Summary of Financial Statements for the Fiscal Year Ended December 31, 2022
[Japanese GAAP] (Consolidated)
February 9, 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

Corporate Officer andChief Financial Officer

Takaaki Fukushima

TEL +81-3-5472-1125

Ordinary Annual General
Meeting of Shareholders

March 23, 2023

Date of Dividend
Payment (plan)—

Scheduled Date to File
Securities Report

March 23, 2023

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 2022 (January 1, 2022 to December 31, 2022)(1) Consolidated Operating Results
Net Sales
FY 2022
FY 2021(Percentages indicate year-on-year changes.)

Operating Profit

Profit attributable toowners of parent

Ordinary Profit

Millions of yen%

Millions of yen%

Millions of yen%

Millions of yen%

10,008
－

－
－

1,963
－

－
－

1,999
－

－
－

1,179
－

－
－

(Note) Comprehensive income:

FY 2022
FY 2021
Diluted Earnings per
Share

Earnings per ShareFY 2022
FY 2021

1,179 million yen ( -%)－ million yen ( -%)Ratio of Ordinary
Profit to Total Assets(ROA)

Ratio of Profit to
Equity (ROE)

Ratio of Operating
Profit to Net Sales

Yen

Yen

%

%

%

30.20
－

29.77
－

14.6
－

19.2
－

19.6
－

(Reference) Equity in net income of affiliated companies:

FY 2022－ million yen
FY 2021－ million yen(Note) The Group began preparing consolidated financial statements from FY 2022 with the start of operations at SymBio Pharma
USA. As a result, figures for FY 2021 as well as year-on-year comparisons against FY 2021 have not been provided. 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 2022 (as of December 31, 2022)
FY 2021 (as of December 31, 2021)(Reference) Shareholders’ equity:

Net Assets

Equity Ratio

Net Assets per Share

Millions of yen

Millions of yen%

Yen

10,433
－

8,506
－

77.6
－

204.83－

FY 2022 (as of December 31, 2022)
8,094 million yen
FY 2021 (as of December 31, 2021)－ million yen(Note) The Group began preparing consolidated financial statements from FY 2022, and hence figures for FY 2021 have not been
provided.

(3) Consolidated Cash Flows
Cash Flows fromOperating Activities

Cash Flows from
Investing Activities

Millions of yen

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

Millions of yen

Millions of yen

Millions of yen

FY 2022
1,614
(47)
627
6,282
FY 2021－－－－(Note) The Group began preparing consolidated financial statements from FY 2022, and hence figures for FY 2021 have not been
provided.
2. Dividends

Yen

Yen

Yen

Yen

Yen Millions of yen

Ratio of
Dividends to
Net Assets(Consolidated)
%
%

－
－
－

0.00
0.00
0.00

－
－
－

0.00
0.00
0.00

0.00
0.00
0.00

－
－
－

Annual Dividend per Share
1st Quarter

FY 2021
FY 2022
FY 2023 (Forecast)

2nd Quarter

3rd Quarter

Fiscal Year End

Payout Ratio
Total Dividends(Consolidated)

Full Year

－
－

－
－

3. Earnings Forecasts for FY 2023 (January 1, 2023 to December 31, 2023)(Percentages indicate year-on-year changes.)
Net Sales
Millions of yen

Full Year

7,000

Operating Profit% Millions of yen(30.1)% Millions of yen(331)

Profit attributable toowners of parent

Ordinary Profit
－

(351)

Earnings per Share% Millions of yen

%

Yen

(370)

－

(9.48)－

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

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)(ii) Total number of treasury shares at the endof the period(iii) Average number of shares during theperiod (cumulative)

FY 2022

39,603,606 shares

FY 202138,457,206 shares

FY 2022

85,268 shares

FY 202182,618 shares

FY 202239,046,821 shares

FY 202138,313,220 shares

(Reference) Non-consolidated Financial Statements for Fiscal 2022
1. Business Results for FY 2022 (January 1, 2022 to December 31, 2022)(1) Non-consolidated Operating Results
Net Sales
FY 2022
FY 2021(Percentages indicate year-on-year changes.)

