English translation

Summary of Financial Results
For the Third Quarter of Fiscal Year Ending December 31, 2014
[Japanese GAAP] (Non-consolidated)
November 7, 2014
Company Name

SymBio Pharmaceuticals Limited

Listing: Tokyo Securities Exchange

Securities Code4582

URL: http://www.symbiopharma.com/

Representative

Representative Director,
President and Chief Executive Officer

Fuminori Yoshida

Director, Finance & Accounting

Contact Person
Scheduled Date to File
Quarterly Report

Tetsuya Maruyama
Date of dividend
payment (plan)

November 10, 2014

Supplementary materials for the quarterly financial results:YesNoHolding of quarterly earnings performance review:

Yes

NoTEL 03(5472)1125－(millions of yen – rounded down, unless otherwise stated）
1. Business Results for the Third Quarter of FY 2014 (January 1, 2014 to September 30, 2014)(1) Operating Results (cumulative)(Percentage indicates year-on-year change)
Quarterly Net Income
Operating Income (loss) Ordinary Income (loss)(loss)Net Sales
millions of yen%millions of yen%millions of yen%millions of yen%

1,348
1,323

1.9
(12.8)(966)(1,192)－－(940)(1,187)－－(943)(1,190)－－

3Q FY 2014
3Q FY 2013

Quarterly Net Income(loss) per share

Diluted Quarterly Net
Income per share

YenYen3Q FY 2014(30.80)－3Q FY 2013(52.93)－(Note) Diluted quarterly net income per share is not stated above due to quarterly net loss per share, although there are potential
diluted shares.
(2) Financial Position
Total Assets
3Q FY 2014 (as of September 30, 2014)
FY 2013 (as of December 31, 2013)(Reference) Equity:

millions of yen
6,857
7,686

Net Assets

Equity Ratio

millions of yen
6,593
7,432

3Q FY 2014 (as of September 30, 2014)

6,431 million yen

FY 2013 (as of December 31, 2013)

7,336 million yen%
93.895.4

2. Dividends

FY 2013
FY 2014
FY 2014 (Forecast)

1st quarter
Yen－－

Annual Dividend per share
2nd quarter3rd quarter
Fiscal Year EndYen
Yen
Yen
0.00
－0.00
0.00
－0.00

(Note) Revisions to the dividends forecasts most recently announced:

Yes ・ No

Full year
Yen
0.00
0.00

3. Earnings Forecasts for FY 2014 (January 1, 2014 to December 31, 2014)
Operating
Income (loss)

Net Sales(Percentage indicates year-on-year change)
Net Income (loss)
Net Income (loss)
per share

Ordinary
Income (loss)

millions ofyen%millions ofyen%millions ofyen%millions ofyen%

Yen

1,785

16.5

(1,654)－(1,650)－(1,654)－(52.63)

Full Year

(Note) Revisions to the earnings forecasts most recently announced:

Notes:(1) Application of special accounting treatment in
preparation of quarterly financial reports:

Yes ・ NoYes ・ No

(2) Changes in accounting policies, changes in accounting estimates and restatements after error corrections(a) Changes in accounting polices due to revisionof accounting standards:(b) Changes in accounting polices due to otherreason:

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 ofthe 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)

3Q FY 2014

30,724,257 shares

FY 201330,634,257 shares

3Q FY 201475 shares

FY 201375 shares

3Q FY 2014

30,638,138 shares

3Q FY 2013

22,495,451 shares* The status of the quarterly review
The review of quarterly financial statements as required by the Financial Instruments and Exchange Act is proceeding as of thedate of this disclosure document.
* Explanation regarding the appropriate uses of earnings forecasts and other matters
All forecasts presented in this document including earnings forecasts are based on the information currently available to themanagement and the assumptions that we judge reasonable. Actual results may differ substantially from these forecasts due tovarious factors. Regarding the assumptions on which the earnings forecasts are based and its usage, please refer to “1.
Qualitative Information Concerning Quarterly Financial Results, (3) Qualitative information concerning earnings forecasts” onPage 2 of the attachment.

