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Page 1: To ShareholdersTTo Shareholderso Shareholders - · PDF fileInterim Report for the First Six Months of Fiscal Year 2016 To ShareholdersTTo Shareholderso Shareholders Eisai Supports

Interim Report for the First Six Months of Fiscal Year 2016

To ShareholdersTo ShareholdersTo Shareholders

Eisai Supports WHO’s LF elimination

To Our Shareholders

While an increase was recorded following growth of

Lenvima (anticancer agent) and Fycompa

(antiepileptic agent) as well as the contribution from

newly added consolidated subsidiary EA Pharma

Co., Ltd., Group revenue finished overall at ¥269,894

million (down 2.0% year on year) due in part to the

impact of national drug price revisions in Japan and

foreign currency fluctuations.

Operating profit totaled ¥38,590 million (up 113.5%

year on year) owing to one-off income following the

acquisition of EA Pharma shares (gain from a bargain

purchase) as well as growth in global brands,

improved performance and efficiency in operations,

while making proactive investment in priority research

and development projects. Profit for the period came

to ¥29,577 million (up 165.6% year on year).

The Company intends to set the interim dividend for

the period (at the end of the second quarter) at ¥70

per share (same amount as the previous year), and

expects to set the year-end dividend at ¥80 per

share (total dividend of ¥150 per share for the year).

We ask all of our shareholders for their continued

support going forward.

I thank you sincerely for your ongoing support. Here, we provide an overview of the Company’s operating performance during the first six months of fiscal year 2016.

Haruo Naito

Representative Corporate Officer

and CEO

Page 2: To ShareholdersTTo Shareholderso Shareholders - · PDF fileInterim Report for the First Six Months of Fiscal Year 2016 To ShareholdersTTo Shareholderso Shareholders Eisai Supports

To Shareholders

Stock Information Shareholder Return

Total number of authorized shares 1,100,000,000

Number of shares issued and outstanding 296,566,949

Number of shares held as treasury stock 10,505,045

Number of shareholders 59,368

(As of September 30, 2016)

Principal Shareholders(As of September 30, 2016)

Notes:1. Number of shares has been rounded down to the nearest

thousand.2. The percentage of shares held is calculated in proportion to

the number of issued shares and outstanding including treasury stock.

3. Treasury stock (10,505 thousand shares, 3.54%) has been excluded as it has no voting rights.

4. The chart includes only those major shareholders that were listed in the shareholder register as of September 30, 2016, and whose names could be confirmed.

(Thousands of shares) %

Japan Trustee ServicesBank, Ltd. (Trust Account)

31,937 10.77

The Master Trust Bank of Japan, Ltd. (Trust Account)

24,201 8.16

JP Morgan Chase Bank 385147

14,110 4.76

Nippon Life Insurance Company 12,281 4.14

Saitama Resona Bank, Limited 7,300 2.46

Trust & Custody Services Bank, Ltd. as trustee for Mizuho Bank, Ltd., Retirement Benefit Trust Account 5,437 1.83re-entrusted by Mizuho Trust and Banking Co., Ltd.

The Naito Foundation 4,207 1.42

Credit Suisse Securities (USA) LLC Spcl. For Excl. Ben 

4,162 1.40

The Bank of New York Mellon SA/NV 10

3,778 1.27

Trust & Custody Services Bank, Ltd. (Security 3,769 1.27Investment Trust Account)

The Company is devoted to providing sustainable and

stable dividends based on a healthy balance sheet

while giving consideration to various factors such as

consolidated financial performance, the dividend on

equity ratio (DOE)*1 and free cash flow. Acquisition of

treasury stock may be carried out appropriately after

factors such as the market environment and capital

efficiency are taken into account.

DOE is an index contributing to shareholder value

that encompasses both the dividend payout ratio,

which measures the extent to which profits are

distributed to shareholders in the form of dividends,

and return on equity (ROE)*2, which measures capital

efficiency. Also, DOE shows the ratio of dividend to

shareholders’ equity and thus serves as an index for

balance sheet management.

The Company intends to set the interim dividend

for the period (at the end of the second quarter) at

¥70 per share (same amount as the previous year),

and expects to set the year-end dividend at ¥80 per

share (total dividend of ¥150 per share for the year).

