leo pharma | annual report · pdf fileleo pharma | annual report 2011 leo pharma a/s. ......
TRANSCRIPT
AnnualReport2011 3
CONTENTS
MANAGEMENT’SSTATEMENTANDAUDITOR’SREPORT
Management’sStatement 5IndependentAuditor’sReport 7
MANAGEMENT’SREVIEW
Companyinformation 85-yearfinancialhighlightsoftheGroup 9Management’sReview 11
FINANCIALSTATEMENTS1JANUARY–31DECEMBER
Accountingpolicies 25Incomestatement 35Balancesheet 36Cashflowstatement 39Notes 41Investmentsinaffiliates 54
PresentedandadoptedattheAnnualGeneralMeetingoftheCompanyon26March2012
CVR56759514
ThisAnnualReportisanextractoftheCompany’sstatutoryannualreportpursuanttoSection149oftheDanishFinancialStatementsAct.ThestatutoryannualreportwillbesubmittedtotheDanishBusinessAuthority,andacopymaybeobtainedviatheAuthority’swebsitewww.cvr.dk.
4 LEOPharma
Fromtheleft:
Anders B. SpohrExecutiveVicePresidentGlobalProductSupply
Lars OlsenExecutiveVicePresidentSalesandMarketing
Gitte P. AaboPresidentandCEO
Kim KjøllerSeniorVicePresidentGlobalDevelopment
Tore DuvoldSeniorVicePresidentNewProductDiscovery
GROUP MANAGEMENT2012
We help people achieve healthy skin
AnnualReport2011 5
TheBoardofDirectorsandtheBoardofExecutiveshave today considered and adopted the AnnualReportofLEOPharmaA/Sforthefinancialyear1January–31December2011.
TheAnnualReporthasbeenpreparedinaccordancewiththeDanishFinancialStatementsAct.
In our opinion, the Consolidated Financial State-mentsandtheParentCompanyFinancialStatementsgiveatrueandfairviewofthefinancialpositionat31December2011oftheGroupandtheCompanyandoftheresultsoftheGroup’sandtheCompany’s
operations and consolidated cashflows for 2011.
Inouropinion,Management’sReviewincludesatrueand fair account of the development in the oper-ationsandfinancialcircumstancesoftheGroupandtheCompany,oftheresultsfortheyearandofthefinancialpositionoftheGroupandtheCompanyaswellasadescriptionofthemostsignificantrisksandelements of uncertainty facing theGroup and theCompany.
WerecommendthattheAnnualReportbeadoptedattheAnnualGeneralMeeting.
MANAGEMENT’S STATEMENT
GitteP.Aabo LarsOlsen AndersB.Spohr President,CEO
Ballerup,26March2012
Board of Executives
Board of Directors
PoulRødbroeRasmussen Chairman
KarinAttermann JannieKogsbøll LotteHjortshøjLarsen
PederHolkNielsen JensBoOlesen JukkaPertola
JanRasmussen PerHåkonSchmidt GormM.Thamsborg
AnnualReport2011 7
Auditor’s Report on the Consolidated Financial Statements and the Parent Foundation Financial Statements WehaveauditedtheConsolidatedFinancialState-mentsandtheParentCompanyFinancialStatementsofLEOPharmaA/Sforthefinancialyear1January–31December2011,whichcompriseincomestate-ment,balancesheet,notesandaccountingpoliciesforboththeGroupandtheParentCompany,aswellasconsolidatedcashflowstatement.TheConsoli-datedFinancialStatementsandtheParentCompa-nyFinancialStatementsarepreparedinaccordancewiththeDanishFinancialStatementsAct.
Management’s Responsibility for the Consolidated Financial Statements and the Parent Company Financial StatementsManagement is responsible for thepreparationofConsolidatedFinancialStatementsandParentCom-panyFinancialStatementsthatgiveatrueandfairviewinaccordancewiththeDanishFinancialState-mentsAct, and for such internal control asMan-agement determines is necessary to enable thepreparation of Consolidated Financial StatementsandParentCompanyFinancialStatementsthatarefree frommaterialmisstatement,whetherdue tofraudorerror.
Auditor’s Responsibility Ourresponsibility istoexpressanopinionontheConsolidated Financial Statements and the Par-ent Company Financial Statements based on ouraudit.Weconductedouraudit inaccordancewithInternationalStandardsonAuditingandadditionalrequirementsinaccordancewithDanishauditreg-ulation.Thisrequiresthatwecomplywithethicalrequirements and plan and perform the audit toobtainreasonableassurancewhethertheConsoli-datedFinancialStatementsandtheParentCompanyFinancial Statements are free frommaterialmis-statement.
Anaudit involvesperformingaudit procedures toobtainauditevidenceabouttheamountsanddis-closures intheConsolidatedFinancialStatements
andtheParentCompanyFinancialStatements.Theauditproceduresselecteddependontheauditor’sjudgement,includingtheassessmentoftherisksofmaterialmisstatementof theConsolidatedFinan-cialStatementsandtheParentCompanyFinancialStatements,whetherduetofraudorerror.Inmak-ingthoseriskassessments, theauditorconsidersinternalcontrolrelevanttotheCompany’sprepara-tionofConsolidatedFinancialStatementsandPar-entCompanyFinancialStatementsthatgiveatrueand fairview inorder todesignauditproceduresthatareappropriateinthecircumstances,butnotfor the purpose of expressing an opinion on theeffectivenessoftheCompany’sinternalcontrol.AnauditalsoincludesevaluatingtheappropriatenessofaccountingpoliciesusedandthereasonablenessofaccountingestimatesmadebyManagement,aswellasevaluatingtheoverallpresentationoftheConsoli-datedFinancialStatementsandtheParentCompanyFinancialStatements.
Webelievethattheauditevidencewehaveobtainedissufficientandappropriatetoprovideabasisforourauditopinion.
Theaudithasnotresultedinanyqualification.
OpinionIn our opinion, the Consolidated Financial State-mentsandtheParentCompanyFinancialStatementsgiveatrueandfairviewofthefinancialpositionoftheGroupandtheCompanyat31December2011andoftheresultsoftheGroup’sandtheCompany’soperationsaswellastheconsolidatedcashflowsforthefinancialyear1January–31December2011inaccordancewiththeDanishFinancialStatementsAct.
Statement on Management’s Review
WehavereadManagement’sReviewinaccordancewiththeDanishFinancialStatementsAct.Wehavenot performed any procedures additional to theauditoftheConsolidatedFinancialStatementsandtheParentCompanyFinancialStatements.Onthisbasis, inouropinion, the informationprovided inManagement’sReviewisconsistentwiththeConsoli-datedFinancialStatementsandtheParentCompanyFinancialStatements.
Kim Füchsel StateAuthorisedPublicAccountant
Lars BaungaardStateAuthorisedPublicAccountant
INDEPENDENT AUDITOR’S REPORT
To the Shareholder of LEO Pharma A/S
Copenhagen,26March2012PricewaterhouseCoopersStatsautoriseretRevisionspartnerselskab
8 LEOPharma
MANAGEMENT’S REVIEW
Company information
Company LEOPharmaA/S Industriparken55
2750Ballerup Denmark
Telephone:+4544945888 Fax:+4572263321 Website:www.leo-pharma.com E-mail:www.leo-pharma.com/contact CVRNo:56759514 Founded:1908 Reg.office:Ballerup Financialyear:1January–31December
Board of PoulRødbroeRasmussen,ChairmanDirectors KarinAttermann JannieKogsbøll LotteHjortshøjLarsen PederHolkNielsen JensBoOlesen JukkaPertola JanRasmussen PerHåkonSchmidt GormM.ThamsborgBoard of GitteP.Aabo,President,CEOExecutives LarsOlsen AndersB.Spohr
Auditors PwC Strandvejen44 2900Hellerup Denmark
AnnualReport2011 9
5-YEAR FINANCIAL HIGHLIGHTS OF THE GROUP
2011 2010 2009 2008 2007 DKKmillion DKKmillion DKKmillion DKKmillion DKKmillion
Income statement Revenue 7,741 7,245 6,082 5,709 5,246OfwhichoutsideDenmark 7,492 7,033 5,763 5,400 4,937Operatingprofit/loss 158 177 -876 2,464 2,318Netfinancials 838 887 857 737 583Profit/lossbeforetax 996 1,064 -19 3,201 2,901
Net profit/loss for the year 624 700 -167 2,528 2,365
Balance sheetNetinvestmentin: Intangibleassets 0 0 6,266 0 0Property,plantandequipment 410 541 284 141 184
Fixedassets 24,600 23,486 26,560 20,761 17,777Currentassets 4,364 3,805 7,706 3,624 2,794
Total assets 28,964 27,291 34,266 24,385 20,571
Equity 21,426 20,833 20,096 20,321 17,832
Ratios Profitmargin 2% 2% -14% 43% 44%Returnonassets 1% 1% -3% 11% 11%Returnonequity 5% 5% 0% 17% 17%Solvencyratio 74% 76% 59% 83% 87%
Employees Averagenumberofemployees 4,391 3,796 3,278 3,008 2,921
AnnualReport2011 11
2011marksLEOPharma’ssecondfullfinancialyearsincethelaunchoftheGroup’sgrowthstrategy.Theoverallobjectiveof thestrategy is todevelopandstrengthenLEOPharma’sposition–bothinnewandestablishedmarkets–byofferingmore treatmentoptionsandthroughcontinuousdevelopmentofcom-petencesamongtheGroup’semployees.
Consequently,considerableinvestmentsweremadeintheseareasin2011.Thedevelopmentandlaunchofnewtreatmentoptionswereintensifiedand,bytheendoftheyear,LEOPharmawasactivein61countries.Thenumberofemployeesaveraged4,391in2011,comparedto3,796in2010.
In2011,LEOPharmareviseditsbusinessstrategy.Amongotherthings,thisledtoanewmissionandvisionwhichclearlyreflecttheGroup’sglobalcom-mitmenttowardspeoplesufferingfromskincondi-tions.Withitsnewvisionandmission,LEOPharma
wantstomakesurethatthesepatientsgetaccesstomoreandimprovedtreatmentoptions.
TherevisedbusinessstrategywaslaunchedintheformoftheLEO powerhouseinJune2011.Inaddi-tiontoLEOPharma’smissionandvision,theLEOpowerhouseincludestheGroup’slong-termsuccesscriteriaandfivestrategicfocusareas:theso-calledcorporate Must-Win Battles.TheLEOpowerhouseisbuiltonsolidfoundationsconsistingoftheGroup’svaluesandguidelinesforhowleadersandemployeesshouldinteractanddevelop.
Results of strategic initiatives in 2011ThefivecorporateMust-WinBattlesensurethatweoptimiseourprioritisationoftheGroup’sresourcesintheefforttoachieveouroverallgrowthtargets.Allfivefocusareasshowedpositiveresultsin2011,asdescribedbelow.
MANAGEMENT’S REVIEW
LEO mission
We help peopleachieve healthy skin.
LEO vision
We are the preferred dermatology care partner improving people’s lives around the world.
12 LEOPharma
Peopledevelopmentsessions(PersonalDevelopmentDialogue,PDD)wereintroducedforallemployeesinDenmark.Thistoolwillberolledouttotherestoftheorganisationin2012.
