Eisai : FY 2020 (Ending March 31, 2021) First Quarter Financial Results Reference Data

Securities Code: 4523

FY 2020 (Ending March 31, 2021)

First Quarter Financial Results

Reference Data

August 3, 2020

Eisai Co., Ltd.

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https://www.eisai.com/

Forward-Looking Statements and Risk Factors

The materials and information provided in this announcement include current forecasts, targets, evaluations, estimates, assumptions that are accompanied by risks, and other matters that are based on uncertain factors. Accordingly, it is possible that actual results will deviate significantly from forecasts, etc., due to changes to a variety of factors. These risks and uncertainties include general industry and market conditions, fluctuation of interest rates and currency exchange rates, and other aspects of economic conditions in Japan and internationally.

Risks and uncertainties that could cause significant fluctuations in the results of the Group or have a material effect on investment decisions are as follows. However, these do not cover all of the risks and uncertainties faced by the Group, and it is possible that they will be affected in the future by other factors that cannot be foreseen, or are not deemed to be important, at this point in time.

These are judgments as of the time of the announcement, and statements in the text regarding the future are not guarantees that they will occur or be achieved.

Risks factors include risks related to management based on the Corporate Philosophy, risks related to establishment of AD franchise, risks related to maximization of the value of Lenvima, risks related to partnership model, risks related to digital transformation, risks related to uncertainties in new drug development, risks related to occurrences of side effects, risks related to product quality and stable supply, risks related to intellectual property, risks related to litigations, risks related to data reliability, risks related to medical cost containment measures, risks related to succession, risks related to information security, risks related to COVID-19, risks related to climate change, risks related to impairment of goodwill and intangible assets.

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.	Segment Information			--------------------	2
3.	Financial Results by Reporting Segment		--------------------	3
4.	Revenue from Major Products			--------------------	7
5.	Revenue Forecasts by Reporting Segment		--------------------	9
6.	Consolidated Statement of Comprehensive Income	--------------------	10
7.	Consolidated Statement of Cash Flows		--------------------	11
8.	Capital Expenditures, Depreciation and Amortization	--------------------	12
9.	Consolidated Statement of Financial Position	--------------------	12
10. Changes in Quarterly Results			--------------------	14
11. Major R&D Pipeline			--------------------	17
Currency Exchange Rates
			US	EU	UK	China
			(USD/JPY)	(EUR/JPY)	(GBP/JPY)	(RMB/JPY)
FY 2019 Q1	Quarterly Average Rate	109.90	123.48	141.16	16.07
		Quarter End Rate	107.79	122.49	136.57	15.69
FY 2019	Yearly Average Rate	108.73	120.81	138.24	15.60
Year End Rate	108.83	119.55	133.32	15.31
FY 2020 Q1	Quarterly Average Rate	107.62	118.47	133.52	15.17
		Quarter End Rate	107.74	121.08	132.51	15.23
FY 2020	Forecast Rate	105.00	117.00	130.00	14.60

• Eisai Co., Ltd. ("the Company") discloses its consolidated financial statements in accordance with the International Financial Reporting Standards (IFRS).
• The Eisai Group's ("the Group") business is comprised of pharmaceutical business and other business. The pharmaceutical business is organized into the following six reporting segments in this report: Japan, Americas (North America), China, EMEA (Europe, the Middle East, Africa, Russia, and Oceania), Asia and Latin America (primarily South Korea, Taiwan, Hong Kong, India, ASEAN, Central and South America), and OTC and others (Japan).
• All amounts are rounded to the nearest specified unit.

August 3, 2020 / Eisai Co., Ltd.

1. Consolidated Statement of Income

			FY 2019				FY 2020
	Q1		Ratio		Full year	Ratio	Q1		Ratio	YOY	Diff.
	(%)		(%)	(%)	(%)
Revenue	154.0	100.0		695.6	100.0	165.6	100.0	107.5	11.6
Cost of sales	42.9	27.9		175.7	25.3	38.3	23.1	89.3	(4.6)
Gross profit	111.1	72.1		519.9	74.7	127.3	76.9	114.6	16.2
Selling, general and administrative expenses	60.0	38.9		256.3	36.8	64.9	39.2	108.3	5.0
Selling expenses	24.7	16.0		107.2	15.4	28.2	17.0	114.2	3.5
Personnel expenses	21.1	13.7		88.1	12.7	22.0	13.3	104.6	1.0
Administrative and other expenses	14.2	9.2		61.0	8.8	14.7	8.9	103.3	0.5
Research and development expenses	29.4	19.1		140.1	20.1	30.5	18.4	103.7	1.1
Other income	4.8	3.1		6.4	0.9	0.7	0.4	14.9	(4.1)
Other expenses	0.7	0.4		4.4	0.6	0.4	0.3	65.2	(0.2)
Operating profit	25.8	16.8		125.5	18.0	32.1	19.4	124.4	6.3
Financial income	1.4	0.9		4.0	0.6	0.7	0.4	45.2	(0.8)
Financial costs	0.3	0.2		1.5	0.2	0.3	0.2	106.2	0.0
Profit before income taxes	27.0	17.5		128.1	18.4	32.4	19.6	120.3	5.5
Income taxes	4.9	3.2		5.6	0.8	7.7	4.6	158.0	2.8
Profit for the period	22.1	14.3		122.5	17.6	24.8	14.9	112.0	2.7
Profit for the period attributable to
Owners of the parent	21.7	14.1		121.8	17.5	24.4	14.8	112.7	2.8
Non-controlling interests	0.4	0.3		0.7	0.1	0.3	0.2	77.1	(0.1)
Comprehensive income for the period	3.1	2.0		96.2	13.8	23.7	14.3	772.0	20.6
Earnings per share (EPS, yen)	75.64		425.01	85.23
Dividend per share (DPS, yen)		－		160			－
Return on equity (ROE, %)		－		18.6			－
Dividends on equity ratio (DOE, %)		－		7.0			－

• Full year estimation for other income has had other expenses deducted from it.
• EPS: Earnings Per Share attributable to owners of the parent (basic).

Notes

(billions of yen)

FY 2020

Full year	Ratio
(est.)	(%)

719.0 100.0

171.5 23.9

547.5 76.1

294.5 41.0

• －
• －
• －

1. 23.0

1. 0.1

• －

88.0 12.2

• －
• －

90.0 12.5

• －

67.5 9.4

67.0 9.3

• －

233.00

160

9.7

6.7

Revenue	Continuous significant growth of the anticancer agent Lenvima: 34.7 billion yen (the same period in previous fiscal
	year: 24.8 billion yen)
	Transfer rights regarding the anticancer agent tazemetostat to Royalty Pharma (U.S.): 11.5 billion yen
Selling, general and administrative expenses	Shared profit of Lenvima paid to Merck & Co., Inc., Kenilworth, N.J., U.S.A.: 16.5 billion yen (the same period in
	previous fiscal year: 10.9 billion yen)
Research and development expenses	Aggressive resource investment in anti amyloid-beta protofibril antibody BAN2401
	Control of expenses using the partnership model (Partner's burden for major in-house products:
	16.6 billion yen (the same period in previous fiscal year: 18.0 billion yen))
Other income	Recording of gain on transfer of Elmed Eisai Co., Ltd. in the same period in previous fiscal year: 4.4 billion yen
Exchange rate effects	Revenue: -3.84 billion yen, operating profit: -1.13 billion yen
Exchange rate sensitivity	Revenue (U.S. dollars: -1.83 billion yen, Euro: -300 million yen, U.K. pounds: -60 million yen, Chinese renminbi:
(annual effect of 1 yen appreciation in currency value)	-6.29 billion yen)
	Operating profit (U.S. dollars: +180 million yen, Euro: -260 million yen, U.K. pounds: +70 million yen, Chinese
	renminbi: -3.53 billion yen)

Reference Data [Consolidated] 1

August 3, 2020 / Eisai Co., Ltd.

