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March 6, 2020 Eisai Co., Ltd Information Meeting

March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

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Page 1: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

March 6, 2020

Eisai Co., Ltd

Information Meeting

Page 2: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

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 and

uncertainties 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 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 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 a

result 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 shall

prevail.

The Company discloses its consolidated financial statements according to the International Financial Reporting

Standards (IFRS).

Page 3: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

• Plan ‘EWAY 2025’ is the mid-term business

plan from FY2016 to FY2025

• We have positioned the period of FY2016 to

FY2019 as “EWAY CURRENT” and reviewed

• We have positioned the period of FY2020 to

FY2025 as “EWAY FUTURE” and analyzed

Plan ‘EWAY 2025’

Converting Knowledge into Business

We Make Medicines, We Make Solutions

through Eisai’s WAY

1

Page 4: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

EWAY

CURRENT

(FY2016~FY2019)

2

Page 5: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

EWAY 2025 Strategic Intents

“Therapeutic Areas of Focus”,

“Transformation of Business Portfolio”

and “ ‘Ricchi’ and Innovation”

Creation of Neurology and

Oncology Business Groups

Progress to Partnership Model

3

Page 6: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

Progress of Partnership Model

With Biogen

*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 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

(Strategic partnership originally established in March 2014

and expanded in October 2017)

4

Page 7: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

Progress of Partnership Model

- All planned milestones are expected to be achieved based on

steady progress of collaboration regarding LENVIMA

FY2017

Upfront payment $300M

Approval of uHCC*2

indication in Japan $25M

FY2018

One-time payment for certain option rights $325M

Approval of uHCC indication in the US $125M

Approval of uHCC indication in EU $75M

Approval of uHCC indication in China $25M

Sales-based milestone payment ($500M) $50M

FY2019

One-time payment for certain option rights $200M

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

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

Sales-based milestone payment(Receipt

expected)

Total payments received $1,425M +

Received $450M as reimbursement for R&D expenses in FY2017

With Merck*1

(1) (Strategic partnership since March 2018)

*1: Merck & Co., Inc ., Kenilworth, N.J., U.S.A. *2: Unresectable hepatocellular carcinoma5

Page 8: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

Progress of Partnership Model

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 have

disease progression following prior systemic therapy and are not candidates for curative surgery or radiation.

With Merck*1

(2) (Strategic partnership since March 2018)

Close cooperation:

CEO level, Development, Regulatory, Medical,

Manufacturing, Commercial

- Developed co-commercialization arrangement

in 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)

6

Page 9: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

- HCC*1

1L PIII, PIb*2

- RCC*3

1L PIII

- EC*4

2L PIII

- Melanoma 2L PII

- EC 1L PIII

- Melanoma 1L PIII

- NSCLC*5

(Combo with Chemo*6

) 1L PIII

- NSCLC (PD-L1+) 1L PIII

- NSCLC 2L PIII

- Head&Neck 2L

- Head&Neck 1L PIII

- Urothelial 1L PIII

- HCC (Combo with TACE*7

)

Breakthrough Therapy Designation

Breakthrough Therapy Designation

Breakthrough Therapy Designation

LEAP Study Overview

- Basket Trial (PII) -

Gastric Cancer*8

Colorectal Cancer

Biliary Tract Cancer

Ovarian Cancer

TNBC*9

Glioblastoma

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 Gastrointestinal (ASCO-GI) 2020 Abstract #: 374. Confirmed tumor shrinkage and manageable safety profile *9: Triple-negative breast cancer *10: Based on the information disclosed at Clinicaltrials.gov

Large-scale clinical studies for combination therapy planning

approx. 8,200*10 patients with cancer, are steadily ongoing.

Aim to establish KEYTRUDA®

+ LENVIMA combination as backbone therapy.

7

Page 10: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

With Nichi-Iko (Strategic partnership since March 2018)

Progress of Partnership Model

* Active pharmaceutical ingredient

Completed transfer of Elmed Eisai (April 2019)

Established comprehensive strategic

partnership for generic business in China

(September 2019)

Initiated supply of API* developed and

manufactured at Eisai Vizag Plant in India to

Nichi-Iko

Proceeded with Integrated Product Package

between Eisai and Nichi-Iko

8

Page 11: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

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%

Consolidated P/L FY2015 results FY2019 forecast CAGR (15-19)

Revenue 547.9 680.0 5.5%

COGS rate (%) 35.5% 25.0% -

R&D 122.3 148.0 4.9%(excluding alliance effects) 134.2 188.0 8.8%

Operating profit 51.9 110.0 20.6%

EPS (1 JPY) 192.2 354.6 16.5%

ROE 9.4% 15.6% -

(Billions of yen)

Realized huge R&D investment based on the partnership modelGrowth of in-house products reduced COGS rate and increased profitability

Asia and Latin America Region and China Region made remarkable progressOncology Business drove growth

Plan to achieve FY2025 ROE target of 15% or over, ahead of schedulePlan to achieve FY2020 operating profit target of 102 billion yen ahead of schedule

* Revenue from OTC and others (Japan) is included. Transfer of Generic business (Elmed Eisai) was completed in April 2019.

