Q2 FY2022(Fiscal Year Ending March 31, 2023)

Financial Results Presentation

Eisai Co., Ltd.
November 7, 2022

Q2 FY2022 Consolidated Statement of Income (IFRS)Steady growth of organic business and continuous investment toward future growth(Billions of yen, %)Revenue

Pharmaceutical Business
Other business

Cost of sales
Gross profit
R&D expenses

R&D expenses including partners reimbursement

SG&A expenses

Expenses regarding shared profit of Lenvima paid to Merck
SG&A expenses excluding the expenses regarding
shared profit of Lenvima paid to Merck

Other income & expenses
Operating profit
Profit for the period
Profit for the period (Attributable to owners of the parent)

April-September FY2021
Results
%

362.4
299.4
62.9
79.9
282.5
79.9
115.1
154.7
41.4
113.3
12.8
60.7
46.4
46.0

100.0
82.6
17.4
22.0
78.0
22.1
31.8
42.7
11.4
31.3
3.5
16.8
12.8
12.7

End of March 2022
Net DER*2 (times)
Ratio of equity attributable to owners of the parent (%)(0.32)
60.4

April-September FY2022
Results
%
YoY

358.6
352.6
6.1
92.5
266.1
81.5
113.5
180.4
61.0
119.4
1.1
5.3
31.8*130.5*1

100.0
98.3
1.7
25.8
74.2
22.7
31.7
50.3
17.0
33.3
0.3
1.5
8.9
8.5

Amount offorex impact

99
118
10
116
94
102
99
117
147
105
8
9
69
66

35.0
34.4
29.6
14.3
24.8
13.8
(9.1)

End of September 2022

(0.24)
65.7

The figures for FY2021 have been revised for retroactive application due to changes in accounting policies.
Q2 FY2022 average exchange rates: 1 USD: 133.97 yen (+22.0% YoY), 1 EUR: 138.72 yen (+6.0% YoY), 1 GBP: 162.88 yen (+6.8% YoY), 1 RMB: 19.88 yen (+17.0% YoY)
*1: Including the impact of repayment of paid-in capital from a consolidated U.S. subsidiary to the Company *2: "Net debt equity ratio (Net DER)" = ("Interest-bearing debt" ("Borrowings") - "Cash and cash equivalents" -"Time deposits
exceeding three months, etc." - "Investment securities held by the parent") / "Equity attributable to owners of the parent"1Revenue of 4 Global Brands

Growth driven by Lenvima and Dayvigo
4 Global Brands

LenvimaAchieved double-digit growth in 4 regions

Halaven
Maintained comparable revenue
level from previous fiscal year

128.2Byen
1,282 億円
(140%
YoY)
（140%）
1,200
120
1,000
100

918 億円
91.8B
yen

200
20

80
800
600
60

19.9B
yen
199 億円

214 億円
21.4B
yen（107%）
(107%
YoY)

100
10

400
40

4 Global Brands total

1,500
150

200
20

00

2021年度April-September
4月-9月
FY20212022年度April-September
4月-9月
FY2022Fycompa
Steadily growth in all regions
200
20
150
15

152
億円
15.2B
yen

201
20.1B億円
yen（133%）
(133%
YoY)

00

2022年度April-September
4月-9月
FY2022

DayvigoAchieved dramatic growth mainly
in Japan136
13.6B億円
yen（214%）(214% YoY)

200
20

100
10

100
10

2021年度April-September
4月-9月
FY20212021年度April-September
4月-9月
FY20212022年度April-September
4月-9月
FY202200

133.2B yen
1,332
億円

1,000
100

500
50

63 億円
6.3B
yen

50
5

00

1,833
183.3B 億円
yen
(138%
YoY)
（138%）

2,000
200

00

2021年度April-September
4月-9月
FY20212022年度April-September
4月-9月
FY2022

2021年度April-September
4月-9月
FY20212022年度April-September
4月-9月
FY2022

2

Segment Information of Pharmaceutical Business

Both revenue and segment profit grew steadily with revenue increase in all regions
Revenue and profit of Pharmaceutical Business
Revenue ofpharmaceutical business
2,994
299.4B億円
yen352.6Byen
3,526 億円
(118%
YoY)
（118%）

Japan
104.0B億円
yen
1,040
100
1,000

2,000
200

Revenue by segments
1,106
億円
110.6Byen（106%）(106%
YoY)

2021年度April-September
4月-9月
FY20212022年度April-September
4月-9月
FY2022

Segment profit ofpharmaceutical business
134.7B億円
yen
1,347

1,730
173.0B億円
yen（128％）
(128%
YoY)

00

2021年度April-September
4月-9月
FY20212022年度April-September
4月-9月
FY2022

China
600
60

1,000
100

53.3B億円
yen
553

63.3B
yen
633 億円（115%）
(115%
YoY)

400
40

00

2021年度April-September
4月-9月
FY2021

Ratio of revenue
by segments*1 (%)

日本
Japan

OTC
and others
一般用医薬品等

アメリカス
Americas

EMEA
EMEA

China
中国

Asia/Latin
America
ｱｼﾞｱ･ラテンアメリカ

April- 34.7
September
FY2021

18.5

25.2

4.1

31.4
AprilSeptember
9.9 FY2022
17.9

30.2

2021年度April-September
4月-9月
FY20212022年度April-September
FY20224月-9月

246
24.6B億円
yen

248 億円
24.8B
yen（101%）(101% YoY)

2021年度April-September
FY2021
4月-9月

2022年度April-September
FY2022
4月-9月

200
20

3.6

00

2021年度April-September
4月-9月
FY20212022年度April-September
4月-9月
FY2022EMEA*3400
10000

28.0B億円
yen
280

350
億円
35.0B
yen
(125% YoY)
（125%）

2021年度April-September
4月-9月
FY20212022年度April-September
4月-9月
FY2022

OTC and others
12.6B
yen
126 億円
12.1B億円
yen
121
(104%
YoY)
（104%）

Asia/Latin America*4

7.0

8.2

9.4

00

0
0

50
200

200
20

2022年度April-September
4月-9月
FY2022754
75.4B億円
yen

106.4Byen
1,064 億円
(141%
YoY)
（141%）

500
50

500
50

00

1,000
100

Americas*2

100
10

0
0

*1: Composition ratio of Pharmaceutical Business, which does not include revenue of Other business *2: North America *3: Europe, the Middle-East, Africa, Russia and Oceania*4: Primarily South Korea, Taiwan, India, ASEAN, Central and South America

