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“Corporate Overview & Strategic Vision” Jefferies Healthcare Conference June 7, 2017
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Page 1: JefferiesHealthcare Conference “Corporate Overview & Strategic … · 2017-06-15 · 2 Disclaimer This presentation includes certain statements that constitute “forward -looking

“CorporateOverview&StrategicVision”Jefferies HealthcareConference

June7, 2017

Page 2: JefferiesHealthcare Conference “Corporate Overview & Strategic … · 2017-06-15 · 2 Disclaimer This presentation includes certain statements that constitute “forward -looking

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DisclaimerThispresentationincludescertainstatementsthatconstitute“forward-lookingstatements”withinthemeaningofapplicablesecuritieslaws.Forward-lookingstatementsinclude,butarenotlimitedto,statementsregardinggrowingrevenuebaseandgeographicfootprintacrossNorthAmericaandEurope;buildingonanchorpositions incardiovasculardiseaseandpainmanagementandopportunisticallyexpandingintootherspecialtytherapeuticareas;accessinghighpotentialgrowthopportunitiesthroughaggressivebutdisciplinedBD&LandstrategicM&A;royaltiesandpatentprotectionwithrespecttoVimovo®;theZontivity®opportunity,includingitspatentprotection,thePADandMItargetpopulations,;thesuccessfulexecutionoftherelaunchofZontivity,includingthatthephasedlaunchteamhaveshownimmediateresultsafterjustfiveweeksofdata,andthatZontivityisnicelypositionedforthefullscalelaunch;statementsregardingmanagedcareprogressforZontivity;thebenefitsofYosprala®;theYospralaopportunity,includingpatentprotection;therefinedcommercialstrategyforYosprala,includingcontinuedsalesforce promotionalongsideZontivity,supportforYospralawithdirectsellingeffortsonly,leveragingourmanagedcareposition,focusonimprovingpatientaccessandgrowingthebrand,andtheboldnewcompetitivepricingstrategyforYospralaessentialfordrivinggrowthandaimedatallowingallpatientstoaccessYospralaforonly$10permonth;Yospralacoverageonformularies;Yospralaprescriptiontrends; thebenefitsoftheToprol-XL®transaction,includingthatitcontinuestogeneralsignificantrevenueandprovidescashflowanditmeetsthestatedgoalofaddingimmediaterevenueandEBITDA(onan adjustedbasis);thatthetransitionoftheToprol-XLfranchisefromAstraZenecaisprogressingwellandexpectedtobecompletedDecember31,2017;statementsregardingtheVANationalContract forToprol-XL;effectivelymanagingtheToprol-XLfranchise;Canadianportfolioperformance,includingthatthebusinesscontinuestobeaprofitablesegmentonanadjustedEBITDAbasis,portfoliogrowthdriversincludingCambia®,Soriatane®andBlexten™,andadditionalfutureorganicgrowthdriverswiththepotentiallaunchofZontivityandYospralaregulatorysubmissioninCanada;strongearly launchperformanceforBlexten inCanada;our2017guidanceonAdjustedEBITDAandnetrevenues;maximizingfinancialflexibilitywithcontinuedfocusoncostandcashmanagement;exploringbothstrategicandfinancingoptionswithacontinuedfocusontransformativeM&A;andotherstatementsthatarenothistoricalfacts,andsuchstatementsaretypicallyidentifiedbyuseoftermssuchas“may,”“will,”“would,”“should,”“could,”“expect,”“plan,”“intend,”“anticipate,”“believe,”“estimate,”“predict,”“likely,”“potential,”“continue”orthenegativeorsimilarwords,variationsofthesewordsorothercomparablewordsorphrases,althoughsomeforward-lookingstatementsareexpresseddifferently.Youshouldbeawarethattheforward-lookingstatementsincludedhereinrepresentmanagement’scurrentjudgmentandexpectations,andarebasedoncurrentestimatesandassumptionsmadebymanagementinlightofitsexperienceandperceptionofhistoricaltrends,currentconditionsandexpectedfuturedevelopments,aswellasotherfactorsthatitbelievesareappropriateandreasonableunderthecircumstances,buttherecanbenoassurancethatsuchestimatesandassumptionswillprovetobecorrectand,asa result,theforward-lookingstatementsbasedonthoseestimatesandassumptionscouldprovetobeincorrect.Accordingly,actualresults,levelofactivity,performanceorachievementsorfutureeventsordevelopmentscoulddiffermateriallyfromthoseexpressedorimpliedintheforward-lookingstatements.Materialfactors,risksorassumptionsthatwereappliedortakenintoaccountinprovidingfinancialguidancefortheyearendingDecember31,2017,includingwithrespecttothestatementsthatAralez’s