EX-99.1 19 d608344dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

1. Condensed Interim Consolidated Financial Statements

(1) Condensed Interim Consolidated Statements of Income (Unaudited)

 

     JPY (millions)  
          Six months period ended
September 30,
         Three months period ended
September 30,
 
     Note    2017     2018     Note    2017     2018  

Revenue

   4      881,416       880,611     4      433,177       430,777  

Cost of sales

        (242,741     (231,341        (121,873     (110,751

Selling, general and administrative expenses

        (297,263     (293,783        (151,396     (148,755

Research and development expenses

        (155,096     (151,432        (79,408     (79,466

Amortization and impairment losses on intangible assets associated with products

        (56,885     (48,288        (24,395     (24,267

Other operating income

   5      136,935       32,331          5,635       23,047  

Other operating expenses

   6      (32,017     (16,142        (22,366     (17,499
     

 

 

   

 

 

      

 

 

   

 

 

 

Operating profit

        234,349       171,956          39,374       73,086  

Finance income

        14,116       4,411          619       2,469  

Finance expenses

        (15,983     (19,618        (6,019     (9,109

Share of profit of investments accounted for using the equity method

        506       4,031          772       471  
     

 

 

   

 

 

      

 

 

   

 

 

 

Profit before tax

        232,988       160,780          34,746       66,917  

Income tax expenses

        (60,318     (34,291        (7,065     (18,508
     

 

 

   

 

 

      

 

 

   

 

 

 

Net profit for the period

        172,670       126,489          27,681       48,409  
     

 

 

   

 

 

      

 

 

   

 

 

 

Attributable to:

              

Owners of the Company

        172,816       126,668          28,027       48,426  

Non-controlling interests

        (146     (179        (346     (17
     

 

 

   

 

 

      

 

 

   

 

 

 

Net profit for the period

        172,670       126,489          27,681       48,409  
     

 

 

   

 

 

      

 

 

   

 

 

 

Earnings per share (JPY)

              

Basic earnings per share

   7      221.43       161.76     7      35.89       61.73  

Diluted earnings per share

   7      219.98       160.93     7      35.67       61.48  

See accompanying notes to condensed interim consolidated financial statements.

 

1


(2) Condensed Interim Consolidated Statements of Income and Other Comprehensive Income (Unaudited)

 

    JPY (millions)  
          Six months period ended
September 30,
          Three months period ended
September 30,
 
    Note     2017     2018     Note     2017     2018  

Net profit for the period

      172,670       126,489         27,681       48,409  

Other comprehensive income:

           

Items that will not be reclassified to profit or loss:

           

Changes in fair value of financial assets measured at fair value through other comprehensive income

      —         13,008         —         9,279  

Re-measurement gain (loss) on defined benefit plans

      688       (163       10       802  
   

 

 

   

 

 

     

 

 

   

 

 

 
      688       12,845         10       10,081  

Items to be reclassified subsequently to profit or loss:

           

Exchange differences on translation of foreign operations

      86,421       66,680         32,618       60,718  

Net changes on revaluation of available-for-sale financial assets

      8,113       —           3,778       —    

Cash flow hedges

      1,523       1,704         724       (884

Hedging cost

      691       (152       161       (199

Share of other comprehensive income (loss) of investments accounted for using the equity method

      36       (171       18       (81
   

 

 

   

 

 

     

 

 

   

 

 

 
      96,784       68,061         37,299       59,554  
   

 

 

   

 

 

     

 

 

   

 

 

 

Other comprehensive income for the period, net of tax

      97,472       80,906         37,309       69,635  
   

 

 

   

 

 

     

 

 

   

 

 

 

Total comprehensive income for the period

      270,142       207,395         64,990       118,044  
   

 

 

   

 

 

     

 

 

   

 

 

 

Attributable to:

           

Owners of the Company

      269,943       207,742         65,142       118,148  

Non-controlling interests

      199       (347       (152     (104
   

 

 

   

 

 

     

 

 

   

 

 

 

Total comprehensive income for the period

      270,142       207,395         64,990       118,044  
   

 

 

   

 

 

     

 

 

   

 

 

 

See accompanying notes to condensed interim consolidated financial statements.

 

2


(3) Condensed Interim Consolidated Statements of Financial Position (Unaudited)

 

            JPY (millions)  
     Note      As of March 31, 2018      As of September 30, 2018  

ASSETS

        

NON-CURRENT ASSETS:

        

Property, plant and equipment

        536,801        533,088  

Goodwill

        1,029,248        1,085,706  

Intangible assets

        1,014,264        1,067,172  

Investments accounted for using the equity method

        107,949        115,174  

Other financial assets

        196,436        221,210  

Other non-current assets

        77,977        90,522  

Deferred tax assets

        64,980        54,024  
     

 

 

    

 

 

 

Total non-current assets

        3,027,655        3,166,896  
     

 

 

    

 

 

 

CURRENT ASSETS:

        

Inventories

        212,944        233,304  

Trade and other receivables

        420,247        461,436  

Other financial assets

        80,646        20,281  

Income tax receivables

        8,545        7,483  

Other current assets

        57,912        68,130  

Cash and cash equivalents

        294,522        317,080  

Assets held for sale

     12        3,992        229  
     

 

 

    

 

 

 

Total current assets

        1,078,808        1,107,943  
     

 

 

    

 

 

 

Total assets

        4,106,463        4,274,839  
     

 

 

    

 

 

 

 

3


            JPY (millions)  
     Note      As of March 31, 2018     As of September 30, 2018  

LIABILITIES AND EQUITY

       

LIABILITIES

       

NON-CURRENT LIABILITIES:

       

