English translation

Summary of Financial Results
For the First Quarter of Fiscal Year Ending December 31, 2013
[Japanese GAAP] (Non-consolidated)
May 14, 2013
Company Name

SymBio Pharmaceuticals Limited

Listing: Osaka Securities Exchange

Securities code4582

URL http://www.symbiopharma.com/

Representative

Representative Director, President andChief Executive Officer

Fuminori Yoshida

Contact person

Executive Vice President, CFO andHead of Corporate Div.

Takashi Shimomura

TEL 03(5472)1125

Date of dividend
payment (plan)－

Scheduled date to file quarterly
May 15, 2013
reportSupplementary materials for thequarterly 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 2013 (January 1, 2013 to March 31, 2013)(1) Operating results (cumulative)(Percentages indicate year-on-year changes.)
Quarterly net income
Net sales
Operating income (loss) Ordinary income (loss)(loss)
Millions of yen%

Millions of yen%

Millions of yen%

Millions of yen

%

489
580

(15.8)
66.9

(341)
(480)

－
－

(352)
(515)

－
－

(353)
(516)

－
－

1Q FY 2013
1Q FY 2012

Quarterly net income(loss) per share

Diluted net income per
share

Yen
Yen
1Q FY 2013(16.52)－
1Q FY 2012
(27.00)－(Note) Despite the issuance of stock acquisition rights, information in connection with diluted quarterly net profit per share is notdisclosed due to quarterly net loss per share.
(2) Financial position
Total assets
1Q FY 2013 (As of March 31, 2013)
FY 2012 (As of December 31, 2012)

Net assets

Millions of yen
6,376
5,502

Equity ratio

Millions of yen
5,766
4,899

Net assets per share
%
89.8
88.6

(Reference) Net assets excluding subscription rights to shares:
1Q FY 2013 (As of March 31, 2013)

5,725 million yen

FY 2012 (As of December 31, 2012)

4,872 million yen

Yen
249.18254.71

2. Dividends

FY 2012FY 2013
FY 2013 (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

English translation

3. Earnings forecasts for FY 2013 (January 1, 2013 to December 31, 2013)
Operatingincome (loss)

Net sales

Full Year

Ordinary
income (loss)(Percentages indicate year-on-year changes.)
Net income (loss)
Net income (loss)
per share

Millions ofyen%Millions ofyen%Millions ofyen%Millions of
yen

%

Yen

1,927

(1.4)

(1,889)-(1,922)-(1,926)-(81.03)(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:

Yes ・ No(b) Changes in accounting polices due to otherreason:Yes(c) Changes in accounting estimates:

Yes ・ No(d) Restatements after error corrections:

Yes ・ NoNo(3) Number of shares outstanding (Common stock)(i) Number of shares outstanding at the end of

1Q FY 2013

22,977,157 shares

FY 2012

19,130,900 shares(ii) Number of shares of treasury stock at theend of the period

1Q FY 201375 shares

FY 201275 shares(iii) Average number of shares during the period(cumulative)

1Q FY 2013

21,392,852 sharesthe period (including treasury stock)

1Q FY 2012

19,130,825 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 1 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, 2013

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 concerning going concern assumption………………………………………………………………………

6(4) Notes concerning significant changes in shareholders’ equity ………………………………….…………………

6(5) Significant subsequent events …………………………………………………………..……………….…………

7

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the first quarter of fiscal year ending December 31, 2013

