Our Vision
“To emerge as a leading, research-
based, global,
integrated pharmaceutical
company ”
Our Values
2
Safe Harbour Statement
This presentation has been prepared by Glenmark.
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 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.
Glenmark
Glenmark Pharmaceuticals Limited (GPL) – Specialty
Business
Glenmark Generics Limited (GGL- wholly owned sub. of
GPL) – Generics Business
Glenmark – Consolidated Financials and Projections
Agenda
4
Glenmark has made rapid strides towards achievement of vision
Pre 2000 Glenmark
Sales< $ 20 mn
Domestic focus
<5% of exports
Researchbased
Global
Integrated
• Research efforts in Small molecules, Biologics and Generics
• 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
• Mfg facilities in 4 countries
• Operates in over 85 countries
• Front ends in US, India, Brazil and other markets worldwide
• 3 API plants
• 8 finished dosage plants
• 3 research facilities
Glenmark today
Revenues : $ 499 mn
India based MNC
>60% of exports
Glenmark
5
Glenmark - Global Footprint
1 API Plant, Gujarat, India
3 Dosage Plants, Goa, India
1 Dosage Plant - Brazil
1 Dosage Plant –
Czech Republic
1 Dosage Plant, HP, India
1 Dosage Plant, Maharashtra, India
R&D for NCEs, India
R&D for Generics, India
R&D for Biologics, Switzerland
Glenmark Generics Ltd., US
Glenmark Generics SA,
Argentina
Medicamenta, Czech Republic
Glenmark Farmacetica Ltda.,
Brazil2 API Plants,
Maharashtra,India
Glenmark Generics Europe Limited,
London, UK
Glenmark Pharma Europe Limited,
London, UK
Several other subsidiaries and representative offices exist across the world
Bowter Bartlett South Arica
Glenmark India
1 Dosage Plant - Argentina
6
Glenmark - Financials
Note : 1. Average conversion rate for FY 2006-07 of Rs. 44.14 / USD 1.002. Average conversion rate for FY 2007-08 of Rs. 40.28 / USD 1.00
In $ mn
FY 20071 (ending Mar’07)
FY 20082
(ending Mar’08)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
7
283171
499
0
100
200
300
400
500
600
FY 06 FY 07 FY 08
0%
10%
20%
30%
40%
50%
60%
70%
Revenues
Growth
Glenmark has shown consistent robust growth across businesses
Revenues in $ mn
ending Mar’06 ending Mar’07 ending Mar’08
Glenmark
Note : 1. Average conversion rate for FY 2005-06 of Rs. 44.28 / USD 1.002. Average conversion rate for FY 2006-07 of Rs. 44.14 / USD 1.003. Average conversion rate for FY 2007-08 of Rs. 40.28 / USD 1.00
1 2 3
8
Glenmark Generics Ltd
(GGL)
Glenmark Pharmaceuticals Ltd
(GPL)
Glenmark is divided into two main businesses with different business focus
LeadershipMD and CEO:
Glenn Saldanha
Chairman:
Glenn Saldanha
CEO:
Terry Coughlin
Vision Global end to end Specialty Company Global integrated Generic & API leader
Wholly owned
subsidiary
*To be listed in India during FY 2009
Specialty/Proprietary Generics
Glenmark
Glenmark
Glenmark Pharmaceuticals Limited (GPL) – Specialty
Business
Glenmark Generics Limited (GGL- wholly owned sub. of
GPL) – Generics Business
Glenmark – Consolidated Financials and Projections
Agenda
10
Vision for Glenmark Pharmaceuticals Limited
Product PortfolioLaunch two proprietary drugsBuild late stage pipeline
Market PresenceProprietary product front ends in US, key ROW & European markets
Market PositioningInnovation led companyDifferentiated branded generic company
Invest in building brands
Target 2015
Expand into new territories
Build differentiated product franchise
“Global end-to-end Specialty Company”
Licensing
Strategy
Transition into a proprietary product marketing company
11
Global Therapeutic Focus
Metabolic Disorders
Inflammation
Innovative R&DTherapeutic Focus
Pain, Respiratory (Asthma/COPD), Rheumatoid Arthritis
Diabetes (Type II),Obesity
DermatologyPsoriasis, Pruritus, Atopic Dermatitis
Glenmark Pharmaceuticals Limited: Specialty Business
12
NCE EuropeUS
(Inorganic entry)
ROW(Rest of the
World)
Finished Dosage Formulations
Biologics (Swiss)
R&D
Business Unit Structure
Glenmark Pharmaceuticals Ltd. (GPL)
Glenmark Pharmaceuticals Limited: Specialty Business
Research and Development (R&D)
14
Glenmark’s R&D Efforts – both small molecules and biologics
New Chemical Entity (NCE) Research
Over 300 scientists
Based in Mumbai, India
New Biological Entity (NBE) Research
Over 55 scientists
Based in Switzerland
Pipeline of 13 molecules
8 NCEs and 5 NBEs
Glenmark Pharmaceuticals Limited: Specialty Business
15
Research Pipeline: 13 molecules at various stages of development
Screening
GRC 4039
DPP-IV, PDE IV, CB2, TRPV1, SCD1, VLA2, TRPV3 etc.
