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1
Cadila Healthcare Ltd
Investor PresentationOctober 2006
2
Zydus Cadila- One of India’s leading integrated pharma companies
Ranked 5th in the domestic formulation market. (as per ORG IMS MAT Sep-06).
Formulations exports grew by ~35% in last three years and by 114% in last year.
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 (FY 05-06) of US$335 mn, PAT of US$34 mn and market cap. of ~US$ 900 mn.
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
For FY 05-06 Rs. 15 bn. ($ 335 mn)
4
Facilities and infrastructure
Formulations Dosage forms Certification
Moraiya (Ahmedabad)
Tablets, Soft & hard gel capsules, Metered dose inhalers, Dry powder inhalers, Injectibles, Lyophilised vials, Transdermal 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 Certification
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 Type Certification
New Mumbai (Zydus Altana JV- pantoprazole intermediates)
Dedicated facility GMP
Goa (Madaus - for Agiolax) Dedicated facilityWHO, GMP, BaFD, ANVISA
One more formulations facility in a tax free zone and an integrated cytotoxic facility for Zydus Mayne JV in SEZ are under construction.
Initial formalities for new facility (in SEZ) for JV w ith BSV to manufacture anti cancer product (NDDS) have also been completed.
5
Distinctive capabilities in manufacturing and distribution
Moraiya- largest facility in Asia - capable of producing 3 bn tablets/pa (single shift)
Amongst the few in India to make Lypholised products Vaccines Aerosols Hormones Cytotoxic products
Only producer in India Transdermal patches Suppositories
Country wide distribution Large sales force and 7
specialty divisions Servicing ~0.15m doctors
or about 60% doctors in the country
Capability for cold chain products
Distributing high-end in-licensed products
Manufacturing Distribution
6
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
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, Meda Pharma etc.– Marketing excellence
2000-01 2005-06Portfolio shift to life style and chronic segments
8
Achievements in domestic market
• Zydus Cadila ranks 5th with Rs ~8bn sales. (Source : ORG IMS MAT Sep-06)
• 14 Zydus brands feature amongst the top 300 brands. (as per ORG IMS MAT Sep-06)
• Top 3 brands have > 25% MS, and out of the top 20 brands, 17 brands have > 10% MS. (Source : ORG IMS MAT Sep-06)
• Launched 34 new products in FY 05-06. New products introduced in last 3 years contribute ~10% of domestic formulations sales.
• Featured in top launches every year - Penegra, Pantodac, Mifegest, and now Nucoxia, adjudged best launch of 2004-05.
• Plan to launch over 35 products in FY 06-07 also. Recently launched ‘Novolizer’, a third-generation refillable, breath actuated multiple dose dry powder inhaler device for Asthma and COPD. The technology for the device has been provided by Meda Pharma of Sweden.
• Launched “Project Phoenix” for -
• Strengthening pillar brands• Rejuvenating mature brands• Enhancing product management skills• Improving business health
• Recently restructured marketing divisions to increase participated market share and enhance presence in specialty and high growth segments.
9
Top rankings in key therapeutic areas
CardiovascularCardiovascular
GastrointestinalGastrointestinal
Female HealthcareFemale Healthcare
RespiratoryRespiratory
11
11
11
22
* Segment ranking and Market Share refer to participated market Source:ORG-IMS Jun 06 (MAT)
Zydus Rank *
Zydus MS *
10.7%10.7%
Segment MS *
Segment growth *
9.1%9.1%
5.8%5.8%
4.4%4.4%
14.1%14.1%
18.9%18.9%
15.7%15.7%
11.7%11.7%
7.0%7.0%
6.0%6.0%
8.3%8.3%
7.7%7.7%
27,00727,007
Participated Segment Value
(Rs. Mio)
22,93922,939
14,72314,723
11,15111,151
10
International business- two fold focus
Developed generics markets• US- the largest generic market in the
world• Zydus Pharmaceuticals Inc. - for
formulations• Zydus Healthcare LLC - 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
19
25
39
Formulations-emergingmarkets
Formulations- developedmarkets
APIs/intermediates- exports
2005-06 US$ 83 mn 2010E US$ 370 mn
International sales projection 60
200110
11
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
12
US - robust filings
Filed 41 ANDAs and 45 DMFs so far.
41 ANDAs represent ~ US$ 21b in current market size.
Received 17 product approvals, of which 7 have been launched.
ANDAs filed- half for matured products. Include 6 blockbusters and 2 NDDS.
Half the products envisage own API.
Plan to file 10-12 more ANDAs by the end of FY 06-07, taking cumulative total to over 50 ANDAs.
24
17
41
45
0 5 10 15 20 25 30 35 40 45
ANDAs pendingapproval
ANDA approvals
ANDA filings
DMF filings
13
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 7 products so far. Response has been excellent with initial market share > 10% in all products.
Sales in first year (FY 05-06) ~ US$ 11 mn., operations were profitable in the very first year.
Plan to launch another 6-8 products in FY 06-07.
Aggregate current market size of branded products of these ~ 15 products is ~ US$ 11b.