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 2013 is as follows:(i) Domestic[SyB L-0501 (the generic name: bendamustine hydrochloride, the trade name: TREAKISYM®)]
The Company sells an anticancer drug SyB L-0501 in Japan through the business partner Eisai Co., Ltd. (Eisai) for theindications of refractory/relapsed indolent non-Hodgkin’s lymphoma (NHL) and mantle cell lymphoma (MCL).
The Company has been engaged primarily in the following clinical trials with TREAKISYM® for extended indications.
For the Phase II clinical trials (collaborative trial in Japan and South Korea) of refractory/relapsed aggressive nonHodgkin’s lymphoma, although the Company had completed analysis and evaluation of the clinical trial data, we
temporarily suspended the application for approval of the product we had planned to make in the previous fiscal year, basedon the results of a pre-application meeting with the Pharmaceuticals and Medical Devices Agency (PMDA), and continued
discussions with PMDA.
We completed the enrollment of patients in March 2013 for the Phase II clinical trials for the indications of untreatedindolent non-Hodgkin’s lymphoma and mantle cell lymphoma, as we continuously implemented the Phase II clinical trials
for the indication of refractory/relapsed multiple myeloma.
Our notification of the clinical trial plan for domestic Phase II clinical trials for the indication of chronic lymphocytic
leukemia was accepted in December 2012, and we made preparations for starting the enrollment of patients for the trials.
Furthermore, TREAKISYM® was designated as an orphan drug for the indication of chronic lymphocytic leukemia in June2012.
Moreover, we received a notice of release from the special drug use results survey, which was a condition for theapproval of TREAKISYM®, from the Ministry of Health, Labour and Welfare in March 2013.
[SyB L-1101 (the intravenous form)/C-1101 (the oral form) (the generic name: rigosertib)]
With regard to SyB L-1101 (the intravenous form), an anticancer drug, we worked on the patient enrollment for domestic
Phase I clinical trials for the indication of refractory/relapsed myelodysplastic syndrome (MDS).
As for SyB C-1101, the oral form, we started domestic Phase I clinical trials for the indication of untreated MDS with thefirst patient enrollment conducted in March 2013.
[SyB D-0701]
In January 2013, we completed the Phase II clinical trial of SyB D-0701 (a transdermal antiemetic patch) for theindication of radiotherapy-induced nausea and vomiting. We will conduct detailed analyses of the trial results to investigate
the future direction of development.
(ii) Overseas
Sales of SyB L-0501 are performing well. The drug is sold in Taiwan through InnoPharmax Inc. (Taiwan) and in
Singapore and South Korea through Eisai (local subsidiaries), as we do in Japan.
(iii) Fund procurement
The Company made a resolution on December 27, 2012 to issue the first unsecured convertible bond with stockacquisition rights (total issue price: 1 billion yen) with Whiz Healthcare PE Series 1 Investment Limited Liability
Partnership as the allottee and the 29th warrant (total issue price: 5.1 million yen, total issue price of stocks when issued
through exercising the stock acquisition rights: 500 million yen), with the aim of accelerating development of new drugcandidates and further reinforcing the pipeline. Accordingly, Whiz Healthcare PE Series 1 Investment Limited Liability
Partnership completed payment of 1,005,100 thousand yen to the Company on January 15, 2013.
In January 2013, the 29th series stock option was partially exercised and the total paid-in amount of 199,998 thousand
yen has been received.
(iv) Business results
As a result of the aforementioned developments, net sales totaled 489,016 thousand yen (a year-on-year decrease of
15.8%) for the first quarter of the fiscal year ending December 31, 2013, reflecting primarily the sales of SyB L-0501 in
Japan and Asian countries.

-1-

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the first quarter of fiscal year ending December 31, 2013

Selling, general and administrative expenses totaled 492,009 thousand yen (a year-on-year decrease of 19.2%), including
research and development (“R&D”) expenses of 277,494 thousand yen (a year-on-year decrease of 23.3%) for the accrual of
expenses associated with the clinical trials for multiple indications for SyB L-0501 and clinical trials and preparations for
SyB L-1101, among other things, as well as other selling, general and administrative expenses of 214,515 thousand yen (ayear-on-year decrease of 13.3%).
As a result, we posted operating loss of 341,025 thousand yen for the first three months ended March 31, 2013 (incontrast to operating loss of 480,647 thousand yen for the same period in the previous fiscal year). In addition, recording of
totaling 13,284 thousand yen as non-operating expenses, primarily comprising foreign exchange losses and stock issuancecost, and other factors led to ordinary loss of 352,425 thousand yen (ordinary loss of 515,508 thousand yen for the same
period in the previous fiscal year) and net loss of 353,375 thousand yen (net loss of 516,458 thousand yen for the same
period in the previous fiscal year).
Furthermore, segment information is omitted since the Company operates a single segment of pharmaceutical businessincluding 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, 2013 stood at 6,376,811 thousand yen, an increase of 874,620 thousand yen from theprevious fiscal year end. This was primarily due to an increase of capital stock and capital surplus and the net loss for thethree months period.
Total assets stood at 6,376,811 thousand yen, an increase of 874,620 thousand yen from the previous fiscal year end,
primarily due to an increase of both cash and deposits of 407,151 thousand yen and marketable securities of 501,937
thousand yen arising from fund procurement.
Total liabilities stood at 610,788 thousand yen (in contrast to 602,232 thousand yen as of the previous fiscal year end)
Net assets increased by 866,065 thousand yen from the previous fiscal year end to 5,766,023 thousand yen since each of
capital stock and capital surplus increased by 602,144 thousand yen in spite of a net loss of 353,375 thousand yen. As aresult, the equity ratio increased by 1.2 percentage points to 89.8% from the previous fiscal year end.

(3) Qualitative information concerning earnings forecasts
No revision is made to the earnings forecasts for FY 2013 as of the date of this document.

