Summary of Financial Statements
for the First Nine Months of Fiscal Year Ending December 31, 2020
[Japanese GAAP] (Non-consolidated)
November 10, 2020
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 and Chief Financial Officer Takaaki Fukushima

Scheduled Date to File Quarterly November 11, 2020
ReportTEL +81-3-5472-1125—

Date of Dividend
Payment (plan)

Supplementary materials for the quarterly financial statements:

Yes ・ No

Holding of quarterly earnings performance review:

Yes ・ No

(Amounts of less than one million yen are rounded down.)
1. Business Results for the First Nine Months of FY 2020 (January 1, 2020 to September 30, 2020)(1) Operating Results (cumulative)(Percentages indicate year-on-year changes.)
Net Sales
Q3 FY 2020
Q3 FY 2019

Operating Profit (Loss)

Ordinary Profit (Loss)

Profit (Loss)

Millions of yen%

Millions of yen%

Millions of yen%

Millions of yen

%

2,332
2,008

16.2
(33.8)(3,142)(3,536)——(3,220)(3,641)——(2,694)(3,640)——Earnings (Loss) per Share Diluted Earnings per Share
Yen

Yen

Q3 FY 2020
(84.59)—Q3 FY 2019(161.33)—(Note 1) On July 1, 2019, the Company conducted a 1-for-4 consolidation of common stock. Earnings per share have been
calculated based on the assumption that this consolidation was conducted at the beginning of FY 2018.
(Note 2) Diluted earnings per share is not stated above due to recording of a net loss per share, despite the potential dilution ofshares.
(2) Financial Position
Total Assets
Q3 FY 2020 (as of September 30, 2020)
FY 2019 (as of December 31, 2019)(Reference) Shareholders’ equity:

Net Assets

Equity Ratio

Millions of yen

Millions of yen

%

6,232
5,273

4,995
4,400

70.6
71.7

Q3 FY 2020 (as of September 30, 2020)
FY 2019 (as of December 31, 2019)―1―

4,397 million yen
3,779 million yen

2. Dividends
Annual Dividend per Share
1st QuarterYen

2nd Quarter
Yen

3rd Quarter
Yen

Fiscal Year End
Yen

Full Year

FY 2019—
0.00
FY 2020—
0.00
FY 2020 (Forecast)(Note) Revision of dividend forecasts recently announced:

—
—

0.00

0.00

0.00

0.00

Yen

Yes ・ No

3. Earnings Forecasts for FY 2020 (January 1, 2020 to December 31, 2020)(Percentages indicate year-on-year changes.)
Operating Profit(Loss)Net Sales
Millions of yen% Millions of yen

Full Year
3,043
7.2(4,592)(Note) Revision of earnings forecasts recently announced:

Ordinary Profit(Loss)

Earnings (Loss) per
Share

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

%

Yen

—

—

—

(116.13)(4,656)
Yes ・ No

(3,796)

Notes:(1) Application of special accounting treatment in preparation of quarterly financial reports: 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 year (including treasury shares)(ii) Total number of treasury shares at the endof the year

Q3 FY 2020

35,198,331 shares

FY 2019

26,437,681 shares

Q3 FY 2020

26,543 shares

FY 2019

22,593 shares(iii) Average number of shares during the year
Q3 FY 2020
31,850,674 shares
Q3 FY 2019 22,565,488 shares(cumulative)(Note) On July 1, 2019, the Company conducted a 1-for-4 consolidation of common stock. Total number of issued shares at the endof the year, total number of treasury shares at the end of the year, and average number of shares during the year have been
calculated based on the assumption that this consolidation was conducted at the beginning of FY 2018.
* Summary of the quarterly financial statements is not subject to quarterly reviews by certified public accountants or accounting
corporations.
* Explanation regarding the appropriate use of earnings forecasts and other matters
All forecasts presented in this document, including earnings forecasts, are based on the information currently available to theCompany and assumptions 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.
Qualitative Information on Quarterly Financial Results (3) Explanation of earnings forecasts and other forward-looking
information” on Page 5 of the attachment.