*1 DOE (Dividend on equity attributable to owners of the parent ratio) =

Total dividend payout / Equity attributable to owners of the parent

*2 ROE (Profit ratio to equity attributable to owners of the parent) =

Profit attributable to owners of the parent / Equity attributable to

owners of the parent

Year-end dividend Interim dividend DOE

FY2013FY2012 FY2014 FY2015 FY2016

Changes in Dividends and DOE

400

300

200

100

0

12

9

6

3

0

8.59.4

150

80

70

150

80

70

150

80

70

150

80

70

7.6 7.3

70

80

(Full-year forecast)

150

(%)(Yen per share)

Page 3: To ShareholdersTTo Shareholderso Shareholders - · PDF fileInterim Report for the First Six Months of Fiscal Year 2016 To ShareholdersTTo Shareholderso Shareholders Eisai Supports

To Shareholders

Consolidated Financial Results (IFRS)

55.0

44.0(Full-year forecast)

11.1

29.6

Revenue (Billions of yen) (Billions of yen)

800

600

400

200

0FY2015 FY2016 FY2015 FY2016

FY2015 FY2016 FY2015 FY2016

R&D Expenses

Full year Six months ended September 30

275.5

547.9548.0

(Full-year forecast)

116.2(Full-year forecast)

269.9

Operating Profit (Billions of yen)

75

50

25

0

160

120

80

40

0

122.3

62.855.0

Profit for the Period (Billions of yen)

60

40

20

0

18.1

51.9

60.0(Full-year forecast)

38.6

Percentage figures indicate the percentage of total sales.

Percentage figures indicate the percentage of total sales.

Percentage figures indicate the percentage of total sales.

Revenue by Therapeutic Area

Oncology area products¥57.9 billion, 21.5%Of which,

Halaven ¥18.6 billion

Lenvima ¥9.6 billion

Neurology area products¥80.0 billion, 29.6%Of which,

Aricept ¥25.1 billionThe others

Revenue by Reporting Segment

Americas pharmaceutical¥56.9 billion, 21.1%

Japan pharmaceutical¥149.7 billion, 55.5%

EMEA pharmaceutical¥18.2 billion, 6.7%

China pharmaceutical¥23.4 billion, 8.7%

Asia pharmaceutical¥17.1 billion, 6.3%

Other ¥4.7 billion, 1.7%

Japan pharmaceutical¥55.6 billion, 60.9%

Americas pharmaceutical¥16.2 billion, 17.7%

EMEA pharmaceutical¥6.6 billion, 7.3%

Asia pharmaceutical¥4.7 billion, 5.2%

China pharmaceutical¥7.3 billion, 8.0%

Other ¥0.9 billion, 1.0%

Profit by Reporting Segment

(Figures are rounded.)

This report includes forward-looking statements with respect to plans and forecasts of future results. Please understand that actual performance may differ significantly from these projections.

R&D expenses of ¥55.0 billion, Group headquarters’ management costs and other expenses of ¥7.1 billion and gain from a bargain purchase and others of ¥9.4 billion are not allocated to reporting segment profits.

Page 4: To ShareholdersTTo Shareholderso Shareholders - · PDF fileInterim Report for the First Six Months of Fiscal Year 2016 To ShareholdersTTo Shareholderso Shareholders Eisai Supports

To Shareholders

Ongoing Research & Development Projects

Development progress since April 2016 is as follows. (As of October 31, 2016)

In September 2016, the Company initiated a global Phase III clinical study of its

in-house developed anticancer agent, lenvatinib, in respective combination

regimens with the anticancer agent everolimus and the anti-PD-1 antibody

pembrolizumab as a potential first-line treatment for advanced renal cell

carcinoma. As this combination therapy is expected to enhance antitumor activity

than monotherapy, the Company aims to acquire approval as soon as possible.

The Company to Initiate Phase III Clinical Study of Lenvatinib (Japanese name: Lenvima) for Advanced Renal Cell Carcinoma

Therapeutic Areas

Product Name (Research Code)

DescriptionForm RegionDevelopment Status

Phase II Phase III Submission Approved

On

colo

gy

Neu

rolo

gy

Oth

er

China

OralE2006Anti-insomnia agent/Insomnia disorder*1 Japan/U.S./

Europe

U.S.

Anti-insomnia agent/Irregular sleep-wake rhythm disorder associated with Alzheimer’s disease*1

Japan/U.S.

OralLenvima(E7080)

Anticancer agent/Additional indication: Renal cell carcinoma/First-line U.S./Europe

OralFycompa(E2007) Antiepileptic agent/Additional indication: Lennox-Gastaut syndrome

Japan/U.S./Europe

Antiepileptic agent/Additional formulation: Oral suspensionU.S.

Europe

Antiepileptic agent/Additional indication: Pediatric epilepsyJapan/U.S./

Europe

Antiepileptic agent/Additional indication: Monotherapy for partial-onset seizures U.S.

Injection Anticancer agent/Breast cancer

Anticancer agent/HER2-negative breast cancer (in combination with PEGPH20*3)

OralBelviq

(APD356)

Humira(D2E7)

Antiobesity agent/Additional formulation: Obesity once-daily formulation

OralE2609 Anti-Alzheimer’s agent/Early Alzheimer’s disease*2

U.S.

