English translation

March 24, 2021

Annual Report(January 1, 2020 through December 31, 2020)
1. Business Performance of SymBio Pharmaceuticals Limited(1) Business conditions and operating results
Progress in the Company’s business for the fiscal year under review is as follows.
(i) Domestic business[Establishment of the Company’s own sales organization]
With its business partnership agreement with Eisai Co., Ltd. (“Eisai”) set to expire in December
2020, SymBio began preparing to establish its own sales organization for the sale of TREAKISYM®
in Japan in October 2018.
In the fiscal year ended December 31, 2020 (hereafter “FY 2020”), the Company identified needsof each region and formulated detailed proposals to address these needs. In efforts to establish asalesforce with enhanced productivity, the Company assigned 53 medical representatives across thenation and nine hematology experts to each region of operation.
Further, to establish a nationwide distribution system, in September 2020 the Company concluded
basic agreements with Suzuken Co., Ltd. and Toho Pharmaceutical Co., Ltd. for the distribution ofpharmaceutical products, and after the partnership agreement with Eisai expired, began transactions
with these two companies as its sole wholesalers. For a nationwide logistics system, the Company
began collaborating with S.D. Collabo Co., Ltd and set up two logistics centers—one in Eastern andthe other in Western Japan.
Through these efforts, the Company established its own sales organization, and following the
expiration of its partnership agreement with Eisai, transitioned the sale of TREAKISYM® to its own
sales system in December 2020.
Achieving profitability in FY 2021 and sustaining earnings growth thereafter are important issues
for the Company, and with the transition to its own sales organization, its prospects for future growth
have become solid.
[Stable supply of products]
SymBio imports lyophilized powder formulation of TREAKISYM® from Astellas DeutschlandGmbH (“Astellas Deutschland”), a subsidiary of Astellas Pharma Inc. In the first half of FY 2020,
some batches imported from Astellas Deutschland were found to contain impurities and had
appearance defects, causing TREAKISYM® inventories at Eisai to trend at a lower level year-on-year.
However, in the second half of the fiscal year, the Company conducted secondary packaging and-1-

quality tests for a number of imported batches, bringing the Company’s inventory of the product backto its normal level.
The Company obtained manufacturing and marketing approval for the ready-to-dilute (RTD) liquid
formulation of TREAKISYM®, for which it entered an exclusive license agreement with Eagle
Pharmaceuticals Inc. (head office: New Jersey, U.S.) in September 2020. In the fourth quarter of FY
2020, we began importing and delivering to wholesalers the RTD formulation scheduled for market
launch in January 2021.
[Stable supply of products]
SymBio imports lyophilized powder formulation of TREAKISYM® from Astellas DeutschlandGmbH (“Astellas Deutschland”), a subsidiary of Astellas Pharma Inc. In the first half of FY 2020,
some batches imported from Astellas Deutschland were found to contain impurities and had
appearance defects, causing TREAKISYM® inventories at Eisai to trend at a lower level year-on-year.
However, in the second half of the fiscal year, the Company conducted secondary packaging andquality tests for a number of imported batches, bringing the Company’s inventory of the product backto its normal level.
In the fourth quarter of FY 2020, the Company obtained manufacturing and marketing approval forthe ready-to-dilute (RTD) liquid formulation of TREAKISYM®, for which it entered an exclusive
license agreement with Eagle Pharmaceuticals Inc. (head office: New Jersey, U.S.) in September 2020,and began importing and delivering to wholesalers the RTD formulation scheduled for market launchin January 2021.
(Note 1)

Non-Hodgkin’s lymphoma (NHL) refers to malignant lymphoma other than Hodgkin’s lymphoma.
Malignant lymphoma is a cancer of the lymphatic system in which lymphocytes develop malignant
growths. The majority of Japanese malignant lymphoma patients are suffering from NHL.

(Note 2)

Obinutuzumab (Gazyva®, marketed by Chugai Pharmaceutical Co., Ltd.): Like rituximab
recommended by treatment guidelines for non-Hodgkin’s lymphoma in Japan and overseas,
obinutuzumab is a glycoengineered type II anti-20 monoclonal antibody that directly binds to CD20
(a protein expressed on B-cells other than stem cells or plasma cells) on target B-cells to attack anddestroy them along with the body’s immune system.

(Note 3)Tumor-specific T-cell infusion therapy is a treatment method in which tumor-specific T-cells (T-cells
that specifically recognize cancer cells) taken from cancer patients are artificially bestowed withcancer specificity extracorporeally, amplified and then administered to the patient.

(Note 4)

Kymriah® intravenous infusion (generic name: tisagenlecleucel, marketed by Novartis Pharma K.K.):
Kymriah® intravenous infusion is the first chimeric antigen receptor T-cell (CAR-T) therapy
approved within Japan. Novartis Pharma received manufacturing and marketing approval for
Kymriah® for use in the treatment of CD19 positive relapsed/refractory B-cell acute lymphoblastic
leukemia (B-ALL) and CD19 positive DLBCL in March 2019. Kymriah® intravenous infusion was
included in NHI price listings in May 2019.

(Note 5)Chimeric antigen receptor T-cell (CAR-T) therapy is a type of tumor-specific T-cell infusion therapy
that introduces genes that code chimeric antigen receptors (CARs) into T-cells, amplifies these cells
and then infuses them. These chimeric antigen receptors are produced by combining the intracellulardomains of T-cell receptors with the antigen binding sites of antibodies capable of recognizing-2-

membrane antigens attached to tumor cells. In clinical trials using CARs to target CD19 that expresses
on B-cells, CD19-targeting CARs were introduced into T-cells that were later administered to patientswith B-cell tumors. These modified cells produced clear clinical effects.
(Note 6)Developed by Roche using Seattle Genetics’ antibody-drug conjugate (ADC) technology,
polatuzumab vedotin is a first-in-class anti-CD79b ADC (targeting CD79b) built by conjugating
humanized monoclonal antibody targeting CD79b to a tubulin polymerization inhibitor. CD79b
protein is specifically expressed on the surface of many B-cells, and is expected to be a promisingtarget in new drug development. Polatuzumab vedotin selectively binds to CD79b while minimallyaffecting normal cells, and destroys B-cells with the chemotherapeutic agent it contains.

(Note 7)

Ready-to-dilute (RTD) and rapid infusion (RI) are pre-dissolved liquid formulations that differ fromcurrently available lyophilized (freeze-dried) powder injection. RTD will significantly reduce thepreparation time and labor cost for healthcare providers, and RI will reduce infusion duration to 10
minutes from the current 60 minutes, providing significant benefit and value to both patients andhealthcare providers.

[Anticancer agents: SyB L-1101 (intravenous formulation) and SyB C-1101 (oral formulation) (genericname: rigosertib sodium)]
U.S. licensor Onconova Therapeutics, Inc. (head office: Pennsylvania, U.S., “Onconova”) is
conducting global Phase III clinical trials (with trial sites in more than 20 countries; INSPIRE study)of the intravenous formulation of rigosertib for higher-risk myelodysplastic syndromes (HR-MDS)
which failed to respond to the current standard treatment with hypomethylating agents, relapsed after
treatment under the current standard of care, or were intolerant to hypomethylating agents; the primary
endpoint of the study is overall survival. In August 2020, Onconova announced that the primary
endpoint—improved survival compared to physician’s choice of treatment—was not met. The
Company is responsible for clinical development in Japan, and is reviewing ways to use the findings
from additional analysis of the INSPIRE study in the future development of rigosertib.
As for the oral formulation of rigosertib, Onconova completed a Phase I/II clinical trial of theinvestigational drug (in combination with azacitidine (Note 8)) in the U.S. in first-line HR-MDS
patients, and the results suggested that the oral formulation of rigosertib and azacitidine used in
combination were safe and effective. In June 2017, the Company initiated a Phase I clinical trial in
Japan to confirm the safety and tolerability of high-dose monotherapy and tolerance in Japanesepatients, and completed patient enrollment in June 2019.
With the aim of maximizing the business value of TREAKISYM® and rigosertib, the Company
intends to conduct joint research with the Institute of Medical Science, the University of Tokyo, toinvestigate the efficacy of the drugs used in combination as well as used in combination with otherexisting drugs and look for new indications.
(Note 8)

Azacitidine (Vidaza®, marketed by Nippon Shinyaku Co., Ltd.): This hypomethylating agent (forinjection) was approved in 2011 upon successful confirmation of extended overall survival for the
first time in the Phase III clinical trial for the indication of MDS, and is currently used as a first-line
drug for MDS patients who have difficulties in hematopoietic stem cell transplantation. MDS is apreleukemic state, and decrease in tumor suppressor gene due to excessive methylation of DNA isthought to be related to the disease. Hypomethylating agents such as azacitidine are thought tosuppress progress to leukemia by restoring tumor suppressor gene with a deterrent effect against
methylation of DNA.

