Transcript Slide 1

Our Vision
“To emerge as a leading,
research-based,
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 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.
2
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
• 13 new molecules under
development
• Over $ 110 mn of cash received
from out-licensing partners; Further
milestones worth over $ 600 mn
Pre 2000 Glenmark
Sales< $ 20 mn
Domestic focus
<5% of exports
• Over 5000 employees across 5
continents
• Mfg facilities in 4 countries
Global
• 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
4
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
5
Glenmark - Financials
Change
(ending Mar’07)
FY 20082
(ending Mar’08)
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
FY 20071
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
600
70%
499
60%
500
50%
400
40%
300
283
171
30%
Revenues
Growth
200
20%
100
10%
0
0%
FY 06
1
ending Mar’06
FY 07
2
ending Mar’07
3
FY 08
ending Mar’08
Revenues in $ mn
Note :
1.
2.
3.
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 focus
Specialty/Proprietary
Glenmark
Pharmaceuticals Ltd
(GPL)
Generics
Wholly
owned
subsidiary
Glenn Saldanha
Chairman:
Glenn Saldanha
CEO:
Terry Coughlin
Global end to end Specialty Company
Global integrated Generic & API leader
MD and CEO:
Leadership
Vision
Glenmark
Generics Ltd
(GGL)
*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
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
Glenmark’s 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
Pre-clinical
GRC 10693
Phase I
GRC 4039
GRC 9332
Three undisclosed
NBEs
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-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
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 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
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-TNFa) 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 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
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
Europe
(80*)
ROW
India
(2000*)
Latin America
(200*)
Asia
(200*)
US
(inorganic
route)
Africa
(160*)
CIS
(300*)
*Sales force strength
Glenmark Pharmaceuticals Limited: Specialty Business
Glenmark’s strategy for future growth in RoW markets
• 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
Asia
India
Africa
Latin
America
Australia
Strategy
CIS
• 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
27
RoW Markets
India
Glenmark Pharmaceuticals Limited: Specialty Business
India – Performance FY 2008
175
Revenues in $ mn
152
135
97
FY 2007
ending Mar’07
FY 2008
ending Mar’08
FY 2009 *
ending Mar’09
FY 2010 *
ending Mar’10
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
Glenmark’s
presence
¤ Operates through 9 divisions
¤ Sales force > 2000 medical representatives
¤ Markets over 250 products in India
Action Plan
FY 2009
¤ Register growth of over 10 %
¤ 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
80
Revenues in $ mn
60
48
26
FY 2007
ending Mar’07
FY 2008
ending Mar’08
FY 2009 *
ending Mar’09
FY 2010 *
ending Mar’10
Highlights
¤
¤
Registered growth of over 65%
¤
¤
Filed for over 100 product approvals in FY 2008
Launched 25 products across LatAm
Top-10 brands contribute over 75% of LatAm business
* Projected
32
Glenmark Pharmaceuticals Limited: Specialty Business
LatAm – Action Plan
¤ LatAm Pharma Market : >$ 35 bn
¤ Brazil, Mexico, Argentina, Venezuela are the key markets
Glenmark’s
Presence
¤ 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 *
Carribea
Venezuel
n
a
5%
3%
FY 2009
(ending Mar’09)
Others
9%
FY 2010
(ending Mar’10)
Others
Mexico 7%
6%
Carribea
n
5%
Venezuel
a
4%
Peru
3%
Peru
3%
* Projected
Brazil
80%
Brazil
75%
33
RoW Markets
Australasia (excluding India, CIS & Japan)
