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Our Vision

To emerge as a
leading, researchbased,
global,
integrated
pharmaceutical
company

Our Values

Safe Harbour Statement


This presentation has been prepared by Glenmark.
The information, statements and analysis made in this presentation
describing companys objectives, projections and estimates are forward
looking statements and progressive within the meaning of applicable
security Laws and Regulations.
The analysis contained herein is based on numerous assumptions.
Actual result may vary from those expressed or implied depending upon
economic conditions, government policies and other incidental factors.
No representation or warranty, either expressed or implied, is provided
in relation to this presentation. This presentation should not be regarded
by recipients as a substitute for the exercise of their own judgment.

Agenda
Glenmark
Glenmark Pharmaceuticals Limited (GPL) Specialty
Business

Glenmark Generics Limited (GGL- wholly owned sub. of


GPL) Generics Business

Glenmark Consolidated Financials and Projections

Glenmark
Glenmark has made rapid strides towards achievement of vision
Research efforts in Small
molecules, Biologics and Generics

Research
based

Pre 2000 Glenmark


Sales< $ 20 mn
Domestic focus
<5% of exports

13 new molecules under


development
Over $ 110 mn of cash received
from out-licensing partners;
Further milestones worth over $
600 mn
Over 5000 employees across
5 continents

Global

Mfg facilities in 4 countries


Operates in over 85 countries

Glenmark today
Revenues : $ 499 mn
India based MNC
>60% of exports

Front ends in US, India, Brazil


and other markets worldwide

3 API plants

Integrated

8 finished dosage plants


3 research facilities

Glenmark - Global Footprint


Glenmark Generics
Europe Limited,
London, UK

Medicamenta,
Czech Republic

1 Dosage Plant,
HP, India
1 API Plant,
Gujarat, India

1 Dosage
Plant
Czech Republic

1 Dosage Plant,
Maharashtra, India

Glenmark
Generics Ltd., US
Glenmark
India

1 Dosage
Plant - Brazil

Glenmark Pharma
Europe Limited,
London, UK

Glenmark
Generics SA,
Argentina

3 Dosage Plants,
Goa, India

Bowter Bartlett
South Arica

R&D for NCEs,


India

R&D for Generics,


India
1 Dosage
Plant - Argentina

Glenmark
Farmacetica Ltda.,
Brazil

R&D for Biologics,


Switzerland

2 API Plants,
Maharashtra,India

Several other subsidiaries and representative offices exist across the world

Glenmark - Financials
FY 20071

(ending Mar07)

FY 20082

(ending Mar08)

Change

Audited

Un-audited

(in %)

Operating income (A)

283.54

499.18

76%

Expenditure (B)

186.96

299.80

60%

% EBITDA (Operations) [C =(A-B)/A]

34%

40%

EBT (Operations) (D)

78.30

165.79

112%

Other Income (E)

3.56

11.06

211%

PBT (F=D+E)

81.86

176.85

116%

PAT (G)

70.25

156.72

123%

Basic Earnings per share (in rupees)

12.99

25.81

In $ mn

Note :
1.
Average conversion rate for FY 2006-07 of Rs. 44.14 / USD 1.00
2.
Average conversion rate for FY 2007-08 of Rs. 40.28 / USD 1.00
6

Glenmark
Glenmark has shown consistent robust growth across businesses

ending Mar06

ending Mar07

Note :
1.
2.
3.

ending Mar08

Revenues in $ mn

Average conversion rate for FY 2005-06 of Rs. 44.28 / USD 1.00


Average conversion rate for FY 2006-07 of Rs. 44.14 / USD 1.00
Average conversion rate for FY 2007-08 of Rs. 40.28 / USD 1.00
7

Glenmark

Glenmark is divided into two main businesses with different business focu
Specialty/Proprietary

Glenmark
Pharmaceuticals Ltd
(GPL)

Generics

Wholly
owned
subsidiary

Glenmark
Generics Ltd
(GGL)

Leadership

Glenn Saldanha

Chairman:
Glenn Saldanha
CEO:
Terry Coughlin

Vision

Global end to end Specialty Company

Global integrated Generic & API leader

MD and CEO:

*To be listed in India during FY 2009


8

Agenda
Glenmark
Glenmark Pharmaceuticals Limited (GPL) Specialty
Business

Glenmark Generics Limited (GGL- wholly owned sub. of


GPL) Generics Business

Glenmark Consolidated Financials and Projections

Vision for Glenmark Pharmaceuticals Limited


Global end-to-end Specialty Company

Product Portfolio
Launch two proprietary drugs
Build late stage pipeline

Market Presence
Target 2015

Proprietary product front ends in US, key ROW &


European markets

Market Positioning
Innovation led company
Differentiated branded generic company

Strate
gy
Licensing
Build differentiated
product franchise

Invest in building
brands
Expand into new
territories

Transition into a
proprietary
product marketing
company
10

Glenmark Pharmaceuticals Limited: Specialty Business


Global Therapeutic Focus
Inflammation

Innovative R&D
Therapeutic Focus

Pain, Respiratory
(Asthma/COPD),
Rheumatoid Arthritis

Metabolic Disorders

Diabetes (Type II),


Obesity

Dermatology

Psoriasis, Pruritus,
Atopic Dermatitis

11

Glenmark Pharmaceuticals Limited: Specialty Business


Business Unit Structure
Glenmark Pharmaceuticals Ltd. (GPL)

R&D

NCE

Finished Dosage Formulations

Biologics
(Swiss)

ROW
(Rest of the
World)

Europe

US
(Inorganic
entry)

12

Research and Development (R&D)

Glenmark Pharmaceuticals Limited: Specialty Business


Glenmarks R&D Efforts both small molecules and biologics
New Chemical Entity (NCE)
Research

New Biological Entity (NBE)


Research

Over 300 scientists

Over 55 scientists

Based in Mumbai, India

Based in Switzerland

Pipeline of 13 molecules
8 NCEs and 5 NBEs

14

Glenmark Pharmaceuticals Limited: Specialty Business


Research Pipeline: 13 molecules at various stages of development

Screening

World
class
targets

DPP-IV, PDE IV, CB2, TRPV1, SCD1, VLA2, TRPV3 etc.

