Beruflich Dokumente
Kultur Dokumente
19th December,2016
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GlenmarkTeam
Conditionforoffer
success
Conditionforoffer
success
Conditionforoffer
success
RobertMatsuk
GlennSaldanha
Dr. FredGrossman
President
NorthAmerica+API
Chairman&MD
Conditionforoffer
success
President
ChiefMedicalOfficer
Conditionforoffer
success
Dr. KurtStoeckli
PGanesh
President
ChiefScientificOfficer
President
ChiefFinanceOfficer
Agenda
Journeyoverthelast15years
StrategicRoadmap
GlobalGenericsBusiness
ResearchandDevelopment
OverviewofKeyAssets
Financials
Summary
Agenda
Journeyoverthelast15years
StrategicRoadmap
GlobalGenericsBusiness
ResearchandDevelopment
OverviewofKeyAssets
Financials
Summary
Evolvedintoasuccessfulglobalorganizationoverthe
last15years
Year2000
WealthCreation
Manufacturing
Footprint
International
Operations
Year2016
Revenue:US$31mn
Revenue:US$1.2bn
MarketCap.:US$40mn
MarketCap:US$3.9bn
2formulationsfacilities
17 facilities across4continents;7
approvedbyUSFDA
~8%oftotalrevenues
>70% oftotalrevenues
PresentinUS,EU,RCIS,LATAMetc.
Novelmoleculesinpipeline
Innovation
InitiationofNMEresearch
FocusedonOncology,Dermatology
andRespiratory
Employees
<1,000:PrimarilyinIndia
>12,000:Spreadover50countries
CurrentbusinessisspreadacrossAPI,Brandedand
GenericFormulations
FormulationsDevelopmentandMarketing
APIManufacturing
&Marketing
NME& Specialty
BrandedFormulations
GenericsFormulations
BrandBuildingin
SelectedTherapies
SubstitutionModel
CaptiveConsumption
andExternalSales
Biologicsand
SmallMolecules
Keygeographies
Keygeographies
Keygeographies
Keyfacilities
India
NorthAmerica
NorthAmerica
Russia&CIS
WesternEurope
Europe
LatinAmerica
Japan
Asia
India
Africa
LatinAmerica
CEE
Revenuegeneratingsegments
Switzerland
Dedicatedcenterfor
biologics
India
R&DcenterforNCEs
Developmenthub
forspecialty
Investingforthe
future
Robustgrowthexhibitedacrossbusinesssegments
NetRevenues(INRbn)
CAGR:
19%
CAGRof19%overlastfiveyears
Branded
Formulations
FocusedonbrandbuildinginselectTAs
Strongfieldforceof5,500+ globally
19.0
FY12
29.0
33.3
37.6
24.7
FY13
FY14
FY15
FY16
NetRevenues(INRbn)
CAGR:
20%
CAGRof20%overlastfiveyears
Generic
Formulations
Growthdrivenbynicheproductsand
selectedlargescaleopportunities
LeadingGxdermaplayerintheUS
15.1
FY12
20.6
FY13
25.3
26.8
FY14
FY15
31.4
FY16
NetRevenues(INRbn)
CAGR:
21%
CAGRof21%overlastfiveyears
API
Leadershippositioninmultipleproducts
Filed~200DMFsinvariousmarkets
Note:NetrevenuesinGenericsFormulationschartincludeUS,WEUandCEE
3.1
4.0
FY12
FY13
5.4
6.1
6.7
FY14
FY15
FY16
InitiatednovelR&Din2000withavisiontobring
innovativemoleculestomarket
GBR1302:Firstbispecific
antibodyentersclinic
2016
GBR830entersPhase2
2015
SCRIPAwardforBest
OverallPipeline
20062007
2000
2012
Swissmedic approvalfor
GMPmanufacturing
20102011
NBER&Dcenterin
Switzerland
Initiationof
NCER&D
2014
Filedforpatent
onBEAT
20042005
Outlicensingdeals
withSanofi
OutlicensingdealswithEli
LillyandMerck
Outlicensingdeals
withForestandTeijin
Sevenoutlicensingdealssince2004,withcumulativerevenuesofUS$200+mn
10
Manufacturingnetworkspreadover4continents;