Status of EWAY CURRENT

9

Page 12: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

EWAY

FUTURE

(~FY2025)

10

Page 13: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

Region

Population (million)

US EU ALL*1 Japan China Asia*2 ROW*3

Region

Total*4Total% of

regionTotal

% of

regionTotal

% of

regionTotal

% of

regionTotal

% of

regionTotal

% of

region

2020 Total*5 331.0 6% 437.4 8% 126.5 2% 1,440.0 27% 2,081.4 38% 1,009.8 19% 5,426.0

above 65(%)*5(17%)

55.0 10%

(19%)

82.7 14%

(28%)

35.9 6%

(12%)

172.3 30%

(7%)

151.9 27%

(7%)

74.6 13%

(11%)

572.4

AD All 5.9 12.6% 10.7 21.9% 5.6 11.3% 11.6 23.2% 10.3 20.6% 5.1 10.4% 49.1

MCI due to AD*6 2.4 3.8 1.9 4.3 3.8 1.9 18.0

Mild AD 2.2 4.4 2.3 4.7 4.2 2.1 19.9

Early AD 4.6 8.2 4.3 9.0 7.9 3.9 37.9

2025 Total*5 340.4 6% 437.8 8% 124.0 2% 1,458.6 26% 2,175.7 39% 1,075.4 19% 5,611.9

above 65(%)*5(19%)

63.5 9%

(21%)

91.6 14%

(30%)

36.7 5%

(14%)

204.7 30%

(9%)

186.5 28%

(8%)

89.6 13%

(12%)

672.6

AD All 6.7 12.4% 11.8 20.8% 6.3 11.0% 14.0 24.0% 12.3 21.2% 6.2 10.8% 57.2

MCI due to AD*6 2.6 4.1 2.2 5.1 4.5 2.2 20.7

Mild AD 2.6 4.9 2.6 5.7 5.0 2.5 23.4

Early AD 5.2 9.0 4.9 10.8 9.5 4.8 44.1

The early AD population is estimated as approx. 38 million globally and

is 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. *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 and

Vietnam *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

Alzheimer’s Disease (AD) Demography

11

Page 14: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

Daily living domain

Preventive behaviors are

not performed as common practice

Convenient diagnostic tools

for early AD are not widely used

Preventive action(diet, exercise, sleep, etc.)Understanding of

disease Cognitive check-ups

Promote understanding of disease through disease

awareness activities• Promote proper understanding

of dementia and MCI from

disease awareness activities

on various media, owned

media such as sodan.e65.net*2

and through influencers

Promote disease prevention by *3 and make it a

common practice • Preparing a brain performance

App for family members to manage health against dementia

• Promote disease prevention by recording, presenting and measuring brain performance and make it a common practice

Little awareness or

perception of disease

Chasm ChasmCognitive function

check-up are not performed

Chasm Chasm

Eliminate Chasms of Disease Understanding,

Preventive Actions, Cognitive Function Check-up and

Consultation with Physicians

Chasm : A hurdle, which has to be overcome to promote understanding of disease, making it possible to make a habit of

checking cognitive function in daily living

Medical

domain

(millions of people)(millions of people)

Dementia MCIUnderstand

the purpose

Individualized Implement Common

practiceImplement

People

40-79 year-old male

and female*1

Medical institutions

Consult with

general

ppractice

Cognitive

function

check-up

65.91 51.60 43.96 36.71 13.24 14.03 12.98 4.87 1.384.81

0.72

*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 patients with 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

12

Common

practice

• Named ‘NOUKNOW’ for Cogstate Brief Battery (non-medical use). 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 under consideration.

Contributing to make a habit of implementing/checking cognitive functions, including functions in daily living and disease-related area

seamlessly with ‘NOUKNOW*4, which has same algorithm as Cognigram

Page 15: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

A

N

T

CSF*2

Amyloid PET

Tau PET

CSF

CSF

CSF

CSF

MRI

(I)

FDG PET*8

Blood

Blood

*14

Amyloid

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.

