(Fiscal Year Ended March 31, 2019) Financial Results Presentation · 2019-05-14 · FY2018 (Fiscal...

FY2018

(Fiscal Year Ended March 31, 2019)

Financial Results Presentation

Eisai Co., Ltd.

May 13, 2019

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).

1

FY2018 Consolidated Statement of Income (IFRS)

LENVIMA’s high potential blossomed globally and

contributed to the results

FY2017 FY2018

Results % Results % YoY

Revenue 600.1 100.0 642.8 100.0 107

Cost of sales 201.3 33.5 184.5 28.7 92

Gross profit 398.8 66.5 458.3 71.3 115

R&D expenses 139.6 23.3 144.8 22.5 104

Partners’ share of R&D expenses 158.5 26.4 191.3 29.8 121

SG&A expenses 183.9 30.6 228.2 35.5 124

Other income & expenses 1.8 0.3 0.9 0.1 47

Operating profit 77.2 12.9 86.2 13.4 112

Profit for the year 54.4 9.1 66.5 10.3 122 Profit for the year (Attributable to owners of the parent)

51.8 8.6 63.4 9.9 122

ROE (%) 8.8 10.4

Free cash flows*1 136.7 85.1

End of March 2018 End of March 2019

Net DER*2

- 0.27 - 0.32

Ratio of equity attributable to owners of

the parent (%) 56.6 58.6

(Billions of yen, %)

FY2018 average exchange rates: 1 USD: 110.90 yen (-0.0% YoY), 1 EUR: 128.40 yen (-1.0% YoY), 1 GBP: 145.67 yen (-0.9% YoY), 1 RMB: 16.53 yen (-1.3% YoY)

*1: Free cash flow = (Net cash from operating activities) – (Capital expenditures (cash basis))

(Note) Expenditures from purchases of financial assets and proceeds from sale and redemption of financial assets are included in the formula used to calculate capital expenditures.

*2: (Net DER)=("Interest-bearing debt" ("Bonds and borrowings") - "Cash and cash equivalents" - "Time deposits exceeding three months, etc.“ - “Investment securities held by the parent company") / "Equity

attributable to owners of the parent"

600.1

642.8

5,500

6,000

6,500

2017年度

売上収益

グローバル

ブランド

日本事業中国・アジアレンビマ関連

受領金

Aloxiの減収その他 2018年度

売上収益

(Billions of yen)

2

+28.9

+42.8 B yen

YoY

*1

+10.3 +4.9

+31.0 -37.8

+5.5

*2

<Factors for increase>

Divesture of Prialt

Divesture of Salagen

and Panretin

<Factors for increase> Milestone payments for the approvals of HCC*3

indication in US, EU and China 22.2 Milestone payment for the reimbursement

approval for HCC in EU 2.8 Lump sum payment for certain option rights 35.0 Sales-based milestone payment 5.5

<Factors for decrease> Upfront payment in FY2017 - 31.8 Milestone payment for the approval of HCC

indication in Japan in FY2017 - 2.7

Breakdown of Revenue Migration

Revenue increased through growth of global brands, business in Japan and

China/Asia, in addition to recognition of payments associated with LENVIMA

650

600

FY2017

Revenue FY2018

Revenue Global brands*1 Japan

business China and

Asia business*2

Decrease in

Aloxi

revenue

Others Recognition of

payments associated with

LENVIMA

650

550

* Figures shown in breakdown are approximate. *1: Revenue of LENVIMA, Halaven, Fycompa and BELVIQ, excluding revenue of Japan business

*2: Revenue of China and Asia and Latin America region, excluding revenue of global brands *3: Hepatocellular carcinoma

<Amount increased>

LENVIMA 23.4

Fycompa 3.4

Halaven 1.2

BELVIQ 0.9

<Factors for decrease>

Drug price revision

in Japan -18.2


Growth of LENVIMA,

Humira, Lyrica and others

Return of marketing rights

for Lipacreon

3

77.2 86.2

0

500

1,000

2017年度営業利益グローバルブランドの拡大日本事業中国・アジアの拡大レンビマ受領金研究開発費の増加 Aloxiの減益その他の増減 2018年度営業利益

139.6 144.8

18.9

46.4 158.5

191.3

FY2017 FY2018

Partners' share of R&D cost

R&D cost+0.3 +8.1

+31.0 -5.3 -15.3

-32.4

+8.9B yen

YoY

Recognition of payments associated with LENVIMA


Milestone payments for the approvals of

HCC*4

indication in US, EU and China 22.2

Milestone payment for the reimbursement

approval for HCC in EU 2.8

Lump sum payment for certain option

rights 35.0

Sales-based milestone payment 5.5


Divesture of Prialt

Divesture of Salagen and Panretin


Profit sharing associated with strategic

partnership with Merck & Co., Inc.,

Kenilworth, N.J., U.S.A.


Upfront payment in FY2017 - 31.8

Milestone payment for the approval of

HCC indication in Japan in FY2017

- 2.7

FY2017

Operating profit

Global

brands*1

Japan

business

China and Asia

business*2

Decrease

in Aloxi

profit*3

Others FY2018

Operating profit

Recognition of payments

associated with LENVIMA

Increase in

R&D expenses

(Billions of yen)

100

50

(Reference)

R&D expenses inclusive of

partners’ share of cost (Billions of yen)

Breakdown of Operating Profit Migration

Operating profit increased through growth of global brands, business in Japan,

China and Asia, in addition to recognition of payments associated with LENVIMA,

and proactively invested in R&D through partnership model

* Figures shown in breakdown are approximate *1: Operating profit from LENVIMA, Halaven, Fycompa and BELVIQ, excluding profit of Japan business

*2: Operating profit from business in China, and Asia and Latin America, excluding profit of global brands *3: Operating profit of Aloxi *4: Hepatocellular carcinoma

4

Aim for Further Global Growth in FY2019

*1: Unresectable hepatocellular carcinoma *2: Transcatheter arterial chemoembolization

1.5 4.0 4.0 3.1

9.0 5.8

8.0

12.0

3.0

10.0

13.0

21.9

37.5

78.0

FY2017 results FY2018 results FY2019 forecast

Americas

Japan

EMEA

China

Asia and Latin America

Revenue of LENVIMA (Billions of yen)

116.0B yen (185% YoY)

62.6 B yen (194%YoY)

32.2 B yen

• Aim for expansion of share in countries where uHCC indication was approved, and high growth through expansion of newly approved countries and reimbursement

EMEA 12.0B yen (150% YoY)

• Aim to maximize contribution to patients in China, where the largest number of

patients diagnosed with uHCC are located

• Further maximize access after national reimbursement drug listing

• Leverage Patient Access Program in place to facilitate treatment initiation

China 9.0B yen (289% YoY)

• Seeking LENVIMA’s potential of conversion to curative treatment in

liver cancer, such as resection, radiofrequency ablation or TACE*2,

and aim to accelerate growth utilizing the reports from real world

setting in Japan

Japan 13.0B yen (131% YoY)

• Aim for expansion of share in multiple indications including 1st line

uHCC*1, and enormous growth through maximization of effect of

collaboration with Merck & Co., Inc., Kenilworth, N.J., U.S.A.

