For the Year Ended March 31, 2022
Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Turn innovative science into VALUE
for patients
Since Astellas was established in 2005, the Company has
strived to continue to create innovation and deliver
innovative medical solutions that meet the needs of patients.
Going forward, we are committed to achieving our VISION of
tuning innovative science into VALUE for patients.
In the future as well, Astellas aims to stand on the forefront
of healthcare change to turn innovative science into VALUE
for patients and will continually strive to fulfill the
expectations of our stakeholders and society.
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Astellas At a Glance
Total sales revenue
Sales of Major Products
Sales revenue by region
¥1,296.2 billion
Core operating profit
¥244.7 billion
enzalutamide / XTANDI
for the treatment of
prostate cancer
enfortumab vedotin /
PADCEV for the treatment of
urothelial cancer
gilteritinib / XOSPATA
for the treatment of acute
myeloid leukemia
mirabegron*1 for the
treatment of overactive
bladder
tacrolimus / Prograf*2
immunosuppressant
¥534.3 billion
¥ 21.7 billion
¥34.1 billion
¥172.3 billion
¥185.4 billion
(For the year ended March 2022)
(For the year ended March 2022)
¥66.3 billion / 5.1% ¥8.4 billion / 0.6%
Others
Greater China*5
¥110.1 billion / 8.5%
International Markets*4
¥258.8 billion
/ 20.0%
Japan
Total
¥1,296.2
billion
¥537.5 billion
/ 41.5%
United States
¥315.2 billion
/ 24.3%
Established Markets*3
(For the year ended March 2022)
R&D expenses
RX: Prescription drug
Major pipeline
Overseas
employee ratio
10.0%
International
Markets*4
8.1%
Greater China*5
¥246.0 billion
24
(Number of Programs)
About 66%
24.0%
United States
Employee ratio
per region
34.1%
Japan
23.8 %
Established Markets*3
(For the year ended March 2022)
(As of July 31, 2022)
(As of July 31, 2022)
*4 International Markets: Russia, Latin America, Middle East, Africa, Southeast Asia, South Asia, Korea, Export sales, etc.
*1 Betanis, Myrbetriq, Betmiga
*2 Including Advagraf, Graceptor, ASTAGRAF XL
*3 Established markets: Europe, Canada, Australia
*5 Greater China: China, Hong Kong, Taiwan
01
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Astellas At a Glance
Global Network
As a global pharmaceutical company, we are currently working in over 70 countries
Established Markets
United States
Astellas Pharma Ireland Co.,
Limited Dublin Plant
Astellas Pharma Ireland Co.,
Limited Kerry Plant
Astellas Pharma
Global Development, Inc.
Mitobridge, Inc.
Astellas Innovation
Management LLC (Boston office)
Astellas Institute for
Regenerative Medicine (AIRM)
Astellas Gene Therapies
(Sanford)
Astellas Pharma
Europe B.V.
Meppel Plant
International Markets
Astellas Pharma China, Inc.
Shenyang Plant
Japan
Toyama Technology Center
Takaoka Plant
Astellas Innovation Management
LLC
（Cambridge UK office）
Nanna Therapeutics Limited
Greater China
Astellas China
Investment Co.,
Limited
Yaizu Technology
Center
Yaizu Pharmaceutical
Research Center
Takahagi Technology
Center
Takahagi Chemistry &
Technology Development Center
Tsukuba Research Center
Tsukuba Biotechnology
Research Center
Headquarters (Tokyo)
Universal Cells, Inc.
Iota Biosciences, Inc.
Astellas Gene Therapies
Astellas Venture
Management LLC
(San Francisco office)
Astellas Rx+ Business
Accelerator, LLC
Astellas Innovation
Management LLC
(San Francisco office)
Xyphos Biosciences, Inc.
Headquarters
R&D bases
Manufacturing Bases
Corporate Venture Capital
02
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Our Philosophy and VISION
Guided by our business philosophy, we are committed to the realization of greater VALUE by patients and
healthcare systems around the world.
Philosophy
Raison D’être
Contribute toward improving the health of
people around the world through the provision of
innovative and reliable pharmaceutical products
Mission
Sustainable enhancement of enterprise value
Beliefs
Our “beliefs” provide the code of conduct we prize
at all times. Astellas will always be a group of
people who act upon these beliefs.
High Sense of Ethics
Creativity
Customer Focus
Competitive Focus
On the forefront of healthcare
change to turn innovative
science into VALUE for patients
03
VISIONAstellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
CONTENTS
Message
Astellas At a Glance
Our Philosophy and VISION
Contents/Editing Policy
Statement of Responsibility
Strategic Goal 3
Message from the Head of
the Rx+ Business Accelerator
Progress of Strategic Goal 3
01
03
04
05
Interview with Chief Executive Officer
06
Value Creation Story
Value Creation Model
Our History
Management Capital
Astellas’ Business Model for Creating Innovation
Strengthening Our Sustainability
by Revising the Materiality Matrix
The VALUE that Astellas Provides
Providing Value to Stakeholders
11
12
14
15
16
17
21
22
Strategic Goal 4
Message from the Head of the Sustainability Division
Progress of Strategic Goal 4
Organizational Health Goals
Message from the Head of Human Resources
People and Organization for Innovation
Initiatives for People and Organization
Organizational Health Goals
Engagement, Diversity, Equity and Inclusion
Strengthening Governance
Board of Directors
Corporate Governance
Progress of Corporate Strategic Plan
23
Interview with an Outside Director
Corporate Strategic Plan Review
Corporate Strategic Plan 2021
Interview with Chief Strategy Officer
Interview with Chief Financial Officer
Strategic Goal 1
Message from Chief Commercial Officer
Progress of Strategic Goal 1
Strategic Goal 2
Message from Chief Scientific Officer
Progress of Strategic Goal 2
Digital Transformation
24
25
28
31
34
35
36
39
40
41
45
Risk Management
Ethics & Compliance
Corporate Data
Major Pipeline
Financial Data
Non-financial Data
Company Overview
04
46
47
48
50
51
52
58
59
61
62
63
65
66
67
69
76
78
80
82
83
86
89
91
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Scope of the Report
Period covered: Fiscal year ended March 2022 (April 1, 2021 - March 31, 2022)
As much as possible, we have included the latest information available at
the time of publication.
The period and scope of coverage may vary depending on the subject.
We have noted each such case individually.
Organizations covered: Astellas Pharma Inc. and its consolidated subsidiaries
in Japan and overseas (referred to in this report as “Astellas”)
Disclaimer
In this integrated report, statements made with respect to current plans, estimates,
strategies and beliefs, and other statements that are not historical facts are
forward-looking statements about the future performance of Astellas Pharma.
These statements are based on the management’s current assumptions and
beliefs in light of the information currently available to it and involve known
and unknown risks and uncertainties. A number of factors could cause actual
results to differ materially from those discussed.
Information about pharmaceutical products (including products currently in
development) which is included in this integrated report is not intended to
constitute an advertisement or medical advice.
Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Statement of Responsibility
Kenji Yasukawa
Representative Director, President and CEO,
Chairman of the Board
05
In May 2021, Astellas announced its Corporate Strategic Plan 2021 (CSP2021) for realizing its VISION “On the forefront of healthcare change to turn innovative science into VALUE for patients”. Since the launch of CSP2021, we have been promoting initiatives aligned to the plan, and steadily achieving its goals. Integrated Report 2022 reports on the progress of CSP2021. The financial and non-financial information provided is intended to provide an understanding of Astellas' path to sustainable growth and value creation. The report includes an overview of our updated materiality, which is essential for realizing VISION. In preparing this report, we referred to the International Integrated Reporting Framework by the IFRS Foundation and the Guidance for Integrated Corporate Disclosure and Company-Investor Dialogues for Collaborative Value Creation by the Ministry of Economy, Trade and Industry. For ESG information, we also referred to the Ministry of the Environment's Environmental Reporting Guidelines (FY2018 version), the Global Reporting Initiative's Sustainability Reporting Standards, and the final report of the Task Force on Climate-related Financial Disclosures (TCFD). Divisions across Astellas collaborated to prepare this report. I hereby represent that the creating process and its contents are valid, and that it has been prepared based on the current situation and the future for which we strive. We hope that this report will help you further understand Astellas' story of value creation, which is directed toward the realization of our VISION. We also hope that it will help to enrich our dialogue with our stakeholders.Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Interview with Chief Executive Officer
We will take on the challenge of creating
innovative products, delivering Astellas’
unique VALUE to patients.
Q
A
Please tell us about Corporate Strategic Plan 2021 (CSP2021). What are its aims and
how is it different from Corporate Strategic Plan 2018 (CSP2018)?
CSP2021 is a phase for steadily carrying out our Focus Area approach and
linking it to results.
CSP2018 was a phase for exploring and confirming the effectivity our new business model. We moved
away from our old business model of creating products with a focus on specific disease areas. For the
first time, we introduced the Focus Area approach into our strategy. The idea of the Focus Area
approach is to take in a range of perspectives as we map out areas for research and development.
We explore areas where the biology that causes a disease is clear, aiming to fulfill unmet medical
needs in 10 to 15 years from now. We efficiently identify drug discovery opportunities by flexibly
choosing the best modalities/technologies for the biologies. In CSP2018, we worked to expand our
Focus Area approach on several fronts. We increased the number of development projects in several
Primary Focuses, which carry out strategic research and development investments within each Focus
Area. As these Primary Focuses began to connect with each other to generate new Primary Focus
candidates, we could see that our Focus Area approach was sound.
Meanwhile, developed countries have worked to curb healthcare costs by promoting generic
drugs, it became difficult for pharmaceutical manufacturers to earn sustainable profits from a single
product after the patent expired, resulting in their need to create new drugs continuously.
06
Kenji Yasukawa
Representative Director, President and CEO,
Chairman of the Board
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Interview with Chief Executive Officer
The 3-year period of CSP2018 was a time when this point became decisive. Pharmaceutical com-
panies now face a choice between being a new drug development company or a generic company.
At Astellas, we decided to pivot quickly away from the traditional business model, divested 16 off-pat-
ent products to other pharmaceutical companies and shifted to our Focus Area approach.
Q
A
In these times, what role should Astellas play in society?
Our role is to deliver the unique VALUE of Astellas. We need to be
an innovative company that sets an example for a new era.
The Astellas business is undergoing a transformation. We are breaking away from the strategy of
competing for markets that have many similar products. We are instead focusing our business on
delivering highly unique and innovative products. Our strategic products, which began with XTANDI
and later expanded with products such as XOSPATA and PADCEV, are truly unique to Astellas. Under our
Focus Area approach, we are also carrying out research and development in the areas of cell therapy,
gene therapy, and immuno-oncology. Through these efforts, we expect to create products that are
even more unique and innovative. Continuing to provide unique VALUE to society in this way is the
most important role for Astellas. That is why Astellas must be an innovative company. My biggest focus
right now is on tackling our Organizational Health Goals (OHGs) for becoming an innovative company.
One example is revising our job-based compensation system. Firstly, we integrated the HR system
globally which was different by each region. Then we globally integrated the job grades and remuner-
ation systems and promoted the development of a system that determines grades and remuneration
depending on the job. The system is based on globally unified standards regardless of the organization
to which the person belongs or the country/region where he or she works.
We also put in place a job posting system that is shared globally. This allows employees to apply for
positions within the Company regardless of where they sit in the organization or in the world. We will
use this as a way of making sure that we can place the right person in the right position. This system has
had a very strong response. By our latest count,* we had more than 500 applicants for over 20 divisions.
Through measures like this, we can become an innovative company that sets an example for a new era.
I see that as one of the roles of Astellas.
* Aggregate results for the first quarter of FY2022
07
Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Interview with Chief Executive Officer
Q
A
What were the key processes for drawing up CSP2021 and how will we be able to
carry out such bold measures for organizational transformation?
After interviewing employees around the world, we realized that we needed
a strong commitment to clearing away obstacles to innovation.
To develop CSP2021, we held interviews with employees around the world over a 6-month timeframe
starting in the spring of 2020. We analyzed hundreds of responses to the question, “What is holding
Astellas back from innovation?” The most troubling obstacle we found was that our organization as a
whole was too conservative and too afraid of failure to be able to take on new challenges. Other
issues that were highlighted included challenges toward new goals were not appreciated and that the
role of leadership in executing ideas was unclear.
There needs to be the right level of collaboration between various departments, such as research,
development, manufacturing, and commercial. Only then can innovation emerge. However, we
also found opportunities to improve our evaluation system and organizational structure. For example,
our previous system involved setting goals for each department and evaluating them on a
department-by-department basis. This hindered cross-departmental collaboration and meant that
employees were not incentivized to achieve more ambitious goals.
We had to tackle these challenges head-on. Overcoming them will change us into a more innovative
organization and better position us to deliver on our Strategic Goals. To this end, we have positioned
our set of OHGs as one of the major goals of CSP2021.
Our OHGs consist of 3 types of goals.
The first OHG is “Brave ideas pursue ambitious outcomes.” To achieve this we need a corporate
culture that encourages taking on challenges without fear of failures. We need a psychologically safe
environment that allows for learning from intelligent failures. To support this, we introduced an
evaluation system that encourages departments and individuals to set ambitious goals.
The second goal is “Talent and leadership thrives.” We are actively carrying out training to change
the mindset and style of employees in leadership positions, who are key to enabling our people to
thrive in their work. Specifically, we created the Astellas Leadership Expectations and provided training
to approximately 3,000 leaders.
The third goal is “We excel as one Astellas.” To support this goal, we introduced the Shared
Objectives system for promoting cross-functional cooperation, collaboration, and coordination as
“One Astellas.” As part of our review of the evaluation system, we aligned our individual bonus
system to company-wide performance rather than the performance of the department.
08
Process for transformation into an innovative organization
Identified Issues
Goals
• Extensive fear of failure and
unwillingness to take
business risks to achieve
innovation
• Conservative objective
setting
• Reluctance to update or
develop new systems and
processes
Organizational Health Goal 1
“Brave ideas pursue ambitious
outcomes”
Aggressively take on challenges for
innovation and ambitious outcomes
Initiatives for Organizational
Health Goal 1, e.g.
Culture
development
with
psychological
safety
• Lack of clarity about the
leadership style needed to
generate innovative ideas
• Lack of development plans
to foster leadership
Organizational Health Goal 2
Initiatives for Organizational
Health Goal 2, e.g.
“Talent and leadership thrives”
Environment in which excellent people
have ownership and demonstrate
leadership
Astellas
Leadership
Expectations
• Evaluation system that
promotes optimization of
divisions
• Silo situation and lack of
trust between divisions
Organizational Health Goal 3
Initiatives for Organizational
組織健全性目標3
Health Goal 3, e.g.
“We excel as One Astellas”
Collaborate across divisions to achieve
shared goals for all Astellas
Shared
Objectives
Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Interview with Chief Executive Officer
Performance Goals of CSP2021
FY2025
Stock market
capitalization:
7trillion yen
1 XTANDI and Strategic products: ≥¥1.2T in FY2025
2 Focus Area projects: ≥¥0.5T in FY2030
3 Core OP margin of ≥30% in FY2025
≥¥0.5T
3
Focus
Area
projects
≥¥1.2T
1
Strategic
products
XTANDI
CoGs
XTANDI
Co-Pro
SG&A
R&D
Q
A
What kind of people will support Astellas in the future?
The people who will support Astellas in the future are those who
understand the true intentions of the OHGs. They embrace challenges
while improving their individual capabilities.
I think of the individual capabilities of our employees to be like the letter T of the alphabet. The vertical
bar of the T stands for expertise. It is important for employees to have a core area of expertise of their
own. After building a career around that expertise, we can advance our understanding of the overall
pharmaceutical value chain and extend our capabilities like the horizontal bar of a T. The letter T can
take many forms. Some employees have a long vertical axis. Some have a long horizontal axis. Others
have 2 vertical axes like the Greek letter π (pi). I believe that by placing a wide range of people in the
right places we can energize and strengthen our organization.
We expect all employees to understand the intent of the OHGs, and not just superficially, but
thoroughly. All of these goals align with our aim for Astellas to become an innovative company. The
psychological safety I mentioned is not about trying to create a friendly company. On the contrary, we
want to create a culture where supervisors do not put the brakes on various challenges, so that will
actually take more effort from employees. We want all of our employees to embrace challenges based
on an understanding of the true intentions of the OHGs. I believe that the people who can do that are
the ones who will support the future of Astellas.
Core OP
2
≥30%
Sales by Products
P&L
Sales by Products
P&L
FY2025
FY2030
Q
A
Looking back at FY2021, what are your thoughts on the year
from a business perspective?
Although some factors such as the weak yen had a temporary impact,
our first year of CSP2021 has got off to a good start.
The first year of CSP2021 was a phase of preparation for achieving our goals. This involved some cost as
we made upfront investments in areas such as promoting the OHGs and building our global system. In
addition, the yen weakened just prior to the fiscal year-end. This had a temporary negative effect on
the P/L before the benefits of the weaker yen could emerge. As a result, we recorded sales growth but
decrease in core operating profit. In the fourth quarter, Russia's invasion of Ukraine triggered inflation
that impacted overseas sales. Furthermore, for economic reasons, self-insured health plans in countries
such as the US prioritized low cost even in the treatment of serious diseases such as cancer. This meant
09
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Interview with Chief Executive Officer
that we were unable to achieve the revenue we had forecast at the beginning of the fiscal year. However,
these developments mostly relate to temporary factors. The fundamentals of our business have not
been negatively affected, so I believe we have made a good start.
On the other hand, during FY2021, COVID-19-related delays were a cause for concern. These affected
some development, namely projects in the early stages of clinical trials. Projects in the later stages of
clinical trials are moving ahead largely as planned. This is because early-stage clinical trials are susceptible
to the impact of hospital staffing shortages and patient visitation restrictions caused by COVID-19.
However, that situation is gradually recovering. We expect progress in FY2022 to be on schedule.
Q
A
Lastly, do you have a message for shareholders and investors?
We aim to achieve performance goals through the implementation of strategic
goals and organizational health goals which we have set in CSP2021. As a result,
we expect to be recognized as a company with a market capitalization of 7 trillion
yen. Please look forward to our research and development progress.
In CSP2021, we have set performance targets consisting of 3 goals: “Revenue: At least 1.2 trillion yen in
sales of XTANDI and key strategic products* in fiscal year 2025. Pipeline value: Expected sales from Focus
Area assets of more than 500 billion yen in fiscal year 2030. Core operating margin: More than 30% core
operating profit margin in fiscal year 2025”. We will be able to achieve performance goals when the strate-
gic goals and organizational health goals are achieved. And when we achieve our performance goals, we
believe that we will be evaluated by the stock market with a market capitalization of 7 trillion yen.
The important point is how many flagship products we can develop. It is still in the early research
stage, but it will support the next generation of Astellas.
Our challenge is not in an area where we can know the probability of success, and it is hard to
perfectly predict in which areas we will be able to create new products. Still, we are confident that our
Focus Area approach will bear fruit and create VALUE. This performance target becomes achievable
when the strategic target and organizational health target are achieved in the near future.
We are committed to creating innovative medicines in areas such as cell therapy and gene therapy,
where there are very few precedents. Until a new drug is approved, it must pass through many gates
and meet many requirements. No one can tell it how to do that. We are working toward our VISION, to
be on the forefront of healthcare change to turn innovative science into VALUE for patients. Delivering
on that will not be easy, but Astellas will keep pushing. We appreciate your continued support.
10
Representative Director,
President and CEO,
Chairman of the Board
Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Value Creation Story
CONTENTS
Value Creation Story
Value Creation Model
Our History
Management Capital
Astellas’ Business Model for Creating Innovation
Strengthening Our Sustainability
by Revising the Materiality Matrix
The VALUE that Astellas Provides
Providing Value to Stakeholders
11
12
14
15
16
17
21
22
11
1111
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Value Creation Model
Based on our business philosophy to “Contribute towards
improving the health of people around the world through the
provision of innovative and reliable pharmaceutical products,”
Astellas is striving to continue to create innovation and deliver
innovative medical solutions that meet the needs of patients.
Philosophy
Raison D’être
Mission
Beliefs
Social issues and
requests from society
Solving social issues
VISION
P.03
Output
Key Issues and Materiality
P.17
XTANDI and Priority Strategic Products
Input
Financial Capital
Invested capital
Flexible financing for business opportunities
Manufacturing Capital
Research facilities
Manufacturing facilities covering commercial production
of cell and gene therapies
Intellectual Capital
Patents
Know-how for global drug development and
commercialization
Technical capabilities for various new modalities
Social and Relational Capital
Corporate brand
Collaboration / alliance
Human network
Human Capital
Highly skilled talent
DE&I
Natural Capital
Natural resources
Reusable energy
Biodiversity
Business Activity
Business Model
Fulfill the unmet medical needs by creating and delivering innovative treatments
Cutting-edge, VALUE-driven life sciences innovator
P.16
“VALUE Creation”
through research and development activities
“VALUE Realization” through later stage
development and commercialization activities
Strategy
Corporate Strategic Plan 2021 accelerating realization of VISION
P.25
Strategic Goals
1 Enable patients to achieve better
2 Translate innovative science into proven
outcomes
VALUE
3 Advance the Rx+ Business
4 Deepen our engagement in sustainability
Environment where diverse individuals
can success
“Right person in right position” globally
Organizational Health Goals
1 Brave ideas pursue ambitious outcomes
3 We excel as one Astellas
2 Talent and leadership thrives
Talent and
Organization
which Create
Innovation
Governance
P.15
P.66
P.36
Products derived from FA approaches,
including cell medicine and gene therapy
Rx+® Healthcare Solutions
P.43
P.48
Outcome
Maximize VALUE
P.21
Common Definition of
VALUE
VALUE =
Outcomes
that matter to patients
Cost to the
healthcare system of
delivering those
outcomes
Performance
成果目標
Goals
P.25
P.××
12
13
Impact
Enhance sustainability of
society and Astellas
Realization of
sustainable society
Providing value
to stakeholders
P.22
Sustainable
enhancement of
enterprise value
Earning trust
from stakeholders
Enhancing management capital Primary Focus • Genetic Regulation• Blindness and Regeneration• Mitochondria• Immuno-Oncology• ASP5354: Visualization of the urethra in operations• Wireless medical implantable devices• Digital therapeutics• ECG analysis service• Exercise support serviceCorporate Governance, Risk Management, ComplianceAstellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Our History
Shifts in the Corporate Strategic Plan and strategic areas
Our VISION is updated in CSP2015
CSP2018
CSP2021
Global Category Leader (GCL) model
2005–2010
Urological disease,
transplant fields
From 2010
onwards
Urological disease, transplant
fields, oncology platform
Focus Area Approach
P.41
Apr. 2005
2010
2015
2018
2021
Astellas Pharma Inc. was established
Dec. 2007
Astellas acquired
Agensys, Inc.
Acquisition of antibody-
drug conjugate
Entered field of cancer biology
Sept. 2012
Astellas launched XTANDI
Target disease: Prostate
cancer
June 2010
Astellas acquired OSI Pharmaceuticals, Inc.
Created an oncology platform in the US
Given major changes in the healthcare industry
environment, Astellas is conducting its research activities
while incorporating cutting-edge science from outside the
Company, and continuously creates new valuable drugs.
Astellas will continue to work on Focus Areas, where we
have a competitive advantage, and turn innovative science
into VALUE for patients.
Dec. 2019
Astellas launched PADCEV
Target disease: Urothelial cancer
Dec. 2018
Astellas launched XOSPATA
Target disease:
Acute myeloid leukemia
Dec. 2016
Astellas acquired Ganymed Pharmaceuticals AG
Acquisition of late-stage product zolbetuximab
Nov. 2019
Target disease: stomach cancer, etc.
Astellas launched Evrenzo
Target disease: Renal anemia
2023
Plan to apply for
zolbetuximab
May 2017
Astellas acquired Ogeda SA
Aug. 2022
US FDA accepts application
Acquisition of late-stage product fezolinetant
Target disease: Vasomotor symptoms associated with menopause
for fezolinetant
Entered cell therapy platform
Feb. 2016
Dec. 2019
Astellas acquired Ocata Therapeutics, Inc.*
Acquisition of pipeline and leading-
edge core technology position in
ophthalmology and cell therapy
Astellas acquired Xyphos Biosciences, Inc.
Acquisition of next-generation cancer
immunotherapy technology
* Renamed Astellas Institute
for Regenerative Medicine
Feb. 2018
Astellas acquired Universal Cells, Inc.
Acquisition of universal donor cell technology
Entered genetic regulation platform
Jan. 2020
Astellas acquired Audentes Therapeutics, Inc.
Acquisition of a foundation in adeno-associated
virus (AAV)-based gene therapy (AT132, AT845)
Launched Rx+ business
Oct. 2020
Astellas acquired Iota Biosciences, Inc.
Acquisition of unique bioelectronics technology
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Corporate Data
Management Capital
The capital that Astellas has accumulated along with its steady growth is essential for enhancing the sustainability of society and of Astellas. We will promote corporate activi-
ties that use financial capital, manufacturing capital, intellectual capital, social and relational capital, human capital, and natural capital. By further strengthening these capitals,
we will realize a sustainable society and sustainable enhancement of our enterprise value.
Financial Capital
Invested capital
Flexible financing for business opportunities
Social and
Relational Capital
Corporate brand
Human network
Collaboration / alliance
While maintaining a sound financial position, our top priority
is investment for future business growth. We will be agile in
our financing for business opportunities.
We are promoting our business by leveraging the following: our
corporate brand of running our business globally through
innovative and reliable pharmaceutical products, a broad human
network of our individual employees active in various specialized
fields, and proactive and effective collaboration and alliances
with various business partners, such as open innovation.
Manufacturing
Capital
Research facilities
Manufacturing facilities covering commercial production of cell
and gene therapies
Human Capital
Highly skilled talent
DE&I
We have state-of-the-art in-house research facilities and
manufacturing facilities covering commercial production of
cell therapy and gene therapy. These are necessary for
creating innovative new drugs and healthcare solutions, and
we are expanding our business globally.
We drive innovation and create new value through the activities
of our highly skilled employees. We empower diverse people to
contribute to our business using their specialized knowledge
and skills, regardless of their race, nationality, gender, age, or
other attributes.
Intellectual
Capital
Patents
Know-how for global drug development and commercialization
Technical capabilities for various new modalities
Natural Capital
Natural resources
Reusable energy
Biodiversity
We possess not only patents related to our products, but also
intellectual capital that sustains our competitive strength. This
takes the form of know-how for global new drug development
and commercialization, and technical capabilities for various
new modalities.
15
We use this capital in our business activities while taking steps
to improve environmental sustainability. This includes using
natural resources effectively, using reusable energy, and working
to maintain and preserve biodiversity.
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
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Strengthening Governance
Corporate Data
Astellas’ Business Model for Creating Innovation
At Astellas, we are relentless in our pursuit of innovative science and in identifying
unmet medical needs by monitoring changes in healthcare from multiple perspectives.
We are achieving VALUE creation and realization for patients through development of
innovative new drugs and healthcare solutions, and enhancement of patient access to
healthcare and outcomes around the world by leveraging our strengths.
Business Model
Fulfill the unmet medical needs by creating and delivering innovative treatments
Cutting-edge, VALUE-driven life science innovator
This is the simplest answer to the question: “who do we want to be?”. Created in parallel with the 5 year
CSP2021, the “Mature State” description of Astellas is an evolving, longer-term image of the Company we
expect to become as we strive to realize our VISION. We have distilled the sentiment of the Mature State
into 1 phrase and it should be understood as follows:
– Cutting-edge:
We operate at the forefront of scientific and technological advances to create novel healthcare solutions.
– VALUE-driven:
Our common definition of VALUE means that everything we think and do is informed by what leads to
more and better outcomes that matter to patients.
– Life sciences innovator:
We leverage and evolve our capabilities to exploit the greatest opportunities across the prescription
biopharmaceutical business and beyond, and then continuously bring innovation to life.
“VALUE Creation”
through research and development activities
“VALUE Realization”
through later stage development and
commercialization activities
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Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
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Strengthening Governance
Corporate Data
Strengthening Our Sustainability by Revising the Materiality Matrix
New Materiality Matrix
To prepare the new materiality matrix in FY2021, Astellas selected 19 key issues from the
perspective of importance for both society and Astellas in sustainability. We then prioritized
the 9 material issues (Materiality) from this group. As we believe that the act of prioritizing
h
g
i
h
y
r
e
v
e
B
and subsequently addressing these 9 material issues will put Astellas on the path to becoming
a cutting-edge, VALUE-driven life science innovator with enhanced our business activities
meeting expectations from society. This, in turn, will lead to improved sustainability for both
Reduction of
environmental burden
Talent and organizational
culture for realizing innovation
Responsible supply chain
management
Access to Health
Compliance and ethical
business practices
Product quality assurance
and product safety
Astellas and society.
VOICE
In FY2021, the materiality matrix was revised on a cross-divisional basis, and I led the entire
process. In the previous materiality assessment (FY2017), many issues were positioned as the
most important, and we received suggestions from external stakeholders that they were too
generalized and difficult to understand.
In the assessment for FY2021, we took a different approach than in FY2017 in order to narrow
down the issues from a more objective perspective and to ensure that Astellas’ unique character-
istics are reflected in the assessment results. For the weighting of “Societal Significance” on the
vertical axis, we determined priorities by combining the magnitude of the social issues and the
level of interests from stakeholders. Furthermore, in weighting the “Significance to Astellas” on the
horizontal axis, we also added the perspective of whether Astellas’ assets and capabilities can be
used to address the issues. Obviously, we collected input from many internal and external
stakeholders as we proceeded with the revision. Internally, the Sustainability Advisory Panel, the
Biodiversity
Climate change and energy
DE&I
(Diversity, Equity & inclusion)
e
c
n
a
c
i
f
i
n
g
i
s
l
a
t
e
i
c
o
S
Fulfilling unmet medical
needs by creating novel
healthcare solutions
Safe and appropriate
use of products
Transformative treatment
through innovative
therapeutic methods
Value-based pricing
Animal welfare
Data governance
Advocacy
Digital transformation
Patient centricity
Responsible R&D
Executive Committee, the Board of Directors, and other
committees actively discussed this materiality matrix.
The revised materiality matrix has narrowed down the
number of issues and made it clear which issues
Astellas should address. As a result, many stake-
holders have commented that it has become a
materiality matrix that is unique to Astellas.
h
g
H
i
High
Sayaka Konishi
Sustainability
Significance for Astellas
Important
Very Important
Most Important
Be very high
Click here to learn more about the definitions of the key issues (PDF)
https://www.astellas.com/system/files/definition_of_key_issues_en_2022_0.pdf
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Corporate Data
Strengthening Our Sustainability by Revising the Materiality Matrix
Process of Updating the Materiality Matrix
Astellas revised its materiality matrix in FY2021 to reflect changes in the internal and external environment in the steps shown below. Under the VISION “On the forefront of
healthcare change to turn innovative science into VALUE for patients,” we have developed specific action plans and started implementation to drive our efforts to address the key
issues identified in the materiality matrix.
STEP
01
Issue identification
STEP
02
Issue prioritization
STEP
03
Review and finalization
Astellas identifies key issues referring to SDGs and
Astellas developed the materiality matrix by
The draft materiality matrix was refined and validated
various frameworks (IIRC, SASB and GRI standard, ISO
prioritizing the identified key issues from the
through the information provided by, and a series of
26000 the UN Global Compact’s 10 principles, TCFD
perspectives of significance to society and Astellas.
interviews with various stakeholders including
recommendation), stakeholder engagement informa-
Societal Significance, the vertical axis of the
institutional investors, industry associations, NPOs,
tion, and topics covered by ESG ratings.
matrix, was determined by considering the depth of
and NGOs. The Sustainability Advisory Panel,
In updating a materiality matrix in FY2021, we
interest from global stakeholders—multinational
consisting of cross-functional Astellas employees,
surveyed the shifts in sustainability trends since
organizations, governments, NGOs, investors, and
held further discussions before the Executive
FY2017—the year of the previous matrix update, we
industry associations—and the scale of economic
Committee reviewed and deliberated the findings,
ensured alignment with Corporate Strategic Plan
losses caused by social issues. Significance for
and the materiality matrix was finally approved by
2021 as well as acknowledging the industry-specific
Astellas, the horizontal axis, was determined by
the Board of Directors.
issues we must address as a pharmaceutical company.
assessing not only risks but also Astellas’ degree of
The materiality matrix is reviewed and verified by
As a result, a list of 19 key issues has been identified.
opportunity in utilizing its capabilities and assets to
the Sustainability Division annually and will be
Viewpoints for identifying key issues
#1 Alignment with CSP2021
#2 Shifts in sustainability trends
#3 Industry-specific issues we must address as a pharma-
ceutical company
contribute to the resolution of issues and added
updated as necessary. Astellas has set targets and
management perspectives based on interviews with
action plans to ensure addressing the material issues.
top management.
