Information Meeting
March 10, 2023

Eisai Co., Ltd.

Topic 1： Business Model Driven by
the Articles of Incorporation
hhceco model

Topic 2： Aim to Replicate LEQEMBI’s Success*

Topic 3： Pricing based on Societal Value(Value-based pricing)
Topic 4： LEQEMBI Updates
Topic 5： Future Scenarios
LEQEMBI: Antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic. Collaboration with Biogen. Generic name: lecanemab.
* Success in drug development

1Topic 1
Business Model Driven by
the Articles of Incorporation

The hhceco model2

Articles of Incorporation of Eisai(Corporate Philosophy) Article 2.
The Company’s Corporate Philosophy is to give first thought to patients and the general public, and to increase the benefits that
health care provides to them. Under this Philosophy, the Company endeavors to become a human health care (hhc) company.
2.

The Company seeks to effectively achieve social good in the form of relieving anxiety over health and reducing healthdisparities as a Japanese innovation company.

3.

The Company’s mission is to increase the satisfaction of patients and the general public, and to empower people in the dailyliving and medical domains to realize their fullest life through an hhc ecosystem based on collaboration with other industries.
The Company believes that revenues and earnings will be generated by fulfilling this mission. The Company places
importance on this sequence of placing the mission before the ensuing results.

4.

The Company strives to fulfill its social responsibilities by positioning compliance (i.e., the observance of legal and ethicalstandards) as the basis of all business activities.

5.

The Company’s principal stakeholders are patients and the general public, shareholders and employees. The Company
endeavors to develop and maintain a good relationship with stakeholders and to enhance the value of their stake through:
1.Satisfying unmet medical needs, raising awareness of illnesses and providing information and services that help prevent
them, ensuring a stable supply of high-quality products, and providing useful information on subjects including drug
safety and efficacy;

2.Contributing to a sustainable society with a long-term perspective;
3.Enhancement of common interests of shareholders and long-term corporate value, a positive return to shareholders andtimely disclosure of corporate management information; and4.Ensuring stable employment, respecting human rights and diversity, providing full opportunities for growth to support
self-fulfillment, and creating an employee-friendly environment.
Excerpt from the Articles of Incorporation

3

Eisai hhceco Model in Dementia
Social impact (People living with AD, their families, caregivers, HCPs, payers, governments, shareholders and employees)

The
PeopleHigh-risk

Healthy

Onset/treatment

Education/
provision

Follow-up/prognosis

Provision

Provision

Provision

Provision(Healthy)
Solution

Inclusion
・Patient advocacy

groups・Local governments

Collaboration• Prediction of risks for
onset• Disease awareness• Genetic test
• Wearable/healthcare
app (obtaining PHR*2
and others)

Collaboration

Solution• Building an inclusive
society• Introducing facilities
for elderly people• ePRO*4

Drug discovery research based on human biology evidence,by viewing disease as a continuum
Genome data fordisease

Genome data bank
• Japan HealthResearch Promotion
Bureau• J-ADNI*1• e-65.net• NouKNOW ®*3• Online
community/consultation• PET/CSF• Blood-based
biomarker(Follow-up/
prognosis)(Onset/treatment)
Solution• Real Medicine• Digital Medicine• Prediction of risks
for progression• Visualization oftreatment effectIndustrycollaboration
Collaboration• Insurance• Communication• Financial• Automobile• Fitness• FoodR&D based on DHBL (Deep Human Biology Learning) structure

Academia• University College
London• Keio University• Washington University
in St. Louis(High-risk)
Solution

Provision of data

• Genome data fordementia, which is
expected to expand

Data fromclinical studies*5• LEQEMBI Clarity AD(most recent andimportant findings of AD)• Elenbecestat• Aricept

Start-up companies
Collaboration

RWD*6/PHR data
• Follow-up data of people
received treatment• Medical examination/bio
data• Cohort data

• Bio/drug discovery
venture• DTx*7 venture

Monitoring/
PHR partners
Provisionof data• Medical device• PHR app/
medical checkup

Realize the Articles of Incorporation
Potential funding through sustainable financing with social impact targets as KPIs
*1: Japanese Alzheimer’s Disease Neuroimaging Initiative *2: Personal Health Record*3: Self-checking tool (non-medical device), which individuals can check their cognitive functions by themselves with quantified brain performance data through simple card games utilizing PC or tablet-type device. *4: Electronic Patient Reported Outcome*5: Investigational antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic. Collaboration with Biogen. Generic name: lecanemab *6: Real World Data *7:Digital Therapeutics