Americas 78.0B yen (208% YoY)

Aim for LENVIMA’s value maximization (revenue forecast of 116.0 B yen, 185% YoY) and

expansion of patient contribution, through further increase of collaboration in countries,

including countries where Merck & Co., Inc., Kenilworth, N.J., U.S.A. has more capabilities

5

Progress of Collaboration with

Merck & Co., Inc., Kenilworth, N.J., U.S.A.

Japan

Taiwan

South Korea

China Germany Austria UK US

Sales

force

January

2019

January

2019

January

2019

November

2018

November

2018

October

2018

November

2018

June 2018 (RCC*1)

August 2018 (HCC*2)

Medical October

2018

October

2018

October

2018

November

2018

October

2018

October

2018

November

2018

January

2019

YoY (Balance

from last

fiscal year)

333% (+7.0B yen)

735% (+0.4B yen)

211% (+0.2B yen)

- (+3.1B yen)

160% (+0.9B yen)

138% (+0.1B yen)

285% (+0.2B yen)

171% (+15.6B yen)

Collaboration has been initiated smoothly in major countries, earlier than original plan Achieved high growth in all countries where collaboration was initiated in FY2018

Both companies’ collaboration demonstrated at international conferences,

such as ASCO*3 and ESMO

*4

At ESMO 2018 MSD booth, clinical results of

LENVIMA was presented utilizing digital panels

At ASCO 2018 Eisai booth, collaboration for LENVIMA with Merck & Co., Inc., Kenilworth, N.J., U.S.A. was exhibited utilizing digital

panels and pipeline of combination therapy of LENVIMA and KEYTRUDA®*5 was also presented

Active collaboration on regional basis

China, Asia and Japan meeting

0

100

Q1 Q2 Q3 Q4 Q12 Q22 Q32 Q42

(Billions of yen)

Collaboration initiated in US

Collaboration initiated in Japan, EU, China

and Asia

Global revenue of LENVIMA

Execution of comprehensive

strategic collaboration

FY2017 FY2018

62.6 B yen of revenue in

FY2018

High growth of 194% YoY

achieved

*1: Renal cell carcinoma *2: Hepatocellular carcinoma *3: American Society of Clinical Oncology annual meeting 2018 *4: European Society for Medical Oncology annual meeting 2018 *5: Combination therapy of LENVIMA and KEYTRUDA® is investigational. Projects for LENVIMA are under joint development with Merck & Co., Inc., Kenilworth, N.J., U.S.A. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A

10.0

Q1 Q2 Q3 Q4

Early establishment of strong collaboration on regional and global basis, effective and smooth initiation of

marketing and medical collaboration and excellent performance were achieved in FY2018

6

Inhibition of FGFR is important for activity as an immuno-modulator*4

LENVIMA’s immunomodulatory effect potentially enhances efficacy of IO treatment

FGFR

IFNγ

MHC*1

Cancer cell

1. Cytotoxic T cell activation by

decreasing rate of tumor

associated macrophage

2. Induction of PD-L1 expression by

re-activation of IFNγ signaling

pathway by inhibiting FGFR

Cytotoxic

T cells

Immune

suppressive

tumor associated

macrophage (TAM)

LENVIMA

LENVIMA Activation

Reinforce Immuno-Oncology (IO) (1)

Immune modulation through LENVIMA

All projects are investigational.

*1: Major histocompatibility complex *2: Interferon-gamma receptor *3: Suppressor of cytokine signaling

*4: American Association for Cancer Research (AACR) annual meeting 2019 Abstract no. 2242

Induction increase

SOCS*3

Activation

IFNγ pathway

Percentage decrease

Inhibit

binding

Anti PD-1 antibody (exert effect during induction of PD-L1)

Combination therapy with KEYTRUDA®

Interim analysis of Phase Ib/II Study*1 (Study 111) targeting 6 cancer types*2

■Renal cell carcinoma

■Melanoma

■Head and neck cancer

■Endometrial carcinoma

■Non-small cell lung cancer

■Urothelial cancer

Complete response in 8 patients

PD-L1 negative

7

All projects are investigational. Projects for LENVIMA are under joint development with Merck & Co., Inc., Kenilworth, N.J., U.S.A. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck

& Co., Inc., Kenilworth, N.J., U.S.A. *1: Renal cell carcinoma (RCC), endometrial carcinoma, head and neck squamous cell carcinoma, urothelial carcinoma, non-small cell lung cancer (NSCLC) and melanoma *2: Presented at the 54th Annual Meeting of the American Society Of Clinical Oncology (ASCO), data cutoff were December 15, 2017 for endometrial carcinoma, and December 1, 2017 for RCC and head and neck squamous cell carcinoma. The most common TRAEs (any grade) for endometrial carcinoma were hypertension, fatigue, diarrhea, hypothyroidism, decreased appetite, nausea and stomatitis, and for head and neck squamous cell carcinoma, were fatigue, hypertension, diarrhea, decreased appetite, oropharyngeal pain and stomatitis. The most common AEs (any grade) for RCC were diarrhea, fatigue, hypothyroidism, stomatitis and nausea. Presented at The Society for Immunotherapy of Cancer's (SITC) 33rd Annual Meeting, data cutoff was March 1, 2018 for NSCLC, melanoma and urothelial carcinoma. The most common TRAEs (any grade) for NSCLC were decreased appetite, fatigue, hypothyroidism, diarrhea, proteinuria, arthralgia and hypertension, for melanoma were fatigue, decreased appetite, diarrhea, hypertension, dysphonia, nausea, arthralgia and proteinuria, and for urothelial cancer were proteinuria, diarrhea, hypertension, fatigue and hypothyroidism

Microsatellite stable

Tu

mo

r d

iam

ete

r ch

an

ge

rate

(%

)


Aim to realize the value for patients by attempting to expand potential of IO (Tumor response was observed regardless of PD-L1 and Microsatellite instability (MSI) status)

