2016 press conference

March 3, 2016

Eisai Co., Ltd.

Press Conference

Safe Harbor Statement

1

• Forecast or target figures in this material are not official earnings guidance but represent midterm strategies, goals, and visions. Official earnings guidance should be referred to in the disclosure of the annual financial report (Consolidated Financial Statement) in accordance with the rules set by Tokyo Stock Exchange.

• Materials and information provided during this presentation may contain so-called “forward-looking statements.” These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties which could cause actual outcomes and results to differ materially from these statements.

• Risks and uncertainties include general industry and market conditions, and general domestic and international economic conditions such as interest rate and currency exchange fluctuations. Risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, technological advances and patents attained by competitors; challenges inherent in new product development, including completion of clinical trials; claims and concerns about product safety and efficacy; regulatory agency’s examination period, obtaining regulatory approvals; domestic and foreign healthcare reforms; trends toward managed care and healthcare cost containment; and governmental laws and regulations affecting domestic and foreign operations.

• Also, for products that are approved, there are manufacturing and marketing risks and uncertainties, which include, but are not limited to, inability to build production capacity to meet demand, unavailability of raw materials, and failure to gain market acceptance.

• The Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

• This English presentation was translated from the original Japanese version. In the event of any inconsistency between the statements in the two versions, the statements in the Japanese version shall prevail.

• The Company discloses its consolidated financial statements according to the International Financial Reporting Standards(IFRS)

Plan ‘E-WAY 2025’

Converting Knowledge into Business

We Make Medicines, We Make Solutions

through Eisai’s WAY

2

Overview of Plan ‘E-WAY 2025’

• Plan “HAYABUSA” Overall Summary

• Pharmaceutical Industry Environment

• Main Concept of Plan ‘E-WAY 2025’

• Three Strategic Intents and Strategies

– Strategic Intent 1

Aim to support patients’ thought “ I do not want to get sick. I want to know if I get sick, and I want to be cured.”

– Strategy 1 Therapeutic Area Focus

– Strategy 2 “Ricchi” and Innovation

– Strategy 3 ICT Driven Innovation


Aim to support patients’ thought “I want to control my disease in my neighborhood

and spend the rest of my life safe.”

– Strategy 1 Dementia Solutions Business

– Strategy 2 Regional Medicine Focused Business Mix

– Strategy 3 Integrated Product Package


Focus on a business domain where Eisai can find out

“Ricchi” based on needs and fulfill them with Eisai innovation

– Strategy 1 Transformation of Business Portfolio

– Strategy 2 Reform of Manufacturing Site

• Financials

• Towards 2025 3

Plan “HAYABUSA” Overall Summary

1. Qualitative aspect of 5 Aspirations (Rise of Asia

Region, New Market Entry, Establishment of Global

Business Organization, Foundation for Oncology

Business, Improvement of Product Creation

Capability) were attained to some extent.

2. While target in connection with Profit and Loss

Statement was not attained, on the contrary, we

managed to achieve sound Balance Sheet and

shareholder value creation.

3. The factors behind the underachievement of the

revenue target were lack of relevant measures

against business environmental changes due to loss

of exclusivities of main products, and delay in

product creation. 4

Pharmaceutical Industry Environment

Seven Keys

Patient-centricity

Regional Care / Home Care

Prevention, Cure and Care

Outcome

Payer

Access

Digital Technology

Expansion of middle-income class, progress of aging society and

rapid increase of non-communicable diseases

Healthcare focus on quality, efficiency and sustainability

5

Converting Knowledge into Business

We Make Medicines, We Make Solutions through Eisai’s WAY

Main Concept of Plan ‘E-WAY 2025’

Socialization

Spending time together and sharing experiences with patients

True Needs

Understanding real needs of the patients

Motivation for Innovation*1

Fulfilling hhc needs with our innovation

Finding Out “Ricchi”*2

In order to fulfill such needs, we will find “Ricchi”, a place where

no one has achieved success, an untapped space or an

opportunity where Eisai can be a frontrunner.

Establishment of Center Line at “Ricchi”

Major presence in “Ricchi” with our innovation (Center Line)

*1: Innovation refers to “attempts which potentially generate outputs such as science, technologies and business models”

*2: Source: “Strategy in Action 1: The High Road to Business Profitability” Kazuhiro Mishina, Toyo Keizai Inc. 2015 6

Strategic Intent 1

Aim to support patients’ thought

“I do not want to get sick.

I want to know if I get sick,

and I want to be cured.”

-Realize prevention and cure through

Preemptive Medicines, Curative Medicines-

• Toward realizing prevention through preemptive medicine

including early diagnosis and treatment

• Realize treatment for complete remission with curative

medicines and combination regimens

7

Strategy 1

Therapeutic Area Focus

Find out “Ricchi” and

focus on innovation

Strategic Intent 1

8

1. Dementia related diseases

and neurodegenerative diseases

2. Oncology

Therapeutic Area Focus

9

Establishment of

End to End Organization

10

1. The key to pipeline productivity improvement is

making Early Decision in a competitive landscape. This is only possible at an organization where

Discovery, Clinical and Commercial functions are

integrated.

2. Important decisions for prioritizing pipeline, lifecycle

management, and changes in commercial mix should

be made promptly through collaboration between

Discovery, Clinical and Commercial.

3. Scientific Acumen, an important organizational culture,

is developed through integrated business structure

including Discovery.

Design of Therapeutic Area Focused


11

Neurology, Oncology Business Group Structure

Business Group Head

Discovery/

Development Clinical Commercial

Strategy/

Planning


Business Group is responsible for all relevant pipelines and products

from discovery/development to commercial and its Group P/L.