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Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
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Strengthening Our Sustainability by Revising the Materiality Matrix
Addressing the 9 most important issues, Astellas will transform to be a VALUE-driven life science innovator, and expand its level of trust as an industry leader.
Transforming to be
a cutting-edge,
VALUE-driven life
science innovator
There are patients and their families suffering from diseases with no or limited treatment options that cannot provide
satisfactory outcomes in society.
Astellas is pursuing transformative healthcare solutions that do not simply alleviate the symptoms of diseases. Instead, we are
developing innovative therapeutics, such as cell therapies and gene therapies, which are disease-modifying and directly address
the underlying cause of the disease. Symptomatic treatment not only places a burden on the patient through commuting to the
hospital and inpatient stays, but also increases the burden on their families who nurse and care for them as the social and
economic losses are not small. By actively creating innovative treatment measures, Astellas aims to free patients and their
families from years of treatment and care, while significantly improving symptoms with only a few treatment cycles. As a result,
patients can return to their normal lives sooner, thereby reducing the overall load on the local healthcare system far and wide
from the constant need for medical treatment.
We believe that one of the most important driving forces to create and deliver great VALUE to society is an organizational
culture that realizes innovation. Astellas will continue our endeavor to cultivate an organizational culture and achieve sustain-
able value creation through acquiring and developing talent in order to provide the access to healthcare solutions we have
created to as many patients as possible. In addition, in order to sustainably create innovative therapeutic approaches and other
innovations, it is necessary to set appropriate prices for innovations. Astellas will also cultivate an environment and scheme to
ensure that prices fairly reflect the value impact on society, including patients, their families, and the healthcare professionals
who support patients' health.
Material issues to realize the above
Fulfilling unmet medical needs by creating novel healthcare solutions
Addressing advanced and hard-to-treat diseases and conditions with a high level of unmet medical needs through
Talent and organizational culture for realizing innovation
Ensuring talent and an organizational culture that contribute to generating innovation through attraction, retention
novel therapeutic molecules and delivery methods, as well as new technologies for disease management—such as
and organizational/talent development, with paying attention to employee well-being and new way of working.
prevention, diagnosis, treatment and post-treatment care and management—to enable patients to improve their
This includes not only the areas directly involved in cutting-edge scientific research and digital technology, but also
quality of life.
initiatives targeting all functions and talent within the Company.
Transformative treatment through innovative therapeutic methods
Bringing new value to patients and their families suffering from diseases with no or limited treatment options that
Access to Health
Delivering medicines and medical services to those who need them through diverse approaches, including creating
cannot provide satisfactory outcome, as well as to society as a whole, through innovative therapeutic methods such
innovation and patient support programs for patients who cannot access necessary healthcare due to various
as cell and gene therapies that could significantly improve symptoms or potentially cure diseases with a single or a
circumstances such as geographical and socioeconomic factors. In addition, ensuring a stable and resilient supply of
few administrations by addressing the underlying causes of diseases.
products to patients by appropriately controlling the supply of raw materials, manufacturing, and distribution. This
includes measures against counterfeit medicines.
Value-based pricing
Ensuring that the price of products in the healthcare industry are set in a manner that fairly reflects the value they
bring to patients, their families, healthcare systems, and society.
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Strengthening Our Sustainability by Revising the Materiality Matrix
Strengthen business
activities to meet
expectations of society
Astellas manufactures products of excellence in quality at the global standard and continues to deliver safe products to
patients. It is our mission to ensure the stable delivery of our products to patients under any circumstances. While ensuring
the protection of human rights and safety of all those engaged in procurement, manufacturing, and distribution, ensuring
resilient supply chain management in the change of external environment throughout the supply chain. In addition, we will
continue to provide information to facilitate the safe and appropriate use of our products by patients. We will foster trust
from society by always thinking of patients and their families who are suffering from diseases, considering what healthcare
solutions are best for them and what Astellas’ products can contribute to them, and continuing our activities in an ethical
manner. We act with compliance and high ethical business practices in all aspects of our business as well as the provision of
product information. In addition, we contribute to the societal sustainability with evolving our governance to ensure fair
management decisions and operations.
Material issues to realize the above
Product quality assurance and product safety
Ensuring our products are manufactured with appropriate quality assurance standards.
Responsible supply chain management
Selecting suppliers in compliance with selection criteria, including sustainability perspectives, such as compliance
with laws, respecting human rights as well as diversity. Coaching suppliers that need improvements and sup-
porting their capacity building. Respecting the human rights of employees and business partners, including the
Safe and appropriate use of products
Enhancing the safe and appropriate use of our products by healthcare professionals and patients to ensure patient
safety and the efficacy and safety of our products. This includes responsible marketing and ethical advertising,
maintaining a functional and robust pharmacovigilance system.
Compliance and ethical business practices
Acting with integrity and making ethical decisions in all aspects in accordance with the spirit of the law and the
elimination of discrimination, the freedom of association and the protection of the rights to organize, and the
social norms that support it and going beyond compliance with applicable laws, regulations and industry codes.
exclusion of child labor and forced labor.
Promoting such behavior through our global compliance structure and the development, implementation, and
continuous enhancement of necessary policies and processes, and focusing our activities on Anti-bribery /
Anti-corruption compliance, avoiding conflicts of interest, seeking to pay the right amount of tax in the right
place at the right time, encouraging a “speak-up” culture, and demonstrating our commitment to integrity, ethics
and compliance.
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Corporate Data
The VALUE that Astellas Provides
Our Common Definition of VALUE Is the Foundation to Realize Our VISION
For Astellas to realize its VISION, we work with a “Common Definition of VALUE” (see graphic below)
to clearly communicate and share our aspirations with diverse stakeholders.
*
VALUE
OF PATIENTS
With “outcomes that matter to patients,” Astellas is committed beyond the
safety and efficacy of treatments. We seek to understand and optimize our
products, and their subsequent use, to maximize improvements in quality of
life (QOL) and to minimize the burdens they create.
For “costs to the healthcare system of delivering those outcomes,” we are
looking at the individual costs borne by the patient, the healthcare costs
borne by insurance companies and public institutions, as well as the indirect
costs and burdens imposed on the patient’s family and caregivers.
For example, if a drug proves effective in treating a disease that has
conventionally required surgery, the outcome for the patient will be significant.
It will not only lessen the physical burden on the patient, but also the mental
and lifestyle burdens generally experienced by patients.
These benefits are not limited to the patients alone. They will ripple out
across society, from the patient’s families and friends to medical institutions as
a whole. With lower hospitalizations and surgeries, these institutions can care
for a higher number of patients. Therefore, reducing the denominator in our
Common Definition of VALUE equation can affect a positive change across society.
We believe that by placing this concept at the core of our business and
adapting it to all divisions and regions, Astellas will be able to make a greater
contribution to healthcare.
Corporate Strategic Plan 2021 (CSP2021) is based on this “VALUE” equation,
with an overall aim to increase VALUE for patients and realize our VISION.
* Adapted from “What Is Value in HealthCare?” Porter, M.E. (2010).
New England Journal of Medicine
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Providing Value to Stakeholders
Value provided
• Improving people’s quality of life and
enhancing community healthcare by creating
innovative new medicines
• Improving technology level, development of
healthcare industry
• Recommendations for better healthcare policy
• Participating in economic and industry
associations and various external initiatives
Public
administration
Value provided
• Social contribution activities and donations
• Environmental conservation
• Job creation
• Increasing awareness and under-
standing of diseases and medical care
Examples of activities:
• Open forums (2 times/FY2021)
Target: General public
(including patients and their
families)
Local
community
Value provided
• Opportunities and places for self-development
and self-actualization
• Places, co-workers, and resources for solving
social issues and contributing to the health of
people around the world
• Job satisfaction
• Good working environment (work style reforms,
promotion of remote work, etc.)
• Compensation
Employees
Value provided
• Find new knowledge from research data to
create scientific innovation
• Applying cutting-edge research findings to
medical care
• Training researchers
Academia,
research
institutions
Patients and
their families
Healthcare
professionals
Value provided
• Fulfilling unmet medical needs by
creating innovative medicines and
medical solutions
• Providing information on safety
and efficacy
• Improving Access to Health (ATH)
• Ensuring a continuous stable
supply of investigational drugs and
commercialized products
• Support for patient organizations
• Reducing the burden on families
and the entire healthcare system
Dialogue results:
• Medical seminars for patients and their
families (4 times/FY2021)
Value provided
• Providing information on safety and efficacy
(including promotions)
• Ensuring a stable and resilient supply of
investigational drugs and commercialized
products
Dialogue results:
• Ask me anything (18 times/FY2021)
• Dialogue with CEO (30 times/FY2021)
• OHG Leadership Conversations
(3 times/FY2021)
Value provided
• Driving innovation and
creating new value through
collaborations with Astellas
and integration of capabilities
Business
partners
Shareholders
and investors
Value provided
• Sustainable enhancement
of enterprise value
• Stable shareholder dividends
• Timely and appropriate
information disclosure
• Engagement with investors
Dialogue results:
• IR meetings with securities analysts and
institutional investors (approx. 220 times/
FY2021, including 20 ESG meetings)
• Earnings calls and IR events (Corporate
Strategic Plan announcement,
R&D meeting, Sustainability meeting, etc.)
(10 times/FY2021)
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Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Progress of Corporate Strategic Plan
CONTENTS
Progress of Corporate Strategic Plan
23
Corporate Strategic Plan Review
Corporate Strategic Plan 2021
Interview with Chief Strategy Officer
Interview with Chief Financial Officer
Strategic Goal 1
Message from Chief Commercial Officer
Progress of Strategic Goal 1
Strategic Goal 2
Message from Chief Scientific Officer
Progress of Strategic Goal 2
Digital Transformation
Strategic Goal 3
Message from the Head of
the Rx+ Business Accelerator
Progress of Strategic Goal 3
Strategic Goal 4
Message from the Head of the
Sustainability Division
Progress of Strategic Goal 4
Organizational Health Goals
Message from the Head of Human Resources
People and Organization for Innovation
Initiatives for People and Organization
Organizational Health Goals
Engagement, Diversity, Equity and Inclusion
24
25
28
31
34
35
36
39
40
41
45
46
47
48
50
51
52
58
59
61
62
63
65
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Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Review of Corporate Strategic Plan
Corporate Strategic Plan 2015 (FY2015-FY2017)
Financial Guidance
ROE
15% or more
Maintain and improve this level after the
strategic plan period
15.1%
Average for 3 years, FY2015 – FY2017
Revenue
CAGR (%): Mid single-digit
Core operating
profit
CAGR that exceeds revenue
+1.4%*1
+7.5%*1
R&D investment
Higher than 17% of revenue
16-17% of revenue / improvement of cost structure
Core EPS
CAGR that exceeds CAGR of core
operating profit
DOE
6% or more
+13.2%*
Achieved EPS CAGR exceeding CAGR of core OP
along with enhancement of capital efficiency
5.7%
Result of FY2017
Corporate Strategic Plan 2018 (FY2018-FY2020)
Financial Guidance
Revenue
FY2017 level (¥1,300.3 billion)
R&D investment More than ¥200.0 billion
Core operating
Profit
Core Operating Profit margin 20%
Core EPS
Exceed FY2017 level (¥100.64)
¥1,249.5 billion
Not achieved
¥224.5 billion
Achieved
20.1%
Achieved
¥113.03
Achieved
Major Initiatives and Accomplishments
Strategic Goal 1
Maximizing Product VALUE and Operational Excellence
Sales of XTANDI and mirabegron steadily increased. XTANDI’s growth exceeded
original expectations
Continued launches of new products in Japan
6 post-PoC projects: Achieved important milestones as planned. Successful launches
of XOSPATA, PADCEV, EVRENZO and positive initial uptake
Operational Excellence: Prioritize sales promotion expenses and promote global procure-
ment efficiencies and travel cost reductions (approx. ¥50.0 billion*2 profit improvement)
*2 Cumulative total of FY2018-FY2020
Major Initiatives and Accomplishments
Renewed the VISION in 2015. Astellas declared
approach. Through the Corporate Strategic
a graduation from a business model that
Plan 2015-2017, we strengthened our global
specializes in specific disease areas. This
management system, expanded to various
became the origin of the shift to a Focus Area
modalities and biology, advanced late-stage
approach that constantly explores new busi-
development programs, and acquired key
ness opportunities from a multidimensional
assets.
*1 CAGR for 3 years starting from FY2014 results
Strategic Goal 2
Evolving How We Create VALUE: With the Focus Area Approach
Progressed clinical programs in the designated Primary Focus
Strengthened capabilities through collaborations and acquisitions to continuously
produce innovative projects
Enhanced utilization of innovative platforms among multiple Primary Focuses and
produced multiple promising projects
Strategic Goal 3
Developing Rx+ Programs
Progressed toward establishment of a foundation for Rx+ business
Achieved partnerships with various technologies from different fields
Successfully advanced multiple programs toward commercialization
Summary of CSP2018
We have established a common definition of
entry into gene therapy in addition to cell
VALUE that is the foundation to realize our
therapy. We have included Rx+ as one of our
VISION. As a strategy for creating VALUE, we
strategies in order to develop new healthcare
established a Focus Area approach and identi-
solutions. We have built the foundation to
fied Primary Focuses to invest in as a priority.
execute a Focus Area approach fully in the next
Through acquisitions, we have made a full-scale
CSP2021.
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Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Corporate Strategic Plan 2021
Corporate Strategic Plan (CSP) 2021 Overview
VISION
FY2021 - FY2025
CSP2021
Performance Goals
Aim to become a company with a Market Cap valued
at more than ¥7 trillion yen in FY2025 by achieving
1. Revenue: XTANDI and Strategic products* sales ≥ ¥1.2 trillion in FY2025
2. Pipeline Value: Focus Area projects expected sales ≥ ¥0.5 trillion in FY2030
3. Core Operating Profit Margin: ≥ 30% in FY2025
* XOSPATA, PADCEV, zolbetuximab, Evrenzo, fezolinetant, AT132.
Strategic Goals
1.
Enable patients to
achieve better
outcomes
2.
Translate innovative
science into proven
VALUE
3.
Advance the Rx+
business
4.
Deepen our
engagement in
sustainability
Astellas created Corporate Strategic Plan 2021 (“CSP2021”) as a 5-year plan for FY2021 to
FY2025 to pursue our VISION.
We characterize CSP2021 as follows:
• Evolved strategy
• Ambitious goals
• Transformative execution
• Same deep commitment to our VISION
In creating the CSP2021, we considered who we want to be in the long term. We refer to
this as the “Mature State” and, in short, our Mature State image is to be a “Cutting-edge,
VALUE-driven life sciences Innovator.”
One of the major differences between CSP2021 and CSP2018 is that it consists of 3 types of
goals that mutually reinforce each other as they are pursued.
First, we have strategic goals (“SGs”).
We have 4 Strategic Goals, and the first 3 goals focus on “what’s next” following our
efforts in CSP2018.
SG4 is newly introduced. We considered that it is needed to set the sustainability thinking
in the core of our business. We aim at solving social issues through our core business. Our
sustainability is the sustainability for both society and Astellas.
We have newly set Organizational Health Goals in CSP2021. We have adopted 3 goals.
We recognized that we need to transform our organization and create the best internal
environment to drive innovation and maximize our execution.
Organizational Health Goals
1. Unlock innovation
2. Talent & leadership thrives
3. Strengthen collaboration
• Fostering a corporate culture that
aims to achieve ambitious goals
• Significantly improving our
execution capabilities
Performance Goals are set to measure successful execution of CSP2021 and indicate our
ambitious goals in financial terms. We set goals from 3 aspects: revenue, pipeline value,
and core operating profit margin. By achieving these Performance Goals, we aim to
become a company with a market capitalization of more than ¥7 trillion in FY2025.
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Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Corporate Strategic Plan 2021
Progress of Strategic Goals
Goals
1. Enable patients to achieve better outcomes
2. Translate innovative science into proven VALUE
3. Advance the Rx+ business
4. Deepen our engagement in sustainability
Progress of Organizational Health Goals
Major Initiatives and Accomplishments
• Although the ambitious full-year forecast was not achieved, sales of XTANDI and strategic products increased 19% year on year
• Fezolinetant obtained top-line results from a SKYLIGHT 4 study, which is a Phase III long-term safety study. (Submitted fezolinetant NDA to the US FDA in June)
• Enfortumab vedotin received a CHMP positive opinion (subsequently, PADCEV was approved in the EU in April and launched). PADCEV was also approved and
launched in Japan Achieved additional approvals in the US
• Xtandi additional indication (mHSPC) approved in the EU
• EVRENZO approved and launched in the EU
• Reorganization of commercial functions in order to centralize and standardize functions globally and build stronger capabilities
• AT132 clinical study was put on clinical hold and the development plan was revised
• Achieved 9 candidate nomination decisions in research for clinical development
• 4 projects entered the clinical development phase with new modalities/technologies such as bispecific immune cell engager and protein degrader
• There were judgments in 7 projects among the ones expected for PoC judgement within the CSP2021 period. As a result, no projects achieved PoC in FY2021
• Reformed the research organization to be agile and accelerate innovation
• First program commercialization (My Holter II, ECG analysis service using AI)
• Based on the good results obtained in the Phase II study of ASP5354, preparations are being made for conducting the Phase III study
P.34
P.39
P.46
• Updated our materiality matrix and reidentified 19 key issues including 9 material issues (Materiality)
• Developed and disclosed Access to Medicines strategy, and selected 4 programs for the health system strengthening
• Scenario analysis was conducted for disclosure based on TCFD recommendations. In 2021, a qualitative analysis was conducted and published
• Strengthened in advocacy of our efforts on sustainability (e.g., conducted sustainability meeting for the investor community, named in the FTSE4Good Index
P.50
Series for 11 consecutive years)
Goals
Major Initiatives and Accomplishments
1. Unlock innovation
2. Talent & leadership thrives
3. Strengthen collaboration
• Promoted deep understanding of CSP2021 among all employees, with increased direct communication by Top Management
• Redesigned divisional objective-setting with shared and ambitious objectives
• Astellas Leadership Expectations were formulated to substantially transform our corporate culture, and training for all leaders (about 3,000 people) was
completed
P.58
26
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Corporate Strategic Plan 2021
Relationship to Material Issues
1
2
3
4
5
6
7
8
9
Access to Health
Fulfilling unmet
medical needs by
creating novel
healthcare
solutions
Transformative
treatment through
innovative
therapeutic
methods
Value-based
pricing
Product quality
assurance and
product safety
Safe and
appropriate use
of products
Compliance and
ethical business
practices
Responsible
supply chain
management
Talent and
organizational
culture for realizing
innovation
Astellas will evolve sustainability for society and Astellas by addressing the key social issues and materiality
Strategic Goals
1. Enable patients to achieve
better outcomes
2. Translate innovative science
into proven VALUE
3. Advance the Rx+ business
4. Deepen our engagement in
sustainability
Organizational Health Goals
1. Unlock innovation
2. Talent & leadership thrives
3. Strengthen collaboration
27
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Interview with Chief Strategy Officer
Naoki Okamura
Representative Director,
Executive Vice President
Chief Strategy Officer (CStO)
Continuing to generate innovation is an abiding
theme for us. To that end, we will transform Astellas
into an optimal organization with optimal work styles
as we steadily execute Corporate Strategic Plan 2021.
Q.
A.
Tell us about the positioning of Corporate Strategic Plan 2021
and the key points involved in achieving its goals.
Corporate Strategic Plan 2021 is a further evolution of Corporate
Strategic Plan 2018. To realize the goals of the new plan, it is essential
that employees themselves drive transformation proactively.
Corporate Strategic Plan 2021 (“CSP2021”) is a
like when our management approach and our
roadmap for realizing Astellas’ VISION “to be at
business direction are successfully matched. In
the forefront of healthcare change to turn inno-
other words, CSP2021 clearly lays out what to do,
vative science into VALUE* for patients.” The 4
how to do it, and what we will achieve in the end.
Strategic Goals set forth in the plan are a further
To achieve the goals, I think it is vital for all
evolution of the 3 Strategic Goals of Corporate
Astellas employees to drive transformation by
Strategic Plan 2018 (“CSP2018”), with the addition
themselves proactively, with a deep under-
of sustainability- related initiatives. The business
standing of the concepts and philosophy of
areas the Company is focusing on remain
CSP2021 and broader perspectives between
unchanged. Looking back on CSP2018, however,
the Company’s position and each employee’s
although the goals were clear, we realized there
own mission. So, I believed that the penetration
were factors which are hindering us from effec-
of the concepts of CSP2021 was our most
tive execution. In CSP2021, therefore, we set
critical task, we focused on dialogue with
Organizational Health Goals as means of achiev-
employees in FY2021 as the first year of the
ing the Strategic Goals, and set Performance
CSP2021. We fully delineated the newly estab-
Goals describing what the Company will look
lished Organizational Health Goals and
28
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
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Interview with Chief Strategy Officer
Performance Goals in particular, and held a
sessions had about 7,000 employees (including
Although there are several things not
sense is that each Strategic Goal made solid
total of 18 “Ask Me Anything” sessions— internal
those attending multiple sessions), and 730
achieved when we see in detail, overall our
progress in the first year of CSP2021.
meetings held online in which employees were
questions were answered.
able to interact with me directly. Altogether, the
*1 Proof of concept refers to confirming efficacy and other aspects of a product in clinical trials to support moving into late- stage
development.
*2 Investigational device exemption is an application made to the FDA to allow a device to be used in a clinical study in order to
* Astellas defines VALUE as “Outcomes that matter to patients” divided by “Cost to the healthcare system of delivering those out-
comes.” See P.21 for more information on our VALUE.
collect safety and efficacy data.
*3 For details, please refer to P.17.
Q.
A.
Tell us about the progress of the Strategic Goals set out in CSP2021.
Q. What kind of initiatives can we expect in FY2022?
In FY2021 as the first year of the CSP2021, each strategy has made
solid progress.
A.
We will steadily achieve development and regulatory milestones of
strategic products. In particular, once we obtain approval of
fezolinetant, we will finally be able to launch it in the US.
I would like to look back at the Strategic Goals
and commercialization of the My Holter II ECG
individually. In terms of Strategic Goal 1 “Enable
analysis service. In the area of bioelectronics,
FY2022 is a key year for achieving the
women suffering from VMS in the US received
patients to achieve better outcomes,” sales of
iota Biosciences, Inc., which we acquired in
Performance Goals of FY2025. We plan to file in
hormone replacement therapy (HRT). However,
strategic products grew, offsetting sales declines
2020, moved forward with development of tiny
the US for XTANDI for non- metastatic castration-
since HRT was identified as posing a risk for
by the termination of distribution agreements
wireless and implantable medical devices as
sensitive prostate cancer. We also plan to file in
other diseases and there were no other alterna-
and product transfers for mature products.
small as a few millimeters or less. As this is
the US for enfortumab vedotin (PADCEV) as a
tives, VMS has been left virtually untreated for
Although performance in the Q4 was not good
promising for a wide range of applications, we
first- line treatment for metastatic urothelial
the past 2 decades. Fezolinetant meets this
enough, I think our current growth strategies
have high expectations for this technology as a
cancer. We also expect to obtain the topline
unmet medical need, using a completely differ-
performed well throughout the year.
next- generation business. Several projects are
results of several pivotal trials. By steadily achiev-
ent mechanism of action from HRT. Given the
Regarding Strategic Goal 2 “Translate innova-
tive science into proven VALUE,” we were disap-
pointed not achieving any PoC*1 in FY2021.
progressing ahead of schedule and we are
preparing to apply for an IDE*2 to move forward
ing these milestones, we will develop the foun-
situation in 2000, we assume that the market
dation for sustainable growth and move toward
potential for the drug is unchanged, at 12 million
to the clinical stage.
a medium- to long-term profit growth trend.
people. We forecast 500 billion yen peak sales at
However, we did see following success results: 9
Finally, in terms of Strategic Goal 4 “Deepen
Another important upcoming topic is the
most, and expect fezolinetant to become a core
new therapeutic drug candidates started prepa-
rations for clinical development, and 4 projects
our engagement in sustainability,” we revised
the Materiality Matrix*3. It was a great accom-
application for approval of fezolinetant in the US
product after XTANDI. We will seek to garner
in June 2022. This drug is for the treatment of
awareness of the drug among both physicians
entered into the clinical stage.
plishment to redefine the former 31 key issues
vasomotor symptoms (VMS) associated with
and patients, aiming to expand sales quickly.
We saw solid progress with Strategic Goal 3
into 19 issues, while clarifying that 9 of the 19
menopause. Until around 2000, 12 million
“Advance the Rx+ business,” including starting
key issues have priority in terms of our sustain-
pilot marketing of the Fit- eNce Home service
ability initiatives.
29
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Interview with Chief Strategy Officer
Q.
Going forward, what should be the central focus for Astellas
and what should be transformed?
A.
Continuing to generate innovation is an abiding theme for Astellas.
To that end, we will transform the organization, ways of working,
and our talents.
risks of new actions and responses before we
report to me, 10 people are located outside
take those new actions. That kind of approach
Japan. Nearly all functions of the corporate
is simply not viable at the frontlines of current
organization are globalized. We are confident
R&D. To survive, it is critical for highly special-
that we can maintain close communication
ized staff to step up the pace of repeated trial-
with one another without going to the Tokyo
and- error research while taking risks
headquarters—it is how we are already operat-
appropriately. However, the critical thing is not
ing day to day. We will continue working to
merely the shape of the research organiza-
create a more open, more flat organization.
The pharmaceutical industry underwent a major
innovation. Our task is to take on the challenge
tion—the idea is to raise the risk tolerance of
We are also looking to attract core talent
change at the turn of the 21st century. In the
of doing something that has never been done
the Company as a whole.
from outside the Company. Not only in R&D but
past, product development by improving exist-
before. Fear of failure does not lead to success.
For the work styles of employees outside of
also in corporate divisions, professionals in their
ing products generated profits well. Now, how-
In FY2021, we transformed our research
R&D, we are moving away from our former way
respective fields have come onboard at Astellas
ever, if a pharmaceutical company cannot
organization, getting rid of the former top-
of doing things as well. For instance, online
at the level of executive leaders. I am delighted
provide truly superior products to the market, it
down and functional organizations and transi-
meetings are now the mainstream, joining
for the new vitality and creativity that such
loses its raison d’ être. Consequently, by turning
tioning to an agile organization that enables
from all over the world. Of the 14 leaders who
personnel are bringing to Astellas.
innovation into VALUE, we seek to create prod-
rapid decision- making and autonomous activi-
ucts that only Astellas can deliver.
ties. In the processes of the former organization,
“Intelligent risk-taking” is needed for
we spent a lot of time and effort analyzing the
Q. As CStO, do you have a message for stakeholders?
A. We will work as One Astellas to achieve sustainable growth.
I put a secondary title to CSP2021 as the “5 years
demonstrate leadership, and enjoy working to
for us to prove that Astellas will continue to grow
reach further heights. I ask our investors, cus-
even after the XTANDI patent expires.” I believe
tomers, and business partners to look forward
other strategic products can fill the gap of the
to VALUE that Astellas is going to create.
expiration of the XTANDI patent. However, fur-
ther growth will depend on the success of the
pipeline from Primary Focuses and the Rx+
business. The key to success is achieving the
Organizational Health Goals. Under the banner
of “One Astellas,” I would like all employees to
have the courage to take risks appropriately,
30
Naoki Okamura
Representative Director,
Executive Vice President
Chief Strategy Officer (CStO)
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
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Interview with Chief Financial Officer
We will target profit growth by
balancing growth investments and
cost reductions and increase our
valuation through emphasizing
accountability and sustainability.
Minoru Kikuoka
Senmu Tantou-Yakuin
Chief Financial Officer (CFO)
Q. What are your ambitions in your new role as CFO?
A.
I will use my experience and knowledge to contribute to
Astellas, which is accelerating its globalization,
in order to increase global competitiveness.
and undertake a lot of technology out-licensing.
employees go beyond the barriers of language,
In recent years, to drive open innovation and
culture, and distance further and push forward
gain new capabilities, we have not only been
to the same goal.
pursuing in-licensing and alliances, but also
I would like to contribute to Astellas, which
actively acquiring companies outside Japan.
is accelerating its globalization, by leveraging
These companies continue to operate within
my experience as a CEO, and as a CFO during
the Astellas Group as independent divisions.
the manufacturing of electronics-related mate-
However, in the future, we recognize the need
rials and parts, as well as my knowledge of the
for “true” globalization, in which all Astellas
pharmaceutical industry.
Q. What are your thoughts on growth investment and cost reduction?
A.
Cost reduction wouldn’t always come first. It’s important to figure
out investments which are crucial for Astellas to grow.
In the electronics industry, in which I have
One of the Performance Goals of the
experience, the business model is that products
Corporate Strategic Plan 2021 (CSP2021) is to
have short product lifespans, so unless the
achieve more than 30% core operating profit
investment is quickly recouped, the product will
margin in FY2025. Our explanation to achieve
be replaced by the next new product. Therefore,
this target is to keep SG&A expenses flat in
while investing in development, the point is to
terms of the absolute amount. In taking on the
rapidly improve the profit margin by thoroughly
challenge of achieving this goal, I would not
reducing costs during the mass production
approach it with a mindset of “defending the
phase. In the pharmaceutical industry, however,
absolute amount of SG&A expenses at all cost.”
once a product is launched and is covered by
This is because there are a variety of things that
insurance reimbursement, a certain amount of
change on a daily basis in the course of expand-
profit is guaranteed for as long as the patents
ing our strategic products, and if we only focus
I am Minoru Kikuoka and I joined Astellas as CFO
marily by in-house medical representatives (MRs).
protect said product.. So the important question
on cost reduction, we may miss opportunities.
in March 2022. Since around the 2000s, Astellas
I believe it promoted a unique globalization
is how to deal with the huge investment in
Increases and decreases in SG&A expenses
has focused on commercialization by themselves
among Japanese pharmaceutical companies,
research, development and commercialization
are the result of optimal investment that priori-
for outside Japan, building an infrastructure pri-
which at that time had many sales alliances
strategy after the product launch.
tizes growth. In reality, sales revenue may be
31
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
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Strengthening Governance
Corporate Data
Interview with Chief Financial Officer
large and SG&A expenses may be large, or
requires a marketing strategy focusing on fulfill-
“monozukuri” (manufacturing) approach for
concept of “Dansharism”, which promotes elimi-
conversely, sales revenue may be small and
ing patients’ needs. Although it is a product with
which Japan is renowned around the world.
nating work with low priorities and leads to
SG&A expenses may be small.
great profit potential, I believe it needs manage-
Although Astellas has a different business
making necessary investments, will be the
As CFO, it is my responsibility to find the
ment leadership because various activities after
model, I believe that we can achieve significant
foundation for Astellas’ global innovation and
most efficient balance for Astellas’ sustainable
obtaining marketing approval are important in
improvements in business efficiency by sharing
will lead to a significant improvement on the
growth and maximization of corporate value.
order to maximize its VALUE. For this reason, I
successful Danshari examples globally. The
SG&A ratio described in CSP2021.
For example, fezolinetant, for which we
believe that another role of the CFO is to disclose
submitted an NDA to the US FDA in June 2022,
and communicate detailed information and
is not only an innovative new drug, but also
further enhance the accountability of Astellas.
Q. What is so-called “Dansharism,” which started from FY2022?
A.
Dansharism is a new initiative where each employee is encouraged
to develop financial discipline and cost ownership. Furthermore, it
dramatically improves labor productivity and brings innovation.
The first initiative I introduced right after I was
profits under improved efficiency if the existing
appointed to the CFO was “Dansharism” and I
corporate culture or environment remain
am currently promoting all Astellas employees
unchanged. In order to prevent this situation, I
for better understanding. Dansharism does not
encourage all employees to look back at their
simply mean cost reduction but aims to dramat-
individual work, identify every opportunity, and
ically improve labor productivity by fostering
become “brave” to release things that are in your
financial discipline and cost ownership in each
way (such as creating periodical reports uncon-
employee, and a major shift in the mindset of
sciously, or attending a marathon meeting).
day-to-day operations.
I believe the time and mental white space
Many companies tend to have routine work
created in this way will become the source of
lasting for many years or labor and costs that do
innovation for future Astellas employees.
not directly link to the revenue. However, under
Many Japanese companies have thoroughly
* DX: Digital transformation
Step of Dansharism
1. Thoroughly reevaluate our
work and activities without
exception
2. Define what work to halt
or terminate
3. Actually halting or
terminating that work
Target:
Specification:
Execution:
All work, including accepted
practices continuing on from the
past, outdated processes, and
routine work
Classification:
Categorize work with a “Must have”
or “Nice to have” perspective
Specify work that brings “less”
ROI or are “less” priority
(Example)
Existing outdated processes, reports
of similar content, reports of
excessive quality, review of meeting
attendees, etc.