8

Hepatocellular carcinoma 1L Phase III initiated in December 2018

LEAP-002

Endometrial carcinoma 1L Phase III initiated in April 2019

LEAP-001

Melanoma 1L Phase III initiated in March 2019

LEAP-003

Melanoma 2L Phase II initiated in January 2019

LEAP-004

NSCLC*2 1L Non-squamous cell carcinoma

Combination with chemotherapy

Phase III initiated in March 2019

LEAP-006

NSCLC 1L PD-L1 positive

Phase III initiated in March 2019

LEAP-007

NSCLC 2L Submitted IND in December 2018

for Phase III

LEAP-008

Head and neck

cancer 1L

Basket trial in

multiple cancer types: Triple-negative breast cancer

Gastric cancer

Ovarian cancer

Colorectal cancer

Glioblastoma

Biliary tract cancers

Phase II initiated in February 2019

LEAP-005

Head and neck

cancer 2L

Urothelial carcinoma 1L Phase III initiated in May 2019

LEAP-011

Endometrial carcinoma 2L Phase III initiated in June 2018

Study 309

Renal cell carcinoma 1L Phase III initiated in October 2016

Study 307

Of the planned 13 studies for the combination therapy with KEYTRUDA®,

11 studies have been initiated/submitted IND*1, and the remaining 2 studies are

planned to be initiated within FY2019

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. 1L: First line 2L: Second line. *1: Investigational New Drug *2: Non-small cell lung cancer *3: LEAP-005 is not included


Plan to conduct a total of 12 pivotal studies*3 concurrently in FY2019

9

Potential Conversion in Treatment From Japan*1

Potential conversion in treatment of unresectable hepatocellular carcinoma (uHCC)

with LENVIMA

Japan has world-class advanced treatment

technique for uHCC. Time from initial diagnosis

to death was longer in Japan compared with

other regions*2 (median, 79.6 months in Japan

vs 14.8–25.0 months in other regions)

As the pioneer in the world, Japan has

developed various standard of therapies for

uHCC such as TACE*3, ethanol injection,

HAIC*4 and MCT*5

Resectable Unresectable

Tumor shrinkage effect of LENVIMA in the real world setting

Tumor

Potential conversion to curative treatment Resection RFA*7

Selective TACE

Potential new treatment concept utilizing LENVIMA

is aiming for the conversion from non-curative to

curative treatment through tumor shrinkage, which

was observed in the real world setting in Japan*6

*1: Reports from real world setting in Japan *2: Kudo M et al: Liver international,36,1196-1205(2016) *3: Transcatheter arterial chemoembolization *4: Hepatic arterial infusion chemotherapy

*5: Microwave coagulation therapy *6: Dr. Masatoshi Kudo, Eisai Media/Investor Conference “Hepatocellular Carcinoma – Latest Trends in Diagnostics and Treatment” on September 18, 2018

*7: Radiofrequency ablation *8: Kudo M: EASL-International Liver Congress Symposium in Japan held on April 13, 2019 *9: Barcelona clinic liver cancer (BCLC) *10: Albumin-bilirubin score

Advanced treatment of uHCC in Japan Potential conversion in treatment of uHCC with

LENVIMA reported from Japan in the real world setting

Real world setting*8

Reference:

REFLECT Study BCLC

*9-B

ALBI*10

grade 1

BCLC-B or C

ALBI grade 1

Objective

response

rate (ORR)

80.9% Further increase

57.1% Increase

40.3%

Potential increase in chance of conversion

implicated through increase of ORR by

administration of LENVIMA at earlier timing of BCLC

Potential in conversion from uHCC to resectable HCC to further improvement of survival time.

Aim for potential innovative conversion of treatment by LENVIMA

10

Ten “Oncology Powerhouses” *1 including Eisai, possess a compound for

potential cancer treatment that has received more than

three Breakthrough Therapy designations*2

(first for Japanese company)

Aim to steadily achieve value maximization and patient contribution that were

aimed at the time of execution of collaboration agreement, through close and

active collaboration from operational to top management level.

A maximum of up to $5.76 billion USD of financial considerations can

potentially be received. $1.38 billion USD has been recognized at the end of

March 2019. In addition, recognition of a one-time $0.2 billion USD option

payment associated with certain option rights, regulatory milestone payment

and multiple sales-based milestone payments are expected in FY2019.

Aim for Higher Leap of LENVIMA

Projects for LENVIMA are under joint development with Merck & Co., Inc., Kenilworth, N.J., U.S.A. KEYTRUDA® is a registered trademark of Merck Sharp &

Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A. *1: Based on internal research: Pfizer, AbbVie/Pharmacyclics, Novartis, Merck, Bristol-Myers Squibb, Loxo Oncology, Janssen, Roche/Genentech, Seattle Genetics *2: LENVIMA has received Breakthrough Therapy designations for following indications: second line renal cell carcinoma (RCC) in combination with everolimus (July 2015), first line RCC in combination with KEYTRUDA® (January 2018) and second line endometrial carcinoma in combination with KEYTRUDA® (July 2018)

11

Oncology Pipeline Focusing on Cancer Genomics

and Next-generation Immuno-Oncology (IO) Therapy

Eribulin liposomal formulation

E7389-LF

Next-generation drug improving tumor microenvironment

E7130*8

FGFR4 inhibitor

H3B-6527

SF3B1 modulator

H3B-8800

STING agonist

E7766

Phase I Phase II Phase III

Farletuzumab-eribulin

antibody-drug conjugate (ADC)

MORAb-202

ER alpha inhibitor

H3B-6545

LENVIMA

Eribulin platform

FGFR1,2,3 inhibitor

E7090

Immuno-modulator

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. 1L: First line, 2L: Second line

*1: Renal cell carcinoma, endometrial carcinoma, hepatocellular carcinoma, non-small cell lung cancer, melanoma and urothelial carcinoma

*2: Triple-negative breast cancer, gastric cancer, ovarian cancer, colorectal cancer, glioblastoma, biliary tract cancer *3: Under preparation for Phase I study

*4: Designation for the treatment of unresectable biliary tract cancer with FGFR2 gene fusion *5: Ministry of Health, Labour and Welfare *6: Phase I / II study ongoing

*7: Under development in collaboration with PRISM BioLab *8: Compound co-created with Harvard University

Cancer driver gene

Splicing platform

Breakthrough therapy designation from FDA

SAKIGAKE designation*4

from JAPAN MHLW*5

Renal cell carcinoma 2L combination with everolimus

Renal cell carcinoma 1L combination with KEYTRUDA®

Endometrial carcinoma 2L combination with KEYTRUDA®

Solid tumors

Solid tumors

Hepatocellular carcinoma

and others

Hematological malignancies

Solid tumors*3

Breast cancer*6

Basket trial*2

Biliary tract cancer and others

Combination therapy with KEYTRUDA® *1

CBP/Beta-catenin inhibitor

E7386*7 Solid tumors

Solid tumors

12

Selectivity of

BAN2401

Monomer Dimer Oligomer Protofibrils Amyloid plaque Fibril

A-beta

A-beta

aggregation

*1: Investigational. Antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic. Co-development with Biogen.

