1. No category

Securities Code: 4523
FY 2014 (Ending March 31, 2015)
First Quarter Financial Results
Reference Data
August 1, 2014
Eisai Co., Ltd.
For Inquiries:
Public Relations: TEL +81-(0)3-3817-5120
Investor Relations: TEL +81-(0)3-3817-3016
http://www.eisai.com/
Forward-Looking Statements and Risk Factors
Materials and information provided in this financial disclosure may contain “forward-looking statements” based on current
expectations, forecasts, estimates, business goals and assumptions that are subject to risks and uncertainties, which 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 that may cause significant fluctuations in the consolidated results of the Eisai Group or have a material effect on
investment decisions are described below. These are risk factors that have been identified and assessed as of the
disclosure date of the Financial Report.
Risk factors associated with our business include, but are not limited to, challenges arising in overseas operations,
uncertainties in new drug development, as well as risks related to strategic alliances with partner companies, medical
cost-containment measures, generic drug products, intellectual property, possible occurrence of side effects, laws and
regulations, litigation, closure or shutdown of production plants, safety and quality of raw materials, outsourcing,
environmental issues, IT security and information management, financial market conditions and currency movement,
internal control systems, and disasters.
This English presentation was translated from the original Japanese version. In the event of any inconsistency between
the statements in the two versions, the statements in the Japanese version shall prevail.
Contents
1. Consolidated Statement of Income
--------------------
1
2. Capital Expenditures, Depreciation and Amortization
--------------------
2
3. Financial Results by Reporting Segment
--------------------
2
4. Business Segments
--------------------
3
5. Revenue from Major Products
--------------------
7
6. Sales Forecasts by Reporting Segment
--------------------
9
7. Consolidated Statement of Comprehensive Income
--------------------
10
8. Consolidated Statement of Cash Flows
--------------------
11
9. Consolidated Statement of Financial Position
--------------------
12
10. Changes in Quarterly Revenue for Major Products
--------------------
14
11. R&D Pipeline
--------------------
16
UK
(JPY/GBP)
151.59
150.30
159.44
171.31
171.91
172.63
170.00
China
(JPY/RMB)
16.05
16.05
16.41
16.59
16.40
16.32
17.00
Currency Exchange Rates
FY 2013 Q1
FY 2013
FY 2014 Q1
FY 2014
Quarterly Average Rate
Quarter End Rate
Yearly Average
Year End Rate
Quarterly Average Rate
Quarter End Rate
Yearly Forecast Rate
US
(JPY/USD)
98.75
98.59
100.23
102.92
102.16
101.36
103.00
EU
(JPY/EUR)
128.94
128.53
134.36
141.65
140.06
138.31
140.00
* The Eisai Group decided to voluntarily adopt the International Financial Reporting Standards following the FY 2013
consolidated financial statements, and in line with this change, the consolidated financial statements for Q1 of FY2014
are disclosed according to IFRS.
* The Eisai Group classifies its reporting segments into two business categories, namely, pharmaceutical business and
other business. The Group has defined the following segments as reporting segments for its pharmaceutical
business: Japan (Prescription medicines, Generics and Diagnostics), Americas (North, Central and South America),
Asia (mainly China, South Korea, Taiwan, India and ASEAN), EMEA (Europe, the Middle East, Africa and Oceania),
and Consumer Healthcare Business―Japan (mainly OTC products).
* All amounts are rounded to the nearest specified unit.
1. Consolidated Statement of Income
(billions of yen)
FY 2013
Q1
Revenue
FY 2014
Ratio
Full
Ratio
(%)
year
(%)
Q1
FY 2014
Ratio
YOY
(%)
(%)
Diff.
Full
Ratio
year (est.)
(%)
152.8
100.0
599.5
100.0
132.8
100.0
86.9
(20.0)
566.0
100.0
46.2
30.2
194.7
32.5
48.1
36.2
104.1
1.9
200.0
35.3
106.6
69.8
404.8
67.5
84.7
63.8
79.4
(21.9)
366.0
64.7
50.6
33.1
203.3
33.9
47.2
35.5
93.2
(3.4)
191.5
33.8
Selling expenses
21.8
14.3
78.9
13.2
16.8
12.7
77.3
(5.0)
－
－
Personnel expenses
18.4
12.0
74.2
12.4
19.3
14.5
105.0
0.9
－
－
Administrative and other expenses
10.4
6.8
50.2
8.4
11.0
8.3
105.5
0.6
－
－
37.3
24.4
136.3
22.7
29.1
21.9
78.1
(8.2)
121.5
21.5
Other income
0.3
0.2
4.1
0.7
0.2
0.1
58.1
(0.1)
－
－
Other expenses
0.4
0.3
2.8
0.5
0.1
0.1
28.1
(0.3)
－
－
Operating profit
18.6
12.1
66.4
11.1
8.5
6.4
45.6
(10.1)
53.0
9.4
Financial income
0.7
0.5
1.8
0.3
0.6
0.4
82.3
(0.1)
－
－
Financial costs
1.6
1.1
5.9
1.0
1.3
1.0
81.4
(0.3)
－
－
17.7
11.6
62.3
10.4
7.7
5.8
43.8
(9.9)
－
－
5.3
3.5
23.8
4.0
2.0
1.5
37.6
(3.3)
－
－
12.3
8.1
38.5
6.4
5.7
4.3
46.4
(6.6)
35.0
6.2
12.3
8.0
38.3
6.4
5.7
4.3
46.3
(6.6)
－
－
0.1
0.1
0.3
0.00
0.1
0.0
57.9
(0.0)
－
－
29.8
19.50
8.45
14.1
0.7
0.5
2.3
(29.1)
Cost of sales
Gross profit
Selling, general and administrative expenses
Research and development expenses
Profit before income taxes
Income taxes
Profit for the period
Attributable to
