CRAMS INDIA : OVERVIEW & OUTLOOK

June 2011

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CRAMS INDIA

June 2011

Agenda: CRAMS Overview & Outlook

Description Global Growth Drivers Slide 3-6

Market Dynamics
Outsourcing Trends Contract Manufacturing Outsourcing Contract Research Outsourcing

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8 9-11 12-13

Key Challenges
Key Players -Divis Lab -Dishman Pharma -Jubilant Lifesciences -Piramal Healthcare -Biocon Limited

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15 16 17 18 19

Outlook & Conclusion

Annexure Analysts Contact
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CRAMS Global Growth Drivers

Patent Expiries
Drugs worth US$ 97 billion expected to go off patent from 2011-15 in US compared to USS$73 billion during 2006-10 period New launches not enough to justify loss of existing block-buster going off patent Sales generated by new approvals have seen declining trend over the last few years despite increase in R&D budgets Average R&D cost increased to US$1.3 billion per NME; rising intolerance to side effects of new drugs reduces research productivity Increasing role of Generics being played out in developed countries by Insurance and healthcare providers Foray into branded generics segment of emerging markets to boost dwindling global revenues and profitability

Falling R&D Productivity

Focus on Generics / Branded Generics

Cost Pressures

Falling R&D productivity coupled with pricing pressure has led to margin contraction Increase in raw material and wage inflation further impact bottomline

STRONG GROWTH PROSPECTS FOR GLOBAL CRAMS INDUSTRY BACKED BY COST PRESSURES for INNOVATIVE PHARMA COMPANIES AND INCREASING GENERICISATION
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CRAMS Global Growth Drivers

New FDA approvals and R&D Spending by Year (2001-2010)
$80.0 $70.0 $60.0 $50.0 $40.0 $30.0 $20.0 $10.0 $0.0 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 $29.5 17 $30.8 24 21 $33.0 $47.6 20 $51.8 22 18 36 $63.2 $56.1 24 40

$63.7
26

$65.9

$67.4

35 30 25

21

20 15 10 5 0

R&D spend (LHS)

No. of New drugs (RHS)

US: Patent Expiries Schedule

40 35 30 US$ billion 25 20 15 35.4 15.2 15.4 15.7 14.7 19.3 15.6

10
5 0 2006 12.4

14

12.5

2007

2008

2009

2010

2011E

2012E

2013E

2014E

2015E

Source: USFDA, PhRMA Industry Profile 2011, Industry reports, ICRA estimates.

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CRAMS Global Growth Drivers

Patent Expiries: Selected Products Product Xalatan Company Pfizer Yearly Sales ($Billion) 1.7 Year of Patent Expiry 2011

Leavaquin Zyprexa Diovan (ex-US) Aricept (Japan)

Taxotere Concerta Lipitor Singulair Seroquel Provogil Geodon Tricor Eloxatin Viagra Lexapro Plavix (US) Diovan (US) Enbrel (US) Actos

Johnson & Johnson Eli Lilly Novartis Eisai

Sanofi-aventis Johnson & Johnson Pfizer Merck&Co, Inc. AstraZeneca Cephalon Pfizer Abbott Sanofi-aventis Pfizer Forest labs Bristol-Myers/ Sanofi-aventis Novartis Amgen Takeda

