証券ｺｰﾄﾞ:4584

Financial Results for 3Q/FY2021(Fiscal Year Ending March 31, 2022)
February 4, 2022

Kidswell Bio Corporation

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 “forwardlooking statements.”
These statements are based on current
expectations, forecasts and assumptions that are subject to risks anduncertainties, which could cause actual outcomes and results to differ
materially from these statements. Risks and uncertainties includesuccess rate of R&D projects, new regulations and rules, relations withpartners in the future, etc.
This material includes information on pharmaceutical products andregenerative medicine (or related products), etc., which is being
developed or launched. However, this is not intended to promote ourproducts or provide medical advices.

2

Business andFinancial Highlights in3Q/FY2021

3

Overview of Financial and Business Highlights
Financial Highlights◆ Financial Highlights in 3Q/FY2021
Sales results were in line with the forecast.（started launching
Ranibizumab biosimilar）



R&D is steadily proceeding by realized business alliances
Strengthened financial stability by the proceeds from investment
securities sales.

No impact on business performance due to the COVID-19 pandemic.

Business Highlights

Biosimilar• GBS-007: Received Approval Manufacturing and Sales in Japan andlaunched in Dec. 2021.

New Biotech（Regenerativemedicine/ CellTherapy ）• Executed a business alliance agreement with Metcela Inc.in theregenerative medicine field• Executed a development agreement on “designer cell”, the 2nd generation
cell therapy, with BioMimetics Sympathies Inc.(BMS)• Executed a collaborative research agreement with NanoCarrier Co., Ltd.
• Started manufacturing master cell bank (MCB) in compliance with GMPOthers• Recorded extraordinary income (sales profit of investment securities) inaccordance with about 500 million yen cash proceed.
4Consolidated Financial Results in 3Q/FY2021
Consolidated income statement
Subject

Gross sales

Results for
3Q/FY2020

720,859

Unit:thousands yen

Forecasts for FY2021
Results for
3Q/FY2021

1,383,239

Forecasts

1,900,000

 Profits from GBS-001 and GBS-011GBS-001、011 exceeded the plan Recorded drug substance sales related to the manufacturing process
for the 4th biosimilar product Included sales of GBS-007
 Included 96 million yen for MCB completion in cost of sales asbudgeted (It is a reserve for loss on orders according to theaccounting method.） Full-year forecasts include the temporary cost of approximately 650
million yen of the cost of the manufacturing process establishment for
the 4th biosimilar product and related to the completion of the MCB.

Cost ofgoods sold86,186

458,501

1,020,000

Gross profit

634,673924,737

880,000

Selling,
general andadministrative
expenses

1,282,078

1,357,696

2,600,000

R&D
expenseHighlights

600,660

770,4211,800,000

Other
expenses

681,417587,275

800,000

Operatingprofit-647,405-432,958-1,720,000

 Most of R&D expense is allocated to 4Q.
 A part of R&D expense up to the 3Q will be shifted to the 4Q.
 Reduced development costs through continuous and review ofdevelopment plans.
 Full-year results are expected to be lower than expected due to theabove.
 Continuously streamlining selling, general and administrative
expensesNote: Net loss attributable to owners of parent was -94,000 yen (full-year forecast : 1,323 thousand yen) due to extraordinary income(gain on sale of investment securities)5Consolidated Financial Results for 3Q/FY2021
Consolidated balance sheet

Recorded cash proceeds of 500 million yen from investment securities sales
Driving KWB’s mid-term business strategy with increasing sales revenue of GBS-007 and execution of outstanding warrants

AssetsCurrent
assetsNoncurrent
assetsCash and cash equivalents

Liabilities(in thousand yen)

1,253,307

Currentliabilities

Trade payables

32,008Trade receivables

909,765

Income taxes payable

78,034

Products

119,056

Reserve for loss on orders

475,243

In-process inventory

693,857

Other current liabilities

459,292

Advance payments

545,749

Convertible bonds

100,000

Other current assets

200,743

Long-term debts

600,000

Tangible fixed assets

2,025

Allowance for retirement benefits

18,105Intangible fixed assets

3,255

Other non-current liabilities－Non-current
liabilities

Total liabilities
Investments and other assets

Common stock

1,420,030

Capital surplus

10,725,630Retained earnings△10,173,107

Treasury stock
Accumulated other comprehensive income

Equity warrants
Total assets

3,900,557
3,900,557

1,762,684

Shareholders’ equity

172,795

Shareholders'capital

Grand Total(in thousandyen)

Total shareholders’ equity
Grand total△73－
165,393
2,137,872
3,900,557

6

Updates of Mid-Term
Strategic Plan
From FY2021 toFY2025

7

Key Updates in Mid-Term Strategic Plan
Key updates in 3Q/FY2021

UPDATE!

Business AllianceAgreement with Metcela
Expansion and further
development in regenerative
medicine field of KWB andMetcela

Licensing-out

SHED

R&D

RegenerativeMedicine
SHED & CSC

New Biologics

Biosimilars
Fourth Product

Technology
Development

Supply Systemof SHED
Establishment ofMCB

Designer Cell

High-Yield
Protein Producing
Cell Lines

CSC
JRM-001

UPDATE!