2. Segment Information

1. Revenue by Reporting Segment

(billions of yen)

	FY 2019		FY 2020
	Q1		Full year	Q1	YOY (%)	CER
		YOY (%)
Pharmaceutical Business Total	149.8		577.3	148.4	99.0	101.3
Japan pharmaceutical business	65.4		247.1	59.7	91.4	91.4
Americas pharmaceutical business	29.6		127.9	34.2	115.4	117.9
United States	29.3		126.5	33.8	115.3	117.8
China pharmaceutical business	22.1		77.0	23.8	107.9	114.3
EMEA pharmaceutical business	13.7		53.7	13.4	98.0	103.3
Asia and Latin America pharmaceutical business	12.6		46.6	11.1	88.1	92.0
OTC and others	6.5		24.9	6.1	94.7	94.7
Other business	4.2		118.4	17.2	412.1	423.4
Consolidated revenue	154.0		695.6	165.6	107.5	110.0

• Indicates revenue from external customers.
• CER=Constant Exchange Rates

2) Profit by Reporting Segment						(billions of yen)
		FY 2019			FY 2020
	Q1		Full year	Q1	YOY (%)	CER
		YOY (%)
Pharmaceutical Business Total		66.8		230.4	68.5	102.7	104.6
Japan pharmaceutical business		27.7		94.2	25.3	91.3	91.3
Americas pharmaceutical business		15.4		60.0	17.2	111.3	113.8
China pharmaceutical business		10.4		32.8	13.8	132.9	140.5
EMEA pharmaceutical business		6.7		23.0	6.6	98.3	97.6
Asia and Latin America pharmaceutical business		4.6		16.0	4.3	91.9	94.6
OTC and others		1.9		4.5	1.4	74.8	74.8
Other business		1.6		108.5	15.1	946.9	973.1
Research and development expenses		(29.4)		(140.1)	(30.5)	103.7	105.7
Group headquarters' management costs and other expenses#		(17.5)		(77.7)	(21.0)	120.4	120.2
Gain on sale of subsidiaries		4.4		4.4	－	－	－
Consolidated operating profit		25.8		125.5	32.1	124.4	128.7

• Includes the amount of profits and expenses shared under strategic collaborations with partners.

Reference Data [Consolidated] 2

August 3, 2020 / Eisai Co., Ltd.

3. Financial Results by Reporting Segment

1. Japan pharmaceutical business

					(billions of yen)
	FY 2019		FY 2020
	Q1		Full year	Q1	YOY (%)
Revenue	65.4		247.1	59.7	91.4
Segment profit	27.7		94.2	25.3	91.3
Japan prescription medicines - revenue from major products
Fully human anti-TNF-α monoclonal antibody	13.0		51.9	12.5	96.2
Humira
Pain treatment (neuropathic pain, fibromyalgia)	7.1		28.6	6.1	85.5
Lyrica
Anticancer agent	3.4		13.1	3.7	107.4
Lenvima
Insomnia treatment	3.3		12.6	3.6	110.0
Lunesta
Peripheral neuropathy treatment	3.8		13.9	3.3	85.0
Methycobal
Alzheimer's disease / Dementia with Lewy bodies treatment	4.1		13.3	2.9	69.2
Aricept
Proton pump inhibitor	3.3		10.6	2.2	68.0
Pariet#
Anticancer agent	2.6		9.2	2.2	86.5
Halaven
Antirheumatic agent	1.5		6.4	2.0	128.8
Careram
Anticancer agent	2.0		7.7	1.9	92.8
Treakisym
Elemental diet	1.7		6.4	1.7	98.4
Elental#
Antiepileptic agent	1.0		3.9	1.2	128.3
Fycompa
Chronic constipation treatment	0.8		3.6	1.1	150.9
Goofice#

• The revenue for Pariet includes the revenue for triple formulation packs for Helicobacter pylori eradication, Rabecure Pack 400/800 and Rabefine Pack.
• Co-promotionrevenue has been booked as revenue for Lyrica.

• EA Pharma product

Reference Data [Consolidated] 3

August 3, 2020 / Eisai Co., Ltd.

2) Americas pharmaceutical business (North America)

						(billions of yen)
		FY 2019		FY 2020
	Q1			Full year	Q1	YOY (%)
Revenue		29.6		127.9	34.2	115.4
						<117.9>
United States		29.3		126.5	33.8	115.3
						<117.8>
Segment profit		15.4		60.0	17.2	111.3
						<113.8>

Americas - revenue from major products

Anticancer agent		13.8	68.0	21.5	155.7
Lenvima					<159.1>
United States		13.7	67.6	21.4	155.5
	[Millions USD]	[125]	[622]	[199]	<158.8>
Antiepileptic agent		6.8	22.4	5.1	75.6
Banzel					<77.2>
United States		6.8	22.1	5.1	75.6
	[Millions USD]	[61]	[204]	[47]	<77.2>
Anticancer agent		3.7	14.7	3.2	86.9
Halaven					<88.8>
United States		3.6	14.3	3.1	87.4
	[Millions USD]	[32]	[132]	[29]	<89.3>
Antiepileptic agent		3.0	13.0	3.0	102.2
Fycompa					<104.5>
United States		2.9	12.5	2.9	101.7
	[Millions USD]	[26]	[115]	[27]	<103.9>
Proton pump inhibitor		0.9	4.0	0.8	85.2
AcipHex	[Millions USD]	[9]	[37]	[7]	<87.1>

• YOY percentage: figures shown in angle brackets "< >" exclude the effects of foreign exchange fluctuations.
• All the above revenue of AcipHex is in the United States.

Reference Data [Consolidated] 4

August 3, 2020 / Eisai Co., Ltd.

3) China pharmaceutical business

							(billions of yen)
			FY 2019		FY 2020
		Q1			Full year	Q1	YOY (%)
Revenue			22.1		77.0	23.8	107.9
							<114.3>
Segment profit			10.4		32.8	13.8	132.9
							<140.5>
China - revenue from major products
Peripheral neuropathy treatment			6.4		20.1	6.9	107.7
Methycobal	[Millions RMB]		[398]		[1,290]	[454]	<114.1>
Anticancer agent			3.5		13.3	4.2	118.8
Lenvima	[Millions RMB]		[218]		[850]	[275]	<125.9>
Liver disease / Allergic disease agents			2.4		10.3	2.4	99.6
Stronger Neo-Minophagen C and Glycyron Tablets	[Millions RMB]		[149]		[660]	[158]	<105.5>
Alzheimer's disease treatment			2.8		9.7	2.2	79.2
Aricept	[Millions RMB]		[173]		[623]	[145]	<83.9>
Proton pump inhibitor			1.8		5.0	1.7	94.7
Pariet	[Millions RMB]		[113]		[323]	[113]	<100.3>
Anticancer agent			－		0.4	0.1	－
Halaven	[Millions RMB]		－		[25]	[8]	<－>
Antiepileptic agent			－		0.1	0.1	－
Fycompa	[Millions RMB]		－		[4]	[6]	<－>

• YOY percentage: figures shown in angle brackets "< >" exclude the effects of foreign exchange fluctuations.