Owners of the parent
Non-controlling interests
Comprehensive income for the period
Earnings per share (EPS, yen)
43.0
134.1
19.9
122.4
Dividends per share (DPS, yen)
－
150.0
－
150.0
Return on equity (ROE, %)
－
7.6
－
6.7
Dividend on equity ratio (DOE, %)
－
8.5
－
8.2
41.8
40.8
39.1
Overseas revenue ratio(%)
*Full year estimation for selling, general and administrative expenses includes other income and other expenses
Notes
Revenue
Growth in global brands (Halaven, Fycompa, BELVIQ)
Decrease in the revenue of Pariet/Aciphex and Aricept due to Japanese drug price revisions and LOE in the
U.S.
Cost of sales ratio
Increase due to change in the product mix
Selling, general and administrative expenses
Decrease in alliance fees paid to co-promotion partners
Proactive investment in global brands, Asia, and expansion countries
Research and development expenses
Exchange rate effects
Exchange rate sensitivity
Milestone payments to development partners booked in the previous year (first quarter in FY 2013)
Upfront payment received upon the execution of options related to joint development
Proactive investment in engaging R&D in order to accelerate key pipeline projects
Revenue: 2.1 billion yen, operating profit: -600 million yen
Revenue (U.S. dollars: 1.04 billion yen, Euro: 200 million yen, U.K. pounds: 30 million yen),
Operating profit (U.S. dollars: -580 million yen, Euro: 120 million yen, U.K. pounds: -110 million yen)
(effect of a 1 yen increase in currency value)
Reference Data [Consolidated] 1
August 1, 2014 / Eisai Co., Ltd.
2. Capital Expenditures, Depreciation and Amortization
(billions of yen)
FY 2013
Q1
Capital expenditure
FY 2014
Full year
Q1
Diff.
Full year (est.)
10.6
31.2
3.8
(6.8)
27.5
Property, plant and equipment
1.5
12.3
1.9
0.4
12.0
Intangible assets
9.1
18.9
1.9
(7.2)
15.5
10.3
39.9
9.3
(1.0)
37.6
Depreciation and amortization
3. Financial Results by Reporting Segment
1) Revenue by Reporting Segment
(billions of yen)
FY 2013
FY 2014
(Excl. exchange
rate effects)
Q1
Full year
Q1
YOY (%)
YOY (%)
Japan Pharmaceutical Business
81.1
311.0
73.7
90.9
90.9
Americas Pharmaceutical Business
41.3
158.9
25.4
61.5
59.5
United States
41.1
158.3
25.2
61.3
59.2
Asia Pharmaceutical Business
13.4
58.0
16.3
121.8
118.5
China
7.0
31.8
9.2
130.2
127.5
EMEA Pharmaceutical Business
7.7
32.0
8.8
115.3
105.9
Consumer Healthcare Business - Japan (mainly OTC products)
4.2
19.3
3.8
90.1
90.1
Other
5.3
20.2
4.8
91.7
90.4
152.8
599.5
132.8
86.9
85.6
Consolidated Revenue
*Includes revenue from external customers
2) Profit by Reporting Segment
(billions of yen)
FY2013
FY 2014
(Excl. exchange
rate effects)
Q1
Japan Pharmaceutical Business
Full year
Q1
YOY (%)
YOY (%)
42.9
－
33.7
78.5
78.5
Americas Pharmaceutical Business
8.7
－
0.1
1.0
1.0
Asia Pharmaceutical Business
3.0
－
4.3
141.8
138.4
EMEA Pharmaceutical Business
0.7
－
1.1
144.4
124.6
Consumer Healthcare Business - Japan (mainly OTC products)
0.5
－
(0.2)
－
－
Other
2.6
－
1.3
50.0
48.0
37.3
－
29.1
78.1
75.8
2.7
－
2.7
101.8
101.8
18.6
－
8.5
45.6
48.6
R&D Expenses
Group headquarters' management costs and other expenses
Consolidated Operating Profit
Reference Data [Consolidated] 2
August 1, 2014 / Eisai Co., Ltd.
4. Business Segments
1) Japan Pharmaceutical Business
(billions of yen)
FY 2013
Q1
Revenue
FY 2014
Full year
Q1
YOY (%)
81.1
31.10
73.7
90.9
73.9
281.6
66.0
89.3
Generics (Elmed Eisai Co., Ltd.)
5.8
23.4
6.4
109.9
Diagnostics (EIDIA Co., Ltd.)
1.4
6.0
1.4
98.2
4.29
－
33.7
78.5
18.3
65.0
13.4
73.3
12.8
47.3
10.8
84.2
6.9
28.8
7.8
112.1
6.7
25.2
6.3
94.3
4.1
19.4
4.3
103.7
2.6
9.7
2.4
94.8
2.2
7.7
1.9
85.9
1.6
6.4
1.6
95.7
1.8
6.7
1.4
76.2
0.6
2.9
1.0
176.3
Prescription medicines
Segment profit
Japan prescription pharmaceuticals - revenue from major products
Anti-Alzheimer's agent
Aricept
Proton pump inhibitor
Pariet
Fully human anti-TNF-α monoclonal antibody
Humira
Peripheral neuropathy treatment
Methycobal
Pain treatment (neuropathic pain, fibromyalgia)
Lyrica*
Oral anticoagulant
Warfarin
Osteoporosis treatment
Actonel
Anticancer agent
Halaven
Gastritis / gastric ulcer treatment
Selbex
Insomnia treatment
Lunesta
* The revenue from Pariet includes the sale of triple formulation packs for Helicobacter pylori eradication, Rabecure Pack 400/800 and Rabefine Pack.
* Co-promotion income has been booked as the revenue for Lyrica.
Reference Data [Consolidated] 3
August 1, 2014 / Eisai Co., Ltd.
2) Americas Pharmaceutical Business (North, Central and South America)
FY 2013
Q1
Revenue
FY 2014
Full year
Q1
YOY (%)
Billions JPY
41.3
158.9
25.4
61.5
<59.5>
United States
Billions JPY
41.1
158.3
25.2
61.3
<59.2>
Segment profit
Billions JPY
8.7
－
0.1
1.0
<1.0>
Americas - revenue from major products
Antiemetic agent
Billions JPY
10.3
42.9
12.6
121.6
<117.5>
Billions JPY
[Millions USD]
10.3
[105]
42.9
[428]
12.6
[123]
121.6
<117.5>
Billions JPY
[Millions USD]
15.5
[157]
37.7
[376]
3.9
[38]
24.9
<24.1>
Billions JPY
3.3
13.4
3.8
116.9
<113.1>
Billions JPY
[Millions USD]
3.2
[32]
13.1
[130]
3.7
[36]
115.7
<111.8>
Billions JPY
1.5
7.6
