Eisai Value Creation Report 2022
Empowering people to live their lives to the fullest

We will further enhance the hhc (human health care) process that is based on the hhc concept that we have long been implementing. In the hhc process,we obtain an understanding of the anxieties of patients and the people in the daily living domain, and we resolve those anxieties by formulating strategies
for their removal. We will keep ourselves close to the lives of them by enhancing this process. As a result of such efforts, we will aim to evolve the hhc
process to “hhceco,” which is a combination of the hhc concept and an ecosystem that will support people and enable them to “live their fullest life” fromthe time when they are in good health right up to the final moments of their lives, and in doing so we will continuously create value for society.

Eisai Co., Ltd.

Materiality＊1 Value Maximization, Stakeholder Theory, and the Corporate Objective Function (Michael C.

Jensen, 2001)●Eisai’s Materiality Matrix●Process to identify Materiality

Process 2: Prioritization of issues and creation of Materiality Matrix
Process 1: Identification of issues
In identifying issues, we take into account various types of guidelines(e.g., the Sustainability Accounting Standards for Pharmaceuticals
issued by the SASB＊9, and the GRI Guidelines), the Sustainable
Development Goals (SDGs)＊10, the United Nations Global Compact,
communication with stakeholders, and socially responsible investment(SRI) indices (e.g., Dow Jones Sustainability Index)
 ASB (Sustainability Accounting Standards Board) is a U.S.-based＊9 S
non-profit organization that identifies materiality by industry for sensible
investors and develops sustainability disclosure standards.
＊10 The Sustainable Development Goals (SDGs) are a set of international
goals established under the 2030 Agenda for Sustainable Development
adopted at the United Nations Sustainable Development Summit in
September 2015.

We prioritize issues that have a particularly high degree of importance, compare theidentified issues to the corporate concept and mid-term business plan, and createa matrix in terms of “long-term investor interest,” such as financial impact, financial
reporting, opportunities to create innovation, impact of legal regulations andindustry norms, and “ability to create value to society.”

Process 3: Reviews and updates
Close examination is undertaken from various perspectives with reviews byexternal experts, including long-term investors, and the determination on approval
is made by the Chief Investor Relations Officer and the Corporate Officer in chargeof ESG. Reviews and updates are conducted as needed, taking into accountprogress in addressing relevant issues and changes in the business environment.

Contents

Very HighSocial Value Creation(R&D)

and taking into account our corporate concept of“mission and the results,” it can be seen as more efficient
to focus on long-term investors, who are beneficiaries ofresidual income, as the most important stakeholder＊1.
While taking the long-term interests of all stakeholders,
including the people in the daily living domain and our
employees, into account, we believe that identifying theconcerns relating to the interests of long-term investors,
and then implementing related initiatives on a priority
basis, is the fast track to the maximization of corporate
value. The Identified Materiality Matrix and the process to
identify Materiality are shown below.

Management Strategies

Eisai’s corporate concept is to give first thought topatients and the people in the daily living domain.
Likewise, Eisai provides employees, who are responsible
for making a positive contribution to patients, with
opportunities to develop their talents in such a way as toenrich their careers and cultivate work satisfaction. Eisai’s
mission is the enhancement of satisfaction of patients,and of people in the daily living domain. We believe that
fulfilling this mission first will generate revenue andearnings. We attach great importance to this sequenceof placing the mission before the ensuing results.
At the same time, in order to sustainably maximize
corporate value in a way that satisfies all stakeholders

Social value creation

Very HighCorporate foundations
sts

re

High

High

inv

-t

ng

Lo

s

tor

es

erm

te
’ in

Impact on Eisai’s business

Very HighThe color of each materiality number matches the color of the icon for the most applicable SDG.

19

Foundation forsupporting value creation❽❾

Very High

High

High

High

Impact on Eisai’s business

Very HighCorporate Concept❽ Corporate governance system (P.45-52)
Safety management for products＊5❾ Compliance and risk management (P.53-56)
Ethical and transparent drug
creation activities＊6
Protection and reinforcement of intellectual property＊2＊3
Appropriate pricing
Compliance-aware promotion＊7
Financial strategy (P.57-62)
Prevention of bribery and corruption＊7
Supply chain management (P.27-30, 44)
Initiatives against counterfeit drugs＊8
Business that takes human rights into account(P.27-30, 36-40, 44)
Information disclosure＊4
Business that takes the global environment into account (P.41-43)＊2 https://www.eisai.com/company/business/research/ip/index.html＊3 https://www.eisai.com/sustainability/atm/markets/005.html＊4 Article８of the Corporate Governance Principles
https://www.eisai.com/company/governance/cgregulations/cgguideline/index.html＊5 https://www.eisai.com/sustainability/atm/pharmacovigilance.html＊6 https://www.eisai.com/company/business/research/discovery/index.html＊7 https://www.eisai.com/sustainability/management/compliance/index.html＊8 https://www.eisai.com/sustainability/atm/product-security.html

1■ Period Covered
This Value Creation Report covers business performance from April 1, 2021 to March 31, 2022. Some sections may include information on activities
as recent as fiscal 2022.
■ Reporting Organizations
Eisai Co., Ltd. and domestic and overseas consolidated subsidiaries■ Forward-Looking Statements and Risk Factors
Materials and information provided in this Integrated Report 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 materiallyfrom these statements. Moreover, the target values contained in this report merely express medium-term strategies, intended directions and visions andare not an official earnings forecast. For the official earnings forecast, please refer to the annual financial report (Consolidated Financial Statement), whichis compiled in accordance with the rules set by the Tokyo Stock Exchange. Factors that could have a material impact on the future outlook include, but
are not limited to, changes in the economic environment and competitive pressures surrounding Eisai’s business environment, revisions to laws andregulations, fluctuations in currency exchange rates, uncertainties associated with new drug development, and infringements of intellectual property
rights by third parties. Although this report contains information on pharmaceuticals (including those under development), the content is not intended
for advertising or medical advice purposes. In addition, further details about business risks stated above are described in the Annual Security Report.
This English Report was translated from the original Japanese version. In the event of any inconsistency between the statements in the two versions, thestatements in the Japanese version shall prevail.
We maintained proper social distance in interviews and dialogs for this report.
■ Note to Description•Generic names for drugs are given omitting the base or hydrate.
■ Notes to Icons on Each Page
•Pages that are strongly related to the 6 types of capital which comprise Eisai’s corporate value (intellectual capital, human capital, manufactured
capital, social and relationship capital, natural capital and financial capital) are marked with corresponding icons.
•Pages that are strongly related to the 17 Sustainable Development Goals (SDGs) are marked with SDGs icons.
■ Editorial Policy
The “Value Creation Report 2022” is edited to convey Eisai’s sustainable corporate value, including both financial and nonfinancial aspects, to all stakeholders, including shareholders and investors, in an easy-to-understand manner. We refer to theInternational Integrated Reporting Framework published by the International Integrated Reporting Council (IIRC) and the Guidance
for Collaborative Value Creation formulated by Japan’s Ministry of Economy, Trade and Industry.

2

Eisai Value Creation Report 2022

Company Information❶ Creating innovative medicines (P.13-16, 19-26)❷ Offering solutions that go beyond
providing medicines (P.17-18)❸ Stable supply and quality assurance (P.27-30)❹ Strategic partnerships (P.13-18, 19-26)❺ Improving access to medicines (P.31-35)❻ Talent management to support business strategy(P.36-40)❼ Providing a suitable working environment and healthcare
support to assist self-actualization(P.36-40)

23
27
31
36

Progress in Development of Next-Generation Alzheimer’s Disease
Treatments
Progress of Innovative Medicine Creation in the Oncology Area
Stable Supply and Quality Assurance
Improving Access to Medicines
Human Resource Strategies

Foundation forSocial Value Creation

Corporate foundations

Very HighLong-term investors’ interests

High■ Company Information
63 History of Eisai
65 Major Products
67 Global Business Outlook
69 ESG Index/Third-Party Assurance
71 Financial Indicators
72 Status of Shares
73 Corporate Information/Major External Evaluation■ Social Value Creation(Research and Development, Access to Medicine, and Human Capital)

Social Value Creation(Human Capital)

Social value creation

Very High■ Foundation for Social Value Creation
41 Taking the Global Environment into Account in our Business
Activities
44 Taking Human Rights and the Sustainable Procurement into
Account in our Business Activities
45 Corporate Governance
52 Corporate Executives
53 Compliance, Risk Management, and Internal Audit
57 CFO/CIRO Message/Financial Strategy

Social Value Creation(Access to Medicines)

Social value creation ability■ Management Strategies
1 Materiality
3 Corporate Concept: “human health care (hhc)”
5 Value Creation Process and Flow
7 CEO’s Message
11 Eisai’s Value Creation for Society
13 Potential Contribution to People living with Alzheimer’s
Disease and their Families with Lecanemab
15 Efforts to Realize Social Good in the Oncology Area
17 Realizing hhceco (hhc concept + ecosystem)

Foundation forsupporting value creation

Human Capital Corporate Concept: “human health care (hhc)”

and is understood and internalized as our core value by employees globally

Efforts to Realize Innovation Based on the “Knowledge Creation” Theory

The Company’s Corporate Concept is to give first thought to patients and the people in the daily living domain, and to increase the benefits
that health care provides to them. Under this Concept, the Company endeavors to become a human health care (hhc) company.

Business Model based on “hhc”

CSR

CSV

Corporate Social Responsibility

Creating Shared ValueBusiness activities
Results
Revenues, earnings,
etc.

Example of hhc Activities - Job Support at the Naito Museum of Pharmaceutical Science and Industry for a Personwith Younger-onset Dementia (Japan)
hhc

human health care

Value: Doing good

Value: Economic and social
benefits relative to cost

Value: The common good

Citizenship, philanthropy,
sustainability

Joint company and community
value creation

Companies together create value
in tune with community needs

Discretionary or in response toexternal pressure

Integral to competition

No fixation on competition

Separate from profit maximization

Integral to profit maximization

Profits are gained as the result ofstriving for the common good

Agenda is determined by externalreporting and personal preferences

Agenda is company specific andinternally generated

Agenda is shared by each company

Impact is limited by corporate
footprint and CSR budget

Realigns the entire corporate
budgetIncluded in the company’s regular
operating budget

Example: Fair trade purchasing

Example: Transforming procurement
to increase quality and yields

Example: Input of customer
needs into value chain

they can work with peace of mind, and aim to resolve themisunderstanding and prejudice that society demonstrates
toward dementia.

Empathizing with the desire of a person with youngeronset dementia to continue to work after having left his job
due to the condition, Eisai employees proposed an
employment opportunity at the Naito Museum of
Pharmaceutical Science and Industry. The person
concerned actively engages in the maintenance of plants
and trees at the Medicinal Herbal Garden, carrying out
tasks such as weeding, and by finding the work rewarding
and obtaining a sense of accomplishment, demonstrates
enthusiasm for work. His family is also delighted to see thevibrant expression on his face. Going forward, we willcontinue to work closely with the people living withdementia, pursue the creation of an environment where

The person with younger-onset dementia busy
at work＊Compiled by Deloitte Tohmatsu Consulting based on Michael E. Porter, “Creating Shared Value,” Harvard Business Review, and other resources and revised by Eisai.
Supervised by Ikujiro Nonaka, Professor Emeritus of Hitotsubashi University.

34

Eisai Value Creation Report 2022

Company Information

Eisai’s “hhc” is different from
corporate social responsibility(CSR), which mainly involves
social contribution activities
such as acts of charity that do
not directly contribute tobusiness or corporate value. It
is relatively close to Creating
Shared Value (CSV), abusiness model that aims topursue both social value andeconomic value. Eisai’s
mission is to create social
value by enhancing thesatisfaction of patients and theEnhancement ofsatisfaction of patientsand the people in thedaily living domain

describes the background of corporate actions based on
the “hhc” concept, purpose, and results. From theannouncement of the EI concept in 1990 and the “EWAY”
mid-term management plan to the future, the code
describes the steps from the emergence of the “hhc”
concept to its realization, corporate behavior, and theattitude required of those who aspire to achieve results inbusiness. In January 2022, a supplementary edition was
issued, adding information on management based on thecorporate concept, business activities, and what makes
Eisai unique. Employees discuss the contents, deepen
their understanding, and connect it to their work.

COVID-19 causes not only physical disability, but alsomental anxiety, and has deepened prejudice anddiscrimination against some people. The Eisai hhc Codewas issued internally for all employees in the Eisai group
on August 8, 2020, to serve as the basis of all businessactivities and business execution, based on the idea that it
is important to fully consider the value and significance of
empathy, be considerate of other people, and learn tocoexist while being in close proximity to each other in thisunprecedented situation. The code consists of the “MainBook” and the “Supplementary Book.” CEO Haruo Naito
wrote the entire content of the “Main Book,” which

Foundation forSocial Value Creation(2) The Company seeks to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities as a Japaneseinnovation company.
(3) The Company’s mission is to increase the satisfaction of patients and the people in the daily living domain, and to empower them to realize theirfullest life through an hhc ecosystem based on collaboration with other industries. The Company believes that revenues and earnings will be
generated by fulfilling this mission. The Company places great importance on this sequence of placing the mission before the ensuing results.
(4) The Company strives to fulfill its social responsibilities by positioning compliance (i.e., the observance of legal and ethical standards) as the basis of all
business activities.
(5) The Company’s principal stakeholders are patients and the people in the daily living domain, shareholders, and employees. The Company endeavors todevelop and maintain a good relationship with stakeholders and to enhance the value of their stake through: 
1. Satisfying unmet medical needs, raising awareness of illnesses and providing information and services that help prevent them, ensuring a stable supplyof high-quality products, and providing useful information on subjects including drug safety and efficacy;
2. Contributing to a sustainable society with a long-term perspective;
3. Enhancement of the common interests of shareholders and long-term corporate value, a positive return to shareholders and timely disclosure ofcorporate management information; and4. Ensuring stable employment, respecting human rights and diversity, providing full opportunities for growth to support self-fulfillment, and creating an
employee-friendly environment.

Sequence of Mission and
Results Based on the
Corporate Concept hhc
Mission

Permeation of Corporate Concept through “Eisai hhc Code”

Social Value Creation(Human Capital)

Article 2. of Articles of Incorporation (Partially amended in June 2022)

Social Value Creation(Access to Medicines)

the key players outlined above and encourages each
employee to transform themselves with the message “Theworld is changing. Let us change along with it.” The spirit ofthis concept was summarized as “human health care (hhc)”
and incorporated into the company’s Corporate Mission in
1992. In fiscal 2022, the company declared that it would
evolve into an hhceco (hhc concept + ecosystem) company
by adding a digital ecosystem, a platform business, to theoriginal hhc concept. Considering “people who live in the fields
of daily life and medical care” as the key players in realizing thecorporate concept of hhc, we continue to contribute topatients and the people in the daily living domain.

In 1988, when Haruo Naito (currently Representative
Executive Officer and CEO) assumed the position of
President and Representative Director, he identified thechanges in the times, in society, and in people’s attitudes.
Then he began transforming Eisai’s corporate image andchallenging employees to adopt new mindsets and attitudes
as soon as he began his tenure.
In 1990, clearly recognizing patients, their families, and thepeople in the daily living domain as the key players inhealthcare activities, the company announced the concept of“Eisai Innovation (EI)”. This concept advocates taking pride inachieving business results through improving the benefits to

Explicit

Announcement of The Concept of Eisai Innovation in 1990 as the Origin of the Corporate Concept “hhc,”
and Evolution into a hhceco (hhc concept + ecosystem) Company

Social Value Creation(R&D)

and see the situation from their perspectives in order tolearn to empathize with their thoughts and feelings thatthey might not always express in words. Accordingly, allemployees are encouraged to spend at least 1% of
their total business hours interacting with patients(hhc activities).
To share our values and goals with shareholders and tooperate the business more effectively, we incorporated
the corporate concept into the Company’s Articles ofIncorporation, upon receiving approval at the Annual
General Shareholders’ Meeting in June 2005.

Explicit

Amidst the growing need to integrate business activities
with solutions to social issues from the perspectives of theSDGs, purpose-based management, or corporate conceptbased management, Eisai has recognized that patients andthe people in the daily living domain are the main players inhealthcare, and has continued to pursue its corporate
concept of conducting business through increasing theirbenefits for over 30 years.
This corporate concept is summarized by the term“human health care (hhc).” We believe that it is importantfor each employee to first develop proximity to patients

Tacit

Over 500 hhc activities are conducted per year globally

important to repeat this spiral of four phases for strategic
Each Eisai employee aims to realize the corporate concept
knowledge creation. Eisai places particular importance on“hhc” through their daily work by exercising ingenuity basedsocialization in understanding the reality of patients (i.e.,
on Knowledge Creation Theory. There are two types of
emotions), and encourages all employees around the world
knowledge: “tacit knowledge” and “explicit knowledge.” Theto spend at least 1% of their total business hours interacting
former is subjective and not easily expressible, while thewith patients (hhc activities).
latter is expressible. The “SECI model” is the core frameworkof knowledge creation, which creates organizationalinnovation through the repeated andmutual conversion of tacit and explicit
SECI Model Knowledge Creation Spiralknowledge. In this model, knowledge
Tacit
Tacit
creation is captured in 4 phases: (1)Express tacit
Share direct
Socialization(S) Externalization(E)“Socialization (S),” a process ofknowledge
experience andEnvironment
E
O I
building up tacit knowledge throughthrough dialoguebuild up tacitII
and reflection
knowledge
directly sharing experience with others.
I
Individual
Group(Conceptualizing)(Emphasizing)(2) “Externalization (E),” a process ofI
II
expressing tacit knowledge throughdialogue between individuals andInternalization( I ) Combination(C)articulation into concepts orE
Organize
Practice theiconography. (3) “Combination (C),” aGO
relevant concepts
model orG
process for combining explicit
G Org. G
into a prototype,narrative andIknowledge of an organizational level
model, orcreate newEGnarrative
tacit knowledge
into a model, or narrative. (4)(Modeling)(Practicing)“Internalization (I),” a process of
Explicit
Explicit
creating new tacit knowledge throughI = (Individual), G = (Group)O = (Organization), E = (Environment)
practicing explicit knowledge. It is

Tacit

1992,

Management Strategies

Established inis generated as a result. We place great importance on thissequence of placing the mission before the ensuing results.

people in the daily living domain or relieving anxiety overhealth, and economic value in the form of revenue and profit

Value Creation Process and Flowassessment focused on the financial perspective based on the balanced scorecard’s＊2 four perspectives＊3, 4. Thisis also consistent with the thinking (sequence of goals and outcomes) that is based on Eisai’s corporate concept ofcreating social value by enhancing patient satisfaction, our overriding objective, and thereby generating economic
value in the form of sales and profit.

Value generated through corporate activities is built up as “capital,” which is increased, decreased and converted
depending on the business model. In this report, based on the framework＊1 released by the International Integrated
Reporting Council (IIRC), the process of investing capital to engage in business and create added value, wherein theincrease in capital exceeds the inputs, is considered to be the “value creation process.”
Meanwhile, “value creation flow,” or how value is generated through business activities, is ultimately an

This report expresses Eisai’s continuous value generation as a value creation process and flow model based on a
new model that incorporates the IIRC framework and balanced scorecard.

Social Value Creation(R&D)＊1 IIRC, “The International IR Framework,” International Integrated Reporting Council, 2013
＊2 Kaplan, Robert S. and Norton, David P., “Using the Balanced Scorecard as a Strategic Management System,” Boston, MA: Harvard Business Review, January-February, 1996
＊3 Jensen, Michael C., “Value Maximization, Stakeholder Theory, and the Corporate Objective Function,” Business Ethics Quarterly 12 (2), 2002
＊4 Porter, Michael E. and Kramer, Mark R., “Creating Shared Value,” Harvard Business Review, June 2011, pages 8-31

●Eisai’s value creation process and strategy map

Accumulate Capitals for further Value Creation

Eisai’s Strategy Map

Financial Capital• Net DER -0.3ー0.3• Ratio of equity attributable to owners of
the parent 60％ level• Net Debt/EBITDA less than 3 years• Credit rating A level

OutputExpanding long-term shareholder value(P.57-58)

Financial Perspective

Increasing profit(P.59-62)

Increasing revenue• Abundant experience and knowledge of drug
creation activities and pipeline in the Alzheimer’s
disease and oncology areas

OutcomeIncreasing new customers

Human Capital• Human resources permeated with the
hhc concept• Acceptance of diverse values• Hiring and training digital talent

Creation of social value“Relieve anxiety over health”
and “Reduce health disparities”(P.7-18)

Customer Perspective
How should we act to satisfy
patients?

What aspects of the businessmodel should stand out tosatisfy patients andshareholders ?

Creating innovative
products

Providing solutions beyond
pharmaceutical products(P.13-16,19-26)(P.17-18)

Improving accessto medicines (P.31-35)

Strengthening initiatives forpharmaceutical product safety
and to reduce adverse effects＊5

Strengthening compliance andrisk management (P.53-56)• Talents to anticipate change and continuously
create innovation• More active engagement with the company

Manufactured Capital• Stable supply of high-quality products globallyeven in the event of an emergency

Strengthening corporate governance(P.45-52)

Social and Relationship CapitalSocial and Relationship Capital• Execution of partnership strategy• Various initiatives for improving accessto medicines• Expansion of partnership strategy• Contribution to the growth of developing andemerging countries by improving access to
medicines

Innovation andLearning Perspective• Listed “A- ” in CDP (fiscal 2021)• Analysis of financial impact from climate change
on TCFDHow can we sustain the abilityof employees who enable
challenges and improvements torealize the corporate concept?

Natural Capital
Penetrating the concept of human health care (hhc)(P.3-4)＊5,6 Please refer to Eisai’s Corporate Website for more details＊5 Safety Management for Products▶ https://www.eisai.com/sustainability/atm/pharmacovigilance.html＊6 Ethical and Transparent Drug Creation Activities ▶ https://www.eisai.com/company/business/research/discovery/index.html

5• Environmentally responsible business activities• Mitigating climate change risk and creating
opportunities• Achieving carbon neutrality( fiscal 2040 )Encouraging ethics and transparency＊6

Source: C reated by Eisai based on Kazunori Ito and Toshiaki Nishihara, “Disclosure and Usability of Information on Integrated Report of Eisai”, The KAIKEIGAKUKENKYU (The Annual Bulletin of Accounting Study) No.43, 2017 and advice by Professor Kazunori Ito

6

Eisai Value Creation Report 2022

Company Information

Natural Capital

Training and support of global leaders
to take active roles as professionals (P.36-40)

Foundation forSocial Value Creation

Internal Business Perspective

Human Capital
Input

Enhancing customer satisfaction

Manufactured Capital• Stable supply from a global network of
9 manufacturing sites• Contribution to patients by Lecanemab,
an Alzheimer’s disease modifying treatment• Value maximization of anticancer agent
Lenvima®

Social Value Creation(Human Capital)

Intellectual Capital(P.59-62)

Intellectual Capital

Creation of social value “Relieve anxiety over health” and “Reduce health disparities”

How should we act withshareholders to be financiallysuccessful?

Pursuit of Capital Expansion

Figures in parentheses indicate the corresponding pages of this report.

OutcomeFinancial Capital• Net DER -0.32＊• Ratio of equity attributable to owners of
the parent 60.4%＊• Net Debt/EBITDA -2.5 years＊• Credit rating AA- (R&I announced in June 2022)(＊end of fiscal 2021)

Four perspectives based on thebalanced scorecard

Social Value Creation(Access to Medicines)

Six Capitals based on
the IIRC framework

Capitals to Sustain Eisai

Management Strategies

Eisai seeks to increase corporate value by putting its corporate concept into practice. Accordingly,
Eisai considers it a top priority to: work to build relationships of trust with a wide range of stakeholders,
including people in the daily living domain, shareholders, employees and local communities; maximize
value, and strive to be a socially responsible company.

CEO’s Message

Management based on Corporate Concept
Eisai aims to realize social good effectively
Social good

Effectiveness• Relieve anxiety over health• Reduce health disparities• Gather expertise• Capital productivity

Company Information

7

Foundation forSocial Value Creation

We are now in an era where one person develops
dementia every three seconds. By 2030, the numberof people with dementia is expected to reach 78 million
worldwide, and this number is expected to continue
to rise. Being a top runner in solving social issues
in the area of Alzheimer’s disease, we are proud tosay that a major part of this is our knowledge of theanxieties of people with dementia. Over 20 years, morethan 300 hhc projects related to dementia per year
(projects in which all employees spend about 1% of
their total business hours interacting with patients) havebeen carried out globally. And we actually spent time
together with people living with dementia. We havebeen conducting hhc projects to perceive anxieties ofpeople by sharing the same time and space with them.
Through these activities, we have learned that there arethree major anxieties: “When will future risks surface?”,“What should I do to avoid risks?”, and “I don’t want toburden my family.” All of our 10,000 employees havea strong belief that we must work hard to eliminate
these anxieties. This belief has also motivated us andactivities, the delivery is made through various methods
using digital technology to reach those who need it.
For example, dementia-related solutions include
new therapies, information on disease onset
prediction and deterioration based on our data, anddaily cognitive function check apps such as“NouKNOW®”. We believe that these solutions may
result in the improvement of services at each industry
and make a positive contribution for people who
benefit from them. For instance, there are solutions
generated from collaboration with other industries
such as the insurance industry, automobile industry,financial industry, and telecommunications industry,
which include examples like dementia insurance
developed in collaboration with insurance companies,
safe driving for the elderly with automobile
companies, and reducing risk of financial asset
freezes with financial institutions andtelecommunication companies. In addition to people
whom Eisai contributes to through the EUP, we also
aim to expand the business opportunities to include
people whom other industries contribute to throughcollaboration under hhceco.

An hhceco company can also be described as a
People’s Business Company because it serves as an
ecosystem where collaboration of special skills takes
place. The core of this ecosystem is the Eisai Universal
Platform (EUP). The EUP consists involving three layers.
The foundation is research and development, where
medicine creation is enhanced through various
collaborations with academia, startups, and bioventures. The diverse data generated from thesecollaborations make up the second layer. This data is atreasure trove and a source of many solutions, such as
new treatments, and prevention/prediction. Utilizing thisdata, we create solutions for reducing people’s anxieties
and narrowing health disparities, and deliver them
digitally (delivery), which is the third layer called solution
package & delivery. In addition to new therapeutic
agents, EUP’s solutions encompass both the daily living
domain and medical domain, such as information andservices that contribute to prevention of diseases, forexample, a simplified self-check app for cognitive
function and information to predict the onset andseverity of diseases to help “people to live their lives tothe fullest.” Moreover, as well as traditional sales

Social Value Creation(Human Capital)

Relieving Anxiety over Health in the Dementia Area

People’s Business, Including Prevention of Dementia

Social Value Creation(Access to Medicines)

Eisai has been conducting its concept-driven businessunder the corporate concept hhc since 1990. Basedon the hhc concept, the evolution into an hhcecocompany (hhc + ecosystem: hhceco) with a databased ecosystem platform business, was approved at
the general meeting of shareholders in June 2022 andincorporated in the new Articles of Incorporation. We
aim to greatly expand the scope of our contribution
from “patients and their families” to “people in the dailyliving and medical domains.” In other words, we are
evolving into a company which increases the benefits topeople and “supports them to realize their fullest life.”
A modern interpretation of this corporate concept
orients Eisai to “realize social good effectively.” Weregard social good as “relieving anxiety over health”
and “reducing health disparities.” How can we achievethese efficiently? We have a fiduciary duty to develop
business and return profits to shareholders, given that
we are utilizing their important capital. Therefore, ourprinciple is to confirm the productivity of the entrusted

Social Value Creation(R&D)

capital and funds. When we talk about “effectiveness,”
we must think about capital productivity. Furthermore,
the efficiency of achieving goals in business is also
important. In this respect, we believe that bringing
together the strengths of partners, and collaboratingthem to realize a shared purpose, is the most efficientand consistent way to achieve great missions. In
particular, public-private partnerships (PPPs) are an
indispensable approach for realizing social good.
In terms of human resources, we believe that theacquisition, optimal placement and utilization of the besttalents globally is one of the crucial points in operating
our business in a successful and sustainable manner.

Realizing Social Good Effectively o-development with Biogen Inc.
＊1 C
Collaboration agreement on ADUHELM® was amended in March 2022.
＊2 Investigational antibody for Alzheimer’s disease produced as the result of a strategic
research alliance between Eisai and BioArctic. Collaboration with Biogen.

Management Strategies

Obtaining Significant Growth Opportunities
by Realizing Social Good

Accelerated Approval pathway has been completedwith the results of the PhaseⅡstudy, and will be
reviewed by the U.S. authorities by January 6, 2023. In
addition, we aim to simultaneously submit applications
for full approvals within fiscal 2022 in the US, Japanand the EU, based on the results of the Phase Ⅲ study,
which will be obtained in the fall of 2022.

led to innovation in the creation of new medicines andin access to medicines. Eisai has been a pioneer in
opening a new chapter in the treatment of Alzheimer’s
disease. Aricept® was approved in the U.S. in 1996.
ADUHELM® ＊1, an Alzheimer’s disease treatment, wasapproved in 2021, and we expect significant progress inthe development of lecanemab＊2, a disease modifying
treatment candidate for Alzheimer’s disease, in 2022.
Lecanemab, which we have developed, is undergoinga Phase Ⅲ study. Rolling submission based on the

8Eisai Value Creation Report 2022

Relieving Anxiety over Health in Oncology

Realization of a Sustainable Increase in Corporate Value

August 2022
Representative Corporate Officer and CEO

10

Eisai Value Creation Report 2022

Company Information

for us to introduce new technologies and products
to continuously complement the current situation.
Furthermore, as a Japanese innovation company, we
believe that we can take advantage of great potential
in the future for businesses in China, India, and Africa.
Eisai has significant growth opportunities based on its
own capabilities in R&D and digitalization. I would like to
ask for the continued support and understanding of our
stakeholders.

In fiscal 2021, we have achieved a strong capital
structure with equity capital of approximately 750 billion
yen and an equity ratio of 60.4%. We also have net
cash of approximately 240 billion yen, which enables
various growth opportunities.
Lecanemab and its subsequent dementia-related
pipeline, Lenvima® and its subsequent anti-cancer
drug pipeline are expected to have world-class novelty
and usefulness. We believe that our greatest mission
is to make a big leap forward by steadily allocating
resources to these projects. In addition, it is essential
to invest resources in the establishment of EUP and
the development of hhceco, the medium to long term
management themes, that will open up new horizons
for the People’s Business. It is also vitally importantFoundation forSocial Value Creation9

as major stakeholders in the Articles of Incorporation.
We are striving to “ensure stable employment,” “respecthuman rights and diversity,” “enhance opportunities
for employees to develop their skills”, and “create acomfortable work environment.” Furthermore, we
support the United Nations Global Compact, andcontinue to enhance corporate value by addressing theten principles of human rights, labour, environment, andanti-corruption advocated by the United Nations.
We take pride in advancing initiatives in corporate
governance (G). In June 2004, we transitioned to acompany with a nominating committee scheme toensure fairness and transparency in management
and to achieve clear separation of functions between
the oversight of management and the execution ofbusiness. 7 of our 11 directors are independent outside
directors, and the chairperson of the Board of Directors
and the chairpersons of the Nominating Committee,
Audit Committee, Compensation Committee, and hhc
Governance Committee are all outside directors. The
CEO (currently myself) is the only person who serves asboth a corporate officer and a director.

Social Value Creation(Human Capital)

regard the free provision of drugs as a business, and call
Africa is an important region with a total population ofit the “price-zero” business. We have provided over 2
approximately 1.4 billion, and is expected to play anbillion tablets of diethylcarbamazine (DEC) for theimportant role in world economic growth in the future.
treatment of lymphatic filariasis in 29 countries aroundWe are preparing to make our first steps into SADC
the world since 2013. All DEC tablets are manufactured(Southern African Development Community), centering
at our Vizag plant in India. Vizag is an important
on South Africa, and EAC (East African Community),
production site, which contains a manufacturing facility
beginning with Kenya. The expansion into Africa hasfor active pharmaceutical ingredients (APIs), and plays
business purposes, but at the same time, we believe
an important role in efforts to achieve the SDGs. With
that it also supports the realization of the SDGs. There
the adoption of the Kigali Declaration in June 2022, it isare three key points here. The first point is the
expected that the leading role in efforts to eliminate
development of new drugs in Africa, whereapproximately 600 million people are at
Expansion to Africa, Leveraging our Base in India
risk of infection from tropical diseases,
including neglected tropical diseases
Eisai India
EAC(NTDs). We are currently working with
Africa regional lead
(East African Community)
the Global Health Innovative
Population:
200 million
Technology Fund (GHIT Fund), aninternational public-private fund, andMumbai
Kenya
Nairobithe Drugs for Neglected Diseases
Vizag
initiative (DNDi), an international NPO,
Eisai Kenya
SADC
Branch Office(Southern African
to develop new drugs for mycetoma,(Nairobi)
Development Community)
leishmaniasis, lymphatic filariasis,
Population:
360 million
South Africa
malaria and tuberculosis. We are
Johannesburg
aiming to develop new drugs for these
Aim to solve access to
Eisai
South
Africamedicine issues
tropical disease on a full scale locally,
New Company(Johannesburg)and the new office in Kenya will play a
Achieving the SDGs
leading role in this effort. The second
Aim to extend our commitment to relieve anxiety over healthand address health disparities for people in Africa
point is the “price-zero” business. We

Enhancing corporate value over the medium- to longterm by developing ESG initiatives is also important.
Regarding environment (the “E” of ESG) related
initiatives, we issued the “Statement of Commitment
for Carbon Neutrality by 2040” in May 2021 anddeclared that we will accelerate our efforts to protect
the environment more than ever. Going forward, in
addition to continuing with energy-saving initiatives, wewill promote investment in CO2 emissions elimination,
expand the utilization of renewable energy, switch
to low or carbon-free commercial vehicles, actively
introduce advanced technologies, and utilize new fuelssuch as hydrogen.
Regarding initiatives directed toward theenhancement of society (S), our efforts to eliminate
NTDs have progressed over the years, and in the WHO
program, elimination of lymphatic filariasis has beenachieved in 17 of the 72 countries where the diseaseis endemic. The number of people infected with thedisease has decreased by 74% compared to 2000.
In addition, our employees are an important asset inrealizing the corporate concept hhc and are positioned

Social Value Creation(Access to Medicines)

Reducing Health Disparities in Africa and the Tropics

Value Creation for Society through ESG Initiatives

Social Value Creation(R&D)

 ollaboration with PRISM BioLab＊1 C o-development with Bristol Myers Squibb＊2 C

Fycompa® have been launched, our innovative drugs
are awaiting further approvals and launches in othercountries in the SADC and the EAC. We expect that
expanding access to these new drugs will be an
important step toward relieving anxieties over health andreducing health disparities among people in Africa. In
terms of improving access, we would like to consider
new models such as remote medicine (remote diagnosis
and treatment) and internet hospitals, which areexperiencing various remarkable technologicalinnovations.