7facilitiesapprovedbytheUSFDA
CommissionedUSmanufacturingsitein2016andobtainedDEAlicenseforcontrolledsubstances
ANDAfilingfromCY17onwards
VysokeMyto,
CzechRepublic
Monroe,USA
Neuchatel,
Switzerland
8 FormulationFacilities&5
APIFacilities
India
FormulationFacility
APIFacility
Goa
Ankleshwar
USFDAApproved
Indore
Dahej
BiologicsFacility
Baddi(2)
Aurangabad(A+F)
Nalagarh
Kurkumbh
Nashik
Mohol
Pilar,Argentina
Sikkim
11
Agenda
Journeyoverthelast15years
StrategicRoadmap
GlobalGenericsBusiness
ResearchandDevelopment
OverviewofKeyAssets
Financials
Summary
12
Strategicelementstoovercomethekeychallenges
facedbythePharmaceuticalsIndustry
IndustryChallenges
StrategicElements
Declineinsmallmoleculegenerics
opportunitiesintheUS
Focuson3coretherapyareas
Oncology,DermatologyandRespiratory
Increaseincompetitivelandscapedue
toentryofnewplayers
Continuetogrowgenericsbusiness
throughdifferentiatedproductsand
launchspecialtyandinnovative
products
Consolidationofcompetitorsand
customerbaseintheUSandEU
Pricingpressureindevelopedmarkets
drivenbyneedtomanagehealthcare
budget
Pushtowardslocalmanufacturingof
genericsinkeyemergingmarkets
Enhancedevelopmenteffortsonniche
generics andcomplextechnologies
suchassemisolidsandHormones
Enternewdosageformswithlow
competitiveintensitye.g.Inhalers
AdvanceNMEpipelineandcontinueto
lookforpartneringopportunities
13
Roadmaptoevolveintoainnovativeresearchledfirm
andlaunchproprietaryproducts
US,India,EuropeandAPI
tocontribute>80%of
sales
Increasepresencein
complexgenerics
2majorgeographies US
andIndiacontributing~60%
ofsales
Genericformulationplayer
intheUSandWEU
Brandedformulationin
othermarkets
NMEpipelineinearlyto
midstageofdevelopment
Manufacturingbase
primarilyinIndia
Currentposition
Launchinnovativeand
specialtyproductsin
multiplemarkets
~30%oftotalrevenues
fromspecialtyand
innovationsegments
Launchspecialtybusiness
intheUS
NMEpipelineinadvanced
stageofdevelopment
Expandmanufacturing
footprint
Mediumtermfocus
(next35years)
Longtermfocus
(next510years)
14
Agenda
Journeyoverthelast15years
StrategicRoadmap
GlobalGenericsBusiness
ResearchandDevelopment
OverviewofKeyAssets
Financials
Summary
15
Indiabusinesstargetingtodominateselectedtherapies
andgrowfasterthanoverallmarket
Robustgrowthexhibitedinthelastfiveyears
KeyGrowthDriversinthenext45years
NetRevenues(INRmn)
Strengthenpresenceinlargeandfast
growingtherapies
13,096
CAGR:
20.4%
21,093
17,490
15,105
Dermatology,Cardiac,AntiDiabetic,
RespiratoryandOncology
10,021
FY12
FY13
FY14
FY15
FY16
Consistentlygrowingat>1.5xofIPMgrowth
Leveragerecentlylaunchedproductssuch
asTeneligliptinandDigihaler
29%
20%
14%
14%
9%
Oct'12
Oct'13
IPMgrowth
12%
Oct'14
20%
15%
Continuetobuildstrongbrands 8brands
amongsttop300intheIPM
19%
12%
Oct'15
Oct'16
Glenmarkgrowth
Source:IMSTotalSalesAuditMATOct16.IPM:IndianPharmaceuticalsMarket
Introduceinnovativeproductsincore
therapyareas Internaldevelopmentand
Inlicensing
GrowOTCbusinessthroughfocuson
existingbrandslikeVwashandCandid
Powderandnewlaunches
16
Niche,complexgenericstodrivegrowthinEurope
Stronggrowthexhibitedinthelastfiveyears
NetRevenues(INRmn)
CAGR:
24.3%
6,445
7,171
5,061
3,008
3,724
