Summary of Financial Statements for the Fiscal Year Ended December 31, 2023
[Japanese GAAP] (Consolidated)
February 8, 2024
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 Vice President, Corporate Officer
and Chief Financial Officer

Takaaki Fukushima

TEL +81-3-5472-1125

Ordinary Annual General
Meeting of Shareholders

March 22, 2024

Date of Dividend
Payment (plan)—

Scheduled Date to File
Securities Report

March 22, 2024

Supplementary materials for the financial statements: Yes

No

Holding of earnings performance review:

No (For securities analysts and institutional investors)

Yes(Amounts of less than one million yen are rounded down.)
1. Business Results for FY 2023 (January 1, 2023 to December 31, 2023)(1) Consolidated Operating Results
Net Sales
FY 2023
FY 2022

Operating Profit

Millions of yen

%

5,589
10,008(Note) Comprehensive income:(44.1)－

Millions of yen

FY 2023
FY 2022

Profit attributable toowners of parent

Ordinary Profit
%

(811)
1,963

Millions of yen

(736)
1,999

－
－

%

Millions of yen(1,962)
1,179

－
－

%

－
－

(1,956) million yen ( -%)1,179 million yen ( -%)Earnings per Share

Diluted Earnings per
Share

Yen

Yen

FY 2023
FY 2022(Percentages indicate year-on-year changes.)(49.19)30.20

Ratio of Profit to
Equity (ROE)%

Ratio of Ordinary
Profit to Total Assets(ROA)

Ratio of Operating
Profit to Net Sales

(7.9)
19.2

(14.5)
19.6%(26.1)
14.6

―
29.77

%

(Reference) Equity in net income of affiliated companies:

FY 2023－ million yen
FY 2022－ million yen(Note) The Group began preparing consolidated financial statements from FY 2022 with the start of operations at SymBio Pharma
USA Inc. Return on equity and the ordinary profit rate to total assets for the fiscal year ended December 31, 2022 were calculated on
the basis of the year-end equity and total assets respectively since the fiscal year ended December 31, 2022 is the first fiscal year that
consolidated financial statements were prepared for.
(2) Consolidated Financial Position
Total Assets
FY 2023 (as of December 31, 2023)
FY 2022 (as of December 31, 2022)(Reference) Shareholders’ equity:

Net Assets

Millions of yen

8,170
10,433

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

Equity Ratio

Millions of yen

7,209
8,506

6.938 million yen
8,094 million yen

Net Assets per Share
%

84.9
77.6

Yen

164.32204.83

(3) Consolidated Cash Flows
Cash Flows fromOperating Activities

Cash Flows from
Investing Activities

Millions of yen

FY 2023
FY 2022

Millions of yen(1,94)
1,614

Cash and Cash
Equivalents at End of
PeriodCash Flows from
Financing Activities
Millions of yen

(376)
(47)

Millions of yen

680
627

6,517
6,282

2. Dividends
Annual Dividend per Share
1st Quarter

FY 2022
FY 2023
FY 2024 (Forecast)

2nd Quarter

Yen

3rd Quarter

Yen

Yen

0.00
0.00
0.00

－
－
－

Fiscal Year End

Full YearYen

Yen Millions of yen

0.00
0.00
0.00

－
－
－

Ratio of
Dividends to
Net Assets(Consolidated)%%

Payout Ratio
Total Dividends(Consolidated)

0.00
0.00
0.00

－
－

－
－
－

－
－

3. Earnings Forecasts for FY 2024 (January 1, 2024 to December 31, 2024)
Net Sales
Full Year

Millions of yen

3,641

Operating Profit% Millions of yen(34.9)(2,837)(Percentages indicate year-on-year changes.)
Profit attributable toEarnings per Shareowners of parent

Ordinary Profit% Millions of yen% Millions of yen

%

－

－

－

(2,867)(2,870)Notes:(1) Changes in significant subsidiaries during the period:(Transfer of specified subsidiary accompanying a change in the scope of consolidation)
New: SymBio Pharma USA, Inc.
Removed: None

Yen

(71.93)

Yes ・ No

(2) 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

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

FY 2023

42,278,081 shares

FY 2022

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

FY 2023

87,720 shares

FY 2022

85,268 shares

FY 2023

39,902,249 shares

FY 202239,046,821 shares(iii) Average number of shares during theperiod (cumulative)* Summaries of financial statements are not subject to audit through certified public accountants or auditing 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 judged 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 section
1-(4) “ Future outlook,” on Page 5 of the attachment.