1.6 5.0 3.5 1.0

1.2 1.5 10.7 4.7 4.9 1.1 1.3 1.3 1.4 1.9 2.8 6.7 2.5 3.3 4.1

2011 2011 2011 2011

2011 2011 2011 2012 2012 2012 2012 2012 2012 2012 2012 2012 2012 2012 2012

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CRAMS Global Growth Drivers

Patent Expiries: Selected Products Product Cymbalta Niaspan Lidoder Oxycontin Adavir Aciphex Company Yearly Sales ($Billion) Year of Patent Expiry Eli Lilly 3.1 2013 Abbott 1.1 2013 Endo 1.2 2013 Purdue Pharma 3.1 2013 GlaxoSmithKline 8.4 2013 Eisai 1.6 2013 Sanofi-aventis/BristolPlavix (ex-US) Myers 3.8 2013 Epogen Amgen 2.6 2013 Seretide/Advair GlaxoSmithKline 2.5 2013 Lyrica Pfizer 2.8 2013 Nexium AstraZeneca 5.0 2014 Copaxone Teva 2.8 2014 Celebrex Pfizer 2.4 2014 Blopress (Japan) Takeda 1.5 2014 Welchol Daiichi Sankyo 0.4 2015 Aggrenox Boehringer Ingelheim 0.4 2015 Aloxi Eisai 0.5 2015 Avodart GlaxoSmithKline 0.6 2015 Zyvox Pfizer 0.7 2015 Androgel Solvay 1.0 2015 Gleevac Novartis 1.3 2015 Namenda Forest Labs 1.3 2015 Source: ICRA research, Moodys, Industry Reports* Year generally reflect date that patents first begin to expire. Generic competition may not necessarily occur depending on many factors including strength of later patents, whether generics receive approval , status of patent challenges etc.

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CRAMS - Market Dynamics

Global CRAMS Market, US$ Billion
80 70 60 50 40 30 20 10 0

CAGR15%
15 29 2007 18 33 21 25

US$ Billion

Approximately 64% of global CRAMs market in manufacturing which intermediates for new manufacturing of APIs

the estimated US$ 67 billion 2010 is dominated by contract includes manufacturing of chemical entities (NCEs) or

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Contract Research predominantly consists of drug discovery, preclinical and clinical research and represent US$ 25 billion opportunity globally

2008

2009

2010E

Contract Manufacturing

Drug Discovery and Research

Huge scope for growth as currently only ~20% of global Pharma R&D spend is being outsourced
Out of the estimated US$3.8 billion market in 2010, approximately US$ 2.3 billion pertains to contract manufacturing. Chemical synthesis being the major contributor followed by formulations & packaging Contract research market size at US$ 1.5 billion displaying strong growth driven by chemistry capabilities, skilled manpower and cost value proposition Players in the Indian CRO market in the year 2005 were ~20, which increased to ~100 in 2008 and expected to be around 150-200 by 2012 leading to higher competitive intensity
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Indian CRAMS Market, US$ Billion

4 3.5 3 2.5 2 1.5 1 0.5 0 1.5 0.9 0.6 0.3 0.8 2007 1.1 2008 1.6 2.3

US$ Billion

2009

2010E

Contract Manufacturing

Drug Discovery and Research

Source: Industry reports, ICRA estimates, excludes Clinical Trials

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CRAMS Outsourcing Trends

Extent of Outsourcing in each area of the value chain
60% 50% 40% 30% 20% 10% 0% Discovery API dev. Dosage dev. API mfg. Dosage mfg. Packaging 25% 15% 20% 15% 15% 55%

Over the past few years, Pharma MNCs have begun to outsource core functions such as clinical trials and manufacturing with drug discovery being one of the recent core functions to be out sourced Late life cycle outsourcing has the highest share with API manufacturing outsourcing the highest at around 55% While the Outsourcing of drug & discovery development activities and dosage manufacturing is low as they form part of core activities, they represent a huge scope for future growth as integrated CRAMS players emerge and build entrenched relationships with Pharma MNCs
Source: Industry reports, ICRA estimates.

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Contract Manufacturing (CMO)

Overview
Approximately 60% of the total US$2.3 billion Indian CMO market relates to chemical synthesis followed by formulation and packaging, which constitutes about 40%. The market has grown at a CAGR of 51% over 2007-10 reflecting upon the strong potential it has to offer Contract Manufacturing requires upfront investments for building up requisite facilities and is capital intensive in nature, thereby requiring long term assured supply contracts in order to recoup investments or take or pay type of contracts Indian players have taken in-organic route of acquisition to gain access to customers, regulated markets of America and Europe and niche technologies like sterile injectables, cytotoxics to build strong franchise for themselves

Growth Drivers
High Number of USFDA and UK MHRA approved plants (200+) Well-developed chemistry skills Sufficient product filing track record: Indian companies have been on the fore-front , both in terms of filing DMFs and ANDA Robust talent pool Low production & R&D cost Quality Infrastructure & established track record of IPR compliance
ICRA Limited DMF s Filings
1200 1000 800 600 400 200 0 2005 2006 2007 2008 2009 2010
% India (RHS) DMF Filed, India (LHS) DMF filed, Overall (LHS)

37%

39%

40%

40%

45%

37%

36%

40%

35%
30% 1131 736 271 760 294 1021 380 1024 365 25% 20% 455 15% 10%

799
321

Source: USFDA, ICRA estimates.