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[Antiviral drug: SyB V-1901 (generic name: brincidofovir)]
On September 30, 2019, the Company concluded an exclusive global licensing agreement for
intravenous and oral formulation of antiviral drug brincidofovir (Note 9) (SyB V-1901; “BCV IV” and“BCV Oral,” respectively) with Chimerix Inc. (head office: North Carolina, U.S., “Chimerix”). Under
this agreement, the Company acquired exclusive rights for the worldwide development, marketing,and manufacture of BCV for all human indications, excluding smallpox.
As a result of the review at the Global Advisory Board meeting convened in February 2020, theCompany decided to prioritize the global development of BCV IV targeting adenovirus (AdV)
infections occurring after hematopoietic stem cell transplantation, an area with high unmet medical
needs as there currently exists no effective treatment, primarily in Japan, the U.S., and Europe.
Leveraging its knowledge of the efficacy and safety of BCV obtained from clinical trials, the Company
plans to investigate the efficacy of BCV against a range of dsDNA (Note 10) viral infections andexpand target indications to include multiple viral infections occurring after hematopoietic stem celltransplantation. It also intends to pursue the possibility of expanding target indications of the drug toviral infections after kidney or other organ transplantation. Through these efforts, the Company aims
to expand the market for BCV and maximize its business value. Currently, the Company is preparing
to start clinical trials of BCV IV targeting AdV infections in children scheduled for FY 2021.
BCV Oral demonstrated highly active antiviral effects in clinical trials conducted in Europe and the
U.S. by Chimerix. These trials also confirmed that BCV Oral had broad-spectrum antiviral effects.
Based on these extensive antiviral effects of BCV Oral against various dsDNA viruses, the Company
expects BCV IV to be also effective and safe in the treatment and prevention of various viral infections
occurring after hematopoietic stem cell transplantation.
In December 2020, Chimerix announced that the U.S. Food and Drug Administration (FDA)
accepted its filing of a New Drug Application (NDA) for BCV as a medical countermeasure forsmallpox. The FDA granted BCV a priority review designation and based on the Prescription Drug
User Fee Act (PDUFA), set the PDUFA date for April 7, 2021.
(Note 9)

Brincidofovir (BCV) has a structure in which cidofovir (an antiviral drug already approved andmarketed in the U.S. and Europe, but unapproved in Japan; “CDV”) is bound to a lipid chain(hexadecyloxypropyl; “HDP”). It is quickly absorbed into the lipid bilayer membrane and efficiently
transferred into cells, and the bound lipid chain is metabolized and separated from the structure by
intracellular phospholipases. This process generates an activator (CDV-PP; CDV diphosphate) that is
retained in the cells for a long period of time, dramatically raising the compound’s antiviral activity.
Furthermore, BCV avoids nephrotoxicity, a fundamental issue plaguing CDV, since HDP conjugation
prevents the accumulation of the compound in renal tubular epithelial cells through organic aniontransporter 1 (OAT1) and CDV is released at low levels in the bloodstream.

(Note 10)

Double-stranded DNA (dsDNA) viruses include herpesviridae, adenoviridae, polyomaviridae,
papillomaviridae, poxviridae families of viruses, such as CMV, AdV, HHV-6, BK virus, HSV1/2,
VZV, HPV, JCV, and small pox virus.

[Patient-controlled analgesia SyB P-1501]
On October 11, 2017, SymBio initiated an arbitration against The Medicines Company (head office:
New Jersey, U.S., “MDCO”)—from whom the Company in-licensed SyB P-1501 (IONSYS in the-4-

U.S.) in October 2015—under the rules of the International Chamber of Commerce, seeking damagesof 82 million US dollars arising from MDCO’s decision to discontinue and withdraw IONSYS fromthe U.S. and European markets and failure to provide adequate assurances of MDCO’s performance
under the license agreement. On September 1, 2020, the Company announced that the arbitral tribunal
did not agree with the Company’s claim that MDCO failed to provide adequate assurances of
performance under the license agreement and denied the Company’s claim for damages. However, thearbitral tribunal awarded the Company 4,950,000 US dollars representing 50% of its legal fees andexpenses that it sought to recover in the arbitration.
(ii) Business outside Japan
SyB L-0501 is also marketed in South Korea, Taiwan, and Singapore, and product sales of SyB L0501 in these countries were in line with the Company’s forecasts.
(iii) Licensing of new drug candidates
SymBio plans to focus on formulating and executing plans for the global development of theantiviral drug brincidofovir in-licensed in September 2019 for the time being. However, the Company
will continue working on its existing initiatives of reviewing multiple licensing projects at all times
and searching and evaluating new drug candidates for potential in-licensing. Through these efforts, itaims to create long-term business value as a profitable biopharmaceutical company with growthpotential.
(iv) Business results
As a result of the above, net sales totaled 2,987,051 thousand yen for FY 2020, primarily reflecting
product sales of TREAKISYM®, and overall net sales increased 5.3% year on year.
Selling, general and administrative expenses totaled 5,373,073 thousand yen (+4.0% year on year).
This included research and development (“R&D”) expenses of 2,266,556 thousand yen (-7.2% year
on year), reflecting expenses associated with clinical trials for the intravenous formulation of
TREAKISYM® and the intravenous formulation of rigosertib, as well as other selling, general andadministrative expenses of 3,106,517 thousand yen (+14.0% year on year), reflecting upfront spendingfor establishing the internal sales organization.
As a result, an operating loss of 4,540,035 thousand yen was recognized for FY 2020 (an operating
loss of 4,301,615 thousand yen in the previous fiscal year). In addition, non-operating income was
2,585 thousand yen, primarily consisting of dividend income of insurance of 2,324 thousand yen.
Meanwhile, non-operating expenses were 112,268 thousand yen and primarily comprised commission
expenses of 43,958 thousand yen, foreign exchange losses of 41,287 thousand yen, and share issuancecost of 27,021 thousand yen. Consequently, ordinary loss totaled 4,615,903 thousand yen (an ordinary
loss of 4,376,655 thousand yen in the previous fiscal year) and bottom-line loss in FY 2020 totaled
4,090,216 thousand yen (a loss of 4,376,258 thousand yen in the previous fiscal year), partially offset
by the recording of settlement received of 525,124 thousand yen.

-5-

Segment information has been omitted since the Company operates within a single segment, which
includes the research and development, manufacturing, and marketing of pharmaceutical drugs andother related activities.

(v) Capital investment
The total amount of capital expenditures during the fiscal year under review was 148,932 thousand
yen, mainly consisting of office investments and the purchase of appliances, network devices, andbusiness software.
(2) Status of fund procurement
The company procured 4,255,230 thousand yen as a result of the exercise of share acquisition rights
associated with the 47th, 50th, and 51st warrants (with Exercise Price Revision Clauses) in the fiscal year
under review.
(3) Status of assets and profit and loss
(Unit: thousands of yen)
Fiscal year
Classification
Net sales
Operating profit (loss)
Ordinary profit (loss)
Profit (loss)
Loss per share (yen)Total assets
Net assets
Net assets per share (yen)FY 2017
The 13th Term

FY 2018
The 14th Term

3,444,206(3,947,061)(3,976,784)(3,977,862)(79.78)4,252,284
3,239,402
50.00

3,835,530(2,656,072)(2,748,730)(2,752,533)(165.54)
6,239,423
4,901,799
212.23

FY 2019
The 15th Term
2,837,753(4,301,615)(4,376,655)(4,376,258)(189.03)5,273,955
4,400,116
143.07FY 2020
The 16th Term(current)
2,987,051(4,506,220)(4,615,903)(4,090,216)(124.13)
6,274,707
4,657,318
105.76(Note) The Company conducted a 1-for-4 consolidation of common shares on July 1, 2019. Loss per share and net
assets per share and have been calculated based on the assumption that this consolidation was conducted at the
beginning of FY 2018.

(4) Issues to be addressed by the Company
The Company is committed to focusing on the following key management objectives.
(i) Further expansion of the pipeline
In order to enhance the enterprise value as a specialty pharmaceutical company, we need to expand
the pipeline through ongoing in-licensing of new drug candidates for development.
The Company is conducting or planning development of anticancer agents, including SyB L-0501,
SyB L-1101, SyB C-1101, SyB L-1701, and SyB L-1702, and an antiviral drug SyB V-1901. Currently
we are in discussion with counterparties regarding the in-licensing of several new drug candidates, andwill continue with active efforts to in-license new drug candidates for development in order to further
expand our pipeline.