Management Strategies

E7386＊1, a medium-molecular-weight compounddeveloped in-house, inhibits the protein-protein
interaction of CBP/β-catenin, and is an orally
administered drug candidate that made effective use of
our capabilities in chemistry. Farletuzumab ecteribulin(MORAb-202)＊2, which started a collaboration with
Bristol Myers Squibb in June 2021, is also expected tomake a significant contribution to patients as our firstantibody-drug conjugate (ADC). Farletuzumab
ecteribulin uses Halaven® (eribulin), which embodies thebest of modern organic synthetic chemistry, as a
payload (small molecular-weight drug with antitumor
activity). Halaven® has been contributing to patients withbreast cancer and malignant soft tissue tumors.
Farletuzumab ecteribulin is expected to have best-inclass potential as an ADC targeting folate receptor α.
Through this partnership, we will accelerate thedevelopment of farletuzumab ecteriblin and do ourutmost to deliver it to patients around the world as a
new treatment option.

The contribution that we are making to patients with
Lenvima®, our in-house developed anti-cancer agent,is steadily expanding. Lenvima® is approved for five
types of cancer; three monotherapies and threecombination therapies, including first-line therapy forrenal cell carcinoma and second-line therapy forendometrial cancer in combination with KEYTRUDA®,
which were newly approved in 2021. Its revenue was
192.3 billion yen, up 144% YoY. Adding the lump-sum
sales milestone of 69.2 billion yen received from Merck& Co., Inc., Rahway, NJ, USA, Lenvima®-related
revenue reached 261.5 billion yen. In fiscal 2022, we
expect to obtain data for the acquisition of new
indications such as non-small cell lung cancer in
combination with KEYTRUDA®, which is a steppingstone for the future growth of Lenvima®.
In addition, we aim to help relieve the anxieties ofpatients with cancer by clarifying the mechanism of
resistance to existing cancer immunotherapies andfinding solutions to overcome them through utilization of
the biomarker data that we have collected from the
combination study of Lenvima® and KEYTRUDA®.

tropical diseases will shift to PPP, mainly in endemic
countries. We believe that developing locally based
activities is a new important part of achieving the SDGs.
The third point is that we aim for the smooth introductionof new drugs. It is often argued that people in lowincome countries tend not to fully benefit from cuttingedge drugs and that health disparities exist in thisregard. We consider the introduction of new drugs to be
an important part of achieving the SDGs, and by
focusing on this, we aim to reduce health disparities. In
addition to South Africa, where Lenvima®, Halaven®, andEisai’s Social Value Creation

Relieving people’sanxieties over health

We have expanded the main role of medical care to include not only helping “patients and their families” but also “people in the daily living domain,” and we have
evolved into an hhceco company based on the hhc concept. In the dementia and oncology fields, we will continue to create social value by not only supplying
pharmaceuticals, but also by providing consistent solutions for improving QOL in daily life, disease prevention, treatment, and post-treatment aftercare.

Empowering people to live their lives to the fullest
Social value

Steady progress in initiatives to create value in thedementia area, oncology area, and ecosystem

Patients andtheir families

The people in thedaily living domain

Medicines

Solutions

Major events in and after fiscal 2021

BeyondJune 2021 FDA granted accelerated approval for ADUHELM® (aducanumab) as the first and only Alzheimer’s
disease treatment to address a defining pathology of the disease
June 2021 Eisai and Bristol Myers Squibb entered into global strategic collaboration for Eisai’s antibody drug
conjugate MORAb-202

Major R&D Pipeline
Lecanemab disease modifying treatment for
Alzheimer’s disease

Combination therapy with Lenvima® (lenvatinib) and KEYTRUDA® (pembrolizumab)
approved for patients with advanced endometrial carcinoma

Lenvima® anticancer agent

U.S.: July 2021; Europe: November 2021; Japan: December 2021 (Approved in Japan for patients with unresectable,
advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy)(Expanding indications through LEAP studies)

Combination therapy with Lenvima (lenvatinib) and KEYTRUDA (pembrolizumab)®

®

approved as first-line treatment for adult patients with advanced renal cell carcinoma
U.S.: August 2021; Europe: November 2021; Japan: February 2022 (Approved in Japan for radically unresectable ormetastatic renal cell carcinoma)
March 2022 Acquisition of Arteryex Inc. shares (Arteryex became a subsidiary of Eisai) to strengthen andrapidly expand the foundation of the digital solution business

2022

2020

(MORAb-202), E7386, E7090

Next-generation treatment for Alzheimer’s disease
E2814, E2511

2021

human health care＋ecosystem

July 2022 The U.S. FDA accepted and granted priority review for Eisai’s biologics license application forlecanemab for early Alzheimer’s disease under the accelerated approval pathway

Farletuzumab ecteribulin anticancer agent(hhceco)Dayvigo®
1997

2015

Aricept®

Lenvima®
2012

Pariet®

Dementia
area

Fycompa®
2010

Oncology
area®

Halaven®

(eribulin mesylate) Injection

1941

human health care

(hhc)

Patients andtheir families
Medicines

TimeIvan Cheung
Senior Vice President
Global AD Officer
President, Americas region
Chairman & CEO, Eisai inc.

Simple Dosing:
Treatment with lecanemab does not require titration,and treatment can be initiated with an effective dose. In
addition, we are striving to accelerate development of
the subcutaneous injection formulation for practical use,
aiming to increase convenience for people who receive
lecanemab.

Dosing Regimen to Reduce the Burden on People
who Receive Lecanemab:
We are seeking the potential for reducing dosing
frequency after brain amyloid is cleared by investigating
reduced frequency administration in the open label
extension (OLE) of Study 201. In addition, considerationof subcutaneous injection, that can be administered athome, has also been initiated with selected optimal
dosing based on the results of the PhaseⅠstudy.

With lecanemab, we are opening the door to therealization of social good through precision medicine
based on pathophysiology.

14

Eisai Value Creation Report 2022

Company Information

Simple Monitoring:
Lecanemab demonstrated its safety profile with hightolerability and low incidence of ARIA-E in Study 201.
We are planning to consider reducing the frequency of
MRI scans to examine adverse events, including ARIA-E
in people who receive lecanemab. In the future, we willseek to establish an optimal administration regimen foreach patient by deciding dose frequency/
discontinuation of treatment through blood biomarkers(Aβ42/40 ratio, p-tau and others).

Foundation forSocial Value Creation

13

Preclinical AD:
AHEAD 3-45 is steadily ongoing and enrollment isadvancing in more than 100 medical sites. We aim toestablish an optimal dosing regimen of lecanemab forpeople who are eligible for A45 study, with no or withminor cognitive impairment and elevated levels ofamyloid in brain, or A3 study, targeting cognitively
normal individuals who have an intermediate amount ofamyloid in the brain, and who are at high risk for furtherAβ accumulation, by determining the baseline brain
amyloid level of each subject using PET tracer ([18F]NAV4694) or plasma biomarker (ratio of Aβ 42/40).

Social Value Creation(Human Capital)

Establishing Transparency and Reliability in
Preparation for the Launch of Lecanemab
Preparation for publishing of findings on peer-reviewed
journals is underway, to support potential accelerated
approval of lecanemab. Findings include: clinical study
results, mechanism of action, evidence for pricing, suchas modeling of amyloid-related imaging abnormalities
with edema (ARIA-E) analysis in Study 201, correlation
between biomarker and clinical evaluation items,
consistency of study results, characteristics of thebinding profile of lecanemab, dosing and economicalvalue or cost-effectiveness. We presented the latest
data on lecanemab, such as (1) Correlation between
amyloid reduction and clinical efficacy, (2) Potential of
disease modifying effects, (3) Potential of clinical efficacy
monitoring with plasma biomarker at Clinical Trials on
Alzheimer’s Disease 2021 (CTAD) held in Boston in
November 2021.

Simple Diagnosis:
Since the symptoms in people with early AD are very
mild, it might be difficult to realize an accurate diagnosis.
Digital self-assessment of brain performance that could
be implemented at home, such as CognigramTM andother digital/virtual screening tools, is under preparation
to encourage consultation with specialists, accurate
diagnosis, and early intervention. The key will be thewidespread adoption of less invasive and more familiar
blood biomarker tests in place of PET and cerebrospinal
fluid tests to confirm amyloid positivity for lecanemab.
Through collaboration and cooperation, we aim toachieve diagnosis in clinical practice that is lessburdensome for patients (In December 2021, ourpartner, Sysmex Corporation, has applied to PMDA for
approval to manufacture and market an assay kit tomeasure Aβ in the blood using its HISCLTM automatedimmunoassay system).

Social Value Creation(Access to Medicines)＊ Investigational antibody for Alzheimer’s disease produced as the result of a strategic
research alliance between Eisai and BioArctic. Collaboration with Biogen.

Access / Price Principles for Launch Preparation
We stand with people living with AD and their families,
health care professionals and all of our AD community.
We appreciate the fact that in April 2022, the Centers
for Medicare and Medicaid Services (CMS) has
committed to quickly reconsider the National Coverage
Determination (NCD) once an anti-amyloid drug for thetreatment of AD has met the Coverage with Evidence
Development (CED) requirements with quality evidence.
We believe Clarity AD has a robust design, which
could meet the “high level of evidence” criteria set forth
by CMS in the NCD decision memo if the result is
positive, thereby creating the potential for CMS toreconsider full coverage of lecanemab should it beapproved by the FDA. We look forward to engaging
constructively with CMS to ensure that appropriate
Medicare beneficiaries have access to this potential
new therapy.
We aim to provide value to people with AD and theirfamilies under the corporate concept “hhc”, relieve theanxiety of people living with AD, improve access, andcontinue to create social value, for example by reducing
health disparities. Lecanemab’s socially responsible
pricing aligns ‘value-based pricing’ by improving
patient’s health outcomes, reducing the burden on
caregivers and lowering health care spending, increases
patient affordability by reducing burden of costs, andenhances the sustainability of the healthcare system ineach country. It is important to maintain transparency inprice setting policy and also in terms of the evidence forlecanemab through publication and assessment using
an established and validated disease simulation model
based on the results of Study 201, which predicted thatlecanemab could potentially improve long-term healthoutcome and reduce care costs, resulting in a very
meaningful value-based price range for society, andwhich was published in a peer-reviewed journal. Clarity
AD will provide validation and potentially further
meaningful outcomes.

Seeking a Simple Patient Journey with Lecanemab:
It is important to realize precision medicine based on
pathophysiology to make the patient journey simpler.
We are focusing on the following three aspects, toestablish a simple patient journey with lecanemab.

Early AD:We expect that the results of Clarity AD, such as
efficacy data (clearance of brain amyloid and its clinicalefficacy), safety data (lower incidence rate of ARIA-E),
and effective dosing regimen (no titration and design ofdosing regimen after brain amyloid clearance) would
strongly support the establishment of lecanemab as astandard therapy. We aim to achieve the following
important milestones, to receive approval as an early
AD treatment.
1. P
 rimary endpoint readout is anticipated in Fall
2022 by steadily proceeding Clarity AD
2. O btain FDA’s position on biological license
application (BLA) by the PDUFA date, based on
Accelerated Approval pathway
3. S ubmission of application data to thePharmaceuticals and Medical Devices Agency(PMDA) based on the prior assessment
consultation system
4. Achieve submission for full approvals based on
the results of Clarity AD in Japan, the U.S. and EU
in fiscal 2022

Social Value Creation(R&D)

Development Status of Lecanemab＊ Disease
Modifying Therapy
Eisai has been collaborating on the joint development
and commercialization of lecanemab with Biogen Inc.
Eisai serves as the lead in lecanemab development andregulatory submissions globally, with both companies
co-commercializing and co-promoting the product andEisai having final decision-making authority.
We are smoothly proceeding with activities relating todevelopment and regulatory submissions, andproactively working on expected issues for launch. The
U.S. FDA accepted rolling submission of Biologics
License Application (BLA) for lecanemab as a treatment
for early Alzheimer’s disease (AD) with confirmed amyloid
deposition in the brain based on Accelerated Approvalprogram in July, 2022. The Prescription Drugs User Fee
Act (PDUFA) action date is set for January 6, 2023.
Clarity AD, the Phase Ⅲ study in early AD is ongoingin 1,795 enrolled patients, and the primary endpoint
readout is anticipated in Fall 2022. FDA have agreed toevaluate Clarity AD as a confirmatory study for theclinical efficacy of lecanemab. Based on the results ofthe study, we plan to submit for full approval in Japan,
the U.S., and the EU by the end of fiscal 2022.

Lecanemab as the Standard Therapy for AntiAmyloid Antibody in Combination Therapy:
In the DIAN-TU Tau NexGen study in dominantly
inherited Alzheimer’s disease (DIAD), in patients withgenetic mutation that is almost certain to cause AD
using the investigational E2814 (in-house anti-MTBR tau
antibody), lecanemab has been selected as a standard
therapy for anti-amyloid antibody and combination
therapy with E2814 is under consideration due to its
unique profile.

Management Strategies

Aiming to contribute to people with Alzheimer’s Disease
and Their Families with Lecanemab

Toward Establishing Standard Therapy with
Disease Modifying Therapy of AD with Lecanemab
Lecanemab is a monoclonal antibody that selectively
binds to soluble aggregates, amyloid β (Aβ) protofibrils.
With its unique profile, lecanemab could potentiallybecome a standard therapy in anti-Aβ antibody basedon the results of Study 201 (PhaseⅡb study). Two
Phase Ⅲ studies on lecanemab are ongoing: Clarity AD
in early AD and AHEAD 3-45 in preclinical AD. We are
exploring all possibilities to establish lecanemab as thestandard disease modifying therapy for AD.

Takashi Owa
Senior Vice President
Chief Scientific Officer
Japan and Asia Medical
Safety15●

Early diagnosis
Prediction of risksof recurrence●●

Diagnosis
Understanding
Appropriate treatment the mechanism of resistanceselection
Early detection of recurrence

Aiming to relieve the anxiety of patients with advanced cancer, as well as patients with early-stage,
precancerous and drug-resistant/metastatic cancer

A device that decodes
the base sequence of
ctDNA in blood

Analysis server anddata storage

the efficacy of the combination therapy of Lenvima® and
KEYTRUDA®. Furthermore, by developing anticancer
drugs that can be used in the treatment-resistant phaseand beyond, we aim to contribute to cancer cures,increase survival rates, and improve quality of life (QOL).
In order to produce in-house blood ctDNA
measurement and analysis technology, we have enteredinto a joint research and development agreement with
Personal Genome Diagnostics Inc. (in the U.S.) in fiscal
2019 and started actual measurement and research todetermine the root cause of the disease at the liquidbiopsy laboratory at Tsukuba Research Laboratory infiscal 2021. Through these activities, we aim to relieve
the anxieties of patients with cancer, which we havecome to understand through interaction with them, suchas, “I don’t want to get cancer, I want to be cured. I
want to live a normal life after getting cancer. I want toreceive cancer treatment without feeling anxious.”

developed Halaven® (eribulin), a microtubule dynamics
inhibitor widely used for the treatment of breast cancer
and soft tissue sarcoma. An exclusive global strategic
collaboration agreement was signed in fiscal 2021 with
Bristol Myers Squibb (the U.S.) to develop MORAb-202
for the treatment of multiple types of cancer.
With regard to the investigational drug E7386＊3 (CBP/
β-catenin inhibitor), which is expected to overcome
cancer resistance to Lenvima® and immune checkpoint
inhibitors, we achieved POC (Proof of Concept) as asingle agent in fiscal 2021. In addition to conducting aclinical study of E7386 combination with Lenvima®, wehave newly started a clinical study in combination with
KEYTRUDA®, which was provided free of charge under
the collaboration with Merck & Co., Inc., Rahway, NJ,
USA. Regarding the investigational drug E7090 (FGFR
inhibitor), we will accelerate early clinical studies byutilizing the knowledge gained through the developmentof Lenvima®.
In Cancer Continuum, we aim to develop drugs
that can treat patients from early to late-stage,
potentially leading to a cure and enabling long-term
survival while maintaining daily life, through finding
appropriate collaborative partners.
 o-development with Bristol Myers Squibb＊2 C ollaboration with PRISM BioLab Co., Ltd.
＊3 C

According to a survey＊4 conducted by the National
Cancer Center, one out of every two Japanese people
can be expected to develop cancer. Cancer has thus
become a familiar issue to everyone. The prevalence ofcancer is as high as 65% for men and 50% for women,
but the probability of dying from cancer is relatively low
at 27% for men and 18% for women. On the other
hand, cancers with a low 5-year survival rate, such as
liver cancer, pancreatic cancer, lung cancer, andtreatment-resistant metastatic or malignant cancer,
have high unmet medical needs. By transforming
cancer to a disease that can be cured or a chronic
disease, we aim to relieve the anxieties of patients withcancer and build a society where people can live withcancer without anxiety.

 tDNA: Circulating Tumor DNA＊1 c

Next-Generation Medicine Creation Strategy
for Oncology Utilizing the Experience andKnowledge Gained through the Development of
Halaven® and Lenvima®
We are accelerating the development of next-generation
assets that are in early clinical stages, besides
Lenvima®. Investigational drug farletuzumab ecteribulin(MORAb-202)＊2 is a new antibody-drug conjugate(ADC) which combines farletuzumab, an anti-folate
receptor α antibody, with a payload of in-house ancer Information Service Website: https://ganjoho.jp/public/knowledge/basic/＊4 C
index.html (only available in Japanese)

16

Eisai Value Creation Report 2022

Company Information

Achieving our Mission through the Expansion of
the Indications of the Anticancer Drug Lenvima®
Our mission is to effectively realize social good. We
aim to bring our expertise and technologies together
to create innovative therapeutic agents and provide
them appropriately to patients who can benefit fromthem, in order to effectively relieve the anxieties ofpatients, which is one aspect of social good. We also
promote collaboration with companies that share thesame goal. In the oncology area, we aim to maximize
the value of Lenvima® through a strong collaboration
with Merck & Co., Inc., Rahway, NJ, USA by●

Drug resistant cancer/
metastatic cancer

Foundation forSocial Value Creation

Online lecture by Mr. Suzuki, who has experienced pancreatic cancer
hhc activity of Tsukuba Research Laboratory in fiscal 2021

Prediction ofcarcinogenic risk

Advanced cancer

Social Value Creation(Human Capital)

Mr. Suzuki, Speaker

Medicine Creation Strategy Based on Cancer
Continuum in the Genomic Era
We live in an era in which the nature of each patient’s
cancer is being elucidated at the genomic level. We aim
to relieve the anxieties of not only patients with advanced
cancer but also patients with early-stage cancer,
precancerous conditions, and drug-resistant or
metastatic cancer. Therefore, we believe that early andaccurate diagnosis based on genomic data and theselection and provision of appropriate treatment for eachstage of cancer progression (Cancer Continuum) are key.
Clinical studies of Lenvima are being conductedworldwide, and we expect to collect a huge number ofbiosamples from approximately 10,000 patients overthe next five years. By analyzing the genetic mutationsin these biosamples, we hope to make a greater
contribution to patients. While monitoring the therapeutic
effect of the combination therapy of Lenvima® and
KEYTRUDA®, we will observe changes over time ingene mutations in tumor tissue derived DNA (ctDNA＊1)
in the blood, aiming to elucidate the sustained
therapeutic effect and the treatment resistance at thegenetic and molecular levels. This may lead to theacquisition of digital information that will enable theselection of appropriate therapies that benefit patients.
In addition, the development of next-generation drugs
based on this information is expected to further enhance

Tracking
genetic changes
with ctDNA

Early cancer

Social Value Creation(Access to Medicines)

Taguchi, Researcher
Tsukuba Research Laboratory

conducting clinical studies (LEAP studies) in more than
10 types of cancer for combination therapy with theiranti-PD-1 antibody KEYTRUDA®. In fiscal 2021,
Lenvima® in combination with KEYTRUDA® wasapproved in Japan, the United States and Europe forthe treatment of endometrial carcinoma following priorsystemic therapy (FPST) and as first-line treatment for
unresectable or metastatic renal cell carcinoma.
Furthermore, Lenvima® monotherapy was approved inJapan for the treatment of thymic carcinoma. In fiscal
2022, we aim to obtain data for submission in multiple
types of cancer. Going forward, we aim to maximize
the contribution to patients through the combination ofLenvima® and KEYTRUDA® in the treatment of
immuno-oncology and position Lenvima® as a
backbone therapy in each of multiple types of cancer.

Precancerous condition

Social Value Creation(R&D)

Anxieties of Patients that we Empathize withThrough Socialization (hhc activity)“I was very surprised to discover that I had cancer when
I had a thorough examination due a sudden rise in myblood sugar level. Worried about the progression of thecancer, I decided to have surgery immediately, followedby anticancer drugs treatment. Thanks to the treatment,
I was able to regain a calm life and have a new joy in life,
for example from traveling. However, the physicaldamage due to the surgery was still significant.” This is
the story of a man with pancreatic cancer who gave an
online lecture at the hhc activity held in Tsukuba
Research Laboratory in fiscal 2021. We listened to thispatient’s story, empathized with his anxiety through thestory, and asked about his treatment and medications.
This patient expressed strong requests and expectations
saying, “I want you to develop a drug that has few side
effects and is highly effective.”

Concept of Early Diagnosis/Selection of Appropriate Treatment in Cancer Continuum
CancerContinuumManagement Strategies

Initiatives Aimed toward Realizing Social Good in the Oncology Area
— Aiming to relieve the anxieties of patients with cancer

Keisuke Naito
Vice President
Chief Ecosystem Officer
Head of IT Global HQs

However, this cannot be done alone. We believe thatan ecosystem is essential for creating solutions that
increase people’s wellbeing, to build a platform together
with our partners to efficiently deliver that value, and todeliver the solutions developed on that platform withpartners.
We regard the entire business of providing value topeople as hhceco (hhc concept + ecosystem). We aretransforming into an hhceco company that combines
the hhc concept and the ecosystem to increase
people’s wellbeing and support them in “realizing theirfullest life.”

Evolvin g int o an hhceco Com p any undert he hhc Conce pt………………………………….hhcConcept
Give first thoughts to patients and the people. Strive..tg•••••••••
increase the benefits that health care provides them,and conduct our business to meet their diversified
healthcare needs worldwide.

Add
the people
to patients-C年『 aII/ areas ofprevention,
口 treatment,
and careExample of collaboration with
FCNT LIMITED
Bundling NouKnow® on the
Raku Raku Smartphone

Initiatives on Digitalization as a Core Aspect ofhhcecoWhile the hhc ecosystem is still in its infancy, we intend
to focus on the following initiatives to deliver value andcontribute to people around the world.
•M aintenance of the global IT/digital environment, which
would be the basis of medical + preventative business•D evelop EUP utilizing digital tools•P romote the development of the environment in thearea of dementia to maximize the value of diseasemodifying therapies at the time of launch.

／hhceco com p an y

． ．．．
．

c�

platform
focused on
data

．、

ヽく

20m p叩函

Acquisition of “strengths in software development” and “Personal Health
Record (PHR) products” through consolidation of Arteryex.
App to manage healthcare records:
Click Karte
For more details of “Brain Performance
Exercise,” please refer to the following
Website (only available in Japanese)
https://sodan.e-65.net/maintenance/brain_exercise/17

results of
examination

App to manage healthcare records, such as healthcheck-up, prescription, and results of examination.
Automatic digitization of healthcare record by taking
photos and uploading.

prescription

healthcheck-up

Automatically
digitalized
throughtaking photos

18

Eisai Value Creation Report 2022

Company Information

The basis of this hhceco is the Eisai Universal
Platform (EUP), which was developed throughthe use of external data and collaboration withlocal governments and medical institutions/otherpartner companies, in addition to the know-how,clinical data and other experience that Eisai has
accumulated as a pharmaceutical company. For
example, in March 2020, in the area of dementia,
we began offering “NouKnow®” (pronounced“NOH-NOH”) a digital tool for self-assessment ofbrain performance (brain health), which was jointly
developed with Cogstate Ltd. In addition, a special
exercise program (Brain Performance Exercise) toactivate brain functions has been available since
March 2022 (in Japan only). To develop and provide

Foundation forSocial Value Creation

To strengthen our IT/digital structure as the core of
our entire business, we established the Global IT
Headquarters in April 2022. Our IT strength lies in
two aspects: “Proactive IT” to accelerate business
operations through IT technology, and “Preventative
IT” to pursue operational efficiency and increased

Establish the Eisai Universal Platform IJ n·aer �
the hhcConcept to enable people in the daily
Create an.......l iving and medical domains to achieve theirfor''fullest life''· Create an ecosystem to.se..rY,� ecosystem
collaboration
with a variety
as its core.
of groups a,dSocial Value Creation(Human Capital)

Over 30 years ofefforts since
1992

Initiatives to Promote Development of theEnviroment in the Dementia Area for the
Realization of hhceco
In order to develop the ecosystem, we believe it isimportant to make steady progress in each of theseprojects. First, in the area of dementia, it is important toprovide people with valuable information, since noticing
some symptoms in daily life may lead to early diagnosisof mild cognitive impairment (MCI) and dementia.
Therefore, we are focusing on developing nextgeneration environments, including diagnostics, withthe aim of maximizing the value of disease modifying
treatment at the time of launch.
Furthermore, efforts to develop algorithms forpredicting the course of treatment and visualizationof predicted treatment efficacy using clinical dataand external cohort data could be accelerated if thefoundation for digitalization is in place.
First, we will build an ecosystem in the dementia area,
where we have an advantage, and eventually expand toa global ecosystem. Subsequently, we aim to contributeto the oncology area and other disease areas, and to
expand our business in new platform businesses andlifestyle areas by utilizing accumulated data.

Social Value Creation(Access to Medicines)

We have declared “hhc” as our corporate concept,
aiming to improve people’s wellbeing through ourbusiness activities. Until now, our business activities
have been focused on “patients and their families,” butby redefining our target to “patients and the people inthe daily living domain,” we will be able to truly realize
the “hhc concept.”
In order to improve people’s wellbeing, we aim
to provide consistent solutions not only in medicine
creation, but also in terms of improving QOL in dailyliving, prevention, disease treatment, and posttreatment follow-up through the use of digital tools.

Social Value Creation(R&D)

productivity across our business by providing asecure and stable IT infrastructure. We are globally
implementing business transformation throughdigital tools by balancing both sides of proactive andpreventative IT.
As an example of our efforts to improve theenvironment for digitalization, in March 2022 we
acquired a majority of the shares issued by Arteryex
Inc. (Japan), which is engaged in software planningand development. Leveraging their strength in softwaredevelopment, we will enhance Eisai’s platform todevelop and provide solution packages for healthmaintenance and improvement as well as prevention
and awareness, including digitization of health records
and providing a health management app.

Management Strategies

Realizing hhc eco (hhc concept + ecosystem)

such solutions, collaboration with partners outside
the pharmaceutical industry is essential. We areworking with partners in other industries to provide
solutions for those areas where we have not beenable to provide value to increase people’s benefit.
For example, in collaboration with FCNT LIMITED(Japan), our digital tool “NouKnow®” have been
installed in the “Raku Raku Smartphone F-52B”
developed and manufactured by FCNT LIMITED.

■ Causes of Alzheimer’s disease (AD) and Expectations for New Treatments

Illustration of Treatment Efficacy Expected from Next-Generation Alzheimer’s Disease Treatment

Cognitive function

Mild cognitive
impairment (MCI)

Existing treatments

Mild AD
Moderate AD
Severe AD

Typical progress of ADAge＊ Investigational antibody for Alzheimer’s disease produced as the result of a strategic
research alliance between Eisai and BioArctic. Collaboration with Biogen.

Target of lecanemab■ Development Status of Lecanemab
subjects are African Americans and Hispanic
Americans with early AD. This ratio is similar to theratio of people covered by Medicare in the U.S.
Breakthrough Therapy and Fast Track designations
were granted for lecanemab by the U.S. FDA in Juneand December 2021, respectively. Based on the
Accelerated Approval pathway, rolling submission of
Biological License Application (BLA) for early AD withconfirmed amyloid pathology was initiated in
September 2021, and it was accepted by the U.S.

19

0.0

-0.1

81%
81% amyloid negative per
Visual Read by 18 months-0.2
Placebo
10mg/kg biweekly

-0.3

＊＊＊＊
＊＊＊＊

＊＊＊＊ p<0.0001
0

53

79

0.00
＊

0.05

＊

30%
0.10

＊

0.15

Placebo
10mg/kg biweekly

0.20＊ p<0.05
06

Analysis visit (weeks)

In the Study 201 Core study (18-monthadministration), the reduction of Aβ in the brain (Fig.
1) and the effect of suppressing the deterioration ofclinical symptoms (Fig. 2) were confirmed by theadministration of lecanemab. Based on a preset
analytical method, the highest dose of lecanemab(10 mg/kg biweekly) showed consistent progression
inhibition at endpoints for assessing multiple clinicalmanifestations as well as biomarker indicators(AlzRes Therapy 13; 21).
After the Study 201 Core study, the Study 201
OLE study, in which all subjects were administeredlecanemab, was started after a gap period (24months on average) in which lecanemab was not
administered. When the subject’s intracerebral Aβ
accumulation was confirmed at the start of theStudy 201 OLE study, intracerebral Aβ remained
low in the group which lecanemab was administeredin the Study 201 Core study, even during the gap
period from the end of administration to the start of
the Study 201 OLE study. In addition, the difference
between the placebo group and the lecanemabadministered group observed in the Study 201 Core
study was maintained regarding the exacerbation ofclinical symptoms, suggesting the possibility of the

12

18

Analysis visit (months)

disease-modifying effect of lecanemab. Moreover,intracerebral Aβ in subjects receiving placebo in the
Study 201 Core study declined rapidly after starting
lecanemab 10 mg/kg biweekly in the Study 201
OLE study, with a reduction of more than 40% at 3
months and more than 80% at 12 months achieved
amyloid negative status by the interpretation ofamyloid positron emission tomography (PET)
images. In the Study 201 Core study, a reduction of
Aβ in the brain was also observed in the subjects
who received lecanemab (Fig. 3).
●Figure 3. Changes in brain Aβ in Study 201 Core and OLE
studies
0.2

Study 201 Core

0.1

Gap Period(24 months on average):
Off Lecanemab

Study 201 OLE

1.31

0.0

0.05

0.03

1.29

-0.1

1.36

-0.2

-0.23

-0.27

-0.26

-0.3

-0.35

-0.4

-0.32

-0.34

-0.38

-0.5
Core Baseline

18m

Visit

OLE Baseline OLE 6m
OLE 3m
OLE 12m

Percentage of Amyloid Negative based on PET SUVr
Placebo(10)(10) 10%(10) 10% (3) (7)(8) 88%10mg/kg monthly (19)(19) 63%(19) 47% (12) (7)(11) 64%

10mg/kg biweekly (10)(10) 90%(10) 80% (4) (6)(7) 86%Amyloid negative defined as SUVr < 1.17 using florbetapir as imaging tracer
Numbers shown in parentheses are the number of subjects who had PET examination

20

Eisai Value Creation Report 2022

Company Information

In a Phase Ⅱb study (Study 201) in early AD,
lecanemab demonstrated slowing of diseaseprogression in addition to dose-dependent reductionof brain Aβ. Based on these results, single Phase Ⅲ
study (Clarity AD) in early AD is ongoing following
discussion with the regulatory authorities, andenrollment of 1,795 subjects has been completed.
Primary endpoint readout is anticipated in Fall 2022.
Subjects for Clarity AD were recruited with racial
diversity; especially in the U.S., approximately 25% of●Figure 2. Effect of suppressing the deterioration of clinicalsymptom with lecanemab administration (ADCOMS)

Foundation forSocial Value Creation

Lecanemab is an anti-Aβ protofibril antibody produced
through collaborative research with BioArctic AB(Sweden). In a brain affected by AD, multiple Aβ
aggregates exist in complex equilibrium, including
dimers, oligomers, protofibrils, and insoluble fibrils.
Soluble aggregates such as protofibrils are thought to
be toxic to neurons. Lecanemab is a humanizedantibody generated using protofibrils engineered fromAβ harboring genetic mutations that cause familial AD.

●Figure 1. Reduction of brain Aβ with lecanemab
administration (PET SUVr)

Social Value Creation(Human Capital)■ Origin and Mechanism of Action of Investigational Anti-Aβ Protofibril Antibody Lecanemab＊

Lecanemab Study 201 Core study – Open Label Extension (OLE) study

Social Value Creation(Access to Medicines)

Next-generation Alzheimer’s disease (AD) treatment

for next-generation AD treatments is based.
Development of next-generation dementia treatments
based on the Aβ hypothesis targets early AD (mildcognitive impairment [MCI] due to AD and mild AD)
where Aβ accumulation in the brain is observed, andpreclinical AD, where earlier cognitive impairment has
not been confirmed.
Regarding dementia drugs, symptomatic treatments,
including in-house developed Aricept®, have over 20
years of history in the market, and their efficacy andsafety have been well established. However, theworsening of cognitive function is inevitable after acertain period of administration, as indicated by the blueline in the figure on the left, and these treatments cannot
be expected to have the effect of stopping the
progression of the disease. Therefore, next-generation
AD treatments, which could delay the onset ofdementia, or suppress the decline of cognitive function
for a long period of time (indicated by the red line in the
figure on the left), are desirable.

