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1NEWSRELEASENASDAQ:NVCNTSX:NVCNeovascAnnouncesResultsfortheFourthQuarterandFiscalYear2015Vancouver,BC,Canada–March29,2016–NeovascInc.
("Neovasc"orthe"Company")(NASDAQ:NVCN)(TSX:NVC)todayannouncedfinancialresultsfortheyearendedDecember31,2015.
Ofnote,theCompany'sfinancialresultsarenowbeingpresentedinU.
S.
dollars.
"Ourchiefpriorityfor2016istocompleteallthenecessaryregulatoryandclinicalactivitytobeginaCEMarktrialforTiara,whilecontinuingtoexpandReducer'scommercialfootprintinEurope,"commentedNeovascCEO,AlexeiMarko.
"2016willbeourfirstfullyearofcommercialsalesforReducer,andwithdistributorsnowinmultipleEuropeancountriesincludingItalyandGermany,weexpectthisbaseofbusinesstogrow,"saidChrisClark,CFOofNeovasc.
"Aswecontinuetransitioningrevenuefromourlegacybusinessestoourownproprietaryproducts,ourbalancesheetremainsverystrong,entering2016withmorethan$55millionincash.
"Subsequenttoyearend,theCompanyreceivedFDAapprovaltoincludethe40mmTiaravalveintheTIARA-IEarlyFeasibilityTrial,andnowhasfourU.
S.
hospitalsapprovedtobeginscreeningpatientsforthissizeddevice.
TheCompanybelievesthe40mmvalveandotherinitiativeswillresultinsteadypatientenrolmentinthetrialandrelatedearlyfeasibilityclinicalactivities.
Managementwillupdatethetrial'sprogressandprovideabroaderclinicalupdateforbothitsTiaraandtheNeovascReduceratupcomingmedicalconferences.
NeovasctochangepresentationcurrencytoUSdollarsTheCompanyhaselectedtoadopttheU.
S.
dollarasitspresentationcurrencytobetterreflectitsbusinessandtoimprovecomparabilityofitsfinancialinformationwithotherpubliclytradedbusinessesinthelifesciencesindustry.
ThischangeiseffectivefortheyearendedDecember31,2015andallcomparativefinancialinformationcontainedhereinhasbeenrecasttoreflecttheCompany'sresultsasiftheyhadbeenhistoricallyreportedinU.
S.
dollars.
TheCompanypreparesitsconsolidatedfinancialstatementsinaccordancewithInternationalFinancialReportingStandards,asissuedbytheInternationalAccountingStandardsBoard.
ResultsforthequartersendedDecember31,2015and2014RevenuesRevenuesforthequarterendedDecember31,2015were$2,224,046comparedto$2,953,039forthesameperiodin2014.
Reducerrevenuesincreasedto$192,013forthequarter,representinga20%increasefromthequarterendedSeptember30,2015.
TheCompanyinitiateditsfocusedcommercializationofReducerinEuropeinthefirstquarterof2015.
Contractmanufacturingrevenueswerecomparabletothepriorperiodandconsultingservicesdeclinedby$670,422or39%,whichisconsistentwiththeyear-over-yeardeclineandconsistentwiththeCompany'sstrategytofocusitsbusinesstowardsdevelopmentandcommercializationofitsownproducts,theReducerandTiara.
2CostofGoodsSoldThecostofgoodssoldforthequarterendedDecember31,2015was$1,942,140,comparedto$2,344,816forthesameperiodin2014.
ThegrossmarginforthequarterendedDecember31,2015was13%,comparedto21%forthesameperiodin2014.
Historically,marginshavebeenlowerinthefourthquarterthanotherperiods.
Inaddition,in2015,weissuedacreditnotetoasinglecustomer,whichreducedmarginsfrom23%to13%forthefourthquarterof2015.
ExpensesTotalexpensesforthequarterendedDecember31,2015were$8,352,093,comparedto$7,363,045forthesameperiodin2014,anincreaseof13%.
Theincreaseissubstantiallyduetoanincreaseof$683,674ingeneralandadministrativeexpensesandanincreaseof$112,266inclinicaltrialandproductdevelopmentexpensesfortheCompany'stwonewproductdevelopmentprograms.
Sellingexpenseswere$292,456forthequarterendedDecember31,2015,comparedto$99,348forthesameperiodin2014,anincreaseof194%astheCompanycommercializesReducerinEurope.
Generalandadministrativeexpenseswere$3,498,682forthequarterendedDecember31,2015,comparedto$2,815,008inthesameperiodin2014,representinganincreaseof24%.
Theincreaseingeneralandadministrativeexpenseswasprincipallyduetoa$1,502,911increaseinlitigationexpenses.
Theincreaseinresearchanddevelopmentcosts,includingproductdevelopmentandclinicaltrialexpensesisprincipallyduetoincreasedinvestmentintheTiaradevelopmentprogram.
LossesThenetlossforthequarterendedDecember31,2015was$7,383,608,or$0.
11basicanddilutedlosspershare,comparedwithalossof$6,710,674,or$0.
12basicanddilutedlosspershareforthesameperiodin2014.
ResultsfortheyearsendedDecember31,2015and2014RevenuesRevenuesdecreased31%year-over-yearto$9,929,940fortheyearendedDecember31,2015,comparedtorevenuesof$14,370,667forthesameperiodin2014.
ThisdeclineisinlinewiththeCompany'sexpectationsandconsistentwithitsstrategytodrivedevelopmentandcommercializationofTiaraandReducer.
ReducersalesfortheyearendedDecember31,2015were$526,412,comparedto$nilforthesameperiodin2014.
Includedwithintheserevenuesarestockingordersfromnewterritoriesandre-ordersfromcertainterritoriesinEurope.
ContractmanufacturingrevenuesfortheyearendedDecember31,2015were$3,236,978,comparedto$3,033,976forthesameperiodin2014,representinganincreaseof7%.
TheincreaseinrevenuefortheyearendedDecember31,2015comparedtothesameperiodin2014isprimarilyduetogrowingrevenuesfromasinglecustomer.
TheCompanyhasseenaconcentrationofrevenueintofewerlargeraccountsandexpectsthatthisreflectsgrowingdemandforthosecustomers'products.