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the third quarter of fiscal year ending December 31, 2014

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 …………………………………………….……………………

2(3) Qualitative information concerning earnings forecasts …………………………………………………………………

2

2. Quarterly Financial Statements ………………………………………………………………………………………….….

3(1) Balance sheets …………………………………………………………………………………………………………..

3(2) Statements of operations (cumulative)…………………………………………………………………………………..

5(3) Notes on quarterly financial statements …………………………………………………………………………………

6(Notes concerning going concern assumption) ……………………………………………………………………………

6(Notes concerning significant changes in shareholders’ equity) ………………………………….………………………

6(Significant subsequent events) …………………………………………………………..……………….………………

6SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the third quarter of fiscal year ending December 31, 2014

1. Qualitative Information Concerning Quarterly Financial Results(1) Qualitative information concerning business results
Progress in the Company’s business for the third quarter of FY 2014 is as follows:(i) Domestic[Anticancer agent SyB L-0501 (the generic name: bendamustine hydrochloride, the trade name: TREAKISYM®)]
The Company has marketed anticancer agent SyB L-0501 in Japan through its business partner Eisai Co., Ltd.
(hereinafter “Eisai”), for the indications of refractory/relapsed indolent non-Hodgkin’s lymphoma and mantle celllymphoma.
The Company has also conducted three clinical trials on TREAKISYM® for additional indications.
With respect to the Phase II clinical trial for the indications of previously untreated indolent non-Hodgkin’s lymphoma
and mantle cell lymphoma, the Company completed the trial in February 2014 and is currently preparing for the application
for approval. In the EU, Astellas Pharma Europe Ltd. (“Astellas EU”) has already completed the application process for theregulatory approval. Considering this approval progress, the Company plans to file an application for manufacturing andmarketing approval in Japan.
The Phase II clinical trial for the indication of chronic lymphocytic leukemia was initiated in May 2013, and progress has
been made with enrollment of patients. In this connection, TREAKISYM® was designated an orphan drug (pharmaceuticalfor treatment of rare diseases) for the indication of chronic lymphocytic leukemia during June 2012.
Discussion about future approaches to development for refractory/relapsed aggressive non-Hodgkin’s lymphoma is being
continued with the Pharmaceuticals and Medical Devices Agency.
[Anticancer agents SyB L-1101 (intravenous formulation) and SyB C-1101 (oral formulation), the generic name: rigosertib]
The Japanese Phase I clinical trial on anticancer agent SyB L-1101 (intravenous formulation) for the indication ofrefractory/relapsed myelodysplastic syndrome (MDS), which is a hematological malignancy, is in progress.
During February 2014, Onconova Therapeutics, Inc. (“Onconova”), the US company from which these agents werelicensed in, released the results of the Phase III clinical trial (ONTIME trial, intravenous formulation), carried out in Europe
and the US, in patients with refractory/relapsed (higher risk) MDS. In these results, although no statistically significant
difference in the primary endpoint, overall survival time, was found in comparison with the best supportive care (BSC), theresults of subpopulation analysis suggest that there was such a statistically significant difference in the group of patients
consisting of those who showed progressive disease or no response during previous treatment with hypomethylating agents(“HMA”).
Onconova continued its discussions with the US FDA and European regulatory agencies regarding the possibility ofapproval based on the top-line results of the Phase III ONTIME trial. These discussions have consequently led Onconova tofocus its development efforts on the unmet medical need of patients who do not respond to initial treatment with the current
standard of care hypomethylating agents (“Primary HMA Failure”). Onconova announced a development plan for Primary
HMA Failure.
The Company will continue Phase I clinical trial in Japan and reassess the domestic development plan by contemplating
Onconova’s development plan which will be announced in due course.
In addition, the Japanese Phase I clinical trial on SyB C-1101 (oral formulation) as a frontline treatment for MDS is beingcontinued.
(ii) Overseas
In June 2014, SyB L-0501 was approved in South Korea for the indication of refractory/relapsed indolent non-Hodgkin’s
lymphoma in addition to the earlier approval for the indications of chronic lymphocytic leukemia and multiple myeloma.
Eisai Korea Inc., a Korean subsidiary of Eisai Co., Ltd., promotes the product for these three indications. The Company
sells the product in Taiwan through InnoPharmax Inc. In Singapore, the Company sells the product through Eisai, as is thecase in Japan or Korea. The Company’s sales in each country have been growing steadily as planned.
(iii) Business results
As a result of the above, net sales totaled 1,348,206 thousand yen for the third quarter of the fiscal year ending December
31, 2014, primarily reflecting product sales of SyB L-0501 in Japan and overseas. The net domestic sales of TREAKISYM®
showed a year-on-year increase of 0.4%. Besides, while the net overseas sales increased by 2.3 times compared to the thirdquarter of the previous year, the milestone revenue showed a year-on-year decrease of 85.0%. In total, the net sales
increased by 1.9% compared to the third quarter of the previous year.