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(ii) Life cycle management of products in the existing pipeline
In order to enhance the enterprise value, the Company believes that both in-licensing new drugcandidates and promoting product life cycle management are important. Therefore, it is critical tomaximize returns from each drug under development through indication expansion after the in-licensed
drugs’ initial approval.
TREAKISYM® is approved for manufacturing and marketing in Japan for the indications ofrelapsed/refractory low-grade non-Hodgkin’s lymphoma and mantle cell lymphoma, chronic
lymphocytic leukemia, and first-line treatment of low-grade non-Hodgkin’s lymphoma and mantle cell
lymphoma. TREAKISYM® also achieved primary endpoints in the Phase III clinical trial for the target
indication of relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL), and the Company
applied for approval to partially revise the manufacturing and marketing authorization in May 2020
for the additional indication. In addition, the Company in-licensed RTD and RI liquid formulations of
TREAKISYM® from Eagle Pharmaceuticals, Inc. (head office: New Jersey, U.S.) in efforts tomaximize the business value of TREAKISYM® by promoting the product life cycle management of
the product. For the RTD formulation, the Company obtained manufacturing and marketing approvalin September 2020, and launched the product in January 2021. For the RI formulation, the Company
is conducting clinical trials with the primary purpose of confirming the formulation’s safety.
The development of intravenous and oral formulations of rigosertib for the indication of
myelodysplastic syndromes (MDS) is underway. Few useful therapeutic agents are currently available
for MDS, so it is an area with a very high unmet medical need. With respect to the global Phase III
clinical trial (INSPIRE study) of the intravenous formulation conducted by Onconova, Onconova
announced that the primary endpoint—improved overall survival compared to physician’s choice oftreatment—had not been met. The Company is in charge of clinical development in Japan and isreviewing ways to utilize findings from the additional analysis of the INSPIRE study in future
development of rigosertib. Further, the oral formulation of rigosertib has been shown to be effective
and safe when administered in combination with azacitidine in the Phase I/II clinical trial in first-line
higher risk MDS patients conducted in the U.S. by Onconova. The Company commenced a Phase I
clinical trial in Japan to confirm the safety of high-dose monotherapy and tolerance in Japanese patientsin June 2017, and completed patient enrollment in June 2019.
With the aim of maximizing the business value of TREAKISYM® and rigosertib, the Company
intends to conduct joint research with the Institute of Medical Science, University of Tokyo, toinvestigate the efficacy of the drugs used in combination as well as used in combination with otherexisting drugs and look for new indications.
The Company has also decided to prioritize the global development of antiviral drug brincidofovir
primarily in Japan, the US, and Europe targeting adenovirus infections occurring after hematopoietic
stem cell transplantation, an area with a high unmet medical need. We will aim to maximize earnings
through managing the lifecycle of our products as we transform into a specialty pharmaceuticalcompany with the capacity to further expand in the global markets.
(iii) Preparation for the establishment of the Company’s own salesforce
With the business partnership agreement with its sales agent, Eisai, set to expire in December 2020,-7-

the Company began preparing to establish its own sales organization for the domestic sales of
TREAKISYM® in October 2018 and completed the process in FY 2020. Following the expiration ofits business partnership agreement with Eisai, the Company transitioned the sale of TREAKISYM® to
its own sales system in December 2020.
Providing specialized technical information will enable the Company to more accurately understandthe needs of the market and respond more swiftly, allowing it to contribute to the benefit of patients
while aiming to maximize the business value of TREAKISYM®. Furthermore, the Company strives tobuild a uniformed sales organization with a high level of specialization in the field of hematologicaldiseases. Through this effort, the Company aims to achieve high business efficiency, ensure sustainableearnings growth, and maximize shareholder gains once the intravenous and oral formulations ofrigosertib, which are currently under development to treat myelodysplastic syndromes (MDS), join
TREAKISYM® in the product lineup.
With regard to antiviral drug brincidofovir, we will not only pursue domestic sales, but also consider
global business development in all parts of the world, including Europe and the United States.
(iv) Global expansion for further growth
In addition to Japan, the Company identifies China, Hong Kong, South Korea, Taiwan, andSingapore as strategic regions in Asia to pursue further business development.
However, with expanding medical expenditures due to the aging population in Japan, and the adventof the “era of generic drugs comprising 80% of all drugs dispensed” as a governmental policy of Japan,
the business environment in Japan is expected to remain extremely challenging for innovative drug
developers. Such a policy may also be adopted by other Asian countries.
Under these circumstances, the Company will promote global expansion for further growth.
Utilizing its experience fostered through its business in Asia, the Company will search for, evaluate,
and negotiate for new drug candidates, whose rights can be acquired on a global scale, after the inlicensing of antiviral drug brincidofovir.
(v) Securing personnel
The Company places the highest priority on personnel as the Company’s principal management
resource. Without talent, we would be unable to achieve superior results in terms of exploring,developing, and providing information concerning new drugs, and unable to develop andcommercialize these new drugs on a global scale. We continually recruit talents. Especially after being
listed, we have recruited the best and brightest people in order to strengthen the management
organization. Going forward, we plan to further strengthen our human resources by providing on-thejob training and employee development programs.
(vi) Financial
It is necessary for the Company to raise funds required for business activities such as R&D
expenditures as pipeline development and global business expansion progress and as drug candidates
increase in number.
Therefore, we make every effort to further strengthen the financial base by continually diversifying-8-the method of fund raising and curtailing costs through tight budget control.

-9-(5) Major business activities (as of December 31, 2020)
The Company regards underserved therapeutic areas that lack the development of new drugs, despite
significant unmet medical needs, as business opportunities. We develop new drugs with a primary focus on
the treatment of rare diseases, mainly in the areas of oncology, hematology, and multiple viral infections,and conduct integrated business activities that encompass search for new drug candidates, development,
manufacturing, and sales.
(6) Main office and employees(i) Main office (as of December 31, 2020)
Name

Location

Main office

Minato-ku, Tokyo(ii) Employees (as of December 31, 2020)
Classification

Number of
employees

Increase or decrease
Average number offrom previous fiscal Average age (years)
years of service
year end
15 (increase)
49.8
3.2

Male

95

Female32

5 (increase)

46.1

4.4

Total or average

127

20 (increase)

48.8

3.5

(Notes) 1. Number of employees refers to full time employees.
2. The above number of employees does not include 48 temporary staff.

(7) Status of parent company and significant subsidiaries
Not applicable.
(8) Status of main lenders (as of December 31, 2020)
Not applicable.

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2. Matters Related to Stock (as of December 31, 2020)(1) Total number of authorized shares
Common stock: 41,750,000 shares(2) Total number of shares outstanding
Common stock: 38,172,813 shares (excluding 30,143 shares of treasury stock)(3) Number of shareholders
33,913(4) Major shareholders (10 largest)
Name of shareholder
Kyoichi Kageyama
Fuminori Yoshida
SBI Securities Co Ltd.
Cephalon, Inc.
Arata Takahashi
Norihiro Kuroda
Matsui Securities Co., Ltd.
Fumishige Ehira
Hitoshi Imamura
Eisai Co., Ltd.

Number of shares held
1,020,000
900,000
744,310647,250534,000
447,500
310,600
270,200
239,300
208,350

Shareholding ratio
2.7%
2.4%
1.9%
1.7%
1.4%
1.2%
0.8%
0.7%
0.6%
0.5%

(Notes) Shareholding ratio (%) indicates the percentage of shares outstanding held. Shares outstanding is equal to thenumber of shares issued minus treasury shares.

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3. Matters Related to Share Acquisition Rights(1) Share acquisition rights held by the Company’s Officers that were issued as compensation forservices (as of December 31, 2020)
The 24th warrant
The 26th warrant
The 30th warrant
by resolution of the Ordinary by resolution of the Board of by resolution of the Board ofGeneral Meeting of
Directors meeting
Directors meeting
Shareholders
on April 17, 2012
on May 14, 2013
on March 30, 2011
Number of shareacquisition rights

1,920 units

3,625 units

1,160 units

48,000 shares

90,625 shares

29,000 shares

Amount paid for shareacquisition rights

None

None

None

Value of property to becontributed upon theexercise of each shareacquisition right (Note 1)

2,728 yen per share

2,220 yen per share

3,196 yen per share

Period in which exercise ofshare acquisition rights ispossible

From: March 31, 2013
To: March 30, 2021

From: April 18, 2014
To: April 17, 2022

From: May 15, 2015
To: May 14, 2023

Status of possession by
Directors (excluding
Outside Directors) (Note 4)

1,200 units (1 holder)
30,000 shares

2,600 units (1 holder)
65,000 shares

645 units (1 holder)
16,125 shares

Status of possession by
Outside Directors

—

—

—

Number of shares to beissued upon the exercise ofshare acquisition rights (Note4)- 12 -