Neovascanticipatesthatcontractmanufacturingwillcontinuetogrowinthelongtermasitscustomers'productsreceiveregulatoryapprovalsandarecommercialized,butrecognizesthattheserevenueswillbederivedfromasmallercustomerbaseasthetranscatheteraorticvalvemarketmatures.
RevenuesfromconsultingservicesfortheyearendedDecember31,2015were$5,812,814,comparedto$9,282,649forthesameperiodin2014,representingadecreaseof37%.
ThelossofasinglecontractaccountsforthemajorityofthisdeclineandisindicativeofthetrendtheCompanyisseeinginconsultingservicerevenue.
TheCompanyanticipatesthatitsconsultingservicesrevenuewilldeclineinthelongtermasitsconsultingcustomerscontinuetotransitiontobecomingcontractmanufacturingcustomers.
3ProductsalesfortheyearendedDecember31,2015were$353,736,comparedto$2,054,042forthesameperiodin2014,representingadecreaseof83%.
ProductsalesaresolelycomprisedofsalesofsurgicalpatchestoLeMaitreVascular,Inc.
NeovascceasedmanufacturingsurgicalpatchesforLeMaitreinJune2015.
CostofGoodsSoldThecostofgoodssoldfortheyearendedDecember31,2015was$6,938,134,comparedto$9,146,371forthesameperiodsin2014.
TheoverallgrossmarginfortheyearendedDecember31,2015was30%,comparedto36%grossmarginforthesameperiodin2014.
TheCompanylostasignificanthighermargincontractmanufacturingaccounttowardtheendof2014andhasseenduringtheyearitsconsultingservicesrevenuemarginsdeclineasitsabilitytochargehigherfeesfortheseserviceshasdecreasedasthetranscatheteraorticvalvemarkethasmatured.
Inaddition,theCompanyisexperiencinghighercostofgoodssoldasitsqualitysystemhasbeenimprovedtomeettheexpectationsofrapidlymaturingcustomers.
Theseincreasesarenotproductiveimprovementsandresultinanoveralldownwardtrendinmargins.
ExpensesTotalexpensesfortheyearendedDecember31,2015were$31,750,140,comparedto$22,494,468forthesameperiodin2014,representinganincreaseof$9,255,672or41%.
TheincreaseintotalexpensesfortheyearendedDecember31,2015comparedtothesameperiodin2014reflectsa$498,279increaseinsellingexpensesastheCompanycommercializesReducer,a$3,187,418increaseingeneralandadministrativeexpenses(ofwhich$6,223,938relatestoanincreaseinlitigationexpenses)anda$5,569,975increaseinproductdevelopmentandclinicaltrialexpensestoadvancetheTiaraandReducerdevelopmentprograms.
SellingexpensesfortheyearendedDecember31,2015were$655,669,comparedto$157,390forthesameperiodin2014,representinganincreaseof$498,279,or317%.
TheincreaseinsellingexpensesfortheyearendedDecember31,2015comparedtothesameperiodin2014reflectscostsincurredforReducercommercializationactivitiesin2015.
TheCompanyanticipatesasignificantincreaseinsellingexpensesin2016asitcontinuesitscommercializationoftheReducerinselectcountriesinEurope.
GeneralandadministrativeexpensesfortheyearendedDecember31,2015were$13,913,076,comparedto$10,725,658forthesameperiodin2014,representinganincreaseof$3,187,418,or30%.
TheincreaseingeneralandadministrativeexpensesfortheyearendedDecember31,2015comparedtothesameperiodin2014canbesubstantiallyexplainedbya$6,223,938increaseinlitigationexpensesanda$703,989increaseincash-basedemployeeexpenses,offsetbya$3,480,148decreaseinshare-basedpayments.
In2015theCompanyadjusteditscompensationplantodirectors,officersandseniormanagement,decreasingthenumberofoptionsgrantedby75%,replacingtheseoptionswithasmallercashbasedbonusplanandincreasingofficersandseniormanagement'sbasesalariesby10%.
Othercashbasedemployeeexpensesarerelatedtoadditionalheadcountinquality,financeandhumanresourcedepartmentsandwithotheremployeeexpenses.
ProductdevelopmentandclinicaltrialexpensesfortheyearendedDecember31,2015were$17,181,395,comparedto$11,611,420forthesameperiodin2014,representinganincreaseof$5,569,975,or48%.
TheincreaseinproductdevelopmentandclinicaltrialexpensesfortheyearendedDecember31,2015wasduetoa$1,943,414increaseincash–basedemployeeexpensesastheCompanyhiredadditionalstafftoadvanceproductdevelopment,a$4,707,064increaseinotherexpensesastheCompanyinvestedinitstwomajornewproductinitiatives,offsetbya$1,198,786decreaseinshare-basedpayments.
TheCompany'sexpensesaresubjecttoinflationandcostincreases.
Salariesandwageshaveincreasedonaverageby6%intheyearendedDecember31,2015comparedtothesameperiodin2014.
TheCompany4hasnotseenamaterialincreaseinthepriceofanyofthecomponentsusedinthemanufactureofitsproductsandservices.
OtherIncomeTheotherincomefortheyearendedDecember31,2015was$2,195,195,comparedto$94,427forthesameperiodin2014.
TheCompany'sinvestmentsinhighinterestsavingsaccountsandguaranteedinvestmentcertificatesgenerated$577,006interestduringtheyearendedDecember31,2015.
TheCompanybenefitedfromsignificantforeignexchangegainsonitsforeigncurrency-denominatedcashandcashequivalentsandaccountsreceivableduringtheyearendedDecember31,2015of$1,620,727.
LossesTheoperatinglossesandcomprehensivelossesfortheyearendedDecember31,2015were$26,730,490and$35,116,695respectively,or$0.
41basicanddilutedlosspershare,ascomparedwithlossesof$17,175,745and$18,154,725,or$0.
33basicanddilutedlosspershareforthesameperiodin2014.
The$9,554,745increaseintheoperatinglossincurredfortheyearendedDecember31,2015comparedtothesameperiodin2014canbesubstantiallyexplainedbya$2,232,490decreaseingrossprofit,a$3,187,418increaseingeneralandadministrativeexpenses(ofwhich$6,223,938relatestoanincreaseinlitigationexpenses),a$5,569,975increaseinproductdevelopmentandclinicaltrialexpenses,andoffsetbya$2,100,768increaseinotherincome.
