English translation

Summary of Financial Results
For the Third Quarter of Fiscal Year Ending December 31, 2015
[Japanese GAAP] (Non-consolidated)
November 6, 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)

November 9, 2015

Supplementary materials for the quarterly financial results:YesNoHolding of quarterly earnings performance review:

Yes

NoTEL 03(5472)1125－(millions of yen – rounded down, unless otherwise stated）
1. Business Results for the Third Quarter of FY 2015 (January 1, 2015 to September 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%

1,332
1,348(1.2)
1.9(987)(966)－－(1,056)(940)－－(1,059)(943)－－

3Q FY 2015
3Q FY 2014

Quarterly Net Income(loss) per share

Diluted Quarterly Net
Income per share

Yen(32.71)(30.80)Yen－－

3Q FY 2015
3Q FY 2014

(Note) Although dilutive shares in issue, diluted net income per share is not stated as net loss was reported for the period.
(2) Financial Position
Total Assets
3Q FY 2015 (as of September 30, 2015)
FY 2014 (as of December 31, 2014)(Reference) Equity:

millions of yen
6,164
7,453

3Q FY 2015 (as of September 30, 2015)
FY 2014 (as of December 31, 2014)

Net Assets
millions of yen
5,981
6,963

Equity Ratio
%
92.5
90.7

5,704 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 dividends forecasts 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 ofyen%

Yen

1,870(4.3)(2,452)－(2,481)－(2,485)－(68.61)

Yes ・ No

(Note) Revisions to earnings forecasts recently announced:

Notes:(1) Application of special accounting treatment inpreparation of quarterly financial reports:

Yes ・ 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)

3Q FY 2015

32,390,923 shares

FY 2014

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

3Q FY 201575 shares

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

3Q FY 2015

32,390,848 shares

3Q FY 2014

30,638,138 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 third quarter of the 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) Quarterly statements of operations …………………………………………………………………………………..…

6Statements of operations (cumulative)…………………………………………………………………………………..

6(3) Notes on quarterly financial statements …………………………………………………………………………………

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

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

7(Significant subsequent events) …………………………………………………………..……………….………………

7-1-SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the third quarter of the 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 third quarter of FY 2015:(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. Netsales 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 first-line 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 supplemental New Drug
Application (sNDA) for submission in Japan by holding a preliminary consultation with the Pharmaceuticals and Medical
Devices Agency (“PMDA”). Regulatory approval in the EU is also underway with an application submitted by Astellas
Pharma Europe Ltd.
Secondly, regarding the indication of chronic lymphocytic leukemia, patient enrollment was completed for the domestic
Phase II clinical trial in October, 2014, and necessary procedures were undertaken for the successful completion of the trial
in October, 2015, after the third quarter of fiscal year ending December 31, 2015. TREAKISYM® was designated as anorphan drug (pharmaceutical for the treatment of rare diseases) for the indication of chronic lymphocytic leukemia in June,
2012. In addition, the “Evaluation Committee on Unapproved or Off-Labeled Drugs with High Medical Needs,” acommittee established by the Ministry of Health, Labour and Welfare (“MHLW”) in Japan, requested the Company tofurther develop TREAKISYM®. Using data from the Phase III clinical trial which has been completed overseas, theCompany plans to file an application for manufacturing and marketing approval during the first quarter of the fiscal year
ending December 31, 2016.
Thirdly, regarding the indication of refractory/relapsed intermediate/high-grade non-Hodgkin’s lymphoma, the Company
continues to discuss the path forward for approval with the PMDA.
[SyB L-1101 (intravenous formulation) and SyB C-1101 (oral formulation), generic name: rigosertib]
After having completed patient enrollment in January, 2015, the Company continued 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 (HR-MDS), a hematological malignancy. The clinical trial was successfullycompleted in October, 2015, after the third quarter of the fiscal year ending December 31, 2015.
Onconova Therapeutics, Inc. (“Onconova”), the U.S. Licensor, is conducting a global Phase III trial, with clinical trialsites in more than ten countries worldwide, for HR-MDS patients who do not respond to treatment with hypomethylating
agents (HMAs) or who relapse after treatment under the current standard of care (“primary HMA failure”).
Given the Company reached an agreement with the PMDA regarding its participation in the global Phase III trial inOctober, 2015, after the third quarter of fiscal year ending December 31, 2015, the Company has announced its decision toparticipate in the global Phase III trial. The Company will proceed with preparations for the trial, which is planned to begin
in the fourth quarter of the fiscal year ending December 2015.
Regarding SyB C-1101 (oral formulation, or “Oral rigosertib”), the Company’s domestic Phase I clinical trial for thetarget indication of HR-MDS was completed in June, 2015. The Company plans to continue with the development of Oralrigosertib in combination with azacitidine for HR-MDS, as well as for lower-risk transfusion-dependent MDS, and its
participation in the global Phase III clinical trial to be conducted by Onconova is under consideration.
[New drug candidate]
In addition to TREAKISYM® and rigosertib, the Company has continued with search and evaluation activities to identify
new drug candidates. In October, 2015, after the third quarter of the fiscal year ending December 31, 2015, the Company
entered into an agreement with Incline Therapeutics, Inc. (the “Incline”), a wholly-owned subsidiary of U.S.-based The
Medicines Company (“MEDCO”), for an exclusive license to develop and commercialize IONSYS® in Japan, a patientcontrolled iontophoretic transdermal system for the short-term management of acute postoperative pain. The Company will
begin preparations for a domestic Phase III trial to test IONSYS® in 2016.
(ii) Overseas
Product sales of SyB L-0501 in South Korea, Taiwan and Singapore grew steadily as planned.

