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2016THIRDQUARTERAND9MONTHSBUSINESSANDFINANCIALUPDATE
Statement of the Board InaccordancewithArticle5:25cparagraph2subcoftheFinancialSupervisionActtheBoardoftheCompanyconfirmsthat,tothebestoftheirknowledge,(i)thefinancialstatementsinthisthirdquarterreport2016giveatrueandfairviewofCuretis N.V.’s assets, liabilities, and financial position as at September 30, 2016, and the results of its consolidatedoperationsforthefinancialthirdquarter2016;and(ii)theReportincludesafairreviewofthepositionasofSeptember30,2016,andthedevelopmentandperformanceduringtheninemonthsofthefinancialyear2016ofCuretisN.V.
Forward looking statement (disclaimer) Thisthirdquarter2016businessandfinancialupdatereportisprovidedtoyousolelyforyourinformation.Thisreport,whichhasbeenpreparedbytheCompany,maynotbereproducedinanyform,furtherdistributedorpassedon,directlyorindirectly,toanyotherperson,orpublished,inwholeorinpart,foranypurpose.Anyfailuretocomplywiththeserestrictionsmayconstituteaviolationofapplicablesecuritieslaws.Forthepurposesofthisnotice,“report”meansthisdocument,itscontentsoranypartofit.
Thisreportdoesnot,andisnotintendedto,constituteorformpartof,andshouldnotbeconstruedas,anoffertosell,orasolicitationofanoffertopurchase,subscribefororotherwiseacquire,anysecuritiesoftheCompany,norshallitoranypartofitformthebasisoforberelieduponinconnectionwithoractasanyinducementtoenterintoanycontractorcommitmentorinvestmentdecisionwhatsoever.ThisreportisnotanofferofsecuritiesforsaleintheUnitedStates.ThesecuritiesoftheCompanyhavenotbeenregisteredundertheussecuritiesactof1933,asamended(the“securitiesact”)orwithanysecuritiesregulatoryauthorityofanystateorotherjurisdictionoftheUnitedStatesandmaynotbeofferedorsoldintheUnitedStatesunlessregisteredunderthesecuritiesactorpursuanttoanexemptionfromsuchregistration.
Thisreportismadeavailableontheexpressunderstandingthatitdoesnotcontainallinformationthatmayberequiredtoevaluate,andwillnotbeusedbytherecipientsinconnectionwith,thepurchaseoforinvestmentinanysecuritiesoftheCompany.Thisreportisaccordinglynotintendedtoformthebasisofanyinvestmentdecisionanddoesnotconstituteorcontain(expressorimplied)anyrecommendationbytheCompanyoranyofitsdirectors,officers,employees,agents,affiliatesoradvisers.
Certaininformationinthisreportisbasedonmanagementestimates.SuchestimateshavebeenmadeingoodfaithandrepresentthecurrentbeliefsofapplicablemembersoftheboardoftheCompany(theBoard).ThoseBoardmembersbelievethatsuchestimatesarefoundedonreasonablegrounds.However,bytheirnature,estimatesmaynotbecorrectorcomplete.Accordingly,norepresentationorwarranty(expressorimplied)isgiventhatsuchestimatesarecorrectorcomplete.
Thisreportmayincludestatementsthatare,ormaybedeemedtobe,"forward-lookingstatements".Theseforward-lookingstatementscanbeidentifiedbytheuseofforward-lookingterminology,includingbutnotlimitedtotheterms"believes","estimates","anticipates","expects","intends","may","will",or"should",andincludestatementstheCompanymakesconcerningtheintendedresultsofitsstrategy.Bytheirnature,forward-lookingstatementsinvolverisksanduncertaintiesandreadersarecautionedthatanysuchforward-lookingstatementsarenotguaranteesoffutureperformance.TheCompany’sactualresultsmaydiffermateriallyfromthosepredictedbytheforward-lookingstatements.TheCompanyundertakesnoobligationtopubliclyupdateorreviseforward-lookingstatements,exceptasmayberequiredbylaw.
