Security Code:4584

Financial Results for 2Q FY 2023
(Fiscal Year Ending March 31, 2024)
Nov. 8, 2023

Biotech Striving for Value Creation－For a Comprehensive Healthcare System for Children,
Families, and Society －Kidswell Bio Corporation

Agenda◆ Financial Highlights in the 2Q FY2023◆ Business Highlights
Biosimilar Business
Cell Therapy Business (Regenerative Medicine)◆ Growth Strategies
IR Seminars

Copyright © 2023 Kidswell Bio Corporation All Rights Reserved.

2

Financial Highlights in 2Q FY2023

3

Financial Results in 2Q FY 2023 (PL): Income Statement
Unit：thousands yen

FY2023 ending March 31, 2024
Subject

Results for 2Q FY2022

Results for 2Q

Year-onyear ratio

Gross sales

1,116,111

581,870

52%

Cost of goods sold420,954351,901

84%

Gross profit

695,156

229,968

33%

Selling, general and administrative expenses

684,018

949,627

139%

R&D expenses

251,787546,693

217%

Other expenses

432,230

402,933

93%

Operating loss

11,137-719,658

Net loss-42,082

Net loss for the quarter-42,687

Forecast

Progressrate

3,500,000

17%

1,600,000

34%---1,500,000---744,646---1,550,000---780,251---1,550,000--• Progressing as planned for the forecast of FY2023.
• Contributions to sales from BS products, including the strong sales of GBS-007, are expected after the second half of the year.
• Gross profit declined in this quarter due to the depreciation of the yen and overseas inflation, in addition to the elimination of the
impact on sales of temporary income from the completion of master cell bank (MCB), which was recorded in the same quarter of theprevious year.
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Financial Results in 2Q FY 2023: Balance Sheet
Unit：thousands yen

Subject

4Q FY2022

2Q FY2023

Current assets

3,697,155

3,031,859（Cash and cash equivalents）

1,067,162

622,231（Trade receivables）

1,088,766

578,193（Products）

213,007258,596（(In-process inventory）

422,308

671,905（Advance payments）

821,536

816,463（Other current assets）

84,37384,468Non-current assets

197,609

161,978

Total assets

3,894,765

3,193,837

Current liabilities

1,055,839

731,434

Non-current liabilities

1,605,420

1,387,290

Total liabilities

2,661,259

2,118,724

Total shareholders’ equity

1,233,505

1,075,113

Total liabilities and shareholders’ equity

3,894,765

3,193,837• With the funds acquired through equity financing, (1) manufacturing in the biosimilar business proceeded as planned, and (2) cash
and deposit balances and stock capital improved.
• The company expects to improve capital efficiency by shortening the recovery period for manufacturing costs through thecooperation and support of partner companies.
Copyright © 2023 Kidswell Bio Corporation All Rights Reserved.

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Business Highlights

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Business Topics①【Biosimilar Business】
・Received Manufacturing and Sales Approval for GBS-010（Pegfilgrastim biosimilar）②【Cell Therapy Business (Regenerative Medicine)】
・Enrolled the first case of clinical research for children with cerebral palsy
under the initiative of Nagoya Univ.
・Completed a part of PMDA consultation for entry into a corporate clinical trial forchildren with cerebral palsy.

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Biosimilar Business
Received Manufacturing and Sales Approval for GBS-010（Pegfilgrastim biosimilar）

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Received Manufacturing and Sales Approval for GBS-010（Pegfilgrastim biosimilar）• Received manufacturing and sales approval for GBS-010 in Sept. 2023
• Launched the fourth BS productPegfilgrastim market (including originators and biosimilars) is
expected to continue to expand on a volume basis.

Outline of GBS-010

100 million yen

400

Development
PartnerMochida Pharmaceutical Co., Ltd.

Generic namePegfilgrastim biosimilar

Indication

Suppression of the onset of febrileneutropenia*1 by cancer chemotherapy

250

•

150

Competitors

350•

Biosimilar of sustained G-CSF preparation
pegfilgrastim

300

200

100

Approved as the first biosimilar for its
originator, G-Lasta (Pegfilgrastim)(Sales starting by the end of 2023)

50
0Results in 2020

*1:Febrile neutropenia is a condition with fever in which neutrophils, which are responsible for
eliminating pathogens that cause infection, decrease due to side effects of drugs for cancer.
*2Created by KWB based on Kyowa Kirin’s financial results materials

Results in 2021

Results in 2022

Results in 2023
(Forecast)＜Sales trend in G-Lasta (Pegfilgrastim) *2＞
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Core business for stable revenue• While many domestic pharmaceutical companies are promoting small molecule drug business, KWB
has been accumulating experience, know-how, and human resource development inbiopharmaceuticals, on which global pharmaceutical companies focus.
• Four biosimilars clinically developed with partner companies have been launched.