netrevenuesareexpectedtobeintherangeof$80millionto$100millionandAdjustedEBITDAisexpectedtobeintherangeof$(5)millionto$5million,include,butarenotlimitedto,thematerialfactorsandassumptionsoutlinedinthispresentationandunderthecaption“CautionaryNoteRegardingForward-LookingStatements”inourpressreleasedatedMay9,2017announcingresultsforthefirstquarterendedMarch31,2017.Readersarecautionedthatouractualfutureoperatingresultsandeconomicperformancearesubjecttoanumberofrisksanduncertainties,including,amongotherthings,thosedescribedbelow,andcoulddiffermateriallyfromwhatiscurrentlyexpected assetoutinthispresentation.Inaddition,ouroperationsand2017financialguidanceinvolverisksanduncertainties,manyofwhichareoutsideofourcontrol,andanyoneoranycombinationoftheserisksanduncertaintiescouldalsoaffectwhethertheforward-lookingstatementsultimatelyprovetobecorrectandcouldcauseouractualresults,levelofactivity,performanceorachievementsorfutureeventsordevelopmentstodiffermateriallyfromthoseexpressedorimpliedbytheforward-lookingstatements.Theserisksanduncertaintiesinclude,withoutlimitation,ourinabilitytomaintainasalesforceofsufficientscaleforthecommercializationofourproductsinatimelyandcost-effectivemanner;ourfailuretosuccessfullycommercializeourproductsandproductcandidates;competition,includingincreasedgenericcompetition;costsanddelaysinthedevelopmentand/orapprovalofourproductcandidates,includingasaresultoftheneed to conductadditionalstudiesorduetoissueswiththird-partyAPIorfinishedproductmanufacturers,orthefailuretoobtainsuchapprovalofourproductcandidatesforallexpectedindications,includingasaresultofchangesinregulatorystandardsortheregulatoryenvironmentduringthedevelopmentperiodofanyofourproductcandidates;withrespecttocertainproducts,dependenceonreimbursement fromthird-partypayors andthepossibilityofafailuretoobtaincoverageorreductionintheextentofreimbursement;theinabilitytomaintainorenterinto,andtherisksresultingfromourdependenceupon,collaborationorcontractualarrangementsnecessaryforthedevelopment,manufacture,commercialization,marketing,salesanddistributionofanyproducts,includingourdependenceonAstraZenecaABandHorizonPharmaUSA,Inc.forthesalesandmarketingofVimovo,ourdependenceonPatheon PharmaceuticalsInc.forthemanufactureofYosprala,ourdependenceonSchering-Plough(Ireland)CompanyforthesupplyofZontivityandourdependenceonAstraZenecaABforthemanufactureandsupplyofToprol-XLanditscurrentlymarketedauthorizedgeneric(AG);ourdependenceon maintainingandrenewingcontractswithcustomers,distributorsandothercounterparties(certainofwhichmaybeundernegotiationfromtimetotime),includingourinabilitytorenewexisting contractsonfavorableterms,andtherisksthatwemaynotbeabletomaintainourexistingtermswithcertaincustomers,distributorsandothercounterparties;ourabilitytoprotectourintellectualpropertyanddefendourpatents;regulatoryobligationsandoversight;failuretosuccessfullyidentify,execute,integrate,maintainandrealizeexpectedbenefitsfromnewacquisitions,suchastheacquisitionsofTributePharmaceuticalsCanadaInc.,ZontivityandToprol-XLanditsAG;failuretorealizetheexpectedbenefitsofourinitiativestoreducecostsandimproveprofitability;fluctuationsinthevalue ofcertainforeigncurrencies,includingtheCanadiandollar,inrelationtotheU.S.dollar,andotherworldcurrencies;changesinlawsandregulations,includingtaxlawsandunanticipatedtaxliabilitiesand regulationsregardingthepricingofpharmaceuticalproducts;risksrelatedtoourfinancingandliquidity;generaladverseeconomic,marketandbusinessconditions;andthoserisksdetailedfromtime-to-timeunderthecaption“RiskFactors”andelsewhereinourSecuritiesandExchangeCommission(SEC)filingsandreportsandCanadiansecuritieslawfilings,includinginourAnnualReportonForm10-KfortheyearendedDecember31,2016andourQuarterlyReportonForm10-QforthequarterendedMarch31,2017,whichareavailableonEDGARatwww.sec.gov,onSEDARatwww.sedar.com,andonourwebsiteatwww.aralez.com,andthosedescribedfromtimetotimeinourfuturereportsfiledwiththeSECandapplicablesecuritiesregulatoryauthoritiesinCanada.Youshouldnotplaceundueimportanceonforward-lookingstatementsandshouldnotrelyuponthisinformationasofanyotherdate.Weundertakenoobligationtopubliclyupdateorreviseanyforward-lookingstatements,whetherasaresultofnewinformation,futureeventsorotherwise,unlessrequiredbylaw.ThispresentationwasprovidedonJune7,2017aspartofanoralpresentationandisqualifiedthereby.

