Summary of Financial Results
for the Third Quarter of Fiscal Year Ending December 31, 2018
[Japanese GAAP] (Non-consolidated)
November 9, 2018
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, Head of Corporate Planningand Administration, Chief Financial Officer

Kenji Murata

TEL +81-3-5472-1125

Scheduled Date to File
Quarterly Report

November 12, 2018

Date of Dividend
Payment (plan)－

Supplementary materials for quarterly financial results:

Yes

No

Holding of quarterly earnings performance review:

Yes

No

(Millions of yen – rounded down, unless otherwise stated)

1. Business Results for the First Nine Months of FY 2018 (cumulative) (January 1, 2018 to September 30, 2018)(1) Operating Results (cumulative)(Percentages indicate year-on-year changes)

Operating Income(Loss)Net Sales

Ordinary Income(Loss)

Quarterly Net Income(Loss)

Millions of yen%

Millions of yen%

Millions of yen%

Millions of yen

%

3,032
2,416

25.5
71.7

(1,907)(3,508)－－(1,937)(3,546)－－(1,940)(3,546)－－Q3 FY 2018
Q3 FY 2017

Quarterly Net Income(Loss) per Share

Diluted Quarterly Net
Income per ShareYen
Yen
Q3 FY 2018(31.31)－Q3 FY 2017(72.64)－(Note) Diluted quarterly net income per share is not stated above due to quarterly net loss per share, despite the potential dilutionof shares.
(2) Financial Position

Q3 FY 2018 (as of September 30, 2018)
FY 2017 (as of December 31, 2017)

Total Assets

Net Assets

Millions of yen
5,466
4,252

Millions of yen
4,645
3,239

(Reference) Shareholders’ equity: Q3 FY 2018 (as of September 30, 2018)
FY 2017 (as of December 31, 2017)

Equity Ratio
%
73.9
63.6
4,041 million yen
2,702 million yen

2. Dividends

FY 2017
FY 2018
FY 2018 (Forecast)

1st Quarter
Yen－－

Annual Dividend per Share
2nd Quarter
3rd Quarter
Fiscal Year End
Yen
Yen
Yen
0.00
－
0.00
0.00
－
0.00

(Note) Revision of dividend forecasts recently announced:

Yes ・ No

Full Year
Yen
0.00
0.00

3. Earnings Forecasts for FY 2018 (January 1, 2018 to December 31, 2018)(Percentages indicate year-on-year changes)

Operating
Income (Loss)

Net Sales
Millions of yen

Full Year

4,201% Millions of yen

22.0(2,981)

Ordinary
Income (Loss)Net Income (Loss)Net Income (Loss)
per Share% Millions of yen% Millions of yen

%

Yen

－

－

－

(46.53)(3,044)(3,056)

Yes ・ No

(Note) Revision of earnings forecasts recently announced:

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 revisionof accounting standards:(b) Changes in accounting policies due to otherreasons:

Yes ・ NoYes ・ No(c) Changes in accounting estimates:

Yes ・ No(d) Restatements after error corrections:

Yes ・ No

(3) Number of shares outstanding (common stock)(i) Number of shares outstanding at the end of
the period (including treasury stock)(ii) Number of shares of treasury stock at theend of the period(iii) Average number of shares during the period(cumulative)

Q3 FY 201876,662,224 shares

FY 201754,049,224 shares

Q3 FY 201875 shares

FY 201775 shares

Q3 FY 2018

61,994,152 shares

Q3 FY 2017

48,814,135 shares*

The quarterly financial results are not subject to quarterly reviews by certified public accountants or an accounting auditor.

*

Explanation regarding the appropriate use of earnings forecasts and other matters
All forecasts presented in this document, including the outlook on earnings, are based on the information currently available tomanagement and assumptions judged to be reasonable. Actual results may differ substantially from these forecasts due tovarious factors. Regarding the assumptions on which the Company’s earnings forecasts are based and their usage, please refer
to “1. Qualitative Information Concerning Quarterly Financial Results, (3) Qualitative information concerning earnings
forecasts,” on Page 4 of the attachment.

