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

Financial Results for the Second Quarter of Fiscal Year Ending December 31, 2012
[Japan GAAP] (Non-consolidated)
August 8, 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:

August 10, 2012

Scheduled date ofdividend payment:―

Supplementary materials for the financial statements:

No

Presentation to explain for the financial statements:

Yes (for securities analysts and institutional investors)(Million yen – rounded down, unless otherwise stated)

1. Business Results for the Second Quarter of Fiscal 2012 (January 1, 2012 to June 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

%

1,054
982

7.3

-874
-701

－

-895
-700

－

-897
-707

－

2nd Quarter Fiscal 2012
2nd Quarter Fiscal 2011－－

Quarterly net profit per
share

Diluted quarterly net
profit per share

Yen-46.92Yen

2nd Quarter Fiscal 2012
2nd Quarter Fiscal 2011-53.56－－－－(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
2nd Quarter Fiscal 2012
Fiscal 2011
(Reference) Shareholders’ equity

Net assets

Equity ratio

Million yen
6,352

Million yen
5,715

%
89.9

7,256

6,605

91.0

2nd Quarter Fiscal 2012

5,708 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

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

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
2,338

Operating profit% Million yen
24.2-1,625

Ordinary profit% Million yen－-1,652

Net profit% Million yen－-1,656

Net profit per share%－

Yen-86.56(Note) Revision of forecast of financial results during this quarter: No* 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

2nd Quarter(including treasury shares)

Fiscal 2012

Number of treasury shares at the end of

2nd Quarter

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

2nd Quarter
Fiscal 2012

19,130,900sharesFiscal 2011

19,130,900shares

75sharesFiscal 2011

75shares19,130,825shares

2nd Quarter
Fiscal 2011

13,205,700shares* 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.

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

4. Quarterly Financial Statements ...............................................................................................................................................

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

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

5(Six months ended June 30) ........................................................................................................................................

5(3) Quarterly cash flow statement ...........................................................................................................................................

6(4) Explanatory note regarding the assumption of the Company as going concern ................................................................

8(5) Explanatory note regarding significant fluctuation in shareholders’ equity ......................................................................

8(6) Important subsequent events .............................................................................................................................................

8

SymBio Pharmaceuticals Limited (4582) － Financial Results for the Second 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 evaluationsof data from clinical trials and consulted with the Pharmaceuticals and Medical Devices Agency (hereinafter “the Agency”)
prior to the application for approval in the first six months of the current fiscal year.
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 andsafety of SyB L-0501 in combination with rituximab. 63 cases were registered in these trials, of which 59 cases wereanalyzed. 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 patients with relapsed/refractory non-Hodgkin’s lymphoma. Side-effects were clinically controllable andthe therapy was applicable to 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.
We will decide on the future development plan discussing with the business partner Eisai.
We also continued the patient enrollment for Phase II clinical trials for untreated indolent non-Hodgkin’s lymphoma andmantle cell lymphoma as well as Phase II clinical trials for relapsed/refractory multiple myeloma.
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 completed in June 2012 and we initiateddomestic Phase I clinical trials.
We continued the patient enrollment for Phase II clinical trials of SyB D-0701, a transdermal antiemetic patch, for theindication of radiotherapy-induced nausea and vomiting.
2. Overseas
The business partner InnoPharmax Inc. (Taiwan) started to sell SyB L-0501 in Taiwan in February 2012. The sales weresteady in Singapore and South Korea, where we sell the product through Eisai as in Japan.
3. Business results
As a result of aforementioned developments, net sales totaled 1,054,302 thousand yen (an increase by 7.3% from the same
period of the previous fiscal year) in the first six 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 1,139,819 thousand yen (an increase by 9.9% from the same periodof the previous fiscal year), which comprised research and development cost of 698,546 thousand yen (an increase by 5.8%
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 of441,272 thousand yen (an increase by 17.1% from the same period of the previous fiscal year).
As a result, we posed operating loss of 874,322 thousand yen in the first six months of the current fiscal year (comparedto operating loss of 701,333 thousand yen in the same period of the previous fiscal year). Non-operating expenses of 24,334－

