actavis as a generic company - eibd conference as a generic company in indonesia dr. leiman sutanto...
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Actavis as a Generic Company
in Indonesia
Dr. Leiman SutantoOperations Director
PT Actavis Indonesia
30 November 2010
Why generics?
“If there’s a blue pill and a red pill, and the blue pill is half the price of the red pill and works just as well, why not pay half the price for the thing that’s going to make you well?” - Barack Obama -
A generic:US$34.34
* Source: the Generic Handbook 3rd edition published 2009
Average prescription retail prices in the US in 2007*
No sustainable healthcare reformwithout a robust generics industry
A brand name:US$119.51
Why not more Generics
Why is big pharmalooking into generics?
Growth in key markets steadily declining
New product pipelines disappointing
No sign that drug discovery is going to be
easier
Opportunities in emerging markets:
Brazil, Russia, India, China, Mexico, Turkey
and S-Korea
Recognising the economic trends that led to
increasing collaboration between big pharma
and generics
Consolidation & collaboration
Many originators moving into genericsin some forms:
• GSK• Aspen, Dr Reddy's
• Pfizer• Aurobindo, Claris
• Sanofi-Aventis • Winthrop, Zentiva, Medley, Kendrick
• Novartis – Sandoz• Several looking towards India
• Daiichi Sankyo- Ranbaxy
Generic players must master the game
Building capabilities on many fronts at the same time as maintaining their area of excellence
Complexity increasesProducts & Market reach
Healthcare reforms
Increasing competition Price erosion
Regulatory reforms
• Build scale
• Integrate and capture synergies
• Achieve levels of operational and supply excellence, beyond ever seen
• Investment in pipeline to fuel future growth:
• R&D • Regulatory & IP
• Dynamic approach to S&M• Innovation• Customised market approach
Current challenges Building excellence
Trend in Generic World
Two main factors of success for future winners:
1. Technical capabilities
2. Selling skills
Future winners execute their strategies
The industry will changeProduct complexity will drive
industry transformation
Global Top 20 Brands 2009
The industry will changeProduct complexity will drive
industry transformation
Global Top 20 Brands 2016
Biologics
37% 46% 13% 12%25% 23% 40% 72% 25% 8% 6% 12% 60% 25% 24% 38% 106% 19%
39% 36%
% CAGR 2005 - 2009
Technical Capabilities:R&D expenses benchmark
Company reports 09, Zentiva 08
In m
io €
*) estimated 100 mio Momenta R&D not shown here**) 2008 published figures
Who has the resources to execute?
Selling skillsfrom “essential similar” to “essential different”
Cytotoxics
Hormones
ß lactams
Devices
Formulation
Biologics
API
Steriles
Liquids
r&d complexity
man
ufac
turi
ng b
arri
erlo
whi
gh
low high
Actavis Manufacturing Sites
Cost competitive, quality, global manufacturing base
Capacity of 24 billion tablets & capsules
• 16 pharmaceutical manufacturing plants in 13 countries• Plus one manufacturing plant in Norway for plasters
and two API manufacturing sites in Chennai, India and Hangzhou, China
Compliance• All fulfill local regulatory
requirements • 14 plants EU and/or FDA compliant• One of two API facilities with FDA
compliance
Actavis in
INDONESIA
From acquisitions & expansion …..to having achieved a strong platform for growthto growth through pipeline, optimisation andefficiency
Actavis is evolving
A remarkablegrowth story
• Over 10,000 employees• Present in over 40 countries• Over EUR 1.7 billion in sales 2009• 850 products on the market• 333 projects in pipeline• 24 billion tablets/capsules capacity
• 146 employees• Present in 1 country• EUR 57 million in sales
Actavis in 1999 Actavis today
Development Status – end 1H 2009
Early Development
Full Development
Biostudy / Stability Registration
80 91 25 137
Total pipeline: 333 projects
EU US ROW TotalDevelopment projects 87 84 25 196Molecules 71 73 21 165Ongoing registrations 51 81 5 137
Source: IMS, Total Market, Ethical Only Q2 2010
Top 25 Manufacturers Ethical in MATQ2 2010
RANK MAT MANUF DESC'05 '06 '07 '08 '09 JUN '10 VALUE (MIDR) MARKET SHARE GROWTH (vs. MAT 06/2009)
ETHICAL MARKET 20,722,418 100.00 13.74
3 3 1 1 1 1 KALBE FARMA 1,596,592 7.70 13.791 1 2 2 2 2 SANBE 1,235,058 5.96 1.302 2 3 3 3 3 DEXA MEDICA 1,021,671 4.93 11.364 4 4 4 4 4 PFIZER 810,134 3.91 6.66
12 9 8 7 6 5 FAHRENHEIT 757,380 3.65 27.169 10 9 5 5 6 INTERBAT 722,861 3.49 8.846 6 6 6 7 7 SANOFI-AVENTIS 683,564 3.30 12.477 7 7 9 8 8 KIMIA FARMA 607,541 2.93 21.44
22 17 12 10 10 9 DANKOS 570,360 2.75 16.7314 20 15 14 12 10 HEXPHARM JAYA 537,611 2.59 34.8613 12 11 11 11 11 BAYER INDONESIA 515,694 2.49 15.325 5 5 8 9 12 INDOFARMA 490,245 2.37 0.75
