Financial Results for the Third Quarter of Fiscal Year Ending December 31, 2012
[Japan GAAP] (Non-consolidated)
November 9, 2012
Company name:Securities code:

SymBio Pharmaceuticals Limited
4582

Listing: Osaka Securities Exchange
URL http://www.symbiopharma.com/

Representative:

Representative Director,
President and Chief Executive Officer

Fuminori Yoshida

Inquiries:

Director, Managing Officer,
Chief Financial Officer

Hiroki Maekawa

TEL +81-3-5472-1125

Scheduled date of securities
report submission:

November 12, 2012

Scheduled date ofdividend payment:―

Supplementary materials for the financial statements:

No

Presentation to explain for the financial statements:

No(Million yen – rounded down, unless otherwise stated)

1. Business Results for the Third Quarter of Fiscal 2012 (January 1, 2012 to September 30, 2012)(1) Business results (cumulative)(Percentage figures represent changes from the same quarter of the previous fiscal year)
Net sales

Operating profit

Ordinary profit

Quarterly net profit

Million yen%

Million yen%

Million yen%

Million ye

%

1,518
1,306

16.2

-1,238-1,757－-1,256-1,766－-1,259-1,775－

3rd Quarter Fiscal 2012
3rd Quarter Fiscal 2011－－

Quarterly net profit per
share

Diluted quarterly net
profit per share

Yen-65.84Yen

3rd Quarter Fiscal 2012
3rd Quarter Fiscal 2011-131.65

－

－

－

－

(Notes) 1. 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. As the Company started to compile quarterly financial statements in the first quarter of Fiscal 2011, the changes from thesame quarter of the previous fiscal year are not disclosed for the second quarter of Fiscal 2011.
(2) Financial position
Total assets
3rd Quarter Fiscal 2012
Fiscal 2011
(Reference) Shareholders’ equity

Net assets

Equity ratio

Million yen
5,645Million yen
5,364

%
94.7

7,256

6,605

91.0

3rd Quarter Fiscal 2012

5,346 million yen

Fiscal 2011

6,605 million yen

2. Dividends
Annual dividend per share

Fiscal 2011
Fiscal 2012
Fiscal 2012
(forecast)

1st quarter end

2nd quarter end

3rd quarter end

Fiscal year end

Yen
－
－

Yen
0.00
0.00

Yen
－
－

Yen
0.00

Yen
0.00

0.00

0.00

(Note) Revision of forecast of dividends during this quarter:

No

Full year

3. Forecast of Financial Results for Fiscal 2012 (January 1, 2012 to December 31, 2012)(Percentage figures represent changes from the previous fiscal year)
Net sales
Full year

Million yen
1,966Operating profit% Million yen
4.4-1,844

Ordinary profit% Million yen－-1,858Net profit% Million yen－-1,862

Net profit per share%－

Yen-97.33(Note) Revision of forecast of financial results during this quarter: Yes* Explanatory notes(1) Special accounting treatments for quarterly financial

Nostatements:(2) Changes in accounting policies and estimates and retrospective corrections(i) Changes in accounting policies due to revisions ofNoaccounting standards:(ii) Changes in accounting policies other than those
noted in 1.:No(iii) Changes in accounting estimates:No(iv) Retrospective corrections:No(3) Number of issued shares (common shares)
(i)
(ii)

Number of issued shares at the end of period

3rd Quarter(including treasury shares)

Fiscal 2012

Number of treasury shares at the end of

3rd Quarter

periodFiscal 2012(iii) Average number of shares during the period(cumulative quarterly periods)

3rd Quarter
Fiscal 2012

19,130,900sharesFiscal 2011

19,130,900shares

75sharesFiscal 2011

75shares19,130,825shares

3rd Quarter
Fiscal 2011

13,483,900shares* Quarterly review procedures
Review procedure for quarterly financial statements is underway based on Financial Instruments and Exchange Act at the timingof this disclosure.
* Information regarding proper use of financial forecast and other important matters
Any forward-looking statements in this material including forecast of financial results are estimates based on information
available at the time and certain assumptions that the management believes reasonable. Actual results may differ substantiallyfrom such forecasts due to various factors. Please refer to “(3) Forecast of financial results” in “1. Management’s Discussion andAnalysis on the Quarterly Financial Results” on page 2 in the attachment to this quarterly business report for the assumptions forforecast of financial results and notes for its proper use.

○Index of the attachment
1. Management’s Discussion and Analysis on the Quarterly Financial Results .........................................................................

1(1) Business results analysis ...................................................................................................................................................

1(2) Financial position analysis ................................................................................................................................................