Oglemilast (1)
Melogliptin (2)
GRC 6211 (3)
GRC 10693
GRC 9332
GBR 600 *
GBR 500 *Three undisclosed NBEs
(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.
Discovery Pre-clinical Phase I Phase IIb
World class targets
13 research molecules
One undisclosed NCE
Glenmark Pharmaceuticals Limited: Specialty Business
GRC 17173
* NBE
16
Progress on Research Pipeline
Compound Primary Indications Target Target Launch
Pre-clinicals
Phase I Phase II Phase III Approval
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-ά + 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
undisclosed
2014
One NCE and three biologics are at the discovery stage and are expected to enter the clinics during FY 2010/2011
Glenmark Pharmaceuticals Limited: Specialty Business
17
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
Glenmark Pharmaceuticals Limited: Specialty Business
18
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
Glenmark Pharmaceuticals Limited: Specialty Business
19
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 Oct’06; 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
Glenmark Pharmaceuticals Limited: Specialty Business
20
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
Glenmark Pharmaceuticals Limited: Specialty Business
21
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
Glenmark Pharmaceuticals Limited: Specialty Business
22
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
Glenmark Pharmaceuticals Limited: Specialty Business
23
GRC 17173 [Target: Transient Receptor Potential Vanilloid (TRPV)3 Antagonist]
Glenmark Pharmaceuticals Limited: Specialty Business
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
24
GBR 500 Target: (a) Alpha2 βeta1 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
Glenmark Pharmaceuticals Limited: Specialty Business
25
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
Glenmark Pharmaceuticals Limited: Specialty Business
GPL- Specialty Business
RoW, Europe and US
ROWUS
(inorganic route)
Europe(80*)
India(2000*)
Latin America(200*)
Asia(200*)
*Sales force strength
Africa(160*)
CIS(300*)
27
Glenmark’s strategy for future growth in RoW markets
Latin America
Africa
CIS
Asia
• Focus on Top-15 markets
• High thrust on building ‘branded business’ which currently accounts for over 85%
• Launch of novel ‘differentiated’ branded generics for getting a significant competitive edge
• Capitalize on ‘local know-how’ (country heads in over 20 markets)
• Driving the business through qualified, experienced and dedicated ‘field force’
• Focus on sustainable doctor centric ‘prescription’ based model for building brands
• Leverage on efficient and quality ‘distribution’ network for better market penetration
• Focus on Top-15 markets
• High thrust on building ‘branded business’ which currently accounts for over 85%
• Launch of novel ‘differentiated’ branded generics for getting a significant competitive edge
• Capitalize on ‘local know-how’ (country heads in over 20 markets)
• Driving the business through qualified, experienced and dedicated ‘field force’
• Focus on sustainable doctor centric ‘prescription’ based model for building brands
• Leverage on efficient and quality ‘distribution’ network for better market penetration
Str
ate
gy
Glenmark Pharmaceuticals Limited: Specialty Business
India
Australia
RoW Markets
India
29
India – Performance FY 2008