Index of the attachment
1. Overview of Business Results, etc. ........................................................................................................................................................ 2(1) Overview of business results for the fiscal year under review ......................................................................................................... 2(2) Overview of financial position for the fiscal year under review....................................................................................................... 4(3) Overview of cash flows for the fiscal year under review ................................................................................................................. 5(4) Future outlook .................................................................................................................................................................................. 5(5) Pipeline ............................................................................................................................................................................................ 6
2. Basic Views on Selection of Accounting Standards ............................................................................................................................... 7
3. Consolidated Financial Statements and Primary Notes.......................................................................................................................... 8(1) Consolidated balance sheet ............................................................................................................................................................ 10(2) Consolidated statements of income and consolidated statements of comprehensive income ......................................................... 11
Consolidated statements of comprehensive income ....................................................................................................................... 11(3) Consolidated statements of changes in equity ................................................................................................................................ 12(4) Consolidated statements of cash flows ........................................................................................................................................... 14(5) Notes to consolidated financial statements ..................................................................................................................................... 15(Notes to going concern assumptions) ............................................................................................................................................. 15(Changes in accounting policies) ..................................................................................................................................................... 15(Segment information) ..................................................................................................................................................................... 15(Per share information) .................................................................................................................................................................... 15(Significant subsequent events) ....................................................................................................................................................... 17―1―

1. Overview of Business Results, etc.
(1) Overview of business results for the fiscal year under review
Progress in the Company’s business for 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, and the Company achieved its most important milestone for FY2021,
which was to attain profitability.
To achieve nationwide distribution, we have entered into distribution agreements with Suzuken Co., Ltd. and Toho PharmaceuticalCo., Ltd. We are also working with S.D. Collabo Co., Ltd. and have established two logistics centers, one in eastern and one inwestern Japan. Additionally, by deploying drug information personnel across the country, we have established a system that allows
us to provide more scientific information to healthcare providers..
In February 2022 (FY2022), the Group obtained approval of a partial change to our marketing authorization of the ready-to-dilute(RTD) liquid formulation of TREAKISYM® to add rapid infusion (RI) administration. The RTD formulation of TREAKISYM® is aliquid formulation that does not require manual reconstitution, significantly reducing preparation time. RI administration reduces theinfusion time from 60 minutes to 10 minutes, benefiting both patients and healthcare providers. In addition, the reduction in infusion
volume of RI from 250 ml to 50 ml means a lower volume of saline solution is used.
As of the end of December 2023, more than 90% of medical institutions had converted to RI administration.
Prescriptions for bendamustine in combination with rituximab ("BR therapy") and in combination with rituximab andpolatuzumab vedotin (genetical recombination) ("Pola-BR therapy") for rr/DLBCL continue to be lower due to the spread of novel
coronavirus variants and other infectious diseases and the concern of some physicians that patients with hematological malignancies,
especially malignant lymphoma patients, may be at risk of prolonged or more severe infection during or after bendamustine treatment.
Net sales were 5,589,708 thousand yen (down 44.1% year-on-year).
Selling, general and administrative expenses totaled 5,222,681 thousand yen (-7.3% year on year). This amount includes researchand development expenses of 2,638,234 thousand yen (+3.3% year on year).
Operating loss was 811,668 thousand yen (versus an operating profit of 1,963,625 thousand yen for the same period in FY 2022)
and ordinary loss was 736,130 thousand yen (versus an ordinary profit of 1,999,878 thousand yen for the same period in FY 2022).
Loss attributable to owners of parent was 1,962,817 thousand yen (versus profit attributable to owners of parent of 1,179,238
thousand yen for the same period in FY 2022), impacted by the reversal of deferred tax assets of 744,728 thousand yen in income
taxes-deferred and recognized an Impairment loss,etc. of 560,590 thousand yen as a result of examining "Accounting Standard for
Impairment of Fixed Assets".

In February 2022, generic bendamustine products from four companies were approved for

manufacturing and two of these products started to be sold 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 generic products, 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 andcompensation for damages arising from the infringement. The litigations are ongoing and the Company is diligently taking
appropriate steps to preserve its rights.
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 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®)
In February 2022, clinical trials on the safety of RI administration were completed and a partial change to our marketing
authorization was approved to permit the use of RI injection for all indications approved for the RTD formulation.
The Group continues to actively conduct further research on TREAKISYM®, such as ongoing joint research with the Universityof Tokyo and Kyoto University, to explore new potential uses and development of the drug.

