Title: November 08
1 2Safe 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
3Content
Glenmark A Snapshot
The Evolving Pharma Value Chain
Re-organisation of Glenmark
Glenmark Pharmaceuticals Ltd. (GPL)
R D - H1 Highlights Program Details
SBU - H1 Highlights Road Map
Operations H1 Highlights Near Future Plans
Financials Projections
Glenmark Generics Ltd. (GGL)
SBU - H1 Highlights Road Map
Operations H1 Highlights Near Future Plans
Financials Projections
Glenmark Consolidated Financials
4Glenmark -A Snapshot
5Year 2000
Turnover - USD 38 Mn 2 Formulations
Manufacturing Facilities Operations in 27
countries Sales from International operations
8 Initiation into NCE research
Glenmark -A Snapshot
Year 2008
Research Based
Global
- One of the leaders in drug discovery amongst
Indian companies - 13 New molecules under development with 6 in
clinics - Over USD 110 Mn of cash recd. from NCE
out-licensing deals - Further milestones worth over USD 600 Mn
Integrated
- Operations in over 95 countries with more than 20
subsidiaries - Over 5500 employees across 5 continents
- 11 manufacturing facilities in 4 countries
- Front-ends in key markets worldwide
- 3 API plants
- 8 Finished dosage plants
- 6 research facilities
6Rapid Changes in Global Scenario The evolving
Pharma Value Chain
Proprietary/ Branded Business
Key Requisites- Innovation Brand
Building Pull for products Marketing front
ends
VALUE CHAIN
Branded Generic Companies will either transition
up the value chain towards Proprietary
business OR They will transition to the other end
towards pure generic business
Branded Generic Business
Key Requisites- Low costs low margins Forging IP
challenges Push for products Efficient
Distribution
Pure Generic Business
7The Re-organisation of Glenmark Separate focus
on both business domains Proprietary Generics
GLENMARK
Effective April 2008
GLENMARK PHARMACEUTICALS LTD (GPL)
GLENMARK GENERICS LTD (GGL) (A subsidiary of the
parent co.)
- Specialty/ Proprietary Business
- Focus on New Drug Development and branded
products market
- Pure Generics Business
- Focus on marketing of APIs and generic
formulations
8GPL GGLCurrent Infrastructural Support In
line with Business Requirements
1 dosage plant Czech Republic
Biologics RD - Switzerland
Clinical RD Oxford UK
1 API plant -Gujrat, India
1 dosage plant -HP, India
1 dosage plant -Maharashtra, India
Generics RD -India
Formulations RD-India
NCE RD-India
3 dosage plants -Goa, India
1 dosage plant -Brazil
2 API plants Mtra, India
Clinical Research Unit- Mtra, India
1 dosage plant -Argentina
9GPL GGLClearly Demarcated Focus Areas
Business Imperatives
In past 6 six months, GPL and GGL have
successfully progressed as Independent Entities
10GPL Span of Operations
GPL
11GPL Pioneering Transformation by Transitioning
from Branded Generics domain to Innovation-led
proprietary biz. domain
Clinical RD Oxford UK
IPM, Regulatory, Global BD- USA
Biologics RD - Switzerland
- Establishing Global Centers of Excellence
- Small Molecule Research in India
- Biologics Research in Switzerland
- Clinical Research in Oxford UK
- Intellectual Property Management, Regulatory
Global Business Development USA
NCE RD-India
12RD H1 Highlights
- Clinical Research Centre established in Oxford,
UK. Aims to be the best-in-class set-up in
Clinical Operations, Biometrics and
Pharmacovigilance - Initiated Phase IIb Asthma and COPD studies on
Oglemilast (GRC 3886) - Melogliptin (GRC 8200), a treatment for type II
diabetes, completed phase IIa and is currently
undergoing phase IIb studies - Completed Phase 1 trials on GRC 4039, a drug
being pursued for RA and other inflammatory
conditions - GRC 10693, a CB2 agonist targeting various pain