(Aβ42/40, Amyloid PET)

Neuroinflammation (sTREM2*4

, YKL40*5

, TSPO*6

PET)

Synaptic dysfunction (NfL*7

, Neurogranin)

Neurodegeneration (t-tau*9

, NfL, vMRI*10

)

Tauopathy (p-tau*3

, Tau PET)

Cognigram*13

AD Continuum (Continuous Disease Pathology)

and Biomarker Panel

Mild AD Severe ADPreclinical AD Moderate AD MCI due to ADPeople with no pathological

changes

Confirmation

of brain

performance

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

Definition based on biomarker panel*1

*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 with quantified brain performance data through simple card games utilizing PC or tablet-type device. Under review for trade mark registration 13

Page 16: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

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

CSF

BloodGenetic

Future Progress of AD Diagnosis

- 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 and

evaluation of drug efficacy utilizing AT(I)N

biomarker panel (CSF) is expected to be

possible

- Risk diagnosis with polygenic risk score system

is expected based on SNPs*3 analysis,

including ApoE genes status

*1: MISSION AD: Phase III program for elenbecestat (elenbecestat is a compound under co-development with Biogen) *2: Cerebrospinal fluid

*3: Single nucleotide polymorphism

- Co-research with Sysmex on measurement of

Aβ1-42/Aβ1-40 with samples from MISSION AD*1

is ongoing

- Diagnosis granted as Breakthrough Devices

Program designation by FDA• APTUSTM,

-Aβ blood test, C2N Diagnostics LLC.

- p-tau in CSF*2 correlates to p-tau in blood

- Pursue low-invasive disease stage diagnosis and

evaluation of drug efficacy utilizing AT(I)N biomarker

panel

Aim for paradigm shift in diagnosis with the introduction of blood and genetic testing

14

Page 17: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

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

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

Medicare, Medicaid, co-pay and others) per year in 2050*4

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

• Similarly, if a treatment method would be introduced that delays the onset of dementia by five years, it is

estimated that medical and nursing cost would be reduced by approx. 1.9 trillion yen (1 trillion yen in medical

cost and 900 billion yen) in care cost in fiscal 2025*5

Estimated cost for dementia (global total)*2

Value of AD DMT*1

Aim for potential decrease of dementia care cost, including medical/care cost and informal care cost

• Huge burden on care cost

(social care cost and informal

care cost), compared to medical cost

• Cost for dementia was approx. 90

trillion yen worldwide total in 2015,

and it will be estimated to increase to

approx. 220 trillion yen in 2030

2010 2015

High incomecountries

604 billion USD

(Approx. 66 trillion yen)

817.9 billion USD

(Approx. 90 trillion yen)

Middle incomecountries

Low incomecountries

20.4

22.6

19.0

10.4

19.4

43.1

69.2

58.0

37.9

0% 50% 100%

Medical cost

Social care cost

Informal care cost

Aducanumab demonstrated

40% reduction*3 in scale

related to activities of daily

living (ADCS-ADL-MCI) in

early AD patients

Reduction of care costs and

continuation of economic activities

through improvement of the

degree of independence in daily

living are expected

Japan

AD DMT is expected to contribute to not only delaying disease onset/slowing cognitive decline, but also to reducing social cost such as 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. 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 15

Page 18: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

Aβ Hypothesis, Our Understanding

2. Less decline of cognitive function and benefits on

activities of daily living by reducing Aβ aggregates

were demonstrated in large-scale studies (Phase II

study of BAN2401*1,2 and Phase III studies

(EMERGE/ENGAGE*3) of aducanumab*2)

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 to accumulation of Aβ aggregates, or maintenance therapy after Aβ aggregates are removed by antibodies.

*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

AP

P

BACEAssociation

Dissociation

Extracellular

Intracellular γ-secretase

Aβ Amyloid plaqueDimer Oligomer Protofibrils

Fibril

Monomer

Microtubule

Tau Phosphorylation

of tau

Neurofilamentlight chain

NeurograninP-tau, Total tau

Amyloid

Tauopathy

Neurodegeneration

5. Of Aβ aggregates, the neurotoxicity of soluble aggregates may be important. It is also suggested that there is a process which directly forms amyloid plaque from soluble aggregates.

4. It is important within AD continuum to examine

AT(I)N biomarker panel and tau-PET

3. Antibodies with selectivity have been shown to remove Aβ aggregates, compared to anti-Aβ monomer antibodies or BACE inhibitors.The speed of lowering brain Aβ monomer level, breaking the balance, and dissociating Aβ aggregates of BACE inhibitors are slow. Therefore, it is unable to remove Aβ aggregates rapidly and broadly.

