Summary of Consolidated Financial Statements
for the First Three Months of Fiscal Year Ending December 31, 2023
[Japanese GAAP]
April 27, 2023
Company Name

SymBio Pharmaceuticals Limited

Listing: Tokyo Stock Exchange

Securities Code4582

URL: https://www.symbiopharma.com/

Representative

Representative Director,
President and Chief Executive Officer

Fuminori Yoshida

Contact Person

Executive Corporate Officer andChief Financial Officer

Takaaki Fukushima

TEL +81-3-5472-1125

Date of Dividend
Payment (plan)–

Scheduled Date to File Quarterly April 28, 2023
ReportSupplementary materials for the quarterly financial statements:

Yes ・ No

Holding of quarterly earnings performance review:

Yes ・ No

(Amounts of less than one million yen are rounded down.)
1. Business Results for the First Three Months of FY 2023 (January 1, 2023 to March 31, 2023)(1) Consolidated Operating Results (cumulative)(Percentages indicate year-on-year changes.)
Net Sales
Q1 FY 2023
Q1 FY 2022

Operating Profit

Profit attributable toowners of parent

Ordinary Profit

Millions of yen%

Millions of yen%

Millions of yen%

Millions of yen

%

1,544
2,315

(33.3)–

51509(89.9)–

48
478(89.9)–

4
163(97.3)–(Note) Comprehensive income:Q1 FY 2023
Q1 FY 2022

Earnings per ShareQ1 FY 2023
Q1 FY 2022

4 million yen [(97.2)%]
163 million yen [ – %]Diluted Earnings per Share
Yen

Yen

0.11
4.25

0.11
4.18

(2) Consolidated Financial Position
Total Assets
Q1 FY 2023 (as of March 31, 2023)
FY 2022 (as of December 31, 2022)(Reference) Shareholders’ equity:

Net Assets

Equity Ratio

Millions of yen

Millions of yen

%

9,356
10,433

8,533
8,506

87.0
77.6

Q1 FY 2023 (as of March 31, 2023)
FY 2022 (as of December 31, 2022)

8,139 million yen
8,094 million yen

2. Dividends
Annual Dividend per ShareFY 2022
FY 2023
FY 2023 (Forecast)

1st QuarterYen

2nd Quarter
Yen

3rd Quarter
Yen

Fiscal Year End
Yen

–
–

0.00

–

0.00

0.00

0.00

–

0.00

0.00

(Note) Revision of dividend forecasts most recently announced: Yes ・ No

Full YearYen

3. Earnings Forecasts for FY 2023 (January 1, 2023 to December 31, 2023)
Operating Profit(Loss)Net Sales
Millions of yen

Full Year

7,000% Millions of yen(30.1)(331)(Percentages indicate year-on-year changes.)
Profit (Loss)
Earnings (Loss) per
attributable toShareowners of parent

Ordinary Profit(Loss)% Millions of yen% Millions of yen

%

Yen

–

–

–

(9.48)

(351)

(370)

(Note) Revision of earnings forecasts most recently announced: Yes ・ No
Notes:(1) Changes in significant subsidiaries during the period:(Transfer of specified subsidiary accompanying a change in the scope of consolidation)
New: None
Removed: None

Yes ・ No

(2) Application of special accounting treatment in preparing the quarterly financial statements: Yes ・ No
(3) Changes in accounting policies, changes in accounting estimates and restatements after error corrections(a) Changes in accounting policies due to revision of accounting standards:

Yes ・ No(b) Changes in accounting policies due to other reasons:Yes ・ No(c) Changes in accounting estimates:

Yes ・ No(d) Restatements after error corrections:

Yes ・ No

(4) Number of issued shares (common stock)(i) Total number of issued shares at the end of
the period (including treasury shares)

Q1 FY 2023

39,693,656 shares

FY 2022

39,603,606 shares(ii) Total number of treasury shares at the endof the period

Q1 FY 2023

85,844 shares

FY 2022

85,268 shares

Q1 FY 2023

39,530,266 shares(iii) Average number of shares during theperiod (cumulative)

Q1 FY 2022

38,392,424 shares* Summary of the quarterly financial statements is not subject to quarterly reviews by certified public accountants or accounting
corporations.
* Explanation regarding the appropriate use of earnings forecasts and other matters
All forecasts presented in this document, including earnings forecasts, are based on the information currently available to theCompany and assumptions determined by the Company to be reasonable. Actual results may differ substantially from these
forecasts due to various factors. Regarding the assumptions on which the Company’s earnings forecasts are based and their usage,
please refer to “1. Qualitative Information on Quarterly Financial Results (3) Explanation of consolidated earnings forecast andother forward-looking information” on Page 4 of the attachment.

