EX-99.1 2 kph2017qtr2kt-exhibit991.htm EXHIBIT 99.1 Exhibit


EXHIBIT 99.1

(Translation)

kubotargb200_122a03.jpg

Financial Results for the Second Quarter of the Fiscal Year Ending June 30, 2017 [IFRS] [Consolidated]

August 8, 2017
Company name
Kubota Pharmaceutical Holdings Co., Ltd.
Stock exchange listing
Tokyo Stock Exchange Mothers Market
Code number
4596
URL
www.kubotaholdings.co.jp/en/
Representative
Dr. Ryo Kubota
 
Title: Chairman, President and Chief Executive Officer
Contact
Yasuo Ishikawa, Director of Financial Reporting
 
Japan Office
 
(Telephone: 03-6550-8928)
Scheduled date of quarterly report submission
August 8, 2017
Scheduled date of dividend payment commencement
Supplementary materials for financial results
Yes
Earnings announcement for financial results
No


























1



1. Financial Results for the Six Months Ended June 30, 2017 in FY2017 (Consolidated) (January 1, 2017 to June 30, 2017)
(1) Consolidated Operating Results
(Unit: in millions, % change from the previous fiscal year)
 
Operating Revenue
Loss from operations
Income (loss) before income tax
Net loss attributable to common shareholders
2Q FY2017
¥

NA

¥
(2,071
)
NA

¥
(1,986
)
NA

¥
(1,986
)
NA

2Q FY2016
¥
745

%
¥
(2,471
)

¥
(2,390
)

¥
(2,392
)


(Note) Comprehensive loss: 2Q FY2017 - ¥2,618 million; 2Q FY2016 - ¥5,257 million

(Unit: ¥)
 
 
Basic loss per share
Diluted loss per share
 
 
2Q FY2017
¥
(52.45
)
¥
(52.45
)
 
2Q FY2016
¥
(64.42
)
¥
(64.42
)

(2) Consolidated Financial Position
(Unit: in millions, except for % and per share data)
 
 
Total assets
Net assets
Shareholders’ equity
Shareholders’ equity ratio
Shareholders' equity per share
 
 
As of June 30, 2017
¥
14,714

¥
14,211

¥
14,211

96.6
%
¥
374.26

 
As of December 31, 2016
¥
17,172

¥
16,524

¥
16,524

96.2
%
¥
436.25










2



2. Dividends

(Unit: US$ and ¥)
 
Annual dividend per share
First Quarter
Second Quarter
Third Quarter
Year-end
Total
FY2016
¥

¥

¥

¥

¥0
FY2017
¥

¥

¥

¥

¥0
FY2017 (forecast)
¥

¥

¥

¥

¥0
(Note) Revisions to dividend forecast most recently announced: None.

3. Projected Financial Results for FY2017 (January 1, 2017 to December 31, 2017)
(Unit: ¥ in millions, except for % and per share data)
   
Revenue from collaborations
Loss from operations
Income (loss) before income tax
Net loss
Net loss per share 1
Full Year 2017 Forecast

(4,290
)
(4,180
)
(4,180
)
(110.00
)
Percentage Change (%) - omitted where not meaningful
%
%
%
%
%

(Note) Revisions to projected financial results for FY2017 most recently announced: None.
Instead of the U.S. GAAP -based forecast released on February 14, 2017, this forecast is based on IFRS.

1 - Net income (loss) per share was computed for Full Year 2017 Forecast using 37,972,073 weighted average shares for expected basic and diluted shares outstanding.

Note: Earnings forecast of the Company is based on US dollar amounts. Amounts as to the earnings forecast for FY2017 are converted amounts (Japanese Yen (¥) in thousands except for per share amounts) at the rate of 1 US Dollars = ¥110 which is the rate use to forecast 2017 for the sake of convenience.


4. Others
(1) Changes in significant subsidiaries during the period (changes in specified subsidiaries resulting in a change in scope of consolidation): Not Applicable

(2) Adoption of simplified accounting method or specific accounting methods: None

(3) Changes in accounting policies
(i) Changes caused by revision of accounting standards, etc: None
(ii) Changes other than (i) None

(4) Number of shares issued and outstanding (common stock)

1) Number of shares issued and outstanding as of the end of the reporting period (including treasury stock):


3



Number of Common Shares
As of June 30, 2017
37,972,073

As of December 31, 2016
37,877,705


 
2) Number of shares of treasury stock as of the end of the reporting period:

Number of Treasury Shares
As of June 30, 2017
70

As of December 31, 2016
70



3) Average number of shares outstanding during the reporting period:

Weighted Average Number of Common Shares
2Q FY2017
37,865,504

2Q FY2016
37,135,249



* Implementation status of quarterly review procedures
The quarterly financial report is exempt from quarterly review procedures as stipulated under the Financial Instruments and Exchange Act of Japan.

* Disclaimer Regarding Forward-Looking Statements and Other Items of Note
Effective December 1, 2016, we completed a triangular merger, the Redomicile Transaction, pursuant to which Acucela Inc., the former parent company of Kubota Holdings, the Company, merged with and into Acucela North America Inc., a wholly owned subsidiary of the Company, established on March 24, 2016, as a surviving corporation. Under such transaction, the shares of common stock of the Company were allocated and issued to the shareholders of Acucela Inc. in exchange for the common stock of such company. The Company listed on the Tokyo Stock Exchange Mothers Market on December 6, 2016.

Forecasts and other forward-looking statements included in this report are based on information currently available and certain assumptions that the Company deems reasonable. Actual performance and other results may differ significantly due to various factors.


4



TABLE OF CONTENTS
 






5



1. Qualitative Information for the Second Quarter of FY2017

(1) Qualitative Information on Operating Results
Effective December 1, 2016, we completed a triangular merger, the Redomicile Transaction, pursuant to which Acucela Inc., the former parent company of Kubota Holdings, the Company, merged with and into Acucela North America Inc., a wholly owned subsidiary of the Company, established on March 24, 2016, as a surviving corporation. Under such transaction, the shares of common stock of the Company were allocated and issued to the shareholders of Acucela Inc. in exchange for the common stock of such company.

