products - Glenmark

Our Vision : To emerge as a leading
research-based, global, integrated pharmaceutical company

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This presentation has been prepared by Glenmark
Pharmaceuticals Ltd. The information, statements and analysis
made in this presentation describing company’s 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
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Contents
• Background
• Strategy and Business Units
• Business Unit Overview
• Financials and Projections
• Summary

Background
History
Identity / Scope
Global Footprint
Financial
Performance
Market
Capitalisation
• 30-year old company
• Listed on Indian bourses in 1999 at a market
cap of $ 40 Mn
• Integrated, operating in research, manufacturing
& marketing of pharmaceuticals
• Business interests span formulations and bulk
drugs across regulated and ROW (rest-of-theworld)
markets
• Headquartered in Mumbai, India
• Operates in over 80 countries
• Over 60% of revenues come from outside India
• Results in FY 2007 (ending March 31, 2007):
• Revenues for FY 2007 of $281 Mn
• Consolidated profit after tax of $70 Mn
• ~USD 1.95 Bn (As at Apr 24, 2007)
1

Strategy and Business Units
2

Vision 2015
By 2015, Glenmark aims to be a specialty company with
• The launch of 2 proprietary molecules between 2010 and 2014 through own
development and in-licensed molecules
• Less than 30% of revenues coming from the Generics and API businesses
• A global specialty business including specialty front ends for the US, key
European and ROW (Rest-of-the-World) markets
In the medium term
• Continuous pipeline development
• 1-2 NCEs entering into clinics every year
• NBEs (Novel Biological entities) capability and infrastructure development
• Own development and in-licensed NCEs and NBEs
• Out-license NCEs and ensure co-promotion rights in the US and select
European markets
• Subsequently, move up the value chain by doing further clinical development
• Build or acquire brand marketing infrastructure in ROW/EU markets
• Establish the “Glenmark” brand globally
3

Glenmark’s business is organised into business
units
CEO
R&D
Finished Dosage Formulations
API
NCE
Biologics
(Swiss)
US
Europe
Rest of the
World
(ROW)
API
Semi-
Regulated
Markets (SRM)
Latin
America
India
4

BU wise contribution
FY07
FY08
11%
18%
16%
21%
11%
11%
2%
10%
34%
11%
15%
27%
13%
NCE
US
SRM
Latin America
India Formulation
API
Europe
Revenues 281 419
5

Research and Development
5

Build proprietary pipeline of NCEs/Biologics in
high growth areas with good licensing potential
RESEARCH FOCUS
Metabolic Disorders
• Diabetes (Type II)
• Obesity
Inflammation
• Asthma/COPD
• Pain
NCE RESEARCH
NCE Research – In Mumbai, India
• Focused capability building over 5
years – 200 scientists; spend ~5% of
revenues
• Eminent scientific advisory board
• 6 leads – 3 in Ph II, 2 entering Ph I
shortly and 1 in Pre-clinical
• Target: 1-2 NCEs into clinics every
year
BIOLOGICS
Oncology and Inflammation
Biologics Research – In
Switzerland
• Lab commissioned –25+
researchers
• Further expand Biologics
capabilities through in-licensing
and potential acquisitions
• Target : First lead in to clinics
by 2009
7

Progress on 6 Compounds …
Compound
Target
Primary Indications
Status
Target
Launch
GRC 3886
PDE 4
Asthma, COPD
Ph II
2009/10
(Oglemilast)
GRC 8200
DPP IV
Diabetes (Type II)
Ph II
2010
GRC 6211
VR 1
Osteoarthritis, Dental Pain,
Incontinence, Neuropathic
Pain
Ph II
2011
GRC 10801
CB 1
Obesity
Ph I by Q1
FY08
2012
GRC 10693
CB 2
Neuropathic Pain,
Osteoarthritis and
Ph I by Q2
FY08
2012
other Inflammatory Pain
GRC 4039
PDE 4
Rheumatoid Arthritis,
Inflammation, Multiple
Sclerosis
Ph I in Q2
FY08
2012
8

NCE Pipeline
Lead
Target
Indication
Stage
Status
GRC 3886
(Oglemilast)
PDE 4
Asthma,
COPD
Ph II
• Completed Ph II trial for “exercise induced
asthma”
• Phase II B for Asthma, COPD likely to be
initiated soon
• Survey by R&D Directions classified GRC 3886
as one of the Great 100 Investigational Drugs
• $ 30 Mn expected from Forest Inc.
• In discussions with potential European Partners
GRC 8200
DPP IV
Diabetes
(Type II)
Ph II
• Phase II clinical development in progress
• Tied up with Merck KGaA of Germany in Oct 06
to develop, register and commercialize GRC
8200 and its combinations in US, Europe, Japan
• Glenmark retains exclusive marketing rights for
India and will co-commercialize the drug in RoW
• Total deal size is EUR 190 Mn, with EUR 25 Mn
as an up-front payment and the remaining
milestone payments upon successful
development, launch
• Upon commercial launch, Glenmark will supply
the API to Merck KGaA and will receive royalties
on net sales of the product
9

