarkets
MoreSalesChannels
TargetingHighGrowthOverTheMedium TermbyCreatingMoreProducts andBuildingSales inanIncreasing Number ofMarkets
PacificEdge2016FullYearResultsPresentation
16:LOOKINGFORWARD:GROWTHEBUSINESSPRIORITIESFORFY17
MARKETS
• US:Remainstheprimaryfocusforgrowth
• Australia:WorkwithTolmar Australiatobuildawareness andincrease sales ofCxbladder testsinAustralia
• SEA: Establishabase inSingaporeforfurtherinvestigationintoSouthEastAsia, continuetosupportcurrentUserProgrammeinSingaporeandinitiatenewUser Programmeswithtargeted healthcareproviders
• NZ:ContinuetoworkcloselywithhealthcareprovidersandurologistsinNew Zealandtoencourage uptakeofCxbladder
PRODUCTS
• RolloutofCxbladder MonitorintotheUnitedStatesandAustralia
• LaunchCxbladder PredictinNew Zealand
SALESCHANNELS
• USsales teamtocontinuetargetinglargeUrologypracticesandintegratedhealthcareprovidersaswellastargeted, largeVeteransAdministrationhealthcareproviders
• Identifyandinvestigatenewsales channels
• Increase onlinemarketingandproductawareness, includingongoingsupportforpatientcommunity,bladdercancer.me
CUSTOMERS
• CompleteKaiserPermanenteUser Programmeandprogress tocommercialrelationship
• Continuetoprogress discussionswithCentreforMedicare andMedicaidServices
• ContinuetoinitiatenewUser Programmes andtransitionearlyadoptersintocommercialcustomers
PacificEdge2016FullYearResultsPresentation
17:BOARDANDMANAGEMENTProvidingTheExperienceandCapabilitytoDeliveronPacificEdge’sGrowthStrategy
Theopportunity forourCxbladder technologyissignificantandweanticipateanotheryearofgrowingreturns asweworktowards ourgoalofprovidinga‘onestopshop’ofhigh
performanceCxbladder products forurologists.
MANAGEMENTTEAM
Experiencedandknowledgeableinthefollowingareas:
Developmentandinternationalcommercialisationofbiomedicalandbiotechbusinesses
Leadership
Newproductdevelopment
Researchanddevelopment
Commercialexperienceincludingin-marketknowledge.
GOVERNANCE
BoardofDirectors
Experienceingovernance,finance,cancerresearch,biotechnologyandlifesciences, investmentandbusinessadvisory.Twonewdirectorsappointedinpasttwoyears.
SubsidiaryBoardDirectors
In-countrycommercialexperienceandscientificexpertise.
ScientificandClinicalAdvisoryBoards
Expertadviceonglobalclinicalneedsandproductapplications;andscientificprogressandclinicalopportunities.
PacificEdge2016FullYearResultsPresentation
QUESTIONANDANSWER
PacificEdge2016FullYearResultsPresentation
www.pacificedge.co.nzwww.cxbladder.comwww.pacificedgedx.com
DavidDarlingChief ExecutiveOfficerPacific EdgeLimitedTel:+6434795802 Mobile: +6421797981Email:[email protected]
PacificEdge2016FullYearResultsPresentation
DISCLAIMER
InformationThe information in thispresentation isanoverview and does notcontain allinformation necessary tomake an investment decision. Itisintended to constitute asummary ofcertain information relating totheperformance of Pacific EdgeLimited .The information inthis presentation isof ageneral natureand does not purport tobe complete. Thispresentation should beread inconjunction withPacific Edge's otherperiodic and continuous disclosure announcements, which are availableatnzx.com.Not financial product adviceThis presentation isfor information purposes onlyand isnot financial orinvestment adviceor arecommendation toacquire Pacific Edgesecurities, and has been preparedwithouttakingintoaccount theobjectives, financial situation orneeds of individuals. Pacific Edge, itsdirectors andemployees do not giveormake anyrecommendation or opinion inrelation toacquiring or disposing of shares. Inmaking an investment decision, investorsmust relyon theirown examination of Pacific Edge, including themerits and risksinvolved.Investors should consult withtheirown legal,tax, business and/or financial advisors inconnection withanyacquisition ofsecurities.Future performanceThis presentation contains certain'forward-looking statements', for example statements concerning thedevelopment andcommercialisation of new products, regulatoryapprovals, customer adoption andresults of future clinical studies. Forward-looking statements can generally beidentified bythe useof forward-looking words such as, 'expect','anticipate', 'likely','intend', 'could', 'may', 'predict', 'plan', 'propose', 'will','believe','forecast', 'estimate', 'target','outlook', 'guidance' andother similar expressions. The forward-looking statements contained inthispresentation arenot guarantees or predictions of future performance and involveknown and unknown risksand uncertainties and otherfactors, many ofwhich arebeyond thecontrol of Pacific Edgeandmay involvesignificant elements of subjective judgement and assumptions astofuture eventswhich mayormaynot becorrect. There can beno assurance thatactual outcomes willnotmateriallydiffer from these forward-looking statements. Anumber of important factors could causeactual results orperformance to differmateriallyfrom theforward-looking statements. The forward-looking statements arebased on information availableto Pacific Edgeas atthedate of thispresentation. Except asrequired bylaworregulation (including theNZXMainBoard Listing Rules), Pacific Edge undertakes noobligation toprovide anyadditionalorupdated information whether asaresultof new information, future events orresults orotherwise. No representationTothemaximum extent permitted bylaw,Pacific Edgeand itsadvisers, affiliates, relatedbodies corporate, directors, officers, partners, employees and agentsmake norepresentation orwarranty,express or implied, asto thecurrency, accuracy, reliabilityorcompleteness of information in this presentation.
This presentation should be viewed inconjunction with Pacific Edge’s Financial Statements for the12months to31March 2016 and theaccompanying media releasewhichwasreleased tothemarketon 26May2016.
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