-1-SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the third quarter of fiscal year ending December 31, 2014

On the other hand, selling, general and administrative expenses totaled 1,320,137 thousand yen (a year-on-year decreaseof 10.0%), including research and development (“R&D”) expenses of 545,345 thousand yen (a year-on-year decrease of33.2%) primarily due to expenses associated with the clinical trials for SyB L-0501, SyB L-1101 and SyB C-1101, as wellas other selling, general and administrative expenses of 774,792 thousand yen (a year-on-year increase of 19.1 %).
As a result, operating loss of 966,650 thousand yen was recognized for the third quarter of the fiscal year ending
December 31, 2014 (operating loss of 1,192,955 thousand yen for the third quarter of the previous fiscal year). In addition,
recording of non-operating income totaling 33,375 thousand yen, primarily comprising foreign exchange gains, led toordinary loss of 940,772 thousand yen (ordinary loss of 1,187,907 thousand yen for the third quarter of the previous fiscal
year) and net loss of 943,652 thousand yen (net loss of 1,190,757 thousand yen for the third quarter of the previous fiscal
year).
Segment information is omitted since the Company operates a single segment of pharmaceutical business including
research and development of pharmaceutical drugs as well as manufacturing, marketing and other related activities.
(2) Qualitative information concerning financial position
Total assets as of September 30, 2014 stood at 6,857,698 thousand yen, a decrease of 829,249 thousand yen from theprevious fiscal year end, which consisted of increase in: marketable securities of 395,466 thousand yen, merchandise andfinished goods of 110,596 thousand yen, property, plant and equipment of 14,972 thousand yen and intangible assets of
57,344 thousand yen and decrease in: cash and deposits of 1,308,454 thousand yen, prepaid expenses of 21,807 thousandyen, advances paid of 46,143 thousand yen and other current assets of 65,603 thousand yen.
Total liabilities stood at 263,959 thousand yen, an increase of 10,008 thousand yen from the previous fiscal year end,primarily due to an increase in accounts payable of 107,841 thousand yen and a decrease in accounts payable-other of
85,246 thousand yen.
Net assets decreased by 839,257 thousand yen from the previous fiscal year end to 6,593,738 thousand yen primarily due
to a net loss of 943,652 thousand yen for the third quarter.
As a result, the equity ratio decreased by 1.6 percentage points to 93.8% from the previous fiscal year end.

(3) Qualitative information concerning earnings forecasts
No revision is made to the earnings forecasts for FY 2014 as of the date of this document.

