Sie sind auf Seite 1von 52

StrategicBlueprintfortheNextDecade

19th December,2016

Disclaimer
These materials have been prepared by Glenmark Pharmaceuticals (Glenmark or the Company) solely for informational purposes, and are
strictly confidential and may not be taken away, reproduced or redistributed to any other person. By attending this presentation, participants
agree not to remove this document from the conference room where such documents are provided without express written consent from the
Company. Participants agree further not to photograph, copy or otherwise reproduce these materials at any point of time during the
presentation or while in your possession. By attending this presentation, you are agreeing to be bound by the foregoing restrictions. Any failure
to comply with these restrictions may result in a violation of applicable laws and commencement of legal proceedings against you

It is not the Companys intention to provide, and you may not rely on these materials as providing, a complete or comprehensive analysis of the
Companys financial position or prospects. The information contained in these materials has not been independently verified and is subject to
verification, completion and change without notice. The information contained in these materials is current as of the date hereof and is subject
to change without notice, and its accuracy is not guaranteed. The Company is not under any obligation to update or keep current the
information contained in these materials subsequent to the date hereof. Accordingly, no representation or warranty, express or implied, is made
or given by or on behalf of the Company, or any of its directors and affiliates or any other person, as to, and no reliance should be placed for any
purposes whatsoever on, the fairness, accuracy, completeness or correctness of, or any errors or omissions in, the information contained in
these materials. Neither the Company, its directors, officers or employees nor any other person accept any liability whatsoever for any loss
howsoever arising from any use of these materials or their contents or otherwise arising in connection therewith

These materials contain historical information of the Company which should not be regarded as an indication of future performance or results.
These materials may also contain forwardlooking statements that are, by their nature, subject to significant risks and uncertainties. These
forwardlooking statements reflect the Companys current views with respect to future events and are not a guarantee of future performance or
results. Actual results, performance or achievements of the Company may differ materially from any future results, performance or
achievements expressed or implied by such forwardlooking statements. Such forwardlooking statements are based on numerous assumptions
regarding the Companys present and future business strategies and the environment in which the Company will operate in the future, and must
be read together with such assumptions. Predictions, projections or forecasts of the economy or economic trends of the markets are not
necessarily indicative of the future or likely performance of the Company, and the forecast financial performance of the Company is not
guaranteed. No reliance should be placed on these forwardlooking statements, if any.

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

Note:RevenuesforFY2000andFY2016.MarketCapitalizationisasof31st March2000and16th Dec2016.FXRate:US$1=INR67

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

Specific killing (%)

100

Specific killing (%)

% specific killing

100

50

-50

Log antibody concentration

Log antibody concentration

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

Das könnte Ihnen auch gefallen