fy2016 (fiscal year ended march 31, 2017) financial ... · pdf filefy2016 (fiscal year ended...

FY2016

(Fiscal Year Ended March 31, 2017)

Financial Results Presentation

May 10, 2017

Eisai Co., Ltd.

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

FY2016

Plan ‘EWAY 2025’ inaugurated

Business portfolios clarified

2

Fields where innovation to be focused

Neurology Business Group Dementia field

Oncology Business Group Cancer microenvironment field

Cancer informatics field*

EA Pharma Inflammatory bowel disease field

Field specialization objectives

1. Productivity of pipeline and business is improved through

Early Decisions made by an organization where Discovery,

Clinical and Commercial functions are integrated.

2. Scientific Acumen, an important organizational culture,

is developed through an integrated business structure

including Discovery.

* A field of drug development aiming at precision medicine with potential for shorter development timeline and smaller-scaled clinical studies utilizing strength in human

biology informatics, an library for small molecules including natural products, and research to find biomarkers for aberrant splicing in relevant to cancer with competitive

advantage and gene mutation

(billions of yen, %)

3

FY2016 Consolidated Statement of Income (IFRS)

Achieved increase in profit and secured financial integrity

FY2016 average exchange rates:

USD 1: 108.38 yen (-9.8% YoY), EUR 1: 118.78 yen (-10.4% YoY), GBP 1: 141.59 yen (-21.9% YoY), RMB 1: 16.10 yen (-14.6% YoY)

*1: The result excluding the effects of foreign exchange fluctuations (Calculated converting FY2016 cumulative result into yen by YoY average exchange rates)

*2: Net Debt Equity Ratio= (Interest-bearing debt (corporate bonds and loans)- Cash and cash equivalents - Time deposits exceeding 3 months)/

Equity attributable to owners of the parent

FY2015 FY2016

Results % Results % YoYYoY

Based on local currency*1

Revenue 547.9 100.0 539.1 100.0 98 104

Cost of sales 194.5 35.5 195.9 36.3 101 104

Gross profit 353.5 64.5 343.2 63.7 97 104

R&D expenses 122.3 22.3 112.5 20.9 92 99

SG&A expenses 192.8 35.2 179.7 33.3 93 100

Other income & expenses 13.6 2.5 8.0 1.5 59 60

Operating profit 51.9 9.5 59.1 11.0 114 116

Profit for the year 55.0 10.0 42.2 7.8 77 79

Profit for the year(Attributable to owners of the parent)

54.9 10.0 39.4 7.3 72 74

ROE (%) 9.4 6.8

End of March 2016 End of March 2017

Net DER*2 0.01 (0.05)

Free cash flow 81.1 82.0

4

Growth in Main Business

1. Revival of Japan Business

2. Growth in All Regions

3. Momentum of Global 4 Brands

Revival of Japan Business

Provide evidence-based solutions for issues that patients and local communities are facing, based on clinical

questions we found out at 91 towns/cities*5

where Eisai has partnership agreements for collaboration in dementia

Continuously launch tools to provide solutions

Interprofessional collaboration service Hikari One Team SP (Service commenced in July 2016, launched by NTT IT),

administration support device “e-OKUSURI-SAN” (January 2017), olfactory test “UPSIT” (April 2017) and tracking tool to

support elderly people going out “Me-MAMORIO” (under development)

*1: 13 branded drugs including the products designated by MHLW as Premium to promote the development of new drugs and eliminate off-label use: Halaven, Lenvima, Fycompa, Humira,

Lunesta, Maxalt, Fostoin, Careram, Inovelon, NerBloc, Gliadel, Treakisym and Lyrica (alliance revenue) *2: Revenue of 13 branded drugs/revenue of prescription medicines excluding EA Pharma products

*3: Co-development with Mochida Pharmaceutical Co., Ltd *4: Co-development with Kissei Pharmaceutical Co., Ltd. *5: As of April 26, 2017

58%

51%

Outperformed the Japan market growth in Q4 FY2016

Ratio of branded drugs*1 to revenue*2 achieved over 50%

Growth of Halaven, LENVIMA, Fycompa, Humira and Lunesta contributed

hhc solutions business: Support to establish a social systemwhich enables dementia patients to live safely and with peace of mind in their community

Japan business

revenue forecast

*6

5

EA Pharma: Steady progress of development pipeline mainly in inflammatory bowel disease field AJG533 (elobixibat)*3 Chronic constipation treatment: Submitted in February 2017

AJG511 (budesonide)*4 Ulcerative colitis treatment: Submitted in October 2016

Pariet Maintenance therapy for proton pump inhibitor resistant reflux esophagitis: Submitted in October 2016

AJM300 (carotegrast methyl)*4 Ulcerative colitis treatment: Phase III study ongoing E6007 Ulcerative colitis treatment: Phase II study ongoing

E6011 Anti-fractalkine antibody: Phase II study ongoing for primary biliary cholangitis

Phase I/II study ongoing for Crohn’s disease E6130 Inflammatory bowel disease treatment: Phase I study ongoing

43%

51%

58%

2015年度

実績

2016年度

実績

2017年度

見通し

売上収益

新薬創出等加算品目等

対売上収益比率

FY2015

Results

FY2016

Results

Revenue

Eisai Japan

Ratio of branded

drugs to revenue*2

284.9Byen

293.0BYen

(101%

YoY)