-2-

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the third quarter of the fiscal year ending December 31, 2015(iii) Business results
As a result of the above, net sales totaled 1,332,388 thousand yen for the third quarter of the fiscal year ending December
31, 2015, primarily reflecting product sales of SyB L-0501 in Japan and overseas markets. Although net domestic sales ofTREAKISYM® increased by 6.1% compared to the third quarter of the previous year, overall net sales showed a year-onyear decrease of 1.2% since overseas sales were partially affected by inventory adjustments in the previous year.
Selling, general and administrative expenses totaled 1,382,780 thousand yen (a year-on-year increase of 4.7 %),including research and development (“R&D”) expenses of 597,989 thousand yen (a year-on-year increase of 9.7 %)primarily due to expenses associated with (i) clinical trials for various indications and preparations regarding applications for
SyB L-0501, and (ii) clinical trials and preparations regarding the next phase of clinical trials for SyB L-1101 and SyB C1101, as well as other selling, general and administrative expenses of 784,791 thousand yen (a year-on-year increase of1.3 %).
As a result, an operating loss of 987,692 thousand yen was recognized for the third quarter of fiscal year ending
December 31, 2015 (operating loss of 966,650 thousand yen for the third quarter of the previous fiscal year). In addition, theCompany recorded non-operating expenses totaling 81,697 thousand yen, primarily comprising foreign exchange loss. This
resulted in an ordinary loss of 1,056,043 thousand yen (ordinary loss of 940,772 thousand yen for the third quarter of theprevious fiscal year) and net loss of 1,059,425 thousand yen (net loss of 943,652 thousand yen for the third quarter of theprevious fiscal year).
Segment information has been omitted as the Company operates within a single segment of the pharmaceutical industry
which includes the development and commercialization of drugs, manufacturing, marketing and other related activities.
(2) Qualitative information concerning financial position
Total assets as of September 30, 2015 stood at 6,164,412 thousand yen, a decrease of 1,289,386 thousand yen from theprevious fiscal year end, which consisted of an increase in advances paid of 12,018 thousand yen, and decreases in cash anddeposits of 526,891 thousand yen, in marketable securities of 399,426 thousand yen, in accounts receivable-trade of 272,656
thousand yen, in merchandise and finished goods of 24,755 thousand yen, and in other current assets of 69,164 thousandyen.
Total liabilities stood at 182,580 thousand yen, a decrease of 307,643 thousand yen from the previous fiscal year end,
primarily due to decreases in accounts payable-trade of 282,484 thousand yen and in income taxes payable of 16,753
thousand yen.
Net assets decreased by 981,743 thousand yen from the previous fiscal year end to 5,981,832 thousand yen, primarily due
to a net loss of 1,059,425 thousand yen.
As a result, the equity ratio increased by 1.8 points to 92.5% 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.