Expect to multiply sales in FY 06-07 even as pricing pressure continues
14
France- first step in Europe
4.95.7
10.5
Sales (mn Euro)
CY2003 CY2004 CY2005
Generics to drive our French business
804
592
809731
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
Pure generics
Business thru “Evolupharm”, a large buying group representing ~ 2250 pharmacies.
Exports business
Branded business, which has been sold off recently, to have total focus on generics
French business segments
15
Key initiatives for France
Launch of generics Launched over 85
generic presentations so far.
Plan to boost the basket to ~ 90 presentations by end 2006
Leveraging India’s low cost
New product filings- first approval received in 05-06, more in pipeline
Site variation- current 12 filings, 4 approvals
8
56
76
90
0
10
20
30
40
50
60
70
80
90
Generics products- cumulative
CY2003 CY2004 CY2005 CY2006E
15
1
12
4
0
2
4
6
8
10
12
14
16
New product filingsfrom India
Site variation filings
Filed Approved
Relationship with
pharmacists Building special
relationship with pharmacists
Supporting a health awareness program for the Zydus club of pharmacists
16
International business- new markets
Brazil Pharma market size of ~US$7 bn.,
growing at ~18% (Source : ESPICOM) Filed 26 pure & branded generics
dossiers Received 13 generic product
approvals, and all have been launched.
Plan to file for and launch 8-10 products every year
Spain/ Italy Low generics penetration, high
growth
Looking for suitable entry opportunity
South Africa Branded generics- commenced
operations
Marketing and distribution partner finalized
Filed 33 submissions, received 10 product approvals so far
Launched 3 products in 05-06, plan to launch 6-8 products in 06-07
17
Zydus is uniquely positioned on Contract Mfg. Front :
World class state of the art manufacturing facilities.
Dedicated dossier filing and IPR team, enabling rapidity in site transfer projects and competency in development projects.
Zydus’ experience with global partners -
Cost efficient and high quality products and services
Working with several US and European multinationals
Operational transparency with these partners
Dedicated project management teams
Contract manufacturing - exciting prospects
18
Altana JV - benchmark in contract manufacturing.
State of the art manufacturing facility set up as an EOU near Mumbai.
Supplying 2 key starting materials of Pantoprazole to its worldwide patent holder, Altana AG, Germany.
60% of global requirements are met from this plant.
Recently increased capacity by 20% from 48 tons to 60 tons.
Mayne Pharma (Australia) - JV for oncology injectibles (Generics).
Setting up an integrated cytotoxic facility located in an SEZ near Ahmedabad.
Construction of the plant in full swing now.
Commercial production expected in FY 07-08.
Full capacity utilisation in FY 08-09.
17 other contracts with big innovator and generic MNCs signed so far with peak revenue potential of US$ 25.5 Mio.
Few more contracts in pipeline.
Contract manufacturing - achievements so far
19
Research Focus
Zydus Research Centre (ZRC)
Located in Ahmedabad
Focused on NME Research
Pharmaceutical Technology Centre (PTC)
Located in Ahmedabad
Focused on Finished Dosage Form Development
API Process Research
Located in Ankleshwar/Ahmedabad
Focused on Process research
Revenue R&D Spends - FY ’06
Scientific Talent Pool ~ 600
250
100
250
NME & DrugDiscovery
Generics /Developmental
API & Others
23780
479
NME & DrugDiscovery
Generics /Developmental
API & Others
60%
10%30%
Rs. 797 Mio. (5.5% of net sales)
20
Zydus Research Center - investing for the future
• NME Research & Biologicals (Biogenerics).
• Therapeutic Area: Diabetes, Dyslipidemia, Obesity, Inflammation.
• Infrastructure for target identification to pre-clinical research / early clinical development.
• Lead lipid lowering drug candidate ZYH1 in Phase II clinical trials.
• ZYI1, the Anti-inflammatory & Pain Management compound, completed Phase I trials, while ZYH2, the novel agent for treating diabetes will start Phase I clinical trials soon.
• Multiple candidates under preclinical stage.
NME IND Filing Phase 1 Phase 2 Phase 3
ZYH1 Dyslipidemia
ZYH2
ZY01
Diabetes
Obesity
ZYI1 Inflammation
Pre Clinical
NME Pipeline
21
PTC – New Product Development Team
• Product Development team of 250 scientists
• Infrastructure:
– Development labs
– Pilot Plant
– Analytical Support
– Stability studies
– Pharmacokinetics
• In-house Regulatory, IPR & Packaging development Group
PTC : Scientific Team
80
10
115
25
155
Formulations DevelopmentAnalytical Development
Pharmacokinetics & Project Mgmt.Regulatory Affairs
IPRPackaging Development
22
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.
Acquired ~ 62% stake in Carnation Nutra-Analogue Foods Ltd., the manufacturers of “Nutralite”, India’s largest selling margarine, currently enjoying a market share close to 60%, which is free from cholesterol and is healthier substitute for butter. This will complement our “Sugar Free”, which is brand leader in life style segment.
Opened up a new subsidiary in Japan - "Zydus Pharma Inc., Japan" to kick start Japanese operations. The subsidiary will market APIs and formulations in Japanese market, and start product registration process in 2007.
Recent Developments
23
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 manufacturing to India gradually through site variation & new filings
Bio-equivalence studies : potential to carry out in India
24
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
25
Financial Highlights
26
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
27
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.