1. EMEA pharmaceutical business (Europe, the Middle East, Africa, Russia and Oceania)

						(billions of yen)
		FY 2019		FY 2020
	Q1			Full year	Q1	YOY (%)
Revenue		13.7		53.7	13.4	98.0
						<103.3>
Segment profit		6.7		23.0	6.6	98.3
						<97.6>
EMEA - revenue from major products
Anticancer agent		3.0		12.7	3.9	131.2
Lenvima/Kisplyx						<138.9>
Anticancer agent		3.9		13.8	3.2	80.6
Halaven						<85.9>
Antiepileptic agent		1.7		7.1	1.7	99.4
Fycompa						<104.3>
Antiepileptic agent		1.6		6.5	1.6	103.2
Zebinix						<107.8>
Antiepileptic agent		1.0		3.9	0.8	78.5
Zonegran						<82.4>
Antiepileptic agent		0.6		2.4	0.6	91.5
Inovelon						<96.0>

* YOY percentage: figures shown in angle brackets "< >" exclude the effects of foreign exchange fluctuations.

Reference Data [Consolidated] 5

August 3, 2020 / Eisai Co., Ltd.

5) Asia and Latin America pharmaceutical business

					(billions of yen)
		FY 2019	FY 2020
	Q1		Full year	Q1	YOY (%)
Revenue		12.6	46.6	11.1	88.1
					<92.0>
Segment profit		4.6	16.0	4.3	91.9
					<94.6>

Asia and Latin America - revenue from major products

Alzheimer's disease / Dementia with Lewy bodies treatment	2.9	10.8	2.6	90.5
Aricept				<94.6>
Fully human anti-TNF-α monoclonal antibody	3.1	9.6	2.0	65.6
Humira				<70.1>
Anticancer agent	1.0	4.8	1.4	138.6
Lenvima				<144.1>
Proton pump inhibitor	1.2	4.2	1.3	105.0
Pariet				<108.9>
Anticancer agent	0.8	2.1	0.7	89.1
Halaven				<93.6>
Peripheral neuropathy treatment	0.7	3.0	0.6	81.4
Methycobal				<83.0>
Antiepileptic agent	0.3	1.1	0.3	115.2
Fycompa				<119.0>

• YOY percentage: figures shown in angle brackets "< >" exclude the effects of foreign exchange fluctuations.
• Indication of Aricept for the treatment of dementia with Lewy bodies is approved only in Japan, the Philippines and Thailand.

1. OTC and Others (Japan)

					(billions of yen)
	FY 2019	FY 2020
	Q1		Full year	Q1	YOY (%)
Revenue	6.5		24.9	6.1	94.7
Segment profit	1.9		4.5	1.4	74.8
OTC and others, revenue of main products
Vitamin B2 preparation, "Chocola BB Plus," etc.	4.3		15.5	3.1	72.1
Chocola BB Group

Reference Data [Consolidated] 6

August 3, 2020 / Eisai Co., Ltd.

4. Revenue from Major Products

1) Neurology Products				(billions of yen)
		FY 2019	FY 2020
	Q1		Full year	Q1		YOY (%)
Neurology Products Total		50.3	183.3	43.8	87.2
					<89.1>
Methycobal (Peripheral neuropathy treatment)		11.1	38.0	10.9	98.2
					<102.0>
Japan		3.8	13.9	3.3	85.0
China		6.4	20.1	6.9	107.7
					<114.1>
Asia and Latin America		0.7	3.0	0.6	81.4
					<83.0>
Aricept (Alzheimer's disease / Dementia with Lewy bodies treatment)		10.0	34.9	7.8	78.2
					<80.7>
Japan		4.1	13.3	2.9	69.2
China		2.8	9.7	2.2	79.2
					<83.9>
Asia and Latin America		2.9	10.8	2.6	90.5
					<94.6>
Fycompa (Antiepileptic agent)		6.0	25.3	6.4	107.6
					<110.5>
Japan		1.0	3.9	1.2	128.3
Americas		3.0	13.0	3.0	102.2
					<104.5>
China		－	0.1	0.1		－
						<－>
EMEA		1.7	7.1	1.7	99.4
					<104.3>
Asia and Latin America		0.3	1.1	0.3	115.2
					<119.0>
Lyrica (Pain treatment [neuropathic pain, fibromyalgia]) - Japan		7.1	28.6	6.1	85.5
Inovelon/Banzel (Antiepileptic agent)		7.6	25.4	5.9	77.3
					<79.2>
Americas		6.8	22.4	5.1	75.6
					<77.2>
EMEA		0.6	2.4	0.6	91.5
					<96.0>
Lunesta (Insomnia treatment) - Japan		3.3	12.6	3.6	110.0
Zebinix (Antiepileptic agent) - EMEA		1.6	6.5	1.6	103.2
					<107.8>
Zonegran (Antiepileptic agent)		1.2	4.5	1.0	81.9
					<85.9>
EMEA		1.0	3.9	0.8	78.5
					<82.4>
Other		2.5	7.6	0.6	23.6
					<24.1>

• YOY percentage: figures shown in angle brackets "< >" exclude the effects of foreign exchange fluctuations.
• Indication of Aricept for the treatment of dementia with Lewy bodies is approved only in Japan, the Philippines and Thailand.
• Co-promotionrevenue has been booked as revenue for Lyrica.

Reference Data [Consolidated] 7

August 3, 2020 / Eisai Co., Ltd.

2) Oncology Products

(billions of yen)

	FY 2019	FY 2020
	Q1		Full year	Q1	YOY (%)
Oncology Products Total	39.6		165.9	47.7	120.4
					<124.0>
Lenvima/Kisplyx (Anticancer agent)	24.8		111.9	34.7	140.2
					<144.2>
Japan	3.4		13.1	3.7	107.4
Americas	13.8		68.0	21.5	155.7
					<159.1>
China	3.5		13.3	4.2	118.8
					<125.9>
EMEA	3.0		12.7	3.9	131.2
					<138.9>
Asia and Latin America	1.0		4.8	1.4	138.6
					<144.1>
Halaven (Anticancer agent)	10.9		40.2	9.4	85.8
					<88.8>
Japan	2.6		9.2	2.2	86.5
Americas	3.7		14.7	3.2	86.9
					<88.8>
China	－		0.4	0.1	－
					<－>
EMEA	3.9		13.8	3.2	80.6
					<85.9>
Asia and Latin America	0.8		2.1	0.7	89.1
					<93.6>
Treakisym/Symbenda (Anticancer agent)	2.1		8.0	2.0	92.0
					<92.2>
Other	1.8		5.8	1.7	92.4
					<96.3>

* YOY percentage: figures shown in angle brackets "< >" exclude the effects of foreign exchange fluctuations.

Reference Data [Consolidated] 8

August 3, 2020 / Eisai Co., Ltd.