Index of the attachment
1. Qualitative Information Concerning Quarterly Financial Results …………………………………………………….……..

1(1) Qualitative information concerning business results ……………………………………………………………………..

1(2) Qualitative information concerning financial position …………………………………………….……………………..

4(3) Qualitative information concerning earnings forecasts …………………………………………………………………..

4

2. Quarterly Financial Statements and Primary Notes ………………………………………………………………………….

5(1) Quarterly balance sheets ………………………………………………………………………….………………………

5(2) Quarterly statements of income (cumulative) …………………………………………………………………………

7(3) Notes on quarterly financial statements

8(Notes regarding going concern assumption) ……………………………………………………………………………..

8(Notes regarding significant changes in shareholders’ equity) ………………………………….………………………...

8(Significant subsequent events) ……………………………………………………………..……………….………….…

8

1. Qualitative Information Concerning Quarterly Financial Results(1) Qualitative information concerning business results
Progress in the Company’s business for the first nine months of FY2018 is as follows:(i) Domestic[Anticancer agent: SyB L-0501 (lyophilized powder formulation), SyB L-1701 (ready-to-dilute (“RTD”)
formulation), SyB L-1702 (rapid infusion (“RI”) formulation) and SyB C-0501 (oral formulation) (genericname: bendamustine hydrochloride, trade name: TREAKISYM®)]
The Company markets TREAKISYM® in Japan through its business partner, Eisai Co., Ltd. (“Eisai”).
The Company obtained marketing approvals for first-line treatment of low-grade non-Hodgkin’s
lymphoma (low-grade NHL) and mantle cell lymphoma (MCL) in December 2016, and for chronic
lymphocytic leukemia (CLL) in August 2016. These are in addition to the approval for the indication ofrecurrent/refractory low-grade NHL and MCL which was obtained in October 2010. Following thisindication expansion, TREAKISYM® is steadily increasing its market share in the area of first-line
treatment by replacing R-CHOP, the conventional standard treatment, at medical clinics and hospitals.
Further, the combination treatment (BR therapy) of TREAKISYM® and rituximab was newly included in
the Guidelines for Tumors of Hematopoietic and Lymphoid Tissues 2018 edited and published by theJapanese Society of Hematology in July 2018, with TREAKISYM® effectively establishing its foothold as
the standard treatment for malignant lymphoma. In-market sales for the first nine months of the fiscal year
ending December 31, 2018 posted a robust 15.2% increase year-on-year (NHI price basis). Net sales toEisai are progressing as planned.
In addition to the three already-approved indications, the Company has started a Phase III clinical trial
for recurrent/refractory diffuse large B-cell lymphoma (r/r DLBCL) and is currently working on patient
enrollment towards obtaining approval. The trial is in response to serious need at clinics and hospitals as
there is currently no reliable standard treatment. Patient groups have petitioned to the regulatory authorities
for the approval of BR therapy. With a view to providing new therapeutic alternatives and maximizing
product value, the Company began the Phase III clinical trial in August 2017 and is diligently working toaccumulate cases after completing enrollment of the first patient in January 2018.
In addition to these initiatives toward the approval of additional indications, the Company entered into an
exclusive license agreement with Eagle Pharmaceuticals, Inc. (head office: New Jersey, U.S.) (“Eagle”) in
September 2017, under which Eagle licensed to the Company rights under Eagle’s intellectual property todevelop, market, and sell Eagle’s TREAKISYM® liquid formulation (RTD and RI liquid formulations) (Note1) in Japan. This will further enable the Company to extend the product life until 2031 through patent

protection and maximize the value of TREAKISYM®, while bringing significant benefits to patients andhealthcare providers. The Company has already consulted with the Pharmaceutical and Medical Devices
Agency regarding details of the application for approval of the RTD formulation and clinical trial designfor the RI formulation, and is preparing for the launch of TREAKISYM® liquid formulation upon obtaining
approval in FY2021 or later.
Further, the Company acquired approval for the partial revision to the marketing authorization in July
2018. As a result, TREAKISYM® can now be used in combination with not only rituximab but also
obinutuzumab (Note 2) (launched in August 2018) for the treatment of CD20 positive follicular lymphoma(FL), a common histologic type of low-grade NHL, enabling the Company to provide patients with a newtreatment therapy. In September 2018, the Company applied for approval of partial revision to the
manufacturing and marketing authorization of TREAKISYM® regarding its use as a pre-treatment forregenerative medicine products.

