FY2023(Fiscal Year Ended March 31, 2024)

Financial Results Presentation
Eisai Co., Ltd.
May 15, 2024

FY2023 Consolidated Statement of Income (IFRS)
Achieved increase in revenue in the pharmaceutical businessand operating profit, exceeding YoY and full-year forecast
while continuing proactive investment in LEQEMBIRevenue(Billions of yen)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
Expenses regarding shared profit of LEQEMBI (reimbursement)
Other SG&A expenses

Other income & expenses
Expenses in total*1
Operating profit
Profit for the year
Profit for the year (Attributable to owners of the parent)
ROE (%)Net DER*3 (times)
Ratio of equity attributable to owners of the parent (%)

FY2022
Results
Ratio (%)

744.4
684.4
60.0
177.8
566.6
173.0
243.7
358.3
121.3
-9.2
246.2
4.8
526.5
40.0
56.8 *2
55.4 *2
7.2*2

100.0
91.9
8.1
23.9
76.1
23.2
32.7
48.1
16.3
33.1
0.6
70.7
5.4
7.6
7.4

End of March 2023

-0.21
63.3

Results

741.8
691.5
50.3
155.3
586.4
169.0
230.4
374.4
141.6
-29.2
262.0
10.4
533.0
53.4
43.8
42.4

FY2023
Ratio (%)

100.0
93.2
6.8
20.9
79.1
22.8
31.1
50.5
19.1
35.3
1.4
71.9
7.2
5.9
5.7
5.1

YOY (%)

100
101
84
87
104
98
95
105
117
319
106
219
101
133
77
77

Forex
impact

27.3
23.7
25.8
10.7
15.0

24.9
0.9

End of March 2024

-0.19
62.8

FY2023 average exchange rates: 1 USD: 144.62 yen (+6.8% YoY), 1 EUR: 156.79 yen (+11.2% YoY), 1 GBP: 181.75 yen (+11.4% YoY), 1 RMB: 20.14 yen (+2.0% YoY)
*1: R&D expenses + SG&A expenses – Other income & expenses *2: Including the impact of repayment of paid-in capital from a consolidated U.S. subsidiary to the Company*3: "Net debt equity ratio" = ("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Breakdown of Revenue Migration

Achieved increase in revenue in the pharmaceutical businessdue to the growth of 3L: Lenvima, Dayvigo(Lemborexant) and LEQEMBI(Billions of yen)
Lenvima

FY2022revenue

744.4

DayvigoLeqembiPharmaceuticalbusiness+7.0

Pharmaceuticalbusiness

Halaven*1

Fycompa-9.7

Other business

FY2023
reveuneProducts
other than2
the above 5 items*

741.8

-2.7
100% YoY

One-time
income

249.6

142%
+12.4
41.8

29.4
0

4.3

297.6

+48.0 119%
YoY

YoY

+4.2

41.3

37.5 -3.8

37.1 -11.2

25.9

FY2022

284.4

327.0

-42.6

FY2023

Transfer of all future economic rights for elacestrant,
a selective estrogen receptor degrader+12.3
Sales milestone payment related to Lenvima (18.9B yen)
+2.2
Divestiture of rights of Myonal and Merislon in Japan+3.8
Divestiture of rights of Fycompa in U.S. (Q4 FY2022)-20.9
Divestiture of rights of Myonal and Merislon in Asia (Q3 FY2022)*1: Commercial rights for Fycompa in the U.S. were transferred to Catalyst Pharmaceuticals, Inc. in January 2023 *2: Partnership with AbbVie GK (Tokyo) for HUMIRA was ended due to expiration of the co-promotion agreement inJapan in June 2023

2

Breakdown of Operating Profit Migration
Ensuring double-digit profit growth
while continuing proactive investment in LEQEMBI(+) Positive factors for operating profit (-) Negative factors for operating profit
FY2022operating profit

40.0
Pharmaceuticalbusiness

Segment profit ofpharmaceuticalbusiness+18.0(Billions of yen)(+) Growth of Lenvima and Dayvigo(+) Decrease in U.S. Fycompa related expenses(+) Reversal of LEQEMBI related expenses received from Biogen(-) Increase in LEQEMBI related expenses
The ratio of segment profit of pharmaceutical business to revenue increased to 49.7%
from 47.6% in the previous year®

+4.0

R&D expenses
Group headquarters'
management
costs and otherexpenses-0.3

Segment profit ofother business

FY2023operating profit

-8.3
53.4

+13.4

133% YoY

R&D expenses(+) Decrease in ADUHELM related expenses(-) Increase in LEQEMBI related expenses(-) Regulatory milestone payment for Lenvima from Merck*1 (Q1 FY2022)

+6.1
-3.2

The ratio of R&D expenses to revenue decreased by 0.5 points YoY to 22.8% while
continuing investment in LEQEMBI
Group
headquarters'
management
costs and otherexpenses(+) Decrease in ADUHELM related expenses(+) Reduction of SG&A expenses and other expenses(-) Payment of shared profit of Lenvima to Merck

Other business(+) Transfer of all future economic rights for elacestrant,
a selective estrogen receptor degrader (Q1)(+) Sales milestone payment related to Lenvima (Q4)(-) Decrease in one-time income generated in the previous fiscal year®

Total investment in R&D and SG&A expenses
for LEQEMBI is at 110 billion yen level*2 as planned

Figures shown in breakdown are approximate*1: Merck & Co., Inc., Rahway, NJ, USA *2: Total amount of SG&A expenses and R&D expenses incurred by Eisai and Biogen

+8.9
-20.3

+12.3
+2.2

3

Eisai has paved the way as a pioneer in the treatment of Alzheimer’s
disease worldwide, and will continue to play this role:1997 by ARICEPT2023 by LEQEMBI
Aim for more treatments for more pathologies
4LEQEMBI FY2023 Revenue (Global)(Billions of yen)

Rapid progress in establishing diagnostic and treatment pathway
in the U.S. and Japan

FY2023 revenue: 4.26 billion yen

35
3.5

2.7 times greatercompared to theprevious quarter

30
3.0
25
2.5

2.83

20
2.0
15
1.5
1.06

10
1.0
0.55
0

0.07
Q1 FY2023

0.29
Q2 FY2023

Q3 FY2023

Q4 FY2023

5

LEQEMBI in the U.S.
“Toward a new phase”
Pathway establishment has seen a certain
level of progressTransitioning to prescription expansion phase

II

Strengthening Go-to-Market structure
6

LEQEMBI FY2023 Revenue (U.S.)(Billions of yen)

30
3.0
25
2.5
20
2.0

Rapid expansion of 2.3 times
compared to the previous
quarter due to progress inestablishment of diagnostic
and treatment pathway by IDN

2.44

15
1.5

1.04

10
1.0

(Unit: Number of vials)

Number of vials sold per week to medical institutions
The number of vials soldto medical institutions
6000
has been increasing at
an accelerated pace
5000
from Q4
7000

4000
3000

5
0.5

0.07
0

• The number of vials sold to medical institutions has been increasing at anaccelerated pace from Q4 FY2023.
• In particular for IDNs*, the establishment of pathway at top 100 IDNs has been
completed, and the number of vials sold increased by approximately
2.6 times in Q4 compared to Q3 FY2023.
• A high growth of approx. 2.2 times observed in the top 10 accounts over the
past three months through mid-April 2024, is contributing to revenue in the U.S.

