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2016 THIRD QUARTER AND 9 MONTHS BUSINESS AND FINANCIAL UPDATE

20161118 Third quarter and nine months 2016 Business and ... · In accordance with Article 5:25c paragraph 2 sub c of the Financial Supervision Act the Board of the Company confirms

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Page 1: 20161118 Third quarter and nine months 2016 Business and ... · In accordance with Article 5:25c paragraph 2 sub c of the Financial Supervision Act the Board of the Company confirms

2016THIRDQUARTERAND9MONTHSBUSINESSANDFINANCIALUPDATE

Page 2: 20161118 Third quarter and nine months 2016 Business and ... · In accordance with Article 5:25c paragraph 2 sub c of the Financial Supervision Act the Board of the Company confirms

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.

Page 3: 20161118 Third quarter and nine months 2016 Business and ... · In accordance with Article 5:25c paragraph 2 sub c of the Financial Supervision Act the Board of the Company confirms

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

Page 4: 20161118 Third quarter and nine months 2016 Business and ... · In accordance with Article 5:25c paragraph 2 sub c of the Financial Supervision Act the Board of the Company confirms

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).

Page 5: 20161118 Third quarter and nine months 2016 Business and ... · In accordance with Article 5:25c paragraph 2 sub c of the Financial Supervision Act the Board of the Company confirms

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.

Page 6: 20161118 Third quarter and nine months 2016 Business and ... · In accordance with Article 5:25c paragraph 2 sub c of the Financial Supervision Act the Board of the Company confirms

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)

Page 7: 20161118 Third quarter and nine months 2016 Business and ... · In accordance with Article 5:25c paragraph 2 sub c of the Financial Supervision Act the Board of the Company confirms

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)

Page 8: 20161118 Third quarter and nine months 2016 Business and ... · In accordance with Article 5:25c paragraph 2 sub c of the Financial Supervision Act the Board of the Company confirms

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)

Page 9: 20161118 Third quarter and nine months 2016 Business and ... · In accordance with Article 5:25c paragraph 2 sub c of the Financial Supervision Act the Board of the Company confirms

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)

Page 10: 20161118 Third quarter and nine months 2016 Business and ... · In accordance with Article 5:25c paragraph 2 sub c of the Financial Supervision Act the Board of the Company confirms

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)

Page 11: 20161118 Third quarter and nine months 2016 Business and ... · In accordance with Article 5:25c paragraph 2 sub c of the Financial Supervision Act the Board of the Company confirms

CURETIS N.V. THIRD QUARTER AND NINE MONTHS 2016 BUSINESS AND FINANCIAL UPDATE IMPRINT ©2016 CURETIS N.V.

Page 12: 20161118 Third quarter and nine months 2016 Business and ... · In accordance with Article 5:25c paragraph 2 sub c of the Financial Supervision Act the Board of the Company confirms