English translation

Summary of Financial Results
For the Second Quarter of Fiscal Year Ending December 31, 2015
[Japanese GAAP] (Non-consolidated)
August 5, 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

Contact Person
Scheduled Date to File
Quarterly Report

Director, Finance & Accounting

Tetsuya Maruyama
Date of dividend
payment (plan)

August 6, 2015

TEL 03(5472)1125－

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 2015 (January 1, 2015 to June 30, 2015)(1) Operating Results (cumulative)(Percentage indicates year-on-year change)
Net Sales

Operating Income (loss) Ordinary Income (loss) Quarterly Net Income (loss)

millions of yen%

millions of yen%

millions of yen%

millions of yen

%

976
975

0.1
20.3

(647)
(646)

－
－

(673)
(713)

－
－

(676)
(715)

－
－

2Q FY 2015
2Q FY 2014

Quarterly Net Income(loss) per share

Diluted Quarterly Net
Income per share

Yen(20.88)(23.35)Yen－－

2Q FY 2015
2Q FY 2014

(2) Financial Position
Total Assets
2Q FY 2015 (as of June 30, 2015)
FY 2014 (as of December 31, 2014)(Reference) Equity:

millions of yen
7,046
7,453

2Q FY 2015 (as of June 30, 2015)
FY 2014 (as of December 31, 2014)

Net Assets

Equity Ratio

millions of yen
6,335
6,963

%
86.4
90.7

6,087 million yen
6,763 million yen

2. Dividends

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
－
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 2015 (January 1, 2015 to December 31, 2015)
Operating
Income (loss)

Net Sales

Full Year(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

1,870

(4.3)

(2,452)－(2,481)－(2,485)－(68.61)(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 ・ 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)

2Q FY 2015

32,390,923 shares

FY 2014

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

2Q FY 201575 shares

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

2Q FY 2015

32,390,848 shares

2Q FY 2014

30,634,182 shares* Status of the quarterly review
Review of quarterly financial statements as required by the Financial Instruments and Exchange Act in the final stage as of thedate 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 3 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, 2015

Index of the attachment
1. Qualitative Information Concerning Quarterly Financial Results …………………………………………………….……

2(1) Qualitative information concerning business results ……………………………………………………………………

2(2) Qualitative information concerning financial position …………………………………………….……………………

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

3

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

4(1) Balance sheets …………………………………………………………………………………………………………..

4(2) Statements of operations (cumulative)…………………………………………………………………………………..

6(3) Quarterly cash flow statements……………………………………………………………………………………………

7(4) Notes on quarterly financial statements …………………………………………………………………………………

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

9(Notes regarding significant changes in shareholders’ equity) ………………………………….………………………

