English translation

Summary of Financial Results
For the First Quarter of Fiscal Year Ending December 31, 2014
[Japanese GAAP] (Non-consolidated)
May 8, 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 Report

May 9, 2014

Date of dividend
payment (plan)－

Supplementary materials for the 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 Quarter of FY 2014 (January 1, 2014 to March 31, 2014)(1) Operating Results (cumulative)(Percentage indicates year-on-year change)
Quarterly Net Income
Net Sales
Operating Income (loss) Ordinary Income (loss)(loss)
millions of yen%

millions of yen%

millions of yen%

millions of yen

%

173
489

(64.5)(15.8)

(415)
(341)

－
－

(453)
(352)

－
－

(454)
(353)

－
－

1Q FY 2014
1Q FY 2013

Quarterly Net Income(loss) per share

Diluted Quarterly Net
Income per shareYen
Yen
1Q FY 2014(14.85)－
1Q FY 2013(16.52)－(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
1Q FY 2014 (as of March 31, 2014)
FY 2013 (as of December 31, 2013)(Reference) Equity:

Net Assets

millions of yen
7,419
7,686

Equity Ratio

millions of yen
6,991
7,432

1Q FY 2014 (as of March 31, 2014)

6,877 million yen

FY 2013 (as of December 31, 2013)

7,336 million yen

%
92.7
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

(Note) Revisions to the dividends forecasts most recently announced:－
Yes ・ No

0.00

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)

1Q FY 2014

30,634,257 shares

FY 201330,634,257 shares

1Q FY 201475 shares

FY 201375 shares

1Q FY 2014

30,634,182 shares

1Q FY 2013

21,392,852 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 first 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…………………………………………………………………………………………………..

5

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 first 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 first 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 SyB L-0501 in Japan through its business partner Eisai Co., Ltd. (hereinafter “Eisai”), for theindications 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 EU regulatory agency.
The Phase II clinical trial for the indication of chronic lymphocytic leukemia was initiated in May 2013, and favorable
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 SyB L-1101 (intravenous formulation) for the indication of refractory/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 intends to consult with the US and EU regulatory agencies about its future development policy for this agent.
Based on such development policy determined by Onconova, the Company will reassess the development plan for theseagents in Japan. Meanwhile, the Company will continue the on-going Phase I clinical trial in Japan.
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
SyB L-0501 sales remained stable in South Korea, Taiwan and Singapore. In Singapore and South Korea, the Company
sells the product through Eisai, as we do in Japan, and the sales figures have been growing steadily as planned.
(iii) Business results
As a result of the above, net sales totaled 173,681 thousand yen for the first quarter of the fiscal year ending December
31, 2014, primarily reflecting sales of SyB L-0501 in Japan and the other Asia Pacific territories. The net sales amount was
decreased by 64.5% compared to the first quarter of the previous year by following review of the current market inventory
level of TREAKISYM®.
On the other hand, selling, general and administrative expenses totaled 447,904 thousand yen (a year-on-year decrease of
9.0%), including research and development (“R&D”) expenses of 178,963 thousand yen (a year-on-year decrease of 35.5%)
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 268,940 thousand yen (a year-on-year increase of 25.4 %).
As a result, operating loss of 415,544 thousand yen was recognized for the first quarter of the fiscal year ending
December 31, 2014 (operating loss of 341,025 thousand yen for the first quarter of the previous fiscal year). In addition,
recording of amount totaling 44,596 thousand yen as non-operating expenses, primarily comprising foreign exchange losses,
led to ordinary loss of 453,905 thousand yen (ordinary loss of 352,425 thousand yen for the first quarter of the previous
fiscal year) and net loss of 454,855 thousand yen (net loss of 353,375 thousand yen for the first quarter of the previous fiscal
year).

