Information Meeting
March 6, 2020

Eisai Co., LtdSafe Harbor Statement
 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 anduncertainties that 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 notlimited to, technological advances and patents attained by competitors; challenges inherent in new productdevelopment, including completion of clinical trials; claims and concerns about product safety and efficacy;
regulatory agency examination periods and 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.
 Furthermore, 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 cannot guarantee the actual outcomes and results for any forward-looking statements.
 The Company disclaims any intention or obligation to update or revise any forward-looking statements whether as aresult of new information, future events or otherwise.
 The English-language presentation was translated from the original Japanese-language version. In the event of any
inconsistency between the statements in the two versions, the statements in the Japanese-language version shallprevail.

 The Company discloses its consolidated financial statements according to the International Financial ReportingStandards (IFRS).

Plan ‘EWAY 2025’
Converting Knowledge into Business
We Make Medicines, We Make Solutions
through Eisai’s WAY• Plan ‘EWAY 2025’ is the mid-term businessplan from FY2016 to FY2025• We have positioned the period of FY2016 toFY2019 as “EWAY CURRENT” and reviewed• We have positioned the period of FY2020 toFY2025 as “EWAY FUTURE” and analyzed
1

EWAY
CURRENT(FY2016～FY2019)2

EWAY 2025 Strategic Intents“Therapeutic Areas of Focus”,“Transformation of Business Portfolio”
and “ ‘Ricchi’ and Innovation”

Creation of Neurology andOncology Business Groups

Progress to Partnership Model3

Progress of Partnership Model
With Biogen(Strategic partnership originally established in March 2014
and expanded in October 2017)

Progress of co-development:- Aducanumab*1: under preparation for filing- BAN2401*1,2
Study 201: completed
Study 201-OLE*3 : ongoing
Clarity AD*4
: ongoing
AHEAD 3-45*5: under preparation- Elenbecestat*1: discontinued
Multiple sclerosis business:- Co-promotion in Japan- Commercialization by Eisai in Asia excluding China
Close cooperation:
CEO level, Development, Regulatory, Medical, Manufacturing,
Commercial
4*1: Investigational. Co-development with Biogen. *2: Investigational antibody for Alzheimer’s disease produced as the result of a strategic research alliance between
Eisai and BioArctic. *3: Open-label extension *4: Phase III study for BAN2401 *5: AD prevention study in collaboration with Alzheimer’s Clinical Trials Consortium(ACTC) and is comprised of A3 substudy and A45 substudy

Progress of Partnership Model

With Merck (1) (Strategic partnership since March 2018)*1- All planned milestones are expected to be achieved based on
steady progress of collaboration regarding LENVIMAFY2017

One-time payment for certain option rights

$300M
$25M
$325M
$125M
$75M
$25M
$50M
$200M

Sales-based milestone payment (CY $800M)$150M

Sales-based milestone payment ($750M)$150M

Sales-based milestone payment(Receipt
expected)Upfront payment
Approval of uHCC*2 indication in Japan
One-time payment for certain option rights
Approval of uHCC indication in the US

FY2018

Approval of uHCC indication in EU
Approval of uHCC indication in China
Sales-based milestone payment ($500M)

FY2019Total payments received

Received $450M as reimbursement for R&D expenses in FY2017
5*1: Merck & Co., Inc ., Kenilworth, N.J., U.S.A. *2: Unresectable hepatocellular carcinoma$1,425M +Progress of Partnership Model

With Merck (2) (Strategic partnership since March 2018)*1- Developed co-commercialization arrangementin 18 countries across the globe- Launched endometrial carcinoma*2,
the first approved indication of KEYTRUDA®+LENVIMA combination in 2019
Initiated pivotal studies in 7 cancer types/11
indications and basket trial (LEAP Studies)
Close cooperation:
CEO level, Development, Regulatory, Medical,
Manufacturing, Commercial®

6

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A. Projects for LENVIMA are under joint
development with Merck & Co., Inc., Kenilworth, N.J., U.S.A. The LEAP studies are led and were submitted by Merck & Co., Inc., Kenilworth, N.J., U.S.A.
*1: Merck & Co., Inc. ., Kenilworth, N.J., U.S.A *2: Advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient who havedisease progression following prior systemic therapy and are not candidates for curative surgery or radiation.