InjectionFully human anti-TNF-α monoclonal antibody/Additional indication: Non-infectious uveitis

Japan

E6011 Injection Anti-Fractalkine antibody/Rheumatoid arthritis Japan

May

May

Apr.

Sep.

Jul.

Aug.

Sep.

I/II

Anticancer agent/Additional indication: Advanced soft tissue sarcoma (for liposarcoma)Halaven(E7389)

Europe

U.S.

Anticancer agent/Additional indication: Renal cell carcinoma/Second-line

U.S.

Europe

*1 Joint development with Purdue Pharma L.P. *2 Joint development with Biogen Inc. *3 Co-development with Halozyme Therapeutics, Inc. *4 Joint development with EA Pharma *5 Joint development by EA Pharma and Kissei Pharmaceutical *6 Development conducted by EA Pharma

Gastrointestinal Disorders

Pariet(E3810) Oral

Proton pump inhibitor/Additional dosage and administration: Maintenance therapy for proton pump inhibitor (PPI)-resistant reflux esophagitis10 mg twice daily*4

Japan

AJG511 Foam Ulcerative colitis treatment/Ulcerative colitis*5 Japan

E6007 Oral Ulcerative colitis treatment/Ulcerative colitis*6 Japan

Page 5: To ShareholdersTTo Shareholderso Shareholders - · PDF fileInterim Report for the First Six Months of Fiscal Year 2016 To ShareholdersTTo Shareholderso Shareholders Eisai Supports

To Shareholders

Topics

In April 2016, the Company launched the Dementia

Solutions Business*1. In addition to developing new

drugs aimed at dementia prevention, cure and care,

through this business the Company aims to contribute

to regional medicine, which provides peace of mind

and safety.

The Company will collaborate with leaders in

community health care from approximately 65 partners

in dementia-related coordination nationwide and provide

dementia solutions to local government and local

citizens. Our aim will be to contribute to the realization

of a society that coexists in harmony with dementia.

In July 2016, the Company launched an “interpro-

fessional collaboration service.” Patient care requires

close interaction among caregivers and their families,

Briefing for individual shareholders (Nagoya venue)

as well as physicians, nurses, pharmacists and others

in a variety of professions. To this end, the Company

provides a real-time information-sharing system using

mobile information terminals. The Company aims to

improve the level of care needed by obtaining advice in

this manner from people in a variety of professions.

The Company also provides adherence support

devices to keep people from forgetting to take their

medications, and a tracking tool using a tag-based IoT

device*2 to contribute to the realization of a society

where people with dementia can go out safely.

*1 Through business, the Company will analyze issues related to dementia and provide countermeasures.

*2 These compact radio transmitters provide location information over the Internet.

Contributing to Regional Medicine, Which Provides Peace of Mind and Safety, in the Field of Dementia

We plan to hold our next briefing for individual

investors in October 2017. We plan to

send out a notice around August 2017.

Holding Briefings for Individual Shareholders

In October 2016, the Company held briefings for

individual shareholders in Nagoya, Osaka, Fukuoka

and Hiroshima.

Each year, the Company holds its Ordinary General

Meeting of Shareholders in Tokyo. The Company

hold these briefings to facilitate communications with

individual shareholders outside Tokyo.

At each venue, Mr. Okada, the Company’s

executive vice president in charge of general affairs,

provided an overview of the Company’s business and

management strategies, followed by a question and

answer session. The questions were mainly the

Company’s financial outlook, share price and dividend

outlook, the impact of foreign exchange fluctuations

on operating performance and the development

status of pipelines such as next-generation drugs for

Alzheimer’s disease. The Company also fielded

questions regarding the application to drug discovery

of Nobel Prize-winning research (autophagy and

iPS cells).

The Company values its dialogue with shareholders,

and plans to continue providing such opportunities

for shareholder communication.

Using Smart Mobile Phones in an InterprofessionalCollaboration System for Real-Time Patient Information

Caremanager

Tag-based IoT* deviceto provide support

when going out

“Hikari One Team SP”e-Okusurisan

medication support device

Socialworker

Pharmacist

Careworker

PhysicianNurse

Caregivers, family

members

Keeping people from forgetting to take their medications

Realizing a society where people can go out with

peace of mind and in safety

Performing verification

tests in cooperation with

MAMORIO, Inc.

*loT: Internet of ThingsNTT IT has applied to register a trademark for “Hikari One Team SP”

Contributing to Regional Medicine, Which Provides Peace of Mind and Safety, in the Field of Dementia