interim report january–march 2016 xvivo …...apr 26, 2016 · the company’s products xps™...

XVIVO Perfusion is a medical technology company which develops and markets solutions and systems for assessing the usability of organs, enabling the treatment of organs and maintaining organs in good condition outside the body pending transplantation. Currently, the company’s product Perfadex® has a market share of more than 90 percent in the traditional preservation of lungs for transplantation. The company’s products XPS™ and STEEN Solution™ for warm perfusion have regulatory approval in all major markets, and are the only products today to have received regulatory approval from the FDA for warm perfusion of lungs. XVIVO Perfusion employs around 25 people at its headquarters in Gothenburg, Sweden, and its office for North & South America in Denver, USA. The XVIVO share is listed on NASDAQ First North Premier and has the ticker symbol XVIVO. The Certified Adviser is Redeye, www.redeye.se.

INTERIM REPORT JANUARY–MARCH 2016

XVIVO PERFUSION AB (PUBL)

2 Interim Report January – March 2016 XVIVO Perfusion AB, org.nr. 556561-0424

17% GROWTH (EXCL. DURABLE GOODS) AND 22% EBITDA MARGIN*

FIRST QUARTER 2016 (JAN – MAR)•Netsalesofnon-Durablegoods**inthequarteramountedtoSEK29.1(25.1)million,correspondingtoanincreaseof16percentinSEK.Salesofnon-Durablegoodsincreasedby17percentinlocalcurrency.NetsalesinthequarteramountedtoSEK33.5(31.8)million,correspond-ing to an increase of 5 percent.

•Operatingincomebeforedepreciationandamortization(EBITDA)excludingone-timeexpensesamountedtoSEK7.3(4.5)million,correspondingtoanEBITDAmarginof22percent.One-timeexpensesofSEK2.4millionrelatedtotheNasdaqStockholmmainmarketlistingandthepublicofferforVivolinehavebeenchargedagainstthequarter.Operatingincomebeforedepreciationandamortization(EBITDA)amountedtoSEK4.9(2.9)million,correspondingtoanEBITDAmarginof15percent.

•NetincomeamountedtoSEK1.1(0.0)million,result-inginearningspershareofSEK0.05(0.00),affectedbyamortizationanddepreciationofSEK3.1(2.7)million.

•CashflowfromoperatingactivitieswasSEK5.3(-5.9)millionandthecashatbankincreasedbySEK1.5milliontoSEK42.7millioncomparedtothelastquarteroflastyear.

•Warmperfusionsalesfromnon-durablegoods(STEENSolution™,productsandservicesrelatedtotheuseoftheXPS™)accountedfor31(30)percentofthetotalsalesofnon-Durablegoods.Totalsalesfromwarmperfu-sion(STEENSolution™,productsandservicesrelatedtotheuseoftheXPS™andXPS™)accountedfor40(45)percentofthetotalsales.

•Duringthequarter3XPS™weresold,ofwhich2toEuropeand1totheUS.FranceandSwitzerlandwerenewcountriesthatgotaccesstotheXPS™duringthequarter.

•XVIVOPerfusionhasbeengrantedaCEmarkforapatent-protectedproduct,PrimECC®,developedtoprimetheheart-lungmachinebeforeopenheartsurgery.ThecompanywillexpandtheclinicaldocumentationforPrimECC®throughadditionalclinicalstudiesin2016.

•XVIVOPerfusionAB’sshareswereadmittedfortradingonNasdaqFirstNorthPremier8February2016.Thecompany'sshareswillcontinuetradingwiththesameshortnameandISINcode.

•Russia’sFederalServiceforSupervisiononHealthCarehasapprovedPerfadex®andSTEENSolution™forlungtransplantation.ThismeansthatPerfadex®andSTEENSolution™maybesoldforclinicaluseinRussia.

SIGNIFICANT EVENTS AFTER THE END OF THE QUARTER •Boston'sBrighamandWomen'sHospitalisthefirstclinicintheNewEnglandareaofUSAtosignanXPS™contract.

•XVIVOPerfusionannouncesarecommendedpublicoffertotheholdersofsharesandwarrantsofseries2015/2016inVivolineMedical.

•Atthetimeofpublicationofthisreport,25clinicshaveaccesstotheXPS™,including18clinicsintheUSand6clinicsinEurope.

*SalesgrowthislocalcurrencygrowthandEBITDAmarginisexcludingone-timecosts.**Seenote3forrevenuepersegment.

MILESTONES PASSED DURING THE YEAR

PrimECC®hasbeengrantedaCEmark.

ThefirstXPS™deliveredtoFranceandSwitzerland.

XVIVOPerfusionAB’sshareswereadmittedfortradingonNasdaqFirstNorthPremier.

3InterimReportJanuary–March2016XVIVOPerfusionAB,org.nr.556561-0424

CONFERENCE CALLCEOMagnusNilssonwillpresentthereportinaconferencecallat2p.m.CETonTuesday,April26,2016.Telephone:+44(0)1452555566,entercode76364070.