-1-

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

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 positions
Total assets as of March 31, 2014 stood at 7,419,394 thousand yen, a decrease of 267,552 thousand yen from the previous
fiscal year end. This was primarily due to a net loss for the three months period.
Total assets stood at 7,419,394 thousand yen, a decrease of 267,552 thousand yen from the previous fiscal year end,
which consisted of increase in: marketable securities of 395,729 thousand yen, merchandise and finished goods of 241,100
thousand yen, property, plant and equipment of 15,446 thousand yen and intangible assets of 28,831 thousand yen anddecrease in: cash and deposits of 875,941 thousand yen, advances paid of 28,703 thousand yen and other current assets of
35,227 thousand yen.
Total liabilities stood at 427,740 thousand yen, an increase of 173,789 thousand yen from the previous fiscal year end,
primarily due to an increase in accounts payable of 243,548 thousand yen.
Net assets decreased by 441,342 thousand yen from the previous fiscal year end to 6,991,653 thousand yen primarily due
to a net loss of 454,855 thousand yen for the first quarter.
As a result, the equity ratio decreased by 2.7 percentage points to 92.7% 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.

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SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the first 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)

1Q FY 2014(as of March 31, 2014)

AssetsCurrent assets
Cash and deposits
Marketable securities
Merchandise and finished goods
Prepaid expenses
Advances paid
Other
Total current assets

6,163,231

5,287,289

1,100,270
125,056

1,495,999
366,157

64,30687,86254,49559,15893,23558,008

7,633,962

7,321,107

2,444
6,187

2,387
10,290－11,401

8,632

24,079

5,898

5,291
29,600Noncurrent 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
Lease assets

－
1,891

Total intangible assets

7,789

36,621Long-term prepaid expenses
Lease and guarantee deposits

9,427
27,135

7,796
29,790Total investments and other assets

36,56237,587

1,729

Investments and other assets

Total noncurrent assets

52,98598,287

7,686,947

7,419,394

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

243,548
153,927

Income taxes payable
Other

22,554
21,252

9,396
18,186

Total current liabilities

250,941425,058

1,675

1,520

Other

1,334

1,162

Total noncurrent liabilities

3,009

2,682

253,950

427,740

Total assets
Liabilities
Current liabilities

Noncurrent liabilities
Provision for retirement benefits

Total liabilities-3-

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

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

1Q FY 2014(as of March 31, 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)(9,206,491)(17)

Total shareholders' equity

7,336,067

6,881,211

167(4,001)

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

(4,001)

96,761

114,4437,432,996

6,991,653

7,686,947

7,419,394

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the first quarter of fiscal year ending December 31, 2014(2) Statements of operations (cumulative)(For the first quarter of the fiscal year ending December 31, 2014)(Unit: thousands of yen)
1Q FY 2013
(from January 1, 2013
to March 31, 2013)
489,016

1Q FY 2014
(from January 1, 2014
to March 31, 2014)
173,681

Cost of sales

338,032

141,322

Gross profit

150,984

32,359Net sales

Selling, general and administrative expenses

492,009447,904

Operating loss

(341,025)(415,544)

1,421

3,692

359
102

2,345
197

1,883

6,235

Interest expenses
Commission fee

8
2,663

51
2,367

Stock issuance cost
Foreign exchange losses

4,484
6,028

101
42,076

Non-operating income
Interest income
Interest on securities
Other
Total non-operating income
Non-operating expenses

100－

13,284

44,596

Ordinary loss

(352,425)(453,905)

Loss before income taxes(352,425)(453,905)

Income taxes-current

950

950

Total income taxes

950

950

(353,375)(454,855)

Other
Total non-operating expenses

Net loss-5-

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the first 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)
None to report(Significant subsequent events)(a) Issuance of the stock option (the stock acquisition right) to the Company’s Directors
At the Board of Directors’ meeting held on April 15, 2014, it was resolved to issue 2,520 units of stock acquisition rights
as a stock option to five (5) Directors of the Company as follows, based upon the resolution of the Shareholders’ meeting heldon March 27, 2014. The stock option was allotted to the relevant Directors on the allotment date of April 30, 2014.
Number of the stock option
Class and number of shares
underlying the stock option
Issue price of the stock option andTotal issue priceAmount to be paid in for the stock
option2,520 units
Common stock

252,000 shares

Issue priceTotal issue price

22,900 yen
57,708,000 yen

Amount to be paid in for the stock option: 229 yen per share
The person who receives the allotment of stock acquisition rights shall set off
his/her claims for compensation against the Company in lieu of payment of monies
for the stock acquisition rights allotted.

