Integrated Report 2023
For the Year Ended March 31, 2023

Astellas Pharma Inc. Integrated Report 2023

Interview with Chief
Executive Officer

Corporate Strategic Plan for
Value Creation

Value Creation Story

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. Goingforward, 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 ofhealthcare change to turn innovative science into VALUE forpatients and will continually strive to fulfill the expectationsof our stakeholders and society.

01

Strengthen Foundation
for Value Creation

Corporate Data

Interview with Chief
Executive Officer

Astellas Pharma Inc. Integrated Report 2023

Corporate Strategic Plan for
Value Creation

Value Creation Story

Strengthen Foundation
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Corporate Data

Astellas At a Glance(Fiscal year ending March 2023)

Financial Highlights

Countries Where We Do Businessabout

70 countries

Global Network
Japan: 7
United States: 13
Established Markets: 30
International Markets: 21
Greater China: 5

RevenueCore operating profit/
Core operating profit ratio to revenue

R&D expenses

1,518.6 billion¥

286.9 billion/18.9%¥¥(billion yen)(billion yen)

1,518.6

278.5

1,306.3 1,300.8 1,249.5 1,296.2

FY18

FY19

FY20

FY21

FY22

Sales Revenue by Region
Operating CF/Investment CF/FCF*

1.4%

Greater China*3 ¥80.0 billion

United States¥652.4 billion

5.3%

43.0%

International Markets*2¥144.7 billion

9.5%Japan ¥262.3 billion

17.3%

Total
¥

(billion yen)

277.8

21.3%

21.4%

FY18

FY19

286.9
251.4
20.1%

FY20

244.7
18.9% 18.9%

FY21

FY22

Core operating profit
Core operating profit ratio to revenue

Others ¥20.7 billion

FCF: ¥

243.3 billion

23.6%

258.6

306.8

216.9
222.0

–41.8

–81.9

–167.8
FY18

257.4

224.9

60
60

327.8
243.3

195.0

–62.4

–84.5

FY21

FY22

50
38

40

42

FY18

FY19

FY20

–389.8FY19

Operating CF*1 Established markets: Europe, Canada*2 International Markets: Russia, Latin America, Middle East, Africa, Southeast Asia, SouthAsia, Korea, Australia, Export sales, etc.
*3 Greater China: China, Hong Kong, Taiwan

¥

(yen)

1,518.6 billion

Established Markets*1¥358.4 billion

Dividend per share(billion yen)

FY20

Investment CF* FCF: Free cash flows

02

FCF

276.1 billion

FY21

FY22

208.7

FY18

224.2

224.5

FY19

FY20

246.0

FY21

276.1

FY22

Interview with Chief
Executive Officer

Astellas Pharma Inc. Integrated Report 2023

Corporate Strategic Plan for
Value Creation

Value Creation Story

Strengthen Foundation
for Value Creation

Corporate Data

Astellas At a Glance

Sales of Products/R&D Pipeline/Access to Health

Non-Financial Highlight

Sales of Products

GHG Emissions Volume

Sales of Main Products

FY2022 Performance

Target (Base year 2015)

Scope 1+2

Scope 1+2

41.8% reduction

63% reduction

Scope 3

Scope 3

1.8% reduction%
Reduce by
to a level well below 2°C

enzalutamide / XTANDI
for the treatment of prostate cancer

enfortumab vedotin / PADCEV
for the treatment of urothelial cancer

661.1 billion¥¥

44.4 billion

gilteritinib / XOSPATA
for the treatment of acute
myeloid leukemia

mirabegron*1
for the treatment ofoveractive bladdertacrolimus / Prograf*2
immunosuppressant

46.6

¥

188.6 billion¥¥
billion*1 Betanis, Myrbetriq, Betmiga

FY2030198.8 billion

37.5

Engagement score

Response rate

71

82%

• Compared to the previous survey (FY2021)• 33 out of 44 questions showed improvement

R&D
Overseas employee ratio(Number of Programs)

Percentage offemale managers
Global43%

143 million patients 103 countries

Ratio of outside/
female Directors
Japan

18%

Outside Directors

70%

FemaleDirectors

34%

Innovative Drug Businessapprox.

Astellas achieved its existing goals
in 2022, and established new, more
ambitious goals in 2023.

75% of answers to questions
showed improvement

20

Achieve
Net ZeroGlobal Engagement Survey*2 Including Advagraf, Graceptor, ASTAGRAF XL

Prescription drug
Major pipeline

FY205066%* were prescribed Astellas products
cumulatively up to the first half of
FY2022 (estimated)

Outside: Global

03

Inside: Japan

Outside: Outside Directors
Inside: Female Directors

30%Interview with Chief
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Astellas Pharma Inc. Integrated Report 2023

Corporate Strategic Plan for
Value Creation

Value Creation Story

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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

RaisonD’êtreContribute toward improving thehealth of people around the world
through the provision of innovativeand reliable pharmaceutical products

MissionSustainable enhancement ofenterprise value

VISIONO n th e fore f ron t of h e al th care ch an ge

Beliefs

High Sense of Ethics

Creativity

Customer Focus

Competitive Focus

to tur n i n n ov ati ve sci e n ce
i n to VALUE for pati e n ts

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.

04Astellas Pharma Inc. Integrated Report 2023

Interview with Chief
Executive Officer

Corporate Strategic Plan for
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Value Creation Story

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Contents/Editing Policy
CONTENTS
Commercial Strategy Interview with Chief Commercial Officer ................ 48

Message ...........................................................................................................................

01

Astellas At a Glance .......................................................................................................

02

Special Feature II

Our Philosophy and VISION ..........................................................................................

04

Contents/Editing Policy ................................................................................................

05

VEOZAH: New nonhormonal treatment
option for VMS due to menopause ...........................

49

On Publishing Integrated Report 2023 .....................................................................

06

Main Product Sales .......................................................

52

Interview with Chief Medical Officer ........................

53

Areas of Interest .............................................................

54

R&D Strategy

Interview with Chief Executive Officer

07
DX Strategy

59

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Value Creation Story

13

Value Creation Model ....................................................................................................

14

Our History of Value Creation ......................................................................................

16

Management Capital .....................................................................................................

17

The Ideal Company Astellas Aims to Become .........................................................

18

Astellas’ Business Model for Creating Innovation ....................................................

19

Strengthen Foundation for Value Creation

70

Astellas’ Materiality .........................................................................................................

20

Corporate Governance .................................................................................................

71

The VALUE that Astellas Provides ................................................................................

24

Dialogue with Outside Directors ................................................................................

82

Providing Value to Stakeholders .................................................................................

25

Risk Management ..........................................................................................................

86

Scope of the Report

Corporate Strategic Plan for Value Creation

26

Ethics & Compliance ......................................................................................................

88

Period covered: Fiscal year ended March 2023 (April 1, 2022 - March 31, 2023)

Top Management ...........................................................................................................

27

Progress of Corporate Strategic Plan .........................................................................

28

Corporate Data

90

Corporate Strategic Plan 2021 ....................................................................................

29

Financial Data ..................................................................................................................

91

Non-financial Data .........................................................................................................

94

Major Pipeline .................................................................................................................

96

Cautionary Note

Company Overview .......................................................................................................

99

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. These statements
are based on 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
in the forward-looking statements. Such factors include, but are not limited to: (i)changes in general economic conditions and in laws and regulations relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new productlaunches, (iv) the inability of Astellas to market existing and new products effectively,(v) the inability of Astellas to continue to effectively research and develop products
accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Information about pharmaceuticalproducts (including products currently in development) which is included in this integrated report is not intended to constitute an advertisement or medical advice.

Interview with Chief Strategy Officer ........................................................................

Financial Strategy
People Strategy

30
33Interview with Chief People Officer andChief Ethics & Compliance Officer .............................

Sustainability Strategy Interview with

the Head of the Sustainability Division ....................

61

Initiatives for Contribution to Sustainability ...........

62

36

Special Feature I

Roundtable: An Evolving Organizational Culture-The Organizational Health Goals at Work- ..............

38

People and Organization for Innovation ..................

43

Engagement, Diversity, Equity and Inclusion .........

47

05

Return one page· As much as possible, we have included the latest information available at thetime 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 inJapan and overseas (referred to in this report as “Astellas”)

Astellas Pharma Inc. Integrated Report 2023

Interview with Chief
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Corporate Strategic Plan for
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On Publishing Integrated Report 2023

In publishing an integrated report each year, we seek to inform our stakeholders in an easy-to-understand manner of
how our financial and non-financial initiatives both enhance sustainability for Astellas and society, and contribute tosustainable enhancement in enterprise value.
Astellas published its first integrated report in FY2022, in which we reported on progress in implementing
Corporate Strategic Plan 2021 (CSP2021; our medium-term management plan kicking off in FY2021),
while conveying just how Astellas creates and delivers VALUE as the company whose VISION is “to be at theforefront of healthcare change to turn innovative science into VALUE for patients.”
In this second such report, Integrated Report 2023, Astellas’ Top Management talk directly of their commitment
to achieving the goals set in CSP2021, while also discussing Targeted Protein Degradation, the Primary Focus newly
added in FY2022, and VEOZAH (fezolinetant), a treatment for vasomotor symptoms accompanying menopause thatreceived approval in the US in May 2023. To detail how the corporate culture is evolving through pursuit of ourOrganizational Health Goals, Integrated Report 2023 also describes round-table discussions between employees,

Naoki Okamura
Representative Director, President and CEO

Top Management, and outside Directors, as well as conversations between two outside Directors about their current
perception of Astellas.
I hope that this Integrated Report 2023 will help promote dialogue with our stakeholders while also furthering
the understanding of Astellas.

06

Astellas Pharma Inc. Integrated Report 2023

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Corporate Strategic Plan for
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Astellas is firmly committed to achieving the goals set in
Corporate Strategic Plan 2021 (CSP2021), as a cutting-edge
VALUE-driven life science innovator with our VISION ofturning innovative science into VALUE for patients.

Q

You were newly appointed as CEO in FY2023. As CEO, what do you feel particularly strongly about?

I will make every effort to ensure that Astellas meets the goals set in CSP2021,
as a cutting-edge VALUE-driven life science innovator.
I was appointed as head of Corporate Strategy in 2016 and have spent the seven years since then formulating andimplementing Astellas’ corporate strategy. The current Corporate Strategic Plan 2021 (CSP2021) really embodies myconvictions, and I am particularly honored to be entrusted with the finishing touches.
Continuous innovation is critical to achieving our goal of being a Cutting-edge, VALUE-driven life science innovator.
We have adopted a Focus Area approach in our R&D strategy and are working to create innovative products that respondflexibly to rapid advances in science and the accompanying changes in how we perceive and treat diseases. We are also
committed to developing products that not only reduce a patient’s symptoms but can significantly transform theunderlying causes of disease, such as cell therapies and gene therapies. In the Rx+ business, we are also striving tointegrate innovative medical technology with cutting-edge technology in various other fields, leveraging the strength
we have cultivated through our prescription medicine business. We aim to deliver VALUE for patients in various ways

Naoki Okamura
Representative Director, President and CEO

across the whole patient journey (overall medical care, including diagnostic, preventive, therapeutic and prognostic care).
I strongly believe that my own role as CEO is to foster a corporate culture in which every employee exercises theirfull potential in striving to excel as One Astellas, with a sense of urgency that “our patients are waiting.”

07

Astellas Pharma Inc. Integrated Report 2023

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Corporate Strategic Plan for
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Interview with Chief Executive Officer

Q

Could you describe your own aspirations for Astellas, and the initiatives being taken toward fostering that corporate culture.

I envision an organization in which every employee understands CSP2021, creating an environment thatencourages mutual respect and the frank exchange of opinions.
In formulating CSP2021, we set Organizational Health Goals (OHGs), which are steps to fostering a corporate culture in which:Corporate Strategic Plan 2021

Strategic Goals
Strategic Goal 1: Enable patients to achieve better outcomes
Strategic Goal 2: Translate innovative science into
proven VALUE
Strategic Goal 3: Advance the Rx+ business
Strategic Goal 4: Deepen our engagement in sustainability

We learn from our mistakes and take intelligent risks based on bold ideas.
Every employee thinks for themselves and demonstrates leadership commensurate with their role.
We strive to excel as One Astellas, transcending departmental and regional lines.

Organizational Health Goals

This mindset stems from a personal experience that prompted a change in my leadership style. When Astellas acquired OSI

Brave ideas pursue ambitious outcomes

Pharmaceuticals in 2010, I was seconded to the US to spearhead the integration process. Up until then, I was the type of person
who would take sole responsibility for any job I tackled, but in that role, I encountered many new experiences, bringing me to realize

Talent and leadership thrives
We excel as one Astellasthat not everything can be handled alone. This led me to radically alter my leadership style to one of placing more trust in my teammembers and delegate albeit all the while providing encouragement and support to aid members in accomplishing their tasks.
I now believe that if I can suppress the urge to be out front and instead delegate to team members, those individuals will develop asense of responsibility and motivation to get their task done.
I take the same approach with other members of the executive team. Overall, our current executive team is comparatively new tothe job, with some members only joining this fiscal year. Our executive team members have diverse experiences, and to facilitate
teamwork while leveraging each individual’s expertise, we have been holding face-to-face team-building workshops. While thisinitiative is only a few months old, I feel that team members’ psychological safety is building day by day. If members of the executive

Performance Goals
Aim to become a company with a Market Cap valued

7

at more than ¥ trillion
in FY2025 by achieving
1 Revenue: XTANDI and Strategic products* sales ≥ ¥1.2

trillion in FY2025

team can set an example for other employees to follow, in terms of working together with mutual respect and not being afraid tospeak their mind, I believe we can foster a corporate culture that promotes confidence in management and Astellas.
“Collaboration” is another key word. As a global company, Astellas has employees with diverse backgrounds, in terms ofnationality and otherwise. Working collaboratively demands mutual respect for each other’s values, which starts with taking the time
to listen. I am not referring to all working together to build consensus or tackle the same tasks. Rather, I speak of exchanging diverse
views and ideas, with the final decision left to the person in charge. It is important also that all team members are pulling in thesame direction while individually fulfilling their specific roles and responsibilities. If we take individual employees’ capabilities and08

2 Pipeline Value: Focus Area projects expected sales ≥ ¥0.5

trillion in FY2030
3 Core Operating Profit Margin: ≥ 30% in FY2025* PADCEV, XOSPATA, zolbetuximab, Evrenzo, VEOZAH, AT132

Astellas Pharma Inc. Integrated Report 2023

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Interview with Chief Executive Officer
responsibilities and complement these with cooperative relationships, I believe we can build the ideal team and in doing so greatly
enhance collaboration.
With mobility of the talents increasing day by day, there is a considerable gap in expertise between long-time employees of Astellas
and those who have joined Astellas only recently. For example, whereas I am fully across the background to CSP2021, an employee of
only a few weeks’ tenure would know nothing of how we formulated these ideas. I think it is important for longer-standing employeesof Astellas to draw on their experience in enlightening their newer brethren. I strive to set an example in that respect, promotinginternal communication with the aim of ensuring that every Astellas employee properly understands the objectives of CSP2021.

Q

What are Astellas’ greatest strengths when it comes to creating VALUE?

In my view, these are our people, and their shared mission of turning innovative science into
VALUE for patients.
Targeted Protein Degradation (TPD)
Our aspiration is to deliver disruptive clinical benefit for selected cancer patientsby inhibiting pathologic genomic signaling.

To my mind, Astellas’ greatest strength is its people. I believe Astellas’ growth is built on the personal growth and capabilities of its
employees. Individuals do not evolve into fully fledged company people on their own; it is important that those in their orbit
identify areas for improvement as well as strengths that the individual may not be aware of, thereby creating opportunities for
growth. While some believe that a career is built by the individual, I believe environment is important also, including a frameworkfor organizational support. In my own younger days, there were many instances of colleagues looking out for me and showing
me the way. At the same time, Astellas is striving from a company perspective to provide opportunities for individuals to grow.
By encouraging the growth of all employees in this manner, we seek to foster a corporate culture in which innovation comes naturally.
This approach has borne fruit already, one example being a sizable shortening of the timeline for our lead program in theTargeted Protein Degradation (TPD) Primary Focus, newly added in 2022. Usually, it takes about two years for laboratories to

For details about TPD and sizable shortening of the timeline,
please refer to

PP.57–58

commence clinical studies once they have narrowed down a raft of development candidates to just one. In our Primary Focus of
TPD, though, we were able to identify a lead program in only a year or so, much to our surprise. This was achieved not via one
person’s efforts, but rather through the combined ingenuity of team members who each took on a share of risk and were willing to
try a new approach regardless of the difficulties involved. To me, this is a best practice of what can be achieved through individual
awareness of our OHGs.

09

Astellas Pharma Inc. Integrated Report 2023

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Another strength, in my view, is our employees’ shared sense of commitment to turning innovative science into VALUE forpatients, as expounded in our VISION. Astellas employees can often be found using terms such as “patient centricity” and thephrase “the patients are waiting.” Regardless of their department and role, Astellas employees share a common goal of delivering
VALUE to patients.
Sales Forecast (Image)Q

approx. ¥300 bil.

As FY2023 is the third year of CSP2021, it marks a key inflexion point in the five-year plan.
What are you focusing on this year?

We are putting everything in readiness for ensuring that VEOZAH reaches patients sooner rather
than later.

¥

49.3 bil.

Sales growth will directly drive OP growth

Among the three most important initiatives for FY2023, the foremost is ensuring that newly launched products gain traction asplanned. In May this year, we received approval from the U.S. Food and Drug Administration (FDA) for VEOZAH (fezolinetant),

FY2023

FY2024FY2025a treatment for mild to moderate vasomotor symptoms (VMS; feelings of warmth in the face, neck, and chest or sudden intense
feelings of heat and sweating, known as “hot flashes”) associated with menopause. Astellas seeks to address the unmet medical
needs of women in whom VMS adversely affects quality of life, by offering a new treatment option in the form of a non-hormonal

Aim for consolidated core OP margin
more than

30% in FY2025 (CSP2021 target)

therapy. Initially, we will focus on educating healthcare professionals (HCPs) about VEOZAH, before moving on to fully branded
direct-to-consumer activities including commercial campaigns. We seek to work together with HCPs to ensure that VEOZAH isdelivered to VMS patients at the earliest possible juncture.
Second, we are close to demonstrating Proof of Concept (PoC) for some lead programs in our Primary Focus. To hasten PoC,
we delegated authority to each project team to expedite decision-making. While there are no projects expected to reach
PoC in FY2023, we expect a number of projects to yield early clinical results that could pave the way for PoC demonstration in
FY2024 or later.
Third, we are proceeding with cost optimization with a view to achieving our goal of a 30% core operating profit margin in
FY2025, as stated in CSP2021. Unfortunately, in FY2022 the core operating profit margin stayed short of 20%. In FY2023 we willcontinue to make active investments for future growth, but we will continue to make prioritized investments actively for future
growth to improve profitability in FY2024 onward.

10

For details about VEOZAH, please see Special Featur II: “VEOZAH: New
nonhormonal treatment option for VMS due to menopause” on

PP.49-51

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Iveric Bio Acquisition Constitutes New Revenue-generating Pillar
In April 2023, Astellas and IVERIC bio, Inc. (Iveric Bio) entered into a definitive
agreement under which Astellas agreed to acquire Iveric Bio for approximately
US$5.9 billion in cash. The acquisition was completed in July 2023, and Iveric Bio has
become Astellas’ indirect wholly owned subsidiary.
Iveric Bio is a US biopharmaceutical company focusing on discovery and development of therapeutic drugs in the field of ophthalmology. In August 2023, the U.S.
Food and Drug Administration (FDA) approved its lead program, avacincaptad pegol,

Q

In July 2023 Astellas completed the acquisition of US company Iveric Bio.
Tell us of the motivation for the approximately 800 billion yen deal, and management’s views on further M&A.

We decided to acquire Iveric Bio in the view that it would contribute to Astellas’ overall sales
while also providing a capability foundation in the opthalmology field. We remain prepared toconsider various options including acquisitions providing they match our strategic needs.
From a relatively early stage, we have been paying attention to IZERVAY (avacincaptad pegol; developed by Iveric Bio

for the treatment of geographic atrophy (GA) secondary to age-related macular

as a treatment for geographic atrophy secondary to age-related macular degeneration) as a drug that could

degeneration as “IZERVAY (avacincaptad pegol intravitreal solution)”. GA leads tocontribute to the goals of our Primary Focus of Blindness & Regeneration. No clinical data was available at that time,

irreversible loss of vision in patients, and roughly 40% of the patients are considered

but IZERVAY has since yielded favorable results in clinical trials. Based on these results as well as early US sales trend

to become blind. About 1.5 million people in the US are estimated to have GA,of competing drug, we determined that IZERVAY could become a blockbuster and decided to acquire Iveric Bio withmaking this a disease with significant unmet medical needs.
Astellas believes that IZERVAY not only could contribute to achieving the FY2025
sales target set in our Corporate Strategic Plan 2021, but also help compensate forsales decline resulting from the loss of exclusivity for XTANDI in the late 2020s along

a view to augmenting Astellas’ overall sales and also providing a foundation of various ophthalmology-focused
capabilities, thereby accelerating our Primary Focus of Blindness & Regeneration.
I have been involved in business acquisitions for a total of 15 years now. All have been for the purpose of obtaining
new technologies and capabilities from external parties, but only when they align with our strategic goals. If we wantedwith VEOZAH and PADCEV.
The acquisition of Iveric Bio will provide a foundation of ophthalmology-focused
capabilities including a commercial team, access to ophthalmology experts andmedical institutions, know-how in clinical development, and a research platform.
Through these acquired capabilities, Astellas seeks to accelerate development andcommercialization activities to positively contribute to the goals of Primary Focus

to add a new compound to our pipeline, we could do so via a licensing agreement. With a technology that we are able
to harness, we similarly have the option to acquire usage rights only. However, there are some technologies andcompounds that we choose not to take on alone. In such cases we prefer to team up with the licensers or originators
and undertake joint research, potentially going so far as to acquire the licensers and have them continue operating as“Blindness & Regeneration.”part of Astellas. We strongly believe in taking the path that aligns best with our strategy, and to that end we remain

Potential to help compensate for XTANDI LOE as the “third pillar”

prepared to consider various options including acquisitions providing they match our strategic needs.

IZERVAY approval(anticipated)*1 The figure above is forillustrative purposes only, anddoes not represent the exact
figures of each drugs’ sales*2 LOE: Loss of exclusivity
FY2023IZERVAY
VEOZAHIZERVAY
GrowthPADCEV

VEOZAHPADCEVXTANDI
FY2025

LOE* 2XTANDI
FY2030For details on this acquisition, please refer to the relevant presentation materials:
https://www.astellas.com/en/system/files/20230501_presentation_
final_4503_eg_1.pdf

Q

Can you update us on initiatives for evolving sustainability and progress in the Rx+ business
which are included in CSP2021 as Strategic Goals?

We are contributing to societal sustainability through our core business.
The Rx+ business has also made steady progress.
At Astellas, we take pride in pursuing initiatives in our business that contribute to societal sustainability and exert apositive impact on society. With VEOZAH, for example, our aspirations are not limited to the financial objective of11Astellas Pharma Inc. Integrated Report 2023

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increasing product sales. We seek also to support women whose social activities are disrupted by menopause, thereby contributing
to the sustainability of society. Furthermore, we strive to improve access to Astellas products by ensuring the availability of those
products even in countries where we have no business presence.
Needless to say, Astellas also is engaged in environmental initiatives. In terms of the climate change action highly demanded bysociety, not only have we obtained Science Based Targets (SBT) Initiative certification for the 2030 GHG emissions reduction targets
laid out in our Environmental Action Plan, but also we have committed to achieving net zero GHG emissions by 2050.
In our Rx+ business, in FY2023 we drew closer to commercialization of ASP5354, an imaging agent being investigated for
intraoperative ureter visualization in patients undergoing surgery, by initiating and completing a Phase III clinical study. We also haveplans to conduct a clinical study in diabetes patients with the digital health therapeutics we are developing under an allianceagreement with Welldoc, Inc. Furthermore, several projects are poised to enter clinical trials at group company Iota Biosciences, Inc.,
whose proprietary technologies employ ultrasound to provide battery-free power and wireless communication to innovative ultrasmall implantable medical devices that combine biosensing with treatment via stimulation of nerves and muscles. Although the Rx+
business remains small in scale compared with our prescription pharmaceuticals business, just as digital cameras revolutionized thecamera industry, we see potential for a paradigm shift in the world of pharmaceuticals. Our VISION is to bring new VALUE to patients,
and we strongly believe that there are opportunities to provide VALUE across the entire patient journey.

Q

Lastly, do you have a message for investors?

As a man of my word, I will do everything in my power to achieve CSP2021.
For Astellas to have an impact on society, I think it essential that every employee believes that by working at Astellas, they are bothcontributing to patients and achieving self-growth. In my view, the role of Astellas management is to create a corporate culture that

Naoki Okamura

fosters such belief. As a man of my word, I will do everything in my power to achieve CSP2021. Please look forward to Astellas’

Representative Director, President and CEO

continued growth.

12Astellas Pharma Inc. Integrated Report 2023

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Value Creation Story

Value Creation Stor y

CONTENTS
Value Creation Story
Value Creation Model

14

Our History of Value Creation

16

Management Capital

17

The Ideal Company Astellas Aims to Become

18

Astellas’ Business Model for Creating Innovation

19

Astellas’ Materiality

20

The VALUE that Astellas Provides

24

Providing Value to Stakeholders

25

13

Strengthen Foundation
for Value Creation

Corporate Data

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Value Creation Story

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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

ImpactPhilosophy
Raison D’être

MissionSocial issues and requests from society

Beliefs

VISION

to continue to create innovation and deliver innovative medical
solutions that meet the needs of patients.

Business Model

Strategy

P.29

Strategic Goals
1

Enable patients to achieve better outcomes2 Translate innovative science into proven VALUE

3

Advance the Rx+ Business4

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 outcomes2 Talent and leadership thrives

3 We excel as one Astellas

Biodiversity
GovernanceCorporate Governance, Risk Management, Compliance

P.17

Providing value
to stakeholders

P.19

Common Definition of“Value Delivery” through later stage development
and commercialization activities

Corporate Strategic Plan 2021 accelerating realization of VISION

Talent andOrganization
which Create
Innovation

P.24

VALUE

Products derived from FA approaches,
including cell medicine and gene therapy

Outcomes
VALUE =

Primary Focus

P.25

that matter to patients• Genetic Regulation• Mitochondria

Cost to the healthcare• Immuno-Oncology• Targeted Protein
Degradation

system of delivering
those outcomes• Blindness &Regeneration

P.54

Rx+® Healthcare Solutions• ASP5354:
Visualization of theurethra in operations• Wireless medical
implantable devices• Digital therapeutics• ECG analysis service

Performance
Goals

P.29

Sustainableenhancement ofenterprise value
Earning trustfrom stakeholders• Exercise support
serviceP.70

Enhancing management capital
14

Realization ofsustainable society

Fulfill the unmet medical needs by creating and delivering innovative treatments

P.52

DE&I

Reusable energy

Maximize VALUE“VALUE Creation”
through research and development activities

Intellectual Capital
Patents
Know-how for global drug development andcommercialization
Technical capabilities for various new modalities
Social and Relational Capital
Corporate brand
Human network
Collaboration / alliance

OutcomeXTANDI and Strategic Products

Cutting-edge, VALUE-driven life science innovator

Manufacturing Capital
Research facilities
Manufacturing facilities covering commercial production ofcell and gene therapies

Natural Capital
Natural resources

OutputP.20

Business Activity

Financial Capital
Invested capital
Flexible financing for business opportunities

Human Capital
Highly skilled talent

P.04

Key Issues and Materiality

Input

Enhance sustainability ofsociety and Astellas

Solving social issues

innovative and reliable pharmaceutical products,” Astellas is striving

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Our History of Value Creation
Our VISION is updated in CSP2015

Shifts in the Corporate Strategic Plan and strategic areas

Global Category Leader (GCL) model
2005–2010

Urological disease,transplant fields

Apr. 2005

CSP2021

Focus Area Approach

From 2010 onwards

Urological disease, transplant fields,
oncology platform

2015

2018

2010

CSP2018

P.54
2021

2023

Astellas Pharma Inc. was establishedDec. 2007 Astellas acquired
Agensys, Inc.
Acquisition of antibody-drug
conjugate

Entered field ofcancer biology

Dec. 2019Astellas launched PADCEV
Target disease: Urothelial cancer

Sept. 2012
Astellas launched XTANDI
Target disease: Prostate cancer
Entered cell therapy platform
June 2010
Astellas acquired OSI Pharmaceuticals, Inc.
Acquisition of oncology platform in the US

Dec. 2018
Astellas launched XOSPATA
Target disease: Acute myeloid leukemia
June 2023
Astellas has applied for zolbetuximab in US,
Europe, Japan and China
Target disease: Stomach cancer

Dec. 2016
Astellas acquired Ganymed Pharmaceuticals AG
Acquisition of late-stage product zolbetuximab

Nov. 2019Astellas launched Evrenzo
Target disease: Renal anemia

Given major changes in the healthcare industry

May 2017
Astellas acquired Ogeda SA
Acquisition of late-stage product fezolinetantenvironment, Astellas is conducting its research

May 2023
Astellas launched VEOZAH
Target disease: Vasomotor symptoms associated with menopause

Acquisition of newrevenue-generating pillar

activities while incorporating cutting-edge
science from outside the Company, andcontinuously creates new valuable drugs.
Astellas will continue to work on Focus Areas,
where we have a competitive advantage, andturn innovative science into VALUE for patients.

July 2023
Astellas acquired IVERIC bio, Inc.
Acquisition of avacincaptad pegol (ACP)
Acquisition of foundational foundational
ophthalmology

Feb. 2018
Astellas acquired Universal Cells, Inc.
Feb. 2016
Acquisition of universal donor cell technology
Astellas acquired Ocata
Therapeutics, Inc.*1
Dec. 2019
Acquisition of pipeline and leadingAstellas acquired Xyphos Biosciences, Inc.
edge core technology position in
Acquisition of next-generation cancer
ophthalmology and cell therapy
immunotherapy technology

Entered cell therapy platform

Entered genetic regulation platform
Jan. 2020
Astellas acquired Audentes*2 Therapeutics, Inc.
Acquisition of a foundation in adeno-associated virus (AAV)-based gene therapy (AT132, AT845)*1 Renamed Astellas Institute for Regenerative Medicine.
*2 Renamed Astellas Gene Therapies.

LaunchedRx+ business16

Oct. 2020
Astellas acquired Iota Biosciences, Inc.
Acquisition of unique bioelectronics technology

Sept. 2023
Astellas launched IZERVAY
Target disease: Geographic atrophy
secondary to age-related maculardegeneration

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Corporate DataManagement 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
activities that use financial capital, manufacturing capital, intellectual capital, social and relational capital, natural capital, and human capital. By further strengthening thesecapitals, we will realize a sustainable society and sustainable enhancement of our enterprise value.

Financial Capital
Invested capital

While maintaining a sound financial position, our top priority is investment forSocial and
Relational Capital

future business growth. We will be agile in our financing for business
opportunities.

Flexible financing for business opportunities

Manufacturing
CapitalResearch facilities
Manufacturing facilities
covering commercial production of cell and genetherapies

Intellectual
CapitalPatents

Corporate brandWe are promoting our business by leveraging the following: our corporate brandof running our business globally through innovative and reliable pharmaceuticalproducts, a broad human network of our individual employees active in various
specialized fields, and proactive and effective collaboration and alliances withvarious business partners, such as open innovation.

Human network
Share capital:¥1,508 billion (FY2022)

Interest-bearing debt*1:¥125 billion (FY2022)

Collaboration / alliance
Companies/organizations acquired or partneredwith in FY2022:

We have state-of-the-art in-house research facilities and manufacturing facilities

Natural capital

covering commercial production of cell therapy and gene therapy. These arenecessary for creating innovative new drugs and healthcare solutions, and we are

Natural resources

expanding our business globally.

8

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.

Reusable energy
Biodiversity

Volume of water resources withdrawn (1,000 m3):

6,864
0.22
19%

R&D sites:

16 (FY2022)

Water resource productivity (billions of yen per 1,000 m3):

Manufacturing sites:

8 (FY2022)

Renewable energy rate within total energy used:

We possess not only patents related to our products, but also intellectual capital

Human Capitalthat sustains our competitive strength. This takes the form of know-how for global
new drug development and commercialization, and technical capabilities forHighly skilled talentvarious new modalities.

DE&I

using their specialized knowledge and skills, regardless of their race, nationality,
gender, age, or other attributes.
PhDs (globally):

1,281* (as of March 2023)

24

Employees engaged in R&D (Research and Development) incell therapy, gene therapy, and regenerative medicine:933

Number of patent applications published * :Technical capabilities forvarious new modalities

Cumulative number of countries in which above active 104
ingredients and formulations have been approved:(from April 1, 2007 to March 31, 2022)

Cumulative number of active ingredients andformulations newly approved in any country globally:skilled employees. We empower diverse people to contribute to our business

38 (FY2022)

Know-how for global
drug development andcommercialization

2

We drive innovation and create new value through the activities of our highly(from April 1, 2007 to March 31, 2022)

4

Employees engaged in digital science (highly skilled digital talent): 345

Commercialization of various modalities*3, clinical trial experiences

Ratio of non-Japanese and female division heads*5:

53% non-Japanese (37/70),
21% female (15/70)

Succession planning

For details, please refer to*1 Total of corporate bonds, commercial paper, and bank loans. *2 Patent Cooperation Treaty (PCT) applications wherein Astellas Pharma Inc. and/or one or more of its subsidiaries is an applicant. Joint patent applications are included. In-licensed patent applications are not included.
*3 Synthetic drug, antibody, cell therapy, gene therapy. *4 Based on data self-reported by employees; includes directors. *5 Includes those also serving as CxO. Those simultaneously heading multiple divisions counted as one person.

17

P.44

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Value Creation Story

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Corporate Data

The Ideal Company Astellas Aims to Become
Astellas has established an ideal vision for the Company from alonger-term perspective to realize our Philosophy and VISION.

In order to realize our VISION,

For details, please see next page

we are striving to be a cutting-edge, VALUE-driven life science innovator

Philosophy

We will realize sustainable growth by pursuing innovation and VALUE forpatients rather than the level of revenue alone
Astellas will grow as a company that creates and delivers VALUE through healthcare solutions,

VISIONnot only pharmaceuticals• Focus Area approach consistently and efficiently creates and delivers high VALUE pharmaceuticals• VALUE is created through a range of healthcare solutions, that go beyond pharmaceuticals

Concrete Steps to Realize the
Ideal Vision for the Company
from a Longer-Term Perspective

The Ideal
VisionAstellas Is Aiming For• Astellas will not compromise on VALUE for patients in order to drive growth• Astellas will be a Partner of Choice and acquire or leverage attractive technologies and assets
Astellas will excel by purposeful allocation of its resources• High operating profit will be achieved without sacrificing R&D investment sufficient for future innovation• Astellas will keep strong discipline in controlling expenses, including Cost of Goods Sold and SG&A
Astellas will have an innovative culture and organization

Philosophy, VISION, Plan for• Bold decision-making will be supported by intelligent risk-taking

Becoming the Ideal Company• Organizational design will continuously evolve to meet business priorities

Corporate
Strategic Plan
2021

• An increasingly diverse team will be built to drive innovation
Astellas will contribute meaningfully to the sustainability of society with a focus on improving Access to Health andprotecting the environment

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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 andoutcomes around the world by leveraging our strengths.

Business Model
Fulfill the unmet medical needs by creating and delivering innovative treatments

Cu t t i ng - e d g e, VA LUE- d r i ve n l i fe s cie n ce in n ov ator

“ VALUE Creation”“ VALUE Delivery ”

through research anddevelopment activities

through later stage development andcommercialization activities

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 one phrase and it should be understood as follows:
Cutting-edge:

We operate at the forefront of scientific and technologicaladvances to create novel healthcare solutions.

VALUE-driven:

Life science innovator:

Our common definition of VALUE means that everything
we think and do is informed by what leads tomore and better outcomes that matter to patients.

19

We leverage and evolve our capabilities to exploit thegreatest opportunities across the prescription
biopharmaceutical business and beyond,and then continuously bring innovation to life.

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Astellas’ Materiality
Be very highEnhancing sustainability through Materiality initiatives
Astellas recognizes that our efforts to evolve sustainability will lead to increased enterprise value.

