To ShareholdersTTo Shareholderso Shareholders - · PDF fileInterim Report for the First Six...
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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
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)
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.
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
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