The 40th warrant
The 43rd warrant
The 48th warrant
by resolution of the Board of by resolution of the Board of by resolution of the Board of
Directors meeting
Directors meeting
Directors meetingon March 29, 2017
on March 29, 2018
on March 28, 2019
Number of shareacquisition rights

2,800 units

3,050 units

3,150 units

70,000 shares

76,250 shares

78,750 shares

20,300 yen per unit

19,800 yen per unit

19,400 yen per unit

1 yen per share

1 yen per share

1 yen per share

Period in which exercise ofshare acquisition rights ispossible

From: March 30, 2020
To: March 29, 2027

From: March 30, 2021
To: March 29, 2028

From: March 30, 2022
To: March 29, 2029

Status of possession by
Directors (excluding
Outside Directors) (Note 4)

1,450 units (1 holder)
36,250 shares

1,450 units (1 holder)
36,250 shares

1,400 units (1 holder)
35,000 shares

Status of possession by
Outside Directors (Note 4)—

250 units (1 holder)
6,250 shares

500 units (2 holders)
12,500 shares

Number of shares to beissued upon the exercise ofshare acquisition rights (Note4)

Amount paid for shareacquisition rights (Note 2) (Note4)

Value of property to becontributed upon theexercise of each shareacquisition right (Note 1)- 13 -

The 52nd warrant
by resolution of the Board of
Directors meetingon March 26, 2020
Number of shareacquisition rights

4,600 units

Number of shares to beissued upon the exercise ofshare acquisition rights

115,000 shares

Amount paid for shareacquisition rights (Note 2)

8,100 yen per unit

Value of property to becontributed upon theexercise of each shareacquisition right1 yen per share

Period in which exercise ofshare acquisition rights ispossible

From: March 27, 2023
To: March 26, 2030

Status of possession by
Directors (excluding
Outside Directors)

3,800 units (2 holders)
95,000 shares

Status of possession by
Outside Directors

800 units (2 holders)
20,000 shares(Notes) 1. New shares were issued through the public offering on December 4, 2013, and third-party allotment on
December 25, 2013, at the paid-in amount less than the value of property to be contributed upon the exerciseof each share acquisition right. Therefore, the stated value of property to be contributed upon the exerciseof each share acquisition right excluding those issued for the 32nd warrant and thereafter is adjusted inaccordance with the adjustment provision.
2. The person who receives the allotment of share acquisition rights shall offset the amount to be paid for the
relevant share acquisition rights against cash compensation equivalent to the amount.
3. There are no share acquisition rights held by Audit & Supervisory Board Members.
4. The Company conducted a 1-for-4 consolidation of common shares on July 1, 2019. Number of shares tobe issued upon the exercise of share acquisition rights and exercise price have been adjusted accordingly.

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(2) Share acquisition rights distributed to the Company’s employees as compensation for services
during the fiscal year under review (as of December 31, 2020)
The 53rd warrant
by resolution of theBoard of Directors
meeting on March 26,
2020
Number of shareacquisition rights

15,000 units

Number of shares to beissued upon the exercise ofshare acquisition rights

375,000 shares

Amount paid for shareacquisition rights (Note 2)

8,100 yen per unit

Value of property to becontributed upon theexercise of each shareacquisition right1 yen per share

Period in which exercise ofshare acquisition rights ispossible
Status of allotment to theCompany’s employees(Note 1)

From: March 27, 2023
To: March 26, 2030
11,910 units (107holders)
297,750 shares(Notes) 1. Of the share acquisition rights mentioned above, 3,090 units (77,250 shares) have been forfeited due tothe retirement or resignation of employees.
2. The person who receives the allotment of share acquisition rights shall offset the amount to be paid forthe relevant share acquisition rights against cash compensation equivalent to the amount.

(3) Other important matters concerning share acquisition rights
Not applicable.

- 15 -

4. The Company’s Officers (as of December 31, 2020)(1) Names of Directors and Audit & Supervisory Board Members
Company position

Responsibility and significant concurrent
position

Name

Representative Director

Fuminori Yoshida

Chief Executive Officer

Director

Shigeo Kimura

Director, Managing Senior Executive
Officer, and Head of the Japan Business Unit

Director

Shigetoshi Matsumoto

Director

Bruce David Cheson

Scientific Advisory Board, Lymphoma
Research Foundation

Full-time Audit & Supervisory
Kiyoshi Watanabe
Board Member
Audit & Supervisory Board
MemberKesao Endo

Audit & Supervisory Board
Member

Eiji Ebinuma

Representative, Endo C.P.A Firm
Outside Director, Careerlink Co., Ltd.
Representative Partner, ABS Audit Corp.
Partner, Tanabe & Partners Law Firm
Outside Director, Rakuten Bank, Ltd.
Audit & Supervisory Board Member, Toko
Electrical Construction Co., Ltd.

(Notes) 1. Of the Directors, Shigetoshi Matsumoto, Bruce David Cheson, and Rockford Douglas Norby are Outside
Directors.
2. Kiyoshi Watanabe, Kesao Endo, and Eiji Ebinuma are outside members of the Audit & Supervisory Board.
3. Shigetoshi Matsumoto, Kiyoshi Watanabe, and Kesao Endo have been designated as independent officers
pursuant to the provisions of the Tokyo Stock Exchange and registered as such with the Tokyo Stock
Exchange.
4. Kesao Endo possesses deep insight in finance and accounting, which he gained through his profession asa certified public accountant.
5. Eiji Ebinuma is an attorney with specialized knowledge and extensive experience in law.
6. Changes in Directors and Audit & Supervisory Board Members during the fiscal year under review are as
follows:- Director Kenji Murata resigned on January 31, 2020. Mr. Murata had held the post of Director, Corporate
Officer, and CFO.
- Director Rockford Douglas Norby passed away on April 13, 2020, and has therefore resigned. During his
term in office, Mr. Norby also held a significant concurrent position as an Outside Director at Krystal
Biotech, Inc.
7. The Company has adopted the Corporate Officer System. The Corporate Officers who do not holdconcurrent positions as Directors are as follows:
Corporate Officer Takaaki Fukushima(2) Summary of the contents of the liability limitation agreement
The Company has executed an agreement with each Director (excluding those who engage in businessexecution) and each member of the Audit & Supervisory Board with respect to the liability in Article 423,
Paragraph 1 of the Companies Act, setting forth that director liability will be limited to the higher of
1,000,000 yen or the maximum liability amount set forth in laws and regulations in cases where the Director
or member of the Audit & Supervisory Board has performed their duties in good faith and without grossnegligence.

- 16 -

(3) Directors and Officers Liability Insurance Policies
The Company has obtained Directors and Officers Liability Insurance Policies covering the Directors andAudit & Supervisory Board Members of the Company and its subsidiaries.
The aforementioned insurance is payable as indemnification for losses suffered by the insureds as a resultof a legal action brought for alleged wrongful acts in their capacity as directors and officers.
Costs of premiums paid on the aforementioned insurance are borne entirely by the Company.
(4) Compensation of members of the Board of Directors and the Audit & Supervisory Board
Number of Directors or
Total Amount of Compensation
Company Board
Audit & Supervisory Board(thousands of yen)
Members Paid
6
97,512
Board of Directors(Outside: 3)(Outside: 19,227)
3
21,592
Audit & Supervisory Board(Outside: 3)(Outside: 21,592)
9
119,105
Total(Outside: 6)(Outside: 40,820)(Notes) 1. Salary in the event of a Director doubling as an employee is not included in the above compensation for
Directors.
2. The maximum amount of compensation for Directors was resolved as an annual amount of 130 million
yen at the Extraordinary General Meeting of Shareholders held on August 3, 2005. In addition to theaforementioned compensation, it was resolved that compensation for Directors in the form of shareacquisition rights as stock options be granted up to a maximum annual amount of 80 million yen at the 8th
Ordinary General Meeting of Shareholders held on March 28, 2013. (Of 80 million yen, 30 million yen
was granted for Outside Directors, which was resolved at the 11th Ordinary General Meeting of
Shareholders held on March 30, 2016.)
3. The maximum amount of compensation for Audit & Supervisory Board Members was resolved as anannual amount of 30 million yen at the Extraordinary General Meeting of Shareholders held on June 30,
2011.
4. The number of Directors or Audit & Supervisory Board Members compensated as stated above includes
one (1) Director who resigned on January 31, 2020, and one (1) Director who passed away, and thereby
resigned on April 13, 2020.
5. The total compensation paid includes expenses (for five (5) Directors, a total of 35,383 thousand yen) in
connection with share acquisition rights as stock options for the fiscal year under review.