0.29

Q1 FY2023 Q2 FY2023 Q3 FY2023 Q4 FY2023

2000
1000
May 4 -

Apr 20 -Apr 6 -

Mar 23 -Mar 9 -

Feb 24 -Feb 10 -Jan 27 -Jan 13 -Dec 30 -Dec 16 -Dec 2 -

Nov 18 -Nov 4 -

Oct 21 -Oct 7 -

0Establishment of foundation, including pathways at major IDNs and community hospitals has progressed.
Transitioning to prescription expansion phase.
* Integrated Delivery Network

7

The U.S.: Establishment of Foundation,
including the Pathway has Completed
Map of areas where pathways was established

AlaskaTop 100 target IDNs*1
97% of pathway established*2

Top target physicians*3
100% of pathway established*4
Target AICs*5
82% of pathway established*6

Hawaii

Areas where prescribing facilities with established pathway are locatedEstablished pathway and initiated LEQEMBI treatment at IDNs,
community hospitals, and AICs, in major areas across the U.S.
*1: Integrated Delivery Network *2: Total of either facilities with P&T approval or facilities which have started LEQEMBI prescription *3: Physicians who have experience in AD-DMT-related consultations and treatments, or who belong
to the top 100 IDNs *4: Total of either facilities which have started LEQEMBI prescription or facilities which have established pathway *5: AIC: Ambulatory infusion center *6: Estimated based on the number of facilities, which
8
LEQEMBI infusion is available

Strengthening the U.S. Go-to-Market Structure in FY2024
Significantly strengthening initiatives with NAS*1, ARM*2 and HSAE*3
as we transition to expansion phase•••

Through activities since traditional approval, awareness of LEQEMBI has increased rapidly, with current awarenessexceeding 90%*4
Many prescribing physicians have gone through a trial period and are now in the expansion phase, with some facilities
confirming over 200 cases of LEQEMBI treatment
Establishment of foundation including pathways at major IDNs*5 and community hospitals, has been largely completed
As we transition to prescription expansion phase, we aim to provide information tailored to different circumstances of facilities,
such as information regarding 1) LEQEMBI, 2) reimbursement and support for patients, and 3) system efficiency.
We will strengthen the Go-to-Market structure through close collaboration with stakeholders, centered on NAS, ARM, and HSAE.

Strengthen team structure with NAS, ARM, and HSAE
• Strengthen coverage of key accounts through 30% increase of NAS
personnel, including Biogen• Strengthen support related to reimbursement and patient through increaseof ARM’s FTE• Strengthen education on system efficiency through 100% increase of HSAE
personnel•••

Expand target IDNs to 150 to promote further adoption
Dramatically shorten the time from diagnosis to the start of treatment(a large IDN successfully shortened the time from 8 months to 2 months)
Strengthen patient support including introduction of the nearby AIC, provide
information on PAP*6 and support for reimbursement, in line with increasing
needs

While progressing from the pathway establishment to the prescription acquisition and expansion phase,
focus on further expanding LEQEMBI prescriptions and providing support for patient accessto prescribe LEQEMBI*1: NAS (Neurology Account Specialist) is a specialist in the neurology area, and is responsible for providing information regarding value of LEQEMBI *2: ARM (Access & Reimbursement Manager) mainly focuses on
supporting access at IDNs and provides information on reimbursement and insurance coverage, etc. *3: HSAE (Health System Account Executives) is responsible for providing information related to streamlining the processfrom diagnosis to the treatment *4: Results based on external survey *5: Integrated Delivery Network *6: PAP: Patient Assistance Program9

Establishing Omnichannel Marketing withRich Data across the Ecosystem
Data Lake
Digital promotion information
to healthcare professionals
Digital promotion information
to patients and consumers
Promotional activities
from field personnel to healthcare professionals

Real-time

data analysis

Omnichannel
promotion

Promotional activities
to major academic societies
AD-related diagnostic information
including amyloid test, etc.
Customer insights and segments

All results of activities areaccumulated in the Data Lake toimplement comprehensive
analysis by AI

Based on the results ofanalysis generated by AI,
implement Next Best Action
through optimal channels foreach customer:• Promotion by NAS• Peer to peer communication• Information provision via
social media

The rich information created in FY2023 is aggregated in the Data Lake and analyzed.
Omnichannel marketing will be in full fledge operation in FY2024.

10

Raise Awareness for
Earlier Visit to Physicians and Diagnosis
Direct To Patients (You Still Can Be With LEQEMBI)You Still Can Be
Social with LEQEMBI

Being seen engaging in everyday life,
often showing loved ones by theirside

You Still Can Be
Authentic with LEQEMBI

Wanting to see real people living realfulfilling lives

You Still Can Be
Relatable with LEQEMBI
Keeping the scenes grounded, so
patients can see themselves in theworld

You Still Can Be
Empowering with LEQEMBIShowing patients out living fulfilling
lives, counter to the normal perceptionsof AD

Aiming to directly raise awareness for earlier visit to physicians and diagnosis utilizing website, omnichannel/digital marketing,video/print/display advertisements in waiting rooms and examination rooms at hospitals/clinics, as well as multilingual brochures* Patients shown are not taking LEQEMBI

11

Enhancing the Value of LEQEMBIKey events expected in FY2024

Early AD:IV (initial treatment, 10 mg/kg biweekly):• Approval anticipated in multiple regions, including EU/UK
IV (maintenance treatment, 10 mg/kg monthly):• Submitted to US FDA with aim for earlier approval.
Initiated discussions with regulatory authorities
with aim for global submission.
SC-AI* (maintenance treatment, 360mg weekly):• Initiated rolling submission to US FDA under
Fast Track designation and aim to complete
rolling submission at earlier timing