2.2
145.5
<140.8>
Billions JPY
[Millions USD]
1.5
[15]
7.5
[75]
2.2
[22]
146.4
<141.5>
Billions JPY
[Millions USD]
0.4
[4]
2.5
[25]
1.0
[10]
249.5
<241.2>
Billions JPY
0
0.8
0.2
1,547.5
<1511.2>
Billions JPY
[Millions USD]
－
[－]
0.7
[7]
0.1
[1]
Aloxi
United States
Proton pump inhibitor
Aciphex
Anticancer agent
Halaven
United States
Antiepileptic agent
Banzel
United States
Antiobesity agent
BELVIQ
Antiepileptic agent
Fycompa
United States
－
<－>
* The U.S. is the only country in the Americas where Eisai exclusively markets Aciphex and BELVIQ.
* Year-on-year percentage: figures shown in angle brackets “< >” exclude the effects of foreign currency fluctuations.
Reference Data [Consolidated] 4
August 1, 2014 / Eisai Co., Ltd.
3) Asia Pharmaceutical Business (mainly China, South Korea, Taiwan, India and ASEAN)
FY 2013
Q1
FY 2014
Full year
Q1
YOY (%)
Revenue
Billions JPY
13.4
58.0
16.3
121.8
<118.5>
China
Billions JPY
7.0
31.8
9.2
130.2
<127.5>
Segment profit
Billions JPY
3.0
－
4.3
141.8
<124.6>
Asia - revenue from major products
Peripheral neuropathy treatment
Billions JPY
3.6
16.1
4.6
129.1
<127.4>
Billions JPY
[Millions RMB]
3.0
[188]
13.8
[844]
4.0
[245]
133.7
<130.9>
Billions JPY
2.9
12.0
3.2
109.6
<104.0>
Billions JPY
[Millions RMB]
1.0
[62]
3.8
[234]
1.1
<67>
110.4
<108.1>
Billions JPY
1.6
6.8
2.0
Methycobal
China
Anti-Alzheimer's agent
Aricept
China
Fully human anti-TNF-α monoclonal antibody
Humira
Proton pump inhibitor
Billions JPY
1.4
5.7
1.5
108.2
<107.2>
Billions JPY
[Millions RMB]
0.5
[34]
2.2
[135]
0.7
(43)
130.0
<127.2>
Billions JPY
1.2
5.5
1.3
110.6
<108.2>
Billions JPY
[Millions RMB]
1.2
[74]
5.4
[331]
1.3
[80]
110.9
<108.5>
Billions JPY
0.1
0.5
0.2
347.5
<343.8>
Pariet
China
Liver disease / Allergic disease agents
Stronger Neo-Minophagen C and Glycyron Tablets
China
Anticancer agent
122.3
<113.5>
Halaven
* Year-on-year percentage: figures shown in angle brackets “< >” exclude the effects of foreign currency fluctuations.
Reference Data [Consolidated] 5
August 1, 2014 / Eisai Co., Ltd.
4) EMEA Pharmaceutical Business (Europe, the Middle East, Africa and Oceania)
FY 2013
Q1
FY 2014
Full year
Q1
YOY (%)
Revenue
Billions JPY
7.7
32.0
8.8
Segment profit
Billions JPY
0.7
－
1.1
115.3
<105.9>
144.4
<124.6>
EMEA - revenue from major products
Anticancer agent
Billions JPY
2.0
8.5
2.6
129.5
<118.8>
Billions JPY
1.5
6.6
1.9
126.9
<116.2>
Billions JPY
0.5
2.4
0.7
127.5
<117.0>
Billions JPY
0.6
1.3
0.5
Halaven
Antiepileptic agent
Zonegran
Antiepileptic agent
Zebinix
Antiepileptic drug
95.6
<86.8>
Fycompa
Antiepileptic agent
Billions JPY
0.5
1.9
0.5
116.9
<107.2>
Inovelon
* Year-on-year percentage: figures shown in angle brackets “< >” exclude the effects of foreign currency fluctuations.
5) Consumer Healthcare Business―Japan (mainly OTC products)
(billions of yen)
FY 2013
Q1
FY 2014
Year end
Revenue
4.2
19.3
Segment profit (loss)
0.5
－
Q1
YOY (%)
3.8
(0.2)
90.1
－
Consumer Healthcare Business―Japan - revenue from major products
Vitamin B2 preparation, "Chocola BB Plus," etc.
2.9
Chocola BB Group
Reference Data [Consolidated] 6
12.0
2.5
87.5
August 1, 2014 / Eisai Co., Ltd.
5. Revenue from Major Products
1) Oncology-Related Products
FY 2013
Q1
Total
Billions JPY
FY 2014
Full year
27.1
Q1
100.7
YOY (%)
24.2
89.4
<86.2>
Halaven (Anticancer agent)
Billions JPY
6.9
28.8
8.2
117.6
<112.8>
Japan
Americas
Billions JPY
1.6
6.4
1.6
Billions JPY
3.3
13.4
3.8
116.9
<113.1>
Asia
Billions JPY
0.1
0.5
0.2
347.5
<343.8>
EMEA
Billions JPY
2.0
8.5
2.6
129.5
<118.8>
Aloxi (Antiemetic agent)
Billions JPY
10.3
42.9
12.6
121.6
<117.5>
Treakisym/Symbenda (Anticancer agent)
Billions JPY
1.0
3.9
1.0
100.1
<99.6>
Other
Billions JPY
8.8
25.1
2.5
28.2
<27.2>
95.7
* Year-on-year percentage: figures shown in angle brackets “< >” exclude the effects of foreign currency fluctuations.
2) Epilepsy-Related Products
FY 2013
Q1
Total
Billions JPY
FY 2014
Full year
5.5
Q1
24.1
YOY (%)
7.1
129.5
<121.9>
Fycompa
Billions JPY
0.6
2.1
0.7
120.8
<111.5>
Americas
Billions JPY
0
0.8
0.2
1,547.5
<1511.2>
EMEA
Billions JPY
0.6
1.3
0.5
95.6
<86.8>
Zonegran
Billions JPY
2.1
9.1
2.6
121.5
<112.8>
EMEA
Billions JPY
1.5
6.6
1.9
126.9
<116.2>
Billions JPY
2.0
9.7
2.9
141.8
<135.9>
Billions JPY
1.5
7.6
2.2
145.5
<140.8>
EMEA
Billions JPY
[Millions USD]
0.5
1.9
0.5
116.9
<107.2>
Zebinix
Billions JPY
0.5
2.4
0.7
127.5
<117.0>
Other
Billions JPY
0.2
0.9
0.3
121.7
<121.7>
Inovelon/ Banzel
Americas
* Year-on-year percentage: figures shown in angle brackets “< >” exclude the effects of foreign currency fluctuations.
Reference Data [Consolidated] 7
August 1, 2014 / Eisai Co., Ltd.
3) Pariet/Aciphex (Proton pump inhibitor)
FY 2013
Q1
Total
Billions JPY
FY 2014
Full year
29.9
Q1
91.4
YOY (%)
16.3
54.6
<54.1>
Japan
Billions JPY
12.8
47.3
10.8
84.2
Americas
Billions JPY
15.5
37.7
3.9
24.9
<24.1>
Asia
Billions JPY
1.4
5.7
1.5
108.2
<107.2>
* The revenue from Pariet in Japan includes the sale of triple formulation packs for Helicobacter pylori eradication, Rabecure Pack 400/800 and Rabefine Pack.