THIRD QUARTER 2016 OPERATIONAL AND BUSINESS HIGHLIGHTS
UNYVERO U.S. FDA CLINICAL TRIAL DELIVERS STRONG TOP-LINE DATA AFTER THE END OF Q3-2016
• CuretishassuccessfullycompletedtheU.S.FDAtrialfortheUnyveroPlatformanditsLRTApplicationinlowerrespiratorytractinfectionswithpositivetoplinedataanalyzedandreportedaftertheendofQ3inOctober2016.Theprospectiveandretrospectivestudymetitsprimaryendpointbydemonstratinganoverallweightedaveragesensitivityof90.2%andanoverallaverageweightedspecificityof99.3%.ThesedataarefullyconsistentandinlinewiththeperformanceevaluationpreviouslyconductedbyCuretisforCEIVDmarkinginEurope,aswellaspublisheddatafromvariousEuropeanKOLsandcustomersites.Atotalof2,203prospectiveandretrospectivesampleshavebeentestedatninetrialsitesacrosstheU.S.resultinginmorethan350,000datapointsfromUnyveroCartridges,frommicrobiologycultureandfromindependentmoleculartestingusingPCRandsequencing.
• ThesubmissionofCuretis´(denovo)510(k)datapackagetotheU.S.FDAisexpectedinduecourse.FDAfeedbackandpotentialclearanceforUnyveroandsubsequentstartofcommercializationareexpectedinthefirsthalfof2017.
• CuretishasbegunpreparingtoenterU.S.FDAtrialsforitsnextU.S.product.Tothatend,theCompanysubmittedaso-calledpre-submissionpackagetotheU.S.FDA,whichoutlinestheintendeduseclaimsandaproposedstudydesignforaU.S.versionofitsUnyveroITICartridge.BasedontheFDA’sfeedbackandadditionalmarketresearchdataexpectedinQ4-2016,CuretiswilldetermineappropriatenextstepsandtimelinesforaU.S.FDAtrialforitssecondproduct.Furtherdetailswillbeannouncedin2017.
ACQUISITION OF NGS DATABASE GEAR AND IP FROM SIEMENS
• InQ3CuretishasacquiredsolecommercialrightsfromSiemensTechnologyAcceleratortotheGEAR(GEneticAntibioticResistanceandSusceptibility)platformanddatabasewithallitscontent,numerousGEAR-relatedpatentsandpatentapplications,aswellasallcorrespondingknow-how.ThedealgivesCuretissoleworldwideproductdevelopmentandcommercialrights,includingtherighttosublicenseinthefieldsofhumanandanimaldiagnosticsaswellasfoodsafetytesting.Furthermore,CuretishassecuredthesolerightstoleveragetheGEARassetsincollaborationwithpharmaceuticalcompaniesforthedevelopmentofnovelantimicrobialdrugsforhumanandanimalhealth.
• Thestate-of-the-artbioinformaticsdatabasecomprisesmorethan11,300bacterialstrainsthathavebeencollectedatmorethan200siteson5continentsover30years.Thenextgenesequencing(NGS)datawith0.4trillionreadsisawealthofcomprehensiveandinternationallyrelevantinformationamountingto30terabytesintotal.
• GEARwillallowCuretistorapidlyidentifypotentialnovelbiomarkers,biomarkercombinations,andalgorithmspredictingantibioticresistance,aswellaspotentialnoveltargetsforantimicrobialdrugs.TheacquisitionoftheGEARdatabaseandpatentestateaddssignificantlytotheleadershippositionthatCuretishasestablishedintheareaofgeneticantimicrobialresistancebiomarkertestingwithitsUnyveroApplicationCartridges.CuretiswillfurtherexpandandminetheGEARdatabaseincollaborationwithleadingacademicinstitutionsaswellas
pharmaceuticalanddiagnosticscompaniesandleveragethoseintocommercialproductsonitsUnyveroMolecularDiagnosticsplatformandbeyond.