LEAP Study Overview
Breakthrough Therapy Designation- HCC*1 1L PIII, PIb*2
Breakthrough Therapy Designation- RCC*3 1L PIII
Breakthrough Therapy Designation- EC*4 2L PIII
- Melanoma 2L PII- EC 1L PIII
- Melanoma 1L PIII
- NSCLC*5- Basket Trial (PII) *6(Combo with Chemo ) 1L PIII
Gastric Cancer*8- NSCLC (PD-L1+) 1L PIII
Colorectal Cancer- NSCLC 2L PIII
Biliary Tract Cancer- Head&Neck 2L
Ovarian Cancer- Head&Neck 1L PIIITNBC*9- Urothelial 1L PIII
Glioblastoma*7- HCC (Combo with TACE )Large-scale clinical studies for combination therapy planningapprox. 8,200*10 patients with cancer, are steadily ongoing.
Aim to establish KEYTRUDA® + LENVIMA combination as backbone therapy.
®

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A. Projects for Lenvima are under joint development with Merck &Co., Inc., Kenilworth, N.J., U.S.A. The LEAP studies are led and were submitted by Merck & Co., Inc., Kenilworth, N.J., U.S.A. 1L: First line 2L: Second line *1: Hepatocellular carcinoma*2: Study 116 for combination of KEYTRUDA® + Lenvima European Society for Medical Oncology (ESMO) 2019 Abstract #: 747P. Confirmed tumor shrinkage and manageable safety profile*3: Renal cell carcinoma *4: Endometrial cancer *5: Non-small cell lung cancer *6: Chemotherapy *7: Transcatheter Arterial ChemoEmbolization *8: American Society of Clinical Oncology(ASCO-GI) 2020 Abstract #: 374. Confirmed tumor shrinkage and manageable safety profile *9: Triple-negative breast cancer *10: Based on the information disclosed at
7 Gastrointestinal
Clinicaltrials.gov

Progress of Partnership Model

With Nichi-Iko (Strategic partnership since March 2018)
Completed transfer of Elmed Eisai (April 2019)
Established comprehensive strategic
partnership for generic business in China(September 2019)
Initiated supply of API* developed andmanufactured at Eisai Vizag Plant in India to
Nichi-Iko
Proceeded with Integrated Product Package
between Eisai and Nichi-Iko
8* Active pharmaceutical ingredientStatus of EWAY CURRENT
Consolidated P/L
Revenue
COGS rate (%)
R&D

FY2015 results FY2019 forecast CAGR (15-19)
547.9
680.0
5.5%
35.5%
25.0%
148.0
122.3
4.9%
(excluding alliance effects)
188.0
134.2
8.8%
Operating profit
51.9
110.0
20.6%
EPS (1 JPY)
354.6
192.2
16.5%
ROE
15.6%
9.4%
Revenue by region
FY2015 results FY2019 forecast CAGR (15-19)
Japan*
284.9
272.0
-1.2%
US
122.2
135.0
2.5%
China
49.3
70.0
9.2%
EMEA
41.3
51.0
5.4%
Asia and Latin America
34.0
49.0
9.6%
Revenue by focused area FY2015 results FY2019 forecast CAGR (15-19)
Neurology Business
179.7
-0.7%
Oncology Business
118.4
9.5%
Realized huge R&D investment based on the partnership model
Growth of in-house products reduced COGS rate and increased profitability
Asia and Latin America Region and China Region made remarkable progress
Oncology Business drove growthPlan to achieve FY2025 ROE target of 15% or over, ahead of schedule
Plan to achieve FY2020 operating profit target of 102 billion yen ahead of schedule
9* Revenue from OTC and others (Japan) is included. Transfer of Generic business (Elmed Eisai) was completed in April 2019.

(Billions of yen)EWAY
FUTURE(～FY2025)

10

Alzheimer’s Disease (AD) Demography
RegionEU ALL*1

US% ofregionPopulation (million)

Total

2020

331.0
6%
(17%)
55.0 10%
5.9 12.6%
2.4
2.2
4.6
340.4
6%
(19%)
63.5
9%
6.7 12.4%
2.6
2.6
5.2

Total*5
above 65(%)*5
AD All
MCI due to AD*6
Mild AD
Early AD

2025

Total*5
above 65(%)*5
AD All
MCI due to AD*6

Mild AD
Early AD

Total

% of
region

437.4
8%
(19%)
82.7 14%10.7 21.9%
3.8
4.4
8.2
437.8
8%
(21%)
91.6 14%11.8 20.8%
4.1
4.9
9.0