Discovery

13
research
molecules

One undisclosed
NCE
Three undisclosed
NBEs

Pre-clinical
GRC 10693

Phase I
GRC 4039

GRC 9332

Phase IIb
Oglemilast (1)
Melogliptin (2)

GBR 500 *

GRC 6211 (3)

GBR 600 *
GRC 17173

* NBE

(1)

Out-licensed to Forest Labs and Tejin Pharma

(2)

Out-licensed to Merck KGaA All rights received back

(3)

Out-licensed to Eli Lilly & Co.


15

Glenmark Pharmaceuticals Limited: Specialty Business


Progress on Research Pipeline
Compound

Primary Indications

Target

Target
Launch

GRC 3886
(Oglemilast)

Asthma, COPD

PDE IV

2011

GRC 6211

Osteoarthritis, Neuropathic
Pain, Dental Pain,
Incontinence

TRPV1

2012

GRC 8200
(Melogliptin)

Diabetes (Type II)

DPP IV

2012

GRC 4039

Rheumatoid Arthritis,
Inflammation, Multiple
Sclerosis

PDE IV
+ TNF-
+ T-cell

2012

GRC 10693

Neuropathic Pain,
Osteoarthritis and other
Inflammatory Pain

CB 2

2013

GRC 9332

Obesity, Dyslipidemia,
Metabolic Disorders

SCD 1

2013

GRC 17173

Osteoarthritis, Neuropathic
Pain, Dental Pain

TRPV3

2013

GBR 500

Acute Multiple Sclerosis,


Inflammatory Disorders

VLA2

2013

GBR 600

Acute Stroke/ Coronary


Syndrome, Thrombosis
Cardiovascular Disorders

undiscl
osed

2014

Preclinicals

Phase I

Phase II

Phase III

Approva
l

One NCE and three biologics are at the discovery stage and are expected to enter the clinics during FY 2010/2011
16

Glenmark Pharmaceuticals Limited: Specialty Business


Oglemilast [Target: PhosphoDiesterase (PDE) IV Inhibitor]
Indications

Asthma, COPD (Chronic Obstructive Pulmonary Disease)

Opportunity

High level of unmet need


Lack of novel validated targets: Dominated by reformulations and me-too
products

Competing Compounds

Compound under development following same mechanism is Roflumilast


(Altana - Ph III)

Status

Ph IIb for COPD initiated in US; Ph IIb for asthma will be initiated by Sep 2008
Out-licensed North American rights to Forest Labs. Total deal size is $ 190
mn. Already received total $ 35 mn as upfront and milestones. Glenmark will
also receive royalties upon launch
Out-licensed Japanese rights to Teijin Pharma. Total deal size is $ 53 mn.
Received $ 6 mn as upfront payment. Glenmark will also receive royalties
upon launch

Key Differentiators

Oral, once daily regimen


No emesis and nausea observed in the clinics
Large therapeutic window to escalate doses (as compared to other PDE IVs)

Targeted
population/Market Size

Asthma patients: 45 mn worldwide


COPD patients: 30 mn worldwide (with only 6 mn receiving treatment)
COPD/Asthma market : $ 28.7 bn worldwide

Potential Peak Sales

>$ 3 bn worldwide

Target Launch

2011
17

Glenmark Pharmaceuticals Limited: Specialty Business


GRC 6211 [Target: Transient Receptor Potential Vanilloid (TRPV)1 Antagonist]
Indication

Osteoarthritis, Neuropathic Pain, Dental Pain, Incontinence

Opportunity

Large unmet medical need


Recent concerns around safety of Cox-2 inhibitors will propel sales of safer
products

Competing Compounds

MK-2295 (Merck & Co. - Ph II) and SB 705498 (GSK - Ph II) are two competing
compounds under development following same mechanism

Status

Ph IIb ongoing
Out-licensed to Eli Lilly & Co. for developing and marketing for North
America, Europe and Japan for various pain indications, including
osteoarthritis. Total deal size is $ 350 mn. Received upfront payment of $ 45
mn. Glenmark has rights for co-promotion in the US and will also receive
royalties upon launch

Key Differentiators

Potential first in class opportunity

Targeted population/Market
Size

Osteoarthritis Market: $ 4 bn; >20 mn patients


Neuropathic Pain Market: $ 5 bn; >40 mn patients

Potential Peak Sales

>$ 3 bn worldwide

Target Launch

2012
18

Glenmark Pharmaceuticals Limited: Specialty Business


Melogliptin [Target: Dipeptidyl Peptidase (DPP) IV Inhibitor]
Indications

Diabetes (Type II)

Opportunity

Large, undiagnosed and increasing patient population


Less than 50% of diabetics treated successfully, therefore excellent prospects for products
with a strong safety and efficacy profile
Recently observed safety issues related to Glitazones

Competing
Compounds

Januvia (Merck & co. - Sitagliptin), the first in class compound was launched in Oct06;
JanuMet (Sitagliptin + Metformin) launched in Apr 07. Sales tracking of Januvia franchise
> $ 1bn
Galvus (Novartis - vildagliptin) launched in Brazil & Mexico. Galvus & Eucreas
(vildagliptin + metformin) approved in EU

