English translation

Summary of Financial Results
for the Second Quarter of Fiscal Year Ending December 31, 2016
[Japanese GAAP] (Non-consolidated)
August 4, 2016
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

Director, Finance & Accounting

Contact Person
Scheduled Date to File
Quarterly Report

Tetsuya Maruyama
Date of Dividend
Payment (plan)

August 5, 2016

TEL +81-3-5472-1125－

Supplementary materials for 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 2016 (January 1, 2016 to June 30, 2016)(1) Operating Results (cumulative)(Percentages indicate year-on-year changes)

Operating Income(loss)Net Sales

Quarterly Net Income(loss)

millions of yen%

millions of yen%

millions of yen%

millions of yen

%

1,210
976

24.0
0.1

(819)
(647)

－
－

(1,177)(673)－－(1,175)(676)－－

2Q FY 2016
2Q FY 2015

Quarterly Net Income(loss) per share

Diluted Quarterly Net
Income per share

Yen(33.93)(20.88)Yen－－

2Q FY 2016
2Q FY 2015
(2) Financial Position

Total Assets
2Q FY 2016 (as of June 30, 2016)
FY 2015 (as of December 31, 2015)(Reference) Equity:

Ordinary Income(loss)

millions of yen
7,477
4,984

2Q FY 2016 (as of June 30, 2016)
FY 2015 (as of December 31, 2015)

Net Assets

Equity Ratio

millions of yen
5,429
4,431

%
67.8
82.9

5,066 million yen
4,131 million yen

2. Dividends

FY 2015
FY 2016
FY 2016 (Forecast)

1st Quarter
Yen－－

Annual Dividend per Share
2nd Quarter
3rd Quarter
Fiscal Year End
Yen
Yen
Yen
0.00
－
0.00
0.00
－
0.00

(Note) Revision of dividend forecasts recently announced:

Yes ・ No

Full Year
Yen
0.00
0.00

3. Earnings Forecasts for FY 2016 (January 1, 2016 to December 31, 2016)(Percentages indicate year-on-year changes)

Operating
Income (loss)

Net Sales
millions of yen

Full Year

2,339% millions of yen

21.0(2,778)

Ordinary
Income (loss)

Net Income (loss)
per share% millions of yen%

millions of yen%

Yen(2,811)－(2,815)－(68.33)－

Yes ・ No

(Note) Revision of earnings forecasts recently announced:

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

Net Income (loss)

Yes ・ No

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

Yes ・ No(b) Changes in accounting policies due to otherreasons:

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

2Q FY 2016

41,199,074 shares

FY 2015

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

2Q FY 201675 shares

FY 201575 shares(iii) Average number of shares during the period(cumulative)

2Q FY 2016

34,643,145 sharesthe period (including treasury stock)

2Q FY 2015

32,390,848 shares* Status of quarterly review
The review of quarterly financial statements as required by the Financial Instruments and Exchange Act was underway 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 assumptions judged to be reasonable. Actual results may differ substantially from these forecasts due to various
factors. Regarding the 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 second quarter of fiscal year ending December 31, 2016

Index of the 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) Statements of operations (cumulative)…………………………………………………………………………………..

5(3) Quarterly cash flow statements …………………………………………………………………………………………

6(4) Notes on quarterly financial statements …………………………………………………………………………………

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

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

8(Significant subsequent events) …………………………………………………………..……………….………………

8

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the second quarter of fiscal year ending December 31, 2016

