English translation

Summary of Financial Results
for the Third Quarter of Fiscal Year Ending December 31, 2016
[Japanese GAAP] (Non-consolidated)
Company Name

SymBio Pharmaceuticals Limited

November 11, 2016
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

Makio Yamaguchi
Date of Dividend
Payment (plan)

November 14, 2016

Supplementary materials for quarterly financial results:

Yes

No

Holding of quarterly earnings performance review:

Yes

No

TEL +81-3-5472-1125－(millions of yen – rounded down, unless otherwise stated)

1. Business Results for the Third Quarter of FY 2016 (January 1, 2016 to September 30, 2016)(1) Operating Results (cumulative)(Percentages indicate year-on-year changes)
Operating Income
Ordinary Income
Quarterly Net Income
Net Sales(loss)(loss)(loss)
millions of yen%

millions of yen%

millions of yen%

millions of yen

%

1,407
1,332

5.6
(1.2)

(1,532)(987)－－(1,916)(1,056)－－(1,915)(1,059)－－3Q FY 2016
3Q FY 2015

Quarterly Net Income(loss) per share

Diluted Quarterly Net
Income per share

Yen(51.61)(32.71)Yen－－

3Q FY 2016
3Q FY 2015
(2) Financial Position

3Q FY 2016 (as of September 30, 2016)
FY 2015 (as of December 31, 2015)(Reference) Equity:

Total Assets

Net Assets

millions of yen
6,987
4,984

millions of yen
5,629
4,431

3Q FY 2016 (as of September 30, 2016)

5,226 million yen

FY 2015 (as of December 31, 2015)

4,131 million yen

Equity Ratio
%
74.8
82.9

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

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

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

－

－

(2,815)－(71.77)(2,811)
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
the period (including treasury stock)

3Q FY 2016

45,464,474 shares

FY 2015

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

3Q FY 201675 shares

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

3Q FY 201637,123,292 shares

3Q 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 summary of financial results.
* 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 third 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) Notes on quarterly financial statements …………………………………………………………………………………

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

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

6(Significant subsequent events) …………………………………………………………..……………….………………

6

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the third 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 third 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.
By pursuing four indications, the Company has already obtained approvals for two indications, and continues to pursue
approval for the remaining two additional indications, for patients who need new therapies and for maximizing the businessvalue of TREAKISYM®.
The Company filed a supplemental New Drug Application (sNDA) in Japan in December 2015 for the indication ofchronic lymphocytic leukemia, and obtained approval for the additional indication in August 2016. The Company has
developed and applied for this indication upon request of the Ministry of Health, Labour and Welfare in Japan as one of the“Unapproved or Off-Labeled Drugs with High Medical Needs.” This is the second approval after the approval of an sNDA
for the indication of refractory/relapsed low-grade non-Hodgkin’s lymphoma and mantle cell lymphoma which theCompany has already received in October 2010.
Regarding the indications of first-line low-grade non-Hodgkin’s lymphoma and mantle cell lymphoma, the Company
filed an sNDA in Japan to the Pharmaceuticals and Medical Devices Agency (“PMDA”) in December 2015. In the EU, theCompany 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 for obtaining approval in Japan in consultation with
the PMDA.
Lastly, 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
Sodium]Regarding these agents, for which a license agreement was entered into in July 2011, the Company has changed theirgeneric name from “Rigosertib” to “Rigosertib Sodium” in accordance with the notice of decision on its Japanese Accepted
Names for Pharmaceuticals (JAN) received in October 2016. For the global Phase III trial of the intravenous formulation of
Rigosertib Sodium 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 clinical development in Japan and started the domestic trial in
December 2015. The global Phase III trial is conducted with clinical trial sites in more than ten countries worldwide, forhigher-risk myelodysplastic syndrome (HR-MDS) patients who do not respond to the current standard treatment withhypomethylating 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 the disease and accordingly completed the first patient
enrollment in Japan in July 2016. Enrollments are currently accumulating.
Regarding the oral formulation of Rigosertib Sodium, the Company started its domestic Phase I clinical trial of the oral
formulation of Rigosertib Sodium in combination with azacitidine (Note) for the target indication of HR-MDS in December
2015. However, the provision of the investigational drug of this clinical trial by Onconova has been delayed. At present,
patient enrollment has not yet been started. As soon as this issue on the provision of the investigational drug is resolved, theCompany will resume 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

