English translation

Summary of Financial Results
for the First Quarter of Fiscal Year Ending December 31, 2015
[Japanese GAAP] (Non-consolidated)
May 7, 2015
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

Chief Financial Officer

Contact Person
Scheduled Date to File
Quarterly Report

Kazuyasu Hakata
Date of dividend
payment (plan)

May 8, 2015

Supplementary materials for quarterly financial results:

Yes

No

Holding of quarterly earnings performance review:

Yes

No

TEL 03 (5472) 1125－

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

1. Business Results for the First Quarter of FY 2015 (January 1, 2015 to March 31, 2015)(1) Operating Results (cumulative)(Percentage indicates year-on-year change)
Operating Income
Ordinary Income
Quarterly Net Income
Net Sales(loss)(loss)(loss)
millions of yen%

millions of yen%

millions of yen%

millions of yen

%

408
173

135.0
(64.5)

(332)
(415)

－
－

(418)
(453)

－
－

(420)
(454)

－
－

1Q FY 2015
1Q FY 2014

Quarterly Net Income(loss) per share

Diluted Quarterly Net
Income per share

Yen(12.98)(14.85)Yen－－

1Q FY 2015
1Q FY 2014

(Note) Diluted quarterly net income per share not stated above due to quarterly net loss per share, despite the potential dilution of shares.

(2) Financial Position

1Q FY 2015 (as of March 31, 2015)
FY 2014 (as of December 31, 2014)(Reference) Equity:

Total Assets

Net Assets

millions of yen
7,017
7,453

millions of yen
6,566
6,963

1Q FY 2015 (as of March 31, 2015)
FY 2014 (as of December 31, 2014)

Equity Ratio
%
90.4
90.7

6,342 million yen
6,763 million yen

2. Dividend

FY 2014
FY 2015
FY 2015 (Forecast)

1st quarter
Yen－－

Annual Dividend per Share
2nd quarter3rd quarter
Fiscal Year End
Yen
Yen
Yen
0.00
－
0.00
0.00

(Note) Revision of dividend forecasts recently announced:－
Yes ・ No

0.00

Full year
Yen
0.00
0.00

3. Earnings Forecast for FY 2015 (January 1, 2015 to December 31, 2015)(Percentage indicates year-on-year change)

Operating
Income (loss)

Net Sales
millions ofyenFull Year

1,870

%

millions of
yen

(4.3)

(2,452)

Ordinary
Income (loss)%

millions ofyen－

preparation of quarterly financial reports:%

millions ofyen－

Yes ・ No

(Note) Revision of earnings forecasts recently announced:

Notes:(1) Application of special accounting treatment in(2,481)Net Income (loss)(2,485)Net Income (loss)
per share

%

Yen

－

(68.61)

Yes ・ No

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

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

Yes ・ No(d) Restatements after error correction:

Yes ・ No

(3) Number of shares outstanding (common stock)(i) Number of shares outstanding at the end of
the period (including treasury stock)

1Q FY 2015

32,390,923 shares

FY 2014

32,390,923 shares(ii) Number of shares of treasury stock at theend of the period

1Q FY 201575 shares

FY 201475 shares(iii) Average number of shares during the period(cumulative)

1Q FY 2015

32,390,848 shares

1Q FY 2014

30,634,182 shares* Status of quarterly review
The review of quarterly financial statements as required by the Financial Instruments and Exchange Act in the final stage as ofthe date of this disclosure document.
* Explanation regarding the appropriate use of earnings forecasts and other matters
All forecasts presented in this document, including earnings forecasts, are based on the information currently available tomanagement and on assumptions judged to be reasonable. Actual results may differ substantially from these forecasts due tovarious factors. Regarding such assumptions on which the Company’s earnings forecasts are based and their usage, please refer
to “1. Qualitative Information Concerning Quarterly Financial Results, and (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, 2015

Index of 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) Statement of operations (cumulative)…………………………………………………………………………………..

