Integrated Report 2023
For the year ended December 31, 2023

Life-changing

Kyowa Kirin Co., Ltd.

Kyowa Kirin Co., Ltd.
Integrated Report 2023

CONTENTSINTRODUCTION

AT A GLANCETOPICS FORVALUE CREATIONTOPICS FORVALUE ENHANCEMENTFINANCIAL INFORMATIONCORPORATE INFORMATION

01

CONTENTS
02 INTRODUCTION

21 TOPICS FOR VALUE CREATION

37 TOPICS FOR VALUE ENHANCEMENT

02
06
08
09
10

21
25
27
28

37 Quality Assurance
38 Stable Supply
39 Ensure a Thriving Global Environment for
Future Generations
42 Human Rights
43 Governance48 Implementation Status of Dialogue with
Shareholders, etc.
49 Compliance
50 Risk Management
51 Management
52 Directors’ Profiles
53 Audit & Supervisory Board Members’
Profiles/Executive Officers

11
12
13
14

Message from the CEO
History of Value Creation
Our Philosophy and Core ValueOur Vision toward 2030
Strategies and Challenges for Achieving
Our Vision
Value Creation Story
Materiality
Co-creating Value with Stakeholders
Financial Strategy

R&D Strategy
Strategic Partnering
Initiatives to Improve Access to Medicines
Global Strategic Products / Next-generation
Drugs in the Development Pipeline
29 Special Discussion—Human Capital Reinforcement toward
Sustainable Growth—

32 Kyowa Kirin’s Growth Globally
35 Digital Transformation Strategy

16 AT A GLANCE
16
17
18
19

Headline News
Financial Highlights
ESG Highlights
Pipeline

54 FINANCIAL INFORMATION
55 Eleven-Year Selected Financial Data
56 Management’s Discussion & Analysis (MD&A)
61 Risk Factors

64 CORPORATE INFORMATION
64 Corporate Data
65 Investor Information

Materiality

Scope of This Report
Kyowa Kirin Co., Ltd. and its consolidated subsidiaries

High
Impact of sustainability on society

Annual Report (PDF version)
https://ir.kyowakirin.com/en/library/annual.html* Indication is provided in cases where the scope of reporting differs.

Reporting Period
January to December 2023

Reported in
the book

Corporate website

https://www.kyowakirin.com/index.html* The latest information at the time of publication is also included where possible.

Investors (IR)https://ir.kyowakirin.com/en/index.html

Disclaimer• Financial Results
https://ir.kyowakirin.com/en/library/earnings.htm• Corporate
Governance Report https://ir.kyowakirin.com/en/management/governance.html
Sustainability (CSR) https://www.kyowakirin.com/sustainability/index.html• ESG Data
Impact on the Group’s businesses

Highhttps://www.kyowakirin.com/sustainability/esg_data/index.html

Statements concerning future plans and forecasts are based on information
currently available to the Company and certain assumptions that theCompany believes to be reasonable. Actual results and performance may
differ due to various risks and uncertainties. Statements concerning ethicalpharmaceuticals and products under development are not intended asadvertising, promotions, or medical advice.

For inquiries about the Integrated Report:
IR&PR Group, Corporate Communications Department, Kyowa Kirin Co., Ltd.
+81-3-5205-7206/https://faq.kirin.co.jp/form/kkc_04.html

Motohiko Kawaguchi
Managing Executive Officer,
Chief Financial Officer (CFO),
Kyowa Kirin Co., Ltd. (In charge ofFinance, Corporate Communications
and Procurement Departments)

About the publication of theIntegrated Report
Kyowa Kirin’s Integrated Report is published for our shareholders, investors, and a wide range of other stakeholders.
It introduces our business—both in its financial and non-­financial aspects—as we “strive to contribute to the healthand well-being of people around the world by creating newvalue through the pursuit of advances in life sciences andtechnologies.” In producing this report, we referred to theInternational Integrated Reporting Framework proposedby the International Financial Reporting Standards (IFRS)Foundation and the Guidance for Collaborative Value
Creation 2.0 issued by Japan’s Ministry of Economy, Tradeand industry (METI).
Production of this report was led by the Corporate­Communications Department, in collaboration with the
Corporate Planning and other departments across theorganization. As head of the Corporate Communications
Department, I have confirmed that the content of thisreport is accurate.
We hope that this report may be of use as a tool forcommunication with our stakeholders, leading to thecreation of new shared value.

Kyowa Kirin Co., Ltd.
Integrated Report 2023

CONTENTSINTRODUCTION

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02

Message from the CEO“Strive to become a superb team. One human being, excellent or not, is everso powerless, as a power of one, mistakes even a possibility. Show the world
the excellence of coming together. Amazing results, when we become one.”
This is an excerpt from our Mission Statement, the result of discussions between employees and management before the merger that createdMasashi Miyamoto,Ph.D.

Kyowa Kirin in October 2008. This part of the statement in particular resonates with me. Our Vision for 2030 is to “consistently create and deliver

Representative Director of
the Board, President andChief Executive Officer (CEO)team of experts with a shared passion for innovation.” Since its inception, Kyowa Kirin has delivered some outstanding outcomes, which could

life-changing value that ultimately makes people smile, as a Japan-based Global Specialty Pharmaceutical (GSP) company backed by a diverse
only have been achieved by drawing on the strengths of every single employee and being fully committed to our mission. But there are still
diseases worldwide that lack effective treatments, causing suffering and distress to many people. Our goal is to continue bringing a smile tothe face of as many patients as possible with our medicines. This will mean cultivating diverse human resources with a strong sense ofcommitment to solving these challenges and forming teams that share this vision. This is the kind of company we want to be.

FY2023 results review
In FY2023, the midpoint of our FY2021–2025 Medium Term Businessclinical trial for the treatment of moderate to severe atopic dermatitis.

Plan, we continued to make steady progress towards our 2030 Vision. In

The trial is making steady progress, with over 2,400 patients enrolled as

North America, we started sales of Crysvita through proprietary chan-of February 2024.

nels, and in EMEA we established a new business structure that allows us

Earnings in FY2023 were also strong. We reported revenue of ¥442.2

to focus on Crysvita and Poteligeo. In R&D, we made good progress withbillion, core operating profit of ¥96.8 billion and profit attributable to

the global development of KHK4083 and KHK4951 and we began clinicalowners of parent of ¥81.2 billion, a new record. On a single fiscal year

trials of proprietary bispecific antibody drugs. KHK4083, which is being

basis, we also achieved the main KPI in our medium term businessdeveloped with Amgen Inc. and has been positioned as the next growthplan — ROE of 10% or higher. These results underscore the progress wedriver after Crysvita, is currently in Phase 3 of the ROCKET program, aare making towards transforming Kyowa Kirin into a Japan-based GSP.

Kyowa Kirin Co., Ltd.
Integrated Report 2023

CONTENTSINTRODUCTION

Changes in the business environment since the medium-­term plan was formulated
The environment surrounding our business and our industry has beenchanging rapidly in recent years. This is testing our ability to create
life-changing value and deliver growth while also responding quickly
and accurately to change.
In response, we have set up a proprietary global sales structure for
Crysvita, Poteligeo and other products, creating a framework for growthin the Group’s key treatment areas – skeletal and mineral disorders,
blood cancer and intractable blood disorders, and rare diseases. Also,with our acquisition of Orchard Therapeutics plc, we have gained atherapeutic platform in hematopoietic stem cell gene therapy (HSC-GT),
which has the potential to cure some genetic diseases. This will allow us
to deliver new value in the rare disease field worldwide.
We have also established a new business model to maximize thevalue of development drugs through co-development with partners,
similar to the approach we took with Fasenra and KHK4083.
However, our operating environment is undergoing major changes,
including: a global trend toward stricter healthcare policies and regulations to reduce medical costs; growing needs for the practical applica-

AT A GLANCETOPICS FORVALUE CREATIONTOPICS FORVALUE ENHANCEMENTFINANCIAL INFORMATIONCORPORATE INFORMATION

Qualitative Review for FY2023
Provide pharmaceuticals for unmet medical needs

Address patient-centric healthcare needs

Maximize the value of global strategic productsPatient Advocacy

Initiated own sales of Crysvita in North America and keep steady growth
Focused on Crysvita and Poteligeo and accelerated the growth under the new EMEA structure
Further penetration of Crysvita

Raised disease awareness of XLH and created and expanded opportunities for patientinteractions
Conducted disease awareness campaign with centering World Lymphoma Day and initiatives
with patient organizations.
Expanded disease awareness activities centered on Rare Disease Month
Hosted an event at “Healthcare Café” organized by four JP pharmaceutical companies (Japan)

Continue to create groundbreaking new drugs
Accelerated Global Development of rocatinlimab (over 2,400 patients has registered) andmoved forward P2 clinical trial preparation for KHK4951
Started P1 study of KK2260, an antibody with REGULGENT™ (our proprietary bispecific antibody
technology)
Received an approval for manufacturing and marketing PHOZEVEL®
Discontinued the development of RTA 402 and KW-3357PE
Had a definitive agreement to acquire Orchard Therapeutics

Reinforce human resources and structures that support thecreation of life-changing value
Cultivate human resources, Strengthen organizations,
Build digital platforms, and Others
Human resources and organization development and: Proceeded succession planning for
global key positions. Renewed talent management practices for the managers in Japan,
Continued the effort to embed Corporate Culture Transformation “KABEGOE”
DE&I: Reached the ratio of women in key positions under OKK structure to 30%, Rated “Gold” inthe PRIDE Index 2023 (JP)
Selected as a 2023 “Health & Productivity Stock” for consecutive two years (JP).
Digital infrastructure improvement: Developed Dx human resource, Launched company-wide
use of generated AI in-house environment, Improved efficiency and IT literacy with no-codeand low-code tools (RPA, etc.)
Strengthened the leadership structure with expanding CxO structure

Provide value that goes beyond pharmaceuticals
Had an initiative to address patient needs related to XLH/TIO with Ubie.
Planned to address patient needs related to XLHRetain the trust of society
Ensure stable supplies of high-quality pharmaceuticals
Proceeded to establish the key products supply system with multiple production sites
Full operation of Takasaki Q-TOWER (quality assurance-related complex)
Addressed human rights issues for all stakeholders through membership in JaCER*1

Help to protect the global environment
Reduced CO2 emissions by 55% compared to 2019 with using renewable energy
Disclosed necessary information responding to Assembly Bill No. 1305*2 California State Law, USA
Completed construction of Ube Plant office building with ZEB*3 certification*1: General Incorporated Association, Japan Center for Engagement and Remedy on Business and Human Rights*2: Mandatory Climate Change Disclosure for California-based Companies*3: Abbreviation for Net Zero Energy Building, a building that aims to reduce energy consumption to zero whileachieving a comfortable indoor environment.

tion of new modalities that can cure or control disease progression; thedepletion of monoclonal antibody and small molecule drug targets; anda shift in the pharmaceutical industry, including by Big Pharma, to strate-

Environmental changes since 2021–2025 MTBP planninggies targeting narrow treatment areas.
One of the main challenges the industry faces is reductions to drug
prices and tighter criteria for treatment reimbursements, meaning drug
companies increasingly have to set out clearer cases for patient value.
Given these developments, we recognized that we had to further
clarify Vision 2030 to achieve our objective of becoming a Japan-based
GSP capable of continuously creating life-changing value. The end result of
the review process is our Story for Vision 2030, released in February 2024.

03

Internal Change

External Change

Established global our own sales and marketing system for orphan drugs such as Crysvita
and Poteligeo.
Bone & mineral, intractable hematological diseases/hemato oncology, and rare diseases are
becoming disease areas of strength.
Acquired the modality of hematopoietic stem cell gene therapy, which has the potential toeliminate the underlying causes of inherited diseases.
Portfolio changes due to rocatinlimab value maximization, new asset acquisitions anddevelopment discontinuations.
Through the One Kyowa Kirin structure, an organization that can grow by incorporating
diverse skills and structures.

Global trend of tighter policies and regulations to reduce health care costs.
Growing demand for cure or controlled progression and for practical application of new modalities to meet those demand.
Decrease of druggable targets that can be addressed by monoclonal antibodies
or small molecules.
The entire pharmaceutical industry, including Megapharma, is adopting astrategy of focusing on pharmaceutical business and narrowing their focus
disease areas.

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CONTENTSINTRODUCTION

AT A GLANCETOPICS FORVALUE CREATIONTOPICS FORVALUE ENHANCEMENT

Story for Vision 2030

curing hereditary conditions with a single treatment. Orchard is a

The main thing we want to clearly communicate through this strategic­leading provider of HSC-GT and is building its track record in the field.

story is that Kyowa Kirin delivers life-changing value. The first objective of

The company has already launched an HSC-GT product to treat lysosomal

our drug discovery strategy – the source of this life-changing value – isdisease in Europe and acquired FDA authorization in the US. By integrat-

to focus more clearly on the Group’s target treatment areas and shift

ing our strengths in biopharmaceuticals with Orchard’s strengths inmodalities to advanced antibody technologies and HSC-GT. The second

gene therapy research, we aim to create life-changing value for unmet

is to further strengthen open innovation, partner collaboration, andmedical needs.

venture capital (VC) / corporate venture capital (CVC) activities.

FINANCIAL INFORMATIONCORPORATE INFORMATION

04

After the Orchard acquisition completed in January 2024, we set up a

To maximize life-changing value generated by this drug discovery

post-merger integration (PMI) team to rapidly capture synergies bystrategy, we will have to select the optimal business model in the devel-

integrating management infrastructure such as financing and compli-

opment and marketing stages. Two types of assets will be key. First,

ance. We have also continued to work on US approval for Orchard’s

assets in our target treatment fields – all the Group’s global assets from

OTL-200 therapy. Going forward, we will move into the full PMI phase,

R&D through to sales. Our main assets here are Crysvita and Poteligeo. In

prioritizing synergies in R&D and customer-facing operations.

Kyowa Kirin delivers
life-changing value.

the first half of the FY2021–2025 Medium Term Business Plan, we maximized the value of these drugs while putting in place our own global
sales structure. Other key assets are KK2845, a promising new bloodcancer drug scheduled to enter clinical trials in 2024, and products
under development by Orchard Therapeutics.
Second, strategic partnering assets – by leveraging external capabili-

Story for Vision 2030

Strategies for creating and delivering life-changing valueties, we will be able to build the best possible business models thatcombine our own strengths and those of our partners. These models willallow us to maximize the value of products derived from in-house

Disease Science

Vision 2030, we will pursue a range of initiatives, including in-licensing toFocus disease areas: bone & mineral, intractable hematological diseases/hemato
oncology, and rare diseases
Explore UMN, causes and mechanisms of disease in depth
Pursuit of molecular and cellular regulatory mechanisms for therapeutic
realization

reinforce our portfolio and investing in science and technology to build

Drug Discovery Technology

research and rapidly deliver value to patients. In line with our Story for

new strengths.

Integration of Orchard Therapeutics
Orchard’s gene therapy platform uses the patient’s own hematopoietic
stem cells (HSC). HSC are extracted and missing or faulty genes arecorrected before being transplanted back into the patient, potentiallyStrengthening Innovative Modalities: Advanced Antibody Technologies,­Hematopoietic stem cell gene therapy
Application of optimal modalities for therapeutic realization
Evolution of drug discovery methods through AI and data science

External Collaboration
Open Innovation
Partnering

Assets in focus
disease areas
Life-changing
Value Creation
Strategic
Partnering
Assets** Assets outside of the disease areas of focus are designated as strategic partnering assets, and value maximization is achieved
through collaboration with partners.

Valuedelivery on
our own

Global deployment of
products developed bytaking full advantage ofthe company’s strengths

Collaborative value
delivery

Aim to maximize value by
combining the strengthsof the company and its
partners

Full-­
licensingMaximize the value ofdeveloped products anddeliver them to patients
faster by out-licensing to themost appropriate partners

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CONTENTSINTRODUCTION

AT A GLANCETOPICS FORVALUE CREATIONTOPICS FORVALUE ENHANCEMENTFINANCIAL INFORMATIONCORPORATE INFORMATION05

A team committed to creating and providing
life-changing value

only integrating the strengths of each team member, but also by nurtur-and management, and an award system to recognize employees who

ing new strengths in them. To create this kind of team, we have toembody KABEGOE.

To realize our Vision, the strong commitment of every single Kyowa Kirin

strengthen the foundations that allow each employee to embody the

Building on the KABEGOE theme, we have positioned 2024 as aemployee will be the key factor for success in providing life-changing

values of Kyowa Kirin and to work on value creation using their diverse

year when the Group itself begins to overcome new barriers to growthvalue in line with our Story for Vision 2030. All of us at Kyowa Kirin,

strengths. This is where our global KABEGOE (meaning ‘overcomingby accelerating the pace of reform in order to realize Vision 2030.

including myself, have to be prepared to transform our behavior andbarriers’) activities play an important role, giving employees the skills to

Although the external environment is becoming tougher, we remain

evolve. We need to ask ourselves if our daily actions really are helping toovercome their own barriers. We completed our third year of KABEGOE

undaunted as we continue to transform Kyowa Kirin into a Japan-based

deliver value to patients. In short, we have to work tirelessly while also

activities in 2023, which covered a wide range of ongoing initiatives,

GSP that creates life-changing value. I am confident this approach will

looking for ways to improve. The ideal outcome of this would be theincluding workshops and action statements by management, meet-up

ultimately bring smiles to the faces of many people living with medical

formation of teams that continuously create life-changing value by not

and town hall meetings to foster direct dialogue between employees

conditions worldwide.

Our CxO team—leading Kyowa Kirin’s transformation into a Japan-based GSP
Kyowa Kirin needs a more independent, accountable and responsive business execution structure towith all related business functions now reporting to a single CxO. Led by the CEO, the CxO team will be

realize its Vision and drive growth as a Japan-based GSP. To address this, we have expanded our CxO team,responsible for accelerating decision-making and strengthening business execution.

Each CxO explains their policies and strategies on the following pages.

Masashi Miyamoto

Yutaka Osawa

Takeyoshi Yamashita

Motohiko Kawaguchi

Abdul Mullick

Yasuo Fujii

Shoko Itagaki

Toshiyuki Kurata

CEO

CCO

CMO

CFO

CIBO

CSO

CPO

CSCO

See page 37

See page 21

See page 14

See page 32

See page 25

See page 29

See page 38

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06

History of Value Creation
Kirin

Kirin

1885

Kirin

Establishment of the Japan Brewery
Company, the forerunner of Kirin
Brewery Co., Ltd.

Promoting open innovation

1982

Kirin Brewery decided to enter thepharmaceutical business
By 1982, calls within the company to diversify business had become louder. A new R&D
Department was established at the head office and a full-fledged pharmaceutical business waslaunched. The Research Institute for Production Development foundation began full-scale
research towards the commercialization of erythropoietin.

Kirin

1907

1984

In 1988, targeting future expansion into immunology research, the Company
supported the establishment of the La Jolla
Immunology Institute, one of the world’s
leading immunology laboratories. The
partnership, which continues to the presentday, went on to contribute to the discovery
of KHK4083. It has provided learning
opportunities for many of our researchers
to experience cutting-edge research.

Establishment of Kirin-Amgen

Establishment of technology for
producing fully human antibodies

Kirin-Amgen, Inc. (currently Amgen K-A, Inc.), a joint venture with U.S. company
Amgen, was established for the research and development of erythropoietin.
Kirin-Amgen later grew into a company that holds rights to major products withannual sales exceeding ¥1 trillion. This brought global recognition of Kirin’s
pharmaceutical business.

Human antibodies can be used in the treatment of infectious diseases, cancer, and otherdiseases. The development of technology to enable their mass production had beenlong awaited. Our researchers became the first in the world to devise Human Artificial
Chromosome (HAC) technology. They succeeded in developing mice that produce fully
human antibodies. This further expanded the pharmaceutical potential of antibodies.

Kirin

Establishment of
Kirin Brewery Co., Ltd.

1988

Kirin

2008

Launch of Kyowa
Hakko Kirin Co., Ltd.

Kyowa
Hakko

1949

Kyowa
Hakko

Establishment of Kyowa Hakko Kogyo Co., Ltd. as asecondary company of Kyowa Sangyo Co., Ltd, in
accordance with the Enterprise Reorganization Act
Kyowa
Hakko

1956

Succeeded in isolating andcommercializing the anti-tumor
agent Mitomycin C

1951

Kyowa Hakko entered thepharmaceutical businessAt a time when tuberculosis was considered a terminal disease, Kyowa Hakko had
been conducting research into streptomycin, an anti-tubercular drug. But we had
not been able to achieve the level of mass production that would make it
commercially viable. After introducing manufacturing technology from the U.S.
company Merck, we succeeded in mass-producing streptomycin for the first timein Japan. In doing so, we contributed to the eradication of tuberculosis in Japan.

Kyowa
Hakko

2003

Establishment of POTELLIGENT and BioWa
Having established POTELLIGENT, a breakthrough antibody production technology that dramaticallyincreases the activity of antibodies, Kyowa Hakko established BioWa, Inc. in the US in 2003 to start a licensing
business for this technology, out of a determination to help more people. Through their strong desire to
make use of this technology, the researchers overcome repeated challenges. This culminated in the creationof world’s first antibody drug utilizing POTELLIGENT, Poteligeo.

In October 2008, Kyowa Hakko Kirin was formed
through the merger of Kyowa Hakko Kogyo andKirin Pharma. This began the challenge of
becoming a Japan-based Global Specialty
Pharmaceutical Company (GSP)—with the aim of
becoming a world-class biotechnology R&D-driven
life science company.

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CONTENTS

Creation of
innovative drugs
We are striving to create innovative drugs andlife-changing value that brings smiles to people
living with medical conditions by leveraging
advances in antibody technology and drug
discovery capabilities from before Kyowa Kirin
was established.

INTRODUCTION

We are acquiring distribution networks andmoving into more markets to deliver our
medicines to even more patients worldwide.

2018
Launch of Fasenrain Europe, US, and JapanAt the time, Adult T-cell Leukemia-Lymphoma (ATL) was an incurable disease
for which there was no effective treatment. All those involved in the researchand development of this drug a steadfast determination to carry their efforts
through to completion, with the creation of a drug. In 2012, Poteligeo waslaunched as the world’s first antibody drug utilizing POTELLIGENT technology.

Fasenra is an antibody drug discovered by Kyowa Hakko and licensed to
AstraZeneca’s for development and marketing. It has grown to become one of
AstraZeneca’s blockbuster products.

2013
Launch ofNouriast in Japan2011

Acquired UK company ProStrakan as a
subsidiary2014

Acquired UK company Archimedes asa subsidiary2019

Launch of Nourianz in the US

2010

Completed construction of one of Japan’s
leading production facilities for drug substances
for antibodies at the Bio Process Research andDevelopment Laboratories.

2016

We are improving manufacturing technology andadding more production capacity to ensure thestable production and supply of high-quality
pharmaceuticals.

Reinforcing themanagement
infrastructure
As part of our efforts to become a Japan-based GSP,
we are maximizing the value of the Group’s tangible
and intangible assets through portfolio reshufflingand improvements to our management structure.

Completed construction of a new biopharmaceutical API manufacturing building at
Takasaki Plant, increasing production capacity.

2012

Establishment of Fujifilm Kyowa Kirin Biologics Co. Ltd.,a joint venture with Fujifilm Corporation.

2019

Kyowa Hakko Bio Co., Ltd. is transferred toKirin Holdings Company, Limited.

07

Concluded an agreementwith Amgen for joint
development and marketingof KHK4083/AMG 451.

2023

Acquired Orchard Therapeutics plc, aleading provider of hematopoietic
stem cell gene therapy (HSC-GT).

2023

Started sales of Crysvita through proprietary channels in North America, taking over­commercial activities from Ultragenyx Pharmaceutical Inc. after a five-year collaboration.

2023

Formed joint venture with Grünenthal in the established medicines business, allowing theCompany to focus management resources on Crysvita and Poteligeo.

2020

CORPORATE INFORMATION

X chromosome-linked hypophosphatemic rickets (XLH) is a rare disease that
affects 1 in 20,000 people. Previously, patients had suffered from growth failure
and pain that kept them awake at night, withtreatment limited to symptomatic therapy. Patientswith this genetic disease have suffered acrossgenerations, with both parents and children affected.
Crysvita became the first essential treatment for XLH,
for which there had been no adequate therapy.

Launch of Crysvita in Japan

2018

FINANCIAL INFORMATION

2021

2018
Launch of Crysvita in Europe
and the US

2019

Launch of Poteligeo in the US

Quality assurance
and a stable supplyof products

TOPICS FORVALUE ENHANCEMENT

2012
Launch ofPoteligeo in Japan

With dopaminergic drugs dominating the mainstream, the research anddevelopment into this non-dopaminergic drug had presented a series ofchallenges. The project was encouraged by a corporate culture of embracing
challenges. In 2013, the effort finally bore fruit.

Maximize productvalue Access to
medicine

TOPICS FORVALUE CREATION

AT A GLANCE

2023

To The Future

Poteligeo (sold in
39 countries /regions worldwide)

Our challenge
continues into
the future

Crysvita (sold in
46 countries /regions worldwide)

Launch of Poteligeo in Europe

2018

Realignment of domestic production
sites completed

2019

Formulated Global QA Road Map through 2025
and started strengthening related systems

2022

Completed rollout of global quality management
system (eQMS)

2022

Completed new quality assurance center Q-TOWER
at Takasaki Plant

2019
Launch of the
One Kyowa Kirin structure2021
Evolution of the One
Kyowa Kirin structure

In response to the growth of global strategic products, Kyowa Kirin launched a matrix
management structure combining the regional organizations of Japan, EMEA, North
America, and APAC with functional organizations that transcend regions. The close
collaboration and checks and balances between the two types of organizations havemade it possible to improve operational efficiency and strengthen governance.

To strengthen activities with a greater focus on patients,
a product organization was added to the regional andfunctional organizations. We aim to further maximize
the value of our global strategic products.

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AT A GLANCETOPICS FORVALUE CREATIONTOPICS FORVALUE ENHANCEMENTFINANCIAL INFORMATIONCORPORATE INFORMATION08

Our Philosophy and Core ValueOur Philosophy

The Kyowa Kirin Group companies strive
to contribute to the health and wellbeingof people around the world by creating
new value through the pursuit of advancesin life sciences and technologies.

Transform lives with passion and excitement.
Challenge the status quo in all of our work.

Core Values

Work for the most precious presenceon this planet.
Create value for patients, caregivers,
healthcare professionals,
and customer.
Do the right things.

One for all, all for one.

Be sincere and ethical consistently.

Work in diverse teams and respect each other.

Make a better world through goodbusiness practices.

Go beyond boundaries and collaborate
with stakeholders.

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Our Vision toward 2030
Kyowa Kirin will realize the successful creation anddelivery of life-changing value* that ultimately
makes people smile, as a Japan-based Global Specialty
Pharmaceutical company built on the diverse team ofexperts with shared passion for innovation.
* Make patients smile through dramatic improvements in quality of life byidentifying the unmet medical needs of people battling with medical
conditions and by creating and supplying new drugs or services that help
them overcome those challenges.

Providepharmaceuticals for
unmet medical needs
We are focused on developing medicines
for diseases where there is a clear
patient need for new options. We make fulluse of multiple therapeutic modalities,
including biotechnology such as antibody
technology, and beyond, building on
our Kyowa Kirin established strengths.

Address patient-centric
healthcare needs
We will meet the needs of patientsand society by providing value across theentire patient care pathway, delivering
cutting-edge science and technology,
grounded in our in-depth pharmaceuticalknowledge and expertise.

Retain the trust ofsociety
We pursue world-class productquality and operational excellence togrow our business in ways whichbuild long-term trust with
our stakeholders.

09

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Strategies and Challenges for Achieving Our Vision
In the midst of major environmental changes, we formulated the Story for Vision 2030 to further ensure the realization of our vision. While increasing the resolution of the vision,
we will link strategies and issues more organically and implement CSV management for the creation of life-changing value.

Philosophy

Story for Vision 2030

Vision 2030

Strategies for creating and delivering life-changing value
Disease Science

Focus disease areas: bone &mineral, intractable hematological diseases/hemato
oncology, and rare diseases

Drug Discovery
Technology

Strengthening Innovative
Modalities: Advanced Antibody
Technologies, Hematopoietic
stem cell gene therapy

External
Collaboration

Assets in focus
disease areas

Value
delivery on
our own
Collaborative value
deliveryLife-changing
Value Creation
Strategic
Partnering
Assets*Clarified our
objectives toensure Vision
2030 is realized

Providepharmaceuticals
for unmet
medical needs

Kyowa Kirin will realize the successful creationand delivery of life-changing value that­ultimately makes people smile, as a Japanbased Global Specialty Pharmaceutical­company built on the diverse team of experts
with shared passion for innovation.

Addresspatient-­centric­healthcare needs

Retain the trustof society

Key issues to be addressed to realize the vision
Full-­
licensing* Assets outside of the disease areas of focus are designated as strategic partnering assets, and value
maximization is achieved through collaboration with partners.

Materiality
Topics for value creation Creation of innovative
drugs

Maximize product value
Pipeline enrichment Access to medicine
Create healthcare solutions beyond medicines Talent portfolio Corporate culture

CSV management Digital transformation

Topics for value enhancement Quality assurance and a supply of products Reducing environmental impact Corporate governance Ethics and transparency Reinforce risk management

10

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CONTENTSINTRODUCTIONTOPICS FORVALUE CREATION

AT A GLANCETOPICS FORVALUE ENHANCEMENTFINANCIAL INFORMATIONCORPORATE INFORMATION

Value Creation Story
In order to make people facing illness smile, we will create social and economic value by utilizing our human and intellectual capital, which are the source of ourcompetitiveness, and by ensuring that all employees prioritize patient centricity, and by creating value together with various stakeholders through mutual
collaboration in the processes of research and development, product, quality, distribution and drug delivery.

CSV Management
Creation of social and economic
value with stakeholders
Sources of ourcompetitivenessEmployees who share Kyowa
Kirin’s vision and values A strong, diverse teamIntellectual capital Breakthroughs and expertise indisease science

Continuously create and­provide life-changing value
Provide new and better
treatment options thatmeet patient expectations(new drug launches,­additional indications /formulations, etc.)

Patient
Centricity KABEGOE* corporate culture Advances in antibody technology
and incorporation of various
modalities

Social value

Value creationin the process ofdelivering­medicines topatients

Human capital

Value creationin products,
quality anddistribution

OutputValue creation
to meet UMN
through R&D Integration of internal and­external innovations

Deliver essential medicines to more patients(increase number oflaunch markets, etc.)
Ensure stable supplies ofpharmaceuticals

Economic value Revenue* Reforms to the Group’s corporate culture
launched in 2019 Revenue growth rate
 Core operating profit

Management Philosophy /Core Values Core operating profit ratio ROE

OutcomeBringing smiles topatients leads tosatisfaction for
employees as well

11

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AT A GLANCETOPICS FORVALUE CREATIONTOPICS FORVALUE ENHANCEMENTFINANCIAL INFORMATIONCORPORATE INFORMATION

12

Materiality
Kyowa Kirin has identified materiality (key management issues) to realize its vision for 2030.
In 2022 we clarified the link between the Group’s materiality and our vision and business strategy. In 2024, in light of changes in the operating environment, we reviewed the Group’smateriality again when formulating our forecasts for FY2024.
Going forward, the whole Group will continue to work as one to realize our vision for 2030.

Topics for value creation
Core strategies

Providepharmaceuticals
for unmet
medical needs

Addresspatient-centric
healthcare
needsStrengthen
human resources
and infrastructure
to realize lifechanging value

Materiality

Topics for value enhancement
Related SDGs

Core strategies• Creation of innovativedrugs• Maximize product value• Pipeline enrichment

Retain the trustof society

Materiality• Quality assurance and a
supply of products• Reducing environmental
impact• Access to medicine• Create healthcare solutions
beyond medicines• Talent portfolio• Digital transformation• Corporate culture

Strengthen
human resources
and infrastructure
to realize lifechanging value• Corporate governance• Ethics and transparency• Reinforce risk management

Related SDGs

Kyowa Kirin Co., Ltd.
Integrated Report 2023

CONTENTSINTRODUCTIONTOPICS FORVALUE CREATION

AT A GLANCETOPICS FORVALUE ENHANCEMENTFINANCIAL INFORMATION

13CORPORATE INFORMATION

Co-creating Value with Stakeholders
To realize our Vision for Kyowa Kirin, we need to create both social and economic value. An essential part of this process is cooperating and collaborating with stakeholders in the value
chain. We are committed to mutual understanding and deepening our relationship with stakeholders through various communication opportunities.

Stakeholders

Patients, caregivers, patient communities Disease and health information websites Medical information contact center Patient advocacy activities

Ongoing
Ongoing
Ongoing
Ongoing
Ongoing

Healthcare professionals Medical websites Medical information contact center Publication of medical findings in journals andat conferences Communication via MR/MSL

Employees Internal intranet Whistleblowing system*1 Awards for employees Employee engagement survey Interviews with superiors and team members Labor-management talks

Ongoing
Ongoing
1 time1 timeOngoing
Ongoing

Partners(Suppliers, pharmaceutical wholesalers, etc.) Supplier briefings Sustainable procurement questionnaire Collaboration on business transactions

1 time1 timeOngoing

Joint R&D partners Partnerships in pharmaceutical research anddevelopment

Ongoing

Shareholders / investors*2 General meeting of shareholders Financial results briefings IR events for R&D and ESG topics President IR interviews IR interviews by senior managers IR interviews by IR staff

1 time4 times
3 times
25 times
31 times
132 times

Industry associations, central and local­governments, regulators / payers Advocacy and collaboration through industry bodies

Ongoing

Communities Initiatives to support communities Dialogue with local residents

Ongoing
Ongoing Initiatives to support communities Climate change response and other environmental
measures

Ongoing

Future generations / environment

People facing illness
Patients,
caregivers, patientcommunities

Healthcare
professionals

Life-changing value

Community, Environment
Communities

Patient-centric

Futuregenerations /environment Coexisting with local
communities

Work engagement
Skills development Reducing environmental
impactPolicymakers, industry
associations
Industry
associations

Business partners

CentralRegulators /and local
payersgovernments Improving QOL of patients byproviding appropriate medicines Maintain and improve the publichealth care system

Employees
Employees

Capital providers
Shareholders / investors Increase corporate value Shareholder returns

Partners (suppliers,
pharmaceuticalwholesalers, etc.)