Approved

Submitted

Initiatedrolling submission

IV Initial
treatment
10mg/kg
bi-weekly

IV Maintenancetreatment
10mg/kgmonthly

SC-AI maintenancetreatment
360mg
weeklySubmissions (planned)
SC-AI: initial andmaintenance treatment
weeklySC-AI (initial and maintenance treatment):• Initiated discussions with regulatory authorities withthe aim of earlier timing of the regulatory submission
Preclinical AD:• AHEAD 3-45 study (Phase III Study):
Aim to achieve enrollment of 1,400 patients* SC-AI: Subcutaneous formulation with auto injector

Subcutaneous formulation with auto injector
12

Reports of ARIA*1 after
LEQEMBI Launch in the U.S.
Reports of ARIA from real world clinical practice*2• Consistent with what was observed in the clinical trials as described in the US Package Insert• Most reports of ARIA in real-world clinical practice in the U.S. are non-serious, asymptomatic,
and occur early in treatment• Reported symptoms include headaches, vision changes, nausea, shortness of breath, and fatigue• Available information from real world clinical practice in the U.S. indicates that the instructions
concerning monitoring and performing of MRI for symptoms described in the US Package Insert,
are being followed by prescribers• Since the Accelerated Approval, Eisai has provided educational materials to improveunderstanding of ARIA through the “Understanding ARIA” website, which has been accessed byover 15,000 healthcare professionals*1: ARIA: Amyloid-related imaging abnormality *2: Generally, the number of spontaneous reports cannot be converted into an incidence rate that can be compared directly to a clinical trial rate of an adverse
event. This is because spontaneous reporting to the company and to health authorities, including the FDA, is not required and so it is expected that there will be cases that occur in the real-world setting that arenever reported. Also, serious/severe cases are more likely to be reported than nonserious/mild cases.

13

LEQEMBI in Japan

Establishment of the pathway has been fastII
Diagnosis and treatment for eligible patients areprogressing rapidly
14

Japan: Established Diagnosis and Treatment Pathway
at 600 Facilities within Four Months of Launch
Treatment initiated in all 47 prefectures in Japan(Number of facility)
600(Millions of yen)
600

Facilities
where LEQEMBI was delivered
納入施設数

Cumulative sales

Facilities which have completed establishment of
診断・治療パスウェイ構築完了施設数
diagnostic and treatment pathway

500

400

400

300

200

200

100

0

January
1月2024

February
2月

March
3月

April
4月

0
12月
1月 2024
December
2023 January

2月
February

3月
March

4月
April

A smooth start exceeding the target by supporting establishment of administration
environment in facilities that comply with the Optimal Usage Guidelines (OUG)

15

Efforts by Entire Japan TeamSpecialized Medical Reps (MRs)

The process of patient referral

Top KOL facilities
initiating LEQEMBI
treatment
Facilities initiating
LEQEMBI
treatment

The process of follow-up

Hospitals specializing indementia and primary care
physician’s clinics(follow-up/referral)

Primary care physicians who
provide dementia care(facilities to write referral)
Arrows indicate the movement of patient referral/follow-up

・hAC (hhc Area Coordinator: Eisai)
30% increase planned in FY2024
・MRs covering university hospitals and core hospitals (Eisai)
・AAE (Alzheimer Account Executive: 15 personnel from Biogen)・ Identify challenges and solutions through engagement with top KOLs
Penetration of treatment value based on evidence
・ Promote establishment of diagnosis and treatment pathway andimprove its efficiency
Initiate and promote plans to enhance intra-and inter-facility
collaborations

Regional cooperation MRs

・ Facilitate inter-facility collaboration in the region through collaboration withhAC/AAE
Promote patient referrals to facilities to initiate treatment with LEQEMBIActivities to raise disease awareness for MCI and encourage consultation at
physicianFacilitate follow-up facilities and promote establishment of inter-facility
collaboration
Development of a dementia ecosystem plans in the community
・ Establishment of pathway and penetration of the treatment value
Support establishment of efficient diagnostic flow to in-hospital healthcare
professionals

In FY2024, MRs specialized in dementia and MRs of Regional cooperation will lead to strengthen activities
to establish local dementia care collaboration and the diagnostic and treatment pathway,
and to penetrate LEQEMBI treatment

16

Leveraging History Made through Aricept[Nationwide meetings of specialists]
January 2024:
Japan Kick-Off Meeting (1,250 physicians participated)
April 2024:
The 25th Academic Symposium of the Japan Academy for
Alzheimer’s Disease• The first symposium held in 2000 was attended by
290 people, and 1,300 people participated either
in-person or online in this year’s 25th symposium.
The accumulate number of participants is over
30,000. The number of members has grown toapproximately 4,800.
• There was lively discussion on topics such as early
diagnosis and the ideal form of clinical collaboration
for LEQEMBI treatment. The discussion
garnered strong, enthusiastic responses fromphysicians.
• The sessions also featured speakers who arepatients with dementia, as well as discussions onachieving a dementia-inclusive society are held every time.

[Gatherings at each medical region]

Conduct various gatherings and study sessions incollaboration with healthcare professionals to solve
diverse issues of medical regions
・ Sessions of physicians promoting the penetration of
LEQEMBI treatment in the region
・ Sessions for promoting the establishment of dementia
treatment collaboration in medical regions
・ Sessions aiming to connect initial LEQEMBI
treatment facilities and follow-up facilities
・ Sessions to improve dementia diagnostic method
・ Sessions to share experience of LEQEMBI treatment
and issues
・ Sessions to introduce/share issues of government andlocal governments on dementia to other areas’ local
government and others

Over 200 meetings and study
sessions have been held
nationwide since launch

Accelerating the penetration of LEQEMBI treatment through the latest diagnostic and treatment
technologies, as well as the strong relationships of trust built with dementia specialists

17Promoting Efficient Omnichannel Marketing

Interview

hAC
AAE

*1

• Based on integrated analysis data using AI, the next optimal
information and actions to be conveyed are recommended to
MRs
Examples:• Materials and data points to introduce next
• Topics to cover in future seminars• Content to discuss during interviews and the suitablepeople to accompany• Information on live seminars and academic conferencesthat fulfill needs

Medical rep(MR)
Owned website
Email/
newsletter*2

3rd party*3

KAM

Healthcare professionals involved in
LEQEMBI treatment

ILS*5

ProductmanagerMRs dedicatedto digitalmarketingMarketingspecialist

Accumulate information
obtained through allactivities in the Data Lakeand conduct integrated
analysis

Meeting*4

MSL

Academicsociety*1: hhc Area Coordinator*2: Alzheimer Account Executive*3: Key Account Manager*4: Medical Science Liaison*5: Internet Live Seminar• Concurrently, information that meets the needs of healthcare
professionals are provided through channels that do not involve
MRs
Example:Information on LEQEMBI and dementia care are provided
from 3rd party, e-mail/newsletter and owned website• By repeating this cycle of activities, the actions with the greatest
needs can be implemented in the shortest time possible, and it
may lead to strengthening relationships with healthcare
professionals and potentially the increase of LEQEMBI
prescriptions

Leverage the knowledge obtained through various on-site activities to efficiently provide
highly-needed information to healthcare professionals.
Aiming to drive penetration of the value of LEQEMBI and expansion of prescription.