Status

Ph IIb ongoing; expected to enter Ph III by Oct 2009


Expect to be 4th or 5th in the market with differentiating features
Out-licensed molecule to Merck KGaA for a total deal size of $ 250 mn. Due to portfolio
restructuring at Merck KGaA, Glenmark received all rights back for further development and
commercialization. Glenmark had received $ 31 mn as upfront payment from Merck KGaA
earlier
Currently under discussions for licensing with potential partners

Key Differentiators

Good specificity over DPP VIII and DPP IX


Better side effect profile as compared to similar compounds

Targeted
population/Market
Size

125 mn patients worldwide


Market Size: $ 13 bn worldwide

Potential Peak Sales

>$1 bn worldwide

Target Launch

2012
19

Glenmark Pharmaceuticals Limited: Specialty Business


GRC 4039
Target: (a) PhosphoDiesterase (PDE) IV Inhibitor
(b) TNF Alpha Inhibitor
(c) T-Cell Cytokine Inhibitor
Indication

Rheumatoid Arthritis (RA), Inflammation, Multiple Sclerosis

Opportunity

Void exists in RA therapy for orally available potent small molecules


35% of RA patients remain untreated
Biological treatments currently available are expensive

Competing Compounds

Biological (e.g. anti-TNF) and small molecules

Status

Ph I ongoing;

Key Differentiators

Excellent efficacy in animal models in RA


Good safety profile to achieve higher exposure levels in humans
Good bioavailability across species and a long half-life indicating the
potential for a once-daily dosing regimen

Targeted
population/Market Size

Rheumatoid Arthritis Market: $16 bn; > 20 mn patients

Potential Peak Sales

>$3 bn worldwide

Target Launch

2012

20

Glenmark Pharmaceuticals Limited: Specialty Business


GRC 10693 [Target: Cannabinoid-2 (CB-2) Receptor Agonist]
Indication

Neuropathic Pain, Osteoarthritis and other Inflammatory Pain

Opportunity

Large unmet medical need


Recent concerns around safety of Cox-2 inhibitors will propel sales of
safer products

Competing Compounds

GW-842166X (GSK - Ph II) & A-796260 (Abbott Discovery) follow


similar mechanism

Status

Pre-clinical development; expected to enter the clinics in Q1 FY 2009

Key Differentiators

Potential early launcher in this class

Targeted
population/Market Size

Neuropathic Pain Market: $ 5 bn; >40mn patients


Osteoarthritis Market: $ 4 bn; >20 mn patients

Potential Peak Sales

>$2 bn worldwide

Target Launch

2013

21

Glenmark Pharmaceuticals Limited: Specialty Business


GRC 9332 [Target: Stearoyl CoA Desaturase-1(SCD1) Inhibitor]
Indication

Obesity; Dyslipidemia; Metabolic Disorders

Opportunity

Current approved products characterized by modest efficacies and


problematic safety and tolerability profiles
Large unmet medical need with growing patient population globally
on account of changing lifestyles

Competing Compounds

Ph-I program at Isis/Merck & Co.; Discovery program at Xenon/


Novartis

Status

Pre-clinical development; expected to enter clinics by Q3 FY09

Key Differentiators

Potential first in class; early mover advantage

Targeted
population/Market Size

More than 160 mn people estimated to be Obese in major markets


worldwide only 6 mn are treated therapeutically
Current Market : $ 2 bn

Potential Peak Sales

>$1bn worldwide

Target Launch

2013
22

Glenmark Pharmaceuticals Limited: Specialty Business


GRC 17173 [Target: Transient Receptor Potential Vanilloid (TRPV)3 Antagonist]
Indications

Neuropathic Pain, Osteoarthritis, Dental Pain

Opportunity

Recent concerns around safety of Cox-2 inhibitors will propel sales of safer
products
Large unmet medical need

Competing Compounds

In July 2007, Pfizer acquired a series of TRPV3 antagonists for pain from Hydra
Biosciences for total milestone payments of $ 190 mn and royalties on launch

Status

Pre-clinical development; expected to enter clinics by Q3 FY 09

Key Differentiators

Potential first in class opportunity

Targeted
population/Market Size

Osteoarthritis Market: $ 4 bn; >20 mn patients


Neuropathic Pain Market: $ 5 bn; >40mn patients

Potential Peak Sales

>$ 3 bn Worldwide

Target Launch

2013

23

Glenmark Pharmaceuticals Limited: Specialty Business


GBR 500
Target: (a) Alpha2 eta1 Integrin Antagonist
(b) Very Late Antigen
(VLA2)2
Indication
MS (Multiple
Sclerosis), IBD (Inflammatory Bowel Disease)
Opportunity

Inhibits a variety of cell types (neutrophils, etc) associated with different forms
of inflammation hence should work in a variety of inflammatory diseases

Competing
Compounds

Novel in class with same indications

Status

IND preparation; expected to enter clinics by Q2 FY 09

Key Differentiators

Potential first in class with the target


Offers significant differentiation potential with potentially superior efficacy to
competing products

Targeted
population/Market
Size

MS Market : $ 3 bn;
IBD biologics Market: $ 5 bn; > 4 mn patients

Potential Peak Sales

> $ 1 bn

Target Launch

2013

24

Glenmark Pharmaceuticals Limited: Specialty Business


GBR 600 [Target: Undisclosed]
Indication

Acute stroke / Coronary Syndrome; Thrombosis Cardiovascular


Disorders

Opportunity

The high incidence of bleeding with the marketed products remains the
greatest challenge in disease treatment
Clinical efficacy has been modest with current agents