Operating Profit

Profit attributable toowners of parent

Ordinary Profit

Millions of yen%

Millions of yen%

Millions of yen%

Millions of yen%

10,008
8,256

21.2
176.4

1,972
1,016

94.1
－

2,001
1,001

99.9
－

1,186
2,032

(41.6)－

Earnings per ShareFY 2022
FY 2021

Diluted Earnings per Share
Yen

Yen

30.37
53.04

29.95
52.32

(2) Non-consolidated Financial Position
Total Assets
FY 2022 (as of December 31, 2022)
FY 2021 (as of December 31, 2021)(Reference) Shareholders’ equity:

Net Assets

Equity Ratio

Net Assets per Share

Millions of yen

Millions of yen%

Yen

10,410
8,452

8,511
6,745

77.8
73.7

204.95162.26

FY 2022 (as of December 31, 2022)
FY 2021 (as of December 31, 2021)

8,099 million yen
6,226 million yen* 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 “1.
Overview of Business Results, etc. (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 ............................................................................................................................... 8
3. Consolidated Financial Statements and Primary Notes.......................................................................................................................... 9(1) Consolidated balance sheet .............................................................................................................................................................. 9(2) Consolidated statements of income and consolidated statements of comprehensive income ......................................................... 11(3) Consolidated statements of changes in equity ................................................................................................................................ 13(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) .................................................................................................................................................................... 16(Significant subsequent events) ....................................................................................................................................................... 16―1―