Malaysia
Philippines
Indonesia
China
South Korea
Myanmar
Vietnam
Sri Lanka
Cambodia
Australia
Glenmark Pharmaceuticals Limited: Specialty Business
Australasia– Performance FY 2008
32
Revenues in $ mn
11
FY 2008
ending Mar’08
13
FY 2009 *
FY 2010 *
ending Mar’09
ending Mar’10
Highlights
¤
¤
¤
* Projected
Launched over 60 products
Filed for over 100 product approvals
Top-10 brands contribute over 65% of the business
35
Glenmark Pharmaceuticals Limited: Specialty Business
Australasia – Action Plan
¤ Australasia Pharma Market (excluding India, Japan, CIS) : >$ 55 bn
Glenmark’s
Presence
¤ 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
Action Plan
FY 2009
¤ Register growth of over 20 %
¤ File for 100 product approvals and launch 30 products
Revenue contribution *
Malaysia
24%
Indonesia
15%
FY 2009
(ending Mar’09)
Malaysia
19%
FY 2010
(ending Mar’10)
Australia
15%
Phillipines
21%
Phillipines
18%
Others
55%
Others
18%
China
15%
* Projected
36
RoW Markets
Africa
South Africa
Nigeria
Kenya
Sudan
Egypt
Tanzania
Yemen
Ivory Coast
Zambia
Mauritius
Uganda
Cameroon
Ghana
Includes middle east countries
Glenmark Pharmaceuticals Limited: Specialty Business
Africa– Performance FY 2008
42
Revenues in $ mn
25
18
FY 2008
ending Mar’08
FY 2009 *
ending Mar’09
FY 2010 *
ending Mar’10
Highlights
¤
¤
¤
¤
* Projected
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
38
Glenmark Pharmaceuticals Limited: Specialty Business
Africa – Action Plan
¤ Africa Pharma Market : >$ 10 bn
¤ South Africa, Nigeria, Sudan, Kenya, Egypt are key markets
Glenmark’s
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 %
¤ File for 75 products and launch 45 products
Action Plan
FY 2009
¤ Plans to enter Algeria, UAE
¤ Look for brand acquisition opportunities for entry/growth
Sudan
14%
Nigeria
11%
* Projected
Revenue contribution *
South
Africa
20%
FY 2009
(ending Mar’09)
Kenya
14%
Others
41%
Sudan
12%
Egypt
12%
South
Africa
25%
FY 2010
(ending Mar’10)
Kenya
12%
Nigeria
15%
Others
24%
39
RoW Markets
CIS
Russia
Ukraine
Uzbekistan
Kazakhstan
Glenmark Pharmaceuticals Limited: Specialty Business
CIS – Performance FY 2008
66
Revenues in $ mn
38
22
FY 2008
FY 2009 *
FY 2010 *
ending Mar’08
ending Mar’09
ending Mar’10
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
* Projected
41
Glenmark Pharmaceuticals Limited: Specialty Business
CIS – Action Plan
¤ CIS Pharma Market : >$ 15 bn
Glenmark’s
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
Ukraine
4%
Uzbekist
an
4%
¤ File for 25 product approvals
¤ Launch 25 products
Revenue contribution *
Kazakhs
tan
1%
Russia
91%
* Projected
FY 2009
(ending Mar’09)
Uzbekist
an
3%
Ukraine
4%
Kazakhs
tan
1%
FY 2010
(ending Mar’10)
Russia
92%
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
40
Revenues in $ mn
20
9
FY 2008
ending Mar’08
FY 2009 *
ending Mar’09
FY 2010 *
ending Mar’10
* Projected
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 Glenmark’s 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
¤ 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
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
New
14%
Revenue contribution *
Bulgaria
3%
Bulgaria
12%
Czech
50%
Romania
28%
Czech
69%
Romania
24%
FY 2009
ending Mar’09
* Projected
FY 2010
ending Mar’10
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 %
69
69
Business Mix
60
9
22
11
18
48
*
NCE
66
Europe
CIS
32
42
80
152
175
FY 2008
FY 2009
FY 2010
93
(ending Mar 09)
123
In $ mn (Assumed exchange rate of ~40.28 INR/USD for FY08 and ~ 40 INR/USD for FY09 and FY10)
Australasia
Africa
LatAm
India
60
135
(ending Mar 08)
Profits
In $ mn
20
38
13
25
40
(ending Mar 10)
157
CAGR ~ 30%
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 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.