Comparison of the Six Month Periods Ended June 30, 2017 and June 30, 2016
Revenue from collaborations.
By program, revenues were as follows (in thousands JPY (¥), except for %):
 
Six Months Ended June 30,
 
2016 to 2017
¥ Change
 
2016 to 2017
% Change
 
2017
 
2016
 
Emixustat
¥

 
¥
744,653

 
¥
(744,653
)
 
(100.0
)%
Other

 
339

 
(339
)
 
(100.0
)%
Total
¥

 
¥
744,992

 
¥
(744,992
)
 
(100.0
)%
The decrease in revenue from collaborations for the six months ended June 30, 2017 compared to the same period in 2016 was due to the completion of the Emixustat clinical trial during the year and wind-down activities related to Emixustat following the termination of our collaboration with Otsuka. Wind-down activities related to Emixustat were completed in December 2016.
Our Phase 2b/3 clinical trial results related to Emixustat for the treatment of geographic atrophy was completed in May 2016. We do not expect to generate any revenue from the terminated collaboration with Otsuka related to Emixustat in the future.
Research and development.
Under our strategic plan we anticipate that we may independently develop potential product candidates, and, in the absence of establishing new collaborations, our expenditures on such programs will not be funded by collaborative partners. We expect our total research and development expenses to increase in absolute dollars as we pursue development of our product candidates in multiple indications and potentially execute additional in-licensing transactions, which may result in potential upfront and milestone payments.
By program, our research and development expenses were as follows (in thousands JPY (¥), except for %):
 
Six Months Ended June 30,
 
2016 to 2017
¥ Change
 
2016 to 2017
% Change
 
2017
 
2016
 
Internal Research
¥
870,169

 
¥
682,299

 
¥
187,870

 
27.5
 %
Emixustat
428,915

 
865,691

 
(436,776
)
 
(50.5
)%
Total
¥
1,299,084

 
¥
1,547,990

 
¥
(248,906
)
 
(16.1
)%
Research and development expenses incurred through internal research activities increased for the six months ended June 30, 2017 due to to expenses incurred in the pre-clinical development of ACU-6151 and development of our mobile Health applications or Patient Based Ophthalmology Suite, PBOS. This was offset by an upfront non-refundable fee of ¥560 million paid to YouHealth Eyetech Inc. in the prior year in connection with the option and license agreement for lanosterol technology.
Research and development expense related to clinical programs under the Emixustat Agreement decreased for the six months ended June 30, 2017 compared to same period in 2016, mainly due to the completion of the Phase 2b/3 clinical trial and

6



related wind-down in activities related to such clinical trial following the termination of the Emixustat Agreement in 2016. In 2017, we incurred research and development expense related to the Emixustat clinical programs for Stargardt disease and proliferative diabetic retinopathy.
General and administrative.
The general and administrative expenses were as follows (in thousands JPY (¥), except for %):
 
Six Months Ended June 30,
 
2016 to 2017
¥ Change
 
2016 to 2017
% Change
 
2017
 
2016
 
General and administrative
¥
771,455

 
¥
1,668,262

 
¥
(896,807
)
 
(53.8
)%
General and administrative expenses decreased ¥897 million for the six months ended June 30, 2017 compared to the same period in 2016 primarily due to the following:
we recognised less stock based compensation expense primarily due to fully vested market based awards and accelerated vesting for terminated executives in the prior year in the amount of ¥352 million;
we incurred ¥246 million less of corporate legal expense due to completing the Redomicile Transaction in the prior year;
due to having fewer employees in 2017, thereby decreasing personnel expenses by ¥228 million due to incurring fewer charges in salaries, taxes, other benefits, and travel;
for accounting, compliance, investor relations, consulting, and public relations fees decreased by ¥69 million due to changing of our auditors and the completion of our Otsuka collaboration;
other expenses decreased by ¥16 million; and
we increased expenses in the current year from the Seattle office move by ¥14 million primarily due to the write off of leasehold improvements.

(2) Qualitative Information on Financial Position

Current Assets

Current assets as of June 30, 2017 totaled ¥13,590 million, representing a decrease of ¥1,249 million compared to December 31, 2016.  This change was primarily the result of a decrease in our short-term investment holdings of ¥1,109 million paired with a decrease in trade accounts receivable of ¥213 million due to the ending of our collaboration with Otsuka offset by an increase in cash holdings of ¥135 million.

Non-current Assets

Non-current assets as of June 30, 2017 totaled ¥1,125 million, representing a decrease of ¥1,209 million from December 31, 2016.  This change was the result of transferring a portion of our long-term investment holdings to cash to fund pre-clinical research programs.

Current Liabilities

Current liabilities as of June 30, 2017 totaled ¥390 million, representing a decrease of ¥147 million compared to December 31, 2016.  This change was primarily a decrease in accrued compensation due to the Company having settled most of its severance liabilities related to two former executive officers.

Long-term Liabilities

The Company had ¥113 million in long-term liabilities as of June 30, 2017 which represented our long-term portion of deferred office rent. There were no material changes to our long-term liabilities as of June 30, 2017 compared to December 31, 2016.



Equity

7




Equity as of June 30, 2017 totaled ¥14,211 million, representing a decrease of ¥2,313 million from December 31, 2016.  This change was due to ¥1,986 million of net loss during the period and a decrease of foreign currency translation adjustments attributable to Japanese yen appreciation.

(3) Qualitative Information on Operating Results Forecast

There are no changes to the earnings projections for the year ending December 31, 2017 released on February 14, 2017.

