interim report january–march 2015 xvivo perfusion … · 5 interim report january – march 2015...
TRANSCRIPT
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 that received regulatory approval by the FDA for warm perfusion of lungs. XVIVO Perfusion employs 12 people at its headquarters in Gothenburg, Sweden, and five at its office for North & South America in Denver, USA. The XVIVO share is listed on NASDAQ OMX First North and has the ticker symbol XVIVO. The Certified Adviser is Redeye, www.redeye.se.
INTERIM REPORT JANUARY–MARCH 2015
XVIVO PERFUSION AB (PUBL)
2 Interim report January – March 2015 XVIVO Perfusion AB, org.nr. 556561-0424
STRONG GROWTH AND 6 XPS™ DELIVERED
FIRST QUARTER 2015 (JAN – MAR)•NetsalesinthequarteramountedtoSEK31.8(18.3)million,correspondingtoanincreaseof74percent.
•Operatingincomebeforedepreciationandamortization(EBITDA)excludingone-timeexpensesamountedtoSEK4.5(3.9)million,correspondingtoanEBITDAmar-ginof14percent.One-timeexpensesofSEK1.7(0.8)millionrelatedtothedisputeregardingthreeVivolinepatents/patentapplicationshavebeenchargedagainstthequarter.Operatingincomebeforedepreciationandamortization(EBITDA)amountedtoSEK2.8(3.1)mil-lion,correspondingtoanEBITDAmarginof9percent.
•NetincomeamountedtoSEK-1.0(1.8)million,result-inginearningspershareofSEK-0.05(0.09),affectedbyamortizationanddepreciationof2.8million.
•CashflowfromoperatingactivitieswasSEK-5.9(-3.3)millionduetoincreasedtradereceivableseffectingcashflowby-8.3SEKmillion.
•Netsalesofnon-Durablegoods*inthequarteramountedtoSEK25.1(18.3)million,correspondingtoanincreaseof38percentinSEK.Salesofnon-Durablegoodsincreasedby18percentinlocalcurrency.
•Productsforwarmperfusion(STEENSolution™andproductsrelatedtotheuseoftheXPS™)accountedfor30(24)percentofthetotalsalesofnon-Durablegoods.
•Duringthequarter6XPS™weredelivered,ofwhich2toEuropeand4totheUS.Attheendofthequarter19clinicshaveaccesstotheXPS™,ofwhich16arelocatedin the US.
•XVIVOPerfusionandVivolinehavereachedanagree-mentwhereby,amongstotherthings,XVIVOPerfusionwithdrawsitsclaimatLundDistrictCourtandcompen-satesVivolinefortrialcosts.Throughthisagreement,theparties'differencesinregardtothedisputehavebeendefinitivelysettled.
•XVIVOPerfusionhasreceivedTGAapprovalofXPS™(XvivoPerfusionSystem).ThisenablessalesofXPS™inAustralia.
•TheUnitedStatesPatentandTrademarkOffice(USPTO)hasapprovedathirdpatentinthe“Preservationandevaluationsolution”family.ThismeansthatSTEENSolution™hasbroaderpatentprotectioninthe USA.
*DurablegoodsaresalesrevenuesfromtheXPS™.Seetableonpage11inthebackofreportforproductdefinitions
CONFERENCE CALLCEOMagnusNilssonwillpresentthereportinaconferencecallat2p.m.CETonWednesday,April22,2015.Telephone:+44(0)1452555566,entercode15343045.
3InterimreportJanuary–March2015XVIVOPerfusionAB,org.nr.556561-0424
*DurablegoodsaresalesrevenuesfromtheXPS™.Seetableonpage11inthebackofreportforproductdefinitions**Q42012andquartersthereafterareXVIVOPerfusion’ssales.AllpreviousquartersderivefromVitrolife’sTransplantationsegment,asreportedinVitrolife’sreporting.
