Summary of Financial Results
for the First Half of Fiscal Year Ending December 31, 2018
[Japanese GAAP] (Non-consolidated)
August 07, 2018
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

Corporate Officer, Director of Finance &Accounting and Chief Financial Officer

Kenji Murata

TEL +81-3-5472-1125

Scheduled Date to File
Quarterly ReportAugust 08, 2018

Date of Dividend
Payment (plan)－

Supplementary materials for quarterly financial results:

Yes

No

Holding of quarterly earnings performance review:

Yes

No(Millions of yen – rounded down, unless otherwise stated)

1. Business Results for the First Half of FY 2018 (cumulative) (January 1, 2018 to June 30, 2018)(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

%

1,928
1,786

8.0
47.5

(1,324)(1,235)－－(1,377)(1,268)－－(1,388)(1,266)－－

1H FY 2018
1H FY 2017

Quarterly Net Income(Loss) per Share

Diluted Quarterly Net
Income per ShareYen
Yen
1H FY 2018(23.79)－1H FY 2017(26.09)－(Note) Diluted earnings per share are not shown for the six months ended June 30, 2018 because the company booked a net loss
per share although fully diluted shares existed.
(2) Financial Position

1H FY 2018 (as of June 30, 2018)
FY 2017 (as of December 31, 2017)

Total Assets

Net Assets

Millions of yen
4,845
4,252

Millions of yen
3,479
3,239

(Reference) Shareholders’ equity: 1H FY 2018 (as of June 30, 2018)
FY 2017 (as of December 31, 2017)

Equity Ratio
%
59.5
63.6
2,882 million yen
2,702 million yen

2. Dividends

FY 2017
FY 2018
FY 2018 (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 2018 (January 1, 2018 to December 31, 2018)(Percentages indicate year-on-year changes)

Operating
Income (Loss)

Net Sales
Millions of yen

Full Year

4,201% Millions of yen

22.0

Ordinary
Income (Loss)% Millions of yen(2,981)－(Note) Revision of earnings forecasts recently announced:(3,044)Net Income (Loss)Net Income (Loss)
per Share% Millions of yen%

Yen(3,056)－(50.62)－

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)

1H FY 2018

62,353,224 shares

FY 201754,049,224 shares(ii) Number of shares of treasury stock at theend of the period

1H FY 201875 shares

FY 201775 shares(iii) Average number of shares during the period(cumulative)

1H FY 2018

58,373,567 shares

1H FY 2017

48,538,769 shares*

The quarterly financial results are not subject to quarterly reviews by certified public accountants or an accounting auditor.

*

Explanation regarding the appropriate use of earnings forecasts and other matters
The forecasts and future projections contained herein have been prepared on the basis of rational decisions given theinformation available as of the date of announcement of this document. Actual performance may differ from forecasts for avariety of reasons. Please refer to 1. Qualitative Information Concerning Quarterly Financial Results (3) Qualitative
information concerning earnings forecasts on page 4 of the attachment to this document for cautionary statements concerning
performance forecasts and the conditions that serve as the basis for the forecasts.

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 …………………………………………….……………………..

4(3) Qualitative information concerning earnings forecasts …………………………………………………………………..

4

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

5(1) Quarterly balance sheets ………………………………………………………………………….………………………

5(2) Quarterly statements of income (cumulative) …………………………………………………………………………

7(For the first half of the fiscal year ending December 31, 2018) …………………………………………………………

7(3) Quarterly statement of cash flows…………………………………………………………………………………………

8(4) Notes on quarterly financial statements …………………………………………………………………………………..

9(Notes regarding going concern assumption) ……………………………………………………………………………..