Be “courageous” and halt work
that was specified in order of less
importance and eventually secure
a white space for employees
Consequently, invest resources in
new things while reducing costs
Building an environment that enables the creation of innovation in a sustainable
manner through thorough efficiency improvements
Q. What are your thoughts on capital allocation and financing?
A.
Our top priority is investment for business growth. We will also
consider share buybacks while securing liquidity on hand.
these circumstances, innovation would not
eliminated such waste during the process of
In our capital allocation policy at Astellas, our
the profit/cash flow plan and actual perfor-
occur. In addition, there are cases where, for
improving profits and quality in mass produc-
top priority is investment for business growth.
mance throughout the CSP2021 period. When
example, DX* investment cannot create additional
tion at their factories. This has given rise to the
We plan to raise the dividend level aligned with
excess cash is available, we will execute share
32
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Interview with Chief Financial Officer
buybacks flexibly. Astellas will consider these
a large-scale acquisition that could affect the
processes on the basis of securing liquidity on
future of the Company.
hand. If cash and deposits constantly exceed
The financial status of Astellas is extremely
250-350 billion yen, we will consider executing
healthy. To enhance our stock price valuation,
share buyback.
however, we need to deepen our discussion on
As CFO, I believe that we should not limit our
the optimal capital structure such as the debt-
Q.
A.
Lastly, what are your thoughts on valuation?
A. In addition to profit growth, we emphasize accountability and
sustainability, and aim to increase corporate value.
growth by too much sticking to maintaining a
to-equity ratio and ROE. In particular, in prepara-
Astellas has earned a certain degree of recog-
shareholders and investors and gaining a
conservative balance sheet. My responsibility is
tion for the risk of an era of high interest rates,
nition from the investment community for its
sense of security and understanding from
to support the acquisitions and alliances that
we will also review the ratio of short-term and
management strategy. But we need to make
other stakeholders through the sufficient level
are necessary for Astellas and to arrange the
long-term borrowings.
further efforts to increase corporate value
of disclosure.
financing, including capital policy in the case of
going forward. One of our goals is to obtain a
higher evaluation in terms of profit multiples
on valuation by executing CSP2021, but as CFO
I would like to manage the Company with
sufficient attention to the stability of the exter-
nal evaluation.
In order to improve corporate value, not
only profit growth but also accountability and
sustainability are important components. As I
mentioned earlier, our policy is to increase
corporate value by earning the trust of our
Minoru Kikuoka
Senmu Tantou-Yakuin
Chief Financial Officer (CFO)
33
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
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Strengthening Governance
Corporate Data
Strategic Goal 1
Enable patients to achieve better outcomes
Astellas is committed to maximize patient access to our
products and to partner effectively with healthcare
stakeholders to secure the realization of VALUE. To
achieve this, we strive to accelerate submission of New
Drug Applications (NDAs), reducing the time to achieve
broad geographic coverage, implementing sophisticat-
ed launch plans and prioritizing our efforts across the
portfolio towards where the VALUE opportunity is
greatest. It is through pursuing these activities in asso-
ciation with this Strategic Goal that Astellas will maxi-
mize the value of XTANDI and Strategic products that
drive medium- to long-term growth. Strategic products
are fezolinetant, PADCEV, XOSPATA, zolbetuximab,
EVRENZO and AT132.
Relationship to Material Issues
• Access to Health
• Fulfilling unmet medical needs by creating novel
healthcare solutions
• Transformative treatment through innovative
therapeutic methods
• Value-based pricing
• Product quality assurance and product safety
• Safe and appropriate use of products
34
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Strategic Goal 1 Enable patients to achieve better outcomes
Message from Chief Commercial Officer
We are striving to globalize
our organization with a view
to continuing to deliver better
outcomes to patients.
Yukio Matsui
Senmu Tantou-Yakuin
Chief Commercial Officer (CCO)
One of my major achievements as CCO has been the focus on the
globalization of the commercial organization.
It enabled us to establish a platform that can efficiently develop
and deliver high-value-added products globally.
environment such as the COVID-19 pandemic, we changed the organizational structure. It is
promoting digital transformation and deploying online sales representatives to approach new
customers as well as existing customers. At the same time, by optimizing the resource allocation
to align with our business strategy we have been able to focus our resources on products that
are highly profitable. As a result, we achieved double-digit growth for our strategic products.
We continue striving to deliver better outcomes to
patients while strengthening and improving
our human resources and corporate culture.
In FY2022, to realize the Strategic Goals set in CSP2021, maximizing VALUE for patients remains a
key priority. My responsibility is to define and execute what to change and optimize in order to
maximize VALUE for patients. This allows appropriate collaboration with Medical Affairs and
other functions, rather than focusing solely on optimizing the commercial organization.
Furthermore, we don’t rely on traditional face-to-face communication. We aim to pursue an
omnichannel approach combining digital and non-digital communication depending on
customer preferences. As we believe these initiatives will lead to maximizing the VALUE offered
through our products, we are focusing not only on existing products such as XTANDI, but also
As CCO, since FY2021 I have devoted my attention to meeting the goals set in our Corporate
preparing for the launch of fezolinetant, and for the additional indication of PADCEV (first-line
Strategic Plan 2021 (CSP2021). In that respect, I am proud of our efforts toward the globalization
treatment for metastatic urothelial cancer). We expect these products to become potential
of our commercial organization. We have strategically enhanced and consolidated product
growth drivers. In CSP2021 we are targeting a core operating profit margin of 30% or greater in
marketing functions. Also, we have been making bold changes to our organization and division
FY2025. To achieve the goal, it is critical to enhance our organizational capabilities and create an
of roles in such a manner. As a result, we enabled consistent operations worldwide. Specifically,
efficient structure that generates higher returns on investment.
we have undertaken workforce optimization, and transformed our organization. We changed it
The key factors supporting these initiatives are talent, mindset and corporate and organiza-
from a regionally segmented commercial organization into one that facilitates brand marketing
tional culture. We will continue to strengthen and enhance all these factors through working
and sales support globally. Furthermore, in order to respond to changes in the external
toward Organizational Health Goals that are important to achieve Strategic Goals in CSP2021.
35
Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Strategic Goal 1 Enable patients to achieve better outcomes
Progress of Strategic Goal 1
Potential peak sales of XTANDI and Strategic products
XTANDI (enzalutamide)
In CSP2021, we disclosed potential
peak sales of XTANDI and Strategic
products and we reviewed them in
April 2022. We forecast robust
growth for XTANDI and Strategic
products. In one of our Performance
Goals, we target more than 1.2 trillion
yen in sales in total from these
products in FY2025.
Product*1
Potential Peak Sales
(Global, billions of yen)
XTANDI (enzalutamide)
fezolinetant
600 – 700
300 – 500
PADCEV (enfortumab vedotin)*2
300 – 400
XOSPATA (gilteritinib)
zolbetuximab
EVRENZO (roxadustat)*3
100 – 200
100 – 200
50 - 100
*1 Only indications undergoing pivotal studies are included for projection. (as of April 2022)
*2 Sales for Americas are calculated based on the sales booked by Seagen.
*3 Astellas territories only; Japan, Europe, the Commonwealth of Independent States, the Middle East, South Africa, etc.
Key events anticipated during CSP2021 (as of July 2022)
For XTANDI, PADCEV and XOSPATA,
we plan to expand indications to
include cancer patients at earlier
stages and seek to maximize product
value. For fezolinetant, we filed for
regulatory approval in the US in
June 2022 and anticipate launching
in late FY2022. For zolbetuximab, we
aim to file for regulatory approval
in FY2023.
XTANDI sales totaled 534.3 billion yen in FY2021, up 17% year
on year. In Europe, an additional indication of M1 CSPC (meta-
static castration-sensitive prostate cancer) was obtained in April
2021, contributing to sales growth. During the CSP2021 period,
we expect to expand indication for M1 CSPC in Mainland China
and broaden indication for earlier stage M0 CSPC (non-metastatic
castration-sensitive prostate cancer) in the US. Sales have been
steadily increasing, raising the likelihood of achieving the
potential peak sales of 600–700 billion yen.
Sales Forecast (Image)
M0 CSPC
Peak
600 – 700
billion yen
M0 CSPC
M1 CSPC
M0 CRPC
M1 CRPC
Product*4
XTANDI
(enzalutamide)
XOSPATA
(gilteritinib)
PADCEV
(enfortumab vedotin)
zolbetuximab
fezolinetant
AT132
(resamirigene bilparvovec)
FY2021
FY2022
FY2023
FY2024
FY2025 or later
Target Filing Timing
M0 CSPC
AML, post-HSCT
maintenance
AML, newly diagnosed
and HIC-eligible
mUC, previously
untreated (AA in US)
based on
EV-103 study cohort data
mUC, previously
untreated (1L)
MIBC
FY21
FY25
M1: Metastatic, CRPC: Castration-resistant prostate cancer
FY30
As of CSP2021 announcement (May 2021)
Gastric and GEJ
adenocarcinoma
Moderate to severe VMS
associated w/ menopause
Glossary of Abbreviations
XLMTM
M0: Non-metastatic CSPC: Castration-sensitive prostate cancer AML: Acute myeloid leukemia
HSCT: Hematopoietic stem cell transplantation HIC: High-intensity chemotherapy mUC: Metastatic urothelial cancer
AA: Accelerated Approval 1L: First line MIBC: Muscle-invasive bladder cancer
GEJ: Gastroesophageal junction VMS: Vasomotor symptoms XLMTM: X-linked myotubular myopathy
*4 Only indications undergoing pivotal studies are included (as of Apr 2022). Subject to internal assessment, decision and regulatory
consultation, as appropriate. Filing (submission) timing in the first country/region within US, EU, JP.
36
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Strategic Goal 1 Enable patients to achieve better outcomes
Progress of Strategic Goal 1
PADCEV (enfortumab vedotin)
XOSPATA (gilteritinib)
PADCEV sales totaled 21.7 billion yen in FY2021, up 70% year on
year. In the US., additional indication was obtained in July 2021,
and market penetration exceeded expectations in Japan and
Europe where it was launched from November 2021. As for the
development status of the first line mUC (metastatic urothelial
cancer), which is expected to be the largest growth driver,
positive topline results were obtained from one of the clinical
trials, EV-103 study Cohort K in July 2022. Progress is on track to
achieve the potential peak sales of 300–400 billion yen.
Sales Forecast (Image)
MIBC
Peak
300 – 400
billion yen
MIBC
1L mUC
2L+ mUC
1L mUC
FY21
2L+: Second line and later
FY25
FY30
XOSPATA sales totaled 34.1 billion yen in FY2021, up 43% year on year.
Established the position of market leader in the US and Japan. It was
launched in Mainland China in April 2021 and launches in other
countries are planned. During the CSP2021 period, we expect to
expand indications for earlier-stage patients, and progress is on track
to achieve the potential peak sales of 100–200 billion yen.
Sales Forecast (Image)
Newly diagnosed
and HIC-eligible
Post-HSCT
maintenance
Peak
100 – 200
billion yen
Newly diagnosed (HIC eligible)
Post-HSCT maintenance
R/R
R/R: Relapsed or refractory
FY21
FY25
FY30
As of CSP2021 announcement (May 2021)
EVRENZO (roxadustat)
EVRENZO sales totaled 2.6 billion yen in FY2021, up 132% year on year. In
Japan, progress has been below expectations due to intense competi-
tion. In Europe, where it was launched in September 2021, differentia-
tion from existing standard of care has not progressed as expected. On
the other hand, we expect reimbursement to start in European countries
in the second half of FY2022 and expect the sales to increase thereafter.
As of CSP2021 announcement (May 2021)
Sales Forecast (Image)
Peak
50 – 100
billion yen
Anemia associated
with CKD
CKD: Chronic kidney disease
FY21
FY25
FY30
As of CSP2021 announcement (May 2021)
37
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Strategic Goal 1 Enable patients to achieve better outcomes
Progress of Strategic Goal 1
zolbetuximab
Zolbetuximab is a first-in-class antibody targeting Claudin 18.2. Topline results from 2
Phase Ⅲ studies in gastric and gastroesophageal junction adenocarcinoma are
expected in the second half of FY2022. Based on these studies, we aim to file for
regulatory approval in FY2023. Our goal is to establish zolbetuximab as the first-
choice treatment for eligible patients, and we are projecting potential peak sales of
100–200 billion yen.
Sales Forecast (Image)
Peak
100 – 200
billion yen
Gastric and GEJ
adenocarcinoma
FY21
FY25
FY30
As of CSP2021 announcement (May 2021)
fezolinetant
Fezolinetant is an investigational nonhormonal compound being developed for
the treatment of moderate to severe vasomotor symptoms ( VMS) associated with
menopause. We have obtained positive results from 3 Phase Ⅲ studies. Fezolinetant has
progressively achieved development milestones and we are preparing for the
launch, with the goal of achieving potential peak sales of 300–500 billion yen.
Sales Forecast (Image)
Peak
300 – 500
billion yen
Moderate to severe VMS with
associated menopause
FY21
FY25
FY30
As of CSP2021 announcement (May 2021)
Development of fezolinetant
Vasomotor symptoms ( VMS), characterized by hot flashes (also called hot flushes) and/or night sweats, are
common symptoms of menopause. In the US, about 60% to 80% of women experience these symptoms during
or after the menopausal transition and, worldwide, more than half of women 40 to 64 years of age experience
VMS. VMS can have a disruptive impact on women’s daily activities and overall quality of life.
In the past, hormone replacement therapy (HRT ) was widely used for the treatment of menopausal
symptoms. As of 2000, approximately 12 million patients were prescribed it annually in the US alone. However,
in 2001, a study result was reported that showed an association between chronic HRT use and increased risk of
breast cancer and cardiovascular disease. After that, the HRT use has sharply decreased, and the amount of its
prescriptions is about one-thirtieth of that in 2000. To date, an effective alternative to HRT has not been
developed, and VMS treatment options are considered to be limited.
Fezolinetant, a neurokinin-3 receptor antagonist, works by blocking neurokinin B binding on the
kisspeptin/neurokinin/dynorphin (KNDy) neuron to moderate neuronal activity in the thermoregulatory center
of the brain (the hypothalamus), and then reduces the frequency and severity of moderate to severe VMS
associated with menopause through a mechanism different from HRT.
In June 2022, New Drug Application (NDA) was submitted to the US Food and Drug Administration (FDA),
supported by the results of 3 Phase III clinical trials that collectively enrolled over 2,800 women with VMS at
over 180 sites within the US, Canada and Europe and characterized the efficacy and safety of fezolinetant up to
52 weeks. The NDA was accepted by FDA in August, and the PDUFA target action date is February 22, 2023,
following the use of a priority review voucher. If approved, fezolinetant would be the first-in-class nonhormon-
al treatment for moderate to severe vasomotor symptoms associated with menopause.
US Annual Premarin Family-treated Patients*1
# of Premarin Family TRx Patients (000s)
14,000
Approx.
12M Women TRx HRT
12,000
10,000
8,000
6,000
4,000
2,000
0
Market
potential
Approx.
0.4M
2000
2004
2008
2012
2016
2020
Hypothalamus
KNDy neuron
NKB
Estrogen
fezolinetant
NK3R antago-
nism blocks NKB
and moderates
neuronal activity
Medium preoptic
nucleus
NKB
NK3R
ERα
NK3R
NKB
Estrogen
Thermoregulatory center
Periphery
Treatment of VMS
VMS Frequency
and Severity
*1 IQVIA NPA - Premarin Family (Premarin,
Prempro, Premphase)
*2 The thermoregulatory center in the hypothalamus of the brain is innervated by KNDy neurons which are inhibited
by
estrogen and stimulated
by NKB via NK3R in a delicate balance.
*3 Absence of estrogen negative feedback leads to hypertrophy of the KNDy neuron and alters the activity on the
thermoregulatory center.
*4 Fezolinetant is a selective NK3R antagonist that blocks NKB binding on the KNDy neuron to moderate neuronal activity in
the thermoregulatory center, helping to restore thermoregulatory balance.
*5 Figure adapted from Depypere H, et al. Expert Opin Investig Drugs. 2021; 30: 681-694.
KNDy: Kisspeptin/Neurokinin/Dynorphin; NKB: neurokinin B; NK3R: neurokinin-3 receptor; ERα: estrogen receptor alpha
38
Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Strategic Goal 2
Translate innovative science into proven VALUE
Astellas enhances its pipeline value by giving priority to
the investment of management resources into its Primary
Focuses. Through acceleration of the demonstration of
VALUE, the growth of Primary Focuses, and the effective
exploration of cutting-edge biopharmaceutical innova-
tion, we aim to take our efforts of CSP2018 to the next
level. Astellas is working on researching and developing
life-changing therapies through priority investment in
Primary Focuses selected based on the Focus Area
Approach. We believe that the innovative treatments
we are developing will enable a paradigm shift from
symptomatic to curative therapies*1, bringing great
hope to patients desperate for new therapies that will
treat previously untreatable diseases.
9 research programs with various new modalities have
been progressed to new drug candidates*2 in FY2021.
We will continue our best effort to develop innovative
medicines from our Focus Area Approach in FY2022.
*1 Curative therapies: A therapeutic approach that addresses the root cause of a disease and
significantly improves the condition with one or only a few treatments.
*2 New drug candidate: therapeutic entities that entered the preparation phase toward
Investigational New Drug application/clinical development.
Relationship to Material Issues
• Access to Health
• Fulfilling unmet medical needs by creating novel
healthcare solutions
• Transformative treatment through innovative therapeutic
methods
• Value-based pricing
39
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Strategic Goal 2 Translate innovative science into proven VALUE
Message from Chief Scientific Officer
Our progress in Focus Area
approach further expands
our pipeline, with a boost
from research reorganization.
Yoshitsugu Shitaka
Senmu Tantou-Yakuin
Chief Scientific Officer (CScO)
We are ready to create new drugs with a greater therapeutic impact, by
incorporating evolutions in modalities and focusing on underlying
causes of diseases in the most effective manner.
As CScO, I would like to take this opportunity to reiterate Astellas’ reasons for adopting the Focus Area
approach. In recent years, technological advancements provide us with more opportunities to incorporate
them into our strategy, as various modalities are becoming realistic, including cells, genes, and mRNAs in
addition to conventional small molecules and antibodies. Different combinations of biology and modality/
technology can greatly alter the target patient population and expected drug efficacy even for the same
disease. We have opted for a Focus Area approach in which we consider ideas from a multifaceted
perspective that adds modality/technology to the conventional disease and biology, always with an eye on
the combination’s scientific validity. We believe that by selecting the most rational combination to address
the cause of disease, we will be able to create new drugs with greater therapeutic impact.
In my first fiscal year we focused on steady progress in the pipeline and
building a foundation for sustainable growth.
FY2021 was the first year of our Corporate Strategic Plan 2021 (CSP2021), and my first year as CScO.
Our top priority has been to expand the pipeline. We were able to advance 4 programs to the clinical trial
stage, including ASP3082*1 and ASP2138*2, which are expected to lead related products. We also created 9
new drug candidates and made progress in expanding our early-stage drug discovery program.
ASP3082 is a novel compound employing a new drug discovery technology called Targeted Protein
Degradation (TPD) *3. By reviewing the project process to the initiation of clinical trials from scratch and
taking intelligent risks to shorten the period, we were the first in the world to enter the clinical stage for the
40
target. The TPD drug discovery platform created in the process of generating ASP3082 already support the
discovery of follow-on compounds. We hope to launch multiple products as a product family using TPD
before long. Another noteworthy achievement is the creation of new drug candidates from a wide range of
cutting-edge modalities, including cell and gene therapies in addition to small molecules. Cell and gene
therapies are no longer special modalities for us, and we are completing a system to generate a constant
flow of development candidates. In addition, in FY2021 the strengthening of DX*4 began to bear fruit as the
utilization of robotics and AI contributed to a reduction in the compound optimization period*5, and our
proactive investment in DX began to contribute to the expansion of our pipeline.
We undertook Research reorganization with the strong belief that this is key to enhancing our Research
productivity. Through this reorganization, we transformed all groups involved in the candidate discovery into
agile organizations*6 like bio-ventures. We are confident that this Research organizational structure will best
suit Astellas, which is currently working on various new modalities and biology under our Focus Area
approach globally at each laboratory. We also have embedded in our organization a mechanism for
companies to evolve from the startup level to clinical-stage bio-ventures, survive shakeouts, and achieve
growth. By rendering the organization, which is quite isolated from the outside world, closer to an
environment regulated by external market principles, we wanted our researchers to have a keen awareness
that Astellas is competing within a giant bio-ecosystem that surrounds the outside world. We also created
departments responsible for developing new modalities and drug discovery platform technologies. We seek
to create new programs by utilizing developed platform technologies anticipating medium-term
technological progress.
In FY2022, we will do our utmost to resume the ASP7317*7 clinical trial, which has been suspended as
of end-July, and to elucidate the serious adverse events reported in clinical trials for AT132 and AT845*8. We
also will take further steps to expand our pipeline, especially in the areas of TPD, Immuno-Oncology, and cell
therapy. In addition to expanding our pipeline, we will be on the lookout constantly for external
collaborators to aid in acquiring the requisite technology platforms. In addition to strengthening our current
Primary Focus*9, we will also promote alliances and acquisitions in a well-balanced manner for sustainable
development in the future.
Reorganization has elicited a positive response from researchers and I can see a different look in their
eyes. The speed of decision-making at the front line also has shown tangible improvement. Going forward,
we will remain proactive in implementing activities designed to alter researchers’ mindsets and actions and
foster an organizational culture, in the hope that reorganization aids us in continuously creating innovative
new products and delivering VALUE to patients.
*1 ASP3082: A protein degrader targeting KRAS G12D mutant. KRAS mutations are found in refractory pancreatic and lung cancer, for example,
and mutations other than G12D (e.g., G12V) have been identified.
*2 ASP2138: A bispecific antibody targeting Claudin 18.2 and CD3, positioned as a successor to zolbetuximab.
*3 Targeted protein degradation: A new drug discovery method that uses an intrinsic proteolytic mechanism to inhibit the function of the
targeted protein.
*4 Please refer to P.44 for details of our DX initiatives.
*5 Compound optimization period: The period taken for a hit compound (a compound active against a target molecule) to become a drug
candidate compound (a compound having suitable properties as a pharmaceutical).
*6 Agile organization: An organization in which members with various expertise get together to iterate by trial and error to continuously
improve solutions. There, highly delegated mission-specific units make quick decisions and act autonomously.
*7 ASP7317: A cell therapy program for targeting dry age-related macular degeneration (AMD).
*8 AT132, AT845: Gene therapy programs for patients with X-linked myotubular myopathy and Pompe disease, respectively.
*9 Primary Focus: Research and development areas where Astellas is investing proactively under the Focus Area approach.
Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Strategic Goal 2 Translate innovative science into proven VALUE
Progress of Strategic Goal 2
Biology
Pathophysiology-
characterized
Modality/
Technology
Versatile technology
Disease
Disease with high unmet
medical needs
Regeneration, Mitochondria, Genetic
Regulation, and Immuno-Oncology.
We also identify the combination of
biologies, modalities/technologies,
and diseases that may become
Primary Focuses in the future.
Primary Focus Candidate
Targeted protein
degradation
Primary Focus
Blindness &
Regeneration
Mitochondria
Immune Homeostasis
Genetic Regulation
Immuno-Oncology
Focus Area Approach
Focus Area Approach is designed to
identify drug discovery opportunities
flexibly and efficiently by combining
innovative biologies and modalities/
technologies to address diseases with
high unmet medical needs.
Primary Focus is a specific focal
point within our Focus Area Approach
where a lead and follow-on projects
show a clear R&D path with expected
VALUE for patients. Based on criteria
such as higher scientific validity and
identification of leads and follow-on
programs, we are currently working
on 4 Primary Focuses: Blindness &
Biology, Modality/Technology of interest
Targeted Therapeutics for Auditory
Regeneration
Autophagy
Bispecific Immune Cell Engager
Direct Reprogramming ( Transdifferentiation)
Engineered Bacteriophage
Innate Immunity (Innate Lymphoid Cells)
Innate Immunity (Microglia)
Human Genetics
Organizational Structure
In FY2021, Astellas substantially revamped
the research organization structure.
Previously, the Drug Discovery Research
organization was hierarchical and func-
tion-led, and acquired bio-ventures were
operating independently. This approach
was not efficacious for swift decision
making in new technology fields and
creating overall synergy. To address this
issue, a bio-venture-like agile research
model was introduced with highly
delegated mission-specific product
creation units, and all research organiza-
tions were consolidated under the Chief
Scientific Officer (CScO), driving synergy
among the various organizations.
Furthermore, as 2 different organiza-
CEO
Acquired
Bio-venture
Acquired
Bio-venture
Acquired
Bio-venture
DDR Head
DDR
Multiple functions
including the
early-stage
partnering
department
+
tions handled early- and late -stage
partnering opportunities respectively,
these partnering functions were integrated
into a new Business Development
organization.
The new research organization
structure can be divided into 3 groups
based on their key mission: Product
Creation Units, Applied Research &
Operations, and Administration Functions.
Centered on the Product Creation Units,
which are a collection of in-house and
acquired bio-ventures, subject matter
experts with strong expertise within
each unit engage closely with external
partners to provide VALUE for patients
across the world.
CScO
Administration
Partnering*
Applied Research
Platform
Regulatory
Translational
In-house
Bio-venture
Acquired
Bio-venture
Acquired
Bio-venture
Acquired
Bio-venture
* Integrated into a new Business Development division
under Chief Strategy Officer
The new research organization
Chief Scientific Officer
(CScO)
Research Strategy &
Communications
Affiliate Engagement
Product Creation Units
Applied Research & Operations
Administration Functions
AIRM* 1
Universal Cells
Xyphos
Immuno-
Oncology
AGT* 2
Mitobridge
Discovery
Accelerator
Applied
Research &
Operations
*1 AIRM: Astellas Institute for Regenerative Medicine
*2 AGT: Astellas Gene Therapies
Product Creation Units
41
Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Strategic Goal 2 Translate innovative science into proven VALUE
Progress of Strategic Goal 2
FY2021 Progress in Focus Area Approach
We intensively advanced evaluation
of multiple projects from Focus Area
Approach, but didn’t achieve any
PoC* 1 in FY2021. However, 4 projects
(ASP1570, ASP2138, ASP8731, and
ASP3082) entered clinical stage.
ASP3082 is a project that achieved
IND* 2 application in 1 year from
endorsement as a new drug candidate.
Among projects that already
have entered clinical trials, we have
succeeded in dosing the first subject
in a Phase II study of ASP7517 in
acute myeloid leukemia and myelo -
dysplast ic syndro me, and a Pha se
I study of the same investigational
drug in solid tumors. Similarly, we
have dosed the first subject in a
Phase II/III study of ASP0367 in
primary mitochondrial myopathies.
We continue to drive new drug
candidates from our Focus Area
Approach.
*1 PoC: Proof of concept (key clinical data supporting a decision to initiate late-stage development)
*2 IND: Investigational New Drug
Lead project pipeline
Outlook for FY2022 onward
Among lead projects that already
are at the clinical stage, in FY2022,
we expect PoC judgement for the
artificial adjuvant vector cell (aAVC),
ASP7517. In the third quarter of
FY2022, we anticipate submitting a
response to the clinical hold placed
by the FDA*5, with a view to resuming
the clinical trial evaluating AT132.
We furthermore plan to initiate
clinical trials on an intravenously
administered oncolytic virus as a
*5 FDA: US Food and Drug Administration
lead project, and on a checkpoint
inhibitor, bispecific immune cell
engager, and protein degrader as
follow-on projects.
Based on advances made in
FY2021 and planned progress in
FY2022 onward, we are aiming for
PoC judgements on a total of 24
projects by the end of FY2025. Our
goal is to build a robust post-PoC
portfolio from our Primary Focus
pipeline by the end of FY2025.
Primary Focus
Biology/Modality/Technology*3
Lead project
Modality
FY2022
FY2023
FY2024-FY2025
No. of projects aiming
PoC by end FY2025*4
Genetic
regulation
Gene replacement (AAV)
Gene regulation (AAV)
Checkpoint
Artificial adjuvant vector cell (aAVC)
Immuno-
Oncology
Oncolytic virus (intratumoral)
Oncolytic virus (systemic)
AT132
AT845
ASP1570
ASP7517
ASP9801
Gene
Gene
Gene
Small molecule
Other
Gene
Gene
Bispecific immune cell engager
ASP2138
Antibody
Blindness &
Regeneration
Cancer cell therapy (UDC)
Cell replacement
Cell replacement (UDC)
Gene regulation (AAV)
ASP7317
Gene regulation & mitochondrial biogenesis
ASP0367
Mitochondria
Mitochondrial stress
ASP8731
Primary Focus
Candidates
Mitochondrial transfer
Immune modulating/regulatory cells
Tissue-specific immune regulation
Targeted protein degradation
ASP3082
Cell
Cell
Cell
Gene
Small molecule
Small molecule
Cell
Cell
Antibody
Small molecule
Timeline for PoC judgement under discussion
IND
PoC
IND
IND
IND
42
4
12
3
4
1
Total
24
Stage of the most advanced project
in the category
Discovery/Preclinical
Pre-PoC
Post-PoC
PoC
PoC judgement
IND
IND
Phase 1 entry of lead project
Phase 1 entry of follow-on project
*3 Not exhaustively listed.
*4 Estimated based on standard development
timelines, assuming 100% probability of success.
(as of July 2022)
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Strategic Goal 2 Translate innovative science into proven VALUE
Progress of Strategic Goal 2
Primary Focus: Blindness and Regeneration
Our mission for Primary Focus Blindness
& Regeneration is to identify, develop
and deliver next-generation treatments
to restore sight for patients with eye
diseases. Utilizing our in-house ophthal-
mology expertise and regenerative
medicine capabilities, we seek to bring
transformational changes in the man-
agement of devastating eye diseases.
Vision loss caused by eye diseases
affects over 160 million people globally
and can have a profound long-term im-
pact on quality of life. Many of these
diseases have few or no effective treat-
ment options. Through cell and gene
therapies, we aim to restore and preserve
the critical vision-supporting cells in the
eye through the discovery of new treat-
ment options to protect against declining
vision and even restore lost sight.
The eye
Cornea
Retina
Corneal endothelium: Keeper of transparency
Corneal dystrophy
Ganglion cell: Electric wire to the brain
Glaucomatous optic neuropathy
Corneal endothelium
Ganglion cell
Not disclosed
Retinal pigment epithelium: Guardian of photoreceptor
GA secondary to AMD, Stargardt disease
ASP7317
Not disclosed
Photoreceptor: Converter of light into signal
Retinitis pigmentosa
Photoreceptor
Modality:
Pluripotent cell-derived
cell therapy
AAV-based
gene therapy
In Primary Focus Blindness & Regeneration, we are partnering up with top-class venture
companies and academia to build a highly competitive pipeline.
Primary Focus: Mitochondria
Our mission for Primary Focus Mitochondria
is to become the global leader in discover-
ing, developing, and bringing to market
mitochondria biology-based medicines that
provide tangible value to patients, clinicians,
and healthcare systems.
Mitochondria are specialized organ-
elles in cells that have their own mater-
nally inherited DNA (mtDNA). They are
present in almost all human cell types
and play essential roles in energy pro-
duction and in processes such as metab-
olism and cell signaling. Mitochondrial
dysfunction is associated with diseases
of the kidneys, liver, muscles, central
nervous system, eyes, and ears.
Many of these diseases have signifi-
cant unmet medical needs and few
treatment options. By targeting mito-
chondria in our research, we have the
potential to create entirely new ways of
treating diseases associated with mito-
chondrial dysfunction.
Each asset has the potential to be devel-
oped for multiple diseases and indications
due to the broad impact of mitochondrial
dysfunction in the human body.
Gene regulation and
mitochondrial biogenesis
ASP0367
Research projects with
Nanna Therapeutics, Ltd.
Mitochondrial stress
ASP8731
Research projects
mtDNA
ROS
CELL
MEMBRANE
Metabolism (NAD+)
enhancement and increased
mitochondrial
membrane potential
Research projects including in
partnership with Nanna
Therapeutics, Ltd.
Mitochondrial transfer
Research partnership with
Minovia Therapeutics, Ltd.