291.1Byen

Halaven: Achieved re-education of physicians about Halaven’s efficacy in patients with HER2-negative hormone-positive recurrent metastatic breast cancer

LENVIMA: Contributed to over 2,000 thyroid cancer patients in total since its launch in May 2015

Fycompa: Contributed to over 4,000 epilepsy patients in total since its launch in May 2016

Aim for further growth by leveraging administration restriction lift anticipated in June 2017

Humira: Achieved success in joint promotion with approx. 440 sales reps of EA Pharma for inflammatorybowel disease field, such as ulcerative colitis and Crohn’s disease

Approved for double-dose treatment in patients with moderate or severe Crohn’s disease in June 2016

Lunesta: Established position as a proper insomnia treatment for elderly people with its lower risk of falls and bone fractures

Eisai Japan

(102%

YoY)

FY2017

Forecast

Aiming to outperform the market in FY2017

All projects are investigational

6

*1: The impact of foreign exchange fluctuations are excluded for the figures in the brackets (calculated FY2016 YTD performance based on the average exchange rate of FY2015)*2: The influence of risks relating to the patent infringement litigation for antiemetic agent Aloxi in the United States announced on May 3, 2017 has not been included. *3: Methycobal, Aricept, Stronger Neo-Minophagen C/Glycyron and Pariet *4: Europe, Middle East, Africa, Russia and Oceania *5: Gemeinsame Bundesausschuss

(German Federal Joint Committee) *6: National Institute for Health and Care Excellence *7: Aricept, Pariet and Methycobal

Growth in All Regions

Aim to achieve double-digit growth in 4 overseas regions

◆Growth of LENVIMA (190% YoY), Halaven (101% YoY) and

Fycompa (152% YoY)

◆Fycompa: FDA confirmed receipt of submission of

monotherapy for partial-onset seizures (investigational)in December 2016

◆BELVIQ: Launched once daily formulation in October 2016

Americas

<FY2016 achievement*1>

<FY2017 forecast>

◆Growth of global brands

LENVIMA 156% YoY, Halaven 111% YoY

Fycompa 181% YoY , BELVIQ 135% YoY

China

AsiaEMEA*4

Revenue: 132.0B yen (113% YoY)*2

Revenue: 38.0B yen (109% YoY)Revenue: 44.5B yen (118% YoY)

◆Achieved double-digit growth in Methycobal, Aricept and Pariet

Methycobal (112% YoY), Aricept (130% YoY), Pariet (141% YoY)

◆Penetration in Low Tier Market: Coverage expanded to approx. 150

cities

◆Achieved 9 product launches of high-quality generics by

Eisai (Liaoning) Pharmaceutical Co., Ltd.

Revenue: 54.0B yen (110% YoY)<FY2017 forecast>

◆Continuous growth of 4 major products*3 centered around Methycobal

◆Accelerated growth in Low Tier Market

◆Approval anticipated for additional indication of severe AD for Aricept

◆Accelerated contribution to patients with Parkinson‘s disease with

Comtan and Stalevo

◆Growth of Halaven (116% YoY) and Fycompa (424% YoY) in

addition to 3 major products*7

◆Expansion of LENVIMA launch (Thailand, Taiwan and Singapore)

◆Steady growth in South Korea (114% YoY) and Taiwan

(115% YoY) where Universal Healthcare Coverages (UHC) are

established

◆Halaven was provided to 1,020 patients (162% YoY) through

the patient assistance program (PAP) in India and other countries

where UHC has yet to be established

<FY2017 forecast>◆Growth of global brands (LENVIMA, Halaven and Fycompa)

◆Growth in Indochina (Vietnam, Myanmar, Cambodia and Laos)

◆ Growth of LENVIMA (336% YoY) and Fycompa (133% YoY)

◆ LENVIMA: G-BA*5 confirmed the additional benefit of Kisplyx inthe treatment of advanced renal cell carcinoma (RCC)

◆ Halaven: NICE*6, UK recommendation for treatment of advancedbreast cancer (3rd line)The first breast cancer treatment to be recommended by NICE since 2007

<FY2017 forecast>

◆Growth of global brands

LENVIMA 181% YoY, Halaven 123% YoY, Fycompa 153% YoY



< FY2016 achievement*1>

<FY2016 achievement*1><FY2016 achievement

*1>

7

Growth of Global 4 Brands

0

20

40

60

80

100

120

FY2015 Results FY2016 Results FY2017 Forecast

40.2 37.3 43.0

11.5 21.5

33.0 7.6

10.3

20.5

4.4

3.7

5.0 BELVIQ

Fycompa

LENVIMA

Halaven

(billions of yen)

72.8B yen

114% YoY(Local currency base*: 126% YoY)

101.5B yen


Percentage of global 4

brands in total revenue11.6% 13.5% 17.6%

63.6B yen


* The impact of foreign exchange fluctuations are excluded

8

*1 : Indications vary in each country or territory. Unresectable or recurrent breast cancer in Japan, 3rd-line+ therapy for locally advanced or metastatic breast cancer in the US, and 2nd-line+ therapy for locally advanced or metastatic breast cancer in EU.*2: Approved indication in U.S. and EU: advanced liposarcoma. Approved indication in Japan: soft tissue sarcoma