LitigationexpensesfortheyearendedDecember31,2015representalossof$0.
11basicanddilutedlosspersharecomparedtoalossof$0.
02basicanddilutedlosspershareforthesameperiodin2014.
TheCompanyhasincurredsignificantcostsindefendingitselfinlawsuitsfiledbyCardiAQValveTechnologies,Inc.
TotallitigationcostssincetheinitialclaimswerefiledinJune2014areapproximately$7.
89millionandtheCompanymayrequireanadditional$7.
5milliontocoveradditionallitigationexpensesuptoandincludingthetrial,scheduledforMay2016.
DiscussionofLiquidityandCapitalResourcesNeovascfinancesitsoperationsandcapitalexpenditureswithcashgeneratedfromoperations,linesofcreditandequityfinancings.
AtDecember31,2015,theCompanyhadcashandcashequivalentsof$55,026,171comparedtocashandcashequivalentsof$5,193,561andshortterminvestmentsof$10,343,999atDecember31,2014.
CashusedinoperatingactivitiesfortheyearendedDecember31,2015,was$21,282,958,comparedto$8,063,446forthesameperiodin2014.
FortheyearendedDecember31,2015,operatingexpenseswere$22,693,678,comparedto$8,202,450forthesameperiodin2014,cashexpendituresonlitigation(litigationexpenseslesschangeinaccountspayablerelatedtolitigation)wereapproximately$6.
0millionandcashexpendituresonresearchanddevelopmentandclinicaltrials(expenseslesssharebasedpaymentsanddepreciation)wereapproximately$6.
6million.
Workingcapitalitemsgeneratedcashof$821,165,comparedto$39,960forthesameperiodin2014,asaccountsreceivableabsorbedcashdueatyearendduetoalatepaymentreceivedimmediatelyaftertheyearend,inventoryabsorbedcashprincipallyinthedevelopmentofreasonableworkingquantitiesofReducerinventory,prepaidexpensesandotherassetsgeneratedcashduetodecreasedprepaymentandaccountspayablepreservedcashatyearendduetosignificantlitigationexpensesincurredbutnotpaidforofapproximately$1.
1millionasatDecember31,2015.
OutstandingShareDataAsatMarch29,2016,theCompanyhad66,837,345commonvotingsharesissuedandoutstanding.
Further,thefollowingsecuritiesareconvertibleintocommonsharesoftheCompany:8,171,966stockoptionswithaweightedaveragepriceofCDN$3.
96.
ThefullydilutedsharecapitaloftheCompanyatMarch29,2016is75,008,711.
Neovasc's2015FinancialStatementsandNotes,itsManagement'sDiscussionandAnalysis,itsAnnualInformationFormanditsForm40-FwillbepostedontheCompany'swebsiteatwww.
neovasc.
comandwillbe5filedonSEDARandEDGAR.
Inadditiontothesummarycontainedherein,readersareencouragedtoreviewthefulldisclosureinNeovasc'sFinancialStatementsforthetwelvemonthsendingDecember31,2015andManagement'sDiscussionandAnalysis.
ConferenceCallandWebcastInformationNeovascwillbehostingaconferencecalltodayat4:30pmETtodiscusstheseresults.
Toparticipateintheconference,dial8883900549or4167648682.
Arecordingofthecallwillbeavailablefor72hoursbycalling8883900541or4167648677andusingpasscode825521#.
AlinktotheliveandarchivedaudiowebcastoftheconferencecallwillalsobeavailableonthePresentationsandEventspageoftheInvestorssectionofNeovasc'swebsiteatwww.
neovasc.
com.
ConsolidatedStatementsofFinancialPositionAsatDecember31,(ExpressedinUnitedStatesdollars)20152014ASSETSCurrentassetsCashandcashequivalents$55,026,171$5,193,561Investments-10,343,999Accountsreceivable1,736,9411,543,817Inventory598,136410,290Prepaidexpensesandotherassets146,590223,483Totalcurrentassets57,507,83817,715,150Non-currentassetsProperty,plantandequipment3,720,5562,653,271Totalnon-currentassets3,720,5562,653,271Totalassets$61,228,394$20,368,421LIABILITIESANDEQUITYLiabilitiesCurrentliabilitiesAccountspayableandaccruedliabilities$3,232,971$2,166,268Currentportionoflong-termdebt-38,437Totalcurrentliabilities3,232,9712,204,705Non-currentliabilitiesLong-termdebt-135,875Totalnon-currentliabilities-135,875Totalliabilities3,232,9712,340,580EquitySharecapital161,505,03789,357,061Contributedsurplus20,569,11017,632,809Accumulatedothercomprehensiveloss(8,790,011)(403,806)Deficit(115,288,713)(88,558,223)Totalequity57,995,42318,027,841Totalliabilitiesandequity$61,228,394$20,368,4216ConsolidatedStatementsofLossandComprehensiveLossFortheyearsendedDecember31,(ExpressedinUnitedStatesdollars)20152014REVENUEReducer$526,412$-Productsales353,7362,054,042Contractmanufacturing3,236,9783,033,976Consultingservices5,812,8149,282,6499,929,94014,370,667COSTOFGOODSSOLD6,938,1349,146,371GROSSPROFIT2,991,8065,224,296EXPENSESSellingexpenses655,669157,390Generalandadministrativeexpenses13,913,07610,725,658Productdevelopmentandclinicaltrialsexpenses17,181,39511,611,42031,750,14022,494,468OPERATINGLOSS(28,758,334)(17,270,172)OTHERINCOME/(EXPENSE)Interestincome577,006198,677Interestexpense(2,538)(6,991)Lossondisposalofpropertyandequipment-(29,406)Gain/(Loss)onforeignexchange1,620,727(67,853)2,195,19594,427LOSSBEFORETAX(26,563,139)(17,175,745)Taxexpense(167,351)-LOSSFORTHEYEAR$(26,730,490)$(17,175,745)OTHERCOMPREHENSIVELOSSFORTHEYEARExchangedifferenceontranslation(8,386,205)(978,980)LOSSANDCOMPREHENSIVELOSSFORTHEYEAR$(35,116,695)$(18,154,725)LOSSPERSHAREBasicanddilutedlosspershare$(0.