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TheAralez InvestmentThesis

Aralez isanemergingglobalspecialtypharmaceuticalcompanydesignedto:• Maximizethevalueofabroadenedportfolio,growingrevenuebaseandgeographicfootprintacrossNorthAmericaandEurope• Buildonanchorpositionsincardiovasculardiseaseandpainmanagementandopportunisticallyexpandintootherspecialtytherapeuticareas• AccesshighpotentialgrowthopportunitiesthroughaggressivebutdisciplinedBD&LandstrategicM&A• Buildvalueorganicallyandleveragecompetitiveplatformtoacceleratetransformationandexecutegrowthstrategy• Maintainalean,nimbleandperformance-orientedoperatingmodel• Alignwithshareholderinterestswithastrongfocusoncreatingshareholdervalue

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OurJourneySoFar

CompletedthemergertoformAralezRe-launchedandgrewFibricor®useintheU.S.BuiltsalesforceuponFDAapprovalofYospralaLaunchedYosprala®inOctober2016intheU.S.Acquiredtwonewcardiovascularproducts– Zontivity®andToprol-XL®anditsAuthorizedGeneric(AG)Exceededoriginal 2016financialguidanceLaunchedBlexten™inDecember2016inCanadaSubmittedYospralaforEUapprovalinJanuary2017InitiatedZontivityphasedlaunchofZontivityinApril2017

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Aralez:OurBaseBusiness

• CanadianRevenueBase– KeycontributorsincludeCambia®,Soriatane®andBlexten™

•U.S.RevenueBase– OngoingroyaltystreamonsalesofVimovo®;potentialpatentprotectionuntillate2031

– Fibricor®promotionbeganApril2016

– Zontivity®acquiredfromMerckonSept.6,2016;Compositionofmatterpatentto2024,potentialpatenttermextensionthrough2027

– Yosprala® launchedonOct.3,2016;Patentedtolate2032withpossibletermextensionto2033

– Toprol-XL® acquiredfromAstraZenecaonOct.31,2016

Note:2015proformarevenuesincludeproformarevenuesforTributeNote:2016proformarevenuesincludeTributerevenuesforfullyear2016,includingtheperiodJanuary1sttoFebruary5th,the dateofthemerger,aswellasactualnetrevenuesforZontivity,fromSeptember6,2016,andToprol-XL,fromOctober31,2016

AllnumbersU.S.$M

$-

$10.0

$20.0

$30.0

$40.0

$50.0

$60.0

2015ProFormaRevenues

(Pozen&Tribute)