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
152
175
97
135
FY 2007 FY 2008 FY 2009 * FY 2010 *ending Mar’08ending Mar’07
Glenmark Pharmaceuticals Limited: Specialty Business
ending Mar’09 ending Mar’10
* Projected
Revenues in $ mn
Glenmark’spresence
Action PlanFY 2009
¤ Operates through 9 divisions
¤ Sales force > 2000 medical representatives
¤ Markets over 250 products in India
¤ Register growth of over 10 %
¤ Launch > 20 new products
¤ Maintain leadership in dermatology and consolidate position in other therapies
India – Action Plan
Glenmark Pharmaceuticals Limited: Specialty Business
RoW Markets
Latin America (LatAm)BrazilVenezuela Mexico PeruChileBoliviaColumbiaEcuadorCaribbean countries
32
LatAm – Performance FY 2008
Highlights
¤ 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
60
80
48
26
FY 2007 FY 2008 FY 2009 * FY 2010 *ending Mar’08ending Mar’07
Glenmark Pharmaceuticals Limited: Specialty Business
ending Mar’09 ending Mar’10
* Projected
Revenues in $ mn
33
Glenmark’s Presence
Action PlanFY 2009
¤ LatAm Pharma Market : >$ 35 bn
¤ 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 %
¤ File for 80 product approvals and launch 60 products
¤ Plans to enter Mexico during FY 2009
LatAm – Action Plan
FY 2009(ending Mar’09)
FY 2010(ending Mar’10)
Peru3%
Venezuela
3%
Brazil80%
Others9%
Carribean
5%
Peru3%
Venezuela
4%
Brazil75%
Others7%
Carribean
5%
Mexico6%
Glenmark Pharmaceuticals Limited: Specialty Business
Revenue contribution *
* Projected
RoW Markets
Australasia (excluding India, CIS & Japan)MalaysiaPhilippinesIndonesiaChinaSouth KoreaMyanmar VietnamSri LankaCambodiaAustralia
35
Australasia– Performance FY 2008
32
1311
FY 2008 FY 2009 * FY 2010 *ending Mar’08
Highlights
¤ Launched over 60 products
¤ Filed for over 100 product approvals
¤ Top-10 brands contribute over 65% of the business
Glenmark Pharmaceuticals Limited: Specialty Business
ending Mar’09 ending Mar’10
* Projected
Revenues in $ mn
36
Glenmark’sPresence
Action PlanFY 2009
¤ Australasia Pharma Market (excluding India, Japan, CIS) : >$ 55 bn
¤ China, Philippines, Malaysia, Indonesia, Australia are the key markets
¤ Registered over 400 branded generic products across Asian markets
¤ Recently entered Australia, China and Indonesia
¤ Strong sales force setup of 200 medical representatives
¤ Register growth of over 20 %
¤ File for 100 product approvals and launch 30 products
Australasia – Action Plan
FY 2009(ending Mar’09)
FY 2010(ending Mar’10)
Phillipines21%
Others55%
Malaysia24%
Phillipines18%
Others18%
Malaysia19%
Indonesia15%
China15%
Australia15%
Glenmark Pharmaceuticals Limited: Specialty Business
Revenue contribution *
* Projected
RoW Markets
AfricaSouth AfricaNigeriaKenya SudanEgyptTanzaniaYemenIvory Coast Zambia Mauritius Uganda Cameroon GhanaIncludes middle east countries
38
Africa– Performance FY 2008
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
42
25
18
FY 2008 FY 2009 * FY 2010 *ending Mar’08
Glenmark Pharmaceuticals Limited: Specialty Business
ending Mar’09 ending Mar’10
* Projected
Revenues in $ mn
39
Glenmark’s Presence
Action PlanFY 2009
¤ Africa Pharma Market : >$ 10 bn
¤ South Africa, Nigeria, Sudan, Kenya, Egypt are key markets
¤ 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 %
¤ File for 75 products and launch 45 products
¤ Plans to enter Algeria, UAE
¤ Look for brand acquisition opportunities for entry/growth