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Contract Manufacturing (CMO)

Number of FDA approved plants for sample countries
200
150 100 50 0

India*

Italy

China

Spain

Taiwan

Israel

Hungary

Overall Indexed manufacturing cost (US FDA approved plants)

120% 100% 80% 60% 40% 20% 0% Cost Index US Europe India 35-40% 100% 80-85%

Source: Industry Reports, ICRA estimates. Year 2006, *For India upto 2009

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Contract Manufacturing (CMO) Domestic Trends

Domestic branded business present an attractive opportunity for contract manufacturing as large domestic branded generic players focus on marketing and product management and outsource non-core activities like manufacturing to local players Focused manufacturing players tend to be more efficient in production as well as enjoy higher level of capacity utilization leading to lower cost of production In addition to above, Contract manufacturers enjoy several other cost advantages owing to economies of scale in procuring raw material coupled with exploiting tax breaks through setting up of facilities in such notified areas Large domestic capacity of contract manufacturer facilitate flexible outsourcing for outsourcing companies based on market demand. This helps them respond rapidly to events like new product launches (line extension etc.) or surge in demand for existing products Many contract manufacturers have also been able to develop new products (line extensions, combinations) proactively as added service to domestic majors. Further Novel Drug Delivery System applications owned by these contract manufacturers help re-launch existing products thereby leveraging its value proposition
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Contract Research Outsourcing (CRO)

Overview
Contract Research Organizations (CROs) provides services including drug discovery, new product development, formulation, pre-clinical trial management spanning till phase IIA The global contract research market reached at US$25 billion in 2010 growing at a CAGR of 19% during 2007-10. The Indian contract research industry has been growing tremendously over the past few years and reached approximately US$ 1.5 billion in 2010, a CAGR of 65% from 2007-10, albeit on a small base The Indian Pharmaceutical outsourcing providers have capabilities to provide late stage discovery (research chemistry) and drug development services. However they are in the process of building up research biology skills to facilitate early stage discovery

Growth Drivers
Low cost & time advantage
Cost of Clinical Studies Phase I Study Phase II Study Phase III Study US$ Million 20-25 50-60 100-110 India cost advantage <50% <60% <60%

Indian CRO market

Research Chemistry & biology 18%

Availability of diverse genetic pool Large resource of technical expertise Increasing compliance with WHO Good Clinical Practice (ICH-GCP)
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Pre-Clinical Trial 30%

Clinical Trials 52%

Source: Industry Reports, ICRA estimates CRAMS INDIA 12

Contract Research Outsourcing (CRO)

120 100 80 60 100 40 20 0 35-40 25

Potential savings in outsourcing end-to-end research and development to India

8-9 20-25

Potential cost savings of ~60%

Total R&D cost in US

Research biology

Research chemistry

Development cost

Total R&D cost in Idnia

KEY GOVERNMENT INITIATIVES IN THE LAST FEW YEARS Objective Key Initiative undertaken Promoting collaboration among industry, academia and government through various programmes such as Collaboration between industry,the New Millennium Indian Technology leadership (NMITLI) and Drugs and Pharmaceuticals Research academia and the government Program Focus on specialised The GoI has set up seven NIPERs as institutes of "national importance" to achieve excellence in pharmaceuticals education pharmaceutical sciences and technologies, education and training Duty relief for technology The GoI has also introduced zero duty for technology upgrades in the pharmaceutical sector through the upgrades Export Promotion Capital Goods Scheme (EPCG) scheme Promotion of Indian drug Public Private partnership model to harness India's innovation capability through 50% public funding. discovery platforms Targeting to achieve one out of every five to ten drugs discovered worldwide by 2020 originating from India. Increase in weighted reduction from 150% to 200% on expenditure incurred on in-house R&D activities and Tax Exemption from 125% to 175% on activities outsourced to specific institutions Source: Industry, ICRA research ICRA Limited CRAMS INDIA 13

