interim report 2017 q1mb.cision.com/main/13456/2256336/668422.pdf · • corporate presentations at...
TRANSCRIPT
INTERIM REPORT 2017 Q1
3 CEO statement 4 Q1 in brief 5 Our development pipeline 6 Operational overview 8 Financial overview 9 Other disclosures 10 Financial statements 18 Keyfigures&definitions 19 Financial notes
CONTENTS
Camurusiscommittedtodevelopingandcommercializinginnovativeandlong-actingmedicinesforthetreatmentofsevereandchronicconditions,includingopioiddependence,pain,cancerandendocrinedisorders.Newdrugproductsarebasedonourproprietary FluidCrystal®drugdeliverytechnologieswiththepurposetodeliverimprovedqualityoflife,treatmentoutcomesandresourceutilization.Thecompany’sshareislistedonNasdaqStockholmundertheticker“CAMX”. For more information, visit camurus.com
”New top-line Phase 3 results support the long- term safety and efficacy of CAM2038 in patients with opioid dependence. After completing pre- submission meetings with EMA and FDA, market approval applications for CAM2038 are now being finalized.”FINANCIAL CALENDAR
AnnualGeneralMeeting 3May2017Q22017 13July2017Q32017 26October2017FullYearReport2017 15February2018AnnualReport2017 22March2018
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CEO STATEMENT
Wehadabusyandproductivefirstquarterwithfiveongoingclinicaltrialsandseveralstudiesunder initiation.Thelastpatientscompletedtreat-mentinthePhase3long-termsafetystudyofCAM2038,weeklyandmonthlybuprenorphinedepots.Newtop-linePhase3resultssupportthelong-termsafetyandefficacyofCAM2038inpatientswithopioiddependence.Havingconcludedpre-submissionmeetingswithEMAandFDA,marketapprovalapplicationsforCAM2038arenowbeingfinalized.
Duringthefirstquarter,wecompletedtreatmentofallpatientsintheopen-label,long-termsafetyPhase3studyofourweeklyandmonthlydepotsofbuprenorphinetogetherwithourUSpartnerBraeburnPharmaceuticals.228patientsinEurope,theU.S.andAustraliawererandomizedinthestudy.Toplineresultsdemon-stratedthattheCAM2038weeklyandmonthlydepotswerewelltoleratedandprovidedcontinuoustreatmenteffectacrossthe48-weektreatmentperiod.Studyretentionwashigh,with71% ofpatientscompletingthe48-weekstudytreatmentperiod.
Afterpositivepre-submissionmeetingswiththeregulatoryauthorities(EMAandFDA),wearetogetherwithBraeburn Pharmaceuticalsfinalizingourmarketmarketingauthorizationapplicationandnewdrugapplications(MAAandNDA)forsub-missionsinmid-2017.Thepreparationsforouranticipated2018launchofCAM2038inEuropeiswellon-track,withtheaimto
provide patients rapid access to a new treatment alternative with the potential to improve both treatment outcomes and qualityoflife.
WearealsoworkingtoexpandthefutureindicationsforCAM2038totreatmentofchronicpainandexpecttocomplete theongoingpivotalPhase3-studyinpatientswithchroniclow-backpainbeforetheendoftheyear.Duringtheperiod,ameetingwasheldwithFDAregardingtheproductregistrationforchronicpain.Thereisasignificantunmetmedicalneedfornewtherapeuticoptionsfortreatingchronicpain,highlighted by the current opioid crisis and issues of diversion, misuse, dependenceandoverdosesrelatingtotheuseofprescriptionopioids.CAM2038mayeffectivelyaddresstheseproblems andbecomeanimportanttreatmentalternative,includingforpatientsinneedforhigherdosesofopioidanalgesicsandrisksofdependence,andmayalsoprovideeffectiveandlong-actingpainrelief.
InourcollaborationwithNovartisforourlong-actingoctreo-tidedepot,CAM2029,fortreatmentofacromegalyandneuroen-docrinetumours,GMP-manufacturingwasperformedduringthe periodforNovartis’plannedstartofPhase3studieslaterthisyear. ResultsfromourpreviousPhase2studyofCAM2029in acro-megalyandNETpatientswerepresentedattwoscientificconfe-rences;ENETS2017inBarcelonaandENDO2017inOrlando.
In the early clinical pipeline, treatment of the last cohorts is ongoinginthePhase1studyofCAM2047fortreatmentofchemotherapy-inducednauseaandvomiting(CINV),andCAM2048andCAM2058fortreatmentofpain,nauseaandvomiting.Studyresultsareexpectedthirdquarter2017.We arealsopreparingthestartofthefirstclinicaltrialofoursub-
cutaneoustreprostinildepot,CAM2043,aimingatthedevelop- mentofanewtreatmentalternativeforpulmonaryarterialhyper- tension(PAH);arare,seriousandlife-threateningconditionaffectingthelungsandheart.
Camurusisexpandingwithgoodprospectsoffurthergrowthandcontinuedvaluecreation.Thisisreflectedbyanincreasinginterestfrombothpharmaceuticalcompaniesandthe international investor community, for instance, in connection withourpresentationsandatJ.P.MorganandCowenandCo.AnnualHealthCareConferencesearlierintheyear.
In parallel with the advances in our product pipeline, we are alsobuildingourcommercialorganizationfortheanticipatedlaunchofCAM2038in2018.Tosupportthebusinessexpansion, wehavestrengthenedthemanagementteamandorganizationwithnewfunctionsandexpertise.UrbanPaulsson,withbroadandinternationalexpertisefromthepharmaceuticalindustry, wasrecentlyappointedasVPCorporateDevelopment&General Counsel,andCeciliaCallmer,previouslyatNovoNordiskandFerringPharmaceuticals,hastakenthepositionasVPHumanResources.