Reduction ofenvironmental burden

The environment surrounding both society and business has changed significantly. In response

Talent and organizational culture
for realizing innovation

Access to HealthResponsible supply chain
management

Compliance andethical business practices

to this shifting landscape, in FY2021 we identified and prioritized key issues and updated our

Product quality assurance andproduct safety

Materiality Matrix as a guide to our sustainability efforts.
In preparing a new Materiality Matrix, Astellas identified 19 key issues. We then prioritizednine material issues (Materiality) from this group. We believe that prioritizing and subsequently
addressing the Materiality will set Astellas on the path to “transforming to be a cutting-edge,

Biodiversity
Societal significance

VALUE-driven life science innovator”, and “strengthening resilient and sustainable business operations to meet the expectations of society”. This, in turn, will lead to improved sustainability forboth society and Astellas.

Steps in identifying Materiality

Climate change and energy
DE&I(Diversity, Equity & inclusion)

Fulfilling unmet medical needs
by creating novel
healthcare solutions
Safe and appropriate
use of products
Transformative treatment throughinnovative therapeutic methods
Value-based pricing

Astellas refreshed Materiality Matrix via the steps shown below.
STEP 01: Issue identification

Animal welfare

Data governance

Advocacy

Digital transformation

Patient centricity

We analyzed various references, such as SDGs-related frameworks, stakeholder engagement and communication, topics
covered by ESG ratings, and recent trends in sustainability. We also ensured alignment with Corporate Strategic Plan 2021
(CSP2021) and acknowledged industry-specific issues. As a result, we identified 19 key issues.

Responsible R&D
STEP 02: Issue prioritization
We prioritized the key issues identified from the perspectives of significance to society and Astellas. Societal Significance,Highshown on the vertical axis of the matrix, was determined by considering the depth of interest from global stakeholders
and the scale of economic losses caused by social issues. Significance for Astellas, shown on the horizontal axis,

Significance for Astellas

was determined by assessing Astellas’ opportunities for utilizing its capabilities and assets to contribute to the resolutionHighof issues. The assessment also included management perspectives based on interviews with Top Management.

Be very highImportant

STEP 03: Review and finalization
The prioritized key issues were refined and validated through the information provided by various stakeholders and a series

Very Important

Most Importantof interviews with experts. The Sustainability Advisory Panel* held further discussions before the Executive Committee

Click here to learn more about the definitions of the key issues (PDF)

reviewed and deliberated on the findings. Finally, the Materiality Matrix was approved by the Board of Directors.

https://www.astellas.com/system/files/definition_of_key_issues_en_2022_0.pdf* For details, please refer to

P.62

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Astellas’ Materiality
Sustainability Direction based on analysis of Materiality

Relationship between Materiality and two pillars andenvironmental element of Sustainability Direction

In FY2022, Astellas newly established its Sustainability Direction as a medium-term sustainability
plan for the period through FY2025.

Two pillars for evolving sustainability

Our new Sustainability Direction is closely aligned with CSP2021 and our Materiality Matrix.

By prioritizing and subsequently addressing the Materiality, Astellas is on its way to “transforming to be a

It focuses on Materiality and key issues related to environmental sustainability, which have been

cutting-edge, VALUE-driven life science innovator,” and “strengthening resilient and sustainable business operations

identified in Materiality Matrix.

to meet the expectations of society.”

In establishing our Sustainability Direction, Astellas performed a gap analysis by referencing

1. Transforming to be a Cutting-Edge, VALUE-driven life

2. Strengthening resilient and sustainable business
operations to meet the expectations of society

science innovator

global standards and precedents in each issue. We also conducted discussions in the Sustainability
Advisory Panel and identified the initiatives in need of improvement. We then categorized eachThis is Astellas’ business model for enhancing sustain-

Astellas strengthens our business operations to ensure

ability and providing innovative healthcare solutions by

the stable supply of our products to patients under any

issue into two pillars and environmental element and collaborated closely with relevant divisions

creating and realizing “VALUE.” We will promote initia-

circumstances. We will promote initiatives to address

to summarize “Mid-term priorities for Astellas,” “Initiatives” and “Our commitments by FY2025.”

tives to address the following five material issues.

the following four material issues.

Access to HealthCompliance and ethical business practices

Value-based pricing

Responsible supply chain management

Transformative treatment through innovative
therapeutic methods

Product quality assurance and product safety

Finally, we established our Sustainability Direction. Astellas intends to step up sustainability
advocacy both internally and externally to ensure that stakeholders and society gain a deeper
understanding of Astellas’ path toward value creation.
We plan to revise our Sustainability Direction each time we issue a new corporate strategic plan.

Safe and appropriate use of products

Talent and organizational culture for realizing innovation
Fulfilling unmet medical needs
by creating novel healthcare solutions

Process of establishing our Sustainability Direction

Environmental Sustainability
Gap analysis
Gap andopportunity
Key issues related toanalysisto environmental

sustainability andMateriality identified
in Materiality Matrix

As part of our Materiality initiative, we referenced
stakeholder interviews, global standards andbest practice to gauge Astellas’ performance andidentified the area in need of improvement by
gap analysis.

Companies are required to be actively involved in environmental issues.

Establishmentof
Sustainability
Direction

Reduction of environmental burden

Recognizing that harmony between the global environment and our businessClimate change and energy

activities is a prerequisite to our corporate existence, we shall take proactive
measures to conserve the global environment.
Sustainability
Direction

Initiatives and commitments for contribution to sustainability

Sustainability Advisory Panel
We solicited opinions on the sustainability
initiatives that could be further enhanced fromthe employees’ perspective.

We have established mid-term priorities for Astellas,
initiatives, and our commitments by FY2025 for the
Materiality related to the two pillars and environmental sustainability issues. We will also provide
updates on our progress toward fulfilling ourcommitments.

21

FY2021

FY2022

Revision of theMateriality Matrix

FY2023 FY2025 Contribute toEnvironmental
Establishment of
Sustainability
Sustainability
Direction

Mid-term
priorities forAstellasInitiatives

Our commitments
by FY2025

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Astellas’ Materiality

1

Transforming to be a Cutting-Edge,
VALUE-driven life science innovator
Based on the pillars of Astellas’ business model, “Transforming to be a Cutting-Edge, VALUE-driven life science innovator,”
Astellas will provide innovative healthcare solutions by creating and realizing “VALUE.”

Most important issues (Materiality)

Mid-term Priorities for Astellas

Initiatives

Our Commitments by FY2025

Addressing unmet medical needs for provision ofsolutions that produce better outcomes than previously
possible.

Access to HealthTranslate innovative science into VALUE through the
Focus Area approach to R&D, introducing novel
therapies and modalities to treat diseases with highunmet medical needs.

Aim to improve the lives of patientsand caregivers around the world andcontribute to reducing the overall load on
the healthcare system.

Value-based pricing• Maximize patient access to Astellas’ innovations andenable them to achieve better outcomes.

• Providing comprehensive access programs throughout
the product lifecycle.

• Provide as many patients as possible withaccess to our products.

• Beyond the pharmaceutical space, develop andcommercialize novel healthcare solutions.

• Supporting healthcare system-strengthening programsin partnership and Astellas Global Health Foundation.

• Impact more than 36 million people (cumulatively) by improving disease awareness,prevention, and access to healthcare services.

Advocate a value-based pricing for stakeholders toensure innovative medicines in new modalities
contribute to the health of patients around the world
and realize the sustainable healthcare system.

Advocating for value-based pricing as a basis to support
access to medical innovations.

• Create an environment within Astellas that fosters
innovation.
• Align strategy with the right capabilities, embraced in a
culture that promotes innovation.

Optimizing the number of people under one manager’s
control and reducing layers, reinforcement of succession
planning, and cultivation of a culture ensuring
psychological safety and encouraging active feedback.

Transformative treatment throughinnovative therapeutic methods

Talent and organizational culture
for realizing innovation

Fulfilling unmet medical needs
by creating novel
healthcare solutions

22

Contribute to sustain healthcare systems
through advocating for value-based pricing.

Foster talents and an organizational culture withtrusted capabilities to deliver innovation.

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Astellas’ Materiality

2

Strengthening Resilient and sustainable business operations
to meet the expectations of society
In order to deliver our products to patients under any circumstances, we will respond to the sustainability of society
by focusing on "Strengthening Resilient and sustainable business operations to meet the expectations of society."

Most important issues (Materiality)

Compliance andethical business practices

Mid-term Priorities for Astellas

Initiatives

Sustains a resilient business that continuously supplies
products during unpredictable or emergency situations.

• Sustains a resilient business that continuously supplies
products during unpredictable or emergency situations.
• Enhancing material sourcing and product supply
networks through various means including double
sourcing and diversified distribution bases.

Product quality assurance andproduct safety
Responsible supply chain
management
Safe and appropriate
use of products

Further enhance capability to secure patient safety andproduct quality as well as optimizing customer interaction for maximizing value for patients.

Environmental Sustainability
Key Issues
Reduction of environmental
burdenOur Commitments by FY2025

Establish a more sustainable andresilient value chain.

• Fostering a Culture of Quality through leadershipcommitment, employee engagement and patient
centric mindset.
• Evolving customer experience with coordinatedomnichannel engagement leveraging digital.

Ensure patient safety and product quality
by fostering a Culture of Quality andby evolving customer experience.

Reduce the environmental burden of Astellas’ business, address climate change and energy issues,
and respond to environmental sustainability.

Mid-term Priorities for Astellas
Reduce greenhouse gas emissions toward a goalconsistent with the Paris Agreement’s and achieve
net zero emissions by 2050.

Initiatives

Our Commitments by FY2025• Enhancing energy efficiency and shifting to renewableenergy sources such as solar and wind power, reducing
the carbon footprint of the supply chain.

Achieve by FY2025 the amount of reasonablereduction of greenhouse gas emissions target** GHG emission reduction targets by FY2030• Scope 1+2: 63% reduction (base year: FY2015)• Scope 3: 37.5% reduction (base year: FY2015)

Climate change and energy

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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.

With “outcomes that matter to patients,” Astellas is committed beyond the safety

Common Definition ofand efficacy of treatments. We seek to understand and optimize our products,

VALUE*and their subsequent use, to maximize improvements in quality of life (QOL)
and to minimize the burdens they create.

Outcomes
VALUE=For “costs to the healthcare system of delivering those outcomes,” we arethat matter to patients

looking at the individual costs borne by the patient, the healthcare costs borne

Costby insurance companies and public institutions, as well as the indirect costs andto the healthcare system ofdelivering those outcomesburdens imposed on the patient’s family and care givers.

VALUE

Patients

OF PATIENTSFor 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 acrosssociety, 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.

Healthcare
ProviderPayer

We believe that by placing this concept at the core of our business andadapting it to all divisions and regions, Astellas will be able to make a greater

Caregivercontribution 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

Value provided• Improving people’s quality of life and enhancing
community healthcare by creating innovative new
medicines• Find new knowledge from research data to create
scientific innovation• Improving technology level, development ofhealthcare industry• Recommendations for better healthcare policy

Academia, research
institutions

Publicadministration• Applying cutting-edge research findings to
medical care
• Training researchers• Participating in economic and industry associationsand various external initiatives

Value provided

Value provided• Social contribution activities and donations• Fulfilling unmet medical needs by creating
innovative medicines and medical
solutions• Environmental conservation

Patients and theirfamilies, healthcare
professionals• Job creation• Increasing awareness and understanding of
diseases and medical care

Local community

Examples of activities• Open Forum targeting general public(twice/FY2022)• Providing information on safety and efficacy• Improving Access to Health (ATH)• Ensuring a continuous stable supply ofinvestigational drugs and commercialized
products• Support for patient organizations• Cross Talk Forum (once/FY2022)• Reducing the burden on families and theentire healthcare system
Dialogue results• Medical seminars for patients and theirfamilies (twice, FY2022)

Value provided• Opportunities and places for self-development andself-actualization• Places, co-workers, and resources for solving social issues
and contributing to the health of people around the world

Shareholders andinvestors

Employees• Job satisfaction

Business
partners• Compensation• Healthy organizational culture• Ask Me Anything* (21 times/FY2022)• Live Stream (four times/FY2022)* Ask Me Anything: Large interactive sessions designed to promote
two-way communication between management and all.

• Sustainable enhancement of enterprise value• Stable shareholder dividends• Timely and appropriate information disclosure• Good working environment (work style reforms, promotionof remote work, etc.)

Dialogue results

Value provided

Value provided• Engagement with investors
Dialogue results• IR meetings with securities analysts and institutional investors (approx. 260 times/FY2022,
including 20 ESG meetings)• Earnings calls and IR events (product-related
meetings, R&D meetings, sustainability meetings,etc.) (10 times/FY2022)• Driving innovation and creating new value throughcollaborations with Astellas and integration of capabilities

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Value Creation

Value Creation Story

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for Value Creation

Corporate Data

Corporate Strategic
Plan for Value Creation

CONTENTS
Corporate Strategic Plan for Value Creation
Top Management
Progress of Corporate Strategic Plan

Special Feature I

28

Roundtable: An Evolving Organizational Culture-The Organizational Health Goals at Work-

Corporate Strategic Plan 2021

29

Interview with Chief Strategy Officer

30

Financial Strategy

33

People Strategy

Interview with Chief People Officer andChief Ethics & Compliance Officer

R&D Strategy

27

38

People and Organization for Innovation

43

Engagement, Diversity, Equity and Inclusion

47

53

Areas of Interest

54

DX Strategy

59

Sustainability Strategy

Commercial Strategy

Interview with Chief Commercial Officer

48

Special Feature II

36

Interview with Chief Medical Officer

VEOZAH: New nonhormonal treatment option
for VMS due to menopause

49

Main Product Sales

52

26

Interview with the Head of
the Sustainability Division

61

Initiatives for Contribution to Sustainability

62

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Top Management

7

6

4
3

5

2
1
8

1 Naoki Okamura

5 Hideki Shima

Representative Director,
President and Chief
Executive Officer (CEO)

Chief Manufacturing
Officer (CMfgO)

2 Katsuyoshi Sugita

6 Claus Zieler

Representative Director,
Executive Vice President,

Chief Commercial
Officer (CCO)

Chief People Officer andChief Ethics & Compliance
Officer (CPO & CECO)

27

3 Yoshitsugu Shitaka

7 Adam Pearson

Chief Scientific Officer(CScO)

Chief Strategy Officer(CStO)

4 Tadaaki Taniguchi

8 Catherine Levitt

Chief Medical Officer(CMO)

General Counsel (GC)Interview with Chief
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Progress of Corporate Strategic Plan
Financial Guidance

FY2015–FY2017

Corporate
Strategic Plan
2015

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+1.4%*1

Core operating profit

CAGR that exceeds revenue+7.5%*1

R&D investment

Higher than 17% of revenue

16–17% of revenue / improvement of cost structureCore EPSCAGR that exceeds CAGR of core operating profit+13.2%*: Achieved EPS CAGR exceeding CAGR of core OP along with enhancement of capital efficiency

DOE

6% or more

5.7%: Result of FY2017

Major Initiatives and Accomplishments
1 Maximizing Product VALUE and Operational Excellence

FY2018-FY2020

Corporate
Strategic Plan2018

FY2021–FY2025

Corporate
Strategic Plan
2021

3 Developing Rx+ Programs• Sales of XTANDI and mirabegron steadily increased• Six post-PoC projects: Achieved important milestones as planned• Prioritize sales promotion expenses and promote global procurement efficiencies (approx. ¥50.0 billion*2
profit improvement)

2 Evolving How We Create VALUE: With the Focus Area Approach• Enhanced utilization of innovative platforms among multiple Primary Focuses and produced multiple
promising projects• Strengthened capabilities through collaborations and acquisitions• Achieved partnerships with various technologies from different fields• Successfully advanced multiple programs toward commercialization

Financial Guidance
Revenue

FY2017 level (¥1,300.3 billion)¥1,249.5 billion

Not achieved

R&D investment

More than ¥200.0 billion¥224.5 billion

Achieved

Core operating profit

Core Operating Profit margin 20%

20.1%

Achieved

Core EPS

Exceed FY2017 level (¥100.64)¥113.03

Achieved

Performance Goals

Strategic Goals

Organizational Health Goals

Aim to become a company with a Market Cap valued at more than
¥7 trillion in FY2025 by achieving

1 Enable patients to achieve better outcomes

1 Brave ideas pursue ambitious outcomes2 Translate innovative science into proven VALUE

2 Talent and leadership thrives

1 Revenue: XTANDI and Strategic products*3 sales≥ ¥1.2 trillion in FY2025

3 Advance the Rx+ Business3 We excel as One Astellas

4 Deepen our engagement in sustainability• Fostering a corporate culture that aims to achieve ambitious goals

2 Pipeline Value: Focus Area projects expected sales≥ ¥0.5 trillion in FY2030• Significantly improving our execution capabilities

3 Core Operating Profit Margin: ≥ 30% in FY2025
Performance Goals are set to measure successful execution of
CSP2021 and indicate our ambitious goals in financial terms.
We set goals from three 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.

We have four Strategic Goals, and the first three goals focus on“what’s next” following our efforts in CSP2018. SG4 is newly
introduced. We considered that it is needed to set sustainabilityrelated thinking at the core of our business. We aim at solvingsocial issues through our core business. Our sustainability is thesustainability for both society and Astellas.

28

We have newly set Organizational Health Goals in CSP2021.
We have adopted three goals. We recognized that we need totransform our organization and create the best internal
environment to drive innovation and maximize our execution.

*1 CAGR for 3 years starting from FY2014 results *2 Cumulative total of FY2018-FY2020*3 PADCEV, XOSPATA, zolbetuximab, Evrenzo, VEOZAH, AT132

Interview with Chief
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Corporate Strategic Plan 2021
Progress of Strategic Goals
Goals

Major Initiatives and Accomplishments in FY2022*1

Strategic Goal 1:
Enable patients to achieve better outcomes• XTANDI: met primary endpoint in Phase 3 EMBARK study in non-metastatic castration sensitive prostate cancer (March 2023), supplemental New Drug Application (sNDA)
accepted in US (August 2023)• PADCEV: granted accelerated approval in US for additional indication of first-line therapy for patients with locally advanced or metastatic urothelial cancer who are not eligible toreceive cisplatin-containing chemotherapy (April 2023)• VEOZAH (fezolinetant): Marketing Authorization Application (MAA) accepted in Europe (September 2022) and approval obtained in US (May 2023)• Zolbetuximab: NDA/Biologics License Application (BLA)/MAA accepted in Japan (June 2023), US, Europe and China (July 2023)• IZERVAY (avacincaptad pegol): approval obtained in US (August 2023), MAA accepted in Europe (August 2023)

Strategic Goal 2:
Translate innovative science into proven VALUE• In FY2022, seven new drug candidates discovered through results of research• In FY2022, two programs entered clinical stage (both in Primary Focus Immuno-Oncology)• Selected Targeted Protein Degradation as new Primary Focus• Deployed new R&D operating model with view to accelerating PoC*2 achievement

Strategic Goal 3:
Advance the Rx+ business

Strategic Goal 4:
Deepen our engagement in sustainability

Relationship toMaterial Issues

➊

➊

➋

➌

➍

➎

➏

➋

➌

• Entered into an exclusive US commercialization agreement with Stryker for pudexacianinium chloride (ASP5354, a novel surgical imaging agent)• Commenced sales pilot of Holter electrocardiograph, EG Holter™
• Entered into agreement with Roche Diabetes Care Japan for commercialization of blood glucose monitoring system as combined medical product with BlueStar digital healthsolution for diabetes self-management➊➋• Established Sustainability Direction as guide to addressing nine material issues and two key issues related to the environment sustainability, incorporating medium-term priorities,
initiatives, and commitments by FY2025• Visualized the impact of Astellas’ Access to Health (ATH) initiative by creating ATH metric with number of patients who received VALUE delivered by Astellas throughcomprehensive Access to Medicine mechanism• Declared Net Zero GHG emissions by 2050, received accreditation from the Science Based Targets (SBT) initiative for its 2030 GHG emission reduction targets, and established a
GHG emissions reduction strategy to realize our commitment to climate change➊ – 11➍

Progress of Organizational Health Goals
Major Initiatives and Accomplishments in FY2022*1

Relationship toMaterial Issues• Driving the development of a feedback culture through the execution of forums and feedback tools that focused on improving psychological safety and innovation. Concentrated
on talent development with the launch of simplified competencies, talent toolkit, improved succession planning and inaugural Female Connect & Lift program*3• Driving a flatter organization with less management hierarchy to promote rapid decision-making and strategic transformation into an innovative organization

➒

Goals
1. Brave ideas pursue ambitious outcomes
2. Talent and leadership thrives
3. We excel as one Astellas*1 Some information includes after April 2023 *2 PoC: Proof of Concept (key clinical data supporting a decision to initiate late-stage development) *3 Female Connect & Lift program: program for the development of female leaders

Key Issues and Materiality
Astellas will evolve sustainability for society and Astellas by addressing the key social issues and materiality➊ Access to Health ➋ Fulfilling unmet medical needs by creating novel healthcare solutions ➌ Transformative treatment through innovative therapeutic methods ➍ Value-based pricing ➎ Product quality assurance and product safety➏ Safe and appropriate use of products ➐ Compliance and ethical business practices ➑ Responsible supply chain management ➒ Talent and organizational culture for realizing innovation ➓ Reduction of environmental burden 11 Climate change and energy

29Interview with Chief
Executive Officer

Astellas Pharma Inc. Integrated Report 2023

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Value Creation

Value Creation Story

Strengthen Foundation
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Corporate Data

Interview with Chief Strategy Officer
I experienced how confusing healthcare systems can be, in part because patients often
have multiple diseases. I also found that side effects are really important—I stopped one
very efficacious drug because of the side effects. Even for life-saving medicines, it’s a real
trade-off. I also learned how kind people are. I got hundreds of messages and many people
kept checking in. Several of them were on chemotherapy who were in a far worse condition than me, but they still wanted to support me.
But I suppose the biggest take away is that what we do in a pharmaceutical company is
so important and makes such a difference. So many patients rely totally on medicines
which companies like ours have a role in producing, to control their disease.

My recent experience as a patient
gives me even more motivation to
help us make the right choices tohave a big impact on patients
Chief Strategy Officer (CStO)

Adam Pearson

Q

Q

Could you tell us about your recent medical issues andwhat you learned from them?

How is strategy developed and executed within Astellas andwhat is your role within that process?

As CStO, I am in a position to help build the future of this dynamic company,
by creating the frame in which strategy can develop and evolve in a coherent
way within the context of our financial constraints and goals.

Ultimately, I learned how important what we do in a pharmaceuticalcompany is and how much difference it makes.
Last June in a regular medical checkup in Japan, I had some unusual blood test results
which led to a diagnosis of a kidney condition. A further test showed a possible cause ofthis might be AL amyloidosis, a relatively rare bone marrow condition that is not curable.
I returned to the UK for tests that confirmed the diagnosis. I was fortunate that they foundthe disease at an early stage and that several chemotherapy treatments are available. I've
responded quite well to treatments.
I'm fully back at work now and hope to continue to work without too much of a disease
burden for a while. It’s the first time that I or anyone I’m close to has had such a serious
disease. So, this experience has brought me a lot closer to the healthcare system in the UK
and Japan, especially oncology. I gained perspective both as a patient myself and as amember of various patient groups: Living with uncertainty all the time, the need for
information and explanation, how thankful you are when drugs are available to treat thedisease—but also how difficult it can be when they are not.

I’ve worked at Astellas for nearly 20 years, and sometimes I’ve thought “why do we do that?”or “why not this?” Now I have a greater chance to understand why some decisions are madeand also influence those in order to make an impact. My recent experience as a patient givesme even more motivation to help us make the right choices to have a big impact on patients.
The CStO area is all about building our future, with functions like corporate strategy,
patient centricity, business development, and the Primary Focus Leads all focusing around
our long-term direction and how we collectively get there. It also covers Digital, Analytics
and Technology*, which will help us to leverage these technologies to create VALUE in new
ways. And it covers our new non-pharma businesses, including Rx+ and bioelectronics.
Creating and executing strategy is not something a single person can or should do on theirown. In order for the strategy to be well informed, and well executed, it needs leaders from acrossthe business — from Top Management to Subject Matter Experts, to be part of the discussions.
My role is to create the conditions and frame in which the right strategy can be developed andevolved, from Corporate to R&D and the portfolio to DX (Digital transformation) Strategy and* At the time of the interview conducted in April 2023.

30

Astellas Pharma Inc. Integrated Report 2023

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Interview with Chief Strategy Officer
functional strategies across the value chain. I need to make sure that it all hangs together
across these areas. I also need to ensure that our strategy reflects not only our long-term
aspirations but also our current financial context. Another aspect of my role is to make sure that
we set up to implement strategy well—that we have the right capabilities, but also the rightenvironment, talent, and culture which collectively makes up our organizational health.
Astellas strives to be a VALUE-driven life science innovator, seeking to create and deliver
VALUE for patients using innovative science. Astellas considers VALUE to be a reflection of
the outcomes patients receive from our products within the context of the costs to thehealthcare system for delivering those outcomes. In this way, we’re looking to make bigchanges to the treatment of patients, with R&D focusing on the linkages between modalities
and biologies that will create platforms to generate innovative drugs. The Corporate Strategic
Plan we launched just over two years ago, CSP2021, set out specific strategies for achieving
our overall goal of bringing innovation to patients, in terms of how we provide VALUE topatients, how we create VALUE in our R&D, and how we create VALUE outside the prescription
pharmaceutical business. It also set goals for our organizational health to enable us to beeffective in executing our strategies.
CSP2021 also includes financial performance goals both to provide a clear set of internal
milestones for achieving sustainable financial performance as well as to communicate tooutside investors and other stakeholders what we believe we can achieve. This is a goodcompass for us, guiding us in making choices and setting priorities to achieve our goals.

Q

new thinking to how we execute these within and across the business. This will be myfirst priority.
The second involves the acquisition and integration of other companies to support the
CSP goals. For instance, we acquired Iveric Bio, which is a fantastic opportunity for Astellas
to serve patients in the field of ophthalmology who have some serious unmet needs, andare exploring other acquisitions.
My third priority is the integration of our digital analytics and technology function, andsupporting our new Chief Digital Officer as they start their role. I want to put digital analyticaltechnologies, data, and information technologies at the heart of VALUE creation in the company,
making sure that we not only make the right choices as to how we invest in technology,
but also improve our capabilities to adopt technology.
My fourth priority is to ensure that we drive simplification of our business to support
operational effectiveness. We have evolved policies and procedures and ways of working
with good intent and purpose, but it has become harder for everyone, especially those working
directly to bring our drugs to patients, to get things done quickly and efficiently. It is at the
top of my agenda to ensure that we tackle this top down, particularly with the corporate
functions that govern a lot of processes and policies.
Finally, my fifth priority is to support the new R&D operating model, ensuring that it iseffective in progressing and accelerating our assets through to proof of concept and beyond.

Q

What are your priorities for FY2023?

The market is interested in the growth story for Astellas after
the XTANDI loss of exclusivity. How would you achieve that growth?

Looking beyond FY2025, we will address challenges in the early stage
pipeline in part by bringing in outside innovation at different stages.

This year at least, I am focusing on five priorities.

CSP2021 set out ambitious performance goals for the business up to FY2025, but also
implied goals beyond that. Critical to this was the launch of new indications of PADCEV andthe launch of VEOZAH, zolbetuximab, and AT132. We also needed a number of early stage
projects to reach proof of concept and enter late stage development. As far as the latestage assets are concerned, we are mostly satisfied with their growth and with the potential
for assets not yet launched.

It is important within my role and indeed across our Management Team to respond tointernal and external changes as and where appropriate. However right now, I have five
big priorities.
Astellas is in a unique situation in that we have a new CEO and a new Top Management
team. This means we can provide a fresh perspective on our selected strategies and bring31

Astellas Pharma Inc. Integrated Report 2023

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In terms of Critical Enablers, we’ve made a lot of progress in the areas of VALUE Gene andpatient centricity. In fact, we’ve been able to pilot new VALUE Gene capabilities and embed theminto the business as business as usual. This has given us the space to identify new differentiating
capabilities to pilot. In patient centricity, we’re getting a lot of good feedback from R&D about its
ability to provide patient insight that informs our development areas and programs. The other
Critical Enabler is Digital Transformation. Here, there have been some individual successes, but asa whole, we want the change to be broader and more value-creating.
The last area is Performance Goals. We knew the financial trajectory was never going to belinear—a lot of the improvement in growth and profitability has come in the last two years. So
it’s been hard to show as much progress as we would have liked. Having said that, we areresponding to the challenges we have faced, particularly in the early stage pipeline, withacquisitions like Iveric Bio that address the post-FY2025 financial trajectory—and even preFY2025 performance—and bring in stronger cash flows to fund sustainable R&D investment.
So we are making progress, but there is much work to do. Despite a tough external
environment, our launched products are growing well and providing VALUE to patients.
Our innovative pipeline is progressing slower than we might have anticipated, but we aremaking improvements to accelerate progress. Our CSP2021 is providing the roadmap to our
VISION. With the new launches we have ahead of us, I am optimistic we will reach our goals.

We haven’t had the success we wanted in the early stage pipeline. That’s somethingthat’s always hard to control, especially when pursuing ambitious goals in new, innovative
areas. We’re addressing both by building our own capabilities and by bringing innovation infrom outside like Iveric Bio, that will support our financial goals and also build our presence
and knowledge in the strategic franchise of ophthalmology, where much of our researchand early stage development is. We will continue to look at other opportunities to bringoutside innovation into the company, at different stages, to reach our growth ambitions
after the XTANDI loss of exclusivity.

Q

Midway through CSP2021, what has Astellas achieved so far andwhat is to come?

We’ve made good progress with many of our Strategic Goals,
but still have work to do on our Organizational Health Goals andPerformance Goals.
The strategic ambitions we laid out have helped drive programs of change or development,
and we are now seeing new ways of working or capabilities being implemented—for example,
our R&D operating model built around the Primary Focuses, or new ways of combining different
types of evidence as we develop new drugs. We have made steps forward in collaborating
across different functions to support and communicate with our customers and stakeholders.
Our late-stage portfolio and marketed products are largely delivering what we hoped
they would, and we have two major Rx+ programs heading into the data generation andcommercialization phase. We have also reshaped our Sustainability strategy.
As for our Organizational Health Goals, there has been some positive change but we still
have some way to go. I think collaboration has improved in critical areas, particularly
among our functions developing and commercializing our drugs. We are gradually investingin and improving our approach to talent development, but there is still work to do. On creatinga brave, open innovative culture, I think the message is out there and has been understood, but
we are still working out how to really make it come alive—trying to encourage proactive
sharing of ideas, risks and alternative views.

32Astellas Pharma Inc. Integrated Report 2023

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Financial Strategy
1. Basic Policy

PADCEV growth and launch readiness for VEOZAH (fezolinetant), such that sales promotion
expenses rose YoY. Overall, we were able to rein in costs according to plan while also making

Astellas is committed to delivering VALUE for patients around the world, through corporate

the necessary investments, maintaining control over SG&A costs throughout the year.

activities that put emphasis on generating stable cash flow and enhancing shareholder value

R&D expenses increased by 12.2% YoY to 276.1 billion yen but rose only 1.1% YoY when forex(in short, market capitalization). The basic policy underpinning our financial strategy is to enhance

effects are excluded. The main factor behind the increase in R&D expenses was the booking ofenterprise value by achieving sustained growth in profit, through a well-balanced allocation of the

one-time costs for using a priority review voucher in Q1 to expedite approval in the US for

cash thus generated between business investments geared toward future growth and returning

VEOZAH. In real terms (excluding this one-time cost), R&D expenses decreased YoY.

profit to shareholders.

As a result, core operating profit increased 17.2% YoY to 286.9 billion yen.

One of the Performance Goals of our current Corporate Strategic Plan 2021 (CSP2021) is toachieve a more than 30% core operating profit margin in FY2025. While from an investment
efficiency standpoint we also see a need in future to monitor ROIC*1 and ROE*2 as two indicesmeasuring the profitability of invested capital, the focus for now is on achieving our core operating(billion yen)

FY2021

FY2022

ChangeChange (%)

FY2022
FCST*3

Achievement

Revenue

1,296.2

1,518.6+222.5+17.2%

1,529.0

99.3%

253.0

288.4

+35.3

+14.0%

19.5%

19.0%

–0.5 ppt

Cost of sales

profit margin target as we strive to build a financial structure that consistently generates profit.

% of revenue

We also emphasize accountability and sustainability in our pursuit of increased enterprise

548.8

630.3

+81.4

+14.8%

642.0

98.2%

value. Our policy is to expand information disclosure with a view both to enhancing enterprise

SG&A expenses
US XTANDI co-pro fee

139.3

175.5

+36.2

+26.0%

186.0

94.3%

value by earning the trust of shareholders and investors, and securing the understanding of

SG&A excl. the above

409.5

454.8

+45.3

+11.1%

456.0

99.7%

278.0

99.3%

290.0

98.9%

97.1%

other stakeholders.
*1 Abbreviation for Return on Invested Capital; a financial metric that aims to measure the percentage return that a company earns on invested capital.
*2 Abbreviation for Return on Equity; a financial metric for measuring the profits generated using shareholders’ equity.

R&D expenses

246.0

276.1

+30.1

+12.2%

Amortization of intangible
assets

28.3

38.4

+10.2

+35.9%

Gain on divestiture ofintangible assets

24.2

0.2

–24.0

–99.1%

244.7

286.9

+42.2

+17.2%

2. Progress of Corporate Strategic Plan 2021

Core operating profit

Review of FY2022<Full basis>
Other income

15.3

3.6

–11.6

–76.1%

Other expenses

104.3

157.5

+53.2

+51.0%

the prostate cancer drug XTANDI, urothelial cancer drug PADCEV, and acute myeloid leukemia

Operating profit

155.7

133.0

–22.7

–14.6%

137.0

drug XOSPATA.

Profit before tax

156.9

132.4

–24.5

–15.6%

135.0

98.0%

Profit

124.1

98.7

–25.4

–20.4%

105.0

94.0%

Revenue increased 17.2% YoY to 1,518.6 billion yen in FY2022, underpinned by growth in sales of

SG&A expenses, excluding co-promotion fees for XTANDI in the US, increased by 11.1% YoY
to 454.8 billion yen, but decreased by 1.3% or 5.1 billion yen YoY when the impact of forex is*3 FY22 FCST were announced in Oct 2022, provided that full basis is the revised forecast announced on April 11, 2023.

excluded. Not only did personnel expenses fall amid global optimization of commercial
personnel, but also Astellas strove to reduce sales promotion costs for mature products suchas the overactive bladder treatment mirabegron. At the same time, we invested actively in33

Astellas Pharma Inc. Integrated Report 2023

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Toward Achievement of CSP2021 (Image)

Initiatives for FY2023 Onward
We regard FY2023 as a turning point for CSP2021, marking a key inflexion point ensuring growth• Continue commitment to Corporate Strategic Plan 2021

from FY2024 onward. We have high expectations that VEOZAH will become a blockbuster and• FY2023 is the turning point to ensure growth from FY2024 onwards

to that end have assigned the drug greater investment priority, spending proactively with a

Revenueview to realizing rapid market penetration and expanding sales after launch. In the case ofCore OPPADCEV, we hope the indication of first-line therapy for metastatic urothelial cancer will become

Sustainablegrowth after
LOE of XTANDI

a major growth driver. We expect sales expansion in the US as well as progress in development
toward global approval filings. With zolbetuximab, we will proceed with global submissions

VEOZAH

while at the same time making investments supporting market penetration after launch. In thisPADCEVmanner, we will target sales expansion with new products and new indications while simultaneously undertaking investments in creating the optimal cost structure for the future.

zolbetuximab

To achieve a core operating profit margin of 30% in FY2025, we will maintain a policy ofapprox.
25%

CSP2021 target
more than 30%

Post-PoC PF
portfolio

19%

keeping SG&A expenses flat in terms of the absolute amount, while acknowledging that SG&A

Optimization of cost structure

expenses in fact could increase in tandem with revenue as we make the optimal investments for

FY2023prioritizing growth. We seek the most efficient balance as we look to realize sustained growth

FY2024FY2025

while also maximizing enterprise value.
As we pursue cost structure optimization, though, we will continue to curtail any excessive*1 The impact of the acquisition of
Iveric Bio is not factored into theoutlook for FY2023 and beyond.
*2 PoC: Proof of concept*3 PF: Primary Focus*4 LOE: Loss of exclusivity

growth in SG&A expenses. While we already have had a degree of success in optimizing the cost

3. Capital Allocation

structure, there remain opportunities for efficiency gains. In the process of transforming

In our capital allocation policy at Astellas, our top priority is investment for business growth as

our organization from a regionally segmented organization into one governed by function,a key plank in our policy of grasping opportunities to maximize product value while adapting

the organization ended up gaining more layers. Against this backdrop, we continue to advanceto constantly changing circumstances. Our intention is to raise the dividend level throughout

organizational flattening while simplifying procedures and eliminating duplication of effort,

the period covered by CSP2021, in line with our profit/cash flow plan and actual performance.

enhancing the organization’s decision-making speed as well as optimizing the cost structure

When excess cash is available, we will execute share buybacks flexibly.

through productivity and efficiency gains. In this manner, by further growing sales of highmargin products while persisting with efforts toward cost structure optimization, we seek toInvestment for Business Growth

vastly improve the ratio of SG&A expenses to revenue.

