English translation

Summary of Financial Results
for the Third Quarter of Fiscal Year Ending December 31, 2017
[Japanese GAAP] (Non-consolidated)
November 10, 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

Contact Person
Scheduled Date to File
Quarterly Report

Director, Finance & Accounting

Kenji Murata
Date of Dividend
Payment (plan)

November 13, 2017

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 2017 (cumulative) (January 1, 2017 to September 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

%

2,416
1,407

71.7
5.6

(3,508)(1,532)－－(3,546)(1,916)－－(3,546)(1,915)－－3Q FY 2017
3Q FY 2016

Quarterly Net Income(Loss) per Share

Diluted Quarterly Net
Income per ShareYen
Yen
3Q FY 2017(72.64)－
3Q FY 2016(51.61)－(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

3Q FY 2017 (as of September 30, 2017)
FY 2016 (as of December 31, 2016)

Total Assets

Net Assets

Millions of yen
5,255
6,878

Millions of yen
2,941
5,484

(Reference) Shareholders’ equity: 3Q FY 2017 (as of September 30, 2017)
FY 2016 (as of December 31, 2016)

Equity Ratio
%
45.6
73.5

2,396 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

English translation

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

3,583% Millions of yen

51.3

Ordinary
Income (Loss)% Millions of yen(3,932)－(Note) Revision of earnings forecasts recently announced:(4,009)Net Income (Loss)Net Income (loss)
per Share% Millions of yen%

Yen(4,009)－(82.16)－

Yes ・ No

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

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 corrections:

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 2017

50,674,624 shares

FY 2016

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

3Q FY 201775 shares

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

3Q FY 2017

48,814,135 shares

3Q FY 201637,123,292 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 3 of the attachment.

English translation

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 …………………………………………………………………..

3

2. Quarterly Financial Statements and Primary Notes ………………………………………………………………………….

4(1) Quarterly balance sheets ………………………………………………………………………….………………………

4(2) Quarterly 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

English translation

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 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”). The Company
obtained marketing approval for first-line treatment of low-grade non-Hodgkin’s lymphoma and mantle cell lymphoma in
December 2016, and for chronic lymphocytic leukemia in August 2016. These are in addition to the indications ofrecurrent/refractory low-grade non-Hodgkin’s lymphoma and mantle cell lymphoma for which marketing approval was
obtained in October 2010. The indication expansion resulted in a significant in-market sales increase of 53.4% year-on-year(NHI price basis). Net sales to Eisai also grew considerably, by 68.0% year-on-year.
In addition to the three already approved indications, the Company continues to pursue label expansion thereby
benefitting patients in need of new therapies and maximizing product value. The Company completed the Phase II clinical
trial for recurrent/refractory intermediate/high-grade non-Hodgkin’s lymphoma (diffuse large B-cell lymphoma) and,through consultation with the Pharmaceuticals and Medical Devices Agency (“PMDA”), began the Phase III clinical trial inAugust 2017.
In addition to the ongoing label expansion initiatives, the Company concluded an exclusive license agreement with Eagle
Pharmaceuticals, Inc. (head office: New Jersey, U.S.) (“Eagle”) in September 2017, under which Eagle licensed to theCompany rights under Eagle’s intellectual property to develop, market, and sell bendamustine hydrochloride(“bendamustine HCl”) ready-to-dilute (“RTD”) and rapid infusion (“RI”) injection products in Japan. This will further
enable the Company to extend the product life until 2031 through patent protection and maximize the value of
TREAKISYM®, while bringing significant benefits to patients and medical professionals. (See press release dated
September 21, 2017 titled “Eagle Pharmaceuticals Licenses Japanese Rights for Bendamustine Hydrochloride Ready-todilute and Rapid Infusion Injection Products to SymBio Pharmaceuticals Limited.”)In addition to the development and expansion of the intravenous formulation product, the Company has been exploring
the development of an oral formulation of TREAKISYM® with a focus on the treatment of solid tumors and autoimmune
diseases, potentially further expanding the business, with an aim to solidify its managerial foundations throughTREAKISYM® as a business platform.
[Anticancer agents: SyB L-1101 (intravenous formulation) and SyB C-1101 (oral formulation), generic name: rigosertib
sodium]The U.S. Licensor Onconova Therapeutics, Inc. (head office: Pennsylvania, U.S.) (“Onconova”) is conducting a global
Phase III clinical trial (with trial sites in more than 10 countries) of the intravenous formulation of rigosertib sodium forhigher-risk myelodysplastic syndromes (HR-MDS) which do not respond to the current standard treatment withhypomethylating agents (“primary HMA failure”) or which relapse after treatment under the current standard of care. The
Company is responsible for the clinical development in Japan and started the domestic trial in December 2015. The
Company completed the first patient enrollment in Japan in July 2016 and patient enrollment is proceeding favorably.
Regarding the oral formulation, delays with the investigational drug by Onconova had prevented patient enrollment in
the domestic Phase I clinical trial for combination therapy with azacitidine (Note) for the target indication of HR-MDS, whichbegan in December 2015. Onconova has recently resumed provision of the investigational drug, and the Company
commenced a new domestic Phase I clinical trial in June 2017 to confirm the safety of high-dose oral rigosertib, which wasadded to the Phase II clinical trial being conducted by Onconova in the U.S. for first-line treatment and recurrent/refractorytreatment of patients with HR-MDS. The Company completed the first patient enrollment in October 2017. After safety is
confirmed through this trial, the Company plans to resume the domestic clinical trial for combination therapy withazacitidine, and to take part in the global Phase III clinical trial for combination therapy with azacitidine for the first-line
treatment of patients with HR-MDS, which is planned by Onconova.
(Note)

