English translation

Summary of Financial Results
For the Second Quarter of Fiscal Year Ending December 31, 2014
[Japanese GAAP] (Non-consolidated)
August 6, 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

Contact Person

Chief Financial Officer andChief Business Officer

Takihiro Hirasawa

TEL 03(5472)1125

Scheduled Date to File
Quarterly ReportAugust 7, 2014

Date of dividend
payment (plan)－

Supplementary materials for the quarterly financial results:

Yes

No

Holding of quarterly earnings performance review:Yes

No (For securities analyst and institutional investors)(millions of yen – rounded down, unless otherwise stated）
1. Business Results for the Second Quarter of FY 2014 (January 1, 2014 to June 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

%

975
810

20.3
(23.1)

(646)
(807)

－
－

(713)
(812)

－
－

(715)
(814)

－
－

2Q FY 2014
2Q FY 2013

Quarterly Net Income(loss) per share

Diluted Quarterly Net
Income per shareYen
Yen
2Q FY 2014(23.35)－2Q FY 2013(36.65)－(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
2Q FY 2014 (as of June 30, 2014)
FY 2013 (as of December 31, 2013)(Reference) Equity:

millions of yen
7,040
7,686

Net Assets

Equity Ratio

millions of yen
6,754
7,432

2Q FY 2014 (as of June 30, 2014)

6,616 million yen

FY 2013 (as of December 31, 2013)

7,336 million yen

%
94.0
95.4

2. Dividends

FY 2013
FY 2014
FY 2014 (Forecast)

1st quarter
Yen－－

Annual Dividend per share
2nd quarter3rd quarter
Fiscal Year End
Yen
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 of
yen

%

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 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)

2Q FY 2014

30,634,257 shares

FY 201330,634,257 shares

2Q FY 201475 shares

FY 201375 shares

2Q FY 2014

30,634,182 shares

2Q FY 2013

22,212,523 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 the
management 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” on
Page 2 of the attachment.

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the second 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) Quarterly cash flow statement……………………………………………………………………………………………

6(4) Notes on quarterly financial statements …………………………………………………………………………………

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

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

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

8

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the second 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 second 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 cell
lymphoma.
The Company has also carried out 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 last enrollment was completed in October 2013, and the study data are currently being
analyzed and evaluated in preparation for submission. The application for approval in the EU has already been submitted byAstellas Pharma Europe, and is currently being reviewed by the European regulatory agency.
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 (pharmaceutical
for 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 iscurrently 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 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.
Onconova has been consulting with the US and European regulatory agencies about its future development policy for thisagent. While continuing the on-going Phase I clinical trial in Japan, the Company will reassess the development plan forthese agents based on such development policy determined by Onconova.
In addition, the Japanese Phase I clinical trial on SyB C-1101 (oral formulation) as a frontline treatment for MDS is being
continued.
(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 975,345 thousand yen for the second 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 21.1%. Besides, while the net overseas sales increased by 3.5 times compared to thesecond quarter of the previous year, the milestone revenue showed a year-on-year decrease of 85.0%. In total, the net sales
increased by 20.3% compared to the second quarter of the previous year.
On the other hand, selling, general and administrative expenses totaled 893,389 thousand yen (a year-on-year decrease of
9.9%), including research and development (“R&D”) expenses of 370,289 thousand yen (a year-on-year decrease of 33.5%)
primarily due to expenses associated with the clinical trials for SyB L-0501, SyB L-1101 and SyB C-1101, as well as otherselling, general and administrative expenses of 523,099 thousand yen (a year-on-year increase of 20.3 %).
As a result, operating loss of 646,260 thousand yen was recognized for the second quarter of the fiscal year ending
December 31, 2014 (operating loss of 807,162 thousand yen for the second quarter of the previous fiscal year). In addition,-1-