4Building the Dementia Ecosystem

Aiming to relieve anxieties by providing Solution Packages

Anxieties

Aging

High-risk

Medical consultation
Clinical diagnosis• I want to stay healthy.
Is it possible toprevent dementia?
• I am anxious about
recently getting moreforgetful• When would
symptoms appear?
• I do not know where I
should go for a
medical consultation• There is no medical
institutions nearby,
where should I go toreceive cognitive
function test?
• I feel anxious everyday
when I think of myfamilyDefinitive diagnosis• I want to know if I
have AD, but I’mafraid of being
diagnosed• There is no treatment
option for people withnegative AβPenetration of disease Building an environment to Building an environment Building an environment
awareness andunderstand the brain health that enables consultation
to enable Aβ test
understanding
and clinical diagnosis• Collaborate with CSF*4• Implementing checkup forwherever you live
Aβ test companies

Solution
Packages e-65.net
 Partnership with;
Honda Motor Co., Ltd.,LIFENET INSURANCECOMPANY, Tokio Marine& Nichido Fire InsuranceCo., Ltd., Saitama Resona
Bank, Limited, E.design
Insurance Co., Ltd., ITO
EN, LTD. and others

forgetfulness at 46 local
governments including
Bunkyo-ward, Tokyo,
Aki City, Kochi prefecture,
Minami-Echizen-cho,Fukui prefecture andothers• Implementing brain healthcheck under brain checkup
at 100 medical institutions

Confirm brain health

Building environment toconnect with specialists

Smartphone developed andmanufactured by FCNT isequipped with
NouKNOW ®*1, a digital tool
for self-assessment of brain
performance (brain health)Click-Karte• Understand your healthstatus by explaining detailsof your PHR*2• Compile the results ofblood tests and healthcheckups

Website, which supports
people to find medical
institutions to consult forforgetfulness

AI to predict onset risk
Develop AI that can predict
future risks of MCI and giveindividual advice• Build an environment toprovide CDR*3 tests• Support to educate
clinical examiners• Spread know-hows
for CDR tests• Implement a simple andaccurate tool formeasuring cognitive
function• Provide solutions thatenable telemedicine andremoteneuropsychological test

AI to predict
progression risk
Develop AI that predicts
how much progress will bemade from individual input
information• Collaborate with Amyloid
PET test companies• Collaborate with companies
developing blood-based
biomarker

Building an environment to enableAβ test at local communities• Establishment of inter-facility
collaboration in eachregion/medical area

Proposal in caseAβ is negative• "Brepacise" (brain
performance + exercise)• Create a meeting space forresidents in collaboration
with local governments

Treatment

Preparation
for careEvaluation/
monitoring• I want to continue to • I'm on treatment, but
live my life without
am I really gettingchanging my living
better?
environment• I want to be treated,• I want to continue
treatment as long as but I'm worried aboutside effects.
possible• I don't want to bea burden on myfamily• I want to live as I
am

Development and realization of novel
treatment agents, in addition to conventional
treatment

Develop an inclusive
society

Building an environmentthat enables treatment
wherever you live
• Development of anenvironment that enables
home administration• Building a medical
network by regions

Realization oftreatment effectDeveloping a simple
scale to measuretreatment effect

Robust ARIA*5
management
ARIA education
program• Initiatives to create
communities where
people can live withpeace of mind together
with local governments• Community development
partnership agreementwith167 communities

Spread of bestpractice• Seminars utilizing virtual
spaces• Provide the booklet,
introducing best practiceof local governments‘Insurance/loan for dementia’ to improve access to AD treatments
and savings for dementia preparedness

AI to predict treatment effect of LEQEMBIAI to find ARIA

Develop AI centered on clinical trial data that can
individually calculate what kind of course one will
follow when LEQEMBI is administrated

Develop AI
to find
ARIA

ePRO*6Focus on ADL and visualize ADL
status through record of daily
conditions by the patient or theirfamilies

Above includes projects under consideration *1: Self-checking tool (non-medical device), which individuals can check their cognitive functions by themselves with quantified brain performance data through simple card games utilizing PC or tablet-type device.
*2: Personal Health Record *3: Clinical Dementia Rating *4: Cerebrospinal fluid *5: Amyloid related imaging abnormality *6: Electronic Patient Reported Outcome

5

Utilization of Digital Technology in China
One-stop online health platform: Yin Fa Tong
One-stop online health platformfrom daily life to medical treatment*1

Number of registered physicians

Over 4,800 (as of February 3, 2023)
HCPs

Over 94,000
Number of active users

User

Over 80% of physiciansbelong to tertiary hospitals*2(as of February 3, 2023)

Over 50% of physicians
are neurologists

User count for online medical consultation
Over 2,000 times in one year since the establishment of Yin Fa Tong platform( as of December 30, 2022)

Onlineshopping
mall

Healthrelated
information

Brain exercise
game

Evaluation of
cognitivefunction

Onlinemedicalconsultation

Enabling online medical consultation with neurologists
utilizing a network built through robust relationship with
KOLs since launch of Aricept

Aiming to relieve anxieties over health and reduce health disparities
by establishing hhceco model in China with Yin Fa Tong at the center*1: Online business by Jingyi Weixiang (Shanghai) Health Industry Development Limited Company, a joint venture of JD Health and Eisai China Holdings Ltd.
*2: A tertiary hospital is a comprehensive, referral, general hospitals at the city, provincial or national level with a bed capacity exceeding 500.