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

9(Significant subsequent events) ……………………………………………………………..……………….………….…

9

1. Qualitative Information Concerning Quarterly Financial Results(1) Qualitative information concerning business results
Progress in the Company’s business for the first half of FY 2018 is as follows:(i) Domestic[Anticancer agent: SyB L-0501 (lyophilized powder formulation), SyB L-1701 (ready-to-dilute (“RTD”)
formulation), SyB L-1702 (rapid infusion (“RI”) formulation) and SyB C-0501 (oral formulation) (genericname: bendamustine hydrochloride, trade name: TREAKISYM®)]
The Company markets TREAKISYM® in Japan through its business partner, Eisai Co., Ltd. (“Eisai”).
The Company obtained marketing approvals 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 approval for the indication of recurrent/refractory low-grade nonHodgkin’s lymphoma and mantle cell lymphoma which was obtained in October 2010. Following thisindication expansion, TREAKISYM® is steadily increasing its market share in the area of first-line
treatment by replacing R-CHOP, the conventional standard treatment, resulting in a significant in-market
sales increase of 22.3% year-on-year (NHI price basis). Net sales to Eisai are progressing as planned.
In addition to the three already-approved indications, the Company has started a Phase III clinical trial
for recurrent/refractory diffuse large B-cell lymphoma (DLBCL) and is currently working on patient
enrollment towards obtaining approval. The trial is in response to serious need at clinics and hospitals as
there is currently no reliable standard treatment. Patient groups have petitioned to the regulatory authorities
for the approval of BR therapy. With a view to providing new therapeutic alternatives and to maximize
product value, the Company began the Phase III clinical trial in August 2017 and is diligently working toaccumulate cases after completing enrollment of the first patient in January 2018.
In addition to these initiatives toward the approval of additional indications, the Company entered into an
exclusive license agreement with Eagle Pharmaceuticals, Inc. (head office: New Jersey, U.S.) (“Eagle”) in
September 2017, under which Eagle licensed to the Company rights under Eagle’s intellectual property todevelop, market, and sell Eagle’s TREAKISYM® liquid formulation (RTD and RI liquid formulations) (Note1) 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 andhealthcare providers. The Company has already consulted with the Pharmaceutical and Medical Devices
Agency regarding details of the application for approval of the RTD formulation and clinical trial designfor the RI formulation, and is preparing for the launch of TREAKISYM® liquid formulation in Japan in
FY2021 or later.
Further, the Company acquired approval for the partial revision to the marketing authorization in July
2018. As a result, TREAKISYM® can now be used in combination with not only rituximab but also
obinutuzumab (Note 2) after its launch for the treatment of low-grade non-Hodgkin’s lymphoma, enabling theCompany to provide patients with a new treatment therapy.
In addition to the development and expansion of the intravenous formulation product, the Company is
exploring the development of an oral formulation of TREAKISYM® with a focus on the treatment of solid
tumors and autoimmune diseases and intends to further expand the business, with an aim to solidify its
business through a platform of TREAKISYM® products. Amid such initiatives, the Company commenced
a Phase I clinical trial for progressive solid tumors in January 2018, with the aim of examining therecommended dosage and administration schedule as well as tolerability and safety of the oral formulationof TREAKISYM®, and identifying potential target tumor types. After completing enrollment of the first
patient in May 2018, the Company is currently working to accumulate cases. Meanwhile, with a view toevaluating the effect of oral administration of TREAKISYM® on the immune system, the Company-1-