*3: The impact of foreign exchange fluctuations are excluded. *4: Renal cell carcinoma. *5: The RCC indication in the US and EU: in combination with everolimus in advanced RCC following one prior anti-angiogenic (VEGF) therapy *6: Investigational

Establish strong position and increase awareness in breast cancer chemotherapy market through Halaven’s MOA

National Comprehensive Cancer Network (NCCN) recommended Halaven in Category 1 in December 2016

Approx. 780 patients with soft tissue sarcoma treated with Halaven in Japan since its launch

Halaven revenue

FY2016 results FY2017 forecast

Asia

Japan

EMEA

Americas

37.3B yen93% YoY

(Local currency base*3:

102% YoY)

43.0B yen115％ YoY


112% YoY)

Soft tissue

sarcoma

Breast cancer

The only chemotherapy confirmed to prolong overall survival (OS) as monotherapy in multiple

large-scaled clinical studies in metastatic breast cancer*1

and advanced soft tissue sarcoma*2

Momentum of Global Brands

Aiming at expansion of contribution to patients with thyroid cancer and RCC*4

and early development of combination therapies

LENVIMA revenue

2nd line combination therapy with everolimus*5

Approved in US in May 2016 and in EU in August 2016National Comprehensive Cancer Network (NCCN) recommended LENVIMA in Category 1 in the guideline in September 2016

1st line*4,6

: Initiated Phase III study of combination therapies; “lenvatinib+pembrolizumab” and “lenvatinib+everolimus” in September 2016Aim to obtain topline results in FY2019


AsiaJapanEMEAAmericas

Aim for further growth as realized 1st line therapycapable of fast, superior clinical effects over long term

RCC*4

Thyroid cancer

Phase Ib/II studies ongoing for patients with RCC, endometrial cancer, melanoma, head and neck squamous-cell carcinoma (HNSCC), urothelial cancer, and non–small cell lung cancer

Patient enrollment following additional endometrial cancer cohort currently on target

Aim for potential launch after FY2020

Combination

therapies with

pembrolizumab*6

21.5B yen187% YoY


205% YoY)

33.0B yen154％ YoY


148% YoY)

Steady progress in development of monotherapy*1

for partial-onset seizuresUS: PDUFA action date: July 26, 2017

Europe: Received positive opinion from CHMP*2 in February 2017 in regards to

include additional data on monotherapy in SmPC*3

Japan: Initiated Phase III study in April 2017

(Historical control open study*5 with 80 patients planned)

Initiatives aimed at indication expansion

Pediatric indication*1: Phase III study ongoing and Lennox-Gastaut syndrome

*1: Phase III study ongoing

Fycompa administration restriction lift in JapanLeverage upcoming June 2017 administration restriction lift and utilize accumulated real-world

evidence with the aim of rapidly expanding Eisai’s contribution to patients



Asia

Japan

EMEA

Americas

9

Momentum of Global Brands

Leverage acquisition of worldwide commercialization and supply rights to achieve a return to growth for BELVIQ

Agreement reached with Arena in December 2016 to revise commercialization

and supply agreement

Acquired all global development and commercialization rights

Increase revenue outside the Americas through partners*6

Expand utilization of once-daily formulation for further growth in US

Fycompa revenue

BELVIQ revenue

Leverage planned milestone events to maximize growth

*1: Investigational *2: Committee for Medicinal Products for Human Use *3: Submission of the Type-II variation for conversion to monotherapy described in Section 5.1 of

SmPC *4: Excluding impact of foreign exchange fluctuations *5: Single-arm, open trial to evaluate efficacy comparing to the past efficacy data as a reference

*6: South Korea

10.3B yen137% YoY


152% YoY)

20.5B yen199％ YoY


193% YoY)

3.7B yen84% YoY


93% YoY)

5.0B yen135％ YoY


129% YoY)

10

Progress in dementia field

1. Establishment of

New Paradigm

2. Steady progress of pipeline

11

Anti-tau antibodyAD/dementia

New mechanism of

action

Lemborexant*1

ISWRD*2 associated with

AD/dementia

Orexin receptor

antagonist

E2027Behavioral/cognitive

disorder due to Lewy body disease/dementia

PDE9 inhibitor

Aducanumab*3

Early ADAnti-amyloid-beta

antibody

Elenbecestat*4,5

Early AD BACE inhibitor

E6011AD/dementia

Anti-fractalkine

antibody

EphA4Synapse

modulator

E2082Epilepsy

Next generationAMPA receptor

antagonist

E2730Epilepsy

New mechanism of action

All projects are investigational *1: Co-development with Purdue Pharma *2: Irregular sleep-wake rhythm disorder *3: Under development by Biogen. Eisai has an option to

jointly develop and commercialize *4: Co-development with Biogen. *5: Generic name for E2609. The generic name is pending final approval at this time.

