Transcript Japan ppt - Brian Tempest

Strategic Changes in the Global
Pharma Marketplace
Dr. Brian W Tempest
www.briantempest.com
Mumbai, India
January 2014
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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
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GDP 2028 $b
source: Centre for Economics and Business research 2013
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Strength of Local Generic Companies
source: IMS May 2012
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Indian Pharma penetration of the UK
source: FT January 13 2014
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Big Pharma
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Pharma & Medtech Global Sales
source: Evaluate 23 September 2013
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Big Pharma Top 10 by 2012 Sales
Source: FiercePharma 29 November 2013
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Top 10 Medtech Companies
source: Evaluate Pharma, 23 September 2013
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New Drug Approvals & 5 year USA sales
source: Evaluate
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BTD : Breakthrough Therapy Designation
source: Evaluate, FDA Jan 14 31 products in 2013 6 nibs & 3 mabs J&J 4, GSK 3, Nova 3, smaller cos 12
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Top 20 Regional Growth 2011 & 2012
source: Evaluate 23 June 2013 in local currency
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Divestment & Spin Off Strategies
Source: Various Corporate Announcements
•Novartis - Blood Diagnostics, Animal Health
•Bayer - Bayer Material Sciences likely
•Abbott - Abbvie (pharma assets)
•Pfizer - Nutrition, Zoetis Animal Health
•Merck - separate growth businesses from value
businesses
•GSK - tail products to Aspen, consumer brands
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EM – Emerging Markets, $b
Source: Citi Research August 2013
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Value of EM Bourses - limited availability
source: January 18 2014 Economist
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Generics 35% Premium over last 10years
Source: Societe Generale June 2013
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Global Generics
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Teva
2014-17
CGR 0%-1%
source: RBC Capital Markets 6 January 2014
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Mylan
2014-2017
CGR 5%-7%
source: RBC Capital Markets 6 January 2014
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Actavis
2014-17
CGR 5%-6%
source: RBC Capital Markets 6 January 2014
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Actavis R&D Assets
source: Actavis Promotional Material before Warner Chilcott acquisition
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Actavis Manufacturing Assets
source: Actavis Promotional Material before Warner Chilcott acquisition
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Global footprint of Watson/Actavis
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Teva + Mylan $29b
source: RBC Capital Markets 6 January 2014
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Actavis + Teva $32b
source: RBC Capital Markets 6 January 2014
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Indian Pharma
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India Patents 2005-2012
Source: IPA 2013
•Number of patents issued 1500
•Number of companies 9
•Number of challenges 12
•Number of compulsory licenses 1
•Nexavar Bayer - CL inadequate availability/access at an
unreasonable price
•Glivec Novartis – Section 3d, a polymorph with no
increased efficacy
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Public Health as % of GDP
Source: UNDP 15 October 2012
Cuba
9.7%
USA
9.5%
France 9.3%
UK
8.1%
Brazil
RSA
Russia
China
India
4.2%
3.9%
3.2%
2.7%
1.2%
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Compulsory Licence Rejected
source: ET 31 oct 2013
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Greece, South Africa, Brazil, China - MSF
source: Fierce Pharma 1 April 2013
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India – Anti Corruption Currency
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India Domestic Market Growth
source: Mint 28 Nov 2013
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Indian Pharma in USA
source: Citi Research August 2013
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Indian Pharma in USA
source: Citi Research August 2013
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Indian Pharma in Europe
source: Citi Research August 2013
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India Pharma – EU to EM, % of Sales
source: Citi Research August 2013
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India Pharma in EM
source: Citi Research August 2013
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India Pharma Development Niches
Source: Citi Research August 2013
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India Pharma by Innovation
source: Citi Research August 2013
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India Pharma by USA DMFs
source: Citi Research August 2013
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EU Chemical Sales
source: Chemistry World September 2013
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Private Equity Interest in Indian Pharma
source: VC Circle 19 December 2013
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USA
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USA Generics Pricing
source: Bloomberg 12 december 2013
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Indian Pharma Sales from USA
source: Pharma Times January 12 2014
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Regulatory Inspections
source: Reuters 19 December 2013
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USA FDA Inspections
Source: Indian Express 9 January 2014
India
China
FDA Units
526
960
% inspections outside USA
25%
10%
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MHRA Inspections in India
source: FT January 5 2014
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East Asia Pharma
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China Price Cuts 2012
source: Jefferies
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China Bribery Investigations
source: Jefferies November 2013
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China Competition in Skincare Market
source: FT 18 January 2014
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China - Actavis Withdraws
source: Bloomberg January 15 2014
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Korean Pharma in Biosimilars
source: Citi Research August 2013
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Japan Generic Market
source: Citi Research August 2013
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Indian Pharma in Japan - unimpressive
source: Citi Research August 2013
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Biosimilars
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Biosimilars - Which Way?
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Biosimilars Pipeline
source: Societe Generale
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Big Pharma & Biosimilars
source: Pharma Times 22 December 2013
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Biosimilar Potential for Indian Companies
Source: Citi 25 September 2013
•OECD – sales potential of $1.5b to $2b for US & EU
•OECD - More clarity now on regulatory pathways
•OECD -$100m for R&D development of a MAB, $300m$400m to set up manufacturing capacity of 100,000L with
annual R&D at $100m
•Developing Countries - $200m sales potential, $20m
R&D per year, manufacturing capacity of 1,000L, usage
limited by affordability issues
•Developing countries – Indian companies will enter
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•OECD – likely to use partnerships and alliances eg DRL
India Pharma in Biosimilars
source: Citi Research August 2013
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First Herceptin Trastuzumab Biosimilar
source: ET January 14 2014 Rs 40,000 per 440mg vial, Roche halved price at Rs 55,000
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Biosimilars – The Key Issue
source: GaBi Journal Biologics & Biosimilars 28 December 2013
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Rx OTC Switches
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USA - OTC Switches from POM
source: FDA
102 switches from September 1976 to October 2013
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Europe - OTC Switches from POM
source: IMS 2013
8 out of top 20 EU Brands
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Conclusions
•Top GDP countries have strong local companies
•Big Pharma will keep to its knitting
•Global Generic Cos are expecting single digit growth
•Indian Pharma is expecting growth >20% with a focus
on niches and expansion in the USA
•USA FDA inspections are challenging
•Biosimilar future is unclear, Indian Pharma will enter the
developing countries, interchangeability is the issue
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•Prescription to OTC switches are in fashion
Thank You
[email protected]
www.briantempest.com
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