Wehavehadagoodstartoftheyear,withtherecent announcementofpositivePhase3results,andarenowabouttoentertheregistrationphasewithCAM2038.Wearealsohavinggoodprogressinotherclinicalprogramsandlook forwardtoacontinuedpositivenewsflowduringtheyear.
Fredrik TibergPresident & CEO
Positive study results and continued development towards the market
Q1 IN BRIEF
Business highlights• AllpatientscompletedtreatmentinPhase3long-termsafety studyoflong-actingbuprenorphinedepotsinopioiddependent patients.• Pre-MAA/NDAmeetingsheldwithEMAandFDAfor weeklyandmonthlybuprenorphinedepotsfor treatmentofopioidusedisorder.• PresentationofPhase2resultsforlong-acting octreotideatENETS2017inBarcelona.• PublicationofpharmacokineticPhase1resultsforweekly andmonthlybuprenorphinedepotsinAdvancesinTherapy.• CorporatepresentationsatJ.P.MorganAnnual HealthcareConference2017andCowenandCo. AnnualHealthCareConference2017.• DistributionagreementsignedwithEthypharmfor episil®oralliquidinFrance.• UrbanPaulssonappointedasVPCorporate DevelopmentandGeneralCounseland CeciliaCallmerasVPHumanResources.
Significant events after the reporting period• PositivetoplinePhase3resultsfromlong-termsafety studyofCAM2038foropioiddependence.
Financial summary• RevenuesMSEK17.2(20.2).• OperatingresultMSEK-51.6(-24.9).• ResultaftertaxMSEK-40.2(-19.4).• EarningspershareSEK-1.08(-0.52),beforeandafterdilution.• CashpositionMSEK463.8(571.9).
Q1
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OUR DEVELOPMENT PIPELINE
A strong and diversified pipeline
1) Chemotherapy induced nausea and vomiting, 2) Postoperative nausea and vomiting. 3) Pulmonary arterial hypertension.
PARTNER PRODUCT PRE-CLINICAL PHASE 1-2 PHASE 3 REGISTRATION
CAM2038 q1wOPIOIDDEPENDENCE
CAM2038 q4wOPIOIDDEPENDENCE
CAM2038 q1wCHRONICPAIN
CAM2038 q4wCHRONICPAIN
CAM2029NEUROENDOCRINETUMORS
CAM2029ACROMEGALY
CAM2032PROSTATECANCER
CAM2047CINV1
CAM2048POSTOPERATIVEPAIN
CAM2058POSTOPERATIVEPAIN&PONV2
CAM4072GENETICOBESITY
CAM2043PAH3
PHASE3
PHASE3
PHASE3
PHASE3
PHASE1-2
PHASE1-2
PHASE1-2
PHASE1-2
PHASE1-2
CAM4071UNDISCLOSEDINDICATION
PHASE1-2
PHASE1-2
Camurusisaresearch-basedpharmaceuticalcompanywith afocusonthedevelopmentandcommercializationofnewand innovativepharmaceuticalsforseriousandchroniccondi- tions, where there are clear medical needs and the potential tosignificantlyimprovetreatment.ForthedevelopmentofnewdrugcandidatesCamurusutilizesitsownproprietaryformulationtechnology,forexample,thelong-actinginjec-tion depot FluidCrystal®.Newproprietarymedicineswithimproved properties and treatment outcomes are developed
bycombiningthecompany'spatenteddrugdeliverytechno-logieswithactiveingredientswithdocumentedsafetyandefficacyprofiles.Thesearedevelopedwithsignificantlylowercostandrisk,comparedwiththedevelopmentofcompletelynewpharmaceuticals.Camurus'developmentpipelinecon-tains product candidates for treatment of cancer and the side effectsofcancertreatment,endocrinediseases,painandaddiction,seefigure.Asummaryandstatusupdateonthedifferentprojectsisgivenbelow.
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OPERATIONAL OVERVIEW
CAM2038 – opioid dependenceOpioiddependenceisaserious,chronic,relapsingdiseaseandagrowingglobalhealthproblem.Medicationassisted treatment(MAT)withdailybuprenorphineandmethadonerepresents current standard of care and has been shown effectiveinreducingwithdrawalandcravings,misuseandspreadingofdiseases.However,thesetreatmentsarealsoassociated with limitations such as poor treatment adherence, misuse,medicationdiversion,andaccidentalpediatricexpo-sure.CAM2038includestwolong-actingsubcutaneousbuprenorphinedepotsfortreatmentofopioiddependence.TheproductsarebasedonCamurus'proprietaryFluidCrystal® Injectiondepottechnologyandareintendedforeitherweekly(q1w)ormonthly(q4w)administrationbyhealthcarepersonnelusingprefilledsyringes,providedwithmultipledoses,toallowindividualizedtreatmentofpatientswithopioiddependence.PatientsbeingtreatedwithCAM2038arefreedfromtheburden andstigmaassociatedwiththedaily,oftensupervised,distri-bution and administration of present buprenorphine medica-tions.CAM2038alsohasthepotentialtogeneratesubstantialsavingsforhealthcareandsocietybyreducingcostsoffrequent supervisedtreatment,improvingtreatmentcomplianceandloweringdiversion,misuseandabuse.
STATUS Q1InNovember2016,weannouncedpositiveresultsfromapivotal, randomized,double-blind,double-dummy,active-controlled, 24weeks,efficacyPhase3trialofCAM2038.TheresultsdemonstratedthatCAM2038metbothprimaryandsecondaryendpointsintermsofnon-inferiorrespectivelysuperiorefficacy ofCAM2038versusdailysublingualbuprenorphine/naloxonewhichisthecurrentStandardofCare.Inthefirstquarter,wecompleted treatment of opioid patients in the second Phase 3trialofCAM2038;anopen-label,long-termsafetystudyinpatientswithopioidusedisorder.PositivetoplineresultsfromthisstudywerereportedinMay2,2017.
