Security Code:4584

Financial Results for 1Q FY 2023
(Fiscal Year Ending March 31, 2024)

Aug 07, 2023

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

Agenda Financial Highlights in the 1Q FY2023
 Business Highlights
 IR Strategies

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Financial Highlights in 1Q FY2023

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Financial Results in 1Q FY 2023 (PL): Income Statement
Unit：thousands yen

Subject

FY2023 ending March 31, 2024Results for 1Q FY2022

Year-onyear ratio

Results for 1Q

Progressrate

Forecast

Gross sales

610,878

45,979

8%

Cost of goods sold292,703

853

0%

--

--

Gross profit

318,175

45,126

14%

Selling, general and administrative expenses

356,167

500,175

140%

--

--

105,490

312,535----

250,676

187,640

Operating loss

-37,991-455,049---1,500,000--

Net loss-80,652-470,326---1,550,000--

Net loss for the quarter-80,954-470,629---1,550,000--(Cost of sales ratio)(Cost of sales ratio)
R&D expenses(Cost of sales ratio)

Other expenses

296%

3,500,000

1%1,600,000

20%

-75%

• Progressing as planned for the forecast of FY2023.
• Contributions to sales from BS products, including the strong sales of GBS-007, are expected in the second half of the year.
• R&D activities in the cell therapy business including SHED goes well.
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Financial Results in 1Q FY 2023: Balance Sheet
Unit：thousands yen

Subject

1Q FY2023

4Q FY2022

Current assets

3,697,155

2,846,479(Cash and cash equivalents）

1,067,162

623,787（Trade receivables）

1,088,766

170,945(Products)

213,007258,596(In-process inventory)

422,308

868,494(Advance payments)

821,536

821,533----

84,373103,122----

197,609

197,303

Total assets

3,894,765

3,043,782

Current liabilities

1,055,839

767,221

Non-current liabilities

1,605,420

1,508,375

Total liabilities

2,661,259

2,275,596

Total shareholders’ equity

1,233,505

768,186

Total liabilities and shareholders’ equity

3,894,765

3,043,782(Long-term debts to be repaid within one year from a subsidiary）(Other current assets)(Allowance for doubtful accounts)
Non-current assets• Started equity financing in July 2023 ⇒ Expected to improve cash balance and total shareholders’ equity after 2Q FY2023.
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Business Highlights

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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 Value

Maximizing the value of cell therapy
products

Accelerating cell therapy products
development
Completing manufacturing SHED master
cell bank (MCB)

Establishment of revenue base•

Proceeding clinical developments andaccelerating partnering activities

Establishing and maintaining a stablesupply system of the first, second andthird BS products•

Creating new SHED drug discovery seeds
and innovative technologies.

•Establishing a stable supply system forthe launch of the fourth BS product•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 fromJapan to the world

Cell therapy business= Growth business

Biosimilar Business ＝ Revenue base of KWB（Profitability and growth investment in cell therapy business）
FY2022（Present）

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

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7Business Topics① 【Biosimilar Business】
Progress of the development of the fourth BS product② 【Cell Therapy Business】
Progress of preparation for the clinical research led byNagoya Univ. and expecting to be administrated topatients by the end of the calendar year of 2023

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① Development Progress of the Fourth BS

Increasing the sales due to positive demand for GBS-007 and the launch ofthe fourth BS by the end of this year
(100 million yen)40

Approval
PeriodPartners

GBS-001(Filgrastim BS)

Nov. 2012

Fuji Pharma Co.,Ltd.

GBS-011(Darbepoetin Alfa BS)

Sept. 2019

Sanwa Kagaku
Kenkyusho Co., Ltd.

Sept. 2021

Senju
Pharmaceutical Co.,Ltd.

By the end ofthe calendar
year of 2023

Undisclosed

Name of BS Product

3530
25
20
15

GBS-007(Ranibizumab BS)

105

Fourth BS Product0
FY2019FY2020

FY2021

FY2022

FY2023（Forecast）＜Sales Trends of Biosimilar Business＞
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9Maximizing the profitability of the BS Business with Financing
Using working capital to increase manufacturing volume associated with the growth of the biosimilarbusiness and maximize future profit

ProfitMaximizing theprofitability of the BS
business

Fifth Product, etc.

（Under development study）

Fourth BS Product（Under development）

GBS-007(Ranibizumab BS)
GBS-011(Darbepoetin Alfa BS)
GBS-001(Filgrastim BS)

Financing
Working
capital formanufacturing

18th series of convertible bonds with
exercise price adjustment clause（Approximately 3 billion yen at thecurrent stock price）
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② For the launch of clinical development of SHED
Significant progress in SHED's basic research and the completion of Master Cell Bank (MCB).
"Clinical development" scheduled to start in 2023

The probability of concluding a contract with a potential development partners that has
been discussed has increased.
Basic Research to Clinical Development（MCB manufacturing continues thereafter.）Development Partners
Phase１
Basic ResearchPreclinicalClinicalResearch

Mainly Clinical Development onward
Phase２Clinical Trial（P1/2a）Phase３Clinical Trial (P2b/3)

Approval/ Launch【Highlights of 1Q FY2023】 Preparations for the launch of clinical research for participants with cerebral
palsy led by Nagoya University are progressing.
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Image of Growth Investment of SHED

Reshown

Focusing on SHED development and accelerating investment for increase in corporate value

The amount of KWB’s growth investment in SHED has
significantly changed.

