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Views on the Generics Market Dr Brian Tempest Chief Mentor & Executive Vice Chairman of the Board Ranbaxy Laboratories, Delhi, India EGA Conference Istanbul, Turkey 15 th June 2007

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Page 1: Views on the Generics Market Dr Brian Tempest Chief Mentor & Executive Vice Chairman of the Board Ranbaxy Laboratories, Delhi, India EGA Conference Istanbul,

Views on the Generics Market

Dr Brian TempestChief Mentor & Executive Vice Chairman of the Board

Ranbaxy Laboratories, Delhi, India

EGA ConferenceIstanbul, Turkey 15th June 2007

Page 2: Views on the Generics Market Dr Brian Tempest Chief Mentor & Executive Vice Chairman of the Board Ranbaxy Laboratories, Delhi, India EGA Conference Istanbul,

Safe HarborExcept for the historical information contained herein, statements in this presentation and the

subsequent discussions, which include words or phrases such as “will”, “aim”, “will likely result”,

“would”, “believe”, “may”, “expect”, “will continue”, “anticipate”, “estimate”, “intend”, “plan”,

“contemplate”, “seek to”, “future”, “objective”, “goal”, “likely”, “project”, “should”, “potential”, “will pursue”

and similar expressions or variations of such expressions may constitute "forward-looking statements".

These forward-looking statements involve a number of risks, uncertainties and other factors that could

cause actual results to differ materially from those suggested by the forward-looking statements.

These risks and uncertainties include, but are not limited to our ability to successfully implement our

strategy, our growth and expansion plans, obtain regulatory approvals, our provisioning policies,

technological changes, investment and business income, cash flow projections, our exposure to

market risks as well as other risks. Ranbaxy does not undertake any obligation to update forward-

looking statements to reflect events or circumstances after the date thereof.

Page 3: Views on the Generics Market Dr Brian Tempest Chief Mentor & Executive Vice Chairman of the Board Ranbaxy Laboratories, Delhi, India EGA Conference Istanbul,

Key Drivers of Growth

• Significant patent expiries through 2011

• Rationalizing Healthcare costs - key priority for Governments

• Increasing genericisation

0

5

10

15

20

25

30

35

2006 2007 2008 2009 2010 2011

France Spain Italy

Russia South Africa India

$ Bn

Value of Drugs going off patent 2006 - 11

Source : IMS

• Accelerating branded generics

Page 4: Views on the Generics Market Dr Brian Tempest Chief Mentor & Executive Vice Chairman of the Board Ranbaxy Laboratories, Delhi, India EGA Conference Istanbul,

Key Issues

• Increasing competition

• Increasing focus on costs

Page 5: Views on the Generics Market Dr Brian Tempest Chief Mentor & Executive Vice Chairman of the Board Ranbaxy Laboratories, Delhi, India EGA Conference Istanbul,

Geographic Sales Split – Q1 2007

Asia$367, +19%

Americas $440, +18%

Europe$332, +23%*

Africa $85, +24%

* Including CIS, RoW – Rest of the World

Global Sales – Q1 2007 (US$ Mn)

DF 332 +30%

API 23 - 25%

Total 355 + 24%

Sales Q1 2007 – Dosage Forms US$ 332 Mn

29%

31%27%

7%

Page 6: Views on the Generics Market Dr Brian Tempest Chief Mentor & Executive Vice Chairman of the Board Ranbaxy Laboratories, Delhi, India EGA Conference Istanbul,

Increasing Focus on Costs

* Estimate, ^ Bio-Analytical / Bio - Equivalence

2005 2008*

• Increasing sourcing from low cost countries .i.e. India & China

• Improving R&D cost efficiencies

• Optimizing SG&A cost structures

65% 80%35%20%

2006 2005

In-House 71% 28%

Overseas CRO 8% 61%

Indian CRO 21% 11%

% Bio-Studies (BA/BE^) conducted

2006 2005

Sales growth +17%

SGA growth - Nil

Advanced Markets Low Cost Countries

Page 7: Views on the Generics Market Dr Brian Tempest Chief Mentor & Executive Vice Chairman of the Board Ranbaxy Laboratories, Delhi, India EGA Conference Istanbul,

The India Pharma Story – Davos 2006

Source – Financial Times

Page 8: Views on the Generics Market Dr Brian Tempest Chief Mentor & Executive Vice Chairman of the Board Ranbaxy Laboratories, Delhi, India EGA Conference Istanbul,

A race to prosperity

Page 9: Views on the Generics Market Dr Brian Tempest Chief Mentor & Executive Vice Chairman of the Board Ranbaxy Laboratories, Delhi, India EGA Conference Istanbul,

Scientific Manpower Output Number of Higher Education Institutions

05/06 18,123 +59%00/01 11,41290/01 5,93280/01 4,861

Source: Indian University Grants Commission

Number of Students enrolled inHigher Education Institutions

05/06 10,500 +40%00/01 7,50090/01 4,00080/01 3,000Source: Indian University Grants Commission