Top115leaderscompletedtheGrowingLEOLeadershipprogrammeatIMDinSwitzerland.
ThemanagementdevelopmentprogrammeGrowingLEOLeaders,whichnumbers470leadersworldwide,wasintroducedin2011.
TheglobalintranetPulsewaslaunchedinordertoestablishajointcommunicationchannelandaplatformforknowledge-sharingforallLEOemployees.
MarketingapplicationsrelatingtoPicato®forthetreatmentofactinickeratosiswerefiledintheUSA,Europe,AustraliaandBrazil,andLEOPharmapassedsevenFDAinspections.
Anumberofinitiativeswereintroducedtoensurepatient-centredcare,includinganewGlobalPatientEngagementdepartment,integratedcareprogrammes,PeopleBox(internalinformationprovidingemployeeswithaninsightintoandunderstandingofthechallengesfacingpatients)aswellasMoments,thepsoriasiscommunicationplatform.
Grosssalesofstrategicpsoriasisproductsincreasedby21%comparedto2010.
ThemarketingapplicationrelatingtoPicato®wasfiledwiththeBrazilianauthorities.
AnindependentfunctionfocusingonbusinessdevelopmentwassetupinChina.
DERMATOLOGY – EXPANDING OUR FOOTPRINT
GROWING PEOPLE, GROWING LEO
NEW MARKETS – FUTURE OPPORTUNITIES
DERMATOLOGY– EXPANDING OUR
FOOTPRINT
2015
GROWING PEOPLE, GROWING LEO
NEW MARKETS – FUTURE
OPPORTUNITIES
AnnualReport2011 13
Aclearstrategywasimplementedforinnohep®forthetreatmentofthrombosis:
TheSYRIUSprojectwasinitiated,theobjectiveofwhichistosecurethedeliveryofpre-filledsyringesfortheUSmarket.
CATCH,thelargestclinicalstudyeverinLEOPharma’shistory,aimstoprotectcancerpatientsagainstvenousthrombosisthroughtreatmentwithinnohep®.
innohep®grosssalesincreasedby9%comparedto2010.
10%revenuegrowthontheUSmarketmeasuredinDanishkroner.
ThenumberofemployeesintheUSAincreasedfrom33in2010to194in2011.
AnextendedLEOQualityCare™programmewasintroducedtoensurethecorrectuseofdrugsbypatients.
ThemarketingapplicationrelatingtoPicato®forthetreatmentofactinickeratosiswasfiledwiththeUSFoodandDrugAdministration(FDA).
INNOHEP® – FULL SPEED AHEAD!
USA – YES, WE WILL!
innohep®
– FULL SPEED AHEAD!
USA– YES, WE WILL!
14 LEOPharma
In 2011, LEOPharmaextended its focus area toincludetheindicationactinickeratosis,andsotheGroup’sstrategictherapyareasnowconsistofthefollowing:
DERMATOLOGY
PsoriasisEczemaSkininfectionsActinickeratosis
In2011,thestrategicproductswithindermatol-ogycomprisedDaivobet®(psoriasis)andXamiol®(psoriasis).In2012,LEOPharmawillextenditsstrategicdermatologyportfoliowithPicato®(actinickeratosis),whichhasbeenapprovedbytheFDAandwillbelaunchedintheUSAinMarch2012.Thetargetisfor50,000patientstobereceivingtreatmentwithPicato®bytheendof2012.LEOPharmaexpectstoobtainapprovalforPicato®intheEU,BrazilandAustraliain2013.
THROMBOSIS
Thestrategicproductfortheindicationthrombosisisinnohep®.
STRATEGIC PRODUCTS
AnnualReport2011 15
LEOPharma’srevenuefortheyearinDanishkro-ner increased by 7% in 2011.Measured in fixedexchangerates,growthtotalled7%in2011.LEOPharma’s gross salesmeasured in Danish kronerincreasedby9%in2011comparedto2010.
IncreasedsalesoftheGroup’spsoriasisproductscontributed to LEO Pharma’s growth, especiallyintheUSmarket.RevenueintheUSAincreasedby10%measuredinDanishkronercomparedto2010.TheUSAgenerated20%ofLEOPharma’stotal revenue in2011. Looking forward, theUSaffiliateisexpectedtocontinueitssignificantcon-tributiontogrowthwithintheareaofdermatol-ogy.RevenuegrowthmeasuredinDanishkroneroutsidetheUSAincreasedby3%inEuropeandby18% in the rest of theworld. LEOPharma’sgrowthin2011wasprimarilydrivenbythestrate-gicproductsDaivobet®,Xamiol®andinnohep®.Asaresult,measuredinDanishkroner,grosssalesofDaivobet®increasedby19%,Xamiol®by30%andinnohep®by9%.
In 2011, we launched Daivobet® Gel in France,theUK, theNetherlands,Belgiumand theNordiccountriesotherthanDenmark.Daivobet®GelsalestotalledDKK209millionin2011.
Several new unitsIn2011,theGroupcontinueditsmarketexpansionbysettingupaffiliates inAustraliaand Italy,andestablishments in SouthKorea and Indonesia. InAustralia,werepurchasedtherightstoourpsoriasisportfolioon1June2011.
Moreover, with effect from 1 January 2012, LEOPharmahasrepurchasedtherightstoourpsoriasisportfolioinItalyandpartsofourpsoriasisportfolioinGermanyandAustria.
Satisfaction despite the financial crisisThesalesgrowthfor2011isconsideredsatisfac-tory,despitetheadverseeffectonrevenuecausedbyseveralnegativefactors.Asaresultoftheglobalfinancialcrisis,LEOPharmahadtoincreasecom-pulsorydiscountsin2011comparedto2010duetothetighteningofEuropeanhealthbudgets.LEOPharma’stotaldiscountsasapercentageofgrosssalesincreasedby1%orDKK71million.
ThefinancialcrisisinGreeceresultedinasignificantdecreaseinsales,particularlysalesof innohep®.Thisisprimarilyduetothefactthat,asaconse-quenceofthecrisisandconsiderablebaddebtsin
FINANCIAL RESULTS FOR 2011
Iberia5% LEO DE
4%
LEO US22%
LPI 20%
France-Magreb20%
North Atlantic17%
Nordic-Benelux12%
FORDELING AF TOTALT SALG
LEO CODE OF CONDUCT
GxP Non-GxP
Group PoliciesGroup Guidelines
SOPs
Analytical Methods Test Methods
Work Instructions
Strategiclevel
Operationallevel
8,000
6,000
4,000
2,000
0
7% compared to 2010
7%
NET SALES YEAR-TO-DATE AT ACTUAL RATES
20102011
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
DKK million
16 LEOPharma
2010,theGrouphadtotightenthepaymenttermsforGreekhospitals.
Voluntary recall of innohep®
InMarch2011,LEOPharmadecidedtorecallinno-hep®vialsintheUSAfollowingadialoguewiththeFDA. The recall took place because the FDA hadexpressed concern over a theoretical risk of thepresenceofparticulatematterinvialsreleasedintheUSA,andwasnotthereforelinkedtoanyinci-dencesofadverseeventsorcustomercomplaints.Therewerenoothersignificantrecallsin2011.
Supplies affected by a fireIn2011,saleswere,toaminorextent,affectedbysupplyproblemsfollowingafactoryfireinDenmarkand production difficulties in France. After rapidandfocusedefforts,productionisrunningsmoothlyagain.
Investments in new employees Aspartofthegrowthstrategy,LEOPharmaiscur-rentlyincreasingstaffnumbersacrosstheglobalorganisation,resultinginincreasedexpenditure.In2011,theGrouptookonnet675newemployees,which isanet increaseof17%on thepreviousyear.
Inlinewithgrowthtargets,thenewemployeesaremainlyemployedinsalesandmarketingrolesinthenewlyestablishedmarkets.StaffexpensesrosefromDKK2,091millionin2010toDKK2,670millionin2011.
Increase in external expensesOtherexternalexpensesincreasedtoDKK3,595million from DKK 3,314 million in 2010. Theincreaseisprimarilyattributabletoincreasedsalesandmarketingexpenses,includinginvestmentsinnewmarketsandexpensesrelating to theprep-arationof thePicato® launch in2012.Moreover,aspreviouslycommunicated,LEOPharmaisplan-ningtoreplacesomeoftheGroup’sownproductionfacilitieswithincreasedoutsourcing.AprovisionofDKK46millionwasmadein2011toimplementthischange.
Satisfactory resultsTheprofitbeforetaxwasnegativelyaffectedbyamor-tisationofintellectualpropertyrightsinrespectofPica-to®relatingtotheacquisitionofPeplin,Inc.in2009,aswellasamortisationrelatingtothere-acquisitionofdis-tributionrightsontheUSmarketin2009totallingDKK725million.Impairmentandamortisationofintellec-tualpropertyrightstotalledDKK1,168millionin2010.
TheGroup’snetfinancialincometotalledDKK838mil-lionin2011,comparedtoDKK887millionin2010.In2011,LEOPharmainvestedDKK410millioninprop-erty,plantandequipment.The investmentsmainlyrelatetoextendingtheGroup’sfactoriesinFranceandAustraliainordertoensureadequatecapacityforthefuturesalesgrowthforinnohep®andthelaunchofPicato®in2012,aswellastotheconstructionofanewofficebuildingattheBallerupheadquarters.
PositivecashflowofDKK1,820millionwasgener-atedfromoperatingactivitiesin2011.TheGroupachieveda5%returnonequityin2011and,attheendoftheyear,equitytotalledDKK21,426million.Basedontheseresults,LEOPharmaisentering2012withasolvencyratioof74%.
ThemarketvalueoftheGroup’sbondholdingswasDKK20,421millionattheendof2011.
Theresultsfor2011areinaccordancewithManage-ment’sexpectationsfortheyear,andarethereforeconsideredsatisfactory.
SPECIAL MATTERS
Theeffective tax rate for theLEOPharmaGroupchangedfrom34%in2010to37%in2011.Theprimaryreasonforthechangeisthat,inconnectionwiththeprocessofintegratingthePeplinactivities,LEOPharmasoldintangibleassetsbelongingtothePeplinGrouptoLEOLaboratoriesLtd,which trig-geredcapitalgainstaxforthePeplinGroup.
Compensation from lawsuitsLEOPharmareceivedcompensationofDKK70mil-lionin2011connectedtotwopatentlawsuits.Theamounthasbeenrecognisedasincomein2011aspartofotheroperatingincome.
FINANCIAL RESULTS FOR 2011
AnnualReport2011 17
Operating risksLEOPharma iscontinuallyworkingonensuringareasonablebalancebetweenriskexposureandvaluecreation.Therefore,we regularlyenter into long-termagreementsforthesupplyofrawmaterialsandothercriticalinputfortheGroup’sproduction.
Market risksLEOPharmamakesconsiderableeffortstoprotectitsintellectualpropertyrightsatalltimes,bothforexist-ingandfornewdrugs,andtoensurethatwecarryonourbusinesswithoutinfringingtherightsofothers.