12

Aim to form our business

with Innovation as a pillar at “Ricchi”,

the place where landscape is clear

without crowd as if we would choose

the place to build our house (“Center Line”).

Strategic Intent 1

Strategy 2

“Ricchi” and Innovation

13

Ricchi 2: Novel Neuro-Transmission Pathways AMPA platform, Orexin platform and PDE platform

Ricchi 3: Proteinopathy Dual-track platform (Combining production/aggregation inhibition and

toxic species clearance) Dementia know-how (Integrated know-how on target species selection, stratification/PD markers and sensitive clinical scale)

Human translation technologies through correlation between function (behavior. EEG, fMRI) and pathophysiology (amyloid/tau PET and CSF measurement of toxic species) in genome-editing cell/animal models

Ricchi 4: Neuro-Inflammation and Immuno-Genetics

Immuno-dementia platform, Functional genomics and genome

editing platform and Fractalkine platform Analysis of large genome sequence data (ADNI, Finland consortium,

Genomics plc etc) followed by functional genomics (LoF/GoF in genome editing cells or patient iPS derived neuron) focusing on neuroinflammation to

identify drug targets strongly supported by human biology

Ricchi 5: Synapse Micro-Environment Neurotrophic factor platform

Protein-protein-interaction modulation platform Platform to discover small molecules or functional biologics

(antibody, aptamer, siRNA) which can modulate protein-protein interaction

In synapse micro environment

Neurotrophic factor activators, EphA4 processing enhancers

and other new projects

Ricchi 6: Neuronal Regeneration Genetically engineered

glia implantation platform Technology to handle stem cell and iPS cell aiming at next-generation

therapy including glia cells (astrocyte) implantation

Engineered astrocyte projects

Potential applicability: AD, multiple dementia types, Parkinson‘s disease, amyotrophic lateral

sclerosis(ALS), multiple sclerosis(MS), progressive supranuclear palsy(PSP), corticobasal

degeneration (CBD) and multiple-system atrophy (MSA)

Potential applicability: epilepsy, sleep disorder, movement disorder (e.g. dystonia, tremor), psychiatric disorder (e.g. BPSD), pain (e.g. small fiber neuropathy) Fycompa, lemborexant*1, E2027*1 and other new projects

Potential applicability: AD, multiple dementia types, Parkinson‘s disease, amyotrophic lateral sclerosis (ALS), multiple sclerosis(MS), progressive supranuclear palsy (PSP), corticobasal degeneration (CBD) and multiple-system atrophy (MSA)

Potential applicability: AD, multiple dementia types, Parkinson's disease, amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS) and Down syndrome

Potential applicability: AD, multiple dementia types, Parkinson's disease, amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), hyperactivity disorder(HD) and spinocerebellar degeneration (SCD)

Ricchi 1: Early and Minimally-Invasive Diagnostics Super Resolution Fluorescence Microscopy (partner’s technology) and Blood-based Biomarker

Partnership with Sysmex and other new projects

Neurology “Ricchi” and Innovation

*Platform refers to the drug-discovery technology infrastructure based on innovation, aiming for bearing sequential projects *1: Investigational

Comprehensive analysis method by integrating behavior, electrophysiology, neurochemistry and PET tracer imaging in various animal models Outstanding medicinal chemistry capability for small molecule medicine creation based on blended experienced knowledge, structural biology and informatics

Projects based on novel targets discovered from genetic study and E6011*1

E2609*1, BAN2401*1, tau targeting projects, alpha-synuclein targeting projects and TDP-43 targeting projects

14

KAN Research Institute, Inc. (Kobe, Japan) Platform Technology • Integrated cell biology: Synapse biology, developmental biology and inflammation biology • New perspective in pathophysiology by sharing knowledge/technology among neural,

immune and tumor cell biology • Identification of novel cells and molecules causing disease • Modulation of protein-protein interaction by functional biologics • Handling stem cell and iPS cell aiming at next-generation therapy including glia cells

(astrocyte) implantation

Tsukuba Research Laboratories (Ibaraki, Japan) Platform Technology • Integration of bio-pharmacology and medicinal chemistry with sound knowledge of CNS

drug discovery • Outstanding medicinal chemistry method for small molecule medicine creation platforms

established through in-house discovery projects • Super Resolution Fluorescence Microscopy (partner’s technology), Blood-based Biomarker • Human translation technologies (EEG, CSF measurement) in genome-editing cell/animal • Analysis method by integrating behavior, electrophysiology, neurochemistry and PET tracer

imaging in various animal models

Andover Product Creation Innovation Systems (Andover, U.S.) Platform Technology • Immunogenetic and immunoepigenetic driven target discovery

• Analysis of large genome sequence data followed by functional genomics focusing on

neuroinflammation to identify drug targets strongly supported by human biology

• Human translation technologies using imaging method (fMRI, PET)

• Creation of small compounds with brain penetration based on excellent synthesis

technology cultivated through natural product synthesis

Neuronal regeneration

Neuro-inflammation and

immuno-genetics

Synapse

micro-environment

Proteinopathy


immuno-genetics


immuno-genetics

Proteinopathy

Synapse

micro-environment

Novel neuro-transmission

pathways

Early and minimally-

invasive diagnostics

Neurology Discovery Engine 4 sites

European Knowledge Centre (Hatfield, UK) Platform Technology • Innovative Product Creation for neurodegenerative diseases through organic collaboration

with UCL (University College London) UCL: Target identification through latest genome association analysis including tauopathy and synucleinopathy, establishment and analysis of gene-modified animals, and biomarker research Eisai: Screening technology, medicinal chemistry, obtaining small molecules and biologics, pharmacology, and clinical development

15

E2609*1

Co-development with Biogen

BACE inhibitor (Beta-secretase)

BAN2401*1

Co-development with Biogen

Anti-a-beta protofibrils

antibody

Aducanumab*1

(BIIB037)

Biogen

Anti-a-beta antibody

Lemborexant*1

Co-development with

Purdue Pharma L.P.