Furthermore,aPhase2studyevaluatingpharmacokineticsofCAM2038duringrepeateddosingisbeingcompleted(seechronicpainsection).Thesestudiesarepartoftheregistration program,whichhasbeenagreedwithbothFDAandEMA.CAM2038haspreviouslybeengrantedFastTrackstatusforthetreatmentofopioiddependencebytheFDA,andapp-licationsformarketingapprovalsintheUSandEuropeareplannedtobesubmittedinmid-2017.
CAM2038 – chronic painChronicpainisaglobalhealthproblem,andiscausingdeteriorationingeneralhealth,reducedqualityoflife,decre-asedworkcapacityanddependenceandmisuseofstrongopioids.CAM2038isbeingdevelopedtoprovideround-the-clockpainrelief,whiledecreasingtherisksofrespiratorydepressionandfataloverdosesassociatedwithfullμ-opioidagonists,suchasmorphine,oxycodoneandfentanyl.ThepropertiesofCAM2038areconsideredtoconformtothe targetedpropertiesfortreatmentsofchronicpain,i.e.thecombinationoflonglastingefficaciousanalgesiawitha reducedriskofmisuse,abuseandillicitdiversion.
STATUS Q1In patients with chronic pain and opioid dependence, the Phase2trialofCAM2038assessingpharmacokinetics,analgesiaandsafetyprofilesofrepeatdosesofweeklyandmonthlyCAM2038isprogressing;twodosegroupshavebeencompletedandanadditionaldosegrouphasbeenincluded.Thestudyispresentlybeingfinalizedandresultsareexpectedinthesecondquarter2017.Inparallel,aPhase3pivotaltrialassessingefficacyofCAM2038inpatientswithmoderatetoseverechroniclowerbackpainisongoing.
CAM2029 – acromegaly and NETCAM2029isbeingdevelopedbyNovartis,withsupportfromCamurus,forthetreatmentofacromegalyandneuroendo-crinetumors.Theproductoffersimportantpotentialadvan-tagesovercurrentmarketedproducts,includingeasyadmi-nistration,significantlyincreasedbioavailabilityofoctreotide,andpotentialforenhancedtreatmentefficacyinpatientsforwhom current treatments provide only suboptimal treatment effects.CAM2029isaready-to-use,long-actingsubcutaneous injectiondepotoftheactivesubstanceoctreotideformulatedwithCamurus'proprietaryFluidCrystal®Injectiondepottech-nology.Itisprovidedinaprefilledsyringe,thusnotrequiringanypreparationsortemperatureconditioningpriortoadmi-nistration.Duetothesuperioreaseofhandlingandadminis-tration,CAM2029canbeconvenientlyadministeredbythepatients’themselves.
STATUS Q1TherecentlycompletedPhase2trialofCAM2029demon-stratedlong-actingoctreotidereleasewithwell-maintainedcontrolofsymptomsanddiseasebiomarkersafterswitchingpatientsfromthecurrentmarketleadingproductSandostatin® LAR®.TheefficacyevaluationwasbasedonassessmentofthecontrolofsymptomsinNETpatientsandplasmalevelsofinsulingrowthfactor-1andgrowthhormoneinacromegalypatients.TheresultswerepresentedinMarchatEuropeanNeuroendocrineTumorSociety2017inBarcelona,Spain,andinAprilattheEndocrineSocietyAnnualMeeting,ENDO2017,Orlando,Florida.Fullpublicationisbeingcompiled.Furthermore,Novartis,incollaborationwithCamurus,iscompletingGMPmanufacturingandotherpreparationsofPhase3trialsofCAM2029,plannedtostartin2017.
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CAM2032 – prostate cancerThewellestablishedhormonetherapiesforprostatecancerbasedonusinggonadotropinreleasinghormoneagonistssuchasleuprolide,areaimingatreductionofthetestosterone levelandtherebyimpedingthegrowthofcancercells.CAM2032isalong-actingsubcutaneousleuprolidedepotfor treatmentofprostatecancer.AdditionalpotentialindicationsforCAM2032includeprecociouspuberty,genderidentitydisorders,andendometriosis.ThismonthlydepotisbasedonCamurus’FluidCrystal®Injectiondepottechnologyandwillbeprovidedasasmalldosevolumeinaprefilledsyringerequiringnoreconstitutionorconditioning.CAM2032is beingdevelopedforeasysubcutaneousinjectionsbypatients themselves.
STATUS Q1Discussions with potential partners for further clinical developmentareongoing.
Early Pipeline ProjectsAtCamurus,wecontinuouslyassessnewopportunitieswhere ourdrugdeliverytechnologieseffectivelycanbeusedtodevelopdifferentiatedproducts.Ournewpipelineprojectsare generatedin-houseaswellasinpartnershipwithinternational biotech and pharmaceutical companies
STATUS Q1
CAM4071CAM4071isaproductcandidateinclinicaldevelopmentundertheoption,collaborationandlicensingagreementwith Novartis.Theproductisalong-actingformulationofanundis- closed peptide based on the FluidCrystal®Injectiondepot. APhase1trialofpharmacokineticsandpharmacodynamics,performedtogetherwithNovartis,hasbeencompletedandisbeingreported.
CAM2047 CAM2048, and CAM2058CAM2047,CAM2048,andCAM2058arethreeinvestigationaldrugproductsbasedonCamurus’FluidCrystal®InjectiondepotandarecurrentlyevaluatedinaPhase1trial.Theseinvestigationalproductsarebeingdevelopedfortreatmentofchemotherapyinducednauseaandvomiting(CAM2047),pain(CAM2048)andcombinedtreatmentofpostoperativepain,nauseaandvomiting(CAM2058).Resultsfromthe clinicalstudyareexpectedduringthethirdquarter2017.