conditions, initiated phase I trials in EU - Filed the companys first IND (Investigational
New Drug Application) with the US FDA through GBR
500, a monoclonal antibody, after successfully
completing pre-clinical studies - Eli Lilly, Glenmarks partner for GRC 6211,
suspended further clinical development of the
molecule in Osteoarthritic pain
13Progress on pipeline A Snapshot
Further OA clinical development suspended
One NCE 3 NBEs are in discovery stage
14Program Oglemilast (GRC 3886 )
15Oglemilast (GRC 3886 ) Strengths of the Program
- Strengths of the program-
- Potential first-in-class opportunity
- Disease modifying properties of PDEIV inhibitors
- Validated pathway in respiratory disease
- No emesis is seen, unlike other compounds of its
class. Hence larger therapeutic window - Oral, once daily dosing, provides compliance
advantage
16Oglemilast (GRC 3886 ) Key Differentiator from
other compounds in class Lack of Emesis
Previous PDE4i which went through late stage
development suffered from low efficacy and side
effects related to emesis
- Oglemilast designed for lack of emesis as a side
effect - Possibility to escalate doses and achieve higher
efficacy
Dose Emetic effect in ferrets
17Oglemilast (GRC 3886 ) Clinical Development
Update
Clinical Development
Both COPD study and Asthma study are progressing
well
18Program Melogliptin (GRC 8200)
19Melogliptin (GRC 8200) Strengths of the Program
- Strengths of the program-
- DPP IV is one of the most promising treatment
pathway to come up in the large and growing
diabetes market - Current analyst estimated
market size is over USD 35 Bn by 2015 - GRC 8200 has the potential to be best in- class
in terms of safety and efficacy - Initial data suggests possibility for better
efficacy than other competing DPP4s - Validated development pathway
- Currently being developed as monotherapy as well
as combination therapy with other anti-diabetic
molecules
20Melogliptin (GRC 8200) Potential to be
best-in-class
- Amongst the most potent molecules in DPP-IV class
- High specificity for DPP-IV
- Potential to have high efficacy in comparison to
other molecules in class (most have low HBA1C
reduction levels)
21Melogliptin (GRC 8200) Clinical Development
Update
Clinical Development
22Program GRC 6211
23Program GRC 4039
24GRC 4039 Clinical Development Update
Clinical Development
25Program GRC 10693
- Strengths of the program-
- Potential first-in-class opportunity
- Broad application of CB2 can be explored in
indications such as Rheumatoid Arthritis,
Multiple Sclerosis, Atopic Dermatitis, ALS - Highly efficacious in pain models
26GRC 10693 Highly specific for CB2 over CB1
High efficacy in pain models
CB1 vs CB2 CB1 agonists (Narcotics such as
Morphine, Codeine) are well established
analgesics but are plagued by psychoactive side
effects while CB2 may be devoid of this side
effect
- In-Vivo Efficacy Model
- GRC 10693 High efficacy levels compared to
Gabapentin - Compound significantly reversed the mechanical
hyperalgesia in both acute and chronic dosing
GRC 10693 Highly Specific for CB2 over CB1
High Activity Levels in CB2 target
Thomson Database
27GRC 10693 Clinical Development Update
Clinical Development
- Glenmark is currently conducting a Phase I
clinical study in healthy volunteers in Europe.
This study is designed to investigate the safety,
tolerability and pharmacokinetics of single and
multiple doses of GRC 10693. - The study will be conducted in approximately 80
subjects (6 cohorts of 8 subjects each in single
ascending doses and 4 cohorts on 8 subjects each
in multiple ascending doses). - As of 4th Nov, 2008, the first 4 cohorts of 8
healthy volunteers each (total of 32), have
received single doses ranging from 1mg to 90mg.