CEO’SCOMMENTSThefirstquartersawaverypositivebreakthroughintheEuropeanmar-ketforXVIVOPerfusion’sproductsforExVivoLungPerfusion(EVLP),theXPS™andSTEENSolution™.This means that the company has nowinstalledsixXPS™systemsatleadingclinicsinEuropeandthecompanynotescontinuedgreatinterestthere.Alargerinstallation

basecreatesagreatermarketpresenceandmorecustomercontacts.ThispositivespiralleadstoagreaterinterestfromclinicsandthepossibilityofmorelungtransplantsbeingperformedusingtheXPS™andSTEENSolution™.WehaveseenthispositivegenerativeprocessdevelopintheUSoverthepasttwoyears,whichhasresultedinalargeinstallationbaseoftheXPS™and,afterastart-upperiod,increasingsales.Inthelightofthis,weareextrapleasedtobeabletonotethatthefouradditionstostrengthenourpersonnelwithinsalesandcustomersupporttowardstheendof2015havealreadybeguntoshowclearresults.

TheclinicalstudyonSTEENSolution™withinthefieldoflivertransplantationisongoingandhasproducedgoodclinicalresults.Thefirstresultswererecentlypresentedataconfer-enceintheUS,andthisarousedgreatinterest.Twootherpromisingandexcitingclinicalstudiesonthecompany’sprod-uctswillstartsoon.ThefirstoftheseisacancerstudyusingSTEENSolution™,wherepatientswithcancermetastasesinthelungsaretreatedbyisolatingthemetastasesinthebodyfromthebloodcirculationandsubsequentlyperfusingthemwithSTEENSolution™containingaddedcytostatic.Theaimofthetreatmentistoavoidadverseeffectsintissuesthatarenottobetreatedandatthesametimeoptimizethedosageofcytostatic.Thesecondstudy,whichwillbecarriedoutatSahlgrenskaUniversityHospital,incorporatesthecompany’snewproductPrimECC®,whichaimstoavoidadverseeffectsinpatientsundergoingheartsurgeryproceduresusingaheart-lungmachine,forexamplebypassoperationsandheartvalvereplacementsurgery.

AftertheendofthequarterXVIVOPerfusionpublishedarecommendedpublicoffertotheownersofsharesandwarrantsinVivoline.Vivoline’sthreelargestshareholders,whotogetherownalmosthalfofthecompany,havecom-mittedtoacceptingtheoffer.ThestrategicaimofXVIVOPerfusionistocontinuetofurtherbuildonthescientific,technical,regulatoryandmarketcompetencethathasmadeusaleaderinthepreservationandwarmperfusionoflungsfortransplantationsoastobecomealeaderwithintheentirethoraxtransplantationarea.AbsolutelythemostimportantreasonforcombiningthetwocompaniesisthatthemergedcompanywillcreatemoreresourcesandcompetencetotakeStigSteen’sworld-leadingresearchinhearttransplantationtothecommercialphase–throughtheproductdevelopmentphaseviaclinicaldevelopmentandregulatoryapprovaloutontotheglobalmarket.Thisisaverycapitalandresourceintensiveprocess,somethingwhichisagreatburdenforsmallcompanies.Intheeventofmarketapproval,therewillalsobeopportunitiesforarapidmarketintroductionusingXVIVOPerfusion’swell-developedglobalsalesandmarketingorganization.AstheofferislargelypaidinXVIVOPerfusionshares,thismeansthatbothXVIVOPerfusion’sandVivoline’sshareholderswillbegiventheopportunitytobepartofthebuildingofastrong,innovative,internationalmedicaldevicecompanybasedinSweden.

However,itisimportanttopointoutthatwithorwithoutthisdeal,XVIVOPerfusionstandsstrongafteryetanotherquarterofgoodsalesdevelopmentonbothsidesoftheAtlantic,increasedgrowthpotentialwithnewindicationsandproductsandwherethecompany’sstrongcashflowsecurescontinuedaggressiveinvestmentinproductdevelopmentandmarketexpansion.

MagnusNilssonCEO


*Seenote3forrevenuepersegment.

COMPILATION OF NET SALES AND EBITDA January - March Wholeyear

TSEK 2016 2015 2015Net Sales non-Durable Goods 29 054 25 122 105 977NetSalesDurableGoods 4 477 6698 14268NetSalesTotal 33531 31820 120 245

Cost of Goods non-Durable Goods -5 916 -5 999 -23 826CostofGoodsDurablegoods -3363 -6306 -11459CostofGoodsTotal -9279 -12305 -35285

Gross income non-Durable Goods 23 138 19 123 82 151Gross margin non-Durable Goods, % 80% 76% 78%GrossincomeDurableGoods 1 114 392 2809GrossincomeTotal 24 252 19515 84960GrossmarginTotal,% 72% 61% 71%

CostsbeforedepreciationandamortizationSellingexpenses -7 521 -7372 -32052Administrativeexpenses -6326 -3144 -12638Researchanddevelopmentcosts -5 405 -5 660 -20931Otheroperatingrevenuesandexpenses -130 -456 -538

EBITDA 4 870 2 883 18 801EBITDA in relation to Sales non-Durable Goods, % 17% 11% 18%EBITDAinrelationtoNetSalesTotal,% 15% 9% 16%

AmortizationandDepreciation -3094 -2698 -11589

Operating income 1 776 185 7 212

FIRST QUARTER 2016 (JANUARY - MARCH)NET SALESXVIVOPerfusion’snetsalesofnon-Durablegoods*inthequarteramountedtoSEK29.1(25.1)million,correspondingtoanincreaseof16percentinSEKandanincreaseof17percentin

localcurrency.TotalnetsalesinthequarteramountedtoSEK33.5(31.8)million,correspondingtoanincreaseof5percent.Warmperfusionsalesfromnon-durablegoods(STEENSolution™,productsandservicesrelatedtotheuseoftheXPS™)accountedfor31(30)percentofthetotalsalesofnon-Durablegoods.Totalsalesfromwarmperfusion(STEENSolution™,productsandservicesrelatedtotheuseoftheXPS™andXPS™)accountedfor40(45)percentofthetotalsales.