1. Overview of Business Results, etc.
(1) Overview of business results for the fiscal year under review(Business results for the fiscal year under review)
From the fiscal year ended December 31, 2022, the Group began preparing consolidated financial statements in connection with thecommencement of full-fledged operations at its wholly-owned U.S.-based subsidiary, SymBio Pharma USA, Inc. (President: Carolyn
Yanavich), which serves as a strategic base for our global operations as a specialty pharmaceutical company. As reference, we haveprovided year-on-year comparisons with the non-consolidated financial statements in the same period last year, since there have beenno substantial changes in our business composition.
(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. This was a critical step of the Group to attain profitability in FY 2021,
which was a top priority for the fiscal year.
The Group has assigned medical representatives nationwide to establish a highly productive salesforce that can identify local
needs and plan detailed proposals. We also deployed hematology experts in each region of operation to provide information in amore scientific manner. To achieve nationwide distribution, we have entered into distribution agreements with Suzuken Co., Ltd.
and Toho Pharmaceutical Co., Ltd. with both companies as exclusive distributors. We are also working with S.D. Collabo Co., Ltd.
and have established two logistics centers, one in Eastern Japan and the other 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. Compared to the freeze-dried (FD) formulation, theRTD formulation of TREAKISYM® reduces the time required for the complicated dissolution process. RI administration further
reduces the infusion time to 10 minutes, relieving the burden on both patients and healthcare providers. The reduction in infusion
volume lowers the volume of saline solution and accordingly the amount of 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 December 2022.
As a result, net sales totaled 10,008,338 thousand yen (+21.2% year on year). Despite sales activities being constrained by delays
in treatment and continued restrictions on facility visits due to the spread of COVID-19, net sales rose due to the approval for theuse of TREAKISYM® in the bendamustine-rituximab (BR) therapy and in polatuzumab vedotin plus bendamustine-rituximab(Pola+BR) therapy to treat recurrent/refractory diffuse large B-cell lymphoma (r/r DLBCL).
Selling, general and administrative expenses totaled 5,636,278 thousand yen (+1.1% year on year). This amount includes researchand development expenses of 2,554,799 thousand yen (+47.2% year on year).
As a result, operating profit was 1,963,625 thousand yen (versus 1,016,001 thousand yen in the same period of FY 2021) andordinary profit was 1,999,878 thousand yen (versus 1,001,133 thousand yen in the same period of FY 2021). Profit attributable toowners of parent amounted to 1,179,238 thousand yen (versus 2,032,203 thousand yen in the same period of FY 2021, due in part to
the recording of 1,275,759 thousand yen in deferred tax assets). As cumulative total sales of the RTD formulation of TREAKISYM®
reached 11,000,000 thousand yen in FY 2022, the Group booked 550,000 thousand yen in sales milestone payments to Eagle
Pharmaceuticals, Inc. (head office: New Jersey, U.S.; hereinafter “Eagle”) under cost of sales.
In February 2022, generic versions of TREAKISYM® were approved for manufacturing and marketing in Japan. Given thepotential infringement of Eagle’s patents related to TREAKISYM® in Japan which are exclusively licensed to the Company, theCompany in coordination with Eagle notified four generic makers of potential patent infringement and requested they takeappropriate measures to avoid such infringement. In December 2022, Eagle and the Company commenced the litigation seeking an
injunction against the manufacture and sale of Pfizer’s and Towa’s generic version of TREAKISYM® and compensation for damages
arising from the infringement.
Segment information has been omitted since 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 fiscal year under review, we conducted the following research and development activities in each of our development―2―pipelines.
(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, the Group completed clinical studies on safety and 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 will actively conduct further research on TREAKISYM®, such as ongoing clinical research with Saitama Medical
University and joint research with Kyoto University, to explore new possibilities of the drug.
(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.; hereinafter “Onconova”) andTREAKISYM®, the Group is searching for new indications as well as new applications for the drugs used in combination witheach other or with other existing drugs, through joint research and the offering of academia-industry collaborative courses with the
University of Tokyo.
(c) Antiviral drug: SyB V-1901 (generic name: brincidofovir [BCV])In the development of the intravenous and oral formulations of antiviral drug brincidofovir (SyB V-1901; hereinafter “BCV IV”
and “BCV Oral”) , in-licensed from Chimerix Inc. (head office: North Carolina, U.S.; hereinafter “Chimerix”) with a view to global
rollout, the Group has been carrying out joint research with top research institutions of each specialized field in Japan and overseas
in light of the drugs’ broad effectiveness against dsDNA viruses.
The Group has decided to prioritize the global development of BCV IV primarily in Japan, the U.S., and Europe, targeting
disseminated AdV infections occurring after hematopoietic stem cell transplantation, a niche area with a high unmet medical need.
In March 2021, the Group filed an Investigational New Drug (IND) application with the FDA to conduct a Phase II clinical trial
primarily in pediatric patients suffering from AdV infections (also including adults). This development program was granted Fast
Track designation by the FDA in April 2021, and the investigational drug was administered to the first patient in August 2021. Asof December 31, 2022, 20 patients were enrolled.
BK virus (BKV) infection after kidney transplantation is a disease with serious consequences for the recipient, the donor, themedical practitioner, and the society, due to the risk of impaired renal function and loss of the transplanted kidney (graft loss). The
Group submitted a clinical trial notification for a global Phase II study in patients infected with BKV after kidney transplantation
to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan in May 2022 and filed another notification with theTherapeutic Goods Administration (TGA) of Australia in August 2022, and the investigational drug was administered to the first
patient in December 2022.
The Group is also looking to develop BCV to treat multiple sclerosis, an intractable disease that has recently been proven to be
associated with Epstein-Barr virus (EBV). In August 2022, the Group 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., for the transfer
of materials for evaluation of BCV’s potential antiviral effect on EBV.
Among double-stranded DNA viruses (dsDNA), polyomaviruses are known to cause serious diseases through their infection. As
existing antiviral drugs show little efficacy, the development of an effective treatment is eagerly awaited. 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.
Some double-stranded DNA viruses, such as HSV1 and VZV, are directed against cranial nerve tissues and are known to cause
serious diseases, including Alzheimer's disease, in various cranial nerve areas due to infection caused by their reactivation. In
December 2022, the Group entered into a Sponsored Research Agreement with Tufts University to conduct joint research on BCV.
This joint research is a nonclinical study that will evaluate the efficacy of BCV in a herpes simplex virus (HSV) infection modelusing a 3D (three-dimensional) brain model established by Tufts University.
In addition to having its strong antiviral effect, BCV also is expected to have an antitumor effect, and the Group is exploringnew indications such as EBV-positive lymphoma, refractory brain tumors, and other cancers via research collaborations with the
National Cancer Centre Singapore (NCCS) and 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/T-cell lymphoma―3―for which no effective treatment is currently available were presented by Dr. Jason Yongsheng Chan at the 64th American Societyof Hematology (ASH) Annual Meeting in New Orleans.
In September 2022, Chimerix announced that it has completed the closing of the sale of BCV to Emergent BioSolutions Inc.
(head office: Maryland, U.S.). The Group’s exclusive worldwide development, manufacturing, and marketing rights to BCV for
all indications except orthopox virus infections (including smallpox and monkeypox) will not be affected.
(iii) Business outside JapanThe Group appointed Dr. Carolyn Yanavich, President and Chief Operating Officer of SymBio Pharma USA, Inc., as Chief
Development Officer of the Group to further expand our global development structure and make SymBio Pharma USA, Inc. as thedriving force behind the international clinical trials, spearheading and accelerating the global development plan for BCV.
(iv) Licensing of new drug candidates
The Group is moving ahead with global development of brincidofovir, an antiviral drug in-licensed in 2019. At the same time, theGroup continues to evaluate new drug candidates for potential in-licensing. Through these efforts, the Group aims to create mediumto long-term business value as a profitable biopharmaceutical company with growth potential.