8




2. Quarterly Financial Statements and Other Information
(1) Condensed Consolidated Statements of Financial Position

KUBOTA PHARMACEUTICAL HOLDINGS CO., LTD.
CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(Yen in thousands)
 
The date of transition to IFRS
 
 
 
 
 
January 1, 2016
 
December 31, 2016
 
June 30, 2017
Assets
 
 
 
 
 
Current assets:
 
 
 
 
 
Cash and cash equivalents
¥
613,678

 
¥
1,042,474

 
¥
1,177,421

Trade receivables
739,724

 
212,830

 

Other financial assets
12,921,792

 
13,213,631

 
12,104,581

Other current assets
248,194

 
370,206

 
307,883

Total current assets
14,523,388

 
14,839,141

 
13,589,885

Non-current assets:
 
 
 
 
 
Property, plant and equipment
110,961

 
78,111

 
39,725

Other financial assets
6,618,474

 
2,218,092

 
998,231

Other assets
37,871

 
37,053

 
86,644

Total non-current assets
6,767,306

 
2,333,256

 
1,124,600

Total assets
¥
21,290,694

 
¥
17,172,397

 
¥
14,714,485

Liabilities and equity
 
 
 
 
 
Current liabilities:
 
 
 
 
 
Trade payables
¥
24,966

 
¥
51,132

 
¥
38,815

Accrued liabilities
378,487

 
201,004

 
160,548

Accrued compensation
296,339

 
267,373

 
161,159

Deferred revenue
297,545

 

 

Deferred rent and lease incentives
17,247

 
17,795

 
29,322

Total current liabilities
1,014,584

 
537,304

 
389,844

Non-current liabilities:

 

 

Long-term deferred rent, lease incentives, and others
133,154

 
110,967

 
113,206

Total non-current liabilities
133,154

 
110,967

 
113,206

Total liabilities
1,147,738

 
648,271

 
503,050

Equity:
 
 
 
 
 
Share capital
500

 
19,082

 
52,479

Capital reserve
23,878,351

 
25,056,311

 
25,328,468

Accumulated deficit
(3,735,895
)
 
(7,646,621
)
 
(9,632,526
)
Accumulated other comprehensive loss

 
(904,646
)
 
(1,536,986
)
Total equity attributable to owners of the Company
20,142,956

 
16,524,126

 
14,211,435

Total liabilities and equity
¥
21,290,694

 
¥
17,172,397

 
¥
14,714,485


9



(2) Condensed Consolidated Statements of Operations

KUBOTA PHARMACEUTICAL HOLDINGS CO., LTD.
CONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR LOSS
(Yen in thousands)
(unaudited)
 
Six months ended June 30,
 
2016
 
2017
Operating revenue
¥
744,992

 
¥

Expenses:
 
 
 
Research and development
1,547,990

 
1,299,084

General and administrative
1,668,262

 
771,455

Total expenses
3,216,252

 
2,070,539

Loss from operations
(2,471,260
)
 
(2,070,539
)
Other income (expense), net:
 
 
 
Financial income
79,081

 
79,881

Other income (expense), net
1,804

 
4,925

Total other income, net
80,885

 
84,806

Loss before income tax
(2,390,375
)
 
(1,985,733
)
Income tax expense
(1,995
)
 
(172
)
Net loss
(2,392,370
)
 
(1,985,905
)
Net loss attributable to owners of the Company
¥
(2,392,370
)
 
¥
(1,985,905
)




10



(3) Condensed Consolidated Statements of Comprehensive Loss

KUBOTA PHARMACEUTICAL HOLDINGS CO., LTD.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE PROFIT OR LOSS
(Yen in thousands)

 
Six Months Ended June 30,
 
2016
 
2017
Net loss
¥
(2,392,370
)
 
¥
(1,985,905
)
Other comprehensive income (loss):
 
 
 
Items that may be reclassified to profit or loss
 
 
 
Cumulative translation adjustment, net of tax
(2,865,010
)
 
(632,340
)
Total comprehensive income (loss)
(5,257,380
)
 
(2,618,245
)
Total comprehensive income (loss) attributable to owners of the Company
¥
(5,257,380
)
 
¥
(2,618,245
)

































11



(4) Condensed Consolidated Statements of Shareholders' Equity
KUBOTA PHARMACEUTICAL HOLDINGS CO., LTD.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(Yen in thousands)
 
 
 
 
 
Accumulated
Other
Comprehensive
Loss
 
Accumulated
Deficit
 
Total
 
Share Capital
 
Capital Reserve
 
 
Amount
 
Amount
 
Balance at January 1, 2016
¥
500

 
¥
23,878,351

 
¥

 
¥
(3,735,895
)
 
¥
20,142,956

Share-based compensation

 
594,580

 

 

 
594,580

RSUs withheld for employee payroll taxes

 
(372,059
)
 

 

 
(372,059
)
Common stock issued in connection with stock option exercises (net of ¥352 million withheld for payroll taxes)

 
827,760

 

 

 
827,760

Net loss

 

 

 
(2,392,370
)
 
(2,392,370
)
Cumulative translation adjustment

 

 
(2,865,010
)
 

 
(2,865,010
)
Balance at June 30, 2016
¥
500

 
¥
24,928,632

 
¥
(2,865,010
)
 
¥
(6,128,265
)
 
¥
15,935,857

Share-based compensation

 
189,559

 

 

 
189,559

RSUs withheld for employee payroll taxes

 
(132,597
)
 

 

 
(132,597
)
Common stock issued in connection with stock option exercises (net of ¥20 million withheld for payroll taxes)
18,582

 
74,291

 

 

 
92,873

Excess net tax benefit related to tax provision

 
(3,574
)
 

 

 
(3,574
)
Net loss

 

 

 
(1,518,356
)
 
(1,518,356
)
Cumulative translation adjustment

 

 
1,960,364

 

 
1,960,364

Balance at December 31, 2016
¥
19,082

 
¥
25,056,311

 
¥
(904,646
)
 
¥
(7,646,621
)
 
¥
16,524,126

Share-based compensation

 
295,141

 

 

 
295,141

Common stock issued in connection with stock option exercises
33,397

 
(22,984
)
 

 

 
10,413

Net loss

 

 

 
(1,985,905
)
 
(1,985,905
)
Cumulative translation adjustment

 

 
(632,340
)
 
 
 
(632,340
)
Balance at June 30, 2017
¥
52,479

 
¥
25,328,468

 
¥
(1,536,986
)
 
¥
(9,632,526
)
 