18

LEQEMBI in China(Launch planned in July)

Aiming to establish a pathway that differsfrom Japan and the U.S.

II

Leverage industry collaboration anddigital technology
19Pathway Establishment through
Online-Merge-Offline Strategy
Diagnosis

Screening

Offline: hospital/ ICL*1 / DTP pharmacy*2/ infusion center“Benefit Card” (Insurance product)• Increase awareness of disease and
LEQEMBI•
Drive pre-screening
Commercial• Recommend consultation for people
insurance
at high risk
• Reduce economic burden of patients Potential patientsare directed toPlan to issue “Benefit Card” from June
hospitals forfurther diagnosis
Private• Cognitive function test
health• APOE4 test
• MRI
checkupStreamlined diagnosis:

Establish diagnosis model mainly
using BBBM*3
Plan to promote “Quick-start model*4“ fromQ2 FY2024

Wide access for BBBM tests:
Establish diagnosis network with
IVD*5 companies and top ICLs

Drive patients to offline
diagnosis and treatment

Private• Disease awareness and education
nursing home • Early screening

Diverse options for LEQEMBI
administration:
Public hospital/Cooperative infusion sitenear DTP pharmacy/Private hospital

ARIA monitoring:

Online reminder from Yin Fa Tong

Motivate patients to utilize Yin
Fa Tong during patient journey

Yin Fa Tong*6 (Online health platform)
Memory Map

Potential patients will bedirected to Yin Fa Tong

Treatment• Recommendation for
hospital and specialist
doctors• Aβ test sites• Infusion centers

Patient Care Package• Drive early registrationand diagnosis• Provide online
consultation andaccompany service

Memory Care Center(Long term management)• Online consultation• Follow-up and reminders of
ARIA monitoring• Cognitive training• Communication between
patients*1: Independent clinical laboratory*2: Direct-to-patient pharmacy*3: Blood based biomarker*4: Stratify patients by assessing their MMSE (Mini-Mental State Examination) score, blood test, APOE4 test, and Age. If the patient has high risk, prompt initiation LEQEMBI treatment will be considered*5: In vitro diagnostics *6: Online business by Jingyi Weixiang (Shanghai) Health Industry Development Limited Company, a joint venture of JD Health and Eisai China Holdings Ltd.

20

LEQEMBI FY2024 Revenue Forecast (Global)■ The U.S.
■ Japan■ Others

10.0
billionyen
4.3
billionyen

3.0
billionyen

56.5
billionyen
43.5
billion yen

FY2023 result

FY2024 forecast
21Value of LEQEMBI- LEQEMBI possesses potentially one of the most extensive treatment dataset on Early Alzheimer’s Disease (EAD)in the world. It is demonstrating a consistent and distinct efficacy and safety profile across a broader population of
EAD, rather than specific subsets of EAD, and in particular, the patients’ number of mild cognitive impairment(MCI) is unmatched*1. Significant treatment data from low-tau group*2 suggested potential greater treatment benefit
when treatment is initiated at the early stage within MCI. In addition, long-term treatment study is showing
abundant results, and continued efficacy was shown at 30-months treatment*3. This highlights the importance ofcontinuous treatment in EAD, a progressive neurodegenerative disease*4. The data from LEQEMBI indicated thatearly-start and long-term treatment bring greater benefit for EAD patients.
- The improvement in dosage and administration is important for continuing treatment, and the regulatory filing forless frequent monthly dosing of IV for maintenance treatment has been submitted. A rolling submission for SC-AI
filing has also initiated under Fast Track designation. The importance in administration at home or nursing homeusing SC-AI is significant, in the context of reducing burden of healthcare professionals as well as visits to Site ofCare for IV infusion.
- When Aricept was launched in 1997, treatment was initiated at a stage of mild AD. In 2023, LEQEMBI can treat
MCI, so the treatment stage became earlier. Furthermore, once AHEAD3-45 with targeting Preclinical AD
population succeeds, treatment initiation timing may become even earlier with potentially further expanding
clinical benefit.
- The status of ARIA seems to be within the range as described in the clinical trials, which indicates safety can beappropriately monitored and managed as per the Package Insert.
*1: Number of MCI patients in Clarity AD: 1,072 *2: Tau PET substudy presented at Late Breaking Symposium of 16th annual Clinical Trials on Alzheimer’s Disease (CTAD) conference (Boston, US, October 24-27, 2023)
Symposium 4 “Lecanemab for Early Alzheimer’s Disease: Long-Term Outcomes, Predictive Biomarkers and Novel Subcutaneous Administration” *3: 24-month treatment data; Efficacy in long-term treatment (OLE) and data at 24
months treatment: Presented at Late Breaking Symposium 4 “Lecanemab for Early Alzheimer’s Disease: Long-Term Outcomes, Predictive Biomarkers and Novel Subcutaneous Administration” at the 16th annual Clinical Trials on
Alzheimer’s Disease (CTAD) conference (Boston, US, October 24-27, 2023, 30-months treatment data; Data will be presented at AAIC in Philadelphia, US, July 28-August 1, 2024 *4: Study 201 OLE Gap period, McDade et al.
Alzheimer’s Research & Therapy (2022) 14:191

22

Lenvima

Contribute to patients as a backbone therapy in the mid- to-long term
• Eisai entered into a settlement agreement with “SUN Pharma*1” in the U.S. to resolve litigation
regarding Lenvima high purity patents(An important step forward toward continuing to contribute to patients in the mid- to long-term)• Aiming to expand indications in upper gastrointestinal cancers where further enhancement oftreatment effects is desired, through Phase III studies: LEAP-012 (hepatocellular carcinoma in
combination with TACE*2: LPI in January 2023*3), LEAP-014 (esophageal carcinoma: enrollment
ongoing), and LEAP-015 (gastric cancer: LPI in March 2023)• Aiming to achieve sustainable growth in the renal cell carcinoma area through Phase III studies fornovel combination treatment, LITESPARK -011 and 012*4 (combination with HIF-2α*5 inhibitors:
LPI in August 2023 and LPI in March 2024)