16

Page 19: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

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.

Clarity AD Study

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 panelInitiated in FY2018 4Q, final readout of primary endpoint targeted in Q1 FY2022

Study 201 OLEBAN2401 open label dosing extension part (Open label study, approx. 200 subjects, 24 months, 10mg/kg biweekly), initiated in Q3 FY2018

AHEAD 3-45

Study

• 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

Study

Subcutaneous administration route clinical study (under consideration)

BAN2401

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 high risk 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 dementia17

Page 20: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

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 to

successfully 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

*1: Investigational. Co-development with Biogen *2: Phase Ib study *3: 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 18

Page 21: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

Non-clinical Phase I Phase II Phase IIIUnder preparation

for submission

Series of AD-associated Pipeline

(Classification by biomarker panel)

Anti-Aβ protofibrils antibody

BAN2401*1,2

Anti-tau antibody

E2814*4

Synapse modulator

EphA4 Project*6

Synapse regenerant

E2511

Anti-Aβ antibody

Aducanumab*1

A

TImmuno-Dementia

*5

Project(I)

N

Dual orexin receptor antagonist

DAYVIGO

PDE9 inhibitor

E2027

Collaborative research with Keio University

EKID*9

Preclinical AD: AHEAD 3-45 Study*3

Plan to initiate in 2020

Phase I ongoing

Under preparation for Phase I

Under preparation for submission in the US

Early AD: Clarity AD Study ongoing

ISWRD*7 associated with

AD/dementia: Phase II finished*8

Dementia with Lewy bodies:

Phase II/III ongoing

Drug creation based on immune mechanisms in the brain through discovering target which modulates microglia by leveraging human genetics

Drug creation based on protective mechanism of brain ongoing utilizing reverse translation by leveraging multiomics analysis of clinical samples

Non-clinical research in ongoing aimed at maintenance of memory through synapse stabilization

Beyond

AT(I)N

pathology

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 in collaboration 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 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

19

Page 22: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

1. Monotherapy Strategy

Targeting driver mutation

Enhance response to tumor immunity at the early

stage of cancer with less mutation

Target lineage dependency of cancer, driver mutation

and resistance to existing therapy

Target cancer microenvironment that is existing-

therapy- resistant and immunosuppressive

Induction of neoantigen*1

(Splicing modulator ADC*2)

Modulation of Wnt/β-catenin signaling pathway (E7386*3)

FGFR1-3(E7090*4)

ERα(H3B-6545)

FGF19/FGFR4(H3B-6527)

Tumor vessel remodeling, tumor stroma improvement and mesenchymal-epithelial transition

(MORAb-202, E7389-Liposomal formulation and E7130*5)

2. Combination Therapy StrategyEstablish combination therapy with KEYTRUDA® as a backbone therapy by utilizing immunomodulatory activity of LENVIMA

Wnt/β-catenin (E7386) + LENVIMA

KEYTRUDA®

+ LENVIMA (LEAP Study)

ERα (H3B-6545)+ standard therapy

FGFR1-3 (E7090)+ standard therapy

Eribulin liposomal formulation

+ nivolumab*6

STING agonist (E7766)+ immuno-oncology therapy

Enhance reactivity to tumor immunity and unlock resistance to

immuno-oncology therapy

Unlock resistance to existing standard therapy and realize

innovative combination effect

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” stageAll 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

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: Under development in

collaboration 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.

Strategy in Cancer Continuum

Advanced cancerEarly cancerPrecancerous condition/

ultra-early cancer

Liquid biopsy Canceration/proliferation/

gene alteration associated with infiltration

Recurrence/metastasis/gene alteration

associated with treatment resistance

20

Page 23: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

- Although ER positive breast cancer

accounts for approx. 70% in all breast

cancer, treatment resistant ERα gene

mutant cells are observed in approx. 30%

patients after a long-term administration of

aromatase inhibitors*3

- ERα gene mutant cells includes cells which

show resistance to SERM*4 and SERD*5

Next Flagship Candidates

Aim to reform endocrine therapy for estrogen

receptor (ER) positive breast cancer

Wnt

Wnt signal:

target

gene

nucleusCBP*2 β-catenin

×

β-catenin

cytoplasm Activation shown in

hepatocellular carcinoma,

colorectal cancer, gastric

cancer, endometrial

cancer and others cancer

types

Precancerous condition/

ultra-early cancerEarly cancer Advanced cancer

HCC Continuum

Genetic alteration of Wnt/β-catenin signal pathway

Regimen for ER positive breast cancerHormone therapy

Chemotherapy

E7386KEYTRUDA

®+LENVIMA H3B-6545

Existing hormone therapy-resistant ERα gene mutation

Modulation of Wnt/β-catenin signal pathway

E7386*1

Target β-catenin, one of “Cancer Big 4”, and

said to have great difficulty in drug creation Selective estrogen receptor (ER) α covalent

antagonist

H3B-6545

translation

Molecular target treatment

HALAVEN

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 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: Under development in collaboration 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