5. Revenue Forecasts by Reporting Segment (FY 2020)

							(billions of yen)
		FY 2019	FY 2020
		Q1		Full year	Q1		Full year (est.)
Japan (Prescription Medicines)	65.4		247.1	59.7		254.0
	Fully human anti-TNF-α monoclonal antibody
	Humira	13.0		51.9	12.5		52.0
	Anticancer agent
	Lenvima	3.4		13.1	3.7		15.0
	Insomnia treatment
	Lunesta	3.3		12.6	3.6		13.5
	Peripheral neuropathy treatment
	Methycobal	3.8		13.9	3.3		12.0
	Alzheimer's disease / Dementia with Lewy bodies treatment
	Aricept	4.1		13.3	2.9		10.0
	Antiepilepsy agent
	Fycompa	1.0		3.9	1.2		10.0
	Anticancer agent
	Halaven	2.6		9.2	2.2		9.5
	Antirheumatic agent
	Careram	1.5		6.4	2.0		8.5
	Proton pump inhibitor
	Pariet#	3.3		10.6	2.2		7.5
	Chronic constipation treatment
	Goofice#	0.8		3.6	1.1		6.5
Americas	29.6		127.9	34.2		154.0
United States	29.3		126.5	33.8		152.0
China	22.1		77.0	23.8		80.0
EMEA	13.7		53.7	13.4		56.0
Asia and Latin America	12.6		46.6	11.1		47.0
OTC and others (Japan)	6.5		24.9	6.1		26.0
	Vitamin B2 preparation, "Chocola BB Plus," etc.	4.3		15.5	3.1		13.5
	Chocola BB Group
Other	4.2		118.4	17.2		102.0
Consolidated revenue	154.0		695.6	165.6		719.0
Global revenue from major products
	Lenvima/Kisplyx	24.8		111.9	34.7		158.0
	Japan	3.4		13.1	3.7		15.0
	Americas	13.8		68.0	21.5		101.0
	China	3.5		13.3	4.2		19.0
	EMEA	3.0		12.7	3.9		17.0
	Asia and Latin America	1.0		4.8	1.4		6.0
	Halaven	10.9		40.2	9.4		42.0
	Japan	2.6		9.2	2.2		9.5
	Americas	3.7		14.7	3.2		14.0
	China	－		0.4	0.1		2.0
	EMEA	3.9		13.8	3.2		13.5
	Asia and Latin America	0.8		2.1	0.7		3.0
	Fycompa	6.0		25.3	6.4		34.0
	Japan	1.0		3.9	1.2		10.0
	Americas	3.0		13.0	3.0		14.0
	China	－		0.1	0.1		0.5
	EMEA	1.7		7.1	1.7		8.0
	Asia and Latin America	0.3		1.1	0.3		1.5
	Aricept	10.0		34.9	7.8		35.0
	Pariet/AcipHex	7.3		24.1	6.1		24.0

• The revenue for Pariet includes the revenue for triple formulation packs for Helicobacter pylori eradication, Rabecure Pack 400/800 and Rabefine Pack.
  # EA Pharma product

Reference Data [Consolidated] 9

August 3, 2020 / Eisai Co., Ltd.

6. Consolidated Statement of Comprehensive Income

(billions of yen)

	FY 2019		FY 2020
	Q1		Full year	Q1	YOY (%)	Diff.
Profit for the period	22.1		122.5	24.8	112.0	2.7
Other comprehensive income (loss)
Items that will not be reclassified to profit or loss
Financial assets measured at fair value through other comprehensive	(2.5)		(6.2)	1.1	－	3.6
income (loss)
Remeasurements of defined benefit plans	－		(2.9)	－	－	－
Subtotal	(2.5)		(9.1)	1.1	－	3.6
Items that may be reclassified subsequently to profit or loss
Exchange differences on translation of foreign operations	(16.5)		(17.4)	(2.2)	－	14.4
Cash flow hedges	0.0		0.2	0.0	268.6	0.0
Subtotal	(16.5)		(17.2)	(2.1)	－	14.4
Total other comprehensive income (loss), net of tax	(19.0)		(26.3)	(1.0)	－	18.0
Comprehensive income (loss) for the period	3.1		96.2	23.7	772.0	20.6
Comprehensive income (loss) for the period attributable to
Owners of the parent	2.6		95.5	23.4	883.6	20.7
Non-controlling interests	0.4		0.7	0.3	78.0	(0.1)

Reference Data [Consolidated] 10

August 3, 2020 / Eisai Co., Ltd.

7. Consolidated Statement of Cash Flows

			(billions of yen)
	FY 2019	FY 2020
	Q1	Q1	Diff.
Operating activities
Profit before income taxes	27.0	32.4	5.5
Depreciation and amortization	8.3	8.7	0.4
(Increase) decrease in working capital	(28.1)	(22.9)	5.2
Interest and dividends received	1.4	0.7	(0.7)
Interest paid	(0.1)	(0.3)	(0.1)
Income taxes paid	(7.0)	(7.1)	(0.1)
Other	(5.5)	(1.5)	3.9
Net cash from (used in) operating activities	(4.1)	10.0	14.1
Investing activities
Purchases of property, plant and equipment	(4.5)	(8.8)	(4.3)
Proceeds from sale of property, plant and equipment	0.8	0.0	(0.8)
Purchases of intangible assets	(22.0)	(3.2)	18.7
Proceeds from sale of subsidiaries	5.8	－	(5.8)
Purchases of financial assets	(0.7)	(0.6)	0.1
Proceeds from sale and redemption of financial assets	0.1	0.0	(0.0)
Subtotal	(20.5)	(12.6)	7.8
Payments of time deposits exceeding three months	(0.0)	(0.0)	0.0
Proceeds from redemption of time deposits exceeding three months	0.5	0.1	(0.4)
Other	(0.2)	0.1	0.2
Net cash from (used in) investing activities	(20.1)	(12.5)	7.6
Financing activities
Net increase (decrease) in short-term borrowings	(9.0)	－	9.0
Repayments of lease liabilities	(2.3)	(2.4)	(0.1)
Dividends paid	(22.9)	(22.9)	(0.0)
Other	(0.0)	(0.1)	(0.1)
Net cash from (used in) financing activities	(34.2)	(25.4)	8.8
Effect of exchange rate change on cash and cash equivalents	(8.0)	(0.1)	7.9
Net increase (decrease) in cash and cash equivalents	(66.4)	(27.9)	38.5
Cash and cash equivalents at beginning of period	291.9	254.2	(37.7)
Cash and cash equivalents at end of period	225.5	226.3	0.8
Free cash flows	(24.5)	(2.6)	21.9

* "Free cash flows" = "Net cash from operating activities" - "Capital expenditures (cash basis)"

Notes

■ Net cash from (used in) operating activities Increase in profit before income taxes

■Net cash from (used in) investing activities

Capital expenditures decreased mainly due to decreases in purchases of intangible assets

■Net cash from (used in) financing activities Dividends have been paid

Reference Data [Consolidated] 11

August 3, 2020 / Eisai Co., Ltd.