*2: Internal data: IC50 1.8nM *3 van Dyck. Biol Psychiatry. 2018;83:311

*4: mAb158 (the murine analog of BAN2401) data produced as the result of a strategic research alliance between Eisai and BioArctic. *5: PLoS ONE, 2012, 7, e32014

*6: Acta Neuropathol Commun 2013, 1, 60 *7: bioRxiv preprint first posted online Apr. 6, 2019; doi: http://dx.doi.org/10.1101/601492

Aim to Develop Potential World’s First

Disease-Modifying Treatment (DMT) for AD (1)

BAN2401*1

is an antibody, which has strong affinity and selectivity to protofibrils

BAN2401 is an antibody with selectivity to A-beta protofibrils,

developed by amyloid with the Arctic mutation

which produces a high amount of A-beta protofibrils

Characteristics of BAN2401

• Selectivity to aggregated A-beta species and low affinity for A-beta monomers

• Relative affinity to A-beta protofibrils*2,3

• 10 to 15 times more selectivity to A-beta protofibrils over A-beta fibril was observed*4

• A-beta protofibrils are among the most toxic A-beta aggregates*5

and are potentially

associated with neurodegeneration*6,7

Primary endpoint

• Change from baseline in CDR-SB at 18 months

Key secondary endpoints

• Changes from baseline at 18 months in: - Amyloid plaques levels, as measured by

PET - ADCOMS - ADAS-cog14

Biomarker endpoints

• Cerebrospinal fluid (CSF) biomarkers, such as A-beta 1-42, neurogranin, neurofilament light chain, t-tau, p-tau, and other biomarkers

• 1,566 subjects with early Alzheimer’s disease

- Mild cognitive impairment (MCI) due to

Alzheimer's disease or mild Alzheimer's

dementia

- Amyloid pathology confirmed

• Administration method:

10 mg/kg bi-weekly of BAN2401 (No titration)

and placebo in 1:1 ratio

13



Clarity AD: Phase III study (Study 301) of BAN2401*1

*1: Investigational. Antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic. Co-development with Biogen.

*2: The sites which have expertise in AD field, accumulated experience for clinical studies for AD, and capability to enroll right patients

Population Endpoints

Initiated screening for patients who are qualified for the study protocol

after the completion of Quality Sites*2 selection

A single Phase III study is being initiated to support filing for BAN2401

Final readout of Primary endpoint targeted in Q1 FY2022

14

• 26% less decline in progression of disease over placebo was observed with CDR-SB

in Phase II study (Study 201) with 856 subjects and it suggested clinically meaningful

efficacy

• Phase III study (Clarity AD) is designed to show treatment efficacy with statistical

significance to set the number of enrollment to achieve sufficient study power in

CDR-SB as a Primary endpoint

• CDR-SB is widely used as a primary endpoint for Phase III studies in early AD

for its high sensitivity in early stage of AD and is believed to be a clinical

evaluation index to measure both cognitive functions and execution functions

• BAN2401* showed clinically meaningful results of less decline in clinical symptoms in

CDR-SB in Phase II study (Study 201)

• Clarity AD (Phase III study) is designed with the aim to verify clinical efficacy with statistical

significance in CDR-SB

• CDR-SB is widely used in Phase III study as a clinical evaluation index to measure disease

progression



Clarity AD: CDR-SB as a primary endpoint

* Investigational. Antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic. Co-development with Biogen.

15



Elenbecestat*

: Combine MISSION AD1, 2 into a single database

* Investigational. Co-development with Biogen.

Seek possibility of earlier submission with integrated analysis

and aim to increase probability of success with increased study power

Final readout of primary endpoint targeted in Q1 FY2021

• May potentially increase probability of success (sufficient study power) by leveraging

highly powered combined larger trial database

• Potentially enable to shorten the time for preparation of materials for submission by

combining into a single database

Protocol enhancement by combining MISSION AD1 and AD2

into a single database with approx. 2,100 subjects

16

Prevention Restorative

MCI Mild AD Moderate AD Severe AD Preclinical AD High risk

Bio

mark

er

Max.

Min.

Preemptive

A45 A3

Aim to Develop Potential World’s First Disease-Modifying

Treatment (DMT) for AD (5)

Initiative for Wider Scope Strategy

Two AD prevention studies (A3 study and A45 study*1

) planned by

Alzheimer’s Clinical Trials Consortium(ACTC)*2

A3 study A45 study

Ante-Amyloid Prevention in Alzheimer’s Disease Trial, a

primary prevention study aimed at preventing the initial

amyloid build-up in the brain with BACE inhibitor

administration

Individuals who have high risk of AD and are currently

amyloid negative and no cognitive impairment

Elenbecestat*4 (2 dosages)

Brain amyloid (Amyloid PET)

Brain tau pathology (Tau PET)

Clinical evaluation on cognitive function (PACC*6)

Preclinical AD study to mainly evaluate intervention with both anti-A-beta antibodies and BACE inhibitors to prevent cognitive decline

Clinically normal subjects (no/minor cognitive impairment) who have elevated levels of A-beta in brain and are at increased risk for progression to mild cognitive impairment and AD dementia

BAN2401*5,7 and elenbecestat

(Individuals will be treated first with BAN2401 to clear amyloid deposits and A-beta

protofibrils from the brain, after which they will be maintained on elenbecestat with

the aim of decreasing the production of A-beta and preventing the re-accumulation

of amyloid plaques and protofibrils)

Clinical evaluation on cognitive function (PACC) Brain amyloid (Amyloid PET) Brain tau pathology (Tau PET)

Amyloid PET CSF*3 tau Hypometabolism MRI Atrophy Cognitive impairment

Elenbecestat and BAN2401 were selected for prevention studies by ACTC, one of the world’s expert on AD

All projects are investigational. *1: A45 study is a modified A4 study, which evaluates the efficacy of anti-a-beta antibody (Anti-Amyloid Treatment in Asymptomatic Alzheimer’s