2021年度April-September
4月-9月
FY20212022年度April-September
4月-9月
FY2022

3

Upward Revision of FY2022 Consolidated Financial Forecast (IFRS)

Combining increased revenues and profits with continued investment in future growth,ushering in the era of Lecanemab(Billions of yen, %)Revenue
Other business revenue
Cost of sales

Gross profit
R&D expenses
SG&A expenses
Other income & expenses

Operating profit
Profit for the year
Profit for the year

(Attributable to owners of the parent)

EPS (yen)
ROE (%)DOE (%)
Dividend (yen)FY2021Results
%
756.2
100.0
139.0
18.4
174.8
23.1
581.4
76.9
171.7
22.7
366.4
48.5
10.5
1.4
53.7
7.1
45.7
6.0
48.0
167.27
6.6
6.3
160

6.3

Forecast
760.0
53.0

FY2022
%
100.0
7.0

184.0
576.0
166.5
361.5
7.0
55.0
58.0*

24.2
75.8
21.9
47.6
0.9
7.2
7.6

100
38
105
99
97
99
67
102
127

57.0*

7.5

119

YoY

197.80
7.2*
5.8
160

Interim dividend of 80 yen was resolved at the Board of Directors meeting held today, November 7
FY2021 average exchange rates:
1 USD: 112.37 yen, 1 EUR: 130.56 yen, 1 GBP: 153.55 yen, 1 RMB: 17.51 yen
FY2022 Q1-Q2 average exchange rates:
1 USD: 133.97 yen, 1 EUR: 138.72 yen, 1 GBP: 162.88 yen, 1 RMB: 19.88 yen
FY2022 Q3-Q4 expected average exchange rates:
1 USD: 143.00 yen, 1 EUR: 142.00 yen, 1 GBP: 162.00 yen, 1 RMB: 20.40 yen
The figures for FY2021 have been revised for retroactive application due to changes in accounting policies. * Including the impact of repayment of paid-in capital from a U.S. subsidiary to the Company

4Overview of Alzheimer’s Disease (AD)•AD is a progressive and fatal neurodegenerative disease
which accounts for approximately 70%*1 of elderly people living with dementia•

AD begins with slow cognitive and functional deterioration andthen eventually leads to total loss of independence in the later stage•

AD progresses from an asymptomatic preclinical stage to mild cognitive
impairment (MCI), to dementia, and ultimately to death•

AD is the 6th leading cause of death in the U.S.*2•

Pathophysiologically, amyloid plaques, neurofibrillary tangles, neural/synaptic
degeneration, neuro-inflammation are confirmed in AD•

1 out of 3 people diagnosed with MCI progress to AD within 5 years*3•

1 out of 2 people diagnosed with AD initially have mild AD*4•

AD poses a significant economic burden on healthcare system,
people living with AD and their families*1: Alzheimer’s Association. 2022 Alzheimer’s Disease Facts and Figures. Alzheimers Dement 2022;18.
*2: Sherry L. et al., Mortality in the United States, 2020, NCHS Data Brief No. 427, December 2021 (Statistics of 2019)*3: Ward A, et al., Rate of conversion from prodromal Alzheimer’s disease to Alzheimer’s dementia: A systematic review of the literature, Dement Geriatr Cogn Disord Extra 2013 Sep 28;3(1):320-332*4: Yuan J et al., Severity Distribution of Alzheimer's Disease Dementia and Mild Cognitive Impairment in the Framingham Heart Study, Journal of Alzheimer’s Disease, 79, no. 2, pp 807–817, 2021

5

Lecanemab*1

Status after Clarity AD topline results*2

Initiated communication with FDA*3, PMDA*4, EMA*5,and CMS*6•

Aim to achieve regulatory submission for full approval in the U.S. and regulatory submissions in Japan and EU in FY2022
Aim to secure full reimbursement coverage in the U.S.

Review of Biologics License Application (BLA) in the U.S. under accelerated approval (AA) pathway is on track•

With priority review designation, PDUFA*7 action date (targeted review completion date) has been set for January 6, 2023

Preparing to submit for timely publication of Clarity AD results in a peer-reviewed journal with high impact factor•

Written by 12 eminent experts in the field of dementia and 7 experts from Eisai

Lecanemab session at CTAD*8 (November 29, 16:50 - 18:05 PST)
Chairperson: Takeshi Iwatsubo, University of Tokyo – Tokyo, Japan
Presentation 1: Clarity AD: Clinical Trial Background and Study Design Overview
Presentation 2: Lecanemab for the Treatment of Early Alzheimer’s Disease: Topline Efficacy Results from Clarity AD
Presentation 3: Safety Profile of Lecanemab in Early Alzheimer’s Disease
Presentation 4: Imaging, Plasma, and CSF Biomarkers Assessments from Clarity AD

Michael Irizarry

Eisai Inc. Nutley, NJ, U.S.

Christopher van Dyck
Yale School of Medicine - New Haven, CT, U.S.

Marwan Sabbagh

Barrow Neurological Institute - Phoenix, AZ, U.S.

Randall Bateman

Washington University - St. Louis, MO, U.S.

Sharon Cohen

Presentation 5: Context of Clarity AD Results

Toronto Memory Program - Toronto, Ontario, Canada

Panel Discussion and Q&A

Steadily progressing toward securing transparency of data
*1: Investigational antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic. Collaboration with Biogen. *2: Phase III study for lecanemab targeting early Alzheimer’s disease*3: The U.S. Food and Drug Administration *4: Pharmaceuticals and Medical Devices Agency (Japan) *5: European Medicines Agency *6: The Centers for Medicare & Medicaid Services *7: Prescription Drugs User Fee Act*8: The 15th Clinical Trials on Alzheimer's Disease (CTAD), November 29 - December 2, 2022, San Francisco, U.S.