¥
14,211,435




12



(5) Condensed Consolidated Statements of Cash Flows
KUBOTA PHARMACEUTICAL HOLDINGS CO., LTD.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Yen in thousands)

 
Six months ended June 30,
 
2016
 
2017
Cash flows from operating activities
 
 
 
Net loss
¥
(2,392,370
)
 
¥
(1,985,905
)
Adjustments to reconcile net loss to net cash used in operating activities:
 
 
 
Asset impairment

 
55,519

Depreciation
16,614

 
15,912

Share-based compensation
594,580

 
295,141

Amortization, net, of premium/discount on marketable securities
88,896

 
13,901

Net loss on disposal of fixed assets

 
21,158

Changes in operating assets and liabilities:

 

Trade receivables
292,883

 
205,942

Other current assets
(27,995
)
 
(67,685
)
Accounts payable
36,208

 
(9,667
)
Accrued liabilities
(6,150
)
 
(33,291
)
Accrued compensation
(16,708
)
 
(98,009
)
Deferred rent and lease incentives
(7,866
)
 
18,796

Deferred revenue
(269,258
)
 

Other assets
(107,590
)
 
(51,071
)
Net cash used in operating activities
(1,798,756
)
 
(1,619,259
)
Cash flows from investing activities
 
 
 
Interest earned on investments
78,384

 
79,833

Payments for purchase of investment securities
(3,815,543
)
 
(5,765,520
)
Proceeds from maturities of investment securities
5,594,615

 
7,477,823

Net additions to property and equipment
(2,088
)
 
(1,839
)
Net cash provided by investing activities
1,855,368

 
1,790,297

Cash flows from financing activities
 
 
 
Value of equity awards withheld for tax liability
(724,265
)
 

Proceeds from issuance of common stock
1,172,467

 
10,413

Net cash provided by financing activities
448,202

 
10,413

Effect of exchange rate change on cash and cash equivalents
(134,457
)
 
(46,504
)
Increase in cash and cash equivalents
370,357

 
134,947

Cash and cash equivalents—beginning of period
613,678

 
1,042,474

Cash and cash equivalents—end of period
¥
984,035

 
¥
1,177,421





13



(6) Notes on the Consolidated Quarterly Financial Statements

(a) Note regarding Assumption of Going Concern

None noted as of the date of filing of this report.

(b) Note in case of Significant Changes in the Amount of Equity

Not applicable.

1.    First-time Adoption of IFRS

The Company is adopting IFRS for the first time this financial year (January 1, 2017 through December 31, 2017). The date of transition to IFRS is January 1, 2016. Upon transition to IFRS, the Company has adjusted amounts previously reported in its condensed consolidated financial statements prepared in accordance with US GAAP. The effects of the transition from US GAAP to IFRS on the Company’s reported statements of financial position, statements of profit or loss, statements of comprehensive profit or loss and statements of cash flows are explained in the reconciliations and notes that follow.

(1)     IFRS 1 Exemptions

IFRS 1 requires that first-time adopters of IFRS shall apply IFRS retrospectively to prior periods. However, it provides some mandatory exceptions and voluntary exemptions from full retrospective application. Adjustments as a result of the first-time adoption of IFRS and these exemptions are recognised through retained earnings or other components of equity at the date of transition. The Company has taken advantage of the following voluntary exemptions:

(a)
Foreign Currency Translation Adjustments

Cumulative foreign currency translation adjustments are deemed to be zero as of the transition date.

(b)
Share-Based Payment

IFRS 1 permits first-time adopters not to apply IFRS 2, Share-based Payment, to equity instruments that were granted after November 7, 2002 and which vested before the date of transition to IFRS. The Company has taken advantage of this exemption.

(2)    Reconciliation of US GAAP to IFRS and Related Notes

The reconciliations required to be disclosed in the first IFRS financial statements are described in the reconciliations below. "Reclassifications" includes items that do not affect retained earnings and comprehensive loss. "Foreign Currency Translation" shows the difference each reporting period between using the spot convenience rate as reported in our pre-Redomicile Transaction financial statements and the average rate which we are now required to use under IFRS. "IFRS Adjustments" includes items that affect retained earnings and comprehensive loss.

14




(i)    Reconciliation of Equity as of the Transition Date (January 1, 2016)
 
 
 
 
 
 
(Yen in thousands)
US GAAP
US GAAP
Reclassification
IFRS adjustments
IFRS
Note
IFRS
Assets
 
 
 
 
 
Assets
Current assets:
 
 
 
 
 
Current assets:
Cash and cash equivalents
¥
613,678

¥

¥

¥
613,678

 
Cash and cash equivalents
Accounts receivable from collaborations
740,546

(822
)

739,724

A
Trade receivables
Investments
12,895,862


25,930

12,921,792

B
Other financial assets
Prepaid expenses and other current assets
247,372

822


248,194

A
Other current assets
Total current assets
14,497,458


25,930

14,523,388

 
Total current assets
 
 
 
 
 
 
Non-current assets:
Property and equipment, net
110,961



110,961

 
Property, plant and equipment
Long-term investments
6,575,054


43,420

6,618,474

B
Other financial assets
Other assets
37,871



37,871

 
Other assets
Total non-current assets
6,723,886


43,420

6,767,306

 
Total non-current assets
Total assets
21,221,344


69,350

21,290,694

 
Total assets
Liabilities and shareholders’ equity
 
 
 
 
 
Liabilities and equity
Current liabilities:
 
 
 
 
 
Current liabilities:
Accounts payable
24,966



24,966

 
Trade payables
Accrued liabilities
378,487



378,487

 
Accrued liabilities
Accrued compensation
296,339



296,339

 
Accrued compensation
Deferred revenue from collaborations
297,545



297,545

 
Deferred revenue from collaborations
Deferred rent and lease incentives
17,247



17,247

 
Deferred rent and lease incentives
Total current liabilities
1,014,584



1,014,584

 
Total current liabilities
Commitments and contingencies
 
 
 
 
 

 
 
 
 
 
 
Non-current liabilities:
Long-term deferred rent, lease incentives, and others
133,154