6

Development of Dementia Ecosystem in Emerging Countries
Insurance product to target full-stage AD was launched for the first time in Thailand●October 31, 2022
Eisai (Thailand) Marketing Co. Ltd. made an agreement with Thai Life Insurance Public Company Limited(TLI) to collaborate in supporting access to treatments for dementia, including Alzheimer's disease, in Thailand●February 15, 2023
TLI launched Prompt Pay 108, an insurance product that covers expenses for the treatment, including cost for
drugs if insurance subscribers are diagnosed with mild to moderate AD, for the first time in Thailand

Continue to collaborate to further enhance disease awareness and expand access
Cited from Thai Life Insurance website
Advertisement to notify coverage expansion of Prompt Pay108

Development of ecosystem
based on successful cases

Expand awareness utilizing people’s network• Eisai has implemented a number of diseaseawareness activities in-person/online so far

Online articles fordisease awareness• Expand disease awareness utilizing network
and asset, which are owned either throughEisai or partners, based on ecosystem

Expand collaboration with stakeholders• Aiming to expand ecosystem in Thailand throughcollaboration with other industries, including financial
industry• Initiated communication with non-profit organization andinsurance/financial companies in other Asian emerging
countries with the aim to develop an ecosystem

Aiming to contribute to improving disease awareness, early detection/diagnosis,
and expanding access to pharmacotherapy for dementia through ecosystem development
in collaboration with other industries in emerging countries in Asia, where population is aging rapidly
7Topic 2
Aim to Replicate
LEQEMBI’s Success*

LEQEMBI: Antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic. Collaboration with Biogen. Generic name: lecanemab.
*: Success in drug development

8

Patterns of Success in Drug Development
Obtained from LEQEMBI*
1. Based on robust human biology-based hypotheses, such as discoveries from academia(Right Hypothesis)

2. Implementation of diligent Phase II study
Ability to explore target population, dose and an endpoint(Right Target, Right Dosage and Right Endpoint)
3. Robust ability to conduct clinical research
Clinical Pharmacology (pharmacokinetics/pharmacodynamics simulation)
Sophisticated Statistics (optimal protocol design, monitoring of the progress)
Decentralized Clinical Trial(remote diagnosis, home visiting, remote cognitive assessment and safety monitoring)
4. Ability to calculate the value based on a disease simulation model
Implementation of value-based pricing*Antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic. Collaboration with Biogen. Generic name: lecanemab.

9Collaboration with Global Academia
as Foundation for DHBL*1 Drug Discovery
Academia is the frontline of human biology

UCL(University College London)• Drug discovery research starting fromthe deep biology of targets with high-genetic
evidence in collaboration with the world’s
top-class scientists
DHBL
drug
discovery

EKID

WashU

(Eisai-Keio Innovation Lab for Dementia)(Washington University in St. Louis)• Drug discovery for novel targets related tobrain robustness by combining centenariancohort studies and multi-omics studies• Drug discovery research of targets combining
cohort study for dominantly inherited
Alzheimer's disease (DIAN: The Dominantly
Inherited Alzheimer Network) and cutting-edge
biomarker research• Target validation using iPS cells *2 and brainorganoids*1: Deep Human Biology Learning *2: iPS cell: Cells that are created from introducing specific transcription factors into somatic cells such as skin tissue, are self-proliferating and can be differentiated into all types of tissues and cells.

10Analogy in Developmental Approach between Anti-MTBR Tau Antibody
E2814 based on DHBL , and LEQEMBIThe best approach for Eisai
Anti-MTBR tau antibody E2814
LEQEMBI*1*2• Dr. Lars Lannfelt, Uppsala University in Sweden, discovered that
*5
APP Arctic mutation , familial mutation increases Aβ protofibrils inthe brain*6 and develops high neurotoxicity, and Eisai initiated coresearch with BioArctic*7• Pursued the possibility of treatment by clearing brain Aβ
protofibrils*3*4

