Lupin Corporate Presentation Nov 2005

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Investor Presentation
November 2005
1
Safe Harbour Statement
Materials and information provided during this presentation may contain ‘forward-looking statements’. These statements are
based on current expectations, forecasts and assumptions that are subject to risks and uncertainties which could cause actual
outcomes and results to differ materially from these statements.
Risks and uncertainties include general industry and market conditions, and general domestic and international economic
conditions such as interest rate and currency exchange fluctuations. Risks and uncertainties particularly apply with respect to
product-related forward-looking statements. Product risks and uncertainties include, but are not limited, to technological
advances and patents attained by competitors, challenges inherent in new product development, including completion of clinical
trials; claims and concerns about product safety and efficacy; obtaining regulatory approvals; domestic and foreign healthcare
reforms; trends toward managed care and healthcare cost containment, and governmental laws and regulations affecting
domestic and foreign operations.
Also, for products that are approved, there are manufacturing and marketing risks and uncertainties, which include, but are not
limited, to inability to build production capacity to meet demand, unavailability of raw materials, and failure to gain market
acceptance.
The Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of
new information, future events or otherwise.
2
Agenda
 Pharmaceutical Industry Overview
 Lupin – A Differentiated Business Model
 Financial Overview
 Business Strategy and Investment Highlights
3
Pharmaceutical Industry Overview
Global Pharmaceutical Industry Overview
 Estimated to be a US$550 billion market in 2004 (including estimated
Global Pharmaceutical Sales*
unaudited pharmaceutical sales)
 Market expected to grow at a rate of 7% to 9%
525
revenue
 North America is the single largest market accounting for approx. 50%
of global sales and is expected to grow at a CAGR of 10%
 EU was the fastest growing market, growing at a CAGR of 26% in the
period 2002 – 2004
Emerging Trends
 Growing importance of generics in regulated markets
 Pressure from healthcare providers and insurance companies to reduce
healthcare costs driving usage of generic drugs
 Increasing patent expirations driving generic drug availability
 Legislative changes such as the enactment of the Hatch-Waxman act
and changes to the Medicare Act in the US providing a major boost
 Stringent testing requirements and declining R&D productivity has led
to limited new drug pipeline
 Increasing pressure on big pharmaceutical companies to enhance new
drug pipeline
US$ Bn
 Regulated markets account for almost 90% of the market in terms of
518
59
9
58
466
450
401
375
48
11
47
300
55
14
52
144
115
91
225
150
248
230
204
75
-
2002
North America
EU
2003
Japan
2004
Rest of Europe
Source: IMS World Review (Industry Sales based on Audited Numbers)
Key Generic Drug Markets
France
Italy
1.9
2.5
Japan
UK
3.3
4.1
Germany
5.3
India
5.7
US
-
24.8
5.0
10.0
15.0
20.0
US$ Bn
4
Rest of World
The generic drugs market which is expected to grow at 10%-12% over the next few years is a
key growth area for emerging pharmaceutical manufacturers
25.0
30.0
Factors driving the Indian Pharmaceutical
Industry
Generic Exports and API Outsourcing
Indian Pharmaceutical Market
Overview
Approximately US$5 bn in 2004 with
exports accounting for an additional
US$2.5 bn
 Amongst top 4 markets by volume
globally
 Strong branded generics market
 Market growing at a rate 6%-8% as a
result of growing awareness, increasing
penetration & increasing affordability
 Emerging segments such as CNS,
diabetes etc. growing at 15-20% +
 Introduction of product patents in India in
2005 are expected to lead to a greater
emphasis on drug discovery and
development
5
Growth Opportunities

India is well positioned to target generic exports and API
outsourcing opportunities in the regulated markets
Skilled work force with strong chemistry skills
Significant and sustainable cost advantage over
international peers
Good understanding of the regulatory framework
 India has largest number of US FDA approved plants
outside the US
 Largest number of DMF filings outside US
 Indian companies are among the leading players
participating in Para IV challenges
R&D Outsourcing


Skilled work force at competitive costs
Significant progress in development of pharma & R&D
infrastructure over last 5 years
 Focus on early stage processes for NCEs, NDDS, clinical
trials, process re-engineering and dedicated
manufacturing
A combination of strong chemistry skills, regulatory capabilities and quality manufacturing
has positioned India favorably to capitalize on the global pharmaceutical opportunity
Lupin – A Differentiated Business
Model
Business Overview
 Among the top 6 pharmaceutical companies in India

Leading global player in anti-TB & Cephalosporins

Strong position in prils and emerging global player in
statins
Therapeutic Mix - FY 2005
CVS
21%
Cephs
43%
 Globally accredited manufacturing facilities
 Strong R&D Focus