KeyGrowthDriversinthenext45years
Leverageexistinginfrastructureand
maximizevaluefromexistingmarkets UK,
DE,CEE
Selectivelyenter12marketsprimarilyin
thetendersegmente.g.EnteredSpainin
FY16
Wideportfolioofproducts
Focusonproducts,technologieswith
limitedcompetitiveintensity
Others,
26%
Lookingtolaunchcomplexgenericproducts
inthenearfuture
FY12
FY13
FY14
Top10,
43%
FY15
FY16
Topproducts:
Nebivolol
Perindopril
Aripiprazole
Atovaquone+Proguanil
Pregabalin
Quetiapine
Telmisartan
Ataralgin
Top21
30,11%
Top11
20,20%
e.g.InlicensedgSeretide(DPI)for15
countrieswithmarketsizeofUS$~700mn
ExpectedtolaunchinFY18
Continuetoleverageinlicensingeffortsto
strengthentheportfolioinadditionto
internaldevelopmentefforts
17
LATAMandRoWgrowthtobedrivenbylargemarkets
andfocusoncoretherapies
LATAM
KeyGrowthDriversinthenext45years
NetRevenues(INRmn)
3,012
3,468
CAGR:
26%
7,640
7,495
LATAM
Leveragepresenceinlargemarketssuchas
Brazil,MexicoandArgentina
4,046
Strengthenpresenceincoretherapyareas
Dermatology,RespiratoryandOncology
FY12
FY13
FY14
FY15
FY16
RoW(Russia,Asia,AfricaandCIS)
BusinesstoturnprofitablefromFY18
onwards
RestofWorld(RoW)
NetRevenues(INRmn)
CAGR:
11%
9,869
8,123
8,122
9,033
KeymarketsintheregionincludeRussia,
Malaysia,Philippines,KenyaandSouthAfrica
Limitfrontendpresencetoexistingmarkets
(~900fieldforce)andusepartnershipsin
othermarkets
5,926
Strengthenpresenceinselecttherapiesand
launchdifferentiatedproducts
FY12
FY13
FY14
FY15
FY16
18
Launchofniche,complexgenericsandspecialty
productstodriveUSBusiness
Revenuesdoubledinthelast5years
Netrevenue(INRmn)
KeyGrowthDriversinthenext45years
SoleFTFgZetialaunchedon12th December
CAGR:
19%
24,203
20,398
20,270
16,887
12,137
Largeproductportfolio:110+ANDAs
approved,60+underapprovaland75+in
development
Top10productsaccountfor~45%ofsales
andTop20accountfor~60%n
FY12
FY13
FY14
FY15
FY16
WelldiversifiedPortfolio
Mupirocin Crm (14.7%)
Pravastatin (9.5%)
Gabapentin (6.6%)
Targetingtofile2025ANDAsandlaunch
1020productsannually
Leverageexpertiseinthedermatology
segment 15+ANDAspendingforapproval
and20+productsindevelopment
Omeprazole (2.9%)
Naproxen Sodium (2.2%)
Naproxen (1.96%)
Ursodiol (1.94%)
Ranitidine (1.91%)
Oxcarbazepine (1.79%)
Desmopressin Tab (1.77%)
Others (54.6%)
Source:IMSNSPMATOct2016fortheUSmarket
Enhancequalityofpipelinethrough
additionofcomplexgenericsandniche
technologies
Launchofspecialtyrespiratoryproductsin
thenext34years
19
Internalcapabilitiesandexternalpartnershipstodrive
highqualitypipeline
DistributionofANDAsfiled(Count)
Hormones
(Orals)
15%
OptimalcombinationofinternalR&Dand
strategicdevelopmentpartnerships
FY1216
OralSolids
46%
Onco
Injectables
18%
Launchofinhalersinthenext34years
Workingon2additionalnewdosageforms,with
potentiallaunchinCY18andCY19
Topicals
21%
Control
Substances
7%
~15inlicensingdealseithersignedorinadvance
discussionstage
FY1721
OralSolids
22%
Drug+
Device
16%
Hormones
8%
Onco
Injectables
12%
Targetingmultiplenewdosageformsto
differentiateagainstcompetition
Focusonsigningglobaldeals:Expectedtolaunch
productsfromCY17onwards
Totalmarketsizeofdealssignedorunder
discussionsisUS$~12bn
Topicals
35%