2(3) Forecast of financial results ..............................................................................................................................................

2

2. Other Summary Information (Explanatory Notes) ..................................................................................................................

2(1) Additional information ......................................................................................................................................................

2

3. Quarterly Financial Statements ...............................................................................................................................................

3(1) Quarterly balance sheets ...................................................................................................................................................

3(2) Quarterly income statement ..............................................................................................................................................

5(Nine months ended September 30) ............................................................................................................................

5(3) Explanatory note regarding the assumption of the Company as going concern ................................................................

6(4) Explanatory note regarding significant fluctuation in shareholders’ equity ......................................................................

6(5) Important subsequent events .............................................................................................................................................

6

SymBio Pharmaceuticals Limited (4582) － Financial Results for the Third Quarter of Fiscal Year Ending December 31, 2012
[Japan GAAP] (Non-consolidated)

1. Management’s Discussion and Analysis on the Quarterly Financial Results(1) Business results analysis
The Company’s business progressed during the first six months of Fiscal 2012 as follows:
1. Domestic
In Japan, the Company sells an anticancer drug SyB L-0501 (the generic name: bendamustine hydrochloride, the trade
name: TREAKISYM®) through the business partner Eisai Co., Ltd. (hereinafter “Eisai”) for the indications ofrelapsed/refractory indolent non-Hodgkin’s lymphoma (NHL) and mantle cell lymphoma (MCL) since December 2010.
Three different series of clinical trials are underway for TREAKISYM® at present for multiple extended indications. The
registration of trial cases was completed last year for Phase II clinical trials (collaborative trials in Japan and South Korea)
for the indication of relapsed/refractory aggressive non-Hodgkin’s lymphoma and we performed analyses and evaluations ofdata from clinical trials and consulted with the Pharmaceuticals and Medical Devices Agency (hereinafter “the Agency”) in
April 2012 prior to the application for approval.
However, we received the Agency’s comment that the data we had obtained were regarded insufficient for the application
for approval at that point in time. We decided to postpone the application for approval originally planned for the current
fiscal year respecting the Agency’s comment.
In Phase II clinical trials under discussion, we conducted trials in treated patients with relapsed/refractory aggressive nonHodgkin’s lymphoma at a total of 25 facilities in Japan and South Korea for the purpose of assessing the efficacy and safetyof SyB L-0501 in combination with rituximab. 63 cases were registered in these trials, of which 59 cases were analyzed. The
results showed high efficacy with the overall response rate (ORR) of 62.7％ and the complete response (CR) rate of 37.3％.
The median progression-free survival (PFS) was 200 days, suggesting the possibility of improving recuperation for patientswith relapsed/refractory non-Hodgkin’s lymphoma. Side-effects were clinically controllable and the therapy was applicableto elderly patients.
Detailed results of the trials were presented by Dr. Michinori Ogura from Nagoya Daini Red Cross Hospital at the annual
meeting of the American Society of Clinical Oncology (ASCO) held in Chicago in June 2012.
Results of the trial were also presented by a few other doctors, including Dr. Kensei Tobinai, from National Cancer Center
Central Hospital, at the 74th Annual Meeting of the Japanese Society of Hematology held in October, 2012.
We will decide on the future development plan discussing with the business partner Eisai.
Patient enrollment in the Phase II trial for untreated indolent non-Hodgkin’s lymphoma and mantle cell lymphoma, and in
the Phase II trial for relapsed/refractory multiple myeloma achieved 66 out of 67 and 16 out of 44 target patients,
respectively, as of September 30, 2012.
As for an anticancer drug SyB L-1101 (the intravenous form, the generic name: rigosertib), the application for domestic
Phase I clinical trials in Japan was accepted in March 2012 for the indication of relapsed/refractory myelodysplastic
syndrome (MDS), a hematologic cancer. The first series of patient enrollment was done in June 2012 and we initiateddomestic Phase I clinical trials.
In September, 2012, Onconova Therapeutics, Inc. (hereinafter “Onconova”) announced that they haveentered into a license agreement with Baxter International Inc. for the European right to rigosertib. With this alignment,
we expect commercialization of rigosertib in the US and Europe to accelerate and increase the possibility of NDA approval /launch of rigosertib in our licensed territories, Japan and Korea. where we have the exclusive right to develop andcommercialize rigosertib using data generated in the overseas..
Patient enrollment for the Phase II clinical trial of SyB D-0701, a transdermal antiemetic patch indicated for radiotherapyinduced nausea and vomiting (RINV), is ongoing with 181 out of 189 target patients enrolled as of September, 2012 (patient
enrollment to be completed in October, 2012.
2. Overseas
The business partner InnoPharmax Inc. (Taiwan) started to sell SyB L-0501 in Taiwan in February 2012. The sales wereclose to the plan in Singapore and South Korea, where we sell the product through Eisai as in Japan.