New Paradigm for Medicine Creation

in Dementia Field

Three pillars

A-beta Tau Reactive glial cell

Intracerebral clearance enhancer

by reinforcing protective

mechanism

Brain homeostasis improving agent

targeting astrocyte

Neural stem cell activation

agent

Sleepdisorder

Behavioraldisorder

Cognitivedisorder

Ideation Stage

Transformation of

symptoms over time

Progress of aggressive

factors accumulation

Brain maintenance

system

Genetic background Protective

mechanismEnvironmental factor

BAN2401*4

Early AD Anti-amyloid-beta

protofibrils antibody

12

*1: Generic name for E2609. The generic name is pending final approval at this time. *2: Investigational. Co-development with Biogen

*3: Names for Phase III studies (AD1 refers to Study 301 and AD2 to Study 302) *4: Clinical Trial Authorization *5: Sources: (1) Jonsson, T. et al. (2012) “A mutation in APP

protects against Alzheimer’s disease and age-related cognitive decline. Nature 488; 96-99 (2) Maloney, J.A. et al. (2014) “Molecular mechanisms of Alzheimer disease

protection by the A673T allele of amyloid precursor protein.” J Biol Chem 289; 30990-31000

Medicine creation targeting the accumulation of aggressive factors

Accelerated Development of Elenbecestat*1,*2

Phase III studies (MISSION AD1 and MISSION AD2)*3 ongoing

US: Initiated in October (AD1) and December (AD2) 2016

Japan: Initiated in March 2017

EU: Plan to initiate in Q1 FY2017

China: CTA*4 filed in April 2017

Topline results of MISSION AD1 and MISSION AD2

anticipated in FY2020

Elenbecestat(BACE inhibitor)

Target A-beta positive early AD patients (MMSE≧24)

Select CDR-SB as a sensitive tool for early AD patients

Selected optimal single dose of 50 mg based on the evidence

of human biology*5 and PK/PD data of Phase I and II studies

Clinical study design with keys to seek higher probability of success

Right patient target

Optimal endpoint

Optimal dose setting

Plan to implement clinical studies at over 60 sites in Japan

Clinical studies with Eisai’s advisory board members’ support

Contribution of medical experience in dementia field

in Japan

13

Medicine creation targeting the accumulation of aggressive factors

Accelerated Development of Anti-A-beta Antibodies

*1: Investigational. *2: Co-developed with Biogen *3: Interim analyses anticipated at 3, 6, and 9 months after 800th patient randomized, respectively. Interim analysis criteria

for early success based on Bayesian adaptive design; the probability of at least one dose having ≥25% difference in ADCOMS from placebo is >= 95% after 12 months

treatment *4: Independent Monitoring Committee *5: Alzheimer’s Disease Composite Score (ADCOMS) Bayesian Analysis *6: Secondary endpoints (3 items), namely,

ADCOMS at month 18; total hippocampal volume utilizing vMRI at months 6, 12, and 18; and amyloid level in brain utilizing amyloid PET imaging at months 12 and 18

*7: Under development by Biogen. Eisai has option to jointly develop and commercialize

Phase III studies (ENGAGE, EMERGE) ongoingAducanumab*1,*7

(Anti-A-beta antibody)

April 2017: Conducted interim analysis*3 six months after 800 patients randomized

IMC*4 recommended continuation of the study

Q3 FY2017(12 months after 856 patients randomized): Topline results for primary endpoint*5 anticipated

FY2018(18 months after 856 patients randomized): Results of full data analysis (secondary endpoints*6)

anticipated

Large-scaled Phase II study with 856 patients underwayBAN2401*1,*2

(Anti-A-beta protofibrils antibody)

Target A-beta positive early AD patients (MMSE≧22)

Select in-house developed evaluation index, ADCOMS as an endpoint

to seek higher sensitivity to early AD patients

Adoption of Bayesian adaptive design, which potentially enables Eisai

to find out the optimal dose and administration from 6 different dose/

administration arms, including a placebo arm

Right patient target

Optimal endpoint

Optimal dose setting

Clinical study design with keys to seek higher probability of success

With the assistance of regulatory agencies, explore how to leverage ongoing Phase II study

in future pivotal program provided the Phase II study achieves positive outcome

14

Medicine creation targeting transformation of symptoms over time

Accelerated Development of Lemborexant*1

ISWRD*3 associated with AD/dementia

Insomnia Aim for best-in-class insomnia agent suitable for elderly patients

Obtained favorable data for lemborexant versus zopiclone*2 and placebo

Lemborexant*1

Orexin receptor

antagonist

Phase II study targeting AD patients ongoing Topline results anticipated in FY2017

Study 106 (Driving study)The study to evaluate drug effect on the ability on driving.