Origin• Under the collaboration with UCL, we focused on MTBR, which is a core for• In collaboration with UCL*8, discovered an antibody that binds with high affinity to
tau aggregates, and developed an antibody that binds to it.*9It is also found
MTBR, the core for tau aggregation. In collaboration with Wash U , it was found thatthat MTBR-tau in CSF was specifically increased at very early stage*10
MTBR-tau in CSF was specificallyincreased at very early stage observed by CSF*7
observed through CSF analysis in mutation carriers for dominantly inherited*11 *12analysis in mutation carriers for dominantly
inherited Alzheimer’s disease (DIAD )*8 *9
Alzheimer’s disease (DIAD )Hypothesis• Pursue the possibility of treatment by capturing MTBR-tau propagating species in theextracellular space, and prevent tau propagation
Microtubule-binding region10

MOA*13Presynaptic cell

Synaptic cleft

Presynaptic
cellcellPostsynaptic

Quantity×E2814

Relative abundance (compared to Control)

MTBR taupropagation species

MTBR tau
8
propagation species
6

E2814

MTBR

Control
Control
Very mildmild
to moderateADVery
to moderate
Severe AD AD
Severe354*14×

Profile of tau species
extracted from tangles NTF
ofAD brain299*14

4

Synaptic cleft

Postsynaptic cleft

2• E2814 specifically recognize R2 and E4 of MTBR, capture MTBR-tau
species inR2
theandextracellularspace, and may prevent tau• E2814 propagating
specifically recognize
R4
propagationof MTBR• Study 201 and Clarity AD*16: Demonstrated efficacy in sporadic
AD with pathophysiology consistent with familial AD in people withearly AD396-406

386-395354-369

275-280299-317243-254260-267

195-209226-230

151-155

45-67

68-87

6-23

• LEQEMBI has high affinity and selectivity to Aβ protofibrils, which isbelieved to be the most toxic, and clears them rapidly from brain

25-44

0

Residues

Region array of tau species*15

Targetpopulation

R2 R4• Phase Ib/II study: Evaluate safety, tolerability and interaction with CSF MTBR-tau
utilizing novel biomarker in people with DIAD with mild and moderate cognitive
function disorder• DIAN-TU*17Tau NexGen*18 Phase II/III study: Evaluate the efficacy in monotherapy
and combination with lecanemab for tau cumulation in the brain in people with DIAD
in preclinical AD stage to early AD stage

All projects are investigational except for Clarity AD for lecanemab *1: Microtubule binding region *2: Investigational. Discovered as part of research collaboration between Eisai and University College London*3: Deep Human Biology Learning *4: Antibody for
Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic. Collaboration with Biogen. Generic name: lecanemab. *5: Lars Lannfelt et al., The ‘Arctic’ APP mutation (E693G) causes Alzheimer’s disease by enhanced
Aβprotofibril formation, Nature Neuroscience, 4, 887-893 (2001) *6: 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 *7: Initiated co-research with
BioArctic in 2005. *8: University College London *9 Washington University in St. Louis *10: Cerebrospinal fluid *11: Gene mutation was confirmed in either PSEN1, PSEN2, or APP *12 Horie K. et al., Change in cerebrospinal fluid tau microtubule binding region
detects symptom onset, cognitive decline, tangles, and atrophy in Dominantly Inherited Alzheimer's Disease, Annals of Neurology 2023 https://onlinelibrary.wiley.com/doi/10.1002/ana.26620 *13: Mode of Action *14: The first sequence number of the amino acidfragment characteristically observed in MTBR region of AD patients *15: Adapted from Horie et al., Brain. 2021 Mar 3;144(2):515-527 *16: Phase III study for lecanemab targeting early Alzheimer’s disease *17: The Dominantly Inherited Alzheimer Network Trials
Unit *18: Tau NexGen: Study name (Tau Next Generation). Phase II/III study in DIAD conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU)

11

Comprehensive Pipeline that Supports AD Patient Journey
Pathology

Biomarker abnormality

MAX

Lecanemab*1
AHEAD 3-45 Study (Phase III)
A3
A45

Lecanemab
Clarity AD*2
LecanemabA

Subcutaneous (SC) formulationand maintenance dose regimen

DIAN-TU
Lecanemab + E2814 combination regimen study
Tau NexGen*3 Phase II/III
T

Anti-MTBR*4 tau antibody

E2814
Phase Ib/II (DIAD*5)

CSF Aβ42
Amyloid PET

TrkA*6 binding synapse regenerant
E2511
Phase ICSF tau

MRI + FDGPET

N

Anti-EphA4*7 antibody, synapse stabilizing

E2025
Phase I

Cognitive
impairment

Development based on human genetics
TREM2*8 function coordination for
dementia neuro-immnomodulator, Discovery

MIN
High-risk

Preclinical AD

MCI*9

Mild AD(I)

Moderate

SevereAll projects are investigational. Adopted from Lancet Neurol. 2013 Feb;12(2):207-16.
AT(I)N: Amyloid, Tau, (Neuro-Inflammation), Neurodegeneration*1: 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: Tau NexGen: Study name (Tau Next Generation). Phase II/III study in DIAD conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) *4: MTBR: microtubule binding region*5: DIAD: Dominantly inherited Alzheimer’s disease *6: Tropomyosin receptor kinase A *7: Erythropoietin-producing hepatocellular receptor A4 *8: Triggering receptor expressed on myeloid cells 2 *9: Mild cognitive impairment