Africa – Action Plan
Kenya14%
Others41%
South Africa20%
Nigeria11%
Sudan14%
Kenya12%
Others24%
South Africa25%
Sudan12%
Nigeria15%
Egypt12%
FY 2009(ending Mar’09)
FY 2010(ending Mar’10)
Glenmark Pharmaceuticals Limited: Specialty Business
Revenue contribution *
* Projected
RoW Markets
CISRussia Ukraine Uzbekistan
Kazakhstan
41
CIS – Performance FY 2008
Highlights
¤ Company launched 40 products
¤ Filed for over 30 product approvals across CIS
¤ Top-5 brands contribute over 90% of CIS business
¤ Glenmark’s brand Ascoril is the no 1 brand in the cough expectorant market in Russia
66
38
22
FY 2008 FY 2009 * FY 2010 *ending Mar’08
Glenmark Pharmaceuticals Limited: Specialty Business
ending Mar’09 ending Mar’10
* Projected
Revenues in $ mn
42
Glenmark’s Presence
Action PlanFY 2009
¤ CIS Pharma Market : >$ 15 bn
¤ 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 %
¤ File for 25 product approvals
¤ Launch 25 products
CIS – Action Plan
FY 2009(ending Mar’09)
FY 2010(ending Mar’10)
Revenue contribution *
Ukraine4%
Uzbekistan3%
Russia92%
Kazakhstan1%
Glenmark Pharmaceuticals Limited: Specialty Business
* Projected
Ukraine4%
Uzbekistan4%
Russia91%
Kazakhstan1%
Europe
44
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
9
40
20
FY 2008 FY 2009 * FY 2010 *
ending Mar’08
Glenmark Pharmaceuticals Limited: Specialty Business
ending Mar’09 ending Mar’10
* Projected
Revenues in $ mn
45
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 Glenmark’s proprietary
medications that would reach the market in the next 3-5 years
Glenmark Pharmaceuticals Limited: Specialty Business
46
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
¤ Glenmark’s 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 -
Glenmark Pharmaceuticals Limited: Specialty Business
47
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
Romania28%
Bulgaria3%
Czech69%
Romania24%
Bulgaria12% Czech
50%
New14%
FY 2009 FY 2010ending Mar’09 ending Mar’10
Glenmark Pharmaceuticals Limited: Specialty Business
* Projected
Revenue contribution *
48
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
Glenmark Pharmaceuticals Limited: Specialty Business
49
Infrastructure and facilities
Location Production Lines Regulatory Approvals
R&D Facility, Navi Mumbai
NCE Research and Process DevelopmentNA
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 semi-regulated 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
Glenmark Pharmaceuticals Limited: Specialty Business
50
60
8018
25
42
11
13
32
22
38
66
9
20
40
60
69
69
135 152 175
48
FY 2008 FY 2009 FY 2010
NCE
Europe
CIS
Australasia
Africa
LatAm
India
RevenuesIn $ mn*
Business Mix
CAGR ~29 %
CAGR ~ 30%
* In $ mn (Assumed exchange rate of ~40.28 INR/USD for FY08 and ~ 40 INR/USD for FY09 and FY10)
ProfitsIn $ mn 93 123 157
377 504
(ending Mar 08) (ending Mar 09) (ending Mar 10)
Financials and Projections – Organic growth only
303
Glenmark Pharmaceuticals Limited: Specialty Business
51
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
Glenmark Pharmaceuticals Limited: Specialty Business
Glenmark Generics Ltd. (GGL)
Generics Business
Glenmark
Glenmark Pharmaceuticals Limited (GPL) – Specialty
Business
Glenmark Generics Limited (GGL- wholly owned sub. of
GPL) – Generics Business
Glenmark – Consolidated Financials and Projections
Agenda
54
Safe Harbour Statement
This presentation has been prepared by Glenmark.