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
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
303
Revenues in $ mn
207
140
50
FY 2007
ending Mar’07
FY 2008
ending Mar’08
FY 2009 *
ending Mar’09
FY 2010 *
ending Mar’10
Highlights
¤
¤
¤
¤
* Projected
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
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
30 Bn are
going off-patent
20
2009
22
2010
2011
Values in $ Bn
59
Glenmark Generics Limited: Generics Business
North America – Glenmark’s rise as a generic player
¤ GGI, USA (Glenmark Generics Inc.) launched the
first product in Jan 2005
Background
¤ Registered net revenues of $ 140 mn in FY 2008
Product Portfolio
28
¤ 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
13
6
FY 2006
ending Mar’06
FY 2007
FY 2008
ending Mar’07
ending Mar’08
Highlights
¤ 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®
60
Glenmark Generics Limited: Generics Business
US: Plan for ANDA Filings
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
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
GGL’s 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)
26
18
10
Till FY
2008
FY
2009
ending Mar’08 ending Mar’09
FY
2010
ending Mar’10
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
GGL’s Portfolio
size $ 200 mn)
¤ 3 controlled substances already launched
¤ 7 additional products anticipated to be launched
within next 3 years
12
Fillings (Cumulative)
8
4
Till FY
2008
FY
2009
FY
2010
ending Mar’08 ending Mar’09 ending Mar’10
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.
GGL’s Portfolio
¤ 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]
26
Fillings (Cumulative)
16
6
Till FY
2008
FY
2009
ending Mar’08 ending Mar’09
FY
2010
ending Mar’10
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
GGL’s portfolio
portfolio [10 products anticipated (current market size $1
bn) to be launched within next 3 years]
12
Fillings (Cumulative)
7
2
Till FY
2008
FY
2009
FY
2010
ending Mar’08 ending Mar’09 ending Mar’10
65
Glenmark Generics Limited: Generics Business
US Product Portfolio: Oncology
¤ Total Oncology Market in the United States is over $10 bn
¤ Key generic players include: Teva Sicor, Ben-Venue &
The Market
Barr
¤ Higher margins on Oncology Products
¤ Limited players
¤ Dedicated facility required
¤ Portfolio includes a mix of 14 solid oral dosage and 13
GGL’s portfolio
injectable products (Total market size: >$ 7.5 bn)
9
Fillings (Cumulative)
4
0
Till FY
2008
ending Mar’08
FY
2009
FY
2010
ending Mar’09 ending Mar’10
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)
6
Till FY
2008
9
FY
2009
ending Mar’08 ending Mar’09
12
FY
2010
ending Mar’10
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
¤ $ 182 bn
¤ Generic penetration is low as compared to the
Market Size
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
in 2004
Background
¤ 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
10
Revenues in $ mn
4
0.2
FY 2008
* Projected
ending Mar’08
FY 2009 *
ending Mar’09
FY 2010 *
ending Mar’10
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)
25
15
5
Till FY 2008
ending Mar’08
FY 2009
ending Mar’09
FY 2010
ending Mar’10
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
25
15
Revenues in $ mn
8
6
* Projected
FY 2007
FY 2008
ending Mar’07 ending Mar’08
FY 2009 *
ending Mar’09
FY 2010 *
ending Mar’10
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)
515
405
310
Till FY 2008
ending Mar’08
FY 2009
ending Mar’09
FY 2010
ending Mar’10
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
90
70
48
Sales in $ mn
30
* Projected
FY 2007
FY 2008
FY 2009 *
FY 2010 *
ending Mar’07 ending Mar’08 ending Mar’09 ending Mar’10
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 Mar’08
31
FY 2009
FY 2010
ending Mar’09
ending Mar’10
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 %
25
90
15
Argentina
70
API
Business Mix
8
48
US and EU generics
313
211
140
FY 2008
(ending Mar 08)
Profits
In $ mn
*
64
FY 2009
(ending Mar 09)
87
In $ mn (Assumed exchange rate of ~40.28 INR/USD for FY08 and ~ 40 INR/USD for FY09 and FY10)
FY 2010
(ending Mar 10)
125
CAGR ~ 39%
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
504
Specialty
377
Generics
303
196
FY 2008
(ending Mar 08)
296
FY 2009
(ending Mar 09)
428
FY 2010
(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