INCOMEOperatingincomebeforedepreciationandamortization(EBITDA)amountedtoSEK4.9(2.9)million,correspondingtoanEBITDAmarginof15percent.One-timeexpensesofSEK2.4millionrelatedtotheNasdaqStockholmmainmarketlistingandthepublicofferforVivolinehavebeenchargedagainstthequarter.EBITDAexcludingone-timeexpensesamountedtoSEK7.3(4.5)million,correspondingtoanEBITDAmarginof22percent.

Thegrossmarginfornon-Durablegoodsduringthequarterwas80(76)percentandtheincreaseismainlyattributabletohigherpricesoncertainproducts.Thetotalgrossmarginduringthequarterwas72(61)percentmainlyduetolowerportionofXPS™sales.

Sellingexpensesinrelationtosaleswere22(23)percent.DuringthequarteradditionalresourceshavebeeninvestedinthecontinuedestablishmentofSTEENSolution™andXPS™intheUSandEurope,primarilybyhiringtwoserviceandtrain-ingspecialistsintheUSA.R&Dcostswere24(26)percentofsales.Thedecreaseismainlyduetoeconomiesofscaleandthatlegalone-timeexpensesofSEK1.7millionwerechargedagainstthesamequarterlastyear.Administrativeexpensesincreasedto19(10)percent,theincreaseismainlyduetoone-timeexpensesofSEK2.4millionrelatedtotheNasdaqStockholmmainmarketlistingandthepublicofferforVivolinethathavebeenchargedagainstthequarter.TheAdministrationdepart-menthasbeenstrengthenedwithoneemployeeintheUSAcomparedtothesamequarterlastyear.NetotheroperatingrevenuesandexpensesduringthequarterwereSEK-0.6(-0.5)million.Duringthequarter,SEK1.4million(1.0)ofthedevel-opmentcostsforSTEENSolution™werecapitalizedasanintangibleasset.ThewholesumisattributabletothecontinuedNOVELstudywiththeaimofPMAapproval.DepreciationandamortizationfortheperiodamountedtoSEK3.1million(2.7),ofwhichSEK2.4(2.4)millionisamortizationoftheFDAHDEapproval.

CASH FLOWCashflowfromoperatingactivitiesamountedtoSEK5.3(-5.9)million.InvestmentsamountedtoSEK3.6(3.0)million,ofwhichSEK1.4(1.0)millionwasinvestedinthecontinuedNOVELstudywiththeaimofPMAapproval.Thecashflowfromfinanc-ingactivitieswasSEK0.0(0.0)million.Cashandcashequiva-lentsattheendofthequarteramountedtoSEK42.7(39.7)million.

FINANCINGXVIVOPerfusion’stotalcreditfacilitiesconsistofanoverdraftfacilitythatattheendofthequarteramountedtoSEK20(20)million,ofwhichSEK0.0(0.0)millionwasutilized.Theequity/assetsratiowas90(91)percentattheendofthequarter.

XVIVO PERFUSION AB ADMITTED TO TRADING ON NASDAQ FIRST NORTH PREMIER XVIVOPerfusionappliedforlistingofXVIVOPerfusion’ssharesonNasdaqFirstNorthPremieraspartofpreparingthecom-panyforlistingontheNasdaqStockholm'smainlist.NasdaqapprovedtheCompany'sapplicationandthefirstdayoftradinginXVIVOPerfusion’ssharesonNasdaqFirstNorthPremierwas8February2016.Thecompany'sshareswillcontinuetrad-ingwiththesameshortnameandISINcode. PRIMECC HAS BEEN GRANTED CE MARK XVIVOPerfusionhasbeengrantedaCEmarkforapatent-protectedproduct,PrimECC®,whichisusedtoprimetheheart-lungmachinebeforeopenheartsurgery.PrimECC®wasdevelopedinearliercollaborationwithProfessorStigSteentomimictheblood’sphysicalandchemicalproperties.Thisistoavoidthestressthattherapidadditionofalargequan-tityofnon-optimizedfluidcancausethebodywhenprimingheart-lungmachinesforpatientsundergoingheartsurgeryprocedures,forexamplebypassoperationsandheartvalvereplacementsurgery.TheaimofPrimECC®istominimizeadverseeffectsthatmayariseduringandafteruseofaheart-lungmachine.A“proofofconcept”studyperformedusingPrimECC®hasshowninterestingclinicalresults.Inordertoexpandthedocumentation,thecompanywillperformarand-omizedclinicalstudyon80patientsatSahlgrenskaUniversityHospitalinGothenburgin2016.XVIVOdoesnotplananyextensivelaunchoftheproductbeforethisstudyiscomplete.XVIVOPerfusionhasappliedforapatentforPrimECC® in importantmarketsandhassofarbeengrantedapatentintheUSAandtheEU.