- 17 -

(5) Matters Concerning Outside Directors and outside members of the Audit & Supervisory Board
Status of main activities during the fiscal year under review
Position

Name

Status of
Status of attendance
attendance at theat the Audit &Board of Directors Supervisory Board
meetings
meetings

Opinions at the Board of Directors
meetings and the Audit & Supervisory
Board meetings

Director

Shigetoshi
Matsumoto

13 out of 13(100%)—Mr. Matsumoto expressed opinions froman objective perspective independent
from the Company’s management
engaged in business operations,leveraging his extensive knowledge andexperience with the business practices ofcompanies in the same industry and withauditing work.

Director

Bruce David
Cheson13 out of 13(100%)—

Dr. Cheson expressed opinions from an
objective perspective independent fromthe Company’s management engaged inbusiness operations, leveraging his
extensive knowledge and experience as aphysician.

Director

Rockford
Douglas Norby

3 out of 4
(75%)

—

Dr. Norby expressed opinions from an
objective perspective independent fromthe Company’s management engaged inbusiness operations, leveraging his
extensive experience and knowledge
regarding healthcare companies.

Full-time
Kiyoshi
Audit &
WatanabeSupervisory
Board Member

13 out of 13(100%)

14 out of 14(100%)

Mr. Watanabe actively expressed
opinions from an objective and fair
perspective based on his extensive
experience and knowledge as an audit &supervisory board member at listedcompanies in order to achieve highly
effective managerial supervision.

Audit &
Kesao Endo
Supervisory
Board Member

13 out of 13(100%)

14 out of 14(100%)

Mr. Endo actively expressed opinionsfrom a neutral perspective based on thespecialized knowledge and extensive
experience he accumulated as a certified
public accountant in order to achieve
highly effective managerial supervision.

Audit &
Eiji Ebinuma
Supervisory
Board Member

13 out of 13(100%)

14 out of 14(100%)

Mr. Ebinuma actively expressed opinionsfrom a neutral perspective based on thespecialized knowledge and extensive
experience he accumulated as an attorney
in order to achieve highly effective
managerial supervision.

(Note) With regard to Director Rockford Douglas Norby, his attendance at the meetings is calculated from theBoard of Directors meetings and the Audit & Supervisory Board meetings held up until his retirement inApril, 2020.

- 18 -

5. Status of Accounting Auditor(1) Name of accounting auditor
Ernst & Young ShinNihon LLC(2) Summary of the contents of the liability limitation agreement
Not applicable.
(3) Amount of compensation
Amount paid
Amount of compensation paid to the accounting auditor concerning the
fiscal year under review
Total amount of monetary and other property benefits to be paidby the Company

27,000 thousand yen
27,000 thousand yen(Notes) 1. Reasons for the Audit & Supervisory Board’s approval of the amount of compensation to be paid to theaccounting auditor
The Audit & Supervisory Board verified the contents of the audit planning by the accounting auditor,
performance of its duties in previous years, and status of planning and actual performance, and as a resultof a careful review on the adequacy of the amount of compensation for the fiscal year under review, hasapproved the amount of compensation to be paid to the accounting auditor, pursuant to the provisions ofArticle 399, Paragraph 1 of the Companies Act.
2. The amounts of compensation for audits paid in accordance with the Companies Act, and the audits
conducted in accordance with the Financial Instruments and Exchange Act, are not distinguished in thecontract agreement between the Company and the accounting auditor. It is not possible to distinguishbetween compensation paid for these two types of audits; therefore the total amount thereof is stated.

(4) Policies for dismissal or non-reappointment of the accounting auditor
When it is deemed necessary to dismiss (or not reappoint) the accounting auditor for reasons relating to
the accounting auditor’s execution of duties, the Audit & Supervisory Board shall determine the contents ofa proposal to be presented to a General Meeting of Shareholders in respect of the dismissal (or nonreappointment). In addition, when the accounting auditor falls under any of the items of Article 340,
Paragraph 1 of the Companies Act, the Audit & Supervisory Board shall dismiss the accounting auditor withthe consent of all members of the Audit & Supervisory Board. If this is the case, an Audit & Supervisory
Board Member selected by the Audit & Supervisory Board shall report the dismissal of the accounting
auditor and the reasons for such dismissal at the first General Meeting of Shareholders convened after thedismissal.

- 19 -

6. System to Ensure the Appropriateness of Operations(1) The corporate system to ensure that Directors, officers, and employees comply with laws andordinances, as well as the Articles of Incorporation, in the process of performing their duties(i) Dissemination and thorough implementation of management philosophy
In order to implement its management philosophy, the Company has established a Corporate Action
Charter and standards of conduct to which all Company members are expected to adhere. The
Company informs all executives and staff regarding these policies and asks for each member’s
understanding regarding the spirit of these regulations and for thorough compliance with the same. All
business activities of the Company are based on the premise of compliance with laws and ordinances
and the maintenance of corporate ethical standards (below, “compliance”).
(ii) Establishment of internal control committee
The Company develops internal control systems and employs other measures to support thoroughcompliance, risk management, and financial reporting. In addition, an internal control committee has
been established to ensure complete observance of laws and ordinances, the Articles of Incorporation,and other internal regulations through exhaustive supervision.
(iii) Establishment of internal audit office
The Company has established an internal audit office as an independent unit which conducts regular
audits and related activities under the direct authorization by the Representative Director and President.
Through such audits, objective assessments are made as to the effectiveness and efficiency of business,the reliability of various financial reports, safeguarding of assets, compliance status of operations, andthe appropriateness and effectiveness of corporate risk management policies. When necessary, theCompany ensures the efficacy of internal controls by accepting advice and proposals concerning
recommended improvements to the maintenance and operation of systems.
(iv) Establishment of compliance reporting and consultation hot-lines
The Company has established compliance reporting and consultation hot-lines both internal to andoutside the Company, and has designated compliance liaisons to respond to reports and requests for
consultation from employees, and to identify and resolve any compliance issues at the earliest stage
possible.
(v) Systems for securing reliable financial reporting
The Company establishes internal control systems and oversees their appropriate operation in orderto ensure reliable financial reporting.
(2) Corporate system for maintenance and control of information regarding the performance of
duties by Directors
The Company appoints an individual to be responsible for the general management of corporate
documents and to appropriately maintain and otherwise control all important documents containing
information as to the performance by Directors of their duties in addition to legally required records ofproceedings of Shareholders meetings and Board of Directors meetings, as provided in laws andordinances as well as in the Company’s own “Rules for the Management of Documents.”- 20 -

(3) Corporate system for control of risk of loss, including in-house rules for such control
The Company practices risk control under its basic risk control policy and related rules. The Internal
Control Committee is responsible for the supervision and promotion of risk management. Additionally,
the Company will swiftly respond to emergency situation by establishing an emergency response
headquarters managed by the Representative Director and President.
(4) Corporate system to ensure the efficient performance of duties by Directors(i) Directors and employees perform their duties in appropriate and efficient accordance with the “Rules
for the Board of Directors” and “Rules for the Internal Approvals,” as well as other related regulations.
(ii) The Company regularly holds Executive Management Committee meetings pursuant to the “Rules for
the Executive Management Committee” and reviews key proposals for the purpose of supporting
careful and timely decision-making from the Representative Director and President.
(iii) The Company develops mid- to long-term business plans and operates and expands its business inaccordance with these plans. In addition, the Company establishes numerical targets within its businessplans for each fiscal year and, through monthly closings, manages progress toward these targets while
making relevant reports to Directors.
(5) Basic policy against anti-social forces
The Company resolutely opposes anti-social forces that pose a threat to the order or safety of society
and forbids their participation in any and all business activities.
(6) Assistant to Audit & Supervisory Board Members
Audit & Supervisory Board Members may request that the Representative Director and President
appoint an employee to act as an assistant to Audit & Supervisory Board Members. Upon receiving sucha request, the Representative Director and President shall make an appropriate appointment.
(7) Ensuring the independence of assistants to Audit & Supervisory Board Members from Directors
and the effectiveness of the Audit & Supervisory Board Members’ instructions to employees(i) Assistants to Audit & Supervisory Board Members shall not receive instructions concerning theirsupporting duties from anyone other than Audit & Supervisory Board Members.
(ii) Matters such as personnel evaluation and transfer and disciplinary actions concerning employees thatassist Audit & Supervisory Board Members shall be subject to the prior consent of the Audit &Supervisory Board.
(8) Corporate system for Directors and employees to report to the Audit & Supervisory Board;
corporate system for other reports to the Audit & Supervisory Board; and corporate system toensure the efficient performance of audits by the Audit & Supervisory Board(i) Any Director or employee shall promptly inform the Audit & Supervisory Board if and when he/she
becomes aware of any circumstance that threatens to cause any significant damage to, or could
adversely affect, the Company.
(ii) Audit & Supervisory Board Members may participate in all matters that they consider important in- 21 -

terms of gaining a better understanding of decision-making processes, conditions, and statuses of theCompany’s businesses. Accordingly, they may attend Board of Directors meetings, Executive
Management Committee meetings, and other important meetings and are also permitted to view key
decision-making documents related to these meetings.
(iii) Audit & Supervisory Board Members may individually interview Directors and employees in key
positions of responsibility to obtain information regarding the management conditions of theCompany’s businesses.
(iv) Audit & Supervisory Board Members will regularly exchange opinions with the Representative
Director and President and the accounting auditor.
(v) The Company will not apply any sort of unfavorable treatment or unjust punishment to individuals
who make reports to the Audit & Supervisory Board.
(9) Matters related to the treatment of expenses or obligations associated with the execution of duties
of Audit & Supervisory Board Members, including the procedures for prepayment or
reimbursement of such expenses(i) The Company will respond without delay to claims for the prepayment of expenses made by Audit &Supervisory Board Members under Article 388 of the Companies Act, accepting responsibility for
associated expenses and processing related obligations, except in cases in which these have been
determined unnecessary for the execution of the duties of Audit & Supervisory Board Members.
(ii) The Company authorizes and shoulders expenses incurred when Audit & Supervisory Board Members
seek opinions or advice from external experts, including attorneys and certified public accountants, if
it is found necessary for the execution of their duties.