Japan
Total

% of
region

China
Total

% of
regionAsia*2
Total% ofregionROW *3Total% ofregionRegionTotal*4126.5
2% 1,440.0 27% 2,081.4 38% 1,009.8 19% 5,426.0
(28%)
(12%)
(7%)
(7%)
(11%)
35.9
6% 172.3 30% 151.9 27%
74.6 13%572.4
5.6 11.3%
11.6 23.2%
10.3 20.6%
5.1 10.4%
49.1
1.9
4.3
3.8
1.9
18.0
2.3
4.7
4.2
2.1
19.9
4.3
9.0
7.9
3.9
37.9
124.0
2% 1,458.6 26% 2,175.7 39% 1,075.4 19% 5,611.9
(30%)
(14%)
(9%)
(8%)
(12%)
36.7
5% 204.7 30% 186.5 28%
89.6 13%672.6
6.3 11.0%
14.0 24.0%
12.3 21.2%
6.2 10.8%
57.2
2.2
5.1
4.5
2.2
20.7
2.6
5.7
5.0
2.5
23.4
4.9
10.8
9.5
4.8
44.1

The early AD population is estimated as approx. 38 million globally andis expected to be 44 million in 2025.
AD population is estimated to be the largest in China followed by EU ALL and Asia.
The number of people living with AD will increase in all regions through 2025.
The ratio of people aged 65 and over is estimated to be the highest in Japan.

11*1: EU ALL: France, Germany, Italy, Spain, United Kingdom, Austria, Greece, Netherlands, Norway, Poland, Portugal, Sweden, Switzerland, Belgium, Czech Republic,
Denmark, Finland and Russia *2: Asia: Hong Kong, Indonesia, India, South Korea, Australia, New Zealand, Malaysia, Philippines, Singapore, Taiwan, Thailand andVietnam *3: Rest of World: Brazil, Mexico, Argentina, Canada, Chile, Columbia, Venezuela, Egypt, Nigeria, Saudi Arabia, South Africa and Turkey *4 Region Total: US,
EU ALL, Japan, China, Asia and ROW *5: Source: United Nations World Population Prospects 2019, Medium fertility variant *6: Source: Symptomatic Pre-AD based on
Decision Resources 2019

Eliminate Chasms of Disease Understanding,
Preventive Actions, Cognitive Function Check-up andConsultation with Physicians
Chasm : A hurdle, which has to be overcome to promote understanding of disease, making it possible to make a habit ofchecking cognitive function in daily living
MedicaldomainDaily living domain
PeopleUnderstanding of
disease40-79 yearold male Dementia
and female*1

MCI

Preventive action(diet, exercise, sleep, etc.)
UnderstandIndividualized Implement
thepurposeCognitive check-ups

Common Implement
practice

Commonpractice

Medical institutions
Consult withgeneralppractice(millions of people)

65.91

Chasm

51.60

Little awareness orperception of disease

Promote understanding of
disease through diseaseawareness activities

43.96

36.71

13.24

14.03

12.98

Chasm

Preventive behaviors are
not performed as common practice

Chasm(millions of people)

4.81

1.38

Cognitive function
check-up are not performed

0.72

Chasm

Convenient diagnostic tools
for early AD are not widely used

Contributing to make a habit of implementing/checking cognitive
Promote disease prevention*3functions,
including functions in daily living and disease-related areabyand make it aseamlessly
with‘NOUKNOW *4, which has same algorithm as Cognigram
common practice• Promote proper understanding • Preparing a brain performance
App for family members toof dementia and MCI frommanage health against
disease awareness activities
dementia• Promote disease prevention by
on various media, owned
presenting andmedia such as sodan.e65.net*2 recording,measuring brain performance andand through influencers
make it a common practice
12

4.87

Cognitivefunctioncheck-up*1: Internal estimates based on the survey of 1,648 people aged 40-79*2: sodan.e-65.net: Website for disease awareness and provision of information for patientswith dementia and their family run by Eisai (available only in Japanese) *3: Named easiit for
Eisai Dementia Ecosystem Platform. Under review for trademark registration *4: Under review
for trademark registration• Named ‘NOUKNOW’ for Cogstate Brief Battery (non-medicaluse). Measure brain performance by simple card tests on PCs
or tablets, enabling to make a habit of checking cognitive
function in daily living (it only takes 15 minutes for testing),
which may lead to disease preventive action by understanding
brain performance over time.
• Cognigram (medical use) has been approved as a medical
device and is used by medical professionals for diagnosing
MCI and dementia. In Japan, the development as a medical
device for diagnosis of MCI and dementia is underconsideration.