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 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.
55
Vision for Glenmark Generics Limited (GGL)
Product Portfolio170 generics on the US market70 generic dossiers for EU marketsOver 50 % of revenues from niches
Market PresencePresence in Japan, South Africa & other generic markets Front ends in Japan and key EU markets along with NA
Market PositioningKey Generic PlayerPreferred supplier of APIs
Increase Geographical Reach
Target 2015
Expand Niche Product Portfolio
“Global Integrated Generic & API leader”
Vertical Integration
Strategy
56
APIEuropeNorth
America Argentina(Oncology)
Finished Dosage Formulations API
Glenmark Generics Ltd. - Business Unit Structure
Glenmark Generics Ltd. (GGL)
North America
58
North America – Performance FY 2008
50
140
207
303
FY 2007 FY 2008 FY 2009 * FY 2010 *
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
ending Mar’07 ending Mar’08
Glenmark Generics Limited: Generics Business
ending Mar’09 ending Mar’10
* Projected
Revenues in $ mn
59
North America: The US Market
2022
30
2009 2010 2011Values in $ Bn
The Market¤ $ 286 bn
¤ 65% generics by volume represent 20% of the
market by value
Market Characteristics
¤ Political climate increasingly supportive of
generics to lower healthcare costs
¤ Increasing competition in “me-too” generics
¤ Authorized generics and shared exclusivities
reducing upsides from 180-day exclusivities
Opportunities
¤ Customers prefer vertically integrated companies
with long term plan
¤ In the next 3-5 years, drugs worth $ 60-70 Bn are
going off-patent
Glenmark Generics Limited: Generics Business
60
¤ Revenues crossed $ 100 mn in first three years of
operations
¤ Received 180 day exclusivity for Oxcarbazepine
¤ Filed PIVs (FTF opportunities) for Zetia®, Tarka®,
Strattera® & Crestor®
¤ 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
North America – Glenmark’s rise as a generic player
6
13
28
FY 2006 FY 2007 FY 2008
Background
¤ GGI, USA (Glenmark Generics Inc.) launched the
first product in Jan 2005
¤ Registered net revenues of $ 140 mn in FY 2008
Product Portfolio
Highlights
ending Mar’07 ending Mar’08ending Mar’06
Glenmark Generics Limited: Generics Business
61
ANDAs filed / marketed Till FY FY FY Total Filings
(Includes partner filings) 2008 2009 2010
Dermatology 10 8 8 26
Controlled Substance 4 4 4 12
Modified Release 6 10 10 26
Hormones 3 4 5 12
Oncology - 4 5 9
First to File (P-IVs) 6 3 3 12
Immediate Release 32 4 4 40
Total 61 37 39 137
US: Plan for ANDA Filings
Glenmark Generics Limited: Generics Business
US Product Portfolio: Dermatology
¤ Total Topical Derma Market is $4.3 bn of which over
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
¤ 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]
The Market
GGL’s Portfolio
1018
26
Till FY2008
FY2009
FY2010
Glenmark Generics Limited: Generics Business
62ending Mar’08 ending Mar’09 ending Mar’10
Fillings (Cumulative)
¤ Total CS Market is valued over $12 bn
¤ Key generic players include: Mallinckrodt, Watson, Endo
¤ High barriers to entry:
¤ DEA licensures required
¤ Limitations on importing controlled substances from foreign
countries
¤ Higher margins on controlled substance products due to
limited players
US Product Portfolio: Controlled Substances (CS)
¤ Controlled substance portfolio (current market
size $ 200 mn)
¤ 3 controlled substances already launched
¤ 7 additional products anticipated to be launched
within next 3 years
The Market
GGL’s Portfolio
48
12
Till FY2008
FY2009
FY2010
Glenmark Generics Limited: Generics Business
63ending Mar’08 ending Mar’09 ending Mar’10
Fillings (Cumulative)
US Product Portfolio: Modified Release
¤ Total sales revenue for Modified Release oral solids is
over $22 bn
¤ 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
already filed [14 products anticipated (current market size
$1.6 bn) to be launched within next 3 years]
616
26
Till FY2008
FY2009
FY2010
The Market
GGL’s Portfolio
