Financial Results for theSecond Quarter of the Fiscal YearEnding January 31, 2022
September 16, 2021

SanBio Company Limited(TSE Mothers: 4592)

Table of Contents

1Financial Results

2SB623 Approval in Japan and SubsequentDevelopments

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Q&A©2021 SanBio Company Limited

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1. Financial Results©2021 SanBio Company Limited

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Consolidated Income Statement
R&D expenses increased due to higher manufacturing-related expenses in preparation for
approval filing of SB623 for chronic effects of traumatic brain injury (TBI program)
Q2 FY2021.1Results(A)

Q2 FY2022.1Results(B)

FY2022.1
Forecast(B)-(A)

Unit: Million yen

Revenue----R&D expenses

1,798

2,251+453

3,820

Operating expenses

2,570

3,052+482

5,786

Operating income-2,570-3,052-482-5,786

Net income-3,207-2,134+1,073-5,877

Yen/USD exchange
rate

108.45108.79-110.00©2021 SanBio Company Limited3

Consolidated Balance Sheet
Despite declines in cash & cash equivalents and in net assets,
SanBio maintained a stable financial position
As of January 31, 2021
(A)

As of July 31, 2021
(B)

(B)-(A)

Unit: Million yen

Cash & cash
equivalents

12,4808,794-3,686

444

453

+9

13,131

9,515-3,616211

193-18

Total assets

13,343

9,709-3,634Current liabilities

2,468

1,857-611

Non-current liabilities

2,525

2,300

-225

Total liabilities

4,993

4,157-836

Total net assets

8,349

5,552

-2,797

Total liabilities and net assets

13,343

9,709-3,634

Supplies
Current assets
Non-current assets©2021 SanBio Company Limited4

2. SB623 Approval in Japan and SubsequentDevelopments©2021 SanBio Company Limited

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Toward Filing for Japan Product Approval
Discussions are underway with authorities within the framework of the Sakigake designation system

Sakigake
designation

In-person advice
and preliminaryinterviews

Comprehensive
Sakigake evaluation
consultation

Productapprovalfiling

Review

In-person advice andpreliminary interviews

Product approval••

Regulatory agencies provide guidance and advice in
response to requests from SanBio

Comprehensive Sakigake
evaluation consultation•

Product approval filing will be approved when theauthority determines that the review following thesubmission of the filing can be completed within 6monthsApprovalDrug
pricelisting

Sales

Aiming for early launch by making use of theconditional and time-limited approval system*

NHI drug price listing• Price is calculated using either the comparable drug
method or the cost calculation method, but the method
to be used is currently undetermined

Sales
•

Preparation underway to promptly market the productafter NHI Drug Price listing

The Pharmaceutical and Medical Devices Law, which came into effect on November 25, 2014, introduced an early approval system (approval withconditions and time limits). For regenerative medicine products that are not homogeneous, if safety can be confirmed and efficacy is presumed, thesystem allows approval for manufacturing and sales with conditions and time limits (from Article 23-26 of the Pharmaceutical and Medical DevicesLaw).
©2021 SanBio Company Limited

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Consultations Underway with Authorities for SB623 under the Sakigake System
Priority handling of Sakigake-designated products* and points to note
*Pharmaceuticals, medical devices, in-vitro diagnostic products, regenerative medicine products

Priority consultation(two months→one month)

Sakigake-designated products can receive priority consultation, including in-person advice, from PMDA, withhigher priority compared to other (non-designated) pharmaceuticals, medical devices, in-vitro diagnostic
products, and regenerative medicine products.

Enhanced prior assessment(essentially a review before
approval filing)

Sakigake-designated products are expected to proactively utilize the Sakigake System prior to filing for
approval, to shorten the time between approval filing and approval. In principle, sponsors or developers ofdesignated products are expected to consult concierges (see below) and use all consultation categoriesavailable under the Sakigake comprehensive evaluation provided by PMDA, from the time the products weregranted the designation until approval filing.
Note that if prior assessment under the Sakigake comprehensive evaluation is inadequate (including cases
in which data necessary for assessment were insufficient or actions taken to address or resolve issues
raised by PMDA were inadequate), the time it takes from approval filing till approval may individually bedetermined based on assessment status of designated pharmaceuticals, medical devices, etc.

Priority review(12 months→six months)

Sakigake-designated products receive priority review as they are considered to “fulfill particularly highmedical needs” as provided in Article 23-2-5, Paragraph 10 and Article 23-25, Paragraph 7 of thePharmaceuticals and Medical Devices Act.

Review partner system(PMDA’s concierge)

A person nominated by PMDA as deemed appropriate for coordinating communication with MHLW andPMDA will consult on the development progress management of designated products, and will coordinate
with the sponsors/developers of designated products and reviewing authorities.

Note: With the 2019 revision of the Pharmaceuticals and Medical Devices Act, the Sakigake System (initially implemented as a pilotprogram) has been enacted into law.
©2021 SanBio Company Limited

Source: MHLW homepage

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Products Approved under the Sakigake Designation System➢

MHLW calls for applications for Sakigake designation, and grants designation upon review and assessment ofsubmitted products. Since the program’s launch in 2015, calls for applications were made annually* 1, and as of June
2021, 52 products were granted Sakigake designation.

➢As of June 2021, all 17 products*2 that had filed for approval had been approved.