NCE Pipeline
Lead
Target Indication Stage
Status
GRC 6211
VR 1
Osteoarthritis,
Dental Pain,
Incontinence,
Neuropathic
pain
Ph II
• Exciting target – after Merck licensed
compound from Neurogen (currently in Ph
II) and Pfizer licensed compound from
Renovis (currently in pre-clinicals)
• Completed Phase I this month. Study
conducted on 72 healthy subjects
• Initiating Phase IIA proof of concept stydy
for dental pain in Europe which is expected
to complete by Dec 07
• Glenmark currently in discussions for
potential licensing. Timing of licensing
would depend on the deal terms and ability
to get co-promotion rights in some of the
regulated markets
• Glenmark is in a position to be an early
launcher in this class
GRC 10801
CB 1
Obesity
Ph I in
Q1
FY08
• Glenmark’s lead target profile will clearly
differentiate us on aspects of safety and
drug metabolism
• We expect to be third/fourth in class with a
clear differential over existing compounds
10

NCE Pipeline
Lead
Target Indication Stage
Status
GRC 10693
CB 2
Neuropathic
pain,
Osteoarthritis,
Rheumatoid
Arthritis and
other anti -
inflammatory
pain
Ph I Q2
FY 08
• Likely to be early launcher with an oral CB2
agonist. Currently Pharmos has an IV
compound in Ph II and GSK has an oral
compound in Ph II
• Very exciting target as non-narcotic,
peripherally acting, excellent pain-control
and without addiction potential associated
with Opoids. Potential applications in
Rheumatoid Arthritis.
• Currently in discussion with several bigpharma
companies for potential licensing
GRC 4039
PDE 4
Rheumatoid
Arthritis,
Inflammation,
Multiple
Sclerosis
Ph I in
Q2 FY08
• After the withdrawal/setback of COX-2s
and the void that exists in RA therapy, we
believe this could be a potential blockbuster
opportunity
• The lead is also showing promise in
Animal models in RA and other
inflammatory conditions
11

Biologics research in Switzerland in early phase
Status and Progress
• Biologics Research Centre established with an aim to diversify into research activities
to cover biologics
• Employing 25+ scientists with Biologics research experience from Switzerland and
Europe
• Glenmark targets its first lead to enter the clinics by 2009 followed up with 2 more by
2010
• To expedite the process for biologics research, Glenmark and Dyax have entered into
a collaboration in March 2007
Dyax-Glenmark tie-up to identify therapeutic antibodies
• Glenmark anticipates 3 highly promising New Biological Entities (NBEs) coming out of
this collaboration
• Under this arrangement, Glenmark will have global marketing rights for the NBEs
• Dyax will perform funded research for three of Glenmark’s targets in the areas of
inflammation and oncology
• Benefits to Glenmark include access to Dyax’s screening capabilities, their experience
in antibody discovery, the patent portfolio and the licenses in the field of antibody
discovery held by Dyax
Targets its first lead to enter clinics by 2009
12

Finished Dosage Formulations
13

USA – Generic Formulations
Progress
• Revenues from the US front end has grown dramatically from USD 13 Mn in FY
2006 to USD 50 Mn in FY 2007, a growth of 286% with 13 generics on the market
• Excellent sales performance – locked in excess of 20-25% of the US market on
most products within first year of launch
• Glenmark has 36 ANDAs undergoing USFDA approval process / launch
• The filings include 2 para IV filings along with 5 dermatology and 2 extended
release (XRs) products
• Partnerships have helped multi-pronged build out of the product portfolio
Company
No of products
Partner’s role
Glenmark’s role
Lehigh Valley Technologies
(LVT)
7 (controlled
substances)
Develop, Manufacture
Market in US
Shasun and InvaGen
20 (Miscellaneous
OSDs)
Develop, Manufacture
Market in US
Paul Capital partners
16 (dermatology)
Fund product
development
Develop, manufacture
and market in US
Aspen/LVT
5 (controlled
substances)
Develop, Manufacture
Market in US
14