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

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

6(Notes regarding 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, 2015

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 2015 is as follows:(i) Domestic[SyB L-0501 (generic name: bendamustine hydrochloride, trade name: TREAKISYM®)]
The Company markets the anticancer agent TREAKISYM® in Japan through its business partner, Eisai Co., Ltd.
(“Eisai”), for the indications of refractory/relapsed low-grade non-Hodgkin’s lymphoma and mantle cell lymphoma. Net
sales through Eisai increased as expected.
Aiming to maximize the product value of TREAKISYM®, the Company continues to pursue three additional indications.
Firstly, regarding the indications of frontline low-grade non-Hodgkin’s lymphoma and mantle cell lymphoma, the Company
completed the Phase II clinical trial in February, 2014, and is currently preparing the application to be submitted formarketing approval. In the EU, Astellas Pharma Europe Ltd. has already completed the application process for regulatory
approval. Considering this review process toward securing marketing approval in Europe, the Company plans to file thesupplemental NDA in Japan;
Secondly, regarding the indication of chronic lymphocytic leukemia, patient enrollment for the Phase II clinical trial wascompleted in October, 2014, and necessary procedures followed. The Company plans to complete the clinical trial as soon
as possible followed by submission of the supplemental NDA. TREAKISYM® was designated as an orphan drug
(pharmaceutical for treatment of rare diseases) for the indication of chronic lymphocytic leukemia in June, 2012.
Thirdly, regarding the additional indication of refractory/relapsed intermediate/high-grade non-Hodgkin’s lymphoma, theCompany’s approach to development is being considered.
[SyB L-1101 (intravenous formulation) and SyB C-1101 (oral formulation), generic name: rigosertib]
The domestic Phase I clinical trial of anticancer agent SyB L-1101 (intravenous formulation, or “IV rigosertib”) for theindication of refractory/relapsed higher risk myelodysplastic syndrome (MDS), a hematological malignancy, is underway.
Patient enrollment was completed in January, 2015.
In February, 2014, Onconova Therapeutics, Inc. (“Onconova”), the U.S. Licensor, announced the results from its Phase
III ONTIME trial of IV rigosertib conducted at clinical trial sites in Europe and the U.S. Although treatment with IV
rigosertib plus best supportive care (BSC) did not demonstrate a statistically significant improvement in median overall
survival when compared to BSC only, post-hoc analysis demonstrated a statistically significant increase in median overall
survival in the subset of patients who had progressed on or failed previous treatment with hypomethylating agents (HMAs)(i.e., had not responded to HMAs), thus demonstrating potential activity of rigosertib in these MDS patients. Onconova
continues to discuss with the U.S. and European regulatory agencies the possibility of marketing approval based on top-line
results of the Phase III ONTIME trial. These discussions have consequently led Onconova to focus its development effortson the unmet medical need of patients who do not respond to treatment with HMAs, the current standard of care (“Primary
HMA Failure”). Onconova has announced its future development plan for Primary HMA Failures.
The Company will complete phase 1 of its development program for IV rigosertib in higher risk MDS in Japan. Based on
Onconova’s development plan in the US and Europe, the Company will consider the future development of rigosertib inJapan.
As for SyB C-1101 (oral formulation, or “Oral rigosertib”), the Phase I clinical trial for the target indication of higher risk
MDS is also underway. With the completion of patient enrollment in August, 2014, the Company continues to meet
regulatory requirements toward completion of its development program for Oral rigosertib in Japan. The Company plans tocomplete clinical trials as soon as possible, and develop Oral rigosertib in combination with azacitidine for higher risk MDS
as well as for transfusion-dependent lower risk MDS.
(ii) Overseas
Product sales of SyB L-0501 in South Korea, Taiwan and Singapore grew steadily as planned.
(iii) Business results
As a result of the above, net sales totaled 408,221 thousand yen for the first quarter of fiscal year ending December 31,
2015, primarily reflecting product sales of SyB L-0501 in Japan and overseas markets. Net domestic sales of
TREAKISYM® increased by 2.1 times compared to the first quarter of the previous year due to adjustments in inventory
levels in the previous year. Thus, net sales showed a year-on-year increase of 135.0%.
Selling, general and administrative expenses totaled 452,711 thousand yen (a year-on-year increase of 1.1%), including-1-

