lupin limited corporate presentation august 2006

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Lupin Limited Corporate Presentation August 2006

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Page 1: Lupin Limited Corporate Presentation August 2006

Lupin LimitedCorporate Presentation

August 2006

Page 2: Lupin Limited Corporate Presentation August 2006

2

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.

Page 3: Lupin Limited Corporate Presentation August 2006

3

Contents

Contents Pg Nos

Introduction 4

Pharmaceutical Industry Overview 6

Approach 9

Advanced Markets 14

Other Emerging Markets 19

API & Intermediates 22

Research & Development 25

Business Update 29

Facilities 36

Management 38

And Beyond 40

Page 4: Lupin Limited Corporate Presentation August 2006

4

Introduction . . .

Section 1Section 1

Page 5: Lupin Limited Corporate Presentation August 2006

5

Vision

• To be an Innovation led Transnational Pharmaceutical Company

Values

• Superior Performance

• Entrepreneurship

• Customer Orientation

• Working Together

• Respect for People

• Integrity

Page 6: Lupin Limited Corporate Presentation August 2006

Pharmaceutical Industry Overview

Section 2Section 2

Page 7: Lupin Limited Corporate Presentation August 2006

7

Global Pharmaceutical Industry Overview

Global Pharmaceutical market at US$600 billion market in 2005 Market expected to grow at a rate of 6-7%

Ten major markets account for almost 81% 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 5-8%

Japan, the second largest market, at US$60bn is growing at 6%

EU experiencing growth at 7% at US$ 170bn

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

Stringent testing requirements and declining R&D productivity has led to limited new drug pipeline

Page 8: Lupin Limited Corporate Presentation August 2006

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Indian Pharma – Emerging Scenario

DOMESTIC FORMULATIONS

• IPR Regime Pricing pressure on ‘older’ molecules Brands/ differentiated products Likely to witness higher growth In Licensing

GENERICS BUSINESS

• Increasing competitive landscape Pricing pressure Aggressive build up of products Acquisitions US$ 60 bn opportunity

CONTRACT MANUFACTURING

• JV/ Alliances

• Competition from China

INDIGENOUS R&D

• ANDA/NDDS/NCE

• Out Licensing

• High Investment/ Long gestation

Indian Pharma

Domestic Market: US$ 5bn Exports: US$ 2.5bn Total: US$ 7.5bn

Page 9: Lupin Limited Corporate Presentation August 2006

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Approach

Section 3Section 3

Page 10: Lupin Limited Corporate Presentation August 2006

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Lupin Strives For

Sustainable Earnings

Accelerated Growth

Fulfilling Stakeholder Aspirations

Page 11: Lupin Limited Corporate Presentation August 2006

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Creating an Edge

Technology• New Delivery Systems

• Complex Products

• Bottom Quartile of costs for generic products

• Integration

• NCE

Markets• Expansion & Efficiency in Sales Force

• ‘Direct to Market’ approach in US

• Build on Paediatric

• On-shore presence in 5 select countries

Alliances• Partnerships in Japan, Australia, Latin America

• TB Institutional

• Alliances with Global majors for certain markets

• New therapies (In-Licensing)

Page 12: Lupin Limited Corporate Presentation August 2006

12

Regulated Markets (US): Lupin Approach

LUPINLUPIN

Generics Para III

Specialty

Para IV ComplexGenerics Branded

Generics

Lisinopril…

Ramipril…

Ceftriaxone...

NCE/

ND

DS

Suprax…

Other Regulated Markets:

• Focus on Branded Products

• Partnerships & Alliances

Page 13: Lupin Limited Corporate Presentation August 2006

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Developing Markets : Lupin Approach

Rural

IND

IA/ C

IS/ AA

ME

/ LA

SpecialtyPost 2005

In-licensing

Ceff-E

R, Odo

xil O

D, …

Lup

inov

aNDDS

LUPINLUPIN

Global Tenders

GTB

Enoxaparin Sodium…

Branded Generics

Urban

Page 14: Lupin Limited Corporate Presentation August 2006

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Advanced Markets

Section 4Section 4

Page 15: Lupin Limited Corporate Presentation August 2006

15

US

Branded Suprax continues its prescription growth: over 5000Rx per week Sales force internalised Copromotion of Atopiclair with Chester Valley New Products in 2006-07