Index of the attachment
1. Qualitative Information on Quarterly Financial Results ........................................................................................................................ 2(1) Business results ................................................................................................................................................................................ 2(2) Summary of financial position ......................................................................................................................................................... 4(3) Explanation of consolidated earnings forecasts and other forward-looking information ................................................................. 4
2. Quarterly Consolidated Financial Statements and Primary Notes ......................................................................................................... 5(1) Quarterly consolidated balance sheet ............................................................................................................................................... 5(2) Quarterly consolidated statement of income and consolidated statement of comprehensive income ............................................... 7
Quarterly consolidated statement of income for the first three months of FY 2023 ......................................................................... 7
Quarterly consolidated statement of comprehensive income for the first three months of FY 2023 ................................................ 8(3) Notes to quarterly consolidated financial statements ....................................................................................................................... 9(Notes to going concern assumptions).............................................................................................................................................. 9(Notes in case of significant changes to shareholders’ equity) ......................................................................................................... 9(Accounting policy changes) ............................................................................................................................................................ 9(Significant subsequent events) ...................................................................................................................................................... 10―1―

1. Qualitative Information on Quarterly Financial Results(1) Business results
Progress in the Company’s business for the first three months of the fiscal year under review is as follows.
(i) Business results for the period under review
In December 2020, the Group began selling TREAKISYM® (generic name: bendamustine hydrochloride or bendamustinehydrochloride hydrate) through its own sales organization.
The Group has established a highly productive salesforce consisting of qualified medical representatives nationwide. As our
medical representatives have expertise in hematology and are deployed nationally, they are capable of effectively addressing the
local needs of institutions in each region in the country. To achieve nationwide distribution, we have entered into distributionagreements with Suzuken Co., Ltd. and Toho Pharmaceutical Co., Ltd. We are also working with S.D. Collabo Co., Ltd. and haveestablished two logistics centers, one in eastern and one in western Japan.
In February 2022, the Group obtained approval for a partial change to the marketing authorization of the ready-to-dilute (RTD)
liquid formulation of TREAKISYM® to add rapid infusion (RI) administration. The RTD formulation of TREAKISYM® is a liquid
formulation that eliminates the need for manual reconstitution and significantly reduces preparation time. RI administration has thefurther advantage of reducing the infusion time to 10 minutes, benefiting both patients and healthcare providers. In addition, thereduction in infusion volume of RI means a lower volume of saline solution and accordingly the amount of water and salt (sodium
chloride) used.
Conversion to the RI administration proceeded smoothly, with over 80% of medical institutions switching to RI administration asof the end of March 2023.
Net sales of TREAKISYM® for Q1 totaled 1,544,813 thousand yen (-33.3% year on year), impacted by postponed purchases in
anticipation of NHI price revision, continuing downward trend in drug usage per case with the COVID-19 pandemic, the impact ofgeneric bendamustine products launched in June 2022, and the temporary sales increase in the same period last year due to theincrease in distribution inventory following the switch from freeze-dried (FD) to RTD.
Selling, general and administrative expenses totaled 1,192,011 thousand yen (-14.2% year on year). This amount includes researchand development expenses of 549,848 thousand yen (+10.8% year on year).
As a result, operating profit was 51,246 thousand yen (versus 509,200 thousand yen for the same period in FY 2022) and ordinary
profit was 48,326 thousand yen (versus 478,616 thousand yen for the same period in FY 2022). Profit attributable to owners of parent
amounted to 4,455 thousand yen (versus 163,171 thousand yen for the same period in FY 2022).
In February 2022, generic bendamustine products were approved for manufacturing and marketing in Japan. Given the potential
infringement of the patents related to TREAKISYM® in Japan which are exclusively licensed to the Company from Eagle
Pharmaceuticals, Inc (head office: New Jersey, U.S.; hereinafter “Eagle”), the Company in coordination with Eagle notified four
generic makers of potential patent infringement and, in December 2022, commenced litigation against the makers of the genericproducts, Pfizer Japan Inc. (head office: Tokyo) and Towa Pharmaceutical Co., Ltd. (head office: Osaka), seeking an injunction
against the manufacture and sale of the products and compensation for damages arising from the infringement.
Segment information has been omitted as the Group operates within a single segment, which includes the research anddevelopment, manufacturing, and marketing of pharmaceutical drugs and other related activities.
(ii) Research and development activities
During the first three months of FY 2023, we conducted the following research and development activities.
(a) Anticancer agents: SyB L-0501 (FD formulation), SyB L-1701 (RTD formulation), and SyB L-1702 (RI administration)(generic name: bendamustine hydrochloride or bendamustine hydrochloride hydrate, trade name: TREAKISYM®)
For the RI administration, a partial change application was approved in February 2022, enabling the use of RI injection for all
approved indications of the RTD formulation in-licensed from Eagle.
The Group continues to actively conduct further research on TREAKISYM®, such as ongoing joint research with Kyoto
University, to explore new possibilities of the drug.