9(Significant subsequent events) …………………………………………………………..……………….………………

9-1-

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the second 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 second quarter of FY 2015 is as follows:(i) Domestic[Anticancer agent 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 its domestic Phase II clinical trial in February, 2014, and is currently preparing the New Drug Application(NDA) for submission in Japan. The Company will apply for approval as soon as the regulatory approval process for theapplication submitted by Astellas Pharma Europe Ltd. is completed in the EU.
Secondly, regarding the indication of chronic lymphocytic leukemia, patient enrollment was completed in October, 2014,
and necessary procedures were undertaken for the domestic Phase II clinical trial. TREAKISYM® was designated as anorphan drug (pharmaceutical for the treatment of rare diseases) for the indication of chronic lymphocytic leukemia in June,
2012. The Company plans to complete the Phase II clinical trial as soon as possible, followed by the submission of a
supplemental NDA.
Thirdly, regarding the additional indication of refractory/relapsed intermediate/high-grade non-Hodgkin’s lymphoma, theCompany’s approach to development is now under consideration.
In addition, the "Evaluation Committee on Unapproved or Off-Labeled Drugs with High Medical Needs," an expert teamassembled by the Ministry of Health, Labour and Welfare in Japan, is currently evaluating the indications of frontline lowgrade non-Hodgkin’s lymphoma, mantle cell lymphoma and refractory/relapsed intermediate/high-grade non-Hodgkin’s
lymphoma.
[SyB L-1101 (intravenous formulation) and SyB C-1101 (oral formulation), generic name: rigosertib]
After having completed patient enrollment in January, 2015, the Company continues to conduct its domestic Phase I
clinical trial for the anticancer agent SyB L-1101 (intravenous formulation, or “IV rigosertib”) in refractory/relapsed higher
risk myelodysplastic syndrome (MDS), a hematological malignancy.
Onconova Therapeutics, Inc. (“Onconova”), the U.S. Licensor, plans to conduct a global Phase III trial for higher risk
MDS patients who do not respond to treatment with hypomethylating agents (HMAs), the current standard of care(“Primary HMA Failure”), with clinical trial sites in more than ten countries worldwide.
The Company is considering its participation in the global clinical trial which is planned to begin in the second half of2015 after completion of the domestic Phase I clinical trial.
As for SyB C-1101 (oral formulation, or “Oral rigosertib”), the Company’s domestic Phase I clinical trial for the target
indication of higher risk MDS was completed in June, 2015. The Company plans to continue clinical trials for thedevelopment of Oral rigosertib in combination with azacitidine for higher risk MDS, as well as for lower risk transfusiondependent MDS, and is considering its participation in the global clinical trial to be conducted by Onconova.
(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 976,194 thousand yen for the second 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 11.6% compared to the second quarter of the previous year while overseas sales were partiallyaffected by inventory adjustments in the previous year. Thus, overall net sales showed a year-on-year increase of 1.7%.
Selling, general and administrative expenses totaled 930,553 thousand yen (a year-on-year increase of 4.2 %), including
research and development (“R&D”) expenses of 403,731 thousand yen (a year-on-year increase of 9.0 %) 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 526,821 thousand yen (a year-on-year increase of 0.7 %).
As a result, an operating loss of 647,968 thousand yen was recognized for the second quarter of fiscal year ending
December 31, 2015 (operating loss of 646,260 thousand yen for the second quarter of the previous fiscal year). In addition,-2-

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

the Company recorded non-operating expenses totaling 34,669 thousand yen primarily comprising foreign exchange loss.
This resulted in an ordinary loss of 673,992 thousand yen (ordinary loss of 713,197 thousand yen for the second quarter ofthe previous fiscal year) and net loss of 676,424 thousand yen (net loss of 715,355 thousand yen for the second 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 June 30, 2015 stood at 7,046,256 thousand yen, a decrease of 407,543 thousand yen from the previous
fiscal year end, which consisted of an increase in merchandise and finished goods of 191,482 thousand yen, and decrease inmarketable securities of 399,616 thousand yen, in cash and deposits of 99,753 thousand yen, in accounts receivable-trade of
22,852 thousand yen, in prepaid expenses of 14,162 thousand yen, and in other current assets of 39,960 thousand yen.
Total liabilities stood at 710,333 thousand yen, an increase of 220,109 thousand yen from the previous fiscal year end,
primarily due to an increase in accounts payable-trade of 268,298 thousand yen and decrease in accounts payable-other of
47,114 thousand yen.
Net assets decreased by 627,653 thousand yen from the previous fiscal year end to 6,335,922 thousand yen primarily due
to a net loss of 676,424 thousand yen.
As a result, the equity ratio decreased by 4.3 points to 86.4% 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.

-3-

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

2Q FY 2015(as of June 30, 2015)

5,692,075
272,656
899,256
244,588
36,69059,84084,981

5,592,321
249,804
499,640
436,070
22,52847,32745,0207,290,088

6,892,713

21,55427,441

21,701
24,131

48,99645,832Intangible assets
Software
Software in progress
Lease assets

62,2732,556
1,243

57,851－
918

Total intangible assets

66,07358,770Investments and other assets
Long-term prepaid expenses
Lease and guarantee deposits

1,351
47,289200
48,73948,641

48,940Total investments and other assets
Total noncurrent assets
Total assets

163,710

153,543

7,453,799

7,046,256

305,996
142,884
21,254574,294
95,76919,363Liabilities
Current liabilities
Accounts payable-trade
Accounts payable-other
Income taxes payable
Other