Aiming to contribute to patients in the mid - to long-term,
as well as to continue to generate 300 billion yen level revenue*1: SUN Pharmaceutical Industries Ltd. and SUN Pharmaceutical Industries Inc. *2: Transcatheter Arterial Chemo Embolization *3: Last Patient In *4: LITESPARK is a development program led by Merck for renal cell
carcinoma. The LITESPARK-011 study is for second-line treatment, and the LITESPARK-012 study is for first-line treatment. https://www.merck.com/news/fda-accepts-for-priority-review-mercks-supplemental-new-drugapplication-for-welireg-belzutifan-in-certain-previously-treated-patients-with-advanced-renal-cell-carcinoma-rcc/ *5: Hypoxia-inducible factor-2α23

3L: Lenvima, LEQEMBI and Dayvigo (Lemborexant)
FY2024 Revenue Forecast(Billions of yen)
100%
1328%
124%
297.6

296.5
56.5

3L revenue

52.0
41.8

405.0 B yen
118% YoY
4.3
FY2023
resultFY2024
forecast

Continue to generate
300 billion yen level revenue

FY2023
resultFY2024
forecast

Prescription expansion
phase has initiatedFY2023
resultFY2024
forecast(lemborexant)

Aiming for continuous
growth in Japan

Aiming to achieve revenue of 724.5 billion yen in FY2024
in the pharmaceutical business through the growth of the 3L

24

Capital Strategy and Shareholder Returns

Acquisition of own shares and cancellation of treasury shareswere resolved by the Board of Directors (May 15, 2024)
Overview of acquisition of own shares• Total number of shares to be acquired: 6.5 million shares (maximum)(Ratio to total number of issued shares*1: 2.3%)• Total amount of acquisition cost:
30.0 billion yen (maximum)• Period of acquisition:
May 16, 2024 to November 15, 2024
Financial strategy• From mid- to long-term ROE management perspective, acquisition of own shares was decided,by taking into consideration a balance between future financial performance and shareholder
returns, and others• Progressing our shareholder return policy centered on dividends to the combination of stabledividends and flexible acquisition of own shares• We aim to improve further capital efficiency and financial KPIs (ROE, PBR, EPS, DOE, etc.) toincrease shareholder value• After acquisition of own shares, investment capacity for future growth opportunities and financial
soundness are maintained*1: Excluding treasury shares

25

FY2024 Consolidated Financial Forecast (IFRS)

Focus on the 3L to achieve increase in revenue and profits(Billions of yen, %)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)FY2023Results
Ratio (%)

Forecast

FY2024
Ratio (%)

YOY

741.8
155.3
586.4
169.0
374.4
10.4
53.4
43.8

100.0
20.9
79.1
22.8
50.5
1.4
7.2
5.9

754.0
170.5
583.5
167.5
382.5
20.0
53.5
44.5

100.0
22.6
77.4
22.2
50.7
2.7
7.1
5.9

102
110
100
99
102
192
100
102

42.2

5.7

43.0

5.7

101

147.9
5.1
5.5
160

152.5
5.2
5.5
160

Dividend payment is subject to annual resolution by Eisai’s Board of Directors.
FY2023 average exchange rates:
1 USD: 144.62 yen, 1 EUR: 156.79 yen, 1 GBP: 181.75 yen, 1 RMB: 20.14 yen
FY2024 expected average exchange rates:
1 USD: 145.00 yen, 1 EUR: 155.00 yen, 1 GBP: 180.00 yen, 1 RMB: 20.40 yen

26

Reference Data

27

Consolidated Statement of Income
FY2022（Billions of yen）

April - March
Results

FY2023
Ratio (%)

April - March
Results

Ratio (%)

YOY (%)FY2024

Forecast(announced in
November)

YOY (%)

Progress toforecast (%)

Forecast

YOY (%)

Revenue

744.4

100.0

741.8

100.0

100

741.0

100

100.1

754.0

102

Pharmaceutical business

684.4

91.9

691.5

93.2

101

690.0

101

100.2

724.5

105

Other business

60.0

8.1

50.3

6.8

84

51.0

85

98.6

29.5

59

Cost of sales

177.8

23.9

155.3

20.9

87

154.5

87

100.5

170.5

110

Gross profit

566.6

76.1

586.4

79.1

104

586.5

104

100.0

583.5

100

Expenses in total*1

526.5

70.7

533.0

71.9

101

ー

ー

ー

ー

ー

R&D expenses

173.0

23.2

169.0

22.8

98

166.0

96

101.8

167.5

99

SG&A expenses

358.3

48.1

374.4

50.5

105

374.0

104

100.1

382.5

102

Other income & expenses

4.8

0.6

10.4

1.4

219

4.5

94

231.8

20.0

192

Operating profit

40.0

5.4

53.4

7.2

133

51.0

127

104.7

53.5

100

Profit for the year

56.8

7.6

43.8

5.9

77

43.0

76

101.8

44.5

102

55.4

7.4

42.4

5.7

77

41.5

75

102.2

43.0

101

Profit for the year

(Attributable to owners of the parent)

FY2023 average exchange rates: 1 USD:144.62 yen (+6.8% YoY), 1 EUR: 156.79 yen (+11.2% YoY), 1 GBP: 181.75 yen (+11.4% YoY), 1 RMB: 20.14 yen (+2.0% YoY)
FY2024 expected average exchange rates: 1 USD: 145.00 yen, 1 EUR: 155.00 yen, 1 GBP: 180.00 yen, 1 RMB: 20.40 yen*1: R&D expenses + SG&A expenses – Other income & expenses

28

Segment Revenue
FY2022（Billions of yen）

April - March
Results

FY2023
Ratio (%)

April - March
Results

Ratio (%)

YOY (%)FY2024

Forecast(announced in
November)

YOY (%)

Progress toforecast (%)

Forecast

YOY (%)