concluded a joint research agreement with Keio University in May 2018 to conduct a pre-clinical trial toverify the therapeutic value of this product in the treatment of systemic lupus erythematosus (SLE), a formof autoimmune disease. The pre-clinical trial is currently underway.
(Note 1) RTD and RI are pre-dissolved liquid formulations that differ from the currently available freezedried (“FD”) powder formulation. RTD (ready-to-dilute) will significantly reduce the preparation
time and labor cost for healthcare providers, and RI (rapid infusion) will reduce infusion duration
to 10 minutes from the current 60 minutes, providing significant benefit and value to both patientsand healthcare providers.
(Note 2) Obinutuzumab (Gazyva®, marketed by Chugai Pharmaceutical Co., Ltd.): Like rituximab
recommended by treatment guidelines for non-Hodgkin’s lymphoma in Japan and overseas,
obinutuzumab is a glycoengineered type II anti-20 monoclonal antibody that directly binds toCD20 (a protein expressed on B-cells other than stem cells or plasma cells) on target B-cells to
attack and destroy them along with the body’s immune system.
[Anticancer agents: SyB L-1101 (intravenous formulation) and SyB C-1101 (oral formulation), genericname: rigosertib sodium]
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 20 countries) of the intravenous
formulation of rigosertib for higher-risk myelodysplastic syndromes (HR-MDS) which do not respond tothe current standard treatment with hypomethylating agents, which relapse after treatment under the current
standard of care, or which are intolerant to hypomethylating agents. The Company is responsible forclinical development in Japan and in December 2015 began the trial. 36 patients were enrolled as of June30, 2018, and patient enrollment is proceeding favorably. Based on the results of the interim analysis
completed in January 2018, the Company will continue the trial with a one-time increase in patient
enrollment in accordance with pre-determined statistical criteria. On the basis of these results, theCompany is planning to apply for approval in Japan at the same time as in the U.S. and Europe.
As for the oral formulation of rigosertib, Onconova has been conducting Phase I/II clinical trials in the
U.S. for the target indication of first-line higher-risk myelodysplastic syndromes (MDS) (in combination
with azacitidine (Note 3)), along with a Phase II clinical trial for the target indication of transfusion-dependent
lower-risk MDS. The Company started a domestic Phase I clinical trial in June 2017 to confirm thetolerability and safety of the oral formulation of rigosertib for Japanese patients. The first patient wasenrolled in October 2017 and patient enrollment is proceeding favorably. After completion of this trial, theCompany plans to conduct a clinical trial for combination therapy with azacitidine, to take part in
Onconova’s planned global Phase III clinical trial for combination therapy with azacitidine for the first-line
treatment of patients with higher-risk MDS, and to apply for approval of the oral formulation of rigosertib
in Japan in timing alignment with the U.S. and Europe. With respect to the development for the target
indication of transfusion-dependent lower-risk MDS, the Company will continue to monitor Onconova’s
development activities with a view to participating from Japan.
(Note 3) Azacitidine (Vidaza®: currently marketed by Nippon Shinyaku Co., Ltd.): This drug (forinjection) was approved in 2011 based on results showing extended overall survival for the firsttime in the Phase III clinical trial for the indication of MDS. It is currently used as a first-choice
drug for MDS patients who have difficulties in hematopoietic stem cell transplantation. MDS is apreleukemic state, and decrease in tumor suppressor gene due to excessive methylation of DNA isthought to be related to the disease. Hypomethylating agents such as azacitidine are thought to-2-