―2―(b) Anticancer agents: SyB L-1101 (intravenous formulation) and SyB C-1101 (oral formulation) (generic name: rigosertib
sodium)Rigosertib is 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 TREAKISYM®).
(c) Antiviral drug: SyB V-1901 (intravenous formulation) (generic name: Brincidofovir [BCV])With a view to global expansion, the Group is developing brincidofovir (SyB V-1901, hereinafter "IV BCV" and "Oral BCV",
respectively), an antiviral drug in-licensed from Chimerix, Inc. with their broad activity against double-stranded DNA viruses(dsDNA viruses). The Group is conducting joint research with leading research facilities in Japan and overseas. Global clinical
trials will be considered and implemented based on the scientific findings of the research.
The Group is prioritizing the global development of BCV IV, focusing on Japan, the United States, and Europe, for the treatmentof adenovirus infection in immunocompromised patients, such as those who have had hematopoietic stem cell transplantation ororgan transplantation. In March 2021, we submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug
Administration (FDA) to initiate a Phase II clinical trial for the treatment of adenovirus infection and infectious diseases, primarily
in pediatric patients (including adults). in immunocompromised patients with adenovirus (AdV) infection
The Group is prioritizing global development of BCV (primarily in Japan, the U.S., and Europe), targeting disseminatedadenovirus (AdV) infections occurring after hematopoietic stem cell transplantation or organ transplantation. In March 2021, theGroup filed an Investigational New Drug (IND) application with the FDA to conduct a Phase II clinical trial in
immunocompromised patients (primarily pediatric but also adults) suffering from AdV infection. In April 2021, the program was
granted Fast Track designation by the FDA, and in May 2023, this study established human POC for BCV. Positive data
demonstrating the efficacy of the study was presented orally at the 65th Annual Meeting of the American Society of Hematology
in December 2023. Additionally, a patent for the use of BCV for the treatment of adenovirus infection and infectious diseases basedon these results was granted and registered in Japan in January 2024.
The Group submitted clinical trial notifications for a Phase II study of IV BCV in patients with BK virus (BKV) infection after
kidney transplantation to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan and the Therapeutic Goods
Administration (TGA) of Australia, in May and August 2022, respectively. BKV infection after kidney transplantation is a disease
with serious consequences for the recipient, the donor, the medical practitioner, and society, due to the risk of impaired renal
function and loss of the transplanted kidney (graft loss). The investigational drug was administered to the first subject in December
2022. Although the trial was planned to be completed in 2025, due to enrollment delays, we will discuss modifications to theprotocol will researchers.
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 U.S. National Institutes of Health (NIH), for thetransfer of materials to evaluate the antiviral effect of BCV in EBV. In March 2023, the Company entered into a Cooperative
Research and Development Agreement (CRADA) for BCV with NINDS for research to verify the efficacy of BCV as an anti-viraltherapeutic for EBV in the treatment of multiple sclerosis, and to obtain necessary data with a view to future clinical trials. In
October 2023 , the results of the research were presented by Dr. Maria Chiara Monaco at the 9th Joint ECTRIMS-ACTRIMS
Meeting in Milan, Italy. 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 associatedlymphoproliferative diseases.
Among dsDNA viruses, polyomaviruses are known to cause serious diseases through their infection. As existing antiviral drugs
show little efficacy, a high medical need exists for the development of an effective treatment. In November 2022, the Group enteredinto Material Transfer Agreement with Penn State College of Medicine whereby the Group will provide BCV for use in a nonclinical study to evaluate the efficacy of BCV in a mouse model of polyomavirus infection.
Some dsDNA viruses, such as herpes simplex virus type 1 (HSV1) and varicella zoster virus (VZV), are directed against cranial
nerve tissues. Recent research has advanced on 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 Agreementwith Tufts University to conduct research to evaluate the efficacy of BCV in a HSV infection model using a 3D (three-dimensional)―3―

brain model developed by Tufts University.
In addition to its strong antiviral effect, BCV also is expected to have an antitumor effect, and the Group is exploring BCV’spotential in indications such as EBV-positive lymphoma, refractory brain tumors, and other cancers, through research collaborations
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 the treatment of NK/Tcell lymphoma, for which no effective treatment is currently available, were presented by Dr. Jason Chan at the 64th American
Society of Hematology (ASH) Annual Meeting in New Orleans. Additionally, in June 2023, the results of its research collaboration
with NCCS on BCV were presented at the 17th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland.
In September 2022, Chimerix announced the close of the sale of its brincidofovir business to Emergent BioSolutions(headquartered in Maryland, USA). The sale does not affect our exclusive worldwide license of the rights for development,
manufacturing, and marketing of BCV in all indications except orthopox diseases.
(iii) Business outside Japan
In August 2023, the Group appointed Stephane Berthier, PharmD, as CEO and President of SymBio Pharma USA, Inc., and in
September 2023, appointed Nkechi Azie, MD, to the Group management team as Global Chief Medical Officer (CMO) to further
strengthen the Group’s global development structure and make SymBio Pharma USA, Inc. the driving force for our international
clinical trials as we move forward with global development of BCV.
(iv) Licensing of new drug candidates
The Group continues to evaluate promising new drug candidates for in-licensing. Through these efforts, the Groupaims to create medium-to long-term business value.

(2) Summary of financial position
Total consolidated assets as of September 31, 2023, stood at 8,170,243 thousand yen. Current assets totaled 8,082,526 thousand yen,mainly consisting of 6,517,007 thousand yen in cash and deposits, 913,094 thousand yen in accounts receivable-trade, and 231,650
thousand yen in merchandise and finished goods. All fixed assets were impaired at the end of the current period as a result of a review
of revenue projections. In addition, the security deposit and guarantee money for the new head office due to the relocation were also
impaired at 87,716 thousand yen as a result of restoration costs.
Total liabilities were 960,334 thousand yen. Current liabilities totaled 956,625 thousand yen, mainly consisting of 853,825 thousand
yen in accounts payable-other. Non-current liabilities were 3,709 thousand yen, consisting of 3,709 thousand yen in liabilities for
retirement benefits.
Total net assets stood at 7,209,909 thousand yen. This includes 17,952,692 thousand yen in capital stock, 17,927,584 thousand yen
in capital surplus, and 277,044 thousand yen in share acquisition rights.
As a result, the equity ratio was 84.9%.