All of these doses have been well tolerated with
no significant cardiac effects (e.g. on heart
rate, or ECG abnormalities including QTc
interval) or CNS effects
28Program GBR 500 - Monoclonal Antibody mAb
- Strengths of the program-
- Novel mechanism with very broad anti-inflammatory
potential - First-in-class opportunity no other mAb against
same target - Potential to expand indications to oncology -
First Xenograft data provides results comparable
to gold-standard antibodies
29GBR 500 Broad Anti-inflammatory Potential
- Broad Anti-inflammatory Potential-
- Integrins regulate movement of leukocytes and
cytokine release - Alpha2Beta1 integrin antagonist (GBR 500) targets
integrin receptors and is an effective therapy
for various inflammatory disorders - These disease modifier agents target initiation
of disease
GBR 500
30Program GRC 15300
31 GRC 15300 Strengths of the Program
- Strengths of the program-
- Glenmark has one of the most in-depth research
programs in TRP channels globally - Potential first-in-class for TRPV3
- TRPV3 target acts in different temperature range
devoid of hyperthermia issues. This is contrary
to some of the TRPV1 antagonists, currently in
development, which may cause elevated body
temperatures on inhibition - Highly efficacious as compared to current Gold
standard molecules (Pregabalin, Gabapentin), as
seen in animal models - Non-habit forming class , better option for
chronic pain therapy
32GRC 15300 first-in-class opportunity in various
pain conditions
First-in-class Opportunity Some TRPV3 Ligands
Patented But None in Clinical Development
High Efficacy observed in Animal Models of
Neuropathic Pain
33Program GBR 600 - Monoclonal Antibody mAb
- Strengths of the program-
- Novel anti-thrombosis monoclonal antibody
- High efficacy demonstrated by high potency as
shown in in vivo primate model large
therapeutic window - Very low/ negligible bleeding liability that is a
common short-coming of molecules in this class
34GBR 600 Potentially high efficacy safety
Blood Loss Liability minimised with GBR 600 in
non-human primate model
- Efficacy Safety of GBR 600
- Bleeding was self limiting and not severe
- GBR 600 shows high potency and insignificant
bleeding in rodent and non-human primate models.
Estimated Global Sales 2007 Plavix USD 16
Bn ReoPro USD 540 Mn Medtrack/ Co. Annual
Reports
(ReoPro)
(Plavix)
Legend Comparison of relative blood loss volume
at 2 x effective dose compared to treatment with
vehicle
35Program GRC 9332
36GPL Specialty Business
37Rest Of The World (RoW) The Year Till Date
Russia CIS Building on stronghold in Russia
while increasing focus on 3 major CIS countries
LatAm -Continuing intense activity in the sphere
of new market entry
India Sharpening focus through divisional
approach
Africa-ME Making inroads into Middle East
markets while driving growth through brands in
Africa
Asia Pacific Rapid growth in invest countries
while building base in new entry markets
38India Formulations The year till date going
forward
- Revenue increase of 16.8 over H1 FY 2008
- Steady growth driven by new brand introductions
and successful strategy of divisionalisation - According to ORG Sep 2008, Glenmark registered a
value growth of 17.7 in the Indian pharma
market while market grew at 11.1 - Launched 15 new products in H1.