6

Origin and Characteristics of Lecanemab*1

Amyloid precursor protein (APP)

1992

John A. Hardy et al. published“The Amyloid Cascade Hypothesis” in Science*2

Epitope location: 3 - 7

1Aducanumab
3

Epitope location:
p3 - 7 of Aβ with
N-terminal*6
Donanemab pyroglutamylation
7

2001

Arctic mutation*3 on amyloid precursor protein (APP)
increases Aβ protofibril formation*4

11

Aβ

2005

Based on Arctic mutation, initiateddevelopment of an anti-Aβ protofibril antibody*5

Gantenerumab

13
16

18

Epitope location:2 - 11,18 - 27

Lecanemab

20

Arctic mutation
25

Mutation in
22 of Aβ

27

34

2007

Lecanemab was developed as the only Aβ protofibril
antibody with high selectivity and affinity for protofibrils*1: Investigational antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai
and BioArctic. Collaboration with Biogen *2: John A. Hardy and Gerald A. Higgins, Alzheimer’s Disease: The Amyloid
Cascade Hypothesis, Science 10 Apr 1992, Vol 256, Issue 5054, pp.184-185 *3: Arctic mutation: Lars Lannfelt et al.,The ‘Arctic’ APP mutation (E693G) causes Alzheimer’s disease by enhanced Aβprotofibril formation, Nature
Neuroscience, 4, 887-893 (2001)*4: Aβ protofibrils are soluble Aβ aggregates and have high neurotoxicity. Sehlin D. et al., Large Aggregates Are the Major
Soluble Ab Species in AD Brain Fractionated with Density Gradient Ultracentrifugation, PLoS ONE, February 15, 2012
*5: Mouse antibody mAb158 was developed by BioArctic. Eisai and BioArctic have initiated co-development since 2005
*6: N-pyroglutamylation: Cyclization of the N-terminal glutamic acid residue*7: Yamauchi E. et al., Analysis of interaction characteristics between amyloid β and lecanemab by HDX-MS, AAIC2022

When Aβ is in the monomer state, lecanemab recognizes 1 to 16 of Aβ
as epitope location, but when Aβ aggregates and forms protofibrils, theepitope location expands (20 to 34 of Aβ is also recognized)*7. As aresult, protofibrils are more easily recognized, leading to high selectivity
Steven S. Plotkin et al. : Neurobiology of Disease 144 (2020), Passive immunotherapies targeting Aβ and tau in Alzheimer's disease
Farzaneh Modarresi et al. : International Journal of Alzheimer’s Disease（2011）: Knockdown of BACE1-AS Nonprotein-Coding
Transcript Modulates Beta-Amyloid-Related Hippocampal Neurogenesis

7Lecanemab*1

4Rs (Four “right” elements) toward Success in Clarity AD*2

Right hypothesis

Right population

Aβ protofibril

Early AD*3

Right dosage

Right endpoint

10mg/kg bi-weekly
No titration

CDR-SB*4*1: Investigational antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic. Collaboration with Biogen.
*2: Phase III study for lecanemab targeting early Alzheimer’s disease *3: Mild Cognitive Impairment due to AD or mild AD with confirmed amyloid pathology *4: Clinical Dementia Rating Sum of Boxes

8

A Human Biology-Based Approach from Research of Familial AD
to the Discovery of Drugs for the Treatment of Sporadic Alzheimer's Disease (sAD)Discovery of lecanemab*1•

It was discovered that arctic mutation on APP*2, a familial mutation, increases Aβ protofibrils in brain*3 and protofibril expresses
high neurotoxicity*4
•
•

•

•
•

Identification of the disease-generated genes of familial AD and understanding of the pathophysiological changes caused by the disease-causing
genes through functional genetics

Pursue treatment opportunity through removal of Aβ protofibrils in brain
Development of anti-Aβ protofibril antibody with high selectivity

Pursue treatment opportunity for sAD, since high expression level of protofibril is shown in the brain of those with sAD
Verification of efficacy in sAD which has identical pathophysiological characteristics to fAD

Discovery of E2814*5 (anti-tau antibody)

Analysis of CSF*6 from mutation carriers with dominantly inherited AD (DIAD)*7 showed that CSF MTBR*8-tau was specificallyincreased from early stage*9
Understanding pathophysiological changes caused by causative genes involved in the onset of DIAD, a familial Alzheimer’s disease, throughfunctional genetics

Pursue treatment opportunity, which inhibits the spread of aggregates by blocking propagation through capturing MTBRcontaining tau species extracellularly
Development of anti-tau antibody specific to MTBR

Pursue treatment opportunity for sAD, since MTBR-tau was found to increase in sAD*10

E2814, which inhibits tau aggregate propagation, is currently undergoing in-house Phase I study, Phase Ib/II study in DIAD, and Tau NexGen
study*11 by DIAN-TU*12*1: Investigational antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic. Collaboration with Biogen. *2: Amyloid precursor protein*3: Lars Lannfelt et al., The ‘Arctic’ APP mutation (E693G) causes Alzheimer’s disease by enhanced Aβprotofibril formation, Nature Neuroscience, 4, 887-893 (2001) *4: Aβ protofibrils are said to have high toxicity in soluble amyloidbeta aggregates. Pettersson E. F. et al., Large Aggregates Are the Major Soluble Ab Species in AD Brain Fractionated with Density Gradient Ultracentrifugation.: PLoS ONE, February 15, 2012
*5: Investigational. Discovered as part of the research collaboration between Eisai and University College London *6: Cerebrospinal fluid*7: Gene mutation is confirmed in either of 3 genes in PSEN1, PSEN2 or APP *8: Microtubule binding region*9: Horie K. et al., Comprehensive CSF Tau profiling identifies soluble Tau pathophysiological stages in dominantly inherited Alzheimer network (DIAN): Implications for the DIAN-TU Tau Next Generation Platform, AAIC2022, July 31 –Aug 4, San Diego, USA *10: Horie K. et al., CSF tau microtubule binding region identifies tau tangle and clinical stages of Alzheimer’s disease, Brain. 2021 Mar 3;144(2):515-527
9*11: Tau NexGen : Study name (Tau Next Generation). Phase II/III study in DIAD *12: Dominantly Inherited Alzheimer Network Trials Unit