684.4

91.9

691.5

93.2

101

690.0

101

100.2

724.5

105

Japan

238.9

32.1

216.9

29.2

91

224.5

94

96.6

218.0

100

Americas*1

212.7

28.6

232.4

31.3

109

229.0

108

101.5

266.5

115

China

110.8

14.9

111.9

15.1

101

109.5

99

102.2

109.0

97

EMEA*2

72.2

9.7

76.0

10.2

105

74.0

103

102.7

74.5

98

Asia and Latin America*3

49.8

6.7

54.2

7.3

109

53.0

106

102.3

56.5

104

Other business*4

60.0

8.1

50.3

6.8

84

51.0

85

98.6

29.5

59

Consolidated revenue

744.4

100.0

741.8

100.0

100

741.0

100

100.1

754.0

102

Pharmaceutical business total

Revenue to external customers.
Eisai Group's business is comprised of pharmaceutical business and other business. The pharmaceutical business is organized into the following five reporting segments in this report: Japan, Americas (North America),
China, EMEA (Europe, the Middle East, Africa, Russia and Oceania), and Asia and Latin America (primarily South Korea, Taiwan, India, ASEAN, Central and South America). In line with the reorganization of Japanbusiness in FY2023, OTC and others has been integrated into Japan pharmaceutical business. This change has been reflected in Segment Information for April-March 2022.
*1: North America *2: Europe, the Middle East, Africa, Russia and Oceania *3: Primarily South Korea, Taiwan, India, ASEAN, Central and South America*4: Other business mainly includes the license revenue and pharmaceutical ingredient business of the parent company

29

Segment Profit
FY2022（Billions of yen）

April - March
Results

FY2023

Ratio (%)

% ofrevenue

April - March
Results

Ratio (%)

% ofrevenue

YOY (%)

325.6

87.0

47.6

343.6

89.5

49.7

106

Japan

72.9

19.5

30.5

72.8

19.0

33.5

100

Americas*1

133.4

35.7

62.7

147.2

38.4

63.3

110

China

55.6

14.9

50.2

57.7

15.0

51.5

104

EMEA*2

41.6

11.1

57.6

42.0

10.9

55.2

101

Asia and Latin America*3

22.1

5.9

44.4

24.0

6.2

44.2

108

Other business*4

48.5

13.0

80.8

40.2

10.5

79.9

83

Segment total

374.1

100.0

50.3

383.8

100.0

51.7

103

R&D expenses and Group headquarters’
management costs and other expenses*5-334.0ーー-330.4

ー

ー

99

40.0

ー

5.4

53.4

ー

7.2

133

Pharmaceutical business total

Consolidated operating profit*1: North America *2: Europe, the Middle East, Africa, Russia and Oceania *3: Primarily South Korea, Taiwan, India, ASEAN, Central and South America*4: Other business mainly includes the license revenue and 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 121.3B yen in April 2022-March 2023 and 141.6B yen in April
2023-March 2024.

30

Global Revenue from Major Products* Commercial rights for Fycompa in the U.S. were transferred to Catalyst Pharmaceuticals, Inc. on January 25, 2023

31

Performance ofJapan Pharmaceutical Business*1: The development and marketing agreement for Humira in Japan with AbbVie GK was expired in June 2023.
*2: EA Pharma product *3: Includes revenue of triple formulation Helicobacter pylori eradication packs (Rabecure Pack 400/800 and Rabefine Pack)

32

Performance ofAmericas* Pharmaceutical Business* North America

33Performance ofChina Pharmaceutical Business

34

Performance of
EMEA* Pharmaceutical Business
FY2022（Billions of yen）
[ ] based on local currency

April - March
Results

FY2023
Ratio (%)

April - March
Results

Ratio (%)

FY2024
Forecast(announced in
November)

YOY (%)YOY (%)

Progress toforecast (%)

Forecast

YOY (%)

72.2

100.0

76.0

100.0

105

[100]

74.0

103

102.7

74.5

98

Lenvima/Kisplyx

30.9

42.9

38.2

50.2

123

[119]

37.0

120

103.2

39.5

103

Fycompa

11.7

16.3

12.8

16.9

109

[102]

12.5

107

102.7

13.5

105

Halaven

13.6

18.9

11.7

15.4

86

[82]

12.0

88

97.5

ー

ー

Inovelon

3.1

4.3

3.4

4.4

109

[100]

ー

ー

ー

ー

ー

Segment profit

41.6

57.6

42.0

55.2

101

[98]

ー

ー

ー

ー

ー

Revenue* Europe, the Middle East, Africa, Russia and Oceania

35Performance of Asia and Latin America*
Pharmaceutical Business
FY2022（Billions of yen）
[ ] based on local currency

April - March
Results

FY2023
Ratio (%)

April - March
Results

Ratio (%)

FY2024
Forecast(announced in
November)

YOY (%)YOY (%)

Progress toforecast (%)

Forecast

YOY (%)

Revenue

49.8

100.0

54.2

100.0

109

[103]

53.0

106

102.3

56.5

104

Aricept

13.0

26.1

13.5

24.9

104

[99]

ー

ー

ー

ー

ー

Lenvima

11.1

22.3

13.0

23.9

117

[109]

12.0

108

108.2

14.0

108

Pariet

4.5

9.0

5.0

9.3

112

[106]

ー

ー

ー

ー

ー

Methycobal

3.9

7.9

4.4

8.0

111

[106]

ー

ー

ー

ー

ー

Halaven

3.3

6.6

3.5

6.4

105

[98]

3.5

107

98.8

ー

ー

Fycompa

1.7

3.5

1.9

3.5

108

[104]

2.0

115

94.6

2.0

106

Segment profit

22.1

44.4

24.0

44.2

108

[101]

ー

ー

ー

ー

ー

* Primarily South Korea, Taiwan, India, ASEAN, Central and South America

36Strong Balance Sheet to Achieve
Investment for Growth and Stable Dividends
Net cash*1

End of March
2024

168.7B yen
-0.19

+0.01

875.6B yen+75.7B yen

Net DER*2 (Times)
Shareholders’ equity(Attributable to owners of the parent)

Ratio of equity attributable toowners of the parent (Equity to total assets)
Continue tosecure net cash position

Difference fromend of March 2023
+3.3B yen

62.8%
Achieveinvestment for
growth and stabledividends-0.5%

Adhere to the KPIs for
optimal capital structure
Net DER-0.3 to +0.3

Ratio of equity attributable toowners of the parent

60% level

Dividends within the range offree cash flow on multi-year basis

Aim to maintain investment for growth and stable dividends based on financial integrity
Aim to maximize medium- to long-term shareholder value through growth centered on LEQEMBIDividend payment is subject to annual resolution by Eisai’s Board of Directors.
*1: Net cash = “Cash and securities” (“Cash and cash equivalents” + “Time deposits exceeding three months” + “Investment securities held by the parent company”) - “Interest-bearing debt” (“Corporate bonds and loans”)*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 company”) / “Equity attributableto owners of the parent”

37Consolidated Revenue Simulation toward FY2032
1st Phase: FY2022 - 2026

Establish and develop diagnosis and treatment
pathway of LEQEMBI worldwide
・Revenue: 1 trillion-yen level in FY2026
・Operating profit margin: High single digits to around 10%
・ROE: Secure a 10-year average at 8.0% or more

(Trillions of yen)

2.0

Other brands(Lenvima, Dayvigo, BB-1701, E7386, MORAb-202, E2814, E2086 etc.)