Products approved in the US
Product
Dipyridimole
Esterified Estrogen
(EEMT)
Fluconazole
Gabapentin
Meloxicam
Zonisamide
Nystatin
Morphine Sulphate
Naproxen
Nitroglycerin
Oxycodone
Codeine Sulphate
Fosinopril
Category
Vasodialating agent
Hormone replacement
Antifungal Antibiotic
Anticonvulsant
NSAID
Anticonvulsant
Antifungal Antibiotic
Controlled substances
NSAID
Vasodialating agent
Controlled substances
Controlled substances
Hypotensive agent
Expects to get approvals for 6-7 ANDAs in Q1FY08
15

USA – Generic Formulations
Going Forward
• Plan to launch 15-20 products during the year; Expects to get 6-7 product
approvals in Q1 FY08
• File 15-20 internal ANDAs in FY08; Includes XRs, IRs, Derma products and a
healthy and exciting mix of P-II, P-III P-IV opportunities
• Also intend to file 8-10 third party ANDAs
• Niche topical generics: working on 20+ steroidal, non-steroidal and combination
topicals
16

Europe – Start-up phase
Progress
• As part of the strategy of expanding inorganically in select branded generics
markets in Europe, Glenmark has concluded a deal to acquire Medicamenta, a
pharmaceutical marketing and manufacturing company in the Czech Republic
• Medicamenta operates in the branded generic markets of the Czech Republic
and Slovakia and has projected sales of USD 8Mn for calendar year 2007
• Developing niche generic products, and partnering & creating alliances with
European companies
• Entered into a joint developing, filing and marketing deal for 8 derma products
with Merck Generics, Germany for the European region
Going forward
• Glenmark to continue looking for acquisitions opportunities in select branded
generic markets and aims to conclude 1-2 more acquisitions (of value USD 10-
20Mn) in FY08 in the Central and Eastern Europe markets
17

Latin America
Current Status
• Extended range of oncology
products from Servycal – Several
products launched into the
Brazilian market; multiple products
registered in ROW markets
• Expanded field force and also
commenced commercial operations
in several additional countries; now
presence established in 10
countries (including Brazil and
Argentina)
• Filed 94 dossiers in Latin America
and received approvals to market
37 products.
Going forward
• Expand presence in oncology to
other Latin American markets as
well as other key ROW markets: use
Argentina as the hub for oncology
• File an additional 20 dossiers in
markets across Latin America;
launch 10-12 new products in Brazil
• Grow Rest of Latin America with
greater focus on countries such as
Venezuela , Colombia etc.
• Divisionalisation for greater focus –
segments include dermatology,
respiratory, gynaecology &
oncology
• 10-15% EBIDTA from Latin
American operations in FY08
18

Semi-Regulated Markets (SRM)
Current Status
• Revenues increase fuelled by
growth in Russia and
acquisitions in South Africa
• Started operations in 9 new
countries
• Completed 311 filings and
received 207 approvals for
products across markets
• Consolidated position in
existing markets
• increased field force
• launched new products
• reviewed portfolio to
meet local requirements
Plan going forward
• Continue focus on top-15 SRM markets
(Including Russia, South Africa,
Philippines, Malaysia, Nigeria, Sri Lanka)
• Consolidate position in Russia with
growth in excess of 50%; File for 10-15
products; launch 8-10 products in Russia
• Expand in South Africa – use the India
advantage to file several products
• Achieve over 60% growth in revenues
over FY 2007
• Evaluate acquisition candidates as well
as in-licensing opportunities in highpotential
SRM markets
• Diversify portfolio to include an oncology
line – leverage the acquisition of Servycal
in Argentina
• Continue registration of products across
geographies
19

India Formulations
Current Status
• Value growth of over 22% vis-à-vis IPM which grew at 15.8% (ORG-IMS Feb 07)
• Glenmark ranked amongst the top 3 in dermatology, strong presence in over
10 segments including female healthcare, paediatrics, respiratory, antiinfectives,
cardiovascular, diabetology, oncology
• Dermatology, respiratory and anti-infectives segments continue to provide
over 60% of the India formulations revenues
• Launched 6 first-to-launch-in-India molecules in FY07. New products and
novel combinations launches in the year total to 36
• Created 7 retail divisions, 1 institutional division & 1 targeting family
physicians for improved focus
• Grew field force (currently > 1900 medical representatives) and increased
focus on productivity improvements
• Increased focus on chronic lifestyle diseases
• Driving supply chain cost down; new plant at Baddi for tax-efficiencies fully
on-stream
• Commenced in-licensing and co-marketing tie-ups for novel products
20

India Formulations
Going forward
• Grow revenues by 15% p.a.
• Launch over 30 products in FY08
• Strengthen presence in respiratory, pain management and metabolic diseases – in
preparation for own NCE launches
• Increase in-licensing efforts for novel products to augment own pipeline
• Continue launching differentiated branded generics; focus on building power
brands
• Grow mass-market division, Milieus, through increased product launches, sales
force hires and geographic expansion
• Improve cost-efficiencies and cash-cycle management
• Achieve payback on Baddi facility by increasing products routed through the
plant – within 2 years of plant commissioning
21