- 22 -

7. Summary of the Status of System to Ensure the Appropriateness of Operations(1) The Company is striving to foster a culture of compliance across the organization and ensure appropriate
operation of internal control systems through its communications with Directors and employees, andthrough publication of information such as the basic policies regarding internal control systems,
corporate compliance conduct principles, basic risk control policies, and the whistleblowing systemmanual on the Company’s intranet bulletin board.
(2) At the Board of Directors meetings of the Company, Outside Directors participate in resolutions froman independent standpoint and monitor and supervise the management. Each Audit & Supervisory Board
Member carries out management audits as well.
(3) Full-time Audit & Supervisory Board Members attend important meetings such as the Board of
Directors meetings as well as Executive Management Committee meetings, and exchange views withrepresentative directors monthly.

- 23 -

Balance Sheet(As of December 31, 2020)
Item(Assets)
Current assets
Cash and deposits
Accounts receivable–trade
Merchandise and finishedgoods
Supplies
Advance payments–trade
Prepaid expenses
Consumption taxes receivable

AmountItem

5,815,292
3,848,626
406,988944,442482
43,49480,645
314,761

Other

175,852

Non-current assets
Property, plant and equipment
Buildings
Tools, furniture and fixtures
Accumulated depreciation
Intangible assets
Software
Software in progress
Investments and other assets

459,415
76,701
59,12390,043(72,464)
301,841
296,005
5,836
80,871

Shares of subsidiaries andassociates
Leasehold and guarantee
deposits
Total assets

0(Liabilities)
Current liabilities
Accounts payable–trade
Unearned revenue
Accounts payable–other
Income taxes payable
Other
Non-current liabilities
Provision for retirement
benefits
Total liabilities(Net assets)
Shareholders’ equity
Capital stock
Capital surplus
Legal capital surplus
Other capital surplus
Retained earnings
Other retained earnings
Retained earnings brought
forwardTreasury shares

80,871

6,274,707(Unit: thousands of yen)AmountShare acquisition rights

1,615,339
665,460
192,705
645,81381,92829,4312,050
2,050
1,617,389
4,037,177
17,044,943
17,019,485
17,014,943
4,541(30,009,713)(30,009,713)(30,009,713)(17,538)
620,140

Total net assets

4,657,318

Total liabilities and net assets

6,274,707(Note) Amounts of less than one thousand yen are rounded down.

- 24 -

Statement of Income
January 1, 2020
( toFrom
December 31, 2020 )Item(Unit: thousands of yen)AmountI. Net sales

2,987,051

II. Cost of goods sold

2,120,198

Gross profit
III. Selling, general and administrative expenses

866,853
5,373,073

Operating loss
IV. Non-operating income
Interest income
Dividend income of insurance(4,506,220)
137
2,324

Interest on tax refund
Other

120
2

V. Non-operating expenses
Commission fee

43,958

Share issuance cost
Foreign exchange losses

27,021
41,287

Ordinary loss

2,585

112,268(4,615,903)

VI. Extraordinary income
Gain on reversal of share acquisition rights

4,341

Settlement received

525,145

529,486

Loss before income taxes
Income taxes–current

3,800(4,086,416)
3,800(4,090,216)

Net loss(Note) Amounts of less than one thousand yen are rounded down.

- 25 -

Statement of Changes in Equity
January 1, 2020
( Fromto December 31, 2020 )(Unit: thousands of yen)

Shareholders’ equity
Capital surplus

Capital stock

Balance as of January 1, 2020

Retained earnings
Other retained
earnings
Legal capital
Other
Total capitalsurpluscapital surplus
surplusRetained earnings
brought forward

14,870,639

14,840,639

2,174,304

2,174,304

2,498

14,843,137(25,919,496)

Changes of items during period
Issuance of new shares(exercise of share acquisitionrights)2,174,304

Net loss(4,090,216)

Purchase of treasury shares
Disposal of treasury shares

2,043

2,043

Net changes of items other thanshareholders’ equity
Total changes of items
during period

2,174,304

2,174,304

2,043

2,176,347(4,090,216)

Balance as of December 31,
2020

17,044,943

17,014,943

4,541

17,019,485(30,009,713)- 26 -

Shareholders’ equity
Treasury shares
Balance as of January 1, 2020

Total shareholders’equity(15,077)3,779,202

Share
Acquisitionrights620,913Total
net assets
4,400,116

Changes of items during period
Issuance of new shares(exercise of share acquisitionrights)4,348,608

4,348,608

Net loss(4,090,216)(4,090,216)

Purchase of treasury shares(6,387)(6,387)(6,387)

Disposal of treasury shares

3,926

5,969

5,969

Net changes of items other thanshareholders’ equity

(772)

(772)

Total changes of items during
period(2,461)

257,974(772)

257,201

Balance as of December 31, 2020

(17,538)

4,037,177

620,140

4,657,318(Note) Amounts of less than one thousand yen are rounded down.

- 27 -

Notes to Non-Consolidated Financial Statements(Significant accounting policies)(1) Valuation basis and method of marketable and investment securities
Marketable and investment
securities
Shares of subsidiaries andaffiliates

Shares of subsidiaries are stated at cost determined by themoving-average method.

Other marketable and investment
securities
Available-for-sale securities
with determinable market value

Available-for-sale securities with a determinable market
value are stated at fair value based on marketable value on
the closing date and other premises. Any valuationdifferences are included directly in shareholders’ equity.
Cost of securities sold is calculated by the moving-averagemethod.

Available-for-sale securities
without determinable market
value

Available-for-sale securities without determinable market
value are stated at cost determined by the moving-averagemethod.

Derivative transactions

Derivative financial instruments are stated at fair value.

Inventories

Inventories are stated at cost determined by the weightedaverage method. The amount on the balance sheet is
calculated by reducing book value when the contribution of
inventories to profitability declines.

(2) Depreciation and amortization of non-current assets
Property, plant and equipment(excluding lease assets)

Depreciation of property, plant and equipment is computedby the straight-line method.
The useful lives of major property, plant and equipment aresummarized as follows:
Buildings
3 to 18 years
Tools, furniture and fixtures
4 to 20 years

Intangible assets(excluding lease assets)

Amortization of intangible assets is computed by thestraight-line method.
Capitalized software costs are being amortized over theperiod of the internal use of five years.

Lease assets

Depreciation of lease assets is computed by the straight-line
method over the lease term with no residual value.

- 28 -

(3) Deferred assets
Share issuance costs andbond issuance costs

Share issuance costs and bond issuance costs are recorded as
expenses in full at the time of expenditure.

(4) Basis for translating assets and liabilities denominated in foreign currencies into Japanese yen
Monetary assets and liabilities denominated in foreign currencies are translated into Japanese yen at
the spot exchange rates prevailing on the closing date, and resulting gains or losses are credited or charged
to income.
(5) Basis for reserves and provisions
Provision for retirement
benefits

The provision for retirement benefits is provided based on an
estimated amount for retirement benefit obligations at the end of
fiscal year under review.
The Company applies the simplified method to calculate amounts
of provision for retirement benefits and retirement benefit
expenses. That is, the amount of retirement benefit obligations are
the payments required for voluntary retirement as of each fiscal
year end.