133,154

 
Long-term deferred rent, lease incentives, and others
Total long-term liabilities
133,154



133,154

 
Total non-current liabilities
Total liabilities
1,147,738



1,147,738

 
Total liabilities
Shareholders’ equity:
 
 
 
 
 
Equity:
Common stock
23,878,851

(500
)

23,878,351

C
Capital reserve

 
500


500

 
Share capital
Accumulated other comprehensive loss
(69,350
)

69,350


B
Accumulated other comprehensive loss
Accumulated deficit
(3,735,895
)


(3,735,895
)
 
Accumulated deficit
Total shareholders' equity
20,073,606


69,350

20,142,956

 
Total equity attributable to owners of the Company
Total liabilities and shareholders’ equity
¥
21,221,344

¥

¥
69,350

¥
21,290,694

 
Total liabilities and equity

15



Notes to reconciliation of equity as of the date of translation to IFRS (January 1, 2016)

(A)
Reclassifications

Reclassifications: We reclassified less than ¥1 million in non-trade accounts receivable accounts from trade receivables to other current assets as of January 1, 2016.

(B)
Financial instruments

Adjustments: As a result of early adopting IFRS 9, Financial Instruments, issued in 2014, short-term and long-term investments representing corporate debt securities, US government agency securities, commercial paper and certificates of deposit increased as a result of adjusting investments from their fair market value under US GAAP to their amortised cost under IFRS. Short-term investments increased ¥26 million as of January 1, 2016. Long-term investments increased ¥43 million as of January 1, 2016. This increase impacted unrealized gain/(loss) within accumulated other comprehensive loss, a component of equity in the Statement of Financial Position, and net unrealized gain (loss) on securities, net of tax, a component of the Statement of Comprehensive Profit or Loss.


    


16



Reconciliation of Equity as of June 30, 2016
 
 
 
 
 
 
 
(Yen in thousands)
US GAAP
US GAAP
Reclassification
Currency translation
IFRS adjustments
IFRS
Note
IFRS
Assets
 
 
 
 
 
 
Assets
Current assets:
 
 
 
 
 
 
Current assets:
Cash and cash equivalents
¥
984,035

¥

¥

¥

¥
984,035

 
Cash and cash equivalents
Accounts receivable from collaborations
383,442

(3,726
)
 

379,716

A
Trade receivables
Investments
11,611,644



1,065

11,612,709

B
Other financial assets
Prepaid expenses and other current assets
162,083

3,726



165,809

A
Other current assets
Total current assets
13,141,204



1,065

13,142,269

 
Total current assets
 
 
 
 
 
 
 
Non-current assets:
Property and equipment, net
81,401




81,401

 
Property, plant and equipment
Long-term investments
3,314,936



(7,924
)
3,307,012

B
Other financial assets
Other assets
135,224




135,224

 
Other assets
Total non-current assets
3,531,561



(7,924
)
3,523,637

 
Total non-current assets
Total assets
16,672,765



(6,859
)
16,665,906

 
Total assets
Liabilities and shareholders’ equity
 
 
 
 
 
 
Liabilities and equity
Current liabilities:
 
 
 
 
 
 
Current liabilities:
Accounts payable
50,529




50,529

 
Trade payables
Accrued liabilities
316,248




316,248

 
Accrued liabilities
Accrued compensation
242,250




242,250

 
Accrued compensation
Deferred rent and lease incentives
15,539




15,539

 
Deferred rent and lease incentives
Total current liabilities
624,566




624,566

 
Total current liabilities
Commitments and contingencies
 
 
 
 
 
 

 
 
 
 
 
 
 
Non-current liabilities:
Long-term deferred rent, lease incentives, and others
105,483




105,483

 
Long-term deferred rent, lease incentives, and others
Total long-term liabilities
105,483




105,483

 
Total non-current liabilities
Total liabilities
730,049




730,049

 
Total liabilities
Shareholders’ equity:
 
 
 
 
 
 
Equity:
Common stock
21,216,853

(500
)
3,591,558

120,721

24,928,632

C
Capital reserve


500



500

 
Share capital
Accumulated other comprehensive loss
6,895


(2,865,046
)
(6,859
)
(2,865,010
)
B
Accumulated other comprehensive loss
Accumulated deficit
(5,281,032
)

(726,512
)
(120,721
)
(6,128,265
)
C
Accumulated deficit
Total shareholders' equity
15,942,716



(6,859
)
15,935,857

 
Total equity attributable to owners of the Company
Total liabilities and shareholders’ equity
¥
16,672,765

¥

¥

¥
(6,859
)
¥
16,665,906

 
Total liabilities and equity



17



Notes to reconciliation of equity as of June 30, 2016

(A)
Reclassifications

Reclassifications: We reclassified ¥4 million in non-trade accounts receivable accounts from trade receivables to other current assets as of June 30, 2016.

(B)
Financial instruments

Adjustments: As a result of early adopting IFRS 9, Financial Instruments, issued in 2014, short-term and long-term investments representing corporate debt securities, US government agency securities, commercial paper and certificates of deposit decreased as a result of adjusting investments from their fair market value under US GAAP to their amortised cost under IFRS. Short-term investments increased ¥1 million as of as of June 30, 2016. Long-term investments decreased ¥8 million as of June 30, 2016. This decrease impacted unrealized gain/(loss) within accumulated other comprehensive loss, a component of equity in the Statement of Financial Position, and net unrealized gain (loss) on securities, net of tax, a component of the Statement of Comprehensive Profit or Loss.

(C) Share-based compensation

Adjustment: As a result of adopting IFRS 2, Share-based Compensation, the Company changed its expensing of awards from the straight-line method over the entire vesting period to the graded vesting method whereby each installment of an award is treated as a separate grant. When compared to the straight-line method, this often results in additional expense being recorded in earlier periods. For the six months ended June 30, 2016, we recorded additional share-based compensation expense of ¥121 million. This adjustment resulted in a re-allocation of functional expense between the Research and development and General and administrative categories for the periods then ended with a mirroring increase impacting common stock, a component of equity in the Statement of Financial Position.