8. Capital Expenditures, Depreciation and Amortization

							(billions of yen)
		FY 2019			FY 2020
	Q1		Full year	Q1	Diff.		Full year (est.)
Capital expenditures (cash basis)		26.5	50.2	12.1	(14.4)		56.0
Property, plant and equipment		4.5	15.3	8.8	4.3		21.0
Intangible assets		22.0	35.0	3.2	(18.7)		35.0
Depreciation and amortization		8.3	33.7	8.7	0.4		35.0
Property, plant and equipment		4.4	17.8	4.7	0.3		18.0
Intangible assets		3.9	15.9	4.0	0.1		17.0

9. Consolidated Statement of Financial Position

(billions of yen)

	FY 2019		FY 2020
	March 31, 2020	Ratio (%)	June 30, 2020	Ratio (%)	% change	Diff.
Assets
Non-current assets
Property, plant and equipment	144.6	13.6	144.3	13.9	99.8	(0.3)
Goodwill	168.7	15.9	167.0	16.1	99.0	(1.7)
Intangible assets	106.1	10.0	103.5	9.9	97.5	(2.6)
Other financial assets	39.8	3.7	42.3	4.1	106.4	2.5
Other assets	15.1	1.4	14.4	1.4	95.0	(0.8)
Deferred tax assets	66.4	6.3	67.6	6.5	101.8	1.2
Total non-current assets	540.7	50.9	539.0	51.8	99.7	(1.7)
Current assets
Inventories	65.7	6.2	70.9	6.8	107.9	5.2
Trade and other receivables	180.0	16.9	184.0	17.7	102.2	4.0
Other financial assets	1.6	0.1	0.7	0.1	42.9	(0.9)
Other assets	19.8	1.9	19.4	1.9	97.5	(0.5)
Cash and cash equivalents	254.2	23.9	226.3	21.8	89.0	(27.9)
Total current assets	521.4	49.1	501.2	48.2	96.1	(20.2)
Total assets	1,062.1	100.0	1,040.3	100.0	97.9	(21.8)
Notes
■ Assets
(Trade and other receivables)	Increase in accounts receivable - trade following the increase in revenue
(Cash and cash equivalents)	Decrease due to payment of trade and other payables

Reference Data [Consolidated] 12

August 3, 2020 / Eisai Co., Ltd.

					(billions of yen)
	FY 2019		FY 2020
	March 31,	Ratio (%)	June 30,	Ratio (%)	% change	Diff.
	2020	2020
Equity
Equity attributable to owners of the parent
Share capital	45.0	4.2	45.0	4.3	100.0	－
Capital surplus	77.6	7.3	77.6	7.5	100.0	(0.0)
Treasury shares	(34.3)	(3.2)	(34.3)	(3.3)	99.8	0.1
Retained earnings	505.4	47.6	508.0	48.8	100.5	2.6
Other components of equity	84.5	8.0	82.4	7.9	97.5	(2.1)
Total equity attributable to owners of the parent	678.1	63.8	678.6	65.2	100.1	0.5
Non-controlling interests	24.5	2.3	24.7	2.4	100.7	0.2
Total equity	702.6	66.2	703.3	67.6	100.1	0.7
Liabilities
Non-current liabilities
Borrowings	54.9	5.2	55.0	5.3	100.0	0.0
Other financial liabilities	36.6	3.4	35.6	3.4	97.4	(1.0)
Provisions	1.3	0.1	1.4	0.1	101.4	0.0
Other liabilities	14.1	1.3	13.2	1.3	93.8	(0.9)
Deferred tax liabilities	0.6	0.1	0.3	0.0	52.4	(0.3)
Total non-current liabilities	107.5	10.1	105.5	10.1	98.1	(2.1)
Current liabilities
Borrowings	35.0	3.3	35.0	3.4	100.0	0.0
Trade and other payables	76.9	7.2	61.9	5.9	80.5	(15.0)
Other financial liabilities	25.5	2.4	21.3	2.0	83.5	(4.2)
Income taxes payable	5.4	0.5	6.3	0.6	117.8	1.0
Provisions	18.7	1.8	17.8	1.7	95.0	(0.9)
Other liabilities	90.5	8.5	89.2	8.6	98.6	(1.2)
Total current liabilities	252.0	23.7	231.5	22.3	91.9	(20.4)
Total liabilities	359.5	33.8	337.0	32.4	93.7	(22.5)
Total equity and liabilities	1,062.1	100.0	1,040.3	100.0	97.9	(21.8)
Notes
■ Equity
(Retained earnings)	Keep the same level as the end of previous fiscal year due to recording profit
	for the period and dividends paid
■ Liabilities
(Trade and other payables)	Decrease mainly due to accounts payable - other
(Other financial liabilities - current)	Decrease mainly due to the amortization of deposits received (reimbursement
	for research and development payment from Merck & Co., Inc., Kenilworth,
	N.J., U.S.A.)

Reference Data [Consolidated] 13

August 3, 2020 / Eisai Co., Ltd.

10. Changes in Quarterly Results

1) Income Statement					(billions of yen)
		FY 2019			FY 2020
	Q1	Q2	Q3	Q4	Q1
Revenue	154.0	145.3	186.8	209.6	165.6
Cost of sales	42.9	40.3	44.0	48.5	38.3
Gross profit	111.1	105.0	142.8	161.0	127.3
Selling, general and administrative expenses	60.0	60.5	68.0	67.9	64.9
Selling expenses	24.7	25.8	29.4	27.4	28.2
Personnel expenses	21.1	20.8	24.2	22.0	22.0
Administrative and other expenses	14.2	13.9	14.4	18.5	14.7
Research and development expenses	29.4	38.6	35.0	37.1	30.5
Other income	4.8	0.6	1.0	0.0	0.7
Other expenses	0.7	0.2	(0.5)	4.0	0.4
Operating profit	25.8	6.2	41.3	52.2	32.1
Financial income	1.4	0.9	1.1	0.6	0.7
Financial costs	0.3	0.3	0.3	0.6	0.3
Profit before income taxes	27.0	6.8	42.1	52.3	32.4
Income taxes	4.9	1.5	(4.5)	3.7	7.7
Profit for the period	22.1	5.3	46.5	48.6	24.8
Profit for the period attributable to
Owners of the parent	21.7	5.3	46.3	48.5	24.4
Non-controlling interests	0.4	(0.1)	0.3	0.1	0.3
Comprehensive income for the period	3.1	1.6	58.1	33.4	23.7
Earnings per share (EPS, yen)	75.64	18.58	161.46	169.31	85.23

* EPS: Earnings Per Share attributable to owners of the parent (basic).

2) Cash Flows

(billions of yen)

		FY 2019			FY 2020
	Q1	Q2	Q3	Q4	Q1
Cash flow from operating activities	(4.1)	12.5	20.8	73.6	10.0
Cash flow from investing activities	(20.1)	(3.5)	(2.9)	(1.2)	(12.5)
Cash flow from financing activities	(34.2)	(16.3)	(27.1)	(26.0)	(25.4)
Cash and cash equivalents at the end of period	225.5	215.4	212.5	254.2	226.3
Free cash flow	(24.5)	8.6	13.8	70.4	(2.6)

* "Free cash flow" = "Net cash from operating activities" - "Capital expenditures (cash basis)"

Reference Data [Consolidated] 14

August 3, 2020 / Eisai Co., Ltd.

