investor presentation may 2006 lupin. safe harbour statement materials and information provided...

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Investor Presentation May 2006 LUPIN

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Investor Presentation

May 2006

LUPIN

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.

Agenda

– Global Pharmaceutical Industry Overview

– Indian Pharmaceutical Industry

– Lupin -Business Update

– 2006-07 and Beyond

Lupin Limited

Vision

• To be an Innovation led Transnational Pharmaceutical Company

Values

• Superior Performance

• Entrepreneurship

• Customer Orientation

• Working Together

• Respect for People

• Integrity

Pharmaceutical Industry Overview

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

4

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

Lupin Strives For:

Sustainable Earnings

Accelerated Growth

Fulfilling Stakeholder Aspirations

Regulated Markets (US): Lupin Approach

LUPIN

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

Developing Markets : Lupin Approach

Rural

IRF/ C

IS/ AA

ME

/ LA

SpecialtyPost 2005

In-licensing

Ceff-E

R, Odo

xil O

D, …

Lup

inov

aNDDS

LUPIN

Global Tenders

GTB

Enoxaparin Sodium…

Branded Generics

Urban

Advanced Markets

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 18 ANDAs filed taking total ANDAs to over 35

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

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

Robust pipeline

Country Submissions

during the year

Total submissions

US 18 37

EU 9 11

France 2 2

Australia/ NZ 9 11

RoW 346 1107

India Region

India Region Formulations• Growing at 24% vs 8% industry average

Contributed by CVS (57%), NSAIDS (38%) and Diabetology (174%)

• Anti-Asthma range launched in Aug 04, already number 2 in its segment and growing (126%)

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

• Lupinova driving foray into rural and less penetrated regions

• Top 10 brands

Odoxil 341 R-Cinex 316

AKT – 4 236 Cefaxone 185

Ceff 166 Tonact 148

AkuriT – 4 147 L-Cin* 127

R- Cin 121 Ramistar 119

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

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%

API & Intermediates

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

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

Research & Development

R&D at Lupin• Over 300 scientists

– Actively engaged in: Process Improvement/ Formulation Development/NCE/ NDDS

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

• Filings in last year– US: ANDAs: 18– EU: MAAs: 11– ANZ: Dossiers: 9– Other: Dossiers: 346– DMFs/EDMFs/COS:41

• Going Forward– NDDS– Paediatrics range– Patented Technology platforms– Products for paediatric pipeline

R&D at Lupin

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

– Anti Migraine - In Phase II

– Anti Psoriasis (Chemical) - Entering Phase II

– Anti TB - In Phase I

Patents

Patents Issued, Allowed & Pending302

Issued, Allowed 71

Pending231

US14

EU

RoW47

EU10

US31

EU18

RoW182

Business Update

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

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%

2004-05

Exports45%

Domestic55%

Geographical Coverage

Exports46%

Domestic54%

2005-06

2004-05

FD45%

API55%

API vs FD

FD55%

API45%

2005-06

Lupin’s Facilities

Manufacturing

Research Center

Goa

Pune

Tarapur

Ankleshwar

Mandideep

Aurangabad

Jammu

LOCATION 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

Year 2006-07 and Beyond

Lupin Going Forward

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

Lupin Going Forward

Explore New Therapies/ Business Segments:

• Therapeutic Areas Oncology Dermatology

• Business Segments Biosimilars CRAMS

Thank you