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1 Cadila Healthcare Ltd Presentation at “Global Generic Pharmaceutical Conference 2006” Mumbai March 8, 2006 Presentation by : Ganesh Nayak, ED

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Page 1: 1 Cadila Healthcare Ltd Presentation at “Global Generic Pharmaceutical Conference 2006” Mumbai March 8, 2006 Presentation by : Ganesh Nayak, ED

1

Cadila Healthcare Ltd

Presentation at“Global Generic

Pharmaceutical Conference 2006”

MumbaiMarch 8, 2006

Presentation by : Ganesh Nayak, ED

Page 2: 1 Cadila Healthcare Ltd Presentation at “Global Generic Pharmaceutical Conference 2006” Mumbai March 8, 2006 Presentation by : Ganesh Nayak, ED

2

Zydus Cadila- One of India’s leading integrated pharma companies

Ranked 5th in the domestic formulation market. (as per ORG IMS MAT Dec-05)

Formulations exports grew by ~35% in last three years and by 102% in current year (upto Dec-05).

Rapid growth in the developed generic markets (US, France and Brazil), which will further accelerate formulations exports growth.

Leveraging strengths through contract manufacturing.

Consolidated revenues of US$ 300mn, PAT US$28mn and market capitalization of U$0.7b.

Page 3: 1 Cadila Healthcare Ltd Presentation at “Global Generic Pharmaceutical Conference 2006” Mumbai March 8, 2006 Presentation by : Ganesh Nayak, ED

3

Core business areas

Research & Development

Contract manufacturing

Emergingmarkets

High end APIs +intermediates

Developed generic markets

Domestic dosage forms

Revenue break up by segment Revenue break up by region

Based on Apr-Dec 05

Page 4: 1 Cadila Healthcare Ltd Presentation at “Global Generic Pharmaceutical Conference 2006” Mumbai March 8, 2006 Presentation by : Ganesh Nayak, ED

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Facilities and infrastructure

Formulations Dosage forms CertificationMoraiya (Ahmedabad) Tablets, Soft & hard gel capsules,

Metered dose inhalers, Dry powder inhalers, Injectibles, Lyophilised vials, Trans dermal patches and Vaccines

US FDA (for tablets), MHRA, Anvisa , AFSSAPS, BFAD, MCC

Baddi ( Himachal Pradesh) Tablets and capsules GMP

Goa Orals,injectables and suppositories

GMP

Bulk Drugs & Fine Chemicals Type

Ankleshwar (Gujarat) - API Multi-purpose US FDA

Vadodara (Gujarat) - API Partially dedicated US FDA

Patalganga ( Maharashtra) - API Multi-purpose GMP

Ahmedabad (Gujarat) - Fine Chem Fully dedicated

Contract manufacturing

New Mumbai ( Zydus Altana JV- pantoprazole intermediates)

Dedicated facility GMP

Manufacturing facilities

Page 5: 1 Cadila Healthcare Ltd Presentation at “Global Generic Pharmaceutical Conference 2006” Mumbai March 8, 2006 Presentation by : Ganesh Nayak, ED

5

Overall strategy

Continued focus on domestic market

Grow rapidly in key global generics

markets- US, Europe & Latin America

Leverage strengths through contract

manufacturing opportunities

Focus on innovation- R&D

Page 6: 1 Cadila Healthcare Ltd Presentation at “Global Generic Pharmaceutical Conference 2006” Mumbai March 8, 2006 Presentation by : Ganesh Nayak, ED

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Domestic formulations market

Source : ORG IMS MAT Dec-05

Top 10 Indian Companies

Value (Rs. B.)

%

TOTAL MARKET 230.4 1 GLAXOSMITHKLINE 13.0 5.66%2 CIPLA 11.8 5.11%3 RANBAXY 11.3 4.91%4 NICHOLAS PIRAMAL 10.1 4.36%5 ZYDUS CADILA 8.2 3.54%6 SUN PHARMA 7.5 3.27%7 ALKEM LABORATORIES 6.9 2.98%8 PFIZER 6.2 2.69%9 SANOFI AVENTIS 5.6 2.41%

10 ARISTO PHARMA 5.5 2.37%

# Name of the co.Market Share

• As evident from the list, the Indian formulations market is very fragmented, with top company accounting for less than 6% share.

• However, considering the current scenario, the possibility of consolidation within top rung companies seems less, since right now they are more interested in having their base in US and EU markets through acquisitions.