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Index of the attachment
1. Qualitative Information on Quarterly Financial Results ........................................................................................................................ 2(1) Business results ................................................................................................................................................................................ 2(2) Financial position ............................................................................................................................................................................. 5(3) Earnings forecasts and other forward-looking information .............................................................................................................. 6
2. Quarterly Financial Statements and Primary Notes ............................................................................................................................... 7(1) Quarterly balance sheet .................................................................................................................................................................... 7(2) Quarterly statement of income ......................................................................................................................................................... 9(3) Notes to quarterly financial statements .......................................................................................................................................... 10(Notes to going concern assumptions) ............................................................................................................................................. 10(Relating to the quarterly statement of income) ............................................................................................................................... 10(In case of significant changes to shareholders’ equity) ................................................................................................................... 10(Significant subsequent events) ....................................................................................................................................................... 10―1―

1. Qualitative Information on Quarterly Financial Results(1) Business results
Progress in the Company’s business for the first nine months of the fiscal year under review is as follows.
(i) Domestic business[Establishment of the Company’s own sales force]
SymBio plans to transition to its own sales organization for the sale of TREAKISYM® from January 2021 as its business
partnership agreement with Eisai Co., Ltd. (“Eisai”) expires in December 2020. Through this transition, the Company aims toachieve profitability in FY 2021 and sustainable growth thereafter.
In the third quarter of the fiscal year under review, the Company began transferring sales operations from Eisai as part ofestablishing its own sales structure. As planned, the Company assigned 51 medical representatives across Japan and six regional
hematology experts to understand the needs of each region and develop plans tailored to address those needs. Through these
efforts, the Company expects to enhance the productivity of its sales force.
On September 7, 2020, the Company concluded distribution agreements with Suzuken Co., Ltd. (“Suzuken Group”) and Toho
Pharmaceutical Co., Ltd. (consolidated subsidiary of Toho Holdings Co., Ltd.; “Kyoso Mirai Group”) to establish nationwide
product distribution coverage. After the business partnership with Eisai ends, the Suzuken Group and Kyoso Mirai Group willserve as the Company’s wholesalers. The Company will also collaborate with S.D. Collabo Co., Ltd. to establish two logistics
centers, one in Eastern and one in Western Japan. With its own sales organization in place, the Company is on track to achieve
profitability in FY 2021.
[Stable supply]
SymBio currently imports lyophilized injectable formulation of TREAKISYM® from Astellas Deutschland GmbH (“Astellas
Deutschland”), a subsidiary of Astellas Pharma Inc., and markets the product in Japan through Eisai. In the third quarter of the
fiscal year under review, the Company conducted secondary packaging and quality tests for several imported batches and shipped
them to Eisai in accordance with Company plans. The inventory level of TREAKISYM®, which was at a significantly low levelin the first half of the fiscal year compared to that a year ago, has stabilized and the Company will continue to work with Astellas
Deutschland to maintain a stable supply of the product.
[Anticancer agents: SyB L-0501 (lyophilized powder formulation), SyB L-1701 (ready-to-dilute (“RTD”) formulation), SyB
L-1702 (rapid infusion (“RI”) formulation) (generic name: bendamustine hydrochloride; trade name: TREAKISYM®)]
TREAKISYM® is used to treat a wide array of malignant lymphoma. SymBio obtained manufacturing and marketing approvalfor TREAKISYM® for the indications of first-line treatment of low-grade non-Hodgkin’s lymphoma (low-grade NHL) (Note 1) andmantle cell lymphoma (MCL) in December 2016, recurrent/refractory low-grade NHL and MCL in October 2010, and chronic
lymphocytic leukemia (CLL) in August 2016. Further, the combination therapy of TREAKISYM® and rituximab (BR therapy)
was added to the Guidelines for Tumors of Hematopoietic and Lymphoid Tissues published by the Japanese Society of
Hematology in July 2018, and became a standard treatment option for all previously approved indications. With thisdevelopment, TREAKISYM® established its foothold as the standard treatment for malignant lymphoma.
In July 2018, the Company obtained approval to partially revise the manufacturing and marketing authorization for
TREAKISYM®, allowing the product to be used in combination with not only rituximab but also other new anti-CD20 antibodies
for the treatment of CD-20 positive follicular lymphoma (FL), a typical histologic type of low-grade NHL. Subsequent to thisapproval, TREAKISYM® is offered to patients as a new treatment option in combination with obinutuzumab (Note 2). In March
2019, the Company obtained approval of a partial change to allow the use of TREAKISYM® as a pretreatment agent for tumorspecific T-cell infusion therapy,(Note 3) allowing TREAKISYM® to be used as a pretreatment agent for Kymriah® intravenous
infusion (Note 4), the first chimeric antigen receptor T-cell (CAR-T) therapy (Note 5) to be approved in Japan. Due to its expanding
use as a pretreatment agent for regenerative medicine and other pharmaceutical products, TREAKISYM® has further solidified
its position as a standard treatment for malignant lymphoma.
SymBio conducted a Phase III clinical trial of BR therapy targeting recurrent/refractory diffuse large B-cell lymphoma (r/r
DLBCL), an additional indication of the combination therapy following the already-approved indications. After obtaining
favorable results from the trial, with the overall response rate (the primary endpoint of the trial) exceeding expected levels, theCompany applied for a partial change to its marketing authorization in May 2020. Further, the Company is conducting a followup study with overall survival as the primary endpoint, since survival data (e.g., overall survival and progression-free survival)
for TREAKISYM® administered in combination with rituximab is crucial in establishing the product as a DLBCL treatment. In―2―