17 15 13 15 15 13 NOVARTIS 474,565 2.29 34.8716 13 14 13 13 14 GLAXOSMITHKLINE PH 430,691 2.08 13.8910 11 10 12 14 15 OTSUKA 389,158 1.88 1.9518 14 16 16 16 16 ASTRAZENECA 354,027 1.71 11.3525 21 17 17 17 17 OTTO 343,816 1.66 8.7989 87 77 70 59 18 MERCK SHARP&DOHME 324,798 1.57 3.3311 22 20 18 19 19 FERRON PAR PHARM 322,501 1.56 8.1123 18 18 19 18 20 COMBIPHAR 320,328 1.55 5.3315 23 23 22 21 21 PHAROS INDONESIA 318,562 1.54 19.3920 19 21 21 20 22 ROCHE 312,080 1.51 14.5424 25 25 23 22 23 MERCK KGAA 295,367 1.43 14.8328 24 26 24 23 24 B.INGELHEIM 292,074 1.41 18.7926 28 27 25 24 25 SANDOZ 270,999 1.31 12.5038 34 35 33 30 26 ACTAVIS 269,596 1.30 38.95
MAT JUNE '10RANK AT MAT DEC
Actavis is well-positioned to capitalize on OGB growth while leveraging existing
strengths
0.0%
0.2%
0.4%
0.6%
0.8%
1.0%
1.2%
2003
2004
2005
2006
2007
2008
2009
2010
Actavis Strong in Key Anti-Infectives TA*
11% 11%
18%
0%
20%
40%
60%
80%
100%
Mkt MATQ1 2009
Mkt MATQ1 2010
ACTAVISMAT Q12010
OTHERS (<4%)
M MUSCULO
V VARIOUS
D DERM
C CARDIO
R RESPI
N NERVOUS
J ANTI INFECT
A ALIMENTARY
Actavis Demonstrating Consistent MS
IMS MIDAS Data *Sales by ATC1
Mar
ket
Shar
e
% S
ales
Indonesia’s Healthcare Expenditure isset to grow over the coming Decades
Historically, ASEAN had lower health expenditure levels; Now with the growth of GDP, spending has began to increase
Source: IMF World Economic Outlook Databases, ASEAN statistics 2008
Market Summary
• The fragmented Indonesian healthcare system consists of a mixture of public and private healthcare providers, with most private facilities located in Jakarta and other urban areas
• High share of out-of-pocket spending for most healthcare provision and pharmaceutical purchases
• Significant market growth potential in line with increasing income and fast growing population
• Well established local industry
• Introduction of GMP standards
Industry Opportunities & Challenges
• Fast, double-digit growing generic market
• Demand for generic drugs to increase with the continuing expansion of the healthcare sector and rising cost awareness
• Government plans to increase the coverage of health insurance to 100% of the population will include more than 100 mio additional people to the health insurance
• Escalating API cost and taxation of imports
• Poor efficacy of counterfeit drugs leading to a distrust of pharmaceuticals
Market Dynamics
Regulation & Regional Business Environment
Business Environment Overview: Indonesia
USD mio
2009 2013 CAGR
Total Market 3,022 4,233 9%
Patented 1.128 1,463 6%
Generics 0.685 1,140 14%
OTC 1,125 1,693 8%Business Monitor Report Indonesia Q1/2010
• ASEAN had lower health expenditure level, however with the growth of GDP, spending has begun to increase
• AFTA & ACFTA in 2011
• One single ASEAN market in 2015
• SJSN will boost the growth of non-branded market to the additional coverage of >100 mio people
• 10/10 regulation makes local production of most products mandatory, resulting in high number of transfers
Healthcare Industriesneed
Government’s support
INDONESIA
Drug RegistrationSome Issues
• Limitation on new drug application (copy product) – only 1 product per week per Company, and only ca. 15 Cos/week
• First copy product, Company has to provide “self assessment on patent status” – no G2G link (BPOM – Patent office)
• No product list at BPOM for products require BA/BE study – needs consultation every time
• Long registration lead time – more than 2 years for NDA
• Also lead time for exported products – more than 1 year, require stability testing for CZ IV although exporting to CZ II
• BPOM needs additional HR to cover pending registration approval
Export / ImportSome Issues
• Pharmaceutical business has not got sufficient support from the attache of trade of Indonesian embassy in the targetted countries – focus only on big businesses/commodities
• They do not promote Indonesian Pharmaceutical Products –Companies have to promote their own products
• Improve the knowledge / networking of our businessman in the targeted countries – each country has their own regulations
Export / ImportOther Issues
• Simplification of permit application in order to shorten lead time in the government offices, such as BPOM, Ministry of Health, Custom Office, etc.
• Comply to the international quality standard
• Domestic market oriented and less export oriented in the globalization environment
• Professionalism of local players when dealing with foreign customers
• International business knowledge should be taught intensively starting at the university
Thank you!