Hale & Tempest Mergers, Acquisitions & Alliances in Emerging Markets Dr. Brian W Tempest Generics & Biosimilars, CpHI Conference Istanbul, Turkey 19 September 2012

Hale & Tempest Dr 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 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 Brian has worked in the Pharmaceutical Industry for the last 41 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, a Non Executive Director of Fortis Healthcare the leading Asian Healthcare Company, a Non Executive Director of SRL the largest Indian Diagnostic Company and a Non Executive Director of Glenmark Pharmaceuticals. He is a member of the SCRIP Global awards panel and 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 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, 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 Co Ltd

Hale & Tempest Debt Impacting Global Healthcare

Hale & Tempest But Healthcare will expand faster in Asia

Hale & Tempest Pressures on Big Pharma

Hale & Tempest Pharma Business Model source: Pharmatimes World News April 2012

Hale & Tempest Is the Big Pharma Business Model Sustainable?

Hale & Tempest One of the largest R&D failures  “Nobody endured these lessons harder than Pfizer. The company built the world’s largest pharmaceutical research centre in Connecticut, USA, a 160 acre site with more than 5,000 employees at its peak and 2.7m sq ft of research space. But the only major drug to come out of the sprawling facility in the past 20 years was the smoking cessation treatment Chantix” Source; Pharmatimes February 2012

Hale & Tempest But Pharma R&D still needs Funding source: FT

Hale & Tempest So R&D Spend to 2018 is still growing source: Evaluate pharma 2012

Hale & Tempest Regulatory Challenges source: Pharmatimes World News Feb 2012

Hale & Tempest Big Pharma Corporate Fines Source: Daily Mail 3 July 2012

Hale & Tempest Big Pharma Corporate Fines source: FT August

Hale & Tempest Merck – No 1 Layoffs in 2011 source FiercePharma

Hale & Tempest Will Big Pharma Change?

Hale & Tempest Big Pharma Changing Strategies  Share repurchase - Pfizer, Sanofi Aventis  Shedding businesses – Pfizer $1.9b nutrition, $3.6b animal health, £2.4b Capsugel  Eye Care - Novartis & Alcon  Consumer Healthcare – Sanofi Aventis, GSK  Generics – Pfizer, Sanofi Aventis, AZ  Pharmemerging – GSK, Abbott, Daichi Sankyo  OTC – P&G with Teva entering India

Hale & Tempest Sanofi, GSK, Merck & Novartis cut Prices source: FT

Hale & Tempest Following the Asian Growth source: Bangkok Post 26 July 2012

Hale & Tempest >60% of GSK is a “non white pill” source: GSK Investor Presentation q4 2010, (vaccines, consumer, respiratory, derma)

Hale & Tempest Price Competition from Big Pharma at Jan 2012  ATORVASTATIN - Ranbaxy in India 5 Rs per tablet - Pfizer in NZ 1 Rs per tablet  CEPHALEXIN - Ranbaxy in India - GSK in India half price

Hale & Tempest Competition & Risk for Generic Companies

Hale & Tempest Generics - Rising Risk & Competition

Hale & Tempest Contagious Price Erosion Across Markets source: Deutche Bank 22 may 2012

Hale & Tempest Patent Expiries to 2018 source: EvaluatePharma 2012

Hale & Tempest Global Generic Market Future Growth

Hale & Tempest Losing Control in the EU source: Teva June 2012

Hale & Tempest Stada focus on Russia Source: Stada

Hale & Tempest India Compulsory Licence source: ET 13 March 2012

Hale & Tempest New Measures allow Compulsory licences source: Chemistry World August 2012

Hale & Tempest Pending USA FDA ANDAs source: Deutsche Bank Jan 2012, 67%

Hale & Tempest ANDAs from Hisun, China in 2014/15

Hale & Tempest Indian Company Investment in Discovery source: Glenmark Annual Report 2012

Hale & Tempest Biosimilars

Hale & Tempest Deutsche Bank HK July 2010

Hale & Tempest Biotech Drugs where India has no DMF Source: JGM Volume 6 p333 sep 2009

Hale & Tempest Biosimilars from Indian Pharma Source: Deutsche Bank Jan 2012

Hale & Tempest How much is a Biosimilar worth? Source: Datamonitor

Hale & Tempest Sandoz Business Model -18 Year Payback source: Pharmacloud June 2012

Hale & Tempest Stada Licence In 2 Biosimilars source: Stada June 2012

Hale & Tempest Alliances – the New Faces

Hale & Tempest Rising Biosimilar Competition  Argentina Government is buying 14 cell lines from a Vancouver Company for local manufacture  In Thailand there are currently 19 EPOs  Celltrion, SK capacity is several 20,000L facilities with enough for the world’s supply  WHO is evaluating 2,000L capacity plants for Palivizumab in LA and Africa

Hale & Tempest Recent Biosimilar Deals  Cipla & Biomab, China $165m 12 products  Richter & Stada – mABs, 2 products  Celltrion, Korea -Hospira, Egis, Hikma, BB, etc  Biocon & Mylan, USA, mABs  Teva & Lonza, EU – limited range  Biocon Idec & Samsung, Japan  Watson & Amgen, USA  Fuji Film & Kyowa Hakko Kirin  DRL & Merck-Serono, Germany - mABs  Actavis & Bioton, Poland - Insulin  Pfizer & Hisun, China

Hale & Tempest Will the Tinibs takeover from the mABs? (Tinibs - Tyrosine Kinase Inhibitors -small molecules)  Axitinib, Pfizer, cancer  Cediranib, AZ, cancer  Pazopanib, GSK, cancer  Regorafenib, Bayer, cancer  Semaxanib, Sugen, cancer  Sorafenib, Bayer(Nexavar),cancer  Sunitinib, Pfizer, cancer  Toceranib, Pfizer, cancer  Vandetanib, AZ, cancer  Tofactinib, Pfizer, RA

Hale & Tempest Biosimilars from China/India Source: New York Times 20 Sep 2011

Hale & Tempest A New World Order in Pharma is Coming

Hale & Tempest Thank You