Development Agreementwith BioMimetics
Sympathies Inc.
Development technology
of culture medium ×SHED inaddition to NanoCarrier’s
micellar nanoparticle
technology×SHEDUPDATE!
ProfitExpansion

GBS-001
Cost Reduction

Manufacturing MCB incompliance with GMP
Steady progress for thecompletion of the MCB
in compliance with GMP

GBS-007
Cost Reduction

CompletedStable
Profit

GBS-001
Sales

GBS-011
Loyalties

GBS-007
Launched inthe market
UPDATE!

Progressing as scheduledHigh expectation in thefirst BS in ophthalmology
field
Contributing to thestable businessfoundation as a revenue
source8

GBS-007: Launched new BS as the first BS in theophthalmology fieldHighlights
 GBS-007 launched by Senju Pharmaceutical Co., Ltd. from Dec. 9, 2021. Included thesales in the 3Q
 Expecting acquiring market share in existing products market as the first BS in theophthalmology field.
 Adding indications and further expansion■Outline

Biosimilar of Anti-VEGF antibody drug Ranibizumab as a medicine forage-related macular degeneration■Target disease

A disease in which waste products accumulate in the macula, which
controls eyesight in the eyeball, or new blood vessels form in themacula with aging, making it difficult to see■Development Partner

One of the leading domestic companies in the field of ophthalmology,
which handles a wide range of medical drugs for ophthalmology andotolaryngology.

■Market of Anti-VEGF
antibody drug

Targeting the domestic market for existing treatments for age-related
macular degeneration
Lucentis
About 27 billion yen (Domestic, FY2020)
EyleaAbout 65 billion yen (Domestic, FY2020)■Outlook

Sales will start from this fiscal year with approval.
The indications for this drug are only a part of the preceding products.
Additional indications will be added accordingly.
Actively promoting not only domestic but also overseas expansion,
which has a larger market.

Age-related maculardegeneration
Senju PharmaceuticalCo., Ltd.

9Key of MCB in cell medicines■ SHED: Research & Development
Selected oftarget diseases

Basic researchNon-clinical study

Major target diseases
Spinal cord injury
Cerebral palsy
Non-Union FracturesEffectiveness in
multiple pipelines

Licensing-out
alliance

Clinicaltrial

Manufacturingand marketing
approval

Launchto themarket

Establishment of manufacturing processof SHED MCB as raw materials for
final product manufacturing↓■Production (Manufacturing system based on law ）Deciduous
teeth donation

Tooth
extraction

Cultivation（MCB）

Under
development
University of Tokyo
Hospital, Showa University Nikon CeLL
ChiVo Net
Dental Hospital
innovation

Alliances and licensing-out withpharmaceutical companies
Intermediate product from Japan withvarious applicability, including overseasmarket※ Providing not only as a cell
medicine but also as a raw materialfor manufacturing clinical exosomes
Establishment of MCB under is essential for
future development

UPDATE!
（SHED Source Supply Service）
Providing supply service of SHED intermediate
product

Started manufacturing MCB in compliance with
GMP in Oct. 2021
Steady progress for the completion of MCB
10

Designer cell development -New drug

discovery－

Shifting development trends in domestic & overseas:
designer cell for radical treatment
1900~2000

2000~2020

2020～

Small
molecule medicine

Antibody drugs

Next generation

Designer Cell

RegenerativeMedicine

Modality of Celltherapy

Nucleic acid medicine

Antibody drugs→

Antibody drugs

Protein/Peptide
pharmaceutical→Protein/Peptide
pharmaceutical→

Protein/Peptide
pharmaceutical

Small molecule medicine→

Small molecule medicine→

Small molecule medicine

Modality ofmolecule

Diversification of modalities (types of treatment methods) by increasing
the speed of technological innovation
Source: KWB from strategic proposal “Designer Cell” by Japan Science and Technology Agency

Collaborative development wit NanoCarrier and BMS
Sept. 2021
NanoCarrier
Collaborative Research Agreement

Dec. 2021
BioMimetics Sympathies Inc.
Development AgreementAiming for global expansion through development in line with global trends

11Business Alliance with Metcela
Highlight

Metcela has been developing regenerative medicine for chronic heart failure.

Combining management resources, knowledge and technologies and accelerating development in theregenerative medicine field of KWB and Metcela

Expecting new pipelines in regenerative medicine field

Integrating scattered technologies and know-how in Japanesebusiness development field and building up efficient R&D system
As-Is

Mechanism ofDrug Action

Competing for HR
Independentdevelopment
Scatteredtechnologies
and know-howCompany AManufacturing
technology forclinical trial
products

Company C

Inefficient development
Long development period

Stopdevelopment

To-Be

Drug
discovery

Company B

Clinicaldevelopment

Combining
individual
technologies andknow-how for building up
efficient development
systemMechanism ofDrug Action

Drugdiscovery

Manufacturing
technology forclinical trial
products

Clinicaldevelopment

Company D

Efficient development
Promoting newtechnologies
Higher success rate
Faster development

Realization ofdevelopment

Stopdevelopment

Realizationofdevelopment

12KIDS WELL, ALL WELL