English translation

Summary of Financial Results
for the Second Quarter of Fiscal Year Ending December 31, 2017
[Japanese GAAP] (Non-consolidated)
August 3, 2017
Company Name

SymBio Pharmaceuticals Limited

Listing: Tokyo Stock 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

Kenji Murata
Date of Dividend
Payment (plan)

August 4, 2017

TEL +81-3-5472-1125－

Supplementary materials for quarterly financial results:

Yes

No

Holding of quarterly earnings performance review:Yes

No (For securities analysts and institutional investors)(Millions of yen – rounded down, unless otherwise stated)

1. Business Results for the Second Quarter of FY 2017 (cumulative) (January 1, 2017 to June 30, 2017)(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

%

1,786
1,210

47.5
24.0

(1,235)(819)－－(1,268)(1,177)－－(1,266)(1,175)－－2Q FY 2017
2Q FY 2016

Quarterly Net Income(loss) per share

Diluted Quarterly Net
Income per shareYen
Yen
2Q FY 2017(26.09)－2Q FY 2016(33.93)－(Note) Diluted quarterly net income per share is not stated above due to quarterly net loss per share, despite the potential dilution of shares.
(2) Financial Position

2Q FY 2017 (as of June 30, 2017)
FY 2016 (as of December 31, 2016)

Total Assets

Net Assets

Millions of yen
6,048
6,878

Millions of yen
4,795
5,484

(Reference) Shareholders’ equity: 2Q FY 2017 (as of June 30, 2017)
FY 2016 (as of December 31, 2016)

Equity Ratio
%
71.2
73.5

4,305 million yen
5,053 million yen

2. Dividends

FY 2016
FY 2017
FY 2017 (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 2017 (January 1, 2017 to December 31, 2017)(Percentages indicate year-on-year changes)

Operating
Income (loss)

Net Sales
Millions of yen

Full Year

2,903% Millions of yen

22.6

Ordinary
Income (loss)% Millions of yen(3,238)－(Note) Revision of earnings forecasts recently announced:

Notes:(1) Application of special accounting treatment in
preparation of quarterly financial reports:(3,303)Net Income (loss)

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

Yen(3,306)－(71.07)－

Yes ・ NoYes ・ 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 corrections:

Yes ・ No

(3) Number of shares outstanding (common stock)(i) Number of shares outstanding at the end of
the period (including treasury stock)

2Q FY 2017

48,983,324 shares

FY 2016

46,530,824 shares(ii) Number of shares of treasury stock at theend of the period

2Q FY 201775 shares

FY 201675 shares(iii) Average number of shares during the period(cumulative)

2Q FY 2017

48,538,769 shares

2Q FY 2016

34,643,145 shares* The quarterly financial statements are not subject to quarterly reviews.
* Explanation regarding the appropriate use of earnings forecasts and other matters
All forecasts presented in this document, including the outlook on earnings, 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, (3) Qualitative information concerning earnings forecasts,” onPage 2 of the attachment.

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 and Primary Notes ………………………………………………………………………….

3(1) Quarterly balance sheets …………………………………………………………………………………………………

3(2) Quarterly statements of operations (cumulative) …………………………………………………………………………