Lecanemab*1

Multiple studies are ongoing to maximize value for patients
Realization of patient benefits through the development of new administration methods• Development of subcutaneous formulation: Seeking potential reduction of administration time and self-injection at home
Substudy of subcutaneous administration (including auto-injection) is ongoing in Study 301 (Clarity AD)-OLE*2, with the aim offiling for regulatory submission in FY2023• Development of maintenance dosing regimen: Aiming to reduce administration frequency after brain Aβ clearance
Substudy of maintenance dosing (once every 4 weeks, once every 12 weeks) after 18 months of lecanemab treatment isongoing in Study 201-OLE, and is seeking the potential optimal maintenance dosing regimen

Aiming to establish evidence through long-term administration• Following Core study, administration is planned up to 5 years for 201-OLE and up to 4 years for 301-OLE,with continuing administration to patients for a longer period, and monitoring for safety, biomarkers and so on.
• Long-term administration of lecanemab in patients with dominantly inherited Alzheimer's disease is planned in
DIAN-TU*3 Tau NexGen*4 study

Seeking earlier treatment opportunity by obtaining the indication for treatment of preclinical AD• AHEAD3-45 study (Phase III study, 54 months administration) in collaboration with ACTC*5 is ongoing

Aiming for a comprehensive and longer-term contribution to patients
following the results of Clarity AD*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: Open Label Extension*3: Dominantly Inherited Alzheimer Network Trials Unit *4: Tau NexGen : Study name (Tau Next Generation). Phase II/III study in DIAD *5: Alzheimer's Clinical Trials Consortium

10

Current Status of Amyloid Diagnosis and Future Perspectives
Current status of amyloid diagnosis methods in Japan and U.S.
MCI*1
Japan
AD
MCI
U.S.
AD

PET*2
CSF*3
Blood biomarkers
PET
CSF
Blood biomarkers
PET
CSF
Blood biomarkers
PET
CSF
Blood biomarkers

Regulatory approval
Amyloid
Tau

Reimbursement
Amyloid
Tau

×
〇*4
〇*4
〇
〇
〇

×
〇
×
×
〇
×

×
×
×
×
×
×

×
×
×
×
〇
×

〇
〇
LDT*6
〇
〇
LDT

〇
×
×
〇
×
×

CED*5
×
×
CED
×
×

×
×
×
×
×
×

Amyloid diagnosis methods are not yet reimbursed in Japan and U.S.
Environments expected at the launch of DMT*7

Amyloid PET/CSF tests are reimbursed including MCI indication and the environment for clinical use is in place based on the guidelines
formulated by related conferences and the guidelines for proper use. As for PET examination, implementation system is expanding by enhancing
the number of imaging authentication facilities*8 and related staffs. For CSF, lumbar puncture is becoming prevalent through conferences and theopportunity to undergo testing is secured nationwide*9.

Future expectations for amyloid diagnosis methods
Blood biomarker tests are widely used in medical care as a result of the accumulation of real-world evidence, and in the future, establishment of
diagnostic methods equivalent to the amyloid PET/CSF tests and securing of opportunities for treatment with DMT is expected.
Above is based on internal research. *1:Mild cognitive impairment *2: Positron emission tomography *3: Cerebrospinal fluid *4 The guidelines for proper use of CSF/blood biomarkers for dementia state that their clinicalusefulness for MCI is limited. *5: Coverage with evidence development *6: Laboratory developed test *7: Disease-modifying treatment *8: Certified by Japanese Society of Nuclear Medicine *9: Japan11

Eisai’s Subsequent AD Projects
E2814 (Anti-MTBR*2 tau antibody)

Pursuing expansion to sporadic AD, in-house Phase I study (effective
dose study*3) and Phase Ib/II study for DIAD*4 are ongoing.
In addition, Tau NexGen study*5 is ongoing by DIAN-TU*6
Potentially inhibits transcellular spread of MTBR tau and suppresses
the proliferation of tau aggregates

Lecanemab*1

Aβ protofibrils clearance

Tau aggregates cause synaptic damage
and subsequent neuronal cell deathProtofibrils

E2025

Synaptic
retraction

Activated
EphA4

Promotes tau
phosphorylation

Intracellular MTBR tau
promotes in solubilization ofphosphorylated tau

Lecanemab

AmyloidplaqueAstrocyte

E2025 (Anti-EphA4*7 antibody)

Phosphorylation of tau
MTBR taupropagation species
Phosphorylated
tau

E2511
E2814

E2511 (TrkA*8 binding synapse regenerant)

Investigation of optimal pharmacodynamics marker inongoing Phase I is under consideration
Potentially restores synaptic function by activating TrkA
and regenerates damaged axons of cholinergic neuron

Aiming to initiate Phase I in FY2022
By inhibiting EphA4 activation andsuppressing synaptic retraction andtau phosphorylation, E2025
potentially regenerates the dendritesof damaged glutamate neurons and
TrkA
restores synaptic function
Neuronal regeneration
Improved synaptic function

All projects are investigational. *1: Investigational antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic. Collaboration with Biogen*2: Microtubule binding region *3: Evaluation of pharmacodynamics *4: Dominantly inherited Alzheimer’s disease *5: Tau NexGen : Study name (Tau Next Generation). Phase II/III study in DIAD
*6: Dominantly Inherited Alzheimer Network Trials Unit *7: Erythropoietin-producing hepatocellular receptor A4 *8: tropomyosin receptor kinase A

12

Drug Discovery for Neurodegenerative Diseases
through Collaboration with Academia
EKID