* Year-on-year percentage: figures shown in angle brackets “< >” exclude the effects of foreign currency fluctuations.
4) Aricept (Anti-Alzheimer's agent)
FY 2013
Q1
Total
Billions JPY
FY 2014
Full year
23.2
82.7
Q1
YOY (%)
16.4
70.5
<69.8>
Japan
Asia
Billions JPY
18.3
65.1
13.4
2.9
12.0
3.2
73.3
109.6
<104.0>
* Year-on-year percentage: figures shown in angle brackets “< >” exclude the effects of foreign currency fluctuations.
Reference Data [Consolidated] 8
August 1, 2014 / Eisai Co., Ltd.
6. Sales Forecasts by Reporting Segment (FY 2014)
(billions of yen)
FY 2013
Q1
Japan
FY 2014
Full year
Q1
Full year (est.)
81.1
311.0
73.7
307.5
73.9
281.6
66.0
274.0
18.3
65.0
13.4
59.5
12.8
47.3
10.8
42.0
6.9
28.8
7.8
30.5
6.7
25.2
6.3
23.0
2.6
9.7
2.4
9.0
1.6
6.4
1.6
9.0
2.2
7.7
1.9
7.0
0.6
2.9
1.0
6.5
1.8
6.7
1.4
6.0
Generics (Elmed Eisai Co., Ltd.)
5.8
23.4
6.4
27.5
Diagnostics (EIDIA Co., Ltd.)
1.4
6.0
1.4
6.0
Americas
41.3
158.9
25.4
111.5
United States
41.1
158.3
25.2
110.0
Asia
13.4
58.0
16.3
67.5
China
7.0
31.8
9.2
38.0
EMEA
7.7
32.0
8.8
40.0
4.2
19.3
3.8
21.0
2.9
12.0
2.5
12.5
5.3
20.2
4.8
18.5
152.8
599.5
132.8
566.0
Pariet/Aciphex
29.9
91.4
16.3
53.0
Aricept
23.2
82.7
16.4
75.5
Halaven
6.9
28.8
8.2
39.0
Japan
1.6
6.4
1.6
9.0
Americas
3.3
13.4
3.8
15.5
Asia
0.1
0.5
0.2
1.0
EMEA
2.0
8.5
2.6
13.5
0.6
2.1
0.7
9.5
0
0.8
0.2
7.0
0.6
1.3
0.5
2.5
Prescription medicines
Anti-Alzheimer's agent
Aricept
Proton pump inhibitor
Pariet
Fully human anti-TNF-α monoclonal antibody
Humira
Peripheral neuropathy treatment
Methycobal
Oral anticoagulant
Warfarin
Anticancer agent
Halaven
Osteoporosis treatment
Actonel
Insomnia treatment
Lunesta
Gastritis / gastric ulcer treatment
Selbex
Consumer Healthcare Business - Japan (mainly OTC products)
Vitamin B2 preparation, "Chocola BB Plus," etc.
Chocola BB Group
Other
Consolidated revenue
Global revenue from major products
Fycompa
Americas
EMEA
Reference Data [Consolidated] 9
August 1, 2014 / Eisai Co., Ltd.
7. Consolidated Statement of Comprehensive Income
(billions of yen)
FY 2013
Q1
Profit for the period
FY 2014
Full year
Q1
YOY (%)
Diff.
12.3
38.5
5.7
46.4
(6.6)
0
3.8
0.1
139.1
0
－
2.5
－
－
－
0
6.4
0.1
139.1
0
17.0
38.8
(5.3)
0.4
0.8
0.2
17.4
39.6
Total other comprehensive income (loss), net of tax
17.4
Comprehensive income (loss) for the period
Other comprehensive income
Items that will not be reclassified to profit or loss
Financial assets measured at fair value through other comprehensive income
Remeasurements of defined benefit plans
Subtotal
Items that may be reclassified subsequently to profit or loss
Exchange differences on translation of foreign operations
Cash flow hedges
Subtotal
－
(22.4)
63.1
(0.1)
(5.1)
－
(22.5)
46.0
(5.0)
－
(22.5)
29.8
84.5
0.7
2.3
(29.1)
29.7
84.3
0.6
2.2
(29.1)
0.1
0.2
0.1
89.9
(0)
Attributable to
Owners of the parent
Non-controlling interests
Reference Data [Consolidated] 10
August 1, 2014 / Eisai Co., Ltd.
8. Consolidated Statement of Cash Flows
(billions of yen)
FY 2013
FY 2014
Q1
Q1
Diff.
Operating activities
Profit before income taxes
17.7
7.7
(9.9)
Depreciation and amortization
10.3
9.3
(1.0)
(Increase) decrease in working capital
(3.1)
(4.7)
(1.6)
0.9
0.6
(0.3)
Interest paid
(1.5)
(0.7)
0.8
Income taxes paid
(6.7)
(3.4)
3.3
Other
(3.0)
(0.9)
2.1
Net cash from operating activities
14.6
7.9
(6.6)
(3.0)
(2.0)
1.0
Interest and dividends received
Investing activities
Purchases of property, plant and equipment (1)
Proceeds from sale of property, plant and equipment (2)
0.3
Purchases of intangible assets (3)
0
(0.3)
(9.1)
(1.2)
7.9
(11.8)
(3.2)
8.6
(0.7)
(1.9)
(1.2)
2.8
1.7
(1.1)
Payments of time deposits exceeding 3 months
(1.8)
(1.9)
(0.1)
Proceeds from redemption of time deposits exceeding 3 months
38.2
1.0
(37.2)
0
0.1
0.1
26.8
(4.1)
(30.9)
10.5
4.5
(6.0)
Repayment of long-term borrowings
(19.8)
(10.2)
9.5
Redemption of bonds
(50.0)
－
50.0
Dividends paid
(22.8)
(22.8)
(0)
(0.2)
(0.2)
(0)
(82.2)
(28.7)
53.5
6.7
(1.9)
(8.6)
<Capital expenditure (cash basis)> (1)+(2)+(3)
Purchases of financial assets
Proceeds from sale and redemption of financial assets
Other
Net cash from (used in) investing activities
Financing activities
Net increase (decrease) in short-term borrowings
Other
Net cash from (used in) financing activities
Effect of exchange rate change on cash and cash equivalents
Net increase (decrease) in cash and cash equivalents
(34.2)
(26.8)
7.4
Cash and cash equivalents at beginning of period
142.5
153.9
11.5
Cash and cash equivalents at end of period
108.3
127.1
18.9
2.8
4.7
2.0
Free cash flow
* "Free cash flow" = "Net cash provided by (used in) operating activities" - "Capital expenditures, etc. (cash basis)"
Notes
Cash flow from operating activities:
Decrease in profit before taxes, etc.
Cash flow from investing activities:
Proceeds from redemption of time deposits exceeding 3 months used for redemption of corporate bonds in the corresponding period of the previous
fiscal year
Cash flow from financing activities
Repayments of long-term borrowings in the U.S
Redemption of corporate bonds occured in the corresponding period of the previous fiscal year