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the first quarter of fiscal year ending December 31, 2015

research and development (“R&D”) expenses of 206,178 thousand yen (a year-on-year increase of 15.2%) primarily due to
expenses associated with clinical trials for SyB L-0501, SyB L-1101 and SyB C-1101, and other selling, general andadministrative expenses of 246,532 thousand yen (a year-on-year decrease of 8.3 %).
As a result, an operating loss of 332,295 thousand yen was recognized for the first quarter of fiscal year ending
December 31, 2015 (operating loss of 415,544 thousand yen for the first quarter of the previous fiscal year). In addition, theCompany recorded non-operating expenses totaling 91,460 thousand yen primarily comprising foreign exchange loss. This
resulted in an ordinary loss of 418,875 thousand yen (ordinary loss of 453,905 thousand yen for the first quarter of theprevious fiscal year) and net loss of 420,496 thousand yen (net loss of 454,855 thousand yen for the first quarter of theprevious fiscal year).
Segment information has been omitted since the Company operates within a single segment of the pharmaceuticalindustry which includes the development and commercialization of drugs, manufacturing, marketing and other related
activities.
(2) Qualitative information concerning financial position
Total assets as of March 31, 2015 stood at 7,017,314 thousand yen, a decrease of 436,484 thousand yen from the previous
fiscal year end, which consisted of an increase in cash and deposits of 288,840 thousand yen, and decrease in marketablesecurities of 399,826 thousand yen, in accounts receivable-trade of 231,986 thousand yen, in merchandise and finishedgoods of 15,194 thousand yen, and in other current assets of 65,152 thousand yen.
Total liabilities stood at 450,941 thousand yen, a decrease of 39,281 thousand yen from the previous fiscal year end,
primarily due to an increase in other current liabilities of 39,249 thousand yen, and decrease in accounts payable-trade of
43,647 thousand yen and accounts payable-other of 23,216 thousand yen.
Net assets decreased by 397,202 thousand yen from the previous fiscal year end to 6,566,373 thousand yen primarily due
to a net loss of 420,496 thousand yen for the first quarter.
As a result, the equity ratio decreased by 0.3 percentage points to 90.4% from the previous fiscal year end.
(3) Qualitative information concerning earnings forecasts
No revision was made to the earnings forecasts for FY 2015 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, 2015

2. Quarterly Financial Statements(1) Balance sheets(Unit: thousands of yen)

FY 2014(as of December 31, 2014)
AssetsCurrent assets
Cash and deposits
Accounts receivable-tradeMarketable securities
Merchandise and finished goods
Prepaid expenses
Advances paid
Other
Total current assets
Noncurrent assets
Property, plant and equipment
Buildings, net
Tools, furniture and fixtures, net
Total property, plant and equipment

1Q FY 2015(as of March 31, 2015)

5,692,075
272,656
899,256
244,588
36,69059,84084,9815,980,916
40,669499,430
229,394
36,91550,666
19,8287,290,088

6,857,819

21,55427,441

22,19825,044

48,99647,242Intangible assets
Software
Software in progress
Lease assets

62,2732,556
1,243

61,857－
1,081

Total intangible assets

66,07362,938Investments and other assets
Long-term prepaid expenses
Lease and guarantee deposits

1,351
47,289267
49,047

48,641

49,314

Total investments and other assets
Total noncurrent assets
Total assets

163,710

159,495

7,453,799

7,017,314

305,996
142,884
21,254

262,348
119,667
9,699

Liabilities
Current liabilities
Accounts payable-trade
Accounts payable-other
Income taxes payable
Other

17,811

57,060Total current liabilities

487,946448,776

Noncurrent liabilities
Provision for retirement benefits
Other

1,634
642

1,697
468

Total noncurrent liabilities

2,276

2,165

490,223450,941

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, 2015

(Unit: thousands of yen)

FY 2014(as of December 31, 2014)
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
Stock acquisition rights
Total net assets
Total liabilities and net assets-4-

1Q FY 2015(as of March 31, 2015)

8,330,775
8,300,775(9,867,514)(17)

8,330,775
8,300,775(10,288,010)(17)

6,764,019

6,343,523

(744)

(570)

(744)

(570)

200,300

223,420

6,963,576

6,566,373

7,453,799

7,017,314

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the first quarter of fiscal year ending December 31, 2015(2) Statement of operations (cumulative)(For the first quarter of the fiscal year ending December 31, 2015)(Unit: thousands of yen)