12Topic 3
Pricing based onSocietal Value(Value-based pricing)13

Pricing based on Social Impact
Every business conduct should lead to generating social impact

Social impact should be measured quantitatively as yearly value(Use AD ACE Model*1 to calculate effects on medical costs, care costs and loss of productivity and so on)

We consider the following as stakeholders:“Public”: people living with the disease, their families, caregivers, HCPs, payers, governments“Private”: shareholders and employees
We place significance in providing value to every stakeholder

60% of the value created by lecanemab*2 will be returned to the “Public”,
and 40% will be allocated to “Private” as net sales in the US
Part of the value allocated to “Private” will be re-invested in future research anddevelopment to create new AD therapies and projects toward inclusive communities*1: AD Archimedes condition-event simulation model *2: Antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic. Collaboration with Biogen.

14Per Person Societal Value of Lecanemab*1 Estimated at 37,600 USD per Yearin the US by AD ACE Model
Initial Price per Year in the US Set at 26,500 USD per Patient (10 years)*2(QALY*4 gained x WTP threshold) + Cost offsets

Annual per person value delivered by Lecanemab*3 =37,600 USD per year per person =--Time on treatment(0.64 x 200,000 USD) + 7,415 USD
3.6

QALY = length of life x QOL, a measure of the value of health outcomes, 0.64 added by Lecanemab treatment compared to QALY 3.7 atthe beginning of treatment*5. As a result, the value of health outcomes would increase by approx. 17%. This may differ by country.
Willingness-to-pay (WTP) threshold: Per year WTP amount for one year in perfect health (1 QALY) gained from the societal perspective.
Conventionally, the WTP threshold is based on 1 to 3 times country’s per capita GDP. In the US, as a result, a WTP threshold of 50,000 USD to 150,000
USD is referenced as the cost-effectiveness threshold, but a higher WTP threshold is often considered to account for the gravity of conditions withgreater burden, and interventions that exhibit wider societal benefits, such as AD with substantial impacts on caregivers.
This may differ by country.
Cost offsets: total amount decreased due to Lecanemab treatment compared to SOC *6 (includes indirect costs of caregivers including family members).
This may differ by country.
Time on Treatment: Estimated mean duration of treatment. This may differ by country.

- Annual value (37,600 USD) x 10-year cumulative number of people treated = 10-year value (several tens of billion USD)
- 10-year value x 40% (net sales) / 10-year cumulative number of people treated = 10-year net price per person- 10-year net price includes initial biweekly dosing regimen and initiation of maintenance dosing regimen of once every 4 weeks.
Initial price was set as 26,500 USD*6 per year per person after such adjustments.

Yearly per-person value = 37,600 USD

Initial price per year = 26,500 USD per person*1: Antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic. Collaboration with Biogen *2: AD Archimedes condition-event simulation model*3: All figures are measured in present value (except for WTP threshold) *4: QALY: The quality-adjusted life year. QALY is an index that indicates the value of health outcomes. Combining life years and quality of life into a single
index number, 1 QALY equals 1 year in perfect health. *5: Compared to the SoC for patients with early AD who have confirmed presence of amyloid pathology. *6: Standard-of-care *7: Estimated annual price based on 10mg/kg
IV biweekly for average U.S. patient weight of 75kg based on Study 201 and Clarity AD

15

Impact of AD on Medical and Long-term Care Finances in Japan

Slowing of disease progression may
significantly reduce medical and long-term care costs
1,073.4

万Impact of AD on medical
costs in Japan in 2018(ten thousand yen)

2.5%

50

(billion yen, %)AD医療費
Medicalcosts for AD

Per person medical costs from AD
in Japan by disease stage

56

42
28

28

MCI
MCI
(CDR
(CDR 0.5)
0.5)

Mild AD
軽度認知症(CDR 1)(CDR
1)

Othersその他

42,321.5
0

97.5%

Moderate AD
中等度認知症(CDR 2)(CDR
2)(ten thousand yen)

Per person long-term care costs from AD
in Japan by disease stage

万Impact of AD on public long-termcare insurance finance in Japan
in 2018(billion yen, %)Severe AD
高度認知症(CDR3)
3)
(CDR

273

179

200

Public long-term care costs

AD公的介護費用
on AD
Othersその他

4,843.4
50.3%

4,783.2
49.7%

92

100

25
0

MCI
MCI
(CDR 0.5)(CDR 0.5)

Mild AD
軽度認知症(CDR 1)(CDR 1)Moderate AD
中等度認知症(CDR 2)(CDR 2)