―2―(b) Anticancer agents: SyB L-1101 (intravenous formulation) and SyB C-1101 (oral formulation) (generic name: rigosertib
sodium)For rigosertib in-licensed from Onconova Therapeutics, Inc. (head office: Pennsylvania, U.S.), the Group is collaborating with
the University of Tokyo to conduct research to identify new potential indications or applications for the drug either alone or in
combination with other existing drugs (including bendamustine).
(c) Antiviral drug: SyB V-1901 (generic name: brincidofovir [BCV])The Group obtained the exclusive license to brincidofovir from Chimerix Inc. (head office: North Carolina, U.S.; hereinafter“Chimerix”) in September 2019. In September 2022, Emergent BioSolutions Inc. (head office: Maryland, U.S.) completed its
acquisition of the exclusive worldwide rights to brincidofovir from Chimerix. The Group’s exclusive worldwide license to develop,
manufacture, and market BCV for all indications except orthopox virus infections (including smallpox and monkeypox) will not
be affected.
The Group prioritizing global development of BCV (primarily in Japan, the U.S., and Europe), targeting disseminated adenovirus(AdV) infections occurring after hematopoietic stem cell transplantation. In March 2021, the Group filed an Investigational New
Drug (IND) application with the FDA to conduct a Phase II clinical trial in patients (primarily pediatric but also adults) sufferingfrom AdV infections. This development program was granted Fast Track designation by the FDA in April 2021. As of March 31,
2023, 22 patients were enrolled.
In addition, the Group submitted a clinical trial notification for a Phase II study in patients infected with BK virus (BKV)
infection after kidney transplantation to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan in May 2022 and filed
another notification with the Therapeutic Goods Administration (TGA) of Australia in August 2022. BKV infection after kidneytransplantation is a disease with serious consequences for the recipient, the donor, the medical practitioner, and society, due to therisk of impaired renal function and loss of the transplanted kidney (graft loss). The investigational drug was administered to thefirst subject in December 2022.
In light of the drugs’ broad effectiveness against double-stranded DNA (dsDNA) viruses, the Group is also collaborating withleading research institutions both in Japan and overseas to study BCV’s potential use in the treatment of various other diseases.
Among dsDNA viruses, polyomaviruses are known to cause serious diseases through their infection. As existing antiviral drugs
show little efficacy, there is a high level of medical need for the development of an effective treatment. In November 2022, theGroup entered into Material Transfer Agreement with Penn State College of Medicine whereby the Group will provide BCV for
use in a non-clinical study to evaluate the efficacy of BCV in a mouse model of polyomavirus infection.
In addition to having its strong antiviral effect, BCV also is expected to have an antitumor effect, and the Group is exploring
BCV’s potential in indications such as EBV-positive lymphoma, refractory brain tumors, and other cancers, through researchcollaborations with the National Cancer Centre Singapore (NCCS) and the University of California San Francisco (UCSF) Brain
Tumor Center. In December 2022, the results of collaborative research with NCCS on the therapeutic efficacy of BCV in thetreatment of NK/T-cell lymphoma, for which no effective treatment is currently available, were presented by Dr. Jason Chan at the64th American Society of Hematology (ASH) Annual Meeting in New Orleans.
The Group is also investigating the use of BCV to treat multiple sclerosis, an intractable disease that has recently been shown to
be associated with Epstein-Barr virus (EBV). In August 2022, the Company entered into a collaboration agreement with the
National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health (NIH) in the U.S., forthe transfer of materials to evaluate the antiviral effect of BCVin EBV. In March 2023, The Company has entered into a Cooperative
Research and Development Agreement (CRADA) for BCV with NINDS. The purpose of the CRADA is to verify the efficacy of
BCV as an anti-viral therapeutic for EBV in the treatment of multiple sclerosis, and to obtain necessary data with a view to future
clinical trials. In April 2023, the Company entered into a CRADA with the National Institute of Allergy and Infectious Diseases(NIAID), part of NIH in the U.S., to investigate the efficacy of BCV in the treatment of EBV associated lymphoproliferative
diseases.
Some dsDNA viruses, such as HSV1 and VZV, are directed against cranial nerve tissues. In recent years, research has advancedon the involvement of the reactivation of those viruses in various serious diseases of the nervous system, including Alzheimer's
disease. In December 2022, the Group entered into a Sponsored Research Agreement with Tufts University to conduct research toevaluate the efficacy of BCV in a herpes simplex virus (HSV) infection model using a 3D (three-dimensional) brain model
established by Tufts University.