As detailed above in “Initiatives for FY2023 Onward,” by “investment for business growth”
we mean actively engaging in investment geared toward future growth. One of our options inthis respect is to invest in other companies. In such cases, we eschew investment in companies

34Astellas Pharma Inc. Integrated Report 2023

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with established businesses in favor of investing—by means such as M&A—in companies

The 800 billion yen in funding for the Iveric Bio acquisition uses debt financing. With ouroffering cutting-edge technologies and programs. Our basic policy is to retain a flexible

strong cash flow, we expect to repay this debt within the next five to seven years. If there is cash

approach to undertaking M&A should the opportunity arise.

left over after debt repayments, we will look at either paying down the debt early or returning

In July 2023, Astellas acquired Iveric Bio, a biopharmaceutical company with expertise in thethe excess cash to shareholders, depending on the circumstances.

ophthalmology field. Iveric Bio has promising programs including IZERVAY*1 (avacincaptad pegol)

Investment for Business Growth

for the treatment of Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration(AMD), and capabilities across the entire value chain in the ophthalmology field. We believe that

① Top priority is investment

this acquisition will enable Astellas to deliver greater VALUE to patients with ocular diseases at② Raise dividend level aligned

for business growthhigh risk of blindness.”
As this acquisition involved a large outlay of approximately 800 billion yen, our plan for now is
to focus on integrating Iveric Bio’s operations and shifting its business into high gear. In enacting③ Flexibly execute sharewith profit / cash flow plan
and actual performancethroughout CSP2021 periodbuyback by excess cash

Aiming for higher level of dividends increase during CSP2021 aligned with the robust profit growth forecast

our current R&D strategy, though, we will continue employing M&A and other means to invest in
the acquisition of necessary technologies, platforms, and capabilities, in line with our basic policy.

Trend of Core OP and dividends

We will make further investments in the fields of cell and gene therapies, as we consider theseCore OP (billion yen)technologies critical to Astellas’ future growth.

600*1 FDA approval obtained in US (Aug 2023), MAA accepted by EMA in Europe (Aug 2023).

Dividends (yen)
100

500

80

400

Shareholder Returns

60

300

Astellas also will continue working aggressively toward improving returns to shareholders.

200

We strive to increase dividend payments stably and continuously based on medium- to100

long-term growth in consolidated profits. Further, we will flexibly buy back shares when excess

0

cash is available, with a view to increasing capital efficiency and returning more profit to14
FY2005

Core OP (left)

shareholders. In anticipation of medium- and long-term growth in FY2024 and beyond, we are

16

22
FY200724

25
FY200925

25
FY201126

27
FY201330

32
FY201534

36

FY201738

40

FY2019Dividends (right)*2 Prior to FY2012, operating profit is in accordance with J-GAAP.
*3 The impact of the acquisition of Iveric Bio is not factored into the outlook for FY2023 and beyond.

planning a 10 yen dividend increase to 70 yen per share for FY2023.

35

42

50

60

40

70

20
FY2021

FY2023

FY20250Interview with Chief
Executive Officer

Astellas Pharma Inc. Integrated Report 2023

Corporate Strategic Plan for
Value Creation

Value Creation Story

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Corporate Data

People Strategy Interview with Chief People Officer and Chief Ethics & Compliance Officer
As work styles diversify, we seek to accelerateinnovation by assembling the best possible
team with a strong growth mindset,
comprising individuals from both insideand outside Astellas.

approach, we have faced some resistance. Concerns have been raised, suggesting that flattening theorganization might lead to a reduction in managerial positions. However, personally, I do not believethat managerial experience is an indispensable aspect of one’s career trajectory. I firmly believe that
individuals should have the autonomy to choose between a specialist or managerial career pathbased on their preferences and skills. To me, the distinction between the two paths is inconsequential.
What truly matters is ensuring that the right individuals are involved whenever significant tasks arise.
Transforming an organization’s culture is undoubtedly a challenging endeavor, but we have madesignificant progress by utilizing actual data to develop a comprehensive understanding of theorganizational issues that existed before the reforms took place in Astellas.
I have been a member of the Top Management team for some time now, and since myappointment as Representative Director and Executive Vice President, there have been no
significant changes for me in the working environment. We live in an era that demands both anunderstanding of human capital management and a proactive approach to intervene inmanagement matters. I believe my appointment reflects Astellas’ recognition of the necessity toactively pursue our OHGs in order to drive innovation.

Katsuyoshi Sugita
Representative Director, Executive Vice President Senmu Tantou-Yakuin
Chief People Officer and Chief Ethics & Compliance Officer (CPO & CECO)Q

How did you contribute to Corporate Strategic Plan 2021 (CSP2021) as CPO &CECO, and how will that change with your new appointment as
Representative Director, Executive Vice President?

This fiscal year, Astellas made significant strides toward achieving our Organizational
Health Goals (OHGs), and as Executive Vice President, I am committed to accelerating
innovation at Astellas.

Q

Building an organizational culture that facilitates innovation is not an endeavor that delivers results
swiftly. However, in this third year of CSP2021, significant changes have been observed in ourorganizational culture, particularly in our internal meetings involving Top Management. We willcontinue to foster an environment where ideas are freely proposed and encouraged during
discussions. Similarly, our decision-making meetings have transformed into spaces that promote
constructive debate, allowing participants to express frank and, at times, directly conflicting opinions.
I believe that this approach has been instrumental in enabling us to make appropriate decisions
while embracing intelligent risk-taking. Furthermore, I have noticed a significant increase in thenumber of employees taking proactive initiatives. Recent data shows a higher rate of employees
voluntarily moving to different functions in response to internal job postings, fostering greater
employment mobility within Astellas. This not only cultivates a proactive work environment but also
ensures the right person in the right position.
In our quest to foster innovation, we are working on transforming our organizational culture andmaking the organization flatter to facilitate quicker decision-making. While implementing thisJapanese companies are now required to enhance their human capital disclosure.
Could you please provide information about Astellas disclosure policy as a global
company and provide an overview of the measures being implemented?

At Astellas, we understand the vital role of human capital disclosure, which extends far
beyond presenting mere numbers. Instead, we aim to integrate a storytelling approachthat aligns with our corporate strategy. By doing so, we can offer investors a moreinsightful and holistic view of our workforce and its impact on our organization. To thisend, we provide detailed results from our global engagement survey which allows us
to comprehend the sentiments and perspectives from our employees companywide.
Incorporating human capital in management decisions is critical at present, and this belief has beensteadfast throughout my career. I believe that management decisions must be grounded not only inqualitative information, but also in quantitative data, akin to the approach taken in sales or marketing
decisions. As Astellas has a global human capital-related database, we have easy access to such vitaldata, and we are committed to further enhancing transparency going forward.

36

Astellas Pharma Inc. Integrated Report 2023

Interview with Chief
Executive Officer

Corporate Strategic Plan for
Value Creation

Value Creation Story

Strengthen Foundation
for Value Creation

Corporate Data

People Strategy Interview with Chief People Officer and Chief Ethics & Compliance OfficerQ

I believe that human capital disclosure should not be limited to merely quoting numbers.
Rather, it is important for human capital disclosure to tie in with the story telling approach following
our corporate strategy. Astellas has a clear aspiration outlined in CSP2021 and our OHGs. To monitor
the progress of our journey, we carefully identify the appropriate KPIs.
Astellas utilizes an essential indicator, the global engagement survey score for all employees,
to assess improvement opportunities and monitor progress. Instead of evaluating the score solely
based on overall results, we analyze it in relation to each target of the OHGs and by functions.
This approach allows us to identify specific areas for improvement. For instance, a team with a highscore related to white space* doesn’t simply have extra time; it may be due to the leader’s implementation of unique measures or effective work-life balance achieved through team discussions.
Rolling out these successful practices horizontally to other functions holds great importance.

In an ever-changing society, Astellas aspires to be a dynamic company that not only
fosters continuous growth and innovation, but also demonstrates the foresight andadaptability to navigate these shifts with flexibility.
Transforming the organization into one that fosters continuous innovation requires a companywide effort, involving not only the human resources (HR) division but every division. It is crucial
to establish a framework that empowers managers in each division to independently ideate
and implement their innovative ideas, maximizing the need for constant involvement from HR.
To facilitate this, the development of supportive systems and tools becomes paramount.
The HR data dashboard currently in use shows promise but has room for further improvements
to enhance its user-friendliness. To nurture a culture of innovation throughout Astellas, we arecommitted to developing the skills and mindset of our managers themselves with the necessary training and resources.
To better deliver on CSP2021, each of us must focus on our own priorities and dedicate moretime to execution. I have several ideas for allocating more time to planning, discussions, andreviews, including a clearer division of periods for planning and execution.
In addition, I believe that lifelong learning will increasingly become a crucial aspect for our
employees. By continually pursuing further learning and acquiring new skills, both within ourinternal networks and externally, our employees can thrive in a world that demands continuous
growth and adaptation. In fact, we embrace the idea of employees exploring side jobs outside
Astellas to gain valuable experience. We aim for Astellas to become the preferred choice forexternal individuals seeking side job opportunities. To drive innovation, we actively encouragesuch practices and provide a supportive platform for lifelong learning. By assembling a teamwith a strong growth mindset, empowered by their diverse experiences, we strive to accelerateinnovation and drive Astellas forward with unwavering momentum.
In a world where change is accelerating, we have a strong sense of mission and will continue
to ambitiously work toward the OHGs set by CSP2021. We invite you to look forward to Astellas’
endeavors in continuously creating innovation.

* White space is defined as “having the time, tools, and expertise to think of new ideas.” It is having the necessary resources to be innovative.

Q

Lastly, please tell us what you are currently focusing on and share yourmessage for stakeholders.

Please describe how Astellas secures and develops talent in this era ofcross-border and cross-industry competition for talent.

In recruiting and retaining talent, we place great emphasis on diversity and makedecisions based on each individual’s career aspirations and potential.
It is essential not only to recruit personnel but also to retain them. While employment conditions
are crucial, we also believe that it is necessary to foster a deep understanding and respect foreach individual’s career aspirations and potential. In this regard, the role of people in management and oversight positions is critical. When it comes to recruitment, I recall that when filling asenior position in a particular division, we posted the role globally to attract internal and external
candidates, resulting in an impressive array of submissions. Looking ahead, we are committed tomaintaining this creative approach in recruiting top talent.
We have invested a lot of effort into succession planning. We have a system in place that clearlysets out succession plans and identifies candidates for each position, and in this respect, I believe
Astellas compares very favorably with global peers. On the other hand, I still feel there is an
opportunity for us to improve. For example, we must be sensitive to unconscious bias and make surethat we are choosing the best people drawn from a diverse candidate pool. My goal is to bring about
improvement in this respect by promoting greater awareness of diversity.

37Interview with Chief
Executive Officer

Astellas Pharma Inc. Integrated Report 2023

Corporate Strategic Plan for
Value Creation

Value Creation Story

Strengthen Foundation
for Value Creation

Corporate Data

Special Feature I

Roundtable: An Evolving Organizational Culture —The Organizational Health Goals at Work—
Progress and future challenges of Organizational Health Goals (OHGs)

To detail how the corporate culture is evolving through pursuit of our Organizational Health Goals,
we held round-table discussions between employees, Top Management, and outside Director.
01

Kats: Today, I would like to have an open discussion with all of you about the progress and04

upcoming challenges of Astellas’ Organizational Health Goals (OHGs) as part of CSP2021.
I feel I was hired for the topic of OHGs, and to drive OHGs is my mission.
On the other hand, since there are no short-term Key Performance Indicators (KPIs) for
OHGs, I would like to hear about your experiences and challenges regarding the implementation of OHGs. Additionally, I would appreciate honest feedback from Sakurai-san, ourExternal Director, from a supervisory perspective.
02

03

Two years have passed since OHGs were set in FY2021. Have you found any OHG-related05

changes in your daily work and what are they?
Ricardo: I think that OHGs helped every employee understand not only what thecompany wants from them but also what the employees can expect from it. Changing themindset is very important and we have worked hard not only to promote a mindset shift
but also to develop a working environment where people can be their best version andcontribute by working in a very cooperative way to achieve our goals.
NameIntroduction

By doing so, in the last 4 years, Astellas Brazil was able to double its sales and triple its

01 Katsuyoshi Sugita(CPO & CECO)

Katsuyoshi Sugita joined Astellas as the Head of Human Resources in FY2021. In October 2022,
he assumed the position of CPO & CECO*1 (concurrently serving as the Head of the Human
Resources), and in June 2023, he took on the role of Representative Director and Executive Vice
President*2.

operating profit. It was something that worked well by having all employees understanding

02 Eriko Sakurai

Eriko Sakurai has been the outside Director of Astellas Pharma Inc. since June 2022 and participated in Sustainability Meeting 2022. She has served in important positions in a US-based global
company, including being the representative of Japanese subsidiaries.

Takahiro: With the penetration of OHG practices, it has become easier to share ideas andRicardo Ogawa had served as the General Manager (GM) of the Brazil branch since he joined
Astellas 4 years ago. He is currently serving as the GM of the branches in Spain and Portugal,
with over 30 years of experience in the pharmaceutical industry.

venturing into new activities has been fostered, resulting in an environment where innova-

outside Director

03 Ricardo Ogawa

04 Nahrin Marino

Nahrin Marino is the Senior Vice President in the Legal Department. Prior to joining Astellas, she
had worked as an attorney at law firms and this is her 12th year with Astellas.

05 Takahiro Morikawa

Takahiro Morikawa is a research team leader in TPD (Targeted Protein Degradation) that was
selected as Primary Focus in FY2022. He has been working as a medicinal chemist for 6 years.

the value of OHGs. I think we have been very successful in implementing it in Brazil.

opinions with supervisors and team members. A culture of fearlessly embracing failure andtion is more likely to occur.
In a case of ASP3082 in my division, Targeted Protein Degradation, a researcher proposeda new approach of using protein degraders instead of continuing the inhibitor researchthat had been investigated so far to address the research challenges on KRAS G12D.

*1 Senmu Tantou-Yakuin, Chief People Officer and Chief Ethics & Compliance Officer (CPO & CECO)*2 He continues to serve as Chief People Officer and Chief Ethics & Compliance Officer (CPO & CECO)

38

Astellas Pharma Inc. Integrated Report 2023

Special Feature I

Interview with Chief
Executive Officer

Corporate Strategic Plan for
Value Creation

Value Creation Story

Strengthen Foundation
for Value Creation

Corporate Data

Roundtable: An Evolving Organizational Culture —The Organizational Health Goals at Work—

Overview of People and Organization priorities

This idea was promptly validated with the support of the leadership and team members,

P.43

leading to the early creation of a first-in-class KRAS G12D degrader. A positive atmosphere

VISION

into challenge and change can be observed in other research projects as well.
On the other hand, I feel there are two challenges in the workplace. One of them is

CSP2021: Organizational Health Goals

related to the feedback culture. I have realized that it is crucial to have a good under-

1

standing of one another in order to provide appropriate feedback. I think it is important tomake efforts to actively create white space for increasing opportunity to communicate

Brave ideas pursue
ambitious outcomes2

Talent andleadership thrives

3

We excel as
One Astellas

with one another.
Another challenge is collaboration within an organization. Since the introduction ofcalled “CSP Legal Ambassador Program,” where we put high performers in the legal teamshared objectives last year, there have been more opportunities for cross-organizational

through rotation, taking each lawyer through every aspect of the product lifecycle.

collaborations, and it has become easier to carry out research activities under specific,

They learned about research, development, commercialization, strategies, and businessrapid decision making. However, there have been instances where collaboration within theobjectives. This was what they chose to learn on top of their everyday jobs. This program isorganization, particularly between different projects has not been stimulated. I believe it is

not yet completed but it has been an absolute success. The participants made presenta-

important for the organization to foster a sense of unity, rather than working independently

tions to other members of the legal team about what they have learned. The program haswith the boundaries of individual research goals and projects. I think that cultivating ataught our lawyers not to narrowly focus on the legal projects but to understand thesense of unity can promote communication and collaboration across different researchwhole picture of the business, why projects are moving forward, and how we fit into value

projects, leading to improved overall performance and outcomes of organization.

for our patients.

Kats: I was a bit surprised to learn about your experience Takahiro but this is a verymaking educated business risk decisions, which is a key learning of the OHGs. It has

interesting comment. Like what you have mentioned, by introducing shared objectives,changed our culture and impacted the business in a positive way. It has also given the

we have promoted cross-function and cross-division collaboration. But I guess we are notbusiness more ownership of key decisions.

We’re developing lawyers that understand the business and how to support people inas conscious about the collaboration within the same division.
Of course, we also want to be more collaborative in our division. But sometimes it isRicardo: In Brazil, we have also held workshops with leadership teams to go over theexactly because we respect one another that deep and straightforward conversations with

CSP2021 and OHGs in order to make sure we all have the same and right understanding

people in the same group become quite difficult.

on the company’s strategies and goals. For example, people were a little confused about
intelligent risk-taking because they did not know exactly what indeed could be considered

Nahrin: The OHGs that resonated with me and the legal team is related to intelligent

intelligent risks.

risk-taking and learning culture. We embrace this shift in organization because we wantThus, we have come up with a list of intelligent risk-taking. Some of the risks are beyond

people to think about risk and have conversations with legal and among each other.

our control because they are dependent on others’ decisions. So we have only focused on

First and foremost, we developed educated lawyers that understand what the businessthe ones that we could manage and do something about. In the end, we were able to takeobjectives are and how they lead to value for patients. We created a 15-month program

intelligent risk effectively and get approvals from the regional team for implementation.

39

Astellas Pharma Inc. Integrated Report 2023

Special Feature I

Interview with Chief
Executive Officer

Corporate Strategic Plan for
Value Creation

Value Creation Story

Strengthen Foundation
for Value Creation

Corporate Data

Roundtable: An Evolving Organizational Culture —The Organizational Health Goals at Work—

Once Astellas’ employees started seeing actions taking place, they finally believed in

I sometimes got comments directly from my members, “We want to better understandthe process. It is great to know that Nahrin’s team has been working on risk-taking as

what the CSP2021 means for us.” I have a relatively small team compared to other countries,

well. We can definitely support our affiliates to do the right things but at the same time

but I know every one of the 185 employees in my region, and I’ve had a chance to talk totake risks appropriately.

every one of them. I’ve conducted townhall meetings, one-on-one sessions with most ofthem, and open talks with groups like what Mr. Okamura does with AMA (Ask Me Anything).

Kats: We have many great practices in Astellas, and my focus in FY2023 is to share thoseIt’s always good to come up with solutions by having frank conversations or open

great cases with all Astellas members and external stakeholders proactively. I believe this

discussions with teams, but it is important to be honest with them when running into

can help keep the momentum for transformation.

things that we cannot change. We have to tell them the truth as it is as well. Otherwise,

Sakurai-san, please share your thoughts on OHGs from the viewpoint of an External

you are going to have a group of people whining about things that cannot be changed.

Director.

Also, we have worked on creating a working environment where people feel safe to be
who they really are. I want people to freely speak up and share their feelings with others,

Eriko: I am very happy that Astellas has OHGs as a major goal in your activities and I am

provided that we always maintain our respect for each other. This is key for me. I believe insupportive of it. Organizational culture is usually the best reason that employees stay andthe end, our patients can also benefit from the changes we are working on in Astellas.

engage themselves. It is good that Astellas made this an important objective for your

Our employees can grow and get recognized, regardless of their age and gender. I am

organization globally.

very proud of having 70% of our leadership team formed by women and 50% of the senior

I also understand that this is a long journey. Culture cannot be changed overnight, andmanagement under 40 years old. We are recognized both internally and externally for ouryou have to work consistently. Perfection does not exist in this matter and there is no end

thriving young people and great female leaders. Last year, we were ranked as the 4th best

to it either. I would like to see Astellas continue to challenge and evolve.

company to work for by GPTW (Great Place to Work Institute) within the entire pharmaceutical industry in Brazil.

Effects of Global Engagement Survey (GES) and future challenges

Nahrin: What Ricardo was doing in Brazil is impactful for the organizational culture. I have
employees in Brazil who highly appreciate Ricardo’s leadership and open communication.

Kats: Global Engagement Survey (GES) is one of the measurements of the progress ofOpen communication and setting expectations are keys for the employees to under-

OHGs. Of course, GES is not a competition, but Ricardo’s team has an especially high scorestand what the organizational culture is like, which is what makes people want to stay.

compared with the rest of the Company. Ricardo, what do you think is the reason for theThis way, you can get more engagement and participation from the employees too.

high scores?

Although our global engagement scores and efforts in communication have increased
For details about Global Engagement Survey, please refer toP.46

year by year, white space remained our work to do. We discussed what is important for
the team regarding white space.

Ricardo: Open Communication is key. I encouraged the members to communicate

We have a “development day,” where the legal team takes the entire day to develop

effectively. I got to know the team well and listened to their opinions in order to come upthemselves, whatever it means for every member. Some might think about a project andwith bottom-up solutions. We have to lead by example. Once you lead by example, it ismuch easier for the subordinates to understand what is expected of them.

40

Astellas Pharma Inc. Integrated Report 2023

Special Feature I

Interview with Chief
Executive Officer

Corporate Strategic Plan for
Value Creation

Value Creation Story

Strengthen Foundation
for Value Creation

Corporate Data

Roundtable: An Evolving Organizational Culture —The Organizational Health Goals at Work—

how they could do it better strategically, while some might participate in training tofuture and respond to this survey positively. On the contrary, if people feel that GES is no

increase legal expertise. This has impacted our scores for white space in GES a great deal.

more than a survey but a competition and nothing will happen after it, it is very unlikely tosee positive changes afterward.

Eriko: When I was responsible for the global teams, I observed differences in GES scores

My next question goes to Takahiro. The research team also has a high score in GES.

among countries and regions due to cultural differences. I think it is more important to see

Please tell us your thoughts about the changes.

the changes in each country or region than to compare scores among them.
Takahiro: The members of our team are highly aware of our goal to contribute to the

Securing white space is a dilemma faced by many companies around the world. It isvery difficult for me as well, because there are always urgent matters. If you work for apatients. In the example of ASP3082, we set a highly challenging goal of achieving IND*

global company, you can work 24 hours. Therefore, I truly admire how you are making

application within 12 months from the selection of development candidate in order toimprovements to secure white space.

deliver the drug to patients faster. Despite the complexity of the manufacturing process
required for ASP3082, which is more intricate than those of conventional small molecules,

Nahrin: We have to understand that what makes good white space for me might not be

the 12-month timeline is an unprecedented speed globally. This goal was beyond what

good white space for you. For some, white space means spending time with their children,

could be achieved with conventional processes. However, we explored innovative strate-

and for others, it could be something else.

gies and took appropriate risks to successfully accomplish the goal.

We try to respect people’s time, working styles, and what they have to do.

There were many occasions when we experienced unexpected challenges. But wealways tried to make various preparations and imagine potential problems while at the

Kats: That’s another great point.

same time expecting the best-case scenarios. Of course, some preparations ended up in

I think white space is one of the challenges for us in Astellas. We have great corporate

nothing, but as a team, we agreed upon the priorities and expressed gratitude for one

cultures with traits like diligence and kindness. People also want to achieve something big.

another’s contributions all the time. I believe that we developed a sense of autonomy andHowever, we are not very skilled at prioritizing.

accountability as we engaged in tackling unprecedented and challenging goals, resulting

In my opinion, if we want to start one thing new, we need to cut out three otherin GES scores improvement.

redundant tasks. Otherwise, we cannot truly achieve something significant. This is ourI feel what Ricardo said about communication also helps accelerate changes in thechallenge in FY2023 and I believe simplifying and standardizing processes is key toteam. The foundation of intelligent risk-taking and speeding up was the result of eachmaking things smoother.

project researcher recognizing their role in the organization through dialogues with

To be creative and drive innovation, it is essential to secure enough time. I made a deep

managers, leaders and teammates, allowing everyone to consider the best possible

dive into all the details in GES scores and found the “action-taking” score is closely linked tosolutions.

the overall GES score. “Action-taking” here means whether the supervisor will take someI think having role models in a team is also incredibly significant. It was highly effective

action after the survey. If people feel, “Yes, my supervisor takes these survey results seriously,

when managers themselves embodied OHG behaviors and other leaders learned fromand he or she will take action for us.”, they usually have more positive expectations for thethem, then the behaviors spread to the researchers in the field.
* IND: Investigational New Drug

41

Astellas Pharma Inc. Integrated Report 2023

Special Feature I

Interview with Chief
Executive Officer

Corporate Strategic Plan for
Value Creation

Value Creation Story

Strengthen Foundation
for Value Creation

Corporate Data

Roundtable: An Evolving Organizational Culture —The Organizational Health Goals at Work—

Eriko: Allow me to change the perspectives to talk about our Board of Directors (BoD)

Expectations for Astellas and what we should focus on

meetings. Many of you probably don’t know what does BoDs talk about, but we have a lotof discussions related to people and organizations, such as reviewing GES results andKats: Not only did you consider ambitious goals but you also explored approaches tosuccession planning and listening to reports on Leadership Programs.

mitigate risks. This is a great demonstration of “hope for the best and prepare for the worst.”

Of course, from the perspective of governance, we do not make decisions regarding

I also agree that role models are crucial. The selection and quality of the leaders are vital inspecific individuals or activities, but we oversee whether the systems and processes related

any kind of transformation.

to OHGs are truly functioning for Astellas because people are the most important part ofLastly, how do you expect Astellas to change in the future through the promotion of

the organization. It is people in Astellas who communicate, make decisions, and drive

OHGs? Please also tell us about what you personally want to focus on in the future.

innovations. As BoD, we prioritize how you engage and grow.
On behalf of the entire BoD, especially the External Directors, I want you to know that

Ricardo: I expect Astellas to keep fostering new ways of working. This is going to be

we truly support OHGs. I am genuinely happy to learn about the efforts you’re making

especially important when we consider our market entry models for the new pipelines.

globally and how serious you are when committing yourself to the goals.

We cannot afford to fail in delivering products to our patients so we need to come up
with a different mindset and collaborate, with OHGs serving as a significant guide.

Kats: We have already introduced many new initiatives and FY2023 will be the year for full

By focusing on talent development based on OHGs, we will transform to become a more

implementation and deep communication. Communication about “why” will be the key.

innovative pharmaceutical company.

Furthermore, we will continue to simplify processes at work to avoid wasting resources.
I believe decision-making and innovation can further accelerate with our efforts. Thank you

Nahrin: I think we still have some work to do with making decisions with intelligent risk-

so much for your participation today.

taking. We have built psychological safety, where the culture truly encourages bringing up
your innovative ideas. Now, we need to continue on our journey to take risks and makebusiness decisions wisely.
Takahiro: I hope the promotion of OHGs will further integrate into the One Astellas
mindset. A company that is filled with employees who perceive the activities of others as
their own, possess a consciousness to maximize achievement for the organization andthe company, and autonomously take action will deliver more innovative pharmaceuticals
to patients.
Personally, I want to involve the necessary talents to verify numerous ideas andapproach research challenges with the consciousness of achieving them not just as ateam, but as Astellas and carry out the One Astellas mindset.

42Interview with Chief
Executive Officer

Astellas Pharma Inc. Integrated Report 2023

Corporate Strategic Plan for
Value Creation

Value Creation Story

Strengthen Foundation
for Value Creation

Corporate Data

People Strategy People and Organization for Innovation
To achieve our vision, the active engagement of our colleagues is absolutely crucial. Investing in ourpeople is not only vital for Astellas’ future but also for enhancing our current execution capabilities.

Organizational Health Goals

We will continue to invest in our people, viewing it from both short-term and long-term perspectives.

The Organizational Health Goals (OHGs) are a set of goals established in CSP2021 to improve Astellas’ ability to execute

In our Corporate Strategic Plan for 2021 (CSP2021), we introduced new Organizational Healthby building a company culture that seeks to realize ambitious goals through driving innovation, advancing our talent andGoals (OHGs) designed to elevate the company’s execution abilities. Astellas’ HR division is fully

leadership development, and fostering collaboration. The Organizational Health Goals (OHGs) are a set of goals establishedcommitted to deliver the ‘Priorities of Astellas HR,’ which we believe will directly contribute toin CSP2021 to improve Astellas’ ability to execute by building a company culture that seeks to realize ambitious goals

realizing CSP2021 and, ultimately, our overarching vision. We are placing a particular emphasis on

through driving innovation, advancing our talent and leadership development, and fostering collaboration.

high impact initiatives geared toward achieving our OHGs.
Interviewing employees and leaders around the world and collect their opinions

Overview of People and Organization priorities

VISION

Planning
process

CSP2021: Organizational Health Goals

1

Brave ideas pursue
ambitious outcomes2

3

Talent andleadership thrives

We excel as
One Astellas

CSP2021(A) Organizational culture /mindset transformation

Priorities of Astellas HR

P.44(B) Developing global HR
policies that support ourpeople and organization(C) Transforming theorganization into an
innovation engine• Extensive fear of failure andunwillingness to take businessrisks to achieve innovation• Conservative objective setting• Reluctance to update anddevelop new systems andprocesses to meet new
challenges• Unclear image of leadership to
generate innovative ideas• Lack of development plans tofoster leadership• Evaluation system that promotes
departmental optimization• Silo situation and lack of trust
between divisions

1. Brave ideas pursue
ambitious outcomes

2. Talent andleadership thrives

3. We excel as
One Astellas

Aggressively take on challenges
for innovation and ambitious
outcomes

Environment in which excellent
people have ownership anddemonstrate leadership

Collaborate across divisions toachieve shared goals for all
Astellas• Launch of psychological safety
playbook• Implementation of ambitious
objective setting for all individual
employees, as well as fordivisional objectives for FY2022• Introduction of Dansharism• Launch of white space toolkit for
managers• Establishment and launch of theAstellas Leadership Expectations• Completion of leadershiptraining to all Astellas leaders• Introduction of global feedback
initiative• Execution of multiple talentdevelopment initiatives• Implementation of sharedobjectives process• Removal of focus on divisional
performance and replacementwith 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

P.29

Organizational
Health Goals(D) Monitoring progress through reliable and data-driven approach

Priorities of Astellas HR
Astellas HR is a single division overseeing both domestic and overseas operations. At Astellas, we recruit and promote
our people globally. We furthermore favor a data-driven approach using all kinds of information including businessInitiatives &Progressand organizational data to monitor the progress accurately. We can use the data to generate inside of the individualorganization timely.
We identified three core HR priorities: (A) organizational culture / mindset transformation, (B) developing global HR
policies that support our people and organization, and (C) transforming the organization into an innovation engine.
We believe that these priorities are supported by (D) monitoring the progress through reliable and data-driven approach.

For details, please see next page

43

Interview with Chief
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Astellas Pharma Inc. Integrated Report 2023

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Value Creation

Value Creation Story

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Corporate Data

People Strategy People and Organization for Innovation
Priorities of Astellas HR(2) Integration into global HR policies
In line with the globalization of our business, we are transitioning to a global organization divided by function while(A) Organizational culture / mindset transformation

also promoting the integration and harmonization of HR systems. We revised our objective setting and evaluation

Astellas encourages employees to grow through intelligent risk-taking and continuous learning, and is focusedprocesses. We are aiming to enhance our performance as One Astellas by setting cross-functional objectives at theon ensuring psychological safety and building a feedback culture. With this in mind, in 2022 we introduced adivisional level and promoting ambitious objective-setting and launching of our feedback tool at the individual level.

feedback tool globally that allows for feedback between all layers of the Company, not limited to supervisors

With regard to our rewards and recognition systems, we changed the calculation factor for bonus payments to be

and their subordinates. So far (as of the end of January 2023), there have been 4,324 submissions of feedback

based on company-wide performance rather than divisional performance. We also harmonized our job grading

around the world.

system to ensure consistency in grading regardless of where employees work or which division they belong to.

In addition, Ask Me Anything and Live Stream interactive sessions have been developed to promote

We believe these HR measures have strengthened our competitiveness in recruiting talent globally.

two-way communication between Top Management and employees. Ask Me Anything sessions are large-scale

Objective setting / Evaluation systemfireside chat sessions open to employees from around the world while Live Stream sessions are places for Top
Management to openly share their experiences on a specific theme. These shared experiences are not only
about moving tales and success stories, but also included sharing failures, regrets and the lessons learned.
The Live Stream sessions have been well received by employees, with the first attracting approximately 7,000
employees globally, and the second around 6,500.

Division• Cross-functional ambitious sharedobjectives

Individual• Ambitious objective setting• Launch feedback tool

Rewards / Recognition

Integrated job grading system• Change of the calculation factor of
bonus payment amount from “divisional
performance” to “company-wide
performance”• Launch recognition program• Operation of a globally integrated
grading system• Simplification of grade classification(3) Recruitment of PhD talent(B) Developing global HR policies that support our people and organization

Numbers globally:(1) Building up a diverse workforce through the deployment of succession plans globally in*1 Based on data self-reported by employees.
*2 Includes directors.

1,281 (as of end-March 2023)

Globally, Astellas applies a job-based approach to recruiting PhD talent.

a consistent approach
At Astellas, we focus on the creation of succession plans for important positions. As of the end of September

To this end, we have been proactive in approaching doctoral degree students in areas that rarely lead to2022, non-Japanese employees account for 57% of the 178 positions above executive director. Out of the 522

employment in industry, also recruiting individuals based on referrals from PhD talent within the Company andemployees selected as successful candidates, 43% were non-Japanese and 36% were female, making for a

recruiting year-round to increase opportunities for interacting with job seekers. By head-hunting employees

diverse talent pool in our succession planning. At the level above senior director, non-Japanese employees

from other pharmaceutical companies overseas and hiring PhD talent from the academic sector both domesti-

account for 68% of the 238 positions, while for 38% of the 551 successor candidates, we are securing non-Jap-

cally and internationally, we are greatly enhancing our competitiveness within the industry.

anese employees and 42% of female employees.

(4) Promoting talent mobility through internal Job Posting system

In this way, even for above senior director positions, Astellas is already selecting talents regardless of nation-

In pursuit of greater mobility among the individuals weality and gender. Based on the philosophy of ensuring the right person in the right position, we will continue

recruit and develop, Astellas utilizes all available recruit-

to select the best people from around the world as successors.
Positions above Executive Director: 178
Nationality

Non-Japanese: 57%
Japanese:
39%

Vacant: 4%

Number of successors: 522
Nationality

Positions above Senior Director: 238
Nationality

Non-Japanese: 68%
Japanese:
26%

Vacant: 6%

ment channels, including those outside the Company, to
Non-Japanese: 43%
Japanese:
57%

Genderensure that we hire the right people. In recent years, theFemale: 36%
Male: 64%

Non-Japanese: 38%
Japanese:
62%

GenderInternal hires
Mid-career hires(Persons)

104

percentage of employees with professional skills has been
rising—in short, the weighting of mid-career recruits isincreasing. By FY2022, the number of mid-career hires had

Number of successors: 551
Nationality

Number of hires

grown to 105, and the number of internal hires to 104,

Female: 42%
Male: 58%

contributing to greater job mobility.

44

25
28
FY2017

20

76

76

66

86

105

FY2018FY2019FY2020

FY2021

FY2022

Interview with Chief
Executive Officer

Astellas Pharma Inc. Integrated Report 2023

Corporate Strategic Plan for
Value Creation

Value Creation Story

Strengthen Foundation
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Corporate Data

People Strategy People and Organization for Innovation(C) Transforming the organization into an innovation engine(D) Monitoring progress through reliable and data-driven approach

Organizational flattening(1) Visualizing and sharing data using HR Leadership Dashboard

Astellas is promoting the organizational flattening to build an environment that encourages innovation.

Astellas aims to promote organizational optimization and foster a sense of ownership through the visualization

To promote fast decision-making, we believe it essential to reduce the number of layers in the organization.

and sharing of data. As one such initiative, we released the HR Leadership Dashboard. This tool enables us to

In principle, we aim to reduce the number of layers from the CEO to be six or less. Furthermore, the SPOC*1

visualize various organizational data including personnel composition, the status of hiring and termination,

should be six or more in principle.

SPOC, team sizes, and so forth. By looking at the organization from multiple angles, it is possible to identify

The percentage of departments separated from the

1

62022 to 77.1% by July 2023, such that the average SPOC

business premised on the entire picture.