Key Challenges for Indian CRAMS Industry

Cost Escalation & Talent attrition
Unavailability of skilled manpower for conducting clinical trials CRAMs being a skill-intensive business with high gestation period, attrition of skilled work force is a high risk for the company leading to high compensation structure Concerns on diligent follow of guidelines issued by regulatory bodies Concerns on sharing details regarding NCE for want of proper regulatory framework and risk management framework

Regulatory Issues

Captive CROs & intensifying competition

High level of new entrants despite high level of entry barriers owing to attractive long term opportunity In order to cut costs, many MNCs having presence in India are outsourcing work to captive CROs in Indian
China emerging as a strong contender for CMO business on account of cost competitiveness, though India has a lead over China in terms of manufacturing facilities and Language skills Improving IPR compliance through alliances/acquisitions by global CROs

Competition from China

ESTABLISHING RELATIONSHIPS AND TRUST WITH INNOVATOR AND OTHER PHARMA MAJORS TOGETHER WITH PROPER RISK MANAGEMENT FRAMEWORK CRITICAL TO MITIGATE RISKS
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Key Players Divis Lab

Business Overview
One of the largest CRAMS players - custom synthesis of active ingredients for innovator companies, other specialty chemicals like peptides & nutraceuticals. CRAMS contributing 50% of the turnover while the remaining from manufacture of Generic APIs US FDA approved facility, with 38 DMF filings and 10 Certificate of Suitability with European directorate Relatively high product concentration with top product accounting for 18% of sale and top 5 products accounting for 55% of the sales Established relationship with innovator companies; top 5 companies accounting for 49% of the revenues Exports constitute 91% of the revenues, thereby exposing it to foreign exchange fluctuations

Financials
Performance summary Divis Labs 1400 1200 1000 800 600 400 200 0 FY06 FY07 FY08 FY09 FY10 FY11 100% 80% 60% 40% 20% 0% -20% -40%

Operating Income (LHS) OPBDIT Margin (RHS)

OI Growth (RHS) PAT Margin (RHS)

Source: Industry Reports, ICRA estimates. Rs. in crore

Strong growth over the years to cross peak turnover of Rs. 1200 crores during FY 2009. Decline in FY 2010 owing to de-stocking and inventory rationalisation by global pharma majors, recovery during FY11 Healthy margins and profitability coupled with moderate capex plans leading to consistent free cash flows Strong Balance Sheet with net cash position and investments to the tune of approximately Rs. 525 crores as on March 2011
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Key Players Dishman Pharma

Business Overview
Research driven company with expertise in chemical synthesis, manufacturing of APIs, API intermediates, quaternary compounds (Quats) & fine chemicals. Approximately 70% of the turnover from CRAMS Acquisition of Carbogen-Amcis (2006) has enabled the company to be present across the value chain of CRAMS & strengthen its position Entrenched relationship with Pharma MNCs with Solvay as the top customer contributing more than 15% of the revenues US FDA approved manufacturing facilities Exports constitute 90% of the revenues; majority to Europe

Financials
Performance summary Dishman Pharma
1200 1000 INR crores 120% 100% 80% 60% 40% 20% 0% -20% FY06 FY07 FY08 FY09 FY10 FY11

800
600 400 200 0

Operating Income (LHS) OPBDIT Margin (RHS)

Source: Annual Reports, ICRA estimates. Rs. in crore

OI Growth (RHS) PAT Margin (RHS)

Strong growth over the last few years through organic and in-organic route CRAMS business impacted by recessionary conditions prevailing in Europe coupled with Rupee appreciation against Euro leading to overall -1.3% growth 9M FY11 Execution of low-margin contracts lead to drop in operating margins Moderately leveraged balance sheet with D/E ratio of 1.0x as on March 2011 Notwithstanding short term challenges, long term prospects remaining attractive
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Key Players Jubilant Life Sciences Limited

Business Overview
Largest Indian CRAMS player with presence across the value chain from drug discovery research service to development, custom manufacturing (APIs, pyridines, sterile & non sterile products and radiology) Acquired Draxis Health Inc. in 2008, a Canada based contract manufacturing & radiopharmaceutical company for US$255 million and in June 2007 acquired Hollister Stier having contract manufacturing of sterile injectables. Acquisition to allow higher presence in regulated markets and on-shore presence Divested low margin Agri & Performance Polymers from FY11 business into a separate company to enhance business focus on Lifesciences US FDA approved manufacturing locations in India as well as North America with DMFs filed across various regulated markets