LEO Pharmamakes great efforts to develop andmaintainitscompetencesinthisarea,andtheGroupconsistentlydefendsitsrightsifothersattempttoinfringetheGroup’spatents.
Asoftheendof2011,severallawsuitsfiledbyandagainst LEOPharma relating to patent rights arependingconcerningrightsinrespectofproductsinLEOPharma’spsoriasisportfolio,both intheUSAandinEurope.Asamatterofprinciple,theGroupdoesnotdisclosethecontents,statusandpossibleoutcomeofsuchpendingpatentcases.Moreover,LEOPharmaisapartytoalawsuitintheUSAcon-cerningovertimepaytosalesrepresentatives.ThesuitwasfiledinFebruary2012.LEOPharmadoesnotexpectthecasetohaveanysignificanteffectontheGroup’sfinancialposition.
AlargenumberofLEOPharma’sinsurablerisksarecoveredbyinsurance,whichismanagedbythePar-entCompanyinBallerup.Themostsignificantriskscoveredrelatetoproductliability,buildings,movableproperty,inventories,consequentiallossandtrans-portationofgoods.
Foreign exchange risksBasedontheGroup’sfutureoperatingbudgets,cashflowsinforeigncurrenciesarehedgedonaregularbasis.LEOPharmadoesnothedgenetinvestmentsinforeignaffiliates,andallhedgingofforeignexchangerisksiscentralisedwiththeParentCompany.
Liquidity risksLEOPharmaiswhollyownedbytheLEOFoundation,andconsequentlycurrentcashflowsareaccumulat-edintheParentCompany.AstheGrouphasahighsolvencyratio,wecanseenomaterialliquidityrisks.
Interest rate risksTheloanportfolioconsistsofbothvariable-rateandfixed-rateloans.
Credit risksThemarketfordrugsinEuropehasbeenaffectedbythefinancialcrisis.Greeceisthecountrywhere
LEOPharmahasbeenmostseriouslyhit.In2011,the Group received Greek bonds as payment forreceivablesfromtheGreekauthorities.DuetotheunresolvedfinancialsituationinGreece,LEOPharmamadeaprovisionforbaddebtsin2010.TheFinan-cialStatementsfor2011werepositivelyaffectedbyanetamountofDKK38millionasaresultofpartoftheprovisionfrom2010beingrecognisedasincomein2011.
In2011,theGrouptightenedupitscreditpolicyinordertocounterfuturebaddebts.
Therearenomaterialrisksrelatingtoindividualcus-tomersorbusinesspartners.
The Group’s credit risks relate partly to primaryfinancial assets and partly to derivative financialinstruments with a positive market value. Creditrisks relating to financial assets equal the valuesrecognisedinthebalancesheet.
Expectations for 2012LEOPharmawillcontinuetoimplementitsgrowthstrat-egyin2012,includinginitiativessupportingthepatientfocus reflected inLEOPharma’smissionandvision.
AspartoftheGroup’scorporateMust-WinBattles,LEOPharmawantstocreateaglobalandpatient-centricorganisationinrelationtostructure,pro-cess-esandknowledge-sharing.Inordertoachievethisgoal,theGroupwillstartimplementinganumberofinternalinitiativesin2012andinthecomingyears.
TheGroupwillfurtherexpanditsresearch&devel-opmentprogrammeswithaspecial focusonder-matology.Furthermore,anincreasedandtargetedsalesandmarketingplanisexpectedtohelpmeetthegoalofdouble-digitsalesgrowth.Inthisregard,thelaunchofPicato®intheUSAwillplayaconsider-ablepart.Earningsfor2012areexpectedtobeinlinewith2011.
Elements of uncertaintyItisplannedthatPicato®willbemarketedbytheGroup’sUSaffiliatefromMarch2012.AllpreviousFDAinspectionshaveproceededaccordingtoplan,andtheFDAhasapprovedtheproductformarket-ing.However,aproductlaunchwillalwaysbesub-jecttouncertainty,andiftheproductdoesnotmeetsalesexpectations,thismayhaveanegativeeffectonexpectedresultsfor2012.
SPECIAL BUSINESS AND FINANCIAL RISKS
AnnualReport2011 19
LEOPharma’semployeesarethefoundationsoftheGroup’scontinuedsuccess.Therefore,considerableinvestmentshavebeenmadeintheprofessionalandpersonal development of employees through twomanagementdevelopmentprogrammesandapeo-pledevelopmentsessiontool.
In2011,LEOPharmacompleteditsfirstglobalman-agementdevelopmentprogrammefortheGroup’stop115leaders.Alsolastyear,theGrouplaunchedasimilarmanagementdevelopmentprogrammefor470leadersworldwide.
BothprogrammesaimtogivetheleadersaninsightintotheGroup’sstrategicobjectivesandtools,and
Research & developmentIn2011,theGroupintensifieditsresearch&developmentstrategywithaclearfocusondermatology.Duringthecourseof2011,thepipelinewasstrengthenedconsiderably;seeoverviewabove.Bytheendof2011,LEOPharmahadastrongportfolioofR&Dprojectswithinitsfocusareas:
DermatologyAnumberofclinicalactivitieswereinitiatedinordertoincreasemarketandproductindica-tionsforDaivobet®GelandDaivobet®Ointmentforthetreatmentofbodypsoriasis.
InMarch2011,anapplicationfortheregis-trationofPicato®fortopicaltreatmentofactinickeratosiswasfiledwiththeFDA,whichapprovedthedruginJanuary2012.LEOPharmaalsofiledapplicationsforregistrationwiththeauthoritiesinBrazil,AustraliaandtheEUin2011.
InJanuary2012,LEOPharmain-licensedaprojectinpre-clinicaldevelopment(VBY-891)fortheoraltreatmentofmoderatetoseverepsoria-sisfromtheAmericancompanyVirobay,Inc.
soestablishajointapproachtobeingaleaderatLEOPharma.In addition to management development, theGrouphasfocusedonemployees’professionalandpersonaldevelopment.Atthebeginningof2011,LEOPharmaintroducedpeopledevelopmentses-sionsandimplementedthedialoguetoolPersonalDevelopmentDialogue(PDD).Thistoolgivestheemployeesanopportunitytoexpresstheircareerand development aspirations and, together withtheirlinemanagers,prepareawrittenagreementconcerningthefuturedirectionoftheirprofessionalandpersonaldevelopment.Infuture,PDDwillbeconductedeachyear.
ThrombosisAlthoughLEOPharma’soverallfocusisondermatology,theanti-coagulant(bloodthin-ner)innohep®forthetreatmentofthrombosisisalsopartoftheGroup’sstrategicproductportfolio.
Inordertoexpandtheindicationareaforthrombosis,LEOPharmahasmadeconsider-ableinvestmentsinaclinicalstudy(CATCH)toinvestigatetheeffectsoflong-termtreatmentwithinnohep®forcancerpatientswhohavesuf-feredvenousthrombosis.
Ownership structureLEOPharmaiswhollyownedbytheLEOFoundation,Industriparken55,2750Ballerup,Denmark.
Post-balance sheet eventsNopost-balancesheeteventshaveoccurredinfluencingeitherthefinancialpositionfor2011orexpectationsfor2012.
BASISOF EARNINGS
EARLY CLINICAL CANDIDATEPRE-CLINICAL I II III REGISTRATION LAUNCHEVALUATION
Daivobet® Gel Body psoriasis
LEO 90110Psoriasis
LEO 90100Body psoriasis
LP 0067Psoriasis
VBY-891 Psoriasis
LP 0058Inflammatory indications
LEO 29102Eczema
Picato® GelActinic keratosis
PEP00 5Non-melanoma skin cancer
LEO 27847Nephrology
AnnualReport2011 21
Joint direction and understandingOureffortsasanenterprisearenotonlymeasuredbytheresultsweachieve;howweachievethemisalsoextremelyimportant.LEOPharma’svaluesaretheguidingprincipleswhichensurethatwealwaysdotherightthing.
Tohelpusputourvaluesintoaction,in2011wedevelopedourrulesofethics,theLEO Code of Con-duct,whichallLEOemployeesmustcomplywith.Based on local legislation and the core value ofintegrity,theLEOCodeofConductguidesthecon-ductofemployeesintheirdailyworkandsetsthetonefortheGrouppolicieswhichensurethatourbusinesspracticelivesuptothelegalrequirementsinforceatanytimeandcomplieswithourrulesofethics.Aspartoftheimplementationprocess,ourleadersandemployeesenter intodialogueacrosstheorganisationconcerningourethicalstandards,andemployeescompleteacompulsorye-learningcourseontheLEOCodeofConduct.
Professional management of corporate social responsibilityTheGroup’scorporatesocialresponsibilitybasicallyfocusesonensuringthatallleadersandemployeesliveuptotheLEOvalues.
AllLEOPharmaemployeesmustbeable tocom-municatevaluesandguidelinestocooperationpart-ners,patientorganisations,authorities,healthcarepersonnelandotherstakeholders.
GxPandnon-GxPGroupPoliciesandGuidelinesareunitedinajointqualityassurancesystem.GxPistheabbreviationforthespecificrulesregulatingthepharmaceuticalindustry,i.e.GoodLaboratoryPractice(GLP),GoodClinicalPractice(GCP),GoodManufacturingPractice(GMP)andGoodDistributionPractice(GDP).
Looking to the futureIn2012,LEOPharmaplanstolookintoestablishingawhistleblower function.Furthermore, theGroupintendstoimplementananti-corruptionpolicywhichsetsthetoneforfightingcorruptionasoutlinedintheLEOCodeofConduct.
ENVIRONMENT, HEALTH AND SAFETYItisLEOPharma’sambitiontoensureasafeandhealthyworkingenvironment,protecttheexternalenvironment, minimise energy consumption andpreventpollution.Therefore, it is important thatLEOemployeeshaveacommonunderstandingofwhatthisworkmeans.
Withthisinmind,LEOPharmapreparedanenvi-ronmentalandenergypolicyin2011,aswellasanoccupationalhealthandsafetypolicy.Thesepol-iciesapplytotheentireGroupandwerepublishedintheautumnof2011.Theactualimplementationattheproductionsiteswillbelaunchedinthefirsthalfof2012.
InLEOPharma’sopinion,themostmaterialenvi-ronmentalimpactandenvironmentalrisks,aswellasrisksinrespectofoccupationalhealthandsafe-ty,relatetoproduction.Therefore,theworkontheGroup’senvironmentalandenergypoliciesandoccu-pationalhealthandsafetypolicy,aswellasrelatedactivities and results, focuses on our productionsites.
Certification of our management systemsLEOPharmaisworkingactivelyandprofessionallyonimprovingtheenvironmentandtheworkingenviron-mentinaccordancewithinternationalstandards.Inordertomakesurethatallproductionsiteshaveauniformandstandardisedapproachtothemanage-mentofenvironmentalresponsibilityandresponsi-bilityrelatingtooccupationalhealthandsafety,LEOPharmahasdrawnupaplanforthecertificationofour environmental management system and ouroccupationalhealthandsafetymanagementsystem.ThemanagementsystemsarebasedontheGroup’senvironmentalandenergypoliciesandoccupationalhealthandsafetypolicy,andhelpmanageandcon-tinuouslydevelopourworkwithintheseareas.Oneaspectofthisplanisthatemployeeswhoworkonenvironmentalissuesandissuesrelatingtooccu-pationalhealthandsafetyattheproductionsitesshould, in future, share their experience inordertomakesurethatcertificationunderinternationalstandardsisobtained.