Reference Data [Consolidated] 11
August 1, 2014 / Eisai Co., Ltd.
9. Consolidated Statement of Financial Position
<Assets>
(billions of yen)
FY 2013
March 31
FY 2014
Ratio (%)
June 30
Ratio (%)
% change
Diff.
Assets
Non-current assets
Property, plant and equipment
134.1
13.8
131.8
14.0
98.3
(2.3)
Goodwill
157.4
16.2
155.0
16.5
98.5
(2.4)
Intangible assets
108.4
11.1
103.6
11.0
95.6
(4.8)
40.8
4.2
40.7
4.3
99.8
(0.1)
4.2
0.4
3.0
0.3
71.4
(1.2)
Deferred tax assets
69.2
7.1
70.1
7.5
101.3
0.9
Total non-current assets
514.0
52.8
504.2
53.7
98.1
(9.9)
87.7
9.0
85.8
9.1
97.8
(1.9)
186.5
19.2
187.4
20.0
100.4
0.8
Other financial assets
20.2
2.1
21.9
2.3
108.6
1.7
Other assets
11.4
1.2
12.1
1.3
106.3
0.7
153.9
15.8
127.1
13.5
82.6
(26.8)
Total current assets
459.8
47.2
434.4
46.3
94.5
(25.4)
Total assets
973.8
100.0
938.6
100.0
96.4
(35.2)
Other financial assets
Other assets
Current assets
Inventories
Trade and other receivables
Cash and cash equivalents
Notes
Total assets
Decrease in cash and cash equivalents due to payments of long-term borrowings and year-end dividends
Reference Data [Consolidated] 12
August 1, 2014 / Eisai Co., Ltd.
<Equity and Liabilities >
(billions of yen)
FY 2013
March 31
FY 2014
Ratio (%)
June 30
Ratio (%)
% change
Diff.
Equity
Equity attributable to owners of the Company
Share capital
45.0
4.6
45.0
4.8
100.0
－
Capital surplus
57.9
6.0
57.9
6.2
100.0
(0)
Treasury shares
(38.5)
(4.0)
(38.3)
(4.1)
99.7
0.1
Retained earnings
379.2
38.9
362.1
38.6
95.5
(17.1)
82.7
8.5
77.6
8.3
93.8
(5.1)
526.3
54.0
504.3
53.7
95.8
(22.0)
3.1
0.3
3.1
0.3
101.2
(0)
529.4
54.4
507.4
54.1
95.8
(22.0)
195.7
20.1
155.2
16.5
79.3
(40.6)
2.6
0.3
3.1
0.3
117.9
0.5
15.5
1.6
15.3
1.6
99.0
(0.2)
1.1
0.1
1.2
0.1
104.5
0.1
27.7
2.8
25.6
2.7
92.2
(2.2)
0.3
0.0
0.3
0.0
97.9
(0.0)
243.1
25.0
200.7
21.4
82.6
(42.4)
Bonds and borrowings
51.5
5.3
85.8
9.1
166.7
34.3
Trade and other payables
62.2
6.4
56.8
6.1
91.3
(5.4)
Other financial liabilities
5.1
0.5
4.6
0.5
89.5
(0.5)
Income tax payables
3.9
0.4
3.2
0.3
82.8
(0.7)
Provisions
13.0
1.3
11.7
1.2
89.6
(1.4)
Other liabilities
65.5
6.7
68.4
7.3
104.3
2.8
Total current liabilities
201.3
20.7
230.5
24.6
114.5
29.2
Total liabilities
444.4
45.6
431.2
45.9
97.0
(13.2)
Total equity and liabilities
973.8
100.0
938.6
100.0
96.4
(35.2)
Other components of equity
Total equity attributable to owners of the parent
Non-controlling interests
Total equity
Liabilities
Non-current liabilities
Bonds and borrowings
Other financial liabilities
Retirement benefit liabilities
Provisions
Other liabilities
Deferred tax liabilities
Total non-current liabilities
Current liabilities
Notes
Total equity
Decrease in retained earnings due to payments of year-end dividends
Total liabilities
Decrease in borrowings due to repayments of long-term borrowings
Reference Data [Consolidated] 13
August 1, 2014 / Eisai Co., Ltd.
10. Changes in Quarterly Revenue for Major Products
1) Oncology-Related Products
FY 2013
Q1
Q2
FY 2014
Q3
Q4
Q1
Total
Billions JPY
27.1
26.6
23.6
23.4
24.2
Halaven (Anticancer agent)
Japan
Billions JPY
6.9
6.9
7.5
7.5
8.2
Billions JPY
1.6
1.6
1.7
1.5
1.6
Billions JPY
3.3
3.2
3.4
3.4
3.8
Americas
Asia
EMEA
Aloxi (Antiemetic agent)
Treakisym/Symbenda (Anticancer agent)
Other
Billions JPY
0.1
0.1
0.2
0.2
0.2
Billions JPY
2.0
1.9
2.2
2.4
2.6
Billions JPY
10.3
11.1
10.8
10.7
12.6
Billions JPY
1.0
1.0
1.0
0.9
1.0
Billions JPY
8.8
7.6
4.3
4.3
2.5
2) Epilepsy-Related Products
FY 2013
Q1
Q2
FY 2014
Q3
4Q
Q1
Total
Billions JPY
5.5
5.2
6.6
6.8
7.1
Fycompa
Billions JPY
0.6
0.1
0.3
1.1
0.7
Americas
EMEA
Zonegran
Billions JPY
0.0
0.0
0.0
0.7
0.2
Billions JPY
0.6
0.1
0.3
0.3
0.5
Billions JPY
2.1
2.2
2.5
2.3
2.6
EMEA
Inovelon/Banzel
Billions JPY
1.5
1.6
1.7
1.7
1.9
Billions JPY
2.0
2.1
3.0
2.6
2.9
Americas
EMEA
Zebinix
Other
Billions JPY
1.5
1.7
2.4
2.0
2.2
Billions JPY
0.5
0.4
0.5
0.5
0.5
Billions JPY
0.5
0.6
0.6
0.7
0.7
Billions JPY
0.2
0.2
0.3
0.2
0.3
Reference Data [Consolidated] 14
August 1, 2014 / Eisai Co., Ltd.
3) Pariet/Aciphex (Proton-pump inhibitor)
FY 2013
Q1
Q2
FY 2014
Q3
Q4
Q1
Total
Billions JPY
29.9
28.9
16.2
16.5
16.3
Japan
Billions JPY
12.8
12.4
11.8
10.4
10.8
Americas
Billions JPY
15.5
15.1
2.8
4.3
3.9
Asia
Billions JPY
1.4
1.3
1.4
1.5
1.5
EMEA
Billions JPY
0.2
0.1
0.2
0.2
0.1
* The revenue from Pariet in Japan includes the sale of triple formulation packs for Helicobacter pylori eradication, Rabecure Pack 400/800 and Rabefine Pack.
4) Aricept (Anti-Alzheimer's agent)
FY 2013
Q1
Q2
FY 2014
Q3
Q4
Q1
Total
Billions JPY
23.2
22.1
21.0
16.4
16.4
Japan
Billions JPY
18.3
17.3
16.7
12.8
13.4
Asia
Billions JPY
2.9
3.0
2.9
3.1
3.2
Reference Data [Consolidated] 15
August 1, 2014 / Eisai Co., Ltd.
11. Major R&D Pipeline
In-House R&D Pipeline List
Product Name / Development Code
Additional
Indication, etc.*
Development Stage**
Therapeutic Area
AI
(EU) approved
Oncology and Supportive Care
(CN) submitted
(JP) submitted
Gastrointestinal and Hepatic Disorders
AI
AI, AF
(JP) submitted
Gastrointestinal and Hepatic Disorders