June 2020, Chugai Pharmaceutical Co., Ltd. (“Chugai Pharmaceutical”) filed for manufacturing and marketing approval forpolatuzumab vedotin (Note 6) used in combination with BR therapy targeting r/r DLBCL. In response, in July 2020 the Company
applied for approval to partially amend its marketing authorization for TREAKISYM® used in combination with polatuzumab
vedotin and rituximab. Once polatuzumab vedotin is included in the NHI drug price list after the Company and Chugai
Pharmaceutical obtain approval, TREAKISYM® can be used in the combination therapy of polatuzumab vedotin and BR therapy.
Because there is currently no effective treatment for r/r DLBCL, the newly added indication for TREAKISYM®, combination
therapies comprising multiple anticancer drugs are used as rescue chemotherapy. However, because these therapies often cause
serious adverse effects, patients are in dire need the development of highly effective and safe drugs. BR therapy is already used totreat patients with r/r DLBCL in Europe and the U.S. In Japan, patient organizations and relevant academic societies haverequested the Ministry of Health, Labour and Welfare to make BR therapy available as soon as possible. Once approval is
granted, the Company expects TREAKISYM® to be widely available as a treatment option for patients.
In September 2017, SymBio concluded a license agreement with Eagle Pharmaceuticals, Inc. (head office: New Jersey, U.S.)
and obtained exclusive rights to develop and market TREAKISYM® liquid formulation (RTD and RI liquid formulations) (Note 7)in Japan. The Company obtained manufacturing and marketing approval for the RTD liquid formation on September 18, 2020,and plans to launch the product in January 2021. For the RI liquid formulation, the Company commenced a clinical trial with themain goal of confirming safety in November 2018, successfully enrolled the target number of patients, and completed follow-up
observation, i.e., reached last-patient-last-visit (LPLV), in September 2020. The Company plans to promptly file for approval
once the trial is concluded and expects to obtain approval in the second half of 2022. The RI liquid formulation significantly
reduces the infusion time to 10 minutes, down from the 60 minutes required by the currently available lyophilized powder and
RTD formulations. This will greatly reduce burden on patients and healthcare providers, enabling the Company to provide
substantial value-added. Further, with exclusive rights to manufacture these liquid formulations, which are patent-protected, theCompany is able to extend the life of these products until 2031 and further strengthen the foundation of its business growth.
(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 ofJapanese 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 and destroy 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 specificallyrecognize cancer cells) taken from cancer patients are artificially bestowed with cancer 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
recurrent/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 intracellular domains of T-cell receptors with the antigen
binding sites of antibodies capable of recognizing 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 patients with 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 promising target in new drug development. Polatuzumab vedotin selectively binds to CD79b
while minimally affecting normal cells, and destroys B-cells with the chemotherapeutic agent it contains.