Orexin receptor antagonist

E2027*1

PDE9 inhibitor

Preliminary Phase II study’s safety and PK/PD data anticipated, and request for

End of Phase II meeting with FDA planned in March 2016

Planning development scenarios for Phase III studies to shorten timeline

including possibility of combination therapy

9th interim analysis (600 patients) occurred in January 2016

Interim analysis at 650 patients is anticipated in March 2016

Possibility of Early Success*2

Planning development scenarios for Phase III studies

Two Phase III studies (18-month primary endpoint) in patients with early AD ongoing

Eisai has an option to jointly develop and commercialize

Plan to initiate Phase III study in insomnia in Q1 FY2016 in which

approximately 40% subjects will be elderly patients (over 65)

Sleep disorders are prevalent in over half of dementia patients and bidirectional

relationship between sleep and dementia is being implicated*3

Preliminary proof-of-mechanism observed in Phase I study

Planning designs for additional clinical development studies targeting

improvement in cognitive function and BPSD*4 in dementia patients

Launch target:

shortly after

FY2020

Launch target:

before

FY2020

Launch target:

beyond

FY2020

Launch Target of AD/Dementia Pipeline

New Molecular Entities

*1: Investigational *2: Eligible for early stoppage if the active drug arm is determined to be likely to be more effective than the placebo arm

*3: Liguori C et al. JAMA Neurol. 2014 Dec;71(12):1498-505. *4: Behavioral psychological symptoms of dementia 16

Global Brand Fycompa and BELVIQ®

Value maximization projects*1

(Lifecycle management)

Partial onset seizure/ Primary generalized tonic-clonic seizures

Submitted in July 2015 in Japan Launch target

FY2016

Oral suspension

formulation Submitted in June 2015 in U.S. and EU

Launch target

FY2016

Pediatric for

partial-onset seizure Phase II study ongoing in U.S. and EU

Launch target

FY2018

(U.S., EU, Japan)

Monotherapy Under discussion with agencies

in U.S. and EU

Launch target

FY2016 (U.S.)

FY2017 (EU)

Partial onset seizure Accelerate development for launch in China

Launch target

FY2019

Lennox-Gastaut

syndrome Currently planning strategy for expanding

indication in U.S. , EU and Japan

Launch target

FY2020

Once-daily

formulation Submitted in September 2015 in U.S.

Launch target

FY2016

Cardiovascular

outcomes trial

(CVOT)

• Evaluation on MACE*2, conversion to type 2 diabetes

and MACE+*3

• Completed patient enrollment (approx. 12,000) in

November, 2015

Topline result

anticipated in FY2018

Obesity Phase I study ongoing in Japan Launch target:

FY2020 (EU)

Beyond FY2020 (Japan)

*1: All projects are investigational *2: MACE: Major Adverse Cardiovascular Event including myocardial infarction, stroke and cardiovascular (CV) death

*3: MACE+: including myocardial infarction, stroke, CV death, and hospitalization due to unstable angina, heart failure, or any coronary revascularization 17

Oncology “Ricchi” and Innovation

18

Platform technology • lenvatinib/Kinase inhibitor platform

(including combination with PD-1 inhibitors):

Tsukuba original diverse small molecule libraries targeting kinases.

Biomarker/profiling data sets from lenvatinib clinical samples to

identify new targets on abnormal tumor vessels and tumor

microenvironment associated with drug resistant mechanisms.

Projects

• Halaven+anti-PD-1 antibody pembrolizumab*1,

Halaven+PEGPH20*1*2, Halichondrin derivatives


Projects

• E7046*1 (Cancer immunotherapy agent based on inhibitory effect of

EP4*3) and other new projects

Ricchi 1: Cancer Microenvironment

Ricchi 1-1: Mesenchymal Cells and Tumor Stroma

(Cell Differentiation and Cancer Stemness)

Ricchi 1-2: Myeloid Cells

(Immunosuppressive Myeloid Lineage)

Ricchi 1-3: Endothelial Cells

(Abnormal Tumor Vessels)

Ricchi 2: Driver Gene Mutation

and Aberrant Splicing

Platform technology • Cancer genomics platform:

State-of-the-art bioinformatics and genetic tools to identify and

validate new cancer driver gene and splicing targets

• Splicing platform:

Compound libraries of splicing modulators, and a unique set of

screening systems to identify novel, splice variant-specific modulators,

including high throughput in vitro Splicing Assay (IVS), high throughput

RT-qPCR Screening and Minigene Assay.