4(3) Quarterly statements of cash flow……………………………………………………..……………….…………………

5(4) 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. Qualitative Information Concerning Quarterly Financial Results(1) Qualitative information concerning business results
Progress in the Company’s business for the second quarter of FY 2017 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 new
indications of the first-line treatment of low-grade non-Hodgkin’s lymphoma and mantle cell lymphoma, for which theCompany obtained marketing approval in December 2016 and chronic lymphocytic leukemia for which it obtained
marketing approval in August 2016, in addition to the indication of recurrent/refractory low-grade non-Hodgkin’s
lymphoma and mantle cell lymphoma (for which marketing approval was obtained in October 2010). By expanding theindications for this agent, in-market sales increased significantly by 42.9% year-on-year (NHI price basis) and net sales toEisai also grew considerably by 44.6% year-on-year.
In addition to the above three indications of this agent for which approval has already been obtained, the Company
continues to pursue approval for the fourth indication for patients who need new therapies and for maximizing the productvalue. Regarding the indication of recurrent/refractory intermediate/high-grade non-Hodgkin’s lymphoma (diffuse large Bcell lymphoma), for which the Phase II clinical trial has been completed, the Company, in response to strong medical needs,
is making preparations through consultation with the Pharmaceuticals and Medical Devices Agency (“PMDA”), for thePhase III clinical trial for approval of an additional indication.
Furthermore, in order to solidify its management foundations, the Company will utilize TREAKISYM® as a firm base forits business activities, and to this end it is promoting the development of the oral formulation of TREAKISYM®, in addition
to the intravenous formulation which is currently being developed and marketed, with a focus on the treatment of solid
tumors and autoimmune diseases, considering the possibility of further expanding its business.
[Anticancer agents: SyB L-1101 (intravenous formulation) and SyB C-1101 (oral formulation), generic name: rigosertib
sodium]For the global Phase III clinical trial of the intravenous formulation of rigosertib sodium conducted by Onconova
Therapeutics, Inc. (Head office: Pennsylvania, U.S.; “Onconova”), the U.S. Licensor, the Company is in charge of theclinical development in Japan and started the domestic trial in December 2015. This trial is conducted with clinical trialsites in more than ten countries worldwide, for higher-risk myelodysplastic syndromes (HR-MDS) which do not respond tothe current standard treatment with hypomethylating agents (“primary HMA failure”) or which relapse after treatment under
the current standard of care. The Company completed the first patient enrollment in Japan in July 2016, and currently theaccumulation of enrollments is proceeding favorably.
Regarding the oral formulation of rigosertib sodium, in the domestic Phase I clinical trial in combination with azacitidine(Note) for the target indication of HR-MDS, which began in December 2015, the provision of the investigational drug by
Onconova had been delayed, and as a result, patient enrollment had not made any progress. However, provision of theinvestigational drug by Onconova has recently resumed, and the Company has commenced a new domestic Phase I clinical
trial to confirm the safety of high-dose oral rigosertib, which was added to the Phase II clinical trial being conducted by
Onconova in the U.S. for the first-line treatment and recurrent/refractory treatment of patients with HR-MDS. Once thesafety is confirmed by such trial, the Company intends to promptly resume the clinical trial in combination with azacitidine,and to take part in the global Phase III clinical trial in combination with azacitidine in the first-line treatment of patientswith HR-MDS, which is planned by Onconova.
(Note)

About azacitidine (Vidaza®: currently marketed by Nippon Shinyaku Co., Ltd.): This drug was approved in 2011
upon successful confirmation of extended overall survival for the first time in the Phase III clinical trial for theindication of MDS, and 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 post-operative 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 SyB P-1501 in Japan. The Company commenced a domestic Phase III clinical trial for SyB P-1501 in June
2016 and completed the first patient enrollment in November 2016, with enrollments accumulating. However, theCompany, acting in the best interest of patients, decided on April 21, 2017 to temporarily suspend new patient enrollment in-1-