Generics 7 products launched in the US in 2005-06 Timely launch of Ceftriaxone and Cefprozil immediately on expiry Launched Lisinopril in Dec05: Consolidating Market share Commenced Direct Marketing (DTM) in Dec05 Total ANDAs filed: over 40

Page 16: Lupin Limited Corporate Presentation August 2006

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Generics US

Target Therapies

Mkt size Lupin

$ billion No. of products

Launched till now

Cephalosporins 2 10 7

CVS 25 15 1

CNS 15 11 -

Anti-ulcer 13 4 -

Macrolides 2 2 -

Others 3 3 -

Total 60 45 8

Page 17: Lupin Limited Corporate Presentation August 2006

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Other Markets

Europe

• Ramping up MAA/ Dossier filings

• Alliances in progress• Revenues commenced

• Expressions of interest at advanced stages

Japan, Australia & LA

• Expressions of interest moving forward

• MDR-TB sales commenced in LA

South Africa

• JV with Aspen (Anti-TB FDC) for Africa

Page 18: Lupin Limited Corporate Presentation August 2006

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Robust pipeline

Country Total submissions

US 41

EU 12

France 2

Australia/ NZ 11

RoW 1230

Page 19: Lupin Limited Corporate Presentation August 2006

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Other Emerging Markets

Section 5Section 5

Page 20: Lupin Limited Corporate Presentation August 2006

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India Region Formulations

• Growing at 23% vs 16% industry average (FY 06)

Contributed by CVS (41%), and GI (38%)

• Anti-Asthma range launched in Aug 04, already number 2 in its segment and growing (119%)

• Signoflam (Endeavour), the best product launch (IMS Data) of the year 2005 in the industry

• Lupinova driving foray into rural and less penetrated regions

• Top 10 brands

Odoxil 77 R-Cinex 101

AKT – 4 93 Cefaxone 41

Ceff 44 Tonact 96

AkuriT – 4 56 L-Cin* 49

Rablet 62 Ramistar 47

Rs. Mn ORG-MAT JAN 06*introduced in last 3 years

Page 21: Lupin Limited Corporate Presentation August 2006

21

Other Markets

CIS

• Posted a healthy growth – CAGR of 44% over last 4 years

• Expanding Field Force – • Russia, Ukraine, Azerbaijan, Kazakhstan, Uzbekistan

• Increased market penetration

• Around 20 Products Registered in each; around 10 under Registration

SE Asia

• Alliance with GSK

Middle East

• Will be shared as Alliances progress

Africa

• Alliance with Ranbaxy

GTB

• Posted a healthy growth – 122%

Page 22: Lupin Limited Corporate Presentation August 2006

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API & Intermediates

Section 6Section 6

Page 23: Lupin Limited Corporate Presentation August 2006

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API & Intermediates

• Sales : 11% growth• Ceftriaxone launched in US• Focus on Cost & Quality Leadership and

Reliability• Long Term Supply Contracts• Global Leadership in areas of therapeutic presence• Future expansion only at SEZs

Page 24: Lupin Limited Corporate Presentation August 2006

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Global Position in API & Intermediates

1Cephalosporin -

Intermediate7ADCA

1CardiovascularLisinopril

2Cephalosporin -

Intermediate7ACCA

1Anti-TBPyrazinamide

1Anti-TBRifampicin

1Anti-TBEthambutol

Global Rank

Therapeutic SegmentProduct

Two new products in 2006-07

Page 25: Lupin Limited Corporate Presentation August 2006

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Research & Development

Section 7Section 7

Page 26: Lupin Limited Corporate Presentation August 2006

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R&D

• Over 350 scientists– Actively engaged in: Process Improvement/ Formulation

Development/NCE/ NDDS

• Expenditure (FY0506) : Rs.1030mn – 6.2% of Sales– Continue investing incrementally

• Filings rate to continue

• Going Forward– NDDS

– Paediatrics range

– Patented Technology platforms

– Products for paediatric pipeline

Page 27: Lupin Limited Corporate Presentation August 2006

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R&D

• NCEs – Anti Psoriasis (Herbal) - In Phase II

– Anti Migraine - Nearing completion of Phase II

– Anti Psoriasis (Chemical) - In Phase II

– Anti TB - In Phase I

Page 28: Lupin Limited Corporate Presentation August 2006

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Patents

Patents Issued, Allowed & Pending302

Issued, Allowed 71

Pending231

US14

EU

RoW47

EU10

US31

EU18

RoW182

Page 29: Lupin Limited Corporate Presentation August 2006

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Business Update

Section 8Section 8

Page 30: Lupin Limited Corporate Presentation August 2006

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2005-06

6618

8896

5505

7714

12123

16610

02000400060008000

1000012000140001600018000

Domestic Exports Total

2004-05 2005-06

34% 40%

37%

(Rs

Mn)

