lupin presentation in 2005 citigroup indian health care conference

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Investor Presentation October 2005 1

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Page 1: Lupin Presentation in 2005 Citigroup Indian Health Care Conference

Investor Presentation

October 20051

Page 2: Lupin Presentation in 2005 Citigroup Indian Health Care Conference

Safe Harbour StatementMaterials 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

Page 3: Lupin Presentation in 2005 Citigroup Indian Health Care Conference

Agenda Pharmaceutical Industry Overview Lupin – A Differentiated Business Model Financial Overview Business Strategy and Investment Highlights

3

Page 4: Lupin Presentation in 2005 Citigroup Indian Health Care Conference

Pharmaceutical Industry Overview

Page 5: Lupin Presentation in 2005 Citigroup Indian Health Care Conference

204 230 248

91115

1444752

58

1114

9

4855

59401

466 518

-

75

150

225

300

375

450

525

2002 2003 2004North America EU Japan Rest of Europe Rest of World

US

$ B

n

Global Pharmaceutical Industry OverviewGlobal Pharmaceutical Sales*

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

Emerging Trends

Estimated to be a US$550 billion market in 2004 (including estimated unaudited pharmaceutical sales)

Market expected to grow at a rate of 7% to 9% Regulated markets account for almost 90% of the market in terms of

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

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

CAGR – 13.7%

Source: IMS World Review (Industry Sales based on Audited Numbers)

Key Generic Drug Markets

24.8

5.7

5.3

4.1

3.3

2.5

1.9

- 5.0 10.0 15.0 20.0 25.0 30.0

US

India

Germany

UK

Japan

Italy

France

US$ Bn

4

Page 6: Lupin Presentation in 2005 Citigroup Indian Health Care Conference

Factors driving the Indian Pharmaceutical Industry

A combination of strong chemistry skills, regulatory capabilities and quality manufacturing has positioned India favorably to capitalize on the global pharmaceutical opportunity

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

Grow

th Opportunities

Generic Exports and API OutsourcingIndia is well positioned to target generic exports and API outsourcing opportunities in the regulated marketsSkilled work force with strong chemistry skillsSignificant 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

5

Page 7: Lupin Presentation in 2005 Citigroup Indian Health Care Conference

Lupin – A Differentiated Business Model

Page 8: Lupin Presentation in 2005 Citigroup Indian Health Care Conference

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

Globally accredited manufacturing facilities

Strong R&D Focus 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

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 Home to 260 scientists

Therapeutic Mix - FY 2005

Geographical Mix - FY2005

Cephs43%

Others12%

Anti-TB24%

CVS21%

South East Asia21%

India53%

Others2% America &

Europe24%

6

Page 9: Lupin Presentation in 2005 Citigroup Indian Health Care Conference

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

Relationship Driven model

Going Forward

Extending global dominance across a wider portfolio

Increasing strategic partnerships / alliances

Reap benefits of new and expanded capacities

Amongst the top 2 globally in each area of focus

Product Therapeutic Segment

Global

RankEthambutol Anti-TB 1

Rifampicin Anti-TB 1

Pyrazinamide Anti-TB 1

7ACCA Cephalosporin - Intermediate 2

7ADCA Cephalosporin - Intermediate 1

Lisinopril Cardiovascular 1

7

Page 10: Lupin Presentation in 2005 Citigroup Indian Health Care Conference

Product Profile - Finished Dosages

Focus on $ 7 Bn pediatric market thru a dedicated sales force

Foundation laid with the launch of Suprax® - showing an increasing Rx trend

Co-promotion with Cornerstone BioPharma for Suprax® with focus on primary care physicians

Looking at justifiable brand acquisitions and in-licensing opportunities

Positioning to market other products from own NDDS platform

US Specialty US Generics

Fast building a pipeline of finished products for the US market

~50 products in current pipeline with brand value of +$ 60 Bn

7 ANDA approved till date, 12 pending approval

$756 mn Ceftriaxone launched in July 2005 with Baxter Healthcare and Henry Schein

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

Success Strategy: Focus generic opportunities in regulated markets8

Page 11: Lupin Presentation in 2005 Citigroup Indian Health Care Conference

Product Profile - Finished Dosages

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 Marketing divisions with specific therapeutic

focus

Extending reach to access rural markets thru brand building

India 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 offering9

Page 12: Lupin Presentation in 2005 Citigroup Indian Health Care Conference

US EU Filings till date 19 -

Approvals till date 7 -

Target filings in FY06 +15 8-12

Target launches in FY06 7 0 Products under development 25-30 8-12

Target filings going forward per year +15 6-8

US / EU Product Development

10

Page 13: Lupin Presentation in 2005 Citigroup Indian Health Care Conference

Globally Accredited Facilities

ManufacturingManufacturing

Research CenterResearch Center

Goa

PunePune

Tarapur Tarapur

AnkleshwarAnkleshwar Mandideep Mandideep

Aurangabad Aurangabad

LOCATION PRODUCTS APPROVALS

Mandideep, Madhya Pradesh

CephalosporinsPrils

USFDA, UK MHRA, TGA USFDA

Tarapur, Maharashtra

RifampicinLovastatin

USFDA, UK MHRA-

Ankleshwar, Gujarat

EthambutolIntermediates

USFDAUSFDA

Aurangabad, Maharashtra

RifampicinPyazinamideEthambutolLisinopril

WHO, MCC (South Africa)WHO, MCC (South Africa)WHO, MCC (South Africa)WHO, MCC (South Africa)