Agreementsalreadyexecutedincludeproducts
suchasgAbraxane,gNuvaring andgSuboxone
20
Selectedlargeandcomplexgenericproductsinpipeline
fortheUSmarket
Product
MarketSize
(US$bn)
Source
FilingStatus
Filed
CY17
CY18
CY19
gWelchol
0.6
Inhouse
gRenagel
2.1
Inhouse
gVagifem
0.4
Inhouse
gConcerta
1.8
Inlicense
gAbraxane
0.7
Inlicense
gSuboxone
1.6
Inlicense
gNuvaring
0.8
Inlicense
GSP101(GxInhaler)
~4.5
Inhouse
GSP103(GxInhaler)
~1.0
Inhouse
GSP104(GxInhaler)
~0.8
Inhouse
Note:MarketsizebasedonIMSNSPMATOct2016fortheUSmarket.Aboveproductlistisnotexhaustive
21
DevelopedmarketstodrivegrowthinAPIbusiness
Robustgrowthoverlastfiveyears
Revenue(INRmn)
KeyGrowthDriversinthenext45years
6,683
CAGR:
21%
5,353
6,053
3,976
5APIplantstomeetexternaldemandand
internalrequirements
Leadershippositioninmultipleproducts
suchasAmiodarone,Lercanidipine,
AdapaleneandPerindopril
3,094
File78USDMFsannually
FY12
FY13
FY14
FY15
FY16
Primarilytargetingformulationplayers
focusedonmarketslikeUSandEurope
~200DMFfilingsacrosskeymarkets
Strengthenpresenceinselectnewmarkets
suchasJapan
90
Focusondifferentiatedproducts andcost
competitiveness
39
23
US
EDMF
CEP
20
Canada
12
12
Japan
Australia
Backwardintegrationtoderiskthesupply
chainanddriveprofitability
22
Agenda
Journeyoverthelast15years
StrategicRoadmap
GlobalGenericsBusiness
ResearchandDevelopment
OverviewofKeyAssets
Financials
Summary
23
R&Dcapabilitiesacrossthevaluechain
EndtoEndR&Dcapability NewChemicalEntities,NovelBiologics,GenericAPIsandFormulations
GenericAPI
Supportsbothinternalandexternalmarket
demand
~200DMFsfiledacrosskeymarkets:US,
Europe,Japanetc.
GenericandSpecialtyFormulations
PrimarilybasedoutofIndia
Dosageforms Solids,Semisolids,Inhalers,
oralliquids,parenteraletc.
FocusonNovelDrugDeliverySystems(NDDS)
Abilitytodevelopandscaleupmoleculeswith
complexchemistry
NovelChemicalEntities
NovelBiologics
Teamof350+involvedinR&DonNCEs
Teamof110+involvedinNBER&D
Targetselectiontoclinicaldevelopment
Monoclonalantibodiestobispecificand
multivalentantibodies
KeyTAs:Respiratory,inflammatorydisorders
EvaluationofNovelSMimmunomodulatorsin
ImmunoOncology
ProprietarytechnologyPlatform:BEAT
KeyTAs:OncologyandImmunology(Derma)
SupportedbyGlobalClinical,Regulatory,ProgramManagementandBusinessDevelopmentFunctions
24
BiologicsResearchCentreinSwitzerland Key
capabilities
CellLineDevelopment
UpstreamDevelopment
DevelopmenttargetedtomeetEMEA&USFDA
guidelinesonbiologics
GMPmanufacturingsiteapprovedby
Swissmedic inAug2014
BioassayDevelopment
Analytical&QCSupport
AntibodyEngineering
DownstreamDevelopment
Formulation&Stability
Capabilities
Targetevaluationtocandidatediscovery
Developmentofplatformtechnologies
Processdevelopment(upto250Lscale)
GMPmanufacturingforclinicaltrials
25
Focusingacrossthevaluechainincoretherapyareas
Oncology
Dermatology
Respiratory
Specialty/ComplexGx
Generics
OncologyinjectablesinEMs
9oncologyinjectablesfiled
inUS;LaunchfromFY18
onwards
Ranked#2inIndia
OneoftheleadersintheUS
Gxmarket Launched30+
products
LaunchedinhalersinEMs
InlicensedgSeretideforEU
3 inhalersindevelopment
forUS
LicensedgAbraxane;FY19
filing
Internallydevelopingother