COMMERCIAL OPERATIONS EXPANSION ON TRACK
• UnitedStates
TheCompanyhiredChristopherM.Bernardintothenewly-createdroleofPresidentandChiefExecutiveOfficerofCuretisUSA,Inc.inLaJollaSanDiego,CA.DuringQ3andintoQ4thecompanyhasbeenbuildingitsseniorleadershipandU.S.commercialcoreteamfortheNorthAmericanmarket.TheU.S.companyhasbeenfoundedtodrivethefuturecommercialdevelopmentandsalesoftheCompany’sUnyveroPlatforminNorthAmerica.CuretisisplanningdirectcommercializationofallUnyveroProductsintheU.S.hospitalmarket.
• Europe
TheCompanyhasmadeexcellentprogressinexpandingitscommercialfootprintinitsdirectsalesterritories.Tothisend,CuretishasestablishedfournewwhollyownedcommercialsubsidiariesinEuropecoveringtheUK,theNetherlandsfortheBeneluxarea,FranceandSwitzerlandandhashiredseniormarketdevelopmentmanagersandkeyaccountmanagersfromindustryleaderssuchasRoche,Cepheid,Abbottandothers.
PRODUCT DEVELOPMENT PROGRESS ON SCHEDULE • AfterlaunchingtheBCUBloodCultureApplicationCartridgeinQ2-2016,inQ3Curetishas
launcheditssecondUnyverotestthisyearwithitsnextgenerationUnyveroITICartridgeforImplantandTissueInfectionsinSeptember.TheCEPerformanceevaluationstudywassuccessfullycompletedanddemonstratedanoverallaveragesensitivityforallpathogensof86.9%andanoverallaveragespecificityforallpathogensof99.2%inatotalof1,100samples.Thenext-generationcartridgenowcoversatotalof102(upfrom80inthefirstgeneration)diagnostictargets:85ofthemostclinicallyrelevantpathogenicmicroorganisms,includingGrampositiveandGramnegativebacteria,severalfungi,and17relatedantibioticresistancemarkers.
• TheCompanyhasfurthermoreprogressedthedevelopmentofitsfourthUnyveroApplicationtowardscompletionbytheendofthisyear;theIAIIntra-AbdominalInfectionCartridge.Inaddition,thefifthUnyveroApplicationCartridge,apartneredSepsisHostResponseprogram(anticipatedcompletionnotbeforetheendof2017)isprogressingaccordingtoplan.
INSTALLED BASE UP 53% YEAR OVER YEAR
• CuretishascontinuedtoexpandtheinstalledbaseofUnyveroAnalyzersto121asofSeptember30,2016(vs.79instrumentsasofSeptember30,2015i.e.anincreaseby53%yearoveryear).
NINE MONTHS 2016 FINANCIAL HIGHLIGHTS
• Revenues:EUR1,077thousand(vs.EUR885thousandintheninemonthsendedSeptember30,2015).Overallrevenueswereupby21.7%yearoveryear.However,whilerevenuesinthefirsthalfof2015hadincludedEUR297thousandUnyveroSystemssalestoapharmapartner,revenuesinthesameperiodin2016didnotincludeanysuchsystemsalestopharma.Ingeneral,revenuesareexpectedtoremainvolatilefromquarter-to-quarter,asearly-stageinstrumentsalestodistributionpartnersareunevenlyspreadthroughouttheyear.
• Expenses:EUR12.0million(vs.EUR9.6millionintheninemonthsendedSeptember30,2015).Theincreaseisinlinewiththeoperationalandorganizationalgrowth,anddrivenbyhigherR&Dexpenses,distributioncostsaswellasG&Acosts.
• Grossloss:EUR109.4thousand(vs.agrosslossofEUR451.3thousandintheninemonthsendedSeptember30,2015).TherelativelylowgrossmarginissignificantlyimpactedbythemixofsystemsalestocartridgesalesandbyIFRSaccountingrequiringexcesscapacityofthecartridgemanufacturinglineandfacilitytobeallocatedtoactualperiodcartridgeoutput.