18



Reconciliation of Profit or Loss and Comprehensive Profit or Loss for the three months ended June 30, 2016

STATEMENT OF PROFIT OR LOSS
 
 
 
 
 
 
 
(Yen in thousands, except per share data)
US GAAP
US GAAP
Currency translation
IFRS adjustments
IFRS
Note
IFRS
Revenue from collaborations
¥
295,763

¥
16,096

¥

¥
311,859

 
Operating revenue
Expenses:
 
 
 
 
 
Expenses:
Research and development
453,010

12,523

16,998

482,531

B
Research and development
General and administrative
676,736

42,194

1,906

720,836

B
General and administrative
Total expenses
1,129,746

54,717

18,904

1,203,367

 
Total expenses
Loss from operations
(833,983
)
(38,621
)
(18,904
)
(891,508
)
 
Loss from operations
Other income (expense), net:
 
 
 
 
 
Other income (expense), net:
Interest income
36,636

1,935


38,571

 
Interest income
Other income (expense), net
(309
)
46


(263
)
 
Other income (expense), net
Total other income, net
36,327

1,981


38,308

 
Total other income, net
Loss before income tax
(797,656
)
(36,640
)
(18,904
)
(853,200
)
 
Loss before income tax
Net loss
¥
(797,656
)
¥
(36,640
)
¥
(18,904
)
¥
(853,200
)
 
Net loss
 
¥
(797,656
)
¥
(36,640
)
¥
(18,904
)
¥
(853,200
)
 
Net loss attributable to owners of the Company
 
 
 
 
 
 
 
Net loss per share
 
 
 
 
 
Net loss per share attributable to owners of the Company
Basic
¥
(21.34
)


¥
(22.83
)
 
Basic
Diluted
¥
(21.34
)


¥
(22.83
)
 
Diluted
 
 
 
 
 
 
 
STATEMENT OF COMPREHENSIVE PROFIT OR LOSS
 
 
 
 
 
 
 
 
 
US GAAP
US GAAP
Currency translation
IFRS adjustments
IFRS
Note
IFRS
Net loss
¥
(797,656
)
¥
(36,640
)
¥
(18,904
)
¥
(853,200
)
 
Net loss
Other comprehensive income (loss):
 
 
 
 
 
Other comprehensive income (loss):
 
 
 
 
 
 
Items that may be reclassified to profit or loss
Net unrealized gain (loss) on securities, net of tax
20,891


(20,891
)

A
Net unrealized gain (loss) on securities, net of tax
Cumulative translation adjustment, net of tax

(1,545,133
)

(1,545,133
)
 
Cumulative translation adjustment, net of tax
Comprehensive loss
¥
(776,765
)
¥
(1,581,773
)
¥
(39,795
)
¥
(2,398,333
)
 
Total comprehensive income (loss)
 
¥
(776,765
)
¥
(1,581,773
)
¥
(39,795
)
¥
(2,398,333
)
 
Total comprehensive income (loss) attributable to owners of the Company


19




Notes to the reconciliation of loss and comprehensive loss for the three months ended June 30, 2016

(A)
Financial instruments

Adjustments: As a result of early adopting IFRS 9, Financial Instruments, issued in 2014, short-term and long-term investments representing corporate debt securities, US government agency securities, commercial paper and certificates of deposit decreased as a result of adjusting investments from their fair market value under US GAAP to their amortised cost under IFRS. This decrease impacted net unrealized gain (loss) on securities, net of tax, a component of the Statement of Comprehensive Profit or Loss by ¥21 million for the three months ended June 30, 2016.

(B)
Share-based compensation

Adjustment: As a result of adopting IFRS 2, Share-based Compensation, the Company changed its expensing of awards from the straight-line method over the entire vesting period to the graded vesting method whereby each installment of an award is treated as a separate grant. When compared to the straight-line method, this often results in additional expense being recorded in earlier periods. For the three months ended June 30, 2016, we recorded additional share-based compensation expense of ¥19 million. This adjustment resulted in a re-allocation of functional expense between the Research and development and General and administrative categories for the periods then ended with a mirroring increase impacting common stock, a component of equity in the Statement of Financial Position.

    

20




Reconciliation of Profit or Loss and Comprehensive Profit or Loss for the six months ended June 30, 2016
STATEMENT OF PROFIT OR LOSS
 
 
 
 
 
 
 
 
(Yen in thousands, except per share data)
US GAAP
US GAAP
Currency translation
IFRS adjustments
IFRS
Note
IFRS
Revenue from collaborations
¥
682,293

¥
62,699

¥

¥
744,992

 
Operating revenue
Expenses:
 
 
 
 
 
Expenses:
Research and development
1,370,864

143,109

34,017

1,547,990

B
Research and development
General and administrative
1,477,375

104,183

86,704

1,668,262

B
General and administrative
Total expenses
2,848,239

247,292

120,721

3,216,252

 
Total expenses
Loss from operations
(2,165,946
)
(184,593
)
(120,721
)
(2,471,260
)
 
Loss from operations
Other income (expense), net:
 
 
 
 
 
Other income (expense), net:
Interest income
72,757

6,324


79,081

 
Financial income
Other income (expense), net
1,544

260


1,804

 
Other income (expense), net
Total other income, net
74,301

6,584


80,885

 
Total other income, net
Loss before income tax
(2,091,645
)
(178,009
)
(120,721
)
(2,390,375
)
 
Loss before income tax
Income tax benefit (expense)
(1,750
)
(245
)

(1,995
)
 
Income tax benefit (expense)
Net loss
¥
(2,093,395
)
¥
(178,254
)
¥
(120,721
)
¥
(2,392,370
)
 
Net loss
 
¥
(2,093,395
)
¥
(178,254
)
¥
(120,721
)
¥
(2,392,370
)
 
Net loss attributable to owners of the Company
 
 
 
 
 
 
 
Net loss per share
 
 
 
 
 
Net loss per share attributable to owners of the Company
Basic
¥
(56.37
)


¥
(64.42
)
 