―3―

(iii) Business outside Japan
In 2022, the Group appointed Dr. Carolyn Yanavich, President and Chief Operating Officer of SymBio Pharma USA, Inc., as
Chief Development Officer, to further expand the Group’s global development structure and make SymBio Pharma USA, Inc. thedriving force for our international clinical trials as we move forward with our global development plan for BCV.
(iv) Licensing of new drug candidates
The Group continues to evaluate promising new drug candidates for in-licensing. Through these efforts, the Group aims to create
medium-to long-term business value.

(2) Summary of financial position
Total consolidated assets as of March 31, 2023, stood at 9,356,741 thousand yen. Current assets totaled 8,302,192 thousand yen,mainly consisting of 5,939,570 thousand yen in cash and deposits, 1,334,011 thousand yen in accounts receivable-trade, 386,831
thousand yen in merchandise and finished goods, and 168,578 thousand yen in semi-finished goods. Non-current assets were 1,054,548
thousand yen, mainly consisting of 701,908 thousand yen in deferred tax assets and 201,453 thousand yen in software.
Total liabilities were 823,181 thousand yen. Current liabilities totaled 819,505 thousand yen, mainly consisting of 529,672 thousand
yen in accounts payable-other. Non-current liabilities were 3,676 thousand yen, consisting of 3,676 thousand yen in liabilities for
retirement benefits.
Total net assets stood at 8,533,560 thousand yen. This includes 17,568,878 thousand yen in capital stock, 17,543,776 thousand yen
in capital surplus, and 394,087 thousand yen in share acquisition rights.
As a result, the equity ratio was 87.0%.

(3) Explanation of consolidated earnings forecasts and other forward-looking information
No revision was made to the earnings forecasts for FY 2023 as of the date of this document.

―4―

2. Quarterly Consolidated Financial Statements and Primary Notes(1) Quarterly consolidated balance sheet(Unit: thousands of yen)
FY 2022(as of December 31, 2022)

Q1 FY 2023
(as of March 31, 2023)

AssetsCurrent assets
Cash and deposits
Accounts receivable–trade
Merchandise and finished goods
Semi-finished goods
Prepaid expenses
Other
Total current assets