Competing
Compounds

Marketed drugs for PCI (Percutaneous Coronary Indications) indications


include Plavix(Sanofi-Aventis), ReoPro (Eli Lilly) and Integrilin
(Schering Plough)

Status

Pre-clinical development; expected to enter the clinics by Q4 FY 09

Key Differentiators

Low incidence of bleeding, thus allowing wider use of GBR-600


Large therapeutic window between efficacy dose and bleeding dose
Novel mechanism for current targeted indications

Targeted
population / Market
Size

Current Market : $2 bn
GBR-600 has the potential to significantly expand the current market by
offering improved efficacy with favorable adverse event profile

Potential Peak Sales

> $ 1 bn

Target Launch

2014
25

GPL- Specialty Business


RoW, Europe and US

ROW

India
(2000*)

Europe
(80*)

Latin America
(200*)

Asia
(200*)

US
(inorganic
route)

Africa
(160*)

CIS
(300*)

*Sales force strength

Glenmark Pharmaceuticals Limited: Specialty Business


Glenmarks strategy for future growth in RoW markets
Focus
Focuson
onTop-15
Top-15markets
markets
High
Highthrust
thruston
onbuilding
buildingbranded
brandedbusiness
business
which
currently
accounts
for
over
which currently accounts for over 85%
85%
Launch
Launchofofnovel
noveldifferentiated
differentiatedbranded
branded
generics
for
getting
a
significant
competitive
generics for getting a significant competitive
edge
edge

Asia
India
Africa
Latin
America

Australia

Strategy

CIS

Capitalize
Capitalizeon
onlocal
localknow-how
know-how(country
(country
heads
in
over
20
markets)
heads in over 20 markets)
Driving
Drivingthe
thebusiness
businessthrough
throughqualified,
qualified,
experienced
and
dedicated
field
experienced and dedicated fieldforce
force
Focus
Focuson
onsustainable
sustainabledoctor
doctorcentric
centric
prescription
based
model
for
prescription based model forbuilding
building
brands
brands
Leverage
Leverageon
onefficient
efficientand
andquality
quality
distribution
network
for
better
distribution network for bettermarket
market
penetration
penetration

27

RoW Markets
India

Glenmark Pharmaceuticals Limited: Specialty Business


India Performance FY 2008

Revenues in $ mn

ending Mar07

ending Mar08

ending Mar09

ending Mar10

Highlights

Glenmark registered a growth of 21% higher than the Indian pharma market growth at 15% (ORG
Feb 2008)

Currently commands 1.36% market share up from 1.29% in FY 2007 (ORG Feb 2008)

Currently ranked 24th in the highly fragmented Indian pharma market

Top-10 brands contribute over 60% of India business

* Projected

29

Glenmark Pharmaceuticals Limited: Specialty Business


India Action Plan

Glenmarks
presence

Operates through 9 divisions


Sales force > 2000 medical representatives
Markets over 250 products in India

Register growth of over 10 %


Action Plan
FY 2009

Launch > 20 new products


Maintain leadership in dermatology and consolidate position
in other therapies

RoW Markets
Latin America (LatAm)
Brazil
Venezuela
Mexico
Peru
Chile
Bolivia
Columbia
Ecuador
Caribbean countries

Glenmark Pharmaceuticals Limited: Specialty Business


LatAm Performance FY 2008

Revenues in $ mn

ending Mar07

ending Mar08

ending Mar09

ending Mar10

Highlights

* Projected

Registered growth of over 65%

Launched 25 products across LatAm

Filed for over 100 product approvals in FY 2008

Top-10 brands contribute over 75% of LatAm business

32

Glenmark Pharmaceuticals Limited: Specialty Business


LatAm Action Plan
LatAm Pharma Market : >$ 35 bn
Glenmarks
Presence

Brazil, Mexico, Argentina, Venezuela are the key markets


Registered over 250 products in the LatAm markets
Strong sales force setup of 200 medical representatives
Register growth of over 25 %

Action Plan
FY 2009

File for 80 product approvals and launch 60 products


Plans to enter Mexico during FY 2009
Revenue contribution *
FY 2009
(ending Mar09)

* Projected

FY 2010
(ending Mar10)

33

RoW Markets
Australasia
CIS & Japan)
Malaysia
Philippines
Indonesia
China
South Korea
Myanmar
Vietnam
Sri Lanka
Cambodia
Australia

(excluding India,

Glenmark Pharmaceuticals Limited: Specialty Business


Australasia Performance FY 2008

Revenues in $ mn

ending Mar08

ending Mar09

ending Mar10

Highlights

Launched over 60 products

Filed for over 100 product approvals

Top-10 brands contribute over 65% of the business

* Projected

35

Glenmark Pharmaceuticals Limited: Specialty Business


Australasia Action Plan
Australasia Pharma Market (excluding India, Japan, CIS) : >$ 55 bn
China, Philippines, Malaysia, Indonesia, Australia are the key markets
Glenmarks
Presence

Registered over 400 branded generic products across Asian markets


Recently entered Australia, China and Indonesia
Strong sales force setup of 200 medical representatives

Action Plan
FY 2009

Register growth of over 20 %


File for 100 product approvals and launch 30 products
Revenue contribution *
FY 2009
(ending Mar09)

* Projected

FY 2010
(ending Mar10)

36

RoW Markets
Africa
South Africa
Nigeria
Kenya
Sudan
Egypt
Tanzania
Yemen
Ivory Coast
Zambia
Mauritius
Uganda
Cameroon
Ghana