AD Continuum (Continuous Disease Pathology)
and Biomarker Panel

People with no pathologicalchanges

Preclinical AD

MCI due to AD

Mild AD

Moderate AD Severe AD

Definition based on biomarker panel*1*14A

Amyloid

T(I)

Tauopathy (p-tau*3, Tau PET)N

(Aβ42/40, Amyloid PET)

Blood
Amyloid PET
CSF*2
Blood
Tau PET
CSF

Neuroinflammation (sTREM2*4, YKL40*5, TSPO*6 PET)
CSF

Synaptic dysfunction (NfL*7, Neurogranin)

FDG PET*8
CSF

Neurodegeneration (t-tau*9, NfL, vMRI*10)

MRI
CSF

Confirmationof brainperformance

Gene

ApoE genotype and polygenic risk score*11 based on the analysis of SNPs*12

Cognigram*13

Simple confirmation of brain performance to diagnosis utilizing AT(I)N biomarker will eventually be possible.
Diagnosis and efficacy evaluation in AD continuum is based on biomarker panel.
CSF testing will be capable of evaluating AT(I)N biomarkers simultaneously with a high degree of sensitivity.

13*1: The figure above is created based on the lecture at the 39th Annual Meeting of the Japanese Neuroscience Society by Dr. Makoto Higuchi, National Institute of Quantum and Radiological
Science and Technology (Radiological Science and Development Directorate) *2: Cerebrospinal fluid *3: Phosphorylated tau *4: Soluble triggering receptor expressed on myeloid cells 2*5: Chitinase-3-like protein 1 *6: 18kDa translocator protein *7: Neurofilament light chain *8: Positron emission tomography (PET) using fluoro-deoxy-glucose (FDG) *9: Total tau*10: Volumetric MRI *11: Evaluation system for the risk of disease onset with mass information of genetic SNPs as a key index *12: Single-nucleotide polymorphisms *13: Cognigram (global
brand name) is used by medical professionals for diagnosis of MCI and dementia. In Japan, the development as medical devise for diagnosis of MCI and dementia is under consideration.
Cogstate Brief Battery is a simplified version of Cognigram. *14: NOUKNOW: Self-checking tool (non-medical device), which individuals can check their cognitive functions by themselves withquantified brain performance data through simple card games utilizing PC or tablet-type device. Under review for trade mark registration

Future Progress of AD Diagnosis
PET- Transition from “amyloid positivity testing” to“more precise diagnosis of disease stages ”(e.g. preclinical AD) by using amyloid PET
tracer and imaging process with higher
sensitivity and accuracy- Usage as imaging biomarker panel is
expected by using tau-PET tracers

Blood- Co-research with Sysmex on measurement of*1
Aβ1-42/Aβ1-40 with samples from MISSION AD
is ongoing- Diagnosis granted as Breakthrough Devices
Program designation by FDA• APTUSCSF- Diagnosis granted as Breakthrough Devices
Program designation by FDA• Lumipulse® G β-Amyloid (1-42/1-40),
Fujirebio Diagnostics, Inc.
• Elecsys® β-Amyloid (1-42) CSF/p-tau CSF,
F. Hoffmann-La Roche Ltd.

- Precise diagnosis of disease stages andevaluation of drug efficacy utilizing AT(I)N
biomarker panel (CSF) is expected to bepossible

Genetic- Risk diagnosis with polygenic risk score system
is expected based on SNPs*3 analysis,
including ApoE genes status-Aβ blood test, C2N Diagnostics LLC.
p-tau in CSF*2 correlates to p-tau in bloodTM- Pursue low-invasive disease stage diagnosis andevaluation of drug efficacy utilizing AT(I)N biomarker
panel

Aim for paradigm shift in diagnosis with the introduction of blood and genetic testing14*1: MISSION AD: Phase III program for elenbecestat (elenbecestat is a compound under co-development with Biogen) *2: Cerebrospinal fluid*3: Single nucleotide polymorphism

Value of AD DMT*1
Estimated cost for dementia (global total)*2
817.9 billion USD(Approx. 90 trillion yen)
604 billion USD(Approx. 66 trillion yen)

Low income
countries

Informal care cost

20.4 10.4

Middle income
countries
High income
countries

2010

2015

22.6

69.2

19.4

58.0

Medicalcost

Social care cost

19.0

43.1

0%

37.9

50%

• Huge burden on care cost(social care cost and informalcare cost), compared to medical cost
• Cost for dementia was approx. 90
trillion yen worldwide total in 2015,
and it will be estimated to increase toapprox. 220 trillion yen in 2030
100%