(6) Accounting for consumption tax
Transactions are recorded at amounts exclusive of consumption tax.
(Changes in presentation methods)(Balance sheet items)
Advance payments–trade, which were 2,177 thousand yen and included in the Other line of Current
assets for FY 2019, have increased in importance, and are therefore presented as a separate line item for
FY 2020.
(Additional information)(Overdraft and commitment line contracts)
The Company has overdraft and commitment line contracts with three banks in a business relationshipto efficiently procure working capital. The status of the bank overdraft and loan commitments based on thesecontracts at the end of the fiscal year under review is as follows:(Unit: thousands of yen)
Total amounts of bank overdraft limit and loan commitment line
3,150,000
Balance of borrowing outstanding—
Unused balance
3,150,000(Impact of COVID-19)
The outbreak of COVID-19 has made the outlook for the business environment more unpredictable. The
pandemic has led to changes in patient behavior and rescheduling of treatments, in addition to which a
number of hospitals continue to have visitor restrictions in place. Such impacts are considered in our asset- 29 -

impairment indicator assessment and are reflected in the estimates report.
(Balance sheet)
Monetary assets receivable from subsidiaries are as follows.
Short-term monetary assets receivable:
1,807 thousand yen(Statement of income)(1) Inventories at fiscal year-end are stated after writing down based on the decrease in profitability.
The following amount is included within cost of sales as loss on valuation of inventories.
Cost of sales: 69,199 thousand yen
A certain batch of TREAKISYM® 100mg was determined to be unsalable due to its poor quality,
which resulted in an inventory valuation loss.
(2) R&D costs included in general and administrative expenses:

2,266,556 thousand yen(Statement of changes in equity)(1) Type and number of shares issued and treasury shares
At beginning ofcurrent period
Commonstock

Increase(Unit: number of shares)
At end of
Decreasecurrent period

Shares outstanding

26,437,681

11,765,275－

38,202,956

Treasury shares

22,593

13,9006,350

30,143(Notes) 1. Increase of 11,765,275 shares issued in common stock is due to the exercise of share acquisition rights.
2. Increase of 13,900 treasury shares in common stock is due to the purchase of shares less than one unit.
3. Of the decrease of 6,350 treasury shares in common stock, 5,200 shares to the exercise of share acquisitionrights, and 1,150 shares to the sale of shares less than one unit.

(2) Number of shares to be issued upon exercise of share acquisition rights issued at the end of the fiscal
year under review
Common stock

465,900 shares(Note) Excludes share acquisition rights for which the commencement date of the exercise period has not yet arrived.

- 30 -(Tax effect accounting)Significant components of deferred tax assets and liabilities
Deferred tax assets:(Unit: thousands of yen)
Excess depreciation for lump-sum depreciable assets
1,903
Excess amortization for deferred assets
571,893
Research and development expenses disallowed
2,311,778
Accounts payable–other disallowed
1,653
Provision for retirement benefits disallowed
627Enterprise taxes payable disallowed
25,411
Asset retirement obligations disallowed
1,749
Share-based compensation expenses disallowed
128,054
Loss carried forward
4,935,118
Subtotal of deferred tax assets
7,978,186
Valuation allowances for loss carried forward(4,935,118)
Valuation allowances for deductible temporary differences(3,043,068)
Subtotal of valuation allowances(7,978,186)
Total deferred tax assets—- 31 -

(Financial instruments)(1) Financial instruments(i) Policies for financial instruments
The Company procures the funds necessary in light of the pipeline development plan (primarily by
third-party allotment and offering by new share issuance). A temporary surplus fund is invested infinancial instruments which are highly safe and liquid.
As a principle, the Company does not enter into derivative transactions for speculative trading
purposes but uses them within the scope prescribed in the Company’s internal rules.
(ii) Types of financial instruments and related risks
Operating receivables such as accounts receivable–trade and advances paid in connection with joint
development are exposed to the credit risk of customers and joint development partners. Operatingreceivables denominated in foreign currencies are exposed to foreign exchange fluctuation risk.
The Company intends to invest in marketable and investment securities which have a relatively low
risk of falling below initial investments, however, it might entail a finite risk.
Operating payables such as accounts payable–trade and accounts payable–other are mostly due
within 75 days. Operating payables denominated in foreign currencies are exposed to foreignexchange fluctuation risk.
The Company uses derivative transactions to avoid foreign exchange fluctuation risks and enters
into forward exchange contracts within the scope prescribed in the internal rules based on balances ofreceivables and payables denominated in foreign currencies as well as the actual volume of export andimport transactions denominated in foreign currencies.
Leasehold and guarantee deposits are mostly security deposits related to leased office premises andtheir refunds are subject to the credit risk of the lessor.
(iii) Risk management for financial instruments
1. Monitoring of credit risks (the risk that customers or counterparties may default on obligations)
In accordance with the Company’s internal credit policies for managing credit risk arising fromoperating receivables, the department in charge periodically monitors the creditworthiness of major
customers and monitors due dates and outstanding balances by individual customers. In addition, theCompany is making efforts to promptly identify and mitigate risks of bad debts from customers whoare having financial difficulties.
The Company enters into derivative transactions only with financial institutions which have asound credit profile in order to mitigate the counterparty risk.
2. Monitoring of market risk (the risk arising from fluctuations in foreign exchange rates, interest rates,and others)
The Company deposits cash primarily with financial institutions with high credit ratings.
For marketable and investment securities, the Company intends to avoid risks of falling below initialinvestments by investing in securities with a satisfactory credit rating and investment period in
accordance with the Company’s internal investment policies.

- 32 -

The Company enters into forward exchange contracts in order to avoid foreign exchange fluctuation
risks in connection with receivables and payables denominated in foreign currencies.
Followed by appropriate authorization procedures prescribed in the Company’s internal rules, theFinance & Accounting department executes and monitors derivative transactions. Monthly transaction
performances are reported to the Executive Management Committee.
3. Monitoring of liquidity risks (the risk that the Company may not be able to meet its obligations on
the scheduled due date)
Based on the report from each department, the responsible department of the Company preparesand updates its cash flow plans on a timely basis and ensures to maintain the liquidity on hand to
manage liquidity risk.
(iv) Supplementary explanation of the estimated fair value of financial instruments
The fair value of financial instruments is based on their quoted market price, if available. When
there is no quoted market price available, fair value is reasonably estimated. Since various
assumptions and factors are reflected in estimating the fair value, different assumptions and factors
could result in different fair value.
(v) Concentration of credit risk
As of the end of fiscal year under review, 100% operating receivables are from one particular major
customer.

- 33 -

(2) Fair value of financial instruments
The carrying value on the balance sheet, fair values, and their differences are as follows.
(Unit: thousands of yen)
Carrying value on the
Fair value
Difference
balance sheet(1) Cash and deposits
3,848,626
3,848,626—(2) Accounts receivable–trade406,988406,988—(3) Consumption taxes
314,761
314,761―
receivable
Assets, total
4,570,376
4,570,376—(1) Accounts payable–trade(2) Accounts payable–other(3) Income taxes payable
Liabilities, total

665,460
645,81381,9281,393,202

665,460
645,81381,9281,393,202————

Derivative transactions (*)

—

—

—

(*) Receivables and liabilities arising from derivative transactions are presented on a net basis and net liabilities are shownin parentheses.
(Note) 1. Fair value measurement of financial instruments and other matters related to securities and derivativetransactions
Assets(1)
Cash and deposits, (2) Accounts receivable–trade, and (3) Consumption taxes receivable
The carrying value is deemed as the fair value since these are scheduled to be settled in a short period oftime.
Liabilities(1)
Accounts payable–trade, (2) Accounts payable–other, and (3) Income taxes payable
The carrying value is deemed as the fair value since these are scheduled to be settled in a short period oftime.
Derivative transactions
Forward exchange contracts
The fair value of forward exchange contracts is measured based on market quotes obtained from financial
institutions.
(Note) 2. Financial instruments whose fair value is extremely difficult to determine
Leasehold and guarantee deposits (carrying value of 80,871 thousand yen) are not included in the above tablesince no market quote is available and their fair value is extremely difficult to determine.

- 34 -

(Note) 3. The redemption schedule for monetary assets and securities with maturities after the closing date

Due in one year or
less
Deposits
Accounts
receivable–trade
Consumption taxes
receivable
Total

3,848,535(Unit: thousands of yen)
Due after five years
Due after
through ten years
ten years——

Due after one year
through five years
—
—

—

—

314,761―――

4,570,285———

406,988(Transactions with affiliated parties)
Category

Name of Location

Capital orBusiness details or

Ratio of voting

Relationships

Transaction

Transaction

Account

Year-end

company

investment

profession

rights and otherwith affiliateddetailsamounttitlebalanceor person(thousands offorms ofpartiesyen)ownership(thousands of(thousands

yen)of yen)(Ownership)(%)
Executive Fuminori——

Exercise of

40,565share(37,250

and Chief Executive

acquisition

shares)

Officer of therightsYoshidaRepresentative(Ownership)

Director, President

Direct: 2.40

—

—

—

Company(Note) This information describes the exercise during the fiscal year under review of share acquisition rights granted
based on resolutions at Board of Directors meetings on March, 30, 2016.