41)$(0.
33)7ConsolidatedStatementsofCashFlowsFortheyearsendedDecember31,(ExpressedinUnitedStatesdollars)20152014OPERATINGACTIVITIESLossfortheyear$(26,730,490)$(17,175,745)Adjustmentsfor:Depreciation503,709339,372Share-basedpayments4,114,1658,603,791Lossondisposaloffixedassets-29,406Write-downaccountsreceivable25,893192,412Interestincome(609,493)(198,677)Interestexpense2,5386,991(22,693,678)(8,202,450)Netchangeinnon-cashworkingcapitalitems:Accountsreceivable(468,478)(574,042)Inventory(269,605)3,334Prepaidexpensesandotherassets31,592(210,530)Accountspayableandaccruedliabilities1,527,656821,198821,16539,960Interestpaidandreceived:Interestreceived592,093106,035Interestpaid(2,538)(6,991)589,55599,044Netcashappliedtooperatingactivities(21,282,958)(8,063,446)INVESTINGACTIVITESRedemptionof/(Investmentin)guaranteedinvestmentcertificates9,322,492(10,900,599)Purchaseofproperty,plantandequipment(2,143,128)(1,120,345)Netcashfrom/(appliedto)investingactivities7,179,364(12,020,944)FINANCINGACTIVITIESRepaymentoflong-termdebt(164,364)(37,456)Proceedsfromshareissuepursuanttoanunderwrittenpublicoffering,netofshareissuecosts69,879,21022,116,736Proceedsfromexerciseofoptions1,090,092175,679Netcashfromfinancingactivities70,804,93822,254,959NETCHANGEINCASHANDCASHEQUIVALENTS56,701,3442,170,569CASHANDCASHEQUIVALENTSBeginningoftheyear5,193,5613,199,944Exchangedifferenceoncashandcashequivalents(6,868,734)(176,952)Endoftheyear$55,026,171$5,193,561Representedby:Cash7,860,728784,461Cashablehighinterestsavingsaccounts25,490,4434,409,100Cashableguaranteedinvestmentcertificates21,675,000-$55,026,171$5,193,5618AboutNeovascInc.
Neovascisaspecialtymedicaldevicecompanythatdevelops,manufacturesandmarketsproductsfortherapidlygrowingcardiovascularmarketplace.
ItsproductsindevelopmentincludetheTiara,forthetranscathetertreatmentofmitralvalvediseaseandtheNeovascReducerforthetreatmentofrefractoryangina.
TheCompanyalsosellsalineofadvancedbiologicaltissueproductsthatareusedaskeycomponentsinthird-partymedicalproductsincludingtranscatheterheartvalves.
Formoreinformation,visit:www.
neovasc.
com.
Thisnewsreleasecontainsforward-lookingstatementswithinthemeaningoftheU.
S.
PrivateSecuritiesLitigationReformActof1995andapplicableCanadiansecuritieslawsrelatingtotheCompany'spriorityin2016tocompleteallnecessaryregulatoryandclinicalactivitytobeginaCEMarktrialforTiara;theCompany'sstrategytorefocusitsbusinesstowardsdevelopmentandcommercializationoftheNeovascReducerandTiara;thelikelihoodofsteadyoracceleratedpatientenrolmentintheTIARA-IEarlyFeasibilityTrial;theanticipatedgrowthofcontractingmanufacturinginthelong-termbasedongrowthofdemandforourcustomers'products;thematurationofthetranscatheteraorticvalvemarket;theanticipatedgrowthoftheCompany'sbaseofbusinessinEurope;theexpecteddeclineofconsultingservicesrevenueinthelongtermastheCompany'sconsultingcustomersbecomecontractmanufacturingcustomers;theexpectedincreaseofsellingexpensesin2016astheCompanycontinuescommercializationoftheNeovascReducer;andtheamountofestimatedadditionallitigationexpensesrequiredtodefendtheCompanyinlawsuitsfiledbyCardiaqValveTechnologies,Inc.
Thewords"expect","anticipate","may","will","intend,"and"believe"areintendedtoidentifyforward-lookingstatements.
Forward-lookingstatementsarebasedonestimatesandassumptionsmadebytheCompanyinlightofitsexperienceanditsperceptionofhistoricaltrends,currentconditionsandexpectedfuturedevelopments,aswellasotherfactorsthattheCompanybelievesareappropriateinthecircumstances.
ManyfactorsandassumptionscouldcausetheCompany'sactualresults,performanceorachievementstodiffermateriallyfromthoseexpressedorimpliedbytheforward-lookingstatements,including,withoutlimitation,theconductorpossibleoutcomesofanyactualorthreatenedlegalproceedings,whichareinherentlyuncertain;thepotentialbenefitsoftheNeovascReducerandTiaraascomparedwithotherproducts;successfulenrollmentofpatientsinstudiesandtrialsfortheNeovascReducerandTiara;resultsofthetrialsandstudiesfortheNeovascReducerandTiarathatmeettheCompany'sexpectations;theCompany'sreceiptofanyrequiredlocalandinstitutionalregulatoryapprovalsandthetimingandcostsofobtainingsuchapprovals;Europeanenrollmentinourclinicaltrials,studiesandcompassionateusecasesandthesuccessofapplicationsinEurope;theCompany'sabilitytoprotectitsintellectualproperty;theCompany'sabilitytoraiseadditionalfunding;changesinbusinessstrategyordevelopmentplans;existinggovernmentalregulationsandchangesin,orthefailuretocomplywith,governmentalregulationsandgeneraleconomicandbusinessconditions,bothnationallyandintheregionsinwhichtheCompanyoperates.
TheseriskfactorsandothersrelatingtotheCompanyarediscussedingreaterdetailinthe"RiskFactors"sectionoftheCompany'sAnnualInformationForm,whichisincludedinitsAnnualReportonForm40-F(copiesofwhichfilingsmaybeobtainedatwww.
sedar.
comorwww.
sec.
gov).
Thesefactorsshouldbeconsideredcarefully,andreadersshouldnotplaceunduerelianceontheCompany'sforward-lookingstatements.
TheCompanyhasnointentionandundertakesnoobligationtoupdateorreviseanyforward-lookingstatements,whetherasaresultofnewinformation,futureeventsorotherwise,exceptasrequiredbylaw.