Disease Trial) by adding the treatment with BACE inhibitor *2: The ACTC, funded by the National Institute on Aging at the US National Institutes of Health (NIH), provides the

infrastructure for academic clinical trials in Alzheimer’s Disease and related dementias. The ACTC was established in December 2017 and includes 35 primary clinical sites

across the United States *3: Cerebrospinal fluid *4: Co-development with Biogen *5: The details for the study design are under planning *6: Preclinical Alzheimer Cognitive

Composite. *7: Antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic

Target

Agent

Endpoints*5

Target

Agent

Endpoints*5

Regenerative

Clarity AD

MISSION AD

Strengthen Capability to Develop Potential World’s First

Disease-Modifying Treatment (DMT) for AD and

Robust Pipeline Aiming at Wider Scope of Dementia

Discovery Phase I Phase II Phase III

PDE9 inhibitor

E2027 Dementia with Lewy bodies*7

Anti-tau antibody

E2814 Early AD*3

Synapse regenerant

E2511 AD

Synapse modulator

EphA4 Project*9 AD

Submission

Insomnia disorder, including older patients Dual orexin receptor antagonist

Lemborexant

Transformation of symptoms

Synaptic functional modulator with novel MOA

E2730 Epilepsy and other neurological disorders

*8

Next-generation AMPA receptor antagonist

E2082 Epilepsy and other neurological disorders*8

All projects are investigational *1: Irregular sleep-wake rhythm disorder associated with AD/dementia *2: Co-development with Biogen *3: Under preparation for clinical study

*4: The study targets individuals who are not turned brain A-beta positive level yet, but have higher risk to develop AD with further accumulation of brain A-beta and have

clinically normal cognitive function *5: The study targets individuals who are in brain A-beta positive level with high risk to advance disease progression to MCI or AD and

have clinically normal cognitive function, including no cognitive dysfunction at all or slight cognitive dysfunction

*6: Antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic

*7: Phase II/III ongoing *8: including dementia *9: Research at KAN Research Institute

Early AD BACE inhibitor

Elenbecestat*2

Early AD Anti-A-beta protofibrils antibody

BAN2401*2,6

Brain homeostasis

Proteinopathy

ISWRD*1

Preclinical AD*3,4,5

Preclinical AD*3,5

17

Business Model Transformation

Platform IoT

Regional collaboration Apps

Implementation

Data Science

Data Lake

Data Management

Algorithm

Japan, US, China ・・・

Data Driven Drug

Discovery and Development (5D)

Establish Dementia

Ecosystem globally

New Partnership for Data Platform

Collaboration with Allm Inc. and new establishment of a corporate venture investment business

within the framework of 15B yen

・・・

Establish data-driven business model under the 4th Industrial Revolution (4IR)

18

19

FY2018 FY2019

Results % Forecast % YoY

Revenue 642.8 100.0 680.0 100.0 106

Cost of sales 184.5 28.7 180.0 26.5 98

Gross profit 458.3 71.3 500.0 73.5 109

R&D expenses 144.8 22.5 154.5 22.7 107

SG&A expenses 228.2 35.5 245.0 36.0 107

Other income & expenses 0.9 0.1 2.5 0.4 289

Operating profit 86.2 13.4 103.0 15.1 120

Profit for the year 66.5 10.3 72.5 10.7 109 Profit for the year (attributable to owners of the parent) 63.4 9.9 72.0 10.6 114

EPS (yen) 221.3 251.3 114

ROE (%) 10.4 11.2

DOE (%) 7.0 6.7

Dividends per share (yen) 150 150


Forecast for FY2019 (IFRS)

Development of potential disease modifying treatment (DMT) for AD,

Immuno-oncology (IO) and Data Driven Business Model

FY2018 average exchange rates: 1 USD: 110.90 yen, 1 EUR: 128.40 yen, 1 GBP: 145.67 yen, 1 RMB: 16.53 yen

FY2019 average exchange rates (forecast rate): 1 USD: 110 yen, 1 EUR: 125 yen, 1 GBP: 139 yen, 1 RMB: 16 yen

Reference Data

20

FY2017 FY2018


Japan*1 296.2 49.4 301.1 46.8 102

Americas*2 113.9 19.0 97.9 15.2 86

China 56.2 9.4 66.3 10.3 118

EMEA*3 44.3 7.4 49.8 7.7 112

Asia and Latin America*4 42.6 7.1 48.7 7.6 114

Pharmaceutical business

total 553.2 92.2 563.7 87.7 102

Other business*5 46.8 7.8 79.1 12.3 169

Consolidated revenue 600.1 100.0 642.8 100.0 107

Revenue by Reporting Segment


21

*1: Primarily Prescription Medicines, Generics, OTC and others *2: North America *3: Europe, Middle East, Africa, Russia and Oceania

*4: Primarily South Korea, Taiwan, Hong Kong, India, ASEAN, Central and South America *5: “Other business” mainly includes license revenue and the pharmaceutical

ingredient business of the parent company. Recognition of payments from Merck & Co., Inc., Kenilworth, N.J., U.S.A. under the strategic collaboration for anticancer agent

Lenvima were included (34.5 billion yen in FY2017, 65.5 billion yen in FY2018).

Profit by Reporting Segment

FY2017 FY2018

Results % YoY Results % % of

revenue YoY

Japan 104.4 45.5 35.3 104.7 37.2 34.8 100

Americas 43.6 19.0 38.3 46.3 16.5 47.4 106

China 15.5 6.7 27.5 24.4 8.7 36.8 158

EMEA 15.4 6.7 34.9 19.7 7.0 39.7 128

Asia and Latin America 12.4 5.4 29.2 15.3 5.4 31.4 123

Pharmaceutical business

total 191.4 83.4 34.6 210.5 74.8 37.3 110

Other business 38.0 16.6 81.2 70.8 25.2 89.5 186

Reporting segment total 229.4 100.0 38.2 281.4 100.0 43.8 123

R&D expenses and

group headquarters’

management costs and

other expenses*

(152.2) (195.2)

Consolidated operating

profit 77.2 12.9 86.2 13.4 112

22


* Includes the amount of profits and expenses shared with partners under strategic collaborations and the amount of shared profit for anticancer agent Lenvima paid by

Eisai to Merck & Co., Inc., Kenilworth, N.J., U.S.A. (23.9 billion yen in FY2018).