Glenmark Generics Limited: Generics Business
64
ending Mar’08 ending Mar’09 ending Mar’10
Fillings (Cumulative)
US Product Portfolio: Hormones
¤ Total Solid oral dosage Hormones Market is
approximately $5 bn
¤ Key generic players include: Barr & Watson
¤ Only Indian Company with India based hormones
portfolio [10 products anticipated (current market size $1
bn) to be launched within next 3 years]
¤ Higher margins on Hormones Products
¤ Limited players
¤ Dedicated facility required
¤ Higher cost of bio-studies
2
7
12
Till FY2008
FY2009
FY2010
The Market
GGL’s portfolio
Glenmark Generics Limited: Generics Business
65
ending Mar’08 ending Mar’09 ending Mar’10
Fillings (Cumulative)
US Product Portfolio: Oncology
¤ Total Oncology Market in the United States is over $10 bn
¤ Key generic players include: Teva Sicor, Ben-Venue &
Barr
¤ Portfolio includes a mix of 14 solid oral dosage and 13
injectable products (Total market size: >$ 7.5 bn)
¤ Higher margins on Oncology Products
¤ Limited players
¤ Dedicated facility required
The Market
GGL’s portfolio
0
4
9
Till FY2008
FY2009
FY2010
Glenmark Generics Limited: Generics Business
66
ending Mar’08 ending Mar’09 ending Mar’10
Fillings (Cumulative)
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/
VerapimilTarka® Sanofi-Aventis $ 95 mn
US Product Portfolio: FTF ANDA Ongoing Litigation
Glenmark Generics Limited: Generics Business
69
12
Till FY2008
FY2009
FY2010
ending Mar’08 ending Mar’09 ending Mar’10
Fillings (Cumulative)
67
68
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)
Glenmark Generics Limited: Generics Business
69
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
Glenmark Generics Limited: Generics Business
Europe
71
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
Market Characteristics
¤ To bring down the cost of publicly funded
healthcare is the main driver in promoting
generics
¤ Europe is characterized with each country
having different regulatory authorities and
distinct pricing/reimbursement policies
Opportunities
¤ Key markets with high generic penetration: UK,
Germany, Netherlands
¤ 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
Glenmark Generics Limited: Generics Business
72
¤ GGEL (Glenmark Generics Europe Ltd.) was established
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
¤ Portfolio of more than 30 EU CTD solid and semi-
solids dossiers at various stages of development
¤ Several supply deals are in place with leading
European generic players
Europe generics business is gearing up for future
Background
Product Portfolio
Glenmark Generics Limited: Generics Business
ending Mar’08 ending Mar’09 ending Mar’10
0.2
4
10
FY 2008 FY 2009 * FY 2010 *
Revenues in $ mn
* Projected
73
¤ 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
Glenmark Generics Limited: Generics Business
Europe: Strategy for future growth
74
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
5
15
25
Till FY 2008 FY 2009 FY 2010
Total MAA Filings (cumulative)
ending Mar’08 ending Mar’09 ending Mar’10
Glenmark Generics Limited: Generics Business
Oncology Business
76
Oncology market
Market Size¤ Total Market Size >$ 30 bn
¤ Generic market worldwide > $ 8 bn
Market Characteristics
¤ Lesser competition because of entry barriers¤ Difficult to develop molecules
¤ Specially designed/dedicated manufacturing facilities
¤ Better operating margins due to lower price erosion
¤ Longer product life cycle as older therapies continue to co-exist with newer ones
Opportunities¤ 95 % of classic chemotherapy products are not
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
Glenmark Generics Limited: Generics Business
77
¤ Glenmark acquired the Argentinean marketing company
Glenmark Generics S.A. (erstwhile Servycal S.A.) with a focused
oncology 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
Oncology generics business
Background
Product Portfolio
Glenmark Generics Limited: Generics Business
6
8
15
25