1－

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

thousand yen were recorded mainly due to foreign exchange loss, resulting in ordinary loss of 895,748 thousand yen and net
quarterly loss of 897,688 thousand yen (compared to losses of 700,109 and 707,340 thousand yen in the same period of theprevious 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 6,352,541 thousand yen at the end of the second quarter of the current fiscal year, a decrease of 903,553
thousand yen from the previous fiscal year end. Current assets stood at 6,259,328 thousand yen, a decrease of 919,063
thousand yen from the previous fiscal year end, reflecting a decrease of cash and deposits by 1,256,948 thousand yen due
mainly to expenditures for research and development costs and selling, general and administrative expenses, while accounts
receivable increased by 144,880 thousand yen due to sales of TREAKISYM® and marketable securities increased by 300,499
thousand yen. Fixed assets increased to 93,212 thousand yen by 15,510 thousand yen from the previous fiscal year end
primarily because a portion of development costs was capitalized as long-term prepaid expense.
Liabilities remained almost unchanged from the previous fiscal year end at 636,814 thousand yen (compared to 650,529
thousand yen at the previous fiscal year end).
Net assets stood at 5,715,726 thousand yen, a decrease of 889,838 thousand yen from the previous fiscal year end due toquarterly net loss of 897,688 thousand yen. This results in a decrease of capital-to-asset ratio by 1.1 percentage points from theprevious fiscal year end to 89.9%.

(3) Forecast of financial results
There has been no change to forecast of financial results for the fiscal year ending December 31, 2012 at this point in time.

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

－

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

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

2nd Quarter Fiscal 2012

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

AssetsCurrent assets
Cash and deposit
Accounts receivable

4,558,714
162,4093,301,766
307,290

Marketable securities
Merchandise and finished goods

1,952,533
207,467

2,253,033
111,206

79,038
124,589

118,235
148,824

Prepaid expenses
AdvancesOther

93,63818,972

7,178,392

6,259,328

2,468

2,731

Fixtures and equipment (net)

14,93812,323

Total tangible fixed assets

17,407

15,055

SoftwareLease assets

9,541
3,189

8,977
2,864

Total intangible fixed assets

12,73011,841

Investments and other assets
Long-term prepaid expenses

24,30035,681

Fixed leasehold deposit and security deposit

23,26430,633

Total investments and other assets

47,564

66,314

Total current assets
Fixed assets
Tangible fixed assets
Building (net)

Intangible fixed assets

Total fixed assets

77,702

93,212

7,256,094

6,352,541

Trade accounts payable
Other accounts payable

308,953
277,898

325,352
220,010

Income taxes payable
Other

19,07339,821

15,36271,808

Total current liabilities

645,746

632,534

2,092

1,925

Other

2,691

2,355

Total long-term liabilities

4,783

4,280

650,529

636,814

Total assets
Liabilities
Current liabilities

Long-term liabilities
Allowance for retirement benefits

Total liabilities

－

3

－

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

2nd Quarter Fiscal 2012

(December 31, 2011)(June 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)(6,310,779)(17)

Total shareholders’ equity

6,606,110

5,708,422

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

(546)

(23)

Total appraisal and conversion variance, etc.

(546)

(23)

－

7,327

6,605,564

5,715,726

7,256,094

6,352,541

Stock acquisition rights
Total net assets
Total liabilities and net assets

－

4

－

SymBio Pharmaceuticals Limited (4582) － Financial Results for the Second Quarter of Fiscal Year Ending December 31, 2012
[Japan GAAP] (Non-consolidated)(2) Quarterly income statement(Six months ended June 30)(Unit: Thousand yen)First six months of Fiscal 2011

First six months of Fiscal 2012

(From January 1, 2011
to June 30, 2011)(From January 1, 2012
to June 30, 2012)

Net sales

982,651

1,054,302

Cost of sales

646,800

788,804

Gross profit

335,850

265,497

Selling, general and administrative expenses

1,037,184

1,139,819

Operating (loss)(701,333)(874,322)