Financials
Performance Summary - Jubilant Life Sciences

4000 3500 3000 2500 2000 1500 1000 500 0

FY06 FY07 FY08 FY09 FY10 FY11

50% 40% 30% 20% 10% 0% -10% -20%

Operating Income (LHS) OPBDIT Margin (RHS)

OI Growth (RHS) PAT Margin (RHS)

Proprietary products (pyridines and picolines) continue to post strong cash flows supporting other businesses Decline in FY11 due to divestment of Agri & Performance Polymers business and slowdown in growth of Contract manufacturing and drug discovery business Moderately high leverage with debt to equity ratio of 1.3x as on March 2011
Source: Annual Reports, ICRA estimates.

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Key Players Piramal Healthcare

Business Overview
Presence in CRAMS business with assets in India and abroad. Capacity scale up in the past with Aveica (UK) acquisition and Pfizers Morepeth facility (UK) Divested Domestic formulations business to Abbott for total consideration of US$3.8 billion; intend to scale up Contract Manufacturing business through organic and in-organic route Focused CRAMS player with presence across the value chain from drug discovery research service to development and custom manufacturing Recently acquired Ahmedabad based discovery services business which offers synthetic chemistry, medicinal chemistry and computational chemistry; acquisition to complement CRAMS business

Financials
Pirmal Healthcare: CRAMS Revenue and Growth
1080 1060 1040 1020 1000 980 960 940 920 900 880 860 FY 2008 FY 2009 FY 2010 FY 2011 30.0% 25.0% 20.0% 15.0% 10.0% 5.0% 0.0% -5.0% -10.0% -15.0%

CRAMS Revenue (LHS)

Revenue Growth (RHS)

CRAMS revenue affected in financial year 2010 owing to de-stocking by Pharma companies amidst concerns of economic slowdown Recovery during FY11 (+8.6%) with positive growth during H2 FY11; momentum likely to continue going forward as global demand recovers Strong balance sheet with huge cash reserves resulting from sale of domestic formulations business to Abbott
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Source: Annual Reports, ICRA estimates ICRA Limited

INR crore

Key Players Biocon Limited

Business Overview
An integrated biotechnology company with presence across the value chain - R&D, manufacturing and building strengths in marketing CRAMs presence through its subsidiaries (Syngene International Limited, Clinigene International Limited) offering contract research and clinical trials services besides Biocon offering contract manufacturing services for select innovator products (deal with Optimer) Research Services business focus on on discovery research in the areas of Molecular Biology, Custom Synthesis and Chemistry FTEs in pre-clinical phase besides offering clinical trial services; Research Services has partnerships with large global pharmaceutical companies with the company having set up a dedicated facility for Bristol-Myers Squibb

Financials
350 35.00%

300
250 INR crore 200 150 100 50 0 FY2008 FY2009 FY2010 FY2011 Revenues (Rs. crore, LHS) PBIT (Rs. crore, LHS)

30.00%
25.00% 20.00% 15.00% 10.00% 5.00% 0.00%

Revenue Growth (RHS)

PBIT/OI (RHS)

Source: Annual Reports, ICRA estimates for Research business ICRA Limited

Research Services business witnessed strong revenue growth between FY2007 and FY2010; revenue growth in H1FY2011 moderated on account of higher competition faced by the business besides reduced outsourcing budgets of global pharma majors. However, there has been a recovery in revenue growth during H2FY2011 Profit margins impacted due to increasing competitive intensity and commoditisation of services offered Biocon (on consolidated basis) has low debt levels and strong cash balances
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Outlook & Conclusion (1/2)