• However, we might see some consolidation happening within mid sized and small companies - either some of them get merged or get acquired by any MNCs, who are keen on setting up their base in India, or to strengthen it if they already have, to get maximum out of “India Cost Advantage”

Page 7: 1 Cadila Healthcare Ltd Presentation at “Global Generic Pharmaceutical Conference 2006” Mumbai March 8, 2006 Presentation by : Ganesh Nayak, ED

7

Domestic market strategy

• Maintain overall position and market share through:– Focus on faster growing chronic/ lifestyle segments.– Continued new product introductions.– In-licensing arrangements- Schering AG, Boehringer

Ingelheim, Bio Sidus, Viatris etc.– Marketing excellence.

2000-01 2004-05Portfolio shift to life style and chronic segments

Page 8: 1 Cadila Healthcare Ltd Presentation at “Global Generic Pharmaceutical Conference 2006” Mumbai March 8, 2006 Presentation by : Ganesh Nayak, ED

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Achievements in domestic market

Zydus Cadila ranks 5th with Rs ~8bn sales in domestic formulations market.

Large sales force and 7 specialty divisions servicing ~ 0.15 m doctors or about 60% doctors in the country.

No. 1 in high growth segments like Cardiovascular, Gastrointestinal and Female Healthcare; No. 2 in Respiratory.

12 Zydus brands feature amongst the top 300 brands.

Top 3 brands have > 25% Market Share, and out of the top 20 brands, 17 brands have > 10% Market Share.

Featured in top launches every year - Penegra, Pantodac, Mifegest, and now Nucoxia, adjudged best launch of 2004-05 (as per ORG IMS).

Recently restructured marketing divisions to increase participated market size and enhance presence in specialty and high growth segments.

Page 9: 1 Cadila Healthcare Ltd Presentation at “Global Generic Pharmaceutical Conference 2006” Mumbai March 8, 2006 Presentation by : Ganesh Nayak, ED

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International business- two fold focus

Developed generics markets• US- the largest generic market in the

world• Zydus Pharmaceuticals (USA) - for

formulations• Zydus Healthcare (USA) - for APIs

• Europe- Zydus France SAS• Spain, Italy ( planning to enter)

Emerging markets

• CIS - Russia , Ukraine

• Asia Pacific- Sri Lanka, Vietnam, Myanmar

• Africa, Middle East

• Brazil, South America

50

9

13

Formulations-emergingmarkets

Formulations- developedmarkets

60

200

110

APIs/intermediates- exports

2004-5 US$ 72 mn 2010E US$ 370

mn

International sales projection

Page 10: 1 Cadila Healthcare Ltd Presentation at “Global Generic Pharmaceutical Conference 2006” Mumbai March 8, 2006 Presentation by : Ganesh Nayak, ED

10

US - the key market

Product selection ~60 products prioritized Products include

existing generics, would-be generics including

block busters NDDS based

Transactional excellence Strong team- experienced in

US generics market Customised solutions Focus on high service levels

Unique distribution Tie up with Mallinkrodt for

distribution in US Sell under joint label Share revenues and profits Select customers- service

directly

Cost excellence through backward integration

Significant proportion of own APIs

API and FDF facilities in India with US cGMP quality control

Key factors affecting success in USand our initiatives so far

Page 11: 1 Cadila Healthcare Ltd Presentation at “Global Generic Pharmaceutical Conference 2006” Mumbai March 8, 2006 Presentation by : Ganesh Nayak, ED

11

US - robust filings

30 ANDAs represent ~ US$ 20b in current market size.

ANDAs filed- half for matured products. Include 6 blockbusters and 2 NDDS.

Half the products envisage own API.

Current status of filings Filed 30 ANDAs and 35 DMFs so

far.

Received 11 product approvals, of which 5 have been launched.

Plan to file 6-8 more ANDAs by the end of FY ‘06, taking total to 12-14 ANDAs for FY ‘06.

Atenolol (L)

Clindamycin

Metformin (3 ANDAs) (1-L)

Divalproex sodium DR

Ribavirin Tabs. & Caps. (2 ANDAs) (L)

Promethazine Tabs. (L)

Gatifloxacin Tabs.

Sertraline HCL Tabs.

Product Approvals by USFDA

(L) = Launched

19

11

30

35

0 5 10 15 20 25 30 35

ANDAs pendingapproval

ANDA approvals

ANDA filings

DMF filings

Page 12: 1 Cadila Healthcare Ltd Presentation at “Global Generic Pharmaceutical Conference 2006” Mumbai March 8, 2006 Presentation by : Ganesh Nayak, ED

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US - marketing plan

Marketing and distribution through Mallinckrodt, which is 7th largest generic player in US.