Anti-TB
24%
14 ANDAs, 15 DMFs, 4 COS, 2 E-DMFs filed in FY2005

Four NCE molecules in clinical stage

R&D spend in FY2005 – US$18 mm
Others
12%
Geographical Mix - FY2005
 Focused on US, EU, Australia, Japan, India, China
and CIS

Share in Revenues from America & Europe increased
from 10% in FY2001 to 24% in FY2005
 Employs 4,259 people

6
Others
2%
Home to 260 scientists
America &
Europe
24%
India
53%
South East
Asia
21%
Product Profile - API & Intermediates
 Proven process chemistry as well as fermentation
skills
 Major therapeutic focus areas: anti-TB,
cephalosporins (both orals and injectables), prils
and statins
 Quality and cost leadership
Therapeutic Segment
Global
Rank
Ethambutol
Anti-TB
1
Rifampicin
Anti-TB
1
Product
 Relationship Driven model
Pyrazinamide
Going Forward
7ACCA
Cephalosporin Intermediate
2
7ADCA
Cephalosporin Intermediate
1
Lisinopril
Cardiovascular
1
 Extending global dominance across a wider portfolio
 Increasing strategic partnerships / alliances
 Reap benefits of new and expanded capacities
Anti-TB
Amongst the top 2 globally in each area of focus
7
1
Product Profile - Finished Dosages
US Specialty
US Generics
 Focus on $ 7 Bn pediatric market thru a
dedicated sales force
 Fast building a pipeline of finished products for
the US market
 Foundation laid with the launch of Suprax® showing an increasing Rx trend
 ~50 products in current pipeline with brand
value of +$ 60 Bn
 Co-promotion with Cornerstone BioPharma for
Suprax® with focus on primary care physicians
 7 ANDA approved till date, 15 pending
approval
 Looking at justifiable brand acquisitions and inlicensing opportunities
 $756 mn Ceftriaxone launched in July 2005
with Baxter Healthcare and Henry Schein
 Positioning to market other products from own
NDDS platform
 API supply to Baxter Healthcare for Premix
Frozen
 7 products planned for launch in FY 2006
 Target = +15 ANDA filings every year
 Target = +25 product basket by FY 2008
8
Success Strategy: Focus generic opportunities in regulated markets
Product Profile - Finished Dosages
India
 Portfolio of over 80 finished products with
focus on anti-TB, anti-infectives, NSAIDS
cardiovasculars and diabetes

20 brands in the 'Top 3' of their respective
product segments
 Business growing at a rate of 9% as against
2% growth in the overall industry
 18 new products launched in 2005 including
anti-Asthma
 1350 strong field force for marketing
9

Marketing divisions with specific therapeutic
focus

Extending reach to access rural markets thru
brand building
Other Markets
 Fast building a pipeline of finished products for
the other markets with strong R&D focus
 Partnership business model in EU with own
setup in select markets

+350 EOIs received till date

Plan to file 8-12 dossiers in FY 2006
 Entering Japanese generic market thru
alliances

Co-operation agreement with Kyowa Pharma
signed for multiple products
 Consolidating presence in CIS market by
introducing more products
 Entering the Australian market with value
added generics through alliances
Success Strategy: Strong R&D focus with broad market specific product offering
US / EU Product Development
US
EU
 Filings till date
22
-
 Approvals till date
7
-
+15
8-12
7
0
25-30
8-12
+15
6-8
 Target filings in FY06
 Target launches in FY06
 Products under development
 Target filings going forward per year
10
Globally Accredited Facilities
Mandideep
Ankleshwar
Tarapur
Pune
Goa
Aurangabad
Manufacturing
LOCATION
PRODUCTS
APPROVALS
Mandideep,
Cephalosporins
USFDA, UK MHRA, TGA
Madhya Pradesh
Prils
USFDA
Tarapur,
Rifampicin
USFDA, UK MHRA
Maharashtra
Lovastatin
-
Ankleshwar,
Ethambutol
USFDA
Gujarat
Intermediates
USFDA
Aurangabad,
Rifampicin
WHO, MCC (South Africa)
Maharashtra
Pyazinamide
WHO, MCC (South Africa)
Ethambutol
WHO, MCC (South Africa)
Lisinopril
WHO, MCC (South Africa)
Noncephalosporin
Oral
Formulations
USFDA
Verna,
Goa
Research Center
Pune,
Maharashtra
11
R&D
Strong Research & Development Focus
Process
NDDS

Proven abilities in process
chemistry and fermentation

First licensing deal signed for antiinfective product

Ability to develop products with
high technology barriers

Three patented platforms for
delivery systems

Two products launched in India

30 DMF and 75 EDMFs filed
NDDS
Process
ANDA
NCE
NCE
ANDA


12

22 ANDAs filed,7 approved including $756mn Ceftriaxone
Anti-migraine and anti-psoriasis
(herbal) in Phase IIa trials

Broad range of filings with wide
therapeutic coverage
Anti -tb and anti-psoriasis
(chemical) in phase I trials