Source: Estimates of National Medical Care Expenditure, Report on Long-term Care Insurance Service, Ministry of Health, Labour and Welfare.
S. Ikeda, M. Mimura, M. Ikeda, K .Wada-Isoe, M. Azuma, S. Inoue, K. Tomita “Economic Burden of Alzheimer’s Disease Dementia in Japan” Journal of Alzheimer’s Disease 81(2021)309-319

Severe AD
高度認知症(CDR 3)(CDR 3)16

Innovative Pricing Approach for Lecanemab in Japan*1

Aiming to develop highly transparent discussion by considering the case,when AD ACE Model is applied to Japanese society.
Preparation is underway to publish an article in collaboration withacademia regarding the social value in Japan,
in a peer-reviewed journal.
*2

The pricing of an innovative drug should be based on
evaluation of its social impact(Value-based pricing)This approach will drive innovation andbreak the stagnation of the pharmaceutical industry in Japan*1: Antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic. Collaboration with Biogen. *2: AD Archimedes condition-event simulation model

17

Topic 4
LEQEMBI Updates

18

Global Regulatory Submissions and Approval
The USJapan

EuropeChina

January 6, 2023

January 16, 2023

January 9, 2023

December 22, 2022

LEQEMBI*1 was approved
under AA pathway forthe treatment of early AD by
the FDA*2

Filed marketing
authorization application
as a treatment for early AD
to the PMDA*5

Submitted marketing
authorization application
as a treatment forearly AD to the EMA*6

Submitted data for
BLA to NMPA*7

Submitted supplemental
BLA*3 to the FDA for
full approval

March 3, 2023

January 26, 2023

February 27, 2023

Priority Review was grantedby the FDA

Priority Review was
granted by the PMDA

Priority Review was
granted by NMPAPDUFA*4 action date:July 6, 2023

The dates of submission/regulatory communication are based on local time
*1: Antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic. Collaboration with Biogen. Generic name is lecanemab.
*2: the U.S. Food and Drug Administration *3: Biologics License Application *4: Prescription Drug User Fee Act *5: Pharmaceuticals and Medical Devices Agency*6: European Medicines Agency *7: National Medical Products Administration

19

LEQEMBI*1

Movement in US Society to Improve Access
Proposal to Medicare and CMS*2February 6, 2023
A letter*3 to HHS*4 and CMS from a group of 74 Congress
Members
A group of 74 Congress Members led by Darin LaHood(Republican) and Paul Tonko (Democratic) sent
a letter asking reconsideration of Medicare coverage“We ask that CMS reconsider the CED*5 requirements for FDA*6 approved monoclonal antibodies targeting amyloid for thetreatment of Alzheimer’s disease. This overdue CMS action will
ensure Medicare beneficiaries living with MCI due to Alzheimer’s
disease and early stage Alzheimer’s disease have immediate
access to FDA-approved treatments if the patient and clinician
decide it is right for them.”
Excerpt from the letter:February 17, 2023
A letter*7 to HHS and CMS from a group of 20 senators
A group of 20 senators led by Susan Collins (Republican)
and Shelley Moore Capito (Republican) sent a letter
encouraging reconsideration of Medicare coverage“We encourage CMS to reconsider the CED requirements for
FDA- approved monoclonal antibodies targeting amyloid for thetreatment of Alzheimer’s disease. Our request reflects that ofthe patient community and is consistent with a request the
Alzheimer’s Association submitted to CMS on December 19, 2022.
That reconsideration request included a letter signed by morethan 200 Alzheimer’s disease researchers and experts
expressing their confidence in the lecanemab data, saying there
should be “no barriers” to accessing the drug if it is approved.”
Excerpt from the letter:

The letter was signed by 74 members of Congressincluding Darin LaHood and Paul Tonko

The letter was signed by 20 senators including Susan Collins andShelly Moore Capito*1: Antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic. Collaboration with Biogen. Generic name is lecanemab. *2: Center of Medicare and Medicaid Service*3: https://lahood.house.gov/_cache/files/6/7/67ba94cb-e102-42ad-a5cb-2f77f7fe996b/8E1A143749F295BA03179796D3B8B4F5.congressional-sign-on-letter-to-cms-on-alzheimer-s-ncd-2.6.23-2-.pdf*4: US Department of Health and Human Services *5: Coverage with evidence development *6: the U.S. Food and Drug Administration*7: https://www.collins.senate.gov/imo/media/doc/senate_alzheimers_letter_to_cms_and_hhs_-_02-17-23.pdf