Mitochondrial dynamics
Research projects
mtDNA: Mitochondrial deoxyribonucleic acid
ROS: Reactive oxygen species
ATP: Adenosine triphosphate
NAD+: Nicotinamide adenine dinucleotide
AAV: Adeno-associated virus, GA: Geographic atrophy, AMD: Age-related macular degeneration
NUCLEUS
ATP production
Pipeline (as of Aug 2022)
* Acquired (current programs classified as ‘in-house’)
Pipeline (as of Aug 2022)
* Acquired (current programs classified as ‘in-house’)
Program
Modality/Mechanism
Indication
Current phase
Origin/Partner
Program
Modality
Mechanism
Target indication
Current phase
Origin
ASP7317
RPE cell
Geographic atrophy secondary to AMD,
Stargardt disease
Phase 1
ASP1015
Gene therapy (AAV )
Glaucoma
ASP1819
ASP2020
Photoreceptor rescue cell
Retinitis pigmentosa
Universal donor cell (UDC) RPE
Dry AMD, Other macular degeneration
Preclinical
Not disclosed Ganglion rescue cell
Glaucoma, Optic neuropathy
Not disclosed
Corneal endothelial cell
Corneal dystrophy
Not disclosed
Vascular progenitor cell
Vascular disease
Discovery
Discovery
Discovery
Preclinical (IND
planned in 2024)
Preclinical
*
*
ASP0367
Small molecule
(oral formulation)
PPARδ modulator
Primary mitochon-
drial myopathy
Duchenne muscular
dystrophy
Phase 2
Phase 1
ASP8731
Small molecule
BACH1 inhibitor
Sickle cell disease
Not disclosed
Small molecule
Not disclosed
Not disclosed
Small molecule
Not disclosed
Not disclosed
Not disclosed
Phase 1 (Phase 1
study FSFT in March
2022)
Discovery
Discovery
Discovery
*
*
*
Not disclosed Gene therapy (AAV )
Dry AMD, Other macular degeneration
Discovery
University of Pittsburgh
Not disclosed
Cell therapy
Mitochondrial Transfer
Not disclosed
RPE: Retinal pigment epithelial
PPARO: Peroxisome proliferator-activated receptor delta, BACH1: BTB and CNC homology 1, FSFT: First subject first treatment
43
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Strategic Goal 2 Translate innovative science into proven VALUE
Progress of Strategic Goal 2
Primary Focus: Genetic Regulation
One of the most
active preclinical
developers, with
16 3
gene therapy
candidates in
development
cutting-edge laboratory
and manufacturing
facilities
400+
Passionate, highly
skilled scientists,
researchers and
operational experts
END-TO-END
CAPABILITIES
incorporating research,
development,
manufacturing and
commercialization
Active partnerships
with leading industry
and academia,
including Dyno
Therapeutics to develop
next-generation (AAV)
vectors
Our mission for Primary Focus Genetic
Regulation is to discover, develop and
deliver transformative gene therapies for
patients with genetic diseases. Alongside
our world-renowned partners and with
competitive capabilities across the value
chain we are working to build a portfolio
of potentially lifechanging gene therapies,
with a long-term goal to deliver transfor-
mational VALUE for patients.
Often present from birth and affect-
ing young children, nearly 7,000 human
diseases are caused by mutations or
deficiencies in the genetic code. By
targeting disease at the genetic level,
Pipeline (as of Aug 2022)
we can significantly improve outcomes
for serious and potentially fatal diseases
via a single or few treatments that
replace or regulate the faulty gene.
The rapidly evolving field of gene
therapy cannot be navigated alone. We
collaborate with world-renowned aca-
demic and industry partners to overcome
the complex challenges of gene therapy
research and development. We continually
investigate and assess new partnerships
that could enhance our diverse portfolio,
as well as those that can offer unique
technology or research perspectives to
better support patients.
Program
Mechanism
Target indication
Current phase
Origin/Partner
AT132
AT845
AT808
AT466
MTM1 gene replacement
X-linked myotubular myopathy
Phase 2 - Pivotal
GAA gene replacement
Pompe disease
FXN gene replacement
Friedreich’s Ataxia
Phase 1
Preclinical
Vectorized exon skipping/vectorized
RNA knockdown for DMPK
Myotonic dystrophy
Discovery
(Not disclosed) UBE3A restoring
Angelman Syndrome
MDL-201
Not disclosed
MDL-202
Not disclosed
Muscle disease
Muscle disease
Discovery
Preclinical
Preclinical
MTM: Myotubularin, GAA: Acid alpha-glucosidase, RNA: Ribonucleic acid, DMPK: Myotonic dystrophy protein kinase, FXN: Frataxin
Primary Focus: Immuno-oncology
Our mission for Primary Focus Immuno-
Oncology is to deliver innovative treatment
options to patients and ultimately cure cancer.
To that end, we are working to maximize our
innovative capabilities while building a
strong network of external collaborations.
As many as 80 percent of patients are
Our early-stage platforms are built to
trigger an anti-tumor immune response by
stimulating multiple immune functions.
Through strategic external collaborations and
acquisitions, we have established a robust and
competitive Immuno-Oncology pipeline with
multiple assets in the clinical stage.
estimated to be refractory
(non-responsive) to immune
checkpoint inhibitors or to
relapse (fail to maintain a re-
sponse) during treatment. In
Primary Focus Immuno-Oncology,
our strategy is to target multiple
aspects of the immune response
to the cancer simultaneously.
Pipeline (as of Aug 2022)
Acquired immune system
Innate immune system
The Cancer Immunity Cycle*
Priming and activation
Oncolytic virus
GITR
Cancer antigen
presentation
aAVC
Release of cancer cell antigens
Oncolytic virus
GITR
aAVC
Amplification and
activation of innate
immune response
Cell therapy
Infiltration of T cells into tumors
Bispecific immune cell engager
Recognition of cancer cells
by T cells
Bispecific immune cell engager
Cell therapy
Killing of cancer cells
Bispecific immune cell engager
* Chen DS & Mellman I. Immunity. 2013;39(1):1-10 and Demalia O. et al. Nature.
2019;574(7776):45-56.
aAVC: Artificicial adjuvant vector cell
Modality
Oncolytic virus (OV )
aAVC
Bispecific immune cell
engager
Program
ASP9801
ASP1012
ASP7517
ASP0739
ASP2138
Mechanism
OV IL-7, IL-12
Current phase
Partner
Phase 1
Systemic OV Leptin-IL2 fusion
Preclinical
WT1
NY-ESO-1
Anti-Claudin18.2 x and anti-CD3
bispecific antibody
Phase 2
Phase 1
Phase 1
Not disclosed
Probody® T cell engagers
Discovery
Not disclosed
Bispecific immune cell engager
Preclinical
Small molecule
ASP1570
DGKζ inhibitor
ASP2802
CD20 convertibleCAR-T
Cell therapy
Not disclosed
Mesothelin HiT TCR-T
Not disclosed
convertibleCAR-NK
Phase 1
Preclinical
Discovery
Discovery
IL: Interleukin, aAVC: Artificial adjuvant vector cell, DGK: Diacylglycerol kinase, CAR: Chimeric antigen receptor, TCR: T-cell receptor,
HiT: HLA (human leukocyte antigen)-independent TCR, NK: Natural killer, WT: Wilms tumor 1, NY-ESO-1: New York esophageal
squamous cell carcinoma 1, CD20: B-lymphocyte antigen CD20
44
Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Strategic Goal 2 Translate innovative science into proven VALUE
Digital Transformation
Aims of our digital transformation (DX) initiatives
The pharmaceutical industry handles vast amounts
of data throughout its entire value chain, from
drug discovery(research), development, and
manufacturing, to commercial and the post-mar-
keting maximization of our product value. The
impact that DX will have on the company’s future
is huge, so Astellas is pursuing DX across all areas
of the value chain.
In R&D of prescription drugs, for example, it is
important to achieve even a small reduction by
improving the probability of R&D success and
shortening drug development periods as a huge
amount of money is spent on drug development.
As the potential impact of DX is estimated that it
would possibly reduce the cost of R&D by about
60% and shorten the development period by
about 2.4 years*1 over the next 15 to 20 years, the
acceleration of DX would greatly benefit the
whole industry.
Astellas’ approach to DX is much more than
just streamlining operations through digital
technology. We have positioned DX as one of the
Critical Enablers accelerating execution of our
Corporate Strategic Plan 2021 (CSP2021). Astellas’
DX Vision is to “become a world-class Intelligent
Enterprise that accelerates digital transformation
to turn innovative science into VALUE for patients”,
and we have identified 4 levers (sources of value)
centered around Digital x Data to realize our DX
vision: “Sense,” “Analyze,” “Automate,” and “Engage.”
By combining these 4 levers with the scientific
knowledge that we have accumulated, and
through the “best mix” of our people and digital
technology, we seek to pursue DX in a way that
only Astellas can. The type of DX we aspire to
implement is not the one where digital
technologies replace people but rather the one
where digital technology works with people,
complementing each other in areas of mutual
strength. In this manner, we aim to achieve a
superior pharmaceutical value chain and establish
competitive advantages.
DX Vision
Become a world-class Intelligent Enterprise that accelerates digital
transformation to turn innovative science to VALUE for patients
• Establish competitive advantages by adding our accumulated scientific
Approach
knowledge to the 4 levers (sources of value) of Digital x Data
• Best mix of people and digital
Use sensors to collect all
events as data
Science
Sense
Analyze
Utilize and analyze all data
to anticipate the future
and engage in bold and
accurate decision-making
early on
Levers
Use a combination of
digital and analog to
connect people across
time and space
Digital
Data
Engage
Automate
Use digital for high
quality, fast operations
Case
“Mahol-A-Ba” drug discovery platform
Handling iPS cells requires the practical skills and trained eyes of experienced researchers with subject
matter expertise. However, the number of skilled researchers is limited, and even highly skilled
researchers are subject to the possibility of human error, alongside a limitation on operating time.
Astellas developed Mahol-A-Ba as a solution to these challenges. Mahol-A-Ba is a “Human-in-the-
Loop” drug discovery platform, with no parallels worldwide, that integrates humans, AI, and robots. In
this platform, our robot Maholo conducts cell culture and differentiation in its role as the “Expert Arm,”
taking over the tasks previously performed by researchers. Our “Expert Eye” robot then evaluates the
activity of differentiated cells and their pharmacological effects.
In evaluating the activity of differentiated cells and their pharmacological effects, Mahol-A-Ba can
conduct 100 to 1,000 times more experiments in the same amount of time compared to humans,
even a skilled researcher, and can also continue experiments over long periods of time with high
precision and reproducibility. Because researchers can operate Mahol-A-Ba remotely, there has been
no need to halt experiments due to restrictions imposed under the COVID-19 pandemic on going to
the laboratory and indeed leaving the home at all.
In addition to applying AI and robotics in cell manipulation by Mahol-A-Ba, we can also utilize AI
in reflecting researchers’ ideas in pharmaceutical compound property prediction and design. We aim
to deliver superior pharmaceutical products to patients in the shortest possible time by combining
the results of AI analysis with humans’ experience and knowledge to inform researchers and allow
them to make comprehensive judgements, essentially integrating humans x AI x robotics.
The use of AI and robotics is a new approach to accelerating the speed of R&D, reducing costs,
and improving drug quality, enabling us to do things that previously were impossible for humans to
achieve on their own. We will utilize these technologies globally in small molecules and antibodies,
as well as in new modalities such as cells and genes, to realize agile drug discovery research.
Past
# Samples
>10
Present
>1,000 – >10,000
“Mahol-A-Ba”
Experiment
Manual
“Expert Arm” robot
Maholo
AI
Machine Learning
“Expert Eye”
robot
Astellas’ unique
system*2
*1 Source: “Paradigm of New Drug Discovery through Technology Advance” (Deloitte Tohmatsu Consulting LLC) “With advances in
(digital) technology, it will be possible in 15 to 20 years from now to reduce the cost of pharmaceutical research and
development by about 60% and shorten the development period by about 2.4 years.”
45
*2 Image source: Beckman Coulter, Inc., Yokogawa Electric Corporation
Nov 2017–
Mar 2019–
Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Strategic Goal 3
Rx+ Business
Our main areas of progress in the Rx+ business during
FY2021 included the initiation of a sales pilot of
Fit-eNce Home, commercialization of AI-based
MYHOLTER II ECG analysis service, a business alliance to
initiate a sales pilot of disposable Holter ECG device
“EG Holter”, and the topline results from the Phase II
trial of the imaging agent pudexacianinium chloride
(ASP5354) used to visualize the ureters. As for the
MYHOLTER II ECG analysis service, we will further
improve the system’s diagnostic accuracy by conducting
additional learning using more ECG data. As for
ASP5354, based on the positive results, a Phase III trial
is scheduled to start during FY2022, and we plan to
file a regulatory submission in the United States
during FY2023.
Relationship to Material Issues
• Access to Health
• Fulfilling unmet medical needs by creating novel
healthcare solutions
46
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Strategic Goal 3 Rx+ Business
Message from the Head of the Rx+ Business Accelerator
Q1
What is Astellas’ aiming for in
its Rx+ initiatives?
Q 4
What was accomplished, and what needs to be addressed
in the second year of CSP2021?
We are expanding Astellas’ ability to
provide VALUE to patients, across the
patient journey, through exploring new
and innovative science and technologies
that are not pharmaceutical in nature.
We are taking a bold approach by seeking
to create new and sustainable businesses
that are independent from our existing
pharmaceutical business.
Richard Cassidy
Senior Vice President,
Rx+ Business Accelerator
Q2
How do you see the Rx+ business unfolding over the longer term?
We have a broad portfolio of projects in incubation and acceleration stages. The exciting
development in the coming 2-3 years is that some of those projects will progress to being
fully commercialized businesses. In parallel, we will continue to innovate and seek new
ideas for future businesses.
In the second year of CSP2021, we will be building on these pilot sales from June 2022 and
move towards full commercialization. In addition, we will move other late-stage programs
to cross the threshold of achieving sales. These are critical steps as we move towards our
goal of achieving profitability from Rx+ activities by FY2025.
Q 5
CSP2021 set out a goal of making the Rx+ business the backbone of Astellas in the
coming decade. In the first year out, what changes do you see in the Company as an
Rx+ organization, and in the general mood of the people who are working?
CSP2021 goals for Rx+ have made us focus our activities even more on opportunities that
have the potential to grow into new businesses and on pushing our teams to move to
commercialize with great speed. The Rx+ teams are dedicated to providing VALUE to
stakeholders through new and innovative solutions. As we move our programs forward,
we are always learning from our activities because many things we are doing are new to
Astellas. I see a greater understanding of Rx+ priorities across colleagues in Astellas and a
greater willingness to support us in achieving our goals.
Q3
What has the Company focused on since the launch of CSP2021?
Q 6
What Rx+-related events are you most looking forward to in FY2022?
In Rx+ we are pushing hard to commercialize our later-stage business opportunities. We
achieved 2 significant milestones since the launch of CSP2021. As part of pilot commercial
activities, we made Astellas’ first device sale and Astellas’ first service-based sale.
Every day working with the Rx+ Business Accelerator team is special! We are all highly
motivated to provide VALUE to patients and we are always breaking new ground and learning
something. It is a very exciting part of Astellas to work in! We have so many programs that
will progress during FY2022 that it would be unfair to single out any in particular.
47
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Strategic Goal 3 Rx+ Business
Progress of Strategic Goal 3
Explanation of Rx+
Strategic Goal 3 calls for Astellas to
advance the Rx+ business, which is
defined as a business that combines
the expertise and knowledge of Astellas,
cultivated through its Rx business, with
technology in different fields to offer
new healthcare solutions. Our aim is to
create new revenue streams separated
from our core Rx products. We will
provide VALUE to patients across the
patient journey not only for prevention
and treatment through conventional
medical drugs (Rx) but also through
diagnosis and treatment support.
Astellas aims to realize “a world
where people can live mentally and
physically healthy lives and be true to
themselves through healthcare
solutions based on scientific evidence.”
To this end, the Rx+ business will create
new businesses that provide the
following value propositions.
• Prevent disease onset and slow progression by using personal data
• Expand options for people with limited access to current therapeutics
• Support active living by enhancing physical and sensory functions
Positioning of the Rx+ Business
Patient
Journey
Diagnosis/
Treatment
support
Prevention/
Treatment
New medical solutions
that contribute
positively to the entire
patient journey
+ M edical solutions
+ Treatment solutions
New treatment solutions
that replace conventional
therapy or add new VALUE
Medical drugs
New technology
Healthcare technology
48
Programs Under Way
Connecting Medical
to Exercise
– Value creation and provision through "Astellas x
Fitness x Medical"
– Toward a society in which people can enjoy
becoming healthy.
By exploring VALUE creation and provision through combining exercise and clinical
evidence, built on Astellas’ strengths, s"uch as understanding disease and physicians’ and
patients’ needs, scientific knowledge, and a network with healthcare providers, we will
realize a society in which people can enjoy becoming healthy.
Bioelectronics using
iota Technology
– Utilizing iota Biosciences' platform technology for
tiny wireless medical implantable devices
– Aiming for another way to realize innovative
medical solutions
Bioelectronics is an interdisciplinary field of biology and electronics that uses implantable
devices to obtain biological data or transmit signals into organisms. Astellas will utilize this
technology to implant the tiny wireless medical devices of iota Biosciences in organisms and
harness their feedback control to aim for another way to realize innovative medical solutions.
Image-guided
Precision Surgery
– Maximize patient outcomes using image-guided
technology
– Realize precise surgical procedures with drug and
device combination
Image-guided surgery can be achieved by fusing detecting devices and other medical
device technology with imaging agents and other pharmaceutical technology, to support
surgeons and patients. We aim to realize more precise and safer surgical methods.
Clinically Relevant Holistic
Solutions and Mobile
Healthcare Solutions
– Collect and analyze medically and clinically useful
information through digital technology
– Provides a personalized treatment and continuous
interaction with healthcare providers
Mobile healthcare solutions can collect and analyze medically and clinically useful
information through digital technology to optimize and provide data to individual
patients and healthcare professionals. This is a service which connects patients and
healthcare professionals digitally and provides new treatments.
Innovation in
Management of Heart
Disease Patient
– An eco-system which supports home care of heart
disease patients
– Consists of simple and cost-effective novel
sensing devices
When in-home care management was left up to patients, the lack of devices was an issue.
The Heart Disease Patient Support System is an eco-system that supports the in-home
management of patients with heart disease by linking data with new monitoring devices
that are easy to use and cost-effective.
Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Strategic Goal 3 Rx+ Business
Progress of Strategic Goal 3
Progress and Outlook
Main areas of progress in the Rx+
business in FY2021 included the initiation
of a sales pilot of Fit-eNce Home,
commercialization of AI-based MYHOLTER
II ECG analysis service, a business alliance
to initiate a sales pilot of disposable
Holter ECG device "EG Holter", and the
topline results from Phase II trials of the
imaging agent pudexacianinium
chloride (ASP5354) used to visualize
the ureters.
AI-Based Holter ECG Testing Service
MYHOLTER II service realizes the auto-
matic analysis of ECG data by using a
proprietary AI-assisted algorithm. It was
jointly developed by Astellas and M.
Heart. M. Heart has obtained certification
for EG Holter and MYHOLTER II as a
medical device (Class II). Because it is
cloud-based, MYHOLTER II allows
healthcare professionals to conduct
ECG data analysis from anywhere.
EG Holter is a Holter electrocardio-
Measures
Taken
Event
Time to
Achievement
Fit-eNce
Initiated pilot marketing
of Fit-eNce Home
service that can be
implemented at home
Sep 2021
MYHOLTER II
Service
commercialization
Jul 2021
EG Holter
Initiate sales pilot
Jun 2022
pudexacianinium
chloride(ASP5354)
Topline results for
Phase II study
Nov 2021
graph designed and developed by
Nitto. Because it is a disposable device,
it is hygienic and does not require
maintenance. It is 6 mm thick, 11 g in
weight, has no cords, and is water
resistant (IPX4). It is easy to attach and
remove. Astellas, Nitto and M. Heart
initiated a sales pilot of EG Holter for the
Japan market. Data obtained by EG
Holter will be analyzed by MYHOLTER II.
Order
Devices can be stocked.
No need for complicated
scheduling.
Wearing
Measurements can be
taken from the patient’s
first visit.
Patient registration is done
by reading a 2D code on a
smartphone.
Posting
After measurements,
patients return the device
by postal mail.
No need to visit a hospital
to return the device.
Analysis
After the device arrives at
the reception center, the
data will be analyzed
quickly by AI.
Result
confirmation
After completing the AI
analysis, the medical
institution will be notified
of the results.
Results can also be
confirmed on the cloud.
49
With the ECG testing service, after
measurement, patients send the device
to the reception center by postal mail,
eliminating the need to return the
equipment back to a medical institution.
Medical institutions can also see results
online via MYHOLTER II, resulting in
reduction of the burden on both
patients and medical institutions.
Going forward, we will improve
the system’s diagnostic accuracy by
conducting additional learning using
more ECG data obtained.
Imaging Agent Pudexacianinium Chloride That Guides Precision Surgery
The compound pudexacianinium chloride
(ASP5354) fluoresces upon excitation with
near-infrared light. When administered
prior to surgery, the compound enables
surgeons to confirm the position of the
ureter during surgery. This holds the
promise of reducing the risk of accidental
injury to the ureter during surgery and of
shortening surgery times.
ASP5354 received Fast Track
Designation from the US Food and Drug
Administration (FDA) in 2020. The Fast
Track Designation promotes the acceler-
ation of development and testing of
drugs for the treatment of serious or
potentially life-threatening diseases
with high unmet medical needs. The
designation raises hopes that ASP5354
will be put into actual use earlier.
In a Phase II study completed in
November 2021, visualization of the
ureter was confirmed at different does of
the imaging agent. Results showed that
visualization could be sustained until the
completion of surgery. In addition, no
major safety concerns were observed.
Based on these positive results, A
Phase III study is scheduled to start
during FY2022, and we plan to file a
regulatory submission in the United
States during FY2023. Moreover, since
visualization of the ureter using
ASP5354 also requires a near-infrared
light emitter, we are exploring collabo-
ration with a device manufacturer as we
move toward commercialization.
Ureter Visualization at 30 Minutes Post
pudexacianinium Administration and at
End of Surgery
0.3 mg
1.0 mg
3.0 mg
30 min
End of
surgery
Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Strategic Goal 4 Deepen our engagement in sustainability
Astellas is committed to our mission of sustainable
enhancement of enterprise value in alignment with our
raison d’être, "To contribute toward improving the health
of people around the world through the provision of
innovative and reliable pharmaceutical products." In other
words, for Astellas, contributing to societal sustainability
means the execution of our business philosophy.
While leveraging our strengths and capabilities, we
will deliver VALUE to society by creating innovative
healthcare solutions that improve access to health and
outcomes* for patients. We believe that our innovations
will play a part in improving the sustainability of
society. This will build trust from society, which will, in
turn, also make Astellas more sustainable.
In FY2021, Astellas has updated our Materiality Matrix to
guide our sustainability efforts, selecting key issues from
the perspective of importance for society and Astellas.
We then prioritized the material issues (materiality) and
will formulate action plans for each materiality identified,
which will contribute to the improvement of sustainability
through company-wide efforts.
* Outcome includes not only the safety and efficacy of treatments, but also the minimization of
the burdens on patients caused by the complexity of treatments and the improvements in
quality of life (QOL).
50
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Strategic Goal 4 Deepen our engagement in sustainability
Message from the Head of the Sustainability Division
We will address materiality
as One Astellas to evolve
sustainability for both society
and Astellas.
Shingo Iino
Vice President,
Sustainability
A year of deepening our engagement in sustainability
Companies today are expected to manage their operations with an awareness of sustainability.
At Astellas, we feel that each year brings higher expectations of our sustainability efforts. Under
Among the material issues, we will focus on “Access to Health”. With our VISION to be “On
the forefront of healthcare change to turn innovative science into VALUE for patients”, we will
promote initiatives that use our capabilities and assets, while improving access to Astellas
products and to products under development in our portfolio.
Our sustainability efforts cannot be completed by the Sustainability Division alone and
all divisions and Astellas employees need to work together. In order to do so, we made a
concerted effort to have engagement among Top Management about our initiatives. As an
example, in FY2021, sustainability issues were reported to the management and discussed
10 times at the Executive Committee (including quarterly reporting meetings) and 6 times
at the Board of Directors.
In FY2022, we will further strengthen our advocacy activities on sustainability. As well as
dialogues with investors and other external stakeholders, we will actively introduce Astellas
initiatives to our employees to deepen their understanding. At the same time, we will create
opportunities for gathering ideas so that more employees than ever can take part in our activities.
Becoming a company whose Raison D’être is recognized,
a company supported by people around the world.
these circumstances, we have set “deepen our engagement in sustainability” as one of the
We believe that our efforts to improve Access to Health will not only deliver more VALUE for
Strategic Goals of Corporate Strategic Plan 2021 (CSP2021). In FY2021, the first year of the plan,
patients but will also help reduce the burden on their families and even on the healthcare
we carried out various initiatives to achieve this goal.
system. As a cutting-edge VALUE-driven life science innovator, we aim to create innovative
As key accomplishments in FY2021, we (1) refreshed our Materiality Matrix, (2) created an
healthcare solutions, delivering them widely to patients in need while reducing the burden on
Access to Medicine strategy for Astellas products, (3) selected 4 new HSS (Health System
patients, on their families, and on the healthcare system to help bring about a sustainable
Strengthening) programs, and (4) disclosed the results of scenario analysis aligned to TCFD
society. Through our initiatives to address the key issues we identified, such as Access to
recommendations. In particular, “(1) updating the Materiality Matrix” was a major achievement.
Health, we are envisioning a future in which we earn recognition for our Raison D’être and
Among a range of social issues, it enabled us to identify the key issues and material issues
gain the support of people around the world.
(Materiality) that Astellas should address. We could then present these as a compass to guide
In FY2022, we will continue to work as One Astellas to evolve our efforts on sustainability
our management. After the update, we held discussions with cross-functional members to set
under CSP2021 and to strengthen our engagement with stakeholders through advocacy activi-
each action goal for FY2022. We will carry out these action plans across relevant members to
ties. We also plan to hold the second Sustainability Meeting, following on from last year’s
achieve them.
meeting. We hope that you will continue to take an interest in our efforts to evolve sustainability.
51
Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Strategic Goal 4 Deepen our engagement in sustainability
Progress of Strategic Goal 4
Astellas’ Sustainability
Astellas recognizes our contribution to
social sustainability and earning trust from
society will enhance Astellas’ sustainability.
We have established the Sustainability
Advisory Panel, and Environment, Social
or Governance Working Group (E•S•G
Working Group) led by the Sustainability
division and consisting of cross-functional
members. These organizations promote
the following activities to contribute to
sustainability from a long-term, strategic
and groupwide perspective.
• Improve “Access to Health”
• Contribute to Environmental
Sustainability with Greater Transparency
• Advocate Our Efforts on Sustainability
SUSTAINABILITY GOVERNANCE
Astellas’ Interaction with Society
Engage in the
Sustainability of Society
Trust from Society
Society
Astellas
Fulfill our social
responsibilities as a
pharmaceutical company
Enhance the
Sustainability of Astellas
Raison D’être
Mission
Contribute towards
Improving the Health of
People Around the World
through the Provision of
Innovative and Reliable
Pharmaceutical Products
Sustainable
Enhancement of
Enterprise Value
Executive Committee*1 / Board of Directors*1
President and CEO
Head of Sustainability division
Sustainability Advisory Panel
• Oversee all Astellas’ Sustainability activities
including ESG*2 elements
• Decides on holding a Sustainability Advisory Panel.
Discuss and consider global sustainability issues that
are overarching to ESG such as the change in the
Sustainability Direction.
Chair: Head of Sustainability division
Environment (E)
Working Group
Social (S)
Working Group
Governance (G)
Working Group
• Discuss/exchange information on material issues on E,
S or G, respectively, and create Advocacy strategy.
• Report the outcome to Head of Sustainability.
Oversight: Head of Sustainability Center of Excellence*3
*1 Sustainability annual plan and activities are required to be
reported to the Board Directors. Important matters are
deliberated by the Executive Committee and approval is
obtained by the Board of Directors for each case in
accordance with Corporate Decision of Authority.
*2 Environment, Social, Governance.
*3 Head of Sustainability Center of Excellence in Sustainability
division has responsibility to lead ESG operations globally
under the oversight of Head of Sustainability division.
52
Access to Health
Many people across the globe struggle to receive the medical care
they desperately need. Various factors contribute to this challenging
situation, including a lack of appropriate treatments, healthcare system
challenges, insufficient healthcare information, and poverty. At Astellas,
we recognize these struggles as “Access to Health” issues and are active
in tackling the root causes. We are committed to utilizing our capabili-
ties and technology to provide healthcare solutions and improve
access to health around the world.
Main Hurdles of
Access to Health
• Lack of appropriate treatments
• Insufficient healthcare information
• Healthcare system shortcomings
• Poverty
Environmental Initiatives
Astellas’ Charter of Corporate Conduct states that "recognizing that
harmony between the global environment and our business activities
is prerequisite to our corporate existence, we shall take proactive
measures to conserve the global environment.” For Astellas to continue
to grow sustainably, we need to be conscious of the issues affecting
our local environment and ensure that factors such as energy efficien-
cy, climate change, environmental pollution, and waste disposal, are
central to our environmental initiatives.
Advocacy
Advocacy activities are designed to promote deeper understanding
among our stakeholders regarding Astellas’ efforts on Sustainability. At
the same time, these activities provide an opportunity for us to reassess
how we can contribute to resolving social issues and provide patients
with a better quality of life. Astellas will continue crystalizing and
advocating a Sustainability story which has been developed based on
the updated materiality matrix.
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Strategic Goal 4 Deepen our engagement in sustainability
Progress of Strategic Goal 4
Improving Access to Health
Improving Access to Health: Our Initiatives
Astellas recognizes Access to Health
as a materiality, and through our
VISION to be "On the forefront of
healthcare change to turn innovative
science into VALUE for patients," we
are proactively taking a comprehen-
sive approach to solving this issue
through the 3 methods defined below.
1. Astellas’ core business (Rx, Rx+)
Astellas continues to contribute to the health of patients by researching, developing, and
delivering innovative healthcare solutions to address diseases with high unmet medical needs.
2. Enhancing availability of Astellas products
For patients who have difficulty accessing Astellas therapies for socioeconomic reasons, we are
establishing a mechanism to enhance the availability of Astellas therapies while taking into
consideration the characteristics of various measures and regulations in each country.
3. Collaboration and support for the activities implemented by external partners to improve
Access to Health
In addressing the issues of Access to Health, Astellas promotes collaboration with external
partners and support for their activities by leveraging Astellas’ capabilities and technologies with
external partners.
1. Astellas’ core business (Rx, Rx+)
Since our establishment, Astellas has
continuously strived to create innovative
healthcare solutions and deliver them
to patients who need them. We will
accelerate our research and develop-
ment based on our Focus Area approach
and create diverse healthcare solutions
by combining biologies and modalities/
technologies. In addition, we will promote
the Rx+ business which leverages the
expertise and knowledge of Astellas,
which have been cultivated through its
Rx business, integrates innovative
medical technology with cutting-edge
technology in different fields, and
contributes through the patient journey
(overall medical care, including diag-
nostic, preventive, therapeutic and
prognostic care).
Number of countries and people with access to Astellas’ innovative drugs
(as of February 2022)
Product
Tamsulosin
Tacrolimus
Vesicare
Xtandi
Mirabegron
Xospata
Number of
countries
106
105
86
96
69
33
Astellas’ initiatives improving Access to Health
1. Astellas’ core business (Rx, Rx+)
Number of
patients
approx.
82 mil.
approx.
1.6 mil.
approx.
24 mil.
approx.
0.62 mil.
approx.
23 mil.
approx.
1,300
Astellas’
business
2. Enhancing availability of Astellas products
3. Collaboration and support for the activities
implemented by external partners to
improve Access to Health
53
Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Strategic Goal 4 Deepen our engagement in sustainability
Progress of Strategic Goal 4
2. Enhancing availability of Astellas products
For patients who are unable to obtain
Astellas medicines for social or economic
reasons, we strategically implement
activities to improve access to our phar-
maceutical products from the development
stage to post-launch.
For patients who are unable to partici-
pate in clinical trials but meet certain
criteria, our Early Access Program provides
treatment before marketing authorization.
As a result, more than 900 acute myeloid
leukemia patients in 35 countries have
gained access to our drug, XOSPATA. Our
International Pharmacy Program allows
products that have already been approved
in major countries to be imported and
used in unapproved countries for eligible
patients. Through this program, PADCEV
now has been imported into 50 countries,
Enhancing Availability of Astellas Products
and prescribed to more than 30 patients.
In addition, through our Patient Access
Initiative which allows eligible patients in
some countries and regions to receive
financial assistance in purchasing our
products, XTANDI and XOSPATA have
been made available in 37 and 17
countries, respectively.
We continued to build the capability
to implement data and evidence-based
pricing solutions for our innovative prod-
ucts. These solutions ensure that payers
and healthcare systems pay a fair and
value-based price for our newly launched
medicines. In FY2021, the Company
implemented 4 new Evidence Based
Pricing solutions, with 3 fully implemented
by payers in-country, expanding access to
more patients.