CEO’SCOMMENTSThefirstquarteroftheyearhasbeensuccessfulandeventfulinseveralareas.Theworkthatwasdonelastyearhaspaiddividends,aswehavedelivered6XPS™.Thesedeliveriesofcapitalgoodsleadtorecordgrowthof74percentfortotalsalesandwithoutcapitalgoodsthesalesincreasedby38percentcomparedtothesamequarterlast
year.ThestrongdevelopmentofsalesduringthequarterhasbeenaccompaniedbyacontinuinggoodgrossmarginandEBITDAof14percent,excludinglegalone-timeexpenses.Atthesametimethecompanymadelargeinvestmentsinmarketingandresearchduringthequarter.
Inordertosecurelong-termgrowth,opportunitiestoimprovepatentprotectionarebeingcontinuouslyinvestigatedandduringthequarterthecompanyobtainedabroadermethodpatentforSTEENSolution™intheUS.
WearepleasedtonotestronggrowthintheAmericanmarket,wheretheinstalledXPS™baseincreasedby4clinicstoatotalof16.Theseaccountforapproximately40percentofthetotalnumberoflungtransplantsthatarecarriedoutinthe USA. The company sees continuing strong interest from
Americanclinics.EuropeanclinicsarealsoshowinginterestinXPS™,andthishasresultedindeliveryofXPS™tobothGermanyandItalyduringthequarter.Duringcomingquar-tersthecompanywillcontinuetofocusonexpandingtheXPS™installationbase.
Ourbusinessmodelhasgoodscalabilitywithouttheneedforlargeinvestmentsinproductioncapacity.Thisallowsthecompanytocontinueinvestingforfuturegrowththroughabroaderproductportfolioandastrongermarketingorganization.
AfterasuccessfulstartoftheXPS™launch,welookfor-wardtotheyearstocomewithconfidence,asthecompanyhasauniquepatentedsolutionforwarmperfusionoflungs.Thissolutionhasthebestclinicaldocumentationandistheonlyonethathasregulatoryapprovalinalllargemarkets.OurbusinessfocusesonestablishingXPS™andSTEENSolution™globallyasthestandardtreatmentwhentrans-plantinglungs–andoncontinuingtoleadthedevelopmentofinnovativetechniqueswithinlungtransplantationanddevelopingwarmperfusionforotherorgansandindications.
MagnusNilssonCEO
FIRST QUARTER 2015 (JANUARY - MARCH)NET SALESXVIVOPerfusion’snetsalesofnon-Durablegoods*inthequarteramountedtoSEK25.1(18.3)million,correspondingto
anincreaseof38percentinSEKandanincreaseof18percentinlocalcurrency.TotalnetsalesinthequarteramountedtoSEK31.8(18.3)million,correspondingtoanincreaseof74percent.Productsforwarmperfusion(STEENSolution™andproductsrelatedtotheuseoftheXPS™)accountedfor30(24)percentofthetotalsalesofnon-Durablegoods.
4 Interim report January – March 2015 XVIVO Perfusion AB, org.nr. 556561-0424
INCOMEOperatingincomebeforedepreciationandamortization(EBITDA)amountedtoSEK2.8(3.1)million,correspondingtoanEBITDAmarginof9percent.One-timeexpensesofSEK1.7(0.8)millionrelatedtothedisputeregardingthreeVivolinepat-ents/patentapplicationshavebeenchargedagainstthequarter.EBITDAexcludingone-timeexpensesamountedtoSEK4.5million,correspondingtoanEBITDAmarginof14percent.
Thegrossmarginfornon-Durablegoodsduringthequarterwas76(76)percent.Thetotalgrossmarginduringthequarterwas61(76)percent.
