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Press Conference
Our Journey
December 4, 2013
Yoshihiko Hatanaka
President & CEO
Astellas Pharma Inc.
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Cautionary Statement Regarding Forward-Looking Information
This material includes forward-looking statements based on assumptions and
beliefs in light of the information currently available to management and subject to
significant risks and uncertainties.
Actual financial results may differ materially depending on a number of factors
including adverse economic conditions, currency exchange rate fluctuations,
adverse legislative and regulatory developments, delays in new product launch,
pricing and product initiatives of competitors, the inability of the company to
market existing and new products effectively, interruptions in production,
infringements of the companys intellectual property rights and the adverse
outcome of material litigation.
This material contains information on pharmaceuticals (including compounds under
development), but this information is not intended to make any representations or
advertisements regarding the efficacy or effectiveness of these preparations nor
provide medical advice of any kind.
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Business environment and changes
Challenges for changing tomorrow
Outline of Our Journey
Business environment and changes
Challenges for changing tomorrow
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Businsss environment and changes
Challenges for changing tomorrow
Outline of Our Journey
Business environment and changes
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Growing market
16%
21%
Source:Pricewaterhouse Coopers Pharma 2020 vision
Healthcare expenditure as a percentage of GDP
in OECD countries
CAGR 1.6%
Global Pharma Market : 2011-2016
Copyright 2013 IMS Health
Created by: Astellas based on The Global Use of Medicines: Outlook through 2016
All rights reserved
Pharma market is expected to continue growing steadily
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G
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(
%
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(year)
US OECD Nations excluding the US
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Unmet medical needs
Satisfaction with treatment
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Low
High
Low
HIgh
Sources Pharmaceutical Manufacturers Associations guide 2012-2013 reformed to Astellas
hyperlipidemia
rheumatoid
arthritis
diabetes
<examples>
High satisfaction with treatment
Diseases with high contribution from medications
Diabetes
complication
Alzheimer's
disease
<examples>
Presence of unmet medical needs
Low satisfaction with treatment
Diseases with low contribution from medications
Certain cancers
With current treatment and medication, there are many
diseases that lack sufficient treatment
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Drugs and advancement in biological sciences
Anti-inflammatory drug
Antihypertensive drug
H2 blocker
b blocker
Aspirin
Molecular target drug, Biomedicine
(Antibody, Protein drug etc)
Vaccine
Regenerative medicine
etc
Landing of Science?
Landing of Science?
Technological innovation
supporting new drug discovery
Personal genomic medicine
New generation sequencer
Systembiology
Bioimaging
Bioinfomatics etc
Extraction of active ingredient based on
past experienceDiscovery by luck
Focus on
cell biology
cell technology
Focus on
molecular structure
To step up
Innovation !!
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Pharma market expansion with science evolution
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Changes in the Number of Approved NME
*
New Molecular Entity
Data source: Centre for Innovation in Regulatory Science Ltd
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
EMA 22 14 22 14 24 35 25 26 13 23 21
FDA 23 28 30 20 24 20 24 29 19 32 39
PMDA 23 15 16 19 31 27 26 25 28 31 35
0
5
10
15
20
25
30
35
40
45
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44
16
13
9
5 5
4
3
0
10
20
30
40
50
Japan
USA Switzerland Great
Britain
France
Denmark Germany Others
SourceIMS World Review, Pharmaprojects reprint/replication prohibited)
Created by: Japan Pharmaceutical Manufacturers Association and Office of Pharmaceutical Industry Research
Global sales of top 100 items
excluding one diagnostic product
Country rankings based on new drug development
(2010)
Japan is the 3rd best nation for innovative drug development
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Growing Pharmaceutical Market and Changing Environment
Cost Containment
is being
accelerated
Hurdle to develop
innovative drugs
is getting higher
European
Austerity
Growth of
social welfare
cost
Mandatory
price cuts
Acceleration
of generic usage
policy
Intense
Safety Review by
Regulatory
Authorities
Needs of
differentiation from
existing drugs
High
satisfaction level
of drugs for chronic
diseases
Decreased
drug discovery
seeds
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Outline of Our Journey
Business environment and changes
Challenges for changing tomorrow Challenges for changing tomorrow
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Challenges for changing tomorrow
- Three Strategic Issues for Sustainable Growth -