Clinical Development
Market Authorization
Commercialization
Clinical Trial Programs
XOSPATA: over 900 patients in 35 countries
PADCEV: over 270 patients in 7 countries
PADCEV: over 30 patients
in 50 countries
Early Access Program
Post-trial Access Program
XTANDI: over 300 patients in 24 countries
XOSPATA: over 40 patients in 9 countries
PADCEV: over 10 patients in 10 countries
International Pharmacy Program (IPP) & International Import Program (IIP)
XTANDI (37 countries), XOSPATA (17 countries)
Evrenzo (7 countries) and PADCEV (1 country) are available
Patient Access Initiatives
Enhancing the literacy of healthcare professionals and patients through academic and patient societies
3. Collaboration and support for the activities implemented by external partners
to improve Access to Health
In our efforts to improve access to health,
we strive to provide cooperation and
support for the activities implemented by
external partners by combining our capa-
bilities and technologies.
Astellas continues to pursue
collaborative research into new drugs for
the treatment of tuberculosis, utilizing
lead compounds* identified via our “joint
research for exploration of new compounds
for Mycobacterium tuberculosis.” Within a
consortium of partners, Astellas furthermore
has utilized its formulation technology to
develop a pediatric formulation of
praziquantel, the standard treatment for
the parasitic disease schistosomiasis.
In the areas of strengthening healthcare
systems and improving health literacy,
we are funding new projects with external
organizations to impact society where
anticipates synergy with Astellas sustainability.
The Astellas Foundation for Research on
Metabolic Disorders (AFRMD) contributes to
medical and life sciences through the discovery
and nurturing of brilliant young talent and
support for researchers by providing training
and an opportunity to study abroad. Described
below, the Astellas Global Health Foundation
primarily funds initiatives to support the most
underserved communities in low- and
middle-income countries where Astellas does
not have a business presence. Both the
AFRMD and AGHF operate independently of
the corporation.
In March 2022, Astellas pledged to
provide charitable donations to interna-
tional charitable organizations including
National Cancer Society Malaysia and Asia
Cancer Forum, Japan, City Cancer Challenge
Foundation (C/Can), Fred Hollows
Foundation and World Vision, India. The
programs are focused on specific health
issues such as cancer care, eye care and
neglected tropical diseases. Funding from
Astellas is intended to help strengthen
healthcare systems and health literacy in
countries where the company has a
business presence.
* A compound with a physiological activity that meets the predefined criteria discovered through compound screening (search for drug
discovery seeds).
Astellas Global Health Foundation
The Astellas Global Health Foundation (AGHF) is an international philanthropic organization dedicated to supporting
3 key areas: improving access to health, building resilient communities, and providing disaster preparedness support
in underserved global communities. Launched in 2018, the Foundation has awarded nearly $7 million in grants to
support charitable initiatives focused on improving access to health, building resilient communities and providing
disaster support. Through the funding, it is anticipated that the AGHF will impact more than 31 million lives over the
course of 3 years in Kenya, Nepal, Dominican Republic, South Sudan, the Democratic Republic of the Congo, Ghana,
Ethiopia, Nigeria, El Salvador, Honduras, Uganda and Venezuela.
54
Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Strategic Goal 4 Deepen our engagement in sustainability
Progress of Strategic Goal 4
Environmental Initiatives
Climate Change and Energy
Mitigating and adapting to the threat posed
by climate change requires active involvement
by national governments, local governments,
corporations, citizens, and others. Astellas
recognizes that climate change will become
a constraint on conducting sustained
corporate activity and considers it one of
management’s key issues to address.
Astellas has adopted the method for
setting reduction targets recommended by
the Science Based Targets (SBT)*1 Initiative.
This method is designed to achieve the 2°C
Steps toward 2050
Astellas’ Science
Based Targets
Base Year
2015
2018
target of the Paris Agreement, which entered
force in 2016. In November 2018, the SBT
Initiative certified the targets laid out in
Astellas’ Environmental Action Plan.
To address climate change as a manage-
ment issue, we have adopted as an indicator
the 2° C Scenario of the International Energy
Agency (IEA 2DS)*2. We are currently updating
our Environmental Action Plan, setting a
long-term target of net zero emissions by
2050 based on a 1.5°C scenario*3.
Backcasting
2050
Social Goal
2030
2030 Target
SBT Validated
Environmental Action Plan (Climate Change Mitigation Measures) (SBT certified)
Reduce GHG emissions (Scope 1 + Scope 2) by 30% by FY2030 (base year: FY2015)
(Emissions in the base year: 202 kilotons)
Reduce GHG emissions (Scope 3) by 20% per unit of revenue by FY2030
(base year: FY2015)
*1 Greenhouse gas emission reduction targets set by companies 5–15 years ahead, consistent with levels required by the Paris Agreement.
*2 Reference was made to the 2-degree scenario (2DS) of the International Energy Agency (IEA).
*3 Reference was made to the Intergovernmental Panel on Climate Change (IPCC) Working Group I Summary for Policymakers (SPM) of
the Sixth Assessment Report.
55
In FY2021, we invested 900 million yen
in climate change mitigation measures,
mainly in energy-saving measures at each
business facility, the renewal of air condi-
tioning equipment, and the introduction of
LED lighting, yielding a reduction of 1,933
tons of GHG. This represented a reduction
of about 41% in Scope 1 and 2 greenhouse
gas emissions in FY2021 and about 22% in
Scope 3 greenhouse gas emissions.
Progress on Environmental Action Plan
(Scope 1 + 2)
100
(%)
100
90
80
70
60
50
scope 1 + 2
(V.S. FY2015 level)
-18.5
-39.0
-41.3
2015
2019
2020
2021 (FY)
Progress on Environmental Action Plan (Scope 3 / revenue)
FY2015 (Base year)
FY2019
GHG emissions (Scope 3) (Tons)
Revenue (billion yen)
Emission per unit of revenue
(tons/billion yen)
Ratio to Base-year (%)
271,010
1,373
197
—
229,953
1,301
177
-10.5
FY2020
194,534
1,250
156
-21.1
FY2021
200,019
1,296
154
-21.8
Usage of Energy
Astellas’ total energy consumption in FY2021
was 3,517 TJ, a year-on-year decrease of 0.2%
(8 TJ). Across regions, air conditioning
equipment uses a large volume of electricity,
and electricity accounts for a large proportion
of overall energy consumption. Going
forward, Astellas will continue to strive to
lower energy consumption by further
introducing electricity derived from
renewable energy sources and introducing
hybrid cars and electric vehicles, chiefly at
production sites in Japan.
Renewable energy
1,003 TJ
29%
Total
Energy consumption
3,517 TJ
in FY2021
Renewable sourced
98 GWh
43%
Total
Electricity consumption
226 GWh
in FY2021
Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Strategic Goal 4 Deepen our engagement in sustainability
Progress of Strategic Goal 4
Disclosure based on TCFD recommendations
An in-house cross-functional team for disclo-
sure based on TCFD recommendations was
established and the team conducted a
scenario analysis. The team analyzed Astellas’
business and climate-related risks and oppor-
tunities, on the assumption that transition
risks would materialize under a 2°C scenario
for climate change and physical risks would
materialize under a 4°C scenario*1. In FY2021,
the team undertook a qualitative scenario
analysis, and the content of the analysis was
discussed and raised at the EHS Committee.
*1 Reference was made to Working Group I Summary for Policymakers (SPM) of the Sixth Assessment Report published by the IPCC in
August 2021.
*2 Only some items were extracted from the analysis results. See the corporate website for details.
https://www.astellas.com/en/sustainability/TCFD-disclosure
Analysis of Risk and Opportunities*2
Climate Change Risks
Potential Financial Impacts
Astellas’ Resilience
Transition Risks (Risks that would materialize under a 2°C scenario)
Increased pricing of GHG
emissions (costs based on
premise of paying a
carbon tax).
Policy and
Legal
Business sites that have not introduced renewable energies may have to add
payment of a carbon tax to their costs.
Using renewable energies such as wind and solar power to generate electricity for some power used at business sites.
Switched to purchasing energy derived from renewable sources at business sites (Part of manufacturing and research sites and
sales offices in Europe and the United States. Some manufacturing and research sites in Japan started purchasing electricity
derived from hydroelectric power in FY2020.)
Promote the purchase of renewable energy-derived electricity at other business sites in the future.
Purchase credits (CO2 emission rights) to reduce Scope 1 emissions and measures to control costs associated with the purchase
will be issues for consideration.
Obsolescence and impair-
ment loss on existing
facilities accompanying
GHG emission regulations.
• Possibility of being asked to discard facilities due to strengthening of environmental
regulations
• Refrigeration equipment using freon gas.
• Vehicles that use fossil fuel may no longer be available in some countries after 2035.
There are no existing facilities that we are forced to dispose of. Regarding freon gas, we will take appropriate measures that
comply with laws and regulations.
From 2030 onwards we need to respond to a change of automobile (shift from internal combustion engines to electric motors and
fuel cells). Shift to EVs for sales fleets and trucks and modal shift of transportation will have an impact on the business operation.
Physical Risks (risk materializing at 4°C increase)
Acute
Increased severity of
extreme weather events
such as floods.
Operations halt at our business sites due to floods or other factors. Raw material
and product supply is delayed due to damage in the supply chain caused by floods
or other factors.
[Toyama Technology Center]: For flood risk assessment, we asked a consultant to create a hazard map and designed the
[Yaizu Facilities]: The Yaizu Facilities tsunami hazard map envisages damage being minor.
building based on the recommendations.
We are analyzing the supply chain for each business site. We are implementing measures such as inventory control with a
margin for continuous stable supply. Environmental risk assessment of supply chain is conducted by using an in-house system
called “Risk Assessment on Third Party Lifecycle Management”.
Climate-related Opportunities
Potential Financial Impacts
Astellas’ Response
• Use of more efficient produc-
Reduced operating costs
Resource
efficiency
tion and distribution processes
• Use of recycling
Together with other companies in the same industry we established and operate a joint logistics center in Hokkaido. This is conducive to making the logistics process more efficient.
Started operating the Kyushu Logistics Center in Fukuoka Prefecture. As the joint distribution center in Hokkaido achieved an efficient supply of pharmaceuticals and reduction of
CO2 emissions, the same outcome is expected for the Kyushu Logistics Center.
In European countries and the United States, warehouses shared by multiple pharmaceutical manufacturers are being used to streamline the distribution process.
We collect exhaust heat from air conditioning units at Japanese manufacturing plants and research sites and use it to pre-heat the air supply to improve heat efficiency.
• Development and/or expansion
Products and
market
of low emission goods
• New products and services
• Access to new markets
Increased revenues
through access to new and
emerging markets
For the spread of infectious diseases in endemic areas due to temperature change and the needs for new drugs for the treatment of infectious diseases as a result of antimicrobial
resistance, collaboration with the Phage Biologics Research Course at a university to create engineered bacteriophages, which could be an option for solving these issues.
Climate change can change the area of occurrence, morbidity, and severity of epidemic diseases. Heart disease, respiratory disease, etc., may also increase in prevalence.
56
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Strategic Goal 4 Deepen our engagement in sustainability
Progress of Strategic Goal 4
Initiatives for Resource Recycling and Pollution Prevention
Astellas believes that maintaining a healthy
global environment is an essential theme
for building a sustainable society, and it is
also an important element in ensuring the
continuation of business activities.
Our Environmental Action Plan sets
out short-term and medium-term targets
for our activities regarding the key points
of the Astellas Environment, Health &
Safety Guidelines. We renew our action
plans on a rolling basis, by reviewing
progress and conditions during the previous
year and incorporating our findings into our
Environment Action Plan for the following
year. The Plan has been consistently
managed well, and even higher targets
have been set from FY2021. We are contin-
uously implementing measures in line
with the target fiscal years set out in each
Plan. Results for FY2021 are as follows:
Environmental Action Plan for Preventing Pollution
Item
Goal
FY2021 Results
Measures for the Conservation of
Natural Resources
Enhance water resource productivity*1 by around 20% of the
FY2016 result by the end of FY2025
Ratio to base year 17%
improvement
External Evaluation Regarding ESG
Astellas has been selected as a constitu-
ent of numerous ESG investment indexes,
having received high ESG scores from
external rating agencies for its ESG initia-
tives. We continually take a closer look at
ESG Assessments
such scores and indexes to identify
opportunities for further improvement
and to pursue sustained efforts to
enhance our ESG activities.
2018
2019
2020
2021
FTSEESG Ratings
(0 to 5, higher scores are better)
ICB supersector: Health Care Percentile rank
(1 to 100, higher scores are better)
MSCI ESG Ratings
(Scale from CCC to AAA)
CDP Climate Change
(A to F, A is the highest)
3.3
67
AA
B
3.9
87
AA
B
-
3.6
81
AA
A-
-
4.0
94
AA
B
14th/20
Waste management
Improve waste generated per unit of revenue*2 by around
10% of the FY2016 result by the end of FY2025
Ratio to base year 1%
deterioration
Access to Medicine Index
(ranks the world’s 20 pharmaceutical companies)
19th/20
Biodiversity
Quadruple the biodiversity index by FY2025 from the
FY2005 level
Ratio to base year
3.8 times
Sustainalytics
(Scale from Negligible to Severe)
Medium
Medium
Medium
Medium
*1 Water resource productivity = Revenue (¥ billion)/Water resources withdrawn (1,000 m3) (For research and production sites in Japan
and overseas)
*2 Waste generated per unit of revenue = Volume of waste generated (tons)/Revenue (¥ billion) (For research and production sites in
Inclusion in ESG Investment Indexes
Japan and overseas)
Effective Use of Resources
The effective use of water resources serves as a
useful indicator for gauging society’s impact
on biodiversity. Astellas is promoting efforts to
reduce the waste landfill volume to as close to
zero as possible through the proactive
recycling and reuse of waste materials.
Resource Recycling
Item
Volume of water resource withdrawn (1,000 m3)
Waste generation volume (Tons)
FY2019
7,493
13,922
FY2020
7,564
14,352
FY2021
7,394
13,882
FTSE 4Good Index Series
FTSE Blossom Japan
Index
FTSE Blossom Japan
Sector Relative Index
MISI Japan ESG
Select Leaders Index
MSCI Japan Empowering
Women Index (WIN)
S&P/JPX Carbon
Efficient Index
FTSE Russell (the trading name of FTSE International Limited and Frank Russell Company) confirms that Astellas has been assessed according to the FTSE4 Blossom Japan Sector
Relative Index criteria, and has satisfied the requirements to become a constituent of the FTSE4 Blossom Japan Sector Relative Index. The FTSE4 Blossom Japan Sector Relative
Index is used by a wide variety of market participants to create and assess responsible investment funds and other products.
THE INCLUSION OF Astellas Pharma Inc. IN ANY MSCI INDEX, AND THE USE OF MSCI LOGOS, TRADEMARKS, SERVICE MARKS OR INDEX NAMES HEREIN, DO NOT CONSTITUTE A
SPONSORSHIP, ENDORSEMENT OR PROMOTION OF Astellas Pharma Inc. BY MSCI OR ANY OF ITS AFFILIATES. THE MSCI INDEXES ARE THE EXCLUSIVE PROPERTY OF MSCI. MSCI
AND THE MSCI INDEX NAMES AND LOGOS ARE TRADEMARKS OR SERVICE MARKS OF MSCI OR ITS AFFILIATES.
The 2-year progress report on Access to Medicine Index is as follows:
2018: https://accesstomedicinefoundation.org/media/uploads/downloads/5e27136ad13c9_Access_to_Medicine_Index_2018.pdf
2021: https://accesstomedicinefoundation.org/media/uploads/downloads/613f5fb390319_Access_to_Medicine_Index_2021.pdf
Copyright ©2021 Sustainalytics. All rights reserved. This [publication/ article/ section] contains information developed by Sustainalytics (www.sustainalytics.com). Such
information and data are proprietary of Sustainalytics and/or its third party suppliers (Third Party Data) and are provided for informational purposes only. They do not constitute
an endorsement of any product or project, nor an investment advice and are not warranted to be complete, timely, accurate or suitable for a particular purpose. Their use is
subject to conditions available at https://www.sustainalytics.com/legal-disclaimers.
57
Astellas Pharma Inc. Integrated Report 2022
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Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Organizational Health Goals
Organizational Health Goals (OHGs) have been estab-
lished to implement CSP2021 more effectively. They are
important for the reliable execution of CSP2021 and for
the personal growth of individual employees to foster a
corporate culture enabling the creation of greater inno-
vation to reach more ambitious goals.
We have promoted the understanding of CSP2021 by
increasing the opportunities and frequency of dialogue
between Top Management and employees and not just
cascading down through functional responsibility.
In addition, we have established the Astellas Leader-
ship Expectations and completed training to all Astellas
leaders (approximately 3,000) to dramatically transform
organizational culture.
We have also introduced “shared objectives” across
divisions/functions and “ambitious objectives” in order to
drive further collaboration and intelligent risk taking for
innovation. Other OHG-related initiatives are also in progress.
In order to increase our time and resources to focus
on critical work, advance necessary activities faster and
be more innovative, we started the "Dansharism"
initiative from FY2022.
Based on the idea that time is the most valuable
resource, by identifying and being “brave” to eliminate work
that lacks sufficient purpose reason, and identifiable
return on investment (ROI), we secure resources for our
priority core business and also drive further innovation.
Relationship to Material Issues
• Talent and organizational culture for realizing innovation
58
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Message from the Head of Human Resources
We will focus on building an
organization that continues
to grow so that we can
maximize our contribution
VALUE to patients.
Katsuyoshi Sugita
Executive Vice President,
Human Resources*
*1 Appointed as Chief People Officer and Chief Ethics & Compliance Officer (CPO & CECO) effective October 1, 2022.
People and organizational initiatives toward the Organizational Health
Goals (OHGs) directly link to contributions to the business.
intelligent risk-taking to embrace new challenges. Through these efforts under CSP2021, it will
surely lead business results.
While it is still too early to see major changes as we have only just finished the first year of
CSP2021, in the first year of the plan, we carried out a leadership training program called
“Ignite.” The program presented the detailed image of leadership style that Astellas expects of
its leaders. I feel that this has given our leaders a heightened awareness of their importance as
role models, and of the need to take ownership in fostering the development of our people
and organizational culture. Our leaders now have a better grasp of the importance of giving
their teams and organizations a high level of psychological safety. A total of 2,888 leaders
attended, for a participation rate of 99%. We worked to develop this as a company-wide system.
In addition, employees are increasingly interested in going beyond their own organizations
to explore opportunities for work or positions in other divisions. There have been some positive
changes, such as cases where employees planned their own careers and took up the challenge
of open positions. In such case, the Company openly select employees while matching their
wishes as much as possible. The basic rule for internal transfers is free competition based on
the wishes of each individual.
In addition, we have significantly increased the opportunities for direct communication
When I joined Astellas in 2021, what surprised me was that globalization is progressing in every
from top management*2. In the “Ask Me Anything” sessions, which are part of the measures to
aspect. Along with the globalization of our business, which is reflected in the increase in the
spread CSP2021 with employees, employees communicate directly with Top Management, who
ratio of overseas sales and the ratio of overseas employees, we have also globalized our HR
answer the employees’ questions directly in their own words. I see this as another unique
policies and organizations to support that change. For example, most companies tend to divide
Astellas initiative for employees to work together as One Astellas.
their human resources divisions into domestic and overseas divisions by setting up an interna-
tional human resources division. But at Astellas, our human resources division manages both
domestic and international operations under a single division. This gives us a unified chain of
command and a globally integrated human resources system. We put in place remote work from
an early stage, creating an environment for company-wide collaboration to contribute to
patients across countries.
The OHGs set forth in Corporate Strategic Plan 2021 (CSP2021) will work as “a bridge” that
*2 President and Chief Executive Officer, Chief Strategy Officer, Chief Administrative Office • Chief Ethics & Compliance Officer,
Chief Medical Officer, Chief Commercial Officer, Chief Scientific Officer, Chief Financial Officer, General Counsel, and Chief
Manufacturing Officer.
There is still more that our organization and
our employees can do to achieve CSP2021.
connects these people and organizational efforts to contributions to our business. In working
As I mentioned, our efforts to drive innovation are beginning to bear fruit. But there are still
toward our OHGs, we will promote cross-functional collaboration so that we can “excel as One
areas where we can improve. One example is the number of organizational hierarchies. In
Astellas.” We will nurture innovation by encouraging people and organizations who can take
general, the more hierarchies we have, the more approval processes we have and the slower
59
Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Message from the Head of Human Resources
the decision-making process becomes. This can hinder innovation in terms of time and cost.
Another important factor for continuing to be chosen by stakeholders is to be a purpose-driven
We are working to improve this by streamlining our organizational structure. The less hierarchy
organization. All our employees have a clear understanding of our purpose as an organization.
there is, the easier it is for people to propose and discuss ideas freely and frankly. Reducing
They know that we are working toward our OHGs and using human resources initiatives to
hierarchies is an important issue for approaching our target organization under the OHGs. The
build an organization that can drive innovation. They understand how we aim to channel
Dansharism initiative that we began this fiscal year also creates an environment that nurtures
those efforts toward business results, so that we can maximize the VALUE we deliver to
innovation. It does this by cutting out excess and inefficiencies and focusing resources on
patients. They can see how all of these initiatives align with the VISION.
what is truly necessary.
In order to continue to create more VALUE through innovation and to be an organization
Aside from organizational structure, another essential element of driving innovation is our
that continues to be chosen by stakeholders, we will focus on achieving CSP2021, which
employees’ mindset. We will continue to increase communication to further foster the mindset
includes OHGs. And I will always enjoy taking on new challenges.
of putting patients first and delivering Astellas VALUE.
To continue driving innovation, it is important not only to have mutually supportive
relationships, but also to actively pursue results. The key to this is psychological safety. When
we are willing to take intelligent risks and challenge ourselves to achieve results, there can be
a time for criticism or tough discussions. An organization with a high level of psychological
safety can talk about things frankly without having to avoid such hard discussions. That
enables the organization to put in the preparation needed to push itself to the next level. We
will continue to work on building our organization to have this kind of psychological safety.
We aim to build an organization that our
stakeholders will continue to choose.
One of my goals is for Astellas to be an organization where employees choose it because that
is where they want to work. Astellas should be a place where people can continue to grow on
their own with a growth mindset. A growth mindset means not placing limits on your qualities
and abilities. It is the idea that you can develop your own potential as much as you want with
your experience, effort, and attitude. I have always pursued my career with this idea. Based on
this mindset, each and every employee will continue to have a willingness to learn, and will
become highly motivated, capable, and able to choose their own careers. We aim to be an
organization that continues to be chosen by such talents for their sympathy with the VISION,
passion for their duties, job satisfaction, co-workers, and the good working environment.
60
Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
People and Organization for Innovation
To realize our VISION, the engagement of “talent” who are working in Astellas is essential.
Investment in our people is important for the future of Astellas, in addition to
enhancing our current ability for execution. We continue to invest with both short-term
and long-term perspectives. We want our employees to feel empowered to shape the
future of our organization. To that end, we are building a workplace where diverse
teams and individuals can thrive amid a culture of mutual learning and respect. We are
committed to creating an environment where all our employees can become peak
performers at their jobs and stay both physically and mentally healthy.
In 2016, Astellas has developed HR VISION based on Astellas Way to clarify our
desired people and organization. By optimizing 3 key areas: attraction, retention and
development, Astellas aims to be an “Employer of Choice”.
In addition, we newly established “Organizational Health Goals (OHGs)” in CSP2021
by identifying the elements necessary to achieve CSP2021. With our effort to achieve
OHGs, we nurture a corporate culture that aims at reaching ambitious goals by pro-
moting innovation, optimizing our talent, and fostering collaboration, which enhanc-
es Astellas’ ability for execution.
Overview of the HR VISION
Towards Realizing the Corporate VISION
One Astellas with the Astellas Way
Our People
Our Organization
Embrace Change and Challenge
Value Diversity and Inclusion
Serve Others
Act with Integrity
Resilient
Inspired
Aligned
Ethical
HR MANAGEMENT
DEVELOP
EMPLOYER
OF
CHOICE
ATTRACT
RETAIN
The Astellas Way
–5 Messages for One Astellas–
VISION
Patient Focus:
Ask yourself if your decisions and actions contribute to
improving patient health.
Ownership:
Embrace change and always challenge by
taking ownership.
Results:
Commit to results each time you face a challenge, and
consider fresh approaches to achieving them.
Openness:
Maximize your creativity through diversity and open
communication.
Integrity:
Act With integrity by always considering the implications
of your actions, and then responsibility for the outcomes.
61
Establishment of HR system
corresponding to our global
functional organization
P.62
Setting of Organizational Health
Goals to transform into
more Innovative
Organization
OHGs
P.63
Creating an environment in which diverse talent can thrive
EDE&I
P.65
Establishment of
Astellas
CSP2021
2005
2021
Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Initiatives for People and Organization
Establishment of HR system corresponding to our global functional organization
Flattened the hierarchy
In line with the globalization of our business, we are transitioning to a global organization
divided by function, and are promoting the integration and harmonization of personnel
systems so that we can deploy the right people in the right place on a global scale. These HR
measures support Astellas’ business and strengthen its competitiveness in recruiting talent.
Key Activities
Details
Achievements in FY2021
Harmonization of grade
structure and job evalua-
tion
Succession planning
Consistency in grades based on
each position's responsibilities
regardless of where they work or
which division they belong to
Job evaluations by globally com-
mon methodology and processes
Develop, discuss and implement
Talent Review and Succession Plan
Enhancing and Developing the
Talent Pipeline
Completed for managers and above
Implemented for all VPs and above
Prepared succession plan for all VPs
and above. Expanding to other key
positions
Identify multiple candidates from
the talent pool of the entire Astellas
and execute a development plan
Harmonizationof compen-
sation structures and levels
For all VPs and above worldwide
• Completed a globally common compensation structure
• Promote level integration between regions
Job posting system
Implementation of global job
posting system (many positions
around the world can be posted)
Completed approx. 300 internal
hirings
Total of more than 2,000 applications
HR Database
Details
HR CONNECT
Establishment of a database that serves as a foundation of talent
management by visualizing all talent data worldwide
Operation and execution of talent management including the programs
above within a globally integrated HR system
Led by the CEO, Astellas is promoting measures to become an innovative organi-
zation that does not become political even with a large number of people.
By referring to the magic number*1 equation introduced in LOONSHOTS*2
by Safi Bahcall, which describes innovation in organizations, and by increasing this
magic number, we aim to transform the organization into an organization that is
more likely to generate innovation. Among the indicators that affect the magic
number, we are focusing on the equity ratio, management span, and organiza-
tional fitness level, and are working on reshaping the HR system.
M ≈
ES2F
G
E: equity ratio
S: management
span
F: organizational
fitness level
G: salary increase
ratio
*1 The critical size of an organization, considered in terms of incentives such as salary and equity (giving employees some form of a
share of successful projects). At scale below this threshold, all employees struggle to produce LOONSHOTS, but at scale the
balance shifts from project-focused to political-focused.
*2 LOONSHOTS: How to Nurture the Crazy Ideas That Win Wars, Cure Diseases, and Transform Industries by Safi Bahcall, published in
2019, published by St. Martin’s Press.
As for equity ratio, we changed the calculation method for bonuses to be based on company-wide
indicators. As a result, "VALUE" that Astellas creates will be more directly linked to the rewards for
individuals, and the balance will shift to an organization that focuses on innovation and results rather
than politics.
At Astellas, management span is viewed as span of control, which represents the number
of direct reports to each leader.. By increasing this management span, we aim to make our
organization flatter and to make it maximum of 6 layers to speed up decision-making. In addition,
we need leaders who can appropriately pick up innovative ideas that would arise in the flatter
organization and can support the growth of their subordinates at the same time. We have
clarified the leadership image that Astellas is aiming for under the OHG and promoting the
development of leaders through leadership training.
At Astellas, organizational fitness level refers to the right person in the right place, including
timing, not seniority. In order to find the best talent for a certain position from all over the world,
we have built a global HR system so that we can search for the right talent globally. In addition,
we have established and operate a global job posting system that allows employees from all over
the world to apply for desired posts.
We believe that both reforming the organization structure and working to foster a culture of
taking on challenges without fear of failure, it will accelerate the development of innovative
medical solutions and lead to the realization of VISION.
62
Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Organizational Health Goals
We newly established “Organizational Health Goals (OHGs)” in CSP2021. The purpose of these goals is to nurture a corporate culture that aims at reaching ambitious goals by
promoting innovation, optimizing our talent, and fostering collaboration, which enhances Astellas’ ability for execution.
To identify the factors that block our innovation, interviews were conducted to collect employees’ and leaders' opinions. Furthermore, we analyzed the collected comments of
employees and set OHG1-3.
We are promoting initiatives to achieve each goal.
Planning process
Initiatives to achieve Organizational Health Goals
Identified Issues
Organizational Health Goals
Initiatives & Progress
Interviewing
employees and
leaders around
the world and
collect their
opinions
• Extensive fear of failure and
unwillingness to take business
risks to achieve innovation
• Conservative objective setting
• Reluctance to update and develop
new systems and processes to
meet new challenges
I
d
e
n
t
i
f
y
t
h
e
f
a
c
t
o
r
s
• Unclear image of leadership to
generate innovative ideas
• Lack of development plans to
foster leadership
• Evaluation system that promotes
departmental optimization
• Silo situation and lack of trust
between divisions
1.
“Brave ideas pursue
ambitious outcomes”
Aggressively take on challenges
for innovation and
ambitious outcomes
Launch of psychological safety playbook
Implementation of ambitious objective setting for all individual
employees, as well as for divisional objectives for FY2022
Introduction of Dansharism
Launch of white space* toolkit for managers
2.
“Talent and
leadership thrives”
Environment in which excellent
people have ownership and
demonstrate leadership
3.
“We excel as
One Astellas”
Collaborate across divisions to
achieve shared goals for
all Astellas
Establishment and launch of the Astellas Leadership Expectations
Completion of leadership training to all Astellas leaders
Introduction of global feedback initiative
Execution of multiple talent development initiatives
Implementation of shared objectives process
Removal of focus on divisional performance and replacement
with All Astellas Performance for Rewards
Promotion of direct dialogue and Q&A sessions with
Top Management
First ever global online Top Management live stream to all
Astellas employees
63
resources to be innovative.
* White space is defined as “having the time, tools, and expertise to think of new ideas.” It is having the necessary
Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Organizational Health Goals
Specific initiatives to achieve Organizational Health Goals
Organizational Health Goal 1
Brave ideas pursue ambitious outcomes
In order to achieve OHG1, to embed psychological safety in our organizational
culture is critical. We created and launched a psychological safety playbook
with actual use cases in several divisions. Both divisions and individual employ-
ees set ambitious objectives from FY2022 to achieve higher goals and training
was provided for that globally. The Dansharism* initiative was introduced in
FY2022 given the fact that a redesigned employee engagement survey revealed
a need for white space. The white space toolkit was also launched for managers
in response to that results to create better environment to pursue OHG1.
* Dansharism stands for our strong belief and mindset to be "brave" in eliminating work that lacks sufficient purpose, reason,
and identifiable return on investment (ROI) (excl. things that are necessary for legal regulations).
Organizational Health Goal 2
Talent and leadership thrives
We have newly set 12 Astellas Leadership Expectations with a specific
focus on empowering ownership, delegating decision making to the right
level and providing frequent feedback, then completed the so-called
“IGNITE” leadership training for alll Astellas leaders (approx. 3,000 people).
Through IGNITE and also newly initiated Astellas leader forums we are
working on activating continuous feedback. This ultimately leads leads to
an innovative and high-per formance culture.
We are also actively engaging in multiple talent development initiatives
including a female talent development program and enhanced succession
planning and talent review process from FY2022.
Organizational Health Goal 3
We excel as One Astellas
A shared objectives process introduced during FY2022 annual planning which pro-
moted dialogue and collaboration between divisions on initiatives in support of
CSP2021. Up to 100 shared objectives identified, along with key contributors and
success measures. For FY2022, STI (short-term incentive) and LTI (long-term incentive)
Rewards for employees: we removed division performance measures and replaced them
with All Astellas Performance to incentivize greater collaboration and non-siloed work.
We undertook measures to disseminate CSP2021 and OHG throughout the
organization and increased direct dialogue and Q&A opportunities with Top
Management such as “Ask Me Anything” sessions. Also, the first ever global
online Top Management live stream to all Astellas employees was held in May
2022 including the entire Top Management team focused on role modeling
and collaboration.
64
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Engagement, Diversity, Equity and Inclusion
Astellas is working to promote diversity so that diverse individuals can play a role
in the Company, irrespective of their identity. Respecting the diverse values of our
employees and reflecting their various perspectives in our business activities not
only heightens creativity in our organization, but also helps to attract and retain
talented people as employees and enhances our competitiveness. Based on our
global Engagement, Diversity, Equity and Inclusion philosophy, Astellas integrates
diversity, equity and inclusion into each region.