Social Value Creation(R&D)

In AD, which accounts for more than 50% of dementia
cases, peptides called amyloid beta (Aβ) aggregate andaccumulate in the brain 10 to 20 years before
symptoms appear. It is believed that the aggregation
and accumulation of Aβ in the brain triggers theformation of tau protein that resides in neurons andaccumulates in the cells, leading to neuronal cell death.
This is the Aβ hypothesis, upon which Eisai’s research

Adjusted Mean Change from Baseline (±SE)

Expanding our contribution in the Alzheimer’s disease area with the launch of
new treatments and an extensive pipeline

Predicted PET SUVR change from Core baseline (+/-SE)

Estimated number of people with dementia worldwide as of 2030, including Alzheimer’s disease

formulation, based on data obtained from previous
clinical trials, we expect to have similar bloodconcentration, amyloid removal effect and low incidenceof amyloid-related imaging abnormalities edema(ARIA-E) as with intravenous administration. In addition
to the subcutaneous injection formulation, we areconsidering looking into the development of an autoinjector to provide a more convenient method ofadministration, which would allow people who receive
lecanemab, or caregivers, to administer the drug at
home. From Study 201 data, new findings wereobtained for less frequent maintenance treatment toprevent re-accumulation after the brain Aβ was reduced
to a sufficient level.

Management Strategies

78 million

FDA in July 2022. The Prescription Drugs User Fee
Act (PDUFA) action date has been set for January 6,
2023. After the potential BLA approval under theaccelerated approval pathway, submission for full
approval based on a confirmatory study of Clarity AD isplanned in the U.S. in fiscal 2022. In Japan, submissionof application data to the Pharmaceuticals and Medical
Devices Agency (PMDA) has been initiated in March2022 under the prior assessment consultation systemaiming at shortening the period for review. Application
for manufacturing and marketing approval is anticipatedin fiscal 2022, based on the results of Clarity AD, andsubmission is also anticipated in fiscal 2022 in the EU.
Regarding the investigational subcutaneous injection

Adjusted Mean Change from Baseline (±SE)

Intellectual Capital Progress in Development of Next-Generation Alzheimer’s Disease Treatments

●Figure 5. Decrease in plasma p-Tau181 with administrationof lecanemab

Study 201 Core

Follow up

Gap Period

Study 201 Core

0.08750.09000.0925△～47％

0.095001218Visit (months)
32

32

30

10mg/kg biweekly 25
23
24
Numbers shown at the bottom of the figure are the number of subjects

Mean C values (±SE)
in Plasma p-Tau181 (pg/mL)

Reduction in accumulated AβMean C values (±SE)
in Plasma Aβ42/40 Ratio

0.0850

Placebo

Follow up

Gap Period

5

5

4

△～24％

3

2

OLE Baseline

0

12

18

OLE Baseline

Visit (months)

32

Placebo

25

39

34

35

10mg/kg biweekly 30
2630
Numbers shown at the bottom of the figure are the number of subjects

27
20

select lecanemab as the standard for anti-Aβ therapy
in response to increasing evidence of AD-related
biomarker decline in November 2021, and the firstsubject was enrolled in January 2022. Symptomatic
individuals are randomly assigned to receive additional
E2814 or placebo after 6 months of lecanemab
treatment. Asymptomatic individuals are randomly
assigned to receive the anti-tau drug or a placebo fora year before beginning lecanemab administration. If
the primary and secondary endpoints are positive in
the analysis two years after the start of study, thestudy will be extended for another two years.
E2814
Essential for spreading of tau

MTBR

Tau protein

NC

R1 R2 R3 R4
1441

Intracellularaggregates

N-terminal tau fragment
Intracellular without the aggregate-prone
aggregates
MTBR region may

Cleavagenot spread tau pathology

E2814
E2814 binds to
MTBR tau and inhibits tau
seed formation and spreading

Full length tau protein
N-terminal tau fragment
MTBR-tau fragment

Monotherapy
periodSymptomaticcohortlecanemab

E2814-bound tau seeds are removedby microglia, preventing the expansionof tau accumulation in the brain
and suppressing disease progression

Randomized period
E2814 + lecanemab
Placebo + lecanemab

6 months

3.5 years

Beginning of dosage

Interim analysis (2 years from the beginning)

Randomized period
AsymptomaticcohortE2814

Social Value Creation(Human Capital)

Reduction in accumulated Aβ

0.0825

Tau was discovered as a microtubule-associatedprotein, and is known as an important molecule
involved in stabilizing microtubules in nerve cell axons,
regulating axonal transport and signal transduction,and brain maturation. Tau is the main constituent ofneurofibrils, which is one of the pathological changes
in AD, and it is known that the spread of neurofibrils
and the severity of cognitive dysfunction in AD are
well correlated.
E2814 is an anti-MTBR (Microtubule binding
region) tau antibody created in collaboration with
University College London (UK). E2814 targets tau
seeds, which are known to propagate to different
parts of the brain and cause tau lesions as thedisease progresses, preventing further expansion ofneurofibrils in the brain, which may result insuppression of the progression of the disease. An
increase in MTBR tau has been confirmed in the AD
brain, and we believe that E2814 recognizes anappropriate target.
Many people with a genetic mutation that is almost
certain to develop AD (dominantly inherited
Alzheimer’s disease: DIAD) tend to develop symptoms
at about the same age as the affected parent. E2814
was selected as the first anti-tau drug to be evaluatedin the TauNexGen study (Phase Ⅱ/Ⅲ study) conductedby the Dominantly Inherited Alzheimer Network Trials
Unit (DIAN-TU) for DIAD. This study aims to evaluate
the safety, tolerability, biomarkers and cognitiveeffects of E2814 in symptomatic and asymptomatic
people with DIAD. Furthermore, in clinical studies
aimed at Aβ-targeted therapy, it was decided toSocial Value Creation(Access to Medicines)●Figure 4. Increase in plasma Aβ42/40 ratio withadministration of lecanemab■ Investigational Anti-MTBR Tau Antibody E2814

Social Value Creation(R&D)

previous case with convulsions in the Core and
OLE studies receiving 10 mg/kg biweekly.
Currently, the accumulation of Aβ in the brain in
the diagnosis of AD is confirmed by PET and
cerebrospinal fluid testing, but as a less invasive
examination method, it is strongly suggested that
Aβ pathology in the brain can be understood bymeasuring plasma Aβ42/40 ratio and plasma
p-Tau181. It was also found that the increase in theplasma Aβ42/40 ratio (figure 4) and the decrease inplasma p-Tau181 (figure 5) correlate with changes
in Clinical Dementia Rating Scale Sum of Boxes(CDR-SB). The plasma Aβ42/40 ratio and plasma
p-Tau181 are plasma biomarkers showing
continuous changes with the progression of AD.
Plasma biomarkers are increasing the possibility ofunderstanding the state of the brain as a minimallyinvasive testing method.

Management Strategies

ARIA is an important adverse event observed in
Aβ-targeted therapies, and it is important for this tobe monitored and managed during treatment. The
incidence of ARIA-E in the 10 mg/kg biweekly
group in the Study 201 Core study was 9.9%
compared to 0.8% in the placebo group. ARIA-E is
known to occur more frequently in ApoE4 carriers,
and a similar trend was confirmed in the Study 201
Core study (14.3%). Most ARIA-E occurred within 3months of treatment in the Study 201 Core and
OLE studies, and in many cases it disappeared
within 4 months of detection. The majority of casesof ARIA-E were reported to be mild or moderate inseverity, based on imaging, with 1.2% being
severe. The majority of ARIA-E cases wereasymptomatic, and symptomatic ARIA-E wasreported in 1.9% of cases. Symptoms associatedwith ARIA-E included headache, visual impairment,
confusion, aphasia and others, including one

E2814 + lecanemab

Placebo

Placebo + lecanemab
1 year

Beginning of dosage

3 years
Interim analysis (2 years from the beginning)■ Investigational TrkA-binding Synapse Regenerating Agent E2511
lecanemab for 216 weeks. The A45 trial aims toevaluate the suppression of cognitive decline and the
suppression of progression of AD pathology in thebrain by administration of lecanemab to those whohave no cognitive impairment and who are positive forAβ accumulation in the brain. The A3 trial is designed
for people with no cognitive impairment, who havebrain Aβ in the earlier borderline region, and are at highrisk of further increases in brain Aβ accumulation.

small molecule compound E2511 binds to TrkA, andis expected to activate cholinergic nerve survival andsynaptic regeneration signals. It may also promote
recovery of damaged nerves, synaptic remodeling,
and neural network remodeling. E2511 is currently inPhaseⅠstudy.
Cell body
Upregulation of cholinergic
functional genes
Nucleus

Pre-synapse

Axonal growth↑
Neuronal survival↑
Synaptic function↑
NGF

Post-synapse

E2511 TrkA
：Cholinergic functional molecules

advance the developmental progress of lecanemab
with the aim of maximizing its value, realizing social
good, and eliminating the anxieties of people andtheir families.

In March 2022, Biogen Inc. (the U.S.) and Eisai
amended their collaboration agreement to maximize
the value of aducanumab (product name in the U.S.:
ADUHELM®＊) and lecanemab, aiming to increase
operational efficiency and enabling more focused
execution. We are ready to make every effort to o-development with Biogen Inc. Collaboration agreement was amended in March
＊C
2022.

21

22

Eisai Value Creation Report 2022

Company Information■ Regarding the Amendment of the Collaboration Agreement with Biogen Inc.

We are also working on a project to regenerate
synapses that form networks between nerve cells andrestore synaptic dysfunction.
Cholinergic neurons are vulnerable in the brain ofpeople with AD. Tropomyosin receptor kinase A (TrkA)
is a cell membrane receptor for nerve growth factor(NGF) and contributes to the survival and maintenanceof acetylcholinergic neurons.
Decreased expression of TrkA is observed in mild
cognitive impairment due to AD, but it has not led tomarked neuronal loss. Eisai’s in-house developed

Foundation forSocial Value Creation

The Phase Ⅲ study, AHEAD 3-45, is targeted at
preclinical AD, which is an earlier stage in the AD
continuum, and this study is being conducted througha public-private collaboration between the Alzheimer’s
Clinical Trials Consortium (ACTC, the U.S.) and Eisai.
This Phase Ⅲ study is placebo-controlled, doubleblind, parallel-group comparison study, in which
participants are enrolled in one of two trials (A45 andA3), based on brain Aβ accumulation, and receiveIntellectual Capital Progress of Medicine Creation in the Oncology Area

(Revenue target of Lenvima® for fiscal 2025)

Progress toward expansion of Lenvima® revenue and development of
post-Lenvima® product●Revenue of Lenvima®

 envima : Expansion of Contribution to■L
Patients Worldwide®

■Americas■China■EMEA■Japan■Asia/Latin America

192.3B JPY
144% YoY

133.9B JPY
120% YoY

218.0B JPY
113% YoY

Indications
approved before fiscal 2020

145.5

116.5

Hepatocellular carcinoma 1L

Fiscal 2020 results

26.5

Approved in more than 80 countries

21.8
10.3

23.5
13.5

Thymic carcinoma

8.8

Fiscal 2021 results

9.0

Renal cell carcinoma 2L
Approved in more than 65 countries●Milestone payments received as of August 5, 2022

Clinical and regulatory milestones payments(Received maximum amount of payment
set at the time of agreement)

Sales-based milestone payments(1,350 million USD received)

300 million USD

50 million USD
150 million USD
150 million USD
200 million USD
200 million USD

Approved in more than 40 countries

Non-squamous cell carcinoma
Combination with chemotherapy

Endometrial carcinoma FPST

Endometrial carcinoma FPSTApproved based on the results ofStudy 309 (Phase Ⅲ)
Approved in more than 45 countries,
including approvals based on the results of Study 111

Approved based on the results ofStudy 111 (Phase Ⅰ/Ⅱ)

Non-small cell lung cancer 2L

Head and neck cancer 1L

Head and neck cancer 2L

Hepatocellular carcinoma 1L

Esophageal carcinoma 1L

Combination with TACE

Gastric cancer 1L
Combination with chemotherapy

Combination with chemotherapy

Colorectal cancer 3L

Basket trial in multiple cancer types（Gastric cancer, colorectal cancer, glioblastoma, biliary tract cancer, and pancreatic cancer）

Approved in more than 45 countries,
including approvals based on the results of Study 309

Blue: Monotherapy
Purple: Combination with everolimus
Green: Combination with KEYTRUDA®

1L: First-line 2L: Second-line 3L: Third-line

3. Approval of the combination therapy of Lenvima® and KEYTRUDA® in renal cell carcinoma and endometrial carcinoma
regimen in any setting regardless of treatment
The Phase Ⅲ study of Lenvima® and KEYTRUDA®
line, Lenvima® in combination with KEYTRUDA®
combination in first-line therapy for patients withadvanced renal cell carcinoma demonstrated
demonstrated statistically significant improvements instatistically significant improvements in the primary
the primary endpoint of PFS as well as OS, and in theendpoint of progression-free survival (PFS), and insecondary endpoints of ORR versus
the key secondary endpoints of overall survival (OS) andchemotherapy (investigator’s choice of doxorubicin or
objective response rate (ORR) versus sunitinib. Basedpaclitaxel). Based on the results of the study, advancedon the study results, the advanced renal cell carcinoma
endometrial carcinoma following prior systemic therapy
indication was approved in Japan, the United States,(FPST)＊ has been approved in Japan, the Unitedand Europe.
States, and Europe.
In the Phase Ⅲ study in patients with advanced＊ Indication in the U.S. is advanced endometrial carcinoma that is not microsatellite
instability-high (MSI-H) or mismatch repair deficient (dMMR) and progressed following
endometrial carcinoma who had previously been treatedprior systemic therapy in any setting in patients who are not candidates for curative
surgery or radiation.
with at least one prior platinum-based chemotherapy

Company Information

300 million USD
300 million USD

450 million USD was received in fiscal 2017 as a reimbursement for R&D expenses

23

Foundation forSocial Value Creation

Approval of hepatocellular carcinoma
Achievement of revenue ofindication in Japan
25 million USD
500 million USD(Fiscal 2017)
in fiscal 2018
Approval of hepatocellular carcinoma
Achievement of revenue of
One-time option payment
325 million USD
indication in the U.S.
125 million USD
800 million USD from(Fiscal 2018)(Fiscal 2018)
January to December 2019
Approval of hepatocellular carcinoma
Achievement of revenue of
One-time option payment
200 million USD
indication in Europe
50 million USD
750 million USD(Fiscal 2019)(Fiscal 2018)
in fiscal 2019
Achievement of revenue ofApproval of reimbursement for hepatocellular
One-time option payment
25 million USD
1,000 million USD
125 million USD
carcinoma indication in Europe(Fiscal 2020)
in fiscal 2019
(Fiscal 2018)
Approval of hepatocellular carcinoma
Achievement of revenue ofindication in China
25 million USD
1,200 million USD from(Fiscal 2018)
January to December 2020
Approval of thyroid cancer
10 million USD
Achievement of revenue ofindication in China(Reversal of R&D
1,400 million USD fromJanuary to December 2021
(Fiscal 2020)
expenses)
Approval of renal cell carcinoma
75 million USD
Achievement of revenue ofindication in the U.S.
(Reversal of R&D
1,500 million USD(Fiscal 2021)
expenses)in fiscal 2021
Approval of renal cell carcinoma
25 million USD
indication in Japan(Reversal of R&D(Fiscal 2021)
expenses)
Approval and reimbursement for renal cell
25 million USD
carcinoma indication in Europe(Reversal of R&D(Fiscal 2022)
expenses)
Total 2,685 million USD (of which 135 million USD was recognized as reversal of R&D expenses)
Up-front payment(Fiscal 2017)

Non-small cell lung cancer 1L

Social Value Creation(Human Capital)

Maximum of up to 5,760 million USD in total (approx. 611.0 billion JPY )▶ One-time payments: 950 million USD (approx. 101.0 billion JPY)
・Upfront payment: 300 million USD (approx. 32.0 billion JPY)
・One-time option payments associated with Merck & Co., Inc., Rahway, NJ, USA exercising certain option rights: 650 million USD (approx. 69.0
billion JPY)
▶ Reimbursement for R&D expenses: 450 million USD (approx. 48.0 billion JPY)
The deposits were withdrawn as Eisai’s share of the R&D expenses on Lenvima®, then booked as the reversal of R&D expenses.
▶ Milestone payments: Maximum of up to 4,360 million USD in total (approx. 462.0 billion JPY)
・Clinical and regulatory milestones: Up to 385 million USD (approx. 41.0 billion JPY)
Regulatory approval of indications in hepatocellular carcinoma or renal cell carcinoma, etc.
®
・Milestones associated with sales of Lenvima : Maximum of up to 3,970 million USD (approx. 421.0 billion JPY)
＊1 USD=106 JPY (Exchange rate at the time of contract conclusion)

Melanoma 2L

Renal cell carcinoma 1L

Approved in Japan

Fiscal 2022 forecast＊

Melanoma 1L

Social Value Creation(Access to Medicines)

6.5

35.0

Studies for indication expansion
in combination with KEYTRUDA ®
Endometrial carcinoma 1L

Approved in more than 80 countries●Financial terms of the strategic agreement with Merck & Co., Inc., Rahway, NJ, USA

One-time payments(Received maximum amount of payment
set at the time of agreement)

Indications
approved in fiscal 2021

Thyroid cancer 1L

81.0
18.5
15.8
12.2

®
®
●Approved indications for Lenvima and further expansion of indications in combination with KEYTRUDA as of August 5, 2022

Social Value Creation(R&D)

1. Steady progress on collaboration and expansion of revenue
Eisai and Merck & Co., Inc., Rahway, NJ, USA agreed
to a global strategic collaboration for Lenvima® in March2018. Co-commercialization of Lenvima® is currently
ongoing in over 20 countries as of March 2022. With
Lenvima®’s revenue forecast for fiscal 2022 set at 218
billion JPY, Lenvima®’s revenue is steadily expanding
toward target revenue of 500 billion JPY level in fiscal
2025.
Eisai has received a total of 2,685 million USD from
Merck & Co., Inc., Rahway, NJ, USA as upfront, onetime option, milestone payments and reimbursement for
R&D expenses as of August 2022 since thiscollaboration was initiated.

(Billions of yen)Management Strategies

500 billion JPY level

2. Clinical studies aimed at expanding indications are progressing steadily
data for new indications such as non-small cell lung
Clinical studies, including pivotal studies for combination®
®
cancer in combination with KEYTRUDA®, which istherapies of Lenvima and KEYTRUDA , are ongoing in
more than 10 types of cancer. In addition to 13 studies
essential for future growth of LENVIMA®, is anticipated.
that were originally planned at the time of the strategic
By obtaining indications in multiple types of cancer, weagreement with Merck & Co., Inc., Rahway, NJ, USA,aim to position this combination as a core therapy in
new studies aimed at further expansion of indication,
cancer treatment.
such as hepatocellular carcinoma in combination＊1 Transcatheter Arterial Chemoembolization (TACE): A therapy that selectively
with TACE＊1, gastric cancer, colorectal cancer, andobstructs blood circulation to induce necrosis in hepatocellular carcinoma by
injecting embolization material into the hepatic artery that supplies nutrient blood toesophageal carcinoma, are underway. In fiscal 2022,
the tumor

24

Eisai Value Creation Report 2022

PD-L1■The mechanism of tumor associated macrophages
Anti-PD-1 antibody

PD-1

Cancer Weakened
attackcells

Cytotoxic
T cells

To protect themselves, cancer cells inhibit the action ofcytotoxic T cells attacking cancer cells through the binding
between PD-1 and PD-L1■The work of anti-PD-1 antibody
Anti-PD-1 antibody

PD-L1

Inhibits
Weakened
Cytotoxic action
attack
T cells
Tumor associated macrophages are cells that cancer cells activate
to protect themselves and inhibit the attack of cytotoxic T cells
Cancercells■The mechanism of Lenvima®
Anti-PD-1 antibody

PD-1

PD-L1

PD-1

Tumor associatedmacrophages

Tumor associatedmacrophages

Inhibits
actionAttackmore strongly

AttackCytotoxic
T cells

Cancercells

The anti-PD-1 antibody releases the brake on the cytotoxic
T cells by inhibiting the binding between PD-1and PD-L1,
which results in attacking the cancer cells

Cytotoxic
T cells

Lenvima®

Lenvima® activates cytotoxic T cells by inhibiting the action oftumor associated macrophages, which results in attacking thecancer cells more strongly

 edicine Creation Strategy Based on Cancer Evolution in Progression of Cancer (Cancer■M
Continuum)(a biological test using blood samples), finding
the appropriate target for medicine creation, andproviding patients with appropriate cancer treatments,
leading to precision medicine.
In January 2020, Eisai entered into a joint researchand development agreement with Personal Genome
Diagnostics Inc. (the U.S.) for a cancer genetics panel
test. In this joint research and development project,●Medicine creation strategy based on progression of cancer (Cancer Continuum) and gene mutation

Ultra-early cancer

Gene mutation associated with canceration/proliferation/infiltration

Advanced cancer

Drug-resistant cancer

Gene mutation associated with recurrence/metastasis/treatment resistanceInduction of neoantigen (Splicing modulator)

Enhance response to tumor immunity

Modulation of Wnt/β-catenin signaling pathway (E7386)

Targeting cell population that has initial gene mutation in canceration
FGFR inhibitors (E7090)

Targeting FGFR-dependent cancers

Proteolysis Targeting Chimeras (PROTACs) (Protein Degrader)

Targeting cancer microenvironment that is immunosuppressive

Tumor vessel remodeling, tumor stroma improvement(Farletuzumab ecteribulin, liposomal formulation of eribulin, and E7130)

ERα inhibitor targeting existing-therapy-resistanceby covalent inhibition

ERα inhibitors (H3B-6545)

Establish as standard of therapy
by leveraging immunomodulatory activity of Lenvima®

VEGFR and FGFR dual inhibitor Lenvima® and KEYTRUDA®

 o-development with PRISM BioLab Co., Ltd.
＊C

In-house developed novel FGFR inhibitor tasurgratinib (investigational E7090)
Discovered in-house at Tsukuba Research
selectivity for FGFR.
Laboratories, tasurgratinib is an orally available novel
A Phase Ⅱ study is ongoing in patients withtyrosine kinase inhibitor that demonstrates selective
cholangiocarcinoma harboring FGFR2 gene fusions,inhibitory activity against fibroblast growth factor
where FGF-FGFR signaling is known to be activatedreceptors (FGFR)1, FGFR2, and FGFR3. In a kinetic
and rendered drug-resistant by CDK4/6 inhibitors, theinteraction analysis, it was observed that tasurgratinib
standard therapy for ER-positive breast cancer.
demonstrates antitumor activities due to the inhibition
Aiming to overcome drug resistance, a PhaseⅠbof kinase activity by a novel binding mode (Type V)
study in combination with fulvestrant for ER positivethat exhibits rapid and potent binding as well as high
HER2 negative breast cancer is ongoing.

Company Information

Targeting proteins present in cancer, which are difficult to treat
with conventional small molecule inhibitors

cancer. In addition, its activity in combination with
Lenvima® has been confirmed in nonclinical studies.
Furthermore, preclinical studies have suggested that
the Wnt/β-catenin signaling pathway is also involvedin the resistance to immune checkpoint inhibitors,
and the combined effects of E7386 and KEYTRUDA®
have been observed. A PhaseⅠstudy of monotherapy
for solid tumor, PhaseⅠb study of combination
therapy with Lenvima® for solid tumor, and PhaseⅠ/Ⅱ
study of combination therapy with KEYTRUDA® forsolid tumor are ongoing.
Clinical Proof of Concept (POC) has been achieved
based on data on antitumor activity and changes inbiomarkers, as defined in the collaborative research
agreement between Eisai and PRISM BioLab Co.,
Ltd. Going forward, we will further accelerate thedevelopment of E7386.

Aim to cure cancer by understanding individual cancer evolution,from the “ultra-early cancer” stage to the “Drug-resistant cancer” stage, by creation of precision medicine

25

Foundation forSocial Value Creation

LiquidbiopsyEarly cancer

Wnt/β-catenin inhibitor investigational E7386＊
β-catenin has long been known to be a factor that
accelerates the malignancy of cancer. Due to the highdegree of difficulty in drug discovery requiring drug
designs that inhibit protein-protein interactions, it wasconsidered one of Cancer’s Big 4 drug targets, alongwith RAS variants, MYC, and p53 variants. In
collaboration with PRISM BioLab Co., Ltd. (Japan),we have successfully developed E7386, an oral drugthat inhibits Wnt signaling-dependent oncogenesis
and cancer cell growth by inhibiting transcription
through blocking the protein interaction between CBPand β-catenin, leveraging the drug discovery
chemistry expertise we have accumulated over theyears. Since abnormalities in Wnt/β-catenin signaling
pathways have been observed in various types ofcancer, particularly from the early stage of occurrenceof cancer, E7386 is expected to be a treatment not
only for advanced cancer but also for early-stage

Social Value Creation(Human Capital)

The progression of cancer is classified as ultraearly cancer, early cancer, advanced cancer,
and drug-resistant cancer. At each stage, cancer
gene mutations that correspond to canceration,
proliferation, infiltration, recurrence, metastasis, drug
resistance and so on, exist. Our next-generation
medicine creation strategy aims to cure cancer byidentifying these mutations through liquid biopsy

Investigational farletuzumab ecteribulin (MORAb-202)＊
microenvironments that express FRα, such as ovarian
Our proprietary anti-body conjugate (ADC)
cancer.
farletuzumab ecteribulin is a combination of
Eisai entered into an exclusive global strategic
farletuzumab, an anti-folate receptor alpha (FRa)collaboration agreement with Bristol Myers Squibb
antibody, and eribulin, which acts on the cancer(the U.S.) for farletuzumab ecteribulin in June 2021.
microenvironment, both of which were developed
Under this agreement, Eisai and Bristol Myers Squibb
in-house. Farletuzumab ecteribulin is under PhaseⅠ
will jointly develop and commercialize farletuzumab
study in Japan, and PhaseⅠ/Ⅱ study in the Unitedecteribulin in the collaboration territories.
States. It is expected to have antitumor activity byeffectively acting on cancers and cancer o-development with Bristol Myers Squibb＊C

Social Value Creation(Access to Medicines)

Cancer
cells

PD-1

PD-L1

currently working on, and make the most of Eisai’s
own data to create medicine.
We have a promising pipeline at each stage ofcancer progression, and we are also committed
to finding new drug candidates by utilizing external
resources.

Social Value Creation(R&D)■Self-protection of cancer cells against
cytotoxic T cells

we are utilizing liquid biopsy to create a cancer genepanel test kit that enables comprehensive analysis ofmutations in more than 500 cancer genes. Based onthese strategies, we use various analysis methods,
such as AI algorithms based on the vast amount of
human biology obtained from the clinical trials we areManagement Strategies

Main mechanism by which the efficacy of the anti-PD-1 antibody is enhanced by Lenvima® (Non-clinical studies)
Lenvima® is a dual inhibitor that exerts its anti-tumor
macrophages (TAM), which suppresses immune
effect by inhibiting VEGFR, which is involved in
activation, and by increasing activated cytotoxic T cells,angiogenesis, and FGFR, which is involved in resistancewhich attack cancer cells.
to anti-VEGFR therapy. Recent non-clinical studies have
In cancer cells, the FGFR pathway acts suppressively
shown that VEGFR not only inhibits angiogenesis, buton the interferon gamma (IFNγ) pathway, and activation
also regulates the immune system. Studies showed thatof the IFNγpathway based on the FGFR inhibitory
antitumor activity of the anti-PD-1 antibody was
action of Lenvima® is suggested to be important for®
enhanced with Lenvima by reducing tumor-associatedenhancing the efficacy of anti-PD1 antibodies.

26

Eisai Value Creation Report 2022

Manufactured Capital

100%

Stable Supply and Quality Assuranceof expectations of patients and the people in the daily living domain evenduring disasters and pandemics, through a variety of initiatives aimed atsustainable production activity

Under Eisai’s general policy on product quality, “the quality of every single tablet, capsule,and ampule that we produce is integral to the life of the patient,” we will fulfill our mission
and responsibility to continue to ensure the stable supply of high-quality products.

the same time, we will implement other initiatives basedon changes in conditions, including changes inJapanese and international regulations and thedevelopment of innovative technologies, contributing to
the creation of a sustainable society aimed at therealization of a carbon-neutral, decarbonized society.

container has been certified by the Japan BioPlastics
Association for the labeling of biomass plastic products(the Biomass Plamarks). Use of this packaging canreduce CO2 emissions by as much as 70% compared
to conventional petroleum-derived polyethylene. We willcontinue our efforts to further reduce environmental
impact by considering its use with other products. At■ Next-generation Plants Targeting Automation and Remote Operation

Initiatives to Ensure Stable Supply

Pre-mixing unit

Lubrication unitR
 eduction in product loss as scale can be selected inline with demandF lexible adjustments to production in response tochanges in demandS horter overall production times compared to thebatch manufacturingL abor savings through automation and semiautomation, and a reduction in human errorS pace savings achieved by linking multiple processes
in the same workroomR eduction of environmental impact through energy
savingsR eduction of risk of contamination by minimizing
human interventionR educed risk of drug exposure to workers throughcontainment

Batch manufacturing
Volume of raw material is put in according to the size of the machine, and processing and verification repeated in sequence.
Uniformity of products in the process and testing of a representative sample of a portion of the sampling ensures overall quality.
Weighing

Wet granulation unit

Processing

Test

Next process

Partialsampling

OK or Not

Drying unit

Continuous Manufacturing

Raw material feeder

Detector

Biomass plastic container

Continuous processing

Detector

Next process

Continuous monitoring of data from detector
Raw material feeding speed
Equipment operation
Product quality

Batch manufacturing (conventional method): A method in which the processes of feeding raw materials, mixing,
granulation, drying, etc. are independent of each other, and a specific amountof product is processed and produced together.
Continuous Manufacturing (new technology): A production method in which processes such as raw material feeding,
mixing, granulation and drying are linked, with the processes carried out
continuously and simultaneously for a specified length of time.

28

Eisai Value Creation Report 2022

Company Information

Raw material supply and processing, as well as quality monitoring, proceed simultaneously without interruption.
Production volume is adjusted by production time.

Continuous Manufacturing system

27

Intermediate
product

Manual verification(double check)

Foundation forSocial Value Creation[Carbon Neutrality]
As a medium-term target for reducing greenhouse gas
emissions that contribute to global warming, we haveset forth a goal of switching 100% of our total electric
power to renewable energy by fiscal 2030, andachieving carbon neutrality by fiscal 2040.
The manufacturing division has created a roadmap
to achieve this target by fiscal 2040 at all 9 of ourmanufacturing sites in Japan and overseas. We areconsidering and advancing initiatives to reduce CO2
emissions, including the deployment of energy-saving
equipment and solar power generation facilities, fuelconversion from fossil fuels to electricity, as well as
expanded introduction of renewable energy.
In addition, we have adopted a biomass plastic(polyethylene derived from sugarcane) container for the
packaging of the new fine granule formulation of ourantiepileptic agent Fycompa® (generic name:perampanel), which was launched in July 2020.
Containing more than 90% biomass polyethylene, thisSocial Value Creation(Human Capital)[Sustainable Procurement]
Eisai is engaged in socially and environmentallyconscious efforts across the entire supply chain, one ofwhich is our advancement of sustainable procurement.
The goal of this process is to understand our suppliers’commitment to sustainability, including human rights,
labor, health and safety, the environment, and ethics,
and to achieve improvements in these areas throughengagement with our suppliers. In order to realize thesustainable procurement system we created in fiscal
2020, we held two briefing sessions for suppliers infiscal 2021 to help them understand our efforts. We
also requested that our suppliers sign and submit theiragreement to our Code of Conduct for Eisai Global
Business Partners in accordance with the supplier codeof conduct of the Pharmaceutical Supply Chain Initiative(PSCI), of which we are a member, and obtained signed
agreements from 79 domestic and 14 overseas
manufacturing suppliers. In addition, 53 domestic and11 overseas suppliers submitted responses to aquestionnaire on the EcoVadis platform, a tool used by
Eisai to assess the sustainability of its suppliers. Goingforward, we will begin working on sustainableprocurement at our own overseas manufacturing sites
as we engage in building a sustainable global supply
chain.

Social Value Creation(Access to Medicines)■ Initiatives for a Sustainable Supply Chain

Social Value Creation(R&D)

feel anxious about the supply of medicines. In addition,
we have formulated a business continuity plan (BCP),
working to put in place a system for ensuring a stablesupply in the event of a major disaster such as apandemic or problems with a sudden fluctuation indemand. The goal of the BCP is to minimize the impact
of such events and promptly initiate activities aimed atbusiness continuity.
Further, to help realize a sustainable society, we havealso embarked on efforts in the supply chain, including
sustainable procurement and carbon neutrality.

As a human health care (hhc) company, Eisai has been
making an effort to maintain a stable supply of highquality medicines despite the turmoil in society under
the impact of the COVID-19 pandemic. At all 9 of ourmanufacturing sites in Japan and overseas, we give top
priority to employee safety and continue to implement
various infection prevention measures. We also work toverify the operating status of our manufacturingcontractors and raw material suppliers as well as
distribution, and we are strengthening production anddistribution management to ensure that patients do not

progresses, and experiments must be conducted toverify that the same quality of investigational drug can beproduced thereafter. In contrast, the Continuous
Manufacturing eliminates the need for scaling up
manufacturing equipment and associatedexperimentation, since the same production line is used
to manufacture both the investigational drug andcommercial products. Therefore, application of thistechnology meant that, in the development of Tazverik®,
the amount of drug substance was reduced by 40%
and development time shortened by 67% compared tothe conventional batch production method. In
commercial production, the following new value can also
be expected.