(3) Overview of cash flows for the fiscal year under review
Cash and cash equivalents (hereinafter, “net cash”) stood at 6,517,007 thousand yen as of December 31, 2023
Cash flows during the fiscal year under review and their causes are as follows.
(Cash flows from operating activities)
Net cash provided by operating activities was 194,685 thousand yen. The key drivers were 1,195,387 thousand yen in loss before income
taxes and a decrease of 1,171, 821 thousand yen in receivable-trade. Cash outflows were mainly due to an decrease of 212,814 thousand
yen in consumption taxes receivable, an increase of 237,277 thousand yen in inventory.
(Cash flows from investing activities)
Net cash used in investing activities was 376,696 thousand yen, mainly attributable to purchase of fixed assets of 204,250
thousand yen and intangible assets of 28,547 thousand yen.
(Cash flows from financing activities)
Net cash provided by financing activities was 680,160 thousand yen, mainly attributable to proceed from issuance of shares of692,400 thousand yen. in proceeds from issuance of shares.

―4―

18th Term
FY 202219th Term
FY 2023

Equity ratio (%)

77.6

84.9

Equity ratio on a fair market value basis (%)

243.6

127.55

Debt redemption period (years)――

Interest coverage ratio――

Equity ratio: Equity (total shareholders’ equity)/total assets
Equity ratio on a fair market value basis: Total market value of common stock/total assets
Debt redemption period: Interest-bearing debt/cash flows from operating activities
Interest coverage ratio: Cash flows from operating activities/interest payments(Notes) 1. As the Group began preparing consolidated financial statements in FY2022, figures for FY2021 and earlier are notpresented.
2. Total market value is calculated based on the number of shares issued, excluding treasury shares.
3. Debt redemption period and interest coverage ratio are not available due to the absence of interest payments in FY
2022.

(4) Future outlook
The Group expects net sales for FY 2024 to decrease to 3,641 million yen, a decrease of 34.9% compared to FY 2023. While theGroup aims to further expand the market share of TREAKISYM®, net sales have been impacted due to the significant reduction in
NHI drug price as a result of TREAKISYM® being excluded from the new drug creation premium and the impact of genericproducts on TREAKISYM® sales. In addition, the Group initiated litigation against two manufacturers of generic versions of
TREAKISYM® based on patent infringement. As the litigations are ongoing, the potential impact of the lawsuits on net sales is notreflected.
Regarding research and development, we will continue the global development of IV BCV for treatment of AdV infection andcontinue to explore development for other indications through joint research with academia with the aim of enhancing long-term
corporate value. The Group expects R&D expenses to increase to 3,207 million yen in FY 2024 (compared to 2,638 million yen in
FY 2023).
As a result, for the fiscal year ending December 31, 2024, the Group forecasts net sales of 3,641 million yen, operating loss of
2,837 million yen, ordinary loss of 2,867 million yen, and loss attributable to owners of parent of 2,870 million yen.

―5―(5) Pipeline
The Group currently has the following pipeline products under development: SyB L-0501, SyB L-1101, SyB C-1101, SyB L1701, SyB L-1702, and SyB V-1901. The Group will continue to in-license candidate drugs to further expand and build its pipeline
portfolio with a balanced risk–return trade-off.
(i) [Anticancer agents: SyB L-0501 (FD formulation), SyB L-1701 (RTD formulation), SyB L-1702 (RI injection), (generic name:bendamustine hydrochloride or bendamustine hydrochloride hydrate, trade name: TREAKISYM®)]
Bendamustine hydrochloride (the generic name), the active pharmaceutical ingredient of TREAKISYM®, is an anticancer
agent that has been in use for a number of years in Germany under the trade name of Ribomustin® for the treatment of nonHodgkin’s lymphoma, multiple myeloma, and chronic lymphocytic leukemia. The Group decided to in-license this productbecause there is currently no effective medication for the indications of recurrent/refractory low-grade non-Hodgkin’s lymphoma
and mantle cell lymphoma. These are underserved therapeutic areas aligned with the Group’s corporate mission and also fallwithin one of the Group’s targeted therapeutic fields (hematologic cancer). Astellas Deutschland GmbH, a German subsidiary of
Astellas Pharma Inc., is the worldwide licensor of bendamustine hydrochloride.
The Group licensed from Astellas Deutschland GmbH with exclusive rights for the development and commercialization of
bendamustine hydrochloride in Japan, China, South Korea, Singapore, and Taiwan. In Japan, the drug was approved for theindications of recurrent/refractory low-grade non-Hodgkin’s lymphoma and mantle cell lymphoma in October 2010, and waslaunched under the trade name TREAKISYM® in December 2010. In December 2015, the Group filed a partial change
application to include the additional target indications of first-line treatment of low-grade non-Hodgkin’s lymphoma and mantle
cell lymphoma, and chronic lymphocytic leukemia. The Group obtained approval for the indication of chronic lymphocytic
leukemia in August 2016 and of first-line treatment of low-grade non-Hodgkin’s lymphoma and mantle cell lymphoma in
December 2016. In May 2020, the Group submitted a partial change application to include the indication of recurrent/refractory
diffuse large B-cell lymphoma (r/r DLBCL), and obtained approval in March 2021. In order to maximize the business value of
TREAKISYM® by further promoting product life cycle management, the Group concluded an exclusive license agreement with
Eagle Pharmaceuticals in September 2017 to develop, market, and sell Eagle’s ready-to-dilute (“RTD”) liquid formulation
injection and rapid infusion (“RI”) administration products in Japan. The Group obtained approval for the RTD formulation in
September 2020, and launched the product in January 2021. For the RI injection, the Group filed a partial change application in
May 2021. In February 2022, we obtained approval of a partial change to our marketing authorization enable the use of RI
administration for all indications for which RTD is approved. We will continue joint research with academia, including ongoing
research with the University of Tokyo and Kyoto University, to explore new potential uses and development possibilities for
Treakisym®.
(ii) [Anticancer agents: SyB L-1101 (intravenous formulation) and SyB C-1101 (oral formulation) (generic name: rigosertib
sodium)]Rigosertib is an anticancer agent with a unique type of multikinase inhibitory activity. It is currently being developed in the
U.S., Europe, and elsewhere by a U.S. company, Onconova Therapeutics, Inc. (“Onconova”), for the target indications of
myelodysplastic syndromes (“MDS”). MDS is the pre-pathological state for malignant tumors of blood cells, which has shown
increasing numbers of patients in recent years; it frequently affects elderly people; and it is a refractory disease, with a highprobability of developing into leukemia.
No effective medication is available yet, especially for recurrent/refractory MDS, and it therefore constitutes an underserved
therapeutic area. In July 2011, the Group signed a license agreement with Onconova, obtaining the exclusive right to develop andcommercialize rigosertib in Japan and South Korea. Based on this agreement, the Group had developed the intravenous rigosertib
formulation for the target indication of recurrent/refractory higher-risk MDS and the oral formulation for the target indication of
first-line higher-risk MDS (in combination with azacitidine).
Through joint research with the University of Tokyo, we are exploring new indications for rigosertib in combination with otherdrugs, including TREAKISYM®.
(iii) [Antiviral drug: SyB V-1901 (generic name: brincidofovir [BCV])]In September 2019, the Group concluded an exclusive global licensing agreement for antiviral drug brincidofovir (“BCV”)
with Chimerix Inc. Under this agreement, the Group acquired the exclusive rights for the worldwide development, marketing,and manufacture of BCV for all human indications, excluding orthopox viruses.
The Group is prioritizing the global development of BCV, targeting adenovirus (AdV) infections in immunocompromised―6―