➢Including SB623, 12 regenerative medicine products were granted the designation, and as of June 15, 2021, two had
been approved under the framework of the Sakigake System (Nipro Corp.’s Stemirac and Dainichi Sankyo’s Delytact).
Designatedproducts
No information
provided

Information
providedApproval filing
unconfirmed *3*4

Cancelled

Approval application filed

Of which,approved

Total(pharmaceuticals, medical devices, invitro diagnostic products, regenerative
medicine products)

5213391751717Of which, regenerative medicine products

121119022

Source: SanBio, based on disclosed materials of MHLW, PMDA (homepage), and companies of designated products*1: Sakigake System, initially implemented as a pilot program, was enacted into law with the 2019 revision of the Pharmaceuticals and Medical Devices Act.
*2: Does not include AVXS-001 (product name: Zolgensma), for which approval application had been filed and approval obtained (March 2020) without using the Sakigake
System in effect, despite the product having received the designation.
*3: Products for which expected approval filing dates are disclosed on respective company websites, but whether approval application had been filed could not be confirmed.
*4: AVX-001, for which approval application had been filed without using the Sakigake System in effect, is included in the “Approval filing unconfirmed” category.

©2021 SanBio Company Limited8

Looking Ahead after SB623 Approval

Status of sales infrastructure development••

Preparations are underway to establish a sales infrastructure complying with expected approval requirements(post-marketing surveillance and promotion of appropriate use).
In collaboration with various external stakeholders, , SanBio is establishing a sales infrastructure to promptly
identify and support TBI patients after launch.
Current status
Pricing
Medical fees

Build a sales
infrastructure

Prepare detailed materials to negotiate appropriate drug prices

Address issues to establish medical fees for surgical procedures for injecting SB623 and cell preparation
procedures
Devise strategies to promote appropriate use by region with a focus on patient follow-up (based on actual
treatment situations)
Establish a CRM system to promote appropriate use

Establish a
distribution system

Prepare to adopt R-SAT® system after launch (including the specifics)

Create promotional
materials

Create materials and video content to provide necessary information after launch

Establish a distribution scheme for each region

Create online content for products and diseases
Draft personnel and facility requirements to promote appropriate use

Develop a system
for appropriate use

Select a vendor to develop a system for determining patient eligibility using ICTCreate various materials necessary for post-launch promotion of appropriate use©2021 SanBio Company Limited

9Progress in Establishing R-SAT® System
As of September 2021*• Trademark registered for R-SAT in August 2020
• Joint patent application by Suzuken and SanBio pending (management system for regenerative
medicine products, and management method for regenerative medicine products)

R-SAT®
Distribution management
system for regenerative
medicine products
Regenerative Medicine
SafetyAccuracy
Traceability

Distribution
schedule

Product traceability

Linking product lot
number with patient

Can be linked

Post-administration
checkup reminders

Temperaturelogger & GPS

Area of joint
development*In August 2019, SanBio concluded a basic agreement with Suzuken for commercial distribution of regenerative medicine
products, and began joint development of R-SAT.

©2021 SanBio Company Limited

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SB623 Development Plans
Highest priority given to TBI program in Japan, followed by clinical trials for ischemic strokeand hemorrhagic stroke programs in Japan.
Top priority

Preparing for
approval filing

Considering timing forstarting clinical trials*

Ischemic stroke

Plan to consult PMDA
on initiating clinical trials

Planning forclinical trials*

Hemorrhagic stroke

Plan to consult PMDA
on initiating clinical trials

Planning forclinical trials*

Traumatic brain injury(TBI)*Considering various options, including in-house development and tie-ups with other companies©2021 SanBio Company Limited

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Development Status
CellmedicineIndication
Traumatic brain injury(TBI)

SB623
Chronic brain Ischemic stroke
injuryHemorrhagic stroke
SB623
Retinaldisease

ResearchNonclinical

Phase 1

Phase 2Phase 3Japan
U.S.
Planning for Phase 2b or 3 study (Japan)*1
Planning for Phase 2b or 3 study (Japan)*1

Age-related macular degeneration(dry)*2Partnered with OcuMension Therapeutics in Greater China

Retinitis pigmentosa*2

Partnered with OcuMension Therapeutics in Greater China

Parkinson’s disease
SB623

Spinal cord injury

Alzheimer’s disease
SB618Peripheral nerve damage, etc.

SB308

Muscular dystrophy

MSC1Cancer
Inflammatory disease

MSC2

Optic neuritis *2

Partnered with OcuMension Therapeutics in Greater China*1: Clinical trials will begin from Phase 2b as safety has been confirmed in previous clinical trials for ischemic stroke and TBI programs.
*2: Joint development with OcuMension (Hong Kong) Limited.
©2021 SanBio Company Limited

12Becoming a Global Leader in Regenerative Medicine

Deliver novel therapeutics to patients as rapidly as possible
and maximize corporate value©2021 SanBio Company Limited

133. Q&A

©2021 SanBio Company Limited

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Disclaimer

This presentation material, including any comments made during or following the presentation, isprovided solely for the purpose of reference to those investors who make their own evaluation of
the company at their own risk. This material contains estimates, such as plans, strategies andjudgments, that are forward-looking statements which are made based on management’s
assumptions and beliefs in light of the information currently available to it, and may contain risks
and uncertainty. Therefore you should not place undue reliance on them in making investment
decisions.
SanBio cautions you that actual results may differ substantially from those discussed in thismaterial due to various factors. We do not guarantee the accuracy or completeness of theinformation herein. Unless otherwise stated, estimates or forecasts are solely those of ourcompany and subject to change without notice. We accept no liability whatsoever for any direct orconsequential loss arising from any use of this report.
SanBio Company Limited
Management Administration
Contact: info@sanbio.jp©2020 SanBio Company Limited

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