3) Capital Expenditures, Depreciation and Amortization

(billions of yen)

				FY 2019			FY 2020
	Q1		Q2		Q3		Q4	Q1
Capital expenditures (cash basis)		26.5		4.5		6.8	12.4	12.1
Property, plant and equipment		4.5		2.6		2.6	5.6	8.8
Intangible assets		22.0		1.9		4.2	6.9	3.2
Depreciation and amortization		8.3		8.2		8.6	8.6	8.7
Property, plant and equipment		4.4		4.3		4.5	4.6	4.7
Intangible assets		3.9		3.9		4.1	4.0	4.0

4) Financial Positions

(billions of yen)

	Jun. 30,	Sept. 30,	Dec. 31,	Mar. 31,	Jun. 30,
	2019	2019	2019	2020	2020
Total assets	1,026.2	1,010.2	1,051.4	1,062.1	1,040.3
Equity	632.1	633.8	669.0	702.6	703.3
Attributable to owners of the parent	607.8	609.7	644.6	678.1	678.6
Liabilities	394.1	376.3	382.4	359.5	337.0
Borrowings	129.9	115.4	113.9	89.9	89.9
Ratio of equity attributable to owners of the parent (%)	59.2	60.4	61.3	63.8	65.2
Net debt equity ratio (times)	(0.24)	(0.24)	(0.22)	(0.29)	(0.25)

* "Net debt equity ratio (Net DER)" = ("Interest-bearing debt" ("Borrowings") - "Cash and cash equivalents" -

"Time deposits exceeding three months, etc." - "Investment securities held by the parent") / "Equity attributable to owners of the parent"

Reference Data [Consolidated] 15

August 3, 2020 / Eisai Co., Ltd.

5) Changes in Quarterly Revenue from Major Products

(1) Neurology Products

(billions of yen)

		FY 2019			FY 2020
	Q1	Q2	Q3	Q4	Q1
Neurology Total	50.3	45.7	48.8	38.5	43.8
Methycobal (Peripheral neuropathy treatment)	11.1	10.6	10.0	6.3	10.9
Japan	3.8	3.5	3.7	2.8	3.3
China	6.4	6.1	5.4	2.3	6.9
Asia and Latin America	0.7	0.8	0.8	0.7	0.6
Aricept (Alzheimer's disease / Dementia with Lewy bodies treatment)	10.0	9.2	9.2	6.6	7.8
Japan	4.1	3.3	3.5	2.3	2.9
China	2.8	3.1	2.7	1.1	2.2
Asia and Latin America	2.9	2.6	2.7	2.6	2.6
Fycompa (Antiepileptic agent)	6.0	5.9	6.9	6.5	6.4
Japan	1.0	1.0	1.1	0.9	1.2
Americas	3.0	3.0	3.8	3.3	3.0
China	－	－	0.0	0.1	0.1
EMEA	1.7	1.6	1.8	2.0	1.7
Asia and Latin America	0.3	0.3	0.3	0.3	0.3
Lyrica (Pain treatment [neuropathic pain, fibromyalgia]) - Japan	7.1	6.8	8.2	6.5	6.1
Inovelon/Banzel (Antiepileptic agent)	7.6	5.4	6.3	6.1	5.9
Americas	6.8	4.7	5.5	5.4	5.1
EMEA	0.6	0.6	0.6	0.6	0.6
Lunesta (Insomnia treatment) - Japan	3.3	3.1	3.5	2.8	3.6
Zebinix (Antiepileptic agent) - EMEA	1.6	1.5	1.6	1.8	1.6
Zonegran (Antiepileptic agent)	1.2	1.1	1.0	1.2	1.0
EMEA	1.0	1.0	0.9	1.0	0.8
Other	2.5	2.1	2.2	0.7	0.6

• Indication of Aricept for the treatment of dementia with Lewy bodies is approved only in Japan, the Philippines and Thailand.
• Co-promotionrevenue has been booked as revenue for Lyrica.

(2) Oncology Products				(billions of yen)
		FY 2019			FY 2020
	Q1	Q2	Q3	Q4	Q1
Oncology Total	39.6	39.0	43.4	43.9	47.7
Lenvima/Kisplyx (Anticancer agent)	24.8	25.8	30.0	31.4	34.7
Japan	3.4	3.5	3.3	2.9	3.7
Americas	13.8	14.5	18.8	20.9	21.5
China	3.5	3.6	3.6	2.6	4.2
EMEA	3.0	2.8	3.2	3.7	3.9
Asia and Latin America	1.0	1.3	1.2	1.3	1.4
Halaven (Anticancer agent)	10.9	9.7	9.9	9.7	9.4
Japan	2.6	2.5	2.3	1.9	2.2
Americas	3.7	3.9	3.7	3.5	3.2
China	－	－	0.1	0.3	0.1
EMEA	3.9	3.2	3.3	3.4	3.2
Asia and Latin America	0.8	0.2	0.5	0.6	0.7
Treakisym/Symbenda (Anticancer agent)	2.1	2.2	2.1	1.6	2.0
Other	1.8	1.3	1.4	1.3	1.7

Reference Data [Consolidated] 16

August 3, 2020 / Eisai Co., Ltd.

Oral

11．Major R&D Pipeline

(1) Neurology

Development Code: E2007 Generic Name: perampanel Product Name: Fycompa	In-house
Indications / Drug class: Antiepileptic agent / AMPA receptor antagonist	Oral

Description: A selective antagonist against the AMPA receptor (a glutamate receptor subtype). Approved as an adjunctive therapy for partial- onset seizures in over 65 countries including Japan, the United States, China and other countries in Europe and in Asia. Approved for monotherapy and adjunctive use in the treatment of partial onset seizures (with or without secondarily generalized seizures) in patients 4 years of age and older in Japan and the United States. Also approved as an adjunctive therapy for primary generalized tonic-clonic seizures in over 65 countries including Japan, the United States, and other countries in Europe and in Asia. In the United States and other countries in Europe, an oral suspension formulation has been approved. A fine granule formulation has been approved in Japan.

	Pediatric epilepsy (Additional Dosage and Administration)	Study 311	EU	Submitted (February, 2019)
	Lennox-Gastaut syndrome (Additional Indication)	Study 338	JP/US/EU	PIII
	Development Code: ME2125 Generic Name: safinamide	Product Name: Equfina		In-license (Meiji Seika Pharma)
	Indications / Drug class: Anti-Parkinson's disease agent / MAO-B inhibitor		Oral

Description: A selective monoamine oxidase B (MAO-B) inhibitor, which reduces the degradation of secreted dopamine, helping to maintain the density of dopamine in the brain. Meiji Seika Pharma holds the manufacturing and marketing approval for safinamide in Japan, and Eisai has the exclusive rights to market the safinamide in Japan as well as to develop and market safinamide in Asia.

Improvement of wearing-off phenomenon in patients	with	―	South Korea ◎	Approved (June, 2020)
Parkinson's disease
Development Code: E2006 Generic Name: lemborexant	Product Name: Dayvigo	In-house

Indications / Drug class: Insomnia treatment / Orexin receptor antagonist

Description: An orexin receptor antagonist that blocks the receptors involved in the regulation of sleep and wakefulness. It is expected to alleviate wakefulness, thereby facilitating onset and maintenance of sleep. It has been approved for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adults in the United States. It has been approved for the treatment of insomnia in Japan. In addition, development for Irregular sleep-wake rhythm disorder and Alzheimer's disease dementia is ongoing.

Irregular sleep-wake rhythm disorder and Alzheimer's disease	Study 202	JP/US	PII
dementia (Additional Indication)
Development Code: BIIB037 Generic Name: aducanumab			Co-development (Biogen Inc.)
Indications / Drug class: Disease modifying treatment for Alzheimer's disease / anti-Aβ monoclonal antibody	Injection

Description: A human recombinant monoclonal antibody (mAb) that is derived from a de-identified library of B cells collected from healthy elderly subjects with no signs of cognitive impairment or cognitively impaired elderly subjects with unusually slow cognitive decline using Neurimmune's technology platform called Reverse Translational Medicine (RTM). Biogen Inc. licensed aducanumab from Neurimmune. Aducanumab is thought to target aggregated forms of amyloid beta (Aβ) including soluble oligomers and insoluble fibrils, which can form into amyloid plaque in Alzheimer's disease patients. Biogen Inc. conducted a new analysis of larger dataset after consulting with the United States Food and Drug Administration (FDA) regarding the Phase III clinical studies and the submission of Biologics License Application (BLA) to FDA was completed in July 2020. Joint development with Biogen Inc.