Engagement
When people are treated with respect and valued for who they are and what talent they bring, they speak up and share
brave ideas in unimaginable ways.
Diversity
When organizations have diversity in their people, leaders and suppliers, they more fully represent the patients' community,
are better positioned to understand and address patients' unmet needs and create sustainability in all its forms.
Equity
When people are seen and treated as the individuals they are, barriers are eliminated, and their unique needs are met,
they can enjoy optimal health and the fullness of the value they bring is unleashed.
Inclusion
When we foster inclusive environments that create psychological safety, a sense of belonging, and empowerment,
there is high-quality and efficient collaboration, problem-solving, decision-making, innovation and ultimately,
VALUE creation.
VOICE
As we continue to foster organizational health and aspire towards our CSP2021, it is evident that
diversity (in all forms) drives innovation; inclusion enables psychological safety, thoughtful risk-taking,
and equitable experiences; and engaged employees are more productive. We know that all of these
things foster a culture of ethics and integrity which is at the
core of what we do and who we are at Astellas. Furthermore,
with each passing day we witness just how interdependent
we all are and how Engagement, Diversity, Equity and
Inclusion (EDE&I) are mutually beneficial to each of us
and our collective sustainability.
La Toya McClellan
The Head of Engagement,
Diversity & Inclusion
65
Composition ratio of employees by region
(As of July 2022)
8%
10%
34%
24%
24%
■ JAPAN
■ United States
■ Established Markets*1
■ International Markets*2
■ Greater China*3
Foreign nationality ratio of Division Heads
(As of July 2022)
51%
49%
■ Foreign nationality
■ Japanese nationality
Percentage of female managers (As of July 2022)
Mid-career hiring rate (Japan) (As of July 2022)
13%
44%
57%
43%
Outside: Global
Inside: Japan
■ Female managers
■ Mid-career hiring
■ New graduates hiring
*1 Established markets: Europe, Canada, Australia
*2 International Markets: Russia, Latin America, Middle East, Africa, Southeast Asia, South Asia, Korea, Export sales, etc.
*3 Greater China: China, Hong Kong, Taiwan
Promoting Health Management
Putting into practice work styles that allow every employee to demonstrate high productivity and creativity and realize
their own potential will energize us as an organization and lead to corporate growth as One Astellas. The realization of
such work styles is predicated on employee health and the creation of a sound corporate culture.
A sound corporate culture requires a psychologically safe environment in which all employees respect each other and
can actively communicate with peace of mind. Astellas is committed to pursuing organizational health through the
support of diverse work styles and the promotion of employee health, ensuring all employees enjoy physical and mental
wellbeing, thus enabling them to strive for even greater productivity.
Health Management Promotion System
Astellas’ health management promotion system in Japan is planned and operated mainly by the
Human Resources (including health staff ), Astellas Health Insurance Society and labor union, and
headed by the Chief Administrative Officer and Chief Ethics & Compliance Officer (CAO & CECO). In
addition, these 3 parties collaborate to consider and advance measures for employee health issues in
periodic health management meetings.
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Strengthening Governance
CONTENTS
Strengthening Governance
Board of Directors
Corporate Governance
Interview with an Outside Director
Risk Management
Ethics & Compliance
66
67
69
76
78
80
66
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Board of Directors
(As of June 20, 2022)
Kenji Yasukawa
Representative Director, President and
CEO, Chairman of the Board
Naoki Okamura
Representative Director,
Executive Vice President
Mamoru Sekiyama
Outside Director
Hiroshi Kawabe
Outside Director
Takashi Tanaka
Outside Director
Eriko Sakurai
Outside Director
Rate of attendance in meetings of the Board of
Directors: 100% (13/13 times)
Number of shares of the Company owned:
78,715 shares
Rate of attendance in meetings of the Board of
Directors: 100% (13/13 times)
Number of shares of the Company owned:
11,000 shares
Rate of attendance in meetings of the Board of
Directors: 100% (13/13 times)
Number of shares of the Company owned:
0 shares
Rate of attendance in meetings of the Board of
Directors: 100% (13/13 times)
Number of shares of the Company owned:
0 shares
Rate of attendance in meetings of the Board of
Directors: 90% (9/10 times)
Number of shares of the Company owned:
0 shares
Number of shares of the Company owned:
0 shares
Resume, position and responsibilities
at the Company
Resume, position and responsibilities
at the Company
Resume, position and responsibilities
at the Company
Resume, position and responsibilities
at the Company
Resume, position and responsibilities
at the Company
Resume, position and responsibilities
at the Company
Joined the Company
April 1986:
April 2005: Vice President, Project Management,
Urology, the Company
June 2010: Corporate Executive of the Company
and Therapeutic Area Head, Urology,
Astellas Pharma Europe B.V.
Corporate Executive of the Company
and Therapeutic Area Head, Urology,
Astellas Pharma Global Development,
Inc.
October
2010:
April 2011: Corporate Executive, Vice President,
Product & Portfolio Strategy, the
Company
April 2012: Corporate Executive, Chief Strategy
Officer (CSTO), the Company
June 2012: Senior Corporate Executive, Chief
Strategy Officer (CSTO), the Company
April 2017: Senior Corporate Executive, Chief
Strategy Officer and Chief Commercial
Officer (CSTO & CCO), the Company
June 2017: Representative Director, Executive Vice
President, the Company
April 2018: Representative Director, President and
CEO, the Company (present post)
April 1986:
October
2010:
April 2012:
July 2014:
April 2016:
Joined the Company
President & CEO, OSI Pharmaceuticals,
Inc.
Senior Vice President, Chief Strategy
Officer, Astellas Pharma Europe Ltd.
Vice President, Licensing & Alliances,
the Company
Vice President, Corporate Planning,
the Company
June 2016: Corporate Executive, Vice President,
Corporate Planning, the Company
April 2018: Corporate Executive, Chief Strategy
Officer (CSTO), the Company
April 2019: Corporate Executive Vice President,
June 2019:
October
2019:
September
2021:
March
2022:
April 2022:
Chief Strategy Officer (CStO), the
Company
Representative Director, Executive Vice
President, Chief Strategy Officer
(CStO), the Company
Representative Director, Executive Vice
President, Chief Strategy Officer and
Chief Financial Officer (CStO & CFO),
the Company
Representative Director, Executive Vice
President, Chief Strategy Officer, Chief
Financial Officer and Chief Business
Officer (CStO & CFO, and CBO), the
Company
Representative Director, Executive Vice
President, Chief Strategy Officer and
Chief Business Officer (CStO and CBO),
the Company
Representative Director, Executive Vice
President and Chief Strategy Officer
(CStO), the Company (present post)
April 1974:
April 1997: General Manager, Power Project
Joined Marubeni Corporation
Dept.-I, Marubeni Corporation
April 1998: General Manager, Power Project
Dept.-III, Marubeni Corporation
April 1999: Deputy General Manager, Power
April 2001:
Project Div.; General Manager, Power
Project Dept. -I, Marubeni Corporation
Senior Operating Officer, Utility
Infrastructure Div.; General Manager,
Overseas Power Project Dept.,
Marubeni Corporation
April 2002: Corporate Vice President, Chief
Operating Officer, Plant, Power &
Infrastructure Div., Marubeni
Corporation
April 2005: Corporate Senior Vice President, Chief
Operating Officer, Plant, Power &
Infrastructure Projects Div., Marubeni
Corporation
June 2006: Corporate Senior Vice President,
Member of the Board, Marubeni
Corporation
April 2007: Corporate Executive Vice President,
April 2009:
Member of the Board, Marubeni
Corporation
Senior Executive Vice President,
Member of the Board, Marubeni
Corporation
Vice Chairman, Marubeni Corporation
April 2013:
April 2015: Corporate Adviser, Marubeni
Corporation; Chairman, Marubeni
Power Systems Corporation
June 2017: Director, the Company (present post)
April 2020: Outside Director and Audit &
Supervisory Committee Member,
A.D. Works Group Co., Ltd. (present post)
67
May 1979:
Assistant, Department of Internal
Medicine, Keio University School of
Medicine
April 1990: Assistant Professor, Health Center, Keio
April 1981:
April 2003:
University
Joined Kokusai Denshin Denwa Co.,
Ltd. (KDD)
Executive Officer, General Manager,
Solution Product Development
Division, Solution Business Sector,
KDDI CORPORATION
April 2002:
April 1991: Assistant Professor, Department of
Internal Medicine, Keio University
School of Medicine
April 1996: Associate Professor, Health Center,
Keio University; Associate Professor,
Department of Internal Medicine, Keio
University School of Medicine
Professor, Health Center, Keio
University; Professor, Department of
Internal Medicine, Keio University
School of Medicine
Vice President, Health Center, Keio
University
President, Health Center, Keio
University
Trustee, Japan University Health
Association
Trustee, Daiwa Securities Health
Foundation (present post)
President, Foundation for Promotion
of Medical Training (present post)
Professor Emeritus, Keio University
(present post)
October
2003:
October
2011:
June 2013:
March
2017:
March
2018:
April 2018:
June 2007: Managing Executive Officer, Executive
August
2007:
Director, Solution Business Sector,
KDDI CORPORATION
President, Wireless Broadband
Planning Inc. (current UQ
Communications Inc.)
April 2009: Managing Executive Officer, Solution
Business Sector, KDDI CORPORATION
April 2010: Managing Executive Officer, Solution
Business Sector, Consumer Business
Sector, and Product Development
Sector, KDDI CORPORATION
Senior Managing Executive Officer,
Solution Business Sector, Consumer
Business Sector, and Product
Development Sector, KDDI
CORPORATION; Chairman, UQ
Communications Inc.
Representative Director, President,
KDDI CORPORATION
Representative Director, Chairman of
the Board, KDDI CORPORATION
(present post)
December
2010:
April 2018:
June 2010:
June 2019: Director, the Company (present post)
June 2018: Director, Okinawa Cellular Telephone
Company (present post)
June 2021: Director, the Company (present post)
June 1987:
March
2009:
Joined Dow Corning Corporation
(current Dow Silicones Corporation)
Chairman and CEO, Representative
Director, Dow Corning Toray Co., Ltd.
(current Dow Toray Co., Ltd.)
Regional President Japan/Korea, Dow
Corning Corporation (current Dow
Silicones Corporation)
June 2014: Outside Director, Sony Corporation
May 2011:
February
2015:
(current Sony Group Corporation)
President, Representative Director,
Dow Silicones Holdings Japan
Kabushiki Kaisha (current Specialty
Products Japan Godo Kaisha)
August
2020:
June 2015: Outside Director, Sumitomo Mitsui
Financial Group, Inc. (present post)
President and Representative Director,
Dow Chemical Japan Limited;
President, Representative Director,
Dow Japan Holdings Kabushiki Kaisha
(current Dow Chemical Japan
Limited); President, Representative
Director, Performance Materials Japan
Kabushiki Kaisha
Outside Director, Kao Corporation
(present post)
March
2022:
June 2022: Director, the Company (present post)
Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Board of Directors
Toru Yoshimitsu
Director, Audit & Supervisory Committee Member
Haruko Shibumura
Outside Director, Audit & Supervisory Committee Member
Raita Takahashi
Outside Director, Audit & Supervisory Committee Member
Mika Nakayama
Outside Director, Audit & Supervisory Committee Member
Rate of attendance in meetings of the Board of Directors: 100% (13/13 times)
Rate of attendance in meetings of the Audit & Supervisory Committee:
100% (14/14 times)
Number of shares of the Company owned: 47,818 shares
Rate of attendance in meetings of the Board of Directors: 100% (13/13 times)
Rate of attendance in meetings of the Audit & Supervisory Committee:
100% (14/14 times)
Number of shares of the Company owned: 0 shares
Rate of attendance in meetings of the Board of Directors: 100% (13/13 times)
Rate of attendance in meetings of the Audit & Supervisory Committee:
100% (14/14 times)
Number of shares of the Company owned: 0 shares
Number of shares of the Company owned: 0 shares
Resume, position and responsibilities at the Company
Resume, position and responsibilities at the Company
Resume, position and responsibilities at the Company
Resume, position and responsibilities at the Company
August 1984:
April 2015:
April 2017:
June 2020:
June 2022:
Joined Nippon Synthetic Rubber Co., Ltd.
(current JSR Corporation)
Officer, General Manager of Corporate Planning Department
and General Manager of Diversity Promotion Office,
JSR Corporation
Executive Officer, General Manager of Intellectual Property
Department, JSR Corporation
Director, Senior Officer, General Manager of Sustainability
Promotion Dept., JSR Corporation
Director, the Company (present post)
April 1987:
April 2013:
June 2015:
April 2017:
April 2019:
October 2019:
April 2020:
June 2020:
Joined the Company
Senior Vice President, Product & Portfolio Strategy, the
Company
Corporate Executive, Senior Vice President, Product &
Portfolio Strategy, the Company
Corporate Executive, Senior Vice President, Corporate
Finance & Control, the Company
Corporate Executive, Senior Vice President, Corporate
Financial Planning & Analysis, the Company
Corporate Executive, Senior Vice President, Finance and
Corporate Financial Planning & Analysis, the Company
Report to CEO, the Company
Director (Audit & Supervisory Committee Member), the
Company (present post)
April 1987:
August 1987:
April 1994:
April 1999:
October 2006:
June 2015:
April 2016:
June 2018:
June 2019:
Joined Chiyoda Mutual Life Insurance Company
Joined Kyushu University Press
Registered as an attorney-at-law (Dai-ni Tokyo Bar
Association); Joined Law Offices of Honma & Komatsu
(current Homma & Partners)
Partner Lawyer, Homma & Partners (present post)
Committee member, Compliance Committee,
TAMURA Corporation
Outside Audit & Supervisory Board Member, NICHIREKI
CO., LTD.
Committee member, Compliance Special Committee,
TAMURA Corporation
Outside Director, TAMURA Corporation (present post)
Director (Audit & Supervisory Committee Member), the
Company (present post); Outside Director, NICHIREKI CO.,
LTD. (present post)
Skill Matrix and Composition of Advisory Committees
October 1986:
Joined Sanwa · Tohmatsu Aoki Audit Corporation
(current Deloitte Touche Tohmatsu LLC)
Joined Chuo Audit Corporation
Established TAKAHASHI Accounting & Tax office (present post)
Representative Partner, ChuoAoyama PricewaterhouseCoopers
August 1995:
May 1997:
April 1999:
December 2000: Outside Audit & Supervisory Board Member, Alpha Group
March 2001:
June 2011:
January 2018:
June 2020:
Inc. (present post)
Representative Director, Yoshida Management Co. Ltd.
(present post)
Trustee, Japan Association of Healthcare Management
Consultants (present post)
Section President, Japanese Institute of Certified Public
Accountants, Minami-Kyushu Chapter, Kagoshima
Subcommittee
Director (Audit & Supervisory Committee Member), the
Company (present post)
Name
Outside
director
Company Management
Global
Business
Science &
Technology
Legal·Risk
Management
Finance ·
Accounting
Academia
Nomination Committee
Compensation Committee
Advisory Bodies
Director
Director
Audit & Supervisory
Committee Member
Kenji Yasukawa
Naoki Okamura
Mamoru Sekiyama
Hiroshi Kawabe
Takashi Tanaka
Eriko Sakurai
Toru Yoshimitsu
Haruko Shibumura
Raita Takahashi
Mika Nakayama
(Trading)
(Telecommunication)
(Chemicals)
(Chemicals)
—
—
Chair
—
—
Chair
(Medicine) Member of the Committee Member of the Committee
Member of the Committee Member of the Committee
Member of the Committee Member of the Committee
—
—
—
—
—
—
—
—
(Lawyer)
(Accountant)
68
Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Corporate Governance
Basic view
The Company’s raison d’être is to contribute to improving the health of people around
the world through the provision of innovative and reliable pharmaceutical products.
The Company aims to sustainably enhance enterprise value by being chosen and trusted
by all stakeholders. With this business philosophy, we work to ensure and strengthen the
effectiveness of corporate governance from the following perspectives:
1. Ensuring transparency, appropriateness and agility of management; and
2. Fulfillment of our fiduciary duties and accountability to shareholders and appropriate
collaboration with all stakeholders.
The summary of the corporate governance systems is as follows:
• The Company adopts the organizational structure of “Company with Audit & Supervisory Committee.” Outside Directors constitute the majority of the Board of Directors and the Audit
& Supervisory Committee, respectively.
• The Board of Directors determines basic policies of management, business strategies and other matters, and serves the oversight function of business execution.
• As an organ for handling execution of business, the Company establishes the Executive Committee for discussing important matters, and also appoints Top Management (the
President and Chief Executive Officer; the Chief Strategy Officer; the Chief Administrative Officer and Chief Ethics & Compliance Officer; the Chief Medical Officer; the Chief Commercial
Officer; the Chief Scientific Officer; the Chief Financial Officer; the General Counsel; and the Chief Manufacturing Officer are collectively referred to as “Top Management”), who are
responsible for the execution of business. The responsibility and authority for the execution of business by the Executive Committee and Top Management are clearly stipulated in the
"Corporate Decision Authority Policy".
• As advisory bodies to the Board of Directors, the Company establishes the Nomination Committee and the Compensation Committee, each of which are composed of a majority of
Outside Directors.
(1) Board of Directors
Ratio of females
30%
Governance systems
Election / Dismissal
Election / Dismissal
Election / Dismissal
General Shareholders’ Meeting
Internal director
(3 males)
Outside Director
(4 males and 3 females)
Term
Directors who are not Audit & Supervisory Committee Members and Directors who are Audit &
Supervisory Committee Members shall be 1 year and 2 years, respectively
Audit andsupervision
Number of meetings At least once every 3 months and additionally as necessary
(
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2
Audit & Supervisory Committee
Audit & Supervisory
Committee Office
Report
Direction
Audit
1
Board of Directors
3
Nomination Committee
Compensation Committee
Proposal / Reoprt
Appointment / Removal, Supervision
Report
Direction
I
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t
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r
n
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l
A
u
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i
t
Internal
Audit
President and CEO
CAO & CECO
CScO
CMfgO
CStO
CCO
GC
Top Management
CMO
CFO
Executive Committee
Proposal / Report
Direction / Supervision
Divisions
Execution
69
Summary
• The Board of Directors ensures the transparency and appropriateness of management by making
decision of corporate management policies and corporate strategies, etc., serving the oversight
function of the execution of business.
• The Board of Directors ensures the agility of management by delegating a substantial part of
decision-making authority of important business execution to an executive Director by resolution
of the Board of Directors and establishing “Corporate Decision Authority Policy” to clarify the
responsibility and authority for the execution of business by Top Management and others.
• The Board of Directors, in consideration of diversity and balance from the perspectives of
expertise and experience and so forth, is composed of a number of Directors appropriate to
facilitate agility.
• In order to ensure decision-making from a broader viewpoint and objective oversight of the
execution of business, the Board of Directors is composed of a majority of outside Directors.
• We elect at least one outside Director who possesses corporate management experience at
another company.
• Corporate Strategy: Quarterly business updates, establishment and disclosure of Corporate
Strategic Plan 2021, portfolio strategy, annual plan
• Risk Management: Report on enterprise risk management status, compliance update
• Stakeholder Engagement: Report on dialogue with investment community, sustainability
activity reporting and planning
• Corporate Governance: Board of Directors effectiveness analysis results (
please see next page
Main Agenda Items
of the Board of
Directors in FY2021
for details about evaluation of effectiveness of the Board of Directors),
Directors & officers personnel change / compensation, succession
planning (
for details, please see Organizational Health Goal on P.63)
Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Corporate Governance
Evaluation of effectiveness of the Board of Directors
Position
Name
Reasons for appointment
As a means of considering issues and making improvements to further enhance such role of
the Board of Directors, the Company conducts an analysis and evaluation of the effectiveness
of the Board of Directors every year, and a summary of the result of the analysis and evalua-
tion is disclosed below.
(1) The Chairman of the Board of Directors
conducted a survey based on question-
naires to Directors
(2) Based on the results of this survey, the
Board of Directors performed its analysis
and evaluation.
(4) Trying to understand the expectations and opinions of various stakeholders
and then reflecting them in discussions at Board of Directors meetings.
(3) Evaluation of effectiveness in FY2021
It was determined that the overall effectiveness of the Board of Directors is sufficiently ensured.
< Reasons for
the evaluation>
As a result of the survey on effectiveness, we have obtained a high evaluation as a whole, and
confirmed that there are the following activities and discussions behind it.
• The Board of Directors formulates strategy and business plans based on the business philosophy,
and has discussions and makes decisions while always taking into consideration strategic direction.
• The Board of Directors appropriately receives reports, has discussions and carries out supervision
regarding issues and the progress of business plans.
• The Board of Directors effectively utilizes the Nomination Committee, and appropriately supervises
succession planning and appropriately makes decisions regarding nomination.
• The Board of Directors effectively utilizes the Compensation Committee, and appropriately
establishes the remuneration system and decides the amount of remuneration.
Outside Director
Takashi Tanaka
Outside Director
Eriko Sakurai
Outside Director,
Audit & Supervisory
Committee Member
Haruko
Shibumura
Reasons for appointment of outside directors
Position
Name
Reasons for appointment
Outside Director,
Audit & Supervisory
Committee Member
Raita
Takahashi
Outside Director
Mamoru
Sekiyama
Outside Director
Hiroshi
Kawabe
He has been engaged in corporate management as a business manager of a general
trading company for many years, and has abundant global experience and extensive
insight. Since June 2017, he has been playing a key role as outside Director in the
management of the Company from an independent standpoint. In addition, as the Chair of
the Nomination Committee and the Compensation Committee, he has led the delibera-
tions of each Committee. The Company expects him to leverage his abundant global
experience and extensive insight to the management of the Company in the future as well,
and therefore requests his election as outside Director.
He has been engaged in medical treatment for many years while successively holding
important posts at Keio University as a medical scientist, and has abundant specialized
knowledge and experience in medical treatment. Since June 2019, he has been playing a
key role as outside Director in the management of the Company from an independent
standpoint. In addition, as a member of the Nomination Committee and the Compensation
Committee, he has contributed to the deliberations of each Committee by vigorously
expressing opinions. The Company expects him to leverage his abundant specialized
knowledge and experience to the management of the Company in the future as well, and
therefore requests his election as outside Director.
70
Outside Director,
Audit & Supervisory
Committee Member
Mika
Nakayama
He has been engaged in corporate management as a business manager of telecommuni-
cations companies for many years, and has abundant experience and extensive insight as
a business manager. Since June 2021, he has been playing a key role as outside Director
in the management of the Company from an independent standpoint. In addition, as a
member of the Nomination Committee and the Compensation Committee, he has
contributed to the deliberations of each Committee by vigorously expressing opinions.
The Company expects him to leverage his broad knowledge in the telecommunications
field and abundant experience and extensive insight as a corporate manager to the
management of the Company from an independent standpoint in the future as well, and
therefore requests his election as outside Director.
She has served in important positions for many years at a chemical manufacturer that
develops business globally and has its head office in the United States, and has been
engaged in corporate management at a Japanese subsidiary in the corporate group of
that company. She possesses abundant international experience and extensive insight.
The Company expects her to leverage her abundant international experience and
extensive insight for the management of the Company from an independent standpoint,
and therefore requests her election as outside Director.
She has been engaged in corporate legal affairs as an attorney-at-law, and has abundant
specialized knowledge and experience gained while serving in positions such as
professor at the Legal Training and Research Institute. The Company expects her to
leverage her abundant specialized knowledge and experience to supervise and audit the
Company’s management from the standpoint of Director who is an Audit & Supervisory
Committee Member in order to enhance the Company’s enterprise value, and therefore
requests her election as Director who is an Audit & Supervisory Committee Member.
With his many years of experience as a certified public accountant, he has thorough
knowledge of corporate consulting and auditing, and is also engaged in corporate
management as a business manager of a consulting company relating to business
accounting and tax accounting services, and has abundant specialized knowledge and
experience. Since June 2020, he has been playing a key role as outside Director who is an
Audit & Supervisory Committee Member in the supervision and auditing of the
Company’s management from an independent standpoint. The Company expects him to
leverage his abundant specialized knowledge and experience to supervise and audit the
Company’s management in the future as well. Therefore, the Company requests his
election as outside Director who is an Audit & Supervisory Committee Member.
She has abundant experience in the field of intellectual property at a globally operating
chemical manufacturer and, in addition to having served in important positions, has
been engaged in corporate management in the company. She possesses abundant
specialized knowledge and extensive insight. The Company expects her to leverage her
abundant specialized knowledge and extensive insight to supervise and audit the
Company’s management, and therefore requests her election as outside Director who is
an Audit & Supervisory Committee Member.
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
(2) Audit & Supervisory Committee
Amounts of remunerations
Internal director
(1 male)
Outside director
(1 male and 2 females)
Ratio of females
50%
Term
Supervisory Committee Members shall be 2 years
Number of meetings At least once every 3 months and additionally as necessary
• Audit & Supervisory Board Committee assumes a part of corporate supervisory function, and
contributes to the establishment of effective corporate governance systems by auditing the
performance of duties by Directors, as an independent organization entrusted by shareholders.
• The Audit & Supervisory Committee is the only deliberation body and decision-making body for
the purpose of forming opinions with regard to audits by Audit & Supervisory Committee
Members, and, where necessary, provides its opinions to Directors or the Board of Directors.
Summary
• The Audit & Supervisory Committee is composed of all the Directors who are Audit &
Supervisory Committee Members, and its chairman is determined by resolution of the Audit &
Supervisory Committee.
• In order to further enhance the independence and neutrality of the Company’s audit system,
the Audit & Supervisory Committee is composed of a majority of outside Directors.
• The Company appoints as Audit & Supervisory Committee Members individuals who have
appropriate experience and skills, as well as necessary knowledge of finance, accounting and
legal affairs.
(3) Nomination Committee and Compensation Committee
Nomination Committee
Ratio of females
Outside director
(3 males and 1 female)
Compensation Committee
Outside director
(3 males and 1 female)
25%
25%
Ratio of females
The Nomination Committee deliberates matters
relating to the election and dismissal of
Directors and appointment and removal of Top
Management, etc., and reports the results of
their deliberations to the Board of Directors.
The Compensation Committee deliberates matters
regarding remuneration, bonuses and other
financial benefits paid as consideration for the
performance of duties for Directors and Top
Management, etc. (excluding individual remunera-
tion for Directors who are Audit & Supervisory
Committee Members), and reports the results of
their deliberations to the Board of Directors.
Matters on Policy of determining remuneration amounts and calculation methods
Remunerations for Directors are so designed as to enable the Company to recruit and retain talents, and to
make the remuneration structures and levels fully commensurate with the responsibilities of the position.
The Company endeavors to improve the objectivity of decisions on remuneration levels through measures
such as the use of remuneration survey data from specialist third-party organizations.
Remunerations for internal Directors who are not Audit & Supervisory Committee Members are based upon
a remuneration system and composition that are closely linked to performance with an emphasis on increasing
enterprise value and shareholder value over the medium- to long-term, and are composed of a fixed amount
basic remuneration, bonuses, and stock compensation. The Company appropriately links remunerations with
business performance. Remunerations for outside Directors and Directors are composed of a fixed amount basic
remuneration only. Remunerations for each Director who is not an Audit & Supervisory Committee Member are
determined by resolutions of the Board of Directors within a total ceiling amount approved by the Shareholders
Meeting. Remunerations for each Director who is an Audit & Supervisory Committee Member are determined by
the deliberations of the Audit & Supervisory Committee Members within a total ceiling amount approved by the
Shareholders Meeting. Through the deliberations of the Compensation Committee prior to the resolution of the
Board of Directors, the Company ensures greater transparency and objectivity of the deliberation process for
remunerations for Directors who are not Audit & Supervisory Committee Members.
The Company has set out the policy for determining details of remunerations for individual Directors
in the internal policies concerning remunerations for Directors established by resolution of the Board of
Directors after discussions at the Compensation Committee. The details of said policy are described on
page 85 and subsequent pages.
The Compensation Committee has deliberated on the details of remunerations for individual Directors
who are not Audit & Supervisory Committee Members, including whether such details are in line with the
aforementioned policy, and the Board of Directors has judged that they are in line with said policy with
due respect to the proposal of the Compensation Committee. Meanwhile, remunerations for individual
Directors who are Audit & Supervisory Committee Members are determined by deliberation of Audit &
Supervisory Committee Members.
Remunerations for internal Directors who are not Audit & Supervisory
Committee Members*
Remuneration policies
Remuneration of the Company’s Directors is determined based on the following factors.
1. Competitive remuneration system
A remuneration structure and levels that enable the Company to recruit and retain talents
2. Remuneration system that emphasizes increasing enterprise value and shareholder value
A remuneration system and composition that are closely linked to performance with an emphasis on
increasing enterprise and shareholder value over the medium- to long-term
3. Fair and impartial remuneration system
A fair and impartial remuneration system based on responsibility and results regardless of country or region
* Where “Director” is used in this section, it refers to Directors who are not Audit & Supervisory Committee Members (excluding outside Directors).
71
Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Corporate Governance
Total amount of remunerations, total amount of remunerations by type, and number of Directors
applicable for each category of Directors (FY2021)
Officer classification
Total amount of remunerations by type of remuneration (Millions of yen)
Total amount of
remunerations
(Millions of yen)
(1)+(2)+(3)
Basic
remuneration
(1)
Bonus (2)
Stock
compensation
(3)
Total monetary
remuneration
(1)+(2)
Total
performance-
linked
remuneration
(2)+(3)
Number of
applicable
Directors
Directors who are not Audit & Supervisory Committee
Members (excluding outside Directors)
Outside Directors who are not Audit & Supervisory
Committee Members
Total
Directors who are Audit & Supervisory Committee
Members (excluding outside Directors)
Directors who are Audit & Supervisory Committee
Members (excluding outside Directors)
Total
999
88
1,087
62
64
126
302
88
390
62
64
126
250
—
250
—
—
—
446
—
446
—
—
—
552
88
640
62
64
126
696
—
696
—
—
—
3
5
8
1
3
4
*1 At the 14th Term Annual Shareholders Meeting of the Company held on June 18, 2019, the ceiling amount of basic remuneration for Directors who are not
Audit & Supervisory Committee Members (excluding outside Directors) was resolved to be ¥590 million per year, with the ceiling amount for bonuses
resolved to be ¥1,370 million per year, while the ceiling amount for basic remuneration for outside Directors who are not Audit & Supervisory Committee
members was resolved to be ¥130 million per year. The ceiling amounts do not include the portion of salary paid in the capacity of employees. At the close
of such Annual Shareholders Meeting, the number of Directors who are not Audit & Supervisory Committee Members (excluding outside Directors) was 3
whereas the number of outside Directors who are not Audit & Supervisory Committee Members was 4.
*2 The ceiling amount of remuneration to the Directors who are Audit & Supervisory Committee Members as a group was resolved to be ¥260 million per
year at the 13th Term Annual Shareholders Meeting of the Company held on June 15, 2018. At the close of said Annual Shareholders Meeting, the number
of Directors who are Audit & Supervisory Committee Members was 5.
*3 The amounts of “Basic remuneration” above include the amounts paid to 1 Outside Director who is not an Audit & Supervisory Committee Member who
retired at the close of the 16th Term Annual Shareholders Meeting held on June 18, 2021.