2016ProFormaRevenues

AralezProFormaRevenues

$45.1M

$56.3M

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Zontivity:NowFullyLaunched

Importantsafetyinformationavailableathttp://aralez.com/Portfolio/zontivity/

Zontivity isaprotease-activatedreceptor-1(PAR-1)antagonistindicatedforthereductionof

thromboticcardiovasculareventsinpatientswithahistoryofmyocardialinfarction(MI)orwithperipheral

arterialdisease(PAD)

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AntiplateletPrescribingInformationHighlights

ZONTIVITY Clopidogrel(Plavix®)

Ticagrelor(Brilinta®)

Prasugrel(Effient®)

Indicated Patients PADorhistory ofMIACS,recentMI,recentstrokeorestablishedPAD

ACSorhistoryofMI ACSpatientsmanagedwithPCI

Dose 1tabletoncedaily 1tabletoncedaily 1tablettwicedaily 1tabletoncedaily

Mechanism ofAction PAR-1 inhibitor P2Y12platelet

inhibitorP2Y12plateletinhibitor

P2Y12plateletinhibitor

Other AntiplateletUse

UsewithASA and/orclopidogrel

MayusewithorwithoutASA

UsewithASA75-100mg

UsewithASA75-325mg

BoxedWarning Yes Yes Yes Yes

Contraindications

Historyofstroke,TIA, orICH;Active

pathologicalbleeding

Activepathologicalbleeding;

Hypersensitivity

History ofICH;Activepathological

bleeding;Hypersensitivity

Activepathologicalbleeding;PriorTIA

orstroke;Hypersensitivity

AdverseReactions(Highlights)

Bleeding,includinglifethreatening andfatalbleeding,isthemostcommonlyreportedAE.

Bleeding,includinglifethreatening andfatalbleeding,is

themostcommonlyreportedAE.

The mostcommonadversereactionsarebleeding12%anddyspnea14%.

Bleeding,includinglifethreatening andfatalbleeding,is

themostcommonlyreportedAE.

Informationfromprescribinginformationhighlightsonly.Thesedrugswerenottestedincomparisontooneanother.MI-myocardialinfarction;PAD-peripheralarterydisease;ACS-acutecoronarysyndrome;TIA-transientischemicattack;ICH-intracranialhemorrhagePCI-percutaneouscoronaryintervention;ASA-aspirin;AE-adverseeventImportantsafetyinformationavailableathttp://aralez.com/Portfolio/zontivity/

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PADonlyplusPAD&MI3,5,6,7

Zontivity:PADandMITargetPopulations

MIPrevalencew/oPAD(>20years)2

6.8M

Smoking(66%)and/orDiabetic(24%)Patients1,8

7.4M

1Pandeetal.,SecondaryPreventionandMortalityinPeripheralArteryDiseaseNationalHealthandNutritionExaminationStudy,1999to2004,2011.2MozaffarianD,BenjaminEJ,GoAS,etal.Heartdiseaseandstrokestatistics—2016update.3Bonacaetal.,Ticagrelorforpreventionofischemiceventsaftermyocardialinfarctioninpatientswithperipheralarterydisease,2016.4Wallentinetal,TicagrelorversusClopidogrelinPatientswithAcuteCoronarySyndromes,2009.5Comparisonofglobalestimatesofprevalenceandriskfactorsforperipheralarterydiseasein2000and2010:asystematicreviewandanalysis,2013.6USDepartmentofHealthandHumanServices,FactsaboutPeripheralArteryDisease,2006.7USPSTF:(PAD)andCVDinAdults:RiskAssessmentwithABI,2013.8HeartDiseaseandStrokeStatistics—2016UpdateImportantsafetyinformationavailableathttp://aralez.com/Portfolio/zontivity/

4.8M

Smoking(24%for20-60yrs,23%for60+yrs)and/orDiabetic(43%for20-60yrs,71%for

60+)1,8

4.2M

MarketOpportunity(LabeledPopulation)

14.2M

PersistentRisk(FocalPopulation)

9M

ZontivitywillbepositionedforPADpatientsand/orpost-MIpatientswithafocusonpersistentriskpatients