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

recording of non-operating expenses totaling 78,919 thousand yen, primarily comprising foreign exchange losses, led toordinary loss of 713,197 thousand yen (ordinary loss of 812,231 thousand yen for the second quarter of the previous fiscal
year) and net loss of 715,355 thousand yen (net loss of 814,131 thousand yen for the second 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 June 30, 2014 stood at 7,040,524 thousand yen, a decrease of 646,422 thousand yen from the previous
fiscal year end, which consisted of increase in: accounts receivable of 227,359 thousand yen, marketable securities of395,330 thousand yen, merchandise and finished goods of 153,276 thousand yen, property, plant and equipment of 16,789
thousand yen and intangible assets of 28,062 thousand yen and decrease in: cash and deposits of 1,365,206 thousand yen,
prepaid expenses of 16,056 thousand yen, advances paid of 49,350 thousand yen and other current assets of 73,279 thousand
yen.
Total liabilities stood at 285,685 thousand yen, an increase of 31,734 thousand yen from the previous fiscal year end,
primarily due to an increase in accounts payable of 150,848 thousand yen and a decrease in accounts payable-other of
119,271 thousand yen.
Net assets decreased by 678,156 thousand yen from the previous fiscal year end to 6,754,839 thousand yen primarily due
to a net loss of 715,355 thousand yen for the second quarter.
As a result, the equity ratio decreased by 1.4 percentage points to 94.0% 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 second 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)

2Q FY 2014(as of June 30, 2014)

AssetsCurrent assets
Cash and deposits

6,163,231

4,798,024－
1,100,270

227,359
1,495,600

Merchandise and finished goods
Prepaid expenses

125,056
64,306278,333
48,250

Advances paid
Other87,862
93,23538,511
19,956

7,633,962

6,906,035

Accounts receivable-tradeMarketable securities

Total current assets
Noncurrent assets
Property, plant and equipment
Buildings, net

2,444

2,030

Tools, furniture and fixtures, net

6,187

23,391

Total property, plant and equipment

8,632

25,421

5,898

4,685
29,600Intangible assets
Software
Software in progress
Lease assets

－
1,891

Total intangible assets

7,789

35,852Long-term prepaid expenses
Lease and guarantee deposits

9,427
27,135

3,855
69,359Total investments and other assets

36,562

73,215

1,567

Investments and other assets

Total noncurrent assets

52,985

134,489

7,686,947

7,040,524

Accounts payable-trade
Accounts payable-other－
207,134

150,848
87,863

Income taxes payable
Other

22,554
21,252

18,792
25,628

Total current liabilities

250,941

283,132

1,675

1,563

Total assets
Liabilities
Current liabilities

Noncurrent liabilities
Provision for retirement benefits
Other

1,334

989

Total noncurrent liabilities

3,009

2,552

253,950

285,685

Total liabilities-3-

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

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

2Q FY 2014(as of June 30, 2014)

Net assets
Shareholders' equity
Capital stock
Capital surplus

8,058,860
8,028,860

8,058,860
8,028,860

Retained earnings
Treasury stock(8,751,636)(17)(9,466,991)(17)

Total shareholders' equity

7,336,067

6,620,712

167(4,400)

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-

167

(4,400)96,761

138,527

7,432,996

6,754,839

7,686,947

7,040,524

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the second quarter of fiscal year ending December 31, 2014(2) Statements of operations (cumulative)(For the second quarter of the fiscal year ending December 31, 2014)(Unit: thousands of yen)
2Q FY 2013
(from January 1, 2013
to June 30, 2013)
810,807

2Q FY 2014
(from January 1, 2014
to June 30, 2014)
975,345

Cost of sales

626,452

728,216Gross profit

184,354

247,128

Net sales

Selling, general and administrative expenses

991,517893,389

Operating loss

(807,162)(646,260)

2,786

7,299

Interest on securities
Interest on tax refunded

1,351
104

4,470
44

Foreign exchange gain
Other

779
172

－
169

5,195

11,983

Interest expenses
Commission fee

16
5,355

57
4,760

Stock issuance cost
Foreign exchange losses

4,791

101
74,000Non-operating income
Interest income

Total non-operating income
Non-operating expenses

－
100

Other
Total non-operating expenses
Ordinary loss
Extraordinary income
Gain on reversal of stock acquisition rights
Total extraordinary income
Extraordinary loss
Loss on retirement of non-current assets－