The global CRAMS market is expected to grow further to approximately US$85 billion by 2012. Increase in outsourcing from developed to developing countries will continue as the innovator companies will lose patent protection for many of their blockbuster drugs over the next few years; thereby forcing them to look for various alternatives such as, cost control and introduction of generics to their portfolio Outsourcing of non-core activities like manufacturing of intermediates and APIs to low cost destinations like India is gaining momentum for pharma MNCs as they focus on their core R&D and brand building business The Indian CRAMS market stood at approximately US$3.8 billion in 2010 and is estimated to reach US$7.6 billion by 2012. With high number of USFDA approved plants, skilled manpower and technical competencies coupled with inherent cost advantage, contract manufacturing is likely to dominate the CRAMS space. The CMO business is expected to be US$7-8 billion opportunity by 2015 as per industry estimates
IndianCRAMS Market
8 7 6 US$ Billion 5 4 3 2 1 0 2009 2010E 2012E

Global CRAMS Market

7.6
90 80 70 US$ Billion 60 50 40 30 20 10 0 2009 2010E 2012E

CAGR 44%

CAGR 13% 58

85 67

3.8
2.5

Source: Industry Reports, ICRA estimates ICRA Limited CRAMS INDIA 20

Outlook & Conclusion (2/2)

Further, Indian Companies have strengthened their presence in the market by acquiring better technologies and developing technical expertise in niche segment (sterile drugs, cytotoxics, lyophilization etc.) that offer higher margins and higher entry barriers. Acquisition of foreign facilities would accelerate growth and foster better relationship with innovator companies, though generating adequate return on such investment needs to be monitored In the long run, companies which provide integrated drug development, research, clinical trial and manufacturing outsourcing services will prove to be one stop shop for all the needs for innovator pharma companies resulting in long term partnerships and better customer franchise Outsourcing of high end services like clinical trials (CTO) and drug discovery (CRO) will require Indian companies to build entrenched relationship with Innovator companies over a period of time; initially with smaller projects and gradually moving onto mission critical and high value add projects The domestic market represents a window of opportunity for CRAMs players as increasingly larger domestic players are outsourcing manufacturing and packaging services to these players in order to focus on marketing and sales and new product development. There ability to offer value added services like drug delivery systems, combination drugs further leverages their value proposition Overall, the outlook for Indian CRAMS appears healthy supported by Contract Manufacturing Outsourcing for APIs and increasing presence in high end Contract research business

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Annexure1: CRAMS - Overview

Area of Contract Research
Drug Discovery Process Pre-Clinical Study Clinical Study

Area of Contract Manufacturing

Custom Synthesis Drug Substance Production
Dosage form development & Production

Disease Study/Target discovery, Target validation, Lead discovery, Lead testing, Lead optimization

In-vivo, In-vitro animal toxicity studies

Phase I, IIA

Scaling up from Lab-scale to kilo level and from kilo to Ton level

Commercial Production of APIs/Intermedia tes

Commercial Production of Formulations in different dosages form

Filing of IND with FDA

Contract Research activities taken on cost plus basis of full time equivalent (FTE) basis

Contract Manufacturing activities for both New Chemical Entities and offpatent drug.

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Annexure2. CMO deals done in past by Indian Companies

Indicative

Indian Company Aurobindo Pharma Strides Arcolab Limited Torrent Pharmaceuticals Indoco Remedies

Outsourcing Partner AstraZeneca, Pfizer Pfizer AstraZeneca Aspen Watson Pharmaceuticals Altana, Zyban Eli Lilly, GSK Solvay, GSK Novartis GSK MNCs

Description Supply generic medicines for developed & emerging markets Supply 67 generic drugs to Pfizer with focus on Oncology Supply 18 products for various markets Range of Ophthalmic Products for 30 emerging markets Develop and manufacture generic drugs with market size of US$ 670 million JV structure for manufacturing on patent drugs Contract manufacturing for APIs and formulations Contract manufacturing for APIs and intermediates Contract manufacturing for intermediates and APIs Contract manufacturing for API Custom chemical synthesis

Indoco Remedies
Cadila Healthcare Shasun Dishman Jubilant Matrix Divi's

Strides Arcolab Limited

Ipca Torrent Pharmaceuticals

GSK
AstraZeneca Novo-Nordisk

Supply of drugs for semi-regulated markets

Contract generics manufacturing of APIs Contract manufacturing of formulations

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Analytical Contacts: Anjan Ghosh +91 22 30470004 Mumbai Subrata Ray +91 22 30470027 Mumbai Gaurav Jain +91 20 25560195 Pune Anupama Arora +91 124 4545303 Gurgaon

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