Azacitidine (Vidaza®: currently marketed by Nippon Shinyaku Co., Ltd.) was approved in 2011 upon successful
confirmation of extended overall survival for the first time in the Phase III clinical trial for the indication of MDS,
and is currently used as a first-line drug for MDS patients who have complications with hematopoietic stem celltransplantation.

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English translation[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 ofUS-based The Medicines Company (Head Office: New Jersey, U.S.) for an exclusive license to develop and commercialize
SyB P-1501 in Japan. The Company commenced a domestic Phase III clinical trial for SyB P-1501 in June 2016 andcompleted the first patient enrollment in November 2016, with enrollments accumulating. The Company, acting in the bestinterest of patients, determined on April 21, 2017 to temporarily suspend new patient enrollment due to its recently arisingconcern as to the continuity of The Medicines Company’s business regarding the product. At present, the Company
continues discussions with The Medicines Company about the impact on the conduct of this domestic trial andcommercialization of the product. (See press releases “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, “SEC Filing by
The Medicines Company as the Licensor of the Patient-controlled Pain Management Drug SyB P-1501,” dated June 5,
2017, and “Current Status of the Domestic Phase III Clinical Trial of the Patient-controlled Pain Management Drug SyB P1501,” dated August 9, 2017.)[New drug candidates]
The Company continues to actively seek new drug candidates and in-licensing opportunities globally, aiming to expand
both profitability and growth potential over the medium-to-long-term, and discussions with multiple potential licensors are
currently in progress.
In May 2016, the Company established a wholly-owned subsidiary, SymBio Pharma USA, Inc. (Menlo Park, California,
U.S., “SymBio Pharma USA”), as the Company’s planned strategic base for overseas business development. Acquiring
rights to new drug candidates through SymBio Pharma USA as the base of global business will be part of the Company’s
continued transformation into a global specialty biopharmaceutical company with capability to develop and commercialize
new drugs in the U.S., Japan, Europe, and other major global markets.
(ii) Markets outside Japan
SyB L-0501 is also marketed in South Korea, Taiwan and Singapore, and product sales of SyB L-0501 in these countries
progressed favorably at a pace exceeding the Company’s forecasts.
(iii) Business results (cumulative)
Net sales totaled 2,416,625 thousand yen for the third quarter of fiscal year ending December 31, 2017, primarilyreflecting product sales of TREAKISYM®. Overall net sales rose 71.7% year-on-year.
Selling, general and administrative expenses totaled 4,182,845 thousand yen (a year-on-year increase of 108.0%),
including research and development (“R&D”) expenses of 2,711,167 thousand yen (a year-on-year increase of 176.3%)
primarily due to expenses associated with the clinical trial for the intravenous and oral formulations of rigosertib sodium aswell as SyB P-1501, the expenses associated with the licensing of bendamustine HCl RTD and RI injection products, andother selling, general and administrative expenses of 1,471,678 thousand yen (a year-on-year increase of 42.9%).
As a result, an operating loss of 3,508,173 thousand yen was recognized for the third quarter of fiscal year ending
December 31, 2017 (compared to an operating loss of 1,532,310 thousand yen for the third quarter of the previous fiscal
year). In addition, including non-operating expenses totaling 43,144 thousand yen primarily comprised of foreign exchange
losses, ordinary loss totaled 3,546,844 thousand yen (compared to an ordinary loss of 1,916,710 thousand yen for the third
quarter of the previous fiscal year) and net loss totaled 3,546,022 thousand yen (compared to a net loss of 1,915,796
thousand yen for the third 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 September 30, 2017 stood at 5,255,095 thousand yen, a decrease of 1,623,289 thousand yen from theprevious fiscal year end. The decrease was primarily due to decreases of 1,128,037 thousand yen in cash and deposits, 487,471
thousand yen in accounts receivable-trade, 22,207 thousand yen in merchandise and finished goods, 20,639 thousand yen in
prepaid expenses, and 16,488 thousand yen in advances paid, offsetting increases of 40,356 thousand yen in other current assets
and 26,476 thousand yen in software in development.