Anti-diabetes and anti-bacterial in
pre-clinical stages
Experienced Management Team
NAME
POSITION
Desh Bandhu
Gupta, Ph.D
Chairman
Kamal K Sharma,
Ph.D
Managing
Director
Satish Khanna
Group President,
API
Vinita Gupta
Sharma
President, Lupin
Pharmaceuticals
Inc, US
Himadri Sen, Ph.D
President, Pharma
research
Shakti
Chakraborty
President, India
Region
Formulations
Vinod Dhawan
President--Business
Development

Divakar Kaza
President, Human
Resources

Indrajit Banerjee
President, Finance
& Planning

Harish Narula
President Corporate
Affairs

Nilesh Gupta
Exec VP, IPMG
13
BRIEF PROFILE


Founded the company in 1968
Started his career teaching chemistry at Birla Institute of Science and Technology, Pilani, Rajashthan

Experience of more than three decades at a range of senior management positions managing projects, corporate
development and general management in the pharmaceuticals and chemicals industries


Strengthened Lupin's API business and secured the company's position among top manufacturers, globally
Rich experience of more than 25 years in leading companies including Mitsu Industries, Tata Chemicals and Union
Carbide

Has led Lupin's foray in the advanced markets of the US and Europe and in cementing alliances with global majors

Spearheading Lupin's drive for NDDS, ANDA and patent fillings
Has worked with leading Indian and global pharma companies in the areas of pharma research, technology development
and transfer and manufacturing support








Has driven Lupin's entry in the lifestyle segments
Experience of more than three decades with leading pharmaceutical companies like Wockhardt, Aristo Pharma
Heads the AAMLA region, responsible for the development of Lupin’s business strategy for these markets.
Has worked with Ranbaxy in their international business
Responsible for developing HR management strategy and align it with overall business strategy of the company
Brings along with him rich business experience of about 2 decades in organizations like Wipro, General Electric etc
Responsible for the finance, IT and planning functions and align it with overall business strategy of the company
Rich experience of more than 2 decades in organizations like Indal, Lucent Technologies
Heads the company’s business initiatives in the CIS region
Supports the businesses through various Embassies and trade Associations
Responsible for driving product identification for the advanced markets identifying in-licensing and out-licensing
opportunities
Financial Overview
Financial Profile
Revenues
268
260
240
214
220
200
180
25.0
271
Net Income (US$ MM)
Revenue (US$ MM)
280
Net Income
175
160
160
22.7
22.0
19.4
19.0
16.6
16.0
13.8
13.0
10.0
140
FY2001
FY2002
FY2003
FY2004
FY2001
FY2005
EBITDA / Interest Coverage
5.4
FY2003
FY2004
FY2005
2.5
5.3
2.0
5.0
4.0
2.9
2.9
2.3
2.0
2.0
-
FY2003
FY2004
FY2005
1.7
1.0
0.5
FY2002
1.8
1.5
1.0
FY2001
14
FY2002
Debt / Equity
Debt / Equity (x)
EBITDAa/ Interest (x)
6.0
3.0
17.6
FY2001
FY2002
FY2003
0.8
0.9
FY2004
FY2005
Regulated Markets Driving Growth
Half Year Ended Sep 30
YOY
Key Highlights
(US$ Millions)
2004
2005
Growth
Income Statement Data

Export Revenue increased by 36%
Revenue
141.1
178.3
26.4%
EBITDA
17.0
34.3
101.8%
EBIT
13.4
30.0
124.8%
Interest
3.0
2.9
(2.9%)
PBT
10.3
27.1
162.2%

Finished dosage increased by 533%
PAT
8.7
20.1
131.7%

API revenue increased by 15%
Key Ratios
12.6%
19.9%
-
PAT Margins
6.4%
11.7%
-
EBITDA/ Interest
5.6x
11.7x
-
EBITDA Margins
15
 Revenue increased by 26%
 Buoyant off-take in regulated market
with sales increasing by 85% to
US$38.9 mm
 Profit margins improved substantially
with reduction in costs
Business Strategy and Investment
Highlights
Business Strategy
Continued growth of
Anti-TB and
Cephalosporin Business
Strong Corporate
Governance
Broad Basing the
Product Basket
16
Strengthen Presence in
Lifestyle Drugs
Sustainable
Growth
Penetrate Regulated
Markets
ANDA, NDDS and NCE
Investment Highlights
Leadership status in the global anti – TB and cephalosporin market
Strong growth opportunity driven by Lupin’s entry into regulated markets
which are supported by its strong DMF and ANDA pipeline
US FDA/ EDQM/ Australian TGA compliant manufacturing facilities
Increased focus on research programme including ANDA, NDDS and NCE
providing multiple drivers of growth going forward
Marketing tie-ups with global players
17
Thank You
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