OUTLOOKFOR2016Asthenumberoflungsthatcanbetransplantedusingtradi-tionalcoldperfusioncannotbepredictedtoincreasemorethanthenumberoflungsdonated,itisexpectedthatgrowthwillcomeprimarilyfromwarmperfusionusingtheSTEENSolution™method.Thefocusduring2016isthereforetoestablishtheSTEENSolution™methodasthestandardtreat-mentforlungtransplantation.WeseeincreasedinterestinEuropeandAustraliafortheXPS™systemandthefocuswillbeontheXPS™launch,aswellasonestablishingtheSTEENSolution™methodatmoreclinicsbymeansofthegoodclini-calresultsdemonstratedsofar.Approximatelyfivepercentofthetotalnumberoflungtransplantsintheworldtodayarecar-riedoutinAsia,theMiddleEastandEasternEurope,butwithgreatereconomicstrengththenumberoflungtransplantswillincrease.ByestablishingtheSTEENSolution™methodearlyinthesemarkets,thisdevelopmentcanbemorerapidthanwouldotherwisehavebeenpossible.

IntheUSAthemainfocuswillbeonthelaunchofSTEENSolution™andXPS™andaboveallonasmanyclinicsas


possiblegainingaccesstoandbeginningtouseXPS™andwarmperfusionwithSTEENSolution™clinically.ResourcesforsalesandmarketingintheUSAwillbeincreasedtoestablishtheSTEENSolution™technology,andthisisexpectedtocontributepositivelytosalesduringtheyear.AmortizationofthecapitalizedexpensesforSTEENSolution’s™HDEapprovalwillbechargedagainstincomeduring2016tothetuneofSEK9.8million.TheclinicalNOVELstudywillcontinuewiththegoalofattainingPMAapprovalintheAmericanmarket(currentapprovalisaso-calledHDE,HumanitarianDeviceExemption).ExpensesforthecompanyrelatedtodocumentingtheresultsofthisPMAstudywillbecapitalizedonanongoingbasis.

Lungavailabilityisalsothelimitingfactorforincreasingthenumberoftransplantationsofotherorgansthanlungs.ThefocusofresearchanddevelopmentisthereforeondevelopingtheuseoftheSTEENSolution™methodformoreindicationsandondevelopingothersimilarareasofusesuchasthewarmperfusionoforgansstillinthebody.

THE COMPANY IN BRIEFOPERATIONS XVIVOPerfusionABisamedicaltechnologycompanywhichdevelopssolutionsandsystemsforselectingusableorgansandmaintainingtheminoptimalconditionpendingtransplantation.Today,thecompany’sproductPerfadex®hasamarketshareofmorethan90percentinthetraditionalpreservationoflungsfortransplantation.Thecompany’sproductsXPS™andSTEENSolution™forwarmperfusionaretheonlyproductsonthemarketthathaveFDAapprovalforwarmperfusionoflungsinthe US.

LUNG TRANSPLANTATIONAgreatproblemintransplantationhealthcareisthelackofavailablelungs.CurrentlyintheUSA,onlyaround20percentoftheavailabledonatedlungsaretransplantedasitiscon-sideredfartooriskytotransplanttheremainingmajority.ByusingXVIVOPerfusion'sproductSTEENSolution™,theorganisclearedofharmfulsubstancesfromthedonor,thuscreat-ingabetterenvironmentfortheorgan’scells.Thetechnologytherebyallowstheorganto“recover”whenpossible.Italsoallowsforfunctionaltestingtobeperformedoutsidethebody.InclinicaluseintheUS,Europe,AustraliaandCanadaithasemergedthatonceSTEENSolution™perfusionhasbeencarriedout,manyoftheorgansthatwereinitially“refused”areassessedasbeingusableandhavebeensuccessfullytrans-plantedintopatientswithendstagelungdisease.ThereforetheuseofSTEENSolution™hasthepotentialtoincreasethetotalnumberoflungtransplants.

NEW INDICATIONSThecompanyconductspreclinicalandclinicalresearchintrans-plantationofotherorgansthanlungsaswellasdrugdeliverytoanisolatedorgan.

BUSINESS CONCEPTXVIVOPerfusion’sbusinessconceptistoincreasethesurvivalrateofpatientsinneedofanorgantransplantbyprovidingeffectiveproductsthatincreasetheavailabilityandsurvivalpotentialoforgansoncetransplanted.

VISIONThecompany’svisionisthatnooneshouldhavetodiewaitingforaneworgan.

OBJECTIVEThecompany’sobjectiveistoestablishthewarmperfusionoforganswithXPS™andSTEENSolution™asthestandardtreatmentinthetransplantationoflungsandotherorgans.

