q2 fy2019 (fiscal year ending march 31, 2020) …demography of dementia 5 0 50 100 150 20.4 22.6...

Q2 FY2019(Fiscal Year Ending March 31, 2020)

Financial Results Presentation

Eisai Co., Ltd.October 30, 2019

Safe Harbor Statement

Materials and information provided during this presentation may contain so-called “forward-looking statements.” These statements are

based on current expectations, forecasts and assumptions that are subject to risks and uncertainties that could cause actual

outcomes and results to differ materially from these statements.

Risks and uncertainties include general industry and market conditions, and general domestic and international economic conditions

such as interest rate and currency exchange fluctuations. Risks and uncertainties particularly apply with respect to product-related

forward-looking statements. Product risks and uncertainties include, but are not limited to, technological advances and patents

attained by competitors; challenges inherent in new product development, including completion of clinical trials; claims and concerns

about product safety and efficacy; regulatory agency examination periods and obtaining regulatory approvals; domestic and foreign

healthcare reforms; trends toward managed care and healthcare cost containment; and governmental laws and regulations affecting

domestic and foreign operations.

The Company cannot guarantee the actual outcomes and results for any forward-looking statements.

Furthermore, for products that are approved, there are manufacturing and marketing risks and uncertainties, which include, but are

not limited to, inability to build production capacity to meet demand, unavailability of raw materials, and failure to gain market

acceptance.

The Company 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.

1

1H FY2019 Consolidated Statement of Income (IFRS)Achieved target revenue, operating profit

and profit for the period

April-September 2018 April-September 2019Results % Results % YoY

Revenue 310.1 100.0 299.3 100.0 96Cost of Sales 92.0 29.7 83.2 27.8 90

Gross profit 218.1 70.3 216.1 72.2 99R&D expenses 65.0 21.0 68.0 22.7 105

Partner’s share of R&D expenses 89.3 28.8 104.3 34.9 117SG&A expenses 104.8 33.8 120.5 40.3 115Other income & expenses 0.0 0.0 4.4 1.5 -

Operating profit 48.4 15.6 32.0 10.7 66Profit for the period 36.3 11.7 27.4 9.1 75Profit for the period(Attributable to owners of the parent) 32.7 10.5 27.0 9.0 83

ROE (%) 10.7 8.7End of March 2019 End of September 2019

Net DER*1 -0.32 -0.24Ratio of equity attributable to owners of the parent (%) 58.6 60.41H FY2019 average exchange rates: 1 USD: 108.62 yen (-1.5% YoY), 1 EUR: 121.41 yen (-6.5% YoY), 1 GBP: 136.73 yen (-6.9% YoY), 1 RMB: 15.68 yen (-6.3% YoY)*1: Net DER=(“Interest-bearing debt” (“Bonds and borrowings”) – “Cash and cash equivalents” – “Time deposits exceeding three months, etc.” – “Investment securities

held by the parent company”) / “Equity attributable to owners of the parent”2

(Billions of yen, %)

310.1 299.3

2,400

2,600

2,800

3,000

3,200

3,400

2018年

4-9月

売上収益

グローバル

ブランドの

拡大

日本事業中国・アジアレンビマ

肝細胞がん

承認

マイルストン

エルメッド

エーザイ

譲渡

その他増減 2019年

4-9月

売上収益

Breakdown of Revenue MigrationExpansion of Lenvima offset the difference of milestone payment

receipt, business transfer and return of marketing rights

+26.8（億円）

-10.9 B yenYoY

+4.4

*1

<Factors for decrease> Return of marketing rights for Lipacreon (Q1 FY2018) Transfer of rights for Prialt (Q1 FY2018)

-12.2

<Amount increased>Lenvima 23.5Fycompa 2.1BELVIQ 1.1Halaven 0.1

+2.3

-9.9

*2

-22.2

3

(Billions of yen)

340

320

300

280

260

240

* Figures shown in breakdown are approximate*1: Revenue from Lenvima, Halaven, Fycompa, and BELVIQ, excluding revenue from Japan business*2: Excluding the revenue from Elmed Eisai Co., Ltd. and return of marketing rights for Lipacreon in Q1 FY2018*3: Revenue from China and Asia/Latin America region, excluding revenue from global brands *4: Hepatocellular carcinoma

April-September 2018

Revenue


Revenue

Global brands*1 Japan business*2

China and Asia business*3

Transfer of shares of

Elmed Eisai Co., Ltd.

OthersMilestone payments associated with HCC*4 indication

approvals of Lenvima

48.432.0

0

200

400

600

800

2018年

4-9月

営業利益

グローバル

ブランドの

拡大

日本事業中国・アジアレンビマ

肝細胞がん

承認

マイルストン

利益折半

費用の増加

研究開発費の

増加

その他 2019年

4-9月

営業利益

+2.6 -22.2

*3

4

(Billions of yen)

-16.4B yenYoY

-14.9

65.0 68.0

24.336.3

2018年度

4-9月

2019年度

4-9月

Partners' share of R&D costsR&D expenses

(Reference) R&D expenses including partners’ share of cost

(Billions of yen)

<Factors for increase> Gain on transfer of shares of Elmed Eisai Co., Ltd. (FY2019 Q1) 4.4<Factors for decrease> Return of marketing rights for Lipacreon (Q1 FY2018) Transfer of rights for Prialt (Q1 FY2018)

89.3

104.3

+4.1

-3.0

2018年4-9月営業利益

グローバルブランドの拡大

日本事業中国・アジア

レンビマ肝細胞がん承認

マイルストン

利益折半費用の増加

研究開発費の増加

その他 2019年4-9月営業利益*1

*2*3

-6.9

Breakdown of Operating Profit MigrationAlong with the growth of Lenvima and business in China, proactively invested in R&D through partnership model

80

40

60

20


Operating Profit

April-September

2019

Global brands*1

Japan business*2

China and Asia

business*3

OthersMilestone payments associated with HCC*4

indication approvals of

Lenvima

April-September

2018


Operating Profit

Increase of shared profit

paid by Eisai*5

Increase in R&D

expenses

* Figures shown in breakdown are approximate*1: Operating profit from Lenvima, Halaven, Fycompa, and BELVIQ, excluding profit from Japan business*2: Excluding the profit from Elmed Eisai Co., Ltd. and return of marketing rights for Lipacreon in Q1 FY2018*3: Operating profit from business in China and Asia/Latin America region, excluding profit from global brands*4: Hepatocellular carcinoma *5: Shared profit associated with strategic partnership with Merck & Co., Inc., Kenilworth, N.J., U.S.A.

*1: World Alzheimer Report 2018 *2: High income countries are defined as those with a GNI (Gross National Income) per capita of $12,736 or more, Middle income countries are defined as those with a GNI per capita of more than $1,046 but less than $12,736 and Low income countries are defined as those with a GNI per capita of $1,045 or less(World Alzheimer Report 2015) *3: World Alzheimer Report 2015 *4: 2017 Aging society white paper (Cabinet Office) *5: New Orange Plan (January 2015) estimated by Ministry of Health, Labour and Welfare

Estimated number of people with dementiain each region*3

Africa Europe AsiaAmericas2018 2030 2050

82million

152million

High incomecountries*2

(32%)

Middle incomecountries*2

(65%)

Low incomecountries*2

(3%)

Future estimation of number of people with dementia in Japan*4

2012 2015 2020 2025 2030 2040 2050

Number of people with dementia 4.62 million 5.25 million 6.31 million 7.30 million 8.30 million 9.53 million 10.16 million

The numbers of people with dementia in the world were estimated at 50 million in 2018*1 and 152 million in 2050.Higher proportion of dementia in middle income countries are reported and it is growing rapidly, mainly in Asia.