Projects

• SF3B1 modulator*1, FGFR4 inhibitor*1 and other new projects

Endothelial

cells Myeloid

cells Platform technology

• Prostaglandin/Toll-like receptor platform

(cancer immunity platform targeting myeloid cells):

• Chemistry strength on development of unique compound libraries

of EP2, EP4*3 and Toll-like receptor antagonists

• Cell-based assay systems

• Assay system to evaluate cancer immunity through myeloid cells

Platform technology • Eribulin platform:

Natural product synthesis chemistry to synthesize highly complex

compounds and the halichondrin-based compound library. Cancer biology &

translational research tools, including bio-imaging and PDX models

• Morphotek’s antibody platform:

Morphotek’s antibody (anti-TEM1 antibody and others)

Original site-specific conjugation technology

• Cancer stemness platform:

Functional cell based phenotypic assay systems and animal models to

evaluate cell differentiation, epigenetic control and tumor metabolism

Cancer cells

Mesenchymal

stromal cells Lymphoid

cells

*Platform refers to the drug-discovery technology infrastructure based on innovation, aiming for bearing sequential projects *1: Investigational *2: Investigational PEGylated recombinant human hyaluronidase under development by Halozyme Therapeutics, Inc. *3: Prostaglandin E2 receptors abbreviated as EP. There are 4 subtypes; EP1,EP2,EP3 and EP4

Projects

• Lenvima + anti-PD-1 antibody pembrolizumab*1


Tsukuba Research Laboratory (Tsukuba, Japan) Lenvatinib/Kinase Inhibitor Platform • Diverse small molecule library targeting kinases • Biomarker/profiling data sets for Lenvatinib clinical samples allowing us to further identify new

targets on abnormal tumor vessels and tumor microenvironment associated with drug resistant mechanisms.

Cancer Stemness Platform • Complex functional cell based phenotypic screening systems and animal models to evaluate

cancer plasticity phenotypes, i.e., cell differentiation, epigenetic control and tumor metabolism.

• Single cell-based analysis technology to address tumor heterogeneity.

Eribulin Platform • Natural product chemistry to synthesize highly complex compounds and the Halichondrin-based

compound library.

• Immunosuppressive

myeloid lineage

• Cell differentiation

• Cancer stemness

• Abnormal tumor

vessels

Oncology Discovery Engine 4 sites

• Immunosuppressive

myeloid lineage

Andover Product Creation Innovation Systems (Andover, U.S.)

Prostaglandin/Toll-like receptor Platform

(Cancer immunity Platform targeting Myeloid cells) • Unique compound libraries of EP2, EP4 and Toll-like receptor antagonists combined with cell-

free and cell-based assay systems to dissect compound profiles as well as potential biomarkers.

• Assay system to evaluate cancer immunity through myeloid cells.

Morphotek (Exton, U.S.) Morphotek’s antibody Platform • Antibody collecting technology for various antigens including anti-folate receptor alpha antibody,

anti-mesothelin antibody, anti-TEM1 antibody.

• Morphotek original site specific conjugation technologies (ReSpect technology and others).

• Cell differentiation

• Cancer stemness

• Driver gene

mutation

• Aberrant splicing

H3 Biomedicine (Cambridge, U.S.) Cancer Genomics Platform • State-of-the-art bioinformatics to identify new cancer drivers, as well as potential biomarkers. • Genetic tools to validate new targets in genetically defined experimental systems.

Splicing Platform • Screening systems for splicing modulators including High Throughput in vitro Splicing Assay

(IVS), High Throughput RT-qPCR Screening and Minigene Assay. • Compound library of splicing modulators.

19

Identification and validation of driver gene mutations based on cancer patients’ genomic data

Discovery of drugs targeting modulation of aberrant splicing

in cancer cells

Discovery of next-generation compounds targeting drug

resistant mutations which inhibits cure of cancer

Strategy for Drug Discovery based on Human

Cancer Genome for Personalized Medicine

Aim to launch H3 Biomedicine products within 10 years of establishment

Drug discovery and

diagnosis for drug resistant

mutation in cancer cells

Diverse scientific talents in Boston, innovative collaboration with outside

partners, and swift and robust decisions based on human biology data Developed 2 compounds for clinical trials

within 5 years of establishment

Advancing innovative drug discovery based on

human cancer genome since its inception in 2010

Capabilities of cancer genome

analysis and validation which

have been established at H3B

Deep understanding of

splicing biology at H3B

Initiation of first clinical trials: targeted in 1H FY2016

Inhibitor of FGFR4* Driver to occurrence and

progression of Hepatocellular carcinoma

and others.

Modulator of

splicing factor SF3B1*

Myelodysplastic syndrome and others.

3 initiatives at H3 Biomedicine (H3B)

Focus on cancer genome and aberrant splicing enables

developments with fewer patients and in shorter time

H3 Biomedicine

Aim to launch the new product in FY2020 Eisai’s first personalized

medicine

* Investigational 20

World-class Small Molecular Science

Aiming for Cure of Cancers

World-Class excellence in natural product

synthetic organic chemistry nurtured through

the creation of Halaven to pursue further

pharmaceutical potential of Halichondrins

LENVIMA Halaven

Investigational E7046

Halichondrins

Morphotek technologies

Unique MOAs beyond simple anti-angiogenesis (actions on immuno-suppressive cancer associated macrophage, etc.), synergistic when combined with immune checkpoint inhibitors

Sequential creation of innovative pipeline

projects from the unique kinase library

established on LENVIMA discovery at Tsukuba

Research Lab

Unique compounds targeting Myeloid cell

lineage (Toll-like receptor antagonists and

prostaglandin receptor antagonists),

asset inherited in Andover Research Institute

Addition of novel mechanism of action (tumor

vascular remodeling and decreased tumor

migration and invasiveness) on the US

package insert of Halaven

Novel cancer immunotherapy agent

differentiated from existing immune

checkpoint inhibitors targeting lymphoid cell

lineage

Linker chemistry enabling effective linkage

between various antibodies and molecules

(small molecules, toxins, or radio-labeled

compounds and others)

Antibody producing technologies for versatile

antigens (anti-folate receptor alpha antibody,

anti-mesothelin antibody, or anti-TEM1

antibody and others)