patients, including patients who have had hematopoietic stem cell transplantation—a niche area with a high unmet medical need,
and a Phase II clinical trial of BCV IV is currently being conducted.
Based on the knowledge and insight on the safety and efficacy of BCV obtained from the clinical trial of IV BCV for treatmentof AdV infections, the Group will investigate the effectiveness of BCV in treating various other dsDNA virus infections
following hematopoietic stem cell transplantation and aim to expand target indications to include multiviral infections. BK virus(BKV) infection after kidney transplantation is a disease with serious consequences due to the risk of impaired renal function andloss of the transplanted kidney (graft loss). The Group has commenced a Phase II clinical trial in patients infected with BKV after
kidney transplantation and the investigational drug was administered to the first patient in Australia In December 2022. In clinicalstudies conducted by Chimerix in Europe and the U.S., Oral BCV has been shown to have broad antiviral activity against dsDNA
viruses. Oral BCV’s antiviral activity against dsDNA viruses suggests that IV BCV may also be safe and effective in theprevention and treatment of various viral infections following hematopoietic stem cell transplantation.
In December 2020, Chimerix announced that the FDA had accepted its NDA for Oral BCV for the treatment of smallpox, andthe NDA was approved by the FDA in June 2021.

2. Basic Views on Selection of Accounting Standards
Over the near term, the Group will prepare its financial statements based on Japanese generally accepted accounting principles(GAAP), taking into account the inter-period comparability of financial statements and comparability across companies.
In terms of the application of International Financial Reporting Standards (IFRS), the Group will take appropriate measures inlight of the existing circumstances in Japan and overseas.

―7―

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

FY 2023(as of December 31, 2023)

AssetsCurrent assets
Cash and deposits

6,282,554
2,084,915

6,517,007
913,094

293,757
175,170

231,650-452
252,745380
271,516

209,886
13,224

119,271
29,6079,312,706

8,082,526

40,67028,339-69,009-Software
Software in progress

222,204---

Total intangible assets

222,204-

744,728
84,69887,716

829,427
1,120,641

87,716

10,433,347

8,170,243

46,633
1,163,721

853,825

401,066

16,784
18,474

16,331
296,118

67,5401,923,870

956,625

3,385

3,709

3,385
1,927,255

3,709

Accounts receivable–trade
Merchandise and finished goods
Semi-finished goods
Stored goods
Advance payments
Prepaid expenses
Other
Total current assets
Non-current assets
Property, plant and equipment
Buildings, net
Tools, furniture and fixtures, net
Construction in progress
Total property, plant and equipment
Intangible assets

Investments and other assets
Deferred tax assets
Leasehold and guarantee deposits
Total investments and other assets
Total non-current assets
Total assets

87,716

Liabilities
Current liabilities
Accounts payable–trade
Accounts payable–other
Provision for office transfer expenses
Income taxes payable
Provision for product changeover
Other
Total current liabilities
Non-current liabilities
Liabilities for retirement benefits
Total non-current liabilities
Total liabilities―8―960,334

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

FY 2023(as of December 31, 2023)

Net assets
Shareholders’ equity
Share capital

17,548,459
17,523,357

17,952,692
17,927,584(26,889,486)(88,154)(28,852,303)(89,122)8,094,176

6,938,849

Foreign currency translation adjustment

243(5,985)

Total accumulated other comprehensive income

243(5,985)