The total number of people with dementia is estimated at approximately over 10 million in Japan:6.31 million*4 with dementia and 4 million*5 with mild cognitive impairment (MCI).

Transition of number of people with dementia worldwide*1(million)

50million

Demography of Dementia

5

0

50

100

150

20.4

22.6

19.0

10.4

19.4

43.1

69.2

58.0

37.9

0% 50% 100%

604.0(Approx. 66 trillion yen)

817.9(Approx. 90 trillion yen)

0

500

2010 2015

High income countries

Low income countries

Medicalcost

Social care cost

Family care cost

• Huge burden on care cost, including social cost for care and family burden for care, compared to medical cost

• Cost for dementia is estimated at approximately 90 trillion yen in 2015, and will increase up to approximately 220 trillion yen in 2030

*1: High income countries are defined as those with a GNI (Gross National Income) per capita of $12,736 or more, Middle income countries are defined as those with a GNI per capita of more than $1,046 but less than $12,736 and Low income countries are defined as those with a GNI per capita of $1,045 or less. Source: World Alzheimer Report 2015 *2: Alzheimer’s Association (2015). Changing the Trajectory of Alzheimer’s Disease: How a treatment by 2025 saves lives and dollars *3: Tama University, Center for Rule-making Strategies, July 2018

Cost estimation of dementia worldwide*1

(Billion USD)

Middle income countries

Estimated reduction in medical and care cost through five years

delay of dementia onset(1) US*2

(2) Japan*3

It is estimated that if a treatment method would be introduced that delays the onset of dementia by five years in 2025, it would reduce by $367 billion (approximately 40 trillion yen) the total costs of care, including Medicare, Medicaid, co-pay and others) per year in 2050

Similarly, if a treatment method would be introduced that delays the onset of dementia by five years, it is estimated that medical and nursing cost would be reduced by approximately 1.9 trillion yen (1 trillion yen in medical cost and 900 billion yen in care cost) in fiscal 2025

Cost Estimation of Dementia

6

Aducanumab*

Despite studies were announced as discontinued following a futility analysis, new analysis of larger dataset of aducanumab

(EMERGE/ENGAGE) represents the first time a Phase III program has demonstrated that clearance of aggregated amyloid beta can reduce

the clinical decline of Alzheimer’s disease.

The new analysis of larger dataset showed EMERGE to be statistically significant on the pre-specified primary endpoint and Biogen believes

data from a subset of ENGAGE support findings from EMERGE.

Safety and tolerability profile was consistent with prior studies of aducanumab.

Based on discussions with the FDA, Biogen plans to file a Biologics License Application (BLA) in early 2020 and will continue dialogue

with regulatory authorities in international markets including Europe and Japan.

7EMERGE and ENGAGE were Phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of aducanumab. * Investigational. Co-development with Biogen.

8

New analysis of larger dataset showed that aducanumab reduced clinical decline in patients with early Alzheimer’s disease as measured by the pre-specified primary and

secondary endpoints in EMERGE

Aducanumab*1

EMERGE

Cognitive function and activities of daily living (Pre-specified ITT*2 analysis)

Reduction of brain amyloid

% Reduction vs. Placebo*3

p-valueLow dose(N*4=543)

High dose(N*4=547)

CDR-SB -14%0.117

- 23%0.010

MMSE 3%0.690

-15%0.062

ADAS-Cog13 -14%0.167

- 27%0.010

ADCS-ADL-MCI

-16%0.156

- 40%0.001

EMERGE and ENGAGE were Phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of aducanumab. *1: Investigational. Co-development with Biogen. *2: Intent to treat, a method of analysis, which includes all patients for the analysis, such as patients who discontinued or dropped *3: Difference in change from baseline vs. placebo at Week 78. Negative percentage means less decline in the treated arm. *4: Numbers of all randomized and dosed subjects that were included in the analysis. Placebo = 548 (ITT) and 313 (OTC)

Aducanumab*1

ENGAGE

9

ENGAGE consistent with EMERGE in subset of patients with sufficient exposure to 10mg/kg aducanumab

EMERGE and ENGAGE were Phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of aducanumab *1: Investigational. Co-development with Biogen

≥ 10 uninterrupted 10 mg/kg dosing intervals at steady-statePlacebo

Amyloid PET CDR-SBEMERGE EMERGEENGAGE ENGAGE

10

Phosphorylation of tau in CSF

EMERGE ENGAGE

Placebon=22

Lowdosen=28

Highdosen=15

Placebon=17

Lowdosen=21

Highdosen=18

EMERGE ENGAGE

CSF total Tau

Adju

sted

mea

n ch

ange

from

bas

elin

e (S

E)U

nit:

pg/m

l

Adju

sted

mea

n ch

ange

from

bas

elin

e (S

E)U

nit:

pg/m

l

Placebon=23

Lowdosen=29

Highdosen=14

Placebon=17

Lowdosen=21

Highdosen=16

P=0.0001P=0.0106 P=0.0075P=0.0016n.s. n.s. n.s. n.s.5

0

-5

-10

-15

-20

-25

0-20-40-60-80

-100-120-140-160-180-200-220

Aducanumab*1 (EMERGE/ENGAGE)Results of cerebrospinal fluid (CSF) biomarkers of tau

pathology and neurodegeneration in AD supported clinical outcomes

EMERGE and ENGAGE were Phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of aducanumab * 1: Investigational. Co-development with Biogen.

CSF biomarkers of tau pathology and neurodegeneration in AD are reduced in aducanumab-treated subjects

Aducanumab*1

Timeline, events and outline of available datasets

Protocol amendments to enable more patients to reach high dose aducanumab (10mg/kg)

August 2015ENGAGE initiated

August 2015ENGAGE initiated

September 2015EMERGEinitiated

September 2015EMERGEinitiated

Protocol amendment in July 2016: Patients dose suspended due to ARIA*2

to resume aducanumab treatment at the originally assigned dose

Protocol amendment in March 2017:ApoE4 carriers to titrate to 10 mg/kg

Period for patient enrollment for futility analysis ~ June 2017

Period for patient enrollment for the new analysis ~ July 2018 December 2018:

Futility analysisdata cutoff date

March 2019:Larger Dataset

analysis data cutoff date

1,748

3,285

Dataset Subject Population EMERGEn(%)

ENGAGEn(%)

Futility Opportunity to Complete (OTC)*3 803 (49%) 945 (57%)

Larger DatasetOpportunity to Complete (OTC)*4 982 (60%) 1,084 (66%)

Intent to Treat (ITT) *5, 6 1,638 (100%) 1,647 (100%)

Larger dataset

11

EMERGE and ENGAGE were Phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of aducanumab. *1: Investigational. Co-development with Biogen. *2: ARIA = amyloid-related imaging abnormality *3: Subjects who have had the opportunity to complete week 78 visit by December 26, 2018 *4: Subjects who have had the opportunity to complete week 78 visit by March 20, 2019 *5: All subjects’ data (data after March 20, 2019, are censored for efficacy analyses) *6: Intent to treat: a method of analysis, which includes all patients for the analysis, such as patients who discontinued or dropped

Number of subject for new analysis

Futility(Subjects who have

had the opportunity to complete week 78 visit

by December 26, 2018.)