6

for all departments rose from 5.2 people in April 2022
to 6.02 people by July 2023. By March 2024, we expect

issues that may be overlooked when focusing on individual data points, facilitating a strategic approach to

To Be: Organization with SPOC≧6

CEO by six or fewer layers increased from 53% in April

6

these figures to rise still further to 92% and 6.4 people,
respectively.
*1 SPOC (span of control): the number people reporting to a single manager.

TOPICS
Concept of HR organizational reforms
In order to achieve the goals set in CSP2021, we are encouraging employees to take up new work
styles as a means of further accelerating innovation. By having a single worldwide HR division, we seek
to find a smarter and simpler approach to ensuring that the right person in the right position, nurturing
talent more effectively and enhancing the Company’s ability to execute.
In that context, from April 2023 through April 2024
Astellas’ HR division is progressively introducing “HR

Operations

People Partners” in each region. These HR People
Partners assist employees and managers in resolving HR
issues and provide other services including execution of
HR processes and organizational change. In this manner,

Centers of
Excellence(2) Correlation between remote working andCustomers
Business
Partners

and organizational strategy in each division.

Engagement
score

Once every quarter or less75

Once a month70

Once a week70

remote employment worldwide.

Two or three times a week71

*2 Scores assigned according to workplace attendance, with those attending once
every quarter or less earning the highest scores.

Four or five times a week70

We surveyed the entire workforce to investigate the relation-

PeoplePartners

ship between remote working and engagement scores* .
2Employees predominantly working remotely recorded highHR Business Partners provide each division with support
focused on the development and execution of people

Frequency of workplaceattendance

employee engagementscores, based on which we plan to continue offering fully
HR Transformation Lead /Excellence & Capability Enhancement

45Interview with Chief
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Astellas Pharma Inc. Integrated Report 2023

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Value Creation

Value Creation Story

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Corporate Data

People Strategy People and Organization for Innovation(3) Global Engagement Survey

Improvement initiatives already completed and those yet to come71
25,86582%

Engagement score
Number of comments
Response rate

75% of answers to questions
showed improvement*1

At Astellas, we are using the results of this survey to devise concrete measures for addressing areas deemedin need of improvement. On the subject of white space, for example, “inefficient processes and tools,” “lack ofexperience,” “lack of resources,” and “lack of time” were among the root causes identified in comments. Based

Over 61% of employees provided more than one comment*1 Compared to the previous survey (Jan 2022)

on these results, we see opportunities for improving white space in instances where there is no flexibility interms of budget or headcounts, by specifying an order of priority and allocating resources (e.g., staff, funding,Analysis of results from FY2022 surveytime) accordingly.

Once a year, Astellas conducts a global survey with a view to measuring employee engagement and identi-

As one specific initiative in this regard, we held a Leaders’ Summit in FY2022 where we assigned an order

fying organizational issues as well as opportunities for improvement. Through this survey, we can visualizeof priority to tasks and identified work that appeared to be wasting precious resources. Furthermore, inscores for each item, individually assess progress toward each OHG, and perform trend analysis of comments

FY2023 we have fully embraced digital transformation in project management, with a view to securing morewith AI, enabling us to identify both organizational strengths and opportunities to improve.

time for employees by supporting decision-making and execution.

In the survey carried out in October 2022, 82% of all employees responded and 75% of answers toquestions showed improvement over the previous fiscal year. While continuing to focus on the top three
items which we regard as our strengths, we see the bottom three items as providing opportunities for
improvement and to that end we are taking steps to create a better workplace environment and increase

White space

engagement levels. By monitoring the results of these initiatives through the next survey, we will continue tofollow the Plan-Do-Check-Act (PDCA) cycle.
Examples of Global Engagement Survey items and responses*
Item

2

Action taking

Question

Change from Jan 2022

Non-discrimination

I work in an environment that is free from harassment and discrimination.

+1

Contribution to success

I understand how my work contributes to Astellas’ success.

+1

Integrity

People at Astellas behave with integrity at work.

+1

White space

We have the resources (e.g., time, tools, expertise) needed to explore new ideas.

0

Action taking

I believe meaningful action will be taken as a result of this survey.

–2

Pay for performance

The better my performance, the more I will be rewarded.

+1*3

Our strengths
Nondiscrimination
A culture thatrecognizes, complements, and makes
the most of eachother's differences

PurposeAct with a consistent sense of
purposePay for
Performance

Our opportunities
Integrity
Always honest
choices anddecisionsWhite space

Action taking

Resource needed to
explore new ideas

Implement
measures to address
issues identified
from the survey
results

Initiatives already implemented in FY2022

Initiatives planned in FY2023• Held Leaders’ Summit where we assigned an order ofpriority to tasks and identified opportunities either to halt
activities or pursue efficiency gains• Conducted two “Global Dansharism” campaigns promoting
elimination of low-priority work

• Have Transformation Office identify, manage, and carry out
key reform projects geared toward ensuring white space• Look at Dansharism training to create more white space
And so forth• Shared results of engagement survey with all employees• Held management-level workshops in each area to enhanceaction-planning skills, recognizing importance of “Action
taking”• Convey that importance to employees, stressing relationshipbetween engagement survey feedback and company
actions, encouraging employees to take actions• Have all team managers go over survey results with teammembers, with the goal of settling on one action item
And so forth• Held quarterly forums for leaders, managers, and employees,
to provide training on feedback methods• Approved FY2023 revisions to compensation processes• Cross-regional harmonization of reward and recognition
systems• Global introduction of recognition system
And so forth

Separate analysis of engagement scores

Pay forperformance

We use results from the Global Engagement Survey to analyze progress toward each
Organizational Health Goal, but also perform various separate analyses. For example, in analyzing

Compensation
based on results

lower levels. Also, from our analysis of white space we learned that directors feel the mostpressure in this regard. By performing these separate analyses, we can narrow our focus when

By employment
type

addressing opportunities for improvement.

46

By tenure
By employment
level
By individual
performance

responses by layer, we found that managers scored higher on engagement than employees at*2 Partial excerpt of survey questions.
*3 Scores have improved relative to FY2022, but we see scope for further improvement.

By nationality

Astellas Pharma Inc. Integrated Report 2023

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Corporate Strategic Plan for
Value Creation

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Corporate Data

People Strategy Engagement, Diversity, Equity and Inclusion
To become a life science innovator, diversity, equity and inclusion must be leveraged
to unlock employee engagement, drive innovation, and improve patient outcomes.
Our EDEI vision will be realized when our people, leaders and suppliers reflect therich diversity of our patients; our people feel a high sense of inclusion, experience
employment equity and collectively drive innovation; and our patients experiencefavorable and equitable health outcomes.

Composition
ratio ofemployees
by region

Foreignnationality ratioof Division
Heads

Mid-career
hiring rate
(Japan)Percentage offemalemanagers

JAPAN 34%
United States 25%
Established Markets 23%
International Markets 10%
Greater China 8%

Foreign nationality 53%
Japanese nationality 47%

Mid-career hiring 55%
New graduates hiring 45%

Inside: Japan 18%
Outside: Global 43%
Female managers

Our Strategy
Data Insights• Leverage data to deeply understand the employee, patient and supplier experience through an EDEI lens
• Monitor progress, conduct self-assessment and benchmark against best-in-class organizations to improve upon opportunities and celebrate successes

EDEI Plans• Create custom EDEI plans and partner with divisions on execution• Consult with divisions to develop tailored EDEI plans and partner on implementation

People Experience• Seek to better represent and bring the perspectives of the patients and communities we serve among Astellas leaders and employees as a whole• Brand Astellas as an Employer of Choice for diverse talent• Ensure equity across the employee lifecycle

Culture• Build global cultural competence and empathy across all levels of the organization• Value diversity in all its forms to instill psychological safety, belonging, and empowerment that unlocks the full potential of people to innovate and succeed

Structure• Launch Global EDEI Governance Council and Divisional EDEI Councils to foster decision-making, collaboration and accountability• Globalize and expand Employee Impact Groups (EIGs) to fully represent and include all underrepresented groups

Our Mission and Goals

Progress in FY2022

ENGAGEMENT

All people are highly engaged;
Goal: Parity in high employee engagement across all identities• Overall engagement score - 71; High response rate - 82%; High volume of qualitative data ~ 22K comments• Expanded voluntary self-disclosure demographics to include gender identity and sexual orientation

DIVERSITY

Our people, leaders and suppliers reflect our diverse patients;
Goal: Our employees, leaders, and suppliers reflect our patients and communities• Had C-suite level visible championship of diversity during Hispanic and LGBTQ+ Employee Impact
Groups sessions• Netted positive year-over-year growth in global female representation at the Senior/Executive Director + levels

EQUITYAll people experience equity in health and work;
Goal: Everyone experiences equity across the employee and patient lifecycles,
have equitable access to our portfolio, and achieve equitable health outcomes• Ensured equal pay for equal work based on gender and US race/ethnicity• Increased female representation in VP succession planning; The % of overall female Senior/Executive Directors
matches the % of female Senior/Executive Directors on succession plans

INCLUSION

All people experience inclusion;
Goal: Parity in high reporting of psychological safety, belonging, and empowerment• Created EIG Globalization Strategy to streamline process to join and/or propose a new EIG• EIGs and Functions held various forums and programs to instill a sense of community and education
about diversity

47

Interview with Chief
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Astellas Pharma Inc. Integrated Report 2023

Corporate Strategic Plan for
Value Creation

Value Creation Story

Strengthen Foundation
for Value Creation

Corporate Data

Commercial Strategy Interview with Chief Commercial Officer

Q

Creating leading medicines that benefit
patients requires ambition to bebest-in-class and agility to adapt to
new technologies and ways of working

Shaping a culture that aims to be best-in-class and adapting to
new technologies and therapeutic areas are the main challenges forthe customer-facing organizations in Astellas.
The most important element of my vision is to shape the culture of the Commercial organization worldwide to aim to be best-in-class in everything we do. This links to the ambitious
Organizational Health Goals set out in CSP2021, which calls upon us to reward people
appropriately for reaching stretch goals. It starts with the will to win, with the inner ambition in the organization not to accept being second - after all, creating leading medicines
means being the number one in the market.
From a strategic point of view, we kicked off a Growth Strategy to review where thebiggest opportunities are and where we can best use our resources. We are asking: Whichbrand in which market offers more growth opportunity, and are we resourcing it correctly?
Attached to that is the question of the collaboration between both the Medical Affairs andCommercial organizations and the global and local organizations: are we all aligned toachieve the maximum impact on our customers?
The Commercial organization I inherited has successfully built globalized functions
for omnichannel marketing, training, certain kinds of event management, and, of course,
brand management. Where I think we can improve is in terms of how these global elements
deliver to the different geographies and how this process becomes best-in-class. For instance,
we can shorten the timelines for the review of materials or increase the percentage of global
materials suited for local usage. We also have to look at new technologies. This is something
the industry as a whole is struggling with in a post-COVID world. To become the leading
company in this space, we will have to understand, absorb, and master the deployment oftechnologies like AI algorithms that make predictions about future resource deployment.
I think of the customer-facing Commercial and Medical Affairs organizations not assomething static, where the only thing that changes are the products that we launch.
Rather, I see them as living organisms that on the one hand have to learn and adapt to newtherapeutic areas when we launch new products, and on the other hand have to learn andadapt to new ways of engaging the customer and to building the technology that helps us
with that.

Chief Commercial Officer (CCO)

Claus Zieler

Q

What is your vision for the Commercial organization andhow are you thinking about organizational reform?

Tell us about your goals as the new CCO andthe challenges involved in achieving them.

Creating leading medicines in both new and existing therapeutic areas
and effectively communicating the benefits of our treatments are
the major goals for the customer-facing organizations in Astellas.
We have fantastic innovative assets to launch over the next few years. That is very exciting,but creating leading medicines also takes the concerted effort of the whole organization,
to shape the scientific understanding of our customers on how new products change
existing treatment paradigms and how they help patients lead a longer or a better life. Eachof our launches is an opportunity to create leading medicines in the various therapeutic areas.
Beyond the launches, we also have in-market assets that deserve our full attention.
Our flagship product XTANDI is still growing wonderfully after ten years on the market.
We just had a dataset (EMBARK study) published and we will communicate this new dataset
to payers, prescribers, and key external experts after regulatory approval of the anticipated
M0 CSPC indication for XTANDI to ensure that the drug is used in the best possible way totreat prostate cancer. With XTANDI and our other in-market products, we will continue tofocus on expanding the number of patients that can benefit from these treatments.
One challenge is that we will continue to enter new therapeutic areas, such as gastriccancer and ophthalmology, and gene therapy further down the line. Our Primary Focus
model sources innovation where the technology takes us. So, for the customer-facing Commercial and Medical Affairs organizations, the challenge is that each new technology may
require us to learn about a new target group of customers, about how the market in the newtherapeutic area works, and about competitive treatments.

48

Astellas Pharma Inc. Integrated Report 2023

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Special Feature II

VEOZAH: New nonhormonal treatment option for VMS due to menopause
Back ground info
Vasomotor symptoms ( VMS), characterized by hot flashes and/or night sweats, are the mostcommon symptoms of menopause for which women seek treatment.* 1, * 2, * 3 They occur in
up to 80% of women aged 40 to 65* 4, * 5, * 6 and persist for a median of 7.4 years.* 7 Today in
the US, there are over 30 million postmenopausal women exist*8 , with 11 million experiencing
moderate to severe VMS. However, many cannot or choose not to take hormone therapy. As aresult, there has been a steady decline in its use. In the US alone, the total of hormone therapy
patients from 2000 to 2022 has declined by 86%, which is approximately 25 million patients toless than 4 million. Our robust market research also showed us that more than 60% of womenexperiencing VMS (in the US) will not take hormone therapy for personal or medical reasons.
Despite that, many are seeking treatment. During the COVID pandemic, all three
SKYLIGHT studies (Phase 3) recruited faster than ever – faster than any of Astellas’ otherstudies – and maintained high rates of patient retention across all studies. This was aremarkable accomplishment and suggested that women want treatment and there is anexisting unmet need for safe and effective nonhormonal treatment options—and the
profound reaction we saw externally to the US FDA approval of VEOZAH reinforced theenthusiasm and readiness for our first-in-class therapy.

> 60 %

Patients will not take hormone therapy for
personal or medical reasons~ 50 %

Patients with moderate to severe VMS due
to menopause are willing to use and/or
ask physician~ 40 %

Physicians likely to prescribe

US Estimated HT Patients (000s)
30,00025,000*1 Utian WH. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Health
Qual Life Outcomes. 2005;3:47.
*2 Jones RE, Lopez KH, eds. Human Reproductive Biology. 4th ed. Waltham, MA: Elsevier, 2014:120.
*3 Williams RE, Kalilani L, DiBenedetti DB, Zhou X, Fehnel SE, Clark RV. Healthcare seeking and treatment for menopausal symptoms in the United States. Maturitas. 2007;58:348-58.
*4 Freeman EW, Sammel MD, Sanders RJ. Risk of long-term hot flashes after natural menopause: evidence from the Penn Ovarian
Aging Study cohort. Menopause. 2014;21:924-032.
*5 Williams RE, Kalilani L, DiBenedetti DB, Zhou X, Granger AL, Fehnel SE, et al. Frequency and severity of vasomotor symptoms
among peri- and postmenopausal women in the United States. Climacteric. 2008;11:32-43.
*6 Whiteley J, Wagner JS, Bushmakin A, Kopenhafer L, Dibonaventura M, Racketa J. Impact of the severity of vasomotor symptoms
on health status, resource use, and productivity. Menopause. 2013;20:518-524.
*7 Avis NE, Crawford SL, Greendale G, et al. Duration of menopausal vasomotor symptoms over the menopause transition. JAMA
Intern Med. 2015;175(4):531-9.
*8 Kantar Health. Menopause Literature Review. 2017.

86 %20,000Total HT Patients
2002-2022

15,00098 %Premarin Family Patients
2002-2022

10,000
5,000

0

1992

1994

1996

1998

2000

2002

2004

2006

2008

2010

2012

2014

2016

2018

2020

2022

*9 Source: IQVIA NPA
Market Definition: HRT – ATC3 G03C Estrogen (Oral), G03F Estrogen Progestogens Combination (Oral) ; Premarin Family – Premarin, Prempro
Patient estimate = Total Days of Therapy/182 days

49

Interview with Chief
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Special Feature II

Corporate Strategic Plan for
Value Creation

Value Creation Story

Strengthen Foundation
for Value Creation

Corporate Data

VEOZAH: New nonhormonal treatment option for VMS due to menopause

Approval

Outlook

VEOZAH is the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat
moderate to severe VMS due to menopause in the US *7 VEOZAH uses a novel mechanism ofaction (MOA) to target the root cause of VMS, helping restore balance in the brain’s
temperature control center and reduce the frequency and intensity of hot flashes.
Since approval, the media coverage has been extraordinary and includes every major
top-tier media outlet in the US, including on America’s most watched national morningshow and every national broadcast network, which drove significant reporting in local
markets and conversations online. Numerous media have said VEOZAH could be a“game-changer” for women, highlighted the unique MOA, and heralded this approval as “great
news for women.” More importantly, external experts have expressed their excitement for“this new class of drug” noting “we need better nonhormonal therapies for those women
who cannot or who choose not to take hormone therapy.” To quote a Contemporary OB/
GYN article, “A new drug is here to make waves in the menopause symptom treatment
landscape.”

Through our extensive market research, we have identified roughly 2 million women and
97,000 healthcare professionals (HCPs) as potential early adopters. These women are
extremely bothered by VMS and tend to talk openly about menopause and their experienceswith family, friends and HCPs. In fact, many want to reframe how menopause is viewed andremove the stigmas. They are also actively involved in their healthcare and motivated tohave informed discussions with providers. While we don't expect to reach 2 million in thefirst year or at peak, it indicates the size of our target audience. With regard to HCPs, VEOZAH
will be primarily prescribed by obstetrician-gynecologists (Ob-Gyns), Primary Care Physicians
and General Practitioners. These early adopting HCPs are knowledgeable about data, treatments and women’s health in order to help their patients find solutions; they are also
willing to try new women’s health products.
To maximize the value of VEOZAH and drive market share, we are combining our provencommercial expertise with fresh, innovative strategies and tactics to build and grow an iconic
brand. We’ve successfully launched products with novel MOAs, established market leadershipwith therapies predominately prescribed by Ob-Gyns, and created strong relationships in thewomen’s health space. Within the US, we have had focused direct-to-consumer (DTC) efforts
since the launch of VESIcare in 2004 and Myrbetriq (mirabegron) in 2012. And there are many
similarities between these models and VEOZAH – specifically, the need for provider and patient
education is strong and stigmas associated with the conditions are high. As the landscapeevolves, our commercialization strategies stay at the forefront of pharmaceutical marketing,
exploring new channels. We have an extremely experienced, knowledgeable and agile sales
force with proven market leadership and capabilities in place to support this launch.

Successfully launching products with novel MOAs

1,300+

News Stories

90+

Ex-US News Stories

Creating strong relationships in the women’s health space

1,600+

Experienced, knowledgeable and agile sales force

Social Media Posts

50

Astellas Pharma Inc. Integrated Report 2023

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Executive Officer

Corporate Strategic Plan for
Value Creation

Value Creation Story

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for Value Creation

Corporate Data

VEOZAH: New nonhormonal treatment option for VMS due to menopause

To help drive brand awareness, we have invested heavily in a robust, integrated andanalytics-driven multichannel launch campaign. Our aim is to deliver the right messages, tothe right individuals, through the right channels, at the right time, with the goal of creating
a consistent, engaging and trusted brand experience. We created dynamic content and are
utilizing print materials, videos, broad-based media, digital tools and various advertising
platforms, including TV, as well as congresses, speaking engagements and credible external
voices. Our brand awareness activities will be closely evaluated to maximize our investments and achieve our goals. This ongoing assessment will allow us the flexibility toadjust and scale our campaigns, as needed to help ensure we are meeting our forecasts.
We want to redefine how VMS is targeted and ensure individuals understand the innovative
aspects of VEOZAH: It is a first-in-classtherapy with a novel MOA to target theroot cause of VMS. It is not a hormone
and does not behave like estrogen.
We are confident in our ability tomake VEOZAH an important therapeutic
option for women with moderate to severe
VMS. This confidence translates into what
we think will be a significant growth driverfor Astellas over several years, thus helping
us achieve our CSP2021.

Voice
I’ve learned throughout my years in clinical practice that every patient’s experienceduring the menopause transition is unique. Some patients report mild symptoms, while
what others experience is severe. Yet one thing my patients have in common are beliefs
such as “I should accept it as normal” and “there is nothing I can do,” especially whenexperiencing hot flashes and night sweats, also known as VMS.
VMS due to menopause are the most commonly reported symptoms, and can disrupt
quality of life and daily activities, including sleep and workplace performance, but treatment
options have been limited.
Hormone therapy is effective; however, I have patients who are reluctant about taking
it, and others simply cannot due to contraindications. And unfortunately, because othernonhormonal therapies are often less effective and not well tolerated, my patients often feel
helpless – and I feel limited in the options I offer.
Healthcare is about more than making the accurate diagnosis and prescribing medication. It’s important to take a holistic approach to patient care, and education is critical.
Some of my patients are embarrassed or hesitant to talk about their symptoms due to stigma
and shame associated with menopause. This is why encouraging open and honest discussions
is crucial to improving menopause care.
I’m delighted Astellas is working to elevate the conversation around women’s healthin midlife, and to provide resources and solutions that demonstrate our commitment towomen’s changing healthcare needs during this natural life stage. I’m encouraged by theincrease in research and surge in technology offerings, as well as how menopause discussions
are becoming mainstream. I’m optimistic these efforts will inspire more women to speakwith their providers about symptoms and treatments.
With VEOZAH, we have a tremendous opportunity to help many of those sufferingfrom moderate to severe VMS in the US, and hopefully in other countries soon. I’m extremely
proud to be part of the organization and team that pioneered afirst-in-class treatment for a condiShayna Mancuso,
tion that’s lacked innovative
D.O. (Doctor of Osteopathic Medicine),
therapies for too long. As a physiFACOG (Fellow of the American Congress
cian, I’m excited to offer myof Obstetricians and Gynecologists),
eligible patients a new approach
Medical Director Specialty,
that may provide meaningful relief.
U.S. Medical Affairs

51Interview with Chief
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Corporate Data

Commercial Strategy Main Product Sales
Potential peak sales of XTANDI and Strategic products

Key events expected in FY2023

For XTANDI, potential peak sales have been revised upward to more than 700 billion yen,incorporating the recent sales trends, M0 CSPC submission plan in Europe and FX rate trend.
For VEOZAH, PADCEV, XOSPATA, and zolbetuximab, the range of potential peak sales
remains unchanged from the Corporate Strategic Plan 2021 (CSP2021) announced in May
2021. In particular, VEOZAH and PADCEV are expected to be strong growth drivers during
the CSP2021 period.
On the other hand, the potential peak sales for EVRENZO have been revised downward tounder 50 billion yen based on recent sales trends.

For XTANDI, regulatory application for the additional indication of non-metastatic castration-sensitive prostate cancer (M0 CSPC) was approved in the US in August and is expected
to be filed in Europe in the latter half of FY2023. For PADCEV, topline results from the EV-302
study are expected between September and November. If the results are obtained on scheduleand the data are positive, regulatory submission globally is expected in Q4. For zolbetuximab,
regulatory applications for gastric and gastroesophageal junction cancer were submitted inJapan and the US in May, and in Europe and China in June. For VEOZAH, regulatory approval
was obtained in the US in May, and the regulatory decision is expected for Europe between
November and January next year.
Key Events in FY2023* 3

Potential Peak Sales* 1

Product(Global, billion yen)

Q1 (Apr-Jun)

Q2 (Jul-Sep)

Q3 (Oct-Dec)

Accepted (M0 CSPC; US)XTANDI (enzalutamide)

700 or more

VEOZAH (fezolinetant)

300 - 500

PADCEV (enfortumab vedotin)*

Filing (M0 CSPC; Europe)

Filing (M1 CSPC; China)
Regulatory decision (US)Regulatory decision (Europe)
EV-302 TLR

300 - 400

2

XOSPATA (gilteritinib)

100 - 200

zolbetuximab

100 - 200

Q4 (Jan-Mar)

Filing (1L mUC; global)

Accepted (Japan, US, Europe, China)

Regulatory decision
Regulatory submission
Data readout*1 Only indications undergoing pivotal studies are included
for projection. (as of April 2023)*2 Sales for Americas are calculated based on the sales
booked by Seagen.
*3 As of August 31, 2023.

Forecast of main products(billion yen)

FY2022Act

FY2023FCST

YoY

XTANDI

661.1

669.9

+8.8
(+1%)

PADCEV

44.4

66.7

+22.3
(+50%)XOSPATA

46.6

49.3

+2.7
(+6%)

VEOZAH-

49.3-

XTANDIPADCEVIn the US, the approval for the additional indication of non-metastatic castration-sensitive prostate cancer (M0 CSPC) is expected within FY2023. Although the sales contribution in this fiscal
year will be limited, promotional activities will be more active after the approval, which is expected to have a positive synergy effect on the existing indications.
In China, reimbursement for the additional indication of non-metastatic castration-resistant prostate cancer (M0 CRPC) started in March 2023, which is expected to contribute to sales.
On the other hand, sales growth in Europe is expected to be moderate due to the increasingly competitive environment and the negative impact from pricing pressure.

In the US, the additional indication for first-line treatment was approved in April and is expected
to be a growth driver going forward. In addition, PADCEV is recommended as first-line treatment
for metastatic urothelial cancer in the NCCN guidelines, which many physicians refer to when
making prescription decisions.
In Europe, further growth is expected by obtaining reimbursement in major markets
such as Germany, France, Italy, and Spain. In Japan, continued growth is expected through further market penetration with the current indication.

XOSPATA

Regulatory approval was obtained in the US in May 2023. There is confidence in the market research carefully conducted to date, and from the market research results, that a high unmet
medical need for treatment of VMS and a strong demand for effective non-hormonal therapies
were recognized. Based on this confidence, rapid market penetration is expected. To achieve
rapid penetration and to ensure the opportunity for sales expansion, VEOZAH is set to be thehighest priority for this fiscal year and will continue proactive investment.
More detail for VEOZAH is on the special feature pagePP. 49-51.

In large markets such as the US and Europe, continued growth is expected through market penetration of FLT3 testing in the market. In the International Markets, sales expansion is expectedfrom the increase of launched countries and reimbursement start.

52

VEOZAHInterview with Chief
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R&D Strategy Interview with Chief Medical Officer
stage and formulating development strategies that widen target diseases and indications for use

Under our new organization structure,
we work as One Astellas to accelerate
development toward the shared goal of
maximizing pipeline value.

in combination with other medications. Increasing investment at the early stages of development can be a risky business proposition due to insufficient data. At Astellas, though, we makedecisions by taking intelligent risks based on consideration of patient needs, scientific validity,
and preclinical data and so on.
* PoC: Proof of concept (key clinical data supporting a decision to initiate late-stage development)

Q

Tadaaki Taniguchi, M.D., Ph.D.
Chief Medical Officer (CMO)Q

Can you describe your impressions of Astellas upon joining, and detailthe aims of the organizational reforms?

Tell us of the response elicited by the current initiatives and describe thechallenges to be tackled next.

Members have started to set shared goals under our new organization, facilitating
collaboration within teams. Now, we seek to strengthen early-stage development
capabilities and step-up recruitment and training of global talent.

Under our Focus Area approach, Astellas continues to embrace the challenge ofcreating innovative new drugs. To further advance this, we aim to accelerateachievement of PoC through our new R&D operating model.

The biggest change I have seen so far is that the delegation to PF Leads of decisions on strategy,
budgeting, and order of priority has made them have a clear and positive awareness of their responsibilities within that PF more than before. Also, by clarifying the scope of responsibility for every single
member of each project team, we have ensured that all members of each Asset team have shared key
project objectives that transcend functional boundaries within the organization.
Organizational transformation also demands that employees shift their mindset toward
conducting business globally. As an organization from a business perspective, Astellas is focused on
maximizing pipeline value to achieve the goals set in Corporate Strategic Plan 2021. We have identified four critical elements such as new single R&D governance, appropriate team structures,supporting functions, and talents. My personal mission is to make progress on organizational transformation by thoroughly communicating the importance of these critical elements to oorganizations.
There are still two remaining challenges to address. The first one is strengthening our early-stage
development capabilities. This in turn involves speeding up new drug development by enhancing
our scientific expertise in new disease areas and updating development strategies even looking
beyond the post-PoC stage. The second challenge is to develop and recruit global talents andexpertise. Our objective is to become a truly global organization by accelerating talent development and hiring external talents not only in Japan and the US, but also in Europe, Asia, and otherregions. Building up our scientific presence globally is essential to attract talented individuals
around the world to aspire to, as well as continue to, work for Astellas. We continue to address thesechallenges ahead, to maximize pipeline value and deliver innovative new medicines to patients.

Prior to joining Astellas, I was trained as a surgical oncologist, and then have been working in major
global pharmaceutical companies for more than 22 years. I was struck by Astellas’ unique R&D strategy
and transformation of its pipeline. In the past 10 years, Astellas has rapidly expanded its target disease
horizons to include cancer and rare diseases, etc. For example, under our Focus Area approach,Astellas has undertaken a dramatic shift toward working with multiple modalities, including genetherapy, cell therapy, and protein degraders alongside small molecules and antibody drugs.
To accelerate new drug development through the Focus Area approach, I believe we must
thoroughly choose right modalities to focus on, develop greater scientific expertise, and leverage withnew ideas by strengthening our external networks. In April 2023, we radically transformed our R&D
organization. The primary objective of our “new R&D operating model” is to speed up development
projects and accelerate PoC* achievement. By empowering each Primary Focus (PF) and Asset teamand shifting the initiatives of activities from the function axis to the project axis, we have enabledagile decision-making. Also, while Astellas has an abundance of knowledgeable and experienced
individuals with an even higher degree of specialization are required to tackle these new areas.
To that end, we have created multiple functions and organizations focused on specialized fields.
I also see scope for Astellas to engage more in product life-cycle management. I think it ispossible to further enhance product value by identifying unmet medical needs from an early53

Astellas Pharma Inc. Integrated Report 2023

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R&D Strategy Areas of Interest
Focus Area Approach

Primary Focus

Focus Area approach is designed to identify

Genetic Regulation

drug discovery opportunities flexibly andefficiently by combining innovative biologies
and modalities/technologies to address
diseases with high unmet medical needs.

Modality/
Technology

Biologygene-based therapies.

Versatile technology

Pathophysiologycharacterized

Primary Focus is a specific focal point

The mission is to discover, develop and deliver meaningful
Our mission for Primary Focus Genetic Regulation is to discover, develop and deliver transformative genebased therapies for patients with genetic diseases. Genetic deficiencies cause almost 7,000 different diseases
and contribute also to the pathophysiology of many common conditions. By targeting disease at the genetic

Diseasewithin our Focus Area approach where leadand follow-on projects show a clear R&D pathlevel, we have the potential to develop life-changing therapies for patients who currently have limited or no

Disease with high unmet
medical needs

with expected VALUE for patients. Based on

effective treatment options.
One of our programs in development is AT132, a gene therapy for X-linked myotubular myopathy (XLMTM)

criteria such as higher scientific validity andthat is now in Phase II stage. In 2021, the FDA* placed a clinical hold on the trial after serious adverse events.

identification of leads and follow-on programs, we are currently working on five Primary Focuses:

We are working hard towards resumption of this clinical trial. Another gene therapy program, AT845, is in a

Blindness & Regeneration, Mitochondria, Genetic Regulation, Immuno-Oncology, and Targeted

Phase I stage for the treatment of Pompe disease.. We also have multiple programs at the research stage.
We are collaborating with world-renowned academic and industry partners to overcome the complex

Protein Degradation. We also identify the combination of biologies, modalities/technologies,

challenges of gene therapy research and development.

and diseases that may become Primary Focuses in the future.

* FDA: U.S. Food and Drug Administration

Primary Focus

Immuno-Oncology

Primary Focus Candidate
Immune Homeostasis
Targeted Therapeutics for Auditory
Regeneration
Autophagy
Bispecific Immune Cell Engager
Engineered Phage Therapy

The mission is to discover, develop and deliver the best innovative cancer

Genetic Regulation

Exploratory Research

Immuno-Oncology

medicines to patients and ultimately cure cancer.

Blindness &Regeneration

In our Primary Focus Immuno-Oncology, our mission is to provide cancer patients with innovative medicinesthat potentially could cure them. Only about 20% of cancers respond to existing immuno-oncology treat-

Mitochondria

ments. Our goal is to turn that 20% into 100% by activating and enhancing the immune system in new andTargeted Protein
Degradation

multiple ways, thereby reinvigorating its ability to discover, disarm and destroy more cancers in more patients.
Currently, we have four immuno-oncology programs in Phase I clinical trials: a DGKζ inhibitor ASP1570,

Specific Treg
Direct Reprogramming(Transdifferentiation)and three bispecific immune cell engagers (ASP2138, ASP2074, and ASP1002). Other drug candidates in our
R&D portfolio include multiple modalities such as oncolytic viruses and cell therapies. Over the years, Astellas

Innate Immunity

has brought together a wealth of expertise and talent, and we are actively partnering with leading-edge

Cell Therapy

biotechnology companies and academia to further enhance these existing capabilities and grow our pipelineof innovative cancer treatments.

54

Astellas Pharma Inc. Integrated Report 2023

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R&D Strategy Areas of Interest

Blindness & Regeneration

Mitochondria

The mission is to free patients from the fear of vision loss, and offer the hope of

We are advancing innovative mitochondrial approaches to the treatment ofrecovery of lost sight.

diseases with high unmet medical needs.

Our mission for Primary Focus Blindness & Regeneration is to develop and deliver next-generation treatments to

Our mission for Primary Focus Mitochondria is to become the global leader in discovering, developing, andrestore sight for patients with eye diseases. By taking advantage of next-generation modalities represented bybringing to market mitochondria biology-based medicines that provide tangible VALUE to patients, clinicians, andcell therapy and gene therapy for patients with eye diseases at high risk of blindness, we seek to provide newhealthcare systems. Mitochondria are specialized organelles in cells that have their own maternally inherited DNA

treatment options to replace, preserve and restore the function of cells critical for vision.

(mtDNA). They play essential roles in energy production and in processes such as metabolism and cell signaling.

ASP7317, human embryonic stem cell-derived retinal pigment epithelial cells, is our lead program for

Mitochondrial dysfunction is associated with diseases of the kidneys, liver, muscles, central nervous system, eyes,

geographic atrophy secondary to age-related macular degeneration, and currently is in a Phase Ib clinical trial.

and ears. Many of these diseases have significant unmet medical needs, as they have few treatment options.

ASP2020, a universal donor cell-derived program, entered the pipeline recently as a new drug candidate at the

We are conducting a Phase II clinical trial investigating the selective PPARδ* modulator ASP0367 in primaryresearch stage. We believe universal donor cell technology could be a powerful tool for preventing immune

mitochondrial myopathies. Our objective is to enable the delivery of innovative new treatment options forrejection and realizing allogenic cell transplantation.

diseases associated with mitochondrial dysfunction, by pursuing development of novel cellular medicines

Astellas has been a global leader in the transplantation field, and we continue to engage in R&D with a strong

focusing on mitochondrial functions.

passion for delivering safer transplantation therapy to more patients.

* Peroxisome proliferator-activated receptor delta

Targeted Protein Degradation
Our aspiration is to deliver disruptive clinical benefit for selected cancer patients by inhibiting pathologic genomic signaling.
In our Primary Focus Targeted Protein Degradation, our mission is to use theability to access undruggable targets, are their permeability (they can pene-

innovative modality of protein degrader to access so-called “undruggable”

trate the cell membrane and blood-brain barrier), and their high degree oftargets and develop novel treatments for cancer and other diseases.

specificity to the target.

Only about 20% of disease-related proteins have active binding sites suitablefor inhibition by conventional small molecules. The remaining 80% haveshallow binding pockets and their function cannot be controlled sufficiently
by binding alone. The advantages of protein degraders, in addition to their

Our lead program, ASP3082, is currently in a Phase I clinical trial, and wehave multiple follow-up programs ongoing.
We will persist with R&D activities utilizing this Targeted Protein Degradation
technology, with a view to bringing innovative clinical benefits to patients.

55

Astellas Pharma Inc. Integrated Report 2023

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R&D Strategy Areas of Interest
FY2022 Progress in Focus Area Approach

Outlook for FY2023 onward

We advanced the evaluation of multiple projects but were unable to achieve any PoC* in FY2022.