Eisai-Keio Innovation Lab for Dementia

Research based on the high-quality clinical samples,
including centenarian samples held by Keio
University School of Medicine(AMED*1 funding: FY2017-2026)
There are facilities and researchers using cuttingedge technologies such as multi-omics, iPS*2 cells,
and human organoids
Leading drug discovery through elucidation of brain
robustness and homeostasis function
Milestone 1 (FY2017-2021): Brain clearance enhancement⇒ Milestone 1 achieved and under preparation to initiate
synthetic research
Milestone 2 (FY2021-2023): Brain homeostasis improvement
Milestone 3 (FY2024-2026): Neural network activation

UCL

University College London

UCL is one of the world‘s top research institutes in
the field of neurodegenerative diseases. Eisai has
a 10-year collaboration with UCL in this field.
Academic dementia research in the UK is centeredin DRI (Dementia Research Institute: a consortiumof seven universities). UCL is a core research
institute.
• E2814*3: Anti-MTBR*4 tau antibody for treatment of AD• Project 1: TREM2*5 function coordination (small molecularcompound) for treatment of AD• Project 2: Maintenance of mitochondrial homeostasis(small molecule compounds) for treatment of PD*6
• Project 3: Restoration of lysosomal function (small
molecular compound) for treatment of PD

All projects are investigational*1: Japan Agency for Medical Research and Development *2: Induced pluripotent stem *3: Discovered as part of the research collaboration between Eisai and University College London *4: MTBR: microtubule binding region*5: TREM2: Triggering receptor expressed on myeloid cells 2 *6: Parkinson's disease13

Eisai R&D

New R&D organization initiated underDeep Human Biology Learning (DHBL) structure
Targeting of neurodegenerative diseases focused on AD
and refractory cancers remains unchanged

Establishment of DHBL drug
discovery hypothesis basedon genome information linked
to the underlying cause of
disease andpathophysiologicalinformation(five drug discovery areas)

Human Biology Integration Group
ProteinIntegrity &Homeostasis

Microenvironment
Dynamics

Cell lineage &Differentiation

Inflammaging &Senescence

Clinical data,biomarker dataand cohort dataobtained fromhigh-quality in-houseclinical researchDiscovery Concept
Validation Group

Verification of DHBL drug discovery
hypotheses and selection of optimalmodalities in preclinical models by
maximizing chemistry capabilities

Microbes &Host Defense

Discovery Evidence
Generation Group
Pharmaceutical
Profiling & Development Group

Prove DHBL drug
discovery hypothesis
in humans by clinicalstudy using advanced
statistical analysis method

Clinical Evidence Generation GroupEisai’s proprietary knowledge in Human Biology
Drug Discovery based on genome information obtained from high-quality clinical samples

14

Efforts toward Realization of Inclusive Society
Together with Local Governments

Eisai will continue to make consistent efforts to realize an inclusive society
Established community development division with the aim of realizing an inclusive society, working together with local governments and residents since2008. Currently, agreements are signed with 167 local governments to create dementia communities where people can live with peace of mind.
Actively held lectures would lead to the creation of opportunities for local governments to connect and the realization of a co-existing society through theonline “Community Development Meeting for Consideration of Co-existence and Prevention.” A total of 567 local governments participated.
Bunkyo Ward, Tokyo

Gifu Prefecture

Taketa City, Oita Prefecture

I want to stay connected withsociety
I want to keep working

I want to keep driving as longas possible

I want to know the healthcondition of my brain and dowhat I can

I want a place where I caneasily gather with people

I'm worried about dementia,
but I can't easily talk about it

Employment support"Iki-Iki" Driving and
Health class

Bunkyo dementia screening

Tsuyukusa-so gathering
space creation project

Dementia care promotion center
Kakekomachi Shichiken-choCreate employment
opportunities at the Naito
Museum of Pharmaceutical
Science and Industry for
individual who needed to retiredue to early-onset dementia

Based on health-related
information we provided, raiseawareness of dementia
prevention and safe driving
through follow-up activities forparticipants toprevent nursing care

Approximately 12,000 people
who will turn 55 to 75 years old
are measured for their brain
health, etc. Systems are created
where anxious people canreceive consultation and enjoysocial interaction opportunities

Create gathering places forresidents of Bunkyo Ward andpeople at Atomi University togive them opportunities to talkabout dementia and implement
exercises that are said to begood for brain healthA base where anyone cancasually stop by to learn aboutbrain health. Medical andnursing care professionals are
stationed at the center, so
people can feel free to receive
consultation about dementia.

Shizuoka City, Shizuoka Prefecture

15

For 25 years since the approval of Aricept,
people living with AD and their families kept asking us,“When will the next drug come out?”
We have never forgotten the serious expressions in their faces
and sparks in their eyes, not even for a moment.
We are doing our utmost to obtain approval of lecanemab
and realize access to it, and we are working with industry,
government, and academia to find ways to help people living withdementia and their families live safely with peace in mind.
16

Reference Data

17

Revenue by Reporting Segment(Billions of yen, %)April-September 2021
Results

April-September 2022%

Results

YoY

％

Japan

104.0

28.7

110.6

30.8

106

Americas*1

75.4

20.8

106.4

29.7

141

China

55.3

15.3

63.3

17.6

115

EMEA*2

28.0

7.7

35.0

9.7

125

Asia and Latin America*3

24.6

6.8

24.8

6.9

101

OTC and others (Japan)

12.1

3.4

12.6

3.5

104

Pharmaceutical business total

299.4

82.6

352.6

98.3

118

Other business*4

62.9

17.4

6.1

1.7

10

Consolidated revenue

362.4

100.0

358.6

100.0

99

Indicates revenue from external customers. The figures for FY2021 have been revised for retroactive application due to changes in accounting policies.
From FY2022, Hong Kong was changed from Asia and Latin America pharmaceutical business to China pharmaceutical business. *1: North America *2: Europe, Middle East, Africa, Russia and Oceania *3: Primarily South
Korea, Taiwan, India, ASEAN, Central and South America*4: Income mainly from license and the pharmaceutical ingredient business of the parent company. From FY2022, upfront payments and other factors received as consideration for license grants have been included in “Other
business”. These changes for the FY2021 have been reflected in Segment Information.