-1-

In addition to the intravenous formulation currently under development and on sale, the Company is
exploring the potential of TREAKISYM® as the treatment for solid tumors and autoimmune diseases
through the development of an oral formulation, with an aim to solidify its business through a platform of
TREAKISYM® products. Amid such initiatives, the Company commenced a Phase I clinical trial for
progressive solid tumors in January 2018, with the aims of examining the recommended dosage andadministration schedule as well as tolerability and safety of the oral formulation of TREAKISYM®, andidentifying potential target tumor types. After completing enrollment of the first patient in May 2018, theCompany is currently working to accumulate cases. Meanwhile, with a view to evaluating the effect of oral
administration of TREAKISYM® on the immune system, the Company concluded a joint research
agreement with Keio University in May 2018 to conduct a pre-clinical trial to verify the therapeutic valueof this product in the treatment of systemic lupus erythematosus (SLE), a form of autoimmune disease. The
pre-clinical trial is currently underway.
(Note 1) RTD and RI are pre-dissolved liquid formulations that differ from the currently available freezedried (“FD”) powder formulation. 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 patientsand healthcare providers.
(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 toCD20 (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.
[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
a global Phase III clinical trial (with trial sites in more than 20 countries) of the intravenous formulation ofrigosertib for higher-risk myelodysplastic syndromes (HR-MDS) which do not respond to the current
standard treatment with hypomethylating agents, which relapse after treatment under the current standardof care, or which are intolerant to hypomethylating agents. The Company is responsible for clinicaldevelopment in Japan and in December 2015 began the trial. Thirty-seven patients were enrolled as of
September 30, 2018, and patient enrollment is proceeding favorably. Based on the results of the interim
analysis completed in January 2018, the Company will continue the trial with a one-time increase in patient
enrollment in accordance with statistical criteria in an adaptive design previously agreed upon with the U.S.
Food and Drug Administration (FDA). Based on the results of the trial, the Company is planning to apply
for approval in Japan at the same time as in the U.S. and Europe.
As for the oral formulation of rigosertib, Onconova has been conducting Phase I/II clinical trials in the
U.S. for the target indication of first-line HR-MDS (in combination with azacitidine (Note 3)), along with a
Phase II clinical trial for the target indication of transfusion-dependent lower-risk MDS. The Company
started a domestic Phase I clinical trial in June 2017 to confirm the tolerability and safety of the oral
formulation of rigosertib for Japanese patients. The first patient was enrolled in October 2017 and patient
enrollment is proceeding favorably. After completion of this trial, the Company plans to conduct a clinical
trial for combination therapy with azacitidine, to take part in Onconova’s planned global Phase III clinical
trial for combination therapy with azacitidine for the first-line treatment of patients with higher-risk MDS,
and to apply for approval of the oral formulation of rigosertib in Japan in timing alignment with the U.S.
and Europe. With respect to the development for the target indication of transfusion-dependent lower-risk-2-

