Chugai Pharmaceutical : Annual report 2021

Annual Report 2021

Fiscal year ended December 31, 2021

Introduction

Chugai's Business Model

Unique

science and technologies

Focus on

innovation

Strategic

alliance with

Roche

	Two Revenue Bases
Products from	Products in-licensed
Chugai research	from Roche

Specialized in highly innovative drug		Reins in R&D costs and enables
discovery and addressing unmet
	efficient development
medical needs

Out-licensingtoRoche and	Exclusive domestic sales
global market development

Drives growth		Securesstable revenues

	1			2
Global growth	A well-stocked pipeline

3

Strong domestic presence in therapeutic antibodies

Performance in 2021That EmbodiesThis Business Model

1 Global growth

Global sales of products from Chugai research1 (Millions of CHF)

2021 8,047

2015

2009

Chugai achieved rapid global growth by delivering a constant stream of products from Chugai research via the Roche network to patients around the world. In 2021, there was steady market penetration by Hemlibra and increased demand for Actemra, mainly overseas, to treat patients with severe COVID-19, such that global sales of these products increased and drove growth by the Roche Group. This global growth creates a positive cycle whereby the Roche Group is able to increase investment of resources and Chugai is able to in-license additional enhanced products from Roche.

2 A well-stocked pipeline

Number of pipeline projects

	Products from Chugai research		Products in-licensed from Roche	54
2021
11						43
2020								54
15				39
2019							45
10				35

Note: Products from Chugai research in 2020 and 2021 included products in-licensed from a third party (one in 2020, one in 2021).

3 Strong domestic presence in therapeutic antibodies

Sales share in the Japanese therapeutic antibody market

Development of products from Chugai research and of products in-licensed from Roche is progressing steadily, thanks to our focused allocation of business resources in innovative drug discovery and our highly efficient development activities, including the collaboration with Roche. This has allowed us to maintain a robust pipeline in terms of both quality and quantity. In 2021, we started clinical development on two in-house projects, including our first mid-size molecule drug LUNA18, and we also in-licensed three projects from Roche.

Chugai has established a defined presence in Japan through its innovative products and the delivery of

(excluding Ronapreve)2

22.9%

Top Share

solutions for healthcare professionals and medical facilities (marketing, medical affairs, drug safety). In 2021, we maintained our top position in Japan for sales share in the Japanese therapeutic antibody market, sales share in oncology,2 satisfaction ranking in oncology based on healthcare professionals' assessments,3 and adequacy ranking for provision of safety information.4

1. Actemra (approved overseas in 2009), Alecensa (approved overseas in 2015), Hemlibra (approved overseas in 2017), and Enspryng (approved overseas in 2020)
2. Copyright © 2022 IQVIA. Source: JPM 2021 (calendar year). Reprinted with permission. The scope of the market is defined by Chugai.
3. Source: Multimedia White Paper on Physicians _ Autumn 2021 published by MCI, based on the survey of oncologists "owned media ranking (2nd), non-pharma medical websites ranking (1st)"
4. Source: Total results of all respondents of "INTAGE Healthcare Inc., 2021 questionnaire about safety information needs"

Annual Report 2021 1

Themes of the Year (January to December 2021)

In February 2021, we announced TOP I 2030*, a 10-year growth strategy designed to realize our goal of becoming a top innovator by the year 2030.

In 2021, the first year of TOP I 2030, we progressed steadily with its individual strategies. As well as achieving marked progress in research and development, we were able to post record results in financial terms.

• TOP expresses our aspiration to become "the world's top innovator, not just in Japan." The "I" has two meanings: in addition to "innovator," it also expresses that each and every member of the Chugai Group plays an important role in our efforts to realize TOP I 2030.