Eisai is committed to building a sustainable, robust, andstable supply system to deliver medicines to patients inany environment. By converting our own manufacturing
sites to automated, remotely controlled manufacturing
and analysis operations, we aim to shift to a production
system that, in the event of an emergency, is unaffectedby restrictions on employee attendance. Specifically, we
are working on building a digital twin for the drug
substance manufacturing process (the fusion of reality
and virtual space to realize reaction prediction, remotemonitoring, and predictive maintenance atmanufacturing sites); the development of a Continuous
Manufacturing system for the formulation process; andthe development of an analysis automation robot,
among other efforts.
In particular, in the Continuous Manufacturing system
for the formulation process, we applied this to theanticancer agent Tazverik®, which was approved inJapan in June 2021, making us the first company inJapan to put the system into practical use in commercial
production. In the Continuous Manufacturing, rawmaterial input, mixing, granulation, drying, and otherprocesses are linked to produce the final product while
monitoring the quality of the manufacturing process inreal time. This is an innovative medicine production
technology that can adjust production volume according
to operating hours, and reach high production efficiency
while saving energy. In the conventional production
system (the batch manufacturing), the manufacturing
scale of the investigational drug production equipment
must be increased in phases as development

Management Strategies

Meeting

Social and Relationship Capital←Gauge line

Gauge line→

Remote monitoring camera
Remote control and monitoring of test
initiation, suspension, and resumption

Pipette operation, and detection camera for pipette operation
Accurate measurement and dilution of solutions through detection ofgauge line (line indicating exact liquid volume) and liquid level

Analysis automated robot

Quality Assurance Initiatives

Eisai practices product quality improvement through theintroduction of new technologies so that patients canfeel confident in taking our medicines.
At the Kawashima Industrial Park (Gifu, Japan), we
worked with outside machine manufacturers to jointly
develop a fully automated inspection machine foraluminum pillow packaging, and became the first in thepharmaceutical industry to successfully put it into
practical use in commercial production. Aluminum pillow
packaging is designed to encase a PTP sheet in analuminum sheath to protect products vulnerable tomoisture from humidity. Prior to the introduction of thisinspection machine, the quality of aluminum pillow
packaging was ensured through periodic random
sampling inspections during production. Deployment of
this inspection machine has made it possible to inspect
all product, thereby strengthening quality assurance foraluminum pillow packaging.
Going forward, by incorporating new technologies
into other products, we will continue to build a systemthat provides patients with a stable supply of highquality products in any environment.

Inline pinhole tester for aluminum pouch packages●List of the functions of each plant, and major manufactured items

CountryJapan

Fukushima (EA Pharma)
SuzhouBenxi

Formulation Packaging○

Kashima
Kawashima

APIs

China

○

Major manufactured items
Lenvima®, Dayvigo®, Halaven®, Fycompa®

○○

Lenvima®, Dayvigo®, Fycompa®, Tazverik®

○○

Elental®, Goofice®, Moviprep®

○○

Methycobal®, Merislon®, Aricept®

○○

Transfer factor＊, loxoprofen sodium○○

Pariet®, Aricept®, Methycobal®

○○

Warfarin®, diethylcarbamazine (DEC) tablets,
APIs for generics

Bogor

Indonesia

Vizag

India

Hatfield

U.K.

○

○

Lenvima®, Dayvigo®, Halaven®, Fycompa®

Baltimore

U.S.

○

○

Gliadel®

○＊ Product name in Chinese：转移因子口服溶液

29

30

Eisai Value Creation Report 2022

Company Information

Good Manufacturing Practice (GMP) standards for
manufacturing and quality control of medicines, andconduct appropriate under our corporate concept. We
are striving to foster an organizational culture of bottomup communication and an open workplace climate.
Further, we are mechanizing and automating the
calculation and recording of important data, andseparating the governance of the manufacturing
department from that of the quality control and quality
assurance department. For our contract manufacturing
companies, we dispatch engineers to provide onsite
technical guidance in addition to conducting regular
GMP audits. In the course of conducting these regular
audits and providing technical guidance, in addition toinspecting quality control systems, we are working tostrengthen data integrity assurance at contract
manufacturers by observing actual data acquisition
onsite and verifying records.

 uality Assurance Efforts through Introduction of an Inline Pinhole Tester for Aluminum■Q
Pouch Packages

Foundation forSocial Value Creation

Eisai has built a system to ensure quality that can beutilized with confidence in any country and region of theworld. Medicines can only be delivered to patients once
they conform to national regulatory requirements, but
are also manufactured and tested in accordance withapproved methods and are of the intended quality. At
Eisai, we periodically check for consistency with theapproval document, while also conducting selfinspection of quality management and quality assurance
systems and carrying out risk assessments taking
quality issues at other companies into account. We
have strived to build a quality assurance system thatcan detect quality issues even when they have arisen
from a series of chance events.
Ensuring data integrity in manufacturing andinspection of medicines is also extremely important. We
regularly conduct training to further reinforce data
integrity, including the importance of complying with

Kashima Plant new Quality Building

Social Value Creation(Human Capital)

Ensuring data integrity• Consistent automated operation and recording• Barcode reading and automated printing of sample data
• Automated transfer of generated data to server

to expand the contribution to patients through drug
substance analysis and quality assurance for global
products such as our anticancer agent Lenvima® andthe anti-insomnia drug Dayvigo®.

Construction of a new Quality Building at Kashima Plant(Ibaraki, Japan) was completed in July 2021, based on
the concept of “establishing a QC testing environmentthat provides scientifically reliable information in a timely
and stable manner, and that is trusted both internallyand externally.” Dispersed analysis and testing facilities
have been consolidated in this building, and datareliability enhanced through centralized management ofdata for all operations (testing, data analysis, instrument
and specimen management, stability testing, etc.)
required of a drug analysis facility by means of a test
information system. In addition, by consolidating quality
control and quality assurance organizations based on
an open laboratory, open office design, we expect tostimulate human and intellectual exchange andgenerate innovative ideas. Going forward, we will work

Social Value Creation(Access to Medicines)

Robot arm
• Product dissolution andhomogenization• Automated lid opening andclosing■ Strengthening Quality Assurance System with Construction of New Quality Building in Kashima

Social Value Creation(R&D)

minimize the possibility of operational errors. Further,
consistent and automated operation and recording,
digitalization, and automation of sample data
management, and the automatic transfer of generated
data to servers will contribute significantly to improving
data integrity (completeness, consistency, andaccuracy).
Going forward, we will advance automation andremote operation in the plant, and work to further
strengthen a stable supply system, by further expanding
the scope of automated operations and by studying thepossibility of expanding the system to other products.

Management Strategies

For one of the major products, anticancer agent
Lenvima®, Eisai worked with outside manufacturers todevelop an automated robot to analyze product quality.
The system automates and remotely monitors theseries of operations required when measuring
ingredients and impurities in the product, including
complete dissolution and accurate dilution. It was
introduced in March 2022, and is scheduled to go into
practical use in the first half of fiscal 2022. The
introduction of this equipment is expected to reduce thenumber of days required for testing as a result of asignificant improvement in testing capacity, including theability to work unattended at night. It is also expected toSocial and Relationship Capital

Improving Access to Medicines

Striving to tackle global health issues by utilizing partnerships■ Contributing Towards the Achievement of the SDGs through Initiatives for ATM＊ Source: Access to Medicine Index▶ https://accesstomedicinefoundation.org/■ Continuous Support to Eliminate Neglected Tropical Diseases
threatened by 20 WHO-designated NTDs. In line with
the WHO’s road map for NTDs 2021-2030, the Kigali
Declaration, a collective commitment from stakeholders
aiming to tackle NTDs through strengthening country
ownership and improving multi-sectoral partnerships,
was announced at the Kigali Summit on Malaria and
NTDs on June 23, 2022 in Kigali, Rwanda. Eisai signed
the Kigali Declaration and expressed its continued
commitment to the elimination of NTDs through theprovision of DEC tablets free of charge and efforts todevelop new treatments for NTDs.

LF is one of the NTDs transmitted to humans via
mosquitoes. It is estimated that approximately 863

million people worldwide, mainly people living indeveloping countries, are at risk of infection. The WHO

31■ Contribution to Tackling Mycetoma, the Most Neglected Tropical Disease
Mycetoma is one of the most neglected tropical diseases
that is transmitted through the skin. The main symptom isthe appearance of large lesions on the hands and feet,
which, as the disease progresses, can interfere withwalking and working. In endemic regions, the disease hassocial consequences including discrimination due toprejudice and economic damage to those affected. Eisaiis engaging in development of new treatments anddisease awareness raising for mycetoma throughpartnerships with the Mycetoma Research Centre in
Sudan, Drugs for Neglected Diseases initiative (DNDi),
Global Health Innovative Technology Fund (GHIT Fund)and the Association for Aid and Relief, Japan (AAR
Japan), an international non-governmental organization.
Since 2019, Eisai has been supporting AAR Japan to help
it tackle mycetoma in Sudan. We have contributed to the
local communities by providing treatment and surgery toapproximately 100 patients with mycetoma, andconducting disease awareness raising for more than
2,400 residents since the start of our activities. We are

expanding collaborations with AAR Japan based on theshared mid-term activity goals of tackling mycetoma via aholistic and sustainable solution, which includes provisionof psychological care to post-operative patients andcapacity building for local organizations. We created an
animated video emphasizing the collaborations withpartners. We will continue to work with global partners torelieve the anxieties of patients and their families who are
suffering from mycetoma.

Please visit the following Website to watch the animated video
https://www.eisai.com/sustainability/movie/index-2.html■ R&D through Partnership
Eisai proactively conducts research and development on
new treatment candidates for three major infectious
diseases: acquired immunodeficiency syndrome (HIV/
AIDS), tuberculosis, and malaria. These diseases spreadwidely among the people living in poverty in developing

countries, and the vicious cycle of a declining labor force
due to diseases leading to further poverty has become
an international issue. In response, we are currently
conducting various projects aimed at developing newtreatments for mycetoma, LF, and leishmaniasis, as well

32

Eisai Value Creation Report 2022

Company Information■ Efforts to Eliminate LF amid COVID-19 Pandemic: Collaboration with Partners

Letter of gratitude from the governmentof Papua New Guinea

Foundation forSocial Value Creation

Endorsement of the Kigali Declaration
Please visit the following Website to watch the joint message video from CEOs of global
pharmaceutical companies contributing to the elimination of NTDs.
https://www.eisai.com/kigalideclaration/index-3.html

Masks and gloves delivered to Papua New Guinea

Social Value Creation(Human Capital)

Infectious diseases caused by parasites or bacteria thatare prevalent mainly in tropical and subtropical regions
have not been considered as major diseases, andtherefore, are called “neglected tropical diseases(NTDs).” Eisai views its initiatives to combat NTDs as
a business domain guided by its human health care(hhc) concept. To combat an NTD called lymphatic
filariasis (LF), Eisai signed a joint statement with theWorld Health Organization (WHO) in November 2010 toprovide diethylcarbamazine (DEC) tablets, a treatment
for LF, free of charge. In January 2012, Eisai participatedin the London Declaration, a coordinated effort toeliminate 10 NTDs, and the largest international publicprivate partnership in the field of global health at thatmoment, as the only Japanese company. Since theLondon Declaration, the pharmaceutical companies
involved have donated high-quality therapeutic drugs
for 14 billion people. Under this partnership, efforts toeliminate NTDs have resulted in at least one NTD and
600 million people in 46 countries no longer needing
intervention for NTDs. LF has been eliminated in 17
countries and the number of infected people has
declined by 74% compared to 2000. Despite suchprogress, more than 1.7 billion people remain

Vizag Plant staff educating children about LF (India)

Social Value Creation(Access to Medicines)

We believe that initiatives to improve ATM in developing
and emerging countries are a long-term investment thatwill support the health of the people living in thesecountries and ultimately lead to the future growth of thesenations. We continue to implement various ATM initiatives
through our unique business models, such as leveraging
public-private partnerships.

Eisai is engaged in activities to improve ATM, with the aimof ensuring that people in developing and emerging
countries receive the medicines they need. ATM is a basic
need for all people regardless of nationality, economic
status, or social standing. Today, approximately 2 billion
people＊ around the world do not have adequate ATM,
most of whom are people living in poverty in developing
and emerging countries who also lack proper information
about health and diseases.

Social Value Creation(R&D)“We want people to find hope, by delivering necessary medicines to as many people as possible.” Putting thiswish into practice, Eisai is engaged in activities to improve Access to Medicines (ATM) in developing and emerging
countries.

Due to the global spread of COVID-19, activities toeliminate NTDs in endemic countries have been
postponed. Despite the challenging circumstances,each country was very eager to eliminate NTDs. Eisai
supported implementation of MDAs in Papua New
Guinea in fiscal 2021 by providing masks and gloves for
infection prevention measures in collaboration with theJapan International Cooperation Agency (JICA).
Materials were used in MDA campaigns in West New
Britain province. We received a letter from the National
Department of Health of Papua New Guinea expressing
their appreciation for Eisai’s consistent support for the
LF elimination program through the supply of DEC
tablets and the donation of masks and gloves.

Management Strategies

Working toward the elimination of lymphatic filariasis (LF) by 2030,
by providing diethylcarbamazine tablets to endemic countries,and supporting procurement of LF diagnostic kits to evaluateelimination progressconducts mass drug administrations (MDAs) in endemicareas to eliminate LF. Eisai is committed to supplying
DEC tablets, one of the three types of LF treatments
used in the MDAs, to LF endemic countries that needDEC until LF is eliminated.
DEC tablets are manufactured at our Vizag Plant inIndia and we have provided 2.05 billion tablets via the
WHO to 29 LF endemic countries (as of the end of
fiscal 2021). In addition, we have provided financial
support to the WHO to provide diagnostic kits free ofcharge, for use in evaluating the success of MDAs in LF
elimination and helping to determine when MDAs canbe stopped. We have supported the provision ofdiagnostic kits to 40 countries in 5 years since the startof the program in 2015.

PhaseⅡ/Ⅲ study in partnership with the DNDi in Sudan,
one of the countries where the disease is most prevalent.
Malaria is a serious infectious disease, which infects
approximately 230 million people and kills more than 400
thousand people per year. In recent years, resistance toexisting drugs has been reported, and the developmentof new drugs has become an urgent task. For thisreason, various projects are ongoing to combat malaria,
including partnerships with the University of Kentucky in
the United States and the Swiss non-profit Medicines for
Malaria Venture (MMV).

Exploratory research on
Trypanosoma PDE inhibitors ①

Non-clinical

Clinical

AWZ1066S ④

Mycetoma

E1224 Eumycetoma project(Phase Ⅱ/Ⅲ study) ⑤

Malaria

BRD5018 ⑪

Screening of novel compounds ⑦

E1511 ⑫

Malaria vaccine(using immunostimulant E6020) ⑧

SJ733 (suppository formulation) ⑬

Inhibitors of
Iysyl t-RNA synthetase ⑨

Anti-CSP monoclonal antibody ⑭

SJ733 (Phase Ⅱ study) ⑮

Exploratory research on
prophylaxis by ASOs ⑩
Inhibitor of tryptophan synthase ⑯

R&D Consortium for NTDs and3 major infectious diseases

WIPO Re:Search ⑰
NTD Drug Discovery Booster ⑱

TB Drug Accelerator ⑲

R&D Consortium for Pandemic andAntimicrobial Resistance (AMR)

COVID-19 Therapeutics Accelerator ⑳

AMR Screening Consortium ㉑●Supply of products based onaffordable and tiered pricing
strategies

Human capital●Improvement in employees’skills and motivation
Financial capital●Reduced cost of
manufacturing due toincreased operation rate
at the Vizag Plant●(Long-term perspective)
Profits created throughbusinesses in developing
and emerging countries

Social and Relationship capital●Partnership with the WHO orinternational research institutions⑪ Broad Institute (U.S.), Department of Defense (U.S.)⑬ University of Kentucky (U.S.), Medicines for Malaria Venture (MMV) (Switzerland)⑭ Ehime University (Japan), GlaxoSmithKline plc. (U.K.), PATH (U.S.)⑮ University of Kentucky (U.S.)⑯ Broad Institute (U.S.), Colorado State University (U.S.), University of Chicago (U.S.)⑰ World Intellectual Property Organization (WIPO) (Switzerland), BIO Ventures for Global Health (BVGH)(U.S.)⑲, ⑳ Bill & Melinda Gates Foundation (U.S.)㉑ Global Antibiotic Research and Development Partnership (GARDP) (Switzerland)

Please visit the following link for details on projects ▶ https://www.eisai.com/sustainability/atm/research.html■ Pricing Policy that Emphasizes Affordability

For the purpose of facilitating the improvement ofATM, Eisai utilizes many different types of capital as
inputs and converts them into different forms of output(products and services), such as provision of DEC
tablets, through business activities. As a result, we
pursue the creation of positive outcomes, such as the
improvement of health, welfare and economic growthby increasing the size of the middle-income
populations in developing and emerging countries.
Eisai also seeks to enhance the value of its corporate
brand, improve employees’ skills and motivation, andreduce costs by increasing the operation rate of theVizag Plant, as positive internal outcomes. We believethat efforts to improve ATM will increase capital to an
extent that is greater than the amount of input, throughthe creation of added value. Eisai’s initiatives for
improving ATM go beyond the framework of CSR
activities and aim at creating long-term value.
Supplying DEC tablets free of charge will initially be aloss, and will thus negatively affect profits and ROE inthe short term. However, from a long-term perspective,
we anticipate that it will boost our net present value(NPV) to a positive level through the creation of theoutcomes described above.

■ Expansion to Africa Leveraging our Base in India
Eisai has initiated sales of global brands, such as
Lenvima® and Halaven®, in partnership with local
distributors in Africa since 2007. In order to expand
access to Eisai’s products and address local social
issues including global health in Africa, we decided toestablish a subsidiary, Eisai Pharmaceuticals Africa (Pty)Ltd., in Johannesburg, South Africa, as well as a branch
office in Nairobi, Kenya. We aim to relieve people’sanxiety over health and address health inequality by
optimizing management resources including the Vizag
Plant in India, leveraging existing Africa-India healthcare
linkages and networks that include stakeholders in thefield of global health such as NTDs and malaria, as well
as utilizing our experience in telemedicine technologies
used in China. We are preparing for the establishmentof our own marketing structure in fiscal 2022.
Expansion to Africa, Leveraging our Base in India
EAC(East African Community)

Eisai India
Africa regional lead

Population:

200 million
Mumbai

Kenya

NairobiVizag

Eisai Kenya
Branch Office(Nairobi)

SADC(Southern African
Development Community)
Population:

360 million

South Africa

Johannesburg

Eisai South Africa
New Company(Johannesburg)

Aim to solve access to
medicine issues

Foundation forSocial Value Creation■Main partners in the projects① Universidad Nacional de La Plata (Argentina)② Sabin Vaccine Institute (U.S.)③, ⑤, ⑱ Drugs for Neglected Disease initiative (DNDi ) (Switzerland)④ Liverpool School of Tropical Medicine (U.K.), University of Liverpool (U.K.)⑥ Broad Institute (U.S.), Medicines for Malaria Venture (MMV) (Switzerland)⑦, ⑫ Medicines for Malaria Venture (MMV) (Switzerland)⑧ Fundação Oswaldo Cruz (Fiocruz) (Brazil)⑨ University of Dundee (U.K.), Medicines for Malaria Venture (MMV) (Switzerland)⑩ University of California, San Diego (U.S.)●Activities for raising awarenessof lymphatic filariasis

Social Value Creation(Human Capital)

Tuberculosis (TB)

●Supply of LF treatment DEC
tablets free of charge

Social Value Creation(Access to Medicines)

Filariasis

Inhibitor of DHODH ⑥

OutcomeSocial and Relationship capital●Economic growth indeveloping and emerging
countries due toimprovement of health andwelfare, and increase in labor
force and middle-income class●Enhancement in the value of
Eisai’s corporate brandFinancial capital●Strong balance sheet

Chagas vaccine(using immunostimulant E6020) ②
DNDI-6174 ③

Leishmaniasis

3 Major
Infectious
Diseases

Human capital●Employees’ strong motivation
to contribute to patients’
well-being supported by the“hhc” concept

OutputSocial Value Creation(R&D)

Early research stage

Neglected
Tropical
Diseases(NTDs)

Input
Intellectual capital●Accumulation of knowledge
from medicine creation
activities over many years

Production capital●Utilization of the Vizag Plant
in India for low-cost
production●NTDs/Infectious diseases research project portfolio (as of July 2022)

Chagas Disease nhancement of Corporate Value and Solutions to Social Issues through Initiatives for■E
Improving Access to Medicine (ATM)Management Strategies

as malaria and tuberculosis. These research anddevelopment activities require tools and technologies fordisease research, experience in clinical studies in endemic
regions, and networks with clinical study sites. For thesereasons, we are actively engaged in external
collaborations across all projects, such as partnerships
with global research organizations, and participating ininternational consortiums aimed at sharing compound
libraries.
Eisai is aiming to develop our in-house discovered
antifungal agent fosravuconazole (E1224) as a newtreatment for mycetoma. Currently, we are conducting a

Achieving the SDGs

Aim to extend our commitment to relieve anxiety over healthand address health disparities for people in Africa

33■ Relationship with Society: Visiting Elementary School to Give Lectures on ATM
Eisai employees visited the Makuhari Elementary Schoolin Chiba City, Chiba prefecture, Japan to give lecturesand introduce Eisai’s efforts to achieve the SDGs
through activities aimed at improving ATM. This was thefirst occasion on which Eisai employees became
volunteer lecturers and gave SDGs related lectures forelementary school pupils. During the lecture, pupils
were asked to think about “the efforts each individual

can make to achieve the SDGs as a member ofsociety.” They listenedcarefully to the lecture
and asked so manyquestions that we
could not answer them
all within class hours.
Lecture at an elementary school

34

Eisai Value Creation Report 2022

Company Information

completely free under certain conditions. Furthermore, aPatient Assistance Program (PAP) has been introduced
for Lenvima® in 9 Asian countries, for Halaven® in 7
countries and for Fycompa® in 3 countries, to support
access to medicine for patients who are economicallydisadvantaged.

Eisai has formulated flexible pricing policies that enable
patients in developing and emerging countries topurchase Eisai’s products at affordable prices. For
example, a tiered pricing system has been introduced for
anticancer agents Lenvima® and Halaven® in India. Under
this system, copayment is reduced in stages according
to the level and insurance coverage status, and isHuman Capital Human Resource Strategies

We will continue to provide DEC tablets, one of thetherapeutic agents for lymphatic filariasis (LF), to LFendemic countries in collaboration with the World
Health Organization (WHO) and others, until thedisease is eliminated.
Yanagi and Freiberg (2022) calculated the social
impact of free provision of DEC tablets using theimpact-weighted accounting (IWA) method (Table 1
and 2)＊.
＊ The article was published in “Monthly Capital Market” September 2022 issue “ESG Accounting for offering neglected tropical disease treatment with price zero innovative measurement of product impact accounts in global health.” Ryohei Yanagi
and David Freiberg (2022)
Ryohei Yanagi is Visiting Professor of Waseda University and former CFO of Eisai
Co., Ltd. David Freiberg is a founding member of the Impact-Weighted Accounting
Initiative (IWAI) of Harvard Business School.

calculated by multiplying the minimum wage by theworking hours that can be recovered by patientsand those who can avoid infection through drug
treatment, multiplying the number of subjects and life
expectancy, and taking into account the health carecosts that can be saved.

●Table 1. Social impact of free provision of DEC tablets

(Unit: Millions of yen)Social Impact of Lifetime

Annual Average Social Impact

Benefit Cohort 1＊1

7,696,728

178,994

Benefit Cohort 2＊2

5,072,366

117,962

765,921

23,210Total Social Impact

13,535,015

320,165

Social Impact Created by Eisai’s Contribution

6,767,507

160,083

Source: Yanagi, Freiberg (2022)＊1 Benefit Cohort 1: People who have avoided being infected with LF through reduction of the risk population with mass drug administration (MDA)＊2 Benefit Cohort 2: People infected with LF who were able to avoid aggravation of their condition from asymptomatic to clinical illness＊3 Benefit Cohort 3: People who have been infected with LF and are in a state of clinical illness but have been able to avoid further deterioration of their conditionas value creation, our EBITDA would approximately
double, suggesting that the intrinsic corporate value
would approximately double (Table 2). In productimpact accounting, significant corporate value wascreated by the free provision of DEC tablets, atreatment for the neglected tropical disease LF, and we
can say that we were the first in the world to quantify
and disclose product impact on global health.

●Table 2. Impact-weighted accounting in free provision of DEC tablets (Eisai’s product impact accounting) fiscal 2018

fiscal 2019

(Unit: Millions of yen)fiscal 2020

642,834

695,621645,942EBITDA

120,805

163,618

92,877

Product Impact of DEC tablets

160,083

160,083

160,083

Total Profit of Impact-Weighted Accounting

252,960

280,888323,701

Ratio of Impact on Revenue (%)

25%

23%

25%

Ratio of Impact on EBITDA for Financial Accounting (%)

133%

98%

172%

Source: Yanagi, Freiberg (2022)

The Premise of Product Impact Accounting
provided 1.6 billion DEC tablets over five years,
taken by 150 million people. Applying the model ofTurner et al.＊, 7.6 million people can avoid chronic
LF, and 1 billion attacks can be avoided even in theacute phase of LF based on the number of users.
• The calculation is limited to the countries/regions
where MDAs were performed with a combination of
two LF treatments, Eisai’s diethylcarbamazine (DEC)and GSK’s albendazole. Assuming that our social
impact contribution belongs to a 50:50 ratio, we cansay that half of the total impact was Eisai’s social
impact creation.
＊ Turner et al., Infectious Diseases of Poverty (2016) 5:54

35

Eisai’s Vision for HRE isai values the ability of employees to build their dreams based on their individual missions and reasons for working. For
employees striving to achieve those dreams, we provide rewarding work, opportunities for growth and a comfortableworking environment. From our employees’ diverse dreams, we will realize hhceco to make an even better society.
Through socialization with patients and the people in the daily living domain, Eisai employees define their own social
missions and reasons for working, and build diverse dreams for themselves. While striving to realize those dreams, they
are the ones who bring about a better change in society.
E isai will create a large, symbiotic group and a corporate culture where diverse talents gather to realize hhceco, where
every employee can unleash their own individuality, thrive and grow.
E isai employees recognize, utilize, and learn from one another’s aspirations and values. We will foster a workplace thatrejoices in and supports new challenges, and continues to pursue better results through the successes and failures thatarise from those challenges.
B ecause Eisai employees play a leading role in helping patients and the people in the daily living domain “to live their lives
to the fullest,” and must therefore be healthy in mind and body, full of the energy needed “to live their own lives to thefullest.”36

Eisai Value Creation Report 2022

Company Information• Social impact of free provision of DEC tablets for five
years from 2014 to 2018, based on the contract with
WHO, was quantified based on the IWA method.
• The 5-year free provision of DEC tablets was 1.6
billion tablets at a total investment (manufacturingcost) of approximately 2.4 billion yen, and DEC tablets
were provided to 25 developing countries to be used
for MDAs in combination with GSK’s LF treatment.
• According to the WHO guidelines, an average of
2.5 DEC tablets are taken per person per MDA(varies depending on body weight), and LF canbe controlled by MDA once a year for 5 years. We

Foundation forSocial Value Creation

Revenuethe same time, we will
foster a workplace culture
in which employees
continue to pursue better
results through thesuccesses and failures thatarise from new challenges.
We will also proactively
disclose information about
our efforts to build hhceco
and the HR strategies that
Teruyuki Masaka
Vice President
will contribute to a
Chief HR Officer
sustainable growth story.
To achieve these goals, we intend to further advancehighly effective human resource initiatives through HR
data analysis.
On a global level, we analyze how many leaders areneeded in which regions to achieve our management
strategies, and what capabilities those leaders should
possess. We then acquire and assign appropriate
talents and implement programs to develop the next
generation of leaders. We will also promote thedevelopment of new work environments that will enablehighly productive work under any circumstances,including the spread of COVID-19. Further, we are
actively working to introduce a talent management
policy that will enable our employees, who are thedriving force behind the realization of hhceco, to eachlead fulfilling lives—to live their lives to the fullest—in
good physical and mental health.
We would like to realize hhceco, which solves social
issues such as dementia, by providing employees who
are trying to realize their dreams with work they feel ismeaningful, growth opportunities that support selfrealization, and a comfortable working environment andsystems.

Social Value Creation(Human Capital)

In this way, the social impact of our free provision of
DEC tablets is estimated to be approximately 7 trillion
yen, and if it is divided by the average life expectancy(43 years for Benefit Cohort 1 and 2, and 33 years
for Benefit Cohort 3), the annual average social
impact from Eisai’s contribution was calculated to beapproximately 160 billion yen. If this approximately 160
billion yen is added to EBITDA in financial accounting

At the 110th Ordinary General Meeting of Shareholders,the Corporate Concept in our Articles of Incorporation
was amended for the first time in 17 years. We haveredefined the main object of our Corporate Concept as“the people in the daily living and medical domain,” andexpanded the scope our contributions should coverfrom “patients and their families” to “patients and thepeople in the daily living domain” While adhering to ourhhc concept, our goal is to evolve into a company that
supports people throughout their lives (empowering
them to live their lives to the fullest) by establishing an
ecosystem model (hhceco) of collaboration with otherindustries to further increase the satisfaction of ourpatients and of people in the daily living domain. The
key to achieving this is the “employees.” The Articles ofIncorporation clearly list “employees” as a principal
stakeholder group, and in addition to ensuring “stable
employment,” already noted in the Articles, we haveadded “respecting human rights” and “diversity,”“providing full opportunities for growth in support of selffulfillment,” and “creating an employee-friendly
environment.”
In today’s era of accelerating diversity of humanresources in terms of nationality, age and gender, there
is an increasing diversity in work styles and values, andthe concept of human capital as the source of acompany’s products and services is gaining greaterattention by the year. In addition, as the ratio of humaninvestment to GDP in Japan stagnates, “investment in
employees” was incorporated in the Basic Policy on
Economic and Fiscal Management and Reform
formulated by the Cabinet Office, and the developmentof human talent capable of generating added value has
become a national-level issue. Eisai will also create anenvironment in which employees can recognize, utilize
and learn from one another’s aspirations and values. At

Social Value Creation(Access to Medicines)

Benefit Cohort 3＊3

Message from the Chief HR Officer

Social Value Creation(R&D)

We have provided 1.6 billion DEC tablets free ofcharge in 25 developing countries in the five years
from 2014 to 2018, which is the period coveredby this collaboration. The social impact generated
by the free provision of DEC was calculated to beapproximately 7 trillion yen (Table 1). This figure was

Working to enhance job satisfaction for each and every employee who
is “empowering people to live their lives to the fullest”

Management Strategies

Visualization of Non-Financial Capital:
Impact-Weighted Accounting of Free Provision of Diethylcarbamazine (DEC) TabletsMateriality in HR Strategies

Materiality

Priority actions

Reference indices• Global survey results, pulse survey results• Status of succession plan execution• Frequency of and satisfaction with one-on-one meetings• Frequency of communication outside the organization•N umber and diversity of employee participants in global training programs•N umber of employees participating in internal training (re-skilling) andvoluntary participation rate•N
 umber and diversity of employees dispatched to external training programs• Diversity, etc. in hiring and promotions

Preparing asuitable working
environmentand healthcare
support to assist
self-actualization• P utting in place support and an environment for the health of employees andtheir families• Building programs to encourage new challenges• Reforming awareness of working hours• E stablishment of human resource systems (including a secondary employment
system) to accommodate diverse working styles, motivation, and growth• Validate measures for disease prevention and support for people who continue
to work during treatment• Validate measures for improving skills, enriching lives, and supporting careers• Rectification of long working hours• Rates at which leave is taken and work from home promoted• Retention and turnover rates• R atio of individuals undergoing regular health checkups and follow-up on thosewith findings• Number of participants in re-skilling training• Number of users of various support programs, etc.

●3 Actions to Focus on
Talent management that draws out and utilizes diverse ideas rooted
in empathy with the hhc concept
Empathy with the hhc concept and employee autonomy
To enable diverse employees to develop business together, it is important “to instill our corporate concept.” Employees share with each other insights gained from “socialization,” the process ofspending time with patients and their families, and develop and implement specific action plans to meet potential patient needs. Through this “socialization,” we encourage employees to gain an
intrinsic motivation for realizing our corporate concept, discover for themselves the meaning of work, and take on the challenge of bringing better changes to society.

Acquiring human talent and providing opportunity
We will secure diverse experiences and perspectives not yet fully leveraged in management through ongoing efforts to develop and promote the careers of female employees, encourage male
employees to take parental leave, promote mid-career hiring, and foster and promote employees once they have joined the Company. In addition, to allow each employee to gain diverse
experiences and perspectives, we are expanding opportunities, including for cross-border experiences in and outside the company and leave for self-development.