complexinjectables
Launchedunique
combinationsinIndia,EMs
Assetsindevelopmentfor
theUS
3Specialtyprogramsin
pipelineforUS 1inP3
Uniquecombinationsand
devicesinIndia,otherEMs
InnovativeProducts
Focusedonbispecificand
multivalentantibodies
Fourprogramsinclinicalor
latepreclinicalphase
GBR830,targetingatopic
dermatitis,inphase2
Otherautoimmune
disordersunderevaluation
Assetstargetingrespiratory
disordersinlatediscovery
stage
DiseaseAreas:COPD,IPF
26
OverallNMEandSpecialtypipeline
Therapy
Molecule
MoA/Class
Indication
Oncology
GBR1302
HER2XCD3
BreastCancer
GastricCancer
Oncology
GBR1342
CD38XCD3
MultipleMyeloma
Oncology
GBR1372
EGFRXCD3
ColorectalCancer
Oncology
GBR8383
OX40RAgonist
MultipleCancers
Dermatology GBR830
Pre
Clinical
Phase1
Phase2
Phase3 Approval
OX40Antagonist AtopicDermatitis
Respiratory
GRC388XX
Undisclosed
COPD,IPF
Respiratory
GSP301
Steroid+AH
AllergicRhinitis
Respiratory
GSP304
LAMA
Respiratory
GBR310
Biosimilar
Asthma,CIU
Pain
GRC27864
mPGES1
ChronicPain
COPD
Note:NoncoreassetssuchasGRC17536,GBR900,GBR500deprioritizedforanyfurtherinvestment.These3andGRC27864are candidatesforoutlicensing
27
Agenda
Journeyoverthelast15years
StrategicRoadmap
GlobalGenericsBusiness
ResearchandDevelopment
OverviewofKeyAssets
Financials
Summary
28
Assetsindevelopment:Oncology
Therapy
Molecule
MoA/Class
Indication
Oncology
GBR1302
HER2XCD3
BreastCancer
GastricCancer
Oncology
GBR1342
CD38XCD3
MultipleMyeloma
Oncology
GBR1372
EGFRXCD3
ColorectalCancer
Oncology
GBR8383
OX40RAgonist
MultipleCancers
Dermatology GBR830
OX40Antagonist AtopicDermatitis
Respiratory
GRC388XX
Undisclosed
COPD,IPF
Respiratory
GSP301
Steroid+AH
AllergicRhinitis
Respiratory
GSP304
LAMA
Respiratory
GBR310
Biosimilar
Asthma,CIU
Pain
GRC27864
mPGES1
ChronicPain
COPD
Pre
Clinical
Phase1
Phase2
Phase3 Approval
29
Multiplebispecificantibodiesunderdevelopment
targetingunmetneedsinoncology
Proprietarytechnologyplatform(BEAT)fordevelopingnovelbispecificantibodies Tumor
killingactivitybasedonRedirectedLysis(RDL)ofTumorCellsbyTcells
GBR1302:HER2XCD3
CD3 binder
HER2binder
KeyfeaturesofBEAT
Efficiency intransferringtumor
antigenbindingscFvsinto
BEATformat(plug&play)
Flexibility beyondCD3
mediatedengagement
immunocytes
NoProteinA
binding
ProteinAbinding
++
Robustnessandscalability of
platformsimilartostandard
mAbproduction
HeterodimericBEATCH3interface
ProgramssuchasGBR1342andGBR1372arebasedonsimilarstructureandmechanism
30
GBR1302(BreastandGastricCancer)
SuperioritytocurrenttargetedmAbs
RedirectedLysisassays
Her23+breastcarcinoma
2+breastcarcinoma
GBR1302
50
100
% specific killing
100
50
-50
Kadcyla(2nd Line)
Herceptinor
Herceptin+Perjeta
(1st Line)
ColonyformingassayafterRDLonagastriccarcinoma3+
NCI N87:IHC3+GastricCarcinoma
90%ofkilling
99.9%ofkilling
FasterandmorecompletekillingoftumorcellsbyGBR1302comparedtocurrent1st and
2nd linetreatments
31
GBR1342(MultipleMyeloma)
ComparisonagainstDaratumumab
GBR1342targetsCD38;beingdevelopedformultiplemyelomaandpotentiallyother
malignanciesofhematopoieticorigin
ActivityofGBR1342vs.DaratumumabonpatientderivedMMcelllines
RPMI8226
IM9
Inpreclinicalassays,GBR1342ismorepotentandefficaciousthanDaratumumab