- Major launches include Onabet (Sertaconazole
first time launch), Deriva CMS (Adapalene
Clindamycin using microsphere technology), Hair4U
(Aminexil Minoxidil first time launch) - Telma (Telmisartan) entered the top 300 brands of
the industry
H1 Highlights
- On track to meet/ beat guidance of 13 growth in
revenues in FY09 - Launch gt 20 new products overall in FY2009
- Maintain leadership in dermatology and
consolidate position in other therapies
Going Forward FY09
39India Formulations Revenues and Growth Drivers
- India Growth Drivers
- FY09- Increasing share of Dermatology market
through multiple divisions - Innovative product launches (Novel combinations,
NDDS) - Critical Care segment entry through new division
Critica - FY10- Dermatology, Cardiology Diabetology
segments will fuel the growth - Niche product launches in Oncology division
Onkos - Significant value addition from Critica
Revenues in USD Mn
Projected
40Russia-CIS, Africa-Middle East Asia-Pacific
(Semi Regulated Markets) The year till date
going forward
- H1 revenues from Asia, Africa and CIS region
were USD 25.72 Mn registering growth of 10.8
over H1 2008 - The company filed 17 products and received 84
product approvals in SRM region - RussiaCIS - Russian market saw launches of 4
dermatological products in the acne and
anti-inflammatory therapeutic area - Glenmarks Nasik plant successfully
passed a GMP audit of the Ukraine Ministry of
Health - Africa-ME Operations initiated in Egypt and UAE
- Amongst important launches were Oncology range
in Kenya, several new launches in Nigeria
Mauritius - Asia-Pac Strong growth numbers from subsidiaries
in Malaysia Philippines - Entry into hospital segment in Vietnam and
Malaysia -
H1 Highlights
- The company is on track to achieve growth of over
20 in Asia, over 35 in Africa and over 70 in
Russia-CIS region in FY09 - Operations will be strengthened , teams
established and product strategies firmed in new
markets such as China, Australia, Thailand,
Egypt, UAE and CIS countries - Company will actively pursue brand acquisitions
in invest markets
Going Forward FY09
40
41Asia-Pacific , Africa-Middle East
Russia-CIS(Semi Regulated Markets) Revenues and
Growth Drivers
Revenues in USD Mn
- Asia Pacific Growth Drivers
- FY09- Healthy growth numbers from subsidiaries
in Malaysia, Philippines - Entry into large hospital segments in mkts.
Including Vietnam, Malaysia - FY10- Inorganic growth plans in Thailand,
Australia China
- Africa-ME Growth Drivers
-
- FY09- New product range launches in Nigeria
- Onco range launch in Kenya
- rest organic growth
- FY10- Inorganic growth in Egypt
- New product growth in Nigeria
- Russia CIS Growth Drivers
- FY09- Growth from existing brands Ascoril line
extensions - Derma portfolio launches
- FY10- High growth from CIS mkts.
- High returns on Derma portfolio
- in-licensed products
USD 15-25 Mn sales are expected to come from
inorganic growth
41
42Latin America - The year till date going
forward
- Glenmarks revenues from Latin American
operations registered an overall decline of 9.4
over H1 2008. Mainly attributed to tender orders
that were executed in 1st qtr of last financial
year. - As reported by IMS Sept. 08 , the Brazilian
subsidiary has shown excellent growth in market
of 90 over H1 2008 - IMS Rankings in focus segments have gone up
rapidly Dermatology 50th in sept.07 to 21st
in sept. 08 Endocrinology 85th in sept.07 to
22nd in sept.08 - Overall 21 products were filed and 13 product
approvals received in H1 2009 - Amongst several launches , the company has added
Quality-of-Life products like Radiaplex
Oramedic (AloeVera oral rinse) to its oncology
portfolio - Company initiated operations in Mexico
H1 Highlights
- Operations will be strengthened , teams
established and product strategies firmed in new
markets such as Mexico, Venezuela Peru - On course to meeting guidance of USD 60 Mn in
FY09
Going Forward FY09
42
42
43Latin America - Revenues and Growth Drivers
Revenues in USD Mn
- LatAm
- FY09- Organic growth in Brazil and initial
contribution from Peru, Venezuela - FY10- Niche product launches in Brazil New
Market growth in Peru, Venezuela Mexico
Projected
43
43
44The year till date and going forward European