Alzheimer's disease	ENGAGE/	US	◎	Submitted (July, 2020)
EMERGE Studies	EU	◎	Preparation for submission

JP: Japan, US: the United States, EU: Europe, CH: China, P: (Clinical trial) Phase

◎：Development progress from April 2020 onwards

Reference Data [R&D Pipeline] 17

August 3, 2020 / Eisai Co., Ltd.

Development Code: BAN2401		In-license (BioArctic AB)
β	protofibril antibody	Injection
Indications / Drug class: Disease modifying treatment for Alzheimer's disease / anti-A

Description: An lgG1 antibody that targets amyloid beta (Aβ) protofibrils. Expected to be effective in the treatment of Alzheimer's disease (AD) by halting disease progression through the elimination of neurotoxic Aβ protofibrils. Joint development with Biogen. Inc. Phase III clinical study AHEAD 3-45 for preclinical AD was initiated in collaboration with the Alzheimer's Clinical Trials Consortium (ACTC).

Early AD	Study 301	(Clarity AD)	JP/US/	PIII
EU/CH
◎ Preclinical AD	Study 303	(AHEAD 3-45) JP/US/EU	PIII
Development Code: E2027				In-house
Indications / Drug class: Treatment for dementia with Lewy bodies / PDE 9 inhibitor		Oral

Description: A selective phosphodiesterase (PDE) 9 inhibitor that reduces the degradation of cyclic GMP, which is critical to signal transmission among cells. Expected to be a new treatment for dementia with Lewy bodies by helping to maintain the concentration of cyclic GMP in the brain.

Dementia with Lewy bodies	Study 201 (DELPHIA)	JP/US/EU	PII/III
Development Code: E2730			In-house
Indications / Drug class: Antiepileptic agent, treatment for neurological diseases / synapse function modulator	Oral

Description: A compound with a novel mechanism of action that selectively regulates the function of activated synapses. Expected to be a new treatment for neurological diseases such as epilepsy, including orphan epilepsy and epileptogenesis.

Epilepsy	Study 201	US	PII
Development Code: E2814		Collaboration		Injection
	(University College London)
Alzheimer's disease	―	US	PI

JP: Japan, US: the United States, EU: Europe, CH: China, P: (Clinical trial) Phase
	◎：Development progress from April 2020 onwards
Reference Data [R&D Pipeline] 18	August 3, 2020 / Eisai Co., Ltd.

◎ Hepatocellular carcinoma/First-line

PIII

LEAP-012

(2) Oncology

Development Code: E7080 Generic Name: lenvatinib Product Name: Lenvima	In-house
Indications / Drug class: Anticancer agent / kinase inhibitor	Oral

Description: An orally administered multiple receptor tyrosine kinase (RTK) inhibitor that selectively inhibits the kinase activities of vascular endothelial growth factor receptors (VEGFR) and fibroblast growth factor receptors (FGFR) in addition to other proangiogenic and oncogenic pathway related RTKs (including the platelet-derived growth factor receptor (PDGFR), KIT and RET) involved in angiogenesis and tumor proliferation. Discovered and developed in-house. Approved for use in the treatment of thyroid cancer in over 65 countries including Japan, the United States and other countries in Europe and in Asia. Also approved in combination with everolimus for use in the treatment of renal cell carcinoma (second-line) in over 55 countries including the United States and other countries in Europe. The agent is marketed under the product name Kisplyx only for this indication in Europe. Approved for use in the treatment of hepatocellular carcinoma (first-line) in over 65 countries including in Japan, the United States, China and other countries in Europe and in Asia. Approved for use in the treatment of endometrial cancer in combination with pembrolizumab in over 5 countries, including the United States. Joint development with Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate.

Monotherapy, joint development with Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate (Additional Indication)

Thyroid cancer	Study 303/308	CH	Submitted (accepted
November, 2019)
◎ Thymic cancer	NCCH1508	JP	Submitted (July, 2020)

In combination with anti-PD-1 antibody pembrolizumab, joint development with Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate (Additional Indication)

Endometrial cancer/Second-line		Study 309	JP/US/EU	PIII
Hepatocellular carcinoma/First-line		LEAP-002	JP/US/EU/	PIII
	CH
Melanoma/First-line		LEAP-003	US/EU/CH	PIII
Nonsquamous non-small cell lung cancer/First-line		LEAP-006	JP/US/EU/	PIII
	CH
Non-small cell lung cancer, PD-L1positive/First-line		LEAP-007	JP/US/EU/	PIII
	CH
Endometrial carcinoma/First-line		LEAP-001	JP/US/EU/	PIII
	CH
Non-small cell lung cancer/Second-line		LEAP-008	JP/US/EU	PIII
Bladder cancer, cisplatin-ineligible/First-line		LEAP-011	JP/US/EU/	PIII
	CH
Head and neck cancer/First-line		LEAP-010	JP/US/EU/	PIII
	CH
◎ Head and neck cancer/Second-line		LEAP-009	US/EU	PII
Selected solid tumors (Endometrial cancer, renal	cell	Study 111	US/EU	PI/II
carcinoma, head and neck cancer, urothelial cancer, non-small
―	JP	PI
cell lung cancer and melanoma)
Melanoma/Second-line		LEAP-004	US/EU	PII

Selected solid tumors (Triple negative breast cancer, ovarian

cancer, gastric cancer, colorectal cancer, glioblastoma and LEAP-005US/EUPII biliary tract cancer)

In combination with anti-PD-1 antibody pembrolizumab and transcatheter arterial chemoembolization, joint development with Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate (Additional Indication)

JP/US/EU/

CH

In combination with anticancer agent everolimus or anti-PD-1 antibody pembrolizumab, joint development with Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate (Additional Indication)

Renal cell carcinoma/First-line

Study 307

JP/US/EU

PIII

JP: Japan, US: the United States, EU: Europe, CH: China, P: (Clinical trial) Phase

◎：Development progress from April 2020 onwards

Reference Data [R&D Pipeline] 19

August 3, 2020 / Eisai Co., Ltd.

In combination with anti-PD-1 antibody nivolumabm, joint development with Ono Pharmaceutical (Additional Indication)

Hepatocellular carcinoma

―

JP

PI

• In July 2020, regarding applications seeking accelerated approval of the combination therapy with pembrolizumab for the first-line treatment of patients with unresectable hepatocellular carcinoma in the United States based on the Study 116 results, a Complete Response Letter (CRL) was received from FDA and therefore were removed from this list.

Development Code: E7389 Generic Name: eribulin Product Name: Halaven	In-house
Indications / Drug class: Anticancer agent / microtubule dynamics inhibitor	Injection

Description: A synthetic analog of halichondrin B derived from the marine sponge Halichondria okadai. Shows an antitumor effect by arresting the cell cycle through inhibition of the growth of microtubules. Approved in over 75 countries including Japan, the United States, China and other countries in Europe and in Asia for use in the treatment of breast cancer. Approved in over 65 countries including Japan, the United States and other countries in Europe and in Asia for use in the treatment of liposarcoma (soft tissue sarcoma in Japan).