21

MORAb-003 Anti-folate receptor

alpha-antibody

E7046 EP4 receptor inhibitor

E7090 FGFR inhibitor

E7777 IL-2 diphtheria toxin

fusion protein

MORAb-009 Anti-mesothelin antibody

SF3B1 modulator

FGFR4 inhibitor

HBI-8000*2

Histone deacetylase inhibitor

(HDAC inhibitor)

E7438*3

EZH2 inhibitor

Launch target EU: FY2019

Japan, U.S.: Beyond FY2020

Launch target

Global: Beyond FY2020

Launch target

Global: FY2020

Launch target

Global: FY2020

Launch target Japan, U.S.:FY2020 (CTCL)

Japan: FY2020 (PTCL)

Launch target


Launch target

Global: FY2020

Launch target

Japan, Asia: Beyond FY2020

Launch target

Japan: Beyond FY2020

Platinum-sensitive ovarian cancer

Phase II study ongoing

Solid tumor

Phase I study ongoing

Solid tumor


Cutaneous T-cell lymphoma (CTCL)

Peripheral T-cell lymphoma (PTCL)


Mesothelioma


Myelodysplastic syndrome

Hepatocellular carcinoma

Peripheral T-cell lymphoma (PTCL)

T-cell leukemia-lymphoma


Phase II registration-supporting study ongoing in adult patients with non-Hodgkin lymphoma

Phase II registration-supporting study ongoing in adult patients with certain genetically defined solid tumors

Phase I dose escalation study ongoing in pediatric patients with certain genetically defined solid tumors

Novel Morphotek’s antibody Launch target


Solid tumor

Preclinical study ongoing

*1: All projects are investigational *2: Under development in collaboration with HUYA Bioscience International, LLC. Eisai retains development and market rights in Japan, South Korea, Thailand, Malaysia, Indonesia, Philippines, Vietnam and Singapore *3: Identified as tazemetostat, which is under development in collaboration between Epizyme Inc. and Eisai. Eisai retains responsibility for development and commercialization within Japan, as well as having the right of

first negotiation for licensing rights in Asia

Launch Target of Oncology Pipeline

New Molecular Entities*1

22

*1: Investigational *2: Prescription Drug User Fee Act *3: Anti-PD-1 antibody, pembrolizumab *4: Approved for advanced liposarcoma

*5: Investigational PEGylated recombinant human hyaluronidase under development by Halozyme Therapeutics, Inc.

Global brand LENVIMA and Halaven

Value maximization projects (Lifecycle management)

Renal cell carcinoma

2nd line*1

Submitted in November 2015 in U.S.

PDUFA*2 action date: May 16th, 2016

Submitted in January 2016 in EU

Phase I study ongoing in Japan

Launch target

U.S., EU: FY2016

Japan: FY2019

Hepatocellular

carcinoma 1st line*1

Biliary tract cancer

2nd line*1

Endometrial cancer*1

Combination therapy with

immune checkpoint inhibitor*1,3

Completed enrollment of Phase III study in July 2015

Submission planned in FY2016

Initiated Phase II study in August 2015 in Japan

Phase IIb study under preparation

Lung cancer, melanoma, head and neck cancer, bladder cancer, renal cancer, and endometrial cancer

Phase Ib/II study ongoing

Launch target

Global: FY2017

Launch target


Launch target

U.S., EU: Beyond FY2020

Soft tissue sarcoma Submitted based on the result of Phase III study (309 study) in

Japan, U.S. and EU*1

Launched in January 2016*4 in U.S. and in February 2016 in Japan

Launch target

EU: 1H FY2016

Combination therapy

with PEGPH20*1,5

Combination therapy

with immune checkpoint

inhibitor*1,3

Investigating the potential to HER2-negative breast cancer through

combination therapy with PEGPH20

Phase Ib/II study under preparation

Launch target


Investigating the potential to triple-negative breast cancer through combination therapy with

anti-PD-1 antibody, pembrolizumab

Initiated Phase II study in December 2015

23

Strategy 3

ICT Driven Innovation

Strategic Intent 1

24

ICT Driven Innovation

Launch of the Data Creation Center

as the Global Hub

1. Build state-of-the-art ICT Infrastructure

Build state-of-the-art cloud-based ICT infrastructure which enables one-stop

access and smart search functions through integrated internal data and

company-wide uniform management of access to Big Data such as genome

data, compound data, electric medical record, care data and medical bill data.

2. Innovation based on analysis of Big Data

Analyze Big Data including real world data utilizing advanced analytical

technology with artificial intelligence. Such analysis enables us to identify

potential new drug targets, biomarkers. Furthermore, possibly provide

customized solution to patients’ individual needs and create evidence for

outcome evaluation and others.

25

Solution

hhc knowledge

Medical Life style

Biomarker Customer behavior

Research Paper

One-stop access and Smart search

New Drugs New Compound New Business New Target New Solution

Novel Patient Value Creation through

Integration and Smartification of Big Data

New Idea

Integrated product package strategy

• Integration of access point

to establish accessible and

usable database

• Unlinked-database groups

• Individual analysis results

• Scattered data

• Product Creation with high potential of success with lower expenses

• Provide solutions to fulfill patients’ individual needs

• Create new evidence and strategy for integrated product package strategy through Outcome analysis

• Data science

• Artificial intelligence

• Big Data integration

• Original database

accessible with smart

search functions

• Dataset analyzed based on

patients’ point of view

Data Creation Center

26

Strategic Intent 2

• Establish patient-friendly community network

through partnership with local government in home

care oriented environment

• Provide integrated product package aiming for

maximum Outcome through collaboration with

home care market group and integrated community

care group

Aim to support patients’ thought

“I want to control my disease in my

neighborhood and spend

the rest of my life safe.”