Exercise price of the stock option

Exercise price per share 1 yen

Period during which the stock
option can be exercised

From April 16, 2017 to April 15, 2024
(1) The person allotted shall be the Director, Audit & Supervisory Board Member
or employee of the Company or its affiliates at the time of exercise. However, it

Terms and conditions for the
exercise of the stock option

shall not be applied when: (a) the person is resigned from the Company or its
affiliates due to the expiry of her/his term, (b) the person is retired from theCompany or its affiliates due to the compulsory retirement and (c) the Board of
Directors meeting resolves that he/she has resigned or retired amicably.
(2) For other terms and conditions, “Stock Option Allotment Agreement” which
will be concluded between the Company and Directors shall be complied with.

Paid-in capital amount increased

Amount of paid-in capital to be increased due to the issuance of shares upon
exercise of the stock option shall be half of the maximum amount of paid-in capital

due to the issuance of shares upon
exercise of the stock option

increase and others which is calculated in accordance with Article 17 of the
Corporation Accounting Regulations, and any fraction less than one (1) yen arising
therefrom shall be rounded up to the nearest one (1) yen.

Matters concerning transfer of thestock option

It requires the approval of the Board of Directors’ meeting.

-6-

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the first quarter of fiscal year ending December 31, 2014(b) Issuance of the stock option (the stock acquisition right) to the Company’s employees
At the Board of Directors’ meeting held on April 15, 2014, it was resolved to issue 3,300 units of stock acquisition rights
as a stock option to 68 employees of the Company as follows, based upon the provisions set forth in Article 236, 238 and 240of the Companies Act. The stock option was allotted to the relevant employees on the allotment date of April 30, 2014.
Number of the stock option

3,300 units

Class and number of shares
underlying the stock option

Common stock

Issue price of the stock option andIssue price

22,900 yen

Total issue price75,570,000 yen

Total issue price

330,000 shares

Amount to be paid in for the stock option: 229 yen per share
Amount to be pain in for the stock
optionThe person who receives the allotment of stock acquisition rights shall set off
his/her claims for compensation against the Company in lieu of payment of monies
for the stock acquisition rights allotted.

Exercise price of the stock option

Exercise price per share 1 yen

Period during which the stock option
can be exercised

From April 16, 2017 to April 15, 2024
(1) The person allotted shall be the Director, Audit & Supervisory Board Member
or employee of the Company or its affiliates at the time of exercise. However, it

Terms and conditions for the
exercise of the stock option

shall not be applied when: (a) the person is resigned from the Company or its
affiliates due to the expiry of her/his term, (b) the person is retired from theCompany or its affiliates due to the compulsory retirement and (c) the Board of
Directors meeting resolves that he/she has resigned or retired amicably.
(2) For other terms and conditions, “Stock Option Allotment Agreement” which
will be concluded between the Company and the employee shall be compliedwith.

Paid-in capital amount increased due

Amount of paid-in capital to be increased due to the issuance of shares upon
exercise of the stock option shall be half of the maximum amount of paid-in capitalto the issuance of shares upon
exercise of the stock option

increase and others which is calculated in accordance with Article 17 of the
Corporation Accounting Regulations, and any fraction less than one (1) yen arising
therefrom shall be rounded up to the nearest one (1) yen.

Matters concerning transfer of thestock option

It requires the approval of the Board of Directors’ meeting.

-7-