###InvestorRelationsNeovascInc.
ChrisClark604248-4138cclark@neovasc.
com
("Neovasc"orthe"Company")(NASDAQ:NVCN)(TSX:NVC)todayannouncedfinancialresultsfortheyearendedDecember31,2015.
Ofnote,theCompany'sfinancialresultsarenowbeingpresentedinU.
S.
dollars.
"Ourchiefpriorityfor2016istocompleteallthenecessaryregulatoryandclinicalactivitytobeginaCEMarktrialforTiara,whilecontinuingtoexpandReducer'scommercialfootprintinEurope,"commentedNeovascCEO,AlexeiMarko.
"2016willbeourfirstfullyearofcommercialsalesforReducer,andwithdistributorsnowinmultipleEuropeancountriesincludingItalyandGermany,weexpectthisbaseofbusinesstogrow,"saidChrisClark,CFOofNeovasc.
"Aswecontinuetransitioningrevenuefromourlegacybusinessestoourownproprietaryproducts,ourbalancesheetremainsverystrong,entering2016withmorethan$55millionincash.
"Subsequenttoyearend,theCompanyreceivedFDAapprovaltoincludethe40mmTiaravalveintheTIARA-IEarlyFeasibilityTrial,andnowhasfourU.
S.
hospitalsapprovedtobeginscreeningpatientsforthissizeddevice.
TheCompanybelievesthe40mmvalveandotherinitiativeswillresultinsteadypatientenrolmentinthetrialandrelatedearlyfeasibilityclinicalactivities.
Managementwillupdatethetrial'sprogressandprovideabroaderclinicalupdateforbothitsTiaraandtheNeovascReduceratupcomingmedicalconferences.
NeovasctochangepresentationcurrencytoUSdollarsTheCompanyhaselectedtoadopttheU.
S.
dollarasitspresentationcurrencytobetterreflectitsbusinessandtoimprovecomparabilityofitsfinancialinformationwithotherpubliclytradedbusinessesinthelifesciencesindustry.
ThischangeiseffectivefortheyearendedDecember31,2015andallcomparativefinancialinformationcontainedhereinhasbeenrecasttoreflecttheCompany'sresultsasiftheyhadbeenhistoricallyreportedinU.
S.
dollars.
TheCompanypreparesitsconsolidatedfinancialstatementsinaccordancewithInternationalFinancialReportingStandards,asissuedbytheInternationalAccountingStandardsBoard.
ResultsforthequartersendedDecember31,2015and2014RevenuesRevenuesforthequarterendedDecember31,2015were$2,224,046comparedto$2,953,039forthesameperiodin2014.
Reducerrevenuesincreasedto$192,013forthequarter,representinga20%increasefromthequarterendedSeptember30,2015.
TheCompanyinitiateditsfocusedcommercializationofReducerinEuropeinthefirstquarterof2015.
Contractmanufacturingrevenueswerecomparabletothepriorperiodandconsultingservicesdeclinedby$670,422or39%,whichisconsistentwiththeyear-over-yeardeclineandconsistentwiththeCompany'sstrategytofocusitsbusinesstowardsdevelopmentandcommercializationofitsownproducts,theReducerandTiara.
2CostofGoodsSoldThecostofgoodssoldforthequarterendedDecember31,2015was$1,942,140,comparedto$2,344,816forthesameperiodin2014.
ThegrossmarginforthequarterendedDecember31,2015was13%,comparedto21%forthesameperiodin2014.
Historically,marginshavebeenlowerinthefourthquarterthanotherperiods.
Inaddition,in2015,weissuedacreditnotetoasinglecustomer,whichreducedmarginsfrom23%to13%forthefourthquarterof2015.
ExpensesTotalexpensesforthequarterendedDecember31,2015were$8,352,093,comparedto$7,363,045forthesameperiodin2014,anincreaseof13%.
Theincreaseissubstantiallyduetoanincreaseof$683,674ingeneralandadministrativeexpensesandanincreaseof$112,266inclinicaltrialandproductdevelopmentexpensesfortheCompany'stwonewproductdevelopmentprograms.
Sellingexpenseswere$292,456forthequarterendedDecember31,2015,comparedto$99,348forthesameperiodin2014,anincreaseof194%astheCompanycommercializesReducerinEurope.
Generalandadministrativeexpenseswere$3,498,682forthequarterendedDecember31,2015,comparedto$2,815,008inthesameperiodin2014,representinganincreaseof24%.
Theincreaseingeneralandadministrativeexpenseswasprincipallyduetoa$1,502,911increaseinlitigationexpenses.
Theincreaseinresearchanddevelopmentcosts,includingproductdevelopmentandclinicaltrialexpensesisprincipallyduetoincreasedinvestmentintheTiaradevelopmentprogram.
LossesThenetlossforthequarterendedDecember31,2015was$7,383,608,or$0.
11basicanddilutedlosspershare,comparedwithalossof$6,710,674,or$0.
12basicanddilutedlosspershareforthesameperiodin2014.
ResultsfortheyearsendedDecember31,2015and2014RevenuesRevenuesdecreased31%year-over-yearto$9,929,940fortheyearendedDecember31,2015,comparedtorevenuesof$14,370,667forthesameperiodin2014.
ThisdeclineisinlinewiththeCompany'sexpectationsandconsistentwithitsstrategytodrivedevelopmentandcommercializationofTiaraandReducer.
ReducersalesfortheyearendedDecember31,2015were$526,412,comparedto$nilforthesameperiodin2014.
Includedwithintheserevenuesarestockingordersfromnewterritoriesandre-ordersfromcertainterritoriesinEurope.
ContractmanufacturingrevenuesfortheyearendedDecember31,2015were$3,236,978,comparedto$3,033,976forthesameperiodin2014,representinganincreaseof7%.
TheincreaseinrevenuefortheyearendedDecember31,2015comparedtothesameperiodin2014isprimarilyduetogrowingrevenuesfromasinglecustomer.
TheCompanyhasseenaconcentrationofrevenueintofewerlargeraccountsandexpectsthatthisreflectsgrowingdemandforthosecustomers'products.
Neovascanticipatesthatcontractmanufacturingwillcontinuetogrowinthelongtermasitscustomers'productsreceiveregulatoryapprovalsandarecommercialized,butrecognizesthattheserevenueswillbederivedfromasmallercustomerbaseasthetranscatheteraorticvalvemarketmatures.
