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    4592   JP3336750009

SANBIO COMPANY LIMITED

(4592)
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SanBio : Consolidated Financial Results for the Six Months Ended July 31, 2021

09/14/2021 | 05:32am EDT

Consolidated Financial Results

for the Six Months Ended July 31, 2021

[Japanese GAAP]

September 14, 2021

Company name: SanBio Company Limited

Stock exchange listing: Tokyo Stock Exchange

Code number: 4592

URL: https://www.sanbio.com/

Representative: Keita Mori, Representative Director and President

Contact: Yoshihiro Kakutani, Corporate Officer of Management Administration

Phone: +81-3-6264-3481

Scheduled date of filing quarterly securities report: September 14, 2021

Scheduled date of commencing dividend payments: -

Availability of supplementary briefing material on financial results: No

Schedule of financial results briefing session: Yes (for institutional investors and analysts)

(Amounts of less than one million yen are rounded down.)

1. Consolidated Financial Results for the Six Months Ended July 31, 2021 (February 1, 2021 to July 31,

2021)

(1) Consolidated Operating Results

(% indicates changes from the previous corresponding period.)

Net income

Operating revenue

Operating income

Ordinary income

attributable to

owners of parent

Six months ended

Million yen

%

Million yen

%

Million yen

%

Million yen

%

July 31, 2021

-

-

(3,052)

-

(2,146)

-

(2,134)

-

July 31, 2020

-

-

(2,570)

-

(3,205)

-

(3,207)

-

(Note) Comprehensive income: Six months ended July 31, 2021: ¥(2,845) million [-%] Six months ended July 31, 2020: ¥(1,961) million [-%]

Net income

Diluted net income

per share

per share

Six months ended

Yen

Yen

July 31, 2021

(41.21)

-

July 31, 2020

(61.94)

-

(Note) Diluted net income per share is not stated as net loss per share was recorded although there are potential shares with dilutive effect.

(2) Consolidated Financial Position

Total assets

Net assets

Equity ratio

Net assets per share

Million yen

Million yen

%

Yen

As of July 31, 2021

9,709

5,552

54.5

102.18

As of January 31, 2021

13,343

8,349

61.0

157.07

(Reference) Equity: As of July 31, 2021: ¥5,291 million As of January 31, 2021: ¥8,133 million

2. Dividends

Annual dividends

1st

2nd

3rd

Year-end

Total

quarter-endquarter-endquarter-end

Yen

Yen

Yen

Yen

Yen

Fiscal year ended January 31, 2021

-

0.00

-

0.00

0.00

Fiscal year ending January 31, 2022

-

0.00

Fiscal year ending January 31, 2022 (Forecast)

-

0.00

0.00

(Note) Revision to the forecast for dividends announced most recently: No

3. Consolidated Financial Results Forecast for the Fiscal Year Ending January 31, 2022 (February 1, 2021 to January 31, 2022)

(% indicates changes from the previous corresponding period.)

Operating

Operating

Net income

Net income

Ordinary income

attributable to

revenue

income

per share

owners of parent

Million yen

%

Million yen

%

Million yen

%

Million yen

%

Yen

Full year

-

-

(5,786)

-

(5,876)

-

(5,877)

-

(113.49)

(Note) Revision to the financial results forecast announced most recently: No

Notes:

  1. Changes in significant subsidiaries during the period under review (changes in specified subsidiaries resulting in changes in scope of consolidation): No
  2. Accounting policies adopted specially for the preparation of quarterly consolidated financial statements: No
  3. Changes in accounting policies, changes in accounting estimates and retrospective restatement
    1. Changes in accounting policies due to the revision of accounting standards: No
    2. Changes in accounting policies other than 1) above: No
    3. Changes in accounting estimates: No
    4. Retrospective restatement: No
  4. Total number of issued shares (common shares)
  1. Total number of issued shares at the end of the period (including treasury shares): July 31, 2021: 51,787,073 shares
    January 31, 2021: 51,785,505 shares
  2. Total number of treasury shares at the end of the period:

July 31, 2021: 196 shares

January 31, 2021: 196 shares

3) Average number of shares during the period:

Six months ended July 31, 2021: 51,786,782 shares

Six months ended July 31, 2020: 51,784,931 shares

*These quarterly financial results are outside the scope of quarterly review by a certified public accountant or an

audit corporation.

* Explanation of the proper use of the financial results forecast and other notes

The earnings forecasts and other forward-looking statements herein are based on information available to the Company at the time of preparation and certain assumptions deemed to be reasonable, and the Company does not assure the achievement of any of these. Furthermore, actual results may vary significantly due to various factors. For the assumptions and notes for earnings forecasts, please refer to "1. Qualitative Information on Quarterly Financial Results for the Period under Review, (3) Explanation of Consolidated Financial Results Forecast and Other Forward- looking Information" on page 4 of the attachment.

Table of Contents

1. Qualitative Information on Quarterly Financial Results for the Period under Review .......................

2

(1)

Explanation of Operating Results ...................................................................................................

2

(2)

Explanation of Financial Position ...................................................................................................

3

(3) Explanation of Consolidated Financial Results Forecast and Other Forward-looking Information . 4

2. Quarterly Consolidated Financial Statements and Primary Notes ......................................................

5

(1)

Quarterly Consolidated Balance Sheets ..........................................................................................