CAM2043CAM2043isanewlong-actingsubcutaneoustreprostinildepot,basedonCamurus’FluidCrystal®injectiondepot,beingdevelopedfortreatmentofpulmonaryarterialhyper-tension(PAH).Datafromtherecentlycompletedpreclinicalprogram showpromisingplasmaexposurewithtreprostinil,comparable with those reported in infusion studies, and no significantreactionsattheinjectionsite.Apotentialclinicaldevelopmentprogramisbeingevaluatedforapossiblestartduringthesecondhalf-yearof2017.
Medical device – episil®
episil®oralliquidisamedicaldevicefortreatmentofinflamma- toryandpainfulconditionsintheoralcavity.Theproductprovidesfastpainreliefandprotectionofsoreandinflamedmucosalsurfaces,causedbye.g.oralmucositis,acommonandserioussideeffectofcancertreatment.Incontactwiththe buccal membrane, episil® transforms into a thin protective layerofgel,offeringeffectivepainreliefforupto8hours.episil® oralliquidisbasedonCamurus’FluidCrystal®topicalbioadhe- sivetechnology.
STATUS Q1InDecember,Camurus’partnerSolasiaPharmasignedanagreementwithMeijiSeikaPharmaforcommercializationofepisil®inJapan.MarketregistrationprocessesareongoinginJapanandChina.Duringtheperiod,CamurussignedanagreementwithEthypharmforthedistributionofepisil® in France.IntheUS,Camuruspartner,R-Pharmcontinueslaunchingofepisil®, with initial focus on breast cancer patients.
O P E R AT I O N A L O V E R V I E W
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REVENUESRevenuesduringthequarteramountedtoMSEK17.2(20.2),generatedfromlicenseagreements,projectactivitiesandproductsales.
OPERATING RESULTMarketing,businessdevelopmentanddistributioncostsduringthequarter,wereMSEK7.1(4.3).
AdministrativeexpensesamountedtoMSEK4.4(3.7).R&Dcosts,includingdepreciationandamortizationof
tangibleandintangibleassetswereMSEK54.1(35.4).Otheroperatingexpensesmainlyconsistofcurrency
exchangelossesinoperationalactivities,wereMSEK0.1(1.7).TheoperatingresultforthequarterwasMSEK-51.6(-24.9).
FINANCIAL ITEMS AND TAX FinancialitemsfortheperiodwasMSEK-0.0(-0.0).
TaxwasMSEK11.3(5.5)andismainlyattributabletodeferredtaxforlossesduringthequarter.
RESULT FOR THE PERIODTheresultfortheperiodwasMSEK-40.2(-19.4),correspon-dingtoearningspershareofSEK-1.08(-0.52)beforeandafterdilution.
CASH FLOW AND INVESTMENTSCashflowfromoperatingactivities,beforechangeinworkingcapital,wasnegativeandamountedtoMSEK-50.6(-34.0).
Changeinworkingcapitalaffectedthecashflowpositively byMSEK7.0(-110.1)andthedifferencerelatestothepaymentinJanuary2016ofwithheldtaxandsocialsecuritycostsfortheshare-basedbonusprogram,whichwaseffectuatedinconnectionwiththelistingoftheCompany'ssharesonNasdaq StockholminDecember2015.
CashflowfrominvestingactivitieswasMSEK-1.2(-0.1).
CASH TheCompany'scashpositionasofMarch31,2017,wasMSEK463.8(571.9).Thedifferencecomparedtopreviousyearismainlyattributabletotheoperatingresult.
TherewerenooutstandingloansasofMarch31,2017,andnoloanshavebeentakenupsince.
EQUITYConsolidatedequityasofMarch31,20167wasMSEK524.2(621.1).
ACQUISITIONSAsapartoftheestablishmentoftheEuropeancommercialorganization,awhollyownedsubsidiaryhasbeensetupinUK.
FINANCIAL OVERVIEW
CAMURUS’ SHARECamurus’shareislistedonNasdaqStockholmsincetheDecember3,2015.Attheendoftheperiod,thetotalnumberofsharesinthecompanywas37,281,486(37,281,486).
InaccordancewithadecisionbyaShareholder’sGeneral MeetinginMay2016,anincentiveprogram(TO2016/2019)underwhichamaximumof550000warrantscanbeissued,wasintroduced.Thedilutionofafullutilizationoftheprogramcorrespondsto1.5%ofthesharecapitalandvotingrights.Thenumberofwarrantsthathavebeenissuedare550000andwhichgivetherighttosubscribeforanequalnumberofsharesduringtheperiodMay15,2019-December15,2019.Duringthequarter,nowarrantshavebeensubscribedforandasbyendofMarch31,2017,404300warrantshadbeensubscribedforintotal.
PARENT COMPANYRevenuesforthequarteramountedtoMSEK17.3(20.0)andtheresultaftertaxwasMSEK-39.9(-19.0).
OnMarch31,2017,equityintheParentCompanyamountedtoMSEK507.1(603.6).
TotalassetsattheendoftheperiodwasMSEK584.6(661.4)ofwhichMSEK463.6(571.9)werecashandcashequivalents.
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PERSONNELAttheendoftheperiod,Camurushad64(49)employees,ofwhom47(36)werewithinresearchanddevelopment.Thefull timeequivalentemployees(FTEs)duringthequarterwas59(48).
SIGNIFICANT RISKS AND UNCERTAINTIESThecompanymanagementmakesestimatesandassumptions aboutthefuture.Suchestimatescandeviateconsiderablyfrom the actual outcome, since they are based on various assumptionsandexperiences.
Theestimatesandassumptionsthatmayleadtotheriskofsignificantadjustmentstoreportedamountsforassetsand liabilities relate mainly to measurement and allocation of revenuesandcostsinconnectionwithlicensingagreementsanddeferredtaxreceivables.