Revenue of Major Products

FY2017 FY2018


Lenvima 32.2 100.0 62.6 100.0 194 [195]

Japan 3.0 9.3 10.0 15.9 333 [333]

Americas 21.9 68.0 37.5 60.0 171 [171]

China 3.1 5.0

EMEA 5.8 18.1 8.0 12.8 137 [140]

Asia and Latin America 1.5 4.6 4.0 6.4 268 [273]

23

Halaven 39.9 100.0 41.3 100.0 104 [105]

Japan 9.3 23.2 9.4 22.8 102 [102]

Americas 15.7 39.4 16.4 39.8 105 [105]

EMEA 12.1 30.4 12.7 30.7 105 [107]

Asia and Latin Americas 2.8 7.0 2.7 6.6 99 [102]

Fycompa 14.7 100.0 19.3 100.0 132 [132]

Japan 1.7 11.7 3.0 15.3 172 [172]

America 6.9 47.1 9.3 48.2 135 [135]

EMEA 5.4 36.8 6.1 31.8 114 [116]

Asia and Latin America 0.6 4.4 0.9 4.6 139 [141]


[ ] based on local currency

FY2017 FY2018


Revenue 296.2 100.0 301.1 100.0 102

Prescription medicines 246.7 83.3 251.6 83.6 102

Humira 43.4 14.6 46.9 15.6 108

Lyrica*1 26.5 9.0 28.3 9.4 107

Aricept 24.4 8.2 17.9 6.0 74

Methycobal 17.2 5.8 15.0 5.0 87

Pariet*2,3 17.2 5.8 12.9 4.3 75

Lunesta 10.2 3.4 11.2 3.7 110

Lenvima 3.0 1.0 10.0 3.3 333

Halaven 9.3 3.1 9.4 3.1 102

Treakisym 6.9 2.3 7.2 2.4 105

Elental*2 6.6 2.2 6.4 2.1 97

Warfarin 6.0 2.0 5.4 1.8 90

Livact*2 5.9 2.0 4.8 1.6 81

Fycompa 1.7 0.6 3.0 1.0 172

Generics 27.8 9.4 25.2 8.4 90

Consumer healthcare business 21.7 7.3 24.3 8.1 112

Segment profit 104.4 35.3 104.7 34.8 100

24

Performance of

Japan Pharmaceutical Business


*1: Alliance revenue *2: EA Pharma product

*3: Includes sales of triple formulation Helicobacter pylori eradication packs, Rabecure Pack 400/800 and Rabefine Pack

FY2017 FY2018


Revenue 113.9 100.0 97.9 100.0 86 [86]

Lenvima 21.9 19.2 37.5 38.3 171 [171]

Banzel 16.6 14.5 17.5 17.9 106 [106]

Halaven 15.7 13.8 16.4 16.8 105 [105]

Fycompa 6.9 6.1 9.3 9.5 135 [135]

AcipHex 6.0 5.3 4.8 4.9 80 [80]

BELVIQ 3.6 3.1 3.9 4.0 110 [110]

Aloxi 39.6 34.7 1.7 1.8 4 [4]

Segment profit 43.6 38.3 46.3 47.4 106 [106]

25



Performance of

Americas Pharmaceutical Business

FY2017 FY2018


Revenue 56.2 100.0 66.3 100.0 118 [119]

Methycobal 18.8 33.4 20.0 30.1 106 [108]

Stronger Neo-Minophagen C and

Glycyron Tablets 10.2 18.1 10.7 16.2 105 [107]

Aricept 7.5 13.4 9.3 14.1 124 [126]

Pariet 4.5 8.0 5.7 8.7 128 [130]

Lenvima 3.1 4.7

Segment profit 15.5 27.5 24.4 36.8 158 [160]

26

Performance of

China Pharmaceutical Business



FY2017 FY2018


Revenue 44.3 100.0 49.8 100.0 112 [114]

Halaven 12.1 27.3 12.7 25.5 105 [107]

Lenvima / Kisplyx 5.8 13.1 8.0 16.0 137 [140]

Fycompa 5.4 12.2 6.1 12.3 114 [116]

Zebinix 4.9 11.0 5.8 11.6 118 [119]

Zonegran 4.4 9.9 4.1 8.2 93 [95]

Inovelon 2.3 5.1 2.4 4.7 104 [106]

Segment profit 15.4 34.9 19.7 39.7 128 [130]

27



Performance of

EMEA Pharmaceutical Business

FY2017 FY2018


Revenue 42.6 100.0 48.7 100.0 114 [116]

Humira 11.6 27.1 13.0 26.7 112 [113]

Aricept 11.2 26.4 11.8 24.2 105 [106]

Lenvima 1.5 3.5 4.0 8.2 268 [273]

Pariet 3.9 9.1 3.9 8.0 101 [102]

Methycobal 3.1 7.2 3.2 6.5 103 [105]

Halaven 2.8 6.5 2.7 5.6 99 [102]

Fycompa 0.6 1.5 0.9 1.8 139 [141]

Segment profit 12.4 29.2 15.3 31.4 123 [122]

28



Performance of Asia and Latin America

Pharmaceutical Business

85.1

43.0

FY2018 Free cash flow FY2018 dividend payment

FY2018

Net cash from

operating activities 103.7

Capital expenditures -18.7

Free cash flow 85.1

29

Enable investment

for future growth and

stable dividend

Net cash position

sustained as a principle Generated free cash flow to exceed

dividend payment*3

End of FY2018 Change from

end of FY2017

Interest-bearing debt 138.9 -34.2

Cash and securities 339.1 +8.6

Net cash*1

200.2 +42.9

Net DER*2 -0.32 -0.05

Equity attributable to

owners of the parent 628.1 +34.5

Ratio of equity attributable

to owners of the parent 58.6% +2.0%

Balance Sheet Cash Flow

*3

Strong Balance Sheet & Ample Cash Flow

to Support Investment in Future Growth and

Stable Dividend

(Billions of yen) (Billions of yen)

(Billions of yen)

*1: Net cash = Cash and securities (cash and cash equivalents + time deposits exceeding 3 months + parent company holding investment securities) – interest-bearing

debt (corporate bonds and loans) *2: Net Debt Equity Ratio (Net DER) = (Interest bearing debt (corporate bonds and loans) – cash and cash equivalents – time deposits

exceeding 3 months – parent company holding investment securities) / equity attributable to owners of the parent company