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

Share acquisition rights
Total net assets
Total liabilities and net assets―9―411,672

277,0448,506,092

7,209.909

10,433,347

8,170,243

(2) Consolidated statements of income and consolidated statements of comprehensive income
Consolidated statements of income

Net sales
Cost of sales

10,008,338
2,408,434(Unit: thousands of yen)
FY 2023(from January 1, 2023
to December 31, 2023)
5,589,708
1,178,694

Gross profit

7,599,904

4,411,013

Selling, general and administrative expenses

5,636,278

5,222,681

Operating profit (loss)

1,963,625(811,668)

98

11,972

Other136,179
2,925

117,106
3,711

Total non-operating income

139,204

132,789

56,543

12,72845,867-

11,47825,176

FY 2022(from January 1, 2022
to December 31, 2022)

Non-operating income
Interest income
Foreign exchange gains

Non-operating expenses
Commission expenses
Share issuance costs
Provision for office relocation expenses
Loss on retirement of fixed assets
Total non-operating expenses
Ordinary profit
Extraordinary income
Gain on reversal of share acquisition rights
Total extraordinary income

540

7,868

102,951

57,252

1,999,878(736,130)

106,401

101,333

106,401

101,333

Extraordinary loss
Impairment loss

560,590

Total extraordinary loss

560,590
2,106,279(1,195,387)

Income taxes - deferred

396,010531,030

22,700744,728

Total income taxes

927,041

767,429

1,179,238(1,962,817)--

1,179,238(1,962,817)

Profit before income taxes
Income taxes - current

Profit (loss)
Profit attributable to non-controlling interests
Profit (loss) attributable to owners of parent―10―

Consolidated statements of comprehensive income

ProfitAccumulated other comprehensive income

1,179,238(Unit: thousands of yen)
FY 2023(from January 1, 2023
to December 31, 2023)(1,962,817)

Foreign currency translation adjustment

198

6,228

Total other comprehensive income

198

6,228

1,179,437(1,956,588)

1,179,437(1,956,588)––

FY 2022(from January 1, 2022
to December 31, 2022)

Comprehensive income
Comprehensive income attributable toComprehensive income attributable to owners of parent
Comprehensive income attributable to non-controllinginterests―11―

(3) Consolidated statements of changes in equity
FY 2022 (from January 1, 2022 to December 31, 2022)(Unit: thousands of yen)
Shareholder’s equity

Balance at beginning of period
Cumulative effect of changes
in accounting policies
Restated balance
Changes during period
Issuance of new shares
Issuance of new shares(exercise of share acquisitionrights)Profit attributable to ownersof parent
Purchase of treasury shares
Disposal of treasury shares
Net changes of items otherthan shareholders’ equity
Total changes during period
Balance at end of period

Share capital

Capital surplus

Retainedearnings

17,157,628

17,132,501(27,975,902)

Cumulative effect of changes
in accounting policies
Restated balance
Changes during period
Issuance of new shares
Issuance of new shares(exercise of share acquisitionrights)Profit attributable to ownersof parent
Purchase of treasury shares
Disposal of treasury shares(86,045)(92,822)(28,068,725)

Total
Shareholder’sequity6,228,181(92,822)

17,157,628

17,132,501

331,000

331,000

662,000

59,831

59,831

119,662(86,045)

1,179,238
24

6,135,358

1,179,238(2,165)56(2,165)
81

390,831

390,856

1,179,238(2,108)

1,958,817

17,548,459

17,523,357(26,889,486)(88,154)

8,094,176

Accumulated other comprehensive
incomeTotal
Foreignaccumulated
currency
othertranslation
comprehensive
adjustment
incomeBalance at beginning of period

Treasury shares

44

44

Share
acquisitionrightsTotal net assets

519,099

6,747,325(92,822)44

44519,099

6,654,502
662,000
119,662
1,179,238(2,165)81

Net changes of items otherthan shareholders’ equity

198

198

(107,426)(107,228)

Total changes during period

198

198

(107,426)

1,851,589

Balance at end of period

243

243

411,672

8,506,092―12―

FY 2023 (from January 1, 2023 to December 31, 2023)(Unit: thousands of yen)
Shareholder’s equity

Balance at beginning of period

Total
Shareholder’sequity8,094,176

Share capital

Capital surplus

Retainedearnings

17,548,459

17,523,357(26,889,486)

346,200

346,200

692,400

58,03258,032116,065

Treasury shares(88,154)

Restated balance
Changes during period
Issuance of new shares
Issuance of new shares(exercise of share acquisitionrights)Profit attributable to ownersof parent
Purchase of treasury shares
Disposal of treasury shares
Net changes of items otherthan shareholders’ equity
Total changes during period
Balance at end of period(1,962,817)

(6)

(996)

(996)

28

21

404,232

404,226(1,962,817)(968)(1,155,326)

17,952,692

17,927,584(28,852,303)(89,122)

6,938,849

Accumulated other comprehensive
incomeTotal
Foreignaccumulated
currency
othertranslation
comprehensive
adjustment
incomeBalance at beginning of period(1,962,817)

243

243

Share
acquisitionrightsTotal net assets

411,672

8,506,092

Restated balance
Changes during period
Issuance of new shares
Issuance of new shares(exercise of share acquisitionrights)Profit attributable to ownersof parent
Purchase of treasury shares
Disposal of treasury shares