Larger DatasetAll subjects’ data (data after March 20, 2019,

are censored for efficacy analyses)

AducanumabEffect of protocol amendments

In the new analysis of larger dataset, data from 3,285 subjects were used, with more patients having greater exposure to high dose aducanumab

Differences in exposure to high dose aducanumab largely explain the different results between the futility analysis and the new analysis of this larger dataset, as well as the different results between the two studies

As a result, the proportion of high dose exposure in ENGAGE was less compared to EMERGE where high dose opportunity were increased by the protocol amendment

EMERGE and ENGAGE were Phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of aducanumab. * 1: Investigational. Co-development with Biogen *2: Intent to treat, a method of analysis, which includes all patients for the analysis, such as patients who discontinued or dropped 12

13

BAN2401*1

Study 201

*1: Investigational. Co-development with Biogen. Licensed in from BioArctic. *2: Estimation based on baseline value as 1.10 threshold of composite SUVR for negative conversion *3: Alzheimer’s Disease Composite Score *4: Aβ-Tau-Neurodegeneration *5: First time as a large scale late-stage clinical study

0 12 18

*

*

Months

Amyloid PET

10 mg/kg biweekly*P<0.0001

Adju

sted

Mea

n C

hang

e Fr

om B

asel

ine

(±SE

)

*

*

(p<0.034)

ADCOMS*3

(p<0.027)

(p<0.033)

0 6 12 18

p-tau Neurogranin

NfLAd

just

edM

ean

Cha

nge

From

Bas

elin

e (±

SE)

10 mg/kg biweekly

Months

A-be

ta re

duct

ion

0

-2

-4

-6

-8

-10

-12

-14Placebo10 mg/kg monthly

Cog

nitiv

e de

clin

e

Placebo10 mg/kg monthly

+0.01

-12Combined 10mg/kg

Placebo

Med

ian

chan

ge fr

om b

asel

ine

(pg/

ml)

10mg/kg bi-weekly and 10mg/kg monthly groups were combined to increase the sample size in CSF sub group

Placebo Combined 10mg/kg

Med

ian

chan

ge fr

om b

asel

ine

(pg/

ml)

+13.5

-58

Placebo Combined 10mg/kg

+156

+75

48% median observed difference vs placebo

0.05

0.00

-0.05

-0.10

-0.15

-0.20

-0.25

-0.30

-0.35

0.00

0.05

0.10

0.15

0.20

Med

ian

chan

ge fr

om b

asel

ine

(pg/

ml)

Med

ian

chan

ge fr

om b

asel

ine

(pg/

ml)

10

0

-10

-20

-30

-40

-50

-60

16014012010080604020

0

30% slowing in cognitive decline compared with

placebo arm

Disease modifying effect was observed by both clinical functionand multiple ATN*4 biomarkers in the brain for the first time*5

Removed brain amyloid to amyloid negative level*2

BAN2401*1

Progress of Clarity AD and preparation for Phase III studies for preclinical AD

Final readout of Primary endpoint targeted in Q1 FY2022

Phase III study (Clarity AD) is ongoingPopulation: 1,566 patients with early ADThe study is ongoing in Japan, US, EU and AsiaSubmitted Clinical Trial Application (CTA) in 1H FY2019. Review is

underway and Quality Site*2 selection is ongoing to initiate the study in FY2019 in China

*1: Investigational antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic. Co-development with Biogen*2: The sites which have expertise in AD field, accumulated experience for clinical studies for AD, and capability to enroll right patients. *3: The ACTC, funded by the National Institute on Aging at the US National Institutes of Health (NIH), provides the infrastructure for academic clinical trials in Alzheimer’s Disease and related dementias. The ACTC was established in December 2017 and includes 35 primary clinical sites across the United States *4: Target of the study is clinically normal individuals (no cognitive impairment) with intermediate levels of brain amyloid, and are at increased risk for further amyloid accumulation *5: Target of the study is clinically normal individuals (no cognitive impairment) who have elevated levels of brain amyloid and are at increased risk of cognitive decline due to AD14

AD prevention study planned in partnership with Alzheimer’s Clinical Trials Consortium (ACTC)*3

Pursuing optimal study design in consultation with ACTCInitiated consultation with regulatory authorities.

Plan to initiate Phase III studies (A3*4, A45*5) in 2020.

Establishment of Dementia FranchiseOrigin of two compounds

Aducanumab*1 is a human monoclonal antibody derived from a de-identified library of B cells collected from healthy elderly subjects with no signs of cognitive impairment or cognitively impaired elderly subjects with unusually slow cognitive decline

BAN2401*1,2 is a humanized monoclonal antibody comprised of Aβ protofibrils as an antigen, with Arctic mutation based on the research of cases on Swedish familial AD with Arctic mutation, which concluded that abnormal accumulation of Aβ protofibrils may be a cause of AD onset

15EMERGE and ENGAGE were Phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of aducanumab. *1: Investigational. Co-development with Biogen. *2: Antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic.

16(Mean±SD)

Elenbecestat(N=1054)

Placebo(N=1076)

Mean Age 71.9 72.0CDR-SB 2.63±1.263 2.62±1.197ADAS-cog11 12.599±5.2691 12.433±4.9088

MMSE 25.761±2.5491 25.764±2.5980ADCOMS 0.343±0.1494 0.340±0.1403

Demographic and Baseline Characteristics

Safety related Eg. adverse events, details of severe adverse event cases, ARIA*3

Clinical endpoints related CDR-SB, ADAS-Cog, MMSE, ADCOMS

DSMB*2 reviewed safety data including clinical endpoints

2,130 subjects (data up to 24 months including approx. 1,700 subjects who were treated for 6 months and approx. 900 subjects were treated for 12 months) were reviewed by DSMB.Patient background between placebo arm and elenbecestat arm were equal and in-depth analysis is being conducted based on these data

*1: Investigational. Co-development with Biogen *2: Data Safety Monitoring Board *3: Amyloid-related imaging abnormalities

Elenbecestat*1

Discontinuation of Phase III program (MISSION AD)

Even though the increase in adverse events, such as weight loss, mental symptoms, and skin symptoms was observed, frequency was low. These adverse events are consistent with the results of clinical trials for BACE inhibitor in the past.

Impact on cognitive function were analyzed with clinical endpoints. When 80% of lower confidence limit exceeded the mean value of placebo in CDR-SB index, it was evaluated as decline.

All case analysis suggested decline in CDR-SB index at 24 months, but did not show decline as defined by any clinical evaluation index at any other time, and the average was the placebo endpoints. In addition, the mean values were distributed near mean value of placebo.

Comprehensive review was conducted, including the success rate based on conditional power*2. As a result, DSMB recommended discontinuation of the study due to an unfavorable risk-benefit ratio.

Administration was immediately stopped, and a follow up of the enrolled subjects is underway. Data at the point of discontinuation and after certain period of time are gathered and final analysis will be conducted. Analyzed data will be presented at clinical conference in the future.