• Netloss:EUR10.7million(vs.aprofitofEUR13.5millionintheninemonthsendedSeptember30,2015).TheprofitintheninemonthsendedSeptember30,2015wasdueto23.6millionfinancialincomeresultingfromaone-timeaccounting-effectduetotherevaluationofpreferredandcommonsharesunderIFRS.
• Cashandcashequivalents:AstrongcashpositionofEUR35.4millionasofSeptember30,2016(vs.EUR46.1millionasofDecember31,2015)andanetcashburnof10.6EURmillionduringthe9monthsof2016foralloperating,investmentandfinancingactivitiescombined.
THIRD QUARTER AND NINE MONTHS 2016 CONSOLIDATED FINANCIAL STATEMENTS
CURETIS N.V. CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME (UNAUDITED) FortheninemonthsperiodendedSeptember30,2016
inEuroNinemonthsendedSeptember30,2016
NinemonthsendedSeptember30,2015
Revenue 1,077,412 885,146
Costofsales 1,186,774 1,336,425
Grossloss/grossmargin -109,362 -451,279
Distributioncosts 3,445,681 1,948,643
Administrativeexpenses 2,112,341 1,802,525
Research&developmentexpenses 5,239,429 4,558,546
Otherincome 146,537 85,328
Operatingloss -10,760,276 -8,675,665
Financeincome 68,729 23,616,090
Financecosts 48,973 1,447,896
Financeincome/costsfairvaluemeasurement 0 0
Financecosts-net 19,756 22,168,194
Profit/lossbeforeincometax -10,740,520 13,492,529
Incometaxexpenses - -
Profit/lossfortheperiod -10,740,520 13,492,529
Othercomprehensiveincomefortheyear,nettax 9,417 -
Totalcomprehensiveincomefortheperiod -10,731,103 13,492,529 ComparativefiguresforninemonthsendedSeptember30,2015arethoseofCuretisGmbH(formerAG)
CURETIS N.V. CONSOLIDATED STATEMENT OF FINANCIAL POSITION –ASSETS (UNAUDITED) AsofSeptember30,2016s Assets
inEuro 30September2016 31December2015
Currentassets 42,226,844 50,573,547
Cashandcashequivalents 35,415,220 46,060,397
Tradereceivables 414,439 1,072,131
Inventories 5,487,595 2,786,887
Othercurrentassets 909,590 654,132
Non-currentassets 7,775,494 6,823,465
Intangibleassets 2,541,900 645,120
Property,plantandequipment 4,689,935 5,605,496
Othernon-currentassets 222,776 223,846
Othernon-currentfinancialassets 320,883 349,003
Deferredtaxassets - -
Totalassets 50,002,338 57,397,012
ComparativefiguresasofDecember31,2015arethoseofCuretisGmbH(formerAG)
CURETIS N.V. CONSOLIDATED STATEMENT OF FINANCIAL POSITION – LIABILITY & EQUITY (UNAUDITED) AsofSeptember30,2016s Equity and Liabilities
inEuro30September
2016 31December2015
Currentliabilities 5,537,633 2,446,095
Tradeandotherpayables 3,479,688 863,342
LiabilityPSOP 367,308 367,308
Provisionscurrent 26,300 29,300
Othercurrentliabilities 1,069,133 676,502
Othercurrentfinancialliabilities 595,204 509,643
Non-currentliabilities 38,035 155,926
Provisionsnon-current 38,035 38,035
ProvisionPSOP - -
Othernon-currentfinancialliabilities - 117,891
Financialliabilityforpreferredandcommonshares - -
Deferredtaxliability - -
Totalliabilities 5,575,668 2,602,021
Equity
44,426,670 54,794,991
Sharecapital 155,384 155,384
Capitalreserve 153,156,129 152,793,347
Otherreserves 6,592,373 6,592,372
Currencytranslationdifferences 9,417 -
Retainedearnings -115,486,633 -104,746,112
