hale & tempest mergers, acquisitions & alliances in emerging markets dr. brian w tempest ...

Hale & Tempest

Mergers, Acquisitions & Alliances in Emerging Markets

Dr. Brian W Tempest

www.briantempest.com

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 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, 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

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 FinesSource: Daily Mail 3 July 2012

Hale & Tempest

Big Pharma Corporate Fines source: FT August 7 2012

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 Youbrian.tempest@clara.co.uk

www.briantempest.com