Monotherapy (Additional Formulation)

Liposome formulation

―

JP/EU

PI

In combination with anti-PD-1 antibody pembrolizumab, Joint development with Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate (Additional Indication)

Triple negative breast cancer

Study 218

US

PI/II

In combination with anti-PD-1 antibody nivolumab, Joint development with Ono Pharmaceutical (Additional Formulation)

Liposome formulation

Study 120

JP

PI/II

◎The development of the agent in combination with PEGPH20 by Halozyme Therapeutics, Inc. for HER2-negative breast cancer which was in Phase I/II stage in the United States has been finished.

Development Code: E7777 Generic Name: denileukin diftitox (genetic recombinant)

In-house

Indications / Drug class: Anticancer agent / a fusion protein that combines the interleukin-2 receptor binding

domain with diphtheria toxin fragments

Injection

Description: A fusion protein that combines the interleukin-2(IL-2)receptor-binding domain with diphtheria toxins. Specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxins that have entered cells to inhibit protein synthesis.

Peripheral T-cell lymphoma and cutaneous T-cell lymphoma	Study 205	JP	Submitted (March, 2020)
Development Code: E7438 Generic Name: tazemetostat			In-license (Epizyme, Inc.)
Indications / Drug class: Anticancer agent / EZH2 inhibitor			Oral

Description: Believed to have an important role in carcinogenesis, the epigenetic enzyme EZH2 is one of the proteins that constitute the histone methyltransferases. Discovered by Epizyme, Inc. through its proprietary product platform, E7438 is a first-in-class, orally administered small molecule inhibitor, and is expected to exhibit antitumor effects via inhibition of the epigenetic enzyme EZH2. Eisai is responsible for development and commercialization within Japan.

Non-HodgkinB-cell lymphoma	Study 206	JP	◎ Submitted (June, 2020)
Development Code: MORAb-009	Generic Name: amatuximab		In-house
Indications / Drug class: Anticancer agent / chimeric anti-mesothelin monoclonal antibody		Injection

Description: A chimeric IgG1 antibody that targets mesothelin. Expected to show an antitumor effect against cancers that express mesothelin.

Mesothelioma

Study 003/201

US/EU

PI/II

JP: Japan, US: the United States, EU: Europe, CH: China, P: (Clinical trial) Phase

◎：Development progress from April 2020 onwards

Reference Data [R&D Pipeline] 20

August 3, 2020 / Eisai Co., Ltd.

Development Code: H3B-6545	In-house
Indications / Drug class: Anticancer agent / ERα inhibitor	Oral

Description: An orally administered selective estrogen receptor alpha (ERα) covalent antagonist that inhibits ERα wild type / ERα mutant. Expected to show an antitumor effect against ER positive / HER2 negative breast cancers.

Breast cancer	Study 101	US/EU	PI/II
Breast cancer (in combination with CDK4/6 inhibitor	―	US/EU	PI
palbociclib)
Development Code: E7090			In-house
Indications / Drug class: Anticancer agent / FGFR1,2,3 inhibitor			Oral

Description: An orally administered fibroblast growth factor receptors (FGFR1, FGFR2, FGFR3) selective tyrosine kinase inhibitor. Phase II for unresectable cholangiocarcinoma (one of biliary tract cancers) with FGFR2 gene fusion is ongoing. It has been granted the SAKIGAKE designation by Japan's Ministry of Health, Labour and Welfare for the treatment of unresectable biliary tract cancer with FGFR2 gene fusion.

Cholangiocarcinoma	Study 201	JP/CH	PII
Development Code: H3B-6527		In-house		Oral
Hepatocellular carcinoma	―	US/EU	PI
Development Code: H3B-8800		In-house		Oral
Blood cancer	―	US/EU	PI
Development Code: E7386		Collaboration (PRISM BioLab)	Oral
Solid tumors	―	JP/EU	PI
Solid tumors (in combination with lenvatinib)	―	JP	PI
Development Code: MORAb-202		In-house		Injection
Solid tumors	―	JP	PI
◎ Solid tumors	―	US	PI/II
Development Code: E7130		Collaboration (Harvard University)	Injection
Solid tumors	―	JP	PI
Development Code: E7766		In-house		Liquid
Solid tumors	―	US/EU	PI

JP: Japan, US: the United States, EU: Europe, CH: China, P: (Clinical trial) Phase
	◎：Development progress from April 2020 onwards
Reference Data [R&D Pipeline] 21	August 3, 2020 / Eisai Co., Ltd.

(3) Gastrointestinal Disorders

Development Code: AJM300 Generic Name: carotegrast methyl				In-house
Indications / Drug class: Ulcerative colitis treatment / α4 integrin antagonist				Oral
Description: α4 integrin antagonist with a novel mechanism of action believed to suppress adhesion and infiltration of lymphocytes. Aiming to
be marketed as the first orally-available α4 integrin antagonist in the world to be effective in ulcerative colitis. Joint development by EA Pharma
and Kissei Pharmaceutical.
Ulcerative colitis			―	JP	PIII
Development Code: E6007	Generic Name: milategrast				In-house
Indications / Drug class: Ulcerative colitis treatment / integrin activation inhibitor			Oral
Description: A compound with a novel mechanism of action that is believed to suppress the adhesion and infiltration of multiple leukocyte types
by inhibiting integrin activation. EA Pharma aims for commercialization jointly with the University of Tsukuba as an industry-academia practical
application project under the Japan Science and Technology Agency. Development conducted by EA Pharma.
Ulcerative colitis		Study 201	JP	PII
Development Code: E3112				In-house	Injection
Liver disease (Development conducted by EA Pharma)	―	JP	PI
(4) Other
Development Code: E5564	Generic Name: eritoran				In-house
Indications / Drug class: Suppression for increasing of severity of COVID-19/ TLR4 antagonist	Injection

Description: Eritoran is a TLR (Toll-Like Receptor) 4 antagonist created with natural product organic synthesis technology. It is a structural analogue of Lipid A which is an activator of endotoxins of bacteria. It is expected to suppress inflammation and increasing in severity caused by COVID-19 by inhibiting the activation of TLR4, which is found in the most upstream position of various cytokine gene expression signaling that causes the cytokine-storm. Development is in collaboration with GCAR (Global Coalition for Adaptive Research).

◎ Suppression for increasing of severity of COVID-19	REMAP-COVID	US	PIII
Development Code: E6011 Generic Name: quetmolimab			In-house
Indications / Drug class: Crohn's disease / Anti-humanized monoclonal fractalkine antibody		Injection

Description: The world's first humanized anti-fractalkine monoclonal antibody discovered by the Eisai Group subsidiary KAN Research Institute Inc. Expected to exert an anti-inflammatory effect by neutralizing fractalkine. Fractalkine is found in vascular endothelial cells and induces an inflammatory response associated with diseases such as inflammatory bowel disease. Development conducted by EA Pharma.

Crohn's disease	Study ET2	JP/EU	PII
Development Code: E6742		In-house	Oral
Autoimmune disease	―	US	PI

JP: Japan, US: the United States, EU: Europe, CH: China, P: (Clinical trial) Phase

◎：Development progress from April 2020 onwards

Reference Data [R&D Pipeline] 22

August 3, 2020 / Eisai Co., Ltd.