Sellingexpensesinrelationtosaleswere23(27)percent.DuringthequarteradditionalresourceshavebeeninvestedinthecontinuedestablishmentofSTEENSolution™andXPS™intheUSandEurope.R&Dcostswere27(20)percentofsales.TheincreaseismainlyduetoamortizationoftheUSSTEENSolution™assetamountingtoSEK2.4millionandlegalone-timeexpensesofSEK1.7million.Administrativeexpensesdecreasedto10(14)percent,mainlyduetoeconomiesofscale.NetotheroperatingrevenuesandexpensesduringthequarterwereSEK-0.5(0.0)million,mainlyaffectedbycurrencytranslation.Duringthequarter,SEK1.0million(3.7)ofthedevelopmentcostsforSTEENSolution™werecapitalizedasan
intangibleasset.ThewholesumisattributabletothecontinuedNOVELstudywiththeaimofPMAapproval.DepreciationandamortizationfortheperiodamountedtoSEK2.8million(0.4),ofwhichSEK2.4millionisamortizationoftheFDAHDEapproval.
CASH FLOWCashflowfromoperatingactivitiesamountedtoSEK-5.9(-3.3),mainlyduetoincreasedtradereceivablesfromhighersalesaffectingcashflowbySEK-8.3million.InvestmentsamountedtoSEK3.0(3.8)million,ofwhichSEK1.0(3.7)mil-lionwasinvestedinthecontinuedNOVELstudywiththeaimofPMAapproval.ThecashflowfromfinancingactivitieswasSEK0.0(5.2)million.CashandcashequivalentsattheendofthequarteramountedtoSEK39.7(2.1)million.
FINANCINGXVIVOPerfusion’stotalcreditfacilitiesconsistofanoverdraftfacilitythatattheendofthequarteramountedtoSEK20(15)million,ofwhichSEK0.0(11.8)millionwasutilized.Theequity/assetsratiowas89(75)percentattheendofthequarter.
SETTLEMENT BETWEEN XVIVO PERFUSION AND VIVOLINE MEDICAL XVIVOPerfusionandVivolineMedicalhavereachedan
COMPILATION OF NET SALES AND EBITDA January - March Wholeyear
TSEK 2015 2014 2014Net Sales non-Durable Goods 25 122 18 258 83 229NetSalesDurableGoods 6698 0 1473NetSalesTotal 31820 18258 84702
Cost of Goods non-Durable Goods -5 999 -4 382 -19 187CostofGoodsDurablegoods -6306 0 -1469CostofGoodsTotal -12305 -4382 -20 656
Gross income non-Durable Goods 19 123 13 876 64 042Gross margin non-Durable Goods, % 76% 76% 77%GrossincomeDurableGoods 392 0 4GrossincomeTotal 19515 13876 64 046GrossmarginTotal,% 61% 76% 76%
CostsbeforedepreciationandamortizationSellingexpenses -7372 -4976 -22669Administrativeexpenses -3144 -2485 -10842Researchanddevelopmentcosts -5716 -3270 -19455Otheroperatingrevenuesandexpenses -456 -39 334
EBITDA 2 827 3 106 11 414EBITDA in relation to Sales non-Durable Goods, % 11% 17% 14%EBITDAinrelationtoNetSalesTotal,% 9% 17% 13%
AmortizationandDepreciation -2842 -368 -4726
Operating income -15 2 738 6 688
5 Interim report January – March 2015 XVIVO Perfusion AB, org.nr. 556561-0424
agreementwhereby,amongstotherthings,XVIVOPerfusionwithdrawsitsclaimatLundDistrictCourtandcompensatesVivolinefortrialcostsintheamountofapproximatelySEK1.6million.Thissumwaschargedtothefirstquarterof2015.Throughthisagreement,theparties'differencesinregardtothedisputehavebeendefinitivelysettled.