Remuneration levels (base amount) for Directors of the Company on
a per position basis and allocated ratios of remuneration (FY2021)
Base amount (Thousands of yen)
500,000
400,000
300,000
200,000
100,000
40%
33%
27%
40%
33%
27%
%38
%31
%31
0
Representative Director,
Chairman of the board
Representative
Director, CEO
Representative Director,
Executive Vice President
Stock compensation
(medium- to long-term remuneration)
Bonus (short-term incentive remuneration)
Basic remuneration
Bonus (short-term incentive remuneration)
Key performance indicators and details
Key performance
indicators
Assessment
weighting
Variance of
assessment
coefficient
Reasons for the selection of indicators and targets
Remuneration structure
Revenue
25%
0% to 200%
Type of remuneration
Fixed
Basic
remuneration
Fixed remuneration for encouraging job performance consistently aligned with professional responsibilities
Objectives and overview
• Remuneration levels determined based on trends with respect to remuneration benchmark company groupings • Paid in equal installments
every month
Core operating
profit ratio
25%
0% to 200%
Performance-linked remuneration geared to steadily improving results with the aim of achieving the business performance targets each business year
Bonus
(short-term
incentive
remuneration)
• The base amount to be paid upon achieving targets is set as a
proportion of basic remuneration, depending on factors such as
professional responsibilities (consideration placed on trends with
respect to remuneration benchmark company groupings)
• In principle, lump-sum payment immediately subsequent to conclusion
of respective business years around between June and July
• Specific amount to be paid is to be determined within range
of 0% to 200% for the base amount, depending on factors
such as level of achieving business performance targets each
business year
Variable
Performance-linked remuneration to promote the management focused on improving the enterprise value and shareholder value over the
medium- to long-term
Stock
compensation
(medium- to
long-term
incentive
remuneration)
• The base amount is set as a proportion of basic remuneration, depending
on factors such as professional responsibilities (consideration placed on
trends with respect to remuneration benchmark company groupings)
• The number of shares (basic points) to be delivered upon achieving
targets is calculated as the base amount divided by the share price at the
start of the three-year applicable period (the average closing price of the
Company’s shares on the Tokyo Stock Exchange for the month prior to
the start of the applicable period)
• The specific number of shares delivered is to be determined
within a range of 0% to 200% for the basic points, depending on
factors such as the rate of growth attained by the Company share
price over a 3-year period
• In principle, delivered in a single installment around June
occurring immediately after conclusion of the 3-year applicable
period (provided, however that 50% of payment shall be cash
payment)
Core EPS*
25%
0% to 200%
R&D performance
25%
0% to 200%
Total
100%
0% to 200%
* EPS: Earnings per Share
72
Reasons for the selection: To assess the increase in size of business
• Maximum: Target × 105%
• Target: Initially released forecast value
• Minimum: Target × 95%
Reasons for the selection: To assess the increase in business
profitability and operational efficiency
• Maximum: Target × 110%
• Target: Initially released forecast value
• Minimum: Target × 90%
Reasons for the selection: To assess the increase in profit per share
• Maximum: Target × 115%
• Target: Initially released forecast value
• Minimum: Target × 85%
Reasons for the selection: To assess the achievement of
sustainable growth
Target: Set quantitative targets separately for research and
development
(1) Research: Number of new drug candidates
(2) Development: Amount of increase in pipeline value
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Corporate Governance
Stock compensation (medium- to long-term incentive remuneration))
Stock compensation (medium- to long-term
incentive remuneration) is performance-linked
remuneration for promoting management that
emphasizes increase in enterprise value and
shareholder value over the medium- to long-term.
As such, the Company’s shares will be delivered
based on the level of growth of enterprise value
and shareholder value over 3 consecutive
business years (“Applicable Period”), and an
appropriate stock price evaluation indicator will
be set to form a system that is closely linked to
performance.
Total shareholder return (TSR*1) will be
adopted for the stock price evaluation indicator.
The Company’s shares will be delivered and so
forth based on the results of a comparison
between the Company’s TSR and the growth rate
of the Tokyo stock price index (TOPIX) for the
Applicable Period and a comparison between the
Stock price assessment benchmarks and details
Company’s TSR and that of global pharmaceutical
companies (the TSR Peer Group*2) for the
Applicable Period. However, 50% of the delivered
shares are to be paid out upon their conversion to
cash in order for them to be allotted to a fund for
payment of withholding income tax and other
such taxes.
*1 TSR is an acronym for “total shareholder return,” and it refers
to shareholders' total return on investment, encompassing
both capital gains and dividends.
*2 TSR Peer Group refers to the global pharmaceutical com-
pany groupings whose revenue is at least 0.5 times that of
the Company at the time of selection. The selection of
companies may be changed by resolution of the Board of
Directors after deliberation at the Compensation
Committee in cases where it has been deemed that such a
company is inappropriate for inclusion as a selected
company when calculating the assessment results due to
circumstances that include restructuring of the company
during the applicable period or changes to the content of
its business.
Stock price
assessment
benchmarks
Assessment
weighting
Variance of
assessment
coefficient
Reasons for the
selection of
benchmarks
Targets
TSR (1)
(Comparison with
TOPIX growth rate)
TSR (2)
(Comparison with
TSR of global
pharmaceutical
companies)
50%
0% to 200%
50%
0% to 200%
To assess the increases
in enterprise value
and shareholder value
over the medium- to
long-term
Target: Set target range as follows
• Maximum: 200%
• Target: 100% (= TOPIX growth rate)
• Minimum (threshold): 50%
Target: Set target range as follows
• Maximum: 100 percentile (top
ranking)
• Target: 50 percentile (mid-range)
• Minimum (threshold): 25 percentile
(lower quartile)
Total
100%
0% to 200%
Formulas for calculating the number of shares delivered and the amount of cash paid
Number of shares delivered
to respective Directors*
(a) Basic points per position
(b) Assessment coefficient
* 50% of the delivered shares are to be paid out upon their conversion to cash to be allocated to a fund for payment of withholding
income tax and other such taxes.
(a) Basic points per position
= (i) Base amount per position / (ii) Share price at start of Applicable Period
(i) Refer to Remuneration levels (base amount) for Directors of the Company
on a per position basis and allocated ratios of remuneration on P.72
(ii) Average closing price of the Company’s share on the Tokyo Stock
Exchange in the month prior to start of the Applicable Period
(b) Assessment coefficient
= (i) TSR assessment coefficient (1) × 50% + (ii) TSR assessment coefficient (2) × 50%
(i) TSR assessment coefficient (1)
Whereas assessment coefficients are calculated using the formula shown
below, the TSR assessment coefficient (1) is set to zero if the value
calculated is less than 50%.
Company TSR during the Applicable Period + 100%
TOPIX growth rate during the Applicable Period + 100%
=
{(B – A) + C} ÷ A + 100%
(E – D) ÷ D + 100%
A: Simple average closing price of the Company’s shares on the Tokyo Stock Exchange
in the month prior to start of the Applicable Period
B: Simple average closing price of the Company’s shares on the Tokyo Stock Exchange
in the final month of the Applicable Period
C: Total dividend per share pertaining to dividend of retained earnings during the
Applicable Period
D: Simple average TOPIX in the month prior to start of the Applicable Period
E: Simple average TOPIX in the final month of the Applicable Period
(ii) TSR assessment coefficient (2)
TSR of the Company and that of the TSR Peer Group are compared with
respect to the Applicable Period. If the Company’s percentile rank is
mid-range (50 percentile), the assessment coefficient (2) is set at 100%. If it
has a top ranking (100 percentile), the assessment coefficient (2) is set to
200%. If it ranks in the lower quartile, the assessment coefficient (2) is 50%.
If it is below the lower quartile, the assessment coefficient (2) is set to zero.
* TSR of the Company and the TSR Peer Group companies is to be calculated
using the formula shown below.
TSR = {(B – A) + C} ÷ A
A: Simple average closing price of respective companies’ share on the stock
exchanges of the respective companies’ primary listings in the month prior to
start of the Applicable Period
B: Simple average closing price of respective companies’ share on the relevant
stock exchanges as pertains to ‘A’ for the final month of the Applicable Period
C: Total dividend per share pertaining to dividend of retained earnings of the
respective companies during the Applicable Period
TSR assessment
coefficient (1)
(%)
Company TSR
TOPIX growth rate + 100%
200
150
100
50
0
50
100
150
200
(%)
TSR assessment
coefficient (2)
(%)
Company’s TSR
percentile rank
200
150
100
50
0
0%
ile
(Lowest
ranking)
25%
ile
75%
ile
50%
ile
(Mid-range
ranking)
100%
ile
(Top
ranking)
73
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Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Corporate Governance
Systems to Ensure the Appropriate Execution of Business
The Company has set out basic policies for FY2022
regarding the following systems to ensure that the
Company’s business is duly executed.
(1) System concerning the Performance of
Duties
1) System to Ensure the Efficient Performance of
the Duties of Directors
• The Company clearly separates the roles of the Directors,
who participate in decision making of corporate
management policies and corporate strategies, etc., and
oversee business execution as members of the Board of
Directors, and the roles of Top Management (the
President and Chief Executive Officer; the Chief Strategy
Officer; the Chief Administrative Officer and Chief Ethics
& Compliance Officer; the Chief Medical Officer; the
Chief Commercial Officer; the Chief Scientific Officer; the
Chief Financial Officer; the General Counsel and the
Chief Manufacturing Officer are collectively referred to
as “Top Management”), who are responsible for the
execution of business.
• The Board of Directors meeting shall be held at least
once every 3 months and additionally as necessary.
• The Company has established the Executive Committee
and discusses material matters concerning business
strategies, strategies, corporate management and
personnel of the Company and the Astellas Group
companies.
• The Company has established regulations concerning the
committee mentioned above and the “Corporate
Decision Authority Policy” to clarify the powers and
positioning of the committee and the top management
as well as the decision-making process.
• The Company has developed the personnel and organiza-
tion systems to enable the efficient execution of business.
2) System for Maintaining and Controlling
Information regarding the Performance of
Duties by Directors
• The “Global Policy for Records and Information
Management” has been established, based on which the
Company will control and maintain, in an appropriate
manner, information regarding the performance of
duties by the Directors.
• The Company has established systems to ensure that all
documents and materials concerning important
management matters, such as minutes of the meetings
of the Board of Directors and the Executive Committee
are available for inspection by the Directors when
necessary.
(2) Regulations and other Systems regarding
Risk (Risk of Loss) Management
• In order to conduct risk management properly as a
whole group, the Company has categorized the risks into
“risks relating to strategic management decision-making
(risks relating to business opportunities)” and “risks
relating to appropriate and efficient business conduct
(risks relating to the performance of business activities).”
Each division and unit of the Company and the Astellas
Group companies will proactively put the Company’s risk
management initiatives into practice and promote risk
mitigation within the Group and the proper response to
such risks through the following activities:
• With respect to measures dealing with risks relating to
business opportunities, each responsible division and
unit will implement appropriate measures to mitigate
risks within their respective scope of responsibility and
roles according to internal processes and policies for
decision making. Among these risks, matters concerning
material risks will be decided upon deliberation by the
Executive Committee and/or the Board of Directors
depending on the level of materiality.
• With respect to measures dealing with risks relating to
the performance of business activities, the Company
has established “Global” and “Divisional” Risk and
Resilience Management Committees to manage
comprehensively 1) identification and optimal
management activities of risks, and 2) preparedness and
status of crisis response plan and business continuity
plan. Policies relating to such system will be decided
upon deliberation by the Executive Committee and the
Board of Directors. Significant risks identified under the
system and responses to them will be decided upon
deliberation by the Executive Committee and reported
to the Board of Directors.
• In order to enhance the effectiveness of risk manage-
ment operations, the Company will formulate separate
policies and manuals for matters such as disaster control,
information security, and personal information
protection based on the nature of these risks.
74
(3) Compliance System (System to Ensure
that the Performance of Duties by
Directors and Employees Complies with
the Laws, Regulations, and the Articles of
Incorporation)
• The Company has established the “Astellas Charter of
Corporate Conduct” and the “Astellas Group Code of
Conduct” as the core standards of compliance for
officers and employees of the Company and the Astellas
Group companies.
• The Company regards compliance not only as observing
the law but also acting in accordance with social norms
as well as the highest sense of ethics. We have a system
for promoting and embedding the broadly defined
“compliance” across the whole group and do the
following toward its implementation:
• The Company has established the “Global Compliance
Committee” to understand the current situation of
compliance and discuss policies and plans for the
Company and the Astellas Group companies as a whole.
Regional Compliance Committees have also been
established to discuss compliance matters in their
respective regions.
• Under the control of the Chief Administrative Officer and
Chief Ethics & Compliance Officer, Ethics & Compliance,
in collaboration with the relevant divisions of the
Company and the Astellas Group companies, designs
and executes specific plans for global compliance. In
addition, through continuous training and other
measures, we ensure that each officer and employee of
the Company and the Astellas Group companies can
practice compliance on their own initiative.
• The Company has established a global third party
whistle-blowing hotline that is available for all Astellas
Group employees and external stakeholders to report
actual or potential non-compliance.
• The Company has also established a system to ensure
any material information is timely reported to the Chief
Administrative Officer and Chief Ethics & Compliance
Officer. In dealing with such reports, we ensure that
confidentiality will be strictly maintained and unfair
treatment against reporters is strictly prohibited.
• Through the systems and activities mentioned above,
the Company promotes a robust speak up culture with
its strict non-retaliation policy.
(4) System for Disclosure and Management of
Information
• The Company discloses corporate information to all of
its customers, shareholders, community and other
stakeholders in a timely, proper and fair manner. The
Company also actively engages in dialogue with them
and appropriately takes into consideration comments
with respect to its business activities. Through disclosure
and dialogue, the Company is committed to further
enhancing its transparency and striving to build and
maintain a trust relationship with its stakeholders.
• Based on the basic stance above, the Company has
established the “Disclosure Policy” and the “Corporate
Disclosure Committee” that promotes and manages
disclosure activities.
• The Company has established policies concerning the
handling of material information acquired in the course
of the duties by the officers and employees of the
Company and the Astellas Group to prevent violations of
the laws and regulations and to ensure the appropriate
management of information.
(5) System to Ensure the Reliability of
Financial Reports
• The Company will design and operate internal controls
over consolidated financial reports in accordance with
generally accepted standards in order to ensure
reliability of the financial reports, and assess the
effectiveness in an appropriate way.
• In accordance with the “Global JSOX Policy” formulated
by the Board of Directors, assessment of internal
controls over the consolidated financial reports will be
implemented, under the direction of the President and
CEO, who plays the role of the Global Internal Control
Officer.
(6) Group Management System (System to
Ensure the Appropriate Execution of
Business by the Corporate Group
Composed of the Company and its
Subsidiaries)
• The Company engages in appropriate control and
operation of the Astellas Group companies. With this in
mind, the Company has taken the following actions in
order to maintain and build a sound relationship between
it and the Astellas Group companies:
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Corporate Governance
• The Company will apply the “Astellas Charter of
Corporate Conduct” and the “Astellas Group Code of
Conduct” to all of the Astellas Group companies, and it
will ensure that all persons concerned are fully aware of
these policies and the code of the conduct of each
Astellas Group company that are based on these policies.
• The Company has established a system in which matters
concerning performance of the duties by the Directors
of the Astellas Group companies will be reported to the
Company through functional line managers.
• The Company will create clear rules regarding the
composition of executives and decision-making
authority and internal oversight systems at the Astellas
Group companies to ensure the efficient execution of
duties by the Directors of the Group companies.
• As mentioned above, the Astellas Group will tackle risk
management and compliance matters from an
enterprise and global perspective.
• The “Global Internal Audit Policy” will apply to all the
Astellas Group companies and the internal audit system
over the Group will be prepared.
(7) Internal Audit System
• The Company has established the Internal Audit division,
which is independent from the ordinary business
execution divisions and is under the direct control of the
President and CEO, to develop the internal audit system
of the Company and the Astellas Group companies, and
takes the following actions:
• The Internal Audit division will review and evaluate the
effectiveness and efficiency of the systems and
structures in the various management activities of the
Company and the Astellas Group companies, put
together an audit report, and submit the results of such
review and evaluation to the President and CEO and the
Audit & Supervisory Committee. The Internal Audit will
also communicate such results, if necessary, to officers
and divisions concerned. The report concerning the
overall annual audit results will be made to the Board of
Directors and Accounting Auditor.
• The Company will comply with the “Act on Securing
Quality, Efficacy and Safety of Pharmaceuticals, Medical
Devices, Regenerative and Cellular Therapy Products,
Gene Therapy Products, and Cosmetics” and other
regulations as a pharmaceutical company, and conduct
its business with a mission to provide safe and effective
products with a high level of expertise through a fair
organization structure. To this end, the Company has
built a tiered-control structure separated by different
functions in all the Astellas Group companies; namely,
the tiers consist of self-control on-site, expert control by
divisions related to RA and QA, and the internal audits
conducted by the independent Internal Audit division.
• Internal Audit division will promote improvement in the
quality of the internal audits through meetings and
other forms of collaboration with the relevant expert
divisions.
• Through managing the entire global internal audit
function by the head of the Internal Audit division who
directly reports too the President and CEO, and
organizing the Internal Audit division in line with the
functional-based global organizational structure across
all the Astellas Group companies, the Company will
address risks getting more globalized effectively and
enhance the function to provide group companies with
consistent high-quality assurance and advisory services.
(8) System to Ensure Effective Audits by the
Audit & Supervisory Committee
The Company takes the following actions as a “company
with an Audit & Supervisory Committee” to enable
the Audit & Supervisory Committee to carry out their
audit effectively.
1) Matters concerning Employees Assisting
the Audit & Supervisory Committee
• The Company establishes the Audit & Supervisory
Committee Office, and assigns full-time staff to assist the
Audit & Supervisory Committee to carry out their duties,
so that the audit by the Audit & Supervisory Committee
will be properly executed.
2) Matters concerning Independence of the
Employees Assisting the Audit &
Supervisory Committee from the Directors
Who Are Not the Committee Members,
and Effectiveness of Directions Given to
Such Employees
• The staff of the Audit & Supervisory Committee Office
are independent from the Directors who are not the
Committee Members and carries out his or her duties
under the direct control of the Audit & Supervisory
Committee.
• The appointment, evaluation, transfer, and other matters
concerning such staff will require the prior consent of
the Audit & Supervisory Committee.
75
3) System concerning Report of the Directors
Who Are Not the Committee Members
and Employees to the Audit & Supervisory
Committee, and Other Systems
concerning Report to the Audit &
Supervisory Committee
• The Company has established a system to ensure that
the Audit & Supervisory Committee, at any time, can
access monthly reports and quarterly reports regarding
the execution of duties by the Directors of the Company
and the Astellas Group companies.
• Regarding each of the divisions, Top Management
decides reporting matters, persons giving reports and
methods of reporting by mutual agreement with the
Audit & Supervisory Committee.
• The divisions responsible for internal audits, legal matters,
compliance and risk management will each develop a
system to report to the Audit & Supervisory Committee
on a regular basis and will report their current statuses
and provide the necessary information with respect to
the Company and the Astellas Group companies.
4) System to Ensure that Informants Do Not Risk
Unfavorable Treatment due to Their Reporting to
the Audit & Supervisory Committee
• The Internal Audit division will obtain endorsement from
the Audit & Supervisory Committee on the annual plan
of the internal audit.
• The Audit & Supervisory Committee will receive the
report from the Internal Audit division on the results of
the internal audit, and be able to give guidance to the
Internal Audit division as needed. In the case where a
direction from the President and CEO conflicts with one
from the Audit & Supervisory Committee, both parties
will discuss and try to coordinate.
• The Audit & Supervisory Committee Members
appointed by the Audit & Supervisory Committee may
attend the Executive Committee meetings where
execution of the Company’s important business will be
discussed, and also attend other meetings that the Audit
& Supervisory Committee considers as important. In
case that such Audit & Supervisory Committee Members
are not available to attend these meetings, the staff of
the Audit & Supervisory Committee Office may attend as
observers by order of the Audit & Supervisory
Committee.
• The persons (divisions) of the Company and the Astellas
Group companies subject to be audited will cooperate
so that the Audit & Supervisory Committee may perform
the audits in an appropriate manner.
• The Company prohibits any unfavorable treatment of
(9) System to Exclude Anti-social Forces
officers or employees of the Company and the Astellas
Group companies who report to the Audit & Supervisory
Committee of the Company or the Audit & Supervisory
Board Members of the Astellas Group companies,
because of their reporting.
5) Matters concerning Policies to Treat Costs
Incurred by the Audit & Supervisory Committee
for the Execution of Duties
• The Company has established a system that the Audit &
Supervisory Committee Office prepares budgets and
performs payment of costs incurred by the Audit &
Supervisory Committee for the execution of their duties.
6) Other Systems to Ensure Effective Audits by the
Audit & Supervisory Committee
• The appointment, evaluation, transfer, and other matters
concerning the head of the Internal Audit division will
require the prior consent of the Audit & Supervisory
Committee.
• The Company and the Astellas Group companies will
not only take a resolute attitude against any anti-social
forces and groups that threaten the order and security
of society and never succumb to unjust and illegal
requests, but will also keep out such forces and groups.
Accordingly, the Company and the Astellas Group
companies do the following:
• Clearly declare in the “Astellas Charter of Corporate
Conduct” and the “Astellas Group Code of Conduct” that
the Astellas Group will take a resolute attitude against
anti-social forces and groups and exclude any relation
with such forces and groups.
• Particularly in Japan, in close cooperation with the
police and other related parties, establish a solid system
that will enable the Company to actively collect
necessary information as to anti-social forces and
groups, as well as to take organizational actions.
• Continually implement educational activities, such as
training on compliance and risk management, etc., for
officers and employees, so as to exclude anti-social
forces and groups.
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Interview with an Outside Director
Astellas’ corporate governance is
steadily evolving. As the Group
perpetuates a corporate culture that
is unafraid of change, I look forward
to the further enhancement of
corporate value.
Haruko Shibumura
Outside Director,
Audit & Supervisory Committee Member
Q
A
Looking back on your time as an outside Director, how do you evaluate
Astellas’ corporate governance?
Astellas’ corporate governance is steadily evolving, including more effective
auditing by the Audit & Supervisory Committee and more robust deliberation in
meetings of the Board of Directors.
I assumed my role as an outside Director in
2019. In the 3 years since then, the Audit &
Supervisory Committee has reinforced various
initiatives to achieve more effective auditing
and supervision. In meetings of the Board of
Directors as well, every year I have seen more
robust, open discussions on the part of outside
Directors, who possess a wealth of knowledge
and experience. I think that Astellas’ corporate
governance is steadily evolving.
One example of a useful step by the Audit
& Supervisory Committee to better audit the
effectiveness of the Board of Directors is that
the Committee convenes later in the day after
Board meetings, to go over once again the
deliberations and proceedings of the Board
meeting. All Audit & Supervisory Committee
Members play a dual role: They sit on the Board
76
of Directors as Directors themselves, while also
auditing and supervising the performance of
duties by Directors as Audit & Supervisory
Committee Members. I think it is very meaningful
to approach Board deliberations from both
perspectives. Astellas has also established a
system for reporting on deliberations of the
Nomination Committee and the Compensation
Committee* to the Audit & Supervisory Com-
mittee. These initiatives have all begun just in
the past few years, and we will continue to
seek other means of enhancing the effectiveness
of the Board of Directors.
For corporate governance to evolve further,
it is necessary to provide even more compre-
hensive information to outside Directors who
are charged with management oversight. As
we have enhanced the provision of the
information to the Audit & Supervisory
Committee, I feel there is a gap in the amount
of information given between outside Directors
who are Audit & Supervisory Committee
Members and those who are not. Although their
duties differ, I believe shrinking this information
gap will further reinforce the management
oversight function of outside Directors.
* Committees established voluntarily, both of which consist
of at least a majority of outside Directors, and are chaired
by an outside Director. Currently, all members of both
Committees are outside Directors.
Q
A
Please tell us about any particularly distinctive initiatives among the
Audit & Supervisory Committee’s activities in FY2021.
I would mention both the more robust exchange of opinions with Top Management
and the remote audits we carried out.
The first point relates to the information
provided to the Audit & Supervisory Committee
Members I just mentioned. FY2021 saw a much
more robust exchange of opinions with Top
Management. One prerequisite to improving
the effectiveness of the Board of Directors is
sharing information germane to deliberations
in advance with all outside Directors. In addition,
I believe direct dialogue and discussion with
Top Management are indispensable to more
effective auditing and supervision by the Audit
& Supervisory Committee. From this standpoint,
since FY2020 we have established a venue for
exchanging opinions with the CEO, CStO*, and
other Top Management in charge of each
division. These meetings are held once a
month. In the first year out, our focus was on
receiving reports from management and
asking questions about them. In FY2021,
though, we were able to put more stress on
discussions and exchanging opinions than
simply on reporting. Having been able to
make more proactive comments about
information we were given is a significant
Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Interview with an Outside Director
achievement, which I believe greatly helped
us carry out more effective auditing and
supervision. Right now, we are still just
receiving reports and exchanging opinions
but our goal is to go further, making this a
venue where Audit & Supervisory Committee
Members can proactively make recommenda-
tions to Top Management.
The second point is that the COVID-19
pandemic led us to carry out all audits online.
The upside of remote audits is that we could
dramatically increase the frequency of audits
and the number of people involved, and have
the chance to communicate with more
out-of-the-way regions. Throughout the year,
I received direct reports from numerous
overseas site managers and operating officers.
It was a great opportunity to get an even better
feel for issues out in the field, and afforded me
many more occasions to express my opinion
as an Audit & Supervisory Committee Member.
The downside is that on-site audits offer a
number of advantages that remote audits do
not. Going forward, therefore, I would like to
establish a hybrid approach that combines
on-site and remote audits.
* CStO: Chief Strategy Officer
Q
A
Tell us what you value as an Audit & Supervisory Committee Member.
I believe building strong relationships of trust with information providers is
necessary to enhancing auditing.
Throughout my career as a lawyer, I have been
involved in various aspects of corporate
governance and risk management in a number
of companies. This experience made me keenly
aware that a framework for obtaining informa-
tion in a timely manner is indispensable for the
auditing of the Audit & Supervisory Committee
to function fully. The Committee’s role is not
limited to auditing business legality or validity:
I believe it is also extremely vital to audit
management and operations from the
perspective of enhancing corporate value. This
is why it is essential that the Audit & Supervisory
Committee be given key information in a
timely manner. Moreover, the information the
Committee requires access to is wide-ranging.
While having a framework in place to
access information is important in itself, I think
it is even more important that the people who
provide the information and the Audit &
Supervisory Committee have a strong relation-
ship of trust. The committee has to be worthy
of such trust. Without a relationship of trust,
it is impossible to receive useful information.
Building trust is not easy, but from my back-
ground as a lawyer, I think it is crucial to always
take some kind of action after receiving
information. This lets the information provider
realize that providing the information was
meaningful. Trust is built up through a
succession of small interactions like this.
I believe the trust of all stakeholders in the
Audit & Supervisory Committee will lead to
stronger corporate governance for Astellas.
Q
A
Please tell us what you see as Astellas’ strengths and what your hopes are going forward.
One of Astellas’ biggest strengths is a corporate culture that is unafraid of change.
My hope is that Astellas will pursue an HR strategy and other means needed to
preserve and deepen that culture.
Ever since I assumed my role as an outside
Director, Astellas has boldly instituted global
organizational reforms in line with the changing
times. Moreover, Corporate Strategic Plan
2021 sets out an agenda for comprehensive
reform. Astellas is also making changes that
feed directly into greater organizational
transparency, such as instilling a thorough
awareness of compliance and fostering a
culture of speaking up. I believe this kind of
corporate culture that is unafraid of change is
one of Astellas’ biggest strengths.
Human resources are indispensable to
sustaining and continuing to implement
change, and HR strategies are more critical
than ever. As competition for human resources
intensifies on a global scale, it is becoming
more important to consider the kind of talent
Astellas needs specifically, and what kind of
strategy is required both to acquire such talent
and to bring out and cultivate internal potential.
My hope at this point is that Astellas will
continue to focus on its HR strategy, including
its current proactive development of succession
plans and talent reviews, as well as efforts to
make effective use of an array of recruiting
channels. In terms of diversity, I recognize that
the Astellas Group on the whole is becoming
more diverse. However, I feel Japan still has a
long way to go toward empowering women
in the workplace. Companies that lack diversity
among their executives and their executive
candidates responsible for future management
cannot expect to grow sustainably. It is
essential to continue proactively building an
environment in which diverse personnel can
play an active role.
Finally, while Astellas is currently taking
various steps to achieve the goals of Corporate
Strategic Plan 2021, I still see areas where we
can better enhance corporate value. I intend
to do my part to help sustainably enhance
corporate value, carrying out my mission as an
outside Director who is an Audit & Supervisory
Committee Member.
77
Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Risk Management
Business Risks
Regulations and other Systems regarding Risk (Risk of Loss) Management
In order to conduct risk management properly as a whole group, the Company has catego-
rized the risks into “risks relating to strategic management decision-making (risks relating
to business opportunities)” and “risks relating to appropriate and efficient business conduct
(risks relating to the performance of business activities).” Each division and unit of the
Company and the Astellas Group companies will proactively put the Company’s risk
management initiatives into practice and promote risk mitigation within the Group and the
proper response to such risks through the following activities:
(1) Risk Management Framework Relating to the Performance of Business Activities
Astellas’ risk management framework is as follows:
• With respect to measures dealing with risks relating to business opportunities, each responsible
division and unit will implement appropriate measures to mitigate risks within their respective scope
of responsibility and roles according to internal processes and policies for decision making. Among
these risks, matters concerning material risks will be decided upon deliberation by the Executive
Committee and/or the Board of Directors depending on the level of materiality.
• With respect to measures dealing with risks relating to the performance of business activities, the
Company has established “Global” and “Divisional” Risk and Resilience Management Committees to
manage comprehensively 1) identification and optimal management activities of risks, and 2)
preparedness and status of crisis response plan and business continuity plan. Policies relating to such
system will be decided upon deliberation by the Executive Committee and the Board of Directors.
Significant risks identified under the system and responses to them will be decided upon delibera-
tion by the Executive Committee and reported to the Board of Directors.
• In order to enhance the effectiveness of risk management operations, the Company will formulate
separate policies and manuals for matters such as disaster control, information security, and personal
information protection based on the nature of these risks.
Critical Risk
Owners
Designates risk owners
Reports updates on risk mitigation plans
Board of Directors
Reports updates
Executive Committee
Reports/approves results of global risk
and resilience management
Global Risk and Resilience
• Identifies critical risks and designates risk owners
• Discuss risk mitigation plan, proposes it to Executive Committee,
manages and supervises its implementation
• Monitors statuses of emerging risk, crisis response plan,
BCP and ongoing crisis response measures
Major Risk
Owners
Reports results of division risk and resilience management
Standardized processes, definitions, classifications, templates
Research DRRC
Pharmaceutical
Technology
DRRC
Medical &
Development
DRRC
Japan
Commercial
DRRC
Greater China
Commercial
DRRC
International
Markets
Commercial
DRRC
United States
Commercial
DRRC
Established
Markets
Commercial
DRRC
Shares results of global risk and resilience management
* DRRC: Acronym for Divisional Risk and Resilience Management Committee
78
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Risk Management
(2) Identifying and Mitigating Risks Relating to the Performance of Business Activities
Pharmaceutical companies that expand
their business globally are expected to
follow various regulations with a high
level of compliance; Astellas must also
address various risks that could impact its
business results and reputation. In FY2019,
Astellas pursued its operation of enterprise
risk management with the aim of further
developing the risk management activities
implemented until now. This involved
newly establishing the Corporate Risk
Management Division to take control over
risk management, and the Global Risk and
Resilience Management Committee,
chaired by the Chief Administrative Officer
(3) Critical Risks
The risks identified by management as
having the potential to have a considerable
impact on financial position, business results
and cash flow position of the consolidated
companies are mainly set forth below.
and Chief Ethics & Compliance Officer.
Under enterprise risk management,
risks are identified on the Group-wide
level and on the individual division level.
Those risks are classified using a uniform
evaluation process according to priority
and, if deemed necessary, linked to
formulation of a universal means for
solution. Identified risks are regularly
evaluated by the Global Risk and Resilience
Management Committee, and solutions
and mitigation measures for high priority
risks are discussed at the Executive
Committee, chaired by the Representative
Director, President and CEO.
Any forward-looking statements are
based on judgments at the end of FY2021.
1. Risks related to cybersecurity
In recent years, the technology involved in cyberattacks is advancing at an unprecedented level
and the methods of attack are growing more diverse and sophisticated. In light of this environ-
ment, Astellas has identified risks related to cybersecurity as one of its critical risks. The
Information Systems Division is leading the response to this risk, implementing various counter-
measures against cyberattacks on a global basis that includes monitoring of networks and
facilities, and taking every precaution to manage the risk.
However, despite having such measures in place, in the event that business is substantially
interrupted due to a cyberattack or serious system failure, etc., caused by a cyberattack, or in the
event that important data, including information that could identify individuals, is lost,
corrupted or leaked externally, the Astellas Group’s business results may be significantly affected.
2. Risks related to supply chain management
In the pharmaceuticals business, the ability to manufacture safe and effective pharmaceuticals
reliably and then to provide their stable supply is extremely important. Astellas has identified risks
related to supply chain management as one of its critical risks. The Pharmaceutical Technology
Division is leading the response to this risk, establishing its own standards compliant with industry
standard Good Manufacturing Practice (GMP), including manufacturing and quality controls, and
Good Distribution Practice (GDP) and rigorously implementing consistent high-level quality control
for not only manufacturing facilities and equipment but also inclusive of all operations from
ingredient procurement to storage, manufacturing, and delivery.
Furthermore, to respond to growing complexities in the supply chain, the Group has intro-
duced on a global basis, management of its Contract Manufacturing Organizations (CMO) and is
proceeding with measures including the creation of Business Continuity Plans (BCP) to ensure
supply during emergency situations.