*1: Co-development with Biogen *2: The rate whether pre-specified hypothesis (Suppress disease progression) would be proven or not in planned final analysis17

Elenbecestat*1

Discontinuation of Phase III program (MISSION AD)

Aβ Theory, Our Update

Dimer Oligomer Protofibrils Amyloid plaqueFibrilMonomer

Aβ aggregation

AβAPP

BACE

γ-secretase

AβExtracellular

Intracellular

Neurofilament LNeurogranin P-tauTotal tau

4. It is important to examine biomarkers associated with downstream of Aβ-Tau-neurodegeneration (ATN)

aggregateaggregate

dissociatedissociate

1. Less decline of cognitive function and benefits on activities of daily living by reducing Aβ aggregates were demonstrated in large scale studies (Phase II study of BAN2401*1,2 and Phase III studies (EMERGE/ENGAGE) of aducanumab*2)

2. BACE inhibitor may be associated with several substrates other than amyloid precursor protein (APP) as well as bring various effects. Therefore, high-selectivity to APP is required. Potential indication is prevention to accumulation of Aβ aggregates, or maintenance therapy after Aβ aggregates are removed by antibodies.

18

5. Of Aβ aggregates, the toxicity of protofibrils may be the most important. Therefore, BAN2401, which has high-selectivity to protofibrils, has high expectations.

Tau

Microtubule

EMERGE and ENGAGE were Phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of aducanumab. *1: Investigational antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic. *2: Co-development with Biogen

Phosphorylationof tau

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

4Rs for Potential Successful Drug Development

Right Hypothesis

Right Population

Right Dosage

Right Endpoint

19

NeurologyObtained 2 approvals; 2 projects are under review;

1 project is under preparation for submission; and 1 project is ongoing for Phase III

Fycompa (AMPA receptor antagonist)Partial onset seizures*1

Approved in Chinabased on Priority Review

Equfina*2(MAO-B inhibitor)

Parkinson’s disease approved in JapanApproved indication: improvement of wearing-off phenomenon*3 in patients with Parkinson’s disease under treatment with a drug containing levodopa

Plan to launch in November 2019

Immunodementia Project*9 AD

EphA4 Project*8 (Synapse modulator) ADE2511 (Synapse regenerant) AD

E2814*7 (Anti-tau antibody) AD

BAN2401*4,5 (Anti-Aβ protofibrils antibody)Early AD Clarity AD ongoing Under preparation for preclinical AD

E2027 (PDE9 inhibitor)Dementia with Lewy bodies Phase II/III ongoing

All projects are investigational except for Fycompa in China and Equfina in Japan *1: Approved for the treatment of partial onset seizures in epilepsy patients 12 years of age and older *2: Meiji Seika Pharma Co., Ltd. holds the manufacturing and marketing approval for Equfina, and Eisai exclusively sells it in Japan. *3: As the disease progresses, levodopa’s duration of effect decreases, and there are cases where patients may experience wearing-off phenomena, a return of Parkinson’s disease symptoms before the next dose. *4: Co-development with Biogen *5: Antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic. *6: Irregular Sleep-Wake Rhythm Disorder *7: First clinical candidate from drug discovery collaboration between Eisai and University College London (UCL), UK *8: Research at KAN Research Institute *9: Research at G2D2 (Eisai Center for Genetics Guided Dementia Discovery)

Lemborexant(Dual orexin receptor antagonist)

Lemborexant (Dual orexin receptor antagonist)ISWRD*6 associated with AD/dementia

20

Fycompa (AMPA receptor antagonist)

Aducanumab*4(Anti-Aβ antibody) Plan to submit in early 2020AD Under preparation for submission in the U.S.

Insomnia Under review in the U.S. and Japan

Monotherapy for partial onset seizuresUnder review in Japan

Plan to launch in FY2019

Approved

Under review

Phase III(Including projects under preparation)

Phase II

Phase IUnder preparation

Preclinical

Approved in Sep. 2019

Under preparation

for submission

Approved in Sep. 2019

2.0 2.33.7 5.84.3

6.9

7.114.4

28.4

2018年度4-9月 2019年度4-9月

Americas

China

Japan

EMEA

Asia/Latin America

• Over 80% of patients with uHCC were treated with Lenvima as a first-choice treatment*4

LenvimaPursuing Over 1 Billion USD Revenue in FY2019

to Reach Blockbuster StatusUpward revision of revenue forecast to 119.0B yen*1

• Lenvima expanded contribution to patients with uHCC in China, where the largest number of patients with uHCC are reported

• Treatment provided to approximately 10,000 patients since launch in November 2018*3

• Discussions on-going with the authorities to potentially add Lenvima to China’s National Reimbursement Drug List in 2019 that would expand patient access for Lenvima in uHCC

China 7.1B yen

Japan 6.9B yen (159% YoY)

• Unresectable hepatocellular carcinoma (uHCC) indication drove rapid growth in the U.S.

• Aim to expand contribution to patients by additional indication of endometrial carcinoma in combination with KEYTRUDA®*2, approved on September 17, 2019

Americas 28.4B yen (197% YoY)Revenue of Lenvima (Billions of yen)

50.5B yen207% YoY

*1: Previously disclosed forecast of Lenvima in FY2019 was 116.0B yen *2: KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck &Co., Inc., Kenilworth, N.J., U.S.A. Projects for Lenvima are under joint development with Merck & Co., Inc., Kenilworth, N.J., U.S.A. Approved for patients with advanced

endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation in the U.S. *3: Internal estimates *4: Source: Internal estimates based on MDV analyzer of Medical Data Vision Co., Ltd.

24.5B yen

21

• Contribution to patients steadily expanded in Russia, Australia, and Germany after being listed as eligible for reimbursement

EMEA 5.8B yen (156% YoY)

April-September2018

April-September2019

22

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A. Projects for Lenvima are under joint development with Merck & Co., Inc., Kenilworth, N.J., U.S.A. *1: Combination therapy of Lenvima and KEYTRUDA®. Approved for patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation in the U.S. *2: Makker V. et al. Gynecol Oncol Res Pract. 2017 19 *3: Source: American Cancer Society. These estimates include both endometrial cancers and uterine sarcomas. Up to 10% of uterine body cancers are sarcomas, so the actual numbers for endometrial cancer cases and deaths are slightly lower than these estimates. *4: Decision resources *5: Nagle C.M. et al. J Gynecol Oncol 2018 e39 *6: Microsatellite instability high/deficient mismatch repair pathway *7: This program aims to improve the efficiency of the review process for applications to ensure that treatments are available to patients as early as possible. *8: This is an accelerated approval reviewed under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to improve the efficiency of the review process for applications to ensure that treatments are available to patients as early as possible

Endometrial carcinoma: Unmet medical need remains Approximately 60,000 new cases are diagnosed and approx. 12,000 deaths occur*3

in the U.S. Number of patients with endometrial carcinoma 2nd line is estimated to be 14,000*4

Patients (2nd line advanced endometrial carcinoma patients whosetumor is not MSI-H or dMMR+*6) eligible for approved indication

is estimated to be approx. 10,000 annually in the U.S.