Also doing direct marketing through own US subsidiary.

Launched 5 products in 2005. Response has been excellent with initial market share > 10% in all products.

Plan to launch another 12-15 products in 2006.

Aggregate current market size of branded products of these ~ 20 products is ~ US$ 15b.

Expect to multiply sales in 2006 even as pricing pressure continues

Page 13: 1 Cadila Healthcare Ltd Presentation at “Global Generic Pharmaceutical Conference 2006” Mumbai March 8, 2006 Presentation by : Ganesh Nayak, ED

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France- first step in Europe

4.95.7

10.5

0

2

4

6

8

10

12

Sales (mn Euro)

CY2003 CY2004 CY2005E

Generics to drive our French business

804

592

809731

0

100

200

300

400

500

600

700

800

900

Patent expiries (mn Euro)

2004 2005 2006 2007

Major patent expiries in France ~US $ 2bn generics market, grew by

29% in 2004 (Source IMS)

~40 major drugs going off patent in France during 2004-7.Aggregate current size ~3bn Euro

Expected to drive ~ 20% per annum growth in the generics market

Branded generics business

Launched pure generics

Export business

Business thru a large buying group with whom agreement is likely to be signed soon.

French business segments

Page 14: 1 Cadila Healthcare Ltd Presentation at “Global Generic Pharmaceutical Conference 2006” Mumbai March 8, 2006 Presentation by : Ganesh Nayak, ED

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Key initiatives for France

Launch of generics Launched 76 generic

presentations so far. Plan to boost the basket

to ~ 85 presentations by end 2006

Leveraging India’s low cost

New product filings- first approval received in 05-06, more in pipeline

Site variation- current 3 filings, 2 approvals

8

56

7685

0

10

20

30

40

50

60

70

80

90

Generics products- cumulative

CY2003 CY2004 CY2005 CY2006E

1

7

2 3

0

1

2

3

4

5

6

7

New product filingsfrom India

Site variation filings

2004-5 2005-6 E

Relationship with

pharmacists Building special

relationship with pharmacists

Supporting a health awareness program for the Zydus club of pharmacists

Page 15: 1 Cadila Healthcare Ltd Presentation at “Global Generic Pharmaceutical Conference 2006” Mumbai March 8, 2006 Presentation by : Ganesh Nayak, ED

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International business- new markets

Brazil Generics market size of ~US$0.5b Received 13 generic product

approvals, of which 10 products have been launched so far.

Plan to increase basket to 11 products in 2005-6

Plan to file for and launch 10-12 products every year

Spain/ Italy

Low generics penetration, high growth

Looking for suitable entry opportunity

South Africa Branded generics- commenced

operations

Marketing and distribution partner finalized

Received 5 product approvals so far

Plan to launch 4-5 products in 2005-6, 8 in 2006-7

Page 16: 1 Cadila Healthcare Ltd Presentation at “Global Generic Pharmaceutical Conference 2006” Mumbai March 8, 2006 Presentation by : Ganesh Nayak, ED

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World class state of the art manufacturing facilities -

Finished dosage formulations plant at Moraiya with approvals from USFDA, AFSSAPS, ANVISA, MHRA, MCC (capacities in all forms except tablet dept. is available.)

Two API plants (300 KL) with approval from USFDA

Dedicated dossier filing and IPR team, enabling rapidity in site transfer projects and competency in development projects

Zydus’ experience with global partners -

Cost efficient and high quality products and services

Working with several US and European multinationals

Operational transparency with these partners

Dedicated project management teams

Contract manufacturing - exciting prospects

Page 17: 1 Cadila Healthcare Ltd Presentation at “Global Generic Pharmaceutical Conference 2006” Mumbai March 8, 2006 Presentation by : Ganesh Nayak, ED

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Altana JV - benchmark in contract manufacturing

State of the art manufacturing facility set up as an EOU near Mumbai.

Supplying 2 key starting materials of Pantoprazole to its worldwide patent holder, Altana AG, Germany.

60% of global requirements are met from this plant.

Recently increased capacity by 20% from 48 tons to 60 tons.

Mayne Pharma (Australia) - JV for oncology injectibles (Generics)

Setting up an integrated cytotoxic facility located in an SEZ near Ahmedabad.

Construction of the plant in full swing now.

Commercial production expected in FY08.