the trial due to its recently arising concern as to the continuity of The Medicines Company’s business regarding the product.
(Details are stated in the released announcements, “Temporary Suspension of New Patient Enrollment in the Domestic
Phase III Clinical Trial of the Patient-controlled Pain Management Drug “SyB P-1501” dated May 11, 2017 and “SEC
Filing by The Medicines Company as the Licensor of the Patient-controlled Pain Management Drug “SyB P-1501” dated
June 5, 2017.)[New drug candidates]
The Company continues with search and evaluation activities to acquire license rights of new drug candidates in global
terms, aiming to grow into a biopharmaceutical company with both profitability and growth potential, always from a
medium-to-long-term perspective, and 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 through SymBio Pharma USA as
the base of global business, the Company will continue its transformation into a global specialty biopharmaceuticalcompany 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
progressed essentially as planned.
(iii) Business results (cumulative)
As a result of the above, net sales totaled 1,786,005 thousand yen for the second quarter of fiscal year ending December
31, 2017, primarily reflecting product sales of TREAKISYM®. Accordingly, overall net sales rose 47.5% year-on-year.
Selling, general and administrative expenses totaled 1,745,774 thousand yen (a year-on-year increase of 42.5%),
including research and development (“R&D”) expenses of 839,657 thousand yen (a year-on-year increase of 62.0%)
primarily due to expenses associated with the clinical trial for the intravenous and oral formulations of rigosertib sodium aswell as SyB P-1501, and other selling, general and administrative expenses of 906,117 thousand yen (a year-on-yearincrease of 28.3%).
As a result, operating loss of 1,235,880 thousand yen was recognized for the second quarter of fiscal year ending
December 31, 2017 (operating loss of 819,937 thousand yen for the second quarter of the previous fiscal year). In addition,
mainly because the Company recorded non-operating expenses totaling 33,894 thousand yen primarily comprising foreignexchange losses, ordinary loss totaled 1,268,118 thousand yen (ordinary loss of 1,177,202 thousand yen for the second
quarter of the previous fiscal year) and net loss totaled 1,266,346 thousand yen (net loss of 1,175,338 thousand yen for thesecond 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, 2017 stood at 6,048,080 thousand yen, a decrease of 830,304 thousand yen from the previous fiscal
year end. This was primarily due to decreases of 834,275 thousand yen in cash and deposits, 182,505 thousand yen in accounts
receivable-trade and 28,979 thousand yen in advances paid, offsetting increases of 159,842 thousand yen in merchandise andfinished goods, 52,881 thousand yen in other current assets and 20,172 thousand yen in software in progress.
Liabilities stood at 1,252,578 thousand yen, a decrease of 140,935 thousand yen from the previous fiscal year end, primarilyreflecting a decrease of 450,000 thousand yen in bonds payable, offsetting increases of 237,785 thousand yen in accounts
payable-trade and 67,970 thousand yen in accounts payable-other.
Net assets decreased by 689,368 thousand yen from the previous fiscal year end to 4,795,501 thousand yen, due to a decreaseof 1,266,346 thousand yen in retained earnings following the recognition of net loss, offsetting the exercise of stock acquisitionrights, etc. (including exercise of stock acquisition rights for bonds with convertible bond type stock acquisition rights).
As a result, the equity ratio decreased by 2.3 percentage points from the previous fiscal year end to 71.2%.
(3) Qualitative information concerning earnings forecasts
No revision was made to the earnings forecasts for FY 2017 as of the date of this document.

-2-2. Quarterly Financial Statements and Primary Notes(1) Quarterly balance sheets
FY 2016(as of December 31, 2016)(Unit: thousands of yen)
2Q FY 2017(as of June 30, 2017)

5,719,325
487,471
272,725
79,104
66,46559,9196,685,011

4,885,050
304,965
432,567
80,55337,486112,801
5,853,424

31,395
43,12974,52429,72237,857
67,58041,985－41,98534,812
20,172
54,984

0
11,64965,21476,863
193,373
6,878,384

0
9,283
62,80772,091
194,656
6,048,080

321,860
552,510
36,586
31,161
942,118

559,646
620,480
39,35731,7261,251,210

450,000
1,396
451,396
1,393,514

－
1,368
1,368
1,252,578

9,948,298
9,918,298(14,812,843)(17)
5,053,735
431,135
5,484,870
6,878,384

10,207,544
10,177,544(16,079,190)(17)
4,305,881
489,620
4,795,501
6,048,080

AssetsCurrent assets
Cash and deposits
Accounts receivable-trade
Merchandise and finished goods
Prepaid expenses
Advances paid
Other
Total current assets
Non-current assets
Property, plant and equipment
Buildings, net
Tools, furniture and fixtures, net
Total property, plant and equipment
Intangible assets
Software
Software in progress
Total intangible assets
Investments and other assets
Shares of subsidiaries
Long-term prepaid expenses
Lease and guarantee deposits
Total investments and other assets
Total non-current assets
Total assets
Liabilities
Current liabilities
Accounts payable-trade
Accounts payable-other
Income taxes payable
Other
Total current liabilities
Non-current liabilities
Bonds payable
Provision for retirement benefits
Total non-current liabilities
Total liabilities
Net assets
Shareholders’ equity
Common stock
Capital surplus
Retained earnings (accumulated deficits)
Treasury stock
Total shareholders’ equity
Stock acquisition rights
Total net assets
Total liabilities and net assets-3-(2) Quarterly statements of operations (cumulative)(For the second quarter of the fiscal year ending December 31, 2017)(Unit: thousands of yen)
2Q FY 2017
2Q FY 2016
(from January 1, 2017(from January 1, 2016
to June 30, 2017)
to June 30, 2016)
1,210,725
1,786,005
805,933
1,276,110
404,792
509,894
1,224,729
1,745,774(819,937)(1,235,880)