10,26478,919(812,231)(713,197)

－

89

－

89

－

347

Total extraordinary loss－

347

Loss before income taxes(812,231)(713,455)

1,900

1,900

Income taxes-current
Total income taxes
Net loss

-5-

1,900

1,900

(814,131)(715,355)

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the second quarter of fiscal year ending December 31, 2014(3) Quarterly cash flow statement(Unit: thousands of yen)First six months of Fiscal 2013
(from January 1, 2013
to June 30, 2013)

First six months of Fiscal 2014
(from January 1, 2014
to June 30, 2014)

Net cash provided by (used in) operating activities
Quarterly (loss) before income tax(812,231)(713,455)

Depreciation
Amortization of guarantee deposits

4,081
732

4,061
501

Share-based compensation expenses
Increase (decrease) in provision for retirement
benefitInterest income
Interest expenses

27,93841,765

(129)

(112)

(4,138)16(11,769)
57

Foreign exchange losses (gains)
Stock issuance cost

(10,528)
4,791

63,803
101

5,355

4,760
347

Commission fee
Loss on retirement of non-current assets
Decrease (increase) in accounts receivable
Decrease (increase) in inventories－(19,964)(217,433)(227,359)(153,489)

Decrease (increase) in prepaid expenses
Decrease (increase) in advances paid

31,128(11,340)

11,29649,350Decrease (increase) in consumption taxes receivable
Decrease (increase) in current assets-other

15,401
25,29319,09554,444

Decrease (increase) in long-term prepaid expenses
Increase (decrease) in accounts payable-trade

11,82940,983

5,571
150,848

Increase (decrease) in accounts payable-other
Increase (decrease) in other current liabilities(22,412)(17,567)(119,951)
711

Other

100

(1,455)(948,091)(820,873)

Interest and dividends income received
Interest expense paid

3,551
(16)

11,721(57)

Income taxes paid

(1,900)(1,900)(946,456)(811,100)(488,860)
300,000－
338,419(1,499,205)
300,000(1,000,000)
600,000－(18,980)(29,600)

Subtotal

Net cash provided by (used in) operating activities
Net cash provided by (used in) investing activities
Transfer to time-deposits
Transfer from time-deposits
Purchase of marketable securities
Proceeds from redemption of securities
Purchase of property, plant and equipment
Purchase of intangible assets－－

Payments for lease and guarantee deposits
Proceeds from collection of lease and guarantee
deposits
Net cash provided by (used in) investing activities-6-(41,486)370

216(1,387,695)(151,431)

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

(Unit: thousands of yen)First six months of Fiscal 2013
(from January 1, 2013
to June 30, 2013)

First six months of Fiscal 2014
(from January 1, 2014
to June 30, 2014)

241,598－

1,000,000－

5,100(4,791)

－
(101)

(335)
(100)

(340)

1,241,470

(441)

2,208

(33,129)

Net cash provided by (used in) financing activities
Proceeds from issuance of stock resulting fromexercise of stock acquisition rights
Proceeds from issuance of bonds with stockacquisition rights
Proceed from issuance of stock acquisition rights
Payments for issuance of common stock
Repayments for lease obligations
Other payments－

Net cash provided by (used in) financing activities
Effect of foreign exchange rate change on cash and cash
equivalents
Net increase (decrease) in cash and cash equivalents(1,090,472)(996,112)

Cash and cash equivalents at the beginning of the period

4,240,022

5,294,137

Cash and cash equivalents at the end of the period

3,149,549

4,298,024-7-

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

(4) Notes on quarterly financial statements(Notes concerning going concern assumption)
None to report(Notes concerning significant changes in shareholders’ equity)
None to report(Significant subsequent events)
None to report-8-