MDS, the Company will continue to monitor Onconova’s development activities with a view toparticipating from Japan.
(Note 3) Azacitidine (Vidaza®: currently marketed by Nippon Shinyaku Co., Ltd.): This drug (forinjection) was approved in 2011 based on results showing extended overall survival for the firsttime in the Phase III clinical trial for the indication of MDS. It is currently used as a first-choice
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.
[Patient-controlled iontophoretic transdermal system for the short-term management of acute postoperative pain: SyB P-1501]
In October 2015, the Company entered into an agreement with Incline Therapeutics, Inc., a whollyowned subsidiary of US-based The Medicines Company (Head Office: New Jersey, U.S.) for an exclusive
license to develop and commercialize SyB P-1501 in Japan. The Company, acting in the best interest ofpatients, determined to temporarily suspend new patient enrollment for SyB P-1501 from April 21, 2017
due to its arising concern as to the continuity of The Medicines Company’s business regarding the product.
The Company later initiated arbitration against The Medicines Company on October 11, 2017 under therules of the International Chamber of Commerce, seeking damages of 82 million U.S. dollar(approximately 9.0 billion yen) arising from The Medicines Company’s repudiation of the license
agreement. The Company claims that The Medicines Company failed to provide the Company withadequate assurance of performance of its contractual obligations under the license agreement in light of its
decision to discontinue commercialization activities regarding the product and withdraw from markets in
the U.S. and Europe, and that such failure by The Medicines Company is a material breach of the license
agreement. Furthermore, the Company terminated the license agreement on November 30, 2017, based on
the fact that breach of the license agreement by The Medicines Company was not remedied within the
stipulated time, and terminated the development of SyB P-1501 on February 9, 2018.
Arbitration proceedings against The Medicines Company are still ongoing.
[New drug candidates]
The Company continues to actively seek new drug candidates and in-licensing opportunities globally,
aiming to expand both profitability and growth potential over the medium-to-long-term, and discussions
with multiple potential licensors are ongoing.
In May 2016, the Company established a wholly-owned subsidiary, SymBio Pharma USA, Inc. (Menlo
Park, California, U.S., “SymBio Pharma USA”), as the Company’s planned strategic base for overseas
business development. Acquiring rights to new drug candidates through SymBio Pharma USA as the baseof global business will be part of the Company’s continued transformation into a global specialty
biopharmaceutical company with capability to develop and commercialize new drugs in the U.S., Japan,
Europe, and other major global markets.
(ii) Markets outside Japan
SyB L-0501 is also marketed in South Korea, Taiwan and Singapore and the product sales of SyB L0501 in these countries progressed mainly in line with the Company’s forecasts.
(iii) Business results (cumulative)-3-

As a result of the above, net sales totaled 3,032,365 thousand yen for the first nine months of fiscal year
ending December 31, 2018, primarily reflecting product sales of TREAKISYM®. Overall net sales rose
25.5% year-on-year.
Selling, general and administrative expenses totaled 2,831,731 thousand yen (a year-on-year decrease of
32.3%), including research and development (“R&D”) expenses of 1,293,080 thousand yen (a year-on-year
decrease of 52.3%) primarily due to expenses associated with the clinical trial for the intravenous and oral
formulations of TREAKISYM® as well as the intravenous and oral formulations of rigosertib, and otherselling, general and administrative expenses of 1,538,651 thousand yen (a year-on-year increase of 4.6%).
As a result, an operating loss of 1,907,504 thousand yen was recognized for the first nine months offiscal year ending December 31, 2018 (compared to an operating loss of 3,508,173 thousand yen for the
first nine months of the previous fiscal year). In addition, including non-operating expenses totaling 33,634
thousand yen primarily comprised of share issuance costs, ordinary loss totaled 1,937,509 thousand yen(compared to an ordinary loss of 3,546,844 thousand yen for the first nine months of the previous fiscal
year) and net loss totaled 1,940,842 thousand yen (compared to a net loss of 3,546,022 thousand yen for the
first nine months of the previous fiscal year).
Segment information has been omitted as the Company operates within a single segment of thepharmaceutical industry, which includes the development and commercialization of drugs, manufacturing,marketing and other related activities.
(2) Qualitative information concerning financial position
Total assets as of September 30, 2018 stood at 5,466,799 thousand yen, an increase of 1,214,514 thousand yen
from the previous fiscal year end. The increase was primarily due to increases of 895,001 thousand yen in cash
and deposits, 381,812 thousand yen in accounts receivable-trade, and 20,131 thousand yen in advances paid,
offsetting a decrease of 40,013 in merchandise and finished goods, 34,416 thousand yen in consumption taxes
receivable, 14,359 thousand yen in lease and guarantee deposits, and 13,667 thousand yen in software.
Liabilities stood at 821,282 thousand yen, a decrease of 191,599 thousand yen from the previous fiscal year
end, primarily reflecting a decrease of 247,300 thousand yen in accounts payable-trade and 15,323 thousand yen
in income taxes payable, offsetting increases of 67,109 thousand yen in accounts payable-other .
Net assets increased by 1,406,114 thousand yen from the previous fiscal year end to 4,645,517 thousand yen,
due to increases of 1,639,634 thousand yen in common stock, 1,639,634 thousand yen in capital surplus, and67,687 thousand yen in stock acquisition rights, offsetting a decrease of 1,940,842 thousand yen in retained
earnings following the recognition of net loss.
As a result, the equity ratio rose by 10.4 percentage points to 73.9% from the previous fiscal year end.
(3) Qualitative information concerning earnings forecasts
No revision was made to the earnings forecasts for FY 2018 as of the date of this document.