Active Pharmaceutical Ingredients
(APIs)
22

Active Pharmaceutical Ingredients
Current Status
• Revenue increase (34%) driven by:
• Growth in regulated markets
• New product introductions
• Mix of revenues from segments:
• India and co-marketing – 46%
• Exports – 54%
• Filed 11 US DMFs, 8 EDMFS, 5
CEPs and 3 Canadian DMFs in FY07
• Commenced commercial supplies
of DMFs during year; several
samples, validation, pivotal batches
to global generic players for their
ANDA/Dossier filings
• Filed 94 process patents in the last
3 years
Plan going forward
• Revenue growth in excess of
25%
• Complete capacity expansion in
Ankleshwar, start construction
in Aurangabad
• File 12-14 DMFs for the year
• Commercial supplies to
regulated markets to increase
dramatically with several
ANDAs/Dossiers filed and
pending from our 3rd party
customers
• Develop several APIs annually
to provide cost and timing
advantage to complement our
US and Europe generic filings
• Continue to be a preferred 3 rd
party API supplier to the generic
industry
23

Financials and Projections
24

Financials and Projections
Performance in FY 2007
YTD FY
2007 3
(In USD Million)
FY 2005 1 6.41
Audited
Audited
FY 2006 2 23.20
Un Audited
Operating income (A)
139.87
171.09
281.38
Expenditure (B)
104.27
140.11
184.41
EBITDA (Operations) (C =A-B)
35.60
30.98
96.98
EBT (Operations) (D)
27.90
22.41
78.16
Other Income (E)
1.19
2.90
3.64
PBT (F=D+E)
29.09
25.31
81.80
PAT (G)
24.48
19.87
70.48
Basic Earnings per share (in rupees)
8.97
7.28
26.06
Diluted Earnings per share (in rupees)
8.16
Note : 1. Average conversion rate for FY 2004-05 of Rs. 44.94 / USD 1.00
2. Average conversion rate for FY 2005-06 of Rs. 44.28 / USD 1.00
3. Average conversion rate for FY 2006-07 of Rs. 44.14 / USD 1.00
25

Financials and Projections – Base Business
Projections (in Mn USD)
Revenues
In USD Mn*
350
8
70
47
250
Europe
30
108
API
India Formulation
97
55
SRM
Latam
Business Mix
41
42
USA
32
50
90
FY 2007 FY 2008
Net profit (Mn. USD)
Basic EPS (INR)
P/E (Based on Rs. 686 Sh Price
as of 24.04.07)
42
15.57
44.06
65
22.93
29.92
* In USD Mn (Assumed exchange rate of 44.14 for FY07 and ~42.0 INR/USD and for FY08
26

Financials and Projections - Milestones
Milestone Projections (in Mn USD)
Revenues
In USD Mn*
31
69
GRC 8200
31 M USD
All
Milestones
69 M USD
FY 2007
FY 2008
Net Profits 28 60
* In USD Mn (Assumed exchange rate of 44.14 for FY07 and ~42.0 INR/USD and for FY08
27

Financials and Projections – Summary
Projections (in Mn USD)
Revenues
In USD Mn*
281
419
69
Business Mix
31
30
97
41
32
50
8
47
108
55
42
90
NCE
Europe
API
India Formulation
SRM
Latam
USA
FY 2007 FY 2008
Net profit (Mn. USD)
Basic EPS (INR)
P/E (Based on Rs. 686
Sh Price as of
24.04.07)
70
26.06
26.25
125
44.10
15.56
* In USD Mn (Assumed exchange rate of 44.14 for FY07 and ~42.0 INR/USD and for FY08 28

Summary
29

Summary - key target milestones by FY 2008
• Research
• Conclude 2 more licensing deals for NCEs by end FY 2008
• Aim to progress Phase II for GRC 8200, GRC 3886 and GRC 6211; Initiate
Phase I trials on 3 NCE compounds (GRC 10693, 4039 and 10801)
• In-license biologics/NCEs to consolidate pipeline
• Formulations
• APIs
• Conclude 1-2 more acquisitions in Europe
• Evaluate/conclude acquisition opportunities in high impact SRM markets
• Market 25+ products in the US market
• File 15-20 solid dose ANDAs; include XRs and P-IV opportunities
• File 12-14 DMFs
30

Thank you
For queries on Glenmark Pharmaceuticals Ltd,
please contact: media@glenmarkpharma.com
For queries on Glenmark Generics Ltd,
please contact: connect@glenmark-generics.com