18

Profit by Reporting Segment(Billions of yen, %)April-September 2021
Results

April-September 2022

％ ofrevenue％

Results％ ofrevenue

％

YoY

Japan

32.7

16.9

31.5

37.7

21.6

34.1

115

Americas*1

41.8

21.6

55.5

64.4

37.0

60.6

154

China

31.3

16.1

56.6

35.3

20.3

55.8

113

EMEA*2

15.3

7.9

54.5

20.5

11.8

58.7

134

Asia and Latin America*3

10.8

5.6

43.8

11.8

6.8

47.7

110

OTC and others in Japan

2.9

1.5

23.7

3.3

1.9

25.8

113

Pharmaceutical business total

134.7

69.5

45.0

173.0

99.3

49.1

128

Other business*4

59.0

30.5

93.7

1.3

0.7

20.9

2

Reporting segment total

193.7

100.0

53.5

174.3

100.0

48.6

90

R&D expenses and Group headquarters’
management costs and other expenses*5(133.0)--(169.0)--127

Consolidated operating profit

60.7

-

16.8

5.3

-

1.5

9

The figures for FY2021 have been revised for retroactive application due to changes in accounting policies. *1: North America *2: Europe, Middle East, Africa, Russia and Oceania *3: Primarily South Korea, Taiwan, India, ASEAN, Central and South America*4: Income mainly from license and the pharmaceutical ingredient business of the parent company *5: Including the amounts of profits and expenses shared with partners under strategic collaborations.
The amount of shared profit of Lenvima paid by Eisai to Merck & Co., Inc., Rahway, NJ, USA was 41.4B yen in Q2 FY2021 and 61.0B yen in Q2 FY2022.
Of 110 million USD (for April 2022 - December 2022), which is the remaining amount of Eisai's share of Alzheimer's disease treatment ADUHELM related expenses capped at 335 million USD, 72 million USD is recorded in selling, general and administrative
expenses, and research and development expenses in Q2 FY2022. As the co-development and co-promotion agreements for ADUHELM with Biogen Inc. were changed in March 2022, all relevant expenses (selling, general and administrative expenses) that thecompany should share have been included in the “Group headquarters’ management costs and other expenses” since FY2022. In addition, gains and losses on sale of non-current assets have been included in the “Group headquarters’ management costs andother expenses”. As a result, these changes for the FY 2021 have been reflected in Segment Information.

19

Revenue of Major Products(Billions of yen, %)LenvimaJapan
Americas
China
EMEA
Asia and Latin America

April-September 2021
Results
％
91.8
100.0
5.1
5.6
51.3
55.9
21.3
23.2
10.0
10.9
4.1
4.5

Results
128.2
6.9
80.2
20.7
15.0
5.4

April-September 2022
YoY
％
100.0
140
5.4
134
62.5
156
16.2
97
11.7
150
4.2
131

［118］
［134］
［128］
［83］
［133］
［114］

HalavenJapan
Americas
China
EMEA
Asia and Latin America

19.9
4.1
6.9
1.3
6.5
1.2

100.0
20.6
34.5
6.5
32.5
5.9

21.4
4.3
7.7
1.1
6.8
1.5

100.0
20.0
35.9
5.4
31.9
6.8

107
104
112
89
105
124

［95］
［104］
［92］
［76］
［93］
［108］

Fycompa
Japan
Americas
China
EMEA
Asia and Latin America

15.2
2.6
7.0
0.5
4.3
0.7

100.0
17.1
46.1
3.4
28.6
4.8

20.1
3.0
9.4
1.3
5.5
0.9

100.0
15.2
46.9
6.3
27.4
4.2

133
118
135
249
127
118

［117］
［118］
［111］
［213］
［116］
［106］

DayvigoJapan
Americas
Asia and Latin America

6.3
4.7
1.6
-

100.0
74.4
25.3
-

13.6
11.1
2.3
0.1

100.0
81.8
17.2
0.5

214
236
145
-

［208］
［236］
［120］
-

[ ] based on local currency

20Performance ofJapan Pharmaceutical Business(Billions of yen, %)April-September 2021
Results

April-September 2022
Results％

YoY％

Revenue(Prescription medicines)

104.0

100.0

110.6

100.0

106

HumiraAricept

24.8
4.7
5.1
5.3
4.1
3.4
2.9
2.6
0.3
3.3
2.3
3.6

23.9
4.5
4.9
5.1
3.9
3.3
2.8
2.5
0.3
3.2
2.2
3.5

24.7
11.1
6.9
5.3
4.3
3.6
3.3
3.0
3.0
3.0
2.8
2.3

22.3
10.1
6.2
4.8
3.9
3.3
3.0
2.8
2.8
2.7
2.6
2.1

99
236
134
101
104
107
114
118
895
90
125
64

Segment profit

32.7

31.5

37.7

34.1

115

DayvigoLenvima
Methycobal
Halaven*1

ElentalGoofice*1
Fycompa
Jyseleca
Pariet *1,2
Movicol *1*1: EA Pharma product *2: Includes sales of triple formulation Helicobacter pylori eradication packs (Rabecure Pack 400/800 and Rabefine Pack)

21

Performance ofAmericas* Pharmaceutical Business(Billions of yen, %)April-September 2021
Results

April-September 2022
Results％

YoY％

Revenue

75.4

100.0

106.4

100.0

141

［116］

Lenvima

51.3

68.1

80.2

75.3

156

［128］

Fycompa

7.0

9.3

9.4

8.9

135

［111］

Halaven

6.9

9.1

7.7

7.2

112

［92］

Dayvigo

1.6

2.1

2.3

2.2

145

［120］

Banzel

4.7

6.2

2.0

1.9

43

［35］

41.8

55.5

64.4

60.6

154

［134］

Segment profit[ ] based on local currency* North America

22Performance ofChina Pharmaceutical Business(Billions of yen, %)April-September 2021
Results