Basic
Diluted
¥
(56.37
)


¥
(64.42
)
 
Diluted
 
 
 
 
 
 
 
STATEMENT OF COMPREHENSIVE PROFIT OR LOSS
 
 
 
 
 
 
 
 
 
 
US GAAP
US GAAP
Currency translation
IFRS adjustments
IFRS
Note
IFRS
Net loss
¥
(2,093,395
)
¥
(178,254
)
¥
(120,721
)
¥
(2,392,370
)
 
Net loss
Other comprehensive income (loss):
 
 
 
 
 
Other comprehensive income (loss):
 
 
 
 
 
 
Items that may be reclassified to profit or loss
Net unrealized gain (loss) on securities, net of tax
66,068


(66,068
)

A
Net unrealized gain (loss) on securities, net of tax
Cumulative translation adjustment, net of tax

(2,865,010
)

(2,865,010
)
 
Cumulative translation adjustment, net of tax
Comprehensive loss
¥
(2,027,327
)
¥
(3,043,264
)
¥
(186,789
)
¥
(5,257,380
)
 
Total comprehensive income (loss)
 
¥
(2,027,327
)
¥
(3,043,264
)
¥
(186,789
)
¥
(5,257,380
)
 
Total comprehensive income (loss) attributable to owners of the Company







21






Notes to reconciliation of profit or loss and comprehensive profit or loss for the six months ended June 30, 2016

(A)
Financial instruments

Adjustments: As a result of early adopting IFRS 9, Financial Instruments, issued in 2014, short-term and long-term investments representing corporate debt securities, US government agency securities, commercial paper and certificates of deposit decreased as a result of adjusting investments from their fair market value under US GAAP to their amortised cost under IFRS. This decrease impacted net unrealized gain (loss) on securities, net of tax, a component of the Statement of Comprehensive Profit or Loss by ¥66 million for the six months ended June 30, 2016.

(B)
Share-based compensation

Adjustment: As a result of adopting IFRS 2, Share-based Compensation, the Company changed its expensing of awards from the straight-line method over the entire vesting period to the graded vesting method whereby each installment of an award is treated as a separate grant. When compared to the straight-line method, this often results in additional expense being recorded in earlier periods. For the six months ended June 30, 2016, we recorded additional share-based compensation expense of ¥121 million. This adjustment resulted in a re-allocation of functional expense between the Research and development and General and administrative categories for the periods then ended with a mirroring increase impacting common stock, a component of equity in the Statement of Financial Position.


22




Reconciliation of Equity as of December 31, 2016
 
 
 
 
 
 
 
(Yen in thousands)
US GAAP
US GAAP
Reclassification
Currency translation
IFRS adjustments
IFRS
Note
IFRS
Assets
 
 
 
 
 
 
Assets
Current assets:
 
 
 
 
 
 
Current assets:
Cash and cash equivalents
¥
1,042,474

¥

¥

¥

¥
1,042,474

 
Cash and cash equivalents
Accounts receivable from collaborations
239,393

(26,563
)


212,830

A
Trade receivables
Investments
13,205,924



7,707

13,213,631

B
Other financial assets
Prepaid expenses and other current assets
343,643

26,563



370,206

A
Other current assets
Total current assets
14,831,434



7,707

14,839,141

 
Total current assets
 
 
 
 
 
 
 
Non-current assets:
Property and equipment, net
89,643



(11,532
)
78,111

D
Property, plant and equipment
Long-term investments
2,210,404



7,688

2,218,092

B
Other financial assets
Other assets
37,053




37,053

 
Other assets
Total non-current assets
2,337,100



(3,844
)
2,333,256

 
Total non-current assets
Total assets
17,168,534



3,863

17,172,397

 
Total assets
Liabilities and shareholders’ equity
 
 
 
 
 
 
Liabilities and equity
Current liabilities:
 
 
 

 
 
Current liabilities:
Accounts payable
51,132




51,132

 
Trade payables
Accrued liabilities
201,004




201,004

 
Accrued liabilities
Accrued compensation
267,373




267,373

 
Accrued compensation
Deferred rent and lease incentives
17,795




17,795

 
Deferred rent and lease incentives
Total current liabilities
537,304




537,304

 
Total current liabilities
Commitments and contingencies
 
 
 
 
 
 

 
 
 
 
 
 
 
Non-current liabilities:
Long-term deferred rent, lease incentives, and others
110,967




110,967

 
Long-term deferred rent, lease incentives, and others
Total long-term liabilities
110,967




110,967

 
Total non-current liabilities
Total liabilities
648,271




648,271

 
Total liabilities
Shareholders’ equity:
 
 
 
 
 
 
Equity:
Common stock
23,730,843

(19,082
)
1,221,805

122,745

25,056,311

C
Capital reserve


19,082



19,082

 
Share capital
Accumulated other comprehensive loss
285,249


(1,205,290
)
15,395

(904,646
)
B
Accumulated other comprehensive loss
Accumulated deficit
(7,495,829
)

(16,515
)
(134,277
)
(7,646,621
)
C,D
Accumulated deficit
Total shareholders' equity
16,520,263



3,863

16,524,126

 
Total equity attributable to owners of the Company
Total liabilities and shareholders’ equity
¥
17,168,534

¥

¥

¥
3,863

¥
17,172,397

 
Total liabilities and equity

23



Notes to reconciliation of equity as of December 31, 2016

(A)
Reclassifications

Reclassifications: We reclassified ¥27 million in non-trade accounts receivable accounts from trade receivables to other current assets as of December 31, 2016.

(B)
Financial instruments

Adjustments: As a result of early adopting IFRS 9, Financial Instruments, issued in 2014, short-term and long-term investments representing corporate debt securities, US government agency securities, commercial paper and certificates of deposit increased as a result of adjusting investments from their fair market value under US GAAP to their amortised cost under IFRS. Short-term investments increased ¥8 million as of as of December 31, 2016. Long-term investments increased ¥8 million as of December 31, 2016. This decrease impacted unrealized gain/(loss) within accumulated other comprehensive loss, a component of equity in the Statement of Financial Position, and net unrealized gain (loss) on securities, net of tax, a component of the Statement of Comprehensive Profit or Loss.