-1-

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

2016, 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.
[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. Negotiations for multiple licensing agreements are currently underway.
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. By actively acquiring the worldwide rights concerning new drug candidates with SymBio Pharma USA as thebase of global business, the Company will accelerate its transformation into a global specialty bio-pharmaceutical company
with the aim of developing and commercializing new drugs in the U.S., Japan, Europe and other major global 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 1,407,613 thousand yen for the third 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 3.3%,
and the Company recorded non-recurring revenue resulting from achieving the sales milestone of SyB L-0501 in Taiwan.
Accordingly, overall net sales rose 5.6% year-on-year.
Selling, general and administrative expenses totaled 2,010,728 thousand yen (a year-on-year increase of 45.4%),
including research and development (“R&D”) expenses of 981,168 thousand yen (a year-on-year increase of 64.1%)
primarily due to expenses associated with obtaining the approval for the additional indications of TREAKISYM®, theclinical trial for the intravenous and oral formulations of Rigosertib Sodium and preparations for the clinical trial of SyB P1501, and other selling, general and administrative expenses of 1,029,560 thousand yen (a year-on-year increase of 31.2%)
primarily due to expenses associated with negotiating license agreements for new drug candidates or takeovers of companies
that are in possession of new drug candidates.
As a result, operating loss of 1,532,310 thousand yen was recognized for the third quarter of fiscal year ending
December 31, 2016 (operating loss of 987,692 thousand yen for the third quarter of the previous fiscal year). In addition,
mainly because the Company recorded non-operating expenses totaling 390,891 thousand yen primarily comprising foreignexchange loss, ordinary loss totaled 1,916,710 thousand yen (ordinary loss of 1,056,043 thousand yen for the third quarter ofthe previous fiscal year) and net loss totaled 1,915,796 thousand yen (net loss of 1,059,425 thousand yen for the third quarterof 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 September 30, 2016 stood at 6,987,250 thousand yen, an increase of 2,002,961 thousand yen from theprevious fiscal year end. This was primarily due to increases of 1,816,629 thousand yen in cash and deposits, 193,352
thousand yen in merchandise and finished goods, 23,807 thousand yen in prepaid expenses, 15,330 thousand yen in leaseand guarantee deposits and 14,023 thousand yen in tools, furniture and fixtures, offsetting decreases of 88,102 thousand yen
in accounts receivable-trade and 11,685 thousand yen in software.
Liabilities stood at 1,358,083 thousand yen, an increase of 805,606 thousand yen from the previous fiscal year end. Thiswas primarily due to increases of 675,000 thousand yen in bonds payable and 129,307 thousand yen in accounts payableother, which were offset by a decrease of 4,581 thousand yen in accounts payable-trade.
Net assets increased by 1,197,354 thousand yen from the previous fiscal year end to 5,629,166 thousand yen, due to theissuance of new shares and stock acquisition rights, offsetting a decrease of 1,915,796 thousand yen in retained earnings
following the recognition of net loss.
As a result, the equity ratio decreased by 8.1 percentage points from the previous fiscal year end to 74.8%.
(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 third 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)
AssetsCurrent assets
Cash and deposits
Accounts receivable-trade
Merchandise and finished goods
Prepaid expenses
Advances paid
Other

3Q FY 2016(as of September 30, 2016)

4,261,438
300,742
133,029
38,591
79,63913,337

6,078,068
212,639
326,381
62,39872,333
59,107

4,826,778

6,810,929

22,20830,747

20,971
44,771

52,95665,743

Intangible assets
Software
Software in progress
Lease assets

50,506900
594

38,821
4,250
108

Total intangible assets

52,001

43,179Investments and other assets
Shares of subsidiaries
Long-term prepaid expenses
Lease and guarantee deposits－
1,227
51,3260741
66,65652,55367,398