-2-

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the first quarter of fiscal year ending December 31, 2013

2. Quarterly Financial Statements(1) Balance sheets(Unit: Thousand yen)
FY 20121Q FY 2013

(As of December 31, 2012)(As of March 31, 2013)

AssetsCurrent assets
Cash and deposits
Accounts receivable-trade

4,540,022
148,081

4,947,173
125,498

Marketable securities
Merchandise and finished goods

300,000
164,571

801,937
243,447

Prepaid expenses
Advances paid

98,192
99,03673,786
90,236

Other
Total current assets

70,71817,8655,420,623

6,299,944

2,637

2,589

Noncurrent assets
Property, plant and equipment
Buildings, net
Tools, furniture and fixtures, net

11,084

9,859

Total property, plant and equipment

13,721

12,449SoftwareLease assets

8,324
2,540

7,717
2,378

Total intangible assets

10,864

10,095Investments and other assets
Long-term prepaid expenses

27,64625,352

Lease and guarantee deposits

29,33428,968

Total investments and other assets

56,98054,321Intangible assets

Total noncurrent assets

81,56776,866

5,502,190

6,376,811

Accounts payable-trade
Accounts payable-other329,768
195,833

351,894
188,836

Income taxes payable
Other

15,58857,336

7,994
58,710Total current liabilities

598,527

607,435

1,688

1,505

Other

2,017

1,847

Total noncurrent liabilities

3,705

3,352

602,232

610,788

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, 2013

(Unit: Thousand yen)
FY 20121Q FY 2013

(As of December 31, 2012)(As of March 31, 2013)

Net assets
Shareholders' equity
Capital stock
Capital surplus
Retained earnings
Treasury stock
Total shareholders' equity
Valuation and translation adjustments
Valuation difference on available-for-salesecurities
Total valuation and translation adjustments
Subscription rights to shares
Total net assets
Total liabilities and net assets

6,024,610
5,994,610

6,626,754
6,596,754(7,146,411)(17)(7,499,787)
(17)

－

1,653

－

1,653

4,872,790-4-

5,723,703

27,167

40,667

4,899,957

5,766,023

5,502,190

6,376,811

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the first quarter of fiscal year ending December 31, 2013

(2) Statements of operations (cumulative)(For the first quarter of the fiscal year ending December 31, 2013)(Unit: Thousand yen)
1Q FY 2012

1Q FY 2013

(From January 1, 2012
To March 31, 2012)(From January 1, 2013
To March 31, 2013)

Net sales
Cost of sales
Gross profit
Selling, general and administrative expenses
Operating loss
Non-operating income
Interest income
Interest on securities
Other
Total non-operating income
Non-operating expenses
Interest expenses
Commission fee
Stock issuance cost
Foreign exchange losses
Other
Total non-operating expenses
Ordinary loss
Loss before income taxes
Income taxes-current
Total income taxes
Net loss

580,816

489,016

452,405

338,032

128,410

150,984

609,058

492,009(480,647)(341,025)

533
－

359
102

993

1,883

75

8

2,692
－

2,663
4,484

33,066
18

6,028
100

35,853

13,284(515,508)(352,425)

950

950

459

(515,508)

-5-

1,421

(352,425)

950

950

(516,458)(353,375)

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the first quarter of fiscal year ending December 31, 2013

(3) Notes concerning going concern assumption
None(4) Notes concerning significant changes in shareholders’ equity
Based upon the resolution at the Company’s Board of Directors meeting held on December 27, 2012, the Company issued
the 1st unsecured convertible bond with stock acquisition rights and the 29th series stock option on January 15, 2013 and hasreceived the proceeds in the amount of 1,005,100 thousand yen on the same date.
With regard to the 1st unsecured convertible bond with stock acquisition rights, all rights with face value of 1,000,000
thousand yen have been exercised by February 27, 2013. As for the 29th series stock option, 20 units (26,525 shares per unit)
were exercised on January 25, 2013 and the proceeds of 199,998 thousand yen has been received.
As a result of these primary events, capital stock and capital surplus increased by 602,144 thousand yen to 6,626,754
thousand yen and 6,596,754 thousand yen, respectively, as of March 31 2013.