In FY2023, we expect to restart dosing in the AT845 and ASP7317 clinical trials that were subject

On the other hand, two projects (ASP2074 and ASP1002) entered the clinical stage. Like ASP2138, which

to a suspension of patient enrolment. We also anticipate data readouts for the monotherapy

already had entered the clinical stage, ASP2074 and ASP1002 are bispecific immune cell engagers.

dose escalation part of ongoing Phase I trials of ASP1570, ASP2138, and ASP3082, which we

In this manner, we continue to generate new follow-up programs via our Focus Area approach.

expect to lead to PoC judgement in FY2024 or later. We furthermore plan to initiate clinical trials

Among projects that already have entered clinical trials, we have succeeded in dosing the firston a total of four programs from Primary Focuses Immuno-Oncology, Genetic Regulation, andsubject in Phase I trials investigating ASP2138, ASP2074, ASP1002, and ASP3082 in cancer patients.

Targeted Protein Degradation.

We have suspended patient enrolment in a Phase Ib clinical trial of ASP7317 due to a manufac-

Our goal is to build a robust post-PoC portfolio from our Primary Focus pipeline by the end

turing delay, but were able to resume the trial after establishing capabilities enabling supply ofof FY2025. Based on advances made in FY2022 and planned progress in FY2023 onward, we arecells that meet high quality standards.

aiming for PoC judgements on a total of sixteen projects by the end of FY2025. To accelerate

In addition, seven programs at the research stage advanced to the late phase as new drug

PoC judgement for these projects, we deployed a new R&D operating model in April 2023.

candidates, to prepare for clinical trials.

For details, please see Major Pipeline on

PP.96-98* PoC: Proof of concept (key clinical data supporting a decision to initiate late-stage development)

TOPICS
New R&D Operating Model

Kachi Committee

In FY2021, we modified our research organization from a function-led and hierarchical structure to an objective-• Cross-Primary Focus (PF) / cross-project prioritization• Decision making focusing on key development milestones
Chaired by CxOs

Empower PFs and projects

based, agile organization. This transformation already is yielding outcomes including the creation of new
MedicalPrimary Focuses (PFs) and projects. We have since expanded this concept to include clinical development andResearch

Tech

Financeshifted the main basis of the activities from the function/division axis to the PF/project axis, enabling agile

Clin Ope···
PF Leadership TeamPF Lead• PF strategy development &execution• Budget management in placeof divisions

decision-making through team empowerment.
We set up a leadership team in each PF which is in charge of strategic planning, budget management, and
PF/Projectproject oversight and prioritization. We also reformed the organizational structure to reduce the number ofProject Lead
Project Teamlayers between each project lead and Chief x Officer (CxO), delegating day-to-day decision-making for each

• Project strategy development& execution• Day-to-day decisions withinproject

project to the project team.
…

At the corporate level, we established a new governance body called Kachi Committee. Chaired by CxO,
the Kachi Committee is responsible for prioritizing/deprioritizing PFs and decision-making focusing on key
development milestones. By empowering projects and PFs, we have reduced the need for visiting corporate

Function/Division

governance bodies and facilitated agile decision-making on a project-by-project basis. In this manner, we
aspire to achieve meaningful PoC as early as possible.

56

Agile decision making

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TOPICStargeted drugs generally regulate the function of proteins, protein degraders selectively degrade the target

Targeted Protein Degradation

protein and therefore are expected to demonstrate greater efficacy than conventional synthetic drugs.
Protein degraders also retain the advantages of small molecules, including the possibility of systemic

Targeted Protein Degradation as New Primary Focus(including oral) administration, and potential for applying established methods and expertise to manufacturing processes and regulatory compliance.

In October 2022, we selected Targeted Protein Degradation as a new Primary Focus. We aim to generate

We believe this technology can be applied to various targets through substitution of target protein binding

novel protein degraders that work by hijacking the body’s natural protein degradation process, the ubiquitinproteasome system, allowing access to undruggable targets that have proven difficult to address usingsites. Moreover, we think that by modifying E3 ligase binding sites and linkers, we can enhance functions such

conventional small molecules. We will proactively invest resources in leveraging our proprietary technology

as degradation efficacy and tissue specificity. We believe that this new modality could become an innovative

platform to continuously create programs in oncology and also non-oncology fields.

therapeutic tool, and we aim to continue creating programs that address previously undruggable target
proteins, either by substituting the target or further enhancing functions.

New Era of Synthetic Drugs

A protein degrader works by hijacking the body’s natural protein degradation process,the ubiquitin-proteasome system

Regulating disease-related proteins is a key approach to develop effective drugs. While many drugs havebeen produced by chemical synthesis, it was thought that conventional approaches would only be able to

PROTEIN DEGRADER

target about 20% of disease-related proteins. Conventional synthetic drugs are designed to bind to thepockets of disease-related proteins and control their functions. However, roughly 80% of disease-related

A protein degrader consists of a protein binder, an E3 ligase binder and a linker
connecting the two
Protein degraders catalyze the ubiquitination process. They do not need potent
binding affinity to the targeted protein

proteins do not have deep enough pockets for synthetic drugs to bind to and adequately regulate theirfunctions. These proteins historically have been regarded as “undruggable” targets. At Astellas, though,we have identified Targeted Protein Degradation as a novel approach to addressing undruggable targets andUbiquitinpositioned this as a new Primary Focus, making it a priority endeavor. Protein degraders constitute a newmodality, utilizing a process naturally occurring in the body to induce protein degradation.

Protein ofinterest

A protein degrader consists of a target protein binder, an E3 ligase binder, and a linker connecting the two.

Proteasome

E3

A protein degrader promotes polyubiquitination of target proteins by inducing proximity between target
proteins and ubiquitin ligases. Polyubiquitin serves as a recognition signal marking proteins for degradation via

Degradation

intracellular proteasomes. Protein degraders do not necessarily require deep binding pockets when inducing
proximity between the target protein and ubiquitin ligase, and therefore can be applied to a wider range of

The protein degrader brings the target protein and E3 ligase
adjacent where a ubiquitin “marked for destruction” tag is
added to targeted protein

target proteins historically undruggable. Also, because protein degraders catalyze the polyubiquitination
process rather than binding to the targeted protein and directly inhibiting its functions, they do not need thepotent binding affinity required of conventional small molecule drugs. Furthermore, whereas molecular57

The tagged protein is degraded, andthe protein degrader is released torepeat the processAstellas Pharma Inc. Integrated Report 2023

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TOPICS
Unprecedented speed in R&D for lead program ASP3082

Modified
Organization Structure

Achievement from New Research
Organization Structure

Function-Led/Hierarchical

On-Site Decision-Making

Our lead program, ASP3082, is a potentially first-in-class KRAS G12D degrader that is progressing through R&D
at a speed unprecedented for Astellas. KRAS is a prime example of protein targets previously deemed
undruggable, with a key role to play in cell proliferation. KRAS mutations can cause the cellular switch to stay

Drug Discovery
Research Headin the ‘on’ position, allowing cells to grow uncontrollably and give rise to tumor growth. Our interest in thisarea began in the 2010s, when we commenced research aimed at discovering conventional KRAS mutant

Pharmacology

inhibitors. It proved technically difficult to create compounds that would bind selectively to KRAS mutations

Chemical
synthesis

Safety, etc.

such as G12D, but we were able to identify proprietary KRAS mutant binders by leveraging our historical small
molecule capabilities. However, these compounds failed to demonstrate sufficient tumor-suppressing effect.

Objective-Based/Agile

Independently from this inhibitor research, we also initiated protein degrader research in the 2010s, building

Timely Investment Decisions
by Top Research Executives

Cultural and Behavioral
Transformation

various technologies for drug discovery via this modality. In 2020, we combined these two streams ofresearch and began investigating KRAS G12D degraders. In just the fifth month after commencing thisresearch, we identified ASP3082. Furthermore, we were able to submit an Investigational New Drug (IND)
application a mere 12 months after selecting ASP3082 as a new drug candidate.

Organizational culture to create innovation from researchers’ ideas

Outlook going forward

We believe this unprecedented speed of development was made possible by Astellas’ agile research

We believe that Targeted Protein Degradation is a promising technology that will revolutionize the field oforganization. We modified our research organization in 2021, transitioning from a traditional, function-led

synthetic drugs and usher in a new era. In terms of our strategy, the goal in the first wave is to bring ahierarchical structure to an objective-based, agile organization. Within this organization, we formed a team

KRAS-targeted protein degrader to market. In addition to the G12D mutation-targeting ASP3082, we havededicated to researching targeted protein degraders, assigning researchers with the expertise and leaving

other programs targeting different KRAS mutations. In the second wave, we seek to utilize both proprietarydecision-making in the hands of the department head with strong leadership. Under our previous researchtechnologies and novel external technologies to expand our reach to oncology targets other than KRAS andmodel, implementing an idea could take a long time owing to the multiple steps involved. In our new flatpromote the creation of protein degraders harnessing next-generation technology. In the third wave, we aimorganization, though, researchers can voice original ideas and put forward ambitious plans. In fact, the break-to expand our horizons further to include targets related to diseases other than cancer—for example,

throughs made in the process of creating ASP3082 stemmed from proposals and decisions made on-site inimmunological diseases. Since the technology is based on synthetic drugs, we believe we can leverage its

the laboratory, rather than top-down approach. In this manner, leadership encouragement is bringing

accumulated knowledge and experience in this field to its advantage. Moreover, we have many experts inresearchers’ ideas to life and encouraging R&D across the organization, resulting in creation of new drug

the area of synthetic drugs. We plan to proactively leverage the strengths of our external partners while

candidates in record time. This cultural and mindset change has spilled over from research to our manufac-

harnessing the expertise of each researcher through our flexible organizational structure. By doing so,turing and development divisions, quickly establishing a platform for cross-departmental collaboration.

we aim to lead the industry with protein degraders and use this technology to create VALUE for patients.

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DX Strategy
Astellas’ approach to DX is much more than simply streamlining operations through digital technology.
We are implementing DX to realize our VISION “On the forefront of healthcare change to turn innovative science into VALUE for patients.”
Aims of our digital transformation (DX) initiatives

Maximizing VALUE by organically connecting all kinds of data from management

In the pharmaceutical industry, the drug development process usually is a lengthy 10–20 years,

decisions to individual projects

entailing huge investment in the range of 10–100 billion yen. The probability of success moreoveris extremely low at around one in 10,000 to 30,000, and there is risk in the meantime of scientific

Corporate
Dev, Commercial

Monitoring achievement ofeach goal to achieve Corporate
Strategic Plan 2021

advances derailing existing hypotheses, or of significant change in target patient numbers orsocietal conditions. Pharmaceutical manufacturing accordingly is a business characterized by highCorporate

Capturing Real Needs that Lead to
VALUE through Social Listening

Portfolio Managementlevels of uncertainty, requiring extremely difficult decisions about what to invest in and when.
VISION

Astellas aims to create innovative pharmaceuticals through our Focus Area approach.

Commercial
Leveraging RWD to Model Patient
Journeys and Forecast Marketability

On the forefront of healthcare

Inevitably, taking this kind of approach means challenging the areas where conventional experi-change to turn innovativeence and knowledge cannot be directly applied, and where predictions are difficult to makescience into VALUE for patients

Outcomebased on the data we have in hand. We accordingly have used a hypothesis-oriented simulation
approach in addition to usual data-driven approach. The simulation approach helps us test
decision-making by generating possible outcomes of the decisions based on available data andassumptions such as a project’s probability of success, clinical trial duration and market needs.
We think the approach helps us further improve decision-making by allowing us to deal with ahigh degree of uncertainty.
At Astellas, we utilize analytics in all areas of our enterprise to maximize VALUE. In the exhibit

Input

Business Activity

OutputFinancial capital
Manufacturing
capitalIntellectual capitalSocial and
Relational capital
Human capital
Natural capital

Strategy:
Corporate Strategic Plan 2021

XTANDI and Priority

VALUE

Primary Focus
Project

Talent and Organization

Outcomes

Strategic Products

Portfolio

VALUE=

Products derived
from Focus Area
approachthat matter to patients

Cost
to the healthcare system ofdelivering those outcomes

below, we illustrate some examples, one being the initiative “Calculating VALUE based on RWD*
and Selecting Optimal Indications,” which we use to determine which indication or indications
will yield the highest VALUE for a product (“output”). Similarly, with the initiative “Insights into
Innovative Organizational Structures through the Use and Analysis of Human Resources Data,”
we take “Human Capital,” which is “Input” and “Talent and Organization” on the “Business Activity”
and apply the power of analytics to improve upon the current situation and maximize VALUE.
* RWD: Real World Data: Medical big data comprising a collection of information based on medical practices obtained in clinical settings.

Corporate

Marketing

Dev

Providing Information thatContributes to Investment Decisions
with Limited Data

Marketing Strategies Based on
Long-term Sales Forecasts

Utilizing RWE to Expand Indications
without Clinical Trials

HR

Tech

Dev

Insights into Innovative Organizational
Structures through the Use andAnalysis of Human Resources Data

Demand Analysis for Stable Supplyof Products

Calculating VALUE based on RWD
and Selecting Optimal Indications

Data-driven
Data-driven + Simulation

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Corporate Strategic Plan for
Value Creation

Value Creation Story

Strengthen Foundation
for Value Creation

Corporate Data

DX Strategy
Voice

Case

Astellas is advancing DX by performing advanced data analysis and utilizing machine learning,

Monitoring progress toward each goal set in Corporate Strategic
Plan 2021 (CSP2021)

AI, and other digital capabilities.
For Astellas, creating innovative medicines through our Focus Area approach means venturing
into areas that are beyond the scope of our previous experience and expertise.

In order to achieve the Strategic Goals laid out in CSP2021, Astellas has many projects in train. Most of

In settings where strategic decision-making is required, there are instances in which historicalthese projects are cross-functional and thus require multiple departments to work together. While data

data is not enough to make informed decision. We therefore are taking a vastly different approachon the progress of each project is centrally managed, the sheer volume of information is such that it has

to those premised on historical data.

not been possible to gauge progress and expenditure at a glance. Nor has there been any mechanism forFirst, we use available data, information, theories, and findings to build the best-possible

real-time analysis of circumstances and generation of insights that could inform management strategy.

hypotheses on subjects such as probability of development success, the time required for

As a solution to this problem, we have developed a dashboard to support strategic decision-making

development, market needs, and so forth. Next, based on those hypotheses, we look at futureby automating the analysis and processing of these huge amounts of data. This has enabled visualization

scenarios for opportunities and risks (for example the development status of competingof progress in the initiatives tied to each Strategic Goal, enabling prioritization of critical information andproducts). We represent these scenarios mathematically andextraction of trends. As a result, we have managed to reduce the time required from data entry to visual-perform simulations to help decision makers identify the best

ization from three days to 15 minutes. We are utilizing the time thus saved to formulate strategic insights.

option for improving the VALUE we create. In other words, in generDashboard (Image)ating possible outcomes and scenarios that inform and support
strategic decision-making, we use the simulation-based approach

The graph at top shows the number of reports

combined with the hypothesis building.

generated on each goal set in CSP2021. The exhibit

Masanori Itosize of each box an indication of report numbers.

at bottom is a visualization of this data, with the
Colors correspond to the importance assigned to

Digital, Analytics and Technology – Enterprise Insights and Digital Solutions

each objective.

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Interview with Chief
Executive Officer

Astellas Pharma Inc. Integrated Report 2023

Corporate Strategic Plan for
Value Creation

Value Creation Story

Strengthen Foundation
for Value Creation

Corporate Data

Sustainability Strategy Interview with the Head of the Sustainability Division

Q

Making steady progress toward Strategic Goal 4
through a combination of sustainability initiatives
focused on key issues, and advocacy activities
promoting understanding of these initiatives amonginternal and external stakeholders

We established a new Sustainability Direction and are now in the process of executing“Our Commitments by FY2025”
In FY2022, the establishment of a new Sustainability Direction constituted a major step towardachieving Strategic Goal 4*3. A Sustainability Direction already existed but was created in theprocess of revisions to our Materiality Matrix. In formulating a new Sustainability Direction,
we focused on the nine material issues (Materiality) as well as the two environmental issues
identified as being of greatest concern to society. A cross-functional team then defined “Mid-term
Priorities for Astellas,” “Initiatives,” and “Our Commitments by FY2025,” which were submitted forreview by the Executive Committee and Board of Directors, and then finalized. In establishing thisSustainability Direction, we maintained a keen awareness of the Organizational Health Goals set
in CSP2021, with a view to defining ambitious rather than easily achievable goals.
In addition to establishing a Sustainability Direction, we also made progress in pursuing eachof our Materiality initiatives. In improving Access to Health, for example, we began to provide
countries with unmet needs in the cancer healthcare system support, one of the diseases
targeted under our Primary Focus approach. In response to the latest Access to Medicines Index(ATMI)*4 Report, which identified a lack of transparency in Astellas’ equitable access strategies,
we created an entirely new mechanism and strategy for access to medicine. I take great pride in
Astellas’ creation of a comprehensive Access to Medicines strategy and a playbook to drive
execution, going beyond the mere provision of economic support for organizations dedicated to
improving access to medicines.
In terms of environmental initiatives, we met our FY2030 GHG*5 emissions reduction target
early, in FY2021, and received approval from the SBT*6 Initiative to set new targets. Furthermore,
we announced our commitment to achieving net zero GHG emissions by 2050. Finally, with aneye to realizing resilient and sustainable business operations, we began to consider BCP
measures against risks such as regional conflicts and electricity shortages, and we are now in theprocess of planning a system for maintaining stable supply.

Shingo Iino
Vice President, Sustainability

Q

Please describe progress toward achieving Strategic Goal 4, and the outlook going forward.

Tell us about Astellas’ stance on sustainability, and the level of understanding amonginternal and external stakeholders.

For Astellas, sustainability is the essence of our business activities.
Thus, the concept is steadily gaining traction among stakeholders.
For Astellas, sustainability is by no means a new concept, but rather an extension of Astellas’business activities. In short, we think that our very operations contribute to sustainability for bothsociety and Astellas. When we talk of Astellas and its approach to sustainability, first and foremost
we think it’s important to promote deeper understanding of this tenet among our stakeholders(both internally and externally).
In FY2021, we revised our Materiality Matrix that guides our sustainability efforts*1. Each of theissues identified is strongly associated with our existing operations but at the same time cannot
be linked solely to a single business division. We therefore think it’s essential that each employee
at Astellas understands our material issues and key issues.
In FY2022, we proceeded to strengthen our advocacy activities on sustainability. We utilized arange of media to promote understanding of our sustainability activities among both internal andexternal stakeholders. Internally, we sought to replace one-way communication with dialog-based
communication, using Ask Me Anything*2 sessions and division- or group-level small meetings todeepen stakeholder understanding via interactive communication. Through our global engagement survey, we know that employees have indeed developed a greater understanding ofsustainability, attesting to gradual penetration of the concept throughout Astellas.
In February 2023, we held our second Sustainability Meeting to apprise external stakeholdersof the progress we are making with sustainability activities. We have remained proactive in disseminating information about our sustainability initiatives, including via frequent dialog with investors.

*1 For details, please refer to

P. 20.

*2 Ask Me Anything: Large interactive sessions designed to promote two-way communication between management and all.
*3 Deepen our engagement in sustainability.
*4 ATM Index: The Access to Medicine Index assesses and ranks the efforts of pharmaceutical companies in addressing access to medicines indeveloping countries.
*5 GHG: Greenhouse gases.
*6 Greenhouse gas emission reduction targets set by companies 5–15 years ahead, consistent with levels required by the Paris Agreement.

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Astellas Pharma Inc. Integrated Report 2023

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Corporate Strategic Plan for
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Value Creation Story

Strengthen Foundation
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Corporate Data

Sustainability Strategy Initiatives for Contribution to Sustainability
Astellas’ Sustainability

Sustainability Direction

Astellas recognizes that our contribution to

Astellas’ Interaction with Societysocial sustainability and earning trust fromEngage in the Sustainabilityof Societysociety will enhance Astellas’ sustainability.

Two Pillars for Evolving Sustainability

01 Transforming to be a Cutting-Edge, VALUE-driven
life science innovator

Trust from Society

Advisory Panel, and Environment, Social and

SUSTAINABILITY GOVERNANCE

Astellas

Governance Working Groups (E·S·G Working
Groups), all led by the Sustainability Divisionand consisting of cross-functional members.
These organizations promote the following
activities including Strategic Goal 4 for all
divisions to contribute to sustainability from along-term, strategic and groupwide perspective.

operations to meet the expectations of society

Environmental Sustainability

Society

We have established the Sustainability

02 Strengthening resilient and sustainable business

Fulfill our social responsibilities as a pharmaceuticalcompany

Executive Committee*1 / Board of Directors*1

Enhance the Sustainabilityof Astellas

Raison D’être

MissionContribute towards
Improving the Health ofPeople Around the Worldthrough the Provision of
Innovative and Reliable
Pharmaceutical Products

Sustainable Enhancementof Enterprise Value

President and CEO
Head of Sustainability division

Sustainability Advisory Panel• Oversee all Astellas’ Sustainability activities including
ESG*2 elements.

Discuss and consider global sustainability issues thatare overarching to ESG such as the change in the
Sustainability Direction.

• Decides on holding a Sustainability Advisory Panel.

Chair: Head of Sustainability division

Environment (E)WorkingGroup

Strategic Goal 4: Deepen our engagement in sustainability

Social (S)WorkingGroup

Governance (G)WorkingGroup• Discuss/exchange information on material issues on E, S or G,
respectively, and create Advocacy strategy.
• Report the outcome to Head of Sustainability.

— Improve “Access to Health”— Contribute to Environmental Sustainability with Greater Transparency

Oversight:
Head of Sustainability Center of Excellence*3— Advocate our Efforts on Sustainability

In FY2022, Astellas considered how our efforts to address the nine material issues (Materiality)*1 Sustainability annual plan and activities are required to be reported to
the Board of 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 oversightof Head of Sustainability division.

Two Pillars for Evolving Sustainability

would lead to improving corporate value, and summarized them as two pillars for evolving

01

sustainability. The first pillar “Transforming to be a cutting-edge VALUE-driven life science innovator”
is related to five of these material issues. The second pillar “Strengthening resilient and sustainablebusiness operations to meet the expectations of society” is related to the remaining four. Astellas has

Transforming to be a Cutting-Edge,
VALUE-driven life science innovator

The first pillar: Astellas will continue to create innovative healthcare solutions for unmet medicalalso established a sustainability direction as a guide toward FY2025 to address Materiality, as well as

needs, utilizing new modalities such as cell and gene therapy, while striving to ensure that thetwo important issues related to the environment that are pressed for by society. Astellas’

VALUE we create reaches the patients who need it most. In order to create innovative thera-sustainability initiatives will be promoted in line with this sustainability direction moving forward.

peutic methods continuously, appropriate price setting is necessary for innovation.

The following pages describe more detailed information including concrete initiatives.

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Corporate Strategic Plan for
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Corporate Data

Sustainability Strategy Initiatives for Contribution to Sustainability
Astellas will also work to create an environment and mechanisms to ensure that prices fairly
reflect the impact on society, including patients, their families, and the healthcare professionals

medical care, including diagnostic, preventive,

Astellas’ Core Businesstherapeutic and prognostic care).

approx. 143 million patients

who support patients’ health.
We believe that one of the most important
driving forces for creating and delivering significant value to societies is an organizational
culture that generates innovation. Thus, we will
work to foster such an organizational culture at
Astellas and acquire and develop people thatwill contribute to the creation of innovation.

103 countries

were prescribed Astellas products cumulatively up to the firsthalf of FY2022

2. Enhancing availability of Astellas products

Relationship to Material Issues and Key Issues• Access to Health• Talent and organizational culture for realizing
innovation• Fulfilling unmet medical needs by creating novel
healthcare solutions• Transformative treatment through innovative therapeutic methods• Value-based pricing

For patients who are unable to obtain Astellas medicines for social or economic reasons, we strategically implement activities to improve access to our pharmaceutical products from the development stage to post-launch.
For patients who are unable to participate in clinical trials but meet certain criteria, our Early Access
Programs provide access to investigational therapy for patients with serious or life-threatening diseases who
are unable to participate in clinical trials and have exhausted existing treatment options. For example,
through the PADCEV Early Access Program, more than 1,400 early access requests have been approved forpatients with locally advanced or metastatic urothelial cancer in 7 countries. Our International Pharmacy

Improving Access to Health: Our Initiatives

Program (IPP) allows products that have already been approved in major countries to be imported and usedin countries not yet approved for eligible patients. Through this program, in the most recent year, PADCEV has

Astellas recognizes Access to Health as a material issue, and through our VISION to be “On the fore-

now been imported into 17 countries. Over the life of the program, the IPP for PADCEV has served more thanfront of healthcare change to turn innovative science into VALUE for patients,” we proactively take a

50 patients. In addition, our Patient Access Initiatives (PAI) are active in 25 countries. These PAIs are programs

comprehensive approach to addressing this issue through the three methods defined below.

that help eligible patients obtain affordable access to Astellas products either directly or through Governments,
Healthcare System Agencies or other eligible organizations.

Astellas’ initiatives improving Access to Health

We continued to build the capability to implement data and evidence-based pricing solutions for ourinnovative products. These solutions ensure that payers and healthcare systems pay a fair and value-based

1. Astellas’ core business (Rx, Rx+)
Rx, Rx+price for our newly launched medicines.

2. Enhancing availability of Astellas products

EARLY ACCESS REQUESTS
3. Collaboration and support for the activities implemented byexternal partners to improve Access to Health

1. Astellas’ core business (Rx, Rx+)

INTERNATIONAL PHARMACY PROGRAM (IPP)

900+ patients

1,400+ early
access requests

40+
countries

continued to receive early access totherapy in FY2022

cumulatively for XOSPATA and PADCEV
have been approved

50+ patients

have received therapy since initiationof the IPP for PADCEV in May 2021 thatprovides access to certain products

Since our establishment, Astellas has continuously strived to create innovative healthcare solutions and

PATIENT ACCESS INITIATIVESPOST-TRIAL ACCESS

deliver them to patients who need them. We will accelerate our research and development based on our

45+ active patient access 30+ countries
initiatives

150+ oncology patientsto date in FY2022 that provide access for certain products after
approval and before reimbursement, and primarily, after commercial
availability in a country through various affordability programs called
patient access initiatives

continued on treatment with post-trial access to Astellas products(continued course of therapy following the end of a clinical trial given
the patient is showing continued benefit)

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 knowledgeof 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

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25+ countries

Interview with Chief
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Astellas Pharma Inc. Integrated Report 2023

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Access to Medicines Operational Oversight Committee in FY2022 to bring together leads from each access

3. Collaboration and support for the activities implemented by external partners to improve
Access to Healthprogram to ensure training is provided, processes are kept up to date, and proper reporting occurs. While stream-

In our efforts to improve access to health, we strive to provide cooperation and support for the activities

lined processes and cross-functional collaboration are vital, the passion and dedication of the Astellas team will

implemented by external partners by combining our capabilities and technologies.

Astellas is committed to rising to the challenge to ensure the sustainability of its programs. We established thebring about success. What you will find at Astellas is a team truly committed to bringing access to health forAstellas continues joint research with Medicines for Malaria Venture and TCG LIFESCIENCE (TCGLS) for thepatients. As the most important materiality for both society and Astellas, we will contribute to improve ATH as

exploration of novel antimalarial drug molecules with potential for further development.

One Astellas.

Together with a consortium of partners, Astellas has contributed by leveraging our formulation technologies andEnhancing Availability of Astellas Products

know-how to developing a potential new pediatric treatment option, arpraziquantel, for schistosomiasis in

Clinical Development

Market Authorization

Commercializationpreschool-aged children. In December 2022, European Medicines Agency (EMA) has validated the regulatory application for arpraziquantel and has started its review process.

Clinical Trial Programs

In the areas of strengthening healthcare systems and improving health literacy, we are funding new

Early Access Program
Post-trial Access Program

projects with non-governmental organizations to impact society where expects synergy with Astellas’

International Pharmacy Program (IPP) & International Import Program (IIP)

current/future business activity.
Astellas focuses on supporting and collaborating with external partners: National Cancer Society Malaysia andPatient Access Initiatives

Asia Cancer Forum, Japan, City Cancer Challenge Foundation (C/Can), Peru, Academic Model Providing Access toEnhancing the literacy of healthcare professionals and patients through academic and patient societies

Healthcare (AMPATH), Mexico and MAP International, Dominican Republic, to remove barriers to healthcare andVoicestrengthen health systems. The programs are focused on cancer care. Funding from Astellas is intended to help
strengthen healthcare systems and health literacy in countries where the company has a business presence.

We realize that some patients with life-threatening diseases may not be eligible for clinical trials andmay have exhausted their treatment options.
This is when early access programs become important. We established a centralized Early Access

Health System Strengthening Program (Malaysia and Peru. Mexico and Dominican Republic are newly added FY2023)

function at Astellas in 2020, which shows how seriously the company views these programs and thevalue they bring to patients. Astellas can receive a physician’s request for early access at any time,nearly $3 million

4 global charitable donations

from any country. For this reason, we established processes to ensure that all early access requests are

1.2 million people

PATIENT CENTRICITY PROGRAMS

evaluated quickly and consistently.
Astellas also realizes the importance of ongoing access to therapy for patients with life-threatening
diseases who complete our clinical trials. Post-trial access programs bring value to patients who
receive uninterrupted access to therapy until a product is commercially available.

20+ patient advocacy/patient organization programs supported

20+ million individuals

in 2022 to understand and address what truly matters to patients

projected to be impacted

Starlight Partner Activities*

49 people (36 organizations)

Early access and post-trial access programs are just two
ways that Astellas helps patients with life-threatening

participated in Peer support training

diseases overcome availability challenges. These programs

Ramona Rorig

demonstrate that we remain committed to improving

Business Operations
Lead, Early Access

access to Astellas products.

More than

expected to be impacted

12 people (10 organizations)participated in Leadership Training Program

1 people (1 organizations)participated in Patient Expert Program* Activities that support the self-reliance and sustainable development of patient organizations. For details, please visit the following website:
https://www.astellas.com/en/sustainability/enrich-the-lives-of-patients64Astellas Pharma Inc. Integrated Report 2023

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Sustainability Strategy Initiatives for Contribution to Sustainability
Strengthening Business Continuity Plan (BCP) for Geopolitical Risks & Natural Disasters

The Astellas Foundation for Research on Metabolic Disorders (AFRMD)* contributes to
medical and life sciences through the discovery and nurturing of brilliant young talent andAstellas is strengthening its BCP measures against unpredictable risks such as regional conflicts andsupport for researchers by providing training and an opportunity to study abroad. Describednatural disasters and is preparing for supply chain disruption, energy shortages, and rising energy

below, the Astellas Global Health Foundation primarily funds initiatives to support the mostcosts. Specifically, in preparation for supply chain disruption, we adjust inventory levels to maintainunderserved communities in low- and middle-income countries where Astellas does not have a

a stable supply according to risk levels. In addition, we have secured secondary suppliers andbusiness presence. Both the AFRMD and AGHF operate independently of the corporation.

secondary sites for many of our global products. To reduce energy-related risks, we are working on* For details, please visit the following website:
https://www.astellas.com/en/sustainability/advancement-of-medical-sciences

the introduction of solar power generation, introducing backup power supplies for manufacturing
and research sites in Japan, and setting up emergency power supplies. By recognizing and

The Astellas Global Health Foundation

preparing for unpredictable risks, we will maintain a stable supply of pharmaceuticals, which is our

The Astellas Global Health Foundation (AGHF) is an international philanthropic organization dedicated to supporting 3 key
areas: improving access to health – Neglected Tropical Diseases/Communicable Diseases, Mental Health and Children’s
Health, building resilient communities, and providing disaster preparedness support in underserved global communities.
Launched in 2018, the Foundation has awarded $11 million in grants to support charitable initiatives focused on
improving access to health, building resilient communities and providing disaster support. Through the funding, it isanticipated that the AGHF will impact more than 35 million lives over the next three years in Kenya, Nepal, Dominican
Republic, South Sudan, the Democratic Republic of the Congo, Ghana, Ethiopia, Nigeria, El Salvador, Honduras, Uganda,
Senegal, Guinea Bissau and Venezuela.

mission as a pharmaceutical company, and will realize a flexible and sustainable business.

From regional
conflicts and natural
disasters• Supply chain
disruption• Energy shortage• Rising energy costs

Two Pillars for Evolving Sustainability

02

Strengthening resilient and sustainable business operations tomeet the expectations of society

The second pillar: Astellas will build a robust system throughout our supply chain to manufacunder any circumstances. In addition, we will continue to provide information to ensure that

EnergyProcurement

Securing electric power in case of a power outage• Set up emergency power supplies for refrigerators containing important drug substances and stored products• Introduce backup power supplies for manufacturing and researchsites in Japan

harmony between the global environment and our business activities is a prerequisite to our corpo-

of society by continuously working in an ethical manner, considering what health care solutions

Supply Chain activities.

Response to power shortages and high costs• Currently considering the introduction of solar power to reduceenergy risks

companies are required to be actively involved in such environmental issues. Recognizing thatance with laws and regulations in all our business activities. We will respond to the expectations

we would like to introduce our Responsible

Response to supply chain risks• Inventory management for a stable supply• Secure secondary suppliers and sites, and make efforts to secure themin as short a time as possible

These two important issues related to the environment are being pressed for by society and so

Astellas products are used appropriately by patients and will ensure we work in strict compli-

ucts can contribute to patients. In this report,

Manufacturing
Supply Chain

Environmental Sustainability

ture products of superior quality to global standards and deliver highly safe products to patientsare best for patients and what Astellas prod-

Risk Control

Risks

rate existence, we shall take proactive measures to conserve the global environment. In addition to

Relationship to Material Issues and Key Issues

the nine material issues, we will also promote• Compliance and ethical business practices• Product quality assurance and product safety• Responsible supply chain management• Safe and appropriate use of products

initiatives for these two important issues.

65

Relationship to Material Issues and Key Issues• Reduction of environmental burden• Climate change and energy

Interview with Chief
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Astellas Pharma Inc. Integrated Report 2023

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Disclosure based on TCFD recommendations
An in-house cross-functional team for disclosures was established to conduct a scenario analysis. The team analyzed Astellas’ business and climate-related risks and opportunities, on the assumption thattransition risks would materialize under a 1.5°C scenario for climate change and physical risks would materialize under a 4°C scenario. A qualitative risk/opportunity analysis was conducted in the FY2021
review. In FY2022, the team conducted a quantitative analysis on some items. As the GHG emission reduction action plan changed from a 2°C target to a 1.5°C target in terms of temperature increase thetransition risk scenario was also changed to a scenario that assumes global temperatures rise by 1.5°C. The results of the analysis were reviewed by the EHS Committee.
Analysis of Risk and Opportunities*
Climate-Related Risks

Potential Impacts

Financial Impacts

Transition Risks (risk materializing at 1.5°C increase)
Business sites that have not introduced renewable
Increased pricing of
GHG emissions (costs energies may have to add payment of a carbon
tax to their costs.
if paying a carbon
tax)

Affected Period

One billion yen in FY2030
assuming a carbon tax of $100
per tonMedium tolong-term

Policy and
Legal
Obsolescence andimpairment 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 beavailable in some countries after 2035.

Physical Risks (risk materializing at 4°C increase)• Operations halt at our business sites due toIncreased severity offloods or other factors.
extreme weather
events such as floods • Raw material and product supply is delayed due
Acuteto damage in the supply chain caused by floods
or other factors.

Climate-related opportunities
Resource
efficiency
Products
andmarkets• Use of more efficient production
and distribution processes• Use of recycling• Development and/or expansion of
low emission goods new products
and services• Access to new markets

Potential Financial
Impacts
Reduced operating
costs

Increased revenues
through access to newand emerging markets

No significant impact
Medium tolong-term

500 million yen* Referred to the flood countermeasures of the Toyama Technical Center.

Near tolong-term

Affected period
Near tolong-term

Near tolong-term

Astellas’ Resilience• Some of the electricity consumed at the business site is generated internally by using renewable energy sources
such as wind power and solar power.
• Switch to purchasing energy derived from renewable sources at business sites (part of manufacturing and researchsites 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 withthe purchase will be issues for consideration.
• There are no existing facilities that we are required to dispose of at this moment.
• Regarding freon gas, we will take appropriate measures that comply with laws and regulations.
• From 2030 onwards, we need to respond to a required change in automotive vehicles (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 business operations.
The following investment was planned for the Toyama Technical Center flood response and the investment amount
was estimated at 500 million yen.
• Install a 3m waterproof wall around the power receiving building• Construction of substation equipment with a structure of 3 m or more
• Purchase of generators
If similar measures are required, a similar amount of investment will be considered.
Astellas’ response• In order to maintain a stable supply of pharmaceuticals even during pandemic of infectious disease or natural disasters such as earthquakes, storms, and flooding,
three logistics centers are operated in Japan.
• 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.
• For the spread of infectious disease in endemic areas due to temperature change and the need for new drugs for infectious disease treatment assumed by the problemof antimicrobial resistance, collaboration with the phage biologics researches Course at a university to create engineered bacteriophages, could be a viable solution.
• Climate change can change the geography of the morbidity associated with and severity of epidemics. Heart disease, respiratory disease, etc., may also increase.