Non-operating income
Interest income

387

778

Interest on securities
Refunded consumption tax

1,253
－

1,475
654

Income from subvention
Other

51,89121－－

Total non-operating income

53,553

2,908

Non-operating expenses
Interest expense

586

118

Fees
New share issuing expense

11,157
7,000

5,385
－

Foreign exchange loss
IPO preparation costs

28,591
4,993

18,510－

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

320

52,32924,334(700,109)(895,748)－

39

Impact of application of accounting standard for
assets retirement obligations

5,331

－

Total extraordinary loss

5,331

39

Quarterly (loss) before tax(705,440)(895,788)

Corporate tax, local inhabitant tax, and local enterprise
tax

1,900

1,900

Total income tax

1,900

1,900

(707,340)(897,688)

Quarterly net (loss)

－

5

－

SymBio Pharmaceuticals Limited (4582) － Financial Results for the Second Quarter of Fiscal Year Ending December 31, 2012
[Japan GAAP] (Non-consolidated)(3) Quarterly cash flow statement(Unit: Thousand yen)First six months of Fiscal 2011
(From January 1, 2011

First six months of Fiscal 2012
(From January 1, 2012

to June 30, 2011)

to June 30, 2012)

Cash flow from operating activities
Quarterly (loss) before tax(705,440)(895,788)

Depreciation
Amortization of security deposit

3,941
1,194

4,178
626

－

39

5,331

－

200

(167)

Loss on disposal of fixed assets
Impact of application of accounting standard for asset
retirement obligations
Increase (decrease) in allowance for retirement
benefits
Share-based compensation expense

－

7,327

Interest income
Interest expense(1,641)586(2,253)118

Foreign exchange loss (gain)
New share issuing expense

3,374
7,000

2,280
－

Commission paid
Decrease (increase) in accounts receivable

11,157(174,481)

5,385(144,880)

Decrease (increase) in inventories
Decrease (increase) in prepaid expenses(236,176)(11,502)

96,261(44,581)

Decrease (increase) in advances
Decrease (increase) in other current assets

4,676(31,437)(24,235)
74,666

Decrease (increase) in long-term prepaid expenses
Increase (decrease) in trade accounts payable－
245,165(11,381)
16,398

Increase (decrease) in other accounts payable
Increase (decrease) in other current liabilities

64,196(9,824)(58,256)
28,276

－
226

(335)
147

(823,454)(946,173)

1,585
(586)

2,196
(96)

Increase (decrease) in other long-term liabilities
Other
SubtotalInterest and dividends received
Interest paid
Income taxes paid

(1,900)(1,900)(824,355)(945,974)

Payment for purchase of marketable securities
Proceeds from redemption of marketable securities(100,610)
100,000(300,000)
100,000

Expenditures for purchase of tangible fixed assets
Expenditures for purchase of intangible fixed assets(1,167)(10,940)－(630)

Payment for fixed leasehold deposit and security
deposit(432)(7,995)50－

Cash flow from operating activities
Cash flow from investing activities

Proceeds from redemption of fixed leasehold deposit
and security deposit(13,099)(208,625)

Cash flow from financing activities
Increase (decrease) in short-term borrowing

Cash flow from investing activities

250,000－

Proceeds from issuance of new stock
Payment for issuance of new stock

2,000,040(7,000)－－Cash flow from financing a tivities

2,243,039

－

－

6

－

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

First six months of Fiscal 2012

(From January 1, 2011
to June 30, 2011)(From January 1, 2012
to June 30, 2012)

Effect of foreign exchange rate changes on cash and cash

(3,458)(1,758)

Increase (decrease) in cash and cash equivalents

1,402,126(1,156,358)

Cash and cash equivalents at the beginning of the period

3,915,765

6,310,978Cash and cash equivalents at the end of the period

5,317,891

5,154,619

equi alents

－

7

－

SymBio Pharmaceuticals Limited (4582) － Financial Results for the Second Quarter of Fiscal Year Ending December 31, 2012
[Japan GAAP] (Non-consolidated)(4) Explanatory note regarding the assumption of the Company as going concern
None to be reported.

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

(6) Important subsequent events
None to be reported.

－8－