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English translation

Liabilities stood at 2,314,088 thousand yen, an increase of 920,574 thousand yen from the previous fiscal year end, primarilyreflecting decreases of 450,000 thousand yen in bonds payable and 58,924 thousand yen in accounts payable-trade, offsetting an
increase of 1,433,998 thousand yen in accounts payable-other.
Net assets decreased by 2,543,863 thousand yen from the previous fiscal year end to 2,941,006 thousand yen, due to adecrease of 3,546,022 thousand yen in retained earnings following the recognition of net loss, offsetting the exercise of stockacquisition rights, etc. (including exercise of stock acquisition rights for bonds with convertible bond type stock acquisitionrights).
As a result, the equity ratio decreased by 27.9 percentage points from the previous fiscal year end to 45.6%.
(3) Qualitative information concerning earnings forecasts
The earnings forecast for FY 2017 announced on February 9, 2017 has been revised. For details, please refer to “Notice ofRevision to the Earnings Forecast for FY2017” announced on September 21, 2017.

-3-

English translation

2. Quarterly Financial Statements and Primary Notes(1) Quarterly balance sheets(Unit: thousands of yen)
FY 2016
3Q FY 2017(as of December 31, 2016) (as of September 30, 2017)
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-4-5,719,325
487,471
272,725
79,104
66,46559,9196,685,011

4,591,288－
250,518
58,464
49,977100,276
5,050,524

31,395
43,12974,52429,04135,28264,324

41,985－41,98544,603
26,476
71,0790
11,64965,21476,863
193,373
6,878,384

0
6,438
62,727
69,166
204,570
5,255,095

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

262,935
1,986,508
32,081
31,134
2,312,660

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

－
1,428
1,428
2,314,088

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

10,392,608
10,362,608(18,358,865)(17)
2,396,333
544,672
2,941,006
5,255,095

English translation(2) Quarterly statements of operations (cumulative)(For the third quarter of the fiscal year ending December 31, 2017)(Unit: thousands of yen)
3Q FY 2017
3Q FY 2016
(from January 1, 2017(from January 1, 2016
to September 30, 2017)
to September 30, 2016)
1,407,613
2,416,625
929,195
1,741,953
478,418
674,672
2,010,728
4,182,845(1,532,310)(3,508,173)

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

-5-

5,017
249
1,221
4
6,491

3,058
－
1,339
75
4,473

4
6,756
10,759356,057
17,315
390,891(1,916,710)－
6,747
11,67324,481240
43,144(3,546,844)

4,903
4,903

3,671
3,671

1,139
1,139
(1,912,946)
2,850
2,850
(1,915,796)－－(3,543,172)
2,850
2,850
(3,546,022)

English translation(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, 2017, a portion of the third unsecured bonds withconvertible bond type stock acquisition rights was converted into new shares through the exercise of the rights. In
addition, new shares were issued upon the exercise of part of the 33rd stock acquisition rights, part of the 39th
stock acquisition rights and part of the 42nd stock acquisition rights. As a result, during the third quarter of fiscal
year ending December 31, 2017, common stock and capital surplus increased by 444,310 thousand yen and444,310 thousand yen respectively, amounting to 10,392,608 thousand yen and 10,362,608 thousand yen
respectively as of September 30, 2017.
(Significant subsequent events)
None to be reported.

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