20

Committed to Expand Access to LEQEMBI*1
upon Potential Full Approval
CMS*2 responded to Alzheimer’s Association (US) that it is not reconsidering the national coverage determination (NCD) forthe entire class of monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease, but also announced that
“if a monoclonal antibody directed against amyloid for the treatment of Alzheimer’s disease subsequently receives traditional FDA*3
approval, CMS will provide broader coverage using the framework we announced last year, under CED *4, on the same day.”*5
Eisai continues to have positive engagements with CMS and is communicating with CMS to fully answer the CED’s three questions.
Question 1: Does the antiamyloid mAb*6 meaningfully improve health outcomes (i.e., slow the decline of cognition and function) for patients inbroad community practice?
27% slowing of decline on the global cognitive (CDR-SB) and functional scale; slowed decline of activities of daily living by 37% (ADCS MCIADL); and the Lecanemab group experienced 49% less decline and 56% less decline on two QoL measures of EQ-5D-5L*7 and QOL-AD*8,
compared to placebo at 18 months. Clarity AD study was conducted in patients who had a broad range of comorbidities, comedications anda diverse racial and ethnic elderly patient population, that generally reflect that of the US Medicare population.
Question 2: Do benefits, and harms such as brain hemorrhage and edema, associated with use of the antiamyloid mAb, depend on characteristics
of patients, treating clinicians, and settings?
As for Benefits, consistent results at 18 months in all subgroups of disease stage, ApoE4*9 status, presence or absence of concomitant approved
AD symptomatic medication, and region. As for Harms, in core study, infusion-related reactions were most common adverse event across patient
subgroups. ARIA-E*10 and ARIA-H*11 were less common in ApoE4 non-carriers versus carriers, with higher frequency in ApoeE4 homozygous
carriers versus ApoE4 heterozygous carriers.
Question 3: How do the benefits and harms change over time?
Benefits increased or remained stable over time. Harms decreased after 3 months of administration, return to baseline risk.

Eisai believes that clinical study data of LEQEMBI can fully answer the three questions (High Level of Evidence)*1: Antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic. Collaboration with Biogen. Generic name is lecanemab. *2: Centers for Medicare & Medicaid Services*3: the U.S. Food and Drug Administration *4: Coverage with Evidence Development *5: https://www.cms.gov/newsroom/press-releases/cms-statement-response-alzheimers-associations-request-reconsider-final-national-coverage*6: monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease *7: EuroQol-5Dimention-5Level *8: Quality of Life-Alzheimer‘s Disease *9: ApoE4: Apolipoprotein ε4*10: Amyloid related imaging abnormalities-edema *11: Amyloid related imaging abnormalities-hemosiderin21Outlook for Amyloid Diagnosis
Amyloid PET and CSF diagnosis

Activate development ofblood-based biomarker

Maximum test capacity for Aβ confirmation in three years after launch and thereafter*1(10 thousand tests)

PET
95(10 thousand tests)

The US
100

Japan

110

100

24

16

20

CSF
50

70

70

70

10

CSF
0

0

2023

2024

2025

• Number of institutions that have capability ofamyloid PET diagnosis is currently approx. 580.
• Another approx. 150 institutions are expected toconsider adding amyloid PET diagnosis capacity
through 2025, based on reimbursement of amyloid
PET diagnosis and LEQEMBI*2.
• Reimbursement for amyloid PET/CSF diagnosis iscurrently restricted, but broad reimbursement is
expected to be realized within one year

8
6
2023

PET

10

11

2024

2025

• PET imaging site qualification and image reading
trainings by Japanese Society of Nuclear Medicine
are required to conduct amyloid PET diagnosis.
Approx. 51 sites are currently qualified as PET
imaging site.
• More institutions are expected to be qualified for the
PET imaging infrastructure in the next 3 years basedon availability of treatment and reimbursement ofamyloid PET diagnosis.
• Diagnosis capacity is expected to be secured basedon potential reimbursement of amyloid PET and
CSF diagnosis at the time of LEQEMBI launch.

Maximum amyloid PET and CSF test capacity is expected to be secured
along with LEQEMBI launch and reimbursement of amyloid confirmation tests

The US• C2N Diagnostics provides PrecivityAD® underLDT*3, and PrecivityAD2TM with increased accuracy
is expected to be provided under LDT in FY2023• Quest Diagnostics provides AD-DetectTM underLDT• C2N Diagnostics and Roche Diagnostics haveobtained BDD (Breakthrough Device Designation)from the FDA, which are expected to be introduced
as IVD*4.
• Sysmex Corporation is preparing LDT in the US

Japan• Shimadzu Corporation obtained medical device
approval for amyloid blood-based biomarker fromthe PMDA*5 in December 2020
• Sysmex Corporation obtained approval for amyloid
β blood-based biomarker as IVD from the PMDA
in December 2022
Blood-based biomarker is expected to contribute toscreening. Near-future availability as definitive
diagnosis test for amyloid β confirmation is increasing,supported by accumulated real world evidence.