ThesettlementdoesnotaffectXVIVOPerfusion’scurrentoperationsandstrategy.Thecompany'sownproductsSTEENSolution™,whichisprotectedbypatentsgranteduntil2021(intheUSuntil2022),andPerfadex®arenotpartoftheunderly-ingdisputewhichthesettlementappliesto. XVIVO PERFUSION GRANTED METHOD PATENT FOR STEEN SOLUTION™ IN USA TheUnitedStatesPatentandTrademarkOffice(USPTO)hasapprovedathirdpatentinthe“Preservationandevaluationsolution”family.ThismeansnotonlythatSTEENSolution™hasbroaderpatentprotectionintheUSAbutalsothatXVIVOPerfusionhaspatentprotectionforuseofawidevarietyofalternativeperfusionsolutionsfororganperfusionandevalua-tion.Thepatentisvaliduntiltheendof2022.
XPS™ REGULATORY APPROVED IN AUSTRALIAXVIVOPerfusionhasreceivedTGAapprovalofXPS™(XvivoPerfusionSystem)inAustralia.ThisenablessalesofXPS™inAustralia.
OUTLOOKFOR2015Asthenumberoflungsthatcanbetransplantedusingtradi-tionalcoldperfusioncannotbepredictedtoincreasemorethanthenumberoflungsdonated,itisexpectedthatgrowthwillcomeprimarilyfromwarmperfusionusingtheSTEENSolution™method.Thefocusduring2015isthereforetoestablishtheSTEENSolution™methodasthestandardtreat-mentforlungtransplantation.WeseeincreasedinterestinEuropeandAustraliafortheXPS™systemandthefocuswillbeontheXPS™launch,aswellasonestablishingtheSTEENSolution™methodatmoreclinicsbymeansofthegoodclini-calresultsdemonstratedsofar.Approximatelyfivepercentofthetotalnumberoflungtransplantsintheworldtodayarecar-riedoutinAsia,theMiddleEastandEasternEurope,butwithgreatereconomicstrengththenumberoflungtransplantswillincrease.ByestablishingtheSTEENSolution™methodearlyinthesemarkets,thisdevelopmentcanbemorerapidthanwouldotherwisehavebeenpossible.
IntheUSAthemainfocuswillbeonthelaunchofSTEENSolution™andXPS™andaboveallonasmanyclinicsaspossiblegainingaccesstoandbeginningtouseXPS™andwarmperfusionwithSTEENSolution™clinically.ResourcesforsalesandmarketingintheUSAwillbeincreasedtoestablishtheSTEENSolution™technology,andthisisexpectedto
contributepositivelytosalesduring2015.AmortizationofthecapitalizedexpensesforSTEENSolution’s™HDEapprovalwillbechargedagainstincomeduring2015tothetuneofSEK9.8million.TheclinicalNOVELstudywillcontinuewiththegoalofattainingPMAapprovalintheAmericanmarket(currentapprovalisaso-calledHDE,HumanitarianDeviceExemption).ExpensesforthecompanyrelatedtodocumentingtheresultsofthisPMAstudywillbecapitalizedonanongoingbasis.
Lungavailabilityisalsothelimitingfactorforincreasingthenumberoftransplantationsofotherorgansthanlungs.ThefocusofresearchanddevelopmentisthereforeondevelopingtheuseoftheSTEENSolution™methodformoreindicationsandondevelopingothersimilarareasofusesuchasthewarmperfusionoforgansstillinthebody.
THE COMPANY IN BRIEFOPERATIONS XVIVOPerfusionABisamedicaltechnologycompanywhichdevelopssolutionsandsystemsforselectingusableorgansandmaintainingtheminoptimalconditionpendingtransplantation.Today,thecompany’sproductPerfadex®hasamarketshareofmorethan90percentinthetraditionalpreservationoflungsfortransplantation.Thecompany’sproductsXPS™andSTEENSolution™forwarmperfusionaretheonlyproductsonthemarketthathaveFDAapprovalforwarmperfusionoflungsinthe US.