Current standard first line treatment:Combination therapy with two chemotherapy agents, includingplatinum agent

Combination with KEYTRUDA®

Endometrial Carcinoma*1

First new treatment option in approximately 50 years since FDA approved megestrol acetate in 1971*2

75%NoMSI-H/dMMR

MSI-H/dMMR ratiofor endometrial cancer*5

Aim to provide new treatment option for patients with refractory endometrial cancer

Approved under new FDA-Initiated Program “Orbis”*7, this was the first to receive simultaneous review decisions in the U.S., Australia and Canada, 3 months after being submitted on June 17, 2019*8

25%MSI-H/dMMR

23

Complete responseobserved in 8 cases

++++++ + +

+

+ + + + + + ++++ ++++ + + + + + + ++++ ++++ + + ++○ ○ ○○ ○○


Advanced Endometrial Carcinoma*1

Final results on the data that led to the accelerated approval were presented at ESMO*2

Histopathological type■Endometrioid adenocarcinoma ■Clear cell adenocarcinoma■Serous adenocarcinoma ■Others

PD-L1 status +: positive, ○: unknown

Confirmed complete responses in patients with refractory serous adenocarcinoma and clear cell adenocarcinoma.Deep and durable tumor shrinkage was observed

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A. Projects for LENVIMA are under joint development with Merck & Co., Inc., Kenilworth, N.J., U.S.A. *1: Approved for patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation in the U.S *2: European Society for Medical Oncology *3: ESMO Congress 2019. Abstract No. 994O. The most common treatment-related TEAEs (any grade) were hypertension, diarrhea, decreased appetite, fatigue, hypothyroidism. *4: Response Evaluation Criteria In Solid Tumors *5: Microsatellite instability high/deficient mismatch repair pathway*5: Objective Response Rate *7: January 10, 2019 *8: Complete Response *9: Duration Of Response *10: Progression-Free Survival *11: Overall Survival*12: Not Evaluable

RECIST v1.1*4 Independent imaging review ORR*6 DOR*9

(median)PFS*10

(median)OS*11

(median)Time of data cutoff*7 CR*8

94 patients who are not MSI-H/dMMR*5 38.3% 10.6% NE*12 5.4 months 16.4 months

Maximum tumor shrinkage

>0% 72/84 (85.7%)

>50% 26/84 (31.0%)

>75% 13/84 (15.5%)

Interim analysis of Study 111 in 108 patients with metastatic endometrial carcinoma who had progressed following prior systemic therapy*3

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rate

(%)

*1: Approved for monotherapy for the treatment of unresectable hepatocellular carcinoma *2: Barcelona Clinic Liver Cancer stage B. Intermediate stage of HCC*3: Objective Response Rate *4: Kudo M. et al. Lancet 2018: 1163-1173 *5: Real World Data *6: Kudo M. et al. Cancers 2019 11 1084 *7: Transcatheter Arterial ChemoEmbolization *8: The International Liver Congress 2019 “Assessing Response in Advanced Liver Cancer – Does Response Matter?” *9: Albumin - bilirubin grade *10: Radiofrequency ablation *11: Sato N. et al. Anticancer Res. 2019 5695-5701 *12: 10 clinical questions and consensus statement were defined among experts from Japan, China, South Korea, Taiwan, Hong Kong and Singapore, aiming at suggesting science-based optimal treatment option for patients with intermediate stage HCC at the 10th Asia-Pacific Primary Liver Cancer Expert Meeting (APPLE) held in August 2019 in Hokkaido, Japan24

Lenvima monotherapy for Hepatocellular Carcinoma*1

Contribution to patients with BCLC-B*2 uHCC with conversion

Unresectable/ TACE refractory and HCC

Potential tumor shrinkage

with Lenvima

Selective TACE, resection, RFA*10 liver transplant

TumorPotential conversion to curative treatment

Pursuing paradigm shift in treatment aiming for radical treatment of uHCC by offering a potentially clinically meaningful treatment worldwide

Patient contribution has been expanded with Lenvima’s potential in conversion based on the evidence*11 that

showed prolonged survival time with Lenvima administration for patients with uHCC in BCLC-B

Experts in Asia, including Japan, presented APPLE expert consensus*12, which recommended that Lenvima should be the first treatment option for patients with

HCC in BCLC-B and TACErefractory

ORR*3: 40.6%REFLECT trial*4

ORR: 38-60%RWD*5 in Japan

ORR: 73.3%*6

BCLC-B, TACE*7-Naive

ORR: 80.9%*8

BCLC-B, ALBI grade 1*9, TACE-Naive

FY2017

FY2018

FY2019

FY2019


Unresectable Hepatocellular CarcinomaTumor response was observed including complete responses

25

Lenvima + KEYTRUDA®

combination therapyORR

(including unconfirmed responses)

ORR PFS(median)

OS(median) DCR*11

mRECIST*9 by Independent imaging review 52% 46% 9.7 months 20.4 months 85%RECIST v1.1*10 by Independent imaging review 40% 33% 9.5 months 20.4 months 85%

(Ref.) Tecentriq + Avastin combination therapy*12

RECIST v1.1 by Independent imaging reviewORR

(including unconfirmed responses)

ORR PFS(median)

OS(median) DCR

Phase I Arm A (104 subjects) ー 36% 7.3 months 17.1 months 71%

Phase I Arm F (60 subjects) ー 20% 5.6 months Unsettled 67%

Complete responseobserved in 5 cases

HBV 14HCV 20Alcohol 13

■ Part 1 dose-limiting toxicities (n=6)■ Part 2 dose-escalating (n=54)

High efficacy was demonstrated in combination therapy of Lenvima and KEYTRUDA®:OS*2: 20.4 months, PFS*3: 9.7 monthsORR*4,5: 52%*6 and 40%*7

Tumor response was observed in patient population of which 70% were BCLC*8-C

Interim analysis of Phase Ib study (Study 116) in 67 patients with unresectable hepatocellular carcinoma*1

Breakthrough Therapy designation granted by the U.S. FDA in July 2019KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A. Projects for Lenvima are under joint development with Merck & Co., Inc., Kenilworth, N.J., U.S.A. All projects are investigational. *1: European Society for Medical Oncology (ESMO) 2019 Congress. Abstract No.747P. The most common AEs (any grade) were diarrhea, decreased appetite, hypertension, fatigue and aspartate aminotransferase increased. *2: Overall survival *3: Progression-free survival *4: Objective response rate *5: Including unconfirmed responses *6: Based on mRECIST *7: Based on RECIST v1.1. *8: Barcelona Clinic Liver Cancer *9: modified Response Evaluation Criteria In Solid Tumors *10: Response Evaluation Criteria In Solid Tumors *11: Disease control rate *12: ESMO Congress 2019 Abstract No. LBA39. Roche announced on October 21, 2019 that Phase III IMbrave150 study evaluating Tecentriq in combination with Avastin met both of its co-primary endpoints demonstrating statistically significant and clinically meaningful improvements in OS and PFS compared with standard-of-care sorafenib.

