証券ｺｰﾄﾞ:4584

Financial Results for 1Q/FY2021(Fiscal Year Ending March 31, 2022)
August 12, 2021

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 include
success 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Change of Company Name

Kidswell Bio Corporation
Kids＋wellness
All for KIDS, KIDS for All
Biotech Engineering Company,
Striving for Value Creation
For a comprehensive healthcare systemfor children as well as families and society

Made a new start as Kidswell Bio Corporation, or KWB, from July 1, 2021.
Under “Kids Well, All Well”, we will make our goal come true.

3

Business and FinancialHighlights in 1Q/FY2021

4

Overview of Financial and Business Highlights
Financial Highlights◆Financial Highlights in 1Q/FY2021





Financial results were in line with the forecast.
Included 96 million yen for MCB completion in cost of sales as budgeted(It is a reserve for loss on orders according to the accounting method.）R&D activities are proceeding as scheduled.
GBS-007 is in the final preparation for commercial manufacturing towardmanufacturing and marketing approval.
No impact on business performance due to the COVID-19 pandemic

Business Highlights

New Biotech（Regenerativemedicine/ CellTherapy）

Others• JRM-001 was designated as the Orphan Drug/Medical Device by Ministry ofHealth, Labour and Welfare.
• Academic advisor was appointed specializing in research on the practicalapplication of regenerative medicine development.
• For collecting deciduous teeth to build Regenerative Medicine Business
Model utilizing SHED, Chivo Net, Children Volunteer Network for Future
Medical launched and collaboration with Showa University Dental Hospital
started.

5Consolidated Financial Results in 1Q/FY2021
Unit:thousands yen

SubjectResults for
1Q/FY2020

Gross sales

121,294

Forecasts for FY2021
Forecasts

303,367

1,900,000

 Included milestones and other profits in the 1Q ofFY2020
 Included profits from GBS-001 and GBS-011.
 Included 96 million yen for MCB completion in cost ofsales as budgeted (It is a reserve for loss on orders
according to the accounting method.）

Cost of goods
sold

4,971

121,792

1,020,000

Gross profit

116,322

181,574

880,000

Selling,
general andadministrative
expenses

354,080

490,8022,600,000

R&D expense

Highlights

Results for
1Q/FY2021

138,411296,718

1,800,000

Otherexpenses

215,668

194,083

800,000

Operatingprofit△237,757△309,227△1,720,000

 Although R&D expense increased from the previousterm, it was due to carrying over of R&D expenses
into FY2021. The final stage of commercial
manufacturing of GBS-007 is smoothly proceeding.
 Continuously streamlining Selling, General and
Administrative expenses

6

Highlights of Mid-Term
Strategic Plan
From FY2021 to FY2025

7

RoadmapThe key to further growth isto expand partnering for regenerative medicine and new biologics pipelineA) Turning profitable in FY2022
B) 3 billion yen of sales and 1 billion yen of operating profit in FY2025 and huge profit expansion after 2025
C) Sufficient R&D investment for future business growth

B Profit Expansion

3 billion yen of sales
1 billion yen of operating profit
OperatingProfit

High Return

Further expansion of profits bylicensing out new regenerative &new biologics medicines

Unit:million

A Turning profitable

More stable profitability by reducing
manufacturing costs of existingbiosimilars and launching newbiosimilars
Stable Profit

0C Sufficient R&D investment for futurebusiness growth-1,000Initially
expectedbreak-evenpoint-2,000
FY2020

FY2022

FY202588

Progress
Highlights in 1Q/FY2021
Licensingout

SHED
Collaborative
ResearchCSC
JRM-001

R&D

New Biotech
SHED & CSC

New Biologics

Biosimilars
Fourth Product

Technology

Supply System ofSHED
Establishment of MCB

Designer Cell

High-Yield Protein
Producing Cell Lines

ProfitExpansion

StableProfit

GBS-007
Cost Reduction

GBS-001
Cost Reduction

GBS-001
Sales

GBS-011
Loyalties

GBS-007
To be approved
shortly99SHED: Boosting licensing-out activities
UPDATE

Showed positive effectiveness of non-clinical studies (animal studies) in SHED pipelines
Accelerating licensing-out activities to pharmaceutical companies
Partners

Number ofpatients(Domestic)