―3―

(Note 7)

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

[Anticancer agents: SyB L-1101 (intravenous formulation) and SyB C-1101 (oral formulation) (generic name: rigosertib
sodium)]U.S. licensor Onconova Therapeutics, Inc. (head office: Pennsylvania, U.S., “Onconova”) conducted 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, with overall survival as
the primary endpoint. In August 2020, Onconova announced that the primary endpoint—improved survival compared tophysician’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 the genomic 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 the investigational drug (incombination with azacitidine (Note 8)) in the U.S. in first-line HR-MDS patients, and the results suggested that the oral formulationof rigosertib and azacitidine used in combination were safe and effective. In June 2017, the Company initiated a Phase I clinical
trial to confirm the safety and tolerability of the single high-dose oral formulation of rigosertib as first-line treatment for HRMDS in Japanese patients, and completed patient enrollment in June 2019.
(Note 8)

Azacitidine (Vidaza®, marketed by Nippon Shinyaku Co., Ltd.): This hypomethylating agent (for injection) wasapproved 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 inhematopoietic stem cell transplantation. MDS is a preleukemic state, and decrease in tumor suppressor gene due toexcessive methylation of DNA is thought to be related to the disease. Hypomethylating agents such as azacitidine arethought to suppress progress to leukemia by restoring tumor suppressor gene with a deterrent effect against
methylation of DNA.

[Antiviral drug: SyB V-1901 (generic name: brincidofovir)]
On September 30, 2019, the Company concluded an exclusive global licensing agreement for intravenous and oral formulationof 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, the Company decided to prioritize
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 the efficacy and safety data of BCV obtained from clinical trials, the Company intends to investigate the efficacy ofthe drug against a range of dsDNA viral infections and expand target indications to include multiple viral infections occurring
after hematopoietic stem cell transplantation. It also intends to pursue the possibility of expanding target indications of the drug
to viral 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 diligently preparing to initiate clinical trials to determine theappropriate dose of BCV IV for pediatric use scheduled for 2021.
BCV Oral demonstrated highly active antiviral effects in clinical trials conducted by Chimerix in Europe and the U.S. These
trials also confirmed that BCV Oral had broad-spectrum antiviral effects. Based on these extensive antiviral effects of BCV Oralagainst various dsDNA viruses (Note 10), the Company expects BCV IV to also be effective and safe in the treatment andprevention of various viral infections occurring after hematopoietic stem cell transplantation.
(Note 9)

Brincidofovir (BCV) has a structure in which cidofovir (an antiviral drug already approved and marketed 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 ismetabolized 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 thecompound’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.