Topics for Fiscal 2021

Fostering an organizational climate

1. Talent management to support business strategy＊ Collection and analysis of data regarding employees and organizations●Initiatives Overseas

Priority issues

Fiscal 2021
Key initiatives●Results of fiscal 2021 global engagement survey
Understanding of Diversity & Inclusion

Environment for generating innovation

Initiatives planned
for fiscal 2022

EuropeAsia

Focus on advancing the following as part ofEquality, Diversity & Inclusion (EDI)1) Awareness and understanding of EDI2) Clear vision & strategy
3) Establishment of governance and implementation4) H R policies promoting diversity (hiring, training,career development, etc.)
5) Data collection and communication

China
Enhancing work efficiency through a hybrid work
style combining remote and in-office work, andpromotion of the following 2 items1) M aintaining a ratio of female managers of 30%
or more2) P romoting work style reforms by expanding therange of individual discretion in choosing work
locations and working hours
India
Gender diversity• Integrated DE&I trainings into 2 key leadershipdevelopment programs•W orkshops, luncheons, and learning opportunities
offered, along with social media outreach• Initiatives for establishment of a strong presenceat diversity-related conferences and job fairs• Inclusion of items such as gender and ethnicity inthe talent review and development process• E qual pay for equal work surveys conductedcompany-wide to ensure there are no wage
disparities based on gender or ethnicity• Investments made in programs in which
employees can participate to rectify healthdisparities• Inclusion of EDI priority items in corporate goals
and areas of focus• Changes in governance structure•C onducted first audit of EDI situation and activities(the U.K.)• Initiatives conducted based on national labor laws
(Spain, Italy)• Creation of employee diversity monitoring data

China
•H
 ybrid work style introduced 1 day a week on apilot basis and then started formally• R atio of female managers: Reached 47%
India• F ocused on increasing the number of female
employees, and repeatedly communicatedmessages about their importance and related
initiatives at town hall meetings and monthly
meetings• Announcement in July 2022 expressing top
management’s commitment to DE&I and initiating
a series of workshops.
• In August 2022, the Company plans to participate
in a diversity job fair, with a focus on medical
representatives (MRs)• E DI concept, common vision, and objectives
to be shared in “learning journey” for senior
management• P romote activities centered on the establishmentof a Europe-wide EDI project through theformation of an EDI governance structure andaction committee

China•Maintain a target of having 30% or moremanagement positions held by female employees,
and implement initiatives such as providing
opportunities for female employees to havedialogue with female leaders, incorporating healthpsychology for women into employee healthmanagement, etc.
India
• Identify concerns that female employees at the
manufacturing plant have, and encourage thedevelopment of career plans and participation ina variety of forums•C onsider proactive hiring of female leaders

Overall engagement with the Company
020■Company-wide■Japan ■Americas＊1 ■EMEA＊2

40

60

80

100 (%)■China ■Asia and Latin America＊3＊1 North America ＊2 Europe, the Middle East, Africa, Russia, and Oceania ＊3 Korea, Taiwan, Hong Kong, India, ASEAN, Central and South America, etc.

37

38

Eisai Value Creation Report 2022

Company Information

Empathy with concept and vision

The U.S.
We are advancing initiatives in the following 4
areas, which have been positioned as priority
issues.
1) Awareness-raising activities
2) Increase representation of diverse talent3) Growth and development of diverse talent4) Support health equity initiatives for all employees

Foundation forSocial Value Creation

extremely high, at 95%, while items related to corporate
ethics exceeded the benchmark by more than 10%.
This clearly indicated that management based on hhc
and compliance has permeated the Company and has
become one of its strengths. On the other hand, there
remained room for improvement, especially in Japan, in
terms of fostering a culture in which creative discussions
are based on knowledge gained from empathizing withpatients and people in the daily living domain, and inwhich diverse values are mutually recognized andopinions shared. This global survey will be continued on
an annual basis, and will be assessed as an indicator of
the enhancement of human capital and actions aimed
at improvement implemented.

Social Value Creation(Human Capital)

1) Global engagement survey
We see the foundation of our HR strategy as helping
our employees to grow attached to their jobs and to theCompany, and to increase their productivity whileproviding them with a sense of fulfillment and job
satisfaction, which in turn leads to patient and customer
satisfaction and improved business performance. In
Japan, a monthly survey of employee engagement was
introduced in fiscal 2020, and, based on those scores,
is being used for discussions and improvements in theworkplace and for people analytics＊. In addition,
beginning in fiscal 2021 we are introducing a global,
company-wide engagement survey. In the first such
survey, the ratio of highly engaged employees was
85%, higher than the average for global pharmaceuticalcompanies. Notably, the level of empathy with andeveryday practice of our corporate concept was

In order to leverage diversity to create new value and realize hhceco, it is important to have an organizational climate that accepts and makes use of perspectives, ideas, and values that are not simply an
extension of conventional thought. From the results of the global engagement survey mentioned above, we found there were issues around fostering an organizational climate which allows employees to shareopinions based on diverse values. In response, we are focusing on fostering organizational management and a climate that accepts and acknowledges differences, including training in unconscious bias.

Social Value Creation(Access to Medicines)• Implement data-driven talent management policies• Operate programs that support employee self-realization• Acquire diverse human talent to support business growth• R eform corporate climate through policies to strengthen management andpromote dialogue within the organization• Implement programs to develop next generation of global leaders• Promote Diversity, Equity, and Inclusion (DE&I)

Social Value Creation(R&D)

Talentmanagement tosupport businessstrategyManagement Strategies

on the demands of society and priority issues in thebusiness environment. This is also an important item as
we work to realize our long-term vision, towards which
we will implement a PDCA cycle in conjunction with ourbusiness plan.

Eisai will put in place an environment in which every
employee can work independently and aggressively
toward realizing our vision, based on a strong sense of
empathy with our corporate philosophy. To achieve this,we have identified materialities in human capital based

2) Talent management that draws out and utilizes diverse ideas rooted in empathy with the hhc concept
and the people in the daily living domain,” we are further
Eisai is an hhc company that takes an approach whichstrengthening Diversity, Equity & Inclusion (DE&I)
places the main focus on patients and people in thethroughout the Company to ensure we have thedaily living domain when considering things, and we arediversity to meet the increasingly diverse needs.
continually striving to understand the true thoughts andWe have identified the following 3 actions we should
feelings of patients and of people in the daily living
focus on, and are developing initiatives to meet thedomain. In expanding our business perspective fromchallenges in each region.
the previous “patients and their families” to “patients

Diversity & Inclusion 2021,” we have established thefollowing 3 goals and action plans to be implemented byfiscal 2030.

Develop autonomous human talent capable of respecting diverse values•P romote a shift from company-led career development to proactive career development based on individual employees’
diverse values and willingness to take on challenges•E xpand opportunities for crossing borders to gain diverse experience both in and outside the company, providing newopportunities that will lead to employee growth and career development●Ratio of female managers and female employees

20.7 20.9 21.2 21.5

22.8

24.2

30s and younger

(%)
60

26.0

59.3

55.7

10
5.0

6.0

7.0

8.0

49.4

57.1

50s and older

48.6

45
42.5

9.6 10.4

60.0

40s

37.4

30

11.5

15

34.3

1.7

3.3

5.7

2016

2017

2018

39.3

34.2

11.3

8.7

Each employee is surrounded by diverse conditions andvalues. Based on the concept of Work Life Best (WLB),
which aims for the best of both work and life for
employees, we are promoting the development of aworking environment in which employees can work in ahighly productive and healthy manner under a variety ofconditions. To improve WLB for our diverse members,
we carried out office renovations based on Activity
Based Working (ABW), which allows employees tochoose their working environment and location basedon when and where work is most productive and best
contributes to the expression of creative results. We
also conducted trials of shared office use and an inhouse social media site for a portion of our employees.
In addition to flexibility in terms of where and whenemployees work, we have also established systems
under sound labor-management relations to support
self-development and study abroad, in order to

Genealogy of Work Style Reforms
More Diverse
Members andWork Styles

37.3
14.1

0

0
2015

2020

2025

2030

2020

Flexibility inWork Locationsand Hours

2021

Figures as of the end of each fiscal year

Enhanced work-from-homesystem(can be used for other thanchildcare and caregiving)

Uniform working hours forall business sites

Nurturing an organizational climate●Percentage of spousal maternity leave and malechildcare leave taken of five days or more
(%)
60
42.5

45
30

22.7

Balancing Workand Life
2012 Mandatory retirement
age changed to 65

46.9

Work-from-home systemfor childcare and caregiving

Refresh leave at age 60

28.2

15

2017

Combined system ofshorter working hours
for childcare, etc.
and flextime
Enhanced requirements
for application of
long-term medical leave(cancer, dialysis,
infertility treatment)

Shortened core hours
for flextime system

Leave of absence
for accompanying spouseassigned overseas

Improved conditions including
leave of absence and vacation
for temporary andpart-time workers anda continuous employment system
Added application of welfare
mutual aid society membership,
stock ownership plan,
and asset savings plans for
temporary and part-time workers

Establishment of new leavefor self-development andsocial contribution activities

Empowering
People to Live
Their Lives to
the Fullest

Establishment of new leaveof absence for privately
funded study abroad
Introduction of optional
defined contribution
pension plan for temporary
and part-time workers

Shortened core hours
for flextime system

Company mobile phones
distributed to all employees

Introduction of interval
compensatory leave

Abolishment of limits on numberof times work-from-home
option can be used

Introduced a system of shorter
working hours for employeeswith personal injuries or illnesses

Elimination of core hours
for flextime system

Establishment of new
spousal maternity leave

Expansion of work-from-hometo employee’s family home

Eisai Health
Declaration issued

Introduction of system fortaking nursing and caregiving
leave by the hour

2019

2018

Liberalization of dress
code based on self-branding
and self-management

2020

Ongoing work
environment
improvements
based on the
WLB concept・・
2021 2022 ・

・
・
・

0
2018

2019

2020

2021

2022 (forecast)

Figures as of the end of each fiscal year
＊ IkuBoss: Bosses (upper and line managers) who consider the work-life balance of subordinates and staff working together in the workplace and who support their subordinates’ careers andlives, while achieving organizational results and enjoying their own jobs and personal lives

39

40

Eisai Value Creation Report 2022

Company Information•C ontinue to provide training on unconscious bias for all employees•P rovide guidelines for improving engagement and maximizing
business performance by visualizing the activities of each employee
and activating internal communication, and continue to provide
one-on-one training for management–P rovide managers with training in childcare support systems and“IkuBoss＊”–F oster a workplace climate that encourages both male andfemale employees to take childcare and caregiving leave, etc.,with the goal of quickly achieving a 50% utilization rate forspousal maternity leave and childcare leave among male
employees

Enhanced mobile working
for outside workers(expansion of work-from-home)

Foundation forSocial Value Creation

Figures as of the end of each fiscal year

2019

enhance employee autonomy over work styles andgrowth potential.
Given that the health of our employees, who areresponsible for realizing our hhc concept, is of utmost
importance, in 2019 we issued “the Eisai Health
Declaration,” promoting activities to maintain andimprove employee health. In addition to one-on-one
meetings between supervisors and their subordinates
to check on employee mental and physical well-being,
we have also introduced a mentoring program toprevent employee isolation and loneliness. In addition,
we encourage our employees, who are engaged inbusiness based in the field of dementia, to conduct a
self-assessment of brain performance called NouKnow®
when they undergo their regular health checkups, as ameans of raising their own awareness of body and brain
health.

Social Value Creation(Human Capital)■Ratio of female managers ■Ratio of female employees

(%)
30

20

●Ratio of female managers

2. P reparing a suitable working environment and healthcare support to assist selfactualization (Japan)

Social Value Creation(Access to Medicines)

Fiscal 2030 goal: A ratio of female employees and managers of 30% or more; a ratio of directors in their
30s or younger of 20% or more
Progress: Ratio of female employees 26%; ratio of female managers 11.5%; ratio of directors in their 30s
or younger 14.1% (as of March, 2022)

employee to maximize their performance.
To realize the digital transformation (DX) strategy at
the core of our new business model, we are proactively
hiring data scientists, engineers, and other specialized
human talent and strengthening our human capitalbase. In addition, we will focus on developing leaders toadvance our DX.

Social Value Creation(R&D)

Ensuring diversity•F urther increase diversity in management and create an environment in which new ideas are utilized in decision-making andwhere each employee’s individuality and strengths are reflected in management and daily operations.
•E xpansion of career development programs and challenging opportunities for young employees and female employees tofoster and produce diverse leaders•P roviding information on nursery schools and other facilities for a smooth return to work when employees take childcare leave,and support for self-development during leave for those who wish to do so•E stablish opportunities for seasoned employees to demonstrate their unique abilities and create an environment that allows
them to continuously take on challenges regardless of age (career awareness seminars and training for middle and senior age
groups will be held a total of five times between January and June, 2022)• Hiring of international students began in fiscal 2013
• Conduct unbiased, fair screening of mid-career hires for advancement and promotion to management positions• Implement an annual succession planning process for key global positions to select, develop, and promote the next generationof leaders, ensuring diversity in terms of nationality, gender, age, etc.
• Improvement in the working environment for employees of diverse nationalities and religions, including by setting up a Prayer
Room in the Tokyo headquarters office

In addition, to maximize the human capital base for
executing management strategy, we are visualizing
employee engagement through people analytics, inaddition to utilizing qualitative information. Goingforward, we will conduct human capital portfolio
analysis and optimal placement analysis to implement
effective, data-driven human resource strategies and topromote providing opportunities for each individual

Management Strategies●Initiatives in Japan
Compared with other countries, Japan still faces a
number of challenges in relation to enhancement ofdiversity, including gender diversity, and there is anurgent need for multifaceted measures. As part of “Eisai

Natural Capital

Environmentally Responsible Business Activities

Target year for achieving carbon neutrality

Creating a solid foundation to ensure global environmental
sustainability and generate corporate value

To date, the Eisai Group has set a Science Based
Target (SBT) for 2.0°C＊1 for medium- and long-term
greenhouse gas emission reductions, and together wehave worked to reduce CO2 emissions. To further
accelerate these efforts, we launched a crossorganizational Carbon Neutral Project and in May 2021,
we issued our Statement of Commitment for Carbon
Neutrality by 2040, setting out a new target.
In preparing to achieve this target, we collected
information from various domestic and overseas
business sites and ENW companies on energy use and●Summary of the roadmap to carbon neutrality(Scope 1 and 2 emissions reduction plan)

Achieve carbon
neutrality

Two social goods we hope to achieve• Relieve anxiety over health• Reduce health disparities<Promotional Slogan>“Eisai Environmental Activities for Sustainable Society 2040”⇒ “Better future 2040”

41• Medium-term target: Achieving 100% usage of renewable energy by 2030
Eisai will switch over to renewable energy for all electric power, which accounts for 65.3% (as of fiscal 2019) of the totalenergy used by the entire Group (Aiming for zero CO2 emissions from the use of electric power classified in Scope 2).
• Long-term goal: Achieving carbon neutrality by 2040
Eisai will balance out CO2 emissions and absorption across the entire Group (Aiming for zero CO2 emissions from theconsumption of fossil fuels classified in Scope 1 following the achievement of the target for Scope 2).

■ Progress towards Achievement of the SBT
The Eisai Group conducts R&D and manufacturing
activities in compliance with Good Laboratory Practices(GLP), standards for conducting non-clinical trials
regarding drug safety, and Good Manufacturing
Practices (GMP), standards for drug manufacture andquality control. This requires that we operate undercertain temperature and humidity conditions, and we
consume a considerable amount of electricity byoperating air conditioners, etc.
In fiscal 2021, 65.8% of the energy used by all Eisai
companies was derived from electricity, and reducing
CO2 emissions associated with electricity use is apriority issue. Therefore, the head office, the Kawashima
Industrial Park, the Tsukuba Research Laboratories, andEisai Distribution Co., Ltd. have all switched part of theirelectric power to electricity derived from renewableenergy. Overseas, the Vizag Plant (India) procureselectricity from solar power generation, and the Exton
Site (U.S.) generates its own solar power for use on
site, while also procuring electricity derived fromrenewable energy. In addition, the European Knowledge
Centre (U.K.) is also using electricity derived fromrenewable energy, helping us to achieve 100% usage of
renewable energy at our main business sites overseas.
As a result of these efforts, Eisai’s company-wide
renewable energy adoption rate in fiscal 2021 reached63.1%, reducing CO2 emissions by 44.6% (comparedto fiscal 2016) and is expected to achieve the fiscal
2030 reduction goal set under the SBT for 2.0°C target
ahead of schedule.
Going forward, we aim to raise our fiscal 2030
reduction target to 62% (compared to fiscal 2016), and42

Eisai Value Creation Report 2022

Company Information

generation plants; AI and data-driven research; use of
web interviews in conducting activities around providing
information; and virtual clinical trials utilizing
telemedicine.
As we work toward “Better future 2040,” each
employee, as a global citizen, will work sincerely toreform our operations and act with an awareness of theenvironment, starting with issues closest to home.

The key to the Eisai Environmental Management Vision
is for each individual employee to treat environmental
protection as a personal matter, and to help advancechanges in work styles and operations. Going forward,
we will explore and put into practice businessdevelopment that differs from conventional methods.
This will include work styles built on Activity Based
Working, in which employees across all departmentschoose where and when they work; building next-• Expand deployment of renewable energy• Invest in decarbonization• Shift sales fleet to low carbon and decarbonized vehicles• Utilize new fuels such as hydrogen and others＊1 3
 0% reduction of GHG emissions (Scope 1 and 2) by fiscal 2030 (compared to fiscal 2016)＊2 3
 0% reduction of GHG emissions (emissions based on purchased products and services in
Scope 3, Category 1) by fiscal 2030 (compared to fiscal 2016)
Scope 1: Direct emissions of GHG released into the air from use of fossil fuels
Scope 2: Indirect emissions of GHG from use of electricity and steam purchased from others
Scope 3: Indirect emissions of GHG through the supply chain, excluding Eisai itself

Foundation forSocial Value Creation<Eisai Environmental Management Vision>(1) We will work sincerely to realize the Company’s two goals for social good, and at the same time to protect the
global environment as set forth in the basic policy and action guidelines of the ENW (Eisai Network Companies)
Environmental Policy.
(2) We will become a leader in environmental protection activities, clearly demonstrating our significance to society.
(3) As leaders in environmental protection activities, each of us will pursue the most efficient ways of achieving social
good by changing the way we work and the structure of our business.
(4) We will contribute to society’s sustainability through our environmental protection efforts, which will also lead toincreased non-financial value.

2040 (fiscal year)<Key measures>Social Value Creation(Human Capital)

Achieving social good and global environmental protection is our responsibility as an hhc company

2030

0

Social Value Creation(Access to Medicines)

Reduce CO2
emissionsby 62%

2016 (base year)

Global environmental protection we hope to achieve• Prevent climate change due to global warming• Prevent marine pollution from marine plastics and other sources• Maintaining ecosystems• Securing water resources, etc.

Plan to reach our target for
RE100 ahead of schedulein fiscal 2023

capital investment plans as well as CO2 reduction
measures for the next 10 years. Based on progress in
CO2 reduction technologies and investment potential,
we created a road map to fiscal 2040. This roadmap
will be reviewed each year according to our progressand changes in the external environment.
Going forward, in addition to continuing energysaving activities, we will continue investing in
decarbonization, expand deployment of renewableenergy, shift our sales fleet to low-carbon or
decarbonized vehicles, proactively introduce advanced
technologies, and utilize hydrogen and other new fuels,among other steps. Note that in terms of investments,
we have just introduced Internal Carbon Pricing (ICP),
which promotes effective investment in CO2 emission
reductions by converting those reductions intomonetary amounts and visualizing them, thenincorporating them into an investment decision criterionas the amount of the investment effect. We will also
strengthen our efforts to reduce greenhouse gas
emissions＊2 in our supply chain in cooperation with ourbusiness partners.

Social Value Creation(R&D)

The Eisai Group has established the ENW (Eisai
Network Companies) Environmental Policy and theentire company has been working together onenvironmental protection. And now, because it is our
responsibility as an hhc company to simultaneously
address social good and environmental protection, we
have established the Eisai Environmental Management
Vision. Based on this Vision, in addition to climatechange countermeasures aimed at achieving carbon
neutrality by fiscal 2040, we have formed a medium- tolong-term plan for environmental issues including
efficient use of water, recycling of resources,
preservation of biodiversity, and proper management ofchemical substances, and will work to further advancethese efforts.

As a human health care (hhc) company, the Eisai Groupnot only delivers pharmaceutical products to patientsand to people in the daily living domain, but offers
solutions tailored to diverse needs. Our goal in doing so
is to accomplish two social goods: relieving anxiety overhealth, and reducing health disparities.
We view the global environment as the foundation ofbusiness activities aimed at achieving social good.
There is a relationship between the global environment
and people’s health. Climate change, for example, isalready causing adverse effects such as an increase ininfectious disease, and in the future is expected toincrease the number of deaths from malaria, heatstroke, and other causes. This is why we recognize theextremely high importance of environmental protection
as the Group aims to relieve anxiety over health.

■ Climate Change Countermeasures: Initiatives to Reduce Greenhouse Gas Emissions
Management Strategies

2040

Social and Relationship Capital●Progress in SBT
Scope (1+2) CO 2 emission results＊

Social and Relationship Capital

Resolution for fiscal■ Plan134,547 133,282 133,128 132,017 133,368 130,752

120,000

129,487■ Result-B uild a foundation for corporate responsibility to respect human rights inaccordance with the Guiding Principles on Business and Human Rights- Implement sustainable procurement for suppliers at all of our overseas factories■ Respect for Human Rights
Eisai believes that human rights constitute the most universal and fundamental requirement for our businessactivities, and we have clearly stipulated respect for human rights as one of our standards in the Eisai Network
Companies (ENW) Charter of Business Conduct. We formulated the ENW Human Rights Policy in March 2019 andcontinue to promote efforts to respect all stakeholders’ human rights.

63.1

125,956

Primary Issues

26.8

Employees＊2• Prevention of harassment• Improving internal engagement• Acceleration of health maintenanceand improvement activities• Labor-management relations

Business partners• Respect for human rights andimprovement of the working
environment in the supply chain＊425
40,000

2017

2018

2019

2020

2021 (fiscal year)＊ Historical data was revised by recalculation.

0

0.6

0.6

2016

2017

4.8
2018

2019

2020

2021 (fiscal year)

Actions– Participation in the World Health Organization (WHO)-led global program to control lymphatic filariasis (LF), improving access to medicines
for treatment and prevention of infection for people in low-income countries and regions by providing LF treatment free of charge– Supplying personal protective equipment for infection control, etc. for continuation of LF elimination activities in endemic countries
that were delayed by the COVID-19 pandemic.
– Promoting research and development on new treatments for neglected tropical diseases, malaria, and other infectious diseases
prevalent in impoverished areas.
– Disseminating information through compliance training＊3, etc.
– Promoting dialogue within the organization and visualization of activities using engagement survey tools.
– Promoting health literacy measures based on the Eisai Health Declaration, such as 100% participation in health checkups, nosmoking across all sites, and webinars by industrial physicians.
– Continued holding of labor-management consultations (15 times in fiscal 2021)– Sharing issues regarding the medium-term business environment and promoting various work environment improvements.
– Conducting interviews with business partners (2 companies) that were determined to be high-risk based on their human rights
and labor evaluation scores using the EcoVadis platform＊5.
– Commencement of a traceability study of carnauba wax, used by Eisai as a coating for tablets, to evaluate the working
environment at the point of origin.

＊1 Please refer to pages 31-35 ＊2 Please refer to pages 36-40 ＊3 Please refer to pages 53-55 ＊4 Please refer to page 27＊5 Global platform to provide enterprises with accountability assessments by EcoVadis SAS (France)

Social Value Creation(Access to Medicines)

74,501

Stakeholders

Patients and thepeople in the daily • Improving access to medicines＊1
living domain

52.9
50

79,10980,000●Human Rights Initiatives in Relation to Major Stakeholders(%)
75

105,286

2016

2025

Adoption of renewable energy＊（t）160,000

0

Taking Human Rights and Sustainable Procurement
into Account in Our Business Activities

Social Value Creation
(R&D)

＊3 C
 DP is an NGO established in London in 2000. On behalf of institutional investors with asmuch as 96 trillion USD under management, CDP sends questionnaires to top global firms,
analyzes and assesses the responses, and provides the information to investors, governments,
and companies. Information from CDP is a powerful decision-making tool for institutional
investors in considering ESG investments.

Human CapitalManagement Strategies

their businesses from renewable energy.
The results of these efforts were certified as “A-” inthe CDP＊3 Climate Change 2021 Questionnaire. In
addition, the Company has received external
recognition, including selection for the second
consecutive year as one of the “Carbon Clean 200,” aranking of the world’s top 200 listed companies
contributing to a reduction in fossil fuel consumption,and inclusion in the S&P/JPX Carbon Efficient Index.

to obtain certification in fiscal 2023 to update ourgreenhouse gas emission reduction target to the SBT
for 1.5°C target.
Note that in December 2020, Eisai joined the Japan
Climate Initiative, a network of companies, local
governments, NGOs, and others actively working toaddress climate change, and joined more than 600
companies, local governments, NPOs, and others incalling for the realization of a decarbonized society. In
September 2021, we also became an official memberof RE100, an international initiative aimed at seeing
companies obtain 100% of the electricity they use in＊ Historical data was revised by recalculation.

●Efforts to Raise Awareness of Human Rights

to business, etc. and the Corporate Officer in charge ofEnvironmental and Safety Affairs regularly reports to the
Risk Management Committee regarding the status ofthese risks, thereby integrating climate-related risks into
the company-wide risk management system. As part ofpreparing for more serious natural disasters associatedwith climate change, the Kawashima Industrial Park
plans to reduce the risk of flooding of up to 1.4 meters
by installing flood barriers in underground conveyancechannels.
＊4 T ask Force on Climate-related Financial Disclosures (TCFD): A working group of the Financial
Stability Board (FSB), consisting of central bank governors and finance ministers. This is a
private sector-led task force that encourages companies and others to efficiently disclose
climate-related financial information in order to encourage investors and others to makeappropriate investment decisions.

■ Initiatives Aimed at Sustainable Use of Water Resources

For further information regarding environmental protection activities, please refer to the Environmental Report.
Eisai Environmental Report: ▶ https://www.eisai.com/ir/library/annual/index.html

43■ Sustainable Procurement
Companies are expected to conduct business responsibly
while considering social and environmental issues
throughout the value chain. To realize this goal, we promotesustainable procurement to educate and improve ourbusiness partners’ awareness of human rights, labor, healthand safety, the environment, ethics, and other sustainability
issues. Specifically, we are working to improve sustainability
by explaining our initiatives through briefings, requesting
written agreement from our business partners to abide by
the Code of Conduct for Business Partners, which outlines
the standard of behavior we expect them to follow,
encouraging partners to conduct EcoVadis sustainability
evaluation, and engagement with business partners leading
to improvement based on the results.
Sustainability evaluation using the EcoVadis platform,
from a risk management perspective, has mainly been
conducted on direct material suppliers (primary directmaterial suppliers and secondary manufacturing suppliers

when the primary suppliers are wholesalers or trading
companies) for domestic factories, including contract
manufacturers.
In fiscal 2021, we evaluated a total of 107 domestic andoverseas companies, and held two briefings for domestic
business partners. The coverage rate for target companies
reached more than 98%, based on transaction volume, by
fiscal 2021. In fiscal 2022, we will promote responsible
procurement by expanding business partner sustainability
evaluation to suppliers for our overseas manufacturing sites.
●Supplier Evaluation Results
Fiscal 2020
Companies evaluatedCompanies who submitted writtenagreement for the Code of Conduct
Companies assessed by EcoVadis
Sustainability Evaluation
Companies engaged through online
interviews

44

Fiscal 2021

44

107
(of which overseas: 18)

43

93(of which overseas: 14)

34

64(of which overseas: 11)12

11

Eisai Value Creation Report 2022

Company Information

We have set medium- to long-term goals to achievesustainable use of water resources, including recycling,
and continue high-quality wastewater treatment that
contributes to water quality preservation. We will monitor
progress toward these goals based on quantitative
indicators. Note that our efforts have been certified as“A-” in the CDP Water Security 2021 Questionnaire.

In April 2021, the ENW Environmental Policy was revised
to clearly state that one of our environmental action
guidelines is to contribute to the formation of a recyclingoriented society through the sustainable use ofresources, including water. In the past, we have also
been working to ensure the quality of water discharged
from our plants and laboratories, and to promote theefficient use of water resources in Japan and overseas.

human rights risk cases, understanding and implementing
the ENW Human Rights Policy, and discrimination issues.
In addition, with the aim of “sharing the thoughts,
concerns, and feelings of LGBT people,” lectures were
held at which external LGBT speakers were invited to
speak, and these were attended by 4,839 participants.

Foundation forSocial Value Creation

In June 2019, we endorsed the Task Force on Climaterelated Financial Disclosures (TCFD)＊4 and beganpromoting disclosures based on the framework thefollowing year, conducting a pilot climate scenario
analysis. (For further details regarding the scenario
analysis, please refer to pages 62-63 of the Integrated
Report 2020. https://www.eisai.com/ir/library/annual/
pdf/epdf2020ir.pdf)
At Eisai, the Risk Management Committee, chairedby the Corporate Officer in charge of Internal Control,
manages important business risks, including climaterelated risks, and reports to the Board of Directors.
Climate change is regarded at the Company as a risk

To ensure that our business activities are based on respectfor human rights, we continue to conduct human rights
awareness programs for corporate officers and employees
of our company and domestic network companies. In
fiscal 2021, human rights awareness trainings wereconducted online with 5,071 participants, covering global

Social Value Creation(Human Capital)■ Use of the TCFD Framework: Initiatives to Address Climate-related Risks

Corporate GovernanceRatio of outside directors on the board of directors

Striving continually to achieve the best corporate governancediversity over the medium to long term. This includes not
only diversity in terms of nationality, gender, and age, butalso diversity in terms of professional expertise, fromthose experienced in corporate management and global
business to experts in law and financial accounting.
As of July 1, 2022

Corporate
management

GlobalHaruo Naito

◦

◦

74

Yasuhiko Katoh

◦

◦

75

Name

 eatures of Eisai’s Corporate Governance■F●Corporate Governance System (As of July 1, 2022)

Board of Directors (11 members: 7 outside, 4 inside; Chair: outside director)

Chair

Shuzo Kaihori◦◦

Hideyo Uchiyama◦◦

Hideki Hayashi◦◦

Shuzo Kaihori

Hideyo Uchiyama

Yumiko Miwa

Fumihiko Ike

Ryota Miura

Richard Thornley

Haruo Naito

Outside Director

Fumihiko Ike◦◦

Hiroyuki Kato

Yoshiteru Kato◦◦

hhc GovernanceCommittee

Hiroyuki Kato◦◦

Richard Thornley◦◦

Yoshiteru Kato

Inside Director

Nomination
Committee(3 members: all outside)
Chair: Shuzo Kaihori

Compensation
Committee(3 members: all outside)
Chair: Fumihiko Ike

Board of Directors Secretariat

Representative Corporate Officer and CEO
Corporate officers
Individual divisions/
Subsidiaries inside and outside Japan
Development and operation of the internal control system

64
◦

◦

(ESG, Corporate Governance)(Female)

◦

56
70
62

◦

48
64
◦
(Foreign Nationality)

57

The mark ◎ indicates the primary reason the Committee selected the director.

 ystem of Operational Divisions for Flexible, Optimal Decision-Making and Business Execution❸S
Officers.” The corporate officers implement, maintain,a. Selection and Assignment of Corporate Officers
and operate internal control systems in their assigned
The Board of Directors selects corporate officers who
duties in accordance with the Rules. Eisai also assigns
will be responsible for realizing the corporate concept
global corporate officers, with the corporate officers
and enhancing corporate value from a global
who are in charge directly building and operating
perspective and positions them so that they caninternal control systems at overseas subsidiaries.
effectively and efficiently demonstrate their capabilities.
People who are well-versed in the operations in eachc. Instilling Management with Accountability and Stakeholder
field of administration, including those with advanced
Consciousness
expertise in R&D, science, and the production, quality,
Once every 3 months, all corporate officers attend aand other aspects of pharmaceuticals, as well as those
Board of Directors meeting and report to the Board ofwith extensive knowledge in the medical systems andDirectors on decisions made in operational divisions, as
health care markets in particular regions of the world,well as the status of their business execution. Corporate
are selected as corporate officers.
officers having accountability and reporting to the Boardof Directors improves the rationality and transparency ofb. Building and Operating a Global Internal Control Systemdecision-making, policies, and initiatives of operational
The Board of Directors has established the “Rules fordivisions, while instilling stakeholder consciousness in
Preparing Necessary Systems for Ensuring themanagement.
Suitability in the Performance of Duties by Corporate

appropriateness and efficiency of management.
The Board of Directors also delegates importantmanagement oversight functions of the Board of Directors
to the Nomination Committee, Audit Committee andCompensation Committee, and oversees the execution of
the duties of these committees based on their respective
reports. The fairness and transparency of the Board of
Directors are also ensured through oversight of eachindividual director to verify whether they are making fairjudgments, exercising their authority in a way that satisfies
the confidence placed in them by all shareholders, andexecuting their business functions appropriately.