AF
(JP) submitted
(JP) submitted
(US/EU/AS) preparing
for submission
Vascular and Immunological Reaction
(JP/CN/AS) PIII
(US/EU/AS) PIII
Neurology
(JP/US/EU/AS) PIII
Vascular and Immunological Reaction
Oncology and Supportive Care
AI
AI
AI
(CN) PIII
(JP/US/EU/CN/AS) PIII
(JP/US/EU/AS) PIII
(JP/US/EU/AS) PIII
(JP/US/EU/AS) PIII
(US/EU/AS) PIII
AI
(US) PIII
Oncology and Supportive Care
AI
(JP) PIII
Oncology and Supportive Care
AI
AI
(CN) PIII
(US/EU) PIII
Neurology
AI
(JP) PIII
Gastrointestinal and Hepatic Disorders
ADA, AF
(JP) PIII
(JP) PII/III
Neurology
(US/EU) PII
(US) PII
Neurology
(US) PII
Vascular and Immunological Reaction
(JP) PII
(US) PII
(US/EU) PII
(US/EU) PII
(US) PII
(US/EU) PII
(JP/US/EU/AS) PII
(US/EU) PII
(US/EU) PII
(US/EU) PII
(US/EU) PII
(US/EU) PII
(US/EU) PII
(US/EU) PII
(JP) PII
(JP) PII
(US) PII
(JP) PII
Vascular and Immunological Reaction
New Approval
◎
Halaven (Second-line treatment for breast cancer)
Submitted / Preparing for Submission
cinitapride (Functional dyspepsia)
Aricept (Dementia with Lewy bodies)
Pariet (Prevention of recurrence of gastric and duodenal ulcers
during treatment with low-dosage aspirin, new 5 mg tablet)
Tambocor (Pediatric fine granule formulation)
◎
E7080 (Thyroid cancer)
Neurology
Oncology and Supportive Care
Clinical (Phase II or later)
Fycompa (Partial-onset seizures)
E5501 (Idiopathic thrombocytopenic purpura (ITP))
E5501 (Thrombocytopenia in chronic liver disease requiring
surgery)
Halaven (Third-line treatment for breast cancer )
E7080 (Hepatocellular carcinoma)
MORAb-003 (Platinum-sensitive ovarian cancer)
Fycompa (Primary generalized Tonic-Clonic seizures)
Halaven (Non–small cell lung cancer)
Halaven (Sarcoma)
Halaven (First-/second-line treatment for HER2-negative breast
cancer)
DC Bead (Transcatheter arterial embolization (TAE) of
hypervascular tumors)
Aricept (Severe Alzheimer’s disease)
Inovelon/Banzel (Pediatric Lennox-Gastaut syndrome)
Pariet (Maintenance therapy for proton pump inhibitor
(PPI)–resistant reflux esophagitis)
Aricept (Higher dose 23 mg tablet)
E0302 (Amyotrophic lateral sclerosis (ALS))
BAN2401 (Alzheimer’s disease)
E2006 (Insomnia)
E5501 (Thrombocytopenia during interferon therapy (both initiation
and maintenance) for hepatitis C)
E6005 (Atopic dermatitis)
E7016 (Melanoma)
E7080 (Endometrial cancer)
E7080 (Melanoma)
E7080 (Glioma)
E7080 (Non–small cell lung cancer, Third-line, mono-therapy)
E7080 (Non–small cell lung cancer, RET translocations)
E7820 (Colorectal cancer)
MORAb-003 (Non–small cell lung cancer)
MORAb-004 (Melanoma)
MORAb-004 (Colorectal cancer)
MORAb-004 (Sarcoma)
MORAb-009 (Mesothelioma)
Fycompa (Pediatric partial-onset seizures)
Aricept (Regression symptoms in people with Down syndrome)
Halaven (Sarcoma)
Ontak (Melanoma)
Pariet (Functional dyspepsia)
AI
AI
AI
AI
AI
Vascular and Immunological Reaction
Oncology and Supportive Care
Oncology and Supportive Care
Neurology
Oncology and Supportive Care
Oncology and Supportive Care
Neurology
Neurology
Neurology
Oncology and Supportive Care
Oncology and Supportive Care
Oncology and Supportive Care
Oncology and Supportive Care
Oncology and Supportive Care
Oncology and Supportive Care
Oncology and Supportive Care
Oncology and Supportive Care
Oncology and Supportive Care
Oncology and Supportive Care
Oncology and Supportive Care
Oncology and Supportive Care
Neurology
Neurology
Oncology and Supportive Care
Oncology and Supportive Care
Gastrointestinal and Hepatic Disorders
* AI: Additional Indication, ADA: Additional Dosage & Administration, AF: Additional Formulation
** P: Clinical Phase; JP: Japan, US: United States, EU: Europe, CN: China, AS: Asia (excluding Japan and China)
・ Regarding the aldose reductase inhibitor AS-3201, a Phase II/III study conducted in Europe and the United States was completed, however upon considering the further development
strategy based on results, the Company has decided to discontinue development.
◎ Development progress from April 2014 onwards
Reference Data [R&D Pipeline] 16
August 1, 2014 / Eisai Co., Ltd.
(1) Oncology and Supportive Care
Development Code: E7389 Generic Name: eribulin Product Name:
Halaven
Indications / Drug class: Anticancer agent / microtubule dynamics inhibitor
In-house
Description: A synthetic analog of halichondrin B derived from the marine sponge, Halichondria okadai. Showes an antitumor effect by
arresting the cell cycle through inhibition of the growth of microtubules. Currently being investigated as a potential treatment for breast
cancer and various other solid tumors. Approved in 54 countries including the United States, Singapore, European Union (EU) , Japan,
and Switzerland for breast cancer. Also approved in Europe as a second-line treatment for breast cancer in June 2014.
◎
Second-line treatment for breast cancer (Additional
Indication)
Third-line treatment for breast cancer
First-/second-line treatment for HER2-negative breast
cancer (Additional Indication)
EU: approved (June 2014)
Inj.
CN: PIII
Inj.
Submission Target: FY2015
US: PIII
Inj.