―4―

(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 U.S.) in October 2015—under the rules of theInternational Chamber of Commerce, seeking damages of 82 million US dollars arising from MDCO’s decision to discontinue
and withdraw IONSYS from the 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 theCompany’s claim that MDCO failed to provide adequate assurances of performance under the license agreement and denied theCompany’s claim for damages. However, the arbitral tribunal awarded the Company 4,950,000 US dollars representing 50% of
its legal fees and expenses 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 L-0501 in these countries werein 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 the antiviral drug brincidofovir inlicensed in September 2019 for the time being. However, the Company will continue its existing initiatives of reviewing multiple
licensing projects, searching and evaluating new drug candidates for potential in-licensing. Through these efforts, the Company
aims to create long-term business value as a profitable biopharmaceutical company with growth potential.
(iv) Business results
Net sales totaled 2,332,601 thousand yen for the first nine months of the FY 2020, primarily reflecting product sales of
TREAKISYM®, and overall net sales increased 16.2% year on year.
Selling, general and administrative expenses totaled 3,753,157 thousand yen (-8.4% year on year), including research anddevelopment (“R&D”) expenses of 1,754,364 thousand yen (-11.0% year on year) primarily due to expenses associated withclinical trials for the intravenous formulation of TREAKISYM® and the intravenous formulations of rigosertib, as well as otherselling, general and administrative expenses of 1,998,792 thousand yen (-6.0% year on year), including upfront spending toestablish an internal sales structure.
As a result, an operating loss of 3,142,396 thousand yen was recognized in the first nine months of FY 2020 (versus an
operating loss of 3,536,352 thousand yen in the same period of FY 2019). Due to non-operating expenses of 81,103 thousand
yen, primarily comprising foreign exchange losses of 55,648 thousand yen and share issuance cost of 23,203 thousand yen,ordinary loss totaled 3,220,921 thousand yen (versus an ordinary loss of 3,641,904 thousand yen in the same period of FY 2019).
Despite posting 525,145 thousand yen in settlement received, the bottom-line loss in the first nine months of the FY 2020 totaled
2,694,284 thousand yen (versus a loss of 3,640,556 thousand yen in the same period of FY 2019).
Segment information has been omitted since the Company operates within a single segment, which includes the research anddevelopment, manufacturing, and marketing of pharmaceutical drugs and other related activities.

(2) Financial position
Total assets as of September 30, 2020 stood at 6,232,069 thousand yen, an increase of 958,114 thousand yen from the previous
fiscal year end. This was primarily due to increases of 816,692 thousand yen in cash and deposits, 360,803 thousand yen inmerchandise and finished goods, 163,142 thousand yen in software, 17,227 thousand yen in tools, furniture and fixture, 13,012
thousand yen in prepaid expenses, and 10,275 thousand yen in lease and guarantee deposits, offsetting decreases of 296,167
thousand yen in accounts receivable–trade, 94,791 thousand yen in software in progress, 79,114 thousand yen in consumption
taxes receivable, 41,791 thousand yen in advances paid, and 17,248 thousand yen in construction in progress .
Total liabilities stood at 1,236,495 thousand yen, an increase of 362,656 thousand yen from the previous fiscal year end, owing
mainly to increases of 394,286 thousand yen in accounts payable–other and 20,583 thousand yen in accounts payable–trade,
offsetting a decrease of 55,541 thousand yen in income taxes payable.

―5―Under net assets, decreases of 23,082 thousand yen in share acquisition rights and 2,694,284 thousand yen in retained earnings
due to the recording of a bottom-line loss were offset by increases of 1,658,022 thousand yen in capital surplus and 1,655,936
thousand yen in share capital. As a result, total net assets increased by 595,458 thousand yen from the previous fiscal year end to4,995,574 thousand yen.
The equity ratio consequently declined 1.1 percentage points from the previous fiscal year end to 70.6%.

(3) Earnings forecasts and other forward-looking information
As of the date of this document, no revision was made to the earnings forecasts for FY 2020 revised on September 17, 2020.

―6―

2. Quarterly Financial Statements and Primary Notes(1) Quarterly balance sheet(Unit: thousands of yen)
FY 2019(as of December 31, 2019)

Q3 FY 2020(as of September 30, 2020)

3,910,830
549,275—
94,002
41,791
275,324
16,267
4,887,491

4,727,522
253,107360,803
107,014—
196,210
124,884
5,769,542

34,734
19,242
21,51375,49132,19336,4704,265
72,92994,974
145,551
240,525

258,116
50,759308,876070,44670,446
386,463
5,273,955

080,72280,722
462,527
6,232,069

120,913639,482
87,75624,066872,219

141,496
1,033,769
32,21427,081
1,234,562

1,619
1,619
873,838

1,933
1,933
1,236,495

AssetsCurrent assets
Cash and deposits
Accounts receivable–trade
Merchandise and finished goods
Prepaid expenses
Advances paid
Consumption taxes receivable
Other
Total current assets
Non-current assets
Property, plant and equipment
Buildings, net
Tools, furniture and fixtures, net
Construction in progress
Total property, plant and equipment
Intangible assets
Software
Software in progress
Total intangible assets
Investments and other assets
Shares of subsidiaries
Leasehold and guarantee deposits
Total investments and other assets
Total non-current assets
Total assets
Liabilities
Current liabilities
Accounts payable–trade
Accounts payable–other
Income taxes payable
Other
Total current liabilities
Non-current liabilities
Provision for retirement benefits
Total non-current liabilities
Total liabilities―7―