However, despite having such measures in place, in the event that interruptions in supply,
product shortage, or quality problems arise, or in the event that the reputation of Astellas is damaged
as a result of the aforementioned, the Astellas Group’s business results may be significantly affected.
3. Risk of impact from pharmaceutical regulations
The ethical pharmaceutical business is governed by a wide variety of regulations in each country.
Astellas has identified changes in pharmaceutical pricing policy by the United States Government as
one of its critical risks and is carefully watching trends.
The Astellas Group’s business results may be significantly affected by policies for controlling the
cost of medical treatment, or a tightening of various regulations concerning development, manufac-
turing and distribution, particularly in developed countries.
In addition to the above critical risks
identified by the Astellas Group, there are
many other risks. Some risks are unique to
the pharmaceuticals business which
include the uncertain nature of research
and development, the risk of being
infringed upon or infringing intellectual
property rights, risk of drug side effects or
safety issues arising thereof, and the risk of
an Astellas Group business’s partial
dependence on licensing and sales of
third-party developed drugs. Other risks
include the risk of infringement of related
laws and regulations concerning competition
with rival products, or environment or
health and safety, or of commercial litigation
regarding business processes, as well as risks
of delays or stoppages in manufacturing
due to natural disaster, etc., or of exchange
rate fluctuation. Such risks may affect the
Astellas Group’s business results and financial
position. Note that the risks stated above do
not cover all of the risks relating to the
Astellas Group.
79
Astellas Pharma Inc. Integrated Report 2022
Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Ethics & Compliance
Enhancing and Sustaining Integrity and Trust
Ethical and Compliant Culture at Astellas
Astellas is committed to long-term,
sustainable growth through creating
and delivering value to patients and
having a positive impact for society.
Keeping patients and integrity at the
heart of what we do is imperative, and
we are passionate about this at Astellas.
To create value for patients we do not
compromise on patient safety, the
quality of our products, or ethics and
compliance – we do not compromise
on integrity.
The Astellas culture is rooted in
integrity, ethics and compliance.
We promote an ethical culture where
people are expected to act with integrity
and put patients first, and the long-term
sustainable success of the Company
as their priorities. Integrity is one of
our Astellas Way values. Together with a
patient-focused mindset, employees
understand how being ethical and
compliant helps them live the
Astellas mission.
Global Compliance Structure (As of September 2022 and it is subject to change)
Chief Ethics & Compliance Officer (CECO)
Head of Ethics & Compliance
Global
Compliance
Committee
Anti-Bribery /
Anti-Corruption
Compliance
Investigations
Compliance
Excellence and
Transformation
Third Party /
Distributor Risk
Data Privacy
Medical and
Development
Innovation
Commercial
Strategies
Greater China
Japan
International
Markets
Established
Markets
US
Ethics &
Compliance Head
Ethics &
Compliance Head
Ethics &
Compliance Head
Ethics &
Compliance Head
Ethics &
Compliance Head
Compliance
Committee
Compliance
Committee
Compliance
Committee
Compliance
Committee
Compliance
Committee
Every aspect of our work to create
innovative healthcare solutions is
connected to evolving sustainability.
The Astellas Ethics & Compliance
Program and our values-based ethical
culture of integrity enables innovation
and bold ideas to foster sustainable value
to patients. We provide risk-balanced,
proactive, innovative, and practical
ethics and compliance guidance, but
more importantly, we support our
employees to make ethical, compliant,
and intelligent business risk-based
decisions. In all aspects of our business,
we do what is right, which includes
following the letter and the spirit of
applicable laws and regulations. This
enables us to grow and keep the trust
we have earned and continue to earn
every day from our patients and our
stakeholders.
At Astellas, all employees are
responsible for creating an ethical
culture. Astellas leaders and managers
are critical to model the Astellas core
values of integrity, and ethics and
compliance within their teams.
Ethics & Compliance works closely
with the leaders and managers to
engage in various initiatives designed
80
to continually enhance and sustain an
ethical and compliant culture at
Astellas. This includes lessons learned
and ethical decision-making workshops
dedicated to providing insight into
key ethical concepts that impact
decision-making. They learn about
practical tools they and their teams can
use, to support ethical decision-making
in their daily business activities.
Our Ethics & Compliance program
supports the fundamental mission to
provide our patients with safe, effective
medical products that improve their
health and well-being. It is designed to
keep the trust that we always act in the
best interests of patients. This is
strengthened through the efforts of
Astellas’ global, regional and local com-
pliance committees and their awareness,
knowledge and understanding of ethics
and compliance in the context of
business operations and activities.
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Ethics & Compliance
Anti-Bribery Anti-Corruption
To achieve our mission, it is essential
that we ensure all Astellas interactions,
including those with HCPs, HCOs and
patient organizations, are conducted
in a legal and ethical manner and
always for the ultimate benefit of
patients. We do this through a
comprehensive Ethics & Compliance
Program with established global
policies, processes and systems, tools
and controls, and by proactively
training employees on healthcare
compliance, conducting compliance
Conflict of Interest
risk assessments and compliance
monitoring, including on aspects of
its ABAC (anti-bribery anti-corruption)
compliance program, to ensure there
is no undue influence or even
appearance of misleading or influencing
a Healthcare Professional. Through
continuous improvement of our ABAC
program, we ensure its effectiveness
by being prepared to address current
and future risks. This enables
sustainability of our culture of Integrity.
It is important to empower ownership
of ethics and compliance within
Astellas. One way we do this is by
how we approach our own conflicts
of interest. That is because the foun-
dation of an effective Ethics and
Compliance program is based on how
a company manages its own internal
behavior. By enhancing the disclosure
process and providing global training
resources, we continue to empower
employees to identify and raise potential
conflicts, resulting in increased
business ownership of compliance.
Data Privacy
We earn society’s trust every day.
Physicians, patients, employees,
suppliers, and other individuals may
share their personal information
with Astellas, and they trust us to
keep that information safe, to use it
transparently, and to always handle
it with care. Our Ethics & Compliance
Program ensures the appropriate use
of the personal information that is
entrusted to us by individuals.
Speaking Up
The Ethics & Compliance Program
embraces all employees to foster an
effective and robust integrity culture
at Astellas by ensuring a psychologi-
cally safe speak up environment.
Ethics & Compliance continuously
encourages employees to speak up to
report potential or actual violations of
the Group Code of Conduct, as well as
any unethical behavior or business
practices, or receive advice on how to
react in the event they discover or
suspect misconduct.
For the Future
For the future, we will continue to
evolve our Ethics & Compliance
Program, ensuring that it is aligned to
the evolving nature of our internal
and external environment and focused
on serving patients and stakeholders.
We will take opportunities to adopt
innovative tools and techniques that
enhance the effectiveness and the
81
Speak Up is critical to ensure our
integrity culture at Astellas. This Speak
Up culture is further supported and
enabled by a global investigations
program that is prompt, fair, robust
and objective.
efficiency of our program. By putting
the patient first and making decisions
that support delivering innovation
with agility and integrity, we create a
long-term and sustainable future that
will continue to add value to patients
and reinforces the trust on which our
success is founded.
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Corporate Data
Corporate Data
CONTENTS
Corporate Data
Major Pipeline
Financial Data
Non-financial Data
Company Overview
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89
91
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Corporate Data
Major Pipeline
(as of July 2022)
The list shows the development status in the target diseases for which we aim to obtain approval in Japan, the United States, Europe and/or China.
XTANDI and Strategic products
Modality / Technology
Classification
Target disease
Generic name
Code No.
(Brand name)
enzalutamide MDV3100
(XTANDI)
Small molecule
Androgen receptor inhibitor
1
2
3
F
Phase*1
China
enfortumab vedotin
ASG-22ME (PADCEV)
Antibody-drug conjugate
(ADC)
Nectin-4 targeted ADC
gilteritinib ASP2215
(XOSPATA)
Small molecule
FLT3 inhibitor
Metastatic castration-sensitive prostate cancer
Non-metastatic castration-sensitive prostate cancer
Metastatic urothelial cancer, previously untreated
(first line; combo with pembrolizumab)
Muscle-invasive bladder cancer
(combo with pembrolizumab)
Other solid tumors
Non-muscle-invasive bladder cancer
Post-chemotherapy maintenance acute myeloid leukemia
Post-hematopoietic stem cell transplant maintenance acute
myeloid leukemia
Newly diagnosed acute myeloid leukemia with high intensity
induction of chemotherapy
Newly diagnosed acute myeloid leukemia with low intensity
induction of chemotherapy
Acute myeloid leukemia in pediatric patients
Gastric and gastroesophageal junction adenocarcinoma
Pancreatic adenocarcinoma
zolbetuximab
IMAB362
roxadustat ASP1517/
FG-4592 (EVRENZO)
fezolinetant
ESN364
Antibody
Anti-Claudin 18.2 monoclonal antibody
Small molecule
HIF-PH inhibitor
Chemotherapy-induced anemia
Small molecule
NK3 receptor antagonist
Vasomotor symptoms associated with menopause
US
Submitted (Jun 2022)
Europe
China
Japan
resamirigene bilparvovec
AT132
Gene therapy
(AAV-based gene therapy)
MTM1 gene replacement to express
myotubularin
X-linked myotubular myopathy
In-house
(Audentes Therapeutics)
*1 Compounds are developed globally unless noted. The list shows the most advanced stage if the stages are different depending on the region. The list specifies the area if the compound is developed in limited areas. The details of numbers and letters are as follows:
1: P-I, 2: P-II, 3: P-III, F: Filed
*2 Compounds with “In-house” in this column include ones discovered by collaborative research.
83
Licensor*2
Pfizer
In-house
[Co-development
with Seagen]
In-house
In-house
(Ganymed)
FibroGen
In-house
(Ogeda)
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Focus Area approach
Primary Focus
Generic name
Code No.
Modality / Technology
Classification
Target disease
Phase*1
1
2
3
F
Licensor*2
ASP9801
Oncolytic virus
Oncolytic virus carrying IL-7 and IL-12
Cancer
ASP7517
Cell therapy (artificial adjuvant vector cells)
WT1 loaded artificial adjuvant vector cell
Acute myeloid leukemia and myelodysplastic
syndrome
Solid tumor
ASP0739
ASP1570
ASP2138
ASP7317
Cell therapy (artificial adjuvant vector cells)
NY-ESO-1 loaded artificial adjuvant vector cell
Cancer
Small molecule
DGKζ inhibitor
Cancer
Antibody
Cell therapy
Anti-Claudin 18.2 and anti-CD3 bispecific
antibody
Gastric and gastroesophageal junction
adenocarcinoma, pancreatic adenocarcinoma
Retinal pigment epithelium cells
Geographic atrophy secondary to age-related
macular degeneration, Stargardt disease
bocidelpar
ASP0367/MA-0211
Small molecule
PPARδmodulator
Primary mitochondrial myopathies
Duchenne muscular dystrophy
ASP8731/ML-0207
Small molecule
BACH1 inhibitor
Sickle cell disease
resamirigene
bilparvovec AT132*3
Gene therapy (AAV-based gene therapy)
MTM1 gene replacement to express
myotubularin
X-linked myotubular myopathy
Gene therapy (AAV-based gene therapy)
GAA gene replacement to express GAA enzyme
Pompe disease
Immuno-Oncology
Blindness and
Regeneration
Mitochondria
Genetic regulation
(Other projects
with Focus Area
approach)
AT845
FX-322
ASP0598
ASP3082
Small molecule
Recombinant protein
Inner ear progenitor cell activator (combination
of GSK-3 inhibitor and HDAC inhibitor)
Sensorineural hearing loss
Recombinant human heparinbinding
epidermal growth factor-like growth factor
Chronic tympanic membrane perforation
Auration Biotech
Small molecule
KRAS G12D degrader
Cancer
In-house
*1 Compounds are developed globally unless noted. The list shows the most advanced stage if the stages are different depending on the region. The list specifies the area if the compound is developed in limited areas. The details of numbers and letters are as follows:
1: P-I, 2: P-II, 3: P-III, F: Filed
*2 Compounds with “In-house” in this column include ones discovered by collaborative research.
*3 AT132 is also listed in “XTANDI and Strategic products”.
84
Tottori University [Discovered
through collaborative research]
RIKEN [Discovered through
collaborative research]
RIKEN [Discovered through
collaborative research]
In-house
Xencor [Discovered through
collaborative research]
In-house
(Ocata Therapeutics)
In-house
(Mitobridge)
In-house
(Mitobridge)
In-house
(Audentes Therapeutics)
In-house
(Audentes Therapeutics)
Frequency Therapeutics
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Others
Generic name
Code No.
mirabegron
YM178
peficitinib
ASP015K
Modality / Technology
Classification
Target disease
Phase*1
1
2
3
F
Licensor*2
Small molecule
β3 receptor agonist
Neurogenic detrusor overactivity in pediatric
patients
Overactive bladder in pediatric patients
Europe
Europe
In-house
Small molecule
JAK inhibitor
Rheumatoid arthritis
China
In-house
isavuconazole
Small molecule
Azole antifungal
Invasive aspergillosis and mucormycosis in
pediatric patients
US
Basilea
ASP8062
Small molecule
GABAB receptor positive allosteric modulator
Alcohol use disorder
In-house
*1 Compounds are developed globally unless noted. The list shows the most advanced stage if the stages are different depending on the region. The list specifies the area if the compound is developed in limited areas. The details of numbers and letters are as follows:
1: P-I, 2: P-II, 3: P-III, F: Filed
*2 Compounds with “In-house” in this column include ones discovered by collaborative research.
Rx+ Program
Category
(Business area)
Digital health
Other services
Program
Concept
Status*
Partner
Game application for exercise support
Smartphone application to support exercise using motion sensing technology for people who
need regular exercise
Under development
BANDAI NAMCO Entertainment
Fit-eNce
Fit-eNce Home
BlueStar
Service to provide scientifically evidenced exercise programs and systems supporting regular
exercise
Under test marketing
Service to provide scientifically evidenced exercise programs and systems supporting regular
exercise at home
Under test marketing
Digital therapeutics for adults with diabetes
Under test marketing
Welldoc
Drug-device combination
pudexacianinium chloride
ASP5354
Precision surgery-guide enabling identification of ureter in hysterectomy and colorectal
surgery, etc.
P-III
* The list shows the most advanced stage if the stages are different depending on the region.
85
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Corporate Data
Financial Data
Income Statement
IFRS core basis
Revenue
Gross profit
SG&A expenses
R&D expenses
FY2013
FY2014
FY2015
FY2016
FY2017
FY2018
FY2019
FY2020
FY2021
(one million yen)
1,139,909
1,247,259
1,372,706
1,311,665
1,300,316
1,306,348
1,300,843
1,249,528
1,296,163
809,281
914,062
1,037,110
991,162
1,006,066
1,014,299
1,024,104
1,003,465
1,043,154
397,018
452,522
500,359
470,777
478,330
490,263
499,295
504,316
548,840
191,460
206,594
225,665
208,129
220,781
208,682
224,226
224,489
246,010
Core operating profit
186,253
216,500
267,456
274,554
268,698
278,514
277,758
251,375
244,744
Core profit for the year
132,796
153,244
198,802
213,343
204,326
249,343
223,178
209,906
190,584
R&D cost-to-revenue ratio (%)
Core operating profit ratio to revenue (%)
16.8
16.3
16.6
17.4
16.4
19.5
15.9
20.9
17.0
20.7
16.0
21.3
17.2
21.4
18.0
20.1
19.0
18.9
IFRS full basis
Core operating profit
116,806
185,663
248,986
260,830
213,258
243,912
243,991
136,051
155,686
Profit before tax
Profit for the year
121,975
189,683
261,770
281,769
218,113
248,967
245,350
145,324
156,886
90,874
135,856
193,687
218,701
164,679
222,265
195,411
120,589
124,086
Operating profit ratio to revenue (%)
10.2
14.9
18.1
19.9
16.4
18.7
18.8
10.9
12.0
* The Company discloses financial results on a core basis as an indicator of its recurring profitability. Certain items reported in financial results on a full basis that are deemed to be non-recurring items by the Company are excluded as non-core items from these financial results on a
core basis. These adjusted items include impairment losses, gain/loss on sales of property, plant and equipment, restructuring costs, loss on disaster, a large amount of losses on compensation or settlement of litigations and other legal disputes, and other items that are deemed to
be excluded based on the Company’s judgment.
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Corporate Data
Financial Data
Statement of Financial Position
FY2013
FY2014
FY2015
FY2016
FY2017
FY2018
FY2019
FY2020
FY2021
(one million yen)
Total assets
Total non-current assets
Total current assets
Total equity attributable to owners of the parent
Total non-current liabilities
Total current liabilities
Ratio of equity attributable to owners of the
parent to gross assets (%)
Dividend on equity (%)
Ratio of equity attributable to owners of the
parent to gross assets (%)
1,653,108
739,816
913,292
1,268,476
43,944
340,688
7.4
5.0
76.7
1,793,578
827,621
965,958
1,317,916
54,771
420,890
10.5
5.1
73.5
1,799,338
901,801
897,537
1,259,209
126,769
413,359
15.0
5.4
70.0
1,814,072
937,407
876,665
1,271,810
142,406
399,856
17.3
5.6
70.1
1,858,205
1,012,587
845,619
1,268,289
168,296
421,620
13.0
5.7
68.3
1,897,648
1,040,489
857,159
1,258,396
141,587
497,665
17.6
5.8
66.3
2,315,169
1,447,655
867,514
1,289,168
227,293
798,708
15.3
5.9
55.7
2,273,628
1,401,040
872,588
1,386,115
295,141
592,372
9.0
5.8
61.0
Statement of Cash Flows
2,332,395
1,409,041
923,354
1,460,308
184,676
687,411
8.7
6.5
62.6
(one million yen)
FY2013
FY2014
FY2015
FY2016
FY2017
FY2018
FY2019
FY2020
FY2021
Cash flow from operating activities
Cash flow from investing activities
Free cash flows
Cash flow from financing activities
Cash and cash equivalents at the end of year
214,257
–26,851
187,406
–89,395
391,374
187,686
–71,476
116,210
–121,118
396,430
313,737
–147,050
166,687
–193,478
360,030
235,612
–73,383
162,229
–166,153
340,923
312,614
–121,799
190,816
–203,429
331,731
258,630
–41,757
216,874
–233,681
311,074
221,998
–389,793
–167,796
181,055
318,391
306,843
–81,894
224,949
–229,479
326,128
257,444
–62,413
195,031
–216,298
315,986
Key Figures per Share
(yen)
FY2013
FY2014
FY2015
FY2016
FY2017
FY2018
FY2019
FY2020
FY2021
Basic earnings per share
Book value per share
Dividend per share
40.45
568.53
135
61.50
600.93
30
89.75
592.58
32
103.69
615.89
34
81.11
641.80
36
115.05
667.29
38
104.15
694.03
40
64.93
748.03
42
67.08
799.26
50
*1 The Company discloses financial results on a core basis as an indicator of its recurring profitability. Certain items reported in financial results on a full basis that are deemed to be non-recurring items by the Company are excluded as non-core items from these financial results on a
core basis. These adjusted items include impairment losses, gain/loss on sales of property, plant and equipment, restructuring costs, loss on disaster, a large amount of losses on compensation or settlement of litigations and other legal disputes, and other items that are deemed to
be excluded based on the Company’s judgment.
*2 The Company conducted a stock split of common stock at a ratio of 5 for 1 with an effective date of April 1, 2014. Earnings per share and book value per share are calculated based on the number of issued shares after the stock split (excluding treasury shares) on the assumption
that the stock split was conducted at the beginning of FY2014.
87
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Corporate Data
FY2018
FY2019
FY2020
FY2021
FY2018
FY2019
FY2020
FY2021
(hundred million yen)
(hundred million yen)
Financial Data
Revenue by region
Japan
United States
Established Markets
Greater China
International Markets
Others
Total
Major Products
XTANDI
PADCEV
XOSPATA
Evrenzo
Betanis/Myrbetriq/BETMIGA
Prograf
XTANDI
Japan
United States
Established Markets
Greater China
International Markets
Total
PADCEV
Japan
United States
Established Markets
Total
Sales of Major Products
(hundred million yen)
FY2018
FY2019
FY2020
FY2021
Established Markets
Total
3,331
4,000
4,584
5,343
Betanis/Myrbetriq/BETMIGA
XOSPATA
Japan
United States
Established Markets
Greater China
International Markets
Total
Evrenzo
Japan
Japan
United States
Established Markets
Greater China
International Markets
Total
Prograf
Japan
United States
Established Markets
Greater China
International Markets
Total
3,695
4,216
3,000
624
1,227
302
3,454
4,435
2,961
604
1,348
207
2,791
4,732
2,932
593
1,111
336
2,588
5,375
3,152
663
1,101
84
13,063
13,008
12,495
12,962
—
25
—
1,472
1,957
323
1,647
1,190
22
148
3,331
—
—
—
—
18
143
2
1,616
1,929
358
2,035
1,354
32
221
4,000
—
18
—
18
128
238
11
1,636
1,827
402
2,386
1,493
49
255
4,584
—
128
—
128
217
341
26
1,723
1,854
472
2,769
1,701
79
322
5,343
18
195
5
217
88
6
20
—
—
—
25
—
—
—
327
808
253
12
72
28
105
9
—
—
143
2
—
2
343
892
282
14
84
38
155
44
0
2
238
11
—
11
351
880
299
22
85
39
189
90
15
7
341
25
1
26
375
872
367
29
81
1,472
1,616
1,636
1,723
454
140
744
313
305
443
132
715
322
317
407
118
642
342
317
382
94
679
381
317
1,957
1,929
1,827
1,854
*1 Sales of products in Japan are shown on a gross sales basis.
*2 Established Markets: Europe, Canada, Australia
*3 Greater China: China, Hong Kong, Taiwan
*4 International Markets: Russia, Latin America, Middle East, Africa, Southeast Asia, South Asia, Korea, Export sales, etc
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Non-financial Data
For details, please visit the following website:
https://www.astellas.com/en/sustainability/esg
Environment
Number of Employees per Region and Turnover Rate*1
日本
3,695
3,454
2,791
2,588
日本
3,695
3,454
2,791
2,588
FY2019
FY2020
FY2021
FY2019
FY2020
FY2021
GHG Emissions Volume*1 (Scope 1, Scope 2) (Tons)
Breakdown of Energy Consumption (TJ)
Volume of Water Resources Withdrawn *2 (1,000 m3)
Waste generation volume*3 (Tons)
Volume of Chemical Substance Emissions*4 (Tons)
Changes in Drainage Volume*5 (1,000 m3)
Scope 1
Scope 2
VOC
Nox
166,138
70,898
95,239
3,656
7,493
13,922
28
16
7,061
123,320
63,276
60,044
3,523
7,564
14,352
22
21
7,038
118,679
63,691
54,988
3,517
7,394
13,882
21
17
6,810
*1 Non-energy GHG emissions are less than 5% of total emissions and therefore not included in the disclosed data.
*2 Target: production facilities and R&D sites.
*3 Target: production facilities and R&D sites.
*4 VOC: all production facilities and R&D sites in Japan.
NOx: all business facilities in Japan (excluding sales offices)
Astellas does not use any equipment that runs on fuel oil, which is a major source of SOx emissions..
*5 Target: Plants and research facilities in Japan.
Social
Employee Ratio per Region and Ratio of Female Managers
Japan
(Astellas Pharma Inc. ·
Group companies)
Other Areas Total
International Markets
Greater China
International Markets
United States
Total
Number of employees*2
Turnover rate
Number of employees
Turnover rate
Number of employees
Turnover rate
Number of employees
Turnover rate
Number of employees
Turnover rate
Number of employees
Turnover rate
Number of employees
Turnover rate
5,608
10.7%
10,275
—
—
—
—
—
—
—
—
—
15,883
11.6%
5,659
4,948
2.6%
*3 18.07%
9,796
15.3%
3,608
10.9%
1,325
9,574
15.7%
3,454
14.1%
1,183
*3 41.1%
*3 30.18%
1,524
12.9%
3,339
10.9%
15,455
10.6%
1,445
22.7%
3,492
9.3%
14,522
16.5%
FY2019
FY2020
FY2021
*1 Regional data for 2019 (Established Market, Greater China, International Market, USA) are not aggregated due to regional classifica-
tion changes.
*2 The turnover rate in Japan excludes people retiring at the mandatory retirement age and employees moving outside of the Group
日本
3,695
3,454
2,791
2,588
Japan
(Astellas Pharma Inc. ·
Group companies)
Other Areas Total
Average
Male
Female
Ratio of female managers
Male
Female
Ratio of female managers
Male
Female
Ratio of female managers
70.7%
29.3%
10.2%
43.4%
56.6%
51.6%
53.0%
47.0%
40.0%
70.8%
29.2%
11.6%
44.1%
55.8%
52.6%
53.9%
46.1%
41.2%
69.1%
30.9%
13.3%
44.8%
55.2%
53.5%
53.1%
46.9%
43.9%
*1 Expatriate employees seconded within the Astellas corporate group are included in the headcount of their current location.
Expatriate employees seconded out of the Astellas corporate group are excluded from the headcount.
*2 As of June 2022, the ratio of females in the Board of Directors was 30% and the ratio of females in managerial positions in Japan
was 14.5%.
89
due to transfer of Group businesses.
*3 Implemented early retirement incentive system.
Average Length of Service (Years) By Gender (As of March 31, 2022, Japan consolidated basis.)
日本
3,454
2,791
2,588
FY2019
FY2020
FY2021
Male
Female
18.5
13.8
18.4
13.4
17.4
13.0
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Non-financial Data
Employment (Japan)
Occupational Health & Safety
日本
3,695
3,454
2,791
2,588
日本
3,454
2,791
2,588
FY2019
FY2020
FY2021
Global
2019.1–12
2020.1–12
2021.1–12
New graduate hires
(Astellas Pharma Inc. · Group companies)
Mid-career hires
(Astellas Pharma Inc. · Group companies)
Total
Male
Female
Total
Male
Female
122
60
62
78
48
30
66
41
25
78
51
27
71
38
33
96
71
25
Number of work-related injuries (leave of absence)
Frequency rate of work-related injuries
Severity rate of work-related injuries
19
0.58
0.244
6
0.18
0.005
10
0.33
0.008
* Number of work-related injuries (leave of absence), frequency rate of work-related injuries and severity rate of work-related injuries
for 2019 have been revised due to its recognition in 2021 as an occupational accident. Severity rate of work-related injuries for 2020
has been revised due to settlement of days lost in an occupational accident in 2021.
Governance
Data-Related Life Event (Japan)
日本
3,695
3,454
2,791
2,588
FY2019
FY2020
FY2021
Life Event
FY2019
FY2020
FY2021
日本
3,695
3,454
2,791
2,588
Paternity Leave
Leave for Child Care
Time off for Infant Care
Child-raising
Shortened Work Hours for Childcare
Use of the Company’s Vehicles for Child
Raising
Financial Assistance for Daycare
Paid Leave for Employees Returning to
Work After Leave of Absence Before and
After Childbirth/Leave for Child Care
Nursing Care Holiday
Nursing care
Leave for Nursing Care
Shortened Work Hours for Nursing Care
Child care,
nursing care,
injury, other
Working at Home
104
Female: 190
Average days
used: 402
Male: 11
Average days
used: 60
12
186
Average days
used: 1166
Male: 10
Female: 36
3
45
28
0
95
Female: 195
Average days
used: 396
Male: 13
Average days
used: 29
14
176
Average days
used: 1037
Male: 17
Female: 39
3
24
20
0
̶
0
Registered
Employees for the
Program: 4,501
̶
1
Registered
Employees for the
Program: 5,214
96
Female: 186
Average days
used: 399
Male: 27
Average days
used: 91
14
206
Average days
used: 1185
Male: 22
Female: 57
1
24
22
0
—
3
Registered
Employees for the
Program: 6,014
*1 The number of users indicates those who used the system in each fiscal year.
*2 This figure excludes cases where the term of leave was not completed by the end of each fiscal year. In other words, it is limited to
cases which ended within the fiscal year.
90
structure
Board of Directors
Board of Directors (Persons)
Of which Outside Directors (Persons)
Ratio of Outside Directors (%)
Of which Female Directors (Persons)
Ratio of Female Directors (%)
Number of meetings of the Board of Directors (Number)
Average rate of Outside Directors’ attendance of meetings of
the Board of Directors (%)
Audit & Supervisory
Committee structure
Audit & Supervisory Committee Members (Persons)
Of which Outside Directors (Persons)
Of which Female Directors (Persons)
Number of meetings of the Audit & Supervisory Committee (Number)
Average rate of Outside Directors' attendance of meetings of the
Audit & Supervisory Committee (%)
Nomination Committee
structure
Chair
Member of the Nomination Committee
(including Chair) (Persons)
Of which Outside Directors (Persons)
Number of meetings of the Nomination Committee (Number)
Average rate of Outside Directors' attendance of meetings of
the Nomination Committee (%)
Compensation
Committee structure
Chair
Member of the Compensation Committee
(including Chair) (Persons)
Of which Outside Directors (Persons)
Number of meetings of the Compensation Committee (Number)
Average rate of Outside Directors' attendance of meetings of the
Compensation Committee (%)
12
7
58%
3
25%
14
96%
5
3
2
15
11
7
64%
2
18%
15
100%
4
3
1
15
11
7
64%
1
9%
13
99%
4
3
1
14
96%
100%
100%
Outside
Director
Outside
Director
Outside
Director
5
4
8
5
4
7
5
4
7
95%
Outside
Director
100%
Outside
Director
96%
Outside
Director
5
4
8
5
4
7
5
4
8
95%
100%
100%
Astellas Pharma Inc. Integrated Report 2022 Interview with the CEO
Value Creation Story
Progress of Corporate
Strategic Plan
Strengthening Governance
Corporate Data
Company Overview
(As of March 31, 2022)
Company Information
Company Name
Astellas Pharma Inc.
Headquarters
Foundation
Capital
2-5-1, Nihonbashi-Honcho, Chuo-Ku, Tokyo 103-8411, Japan
1923
103,001 million yen
Representative Director
Kenji Yasukawa (President and Chief Executive Officer)
Employees
3,943 (Unconsolidated) 14,522 (Consolidated)
Share Price and Volume
Stock Price
(Yen, Point)
2,500
2,000
1,500
1,000
Stock Information
Status of shares
Securities Code
4503
Listed Stock Exchange
Prime Market
Fiscal Year-end
General Meeting of
Shareholders
March 31
June
Minimum Trading Unit
100 shares
Total Number of
Authorized Shares
Number of Shares Issued
and Outstanding
9,000,000,000 shares
1,835,851,575 shares
(Including 911,834 shares of
treasury stock)
Number of Shareholders 86,322
Trends in shareholder-type ratio
2.8
March 31, 2020
(87,568)
March 31, 2021
(93,953)
March 31, 2022
(86,322)
4.3
4.6
0
35.6
3.2
8.6
38.3
3.1 8.6
Custodian of Register of Shareholders
Sumitomo Mitsui Trust Bank, Limited
1-4-1, Marunouchi, Chiyoda-ku, Tokyo
100-8233, Japan
Accounting auditor
Ernst & Young ShinNihon LLC.
49.8
45.6
45.5
0.1
0.1
0.0
38.4
20
3.2
8.2
40
60
80
100（%）
Securities Companies
Individuals, other
Financial institutions
Foreign entities, etc.
Other companies
Treasury stock
91
500
0
2012/3
2013/3
2014/3
2015/3
2016/3
2017/3
2018/3
2019/3
2020/3
2021/3
2022/3
0
Astellas (Left scale)
TOPIX (Left scale) ■ Volume (Right scale)
* The Company conducted a stock split of common stock at a ratio of 5 for 1 with an effective date of April 1, 2014.
Major Shareholders (Top 10)
Name of shareholders
The Master Trust Bank of Japan, Ltd. ( Trust account)
Custody Bank of Japan, Ltd. ( Trust account)
STATE STREET BANK AND TRUST COMPANY 505001
NIPPON LIFE INSURANCE COMPANY
STATE STREET BANK WEST CLIENT - TREATY 505234
JP MORGAN CHASE BANK 385781
SSBTC CLIENT OMNIBUS ACCOUNT
GOVERNMENT OF NORWAY
STATE STREET BANK AND TRUST COMPANY 505103
Custody Bank of Japan, Ltd. (Securities Investment Trust Account)
Number of
shares held
(Thousands of shares)
396,257
136,113
65,334
51,588
32,679
25,011
23,632
23,348
20,160
20,105
Shareholding
percentage (%)
21.59
7.41
3.56
2.81
1.78
1.36
1.28
1.27
1.09
1.09
* Number of shares held are presented by discarding the numbers down to the thousand, and percentage of shares are presented by
discarding the numbers down to the third decimal (1,834,939,741 shares).
Trading Volumes
(Thousands of shares)
250,000
200,000
150,000
100,000
50,000
Astellas Pharma Inc. Integrated Report 2022