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 2016 is as follows:(i) Domestic[Anticancer agent: SyB L-0501 (generic name: bendamustine hydrochloride, trade name: TREAKISYM®)]
The Company markets TREAKISYM® in Japan through its business partner, Eisai Co., Ltd. (“Eisai”), for the indicationsof refractory/relapsed low-grade non-Hodgkin’s lymphoma and mantle cell lymphoma. Net sales through Eisai increased as
expected.
For patients who need new therapies and to maximize the product value of TREAKISYM®, the Company continues topursue three additional indications:Regarding the indications of first-line low-grade non-Hodgkin’s lymphoma and mantle cell lymphoma, the Company
filed a supplemental New Drug Application (sNDA) in Japan to the Pharmaceuticals and Medical Devices Agency(“PMDA”) in December 2015. In the EU, the Company received a notice from Astellas Pharma GmbH (Head office:Germany) that they withdrew their application in January 2016. However, the Company has continued with procedures forapproval in Japan in consultation with the PMDA.
Regarding the indication of chronic lymphocytic leukemia, the Company filed a sNDA in Japan in December 2015; thiswas followed by a specialist consultation by the PMDA in June 2016. Approval processes are underway towards early
approval. TREAKISYM® was designated as an orphan drug (pharmaceutical for the treatment of rare diseases) for theindication of chronic lymphocytic leukemia in June 2012. In addition, the “Evaluation Committee on Unapproved or OffLabeled Drugs with High Medical Needs,” a committee established by the Ministry of Health, Labour and Welfare in Japan,
requested the Company to further develop TREAKISYM®.
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.
[Anticancer agents: SyB L-1101 (intravenous formulation) and SyB C-1101 (oral formulation), generic name: rigosertib]
For the global Phase III trial of the intravenous formulation of rigosertib conducted by Onconova Therapeutics, Inc.
(Head office: Pennsylvania, U.S.; “Onconova”), the U.S. Licensor of the agent, the Company is in charge of the clinicaldevelopment in Japan and has started the domestic trial in December 2015. The global Phase III trial is conducted withclinical trial sites in more than ten countries worldwide, for higher-risk myelodysplastic syndrome (HR-MDS) patients who
do not respond to the current standard treatment with hypomethylating agents (HMAs) or who relapse after treatment under
the current standard of care (“primary HMA failure”). The Company worked on procedures to enroll patients with thedisease and accordingly completed the first patient enrollment in July 2016, after the end of the second quarter of fiscal year
ending December 31, 2016.
Regarding the oral formulation of rigosertib, the Company started its domestic Phase I clinical trial of the oral
formulation of rigosertib in combination with azacitidine (Note) for the target indication of HR-MDS in December 2015,
but the provision of the investigational drug of this clinical trial has been delayed, and at present, patient enrollment has not
yet been started. As soon as this issue is resolved, the Company will commence patient enrollment, complete this clinical
trial as planned, and consider its participation in the global Phase III clinical trial to be conducted by Onconova.
(Note)

About azacitidine (Vidaza®: currently marketed by Nippon Shinyaku Co., Ltd.): This drug was confirmed toextend overall survival for the first time in the Phase III clinical trial for the indication of HR-MDS, and wasapproved in Japan in 2011. It is currently used as a first-line drug for MDS patients who have difficulties inhematopoietic stem cell transplantation.

[Patient-controlled iontophoretic transdermal system for the short-term management of acute postoperative pain: SyB P1501]
In October 2015, the Company entered into an agreement with Incline Therapeutics, Inc., a wholly-owned subsidiary of
U.S.-based The Medicines Company (Head office: New Jersey, U.S.), for an exclusive license to develop andcommercialize in Japan SyB P-1501. The Company commenced a domestic Phase III clinical trial for SyB P-1501 in June,
examining the applicability of the drug for inpatients to control short-term acute postoperative pain. The Company intends
to complete the Phase III clinical trial at the earliest possible time, with the aim of obtaining approval by the end of 2019.

-1-

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the second quarter of fiscal year ending December 31, 2016

[New drug candidates]
The Company continued with search and evaluation activities to acquire license rights of new drug candidates in global
terms, aiming to grow into a bio-pharmaceutical company with both profitability and growth potential, always from a
medium-to-long-term perspective.
Meanwhile, in May 2016, the Company established a wholly-owned subsidiary, SymBio Pharma USA, Inc. (Head office:Menlo Park, California, U.S., “SymBio Pharma USA”), as the Company’s strategic base for its overseas businessdevelopment. The Company will accelerate its transformation into a global specialty bio-pharmaceutical company byactively acquiring the worldwide rights concerning new drug candidates, developing and commercializing new drugs in the
U.S., Japan, Europe and other global major markets.
(ii) Overseas
SyB L-0501 is also marketed in South Korea, Taiwan and Singapore, and product sales of SyB L-0501 in these countries
grew steadily as planned.
(iii) Business results
As a result of the above, net sales totaled 1,210,725 thousand yen for the second quarter of fiscal year ending December
31, 2016, primarily reflecting product sales of TREAKISYM® in Japan. Product sales showed a year-on-year increase of
20.9%, and the Company recorded non-recurring revenue resulting from achieving the sales milestone of SyB L-0501 in
Taiwan. Accordingly, overall net sales rose 24.0% year-on-year.
Selling, general and administrative expenses totaled 1,224,729 thousand yen (a year-on-year increase of 31.6%),
including research and development (“R&D”) expenses of 518,349 thousand yen (a year-on-year increase of 28.4%)
primarily due to expenses associated with the clinical trial for the intravenous and oral formulations of rigosertib andpreparations for the clinical trial of SyB P-1501, and other selling, general and administrative expenses of 706,379 thousandyen (a year-on-year increase of 34.1%) primarily due to expenses associated with negotiating license agreements for new
drug candidates or takeovers of firms that are in possession of new drug candidates.
As a result, operating loss of 819,937 thousand yen was recognized for the second quarter of fiscal year ending
December 31, 2016 (operating loss of 647,968 thousand yen for the second quarter of the previous fiscal year). In addition,
mainly because the Company recorded non-operating expenses totaling 360,324 thousand yen primarily comprising foreignexchange loss, ordinary loss totaled 1,177,202 thousand yen (ordinary loss of 673,992 thousand yen for the second quarter ofthe previous fiscal year) and net loss totaled 1,175,338 thousand yen (net loss of 676,424 thousand yen for the second
quarter of the previous 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 June 30, 2016 stood at 7,477,080 thousand yen, an increase of 2,492,790 thousand yen from theprevious fiscal year end. This was primarily due to increases of 2,000,000 thousand yen in marketable securities, 570,483
thousand yen in cash and deposits, 43,601 thousand yen in accounts receivable-trade, 24,329 thousand yen in prepaid
expenses and 13,310 thousand yen in tools, furniture and fixtures, offsetting decreases of 133,029 thousand yen inmerchandise and finished goods and 25,569 thousand yen in advances paid.
Liabilities stood at 2,047,676 thousand yen, an increase of 1,495,199 thousand yen from the previous fiscal year end. Thiswas primarily due to a decrease of 110,837 thousand yen in accounts payable-trade which was offset by increases of
1,575,000 thousand yen in bonds payable and 12,315 thousand yen in income taxes payable.
Net assets increased by 997,591 thousand yen from the previous fiscal year end to 5,429,403 thousand yen, due to theissuance of new shares and stock acquisition rights, offsetting a decrease of 1,175,338 thousand yen in retained earnings
following the recognition of net loss.
As a result, the equity ratio decreased by 15.1 percentage points from the previous fiscal year end to 67.8%.
(3) Qualitative information concerning earnings forecasts
No revision was made to the earnings forecasts for FY 2016 as of the date of this document.