Aim forpotential decrease of dementia care cost, including medical/care cost and informal care cost
認知症ケアにかかる費用（医療・介護サービス・家族が行うケア等）の減少
Aducanumab demonstrated
40% reduction*3 in scale
related to activities of dailyliving (ADCS-ADL-MCI) in
early AD patients

Reduction of care costs andcontinuation of economic activities
through improvement of thedegree of independence in dailyliving are expected

Report on potential medical/care cost reduction effect by delaying disease onset of dementia by 5 years

US• It is estimated that if a treatment method would be introduced that delays the onset of dementia by five
years in 2025, it would reduce by 367 billion USD (approx. 40 trillion yen) the total costs of care, including*4
Medicare, Medicaid, co-pay and others) per year in 2050

• Similarly, if a treatment method would be introduced that delays the onset of dementia by five years, it isestimated that medical and nursing cost would be reduced by approx. 1.9 trillion yen (1 trillion yen in medical*5
cost and 900 billion yen) in care cost in fiscal 2025
AD DMT is expected to contribute to not only delaying disease onset/slowing cognitive decline, but also to reducing social cost suchas medical, nursing and informal care cost. AD DMT is also expected to reduce the burden caused by disease onset
by extending the time without symptoms of dementia.

Japan

15

AD: Alzheimer’s Disease *1: Disease modifying treatment for Alzheimer’s Disease *2: Alzheimer‘s Association (2015). Changing the Trajectory of Alzheimer’s Disease: How a treatment by 2025 saves lives and dollars,
total cost of dementia care includes Medicare, Medicaid and self-pay (1USD=110JPY) *3: Topline results of aducanumab EMERGE Study presented at 13th Clinical Trials on Alzheimer’s Disease (CTAD2019)*4: Alzheimer‘s Association (2015). Changing the Trajectory of Alzheimer’s Disease: How a treatment by 2025 saves lives and dollars *5: Tama University, Center for Rule-making Strategies, July 2018

Aβ Hypothesis, Our Understanding
1. BACE inhibitor may be associated with several
substrates other than amyloid precursor protein (APP) as
well as bringing various effects. Therefore, high-selectivity
to APP is required. Potential indication is prevention toaccumulate Aβ aggregates, or maintenance therapy afterAβ aggregates are removed by antibodies.

Amyloid

BACE

2. Less decline of cognitive function and benefits on
activities of daily living by reducing Aβ aggregateswere demonstrated in large-scale studies (Phase II
study of BAN2401*1,2 and Phase III studies(EMERGE/ENGAGE*3) of aducanumab*2)
FibrilAssociation
Dissociation

Intracellular

APP AβExtracellularAβ

Monomerγ-secretase

Dimer

OligomerProtofibrils

Amyloid plaqueMicrotubule

5. Of Aβ aggregates, the
3. Antibodies with selectivity haveneurotoxicity of soluble
been shown to remove Aβ
Tau PhosphorylationTauopathyoftau
aggregates may be
aggregates, compared to anti-Aβ
important. It is also
monomer antibodies or BACE
suggested that there is ainhibitors.
process which directly
The speed of lowering brain Aβ
Neurogranin
Neurofilament forms amyloid plaque frommonomer level, breaking the
Neurodegeneration P-tau, Total tau light chain soluble aggregates.
balance, and dissociating Aβ
aggregates of BACE inhibitors
are slow. Therefore, it is unable to 4. It is important within AD continuum to examine
remove Aβ aggregates rapidly
AT(I)N biomarker panel and tau-PET
and broadly.
16*1: Investigational antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic.
*2: Co-development with Biogen *3: EMERGE/ENGAGE is a Phase III program for aducanumabAducanumab*1 and BAN2401*1,2

Ongoing Studies and Studies under Preparation
Aducanumab
EMBARK Study(Re-dosing study)

Re-dosing of aducanumab (open-label, 2,400 subjects for 100 weeks, 10mg/kg monthly dosing) for
patients who have enrolled OLE of PRIME*3, EMERGE/ENGAGE*4 and EVOLVE*5.