Union (EU) -
United States (US)
- Glenmarks EU operations registered growth of
160.3 over H1 2008 (mainly attributed to brand
acquisitions in Poland) - Established new company in Poland and acquired a
portfolio of 7 branded products from Actavis - Established subsidiary in Romania, recruited
sales team and subsequently launched Aflen
(Triflusal) in the cardiovascular space - Glenmark manufacturing site in Czech Republic
being developed as EU centre for packaging and
distribution and 1st own product Topiramate
released for launch across EU
H1 Highlights
- Glenmark is actively looking at inorganic entry
options into the US Specialty market - The company is evaluating targets with
proprietary brands and a primary care sales force
- Central Eastern European regions will be major
growth driver - Focus will be on building infrastructure and
front ends in new markets such as Romania, Poland
Bulgaria - Company plans to launch atleast 5 products in EU
in FY2009 - GPEL (Glenmark Pharmaceuticals Europe Ltd.) will
shift to Prague in near future
Going Forward
Revenues in USD Mn
Projected
44
44
44
45GPL Operations H1 Highlights
- Completed capacity expansion at formulations
plant at Nashik ,India - Commenced site activities at
- Biologics API plant at Aurangabad, India
- New formulation plant at Brazil
- Acquired land from SEZ at Indore, India Basic
engineering for building over ten lines across
five dosage forms underway - Initiated design of
- New NCE API plant
- Capacity expansion at Baddi, India
- Capacity expansion at Czech plant
- Functional upgrade in SAP across all India sites
initiated roll-out of SAP to Latin American
operations
H1 Highlights
46GPL Operations Near Future Expansion Plans
47GPL - Financials Projections
Projected
Gr. 25
Profits In mn
93
123
157
48GGL Span of Operations
GGL
49GGL Rapid progression towards attaining its
vision of becoming a Global Integrated Generic
API Leader
- Active Pharmaceutical Ingredients
- Continued expansion of API capabilities to
support both internal and 3rd party dosage forms - Focus on difficult to develop molecules
- Continued filings of DMFs across geographies
- European Union
- In process of establishing distribution
front-ends in Western Europe - Licensing distribution partnerships continue to
be expanded - Focus on steady mix of unique niche EU Dossiers
- North America/ US
- Rapidly increasing product portfolio market
share - Focus on niche difficult categories
- Thrust on vertical integration for most products
- Expanding our strong relationship with the trade
(chains/wholesalers/distributors)
- Oncology
- Glenmark Argentina to continue as the hub of the
global oncology business - Currently expanding presence across LatAm RoW
markets - Focus on developing portfolio for regulated
markets initiate filings in regulated markets
50US Formulations The year till date and going
forward
- Continued excellent performance by Glenmark
Generics Inc. USA. The subsidiary posted H1
revenues of over USD 85.90 Mn registering a
growth of 124.2 over H12008 - Filed 10 ANDAs with the US FDA and received 5
approvals during H1 2009. GGI currently has over
40 ANDAs in various stages of approval with the
US FDA - Among the four first- to-file PIV applications
submitted, currently in litigation on two of the
products - 5 product launches - Nystatin Oral Suspension,
Oxycodone Oral Solution, Metformin HCl Tablets,
Mometasone Cream Mometasone Lotion - Portfolio of over 35 generic products, currently
on the US market ,mix of oral solids/oral
liquids/semisolids, focused on niche categories
of controlled substances, modified release and
dermatology
H1 Highlights
- Company is on course to launch at least 20
products in this financial year and complete
filings of over 30 ANDAs - Maintain focus on niche categories and continue
to evaluate entry into 1-2 new niche categories
in FY09 - Manage product portfolio to include a judicious
mix of PI, PII, PIII and PIV filings
Going Forward- FY09
Revenues in USD Mn
Projected
50
50
50
51GGL Expanding Presence in the US Generics
Market
Plans to participate in gt 50 of market ,in focus
therapy areas, by 2014
IMS Database MAT June 2008
52GGL Stepping-up ANDA filings in focus therapy