-6-

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the first quarter of fiscal year ending December 31, 2013(5) Significant subsequent events(a) Cancellation of issuance of the stock option (the stock acquisition right) to the Company’s Directors and employees
At the Board of Directors’ meeting held on April 12, 2013, it was resolved to issue 1,570 units of stock acquisition rights
as a stock option to five (5) Directors and 1,670 units to 71 employees of the Company, based upon the resolution of the
Shareholders’ meeting held on March 28, 2013. However, taking into account such factors as the significant rise in stock priceof the Company, the Board of Directors has decided to cancel the issuance of the stock option to the Company’s Directors andemployees at the meeting held on April 26, 2013 if the fair value of the stock option per unit exceeds 50,955 yen as of theallotment date of the stock option (April 30, 2013). Such fair value of the stock option shall be determined based on the third
party specialist’s valuation using various assumptions including the closing price of the Company’s common stock in theordinary session at JASDAQ on April 30, 2013.
Since the fair value as determined above exceeded 50,955 yen on April 30, 2013, the Company has cancelled the issuanceof the stock option based on the aforementioned resolution of the Board of Directors’ meeting.
(b) Issuance of the stock option (the stock acquisition right) to the Company’s Directors
At the Board of Directors’ meeting held on May 14, 2013, it was resolved to issue 1,170 units of stock acquisition rights asa stock option to 5 Directors of the Company as follows, based upon the resolution of the Shareholders’ meeting held on
March 28, 2013. The stock option was allotted to the relevant Directors on the allotment date of May 29, 2013.
Number of the stock option

1,170 units

Class and number of shares
underlying the stock option

Common stock

Issue price of the stock option

Without consideration

117,000 shares

Paid-in amount per share upon exercise of the stock option shall be the higher ofPaid-in amount upon exercise of thestock option

either (i) the amount calculated by multiplying 1.05 by the average of closing pricesof the Company’s common stock in the ordinary session at Financial Instrument
Exchange on each day of the month preceding the month on the allotment date(rounding up to the nearest one yen) or (ii) the closing price on the allotment date(when no transaction is made on the allotment date, the closing price on the mostrecent day preceding that date).

Period during which the stock
option can be exercised

From May 15, 2015 to May 14, 2023
(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
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(2)

Directors meeting resolves that he/she has resigned or retired amicably.
The person granted (the “Grantee”) shall be able to exercise any part or all ofgranted rights in accordance with the following.
(a) From May 15, 2015 to May 14, 2016, the Grantee may exercise rights up

Terms and conditions for theto a ceiling of one fourth of the stock options granted.

exercise of the stock option(b) From May 15, 2016 to May 14, 2017, the Grantee may exercise rights up
to a ceiling of half of the stock options granted.
(c) From May 15, 2017 to May 14, 2018, the Grantee may exercise rights up
to a ceiling of three quarters of the stock options granted.
(d) From May 15, 2018 to May 14, 2023, the Grantee may exercise rights up
to a ceiling of all stock options granted.
(3)

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

due to the issuance of shares upon
exercise of the stock optionof the stock option shall be half of the maximum amount of paid-in capital increase
and others which is calculated in accordance with Article 17 of the Corporation-7-

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the first quarter of fiscal year ending December 31, 2013

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.

(c) Issuance of the stock option (the stock acquisition right) to the Company’s employees
At the Board of Directors’ meeting held on May 14, 2013, it was resolved to issue 1,245 units of stock acquisition rights asa stock option to 69 employees of the Company as follows, based upon the provisions set forth in Article 236, 238 and 240 ofCompanies Act. The stock option was allotted to the relevant employees on the allotment date of May 29, 2013.
Number of the stock option

1,245 units

Class and number of shares
underlying the stock option

Common stock

Issue price of the stock option

Without consideration

124,500 shares

Paid-in amount per share upon exercise of the stock option shall be the higher of
either (i) the amount calculated by multiplying 1.05 by the average of closing prices
Paid-in amount upon exercise of thestock optionof the Company’s common stock in the ordinary session at Financial Instrument
Exchange on each day of the month preceding the month on the allotment date(rounding up to the nearest one yen) or (ii) the closing price on the allotment date(when no transaction is made on the allotment date, the closing price on the mostrecent day preceding that date).

Period during which the stock option
can be exercised

From May 15, 2015 to May 14, 2023
(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
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)

The person granted (the “Grantee”) shall be able to exercise any part or all ofgranted rights in accordance with the following.
(a) From May 15, 2015 to May 14, 2016, the Grantee may exercise rights up

Terms and conditions for the
exercise of the stock option

to a ceiling of one fourth of the stock options granted.
(b) From May 15, 2016 to May 14, 2017, the Grantee may exercise rights up
to a ceiling of half of the stock options granted.
(c) From May 15, 2017 to May 14, 2018, the Grantee may exercise rights up
to a ceiling of three quarters of the stock options granted.
(d) From May 15, 2018 to May 14, 2023, the Grantee may exercise rights up
to a ceiling of all stock options granted.
(3)

For other terms and conditions, “Stock Option Allotment Agreement” which
will be concluded between the Company and Directors shall be complied with.

Amount of paid-in capital to be increased due to the issuance of shares upon exercise
Paid-in capital amount increased dueto the issuance of shares uponof the stock option shall be half of the maximum amount of paid-in capital increase
and others which is calculated in accordance with Article 17 of the Corporation

exercise of the stock option

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.

-8-