Joint R&D
partners Equitablebusinesstransactions Co-creation oflife-changing
value

Main communication opportunities and frequency*1 The Company has also established a whistleblower system for stakeholders as part of its grievance mechanism.
*2 See P48 for more details on our shareholder and investor initiatives.

Ongoing
Ongoing

OngoingKyowa Kirin Co., Ltd.
Integrated Report 2023

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14

Financial Strategy
Medium Term Business Plan progress review

CFO Message
We will continue todeliver life-changing valuethat makes people smile,
supported by like-minded
colleagues working
toward our shared visionand goals.

Motohiko Kawaguchi
Managing Executive Officer,
Chief Financial Officer (CFO)

Under the FY2021–2025 Medium Term Business Plan, our main objective is toestablish a stable earnings structure and deliver sustained growth as a Global
Specialty Pharmaceutical Company. We aim to do this by sustainably boosting
growth, innovation and profitability to support medium- and long-term improvement in return on equity (ROE) and continuous increases in the dividend. We
employ five key performance indicators (KPIs) to objectively measure progress
toward the plan’s goals: ROE, revenue growth, the R&D expenses ratio, the core
operating profit ratio and the dividend payout ratio.
We took a number of steps in FY2023 to maximize the value of global strategic
products such as Crysvita and Poteligeo. For example, in the US we began proprietary sales of Crysvita, while in Europe we formed a partnership in our establishedmedicines portfolio, allowing us to focus more on Crysvita and Poteligeo. In termsof R&D, we continued to push ahead with the development of KHK4083 (rocatinlimab) in the immunological and allergic disease treatment field, including multiple
clinical trials with US development partner Amgen Inc. In Japan, we decided to
discontinue the development of RTA 402 in the renal disease treatment field, but
we received manufacturing and marketing approval for PHOZEVEL for the improvement of hyperphosphatemia in chronic kidney disease patients on dialysis.
In the FY2021–2025 Medium Term Business Plan, we are targeting sustained
growth and higher corporate value over the medium to long term, using ROE as
the KPI. Our aim is to rapidly achieve ROE of 10% or higher so that it consistently
exceeds the expected cost of capital. We also aim to increase ROE over the longer
term. In FY2023, we reported record profits and ROE of 10.2%, achieving ournear-term ROE target. We also attained our target for revenue growth of 10% or
higher (CAGR versus FY2020 base year) with growth of 11.6%. However, theGroup’s profit structure deviated from our FY2025 objectives, with the R&D

Financial KPIs (Numerical guidance)
ROE
Revenue growth
ratio

ROE

CAGR*1 10% or higher

R&D expenses ratio Targeting 18–20% to support active investment
Core operating
profit ratio*2

25% or higher by 2025

Dividend payout
ratio

Targeting sustained dividend hikes with 40%(based on core EPS*3)*1 Average growth rate over a five-year period, with FY2020 as the base year.
*2 Core operating profit: “Gross profit” – “Selling, general and administrative expenses” –“Research and development expenses” + “Share of profit (loss) of investments accounted forusing equity method.”*3 “Core profit” (“Profit attributable to owners of parent” – “Other income and expenses”­(excluding impact from applicable taxes)) / average number of shares during fiscal year.

ROE

7.3%

10% orhigher
ROE

ROE

7.6%

7.1%
Revenue

Revenue¥473.0 billion
Revenue ¥442.2 billion
Revenue ¥398.4 billion
2020➝
2020
➝2024
¥352.2 billion
2020➝
2020
➝2023
CAGR11.6%

35%
16%
19%
2021

Cash allocation
In our five-year cash allocation plans in the FY2021–2025 Medium Term Business
Plan, we assume the source of funds will be new operating cash flow of ¥800
billion or higher (before deduction of R&D expenses) generated during the plan’s
five years, in addition to cash on hand. Our top priority for cash allocation is
growth investments (such as R&D, strategic investments and capex), in order tosustain growth beyond FY2025 and maximize corporate value.

ROE

10.2%

10% or higher (achieve target early / maintain or
increase over the medium- to long-term)

expense ratio at 16.3%, compared with our target of 18–20%, and the core operating profit ratio at 21.9%, versus our target of 25% or higher. Additionally, to ensure
the Group continues to create life-changing value, we need to reconfigure ourbusiness model to adapt to changes in the operating environment, among othersteps. Specifically, following the acquisition of Orchard Therapeutics plc (Orchard)
and the discontinuation of some development work, we recognize that the Groupneeds to further increase R&D spending and strategic investment. In light of this,we decided to extend the timeframe for our KPIs, including ROE of 10% or higher,
to FY2026 and beyond.
In FY2024, we will continue to expand our business regions and market reachto maximize the value of global strategic products such as Crysvita and Poteligeo.
In Japan, sales of G-Lasta are likely to decline due to the impact of biosimilars, but
we will focus on increasing market uptake of new products such as PHOZEVEL. In
R&D, we will continue to develop next-generation global strategic products suchas KHK4083, while also stepping up investment in hematopoietic stem cell genetherapy through the consolidation of Orchard. With these initiatives, we are targeting revenue growth of 10.4%, an R&D expenses ratio of 21.1%, a core operating
profit ratio of 18.0% and ROE of 7.6% in FY2024.

CAGR10.4%

Revenue
growth ratio

CAGR 10% or
higherCore operating
profit before R&D

43–45%
R&D

38%
16%

38%
16%

39%

22%

22%

18%

25% or higher

2022

2023

2024 (Plan)

2025 (MTBP)

21%

18–20%

Core operating
profit*4 Above graph is taken from the Results Presentation FY2023, released February 7, 2024

 Steady growth in Crysvita sales Collaboration with Amgen on
KHK4083 Depreciation of Yen Short term financial impact on
Orchard acquisition Increasing investment in KHK4083
development Depreciation of Drug priceenvironment (Japan, Europe,and China) Unlaunched new products(discontinued pipelines,
Nourianz in Europe)2025 MTBP
financial KPIs
Achievementtiming will be
2026 or beyond

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CONTENTSINTRODUCTION

R&D investment
During the FY2021–2025 Medium Term Business Plan, our goal is to consistently
invest 18–20% of revenue in R&D and we plan to spend a substantial ¥100 billion in
FY2024 (projected R&D expenses ratio of 21%). Specifically, we will invest resourcesin the continued development of next-generation products such as KHK4083 andKHK4951, R&D for early-stage development drugs such as KK2260 and KK2269—­
created with our proprietary Regulgent bispecific antibody technology—andantibody-drug conjugate (ADC) KK2845, while also acquiring new pipeline products.
These efforts will support the continued development of innovative new drugs. In
terms of drug discovery technology, we will invest to enhance innovative modalities, such as leveraging our proprietary advanced antibody technologies andOrchard’s hematopoietic stem cell gene therapy technology.

Strategic investment
We will actively utilize external resources for strategic partnering (in-licensing,tie-ups, etc.) and M&A to tap external innovation, such as drug discovery technologies created through open innovation and new compounds for our pipeline. We arealso targeting faster, sustained growth by expanding our pipeline over the medium
and long term and by generating synergies with existing global strategic products.
The Strategic Investment Review Committee, which is led by the CEO and meets
monthly, proactively considers potential targets for strategic growth investments.
Priority is given to the strategic investment projects shown in the box below.
In FY2023, we agreed to acquire Orchard, a global leader in hematopoietic

Operating cash flow
before deduction of
R&D expenses:¥800 billion or higher(Operating CF + R&D expenses)(at the end of 2020)+ Borrowing capacity

R&D investment:

Shareholder
returns

Cash on hand
Approximately¥300 billion

TOPICS FORVALUE ENHANCEMENTFINANCIAL INFORMATIONCORPORATE INFORMATION

15

stem cell gene therapy, for $478 million. The acquisition closed in January 2024. In
February, we concluded a license agreement with BridgeBio Pharma, Inc. todevelop and commercialize infigratinib in Japan for an upfront payment of $100
million. Infigratinib is targeting bone & mineral areas.

region), which reflects the expected cost of capital (WACC) for investors. In investment decisions, we focus on whether the investment will contribute to an increasein corporate value over the medium to long term by generating returns in excessof the cost of capital.

Capital investment (capex)

Shareholder returns

We are investing heavily to create a more competitive business structure to help
maximize the value of global strategic products. In particular, we are working toestablish a robust quality assurance and production system and strengthening
supply chain management to ensure stable supplies of safe, reliable-quality pharmaceuticals to patients worldwide. We also aim to rapidly establish a global businessbase that supports Kyowa Kirin’s sustained growth as a Japan-based GSP, including
building a platform that allows us to strategically leverage IT and digital tools.
Capital investment in FY2023 totaled ¥23.2 billion (including intangible assets
and long-term advance payments). To ensure stable supplies of pharmaceuticals
with reliable quality, investment was mainly used for new facilities at Takasaki
Plant—completion of a new quality assurance center (Q-TOWER) equipped withthe latest equipment (investment of ¥14.0 billion), a new active pharmaceuticalingredient (API) manufacturing facility (¥16.8 billion), and a warehouse building(¥7.2 billion).
When evaluating the profitability of potential investments or development
projects, we mainly use two quantitative standards: net present value (NPV) and
expected present value (EPV). Both standards are based on the hurdle rate (byIn the FY2021–2025 Medium Term Business Plan, we are targeting a consolidated
dividend payout ratio of 40% based on core EPS, aiming to steadily increase returns
for investors by raising the dividend in line with profit growth over the medium tolong term. Based on that policy, we paid an FY2023 dividend of ¥56.00 per share(dividend payout ratio of 35.5%), an increase of ¥5.00 from FY2022. In addition, weplan to raise the dividend to ¥58.00 (dividend payout ratio of 47.6%) in FY2024,
which will be the eighth consecutive increase. In February 2024, the Company
decided to repurchase and retire up to ¥40 billion of its own stock (17 million shares)
to improve capital efficiency and increase shareholder returns, in line with its policyof flexibly considering buybacks, taking into account the share price and otherfactors. The share repurchase began the same month.
To generate sustained growth and maximize corporate value as a Japan-based GSP,
we will enhance the Group’s growth potential, capability to innovate, and profitability in order to improve ROE over the medium to long term and support sustained
increases in the dividend.

Dividends per Share / Payout Ratio*2(Yen)(%)

Allocation
Growth investment

Cash to be newly generated
during the FY2021–2025
MTBP (cumulative)

TOPICS FORVALUE CREATION

Strategic Investment

Cash Allocation*1
SourceAT A GLANCE

Approximately ¥400 billion(R&D expenses ratio of 18–20%)

Strategic investment(Pipeline, drug discovery technology, etc.)

CAPEX: Approximately¥100 billion(Stable global production and supply-chain
framework, IT/digital investment, etc.)

Dividend(Core EPS-based payout ratio of 40%)

Share repurchases(Flexible approach)Prioritize growth investments that will sustain growth and maximize corporate value from2025 onwards
Target sustained increases in the dividend in line with profit growth over the medium- tolong-term and consider buying back shares on a flexible basis*1 Medium Term Business Plan (2021–25) cash allocation assumptions announced on February 4, 2021

Licensing-in and M&A investments to strengthen
the portfolio
Priority will be given to the focus disease areas bone & mineral intractable hematological diseases/hemato oncology rare diseases

Investment in science and technology to create
new strengths Investments aimed at acquiring new drug discovery technologies and early pipelines and accelerating cooperation andcollaborations VC investment and CVC activities for exploring and accessing
information.

90

60

50.3
43.2

60

34.4 35.2 33.7
35.0

30

27.0
14.5

0

20.0

12.5

15.0

2017

2018

47.6
38.9
51.0

56.0

58.0

44.0

46.0

22.0

22.0

23.0

20.0

22.0

23.0

24.0

27.0

29.0

2019

2020

2021

2022

2023

2024

42.0

27.0

35.5
29.0

40

29.0
20

(Plan)

0

Dividends per Share (interim) (left scale)
Dividends per Share (annual) (left scale)
Payout ratio (right scale)*2 Dividend payout ratio after 2021 is the dividend payout ratio based on core EPS(= Profit attributable to owners of parent – Other income & expenses and impact of applicable taxes).

Kyowa Kirin Co., Ltd.
Integrated Report 2023

AT A GLANCECONTENTSINTRODUCTION

AT A GLANCETOPICS FORVALUE CREATIONTOPICS FORVALUE ENHANCEMENTFINANCIAL INFORMATIONCORPORATE INFORMATION

Headline News

Providepharmaceuticals
for unmet
medical needs

April 2023

September 2023

January 2024

February 2024

March 2024

Started R&D collaboration with Tokyo Instituteof Technology’s Schoolof Life Science andTechnology into drug
discovery technology

Obtained partial change approval for
Romiplate® for treatment of aplastic anemia

Announced license agreement with
­Boehringer Ingelheim to develop newcompound as part of commitment topeople living with fibro-inflammatory
diseasesAnnounced partnership with BridgeBio
Pharma, Inc. granting Kyowa Kirin
exclusive license for infigratinib fortreatment of skeletal dysplasias in Japan

Received Drug Research andDevelopment Award fromPharmaceutical Society of Japanfor research and development ofanti-FGF23 antibody burosumab

January 2024 See P22 for more details

February 2024

September 2023

April 2023
Began sales of Crysvita in North America
through proprietary channels

May 2023
Discontinued development of bardoxolone methyl (RTA 402)

July 2023
Launched sales of mitomycin C as topicalophthalmic agent in Japan and resumed
sales of mitomycin C as anticancer
treatment

Addresspatient-centric
healthcare needs

Strengthen
human resources
and infrastructure
to realize
life-changing
value

Presented results of domestic Phase 3
clinical study of KW-3357 in patientswith preeclampsia; decision taken to
discontinue development

October 2023
Announced
agreement toacquire Orchard­Therapeutics plc

Completed acquisition of Orchard
Therapeutics

Launched PHOZEVEL® Tablets fortreatment of hyperphosphatemia

February 2024

March 2024

Orchard Therapeutics announces first
patient randomized in registrational trialof OTL-203 for MPS-I Hurler syndrome

November 2023

February 2024

Launched sales of calcium-sensing
receptor agonist Orkedia® Tablets 4 mg

Started international Phase 2 clinical trial
evaluating tivozanib eye drops in patientswith diabetic macular edema

October 2023

December 2023

Hosted discussion groupcalled XLH Café to support
patients and families affectedby X-linked hypophosphatemia rickets and osteomalacia

Released results of follow-up
questionnaire on Kurukotsu
Hiroba helpline for patientsand families affected by
FGF23-related hypophosphatemic rickets and osteomalacia

Retain thetrust of society

Orchard Therapeutics receives FDA
approval for Lenmeldy™, the only
therapy in the US for children withearly-onset metachromatic
leukodystrophy

March 2023

April 2023

May 2023

ZEB-certified officebuilding completed
at Ube Plant

Introduced
RE100-standard
renewable energy for
all electricity purchased by two plants
and three R&D sites

Started operation of Takasaki
Plant’s Q-TOWER, a new
quality assurance center

See P37 for more details

November 2023

November 2023

March 2024 See P31 for more details

Awarded gold status in the PRIDE Index (Japan)
as an LGBTQ+-friendly workplace for the second
consecutive year

Formulated multi-stakeholder policy

Certified as Health & Productivity Management Outstanding
Organization (White 500) for eighth consecutive year

16

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17

Financial Highlights

Key Points

Revenue

Overseas Revenue/Overseas Revenue Ratio

R&D Expenses/R&D Expense Ratio(Billions of yen)(Billions of yen)

(Billions of yen)

500

442.2

Revenue
Revenue rose year on year, supported by growth for
global products, especially in North America, and anincrease in technology out-licensing revenue. Foreignexchange rates lifted revenue by ¥18.9 billion.

473.0

400

400
318.4

352.2

300

151.7

54.0

243.7

2021

2022

2023

2024

0

(Forecast)Core Operating Profit/
Core Operating Profit Ratio

190.3

25

2020

2021

(%)
60

60.0

2022

2023

2024

(Forecast)

18.8

65.7

18.6

40

(Billions of yen)

2020

2021

2022

Core Operating Profit (left scale)Core Operating Profit Ratio (right scale)

2023

15.8

0

52.3

57.7

62.9

16.3

100

15

72.1

10

30
0

20

5
2020

2021

2022

2023

2024

(Forecast)

0

Cash Dividends/Payout Ratio*(Yen)(%)
(%)

100

20

18.0

20

16
63.0

60
40

47.0
6.8

52.3

53.6

7.3

7.1

10.2

80

100

2024

(Forecast)

0

0

2021

2022

44
40

7.6

50.3

46
43.2

51

2023

Profit Attributable to Owners of Parent (left scale)ROE (right scale)2024(Forecast)

0

56

58

50

35.5

20

0

75

47.6
38.9

8
4

2020

60

12

20
0

16.4

R&D Expenses (left scale)
R&D Expense Ratio (right scale)

80

85.0

21.9

16.4

25

81.2

40

21.8

120

60

Profit Attributable to Owners of Parent/
Return on Equity (ROE)(Billions of yen)
120

80

21.1

90

Overseas Revenue (left scale)
Overseas Revenue Ratio (right scale)

86.7

Net profit increased year on year, reflecting thehigher core operating profit, as well as an increase inother income due to gains on the sale of shares andon the valuation of residual equity interest following
the adoption of a joint-venture business structure forestablished medicines in Europe, and a decline inother expenses due to a drop in impairment losses.

75

65.3

100

2020

150

50

96.8

Profit Attributable to Owners of Parent

69.9

61.2
47.7

200

0

288.8

300

100

Despite higher R&D expenses and a decline in shareof profit (loss) of investments accounted for using
equity method, core operating profit increased year
on year, supported by a rise in gross profit due tohigher overseas revenue and technology out-­
licensing revenue. Foreign exchange rates lifted core
operating profit by ¥6.5 billion.

100

(%)

330.8

398.4

200

Core Operating Profit

(%)

25

2020

2021

2022

2023

2024

(Forecast)

0

Cash Dividends (left scale)
Payout Ratio (right scale)* Dividend payout ratio after 2021 is the dividend payout ratio based on core
EPS in the Medium Term Business Plan (2021–25).

Kyowa Kirin Co., Ltd.
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CONTENTSINTRODUCTIONTOPICS FORVALUE CREATION

AT A GLANCETOPICS FORVALUE ENHANCEMENTFINANCIAL INFORMATIONESG Highlights

Water Use*1(t-CO2)(t-CO2/hundred million yen)(Thousand m3)(Thousand m3/hundred million yen)

4,000 0.73

0.8

20

17.0

90,00015

12.9

41,074 38,299
34,68730,00023,889 21,897

0.55

3,000

10

7.6

1,746 1,672

2,000

0.6

0.47

2,229

10.9
60,000 51,931

0.37
1,489

5.3

30,162

23,3695

Ratio of Workers with Disabilities*4

(%)

(%)

2.5

3.0

2.0 All-industry
Average
1.80

2020

2021

2022

2023

2030

(Target)1,337

Scope 1 (left scale)
Scope 2 (left scale)CO2 emissions per unit of net sales (right scale)

2020

2021

2022

2023

2.59

2.45

2.43

2.45

2021

2022

2.56

Statutory
Requirement

2.30

2.20

2.0

1.0
0.2

0 2019

2.06

0.4

0.32

1,000

0

1.95

2.09

1.5

1,433

13,941 23,586
6,742

Accident Frequency Rate*2, 3

0.5

0.13
(1)

0

2019

17,244 17,185 16,402 16,221 16,844
0 201918

Please see ESG Data Collection for details.
https://www.kyowakirin.com/sustainability/esg_data/index.html

CO2 Emissions*1
120,000

CORPORATE INFORMATION

2030(Target)

0

1.0

0.39
(4)

0.10
(1)

0.09
(1)

2022

2023

0.00
(0)
2020

2021

0

2019

2020

2023

Water Use (left scale)
Water Use per unit of net sales (right scale)

Accident Frequency Rate
The numbers in parentheses are the number of accidents that
required time off from work.

Number of Employees/
Ratio of Overseas Employees

Number of Female Managers/
Ratio of Female Managers*5

Number/Percentage of mid-career hires*5

Employee survey positive response rates*6(Persons)(%)(%)(Persons)(%)(Persons)(%)

8,000

40.0

4,000

30.9
30.0
29.3
28.0
27.9
5,752 5585,982 5585,974 30.0
5,267 5,423 534
553
729
508
459
758
638
658
716
560
435
348
300
20.0

2,000

3,792

3,909

4,025

4,135

4,225

0

2019

2020

2021

2022

2023

6,000

Japan
North America
EMEA
Asia/Oceania
Ratio of Overseas Employees (right scale)

200

178
142

150

123
103

100

10.0

50

0

0

12.4

11.2

18.0

2020

2021

150
13.4

2022

Number of Female Managers (left scale)
Ratio of Female Managers (right scale)*1 Covers plants and research laboratories worldwide.
*2 Covers all locations of Kyowa Kirin in 2019 and 2020, and all locations in Japan and overseas plants/
laboratories of the Kyowa Kirin group from 2021.

400
61.0

14.8

9.7

2019

20.0

2023

2025

(Target)

15.0

300

10.0

200

5.0

100

0

0

66.3

163

69.0

66.8

80.0

2020

67

68

61

63

64

2019

2020

2021

64
60.0

60.0

40.0

40.0

20.0

20.0

0

0

70

70

68

69

2022

2023

201

189

152

2021

80.0

62.8

89

2019

Kyowa Kirin Group (Japan)

2022

Number of mid-career hires (left scale)
Percentage of mid-career hires (right scale)*3 The rates indicate the number of casualties from fatal lost-time accidents per million working hours.
*4 As of June each year.
*5 Covers Kyowa Kirin

2023

Employee engagement
Working environment*6 Responses to each question based on 5-point scale from “very much agree” to “do not agree at all,”with “very much agree” and “agree” being positive responses; positive response rates of 65% or higher
are generally considered to show the strengths of a company.
Different standards are used to calculate each figure for 2019 and 2020, and for 2021 and beyond.

Kyowa Kirin Co., Ltd.
Integrated Report 2023

CONTENTSINTRODUCTION

AT A GLANCETOPICS FORVALUE CREATIONTOPICS FORVALUE ENHANCEMENTFINANCIAL INFORMATIONCORPORATE INFORMATION

19

Pipeline (As of December 31, 2023)
small moleculelarge molecule

Code Name (Generic Name)<Formulation>

AMG531(romiplostim)<Injection>

antibody

Updated since Dec. 31, 2022

Mechanism of Action

Thrombopoietin
Receptor Agonist

KW-3357
Recombinant Human(antithrombin Gamma)
Antithrombin<Injection>

Updated since Sep. 30, 2023

Indication

Aplastic Anemia Who Were Previously
Untreated with Immunosuppressive Therapy
Disseminated Intravascular
Coagulation, Congenital
Antithrombin Deficiency

Ph I

Stage
Ph II

[In-House or Licensed]
Remarks

Ph III[Amgen K-A]
Ph II/Ph III product name in Japan: Romiplate
Area of clinical study: Asia
[In-House]product name in Japan: Acoalan
Area of clinical study: EU and UK

Anti-OX40 Fully Human
Atopic Dermatitis
Antibody[In-House]
POTELLIGENT
Fully human antibody production technology
Collaboration agreement with Amgen for the development of KHK4083/AMG
451 in all the countries except for Japan.
Clinical study is being conducted in JP, NA, EU, UK, Middle East, Asia, Oceania,
and other regions as a global product

KK2260<Injection>

EGFR-TfR1
Bispecific Antibody

Solid Tumor[In-House]
Bispecific Antibody with REGULGENT technology
Fully human antibody production technology
Clinical study underway in JP as a global productPreparations underway for PhI in NA

KK2269<Injection>

EpCAM-CD40
Bispecific Antibody

Solid Tumor[In-House]
Bispecific Antibody with REGULGENT technology
Fully human antibody production technology
Preparations underway for PhI in JP and NA as a global product

KK4277<Injection>

Anti-PTPRS Humanized Systemic Lupus Erythematosus/Cutaneous
Antibody
Lupus Erythematosus[SBI Biotech]
POTELLIGENT
Clinical study is being conducted in JP and Asia

KHK4951 (tivozanib)<Ophthalmic>

VEGF Receptor Tyrosine Neovascular Age-Related Macular
Kinase Inhibitor
Degeneration[In-House]
Clinical study underway in JP as a global productPreparations underway for PhIIKHK4083/AMG 451(rocatinlimab)<Injection>

Glossary
Phase I Clinical Trial Studies in small numbers of healthy people (patients in some cases) to verify safety issues including side effects.
Phase II Clinical Trial Studies in small numbers of patients to verify effective and safe dosage and regimen.
Phase III Clinical Trial Studies in large numbers of patients to confirm efficacy and safety in comparison with standard drugs or placebo.
* All trials are conducted under supervision of clinical doctors and with the consent of participants.

Kyowa Kirin Co., Ltd.
Integrated Report 2023

CONTENTSINTRODUCTION

AT A GLANCETOPICS FORVALUE CREATIONTOPICS FORVALUE ENHANCEMENTFINANCIAL INFORMATIONCORPORATE INFORMATION

HSC-GT

Reference Data: Orchard Therapeutics’ Development Pipeline
Code Name (Generic Name)

Indication

PoC study

Stage
Pivotal study

Remarks

Application

OTL-200(atidarsagene autotemcel)

Metachromatic Leukodystrophy

product name in EU: Libmeldy
HSC-GT
Under Review in US

OTL-203

MPS-IH (Hurler Syndrome)

HSC-GTOTL-201

MPS-IIIA (Sanfilippo Syndrome type A)

HSC-GT* PoC studies in the development phase equate to Phase I/II trials, while pivotal studies equate to Phase III trials

Major Applications and Approvals
Code Name (Generic Name, Product Name)

Indication

Application/Under Review

Countries/Regions
Received Approval in 2023

AMG531(romiplostim, Product name in Japan: Romiplate)

Aplastic Anemia Previously Untreated with Immunosuppressive Therapy—

JP

KRN125(pegfilgrastim, Product name in Japan: G-Lasta)

Mobilization of Hematopoietic Stem Cells into Peripheral Blood for
Autologous Blood Stem Cell TransplantationJP—

KHK4827(brodalumab, Product name in Japan and Asia:
Lumicef)

Palmoplantar Pustulosis—

JP

Systemic Sclerosis

JP—

KHK7580(evocalcet, Product name in Japan: Orkedia)

Secondary Hyperparathyroidism

CN
TW

KR

KHK7791(tenapanor hydrochloride, Product name inJapan: Phozevel)

Hyperphosphatemia in Patients on Dialysis

—

JP

20

Kyowa Kirin Co., Ltd.
Integrated Report 2023

CONTENTSINTRODUCTION

AT A GLANCETOPICS FORVALUE CREATIONTOPICS FORVALUE ENHANCEMENTFINANCIAL INFORMATIONCORPORATE INFORMATION

21

R&D Strategy

Message from the CMO

Creating value with an
R&D strategy based on
CSV Management

Takeyoshi Yamashita, Ph.D.
Director of the Board,
Senior Managing Executive Officer andChief Medical Officer (CMO)

Kyowa Kirin’s CSV Management and R&D strategy
Creating Shared Value (CSV) Management is the cornerstone of management at
Kyowa Kirin. The objective of the CSV approach is to simultaneously create social
value and economic value, and to do this, we have to identify social issues thatneed be addressed and provide appropriate solutions for them. This means
accurately recognizing three factors—external opportunities for businessgrowth, internal assets and expertise, and patient needs. The last factor corresponds to what society needs from Kyowa Kirin. By targeting areas where thesethree factors intersect, I believe we can create innovative, highly competitive
and unique value.
We released Story for Vision 2030 with FY12/2023 results to explain how weplan to strategically consolidate the Group’s resources at the intersection ofthese three factors. In Story for Vision 2030, we announced the Group will focus
on three treatment fields – bone & mineral, intractable hematological diseases/
hemato oncology, and rare diseases. These target treatment fields were selectedbased on the intersection of the above three factors, taking into account our
future vision for Kyowa Kirin and the Group’s business base and size. To address
unmet medical needs and provide life-changing value in these fields, we have toactively utilize innovative modalities. This means not only refining and enhancing our existing strengths in biotechnology and antibody technologies, but also

effectively combining them with external opportunities for business growth.
This thinking informed our decision to acquire Orchard Therapeutics plc, a leader
in hematopoietic stem cell gene therapy (HSC-GT), which is discussed in moredetail below.
In this way, we aim to drive value creation in line with the Group’s patient-­
centric approach and R&D strategy, guided by CSV Management, which seeks tomaximize our internal strengths and external opportunities.

2023 in review
In this section, we review the Group’s R&D activities since the publication ofIntegrated Report / Annual Report 2022 through to the publication of this report.
First, regarding our late-stage development pipeline in Japan, we decided to
discontinue development of RTA 402 (target indication: diabetic kidney disease)
and KW-3357 (preeclampsia), which were both in Phase 3 clinical trials in Japan.
The Phase 3 study for RTA 402, the first large-scale trial run solely by the Company, was aimed at developing a drug that improves renal function, preventing
end-stage renal disease that ultimately requires hemodialysis or other treatment
in patients with diabetic kidney disease. The objective with KW-3357 was toreduce risks to mother and child during pregnancy by improving preeclampsia
symptoms. The decision to end development of these drugs due to lack ofpositive results is regrettable, as they were both designed to address importantneeds, both social and medical. Despite these setbacks, we remain committed
to solving social issues through the provision of pharmaceuticals, guided by ourpatient-centric approach. In terms of new initiatives, we acquired exclusive
rights from BridgeBio Pharma, Inc. in February 2024 to develop and commercialize infigratinib for skeletal dysplasia in Japan. This represents another step
toward realizing our Story for Vision 2030, described in more detail below. We
plan to steadily push ahead with development of infigratinib to improve ourposition in bone & mineral, one of our target treatment fields.
We continued to actively develop global products under our Global Development Organization (GDO), a cross-regional organization established 18 months
ago. Rocatinlimab, which we are developing with Amgen Inc. for the treatment of
atopic dermatitis, is making good progress toward regulatory approval, with over
2,400 participants (as of February 8, 2024) signed up to our ROCKET program,which consists of eight Phase 3 clinical studies. To expand the drug’s indications,we plan to initiate clinical trials for asthma and prurigo nodularis before the endof 2024. With KHK4951, we decided to add diabetic macular edema as a new
development target based on the results of Phase 1 trials for neovascular (wet)age-related macular degeneration (nAMD). Phase 2 trials are now underway forboth indications. Additionally, we announced the acquisition of HSC-GT developer Orchard Therapeutics plc in October 2023. The acquisition was completed

in January 2024. As a result, Orchard Therapeutics’ development therapies,­OTL-203 and OTL-201, have been folded into our pipeline.
Meanwhile, we have added three proprietary development drugs to ourearly-stage development pipeline. KK2260 and KK2269 are being developed with
our proprietary REGULGENT™ bispecific antibody technology and are currently inPhase 1 trials, and KK2845 is an antibody-drug conjugate (ADC) that is on track toenter clinical trials in the first half of 2024.
Our current development pipeline differs in some respects from what weenvisioned at the start of the FY2021–2025 Medium Term Business Plan, but wehave built a strong lineup of products with the potential to provide life-changing
value on a global basis. This has helped clarify the direction we want to take torealize our vision of creating and providing life-changing value. Against thisbackdrop, and in light of developments in our business, we updated our businessstrategy with Story for Vision 2030, which was released with FY12/2023 results.
The update sets out a more concrete vision for what kind of company we want tobe and reorganizes our R&D strategy to make that vision a reality.

Kyowa Kirin’s CSV Management and research strategy
Patient needs(society’s needs)

New solutions
for UMNs

Direct partnerships,
proprietary development

Bone & mineraland marketing
Intractable hematological diseases/
Clinical evidence
hemato oncology
HSC-GT
Patient insights
Rare diseases
Advanced antibody
technology
HSC-GT
Orchard
Biotechnology &Therapeutics plc
antibody(before acquisition)technology

External
opportunities forbusiness growth

Application ofscience & technology
in drug discovery

Internal assets
and expertiseKyowa Kirin Co., Ltd.
Integrated Report 2023

CONTENTSINTRODUCTION

Story for Vision 2030
Story for Vision 2030 sets out a number of strategies for creating and delivering
life-changing value. Key to our approach will be combining disease science(identifying patient needs and exploring disease mechanisms to uncover hints forsolutions) with drug discovery technology (using the hints to develop optimal
solutions), and then working with external partners or leveraging external
resources to complement our own strengths and enhance drug discovery competitiveness. During this process of creating new drug candidates with life-­changing value, we will decide whether to develop them independently or withstrategic partners, taking into account the potential for growth in our own business and maximizing product value.
In terms of disease science, our target treatment areas are bone & mineral,
hematological diseases/hemato oncology, and rare diseases. We selected theseareas based on our existing expertise and know-how in the global business andunmet medical needs identified through feedback from various stakeholders suchas patients and healthcare professionals. We also emphasized areas where drug
discovery can be implemented organically with our existing global business. In
these target treatment areas, we will investigate disease conditions and patientneeds and uncover disease causes and mechanisms, using that information to
identify molecular and cellular regulatory mechanisms to create therapeutic
agents. Key to creating life-changing value will be advanced disease regulation.
Developing drug discovery technology to achieve this will be crucial. Further
improving our existing biotechnology and antibody technology will of course beimportant, but at the same time, we will actively tap into resources from outside
the Group to drive drug discovery research using innovative modalities. The
Orchard Therapeutics acquisition, discussed in more detail below, is a good example of this approach. Orchard Therapeutics gives us more options to create
life-changing value with its HSC-GT platform, which has the potential to deliverradical new therapies for serious genetic conditions. This kind of innovative modality can open the way to drug discovery for rare diseases that have previously beendifficult to treat. At the same time, we will continue to strengthen our drug discovery technologies using AI and data science in order to reinforce the infrastructure
supporting our research activities and to accelerate the pace of research.
External partnerships will be integral to our pursuit of the latest science andtechnology. Through open innovation and partnering activities, we will gain
access to strategic information, insights and technologies and step up collaboration to deliver effective results with partners who complement our expertise andresources. We will also continue to use venture capital (VC) and corporate venture
capital (CVC) activities to capture new business opportunities.