CORPORATE SOCIAL RESPONSIBILITY
Iberia5% LEO DE
4%
LEO US22%
LPI 20%
France-Magreb20%
North Atlantic17%
Nordic-Benelux12%
FORDELING AF TOTALT SALG
LEO CODE OF CONDUCT
GxP Non-GxP
Group PoliciesGroup Guidelines
SOPs
Analytical Methods Test Methods
Work Instructions
Strategiclevel
Operationallevel
8,000
6,000
4,000
2,000
0
7% compared to 2010
7%
NET SALES YEAR-TO-DATE AT ACTUAL RATES
20102011
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
DKK million
22 LEOPharma
Impact of our effortsLEO Pharma continued its comprehensive invest-ments inproperty,plantandequipment in2011,focusingparticularlyonproductionfacilities.Theseinvestmentsarecentraltoreducingtheenvironmen-talimpact,improvingtheworkingenvironmentandincreasingourproductioncapacity.
Inaddition to thepublicationof the LEOPharmaGroup’senvironmentalandenergypolicyandoccu-pationalhealthandsafetypolicy,managementofenvironmental responsibility has been strength-ened.InJuly,theproductionunitinFrancewasISO14001-certified,andinDecemberasuccessfulregis-trationauditwasperformedattheDublinproductionunit.Theregistrationauditors’recommendationinrespectofofficialcertificationofLEOPharma’senvi-ronmentalmanagementsystemisexpectedearlyin2012.
AkeyelementofLEOPharma’senvironmentalman-agementisregularimprovementmeasures,includ-ingmeasures relating toenergy-savingactivities.The Ballerup production unit made a significantcontributiontothisprocesssinceanumberofini-tiativesatthesiteresultedinatotalenergyreduc-tionof3,788MWh.Thiscorrespondsto4.5%ofLEOPharma’stotalenergyconsumptioninDenmarkin2010.Furthermore,thenewenergy-efficientfactoryinEsbjergwascommissionedin2011.In2011,theGroupimplementedthefirstphaseofanenergyprojecttoenabletheDublinproductionunittoproduceenergyitselfandrecoverandreusewasteheatfromtheproductionprocessforwatercooling.Whenthesecondphaseof theproject iscompletedin2012,annualreductionsof8,400MWhand3,600tonsCO
2areexpected.
Targets for the benefit of the environment and peopleAsignificantfocusareafor2012isto initiatetheimplementationofLEOPharma’sglobalpoliciesontheenvironment, energyandoccupational healthandsafety.
Asregardstheenvironmentandoccupationalhealthandsafety,LEOPharmawillconsequentlypursuethefollowingtargetsinordertoachievethedesiredlev-elsin2015:
TARGETS FOR 2015
Environment and energy:ISO14001certificationofallexistingproductionsites
Implementationofenergy-savingprojectsresultingina15%reductioninenergyconsumptioncomparedto2010
Occupational health and safety:OHSAS18001certificationofallexistingproductionsites
LTI(Lost-TimeInjury–i.e.thenumberofaccidentsresultinginmorethanoneday’sabsence)inlinewithbestpracticeinthepharmaceuticalindustrybytheendof2015
ETHICAL RESEARCH AND MANUFACTURING
Thepharmaceuticalindustryisstrictlyregulated,andalldrugsmustcomplywiththerulesofGoodLabor-atory Practice (GLP), Good Clinical Practice (GCP),GoodManufacturingPractice(GMP)andGoodDistri-butionPractice(GDP).
Inadditiontocomplyingwiththeseprinciples,LEOPharmahasananimalwelfarepolicywhichsetsoutguidelines for the animal trials performed by theGroup.Theanimalwelfarepolicydescribeshowtoper-formresearchworkinaccordancewiththeprincipleofthe3Rs,i.e.replace,reduceandrefine.LEOPharma’scooperationpartners,e.g.ContractResearchOrgan-isations(CROs)anduniversities,willalsobeobliged,infuture,toliveuptothemindsetandprinciplespre-scribedbyouranimalwelfarepolicy.
GxP rules show the wayThe quality assurance systems ensure that LEOPharmacomplieswithcurrentrulesandregulationsinconnectionwiththedevelopmentandmanufac-tureofdrugs.
AnimaltrialsareauditedbytheDanishauthorities
CORPORATE SOCIAL RESPONSIBILITY
AllexistingproductionsiteswillbeOHSAS18001-andISO14001-certifiedin2015.Moreover,theproductionunitinDubliniscertifiedundertheenergystandardEN16001.TheproductionunitinCorkexpectstobecertifiedunderthesamestandardin2014.TheremainingproductionsitesintendtoincorporateenergymanagementintheISO14001standard.
PRODUCTION SITE OHSAS 18001(Occupational Health and Safety)
ISO 14001(Environment)
Ballerup and Esbjerg (DK) 2013
Cork (IE) End of 2012
Certified
Certified
2013
Dublin (IE) 2013 Beginning of 2012
Vernouillet (FR) Beginning of 2014
Southport (AU) End of 2014 End of 2014
AnnualReport2011 23
andbyLEOPharma’sinternalAnimalWelfareCoun-cil.TheCouncilhasaninternaladvisoryfunction,butalsodiscussesexternalmatters inrelationtoCROs.Infuture,theLEOPharmaveterinarianwithoverallresponsibilityforanimaltrialswillbeauthor-isedtointerveneinrelationtoCROs.
Inconnectionwithclinicaltrials,theManagementGroupforCROcooperationsupportsanumberofstudygroupsforthepurposeofensuringacommonunderstandingofhowbesttoarrangethecooper-ation.
Focus on cooperationLEOPharmaiscontinuallyworkingonimprovingitsqualityassurancesystems.In2011,LEOQual-ityTrackingwaslaunchedinordertostrengthenquality assurance processes across the Group.Moreover, approximately 1,300 employeesreceivedfurtherGMPtrainingatourproductionsitesin2011.
Inordertoimproveconditionsforbothemployeesandlaboratoryanimalsatmodernlaboratoryanimalfacilities,LEOPharmacontinuedtoplayanactivepartin2011ascooperationpartneroftheCenterforAppliedLaboratoryAnimalResearch(CALAR),whichworksonresearchinthisfieldatthehighestscientificlevel.
In 2011, the Group also focused on developingStandard Operating Procedures (SOPs) specifyingtheguidelinesforcooperationwithCROsinclinicalstudies.
Knowledge and insightThe Group intends to continue the GxP trainingofemployees in2012.Furthermore,LEOPharmaplanstoincreaseanimalwelfareawarenesswithintheorganisationbymakinginformationmoreeasilyaccessibletoallemployees.
AsLEOPharmaexpectsthat,infuture,moreclinicalstudieswilltakeplaceinCROsinChina,aClinicalTrialManagerwasemployed inChina in January2012.ThiswillensuretheimplementationofbestpracticeinthecooperationwithChineseCROsrightfromthestart.
ETHICALMARKETING
Oneof themostsignificantresultsofourethicalmarketingwork in2011wasthedevelopmentofnewguidelinesspecifyinghowLEOPharmamarketsitsdrugsandcommunicatesandcooperateswithhealthcarepersonnel,etc.
ThenewguidelinesformthebasisforensuringthatLEOemployeesarefamilliarwithbothinternalandexternalrulesandregulationsrelatingtothemarketingofdrugs.TogetherwithLEOPharma’sbusinessstrategyandtheLEOCodeofConduct,theguidelinesalsosetthetoneforourethicalmarketing.
Global direction with local controlEmployeesallovertheworldarerequiredtocom-plywiththeethicalmarketingguidelines.Inorderto ensure compliance, the Group’s country and/or region managers are responsible for ensuringthatemployeesaretrainedintheguidelines.Fur-thermore,thecountryand/orregionmanagersareresponsiblefortheimplementationofsystemsandprocedureswhichensurecompliancewithguidelinesandpolicies,aswellaslocalrulesandregulations.
Transparency in patient cooperationInthe2010AnnualReport,LEOPharmamentionedthedevelopmentofaGrouppolicyrelatingtoethicalmarketingasagoalfor2011.PreliminaryworkhasbeenperformedinconnectionwiththeLEOCodeofConduct,andthefinalGrouppolicyisexpectedtobereadyinthefirsthalfof2012.Furthermore,LEOPharmaplanstocontinuetodevelopspecificguidelines.
Throughourcooperationwithpatients’associations,LEOPharmaexchangessignificantknowledgeaboutpatients’ livesand thechallenges facingpatientsduetoillness.Suchknowledgeisdecisiveforthedevelopmentofdrugsandvarioussupport initia-tivesbasedonpatientneeds.LEOPharmawantstransparencyinthedialoguewithpatients’associa-tions.Consequently,asfromJanuary2012,wewillreportonsuchcooperationontheGroup’swebsiteonaregularbasis.
CORPORATE SOCIAL RESPONSIBILITY
AnnualReport2011 25
TheAnnualReportofLEOPharmaA/Sfor2011hasbeen prepared in accordancewith the provisionsoftheDanishFinancialStatementsActapplyingtolargeenterprisesofreportingclassC.
Theaccountingpoliciesappliedremainunchangedfromlastyear.
Recognition and measurementRevenuesarerecognisedintheincomestatementasearned.Furthermore,valueadjustmentsoffinancialassetsandliabilitiesmeasuredatfairvalueoramor-tised costare recognised.Moreover, all expensesarerecognisedintheincomestatement,includingdepreciation,amortisationandimpairmentlosses.
AssetsarerecognisedinthebalancesheetwhenitisprobablethatfutureeconomicbenefitsattributabletotheassetwillflowtotheCompany,andthevalueoftheassetcanbemeasuredreliably.
LiabilitiesarerecognisedinthebalancesheetwhenitisprobablethatfutureeconomicbenefitswillflowoutoftheCompany,andthevalueoftheliabilitycanbemeasuredreliably.
Assetsandliabilitiesareinitiallymeasuredatcost.Subsequently,assetsandliabilitiesaremeasuredasdescribedforeachitembelow.
Certainfinancialassetsandliabilitiesaremeasuredatamortisedcost,whichinvolvestherecognitionofaconstanteffectiveinterestrateoverthematurityperiod.Amortisedcostiscalculatedasoriginalcostless any repayments andwith addition/deductionof the cumulative amortisation of any differencebetweencostandthenominalamount.
Recognition and measurement take into accountpredictable losses and risks occurring before thepresentationoftheAnnualReportwhichconfirmorrefutecircumstancesexistingatthebalancesheetdate.
Danishkronerisusedasthemeasurementcurrency.Allothercurrenciesareregardedasforeigncurrencies.