* Only some items were extracted from the analysis results. See the corporate website or EHS report for details.

https://www.astellas.com/en/sustainability/TCFD-disclosure
https://www.astellas.com/en/system/files/5ca463117e/ehs-report2023_en_final1.pdf

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Climate Change and Energy

Steps toward 2050
Back casting

Mitigating and adapting to the threat posed by climate change requires active involvement by

Science Based Targets (SBT) for Astellas

national governments, local governments, corporations, citizens, and others. Astellas recognizes thatclimate change will become a constraint on conducting sustained corporate activity, and considers it

Base year 2015

2018

2023

Target 2030

2050
Goal
for Society2030

an important management issue to address. Astellas has made a long-term commitment to taking
measures against climate change and decided to aim for achieving a 90% reduction in GHG emissions and a 10% neutralization of residual emissions to achieve net zero by 2050, based on 2015, for
Scope 1 and 2 and Scope 3, respectively. In addition, the Science Based Targets (SBT)* initiative
approved Astellas’ GHG emissions reduction targets through 2030. To address climate change as a

Environmental Action Plan (Climate Change Action)<SBT certified> (2°C target)

New Environmental Action Plan
(Climate Change Action) <SBT certified>• GHG emissions (Scope 1+2): 30% reduction by FY2030• GHG emissions (Scope 3): 20% reduction per sales revenue
by FY2030• GHG emissions (Scope 1+2):
63% reduction to 1.5°C Target by FY2030• GHG emissions (Scope 3):
Reduce by 37.5% by FY2030 to a level well
below 2°C

management issue, we have adopted as targets, the 1.5°C (Scope 1 and 2) and well-below 2°C(Scope 3) targets of the Paris Climate Agreement.

FY2021 Performance:• GHG emissions (Scope 1+2): approx. 41% reduction• GHG emissions (Scope 3): approx. 22% reduction per sales
revenue* Greenhouse gas emission reduction targets set by companies 5–15 years ahead, consistent with levels required by the Paris Agreement.

Progress on Environmental Action PlanOur Environmental Action Plan sets out short-term and medium-term targets for our activities regarding the• Achieve Net Zero GHG emissions by 2050

key points of the Astellas Environment, Health & Safety Guidelines. We renew our action plans on a rolling

Using Renewable Energy

basis, by reviewing progress and conditions during the previous year and incorporating our findings into our

The use of renewable energy is one of the most effective climate change countermeasures. Astellas is intro-

action plan for the following year.

ducing photovoltaic panels and wind power generation, and such equipment as biomass boilers, andProgress on Environmental Action Plan (Scope 1 + 2)

Our Environmental Action Plan sets out short-term
and medium-term targets for our activities regarding
the key points of the Astellas Environment, Health &

(%)
100
90

purchases electricity derived from renewable energy sources to reduce GHG emissions. We will continue toscope 1 + 2(V.S. FY2015 level)100

strive to expand the use of renewable energies to help achieve net zero.

80

Starting in April 2020, Astellas switched all electricity consumed by its three research and production sites in

Safety Guidelines. We renew our action plans on a

70

Japan (Tsukuba Research Center, Tsukuba Biotechnology Research Center and Takahagi Chemistry & Technology

rolling basis, by reviewing progress and conditions

60

during the previous year and incorporating our findings into our action plan for the following year.
Astellas will keep on conducting continuous

–39.0

–41.3

–41.8

Development Center) to hydroelectric power, which is free of GHG emissions. This enabled a reduction of emis-

50

sions of 37,133 tons. Moreover, we are also moving

40
30

2015

2020

2021

ahead on switching to electricity generated by2022 (FY)

renewable energy sources in areas outside of Japan.

reviews of investment plans related to matters such as introducing renewable energy.

Looking ahead, Astellas will continue to explore
opportunities for using renewable energy, and it will

Progress on Environmental Action Plan (Scope 3)
FY2015 (Base-year)

GHG emissions (Scope 3) (tons)
Improvement from Base-year (%)

453,181–

FY2020

FY2021

FY2022also consider formulating targets for the use of

268,118–40.8

313,005–30.9

445,007–1.80

renewable energy.

67

Wind
6 TJ
2%

Biomass(wood)
45 TJ
12%Total Renewable
Energy Consumption

387 TJ
in FY2022

Photovoltaic/
Geothermal
0.6 TJ
0.2%
Renewable
electricity
335 TJ
86%

Interview with Chief
Executive Officer

Astellas Pharma Inc. Integrated Report 2023

Corporate Strategic Plan for
Value Creation

Value Creation Story

Strengthen Foundation
for Value Creation

Corporate Data

Sustainability Strategy Initiatives for Contribution to Sustainability
Breakdown of Energy Consumption

Changes in Water Resources Withdrawn and Revenue
FY2016 (Base-year)

Global energy usage in FY2022 by the Astellas Group amounted to 2,048 terajoules (TJ), for a decrease of 2.0%
Water resource withdrawn (thousand m )3(41 TJ) over the previous year. The percentage of total energy consumption accounted for by electricity is highbecause in each region a large amount of electricity is consumed by the operation of air conditioningJapan

equipment.
Astellas strives to reduce its energy consumption including through the continued implementation ofUSenergy-saving measures and the introduction of highly efficient equipment.
Established Markets

Breakdown of Energy Consumption

Liquid fuelGaseous fuelHeat purchased
Electricity purchased
Renewable energy sourced
Natural energy
Wind
Wood chip biomass
Geothermal heat
Photovoltaics
Total

(TJ)
FY2019(%)

FY2020(%)

FY2021(%)

FY2022(%)

Greater China

312
1,000
26
818
102
54
6
46
2
0.6
2,210

14
45
1
37

201
992
27
812
343
54
7
45
2
0.6
2,087

10
48
1
39

201
1,001
33
807
345
47
5
41
1
0.6
2,089

10
48
2
39

194
962
28
812
335
53
6
45
0
0.6
2,048

9
47
1
40

International Markets

2

3

2

Surface water
Ground water
Others
Surface water
Ground water
Others
Surface water
Ground water
Others
Surface water
Ground water
Others
Surface water
Ground water
Others

Revenue (billions of yen)
Water resource productivity (billions ofyen/thousand m3)
Improvement from Base-year

3

FY2020

FY2021

FY2022

8,774
7,705
758
–
146
–
–
145
–
–
21
–
–
–
–
–
1,312

7,564
6,932
436
–
24
–
–
151
–
–
21
–
–
–
–
–
1,250

7,394
6,737
458
–
53
–
–
128
–
–
19
–
–
–
–
–
1,296

6,864
6,231
432
–
55
–
–
129
–
–
15
–
–
–
–
–
1,519

0.15

0.17

0.18

0.22

–

11%

17%

48%

Waste Management
Astellas is promoting efforts to reduce the waste landfill volume to as close to zero as possible through theInitiatives for Resources Recycling

proactive recycling and reuse of waste materials. Moreover, Astellas also evaluates the relationship between
the waste generation volume and economic activities with the index known as the Waste generated per unit,

Effective Use of Water Resources

and the Company is making efforts to improve it.

The effective use of water resources serves as a useful indicator for gauging society’s impact on biodiversity.

In FY2022, the waste generated per unit improved 16% over the base year (FY2016).

Astellas assesses the relationship between water resources and economic activity using a water resource
Changes in Waste Generation Volume and Revenue

productivity index, and has been striving to improve this index. Water resource productivity for FY2022

FY2016 (Base-year)

improved significantly by 48% compared with the base year of FY2016.
Waste generated (tons)
Japan
US
Established Markets
Greater China
International Markets
Revenue (billions of yen)
Waste generated per unit (tons/billions of yen)
Improvement from Base-year68

13,89911,836
54
1,956
54
–
1,312
10.6
–

FY202014,352
10,714
361
3,228
50
–
1,250
11.5
–8%

FY2021
13,882
10,158
576
3,043
105
–
1,296
10.7
–1%

FY2022
13,544
9,787
783
2,866
109
–
1,519
8.9
16%

Interview with Chief
Executive Officer

Astellas Pharma Inc. Integrated Report 2023

Corporate Strategic Plan for
Value Creation

Value Creation Story

Strengthen Foundation
for Value Creation

Corporate Data

Sustainability Strategy Initiatives for Contribution to Sustainability
Initiatives for Preventing Pollution

External Evaluation Regarding ESG

Air Pollution—Reduction of VOC* emissions

ESG Assessments

1

FY2020

FY2021

FY2022

3.6

4.0

4.3

MSCI ESG Ratings（Scale from CCC to AAA）

AA

AA

AA

CDP [Climate Change/Water Security](A to F, A is the highest)

A-/B

B/B

A-/B

Access to Medicine Index(ranks the world’s 20 pharmaceutical companies)−

14th/20

16th/20

MediumMediumLow

Astellas sets voluntary numerical targets for reducing the amount of VOCs that are emitted accompanying the useof solvents in production and research activities, and makes efforts to reduce emissions. Moreover, as a measure to

FTSE ESG Ratings（0 to 5, higher scores are better）

prevent environmental pollution by chemical substances as well as occupational illnesses, we are taking steps tominimize the impact of our business operations on our employees, local communities, and the environment, suchas development of new manufacturing processes that do not use highly hazardous chemical substances.

Air Pollution—Reduction of NOx*2 emissions
To reduce the emission of NOx into the atmosphere, Astellas has installed boilers that use gaseous fuels

Sustainalytics(Scale from Negligible to Severe)(city gas, LNG, and LPG). The NOx emissions from all business sites in Japan are as shown in the table below.
The NOx emissions from non-Japanese production sites in FY2022 amounted to 6 tons.

Inclusion in ESG Investment Indexes

Changes in Emission Volume
Substance
VOC
NOx(tons)
Target

FY2018FY2019FY2020

FY2021

FY2022

All production facilities and R&D sites in JapanAll production facilities and R&D sites in Japan

44
21

28
16

22
21

21
17

23
18

MISI Japan ESG SelectLeaders Index*1: VOC: Volatile Organic Compounds*2: NOx: Nitrogen Oxides

Water Pollution
Astellas measures the extent of its impact on aquatic environments using the BOD*3 load as an index in Japanand the COD*4 load as an index in other countries, and makes the data available to the public. In Japan, the BOD
load in FY2022 was 9 tons, the same as the previous fiscal year. Outside Japan, the COD in fiscal 2022 was 31 tons,
an increase of 7% from the previous year.
Since the discharge into water of chemical
substances used in manufacturing processes can have

Changes in BOD Load
Substance

Target(tons)FY2018 FY2019 FY2020 FY2021 FY2022

ways of reducing such discharges as much as possible

BOD
All Japanese
Drainage into rivers production
facilities andDrainage into
R&D centerssewer system

at all stages from R&D onward. With respect to future

Changes in Drainage Volume

a negative impact on ecosystems, we are examining

drug candidate substances discovered and developedby Astellas, we are examining the impact pharmaceuticals would have on ecosystems through the evaluationof their biodegradability in the natural environment.

Destination

Target

10

8

9

9

9

8

7

8

8

6

2

1

1

1

3

(thousand m3)

7,061
6,836

7,308
6,835

6,810
6,610

6,298
6,108

225

203

200

190

S&P/JPX Carbon
Efficient Index

Certified Health & Productivity Management
Outstanding Organization

Astellas awarded Compliance Leader
Verification™

Astellas supports our employees’ working styles and well-being andstrives for organizational health. Astellas’ health management promotion system in Japan is planned and operated by Human Resources,
Astellas Health Insurance Society and the labor union, and headed by
the Chief People Officer and Chief Ethics & Compliance Officer (CPO &CECO). Our efforts to promote good health have been recognizedwith certification as a 2023 Certified Health & Productivity Management Outstanding Organization by the Ministry of Economy, Tradeand Industry in Japan for two consecutive years.

Astellas has earned Compliance Leader Verification® (“CLV”) from Ethisphere, a global leader in
defining and advancing the standards of ethicalbusiness practices. Ethisphere’s Compliance
Leader Verification CLV recognizes organizations
with an outstanding commitment to achieving a
best-in-class ethics and compliance program.

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 ASPONSORSHIP, 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 USE BY Astellas Pharma Inc. OF ANY MSCI ESG RESEARCH LLC OR ITS AFFILIATES (“MSCI”) DATA, AND THE USE OF MSCI LOGOS, TRADEMARKS, SERVICE MARKS OR INDEX NAMESHEREIN, DO NOT CONSTITUTE A SPONSORSHIP, ENDORSEMENT, RECOMMENDATION, OR PROMOTION OF Astellas Pharma Inc. BY MSCI. MSCI SERVICES AND DATA ARE THE PROPERTYOF MSCI OR ITS INFORMATION PROVIDERS, AND ARE PROVIDED ‘AS-IS’ AND WITHOUT WARRANTY. MSCI NAMES AND LOGOS ARE TRADEMARKS OR SERVICE MARKS OF MSCI.

FY2018 FY2019 FY2020 FY2021 FY2022

Drainage Volume
8,058
All business
Drainage into rivers
7,820
facilities inDrainage into
Japan
238
sewer system

MSCI Japan
Empowering Women
Index (WIN)The 2-year progress report on Access to Medicine Index is as follows:
2021: https://accesstomedicinefoundation.org/resource/2021-access-to-medicine-index
2022: https://accesstomedicinefoundation.org/resource/2022-access-to-medicine-index
Copyright ©2023 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.

*3 Biochemical Oxygen Demand*4 Chemical Oxygen Demand69

Astellas Pharma Inc. Integrated Report 2023

Interview with Chief
Executive Officer

Corporate Strategic Plan for
Value Creation

Value Creation Story

Strengthen Foundation
for Value Creation

CONTENTS
Strengthen Foundation for Value Creation
Corporate Governance71

Dialogue with Outside Directors

82

Risk Management

86

Ethics & Compliance

88

70

Strengthen Foundation
for Value Creation

Corporate Data

Interview with Chief
Executive Officer

Astellas Pharma Inc. Integrated Report 2023

Corporate Strategic Plan for
Value Creation

Value Creation Story

Strengthen Foundation
for Value Creation

Corporate Data

Corporate GovernanceUpon Assuming the Post of Chairman of the Board

The Board members share a common understanding of how the oversight function of our
Board should be and are working toward improving it further.
Our Corporate Governance Guidelines clearly state that the role of the Board is to determine basic
management policies and strategies, and to serve as an oversight function for business execution. I believe it
is essential to verbalize the oversight function expected of Directors and ensure a common understanding
among all Directors in order for us to run the Board with a unified vision. In FY2022, all Directors had
discussions on how best to enhance its oversight function. As a result of these discussions, all Directors haveagreed that the oversight role of the Directors should be “to monitor and evaluate whether business execution
is carried out appropriately along with the management policies or strategies determined by the Board,”“to identify opportunities for improvement and when necessary, nudge the Company toward course correction,”and ultimately, “to decide on the appointment and remuneration of Directors and Officers entrusted withbusiness execution.” It is very important to perform these roles from the perspective of ensuring sustainablegrowth for the Company and enhancing corporate value over the medium- to long-term.
Based on the discussions above, I will lead efforts to further enhance the effectiveness of the oversightfunction of the Board of Directors by implementing specific measures, including more active and open
discussions with outside Directors.

Astellas’ Board of Directors is highly effective,
which we have achieved through diverse
board composition and through open andactive discussions.
Kenji Yasukawa
Representative Director, Chairman of the Board

I assumed the position of Chairman of the Board in June 2022 while serving as Representative Director,
President and CEO. From April 2023, I passed the baton of Representative Director, President and CEO to
Naoki Okamura, and continue to serve as Representative Director, Chairman of the Board.
Following the Annual Shareholders Meeting in June 2023, the Board of Directors has started with a newcomposition of members. With the retirement of three outside Directors, who had contributed greatly to
the Company, three new outside Directors have joined—namely, Masahiro Miyazaki, Yoichi Ohno, and
Rie Akiyama. Katsuyoshi Sugita, Astellas’ Chief People Officer and Chief Ethics & Compliance Officer (CPO &CECO) has also joined as Representative Director, Executive Vice President. As a result, the Company has
eleven Directors, including three female Directors, and continues to be diversified in terms of skills andexperience and in composition overall.
Since my appointment to the role of Chairman of the Board, I have encouraged the proactive and timely
sharing of information as well as open and active discussions. In FY2022, the Board of Directors arranged
more opportunities for advance briefings on important agenda items for outside Directors, and also had
discussion sessions on how best to enable the Board of Directors’ oversight function. The Company has also
been active in promoting dialogue with shareholders and other stakeholders, by, for example, including
outside Director interviews in the Integrated Report and having outside Directors speak at the Sustainability
Meeting 2022. I continue to be proactive in pursuing dialogue with stakeholders and would like to reflect thevarious insights gained in discussions at Board of Directors meetings.

The Board members are engaging in “growth-oriented oversight” to achieve sustainablegrowth and medium- to long-term enhancement of corporate value.
Lastly, I would like to talk a little more about “growth-oriented oversight,” raised in the above discussions of
the Board’s oversight function.
To date, the Board of Directors has been working solidly on “risk management-oriented oversight” byperiodically checking company-wide risks and how they are managed, as well as the status of complianceactivities. All Directors have agreed that we should place even greater emphasis on “growth-oriented
oversight,” and continue discussions that encourage intelligent risk-taking.
I believe that the continuous creation of innovation is essential in order to realize our VISION of being “On theforefront of healthcare change to turn innovative science into VALUE for patients,” and achieve sustainable growthand medium- to long-term enhancement of corporate value. Creating innovation, including our Focus Area
approach, is to consistently challenge the unknown and do things that have never been done before. For these boldchallenges, the Board of Directors appropriately supports the Company in making decisions in a transparent and fair
but also swift and bold manner, creating innovation through intelligent risk-taking and agile business execution.
In our new Board of FY2023, the members fully understand the role they have to play as an oversightfunction and are committed to working as one to achieve sustainable growth and medium- to long-term
enhancement of corporate value. As Chairman of the Board, I remain determined to fulfil my own role andresponsibilities to achieve our goals.

71Interview with Chief
Executive Officer

Astellas Pharma Inc. Integrated Report 2023

Corporate Strategic Plan for
Value Creation

Value Creation Story

Strengthen Foundation
for Value Creation

Corporate Data

Corporate Governance
Board of Directors (As of June 20, 2023)

Kenji Yasukawa

Naoki Okamura

Katsuyoshi Sugita

Takashi Tanaka

Eriko Sakurai

Masahiro Miyazaki

Representative Director,
Chairman of the Board

Representative Director,
President and CEO

Representative Director,
Executive Vice President

Outside Director

Outside Director

Outside Director

Rate of attendance in meetings of the Board of
Directors: 100% (14/14 times)
Number of shares of the Company owned: 127,415 shares

Rate of attendance in meetings of the Board of
Directors: 93% (13/14 times)
Number of shares of the Company owned: 33,400 shares

Number of shares of the Company owned: 1,100 shares

Rate of attendance in meetings of the Board of
Directors: 100% (14/14 times)
Number of shares of the Company owned: 0 shares

Rate of attendance in meetings of the Board of
Directors: 91% (10/11 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

April 1986:
April 2005:

April 1986:
October
2010:
April 2012:

April 1991:
Joined Asahi Kasei Corp.
January
Director, Human Resources, Medical
2005:
Devices, Johnson & Johnson K.K.
November Vice President, Human Resources, Hilti
2008:
Japan Ltd.
August 2012: Vice President, Human Resources,
AstraZeneca K.K.
July 2016:
Senior Director, Human Resources,
Microsoft Japan Co., Ltd.
May 2021:
Executive Vice President, Human Resources,
the Company (present post)
October
Senior Corporate Executive (Senmu
2022:
Tantou-Yakuin), Chief People Officer andChief Ethics & Compliance Officer (CPO &CECO), the Company
June 2023: Representative Director, Executive Vice
President, Chief People Officer and Chief
Ethics & Compliance Officer (CPO & CECO),
the Company (present post)

April 1981:

June 1987:

April 1977:

June 2010:

October
2010:
April 2011:
April 2012:
June 2012:
April 2017:

June 2017:

April 2018:
April 2023:

Joined the Company
Vice President, Project Management,
Urology, the Company
Corporate Executive of the Company andTherapeutic Area Head, Urology, Astellas
Pharma Europe B.V.
Corporate Executive of the Company andTherapeutic Area Head, Urology, Astellas
Pharma Global Development, Inc.
Corporate Executive, Vice President,
Product & Portfolio Strategy, the Company
Corporate Executive, Chief Strategy Officer(CSTO), the Company
Senior Corporate Executive, Chief Strategy
Officer (CSTO), the Company
Senior Corporate Executive, Chief Strategy
Officer and Chief Commercial Officer (CSTO& CCO), the Company
Representative Director, Executive Vice
President, Chief Strategy Officer and Chief
Commercial Officer (CSTO & CCO), theCompany
Representative Director, President andChief Executive Officer (CEO), the Company
Representative Director, Chairman of theBoard, the Company (present post)

Joined the Company
President & CEO, OSI Pharmaceuticals, Inc.

Senior Vice President, Chief Strategy Officer,
Astellas Pharma Europe Ltd.
July 2014:
Vice President, Licensing & Alliances, theCompany
April 2016:
Vice President, Corporate Planning, theCompany
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, Chief
Strategy Officer (CStO), the Company
June 2019: Representative Director, Executive Vice
President, Chief Strategy Officer (CStO), theCompany
October
Representative Director, Executive Vice
2019:
President, Chief Strategy Officer and Chief
Financial Officer (CStO & CFO), theCompany
September Representative Director, Executive Vice
2021:
President, Chief Strategy Officer, Chief
Financial Officer and Chief Business Officer(CStO & CFO, and CBO), the Company
March 2022: Representative Director, Executive Vice
President, Chief Strategy Officer and Chief
Business Officer (CStO and CBO), theCompany
April 2022:
Representative Director, Executive Vice
President and Chief Strategy Officer (CStO),
the Company
April 2023:
Representative Director, President andChief Executive Officer (CEO), the Company(present post)

Joined Kokusai Denshin Denwa Co., Ltd.
(KDD)
Executive Officer, General Manager,
Solution Product Development Division,
Solution Business Sector, KDDI
CORPORATION
June 2007: Managing Executive Officer, Executive
Director, Solution Business Sector, KDDI
CORPORATION
August 2007: 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
June 2010: Senior Managing Executive Officer, Solution
Business Sector, Consumer Business Sector,
and Product Development Sector, KDDI
CORPORATION; Chairman, UQ Communications Inc.
DecemberRepresentative Director, President, KDDI
2010:
CORPORATION
April 2018:
Representative Director, Chairman of theBoard, KDDI CORPORATION (present post)
June 2018: Director, Okinawa Cellular Telephone
Company (present post)
June 2021: Director, the Company (present post)
April 2003:*1 Figures for the rate of attendance in meetings of both the Board of Directors and the Audit & Supervisory Committee are for FY2022.
*2 The number of shares of the Company owned is as of the end of March 2023.

72

Joined Dow Corning Corporation (current
Dow Silicones Corporation)
March 2009: Chairman and CEO, Representative
Director, Dow Corning Toray Co., Ltd.
(current Dow Toray Co., Ltd.)May 2011:
Regional President Japan/Korea, Dow
Corning Corporation (current Dow
Silicones Corporation)
June 2014: Outside Director, Sony Corporation(current Sony Group Corporation)
February
President, Representative Director, Dow
2015:
Silicones Holdings Japan Kabushiki Kaisha(current Specialty Products Japan Godo
Kaisha)June 2015: Outside Director, Sumitomo Mitsui
Financial Group, Inc. (present post)
August 2020: 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
March 2022: Outside Director, Kao Corporation(present post)
June 2022: Director, the Company (present post)
June 2023: External Director, Nippon Sheet Glass Co.,
Ltd. (present post)

Joined Nissei Sangyo Co., Ltd. (current
Hitachi High-Tech Corporation)
March 1990: Chief Representative, Kuala Lumpur
Representative Office, Nissei Sangyo(Singapore) Pte. Ltd. (current Hitachi
High-Tech (Singapore) Pte. Ltd.)
January
General Manager, Electronic Components
1995:
Div., Nissei Sangyo America, Ltd. (current
Hitachi High-Tech America, Inc.)
June 2002: Deputy General Manager, Electronics Div.,
Hitachi High-Technologies Corporation(current Hitachi High-Tech Corporation)
July 2004:
General Manager, Electronics Div., Hitachi
High-Technologies Corporation (current
Hitachi High-Tech Corporation)
April 2007:
Executive Officer, General Manager,
Regional Branch Office for West Japan Area
and Kansai Branch Office, Hitachi
High-Technologies Corporation(current Hitachi High-Tech Corporation)
April 2010:
President and CEO, Hitachi HighTechnologies America, Inc. (current Hitachi
High-Tech America, Inc.)
April 2014:
Senior Vice President and Executive Officer,
General Manager, Corporate Strategy Div.,
Fine Technology Systems Business Div. andCSO (Chief Strategy Officer), Hitachi
High-Technologies Corporation (current
Hitachi High-Tech Corporation)
April 2015:
Representative Executive Officer, President
and Chief Executive Officer, Hitachi
High-Technologies Corporation (current
Hitachi High-Tech Corporation)
June 2015: Representative Executive Officer, President
and Chief Executive Officer and Director.,
Hitachi High-Technologies Corporation(current Hitachi High-Tech Corporation)
April 2021:
Chairman Emeritus, Hitachi High-Tech
Corporation
June 2022: Outside Director, Kurita Water Industries
Ltd. (present post)
June 2023: Director, the Company (present post)Interview with Chief
Executive Officer

Astellas Pharma Inc. Integrated Report 2023

Corporate Strategic Plan for
Value Creation

Value Creation Story

Strengthen Foundation
for Value Creation

Corporate Data

Corporate Governance

Yoichi Ohno

Toru Yoshimitsu

Raita Takahashi

Mika Nakayama

Rie Akiyama

Outside Director

Director,
Audit & Supervisory Committee Member

Outside Director,
Audit & Supervisory Committee Member

Outside Director,
Audit & Supervisory Committee Member

Outside Director,
Audit & Supervisory Committee Member

Number of shares of the Company owned: 0 shares

Rate of attendance in meetings of the Board of Directors:
100% (14/14 times)
Rate of attendance in meetings of the Audit & Supervisory Committee:
100% (19/19 times)
Number of shares of the Company owned: 47,818 shares

Rate of attendance in meetings of the Board of Directors:
93% (13/14 times)
Rate of attendance in meetings of the Audit & Supervisory Committee:
100% (19/19 times)
Number of shares of the Company owned: 0 shares

Rate of attendance in meetings of the Board of Directors:
100% (11/11 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

Resume, position and responsibilities at the Company

May 1993:

April 1987:
April 2013:

OctoberJoined Sanwa · Tohmatsu Aoki Audit Corporation
1986:(current Deloitte Touche Tohmatsu LLC)
August 1995: Joined Chuo Audit Corporation
May 1997:
Established TAKAHASHI Accounting & Tax office (present
post)
April 1999:
Representative Partner, ChuoAoyama
PricewaterhouseCoopers
DecemberOutside Audit & Supervisory Board Member, Alpha
2000:
Group Inc. (present post)
March 2001: Representative Director, Yoshida Management Co. Ltd.
(present post)
June 2011: Trustee, Japan Association of Healthcare Management
Consultants (present post)
January
Section President, Japanese Institute of Certified Public
2018:
Accountants, Minami-Kyushu Chapter, Kagoshima
Subcommittee
June 2020: Director (Audit & Supervisory Committee Member), theCompany (present post)

August 1984: Joined Nippon Synthetic Rubber Co., Ltd. (current JSR
Corporation)
April 2015:
Officer, General Manager of Corporate Planning
Department and General Manager of Diversity
Promotion Office, JSR Corporation
April 2017:
Executive Officer, General Manager of Intellectual
Property Department, JSR Corporation
June 2020: Director, Senior Officer, General Manager of Sustainability Promotion Dept., JSR Corporation
June 2022: Director (Audit & Supervisory Committee Member), theCompany (present post)

April 1992:
April 1999:
April 1999:

Assistant Professor, Internal Medicine, School of
Medicine, Keio University
April 1995:
Deputy Chief, Internal Medicine, Tokyo Denryoku
Hospital
April 2002:
Director, Green Town Clinic Center, and Chief, Internal
Medicine, Green Town Clinic
July 2005:
Chief, Nephrology, Endocrinology and Metabolism
Department, Internal Medicine, Saitama City Hospital
April 2007:
Senior Lecturer, Nephrology, Saitama Medical University
August 2007: Senior Lecturer, Community Health Science Center,
Saitama Medical University
April 2013:
Associate Professor, Community Health Science Centerand Nephrology, Saitama Medical University
April 2020:
Visiting Professor, Social Medicine, Research Administration Center and Medical Education Center, Saitama
Medical University (present post)
June 2023: Director, the Company (present post)

June 2015:
April 2017:
April 2019:
October
2019:
April 2020:
June 2020:

Joined the Company
Senior Vice President, Product & Portfolio Strategy, theCompany
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 andCorporate Financial Planning & Analysis, the Company
Report to CEO, the Company
Director (Audit & Supervisory Committee Member), theCompany (present post)

June 2019:
June 2023:

Joined Sanwa Bank Ltd. (current MUFG Bank, Ltd.)
Registered as attorney-at-law (Tokyo Bar Association)
Joined Baba Law Office (current Baba & Sawada Law
Office) (present post)
Outside Director, GOLDWIN INC. (present post)
Director (Audit & Supervisory Committee Member), theCompany (present post)*1 Figures for the rate of attendance in meetings of both the Board of Directors and the Audit & Supervisory Committee
are for FY2022.
*2 The number of shares of the Company owned is as of the end of March 2023.

Skills Matrix and Composition of Advisory Committees
Advisory Bodies
Nomination Committee

Compensation
Committee

Kenji Yasukawa——

Naoki Okamura——

Katsuyoshi Sugita

—

—

Chair

Chair
Member of the Committee

Name

Director

Outside Director

Company Management

Global Business

Science & Technology

Legal · Risk Management*

Finance · Accounting

Takashi Tanaka(Telecommunication)

Eriko Sakurai(Chemicals)

Member of the Committee

Masahiro Miyazaki(Precision instruments / Trading)Member of the Committee

Member of the Committee

Member of the Committee

Member of the Committee

Yoichi Ohno
Director
Audit & Supervisory
Committee Member

Academia(Medicine)

Toru Yoshimitsu
Raita Takahashi
Mika Nakayama(Accountant)(Chemicals)

Rie Akiyama(Lawyer)* The description of “Legal · Risk Management” is partially different from the previous version due to a change in the criteria for risk management skills.

73

—

—

—

—

—

—

—

—

Interview with Chief
Executive Officer

Astellas Pharma Inc. Integrated Report 2023

Corporate Strategic Plan for
Value Creation

Value Creation Story

Strengthen Foundation
for Value Creation

Corporate Data

Corporate Governance
The summary of the Company’s corporate governance systems is as follows:

Basic view

• 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 theoversight function of business execution.
• As an organ for handling business execution, the Company establishes the Executive Committee for discussing importantmatters and appoints Top Management (the President and Chief Executive Officer; the Chief Financial Officer; the Chief Scientific
Officer; the Chief Medical Officer; the Chief Manufacturing Officer; the Chief Commercial Officer; the Chief Strategy Officer; theChief People Officer and Chief Ethics & Compliance Officer; and the General Counsel are collectively referred to as “TopManagement”) to take responsibility for business execution. The responsibility and authority for the execution of business of theorgan described above and the 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.

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 tosustainably enhance enterprise value by being chosen and trusted by all stakeholders. With thisbusiness philosophy, we work to ensure and strengthen the effectiveness of corporate governance from the following perspectives:

1 Ensuring transparency, appropriateness and agility of management; and2 Fulfillment of our fiduciary duties and accountability to shareholders and appropriate(1) Board of Directors

collaboration with all stakeholders.

Ratio of females

Corporate Governance Systems (As of the end of June 2023)

Internal Directors

Outside Directors(4 males)(4 males and 3 females)

General Shareholders’ Meeting
Election / Dismissal

Election / Dismissal➀ Audit & Supervisory Committee
Audit & Supervisory
Committee OfficeElection / Dismissal

Audit andsupervision
Audit

③

① Board of Directors

Proposal / Report

Compensation Committee

Top Management

Report

The terms of office of Directors who are not Audit & Supervisory Committee Members and Directors who are Audit & Supervisory
Committee Members shall be 1 year and 2 years, respectively

Number ofmeetings

At least once every 3 months and additionally as necessary

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 ofimportant 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, iscomposed 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.
• At least one outside Director is to have management experience at other companies.

President and CEO
Direction

Internal Audit

Financial Auditor(Coordination)

Term of
OfficeAppointment / Removal, Supervision

Direction

ReportNomination Committee

CFO

CScO

CMO

CMfgO

CCO

CStO

CPO & CECO

GC

Specific matters considered by the Board of Directors in FY2022

Executive Committee
Internal
Audit

Proposal / Report

27.3%

Direction / Supervision

DivisionsExecution

74

Corporate
Strategy• Quarterly review of the progress of the corporate strategic plan • Revision of Focus Area strategy• Formulation and revision of Primary Focus strategy • Determination of FY2023 Corporate Annual Plan

Risk
Management• Review of enterprise risks and the management status thereof • Review of audit results obtained by the Audit & Supervisory
Committee and Internal Audit • Review of status of compliance activities

Stakeholder
Engagement• Approval of matters related to financial results • Review of status of dialogue with investment community• Review of results of employee engagement survey• Revision of sustainability policy • Review of status of sustainability activities

Corporate
Governance• Evaluation of Board of Directors effectiveness analysis results • Deliberations and decisions on Directors & Officers
appointment/ remuneration • Review of status of succession planning

Interview with Chief
Executive Officer

Astellas Pharma Inc. Integrated Report 2023

Corporate Strategic Plan for
Value Creation

Value Creation Story

Strengthen Foundation
for Value Creation

Corporate Data

Corporate GovernanceEvaluation of effectiveness of the Board of Directors

Eriko Sakurai

She has served in important positions for many years at a chemical manufacturer thatdevelops 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 thatcompany. She possesses abundant international experience and extensive insight. Since
June 2022, she has been playing a key role as outside Director in the management of theCompany from an independent standpoint. In addition, as a member of the Nomination
Committee and the Compensation Committee, she has contributed to the deliberations ofeach Committee by vigorously expressing opinions. The Company expects her to leverage
her abundant international experience and extensive insight for the management of theCompany from an independent standpoint in the future as well.

Masahiro
MiyazakiHe has extensive experience working overseas for an industrial trading company, and has
been engaged in corporate management for many years as a business manager of acompany that develops business globally in the field of precision instruments, etc. He
possesses abundant international experience and extensive insight. The Company expects
him to leverage his abundant international experience and extensive insight for the management of the Company from an independent standpoint.

Yoichi Ohno

He has been engaged in medical treatment for many years as a medical scientist and aclinician, and has abundant specialized knowledge and experience in medical treatment.
The Company expects him to leverage his abundant specialized knowledge and experienceto the management of the Company from an independent standpoint.

Raita
TakahashiWith many years of experience as a certified public accountant, he has thorough knowledgeof corporate consulting and auditing, and is also engaged in corporate management as abusiness 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.

Mika
Nakayama

She has abundant experience in the field of intellectual property at a globally operatingchemical 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 abundantspecialized knowledge and extensive insight to supervise and audit the Company’s management in the future as well.

Rie Akiyama

She has been engaged in corporate legal affairs as an attorney-at-law, and has abundantspecialized knowledge and experience gained through working on international cases,
serving as a civil mediator at the Tokyo District Court, etc. The Company expects her toleverage her abundant specialized knowledge and experience to supervise and audit theCompany’s management.

The Company conducts an annual analysis and evaluation of the effectiveness of the Board of
Directors as a means of examining and improving issues to further enhance the effectiveness of
OutsideDirector

the Board of Directors, and discloses a summary of the results thereof.
1 The Chairman of the Board of Directors conducted a survey based on questionnaires to Directors.