Tum

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rate

(%)

PD-L1 status + : positive,○: unknown

++++++○○○○○○++○+○○+○○

26

irRECIST*3

Investigator review

ORR*4 DOR*5 PFS*6

(median)DCR*7

33 patients with RCC 64% 9.1

months11.3

months 100%

(Reference) RECIST v1.1*8

by Independent imaging review ORR PFS(median)

1st Line nivolumab/Ipilimumab*9 42.0% 11.6months

1st Line KEYTRUDA®/axitinib*10 59.3% 15.1months

1st Line avelumab/axitinib*11 51.4% 13.8monthsDisease control and favorable clinical

endpoints were observed in all patients

Breakthrough Therapy designation granted by the U.S. FDA in December 2017

Tum

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rate

(%)

PD-L1 (+): 36%PD-L1 (-): 30%Unconfirmed: 33%

Interim analysis for Phase Ib/II (Study 111) in 33 patients with RCC who had demonstrated disease progression after prior anti-PD-1/PD-L1 antibody treatment*2


Renal Cell Carcinoma (RCC)*1

Antitumor activity demonstrated in patients who had prior immune checkpoint inhibitor treatment

All projects are investigational. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A. Projects for Lenvima are under joint development with Merck & Co., Inc., Kenilworth, N.J., U.S.A. *1: Metastatic Clear Cell (mcc) Renal Cell Carcinoma (RCC). *2: European Society for Medical Oncology (ESMO) 2019 Congress. Abstract No. 1187PD. The most common AEs (any grade) were fatigue, diarrhea, dysphonia, stomatitis and nausea. *3:immune-related Response Evaluation Criteria In Solid Tumors *4: Objective Response Rate *5: Duration Of Response *6: Progression-Free Survival *7: Disease Control Rate *8: Response Evaluation Criteria In Solid Tumors *9: Motzer R.J. et al. N Engl. J. Med. 2018: 1277-1290 *10: Rini B.I. et al. N Engl. J. Med. 2019 : 1116-1127 *11: Motzer R.J. et al. N Engl. J. Med. 2019: 1103-1115

Combination of Lenvima and KEYTRUDA®

• Endometrial carcinoma 2L• Endometrial carcinoma 1L (LEAP-001)• Hepatocellular carcinoma 1L (LEAP-002)• NSCLC 1L*1 (LEAP-006)• NSCLC 1L*2 (LEAP-007)• NSCLC 2L (LEAP-008)• Urothelial carcinoma 1L (LEAP-011)• Melanoma 1L (LEAP-003)

• Endometrial carcinoma, renal cell carcinoma, melanoma, head and neck cancer, urothelial cancer, non-small cell lung cancer (Phase I/II, Study 111)

• Melanoma 2L (LEAP-004)• Basket trial*3 (LEAP-005)• Hepatocellular carcinoma (Study 116)

OncologyObtained 3 Breakthrough Therapy designations; 1 SAKIGAKE designation

and eribulin derived compounds are under development

27

Breakthrough therapy designation from U.S. FDA

LenvimaMonotherapy

Thyroid cancer in China(Study 308)

Approved

Phase I(including under

preparation)

PhaseII

Phase III

H3B-6545ERα inhibitor

Breast cancer (Phase I/II)

E7389-LF*4Liposomal formulation

Combination with nivolumabSolid tumors (Phase Ib/II)

H3B-6527FGFR4 inhibitor

Hepatocellular carcinoma

E7090FGFR1,2,3 inhibitorBiliary tract cancer and

others

E7386*5

CBP/β-catenin inhibitorSolid tumors

E7766*8

STING agonistSolid tumors

H3B-8800SF3B1 modulator

Hematological malignancies

LenvimaCombination with nivolumabHepatocellular carcinoma

(Study 117)

MORAb-202ADC*7

Folate receptor α (FRA)positive solid tumors

SAKIGAKE designation from Japan’s Ministry of Health, Labour and Welfare All projects are investigational except for combination therapy of Lenvima and KEYTRUDA® for the treatment of 2nd line endometrial carcinoma. KEYTRUDA® is a registeredtrademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A. Projects for Lenvima are under joint development with Merck & Co., Inc., Kenilworth, N.J., U.S.A. The LEAP studies are led and were submitted by Merck & Co., Inc., Kenilworth, N.J., U.S.A. 1L: First line, 2L: Second line *1: Non-squamous cell carcinoma, combination with chemotherapy *2: PD-L1 positive *3: Triple-negative breast cancer, gastric cancer, ovarian cancer, colorectal cancer, glioblastoma, biliary tract cancer *4: Under development in collaboration with Ono Pharmaceutical Co., Ltd. *5: Under development in collaboration with PRISM BioLab *6: Compound co-created with Harvard University *7: Antibody-drug conjugate *8: Under preparation for Phase I study

LenvimaCombination with KEYTRUDA®

or everolimusRenal cell carcinoma 1L

(Study 307)

E7130*6Next-generation drug improving

tumor microenvironmentSolid tumors

Upward Revision of FY2019 Consolidated Earnings Forecast (IFRS)Achieving FY2020’s profit*1 target a year ahead

by rapid expansion of Lenvima

FY2018 FY2019Results % Forecast % YoY

Revenue 642.8 100.0 680.0 100.0 106(Ref.) Other Business Revenue 79.1 12.3 103.0 15.1 130

Cost of Sales 184.5 28.7 170.0 25.0 92R&D expenses 458.3 71.3 510.0 75.0 111Partner’s share of R&D expenses 144.8 22.5 148.0 21.8 102

SG&A expenses 228.2 35.5 256.0 37.6 112Other income & expenses 0.9 0.1 4.0 0.6 462

Operating profit 86.2 13.4 110.0 16.2 128Profit for the period 66.5 10.3 82.0 12.1 123Profit for the period(Attributable to owners of the parent) 63.4 9.9 81.6 12.0 129

EPS (yen) 221.3 284.8ROE (%) 10.4 13.2DOE (%) 7.0 7.4Dividend (yen) 150 160

28

Previous disclosure

680.0103.0180.0500.0

154.5

245.02.5

103.072.5

72.0

251.311.27.1

160


FY2018 average exchange rates: 1 USD: 110.90 yen, 1 EUR: 128.40 yen, 1 GBP: 145.67 yen, 1 RMB: 16.53 yen1H FY2019 average exchange rates: 1 USD: 108.62 yen, 1 EUR: 121.41 yen, 1 GBP: 136.73 yen, 1 RMB: 15.68 yen2H FY2019 expected average exchange rates: 1 USD: 105 yen, 1 EUR: 117 yen, 1 GBP: 130 yen, 1 RMB: 14.6 yen*1: FY2020 targets, which are interim targets of mid-term business plan “EWAY 2025”:102.0B yen level operating profit, 74.0B yen level profit and over 10% ROE

29

Reference Data

April-September 2018 April-September 2019

Results % Results % YoY

Japan*1 145.4 46.9 125.8 42.0 87

Americas*2 42.8 13.8 57.9 19.3 135

China 31.8 10.3 44.7 14.9 140

EMEA*3 25.4 8.2 26.1 8.7 103

Asia and Latin America*4 24.7 8.0 24.0 8.0 98

OTC and others (Japan) 12.3 4.0 13.1 4.4 107Pharmaceutical business

total 282.4 91.1 291.6 97.5 103

Other business*5 27.7 8.9 7.6 2.5 27

Consolidated revenue 310.1 100.0 299.3 100.0 96

Revenue by Reporting Segment


30

Effective from this fiscal year, aiming for more flexible strategy execution, the Group separated OTC and others from Japan pharmaceutical business, to newly establish the OTC and others business. The financial results in the corresponding period of the previous fiscal year disclosed in the following reporting segments reflect this change of the reporting segments.*1: Revenue from generics were included in 1H FY2018 *2: North America *3: Europe, Middle East, Africa, Russia and Oceania *4: Primarily South Korea, Taiwan, Hong Kong, India, ASEAN, Central and South America *5: Income mainly from license and the pharmaceutical ingredient business of the parent company, including recognition of payments from Merck & Co., Inc., Kenilworth, N.J., U.S.A. under the strategic collaboration for anticancer agent Lenvima, which were 22.2B yen in 1H FY2018, none in 1H FY2019.