6,282,554

5,939,570

2,084,915
293,757

1,334,011
386,831

175,170
209,886

168,578
198,033

266,422275,167

9,312,706

8,302,192

Non-current assets
Property, plant and equipment
Buildings, net

40,67039,59428,33969,00925,631

Software
Software in progress

222,204

201,453–

1,597

Total intangible assets

222,204

203,050

744,728
84,698

701,908
84,363

829,427
1,120,641

786,271
1,054,548

10,433,347

9,356,741

46,633
1,163,721

68,015
529,672

401,066
16,33153,531–

296,118

168,285

1,923,870

819,505

3,385

3,676

3,385
1,927,255

823,181

Tools, furniture and fixtures, net
Total property, plant and equipment

65,226

Intangible assets

Investments and other assets
Deferred tax assets
Leasehold and guarantee deposits
Total investments and other assets
Total non-current assets
Total assets
Liabilities
Current liabilities
Accounts payable–trade
Accounts payable–other
Income taxes payable
Provision for product changeover
Other
Total current liabilities
Non-current liabilities
Liabilities for retirement benefits
Total non-current liabilities
Total liabilities

―5―

3,676

(Unit: thousands of yen)
FY 2022(as of December 31, 2022)

Q1 FY 2023
(as of March 31, 2023)

Net assets
Shareholders’ equity
17,548,459

17,568,878

17,523,357(28,889,486)

17,543,776(26,885,030)(88,154)(88,470)

8,094,176

8,139,154

Foreign currency translation adjustment

243

318

Total accumulated other comprehensive income

243

318

Share capital
Capital surplus
Retained earnings
Treasury shares
Total shareholders’ equity
Accumulated other comprehensive income

Share acquisition rights
Total net assets
Total liabilities and net assets―6―

411,672

394,087

8,506,092

8,533,560

10,433,347

9,356,741

(2) Quarterly consolidated statement of income and consolidated statement of comprehensive income
Quarterly consolidated statement of income for the first three months of FY 2023
Q1 FY 2022
(from January 1, 2022
to March 31, 2022)
Net sales(Unit: thousands of yen)
Q1 FY 2023
(from January 1, 2023
to March 31, 2023)
1,544,813
301,555

Gross profit

2,315,992
417,901
1,898,090

Selling, general and administrative expenses

1,388,889

1,192,011

509,200

51,24622

Cost of sales

Operating profit (loss)

1,243,257

Non-operating income
Interest income
Foreign exchange gains

17,010142
2,992

Total non-operating income

17,032

3,135

47,319
298

5,712
343

Non-operating expenses
Commission expenses
Share issuance costs

47,617

6,055

478,616

48,326–2,496–
478,616

50,823

Income taxes - deferred

76,119239,325

3,547
42,820Total income taxes

315,444

46,367

Profit163,171

4,455

Profit attributable to non-controlling interests–
163,171–

Total non-operating expenses
Ordinary profit
Extraordinary income
Gain on reversal of share acquisition rights
Total extraordinary income
Profit before income taxes
Income taxes - current

Profit attributable to owners of parent

―7―

2,496

4,455

Quarterly consolidated statement of comprehensive income for the first three months of FY 2023

163,171(Unit: thousands of yen)
Q1 FY 2023
(from January 1, 2023
to March 31, 2023)
4,455

239

75

Q1 FY 2022
(from January 1, 2022
to March 31, 2022)
ProfitAccumulated other comprehensive income
Foreign currency translation adjustment
Total other comprehensive income
Comprehensive income

239

75

163,410

4,531

163,410

4,531

–

–

Comprehensive income attributable toComprehensive income attributable to owners of parent
Comprehensive income attributable to non-controllinginterests―8―

(3) Notes to quarterly consolidated financial statements(Notes to going concern assumptions)None to be reported.
(Notes in case of significant changes to shareholders’ equity)
In the first three months of FY 2023, the Company issued new shares due to the exercise of some of share acquisition rights
pertaining to the 44th, 49th, 52nd, and 53rd warrants. As a result, share capital and capital surplus each increased by 20,419 thousand
yen. The total value of treasury shares increased 315 thousand yen as a result of share repurchases.
As a result, as of March 31, 2023, consolidated share capital was 17,568,878 thousand yen, capital surplus was 17,543,776
thousand yen, and the total value of treasury shares was 88,470 thousand yen.
(Accounting policy changes)
The Company has applied the “Accounting Standard for Fair Value Measurement” (ASBJ Statement No. 31; June 17, 2021;
hereinafter “Fair Value Measurement Standard”) from the beginning of the first three months of FY 2023.
In applying the Fair Value Measurement Standard, the Company has followed the transitional treatment prescribed in thetransitional measures provided for in paragraph 27-2 of the Implementation Guidance on Accounting Standard for Fair Value
Measurement and will apply the new accounting standard prescribed by the Fair Value Measurement Standard, prospectively.
The adoption of this accounting standard has no effect on the quarterly consolidated financial statements.