2 Based on the results of this survey, the Board of Directors performed its analysis and evaluation.

3 Evaluation of effectiveness in FY2022<Conclusion>

It was determined that the overall effectiveness of the Board of Directors is sufficiently ensured.

<Reasons for theevaluation>

As a result of the survey on effectiveness, we obtained a high evaluation as a whole, and confirmed that the following activities and discussions took place.
• The Board of Directors formulates strategy and corporate strategic plan based on the businessphilosophy, and has discussions and makes decisions while always taking into consideration
strategic direction.
• The Board of Directors effectively utilizes the Nomination Committee, and appropriately supervises succession planning and makes decisions regarding nomination.
• The Board of Directors effectively utilizes the Compensation Committee, and appropriately
establishes the remuneration system and decides the amounts of remuneration.

OutsideDirector

OutsideDirector

OutsideDirector, Audit& Supervisory
Committee
MemberInitiatives to raise the effectiveness
The Board of Directors evaluated itself as there being room for further improvement with regard to dialogue withstakeholders and oversight of sustainability activities. It will strive to further increase its effectiveness, by working tounderstand the expectations and opinions of various stakeholders and reflecting them in discussions at Board of
Directors meetings, and by deepening its involvement in and strengthening oversight of sustainability activities,
including environmental, social, and governance issues.

OutsideDirector, Audit& Supervisory
Committee
MemberReasons for appointment of outside Directors
Position

OutsideDirector

Name

TakashiTanakaReasons for appointment
He has been engaged in corporate management as a business manager of global
telecommunications 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 managementof the Company from an independent standpoint in the future as well.

OutsideDirector, Audit& Supervisory
Committee
Member75

Interview with Chief
Executive Officer

Astellas Pharma Inc. Integrated Report 2023

Corporate Strategic Plan for
Value Creation

Value Creation Story

Strengthen Foundation
for Value Creation

Corporate Data

Corporate Governance(2) Audit & Supervisory Committee(3) Nomination Committee and Compensation Committee
Nomination Committee

Ratio offemalesInternal Director

Outside Directors(1 male)(1 male and 2 females)

Ratio offemales

50%

Term of
Office

The term of office of Directors who are Audit & Supervisory Committee Members shall be 2 years

Number ofmeetings

Once a month in principle and additionally as necessary

Summary• Audit & Supervisory Board Committee assumes a part of corporate supervisory function, and contributes to the establishment ofeffective 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 opinionswith regard to audits by Audit & Supervisory Committee, and, where necessary, provides its opinions to Directors or the Board of
Directors.
• 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. At least one of the Audit & Supervisory Committee
Members is to have sufficient expertise in finance and accounting.

Specific matters considered by the Nomination Committee in FY2022• Election and dismissal of Directors*1• Selection and dismissal of Representative Directors
Election and dismissal• Selection and dismissal of Directors with executive powerof Directors, etc.
• Appointment and removal of Top Management, etc.
• Top management structure, etc.
Succession planning

Succession planning for internal Directors and Top Management*1 This includes the method of searching for and selecting new candidates for outside Directors.

Compensation Committee
Ratio offemalesSpecific matters considered by the Audit & Supervisory Committee in FY2022

25%

Outside Directors(3 males and 1 female)Specific matters considered by the Audit & Supervisory Committee include the Audit & Supervisory
Committee’s audit policy, audit plan and audit results, results of the audit of the business report and

The Compensation Committee deliberates mattersregarding remuneration, bonuses and other financial
benefits paid as consideration for the performance of
duties for Directors and Top Management, etc. (excluding
remuneration for individual Directors who are Audit &Supervisory Committee Members), and reports theresults of their deliberations to the Board of Directors.

Specific matters considered by the Compensation Committee in FY2022

financial statements, the Internal Audit division’s audit plan and audit results, development of theinternal control system and its operational status, Financial Auditor evaluation and remuneration,etc., and opinions about election, remuneration, etc., of Directors (excluding Directors who are
Audit & Supervisory Committee Members). During FY2022, the Audit & Supervisory Committee
focused on the following key audit items:• Status of HR systems, policies and measures• Status of PMI (Post Merger Integration) at the acquiredcompanies• Status of governance of subsidiaries• Status of response to challenges associated with globalization and reorganization• Accounting procedures (including tax processing) basedon management’s estimates and judgments involving
significant risks

25%

Outside Directors(3 males and 1 female)

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.

Executive remuneration level,
remuneration system, etc.,
for FY2023• Establishment of remuneration levels by position and by individual• Revision of incentive-based remuneration system (introduction of clawback clause,
adoption of a sustainability performance indicator in company-wide performance assessment for bonuses and design of assessment system, revision of performance assessment
system for Top Management, etc.)

Bonuses for FY2021

Company-wide performance assessment results and amount paid by individual

Bonuses for FY2022• Status of outsourcing• Status of risk response and risk management• Status of compliance and supervision• Status of Environmental, Social and Governance (ESG)
policies and initiatives• Status of IT-related maintenance and support

FY2019 stock compensation*

Company-wide performance targets and assessment table
2

Achievement of performance targets and number of shares delivered by individual

FY2022 stock compensation*3 Trust setup and TSR Peer Group*4 setup*2 FY2019 is the first business year of the assessment period for stock compensation, and FY2021 is the last business year of the assessment period forstock compensation.
*3 FY2022 is the first business year of the assessment period for stock compensation, and FY2024 is the last business year of the assessment period forstock compensation.
*4 See P.79 for details.

76Interview with Chief
Executive Officer

Astellas Pharma Inc. Integrated Report 2023

Corporate Strategic Plan for
Value Creation

Value Creation Story

Strengthen Foundation
for Value Creation

Corporate Data

Corporate GovernanceAmounts of remunerations

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 three whereas the number of outside Directors who are not Audit & Supervisory Committee Members was four.
*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 five.
*3 The amounts of “Basic remuneration” above include the amounts paid to two Directors (including 1 outside Director) who are not Audit & Supervisory Committee Members andone outside Director who is an Audit & Supervisory Committee Member who retired at the close of the 17th Term Annual Shareholders Meeting held on June 20, 2022.
*4 The Company has introduced a performance-linked stock compensation scheme (stock compensation), which employs a framework referred to as the executive remuneration BIP(Board Incentive Plan) trust, for the purpose of increasing the awareness of contribution to the sustainable growth of the business results and enterprise value. The Scheme is amedium- to long-term incentive-based remuneration plan that is highly transparent and objective and closely linked with the Company’s business results. Under the Scheme, withrespect to the three consecutive business years of an applicable period, the Company contributes, in the initial business year of each applicable period, funds for remuneration to
the Directors to the executive remuneration BIP trust. The ceiling amount of the contribution was resolved to be an amount not exceeding ¥1,640 million at the 14th Term Annual
Shareholders Meeting of the Company held on June 18, 2019. The maximum number of the Company’s shares acquired by Directors (including the number of the Company’s
shares to be converted into cash) was resolved to be the number obtained by dividing ¥1,640 million by the average closing price of the Company’s shares on the Tokyo Stock
Exchange in the month (March) before the initial month (April) of the first business year of every applicable period at said Annual Shareholders Meeting. At the close of such
Annual Shareholders Meeting, the number of Directors who are not Audit & Supervisory Committee Members (excluding outside Directors) was three. The stock compensation
stated above refers to the amount recorded as expenses under J-GAAP for the business year under review.

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 makethe 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 amountbasic remuneration, bonuses, and stock compensation. The Company appropriately links remunerations withbusiness performance. Remunerations for outside Directors and Directors who are Audit & Supervisory
Committee Members 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 theinternal policies concerning remunerations for Directors established by resolution of the Board of Directors after
discussions at the Compensation Committee.
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
systemA remuneration structure and levels
that enable the Company to recruitand retain talents

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)
Outside Directors who are Audit &Supervisory Committee Members
Total

Total amount of
remunerations(Millions of yen)(1)+(2)+(3)706Total amount of remunerations by type of remuneration (Millions of yen)
Total monetary
Total performanceStock
Bonus (2)remuneration
linked remunerationcompensation (3)(1)+(2)(2)+(3)Basic
remuneration (1)
229

255

222

484

477

Type of remuneration
Fixed

Basic
remuneration

Bonus(short-term
incentive
remuneration)

3

97

97

—

—

97

—

5

326

255

222

581

477

8

67

67

—

—

67

—

1

70

70

—

—

70

—

4

137

137

—

—

137

—

5

A remuneration system and composition thatare closely linked to performance with anemphasis 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 andresults regardless of country or
regionRemuneration structure/Remuneration levels*

Number ofapplicable
Directors

802

sizes increasing enterprise value andshareholder value* Where “Director” is used in this section, it refers to Directors who are not Audit & Supervisory Committee Members (excluding outside Directors).

Total amount of remunerations, total amount of remunerations by type, and number of Directors applicablefor each category of Directors (FY2022)
Category

2 Remuneration system that empha-

Variable
Stockcompensation(medium- tolong-term
incentive
remuneration)*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 theceiling 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

Objectives and overview
Fixed remuneration for encouraging job performance consistently aligned with professional responsibilities• Remuneration levels determined based on trends with respect to remuneration benchmark company groupings• Paid in equal installments every month
Performance-linked remuneration geared to steadily improving results with the aim of achieving the business performance targets each business year
• The base amount to be paid upon achieving targets is set as a proportion • Specific amount to be paid is to be determined within range of 0% toof basic remuneration, depending on factors such as professional
200% for the base amount, depending on factors such as level of
responsibilities (consideration placed on trends with respect toachieving business performance targets each business year
remuneration benchmark company groupings)• In principle, lump-sum payment immediately subsequent to conclusionof respective business years around between June and July
Performance-linked remuneration to promote the management focused on improving the enterprise value and shareholder value over the
medium- to long-term• The base amount is set as a proportion of basic remuneration, depending • The specific number of shares delivered is to be determined within a
on factors such as professional responsibilities (consideration placed on
range of 0% to 200% for the basic points, depending on factors such
trends with respect to remuneration benchmark company groupings)
as the rate of growth attained by the Company share price over a• The number of shares (basic points) to be delivered upon achieving
three-year period
targets is calculated as the base amount divided by the share price at the • In principle, delivered in a single installment around June occurring
start of the three-year applicable period (the average closing price of theimmediately after conclusion of the three-year applicable period
Company’s shares on the Tokyo Stock Exchange for the month prior to(provided, however that 50% of payment shall be cash payment)
start of the applicable period)* To ensure competitive remuneration levels for the Company’s Directors that enable the Company to recruit and retain talents, the Company will use the objective remuneration
survey data of an external expert organization (“Willis Towers Watson Executive Compensation Database (Japan)”) and other sources to select a group of companies forremuneration benchmarking, and set the remuneration levels in accordance with responsibility and other factors.

77Interview with Chief
Executive Officer

Astellas Pharma Inc. Integrated Report 2023

Strengthen Foundation
for Value Creation

Corporate Strategic Plan for
Value Creation

Value Creation Story

Corporate Data

Corporate Governance
Remuneration levels (base amount) for Directors of the Company on a per position
Base amount (Thousands of yen)basis and allocated ratios of remuneration (FY2022)

Indicator introduced from FY2023 onwardKeyperformanceindicator

500,000
200,000
40% (240,660)

400,000
300,000

40% 153,000

200,000

33% 127,500

100,000
0

166,800
33% (171,820)

27% 133,200(137,520)

27% 102,000
Representative Director,
Chairman of the board

Representative Director,
President and CEO

38% 84,376
31% 70,316
31% 70,308

Representative Director,
Executive Vice President

Sustainability
performance

Stock compensation (medium- tolong-term remuneration)
Bonus (short-term incentive
remuneration)
Basic remuneration* The figures shown in parentheses indicate
the remuneration levels (base amount)for FY2023.

Revenue

25%

Core operating
profit ratio

25%Core EPS*

25%

Variance ofassessment
coefficient

Reasons for the selection of indicators and targets

0%–200%Reasons for the selection: To assess the increase in sizeof business• Maximum: Target × 105% (¥1,515.2 billion)• Target: Initially released forecast value (¥1,443.0 billion)• Minimum: Target × 95% (¥1,370.9 billion)

0%–200%Reasons for the selection: To assess the increase inbusiness profitability and operational efficiency• Maximum: Target × 110% (22.1%)• Target: Initially released forecast value (20.1%)• Minimum: Target × 90% (18.1%)

0%–200%Reasons for the selection: To assess the increase inprofit per share• Maximum: Target × 115% (¥140.36)• Target: Initially released forecast value (¥122.05)• Minimum: Target × 85% (¥103.74)

R&D
performance25%

0%–200%

Total

100%

0%–200%Reasons for the selection: To assess the achievement ofsustainable growthTarget: Set quantitative targets separately for researchand development(1) Research: Number of new drug candidates(2) Development: Amount of increase in pipeline value

Reasons for the selection: To assess efforts toward the achievement of a sustainable society
Targets: Set sustainability performance targets for the following four evaluation items–10% to +10%(1) Initiatives for Access to Health(2) Initiatives for Talent and Organization(3) Initiatives for Stable Products Supply(4) Initiatives for Environment Sustainability

Incorporation of Sustainability Performance
The Company newly incorporated sustainability performance into its key performance indicators in FY2023.

Targets, actual results and bonus payment rate of respective key performance indicators of bonus
Assessment
weightingReasons for the selection of indicator and targets

TOPICS

Bonus (short-term incentive remuneration) (FY2022)
Key
performanceindicators

Variance ofassessment
coefficient

Actualresults

Assessment
coefficient¥1,518.6
billion200.0%

18.9%

40.0%

¥123.42“Deepen our engagementin sustainability” was set
as one of the Strategic
Goals in Corporate
Strategic Plan 2021

• Performance targets related to sustainability initiatives set for eachbusiness year
• Bonus payment rate within a range of –10% to +10% according to thelevel of achieving performance targets

Sustainability performance will be evaluated based on the following four evaluation items.

107.5%

Sustainability Compensation KPIs

Reasons for selection of evaluation items:

Initiatives for Access to Health• These items were not adequately reflected in conventional indicators for our sustainability initiatives tackling major social issues.

Initiatives for Talent and Organization• Evaluation of major initiatives related to stakeholders (especiallypatients, investors, employees, and society) will be reflected widelyin sustainability performance, which is one of the indicators forcompany-wide performance.

Initiatives for Stable Products Supply
Initiatives for Environment Sustainability—• Sustainability performance indicators added to bonuses (short-term
incentive remuneration)

83.1%

Bonus payment rate:
107.6%* EPS: Earnings per Share78

Interview with Chief
Executive Officer

Astellas Pharma Inc. Integrated Report 2023

Corporate Strategic Plan for
Value Creation

Value Creation Story

Strengthen Foundation
for Value Creation

Corporate Data

Corporate Governance
Stock compensation (medium- to long-term incentive remuneration)

Formulas for calculating the number of shares delivered and the amount of cash paid

Stock compensation (medium- to long-term incentive remuneration) is performance-linked remuneration for

Number of shares delivered
to respective Directors*

promoting management that emphasizes increase in enterprise value and shareholder value over thestock price evaluation indicator will be set to form a system that is closely linked to performance.

(i) Refer to Remuneration levels (base amount) for Directors of the Company
on a per position basis and allocated ratios of remuneration on P.78
(ii) Average closing price of the Company’s share on the Tokyo Stock
Exchange in the month prior to start of the Applicable Period

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 thegrowth rate of the Tokyo stock price index (TOPIX) for the Applicable Period and a comparison between the(b) Assessment coefficient= (i) TSR assessment coefficient (1) × 50% + (ii) TSR assessment coefficient (2) × 50%

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(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%.

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 anddividends.
*2 TSR Peer Group refers to the global pharmaceutical company 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.

Company TSR during the Applicable Period
TOPIX growth rate during the Applicable Period

FY2022 as the last business year of the assessment period for stock compensation)
Reasons for theselection ofbenchmarks

Targets

Actual results

Assessment
coefficient
200.0%TSR (1)(Comparison
with TOPIX
growth rate)

TSR (2)(Comparison
with TSR of
globalpharmaceuticalcompanies)
Total

50%

50%

100%

0% to 200%

0% to 200%

0% to 200%

To assess theincreases inenterprise value
and shareholder
value over the
medium- tolong-term

Target: Set target range asfollows• Maximum: 200%
• Target: 100%(= TOPIX growth rate)• Minimum (threshold): 50%

TOPIX growth rate:
154.3%
Growth rate of theCompany’s TSR:
127.0%

Target:
Set target range as follows• Maximum: 100 percentile
The Company’s(top ranking)ranking: 16th out of• Target: 50 percentile
31 companies(midrange)• Minimum (threshold):
25 percentile (lower quartile)={ (B – A) + C } ÷ A + 100%
(E – D) ÷ D + 100%

A: Simple average closing price of the Company’s share on the Tokyo
Stock Exchange in the month prior to start of the Applicable Period
B: Simple average closing price of the Company’s share 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 withrespect to the Applicable Period. If the Company’s percentile rank is
midrange (50 percentile), the assessment coefficient (2) is set at 100%. If it
has a top ranking (100 percentile), the assessment coefficient (2) is set to200%. 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.

Targets and actual results of respective key performance indicators, and share delivery rate (stock compensation with
Variance ofassessment
coefficient(b) Assessment coefficient(a) Basic points per position= (i) Base amount per position / (ii) Share price at start of Applicable Period

prise value and shareholder value over 3 consecutive business years (“Applicable Period”), and an appropriate

Assessment
weighting(a) Basic points per position ×* 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.

medium- to long-term. As such, the Company’s shares will be delivered based on the level of growth of enter-

Stock priceassessment
benchmarks

=

82.3%

* 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 therespective 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 aspertains 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

100.0%

Share delivery rate: 91.2%

79

TSR assessment coefficient (1)Company TSR + 100%(%)

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

(Lowestranking)

25%
ile

50%
ile

75% 100%
ile
ile(Mid-range
ranking)(Topranking)Astellas Pharma Inc. Integrated Report 2023

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Corporate Governance
Systems to Ensure the Appropriate
Execution of Business
The Company has set out basic policies regarding thefollowing systems to ensure that the Company’s business isduly executed.

(1) System concerning the Performance ofDuties1) System to Ensure the Efficient Performance of theDuties of Directors• The Company clearly separates the roles of the Directors, who participate in decision makings of corporate
management policies and corporate strategies, etc.
and oversee business execution as members of theBoard of Directors, and the roles of Top Management(the President and Chief Executive Officer; the Chief
Financial Officer; the Chief Scientific Officer; the Chief
Medical Officer; the Chief Manufacturing Officer; theChief Commercial Officer; the Chief Strategy Officer;
the Chief People Officer and Chief Ethics & Compliance
Officer and the General Counsel 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 three (3) months and additionally asnecessary.
• The Company has established the Executive
Committee and discusses material matters concerningbusiness strategies, product strategies, cooperatemanagement, and personnel of the Company and theAstellas Group companies.
• The Company has established regulations concerning
the committee mentioned above and the “Corporate
Decision Authority Policy” to clarify the powers andpositioning of the committee and the top management as well as the decision-making process.
• The Company has developed the personnel andorganization systems to enable the efficient executionof 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 performanceof duties by the Directors.

(3) Compliance System (System to Ensurethat the Performance of Duties by Directors and Employees Complies with theLaws, Regulations, and the Articles ofIncorporation)• The Company has established systems to ensure thatall documents and materials concerning importantmanagement 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.

The Company has established the “Astellas Charter ofCorporate 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 withsocial 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 thefollowing toward its implementation:• The Company has established the “Global Compliance
Committee” to understand the current situation ofcompliance and discuss policies and plans for theCompany and the Astellas Group companies as awhole. Regional Compliance Committees have also
been established to discuss compliance matters intheir respective regions.
• Under the control of the Chief People Officer and Chief
Ethics & Compliance Officer, Ethics & Compliance, incollaboration with the relevant divisions of theCompany and the Astellas Group companies, designs
and executes specific plans for global compliance. In
addition, through continuous training and othermeasures, we ensure that each officer and employeeof 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 theChief People 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.

(2) Regulations and other Systems regarding
Risk (Risk of Loss) Management
In order to conduct risk management properly as a wholegroup, the Company has categorized the risks into “risks
relating to strategic management decision-making (risks
relating to business opportunities)” and “risks relating toappropriate and efficient business conduct (risks relating
to the performance of business activities).” Each divisionand 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 throughthe following activities:• With respect to measures dealing with risks relating tobusiness opportunities, each responsible division andunit will implement appropriate measures to mitigate
risks within their respective scope of responsibility androles according to internal processes and policies for
decision making. Among these risks, mattersconcerning material risks will be decided upon deliberation by the Executive Committee and/or the Boardof 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 andResilience 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 bedecided upon deliberation by the Executive
Committee and the Board of Directors. Significant risks
identified under the system and responses to themwill be decided upon deliberation 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.

80(4) System for Disclosure and Managementof Information• The Company discloses corporate information to all of
its customers, shareholders, community and otherstakeholders in a timely, proper and fair manner. The
Company also actively engages in dialogue with themand appropriately takes into consideration commentswith respect to its business activities. Through disclosure and dialogue, the Company is committed tofurther enhancing its transparency and strive 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 thehandling of material information acquired in thecourse 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 Report• The Company will design and operate internal controls
over consolidated financial report in accordance withgenerally accepted standards in order to ensure
reliability of the financial report, and assess the effectiveness in an appropriate way.
• In accordance with the “Global JSOX Policy” formulatedby 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 owns the role of the Global Internal Control Officer.

(6) Group Management System (System toEnsure the Appropriate Execution ofBusiness by the Corporate Group
Composed of the Company and its
Subsidiaries)
The Company engages in appropriate control andoperation of the Astellas Group companies. With this inmind, the Company has taken the following actions inorder to maintain and build a sound relationshipbetween it and the Astellas Group companies:Astellas Pharma Inc. Integrated Report 2023

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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 ensurethat all persons concerned are fully aware of thesepolicies 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 mattersconcerning performance of the duties by the Directorsof the Astellas Group companies will be reported to theCompany through functional line managers.
• The Company will create clear rules regarding thecomposition of executives and decision-making
authority and internal oversight systems at the Astellas
Group companies to ensure the efficient execution ofduties by the Directors of the Group companies.
• As mentioned above, the Astellas Group will tackle risk
management and compliance matters as from anenterprise 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 directcontrol of the President and CEO, to develop theinternal audit system of the Company and the Astellas
Group companies, and takes the following actions:• The Internal Audit division will review and evaluate theeffectiveness and efficiency of the systems and structures in the various management activities of theCompany and the Astellas Group companies, put
together an audit report, and submit the results of such
review and evaluation to the President and CEO andthe Audit & Supervisory Committee. The Internal Audit
will also communicate such results, if necessary, toofficers and divisions concerned. The report concerning
the overall annual audit results will be made to theBoard 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 otherregulations as a pharmaceutical company, andconduct its business with a mission to provide safeand effective products with a high level of expertisethrough a fair organization structure. To this end, the3) 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, canaccess 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 report andmethods of reporting by mutual agreement with
Audit & Supervisory Committee.
• The divisions responsible for internal audits, legal
matters, compliance and risk management will eachdevelop a system to report to the Audit & Supervisory
Committee on a regular basis and will report theircurrent statuses and provide the necessary information with respect the Company and the Astellas Group
companies.

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, andthe internal audits conducted by the independent
Internal Audit division.
• Internal Audit division will promote improvement in
the quality of the internal audits through meetingsand other forms of collaboration with the relevant
expert divisions.
• The Head of Internal Audit division, who directly
reports to President and CEO, will manage the entire
global internal audit function, address risks effectively
by leveraging assigned personnel (Business Partnership)in line with the functional based global organizationand continuously enhance the function to provide all
the Astellas group companies with consistent highquality 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.

4) System to Ensure that Informants Do Not Risk
Unfavorable Treatments due to Their Reporting to
the Audit & Supervisory Committee• The Company prohibits any unfavorable treatment ofofficers 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.

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 theirduties, so that the audit by the Audit & Supervisory
Committee will be properly executed.

5) Matters concerning Policies to Treat Costs Incurredby the Audit & Supervisory Committee for the
Execution of Duties• The Company has established a system that the Audit &Supervisory Committee Office prepares budgets andperforms payment of costs incurred by the Audit &Supervisory Committee for the execution of their duties.

2) Matters concerning Independence of the Employees
Assisting the Audit & Supervisory Committee from the
Directors Who Are Not the Committee Members, andEffectiveness of Directions Given to Such Employees• The staff of the Audit & Supervisory Committee Office
are independent from the Directors who are not theCommittee Members and carries out his or her duties
under the direct control of the Audit & Supervisory
Committee.
• The appointment, evaluation, transfer, and othermatters concerning such staff will require the priorconsent of the Audit & Supervisory Committee.

6) Other Systems to Ensure Effective Audits by the
Audit & Supervisory Committee• The appointment, evaluation, transfer, and othermatters concerning the head of the Internal Audit
division will require the prior consent of the Audit &Supervisory Committee.

81• The Internal Audit division will obtain endorsementfrom the Audit & Supervisory Committee on theannual plan of the internal audit.
• The Audit & Supervisory Committee will receive thereport from the Internal Audit division on the results of
the internal audit, and be able to give guidance toInternal Audit division as needed. In the case where a
direction from 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 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 asimportant. In case that such Audit & Supervisory
Committee Members are not available to attend thesemeetings, the staff of the Audit & Supervisory
Committee Office may attend as observers by order ofthe Audit & Supervisory Committee.
• The persons (divisions) of the Company and theAstellas Group companies subject to be audited will
cooperate so that the Audit & Supervisory Committee
may perform the audits in an appropriate manner.

(9) System to Exclude Anti-social Forces
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 securityof 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 thepolice and other related parties, establish a solid
system that will enable the Company to actively
collect necessary information as to anti-social forcesand groups, as well as to take organizational actions.
Continually implement educational activities, such as
training on compliance and risk management, etc. forofficers and employees, so as to exclude anti-social
forces and groups.

Interview with Chief
Executive Officer

Astellas Pharma Inc. Integrated Report 2023

Corporate Strategic Plan for
Value Creation

Value Creation Story

Strengthen Foundation
for Value Creation

Corporate Data

Dialogue with Outside Directors
TakashiTanakaMika
Nakayama

Outside Director

Outside Director

The Corporate Strategic Plan 2021 (CSP2021) is a very challenging plan, in other words, a highly
ambitious plan to become a global leader in the pharmaceutical industry by continuously creating
innovation. In the first fiscal year after Astellas’ foundation through a merger in April 2005, domestic
revenue accounted for most of the consolidated total. In FY2022, though, only about 20% of total
revenue was generated in Japan. In the 15 years from 2005 to 2020, Astellas has made a rapid andsteady change in the regional composition of its revenues and is pushing for globalization.
Another notable change has been the strategic shift from a business model focusing on
specific disease areas to a Focus Area approach that explores new business opportunities from amultidimensional approach. In the process, Astellas has evolved into a company capable ofsustained transformation, through prompt decision-making, delegation of authority, and organizational change. Astellas’ corporate culture does not always remain the same, nor is it forced tochange, but rather, it anticipates change as One Astellas. Management mindset is extremely* This dialogue was conducted in May 2023.

important for this, and while Astellas has a consistent strategy, it also has ability to quickly

Astellas’ Corporate Culture and its Strengths

change course when necessary. In Astellas management I see an unwavering commitment toMika Nakayama: About a year has now passed since I assumed the role of outside Director.

high regard for the Company’s use of data to monitor progress toward individual objectives, andPrior to my appointment, I just assumed that the organizational culture within Japan’s pharma-

its creation of opportunities for direct communication between management and employees

ceutical industry would retain many vestiges of the past. When I joined Astellas, though, I realized

including Ask Me Anything sessions.

achieving its goals. As for initiatives helping employees to adapt to rapid change, I also have athat the Company is ahead of the curve, with operations that are much more global in nature

Organizational Health Goals (OHGs) from outside Directors’ perspective

than I ever imagined. Astellas does not seem to be hesitant to change, and I believe theCompany is strongly committed to carrying through the decisions it makes. I also assumed that
there would be some perception gaps between management and employees, but throughTakashi Tanaka: Even excellent strategies are meaningless if not executed. And even if they areconversations with the latter, as part of Audit & Supervisory Committee activities, I found that

executed, they are meaningless if not effective. OHGs are indicators used to ensure appropriate

management views have penetrated through to employees more than I had imagined.

conditions regarding the number of organizational layers, decision-making processes, anddelegation of authority, etc. It is essential, though, to monitor the progress of these initiatives andAstellas is strongly promoting globalization, and all employees are now moving forward
toward its goals after a period of turmoil associated with its transformation. There may be manyin some cases adjust them according to the situation. For that reason, it is important from thedifficulties, but I felt that employees are strongly motivated and optimistic about taking onoutset to be a healthy organization that can adapt flexibly to change. At Astellas, not only dochallenges and overcoming difficulties.

management have a firm grasp of these indicators, but also, the OHGs are widely disseminatedamong employees, ensuring that management and employees have both a shared under-

Takashi Tanaka: June 2023 marks two years since I assumed my role as an outside Director,

standing and common goals. I remain very impressed by this approach, as an organization

and I feel that “transformation” is at the heart of Astellas’ corporate and organizational culture.

cannot be healthy if employees are positive in front of management but dissatisfied deep down.

82Astellas Pharma Inc. Integrated Report 2023

Interview with Chief
Executive Officer

Corporate Strategic Plan for
Value Creation

Value Creation Story

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Corporate Data

Dialogue with Outside Directors
Mika Nakayama: Companies often ostensibly state the importance of strategy and organization

fiercely competitive worldwide, Astellas is setting remuneration levels and considering revisions

health, but not many actually put it into practice at all levels of the organization. More often,

to the remuneration system, referring to global benchmarks to promote change. The most recent

employees may understand the ideal but hold contrasting opinions, resulting in less than fullrevision to the remuneration system was the adoption in FY2023 of a sustainability performancecommitment to the ideal. At Astellas, though, rapid globalization has been accompanied by anindicator for determining Directors’ bonuses, a form of performance-linked remunerationinflux of diverse talent, so employees are less willing to accept inconsistency between what is(short-term incentive remuneration). Although sustainability efforts are long-term and will notthought and said. If each and every employee is committed to their duties and works on sharedyield results over a short period of time, I believe it is important to steadily build results each year

goals, it will certainly show through in the results. This inconsistency between what is said andin order for the Company to achieve its long-term goals. As sustainability initiatives progress,

what is actually meant can be common in Japanese companies, but I believe is rarely seen inpriorities may change, and I highly rate the fact that the Company sets targets and action plans

globalized organizations. By leveraging its global nature and diversity, I believe Astellas caneach fiscal year and reflects how well targets were achieved in remuneration for management.

become a very strong organization.
Takashi Tanaka: As Ms Nakayama has said, it is rare in Japan for large companies to set
organizational health goals and pursue those goals in a manner consistent with their strategy.
When there is a lack of consistency between what employees are saying and what they arethinking, the organization’s strategy will suffer. However, from my perspective as an outside
Director, I believe that in placing great emphasis on Organizational Health Goals, Astellas’management is expressing its intent to carry through its strategy and conveying a very
powerful message to its employees.

Views on succession planning and compensation system
Mika Nakayama: As for succession planning, Astellas has a list of several candidates (including
emergency replacements) for all Top Management positions including the CEO. It identifies not
only next-generation candidates but also those for the longer term, whom it closely monitors,
with a view to providing opportunities for career development. Of course, unforeseen circumstances can occur and things do not always go as planned. At Astellas, though, the Nomination
Committee submits an annual succession planning report to the Board of Directors, adjusting thecandidate list as needed.
While I am not a member of the Compensation Committee, I have been given a detailed
explanation of the remuneration system and what is discussed by the Compensation Committee.
In order to better attract the talent needed to enhance corporate value in an industry that is83

Astellas Pharma Inc. Integrated Report 2023

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Dialogue with Outside Directors
Effectiveness of Board of Directors

Takashi Tanaka: Astellas formulates strategy through highly transparent discussions including
the Nomination Committee and Compensation Committee. As a member of the Compensation
Committee, I believe it an appropriate decision that sustainability performance be added to the

Takashi Tanaka: The most important part of the deliberations, in my opinion, is the discussion

indicators for determining Directors’ remuneration, since “Deepen our engagement in sustain-

on sustainability, including the revision of the Materiality Matrix. As a pharmaceutical company,

ability” is one of the Strategic Goals set in CSP2021. As FY2023 marks the first fiscal year of using

Astellas naturally has a vision of how it should be conducting drug discovery. At the same time,

this performance indicator, in FY2024 we plan to continue discussing and reviewing this practice,though, the Company has a societal obligation to pursue sustained improvement in corporatebased on the progress and results in FY2023.

value, including via non-financial initiatives. Outside Directors also place great importance onsustainability. I heard that thorough discussions were held when including sustainability in

As can be said about the introduction of sustainability indicators, Astellas considers items on
its agenda from a long-term perspective. It has a sincere company culture in terms of steadily

CSP2021. I believe introducing sustainability indicators into Directors’ compensation was a

growing each year toward its goals, and I think this is a characteristic typical for pharmaceuticalmeaningful decision by the Board of Directors.
Monitoring is another important responsibility for outside Directors. We use a data-driven

companies, given the long-term nature of pipeline development.

approach to monitoring the progress of CSP2021, including the non-financial targets. At many
companies, the person in charge of each business reports quarterly on progress and key issues tothe Board of Directors. At Astellas, though, the CEO himself covers and reports on all companywide operations. When joining Astellas I was very surprised by the CEO’s deep grasp on the
Company’s operations.
I feel that the effectiveness of the Board of Directors has improved over the past two years. In
particular, the advance briefings to outside Directors, which it has been focusing on since FY2022
have contributed greatly. Since the Board members have most of their questions about financial
results and other important matters answered in advance, important points can be focused onwhen the Board of Directors meets.
Mika Nakayama: In my previous job, I also had the opportunity to give advance briefings to
outside Directors on Board meeting agendas. While I struggled greatly with taking sole
responsibility for briefing Directors on a wide range of issues, I believe this practice was
highly effective.
Takashi Tanaka: Without advance briefings, it takes time to gain Directors’ understanding of theissues, often leaving more items to be checked when questions are raised. However, when
Board members meet having had prior questions answered, efficacy is significantly enhanced as
one-directional explanations for the most part can be replaced with reciprocal dialog. At many84

Astellas Pharma Inc. Integrated Report 2023

Interview with Chief
Executive Officer

Corporate Strategic Plan for
Value Creation

Value Creation Story

Strengthen Foundation
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Corporate Data

Dialogue with Outside Directors
Expectations of Astellascompanies, outside Directors are not as well-informed as their internal counterparts. I think
Astellas’ efforts in this regard have been particularly effective.

Takashi Tanaka: What I am most impressed with is that Astellas lists “We excel as One Astellas”

To further facilitate information-sharing, after the Board of Directors meeting we have a forum(Outside Directors’ Meeting) for outside Directors to exchange opinions amongst themselves.

as one of its most important organizational health goals for achieving sustainable growth.

I have been able to add to my knowledge of Astellas by inquiring into other outside Directors’Some might say that technologies and development capabilities are key to adapting to bothviews and the background information. In addition, at the Outside Directors Meetings, we discussmarket changes and the modifications to organizational structures and pharmaceutical devel-

matters to further improve the Board of Directors and convey the consensus of the outside

opment processes dictated by globalization. Others might say that this rests on reviewing

Directors to the executive team.

pipelines and organizational flattening. Ultimately, though, realizing sustained growth rests on
Astellas’ organization—namely on One Astellas. I very much approve of Astellas’ choice of thisRole of outside Directors in achievement of CSP2021

wonderful goal, but at the same time one of the challenges is that the size of the Company’s
goals requires a large amount of effort from employees. However, I feel that Astellas employees

Takashi Tanaka: Unforeseen circumstances can force executive officers into correcting their

have the ability to overcome these challenges.

course. As an outside Director, it is very important to support the executive team when they are
hesitant in making a decision about a change of course, if you believe that it is necessary toMika Nakayama: Astellas has clearly defined objectives, strong management, and a sense ofachieve the corporate strategic plan since it is difficult for the executive Directors to express aunity among employees. If such attributes are overemphasized, though, it may inhibit innovative

statement that differs from what they said in the past. For Astellas to deliver sustained growth,organizational culture, free thinking, and new challenges. As Astellas continues to compete

it is essential to manage the Company in accordance with the current management framework—

globally, I believe it is important to avoid putting too many constraints on employees, and to

CSP2021. To achieve each goal in CSP2021, I will support the executive team as an outside

maintain and improve the vitality of employees, which is the foundation of the Company’s

Director, and if Astellas should stray too far from its VISION, I will have the courage to speak up

sustainability.

and express my opinion clearly.