Non-small cell lung cancer (Additional Indication)

Sarcoma (Additional Indication)

Bladder cancer (Additional Indication)
US/EU: PI/PII
Inj.

Liposome formulation (Additional Formulation)
EU: PI
Inj.
Development Code: E7080 Generic Name:
JP/US/EU/AS: PIII
US/EU/AS: PIII
JP: PII
Submission Target: FY2014
Inj.
Submission Target: FY2015
Inj.
lenvatinib
Indications / Drug class: Anticancer agent / selective tyrosine kinase inhibitor with a novel
binding mode
In-house
Description: Selective tyrosine kinase inhibitor with a novel binding mode. Currently being investigated as a potential treatment for
various solid tumors.
◎
JP: submitted (June 2014)
Thyroid cancer
US/EU/AS: preparing for submission
Oral
Hepatocellular carcinoma
JP/US/EU/CN/AS: PIII
Oral

Endometrial cancer
US/EU: PII
Oral

Melanoma
US/EU: PII
Oral
Glioma
US: PII
Oral
Non-small cell lung cancer (Third-line, Mono therapy)
US/EU: PII
Oral
Non-small cell lung cancer (RET translocations)
JP/US/EU/AS: PII
Oral
Renal cell carcinoma
US/EU: PI/II
Oral
Development Code: MORAb-003 Generic Name: farletuzumab
Indications / Drug class: Anticancer agent / humanized anti-FRA monoclonal antibody
In-house
Description: A humanized IgG1 monoclonal antibody that targets folate receptor alpha (FRA). Expected to show an antitumor effect
against carcinomas that over-express FRA.

Platinum-sensitive ovarian cancer
JP/US/EU/AS: PIII
Inj.

Non-small cell lung cancer
US/EU: PII
Inj.
Development Code: MORAb-004
Indications / Drug class: Anticancer agent / humanized anti-endosialin monoclonal antibody
In-house
Description: A humanized lgG1 monoclonal antibody that targets Tumor Endothelial Marker 1 (TEM-1) / endosialin. Expected to show
an antitumor effect against carcinomas that express endosialin.
Melanoma
US/EU: PII
Inj.
Colorectal cancer
US/EU: PII
Inj.
Sarcoma
US/EU: PII
Inj.
◎ Development progress from April 2014 onwards
Reference Data [R&D Pipeline] 17
August 1, 2014 / Eisai Co., Ltd.
Development Code: MORAb-009 Generic Name: amatuximab
Indications / Drug class: Anticancer agent / chimeric anti-mesothelin monoclonal antibody
In-house
Description: A chimeric IgG1 monoclonal antibody that blocks the function of mesothelin. Expected to show an antitumor effect against
carcinomas that express mesothelin.

Mesothelioma
US/EU: PII
Inj.
Development Code: E7820
Indications / Drug class: Anticancer agent / alpha 2 integrin suppressant
In-house
Description: An angiogenesis inhibitor that suppresses the expression of alpha 2 integrin, a vascular endothelial cell adhesion molecule.

Colorectal cancer
US/EU: PII
Oral
Development Code: E7016
Indications / Drug class: Anticancer agent / poly (ADP-ribose) polymerase inhibitor
In-house
Description: Poly (ADP-ribose) polymerase (PARP) is an enzyme that is involved in DNA repair. PARP inhibitors exhibit an antitumor
effect by inhibiting DNA repair in tumor cells and are expected to enhance the effect of chemotherapy and radiotherapy, both of which
damage DNA.
Melanoma
US: PII
Development Code: E7272 Generic Name: denileukin
Oral
diftitox Product Name: Ontak
Indications / Drug class: Anticancer agent / interleukin-2 diphtheria toxin fusion protein
In-house
Description: A fusion protein that combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxins. Selectively binds to
IL-2 receptors on the cell surface, causing diphtheria toxins that have entered cells to inhibit protein synthesis. Already approved in the
United States as a treatment for CD25 (a component of the IL-2 receptor) positive cutaneous T-cell lymphoma.

Melanoma (Additional Indication)
US: PII
Development Code: E7040 Product Name: DC
Inj.
Bead
Indications / Drug class: Embolic bead / medical device
In-license (Biocompatibles)
Description: Contains hydrophilic microspherical particles produced from cross-linked polyvinyl alcohol polymer. These embolic beads
are injected through a catheter to selectively embolize targeted blood vessels. The beads are microscopic and uniformly spherical in
shape, allowing for sustained embolization of targeted vessels based on vascular diameter and tumor size. Approved in Japan as a
device for transcatheter arterial embolization (TAE) therapy in patients with hepatocellular carcinoma.
Transcatheter arterial embolization (TAE) of hypervascular
JP: PIII
tumors (Additional Indication)
Submission Target: FY2014
Embolic
Agent
Development Code: E7438
Anticancer agent (EZH2 inhibitor)
PI/II
In-license (Epizyme)
Oral
PI
In-license (Janssen Biotech)
Inj.
Development Code: MORAb-066
Anticancer agent (Antibody)
◎ Development progress from April 2014 onwards
Reference Data [R&D Pipeline] 18
August 1, 2014 / Eisai Co., Ltd.
(2) Neurology
Development Code: E2020 Generic Name: donepezil Product Name: Aricept
Indications / Drug class: Anti-Alzheimer’s agent
In-house
Description: Increases levels of the neurotransmitter acetylcholine in the brain by inhibiting its breakdown by the enzyme
acetylcholinesterase, thereby slowing the overall progression of symptoms associated with Alzheimer’s disease (AD). Currently
approved in more than 90 countries around the world for the treatment of mild to moderate AD. It is also approved as a treatment for
patients with severe AD in numerous countries including the United States, Japan, Canada, and several other Asian and Latin
American countries.


Dementia with Lewy bodies (Additional Indication)
JP: submitted (October 2013)
Oral
Severe Alzheimer’s disease (Additional Indication)
CN: PIII
Submission Target: FY2014
Oral
JP: PIII
Submission Target: FY2014
Oral
Higher dose 23 mg tablet (Additional Administration and ,
Formulation)
Regression symptoms in people with Down syndrome
(Additional Indication)
Transdermal formulation (E2022, Additional Formulation)
JP: PII
JP: PI
Oral
(Collaboration with Teikoku
Pharmaceuticals)
Patch
Development Code: E2007 Generic Name: perampanel Product Name: Fycompa
Indications / Drug class: Antiepileptic agent / AMPA receptor antagonist
In-house
Description: A selective antagonist against the AMPA receptor (a glutamate receptor subtype). Currently being investigated as a
potential adjunctive therapy for partial-onset seizures as well as a treatment for generalized seizures in patients with epilepsy. Approved
as an adjunctive therapy for partial-onset seizures in 39 countries including in Europe, the United States, and Canada.