―9―

(Significant subsequent events)
1. Issuance of the 59th warrant (stock options)On April 14, 2023, the Company issued and granted share acquisition rights in the form of stock options to four directors(excluding directors who are Audit & Supervisory Committee Members) as indicated below. This issuance of share acquisitionrights was pursuant to a resolution approved by the Board of Directors on March 23, 2023.
Number of share acquisition rights

3,160 units

Class and number of shares to be issued upon the exercise ofshare acquisition rights

79,000 common shares

Issue price of share acquisition rights and total issue amountIssue price: 11,000 yen
Total issue amount: 34,760,000 yen

Amount to be paid in for share acquisition rights

Amount to be paid in per share: 440 yen
As the amount to be paid for the stock acquisition rights isprovided to the recipient in lieu of compensation, each
recipient is required to waive his or her claim to thecorresponding amount of compensation against theCompany.

Exercise price of share acquisition rights

Exercise price per share: 1 yen

Exercise period of share acquisition rights

From March 24, 2026 to March 23, 2033

Conditions for the exercise of share acquisition rights

Increase in share capital in case of the issuance of sharesthrough the exercise of share acquisition rights

Matters regarding transfer of share acquisition rights(1) Individuals to whom these share acquisition rights are
granted must hold a position as a director or employee of
the Company or with an affiliate to exercise these rights.
However, this will not apply to directors at the Company
or its affiliates who have left their positions due to expiryof their terms of offices, employees at the Company or its
affiliates who have retired as a result of reachingretirement age or directors or employees at the Company
or its affiliates who have been deemed to have left theirpositions or retired amicably by the Board of Directors.
(2) Other conditions will be established in the Share
Acquisition Rights Allocation Agreement concluded
between the Company and the employees.
Increase in share capital related to the issuance of sharesthrough the exercise of share acquisition rights shall equal toone half of the maximum amount by which share capital canbe increased as calculated in accordance with Article 17 of
the Ordinance on Company Accounting. Any fraction lessthan one yen shall be rounded up to the nearest one yen.
Transfers will require approval from the Board of Directors.

―10―

2. Issuance of the 60th warrant (stock options)On April 14, 2023, the Company issued and granted share acquisition rights in the form of stock options to 110 employees as
indicated below. This issuance of share acquisition rights was based on a resolution by the Board of Directors on March 23, 2023.
Number of share acquisition rights

10,801 units

Class and number of shares to be issued upon the exercise ofshare acquisition rights

270,025 common shares

Issue price of share acquisition rights and total issue amountIssue price: 11,000 yen
Total issue amount: 118,811,000 yen

Amount to be paid in for share acquisition rights

Exercise price per share: 440 yen
As the amount to be paid for the stock acquisition rights isprovided to the recipient in lieu of compensation, each
recipient is required to waive his or her claim to thecorresponding amount of compensation against theCompany.

Exercise price of share acquisition rights

Exercise price per share: 1 yen

Exercise period of share acquisition rights

From March 24, 2026 to March 23, 2033

Conditions for the exercise of share acquisition rights

Increase in share capital in case of the issuance of sharesthrough the exercise of share acquisition rights

Matters regarding transfer of share acquisition rights(1) Individuals to whom these share acquisition rights are
granted must hold a position as a director or employee of
the Company or with an affiliate to exercise these rights.
However, this will not apply to directors at the Company
or its affiliates who have left their positions due to expiryof their terms of offices, employees at the Company or its
affiliates who have retired as a result of reachingretirement age or directors or employees at the Company
or its affiliates who have been deemed to have left theirpositions or retired amicably by the Board of Directors.
(2) Other conditions will be established in the Share
Acquisition Rights Allocation Agreement concluded
between the Company and the directors.
Increases in share capital related to the issue of shares throughthe exercise of share acquisition rights shall be equal to one
half of the maximum amount by which share capital can beincreased as calculated in accordance with Article 17 of theOrdinance on Company Accounting. Any fraction less than
one yen shall be rounded up to the nearest one yen.
Transfers will require approval from the Board of Directors.

―11―