Consolidated Financial StatementsTheConsolidatedFinancialStatementscomprisetheParentCompanyLEOPharmaA/SandaffiliatesinwhichLEOPharmaA/Sdirectlyorindirectlyholdsmorethan50%ofthevotesorotherwiseexercisescontrol.TheConsolidatedFinancialStatementsarepreparedbycombiningtheFinancialStatementsofthePar-
entCompanyandallaffiliateswithsubsequentelim-inationofintercompanytransactions,intercompanyshareholdingsandbalancesaswell asunrealisedprofitsfromintercompanytransactions.TheFinan-cialStatementsofallcompanieshavebeenpreparedaccordingtothesameaccountingpolicies.
Enterprises acquired during the year and newlyformedenterprisesareincludedintheconsolidationasfromthedateofacquisitionorformation.Enterprisesthataresoldorwoundupduringtheyearareincludedintheconsolidatedincomestatementupuntilthedateofdisposaloruntil thebusinesswaswoundup.Comparativefiguresarenotrestatedfornewlyacquired,soldorwound-upenterprises.
Foreign currency translation Onrecognition,transactionsinforeigncurrenciesaretranslatedattheexchangeratesatthetransactiondates. Exchange differences arising between thetransactiondateratesandtheratesatthepaymentdatesarerecognisedinfinancialincomeandexpens-esintheincomestatement.
Receivables,payablesandothermonetaryitemsinforeigncurrenciesare translatedat theexchangerates at the balance sheet date. Any differencesbetweentheexchangeratesatthebalancesheetdateandtherateatthetimewhenthereceivableorthepayablearises,oratrecognitioninthemostrecentFinancialStatements,arerecognisedinfinan-cialincomeandexpensesintheincomestatement.
On recognitionof foreignaffiliates, incomestate-mentsaretranslatedattheaverageexchangeratesoftheperiod,andbalancesheetitemsaretranslatedattheexchangeratesatthebalancesheetdate.
Exchange adjustments arising on the translationof the opening equity of foreign affiliates at theexchangeratesatthebalancesheetdateandonthetranslationoftheincomestatementfromaverageexchangeratestotheexchangeratesatthebalancesheetdatearerecogniseddirectlyinequity.
Derivative financial instrumentsDerivative financial instruments are recognisedinthebalancesheetatcostandaresubsequentlymeasuredat their fair values.Positiveandnega-tive fairvaluesofderivativefinancial instrumentsarerecognisedinprepaymentsanddeferredincomerespectively.Changes in the fair values of derivative financialinstrumentsthataredesignatedandqualifyasfairvaluehedgesofarecognisedassetorarecognised
ACCOUNTING POLICIES
26 LEOPharma
liabilityarerecognisedintheincomestatementasareanychangesinthefairvalueofthehedgedassetorthehedgedliability.
Changesinthefairvalueoffinancialandderivativefinancialinstrumentsthataredesignatedandqualifyashedgesoffutureassetsorliabilitiesarerecognisedasprepayments/deferred incomeandasfinancialhedgesinequity.Incomeandexpensesrelatingtosuchhedgingtransactionsaretransferredfromequityonrealisationofthehedgeditemandrecognisedasfinancialincomeandexpenses.
RevenueRevenuefromthesaleofgoodsforresaleandfin-ishedgoodsisrecognisedintheincomestatementwhenthesaleisconsideredeffectedbasedonthefollowingcriteria:
•Deliveryhasbeenmadebeforeyear-end
•Thereisabindingsalesagreement
•Thesalespricehasbeendetermined andpaymenthasbeenreceivedormay withreasonablecertaintybeexpected tobereceived
RevenueisrecognisedexclusiveofVATandnetofdiscountsrelatingtosales.
Consumption of raw materials, consumables and goods for resaleExpensesforrawmaterials,consumablesandgoodsforresalecomprisetherawmaterials,consumablesandgoodsforresaleusedtoachievetherevenuefortheyear.
Other external expensesOtherexternalexpensescompriseindirectproduc-tioncostsandexpensesforpremises,salesanddis-tributionaswellasofficeexpenses,etc.
Other external expenses also include research anddevelopmentcoststhatdonotqualifyforcapitalisation.
Staff expensesStaffexpensescomprisewagesandsalariesaswellaspayrollexpensesotherthanproductionwages.
Amortisation, depreciation and impairment lossesAmortisation,depreciationandimpairmentlossescom-
prise amortisation, depreciation and impairment ofintangibleassetsandproperty,plantandequipment.
Other operating incomeLEOPharma’slicenceincomeisrecognisedonthebasisoflicenceholders’salesforthefinancialyearandisstatedasotheroperatingincome.
Otheroperatingincomeincludesnon-recurringincomefromthesaleofrightsandgainsonthesaleoffixedassets,etc.aswellasotheroperating incomeofasecondarynaturetothecoreactivitiesoftheGroup.
Asamainrule,thesaleofrights,etc.isrecognisedasincomeatthetimeofsale.IfthesaleresultsinanobligationfortheLEOGroup,theincomeisaccruedoverthedurationoftheobligation,andinthecaseofsaleswheretheincomeisdependentonfutureevents,theamountisrecognisedasincomewhentheeventoccurs.
Financial income and expensesFinancial incomeandexpensescomprise interest,realised and unrealised exchange adjustments,priceadjustmentofsecuritiesaswellasextrapay-mentsandrepaymentundertheon-accounttaxationscheme.
Tax on profit/loss for the yearTaxfortheyearconsistsofcurrenttaxfortheyearanddeferredtaxfortheyear.Thetaxattributabletotheprofitfortheyearisrecognisedintheincomestatement,whereasthetaxattributabletoequitytransactionsisrecogniseddirectlyinequity.
Anychangesindeferredtaxduetochangestotaxratesarerecognisedintheincomestatement.
Intangible assetsIntangibleassets,includingdevelopmentprojects,aremeasuredatcost.
Costs of development projects comprise salaries,amortisationandotherexpensesdirectlyorindirectlyattributabletotheCompany’sdevelopmentactivities.
Developmentprojectsthatareclearlydefinedandidentifiableand in respectofwhich technical fea-sibility,sufficientresourcesandapotential futuremarket or development opportunity in the enter-prise can be demonstrated, and where it is theintentiontomanufacture,marketorusetheproject,are recognised as intangible assets. This appliesif sufficient certainty exists that the value in useof future earnings can cover cost of production,
ACCOUNTING POLICIES
AnnualReport2011 27
sales, distribution and administrative expensesinvolvedaswellasthedevelopmentcosts.
Developmentprojectsthatdonotmeetthecriteriaforrecognitioninthebalancesheetarerecognisedasexpensesintheincomestatementasincurred.Development projects, patents, trademarks andrights are measured at cost less accumulatedimpairmentlossesandamortisation.Amortisationisprovidedsystematicallyovertheexpectedusefullife,between3and20years.Theamortisationprofileisonastraight-linebasisadjustedfortheriskrelatingtotheunderlyingasset,sothatupto33%oftheamortisationisbroughtforwardfromthesecondhalfoftheexpectedusefullifetothefirsthalf.
Othercostsrelatingtothemaintenanceofpatents,etc.areexpensed.
Projectsareassessedonanongoingbasisconsider-ingdevelopmentprogress,expectedapprovalsandcommercialutilisation.
Property, plant and equipmentProperty,plantandequipmentaremeasuredatcostlessaccumulateddepreciationandlessanyaccumu-latedimpairmentlosses.Costcomprisesexpensesfor materials, sub-suppliers and labour for fixedassetsproduced.Thetotalcostofanassetisbro-kendownintocomponentswhicharedepreciatedseparatelyiftheexpectedusefullivesoftheindivid-ualcomponentsarenotthesame.Anyinterestandotherborrowingexpensesarenotincludedincost.
Depreciation is calculatedona straight-linebasisovertheexpectedusefullives:
Buildings 10-25years
Plantandmachinery 5-10years
Otherfixturesandfittings,toolsandequipment 3-10years
Leaseholdimprovements 0-10years
Profitsandlossesonthesaleofproperty,plantandequipmentarecalculatedasthedifferencebetweenthesalesprice lesssellingexpensesandthecar-ryingamountatthetimeofsale.Profitsorlossesarerecognisedintheincomestatementunderotheroperatingincomeorotheroperatingexpenses.
Thecarryingamountsofintangibleassetsandprop-erty,plantandequipmentarereviewedonanannualbasistodeterminewhetherthereisanyindicationofdecreaseinvalueotherthanthatexpressedbyamortisationanddepreciation.Ifso,animpairment
testiscarriedouttodeterminewhethertherecov-erableamountislowerthanthecarryingamount,and theasset iswrittendown to its lower recov-erableamount.Thisimpairmenttestiscarriedouton an annual basis for development projects inprogress,irrespectiveoftherebeinganyindicationsofdecreaseinvalue.
Therecoverableamountoftheassetiscalculatedasthehigherofnetsellingpriceandvalueinuse.Wherearecoverableamountcannotbedeterminedfortheindividualasset,theassetsareassessedinthe smallest group of assets forwhich a reliablerecoverableamountcanbedeterminedbasedonatotalassessment.
LeasesLeasesunderwhichtheGroupassumessubstan-tiallyalltherisksandrewardsofownership(financeleases)arerecognisedinthebalancesheetatthelowerofthefairvalueoftheleasedassetandthenetpresentvalueoftheleasepaymentscomputedbyapplyingtheinterestrateimplicitintheleaseoranapproximatedvalueasthediscountrate.Assetsacquiredunderfinanceleasesaredepreciatedandwrittendownforimpairmentunderthesamepol-icyasdeterminedfortheotherfixedassetsoftheGroup.
Theremaining leaseobligation iscapitalisedandrecognisedinthebalancesheetunderdebt,andtheinterestelementontheleasepaymentsischargedovertheleasetermtotheincomestatement.
Allother leasesareconsideredoperating leases.Paymentsmadeunderoperatingleasesarerecog-nised in the incomestatementonastraight-linebasisovertheleaseterm.
FIXED ASSET INVESTMENTS
Parent Company’s investments in affiliates IntheAnnualReportoftheParentCompany,invest-mentsinaffiliatesaremeasuredundertheequitymethod.Thismeansthattheaffiliatesaremeasuredinthebalancesheetattheproportionateshareoftheirnetassetvalue,andthattheParentCompany’sshareof theprofit for theyearof theaffiliates isrecognisedintheincomestatementlessunrealisedintercompanyprofits.
SecuritiesTheholdingofbondsthatareheldtomaturityisclassified as fixed asset investments. The bondsareinitiallyrecognisedinthebalancesheetatcost.
ACCOUNTING POLICIES
AnnualReport2011 29
Subsequently,theholdingismeasuredatamortisedcost,whichincludesrevaluation/write-downoftheholdingofbondsatparoverthetermoftheindi-vidualseriesofbonds.
InventoriesRawmaterialsandpackingmaterialsaremeasuredatthelowerofcostundertheFIFOmethodandnetrealisablevalue.
Workinprogressandfinishedgoodsaremeasuredatcost.Thecostoffinishedgoodsandworkinprogresscomprisesthecostofrawmaterials,consumables,directlabourandindirectproductioncosts.Indirectproduction costs comprise indirect materials andlabouraswellasmaintenanceanddepreciationofthemachinery,factorybuildingsandequipmentusedinthemanufacturingprocessandcostsoffactoryadministrationandmanagement.