(Unit: thousands of yen)
FY 2019(as of December 31, 2019)

Q3 FY 2020(as of September 30, 2020)

14,870,639
14,843,137(25,919,496)(15,077)3,779,202
620,9134,400,116
5,273,955

16,526,575
16,501,160(28,613,781)(16,210)
4,397,744
597,830
4,995,574
6,232,069

Net assets
Shareholders’ equity
Share capital
Capital surplus
Retained earnings
Treasury shares
Total shareholders’ equity
Share acquisition rights
Total net assets
Total liabilities and net assets―8―(2) Quarterly statement of income(For the first nine months of FY 2020)

Net sales
Cost of sales
Gross profit
Selling, general and administrative expenses
Operating profit (loss)
Non-operating income
Interest income
Interest on tax refund
Dividend income of insurance
Insurance claim income
Other
Total non-operating income
Non-operating expenses
Commission expenses
Share issuance costs
Foreign exchange losses
Other
Total non-operating expenses
Ordinary profit (loss)
Gain on reversal of share acquisition rights
Settlement received
Total extraordinary income
Profit (loss) before income taxes
Income taxes–current
Total income taxes
Profit (loss)

Q3 FY 2019(from January 1, 2019
to September 30, 2019)
2,008,048*1,445,149
562,899
4,099,251(3,536,352)(Unit: thousands of yen)
Q3 FY 2020
(from January 1, 2020
to September 30, 2020)
2,332,601*1,721,840
610,760
3,753,157(3,142,396)

201
76
1,282
2,736
0
4,297

130
120
2,324
—
2
2,578

7,904
9,440
92,277
227
109,850(3,641,904)
4,197
—
4,197
(3,637,706)
2,850
2,850
(3,640,556)—
23,20355,6482,251
81,103(3,220,921)
4,341
525,145
529,486(2,691,434)
2,850
2,850
(2,694,284)―9―

(3) Notes to quarterly financial statements(Notes to going concern assumptions)None to be reported.
(Relating to the quarterly statement of income)*The value of ending inventory is the amount after inventory write-downs in connection with a decline in profitability, and thefollowing loss on valuation of inventories is included in the cost of sales.
(Unit: thousands of yen)

Q3 FY 2019(from January 1, 2019
to September 30, 2019)
187,840

Q3 FY 2020
(from January 1, 2020
to September 30, 2020)
68,838The above figures reflect the booking of a loss on valuation of inventories, as the Company determined that some batches of
TREAKISYM® 100mg vials were unfit for sales due to quality defects.
(In case of significant changes to shareholders’ equity)
In the first nine months of FY 2020, the Company issued new shares due to the exercise of some of share acquisition rights
pertaining to the 33rd, 36th, 37th, 38th, 40th, 41st, 47th, and 50th warrants. As a result, share capital and capital surplus each increased
by 1,655,936 thousand yen. The total value of treasury shares increased 4,917 thousand yen as a result of a share repurchase.
Further, the Company disposed of treasury shares due to the exercise of some of share acquisition rights issued in the 33rd, 36th,and 38th warrants. As a result, the total value of treasury shares fell 3,259 thousand yen and other capital surplus increased 2,176
thousand yen.
The disposal of treasury shares in response to the request to sell shares by shareholders of less-than-one unit of shares led to
declines of 525 thousand yen in the total value of treasury shares and 91 thousand yen in other capital surplus.
As a result, as of September 30, 2020 share capital was 16,526,575 thousand yen, capital surplus 16,501,160 thousand yen, andthe total value of treasury shares 16,210 thousand yen.
(Significant subsequent events)
None to be reported.

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