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

2. Quarterly Financial Statements(1) Balance sheets(Unit: thousands of yen)
FY 2014(as of December 31, 2014)

3Q FY 2015(as of September 30, 2015)

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

5,165,183－

7,290,088

6,006,829

21,55427,441

21,20532,599AssetsCurrent 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

499,830
219,833
34,306
71,85915,81648,99653,804

Intangible assets
Software
Software in progress
Lease assets

62,273
2,556
1,243

54,346－

Total intangible assets

66,073

55,103

Investments and other assets
Long-term prepaid expenses
Lease and guarantee deposits

1,351
47,289133
48,542

Total investments and other assets
Total noncurrent assets
Total assets

756

48,641

48,675

163,710

157,583

7,453,799

6,164,412

305,996
142,884
21,254

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

17,811

23,511
138,441
4,501
14,529Total current liabilities

487,946

180,984

Provision for retirement benefits
Other

1,634
642

1,478
117

Total noncurrent liabilities

2,276

1,595

490,223

182,580

Noncurrent liabilities

Total liabilities-4-SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the third quarter of the fiscal year ending December 31, 2015

(Unit: thousands of yen)
FY 2014(as of December 31, 2014)

3Q FY 2015(as of September 30, 2015)

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

8,330,775
8,300,775

Net assets
Shareholders' equity
Common stock
Capital surplus
Retained earnings
Treasury stock

6,764,019(10,926,939)(17)
5,704,594

Valuation and translation adjustments
Unrealized holding gain (loss) on securities

(744)

(170)

Total valuation and translation adjustments

(744)

(170)

Total shareholders' equity

Stock acquisition rights
Total net assets
Total liabilities and net assets-5-200,300

277,408

6,963,576

5,981,832

7,453,799

6,164,412

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the third quarter of the fiscal year ending December 31, 2015(2) Statements of operations (cumulative)(For the third quarter of the fiscal year ending December 31, 2015)(Unit: thousands of yen)
3Q FY 2015
(from January 1, 2015
to September 30, 2015)

Net sales
Cost of sales

3Q FY 2014
(from January 1, 2014
to September 30, 2014)
1,348,206
994,719

Gross profit

353,487

395,087

Selling, general and administrative expenses

1,320,137

1,382,780

Operating loss

(966,650)(987,692)

11,797
6,612
1,116
13,635
214

9,730
2,519
1,072－

33,375

13,347

63
7,180
254
－

Non-operating income
Interest income
Interest on securities
Dividend income
Foreign exchange gains
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
Extraordinary income
Gain on reversal of stock acquisition rights
Total extraordinary income
Extraordinary loss
Loss on retirement of non-current assets

1,332,388
937,300

24－

116,713
160
74,142
671

7,498

81,697(940,772)(1,056,043)

317

689

317

689

347

1,221

Total extraordinary loss

347

1,221

Loss before income taxes(940,802)(1,056,575)

Income taxes-current

2,850

2,850

Total income taxes

2,850

2,850

(943,652)(1,059,425)

Net loss-6-

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the third quarter of the 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)
No significant changes in shareholders’ equity since December 31, 2014.
(Significant subsequent events)
Conclusion of a license agreement
On October 2, 2015, the Company entered into an agreement with Incline Therapeutics, Inc. (the “Incline”), a wholly-owned
subsidiary of U.S.-based The Medicines Company (“MEDCO”), for an exclusive license to develop and commercialize
IONSYS® in Japan, a patient-controlled iontophoretic transdermal system for the short-term management of acutepostoperative pain. Based on the agreement, the Company will make the following payments to the Incline: (i) an upfront
payment, (ii) milestone payments in accordance with development progress and (iii) after launch, the Company will also payroyalties, as well as commercial milestone payments on achievement of annual sales.
The Company will begin preparations for a domestic Phase III trial to test IONSYS® in 2016.

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