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“Global Generic Pharmaceutical Conference 2006”

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Presentation on theme: "“Global Generic Pharmaceutical Conference 2006”"— Presentation transcript:

1 “Global Generic Pharmaceutical Conference 2006”
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.

3 Core business areas Domestic dosage forms High end APIs +
intermediates Emerging markets Developed generic markets Contract manufacturing Research & Development Revenue break up by segment Revenue break up by region Based on Apr-Dec 05

4 Facilities and infrastructure

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

6 Domestic formulations market
Top 10 Indian Companies 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” Source : ORG IMS MAT Dec-05

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. Portfolio shift to life style and chronic segments

8 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 (as per ORG IMS). Recently restructured marketing divisions to increase participated market size and enhance presence in specialty and high growth segments.

9 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 60 200 110 International sales projection Formulations-emerging markets Formulations- developed markets APIs/intermediates- exports US$ 72 mn 2010E US$ 370 mn

10 Key factors affecting success in US and our initiatives so far
US - the key market Key factors affecting success in US and our initiatives so far Product selection ~60 products prioritized Products include existing generics, would-be generics including block busters NDDS based Cost excellence through backward integration Significant proportion of own APIs API and FDF facilities in India with US cGMP quality control 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

11 Current status of filings
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. Product Approvals by USFDA 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. 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 ANDAs for FY ‘06. (L) = Launched

12 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 Response has been excellent with initial market share > 10% in all products. Plan to launch another 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

13 Major patent expiries in France Generics to drive our French business
France- first step in Europe 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 Aggregate current size ~3bn Euro Expected to drive ~ 20% per annum growth in the generics market Generics to drive our French business French business segments Branded generics business Launched pure generics Export business Business thru a large buying group with whom agreement is likely to be signed soon.

14 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 Relationship with pharmacists Building special relationship with pharmacists Supporting a health awareness program for the Zydus club of pharmacists

15 International business- new markets
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 , 8 in 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 Plan to file for and launch products every year

16 Contract manufacturing - exciting prospects
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

17 Contract manufacturing - achievements so far
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.

18 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 Second IND (ZYI1) filed in Q , 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 R & D % to Sales NCE Pre Clinical Phase 1 Phase 2 Phase 3 ZYH1 Dyslipidemia ZYI1 Inflammation Phase I Clinical trial to start soon ZYH2 ZY01 Diabetes Obesity

19 Recent Developments 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.

20 Summary of Growth drivers
Long-term >5 years Medium-term 2-5 years Short-term < 2 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

21 Leveraging the India advantage
US - regulatory filings + formulation manufacturing base in India + high level backward integration France- Shift manufacture to India gradually through site variation/new filings Contract manufacturing-lower cost manufacturing R&D- phase I /IIa clinical trials in India Bio-equivalence studies- potential to carry out in India

22 Financial Highlights ** Not Annualised.

23 Our vision One of India’s leading healthcare players, we aim to be a global research driven company by 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

24 Thank You.
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

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