Net sales
Cost of sales

1Q FY 2014
(From January 1, 2014
To March 31, 2014)
173,681
141,322

1Q FY 2015
(From January 1, 2015
To March 31, 2015)
408,221287,805

Gross profit

32,359120,416

Selling, general and administrative expenses

447,904

452,711

Operating loss

(415,544)(332,295)

3,692
2,345
197

3,967
895
18

6,235

4,880

51
2,367
101
42,076
－

4
2,213
160
88,501581

44,596

91,460(453,905)(418,875)

－

366

－

366

－

1,037

Non-operating income
Interest income
Interest on securities
Other
Total non-operating income
Non-operating expenses
Interest expenses
Commission fees
Stock issuance costs
Foreign exchange loss
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

－

1,037

(453,905)(419,546)

Income taxes-current

950

950

Total income taxes

950

950

(454,855)(420,496)

Total extraordinary loss
Loss before income tax

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, 2015

(3) Notes on quarterly financial statements(Notes regarding going concern assumption)
None to report.
(Notes regarding significant changes in shareholders’ equity)
None to report.
(Significant subsequent events)(a) Issuance of stock acquisition rights (stock option) to the Company’s Directors
At the Board of Directors’ meeting held on March 26, 2015, a resolution was passed regarding the issuance of stockacquisition rights as a stock option to six (6) Directors of the Company as follows. The stock option was allotted to relevant
Directors on the allotment date of April 10, 2015.
Number of stock option

2,042 units

Class and number of shares
underlying the stock option

Common stock 204,200 shares

Issue price/ Total issue priceof the stock option

Issue priceTotal issue priceAmount to be paid in for the stock
option30,600 yen
62,485,200 yen

Amount to be paid in: 306 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 of 1 yen

Period during which the stock
option can be exercised

From March 27, 2018 to March 26, 2025

Terms and conditions for exerciseof the stock option

Paid-in capital amount increased
due to the issuance of shares upon
exercise of the stock option

Matters concerning transfer of thestock option(1) The person allotted shall be a director or an employee of the Company or its
affiliate at the time of exercise. However, the terms and conditions for the
exercise of stock option described herein shall not apply when: (a) the person
resigns from the Company or its affiliate due to the expiry of her/his term, (b)the person retires from the Company or its affiliate due to compulsory
retirement age or (c) the Board of Directors resolves that he/she has resigned or
retired on an amicable basis.
(2) For other terms and conditions, the Company and Directors shall comply withthe “Stock Option Allotment Agreement” concluded between the parties.
Increase in the amount of paid-in capital due to the issuance of shares upon theexercise of stock option shall be half of the maximum amount of paid-in capitalincrease 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.
Requires approval at 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, 2015(b) Issuance of stock acquisition rights (stock option) to the Company’s employees
At the Board of Directors’ meeting held on March 26, 2015, a resolution was passed regarding the issuance of stockacquisition rights as a stock option to 61 Company employees as follows. The stock option was allotted to relevant employeeson the allotment date of April 10, 2015.
Number of stock option

3,120 units

Class and number of shares
underlying the stock option

Common stock

Issue price/ Total issue priceof the stock option

Issue priceTotal issue priceAmount to be pain in for the stock
option312,000 shares
30,600 yen
95,472,000 yen

Amount to be paid in: 306 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 of 1 yen

Period during which the stock option
can be exercised

From March 27, 2018 to March 26, 2025
1)

Terms and conditions for exerciseof the stock option

Paid-in capital amount increased dueto the issuance of shares upon
exercise of the stock option
Matters concerning transfer of thestock option

The person allotted shall be a director or employee of the Company or its
affiliate at the time of exercise. However, the terms and conditions for the
exercise of stock option described herein shall not apply when: (a) the person
resigns from the Company or its affiliate due to the expiry of her/his term, (b)the person has retires from the Company or its affiliate due to compulsory
retirement age or (c) the Board of Directors resolves that he/she has resigned or
retired on an amicable basis.
(2) For other terms and conditions, the Company and Company employees shallcomply with the “Stock Option Allotment Agreement” concluded between theparties.
Increase in the amount of paid-in capital due to the issuance of shares upon theexercise of stock option shall be half of the maximum amount of paid-in capitalincrease 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.
Requires approval at the Board of Directors’ meeting.

-7-