27

Strategy 1

Dementia Solutions Business

Strategic Intent 2

28

Early diagnosis

Community networking Treatment/Care options

Provide social resource map in

connection with dementia including

specialized medical institutions and

regional support facilities on e-65.net

Respond to customers’ inquiries on

dementia through hhc Hotline

(since Aricept launched in 1999,

approx. 130,000 inquiries have been

received)

Eisai original diagnostic scale/treatment

effect measure such as ADCOMS*2

VSRAD*3, diagnosis support software for

early AD

Collaboration with key opinion leaders in the

field of dementia through academic meeting,

education for physicians how to diagnose

dementia and others

Long term activities to support patients

with dementia and community networking

with 527 communities in Japan

Collaboration with local government

(Agreement with 53 communities as of

February 2016)

Development of multidisciplinary model

cloud system

Provide information on dementia through

e-65.net*1

Enhance awareness through TV ads

Operate forums for citizens in

collaboration with local government

Collaboration with dementia support

organizations

Provide information on dementia through

e-65.net

Aricept’s various formulations to fulfill

patients’ needs; OD tablet, jelly, dry

syrup, film coated tablet, granule and film

Obtained world’s first indication for

dementia with Lewy bodies in Japan

Development of adherence support

device

Clinical data of dementia

21 reports on Aricept double blind

trials (6804 cases)

Aricept post marketing clinical data of

approx. 30,000 cases

Abundant experience in development

of disease modifier

Eisai’s dominant advantages

Eisai’s Accumulated Dementia Assets

Disease awareness

Provide information

and consultation

Pioneer in Dementia Field

*1 e-65.net: Website for disease awareness and provision of information for patients with dementia and their families run by Eisai (only available in Japanese)

*2 Alzheimer’s Disease Composite Score *3 Voxel-Based Specific Regional Analysis System for Alzheimer's Disease

29

Strategy for “Eisai Dementia Solutions”

Awareness

e-65.net

保険薬局介護事業者

合同会社協議会

Accumulated

dementia asset since

Aricept launch

Community

networking

Options for treatment

and nursing care

Consultation

for dementia (hhc hotline)

Early diagnosis

(ADCOMS and

VSRAD)

Collaboration partners

for dementia care

Local healthcare project with local government and organizations

Promote local healthcare project in collaboration with partners of dementia.

In cooperation with medical institutions, healthcare supporting pharmacies, home nursing care

facilities, we will contribute to local government and local residents by providing Solutions.

Dementia solutions

Eisai will provide

Multidisciplinary

cooperation

system Adherence

support device

Care

support

tool

Algorism of dementia projection

through Big Data analysis

Early

diagnosis

tool

Healthcare supporting

pharmacies

Medical institutions

Care operators and others

Academia

Local government

Residents

30

Strategy 2

Regional Medicine Focused Business Mix

We aim to demonstrate Outcomes more than

treatment efficacy, toward Prevention, Cure and Care.

Evidence derived by Medical will be the foundation

for the Outcome information. Access will advance

when prominent evidence is demonstrated.

Strategic Intent 2

31

<Corporation of Regional Medical Collaboration>

Acute care hospital

Convalescent care

hospital

Acute care hospital

Clinic

Chronic care hospital

<Home care market>

Local comprehensive care support center

Primary care

doctor

Nursing home

Home-visit

doctors

Home-visit nursing station

Healthcare supporting pharmacy

Home-visit

doctors

Multidisciplinary coordination team Primary care doctor

Primary care pharmacist Home-visit nurses

Care manager

Various medical institutions in the same community will be under the uniform management

Optimization and cooperation of community medicine will be accelerated

Joint-purchase of drugs, devices and others by HQ of Corporation will take place; the formation of new “Ricchi”

Healthcare supporting pharmacy will recommend doctor consultations such as dementia screening in addition to adherence support if necessary, and act as major player in home care market

Multidisciplinary coordination team

will provide home care including medical support

Adherence support Healthcare support Doctor consultation

recommendation Nursing home

Joint-purchase of drugs devices, and others

New Regional Healthcare Support Establishment in Japan

Home care market and Corporation of Regional Medical Collaboration*

Regional

doctors’

association

Local

government

Corporation of Regional Medical Collaboration

(corporate headquarters function)

* Establishment planned by Ministry of Health, Labour and Welfare in FY2017 32

Establish Project Mix with

Medical, Outcome and Access as the Core

Outcome Access

• Evaluate and analyze

the value of Eisai

products and integrated

product package,

including economical

efficiency based on the

information of Outcome

• Proposition of value to

customers based on the

Outcome from Eisai

products

Medical

• Information on treatment

outcome of

pharmacotherapy and

integrated product

package more than

treatment efficacy; Prevention of tumble

Prevention of fracture

Shortening of length of

stay at nursing home

Improvement of labor

productivity

Prolongation of healthy

life expectancy

Prolongation of working

years

Improvement in the level

of care requirement

assessment

Improvement of QoL

at home care and others

• Explain the data with

certain qualification

(e.g. academic papers)

including preclinical and

clinical to specialists

• Outcome creation followed

by data generation

through real world data

from access of Big Data

and contract based clinical

studies

33

Renewal of Japan Business

Japan Business

EA

Pharma

Elmed

Eisai

(generics)

Oncology

hhc Unit Integrated

8 HQ Access &

Outcome

HQ

Dementia

Solution

HQ

Medical

HQ Consumer

hhc

Business

34

Strategy 3

Integrated Product Package

Provide integrated product package

aiming for maximization of Outcomes

Strategic Intent 2

35

Overview of Integrated Product Package

1. “Ricchi” will be formed with the emergence of

unconventional stakeholders in growing home care

market and Corporation of Regional Medical

Collaboration (establishment planned in FY2017 by

MHLW) , a major player for regional healthcare in

the future.