Profit by Reporting Segment


Results % YoY Results % % of revenue YoY

Japan*1 57.3 43.5 39.4 50.3 38.9 40.0 88Americas*2 16.9 12.9 39.5 30.6 23.7 52.9 181

China 11.5 8.8 36.2 21.5 16.7 48.2 187EMEA*3 11.2 8.5 44.0 11.7 9.1 45.0 105

Asia and Latin America*4 8.5 6.5 34.4 9.0 7.0 37.4 106OTC and others (Japan) 2.7 2.1 22.3 3.4 2.7 26.1 125

Pharmaceutical business total 108.1 82.2 38.3 126.6 98.0 43.4 117Other business*5 23.4 17.8 84.5 2.6 2.0 33.7 11

Reporting segment total 131.5 100.0 42.4 129.2 100.0 43.2 98R&D expenses and group

headquarters’ management costs and other expenses*6

-83.2 -97.2

Consolidated operating profit 48.4 15.6 32.0 10.7 66

31


Effective from this fiscal year, aiming for more flexible strategy execution, the Group separated OTC and others from Japan pharmaceutical business, to newly establish the OTC and others business. The financial results in the corresponding period of the previous fiscal year disclosed in the following reporting segments reflect this change of the reporting segments.*1: Profit from generics were included in 1H FY2018 *2: North America *3: Europe, Middle East, Africa, Russia and Oceania *4: Primarily South Korea, Taiwan, Hong Kong, India, ASEAN, Central and South America *5: Income mainly from license and the pharmaceutical ingredient business of the parent company, including recognition of payments from Merck & Co., Inc., Kenilworth, N.J., U.S.A. under the strategic collaboration for anticancer agent Lenvima, which were 22.2B yen in 1H FY2018,none in 1H FY2019. *6: Includes the amount of profits and expenses shared with partners under strategic collaborations, the amount of shared profit for Lenvima paid by Eisai to Merck & Co., Inc., Kenilworth, N.J., U.S.A. (7.9B yen in 1H FY2018, 22.8B yen in 1H FY2019), and gain on sales of shares of subsidiary company

Revenue of Major Products


Results % Results % YoYLenvima 24.5 100.0 50.5 100.0 207 [212]Japan 4.3 17.8 6.9 13.7 159 [159]Americas 14.4 58.9 28.4 56.1 197 [200]China 7.1 14.1EMEA 3.7 15.2 5.8 11.5 156 [167]Asia and Latin America 2.0 8.1 2.3 4.6 118 [122]

32

Halaven 20.4 100.0 20.6 100.0 101 [104]Japan 4.9 24.1 5.0 24.3 102 [102]Americas 8.1 39.6 7.5 36.4 93 [94]EMEA 6.1 30.1 7.1 34.5 116 [123]Asia and Latin America 1.3 6.2 1.0 4.7 77 [79]

Fycompa 9.2 100.0 11.8 100.0 128 [132]Japan 1.4 15.2 1.9 16.4 139 [139]Americas 4.5 48.2 6.0 50.6 134 [137]EMEA 3.0 32.0 3.4 28.5 114 [122]Asia and Latin America 0.4 4.6 0.5 4.5 125 [131]


[ ] based on local currency

April-September 2018 April-September 2019Results % Results % YoY

Revenue 145.4 100.0 125.8 100.0 87Prescription medicines 133.2 91.6 125.8 100.0 94

Humira 23.9 16.4 25.3 20.1 106Lyrica*1 13.8 9.5 13.9 11.1 101Aricept 9.8 6.7 7.4 5.9 76Methycobal 7.8 5.4 7.4 5.9 95Lenvima 4.3 3.0 6.9 5.5 159Lunesta 5.5 3.8 6.3 5.0 114Pariet*2,3 6.8 4.7 5.8 4.6 85Halaven 4.9 3.4 5.0 4.0 102Treakisym 3.7 2.5 4.1 3.3 113Elental*2 3.3 2.3 3.3 2.6 101Careram 2.0 1.4 3.2 2.6 159Fycompa 1.4 1.0 1.9 1.5 139

Generics 12.2 8.4 - - -Segment profit 57.3 39.4 50.3 40.0 88

33

Performance of Japan Pharmaceutical Business


Effective from this fiscal year, aiming for more flexible strategy execution, the Group separated OTC and others from Japan pharmaceutical business, to newly establish the OTC and others business. The financial results in the corresponding period of the previous fiscal year disclosed in the following reporting segments reflect this change of the reporting segments. *1: Alliance revenue *2: EA Pharma product *3: Includes sales of triple formulation Helicobacter pylori eradication packs, Rabecure Pack 400/800 and Rabefine Pack



Revenue 42.8 100.0 57.9 100.0 135 [137]

Lenvima 14.4 33.7 28.4 49.0 197 [200]

Banzel 8.5 19.8 11.5 19.9 136 [138]

Halaven 8.1 18.9 7.5 13.0 93 [94]

Fycompa 4.5 10.4 6.0 10.3 134 [137]

BELVIQ 1.9 4.5 2.0 3.5 104 [106]

AcipHex 2.2 5.0 2.0 3.5 93 [95]

Segment profit 16.9 39.5 30.6 52.9 181 [184]

34



Performance of Americas Pharmaceutical Business



Revenue 31.8 100.0 44.7 100.0 140 [150]

Methycobal 10.4 32.8 12.5 27.9 120 [128]

Lenvima 7.1 15.9

Aricept 4.9 15.3 5.9 13.2 121 [129]Stronger Neo-Minophagen C and Glycyron Tablets 5.1 16.2 5.4 12.0 104 [111]

Pariet 2.9 9.1 3.5 7.8 120 [128]

Segment profit 11.5 36.2 21.5 48.2 187 [204]

35

Performance of China Pharmaceutical Business





Revenue 25.4 100.0 26.1 100.0 103 [109]

Halaven 6.1 24.2 7.1 27.3 116 [123]

Lenvima / Kisplyx 3.7 14.6 5.8 22.3 156 [167]

Fycompa 3.0 11.6 3.4 12.9 114 [122]

Zebinix 2.8 10.9 3.1 12.0 113 [121]

Zonegran 2.0 7.9 2.0 7.7 100 [107]

Inovelon 1.1 4.5 1.2 4.6 104 [111]

Segment profit 11.2 44.0 11.7 45.0 105 [111]

36



Performance of EMEA Pharmaceutical Business



Revenue 24.7 100.0 24.0 100.0 98 [102]

Aricept 6.1 24.6 5.5 22.8 91 [96]

Humira 6.6 26.9 5.4 22.6 82 [88]

Lenvima 2.0 8.1 2.3 9.8 118 [122]

Pariet 1.9 7.8 2.1 8.8 109 [112]

Methycobal 1.8 7.4 1.5 6.1 80 [81]

Halaven 1.3 5.2 1.0 4.1 77 [79]

Fycompa 0.4 1.7 0.5 2.2 125 [131]

Segment profit 8.5 34.4 9.0 37.4 106 [111]

37



Performance of Asia and Latin America Pharmaceutical Business

Performance of OTC and Others in Japan

Effective from this fiscal year, aiming for more flexible strategy execution, the Group separated OTC and others from Japan pharmaceutical business, to newly establish the OTC and others business. The financial results in the corresponding period of the previous fiscal year disclosed in the following reporting segments reflect this change of the reporting segments. *1: Vitamin B preparation, “Chocola BB Plus” and others.38