April-September 2022
Results％

YoY％

Revenue

55.3

100.0

63.3

100.0

115

［98］

Lenvima

21.3

38.5

20.7

32.8

97

［83］

Methycobal

6.6

12.0

8.4

13.3

127

［109］

Pariet

4.6

8.3

4.9

7.7

106

［91］

Stronger Neo-Minophagen C and
Glycyron Tablets

5.3

9.6

4.5

7.0

84

［72］

Aricept

2.6

4.7

3.4

5.4

130

［111］

Fycompa

0.5

0.9

1.3

2.0

249

［213］

Halaven

1.3

2.3

1.1

1.8

89

［76］

Segment profit

31.3

56.6

35.3

55.8

113

［98］

[ ] based on local currency

23Performance of
EMEA* Pharmaceutical Business(Billions of yen, %)April-September 2021
Results

April-September 2022
Results％

YoY％

Revenue

28.0

100.0

35.0

100.0

125

［113］

Lenvima/Kisplyx

10.0

35.6

15.0

42.9

150

［133］

Halaven

6.5

23.1

6.8

19.5

105

［93］

Fycompa

4.3

15.5

5.5

15.7

127

［116］

Inovelon

1.3

4.8

1.5

4.3

112

［103］

Segment profit

15.3

54.5

20.5

58.7

134

［114］

[ ] based on local currency* Europe, Middle East, Africa, Russia and Oceania

24Performance of Asia and Latin America*
Pharmaceutical Business(Billions of yen, %)April-September 2021
Results

April-September 2022
Results％

YoY％

Revenue

24.6

100.0

24.8

100.0

101

［90］

Aricept

5.9

24.1

6.7

27.0

113

［103］

Lenvima

4.1

16.8

5.4

21.9

131

［114］

Pariet

2.1

8.5

2.2

8.7

102

［92］

Methycobal

1.7

7.0

1.8

7.5

107

［94］

Halaven

1.2

4.8

1.5

5.9

124

［108］

Fycompa

0.7

2.9

0.9

3.4

118

［106］

Segment profit

10.8

43.8

11.8

47.7

110

［96］

[ ] based on local currency* Primarily South Korea, Taiwan, India, ASEAN, Central and South America

25Performance of
OTC and Others in Japan(Billions of yen, %)April-September 2021
Results

April-September 2022
Results％

YoY％

Revenue

12.1

100.0

12.6

100.0

104

Chocola BB Group*

7.3

59.9

7.7

61.2

106

Segment profit

2.9

23.7

3.3

25.8

113

* Vitamin B preparations, “Chocola BB Plus” and others

26

Overview of Anti-Aβ Antibody Clinical Trial Designs
Drug(Sponsor)

Study name(Stage)Target population(Estimated enrollment)

Dose

Inclusion criteria (partial)

lecanemab*1(Eisai, Biogen)

Phase II
(Bayesian adaptive
design)

Early AD(856)

2.5mg/kg, 5mg/kg(biweekly, monthly),
10mg/kg (biweekly,monthly), placebo

lecanemab*1(Eisai, Biogen)

Clarity AD(Phase III)

Early AD(1906*2)

10mg/kg biweekly,
Placebo

MCI due to AD and mild AD-D （NIA-AA）
CDR 0.5-1, CDR memory box ≧0.5, MMSE 22-30,
WMS-IV LM II: 1 SD below age-adjusted mean,amyloid positive
MCI due to AD, mild AD (NIA-AA),
CDR: 0.5-1, CDR memory box ≧0.5, amyloid positive,
MMSE≧22, WMS-IV LMII: 1 SD below age-adjusted meanlecanemab*1(Eisai, Biogen, ACTC, NIA)AHEAD 3-45
(Phase III)

Preclinical AD (1400)

5mg/kg + 10mg/kg,
Placeboaducanumab(Biogen, Eisai)

ENGAGE (Phase III)

Early AD (1647)

EMERGE (Phase III)

Early AD (1638)

TRAILBLAZER-ALZ(Phase II)

Prodromal to mild AD(272)

TRAILBLAZER-ALZ 2(Phase III)

Early AD (1800)

donanemab,
placebo

MMSE: 20-28, meet F flortaucipir and F florbetapir PET
scan (central read) criteria

iADRS(76 weeks)

TRAILBLAZER-ALZ 3(Phase III)

Preclinical AD (3300)

donanemab,
Placebo

Telephone Interview for Cognitive Status-modified (TICS-M)
score reflective of intact cognitive functioning. Has a
phosphorylated tau (p-tau) result consistent with the presenceof amyloid and early-tau pathology.

Time to clinical progression by Clinical
Dementia Rating-Global Score(CDR-GS) (up to 182 weeks)

Probable AD dementia or prodromal AD (NIA-AA),amyloid positive, MMSE≧22, CDR-GS: 0.5 or 1.0

CDR-SB(116 weeks)

donanemab(Eli Lilly)

Low dosehigh doseplacebo
700mg/kg Q4W x3,
1400mg Q4W up to 72W,
placebo

Graduate I (Phase III)

Early AD (1016)

Graduate II (Phase III)

Early AD (982)

SKYLINE(Phase III)At risk for or at the earliest
stages of AD (1200)

gantenerumab,(Washington University
School of Medicine)

DIAN-TU-001(Phase II/III, OLE)

Cognitively normal or with
MCI or mild dementia*3(490)

gatenerumab

crenezumab(Genentech,Roche)

API ADAD
Phase II

Preclinical AD(252)

crenezumab,
placebogantenerumab(Roche)gantenerumab (SC),placebo

Efficacy measurement(Primary endpoints)
ADCOMS(12 months)
CDR-SB(18 months)

CDR: 0, MMSE≧27, WMS-R LM II≧6
A3: Intermediate levels of brain amyloid pathology
A45: Elevated brain amyloid pathology

A3: Amyloid PET SUVr (216 weeks)
A45: Preclinical Alzheimer Cognitive
Composite 5 (PACC 5) (216 weeks)

MCI due to AD or mild AD, CDR-Global Score: 0.5,
MMSE≧24, amyloid positive

CDR-SB
(78 weeks)

18

MMSE: 20-28, meet F flortaucipir PET scan criteria
18
and F florbetapir PET scan (central read) criteria
18