Agreatproblemintransplantationhealthcareisthelackofavailablelungs.CurrentlyintheUSA,onlyaround20percentoftheavailabledonatedlungsaretransplantedasitisconsid-eredfartooriskytotransplanttheremainingmajority.ByusingXVIVO’sproductSTEENSolution™,theorganisclearedofharmfulsubstancesfromthedonor,thuscreatingabetterenvi-ronmentfortheorgan’scells.Thetechnologytherebyallowstheorganto“recover”whenpossible.Italsoallowsforfunctionaltestingtobeperformedoutsidethebody.InclinicaluseintheUS,Europe,AustraliaandCanadaithasemergedthatonceSTEENSolution™perfusionhasbeencarriedout,manyoftheorgansthatwereinitially“refused”areassessedasbeingusableandhavebeensuccessfullytransplantedintopatientswithendstagelungdisease.ThereforetheuseofSTEENSolution™hasthepotentialtoincreasethetotalnumberoflungtransplants.
Overtheyears,XVIVOhasestablishedcloserelationshipswithmostoftheworld’slungtransplantcentersandhasmadePerfadex®acompletelydominantproductinitsniche.XVIVOPerfusionintendstomakeSTEENSolution™availableallovertheworldwiththefirmconvictionthatthenumberoftrans-plantswillincreaseashealthcaresystemsgainknowledgeofandaccesstoSTEENSolution™.Theobjectiveofthecompanyistocreatevalueforbothpatientsandshareholdersbyprovidingauniqueproductinamarketwithgreatgrowthpotential.
6 Interim report January – March 2015 XVIVO Perfusion AB, org.nr. 556561-0424
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 PERSONNELAttheendofquarterthenumberofemployeeswasseventeen,ofwhomeightwerewomenandnineweremen.Ofthese,twelvepeoplewereemployedinSwedenandfiveintheUSA.Inaddition,thecompanyusesfiveconsultants.
INFORMATION ON TRANSACTIONS WITH RELATED PARTIESNotransactionsthathavesubstantiallyaffectedthecompany’sresultsandfinancialpositionhavebeencarriedoutwithrelatedpartiesduringthequarter.
RISK MANAGEMENTXVIVOPerfusionisconstantlyworkingtoidentify,evaluate,andmanagerisksindifferentsystemsandprocesses.Riskanalysesareperformedcontinuallywithregardtothecompany’snormalbusinessactivitiesandalsoinconnectionwithactivitiesthatareoutsideXVIVOPerfusion’sregularqualitysystem.Themostimportantstrategicandoperativerisksaffect-ingthecompanyaredescribedinthe2014annualreport.
SEASONAL EFFECTSXVIVOPerfusion’ssalesaremarginallyaffectedbyseasonaleffects.Thereisslightlylessactivityduringthesummermonths.
EVENTS AFTER THE END OF THE REPORTING PERIODNoeventshaveoccurredaftertheendofthereportingperiodthatsignificantlyaffecttheassessmentofthefinancialinforma-tion in this report.
ANNUAL GENERAL MEETING AND ANNUAL REPORTTheAnnualGeneralMeetingwillbeheldonThursdayApril23,2015,at4pmatXVIVOPerfusion’spremisesinGothenburg,visitors’addressMässansgata10.
April22,2015Gothenburg
TheBoard
THIS REPORT HAS NOT BEEN REVIEWED BY THE COMPANY’S AUDITORS.
FINANCIAL REPORTSXVIVOPerfusion’sinterimreportsarepublishedonthecom-pany’swebsite,www.xvivoperfusion.com.
InterimreportApril-June:ThursdayAugust13InterimreportJuly-September:ThursdayOctober23
FOR FURTHER INFORMATION, PLEASE CONTACTMagnusNilsson,CEO,+46317882150, [email protected],CFO,+46317882159, [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 22, 2015 at 8.30 am.
ThisisatranslationoftheSwedishversionofthereport.Whenindoubt,theSwedishwordingprevails.