GBS-001

GBS-011

GBS-007

GBS-010Filgrastim BS（Approved in Nov. 2012）

Darbepoetin alfa BS（Approved in Sept. 2019）Ranibizumab BS（Approved in Sept. 2021)

Pegfilgrastim BS（Approved in Sept. 2023）

Fuji Pharma Co., Ltd.

Sanwa Kagaku Kenkysho Co., Ltd.

Senju Pharmaceutical Co., Ltd.

Mochida Pharmaceutical Co., Ltd.

• Biosimilar of G-CSF preparation
filgrastim for neutropenia, etc. Alfa
Biosimilar• Biosimilar of continuous Erythropoiesis
Stimulating Factor Preparation
Darbepoetin alfa

• Biosimilar of anti-VEGF antibody drug
ranibizumab• Strong sales and more orders than
expected• Received an approval of partial
modification of pharmaceuticalmanufacturing approval for macularedema associated with retinal vein
occlusion as additional indication ofRanibizumab BS in Sept. 2023

• Biosimilar of sustained G-CSF
preparation pegfilgrastim• No biosimilars have been approvedby competitors as of Sept. 2023.

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10Market Environment for Launched Biosimilars• Eighteen biosimilars approved in Japan• Replacement rate (BS share) of GBS-001 and GBS-011 developed by KWB is more than 80% on a
volume basis. (BS share includes other companies’ biosimilars)• GBS-007 and GBS-010 have not been approved as competitors at this time, and their market share is
expected to increase.

Nocompetitors

1

Ustekinumab BS

Stelara Subcutaneous Injection

Sept. 2023

2

Pegfilgrastim BS（GBS-010）

G-LASTA Subcutaneous Injection

Sept. 2023

3

Ranibizumab BS（GBS-007）

LUCENTIS kit for intravitreal injection

Sept. 2021

…

…

…

7

Teriparatide BS

Forteo Subcutaneous injection

Sept. 20198

Darbepoetin alfa BS（GBS-011）

NESP INJECTION PLASTIC SYRINGE

Sept. 2019

…

…

…

Over 80% of
BS shareApproval…

Over 80% of
BS shareOriginators…

No
competitors

Biosimilars（BS）

15

Infliximab BS

REMICADE for I.V.Infusion

July 201416

Filgrastim BS（GBS-001）

GRAN INJECTION

Nov. 201217

Epoetin Alfa BS

ESPO INJECTION

Jan. 201018

Somatropin BS

Genotropin

Jun. 2009

Source: Created by KWB based on Answers News

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Revenue outlook from biosimilars business• Launch of GBS-010 and approval of additional indications for GBS-007 are expected to lead to steadyearnings growth in the biosimilars business.
• Based on medium-term demand forecasts from partner companies, KWB plans to manufacture anddeliver BS products for stable supply.
• Drug substance and others, which are scheduled to be recorded in sales for the current fiscal year,
may berecorded in the next fiscal year due to adjusting the timing of manufacturing and delivery.
45
100 million yen

40
40
35
35
30
25
20
15
10
5

0
FY2019FY2020

FY2021

FY2022＜Sales trend in KWB’s BS business＞

FY2023（Forecast）

FY2024(Forecast)

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Profitability of the biosimilars business with change of the environment
Recognize the risk of a decline in profitability in the biosimilar business due to the external environment changes

Promote to expand profitability by reducing cost and other measures

Decline in profitability due to drug pricing system
Drug price revisions are implemented annually from FY2021

Since biosimilar's drug substances are manufactured by overseas CMOs, they
are affected by rising prices overseas and the depreciation of the yen.

Drug pricereduction

Initialsales
estimation

Countermeasures for risks of decline in profitability due toexternal factors

Initialestimated
manufacturing
cost

Expect to improve profitability within a few years due to measuresfor cost-reducing

Sales
estimation
Inflation
Measures toreducemanufacturing
costs

Yen’s
depreciation

Estimatedgross profit

Estimated
gross
profitCopyright © 2023 Kidswell Bio Corporation All Rights Reserved.

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Maximizing profits in the biosimilars business to fund growth investments
Maximize profits from biosimilars business and secure funds of growth investments by maximizing salesof BS launched, implementing measures to improve profitability, and launching new BS pipeline.

Sales
ProfitImprovement of sales
volumeFifth Product, etc.
（Under development study）

Maximizing the profitability of
the BS business

GBS-010（Pegfilgrastim BS）
GBS-007(Ranibizumab BS)

GBS-011(Darbepoetin Alfa BS)
GBS-001(Filgrastim BS)*BS：Biosimilar

Manufacturingcost

Reducing manufacturing
costs
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Cell Therapy Business（Regenerative Medicine）• Enrolled the first case of clinical research for children with cerebral palsy under the
initiative of Nagoya Univ.
• Completed a part of PMDA consultation for entry into a corporate clinical trial forchildren with cerebral palsy.