areas
ANDA Filings Update
FTF ANDA Ongoing Litigation
53EU Formulations - The year till date and going
forward
- Glenmark Generics Europe Ltd (GGEL) achieved a
major milestone by launching its first product in
Western Europe via initiation of sales of
Perindopril tablets in the UK. - Filed 8 Marketing Authorization Applications
(MAAs) till date and has received approvals for
2 Glenmark products in several EU markets in H1
FY09. - Regulatory submission slots were procured with
various EU regulatory agencies to facilitate a
further 8 filings in this financial year - Culmination of several licensing and supply deals
with European generic companies high interest
from both pan European and local European
partners to participate in our unique portfolio - Plans initiated to establish Glenmarks own
presence in selected key markets
H1 Highlights
- Western Europe region to be the main growth
driver - Product launches planned in more European markets
in H2 FY2009 - On track to make eight product submissions via
the DCP / MRP / Centralized routes in H2 FY2009 - Continuing focus on a differentiated product
portfolio - 2 submissions out of the 8 planned
are for Dermatology products. - On course to conclude several more out-licensing
and supply agreements with European generic
companies. - Continue build out of a finished dosage pipeline
with backward integration into APIs
Going Forward FY09
Revenues in USD Mn
Projected
53
53
53
54Oncology (Argentina)- The year till date and
going forward
- Oncology business posted growth of over 35.9
with revenues of USD 5 Mn, as against H1 2008 - Glenmark Generics SA filed 4 dossiers 31 Extra
company dossiers - Launched products in Ecuador, Venezuela, Yemen,
Paraguay -
H1 Highlights
Extra-company excludes Brazil, Trinidad
Tobago, ROW and any other intra-company
operations
- On track to achieve FY2009 target of 5 filings
and 8 approvals in Argentina and 64 filings and
50 launches (extra company) - 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 - On course to start the filing of products into
the regulated market in late FY09/early FY10
Going Forward
Revenues in USD Mn
Projected
54
54
54
55 Active Pharmaceutical Ingredients (API)
The year till date and going ahead
- Global API business posted growth of over 14.5
with revenues of USD 22 Mn, compared to H1 2008 - Initiated business in South Africa Egypt
- Company has filed 32 DMFs till date. Additionally
4 European DMFs filed in H1 - Successful completion of USFDA audit for
Ankleshwar API facility, India - 5 Products DMF process validation batches
completed -
H1 Highlights
- Continue efforts to become the preferred 3rd
party API supplier to the generic industry and
support high value First to File opportunities. - Continue to support finished dosage pipeline with
backward integration into APIs including our
niche segments - On course to file atleast 10 DMFs in current
financial year - Targets entry into new markets in Africa region
- Focused on development of over 15 APIs annually
to provide cost and timing advantage to
complement US and Europe generic filings
Going Forward FY09
Revenues in USD Mn
Projected
55
55
55
56GGL Operations H1 Highlights
Goa plant (India) increased capacity by 33 .
Added 4th oral solids line ANVISA audit and
approval in Goa Formulations Facility,
India Successful US FDA audit Goa
Formulations Facility, India Successful US FDA
audit - Ankleshwar API facility,
India Successful US FDA audit Mahape
Bio-Analytical facility, India Expansion at
Ankleshwar API plant -Plant 9 operational with
3KL reaction capacity.
H1 Highlights
56
56
56
57GGL Operations Near Future Expansion Plans
58GGL - Financials Projections
429
297
10
196
4
Gr. 44
Gr. 52
Profits In mn
64
87
125
59Glenmark Consolidated Financials
932
Projected
Revenues In USD Mn
673
499
Gr. 38
Gr. 35
In USD Mn
Basic EPS Doesnt consider impact of dilution
on account of ESOps and convertible bonds In
mn (Assumed exchange rate of 40.28 INR/USD P/E
based on Share Price of Rs. 303 as on 6th Nov 08
60For queries on Glenmark Pharmaceuticals
Ltd, please contact media_at_glenmarkpharma.com For
queries on Glenmark Generics Ltd, please
contact connect_at_glenmark-generics.com