Risksinongoingdevelopmentprojectscomprisetechnical andmanufacturingrelatedrisks(includingproductsfailingtomeetsetspecificationspostmanufacturing),safetyandeffect-relatedrisksthatcanariseinclinicaltrials,regulatoryrisksrelatingtonon-approvalordelaysofclinicaltrialappli-cationsandmarketapprovals,andcommercialrisksrelatingtothesaleofproprietaryandcompetingproductsandtheirdevelopmentonthemarket,aswellasIPrisksrelatingto approvalofpatentapplicationsandpatentprotection.In addition,therearerisksrelatingtothedevelopment,strategyandmanagementdecisionsofCamurus’partners.Camuruspursuesoperationsanditsbusinessontheinter- nationalmarketandtheCompanyisthereforeexposedto currencyrisks,sincerevenuesandcostsariseindifferent currencies,mainlySEK,EURandUSD.
TheBoardofDirectorshasnotchangeditsoutlookonfuturedevelopmentsinrelationtotheiroutlookpublishedintheannualreportfor2016.
OTHER DISCLOSURES
ANNUAL GENERAL MEETING 2017CamurusAnnualGeneralMeeting2017willbeheldon Wednesday3May,at17.00CET,atEliteHotelIdeon, Scheelevägen27,IdeonSciencePark,22363Lund.
AUDITThisreporthasnotbeenreviewedbythecompany’s auditors.
FURTHER INFORMATIONFor further information, please contact: FredrikTiberg,ChiefExecutiveOfficerReinPiir,VPInvestorRelationsTel.:+46462864692,e-mail:[email protected].
Lund, May 3, 2017Camurus AB
Board of Directors
Financial statements
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CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
2017 2016 2016 KSEK Note Jan – March Jan – March Jan – Dec
Netsales 3 17,192 20,246 113,737Costofgoodssold -32 -63 -2,140Gross profit 17,161 20,183 111,597
Marketinganddistributioncosts -7,093 -4,298 -24,738Administrativeexpenses -7,412 -3,715 -17,985Researchanddevelopmentcosts -54,143 -35,394 -172,077Otheroperatingincome – 16 751Otheroperatingexpenses -101 -1,650 –Operating result -51,588 -24,857 -102,452
Financeincome 1 2 95Financeexpenses -3 -37 -1,002Net financial items -2 -35 -907
Result before tax -51,590 -24,893 -103,359
Incometax 8 11,343 5,476 22,367Result for the period -40,247 -19,416 -80,993
Totalcomprehensiveincomeisthesameastheresultfortheperiod,astheconsolidatedgroupcontainsnoitemsthat arerecognizedunderothercomprehensiveincome.Totalcomprehensiveincomeisattributabletoparentcompany shareholders
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Presently,thecompanyhasonesubscriptionwarrantprogramactive.Forfurtherinformationseepage8,Camurus’share.
EARNINGS PER SHARE, based on earnings attributable to parent company shareholders for the period (in SEK per share)
2017 2016 2016 SEK Jan – March Jan – March Jan – Dec
Earningspersharebeforedilution,SEK -1,08 -0,52 -2,17Earningspershareafterdilution,SEK -1,08 -0,52 -2,17
F I N A N C I A L S TAT E M E N T S
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CONSOLIDATED BALANCE SHEET
KSEK Note 31-03-2017 31-03-2016 31-12-2016
ASSETSFixed assets
Intangible assetsCapitalizeddevelopmentexpenditure 18,219 20,303 18,741
Tangible assetsEquipment 10,463 6,450 9,759
Financial assetsLong-termreceivablesGroupcompanies – – –Deferredtaxreceivables 8 73,027 44,794 61,685Total fixed assets 101,710 71,546 90,185
Current assets
InventoriesFinishedgoods,rawmaterialsandproductsinwork 8,251 3,157 12,380
Current receivablesReceivablesfromGroupcompanies – – –Tradereceivables 6,689 14,170 8,304Otherreceivables 5,459 6,015 3,855Prepaymentsandaccruedincome 11,681 9,381 16,459Total current receivables 5 23,829 29,566 28,618
Cash and cash equivalents 463,804 571,916 508,594Total current assets 495,884 604,640 549,592TOTAL ASSETS 597,593 676,186 639,776
KSEK Note 31-03-2017 31-03-2016 31-12-2016
EQUITYEquity attributable to parent companyshareholderSharecapital 932 932 932Othercontributedcapital 631,034 626,181 631,034Retainedearnings,includingresultfortheperiod -107,797 -5,972 -67,549Total equity 9 524,170 621,141 564,418
LIABILITIESLong-term liabilitiesDeferredtaxliability – – –Total long-term liabilities – – –
Short-term liabilitiesLiabilitiestoGroupcompanies – – –Tradepayables 13,053 7,566 17,560Incometaxes – – –Otherliabilities 6,225 3,890 2,571Accruedexpensesanddeferredincome 54,145 43,589 55,228Total short-term liabilities 73,424 55,045 75,358TOTAL EQUITY AND LIABILITIES 597,593 676,186 639,776
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CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
Retained earnings, Other including Share contributed result for the TotalKSEK Note capital capital period equity
Opening balance 1 January 2016 932 626,181 13,444 640,557Resultfortheperiodandcomprehensiveincome -19,416 -19,416
Transactions with shareholders – – – –Closing balance 31 Mars 2016 932 626,181 -5,972 621,141
Opening balance 1 January 2016 932 626,181 13,444 640,557Resultfortheperiodandcomprehensiveincome -80,993 -80,993
Transactions with shareholdersWarrantsissued 4,853 4,853Closing balance 31 December 2016 932 631,034 -67,549 564,418
Opening balance 1 January 2017 932 631,034 -67,549 564,418Resultfortheperiodandcomprehensiveincome -40,248 -40,248