Endpoint is measured with the standard deviation of lateral position (SDLP)

Sleep disorder Behavioral disorder Cognitive disorder

Two Phase III studies ongoing・Study 304: Controlled study with active comparator (zolpidem)

Topline results anticipated in FY2017・Study 303: 6-month, long-term placebo-controlled study

Aim for first-in-class treatment agent for ISWRD in patients with AD/dementia

*1: Investigational. Co-development with Purdue Pharma *2: Control drug *3: Irregular sleep–wake rhythm disorder

15

Potential to Delay the Onset of Dementia through Suppressing

Behavioral Disorder Symptoms

Novel findings and Eisai’s approach

toward clinical relevance between epilepsy and dementia

*1: Lancet Neurology (2017)16, 311-322, Keith A. Vossel, et al *2: Neuroscience 286 (2015) 251-263, H.A. BORN *3: Investigational

Neuronal hyperexcitability potentially occurs in early AD patients, similar to epilepsy

and potentially accelerates decline of cognitive function when epileptic seizure

occurred in AD patients*1

A-beta (an aggressive factor for the onset of AD) or APP (precursor of A-beta)

induces electrical imbalances in the brain, which potentially induces epilepsy and

seizures*2

Hypothesis

APP and A-beta ⇒ Neuronal hyperexcitability ⇒ epileptic seizure and the onset of AD

Initiated Phase I study

in February 2017

Epilepsy and other

neurological disordersE2730*3

New mechanism

of action

E2082*3

Next generation AMPA

receptor antagonistIND submission

planned in FY2017

Epilepsy and other

neurological disorders

Sleep disorder Behavioral disorder Cognitive disorder

Currently published research papers suggested epilepsy and the physiology associated with epilepsy is clinically relevant to AD

16

Progress in oncology field

1.

Hepatocellular carcinoma

(HCC)* potential

2. Steady progress of

pipeline

* Investigational and not approved

17

Annual number of new patients diagnosed

with liver cancer worldwide:

780,000*2

Highest in Asia, including China and Japan,

representing approx. 80%*2

HCC represents the highest incidence in all liver

cancer, accounting for approx. 85% to 90% in

primary liver cancer*2

Median OS of patients with progressive HCC:

Less than 12 months

Unmet Medical Needs Remain in Treatment for HCC*1

Lung cancerLiver cancerStomach cancerColorectal cancerBreast cancerEsophageal cancerPancreas cancerOther

Mortality*2

*1: Hepatocellular carcinoma. Investigational and not approved.

*2: Source: GLOBOCAN2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012. http://globocan.iarc.fr/

*3: Internal estimates based on Decision resources and other data

*4: Japan, US and EU 5 (UK, France, Germany, Italy and Spain) *5: Brazil, China(city areas), India (city areas), Mexico, Russia, South Korea and Turkey

19.4%

9.1%

8.8%

8.5%6.4%4.9%

4.0%

39.0%

Liver cancer ranking among other cancer-

related deaths:

2nd highest overall

80,000

90,000

100,000

110,000

2015 2020 2025 2030

Developed countries

Number of diagnosed patients are

increasing worldwide

Etiology: hepatitis B virus, hepatitis C

virus and cirrhosis due to alcohol abuse

Current research shows increasing

trend of non-B non-C

hepatocellular carcinoma*2

(number of

patients)

Transition of number of patients diagnosed

for hepatocellular carcinoma*3

270,000

300,000

330,000

2015 2020 2025 2030

Emerging countries(number of

patients)*4 *5

Approx.

90,000

Approx.

110,000

Approx.

290,000

Approx.

320,000

HCC 1st line monotherapy

18

Achieved primary endpoint in Phase III study

*1: Hepatocellular carcinoma. Investigational and not approved.

*2: The American Society of Clinical Oncology. The 2017 ASCO Annual Meeting will be held on June 2 to June 6 at Chicago, US.

Oral presentation is scheduled on June 4.

“Phase III trial of lenvatinib (LEN) vs sorafenib (SOR) in first-line treatment of patients (pts)with unresectable hepatocellular carcinoma (uHCC)”

Aim to establish as the standard treatment for HCC*1

Five most common adverse events observed in the lenvatinib arm: hypertension, diarrhea, decreased appetite,

weight loss and fatigue, which is consistent with the known side-effect profile of lenvatinib

Met the statistical criteria for non-inferiority of OS

compared to sorafenib, and showed statistically significant and clinically

meaningful improvement for PFS, TTP and ORR

The HCC results will be shared via an oral presentation at ASCO*2

Submission plan Japan in June 2017 US and Europe in July 2017 China in 2H FY2017

19

H3B-6545First-in-class, estrogen

receptor 1 (ESR1) covalent

antagonist

H3B-8800Splicing modulator with

chemical structure combined

with natural derived products

Phase I study ongoing

H3B-6527

FGFR4 inhibitor

Phase I study ongoing

Medicine Creation at H3 Biomedicine

Accelerate development in cancer informatics area

Aberrant splicing

Driver gene mutation

Driver gene mutation

Drug resistance mutation

All projects are investigational *1: Internal estimates *2: J Clin Oncol. 1984 Oct;2(10):1102-9. *3: Curr Oncol Rep. 2017 May;19(5):35

*4: Presented at American Association for Cancer Research (AACR) Abstract number: DDT01-04

Frequency of spliceosome gene

mutation is approx. 50% to 60%*1

in chronic myelomonocytic

leukemia (CMML), : Aim for new

treatment option for patients with

hematological malignancies

Overexpression of driver gene

FGF19 (FGFR4 ligand) in approx.

35%*1

of hepatocellular carcinoma

(HCC) patients: Aim for new

treatment option for patients with

HCC with activated FGFR4

pathway

Approx. 70% of breast cancer is

estrogen receptor (ER) positive*2

ER mutation is found in 25 to 40%

of endocrine resistant metastatic

breast cancer*3

Shows activity in not only

wild-type ESR1, but also mutant

ESR1, which is potentially associated

with endocrine therapy resistance*4

Potential to contribute to patients

with ER positive breast cancer

Aim to launch by FY2020 Aim to launch by FY2020Plan to initiate Phase I

study in FY2017Aim to launch shortly after FY2020

Novel ADC with potential against overexpressed folate receptor alpha cancer types.