AT A GLANCETOPICS FORVALUE CREATIONTOPICS FORVALUE ENHANCEMENTIn R&D projects that have created life-changing value in this way, we will bedirectly involved from development right through to marketing when we want tomaximize the value of our own products. With Crysvita and Poteligeo, all our
employees were firmly invested in the idea of solving social issues together,illustrated by their desire to deliver the value they created and nurtured to patientsthemselves – value that makes patients smile.
However, R&D projects that have the potential to provide life-changing value topatients will be positioned as “strategic partnering assets” if we are unable tocomplete the R&D process and maximize value ourselves. We will then actively
search for the best partner to meet the objectives of the project. One example ofthis approach is benralizumab, a drug that we discovered and licensed out to
AstraZeneca plc. Since then, AstraZeneca has grown benralizumab into a blockbuster drug. This has helped bring the treatment to more patients, as well as
generate significant profits for Kyowa Kirin. Meanwhile, our partnership with
Amgen for rocatinlimab has allowed us to set up multiple large-scale trials, accelerating development. These cases illustrate how strategic partnering can be an
important option for us.
To realize our vision for 2030, we will strive to create and provide Life-changing
value that brings smiles to patients, in line with our Story for Vision 2030.

FINANCIAL INFORMATIONCORPORATE INFORMATION

Acquisition of Orchard Therapeutics
To enhance our ability to create life-changing value, we have to gain access to
new drug discovery technologies and modalities. After 2030, the focus of thehealthcare sector is expected to shift to diseases lacking effective treatments,
personalized medicine, and radical new therapies. Barriers to drug discovery are
becoming much higher. At the same time, targets in the small molecule andmonoclonal antibody-based drug discovery field – an area we have focused
on—are becoming depleted. This means it will become increasingly difficult tostand out in a market of similar products and we will struggle to meet emerging
needs using only this approach. In contrast, there are still many potential drug
targets in rare and genetic diseases. Given these trends, we decided to acquire
Orchard Therapeutics, a leader in hematopoietic stem cell gene therapy (HSC-GT).
We believe the company is a good strategic fit for Kyowa Kirin and offers potential
synergies. The acquisition has given us access to cellular gene therapy modalities
that will allow us to take on new drug discovery challenges. Orchard Therapeutics
also has the expertise to practically apply the modalities, and the therapies andpipeline that embody them. Orchard Therapeutics’ therapies are already on themarket and its development candidates target serious and rare diseases. We
believe we can maximize their value.

Story for Vision 2030
Strategies for creating
and delivering lifechanging value

Disease Science

Focus disease areas: bone & mineral,
intractable hematological diseases/
hemato oncology, and rare diseases

Drug Discovery Technology
Strengthening Innovative Modalities:
Advanced Antibody Technologies,
Hematopoietic stem cell gene therapy

External Collaboration

22

Assets in focus
disease areas

Value
delivery on
our own

Collaborative value
deliveryLife-changing
Value Creation
Strategic
Partnering Assets** Assets outside of the disease areas of focus are designated as strategic partnering assets, and value maximization is achieved throughcollaboration with partners.

Full-­
licensingKyowa Kirin Co., Ltd.
Integrated Report 2023

CONTENTSINTRODUCTION

We plan to help Orchard Therapeutics further develop its vision for HSC-GTbased drug discovery, while also creating innovative new drugs by combining
our drug discovery technologies and know-how with Orchard’s HSC-GT. In
HSC-GT-based drug discovery, Orchard Therapeutics has a proven track record in
single-­gene congenital diseases and an established discovery process. HSC-GTbased research also needs less time in the pre-clinical phase than the traditional
drug discovery process, with trials potentially starting only around three years
after the initiation of research. As a new initiative, we aim to develop advanced
disease regulation therapies that were previously not feasible by adding new
functions to hematopoietic stem cells. This is where our long track record inbiotechnology and antibody technology will be useful.
In this way, the Orchard Therapeutics acquisition gives us new opportunities
and tools for creating and delivering life-changing value, in line with our vision
for 2030. Drug discovery research in particular will be a key area of collaborationand integration, generating synergies that will support the creation of new value.

Reorganization of R&D framework
The R&D Division has led the Group’s R&D activities since 2014, with an emphasis
on seamless activities from research to development and on cooperation andcollaboration. In January 2024, the R&D Division was reorganized into separate
Research and Development divisions. We also previously established a matrix
management structure called One Kyowa Kirin, which has strengthened joint
R&D activities across functions and regions. Under this structure, pipeline development work is now managed in project teams with members from different
regions and functions, reducing the need for a single organization to reinforce
internal collaboration between research and development. This latest reorganization is more specifically aimed at lifting the Group’s competitiveness in R&D by
giving the Research Division and the Development Division greater independence. The goal is to improve specialization and strengthen their capabilities sothat they can better tackle and overcome issues in line with the Group’s strategy.
Based on the Story for Vision 2030, outlined earlier, the Research Division will
work to deepen and enhance its expertise in skeletal and mineral disorders,
blood cancer and blood disorders, and rare diseases, to create disease assets in
the Group’s target treatment fields. The division will also introduce and utilize
new technologies and modalities from outside the Group through open innovation and strategic investments, just as we have done with Orchard Therapeutics.
The Development Division will continue to develop unique drug candidates in
the pipeline with the potential to provide life-changing value. This will mean not
only creating products in areas Kyowa Kirin is focused on, but also actively
working with the best partners to maximize the value of our assets outside ourtarget treatment areas. Under this new structure, research and development

TOPICS FORVALUE CREATION

AT A GLANCETOPICS FORVALUE ENHANCEMENT

functions will continue to work seamlessly together in each target field and ineach development drug, while also independently formulating their own plans
based on strategies specific to the research and development stages. This willallow us to build our strengths in line with the Group’s strategy and execute R&D
that is more responsive.

Developing human capital
We are conducting research and development based on our vision for 2030 and
the Company’s values, aiming to continuously create life-changing value thatmakes people smile.
To achieve this, we need passionate people with a high level of expertise whoare not afraid of change. In 2020, we formulated “Our R&D Spirits” – our vision for
the kind of R&D organization we want to be.
Our R&D Spirits have four elements:
Be the Best in Science
Passion for Innovation
Every Challenge, a Step to SuccessThis is me. This is our team.

FINANCIAL INFORMATIONTo realize our vision for 2030, it is vital that we expand and enhance the Group’s
intellectual capital. This means continuing to drive the development of ourlong-established antibody technologies, but also bringing in diverse new modalities through innovation and collaboration with external partners. Recent examples of this approach include the development of our proprietary Regulgent
bispecific antibody technology and the acquisition of Orchard Therapeutics.
In development as well, we introduced the Planisware project portfolio
management (PPM) system to centrally manage data related to project progress,
resources and risks, supporting the effective use of intellectual capital. Using thefinancial data aggregated by the system and the links and associations identified
between different projects, we can seamlessly gather, integrate and visualize
project knowledge for effective use. We are now using the system to manage
the Group’s portfolio of development projects, supporting an ongoing andintegrated approach to realizing an optimal development strategy.
In this way, Kyowa Kirin is working to continuously create life-changing valuethat makes people smile by leveraging intellectual capital in development
processes and by combining internal and external intellectual capital assets.

Hematopoietic Stem Cell Gene Therapy (HSC-GT)
Therapeutic
gene

Monocyte/
Macrophage
Granulocyte
T cells
B cells

Integration
NK cells
Megakaryocyte

Self-renewal

23

Accumulating and using intellectual capital

To develop human resources who embody this vision, we formulated the
Human Resources Management Policy in R&D. By putting this policy into practice, we will strengthen the Group’s human capital in Japan and overseas.

HSC

CORPORATE INFORMATION

Erythrocyte

HSC-GT allows delivery of gene-modified blood/immune cells to any part of the body
The effects are expected to continue following introduction as the cells multiply within the body.

Kyowa Kirin Co., Ltd.
Integrated Report 2023

CONTENTSINTRODUCTION

AT A GLANCETOPICS FORVALUE CREATIONTOPICS FORVALUE ENHANCEMENTFINANCIAL INFORMATIONCORPORATE INFORMATION

24

Messages from Key People
Bringing hope to morepatients through our
research

Yoshifumi Torii, Ph.D.
Global Research Head

Delivering
life-changing value topatients worldwide

Ernesto Aycardi
Global Development Head

The R&D Division was reorganized into the Research Division and the Development Division on January 1, 2024. This will allow the Research Division to develop
more specialized capabilities and respond more dynamically to the rapidly changing external environment. To continue creating life-changing value, the Research
Division must of course drive its own research, but it also has to bring in new
solutions from outside the Group to better meet the needs of patients. To retain
our dominant competitive advantage in research, our three research sites – inJapan, North America, and now Orchard Therapeutics – will have to work closely
together across borders. We will step up the pace of globalization in researchfunctions to deliver new medicines that satisfy unmet medical needs.
One objective of our Story for Vision 2030 is to strengthen innovative modalities. To achieve this, we will focus on our existing advanced antibody technologies
and also work closely with Orchard Therapeutics. In addition to promoting hematopoietic stem cell gene therapy (HSC-GT), we will draw on our past research into
various modalities such as antibodies, small molecules and nucleic acids andcombine them to form new modalities, creating a pioneering drug discovery
platform. In disease science, we will channel our existing expertise into threetarget treatment areas – skeletal and mineral disorders, blood cancer and blood
disorders, and rare diseases.
KK2260 and KK2269, currently in Phase 1 clinical trials, are based on our proprietary Regulgent bispecific antibody technology. Starting with basic research, many
researchers have worked on this technology over the years, finally perfecting it
after overcoming numerous challenges. As head of the Research Division, I amvery happy to see that products incorporating the technology are now moving
into the clinical trial phase. KK2845, our first antibody-drug conjugate (ADC)
product, is also scheduled to start clinical trials in 2024. Drawing on our experiencein antibody engineering, we will continue to create ADC drugs that combine
safety with potent pharmacological effects.
Through these research activities, we aim to create and deliver innovative valuethat brings hope to many patients, guided by Our R&D Spirits. The entire Research
Division, working closely with the Development Division, is committed to pursuing the continuous creation of more life-changing value that makes people smile,
under the principle of patient-centric medicine.

As we stand on our journey, let us reflect on the remarkable path we’ve traversed
over the past two years since the inception of the Global Development Organization (GDO). Our unwavering commitment to global excellence has propelled us
forward, igniting a beacon of progress that illuminates our way.
Our pursuit of a global strategy has been relentless. From the earliest days, we
envisioned a symphony that harmonizes and embraces diverse perspectives,transcending borders and time zones. Today, that symphony resounds clearly—atestament to our collective efforts. Even programs with regional footprints, nestledin the vibrant landscapes of Japan and the Asia-Pacific region, contribute to ourglobal crescendo.
We extend heartfelt gratitude to our esteemed stakeholders, partners, and collaborators. Your unwavering support has been the wind beneath our wings. Yet, this isbut a prelude. Our aspirations stretch beyond horizons, and we pledge to deepen
our partnerships, forging an unbreakable alliance to sculpt a sustainable future.
Recently, we reimagined our Research and Development Division, birthing the
Research Division and the Development Division. Our commitment to transforming lives remains unyielding. Daily, we breathe life into our purpose, infusing it with
newfound relevance. “Patient-centricity” is our guiding star—a compass that steers
us toward societal impact.

Our internal systems and processes have undergone metamorphosis, adapting
to the ever-changing external landscape. In the crucible of change, we’ve distilled
our focus. Significant progress has been made in clarifying our perspective andstrategy for different therapeutic areas, and we are making meaningful efforts tomake our resources converge with laser precision. We embrace diversity, for it fuels
innovation. Flexibility is our armor, and agility is our sword. With an unwaveringgaze, we advance clinical development, promising life-changing value to patients
across the globe.
And, now, an epochal stride. KK2260 and KK2269, born from the crucible ofour research team’s ingenuity, embarked on their first-in-human odyssey—the­REGULGENT™ technology, honed over years, pulses within their DNA. Soon,
KK2845—an antibody-drug conjugate—will follow suit. Our shoulders bear theweight of responsibility, which we carry with pride.
Colleagues, let this be our anthem—a symphony of purpose echoing acrosscontinents. As we scale new summits, let our legacy be etched in patients’ hearts
worldwide. For every smile we ignite, every life we transform resonates with thesymphony of our shared purpose.
Onward, upward, and ever forward,

Kyowa Kirin Co., Ltd.
Integrated Report 2023

CONTENTSINTRODUCTION

AT A GLANCETOPICS FORVALUE CREATIONTOPICS FORVALUE ENHANCEMENTFINANCIAL INFORMATIONCORPORATE INFORMATION

Strategic Partnering
Crysvita and Poteligeo and acquiring the new modality of hematopoietic stem

Message from the CSO

cell gene therapy (HSC-GT), we have identified bone & mineral, intractable
where Kyowa Kirin can make a full contribution from value creation through tovalue delivery. We have also seen once again that collaboration with partners is

Continuing to create newvalue and fulfill our purpose
amid a rapidly changing
environment

a key strategic option for maximizing product value. The performance ofFasenra, which is already being delivered to patients worldwide, and progresswith the global development of rocatinlimab, which we have positioned as a
future growth driver, underscores the importance of collaboration with­partners for Kyowa Kirin. To continue creating and providing life-changing
value in an uncertain and increasingly turbulent global environment, we will
focus on these two strategic approaches – focusing on target treatment areasand collaborating with partners – while also staying firmly on the path tosustained growth and our vision for 2030.

Yasuo Fujii
Managing Executive Officer,
Chief Strategy Officer (CSO)

Key strategic partnering assets

hematological diseases/hemato oncology, and rare diseases as treatment fields

Strategic partnering is the key to keeping both these approaches working
effectively. For example, in-licensing and M&A to generate growth in target
treatment fields will remain key considerations in our strategic investment

KK4277

KK2269Target disease:
Systemic lupus erythematosus
Cutaneous lupus
erythematosus

Target disease:
Solid tumors

Phase 1 trials

Phase 1 trials

KHK4951 (tivozanib)

KK2260Target diseases:
Neovascular (wet) age-related
macular degeneration
Diabetic macular edema

Target disease:
Solid tumors

Phase 2 trials

Phase 1 trials

decisions. Also, when collaborating with partners, we will have to identify the
optimal business model – joint-value provision or full out-licensing – to ensure
patients see the benefits of our new drug candidates. Our priority will be on

Leveraging strategic partnering opportunities to realize our vision
for 2030

rapidly and reliably delivering our products to more patients identified as

Our unwavering vision is to continuously create life-changing value that makes

and modality technology are the starting points for creating new drug candi-

people smile. I believe the Company is making steady progress towards this vision,

dates in our target treatment areas and in our collaboration with partners.

backed by an even greater commitment from all our employees.

Based on a medium- and long-term horizon, we will actively make strategic

I think the progress we have made so far in realizing our vision for 2030 has
helped us clarify the direction and approach we need to take to continue
delivering growth. Specifically, we have more clearly defined the treatmentareas the Group has to focus on. After establishing global sales structures forbeing able to benefit from the product value. In addition, new disease science

investments in science or technology that leads to new strengths that complement our existing R&D structure.
Together with our existing solid foundations, built up over many years, wewill make effective use of strategic partnering opportunities to realize ourvision for 2030.

Development drug spotlightEye drops with tivozanib as the active ingredient
KHK4951 is an eye drop with tivozanib as the active ingredient.
Tivozanib is a proprietary VEGFR inhibitor, approved in the US
and Europe as Fotivda, an oral treatment for advanced renal
cell carcinoma (RCC). Kyowa Kirin is developing tivozanib as atreatment for neovascular (wet) age-related macular degeneration (nAMD), in which abnormal choroidal neovascularization
damages the macula, a retinal tissue, and for diabetic macularedema (DME), a complication of diabetic retinopathy in which
hyperglycemia damages capillaries in the macula, causing
edema of the macula and vision loss.

25

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ON

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AT A GLANCETOPICS FORVALUE CREATIONTOPICS FORVALUE ENHANCEMENTFINANCIAL INFORMATIONCORPORATE INFORMATION

Exploring knowledge in new technologies and areas

VC fund investments and CVC activities
firm, with offices in Dublin and New York. We also invested in Fund III set up

the Story for Vision 2030. As an R&D-focused company targeting long-termby Fast Track Initiative, a life science-focused VC firm based in Japan. Since

growth, Kyowa Kirin needs to not only “deepen knowledge” in existing areas

then, we have created our own internal CVC functions, leading to our first

and technologies, but also “explore knowledge” by developing new technol-

investment in October 2022 in Cellarity, Inc. a US biotech startup. Founded

ogies and areas that are far removed from proprietary R&D. By actively

by Flagship Pioneering, Cellarity has emerging technologies that are revolu-

tapping into external innovation and striking a good balance between

tionizing existing approaches to drug discovery. Also in 2022, we gained

exploring and deepening knowledge, we can deliver long-term growthaccess to a high-quality venture company called LUCA Science Inc., via an

without exhausting innovation. One way we are doing this is throughintroduction from Fast Track Initiative. LUCA Science owns proprietaryinvestments in VC funds and CVC activities. To create innovative medicines,

technology that enables the isolation of highly functional mitochondria. We

we aim to gain access to cutting-edge therapeutic areas by making strate-

have launched joint research with the company to investigate treatments

gic investments in international VC funds that target advanced medicine, orfor mitochondrial disease. Additionally, we concluded an acquisition agree-

by building relationships as shareholders with venture companies that havement with Orchard Therapeutics plc in October 2023 and completed thethe potential to become future collaborators, giving us a foothold in inno-

deal in January 2024. The acquisition of Orchard Therapeutics gives us avative technologies and areas.

technology platform and therapy pipeline that will allow us to explore new

In June 2020 we made our first VC investment, investing in London-­drug discovery possibilities in the field of hematopoietic stem cell genebased 4BIO Capital’s Ventures II LP Fund. Through 4BIO’s investment team,therapy. Orchard Therapeutics was previously a portfolio company of 4BIO.

Kyowa Kirin has access to cutting-edge therapeutic areas across the UK,
Europe and the US. Additionally, in November 2020, we invested in Fund III

Going forward, we will continue to actively invest in VC and CVC tosupport Kyowa Kirin’s ongoing creation of life-changing value.

Our approach to generating more innovations forlong-term growth
VC fund investment and
CVC activities

Explore knowledge

established by Fountain Healthcare Partners, Ireland’s largest life sciences VC

venture capital (CVC) activities as part of external collaboration set out in

Develop new technologies andnew business areas

Kyowa Kirin invests in venture capital (VC) funds and engages in corporate

Balance between
exploring anddeepeningknowledge

Conventional
R&D activities

Diminishinginnovation

Deepen knowledge
Improve existing technologies andareas of expertise26

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27

Initiatives to Improve Access to Medicines
Issues preventing access to healthcare

Our initiatives to improve access to medicines

take several years for patients to gain access to a medicine in certain countries,

Healthcare has seen incredible progress in recent years. The development of

Kyowa Kirin supplies Crysvita and Poteligeo, two global medicines for theeven after clinical trials are completed and marketing approval has been

new treatments, diagnostic techniques and pharmaceuticals is creating benefits

treatment of rare diseases. As noted above, developing treatments for rareobtained, due to delays with the inclusion of medicines in health insurance

for a growing number of patients with conditions that were previously difficult

diseases is challenging, but our research and development work for these drugs

reimbursement schemes. This time frame varies from region to region, but

to treat.

was backed by a strong commitment to deliver life-changing value that makes

during the period between marketing and health insurance reimbursement

patients smile.

approval, Kyowa Kirin offers an Early Access Program to give patients access to

However, many diseases worldwide still lack effective treatments. To give an
example, there are roughly 7,000 rare diseases globally with very low patient

Crysvita is a therapeutic antibody for the treatment of X-linked hypophospha-

Crysvita and Poteligeo. Also, in countries where we have no plans to gain mar-incidences. However, the total number of people suffering from these conditions

temia (XLH) and tumor-induced osteomalacia (TIO). XLH is a rare disease with an

keting approval, we run the Named Patient Program for Crysvita to provide

is reported to be as high as 350 million. Many diseases are not well known

estimated incidence of 1 in 20,000. Based on dialogue with patients, we identi-

access to patients.

among healthcare professionals, meaning diagnosis also tends to take a long

fied a very strong medical need for the drug, which spurred our development

These programs are implemented in accordance with the regulations of eachtime, and the low number of patients makes it harder to develop treatments.

work. We were also concerned that the limited number of patients with XLH

country to provide early access to patients who really need our medicines. These

would lead to low enrollment in clinical trials, but trials proceeded smoothly,

activities are backed by distribution systems that guarantee quality and health-with the same condition, there are disparities in access to optimal treatments

Additionally, issues with access vary from country to country. Even for patients

partly due to collaboration with patient groups beforehand. Crysvita truly is acare environments that ensure safe use. Many obstacles stand in our way, but wedue to different economic conditions and healthcare systems in the countries

medicine developed in partnership with patients.

are making steady progress. Through these initiatives, we hope to bring more

where they live. In some developed countries, many patients have access toPoteligeo is a treatment for T-cell lymphomas, including adult T-cell leukemia-­

optimal treatments and medicines thanks to well-established healthcare sys-

lymphoma (ATL), mycosis fungoides and Sezary syndrome. There was initialtems, while in other countries, including low- and middle-income countries,

excitement in the late 1990s after the discovery of anti-CD20 antibodies for thepatients have limited access to necessary treatments or medicines.

treatment of B-cell lymphomas, but research into ATL and other T-cell lympho-

smiles to faces worldwide by delivering life-changing medicines to as many
patients as possible as quickly as possible.

mas with low incidence rates subsequently lost ground in the US and Europe.

Kyowa Kirin Group Policy for Access to Medicines

First identified by Japanese researchers, ATL has high incidence rates in certain

As part of our Vision for 2030, we aim to “consistently create and deliverparts of the world, including Japan. Our researchers persevered in the face of­life-­changing value that ultimately makes people smile.” To achieve this, themany challenges, eventually developing Poteligeo, an anti-CCR4 antibody

Kyowa Kirin Group is working on the research, development and provision ofincorporating POTELLIGENT, our groundbreaking antibody production technol-

pharmaceuticals for conditions with high unmet medical needs using a range ofogy that dramatically increases antibody activity. As a result, patients now havedifferent modalities. We have also started to create healthcare solutions beyond

access to more treatment options.

medicines backed by our extensive knowledge and experience in the pharmaceutical industry.

Kyowa Kirin is working to improve access to these medicines, including inlow- and middle-income countries. Medicines typically have to be approved for

In 2022 we formulated and published the Kyowa Kirin Group Policy for Accessuse and for reimbursement under health insurance schemes in each country

to Medicines, recognizing that the barriers to healthcare noted above are criticalbefore being made available to patients. The first step we take is to increase thesocial issues related to health and welfare that should be tackled by Kyowa Kirin

number of countries worldwide where our products are available in order to

as a Japan-based Global Specialty Pharmaceutical (GSP) company. The policy has

help treat more patients. We disclose the number of countries where Crysvita

three approaches – 1) provide pharmaceuticals for unmet medical needs, 2)

and Poteligeo have been launched as a metric showing increasing access.

improve access to medicines, and 3) ensure quality, stable supplies and patient

However, due to factors such as different regulatory regimes in each market,

safety and promote appropriate use. Our mission is to deliver our products to as

launching drugs can take time. This means that even if effective drugs are avail-many patients as possible as quickly as possible through these activities. Below,

able, patients may not be able to gain access because of conditions specific to

we highlight some of the steps we are taking to improve access to medicines.

their country. To address this issue, Kyowa Kirin is working to provide medicines
upon request from physicians after determining eligibility. For example, it can

Kyowa Kirin Group Policy for Access to Medicines –three approaches
Providepharmaceuticals
for unmet
medical needs

Improve access to
medicines

Ensure quality,
stable supplies
and patient safety
and promote
appropriate use

Make people smile –Deliver life-changing
value thatmakes
peoplesmile

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28

Global Strategic Products / Next-generation Drugs in the Development Pipeline
Crysvita

Poteligeo

Crysvita is a recombinant fully human monoclonal IgG1 antibody against the phosphaturic hormone fibroblast
growth factor 23 (FGF23). Developed by Kyowa Kirin, Crysvita is used to treat X-linked hypophosphatemia (XLH)
and tumor-­induced osteomalacia (TIO). XLH is a rare condition that causes hypophosphatemia due to a genetic
mutation that results in excessive production of FGF23, a hormone produced in bone cells. The condition causes
large amounts of phosphorus in the blood to be excreted in the urine and reduces phosphorus absorption in
the intestinal tract. In patients with this condition, bone calcification is disturbed, preventing normal bone formation. In children, this leads to various symptoms such as bone deformity and short stature, while adults with
XLH suffer from walking difficulties due to lower limb deformity, as well as bone and joint pain, muscle weakness
and dental issues, leading to a material decline in patient QOL. The condition is estimated to occur in one in
20,000 people. Conventional treatments are phosphate and/or vitamin D supplements, with patients typicallyhaving to take multiple doses of medication each day. In contrast, Crysvita is injected every two weeks or every
four weeks and increases reabsorption of phosphate in the kidneys in patients with XLH and TIO. Crysvita also
increases production of vitamin D, which improves intestinal absorption of phosphate.
Since launch in 2018, the number of patients treated with Crysvita has increased steadily, with around 6,000
patients receiving the treatment as of December 31, 2023. Crysvita has seen sustained growth in the five years
since launch, with revenue in 2023 reaching ¥152.4 billion, making it Kyowa Kirin’s first product to surpass the¥100 billion mark. We are targeting global revenue of ¥188.8 billion in 2024.

Poteligeo is the world’s first therapeutic antibody to be produced using our proprietary antibody-enhancing­POTELLIGENT platform. Poteligeo binds to cancer cells by targeting a molecule called CC chemokine receptor 4(CCR4) expressed on the cell surface. It demonstrates antitumor effects by eliminating cancer cells throughantibody-­dependent cellular cytotoxicity (ADCC) activity, enhanced by POTELLIGENT technology. Poteligeo iscurrently available in Japan, the US and Europe, and we continue to increase the number of launch markets.
Poteligeo is approved for the treatment of CTCL*. Patients with CTCL often tend to have tumors on the skin.
­However, in the Phase 3 MAVORIC study, Poteligeo showed evidence of particularly high efficacy in CTCL
patients with cancer cells in the blood. Based on clinical evidence gleaned from the study, we are taking steps to
educate and engage physicians and patients in the US and Europe using the message, “Treat the blood. Treat theskin.” In addition to extending these activities to other regions, we plan to further educate patients in the earlystages of the disease about the importance of performing blood tests, thereby identifying more patients who
can benefit from Poteligeo and maximizing its value. Poteligeo generated global revenue of ¥30.3 billion in 2023.
We are targeting revenue of ¥34.4 billion in 2024.

Number of patients treated

188.8

200

700

2023

6,000

12.9

152.4
150

127.1

10.3

8.8

85.5

100

7.2

58.2
3.8

50

0
Japan

32.6
0.1

7.7

25.1

7.7

7.4

2018

Next-generation Drugs in the Development Pipeline
KHK4083/AMG 451 (rocatinlimab)

Revenue(Billions of yen)

2018

* Cutaneous T-cell lymphoma: Characterized by cancerous T-cells initially appearing in the skin2019

North America

105.2

175.9

87.0

57.7

42.4
12.0

2020
EMEA

20.6

2021

31.0
0.3

2022

35.2
1.7

2023

APAC

* Sales from Early Access Program (EAP) not included in revenue
through FY2022, but included from FY2023 as EAP is expected togenerate modest sales in monetary terms

2024(Forecast)

KHK4083/AMG 451 is an anti-OX40 fully human monoclonal antibody under global development with Amgen
Inc. The initial antibody was discovered in a collaboration between Kyowa Kirin US Research and La Jolla Institutefor Immunology.
OX40 is a member of the TNF receptor family and is expressed on activated T cells. OX40 binds to OX40
ligands expressed on antigen-presenting cells such as dendritic cells (cells that present fragments of invading
pathogens to immune cells) and stimulates the proliferation, differentiation and survival of activated T cells, theformation of memory T cells, and increased production of a range of inflammation-related proteins called­cytokines, triggering systemic and localized inflammatory responses. Patients with atopic dermatitis see
increased levels of OX40-expressing T cells in their blood. The activation of T cells by the binding of OX40 to
OX40 ligands is thought to be the reason for deteriorating or chronic symptoms of the condition.
KHK4083/AMG 451 is an antibody drug that uses our fully human antibody production technology and our
proprietary POTELLIGENT platform, which enhances antibody-dependent cellular cytotoxicity (ADCC). KHK4083/
AMG 451 is seen as a viable treatment for atopic dermatitis and asthma because it binds to OX40 and inhibits its
function by directly acting on activated T cells, reducing the number of activated T cells.
In May 2022, we launched the ROCKET program of Phase 3 clinical trials. The program consists of eight different studies, with more than 2,400 registered patients as of the end of February 2024.

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Special Discussion
Human Capital Reinforcement toward Sustainable Growthwith shared passion for innovation.” Now, in the belief that to realize ourvision even in this rapidly changing environment we need a strategic
story set at an even higher resolution, we have announced “Story for
Vision 2030.” However, whether this can be put into practice will dependon each and every employee. From now on, it will be necessary to define
the roles that each individual employee should play based on this story.
Up until now, we have established a basic talent management policy
and promoted people strategies. Human capital is undoubtedly thesource of our Group’s competitiveness. Our people strategies place theutmost importance on bringing out to the maximum extent the potential that exists within each and every one of our employees, taking on
the challenges of change, and continuing to provide life-changing value.
Talent Management Policy

Please refer to “Story for Vision 2030” on P4 for details.

Rumiko Nakata

Shoko Itagaki

Independent Outside Director

Executive Officer,
Chief People Officer (CPO)

A special discussion was conducted between
Outside Director Rumiko Nakata andChief People Officer (CPO) Shoko Itagaki.
Here, they discuss their thoughts and feelings withregard to the Kyowa Kirin Group’s human capitaland talent strategy.
Putting “Story for Vision 2030” into practice is the potential ineach and every diverse individual
Itagaki: We at Kyowa Kirin designated as our vision toward 2030, “Kyowa
Kirin will realize the successful creation and delivery of life-changing
value that ultimately makes people smile, as a Japan-based Global­Specialty Pharmaceutical company built on the diverse team of experts

Nakata: To steadily put into practice this Story for Vision 2030 initiative,
there is a necessity to define a more specific talent portfolio, such as
what skill sets do our talent possess and where and to what extent they
will be needed. To achieve this, the Company will need to plan whether
to train internally or hire externally. There are many talented and highly
experienced people in the Company, so you should reskill those employees to acquire the new skills needed to correspond with the story.
Itagaki: The pace of change in the business environment is increasing,and many tasks in the pharmaceutical industry call for a high level ofexpertise. As it is my belief that, under these circumstances, all employees need to take ownership of their own careers and constantly beaware of updating their expertise and skills, I would like to promote
career development that supports this.

Bringing about innovation through diversity
Nakata: My first impression is that the Kyowa Kirin Group attracts many
talented people from all over the world, with a good mix of new

graduates and mid-career hires, creating a wonderful atmosphere. In
contrast, since there are many employees who are by nature very
­prudent, I feel that they have settled into conservative thinking andbehavior. In the years to come, the pharmaceutical industry will continue
to change at an even more rapid pace, so if such people take theapproach of carefully examining and avoiding each risk one by one, they
will not be able to keep up with the changes. At Pfizer Japan, where I
worked before, risk was tolerated and change deemed inevitable. Even if
their efforts end in failure, I feel I would like those employees to regard
learning from those failures as being beneficial and displaying a moreproactive attitude in taking on the challenges ahead.
Itagaki: I agree that there are many prudent employees, but from now
on I would like to incorporate into our organization “unusual people” whohave values and sensibilities that have never before existed in our Group.
I want this type of talent to act as a catalyst for major innovation. To prevent these “unusual people” from turning into “ordinary people,” I would
like to foster a culture in which those around them can respect their ideas
and support them so that they are able to demonstrate their abilities.
Nakata: I share the belief that innovation and value creation will notarise if all employees have the same way of thinking. It is important todiversify not only in terms of gender and nationality but also in experience and thought. I believe that bringing together diverse employees
and having them work hard toward a common major goal will lead tovalue creation for the Group.
Itagaki: For diverse employees to come together and create value, andto create the in-company environment in which they will do so, I think it
will be important to do two things. First, to strengthen the leadershipthat will connect the various members and activities and, second, create
an organization with a high level of psychological safety, where everyone can freely share their opinions, and we are strengthening these
efforts. To create further value, I would also like to clarify the content ofeach division’s value creation activities and consider those initiatives thatwill encourage those activities.

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overseas employees. The system has gained a certain level of understanding here, and its design is evoking a sense of satisfaction.
Also, with regard to the building of a talent portfolio, the main point is
HR4U, the global common human resources information system that weare currently setting up. By means of HR4U we will integrate the Group’s
overall human resource information, making it possible to share information on what types of human resources are available in which regions. We
have great expectations for HR4U in implementing the human resource
allocations that will be the engine powering Story for Vision 2030.

Building a vision and talent portfolio to secure a robust
talent pool
Nakata: It is especially the case that the more talented a person is, themore they demand meaningful work to which they can dedicate theirlives. For people holding such ambitions, clearly communicating Kyowa
Kirin’s vision and expressly conveying how the Company intends tocontribute to society will gain in importance in future talent strategies.
Itagaki: In terms of communicating our vision, I’m hearing that, as aJapan-based Global Specialty Pharmaceutical company, our vision ofcontinuously creating life-changing value that brings smiles to people
facing illness has been highly rated by students and resonates withthem. I believe that further instilling this vision throughout the Groupwill definitely lead to the reinforcement of our human capital.
Nakata: In addition to communicating Kyowa Kirin’s vision, you mustensure that fair performance evaluations and benefits are in place, otherwise our people will not be here to stay. Given the current shortage oftalent, you will be quite unable to attract talented people.
Itagaki: You’re right. It is exactly with that in mind that we’re putting inplace a global grading system to fairly evaluate our domestic and

Nakata: With regard to personnel system reforms, such as global grading and the global integration of evaluation systems, Kyowa Kirin is very
advanced compared with other companies, and I highly rate the fact
while aligning the systems overseas with those in Japan that you areupgrading your systems year after year. I think it’s good that this has
given you more confidence. You have an excellent system in place, andone that it will be important for management to take the lead in operating properly in the years to come.