5

(2)

Quarterly Consolidated Statements of Income and Comprehensive Income ..................................

6

Quarterly Consolidated Statements of Income

For the Six Months Ended July 31 .............................................................................................

6

Quarterly Consolidated Statements of Comprehensive Income

For the Six Months Ended July 31 .............................................................................................

7

(3)

Quarterly Consolidated Statements of Cash Flows .........................................................................

8

(4) Notes to the Quarterly Consolidated Financial Statements .............................................................

9

(Notes on going concern assumption) ........................................................................................

9

(Notes in the event of significant changes in shareholders' equity) .............................................

9

1

1. Qualitative Information on Quarterly Financial Results for the Period under Review

(1) Explanation of Operating Results

During the six months ended July 31, 2021 (from February 1, 2021 to July 31, 2021), despite the restraint on economic activities amid the new coronavirus pandemic, the global economy saw a recovery trend mainly in developed countries due to vaccination for the new coronavirus infection and other economic measures. However, the economic recovery has been unpredictable due to the spread of the infection caused by delays in the vaccination as well as the new coronavirus variants. In Japan as well, the preliminary figures for gross domestic product (GDP) for the April-June quarter of 2021 indicated a positive growth for the first time in two quarters, but with a low growth rate.

In the Japanese regenerative medicine industry, amid ongoing promotion of the industry by implementation of the Act on the Safety of Regenerative Medicine and the Revised Pharmaceutical Affairs Act of November 2014, the approval for conditional and time-limited sales was granted for the first time in September 2015 under the new program to accelerate the process of drug approval for regenerative medical products developed in Japan. The accelerated delivery of regenerative medical products to the market is rapidly becoming a reality. In addition, the 21st Century Cures Act was passed in the US in December 2016. Under the new legal system, regenerative medical products will be identified as a new category of advanced medical treatment (Regenerative Medicine Advanced Therapy: RMAT) while the establishment of an approval system and approval of new drugs, pertaining to regenerative medicine-related products, are expected to be accelerated.

In this environment, while aiming at commercialization of its unique regenerative cell medicine, SB623, as a new drug candidate for central nervous system diseases, the Company established SanBio Asia Pte. Ltd., its first subsidiary in Asia outside Japan, in Singapore on February 1, 2021, with a view to expanding sales channels in the Asian region.

Regarding the development status of the Group (hereinafter referring to three companies; the Company, SanBio, Inc. of Mountain View, California, US, and SanBio Asia Pte. Ltd. of Singapore), in the Phase 2 clinical trial involving the SB623 development program for treatment of chronic traumatic brain injury and conducted in the US and Japan with 61 patients, the Group obtained positive results in November 2018 that the "patients treated with SB623 cells demonstrated a statistically significant improvement in their motor function compared to the control group, and primary endpoint was met." In April 2019, the domestic development program for treatment of chronic traumatic brain injury was chosen as a designated regenerative medical product by the Ministry of Health, Labour and Welfare under the SAKIGAKE Designation System. Currently, in Japan, we are actively negotiating with the Pharmaceuticals and Medical Devices Agency (PMDA) within the framework of the SAKIGAKE Designation System, aimed at applying for approval for manufacture and sales of SB623 as a regenerative medical product as early as possible. (For the detailed situation so far, please refer to the Company's press release dated December 15, 2020 entitled "Notice regarding the status of domestic approval filing for regenerative cell medicine SB623 for treatment of chronic effects associated with traumatic brain injury.") Under this system, active discussion is being held preferentially in the preliminary evaluation preceding the application for approval for manufacture and sales of the designated products in order to shorten the examination period after the application. We will continue to hold negotiations with the PMDA toward the earliest possible acquisition of the approval for domestic manufacture and sales of SB623, while steadily proceeding with preparations for establishment of a sales system after obtaining the approval. In addition, as for the SB623 development program for treatment of chronic motor deficit from ischemic stroke ("development program for treatment of chronic stroke"), the Group conducted a Phase 2b clinical trial (STR- 02 trial) in the US with 163 patients demonstrating motor deficits associated with chronic ischemic stroke, and announced in January 2019 that "no statistically significant difference was found in the proportion of patients whose Fugl-Meyer Motor Scale (FMMS) score improved by 10 or more points over the baseline at six months after treatment (the primary endpoint) between the SB623 treatment group and the control group, and thus the trial did not meet the primary endpoint." However, in September 2020, as an additional analysis of STR-02 trial (for details, please refer to the Company's press release dated September 14, 2020 entitled "Additional analytical results of the US-based Phase 2b clinical trial of regenerative cell medicine SB623 for the treatment of chronic motor deficit from

2

This is an excerpt of the original content. To continue reading it, access the original document here.

Disclaimer

SanBio Co. Ltd. published this content on 14 September 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 14 September 2021 09:31:00 UTC.


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Net income 2022 -5 497 M -48,3 M -48,3 M
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P/E ratio 2022 -11,7x
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Managers and Directors
Keita Mori President, CEO & Representative Director
Toru Kawanishi Chairman
Bijan Nejadnik Chief Medical Officer & Executive Officer
Chris sanbio Horan Chief Technical Operations Officer
Akihiro Tsujimura COO, Representative Director & Executive VP
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