FY 2007 FY 2008 FY 2009 * FY 2010 *ending Mar’07 ending Mar’08 ending Mar’09 ending Mar’10
Revenues in $ mn
* Projected
78
Oncology Business: Strategy for future growth
Use Argentina as a hub for spreading the
oncology business
Increase coverage for cancer
therapy products
¤ Use Argentina as a hub to spread 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
¤ Expansion of product portfolio to cater to 95%
Cancer therapy products
Glenmark Generics Limited: Generics Business
79
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
Glenmark Generics Limited: Generics Business
310
405
515
Till FY 2008 FY 2009 FY 2010ending Mar’08 ending Mar’09 ending Mar’10
Total DossierFillings (Cumulative)
Active Pharmaceutical Ingredients (API) Business
81
The Global API Market
Market Size¤ >$ 75 bn
¤ Growth >10% (2005)
Market Characteristics
Opportunities
¤ Large no of products set to go off-patent in the next
3-5 years
¤ Many of the other historical less-regulated markets
are quickly shifting towards stricter regulations
limiting competition and opportunities for
established players like Glenmark
¤ Increased consolidation in generic pharmaceutical
industry
¤ More focus on higher value creating opportunities
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
Glenmark Generics Limited: Generics Business
82
¤ API business spans across 80 countries including
regulated markets like US and Europe
¤ > 50% of the revenues is from exports
¤ Filed over 30 USDMFs till date
¤ Filed several Canadian DMFs, EDMFs and
CEPs/CoSs
API Business
Background
Product Portfolio
Highlights
¤ Registered growth of over 45%
¤ Exports contribute over 50% of the revenues
¤ Initiated commercial supplies to various customers
Glenmark Generics Limited: Generics Business
30
48
70
90
FY 2007 FY 2008 FY 2009 * FY 2010 *ending Mar’08ending Mar’07 ending Mar’09 ending Mar’10
Sales in $ mn
* Projected
83
API Business: Drivers for future growth
Expand product portfolio and market presence
¤ 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 IP¤ Focus on difficult to develop molecules
and generating IP around molecules
Continue to be a preferred 3rd party
API supplier
¤ Partner with generic companies to capture first and alternate source opportunities¤ Establish close relationship with major generic players globally to capture high end opportunities
Investments to ramp up infrastructure
¤ Invest in building infrastructure in order to
cater to increased demand and growth
Glenmark Generics Limited: Generics Business
84
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
Glenmark Generics Limited: Generics Business
US DMFFillings
Till FY 2008 FY 2009 FY 2010 Total Filings
31 18 18 67
ending Mar’08 ending Mar’09 ending Mar’10
85
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 Local FDA GMP approved
Mohol, India
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
Glenmark Generics Limited: Generics Business
86
70
90
8
15
25
313
211
140
48
FY 2008 FY 2009 FY 2010
Argentina
API
US and EU generics
RevenuesIn $ mn*
Business Mix
CAGR ~48 %
CAGR ~ 39%ProfitsIn $ mn 64 87 125
196 296 428
(ending Mar 08) (ending Mar 09) (ending Mar 10)
Financials and Projections – Organic growth only
Glenmark Generics Limited: Generics Business
* In $ mn (Assumed exchange rate of ~40.28 INR/USD for FY08 and ~ 40 INR/USD for FY09 and FY10)
87
Summary of key objectives for FY 09
Glenmark Generics Limited: Generics Business
¤ 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
Glenmark
Glenmark Pharmaceuticals Limited (GPL) – Specialty Business
Glenmark Generics Limited (GGL- wholly owned sub. of GPL) –
Generics Business
Glenmark – Consolidated Financials and Projections
Agenda
89
377
504
428296
196
303
FY 2008 FY 2009 FY 2010
Specialty
Generics
Consolidated Financials and Projections
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
(ending Mar 08) (ending Mar 09) (ending Mar 10)
Glenmark
* In $ mn (Assumed exchange rate of ~40.28 INR/USD for FY08 and ~ 40 INR/USD for FY09 and FY10)
90
Thank you