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Itagaki: I think global experience is really important. After all, being able
to exchange opinions and share values with various overseas employees
at a junior age has a great impact on the quality of work later. I believethat providing such opportunities to junior employees is an importantrole for HR departments. It is also important for the next generation ofleaders to gain experience in as many departments as possible and forthem to develop an eye for seeing the group as a whole.
Nakata: At a previous company where I used to work, there was a rulethat you had to have gained work experience in multiple departments
to move up to a certain level. Of course, departments want talented
people to stay with them for as long as possible, but because this rule
was strictly enforced, there was almost no unnecessary retention ofmembers, and this gave rise to many leaders who possessed a variety
of experience.
The Kyowa Kirin Group is also actively implementing measures topromote the mobility of our people, and I thus have high expectations
for the future.

To develop leaders who are able to take a bird’s-eye view ofthe entire Group
Itagaki: We are promoting a succession plan to discover and train
next-generation leadership candidates. In particular, I believe that acompany-wide optimization perspective is essential as a quality we lookfor in the next generation of global leaders. As the organizations for eachfunction and region have been established, there is an urgent need todevelop leaders who can organically connect them and see things froman overall optimal perspective.
Nakata: To produce such leaders, I would like to see more interaction
with members from outside their own countries, especially when it
comes to junior leadership candidates. If you increase opportunities toenable them to actively participate in global activities, they will feel lessintimidated at the prospect of leading members globally. I believe that
the Group’s overseas net sales will further increase in the years to come,so it is my hope that a steadily increasing number of next-generation
leaders, who have a global perspective and are able to take a bird’s-eyeview of the entire Group, will be coming through the system.

30

Drive global talent management Formulation of global succession plan
Globaltalent pool
reinforcement Visualization of next-generation leader candidates
and formulation of individual development plans Global Exchange Program OKK Academy Identification of global key positions and theirtalent requirements

Development of HR
foundation Implementation of global grading Formulation of leadership principles Introduction of global human resource system (HRIS) Introduction of new HR system based on positions(Japan/Managers)

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Toward further increasing the ratio of women in management
positionsNakata: The Company has adopted the plan to increase the proportionof women in management positions to 18% by 2025, but my feeling isthat this goal is still too low. New graduate employees are joining thecompany with a 50/50 split between men and women, but this difference in the ratio in managerial positions represents a major problem. I
don’t think it can be improved unless some drastic measures are taken.
As an outside director, I would like to make a strong point here that
advancing diversity will definitely lead to the creation of innovationand improved productivity and will ultimately contribute to shareholder returns.
Itagaki: Thank you for your forthright remarks. I believe that the key toincreasing the proportion of women in management positions is toboldly provide opportunities for women to play active roles. I myself
received major opportunities. There were times when I was worried as I
had to balance childcare, but by working wholeheartedly to somehow
meet those expectations I was able to produce results, and I feel that it
was a great experience that helped me gain the qualities required of aleader. Based on my own experience, I would like to create an environment that provides more opportunities for female employees.

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Nakata: If there are 10 requirements for a leader, men will raise theirhands and say they can become a leader if they just meet two or threeof them. In contrast, it is often said that there are cases in which women,even if they meet five requirements, are turned down as leaders because
they lack the remaining five. Women are cautious, and there are some
aspects, like just giving something a try, that can prove difficult for them.
It’s for that very reason that I think it so important to tell them how
rewarding and interesting something will be, and to encourage andsupport them. To achieve this, female leaders must convey not only theweight of responsibility that comes with their work, but also the joy they
derive from it. If you go up one flight of stairs, the view you see changes
and the amount of information you can obtain increases. Once you areable to have your own opinions heard and exert some influence, yourwork will become that much more interesting.
Itagaki: It’s true that the view you can see when you become a leader isdifferent. When I was in the position at which I could take a bird’s-eyeview of the entire Group, I was able to clearly understand the kind of rolethat the department in which I had previously been had within the
Company and what was expected of me. This feeling cannot be
obtained unless you are a leader, and I think it will have great significance in my working life from now on.

Health and Productivity Management

Creating an organization in which an active and diverse group of people can work toward driving innovation creation
To create life-changing value that brings smiles to the faces of patients around theworld, we believe that we ourselves firstly need to be physically and mentally healthy,
full of vitality, and live every day full of smiles.
The Kyowa Kirin Group engages in Wellness Action so that its employees andthose around them can themselves lead healthy fulfilling lives and contribute to theCompany and society as a whole in a lively manner. The status of each measure ischecked and evaluated both quantitatively and qualitatively at Executive Committee
meetings and other meetings. In recognition of these efforts and achievements, theCompany was included in the Health and Productivity Stock Selection in 2022 and2023, having met the prescribed criteria in the Health and Productivity Management
Survey conducted by the Ministry of Economy, Trade and Industry. The Company was
also recognized as a certified Health and Productivity Management Organization

2024 (White 500), for the eighth consecutive year since the program was launched.
Following on from the previous year, the Japan region focused on the walking
campaign that is held twice a year with the aim of providing opportunities forphysical activity and revitalizing communication through a collabo-health* project
co-organized by the Company’s Health Insurance Association. In the fall 2023
­campaign, 85.7% of employees took part. In each region outside of Japan, we comprehensively considered well-being from both physical and mental aspects, and avariety of initiatives and benefit programs were offered throughout the year to
improve the well-being and care of employees.
* “Collabo-health” refers to collaborative activities organized through coordination between
corporate health insurance associations and companies to enhance the health of employees
and their families.

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31

Nakata: It would be great if you could serve as a role model for female
managers and pass on your feelings and experiences to the next generation of female leadership candidates.
At the Kyowa Kirin Group, the elements necessary for future growth
are being expanded, and the strategies and personnel base to leveragethese elements are also being strengthened. All that remains is for all
employees to firmly understand their own missions and to carry themout. And I’d really love to see this lead to final results. As an outside
director, I would like to do my best to support the Company.
Itagaki: Thank you for that. I believe that Story for Vision 2030, which
we announced in February 2024, is a statement of our intention toclarify our growth story and seriously realize our vision. To accelerate
this story, we need to clarify and create in visual form the talent andcapabilities we need while also focusing on reforming our corporate
culture and promoting KABEGOE (overcoming barriers) as a key behavior.
In my capacity as CPO, I recognize that this will be a major mission forme going forward. We plan to further improve our people strategy inline with the progress of Story for Vision 2030, so we look forward tocontinued guidance from outside directors, including yourself. Thankyou for your inputs today.

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Kyowa Kirin’s Growth Globally

Message from the CIBO

North America: A successful partnership formed to meet patient needs

The life-changing value we want to deliver“The partnership with Ultragenyx was formed in 2013 to hasten clinical studies

The agreement with Ultragenyx was specifically designed with the intention toand ensure our ability to deliver this promising medicine to patients.”

bring CRYSVITA “home” 5 years after its first commercial use. During that time,
KKNA experienced significant growth and added the talent, technology, andFrom the start – thedriving focus has been
meeting patient needs.
That continues to be our northstar and the purpose behind
our business decisions

Abdul Mullick
Managing Executive Officer,
Chief International Business Officer (CIBO)

The collaboration between Kyowa Kirin and Ultragenyx Pharmaceutical Inc.

infrastructure needed to manage a successful rare disease business on our own.

(Ultragenyx) was established in 2013 to accelerate the development and deliv-

With a greater stake in CRYSVITA, our global company is more invested thanery of CRYSVITA, a biologic therapy with breakthrough designation for X-linked

ever before in meeting the interests of XLH and TIO patients around the world.

hypophosphatemia (XLH) and later approved for tumor-induced osteomalacia

We can readily apply and build upon what we’ve learned from our global work

(TIO). Both companies shared a commitment to meeting the needs of patients

to further awareness, diagnosis, and support for people living with XLH and TIO

and recognized the potential of CRYSVITA to do so.

in the U.S. and Canada.

The partnership between Kyowa Kirin and Ultragenyx exemplifies our

The investments we’ve made will also help us as we expand our focus toshared commitment to advancing rare disease therapies and meeting themore rare diseases, where patients have limited or no treatment options. Kyowa

needs of patients in a coordinated and efficient manner. Through this collabo-

Kirin aims to keep advancing research and bring hope to more patients in North

ration, CRYSVITA became widely accessible, providing hope and improved

America, and around the world – thanks to the capabilities we have built.

treatment options to patients living with XLH and TIO in 46 countries andregions*2 in the world.
Over the years, we began to appreciate that the rare disease business brings
companies closer to patients, in every part of the value chain.
Many patients living with XLH and TIO are misdiagnosed for long periods ofTo “become a Global Specialty Pharmaceutical business” wastime; so we collaborate with stakeholders, including patient associations andhighlighted in the 2013–2015 medium-term business plan. At

physicians, to raise awareness and support accelerated patient identificationthat time, investments and select product development activities

and diagnoses. And the journey with our patients keeps going.

began to increase internationally.
The global Kyowa Kirin business has grown since the approval
and launch of its global products: CRYSVITA, POTELIGEO andprompt treatment. Additionally, to navigate the complex reimbursement andaccess pathways in the United States, the company has a team of trained Kyowa

global business grew 141% between 2019–2023 and contributedout their journey.

North America and EMEA has been an engine of growth for thecompany. Behind the growth is the life-changing value we aim
to deliver to our patients. As a result of our continuing efforts,
we continue to help bring smiles to even more patients andtheir families.
*1 The United States and JapanThe transition of commercial
responsibilities took detailed
planning and coordination, but theoutcomes are very positive. Our
teams feel inspired by the patients
we’ve met: we see the real difference that treatment has had in
their lives and we continue tobelieve that we can help more
people living with XLH and TIO.

We strive to educate physicians about the disease and, once a patient

Kirin Cares case managers to offer support and assistance to patients through-Over the last several years, international business especially

Message from management

receives a diagnosis, ensure the patient can receive appropriate care and

NOURIANZ*1 globally. Thanks to these achievements Kyowa Kirin’s
65% of the sales of the company in 2023.

VOICE

Many market factors result in more opportunities to engage with patients in
the US, and this sets the North American business apart. The insights gained
from this model can be reapplied to more programs in the region, helping us
the deliver life-changing value through better education, community support
and access to treatments.
*2 Kyowa Kirin territory.

Richard Wilson
Vice President, North America,
Rare Disease Franchise Head

Kyowa Kirin Co., Ltd.
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Patients Advocacy Story

Our Pledge to XLH & TIO community
opened our eyes to more of the concerns and needs patients confront, often

We are grateful to the individuals and organizations who are joining us

alone or distanced from other patients like them. Common needs identified byin this work. By working together, we believe we can “make people smile.”

patients and the advocacy organizations are supporting faster diagnosis,
improving resources for disease management and care transitions, expanding
multi-disciplinary physician education, and working to eliminate the barriers
patients face to prescribed treatment and care.
To ensure patients understood we would stand beside them, as partners, inaddressing these issues, we issued a Pledge that outlined our company’s commitment to:Please click the link below for details on Our Pledge to
XLH and TIO Patient Communities

Providing a world-class patient support team to be your partner along thejourney
Actively listening to and seeking patient input
In North America, we recognized that the Crysvita transition could raise

Collaborating closely with advocacy groups to best support the community,

concerns for patients who were unfamiliar with our company history. So inand2022, the North America Public Affairs team began investing significant

Acting upon the insights patients share to strengthen resources and education

time getting to know the XLH community and the XLH Network, a patient

efforts.

advocacy organization (PAO) on a mission to “… create resources and acommunity for affected individuals and their families so they can understand and cope with the complications of the disease…”
We met at medical and patient conferences. We delivered presentations
about the journey burosumab took, from Kyowa Kirin labs in Japan to theEvery day, across our business, we are striving towards these goals. Additionally, we’ve been able to start, support and continue projects aimed at creating abrighter future for people with XLH. These have included:
An annual summer camp from the XLH Network for children growing up withpatients we serve around the world. We also offered webinars to get todifferent abilities and special needs.

know patients and answer their questions about the business and our plans

A survey to understand the broader health care needs of XLH patients andfor patient services.

what solutions may help themThrough these engagements and conversations we heard much more
about what life is like living with a rare disease, and XLH in particular. It

Supporting policy coalitions that are working to expand rare disease resources
An annual conference to educate and connect patients and physicians

Summer camp

VOICE

Message from the patient

A recent patient diagnosed with XLH and on treatment raved about
her Kyowa Kirin Cares case manager:“I wanted to send a huge thank you for everything Hannah [my casemanager] has done for me and my family. My treatment has made abig difference – I can even get in the pool and start swimming! Soon
I’ll be back behind the wheel and driving”
NOTE: Real patient story; however, results on treatment may differ. Patients should speak with
their doctor about what’s right for them.

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AT A GLANCETOPICS FORVALUE CREATIONTOPICS FORVALUE ENHANCEMENTEMEA: the movement to build a stronger organization to deliver
life-changing value to patients by partnering with our patients andensuring we are meeting their priorities and needs.

and support the needs of patients on their journeys living with a rare disease2023 was a significant year for Kyowa Kirin International (KKI), as we embarked

our markets has been a relentless focus on prioritizing and simplifying all

on a significant transformation journey to ensure our business could be wholly

aspects of our work to ensure we can deliver on the full potential of the global

focused on meeting the needs of patients in specialty diseases, in line with our

specialty business and are well positioned to support the future pipeline ofglobal ambition. In August 2023, KKI entered into a Joint Venture Collaboration

specialty medicines.

FINANCIAL INFORMATIONCORPORATE INFORMATION

Programs to improve diagnosis of patients, ensure access to the medicines,
have been at the heart of all our activities. Surrounding the activities in each ofwith Grunenthal for 13 brands in the established medicines portfolio; primarily
through cancer pain. This collaboration was designed to ensure the right focus

To build a stronger Kyowa Kirin and contribute the best to
our patientsand investment in the Established Medicines portfolio by a company alreadyOur vision for our global company by 2030 is clear: The Kyowa Kirin Group

operating in the space, while also focusing the core Kyowa Kirin business oncompanies strive to contribute to the health and well-being of people aroundthe global medicines, Crysvita and Poteligeo.

the world by creating new value through the pursuit of advances in life sci-

focused on pain management, including Abstral® and PecFent® for break-ences and technologies.

The ambition of the collaboration and what was behind the decision

The decisions we have made in the past years ensure we are building a

Our Established Medicines were an important part of Kyowa Kirin’s history andcompany ready to face the future; resilient to changes in the external environ-provided the economic foundation in the International region on which wement, such as pandemics, rises in the cost of living, and outbreaks of conflict.

have built our company including the Rare Disease Business Unit, focused on

Making these changes ensures we can adapt to pressures facing the pharma-

the global specialty products. Over time and as the Established Medicines

ceutical industry and enable us to respond to our internal challenges andportfolio has faced increasing pressures from generics entering the market, it

opportunities so that we can continue our focus on patients.

was clear that additional investment and infrastructure would be required to

By now focusing on our strong areas of bone & mineral, intractable hemato-achieve its projected growth, deliver on the needs of patients, and ensure it

logical diseases/hemato oncology, and rare diseases, we are able to drive value

remains a stimulating and dynamic place to work for our employees.

of our products and maximize our reach to patients by building stronger,

By entering into the JVC with Grünenthal, we were able to infuse the EMBU
portfolio with the resources and the commercial infrastructure required to
grow this important suite of medicines and deliver greater life-changing value

closer relationships with our customers and obtaining a deeper understandingof their priorities and needs.
The Kyowa Kirin team as a whole feels incredibly proud of our achieve-to the patients who need them. Grünenthal is an ideal partner because wements and excited by the opportunities ahead with Crysvita and Poteligeo.

share the same ambitions: to meet the needs of patients living with the dis-

We have shown that there is a significant need for our medicines andeases we serve, to bring renewed focus to the established medicines portfolio

demonstrated that they deliver life-changing value to patients who haveand to provide an exciting opportunity for employees.

limited options. We have achieved these goals whilst managing uncertainty

With the divestment of the Established Medicines portfolio to Grünenthal,and embracing a lot of change in the external and internal environment.

Kyowa Kirin International is now able to focus all of its resources on meeting

Despite challenging times, we remain laser-focused on building resilient

the unique needs of people living with CTCL, XLH and TIO and further

teams focused on maximizing the reach of our portfolio and replenishing ourdeepen its role as a significant contributor to the global business. The teamfuture pipeline through R&D and business development opportunities so

has expanded its reach across the countries in which it operates, both bythat we bring new or improved life-changing value to those that need them.

expanding the number of patients treated with its approved medicines andalso reaching new markets through its geographic expansion efforts.

Focus on core areas ofstrength andbuild strong relationships
with stakeholders

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Digital Transformation Strategy
Continuously creating new digital-value by achieving operational excellence and reinforcing our digital transformation infrastructure

Digital Vision 2030

Digital Transformation Strategy

By 2030, as a global specialty pharmaceutical company with originality, Kyowa Kirin aims to discover unmet
medical needs by utilizing data to provide new services and value, including pharmaceutical products.

1
Digital for

Operation

Achieving Operational Excellence

Initiatives for Generative AI Utilization
Having formed an AI task force team at an early stage, in July 2023 Kyowa Kirin completed and deployedprototypes, such as an in-house version of general-purpose GPT and an in-house SOP search GPT. At thesame time, we have implemented in-house training and cross-divisional proof of concept studies and are
currently commencing initiatives that will lead to value creation.

Kyowa Kirin Digital AI Playground – Utilization Rates
Utilization rate

Its functions expanded by means of an agile
approach, as of the end of 2023 our in-house
Initially

FunctionexampleMulti­
lingualPrompttemplate

Imagefunction

Three Pillars of the Digital Strategy

2,000 times a for day-to-day business purposes.

Voicefunction

Commence initiatives that will lead to value creation

1

2

Digital for
Operation

Digital for
Innovation

Achieving Operational
Excellence

Transformation to a circularvalue chain of data

3

Foundation
for Digital
Reinforcing our digitaltransformation infrastructure

We aim to create new solutions
beyond providing pharmaceuticals,
through collaboration with various
stakeholders and through the use ofvarious types of real-world data fromoutside the Company.

Under Digital Vision 2030, with a focus on personnel anddata, we will steadily advance efforts to reinforce digitaltalent and build a platform for data use across divisions
within the Group in order to reinforce the infrastructure
for promoting digital transformation.

Top phase being reached

To support new working styles in the
new normal of today, we will createa secure, connected environmentthat enables employees to work
anytime, anywhere. We will accelerate productivity gains through this
digital shift in our operations.

­general-purpose GPT was being used approximately

After aboutfour months

Drug discovery support

Clinical support

Identification ofpotential patients

Market Analysis

Efforts to improve efficiency in research, development, production, sales, and back office underway
Questionnaires

Business automation

Insight identification

Increased sophistication of
in-house searches

Early efforts to generate AI started
Release of in-houseversion of GPTDigital talentdevelopment

Establishment of guidelines

Task force launched

Involvement ofsenior-level management

Training
Establishment oftechnology trial cycle

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Digital Transformation Strategy

Transforming to a circularInnovation
value chain of data
2

Digital for

Target Exploration for Next Generation Antibody
Technology

Bispecific antibody
technology

An example of target moleculeand disease discovery throughcomprehensive analysis

AI Drug Discovery Technology Platform

Antibody

Nucleic acidSmallmolecule

Regenerative
medicine etc...

for Digital

Reinforcing digital transformation
infrastructure— Support transformation with people anddata platform —Under Digital Vision 2030, with a focus on personnel and data, we will steadily advance efforts to reinforce digital talent and build a platform for data use across divisions within the Group in order to reinforce
the infrastructure for promoting digital transformation.

AI analysis and search forc­ ombinations of two target
molecules and optimal diseases

Extracts information/hypotheses that are
difficult to be noticed
Significantly streamlines the researchfor optimal target diseases

3Foundation

Aiming to accelerate pipeline creation
with our technology x AI drug discovery
The approach will be applied
to more than just antibodies• To discover the correlation between factors related to drug development, such as our own pharmaceutical­products ⇒ target proteins (genes) ⇒ applicable diseases, through this initiative we aim to discover relationships thathumans could not perceive and maximize the Group’s assets by incorporating AI-based network analysis methods.
• This approach consists of: (1) Drug discovery theme selection (diseases, target molecules, etc.) ⇒ (2) Categorizationof related factors (digitization); (3) Correlation analysis between factors; (4) Evaluation of analysis results; and (5) Drugdiscovery theme selection. However, AI can only provide answers in (4) network analysis, and thus researchers using
AI will need to strengthen both their drug discovery research and data science abilities.
• Therefore, our collaboration with InveniAI is not simply on a contractor basis, but rather a collaborative format thatallows for close communication between their AI experts and our researchers.
• We not only have the right to use their AI platform, but also provide On the Job Training and similar ones to masterits use. Through this type of communication, we are aiming to incorporate AI drug discovery functions and knowhow into the KKC Group.

To realize Digital Vision 2030, Kyowa Kirin is focusing on digital talent development among all its employees andspecialized human resources.
All employees are required to receive digital literacy education at a level that will enable them to understanddigital technology and the concept of data utilization as well as to utilize digital tools smoothly. We also provide
content such as Massive Open Online Courses (MOOCs) to help them make progress with their own learning, and thelatest information is shared daily on Digital Park, social media for sharing information that 2,600 employees access.
For our specialized human resources—digital project planners (DPPs) who plan and promote business transformation
through the use of digital technology; data scientists who conduct data analyses to identify business issues and needs
and make data-based decisions; and data stewards who formulate data utilization rules and processes as well as promote
the utilization of data infrastructure—we have three training programs available. Consisting of short-term intensive
training by level and internal and external certification systems linked to practical training, these training programs lead tocareer advancement and business results. A total of 206 people took the training and 79 of them received certification.
DX Specialized Education

Literacy education for all employees

Strengthening practical skills of
DX professional talent

Improving digital literacy of all
employees
Fostering culture and discovery ofsuitable human resources

Digital Project Planners (DPPs)
Plan and promote business
transformation through utilization ofdigital technologies
Data scientists
Ascertain business challenges/needs,
perform data analysis for data-driven
decision-making
Data stewards
Promotion of data utilization rules,
utilization of process formulation data
infrastructure

Mandatory content
Implementation of e-learning (once a year)

DX
Professionals

Strengthening Practical Skills
Focus on linkage
to practiceAll employees

Optional content
Education on each tool (M365, RPA, BI, AI)
DX dojo
Exemption from fee for data processing
engineer examination (three times a year)“Digital park” social media for sharing
information between employees
Introduction of self-learning content(MOOCs, etc.)

Building Momentum
and Discovery
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Quality Assurance
Q-TOWER: Symbol of Quality First

Message from the CCO

Our medicines underpin
patients’ health

Yutaka Osawa
Representative Director of the Board,
Executive Vice President andChief Compliance Officer (CCO)

We aim to consistently provide world-class quality pharmaceuticalproducts and services in compliance with our global quality, safety
and compliance policies.
To continue to provide reliable quality pharmaceutical­products in today’s complex and dynamic risk landscapes, it isimportant to focus on corrective and preventive actions, withcompliance and risk management at the core of our efforts. We

The new quality building is fully compliant with Japan, the United States, andEuropean Good Manufacturing Practices (GMP). The Q-TOWER was newly constructed to carry out quality operations relating to quality control and quality
assurance, such as the testing of biopharmaceuticals and raw material quality
analysis. This new quality building is equipped with the most advanced biopharmaceutical analysis equipment, including an automated colony counter, rapid
microbial testing, and robot technology. We aim to realize reliable DI (data integrity) by equipping the facility with automated and labor-saving equipment, suchas a liquid handling system and an automated sample picking system, andsterility testing isolator is installed to minimize the number of false positive results
during microbial tests. Also, helping create a laboratory that satisfies the latest
global regulations. By introducing a test facility design that complies with thelatest regulations, flexible space design has been made possible in both thelaboratory area and the office area. For example, an additional laboratory for
robots has been introduced in the office area. In this laboratory, the use of tracked
AGVs (automatic guided vehicles) and collaborative robots under GMP control isbeing actively studied. We are also working to improve the efficiency of quality-­
related operations in conjunction
with promotion of digital transformation through paperless systems
and systemization. By having
designed workspace areas withspatial continuity, we are providing
an environment in which everyone
can work healthily, creatively, andtruly have an optimal workplace for
Utilizing automated systems for viable count testing
fostering a positive culture.

strive to contribute to the health and wealth of people aroundthe world by fostering a healthy quality culture so that we can act
from the patient’s perspective.
We believe that ensuring the stable supply of high-quality
pharmaceuticals is vital for a pharmaceutical company. Having
the highest level of quality and a stable supply of products arevery important management imperatives, therefore, Kyowa Kirin
is advancing various initiatives toward these priorities.

Building a world-class Quality Assurance (QA) system
Pharmaceuticals are products that directly affect human lives. At a pharmaceutical company, quality is the responsibility of every employee. Without robust
quality and compliance, we cannot earn the trust of patients, healthcare professionals, national regulatory authorities or that of society. Kyowa Kirin’s Global QA
Function confirms that various processes, including manufacturing and distribution, are conducted properly and in compliance with relevant laws and regulations. Our overall aim within the Global QA function is to always ensure thehighest quality medicines are delivered to our patients that are in need.
Since 2019, when globalization began in earnest, we have been formulating
the Kyowa Kirin Group Quality Policy and the Global Quality Roadmap to 2025

while steadily strengthening our global QA system. Under this roadmap anenterprise/electronic quality management system (eQMS) that we completed
introduction in 2022 is running smoothly now. Our platform is working well tomeet globally consistent standards as well as the requirements of relevant laws
and regulations for each country and market we serve, by having introduced thissystem, which covers a wide range of quality assurance operations from deviation control, corrective action/preventive action (CAPA), training, document
management, auditing, supplier management, and change management bymeans of a complete electronic process.
Aiming to build a preventive quality management system using risk-based
approaches that we can confidently claim to be world-class, we have set globally
integrated KPIs. While monitoring operational status in real time, we gather andanalyze vast amounts of data collected as well as engage in continuous improvement of processes and the fostering of a quality culture routinely.

Kyowa Kirin Group Quality Policy
The Kyowa Kirin Group will contribute to the health and well-being ofpeople around the world by consistently providing world-class quality
pharmaceutical products and services in compliance with our global
quality, safety and compliance policies.
Compliance and Continuous Improvement
We conduct our business in compliance with all global laws, regulations,and guidelines related to GxP. To ensure compliance, we will continuously
improve our quality management system.
Cooperation and Collaboration with Stakeholders
We maintain sound relationships with regulatory authorities, suppliers,
and contractors around the world to ensure a continuous supply ofhigh-quality pharmaceutical products.
Predictive and Preventive Quality Assurance
We strive to prevent problems before they occur by using information anddigital technologies to proactively identify and address risks.
Fostering a Quality Culture
We foster a healthy Quality Culture in our organization, openly discussing
issues, and collaborating with our teams to ensure that we always act withintegrity from the patient’s perspective.

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Stable Supply
Capital investment aimed at stable supply

Message from the CSCO

Communicating with patientsas a member of the team tomake things happen

Toshiyuki Kurata
Executive Officer,
Chief Supply Chain Officer (CSCO)

We believe that developing new technologies to create
life-changing value, promoting the development of pharmaceutical products, and ensuring the stable supply of high-quality
pharmaceuticals are vital for a pharmaceutical company. We
believe it is extremely important for each employee to have asense of responsibility for continuing to create smiles forpatients, bearing in mind that even if it is just one of 100,000
doses of medicine for us, for the patient, that one dose is everything. We will continue to supply pharmaceuticals of reliable
quality by taking steps to ensure a stable supply globally, pursuing stable production at our plants, and further strengthening
cooperation with contract manufacturers in Japan and overseas.
In addition, we will continue to digitalize and improve the efficiency of manufacturing, develop our human resources morethan ever before in order to create new value, innovate technologies that give us a competitive advantage, and continue toimprove the work-life balance of our employees.

Kyowa Kirin has two key production bases, in Takasaki City, Gunma Prefecture, andUbe City, Yamaguchi Prefecture. Primarily a base for biopharmaceuticals, Takasaki
area is home to the Bio Process Research and Development Laboratories, whichdevelop production technologies and handle regulatory filings, and Takasaki Plant,
which manufactures and formulates bulk pharmaceuticals for investigational
drugs and marketed products. Taking advantage of their geographical proximity,
our teams work closely together. Such collaboration makes this location a worldclass biopharmaceutical research and manufacturing base. Ube Plant is an automated plant specialized in oral solid dosage formulations utilizing a variety ofengineering technologies. We produce and supply pharmaceutical products ofreliable quality with a high degree of efficiency based on the latest manufacturing
technologies and checking systems.
Construction of a new active pharmaceutical ingredient (API) manufacturingbuilding “HB7” in Takasaki Plant is underway and is scheduled to be completed in
March 2025. Manufacturing APIs for biopharmaceuticals utilizing Kyowa Kirin’s
unique antibody technology and protein engineering, the new HB7 Building
will be equipped with both a GMP facility to manufacture APIs for use in
GMP-compliant clinical trials and a pilot facility for the scaled-up verification of
manufacturing methods established in our laboratories. As both facilities havebeen designed to have the same single-use manufacturing equipment, and thesame facility configuration can be used for everything, from the initial processdevelopment of biopharmaceutical API manufacturing to the manufacturing ofinvestigational APIs, it will be possible to manufacture high-mix, small-lot
products in early phase development more flexibly and quickly. Moreover, it isplanned to use the pilot facility to verify the continuous production system,
which is new technology for biopharmaceutical APIs, as part of efforts topromote technological innovation directed at stable supply.
The new warehouse building is also being constructed to accommodate theexpanding supply of biopharmaceuticals (products and development) in Takasaki
Plant. The regulatory authorities in various countries require that strict control
measures be in place for the storage of pharmaceutical raw materials, drug substances, and formulations. For that reason, the new warehouse building will comply
with the standards required by each regulatory authority and be capable of stably
storing biopharmaceutical raw materials, drug substances, and formulations atroom, cold or frozen temperatures. The building will also have a seismic isolation
structure that will enable continuous product supply and the early resumption of
production even in the event of a major disaster, such as an earthquake or flood. It
is assumed that key facilities will be designed to protect them from any damage
caused by flooding. In addition, the facility’s environmental friendliness is being
taken into consideration by installing a solar power generation system on therooftop and actively adopting energy-efficient air conditioning equipment.
Kyowa Kirin completed the construction of a new office building (named “SF
Building” after the skip floor) at Ube Plant in April 2023. SF Building includes anoffice area, conference rooms, visitor’s areas, and a cafeteria. The building features
skip floors and an atrium that foster a sense of unity in the office space, promoting smooth communication among employees and departments. The building
also incorporated an environment-friendly design with energy-saving systems

including solar panels and natural ventilation systems. We are committed tosupply high-quality pharmaceuticals stably while giving due consideration to theenvironment and the local communities.

New biopharmaceutical API manufacturing building, “HB7”(Scheduled to be completed in March 2025)

Supply Chain Management (SCM) and other initiatives
The number of countries in which global strategic products such as Crysvita aresold is steadily increasing, and the overseas revenue ratio, which was 48% in
2020, is expected to reach 70% in 2024. In accordance with this expansion, thesupply chain related to manufacturing and distribution, including outsourcing, isbecoming more and more complex, and Kyowa Kirin is focusing on its management and resilience.
Kyowa Kirin’s SCM Function is responsible for accurately monitoring and controlling this complex situation so that our pharmaceutical products reach thepatients who need them, when they need them, and in precisely the quantity
needed. To control the supply-demand balance with a high degree of precision,
the SCM Function serves as a coordinator, building strong partnerships internallyin particular with the quality assurance, production, and sales functions as well as
externally with contract manufacturing companies and logistics companies. At thesame time, by further evolving S&OP* initiatives, the SCM Function helps to optimize inventory levels while supporting rapid decision-making by management.
Transportation risks arose in 2022 due to the Russia-Ukraine conflict, but
Kyowa Kirin has continued to maintain stable supplies through SCM Functioncentered cooperation and response. For the Company to keep this up going
forward, in addition to early anomaly detection and continuous improvement
through supply chain KPI monitoring, we are planning a raft of measuresdesigned to maintain a stable supply. These measures include building andupdating stable supply Business Continuity Plans (BCPs) and the dispersing of
our storage locations for APIs over multiple sites. We will also further expand
measures to counter the problem of counterfeit drugs, which has become
increasingly serious in recent years, and contribute to the creation of an environment in which patients can receive treatment with peace of mind.
* Abbreviation for Sales and Operations Planning. A system that enables sales and production/
operational divisions to confirm plans and results, both in quantitative and monetary terms.
S&OP ensures alignment on the optimal plan for the Company, increasing the accuracy andspeed of decision making to support the achievement of the Company’s financial targets

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Retain the trust of society

Ensure a Thriving Global Environment for Future Generations
We are actively working to conserve the environment for future generations. As part of this commitment, we aim to decarbonize our company, including the value chain.
Environmental Management
Having incorporated priority environmental issues from the perspective of theirimpact on the sustainability of society and on the Group’s business in its FY2021–
2025 Medium Term Business Plan, Kyowa Kirin is setting targets for each fiscal year
and implementing measures accordingly. In particular, we have positioned climatechange mitigation and adaptation and water resource management as coreenvironmental issues. As well as our annual targets, we have set medium- andlong-term targets, developing a range of measures to achieve these.
We have established and are operating a governance structure for Kyowa Kirin’s
environmental management. The Executive Vice President has been appointed as
its chief executive officer. (For details, see ‘Responding to the Task Force on
Climate-­related Financial Disclosure (TCFD)—Governance (relating to environmental issues)’ on page 41.)
In our daily environmental management activities, we operate all of our domestic plants and research laboratories in accordance with the ISO 14001 environmental management system.

Addressing climate change
The Kirin Group, of which Kyowa Kirin is a member, has formulated the Kirin Group
Environmental Vision 2050. In its vision, the Kirin Group has set a goal of achieving
net-zero greenhouse gas emissions in its entire value chain by 2050 as a “Societythat has overcome climate change,” a society in 2050 that we want to create
together regarding climate change.