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0

20

40

60

80

100

5WeeksPre 5WeeksPost

NRxGrowthTargetedHCPs

Zontivity:Phase1oftheLaunch

• Phase1commencedonApril24th:15repsdeployedtohighvolumetargetswhotreatpost-MIandPADpatients• ThePhasedLaunchTeamhaveshownimmediateresultsafterjust5weeks• 195HCPshavebeencalledonbytheteamofwhich86werepriorwritersofZontivity• Salesforceadded18newwritersforZontivityduringthelast5weeks• 65%ofnewwriterswerecardiologists• Ofthe75NRxinthelast5weeks,42%camefromthenewwritersandarethedriverofpostlaunchgrowth

HCPdatathruweekending5/12187TargetedHCPs

+98% Growth 5 Weeks Post

Phased Launch

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10

0

20

40

60

80

100

120

140

NRX

ZontivityWeeklyNRx

Zontivity:NicelyPoisedforFullScaleLaunch

MerckStoppedPromotion

SamplingWriters

PhasedLaunch

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Zontivity:ManagedCareProgressUpdate

ManagedCareUpdate• Enhancedmanagedcarecoveragesinceacquisition• Zontivityiscoveredfor~85%ofCommercialLives*• The4largestPBMsintheU.S.arecoveringZontivity,withthemajorityofdownstreamclientsdoingsowithoutaPriorAuthorization– Lessthan15%ofcommercialliveswithaPA;expectedtodropto7-8%inthenearfuture

– MajorityofexistingPA’saretolabel• MixofTier2andTier3coveragewithcopaymitigationprogramsinplace• DiscussionsareongoingwiththefewremainingPayerstoenhanceZontivity’sformularyposition

*ExcludesMedicaidandothergovernmentprograms

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Yosprala:CommercialStrategy

U.S.MarketOpportunityYosprala:Single,OnceDailyTablet

FormulatedtoMinimizeAspirin-RelatedGIToxicityWhileDeliveringaComparableDoseofAspirinviatheProprietaryIntelli-COAT™System

MarketOpportunity• ~26.2Msecondarypreventionpatients1

– ~18.3Mor70%takeaspirin2

– ~6.3MtakeaspirinplusaPPI/H23

RefinedCommercialStrategy• ContinuesalesforcepromotionofYospralaalongsideZontivity• Leverageourimprovingmanagedcareposition• Focusonimprovingpatientaccessandgrowingthebrand• BoldnewcompetitivepricingstrategyforYospralaisessentialtodrivegrowth– Aimedatallowingallpatientstoaccess

Yospralaforonly$10permonth

1Mozaffarian D,HeartDiseaseandStrokeStatistics– 2015Update.2FangJ,UseofLow-doseAspirinasSecondaryPreventionofAtheroscleroticCVDamongUSadults(FromtheNationalHealthInterviewSurvey,2012),2015.3Tran-DuyA,ShouldPatientsPrescribedLong-termLow-DoseAspirinReceiveProtonPumpInhibitors?ASystematicReviewandMeta-analysis,2015.

Importantsafetyinformationavailableatwww.yosprala.com

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YospralaPerformance&ManagedCareUpdate

1Source:SymphonyHealth,RPE=RetailPrescriptionEquivalent

• SupportYospralawithdirectsellingeffortsonlyandleveragemanagedcareposition• Numberofrejectionsdownfromover60%to~30%

75%

39%

11%

14%

61%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90%

100%

Commercial MedicareCo

veredLives

Covered Covered(PA/ST) NotCovered

ManagedMarketsInsights&Technology 2CoverageonFormularies

2CommercialSource:MMITFebruary20173 MedDSource:InternalEstimateBasedonCommittedPartDLivesas%ofTotalPartDLives

30

500

1,000

1,500

2,000

2,500

YospralaPrescriptionsRolling4WeekSum

RPE NRx TRx

NewPricingStrategy

Announced

1

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Toprol-XL:SignificantFinancialBenefits

StrategicRationale&Benefits:• Establishedbeta-blockerwithstableprescriptionbase• MeetsstatedgoalofaddingimmediaterevenueandEBITDA*

Transition&ProductPerformanceUpdate:• TransitionprogressingwellandcompletionexpectedinDecember31,2017• Aralezrecordsrevenuesnetofcostofsalesandtransitionservicesfeesduringthetransitionperiod• VAhasexerciseditsoptiontorenewtheNationalContract;extendedtoApril28,2018atreducedpricingprovidingstable,brandedVAbusinessfortheduration