R&D Results	Financial Performance
Added to pipeline	Revenues
8 projects	¥ 999.8billion
	(+27.1% YoY)
Number of academic
papers and presentations	Operating profit (Core)
on research findings at
¥ 434.1billion
scientific conferences
75	(+43.4% YoY)
New products launched	Market capitalization
(As of the end of March 2022)
and new indications
¥ 6.9trillion
10

Activity Themes

R&D	• Addition to pipeline of LUNA18 in the new modality of mid-size molecule drugs

Pharmaceutical Technology and Solutions

• Out-licensingto Roche at the phase I stage of SOF10, an in-house developed therapeutic antibody that is expected to be effective in types of cancer resistant to immunotherapy
• Approval of Ronapreve for additional indication as a preventive treatment of symptomatic COVID-19, addition of subcutaneous injection as administration method
• Approval for expansion of Actemra indications to include COVID-19-associated pneumonia (EU, Japan; January 2022)
• Approval and market launch of Polivy and Evrysdi
• Service launch of FoundationOne Liquid CDx, a cancer gene panel test using blood samples
• Construction of new facilities at the Fujieda and Ukima plants to enhance the supply system for small and mid-size molecules and biological active pharmaceutical ingredients (APIs)
• Start of rollout of eConsent, which uses images, videos, etc., to explain the content of clinical studies to patients in an easily accessible manner
• Launch of new customer database and information platform

Foundation for Growth • Acceleration of digital transformation (DX) activities, continuation of listing as a DX Stock in 2021

• Setting of Mid-Term Environmental Goals 2030. Setting of associated goal of zero CO2 emissions for 2050
• Continuation of listing in DJSI World, an index of top global companies for environmental, social, and governance (ESG) investment (2nd place globally in the Pharmaceutical Sector)

2 CHUGAI PHARMACEUTICAL CO., LTD.

Contents

4 Vision

34 Progress

70 Governance

6 History to Date and Envisioned Future for 2030

8 Top Innovator in

the Healthcare Industry

14 Message from the CEO

18 Initiatives

1. Value Creation Model

1. Overview of TOP I 2030

24 Capital Investment under TOP I 2030

26 Material Issues and TOP I 2030

1. STORY 1
   Improving Patient Value through Stable Supply
2. STORY 2
   Improving Patient Value through Consulting Initiatives
3. Executive Officers

32 Sustainability Initiatives and Challenges

1. Overview of 2021 and Strategic Policies for 2022
2. Overview of Progress Reports
3. Progress in R&D

1. Progress in Open Innovation
2. Progress in DX
3. Strategy Implementation 1 Drug Discovery

44 Focus

Mid-Size Molecule Drug Discovery

1. STORY 3
   Improving Patient Value through Mid-Size Molecule Research
2. Strategy Implementation 2

Development

1. STORY 4
   Improving Patient Value through Human Prediction Research
2. Strategy Implementation 3

Pharmaceutical Technology

52 Strategy Implementation 4 Value Delivery

54 Strategy Implementation 5 Foundation for Growth

58 STORY 5

Improving Patient Value by Promoting Workforce Diversity

60 Approach to Improving Healthcare Access and Related Initiatives

62 Policy and Progress in Material Issues

66 Message from the CFO

1. Message from the Chairman
2. Message from
   the Chairman of the Appointment Committee
3. Message from
   the Chairman of the Compensation Committee
4. Directors / Audit & Supervisory Board Members

1. Corporate Governance

1. Risk Management

1. Performance Data
2. Relationships of Indicators

90 Financial and Pre-Financial Highlights (IFRS)

1. Review by Product

1. Development Pipeline

98 Consolidated Financial Indicators

100 Management's Discussion and Analysis

106 Consolidated Financial Statements

1. Dialogue with Stakeholders
2. Editorial Policy
3. Shareholder Information
4. Corporate Profile

Forward-Looking Statements

This report may include forward-looking statements pertaining to the business and prospects of Chugai Pharmaceutical Co., Ltd. (the "Company"). These statements reflect the Company's current analysis of existing information and trends. Actual results may differ from expectations based on risks and uncertainties that may affect the Company's businesses.

Disclaimer

In this report, information on pharmaceutical products or drug candidates under development may be included, but such information is not intended for promotional or advertising purposes, or as medical advice, etc. The trademarks appearing in the report are protected by trademark rights, copyright, and other intellectual property (IP) rights.

About the Cover

Chugai's brand character ChuLabo observes people around the world as they engage in the ordinary routines of everyday life. The cover expresses Chugai's commitment to protecting that everyday life by working day by day to generate innovation through its R&D activities.

Annual Report 2021

Annual Report 2021 3