2nd Phase: FY2027 - 2032

Significant advancement is expected in AD treatment throughsimplified diagnosis and treatment pathway

FY2032 ・Revenue: Over 2 trillion yen

・Operating profit margin: 20% level
・ROE: 25% level, 10-year average at 15% level
・DOE: 15% level- Expansion of new indications and potential later datefor LOE for Lenvima are assumed

LEQEMBI (Preclinical AD)
LEQEMBI (Early AD)

1.0

0.0
Consolidated revenue simulation shown is 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. FY2023 revenue is based on the forecast disclosed at the 3Q FY2023 Financial Results Presentation.
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. Investigational BB1701: Antibody drug conjugate (ADC)with anti-HER2 antibody and eribulin. Joint development with Bliss Biopharmaceutical (Hangzhou) Co., Ltd. Investigational E7386: CBP/β-catenin inhibitor. Collaboration with PRISM BioLab. Investigational MORAb-202/FZEC: ADC using
Eisai’s proprietary antibodies farletuzumab and eribulin. Co-development with Bristol Myers Squibb. Investigational E2814: Anti-MTBR tau antibody. Discovered as part of the research collaboration between Eisai and University College
London. Investigational E2086: Orexin 2 receptor agonist

38

Overview of Anti-Aβ Antibody Clinical Trial Designs (Phase II & Beyond)Drug(Sponsor)

Study name (phase),
NCT number

lecanemab*1(Eisai, Biogen)

Clarity AD(Phase III)
NCT03887455

lecanemab(Eisai, Biogen, ACTC, NIA)AHEAD 3-45
(Phase III)
NCT04468659

E2814*4/lecanemab(Washington University Schoolof Medicine, Eisai)

Target population(Enrollment number)

Dose

Early AD
(Prodromal to mild) (1800)

donanemab,
placebo

TRAILBLAZER-ALZ 3(Phase III)
NCT05026866

Preclinical AD(2600)

donanemab,
placebo

TRAILBLAZER-ALZ 5(Phase III)
NCT05508789

Early AD (Prodromal to mild)(1500)

donanemab
placebo

TRAILBLAZER-ALZ 6(Phase IIIb)
NCT05738486

Early AD (800)

donanemab(Dose Level 1, 2, 3, 4)
Placebo

TRAILRUNNER-ALZ 1(Phase III)
NCT05463731

Early AD （600）remternetug (IV)remternetug (SC)PlaceboPhase I/II
NCT04639050

Prodromal/ mild to moderate
AD (285)

trontinemab (IV)
Placebo

DIAN-TU(Phase II/III)
NCT05269394
TRAILBLAZER-ALZ(Phase II)
NCT03367403
TRAILBLAZER-ALZ 2(Phase III)
NCT04437511

donanemab(Eli Lilly)

remternetug
LY3372993(Eli Lilly)
trontinemab
RO7126209

Brainshuttle Aβ antibody(Roche)Inclusion criteria (excerpt)

Primary endpoints (for core study)

Core study: MCI due to AD, mild AD-D (NIA-AA),
Core study: 10mg/kg biweekly,
CDR: 0.5-1, CDR memory box≧0.5, amyloid positive, MMSE≧22,
CDR-SB
Early AD
PlaceboWMS-IV LMII: ≧1 SD below age-adjusted mean
OLE: 10 mg/kg biweekly (IV)
(18 months)(1906*2,3)
SC sub-study: All participants must have an amyloid PET scan
720mg weekly (SC sub-study)
within 4 weeks before starting SC lecanemab
CDR: 0, MMSE≧27, WMS-R LM II≧6
A3: Amyloid PET SUVr (216 weeks)
5mg/kg + 10mg/kg,
A3: Intermediate levels of brain amyloid pathology
A45: Preclinical Alzheimer Cognitive
Preclinical AD (1400)
Placebo
A45: Elevated brain amyloid pathology
Composite 5 (PACC 5) (216 weeks)
Individuals
who
know
they
have
an
AD-causing
mutationandare
E2814,
DIAD*5, cognitively normal orwithin -10 to +10 years of the predicted or actual age of cognitive Change in tau PET from week 24 to 104 (interimwith MCI or mild dementia
lecanemab,
symptom onset. Cognitively normal or with mild cognitive
analysis), and week 208 (final analysis)(168)
matching placebo (E2814)
impairment or mild dementia, CDR 0-1 (inclusive)
18
700mg Q4W x3,
MMSE: 20-28, meet F flortaucipir PET scan criteria
Integrated Alzheimer‘s Disease Rating Scale
Prodromal to mild AD
181400mg Q4W up to 72W,
and F florbetapir PET scan (central read) criteria(iADRS) (18 months)(272)
placebo
MMSE: 20-28, meet

18

18

F flortaucipir and F florbetapir PET scan(central read) criteria

Telephone Interview for Cognitive Status-modified (TICS-M) scorereflective of intact cognitive functioning. Has a phosphorylated tau(p-tau) result consistent with the presence of amyloid and early-tau
pathology
MMSE: 20-28, meet

18

18

F flortaucipir and F florbetapir PET scan(central read) criteria

iADRS(76 weeks)Time to clinical progression by
Clinical Dementia Rating-Global Score(CDR-GS) (up to 182 weeks)iADRS (76 weeks)

Percentage of Participants with any occurrenceof Amyloid-Related Imaging AbnormalityEdema/Effusion (ARIA-E)(24 weeks)
Percentage of participants who reach amyloid
MMSE 20-28, has p-tau and amyloid PET scan results consistentplaque clearance on amyloid PET scanwith the presence of amyloid pathology(52 weeks)
Percentage of participants with adverse events.
Probable mild to moderate AD dementia or prodromal AD (NIA-AA), (Part 1,2: up to 56 weeks, Part 3: up to 52 weeks,
MMSE: 18 - 28, CDR-GS: 0.5, 1, or 2, Positive amyloid PET scanPart 4: up to 129 weeks)(Part 1, 2 and 3)
Change from baseline in brain amyloid load as
Completed the treatment period in Part 1, 2, or 3 (Part 4)
measured by amyloid PET scan(Part 3: up to 24 weeks)
MMSE: 20-28, have an amyloid PET scan result from central read,consistent with the presence of amyloid pathology