(Per-share information)(1) Net assets per share(2) Net loss per share
Average number of shares outstanding during the year
(Significant subsequent events)
None to be reported.

- 35 -

105.76 yen(124.13) yen
32,950,201 sharesIndependent Auditor’s ReportFebruary 19, 2021
The Board of Directors
SymBio Pharmaceuticals Limited

Ernst & Young ShinNihon LLC
Tokyo, Japan

Hironao Yazaki
Designated Engagement Partner
Certified Public Accountant

Koichiro Kitaike
Designated Engagement Partner
Certified Public Accountant
OpinionPursuant to Article 436, Section 2, Paragraph 1 of the Companies Act, we have audited the accompanying
financial statements, which comprise the balance sheet, the statement of income, the statement of changes
in equity, the notes to non-consolidated financial statements and the related supplementary schedules of
SymBio Pharmaceuticals Limited (the “Company”) applicable to the 16th fiscal year from January 1, 2020
to December 31, 2020.
In our opinion, the accompanying financial statements present fairly, in all material respects, the financial
position and results of operations of the Company applicable to the fiscal year ended December 31, 2020,in accordance with accounting principles generally accepted in Japan.
Basis for Opinion
We conducted our audit in accordance with auditing standards generally accepted in Japan. Our
responsibilities under those standards are further described in the Auditor’s Responsibilities for the Audit of
the Financial Statements section of our report. We are independent of the Company in accordance with the
ethical requirements that are relevant to our audit of the financial statements in Japan, and we have fulfilled
our other ethical responsibilities in accordance with these requirements. We believe that the audit evidence
we have obtained is sufficient and appropriate to provide a basis for our opinion.

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Responsibilities of Management, the Corporate Auditor and the Board of Corporate Auditors for the
Financial Statements
Management is responsible for the preparation and fair presentation of these financial statements inaccordance with accounting principles generally accepted in Japan, and for such internal control as
management determines is necessary to enable the preparation of financial statements that are free frommaterial misstatement, whether due to fraud or error.
In preparing the financial statements, management is responsible for assessing the Company’s ability tocontinue as a going concern and disclosing, as required by accounting principles generally accepted in Japan,
matters related to going concern.
The Corporate Auditor and the Board of Corporate Auditors are responsible for overseeing the Company’s
financial reporting process.
Auditor’s Responsibility for the Audit of the Financial Statements
Our objectives are to obtain reasonable assurance about whether the financial statements as a whole are freefrom material misstatement, whether due to fraud or error, and to issue an auditor’s report that includes ouropinion. Misstatements can arise from fraud or error and are considered material if, individually or in theaggregate, they could reasonably be expected to influence the economic decisions of users taken on the basisof the financial statements.
As part of an audit in accordance with auditing standards generally accepted in Japan, we exercise
professional judgment and maintain professional skepticism throughout the audit. We also:・ Identify and assess the risks of material misstatement of the financial statements, whether due to fraud
or error, design and perform audit procedures responsive to those risks, and obtain audit evidence thatis sufficient and appropriate to provide a basis for our opinion.
・ Consider internal control relevant to the audit in order to design audit procedures that are appropriate in
the circumstances for our risk assessments, while the purpose of the audit of the financial statements is
not expressing an opinion on the effectiveness of the Company’s internal control.
・ Evaluate the appropriateness of accounting policies used and the reasonableness of accounting estimatesand related disclosures made by management.
・ Conclude on the appropriateness of management’s use of the going concern basis of accounting and,based on the audit evidence obtained, whether a material uncertainty exists related to events orconditions that may cast significant doubt on the Company’s ability to continue as a going concern. If
we conclude that a material uncertainty exists, we are required to draw attention in our auditor’s reportto the related disclosures in the financial statements or, if such disclosures are inadequate, to modify our
opinion. Our conclusions are based on the audit evidence obtained up to the date of our auditor’s report.
However, future events or conditions may cause the Company to cease to continue as a going concern.
・ Evaluate the overall presentation, structure and content of the financial statements, including thedisclosures, and whether the financial statements represent the underlying transactions and events in amanner that achieves fair presentation in accordance with accounting principles generally accepted in- 37 -

Japan.
We communicate with the Corporate Auditor and the Board of Corporate Auditors regarding, among othermatters, the planned scope and timing of the audit and significant audit findings, including any significant
deficiencies in internal control that we identify during our audit.
We also provide the Corporate Auditor and the Board of Corporate Auditors with a statement that we havecomplied with the ethical requirements regarding independence that are relevant to our audit of the financial
statements in Japan, and to communicate with them all relationships and other matters that may reasonably
be thought to bear on our independence, and where applicable, related safeguards.
Interest Required to Be Disclosed by the Certified Public Accountants Act of Japan
Our firm and its designated engagement partners do not have any interest in the Company which is required
to be disclosed pursuant to the provisions of the Certified Public Accountants Act of Japan.

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Report of the Audit & Supervisory Board
We, Audit & Supervisory Board Members, prepare this report of audit with regard to the execution of
Directors’ duties during the 16th Term of the Company from January 1, 2020 to December 31, 2020, as theunanimous opinion of all the Audit & Supervisory Board Members after careful discussion based on theaudit reports prepared by respective Audit & Supervisory Board Members, and report as follows.
1. Method and Contents of the Audit by the Audit & Supervisory Board Members and the Audit &Supervisory Board
The Audit & Supervisory Board formulated the audit policy and plan for the Term reported, and received
reports from the respective Audit & Supervisory Board Members with regard to the state of implementation
and results of audits as well as received the reporting from Directors and the accounting auditor with regard
to the state of execution of their duties, and requested additional explanations as deemed necessary.
The respective Audit & Supervisory Board Members, in conformity with the standards for audits by Audit& Supervisory Board Members that the Audit & Supervisory Board set forth and in accordance with theaudit policy and plan for the Term, strove to collect information and improve audit environments bycommunicating with Directors, the internal audit section, and other employees. We also attended Board of
Directors meetings and other important meetings, received the reporting from Directors and employees withregard to the state of execution of their duties, requesting additional explanations as deemed necessary,
reviewed documents for important settlements, and researched the situation of operations and assets.
Moreover, with regard to the system to ensure that the execution of Directors’ duties described in thebusiness report was compliant with laws and ordinances and the Company’s Articles of Incorporation andother systems required to secure the appropriateness of operations as a stock company maintained based on
the contents of resolution by the Board of Directors with regard to the maintenance of systems stipulated by
the Ordinance for Enforcement of Article 100, Paragraph 1 and 3 of the Companies Act (hereinafter the“Internal Control System”), we received reporting on the status of their establishment and operation from
Directors and employees, requested additional explanation as deemed necessary, and expressed our opinion.
Based on the method described above, we reviewed the business report and supplementary schedules withregard to the Term reported.
In addition, we monitored and inspected the independent position of the accounting auditor and theexecution of appropriate audits by the accounting auditor, and also received the reporting from theaccounting auditor with regard to the state of execution of its duties, requesting additional explanation as
deemed necessary. Furthermore, we received the notification from the accounting auditor that “the system
to ensure that its duties are executed as appropriate (the items listed by the respective paragraphs of Article
131 of the Ordinance on the Accounting of Companies)” is maintained in accordance with “the standards
for quality control of audits (Business Accounting Council, October 28, 2005),” requesting additional
explanation as deemed necessary. Based on the method described above, we reviewed the financial report(including balance sheet, statement of income, statement of changes in equity, and notes to non-consolidated
financial statements) and related supplementary schedules for the Term reported.

- 39 -

2. Results of audit(1) Results of the audit of the business reporta. The business report and supplementary schedules fairly present the Company’s situation in accordancewith laws and ordinances and the Company’s Articles of Incorporation.
b. No misconduct in the execution of Directors’ duties or any material facts in violation of laws orordinances or the Company’s Articles of Incorporation was observed.
c. The contents of resolution by the Board of Directors with regard to the Internal Control System areappropriate. Also, there is no matter to be noted as for the descriptions in the business report regarding
such Internal Control System and the execution of Directors’ duties.
(2) Results of the audit of the financial statements and related supplementary schedules
Both the method used for and the result of the audit conducted by the accounting auditor, Ernst &Young ShinNihon LLC, are appropriate.
February 19, 2021
Audit & Supervisory Board,
SymBio Pharmaceuticals Limited______________________________
Kiyoshi Watanabe
Full-time Audit & Supervisory Board Member (Outside)______________________________
Kesao Endo
Audit & Supervisory Board Member (Outside)______________________________
Eiji Ebinuma
Audit & Supervisory Board Member (Outside)

End of Report

End of Document- 40 -