(C)
Share-based compensation

Adjustment: As a result of adopting IFRS 2, Share-based Compensation, the Company changed its expensing of awards from the straight-line method over the entire vesting period to the graded vesting method whereby each installment of an award is treated as a separate grant. When compared to the straight-line method, this often results in additional expense being recorded in earlier periods. For the year-ended December 31, 2016, we recorded additional share-based compensation expense of ¥123 million. This adjustment resulted in a re-allocation of functional expense between the Research and development and General and administrative categories for the periods then ended with a mirroring increase impacting common stock, a component of equity in the Statement of Financial Position.

Due to recording additional share-based compensation expense for the year-ended December 31, 2016, under IAS 12, Income Taxes, the Company did not assess any material tax impact from windfall or shortfalls when remeasuring awards to their intrinsic value at each reporting period end date.

(D) Website development costs

Adjustment: For the year ended December 31, 2016, the Company decreased Property and equipment, net to de-recognize website development costs required to be recorded as an asset under US GAAP in the amount of ¥12 million. The Company expensed the previously capitalized amount to general and administrative expense.



 



24



Reconciliation of Profit or Loss and Comprehensive Profit or Loss for the year ended December 31, 2016
STATEMENT OF PROFIT OR LOSS
 
 
 
 
 
 
 
 
(Yen in thousands, except per share data)
US GAAP
US GAAP
Currency translation
IFRS adjustments
IFRS
Note
IFRS
Revenue from collaborations
¥
870,198

¥
(23,944
)
¥

¥
846,254

 
Operating revenue
Expenses:
 
 
 
 
 
Expenses:
Research and development
2,370,363

(83,043
)
47,966

2,335,286

B
Research and development
General and administrative
2,620,904

(124,080
)
85,295

2,582,119

B, C
General and administrative
Total expenses
4,991,267

(207,123
)
133,261

4,917,405

 
Total expenses
Loss from operations
(4,121,069
)
183,179

(133,261
)
(4,071,151
)
 
Loss from operations
Other income (expense), net:
 
 
 
 
 
Other income (expense), net:
Interest income
161,254

(7,959
)

153,295

 
Interest income
Other income (expense), net
7,307

(124
)

7,183

 
Other income (expense), net
Total other income, net
168,561

(8,083
)

160,478

 
Total other income, net
Loss before income tax
(3,952,508
)
175,096

(133,261
)
(3,910,673
)
 
Loss before income tax
Income tax benefit (expense)
(41
)
(12
)

(53
)
 
Income tax benefit (expense)
Net loss
¥
(3,952,549
)
¥
175,084

¥
(133,261
)
¥
(3,910,726
)
 
Net loss
 
¥
(3,952,549
)
¥
175,084

¥
(133,261
)
¥
(3,910,726
)
 
Net loss attributable to owners of the Company
 
 
 
 
 
 
 
Net loss per share
 
 
 
 
 
Net loss per share attributable to owners of the Company
Basic
¥
(105.64
)


¥
(104.52
)
 
Basic
Diluted
¥
(105.64
)


¥
(104.52
)
 
Diluted
 
 
 
 
 
 
 
STATEMENT OF COMPREHENSIVE PROFIT OR LOSS
 
 
 
 
 
 
 
 
 
 
US GAAP
US GAAP
Currency translation
IFRS adjustments
IFRS
Note
IFRS
Net loss
¥
(3,952,549
)
¥
175,084

¥
(133,261
)
¥
(3,910,726
)
 
Net loss
Other comprehensive income (loss):
 
 
 
 
 
Other comprehensive income (loss):
 
 
 
 
 
 
Items that may be reclassified to profit or loss
Net unrealized gain (loss) on securities, net of tax
50,783


(50,783
)

A
Net unrealized gain (loss) on securities, net of tax
Cumulative translation adjustment, net of tax
300,296

(1,204,942
)

(904,646
)
 
Cumulative translation adjustment, net of tax
Comprehensive loss
¥
(3,601,470
)
¥
(1,029,858
)
¥
(184,044
)
¥
(4,815,372
)
 
Total comprehensive income (loss)
 
¥
(3,601,470
)
¥
(1,029,858
)
¥
(184,044
)
¥
(4,815,372
)
 
Total comprehensive income (loss) attributable to owners of the Company


25



Notes to reconciliation of profit or loss and comprehensive profit or loss for the year ended December 31, 2016

(A)
Financial instruments

Adjustments: As a result of early adopting IFRS 9, Financial Instruments, issued in 2014, short-term and long-term investments representing corporate debt securities, US government agency securities, commercial paper and certificates of deposit decreased as a result of adjusting investments from their fair market value under US GAAP to their amortised cost under IFRS. This decrease impacted net unrealized gain (loss) on securities, net of tax, a component of the Statement of Comprehensive Profit or Loss by ¥51 million for the year-ended December 31, 2016.

(B)
Share-based compensation

Adjustment: As a result of adopting IFRS 2, Share-based Compensation, the Company changed its expensing of awards from the straight-line method over the entire vesting period to the graded vesting method whereby each installment of an award is treated as a separate grant. When compared to the straight-line method, this often results in additional expense being recorded in earlier periods. For the year-ended December 31, 2016, we recorded additional share-based compensation expense of ¥123 million. This adjustment resulted in a re-allocation of functional expense between the Research and development and General and administrative categories for the periods then ended with a mirroring increase impacting common stock, a component of equity in the Statement of Financial Position.

(C) Website development costs

Adjustment: For the year ended December 31, 2016, the Company increased general and administrative expense to de-recognize capitalised website development costs and related depreciation expense required to be recorded under US GAAP in the amount of ¥10 million.

    
Material items of reconciliation of the consolidated statements of cash flows for the six months ended June 30, 2016 and the year-ended December 31, 2016

There are no material differences between the consolidated statement of cash flows presented under IFRS and the consolidated statement of cash flows presented under US GAAP.


26