Transactions with shareholdersWarrantsissued – – – –Closing balance 31 March 2017 9 932 631,034 -107,797 524,170
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CONSOLIDATED STATEMENT OF CASH FLOW
2017 2016 2016 KSEK Note Jan – March Jan – March Jan – Dec
Operating activitiesOperatingprofit/lossbeforefinancialitems -51,588 -24,857 -102,452Adjustmentsfornon-cashitems 7 1,013 840 3,524Interestreceived 1 2 95Interestpaid -3 -37 -1,002Incometaxespaid – -9,917 -9,917 -50,577 -33,969 -109,752
Increase/decreaseininventories 4,129 84 -9,139Increase/decreaseintradereceivables 1,616 -5,253 613Increase/decreaseinothercurrentreceivables 3,174 5,923 1,005Increase/decreaseintradepayables -4,507 -24,266 -14,272Increase/decreaseinothercurrentoperatingliabilities 2,569 -86,564 -76,243Cash flow from changes in working capital 6,981 -110,076 -98,036Cash flow from operating activities -43,596 -144,045 -207,788
Investing activitiesAcquisitionofintangibleassets – – –Acquisitionoftangibleassets -1,195 -135 -4,567Divestment/amortizationofotherfinancialassets – – –Increase/decreaseincurrentfinancialinvestments – – –Cash flow from investing activities -1,195 -135 -4,567
Financing activitiesIncrease/decreaseincurrentfinancialliabilities – – –Warrantsissued – – 4,853Cash flow from financing activities – – 4,853
Net cash flow for the period -44,791 -144,180 -207,502Cashandcashequivalentsatbeginningofperiod 508,594 716,096 716,096Exchangeratedifferencesincashequivalents – – –Cash and cash equivalents at the end of period 463,804 571,916 508,594
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INCOME STATEMENT – PARENT COMPANY
2017 2016 2016 KSEK Note Jan – March Jan – March Jan – Dec
Netsales 17,337 20,246 113,737Costofgoodssold -32 -63 -2,140Gross profit 17,305 20,183 111,597
Marketinganddistributioncosts -7,232 -4,298 -24,738Administrativeexpenses -7,555 -3,715 -17,985Researchanddevelopmentcosts -53,621 -34,873 -169,994Otheroperatingincome – 16 751Otheroperatingexpenses -101 -1,650 –Operating result before items affecting comparability -51,204 -24,337 -100,370
ResultfrominterestsinGroupcompanies – – –Interestincomeandsimilaritems 1 2 95Interestexpenseandsimilaritems -3 -37 -1,002Result after financial items -51,206 -24,372 -101,277
Appropriations – – -1,246Result before tax -51,206 -24,372 -102,523
Taxonprofitfortheperiod 8 11,265 5,362 22,183Result for the period -39,941 -19,010 -80,340
Totalcomprehensiveincomeisthesameasprofit/lossfortheperiod,astheparentcompanycontains noitemsthatarerecognizedunderothercomprehensiveincome.
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BALANCE SHEET – PARENT COMPANY
KSEK Note 31-03-2017 31-03-2016 31-12-2016
ASSETSFixed assets
Tangible fixed assetsEquipment 10,463 6,450 9,759
Financial fixed assetsInterestinGroupcompanies 816 573 816Deferredtaxassets 8 77,839 49,753 66,574Total fixed assets 89,118 56,775 77,149
Current assets
InventoriesFinishedgoods,rawmaterialsandproductsinwork 8,251 3,157 12,380
Current receivablesReceivablesfromparentcompany – – –Tradereceivables 6,689 14,170 8,304Otherreceivables 5,244 6,015 3,855Prepaymentsandaccruedincome 11,681 9,383 16,459Total current receivables 23,614 29,568 28,618
Cash and bank deposits 463,566 571,916 508,351Total current assets 495,431 604,642 549,351TOTAL ASSETS 584,549 661,417 626,499
KSEK Note 31-03-2017 31-03-2016 31-12-2016
EQUITY AND LIABILITIESRestricted equityRestrictedequity(37281486shares) 932 932 932Statutoryreserve 11,327 11,327 11,327Total restricted equity 12,259 12,259 12,259
Unrestricted equityRetainedearnings -62,595 17,746 17,746Sharepremiumreserve 597,418 592,565 597,418Resultfortheperiod -39,941 -19,010 -80,340Total unrestricted equity 494,883 591,300 534,823
TOTAL EQUITY 507,142 603,560 547,083
LIABILITIESUntaxed reservesrDepreciation/amortizationinexcessofplan 3,486 2,239 3,486Total untaxed reserves 3,486 2,239 3,486
Long-term liabilitiesLiabilitytosubsidiaries 1,945 573 573Total long-term liabilities 1,945 573 573
Short-term liabilitiesLiabilitiestoGroupcompanies – – –Tradepayables 13,053 7,566 17,560Currenttaxliability – – –Otherliabilities 5,130 3,890 2,571Accruedexpensesanddeferredincome 53,793 43,589 55,227Total short-term liabilities 71,976 55,045 75,358TOTAL EQUITY AND LIABILITIES 584,549 661,417 626,499
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KEY FIGURES AND DEFINITIONS
Cash and cash equivalentsCashandcashbankbalances
Equity ratio, % Equitydividedbytotalcapital
Average number of shares, before dilutionWeightedaveragenumberofsharesbeforeadjustmentfordilutioneffectofnetshares
Average number of shares, after dilutionWeightedaveragenumberofsharesadjustmentfor the dilution effectofnewshares
Earnings per share before dilution, SEKResultdividedbytheweightedaverage numberofsharesoutstandingbeforedilution
Earnings per share after dilution, SEKResultdividedbytheweightedaverage number ofsharesoutstandingafterdilution
Equity per share before dilution, SEKEquitydividedbytheweightednumber of shares at the period before dilution