-2-SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the third quarter of fiscal year ending December 31, 2014

2. Quarterly Financial Statements(1) Balance sheets(Unit: thousands of yen)
FY 2013(as of December 31, 2013)

3Q FY 2014(as of September 30, 2014)

AssetsCurrent assets
Cash and deposits
Marketable securities
Merchandise and finished goods
Prepaid expenses
Advances paid
Other6,163,231

4,854,776

1,100,270
125,056

1,495,736
235,652

64,30687,86242,49941,71893,23527,631

7,633,962

6,698,014

Buildings, netTools, furniture and fixtures, net

2,444
6,187

1,978
21,626

Total property, plant and equipment

8,632

23,604

Total current assets
Noncurrent assets
Property, plant and equipment

Intangible assets
Software

5,898

4,368

Software in progress
Lease assets－1,891

59,361
1,405

Total intangible assets

7,789

65,134

Investments and other assets
Long-term prepaid expenses

9,427

2,160

Lease and guarantee deposits

27,13568,783

Total investments and other assets

36,562

70,944

Total noncurrent assets

52,985

159,683

7,686,947

6,857,698

107,841

Accounts payable-other
Income taxes payable－
207,134
22,554Other

21,252

22,340Total current liabilities

250,941

261,535

1,675
1,334

1,608
816

Total assets
Liabilities
Current liabilities
Accounts payable-trade121,888
9,465

Noncurrent liabilities
Provision for retirement benefits
Other
Total noncurrent liabilities
Total liabilities-3-3,009

2,424

253,950

263,959

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the third quarter of fiscal year ending December 31, 2014

(Unit: thousands of yen)
FY 2013(as of December 31, 2013)

3Q FY 2014(as of September 30, 2014)

Net assets
Shareholders' equity
Capital stock
Capital surplus

8,058,860
8,028,860

8,080,775
8,050,775

Retained earnings
Treasury stock(8,751,636)(17)(9,695,288)(17)

Total shareholders' equity

7,336,067

6,436,245

167(4,264)167(4,264)

Valuation and translation adjustments
Valuation difference on available-for-salesecurities
Total valuation and translation adjustments
Stock acquisition rights
Total net assets
Total liabilities and net assets-4-

96,761

161,757

7,432,996

6,593,738

7,686,947

6,857,698

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the third quarter of fiscal year ending December 31, 2014(2) Statements of operations (cumulative)(For the third quarter of the fiscal year ending December 31, 2014)(Unit: thousands of yen)
3Q FY 2013
(from January 1, 2013
to September 30, 2013)
1,323,544

3Q FY 2014
(from January 1, 2014
to September 30, 2014)
1,348,206

Cost of sales

1,050,394

994,719

Gross profit

273,150

353,487

Selling, general and administrative expenses

1,466,105

1,320,137

Operating loss

(1,192,955)(966,650)

4,853

11,797

Interest on securities
Gain on sales of securities

2,176
5,354

6,612

Interest on tax refunded
Dividend income of insurance

104
1,104

－44
1,116

Foreign exchange gain
Other

4,275
172

13,635169

Total non-operating income18,04133,375

Interest expenses
Commission fee

24
8,077

63
7,180

Stock issuance cost
Other

4,791
100

254

Total non-operating expenses

12,994

7,498(1,187,907)(940,772)

Gain on reversal of stock acquisition rights－

317

Total extraordinary income

－

317

－

347

Net sales

Non-operating income
Interest income

Non-operating expenses

Ordinary loss－

Extraordinary income

Extraordinary loss
Loss on retirement of non-current assets
Total extraordinary loss－

347

Loss before income taxes(1,187,907)(940,802)

Income taxes-current

2,850

2,850

Total income taxes

2,850

2,850(1,190,757)(943,652)

Net loss-5-

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the third quarter of fiscal year ending December 31, 2014

(3) Notes on quarterly financial statements(Notes concerning going concern assumption)
None to report(Notes concerning significant changes in shareholders’ equity)
No significant changes in the amount of shareholders’ equity compared to previous fiscal year end.
(Significant subsequent events)
None to report-6-