Ratio of emissions by energy type and CO2 emission reduction
effect from introducing renewable energy, etc. (all plants andresearch laboratories in Japan and overseas)
Natural gas
1%
Steam
1%
Kerosene
6%

Approx. 55%
reduction

Other
1%

In order to realize a society that has overcome climate change, as with the Kirin
Group, Kyowa Kirin has raised the target of achieving net zero greenhouse gas
emissions throughout the value chain by 2050. Moreover, Kyowa Kirin has adopted
several more specific medium- and long-term targets, including fully converting
power consumed by the Group to renewable energy by 2040 and reducing CO2
emissions in 2030 by 55% from the 2019 level. As specific commitments related toclimate change, we have raised the charges of “Promoting early reduction of CO2
emissions” through “Energy conservation” and “Expansion of renewable energy”
including capital investment, and “Promoting energy conversion.” In this respect,
we have created a road map for achieving the 2030 target, and set forth a shortterm target (FY2024 CO2 emissions: 51% reduction compared with 2019). We will
also utilize the Kirin Group as a network in an effort to contribute to the realizationof this vision by actively developing climate change measures that leverage ourbusiness characteristics.
To promote the use of renewable energy, Kyowa Kirin has been promoting the
introduction of solar power generation equipment at our major business locationsin Japan since 2011. As of the end of FY2023, such equipment is in operation at
Tokyo Research Park, Fuji Site and Takasaki Plant. In March 2023, we also began
operating a large-scale solar power generation facility (1.47 MW) at Ube Plant
using an on-site power purchase agreement (PPA) model. Moreover, we also
operate solar power generation facilities at Kyowa Kirin China Pharmaceutical Co.,
Ltd. (Shanghai), and at Kyowa Kirin USA Holdings, Inc./Kyowa Kirin, Inc. (North
America). In the meantime, we have been gradually introducing RE100-compliant

Large-scale PPA model solar power generation facility
at Ube Plant

renewable energy at Takasaki Plant, Fuji Site, and Ube Plant since 2020, switching
100% of the electricity consumed at each plant to renewable energy. By introducing these renewable energy projects, of the approximately 78,000,000 kWh ofannual power consumed by the Kyowa Kirin Group in FY2023, approximately
65,400,000 kWh were switched to renewable energy with zero CO2 emissions.
When combined with the reduction effects of our energy-saving initiatives, theGroup’s annual CO2 emissions declined by approximately 55% (28,300 t).*1 In 2021,
RE100-compliant renewable energy was also introduced for the electricity of thehead office.*2
Going forward, the plan is for us to have switched energy consumption to 100%
renewable energy at our major business locations in Japan by 2025, and energy
consumption at all of our group business locations, including overseas sites anddomestic branch and sales offices, by 2030. In addition, we will continue to expand
the introduction of solar power generation facilities at our domestic and overseas
plants and research laboratories, among other facilities.
Each plant and research laboratory*3 sets its own energy intensity reduction
targets for a single year, implementing measures to improve production efficiency.
Unit energy consumption in FY2023 was 6.4% lower than the previous year.
Also working to reduce CO2 emissions from our sales vehicles, since 2009 we havebeen promoting the introduction of hybrid cars for our sales vehicles (company cars)in Japan. Since FY2019, all newly introduced sales vehicles have been hybrid cars. As
a result, by the end of FY2023 we had completed the introduction of hybrid cars forall sales vehicles used in Japan (achieved a hybrid car adoption rate of 100%).

CO2 emissions from sales vehicles and hybrid car adoption rate
(t-CO2)(%)

4,000
3,000

City gas
26%

91.7

99.2

100.0
100
75

2,355

2,000

Electricity
66%

96.9

92.9

1,524

1,913

1,790

1,725

1,000
2019

2023 results

Starting in 2020, we have converted
electricity consumed at, in order,
Takasaki Plant, Fuji Site, and Ube Plant, etc.,
to RE100-compliant renewable energy.

0

50
25

2019

2020

CO2 emissions (left scale)

2021

2022

2023

Hybrid car adoption rate (right scale)0Kyowa Kirin Co., Ltd.
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Retain the trust of society

Water resources management
Kyowa Kirin conducts water risk assessments (such as water shortage/water stress,
flooding, and water pollution of water sources risk assessments by WRI Aqueduct
and WWF Water Risk Filter) at each plant in Japan and overseas.
As a result of the assessments, we identified that Ube Plant has a higher risk offlooding due to droughts and storm surges and that at Kyowa Kirin China Pharmaceutical Co., Ltd. (Shanghai) the risks of water shortages and flooding were greaterthan at other plants. In the latest local flooding simulation published by the
Ministry of Land, Infrastructure, Transport and Tourism, it is assumed that Takasaki
Plant would suffer flood damage.
In response to these results, alongside soft measures such as reviewing or
formulating plant BCPs for large-scale natural disasters, we are also implementing
hard measures such as flood prevention measures at facilities to avoid or minimize
these risks.
Under the Kirin Group Environmental Vision 2050, Kyowa Kirin is working toconserve water and protect water resources in accordance with the Kyowa Kirin
Group Environmental Policy. We set our 2030 water withdrawal reduction target toa 40% reduction from 2019 levels, and have also set short-term targets to achieve
the 2030 target. As of the end of FY2023, we have achieved a 36% reduction fromthe 2019 level*1 against our 2030 water withdrawal reduction target. Furthermore,
to improve the efficiency of water use, each year we set and manage water consumption intensity targets for each plant and research laboratory. In 2023, ourwater consumption intensity was 9.0% lower*3 than the previous year.

Biodiversity
At Kyowa Kirin, we are using our procurement activities to help protect the world’s
forests. Specifically, we have adopted FSC®-certified products*4 for materials suchas company envelopes, company brochures, and cardboard product packaging.

TOPIC

In accordance with the Kirin Group Action Plan for Sustainable Use of Biological
Resources, which was revised in 2021, we continue to study applications for
FSC®-certified products. In addition to expanding their use for domestic productpackaging cardboard boxes, we are considering using them for materials such as
product inner boxes. We are also considering the use of FSC®-certified products foroverseas business sites and products.
As part of its activities to preserve ecosystems and ensure biodiversity, Kyowa
Kirin has been working to protect water resources through its engagement in the
Kirin Group’s water-source preservation project since FY2007. Takasaki and Ube
Plants carry out weeding, planting and tree thinning to create forest areas thatprovide water resources. In addition, for the eighth year running*5, Kirin Holdings
Company, Limited has been recognized as the highest Water Security A List
company by CDP, an international non-profit organization that provides an environmental data disclosure system. CDP praised the Kirin Group, of which Kyowa
Kirin is a member, for its efforts in protecting water resources, evaluating river
basin water risks at manufacturing sites, and for formulating and implementing
strategies that reflect those risks.
Kyowa Kirin business sites also work with various local communities to preserve
ecosystems, including releasing young amago trout into rivers, or protecting
grasslands of Akiyoshidai in Yamaguchi Prefecture. Fuji Site continues to participate
in collaborative activities with local government, such as Shizuoka Prefecture’s River
Friendship Program, which organizes cleanups of local rivers, and a campaign toclean up trash from areas around Mount Fuji. Through these activities, we willcontinue to support local communities and raise awareness of the importance ofpreserving the beauty of the natural environment and protecting biodiversity.
In our research, development, and manufacturing of pharmaceutical products,
we have established an in-house committee to ensure compliance with the Act
on the Conservation and Sustainable Use of Biological Diversity throughRegulations on the Use of Living Modified Organisms (“the Cartagena Act”) and to
conduct appropriate management.
The Kirin Group is advancing a range of initiatives in this area, including theKirin Group Declaration of Support for Biodiversity Conservation, formulated in
2010, and the Kirin Group’s Guidelines on Sustainable Sourcing of Biological
Resources, formulated in 2013.

Other environmental impact reduction related topics
Ube Plant’s new office building, which was completed in April 2023, received ZEB(net Zero Energy Building) certification*6 as a first for both the Kyowa Kirin Groupand the Kirin Group. Moreover, construction of Q-TOWER, a new quality assurance-­
related complex facility completed in December 2022 at Takasaki Plant, adopted
the precast-prestressed concrete (PCaPC) construction method*7. In addition to
improving productivity as a result of shorter construction times and ensuring safety
and high quality, this approach also helped mitigate environmental impact bycurtailing noise levels around the construction site, reducing waste as a result of
fewer secondary materials, and realizing resource- and material-savings.
*1 Calculated based on FY2019 data for Kyowa Kirin Group’s plants and research laboratories in Japanand overseas.
*2 Otemachi Financial City Grand Cube, where Kyowa Kirin’s head office is located, has adopted
RE100-compliant electricity derived from renewable energy sources.
*3 Kyowa Kirin Group plants and research laboratories in Japan and plants overseas.
*4 Kyowa Kirin has obtained an FSC® promotion license (FSC® N003037).
*5 From the most recent assessment results (FY2023 assessment) as of February 29, 2024.
*6 A certification granted to buildings designed to achieve a net zero energy balance by reducing
primary energy consumption through energy-saving measures and by introducing renewableenergy, etc., while realizing a comfortable indoor environment.
*7 A construction method in which concrete members are manufactured in advance at a construction materials plant, etc., and assembled on site.

— Working together as one Group to protect the environment —Adoption of FSC®-certified paper

Forestry activities topreserve water resources

New ZEB certified office building(Ube Plant)

Q-TOWER constructed using the PCaPC construction method (Takasaki Plant)

Exterior

Laboratory

Office area

Kyowa Kirin Co., Ltd.
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Retain the trust of society

Responding to the Task Force on Climate-related
Financial Disclosures (TCFD)

and advancing measures accordingly.
As mitigation measures, to support the achievement of net-zero greenhousegas emissions throughout the value chain by 2050, we have set our 2030 CO2
reduction target to a level corresponding to the Science-Based Target (SBT) 1.5°C
target,* prepared a roadmap for achieving this target, and set short-term targets.
Having incorporated targets (CO2 emission reduction achievement rate, renewableenergy introduction rate, 1% reduction in energy intensity compared with theprevious year, etc.) for each fiscal year in the FY2021–2025 Medium Term Business
Plan, we are promoting measures, such as the early introduction and expansion ofrenewable energy, energy conservation, and energy conversion, and responding
to the risks associated with the transition to a decarbonized society.
As an adaptive measure, we will formulate a Business Continuity Plan (BCP) forlarge-scale natural disasters. This will address the impact on global production
activities arising from flooding of plant and research laboratory premises. We
respond to physical risks by implementing flooding prevention measures andcapital investment as required. Going forward, we will continue to minimize risk byassessing and addressing the impact throughout our supply chain.
On the other hand, an increase in the number of hay fever sufferers had led to
expectations of an opportunity for the allergy drug market. However, we believe
the actual impact on sales revenue will be limited. Recognizing that this will form
an important point in future business strategies, we will continue to consider new
developments in this field to meet medical needs based on our management
philosophy.

Since announcing our endorsement of the TCFD recommendations in 2021,
Kyowa Kirin has identified the risks and opportunities that climate change poses toour business, as well as the impacts of these risks and opportunities. We haveorganized our findings into four areas: governance, strategy, risk/opportunity
management, and indicators and targets in line with TCFD recommendations.

Governance (relating to environmental issues)
Issues related to risks and opportunities in climate change, as well as environmental activity policies and results are positioned as important matters in the Group’s
environmental management. These issues are reported, deliberated upon, anddecided by the CSR Committee, which is chaired by the Representative Directorand Executive Vice President, who has the highest responsibility for overall environmental management. The content of these discussions is reported to the Boardof Directors. In addition, from FY2020 we put in place a TCFD Study Team within
the CSR Management Department, which is responsible for the environmental
management control function. This team studies the identification and evaluationof climate change-related risks and opportunities and our response to them. We
are addressing climate-related issues as part of management strategy by regularly
reviewing the risks and opportunities that have been identified and reportingthem to and having them brought up by the CSR Committee.

Strategy* Science-based corporate greenhouse gas emissions reduction targets consistent with theParis Agreement levels

We aim to achieve a world in which the average temperature increase is limited to
1.5°C or less, as outlined in the Paris Agreement. We are reviewing our climatechange response based on the results of our scenario analysis of climate change-­
related risks and opportunities and also in the context of the Kirin Group Environmental Vision 2050. We are incorporating these findings into our business strategy

Risk/opportunity management
To identify risks and opportunities, we comprehensively assess—based on scenario analysis for each risk and opportunity—the expected timing and probability

Analysis of risks, opportunities and financial impact related to climate change
Pink: Risk Blue: Opportunity
Scenario classification

Climate change-related drivers with
impact assessment

Transition risk
Physical risk

Carbon pricing (decarbonization,
emissions trading schemes)
Policy and regulations
Tighter CO2 emission regulations
Population/economy/
Population growth in emerging
geopolitics­economies/economic globalization
Community
Changing social values
Extreme temperature rises
Increase in averagetemperature and change Increased torrential rains, typhoons,in rainfall pattern (acute) and floods
Changes in hay fever patients
Increase in averagetemperature, changes in Increased energy consumption due
rainfall pattern (chronic) to increased air conditioning loadPotential impact

Change throughresponse(resilience)

Small

±0

Slight

Small

±0

±0

Slight
Small

±0
Small

Large

SlightMediumMedium

Small

Small

Achieve 2030 target
early and reduce
CO2 emissionsof occurrence, the scope and magnitude of impact, and the nature of countermeasures. We manage these risks and opportunities by identifying those that havea significant impact on business, that involve a high degree of social responsibility,or have a high probability of occurrence. We monitor and manage, on a quarterly
basis, our measures to address the risks we have identified.

Metrics and targets
In 2021, we set a new 2030 CO2 emissions reduction target of 55% reduction from2019 levels. This is based on the SBT 1.5°C target. In addition to creating a roadmap
for achieving these new targets, we have set short-term targets (2024 CO2 emissions: 51% reduction compared with 2019). Incorporated into our FY2021–2025
Medium Term Business Plan, we are setting and managing annual targets for eachfiscal year, while studying and developing measures to achieve them.
In addition, the Kirin Group has set a goal, based on the Kirin Group Environmental Vision 2050, of achieving net-zero greenhouse gas emissions for the entire
value chain by 2050. As medium-term targets, the Group has upwardly revised its
greenhouse gas reduction target to a 50% reduction in Scope 1 + Scope 2 and a
30% reduction in Scope 3 by 2030 compared to 2019 (approved for the SBT 1.5°C
target). A target of 100% renewable energy sources for electricity consumption
has been set for 2040 (RE100 member). As with the Kirin Group, the Kyowa Kirin
Group has raised the goal of achieving net zero greenhouse gas emissions
throughout the value chain by 2050. As a more specific medium- and long-termtarget, we aim to adopt renewable energy for all energy consumed by 2040, andare working with the Kirin Group to achieve this goal.
The greenhouse gas emissions in the Kyowa Kirin Group’s value chain (Scope 3)
are calculated by dividing them into 15 categories in accordance with the Ministryof the Environment’s guidelines, which are consistent with the GHG Protocol. To
achieve the Kirin Group’s goal of net-zero greenhouse gas emissions for the entire
value chain by 2050, we will continue to work on reducing Scope 3 emissions.

Installation of tidal embankment(artist’s impression, Ube Plant)

Baseplate
Embankment
block

Tidal
breakwater

Review workplace
BCPs for major
natural disasters
Disaster preparedness of facilities

Steel pipe
pilings

Kyowa Kirin Co., Ltd.
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Human Rights
Basic Policy and Internal System

Kyowa Kirin Group Human Rights Policy

https://www.kyowakirin.com/sustainability/human_rights_labor_
practices/human_rights/index.html

Human rights due diligence
In the presence of CRT, in 2022 we held a human rights due diligence workshop,
during which we identified human rights themes faced by Kyowa Kirin. As a resultof this workshop and an assessment made through a desktop study, we identified
the priority issues that must be addressed by the working team. Similarly, in 2023,
we conducted a survey of foreign technical intern trainees at a supplier used by
Takasaki Plant. Together with CRT, we directly interviewed the management
department and technical intern trainees at SHIN-NIPPON WEX CO., LTD.,* which
actually employs the technical intern trainees. These interviews confirmed that
SHIN-NIPPON WEX respects the human rights of its technical intern trainees, anddoes not present any specific issues of concern regarding human rights violations
at the current time. Although it is difficult to assess the entire value chain, which
includes the supply chain, we will continue to conduct a cycle in which we survey
and evaluate human rights issues that have emerged or present a high potential

Realizing responsible procurement

risk of doing so, engage in the requisite initiatives, advance to the next step basedon the results of these efforts, and disclose the outcomes.

Growing social pressure in recent years regarding human rights and the environment has led to the demand to manage entire supply chains, including suppliers.
International standards regarding supplier management have also emerged, as
represented by the PSCI* Principles for Responsible Supply Chain Management(hereafter, PSCI Principles). Because our business extends across the globe, wehave also advanced efforts within the Group to establish a Supplier Code of
Conduct for each region. Triggered by these changes in the environment, however, in 2023 we revised the content of these codes to create a unified global
Supplier Code of Conduct. Through this revised Group Supplier Code of Conduct,
we will practice supplier management in a manner that better addresses thedemands of society, and aim to contribute to stable supply by promoting sustainable procurement in a way that links with the supply chain.

* The link for SHIN-NIPPON WEX CO., LTD. is included below.

https://www.wex.co.jp/english/

Constructing a correction and complaint handling mechanism
In cooperation with Kirin Holdings, we are standing members of the Japan Center
for Engagement and Remedy on Business and Human Rights (JaCER). As a member,
we have established a human rights whistleblowing system for use by all stakeholders, including those working in the supply chain, anyone in local communities
suffering negative effects from the standpoint of human rights, and all individuals,
or their representatives, who may be subject to such. We report on our JaCER
membership at the briefings we hold for suppliers each year, and aim to constructa system for receiving reports from further upstream along the supply chain.

* The Pharmaceutical Supply Chain Initiative (PSCI) is a non-profit membership organization
founded in the US in 2013 by six major pharmaceutical companies. The PSCI’s vision is torealize excellence in safety, environmental, and social outcomes across the entire global
pharmaceutical and healthcare supply chain.

Major items that enterprises should follow under the Guiding Principles on Business and Human Rights (UN Approval 2011)

1 Policy commitment ( Guiding Principles ⑯)

In accordance with the full-scale globalization of our business, the impact of ouractivities on rights-holders (those facing human rights issues) around the world is
expanding. The co-creation of value with stakeholders is essential in the provisionof life-changing value. In doing so, we believe that it is necessary to consider thehuman rights of not only our employees but also of those related to our business
partners. Having launched a working team, consisting of the Strategy Division, CSR
Management Department as well as the Procurement and HR departments in
2022 to fulfill the corporate social responsibility that is respect for human rights,
we have commenced initiatives with regard to business and human rights. Having
obtained the assistance of external experts, the specified non-profit organization
Caux Round Table Japan (CRT Japan), under the United Nations Guiding Principles
on Business and Human Rights and based on the demands of society and the laws
and regulations of each country, we are promoting the establishment of aninternal system to fulfill our responsibility to respect human rights as a company.
Moreover, in December 2022 we formulated the Kyowa Kirin Group Human
Rights Policy. Along with conforming to the United Nations Guiding Principles on
Business and Human Rights, this Policy expresses our intent to respect the Declaration of Helsinki in the same manner we would any other international norm as apharmaceutical company. This Policy also stands as our promise to engage ininitiatives involving respect for human rights as based on internal policies andregulations, and states that we will support and respect various international
norms regarding human rights. With this policy as our commitment, we will
promote corporate activities that respect human rights.

2 Human rights due diligence (Guiding Principles ⑰)
Assessment of human rights risks in businessand supply chain

1
AssessRisk Assessment: To Human Rights in the Company and its Supply
Chain Identify potential involvement (Implemented in 2022)
Impact assessment: Presence or absence of risk and its severity
Evaluation from the viewpoint of scale, range, and difficulty ofcorrection

Actions to reduce risks
Incorporate the results of human rights impact
assessments into the response process andrespond appropriately

2Act

By turning PDCA
Continuous
improvement

4
ReportTrack actions and results

Regularly disclose information
Status of responses to adverse human rights impacts andreporting of response results

Conduct a follow-up study to determine if the planis being implemented and if the response to date isappropriate

3 Establishment of a Correction and Complaint Processing Mechanism (Guiding Principles
Stakeholder Engagement

3
Monitoring)Kyowa Kirin Co., Ltd.
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Governance
Basic Policy on Corporate GovernanceDirectors and Board of Directors

Based on our philosophy that states that “The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating newvalue through the pursuit of advances in life sciences and technologies,” on its values as well as on its vision and medium-term business plans, Kyowa Kirin, as a company
responsible for delivering social infrastructure, will work on the enhancement of its corporate governance. It will be achieved not only by ensuring transparency and fairness
in decision-making to achieve sustainable growth and increase corporate value over the medium to long term but also by establishing the structures necessary for speedy
and strong decision-making and the execution of management duties, and for appropriate monitoring and supervisory functions.
The Company is therefore implementing all the principles of the Corporate Governance Code.

Taking into account its fiduciary duties and accountability to shareholders, the Boardof Directors works diligently to realize the Company’s corporate philosophy, andsecure the Group’s sustainable growth while increasing corporate value over the
medium to long term, by establishing effective and efficient corporate governance.
The Board of Directors makes decisions on significant matters pertaining to businessexecution by the Group. This includes the long-term management vision, medium-­term and annual business plans of the entire Group and key Group companies, aswell as statutory matters. The Board of Directors is also responsible for supervising
the execution of directors’ duties, developing basic policy on sustainability andoverseeing the initiatives carried out thereunder, and establishing appropriate
internal control systems across the Group by collaborating with the Internal Audit
Department. In addition to items stipulated by law and the Articles of Incorporation,
the Board of Directors stipulates matters to be resolved by the Board of Directors in
the Regulations of the Board of Directors and delegates other authority related tobusiness execution to the executive officers in charge of each business operation.
With respect to the Board’s composition, the maximum number of directors is
10, in accordance with the Articles of Incorporation. Upon considering the skill
set—that is, knowledge, experience, capabilities and insights—necessary for a
Global Specialty Pharmaceutical Company and ensuring diversity, we establisheda transparent governance system, which is well-balanced as a whole. In order toensure the effectiveness of objective management oversight, independent
directors who have been appointed to the Board from outside the Company arein the majority, and the position of Board Chair is assumed by Mr. Akira Morita,
who is an independent outside director. Policies and procedures for the selectionof director candidates are discussed by the Nomination & Remuneration Consultative Committee and decided by the Board of Directors.
As of March 22, 2024, the Company has nine directors (seven males and two
females, five of whom are independent outside directors). In principle, the Boardof Directors meets once a month to make decisions on important matters suchas management policies and to supervise business execution. In FY2023, theBoard of Directors met 15 times, making decisions on important matters that
included the Company’s management policies and supervising the execution ofduties by directors.

A Transparent Governance Structure That Leverages the Strengths of Outside Directors and Outside Audit & Supervisory Board Members
Corporate Governance Structure (As of March 22, 2024)

Internal

OutsideGeneral Meeting of Shareholders
Audit & Supervisory Board/
Audit & Supervisory
Board Members

Cooperation

Board of Directors

Nomination & Remuneration
Consultative Committee

Chairperson: Independent Outside Director

Chairperson: Independent Outside Director

Audit

Cooperation

PresidentInternal Audit
Department
Executive Committee
Cooperation

Independent
Accounting Auditors

Group CSR Committee
Global Quality Assurance Committee
Group Information Disclosure Committee
Group Financial Management Committee

Internal auditing
Accounting audit

Business Execution Organization(One Kyowa Kirin)

Outside Directors and Audit & Supervisory Board Members
Independence Criteria
In connection with the requirements designed to ensure the independence ofoutside directors and Audit & Supervisory Board members and thereby to ensure
the transparency and objectivity of their governance function as they exert proper
management oversight, Kyowa Kirin has put in place and made public details of its
own unique set of selection standards. To ensure independence in relation to ourGroup, the Company had referred to the provisions for independent outside
directors and Audit & Supervisory Board members stipulated in the enforcement
rules for securities listing regulations of the Tokyo Stock Exchange as well as theindependent directors’ nomination reference model created by the Japan Association of Corporate Directors in 2011.

Functions of Outside Directors/ Audit & Supervisory Board Members
In order to improve the fairness and transparency of its corporate governancewhile ensuring the Group’s sustainable growth and boosting corporate value overthe medium to long term, Kyowa Kirin appoints a majority (five out of nine directors) of independent outside directors who meet the Company’s criteria for independence as outside directors.
Our outside directors have various backgrounds, expertise, and experience.
They apply their wealth of experience and knowledge to the management of theCompany, supervising the Company’s management from an objective and fair
perspective. The Company’s outside Audit & Supervisory Board members apply
their expertise, knowledge, and experience to auditing the Company’s management from an objective and neutral standpoint, ensuring the reliability and soundness of our management.

Audit & Supervisory Board Members and the Audit & Supervisory Board
As an independent body mandated by shareholders, the Audit & Supervisory Boardand its members audit the directors as they carry out their duties as means tosupervising and verifying the status of establishing sound management for theGroup’s sustainable growth and enhancement of corporate value over the medium
to long term. Leveraging the ability of full-time members to gather information
within the Group as well as their independence, Audit & Supervisory Board members actively express their opinions at Board of Directors’ meetings. At the same

Kyowa Kirin Co., Ltd.
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CONTENTSINTRODUCTION

time, Audit & Supervisory Board members also strive to put in place and improve
the framework used to ensure the effectiveness of auditing by each member.
Furthermore, in order to better provide information to outside directors, Audit &Supervisory Board members exchange opinions with outside directors, and provide
information which they have obtained through their auditing activities.
The Audit & Supervisory Board comprises persons with appropriate knowledgeof finance and accounting matters. In accordance with the Company’s Articles ofIncorporation, the Audit & Supervisory Board has at least three members, at least
half of whom are outside Audit & Supervisory Board members.
As of March 22, 2024, the Company had five Audit & Supervisory Board members (three males and two females, three of whom are Outside Audit & Supervisory
Board members).

Evaluation of the Board of Directors’ EffectivenessTo identify gaps between expected roles and responsibilities of the Board of Directors
set forth in the “Kyowa Kirin Corporate Governance Policy” and the actual state of theBoard of Directors in 2022–2023, we conducted an evaluation on the effectiveness of
the Board of Directors. With respect to the evaluation of the Board’s effectiveness,from the perspective of ensuring the effectiveness of governance, we identified
wide-ranging issues, not limited to operational issues of the Board of Directors.

1. The evaluation method for Board effectiveness in 2023
Since 2020, when the current medium-term business plan was formulated, questionnaires and interviews with some executives have been conducted by external
advisors for the purpose of identifying issues from a medium- to long-term­perspective. This year, with the aim of gathering a wider range of opinions, theinterviews were expanded to include all board members. With the advice of theexternal advisors, we analyzed the results of the questionnaires and interviews aswell as exchanged opinions with all directors and Audit & Supervisory Board
members before making an evaluation.

2. Results from 2023 effectiveness evaluation
In making the evaluation, we also referred to the questionnaire scores, comments
arising from the questionnaires and interviews, external advisors’ opinions, andexchanged opinions at Board of Directors’ meetings. The results showed that theBoard of Directors is functioning properly, and we concluded that its effectivenesswas secured. This year, as in the previous year, we set questions for the members of
the Nomination & Remuneration Consultative Committee, an advisory body to theBoard of Directors, and concluded that the appropriateness of access to information as well as agenda/deliberation are ensured.
Corporate Governance Reporthttps://ir.kyowakirin.com/en/management/governance.html

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3. Achievements in addressing issues identified in the 2023 evaluation
Issues from 2023 evaluation

Achievement❶

Further deepening of discussions on
growth investments, etc. for mediumto long-term growth strategies

In addition to providing opportunities to discuss capital policy, we also had discussions on medium- to long-term growthstrategies along with policies for the effective use of capital.
We increased opportunities to discuss the state of progress of strategies against the Medium Term Business Plan.

❷

Deepening Board of Directors’ involvement to further strengthen risk
management

To deepen discussions on further strengthening risk management, the Board of Directors was given the opportunity to
become more deeply involved, such as by holding intensive discussions among its members on risk recognition in view of
medium- to long-term environmental changes.

❸

Discussions relating to the ideal global
governance system

Regarding the state of global governance, we discussed and implemented a structure (the OKK structure) to realize our vision
as a Global Specialty Pharmaceutical (GSP) company. Based on the issues that arose during those meetings, opportunities
were created for discussions on governance methods to further realize where the Company wants to be.

❹

Further improvement of Board of
Directors’ operations to improve its
effectivenessTo ensure sufficient time for deliberations on important matters, we reorganized the structure of deliberations on individual
agenda items and matters to be addressed. We also increased opportunities for reports from departments in charge to further
deepen the understanding of the operations of the departments in charge at Board of Directors’ meetings.

4. FY2024 initiatives
Based on the evaluation results of the Board’s effectiveness, we plan to implement the following measures for improvement in 2024:
FY2024 issues

Initiatives❶

Enhancement of discussion of growthstrategies in light of environmental
changes

Discussing and reporting on the impact of environmental changes on annual plans, etc.
Intensive discussions on the direction of growth strategies based on analysis of the gap between the assumptions madewhen formulating the growth strategies and the current situation, and impact changes❷

Enhancement of discussions on
individual important themes linked to
the growth strategies

Increased opportunities for discussion on individual strategies based on growth strategies designed to realize the vision❸

Creation of a discussion environment
focused on big-picture discussions andsupervisory functions

Further devising of ways to improve Board of Directors’ meeting materials and operations to support the Board of Directors infulfilling its role
Provision of a forum where the Board of Directors can regularly share the scheduled agenda and confirm excesses and­deficiencies in the agenda and future developments

Kyowa Kirin Co., Ltd.
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CORPORATE INFORMATION

Board Members with a Wide Array of Skills
The Board of Directors comprises diverse individuals with various skills (knowledge, experience, etc.). This is to enable the Board of Directors to fulfill its decision-making and management oversight functions appropriately and to enhance the transparency of ourgovernance structure.
Name

Outside Independent

Board Chair

Professional skills

Nomination &Remuneration
Corporate management/
Consultative Committee
Business strategy

Global business

Masashi Miyamoto●●

Yutaka Osawa●●

Takeyoshi Yamashita

●

●

●

●

●

Directors

Shinjiro Akieda

Legal, governmental
affairs and compliance●

Akira Morita●

Yuko Haga

●

●

●

●

Takashi Oyamada●

Chairperson●●

Yoshihisa Suzuki

●

●

●

●

Rumiko Nakata

●

●

●

Finance, accounting
and banking●

Audit & Supervisory
Board Members

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

IT/DX

Sustainability

●

●

●

●

●

●

●
●

●
●

●

●

●

●

●
●

●

●
●

Production and SCM●●●

Mayumi Tamura

R&D

●

●

Hajime Kobayashi
Tomomi Yatsu

Healthcare

●

●

●

Hiroshi Komatsu

HR and labor●●

Toru Ishikura●●

Initiatives to Strengthen Governance of Executive Organization

Expansion of CxO system• Established One Kyowa Kirin, a matrix management system comprising a four-unit regional dimension, a functional dimension, and a
product (franchise) dimension• To strengthen the regional executive oversight function, boards of directors have been established at overseas regional operating companies.
• Appointment of at least two non-executive directors who possess experience in global pharmaceutical business as directors of eachoverseas region• Initiated direct exchanges of opinions between regional non-executive directors, Kyowa Kirin directors, and outside directors

Driving growth as a Japan-based GSP, the following CxOs have been appointed to assist the CEO, anda system put in place by which all functions report to a CxO. They are responsible for improving the
speed of decision-making and the strengthening of the execution system.

Yutaka Osawa
CCO

Paul Carter(Gilead Sciences,
GlaxoSmithKline,
Sterling Health,Arthur Anderson)

Francoise De Craecker(Novartis, Avexis, Chiesi
Farmaceutici, Horizon Pharma,
Raptor Pharmaceuticals,
Pharmacia, Smith & Nephew)

Olivier Daubry(GSK, Celgine, Sanofi)

Iris Kang(Pfizer, AstraZeneca,
Schering-Plough, Bayer)

James Shannon(Novartis, GSK,
Sterling Winthrop)

Paula Soteropoulos(Genzyme, Moderna,
Akcea)

Gary Zieziula(Merck, BMS, Roche,
AMAG Pharmaceuticals)

Takeyoshi Yamashita
Masashi Miyamoto
CEO

Motohiko
Kawaguchi

ASIA PACIFIC
Kyowa Kirin Asia Pacific Pte. Ltd.

NORTH AMERICA
Kyowa Kirin USA Holdings, Inc.

Abdul Mullick
CIBO

CFO

Shoko Itagaki
EMEA
Kyowa Kirin International plc.

CMO

CPO

Yasuo Fujii
Toshiyuki Kurata
CSCO

CSO

Kyowa Kirin Co., Ltd.
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46

Basic policy on remuneration of Directors of the Board and Audit & Supervisory Board Members
Remuneration for Directors of the Board and Audit & Supervisory Board members is designed to increase commitment to the Company’s further sustainable growth and improvement in corporate value, to attract and retain suitable talent who aspire to help theCompany make the leap forward to a Global Specialty Pharmaceutical Company, to motivate executives to contribute to the Company by fulfilling their respective duties as directors or Audit & Supervisory Board members and determined through a transparent
and appropriate process by adopting an objective viewpoint.
In order to realize this basic policy, investigations and deliberations on executives’ remuneration are conducted by the Nomination & Remuneration Consultative Committee, which consists of a majority of outside directors and outside Audit & Supervisory Board
members, and is chaired by an outside Director.

Claw back provision
Kyowa Kirin has established a claw back provision that allows the Nomination & Remuneration Consultative Committee to request the return of Executive directors and executive officer remuneration in the case of such events as illegal acts or violations of laws
and regulations.

Executive Remuneration
Mechanism of linking bonus to performance (Illustrative image)

Variable remuneration

Type

Fixed remuneration

Short-term incentive remuneration(variable)

Medium- to long-term incentive remuneration (variable)

Basic Remuneration

Performance-linked annual bonus

Share-based remuneration
Performance-linked, share-based remuneration
Restricted share-based remuneration(Performance Share Unit)

Payment eligibility

Directors and Audit &­Supervisory Board members

Executive directors

Purpose(Incentive for Officers)

Provide remuneration commensurate with the role andresponsibilities of each officer,
referencing peer company size
and remuneration levels

Raise awareness toward the need tocontribute to improving business performance each fiscal year

Cash
Monthly—Cash
A certain time each year (generally April)
Annual targets (revenue and profit)

Payment method
Payment schedule
Evaluation indicator
Factor for determining
the amount of
remuneration
Approximate ratio(when performancetargets are achieved)

Role and responsibilities

Achievement of targets(Payment rate of 0% to 200%)

1
1Individual
amount ofpayment

Executive directors

Revenue

ProfitPay rate

Pay rate

200%

200%

A

100%
50%
0%

Have executive Directors of the Board of the Clarify the linkage between Executive directors’ remuneraCompany share in the benefits and risks oftion and the Company’s business performance, and share
share price fluctuations with the shareholders price, and thereby provide them with incentives forand enhancing their contribution to increase achieving the Medium Term Business Plan and sustainableof the share price and corporate value more
growth of corporate value, as well as to facilitate their sensethan ever beforeof sharing value with shareholders
Stock
Stock and cash (in roughly equal amounts)
A certain time each year (generally April)—
ROE / CAGR / core operating profit ratio
Base amount determined based on basic remuneration,
Base amount determined based on basic
stock price, and achievement of targets for three consecuremuneration and stock pricetive fiscal years (Variation rate of 0% to 150%)
Around 1 to 1.2

Around 0.4 to 0.5

Reference
bonus
amount

Lower
limit

B

100%
50%

Degree ofUpper achievement
limit

Target
value

0%

Lower
limit

Targetvalue

Degree ofUpper achievement
limit

The weights for Executive directors in FY2023 are A to B =3 to 7.