(2) Overview of financial position for the fiscal year under review(Assets, liabilities, net assets, and cash flows)
Total consolidated assets as of December 31, 2022 stood at 10,433 ,347 thousand yen. Current assets totaled 9,312,706 thousand
yen, mainly consisting of 6,282,554 thousand yen in cash and deposits, 2,084,915 thousand yen in accounts receivable-trade, 293,757
thousand yen in merchandise and finished goods, and 175,170 thousand yen in semi-finished goods. Non-current assets amounted to
1,120,641 thousand yen, mainly consisting of 744,728 thousand yen in deferred tax assets and 222,204 thousand yen in software.
Total liabilities stood at 1,927,255 thousand yen. Current liabilities totaled 1,923,870 thousand yen, mainly consisting of 1,163,721
thousand yen in accounts payable-other. Non-current liabilities amounted to 3,385 thousand yen, consisting of 3,385 thousand yen in
liabilities for retirement benefits.
Total net assets stood at 8,506,092 thousand yen. This mainly breaks down as 17,548,459 thousand yen in capital stock, 17,523,357
thousand yen in capital surplus, and 411,672 thousand yen in share acquisition rights.
As a result, the equity ratio was 77.6%.

―4―

(3) Overview of cash flows for the fiscal year under review
Cash and cash equivalents (hereinafter, “net cash”) stood at 6,282,554 thousand yen as of December 31, 2022.
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 1,614,241 thousand yen. The key drivers were 2,106,279 thousand yen in profit
before income taxes and a decrease of 62,594 thousand yen in receivable-trade. Cash outflows were mainly due to an increase of
270,711 thousand yen in consumption taxes receivable, an increase of 82,746 thousand yen in inventory.
(Cash flows from investing activities)
Net cash used in investing activities was 47,127 thousand yen, mainly attributable to purchase of intangible assets of 45,524
thousand yen.
(Cash flows from financing activities)
Net cash provided by financing activities was 627,985 thousand yen, mainly attributable to proceed from issuance of shares of662,000 thousand yen. in proceeds from issuance of shares.
18th Term
FY 2022Equity ratio (%)