Glenmark Pharmaceuticals Limited: Specialty Business


Africa Performance FY 2008

Revenues in $ mn

ending Mar08

ending Mar09

ending Mar10

Highlights

Launched 80 products across Africa

Filed for over 150 product approvals across Africa

Top-10 brands contribute over 85% of Africa business

Glenmark marked its entry into Egypt by establishing an office

* Projected

38

Glenmark Pharmaceuticals Limited: Specialty Business


Africa Action Plan
Africa Pharma Market : >$ 10 bn
South Africa, Nigeria, Sudan, Kenya, Egypt are key markets

Glenmarks
Presence

Register over 600 branded generic products


Marketing products in over 30 countries; Direct presence in 10 countries
160 sales representatives across Africa
Register growth of over 35 %

Action Plan
FY 2009

File for 75 products and launch 45 products


Plans to enter Algeria, UAE
Look for brand acquisition opportunities for entry/growth
Revenue contribution *
FY 2009
(ending Mar09)

* Projected

FY 2010
(ending Mar10)

39

RoW Markets
CIS
Russia
Ukraine
Uzbekistan
Kazakhstan

Glenmark Pharmaceuticals Limited: Specialty Business


CIS Performance FY 2008

Revenues in $ mn

ending Mar08

ending Mar09

ending Mar10

Highlights

Company launched 40 products

Filed for over 30 product approvals across CIS

Top-5 brands contribute over 90% of CIS business

Glenmarks brand Ascoril is the no 1 brand in the cough expectorant market in Russia

* Projected

41

Glenmark Pharmaceuticals Limited: Specialty Business


CIS Action Plan
CIS Pharma Market : >$ 15 bn

Glenmarks
Presence

Russia, Ukraine, Uzbekistan & Kazakhstan are the key markets


Registered over 70 branded generic products
300 medical representatives cover entire CIS
Register growth of over 70 %

Action Plan
FY 2009

File for 25 product approvals


Launch 25 products
Revenue contribution *
FY 2009
(ending Mar09)

* Projected

FY 2010
(ending Mar10)

42

Europe

Glenmark Pharmaceuticals Limited: Specialty Business


Europe Performance FY 2008

Glenmark established its first commercial foothold in Europe by acquiring


Medicamenta a.s, Czech Republic in 2007

Glenmark also established its presence in Romania & Bulgaria in 2008

Revenues in $ mn

ending Mar08

* Projected

ending Mar09

ending Mar10

44

Glenmark Pharmaceuticals Limited: Specialty Business


Europe: Strategy for the future

Focus on CEE (Central Eastern European) markets which are primarily branded
in nature

Build/acquire front end infrastructure in CEE markets through sales force over
the next 5 years

Transition front-ends to selling/co-promoting Glenmarks proprietary


medications that would reach the market in the next 3-5 years

45

Glenmark Pharmaceuticals Limited: Specialty Business


Europe Branded Generics Market Key characteristics

The opportunity in the branded generics market lies mostly in the Central Eastern
European (CEE) countries and some new member states of the EU like Romania &
Bulgaria

Glenmarks focus is on the six largest brand markets of Europe


Market size
2008(in $ bn)

Per Capita
GDP spend (in
$)

Branded Generic
Penetration by
Value

Poland

6.4

867

50%

Czech
Republic

3.7

1479

45%

Hungary

>3.0

1337

35%

Romania

2.2

NA

NA

Bulgaria

> 1.0

NA

NA

Turkey

> 6.0

586

NA

EU 15

> 150

3100

US

> 250

6401

46

Glenmark Pharmaceuticals Limited: Specialty Business


Europe: Plans for FY 2009

Double revenues each year for the next 3-4 years


Enter Poland, Hungary and Turkey through organic/inorganic means
Plan to launch at least 5 products
Revenue contribution *

FY 2009
ending Mar09

* Projected

FY 2010
ending Mar10

47

Glenmark Pharmaceuticals Limited: Specialty Business


US: plans to enter the specialty segment in the near future

Initiate operations in the US during FY 2009


Evaluate acquisition of a specialty company/brands with a primary care sales force
Glenmark intends to conclude this acquisition over the next 12-18 months

48

Glenmark Pharmaceuticals Limited: Specialty Business


Infrastructure and facilities
Location

Production Lines

R&D Facility, Navi


Mumbai

NCE Research and Process Development

Regulatory Approvals
NA

R&D Facility,
Switzerland

Biologics Research

NA

Nasik, Maharashtra,
India

Solid orals, liquid orals, & external creams,


powders and capsules for regulated
markets

Brazil (ANVISA), Ethiopia, Zimbabwe, Uganda,


Nigeria; Tanzania, Ghana, R.D. Congo, Sudan,
South Africa (MCC )

Baddi, Himachal
Pradesh, India

Solid orals, semi-solid and liquid orals as


well as external preparations like lotions,
creams, capsules, etc. for India and semiregulated markets

US FDA, MHRA, TPD Canada, Nepal

Sao Paulo, Brazil

Solid orals, semi-solid & liquid orals for


Latin America

ANVISA

Vysoke Myto, Czech


Republic

Solid and semi-solid orals

SUKL, Czech Republic

Expansion Plans

New formulation plant in India to be commissioned in FY 09


NCE API facility in India to be commissioned in FY 09
49

Glenmark Pharmaceuticals Limited: Specialty Business


Financials and Projections Organic growth only
Revenues
In $ mn*

303

377

504

CAGR ~29 %

Business Mix

(ending Mar 08)

Profits
In $ mn

93

(ending Mar 09)

123

(ending Mar 10)

157

CAGR ~ 30%

In $ mn (Assumed exchange rate of ~40.28 INR/USD for FY08 and ~ 40 INR/USD for FY09 and FY10)

50

Glenmark Pharmaceuticals Limited: Specialty Business


Summary of key objectives FY 2009

Ensure at least eight molecules are in the clinical stages


Ensure at least five molecules are in the Ph II clinical trial stage
Ensure four molecules are partnered out by FY 09 (including Oglemilast &
GRC 6211)