suppress progress to leukemia by restoring tumor suppressor gene with a deterrent effect against
methylation of DNA.
[Patient-controlled iontophoretic transdermal system for the short-term management of acute postoperative pain: SyB P-1501]
In October 2015, the Company entered into an agreement with Incline Therapeutics, Inc., a whollyowned subsidiary of US-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, acting in the best interest ofpatients, determined to temporarily suspend new patient enrollment for SyB P-1501 from April 21, 2017
due to its recently arising concern as to the continuity of The Medicines Company’s business regarding the
product.
The Company later initiated arbitration against The Medicines Company on October 11, 2017 under therules of the International Chamber of Commerce, seeking damages of 82 million U.S. dollar(approximately 9.0 billion yen) arising from The Medicines Company’s repudiation of the license
agreement. The Company claims that The Medicines Company failed to provide the Company withadequate assurance of performance of its contractual obligations under the license agreement in light of its
decision to discontinue commercialization activities regarding the product and withdraw from markets in
the U.S. and Europe, and that such failure by The Medicines Company is a material breach of the license
agreement. Furthermore, the Company terminated the license agreement on November 30, 2017, based on
the fact that breach of the license agreement by The Medicines Company was not remedied within the
stipulated time, and terminated the development of SyB P-1501 on February 9, 2018.
Arbitration proceedings against The Medicines Company are still ongoing.
[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 ongoing.
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 baseof 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 the product sales of SyB L0501 in these countries progressed mainly in line with the Company’s forecasts.
(iii) Business results (cumulative)
As a result of the above, net sales totaled 1,928,378 thousand yen for the first half of fiscal year ending
December 31, 2018, primarily reflecting product sales of TREAKISYM®. Overall net sales rose 8.0% yearon-year.
Selling, general and administrative expenses totaled 1,897,937 thousand yen (a year-on-year increase of
8.7%), including research and development (“R&D”) expenses of 838,631 thousand yen (a year-on-year
decrease of 0.1%) primarily due to expenses associated with the clinical trial for the intravenous and oral
formulations of TREAKISYM® as well as the intravenous and oral formulations of rigosertib, and otherselling, general and administrative expenses of 1,059,306 thousand yen (a year-on-year increase of 16.9%).
As a result, an operating loss of 1,324,638 thousand yen was recognized for the first half of fiscal year
ending December 31, 2018 (compared to an operating loss of 1,235,880 thousand yen for the first half of-3-

the previous fiscal year). In addition, including non-operating expenses totaling 53,620 thousand yen
primarily comprised of foreign exchange losses, ordinary loss totaled 1,377,648 thousand yen (compared toan ordinary loss of 1,268,118 thousand yen for the first half of the previous fiscal year) and net loss totaled
1,388,502 thousand yen (compared to a net loss of 1,266,346 thousand yen for the first half of the previous
fiscal year).
Segment information has been omitted as the Company operates within a single segment of thepharmaceutical 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, 2018 stood at 4,845,810 thousand yen, an increase of 593,525 thousand yen fromthe previous fiscal year end. The increase was primarily due to increases of 321,062 thousand yen in accounts
receivable-trade, 199,242 thousand yen in merchandise and finished goods, 102,554 thousand yen in cash anddeposits, 20,533 thousand yen in advances paid, and 16,733 thousand yen in prepaid expenses, offsetting adecrease of 14,139 thousand yen in lease and guarantee deposits.
Liabilities stood at 1,366,293 thousand yen, an increase of 353,411 thousand yen from the previous fiscal year
end, primarily reflecting increases of 278,270 thousand yen in accounts payable-trade and 62,696 thousand yen
in accounts payable-other despite a decrease of 4,483 thousand yen in income taxes payable.
Net assets increased by 240,114 thousand yen from the previous fiscal year end to 3,479,517 thousand yen,
due to increases of 784,194 thousand yen in common stock, 784,194 thousand yen in capital surplus, and 60,227
thousand yen in stock acquisition rights, offsetting a decrease of 1,388,502 thousand yen in retained earnings
following the recognition of net loss.
As a result, the equity ratio fell to 59.5% by 4.1 percentage points from the previous fiscal year end.
(3) Qualitative information concerning earnings forecasts
No revision was made to the earnings forecasts for FY 2018 as of the date of this document.

-4-

2. Quarterly Financial Statements and Primary Notes(1) Quarterly balance sheets

AssetsCurrent assets
Cash and deposits
Accounts receivable-trade
Merchandise and finished goods
Prepaid expenses
Advances paid
Consumption taxes receivable
Other
Total current assets
Non-current assets
Property, plant and equipment
Buildings, net
Tools, furniture and fixtures, net
Construction in progress
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
Provision for retirement benefits
Total non-current liabilities
Total liabilities
Net assets
Shareholders’ equity
Common stock
Capital surplus
Retained earnings (accumulated deficits)-5-

FY 2017(as of December 31, 2017)(Unit: thousands of yen)
1H FY 2018(as of June 30, 2018)