46

Eisai Value Creation Report 2022

Company Information

 anagement Oversight by the Board of Directors❹M
The Board of Directors delegates a large portion of thedecision-making authority over business execution tocorporate officers, and corporate officers are
responsible for reporting to the Board of Directors in atimely and appropriate fashion.
The Board of Directors has the authority to selectand dismiss corporate officers, and confides incorporate officers by verifying the appropriateness andefficiency of business execution processes based on
their reports while also evaluating the performance
results of the business execution, thus fulfilling the roleof management oversight by ensuring theFoundation forSocial Value Creation

 lear Separation of the Functions between Oversight of Management and the Execution of Business❶Con rules related to “systems for ensuring proper
Eisai fully leverages its system of being a company withbusiness operations,” and establishes the specific rules
a nomination committee, etc., with the Board offor internal controls that should be put in place andDirectors entrusting a large portion of the decisionimplemented by corporate officers, in accordance withmaking authority over business execution to corporate
the stipulations of the Companies Act. In addition to theofficers, to the extent permitted by laws and regulations,matters stipulated in those rules, corporate officers
in order to devote its attention to the oversight ofensure autonomy by establishing and operating internalmanagement.
controls in their assigned duties, thereby increasing theThis enables prompt, flexible decision-making andspeed and flexibility of business execution.
business execution by corporate officers even in
Under this structure, the Board of Directors also
environments that are undergoing turbulent changes.
checks the status of execution of duties by corporate
Additionally, in order to achieve a clear separation
officers, and examines the appropriateness of the
between the oversight of management and thestatus of internal controls such as the businessexecution of business, Eisai has established a practiceexecution and decision-making processes from theof having the chair of the Board of Directors be an
perspective of shareholders and society.
outside director, and of the Representative Corporate
Directors and corporate officers communicate with
Officer and CEO being the only individual toeach other and build trust when carrying out theirconcurrently serve as a corporate officer and a director.
respective duties and fulfilling their responsibilities,
Clearly separating the oversight of management andworking together to increase corporate value andthe execution of business enhances corporate vitality.
contribute to the creation of social value. Mechanisms
The Board of Directors exercises the function ofsuch as these are the characteristics of good corporate
oversight from the perspective of stakeholders togovernance.
ensure fairness and transparency in management.
Meanwhile, the Board of Directors passes resolutions

45

69

Social Value Creation(Human Capital)

Internal Audit

Corporate officer responsiblefor internal control
Corporate Internal Audit Department

74

Ryota Miura(7 members: all outside)
Chair: Yasuhiko Katoh

AgeSocial Value Creation(Access to Medicines)

Management oversightOperational
division

Appropriate reportingand proposals

Monitoring/verification

ReportAccounting
AuditorManagement
Audit Department

Audit by Committee

Audit Committee(5 members: 3 outside, 2 inside)
Chair: Hideyo Uchiyama

Hideki Hayashi

Gender &nationality◦◦

Yumiko Miwa

Yasuhiko Katoh

Legal

Social Value Creation(R&D)

General Meeting of Shareholders

Finance &accounting

Academic
background(discipline)

Management Strategies

63.6%

 iversity of Directors❷D
Eisai selects directors with diverse backgrounds sothat the Board of Directors can meet the expectationsof stakeholders and fulfill its management oversightfunction.
For outside directors in particular, we aim to ensure❶ The Chair of the Board of Directors is appointed from among outside directors.
❷ The Chair of the Board of Directors proposes the Board of Directors agenda items
for the year, annual themes, etc.
❸ A week before meetings of the Board of Directors, there is a meeting with thesecretariat and Head Office staff regarding the content of agenda items, materials, etc.
❹ The Chair of the Board of Directors draws out knowledge from directors withdiverse backgrounds, enhances the quality of the discussions among members of
the Board of Directors, and manages Board meetings effectively and efficiently.

❶ The Nomination Committee consists of outside directors.
❷ Information on candidates is also collected from members of the Nomination
Committee and all other directors and former outside directors of the Company.
❸ Candidates are narrowed down after screening for independence and presence ofany competitive activities, etc.
❹ After the order of priority of requests for appointment has been set, the Chair of
the Nomination Committee (outside director) submits assignment requests to thecandidates.

Chair of the Board of Directors(Outside Director)

Corporate Governance Evaluation

hhc Governance Committee

For the Basic Approach to Corporate Governance and Activities of the Board of Directors and Committees such as an hhc Governance Committee,
please refer to pages 56-78 of the Notice of Convocation of the 110th Ordinary General Meeting of Shareholders▶ https://www.eisai.com/ir/stock/meeting/pdf/einv110_all.pdf

 haring of Information Related to Efforts toward Sustainability■S“Corporate Governance Principles,” the Board of
Directors receives reports from the assigned corporate
officers regarding individual themes, in addition toregular reports related to ESG, and monitors the efforts.

47

 ialogues with Institutional Investors❷D
Various dialogues have been held with investors,
including lectures, one-on-one meetings, andexchanges of opinions.
• Institutional investors (analysts) were invited to givelectures on “What I want to tell outside directors as an
institutional investor,” followed by a question-andanswer session and an exchange of opinions.
• An opinion exchange session was held withapproximately 70 institutional investors and others
through an online conferencing system, featuring
roughly two hours of questions and answers, as well
as discussions.
• Individual dialogues with institutional investors were held
via online and telephone conferencing. Eleven of thesesessions were held, sharing information and exchanging
opinions with around eight companies in total.
 ialogues with Employees❸D
Dialogues were held (February 2022) with labor union
representatives who participated on behalf of
employees, and information related to the following
matters was shared.
•F ostering job satisfaction among employees andproviding opportunities to develop skills•S upporting the good health of employees andmanaging safety and health•P romoting diversity•C orporate culture• The impact of implementing voluntary early retirement
3 years in a row•R equests to executives related to diversity andpromotion of the active participation of women• The degree of permeation of the EWAY Future &Beyond medium-term business plan among
employees

Exchange of opinions with institutional investors and others held using an online conferencing system

Dialogue held with labor union members online

48

Eisai Value Creation Report 2022

Company Information

In order to enhance the Board of Directors’ discussions regarding sustainability, the hhc Governance Committee
shared and discussed information on the following themes in fiscal 2021.
• The background leading to the production of the “Value Creation Report,” which was revamped with a new focus
around the theme of “sustained corporate growth through the enhancement of nonfinancial capital,” and changes
in the ESG-related environment• The current status of and issues relating to the promotion of the active participation of women based on “Eisai
Diversity & Inclusion 2021”• The international situation related to expectations of companies regarding human rights, and the structure of the“Business and Human Rights” project, a human rights due diligence plan directed at the supply chain•C onsideration and implementation of sustainability strategy and tactics to address the results of evaluation of theCompany by the Dow Jones Sustainability Index (an outside evaluation related to ESG) and the results of outside
evaluation•R eports on the progress of activities aimed at eradicating neglected tropical diseases (NTDs)

Participation in dialogue with patients that was organized internallyFoundation forSocial Value Creation

In addition to being a key management issue, efforts
toward sustainability constitute a risk that could affectcorporate value. In accordance with Article 9 (Working
on Realization of a Sustainable Society) of the ialogues with Patients❶D
Talking with early-onset dementia patients, and learning
about the way they face the disease and the sternrealities of the impact of dementia on their lives,
provided a renewed recognition of the Company’ssocial mission. Such dialogue provided a deeper
understanding of the importance of empathy with thepatient’s emotions, as well as the hhc Corporate
Concept and its practical application.

Social Value Creation(Human Capital)❶ Matters are discussed freely, with only outside directors in attendance.
❷ There is proactive dialogue with stakeholders❸ Information regarding the succession plan proposed by the CEO is shared anddiscussed.
❹ Corporate governance evaluations (including the evaluations made by eachdirector) are summarized and proposed to the Board of Directors.
❺ As necessary, the Board of Directors and corporate officers are asked to consider
issues, share information, etc.

❶ Review of Corporate Governance Principles and internal control-related rules.
❷ The hhc Governance Committee compiles the results of evaluations of eachdirector and makes proposals to the Board of Directors, including issues.
❸ Resolutions are passed by the Board of Directors and disclosed in business
reports, etc.
❹ The PDCA cycle is driven by confirming the implementation status of issues at
Board meetings, etc.
❺ Reviews of Board of Directors evaluations are conducted by an outsideorganization once every 3 years.

perspectives. In fiscal 2021, the hhc GovernanceCommittee reviewed these dialogues and held
discussions on how to utilize the key points andknowledge gained from these dialogues in the
supervisory function of the Board of Directors.

Social Value Creation(Access to Medicines)

System for Selecting
Outside Directors

The Company has engaged in dialogue with patientsand the general public, shareholders and institutional
investors, and employees, who together constituteEisai’s main stakeholders, as outlined below. In
dialogues between outside directors and stakeholders,
we exchanged in-depth opinions from a variety ofSocial Value Creation(R&D)●A Sustained, Autonomous Mechanism for Enhancement of Corporate Governance Centered on Outside Directors

 ialogues with Stakeholders■D
Management Strategies❺ A Sustained, Autonomous Mechanism for Enhancement of Corporate Governance Centered on Outside Directors
Committee, (2) operating the Board of Directors, etc.,
The presence of independent outside directors, who
through the leadership of a chair who is an outsideaccount for a majority of the members of the Board of
director, (3) an hhc Governance Committee for broad
Directors, supports the effectiveness of the corporate
discussion of corporate governance, including dialogues
governance structure. As indicated in the diagramwith stakeholders and the consideration of succession
below, Eisai has established and is operating aplans, etc., and (4) corporate governance evaluations
mechanism to enhance sustained, autonomous
through the Plan-Do-Check-Act (PDCA) cycles of thecorporate governance centered on outside directors,
Board of Directors and each committee. We will continue
including (1) a system of electing neutral andto work to enhance the content of each of these efforts.
independent outside directors by a Nomination

■ Information Sharing and Discussion Regarding the Succession Planfor such unexpected situations are also confirmed when
considering the succession plan.

 echanism for Utilizing Outside Organizations to Improve and Ensure the Appropriateness of■M
the Evaluation of the Board of Directors
The Company has implemented a mechanism in which
an outside organization examines the evaluation process,evaluates it, proposes improvements, and inspects the

hhc Governance Committee

Outside Organization①

Proposals for systemrevisions, etc.

②Consideration of revising theBoard of Directors evaluation system

Analysis, etc., of past corporate
governance evaluations

Implementation

Calculation

Share results of calculation❷ Compensation System for Corporate Officers
Compensation paid to corporate officers is determinedin accordance with basic policies by the Compensation
Committee with the aim of enabling Eisai to attract
excellent personnel to its management cadre and tostrongly motivate corporate officers in the performanceof their duties, thereby making a substantial positive
contribution to Eisai, and with a recognition of thedifferences in the levels and mechanisms ofcompensation, etc., in each country or region.
The level of compensation paid to corporate officers
is intended to be set in the upper-middle range for theindustry. The compensation paid to corporate officers is
composed of base compensation, bonuses, and stockbased compensation at a ratio of 6:3:1, andperformance-based compensation accounts for 40% of
total compensation.
Stock-based compensation provided to corporate
officers increases or decreases each year according toEisai-wide performance. In addition, in the medium andlong term, when stock prices fluctuate, the actual valueof the compensation fluctuates accordingly. Eisai
believes that maintaining this mechanism will strengthen
the motivation of corporate officers to adopt theperspective of shareholders and strive to increase
corporate value.
We aim to incorporate ESG and other non-financial key
performance indicators (KPI) into those used to determine
performance-based compensation in fiscal 2022.

Deliberation/
consideration

Compilation of corporate
governance evaluations
Evaluation results,
proposal of issues, etc.

＝

Base amount of bonus

×

Payout rate: 0% to 225%
Sit in on the
hhc GovernanceCommittee meeting③

Inspection/analysis of theevaluation process and compiled results

Analysis of theevaluation process
and evaluation results

Evaluation report (Results of verification related to the appropriateness of the evaluation process and evaluation results)

49

Bonuses

Stock-based
compensation ＝ Number of shares granted
Payout rate: 0% to 150%

Degree of attainment ofCompany-wide
performance objectives＊

×

Evaluation: 0% to 150%

×Degree of attainment of
individual performance
objectives
Evaluation: 0% to 150%

Degree of attainment ofCompany-wide
performance objectives＊
Evaluation: 0% to 150%

＊Calculated in accordance with the degree of achievement of the targets for consolidated revenue, consolidated operating profit, consolidated profit for the year
(attributable to the parent company), and consolidated ROE.

For the Total Amount of Compensation Paid to Directors and Corporate Officers and Total Amount of Consolidated Compensation for Each Officer (¥100 million ormore), please refer to pages 79-82 of the Notice of Convocation of the 110th Ordinary General Meeting of Shareholders▶ https://www.eisai.com/ir/stock/meeting/pdf/einv110_all.pdf

50

Eisai Value Creation Report 2022

Company Information

Review of Corporate Governance Principles
and regulations related to internal control

Determination of corporate
governance evaluation

used to ensure that directors are able to properly
perform their oversight functions. The level ofcompensation is intended to be set in the upper-middle
range for the industry.

●Process of Determining Performance-based Compensation

Board of Directors evaluation④❶ Determination of Compensation, etc.
Compensation paid to directors consists only of fixedbase compensation. The duty of directors is tosupervise management, and a fixed rate notincorporating performance-based compensation is

Report (advice, etc.)

Decision to revise the Board of
Directors evaluation system
Evaluation by each director■ Compensation Paid to Directors and Corporate Officers

Foundation forSocial Value Creation

Board of Directors

evaluation results, etc., once every 3 years, with the aimof ensuring the appropriateness of the evaluation of theBoard of Directors and improving the evaluation.

Fiscal 2021 Corporate Governance Evaluation Results
In regard to the Corporate Governance Principles and Internal Control Regulations, no evidence was found of any
operation, etc., that deviates from the rules. It was confirmed that the directors and corporate officers, etc., areexecuting their duties appropriately in such a way as to improve corporate governance.
In regard to evaluation of the Board of Directors, the state of response in fiscal 2021 to the issues identified in thefiscal 2020 Board of Directors evaluation as issues for fiscal 2021 was checked and evaluated, and the issues, etc.,
for the next fiscal year were recognized. More information on the evaluation of the Board of Directors is available in theOnline Disclosures (https://www.eisai.com/ir/stock/meeting/pdf/einv110_all.pdf).

Social Value Creation(Human Capital) reparations for Unexpected Situations❸P
Circumstances, such as unforeseen accidents, thatnecessitate the sudden selection of a new CEO by the
Board of Directors are also possible. Contingency plans＊The next review by an outside organization is scheduled for fiscal 2023

Social Value Creation(Access to Medicines)

Committee twice each year.
② The CEO and inside directors also participate in the
hhc Governance Committee, and information on the
succession plan is shared among all directors.
2) Discussion regarding the Succession Plan
①C
 riteria for evaluating candidates are expected tochange in accordance with the businessenvironment and other factors. For this reason,
criteria will be set appropriately when the CEO
proposes candidates.
② The CEO evaluates candidates based on the criteriathat have been set, and presents evaluation resultsin the succession plan.
③D irectors provide advice on the succession plan. The
CEO considers the advice provided by the directors,
and reflects it in the succession plan as appropriate.

Social Value Creation(R&D)

 rocedures Regarding CEO Selection❷P
Even after becoming a company with a nominationcommittee, etc., system in 2004, there had been
repeated discussions under a consistently optimal
corporate governance system regarding the CEO
succession process. In fiscal 2016, with consideration
given to developments up to that point, discussions
were held in the Outside Directors Meeting (now the
hhc Governance Committee) on how information
should be shared by the Board of Directors in relation toa succession plan formulated by the CEO, and how to
prepare for unexpected situations. These procedures,and other considerations, were set out as rules. The
outline of the procedures is as follows.
1) Sharing of Information about the Succession Plan
① Information about the succession plan proposed by
the CEO is shared at meetings of the hhc GovernanceManagement Strategies❶ Views Regarding Selection of the Chief Executive Officer (CEO)participation of outside directors to provide advice, etc.,
The Company considers the selection of the CEO asenhances the objectivity of the thinking regarding theone of the most important decisions to be made by theCEO’s proposed successor candidates. It enables
Board of Directors. The CEO’s duty is to exhibit strong
reasonable assurance of the fairness of the CEO
leadership while also nurturing the next CEO. Based on
selection process by the board of directors.
this recognition, the Company believes that the① After analyzing the Company’s past evaluation methods, evaluation decision process, evaluations of each director,
and final evaluation, etc., the outside organization points out issues and makes recommendations regarding thesystems and their operation.
②B
 ased on the recommendations and what was pointed out by the outside organization, the hhc GovernanceCommittee and Board of Directors work on improving the systems and their operations.
③ The outside organization inspects the evaluation process, evaluation results, and other aspects of the Board of
Directors evaluation compiled by the hhc Governance Committee, and submits a report to the Board of Directors.
④ The Board of Directors decides on the corporate governance evaluation for the applicable fiscal year based on theevaluation compiled by the hhc Governance Committee and the report by the outside organization.

Interview with an Outside Director

Corporate Executives (As of July 1, 2022)

Outside Director

Q: Please share your thoughts on the past year,
including how you handled yourself after being
appointed as a Director who oversees
management, and what you have reflected on.
A: Eisai is a company with a nomination committee,etc., system, and the Board of Directors is dedicatedto supervising management, with executive officers
being responsible for making business execution
decisions. While there are occasions when judgments
based on a high degree of expertise are required in the
global expansion of drug development, the Board of
Directors appropriately appoints and assigns executive
officers to ensure appropriateness and efficiency inbusiness execution. The Board of Directors supervises＊Outside Directors

Directors

Haruo Naito

Yasuhiko Katoh＊

Shuzo Kaihori＊

Director
Representative Corporate Officer and CEO

Chair of the Board of Directors
Chair of the hhc Governance Committee

Director
Chair of the Nomination Committee
Member of the Compensation Committee
Member of the hhc Governance Committee

Hideyo Uchiyama＊

Hideki Hayashi

Yumiko Miwa＊

Director
Chair of the Audit Committee
Member of the hhc Governance Committee

Director
Member of the Audit Committee

Director
Member of the Audit Committee
Member of the hhc Governance Committee

Fumihiko Ike＊

Yoshiteru Kato

Ryota Miura＊

Director
Member of the Nomination Committee
Chair of the Compensation Committee
Member of the hhc Governance Committee

Director
Member of the Audit Committee

Director
Member of the Audit Committee
Member of the hhc Governance Committee

Hiroyuki Kato

Richard Thornley＊Director

Director
Member of the Nomination Committee
Member of the Compensation Committee
Member of the hhc Governance Committee

The order is from top left to right in the order of appointment.

Corporate Officers

Haruo Naito

Yasushi Okada

Kenta Takahashi

Representative Corporate Officer
CEO

Representative Corporate Officer
COO

Executive Vice President
General Counsel

Gary Hendler

Terushige Iike

Senior Vice President
President, EMEA Region

Senior Vice President
President, Eisai Japan

Senior Vice President
Global Alzheimer’s Disease Officer
President, Americas region

Yanhui Feng

Masatomi Akana

Senior Vice President
President, China region

Senior Vice President
Chief Government Relations Officer

Senior Vice President
CFO
Chief IR Officer

Senior Vice President
Chief Scientific Officer

Vice President
Chief Clinical Officer, Alzheimer’s Disease

Vice President
Corporate Communications
ESG

Shohei Kanazawa

Akiko Nakahama

Vice President
President, Asia and Latin America Region

Vice President
Chief Portfolio Officer

Yosuke Akita

Keisuke Naito

Eriko Naito

Vice President
Chief Compliance Officer

Vice President
Chief Ecosystem Officer

Vice President
President, Consumer hhc Business Division

proposal to the Board of Directors on April 27, 2022.

Kazuhiko Tamura

Teruyuki Masaka

Mitsuo Kosaka

Vice President
President, Eisai Demand Chain Systems

Vice President
Chief HR Officer

Vice President
Chief Strategy Officer

51

Shin Ujiie

Company Information

Q: What are your roles as an outside director andyour thoughts on the future?
A: This year is very important for us. At a time like this,I would like to create an environment in which
management takes appropriate risks by making themost of my knowledge of corporate legal affairs,
including corporate governance, and I would also liketo contribute toward improving corporate value, basedon the Corporate Concept of human health care.

Foundation forSocial Value Creation

Lynn Kramer

Vice President
General Affairs
Environmental and Safety Affairs

Ryota Miura

Sayoko Sasaki

Takashi Owa

Masayuki Miyajima

Outside Director

Ivan Cheung
Social Value Creation(Human Capital)

Tatsuyuki Yasuno

Q: What is the background to the discontinuing
and abolition of the Policy for Protection of theCompany’s Corporate Value and Common
Interest of Shareholders (“the Policy”)?
A: Since the Policy was first adopted on February 28,
2006, we have continued to implement it while
reviewing and revising the effective period and theapplicable acquisition criteria in light of the exchange of
opinions with institutional investors. However, many
institutional investors have exercised their voting rights
in opposition to the proposal for the election of directors
at the Ordinary General Meeting of Shareholders,
because we have this Policy, despite the fact that theyhold the Company’s management philosophy andcorporate governance in high regard. Moreover, if we
consider recent trends related to takeover defense
measures, we can see that the need to establish
measures, such as the Policy, in advance, hasdecreased. Because of these circumstances, theIndependent Committee of Outside Directors
considered options including the maintenance, abolition,and revision of the Policy in fiscal 2021, and decided torecommend discontinuation (abolition) of the Policy in a

The hhc governance committee is composed of all outside
directors.

Social Value Creation(Access to Medicines)

Q: What are your roles as an outside director andyour thoughts on the future?
A: I am currently appointed as an outside director of
two other companies besides Eisai, and one of theimportant roles expected of outside directors is toproperly communicate with the executive side about
the expectations, concerns and issues identified
through engagement with various stakeholders.
Moreover, I think it is important for employees to be
candid about what they are reluctant to say directly to
management, in order to improve the effectiveness ofthe governance of the Board of Directors.
This is a challenging year for Eisai and we will be
required to steer the company in a tough direction, but
I am determined to fulfill my mission as a director to
return Eisai to a growth trajectory in fiscal 2022 andbeyond.

Fumihiko Ike: Female)Social Value Creation(R&D)

management by receiving sufficient reports fromexecutive officers, including reports on important issues,
on a regular basis. With the adoption of a monitoringmodel for the Board of Directors in this way, I think thatthe corporate governance system is firmly established.
In the future, I would like to further ensure the fairness,transparency, and objectivity of management in theoperation of the Board of Directors.

: Foreign nationality,

Management Strategies(

Vice President
Chief Planning Officer

For descriptions of official positions, please refer to Eisai’s Corporate Website.
▶ https://www.eisai.com/company/profile/officer/index.html

52

Eisai Value Creation Report 2022

Compliance, Risk Management, and Internal Audit

Yosuke Akita
Vice President
Chief Compliance Officer (CCO),
Internal Control and Chief
Information Security Officer sinceJune 2022●Relationship between law and compliance

Compliance

Law

Expectations
from people

54

Eisai Value Creation Report 2022

Company Information

Nakajima: Eisai clearly has a corporate concept of
hhc. What I found wonderful was that Eisai’s Articles ofIncorporation clearly mention the corporate concept of
hhc as well as observance of laws and ethics. Very few
companies in Japan have a corporate concept in their
Articles of Incorporation, and this is epoch-making. I
think the Articles of Incorporation are a commitmentthat a company makes with its shareholders and withsociety in general. I am very impressed by Eisai’s
inclusion of its corporate concept. Society is changing.
Recently, public interest in ESG is increasing, that is,interest in human rights, climate change, environmental❷ Eisai’s initiatives and its efforts directed toward the realization of hhceco
requires the establishment of a point of contact for
Akita: In the book, you state, “it is important to prevent
business partners. Eisai acted promptly. Outside
risks and also to respond promptly when things
partners and service providers are partners of Eisai.
happen.” I think the role of the consultation desk, which
From a broader supply chain perspective, complianceis the first touch point for promoting compliance, is very
must be ensured across all of Eisai’s activities. If theimportant. Can you give us your opinion about ourbusiness partner’s violation of compliance is left
consultation desk?
unsolved, it will bounce back directly to Eisai. On the
Nakajima: I think the consultation desk at Eisai is very
other hand, you don’t want Eisai to be able to exert
accessible. Ease of use and a sense of security areundue pressure on the business partner to reveal
important elements for the consultation desk. Our firm
information to which Eisai is not entitled. From bothalso provides the consultation desk for various
sides, I think a point of contact for our business partners
companies, and most of the people who use it areis needed. I feel that an external desk was set up at theworried that their personal information might beright time when you are aiming for “hhceco.”
revealed, or that they might be retaliated against. I
Akita: I would like to ask you about the ideal form of
explain that we report anonymously to the company.
compliance training at Eisai. In order to create an
The whistleblowers or informant may have thought
about it many times before deciding to make a report,
and they may have chosen the point of contact
carefully. In that respect, in addition to toll-free numbers
and emails, Eisai has prepared multiple channels suchas being able to submit emails via external providers,external law firms and specialists, and considers not
only anonymity but also ease of use.
Akita: In December 2021, we opened a consultation
desk for business partners on our corporate website.
What are your thoughts about such points of contact
for third parties?
Nakajima: The revised Whistleblower Protection Act

Foundation forSocial Value Creation

53

contributes to “People” and empowers “people to live
their lives to the fullest.” In an ecosystem, we aim tomeet healthcare needs in cooperation with various
external collaborators. In order to become an “hhceco”
company, we must be more aware of “society” thanever before, and I believe that we need to further
promote compliance in order to meet the diversifying
and complex expectations of our stakeholders.

Social Value Creation(Human Capital)

Akita: I have read your book, “All About Compliance”(Dai-ichi Hoki Co., Ltd.). In your book, you emphasizedthat “compliance” goes beyond “adherence to thelaw.” Could you explain why “compliance” goesbeyond "adherence to the law"?
Nakajima: This is a very important point. The jurist
Georg Jellinek stated that “law is an ethical minimum.”At the same time, “compliance should meet people’s
expectations.” So, it is on a higher level than the law.
Let us assume that a fire at a supermarket killed many
people. At the press conference, a question was posed,“Weren’t people killed because no sprinkler was
installed?”, and the management responded, “there isno obligation to install sprinklers under the Fire Service
Act, so we did not violate the law.” Don’t you feel there
is something wrong about this answer? Despite the fire
having killed people, management insisted that they
were obeying the law. I wondered if obeying the law
would constitute an apology, so I re-examined
compliance. “Comply” does not mean “observance oflaw and regulations” but “adjusting (to something).” With
Eisai, you are expected to have the sensibility toconsider what patients and people in general are
expecting, think for yourself, and adjust to it accordingly.
It is not a formal or “cold” thing like just observing therelevant laws and rules, but rather a recognition of theneed to consider “what others are expecting” and torespond to those expectations. I wrote in the book that,as such, compliance is a “warm” thing.
Akita: Our corporate concept is hhc, which is tocontribute to patients and their families. Going forward,
we aspire to transform into an “hhceco” company that

Social Value Creation(Access to Medicines) ompliance and observance of law■C❶ Important points for creating a corporate culture that emphasizes compliance
However, I would like to remind you that “whatAkita: The lessons from the international vitamin E
happened once can happen again” to keep you on yourcartel incident that occurred in 1999 have been learnt.
toes. In order to prevent this sort of thing fromWe have established a compliance promotion systemhappening again, it is important for all officers andand have endeavored to instill compliance awareness in
employees to work to keep a sense of urgency andeach employee. You have been advising us as aprevent similar cases from occurring. The word “ethicalmember of the Compliance Committee. What are yourfitness” appeared in a book “How Good People Make
thoughts on the efforts at Eisai?
Tough Choices--Resolving the Dilemmas of Ethical
Nakajima: It has now been more than 20 years since
Living” (Japanese translation published by Nikkei
the vitamin E cartel incident occurred, and as I see it,
Publishing) by the American corporate ethicist R.M.
Eisai continues to have a sense of eagerness and has
Kidder, which I translated. It refers to fitness in ethics.
been proactively promoting compliance. When I first
Initiatives such as compliance training sessions are likevisited Eisai as a member of the Complianceworkouts, and it is not enough to do them just once.
Committee, I was impressed that the training programs
The author states that ethical abilities can decline unlesswere extensive, and that everyone participating in theyou use them continuously, because it is a form ofprograms took them so seriously. Under the global
fitness. For a description of a healthy corporate body, I
compliance promoting system centered on thethink “ethical fitness” is a pretty good phrase. Eisai runs
Compliance Committee, systems in every region, suchits business with a sense of urgency and with a highas reporting desk and training programs, have beenlevel of compliance awareness. I hope that you will
established, and each employee is undertaking
continue to be vigilant going forward.
everyday business with an awareness of compliance.

Social Value Creation(R&D)

Shigeru Nakajima
Representative of Nakajima
Transactional Law Office
Registered lawyer since 1979.
Participated in the formulation of the
Keidanren’s “Charter of Corporate
Behavior” etc., and has served as
an outside corporate auditor atnumerous companies.
A member of Eisai Compliance
Committee since 2009.

of patients, patients’ families, and people living in thedaily living domain. I think that will lead to an
enhancement of the value of Eisai as a company.

Management Strategies

CCO Dialogue: Initiatives with compliance as the basisof management that supports hhceco

protection, and so on. Meeting those expectations is
the meaning of a company’s existence. Based on thehhc corporate concept, we will meet the expectations

A Message from the Chairperson of the Compliance Committee isk Management Promotion■R
Regarding risk management, Eisai defines risks as thethreat or probability that an action or event will adversely
affect the achievement of corporate and/ororganizational objectives. In order to avoid risks or keep
risks within acceptable levels, Eisai is carrying out
various initiatives, including the establishment,
development, and operation of internal control systems.
In accordance with the Companies Act, Eisai’s Board of
Directors formulated the Rules for Preparing Necessary
Systems for Ensuring the Appropriateness in the

Performance of Duties by Corporate Officers. These
rules stipulate that all corporate officers should identify
and evaluate the risks in their duties and establish,
develop, and operate internal control systems. Basedon the Eisai Network companies (ENW) Internal Control
Policy developed in response to the rules, we promotevarious initiatives, including establishment, development,
and operation of internal control systems throughout
ENW, and we are working to avoid risks or keep themwithin acceptable levels.

❶ Promoting the Risk Management System and Risk Response
The Risk Management Committee, chaired by thecommittee quickly detects similar potential risks in the
Corporate Officer in charge of internal control, centrallycompany and promptly responds to them through risk
manages important risks. Through continuous
avoidance and prevention activities.
monitoring of external corporate scandals, the●Eisai risk management structure<Board of Directors>• Establishment of rules for preparing necessary systems for ensuring the appropriateness in the performance of duties by corporate officers• Oversight of the establishment, maintenance, and operation of internal control by corporate officers
AdviseReportCorporate officer in charge of internal control
Risk Management Committee(Chair: Corporate officer in charge of internal control)

Corporate Compliance andRisk Management Department

Social Value Creation(Human Capital)• Centrally manage risk information• Proposals to and support for corporate officers

Secretariat(Provision of internal and external risk information)

Corporate officer

Corporate officer＊Control Self-Assessment

Corporate officer

Individual departments
and organizations

Establishment, maintenance,and operation of internal control

Department in charge of risk management
Person responsible for/person in chargeof promotion of CSA＊

Support for establishment,
maintenance, andoperation of internal
control (promotion of CSA)

management by developing an understanding of criticalrisks and follow-up on the status of risk responses bycorporate officers.

■ Internal Audit Activities Based on International Standards
evaluated from an independent standpoint, are reported
to the Board of Directors and to the Audit Committee.
To assure the quality of audits, the Corporate Internal
Audit Department undergoes assessment by an
external assessment committee composed of outside
experts in accordance with the standards of the Instituteof Internal Auditors (an international professional
association for internal auditors based in the U.S.).

For details of Risk Factors, please refer to pages 9-17 of the Notice of Convocation of the 110th Ordinary General Meeting of Shareholders

56

Eisai Value Creation Report 2022

Company Information

Internal audit is a voluntary audit that is different fromaudits by the audit committee and from accounting
audits. We have established the Corporate Internal
Audit Department under the Executive Officer in chargeof internal audit, and it conducts global internal audits incooperation with the internal audit departments in the
United States, Europe, China, Asia, and other regions.
The results of internal audits, assessed objectively and▶ https://www.eisai.com/ir/stock/meeting/pdf/einv110_all.pdf

55

Foundation forSocial Value Creation❷ Control Self-Assessment (CSA)
One of the tools used for risk management is CSA. In
CSA activity, department managers in ENW identify andevaluate risks every year, and then address these risks.
In addition, Eisai enhances the effectiveness of riskSocial Value Creation(Access to Medicines)

In the wake of the vitamin E cartel incident in the late 1990s, Eisai has taken aserious approach to compliance and risk management and has begun efforts toprevent compliance violations. As a proof of this, we have added “compliance(observance of legal and ethical standards)” to the corporate concept of hhc
and stipulated it in the Articles of Incorporation. But for many Eisai employees
today, the vitamin E cartel case may be a thing of a distant past, and the Articles
of Incorporation are far from their daily activities. Eisai’s challenge is to keep
employees remembering the importance of compliance and to maintain activities
Stuart Meiklejohn
to promote understanding of compliance, even when no issues have occurred.
Chairperson of the Compliance
Committee since 1999
Eisai established a compliance promotion system within a few years following
this case. An organization with thousands of employees around the world will
sometimes make mistakes (unforgivably, deliberate fraud too can happen). Eisai
is no exception. However, these incidents were relatively minor, and Eisai’s response was generally swift
and effective. Eisai has an unwavering spirit of compliance now. I can call it a passion for compliance. As to
how Eisai has achieved that, it all began with the true commitment of the top management. In addition,
great efforts were made to ensure that employees at all levels of the organization knew the rules and could
feel proud of their work. Sometimes it is said that business and compliance are considered different orincompatible, or that compliance is an obstacle. But in reality, it is the same. The business worth doing is
one that complies with all relevant laws, rules, policies, and procedures. There is always a legitimate way toreach objectives in business. Compliance is just a set of principles that help people find ways to reachobjectives. Eisai has established the Compliance Committee to support personnel who are in charge ofinternal compliance promotion. The committee’s meetings are attended by four outside lawyers withexpertise in each of the four regions where Eisai runs its business. In order to properly address compliance,
we must always be aware of, and respond to, global changes and challenges. We do our best to provide
guidance and perspectives on Eisai’s compliance efforts. Our role is to consult with personnel who are in
charge of compliance at Eisai. We also participate in training sessions for directors and officers, and makesure that the roles they play in order to promote compliance are well understood. If all Eisai employees
understand that compliance and business move in the same direction, then everything should work well.
Everything the company and its employees do should be directed toward the patients and customers. At
the same time, it must be done while complying with laws and rules, and persons involved must feel thatthey are doing the right thing. The Compliance Committee is honored to support and help Eisai’s efforts topromote compliance.