RevenuesfromconsultingservicesfortheyearendedDecember31,2015were$5,812,814,comparedto$9,282,649forthesameperiodin2014,representingadecreaseof37%.
ThelossofasinglecontractaccountsforthemajorityofthisdeclineandisindicativeofthetrendtheCompanyisseeinginconsultingservicerevenue.
TheCompanyanticipatesthatitsconsultingservicesrevenuewilldeclineinthelongtermasitsconsultingcustomerscontinuetotransitiontobecomingcontractmanufacturingcustomers.
3ProductsalesfortheyearendedDecember31,2015were$353,736,comparedto$2,054,042forthesameperiodin2014,representingadecreaseof83%.
ProductsalesaresolelycomprisedofsalesofsurgicalpatchestoLeMaitreVascular,Inc.
NeovascceasedmanufacturingsurgicalpatchesforLeMaitreinJune2015.
CostofGoodsSoldThecostofgoodssoldfortheyearendedDecember31,2015was$6,938,134,comparedto$9,146,371forthesameperiodsin2014.
TheoverallgrossmarginfortheyearendedDecember31,2015was30%,comparedto36%grossmarginforthesameperiodin2014.
TheCompanylostasignificanthighermargincontractmanufacturingaccounttowardtheendof2014andhasseenduringtheyearitsconsultingservicesrevenuemarginsdeclineasitsabilitytochargehigherfeesfortheseserviceshasdecreasedasthetranscatheteraorticvalvemarkethasmatured.
Inaddition,theCompanyisexperiencinghighercostofgoodssoldasitsqualitysystemhasbeenimprovedtomeettheexpectationsofrapidlymaturingcustomers.
Theseincreasesarenotproductiveimprovementsandresultinanoveralldownwardtrendinmargins.
ExpensesTotalexpensesfortheyearendedDecember31,2015were$31,750,140,comparedto$22,494,468forthesameperiodin2014,representinganincreaseof$9,255,672or41%.
TheincreaseintotalexpensesfortheyearendedDecember31,2015comparedtothesameperiodin2014reflectsa$498,279increaseinsellingexpensesastheCompanycommercializesReducer,a$3,187,418increaseingeneralandadministrativeexpenses(ofwhich$6,223,938relatestoanincreaseinlitigationexpenses)anda$5,569,975increaseinproductdevelopmentandclinicaltrialexpensestoadvancetheTiaraandReducerdevelopmentprograms.
SellingexpensesfortheyearendedDecember31,2015were$655,669,comparedto$157,390forthesameperiodin2014,representinganincreaseof$498,279,or317%.
TheincreaseinsellingexpensesfortheyearendedDecember31,2015comparedtothesameperiodin2014reflectscostsincurredforReducercommercializationactivitiesin2015.
TheCompanyanticipatesasignificantincreaseinsellingexpensesin2016asitcontinuesitscommercializationoftheReducerinselectcountriesinEurope.
GeneralandadministrativeexpensesfortheyearendedDecember31,2015were$13,913,076,comparedto$10,725,658forthesameperiodin2014,representinganincreaseof$3,187,418,or30%.
TheincreaseingeneralandadministrativeexpensesfortheyearendedDecember31,2015comparedtothesameperiodin2014canbesubstantiallyexplainedbya$6,223,938increaseinlitigationexpensesanda$703,989increaseincash-basedemployeeexpenses,offsetbya$3,480,148decreaseinshare-basedpayments.
In2015theCompanyadjusteditscompensationplantodirectors,officersandseniormanagement,decreasingthenumberofoptionsgrantedby75%,replacingtheseoptionswithasmallercashbasedbonusplanandincreasingofficersandseniormanagement'sbasesalariesby10%.
Othercashbasedemployeeexpensesarerelatedtoadditionalheadcountinquality,financeandhumanresourcedepartmentsandwithotheremployeeexpenses.
ProductdevelopmentandclinicaltrialexpensesfortheyearendedDecember31,2015were$17,181,395,comparedto$11,611,420forthesameperiodin2014,representinganincreaseof$5,569,975,or48%.
TheincreaseinproductdevelopmentandclinicaltrialexpensesfortheyearendedDecember31,2015wasduetoa$1,943,414increaseincash–basedemployeeexpensesastheCompanyhiredadditionalstafftoadvanceproductdevelopment,a$4,707,064increaseinotherexpensesastheCompanyinvestedinitstwomajornewproductinitiatives,offsetbya$1,198,786decreaseinshare-basedpayments.
TheCompany'sexpensesaresubjecttoinflationandcostincreases.
Salariesandwageshaveincreasedonaverageby6%intheyearendedDecember31,2015comparedtothesameperiodin2014.
TheCompany4hasnotseenamaterialincreaseinthepriceofanyofthecomponentsusedinthemanufactureofitsproductsandservices.
OtherIncomeTheotherincomefortheyearendedDecember31,2015was$2,195,195,comparedto$94,427forthesameperiodin2014.
TheCompany'sinvestmentsinhighinterestsavingsaccountsandguaranteedinvestmentcertificatesgenerated$577,006interestduringtheyearendedDecember31,2015.
TheCompanybenefitedfromsignificantforeignexchangegainsonitsforeigncurrency-denominatedcashandcashequivalentsandaccountsreceivableduringtheyearendedDecember31,2015of$1,620,727.
LossesTheoperatinglossesandcomprehensivelossesfortheyearendedDecember31,2015were$26,730,490and$35,116,695respectively,or$0.
41basicanddilutedlosspershare,ascomparedwithlossesof$17,175,745and$18,154,725,or$0.
33basicanddilutedlosspershareforthesameperiodin2014.
The$9,554,745increaseintheoperatinglossincurredfortheyearendedDecember31,2015comparedtothesameperiodin2014canbesubstantiallyexplainedbya$2,232,490decreaseingrossprofit,a$3,187,418increaseingeneralandadministrativeexpenses(ofwhich$6,223,938relatestoanincreaseinlitigationexpenses),a$5,569,975increaseinproductdevelopmentandclinicaltrialexpenses,andoffsetbya$2,100,768increaseinotherincome.
LitigationexpensesfortheyearendedDecember31,2015representalossof$0.