E7386 blocks translation by inhibiting

protein-protein interaction of CBP-β-catenin, and

suppresses Wnt signal dependent canceration and

proliferation of cancer cells

H3B-6545 covalently inhibits downstream

signal and suppress proliferation of breast cancer cells

in both wild type and mutant type of ERα

21

Phase Ib Phase II

Page 24: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

Origin of Eisai

Empathy Extracting

anxieties

Trying strategy Creating strategy to

satisfy anxieties

22

Page 25: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

Spending Time with Patients

‘Empathy’ beyond language/generation

2. Socialization with people with

Lymphatic Filariasis

(Betun Malaka, Indonesia)

1. Relief supplies to cancer

patients at the time of hurricane

damage (Puerto Rico)

Empathy: Status of intersubjectivity of the feelings with other persons,

which may create mutual trust

4. Socialization in a

pediatric cancer ward

(Tokyo, Japan)

6. Socialization in a group home for the mentally handicapped

(Shizuoka prefecture, Japan)

7. Socialization with

people with epilepsy

(Kanagawa prefecture,

Japan)

5. Socialization with

people with Parkinson’s disease

(Tokyo, Japan)

3. Socialization with

elderly people with insomnia

(Kyoto prefecture, Japan)

23

Page 26: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

AD Strategy

Spending time with people

living with dementia and

their family

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

Trying strategy that would

bring benefits to people

living with dementia

Designing dementia

ecosystem platform

as a strategy to

satisfy the hypothesis

24

Page 27: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

AMED

and PMDA

解析

Named Eisai Platform as

Compliance with related rules and

regulations, such as Personal Information

Protection Law

Societal

People living with Dementia

and their families

People’s information

Cognitive function

in daily living

Information on

Prediction and

Prevention

- Information about

cognitive function checked

with “NOUKNOW”, sleep,

diet, and exercise

- For general public, establish

algorithm for prediction and

prevention and provide it as

easy-to-use apps

- For HCP, establish algorithm

to support disease

classification, prediction for

disease progression, and

prediction for treatment effect

for medical institutions

- Dataset of cognitive function data and

biomarker data obtained from clinical studies of

dementia treatments, including AD DMT*2

- Tracking cohort data of healthy status to MCI

stage

Support for sharing

patient life logs,

optimal diagnosis and

treatment intervention

mix, etc.

Support to create

optimal care

programs and

matching of users

Improvement of accuracy in diagnostic

measurement technology and

prediction of cognitive function

Medical

institution

Creating innovation by

creating and utilizing

high-quality data

Universities, Research

Organizations,

and Bio-venture

Expansion of

employment in over-the-

counter operations for

elderly people

Safety driving by

elderly people

(Connected Car)

Exercise program for

maintaining/improving

cognitive function

Diagnostic tool

Retail

business

Automobile

Manufacturer

Fitness club

Private

Insurance

Designing insurance

products including

information to prevent

dementia

Medico

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

*1

Nursing

home

25

Page 28: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

0

5000

10000

15000

20000

25000

FY2015 Forecast forFY2019

FY2025

EWAY FUTURE Aspiration

Overall CAGR

EWAY CURRENT*1

EWAY FUTURE*2,3

Revenue 5.5% 20%

Operating profit 20.6% 25%

Neurology Business*4 -0.7% 45%

Oncology Business*4 9.5% 25%

CURRENT

Region Balance

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.

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

Revenue FY2019 FY2025*3

Japan 47% 25%

Americas 24% 50%

China 12% 10%

EMEA 9% 7%

Asia and Latin America 8% 8%

26

Page 29: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

EWAY POINTS

Partnership Model has been and

will be the core of our business

through EWAY

Transforming Medico Innovation

to Societal Innovation is

the Task of EWAY FUTURE

27

Page 30: March 6, 2020 Eisai Co., Ltd · • Plan ‘EWAY 2025’ is the mid-term business plan from FY2016 to FY2025 • We have positioned the period of FY2016 to FY2019 as “EWAY CURRENT”

“MEDICO SOCIETAL INNOVATOR, Eisai”

BASE

CAMP

CAMP III

2025

CAMP I

CAMP II

ATTACK

CAMP

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

2016

28