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Press Conference

Our JourneyDecember 4, 2013Yoshihiko HatanakaPresident & 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 company’s 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 HealthCreated by: Astellas based on The Global Use of Medicines: Outlook through 2016All rights reserved

Pharma market is expected to continue growing steadily

Ration o

f healthcare

expenditure

to G

DP (

%)

(year)

US OECD Nations excluding the US

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Unmet medical needs

Satisfaction with treatment

Contrib

ution o

f dru

g d

uring tre

atm

ent

Low

High

Low HIgh

Sources： Pharmaceutical Manufacturers Association’s guide 2012-2013 reformed to Astellas

hyperlipidemia

rheumatoid arthritis

diabetes

<examples>

High satisfaction with treatmentDiseases with high contribution from medications

Diabetes complication

Alzheimer'sdisease

<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)

VaccineRegenerative medicine

etc

Landing of Science?

Landing of Science?

Technological innovation

supporting new drug discovery

・Personal genomic medicine

・New generation sequencer

・Systembiology

・Bioimaging

・Bioinfomatics etcExtraction of active ingredient based on past experience／Discovery by luck

Focus oncell biology

cell technology

Focus onmolecular 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 2012EMA 22 14 22 14 24 35 25 26 13 23 21FDA 23 28 30 20 24 20 24 29 19 32 39PMDA 23 15 16 19 31 27 26 25 28 31 35

0

5

10

15

20

25

30

35

40

45

Num

ber o

f NME ap

provals

9

44

1613

9

5 5 4 3

0

10

20

30

40

50

JapanUSA Switzerland Great Britain

France Denmark Germany Others

Source：IMS 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 -

１

２

３

Maximizing the Value of New Products

Enhancing Ability to Generate Innovative Drugs （Reshaping Reseaｒch Framework）

Achieving Operational Excellence

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１．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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２．Enhancing Ability to Generate Innovative Drugs - ＧＣＬ：Business Model of Astellas-

VISION 2015で掲げた指針・目標を継続する

新薬ビジネス

Innovative Pharmaceutical Business Approach

Proprietary Ethical

Pharmaceutical

Business Approach

Global Category Leader (GCL)

Urology

TransplantationOncology

Current GCL Third GCL Future GCL

Neuroscience

Immunology & Infectious Diseases

ー Concentrate Resources ー

DM Complications& Kidney Diseases,etc.

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２．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 ResearchExternal

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

(AＩＭ)

２．Enhancing Ability to Generate Innovative Drugs１） Utilize more External Capabilities and Resources

Multi-

track R

&D

syst

em

s

Internal Research

POCFIMCandidate Pivotal LaunchNDATarget

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）

Strate

gy

pla

nnin

g

Seed

scre

enin

g

Scie

ntific

eva

luation

Alli

ance

negotiations

,etc.

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２．Enhancing Ability to Generate Innovative Drugs２） 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

Regenerativedrugs

Vaccines

External Resources（Academia, , Biotech, etc.

Partnering

＋

Fiv

e P

rioritize

d T

hera

peutic C

ate

gories

※Press release as of June 26(Japan time)

※Press release as of October 7

ＡＩＭDisease Frontier

Research Laboratory

Expert TeamExpert Dept.

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Pursue quickest POC

Utilizing External Resources(External POC)

Focus investment on highly prioritized research projects

２．Enhancing Ability to Generate Innovative Drugs３） Accelerate Development of Promising Preclinical Pipeline

Ｐ

Ｏ

Ｃ

Launch

Fast Track

New

Standard

Ex. Track

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２．Enhancing Ability to Generate Innovative Drugs４） Ensure Sufficient Investment in Late-Stage Clinical Pipeline

Urology

Immunology (including

transplantation)and infectious

disieases

Oncology

Others

solifenacinneuropathic bladder(pediatric)

ASP0113Vaccine for infection control during

hematopoetic cell transplantation

isavuconazole

(Aspergillosis, candidemia)

certolizumab pegolrheumatoid arthritis

(pre-Methotrexate treatment)

enzalutamideprostate cancer

（pre-chemo treatment, non-metastatic)

erlotinibNon-small cell lung cancer （supplemental）

pediatric ependymoma

Late phase compounds Filed

ASP7374prophylaxis of seasonal influenza

degarelixprostate cancer (3 month drug formula)

solifenacin/mirabegronurinary frequency, urinary incontinence or urgency

associated with overactive bladder(OAB)

IpragliflozinType 2 diabetes

midazolamconscious sedation in dentistry and dental surgery

roxadustatAnemia associated with CKD

AMG 145 Hyperlipidemia

enzalutamide *prostate cancer

*Filed in Japan, available in the US and EU

romosozumabOsteoporosis

※Press Conference on May 29（Photograph: Edelman）

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Resource reallocation

Outsourcing

High expertise

Company-wide perspective

Organization/Team Operation

Risk sensitivity

３．Achieving Operational Excellence

Raise our organization resilience for future potential changes

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Our Journeyfor Changing Tomorrow

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