BAN2401
Clarity AD Study
Study 201 OLE

AHEAD 3-45
Study

Subcutaneous
Study

17

Early AD Phase III study (Double blind placebo, 18 months)
1,566 subjects (Placebo：10mg/kg biweekly=1:1)
Primary endpoint: CDR-SB*6, Other endpoints: Cognitive function test, biomarker panel
Initiated in FY2018 4Q, final readout of primary endpoint targeted in Q1 FY2022
BAN2401 open label dosing extension part (Open label study, approx. 200 subjects, 24 months,
10mg/kg biweekly), initiated in Q3 FY2018• Preclinical AD Phase III Study (Double blind placebo, dosing: 4 years, 10mg/kg monthly(maintenance dose))• Includes 2 substudies (A3 and A45) targeting cognitively healthy subjects with different amyloid
levels in the brain• A3 substudy*7: 400 subjects (2 arms, 1:1), Primary endpoint: Aβ PET, Other endpoints: Biomarker
panel*8, PACC5*9• A45 substudy*10: 1,000 subjects (2 arms, 1:1), Primary endpoint: PACC5, Other endpoints:
Biomarker panel*8• Recruitment and enrollment of subjects under common screening protocol to be initiated in 1H
FY2020 in partnership with Alzheimer’s Clinical Trial Consortium (ACTC)
Subcutaneous administration route clinical study (under consideration)

All projects are investigational. *1: Co-development with Biogen *2: Investigational antibody for Alzheimer’s disease produced as the result of a strategic research alliance
between Eisai and BioArctic *3: Open label extension study of Phase Ib study *4: Phase III studies *5: Long-term repetitive administration safety study in participants
with asymptomatic amyloid-related imaging abnormalities (ARIA) in mild cognitive impairment (MCI) or mild Alzheimer's disease dementia *6: Clinical Dementia Rating
Sum of Boxes *7: The A3 substudy will include cognitively normal participants with intermediate levels of amyloid as determined by amyloid PET scan, who are at highrisk for further amyloid build-up *8: Fluid and neuroimaging *9: Preclinical AD Cognitive Composite 5 *10: The A45 substudy will include participants with little to no
cognitive impairment who have elevated levels of amyloid in the brain, who are at high risk for progression to early Alzheimer’s dementia

Development Progress of
Aducanumab*1• Actively engaging with the FDA as well as
regulators in Europe and Japan• Working to complete a regulatory filing in the U.S.
as soon as possible• Plan to initiate open-label re-dosing study(EMBARK Study*) for aducanumab according tosuccessfully submitted protocol to FDA• Implementing a thorough Go-to-market model,
establishing commercial teams, building out
medical teams, and preparing for market access*Re-dosing aducanumab 10mg/kg monthly for patients who enrolled in Phase III
study (ENGAGE, EMERGE), PRIME OLE*2 Study, and EVOLVE Study*3 after titration

18*1: Investigational. Co-development with Biogen *2: Phase Ib study *3: Long-term repetitive administration safety study in participants with asymptomatic amyloidrelated imaging abnormalities (ARIA) in mild cognitive impairment (MCI) or mild Alzheimer's disease dementia

Series of AD-associated Pipeline(Classification by biomarker panel)
Non-clinical

Phase I

Phase II

Phase III

Under preparation
for submission

Anti-Aβ antibody

A
T
(I)
N

Aducanumab*1
Anti-Aβ protofibrils antibody

BAN2401*1,2
Anti-tau antibody

E2814*4
Project

Synapse regenerant

E2511

Preclinical AD: AHEAD 3-45 Study*3
Plan to initiate in 2020

Drug creation based on immune mechanisms in the brain
through discovering target which modulates microglia byleveraging human genetics
Under preparation for Phase I

Synapse modulator*6

Dual orexin receptor antagonist

DAYVIGO
BeyondPDE9 inhibitor
AT(I)N
E2027
pathology Collaborative research with Keio University
EKID*919

Early AD: Clarity AD Study ongoing

Phase I ongoing

Immuno-Dementia*5

EphA4 Project

Under preparation for submission in the US

Non-clinical research in ongoing aimed at maintenance ofmemory through synapse stabilization
ISWRD*7 associated with
AD/dementia: Phase II finished*8
Dementia with Lewy bodies:
Phase II/III ongoing
Drug creation based on protective mechanism of brain
ongoing utilizing reverse translation by leveraging multiomics
analysis of clinical samples

All projects are investigational. AD: Alzheimer’s Disease*1: Co-development with Biogen *2: Antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic *3: A single AD prevention study incollaboration with Alzheimer’s Clinical Trials Consortium (ACTC). *4: Co-research with University College London (UCL), UK *5: Research at G2D2 (Eisai Center for Genetics Guided
Dementia Discovery) *6: Research at KAN Research Institute *7: Irregular sleep-wake rhythm disorder *8: Core study of Phase II has been finished *9: Project aiming to identify and verify
novel drug discovery target candidates linked to the development of next-generation treatments and preventative medicines for dementia at Eisai-Keio Innovation Lab for Dementia (EKID) has
been selected by Japan Agency for Medical Research and Development (AMED) for the Cyclic Innovation for Clinical Empowerment (CiCLE) programStrategy in Cancer Continuum
Precancerous condition/
ultra-early cancer