2,947,059
489,874
362,51473,72018,76098,44046,152
4,036,522

3,049,613
810,936
561,757
90,45439,294
66,446
26,612
4,645,115

28,48618,32264
46,87338,401
23,894－62,29565,583
3,295
68,87857,653－57,6530
14,20985,799100,008
215,761
4,252,284

0
9,085
71,66080,746200,695
4,845,810

604,382
330,867
54,813
21,427
1,011,490

882,652
393,563
50,32938,227
1,364,773

1,392
1,392
1,012,882

1,520
1,520
1,366,293

10,761,676
10,731,676(18,790,705)

11,545,871
11,515,871(20,179,207)

Treasury stock
Total shareholders’ equity
Stock acquisition rights
Total net assets
Total liabilities and net assets(17)
2,702,629
536,772
3,239,402
4,252,284

-6-

(17)
2,882,516
597,000
3,479,517
4,845,810

(2) Quarterly statements of income (cumulative)(For the first half of the fiscal year ending December 31, 2018)

Net sales
Cost of goods sold
Gross profit
Selling, general and administrative expenses
Operating loss
Non-operating income
Interest income
Interest on refund
Other
Total non-operating income
Non-operating 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-7-

1H FY 2017(from January 1, 2017
to June 30, 2017)
1,786,005
1,276,110
509,894
1,745,774(1,235,880)(Unit: thousands of yen)
1H FY 2018(from January 1, 2018
to June 30, 2018)
1,928,378
1,355,079
573,299
1,897,937(1,324,638)

1,585
－
70
1,656

439
116
54
609

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

5,504
19,11429,002－53,620(1,377,648)

3,671
3,671

876
876

－
－
(1,264,446)
1,900
1,900
(1,266,346)

9,829
9,829
(1,386,602)
1,900
1,900
(1,388,502)

(3) Quarterly statement of cash flow
(Unit: thousands of yen)
1H FY 2017
1H FY 2018(from January 1, 2017(from January 1, 2018)
to June 30, 2017)
to June 30, 2018)
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
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
Income taxes paid
Net cash provided by (used in) operating activities
Net cash provided by (used in) investing activities
Purchase of property, plant and equipment
Purchase of intangible assets
Proceeds from collection of lease and guarantee
deposits
Net cash provided by (used in) investing activities
Net cash provided by (used in) financing activities
Proceeds from issuance of stock resulting fromexercise of stock acquisition rights
Proceeds from issuance of stock acquisition rights
Payments for issuance of common stock
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 year
Cash and cash equivalents at the end of the year-8-

(1,264,446)
14,365
67,120(28)(1,585)29,126
4,504
2,079
ሺ3,671)－
182,505(159,842)
ሺ5,953)
28,979
ሺ5,052)(47,868)
2,365
237,785
71,6102,118
309(845,577)
1,625(1,900)(845,852)(1,386,602)
16,91564,636128(439)
29,8705,504
19,114(876)
9,829(321,062)(199,242)(22,238)(20,533)
31,994
31,614
5,123
278,270
61,233241745(1,395,772)
439(1,900)(1,397,232)(10,662)(13,149)(27,834)(3,530)3,065

13,747(20,747)(17,617)

63,529

1,541,756－(2,079)61,45023,100(17,582)
1,547,274(29,126)(29,870)(834,275)
5,719,325
4,885,050

102,554
2,947,059
3,049,613

(4) Notes on quarterly financial statements(Notes regarding going concern assumption)
None to be reported.
(Notes regarding significant changes in shareholders’ equity)
During the first half of fiscal year ending December 31, 2018, new shares were issued upon theexercise of part of the 33rd, 36th, 42nd, and 45th stock acquisition rights. As a result, during the firsthalf of fiscal year ending December 31, 2018, common stock and capital surplus increased by
784,194 thousand yen and 784,194 thousand yen respectively, amounting to 11,545,871 thousand
yen and 11,515,871 thousand yen respectively as of June 30, 2018.
(Significant subsequent events)
None to be reported.

-9-