Full capacity utilisation in FY09.

11 other contracts with big innovator and generic MNCs signed so far with peak revenue potential of US$ 23.6 Mio.

Few more contracts in Pipeline.

Contract manufacturing - achievements so far

Page 18: 1 Cadila Healthcare Ltd Presentation at “Global Generic Pharmaceutical Conference 2006” Mumbai March 8, 2006 Presentation by : Ganesh Nayak, ED

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Research - investing for the future

R& D pipeline• Phase I clinical trials of ZYH1, our first

IND, completed successfully.• Phase II trials to start in 2006-7.• Second IND (ZYI1) filed in Q3 05-06,

which will go for clinical trials soon.• Expect to file one more IND in next

financial year.• 2 more molecules in pre-clinical stage.

State of art R&D center Rich talent pool -technical

strength >230 Developed infrastructure for

pre-clinical research and development

R&D expense- projected at 6-7% of sales

4.80%

5.60%

4.40%

4.60%

4.80%

5.00%

5.20%

5.40%

5.60%

2003-4 2004-5

NCE Pre Clinical Phase 1 Phase 2 Phase 3

ZYH1 Dyslipidemia

R & D % to Sales

ZYH2

ZY01

Diabetes

Obesity

ZYI1 Inflammation Phase I Clinical trial to start soon

Page 19: 1 Cadila Healthcare Ltd Presentation at “Global Generic Pharmaceutical Conference 2006” Mumbai March 8, 2006 Presentation by : Ganesh Nayak, ED

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Set up a JV with M/s Bharat Serum and Vaccines Ltd., one of the top 10 biotech companies in India, to develop, manufacture and market a non-infringing and proprietary Novel Drug Delivery System (NDDS) of an approved anti-cancer product for global markets.

Got first approval from French regulatory authority, AFSSAPS for new product Sertraline Caps. Supply to France from our Moraiya plant has also commenced with Paracetamol.

Recent Developments

Page 20: 1 Cadila Healthcare Ltd Presentation at “Global Generic Pharmaceutical Conference 2006” Mumbai March 8, 2006 Presentation by : Ganesh Nayak, ED

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Summary of Growth drivers

Short-term < 2 years

Short-term < 2 years

Medium-term 2-5 years

Medium-term 2-5 years

Long-term >5 years

Long-term >5 years

Capitalise on existing strengths to drive growth in domestic market

Regulated generics markets – APIs and formulations in Europe and USA

Expand business in regulated generic markets- organically /inorganically

In-licensing and out-licensing

Contract manufacturing, in-sourcing and leveraging on alliances

Innovation- research driven (NCE and NDDS) global pharma company

Page 21: 1 Cadila Healthcare Ltd Presentation at “Global Generic Pharmaceutical Conference 2006” Mumbai March 8, 2006 Presentation by : Ganesh Nayak, ED

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Leveraging the India advantage

Contract manufacturing-lower cost manufacturing

R&D- phase I /IIa clinical trials in India

US - regulatory filings + formulation manufacturing base in India + high level backward integration

France- Shift manufacture to India gradually through site variation/new filings

Bio-equivalence studies- potential to carry out in India

Page 22: 1 Cadila Healthcare Ltd Presentation at “Global Generic Pharmaceutical Conference 2006” Mumbai March 8, 2006 Presentation by : Ganesh Nayak, ED

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Financial Highlights

** Not Annualised.

Page 23: 1 Cadila Healthcare Ltd Presentation at “Global Generic Pharmaceutical Conference 2006” Mumbai March 8, 2006 Presentation by : Ganesh Nayak, ED

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Our vision

One of India’s leading healthcare players, we

aim to be a global research driven company by

2020. We shall achieve sales of $400mn by

2006 and We shall be a top ten global generics

company with a strong R&D pipeline and sales

in excess of $ 1b by 2010

Page 24: 1 Cadila Healthcare Ltd Presentation at “Global Generic Pharmaceutical Conference 2006” Mumbai March 8, 2006 Presentation by : Ganesh Nayak, ED

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No part of this presentation may be reproduced, quoted or circulated without prior written approval from Cadila Healthcare Ltd..

This presentation may include certain “forward looking statements” , based on current expectations, within the meaning of applicable laws and regulations. Actual results may differ and the company does not guarantee realization of these statements.The Company also disclaims any obligation to revise any forward-looking statements . The viewers may use their own judgement and are advised to make their own calculations before deciding on any matter based on the information given herein

www.zyduscadila.com

Thank You.