7InterimreportJanuary–March2015XVIVOPerfusionAB,org.nr.556561-0424
CONSOLIDATED BALANCE SHEETS SEKTHOUSANDS March31,2015 March31,2014 Dec31,2014ASSETSGoodwill 2 006 2808 2 206Otherintangiblefixedassets 95698 89820 97135Tangiblefixedassets 2809 847 1 124Financialfixedassets 7668 6832 8094Inventories 26938 16407 26189Accountsreceivable 22 112 7249 12194Othercurrentreceivables 5 402 5325 6 556Liquidfunds 39663 2127 48203Total assets 202 296 131 415 201 701
SHAREHOLDERS' EQUITY AND LIABILITIESShareholders’equity,attributabletotheParentCompany’sshareholders 179767 98334 176183Provisions 6882 5394 6760Accountspayable 5839 5 614 6468Overdraft 0 11811 0Currenttaxliabilities 2218 3452 3531Othershort-termliabilities 602 549 1129Accruedexpensesandprepaidincome 6988 6 261 7630Total shareholders’ equity and liabilities 202 296 131 415 201 701
Pledgedassetsforownliabilities 23525 18132 23426Contingentliabilities - - -
CONSOLIDATED INCOME STATEMENTSJanuary - March Wholeyear
SEKTHOUSANDS 2015 2014 2014Netsales 31820 18258 84702Costofgoodssold -12305 -4382 -20 656Gross income 19 515 13 876 64 046
Sellingexpenses -7372 -4976 -22669Administrativeexpenses -3240 -2 550 -11 102Researchanddevelopmentcosts -8462 -3573 -23921Otheroperatingrevenuesandexpenses -456 -39 334Operating income -15 2 738 6 688
Financialincomeandexpenses 55 -93 28Income after financial items 40 2 645 6 716
Taxes -1 062 -824 -2978Net income -1 022 1 821 3 738
Attributable toParentCompany’sshareholders -1 022 1821 3738
Earningspershare,SEK -0,05 0,09 0,18Earningspershare,SEK* -0,05 0,09 0,18Averagenumberofoutstandingshares 21512769 19562769 20537769Averagenumberofoutstandingshares* 21707769 19757769 20732769Numberofsharesatclosingday 21512769 19562769 21512769Numberofsharesatclosingday* 21707769 19757769 21707769
EBITDA 2 827 3 106 11 414Amortization -2746 -303 -4 466Depreciation -96 -65 -260Operating income -15 2 738 6 688
*Afterdilution.Seenote2forinformationonwarrantprograms.
8InterimreportJanuary–March2015XVIVOPerfusionAB,org.nr.556561-0424
CONSOLIDATEDKEYRATIOSJanuary - March Wholeyear
SEKTHOUSANDS 2015 2014 2014GrossMarginnonCapitalgoods,% 76 76 77Grossmargin,% 61 76 76OperatingmarginbeforeR&Dcosts,% 27 35 36EBITDAportionofnetsalesnonCapitalgoods,% 11 17 14EBITDA,% 9 17 13Operatingmargin,% 0 15 8Netmargin,% -3 10 4Equity/assetsratio,% 89 75 87Returnonequity,% -1 2 3Incomepershare,SEK -0,05 0,09 0,18Shareholders’equitypershare,SEK 8,36 5,03 8,19Sharepriceonclosingday,SEK 42,70 39,00 34,30
CONSOLIDATED CASH FLOW STATEMENTSJanuary - March Wholeyear
SEKTHOUSANDS 2015 2014 2014Incomeafterfinancialitems 40 2 645 6716Adjustmentforitemsnotaffectingcashflow 2850 367 4 664Paidtaxes -520 -2 610 -4590Changeininventories 1380 1584 -5481Changeintradereceivables -8336 -1755 -6797Changeintradepayables -1345 -3580 1747Cash flow from operating activities -5 931 -3 349 -3 741Cashflowfrominvestingactivities -2994 -3808 -15361Cashflowfromfinancingactivities 0 5 152 62697Cash flow for the period -8 925 -2 005 43 595
Liquidfundsatbeginningofperiod 48203 4131 4131Exchangeratedifferenceinliquidfunds 385 1 477Liquid funds at end of period 39 663 2 127 48 203
CONSOLIDATED CHANGES IN SHAREHOLDERS' EQUITY
AttributabletoParentCompany'sshareholders
SEKTHOUSANDS
Share capital Reserves
Other paidin capital
Retained earningsincl.