Initiate acquisition of specialty front end in the US


Enter 7-8 new markets in Europe and RoW markets
Launch over 100 products and file for over 300 products approvals across
geographies

51

Glenmark Generics Ltd. (GGL)


Generics Business

Agenda
Glenmark
Glenmark Pharmaceuticals Limited (GPL) Specialty
Business

Glenmark Generics Limited (GGL- wholly owned sub. of


GPL) Generics Business

Glenmark Consolidated Financials and Projections

Safe Harbour Statement


This presentation has been prepared by Glenmark.
The information, statements and analysis made in this presentation
describing companys objectives, projections and estimates are forward
looking statements and progressive within the meaning of applicable
security Laws and Regulations.
The analysis contained herein is based on numerous assumptions.
Actual result may vary from those expressed or implied depending upon
economic conditions, government policies and other incidental factors.
No representation or warranty, either expressed or implied, is provided
in relation to this presentation. This presentation should not be regarded
by recipients as a substitute for the exercise of their own judgment.

54

Vision for Glenmark Generics Limited (GGL)


Global Integrated Generic & API leader

Product Portfolio
170 generics on the US market
70 generic dossiers for EU markets
Over 50 % of revenues from niches

Target 2015

Strate
gy

Market Presence
Presence in Japan, South Africa & other generic markets
Front ends in Japan and key EU markets along with NA

Market Positioning
Key Generic Player
Preferred supplier of APIs

Expand Niche
Product Portfolio
Increase
Geographical Reach
Vertical Integration

55

Glenmark Generics Ltd. - Business Unit Structure

Glenmark Generics Ltd. (GGL)

Finished Dosage Formulations

North
America

Europe

API

Argentina
(Oncology)

API

56

North America

Glenmark Generics Limited: Generics Business


North America Performance FY 2008

Revenues in $ mn

ending Mar07

ending Mar08

ending Mar09

ending Mar10

Highlights

Doubling of portfolio: 28 products on the market

Entry into dermatology with launch of five Clobetasol products

First semi-exclusive product : First 180 day shared exclusivity for Glenmark - Oxcarbazepine

Garnered over 20-25% market share in most products

* Projected

58

Glenmark Generics Limited: Generics Business


North America: The US Market
The Market

$ 286 bn
65% generics by volume represent 20% of the
market by value

Political climate increasingly supportive of


generics to lower healthcare costs

Market Characteristics

Increasing competition in me-too generics


Authorized generics and shared exclusivities
reducing upsides from 180-day exclusivities

Customers prefer vertically integrated companies


Opportunities

with long term plan

In the next 3-5 years, drugs worth $ 60-70 Bn are


going off-patent

Values in $ Bn
59

Glenmark Generics Limited: Generics Business


North America Glenmarks rise as a generic player
GGI, USA (Glenmark Generics Inc.) launched the
Background

Product Portfolio

first product in Jan 2005

Registered net revenues of $ 140 mn in FY 2008


28 products on the market
> 30 products filed with USFDA
Presence in controlled substances, hormones,
oncology, modified release and dermatology

Portfolio of marketed products has doubled each


year during the last three years

Revenues crossed $ 100 mn in first three years of


ending Mar06

ending Mar07

ending Mar08

Highlights

operations

Received 180 day exclusivity for Oxcarbazepine


Filed PIVs (FTF opportunities) for Zetia, Tarka,
Strattera & Crestor
60

Glenmark Generics Limited: Generics Business


US: Plan for ANDA Filings
ANDAs filed / marketed

Till FY

FY

FY

2008

2009

2010

Dermatology

10

26

Controlled Substance

12

Modified Release

10

10

26

Hormones

12

Oncology

First to File (P-IVs)

12

Immediate Release

32

40

Total

61

37

39

137

(Includes partner filings)

Total
Filings

61

Glenmark Generics Limited: Generics Business


US Product Portfolio: Dermatology
Total Topical Derma Market is $4.3 bn of which over
The Market

50% of sales are generic

Higher barriers to entry due to development costs


Higher margins based on fewer competitors
Key generic players include: Fougera, Perrigo, Taro
Partnership with Paul Capital for clinical
development of 16 dermatology products

GGLs Portfolio

Only Indian Company with India based


dermatology portfolio [1 already launched; 18
products anticipated (current market size $390
mn) to be launched within next 3 years]

Fillings (Cumulative)

ending Mar08 ending Mar09

ending Mar10

62

Glenmark Generics Limited: Generics Business


US Product Portfolio: Controlled Substances (CS)
Total CS Market is valued over $12 bn
Key generic players include: Mallinckrodt, Watson, Endo
High barriers to entry:
The Market

DEA licensures required


Limitations on importing controlled substances from foreign
countries

Higher margins on controlled substance products due to


limited players

Controlled substance portfolio (current market


GGLs Portfolio

size $ 200 mn)

3 controlled substances already launched


7 additional products anticipated to be launched
within next 3 years

Fillings (Cumulative)

ending Mar08 ending Mar09 ending Mar10

63

Glenmark Generics Limited: Generics Business


US Product Portfolio: Modified Release
Total sales revenue for Modified Release oral solids is
over $22 bn

The Market

Higher barriers to entry


Difficult to develop
Unique technologies
Higher margins on modified release products due to
limited players.