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2. Quarterly Financial Statements and Primary Notes(1) Quarterly balance sheets(Unit: thousands of yen)
FY 2017Q3 FY 2018(as of December 31, 2017) (as of September 30, 2018)
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
Long-term prepaid expenses
Lease 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
Net assets
Shareholders’ equity
Common stock
Capital surplus
Retained earnings (accumulated deficits)-5-2,947,059
489,874
362,51473,72018,76098,44046,152
4,036,522

3,842,060
871,687
322,501
81,58238,89264,02456,267
5,277,016

28,48618,32264
46,87337,586
21,780－59,366

65,583
3,295
68,87851,916－
51,9160
14,20985,799100,008
215,761
4,252,284

0
7,059
71,43978,499189,782
5,466,799

604,382
330,867
54,813
21,427
1,011,490

357,081
397,976
39,48925,525820,074

1,392
1,392
1,012,882

1,208
1,208
821,282

10,761,676
10,731,676(18,790,705)

12,401,311
12,371,311(20,731,548)

Treasury stock
Total shareholders’ equity
Stock acquisition rights
Total net assets
Total liabilities and net assets(17)
2,702,629
536,772
3,239,402
4,252,284

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(17)
4,041,057
604,459
4,645,517
5,466,799

(2) Quarterly statements of income (cumulative)(For the first nine months of the fiscal year ending December 31, 2018)

Net sales
Cost of goods sold
Gross profit
Selling, general and administrative expenses
Operating loss
Non-operating income
Interest income
Interest on refund
Dividend income of insurance
Foreign exchange gains
Other
Total non-operating income
Non-operating expenses
Commission fees
Stock issuance costs
Foreign exchange losses
Other
Total non-operating expenses
Ordinary loss
Extraordinary gain
Gain on reversal of stock acquisition rights
Total extraordinary gain
Extraordinary loss
Loss on retirement of non-current assets
Total extraordinary loss
Loss before income taxes
Income taxes-current
Total income taxes
Net loss-7-

Q3 FY 2017(from January 1, 2017
to September 30, 2017)
2,416,625
1,741,953
674,672
4,182,845(3,508,173)(Unit: thousands of yen)
Q3 FY 2018(from January 1, 2018
to September 30, 2018)
3,032,365
2,108,138
924,227
2,831,731(1,907,504)

3,058
－
1,339
－
75
4,473

491
116
1,501
1,466
54
3,629

6,747
11,67324,481240
43,144(3,546,844)

8,302
25,332－－
33,634(1,937,509)

3,671
3,671

9,346
9,346

－
－
(3,543,172)
2,850
2,850
(3,546,022)

9,829
9,829
(1,937,992)
2,850
2,850
(1,940,842)

(3) Notes on quarterly financial statements(Notes regarding going concern assumption)
None to be reported.
(Notes regarding significant changes in shareholders’ equity)
During the first nine months of fiscal year ending December 31, 2018, new shares were issued
upon the exercise of part of the 33rd, 36th, 42nd, and 45th stock acquisition rights. As a result, during
the first nine months of fiscal year ending December 31, 2018, common stock and capital surplus
increased by 1,639,634 thousand yen and 1,639,634 thousand yen respectively, amounting to
12,401,311 thousand yen and 12,371,311 thousand yen respectively as of September 30, 2018.
(Significant subsequent events)
None to be reported.

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