CellLine:RPMI8226 PlasmacytomaMyeloma,IM9 MultipleMyeloma
32
GBR1342(MultipleMyeloma)
Invivoefficacyintherapeutictreatmentmodel
Antibodyinjection(IV)
InitiatedonDay7
Dauditumor+hPBMC
Dau_14Study,XenograftSC(mean+/ SEM)
ImmunodeficientMice
XenograftinSC
2PBMCdonors
E:TRatio 2:1
GBR1342isefficaciousinvivoinatherapeutictreatmentmodel
33
GBR1372(ColorectalCancer)
InvivoefficacyagainstKRASmutation
GBR1372bypassesKRASandBRAFmutationlimitationsofcurrenttherapies;beingdeveloped
forcolorectalcancers,NSCLCandHead&NeckcancersrefractorytoErbitux/Vectibix
A549_7Study XenograftSC(Mean+/ SD)
A549_7Study XenograftSC,Day19
GoodefficacyinA549tumors:SuperiorityoverVectibixonKRASmutatedtumorcellline
Note:A549_7 KRASmutatedlungcarcinoma
34
GBR8383(MultipleCancers)
Apotentcheckpointinhibitor
GBR8383isanewtypeofhighlypotentOX40agonist;newmechanismof
action bydesignandbasedonconfirmedstructuraldata
Preclinicaldataconfirmsastrongagonisticeffectuponthecheckpoint
regulatorOX40incomparisontootherOX40agonists,currentlyinclinic
Potentialtobethefirstinanewclassofagoniststargetingamemberof
theTNFRsuperfamily
Note:OX40isapositivecheckpointregulatorandmemberoftheTNFreceptorsuperfamily(like41BBandothers)
35
GBR8383:PotentialtoenhanceCD3mediatedkilling
Upsidepotentialincombinationimmunotherapy
Inhousemodels(tumorxenograft)Dau_11
Antibodyinjection(IV)
Dauditumor+
hPBMC
NOD
SCID
ImmunodeficientMice
XenograftinSC
GBR8383canenhanceantitumoreffectofGBR1342*invivo
Note:*GBR1342usedinsuboptimaldoses
36
GBR8383versusCheckpointCombinations
CompetitiveprofileversusNivolumabandcombinations
Assay:proliferationofTCellsinresponsetoGBR8383,comparedtoNivolumabandvarious
combinationsofNivolumab(inBEATformat)
TCellProliferationindexnormalizedtoNivolumab
Nivolumab
GBR8383haspotentialtoenhancecurrentimmunotherapies(PD1,PD1L,CTLA4).
Upside:similarmechanismsmaybeappliedtoothermembersoftheTNFRsuperfamily
Note:BEAT1to4areNivolumabcombinations(inBEATformat)withCD27,LAG3,VISTAand41BB
37
Oncology:Significantunmetmedicalneedsacross
indicationsbeingpursued
Resistantmetastaticbreastcancer(mBC)
GBR1302
Breast* and
GastricCancer
Primaryresistancetotrastuzumab~6070%15
~70%ofpatientsacquiredresistancetotrastuzumabwithin1yearoftreatment15
LackofadequatetreatmentoptionsforHER2equivocalmBC
GastricCancer
2nd leadingcauseofcancerrelatedmortalityworldwide.Only2targeted
therapies trastuzumabandramucirumab
GBR1342
NewtreatmentshaveimprovedthesurvivalratebutMMstillnotcurable
Multiple
Myeloma
CurrenttreatmentregimesnoteffectiveinaggressivecasesofMM
GBR1372
3rd mostcommoncancerwithstageIVincidencerateof~20%
Substantialchallengetomanagetoxicityduetoagedpatientpopulation
~60%ofpatientsprogressto2Landover30%progressto3Ltreatmentoptions
Colorectal
Cancer
Lackofefficacious& safetreatmentoptions,esp.RASmutantandrefractorypatients
CetuximabandpanitumumabapprovedonlyinKRASWT
Note:*Resistantmetastaticbreastcancer,HER2equivocalmetastaticBreastCancer
1.WongAL,etal.IntJBreastCancer.2012;2012:415170;2.ArribasJ,etal.CancerRes.2011;71(5):15151519;3.SpectorNL,etal.JClinOncol.2009;27(34):58385847;4.PohlmannPR,etal.ClinCancerRes.