*1: Outlook for test capacity is based on Eisai internal estimation*2: Antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic. Collaboration with Biogen. Generic name is lecanemab.
*3: Laboratory Developed Test *4: In-Vitro Diagnostics *5: Pharmaceuticals and Medical Devices Agency

22

Estimated Prevalence of Early AD and Potential Number
of Eligible People for AD-DMT toward 2032
*1

Transition of potential number of people
with Early AD by region*2

Transition of prevalence of early AD and potential
number of eligible people for AD-DMT (Global)

1.Prevalence of Early AD(MCI due to AD and Mild AD)

China

1. Prevalence of Early AD

243

Japan

2.4
243

5. Treated with AD-DMT

2.3
226

226

EMEA

2.1
210
1.8
175

(millions of people)

Asia /Latin America(100 millions of people)

210

Americas

189

1.9
189

87 (36%)

175

80
74

66
61

2. Diagnosed with Early AD at
medical institution
3.Amyloid β test

57

4. Amyloid β positive

Appx.
2.5
mil ppl5.Treated with
AD-DMT
2023

2025

2028

2030

Appx.
3.0
mil ppl

2032

62

70

82 (34%)75

66 (3%)

5

6

6

37

40

43

45 (19%)

35
17

18

20

21

23 (9%)

2023

2025

2028

2030
(

2032
) share by region

Prevalence in Asia/Latin America and China may Reach 70% of Global Total*1: Disease Modifying Treatment*2: Prevalence of early AD was estimated internally based on the number of people age 50-84 who potentially have early AD; eligible people for AD-DMT was estimated internally based on the prevalence of early AD with consideration for
medical environment and clinical diagnosis in each region. Data for the US, UK/France/Germany/Italy/Spain, China and Taiwan are internal estimation based on IQVIA survey data. Data for Japan are internal estimation based on“Study on Future Estimates of the Elderly Population with Dementia in Japan” (Ninomiya, 2014 MHLW Grant Grants System), “Prevalence of Dementia in Urban Areas and Measurements for Living Impairment in Dementia:
23
The Report for Scientific Research, (Asada, 2013 MHLW Grants System) Data for Canada and EMEA other than UK, France, Germany, Italy and Spain are internal estimation based on Decision Resources Group survey data.

Topic 5
Future Scenarios

24Revenue Simulation toward FY2032(Trillions of yen)

Revenue simulation by product*1

Others (including new potential products)
Lenvima
LEQEMBI◼ LEQEMBI*2• Access will potentially proceed in the US, Japan andEU, followed by China and Asia with wide prevalence,along with wider availability of blood-based biomarker
and others• Expect global revenue would reach 1 trillion yen level
in FY2030◼ Lenvima

1.0
1.0

0.0
0.0

• Lenvima is expected to expand centering in the US
with current indications and the revenue is expected toreach its peak in FY2025 through potential approvalsof new indications*3◼ New potential products• Anti-MTBR*4 tau antibody E2814*5 is expected to
expand contribution in dementia area
• New potential products in oncology including nextgeneration ADC*6 MORAb-202*7, CBP/β catenininhibitor E7386*8 are also expected to makecontribution*1: Figures shown are unofficial illustration of growth after adjustment of probability of success based on internal estimates. Official company guidance should be referred to the Consolidated Financial Report of each fiscal year.
FY2022 revenue is based on the forecast disclosed at the 3Q FY2022 Financial Results Presentation. *2: Antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic.
Collaboration with Biogen. Generic name is lecanemab. Revenue simulation of LEQEMBI is based on the provision under broader coverage by the CMS (Centers for Medicare & Medicaid Services)*3: Combination therapy of Lenvima with the anti-PD-1 antibody KEYTRUDA® is under joint development with Merck & Co., Inc., Rahway, N.J., U.S.A. *4: Microtubule binding region *5: Investigational. Discovered as part of
the research collaboration between Eisai and University College London *6: Antibody-drug conjugate *7: Investigational. Co-development with Bristol Myers Squibb. Generic name for MORAb-202 is farletuzumab ecteribulin.
*8: Investigational. Collaboration with PRISM BioLab25

Management’s Intention
Eisai is building an ecosystem (hhceco) for each disease,that supports and encompasses the people’s entire processfrom healthy state to high-risk, onset/treatment, follow-up/prognosis,
by playing the role of a producer
hhceco will be enhanced through repeatedmutual interactions between Data and Solutions
Eisai is a corporate entity that achieves social impact
through its business of creating Data and providing Solutions

26

The New Chapter for‘Eisai hhceco model’ has started by LEQEMBI

View of Manhattan from CEO’s Office at Eisai’s US Headquarters, Nutley, New Jersey (January 2023)

27

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).
28