Risk Management and Internal Audit

Social Value Creation(R&D)

to society and would become a warm-hearted behavior.
And that behavior will be reflected in your life. Pursuing
hhceco and the happiness of patients and customers
could lead to gaining a sense of fulfillment from work,and to your own greater happiness. Since you spend asignificant part of your life at the company, it is best tocontribute to society through work and at the sametime make yourself happy.
Akita: Compliance could bring each person a sense of
self-fulfillment. I understand the importance of hhc andcompliance to be integrated. Thank you very much foryour time today.

Management Strategies

ecosystem in collaboration with external partners, I think
it is necessary to develop human resources who not
only contribute to Eisai, but also have a high awarenessof compliance, are trusted by partners, and cancontribute to society by building an ecosystem. I felt theneed to change the current content of compliancetraining that only teaches regulations and rules.
Nakajima: I hope that compliance trainings are
considered as a personal issue, not “what you receive
because it was instructed by the company.” I mentioned
earlier that compliance is more of a “warm” thing thansimply observance of formal rules. By being aware ofcompliance, perhaps a behavior could be more helpfulCFO/CIRO Message

At Eisai, we aim to maximize “long-term market
capitalization,” or “shareholder value,” not only byenhancing “financial capital” through the implementationof financial strategies, but also by increasing market
added value (MVA) through “non-financial capital” suchas “intellectual capital” and “human capital.”

Next, I would like to touch upon the direction of financial
and IR strategies. For more information on our financial
strategy, please see page 59-62.

Tatsuyuki Yasuno
Senior Vice President
Chief Financial Officer
Chief IR Officer

57

I believe that fiscal 2022 will be an exciting year for
Eisai. In order to maximize shareholder value, we will
steadily implement financial and IR strategies that wehave formulated, and we would like to ask for yourcontinued support from a medium- to long-term
perspective.

58

Eisai Value Creation Report 2022

Company Information

1. Direction of financial strategy
As mentioned, our financial strategy is centered around“medium- to long-term ROE management,” “sustainable
and stable shareholder returns,” and “value-created
investment criteria for growth,” which contribute toenhancement of shareholder value. However, if theaccelerated approval and following full approval oflecanemab, the expansion of Lenvima® indications, andthe commercialization of the subsequent pipeline are

2. Direction of IR strategy
IR is a communication activity through which acompany provides the capital market with corporate
information necessary for investment decisions in atimely, fair and continuous manner, and establishes aconstructive relationship between investors and thecompany. We understand that the goal of IR activity is
the formation of a fair value of our stocks as a result.
Eisai, as an innovation company originating in Japan,
is taking various initiatives to effectively realize social
good. We will accurately convey these various efforts,
the situation of the company, and its direction, toinstitutional and individual investors in Japan andoverseas from science, financial, non-financial, and ESG
perspectives. We also aim to listen carefully to investors’
opinions.

Foundation forSocial Value Creation

With the efforts to date, the company’s financial
soundness is in a solid state as of the end of fiscal
2021, and we are confident that we will be able toinvest in future growth strategies, particularly in ourorganic business, invest in business development byseizing growth opportunities, and provide sustainable
and stable shareholder returns, all based on a strong
balance sheet.
In addition, we recognize that an appropriate IR
strategy is important in maximizing “long-term market
capitalization” through “financial capital” and “nonfinancial capital.” We aim to maximize shareholder value
by further promoting appropriate disclosure throughadvancing IR activities and dialogue with shareholders,which could lead to the formation of appropriate stock
prices over the medium- to long-term. These strategies
remain unchanged.

achieved, the specific measures for the financial
strategy may change due to the rapid expansion of thebusiness.
In addition to making sufficient investments in the
launch of lecanemab and the expansion of indications
for Lenvima®, we will continue with research anddevelopment of next-generation Alzheimer's disease
treatments, farletuzumab ecteribululin (MORAb-202),
E7386, and other post-Lenvima pipelines, and we will
make solid investments in organic businesses, including
in China, India, and Africa. At the same time, it isessential to invest resources in People’s Business, todeploy hhceco by establishing Eisai Universal Platform(EUP). On the other hand, we are also considering how
to respond to deviations from the assumed scenario.

Social Value Creation(Human Capital)

In this rapidly changing global business environment, I
believe that the role of the CFO is to provide advice andsupport from the medium- to long-term management
perspective, so as to contribute to swift management
decisions. With my extensive business experience andknowledge, I will execute financial and IR activities
strategically as CFO/CIRO and will be deeply involved in
the planning and execution of each business to support
its growth. I intend to hold continuous dialogue anddiscussions on relevant topics with the corporate officer
in charge of each business, including measures forenvironmental changes, the strategies and issues ofeach business, and progress in relation to KPIs and theneed to review them, from the perspective of the CFO.

With regard to capital policy, which is the basis of our
financial strategy to strengthen financial capital, we have
and will continue to focus on “medium- to long-term
ROE management,” “sustainable and stableshareholder returns,” and “value-creating investment
criteria” as our core principles, which contribute toincreasing shareholder value while ensuring financial
soundness.

Social Value Creation(Access to Medicines)

My name is Tatsuyuki Yasuno, and I was appointed
CFO/CIRO on June 17, 2022.
Starting my career as a medical representative, I
have gained extensive business experience, including
corporate planning, European and U.S. business
operations, corporate strategy, and business alliances.
While inheriting the financial and IR strategies frommy predecessor, I would like to further evolve them withmy experiences and knowledge.

As an innovative company originating in Japan, we will maximize shareholder value based on “medium- to long-term
ROE management,” “sustainable and stable shareholder returns,” and “value-creating investment criteria for growth”

Social Value Creation(R&D)

Fulfilling my responsibilities as a CFO/CIRO with a wide
range of business experience and advanced knowledge

Management Strategies

Aiming at maximization of shareholder value byimplementing both investment in organic business growthand stable dividends based on a strong balance sheet

Financial Capital

Financial Strategy

5-year average ROE

Aiming to continuously maximize shareholder value based on “Medium- to Long-Term ROE Management,”“Sustainable and Stable Shareholder Returns,” and “Value-Creative Investment Criteria for Growth”
Eisai has set out a financial strategy map as its CFO policy to continuously maximize shareholder value. This strategy
consists of three key themes: “ROE management,” “Dividend policy,” and “Value-Creative Investment
Criteria (VCIC).”

Eisai has pursued an optimal capital structure while
maintaining financial integrity. Aiming to maintain a single
A level credit rating as a general rule, we have set the
KPIs of Net DER＊1 of -0.3 to 0.3, a ratio of equity
attributable to owners of the parent of 60% level
and Net Debt＊2/EBITDA＊3 of less than 3 years. By
undertaking business activities based on financial
discipline, we are steadily reducing interest-bearing(Billions of yen)
800

Investor relations

700
600

Financial strategies
ROE management

Optimal dividend policy
based on an optimal
capital structure
KPI＝8％ DOE model

Optimal capital structure

Cost of equity

Trade-off theory＊7
Credit rating: Single A level
Net DER: -0.3 to 0.3

Pecking order theory
Cost of equity: 8%
Equity spread

Reduction of costof equity throughIR activities

Value-Creative Investment
Criteria : VCIC•NPV & IRR•Risk-Adjusted Hurdle Rate (RAHR)PBR＝PER×ROE

628.1

57％

59％

678.1
64％

65％

（％）
80

748.8

70
60

60％

50

400

40

300

30

200

20

100

10

0

0

-100

-10

-200

-20

-300
-400

-0.27
End offiscal 2017-0.32
End offiscal 2018-0.29
End offiscal 2019

-0.27

-30

-0.32

End offiscal 2020

End offiscal 2021

-40

＊1 Net debt equity ratio (Net DER) = (Interest-bearing
debt (borrowings) - Cash and cash equivalents Time deposits exceeding three months - Investment
securities held by the parent company＊4) / Equity
attributable to owners of the parent＊2 Net interest-bearing debt = Interest-bearing debt
(borrowings) - Cash and cash equivalents - Timedeposits exceeding three months, etc. - Investment
securities held by the parent company＊4＊3 Earnings Before Interest, Taxes, Depreciation andAmortization＊4 Investment securities held by the parent company
except corporate venture capital (CVC) are included in
the formula.

Social Value Creation(Access to Medicines)•Margin: Partnerships/FAM＊4/
M&A/Tax policy•Turnover: CCC＊5/GCMS＊6•Financial leverage•Signaling effect＊2•Catering effect＊3•Balance sheet management

500

593.6

703.2

Social Value Creation(R&D)●Strong balance sheet —Dividend sustainability by maintaining optimal capital structure—●Financial strategy map for sustainable maximization of shareholder value＊1

Dividend policy

debt, and we secured a satisfactory net cash position
as of the end of fiscal 2021. Net DER was -0.32, theratio of equity attributable to owners of the parent was
60.4%, and Net Debt/EBITDA was -2.5 years. We havesecured not only sufficient financial integrity and liquidity
on hand to absorb the impact of COVID-19, etc., butalso sufficient achievement of KPIs in this period ofproactive investment.

Management Strategies

10% level

Using financial leverage

Ratio of equity attributable to owners of the parent ■Net debt equity ratio (Net DER)
■Equity attributable to owners of the parent ■Net interest-bearing debt■

Maximization of shareholder value

Increasing margins
Eisai has focused on expanding high-profit global brands discovered and developed in-house, such as Lenvima®,
Halaven®, and Dayvigo®. Eisai is aiming to improve its margin by effective operation through utilizing partnerships
and emphasizing careful selection of and concentration on priority projects.

Social Value Creation(Human Capital)＊1 Based on: Ikuo Nishikawa “Financial and Accounting Literacy to Enhance Corporate Value” (2016) Nikkei Publishing Inc.
＊2 Signaling effect: Potential impact on stock price by showing management’s belief in the achievement of the revenue forecast through dividend
policy＊3 Catering effect: Potential impact on stock price by meeting the expectation of shareholders’ preference for dividends＊4 FAM: Fixed Asset Monetization＊5 CCC: Cash Conversion Cycle＊6 G
 CMS: Global Cash Management System＊7 Trade-off theory: Idea to pursue optimal capital structure for debt finance and equity finance to use for balancing costs and benefits■ ROE Management —Targeting a positive equity spread over the medium- to long-term●Trends in ROE by fiscal year and medium- to long-term value creation(％)
20

Cost of equity (8%)

18.6

Historical 5-year average ROE(10.1％)

15

10

10.4

＊ Source: Ryohei Yanagi “CFO policy 2nd edition” (CHUOKEIZAI-SHA, 2021)

8.8
6.1

6.6

5

0

Eisai has effectively managed its cash conversion cycle(CCC) to control working capital, and has improved
asset efficiency through the sale of assets, including
investment securities. The Corporate Governance
Code, which was revised in June 2018, calls for thevalidation of benefits and risks of strategically held
shares. Before the revision of the Code, Eisai had soldstrategically held shares. In fiscal 2021, Eisai sold aportion of its strategically held shares in 1 listed stock
and all its shares of 2 unlisted stocks. In addition, Eisai
sold a portion of its deemed shareholding in 1 stock
and all of its deemed shareholding in another stock.
Aside from these, Eisai sold all of its shares held in 1
listed stock among its corporate venture capital (CVC)and other shareholdings.

●Trends in Number of Stocks (Listed) Held (Number of stocks)＊

30

32
25
20

20

16

15

10

0

fiscal2017

fiscal2018

fiscal2019

fiscal2020

fiscal2021＊N umber of stocks held includes deemed shareholdings, but excludes CVC andother such shares

Historical 5-year equity spread
Historical 5-year average ROE: 10.1% − CoE 8% = 2.1%
2017

2018

2019

2020

2021

(Fiscal year)■ROE (%)

59

60

Eisai Value Creation Report 2022

Company Information

Equity spread: ROE – Cost of equity (CoE)The key indicator of shareholder value creation
based on the residual income model ＊Eisai conservatively assumes cost of equity of 8%(risk-free rate of 2% + risk premium of 6%)

Improving turnover
Foundation forSocial Value Creation

Eisai has been working to improve its medium- to long-term ROE since the beginning of the 2000s. Eisai aims
to avoid short-termism and to achieve ROE above cost of equity over the medium- to long-term (e.g.,5-year average). In other words, Eisai aims to create a “positive equity spread (ROE – Cost of shareholders’equity).” Cost of shareholders’ equity is the return demanded by shareholders, and Eisai has conservatively assumed
a cost of shareholders’ equity of 8%. Eisai is generating a historical 5-year average ROE of 10.1% and a positive
equity spread of 2.1%.

■ Dividend Policy

Financial Strategy based on the ESG-Value Relevance Model＊1 “Net cash from operating activities”-“Capital expenditures (cash basis)”＊2 Dividends per share subject to approval of Board of Directors

the ② IIRC-PBR Model explains the relevance of six types ofcapital under the IIRC framework, by positioning Book Valueof Shareholders’ Equity (BV) as financial capital, and relating
MVA to “non-financial capital” consisting of “intellectual
capital,” “human capital,” “manufactured capital,” “social andrelationship capital” and “natural capital,” based on theassumption that shareholder value equals long-term total
market capitalization, and also equals BV plus MVA. In the ③
Residual Income Model (RIM), it is held that MVA converges
in the sum of present value of equity spread. Therefore, it canbe considered that future financial value creation based onequity spread over the long term does not conflict with
“non-financial capital” value such as ESG and MVA creationand is not mutually contradictory, and can be synchronizedas part of “stakeholder capitalism.”

In order to realize the value of ESG and non-financial
information, and link them to corporate value, it is necessary
to synchronize ESG and PBR. In light of medium- to longterm corporate value and sustainability (importance of
non-financial capital), Eisai has proposed a model (IIRC-PBR
Model) for the value relevance of “non-financial capital” basedon the corporate concept (hhc), since the International
Integrated Reporting Council (IIRC) framework was released,
and has promoted their synchronization. Technically,shareholders’ equity is the sum of the book value ofshareholders’ equity (BV) and market value added (MVA) thatexceeds BV. The portion that exceeds PBR of 1X is related to
ESG value, or “non-financial capital”. First, under the① Intrinsic Value Model, MVA was defined as “ESG/CSR
value (cost of capital reduction effects),” “customer value,”“human value,” and “organizational value.” In contrast to this,●IIRC-PBR model (Value relevance of the six types of capital that make up corporate value)—Net assets (book value on accounting basis) are related to financial capital and market value added (MVA) is related to non-financial capital—■ Value-Creative Investment Criteria (VCIC)

Non-financial capital including ESG＊1 increases long-term shareholder value
Added value creation by non-financial capital indicated by PBR＊2

Neurology

Trends in Eisai’s PBR (from the end of fiscal 2010 to end of fiscal 2021)

5

Oncology

Enhancement of non-financial capitalhhc ⇒ ESG ➡ SDGs＊3
Contribution to patients’ value
Contribution to employee value➡

Continuous increaseof shareholder value

Conversion to
future equity spread＊4Intellectual Capital

Potential Value

Non-financial capital(Times)
6

4

3

2

1

Market Value Added (MVA)(self-created goodwill)

Risk-adjusted hurdle rate = Risk free rate + β × Risk premium (+ liquidity premium)- Risk free rate: 10-year average yield of 10-year government bond- β: Defined by investment categories (risk profile)■ Funding Policy
As an efficient funding measure, Eisai has adopted a
Global Cash Management System (GCMS) for realizing
effective cash utilization among group companies.

Natural CapitalEnd of fiscal 2021

＊1 Environment, Social, and Governance＊2 Price Book-value Ratio＊3 Sustainable Development Goals＊4 ROE-Cost of Equity (CoE) (Eisai conservatively assumes cost of equity of 8%)
Source: Ryohei Yanagi “CFO policy 2nd edition” (CHUOKEIZAI-SHA, 2021), partially re-edited

Margin improvement

Non-Financial Capital

Reduction of
cost of equity

＊2

∑
（

61

62

）

Eisai Value Creation Report 2022

Company Information

In conjunction with the “Non-Financial Capital and equity
reduce R&D costs and personnel expenses in the short term
spread Value Relevance Model,” the Intrinsic Value Modeland buy back shares aggressively would undermine longwhich relates “non-financial capital” to MVA, the IIRC-PBR
term sustainability. For that reason, Eisai promotes sustainable
Model, and the Residual Income Model (RIM) which posits amanagement that aims to increase ROE in the long term, via
relationship between MVA and equity spread, are mutuallyinvestment in R&D, and in employees, with a long-term
complementary through the creation of MVA.
perspective.
In the Residual Income
Model, it is proven●Non-financial capital and equity spread value relevance model＊1
mathematically that the② IIRC-PBR Model① Intrinsic Value Modelpresent value of residual
Shareholder Value
income is a function ofIntellectual Capital
Sustainable Value(Value of ESG/CSR)
equity spread. This
Market Value Added (MVA)
Human Capitalsuggests that the portion
Manufactured Capital
Customer ValueBook Value of
Shareholders’ Equity (BV)
corresponding to PBRSocial and Relationship Capital
Human Value
above 1X is the ESG
Natural Capital
Organizational Value
value-added recognized by
Financial
Capital(IIRC framework)
investors, and that thisshould move into line with
③ Residual Income Model (RIM)
Sum of Present Value of Equity Spread (MVA)
Residual Income
the relative strength of ROE∞
Equity Spread × BV
Net income t − CoE × BV t-1
over the ultra-long term.
Shareholder Value = BV +
(
ROE
−
CoE
) × BV(Return on Equity attributable (Cost of Equity)(1+CoE)t
However, short-termism
t =1
to owners of the parent)
destroys this balance. For＊1 Ryohei Yanagi “CFO Policy 2nd edition” (CHUOKEIZAI-SHA, 2021), partially edited
example, an attempt to＊2 Ryohei Yanagi “Financial Strategies for Maximizing Corporate Value” (Doyukan, 2009)

Foundation forSocial Value Creation

Eisai’s funding policy is based on the pecking ordertheory. Eisai prioritizes cash on hand over debt, andequity financing is the last option.

Social and
Relationship Capital

Financial Capital0

End of fiscal 2010

Manufactured CapitalSocial Value Creation(Human Capital)

Net assets (book value on accounting basis)

Risk-adjusted hurdle rate formula

Human CapitalSocial Value Creation(Access to Medicines)

risk elements, such as the particular investment project,
the investee country, and liquidity. We haveapproximately 200 types of hurdle rates, and we apply
the risk-adjusted hurdle rate appropriate for each
respective investment project.
The Corporate Governance Code, which was revisedin June 2018, calls for the allocation of management
resources in a manner that takes into account the costof shareholders’ equity. Eisai introduced VCIC in 2013
to ensure corporate value creation.

Prioritization and selection of investments are becoming
even more important for companies to achieve growth.
Therefore, Eisai has set Value-Creative Investment
Criteria (VCIC) for its strategic investments to ensure
value creation. When making investments, we use Net
Present Value (NPV) and the Internal Rate of Return(IRR) spread using a risk-adjusted hurdle rate as KPIs.
In principle, we select only those investments with apositive NPV, and set a certain spread for IRR to assure
value creation. In setting hurdle rates, we factor in all

Social Value Creation(R&D)

principle, Eisai strives to maintain dividends within therange of free cash flow over multiple years. Eisai has
maintained a healthy balance sheet under present
conditions. Therefore, we intend to maintain adividend of 160 yen per share in fiscal 2022＊2 withan intention to balance stable dividend payment andinvestment for corporate growth. Acquisition of treasury
stock will be carried out appropriately after factors suchas the market environment, theoretical share price, andcapital efficiency (ROE) are taken into account.

Management Strategies

Eisai returns profits to all shareholders in a stable
and sustainable manner, comprehensively taking into
account consolidated financial results, dividend on
equity (DOE, the ratio of equity attributable to owners of
the parent company), free cash flow＊1, signal effects,
and other factors. We strive for an “optimal dividend
policy based on an optimal capital structure” that
depends on long-term balance sheet management,
rather than a dividend payout ratio based on short-term
performance. As a main KPI for dividends, from theperspective of balance sheet management, Eisai has
adopted DOE, which indicates the ratio of dividends toconsolidated net assets.
While the payout ratio is currently increasing, in1980s —Establishment of Eisai

Our founder, Toyoji Naito, established Eisai andfocused on medicine creation activities,
because he was dissatisfied with how Japan’s
drug industry at the time remained overly
reliant on imports.

Founder: Toyoji Naito

Commenced full-fledged overseas expansion

Eisai Research Institute of
Boston, Inc.

Late 1960s to early 1970s
Local subsidiaries established in Southeast Asia

Launched in-house-developed new products
2012: Launched antiepileptic agent Fycompa®
2015: Launched anticancer agent Lenvima®

2015

Lenvima®

Fiscal 2016 and after

Launched proton-pumpinhibitor Pariet®

1997 in the U.S.
and Europe (U.K.)
1999 in Japan

1997 in Japan
1998 in Europe (U.K.)
1999 in the U.S.
(brand name: AcipHex®)

Fiscal 2016 to Fiscal 2020

Major in-house products
2020

1997

Launched Alzheimer’s
disease (AD) treatment Aricept®

Aricept®

Launched in-house-developed new products
2020: Launched anti-insomnia drug Dayvigo ®

1997

Fiscal 2021 and after・Change our viewpoint from

■Issues
Dispersion of R&D resources
Unable to launch in-house-developed
new productsTrends in Sales Revenue and Operating Profit＊1

021
ca
for l 2 0 2
ec 2
as
t
fis

l2

02

ca
fis

l2
ca

ca
fis

0

01
9

0
fis

ca
fis

l2

01
8

ca
fis

l2

ca
fis

l2

01
7

01
6

ca
fis

l2

01
5

ca
fis

l2

01
4

ca
fis

l2

01
3

ca
fis

l2

ca
fis

l2

ca

l2

01
1

01
0

Plan Hayabusa

l2

40

EWAY
Future & Beyond

EWAY
Current

fis

ca
fis

l2

00

00

8

7 ＊2

l2
ca

00

00

l2

ca
fis

fis

6

5
ca

fis

l2

ca
fis

l2

ca
fis

l2

00

00

00

3

4

Millennium Plan

0

9

Dramatic
Leap Plan

01
2

200

l2

Dispersion of R&D resources(eribulin mesylate) Injection

2■Issues
Under-achievement of performance targets（Revenue ¥1 trillion, Operating profit ¥200 billion）

53.7 55.0

l2

Halaven

120
80

400
®

ca

・Achievement of record revenue (fiscal 2009）

2010

fis

¥322.8 billion (fiscal 2009)¥175.9 billion (fiscal 2007)¥470.8 billion (fiscal 2009)

700.0

600

160

＊1 Results up to fiscal 2013 were calculated pursuant to J-GAAP, while results for fiscal 2014 and beyond were calculated pursuant to IFRS.
＊2 The reduction in operating profit in fiscal 2007 reflected the acquisition of MGI Pharma, Inc.

63

64

Eisai Value Creation Report 2022

Company Information

Aricept
Pariet®
Total

756.2

00

Vizag Plant (India)

Operating profit(Billions of yen)

Operating profit

800

・Establishment of product supply system
based on affordable pricing
・Completion of Vizag
Plant in India

Reached peak sales of 2 major brands®

Revenue

Revenue (Billions of yen)Foundation forSocial Value Creation2007 : Acquired Morphotek, Inc. in the U.S.
2008 : Acquired MGI Pharma, Inc. in the U.S.
2010 : Established H3 Biomedicine Inc.
in the U.S.
Launched anticancer agent Halaven®

Partnership agreement in oncology area
2021: Entered into an exclusive global strategic
collaboration agreement with Bristol-Myers Squibb
for the co-development and co-commercialization of
MORAb-202, an antibody drug conjugate (ADC).

“Patients” to “people in the dailyliving domain”
・Realization of hhc ecosystem (hhceco)
・Empowering people to live their lives
to the fullest

Dramatic Leap Plan

■Outcomes

EWAY Future & Beyond

Social Value Creation(Human Capital)

Pariet®

・Achievement of major KPIs a year ahead of schedule (Revenue ¥600 billion, Operating profit ¥100 billion)
・Enhancement of corporate governance・Strengthened foundations in oncology area

・Accelerated the development of Alzheimer’s disease
treatments through a co-development and co-promotion
agreement for Alzheimer’s disease treatments with
Biogen Inc. (2014)
・Dramatic growth of anti-cancer agent Lenvima®
triggered by strategic alliance agreement withMerck & Co., Inc., Rahway, NJ, USA (2018)

・Achieved operating profit target for fiscal 2020
and ROE target for fiscal 2025 ahead of schedule(fiscal 2019)

Millennium Plan

2004 Transitioned to become a company with a nomination committee, etc.
2005 Incorporated the corporate concept into the Company’s
Articles of Incorporation

EWAY Current■Outcomes

Dayvigo®

■Outcomes

1941年
Fiscal2006 to Fiscal 2010

Plan EWAY

Social Value Creation(Access to Medicines)

1941年
Late
1990s — Growth of two major brands accelerated global business expansion■Issues
Under achievement of performance targets (Revenue over ¥800 billion,
Operating profit over ¥200 billion)
Lack of capability to
Loss of exclusivity (LOE)
respond to changes in thein 2 major brands
business environment
Pariet ®
Aricept ®
due to LOE in 2 major brands
2010 in the U.S. 2010 in Japan
2011 in Japan 2012 in Europe
2012 in Europe 2013 in the U.S.

・Strengthened efforts to improve access to
medicines

1988 Appointment of Haruo Naito, the present CEO
1992 Adopted the corporate concept of“human health care (hhc)”

Yuji Naito

Plan Hayabusa■Outcomes
・Enhancement of business in China and Asia®

Entry into dementia and oncology areas
1983 Commenced drug discovery research on dementia
at Tsukuba Research Laboratories
1987 Launched R&D group to develop anticancer agentsat Tsukuba Research Laboratories

Yuji Naito was appointed as the second Presidentof Eisai in 1966, and proactively promoted
overseas expansion.

1941年
Fiscal2002 to Fiscal 2005

Fycompa®

Eisai London ResearchLaboratories, Ltd.

ca

Late 1960s

1941年
Fiscal2011 to Fiscal 2015

2012

・Oncology area
Merck & Co., Inc.,
Rahway, NJ, USA・Neurology area
Biogen Inc.

Formulated partnerships in the neurology and oncology areas
2014: Entered into a collaboration agreement with Biogen Inc. forthe development and commercialization of AD treatments
2018: Entered into global strategic oncology collaboration for Lenvima®
with Merck & Co., Inc., Rahway, NJ, USA

Three-hub R&D network established1982 Tsukuba Research Laboratories (Japan)
1989 Eisai Research Institute of Boston, Inc. (U.S.)
1992 Eisai London Research Laboratories, Ltd. (U.K.)

Tsukuba Research Laboratories

Value creation through in-house-developed new products and the partnership modelSocial Value Creation(R&D)

1941 Established Nihon Eisai Co., Ltd.
1955 Changed corporate namefrom Nihon Eisai Co., Ltd. to Eisai Co., Ltd.

2010s —

Established a foundation for global business expansion

fis

1941

Concentration of resources in the neurology and oncology areas

Management Strategies

History of Eisai

Remitoro® (generic name: denileukin diftitox [genetical recombination]) In-house

In-house

Anticancer agent/microtubule dynamics inhibitor

Neurology Area Revenue in fiscal 2021: ¥135.6 billion (accounting for 17.9% of consolidated revenue, and 84.0% of fiscal 2020)
Fycompa® (generic name: perampanel)

In-house

Antiepileptic agent
Revenue in fiscal 2021: ¥31.9 billion (119.2% of fiscal 2020)

In-house

New Product (launched in May 2021)

An anticancer agent developed inhouse. A synthetic analog of halichondrin
B derived from the marine sponge
Halichondria okadai. Shows an antitumor
effect by arresting the cell cycle throughinhibition of the growth of microtubules.
Approved for the treatment of breast
cancer and liposarcoma (soft tissue
sarcoma in Japan) in over 80 countries.

An anticancer agent developed inhouse. The agent is a fusion protein
consisting of interleukin-2 (IL-2) andpartial sequence of diphtheria toxin, andspecifically binds to the IL-2 receptor on
the surface of tumoral lymphocytes. The
antitumor efficacy of denileukin diftitox
is believed to depend on the intracellular delivery of diphtheria
toxin fragment which inhibits protein synthesis and induces cell
death. It is marketed for the treatment of relapsed or refractory
Peripheral T-Cell Lymphoma (PTCL) or Cutaneous T-Cell
Lymphoma (CTCL) in Japan.

Tazverik® (generic name: tazemetostat)

Others Revenue in fiscal 2021: ¥228.3 billion (accounting for

In-licensed

30.2% of consolidated revenue, and 105.6% of fiscal 2020)

Anti-insomnia drug

Anticancer agent/EZH2 inhibitor

Revenue in fiscal 2021: ¥16.4 billion (525.2% of fiscal 2020)

New Product (launched in August 2021)

Jyseleca® (generic name: filgotinib)

Dayvigo® is an orexin receptor antagonist that inhibits orexin neurotransmission regulating sleepwake rhythm by binding competitively to the two subtypes of orexin receptors (OX1R and OX2R).
Dayvigo® acts on the orexin neurotransmitter system and is believed to facilitate sleep onset,
sleep maintenance, and waking by regulating the sleep-wake rhythm. It has been approved forthe treatment of insomnia in over 10 countries including Japan, the U.S., and countries in Asia.
Revenue is steadily increasing, mainly in Japan.

Developed by utilizing the
proprietary product platformof Epizyme, Inc. (in the U.S.),
Tazverik is a first-in-class, oral
EZH2 inhibitor. It is one of thehistone methyltransferases in theepigenetics-related protein group,
which is thought to regulate theexpression of cancer-related
genes and suppress the growth of cancer cells by specificallytargeting EZH2. It may also contribute toward controlling thecancer growth process. In Japan, where Eisai is responsible forthe development and commercialization, it has been launched
for the treatment of relapsed or refractory EZH2 gene mutationpositive follicular lymphoma in August 2021.

Janus kinase (JAK) inhibitor

Methycobal® (generic name: mecobalamin)

In-house

In-house

Peripheral neuropathy treatment

Revenue in fiscal 2021: ¥24.4 billion (92.8% of fiscal 2020)

Revenue in fiscal 2021: ¥28.1 billion (82.3% of fiscal 2020)

A dementia treatment developed
in-house that is believed toslow the overall progressionof symptoms associated with
Alzheimer’s disease by inhibiting
the acetylcholinesterase
enzyme, which breaks down theneurotransmitter acetylcholine. Currently approved in over 100
countries worldwide. The agent was approved in Japan, thePhilippines, and Thailand for the additional indication for thetreatment of Lewy body dementia.

A mecobalamin (Vitamin B12coenzyme) product developed
in-house. Restores damaged
peripheral nerves and is
widely used for the treatmentof peripheral neuropathy inJapan and countries in Asia.

Goofice® (generic name: elobixibat)

＊A
 n Alzheimer’s disease treatment, ADUHELM®, was deleted from the list due to the amendment of a collaboration agreement with Biogen Inc. (the U.S.) in March 2022. Under the amended agreement,
Biogen Inc. has sole decision making and commercialization rights worldwide.

A novel once-daily oral
preferential JAK-1 inhibitor.
Gilead Sciences K.K. received
approval for the treatment ofrheumatoid arthritis in Japan inNovember 2020 and ismarketed by Eisai. In March
2022, Jyseleca was also approved for the treatment of patientswith moderately to severely active ulcerative colitis. Gilead
Sciences K.K. has been co-promoting Jyseleca with Eisai’s
subsidiary, EA Pharma.

Carogra® (generic name: carotegrast methyl)

In-licensed

Treatment of Ulcerative Colitis/α4 integrin antagonist

Revenue in fiscal 2021: ¥6.1 billion (123.0% of fiscal 2020)

New Product (launched in May 2022)

Goofice® is a once daily, oral
constipation treatment witha novel action mechanism
in-licensed by EA Pharma
from Albireo AB (Sweden).
Goofice is believed to stimulate
defecation by increasing the flow of bile acids to the large
intestine, softening the stool, and activating bowel movement.
EA Pharma and Mochida Pharmaceutical Co., Ltd. market the
product respectively, and Eisai co-promotes the product withEA Pharma.

Carogra, a small molecule compound
discovered by EA Pharma, is theworld's first α4 integrin antagonist to
be launched in oral form. It is thought todemonstrate anti-inflammatory effect bysuppressing excessive accumulation/
infiltration of inflammatory cells, which
are found in the lesion area of colorectal mucosa, throughinhibition of cell adhesion reactions, associated with bindingof adhesion molecules that are overexpressed on vascularendothelial cells in the colon mucosa. Carogra® is distributed
by Kissei Pharmaceutical Industries, Ltd. and co-promoted by
EA Pharma.

In-house

Consumer Healthcare Business
Revenue in fiscal 2021: ¥23.8 billion(accounting for 3.2% of consolidated revenue, and 94.7% of fiscal 2020)

Anticancer agent/molecular targeted medicine
Revenue in fiscal 2021: ¥192.3 billion (143.6% of fiscal 2020)

This includes our signature
product, Chocola BB® Plus, avitamin B2 preparation for roughskin and stomatitis, as well as
a variety of other products,
including Class 3 OTC drugs,
designated quasi-drugs, andnutritionally functional foods.

(17.2%)

Consumerhealthcare
business¥23.8 billion(3.2%)
Other¥228.3 billion(30.2%)®

Chocola BB Plus:Class 3 OTC drug

Prescription
drug business¥129.9 billion

Revenue in fiscal 2021: ¥14.3 billion (106.4% of fiscal 2020)

Chocola.com▶ https://www.chocola.com/index.html(Only in Japanese)65

Other business＊

Chocola BB® Products®

Chocola BB Royal 2:
Designated quasi-drug

66¥602.5 billion
Consolidated
revenue infiscal 2021

¥756.2billion(79.7%)

Neurology area

¥135.6 billion(17.9%)

Oncology area

¥238.5 billion(31.5%)＊ Other business includes an upfront payment of ¥69.2 billion from Merck &Co., Inc., Rahway, NJ, USA for achieving sales milestones for Lenvima® andan upfront payment of ¥49.6 billion for the collaboration with Bristol Myers
Squibb regarding MORAb-202.

