hale & tempest the sustainability of the generics industry – rethinking the future dr. brian w...
TRANSCRIPT
Hale & Tempest
The Sustainability of the Generics Industry – rethinking the future
Dr. Brian W Tempest
www.briantempest.com
World Generics Congress, London, UK 29 February 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 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 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 PLC , 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 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, 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
Healthcare Pressures Forever - 2050
Hale & Tempest
Healthcare will explode further in Asia
Hale & Tempest
Consolidation in Generics 2003 - 2010
Hale & Tempest
Structural Changes -
Big Pharma
Hale & Tempest
Fewer New Molecules Approved
Hale & Tempest
Only 21 2010 FDA New Drug Approvals Source: Fiercebiotech 22 Jan 2011
Hale & Tempest
Approvals & Reimbursements Source: Pharmatimes UK August 2011
Hale & Tempest
US 2010 False Claims Fines Chemistry World Jan 2011
2011 False Claims Fines - Pfizer $2.3b, Lilly $1.4b, J&J $1.b
Hale & Tempest
Top Five US Industries for layoffs in 09/10Source Challenger, Gray & Christmas
Hale & Tempest
Merck – No 1 Layoffs in 2011 source FiercePharma
Hale & Tempest
Big Pharma Strategies
Share repurchase - AZ, 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 OTC – P&G with Teva DPI Inhaler – Pfizer & Mylan Generics – Pfizer, Sanofi Aventis, AZ Pharmemerging – GSK, Abbott, Daichi Sankyo
Hale & Tempest
M&A Deals in Pharmemerging MarketsSource: Company Filings, Mape Securities
Hale & Tempest
Structural Changes -
Generic Companies
Hale & Tempest
Pricing PressuresSource: Watson
Hale & Tempest
Mylan won’t follow “irrational behavior” Source : Generics Bulletin 5 August 2011
Hale & Tempest
India Pharma Stock has consistently outperformed Global Peers Bloomberg
Hale & Tempest
Emerging Market Equities in last 12mSource: 30 Jan 2012 Business Standard
Hale & Tempest
Rising CompetitionSource: JM Financials 24 August 2011, Deutche Bank 8 July 2011
With generic Lotrel higher strengths there was an unexpected excessive number of generics approved after the exclusive period ended
Increased competitive activity with para 4 filings. Multiple players for small opportunities.
Small new Indian players in para 4 - Macleods for Lipitor, Hetero for Nexium
Hale & Tempest
Top 25 Global Generic CompaniesSource: Generics Bulletin 10 June 2011
Hale & Tempest
Next 24 Global Generic CompaniesSource: Generics Bulletin 10 June 2011
Hale & Tempest
USA Generics Filings Source: Deutsche bank July 2010
Hale & Tempest
Pending ANDAs source: Deutsche Bank Jan 2012
Hale & Tempest
US Litigation Risks are Substantial
Patent Challenges on rise - 65 FTFs in 2009 Generic success rate at 48% (76% with deals) 3 courts hold 69%, with 36% success e.g. NJ 4 courts never ruled against generics e.g. NY At Risk launches on the rise - 6 in 2009 Teva has 12 of the 28 At Risk launches 2002/9
Source RBC Capital Markets January 15 2010
Recent At Risk launch damages include – Apotex $0.3b, Sun $0.9b, Teva $1b+ Famvir
Teva rethinking At Risk strategy
Hale & Tempest
China Pharma Industry Capex PlansSource: Stravencom
Hale & Tempest
India Pharma Industry Capex PlansSource: MAPE
Hale & Tempest
FDA DMFs from China 3Q 2011
Hale & Tempest
Indian Companies Changing HandsSource Mint Research December 13 2011
Hale & Tempest
Frost & Sullivan forecast the Global Generic Market at $231b in 2017 FiercePharma
Hale & Tempest
70% of Top products will be Biologic-2016Source: Sandoz EGA Conference 2011
Hale & Tempest
Biosimilar Patent Expiries $17b in 2015 Source: Sandoz
Hale & Tempest
Biosimilar Patent Expires $64b in 2015Source: IMS
Hale & Tempest
Number of mABs entering the clinic annually rose to 54 in 2008 Source: Tufts
Hale & Tempest
How much is a Biosimilar worth?Source: Datamonitor
Hale & Tempest
Recent Biosimilar Deals
Cipla & Biomab, China $165m 12 products Richter & Stada – mABs Celltrion, Korea & Hospira, Egis, Hikma, BB Biocon & Mylan, USA Teva & Lonza, EU Biocon Idec & Samsung, Japan Watson & Amgen, USA Fuji Film & Kyowa Hakko Kirin Baxter & Momenta, USA Actavis & Bioton,Poland Pfizer & Hisun, China
Hale & Tempest
A New World Order in Generics is Coming