Maximizing the Value of New Products

Enhancing Ability to Generate Innovative Drugs
Reshaping Reseach Framework
Achieving Operational Excellence
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Maximizing the Value of New Products
Continuous
product rollout
Continuous
product rollout
Lifecycle
management
Lifecycle
management
Strengthening
oncology field
XTANDI expansion or
supplemental
indications
Strengthening
oncology field
XTANDI expansion or
supplemental
indications
Maximizing OAB
franchise
(Vesicare,
Mirabegron
Maximizing OAB
franchise
(Vesicare,
Mirabegron
Strategic
partnership &
marketing alliance
Amgen Astellas BioPharma, MSD
Strategic
partnership &
marketing alliance
Amgen Astellas BioPharma, MSD
Maximizing value
of new products
and overcoming
the upcoming
patent cliffs
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Enhancing Ability to Generate Innovative Drugs
- Business Model of Astellas-
VISION 2015

Innovative
Pharmaceutical
Business Approach
Proprietary Ethical
Pharmaceutical
Business Approach
Global Category Leader (GCL)
Urology
Transplantation
Oncology
Current GCL
Third GCL
Future GCL
Neuroscience
Immunology
& Infectious Diseases
Concentrate Resources
DM Complications
& Kidney Diseases,
etc.
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Enhancing Ability to Generate Innovative Drugs
- Sustainable Growth by improvement of R&D Productivity -
Improvement of R&D Productivity
Enhancing Ability to
Generate Innovative Drugs
Sustainable Growth
Review R&D Resource Allocation in order to Resiliently Respond to the Changing Environment
R&D Operating Resources
Accelerate development of promising preclinical pipeline
Existing areas
External
capabilities and
resources
New TA
*
s and Innovative Modalities
1)
2)
Existing areas
New TAs and Innovative Modalities
In-house Research
In-house Research
External
capabilities and
resources
3)
4)
Ensure sufficient investment in late stage clinical pipeline
*TA: therapeutic area
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External Innovation
(Bio-venture, VC, Academia, CRO, KOL, etc)
Licensing & Alliance
(L&A)
Innovation Management
(A)
Enhancing Ability to Generate Innovative Drugs
Utilize more External Capabilities and Resources
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Internal Research
POC
FIM
Candidate Pivotal Launch NDA Target
Partnering in Early Stage Development
External POC
STAR
(Strategy Team for Therapeutic Area Reinforcement)
Internal Development
Partnering in Late Stage Development
Accelerating Development with External Resources
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,etc.
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Enhancing Ability to Generate Innovative Drugs
Undertake Initiatives related to New Therapeutic Areas and Innovative Modalities
New TAs and Innovative Modalities
Unmet Medical Needs
New TAs
Field of skeletal
muscle activation
Mitochondria
-related
diseases
Collaboration
Collaboration
Innovative Modalities
Regenerative
drugs
Vaccines
External
Resources
Academia, ,
Biotech, etc.
Partnering
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C
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Press release as of June 26
(Japan time)
Press release as of October 7

Disease Frontier
Research Laboratory
Expert Team
Expert Dept.
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Pursue quickest
POC
Utilizing External
Resources(External POC)
Focus investment on highly
prioritized research projects
Enhancing Ability to Generate Innovative Drugs
Accelerate Development of Promising Preclinical Pipeline

L
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Fast Track
New
Standard
Ex. Track
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Enhancing Ability to Generate Innovative Drugs
Ensure Sufficient Investment in Late-Stage Clinical Pipeline
Urology
Immunology
(including
transplantation)
and infectious
disieases
Oncology
Others
solifenacin
neuropathic bladder(pediatric)
ASP0113
Vaccine for infection control during
hematopoetic cell transplantation
isavuconazole
(Aspergillosis, candidemia)
certolizumabpegol
rheumatoid arthritis
(pre-Methotrexate treatment)
enzalutamide
prostate cancer
pre-chemo treatment, non-metastatic)
erlotinib
Non-small cell lung cancer supplemental
pediatric ependymoma
Late phase compounds Filed
ASP7374
prophylaxis of seasonal influenza
degarelix
prostate cancer (3 month drug formula)
solifenacin/mirabegron
urinary frequency, urinary incontinence or urgency
associated with overactive bladder(OAB)
Ipragliflozin
Type 2 diabetes
midazolam
conscious sedation in dentistry and dental surgery
roxadustat
Anemia associated with CKD
AMG 145
Hyperlipidemia
enzalutamide *
prostate cancer
*Filed in Japan,
available in the US and EU
romosozumab
Osteoporosis
Press Conference on May 29
Photograph: Edelman
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Resource
reallocation
Outsourcing
High expertise
Company-wide
perspective
Organization/Team
Operation
Risk
sensitivity
Achieving Operational Excellence
Raise our organization
resilience for future
potential changes
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Our J ourney
for Changing Tomorrow
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