77.6

Equity ratio on a fair market value basis (%)

243.6

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 2023 to decrease by 30.1% from FY 2022 to 7,000 million yen. While the Group aims tofurther expand the market share of TREAKISYM®, reduction in NHI drug prices and impact of generic products on sales of
TREAKISYM® are expected. In addition, the Group initiated litigation against the makers of the generic versions of
TREAKISYM® based on patent infringement. As the litigation process is not expected to conclude for some time, , potential
impact of the lawsuits on net sales is not included.
Regarding research and development, in addition to the global Phase II clinical trial for treatment of AdV infection with BCV
IV that started in 2021, the global Phase II clinical trial for treatment of post renal transplant BKV infection with BCV IV thatstarted in 2022 will be in full operation. Furthermore, in order to develop new indications through joint research with academia andto evaluate new drug development candidates with the aim of enhancing long-term corporate value, the Group expects R&D
expenses to increase to 3,380 million yen in FY 2023 (compared to 2,554 million yen in FY 2022), following the increase in FY
2022.
As a result, for the fiscal year ending December 31, 2023, the Group forecasts net sales of 7,000 million yen, operating loss of
331 million yen, ordinary loss of 351 million yen, and loss attributable to owners of parent of 370 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.
The license agreement concluded with Astellas Deutschland GmbH concerning the rights in Japan and other Asian countries
for the freeze-dried formulation of anticancer agent bendamustine has expired.
(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 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 high probability 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).
The oral formulation of rigosertib was shown to be effective and safe when administered in combination with azacitidine in a
Phase I/II clinical trial in first-line higher-risk MDS patients conducted by Onconova in the U.S. The Group commenced a Phase
I clinical trial in Japan to confirm the safety of high-dose monotherapy and tolerance in Japanese patients in Japan in June 2017,and completed patient enrollment in June 2019.
With the aim of maximizing the business value of rigosertib and TREAKISYM®, the Group is conducting joint research with
the University of Tokyo to investigate the efficacy of the drugs used in combination with each other as well as with other existing
drugs and to look for new indications.
(iii) [Antiviral drug: SyB V-1901 (generic name: brincidofovir [BCV])]On September 2019, the Group concluded an exclusive global licensing agreement for antiviral drug brincidofovir (“BCV”)―6―

with Chimerix Under this agreement, the Group acquired the exclusive rights for the worldwide development, marketing, andmanufacture of BCV for all human indications, excluding orthopox viruses.
The Group has decided to prioritize the global development of BCV, targeting adenovirus (AdV) infections occurring after
hematopoietic stem cell transplantation—a niche area with a high unmet medical need, and a Phase II clinical trial of BCV IV iscurrently being conducted.
Based on the knowledge and insight on the safety and efficacy of BCV obtained from the clinical trials targeting 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 and loss ofthe transplanted kidney (graft loss). The Group has commenced a Phase II clinical trial in patients infected with BKV after kidneytransplantation 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., BCV Oral has been shown to have strong antiviral activity against a broad
range of viruses. BCV Oral’s antiviral activity against a range of dsDNA viruses suggests that BCV IV may also be safe andeffective in the prevention and treatment of various viral infections following hematopoietic stem cell transplantation.
In December 2020, Chimerix announced that the FDA had accepted its NDA for BCV Oral as a medical countermeasureagainst smallpox; the NDA was approved in June 2021.

―7―

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.