profit for the year
Sum shareholders'
equityOpening balance January 1, 2013 500 6 446 84 268 5 421 96 635Totalnetincome 3738 3738Taxallocationreserve 3120 -3120 0Sharewarrantprogram 216 216Newissueofsharesinregistration 50 69139 69189Changeincurrencydiff.subsidiary 6 405 6 405Closing balance December 31, 2013 550 9 566 153 623 12 444 176 183
Opening balance January 1, 2015 550 9 566 153 623 12 444 176 183Totalnetincome -1 022 -1 022Changeincurrencydiff.subsidiary 4 606 4 606Closing balance March 31, 2015 550 9 566 153 623 16 028 179 767
9InterimreportJanuary–March2015XVIVOPerfusionAB,org.nr.556561-0424
INCOME STATEMENTS FOR THE PARENT COMPANYJanuary - March Wholeyear
SEKTHOUSANDS 2015 2014 2014Netsales 16853 27020 80845Costofgoodssold -5 524 -3752 -17256Gross income 11 329 23 268 63 589
Sellingexpenses -4 161 -3556 -15801Administrativeexpenses -2364 -1980 -8932Researchanddevelopmentcosts -7912 -3373 -23149Otheroperatingrevenuesandexpenses -460 -39 331Operating income -3 568 14 320 16 038
Financialincomeandexpenses 2 521 -204 3101Incomeafterfinancialitems -1 047 14 116 19 139
Yearenddispositions - - -4 000Taxes - -2841 -3427Net income -1 047 11 275 11 712
DepreciationandamortizationhasreducedincomefortheperiodbySEK2585thousand(139).
CONSOLIDATED INCOME STATEMENTS PER QUARTER
Jan - March Oct - Dec July-Sep April-June Jan - March Oct - Dec July-Sep April-JuneSEKTHOUSANDS 2015 2014 2014 2014 2014 2013 2013 2013Netsales 31820 25543 22427 18474 18258 20032 16784 15777Costofgoodssold -12305 -5937 -6474 -3863 -4382 -4799 -3409 -3327Gross income 19 515 19 606 15 953 14 611 13 876 15 233 13 375 12 450
Sellingexpenses -7372 -5794 -5586 -6313 -4976 -4707 -4352 -4719Administrativeexpenses -3240 -3034 -2495 -3023 -2 550 -3090 -2643 -2942Researchanddevelopmentcosts -8462 -10675 -5 661 -4 012 -3573 -4997 -4513 -2887Otheroperatingrevenuesandexpenses -456 196 52 125 -39 178 825 101Operating income -15 299 2 263 1 388 2 738 2 617 2 692 2 003
Financialincomeandexpenses 55 166 36 -81 -93 345 -512 275Income after financial items 40 465 2 299 1 307 2 645 2 962 2 180 2 278
Taxes -1 062 -777 -822 -555 -824 -598 -604 -565Net income -1 022 -312 1 477 752 1 821 2 364 1 576 1 713
Attributable toParentCompany’sshareholders -1 022 -312 1477 752 1821 2364 1576 1713
Earningspershare,SEK -0,05 -0,01 0,07 0,04 0,09 0,12 0,08 0,09Earningspershare,SEK* -0,05 -0,01 0,07 0,04 0,09 0,12 0,08 0,09Averagenumberofoutstandingshares 21512769 21512769 21512769 19562769 19562769 19562769 19562769 19562769Averagenumberofoutstandingshares* 21707769 21707769 21707769 19757769 19757769 19562769 19562769 19562769Numberofsharesatclosingday 21512769 21512769 21512769 19562769 19562769 19562769 19562769 19562769Numberofsharesatclosingday* 21707769 21707769 21707769 19757769 19757769 19757769 19562769 19562769
EBITDA 2827 3107 3445 1756 3106 2982 3828 2352Amortization -2746 -2744 -1 116 -303 -303 -303 -1073 -297Depreciation -96 -64 -66 -65 -65 -62 -63 -52Operating income -15 299 2 263 1 388 2 738 2 617 2 692 2 003
*Afterdilution.Seenote2forinformationonwarrantprograms.