Verna, Goa

Non-cephalosporin Oral Formulations

USFDA

Pune, Maharashtra

R&D

11

Page 14: Lupin Presentation in 2005 Citigroup Indian Health Care Conference

Strong Research & Development Focus

Process

ANDA

NCE

NDDS

NDDSProcess

ANDA NCE

First licensing deal signed for anti-infective product

Three patented platforms for delivery systems

Two products launched in India

Proven abilities in process chemistry and fermentation

Ability to develop products with high technology barriers

30 DMF and 75 EDMFs filed

19 ANDAs filed,7 approved - including $756mn Ceftriaxone

Broad range of filings with wide therapeutic coverage

Anti-migraine and anti-psoriasis (herbal) in Phase IIa trials

Anti -tb and anti-psoriasis (chemical) in phase I trials

Anti-diabetes and anti-bacterial in pre-clinical stages12

Page 15: Lupin Presentation in 2005 Citigroup Indian Health Care Conference

Experienced Management TeamNAME POSITION BRIEF PROFILE

Desh Bandhu Gupta, Ph.D Chairman

Founded the company in 1968 Started his career teaching chemistry at Birla Institute of Science and Technology, Pilani, Rajashthan

Kamal K Sharma, Ph.D

Managing Director

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

Satish Khanna Group President, API

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

Vinita Gupta Sharma

President, Lupin Pharmaceuticals Inc, US

Has led Lupin's foray in the advanced markets of the US and Europe and in cementing alliances with global majors

Himadri Sen, Ph.D President, Pharma research

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

Shakti Chakraborty

President, India Region Formulations

Has driven Lupin's entry in the lifestyle segments Experience of more than three decades with leading pharmaceutical companies like Wockhardt, Aristo Pharma

Vinod Dhawan President--Business Development

Heads the AAMLA region, responsible for the development of Lupin’s business strategy for these markets. Has worked with Ranbaxy in their international business

Divakar Kaza President, Human Resources

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

Indrajit Banerjee President, Finance & Planning

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

Harish Narula President Corporate Affairs

Heads the company’s business initiatives in the CIS region Supports the businesses through various Embassies and trade Associations

Nilesh Gupta Exec VP, IPMG Responsible for driving product identification for the advanced markets identifying in-licensing and out-licensing

opportunities

13

Page 16: Lupin Presentation in 2005 Citigroup Indian Health Care Conference

Financial Overview

Page 17: Lupin Presentation in 2005 Citigroup Indian Health Care Conference

Financial Profile

Revenues Net Income

EBITDA / Interest Coverage Debt / Equity

1.82.0

1.7

0.8 0.9

-

0.5

1.0

1.5

2.0

2.5

FY2003 FY2004 FY2004 FY2004 FY2005

Deb

t / E

quity

(x)

160175

214

268 271

140

160

180

200

220

240

260

280

FY2003 FY2004 FY2004 FY2004 FY2005

Rev

enue

(US

$ M

M) CAGR – 14.1%

2.32.9 2.9

5.4 5.3

-

1.0

2.0

3.0

4.0

5.0

6.0

FY2003 FY2004 FY2004 FY2004 FY2005

EB

ITD

Aa/

Inte

rest

(x)

13.8

16.617.6

22.7

19.4

10.0

13.0

16.0

19.0

22.0

25.0

FY2003 FY2004 FY2004 FY2004 FY2005

Net

Inco

me

(US

$ M

M)

14

Page 18: Lupin Presentation in 2005 Citigroup Indian Health Care Conference

Regulated Markets Driving Growth

Revenue increased by 21%

Export Revenue increased by 30%

Buoyant off-take in regulated market with sales increasing by 84% to US$16.7 mm

Finished dosage increases by 143%

API revenue increased by 59%

Suprax Revenue touched US$3.9 mm

Profit margins improved substantially with reduction in costs

Key HighlightsQuarter Ended June 30 YOY

2004 2005 Growth

Income Statement Data

Revenue 69.3 83.7 20.8%

EBITDA 9.4 17.1 81.4%

EBIT 7.6 15.0 97.2%

Interest 1.6 1.5 (8.2%)

PBT 6.0 13.5 125.8%

PAT 4.7 9.9 109.1%

Key Ratios

EBITDA Margins 14.2% 21.2% -

PAT Margins 7.1% 12.3% -

EBITDA/ Interest 5.8x 11.5x -

(US$ Millions)

15

Page 19: Lupin Presentation in 2005 Citigroup Indian Health Care Conference

Business Strategy and Investment Highlights

Page 20: Lupin Presentation in 2005 Citigroup Indian Health Care Conference

Business Strategy

Continued growth of Anti-TB and

Cephalosporin Business

Strengthen Presence in Lifestyle Drugs

Strong Corporate Governance

Penetrate Regulated Markets

Broad Basing the Product Basket ANDA, NDDS and NCE

SustainableGrowth

16

Page 21: Lupin Presentation in 2005 Citigroup Indian Health Care Conference

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

Page 22: Lupin Presentation in 2005 Citigroup Indian Health Care Conference

Thank You