*3: Dividend per share subject to resolution of Board of Directors

Overview of BACE Inhibitor

Clinical Trial Designs

Study designs for Phase II and beyond in the chart above was created by Eisai based on the information on ClinicalTrials.gov as of January 7, 2019. All projects are investigational. *1: Merck announced discontinuation of APECS study on February 13, 2018 on their news release *2: Merck announced discontinuation of EPOCH study on February 14, 2017 on their news release *3: 60mg dose is only in Part I of study *4: Eli Lily and AstraZeneca announced discontinuation of AMARANTH and DAYBREAK-ALZ study on June 12, 2018 on their news releases *5: Janssen announced discontinuation of EARLY study on May 17, 2018 on their news release *6: Target population for this study is participants who are asymptomatic at risk for developing AD *7: Janssen announced their decision to stop dosing of patients in the atabecestat arm of the DIAN-TU study on July 18, 2018 on their news release *8: Target population for this trial is individuals at risk for or with a type of early onset Alzheimer's disease caused by a genetic mutation *9: CAD106 is active a-beta immunotherapy *10: Target population for this trial is people at the risk to develop clinical symptoms based on their age and genotype *11: Target population for this trial is people at risk for the onset of clinical symptoms of AD based on their age, ApoE genotype and elevated amyloid

Drug (Sponsor) Study name

(Stage)

Target population

(Estimated

Enrollment) Dosage Inclusion criteria (partial)

Efficacy measures

(Primary endpoints)

Elenbecestat

(Eisai, Biogen)

MISSION AD1 Early AD

50mg

Placebo

MMSE: ≧24, CDR: 0.5

CDR memory box ≧0.5,

Amyloid positive

CDR-SB

(24 months)

(Phase III) (1330)

MISSION AD2 Early AD

(Phase III) (1330)

Verubecestat (Merck Sharp & Dohme

Corp.)

APECS*1

(Phase III)

Prodromal AD

(1454)

12mg Diagnosis of prodromal AD (history of subjective memory

decline, does not meet criteria for dementia, Amyloid-beta

positive)

CDR-SB

(104 weeks) 40mg

Placebo

EPOCH*2

(Phase II/III)

Mild to moderate

AD (2211)

12mg Diagnosis of probable AD based on both NINCDS-ADRDA

criteria and DSM-IV-TR criteria for AD,

AD is of mild to moderate severity

ADAS-cog

(78 weeks)

ADCS-ADL

(78 weeks)

40mg

60mg*3

Placebo

Lanabecestat

(Eli Lilly)

AMARANTH*4

(Phase II/III) Early AD (7255)

20mg MMSE≧20, MCI due to AD,

Probable AD (NIA-AA)

ADAS-cog13

(104 week) 50mg

Placebo

DAYBREAK-ALZ*4

(Phase III)

Mild AD

(5697)

Lanabecestat

Placebo

MMSE: 20- 26, CDR: 0.5 or 1 and CDR memory box ≧0.5,

Probable AD dementia (NIA-AA)

ADAS-cog13

(78 weeks)

Atabecestat (Janssen Research &

Development, LLC)

EARLY*5

(Phase II/III)

Preclinical AD*6

(1650)

5mg

25mg

Placebo

CDR: 0, Amyloid-beta positive

(Participants 60-64 years age must also have 1 of PACC

(54 months) the following conditions; positive family history of dementia,

APOE ɛ4 genotype, or elevated amyloid accumulation)

Atabecestat (Washington University

School of Medicine)

DIAN-TU*7 (Phase II/III)

Preclinical AD*8

(438) 25mg

Placebo

Have an Alzheimer's disease-causing mutation or are unaware of their genetic status and have a 50% chance of

having ADAD mutation, cognitively normal or with mild cognitive impairment or mild dementia, CDR: 0-1

DIAN-TU cognitive composite score

(52, 104, 156, 208 weeks)

CNP520, CAD106*9 Generation S1 Preclinical AD*10 50mg MMSE≧24 Time to MCI due to

AD or dementia due

to AD, APCC

(60 months)

(Phase II/III) (1340) Placebo Homozygous APOE4 genotype

CNP-520

(Novartis)

Generation S2

(Phase II/III)

Preclinical AD*11

(2000)

15mg

50mg Placebo

Carrier of at least one APOE4 gene if Heterozygotes,

elevated brain amyloid (as measured by CSF A-beta or

amyloid PET imaging)

30

Overview of Anti-A-beta Antibody

Clinical Trial Designs

Drug

(Sponsor)

Study name

(Stage)

Target population

(Estimated enrollment) Dose

Inclusion criteria

(partial)

Efficacy measurement

(Primary endpoints)

BAN2401*1

(Eisai, Biogen) Clarity AD (Phase III)

Early AD

(1566) 10mg/kg biweekly

Placebo

MCI due to AD, mild AD (NIA-AA),

CDR: 0.5, CDR memory box ≧0.5,

Amyloid positive, MMSE≧22,

WMS-IV LMII: 1 SD below age-adjusted mean

CDR-SB

(18 months)

Aducanumab

(Biogen, Eisai)

ENGAGE (Phase III)*2 Early AD (1605) Low dose

High dose

Placebo

MCI due to AD or mild AD

CDR-Global Score: 0.5

MMSE≧24, Amyloid positive

CDR-SB

(78 weeks) EMERGE (Phase III)*2 Early AD (1605)

Gantenerumab

(Roche)

SCarlet RoAD*3,4

(Phase III)

Prodromal AD

(799)

105mg,

225mg,

Up to 1200mg

Placebo

MMSE≧24, Prodromal AD who are not receiving

memantine or cholinesterase inhibitors

CDR-SB

(104 weeks)

Marguerite RoAD*4

(Phase III) Mild AD (389)

Gantenerumab

Placebo

Clinical diagnosis of probable mild AD

(NINCDS/ADRDA), Amyloid-beta positive in CSF

ADAS-Cog13 (104 weeks),

ADCS-ADL (104 weeks)

Graduate I (Phase III) Early AD (760) Probable AD dementia or prodromal AD (NIA-AA),

Amyloid positive, MMSE≧22,

CDR-GS: 0.5 or 1.0

CDR-SB

(104 weeks) Graduate II (Phase III) Early AD (760)

Crenezumab

(Roche)

CREAD 1*5 (Phase III) Prodromal to mild AD

(813) Crenezumab

Placebo

MCI due to AD,

Probable AD dementia (NIA-AA), MMSE≧22,

CDR-GS 0.5 or 1.0, A-beta positive

CDR-SB

(105 weeks) CREAD 2*5 (Phase III) Prodromal to mild AD

(750)

Solanezumab

(Eli Lilly)

EXPEDITION3*6

(Phase III) Mild AD (2129) 400mg

Placebo

Probable AD (NINCDS/ADRDA)