Eisai Value Creation Report 2022

Company Information

A selective tyrosine kinase inhibitor (TKI) with a novel binding mode developed in-house. Indications
for treatments of refractory thyroid cancer and unresectable hepatocellular carcinoma areapproved in over 80 countries. Also, approved as treatment renal cell carcinoma (second-line) in
combination with everolimus in over 65 countries and for treatment of renal cell carcinoma (firstline) in combination with pembrolizumab in over 40 countries (product name for treatment of renal
cell carcinoma in Europe: Kisplyx®). Approved for combination therapy with pembrolizumab foradvanced endometrial carcinoma (following prior systemic therapy) in over 45 countries. In Japan,
approved for thymic cancer as monotherapy. Revenue is steadily increasing worldwide. Joint
development and commercialization with Merck & Co., Inc., Rahway, NJ, USA (known as MSD
outside the U.S. and Canada) is ongoing globally.

●Revenue of prescription drug business, consumer healthcare businessand others

Foundation forSocial Value Creation

Bile acid transporter inhibitor

Oncology Area Revenue in fiscal 2021: ¥238.5 billion (accounting for 31.5% of consolidated revenue, and 130.1% of fiscal 2020)
Lenvima® (generic name: lenvatinib)

In-house

Social Value Creation(Human Capital)

Treatment for Alzheimer’s disease/dementia with Lewy bodies

Revenue in fiscal 2021: ¥1.5 billion

Social Value Creation(Access to Medicines)

Aricept® (generic name: donepezil)

In-licensed

Social Value Creation(R&D)

An AMPA receptor antagonist developed in-house. Fycompa® has been approved in over 70
countries including Japan, the U.S., and countries in Europe and Asia for monotherapy andadjunctive use in the treatment of partial onset seizures and for adjunctive use in the treatmentof primary generalized tonic-clonic seizures. The oral suspension formulation was approved in
the U.S. and Europe, and the fine granule was approved in Japan. Revenue is steadily increasing
worldwide.

Dayvigo® (generic name: lemborexant)

Anticancer agent/a fusion protein consisting of IL-2 and partial
sequence of diphtheria toxin

Revenue in fiscal 2021: ¥39.4 billion (104.8% of fiscal 2020)

Management Strategies

Halaven® (generic name: eribulin)

Major Products

Management Strategies

Global Business Outlook

Eisai is strengthening its strong business foundation globally by leveraging marketing activities and partnerships thatare tailored not only to its own business base, but also to the specific characteristics of each region, including Japan,
the Americas, China, EMEA, Asia, and Latin America.

Fiscal 2021 Results

Trends in Revenue by Region＊1

Segment Revenue
Asia andLatin America¥50.6 billion

Segment Profit

Japan

Americas(Billions of yen)(Billions of yen)

172.0

272.0

257.0

(32%)

(31%)

EMEA
¥59.3 billion

300

(17%)

Other business¥121.6 billion

Japan＊¥237.9 billion

301.1

Consolidated Revenue

Segment Profit Total¥756.2 billion¥384.0 billion

Americas¥79.2 billion

237.9

Social Value Creation
(R&D)

(17%)

198.5

200

Japan＊¥65.9 billion

Other business¥129.9 billion

(7%)

142.8

225.5

127.9

200
97.9

100

(21%)

(8%)

China
¥106.4 billion

Americas¥172.0 billion(14%)

Asia andLatin America¥20.8 billion

(23%)

100

China
¥55.4 billion

EMEA¥40.9 billion

(14%)

(11%)

0

(5%)

＊ Includes profit of consumer healthcare businessfiscal2012

fiscal2013

fiscal2014

fiscal2015

fiscal2016

Number of Employees (As of the End of Fiscal 2021)

®

China
Approx. 20

106.4

100

11,322

China
2,044

Number of Employees
in the R&D Division(41%)

Americas
Approx. 720

Approx. 2,000

fiscal2014

fiscal2015

fiscal2016

Japan
Approx. 1,120(Approx. 56%)

fiscal2017

fiscal
2018

97.5

85.1

Japan
4,591

fiscal2013

fiscal2019

fiscal2020

fiscal forecast for fiscal
2021
2022

66.3

77.0

fiscal2018

fiscal
2019

49.8

50

53.7

55.2

59.3

59.5

50

(Approx. 36%)

(18%)

Americas
1,982

0

(18%)

fiscal2012

fiscal2013

fiscal2014

fiscal2015

fiscal2016

fiscal2017

fiscal2020

0fiscal forecast for fiscal
2022
2021

Production Division

Number of Medical Representatives (MRs)

®

®

®

®

(Approx. 20%)

Japan
Approx. 570

EMEA
Approx. 170(Approx. 9%)

EMEA
360

(Approx. 32%)

(Approx. 26%)

46.6

fiscal2020

fiscal forecast for fiscal
2022
2021

■Others

129.9

50.6
45.9

118.4

45.5

100

(Approx. 28%)

79.1

73.5
59.9

50

Americas
Approx. 700(Approx. 18%)0fiscal2012

fiscal2013

fiscal2014

fiscal2015

fiscal2016■Aricept ■Pariet ■Methycobal■Lenvima® ■Humira® ■Others®

(Approx. 7%)

fiscal2019

fiscal2018®

®

fiscal2017

fiscal2018■Halaven®

fiscal2019■Fycompa

fiscal2020

0fiscal forecast for fiscal
2022
2021

fiscal2012

fiscal2013

fiscal2014

fiscal2015

fiscal2016

fiscal2017

fiscal2018

fiscal2019

fiscal2020■Others ■Recognition of payments associated with Lenvima®

®

fiscal forecast for fiscal
2022
2021

＊1 From April 1, 2022, Hong Kong was changed from Asia and Latin America pharmaceutical business to China pharmaceutical business. This change
has been reflected in the segment information for fiscal 2022 forecast. Each product’s revenue not disclosed in fiscal 2022 forecasts and recognition of
payments associated with Lenvima® expected in fiscal 2022 are included in forecasts for “Others.”
 eneric business was fully transferred to Nichi-Iko Pharmaceutical Co., Ltd. in April 2019.
＊2 G urope, Middle East, Africa, Russia and Oceania＊3 E outh Korea, Taiwan, Hong Kong, India, ASEAN, Central and South America (until fiscal 2021) South Korea, Taiwan, India, ASEAN, Central and South＊4 S
America (fiscal 2022 onwards)

67

68

Eisai Value Creation Report 2022

Company Information

Americas
Approx. 120

fiscal
2017

MRs

China
1,050

China
Approx. 590

48.7

Approx. 4,000(Approx. 9%)

Approx. 1,820

fiscal2016

Other businessJapan
Approx. 1,110(Approx. 31%)

Number of Employees
in the Production Division

fiscal2015(Billions of yen)

50

(Approx. 20%)

fiscal2014

Foundation forSocial Value Creation

Asia andLatin America
Approx. 370

fiscal2013

Asia and Latin America＊4(Billions of yen)

Asia andLatin America
Approx. 780

fiscal2012■Aricept® ■Pariet® ■Halaven® ■Fycompa®
■Lenvima® ■3 antiepileptic agents total (Inovelon®, Zonegran®, Zebinix®)■Aricept ■Pariet ■Methycobal ■Halaven ■Fycompa■Lenvima® ■Stronger Neo-Minophagen C® and Glycyron Tablets® ■Others®

Social Value Creation(Human Capital)

Consolidated
Number of Employees

fiscal2012■Aricept® ■AcipHex® ■Aloxi® ■Halaven®
■Fycompa® ■Lenvima® ■Dayvigo® ■Others®

(Billions of yen)(Billions of yen)

EMEA
1,200
(11%)

0

fiscal forecast for fiscal
2022
2021

EMEA＊3(Approx. 1%)(13%)

fiscal2020®

(Approx. 3%)(Approx. 4%)

Asia andLatin America
1,505

fiscal
2019

®

China

Asia and Latin America
Approx. 50

EMEA
Approx. 80

fiscal2018®

R&D Division

Employees by Region

fiscal2017■Aricept ■Pariet ■Halaven ■Fycompa ■Lenvima ■Dayvigo■Humira® ■Lyrica® ■Others ■OTC and others ■Generics＊2®

Social Value Creation(Access to Medicines)＊ Includes revenue of consumer healthcare businessIndependent Assurance ReportManagement Strategies

ESG Indices
Scope of data: ■ Eisai Group (Eisai Co., Ltd. and Group companies in and outside Japan) ■Eisai Co., Ltd. ■Eisai Group in Japan (Eisai Co., Ltd. and Group companies in Japan)＊ Data for subsidiaries and transferred businesses are included until the date of the event.
PeriodAt fiscal year end
At fiscal year end
At fiscal year end
At fiscal year end
At fiscal year end

Annually
At fiscal year end
Annually
PeriodAt fiscal year end

At fiscal year end

Number of hired new graduates

1,022

1,046

1,113

☑1,166☑1,200

1,906
1,374
－
－
3,436
2,708
728
21.2%
1,228
86
7.0%
21.3%
13/61
45.3
20.8
21.9
16.9
2.5%
－
3.4%
－
－
97
5
92
－
75

2,069
1,419
－
－
3,411
2,679
732
21.5%
1,250
100
8.0%
23.9%
17/71
45.3
21.2
22.3
17.3
2.2%
－
11.4%
－
－
105
6
99
58
90

2,087
1,523
－
－
3,212
2,479
733
22.8%
1,203
116
9.6%
23.1%
15/65
45.0
19.9
21.3
15.4
2.1%
－
7.5%
－
－
91
8
83
78
69

☑2,060☑1,578
☑40%
☑28%
3,212
☑2,435
☑777
24.2%
1,198
125
10.4%
18.3%
11/60
44.4
18.9
20.4
14.3
2.0%
－
7.6%
－
－
110
20
90
49
61

☑2,044☑1,505☑41%☑33%
3,200 ＊1
☑2,367 ＊1
☑833
＊1
26.0%
1,187 ＊2
137 ＊2
11.5% ＊2
28.1%
＊2
18/64
43.4 ＊1
17.8 ＊1
19.6 ＊1
12.6 ＊1
3.1% ＊1,3
11% ＊3
4.0% ＊1,4
15% ＊485%
133 ＊1,540 ＊1,593 ＊1,559 ＊1,650 ＊1

11,063

10,401

10,403

10,93910,38910,446

10,992

10,37010,424

259

213

9,202
188 ＊1,7

176

198

210

214

221

2.56%
14.3%
2/14
3
2
1

2.53%
33.3%
35/105
100
66
34

2.65%
38.2%
21/55
39
20
19

2.84%
44.3%
31/70
43
23
20

2.88%
36.3％
33/91
57
32
25

2.62% ☑2.63% ☑2.33%
39.8％
39.7%
45.1%
＊1
74/186 100/252 116/257
97
130
197 ＊1,8
50
67
93 ＊1,847
63
104 ＊1,8

Annually

10h27m10h46m12h11m

9h11m

8h34m

9h44m

10h28m11h10m12h32mAnnually
Annually

42
－
0.19
0

16
－
0.10
0

9
－
0
0

16
－
0
0

23
－
0.10
0

19
－
0.10
0

17
－
0.20
0

11
－
0
0

21
－
0
0

21 ＊9
☑66 ＊90.31 ＊9
0

－

－

－

－

－

－

－

－

－

☑0.52 ＊9,10

Annually

0
0
－

0
0
－

0
0
－

0
0
－

1
0
－

0
0
－

0
0
－

0
0
－

0
0
－

0 ＊9
0
0 ＊9

Annually

12.7

12.3

12.1

12.1

12.4

12.9

13.5

12.5

11.5

Annually

Employee
Contractor

Annually

Frequency of work-related injuries that resulted in morethan 1 day of work lost (per million hours of actual work)

Employee

Annually

Number of work-related fatalities

Employee
Contractor
Employee

Annually

13h59m11.2＊1 Based on the number of fulltime Eisai Co., Ltd. employees, including employees dispatched to Eisai Network Companies (ENW) ＊2 Based on the number of employees disclosed in the
Annual Securities Report (Eisai Co., Ltd. employees include those dispatched from ENW and exclude those dispatched to ENW) ＊3 Voluntary termination only, not including mandatory
retirement due to age, voluntary retirement, etc. ＊4 Covering all forms of leaving the Company, such as voluntary termination, mandatory retirement due to age, voluntary retirement, etc.
＊5 Childcare leave program: Entitlement: Workers who have served the company for 1 year or more and requested childcare leave for child/children under the age of 3; Period: Until the
day specified by the employee, provided that this is before the child’s 3rd birthday ＊6 Spousal maternity leave program (Launched in April 2018): Entitlement: Workers whose partner has
given birth; Period: Up to 5 days of special paid holiday ＊7 Personal development expenses include training, studying abroad, and participation in academic conferences ＊8 Not including
employees who joined the company midway through the year ＊9 These figures cover employees, part-time workers, and temporary workers.
＊10 In order to promote the prevention of global occupational accidents and injuries, a new standard for calculating the frequency rate was established in fiscal 2021.
Eisai Group lost-time injury frequency rate (per million hours worked) = Number of casualties resulting from occupational and traffic accidents (absence of 1 day or more) ÷ Total working
hours × 1,000,000
According to the 2021 Survey of Occupational Accident Trends conducted by the Ministry of Health, Labour and Welfare, the lost-time injury frequency rate for the manufacturing industry
was 1.31. The number of occupational illnesses was also counted in the number of occupational and traffic accidents, so it was removed from the table in fiscal 2022.
☑ This information is guaranteed by SGS Japan K.K. Years for which no data were obtained are indicated by “-”.

For further details of the independent assurance report,
please refer to Eisai’s Corporate Website.
▶ https://www.eisai.com/sustainability/management/pdf/eesg_index.pdf

For further details of ESG indices, please refer to Eisai’s Corporate Website. ▶ https://www.eisai.com/sustainability/management/pdf/esg_index.pdf

69

70

Eisai Value Creation Report 2022

Company Information

177
2.39%
36.9%
31/84
76
46
30

Frequency of work-related injuries that resulted in morethan 4 days of work lost (per million hours of actual work)

Average days of paid holidays taken(per non-management employee)

983
1,909
1,255
－
－
3,508
2,775
733
20.9%
1,206
72
6.0%
17.6%
9/51
44.8
20.4
21.4
16.9
3.1%
－
3.8%
－
－
89
0
89
－
80

162

Annually

Average monthly overtime hours(per non-management employee)
Number of work-related accidents(lost time injuries, traffic accidents)

913
1,875
1,276
－
－
3,577
2,838
739
20.7%
1,292
65
5.0%
11.6%
5/43
44.1
19.9
20.8
16.2
2.6%
－
3.0%
－
－
95
2
93
－
93

2.37%
50.0%
14/28
21
12
9

Annually

Total
Male
Female

893
1,607
1,252
－
－
3,583
2,845
738
20.6%
1,282
61
4.8%
15.4%
6/39
43.7
19.4
20.3
15.9
1.4%
－
1.9%
－
－
90
1
89
－
73

Foundation forSocial Value Creation

Percentage of handicapped employees
Share of annual female hires(Female/Total)

811
1,559
1,086
－
－
4,130
3,202
928
22.5%
1,370
59
4.3%
17.4%
8/46
42.5
20
20.7
17.8
1.8%
－
14.2%
－
－
78
1
77
－
86

Social Value Creation(Human Capital)

Total
At fiscal year end
FemaleTotal
Ratio of women in management
Newly appointed At fiscal year end
managers
Average age
At fiscal year end
Total
Average years of employment
Male
At fiscal year end
FemaleAnnually
Turnover rate (resignation)
Annually
Annually
Total turnover rate
Annually
Employee engagement/satisfaction
Annually
Total
Number of users of childcare leave
Male
Annually
program
FemaleNumber of users of spousal maternity leave program
Annually
Number of users of short working hours program for childcare
Annually
Average annual salary
Annually(Thousands of yen) (according to the annual securities report)
Personal development expenses
Annually(thousands of yen)(per employee)
Number of managers

831
1,454
1,075
－
－
4,163
3,228
935
22.5%
1,369
53
3.9%
16.3%
8/49
43.4
19.5
20.1
17.3
1.7%
－
2.8%
－
－
78
1
77
－
82

Social Value Creation(Access to Medicines)

At fiscal year end

fiscal 2012 fiscal 2013 fiscal 2014 fiscal 2015 fiscal 2016 fiscal 2017 fiscal 2018 fiscal 2019 fiscal 2020 fiscal 2021
63.6%
63.6%
63.6%
63.6%
63.6%
63.6%
63.6%
63.6%
63.6%
66.7%
7/11
7/11
7/11
7/11
7/11
7/11
7/11
7/11
7/11
8/12
9.1%
9.1%
9.1%
9.1%
9.1%
9.1%
9.1%
9.1%
9.1%
8.3%
1/11
1/11
1/11
1/11
1/11
1/11
1/11
1/11
1/11
1/12
0%
4.3%
9.1%
8.0%
14.8%
11.1%
13.8%
10.0%
13.3%
13.8%
0/18
1/23
2/22
2/25
4/27
3/27
4/29
3/30
4/30
4/29
52.9
53.0
53.1
53.6
52.9
52.9
53.2
54.2
54.4
54.7
118
116
114
113
113
113
113
113
113
113
86
82
76
74
74
74
88
92
93
103
872
1,055
976
1,310
1,247
1,203
1,219
1,378
1,049
1,180
120
65
56
47
62
65
92
172
83
89
2
2
2
2
2
2
3
2
2
2
8,500
5,800
5,000
4,600
5,800
4,800
6,200
7,200
5,000
6,000
－
－
－ 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0%
28
23
28
30
34
34
34
29
16
15
3,123
2,452
2,405
5,001
5,457
5,477
5,686
6,220
5,145
5,295
fiscal 2012 fiscal 2013 fiscal 2014 fiscal 2015 fiscal 2016 fiscal 2017 fiscal 2018 fiscal 2019 fiscal 2020 fiscal 2021
10,495
10,41910,183
9,877
10,452
10,456
10,683
10,998
11,237
11,322
5,320
5,200
4,712
4,523
5,009
4,914
4,888
4,593 ☑4,613 ☑4,591
1,815
1,763
1,719
1,290
1,296
1,240
1,261
1,682 ☑1,820 ☑1,982

Social Value Creation(R&D)

Corporate Governance and Compliance
Ratio of outside directors to all directors(Outside directors/Directors)
Ratio of female directors to all directors(Female directors/Directors)
Ratio of female corporate officers to all corporate officers(Female corporate officers/Corporate officers)
Average age of corporate officers
Directors (inside) (Millions of yen)Compensation(Base compensation, bonuses
Directors (outside) (Millions of yen)
and retirement allowances)
Corporate officers (Millions of yen)
Number of times offered
Compliance training
Number of executive training courses
Total participants (approx.)
Submission rate of compliance oath
Number of times offered
Human rights training
Participants
Involvement with Employees
Total
Japan
Americas (North America)
Number of Eisai GroupEMEA (Europe, Middle East, Africa,
employees by region
Russia and Oceania)
China
Asia and Latin America
Ratio of women
Eisai group ratio of women(in management)
Ratio of women in management
Total
Male
Number of employees of
Eisai Co., Ltd.
FemaleStatus of Shares (As of March 31, 2022)(Unit: Billions of yen)fiscal 2013

fiscal 2014

fiscal 2015

fiscal 2016

fiscal 2017

fiscal 2018

fiscal 2019fiscal 2020

fiscal 2021

fiscal 2022
forecast

Revenue

599.5

548.5

547.9

539.1

600.1

642.8

695.6

645.9

756.2

700.0

Cost of sales

194.7

193.6

194.5

195.9

201.3

184.5

175.7

161.3

174.8

160.5

32.5

35.3

35.5

36.3

33.5

28.7

25.3

25.0

23.1

22.9

404.8

354.9

353.5

343.2

398.8

458.3

519.9

484.6

581.4

539.5

67.5

64.7

64.5

63.7

66.5

71.3

74.7

75.0

76.9

77.1

136.3

131.9

122.3

117.2

139.6

144.8

140.1

150.3

171.7

159.0

Financial Indicators (IFRS)〈Income Statement Items〉

Ratio to revenue (%)

Gross profit
Ratio to revenue (%)

1,100,000,000 shares
296,566,949 shares (including 9,801,133 shares of treasury stock)
74,737
Mitsubishi UFJ Trust and Banking Corporation●Principal shareholders＊Number of shares held
(in thousands)

Percentage heldof all shareholder
voting rights (%)

The Master Trust Bank of Japan, Ltd. (trust account)

57,367

20.02

Custody Bank of Japan, Ltd. (trust account)

32,906

11.48

Shareholders

24.1

22.3

21.7

23.3

22.5

20.1

23.3

22.7

22.7

State Street Bank and Trust Company 505001

18,568

6.48

194.5

192.8

174.9

183.9

228.2

256.3

281.6

366.4

339.0

Nippon Life Insurance Company

9,781

3.41

33.9

35.5

35.2

32.5

30.6

35.5

36.8

43.6

48.5

48.4

Saitama Resona Bank, Limited

6,300

2.19

4.1

1.0

17.7

13.6

3.0

2.6

6.4

1.5

14.6

13.5

The Naito Foundation

4,212

1.47

0.7

0.2

3.2

2.5

0.5

0.4

0.9

0.2

1.9

1.9

2.8

1.1

4.1

5.6

1.1

1.7

4.4

2.6

4.1

State Street Bank West Client - Treaty 505234

3,965

1.38

0.5

0.2

0.7

1.0

0.2

0.3

0.6

0.4

0.5

JPMorgan Securities Japan Co., Ltd.

3,663

1.27

66.4

28.3

51.9

59.1

77.2

86.2

125.5

51.5

53.7

−
−
55.0

Government of Norway

3,429

1.19

11.1

5.2

9.5

11.0

12.9

13.4

18.0

8.0

7.1

7.9

JPMorgan Chase Bank 385781

3,429

1.19

38.5

43.5

55.0

42.2

54.4

66.5

122.5

42.3

45.7

58.0

Ratio to revenue (%)

6.4

7.9

10.0

7.8

9.1

10.3

17.6

6.6

6.0

8.3

143,624

50.14

Profit for the year attributableto owners of the parent

38.3

43.3

54.9

39.4

51.8

63.4

121.8

41.9

48.0

57.0

Ratio to revenue (%)

6.4

7.9

10.0

7.3

8.6

9.9

17.5

6.5

6.3

8.1

Comprehensive income for the
year

84.5

114.2

16.5

36.8

53.8

79.5

96.2

70.9

90.8

−

Ratio to revenue (%)

Other income
Ratio to revenue (%)

Other expenses
Ratio to revenue (%)

Operating profit
Ratio to revenue (%)

Profit for the year

Free cash flow

●Trends in shareholder type ratio
0

6.5

3.3 3.0

Fiscal 2021

42.7

30.3

14.0

6.0

3.3 3.7

75.9

149.6

103.7

102.8

73.1

117.6

−

20.9

(18.8)(6.7)(28.6)

17.0

(7.9)

(27.6)(36.1)(28.8)−(115.1)(59.7)(72.9)(35.4)(81.9)(79.2)(103.5)(55.9)(49.0)−●Stock price trends (from April 1, 2012 to March 31, 2022)＊

87.3

61.3

81.2

81.7

136.7

85.1

68.2

36.4

88.7

−

400

■Financial institutions (Institutional investors, etc.) ■Foreign entities, etc. ■Individuals, other ■Other companies ■Treasury stock ■Financial instruments traders (securities companies)

974.0

1,030.8

1,049.0

1,071.5

1,062.1

1,088.4

1,239.3−

Equity attributable to ownersof the parent

526.3

598.7

573.7

584.6

593.6

628.1

678.1

701.6

748.8

−

Non-controlling interests

3.1

3.3

3.2

18.0

20.5

23.9

24.5

24.8

22.7

−

444.4

451.8

397.2

428.2

434.9

419.5

359.5

362.1

467.8

−

Return on equity attributable toowners of the parent (ROE) (%)

7.6

7.7

9.4

6.8

8.8

10.4

18.6

6.1

6.6

7.5

Return on sales ratio (%)

6.4

7.9

10.0

7.8

9.1

10.3

17.6

6.5

6.0

−

Leverage (times)

1.9

1.8

1.7

1.8

1.8

1.7

1.6

1.6

1.7

−

0.6

0.5

0.5

0.5

0.6

0.6

0.6

0.6

0.6

−

Ratio of equity attributable toowners of the parent (%)

54.0

56.8

58.9

56.7

56.6

58.6

63.8

64.5

60.4

−

Net debt equity ratio(Net DER)(times)＊1

0.08

0.00

(0.06)(0.11)(0.27)(0.32)(0.29)(0.27)(0.32)−

Dividend on equity attributable toowners of the parent (DOE)(%)＊2

8.5

7.6

7.3

7.4

7.3

7.0

7.0

6.6

6.3

6.1

Dividend payout ratio (DPR)(%)

111.8

99.0

78.0

109.0

82.8

67.8

37.6

109.3

95.7

−

Earnings per share (basic)(EPS) (yen)134.13151.57192.23137.63181.18221.34425.01146.95167.27

197.80

150

150

150

150

150

150

160

160

160

160

The figures for fiscal 2020 have been revised for retroactive application due to changes in accounting policies.
＊1 Net debt equity ratio (Net DER) = (Interest-bearing debt (Bonds and borrowings) – Cash and cash equivalents – Time deposits exceeding three months, etc. –Investment securities held by the parent company＊3 ) / Equity attributable to owners of the parent＊2 Dividend on equity attributable to owners of the parent (DOE) = Dividend payout ratio (DPR) x Return on equity attributable to owners of the parent (ROE)＊3 Investment securities held by the parent company are included in the formula used to calculate the liabilities ratio.

71

300
250
200
150
100
50
0
Eisai stock
price

Fiscal 2012

Fiscal 2013

Fiscal 2014

Fiscal 2015

Fiscal 2016

Fiscal 2017

Fiscal 2018

Fiscal 2019

Fiscal 2020

Fiscal 2021

HighestLowest4,405 yen
3,070 yen
4,200 yen

4,675 yen
3,600 yen
4,018 yen

9,756 yen
3,800 yen
8,535 yen

9,024 yen
6,633 yen
6,770 yen

7,338 yen
5,366 yen
5,764 yen

7,148 yen
5,402 yen
6,781 yen

11,490 yen
6,040 yen
6,213 yen

9,433 yen
5,205 yen
7,931 yen

10,900 yen
6,951 yen
7,419 yen

12,765 yen
5,442 yen
5,670 yen

Closingprice＊ The April 1, 2012, closing prices of Eisai’s stock price, average of pharmaceutical industry, and TOPIX respectively represent the 100 shown in the line graph.

●Total Shareholder Return (TSR %)＊1
Holding period
Eisai
Nikkei Stock Average＊2
TOPIX＊3

1 year

3 years
136.8
125.2
123.8

5 years
277.7
199.2
191.9

202.6
202.1
196.2

Company Information

Total assets turnover ratio(no. of times)

ー Eisai’s stock price ー Average of pharmaceutical industry ー TOPIX

Foundation forSocial Value Creation

1,053.8

（％）
100

13.1

95.6

973.8

80

30.2

76.0

Total assets

60

43.8

91.3

〈Financial Position Items〉

Dividend per share (DPS) (yen)40

Fiscal 2020

350

Total liabilities

20

Social Value Creation(Human Capital)〈Cash Flow Statement Items〉
Net cash from operating
activities
Net cash from investing
activities
Net cash from financing
activities

Total

Social Value Creation(Access to Medicines)

22.7

203.3

Ratio to revenue (%)

Selling, general andadministrative expenses＊1 Numbers of shares are rounded down to the nearest thousand.
2	Indicates the top 10 shareholders in terms of the percentage of the total number ofoutstanding shares (excluding treasury stock).
3	The 9,801,000 shares (3.30%) of treasury stock are not included in this table as they
do not have voting rights.
4	Although the following Large Shareholding Report (Revised Report) was submitted
before the end of the fiscal year, cases in which it is impossible to makeconfirmation with the shareholder registry for the end of the fiscal year, or in which
the number of shares held is not ranked among the top 10, are not included in thetable. Further, the holding percentage enclosed in parentheses is the percentage ofthe total number of outstanding shares (rounded down), including treasury stock.
a. Including the Mitsubishi UFJ Financial Group, Inc., all 4 companies jointly held
16,113,000 shares (5.43%) as of July 13, 2015 (July 21, 2015, Revised Report)b. Including BlackRock Japan Co., Ltd., all 11 companies jointly held 18,308,000
shares (6.17%) as of August 15, 2017 (August 21, 2017, Revised Report)c. Including Nomura Securities Co., Ltd., all 3 companies jointly held 18,380,000
shares (6.20%) as of July 15, 2020 (July 21, 2020, Revised Report)d. Banks’ Shareholdings Purchase Corporation held 14,945,000 shares (5.04%) as
of September 15, 2020 (September 23, 2020, Large Shareholding Report)e. Including Sumitomo Mitsui Trust Bank, Limited, all 3 companies jointly held
19,442,000 shares (6.56%) as of October 29, 2021 (November 5, 2021, Revised
Report)f. The Wellington Management Company, LLP held 23,761,000 shares (8.01%) as ofMarch 15, 2022 (March 22, 2022, Revised Report)

Social Value Creation(R&D)

Research and development
expenses

Authorized (common stock)
IssuedNumber of shareholders
Transfer agent

Management Strategies

Financial Indicators

10 years
223.4
321.3
283.3

＊1 TSR is based on investment conducted at the closing price on March 31, 2012
＊2 Source: Nikkei 225 Total Return Index
https://indexes.nikkei.co.jp/en/nkave/index/profile?idx=nk225tr＊3 Source: JAPAN EXCHANGE GROUP Monthly Statistics Reporthttps://www.jpx.co.jp/english/markets/statistics-equities/monthly/index.html

Please refer to the Notice of Resolution of the 110th Ordinary General Meeting of Shareholders for the status of shares▶ https://www.eisai.com/ir/stock/meeting/pdf/einv110_all.pdf

72

Eisai Value Creation Report 2022

Corporate Information

Corporate Data (As of March 31, 2022)
Corporate Name

Stock Exchange Listings

Eisai Co., Ltd.

Eisai common stock is listed on the Prime Market of theTokyo Stock Exchange. (Securities Code Number: 4523)

Date Founded

Date for Settlement of Accounts

December 6, 1941

March 31

Head Office Address

4-6-10, Koishikawa, Bunkyo-ku, Tokyo 112-8088, Japan

Annual Shareholders’ Meeting
Held in June

Paid-in Capital¥44,986 million

Independent Public Accountants
Deloitte Touche Tohmatsu LLC

Major External Evaluations (As of July 2022)

FTSE Russell (the trading name of FTSE International Limited and Frank Russell Company) confirms that Eisai Co., Ltd. has been independently assessed according to the
FTSE4Good criteria, and has satisfied the requirements to become a constituent of the FTSE4Good Index Series. Created by the global index provider FTSE Russell, theFTSE4Good Index Series is designed to measure the performance of companies demonstrating strong Environmental, Social and Governance (ESG) practices. The FTSE4Good
indices are used by a wide variety of market participants to create and assess responsible investment funds and other products. https://www.ftserussell.com/products/indices/
ftse4good
FTSE Russell (the trading name of FTSE International Limited and Frank Russell Company) confirms that Eisai Co., Ltd. has been independently assessed according to the
FTSE4Good criteria, and has satisfied the requirements to become a constituent of the FTSE Blossom Japan Sector Relative Index. Created by the global index provider FTSE
Russell, the FTSE4Good Index Series is designed to measure the performance of companies demonstrating strong Environmental, Social and Governance (ESG) practices. The
FTSE4Good indices are used by a wide variety of market participants to create and assess responsible investment funds and other products.
In 2022, Eisai Co., Ltd. received a rating of AA (on a scale of AAACCC) in the MSCI ESG Ratings assessment.
THE USE BY Eisai Co., Ltd. OF ANY MSCI ESG RESEARCH LLC OR ITS AFFILIATES (“MSCI”) DATA, AND THE USE OF MSCI LOGOS, TRADEMARKS, SERVICE MARKS OR
INDEX NAMES HEREIN, DO NOT CONSTITUTE A SPONSORSHIP, ENDORSEMENT, RECOMMENDATION, OR PROMOTION OF Eisai Co., Ltd. BY MSCI. MSCI SERVICES
AND DATA ARE THE PROPERTY OF MSCI OR ITS INFORMATION PROVIDERS, AND ARE PROVIDED ‘AS-IS’ AND WITHOUT WARRANTY. MSCI NAMES AND LOGOS ARE
TRADEMARKS OR SERVICE MARKS OF MSCI.
THE INCLUSION OF Eisai Co., Ltd. IN ANY MSCI INDEX, AND THE USE OF MSCI LOGOS, TRADEMARKS, SERVICE MARKS OR INDEX NAMES HEREIN, DO NOTCONSTITUTE A SPONSORSHIP, ENDORSEMENT OR PROMOTION OF Eisai Co., Ltd. BY MSCI OR ANY OF ITS AFFILIATES. THE MSCI INDEXES ARE THE EXCLUSIVEPROPERTY OF MSCI. MSCI AND THE MSCI INDEX NAMES AND LOGOS ARE TRADEMARKS OR SERVICE MARKS OF MSCI OR ITS AFFILIATES.

Investor Relations
Eisai Co., Ltd.
4-6-10, Koishikawa, Bunkyo-ku, Tokyo 112-8088, Japan
https://www.eisai.com

73