STRATEGY XVIVOPerfusion’sstrategyfocusesongettinglungevalua-tionoutsidethebodyusingtheXPS™andSTEENSolution™acceptedasastandardprocedure.AbasicpreconditionofthestrategyistoobtainregulatoryapprovalforSTEENSolution™inallimportantmarkets.XVIVOPerfusionhasdemonstratedthroughpublishedpreclinicalandclinicalstudiesthatwarmperfusionoforgansusingtheSTEENSolution™methodresultsinmoreavailableorgans,therebygivingmorepatientsthepotentialtohavealife-savingtreatment,betterqualityoflife,socioeconomicgains,andlowermorbidityandmortality.Furthermore,thecompanywillstrivetoincreaseawarenessoftheSTEENSolution™methodinimportantgroupsofstake-holdersandwillworkwithkeyopinionleadersinthearea.

OTHER INFORMATIONORGANIZATION AND PERSONNELAttheendofquarterthenumberofemployeeswas22,ofwhom10werewomenand12weremen.Ofthese,10peoplewereemployedinSwedenand12intheUSA.Inaddition,thecompanyusesaroundfiveconsultants.

INFORMATION ON TRANSACTIONS WITH RELATED PARTIESNotransactionsthathavesubstantiallyaffectedthecompany’sresultsandfinancialpositionhavebeencarriedoutwithrelatedpartiesduringthequarter.

RISK MANAGEMENTXVIVOPerfusionisconstantlyworkingtoidentify,evaluate,andmanagerisksindifferentsystemsandprocesses.Riskanalysesareperformedcontinuallywithregardtothecompany’snormalbusinessactivitiesandalsoinconnectionwithactivitiesthatareoutsideXVIVOPerfusion’sregularqualitysystem.

Themarketrisksthataredeterminedtohaveparticularimpor-tanceforthefuturedevelopmentofXVIVOPerfusionareaccesstofinancialfundsandmedicalresourcesatclinicsaround


theworld.OperationalrisksprimarilycompriserisksthatlimitorpreventXVIVOPerfusionfromdeveloping,manufacturingandsellingquality,effectiveandsafeproducts.Legalandregula-toryrisksmayarisefromchangesinlegislationandotherregu-lations.Changesinlegislationorpoliticaldecisionsmayaffectthecompany’sabilitytorunordevelopthebusiness.Includingfinancialrisksarethecurrencyriskforthebusiness.

Themostimportantstrategicandoperativerisksaffectingthecompanyaredescribedinthe2015annualreport.

SEASONAL EFFECTSXVIVOPerfusion’ssalesaremarginallyaffectedbyseasonaleffects.MainlyinnewtreatmentssuchasEVLPorwarmperfu-sionofthelungsthereareslightlylessactivityduringthesum-mer months.

EVENTS AFTER THE END OF THE REPORTING PERIODOnApril18,2016XVIVOPerfusionABannouncedarecom-mendedpublicoffertotheholdersofsharesandwarrantsofseries2015/2016inVivolineMedicalAB.ForeveryShare,SEK1.2921incashand0.1543sharesinXVIVOPerfusionareofferedandforeveryWarrantSEK0.7226incashand0.0863BidderSharesareoffered.TheConsiderationcorrespondstoavalueofapproximatelySEK9.32perShareandapproximatelySEK5.21perWarrant.Basedonatotalnumberof11,402,818outstandingSharesand4,267,970outstandingWarrantsatthetimeoftheannouncementoftheOffer,thetotalvalueoftheOfferamountstoapproximatelySEK128.5million.Vivoline’sthreelargestshareholders,withacombinedhold-ingofapproximately48.1%ofthetotalnumberofSharesandvotesinVivolineandapproximately38%ofthetotalnumberofWarrants,haveundertakentoaccepttheOffer.SubjecttoVivolinebecomingawholly-ownedsubsidiaryofXVIVOPerfusion,anewresearchagreementbetweenIgelösaLifeScienceABandXVIVOPerfusionwillenterintoforce.

ANNUAL GENERAL MEETINGTheAnnualGeneralMeetingwillbeheldonMay3,2016,atXVIVOPerfusion’spremisesinGothenburg,visitors’addressMässans gata 10.

April26,2016Gothenburg

TheBoard

THIS REPORT HAS BEEN BRIEFLY REVIEWED BY THE COMPANY’S AUDITORS.

FINANCIAL REPORTSXVIVOPerfusion’sinterimreportsarepublishedonthecom-pany’swebsite,www.xvivoperfusion.com.Followingreportsareplannedtobesubmittedin2016:

InterimreportApril-June:Friday,July15InterimreportJuly-September:Thursday,October27

FOR FURTHER INFORMATION, PLEASE CONTACTMagnusNilsson,CEO,+46317882150, [email protected],CFO,+17206162101, [email protected]

TheCertifiedAdviserisRedeye,www.redeye.se

XVIVO Perfusion is required to publish the information in this report in accordance with the Swedish Securities Market Act and/or the Financial Instruments Trading Act. The information was submitted for publication on April 26, 2016 at 8.30 am.

ThisisatranslationoftheSwedishversionofthereport.Whenindoubt,theSwedishwordingprevails.