Liquid biopsy

Early cancer

Advanced cancer
Recurrence/metastasis/gene alteration
associated with treatment resistance

Canceration/proliferation/
gene alteration associated with infiltration

1. Monotherapy Strategy
Induction of neoantigen*1(Splicing modulator ADC*2)
Modulation of Wnt/β-catenin signaling pathway(E7386*3)

Enhance response to tumor immunity at the earlystage of cancer with less mutation
Targeting driver mutation

Target lineage dependency of cancer, driver mutation
and resistance to existing therapy

ERα(H3B-6545)

Target cancer microenvironment that is existingtherapy- resistant and immunosuppressive

Tumor vessel remodeling, tumor stroma improvement andmesenchymal-epithelial transition(MORAb-202, liposomal formulation of eribulin and E7130*5)

FGFR1-3(E7090*4)

FGF19/FGFR4(H3B-6527)

2. Combination Therapy Strategy
Establish combination therapy with KEYTRUDA® as a
backbone therapy by utilizing immunomodulatory activity of
LENVIMA
Enhance reactivity to tumor immunity and unlock resistance toimmuno-oncology therapy
Unlock resistance to existing standard therapy and realize
innovative combination effect

KEYTRUDA® + LENVIMA (LEAP Study)
Eribulin liposomal formulation+ nivolumab*6
Wnt/β-catenin (E7386)+ LENVIMA

STING agonist (E7766)+ immuno-oncology therapy

ERα (H3B-6545)+ standard therapy

FGFR1-3 (E7090)+ standard therapy

Aim at creation of precision medicine and cure of cancer by understanding individual cancer
evolution from “precancerous condition/ultra-early cancer” stage to “advanced cancer” stage®

20

All projects are investigational. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A. Projects for Lenvima areunder joint development with Merck & Co., Inc., Kenilworth, N.J., U.S.A. The LEAP studies are led and were submitted by Merck & Co., Inc., Kenilworth, N.J., U.S.A. *1: Under development incollaboration with H3-Biomedicine, Eisai’s U.S.-based R&D subsidiary and Bristol-Myers Squibb *2: Antibody-drug conjugate *3: Under development in collaboration with PRISM BioLab*4: SAKIGAKE designation granted from Japan’s Ministry of Health, Labour and Welfare *5: Compound co-created with Harvard University *6: Under development in collaboration with Ono
Pharmaceutical Co., Ltd.

Next Flagship Candidates
Target β-catenin, one of “Cancer Big 4”, which isbelieved to have great difficulty in drug creation
Modulation of Wnt/β-catenin signal pathway

E7386*1

H3B-6545

Phase Ib

Wnt

Phase IIWnt signal:
cytoplasm Activation shown inhepatocellular carcinoma,
β-catenincolorectal cancer, gastricnucleus cancer, endometrial*2
CBP β-catenincancer and others cancer
transcription
×types
Targetgene

E7386 suppresses Wnt signal-dependent cancerationand proliferation of cancer cells by blocking
transcription through inhibiting
protein-protein interaction of CBP-β-catenin

E7386

21

- Although ER positive breast cancer
accounts for approx. 70% in all breast
cancer, treatment resistant ERα genemutant cells are observed in approx. 30%
patients after a long-term administration ofaromatase inhibitors*3- ERα gene mutant cells includes cells whichshow resistance to SERM*4 and SERD*5
H3B-6545 covalently inhibits downstream
signal and suppress proliferation of breast cancer cells
in both wild type and mutant type of ERα
Regimen for ER positive breast cancer

HCC Continuum
Precancerous condition/
Early cancer
ultra-early cancer
Genetic alteration of Wnt/β-cateninsignal pathway

Aim to reform endocrine therapy for estrogen
receptor (ER) positive breast cancer
Selective estrogen receptor (ER) α covalentantagonist

Advanced cancer

KEYTRUDA®+LENVIMA

Endocrine therapy
Molecular target treatment

Chemotherapy

H3B-6545

HALAVEN

Existing endocrine therapy-resistantERα gene mutation

All projects are investigational. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A. Projects for LENVIMA are underjoint development with Merck & Co., Inc., Kenilworth, N.J., U.S.A. The LEAP studies are led and were submitted by Merck & Co., Inc., Kenilworth, N.J., U.S.A. *1: Under development incollaboration with PRISM BioLab *2: CREB-Binding Protein. One of transcriptional control factors *3: Jeselsohn R. et al. Curr Oncol Rep 2017 *4: Selective Estrogen Receptor Modulator*5: Selective Estrogen Receptor Degrader