18

Cognitively unimpaired with CDR-GS of 0 and RBANS DMI>=80, cerebral amyloid accumulation
Have an AD-causing mutation or are unaware of their genetic
status and have dominantly inherited AD (DIAD) mutation in
their family. Cognitively normal or with mild cognitive
impairment or mild dementia, CDR: 0-1
PSEN1 E280A mutation carrier kindred,
MMSE≧24 (less than 9 years of education) or MMSE≧26(9 or more years of education), not meet the criteria fordementia due to AD, MCI due to AD

Integrated Alzheimer‘s Disease Rating
Scale (iADRS) (18 months)

PACC-5 (4 years)
DIAN-Multivariate Cognitive Endpoint(DIAN-MCE)(52, 104, 156, and 208 weeks)
API ADAD Composite Cognitive Test
Total Score (260 weeks)

Study design overview for Phase II and beyond in this chart was edited by Eisai based on ClinicalTrials.gov as of October 28, 2022. OLE studies are not included except for DIAN-TU-001. All projects are investigational except for aducanumab in the U.S.
*1: Investigational antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic. *2: Includes 111 subjects in China *3: Target population for this trial is individuals at risk for or with a type of early
onset Alzheimer's disease caused by a genetic mutation27

Pipeline in Oncology Area
Oncology pipeline

Non-clinical trials

Phase I

Phase II

*1

1L Hepatocellular carcinoma (LEAP-002)
1L Melanoma (LEAP-003)*1*1

1L Non-small cell lung cancer*3 (LEAP-006)

LenvimaCombination
with
KEYTRUDA®

2L Non-small cell lung cancer (LEAP-008)*1

1L Head and neck cancer (LEAP-010)
1L Hepatocellular carcinoma(combination with TACE*4, LEAP-012)
1L Esophageal carcinoma (LEAP-014)
1L Gastric cancer (LEAP-015)*1

3L Colorectal cancer (LEAP-017)
2L Melanoma (LEAP-004)
Basket trial*5 (LEAP-005)
Combination with KEYTRUDA
or everolimus
Combination with nivolumab*6
E7090

FGFR1,2,3 inhibitor

H3B-6545 ERα inhibitor
E7389-LF Liposomal formulation

E7386*7

CBP/β-catenin inhibitor

STING agonist

Approved

Achieved LPI
Expanding sample size

Achieved LPI

2L Head and neck cancer (LEAP-009)
1L Renal cell carcinoma (Study 307)
Hepatocellular carcinoma (Study 117)
Biliary tract cancer
Breast cancer
Breast cancer
Solid tumors
Solid tumors (combination with nivolumab)*6
Solid tumors
Hepatocellular carcinoma,
Solid tumors (combination with Lenvima)
Solid tumors (combination with KEYTRUDA)
Hepatocellular carcinoma

H3B-6527 FGFR4 inhibitor
Next-generation drug improving tumor
E7130*8
Solid tumors
microenvironment
MORAb-202*9 Antibody-drug conjugate (ADC)
Folate receptor α (FRA) positive solid tumors
E7766

Submission

Approved (Japan, U.S. and EU)
Achieved LPI*2
Achieved LPI
Achieved LPI
Achieved LPI
Achieved LPI
Achieved LPI

Endometrial carcinoma following prior systemic therapy (Study 309)
1L Endometrial carcinoma (LEAP-001)

Phase III

Combination with KEYTRUDA: Approved (Japan, U.S. and EU)

Phase I/II study
Phase Ib/II study
Phase Ib/II study

Phase Ib/II study

Phase I/II study

Solid tumors

Splicing modulator

Solid tumors

Protein degrader

Solid tumors

All projects are investigational unless stated “Approved”. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Projects for Lenvima are under joint development with Merck & Co., Inc., Rahway, NJ, USA. 1L: First line, 2L: Second line, 3L: Third line *1: Expanding sample size in China *2: Last Patient In*3: Non-squamous cell carcinoma, combination with chemotherapy *4: Transcatheter arterial chemoembolization *5: Gastric cancer, colorectal cancer, glioblastoma, biliary tract cancer, and pancreatic cancer*6: Development in collaboration with Ono Pharmaceutical Co., Ltd. *7: Collaboration with PRISM BioLab *8: Compound co-created with Harvard University *9: Co-development with Bristol Myers Squibb

28

Achievement of Milestones withMerck & Co., Inc., Rahway, NJ, USA
Sales milestone payment
recognized upon achievement of
1.5 billion USD revenue FY2021:
300 million USD (34.7 billion yen)
Sales milestone payment
recognized upon achievement of
1.2 billion USD revenue
from January to December 2020:
200 million USD (20.7 billion yen)

Sales milestone payment recognized
upon achievement of 1.4 billion USD
revenue from January to December 2021:
300 million USD (34.5 billion yen)

Regulatory milestone payment for theapproval of thyroid cancer indication in
China: 10 million USD (1.0 billion yen)
Reversal of R&D expenses

Regulatory milestone payment for theapproval of renal cell carcinoma
indication in Japan:
25 million USD (2.9 billion yen)
Reversal of R&D expenses

One-time option payment associatedwith certain option rights: 125 million
USD (12.9 billion yen)

Regulatory milestone payment for theapproval of renal cell carcinoma
indication in US:
75 million USD (8.3 billion yen)
Reversal of R&D expenses

Regulatory milestone payment for theapproval of renal cell carcinoma in EU:
25 million USD (3.2 billion yen)
Reversal of R&D expenses (1Q)

FY2020 results
335 million USD (34.6 billion yen)

FY2021 results
700 million USD (80.3 billion yen)

Q2 FY2022 cumulative results
25 million USD (3.2 billion yen)

Chart not to scale

29

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 accordancewith 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 andresults to differ materially from these statements.
 Risks and uncertainties include general industry and market conditions, and general domestic and international economic conditions suchas interest rate and currency exchange fluctuations. Risks and uncertainties particularly apply with respect to product-related forwardlooking statements. Product risks and uncertainties include, but are not limited to, technological advances and patents attained bycompetitors; challenges inherent in new product development, including completion of clinical trials; claims and concerns about productsafety 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 notlimited 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).
30