Equity per share after dilution, SEKEquitydividedbytheweightednumberof shares at the end of the period after dilution
R&D costs as a percentage of operating expensesResearch and development costs divided by operatingexpenses,excludingitemsaffectingcomparability(marketingand distribution costs,administrativeexpensesandresearch anddevelopmentcosts)
2017 2016 2016 Key figures, MSEK Jan – March Jan – March Jan – Dec
Netrevenues 17,2 20,2 113,7Operatingresult -51,6 -24,9 -102,5Result for the period -40,2 -19,4 -81,0Cashflowfromoperatingactivities -43,6 -144,0 -207,8Cashandcashequivalents 463,8 571,9 508,6Equity 524,2 621,1 564,4EquityratioinGroup,percent 88% 92% 88%Totalassets 597,6 676,2 639,8Averagenumberofshares,beforedilution 37281486 37281486 26281486Averagenumberofshares,afterdilution*) 37685786 37281486 37487937Earningspersharebeforedilution,SEK -1,08 -0,52 -2,17Earningspershareafterdilution,SEK*) -1,08 -0,52 -2,17Equitypersharebeforedilution,SEK 14,06 16,66 15,14Equitypershareafterdilution,SEK*) 13,91 16,66 15,06Numberofemployeesatendofperiod 64 49 62NumberofemployeesinR&Datendofperiod 47 36 44R&Dcostsasapercentageofoperatingexpenses 79% 82% 80%
*) The dilution effect is calculated according to IAS 33
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Note 1 General information
CamurusAB,Corp.IDno.556667-9105istheparentcompany oftheCamurusGroup.CamurusAB’sregisteredofficesis basedinLund,Sweden,atIdeonSciencePark,22370Lund.CamurusABGroup’sinterimreportforthefirstquarter2017was approved for publication in accordance with a decision fromtheBoardonMay3,2017.
AllamountsarestatedinSEKthousand(KSEK),unlessotherwiseindicated.Figuresinbracketsrefertotheyear-earlier period.
Note 2 Summary of key accounting policies
TheconsolidatedfinancialstatementsfortheCamurusABGroup(‘Camurus’)havebeenpreparedinaccordancewithInternationalFinancialReportingStandards(IFRS)asadoptedbytheEU,aswellastheSwedishFinancialReportingBoard’sRecommendationRFR1SupplementaryAccountingRulesforGroups,andtheSwedishAnnualAccountsAct.
ThisinterimreporthasbeendrawnupinaccordancewithIAS34,InterimFinancialReporting,theSwedishAnnualAccountsActandRFR1SupplementaryAccountingRules forGroups.
TheparentcompanystatementshavebeenpreparedinaccordancewiththeAnnualAccountsActandrecommen-dationRFR2AccountingforlegalentitiesfromtheSwedishFinancialReportingBoard.TheapplicationofRFR2meansthattheparentcompanyintheinterimreportforthelegalentityshallapplyallEU-approvedIFRSstandardsandstate-mentsasfaraspossiblewithintheframeworkoftheAnnualAccountsAct,thePensionObligationsVestingAct(Trygg- andelagen)andtakingintoconsiderationtherelationship
betweenaccountingandtaxation.Theparentcompany’saccountingpoliciesarethesameasfortheGroup,unlessotherwisestatedinNote2.2.
Themostimportantaccountingpoliciesthatareappliedinthepreparationoftheseconsolidatedfinancialstatementsaredetailedbelow.
2.1 BASIS OF PREPARATION OF REPORTS2.1.1 Changes to accounting policies and disclosuresNeworrevisedIFRSstandardsthathavecomeintoforcehavenothadanymaterialimpactontheGroup.
2.2 PARENT COMPANY’S ACCOUNTING POLICIESTheparentcompanyappliesaccountingpoliciesthatdifferfromthoseoftheGroupinthecasesstatedbelow.
Internally generated intangible assetsAllexpensesthatrelatetothedevelopmentofinternallygeneratedintangibleassetsarerecognizedasexpensesastheyarise.
Interests in subsidiariesInterests in subsidiaries are reported at cost, less any impairmentlosses.Thecostincludesacquisition-relatedexpensesandanyadditionalconsiderations.
When there is an indication that interests in subsidiaries have decreased in value, a calculation is made of the recoverableamount.Ifthisamountislowerthanthereportedamount,animpairmentiscarriedout.Impairmentlossesarerecognizedundertheitem“ResultfrominterestsinGroupcompanies”.
Group contributionsGroupcontributionspaidbytheparentcompanytosubsidi-ariesandGroupcontributionsreceivedfromsubsidiariesbytheparentcompanyarerecognizedasappropriations.
Financial instrumentsIAS39isnotappliedintheparentcompanyandfinancialinstrumentsaremeasuredatcost.
Share-based paymentWarrant program TO2016/2019PresentlyCamurushasonelong-termincentiveprogramactive.InaccordancewithadecisionbytheAnnualGeneralMeetinginMay2016,anincentiveprogram,TO2016/2019,forthecompany’semployees,underwhichamaximumof550,000warrantscanbeissued,wasintroduced.Thewarr-ants were valued by an independent institute in accordance withtheBlack&Scholesmodelandwereacquiredbythe participantsatmarketvalue.Aspartoftheprogram,theparticipantsreceiveathreepiecestay-onbonusintheformofgrosssalaryadditionfromthecompany,equivalenttotheamountpaidbytheparticipantforitssubscriptionwarrants.Asthestay-onbonusisconditionaloncontinuedemployment costs,includingsocialsecuritycost,areexpensedoverthevestingperiodandaliabilityiscalculatedateachbalancesheetdatebasedonhowmuchhasbeenearned.Expensesarerecognizedaspersonnelexpenseintheincomestate-ments.-basedpayment
NOTES
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N O T E S
RevenueduringthequarterofapproximatelyMSEK13.2(7.9)relatestoonesingleexternalcustomer.AllfixedassetsarelocatedinSweden.