Three keys in MOA, with unique payload derived from natural products; internalized in the cell, can

cleave the linker enzymatically in the cell, and does not form

aggregates

20

Eisai’s First Antibody-Drug Conjugate (ADC) Project

Collaboration of Eisai’s strength in chemistry

and Morphotek’s antibody technology

MORAb-202*1ADC: Combination of in-house developed antibody, farletuzumab, which is currently in clinical development stage and eribulin, a compound developed

with advanced organic synthesis technology

Bind 4 eribulin

Plan to initiate Phase I study in FY2017

(target cancer types, including metastatic triple-negative breast cancer

in expansion cohort in consideration)

*1: Investigational *2: The agent to bind antibody through linker

LinkerAntibody Payload*2

eribulinfarletuzumab

• Unique mode of action of natural derived products targeting cancer micro environment

• Does not form aggregates due to its high water solubility

cleaved byenzyme in the cell

Farletuzumab is

internalized

in the cellMORAb-202

Linker

Non-clinical data showed

potentially favorable data in

efficacy and safety with

approx. 1/5 the extrapolated

clinical dosage

21*1: Neglected tropical diseases *2: diethylcarbamazine

*3: Cambodia, Cook Islands, Niue, Vanuatu, Marshall Islands, Sri Lanka, Maldives and Togo. Eisai manufactured DEC tablets were provided in Sri Lanka only

January 2012

Continuously providing DEC*2 tablets to eliminate lymphatic filariasis (LF)

1 billion tablets have been shipped to 27 LF endemic countries

LF has been eliminated in 8 countries*3 so far

Initiatives to Improve Access to Medicines

Eisai’s continued commitment to eliminating NTDs*1

Eisai is the only Japanese company that joined the “London Declaration,” the largest

public-private partnership in the healthcare field, with the aim of eliminating 10 NTDs

Agreement to provide 2.2 billion high quality DEC tablets (medicine for LF) manufactured at

Eisai’s Vizag plant in India by 2020 at “Price Zero” (free of charge) to overcome supply

shortages worldwide

Eisai to provide high quality DEC tablets

continuously and in a stable manner

beyond 2020, until the goal to eliminate the

disease in endemic countries is achieved

Announced continued support

at the event marking “London

declaration’s fifth anniversary”

Long-term investment aiming at emerging middle-income class

as the results of elimination of NTDs and expansion of working population

April 2017

Integration of ESG*1

and Financial Integrity

*1: Environment, Social and Governance *2: CDP requests information on the risks and opportunities of climate from the world’s largest companies on behalf of 827 institutional investor

signatories with a combined US$100 trillion in assets (as of 2016). *3: Dow Jones Sustainability Asia Pacific Index. Selected 4 consecutive years *4: FTSE4Good Index Series. Selected 15

consecutive years. *5: Net DER: Net Debt Equity Ratio=(interest-bearing debts[Bonds and borrowings]-Cash and cash equivalents-Time deposits exceeding three months)/Equity attributable to

owners of the parent *6: Dividend per share subject to resolution of Board of Directors *7: Dividend on Equity 22

ESG Financial Integrity

Aim for sustainable enhancement of shareholder value

S

G

Joined the “London Declaration”, the largest public-private partnership in the healthcare field with the aim of

eliminating 10 NTDs, as the only Japanese company

Corporate Governance

Strong Balance Sheet

Ample Cash Flow

Net cash: 27.3B yen

Net DER*5: -0.05

Ratio of equity attributable to owners

of the parent: 57%

Secured 82.0B yen in free cash flow,

exceeding annual dividend payment*6

of 42.9B yen

Balancing strategic investment

and stable dividend

Strategic investmentExpansion of global brands

Acceleration of investment

in AD assets utilizing an

escrow account

M&A and partnership

Stable dividend policy

Dividend:

maintain 150 yen

DOE*7 8％ level

E

Recognized A- by CDP*2 Climate Change 2016Earned top-rating along with other companies

among healthcare sector in Japan

Listed for DJSI*3 and FTSE*4,

global socially responsible investment indexes

7 out of 11 board of directors are outside directors Clear separation of the function between the supervision of

management and the execution of businessThe Chair of the Board is an outside director and the CEO is the only director serving concurrently as a corporate officer

The Chairs of all committees (nomination, compensation, and audit) shall be appointed by the outside directors

Initiatives to improve Access to Medicine

Ranked 11th (among global companies) and 1st (among Japanese companies) in Access to Medicine Index