-2-

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the second quarter of fiscal year ending December 31, 2016

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

FY 2015(as of December 31, 2015)

2Q FY 2016(as of June 30, 2016)

AssetsCurrent assets
Cash and deposits
Accounts receivable-trade4,261,438
300,742

4,831,922
344,344

Marketable securities
Merchandise and finished goods－
133,0292,000,000

Prepaid expenses
Advances paid

38,591
79,639－62,92054,069Other

13,337

22,613

4,826,778

7,315,870

Buildings, net
Tools, furniture and fixtures, net

22,20830,747

21,49344,058

Total property, plant and equipment

52,95665,552

Total current assets
Non-current assets
Property, plant and equipment

Intangible assets
Software50,50642,084

Software in progress
Lease assets

900
594

1,250
270

Total intangible assets

52,001

43,604Long-term prepaid expenses
Lease and guarantee deposits－
1,227
51,326903
51,148

Total investments and other assets

52,55352,052

Investments and other assets
Shares of subsidiaries

Total non-current assets

0157,510161,209

4,984,289

7,477,080

Accounts payable-trade
Accounts payable-other319,866
183,690

209,029
192,623

Income taxes payable
Forward exchange contracts

14,183
14,99926,49824,559Total assets
Liabilities
Current liabilities

Other

18,20018,629Total current liabilities

550,940

471,338

Bonds payable
Provision for retirement benefits

－
1,537

1,575,000
1,338

Total non-current liabilities

1,537

1,576,338

552,477

2,047,676

Non-current liabilities

Total liabilities-3-

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the second quarter of fiscal year ending December 31, 2016

(Unit: thousands of yen)

FY 2015(as of December 31, 2015)

2Q FY 2016(as of June 30, 2016)

Net assets
Shareholders’ equity
Common stock

8,330,775

9,385,798

Capital surplus
Retained earnings

8,300,775(12,499,609)

9,355,798(13,674,948)

(17)

(17)

4,131,924

5,066,629

299,887362,773

4,431,811

5,429,403

4,984,289

7,477,080

Treasury stock
Total shareholders’ equity
Stock acquisition rights
Total net assets
Total liabilities and net assets-4-

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the second quarter of fiscal year ending December 31, 2016(2) Statements of operations (cumulative)(For the second quarter of the fiscal year ending December 31, 2016)(Unit: thousands of yen)

2Q FY 2015
(from January 1, 2015
to June 30, 2015)
976,194

2Q FY 2016
(from January 1, 2016
to June 30, 2016)
1,210,725

Cost of goods sold693,610805,933

Gross profit

282,584

404,792

Selling, general and administrative expenses

930,553

1,224,729

Operating loss

(647,968)(819,937)

6,919

2,973

Interest on securities
Other

1,700
24

81
4

Total non-operating income

8,645

3,058

Interest expenses
Commission fees

7
4,450

3
4,487

Stock issuance costs
Foreign exchange losses

160
29,3797,497
330,411Net sales

Non-operating income
Interest income

Non-operating expenses

Other
Total non-operating expenses
Ordinary loss
Extraordinary gain
Gain on reversal of stock acquisition rights
Total extraordinary gain
Extraordinary loss
Loss on retirement of non-current assets
Total extraordinary losses

