Hale & TempestStrategic Changes in the Global Pharmaceutical MarketDr. Brian W Tempest www.briantempest.comAugust 2011Hale & TempestDr Brian Tempest advises Companies, Banks, High Net Worth Individuals and Investment Funds on their Strategy in the Emerging World based on his wide experience in China, Japan, South East Asia and India where he has lived for the last decade. Brian has worked for Ranbaxy Laboratories since 1995 holding the position of Managing Director and Chief Executive Officer until 2005. He was then Chief Mentor and Non Executive Director until 2008 when he retired. He is one of the few westerners to have led a Sensex Nifty 50 Indian blue Chip MNC and as a result has a valuable insight into India. Brian has also worked for Glaxo as Regional Director Far East and Regional Director Middle East & Africa from 1985 to 1992. Brian has worked in the Pharmaceutical Industry for the last 40 years and has managed Healthcare businesses in North America, South America, Europe, Africa, Middle East, Australasia, China, Japan and India. He has also led many sessions at Investor Meetings held around the world. He is now Independent Chairman of Religare Capital Markets PLC and Non Executive Director of SRL the largest Indian Diagnostic Company. Brian is an international advisor to MAPE, India and the United Nations (UNCTAD) in addition to being a member of the SCRIP Global awards panel he is on the Editorial Board of the Journal of Generic Medicines. Brian speaks at global conferences and more information on these presentations can be found on his website www.briantempest.com. Brian has a PhD in Polymer Chemistry from Lancaster University in 1971 and in 2009 he became Chairman of the Advisory Board for the Lancaster University Management School which ranks 4th in the UK He is a Fellow of the Royal Society of Medicine and a Fellow of the Royal Society of Chemistry and is a Chartered Chemist. He is now Chairman and Senior Partner of Hale & Tempest Hale & TempestGeneric Medicines are part of the Solution for Ageing PopulationsHale & TempestChina/India with 37% population, 14% of wealth and most of the GDP growthHale & TempestStructural Change -Big PharmaHale & TempestIn 2010, FDA approved Only 21 New Drug Source: Fiercebiotech 22 Jan 2011Hale & TempestUSA Dept. of J Fines on Big Pharma Source: Chemistry World Jan 2011Hale & TempestUSA Batch Recalls Source: Deutchen Bank 29 March 2011Hale & TempestApprovals & Reimbursements Source: Pharmatimes UK July-August 2010Hale & TempestBig Pharma Losing to Local Players Source GSK PresentationHale & TempestEmerging World Share of Pharma Source EIU, OECD, WHO, IMS, Roland BergerHale & TempestTop 8 Cos in Emerging Markets 2008 Hale & TempestIncreasing Pace of Emerging Markets AcquisitionsEmerging Market Investor DaysMarch 16, 2010December 10, 2009July 2, 2009Large Pharma Entering Generics(Egypt, Pakistan, Near East )(MENA, LatAm, Asia-Pac)(Algeria)With the slow-down of Western markets, Pharma are rapidly repositioning to focus on emerging markets for growthHale & TempestSales Force Job Cuts in Press since 2009Hale & TempestStructural ChangeGeneric CompaniesHale & TempestAsia vs. the Western Generic Companies Source: Factset, ReligareHale & TempestPricing Pressures Source: WatsonHale & TempestEuropean Generic Prices Source RanbaxyHale & TempestEuropean Generic Prices Source RanbaxyHale & TempestUSA - ANDA Growing Approval Times Source FDA Chief M Hamburg, GpHA Conference February 2010 2005 16.3 months average2009 26.7 months averageAround 2000 ANDAs awaiting approvalFDA explained as a result of staff shortagesRegulatory filing fees neededHale & TempestSeason of Warning Letters / Import Alerts Source: Deutche Bank July 2011Hale & TempestUSA - Litigation Success Rates Source RBC Capital Markets January 15 2010Patent Challenges on rise - 65 FTFs in 2009Success rate at 48% - or 76% including deals3 courts hold 69% with 36% success e.g. NJ4 courts never ruled against generics e.g. NYAt risk launches on the rise 6 in 2009Teva has 12 of the 28 at risk launches 2002/9Settlements on the rise 54 in 2009Teva accounts for a third of all settlementsAuthorized generics on the rise 25 in 2009Watson represents a fifth of all AGsHale & TempestGeneric Profit Margin Profile in descending order source: Deutsche Bank July 2010Hale & TempestTop 25 Global Generic Companies Source: Generics Bulletin 10 June 2011Hale & TempestNext 24 Global Generic Companies Source: Generics Bulletin 10 June 2011Hale & TempestPatent Expiries Source: SandozHale & TempestIn 2016, Among Top 10, 8 will be Biologic/RespSource: Sandoz EGA Conference 2011Hale & TempestStructural ChangesIndian Pharma CompaniesHale & TempestWHO Pre Qualified ProductsH