2009;15(24):74797491;5.VuT,etal.FrontOncol.2012;2:62
38
GBR1302:Overviewofclinicaldevelopmentplan
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Monotherapy
Phase1Part
1 Dose
Escalation
Doseescalation
studyinHER2+
subjects
MTDandSafety
Phase1Part
2
Expansion
Cohortexpansionfor
HER2+resistantmBC,
HER2equivocalmBC
andotherHER2+or
equivocalmetastatic
tumorsinc. GI
DCR,Safetyand
Tolerability
EOP2
Phase2
Monotherapy
BLA
Phase3
Monotherapy
Combination
Phase1
Combo
Phase2
Combination
EOP2
Phase3
Combination
Phase1Part2resultstodetermineprogressiontomonotherapyorcombination
BLA
39
GBR1342:Overviewofclinicaldevelopmentplan
Phase2/3
Monotherapy
DoseEscalation
Phase1,Part1
Pretreatedpatients
1342Monotherapy
DoseEsctoMTD
N~30
ProofofConcept
Phase1,Part2
Pretreatedpatients
1342Monotherapy
N=65
ORRData
Phase2
Mono
Phase3
Mono
Phase2
Combo
Phase3
Combo
LevelofOverallResponseRateinPhase1todeterminephase2/3clinicalplan
40
Assetsindevelopment:Dermatology
Therapy
Molecule
MoA/Class
Indication
Oncology
GBR1302
HER2XCD3
BreastCancer
GastricCancer
Oncology
GBR1342
CD38XCD3
MultipleMyeloma
Oncology
GBR1372
EGFRXCD3
ColorectalCancer
Oncology
GBR8383
OX40RAgonist
MultipleCancers
Dermatology GBR830
OX40Antagonist AtopicDermatitis
Respiratory
GRC388XX
Undisclosed
COPD,IPF
Respiratory
GSP301
Steroid+AH
AllergicRhinitis
Respiratory
GSP304
LAMA
Respiratory
GBR310
Biosimilar
Asthma,CIU
Pain
GRC27864
mPGES1
ChronicPain
COPD
Pre
Clinical
Phase1
Phase2
Phase3 Approval
41
GBR830:CurrentlyinPhase2foratopicdermatitis
FirstinclassOX40antagonisttargetingactivatedTcellsandeffectormemoryTcells
CurrentlyinPhase2formoderatetosevereatopicdermatitis
Otherautoimmunedisordersalsounderconsideration
SingleAscendingDose(SAD)StudyinHealthyVolunteers
Outcomes
Phase1
Safeandwelltoleratedin34healthyadultsvs.18onplacebo
Noclinicallysignificantfindingsw.r.t.laboratorytestresults,vitalsigns,
ECG,cytokinesinserum
DoseproportionalPKprofilewitht1/2 between10and15days
ProofofConceptstudyongoinginUSAandCanadainadultssufferingfrom
moderatetosevereAD
Phase2
PrimaryEndpoints
Safetyandtolerability
Biologicalresponseinskinbiopsies
42
AssetsinDevelopment:Respiratory
Therapy
Molecule
MoA/Class
Indication
Oncology
GBR1302
HER2XCD3
BreastCancer
GastricCancer
Oncology
GBR1342
CD38XCD3
MultipleMyeloma
Oncology
GBR1372
EGFRXCD3
ColorectalCancer
Oncology
GBR8383
OX40RAgonist
MultipleCancers
Dermatology GBR830
OX40Antagonist AtopicDermatitis
Respiratory
GRC388XX
Undisclosed
COPD,IPF
Respiratory
GSP301
Steroid+AH
AllergicRhinitis
Respiratory
GSP304
LAMA
Respiratory
GBR310
Biosimilar
Asthma,CIU
Pain
GRC27864
mPGES1
ChronicPain
COPD
Pre
Clinical
Phase1
Phase2
Phase3 Approval
43
Respiratory:Presenceacrossthediseaseanddevice
spectrum
Respiratorypipelinecoverskeydiseaseareasandhaveproductsonvariousdeviceplatforms
MDI,DPI,Injectables,NebulizersandNasalSprays
DiseaseSegments
DevicePlatforms
Note:Imagesareforrepresentationpurposeonly
Asthma
MDI
DPI
COPD
Injectable
AllergicRhinitis
Nebuliser
NasalSprays
44
Respiratory:PipelinefortheUSmarket
Respiratorypipelinehas3Specialtyand3Genericassetsindevelopment.Inaddition,NCE