Several modified released products in pipeline and


GGLs Portfolio

already filed [14 products anticipated (current market size


$1.6 bn) to be launched within next 3 years]

Fillings (Cumulative)

ending Mar08 ending Mar09

ending Mar10

64

Glenmark Generics Limited: Generics Business


US Product Portfolio: Hormones
Total Solid oral dosage Hormones Market is
approximately $5 bn

The Market

Key generic players include: Barr & Watson


Higher margins on Hormones Products
Limited players
Dedicated facility required
Higher cost of bio-studies
Only Indian Company with India based hormones

GGLs portfolio

portfolio [10 products anticipated (current market size $1


bn) to be launched within next 3 years]

Fillings (Cumulative)

ending Mar08 ending Mar09 ending Mar10

65

Glenmark Generics Limited: Generics Business


US Product Portfolio: Oncology
Total Oncology Market in the United States is over $10 bn
Key generic players include: Teva Sicor, Ben-Venue &
The Market

Barr

Higher margins on Oncology Products


Limited players
Dedicated facility required
Portfolio includes a mix of 14 solid oral dosage and 13

GGLs portfolio

injectable products (Total market size: >$ 7.5 bn)

Fillings (Cumulative)

ending Mar08

ending Mar09 ending Mar10

66

Glenmark Generics Limited: Generics Business


US Product Portfolio: FTF ANDA Ongoing
Litigation
Product

Brand Name

Plaintiff

IMS Sales

Ezetimibe

Zetia

Schering Plough

$ 1.8 bn

Atomoxetine

Strattera

Eli Lilly

$ 526 mn

Rosuvastatin Ca
(no litigation)

Crestor

--

$ 1.7 bn

Trandopril/
Verapimil

Tarka

Sanofi-Aventis

$ 95 mn

Fillings (Cumulative)

ending Mar08 ending Mar09

ending Mar10

67

Glenmark Generics Limited: Generics Business


North America: Strategy for future

Continue to focus on niche categories; expand presence into


other niche categories

Set Glenmark Generics apart as a preferred supplier to the


industry

Manage product portfolio to include a judicious mix of PI, PII, PIII


and PIV filings

Strive for vertical integration for most of our products in all


categories (including niche categories)

68

Glenmark Generics Limited: Generics Business


North America: Plans for FY 2009

Register growth of 45 %
Launch over 20 products and file over 35 products
Including dermatology, controlled substances, hormones and other
niche categories

Leverage partnerships with other generic players

Evaluate entry into 1 or 2 additional niche categories

69

Europe

Glenmark Generics Limited: Generics Business


The European Market

Market Size

$ 182 bn
Generic penetration is low as compared to the
North America in many of the countries

Market is broken down into several countries with


different requirements

To bring down the cost of publicly funded


Market Characteristics

healthcare is the main driver in promoting


generics

Europe is characterized with each country


having different regulatory authorities and
distinct pricing/reimbursement policies

Key markets with high generic penetration: UK,


Germany, Netherlands

Opportunities

Key markets with low generic penetration: France,


Italy, Spain, Belgium

Large no of products set to go off-patent in the next


3-5 years

71

Glenmark Generics Limited: Generics Business


Europe generics business is gearing up for future
GGEL (Glenmark Generics Europe Ltd.) was established
Background

in 2004

Majority of current revenues are as licensing income


from dossier customers

Already filed for five MAAs which have been


outlicensed to several Europen generic companies

Product Portfolio

Portfolio of more than 30 EU CTD solid and semisolids dossiers at various stages of development

Several supply deals are in place with leading


European generic players

Revenues in $ mn

* Projected

ending Mar08

ending Mar09

ending Mar10

72

Glenmark Generics Limited: Generics Business


Europe: Strategy for future growth

Establishing Glenmark 4-5 distribution front ends in Western European markets in


the next 3-5 years through organic/inorganic means in order to market own products
directly

Developing niche generic products, and partnering & creating alliances with EU
companies

Building up the infrastructure to support growth objectives and create a significant


presence in the EU markets

Licensing and distribution partnerships with strong local / Pan-EU partners with a
view to maximize the product portfolio and market opportunities

Continue to support finished dosage pipeline with backward integration into APIs

73

Glenmark Generics Limited: Generics Business


Europe: Plans for FY 2009

Acquire 1-2 generic distribution front ends in EU


Launch 3 products into several countries
File for at least 10 MAAs

Total MAA
Filings (cumulative)

ending Mar08

ending Mar09

ending Mar10

74

Oncology Business

Glenmark Generics Limited: Generics Business


Oncology market
Market Size

Total Market Size >$ 30 bn


Generic market worldwide > $ 8 bn
Lesser competition because of entry barriers
Difficult to develop molecules
Specially designed/dedicated manufacturing

Market Characteristics

facilities

Better operating margins due to lower price


erosion
Longer product life cycle as older therapies
continue to co-exist with newer ones

95 % of classic chemotherapy products are not


Opportunities

protected by patent which will ensure high


profitability in regulated markets (less competition)

Large no of products set to go off-patent in the next


3-5 years

76

Glenmark Generics Limited: Generics Business


Oncology generics business
Glenmark acquired the Argentinean marketing company
Background

Glenmark Generics S.A. (erstwhile Servycal S.A.) with a focused


oncology portfolio

Product Portfolio

Presence in oncology in over 23 countries


Caters to 75% of cancer therapy products
Robust product pipeline for the near future
Presence in cytotoxics, anti-hormonals & supportive
therapies

Plans to upgrade own dedicated manufacturing facility

Revenues in $ mn

* Projected

ending Mar07 ending Mar08

ending Mar09

ending Mar10

77

Glenmark Generics Limited: Generics Business


Oncology Business: Strategy for future growth
Use Argentina as a hub to spread the oncology
business
Use Argentina as
a hub for spreading the
oncology business