Study design overview for Phase II and beyond in this chart was edited by Eisai based on ClinicalTrials.gov as of May 7, 2024. All projects are investigational except for lecanemab in the U.S. and Japan.
OLE: Open label extension IV: intravenous administration SC: subcutaneous administration *1: Investigational antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic. Approved for early AD
indication for lecanemab in the U.S., Japan and China *2: Includes 111 subjects in China *3: SC sub-study planned to enroll an additional 40 de novo participants (those that did not participate in the core study) with early AD *4: Anti-MTBR tau antibody.
Discovered as part of the research collaboration between Eisai and University College London. *5: Dominantly Inherited Alzheimer's Disease39

Pipeline that Supports AD Patient Journey
Accelerating development of subsequent AD projects,
including anti-MTBR*1 tau antibody E2814*2
Target indication

ATN (I)*3 comprehensive AD pipeline

Nonclinical

Phase I

(Anti-Aβ*5 protofibrils antibody)

Early AD (China)

January 2024: Received full approval

Early AD (EU)January 2023: Filed MAA*6

Preclinical AD*7

Phase III ongoing

IV maintenance treatment

March 2024: Filed sBLA*8

SC-AI*9 maintenance treatment

T
N

E2814

(Anti-MTBR tau antibody)

AD

E2025

AD

TREM2*15 function coordinationAD

CD33 Modulator*16

AD(TrkA*12 integrated synapse regenerant)(Anti-EphA4*14 antibody)(I)

Dementia neuro-immunomodulator

Anticipate EMA
output in 1H FY24

Phase II/III ongoing

Combination regimen with lecanemab

E2511

Approval, launch

May 2024: Initiated BLA rolling submission under Fast Track

Tau NexGen*10 for DIAD*11
Study 103 in DIAD

Submission

September 2023: Received full approval, December 2023: Launch

Early AD (Japan)

Lecanemab*4

Phase III

July 2023: Received full approval and launched

Early AD full approval (U.S.)

A

Phase II

Phase Ib/II ongoing

Target engagement confirmed in DIAD using newly
developed biomarker (MTBR-tau243)

Phase I (MAD*13) ongoing
Phase I ongoing

Above projects are investigational.
*1: Microtubule binding region *2: Discovered as part of the research collaboration between Eisai and University College London *3: ATN(I): Amyloid, Tau, Neurodegeneration (Neuro-Inflammation)*4: Antibody for AD produced as the result of a strategic research alliance between Eisai and BioArctic. Collaboration with Biogen. Product name is LEQEMBI in the U.S *5: Amyloid beta *6: Marketing Authorization Application*7: Collaboration with ACTC (Alzheimer’s Clinical Trials Consortium) *8: Supplemental Biologics License Application *9: Subcutaneous injection formulation with auto-injector *10: Study in DIAD conducted by Dominantly Inherited
Alzheimer Network Trials Unit (DIAN-TU) *11: DIAD: Dominantly inherited Alzheimer’s disease *12: tropomyosin receptor kinase A *13: Multiple Ascending Dose *14: Erythropoietin-producing hepatocellular receptor A4*15: Triggering receptor expressed on myeloid cells 2 *16: Membrane glycoproteins of the Siglec family (sialic acid-binding immunoglobulin superfamily lectins).

40

Pipeline in Oncology Area
Oncology pipeline

LenvimaCombination
with®*1
KEYTRUDA

MORAb-202*4/ FZEC
Antibody-drug conjugate (ADC)

E7386

*5

CBP/β-catenin inhibitor
BB-1701*6

ADC

E7090 FGFR1,2,3 inhibitor
H3B-6545 ERα inhibitor
E7389-LF Liposomal formulation

1L Hepatocellular carcinoma(combination with TACE*2, LEAP-012)

Non-clinical

Phase I

Phase II

Phase III

Submission

Approved

Achieved LPI*3

1L Esophageal carcinoma (LEAP-014)

Achieved LPI

1L Gastric cancer (LEAP-015)
2L Head and neck cancer (LEAP-009)
Non-small cell lung cancer
Ovarian cancer, peritoneal cancer, fallopian tube cancer
Endometrial carcinoma, ovarian cancer

Phase I/II study

Solid tumors (combination with KEYTRUDA®)

Phase Ib/II study

Progress since February 2024

Solid tumors (combination with Lenvima)
Solid tumors
Breast cancer
Biliary tract cancer
Breast cancer
Breast cancer

Phase I/II study

Solid tumors

Phase Ib/II study

Solid tumors (combination with nivolumab) *7

Phase Ib/II study

E7130*8

Next-generation drug improving
tumor microenvironment

Solid tumors

E7766

STING agonist

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 *1: LEAP-004 for Melanoma 2L and LEAP-005 for Gastric cancer, colorectal cancer, glioblastoma, biliary tract cancer, and pancreatic cancer
have finished. *2: Transcatheter Arterial ChemoEmbolization *3: Last Patient In *4: Co-development with Bristol Myers Squibb. Generic name is farletuzumab ecteribulin. *5: Collaboration with PRISM BioLab *6: Entered into a
joint development agreement with Bliss Biopharmaceutical (Hangzhou) Co., Ltd with option rights for a strategic collaboration *7: Development in collaboration with Ono Pharmaceutical Co., Ltd. *8: Compound co-created with
Harvard University

41

Lenvima Revenue by Region andAchievement of Milestones with Merck & Co., Inc., Rahway, NJ, USA
Americas *1

China

EMEA*2

Japan

297.6 billion yen

296.5 billion yen

204.1

204.0

119% YoY

ALA*3

100% YoY

249.6 billion yen

161.6

Sales milestone payment
received upon achievement of
1.8 billion USD revenue FY2022:
125 million USD (16.7 billion yen)

26.9

24.0

30.9

38.2

39.5

13.7
11.1

15.5
13.0

15.0
14.0

32.2

FY2022 results

FY2023 results

FY2024 forecast

Figures are approximate.
Chart not to scale

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

Sales milestone payment
received upon achievement of
2.0 billion USD revenue FY2023:
125 million USD (18.9 billion yen)

FY2022 results
150 million USD (19.9 billion yen)

FY2023 results
125 million USD (18.9 billion yen)

1: North America *2: Europe, the Middle East, Africa, Russia, and Oceania *3: South Korea, Taiwan, India, ASEAN, Latin America, etc.

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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).
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