Mechanism of calculating the degree of achievement of ­performance targets(Illustrative image)
Degree ofachievementof­performancetargets

ROE

CAGR

Core operating
profit ratio

Pay rate

Pay rate

Pay rate

150%

150%

150%

100%
50%
0%

Lower Target Upper
limit value limit

A

100%

Degree ofachievement

0%

50%

Lower Target Upper
limit value limit

B

100%

Degree ofachievement

0%

C

50%

Lower Target Upper
limit value limit

Degree ofachievement

The weights for Executive directors in FY2023 are A to B to C = 1 to 1 to 1.

Around 0.6 to 0.8

Remuneration*1 by position (FY2023)
Breakdown of Remuneration (Millions of yen)
Variable remuneration
Position

Total Remuneration(Millions of yen)Fixed remuneration

Number of
Eligible Officers

330

178

Performance-linked
annual bonus*2
78

29

29

—

—

—

1

89
63

89
63

—
—

—
—

—
—

6
3

Basic Remuneration
Directors (Excluding outside directors)
Audit & Supervisory Board members (Excluding
outside Audit & Supervisory Board members)
Outside directors
Outside Audit & Supervisory Board members

Performance-linked
share-based remuneration*2
11

Non-monetary
remuneration
Restricted share-based
remuneration*2·3
62

Performance-linked remuneration

4*1 Figures include one Director of the Board who retired at the conclusion of the Ordinary General Meeting of
Shareholders in the previous fiscal year. Further, they do not include one Director of the Board and two Audit &Supervisory Board Members to whom no remuneration was paid.
*2 All the amounts of performance-linked annual bonus, share-based remuneration with restriction on transfer andperformance-linked share-based remuneration are the amounts recorded as expenses during the fiscal year underreview. The amount of performance-linked share-based remuneration is the sum of the amounts recorded as
expenses during FY2023 for each of performance-linked share-based remuneration with the performance
evaluation period starting in FY2022 and FY2023 in accordance with the expected degree of achievement of thetargets as of the end of the fiscal year. Performance-linked share-based remuneration is paid and delivered in theform of monetary and non-monetary remuneration after the elapse of the performance evaluation period.
*3 The number of restricted shares delivered to Executive directors during the fiscal year under review was 21,790
shares (paid-in amount per share was ¥2,838, the closing price on March 23, 2023).

Linking important management issues (materiality) with Executive Remuneration (from 2024)
To realize its vision for 2030, the Company has selected key management issues (materiality) as strategic issues in its annual business plans and is monitoring them at Board of Directors’ meetings. From 2024, the evaluation indicators for performance-linked annual
bonuses will include the degree of achievement of non-financial goals, such as “pipeline expansion” and “access to medicines,” set in the annual business plans.

Kyowa Kirin Co., Ltd.
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CONTENTSINTRODUCTION

Nomination & Remuneration Consultative Committee
The Company established the Nomination & Remuneration Consultative Committee as an advisory body to the Board of Directors. Its purpose is to supplement thefunctions of the Board of Directors and further enhance the transparency of ourgovernance system. The Committee deliberates and decides on the Company’s
nomination and remuneration from an objective and fair perspective, and reports
to the Board of Directors. The Nomination & Remuneration Consultative Committee
consists of 10 members, of whom the majority (7) are independent directors. The
chairperson of the Committee is selected from among the independent officers.
The Nomination & Remuneration Consultative Committee deliberates anddecides on proposals for policies regarding: the appointment and removal of
directors, executive officers, Audit & Supervisory Board members and candidates
for these officers; appointment and removal of senior directors; duties of individual
directors; the policy for determining the successor of the current CEO of theGroup; candidates for presidents and other key positions at individual Group
companies; remuneration systems, levels, and remuneration amounts for directors,
executive officers, Audit & Supervisory Board members, and for presidents andother key positions at individual Group companies. After deliberating on anddeciding these matters from an objective and fair perspective, the Committee
presents proposals to the Board of Directors.

TOPICS FORVALUE CREATION

AT A GLANCETOPICS FORVALUE ENHANCEMENT

Companies Act: “The development of systems necessary to ensure that the execution of duties by directors complies with laws and regulations and the articles ofincorporation, and other systems prescribed by the applicable Ordinance of the
Ministry of Justice as systems necessary to ensure the properness of operations of a
Stock Company.” The status of the systems’ maintenance and operation wasreported and confirmed by the Board of Directors on January 19, 2024.
1. Compliance System
2. System of Information Preservation and Maintenance
3. System for Risk Management
4. Effective and Efficient Performance System
5. System for reporting for execution of duties and other Group internal
control system
6. Systems related to Audit & Supervisory Board members

Governance as a listed subsidiary
Ensuring management independence• The Integration Agreement clearly states that management independence isensured, requiring reasonable efforts to maintain Kyowa Kirin as a listed company• M&A decisions are made solely by the Company, without the need for priorconsultation with the parent company

FINANCIAL INFORMATIONCORPORATE INFORMATION

47• In accordance with the Company’s own investment policy, the interest rate onloans is determined based on reasonable judgment after considering market
interest rates based on the loan period, and the loan period is shortened (inprinciple, one month)• Developing systems that are compatible with the revised CG Code/new market
requirements

Decision-making process that starts with protecting minority shareholders• Ensuring that independent outside directors are in the majority• An independent outside director elected as chairperson . Directors from the parent
company do not participate in resolutions when they are special interested parties• In the event that independent outside directors do not constitute the majority at
the time of important transactions, etc. with the parent company, the Board of
Directors shall establish, as an advisory body to the Board of Directors, a Conflictsof Interest Supervisory Committee for Intercompany Transactions, that willconsist of independent outside directors to conduct deliberations and considerations, and report to the Board of Directors• Consisting of a majority of outside directors, the Nomination and Remuneration
Consultative Committee deliberates and decides on selecting and deselecting
independent directors from an objective and fair perspective and reports back to
the Board of Directors.

CEO Succession Planning
The Nomination & Remuneration Consultative Committee conducts ongoing
discussions about the selection and development of individuals who, from theperspective of KKC, would be ideally qualified for the position of CEO and reports
its findings to the Board of Directors. The discussion theme includes knowledge,
skills and experience needed for the role of CEO, as well as the following ideal
profile of CEO, for example:• As a leader in a human life and health-related business, deeply understand andfully commit to putting into practice the Company’s philosophy and core values.
• Truly empathize with and have a strong sense of responsibility in delivering“life-changing value” to people facing illness.
• Possess the determination to want to create value for society and to change theCompany for the better while leading the organization with unwavering resolve
even when faced with difficulties.
• Competence to create and instill a future vision within organizations andguide that vision beyond national borders toward the achievement of theCompany’s strategies.

Internal Control
Based on the fundamental principles of the internal control system of its parent
company, Kirin Holdings Company, Limited, the Company steadily maintains andoperates internal control systems in line with Article 362, paragraph 4, item VI of the

FOCUS
ON

Synergies with the Kirin GroupThe Kirin Group aims to become one of the world’s leading CSV companies bycreating value in areas ranging from food to medicine. We are the only Kirin
Group company whose core business is medicine.
We believe that the management resources of the Kirin Group are
extremely useful for realizing our goal of creating life-changing value. The Kirin
Group’s knowledge and expertise contributes greatly to our business. In
production management and engineering, it helps us establish our businessfoundation. In environmental conservation and supply stability, it helps us
fulfill our social responsibility.
We also believe that connecting the health science field, on which the Kirin
Group focuses, and the medical field, in which we are involved, offers many
opportunities for us to pursue our goal of going beyond pharmaceuticals tomeet society’s medical needs.

Solving Issues around
Our Own Pharmaceutical
Products Using accumulated data, patient insights, etc.
 Establishing a project team for new value creation & digitaltransformation

Maximizing thevalue of existing drugs
and developing
innovative solutions

Solving Issues throughGroup Synergies Leverage opportunities created by connecting our pharmaceuticals business with the Kirin Group’s the health science field.
 Incorporate synergies into intra-group projects under individual
contracts

Create new value toimprove patients’ ­quality of life

Createlife-changing
value beyond
pharmaceuticals

Kyowa Kirin Co., Ltd.
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48

Implementation Status of Dialogue with Shareholders, etc.
Policy for constructive dialogue with shareholders• Understanding that constructive dialogue with all shareholders will lead tofurther improvement in corporate governance and, in turn, to greater corporate
value over the medium to long term, the Company actively responds in principle
to requests for dialogue from all shareholders, and voluntarily offers opportunities
for constructive dialogue based on the shareholder composition, which is periodically confirmed.
• Requests for dialogue from individual shareholders are dealt with mainly by the
IR Group of the Corporate Communication Department, under the supervision of
the officer in charge of IR. If the officer in charge of IR determines that a meetingis, within reason, necessary between the requesting shareholder and the president, a director (including outside directors) or an executive officer, such ameeting will be arranged.
• Depending on the purpose of the dialogue, the Finance Department, the­Corporate Planning Department, the Legal Department and other related
departments will provide their cooperation to the officer in charge of IR toenhance the content of the dialogue with the shareholders.
• The Company plans and implements presentation meetings and shareholder/investor visits to explain the Company’s long-term business vision, medium-term
and annual business plans, financial results, R&D, ESG, and other matters to deepen
understanding of the Company and encourage dialogue with shareholders.
• The Company pays close attention to the timeliness, appropriateness and impartiality of dialogues, gives explanations in a sincere manner, listens to the opinionsof all shareholders, and endeavors to engage in interactive communication. The
officer in charge of IR provides reports on the opinions of and questions from allshareholders periodically or on an as-needed basis to the CEO, directors, Audit &Supervisory Board members and executive officers.

Numberof times

Organizers

Finance

Sales

R&D

Financial results
briefings (Online
meetings)

4 timesPresident*, officers
in charge●●●

IR events

3 times

Officers in charge,
outside director

IR interviews withthe president

25 times

President, officers
in charge●

IR interviews withmanagement

31 times

Officers in charge

IR interviews by
officer in charge ofIR

132 times

Officer in charge
of IR

Event

ESG

Other
●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

Twice a year, the Company holds a Group Information Disclosure Committee
meeting, chaired by the president, to discuss and decide on its policies concerning
communications with shareholders, investors, and other stakeholders. Relevant
officers attend the committee meetings, deliberate and make decisions based on
the status of communication with all parties and matters of interest, and meeting
content is reported to the Board of Directors.
With regard to the IR events and IR interviews held by the Company, our IR staff
compiles the status of dialogue with shareholders and market reactions and reportsthat information to all officers, including outside directors, and relevant departments.

Our ESG initiatives are highly respected within the global pharmaceutical industry,
with MSCI ESG Ratings of AA (Leader) and Sustainalytics ESG Risk Ratings of 18.9
(Low Risk). Having been selected for inclusion in multiple ESG indices both­domestically and internationally, Kyowa Kirin is included in all ESG indices forJapanese equities selected by the Government Pension Investment Fund (GPIF).
!

!

●* Participates twice a year: second quarter financial results and annual financial results.

Enhancing information disclosure
To further enhance dialogue with investors and shareholders, we strive to disclose
high-quality information with consideration for transparency and fairness inaccordance with our disclosure policy. As information disclosure tools, in addition
to TDnet provided by the Tokyo Stock Exchange (TSE), we utilize the Company
website for shareholders and investors, which has excellent immediacy andfairness. With some exceptions, in principle information is disclosed simultaneously in both Japan and the UK.
Introduction of website for shareholders and investors!

Morningstar Japan
ex-REIT Gender
Diversity Tilt Index!

!

https://ir.kyowakirin.com/en/index.html

Ordinary General Meetings of Shareholders with emphasis on dialogue
Implementation status of IR activities

Main assessments from external organizations (as of February 2024)

To enable shareholders to have sufficient time to review the general meeting
agenda items, in accordance with the Corporate Governance Code the Company
sends out convocation notices approximately three weeks prior to a meeting and,via the electronic delivery system, the electronic version is posted on the websitesof the Company and the TSE even before the notices are sent. Additionally, securities reports are disclosed before general meetings of shareholders. Furthermore, inconsideration of our overseas investors, we provide English translations of convocation notices and securities reports as well as an electronic voting platform. With
regard to the operations of the general meetings of shareholders, for those whowill not be attending on the day of the event, we will be live streaming andaccepting questions in advance. After a general meeting of shareholders, weupload to our website a video of that day’s proceedings, including shareholder
Q&A and replies to the preliminary questions.
We will continue to aim for more open shareholder meetings in the years to come.

! FTSE Russell (the trading name of FTSE International Limited and Frank Russell Company) confirms that
Kyowa Kirin Co., Ltd. has been independently assessed according to the index criteria, and has satisfied therequirements to become a constituent of the FTSE Blossom Japan Index. Created by the global index
provider FTSE Russell, the FTSE Blossom Japan Index is designed to measure the performance of Japanesecompanies demonstrating strong Environmental, Social and Governance (ESG) practices. The FTSE Blossom
Japan Index is used by a wide variety of market participants to create and assess responsible investment
funds and other products.
! FTSE Russell (the trading name of FTSE International Limited and Frank Russell Company) confirms that
Kyowa Kirin Co., Ltd. has been independently assessed according to the FTSE Blossom Japan Sector
Relative Index criteria, and has satisfied the requirements to become a constituent of the FTSE Blossom
Japan Sector Relative Index Series. The FTSE Blossom Japan Sector Relative Index is used by a wide variety
of market participants to create and assess responsible investment funds and other products.
! The inclusion of Kyowa Kirin Co., Ltd. in any MSCI index, and the use of MSCI logos, trademarks, service
marks or index names herein, do not constitute a sponsorship, endorsement or promotion of Kyowa Kirin
Co., Ltd. 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.

For details on assessments from external organizations, please see the External
Assessments section in the ESG-related information on our website.

https://www.kyowakirin.com/sustainability/esg_data/index.html

Kyowa Kirin Co., Ltd.
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49

Compliance
Compliance at Kyowa Kirin refers to acting ethically and with integrity in a socially responsible manner, with respect to all business activities of our Group.
Code of Conduct and Group Policies

Education and Training

The Kyowa Kirin Group Code of Conduct sets forth the actions that should be takenby everyone working in the Kyowa Kirin Group. The Code of Conduct is translated
into local languages and disseminated to Group companies all around the world.
All executives and employees of the Group pledge to comply with the Code of
Conduct. Their understanding and compliance is monitored through employee
awareness surveys and other means. We also encourage all partners in our supply
chain to comply with the Code of Conduct. In addition, action policies related toindividual business areas have been established as the Kyowa Kirin Group Policies.
The Code of Conduct and the Group Policies are continuously reviewed in lightof changes in the external environment, such as laws and regulations, as well aschanges in the internal environment and any revisions must be approved by the
Board of Directors.

Kyowa Kirin conducts annual training programs, including Code of Conduct,
through group workshops and e-learning, in order to foster an organizational
culture that can flexibly respond to changes in social norms. In 2023, global
e-learning on the Code of Conduct was conducted for all executives andemployees, including contract and temporary employees (6,598 people). Other
training sessions were held on topics such as anti-bribery and anti-corruption,
personal information protection, and promotional codes.
Every year, we also conduct a Kirin Group-wide compliance and human rights
awareness survey (4,695 people in Japan responded as the Kyowa Kirin Group in2023) and a Kyowa Kirin Global Engagement and Motivation Survey (5,840 people
in Japan and overseas responded in 2023). The results of the survey help to identify changes in employee awareness and issues that need to be addressed, and are
utilized in formulating the Group’s initiatives.

Kyowa Kirin Group — Outline of the Relationship between the Management
Philosophy and Kyowa Kirin Group Policies

https://www.kyowakirin.com/sustainability/group_policy/index.html

Governance
Under the supervision of the Chief Compliance Officer (CCO, Representative
Director and Executive Vice Presi­dent), the Kyowa Kirin Group has appointed a
Global CSR Head and established the CSR Management Department to assist the
Head in their duties. The Global CSR Head and the CSR Management Department
take the leading role in compli­ance, formulating and implementing compliancemeasures on a global and regional basis in collaboration with the Regional CSR
Heads*1, who are responsi­ble for compliance in the four regions of Japan, North
America, EMEA, and APAC.
The Kyowa Kirin Group has established regional CSR committees in the four
regions to discuss compliance-related activities. These committees are held on aquarterly basis to discuss the status of activities and issues that are global or
specific to each region*2. In addition, a Group CSR Committee meeting, in which
all function heads and the compliance managers from each region participate, isheld twice a year to deliberate on compliance strategies and action plans for theentire Group, and to report on the progress of activities during the year. The GroupCSR Committee is chaired by the Company’s Representative Director and Executive Vice President. Important matters discussed in these committee meet­ings arereported to the Board of Directors.
*1 Currently, the Global CSR Head also serves as the Regional CSR Head for Japan.
*2 In Japan, held semiannually. Important issues discussed at each Regional CSR Committee arecompiled by the secretariat and reported to the Regional CSR Committee held in Japan.

Whistleblowing System
The Kyowa Kirin Group has put in place the Compliance Line, whistleblowing
system, in order to prevent, detect at an early stage and correct acts that areagainst the Kyowa Kirin Group Code of Conduct, as well as acts that seriously
damage the brand value of the Kyowa Kirin Group. We have introduced a process
under which reports concerning directors are passed directly to company audi­tors.
On top of the strict adherence to confidentiality and a rule that those who reportwill not be subjected to any retaliation, steps have been taken to establish aninternal and external point of contact for reporting that can be accessed by
telephone, electronic and postal mail as well as online tools. Reports can also be
filed anonymously. In this manner, every effort is being made to create a simple
and easy reporting environment. Moreover, messages from the CEO on such topics
as the importance of the Compliance Line, confidentiality and non-retaliation aresent out on a continuous basis. The point here is to ensure that employees gain abetter understanding of the system through group training and e-learning andwhile maintaining a continuous awareness toward each point of contact forreporting. Details of the Compliance Line are readily available on the Company’s
website and posters displayed throughout the workplace. In 2023, the ComplianceLine received a total of 34 reports in Japan and overseas.

Overseas subsidiaries operate local whistleblowing systems in each region.
We also established and operate a global line that enables overseas subsidiar­ies’ employees to report directly to the Group’s head office in Japan in theirlocal language.

Future Initiatives
Kyowa Kirin is strengthening its global compliance management system with theaim of becoming a global specialty pharmaceutical company. In all areas of ourcompliance functions (governance/organizational structure, policies and procedures, education and training, monitoring, and risk management) and of compliance categories, including our Group Policies, the entire Group will work together
to strengthen compliance in accor­dance with a roadmap created with the aim ofestablishing the ideal compliance management system for our Group.

Kyowa Kirin Group Code of Conduct (Summary)
Introduction
1. Purpose of this Code of
Conduct

5. Raising questions and concerns

2. Scope of this Code of Conduct
4. Role of Managers

7. Response to non-compliant
actions with this Code of
Conduct

Chapter 1.
Relationship with Society

Chapter 5.
Environmental Preservation

Chapter 2.
Relationship with Employees

Chapter 6.
Information Management

Chapter 3.
Compliance with Rules

Chapter 7.
Risk Management

3. Role of Officers

Chapter 4.
Respect for Human Rights

6. Prohibition of retaliation

Kyowa Kirin Co., Ltd.
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Risk Management
To earn the trust of its customers and society, the Kyowa Kirin Group identifies and responds appropriately to the various risks that arise in conducting its business activities.
Kyowa Kirin Group Risk Management
The Kyowa Kirin Group recognizes that the realization of its vision, based on its
corporate philosophy will lead to sustainable growth and the enhancement ofcorporate value over the medium to long term. In order to safeguard its corporate
value from threats, the Group engages in enterprise risk management. Throughvarious opportunities and the taking of appropriate risks, our risk management
endeavors also help create new corporate value.

Risk Management System
In the Kyowa Kirin Group, business functions identify risks based on changes intheir internal and external environments and analyze the degree of impact ofidentified risks on management and the likelihood of their occurrence. After
discussing and adjusting the analysis results while conversing with business
functions concerning internal and external environmental changes and risk
trends, the CSR Committee secretariat organizes and assesses risks by category,
and identifies the principal risks. In addition to confirming the appropriateness ofidentifying principal risks, CSR Committees monitor measures aimed at mitigating risks as well as progress while organizing and supervising the risk management of business functions. Moreover, the Group CSR Committee meets twice ayear to deliberate on the Group’s overall risk management strategy and action
plan and monitors the status of activities during the year. Details of principal risk
mitigation measures and the monitoring results discussed by the Committee arereported to the Board of Directors.
The Kyowa Kirin Group is also moving forward with the digitalization of our risk
management system, having introduced an IT system for centrally managing therisks of the entire group in a database. After business functions register risk ledgers
and incident information in the database, the information is shared using a workflow with divisions that support, advise, and monitor risks from specialized andcompany-wide risk standpoints. This enables visualization of critical risks on a risk
map. In this way we are working to develop a system that enables the effective
and efficient monitoring of risks.

Risk Management System

We define “crises” as situations that may have a profound impact on our businessand require a rapid response among those that inhibit the achievement of ourmanagement goals. In addition, we define “crisis management” as activities thatminimize the impact on our business when risks evolve into crises. In the Kyowa
Kirin Group, crisis management is executed autonomously by area task forces inthree layers—global, regional, and local—and the Area Crisis Management Teamthat responds using specialized expertise. In the event that a global response isrequired, each crisis management team will work together to build a system toquickly reduce any impact. In addition, we repeatedly conduct global crisis BCP
exercises (cyberattacks, information leaks caused by the use of generative AI,
natural disasters, shipping suspension, etc.), which connect each region, including
Japan, with our global headquarters, and work to strengthen our crisis response
and business continuity systems based on worst-case scenarios. Through these
exercises, we improve our response capabilities, review our risk assessment andmitigation measures, and monitor to detect any signs of risk. In this way, we aim
to create a resilient organization that is able to adapt flexibly to difficult situations.

Crisis Management System
Risk Management System
Group CSR Committee

Regional
CSR Committee
Japan*1

Crisis Management System

Regional
CSR Committee
North America

Global Crisis Management Team
Held: Twice a year

Regional
CSR Committee
EMEA*2

Held: Once every halfyear or quarterly

Regional CSR
Committee
APAC

CSR Committee Secretariat: Risk identification by means of risk map creation
Business functions: Identify/analyze risks using a risk ledger*1 Other regions’ reports collated and presented in Japan.
*2 EMEA stands for Europe, Middle East and Africa

Function
CrisisManagement
Team

Regional Crisis
Management
Team
Japan

Regional Crisis
Management
Team
North America

Regional Crisis
Management
Team
EMEA

Regional Crisis
Management
Team
APAC

Local Crisis­Management
Team(Business sites, etc.)

Local Crisis­Management
Team(Business sites, etc.)

Local Crisis­Management
Team(Each country, etc.)

Local Crisis­Management
Team(Each country, etc.)

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To achieve sustainable growth and medium- to long-term
improvement in corporate value for the Kyowa Kirin Group,
we will ensure transparency and fairness in our decision-making as
we strive for decision-making that is timely and decisive.

51

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Directors’ Profiles

Representative Directorof the Board, President
and Chief Executive
Officer (CEO)MasashiMiyamoto, Ph.D.

Representative Directorof the Board, Executive
Vice President and Chief
Compliance Officer (CCO)

Yutaka Osawa

Director of the Board,
Senior Managing
Executive Officer andChief Medical Officer(CMO)

Takeyoshi
Yamashita, Ph.D.

Apr. 1985 Joined Kirin Brewery Company, Limited (presently Kirin Holdings Company, Limited)
Apr. 2011 Director, Regulatory Affairs Department, Pharmacovigilance and Quality Assurance
Division, Kyowa Hakko Kirin Co., Ltd. (presently Kyowa Kirin Co., Ltd.)Mar. 2012 Executive Officer, Director, Regulatory Affairs Department, Pharmacovigilance andQuality Assurance Division, Kyowa Hakko Kirin Co., Ltd.
Jul. 2014 Executive Officer, Director, Strategic Product Portfolio Department andRegulatory Affairs Department, Pharmacovigilance and Quality Assurance Division,
Kyowa Hakko Kirin Co., Ltd.
Apr. 2015 Executive Officer, Director, Strategic Product Portfolio Department,
Kyowa Hakko Kirin Co., Ltd.
Mar. 2017 Director of the Board, Managing Executive Officer, Strategic Product Portfolio Department,
Kyowa Hakko Kirin Co., Ltd.
Apr. 2017 Director of the Board, Managing Executive Officer, Director,
Corporate Strategy & Planning Department, Kyowa Hakko Kirin Co., Ltd.
Mar. 2018 Representative Director of the Board, President, Kyowa Hakko Kirin Co., Ltd.
Apr. 2024 Representative Director of the Board, President & Chief Executive Officer(CEO),Kyowa Kirin Co., Ltd. (to present)

Reasons for Selection

Director of the Board

Shinjiro Akieda

The company has judged that Dr. Masashi Miyamoto is the right person to perform the decision-­making role on material matters of management and supervising the execution of operations as
Representative Director of the Board, utilizing his extensive experience and high level of insight
regarding overall business management, to push forward various measures for CSV management
and for making a leap forward to become a global specialty pharmaceutical company with his strong
leadership, and to promote sustainable growth as well as efforts aimed at enhancing the corporate
value of the Group.

Apr. 1984 Joined Kyowa Hakko Kogyo Co., Ltd.
Apr. 2007 Director, Pharmaceutical Production Development Department,
Kyowa Hakko Kogyo Co., Ltd.
Oct. 2008 Director, CMC Development Department, Development Division,
Kyowa Hakko Kirin Co., Ltd. (presently Kyowa Kirin Co., Ltd.)
Apr. 2009 Director, Production Planning Department, Production Division,
Kyowa Hakko Kirin Co., Ltd.
Mar. 2013 Executive Officer, Director, Production Planning Department, Production Division,
Kyowa Hakko Kirin Co., Ltd.
Apr. 2014 Executive Officer, Head, Production Division, Kyowa Hakko Kirin Co., Ltd.
Mar. 2017 Managing Executive Officer, Head, Production Division, Kyowa Hakko Kirin Co., Ltd.
Mar. 2018 Director of the Board, Managing Executive Officer, Head, Production Division,
Kyowa Hakko Kirin Co., Ltd.
Mar. 2019 Representative Director of the Board, Executive Vice President, Kyowa Hakko Kirin Co., Ltd.
Apr. 2024 Representative Director of the Board, Executive Vice President & Chief Compliance Officer(CCO), Kyowa Kirin Co., Ltd. (to present)

Reasons for Selection

The company has judged that Mr. Yutaka Osawa has profound knowledge and a high level of insightgained through his extensive experience regarding research and development, overseas development and manufacturing, and is the right person to fully perform the decision-making role onmaterial matters of management and supervising the execution of operations as Director of theBoard, and to firmly deliver the important mission of ensuring stable supply of high quality products
as a pharmaceutical company.

Apr. 1987 Joined Kirin Brewery Company, Limited (presently Kirin Holdings Company, Limited)
Apr. 2010 Director, Innovative Drug Discovery Laboratories, Research Division,
Kyowa Hakko Kirin Co., Ltd. (presently Kyowa Kirin Co., Ltd.)
Apr. 2012 Director, Research Planning Department, Research Division, Kyowa Hakko Kirin Co., Ltd.
Apr. 2014 Director, Research Core Function Laboratories, Research Functions Unit, R&D Division,
Kyowa Hakko Kirin Co., Ltd.
Apr. 2015 Director, Regulatory Affairs Department,
Pharmacovigilance and Quality Assurance Division, Kyowa Hakko Kirin Co., Ltd.
Mar. 2017 Executive Officer, Director, Regulatory Affairs Department,
Pharmacovigilance and Quality Assurance Division, Kyowa Hakko Kirin Co., Ltd.
Mar. 2019 Executive Officer, Director, Corporate Strategy & Planning Department,
Kyowa Hakko Kirin Co., Ltd.
Mar. 2021 Managing Executive Officer, Director, Corporate Strategy & Planning Department,
Kyowa Kirin Co., Ltd.
Apr. 2022 Managing Executive Officer, Vice President Head, Strategy Division, Kyowa Kirin Co., Ltd.
Mar. 2023 Senior Managing Executive Officer, President Head, Strategy Division, Kyowa Kirin Co., Ltd.
Apr. 2023 Director of the Board, Senior Managing Executive Officer, Kyowa Kirin Co., Ltd.
Apr. 2024 Director of the Board, Senior Managing Executive Officer & Chief Medical Officer (CMO),
Kyowa Kirin Co., Ltd. (to present)

Reasons for Selection

Dr. Takeyoshi Yamashita possesses abundant experience in management strategy, product strategy,
and regulatory affairs as well as a high level of foresight from a strategic point of view. The company
has judged him to be the right person to perform a decision-making role on material matters ofmanagement and a supervisory role in the execution of operations as Director of the Board and, as adriving force behind its leaps toward a global specialty pharmaceutical company, to be capable ofpromoting the development of the company’s global management system in an expansive manner.

Apr. 1988 Joined Kirin Brewery Company, Limited (presently Kirin Holdings Company, Limited)
Mar. 2010 Chairman and President, Taiwan Kirin Company, Limited
Mar. 2013 Executive Officer and General Manager of Corporate Planning Department,
Mercian Corporation
Mar. 2015 Executive Officer and General Manager of Corporate Planning Department,
Kirin Beverage Company, Limited
Mar. 2017 Senior Executive Officer and General Manager of Corporate Planning Department,
Kirin Beverage Company, Limited
Mar. 2018 Executive Officer and General Manager of Corporate Planning Department,
Kirin Brewery Company, Limited
Mar. 2019 Executive Officer and General Manager of Corporate Strategy Department,
Kirin Holdings Company, Limited
Mar. 2020 Executive Officer and General Manager of Corporate Strategy Department,
and Manager of DX Strategy Office, Kirin Holdings Company, Limited
Jan. 2022 Executive Officer and General Manager of Corporate Strategy Department,
Kirin Holdings Company, Limited
Mar. 2022 Senior Executive Officer and General Manager of Corporate Strategy Department,
Kirin Holdings Company, Limited
Mar. 2023 Senior Executive Officer (Financial Strategy, IR), Kirin Holdings Company, Limited
Mar. 2024 Director of the Board, Senior Executive Officer and CFO (Financial Strategy, IR),
Kirin ­Holdings Company, Limited (to present)
Director of the Board, Kyowa Kirin Co., Ltd. (to present)

Reasons for Selection

Director of the Board
OutsideIndependent

TakashiOyamadaThe company has judged that Mr. Shinjiro Akieda is the right person to perform the role of decision
making on material matters of management and supervising the execution of operations as Directorof the Board, utilizing his extensive experience and high level of insight regarding overall business
management, and to promote tight-knit cooperation with Kirin Group companies which havevarious business bases aimed at realizing people’s health and affluence by responding to diverse
medical needs and providing solutions.

Director of the Board
OutsideIndependent

Akira Morita

Oct. 1993 Professor, Faculty of Law and Economics, Chiba University
Apr. 1994 Professor, The University of Tokyo Graduate Schools for Law and Politics
Apr. 2004 Dean, Professor, Graduate School of Public Policy, The University of Tokyo
Jul. 2008 Director, Policy Alternatives Research Institute, The University of Tokyo
Apr. 2011 Chairman, Central Social Insurance Medical Council, Ministry of Health, Labour and Welfare
Apr. 2012 Professor, Department of Political Studies, Faculty of Law, Gakushuin University
Jun. 2012 Emeritus Professor, The University of Tokyo (to present)
Apr. 2014 Director-General, National Institute of Population and Social Security ResearchAug. 2014 Adjunct Professor, National Graduate Institute for Policy Studies
Apr. 2017 Professor, Department of Policy Studies, Tsuda University
Visiting Professor, Mie University Graduate School of Medicine
Outside Member, Administrative Council, The University of Tokyo (to present)
Apr. 2018 Director-General, Research Institute of Science and Technology for Society,Japan Science & Technology Agency
Mar. 2019 Outside Director of the Board, Kyowa Hakko Kirin Co., Ltd. (presently Kyowa Kirin Co., Ltd.)(to present)
Apr. 2019 Visiting Professor, Kanagawa University of Human Services (to present)
Jul. 2020 Representative Director, Next Generation Fundamental Policy Research Institute (to present)
May 2022 Data Health Operations Advisor, Health Insurance Claims Review & Reimbursement
Services (to present)

Reasons for Selection

Director of the Board
OutsideIndependent

Yoshihisa Suzuki

The company has judged that Mr. Akira Morita will utilize his academic experience and extensive
knowledge as a researcher in the field of policy studies as well as his experience serving on deliberating
committees for national and local government, and he is the right person to contribute toward
reinforcing the company’s governance function and in other ways by supervising the execution ofoperations from an independent standpoint and reflecting in the company’s management theperspective of protecting the rights of general shareholders.

Apr. 1989 Senior Consultant, Tokyo Office, Price Waterhouse Consultants
Apr. 1991 Representative, Haga Management Consulting Office (to present)
Jun. 2000 Director, Link World Co., Ltd.
Feb. 2010 Director, Social Welfare Corporation Fujikenikukai (to present)
Apr. 2010 Visiting Professor, Department of Policy Management, Faculty of Policy Management,
Shobi University
Apr. 2017 Associate Professor, Graduate School of Management, NUCB Business School
Mar. 2019 Outside Director of the Board, Kyowa Hakko Kirin Co., Ltd. (presently Kyowa Kirin Co., Ltd.)(to present)
Apr. 2020 Professor, Graduate School of Management, NUCB Business School (to present)
Jun. 2020 Outside Director, MinebeaMitsumi Inc. (to present)

OutsideIndependent

Yuko Haga, Ph.D.