Continue to file dossiers and expand presence in


other Latin American and ROW markets

Develop product portfolio for regulated markets


and initiate oncology filings in regulated markets

First filing in the US and EU by FY 09/FY10


Increase coverage
for cancer
therapy products

Expansion of product portfolio to cater to 95%


Cancer therapy products

78

Glenmark Generics Limited: Generics Business


Oncology Business : Plans for FY 2009

Register growth of over 80 %


Enter 3-4 new countries including regulated markets
File over 90 products for approval across various countries

Total Dossier
Fillings (Cumulative)

ending Mar08

ending Mar09

ending Mar10

79

Active Pharmaceutical
Ingredients (API) Business

Glenmark Generics Limited: Generics Business


The Global API Market
Market Size

>$ 75 bn
Growth >10% (2005)
Increased consolidation in generic pharmaceutical
industry

More focus on higher value creating opportunities


Market Characteristics

driven by intellectual property

Stringent regulatory approval process in US/EU


leads to high switching costs

Increase in competition from Indian and Chinese


API suppliers

Large no of products set to go off-patent in the next


3-5 years

Opportunities

Many of the other historical less-regulated markets


are quickly shifting towards stricter regulations
limiting competition and opportunities for
established players like Glenmark

81

Glenmark Generics Limited: Generics Business


API Business
Background

API business spans across 80 countries including


regulated markets like US and Europe

> 50% of the revenues is from exports


Product Portfolio

Filed over 30 USDMFs till date


Filed several Canadian DMFs, EDMFs and
CEPs/CoSs

Sales in $ mn

* Projected

ending Mar07 ending Mar08 ending Mar09 ending Mar10

Highlights
Registered growth of over 45%
Exports contribute over 50% of the revenues
Initiated commercial supplies to various customers
82

Glenmark Generics Limited: Generics Business


API Business: Drivers for future growth
Continue to be a
preferred 3rd party
API supplier

Expand product portfolio


and market presence

Partner with generic companies to capture


first and alternate source opportunities
Establish close relationship with major
generic players globally to capture high end
opportunities

Continue to file DMFs across geographies


Increase focus on entry into new markets
Expand API capabilities to support dosage in niche areas
(hormones, dermatology, controlled substances etc.)

Focus on difficult to develop molecules


Focus on IP

Investments to
ramp up infrastructure

and generating IP around molecules

Invest in building infrastructure in order to


cater to increased demand and growth

83

Glenmark Generics Limited: Generics Business


API Business: Plans for FY 2009

Register growth of over 40 %

File over 15 USDMFs

Ramp-up commercial supplies to regulated markets on upcoming approvals of


ANDAs/Dossiers filed and pending at 3rd party customers

Focus on development of over 15 APIs annually to provide cost and timing advantage to
complement US and Europe generic filings

Enter 5-6 new markets

Till FY 2008
US DMF
Fillings

ending Mar08

31

FY 2009

FY 2010

ending Mar09

ending Mar10

18

18

Total Filings

67

84

Glenmark Generics Limited: Generics Business


Plants and Infrastructure
Location

Production Lines

Regulatory Approvals

R&D Facility, Navi


Mumbai

Formulation/API development facility,


Bio-analytical and clinical R&D

NA

Goa, India

Oral solids, semi-solids for regulated


markets Colvale
Hormones for regulated markets
Colvale
Oral solids - Kundiam

US FDA, Canada (TPD), South Africa (MCC), Brazil


(ANVISA), Quintiles (a CRO; for EU-GMP), Ethiopia
Health Authority, Brecon (a CRO) & Tunisia , UAE,
UK (MHRA); Botswana

Oncology plant,
Argentina

Oncology products for regulated


markets

Local FDA GMP approved

Ankleshwar, India

Manufacturing blocks for regulated


markets

US FDA; UK (MHRA)

Kurkumbh, India

Manufacture of intermediates & APIs


for India and semi-regulated markets

Mohol, India

Local FDA GMP approved

Expansion Plans
New Formulation plant at Jambusar SEZ
New API Facility at Jambusar SEZ
New R&D Centre at Taloja (India) to be commissioned by FY 09
Upgradation of Argentina plant for Onco products
85

Glenmark Generics Limited: Generics Business


Financials and Projections Organic growth only
Revenues
In $ mn*

196

296

428

CAGR ~48 %

Business Mix

(ending Mar 08)

Profits
In $ mn

64

(ending Mar 09)

87

(ending Mar 10)

125

CAGR ~ 39%

In $ mn (Assumed exchange rate of ~40.28 INR/USD for FY08 and ~ 40 INR/USD for FY09 and FY10)

86

Glenmark Generics Limited: Generics Business


Summary of key objectives for FY 09

Launch at least 5 products every quarter in the US generic market


Launch at least 3 products in EU across several markets; File at least 10 MAAs
with focus on niche areas

File over 30 ANDAs in the US generic market with focus on niche categories
File at least 15 USDMFs
Acquire 1-2 front ends in WE territory
Commissioning of new R&D facility at Taloja

87

Agenda
Glenmark
Glenmark Pharmaceuticals Limited (GPL) Specialty Business
Glenmark Generics Limited (GGL- wholly owned sub. of GPL)
Generics Business

Glenmark Consolidated Financials and Projections

Glenmark
Consolidated Financials and Projections

(ending Mar 08)

(ending Mar 09)

(ending Mar 10)

Consolidated Revenues ($ mn)

499

673

932

PAT ($ mn)

157

210

282

Basic EPS (INR)

25.81

34.52

46.36

P/E (Based on Rs. 600 Share Price as


at 25 Apr, 2008)

23.25

17.38

12.94

In $ mn (Assumed exchange rate of ~40.28 INR/USD for FY08 and ~ 40 INR/USD for FY09 and FY10)

89

Thank you

90