Number of Institutions courses 05/06 99/00Pharmacy 1478 669 +120%Medicine 229 174 +32%Physiotherapy 205 52 +294%

Source: Pavan Agarwal (2006) based on datafrom professional councils

PhD Degree awarded in Science

03/04 5408 +44%00/01 373490/01 2950(USA 03/04 25,000)

Source: Indian University Grants Committee

Page 10: Views on the Generics Market Dr Brian Tempest Chief Mentor & Executive Vice Chairman of the Board Ranbaxy Laboratories, Delhi, India EGA Conference Istanbul,

The Education Advantage

Engineers/Science graduates p.a. – India 0.7 mn, China 0.5 mn, EU 0.5 mn, USA 0.4 mn, Japan 0.3 mn

Page 11: Views on the Generics Market Dr Brian Tempest Chief Mentor & Executive Vice Chairman of the Board Ranbaxy Laboratories, Delhi, India EGA Conference Istanbul,

India in Global Generics% Share of USA DMF filings

India China

2004 27% 9%

2005 37% 10%

2006 44% 14%

Q4’06 47% 9%

Source: US FDA / J P Morgan Research

FDA Approved

Plants in India

Highest No

of DMF filings

Page 12: Views on the Generics Market Dr Brian Tempest Chief Mentor & Executive Vice Chairman of the Board Ranbaxy Laboratories, Delhi, India EGA Conference Istanbul,

0

40

80

120

160

2002 2003 2004 2005

ANDA Filings in USA by Indian Companies

24

46

64

144

One in every four ANDAs filed by Indian Companies in top US FDA filers (Source: KPMG)

No Chinese generic company has yet filed a US FDA ANDA but expected

in 2008

India in Global Generics

Page 13: Views on the Generics Market Dr Brian Tempest Chief Mentor & Executive Vice Chairman of the Board Ranbaxy Laboratories, Delhi, India EGA Conference Istanbul,

Generic Research & Development• 27 ANDA filings in USA

• 33 Filings in the European Union

Key Country / Region Filings Approvals Filings Approvals

USA 27 10 15 5

European Union 33 32 100 117

BRICS 95 71 14 12

Rest of World 462 474 42 22

Total 617 587 171 156

Dosage Forms API

Excludes India for API approvals, EU filings and approvals include Mutual Recognition Procedure (MRP) and

De-centralized Procedure (DCP) filings and approvals.

2006 Product Filings & Approvals

Page 14: Views on the Generics Market Dr Brian Tempest Chief Mentor & Executive Vice Chairman of the Board Ranbaxy Laboratories, Delhi, India EGA Conference Istanbul,

Enhancing In-house Technologies

Penems

Limuses

Oral High PotencyNon-cytotoxics

Market size worldwide of ~ US$ 1.5 bn

Imipenem + Cilastatin launched in India, China, Africa,

APAC

Key US / EU launches beginning 2009

Global market size in excess of US$ 1.5 bn

Ex - US / EU launches beginning 2008

Well placed for US / EU launches

Worldwide market in excess of US$ 5 bn

Patents expiring from 2008 onwards

Day 1 launches planned for US / EU

Page 15: Views on the Generics Market Dr Brian Tempest Chief Mentor & Executive Vice Chairman of the Board Ranbaxy Laboratories, Delhi, India EGA Conference Istanbul,

Niche Alliances

• Increasing focus on chronic / lifestyle diseases segment

• High entry barriers - technology & resource intensive

Fermentation

based products

Bio-similars &

Oncologics

Peptides

KrebsZenotech Jupiter*

* Subject to due diligence

Page 16: Views on the Generics Market Dr Brian Tempest Chief Mentor & Executive Vice Chairman of the Board Ranbaxy Laboratories, Delhi, India EGA Conference Istanbul,

Recent Acquisitions & Alliances

Terapia (Romania)

Be-Tabs (South Africa)

Allen (Italy)

Ethimed (Belgium)

Mundogen (Spain)

Zenotech (India)

Krebs (India)

Jupiter Biosciences*(Ind.)

Cardinal Drugs (India)

Auto-injector Tech.(USA)

* Subject to due diligence

Page 17: Views on the Generics Market Dr Brian Tempest Chief Mentor & Executive Vice Chairman of the Board Ranbaxy Laboratories, Delhi, India EGA Conference Istanbul,

In Summary• Many reasons for generics industry growth

• However increasing competition

• Continuing focus on cost optimization

• Robust product flow including niches &

alliances

• Growth through organic & inorganic

Page 18: Views on the Generics Market Dr Brian Tempest Chief Mentor & Executive Vice Chairman of the Board Ranbaxy Laboratories, Delhi, India EGA Conference Istanbul,

Thank you

15 June 2007