Making investments for launching SHED regenerative medicine/ cell therapy products with equity financing
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Image of Growth Investment of SHED 【Updated version】
Due to the increasing probability of collaborating with development partners, the main scenario forcommercializing SHED has shifted to promote commercialization with development partners from KWB alone.

In addition to significantly reducing the KWB’s financial burden, the main sources of funding for growthinvestment in SHED are expected as follows.

①Revenue from Biosimilar Business②Lum-sum contract payments from development partners, development milestone income, etc.
3 to 5 billion yen（From basic research to early clinical development)

Development Partners Over 5 billion yen(Mainly Clinical Development onward)
Phase１
Basic ResearchPreclinicalClinicalResearchPhase３Phase２Clinical Trial（P1/2a）

Clinical Trial (P2b/3)

Approval/ Launch

Costs related to the commercialization of multiple SHED cell therapy (regenerative medicineproducts) in Japan and overseas, including the second generation: over10 billion yen
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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.

Aug.

Sep.

Oct.

Announcement ofFinancial Result for

1Q FY 2023

IR Seminar for Individualshareholders in Tokyo andOsaka (Hybrid)

Nov.

Announcement of

Financial Resultfor 2Q FY 2023

1Q FY2024

4Q FY2023

3Q FY2023

2Q FY2023

Dec.

Jan.
2024

Feb.

Announcement ofFinancial Result for

3Q FY 2023

Mar.

R＆D
Meeting

Apr.

May

Jun.

Announcement of

Share-

4Q FY 2023

Meeting

Financial Result for holders’（Hold quarterly IR seminar for individual investors from October 2023 onwards）

Continuing timely video distribution at the time of financial results and news announcements

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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.

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Appendix

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Pipeline Highlight of Cell Therapy (Regenerative Medicine)
Development ProductFirst
Generation
SHEDSecond
Generation
SHED

Target disease2

Development Stage*1
Research Target

Research

Preclinical

ClinicalNumber of Patients*

Partners

Domestic

Global

Cerebral palsy

Nagoya University, Tokyo
Medical and Dental
University2,000 patients per
year, (30,000patients in total)

125,000 participants(under 10 years old)

Congenital Isolated
Hypoganglionosis

Mochida Pharmaceutical

100 participants―

Spinal cord injury

Nagoya University

5,000 patients per
year, (100,000patients in total)

13,000 cases per
year

Ophthalmologic
disease, etc.

Gifu Pharmaceutical
University*3*3

Non-union fractures

Hokkaido University

100,000 patients per
year―

Cleft lip and palate

ORTHOREBIRTH

2,000 patients per
year

15 out of 10,000
newborns

Brain cancer

Hamamatsu University
School of Medicine

20,000 patients peryear

27,000 parents peryear

Spinal cord injury

Nagoya University

5,000 patients peryear, (100,000patients in total)

13,000 cases peryear

Neurodegenerative
disease, etc.

OtherModalities

Autoallergic disease,etc.
Exosomes andmitochondria, etc.

*1【Our development stage definitions: Preclinical indicates pharmaceutical development and preliminary toxicity studies for clinical trials, Research indicates acquired animal POC, Research Target indicates before acquisition of animal POC, *2 Internal research based on
Global Data, Global Cancer Observatory, *3 Details not disclosed

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19Promote SHED R&D activities to improve business value
For launching the world’s first SHED cell & gene therapy

SHED Drug Discovery
platform

GMP-compliant SHED MCB

SHED: 1st generation

SHED: 2nd generation

Strive to establish SHED
business

Designer cells

Target diseases:
Diseases related to nervous, muscularand bone system
Market potential:
Expect to grow 700 to 800 billion
yen market size by 2040*1(Global)*1: KWB’s research

Target diseases:
Genetic disease, neurodegenerative
disease and cancer
Market potential:
Expect to grow over 1 trillion yen market
size by 2028*2(e.g. CAR-T cell therapy: over 13.5 billion
dollars in the world)*2 & 3: Estimated by KWB based on public information from various related institutions and organizations

Other modalities andsynergies
For other modalities• Products utilizing SHED-derived cellorgans and extracellular vesicles(exosome and mitochondria, etc.)• Drug Delivery System utilizing SHED
Market potential:
Expect hundreds of billions
yen market size*3
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Delivering SHED products (treatment methods) to patients
Delivering SHED regenerative medicine products for diseases for which
effective treatment methods have not yet been established
Congenital Isolated
Hypoganglionosis

Cerebral palsy(DOI:10.1302/0301-620X.85B2.14066)(DOI: 10.7759/cureus.33680)

Ophthalmologic disease(doi:10.1136/jmg.2007.054270)

Brain Cancer(FOUNDATION PARALYSIE CEREBRALE“White Paper on cerebral palsy”)(DOI: 10.3390/cancers11010111)

Spinal cord injury(DOI:https://doi.org/10.1016/S1474-4422(09)70162-0)

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