－

1

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SymBio Pharmaceuticals Limited (4582) － Financial Results for the Third Quarter of Fiscal Year Ending December 31, 2012
[Japan GAAP] (Non-consolidated)

3. Business results
As a result of aforementioned developments, net sales totaled 1,518,446 thousand yen (an increase by 16.2% from the same
period of the previous fiscal year) in the first nine months of the current fiscal year due to the product sales of SyB L-0501
in Japan and Asian countries.
Selling, general and administrative expenses totaled 1,723,580 thousand yen (an decrease by 20.7% from the same period of
the previous fiscal year), which comprised research and development cost of 1,062,048 thousand yen (an decrease by 33.5%
from the same period of the previous fiscal year) for clinical trials of SyB L-0501 for multiple indications, clinical trials of
SyB D-0701, and preparations for clinical trials of SyB L-1101 as well as selling, general and administrative expenses of661,531 thousand yen (an increase by 15.0% from the same period of the previous fiscal year).
As a result, we posed operating loss of 1,238,704 thousand yen in the first nine months of the current fiscal year (comparedto operating loss of 1,757,759 thousand yen in the same period of the previous fiscal year). Non-operating expenses of
23,600 thousand yen were recorded mainly due to foreign exchange loss, resulting in ordinary loss of 1,256,757 thousand
yen and net quarterly loss of 1,259,647 thousand yen (compared to losses of 1,766,967 and 1,775,148 thousand yen in thesame period of the previous fiscal year, respectively).
Segment information is not disclosed as our business consists of a single line of business, namely drug research anddevelopment, manufacture and sales, and other related activities.

(2) Financial position analysis
Total assets stood at 5,645,325 thousand yen at the end of the third quarter of the current fiscal year, a decrease of 1,610,768
thousand yen from the previous fiscal year end. Current assets stood at 5,569,867 thousand yen, a decrease of 1,608,524
thousand yen from the previous fiscal year end, reflecting a decrease of cash and deposits by 1,689,693 thousand yen due
mainly to expenditures for research and development costs and selling, general and administrative expenses, while marketablesecurities increased by 300,666 thousand yen. Fixed assets decreased to 75,457 thousand yen by 2,244 thousand yen from theprevious fiscal year end.
Liabilities stood at 280,676 thousand yen, a decrease of 369,853 thousand yen from the previous fiscal year end, reflecting adecrease of account payables of 289,652 thousand yen mainly due to the purchase of TREAKISYM®.
Net assets stood at 5,364,648 thousand yen, a decrease of 1,240,915 thousand yen from the previous fiscal year end due toquarterly net loss of 1,259,647 thousand yen. This results in a increase of capital-to-asset ratio by 3.7 percentage points from theprevious fiscal year end to 94.7%.

(3) Forecast of financial results
The sales forecast for FY2012 is expected to be 1,966 million yen, 372 million yen lower than budget. For SyB D-0701, ourantiemetic patch, data analysis will not be completed until the first half of next year. due to the time required for completion ofpatient registration, Thus, there is no possibility of out-licensing product rights for SyB D-0701 this year, decreasing the sales
forecast with no upfront revenue on contracts for SyB D-0701 and fluctuation in the number of vials per delivery for
TREAKISYM® , our oncology product being marketed in Japan.
While the reduction in SG&A costs have exceeded expectations with the use of cost-saving measures, we expect to register
1,862 million yen as net loss due to lower sales.
*Any forward-looking statements in this material, including the forecast of financial results, are estimates based on information
available at the time and certain assumptions that the management believes to be reasonable. Actual results may differ
substantially from such forecasts due to various factors.

2. Other Summary Information (Explanatory Notes)(1) Additional information(Application of Accounting Standard for Accounting Changes and Error Corrections and its Implementation Guidance)“Accounting Standard for Accounting Changes and Error Correction” (ASBJ Statement No. 24, December 4, 2009) and“Implementation Guidance on Accounting Standard for Accounting Changes and Error Corrections” (ASBJ Guidance No. 24,
December 4, 2009) are applied to any accounting changes and error corrections for prior reporting periods that are made after
the beginning of the first quarter of Fiscal 2012.