Total current assets
Non-current assets
Property, plant and equipment
Buildings, net
Tools, furniture and fixtures, net
Total property, plant and equipment

Total investments and other assets
Total non-current assets

157,510

176,321

4,984,289

6,987,250

319,866
183,690
14,183315,285
312,998
22,156

Forward exchange contracts
Other

14,99918,20015,921
15,263

Total current liabilities

550,940

681,624－
1,537－

675,000
1,342
117

Total assets
Liabilities
Current liabilities
Accounts payable-trade
Accounts payable-other
Income taxes payableNon-current liabilities
Bonds payable
Provision for retirement benefits
Other
Total non-current liabilities
Total liabilities

-3-

1,537

676,459

552,477

1,358,083

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

FY 2015(as of December 31, 2015)
Net assets
Shareholders’ equity
Common stock
Capital surplus
Retained earnings
Treasury stock
Total shareholders’ equity
Stock acquisition rights
Total net assets
Total liabilities and net assets-4-

3Q FY 2016(as of September 30, 2016)

8,330,775
8,300,775(12,499,609)(17)

9,835,798
9,805,798(14,415,406)(17)

4,131,924

5,226,171

299,887

402,994

4,431,811

5,629,166

4,984,289

6,987,250

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

Net sales
Cost of goods sold

3Q FY 2015
(from January 1, 2015
to September 30, 2015)
1,332,388
937,300

3Q FY 2016
(from January 1, 2016
to September 30, 2016)
1,407,613
929,195

395,087

478,418

Gross profit
Selling, general and administrative expenses

1,382,780

2,010,728

Operating loss

(987,692)(1,532,310)

9,730
2,519
1,072
24

5,017
249
1,221
4

13,347

6,491

11
6,713
160
74,142671

4
6,756
10,759356,057
17,315Non-operating income
Interest income
Interest on securities
Dividend income
Other
Total non-operating income
Non-operating expenses
Interest expenses
Commission fees
Stock issuance costs
Foreign exchange losses
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

81,697

390,891(1,056,043)(1,916,710)

689

4,903

689

4,903

1,221

1,139

1,221

1,139

(1,056,575)(1,912,946)

Income taxes-current

2,850

2,850

Total income taxes

2,850

2,850

(1,059,425)(1,915,796)

Loss before income taxes

Net loss-5-

SymBio Pharmaceuticals Limited (4582) Summary of Financial Results [Japanese GAAP] (Non-consolidated)
Results for the third quarter of fiscal year ending December 31, 2016(3) Notes on quarterly financial statements(Notes regarding going concern assumption)
None to be reported.
(Notes regarding significant changes in shareholders’ equity)
During the third quarter of fiscal year ending December 31, 2016, common stock and capital surplus increased by 1,162,500
thousand yen and 1,162,500 thousand yen respectively. This was due to the conversion into new shares in response to theexercise of a portion of the 3rd unsecured convertible bonds with stock acquisition rights. In addition, new shares were issued
upon the exercise of part of the 34th stock acquisition rights, and common stock and capital surplus increased by 342,522
thousand yen and 342,522 thousand yen respectively.
As a result, common stock and capital surplus increased by 1,505,022 thousand yen and 1,505,022 thousand yen
respectively, amounting to 9,835,798 thousand yen and 9,805,798 thousand yen respectively as of September 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 October 1, 2016 to November 11, 2016, a portion of the 3rd unsecured convertible bonds withstock acquisition rights was converted into new shares upon exercise of the rights. The summary of such exercise of the stockacquisition rights is as follows.
Number and type of shares issued:355,450 shares of common stock
Total amount issued:
75,000 thousand yen
Amount of decrease in convertible bonds with stock acquisition rights:
75,000 thousand yen
Amount transferred to common stock:
37,500 thousand yen-6-