CONSOLIDATED INCOME STATEMENTS IN SUMMARY January – March Wholeyear

SEKTHOUSANDS 2016 2015 2015Netsales 33531 31820 120 245Costofgoodssold -9279 -12305 -35285Gross income 24 252 19 515 84 960

Sellingexpenses -7 521 -7372 -32052Administrativeexpenses -6437 -3240 -13154Researchanddevelopmentcosts -7958 -8262 -31086Otheroperatingrevenuesandexpenses -560 -456 -1 456Operating income 1 776 185 7 212

Financialincomeandexpenses -72 55 186Income after financial items 1 704 240 7 398

Taxes -590 -289 -2 267Net income 1 114 -49 5 131

Attributable toParentCompany’sshareholders 1 114 -49 5131

Earningspershare,SEK 0.05 0.00 0.24Earningspershare,SEK* 0.05 0.00 0.24Averagenumberofoutstandingshares 21512769 21512769 21512769Averagenumberofoutstandingshares* 21512769 21707769 21561519Numberofsharesatclosingday 21512769 21512769 21512769Numberofsharesatclosingday* 21512769 21707769 21512769

EBITDA 4 870 2 883 18 801Amortization -2553 -2 546 -10 155Depreciation -541 -152 -1434Operating income 1 776 185 7 212

*Afterdilution.Seenote2forinformationonwarrantprograms.

STATEMENT OF COMPREHENSIVE INCOME January – March Wholeyear

SEKTHOUSANDS 2016 2015 2015Net income 1 114 -49 5 131

Other comprehensive incomeItems that may be reclassified to the income statementExchangeratedifferences -1 060 4980 3119Taxattributabletoitemsthathavebeentransferred,orcanbetransferredtonetincome 69 -543 -328Total other comprehensive income, net after tax -991 4 437 2 791Total comprehensive income 123 4 388 7 922

Attributable toParentCompany’sshareholders 123 4388 7922


CONSOLIDATED BALANCE SHEETS IN SUMMARY SEKTHOUSANDS March31,2016 March31,2015 Dec31,2015ASSETSGoodwill 3755 3974 3849Otherintangiblefixedassets 92109 95698 93086Tangiblefixedassets 8663 2809 7123Financialandotherfixedassets 3430 4393 4487Inventories 25 006 26938 28598Accountsreceivable 21043 22 112 19513Othercurrentreceivables 9216 5 402 6290Liquidfunds 42 722 39663 41234Total assets 205 944 200 989 204 180

SHAREHOLDERS' EQUITY AND LIABILITIESShareholders’equity,attributabletotheParentCompany’sshareholders 184997 182578 184874Provisions 3791 3607 3725Accountspayable 4797 5839 3650Currenttaxliabilities 952 1375 1 574Othershort-termliabilities 594 602 729Accruedexpensesandprepaidincome 10813 6988 9628Total shareholders’ equity and liabilities 205 944 200 989 204 180

Pledgedassetsforownliabilities 20 224 20 226 20223Contingentliabilities - - -

CONSOLIDATEDKEYRATIOS

January – March Wholeyear 2016 2015 2015GrossMarginnonCapitalgoods,% 80 76 78Gross margin, % 72 61 71OperatingmarginbeforeR&Dcosts,% 29 27 32EBITDAportionofnetsalesnonCapitalgoods,% 17 11 18EBITDA, % 15 9 16Operating margin, % 5 1 6Net margin, % 3 0 4Equity/assetsratio,% 90 91 91Returnonequity,% 1 0 3Incomepershare,SEK 0.05 0.00 0.24Shareholders’equitypershare,SEK 8.60 8.49 8.59Sharepriceonclosingday,SEK 50.25 42.70 58.50


CONSOLIDATED CASH FLOW STATEMENTS IN SUMMARY

January – March WholeyearSEKTHOUSANDS 2016 2015 2015Incomeafterfinancialitems 1 704 240 7398Adjustmentforitemsnotaffectingcashflow 3913 2 650 11 510Paidtaxes -2897 -520 -3438Changeininventories 3065 1380 -1130Changeintradereceivables -2 257 -8336 -6 025Changeintradepayables 1 766 -1345 263Cash flow from operating activities 5 294 -5 931 8 578Cashflowfrominvestingactivities -3639 -2994 -14290Cashflowfromfinancingactivities 0 0 -1468Cash flow for the period 1 655 -8 925 -7 180

Liquidfundsatbeginningofperiod 41234 48203 48203Exchangeratedifferenceinliquidfunds -167 385 211Liquid funds at end of period 42 722 39 663 41 234

CONSOLIDATED CHANGES IN SHAREHOLDERS' EQUITY

AttributabletoParentCompany'sshareholders

SEKTHOUSANDS

Share capital

Other paidin capital Reserves

Retained earningsincl.

profit for the year

Sum shareholders'

equityOpening balance January 1, 2015 550 154 466 6 349 17 055 178 420Totalcomprehensiveincome 2791 5131 7922Sharewarrantprogram 101 101Repurchaseofwarrants -1569 -1569Closing balance December 31, 2015 550 154 567 9 140 20 617 184 874

Opening balance January 1, 2016 550 154 567 9 140 20 617 184 874Totalcomprehensiveincome -991 1 114 123Closing balance March 31, 2016 550 154 567 8 149 21 731 184 997


CONSOLIDATED INCOME STATEMENTS PER QUARTER

Jan - Mar Oct - Dec Jul-Sep Apr - Jun Jan - Mar Oct - Dec Jul-Sep Apr - JunSEKTHOUSANDS 2016 2015 2015 2015 2015 2014 2014 2014Netsales 33531 32680 26618 29127 31820 25543 22 427 18474Costofgoodssold -9279 -8055 -7528 -7397 -12305 -5937 -6 474 -3863Gross income 24 252 24 625 19 090 21 730 19 515 19 606 15 953 14 611