11basicanddilutedlosspersharecomparedtoalossof$0.
02basicanddilutedlosspershareforthesameperiodin2014.
TheCompanyhasincurredsignificantcostsindefendingitselfinlawsuitsfiledbyCardiAQValveTechnologies,Inc.
TotallitigationcostssincetheinitialclaimswerefiledinJune2014areapproximately$7.
89millionandtheCompanymayrequireanadditional$7.
5milliontocoveradditionallitigationexpensesuptoandincludingthetrial,scheduledforMay2016.
DiscussionofLiquidityandCapitalResourcesNeovascfinancesitsoperationsandcapitalexpenditureswithcashgeneratedfromoperations,linesofcreditandequityfinancings.
AtDecember31,2015,theCompanyhadcashandcashequivalentsof$55,026,171comparedtocashandcashequivalentsof$5,193,561andshortterminvestmentsof$10,343,999atDecember31,2014.
CashusedinoperatingactivitiesfortheyearendedDecember31,2015,was$21,282,958,comparedto$8,063,446forthesameperiodin2014.
FortheyearendedDecember31,2015,operatingexpenseswere$22,693,678,comparedto$8,202,450forthesameperiodin2014,cashexpendituresonlitigation(litigationexpenseslesschangeinaccountspayablerelatedtolitigation)wereapproximately$6.
0millionandcashexpendituresonresearchanddevelopmentandclinicaltrials(expenseslesssharebasedpaymentsanddepreciation)wereapproximately$6.
6million.
Workingcapitalitemsgeneratedcashof$821,165,comparedto$39,960forthesameperiodin2014,asaccountsreceivableabsorbedcashdueatyearendduetoalatepaymentreceivedimmediatelyaftertheyearend,inventoryabsorbedcashprincipallyinthedevelopmentofreasonableworkingquantitiesofReducerinventory,prepaidexpensesandotherassetsgeneratedcashduetodecreasedprepaymentandaccountspayablepreservedcashatyearendduetosignificantlitigationexpensesincurredbutnotpaidforofapproximately$1.
1millionasatDecember31,2015.
OutstandingShareDataAsatMarch29,2016,theCompanyhad66,837,345commonvotingsharesissuedandoutstanding.
Further,thefollowingsecuritiesareconvertibleintocommonsharesoftheCompany:8,171,966stockoptionswithaweightedaveragepriceofCDN$3.
96.
ThefullydilutedsharecapitaloftheCompanyatMarch29,2016is75,008,711.
Neovasc's2015FinancialStatementsandNotes,itsManagement'sDiscussionandAnalysis,itsAnnualInformationFormanditsForm40-FwillbepostedontheCompany'swebsiteatwww.
neovasc.
comandwillbe5filedonSEDARandEDGAR.
Inadditiontothesummarycontainedherein,readersareencouragedtoreviewthefulldisclosureinNeovasc'sFinancialStatementsforthetwelvemonthsendingDecember31,2015andManagement'sDiscussionandAnalysis.
ConferenceCallandWebcastInformationNeovascwillbehostingaconferencecalltodayat4:30pmETtodiscusstheseresults.
Toparticipateintheconference,dial8883900549or4167648682.
Arecordingofthecallwillbeavailablefor72hoursbycalling8883900541or4167648677andusingpasscode825521#.
AlinktotheliveandarchivedaudiowebcastoftheconferencecallwillalsobeavailableonthePresentationsandEventspageoftheInvestorssectionofNeovasc'swebsiteatwww.
neovasc.
com.
ConsolidatedStatementsofFinancialPositionAsatDecember31,(ExpressedinUnitedStatesdollars)20152014ASSETSCurrentassetsCashandcashequivalents$55,026,171$5,193,561Investments-10,343,999Accountsreceivable1,736,9411,543,817Inventory598,136410,290Prepaidexpensesandotherassets146,590223,483Totalcurrentassets57,507,83817,715,150Non-currentassetsProperty,plantandequipment3,720,5562,653,271Totalnon-currentassets3,720,5562,653,271Totalassets$61,228,394$20,368,421LIABILITIESANDEQUITYLiabilitiesCurrentliabilitiesAccountspayableandaccruedliabilities$3,232,971$2,166,268Currentportionoflong-termdebt-38,437Totalcurrentliabilities3,232,9712,204,705Non-currentliabilitiesLong-termdebt-135,875Totalnon-currentliabilities-135,875Totalliabilities3,232,9712,340,580EquitySharecapital161,505,03789,357,061Contributedsurplus20,569,11017,632,809Accumulatedothercomprehensiveloss(8,790,011)(403,806)Deficit(115,288,713)(88,558,223)Totalequity57,995,42318,027,841Totalliabilitiesandequity$61,228,394$20,368,4216ConsolidatedStatementsofLossandComprehensiveLossFortheyearsendedDecember31,(ExpressedinUnitedStatesdollars)20152014REVENUEReducer$526,412$-Productsales353,7362,054,042Contractmanufacturing3,236,9783,033,976Consultingservices5,812,8149,282,6499,929,94014,370,667COSTOFGOODSSOLD6,938,1349,146,371GROSSPROFIT2,991,8065,224,296EXPENSESSellingexpenses655,669157,390Generalandadministrativeexpenses13,913,07610,725,658Productdevelopmentandclinicaltrialsexpenses17,181,39511,611,42031,750,14022,494,468OPERATINGLOSS(28,758,334)(17,270,172)OTHERINCOME/(EXPENSE)Interestincome577,006198,677Interestexpense(2,538)(6,991)Lossondisposalofpropertyandequipment-(29,406)Gain/(Loss)onforeignexchange1,620,727(67,853)2,195,19594,427LOSSBEFORETAX(26,563,139)(17,175,745)Taxexpense(167,351)-LOSSFORTHEYEAR$(26,730,490)$(17,175,745)OTHERCOMPREHENSIVELOSSFORTHEYEARExchangedifferenceontranslation(8,386,205)(978,980)LOSSANDCOMPREHENSIVELOSSFORTHEYEAR$(35,116,695)$(18,154,725)LOSSPERSHAREBasicanddilutedlosspershare$(0.
41)$(0.