ORTHOREBIRTH

2,000 patients
per year

15 out of 10,000
newborns

Ganglion
regeneration

Mochida Pharmaceutical

100 patients

ー

None

Nerve protection,activation andregeneration

Tokyo Metropolitan
Institute of Medical
Science, Nagoya
University, Tokyo
Medical and Dental
University

2,000 patients
per year,
30,000 patientsin total

100,000 patients
per year, 1.7
millions patientsin totalNagoya University

5,000 patients
per year,100,000 patientsin total

25,000 patients
per year,
500,000 patientsin total (US, EUand Japan)

Target disease

symptom

Existing
Treatment

TherapeutictargetPediatric
diseaseCleft lip and palate

Eating andspeechdisorderLip arthroplasty+ iliac bonegraft

Maxilla boneregeneration

Pediatric
diseaseCongenital Isolated
Hypoganglionosis

Intestinal
obstruction

Enterectomy,
colostomy

Pediatric
diseaseIncluding
Pediatric
disease※Non-disclosureof details

Number ofpatients (Global)

Cerebral palsy

Quadriplegiaand PosturedisorderSpinal cord injury

Loss of motor
function andsensation

None

Nerve protection,
activation andregeneration

Non-union fractures

Chronic pain,
gait
disturbance

Surgery

Boneregeneration

Hokkaido University andSpinal Injuries Center

100,000 patients
per yearー

Peripheral nerve
palsyMotor function
and sensation
disorderNerve
reconstruction(Autologousnervetransplantation)

Peripheral nerve
regeneration

Oita University

8,000 surgeries
per yearー

Bone-relateddiseases※※※

Showa University Schoolof Medicine※※

Ophthalmologic
disease※※※

Gifu PharmaceuticalUniversity※※

10Designer Cell, Next Generation Cell TherapyAiming at Global Expansion
Designer Cell can Change Patients’ Future : 2nd Generation Cell Therapy

ｘCell Therapy

Enhanced therapeutic efficacy
and cell directionality fordisease sites＝Designer Cell

1st generation
2nd generation Cell Therapy R&D
FY2021

Clinical Trial

FY2025

FY2030
2nd Generation “Designer Cell”

PermanentCure
Treatment

Symptomatic
Treatment

Vaccine（Prevention・Treatment）

DTx

1st Generation
Cell Therapy
Non-Recombinant
Type of Stem Cell etc

Small, Mid
Molecule Drug

Recombinant Cell Therapy (StemCell-Based)
Add/Enhance Functions
by Genetic Engineering

NucleicAcidMedicine

Antibody Drug

Pediatric diseases
Infection

Life style
relatedDegenerative（Nerve, Organ）

Autoimmunity* Created by Kidswell Bio Corporation referring from Strategic Proposal of Designer Cell by Japan Science and Technology Agency.

CancerGene11

MCB and Stable Supply SystemHighlights① Infrastructure② Japan's firstsupply system③ Stable supply④ Licensing-out

・Steady progress of Master Cell Bank (MCB), which is a raw material forvarious regenerative medicine
・Establishment of Japan‘s first supply system under the guidance*issued
by the Ministry of Economy, Trade and Industry
・Stable supply of deciduous teeth by registered donors (ChiVo Net)・Accelerating licensing-out activities with establishment of MCB and stablesupply system*Guidance on the supply of human cells,
which are the raw materials regenerativemedicine

New Treatment Method for Patient(Spinal Cord Injury, Non-Union Fractures, Cerebral Palsy）

New medication and regenerative medicine
SHED supply system for final product manufacturing
Expanding Donors

Creation of new treatment
method with SHED

Partners (Pharmaceutical Companies)
Final Product
Manufacturing & Marketing Approval
Licensing-out

Deciduous teeth donation
Medical Institutions

Raw material collection andmanagement system basedon the law
University of Tokyo
Hospital, Showa University
Dental Hospital

Underdevelopment

MCB（SHED manufacture which is a raw
material for various regenerativemedicine ）Nikon CeLL Innovation Co., Ltd.

Early
Licensing-out

Collaborative
Research（Universities andInstitutions）

KWB

Pipelines
1212

Strengthening IR activities

IR activities

R＆D
Meeting to beheld in Autumn

Online Meetingwith Private
Investors(Coming soon)

One-on-One
Meeting with
Institutional
Investors

Issuance ofCompany Report13
13

Pipelines

14

Biosimilars

15New Biologics

16

New Biotech（Regenerative medicine/ Cell Therapy）

17

KIDS WELL, ALL WELL