ImportantSafetyInformationAvailableatToprol-XL.com

*Onanadjustedbasis

ContinuestoGenerateSignificantRevenueandProvidesCashFlow

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Aralez:CanadianPortfolioPerformance

• CanadianbusinesscontinuestobeaprofitablesegmentofourbusinessonanadjustedEBITDAbasis• PortfoliogrowthdriversincludeCambia,Soriatane,andBlexten grew~39%in1Q17vs1Q16*• Blexten launchexceedingexpectations• AdditionalpossiblefutureorganicgrowthdriverswiththepotentialZontivity launchandYospralaregulatorysubmission

AllnumbersU.S.$M

CanadianPortfolioNetRevenue

31%

$5.7M

GrowthProductsOtherProducts

*Reflectsfullquarterofnetproductrevenueson(aproformabasis)fromCanadianproductsin1Q16

69%

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Blexten:StrongEarlyLaunchPerformance

0

142

829

2,107

3,897

6,025

141804

1,947

3,348

5,059

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

Nov-2016 Dec-2016 Jan-2017 Feb-2017 Mar-2017 Apr-2017

BlextenTRx BlextenNRx

Source:QIMSCompuScript Apr-2017

• Blexten launchedinCanadaonDecember19,2016• IndicatedforthetreatmentofthesymptomsofSeasonalAllergicRhinitis(SAR)and

ChronicSpontaneousUrticaria (CSU)(suchasitchinessandhives)

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$4.5 $3.7

$3.3 $5.7

$16.6

$0

$5

$10

$15

$20

$25

$30

Q12016 Q12017

Amou

ntsinUS$M

VimovoRoyalties CanadianProducts CoreBusiness

$8.1M

1Q2017RevenueGrowth

$26.0M

Note1:Q12016NetProductRevenuesof$3.6millionconsistedofnetrevenuesfromthesaleofCanadianproducts($3.3million)andFibricor($0.3M)fortheperiodFebruary5,2016(dateoftheTributeacquisition)throughMarch31,2016.

Note2:CoreBusinessincludesnetrevenuesfromZontivityandToprol-XL(anditsAG),whicharereportednetofcostsandtransitionservicesfeesduringthetransitionperiod,andnetproductsalesfromFibricorandYosprala.

(Option2)

+$17.9M

$0.3

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2017FinancialGuidance

Measure 2016Actuals 2017Guidance

NetRevenues $54M $80Mto $100M

Adjusted EBITDA* ($47M) $(5M)to$5M

*AdjustedEBITDAisdefinedasnetincome(loss)beforeincometaxes,interestexpenseandfinancingcosts,depreciationandamortization,stock-basedcompensation,gainsorlossesrelatedtowarrants,changestothefairvalueofcontingentconsideration,restructuringcosts,retentionandseverancecosts,impactofanacquisitionofabusinessorproduct,includingtransactioncosts,acquiredin-processR&D,taxequalizationpayments,interestincome,theimpactofchangesinforeigncurrencyrates,assetimpairmentcharges,lossesorgainsonsaleofassets,lossesorgainsonextinguishmentormodificationofdebtandtheimpactofasaleordispositionofabusinessorproduct,includingdiscontinuedoperations.

GAAPtoNon-GAAPreconciliationsareincludedwithinthetablesaccompanyingourpressreleaseattachedasanexhibittoourCurrentReportonForm8-KfiledonMay9,2017,copiesofwhichareavailableonEDGARatwww.sec.gov,onSEDARatwww.sedar.com andonourwebsiteatwww.Aralez.com.

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Aralez– CorporateFocusGoingForward

•Maximizingourfinancialflexibilitywithcontinuedfocusoncostandcashmanagement

•SuccessfulexecutionofZontivityrelaunch•StrongercommercialexecutionwithYosprala

•EffectivelymanageToprol-XLfranchise

•WeareexploringbothstrategicandfinancingoptionswithacontinuedfocusontransformativeM&A

ShareholderValueCreation

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“CorporateOverview&StrategicVision”Jefferies HealthcareConference

June7, 2017


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