Thenetrealisablevalueofinventoriesiscalculatedas salespricewithdeductionof costsof comple-tionandexpensesincurredtoeffectthesaleandisdeterminedallowingformarketability,obsolescenceanddevelopmentinexpectedsalesprice.
Obsoletegoods,includingslow-movinggoods,areexpensed.
ReceivablesReceivablesaremeasuredatamortisedcost,whichusuallycorrespondstonominalvaluelesspotentialbaddebts.Basedonan individual assessmentofeachtradereceivable,provisionsforbaddebtshavebeenmadewherethisisconsiderednecessary.
Exchange adjustments of intercompany balanceswithaffiliateswhichareconsideredpartofthetotalnetinvestmentintheaffiliatearerecogniseddirectlyinequity.
Prepayments and deferred income Prepaymentsincludeprepaidexpensesincurredrelatingtorent,insurancepremiums,subscriptionsandinterest.
Deferred income includes payments received inrespectofincomeinsubsequentfinancialyears.
ProvisionsProvisionsarerecognisedwhen– inconsequenceofaneventthatoccurredbeforeoronthebalancesheetdate–theGrouphasalegalorconstructiveobligation,anditisprobablethateconomicbenefitsmustbegivenuptosettletheobligation.Provisionsarenotdiscounted.
PensionsPaymentsintodefinedcontributionplansarerecog-nisedintheincomestatementintheperiodtowhichtheyrelate,andanyamountspayablearerecognisedinotherpayablesinthebalancesheet.
Inrespectofdefinedbenefitplansanannualactu-arialcalculationismadeofthevalueinuseoffuturepaymentsunder thescheme.Thevalue inuse iscalculatedonthebasisofassumptionsrelatingtofuturedevelopments inpay levels, interest rates,inflationandmortality.ThevalueinuseiscalculatedonlyforthebenefitstowhichtheemployeeshaveearnedarightthroughtheiremploymentwiththeGroup.Theactuariallydeterminedvalueinuselessthemarketvalueofanyplanassetsisrecognisedinpensionobligationsinthebalancesheet.PlanassetsarerecognisedtotheextenttheGroupisabletoobtainfutureeconomicbenefitsintheformofreim-bursementfromthepensionschemeorreductionoffuturepayments.
Pensioncostsfortheyeararerecognisedintheincome statement based on actuarial estimatesandfinancialexpectationsatthebeginningoftheyear.
Anydifferencesbetweenexpecteddevelopmentsinplanassetsandpensionobligationsandreal-isedvaluescalculatedatthebeginningoftheyearareconsideredactuarialgainsorlosses.Actuar-ialgainsandlossesarerecognisedinincomeorexpensesbasedonacorridorof0%.Calculatedgainsandlossesarerecognisedovertheexpect-edaverageremainingemploymentperiodoftheemployees comprised by the pension scheme.Pensioncostsrelatingtopreviousyearsaredis-tributedovertheaverageperioduntilthebenefitshavevested.
TaxThecorporationtaxrecognisedintheincomestate-mentconsistsofcurrenttaxfortheyear,changesinprovisionfordeferredtaxandadjustmentstoprevi-ousyears.Taxattributabletoequitytransactionsisrecogniseddirectlyinequity.
Deferredtaxisprovidedundertheliabilitymethodandcomprisesalltemporarydifferencesbetweenthecarryingamountandtaxbaseofassetsandliabili-ties.Deferredtaxisalsoincludedtocoverrecaptureoftax-deductiblelossesinforeignaffiliateswhichareexpectedtobecomerelevantasaconsequenceoffutureearningsofpreviouslyjointlytaxedforeignaffiliates.
The tax bases of tax losses carried forward andtax incentivescarried forwardare included in the
ACCOUNTING POLICIES
AnnualReport2011 31
statementofdeferredtaxtotheextentthesevaluesarelikelytobeutilisedinfuturetaxableincome.
Deferredtaxrelatingtopotentialgainsandlosseson investments inaffiliates isnot includedunlessthesharesareexpectedtobesoldwithinashortperiodoftime,inwhichcasetheshareholdingsaretransferredtocurrentassets.
Deferredtaxiscalculatedattheexpectedtaxratefortheenterpriseconcerned.Taxpayableincludescurrenttaxcalculatedonthebasisoftheexpectedtaxableincomefortheyearaswellasanyadjust-mentfortaxespayableforpreviousyears.
TheParentCompanyisjointlytaxedwithitsDanishafiliates.ThejointlytaxedDanishenterpriseshaveadoptedtheon-accounttaxationscheme.CurrenttaxfortheyearofthejointlytaxedDanishenterprisesandtaxonrecapturedincomeareincludedinthePar-entCompany’staxcharge.ThejointlytaxedDanishenterprisessettlethetaxwiththeParentCompany.
Extrapaymentsandrepaymentsrelatingtothepay-mentofcorporationtaxareclassifiedasfinancialincomeandexpensesandarenot includedintaxprovisionsorintheadjustedincometax.
Segment reportingRevenueisbrokendowngeographically.
Definition of ratios
Averagenumberofemployees
Profitmargin
Returnonassets
Returnonequity
Solvencyratio
Cash flow statementThecashflowstatementispreparedaccordingtotheindirectmethodbasedonprofitbeforetax.Thestatementshowscashflowsfromoperating,invest-ingandfinancingactivitiesaswellascashandcashequivalentsattheendoftheyear.
CashflowsfromoperatingactivitiesarecalculatedastheGroup’sprofit/lossfortheyearbeforeextraordi-naryitemsandtaxadjustedfornon-cashoperatingitemssuchasdepreciation,amortisationandimpair-mentlossesaswellaschangesinworkingcapital.Workingcapitalcomprisesinventories,tradereceiv-ablesandtradepayables,etc.
Cashflowsfrominvestingactivitiescomprisepay-mentsfromacquisitionsanddisposalsofintangibleassets, property, plant and equipment aswell asfixedassetinvestments.
Cashflowsfromfinancingactivitiescomprisepay-mentsfromtheraisingandrepaymentofshort-termandlong-termdebt.
Cashandcashequivalentsonlycomprisecashatbankandinhand.
ACCOUNTING POLICIES
Averagenumberoffull-timeequivalentemployees
Operatingprofit
Revenue
Operatingprofit
Averageassets
Profitbeforetax
Averageequity
Equity
Assets
x100
x100
x100
x100
AnnualReport2011 35
INCOME STATEMENT
GROUP PARENT COMPANY
2011 2010 2011 2010 Note DKKmillion DKKmillion DKKmillion DKKmillion
Revenue (1) 7,741 7,245 5,681 5,579Changeininventoriesoffinished goodsproducedandworkinprogress 412 95 106 20
8,153 7,340 5,787 5,599 Other operating income 97 59 441 486
8,250 7,399 6,228 6,085 Consumptionofrawmaterials,consumablesandgoodsforresale 862 408 2,805 2,425Otherexternalexpenses (2) 3,595 3,314 2,063 1,869Staffexpenses (3) 2,670 2,091 1,027 818Depreciation,amortisationandimpairmentlosses (4) 955 1,380 749 928Otheroperatingexpenses 10 29 0 25 OPERATING PROFIT/LOSS 158 177 -416 20 Incomefrominvestmentsinaffiliatesaftertax (10) 0 0 366 42Financialincome (5) 917 1,055 856 1,045Financialexpenses (6) 79 168 106 181 PROFIT/LOSS BEFORE TAX 996 1,064 700 926 Taxonprofit/lossfortheyear (7) 372 364 76 226 NET PROFIT/LOSS FOR THE YEAR 624 700 624 700 proposedtobedistributedasfollows: Proposeddividendfortheyear 130 0Retainedearnings 494 700 624 700
36 LEOPharma
BALANCE SHEET AT 31 DECEMBER GROUP PARENT COMPANY
Assets 2011 2010 2011 2010 Note DKKmillion DKKmillion DKKmillion DKKmillion
FIXED ASSETS Intangible assets Industrialpropertyrights 1,816 2,442 1,816 2,442Trademarks 0 0 0 0Developmentprojects 426 527 0 0Total (8) 2,242 2,969 1,816 2,442 Property, plant and equipment Landandbuildings 1,006 764 532 419Leaseholdimprovements 43 19 0 0Plantandmachinery 638 512 307 254Otherfixturesandfittings,toolsandequipment 97 107 78 94Fixedassetsunderconstruction 274 479 170 276Total (9) 2,058 1,881 1,087 1,043 Fixed asset investments Investmentsinaffiliates (10) 0 0 2,119 2,029Othersecurities (11) 19,728 18,361 19,728 18,361Deferredtaxassets (14) 572 275 0 0Total 20,300 18,636 21,847 20,390 TOTAL FIXED ASSETS 24,600 23,486 24,750 23,875 CURRENT ASSETS Inventories Rawmaterialsandconsumables 221 297 111 108Workinprogress 679 377 326 233Finishedgoodsandgoodsforresale 353 243 177 164Total 1,253 917 614 505 Receivables Tradereceivables 1,803 1,753 608 513Receivablesfromaffiliates 0 0 2,393 1,815Otherreceivables 871 805 754 742Prepayments 83 113 14 30Total 2,757 2,671 3,769 3,100 Cash at bank and in hand 354 217 8 0 TOTAL CURRENT ASSETS 4,364 3,805 4,391 3,605 TOTAL ASSETS 28,964 27,291 29,141 27,480
AnnualReport2011 37
BALANCE SHEET AT 31 DECEMBER GROUP PARENT COMPANY
Equity and liabilities 2011 2010 2011 2010 Note DKKmillion DKKmillion DKKmillion DKKmillion
EQUITY Sharecapital (12) 250 250 250 250Retainedearnings 21,046 20,583 21,046 20,583Proposeddividend 130 0 130 0 TOTAL EQUITY (13) 21,426 20,833 21,426 20,833 PROVISIONS Deferredtax (14) 506 407 502 427Pensionobligations (15) 31 68 0 0Otherprovisions (15) 449 293 50 66 TOTAL PROVISIONS 986 768 552 493 LIABILITIES Long-term liabilities Creditinstitutions 0 57 0 57Total 0 57 0 57 Short-term liabilities Creditinstitutions 4,658 4,486 4,612 4,472Tradepayables 384 376 215 209Payablestoaffiliates 2 6 1,769 1,148Corporationtax 440 21 30 0Deferredincome 50 50 50 50Otherpayables 1,018 694 487 218Total 6,552 5,633 7,163 6,097 TOTAL LIABILITIES 6,552 5,690 7,163 6,154 TOTAL EQUITY AND LIABILITIES 28,964 27,291 29,141 27,480 Contingencies (16) Financialinstruments (17) Relatedparties (18)
AnnualReport2011 39
CASH FLOW STATEMENT FOR THE LEO GROUP
GROUP
2011 2010 DKKmillion DKKmillion
CASH FLOWS FROM OPERATING ACTIVITIES
Profit before tax 996 1,064
Adjustments: Depreciation,amortisationandimpairmentlosses 955 1,380Unrealisedexchangeadjustments -9 16Exchangeadjustment,securities -13 -78Corporationtaxpaid -173 -602Pensionobligations -39 11Otherprovisions 204 41Otheradjustments -20 26 Changeinworkingcapital: Changeininventoriesandreceivables -326 -345Changeintradepayablesandotherpayables 215 414
1,790 1,927 CASH FLOWS FROM INVESTING ACTIVITIES Investmentsinproperty,plantandequipment,net -410 -541Fixedassetinvestments,net -1,355 2,229
-1,765 1,688 CASH FLOWS FROM FINANCING ACTIVITIES Netproceeds,long-termdebt 0 -643Changeinbankdebt 112 -7,906
112 -8,549 TOTAL CHANGE IN CASH AND CASH EQUIVALENTS 137 -4,934 Cash and cash equivalents at 1 January 217 5,151 Cash and cash equivalents at 31 December 354 217
ThefiguresinthecashflowstatementcannotbedirectlyderivedfromthefiguresintheConsolidatedFinancialStatements.