―8―

3. Consolidated Financial Statements and Primary Notes(1) Consolidated balance sheet(Unit: thousands of yen)
FY 2022(as of December 31, 2022)
AssetsCurrent assets
6,282,554

Cash and deposits
Accounts receivable–trade

2,084,915
293,757

Merchandise and finished goods
Semi-finished goods

175,170452

Supplies
Advance payments

252,745
209,886

Prepaid expenses
Other

13,224
9,312,706

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

64,931

Accumulated depreciation(24,260)

Buildings, net

40,670Tools, furniture and fixtures
Accumulated depreciation

73,159(44,819)

Tools, furniture and fixtures, net

28,339Total property, plant and equipment

69,009Intangible assets
Software222,204

Total intangible assets

222,204

Investments and other assets
Deferred tax assets
Leasehold and guarantee deposits

744,728
84,698

Total investments and other assets

829,427

Total non-current assets

1,120,641
10,433,347

Total assets―9―

(Unit: thousands of yen)
FY 2022(as of December 31, 2022)
Liabilities
Current liabilities
Accounts payable–trade
Accounts payable–other

46,633
1,163,721

Income taxes payable
Provision for product changeover

401,066
16,331

Other296,118

Total current liabilities

1,923,870

Non-current liabilities
Liabilities for retirement benefits

3,385

Total non-current liabilities

3,385

Total liabilities

1,927,255

Net assets
Shareholders’ equity
Share capital

17,548,459

Capital surplus
Retained earnings

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

Treasury shares(88,154)
8,094,176

Total shareholders’ equity
Accumulated other comprehensive income
Foreign currency translation adjustment

243

Total accumulated other comprehensive income

243

Share acquisition rights

411,672
8,506,092

Total net assets
Total liabilities and net assets

10,433,347―10―

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

Cost of sales(Unit: thousands of yen)
FY 2022(from January 1, 2022
to December 31, 2022)
10,008,338
2,408,434

Gross profit

7,599,904

Selling, general and administrative expenses

5,636,278

Operating profit

1,963,625

Net sales

Non-operating income
Interest income
Foreign exchange gains

98
136,179

Other

2,925
139,204

Total non-operating income
Non-operating expenses

56,543

Commission expenses
Share issuance costs
Other45,867
540

Total non-operating expenses

102,951

Ordinary profit

1,999,878

Extraordinary income
Gain on reversal of share acquisition rights

106,401

Total extraordinary income

106,401
2,106,279

Profit before income taxes
Income taxes - current
Income taxes - deferred

396,010531,030

Total income taxes

927,041

Profit

1,179,238

Profit attributable to non-controlling interests－

Profit attributable to owners of parent

1,179,238―11―

Consolidated statements of comprehensive income

Profit(Unit: thousands of yen)
FY 2022(from January 1, 2022
to December 31, 2022)
1,179,238

Other comprehensive income
Foreign currency translation adjustment

198

Total other comprehensive income

198
1,179,437

Comprehensive income(Comprehensive income attributable to)1,179,437

Comprehensive income attributable to owners of parent
Comprehensive income attributable to non-controllinginterests－―12―(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

17,157,628

17,132,501

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(27,975,902)

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

Retainedearnings

44

44

Share
acquisitionrights519,099

Total net assets

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―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
Depreciation
Amortization of guarantee deposits
Share-based remuneration expenses

2,106,279
98,092
1,339
104,731609(171,081)(98)(370,416)
56,54345,867(106,401)
540
62,594(82,746)(64,874)

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

Interest income
Foreign exchange losses (gains)
Commission expenses
Share issuance cost
Gain on reversal of share acquisition rights
Loss on retirement of non-current assets
Decrease (increase) in trade receivables
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(270,711)(89,984)(23,050)
685,306(105,844)
157,769
2,034,463
98(56,543)(363,776)
1,614,241

Increase (decrease) in notes and accounts payable–trade

Increase (decrease) in accounts payable–other
Increase (decrease) in other current liabilities
OthersSubtotalInterest and dividends received
Commitment fee paid
Income taxes paid
Net cash provided by (used in) operating activities
Cash flows from investing activities
Purchase of property, plant and equipment
Purchase of intangible assets
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 fromexercise of share acquisition rights
Proceeds from issuance of share acquisition rights
Payments for issuance of shares
Proceeds from issuance of shares
Purchase of treasury shares
Proceeds from disposal of treasury shares
Net cash provided by (used in) financing activities(2,034)(45,524)432(47,127)
146
13,760(45,837)
662,000(2,165)
81
627,985
213,710
2,408,809
3,860,106