Sellingexpenses -7 521 -9095 -6878 -8707 -7372 -5794 -5586 -6313Administrativeexpenses -6437 -3384 -3035 -3495 -3240 -3034 -2495 -3023Researchanddevelopmentcosts -7958 -7877 -7513 -7433 -8262 -10 474 -5 461 -3811Otheroperatingrevenuesandexpenses -560 -475 -129 -396 -456 196 52 125Operating income 1 776 3 794 1 535 1 699 185 500 2 463 1 589

Financialincomeandexpenses -72 -122 381 -127 55 166 36 -81Income after financial items 1 704 3 672 1 916 1 572 240 666 2 499 1 508

Taxes -590 -874 -579 -526 -289 -382 -659 -412Net income 1 114 2 798 1 337 1 046 -49 284 1 840 1 096

Attributable toParentCompany’sshareholders 1 114 2798 1337 1 046 -49 284 1840 1096

Earningspershare,SEK 0.05 0.13 0.06 0.05 0.00 0.01 0.09 0.06Earningspershare,SEK* 0.05 0.13 0.06 0.05 0.00 0.01 0.08 0.06Averagenumberofoutstandingshares 21512769 21512769 21512769 21512769 21512769 21512769 21512769 19562769Averagenumberofoutstandingshares* 21512769 21512769 21512769 21512769 21707769 21707769 21707769 19757769Numberofsharesatclosingday 21512769 21512769 21512769 21512769 21512769 21512769 21512769 19562769Numberofsharesatclosingday* 21512769 21512769 21512769 21512769 21707769 21707769 21707769 19757769

EBITDA 4 870 6 881 4 440 4 597 2 883 3 107 3 445 1 756Amortization -2553 -2 504 -2 557 -2 547 -2 546 -2543 -916 -102Depreciation -541 -583 -348 -351 -152 -64 -66 -65Operating income 1 776 3 794 1 535 1 699 185 500 2 463 1 589

*Afterdilution.Seenote2forinformationonwarrantprograms.

STATEMENTS OF COMPREHENSIVE INCOME

Jan - Mar Oct - Dec Jul-Sep Apr - Jun Jan - Mar Oct - Dec Jul-Sep Apr - JunSEKTHOUSANDS 2016 2015 2015 2015 2015 2014 2014 2014Net income 1 114 2 798 1 337 1 046 -49 284 1 840 1 096

Other comprehensive incomeItems that may be reclassified to the income statement

Exchangeratedifferences -1 060 -182 549 -2 201 4980 3577 2 205 1345Taxattributabletoitemsthathavebeen transferred,orcanbetransferredto net income 69 19 -11 207 -543 -395 -163 -143Total other comprehensive income, net after tax -991 -163 538 -1994 4437 3182 2 042 1 202Total comprehensive income 123 2 635 1 875 -948 4 388 3 466 3 882 2 298

Attributable toParentCompany’sshareholders 123 2 635 1 875 -948 4 388 3 466 3 882 2 298


INCOME STATEMENTS FOR THE PARENT COMPANY IN SUMMARY

January – March WholeyearSEKTHOUSANDS 2016 2015 2015Netsales 19254 16853 80761Costofgoodssold -6855 -5 524 -19065Gross income 12 399 11 329 61 696

Sellingexpenses -4053 -4 161 -19804Administrativeexpenses -4 677 -2364 -9431Researchanddevelopmentcosts -7958 -7912 -31090Otheroperatingrevenuesandexpenses -560 -460 -1 540Operating income -4 849 -3 568 -169

Financialincomeandexpenses -388 2 521 1 661Income after financial items -5 237 -1 047 1 492

Taxes 958 - -464Net income -4 279 -1 047 1 028

TheParentCompanyhasnoitemstoreportasothercomprehensiveincome,thereforeastatementofcomprehensiveincomeisnotpresented.DepreciationandamortizationhasreducedincomefortheperiodbySEK3012thousand(2585).

BALANCE SHEETS FOR THE PARENT COMPANY IN SUMMARY SEKTHOUSANDS March31,2016 March31,2015 Dec31,2015ASSETSBalancedexpendituresfordevelopment 90698 94387 91797Patentsandlicencies 1391 1286 1268Trademarks 19 24 21Tangiblefixedassets 7 460 1910 6 127Participationinaffiliatedcompanies 14 475 14 475 14 475Otherfinancialfixedassets 1179 922 1179Inventories 6582 12532 7129Accountsreceivable 10168 6995 4338Receivablesfromaffiliatedcompanies 19080 20 501 32924Othercurrentreceivables 8726 5 061 5 721Liquidfunds 34297 37306 32111Total assets 194 075 195 399 197 090

SHAREHOLDERS' EQUITY AND LIABILITIESShareholders’equity 168868 171 700 173147Untaxedreserves 12238 12238 12238Provisions 1099 915 1033Accountspayable 2 515 2939 1956Currenttaxliabilities 674 1 500 746Othershort-termliabilities 8681 6 107 7970Total shareholders’ equity and liabilities 194 075 195 399 197 090

Pledgedassetsforownliabilities 20 224 20 226 20223Contingentliabilities - - -


NOTE 1. ACCOUNTING PRINCIPLES FortheGroup,thereportispresentedpursuanttotheSwedishAnnualAccountsActand IAS34, InterimFinancialRepor ting,and for theParentCompanypursuant to theSwedishAnnualAccountsAct and theSwedishFinancialReportingBoard’srecommendationRFR2AccountingforLegalEntities.