671

17,92534,669360,324(673,992)(1,177,202)

689

4,903

689

4,903

1,221

1,139

1,221

1,139

(674,524)(1,173,438)

Income taxes-current

1,900

1,900

Total income taxes

1,900

1,900

(676,424)(1,175,338)

Loss before income taxes

Net loss-5-

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the second quarter of fiscal year ending December 31, 2016(3) Quarterly cash flow statements(Unit: thousands of yen)First six months of Fiscal 2015
(from January 1, 2015
to June 30, 2015)

First six months of Fiscal 2016
(from January 1, 2016
to June 30, 2016)

Net cash provided by (used in) operating activities
Quarterly (loss) before income taxes(674,524)(1,173,438)

Depreciation
Share-based compensation expenses

11,71549,076

12,70465,039

Increase (decrease) in provision for retirement benefits
Interest income(207)(8,620)(199)(3,054)

Interest expenses
Foreign exchange losses (gains)

7
4,190

3
359,903

Commission fees
Stock issuance cost

4,450
160

4,487
7,497

Gain on reversal of stock acquisition rights
Loss on retirement of non-current assets

(689)
1,221

(4,903)
1,139

Decrease (increase) in accounts receivable
Decrease (increase) in inventories

22,852(191,482)(43,601)
133,029

Decrease (increase) in prepaid expenses
Decrease (increase) in advances paid

9,711
12,513(28,817)
25,569Decrease (increase) in consumption taxes receivable
Decrease (increase) in current assets-other

3,655
20,540－469

Decrease (increase) in long-term prepaid expenses
Increase (decrease) in accounts payable-trade

1,151
268,298

323(110,837)

Increase (decrease) in accounts payable-other
Increase (decrease) in other current liabilities(34,930)
(522)

9,193
13,535

Other(1,488)17,925

Subtotal(502,918)(714,030)

8,434
(7)

2,868
(3)

Interest and dividends income received
Interest expenses paid
Income taxes paid
Net cash provided by (used in) operating activities(1,900)(1,900)(496,391)(713,064)

400,000－(0)

Net cash provided by (used in) investing activities
Proceeds from redemption of securities
Purchase of shares of subsidiaries
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-6-－(11,974)(900)(18,939)(1,250)

(432)

(218)

16,420－403,113(20,407)

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the second quarter of fiscal year ending December 31, 2016
(Unit: thousands of yen)First six months of Fiscal 2015
(from January 1, 2015
to June 30, 2015)

First six months of Fiscal 2016
(from January 1, 2016
to June 30, 2016)－

678,018－

3,000,000－(1,850)(344)(5,659)(349)

Net cash provided by (used in) financing activities
Proceeds from issuance of shares resulting fromexercise of stock acquisition rights
Proceeds from issuance of bonds with stockacquisition rights
Proceeds from issuance of stock acquisition rights
Payments for issuance of common stock
Repayments for lease obligations
Other payments

9,776

(90)

(17,925)(2,284)

3,663,859(4,190)(359,903)(99,753)

2,570,483

5,092,075

4,261,438

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
Cash and cash equivalents at the beginning of the period
Cash and cash equivalents at the end of the period

4,992,321

6,831,922-7-

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the second quarter of fiscal year ending December 31, 2016(4) Notes on quarterly financial statements(Notes regarding going concern assumption)
None to be reported.
(Notes regarding significant changes in shareholders’ equity)
During the second quarter of fiscal year ending December 31, 2016, common stock and legal capital surplus increased by
712,500 thousand yen and 712,500 thousand yen respectively. This was due to the conversion into new shares in response to
the exercise of part of stock acquisition rights granted to the 3rd unsecured convertible bonds. In addition, following theissuance of new shares upon the exercise of part of the 34th stock acquisition rights, common stock and legal capital surplus
increased by 342,522 thousand yen and 342,522 thousand yen respectively.
As a result, common stock and legal capital surplus increased by 1,055,022 thousand yen and 1,055,022 thousand yen
respectively, amounting to 9,385,798 thousand yen and 9,355,798 thousand yen respectively as of June 30, 2016.
(Significant subsequent events)
Issuance of new shares on the exercise of stock acquisition rights for bonds with stock acquisition rights
During the period from July 1, 2016 to August 4, 2016, a portion of the 3rd unsecured convertible bonds with stockacquisition rights was converted into new shares based on the exercise of rights. The summary of such exercise of the stockacquisition rights is as follows.
Number and type of shares issued:

710,900 shares of common stock

Total amount issued:
Decrease in convertible bonds with stock acquisition rights

150,000 thousand yen
150,000 thousand yen

Amount transferred to capital from the total amount issued:

75,000 thousand yen-8-