2. We will provide integrated product package consist

of Eisai, EA Pharma and Elmed Eisai products to

“Ricchi”. And will aim to increase access by creating

information of Outcomes.

36

Strategy for Creating Integrated Product Package of

Eisai, EA Pharma and Elmed Eisai products

Eisai Elmed Eisai EA Pharma

Branded drugs and long-listed drugs Branded drugs and long-listed drugs Generics

Evaluate the Outcomes including treatment efficacy and

economical efficiency from integrated product package

* The products designated by MHLW as Premium to promote the development of new drugs and eliminate off-label use

Seek to develop integrated product package aiming for the cure

of high incidence diseases in Home care market,

including dementia, insomnia, osteoporosis, constipation and others.

Packaging 3 companies’ (Eisai, EA Pharma and Elmed Eisai) products

in 3 categories (branded drugs*, long-listed drugs and generics) to meet customer’s needs

37

Focus on a business domain

where Eisai can find out

“Ricchi” based on

needs and fulfill them

with Eisai innovation

Strategic Intent 3

38

Strategy 1

Transformation of Business Portfolio

We will find “Ricchi” and focus on business

that Eisai continuously develops innovation

and depart from the business that Eisai could

not develop further innovation

Strategic Intent 3

39

Milestone of

Business Portfolio Transformation

2012 Pharmaceutical machinery business

Eisai Machinery Co., Ltd.

2013 Soil amelioration business

Eisai Seikaken Co., Ltd.

2015 Diagnostic business

EIDIA Co., Ltd.

2016 Food and chemical business

Eisai Food & Chemical Co., Ltd.

(Transferred to Bosch Group)

(Transferred to Lawson, Inc.)

(Transferred to Sekisui Chemical Co., Ltd.)

(Transferred to Mitsubishi-Kagaku Foods Corporation)

40

EA Pharma Co., Ltd.

As the gastrointestinal disease area gains a more important

position in home care market and community medicine,

we will continuously operate pharmaceutical full-value chain of Discovery to Commercial

Lower digestive tract area, liver/bile/pancreas areas, constipation and nutrition area

• Product creation based on proprietary AminoScience

technologies

• New product pipeline

• Established opinion leader networks

• Eisai group’s integrated product package

“Ricchi”:

Innovation:

Objectives:

41

Neurology Oncology

Bone metabolism,

Heart disease,

Otorhinology, etc.

GI

Immunology

Metabolic

Liver

Generic Business OTC Business

Shared service

Plan “HAYABUSA”

Plan ‘E-WAY 2025’

Innovative Solution Business

Logistics

Neurology Business Group

Oncology Business Group

Integrated Generic Business

Consumer hhc Business

hhc Solutions Group

EA Pharma Co., Ltd.

Transformation of Business Portfolio

42

Strategy 2

Reform of Manufacturing Site

Strategic Intent 3

43

Transformation of Manufacturing Sites

2013 Tainan Factory in Taiwan

(Transferred to Bora Corporation)

2014 Misato Plant in Japan

(Transferred to Bushu Pharmaceuticals Ltd.)

2015 North Carolina Plant in U.S.

(Transferred to Biogen Inc.)

2016 Sannova in Japan

(Plan to transfer to Alfresa Holdings Corporation)

44

* “Demand Innovation Plus” is the symbol of aspiration aiming for maximizing value on products and solutions for patients.

Reform of Manufacturing Sites

45

Hatfield (U.K.)

Bogor (Indonesia)

Kawashima (Japan)

Baltimore (U.S.)

Exton Laboratory(U.S.)

(Pilot plant) Utilize manufacturing technology for antibody fostered by production of clinical trial material of Morphotek’s antibody in order to prepare for commercial in-house production of antibody in the future

Supply "unique wafer product"

for intracranial use globally by

utilizing proprietary technology

• Establish dementia café and others to discover hhc true needs at Kawashima, a base for production of treatments for dementia. Annually tens of thousands of people visit “Museum of Pharmaceutical Science”, which is located in the same site of Kawashima.

• Aim to establish a seamless manufacture system regardless of volume that does not requires scale-up from discovery to commercialization, by utilizing innovative continuous manufacturing different from existing batch method.

• Aim to obtain Halal certificate and supply for countries with Halal needs by utilizing locational advantage since approx. 90% of population in Indonesia has Halal products need

• Seek to export Halal certified products to Malaysia and other countries with high needs

Kashima (Japan)

• Leverage world class synthesis technology for commercial production, applied to Eribulin, to commercial production of APIs for small molecule drugs

• Launch original site-specific conjugation technology to aiming for in-house production of antibodies

Volume Base

Pursued optimization of site operational rate and logistics based on volume( ~ 2012)

Innovation Base

Establish “Ricchi” by utilizing strength of each site and conduct demand innovation activities worldwide

Suzhou/Benxi (China)

Vizag (India) Supply fine Eisai products for various income class to fulfill growing needs on quality through collaboration between Suzhou’s factory’s high quality manufacturing technology and newly acquired Benxi factory’s lineup of generics

Leverage powerful and extensive infrastructure for pharmaceutical production established mainly for generics; • Develop and supply APIs and products

for generics • Produce and supply free of charge, 2.2

billion DEC tablets for treatment of Lymphatic Filariasis (- 2020)

• Develop and supply combination tablets

• Stable worldwide supply of established drugs

Transformation

• Leverage experience on

multi-lingual and small volume packaging in EU market for global expansion.