(ATM Index) 2016

FY2016 FY2017

Results % Forecast % YoY

Revenue 539.1 100.0 575.5 100.0 107

Cost of sales 195.9 36.3 206.0 35.8 105

Gross profit 343.2 63.7 369.5 64.2 108

R&D expenses 112.5 20.9 134.0 23.3 119

SG&A expenses 179.7 33.3 177.5 30.8 99

Other income & expenses 8.0 1.5 2.0 0.3 25

Operating profit 59.1 11.0 60.0 10.4 102

Profit for the year 42.2 7.8 41.3 7.2 98

Profit for the year(attributable to owners of the parent) 39.4 7.3 39.8 6.9 101

EPS (yen) 137.6 139.2 101

ROE (%) 6.8 6.8

DOE (%) 7.4 7.4

Dividends (yen) 150 150

Forecast for FY2017 (IFRS)

Sustain growth in main business while preparing for the future

FY2016 average exchange rates: USD 1: 108.38 yen, EUR 1: 118.78 yen, GBP 1: 141.59 yen, RMB 1: 16.10 yen

FY2017 average exchange rates (forecast): USD 1: 113 yen, EUR 1: 120 yen, GBP 1: 141 yen, RMB 1: 16.30 yen

The influence of risks relating to the patent infringement litigation for antiemetic agent Aloxi in the United States announced on May 3, 2017 has not been included.

23


Reference Data

24

FY2015 FY2016

Results % Results % YoY

Japan*1 284.9 52.0 291.1 54.0 102

Americas*2 122.2 22.3 117.2 21.7 96

China 49.3 9.0 49.3 9.1 100

Asia*3 34.0 6.2 34.7 6.4 102

EMEA*4 41.3 7.5 37.8 7.0 92

Pharmaceutical business

total531.8 97.1 530.1 98.3 100

Others 16.2 2.9 9.0 1.7 55

Consolidated revenue 547.9 100.0 539.1 100.0 98

Revenue by Reporting Segment

25


*1: Prescription medicines, generics and OTC products *2: North, Central and South America *3: Mainly South Korea, Taiwan, Hong Kong,

India and ASEAN *4: Europe, Middle East, Africa, Russia and Oceania

Breakdown of Revenue Migration

Growth of global brands*1

and Japan business

547.9

4,500

5,000

5,500

6,000

FY2015Revenue

Growth of globalbrands

Pharmaceuticalbusiness in Japan

Others FY2016Revenue

539.1

+6.6 -8.8B yen

YoY

-21.6+6.2

26

Major factors for increase Establishment of

EA Pharma Co., Ltd.

Expansion of branded drugs*3

Major factors for decrease Japan drug price revisions

Transfer of EIDIA Co., Ltd.

*2

(billions of yen)

Major factors for decrease Transfer of Eisai Food & Chemical Co., Ltd.

Impact of foreign exchange fluctuations

* Figures shown in breakdown are approximate.

*1: LENVIMA, Halaven, Fycompa, BELVIQ *2: Excludes revenue from Japan pharmaceutical business

*3: 13 branded drugs including the products designated by MHLW as Premium to promote the development of new drugs and eliminate off-label use: Halaven, Lenvima,

Fycompa, Humira, Lunesta, Maxalt, Fostoin, Careram, Inovelon, NerBloc, Gliadel, Treakisym and Lyrica (alliance revenue)

450

500

550

600

FY2015 FY2016

Results %% of

revenueResults %

% of

revenueYoY

Japan*1 114.3 66.3 40.1 103.3 59.1 35.5 90

Americas*2 23.6 13.7 19.3 34.4 19.7 29.4 146

China 12.6 7.3 25.5 13.7 7.8 27.8 109

Asia*3 8.3 4.8 24.4 9.3 5.3 26.9 113

EMEA*4 10.2 5.9 24.8 12.5 7.2 33.1 122

Pharmaceutical business

total168.9 98.1 31.8 173.3 99.1 32.7 103

Others 3.3 1.9 20.5 1.5 0.9 17.0 46

Reporting segment total 172.3 100.0 31.4 174.8 100.0 32.4 101

R&D expenses and group

headquarters’ management

costs, etc.(135.4) (125.1)

Gain from a bargain

purchase*5 9.3

Gain on sale of

subsidiaries*6 15.0 0.1

Consolidated operating profit 51.9 9.5 59.1 11.0 114

27

Profit by Reporting Segment


From the fiscal year ending March 31, 2017, the method for calculating the segment profit of pharmaceutical business and other business has changed. Following the change, other income

and expenses that had been allocated to pharmaceutical business and other business in the consolidated statement of income until the previous fiscal year is now reported under Group

headquarters’ management costs and other expenses. *1: Prescription medicines, generics and OTC products *2: North, Central and South America *3: Mainly South Korea, Taiwan, Hong

Kong, India and ASEAN *4: Europe, Middle East, Africa, Russia, and Oceania *5: Recognition of bargain purchase gain in April 2016, following acquisition of EA Pharma Co., Ltd. shares

*6: Transferred shares of EIDIA Co., Ltd. in December 2015, Eisai Food & Chemical Co., Ltd. in February 2016, and Sannova Co., Ltd. in April 2016

59.1

0

200

400

600

FY2015Operating profit

Growth of globalbrands

Pharmaceuticalbusiness in Japan

Reduction in R&Dexpenses

Others FY2016Operating profit

51.9

28

Breakdown of Operating Profit Migration

Growth of global brands*1 and cost efficiency

contributed to profit increase

*Figures shown in breakdown are approximate.