17,811

19,185

Total current liabilities

487,946

708,613

Provision for retirement benefits
Other

1,634
642

1,427
292

Total noncurrent liabilities

2,276

1,719

490,223

710,333

Noncurrent liabilities

Total liabilities-4-

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the second 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-5-

2Q FY 2015(as of June 30, 2015)

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

8,330,775
8,300,775(10,543,938)(17)

6,764,019

6,087,595

(744)

(360)

(744)

(360)

200,300

248,687

6,963,576

6,335,922

7,453,799

7,046,256

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the second quarter of fiscal year ending December 31, 2015(2) Statements of operations (cumulative)(For the second quarter of the fiscal year ending December 31, 2015)

Net sales
Cost of sales

2Q FY 2014
(from January 1, 2014
to June 30, 2014)
975,345728,216(Unit: thousands of yen)
2Q FY 2015
(from January 1, 2015
to June 30, 2015)
976,194
693,610Gross profit

247,128

282,584

Selling, general and administrative expenses

893,389

930,553

Operating loss

(646,260)(647,968)

7,299
4,470
214

6,919
1,700
24

11,983

8,645

57
4,760
101
74,000
－

7
4,450
160
29,379671

78,91934,669(673,992)

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

(713,197)

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

89

689

89

689

347

1,221

Total extraordinary loss

347

1,221

Loss before income taxes(713,455)(674,524)

Income taxes-current

1,900

1,900

Total income taxes

1,900

1,900

(715,355)(676,424)

Net loss-6-

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the second quarter of fiscal year ending December 31, 2015(3) Quarterly cash flow statements

First six months of Fiscal 2014
(from January 1, 2014
to June 30, 2014)(Unit: thousands of yen)First six months of Fiscal 2015
(from January 1, 2015
to June 30, 2015)(713,455)
4,061
41,855(674,524)
11,71549,076

(112)

(207)

(11,769)
57
63,803
4,760
101
(89)
347
(227,359)(153,489)
11,29649,35019,09554,444
5,571
150,848(119,951)
711
(953)

(8,620)
7
4,190
4,450
160
(689)
1,221
22,852(191,482)
9,711
12,513
3,655
20,5401,151
268,298(34,930)(522)(1,488)(820,873)(502,918)

11,721(57)(1,900)8,434(7)(1,900)(811,100)(496,391)

338,419(1,000,000)
600,000(18,980)(29,600)(41,486)－－
400,000(11,974)
(900)
(432)

216

16,420(151,431)

403,113

Net cash provided by (used in) operating activities
Quarterly (loss) before income taxes
Depreciation
Share-based compensation expenses
Increase (decrease) in provision for retirement
benefits
Interest income
Interest expenses
Foreign exchange losses (gains)
Commission fees
Stock issuance cost
Gain on reversal of stock acquisition rights
Loss on retirement of non-current assets
Decrease (increase) in accounts receivable
Decrease (increase) in inventories
Decrease (increase) in prepaid expenses
Decrease (increase) in advances paid
Decrease (increase) in consumption taxes receivable
Decrease (increase) in current assets-other
Decrease (increase) in long-term prepaid expenses
Increase (decrease) in accounts payable-trade
Increase (decrease) in accounts payable-other
Increase (decrease) in other current liabilities
Other
SubtotalInterest and dividends income received
Interest expenses paid
Income taxes paid
Net cash provided by (used in) operating activities
Net cash provided by (used in) investing activities
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-7-

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

First six months of Fiscal 2014
(from January 1, 2014
to June 30, 2014)(Unit: thousands of yen)First six months of Fiscal 2015
(from January 1, 2015
to June 30, 2015)(101)(1,850)

(340)
－

(344)
(90)

(441)

(2,284)

Net cash provided by (used in) financing activities
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(33,129)(4,190)(996,112)(99,753)

Cash and cash equivalents at the beginning of the period

5,294,137

5,092,075

Cash and cash equivalents at the end of the period

4,298,024

4,992,321-8-

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the second quarter of fiscal year ending December 31, 2015(4) 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)
None to report-9-