Revenue 12.3 100.0 13.1 100.0 107Chocola BB Group*1 8.0 64.9 8.5 65.0 107

Segment profit 2.7 22.3 3.4 26.1 125


Overview of Anti-A-beta AntibodyClinical Trial Designs

Drug(Sponsor)

Study name(Stage)

Target population(Estimated enrollment) Dose Inclusion criteria

(partial)Efficacy measurement

(Primary endpoints)

BAN2401*1

(Eisai, Biogen) Clarity AD (Phase III) Early AD(1566)

10mg/kg biweeklyPlacebo

MCI due to AD, mild AD (NIA-AA), CDR: 0.5, CDR memory box ≧0.5,

Amyloid positive, MMSE≧22,WMS-IV LMII: 1 SD below age-adjusted mean

CDR-SB(18 months)

Aducanumab(Biogen, Eisai)

ENGAGE (Phase III) Early AD (1605) Low doseHigh dosePlacebo

MCI due to AD or mild AD CDR-Global Score: 0.5,

MMSE≧24, Amyloid positive

CDR-SB (78 weeks)EMERGE (Phase III) Early AD (1605)

Gantenerumab(Roche)

SCarlet RoAD*2,3

(Phase III)Prodromal AD

(799)

105mg, 225mg,Up to 1200mg

Placebo

MMSE≧24, Prodromal AD who are not receiving memantine or cholinesterase inhibitors

CDR-SB (104 weeks)

Marguerite RoAD*3

(Phase III) Mild AD (389)Gantenerumab

Placebo

Clinical diagnosis of probable mild AD(NINCDS/ADRDA), Amyloid-beta positive in CSF

ADAS-Cog13 (104 weeks),ADCS-ADL (104 weeks)

Graduate I (Phase III) Early AD (760) Probable AD dementia or prodromal AD (NIA-AA), Amyloid positive, MMSE≧22, CDR-GS: 0.5 or 1.0

CDR-SB (104 weeks)Graduate II (Phase III) Early AD (760)

Crenezumab(Roche, Genentech)

CREAD 1*4 (Phase III) Prodromal to mild AD (813) Crenezumab

Placebo

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

CDR-GS 0.5 or 1.0, A-beta positive

CDR-SB(105 weeks)

CREAD 2*4 (Phase III) Prodromal to mild AD (806)

Phase II Preclinical AD (252) Crenezumab, placebo PSEN1 E280A mutation carrier kindred

MMSE≧24 (for ≧ 9 years of education) or MMSE≧26 (for ≦ 9 years of education), not meet the

criteria for dementia due to AD, MCI due to AD

API ADAD Composite Cognitive Test Total Score

(260 weeks)

Phase II Preclinical AD (150)Crenezumab,

placebo, PET ligand ([18F]GTP1 )

Tau distribution measured by SUVR by [18F]GTP1 tau PET scan (130, 260weeks)

Solanezumab(Eli Lilly)

A4(Phase III)

Preclinical AD*5

(1150)Solanezumab

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

Amyloid positivePACC

(240 weeks, 366 weeks)

Gantenerumab,Solanezumab

(Washington University School of Medicine)

DIAN-TU(Phase II/III)

Preclinical AD*6

(490)

Gatenerumab Solanezumab

Placebo

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

chance of having ADAD mutation, Cognitively normal or with mild cognitive impairment or mild dementia,

CDR: 0-1

DIAN-TU cognitive composite score (52, 104,

156, and 208 weeks)

LY3002813/Donanemab

(Eli Lilly)

TRAILBLAZER-ALZ (Phase II)

Prodromal to mild AD (266)

Donanemab,Placebo

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

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

39

Study designs for Phase II and beyond in this chart was created by Eisai based on the information on ClinicalTrials.gov as of October 3, 2019. Studies shown here include those discontinued in the past 2 years. All projects are investigational. *1: Eisai licensed in from BioArctic *2: Roche announced discontinuation of SCarlet RoAD study on December 19, 2014 on their press release *3: FPI in OLE study was announced at Roche Nine Months 2016 Sales Conference Call on October 20, 2016 *4: Roche announced discontinuation of CREAD 1 and CREAD 2 study on January 30, 2019 on their press release *5: Target population for this trial is older individuals who may be at risk for memory loss *6: Target population for this trial is individuals at risk for or with a type of early onset Alzheimer's disease caused by a genetic mutation

All projects are investigational except for the Lenvima + KEYTRUDA® combo for EC. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A. Projects for LENVIMA are under joint development with Merck & Co., Inc., Kenilworth, N.J., U.S.A. The LEAP studies are led and were submitted by Merck & Co., Inc., Kenilworth, N.J., U.S.A. 1L: First line 2L: Second line. * Not Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation

Of the planned 13 studies for the combination therapy with KEYTRUDA®, 11 studies have been initiated, and the remaining 2 studies are planned to be initiated within FY2019

40

Endometrial carcinoma 2L*Approved in September 2019

Phase I/II Study 111

The first combination therapy with KEYTRUDA®

to receive simultaneous review decisions in the U.S., Australia and Canada

Progress of Development for Combination Therapy with KEYTRUDA®

Renal cell carcinoma 1LPhase III initiated in October 2016

Study 307

Endometrial carcinoma 1LPhase III initiated in April 2019

LEAP-001

Endometrial carcinoma 2LPhase III initiated in June 2018

Study 309

Basket trial in multiple cancer types:Triple-negative breast cancer

Gastric cancerOvarian cancer

Colorectal cancerGlioblastoma

Biliary tract cancersPhase II initiated in February

2019LEAP-005

NSCLC1LNon-squamous cell carcinoma

Combination with chemotherapyPhase III initiated in March 2019

LEAP-006

NSCLC 1LPD-L1 positive

Phase III initiated in March 2019LEAP-007

NSCLC 2LPhase III initiated in June 2019

LEAP-008

Head and neck cancer 1L

Head and neck cancer 2L

Urothelial carcinoma 1LPhase III initiated in May 2019

LEAP-011

Melanoma 1LPhase III initiated in March 2019

LEAP-003

Melanoma 2LPhase II initiated in January 2019

LEAP-004

Hepatocellular carcinoma 1LPhase III initiated in December

2018LEAP-002★

★ Breakthrough Therapy designation by the U.S. FDA

★

★

Receipt of Payments fromMerck & Co., Inc., Kenilworth, N.J., U.S.A.

FY2018 1H results

41

No receipt of milestone payments

Milestone payment associated with the

reimbursement approval in EU

25 million USD(2.8 billion yen)

Milestone payment associated with the approvals of

hepatocellular carcinoma indication in the U.S. 125 million USD(13.9 billion yen)

Milestone payment associated with the approvals of

hepatocellular carcinoma indication in EU


Milestone payment associated with the approvals of hepatocellular carcinoma indication in China


FY2018 2H results

One-time option payment associated with certain

option rights325 million USD(35.0 billion yen)

Sales-based milestone payment anticipated when annual

revenue of 500 million USD is achieved


Total 600 million USD (65.5 billion yen) in FY2018

* Calculation based on 1USD=105 yen

FY2019 1H results FY2019 2H forecast200 million USD (21.0

billion yen*) +recognition of milestone

payments and others

One-time option payment associated with certain

option rights200 million USD(21.0 billion yen*)

Recognition of multiple sales-based milestone

payments and regulatory milestone

payment are expected

q2 fy2019 (fiscal year ending march 31, 2020) …demography of dementia 5 0 50 100 150 20.4 22.6...

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