10 Interim report January – March 2015 XVIVO Perfusion AB, org.nr. 556561-0424
NOTE 1. ACCOUNTING PRINCIPLES
ThisinterimreportwaspreparedpursuanttotheSwedishAnnualAccountsAct.EffectiveJanuary1,2014thecompanyappliesframeworkBFNAR2012-1fromtheSwedishAccountingStandardsBoard(K3).ThetransitiontoK3hashadnoimpactonthefinancialstatements.
NOTE 2. SHARE WARRANT PROGRAMS
Intotalthereare390,000outstandingwarrantsintwoprograms.Ifallthewar-rantsareexercisedtosubscribeforshares,thesharecapitalwillincreasebyaroundSEK10,000andthenumberofshareswillincreaseby390,000sharesintotal,correspondingtodilutionofapproximately1.8percentofthetotalnumberofsharesandvotes.Sharewarrantprogram2013/2015consistsof195,000war-rantsandinJune2015eachwarrantwillentitletheholdertosubscribeforonenewshareatapriceofSEK32.40.Sharewarrantprogram2014/2016consistsof195,000warrantsandinJune2016eachwarrantwillentitletheholdertosubs-cribeforonenewshareatapriceofSEK58.60.
BALANCE SHEETS FOR THE PARENT COMPANY SEKTHOUSANDS March31,2015 March31,2014 Dec31,2014ASSETSBalancedexpendituresfordevelopment 94387 88538 95908Patentsandlicencies 1286 1248 1 202Trademarks 24 29 25Tangiblefixedassets 1910 374 338Participationinaffiliatedcompanies 14475 14475 14475Otherfinancialfixedassets 4197 2882 4099Inventories 12532 3260 7716Accountsreceivable 6995 3281 5431Receivablesfromaffiliatedcompanies 20 501 19700 24737Othercurrentreceivables 5 061 5 202 6334Liquidfunds 37306 882 44 060Totalassets 198 674 139 871 204 325
SHAREHOLDERS' EQUITY AND LIABILITIESShareholders’equity 171700 102902 172745Untaxedreserves 12238 8238 12238Provisions 4190 3581 4068Overdraft - 11811 0Accountspayable 2939 4 062 4 524Liabilitiestoaffiliatedcompanies - - 118Currenttaxliabilities 1 500 3306 3417Othershort-termliabilities 6107 5971 7215Totalshareholders’equityandliabilities 198 674 139 871 204 325
Pledgedassetsforownliabilities 23525 18132 23426Contingentliabilities - - -
11 Interim report January – March 2015 XVIVO Perfusion AB, org.nr. 556561-0424
PRODUCT NAME SALES TYPE SALES AREA XPS™ DurableGoods Machinefor Varm Perfusion
STEEN Solution™ Warm Perfusion
XPS Disposable Lung Warm Perfusion Perfusion Circuit™
XPS Disposable Lung Kit™ Warm Perfusion
XVIVO Organ Chamber™ Warm Perfusion
XPS PGM Warm Perfusion Disposable Sensors™
Perfadex® Cold Preservation
Silicone Tubing Set Cold Preservation
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