• Employ serial number system, the world’s best

level measurement to comply with

anti-counterfeit regulations.

Establishment of

* Unit

Seek to develop/manufacture with cutting-edge technologies including IC chip products and wearable devices through collaboration between each site aiming for fulfilling hhc True Needs

The group to add “+(plus)”

passion and value into

Demand Innovation

45

Financials

46

Target toward FY2020

in Plan ‘E-WAY 2025’

Revenue

Operating profit

Profit for the year

FY2015

Forecast

FY2020

Target FY2015

Forecast

FY2020

Target

51.0B yen 37.0B yen

More than

double

More than

double

556.5B yen

800B yen or more

FY2015

Forecast

FY2020

Target

47

0

2,000

4,000

6,000

8,000

2015年度見通し 2020年度目標

Aim for Double-digit Growth of CAGR*1

in Americas, China, Asia and EMEA

Revenue growth simulation*2 by region

(Billion yen)

800

600

400

200

0 FY2015

Forecast

FY2020

Target

Consolidated

EMEA

Asia

China

Americas

Japan*3

Approx.

14%

Approx.

10%

Approx.

12%

Approx.

15%

Approx.

3%

Approx.

8%

CAGR

*1: Compound annual growth rate *2: Figures are approximate *3: Including revenue of Consumer Healthcare Business 48

0

1,000

2,000

3,000

4,000


Growth Simulation of Global Brands

including Planned Value Expansion Projects

Revenue growth simulation* of global brands

(Billion yen)

400

200

100

0

300

FY2015

Forecast FY2020

Target

CAGR

Approx.

57%

Approx.

65%

Approx.

55%

Approx.

14%

* Figures are approximate 49

Progress of Therapeutic Area Focus

0

2,000

4,000

6,000

8,000


46%

60%

Revenue growth simulation*1 by therapeutic area

(Billion yen)

800

600

400

200

0

Oncology

Area

Neurology

Area

Others*2

CAGR

Approx.

16%

Approx.

12%

FY2015

Forecast

FY2020

Target

*1: Figures are approximate *2: Including products unrelated to Oncology/Neurology areas 50

Towards 2025

51

Aducanumab*1,2

Anti-A-beta antibody

Early AD

Lemborexant*1

Orexin receptor antagonist

Insomnia and others

Before FY2020

Next-generation AMPA

receptor antagonist*1

Epilepsy and others

Beyond FY2020

Overview of Flagship Pipeline for Robust Growth

-Towards FY2025-

Endothelial cells Myeloid

cells

Cancer cells

Mesenchymal

stromal cells

E7046*1

EP4 receptor inhibitor Solid tumor FY2020

Novel antibody drug*1

Development with

Morphotek technology

SF3B1 Modulator*1

Myelodysplastic syndrome Beyond FY2020

LENVIMA

VEGF/FGFR/RET kinase inhibitor Renal cell carcinoma*1, hepatocellular carcinoma*1 and others Globally launched in 2015 for thyroid cancer*3

Oncology

E2609*1

BACE inhibitor

Early AD

Shortly after FY2020

E6011*1

Anti-fractalkine antibody Rheumatoid arthritis and others Beyond FY2020

*1: Investigational *2: Currently under development by Biogen. Eisai has an option to jointly develop and commercialize. *3: Indicated in the U.S. for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer; indicated in Japan for the treatment of unresectable thyroid cancer; indicated in Europe for the treatment of adult patients with progressive, locally advanced or metastatic differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma (DTC) refractory to radioactive iodine (RAI)

E2027*1

PDE9 inhibitor Dementia Beyond FY2020

Mechanism of action Target indication Launch target

BAN2401*1

Anti-A-beta protofibrils antibody

Early AD

Shortly after FY2020

Proteinopathy Neuro-inflammation and immuno-genetics

Synapse micro-

environment

Early and minimally-invasive diagnostics

Neuronal

regeneration

Novel neuro-transmission

pathways

Neurology

FGFR4 Inhibitor*1

Hepatocellular carcinoma FY2020

Lymphoid cells

52

KPIs Target for FY2020

ROE 10% or more

Equity Spread*1 2% or more

DOE*2 8% level (Maintain 150 yen dividend/ share)

Equity to total asset ratio*3 50% or more

Net DER*4 0.3 or less

Debt Capacity 230B yen level

Aim for Sustainable Corporate Value Creation

* Dividend per share subject to resolution of Board of Directors

Aim for 15% level ROE in FY2025

*1: Equity spread = ROE - Cost of equity (CoE), assume cost of shareholders’ equity of 8%

*2: Dividend on Equity *3: “Equity to total asset” displayed is “Ratio of equity attributable to owners of the parent”

*4: Net DER: Net Debt Equity Ratio = ［Interest bearing debt – (cash and deposits + marketable securities)］ / shareholders’ equity

Financial Integrity to ensure strategic investments and stable dividend

53

Towards 2025

“MEDICO SOCIETAL INNOVATOR, Eisai”

Prevention Care Cure

Medical, Outcome, Access

“MEDICO SOCIETAL INNOVATOR”

Preemptive

Medicines

Curative

Medicines Solutions

Fulfill Needs

Regional medicine that provides peace of mind and safety

Fulfill Needs

54

2016 press conference

Documents