692,400
116,065(1,962,817)
(996)
4,919
21

Net changes of items otherthan shareholders’ equity(6,228)(6,228)(134,627)(140,856)

Total changes during period(6,228)(6,228)(134,627)(1,296,183)

Balance at end of period(5,985)(5,985)

277,044

7,209,909―13―

(4) Consolidated statements of cash flows(Unit: yen in thousands)
FY 2022(from January 1, 2022
to December 31, 2022)
Cash flows from operating activities
Profit before income taxes

FY 2023(from January 1, 2023
to December 31, 2023)

2,106,279(1,195,387)

Depreciation
Amortization of guarantee deposits

98,092
1,339

96,0052,381

Impairment loss
Share-based remuneration expenses

104,731560,590
82,497

Increase (decrease) in provision for retirement benefits
Increase (decrease) in provision for product changeover

609(171,081)

324(16,331)(98)

16,784(11,972)

Foreign exchange losses (gains)
Commission expenses(370,416)
56,543(132,415)
12,728

Share issuance cost
Gain on reversal of share acquisition rights

45,867(106,401)

11,478(101,333)

Loss on retirement of non-current assets
Decrease (increase) in trade receivables

540
62,594

7,868
1,171,821

Decrease (increase) in inventories
Decrease (increase) in prepaid expenses
Increase/decrease in consumption taxes
payable/consumption taxes refund receivable
Decrease (increase) in other current assets(82,746)(64,874)

237,277
90,614(270,711)(212,814)(89,984)(23,384)

Increase (decrease) in notes and accounts payable–trade
Increase (decrease) in accounts payable–other(23,050)
685,306(46,633)(310,273)

Increase (decrease) in other current liabilities
Others(105,844)
157,769(66,344)(1,700)Subtotal

2,034,463(171,781)

98(56,543)274(12,029)

Increase (decrease) in provision for office transfer expenses
Interest income

Interest and dividends received
Commitment fee paid
Income taxes paid

(363,776)(354,711)

Net cash provided by (used in) operating activities

1,614,241(194,685)(2,034)(45,524)(204,250)(28,547)432(143,898)-(47,127)(376,696)

146

274

Cash flows from investing activities
Purchase of property, plant and equipment
Purchase of intangible assets
Leasehold and guarantee deposits
Proceeds from refund of leasehold and guarantee deposits
Net cash provided by (used in) investing activities
Cash flows from financing activities
Proceeds from issuance of shares resulting from exercise ofshare acquisition rights
Proceeds from issuance of share acquisition rights

13,760-

Payments for issuance of shares
Proceeds from issuance of shares(45,837)
662,000(11,538)
692,400

Purchase of treasury shares
Proceeds from disposal of treasury shares(2,165)
81

(996)
21

Net cash provided by (used in) financing activities

627,985

680,160

Effect of exchange rate change on cash and cash equivalents

213,710

125,673

Net increase (decrease) in cash and cash equivalents

2,408,809

234,452

Cash and cash equivalents at beginning of period
Increase in cash and cash equivalents resulting from inclusion ofsubsidiaries in consolidation
Cash and cash equivalents at end of period

3,860,106

6,282,554-―14―

13,637
6,282,554

6,517,007

(5) Notes to consolidated financial statements(Notes to going concern assumptions)None to be reported.
(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 quarter 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.
(Segment information)

Segment information is omitted since the Group operates within a single segment, which includes the research anddevelopment, manufacturing, and marketing of pharmaceutical drugs and other related activities.
(Per share information)
FY 2022(from January 1, 2022
to December 31, 2022)

FY 2023(from January 1, 2023
to December 31, 2023)

Net assets per share

204.83 yen

164.32 yen

Net income per share

30.20 yen

(49.19 yen)

Dilutive net income per share

29.77 yen―

(Notes) The basis of the calculation of basic earnings per share and diluted earnings per share is as follows.
FY 2022(from January 1, 2022
to December 31, 2022)

FY 2023(from January 1, 2023
to December 31, 2023)

Basic earnings per share
Profit attributable to owners of parent (thousands of yen)

1,179,238(1,962,817)――

Profit attributable to owners of parent of common stock(thousands of yen)

1,179,238(1,962,817)

Average number of common stock during the fiscal year (shares)

39,046,822

39,902,249――

Amount not attributable to common shareholders
yen)(thousands of

Diluted earnings per share
Adjustment of profit attributable to owners of parent (thousandsof yen)Increase in shares of common stock (shares)

558,585

344,572(Of which, share acquisition rights) (shares)(558,585)(344,572)

Outline of dilutive shares not included in the calculation of diluted
earnings per share because they have no dilutive effect―15―

1 types of share acquisitionrights (20,000 units) inaccordance with theCompanies Act Article 236,
238, and 239.

1 types of share acquisitionrights (20,000 units) inaccordance with theCompanies Act Article 236,
238, and 239.