Sales Growth

Fml Ind37%

Fml Reg13%

API SR10%

API Reg18%

API Ind17%

Fml SR5%

Revenue Composition

Page 31: Lupin Limited Corporate Presentation August 2006

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2005-06

• Revenue Growth : 37%

• EBITDA margin : 18%

• PBT : 14%

• PAT : 11%

• ROCE : 22%

844

18271458

3009

0

500

1000

1500

2000

2500

3000

3500

Net Profit EBITDA

2004-05 2005-06

106%(R

s M

n)

Profit Growth

116%

Page 32: Lupin Limited Corporate Presentation August 2006

32

2004-05

Exports45%

Domestic55%

Geographical Coverage

Exports46%

Domestic54%

2005-06

Page 33: Lupin Limited Corporate Presentation August 2006

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Anti Diabetics3%

Anti Asthma3%

Cephs23%

NSAIDS3%

CVS13%

Anti TB33%

Others22%

Therapeutic Coverage

2004-05

2005-06

Anti Diabetics6%

Anti Asthma4%

Cephs19%

NSAIDS4%

CVS16%

Anti TB26%

Others25%

Page 34: Lupin Limited Corporate Presentation August 2006

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2004-05

FD45%

API55%

API vs FD

FD55%

API45%

2005-06

Page 35: Lupin Limited Corporate Presentation August 2006

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3655

4851

0

1000

2000

3000

4000

5000

6000

Sales

Q1 FY0506 Q1 FY0607

432

507

380

400

420

440

460

480

500

520

Net Income

Q1 FY0506 Q1 FY0607

2006-07 – Q1(R

s M

n)

33%

17%

(Rs

Mn)

Page 36: Lupin Limited Corporate Presentation August 2006

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Facilities

Section 9Section 9

Page 37: Lupin Limited Corporate Presentation August 2006

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Lupin’s Facilities

Manufacturing

Research Center

Goa

Pune

Tarapur

Ankleshwar

Mandideep

Aurangabad

JammuLOCATION PRODUCTS APPROVALS

Mandideep,

Madhya Pradesh

Cephalosporins

Prils

USFDA, UK MHRA, TGA

USFDA

Tarapur,

Maharashtra

Rifampicin

Lovastatin

USFDA, UK MHRA

-

Ankleshwar,

Gujarat

Ethambutol

Intermediates

USFDA

USFDA

Aurangabad,

Maharashtra

Rifampicin

Pyrazinamide

Ethambutol

Lisinopril

WHO, MCC (South Africa)

WHO, MCC (South Africa)

WHO, MCC (South Africa)

WHO, MCC (South Africa)

Verna,

Goa

Non-cephalosporin Oral Formulations

USFDA, UK MHRA

Jammu,

J&K

Formulations -

Pune, Maharashtra

R&D

Mumbai,

Maharashtra

Head OfficeHead Office

Mumbai

Page 38: Lupin Limited Corporate Presentation August 2006

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Management

Section 10Section 10

Page 39: Lupin Limited Corporate Presentation August 2006

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Expert Management Team

NAME 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 KhannaGroup 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 President, Lupin Pharmaceuticals Inc, US

• Leads 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

• Spearheads 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 DhawanPresident--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

Indrajit Banerjee President, Finance & Planning

• Responsible for the finance, IT and planning functions and aligning it with overall business strategy of the company

Rajan Dutta 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 Xerox, Idea, Bharti Airtel,

etc

Harish NarulaPresident 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

opportunities13

Page 40: Lupin Limited Corporate Presentation August 2006

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and Beyond . . .

Section 11Section 11

Page 41: Lupin Limited Corporate Presentation August 2006

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Going Forward with

New Markets/ Initiatives

• Enter Advanced Markets EU Japan Australia South Africa

• Establish On-shore presence in 5 select markets

• Acquisition: Brands in US Businesses in select countries of EU Domestic

Page 42: Lupin Limited Corporate Presentation August 2006

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Going Forward with

Explore New Therapies/ Business Segments

• Therapeutic Areas Oncology Dermatology

• Business Segments Biosimilars CRAMS

Page 43: Lupin Limited Corporate Presentation August 2006

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Thank you