33)7ConsolidatedStatementsofCashFlowsFortheyearsendedDecember31,(ExpressedinUnitedStatesdollars)20152014OPERATINGACTIVITIESLossfortheyear$(26,730,490)$(17,175,745)Adjustmentsfor:Depreciation503,709339,372Share-basedpayments4,114,1658,603,791Lossondisposaloffixedassets-29,406Write-downaccountsreceivable25,893192,412Interestincome(609,493)(198,677)Interestexpense2,5386,991(22,693,678)(8,202,450)Netchangeinnon-cashworkingcapitalitems:Accountsreceivable(468,478)(574,042)Inventory(269,605)3,334Prepaidexpensesandotherassets31,592(210,530)Accountspayableandaccruedliabilities1,527,656821,198821,16539,960Interestpaidandreceived:Interestreceived592,093106,035Interestpaid(2,538)(6,991)589,55599,044Netcashappliedtooperatingactivities(21,282,958)(8,063,446)INVESTINGACTIVITESRedemptionof/(Investmentin)guaranteedinvestmentcertificates9,322,492(10,900,599)Purchaseofproperty,plantandequipment(2,143,128)(1,120,345)Netcashfrom/(appliedto)investingactivities7,179,364(12,020,944)FINANCINGACTIVITIESRepaymentoflong-termdebt(164,364)(37,456)Proceedsfromshareissuepursuanttoanunderwrittenpublicoffering,netofshareissuecosts69,879,21022,116,736Proceedsfromexerciseofoptions1,090,092175,679Netcashfromfinancingactivities70,804,93822,254,959NETCHANGEINCASHANDCASHEQUIVALENTS56,701,3442,170,569CASHANDCASHEQUIVALENTSBeginningoftheyear5,193,5613,199,944Exchangedifferenceoncashandcashequivalents(6,868,734)(176,952)Endoftheyear$55,026,171$5,193,561Representedby:Cash7,860,728784,461Cashablehighinterestsavingsaccounts25,490,4434,409,100Cashableguaranteedinvestmentcertificates21,675,000-$55,026,171$5,193,5618AboutNeovascInc.
Neovascisaspecialtymedicaldevicecompanythatdevelops,manufacturesandmarketsproductsfortherapidlygrowingcardiovascularmarketplace.
ItsproductsindevelopmentincludetheTiara,forthetranscathetertreatmentofmitralvalvediseaseandtheNeovascReducerforthetreatmentofrefractoryangina.
TheCompanyalsosellsalineofadvancedbiologicaltissueproductsthatareusedaskeycomponentsinthird-partymedicalproductsincludingtranscatheterheartvalves.
Formoreinformation,visit:www.
neovasc.
com.
Thisnewsreleasecontainsforward-lookingstatementswithinthemeaningoftheU.
S.
PrivateSecuritiesLitigationReformActof1995andapplicableCanadiansecuritieslawsrelatingtotheCompany'spriorityin2016tocompleteallnecessaryregulatoryandclinicalactivitytobeginaCEMarktrialforTiara;theCompany'sstrategytorefocusitsbusinesstowardsdevelopmentandcommercializationoftheNeovascReducerandTiara;thelikelihoodofsteadyoracceleratedpatientenrolmentintheTIARA-IEarlyFeasibilityTrial;theanticipatedgrowthofcontractingmanufacturinginthelong-termbasedongrowthofdemandforourcustomers'products;thematurationofthetranscatheteraorticvalvemarket;theanticipatedgrowthoftheCompany'sbaseofbusinessinEurope;theexpecteddeclineofconsultingservicesrevenueinthelongtermastheCompany'sconsultingcustomersbecomecontractmanufacturingcustomers;theexpectedincreaseofsellingexpensesin2016astheCompanycontinuescommercializationoftheNeovascReducer;andtheamountofestimatedadditionallitigationexpensesrequiredtodefendtheCompanyinlawsuitsfiledbyCardiaqValveTechnologies,Inc.
Thewords"expect","anticipate","may","will","intend,"and"believe"areintendedtoidentifyforward-lookingstatements.
Forward-lookingstatementsarebasedonestimatesandassumptionsmadebytheCompanyinlightofitsexperienceanditsperceptionofhistoricaltrends,currentconditionsandexpectedfuturedevelopments,aswellasotherfactorsthattheCompanybelievesareappropriateinthecircumstances.
ManyfactorsandassumptionscouldcausetheCompany'sactualresults,performanceorachievementstodiffermateriallyfromthoseexpressedorimpliedbytheforward-lookingstatements,including,withoutlimitation,theconductorpossibleoutcomesofanyactualorthreatenedlegalproceedings,whichareinherentlyuncertain;thepotentialbenefitsoftheNeovascReducerandTiaraascomparedwithotherproducts;successfulenrollmentofpatientsinstudiesandtrialsfortheNeovascReducerandTiara;resultsofthetrialsandstudiesfortheNeovascReducerandTiarathatmeettheCompany'sexpectations;theCompany'sreceiptofanyrequiredlocalandinstitutionalregulatoryapprovalsandthetimingandcostsofobtainingsuchapprovals;Europeanenrollmentinourclinicaltrials,studiesandcompassionateusecasesandthesuccessofapplicationsinEurope;theCompany'sabilitytoprotectitsintellectualproperty;theCompany'sabilitytoraiseadditionalfunding;changesinbusinessstrategyordevelopmentplans;existinggovernmentalregulationsandchangesin,orthefailuretocomplywith,governmentalregulationsandgeneraleconomicandbusinessconditions,bothnationallyandintheregionsinwhichtheCompanyoperates.
TheseriskfactorsandothersrelatingtotheCompanyarediscussedingreaterdetailinthe"RiskFactors"sectionoftheCompany'sAnnualInformationForm,whichisincludedinitsAnnualReportonForm40-F(copiesofwhichfilingsmaybeobtainedatwww.
sedar.
comorwww.
sec.
gov).
Thesefactorsshouldbeconsideredcarefully,andreadersshouldnotplaceunduerelianceontheCompany'sforward-lookingstatements.
TheCompanyhasnointentionandundertakesnoobligationtoupdateorreviseanyforward-lookingstatements,whetherasaresultofnewinformation,futureeventsorotherwise,exceptasrequiredbylaw.
###InvestorRelationsNeovascInc.
ChrisClark604248-4138cclark@neovasc.
com
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