*1: LENVIMA, Halaven, Fycompa, and BELVIQ *2: Operating profit from LENVIMA, Halaven, Fycompa and BELVIQ, excluding Japan pharmaceutical business

*3: Segment profit *4: 13 branded drugs including the products designated by MHLW as Premium to promote the development of new drugs and eliminate off-label use:

Halaven, Lenvima, Fycompa, Humira, Lunesta, Maxalt, Fostoin, Careram, Inovelon, NerBloc, Gliadel, Treakisym and Lyrica (alliance revenue)

+7.1B yen

YoY+9.8+9.9

*2

-11.0

*3

-1.6

(billion of yen)

60

40

20

Major factors for increase Establishment of EA Pharma Co.,

Ltd.

Expansion of branded drugs*4

Major factors for decrease Japan drug price revisions

Transfer of EIDIA Co., Ltd.

Major factor for increase Gain from a bargain purchase

following acquisition of

EA Pharma Co., Ltd. shares +9.3

Major factor for decrease Transfer of shares of EIDIA Co., Ltd. -8.0

Transfer of shares of Eisai Food &

Chemical Co., Ltd. -7.0

Major factors for increase

Selection and focus in

priority pipeline

Cost efficiency through

co-development with partners

Impact of foreign exchange

fluctuations

FY2015 FY2016


Revenue 284.9 100.0 291.1 100.0 102

Prescription medicines 233.9 82.1 244.0 83.8 104

Humira 32.6 11.5 37.7 12.9 115

Aricept 40.5 14.2 29.5 10.1 73

Lyrica*1 24.7 8.7 24.3 8.3 98

Pariet*2, 3 30.4 10.7 21.2 7.3 70

Methycobal 20.8 7.3 18.2 6.2 87

Lunesta 6.0 2.1 8.0 2.8 134

Halaven 6.8 2.4 7.8 2.7 114

Warfarin 7.6 2.7 6.8 2.3 89

Livact*2 6.7 2.3

Elental*2 6.6 2.3

Actonel 6.4 2.3 5.6 1.9 88

Lenvima 1.5 0.5 2.7 0.9 175

Fycompa 0.5 0.2

Generics 28.5 10.0 28.0 9.6 98

Consumer Healthcare Business 18.1 6.3 19.0 6.5 105

Diagnostics 4.4 1.5

Segment profit 114.3 40.1 103.3 35.5 90

29

Performance of

Japan Pharmaceutical Business


*1: Alliance revenue *2: EA Pharma product

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

FY2015 FY2016


Revenue 122.2 100.0 117.2 100.0 96 ［106］

Aloxi 54.7 44.7 48.1 41.0 88 ［97］

Halaven 18.3 15.0 16.6 14.2 91 ［101］

Lenvima 8.8 7.2 15.1 12.9 172 ［190］

Banzel 13.2 10.8 13.8 11.8 105 ［116］

AcipHex 8.3 6.8 7.2 6.1 86 ［96］

Fycompa 3.8 3.1 5.3 4.5 137 ［152］

BELVIQ 4.4 3.6 3.7 3.2 84 ［93］

Segment profit 23.6 19.3 34.4 29.4 146 ［162］

30

Performance of

Americas Pharmaceutical Business


[ ] based on local currency

FY2015 FY2016


Revenue 34.0 100.0 34.7 100.0 102 ［113］

Aricept 10.0 29.3 9.8 28.1 98 ［108］

Humira 9.0 26.4 9.6 27.7 107 ［118］

Pariet 3.5 10.3 3.6 10.4 103 ［114］

Methycobal 3.1 9.1 2.9 8.2 93 ［104］

Halaven 1.9 5.6 2.0 5.8 104 ［116］

Fycompa 0.1 0.3 0.4 1.0 384 ［424］

Lenvima 0.0 0.0 0.3 0.9 3,217 ［3,557］

Segment profit 8.3 24.4 9.3 26.9 113 ［127］

FY2015 FY2016


Revenue 49.3 100.0 49.3 100.0 100 ［117］

Methycobal 18.7 38.0 18.0 36.5 96 ［112］Stronger Neo-Minophagen C and

Glycyron Tablets9.3 18.8 8.4 17.1 91 ［106］

Aricept 5.6 11.3 6.2 12.5 111 ［130］

Pariet 3.3 6.6 3.9 8.0 120 ［141］

Segment profit 12.6 25.5 13.7 27.8 109 ［141］

31

Performance of China and Asia*

Pharmaceutical Business

<China>

<Asia>


[ ] based on local currency


[ ] based on local currency* Mainly South Korea, Taiwan, Hong Kong, India, and ASEAN

FY2015 FY2016


Revenue 41.3 100.0 37.8 100.0 92 ［104］

Halaven 13.2 31.9 10.9 28.9 83 ［95］

Zonegran 7.6 18.5 5.2 13.7 68 ［78］

Fycompa 3.6 8.8 4.2 11.2 117 ［133］

Zebinix 3.8 9.3 3.6 9.5 94 ［106］

Lenvima / Kisplyx 1.1 2.7 3.3 8.8 297 ［336］

Inovelon 2.2 5.3 1.9 5.1 88 ［101］

Segment profit 10.2 24.8 12.5 33.1 122 ［131］

32

Performance of

EMEA* Pharmaceutical Business

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


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