From a diversity perspective, especially in Japan, while advancing initiatives for raising thefemale ratio to a certain level, we should not be bound by numerical objectives including theMika Nakayama: As both an outside Director and Audit & Supervisory Committee member,percentage of female managers, but should understand what “diversity” really means so that we

I engage with employees of various divisions. I will discuss both positive and negative aspects

can achieve an all-around diverse talent pool in an appropriate and compliant manner.

based on opinions from the workplace and encourage intelligent risk-taking to create innovation.
Given the high degree of compliance awareness already fostered at Astellas, it is important toTakashi Tanaka: I feel that Astellas has been able to diversify naturally when it comes to thetake a flexible approach to realize the Company’s VISION. The sincerity of the people at Astellascompany as a whole including on a global scale. The remaining issue is the employee selection

may lead to a situation in which they keep things they should be saying out loud to themselves.

process. Recruitment is prone to company-specific quirks, and unique individuals sought by

While monitoring the direction of management, as suggested by Mr. Tanaka, I would like to give

management may be dropped in the early stages of hiring. However, in the case of Astellas, it hires

appropriate support to the executive team.

worldwide and attempts to diversify at the point of hiring, so I expect Astellas to continue to attract
talent on a global basis while aiming to become a company where a diverse range of talent canplay an active role. As outside Directors, we will continue to support Astellas’ future challenges froma supervisory standpoint, while maintaining appropriate communication with the executive team.

85

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Risk Management
Business Risks(1) Risk Management Framework Relating to the Performance of Business Activities

Regulations and other Systems regarding Risk Management

Astellas’ risk management framework is as follows:

In order to conduct risk management properly as a whole group, the Company has categorized

Risk Management Framework

the risks into “risks relating to strategic management decision-making (risks relating to business

Board of Directors

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

Reports progress status

Group companies will proactively put the Company’s risk management initiatives into practiceAppoint Owner

Catastrophic Risk
OwnersExecutive Committee

and promote risk mitigation within the Group and the proper response to such risks through thefollowing activities:

Report progress status ofrisk mitigation plan

Report and approve the result of global
risk and resilience management

Global Risk and Resilience Management Committee— 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• Identify catastrophic risk and appoint owner of the risk

scope of responsibility and roles according to internal processes and policies for decision making.

• Discuss risk mitigation plan, report the plan to Executive Committee, and monitor the progress status

Among these risks, matters concerning material risks will be decided upon deliberation by the• Monitor emerging risk, status of Crisis Response Plan, Scenario Specific Playbook and Business Continuity
Plan, and on-going crisis

Executive Committee and/or the Board of Directors depending on the level of materiality
Reports results of division risk and resiliencemanagement— With respect to measures dealing with risks relating to the performance of business activities, theCompany has established “Global” and “Divisional” Risk and Resilience Management Committees toAnalysis andaggregation

Corporate Strategy

manage comprehensively 1) identification and optimal management activities of risks, and2) preparedness and status of crisis response plan and business continuity plan. Policies relating tosuch 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

Research
DRRC

deliberation 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

Technology& Manufacturing DRRC

Medical &Development DRRC

Japan
Commercial
DRRC

Greater
China
Commercial
DRRC

International
Markets
Commercial
DRRC

DRRC: Acronym for Divisional Risk and Resilience Management Committee

separate policies and manuals for matters such as disaster control, information security, and personal
information protection based on the nature of these risks.

86

UnitedStatesCommercial
DRRC

EstablishedMarkets
Commercial
DRRC

Divisional Risk Owners

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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

2 Risks related to supply chain management

regulations with a high level of compliance; Astellas must also address various risks that could

In the pharmaceuticals business, the ability to manufacture safe and effective pharmaceuticals reliably andimpact its business results and reputation. In FY2019, Astellas pursued its operation of Enterprisethen to provide their stable supply is extremely important. Astellas has identified risks related to supply
chain management as one of its critical risks. Technology & Manufacturing is leading the response to thisRisk Management with the aim of further developing the risk management activities imple-

risk, establishing its own standards compliant with industry standard Good Manufacturing Practice (GMP),

mented until now.

including manufacturing and quality controls, and Good Distribution Practice (GDP) and rigorously

Under Enterprise Risk Management, risks are identified on the Group-wide level and on theimplementing consistent high-level quality control for not only manufacturing facilities and equipment

individual division level. Those risks are classified using a uniform evaluation process according to

but also inclusive of all operations from ingredient procurement to storage, manufacturing, and delivery.

priority and, if deemed necessary, linked to an action plan. Identified risks are regularly evaluatedFurthermore, to respond to growing complexities in the supply chain, the Group has introduced ona global basis, management of its Contract Manufacturing Organizations (CMO) and is proceedingby the Global Risk and Resilience Management Committee, and solutions and mitigation

with measures including the creation of Business Continuity Plans (BCP) to ensure supply during

measures for high priority risks are discussed at the Executive Committee, chaired by the

emergency situations.

Representative Director, President and CEO.

However, despite having such measures in place, in the event that interruptions in supply, productshortage, or quality problems arise, or in the event that the reputation of Astellas is damaged as a result(3) Catastrophic Risksof the aforementioned, the Astellas Group’s business results may be significantly affected.

The risks identified by management as having the potential to have a considerable impact onfinancial position, business results and cash flow position of the consolidated companies aremainly set forth below.
In addition to the above catastrophic risks identified by the Astellas Group, there are many otherAny forward-looking statements are based on judgments at the end of FY2022.

risks. Some risks are unique to the pharmaceuticals business which include the uncertain nature ofresearch and development, the risk of being infringed upon or infringing intellectual property

1 Risks related to Cyber Security

rights, risk of drug side effects or safety issues arising thereof, and the risk of an Astellas GroupIn recent years, the technology involved in cyber attacks is advancing at an unprecedented level and themethods of attack are growing more diverse and sophisticated. In light of this environment, Astellas has

business’s partial dependence on licensing and sales of third-party developed drugs. Other risks

identified risks related to Cyber Security as one of its critical risks. The Ethics & Compliance division is

include the risk of infringement of related laws and regulations concerning competition with rival

leading the response to this risk, implementing various countermeasures against cyber attacks on a global

products, or environment or health and safety, or of commercial litigation regarding businessbasis that includes monitoring of networks and facilities, and taking every precaution to manage the risk.

processes, as well as risks of delays or stoppages in manufacturing due to natural disasters, etc., or

However, despite having such measures in place, in the event that business is substantiallyof exchange rate fluctuation. Such risks may affect the Astellas Group’s business results and financial

interrupted due to a cyber attack or serious system failure, etc., caused by a cyber attack, or in the event

position. Note that the risks stated above do not cover all of the risks relating to the Astellas Group.

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.

87

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Inspiring a Culture of Integrity
Promoting Accountability, Compliance, and Integrity

Enhancing and Sustaining an Ethical and Compliant Culture

Our dedication to serving patients is matched only by our commitment to acting withintegrity in everything we do. The Astellas Charter of Corporate Conduct expresses theCompany’s ethical business philosophy for corporate behavior. The Astellas Group Code of
Conduct (Code) establishes the expectation that everyone globally, including those working
on behalf of Astellas, perform their duties ethically and in compliance with laws and regulations.
Ethics & Compliance enables employees to make ethical and compliant decisions byproviding guidance and training. The ethical decision-making framework, called Ethics,
Value & Risk (EVR), teaches employees how to identify risks and make ethical decisions.
This promotes accountability for ethical decisions. In FY2022 Global Engagement Survey,
Integrity became Astellas’ top strength, highlighting our continued focus on creating theright culture.

Healthcare Compliance“My department has great integrity and trustworthy
people. I respect my colleagues in my department.”“I feel strongly that Astellas employees
strive to behave ethically and that
this behavior rewards itself.
Astellas rewards ethical behavior.”

Our mission is to provide safe, effective medical products that provide VALUE to patients.
Therefore, we engage ethically with Healthcare Professionals (HCPs), Healthcare Organizations (HCOs), and patient organizations, providing them with accurate information about
our products and their approved uses. The medical and scientific exchange between manufacturers and healthcare providers is essential to delivering innovative, reliable pharmaceuticals
and contributes to improving the health of patients around the world.
Astellas is committed to engaging in appropriate financial relationships with HCPs and
HCOs. We enter into consultant, fee-for-service agreements with them based on eligibility
criteria. There must be a documented and reasonable business need for their unique advice,expertise, or services, and payment is never provided as a reward or incentive for past, present,or future product use or recommendation.
Astellas adheres to all transparency
requirements across the globe, disclosing
financial relationships (transfers of value) in
accordance with local law and code. Suchdisclosures to stakeholders, legislative bodies,and the public, fulfill our obligations ofcorporate accountability.

“I feel re-inspired in my profession because the work is meaningful and mission-driven.”“Thankful for this opportunity
to deliver VALUE to patients.”

All employees are responsible for ethics and compliance and have the responsibility to
Speak Up if there is a concern of a potential or actual violation of applicable laws, codes,
Astellas policies and procedures, or other illegal or unethical behavior or business practices.
Astellas’ hotline, EthicsPoint, provides a confidential method for anyone to share theircompliance questions, concerns, or reports of alleged misconduct with us. Reports may bemade anonymously, if allowed by local laws and regulations.
Significant efforts are placed on preventing instances of non-compliance. Ethics & Compliance conducts proactive monitoring of business activities and processes, providing
opportunities for early detection and risk identification. Lessons-learned discussions,communications, training, and process improvement help employees avoid non-compliance in the future.

Anti-Bribery and Anti-Corruption (ABAC)
We are committed to operating with a high sense of integrity. Astellas strictly prohibits
bribery and corruption in any aspect of its business, including facilitation payments, andhas a zero-tolerance policy. We comply with all applicable anti-corruption laws. Our ABAC
commitment is embodied in the Code, the Astellas Group Policy on Anti-Bribery andAnti-Corruption Compliance, global policies and procedures, training, communications,risk assessments, monitoring, auditing, reporting and investigation activities. These areconsistent with the U.S. Foreign Corrupt Practices Act, the UK Bribery Act, and otherapplicable local ABAC laws and regulations.

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Inspiring a Culture of Integrity
Ensuring Fair Competition

Astellas prohibits third parties from engaging in bribery and corruption as embodied in the
Astellas Group Policy on Anti-Bribery and Anti-Corruption Compliance and the Astellas Business
Partner Code of Conduct. We conduct ABAC due diligence assessments, monitoring, and periodic
audits on third parties interacting with HCPs or government officials and include risk-based
ABAC clauses in third party contracts. We investigate potential incidents of non-compliance andaudit Astellas affiliates covering business activities that may involve heightened ABAC risks.
Astellas signed the United Nations Global Compact, including its 10th Principle Against
Corruption, and the Tokyo Principles for Strengthening Anti-Corruption Practices. Our internal
control environment complies with J-SOX regulatory requirements to ensure financial
reporting integrity, including fraud prevention and detection.

Astellas conducts its business in a fair and competitive environment. We do not makeagreements with competitors regarding sales conditions, such as prices, sales plans andstrategies, and market and customer shares. We limit our engagement with competitors
and avoid any conversation concerning these topics when engagement is necessary, sothat such interactions are not misinterpreted.
Safeguarding Privacy
Delivering VALUE for patients is at the core of everything we do. This includes safeguardingand ensuring the appropriate use of personal information we receive from individuals,
physicians, patients, employees, and suppliers. Our stakeholders trust us to keep theirinformation safe, use it transparently, and handle it with care. All Astellas employees andthird parties working on behalf of Astellas are committed to respecting and protecting
personal information.
Astellas’ Ethics & Compliance Data Privacy Office ensures that Astellas has a robust
global Privacy Program. We provide advice and guidance to ensure the appropriate collection, processing, sharing, and retention of personal information across Astellas. We have a
documented, structured Privacy Management Framework, which covers 21 basic dataprocessing activities and provides a consistent Global Privacy Strategy. The organizational
structure, privacy tools and processes allow the early identification of privacy risks globallyand their effective remediation. Astellas’ E&C Data Privacy Office ensures we adhere to allapplicable privacy laws and regulations globally and monitors compliance with them.
Astellas’ Global Data Privacy Policy, privacy processes, controls and security measuresconstitute the essential framework to protect our organization, its assets, and the personal
information we process.

Conflicts of Interest
Astellas’ Global Conflict of Interest Policy reinforces the expectation that employees act andmake business decisions that impact Astellas based on Astellas’ best interests and to avoid
potential situations or the appearance of a conflict of interest. We engage employees in thedisclosure process and associated training to enhance their ability to identify and avoid
personal conflicts and take greater ownership of compliance.
E&C Governance Structure
Chief People Officer and Chief Ethics & Compliance Officer (CPO & CECO)
Global Compliance
Committee

Global Head of Ethics & Compliance

Anti-Bribery /Anti-Corruption (ABAC)

Data Privacy

Third Party &Distributor Risk

Conflicts ofInterest

Healthcare Compliance

Compliance
Investigations

International Trade
Compliance

Global Excellence &Transformation

Global Liaison

Information Security

Regional
Compliance
Committees

Astellas awarded Compliance Leader Verification™

Heads of Strategic Business Partnering
Global Functions

Medical &Development

GlobalCommercial

Japan

EstablishedInternational

Greater China

Astellas has earned Compliance Leader Verification® (“CLV”) from
Ethisphere, a global leader in defining and advancing the standards of
ethical business practices. Ethisphere's CLV recognizes organizations
with an outstanding commitment to achieving a best-in-class ethics
and compliance program.

United States

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CONTENTS
Corporate Data
Financial Data

91

Non-financial Data

94

Major Pipeline

96Company Overview

99

90

Strengthen Foundation
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Corporate Data

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Financial Data
Income Statement(one million yen)
FY2014FY2015FY2016FY2017FY2018FY2019FY2020

FY2021

FY2022

Revenue

1,247,259

1,372,706

1,311,665

1,300,316

1,306,348

1,300,843

1,249,528

1,296,163

1,518,619

Gross profit

914,062

1,037,110

991,162

1,006,066

1,014,299

1,024,104

1,003,465

1,043,154

1,230,266

SG&A expenses

452,522500,359

470,777

478,330

490,263499,295

504,316

548,840

630,272

R&D expenses

206,594

225,665

208,129

220,781

208,682

224,226

224,489

246,010276,128Core operating profit

216,500

267,456

274,554

268,698

278,514

277,758

251,375

244,744286,902

Core profit for the year

153,244

198,802

213,343

204,326

249,343

223,178

209,906

190,584

224,619

R&D cost-to-revenue ratio (%)

16.6

16.4

15.9

17.0

16.0

17.2

18.0

19.0

18.2

Core operating profit ratio to revenue (%)

17.4

19.5

20.9

20.7

21.3

21.4

20.1

18.9

18.9

Operating profit

185,663

248,986

260,830

213,258

243,912

243,991

136,051

155,686

133,029

Profit before tax

189,683

261,770

281,769

218,113248,967

245,350

145,324

156,886

132,361

Profit for the year

135,856

193,687

218,701

164,679

222,265

195,411

120,589

124,086

98,714

14.9

18.1

19.9

16.4

18.7

18.8

10.9

12.0

8.8

IFRS core basis

IFRS full basis

Operating profit ratio to revenue (%)* 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.

91

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Financial Data
Statement of Financial Position(one million yen)
FY2014FY2015FY2016FY2017FY2018FY2019FY2020

FY2021

FY2022

1,793,578

1,799,338

1,814,072

1,858,205

1,897,648

2,315,169

2,273,628

2,332,395

2,456,518

Total non-current assets

827,621901,801

937,407

1,012,587

1,040,489

1,447,655

1,401,040

1,409,041

1,406,564

Total current assets

965,958

897,537

876,665

845,619

857,159

867,514872,588923,354

1,049,954

1,317,916

1,259,209

1,271,810

1,268,289

1,258,396

1,289,168

1,386,115

1,460,308

1,507,954

Total non-current liabilities

54,771

126,769

142,406

168,296

141,587

227,293295,141

184,676

222,530

Total current liabilities

420,890

413,359

399,856

421,620497,665

798,708592,372

687,411726,034

Ratio of equity attributable to owners of theparent to gross assets (%)

10.5

15.0

17.3

13.0

17.6

15.3

9.0

8.7

6.7

Dividend on equity (%)

5.1

5.4

5.6

5.7

5.8

5.9

5.8

6.5

7.3

Ratio of equity attributable to owners of theparent to gross assets (%)

73.5

70.0

70.1

68.3

66.3

55.7

61.0

62.6

61.4

Total assets

Total equity attributable to owners of the parent

Statement of Cash Flows(one million yen)
FY2014FY2015FY2016FY2017FY2018FY2019FY2020

FY2022

FY2021

Cash flow from operating activities

187,686

313,737

235,612

312,614258,630

221,998

306,843

257,444327,767

Cash flow from investing activities–71,476–147,050–73,383–121,799–41,757–389,793–81,894–62,413–84,500

Free cash flows

116,210

166,687

162,229

190,816

216,874–167,796

224,949

195,031

243,267

Cash flow from financing activities–121,118–193,478–166,153–203,429–233,681

181,055–229,479–216,298–195,623

Cash and cash equivalents at the end of year

396,430

360,030

340,923

331,731311,074

318,391

326,128

315,986

376,840

Key Figures per Share(yen)
FY2014FY2015FY2016FY2017FY2018FY2019FY2020

FY2022

FY2021

Basic earnings per share

61.50

89.75

103.6981.11

115.05104.15

64.93

67.08

54.24

Book value per share

600.93592.58615.89641.80667.29694.03748.03799.26839.26

30

32

34

36

38

40

42

50

60

Dividend per share* 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
Revenue by region(hundred million yen)
FY2019FY2020

FY2021

FY2022

Japan

3,454

2,791

2,588

2,623

United States
Established Markets
Greater China
International Markets
Others
Total

4,435
2,961
604
1,348
207
13,008

4,732
2,932
593
1,111
336
12,495

5,375
3,152
663
1,101
84
12,962

6,524
3,584
800
1,447
207
15,186

Sales of Main Products
Main Products
XTANDIPADCEVXOSPATA
Evrenzo
Betanis/Myrbetriq/BETMIGA
Prograf(hundred million yen)(hundred million yen)
FY2019FY2020

FY2021

FY2022

4,000
18
143
2
1,616
1,929

4,584
128
238
11
1,636
1,827

5,343
217
341
26
1,723
1,854

6,611
444
466
32
1,886
1,988

XTANDIJapan
United States
Established Markets
Greater China
International Markets
Total

358
2,035
1,354
32
221
4,000

402
2,386
1,493
49
255
4,584

472
2,769
1,701
79
322
5,343

547
3,418
1,979
111
556
6,611

PADCEVJapan
United States
Established Markets
International Markets
Total

—
18
—
—
18

—
128
—
—
128

18
195
5
—
217

84
292
68
1
444

FY2019FY2020

FY2021

FY2022

XOSPATAJapan
United States
Established Markets
Greater China
International Markets
Total

28
105
9
—
—
143

38
155
44
0
2
238

39
189
90
15
7
341

43
255
121
25
22
466

EvrenzoJapan
Established Markets
International Markets
Total

2
—
—
2

11
—
—
11

25
1
—
26

24
6
2
32

Betanis/Myrbetriq/BETMIGA
Japan
United States
Established Markets
Greater China
International Markets
Total

343
892
282
14
84
1,616

351
880
299
22
85
1,636

375
872
367
29
81
1,723

335
965
428
39
118
1,886

PrografJapan
United States
Established Markets
Greater China
International Markets
Total

443
132
715
322
317
1,929

407
118
642
342
317
1,827

382
94
679
381
317
1,854

356
107
693
468
363
1,988

*1 Sales of products in Japan are shown on a gross sales basis.
*2 Established Markets: Europe, Canada*3 Greater China: China, Hong Kong, Taiwan*4 International Markets: Russia, Latin America, Middle East, Africa, Southeast Asia, South Asia, Korea, Australia, Export sales, etc.
*5 From FY2022, the commercial segment of Australia was changed from Established Markets to International Markets..
For the purposes of this chart, FY2022 data reflect this change.

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Non-financial Data
Environment

Number of Employees per Region and Turnover Rate

GHG Emissions Volume*1 (Scope 1, Scope 2) (Tons)
Scope 1
Scope 2
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)
VOC
NOx
Changes in Drainage Volume*5 (1,000 m3)

FY2020

FY2021

FY2022

123,320
63,27660,044
2,087
7,564
14,352

118,679
63,691
54,9882,089
7,394
13,882

117,644
61,171
56,473
2,048
6,864
13,544Japan(Astellas Pharma Inc. ·Group companies)
Other Areas Total
Established Markets
Greater China

22
21
7,308

21
17
6,810

23
18
6,298

International Markets*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 Target (VOC, NOx): all production facilities and R&D sites in Japan.
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.

United States
Total

Japan
(Astellas Pharma Inc. ·Group companies)
Other Areas Total

Average

5,659

4,948

4,867

Turnover rate

2.6%

*2 18.1%

4.4%

Number of employees

9,796

9,574

9,617

Turnover rate

15.3%

15.7%

14.5%

Number of employees

3,608

3,454

3,365

Turnover rate

10.9%

14.1%

13.9%

Number of employees
Turnover rate

Male
FemaleRatio of female managers
Male
FemaleRatio of female managers
Male
FemaleRatio of female managers

70.8%
29.2%
15.1%
44.1%
55.8%
52.6%
53.9%
46.1%
39.7%

69.1%
30.9%
17.2%
44.8%
55.2%
53.5%
53.1%
46.9%
43.0%

1,325

1,183

1,129

*2 41.1%*2 30.2%

14.3%

Number of employees

1,524

1,445

1,493

Turnover rate

12.9%

22.7%

15.8%

Number of employees

3,339

3,492

3,630

Turnover rate

10.9%

9.3%

14.5%

Number of employees

15,455

14,522

14,484

Turnover rate

10.6%

16.5%

11.1%

(As of March 31, 2023, Japan consolidated basis.)

FY2021

FY2022

Number of employees*1

Average Length of Service (Years) By Gender

FY2020

FY2021*1 The turnover rate in Japan excludes people retiring at the mandatory retirement age and employees moving outside of the Group due to transfer
of Group businesses.
*2 Implemented early retirement incentive system.

SocialEmployee Ratio per Region and Ratio of Female Managers

FY2020Male
FemaleFY2022
68.8%
31.2%
17.6%
44.8%
55.2%
54.0%
52.9%
47.1%
42.8%

Employment (Japan)
Total
Male
FemaleTotal
Mid-career hires(Astellas Pharma Inc. ·MaleGroup companies)
FemaleAstellas pharma Inc.
Mid-career hire ratio of
new hiresGroup companies in Japan
Ratio of female employees in new hires*(Astellas Pharma Inc.)
Ratio of people with disabilities employed

New graduate hires(Astellas Pharma Inc. ·Group companies)* 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.

* Japan consolidated basis

94

FY202018.4
13.4

FY2020

FY2021
17.4
13.0

FY2021

FY202217.3
13.6

FY2022

66
41
25
78
51
27
50.4%
100%

71
38
33
96
71
25
57.3%
58.8%

87
53
34
105
66
39
54.7%
—

36.1%

34.7%

38.0%

2.37%

2.49%

2.78%

Interview with Chief
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Astellas Pharma Inc. Integrated Report 2023

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Corporate Data

Non-financial Data
Highly Skilled Employees with Specialized Knowledge and Skills
PhDs (globally)*
Employees engaged in R&D (Research and Development) in cell therapy,
gene therapy, and regenerative medicine

FY2020

FY2021

FY2022

Occupational Health & Safety (Global)

2020.1–12

2021.1–12

2022.1–12

—

—

1,281

Number of work-related injuries (leave of absence)
Frequency rate of work-related injuries

6
0.18

10
0.33

17
0.57

—

—

933

Severity rate of work-related injuries

0.005

0.008

0.016

FY2020

FY2021

FY2022

11
7
64%
2
18%
15
100%
4
3
1
15

11
7
64%
1
9%
13
99%
4
3
1
14

10
7
70%
3
30%
14
98%
4
3
2
19

* As of March 31, 2023. Based on data self-reported by employees; includes directors.

Data Related to Life Events (Japan)

FY2020

FY2021

FY2022Governance*

95
96
101
Female: 105%
Female: 101%
Female: 97%
Average days used: 396 Average days used: 399 Average days used: 402
Child Care Leave acquisition rate*3
Male: 74%
Male: 76%
Male: 96%
Average days used: 29 Average days used: 91 Average days used: 62
Time off for Infant Care
14
14
10
176
206
387
Shortened Work Hours for Childcare
Average days used:
Average days used:
Average days used:
1,037
1,185
1,224
Male: 17
Male: 22
Male: 17
Use of the Company’s Vehicles forChild Raising
Female: 39
Female: 57
Female: 52
Financial Assistance for Daycare
3
10
Paid Leave for Employees Returning
to Work After Leave of Absence
24
24
14
Before and After Childbirth/
Leave for Child Care
Nursing Care Holiday
20
22
18
Leave for Nursing Care——2
Shortened Work Hours for
1
3
4
Nursing Care
Registered Employees
Registered Employees Registered Employees
Working at Homefor the Program: 5,214 for the Program: 6,014 for the Program: 4,281
Paternity Leave

Child-raising

Nursing careChild care, nursing
care, injury, other

Board of Directors (Persons)
Of which Outside Directors (Persons)Board of Directors structure
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 Members (Persons)Audit & Supervisory
Of which Outside Directors (Persons)Committee structure
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
Chair
Nomination Committee
structureMember 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*1 Japan consolidated basis*2 The number of users indicates those who used the system in each fiscal year. 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.
*3 The Child Care Leave acquisition rate of male employees includes Astellas’ original child care leave system.

Employee Engagement
Engagement score

FY2020Member 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 theCompensation Committee

FY2022

FY2021—

Chair
Compensation Committee
structure—71** A new engagement survey platform was introduced in FY2022 which is better suited for timely identification of actions and responses related to
the CSP2021 and Organizational Health Goals. Due to this change, only FY2022 scores are disclosed as they cannot be directly compared to past
survey results.

* The numbers of the Board of Directors are as of the end of each fiscal year.

95

100%

100%

100%

OutsideDirector

OutsideDirector

OutsideDirector

5

5

4

4
7

4
7

4
7

100%

96%

100%

OutsideDirector

OutsideDirector

OutsideDirector

5

5

4

4
7

4
8

4
7

100%

100%

100%

Interview with Chief
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Astellas Pharma Inc. Integrated Report 2023

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Value Creation Story

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Corporate Data

Major Pipeline(as of July 2023)

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
Generic name
Code No.
(Brand name)

Modality / Technology

Classification

Target disease

Metastatic castration-sensitive prostate cancer
enzalutamide
MDV3100 (XTANDI)

Small molecule

Androgen receptor inhibitor

Phase*1
1

2

3

Licensor*2

F

China
US (June 2023)

PfizerNon-metastatic castration-sensitive prostate cancer
EuropeMetastatic urothelial cancer, platinum-containing chemotherapy and PD-1/
L1 inhibitor pretreated

China(Mar 2023)

Metastatic urothelial cancer, previously untreated (first line; combo with pembrolizumab)
enfortumab vedotin
ASG-22ME (PADCEV)

Antibody-drug conjugate(ADC)

Nectin-4 targeted ADC

In-house[Co-development with Seagen]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

gilteritinib
ASP2215 (XOSPATA)

Small molecule

FLT3 inhibitor

Newly diagnosed acute myeloid leukemia with high intensity induction of chemotherapy

In-house

Newly diagnosed acute myeloid leukemia with low intensity induction of chemotherapy
Acute myeloid leukemia in pediatric patientszolbetuximab
IMAB362

Antibody

Anti-Claudin 18.2
monoclonal antibody

Gastric and gastroesophageal junction adenocarcinoma

Japan (Jun 2023)
US (Jul 2023)
Europe (Jul 2023)
China (Jul 2023)

In-house(Ganymed)

Pancreatic adenocarcinoma
Europe (Sep 2022)
fezolinetant
ESN364(VEOZAH)

Small moleculeNK3 receptor antagonist

Vasomotor symptoms due to menopause

China
Japan

*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.

96

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Major Pipeline
Generic name
Code No.
(Brand name)

Modality / Technology

Classification

Phase*1

Target disease

1

2

3

US (Feb 2023)
Europe (Jul 2023)

Geographic atrophy secondary to age-related macular degeneration
avacincaptad pegol

Pegylated RNA aptamer

Licensor*2

F

Complement C5 inhibitor

In-house(Iveric Bio)

Stargardt diseaseresamirigene bilparvovec
AT132

Gene therapy(AAV-based gene therapy)

MTM1 gene replacement toexpress myotubularin

In-house(Audentes Therapeutics(currently Astellas Gene Therapies))

X-linked myotubular myopathy*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.

Projects with Focus Area approach
Generic name
Code No.

Primary Focus

Modality / Technology

Classification

Target disease2

3

Licensor*2

F

ASP1570

Small molecule

DGKζ inhibitor

CancerIn-house

ASP2138

Antibody

Anti-Claudin 18.2 and anti-CD3
bispecific antibody

Gastric and gastroesophageal junction adenocarcinoma,
pancreatic adenocarcinoma

Xencor[Discovered through collaborative research]

ASP2074

Antibody

Bispecific antibody

CancerIn-house

ASP1002

Antibody

Bispecific antibody

CancerIn-house

Geographic atrophy secondary to age-related maculardegeneration

In-house(Ocata Therapeutics(currently Astellas Institute for Regenerative
Medicine))

Immuno-Oncology

Blindness andRegeneration

ASP7317

Cell therapy

Retinal pigment epithelium cells

Mitochondria

bocidelpar
ASP0367/MA-0211

Small molecule

PPARδ modulator

resamirigene bilparvovec
AT132*3

Gene therapy(AAV-based gene therapy)

MTM1 gene replacement to express
myotubularin

X-linked myotubular myopathy

AT845

Gene therapy(AAV-based gene therapy)

GAA gene replacement to express
GAA enzyme

Pompe disease

ASP3082

Small molecule

KRAS G12D degraderCancerPrimary mitochondrial myopathies
Duchenne muscular dystrophy

Genetic regulation

Targeted Protein
Degradation

Phase*11In-house(Mitobridge)
In-house(Audentes Therapeutics(currently Astellas Gene Therapies))
In-house(Audentes Therapeutics(currently Astellas Gene Therapies))
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”.

97Interview with Chief
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Corporate Data

Major Pipeline
OthersGeneric name
Code No.

Modality / Technology

Classification

Target disease

Phase*1
1

2

3

Licensor*2

F

Neurogenic detrusor overactivity inpediatric patients

EuropeOveractive bladder in pediatric patients

Europe

JAK inhibitor

Rheumatoid arthritis

China (Aug 2022)

In-house

Small molecule

Azole antifungal

Invasive aspergillosis and mucormycosis
in pediatric patients

US (Jun 2023)

Basilea

Small molecule

GABAB receptor positive allosteric modulator

Alcohol use disordermirabegron
YM178

Small molecule

peficitinib
ASP015K

Small molecule

isavuconazole
ASP8062

β₃ receptor agonist

In-house

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+ Programs
Category(Business area)

Digital health
Other services

Drug-device combination

ProgramConcept

Status*Partner

Fit-eNce

Service to provide scientifically evidenced exercise programs andsystems supporting regular exercise

Under feasibility study

Fit-eNce Home

Service to provide scientifically evidenced exercise programs andsystems supporting regular exercise at home

Under feasibility study

BlueStar

Digital therapeutics for adults with diabetes

Under clinical trial preparation

Welldoc
Roche Diabetes Care Japan

Intraoperative ureter visualization for use in patients undergoing minimally invasive andopen abdominopelvic surgeries

P-III

Stryker

Visualization and localization of lymph nodes in patients with breast cancer ormelanoma undergoing lymphatic mapping

P-II

pudexacianinium chloride
ASP5354* The list shows the most advanced stage if the stages are different depending on the region.

98

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Astellas Pharma Inc. Integrated Report 2023

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Value Creation

Value Creation Story

Strengthen Foundation
for Value Creation

Corporate Data

Company Overview(As of March 31, 2023)

Company Information

Share Price and Volume

Company Name

Astellas Pharma Inc.

Stock Price(Yen, Point)

Trading Volumes(Thousands of shares)

Headquarters

2-5-1, Nihonbashi-Honcho, Chuo-Ku, Tokyo 103-8411, Japan

2,500

250,000

Foundation

1923

Capital103,001 million yen

2,000

200,000

1,500

150,000

1,000

100,000

500

50,000

Representative Director Naoki Okamura (President and Chief Executive Officer)*
Employees

5,123 (Unconsolidated)* Appointed as President and Chief
Executive Officer effective April 1, 2023.

14,484 (Consolidated)

Stock Information
Status of Shares
Securities Code4503

Listed Stock Exchange

Prime Market

Fiscal Year-end

March 31

Custodian of Sumitomo Mitsui Trust Bank, Limited
Register of
1-4-1, Marunouchi, Chiyoda-ku, Tokyo
Shareholders 100-8233, Japan
Accounting
Auditor

General Meeting of
Shareholders

June

Minimum Trading Unit

100 shares

Total Number ofAuthorized Shares

9,000,000,000 shares

0

Ernst & Young ShinNihon LLC.

Astellas (Left scale)

38.3

4.6

FY2022(140,246)

0■ Securities Companies

3.1

38.4

5.0

2016/3

TOPIX (Left scale)2017/3

2018/3

2019/32020/32021/32022/32023/30■ Volume (Right scale)

3.2

39.6

Number of shares held(Thousands of shares)

Shareholding
percentage (%)

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

408,021

22.55

Custody Bank of Japan, Ltd. (trust account)

156,046

8.62

Nippon Life Insurance Company

51,5882.85

State Street Bank West Client - Treaty 505234

34,286

1.89

JPMorgan Chase Bank 385781

24,793

1.37

SSBTC Client Omnibus Account22,8101.26

State Street Bank and Trust Company 505103

22,137

1.22

JPMorgan Securities Japan Co., Ltd.

19,213

1.06

Goldman, Sachs & Co. Reg

17,2900.95

State Street Bank and Trust Company 505001

16,5700.91

Name of shareholders

Trends in Shareholder-Type Ratio

FY2021(86,322)2015/3Major Shareholders (Top 10)

Number of Shareholders 140,246

4.3

2014/3* The Company conducted a stock split of common stock at a ratio of five-for-one with an effective date of April 1, 2014.

Number of Shares
1,809,663,075 shares
Issued and Outstanding (Including 12,900,609 shares oftreasury stock)

FY2020(93,953)

2013/3

8.6

45.6

8.2

3.1

45.5

8.9

43.3

20

40

60

80

■ Financial institutions■ Other companies■ Individuals, other■ Foreign entities, etc.

0.1

0.0

0.0

* Number of shares held are presented by discarding the numbers down to the thousand, and percentage of shares are presented by discarding thenumbers down to the third decimal (1,834,939,741 shares).

100 (%)■ Treasury stock99

Interview with Chief
Executive Officer

Astellas Pharma Inc. Integrated Report 2023

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Value Creation

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for Value Creation

Corporate Data

Company Overview
Subsidiaries & Locations (as of May 2023)

As a global pharmaceutical company, we are currently working in about

Established Markets*1

Iota Biosciences, Inc.
Astellas Gene Therapies
Astellas VentureManagement LLC(San Francisco office)Astellas Rx+ BusinessAccelerator, LLC

Astellas Ireland Co., Ltd.
Dublin Plant
Astellas Ireland Co., Ltd.
Kerry Plant

Astellas Pharma
Europe B.V.
Meppel Plant

Astellas Pharma
Global Development, Inc.

Universal Cells, Inc.

United States

70 countries

Mitobridge, Inc.
Business Development(Boston office)Astellas Institute forRegenerative Medicine (AIRM)

Business Development(Cambridge UK office)Nanna Therapeutics Limited(United Kingdom)

Astellas Gene Therapies(Sanford)

International Markets*3
Astellas Pharma China, Inc.
Shenyang Plant

Japan

Takahagi Technology Center
2

Greater China*
Astellas (China)
Investment
Co., Ltd.

Takahagi Chemistry &Technology Development
CenterYaizu Technology
Center
Yaizu
Pharmaceutical
Research Center

Business Development(San Francisco office)Toyama Technology Center
Takaoka Plant

Tsukuba Research Center
Tsukuba Biotechnology
Research Center
Headquarters (Tokyo)
Business Development

Xyphos Biosciences, Inc.

Headquarters
R&D bases
Manufacturing BasesBusiness development bases*1 Established markets: Europe, Canada*2 Greater China: China, Hong Kong, Taiwan*3 International Markets: Russia, Latin America, Middle East, Africa, Southeast Asia, South Asia, Korea, Australia, etc.

100