Accounting principles applied for the Group and the parent companycorrespond,unlessotherwisestatedbelow,withtheaccountingpoliciesusedforthepreparationofthelatestannualreport.Noneworrevisedaccountingpoliciesthatbecameeffectivein2016havehadanysignificantimpactontheGroup.

NOTE 2. SHARE WARRANT PROGRAMS

Intotalthereare410,000outstandingwarrantsintwoprograms.Ifallthewar-rantsareexercisedtosubscribeforshares,thesharecapitalwillincreasebyaroundSEK10,500andthenumberofshareswillincreaseby410,000sharesintotal,correspondingtodilutionofapproximately1.9percentofthetotalnumberofsharesandvotes.Sharewarrantprogram2014/2016consistsof195,000war-rantsandinJune2016eachwarrantwillentitletheholdertosubscribeforonenewshareatapriceofSEK58.60.Sharewarrantprogram2015/2017consistsof215,000warrantsandinJune2017eachwarrantwillentitletheholdertosubs-cribeforonenewshareatapriceofSEK60.92.

NOTE 3. FINANCIAL DATA PER SEGMENT, GROUP

January - March

Netsalesofnon-Durablegoods Durablegoods

Totalconsolidated

SEKThousands 2016 2015 2016 2015 2016 2015Netsales 29054 25 122 4 477 6698 33531 31820Costofgoodssold -5916 -5999 -3363 -6306 -9279 -12305Gross income 23 138 19 123 1 114 392 24 252 19 515

NOTE 4. FINANCIAL INSTRUMENTSTheGroup’sfinancialassetsandliabilitiesvaluatedatacquisitionvalueamounttoSEK68(62)millionandSEK17(15)millionrespectively.FairvalueoftheGroup’sfinancialassetsandliabilitiesisassessedtocorrespondtothebookvalue.

REVIEW REPORTTotheBoardofDirectorsofXVIVOPerfusionAB(publ)Corp.id.556561-0424

INTRODUCTIONWehavereviewedthesummaryinterimfinancialinformation(interimreport)ofXVIVOPerfusionAB(publ)asof31March2016andthethree-monthperiodthenended.TheBoardofDirectorsandtheManagingDirectorareresponsibleforthepreparationandpresentationofthisinterimreportinaccordancewithIAS34andtheAnnualAccountsAct.Ourresponsibilityistoexpressaconclusiononthisinterimreportbasedonourreview.

SCOPE OF REVIEWWeconductedourreviewinaccordancewithInternationalStandardonReviewEngagements ISRE 2410 Review of Interim Financial Information Performed by the Independent Auditor of the Entity.Areviewofinterimfinancialinformationconsistsofmakinginquiries,primarilyofpersonsresponsibleforfinancialandaccountingmatters,andapplyinganalyticalandotherreviewprocedures.Areviewissub-stantiallylessinscopethananauditconductedinaccordancewithInternationalStandardsonAuditingandothergenerallyacceptedauditingpracticesandcon-sequentlydoesnotenableustoobtainassurancethatwewouldbecomeawareofallsignificantmattersthatmightbeidentifiedinanaudit.Accordingly,wedonotexpressanauditopinion.

CONCLUSIONBasedonourreview,nothinghascometoourattentionthatcausesustobelievethattheinterimreportisnotprepared,inallmaterialrespects,fortheGroupinaccordancewithIAS34andtheAnnualAccountsAct,andfortheParentCompanyinaccordancewiththeAnnualAccountsAct.

Göteborg26April2016KPMGAB (Signatureontheoriginaldocument) JanMalmAuthorizedPublicAccountant


XVIVO Organ Chamber™

SALES TYPEWarm Perfusion

XPS PGM Disposable Sensors™


PERFADEX®

SALES TYPEColdPerfusion

Silicone Tubing Set™

SALES TYPEColdPerfusion

XPS™

SALES TYPEWarm PerfusionDurableGoods

STEEN Solution™


XPS Disposable Kit™


XVIVO Lung Cannula Set™


PRODUCTS

X V I VO P e r f u s i o n A B ( p u b l ) , B o x 5 3 0 1 5 , S E - 4 0 0 1 4 G ö t e b o r g . Te l : + 4 6 3 1 - 7 8 8 2 1 5 0 . F a x : + 4 6 3 1 - 7 8 8 2 1 6 9 .X V I VO Pe r f u s i o n I n c . , 3 6 6 6 S o u t h I n c a S t r e e t , E n g l e wo o d , CO 8 0 1 1 0 , U SA , Te l : + 1 3 0 3 3 9 5 9 1 7 1 , F a x + 1 8 0 0 6 9 4 5 8 9 7

WWW.XVIVOPERFUSION.COM

interim report january–march 2016 xvivo …...apr 26, 2016 · the company’s products xps™...

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