The company has judged that Dr. Yuko Haga will utilize her wealth of experience in the fields of
medical treatment, nursing care, and healthcare, gained from her wide-ranging activities as amanagement consultant, as well as her insight as a researcher in corporate strategy, and she is theright person to contribute toward reinforcing the Company’s governance function and in other ways
by supervising the execution of operations from an independent standpoint and reflecting in the
Company’s management the perspective of protecting the rights of general shareholders.

Reasons for Selection

Mr. Takashi Oyamada possesses an extremely high-level of knowledge on management from hislong experience as a banking executive, and he has knowledge and insight into a broad range ofindustries based on his abundant experience in the financial sector. On the basis not only of his
specialist viewpoint of the financial sector but also of his experience as a manager, the company has
judged him to be the right person to make decisions on material matters and supervise theexecution of operations.

Apr. 1979 Joined ITOCHU Corporation
Apr. 2003 General Manager, Aerospace, Space and Electronics Division, ITOCHU Corporation
Jun. 2003 Executive Officer, ITOCHU Corporation
Apr. 2006 Managing Executive Officer, ITOCHU Corporation Executive Vice President and CAO,
ITOCHU International Inc.
Apr. 2007 President and CEO, ITOCHU International Inc.
Jun. 2011 Executive Vice President, JAMCO Corporation
Jun. 2012 President and CEO, JAMCO Corporation
Jun. 2016 Senior Managing Executive Officer, Member of the Board, ITOCHU Corporation
Apr. 2018 President and Chief Operating Officer (COO), Member of the Board, ITOCHU Corporation
Apr. 2020 President and Chief Operating Officer (COO), Chief Digital Officer (CDO), andChief Information Officer (CIO), Member of the Board, ITOCHU Corporation
Apr. 2021 Vice Chairman, Member of the Board, ITOCHU Corporation
Mar. 2022 Outside Director of the Board, Kyowa Kirin Co., Ltd. (to present)
Apr. 2022 Vice Chairman, ITOCHU Corporation
Jun. 2022 Outside Director, OMRON Corporation (to present)
Apr. 2023 Senior Vice Representative for External Affairs, ITOCHU Corporation
Apr. 2024 Advisory Member, ITOCHU Corporation (to present)

Reasons for Selection

The company has judged Mr. Yoshihisa Suzuki is the right person to make decisions on importantmatters and supervise the execution of business operations based on his experience in corporate
management as former president of ITOCHU Corporation overseas subsidiaries, in being in charge ofdivisions related to aviation and electronic information at ITOCHU Corporation, and as former presidentof a manufacturing company. Mr. Yoshihisa Suzuki also has knowledge and insight based on his
extensive experience in Japan and overseas and has experience in financial activities throughorganization such as Japan Business Federation.

Apr. 1979 Joined Esso Sekiyu K.K.
Apr. 1996 Joined Center for Socio-Economic Research K.K.
Apr. 2000 Joined Pfizer K.K.
Dec. 2011 Head of HR and Global Operations, Pfizer K.K.
Mar. 2012 Corporate Officer, Pfizer K.K.
Jan. 2014 Director of the Board, Corporate Officer, Pfizer K.K.
Mar. 2018 Executive Officer, in charge of Diversity & Inclusion, Mitsubishi Chemical Corporation
Apr. 2019 Managing Executive Officer, Supervising — Human Resources Department,
Mitsubishi Chemical Corporation
Apr. 2020 Director of the Board, Managing Executive Officer,
Supervising — Administration Department, Public Relations Department,
Human Resources Department, Mitsubishi Chemical Corporation
Apr. 2022 Director of the Board, Mitsubishi Chemical Corporation
Mar. 2023 Outside Director of the Board, Kyowa Kirin Co., Ltd. (to present)

Reasons for Selection
Director of the Board

Apr. 1979 Joined The Mitsubishi Bank, Limited (presently MUFG Bank, Ltd.)
Jan. 2006 Executive Officer, The Bank of Tokyo-Mitsubishi UFJ, Ltd. (presently MUFG Bank, Ltd.)
Jun. 2009 Managing Director, The Bank of Tokyo Mitsubishi UFJ, Ltd.
Member of the Board of Directors, Mitsubishi UFJ Financial Group, Inc.
May 2012 Managing Executive Officer, The Bank of Tokyo-Mitsubishi UFJ, Ltd.
May 2013 Senior Managing Executive Officer, The Bank of Tokyo-Mitsubishi UFJ, Ltd.
Jun. 2014 Representative Director, Deputy President, The Bank of Tokyo-Mitsubishi UFJ, Ltd.
Jun. 2015 Member of the Board of Directors, Representative Corporate Executive,
Deputy President and Group COO, Mitsubishi UFJ Financial Group, Inc.
Apr. 2016 Representative Director, President & CEO, The Bank of Tokyo-Mitsubishi UFJ, Ltd.
Member of the Board of Directors, Mitsubishi UFJ Financial Group, Inc.
Jun. 2017 Senior Advisor, The Bank of Tokyo-Mitsubishi UFJ, Ltd. (to present)
Jun. 2018 Director and Vice Chair, The Japan Institute of International Affairs (to present)
Chairman, The Mitsubishi Economic Research Institute (to present)
Dec. 2018 Outside Director, Mitsubishi Research Institute DCS Co., Ltd. (to present)
Jun. 2019 Outside Director, Mitsubishi Electric Corporation
Outside Director, Isetan Mitsukoshi Holdings Ltd.
Mar. 2021 Outside Director of the Board, Kyowa Kirin Co., Ltd. (to present)

Director of the Board
OutsideIndependent

Rumiko Nakata

Reasons for Selection

Having consistently been in charge of human resource departments throughout her career,
Ms. Rumiko Nakata possesses abundant knowledge and insight regarding people management
based on her experience in promoting various personnel measures, such as diversity promotion andwork style reform, as a director and executive officer. As she has also gained experience as a memberof the Japan Association of Corporate Executives, the company has judged her to be the right person
to supervise the company’s management.

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Audit & Supervisory Board Members’ Profiles/Executive Officers
Apr. 1986 Joined Kyowa Hakko Kogyo Co., Ltd.
Feb. 2009 CFO, Hematech, Inc.
Apr. 2012 Manager, Corporate Planning Department, Kyowa Hakko Kirin Co., Ltd. (presently Kyowa
Kirin Co., Ltd.)
Apr. 2015 Deputy Director, General Affairs Department, Kyowa Hakko Kirin Co., Ltd.
Apr. 2016 Deputy Director, General Affairs Department, and Leader, Corporate Secretariat Group,
General Affairs Department, Kyowa Hakko Kirin Co., Ltd.
Mar. 2018 Audit & Supervisory Board Member (Full-time), Kyowa Hakko Kirin Co., Ltd. (to present)

Apr. 1983 Joined Tokyo Electron Ltd.
Oct. 1986 Joined Deloitte Touche Tohmatsu LLC
Sep. 1990 Registered as Certified Public Accountant
Oct. 2001 Joined New Tokyo International Law Office Admitted to Tokyo Bar Association
Jun. 2009 Outside Auditor, Calbee, Inc.
Jun. 2010 Outside Audit & Supervisory Board Member, Taiko Pharmaceutical Co., Ltd.
Mar. 2012 Outside Audit & Supervisory Board Member, KOKUYO Co., Ltd.
Mar. 2015 Outside Audit & Supervisory Board Member, Yamaha Motor Co., Ltd.
Apr. 2015 Partner, TMI Associates
Jun. 2016 Outside Director, SMBC Nikko Securities Inc. (to present)
Jun. 2017 Outside Audit & Supervisory Board Member, IHI Corporation
Mar. 2019 Outside Corporate Auditor, Kuraray Co., Ltd. (to present)
Mar. 2021 Outside Audit & Supervisory Board Member, Kyowa Kirin Co., Ltd. (to present)
Apr. 2022 Representative, Yatsu Law and Accounting Office (to present)

Reasons for Selection

Audit & Supervisory
Board Member

The company has judged that Mr. Hiroshi Komatsu has profound knowledge and insight throughhis broad range of experiences in accounting, finance, research and development, management ofoverseas subsidiaries, corporate planning and the ethical standards, fair and equal judgment
required as an Audit & Supervisory Board member and is the right person to appropriately performthe duties as an Audit & Supervisory Board member of the Company Auditor by ensuring that theaudit and supervisory functions are fully effective across a broad range of fields.

Hiroshi Komatsu

Audit & Supervisory
Board Member
OutsideIndependent

Tomomi Yatsu
Apr. 1989 Joined Kirin Brewery Company, Limited (presently Kirin Holdings Company, Limited)
Apr. 2011 Director, General Manager of Corporate Planning,
Interfood Shareholdings Company (Vietnam)
Jan. 2013 Deputy Director, Corporate Strategy, Kirin Holdings Company, Limited
Apr. 2018 Head of Global Personnel Section, Personnel & General Affairs,
Kirin Holdings Company, Limited
Mar. 2020 General Manager, Internal Audit Dept., Kirin Holdings Company, Limited
Mar. 2022 Executive Officer, General Manager, Internal Audit Dept., Kirin Holdings Company, Limited
Mar. 2024 Outside Audit & Supervisory Board Member, Kyowa Kirin Co., Ltd. (to present)

Audit & Supervisory
Board Member
OutsideAudit & Supervisory
Board Member
OutsideHajimeKobayashi

Ms. Tomomi Yatsu is both a certified public accountant and an attorney at law. She also has animmense wealth of experience serving as outside audit & supervisory board member and outside
director of corporations. The company has deemed her to be an appropriate candidate capable ofsupervising the company and expressing audit opinions from an independent perspective throughher sophisticated knowledge and insight as an accounting and legal expert and in-depth
knowledge and insight as an audit & supervisory board member of corporations.

Audit & Supervisory
Board Member

Toru Ishikura

Apr. 1983 Joined Sony Corporation (presently Sony Group Corporation)
Sep. 1991 Joined JOHNSON COMPANY, LIMITEDJul. 2002 Executive Officer, Johnson Diversey Co. Ltd. (presently CxS Corporation)
Dec. 2004 CFO, adidas Japan K.K.
Jun. 2007 Executive Officer, Senior Vice President and CFO, Seiyu KK
May 2010 Executive Officer, SVP and CFO, Walmart Japan Holdings GK (presently Seiyu Holdings KK)
Executive Officer, SVP and CFO, Seiyu GK (presently Seiyu K.K.)
Jun. 2015 Outside Corporate Auditor, Honda Motor Co., Ltd.
Jun. 2017 Outside Director, Honda Motor Co., Ltd.
Outside Director, Hitachi High-Technologies Corporation (presently Hitachi High-Tech
Corporation)
Jun. 2019 Outside Director, SHIMIZU CORPORATION (to present)
Mar. 2022 Outside Audit & Supervisory Board Member, Kyowa Kirin Co., Ltd. (to present)
Jun. 2022 Outside Director, LIXIL Corporation (to present)

Reasons for Selection

In addition to experience in divisions related to internal audit, Mr. Hajime Kobayashi also has
extensive work experience and profound knowledge and insights on overall Group management,
including being involved in accounting and finance, corporate planning, personnel affairs and the
management of overseas subsidiaries in the Kirin Group. He was selected as a candidate for outside
Audit & Supervisory Board Member because the company has judged that he is the right person
capable of overseeing the company group widely and expressing audit opinions.

Reasons for Selection

Independent

Mayumi Tamura

Apr. 1989 Joined Kirin Brewery Company, Limited (presently Kirin Holdings Company, Limited)
Mar. 2015 General Manager, Technology Management Department, Research & Development
Division, Kirin Company, Limited (presently Kirin Holdings Company, Limited)
Apr. 2015 General Manager, Research & Development Strategy Department,
Research & Development Division, Kirin Company, Limited
Mar. 2018 Executive Officer, General Manager, Research & Development Strategy Department,
Research & Development Division, Kirin Company, Limited
Apr. 2019 Executive Officer, Vice President, Research & Development Division and General Manager,
Research & Development Strategy Department, Research & Development Division,
Kirin Holdings Company, Limited
Mar. 2020 Director of the Board, KYOWA HAKKO BIO CO. LTD.
Apr. 2020 Executive Officer, General Manager, Health Business Strategy Office,Corporate Strategy Department, Kirin Holdings Company, Limited
Apr. 2022 Executive Officer, General Manager, Health Science Business Department,
Health Science Business Division, Kirin Holdings Company, Limited
Mar. 2023 Audit & Supervisory Board Member, Kyowa Kirin Co., Ltd. (to present)
Audit & Supervisory Board Member (Full-time), Kirin Holdings Company, Limited (to present)

Reasons for Selection

Having been involved in engineering and research and development in the Kirin Group, Mr. Toru
Ishikura possesses work experience and profound knowledge and insight with regard to overall
Group management as well as experience of working in internal audit divisions. In Kirin Group
companies, he assumed the position of General Manager of the Health Business Strategy Office in
the Corporate Strategy Department in 2020 and of General Manager of the Health Science
Business Department in 2022. Having successfully fulfilled those roles, the company judges him to
be capable of appropriately performing duties in a wide range of fields as a member of thecompany’s Audit & Supervisory Board.

Reasons for Selection

Ms. Mayumi Tamura has been active as Outside Audit & Supervisory Board member and outside
director of other companies, and also has experience in engaging in support for diversity andinclusion as a board member of an incorporated NPO. Furthermore, she possesses advanced
knowledge and experience through her long-term managing roles across finance/accounting andcorporate planning at various global companies, also as former CFO with in-depth insight. The
company has deemed her to be an appropriate candidate capable of supervising the company andexpressing audit opinions from an independent perspective based on such experience, knowledge
and insight, and accordingly selected her as an outside Audit & Supervisory Board member.

Executive Officers
Managing Executive Officers

Executive Officers

Hiroshi Sonekawa

Fumihiko Kanai

Kenji Shibata, Ph.D.

Yoshiko Mori

Katsuyoshi Tsukii

Vice President, Head of Sales & Marketing Division

Responsible for ERP introduction

Director, Internal Audit Department

Vice President, Head of Development Division

Motohiko Kawaguchi

Yoshifumi Torii, Ph.D.

Shoko Itagaki

Director, Corporate Social Responsibility Management
Department

Chief Financial Officer (CFO)

Vice President, Head of Research Division

Chief People Officer (CPO)

Abdul Mullick, Ph.D.

Hiroki Takamatsu

Toshiyuki Kurata

Chief International Business Officer (CIBO)

Vice President, Head of Quality Assurance Division

Yasuo Fujii

Tomohiro Sudo

Chief Supply Chain Officer (CSCO),
Vice President, Head of Production Division

Chief Strategy Officer (CSO)

Director, Global Product Strategy Department

Atsushi Matsumoto, Ph.D.
Director, Supply Chain Management Department

Yuichi Kawasaki
Director, Product Strategy Department

Koichi Nagano
Director, Tokyo Branch Sales Office,Sales & Marketing Division

Takefumi Matsushita, Ph.D.
Director, Corporate Planning Department

Tadashi Yamaguchi
Director, Marketing Department, Sales & Marketing Division

Kyowa Kirin Co., Ltd.
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54

Financial Information
55 Eleven-Year Selected Financial Data
56 Management’s Discussion & Analysis (MD&A)

We report on the financial condition and management measures of thecompany during the fiscal year. We also perform an assessment and analysis
of corporate performance and refer to forecasts for the next fiscal year.

Adoption of International Financial Reporting Standards

Major differences between IFRS and J-GAAP

The Group has adopted the International Financial Reporting Standards (“IFRS”)
since FY2017 to enhance the international comparability of its financial reportingfor the capital market, and unify the process of the Group’s accounting. In addition, financial data for FY2016, the fiscal year prior to the adoption of IFRS, isreformulated and displayed in an IFRS format.

J-GAAPIFRS
Net sales

Revenue

Cost of sales

Cost of sales

Gross profit

Gross profit

Selling, general andadministrative expenses

Selling, general andadministrative expenses/
Research anddevelopment expenses

Adoption of “core operating profit” (IFRS)

61 Risk Factors

Major risks concerning the performance, financial condition, etc. of thecompany, which may significantly affect the decisions of investors, arereported.

The Group has adopted “core operating profit” (IFRS) as an indicator showing
recurring profitability from operating activities.
* Gross profit – Selling, general and administrative expenses – Research and development expenses +Share of profit (loss) of investments accounted for using equity method(excluding amortizationof goodwill)

Bio-Chemicals Business
Key Financial Data
Cash Flow Data
Financial Summary

Share of profit (loss) ofinvestments accounted
for using equity method

Following the conclusion of an agreement on February 5, 2019 in which Kyowa
Kirin Co., Ltd. (the “Company”) agreed to transfer 95% of the shares of its consolidated subsidiary Kyowa Hakko Bio Co., Ltd. to Kirin Holdings Company, Limited,
the Bio-Chemicals business is categorized as a discontinued operation from
FY2019. Accordingly, the consolidated financial statements for FY2018 have been
restated to reflect the change, and from FY2019, the Group has only one reportable segment: the “Pharmaceuticals business.”Core operating profit(J-GAAP)

Core operating profit(IFRS)

Amortization of goodwill(Non amortization)

Add

WEB link

Operating profit
Share of profit (loss) ofinvestments accounted
for using equity method
Ordinary profit

Other income (costs)

Extraordinary loss

Finance income (costs)

Profit before income taxes

Profit before tax

Income taxes

Income tax expense

ProfitProfit attributable toowners of parent

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CORPORATE INFORMATION

Eleven-Year Selected Financial Data
IFRS(Millions of yen)

J-GAAPIFRS(Millions of yen)(Thousands of
U.S. dollars*1)

For the Year:
Revenue*2
Gross profit*2
Selling, general and administrative expenses (including R&D expenses)*2
Core Operating Profit (J-GAAP: Operating profit)*2
Profit attributable to owners of parent
Capital expenditure and investments in intangible assets*2
Depreciation and amortization*2
R&D expenses*2

2023/122022/122021/122020/122019/122018/122017/122016/122015/12

2014/122013/122023/12¥  442,233
331,026
235,184
96,785
81,18832,07721,096
72,106¥ 398,371
311,455
229,081
86,69753,57330,984
18,47662,896¥ 352,246
264,398
203,287
65,68552,347
22,335
19,49857,679¥ 318,352
237,912
178,92259,95547,02734,782
20,46652,312¥ 305,820
226,200
170,827
59,35367,084
22,586
18,79753,511¥ 271,510
198,149
147,745
50,30654,414
13,48916,24345,659¥ 353,380
224,321
162,11357,73142,89920,71422,032
49,216¥ 347,956
214,592
163,124
39,11630,45033,27023,78452,929¥ 364,316
225,393
181,628
43,76529,774
20,03923,126
51,604¥ 333,446
205,904
169,731
36,173
15,89829,48723,88547,737¥ 340,611
212,761
160,987
51,77330,07835,183
21,592
43,682$3,118,268
2,334,129
1,658,330
682,446
572,473
226,181
148,753
508,435

Cash Flows:
Net cash provided by operating activities
Net cash provided by (used in) investing activities
Net cash provided by (used in) financing activities
Cash and cash equivalents at the end of the period¥  115,551(20,382)(32,535)
403,083¥  48,672(17,185)(29,032)
339,194¥  86,548(11,363)(28,446)
335,084¥  39,502
252,559(26,003)
287,019¥  53,655(933)(47,371)
20,762¥  56,181(39,929)(16,501)
15,867¥  64,902(45,265)(18,287)
14,685¥  66,881(49,824)(13,871)
13,076¥  66,526(57,747)(14,060)
12,784¥  19,377
16,805(37,184)
17,013¥  56,884(77,163)(12,579)
19,242$  814,774(143,719)(229,412)
2,842,216¥  611,124
1,025,942
133,237
19,301
836,418
5,974¥ 542,189
939,881
109,825
21,639762,826
5,982¥ 518,231
921,872
109,129
20,371
737,1625,752¥ 442,482
801,290
80,74917,842
698,396
5,423¥ 448,610
784,453
87,53017,185678,250
5,267¥ 385,844
741,982
80,4592,527
649,6217,242¥ 348,150
708,295
78,4092,814
616,028
7,532¥ 314,999
683,801
88,0727,000
577,036
7,465¥ 324,433
720,764
84,823
4,840
614,858
7,435¥ 283,192
719,135
85,182
4,868
605,368
7,424¥ 329,320
719,257
85,076
6,207
595,415
7,152$4,309,151
7,234,115
939,482
136,093
5,897,744—¥   151.03
1,555.81
56¥   99.68
1,419.27
51¥   97.43
1,371.90
46¥   87.56
1,300.12
44¥  124.57
1,263.16
42¥   99.40
1,186.65
35¥   78.38
1,125.56
27¥   55.65
1,054.48
25¥   54.40
1,122.80
25¥   29.05
1,105.44
25¥   54.95
1,085.17
25$    1.065
10.9700.395¥    3,150
2,276¥   3,515
2,604¥   4,240
2,687¥   3,060
1,849¥   2,594
1,674¥   2,478
1,894¥   2,227
1,515¥   2,098
1,412¥   2,321
1,094¥   1,510
1,006¥   1,256833$    22.21
16.05

540,000
537,576

540,000
537,432

540,000
537,272

540,000
537,109

540,000
538,542

576,484
547,412576,484
547,290

576,483
547,224

576,483
547,285

576,483
547,348

576,483
547,391

—
—

8.3
9.8
10.2
81.5
21.9
118,556
35.5

5.8
9.3
7.1
81.2
21.8
86,392
38.9

6.1
7.7
7.3
80.0
18.6
79,793
43.2

7.5
6.9
8.6
87.6
18.5
83,421
35.2

6.2
8.3
7.2
87.0
16.3
78,220
34.4

4.4
5.6
5.3
84.4
11.2
66,981
44.9

4.1
6.1
4.9
85.2
12.0
78,018
35.1

4.3
7.4
5.2
82.6
15.2
83,190
34.8

—
—
—
—
—
—
—

At Year-End:Total current assets
Total assets
Total current liabilities
Interest-bearing debt
EquityNumber of employees
Per Share Data:
Profit attributable to owners of parent*3
Equity attributable to owners of parent
Cash dividends(Yen)

Common Stock Price Range (Per share):High
Low
Stock Information (Thousands of shares):
Number of common stock issued
Weighted average number of common stock issued
Financial Ratios:
Return on assets (ROA)
Core operating return on assets (J-GAAP: Operating profit)*2
Return on equity attributable to owners of parent (ROE)
Ratio of equity attributable to owners of parent to total assets
Core operating margin (J-GAAP: Operating profit)*2
EBITDA*2, *4 (Millions of yen)
Payout ratio*5*1 U.S. dollar amounts are translated from Japanese yen, forconvenience only, at the rate of ¥141.82=U.S.$1, theapproximate exchange rate at December 31, 2023.

(Yen)(%, except EBITDA)

5.9
7.6
6.8
87.2
18.8
72,97450.3*2 Figures on and after 2018 represent figures in the continued operation (Pharmaceuticals)
excluding the discontinued operation (Bio-chemicals).
*3 Profit attributable to owners of parent per share is based upon the weighted average
number of shares of common stock outstanding during each year.

8.8
7.8
10.1
86.5
19.4
63,75033.7(U.S. dollars*1)(%, except EBITDA)

2.2
5.0
2.7
84.1
10.8
64,101
54.4*4 EBITDA = Profit before tax + Interest expenses + Depreciation and amortization (+ Amortization of goodwill)*5 Under J-GAAP, consolidated dividend payout ratios are calculated using net income before the deduction of amortization of goodwill that resulted
from the reverse acquisition in April 2008 (Kirin Pharma share transfer). Figures from 2021 are calculated using “Core profit” ((“Profit attributable toowners of parent” – “Other income and expenses” (excluding impact from applicable taxes)) / average number of shares during fiscal year)

Kyowa Kirin Co., Ltd.
Integrated Report 2023

CONTENTSINTRODUCTIONTOPICS FORVALUE CREATION

AT A GLANCETOPICS FORVALUE ENHANCEMENTFINANCIAL INFORMATION56

CORPORATE INFORMATIONManagement’s Discussion & Analysis
Revenue and Core Operating Profit

Figures presented in these materials have been rounded.

Subsidiaries Included in the Scope of Consolidation
The number of consolidated subsidiaries in the Kyowa Kirin Group stood at 35 asof December 31, 2023. 51% of the shares of KKI Grunenthal UK HoldCo Ltd weretransferred to Grünenthal GmbH with the formation of a joint venture with
­Grünenthal for the established medicine business in Europe. As a result, thenumber of consolidated subsidiaries decreased by four compared to the end of2022, as this company was changed from a consolidated subsidiary to an equity-­
method affiliate.

Revenue by Regional Controlling Company

The increase in revenue was the result of growth of global strategic products
mainly in North America and a rise in revenue from technology out-licensing. The
positive effect on revenue from foreign exchange was ¥18.9 billion.
Core operating profit increased as a result of higher gross profit achieved due
to gains in overseas revenue and revenue from technology out-licensing, despite
higher research and development expenses and a decrease in share of profit (loss)of investments accounted for using equity method. The positive effect on core
operating profit from foreign exchange was ¥6.5 billion.

Profit Attributable to Owners of Parent
Income(Billions of yen)2022/122023/12

Change¥398.4¥442.2¥43.9

Core Operating Profit

86.7

96.8

10.1

Profit attributable to ownersof parent

53.6

81.2

27.6

Revenue

Profit attributable to owners of parent increased as a result of an increase in otherincome due mainly to the gain on sales of share and valuation of remaining sharefollowing the shift to a joint venture structure for the established medicines business in Europe, in addition to an increase in core operating profit, and a decrease inother expenses due mainly to a decrease in impairment losses.

Core Operating Profit(Billions of yen)(Billions of yen)

442.2

96.8

100

86.7

318.4

80

352.2

ChangeJapan¥148.7¥147.0¥  (1.7)

North America

112.6

137.8

25.2

EMEA

66.9

73.3

6.5

Asia/Oceania

30.1

35.7

5.5

Others

40.1

48.4

8.3

¥398.4¥442.2¥43.9

Total consolidated revenue

Profit Attributable to Owners of Parent

398.4
400

2023/12

Notes:
1. Revenue by regional control function is classified based on consolidated revenue fromproducts of regional control functions in the One Kyowa Kirin (OKK) matrix global management structure, which combines a regional organization based on four regions of Japan,
North America, EMEA and APAC, a functional organization, and a product organization(product franchises).
2. EMEA consists of Europe, the Middle East, Africa, etc.

Revenue

500(Billions of yen)2022/1260.0(Billions of yen)
100

81.2
80

65.7

300

60

60

200

40

40

100

20

20

0

2020

2021

2022

2023

0

2020

2021

2022

2023

0

47.0

2020

52.3

53.6

2021

2022

2023

Kyowa Kirin Co., Ltd.
Integrated Report 2023

CONTENTSINTRODUCTIONTOPICS FORVALUE CREATION

AT A GLANCETOPICS FORVALUE ENHANCEMENT

Japan

North America

Revenue in Japan decreased year on year due mainly to the impact of the reductions in drug price standards implemented in April 2022 and April 2023, despite
the growth in sales of Duvroq, a treatment for renal anemia, and other products.
• Revenue from Darbepoetin Alfa Injection Syringe [KKF] decreased due to theimpact of the reductions in drug price standards and the market penetration ofrival products.
• Revenue from Duvroq, a treatment for renal anemia, has been growing steadily
since its launch in 2020.
• Revenue from G-Lasta, an agent for decreasing the incidence of febrile neutropenia, increased due to the launch of the automated injection device Bodypod in
December 2022.
• Revenue from ROMIPLATE, a treatment for chronic idiopathic thrombocytopenic
purpura, increased as a result of receiving approval for a partial change to theapproved indication from “aplastic anemia in patients who had an inadequate
response to conventional therapy” to “aplastic anemia” in September 2023, in
addition to receiving approval of its indication for treatment of patients withaplastic anemia who have had an inadequate response to conventional therapy,
in 2019, and as a result of penetrating the market.
• Revenue from Crysvita, a treatment for FGF23-related diseases, has been growing
steadily since its launch in 2019.

Revenue in North America increased year on year due to the growth of global
strategic products.
• Revenue from Crysvita, a treatment for X-linked hypophosphatemia, has been
growing steadily since its launch in 2018.
• Revenue from Poteligeo, an anticancer agent, has been growing since its launch
in 2018.
• Revenue from Nourianz (product name in Japan: NOURIAST), an antiparkinsonian
agent, has been growing since its launch in 2019.

Revenue of Major Items(Japan)(Billions of yen)
200

148.7

147.0

150

100

OthersAllelock+Patanol
Romiplate
G-Lasta
Regpara+Orkedia
Nesp+NespAG+Duvroq
Poteligeo
Crysvita

EMEA
Revenue in EMEA increased year on year due to factors such as growth of global
strategic products and proceeds from transfer of rights to Tostran, despite a drop inrevenue from the established medicines.
• Revenue from Crysvita, a treatment for X-linked hypophosphatemia, has been
growing as the number of countries where it has been released has been increasing since its launch in 2018.
• Revenue from Poteligeo, an anticancer agent, has been growing as the number ofcountries where it has been released has been increasing since its launch in 2020.

FINANCIAL INFORMATIONCORPORATE INFORMATION• Following the shift to a joint venture with Grünenthal for the established medicines business, in August 2023, revenue for 13 brands shifted from product sales
to sales royalties and license fees, which led to a decrease in revenue from established medicines such as Abstral.
• Revenue of £62.5 million (¥11.5 billion) was recorded in October 2023 due to thetransfer of the rights for Tostran, an established medicine, to ADVANZ PHARMA.

Asia/Oceania
Revenue in APAC increased year on year.
• Revenue from Crysvita, a treatment for X-linked hypophosphatemia, has been
growing particularly in Australia where sales were launched in November 2022.
• Revenue from Gran, a neutropenia treatment drug, declined due to the impactof the centralized governmental purchasing system* that started in someregions in China.
* Volume-Based Procurement (VBP) program that was introduced in 2018 for reducing healthcare costin China. Even though only 2 to 5 companies are selected as suppliers through a tender, drug prices
are dramatically dropped down.

Others
Revenue from Others increased year on year.
• Royalties revenue from AstraZeneca in relation to benralizumab increased.

Revenue of Major Items(North America, EMEA, and Asia/Oceania)

Overseas Revenue Ratio(Billions of yen)
300

(%)

246.9
209.6

OthersNourianz
Poteligeo
Crysvita

80.0

61.2
60.0

200

65.3

54.0
47.7

40.0
100

50

0

20.0

2022

2023

0

2022

2023

57

0

2020

2021

2022

2023

Kyowa Kirin Co., Ltd.
Integrated Report 2023

CONTENTSINTRODUCTION

Cash Flow
Cash and cash equivalents as of December 31, 2023 were ¥403.1 billion, an
increase of ¥63.9 billion compared to the balance of ¥339.2 billion as of­December 31, 2022.
The main contributing factors affecting cash flow during the current fiscal year
were as follows:• Net cash provided by operating activities was ¥115.6 billion, compared with net
cash provided by operating activities of ¥48.7 billion in the previous fiscal year.
Major inflows were depreciation and amortization of ¥21.1 billion, foreignexchange loss (gain) of ¥13.2 billion mainly relating to exchange differences ontranslation of foreign currency denominated deposits from consolidated subsidiaries as of December 31, 2023, and impairment losses (reversal of impairment
losses) of ¥10.8 billion, in addition to profit before tax of ¥97.2 billion. Major
outflows included gain on sales of share and valuation of remaining share of¥14.8 billion and income taxes paid of ¥8.6 billion.
• Net cash used in investing activities was ¥20.4 billion, compared with net cashused in investing activities of ¥17.2 billion in the previous fiscal year. Major outflows were purchase of property, plant and equipment of ¥17.2 billion andpurchase of intangible assets of ¥15.6 billion. Major inflows were proceeds fromsale of investments in subsidiaries resulting in change in scope of consolidation of¥7.8 billion and proceeds from redemption of bonds of subsidiaries and associates of ¥5.0 billion.

TOPICS FORVALUE CREATION

AT A GLANCETOPICS FORVALUE ENHANCEMENT• Net cash used in financing activities was ¥32.5 billion, compared with net cashused in financing activities of ¥29.0 billion in the previous fiscal year. A major
outflow was dividends paid of ¥29.0 billion.

Financial Position

FINANCIAL INFORMATION

Liabilities as of December 31, 2023, were ¥189.5 billion, an increase of ¥12.5 billion
compared to the end of the previous fiscal year, due mainly to an increase in tradeand other payables, despite a decrease in other non-current liabilities caused by adecrease in contract liabilities.

AssetsAssets as of December 31, 2023, were ¥1,025.9 billion, an increase of ¥86.1 billion
compared to the end of the previous fiscal year.
• Non-current assets increased by ¥17.1 billion compared to the end of the previous fiscal year, to ¥414.8 billion, due mainly to an increase in property, plant andequipment and an increase in goodwill due to the effect of yen depreciation inforeign exchange, in addition to an increase in investments accounted for using
equity method following the shift to a joint-venture structure for the establishedmedicines business in Europe.
• Current assets increased by ¥68.9 billion compared to the end of the previous
fiscal year, to ¥611.1 billion, due mainly to an increase in cash and cash equivalents, despite a decrease in assets held for sale.

EquityEquity as of December 31, 2023, was ¥836.4 billion, an increase of ¥73.6 billion
compared to the end of the previous fiscal year, due mainly to an increase due tothe recording of profit attributable to owners of parent as well as an increase in
exchange differences on translation of foreign operations resulting from theimpact of exchange rates, despite a decrease due to the payment of dividends, etc.
As a result, the ratio of equity attributable to owners of parent to total assets was
81.5%, an increase of 0.3 percentage points compared to the end of the previous
fiscal year.