42 LEOPharma
NOTES TO THE FINANCIAL STATEMENTS
GROUP PARENT COMPANY
2011 2010 2011 2010 DKKmillion DKKmillion DKKmillion DKKmillion
Note 1 – Revenue
Segmentation – geographical
SalesinDenmark 249 212 249 212
SalesoutsideDenmark 7,492 7,033 5,432 5,367
Total net sales 7,741 7,245 5,681 5,579
Note 2 – Other external expenses
Fee to auditors appointed at the general meeting:
StatutoryauditoftheFinancialStatements 6 5 2 2
Otherassuranceengagements 1 0 0 0
Taxassistance 7 3 3 1
Otherservices 3 6 2 3
17 14 7 6
Note 3 – Staff expenses
Wages,salariesandremuneration 2,287 1,745 956 754
Pensions 205 195 85 75
Othersocialsecurityexpenses 198 170 6 8
Ofwhichcapitalised -20 -19 -20 -19
2,670 2,091 1,027 818
Average number of employees for the year 4,391 3,796 1,533 1,418
RemunerationtotheBoardofDirectorsamountsto
DKK4million(2010:DKK1million).
RemunerationtotheBoardofExecutivesamountsto
DKK20million(2010:DKK20million).
Note 4 – Depreciation, amortisation and
impairment losses
Industrialpropertyrights 626 807 626 807
Developmentprojects 99 361 0 0
Landandbuildings 87 80 45 41
Leaseholdimprovements 8 3 0 0
Plantandmachinery 103 97 51 53
Otherfixturesandfittings,toolsandequipment 32 32 27 27
955 1,380 749 928
AnnualReport2011 43
NOTES TO THE FINANCIAL STATEMENTS
GROUP PARENT COMPANY
2011 2010 2011 2010 DKKmillion DKKmillion DKKmillion DKKmillion
Note 5 – Financial income
Interestincomeonbonds 818 899 818 899
Interestincomefromaffiliates 0 0 8 5
Exchangegains 68 64 0 50
Otherfinancialincome 31 92 30 91
917 1,055 856 1,045
Note 6 – Financial expenses
Interestexpensestoaffiliates 0 0 19 18
Exchangelosses 0 0 13 0
Otherfinancialexpenses 79 168 74 163
79 168 106 181
Note 7 – Tax on profit/loss for the year
Currenttaxfortheyear 566 200 -2 -4
Changeindeferredtax -194 164 82 230
Adjustmentrelatingtopreviousyears 0 0 -4 0
372 364 76 226
Tax on changes in equity 4 -24 4 -24
TaxinaffiliatestotalsDKK296million
(2010:DKK138million).
44 LEOPharma
NOTES TO THE FINANCIAL STATEMENTSGroup
Total
Industrial Development intangible
DKKmillion propertyrights Trademarks projects assets
Note 8 – Intangible assets
Costat1January2011 4,884 9 1,678 6,571
Exchangeadjustment 0 0 39 39
Total cost at 31 December 2011 4,884 9 1,717 6,610
Amortisationat1January2011 2,442 9 1,151 3,602
Exchangeadjustment 0 0 41 41
Amortisationfortheyear 626 0 99 725
Total amortisation at 31 December 2011 3,068 9 1,291 4,368
CARRYING AMOUNT AT 31 DECEMBER 2011 1,816 0 426 2,242
Costat1January2010 4,884 9 1,551 6,444
Exchangeadjustment 0 0 127 127
Total cost at 31 December 2010 4,884 9 1,678 6,571
Amortisationat1January2010 1,635 9 727 2,371
Exchangeadjustment 0 0 63 63
Amortisationfortheyear 807 0 0 807
Impairmentlossesfortheyear 0 0 361 361
Total amortisation at 31 December 2010 2,442 9 1,151 3,602
CARRYING AMOUNT AT 31 DECEMBER 2010 2,442 0 527 2,969
AnnualReport2011 45
NOTES TO THE FINANCIAL STATEMENTSParent Company
Total
Industrial intangible
DKKmillion propertyrights Trademarks assets
Note 8 – Intangible assets
Costat1January2011 4,884 6 4,890
Total cost at 31 December 2011 4,884 6 4,890
Amortisationat1January2011 2,442 6 2,448
Amortisationfortheyear 626 0 626
Total amortisation at 31 December 2011 3,068 6 3,074
CARRYING AMOUNT AT 31 DECEMBER 2011 1,816 0 1,816
Costat1January2010 4,884 6 4,890
Total cost at 31 December 2010 4,884 6 4,890
Amortisationat1January2010 1,635 6 1,641
Amortisationfortheyear 807 0 807
Total amortisation at 31 December 2010 2,442 6 2,448
CARRYING AMOUNT AT 31 DECEMBER 2010 2,442 0 2,442
46 LEOPharma
NOTES TO THE FINANCIAL STATEMENTSGroup
Otherfixtures Total Leasehold andfittings, Fixedassets property,
Landand improve- Plantand toolsand under plant and
DKKmillion buildings ments machinery equipment construction equipment
Note 9 – Property, plant and equipment
Costat1January2011 1,853 26 1,829 612 479 4,799
Exchangeadjustment 0 0 -2 0 0 -2
Additionsfortheyear 332 36 229 22 247 866
Disposalsfortheyear -8 -6 0 -13 -452 -479
Total cost at 31 December 2011 2,177 56 2,056 621 274 5,184
Depreciationandimpairmentlossesat
1January2011 1,089 7 1,317 505 2,918
Exchangeadjustment 2 1 -2 0 1
Depreciationandimpairmentlosses,disposals
fortheyear -7 -3 0 -13 -23
Depreciationfortheyear 87 8 103 32 230
Total depreciation and impairment
losses at 31 December 2011 1,171 13 1,418 524 3,126
CARRYING AMOUNT AT 31 DECEMBER 2011 1,006 43 638 97 274 2,058
Costat1January2010 1,731 12 1,728 603 214 4,288
Exchangeadjustment 7 2 3 3 0 15
Adjustment,beginningofyear 0 0 0 0 1 1
Additionsfortheyear 125 14 121 18 490 768
Disposalsfortheyear -10 -2 -23 -12 -226 -273
Total cost at 31 December 2010 1,853 26 1,829 612 479 4,799
Depreciationandimpairmentlossesat
1January2010 1,016 5 1,240 480 2,741
Exchangeadjustment 3 1 2 2 8
Depreciationandimpairmentlosses,
disposalsfortheyear -10 -2 -22 -9 -43
Depreciationfortheyear 79 3 83 32 197
Impairmentlossesfortheyear 1 0 14 0 15
Total depreciation and impairment
losses at 31 December 2010 1,089 7 1,317 505 2,918
CARRYING AMOUNT AT 31 DECEMBER 2010 764 19 512 107 479 1,881
AnnualReport2011 47
NOTES TO THE FINANCIAL STATEMENTSParent company
Otherfixtures Total andfittings, Fixedassets property,
Landand Plantand toolsand under plant and
DKKmillion buildings machinery equipment construction equipment
Note 9 – Property, plant and equipment
Costat1January2011 937 965 488 276 2,666
Additionsfortheyear 158 104 11 151 424
Disposalsfortheyear -1 0 0 -257 -258
Total cost at 31 December 2011 1,094 1,069 499 170 2,832
Depreciationandimpairmentlosses
at1January2011 518 711 394 1,623
Depreciationandimpairmentlosses,
disposalsfortheyear -1 0 0 -1
Depreciationfortheyear 45 51 27 123
Total depreciation and impairment
losses at 31 December 2011 562 762 421 1,745
CARRYING AMOUNT AT 31 DECEMBER 2011 532 307 78 170 1,087
Costat1January2010 865 917 482 122 2,386
Additionsfortheyear 73 67 10 293 443
Disposalsfortheyear -1 -19 -4 -139 -163
Total cost at 31 December 2010 937 965 488 276 2,666
Depreciationandimpairmentlosses
at1January2010 478 677 370 1,525
Depreciationandimpairmentlosses,
disposalsfortheyear -1 -19 -3 -23
Depreciationfortheyear 40 39 27 106
Impairmentlossesfortheyear 1 14 0 15
Total depreciation and impairment
losses at 31 December 2010 518 711 394 1,623
CARRYING AMOUNT AT 31 DECEMBER 2010 419 254 94 276 1,043
48 LEOPharma
NOTES TO THE FINANCIAL STATEMENTS
GROUP PARENT COMPANY
2011 2010 2011 2010 DKKmillion DKKmillion DKKmillion DKKmillion
Note 10 – Investments in affiliates
Costat1January 2,035 2,005
Additionsfortheyear 213 30
Total cost at 31 December 2,248 2,035
Valueadjustmentat1January -6 765
Shareofprofit/lossfortheyear 366 42
Dividends -448 -920
Exchangeadjustments 166 111
Exchangeadjustmentofequity-equivalentloans -207 0
Adjustments,beginningofyear 0 -4
Total value adjustment at 31 December -129 -6
CARRYING AMOUNT AT 31 DECEMBER 2,119 2,029
Note 11 – Other securities
Costat1January 18,321 20,596 18,321 20,596
Additionsfortheyear 3,346 2,249 3,346 2,249
Disposalsfortheyear -1,981 -4,524 -1,981 -4,524
Total cost at 31 December 19,686 18,321 19,686 18,321
Valueadjustmentat1January 40 44 40 44
Valueadjustmentfortheyear 6 6 6 6
Valueadjustmentondisposalsfortheyear -4 -10 -4 -10
Total value adjustment at 31 December 42 40 42 40
Carrying amount at 31 December 19,728 18,361 19,728 18,361
Market value on the balance sheet date 20,421 18,304 20,421 18,304
AnnualReport2011 49
NOTES TO THE FINANCIAL STATEMENTS
Note 12 – Share capital
Thesharecapital,whichis100%ownedbytheLEO
Foundation,Ballerup,Denmark,isdistributedasfollows:
Preference shares:
640sharesofDKK100k 64,000
309sharesofDKK50k 15,450
34sharesofDKK10k 340
210sharesofDKK1k 210
Total preference shares 80,000
Ordinaryshares
660sharesofDKK100k 66,000
78sharesofDKK50k 3,900
7sharesofDKK10k 70
30sharesofDKK1k 30
100sharesofDKK1,000k 100,000
Total ordinary shares 170,000
Total share capital (DKK thousand) 250,000
In2009,therewasashareincreaseof100sharesofanominalamountofDKK1millionpershare.