－

2

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SymBio Pharmaceuticals Limited (4582) － Financial Results for the Third Quarter of Fiscal Year Ending December 31, 2012
[Japan GAAP] (Non-consolidated)

3. Quarterly Financial Statements(1) Quarterly balance sheet(Unit: Thousand yen)
Fiscal 2011

3rd Quarter Fiscal 2012

(December 31, 2011)(September 30, 2012)

AssetsCurrent assets
Cash and deposits
Accounts receivable

4,558,714
162,4092,869,020
156,881Marketable securities
Merchandise and finished goods

1,952,533
207,467

2,253,200―

79,038
124,589

121,417
131,921

Prepaid expenses
Advances
Other
Total current assets

93,63837,425

7,178,392

5,569,867

2,468

2,684

Fixed assets
Tangible fixed assets
Building (net)Fixtures and equipment (net)

14,93812,459Total tangible fixed assets

17,407

15,144

SoftwareLease assets

9,541
3,189

8,930
2,702

Total intangible fixed assets

12,730

11,633

Investments and other assets
Long-term prepaid expenses

24,30018,979Intangible fixed assets

Fixed leasehold deposits and security deposits

23,26429,700Total investments and other assets

47,564

48,680Total fixed assets

77,70275,457

7,256,094

5,645,325

Trade accounts payable
Other accounts payable

308,953
277,898

19,300176,512

Income taxes payable
Other

19,07339,821

8,943
71,889Total current liabilities

645,746

276,646

2,092

1,844

Total assets
Liabilities
Current liabilities

Long-term liabilities
Allowance for retirement benefits
Other

2,691

2,186

Total long-term liabilities

4,783

4,030

650,529

280,676

Total liabilities

－

3

－

SymBio Pharmaceuticals Limited (4582) － Financial Results for the Third Quarter of Fiscal Year Ending December 31, 2012
[Japan GAAP] (Non-consolidated)(Unit: Thousand yen)
Fiscal 2011

3rd Quarter Fiscal 2012

(December 31, 2011)(September 30, 2012)

Net assets
Shareholders’ equity
Capital stock
Capital surplus

6,024,610
5,994,610

6,024,610
5,994,610

Earned surplus
Treasury shares(5,413,091)(17)(6,638,323)(17)

Total shareholders’ equity

6,606,110

5,346,463

Appraisal and conversion variance, etc.
Other marketable securities appraisal variance

(546)

12

Total appraisal and conversion variance, etc.

(546)

12

－

18,172

6,605,564

5,364,648

7,256,094

5,645,325

Stock acquisition rights
Total net assets
Total liabilities and net assets

－

4

－

SymBio Pharmaceuticals Limited (4582) － Financial Results for the Third Quarter of Fiscal Year Ending December 31, 2012
[Japan GAAP] (Non-consolidated)(2) Quarterly income statement(Nine months ended September 30)(Unit: Thousand yen)First nine months of Fiscal 2011 First nine months of Fiscal 2012
(From January 1, 2011
to September 30, 2011)
Net sales
Cost of sales
Gross profit(From January 1, 2012
to September 30, 2012)

1,306,894

1,518,446

891,549

1,033,570

415,345484,875

Selling, general and administrative expenses

2,173,104

1,723,584

Operating (loss)(1,757,759)(1,238,704)

Non-operating income
Interest income

693

1,275

Interest on securities
Refunded consumption tax

1,864
－

2,347
654

Dividends income of insurance
Income from subvention

1,044
51,891

1,122
－

Other

21

147

55,514

5,547

664

128

Fees
New share issuance expense

16,828
7,000

8,107
－

Foreign exchange loss
IPO preparation costs

18,15522,074

15,045－－320

Total non-operating income
Non-operating expenses
Interest expense

Other
Total non-operating expenses
Ordinary (loss)
Extraordinary loss
Loss on disposal of fixed assets

64,72323,600(1,766,967)(1,256,757)－

39

Impact of application of accounting standard for asset
retirement obligations

5,331

－

Total extraordinary loss

5,331

39

Quarterly (loss) before tax(1,772,298)(1,256,797)

2,850

2,850

2,850

2,850

(1,775,148)(1,259,647)

Corporate tax, local inhabitant tax, and local enterprisetax
Total income tax
Quarterly net (loss)

－

5

－

SymBio Pharmaceuticals Limited (4582) － Financial Results for the Third Quarter of Fiscal Year Ending December 31, 2012
[Japan GAAP] (Non-consolidated)(3) Explanatory note regarding the assumption of the Company as going concern
None to be reported.

(4) Explanatory note regarding significant fluctuation in the shareholders’ equity
None to be reported.

(5) Important subsequent events
None to be reported.

－6－