Revenuesfromexternalcustomersisallocatedbycountry,basedonwherethecustomersarelocated.
2017 2016 2016 KSEK Jan – March Jan – March Jan – Dec
Europé 1,375 7,549 22,921(ofwhichSweden) (59) (1,673) (3,727)NorthAmerica 15,670 12,572 87,359Othergeographicalareas 147 125 3,457Total 17,192 20,246 113,737
2017 2016 2016 KSEK Jan – March Jan – March Jan – Dec
Salesofdevelopmentrelatedgoodsandservices 13,927 15,971 68,112Milestonepayments 2,205 – 34,217Licensingrevenues 835 4,275 8,485Other 225 – 2,923Total 17,192 20,246 113,737
Note 3 Segment information
Thehighestexecutivedecisionmakeristhefunctionrespon-sibleforallocatingresourcesandassessingtheoperatingsegmentsresults.IntheGroupthisfunctionisidentifiedastheCEObasedontheinformationhehandles.Asthebusiness, i.e.thedevelopmentofpharmaceuticalproductsbasedonCamurus’technologyplatform,theGroupisorganizedasanintegratedunit,withsimilarrisksandopportunitiesfortheproductsandservicesproduced,theentireGroup'sbusiness constitutesoneoperatingsegment.Theoperatingsegment are monitored in a manner consistent with the internal reportingprovidedtothechiefoperatingdecisionmaker.IntheinternalreportingtotheCEO,onlyonesegmentisused.results.
Group-wide informationTofollowisabreakdownofrevenuesfromallproductsandservices.
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Note 4 Earnings per share
a) Before dilutionEarningspersharebeforedilutioniscalculatedbydividingthe result attributable to shareholders of the parent company byaweightedaveragenumberofordinarysharesoutstanding duringtheperiod.Duringtheperiod,nosharesheldastreasurysharesbytheparentcompanyhavebeenrepurchased.
b) After dilutionInordertocalculateearningspershare,thenumberofexisting ordinarysharesisadjustedforthedilutiveeffectoftheweightedaveragenumberofoutstandingordinaryshares.Theparentcompanyhasonecategoryofordinaryshareswithanticipateddilutioneffectintheformofwarrants.Forwarrants, a calculation is made of the number of shares that could have been purchased at fair value (calculated as the averagemarketpricefortheyearfortheparentcompany’sshares),atanamountcorrespondingtothemonetaryvalueofthesubscriptionrightslinkedtooutstandingwarrants.Thenumber of shares calculated as above is compared to the numberofsharesthatwouldhavebeenissuedassumingthewarrantsareexercised.
2017 2016 2016 KSEK Jan – March Jan – March Jan – Dec
Resultattributabletoparentcompanyshareholders -40,247 -19,416 -80,993Total -40,247 -19,416 -80,993
Weighted average number of ordinary shares outstanding (thousands) 37,281 37,281 37,281
2017 2016 2016 KSEK Jan – March Jan – March Jan – Dec
Resultattributabletoparentcompanyshareholders -40,247 -19,416 -80,993Total -40,247 -19,416 -80,993
Weighted average number of ordinary shares outstanding (thousands) 37,281 37,281 37,281Adjustments:
–warrants(thousands) 404 – 207–shareissues(thousands) – – –
Weighted average number of ordinary shares in calculation of 37,688 37,281 37,488 earnings per share after dilution (thousands)
N O T E S
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Note 5 Financial instruments – Fair value of financial assets and liability measured at amortized cost
AlloftheGroup’sfinancialinstrumentsthataremeasuredatamortizedcostareshort-termandexpirewithinoneyear. Thefairvalueoftheseinstrumentsisdeemedtocorrespondtotheirreportedamounts,sincediscountingeffectsareminimal.
Note 6 Related party transactions
Investorrelationsserviceshavebeenacquiredfrom Piir&PartnersAB,whoserepresentativeisamemberofthemanagementteam.Pricingisdoneinaccordancewithallocationofcostsinrelationtoutilizationrateandonmarketterms.AttheendoftheperiodthecompanyhadadebttoPiir&PartnerABregardingtheseservicesthatamountedtoMSEK0.3(0.2).
Carrying amount, KSEK 31-03-2017 31-03-2016 31-12-2016
Loans and receivablesTradereceivables 6,689 14,170 8,304ReceivablesfromGroupcompanies – – –Otherreceivables – – –Cashandcashequivalents 463,804 571,916 508,594Total 470,493 586,086 516,898
Other liabilitiesOtherfinancialliabilities – – –LiabilitiestoGroupcompanies – – –Tradepayables 13,053 7,566 17,560Othercurrentliabilities 191 191 191Total 13,244 7,757 17,751
N O T E S
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This information is information that Camurus AB is obliged to make public pursuant to the EU Market Abuse Regulation and the Swedish Securities Markets Act. The information was submitted for publication, through the agency of the chief executive officer, 13.00 PM CET on May 3, 2017.
Note 7 Other non-cash items
Adjustmentfornon-cashitems:
Note 8 Deferred tax
TaxforthequarteramountedtoMSEK11.3(5.5),primarilyattributabletothenegativeresult.
Note 9 Equity
Thechangeinequityforthequarterismainly attributabletotheloss.
N O T E S
2017 2016 2016 KSEK Jan – March Jan – March Jan – Dec
Depreciation 1,013 840 3,524Total 1,013 840 3,524
CamurusAB | IdeonSciencePark,SE-22370Lund,SwedenP+46462865730 | F+46462865739 | [email protected] | camurus.com