Partial-onset seizures
JP/CN/AS: PIII
Submission Target: FY2015
Oral

Generalized seizures (Additional Indication)
JP/US/EU/AS: PIII
Submission Target: FY2014
Oral

Pediatric partial-onset seizures (Additional Indication)
US/EU: PII
Oral
・Simultaneous submission for generalized seizures and partial-onset seizures in Japan is scheduled for FY2015.
Development Code: E0302 Generic Name: mecobalamin
Indications / Drug class: Amyotrophic lateral sclerosis
In-house
Description: A mecobalamin (vitamin B12 coenzyme) formulation. Restores damaged peripheral nerves and is widely used for the
treatment of peripheral neuropathy. Currently being investigated as a potential treatment for amyotrophic lateral sclerosis (ALS).

Amyotrophic lateral sclerosis (ALS)
JP: PII/III
Submission Target: FY2014
Inj.
Development Code: E2080 Generic Name: rufinamide Product Name: Inovelon/Banzel
Indications / Drug class: Antiepileptic agent
In-license (Novartis)
Description: A triazole derivative that is structurally unrelated to currently marketed antiepileptic drugs (AEDs). Currently approved in
Japan, Europe and the United States as an adjunctive therapy to other AEDs in the treatment of Lennox-Gastaut syndrome (LGS), one
of the most severe and intractable forms of childhood-onset epilepsy. The product names are Inovelon in Japan and Europe and Banzel
in the United States.

Pediatric Lennox-Gastaut syndrome (LGS)
US/EU: PIII
(Additional Indication)
Oral
Development Code: BAN2401
Indications / Drug class: Anti-Alzheimer’s agent / humanized anti-A protofibrils monoclonal
antibody
In-license (BioArctic Neuroscience)
Description: A humanized lgG1 monoclonal antibody that targets amyloid beta (A) protofibrils. Expected to be effective in the treatment
of Alzheimer’s disease by halting disease progression through the elimination of A protofibrils reported to exhibit neurotoxicity.
US/EU: PII
Alzheimer’s disease
JP: PI
Inj.
◎ Development progress from April 2014 onwards
Reference Data [R&D Pipeline] 19
August 1, 2014 / Eisai Co., Ltd.
Development Code: E2006
Indications / Drug class: Anti-insomnia agent / orexin receptor antagonist
In-house
Description: Anti-insomnia agent with novel mechanism of action. By antagonizing the orexin receptors that maintain wakefulness, it is
expected to alleviate wakefulness and thereby induce natural sleep.
Insomnia
US: PII
Oral
Development Code: E2609
Alzheimer’s disease (BACE inhibitor)
PI
In-house
Oral
Development Code: APD356 Generic Name: lorcaserin Product Name: BELVIQ
Obesity
JP: PI
In-license (Arena Pharmaceuticals)
Oral
・Regarding the aldose reductase inhibitor AS-3201, a Phase II/III study of the compound conducted in Europe and the United States was
completed, however upon considering the further development strategy, the Company has decided to discontinue development.
(3) Vascular and Immunological Reaction
Generic Name: flecainide Product Name: Tambocor
Indications / Drug class: Anti-tachyarrhythmia agent
In-house
Description: Suppresses tachyarrhythmia by blocking cardiac sodium channels. The agent was approved for the treatment of
tachyarrhythmia (paroxysmal atrial fibrillation/flutter and ventricular tachycardia) in adults and tachyarrhythmia (paroxysmal atrial
fibrillation/flutter, paroxysmal superventricular tachycardia and ventricular tachycardia) in pediatric patients.
Pediatric fine granule formulation (Additional Formulation)
Development Code:
JP: submitted (January 2014)
Oral.
E5501/AKR-501 Generic Name: avatrombopag
Indications / Drug class: Treatment for thrombocytopenia / thrombopoietin receptor agonist
In-house
Description: A novel, oral thrombopoietin receptor agonist that stimulates platelet production. Expected to show effects against
conditions that are associated with thrombocytopenia.

Thrombocytopenia in chronic liver disease requiring surgery
JP/US/EU/AS: PIII

Idiopathic thrombocytopenic purpura (ITP)
US/EU/AS: PIII
Oral
US: PII
Oral

Thrombocytopenia during interferon therapy (both initiation and
maintenance) for hepatitis C
Submission Target: FY2015
Oral
・Japan was added to the global Phase III clinical study of thrombocytopenia in chronic liver disease requiring surgery.
Development Code: E6005
Indications / Drug class: Anti-atopic dermatitis / Phosphodiesterase 4 inhibitor
In-house
Description: Inhibits the activity of phosphodiesterase 4, a cyclic AMP-degrading enzyme that acts as an intracellular messenger.
Expected to be effective as a treatment to suppress the various symptoms associated with atopic disease.
Atopic dermatitis
JP: PII
Topical
Development Code: E6011
Autoimmune disorder/Inflammatory diseases
(anti Fractalkine antibody)
PI/II
In-house
Inj.
◎ Development progress from April 2014 onwards
Reference Data [R&D Pipeline] 20
August 1, 2014 / Eisai Co., Ltd.
Development Code: MORAb-022
Rheumatoid arthritis (antibody)
PI
In-house
Inj.
(4) Gastrointestinal and Hepatic Disorders
Development Code: E3810 Generic Name: rabeprazole Product Name: Pariet/Aciphex)
Indications / Drug class: Proton pump inhibitor
In-house
Description: A proton pump inhibitor approved for the treatment of gastric and duodenal ulcers, reflux esophagitis, eradication of
Helicobacter pylori infections and triple formulation packs (combination packs) for H. pylori eradication which contain rabeprazole,.etc.
Prevention of recurrence of gastric and duodenal ulcers during

treatment with low-dosage aspirin, new 5 mg tablet (Additional
JP: submitted (November 2013)
Oral
JP: PIII
Oral
JP: PII
Oral
Indication, Formulation)


Maintenance therapy for proton pump inhibitor (PPI)–resistant
reflux esophagitis (Additional Indication)
Functional dyspepsia (Additional Indication)
Generic Name: cinitapride
Indications / Drug class: Gastroprokinetic agent
In-license (Almirall)
Description: By stimulating 5-HT2 and 5-HT4 receptors found in the gastrointestinal tract, the agent increases acetylcholine release and
improves upper gastrointestinal motility. Its antidopaminergic effects also help stimulate the release of acetylcholine by blocking
dopamine receptors, thereby improving upper gastrointestinal function.
Functional dyspepsia
CN: submitted (October 2011)
Oral
◎ Development progress from April 2014 onwards
Reference Data [R&D Pipeline] 21
August 1, 2014 / Eisai Co., Ltd.