TheConsolidatedFinancialStatementsoftheLEOFoundationmaybeobtainedatthefollowingaddress:
Industriparken55,2750Ballerup,Denmark.
50 LEOPharma
NOTES TO THE FINANCIAL STATEMENTS
Note 13 – Consolidated equity 2011
Retained Proposed DKKmillion Sharecapital earnings dividend Total
Equityat1January 250 20,583 0 20,833
Exchangeadjustments 0 166 0 166
Taxonchangesinequity 0 -4 0 -4
Exchangeadj.ofequity-equivalentloans 0 -165 0 -165
Adjustmentoffinancialinstruments 0 -28 0 -28
Proposeddividendforthefinancialyear 0 -130 130 0
Netprofit/lossfortheyear 0 624 0 624
Equity at 31 December 250 21,046 130 21,426
Note 13 – Parent Company equity 2011
Equityat1January 250 20,583 0 20,833
Exchangeadjustments 0 166 0 166
Taxonchangesinequity 0 -4 0 -4
Exchangeadj.ofequity-equivalentloans 0 -165 0 -165
Profit/lossfromaffiliateaftertax 0 366 0 366
Profit/lossinParentCompany 0 258 0 258
Adjustmentoffinancialinstruments 0 -28 0 -28
Proposeddividendforthefinancialyear 0 -130 130 0
Equity at 31 December 250 21,046 130 21,426
Note 13 – Consolidated equity 2010
Retained Sharecapital earnings Total
Equityat1January 250 19,847 20,097
Exchangeadjustments 0 111 111
Changesrelatingtoaffiliates 0 -4 -4
Adjustmentoffinancialinstruments 0 -71 -71
Netprofit/lossfortheyear 0 700 700
Equity at 31 December 250 20,583 20,833
Note 13 – Parent Company equity 2010
Net Retained Sharecapital revaluations earnings Total
Equityat1January 250 765 19,082 20,097
Exchangeadjustments 0 111 0 111
Changesrelatingtoaffiliates 0 -4 0 -4
Profit/lossfromaffiliatesaftertax 0 42 0 42
Dividendreceived 0 -920 920 0
Profit/lossinParentCompany 0 0 658 658
Adjustmentoffinancialinstruments 0 0 -71 -71
Transfer 0 6 -6 0
Equity at 31 December 250 0 20,583 20,833
AnnualReport2011 51
NOTES TO THE FINANCIAL STATEMENTS
GROUP PARENT COMPANY
2011 2010 2011 2010 DKKmillion DKKmillion DKKmillion DKKmillion
Note 14 – Deferred tax (net)
Deferredtaxat1January -132 13 -427 -220
Adjustmentsrelatingtopreviousyears 4 -4 4 0
Deferredtaxonprofit/lossfortheyear 194 -141 -79 -207
Deferred tax at 31 December 66 -132 -502 -427
Thedeferredtaxrelatestocurrentassets,licences,fixed
assetsandlossesrelatingtopreviouslyjointlytaxed
foreignaffiliates,intercompanyprofits,indirectproduction
costs,etc.
IntheGroup’sbalancesheet,DKK572million(2010:
DKK275million)isrecognisedinfixedassetinvestments,
andDKK506million(2010:DKK407million)isrecognised
inprovisions.
Note 15 – Pension obligations and other provisions
Pension obligations
Provisionforpensionobligationsat1January 68 56 0 0
Exchangeadjustment,beginningofyear 1 1 0 0
Adjustmentfortheyear -38 11 0 0
Provision for pension obligations at 31 December 31 68 0 0
TheGroup’scompaniesinIreland,theUK,theNetherlands
andNorwayoperatedefinedbenefitplans.
Deficitsrelatingtopensionschemesat31December2011
totalDKK392million(2010:DKK284million).
Other provisions
TheGroup’sotherprovisionsat31December2011
totalDKK449million(2010:DKK293million).Inthe
ParentCompany,otherprovisionstotalDKK50million
(2010:DKK66million).Otherprovisionscomprise
expectedexpensesrelatingtotheobligationtoaccept
returnedgoods,discounts,restructuringandseverance
pay,etc.
AnnualReport2011 53
NOTES TO THE FINANCIAL STATEMENTS
Note 16 – Contingencies
TheParentCompany’ssecurityprovidedandguaranteecommitmentstotalDKK153millionat31December2011
(2010:DKK136million).
TheamountrelatingtotheGrouptotalsDKK165millionat31December2011(2010:DKK148million).
GuaranteesissuedconcerningtheGroup’sIrishcompaniescompriseallliabilitiesofthecompanies.At31
December2011,thecompanieshadtotalliabilitiesofDKK131million(2010:DKK116million).
TheParentCompanyhasleaseobligationsofDKK37million(2010:DKK37million).OfthisDKK24millionrelates
toaffiliates(2010:DKK23million).LeaseobligationsrelatingtotheGrouptotalDKK335million(2010:DKK304
million).
AssecurityforabankloanandoverdraftfacilitiesatacarryingamounttotallingDKK4,658million(2010:DKK
4,543million),aswellastheestablishmentofguaranteecommitmentsatavalueofDKK16million(2010:DKK
14million),LEOPharmaA/ShaspledgedbondsatacarryingamountofDKK4,692million(2010:4,883million).
TheamountrelatingtotheGroupalsototalsDKK4,692million(2010:DKK4,883million).
TheParentCompanyhasissuedaletterofsupportinrespectoftheaffiliatesLEOPharmaceuticalProductsHellas
Ltd.,Greece,andAktieselskabetaf30.april2003,Denmark.
Attheendof2011,thereareseveralpendingpatentlawsuitsfiledbyandagainstLEOPharmaconcerningrights
relatingtoproductsinLEOPharma’spsoriasisportfolioinboththeUSAandEurope.LEOPharmaisalsopartytoa
lawsuitintheUSAconcerningovertimepaytosalesrepresentatives.ThelawsuitwasfiledinFebruary2012.LEO
PharmadoesnotexpectthependingcasestohaveanysignificanteffectonthefinancialpositionoftheGroup.
Note 17 – Financial instruments
TheGroupandtheParentCompanyusebothoptionandforwardcontractsaspartofmanagingforeignexchangerisks.
At31December2011,thereareoutstandingforwardcontractsin:AUD,HKD,JPY,KRW,PLN,SAR,SEK,THBand
ZAR.Thecontractamountat31December2011totalsDKK325million(2010:DKK406million).
At31December2011,thereareoutstandingoptioncontractsin:AUD,CAD,CHF,CNY,GBP,JPY,NOK,SEKandUSD.
Thecontractamountat31December2011totalsDKK1,815million(2010:DKK487million).
At31December2011,theGroupandtheParentCompanyalsohaveoptioncontractsin:AUD,CAD,CHF,CNY,EUR,GBP,
JPY,NOK,SEKandUSD.At31December2011,thecontractamounttotalsDKK4,455million(2010:DKK670million).
Note 18 – Related parties
LEOPharmaA/S’srelatedpartieswithsignificantinfluencecomprisetheCompany’sBoardofDirectors,Boardof
Executives,theLEOFoundationandaffiliatesofLEOPharmaA/S.
LEOPharmahashadrelatedpartytransactions,allofwhichhavebeensettledonanarm’slengthbasis.
54 LEOPharma
INVESTMENTS IN AFFILIATES
Nominal Reg. office Ownership Currency capital ‘000
LøvenskemiskeFabriksHandelsaktieselskabet Denmark 100% DKK 30,000
QSIPharmaA/S Denmark 100% DKK 1,250
Aktieselskabetaf30.april2003 Denmark 100% DKK 1,700
SARLLEOPharma Algeria 100% DZD 2,000
PeplinPtyLimited Australia 100% AUD 0
PeplinResearchPtyLtd. Australia 100% AUD 0
PeplinBiolipidsPtyLtd Australia 100% AUD 0
PeplinOperationsPtyLtd Australia 100% AUD 0
PeplinUnitTrust Australia 100% AUD 0
LEOPharmaPtyLtd Australia 100% AUD 0
LEOPharmaNV Belgium 100% EUR 273
LEOPharmaLTDA. Brazil 100% BRL 4,500
LEOPharmaInc. Canada 100% CAD 8,400
LEOLaboratoriesLtd. UK 100% GBP 12,000
LEOPharmaOY Finland 100% EUR 151
LaboratoiresLEOS.A. France 100% EUR 9,000
LEOPharmaceuticalProductsHellasLtd. Greece 100% EUR 28,600
LEOPharmaBV Netherlands 100% EUR 227
LEOLaboratoriesLtd. Ireland 100% EUR 22,100
LEOPharmaceuticalProductsLtd. Ireland 100% EUR 13
WexportLtd. Ireland 100% EUR 2,600
LEOPharmaHoldingLtd. Ireland 100% EUR 100
PeplinIrelandLimited Ireland 100% EUR 22,239
LEOFarmaceuticiS.r.l. Italy 100% EUR 10
LEOPharmaS.p.A Italy 100% EUR 620
LEOPharmaK.K. Japan 100% JPY 10,000
LEOPharmaConsultancycompanylimited China 100% CNY 10,243
LEOPharmaLLC Morocco 100% MAD 100
LEOPharmaAS Norway 100% NOK 3,000
LEOPharmaSp.z.o.o. Poland 100% PLN 50
LEOFarmacêuticosLda. Portugal 100% EUR 626
LEOPharmaceuticalProductsSarathLtd. Switzerland 100% CHF 50
LEOPharmaAsiaPTELtd. Singapore 100% SGD 100
LaboratoriosLEOPharmaS.A. Spain 100% EUR 1,214
LEOPharmaAB Sweden 100% SEK 1,000
LövensLäkemedelAB Sweden 100% SEK 100
LEOPharmas.r.o. CzechRepublic 100% CZK 350
LEOPharmaSARL Tunisia 100% TND 10
LEOPharmaİlaçTicaretAnonimŞirketi Turkey 99.96% TRY 50
LEOPharmaGmbH Germany 100% EUR 750
LEOPharmaceuticalProductsInc. USA 100% USD 1
LEOLaboratoriesLtd. USA 100% USD 1
LEOPharmaAmericasInc. USA 100% USD 50
LEOPharmaInc. USA 100% USD 2,500
PeplinInc. USA 100% USD 15
NeosilInc. USA 100% USD 5
PeplinOperationsUSAInc. USA 100% USD 1
LEOPharmaGmbH Austria 100% EUR 76
Design&Production:AgergaardProofreading:BorellaprojectsPhotos:PeterBrinchPhotographyPrinting:RosenbergBogtrykApS
ThankyoutotheLEOPharmaemployeeswhoallowedtheirphotostobetakenfortheAnnualReport.
TheAssyrianlionbecametheregisteredtrademarkofLøvensKemiskeFabrikin1911.Ithadbeenintroducedin1905asthelogoofKøbenhavnsLøveapotekbyartistAnnaRink,whohadtakenherinspirationfromanAssyrianbas-reliefattheLouvreinParis.
TheLEOlionhasdefinedthecompany’svisualidentityforacentury.OverthelasthundredyearsthelogohasbecomesynonymouswiththeLEOPharmabrandworldwide.