Copyright © 2023 Kidswell Bio Corporation All Rights Reserved.

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Progress in SHED Clinical Development
Started enrolling the first case of clinical research under the initiative of Nagoya Univ.
Proceed preparation for corporate clinical trials under the initiative of KWB

Autologous cells
Clinical research under the initiative of Nagoya Univ.

• Mainly confirm safety using
the patient’s SHED

Establishment of
manufacturing• Can be administered to thepatient self

Enrolled the first case

Allogenic cells

Company-led
clinical trials• Confirm the effectiveness andsafety using SHED
(allogeneic SHED) fromhealthy donors• Can be administrated to many
patients

LaunchCompleted a part of PMDA consultation

First stage••

Secondstage

Third stage

Fourthstage

Completion of establishment of S-Quatre Complete examination of Development of
GMP manufacturing
manufacturing methods GMP manufacturing
Completion of MCB manufacturingof clinical trial materials methods

FY2023 (Present)
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Positive negotiation of alliances and out-licensing with development partners

With the progress of the clinical development of SHED, active discussions with development partners for
conducting agreements has been started.
Expect to secure revenue from the cell therapy business following the conclusion of the agreements.

ROI＜ Expected revenue model from collaboration and out-licensing with development partners ＞

Revenue from royalty
and milestone for thesale

Upfront
Revenue from development milestone

Prior investment

Basic
Research

Preclinical

Clinicalresearch

Clinical trials（Phase１/２a）

Clinical research for children with cerebral
palsy under the initiative of Nagoya Univ.

Prior investment

Clinical trials（Phase２b/３）

Approval

Launch（Start of sales）* General dug development flow

Development partners (Pharmaceutical companies)
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Growth Strategies

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KWB2.0 Roadmap
To increase shareholders’ value, KWB will strengthen “visualize the improvement of business value".
・The goal of establishing a revenue base from the biosimilar business is in sight.
・KWB will implement clinical development of SHED and proceed partnering activities according to SHED pipeline progress.
Corporate ValueKIDS WELL, ALL WELL

Maximizing the value of cell therapy products

Accelerating cell therapy products development✓

Completing manufacturing SHED master cellbank (MCB)

Establishment of revenue base•

Proceeding clinical developments andaccelerating partnering activities✓ Establishing and maintaining astable supply system of the four BS
products•

Creating new SHED drug discovery seeds
and innovative technologies.

•

Launching cellular medicine/ cell therapy
products of SHED•

Continuous growth through development
candidate creation and partneringte creation
andpartnering•

Discontinuous growth through overseas
expansion and business acquisition
Cell therapy Bio Venture from Japan to theworld

Cell therapy business= Growth business
Biosimilar Business ＝ Revenue base of KWB（Profitability and growth investment in cell therapy business）
FY2023（Present）

Profitability
FY2025（3 billion yen of sales and 1 billion yen of operating profit ）FY2030 onward

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IR Strategies

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IR seminars
Basic IR Policy：Increase opportunities for dialogue with the stock market and investors＜Annual IR Schedule＞

Jul.

Financial
Results

IR
Seminars

Aug.

Sep.

Oct.

Nov.

Dec.

Announcement of
Financial Result for 2Q
FY 2023

Announcement of
Financial Result for
1Q FY 2023

IR Seminar for
Individual
shareholders inTokyo and Osaka(Hybrid)

IR seminar for analysts
and institutional investors(Hybrid)Videostreaming

1Q FY2024

4Q FY2023

3Q FY2023

2Q FY2023

Jan.
2024

Feb.

Mar.

Apr.

Financial result
meeting
Video streaming

Jun.

ShareAnnouncement of
Financial Result for holders’Meeting
4Q FY 2023

Announcement of
R＆D
Financial Result for
Meeting
3Q FY 2023

IR Seminar forindividual shareholders(To be confirmed)

May

IR seminar for analysts
and institutional investors(Hybrid)Videostreaming

Actively join IR events for company briefing
Continuing timely video distribution at the time of financial results and press releases
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KIDS WELL, ALL WELL
All for Kids, Kids for All

Cautionary Statement

This information material is provided for understanding Kidswell Bio Corporation (“KWB”),
not for soliciting investment in KWB shares.

Information provided in this material may contain so-called “forward-looking statements.”
These statements are based on current expectations, forecasts, and assumptions that are
subject to risks and uncertainties, which could cause actual outcomes and results to differ
materially from these statements. Risks and uncertainties include success rate of R&D
projects, new regulations and rules, relations with partners in the future, etc.