Total Assets

Equity(Billions of yen)(Billions of yen)(Billions of yen)

(20.4)+63.9

400(32.5)

115.6

1,200

1.3

1,025.9
921.9

1,000

1,000

836.4

939.9
800

801.3

698.4

737.2

762.8

2021

2022

800
300

200

600

403.1

339.2

0

600
400
400

100

200

200
2022

OpeCF

InvCF

FinCF

Exchangedifferences

2023

58

Liabilities

Cash Flow500

CORPORATE INFORMATION

0

2020

2021

2022

2023

0

2020

2023

Kyowa Kirin Co., Ltd.
Integrated Report 2023

CONTENTSINTRODUCTIONTOPICS FORVALUE CREATION

AT A GLANCETOPICS FORVALUE ENHANCEMENTFINANCIAL INFORMATIONCORPORATE INFORMATION

59

R&D Expenses

Capital Expenditure and Investments in Intangible Assets

Per Share Data

R&D expenses for the fiscal year ended December 31, 2023 totaled ¥72.1 billion, an
increase of ¥9.2 billion from the previous fiscal year. The ratio of R&D expenses tosales for the year was 16.3%.

As a basic policy, Kyowa Kirin implements capital expenditure strategically, taking
into account the balance with depreciation. Capital expenditure and investments
in intangible assets for the fiscal year ended December 31, 2023 totaled ¥32.1
billion, a increase of ¥1.1 billion compared with the previous fiscal year. Depreciation and amortization was ¥21.1 billion, a decrease of ¥2.6 billion.

Profit attributable to owners of parent per share for the fiscal year ended­December 31, 2023 was ¥151.03, up from ¥99.68 in the previous fiscal year.
Equity attributable to owners of parent per share was ¥1,555.81, compared with
¥1,419.27 in the previous fiscal year.

R&D Expenses(Billions of yen)
80

60

72.1

52.3

57.7

Capital Expenditure and Investments in Intangible Assets

Profit Attributable to Owners of Parent per Share

(%)(Billions of yen)

(Yen)

40.0

40

200

34.8

62.9

31.0
30.0

32.1

30

151.03
150

22.3
40

16.4

16.4

15.8

16.3

20

0

2020

R&D Expenses (left scale)

2021

2022

2023

20.0

20

100

10.0

10

50

0

0

2020

2021

2022

2023

0

87.56

2020

97.43

99.68

2021

2022

2023

Ratio of R&D Expenses to Revenue (right scale)

ROE

Depreciation and Amortization

Equity Attributable to Owners of Parent per Share

(%)(Billions of yen)

(Yen)

15.0

25

2,000

20.5
10.2

20

19.5

21.1
18.5
1.500

1,300.12

1,371.90

1,419.27

2021

2022

1,555.81

10.0

6.8

7.3

15

7.1

1,000
10

5.0
500

5

0

2020

2021

2022

2023

0

2020

2021

2022

2023

0

2020

2023

Kyowa Kirin Co., Ltd.
Integrated Report 2023

CONTENTSINTRODUCTION

Outlook for FY2024
Consolidated financial earnings forecasts for fiscal 2024 are for revenue of ¥473.0
billion (up 7.0% compared to the current fiscal year), core operating profit of ¥85.0
billion (down 12.2%), profit before tax of ¥85.0 billion (down 12.6%), and profit
attributable to owners of parent of ¥63.0 billion (down 22.4%).
• Revenue is expected to increase compared to the current fiscal year given thelikelihood of growth in global strategic products centered on Crysvita and anincrease in revenue from technology outlicensing, despite the prospect of adecrease in G-Lasta due to effects of biosimilar products in Japan.
• A year-on-year decrease is forecasted for core operating profit, despite an
expected increase in gross profit attributable to higher revenue, given the prospect of higher research and development expenses and selling, general andadministrative expenses associated with having completed the acquisition of
Orchard Therapeutics plc on January 24, 2024, in addition to a substantial increase
in research and development expenses accompanying progress in development
projects particularly for KHK4083.
• A year-on-year decrease is forecasted for profit before tax due to the downturn incore operating profit.
• A year-on-year decrease is forecasted for profit attributable to owners of parent
due to the prospects of an increase in income tax expense, in addition to lower
profit before tax.

TOPICS FORVALUE CREATION

AT A GLANCETOPICS FORVALUE ENHANCEMENT• Concerning cash flows from operating activities, the Company expects a decreasein net cash provided relative to that of the current fiscal year due to the prospectsof higher income taxes paid, in addition to lower profit before tax.
• Concerning cash flows from investing activities, the Company expects an increasein net cash used relative to that of the current fiscal year given the likelihood of anincrease in cash used in purchase of property, plant and equipment and purchaseof intangible assets, in addition to cash used in the purchase of subsidiary sharesaccompanying change in scope of consolidation associated with the acquisitionof Orchard Therapeutics plc. Regarding strategic partnering, M&A and otherstrategic investments, the Company will continue to evaluate and conduct
investment using a flexible approach.
• Concerning cash flows from financing activities, the Company expects anincrease in net cash used relative to that of the current fiscal year given anticipated cash outflows for the purchase of treasury shares. As regards the purchaseof treasury shares and the sourcing of funds, we will continue to remain flexible
and act as appropriate for the economic and funding environment.
As a result of the above, cash and cash equivalents as of the end of fiscal 2024
are expected to decrease from fiscal 2023.

FINANCIAL INFORMATION60

CORPORATE INFORMATION

Profit Distribution
The Company regards the return of profits to its shareholders as one of its key
management priorities.
The basis of the Company’s policy regarding the distribution of profits is to pay
dividends stably in light of a comprehensive consideration of factors including
consolidated results and dividend payout ratio for each fiscal year, while also
increasing its retained earnings for future business development and other purposes. We plan to improve our capital efficiency with regards to the purchase oftreasury shares by taking a flexible approach while considering the share price inthe market and other factors. The Company considers it a top priority to useinternal reserve funds for investments for future growth (R&D investments, strategic investments and capital expenditures) in order to achieve sustainable growthfrom fiscal 2025 and maximize corporate value.
As the dividend policy, the Company set its target dividend payout ratio basedon core EPS at 40% in the FY2021–2025 Medium Term Business Plan. The Company
aims to ensure a stable and sustained increase in the level of dividend payment(continuous increase of dividend payments) in line with medium- to long-term
growth in profits.
In accordance with the above-mentioned policy, the Company paid an annual
dividend from surplus of ¥56.00 per share for FY2023, an increase of ¥5.00 from theprevious fiscal year and the seventh consecutive year of increase.

Outlook for FY2024(Billions of yen)2023/122024/12(Outlook)(Yen)

Year-on-yearchange2023/122024/12(Outlook)Calculation method2023/122024/12(Outlook)

Dividend per share (Second quarter-end)

27

29

Revenue

442.2

473.0

30.8

ROE

10.2%

7.6%

Profit / Average beginning andending equity

Core operating Profit

96.8

85.0

(11.8)

Revenue growth ratio

11.6%

10.4%

Annual average growth rate withfiscal 2020 as base year

Dividend per share (Fiscal year-end)

29

29

Profit before tax

97.2

85.0

(12.2)

R&D expense ratio

16.3%

21.1%

Research and development
expenses / Revenue

Dividend per share (Annual)

56

58

Profit Attributable to Owners of Parent

81.2

63.0

(18.2)

Core operating profit ratio

21.9%

18.0%

Core operating profit / Revenue

Dividend payout ratio*

35.5%

47.6%

* Note: These forecasts assume average exchange rates of ¥140/US$, ¥180/British pound and ¥155/€* The dividend payout ratio is based on core EPS (calculated as an indicator showing recurring
profitability by dividing core profit (determined by subtracting “other income,”“other expenses” andthe related “income tax expense” from “profit”) by the average number of shares during the period).

Kyowa Kirin Co., Ltd.
Integrated Report 2023

CONTENTSINTRODUCTION

AT A GLANCETOPICS FORVALUE CREATIONTOPICS FORVALUE ENHANCEMENTFINANCIAL INFORMATIONCORPORATE INFORMATION

61

Risk Factors
This section describes principal risks identified by the Kyowa Kirin Group as of December 31, 2023. However, the Group may face other unforeseen risks caused by changes
in internal and external conditions, and risks not described here may have a negative impact on the Group’s business performance and financial position.
The Group defines risks as factors that could have an uncertain impact on business targets, including both threats and opportunities.

Risks related to maximizing the value of global strategic products
Details of risks and expected main impacts
The Group is working to maximize the value of two and other drugs that have been positioned
as global strategic products – Crysvita, a treatment for X-linked hypophosphatemia andPoteligeo, an anticancer agent. We launched our own marketing for Crysvita in North America
in April 2023. However, we need to continue monitoring whether we can increase sales andprofit through market expansion. Moreover, regarding risks of global strategic products as awhole, the following risks may prevent the Group from attaining its business targets: delays tosales area expansion caused by setbacks in market launch preparations; slow progress withmarket penetration due to difficulties in identifying potential patients; sharply lower-than-­expected sales due to a shortfall in projected product prices in new markets; and impediments
to stable supplies caused by quality issues, manufacturing problems and other issues.

Key mitigation measuresaspects so as to securely deliver them to patients. Furthermore, in price setting, the Groupconsiders the impact on its business so that it can secure appropriate revenues to continuously creating innovative drugs, while complying with each country’s systems.

Risks related to production and stable supply
Details of risks and expected main impacts
In cases where detailed, accurate demand forecasts in various regions are impossible, particularly where market supply and demand fluctuates significantly due to the supply difficulties ofother companies; where it is impossible to maintain supply capacity due to complianceviolations in the supply chains, such as the Group’s proprietary plants, contract manufacturers,
or other suppliers of raw materials, or disaster damage, stable supplies of the Group’s products
could be impeded, resulting in factors such as delays in drug launch schedules or limited
shipments of product that could erode trust in Kyowa Kirin as a pharmaceutical company or
depress revenues, among other things.

In preparation for maximizing the value of global strategic products, we are moving forwardwith measures for penetrating markets and expanding our business regions, centered on
Europe and the U.S. In addition to a global management system that facilitates seamlesscooperation between functions (divisions) and regions (affiliates) on a global level, the Group
has appointed personnel to take responsibility for each global strategic product. This person
leads a cross-function/region team that works together to draft and execute strategies tomaximize the value of each product. We have started our own marketing of Crysvita in North
America where we are well-prepared and continue to identify patients who require treatment,enhance communication with them, monitor field activities, and increase the level of fieldteams engaged in such activities. Regarding issues with quality and manufacturing, key
mitigation measures are outlined in the “Risks related to product quality” and “Risks related to
production and stable supply.”

The Group is implementing sales and operations planning (S&OP) to increase the accuracy ofdemand forecasting by rapidly identifying product sales and trend in needs responding tochanges in external environments, and to achieve a supply-demand balance and enable quick
adjustments in line with business plans. The Group formulates a BCP, reviews a safety stock
holding policy in accordance with risks, implements self-inspection required in the industry,
sets and monitors objective stable supply indicators, and visualizes demand using a supply-­demand planning system. In addition, the Group is expanding its network of contractors,
investing in proprietary plants, rolling out digital technology to enhance manufacturing
operational efficiency, and increasing headcount and upgrading training systems in the
production and quality assurance divisions.

Risks related to healthcare cost-control policies

Risks related to human resources

Details of risks and expected main impacts
The trend toward tighter control of healthcare costs is increasing in Japan and elsewhere.
Efforts to reform healthcare systems in various countries involve reducing prices of drugs andencouraging wider use of generic drugs. These trends may have a negative impact on theGroup’s business performance and financial position. In this context, while being innovative
and also adequate for unmet medical needs is important to the successful reception fromstakeholders, delays to the development of further practical, groundbreaking new drugs may
undermine the Group’s growth potential and profitability.

Key mitigation measures
The Group closely monitors healthcare policy trends in each country, while also strategicallyexamining measures to evaluate the value of its life-changing pharmaceuticals from various

Key mitigation measures

Details of risks and expected main impacts
The Group is working to embed its global management system to encourage individuals fromdiverse backgrounds to demonstrate their abilities and engage in business activities in Japanand overseas. However, if the Company is unable to develop and hire personnel who will be
responsible for the global management system, this may hinder the continuation of its
business activities or sustainable growth.

Key mitigation measures
The Group believes that people are the source of innovation. To maximize the abilities of eachof its employees with diverse backgrounds and develop person and organization that challenge to innovate and continuously create new value, the Group promotes measures for theachievement of “Global Talent Management Basics for 2021–2025” created by the Human

Resources Department to visualize human resources function’s ideal state in 2025. Among
measures taken thus far to build a global common human resources platform for promoting
the One Kyowa Kirin system, the Group has focused on, specifically, identifying global key
positions and their talent requirements, developing global common grading, formulating
leadership principles, introducing our global human resource system (HRIS) and expand its
functions. Concurrently, to strengthen the management system on a global basis, the Grouphas created succession planning for each of its global key positions and nominated next-­
generation leadership candidates irrespective of race, nationality, gender, or age. In addition,
to strengthen the pipeline of human resources, the Group formulates individual training
programs for each successor (Global Succession Plan), and implements human resource
development systematically by carrying out short-term assignments on a global basis (Global
Exchange Program), etc. Talent review will be organized by Global HR Business Partners beyond
the framework of regions, aiming to assign the right person in the right place at a global level.
Through the employees’ attitude survey and (Global Engagement And Motivation Survey)
and simple surveys related to corporate culture reform, the Group monitors the extent towhich the above-mentioned initiatives are gaining acceptance and taking root. At the
Human Resource Development Committee in which not only the officer in charge of humanresources but also officers in charge of other functions participate as members, each of thesemeasures implemented by the Human Resources Department is discussed to allow them to
be more effective.

Risks related to R&D
Details of risks and expected main impacts
In its R&D, the Group pursues the ongoing creation of groundbreaking pharmaceuticalproducts and has established the following strategies centered on technology, disease, andopen innovation. (i) In addition to its ongoing quest to drive advances in antibody technology, the Group will build a platform for creating breakthrough drugs by making full use ofdiverse modalities. (ii) The Group will continue to provide “Only-one value drugs” to address
diseases that currently have no effective treatment while taking advantage of diseasescience that generated global strategic products such as Crysvita and Poteligeo to date. (iii)
The Group will continue to proactively incorporate external innovation through advanced
open innovation activities, fusing collaborative research activities with academia, startups,
and other partners (information gathering in the San Diego area, etc.) with early access to
information by means of venture capital fund investments. However, in the process ofdeveloping new drugs over long periods of time, there may be cases where R&D has to beabandoned; for example, if expected efficacy is not confirmed or for safety and otherreasons, which may prevent the Group from expanding its drug pipeline, undermining
growth potential and profitability.

Kyowa Kirin Co., Ltd.
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CONTENTSINTRODUCTION

Key mitigation measures
The Group is actively stepping up investments in R&D (aiming for an R&D expense ratio of
18–20%) to strengthen the pipeline of new drugs that will lead the next generation, such as
global candidates. To complement proprietary research, the Group is also focusing on open
innovation activities involving partners from across industry, government, and academia,
including active strategic partnering (in-licensing, tie-ups, etc.) to acquire platform technologies and pipeline assets. For instance, since 2018, the Group has been extending its R&D
alliance with InveniAI LLC of the United States providing AI and machine learning applications,
identifying, assessing, and optimizing novel drug discovery targets that complement theGroup’s proprietary next-generation antibody technology. In addition, the Group is promoting
digital transformation of R&D alliance by accessing the AI technology platform owned by
InveniAI. Moreover, through investing in a venture capital fund, in 2022 the Group entered intoa research collaboration with LUCA Science Inc., which has a proprietary technology to isolate
high functional mitochondria. The collaboration allows for the Group to create innovative
therapeutic options based on mitochondrial drug discovery. To further strengthen access to
cutting-edge drug discovery technology owned by academia, the Group has started anorganizational alliance with School of Life Science and Technology, Tokyo Institute of Technology this year for the development of drug discovery technology. In addition, to take ininnovation on a global basis, the Company continues to strengthen alliance with La Jolla
Institute for Immunology, a world-leading research institute, through Kyowa Kirin North
America’s research institute, and promote CVC (Corporate Venture Capital) activities. In October 2023, the Company entered into an acquisition agreement with England-based Orchard
Therapeutics plc, specializing in hematopoietic stem cell gene therapy. Through the acquisition, we will significantly strengthen our research and development capability for continuing
to create life-changing value by combining our drug discovery technology and experience
with its hematopoietic stem cell gene therapy technology.

Risks related to parent and Group company management
Details of risks and expected main impacts
To achieve its management goals as a Japan-based global pharmaceutical company, in
accordance with the Basic Policy on the Internal Control System, the Group has been working
to enhance its governance by establishing an appropriate system to secure its compliance, risk
management, and the appropriateness of financial reports, as well as reporting their operations to the Board of Directors. In the event that these measures are not fully effective, emerging risks could result in restrictions or suspensions of production, sales and other businessactivities, and the loss of trust as a pharmaceutical company.

AT A GLANCETOPICS FORVALUE CREATIONTOPICS FORVALUE ENHANCEMENT

the three-line model advocated by the Institute of Internal Auditors, and has secured a system
to make appropriate responses to risks. Compliance is provided in “Risks related to compliance”
and the appropriateness of financial reports is in “IV. Information about Reporting Company, 4Corporate governance” respectively.

Risks related to product quality
Details of risks and expected main impacts
Pharmaceutical manufacturing requires facilities (hard assets) and procedures and people (softassets) that are compatible with good manufacturing practice (GMP). Should a GMP inspection
by a national authority or an internal audit find a serious GMP issue, the regulatory authority
may issue instructions for production or shipments to be suspended. In addition, if for any
reason there are any concerns about the safety or quality of a product with regard to raw
materials or manufacturing processes used to make the product, these may give rise to asuspension of shipments or product recall.

Key mitigation measures
The Group’s quality assurance functions are centered on the Global QA Head, who reports
directly to the President and collects and shares information about quality assurance activities
in each region for prompt decision making. Specifically, the Global Quality Assurance Committee, regular and ad hoc Global Product Council, and other quality assurance bodies discuss
critical quality-related issues reported by regional control functions, evaluate quality performance at newly selected manufacturing sites, regularly assess product quality, review theactivities of global taskforces established to address specific issues, and monitor issues identified in audits and progress with related response measures. The Group has also established a
global, independent specialist audit unit to reinforce product quality audits within the Groupand at contractors. In addition, the Group has completed introducing an electronic Quality
Management System to appropriately manage and utilize large volumes of quality assurance
information on a global level and to drive continuous improvements in processes and reliability. With eQMS, key quality management processes (education and training, document
management, deviation, complaints, corrective and preventative actions, modifications,change control, audits, manufacturing site management, etc.) are all managed electronically.
Quality assurance divisions and safety divisions always work closely and have established asystem to prevent health damage to patients by promptly evaluating impacts on patients if
quality concerns arise and always consider the effect of quality in product safety monitoring.

Risks related to the management of suppliers and contractors
Details of risks and expected main impacts

Key mitigation measures
Risk management aims to achieve group-wide risk management that can anticipate the future
and take preventative measures. To this end, the Group has introduced an IT tool to uniformly
manage group-wide risks, and stages ongoing crisis and BCP drills not only linking its head
office with each region but also across regions in Japan and overseas, and deliberates onmaterial issues (materiality) that are both risks the Group needs to address over the mediumto long-term as well as opportunities. Through these actions, the Group is working to heighten
its ability to respond to new and potential risks. Principal risks of the Group as well as regions
are monitored by the Group’s CSR Committee and each region’s CSR Committee and theirdetails are reported to the respective board of directors. Furthermore, the Group conforms to

The Group enters into alliances with other companies, in the form of joint development, jointcommercialization, technology partnerships, and establishment of joint ventures, and it also
outsources operations related to the supply of raw materials, production, logistics, andmarketing for pharmaceuticals to other domestic and overseas suppliers. However, if thealliances and outsourcing contracts fail to deliver the expected results or are dissolved due toissues related to human rights, legal compliance, the environment, information security at
suppliers, or if there are quality issues with contracted deliverables, the Group could facedifficulty securing stable supplies of the Company’s products or issues in logistics and sales,
which may erode trust in Kyowa Kirin as a pharmaceutical company, lower revenues, or lead todelays in new drug applications.

FINANCIAL INFORMATIONCORPORATE INFORMATION

62

Key mitigation measures
The Group is seeking to conduct sustainable procurement in line with the Kyowa Kirin Group
Procurement Policy, which states its commitment to pursue sustainable procurement together
with suppliers to ensure stable supplies of high-quality products. To ensure that suppliers arefamiliar with the Group’s initiatives for sustainable procurement, the Group holds briefing
webinar for suppliers periodically. In addition, the Supplier Code of Conduct sums up theseven areas where the Group calls for understanding and cooperation from suppliers: relationships with society, relationships with employees, compliance with rules, respect for humanrights, environmental preservation, information management, and risk management. In
dealing with suppliers, we have added a clause of compliance with the Supplier Code of
Conduct to our contracts, and the Group conducts questionnaires to confirm compliance with
the Supplier Code of Conduct, publishing the results. The Group also obtains risk and credit
background data from external organizations and conducts supplier assessments based on
objective information. The Group obtains similar information in the course of transactions asneeded, and confirms with a supplier when there is any cause for concern. In addition, theGroup promptly shares the risk information it obtained with relevant divisions and works
together to mitigate risk, including requesting corrective action from suppliers or consideringchanging suppliers, as needed. Through the procurement functions and systems establishedin each region, the Group takes measures to reduce risks and monitors the status. Based on
Kyowa Kirin Group Human Rights Policy established in December 2022, the Group also
promotes human rights due diligence initiatives.

Risks related to information security
Details of risks and expected main impacts
As the Group utilizes a variety of networks and information systems, the Group may experiencesystem outages or external leaks of confidential information in the event of unauthorized
system access or cyberattacks. A cyberattack on a supplier could result in damages such as theleakage of confidential information of the Group or personal data, suspension of businessactivities, or damage to the brand. The move to homeworking is improving productivity, but
the number of employees using home communication environments or working alone isrising, which increases the risk of surveillance committed through networks, cyberattacks,
email errors, and loss of personal computers that may lead to information leaks. In addition, as
cloud-based services are used more frequently, a security accident (including inaccessibility tosuch a service) occurring at the side of an outside service provider may directly affect theGroup’s business contingency.

Key mitigation measures
The Group is taking steps to upgrade information security, including technical measures toguard against cybersecurity threats that are becoming more diverse and more sophisticatedeach year, as well as developing playbooks that include information such as the recommended initial response flow and procedural steps in the event of a cyber incident, to establish the system to respond to incidents. Moreover, by periodically conducting an outside
evaluation driven by a standard framework for the security industry, the Group continuously
improve a responsive plan formulated based on an objective risk evaluation. The Group is also
taking measures to mitigate various risks, such as monitoring its business partners to verify
their response to the security measures. In addition, to be better prepared to mount a rapid
response and minimize damage in the event of an incident, the Group is continuouslyKyowa Kirin Co., Ltd.
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CONTENTSINTRODUCTION

conducting crisis drills in each region to deal with ransomware and other cyberattacks. The
Group is also educating employees to raise their level of information security by conducting
educational seminars periodically and targeted e-mail attack drills, and raising awareness bydisseminating information and precautions on preventing infection from computer viruses inaccordance with the characteristics of the latest attack methods, points of attention, etc.,
through seminars for employees, a dedicated cybersecurity website, etc. BCP system and drills
simulating limited use of cloud services are also being organized.

Risks related to compliance
Details of risks and expected main impacts
The Group is required to comply with a range of laws and regulations governing pharmaceutical R&D, manufacturing, sales, imports, and exports. In addition, in exchange with patientgroups for patient-centered activities and the promotion of pharmaceuticals, in addition to thelaws and regulations of each country, there are voluntary codes in the industry, and pharmaceutical companies are strongly requested to comply with them. Failure to comply with theselaws, regulations and voluntary codes could result in sanctions that delay or suspend thedevelopment of new drugs, or restrict or suspend production, sales, and other businessactivities, which may erode trust in Kyowa Kirin as a pharmaceutical company.

Key mitigation measures
The Group believes that compliance is not only legal compliance, but also involves promptly
sensing and properly understanding the needs of society and acting ethically. We havestipulated the overall behavior expected of our officers and employees in the Kyowa Kirin
Group Code of Conduct. The Company has established a system to comply with various laws
and regulations and voluntary codes, and conducts ongoing education and training. The
status of compliance and the progress of measures to address material issues are discussed ateach regional CSR Committee meeting and at the Group CSR Committee meeting, both ofwhich are held periodically, and ongoing improvement is promoted. In addition, the Group
has set up a whistleblowing hotline to prevent, quickly detect, and rectify acts that violate theCode of Conduct or significantly damage the brand value of the Group. Furthermore, theGroup conducts an annual employee compliance awareness survey to identify potential risks,
while working to mitigate risks in the early stages by confirming the facts of survey responses
and responding accordingly. Survey results are also reported to the CSR Committee and theBoard of Directors. The Group compliance enhancement project that started in 2021 is
improving a framework to monitor the status of efforts by each department in charge basedon the various Kyowa Kirin Group Policies that supplement the Code of Conduct as well as thelaws and regulations that a global pharmaceutical company must comply with, and a framework of company-wide monitoring of the compliance program of each region, including the
global head office. Based on the monitoring results, the Group implements measures for
improvement accordingly, further raising its compliance level.

AT A GLANCETOPICS FORVALUE CREATIONTOPICS FORVALUE ENHANCEMENT

Risks related to natural disasters
Details of risks and expected main impacts
Natural disasters such as earthquakes and typhoons that may occur in various locations could
lead to the closure of the Group’s head offices, plants, research laboratories, and businessoffices or halt business activities, potentially impacting progress in drug discovery research andclinical development, the stable supply of products, the collection of safety information, andthe provision of product information, which may have a negative impact on the Group’sbusiness performance and financial position.

Key mitigation measures
The Group has developed a coordinated disaster prevention plan with its business sites toensure the safety of employees and their families in the event of a disaster. Based on the plan,
the Group regularly conducts safety confirmation drills and safety equipment upgrades/
checks. The Group has also developed a BCP to continue supplies, monitoring, and providing
information of pharmaceuticals in the event of difficulty ensuring the continuity of normal
business activities. The Group conducts BCP drills simulating a range of scenarios, including
super typhoons and a massive earthquake directly under the Tokyo metropolitan area. We areworking to identify issues through such drills and continuously improve our BCP. Based on the
global, all-hazard BCP guidelines established in 2021, the Group is working to enhance thebusiness continuity framework in each region to prepare for various events. For example, theGroup is planning to construct a new warehouse building with earthquake-proof construction
at its Takasaki Plant (construction started in October 2023, operation start scheduled forJanuary 2026).

Risks related to climate change
Details of risks and expected main impacts
The occurrence of floods caused by extreme weather brought about by climate change could
affect all of our business activities, including the stable supply of our products and research
activities. Furthermore, in the future, the Group’s brand value may decline if additional costs
are incurred due to the introduction of carbon taxes or measures to comply with tighter
environmental regulations, or if greenhouse gas reduction targets cannot be achieved.

FINANCIAL INFORMATIONCORPORATE INFORMATION

63

Key mitigation measures
In addition to the impact on business activities, the Group considers the response to climatechange (prevention of global warming) to be critical to bringing about a sustainable society.
The Group has created a roadmap for reducing greenhouse gas emissions over the medium- tolong-term, and is moving forward with an array of initiatives across the Group. In the medium
term, the Group is accelerating the reduction of emissions of greenhouse gases by focusing onenergy-saving measures and expanding the use of renewable energy. From 2020, the Group has
introduced RE100- certified renewable energy to its Takasaki Plant and Fuji Site, Ube Plant andHead Office, switching 100% of their purchased electricity to electricity that emits no greenhouse gases. In March 2023, Ube Plant started operation of a large-scale solar power generation
system (1.47 MW) based on an onsite PPA (Power Purchase Agreement) model. In addition, thenew office building that was completed in April 2023 adopted renewable energy upon
reducing primary energy through energy conservation measures and received a ZEB (net Zero
Energy Building) certificate for the first time among the Group and the Kirin group, which is
given to a building aimed at net energy consumption of zero.
The construction of a new quality assurance-related multipurpose facility (Q-TOWER) wascompleted in December 2022 at Takasaki Plant. In constructing Q-TOWER, we reduced­environmental impact by using a precast-prestressed concrete method in which concrete
components are prepared in advance at the plant and assembled on site.
On the other hand, Kyowa Kirin China Pharmaceutical Co., Ltd. installed a solar power
generation system when building a new warehouse, promoting the introduction of renewable energy.
With regard to GHG emissions under Scope 3 from the Group’s value chain, we haveclassified 15 categories and calculated them in accordance with the guideline of the Ministryof the Environment conformed with the GHG Protocol. Then we have formulated an initial
hypothesis of reduction measures and an initial roadmap plan. Going forward, we will develop
measures to reduce GHG by setting a medium- to long-term target for GHG reductions under
Scope 3 and working together with contract manufacturers and suppliers. Among environmental performance data, we see data of climate change and the amount of water consumption as significant indicators so that we have received a third party assurance to secure thedata reliability.
The Group has endorsed the recommendations of the Task Force on Climate-related
Financial Disclosures (TCFD), and has determined the risks and opportunities that climatechange poses to its businesses and their impacts. Following the recommendations of the
TCFD, the Company discloses information on the following four items: governance, strategy,
risk management, and metrics and targets.

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64

Corporate Data
Corporate Data (As of December 31, 2023)
Kyowa Kirin Co., Ltd.

Principal Plants

R&D Network

Head Office

Date of Foundation

Japan

Japan

1-9-2, Otemachi, Chiyoda-ku, Tokyo 100-0004, Japan
Tel: 81-3-5205-7200
Fax: 81-3-5205-7182
URL: https://www.kyowakirin.com/

July 1, 1949

Takasaki Plant (Takasaki City, Gunma)Ube Plant (Ube City, Yamaguchi)

Tokyo Research Park (Machida City, Tokyo)
Fuji Research Park (Sunto-gun, Shizuoka)
CMC R&D Center (Sunto-gun, Shizuoka)
Bio Process Research and Development Laboratories(Takasaki City, Gunma)

Paid-in Capital

Overseas¥26,745 million

Kyowa Kirin China Pharmaceutical Co., Ltd.
Principal Plants

Number of Employees

Overseas

Consolidated: 5,974

Kyowa Kirin, Inc.
Kyowa Kirin China Pharmaceutical Co., Ltd.
Kyowa Kirin Korea Co., Ltd.

Network (As of December 31, 2023)

Name of Company

Japan
Kyowa Kirin Plus Co., Ltd.
Kyowa Kirin Frontier Co., Ltd.
North America
Kyowa Kirin USA Holdings, Inc.
BioWa, Inc.
Kyowa Kirin, Inc.
Kyowa Kirin Canada, Inc.
2 other companies
EMEA
Kyowa Kirin International plc.
17 other companies

Proportion of
Voting Rights Held

Share Capital(1,000)

Proportion of
Voting Rights Held

Share Capital(1,000)

Kyowa Kirin Asia Pacific Pte. Ltd.

100%

SGD 123,045

Kyowa Kirin China Pharmaceutical Co., Ltd.
Kyowa Kirin Korea Co., Ltd.
Kyowa Kirin (Taiwan) Co., Ltd.
Kyowa Kirin (Hong Kong) Co., Ltd.
4 other companies

100%
100%
100%
100%

US$ 29,800
KRW 2,200,000
TW$ 262,450
HK$ 6,000

50.0%
49.0%

¥100,000£0.1

Name of Company

Principal Business

Principal Business

APAC
100%
100%

100%
100%
100%
100%

100%

¥100,000¥100,000

US$ 76,300
US$ 10,000
US$ 0.2
CA$ 0.2£13,849

Insurance, wholesale and retail
Manufacturing and sales of pharmaceuticals

Supervision and management of specific subsidiaries (U.S.A.)
Out-licensing of antibody technology (U.S.A.)
R&D and sales of pharmaceuticals (U.S.A.)
Sales of pharmaceuticals (Canada)Supervision and management of specific subsidiaries (U.K.)

Equity-method affiliate
FUJIFILM KYOWA KIRIN BIOLOGICS Co., Ltd.
KKI Grunenthal UK HoldCo Ltd
10 other companies

Supervision and management of specific subsidiaries and sales ofpharmaceuticals (Singapore)
Manufacturing and sales of pharmaceuticals (China)
Sales of pharmaceuticals (Korea)
Sales of pharmaceuticals (Taiwan)
Sales of pharmaceuticals (Hong Kong)

Development, manufacturing and sales of biosimilar pharmaceuticals
Supervision and management of specific subsidiaries (U.K.)

Kyowa Kirin Co., Ltd.
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CONTENTSINTRODUCTION

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65

Investor Information (As of December 31, 2023)
Stock Listing

Principal Shareholders

Tokyo

Number of Shares Held(Thousands)

Percentage of Total
Shares Issued (%)

288,819
58,46225,600
8,936
5,844
5,210
5,142
3,473
3,382
2,920

53.72
10.87
4.76
1.66
1.09
0.97
0.96
0.65
0.63
0.54

Kirin Holdings Company, Limited
The Master Trust Bank of Japan, Ltd. (Trust Account)
Custody Bank of Japan, Ltd. (Trust Account)
STATE STREET BANK AND TRUST COMPANY 505223
STATE STREET BANK WEST CLIENT – TREATY 505234
SMBC Nikko Securities Inc.
JP Morgan Securities Co., Ltd.
STATE STREET BANK AND TRUST COMPANY 505025
JP Morgan Chase Bank 385781
The Dai-ichi Life Insurance Company, Limited

Securities Code
4151

Transfer Agent of Common Stock
Sumitomo Mitsui Trust Bank, Limited
1-4-1, Marunouchi, Chiyoda-ku, Tokyo
100-8233, Japan
http://www.smtb.jp/personal/agency/index.html

Number of Shares of Common Stock
Authorized: 987,900,000
Issued: 540,000,000

Stock Price and Trading Volume
Stock Price (Yen)

Trading Volume (Millions of shares)

4,500

Number of Shareholders

4,000

39,131

3,500

Shareholding by Type of Investor (Number)

3,000

Individuals

Treasury stock

6.99% (37,690)

0.44% (1)Overseascompanies

16.70% (782)Securities
companies

18.12% (65)

2,000

100

1,500

75

1,000

50

500

25

0

3.12% (60)Financial
institutions

2,500

2019
2020
2021
2022
2023
1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12

Other companies

54.63% (533)

Total Shareholder Return (TSR)
Kyowa Kirin Co., Ltd.
TOPIX Total Return Index

Past 4 years

Past 3 years

Past 2 years

Past 1 year

Current year

125.9%
118.1%

139.6%
126.8%

157.3%
143.0%

154.2%
139.5%

125.6%
178.9%

0https://www.kyowakirin.com