TotalEquityandliabilities 50,002,338 57,397,012 ComparativefiguresasofDecember31,2015arethoseofCuretisGmbH(formerAG)
CURETIS N.V. CONSOLIDATED STATEMENT OF CASH FLOWS (UNAUDITED) FortheperiodendedSeptember30,2016
inEuro ninemonthsended ninemonthsended
September30,2016 September30,2015
Profitbeforeincometax -10,740,520 13,492,529
Adjustmentfor: -Netfinanceincome/costs -19,756 -22,168,194
-Depreciation,amortizationandimpairments 1,353,620 1,263,639
-Gainondisposaloffixedassets 1,550 7,312
-Changesinprovisions -3,000 2,513,996
-Changesinvaluationofequitysettledstockoptions 362,782 0
-ChangesinvaluationofPSOP-liability 0 0
-Netexchangedifferences 35,374 -3,556
Changesinworkingcapitalrelatingto: -Inventories -2,700,708 42,666
-Tradereceivablesandotherreceivables 431,424 -40,808
-Tradepayablesandotherpayables 3,081,207 846,457
Effectsofexchangeratedifferencesnotrealizedfromconsolidation -25,956 0
Incometaxesreceived(+)/paid(-) 0 0
Interestspaid(-) -7,596 -12,466
Netcashflowprovidedbyoperatingactivities -8,231,579 -4,058,425
Paymentsforintangibleassets -2,016,199 -3,546
Paymentsforproperty,plantandequipment -320,191 -486,323
Proceedsfromsaleofproperty,plantandequipment 0 0
Interestsreceived 62,726 5,929
Netcashflowusedininvestingactivities -2,273,664 -483,940
Paymentsforfinanceleaseliabilities -104,560 -99,711
Cashreceivedfromcapitalincrease 0 12,778,054
Proceedsfromissueofordinaryshares 0 0
PaymentsforfinancingcostsforIPOofoldshares 0 -1,435,431
Transactioncostsforissueofordinaryshares 0 0
Netcashflowprovidedbyfinancingactivities -104,560 11,242,912
Netincrease(decrease)incashandcashequivalents -10,609,803 6,700,547
Netcashandcashequivalentsatthebeginningoftheyear 46,060,397 2,993,883
Netincrease(decrease)incashandcashequivalents -10,609,803 6,700,547
Effectsofexchangeratechangesoncashandcashequivalents -35,374 3,556
NetCashandcashequivalentsattheendoftheperiod 35,415,220 9,697,986
ComparativefiguresforninemonthsendedSeptember30,2015arethoseofCuretisGmbH(formerAG)
CURETIS N.V. CONSOLIDATED INTERIM STATEMENT OF CHANGES IN EQUITY (UNAUDITED) AsofSeptember30,2016
inEuroSharecapital
Capitalreserve
Otherreserve
Currencytransl.diff.
Retainedearnings
TOTALequity
BalanceatJanuary1,2015 50,000 0
0 0
-118,585,704
-118,535,704
Profitof9M-2015
13,492,529 13,492,529
Othercomprehensiveincomefor9M-2015
0 0
BalanceasofSeptember30,2015 50,000 0
0 0
-105,093,175
-105,043,175
inEuro
Sharecapital
Capitalreserve
Otherreserve
Currencytransl.diff.
Retainedearnings
TOTALequity
BalanceatJanuary1,2016 155,384 152,793,347
6,592,372 0
-104,746,112 54,794,991
Lossof9M-2016
-10,740,520 -10,740,520IFRS2Valuationofequitysettledstockoptions
362,782
362,782
Othercomprehensiveincomefor9M-2016
9,417
9,417
BalanceasofSeptember30,2016 155,384 153,156,129
6,592,372 9,417
-115,486,632 44,426,670
ComparativefiguresforperiodfromJanuary1,2015toSeptember30,2015arethoseofCuretisGmbH(formerAG)
CURETIS N.V. THIRD QUARTER AND NINE MONTHS 2016 BUSINESS AND FINANCIAL UPDATE IMPRINT ©2016 CURETIS N.V.