This material includes information on pharmaceutical products and regenerative medicine (orrelated products), etc., which is being developed or launched. However, this is not intended
to promote our products or provide medical advice.

Copyright © 2023 Kidswell Bio Corporation All Rights Reserved.

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Appendix

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Our vision

All for Kids, Kids for All

KIDS WELL, ALL WELL
Focus areas

Business
Direction​

Pediatric diseases including
juvenile diseases,
intractable & rare disease

Targeting diseases which hasless accessibility for sufficient
medical treatment​

Families

Educational
Institutions

KIDS WELL

MedicalInstitutions

Society

All for Kids, Kids for All

Friends

Government

For Children•Under the declining birthrate and aging population, reducing the burden on children
is a major social issue.
•Provide new pharmaceuticals and therapeutics to patients suffering from diseases
and contribute to the realization of a society where children and adults who support
children live happily and brightly.
Copyright © 2023 Kidswell Bio Corporation All Rights Reserved.

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Management Member（From June 29, 2023）

Directors

Shinya Kurebayashi
President & CEO

Jun. 2004

Massachusetts Institute of Technology, MSc, Physics

Apr.2004

Joined Goldman Sachs Japan. Worked in Investment
Banking Div. at Goldman Sachs Japan and involved in
M&A, IPOs.

Aug. 2009

Joined Morgan Stanley (Mitsubishi UFJ Morgan Stanley
Securities) and involved in investing banking

Oct. 2014

Jointed ImPACT of Cabinet Office

Sept. 2015

Joined Advanced Cell Technology and Engineering LTD(ACTE) as Business Administration Officer

Mar. 2019

Joined Kidswell Bio Corporation (f/k/a Gene Techno
Science Co., Ltd.) as Corporate Officer, Chief Business
OfficerJun. 2023

Corporate
Officers

President & CEO

ShinyaKurebayashi

Formerly worked at Goldman
Sachs Japan, Morgan Stanley
and Advanced Cell Technology
and Engineering Ltd.

Board Director

Masayuki
Kawakami

Formerly worked at FUJIFILM
Corp. and FUJIFILM
Pharmaceuticals USA

Outside Director

Norikazu
Eiki

Former Chairman of Bayer Japan

Chief Communication
Officer (CCO)​

ShinyaKurebayashi

Chief Operating
Officer (COO)
Chief Development
Officer (CDO)

Masayuki
Kawakami

Chief Scientific Officer（CSO）

Yasuyuki
Mitani

Formerly worked at Astellas
Pharma Inc.

Chief Manufacturing
Officer（CMfO）

Munechika
SakabeFormerly worked at FUJIFILM
Corp.

Chief Administration
Officer (CAO)​

Yasuo
Sakae

Formerly worked at Astellas
Pharma Inc.

Appointed as President & CEO
Copyright © 2023 Kidswell Bio Corporation All Rights Reserved.

26

Business Structure: Growth Potential & Stability

KWB is a unique bio-venture that established stable business foundation by biosimilarbusiness and promote investment in R&D activities for further growth

Stability

Growth Potential

Biosimilar Business

Cell Therapy Business(Regenerative Medicine)​

Stable Business Foundation

Remarkable Growth Foundation

Income from launched four BS products（Received Manufacturing and Sales
Approval for GBS-010）

Accelerating development of cell therapy
products with SHED(Start clinical research for cerebral palsy)

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27

Revenue model depending on development progress (1)Aiming for collaboration with development partners (pharmaceutical companies, etc.),from efficient development investment to revenue
Basic Research
Research Target

Development & ResearchPreclinicalApproval

Clinical Trial

Launch（Start of sales）* General dug development flow

Out-licensing

Biosimilar
Business

Establishment of drug substancemanufacturing methods

Collaborative research with development partners

Upfront

Revenue from development milestone

Collaborative Research Agreement, etc.

Cell
TherapyBusiness

Out-licensing
Collaborative research with academia andresearch institutes
Upfront

Revenue fromroyalties for sale ofdrug substance

Development by development partners
Revenue from development milestone

Collaborative development andOut-licensing agreement, etc.

Note) The above figure is an image of revenue model. KWB will proceed an appropriate development structure according to development pipeline.

Revenue from royalty andmilestone for the sale

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28

Revenue model depending on development progress (2)Cell Therapy Business: High-risk high return revenue model
Biosimilar Business: Low-risk middle return revenue model
Basic
Research

Development &Research

In-house R&D period

Clinical Trials

Approval

Launch（Start of sales）

Outlicensing Period for receiving milestone and royalty income from development partners

Revenue

Cell Therapy
Business
Biosimilar
Business

PeriodCopyright © 2023 Kidswell Bio Corporation All Rights Reserved.

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