Effect of exchange rate change on cash and cash equivalents

Net increase (decrease) in cash and cash equivalents
Cash and cash equivalents at beginning of period
Increase in cash and cash equivalents resulting from
inclusion of subsidiaries in consolidation
Cash and cash equivalents at end of period

13,637
6,282,554―14―

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

(Changes in accounting policies)(Application of Accounting Standard for Revenue Recognition)
The Group has applied the “Accounting Standard for Revenue Recognition” (ASBJ Statement No. 29; March 31, 2020; hereinafter“Revenue Recognition Standard”) from the beginning of the fiscal year under review. As a result of the application of this standard,
revenue will be recognized in the amount expected to be received in exchange for the promised goods or services at the time controlof the promised goods or services is transferred to the customer.
Under the previous accounting standard, for transactions where the total amount of consideration the Group is entitled to inexchange for the transfer of promised goods or services, i.e., the transaction price, is likely to be reduced after a contract is signedwith the customer, the Group revised the transaction price once the amount to be reduced was fixed. However, under the new
accounting standard, the Group makes a reasonable estimate of the variable amount and subtracts it from the transaction price at thetime the goods or services are transferred to the customer. Further, under the previous accounting standard, the Group accounted for
expected sales returns by recording provisions for sales returns in the amount equivalent to gross profit; however, in accordance withthe provisions regarding variable consideration, the Group no longer recognizes revenue at the time of sale and records refund
liabilities as “other” under the current liabilities section of the balance sheet.
The Group has followed the transitional treatment prescribed in the provision of Paragraph 84 of the Revenue Recognition
Standard, and has applied the new accounting standard from the opening balance of retained earnings of the fiscal year under review,
whereby the cumulative effect of retrospective application of the new accounting standard prior to the beginning of the fiscal year
under review is added to or deducted from the beginning balance of retained earnings.
As a result, in the consolidated statements of income for the fiscal year under review, net sales increased by 62,962 thousand yen,operating profit and ordinary profit increased by 62,962 thousand yen, respectively, and profit before income taxes increased by
62,962 thousand yen. In addition, the balance of retained earnings at the beginning of the period decreased by 92,822 thousand yen.
(Application of Accounting Standard for Fair Value Measurement)
The Group has applied the “Accounting Standard for Fair Value Measurement” (ASBJ Statement No. 30; July 4, 2019; hereinafter“Fair Value Measurement Standard”) from the beginning of the fiscal year under review.
In applying the Fair Value Measurement Standard, the Group has followed the transitional treatment prescribed in the provisionof Paragraph 19 of the Fair Value Measurement Standard and Paragraph 44-2 of the “Accounting Standard for Financial Instruments”(ASBJ Statement No. 10; July 4, 2019), 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 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.

―15―

(Per share information)

FY 2022(from January 1, 2022
to December 31, 2022)
Net assets per share
204.83 yen
Net income per share
30.20 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)
Basic earnings per share
Profit attributable to owners of parent (thousands of yen)Amount not attributable to common shareholders(thousands of yen)
Profit attributable to owners of parent of common stock(thousands of yen)
Average number of common stock during the fiscal year
(shares)
Diluted earnings per share
Adjustment of profit attributable to owners of parent(thousands of yen)
Increase in shares of common stock (shares)(Of which, share acquisition rights) (shares)

1,179,238―
1,179,238
39,046,822―
558,585(558,585)

1 types of share acquisition
Outline of dilutive shares not included in the calculation of rights (20,000 units) in
diluted earnings per share because they have no dilutive effect accordance with theCompanies Act Article 236,
238, and 239.
(Significant subsequent events)
None to be reported.

―16―