programisinlatediscoveryphasetargetingsignificantunmetmedicalneeds
Type
MoA/Class
Indication
CurrentStatus
ExpectedFiling
Novel
Undisclosed
COPD,IPF
PreClinical
TBD
GSP301
Specialty
Steroid+AH
AllergicRhinitis
Phase3
Q2CY19
GSP304
Specialty
LAMA
COPD
Phase2
Q4CY19
GBR310
Specialty
Biosimilar
Asthma,CIU
PreClinical
Q4CY20
GSP101
Generic
ICS+LABA
Asthma,COPD
Q3CY18
GSP103
Generic
ICS
Asthma
Q4CY18
GSP104
Generic
ICS+LABA
Asthma
Q2CY19
Molecule
GRC388XX
TargetingtolaunchspecialtyproductsintheUSinnext34yearsalongwithgenerics
45
Expectedtofile9NDA/BLAinthenextdecadeacross
NMEandSpecialtyportfolio
TherapyArea
Molecule
FilingTimelines(NDA/BLA)
Status
2019
GSP301
Phase3
GSP304
Phase2
GBR310
PreClinical
GRC388XX
PreClinical
Respiratory
2020
2021
2022
2023andBeyond
Phase2
GBR1302
Phase1
GBR1342
PreClinical
GBR1372
PreClinical
GBR8383
PreClinical
Dermatology GBR830
Oncology
Note:Abovetimelinesarebasedoncurrentlyplannedstudies.Theymaychangebasedupondata,regulatoryagenciesfeedbacketc.
46
Agenda
Journeyoverthelast15years
StrategicRoadmap
GlobalGenericsBusiness
ResearchandDevelopment
OverviewofKeyAssets
Financials
Summary
47
Robustfinancialperformanceinthelastfiveyears
Revenues(INRmn)
40,299
FY12
50,188
FY13
60,100
FY14
66,502
FY15
Adj.EBITDAMargin
76,620
FY16
22.5%
20.9%
FY12
GrossDebt/Equity
0.9
FY12
FY13
FY13
1.1
2.1
2.1
FY12
FY13
0.9
FY14
FY15
FY14
20.4%
20.6%
FY15
FY16
NetDebt/EBITDA
1.3
1.0
22.0%
FY16
AdjustedEBITDAcalculatedafterremovingoneoffexpensesandFXloss/gain
2.2
1.9
FY14
FY15
2.0
FY16
48
Financialoutlookforthenext45years
RevenuestogrowataCAGRof1520%overthenext5years
India,US,EUandAPItocontribute>80%totheoverallrevenues
Growthand
Profitability
Operatingmargintobeat2223% fromFY18onwards.Highermargin
inFY17onaccountofgZetialaunch
R&Dexpense,netofoutlicensingincome,tobe~11%ofrevenues
Corporatetaxratetobe~25%goingforward
CapitalexpenditureofINR600700cr. onfixedassetsannually
Annualspend on Intangibleassets tobeINR200cr.onaccountofin
licensingofcomplexgenerics
Investmentsand
FinancialStatus
NetDebttoEBITDAratiotoprogressivelygodownfromhereon
Mar17netdebttobelowerthanMar16levels
NetWorkingcapitaltobe~110days (ofsales)
ROCE tobe1820% overthenext45years
49
Agenda
Journeyoverthelast15years
StrategicRoadmap
GlobalGenericsBusiness
ResearchandDevelopment
OverviewofKeyAssets
Financials
Summary
50
Summary
Glenmarkin2016
2majorgeographies
USandIndia
Revenuestream
consistingofpurely
genericsportfolio
US,EUbusinessbased
onsubstitutionmodel
NMEpipelineinearlyto
midstages
Manufacturingbase
primarilyinIndia
Profitabilitymarginat
~20%
Glenmarkin2020
US,India,Europeand
APItocontribute>80%
ofsales
Increasedpresencein
complexgenerics
Launchofspecialty
businessintheUS
NMEpipelinein
advancedstageof
development
Glenmarkin2025
Launchofinnovative
products
Specialtybusinessramp
upintheUS
SpecialtyandInnovative
segmentstobethe
maingrowthdrivers
Increasedpresencein
complexgenericsspace
Globalmanufacturing
footprint
~30%oftotalrevenues
fromspecialtyand
innovationsegments
Profitabilitymarginat
~23%
Profitabilitymarginat
~25%
51
ThankYou