Basic calculation of net assets per share
FY 2022(from January 1, 2022
to December 31, 2022)
Total net assets (thousand of yen)

FY 2023(from January 1, 2023
to December 31, 2023)

8,506,092

7,209,909

Amount deducted from total net assets (thousand of yen)

411,672

277,044(Of which stock acquisition rights) (thousand of yen)

(411,672)(277,044)(Of which, noncontrolling interests) (thousand of yen)

(-)

(-)

Net assets related to common stock at the end of the period(thousand of yen)

8,094,419

6,932,864

Number of shares of common stock used in the calculation of net
assets per share at the end of the period (shares)

39,518,338

42,190,361―16―

(Significant subsequent events)(Execution of agreement establishing share issuance program and issuance of new shares by way of third-party allotment)
On October 6, 2023 (the “Initial Press Release”), the Company announced that the Company’s Board of Directors, at a meeting
held on the same date, had resolved to enter into an agreement with EVO FUND (the “Allottee”) to set up an equity issue program(the “Agreement to Set up an Equity Issue Program”), and based on the equity issue program established under the Agreement to Set
up an Equity Issue Program (the “Program”), to issue new shares in five tranches (shares issued to the Allottee, whether individuallyor collectively, under the Program are referred to as the “Shares”).
The Company is authorized to issue up to a total of 6,000,000 ordinary shares by way of third-party allotment to the allottees in
the period from 25 October 2023 to 3 April 2024, with ordinary shares to be issued by way of a total of five allotments, from the firstto the fifth allotment.
As at the date of submission, the new shares to be issued by way of third-party allotment are as follows.
(3rd allotment)
The payment was completed on February 7, 2024.
1Class and Numbers Shares Offered

1,200,000 common shares

2

Issue Price

230 yen per share

3

Capital inclusion amount

115 yen per share

4

Total Issue Price

276,000,000 Yen

5

Increases in Capital Stock and Legal Capital Surplus

138,000,000 Yen

6

Allotment resolution date

January 22, 2024

7

Deadline for Application

February 7, 2024

8

Due Date of Payment

February 7, 2024

9

Allottee

EVO FUND(1) Development

funds

for

antiviraldrugbrincidofovir (direct expenses)(2) Development funds for antiviral drug
10

Specific uses

brincidofovir (indirect expenses)(3) Investment in new in-licensing and M&A forthe purpose of securing long-term growth
opportunities.

―17―

(4th allotment) *Note 1
1Class and Numbers Shares Offered

1,200,000 common shares

2

Issue Price

To be determined *Note 2
The amount to be contributed to capital stock shall behalf the upper limit of an increase in capital stock
under Article 14, Paragraph 1, of the Rules of3

Corporate Accounting (with any fractional amounts

Capital inclusion amountless than one yen resulting from such calculation
rounded up). The increase in the legal surplus shallbe the upper limit of an increase in capital stock lessthe amount of the increase in capital stock.

4

Total Issue Price

To be determined.

5

Increases in Capital Stock and Legal Capital Surplus

To be determined.

6

Allotment resolution dateFebruary 29, 2024 *Note 3

7

Deadline for Application

March 18, 2024

8

Due Date of Payment

March 18, 2024 *Note 3

9Allottee

EVO FUND(1) Development

funds

for

antiviraldrugbrincidofovir (direct expenses(2) Development funds for antiviral drug
10

Specific uses

brincidofovir (indirect expenses)(3) Investment in new in-licensing and M&A forthe purpose of securing long-term growth
opportunities.

(5th allotment) *Note 1
1Class and Numbers Shares Offered

1,200,000 common shares

2

Issue Price

To be determined
The amount to be contributed to capital stock shall behalf the upper limit of an increase in capital stock
under Article 14, Paragraph 1, of the Rules of3

Corporate Accounting (with any fractional amounts

Capital inclusion amountless than one yen resulting from such calculation
rounded up). The increase in the legal surplus shall be
the upper limit of an increase in capital stock less theamount of the increase in capital stock.

4

Total Issue Price

To be determined.

5

Increases in Capital Stock and Legal Capital Surplus

To be determined.

6

Allotment resolution date

April 3, 2023 *Note 3

7

Deadline for Application

April 19, 2024

8

Due Date of Payment

April 19, 2024 *Note 3

9Allottee

EVO FUND―18―

(1) Development

funds

for

antiviraldrugbrincidofovir (direct expenses(2) Development funds for antiviral drug
10

Specific uses

brincidofovir (indirect expenses)(3) Investment in new in-licensing and M&A forthe purpose of securing long-term growth
opportunities.

*Note 1. The number of shares for each of the 4th through 5th allotments will range from 1,200,000 shares to 2,500,000 shares, and thetotal will not exceed the 6,000,000 shares stipulated for issuance under the Program. The actual number will be determined by the
Allottee notifying the Company prior to the date of the resolution by the Board of Directors for each allotment (the “Allotment Resolution
Date”).
*Note 2. The issue price for each allotment will be the amount equal to the simple average of the closing price of common shares of theCompany announced by the Tokyo Stock Exchange, Inc. (the “TSE”) during the 10 trading days up to and including the day immediately
preceding the Allotment Resolution Date (rounded off to the first decimal place). (However, if there is no closing price for any of the 10
trading days, the Allotee may decide whether to include such a day in the calculation of the issue price.)*Note 3. The Allotment Resolution Date and the due date of payment may be changed, if agreed upon by the Company and the Allottee.
If such changes occur, the Company will withdraw the securities registration statement allotment and submit a new securities registration
statement.

―19―