Origin of Eisai

22

Empathy

Extracting
anxieties

Trying strategy

Creating strategy tosatisfy anxieties

Spending Time with Patients‘Empathy’ beyond language/generation

1. Relief supplies to cancer
patients at the time of hurricane
damage (Puerto Rico)

5. Socialization withpeople with Parkinson’s disease(Tokyo, Japan)

23

2. Socialization with people with
Lymphatic Filariasis(Betun Malaka, Indonesia)

3. Socialization withelderly people with insomnia(Kyoto prefecture, Japan)

6. Socialization in a group home for the mentally handicapped(Shizuoka prefecture, Japan)

4. Socialization in apediatric cancer ward
(Tokyo, Japan)

7. Socialization withpeople with epilepsy(Kanagawa prefecture,
Japan)

Empathy: Status of intersubjectivity of the feelings with other persons,which may create mutual trustAD Strategy

Spending time with people
living with dementia andtheir family

Trying strategy that would
bring benefits to people
living with dementia

24

Three anxieties
1.When will future risks surface?
2.What should I do to avoid risks?
3.I don’t want to be a burden
on my family

Designing dementia
ecosystem platform
as a strategy tosatisfy the hypothesis

Named Eisai Platform as*1

People living with Dementia
and their families
Information on
Prediction andPrevention

People’s information
Cognitive function
in daily living- For general public, establish- Information aboutalgorithm for prediction andcognitive function checked prevention and provide it as
Designing insurance
Privatewith “NOUKNOW”, sleep, easy-to-use apps
products including- For HCP, establish algorithm
diet, and exercise
Insurance information to preventto support disease
dementia
Compliance withrelated rules and classification, prediction for
Exercise program forregulations, such as disease progression, andprediction for treatment effectFitness maintaining/improving
Personal Information
解析
for medical institutions
cognitivefunctionProtection Law
club- Dataset of cognitive function data andbiomarker data obtained from clinical studies of
Safety driving bydementia treatments, including AD DMT*2
elderly people- Tracking cohort data of healthy status to MCI
Automobile (Connected Car)
Expansion of stage

Manufacturer

employment in over-thecounter operations for Support to create
elderly people
optimal care

Retailbusiness

Societal

25

programs andmatching of users

Nursinghome

Support for sharing
patient life logs,
optimal diagnosis andtreatment intervention
mix, etc.
Improvement of
accuracy in diagnostic
measurement
technology andprediction of cognitive
function

Creating innovation bycreating and utilizing
high-quality data

Universities, Research
Organizations,and Bio-venture

Medicalinstitution

Diagnostic tool

AMED
and PMDA

MedicoRealization of Societal Innovation through Dementia Ecosystem*1: Trademark registration application under review. Under preparation for launch in Japan *2: Disease modifying treatment for AD

EWAY FUTURE Aspiration
Overall CAGREWAY CURRENT
5.5%

20%

Operating profit

20.6%

25%

Neurology Business*4

-0.7%

45%

Oncology Business*4

9.5%

25%

10000

*2,3

Region Balance

Revenue

15000

EWAY FUTURE

Revenue

25000
20000

*1

Japan
Americas
China
EMEA
Asia and Latin America

5000
0FY2015FY2019
47%
24%
12%
9%
8%

CURRENTFY2025*3
25%
50%
10%
7%
8%

Forecast for
FY2019FY2025

Aim for remarkable growth with expansion of LENVIMA and potential AD DMT*5
during EWAY FUTURE.
Americas region is major driver for the whole company.
26

Tables shown above are estimated growth prediction, not an official forecast. Official forecast is disclosed in Consolidated Annual Financial Reports.
*1: During FY2015 to FY2019 (forecast) *2: During FY2019 (forecast) to FY2025 (numbers are approximate) *3: Round numbers *4: Revenue by focused area
*5: Disease Modifying Treatment for Alzheimer’s Disease

EWAY POINTS
Partnership Model has been andwill be the core of our businessthrough EWAY

Transforming Medico Innovation
to Societal Innovation is
the Task of EWAY FUTURE
27

“MEDICO SOCIETAL INNOVATOR, Eisai”
2025

ATTACK
CAMP
CAMP III

CAMP IICAMP I

BASE
CAMP

28

Source: https://en.wikipedia.org/wiki/File:Everest_kalapatthar_crop.jpg

2016