Modified Hachinski Ischemia Scale≦4, MMSE: 20-26,

Geriatric Depression Scale≦6, Amyloid-beta positive

ADAS-Cog14

(80 weeks)

EXPEDITION PRO*7

(Phase III) Prodromal AD (26) Solanezumab

Placebo

Probable AD (IWG), MCI due to AD (NIA-AA), MoCA:

17-28, FCSRT (Picture version)<27,

Modified Hachinski Ischemia Scale: ≤4, FAQ>0,

Amyloid-beta positive

ADAS-Cog14

(24 months)

A4 (Phase III) Preclinical AD*8 (1150) Solanezumab

Placebo

MMSE≧25, CDR: 0, Logical Memory II score 6-18,

Amyloid positive

PACC

(240 weeks, 366 weeks)

Gantenerumab,

Solanezumab (Washington University

School of Medicine)

DIAN-TU (Phase II/III) Preclinical AD*9 (490) Gatenerumab

Solanezumab

Placebo

Have an Alzheimer's disease-causing mutation or are

unaware of their genetic status and have a 50%

chance of having ADAD mutation, Cognitively normal

or with mild cognitive impairment or mild dementia,

CDR: 0-1

DIAN-TU cognitive

composite score (52, 104,

156, and 208 weeks)

Study designs for Phase II and beyond in the chart above was created by Eisai based on the information on ClinicalTrials.gov as January 7, 2019. All projects are investigational. *1: Eisai licensed in from BioArctic. Eisai announced the initiation of open-label extension (OLE) study at FY2018 Q2 Earnings Presentation on November 1, 2018. *2: Biogen and Eisai announced discontinuation of ENGAGE and EMERGE study on March 21, 2019 on the news release *3: Roche announced discontinuation of SCarlet RoAD study on December 19, 2014 on their press release *4: FPI in OLE study was announced at Roche Nine Months 2016 Sales Conference Call on October 20, 2016 *5: Roche announced discontinuation of CREAD 1 and CREAD 2 study on January 30, 2019 on their press release *6:Eli Lilly announced that solanezumab did not meet the primary endpoint in EXPEDITION3 study on November 23, 2016 on their press release *7: Eli Lilly announced discontinuation of EXPEDITION-PRO study on January 31, 2017 at 2016 Q4 Earnings call *8: Target population for this trial is older individuals who may be at risk for memory loss *9: Target population for this trial is individuals at risk for or with a type of early onset Alzheimer's disease caused by a genetic mutation 31

Major A-beta Related AD Projects

Targeting the Progression of the Disease Stages

Solanezumab (LY2062430) Phase III (EXPEDITION3)*12

Crenezumab Phase III (CREAD 1)*11

Verubecestat Phase III (APECS)*3

Verubecestat Phase II/III (EPOCH)*4

Lanabecestat Phase II/III (AMARANTH*5)

Gantenerumab Phase III (SCarlet RoAD)*9,10

Elenbecestat*1

Phase III (MISSION AD1, AD2)

Gantenerumab Phase III (Marguerite RoAD)*10

Lanabecestat Phase III (DAYBREAK-ALZ*5)

Aducanumab*1, 7 Phase III (ENGAGE, EMERGE)

BAN2401*1, 6

Phase III (Clarity AD)

Atabecestat Phase II/III (EARLY)*2

BACE inhibitor

Anti-A-beta antibody

Solanezumab Phase III (A4)

Crenezumab Phase III (CREAD 2)*11

Preclinical AD Prodromal AD Mild AD

Moderate AD Severe AD

Gantenerumab, Solanezumab Phase II/III (DIAN-TU)

Early AD

CNP520, CAD106

Phase II/III (GENERATION S1)

CNP520 Phase II/III (GENERATION S2)

Gantenerumab Phase III (Graduate I&II)

Atabecestat Phase II/III (DIAN-TU)*8

Solanezumab (LY2062430) Phase III (EXPEDITION-PRO)*13

Study design for Phase II and beyond in the chart above is created by Eisai based on the information on ClinicalTrials.gov as of January 7, 2019. All projects are investigational. *1: Co-development with Biogen *2: Janssen announced discontinuation of EARLY study on May 17, 2018 on their news release *3: Merck announced discontinuation of APECS study on February 13, 2018 on their news release *4: Merck announced discontinuation of EPOCH study on February 14, 2017 on their news release *5: Eli Lily and AstraZeneca announced discontinuation of AMARANTH and DAYBREAK-ALZ study on of June 12, 2018 on their news releases *6: Licensed in from BioArctic. Eisai announced the initiation of open label extension (OLE) study at FY2018 Q2 Earnings Presentation on November 1 2018. *7: Biogen and Eisai announced discontinuation of ENGAGE and EMERGE study on March 21, 2019 on the news release *8: Janssen announced their decision to stop dosing of patients in the atabecestat arm of the DIAN-TU trial on July 18, 2018 on their news release *9: Roche announced discontinuation of SCarlet RoAD study on December 19, 2014 on their press release *10: Roche announced FPI in OLE study at Roche Nine Months 2016 Sales Conference Call on October 20, 2016 *11: Roche announced discontinuation of CREAD 1 and CREAD 2 study on January 30, 2019 on their press release *12: Eli Lilly announced that solanezumab did not meet the primary endpoint in the EXPEDITION3 study on November 23, 2016 on their press release. *13: Eli Lilly announced discontinuation of EXPEDITION-PRO study at 2016 Q4 earnings call on January 31, 2017

A-beta vaccine

Combination Study

32

Total 600 million USD (65.5 billion yen) in FY2018

200 million USD (22.0 billion yen*) +

recognition of milestone payments and others

Recognition of multiple

sales-based milestone

payments and

regulatory milestone

payment are expected

33

Milestone payment associated with

the reimbursement approval in EU

25 million USD

(2.8 billion yen)

Q2-3 FY2018 results FY2019 forecast

One-time option payment associated with certain

option rights 325 million USD (35.0 billion yen)

Sales-based milestone payment

anticipated when annual revenue

of 500 million USD is achieved

50 million USD

(5.5 billion yen)


the approvals of hepatocellular

carcinoma indication in the U.S.

125 million USD

(13.9 billion yen)



carcinoma indication in EU

50 million USD

(5.5 billion yen)



carcinoma indication in China

25 million USD

(2.8 billion yen)

Q4 FY2018 results

One-time option payment associated with certain

option rights 200 million USD (22.0 billion yen*)

*Calculation based on 1 USD=110 yen

Recognition of Payments from

Merck & Co., Inc., Kenilworth, N.J., U.S.A.

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