Net sales
Cost of goods sold
Gross profit
Selling, general and administrative expenses
Operating loss
Non-operating income
Interest income
Interest on securities
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 loss
Loss before income taxes
Income taxes-current
Total income taxes
Net loss

-4-

2,973
81
4
3,058

1,585
－
70
1,656

3
4,487
7,497
330,411
17,925360,324(1,177,202)

－
4,504
2,079
27,26645
33,894(1,268,118)

4,903
4,903

3,671
3,671

1,139
1,139
(1,173,438)
1,900
1,900
(1,175,338)－－(1,264,446)
1,900
1,900
(1,266,346)

(3) Quarterly statements of cash flow
(Unit: thousands of yen)
2Q FY 2017(from January 1, 2017
to June 30, 2017)

2Q FY 2016
(from January 1, 2016
to June 30, 2016)
Net cash provided by (used in) operating activities
Loss before income taxes
Depreciation
Share-based compensation expenses
Increase (decrease) in provision for retirement benefits
Interest income
Interest expenses
Foreign exchange losses (gains)
Commission fees
Stock issuance costs
Gain on reversal of stock acquisition rights
Loss on retirement of non-current assets
Decrease (increase) in accounts receivable-trade
Decrease (increase) in inventories
Decrease (increase) in prepaid expenses
Decrease (increase) in advances paid
Decrease (increase) in consumption taxes receivable
Decrease (increase) in other current assets
Decrease (increase) in long-term prepaid expenses
Increase (decrease) in accounts payable-trade
Increase (decrease) in accounts payable-other
Increase (decrease) in other current liabilities
Other
SubtotalInterest and dividends income received
Interest expenses paid
Income taxes paid
Net cash provided by (used in) operating activities
Net cash provided by (used in) investing activities
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-5-(1,173,438)
12,70465,039(199)(3,054)
3359,903
4,487
7,497(4,903)
1,139(43,601)
133,029(28,817)
25,569－469
323(110,837)
9,193
13,535
17,925(714,030)
2,868(3)(1,900)(713,064)(1,264,446)
14,365
67,120(28)(1,585)－29,126
4,504
2,079(3,671)－
182,505(159,842)(5,953)
28,979(5,052)(47,868)
2,365
237,785
71,6102,118
309(845,577)
1,625－(1,900)(845,852)(0)(18,939)(1,250)(218)－(10,662)(13,149)
－

－

3,065

(20,407)(20,747)

2Q FY 2016
(from January 1, 2016
to June 30, 2016)
Net cash provided by (used in) financing activities
Proceeds from issuance of stock resulting from exerciseof stock acquisition rights
Proceeds from issuance of bonds with rights
Proceeds from issuance of stock acquisition rights
Payments for issuance of common stock
Repayments for lease obligations
Other payments
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-6-(Unit: thousands of yen)
2Q FY 2017(from January 1, 2017
to June 30, 2017)

678,018

63,5293,000,000
9,776(5,659)(349)(17,925)
3,663,859－－(2,079)－－61,450(359,903)(29,126)

2,570,483
4,261,438
6,831,922(834,275)
5,719,325
4,885,050

(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, 2017, a portion of the third unsecured bonds
with convertible bond type stock acquisition rights was converted into new shares through the exercise of therights. In addition, new shares were issued upon the exercise of part of the 33rd stock acquisition rights and partof the 39th stock acquisition rights. As a result, during the second quarter of fiscal year ending December 31,
2017, common stock and capital surplus increased by 259,246 thousand yen and 259,246 thousand yen
respectively, amounting to 10,207,544 thousand yen and 10,177,544 thousand yen respectively as of June 30,
2017.
(Significant subsequent events)
None to be reported.

-7-