Bonds and loans

        985,644       879,621  

Other financial liabilities

        91,223       79,619  

Net defined benefit liabilities

        87,611       88,822  

Provisions

        28,042       23,912  

Other non-current liabilities

        68,300       65,517  

Deferred tax liabilities

        90,725       120,995  
     

 

 

   

 

 

 

Total non-current liabilities

        1,351,545       1,258,486  
     

 

 

   

 

 

 

CURRENT LIABILITIES:

       

Bonds and loans

        18       120,913  

Trade and other payables

        240,259       225,752  

Other financial liabilities

        29,613       41,310  

Accrued income taxes

        67,694       61,296  

Provisions

        132,781       144,367  

Other current liabilities

        263,930       250,554  

Liabilities held for sale

     12        3,214       —    
     

 

 

   

 

 

 

Total current liabilities

        737,509       844,192  
     

 

 

   

 

 

 

Total liabilities

        2,089,054       2,102,678  
     

 

 

   

 

 

 

EQUITY

       

Share capital

        77,914       77,942  

Share premium

        90,740       81,777  

Treasury shares

        (74,373     (57,167

Retained earnings

        1,557,307       1,648,094  

Other components of equity

        350,631       417,712  

Other comprehensive income related to assets held for sale

        (4,795     —    
     

 

 

   

 

 

 

Equity attributable to owners of the Company

        1,997,424       2,168,358  
     

 

 

   

 

 

 

Non-controlling interests

        19,985       3,803  
     

 

 

   

 

 

 

Total equity

        2,017,409       2,172,161  
     

 

 

   

 

 

 

Total liabilities and equity

        4,106,463       4,274,839  
     

 

 

   

 

 

 

See accompanying notes to condensed interim consolidated financial statements.

 

4


(4) Condensed Interim Consolidated Statements of Changes in Equity (Unaudited)

Six months period ended September 30, 2017 (From April 1 to September 30, 2017)

 

          JPY (millions)  
          Equity attributable to owners of the Company              
                                  Other components of equity                          
    Note     Share
capital
    Share
premium
    Treasury
shares
    Retained
earnings
    Exchange
differences
on translation
of foreign
operations
    Changes in fair
value of
financial assets
measured at
fair value
through other
comprehensive
income
    Net changes
on
revaluation of
available-for-
sale financial
assets
    Cash flow
hedges
    Hedging cost     Re-
measurement
gain or loss
on defined
benefit plans
    Total     Other
comprehensive
income
related to
assets held
for sale
    Total     Non-
controlling
interests
    Total
equity
 

As of April 1, 2017

      65,203       74,973       (48,734     1,511,817       221,550       —         67,980       1,472       —         —         291,002       —         1,894,261       54,704       1,948,965  
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net profit for the period

            172,816                   —           172,816       (146     172,670  

Other comprehensive income

              86,093         8,132       1,523       691       688       97,127         97,127       345       97,472  
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive income for the period

      —         —         —         172,816       86,093       —         8,132       1,523       691       688       97,127       —         269,943       199       270,142  
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Transactions with owners:

                               

Issuance of new shares

      754       754                       —           1,508         1,508  

Acquisition of treasury shares

          (18,742                   —           (18,742       (18,742

Disposal of treasury shares

        0       0                     —           0         0  

Dividends

    9             (70,956                 —           (70,956     (2,189     (73,145

Changes in ownership

                          —           —         (32,750     (32,750

Transfers from other components of equity

            688                 (688     (688       —           —    

Share-based compensation

        8,572                       —           8,572         8,572  

Exercise of share-based awards

        (14,758     15,905                     —           1,147         1,147  

Transfers to non-financial assets

                          —           —           —    
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total transactions with owners

      754       (5,432     (2,837     (70,268     —         —         —         —         —         (688     (688     —         (78,471     (34,939     (113,410
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

As of September 30, 2017

      65,957       69,541       (51,571     1,614,365       307,643       —         76,112       2,995       691       —         387,441       —         2,085,733       19,964       2,105,697  
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

See accompanying notes to condensed interim consolidated financial statements.

 

5


Six months period ended September 30, 2018 (From April 1 to September 30, 2018)

 

          JPY (millions)  
          Equity attributable to owners of the Company              
                                  Other components of equity                          
    Note     Share
capital
    Share
premium
    Treasury
shares
    Retained
earnings
    Exchange
differences
on translation
of foreign
operations
    Changes in fair
value of
financial assets
measured at
fair value
through other
comprehensive
income
    Net changes
on
revaluation of
available-for-
sale financial
assets
    Cash flow
hedges
    Hedging cost     Re-
measurement
gain or loss
on defined

benefit plans
    Total     Other
comprehensive
income
related to
assets held
for sale
    Total     Non-
controlling
interests
    Total
equity
 

As of April 1, 2018

      77,914       90,740       (74,373     1,557,307       272,597       —         73,037       3,391       1,606       —         350,631       (4,795     1,997,424       19,985       2,017,409  

Cumulative effects of changes in accounting policies

    3             15,401         84,672       (73,037     (1,378         10,257         25,658       (10     25,648  
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Restated balance

      77,914       90,740       (74,373     1,572,708       272,597       84,672       —         2,013       1,606       —         360,888       (4,795     2,023,082       19,975       2,043,057  
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net profit for the period

            126,668                   —           126,668       (179     126,489  

Other comprehensive income (loss)

              61,937       12,954         1,704       (152     (164     76,279       4,795       81,074       (168     80,906  
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive income (loss) for the period

      —         —         —         126,668       61,937       12,954       —         1,704       (152     (164     76,279       4,795       207,742       (347     207,395  
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Transactions with owners:

                               

Issuance of new shares

      28       28                       —           56         56  

Acquisition of treasury shares

          (1,158                   —           (1,158       (1,158

Disposal of treasury shares

        (0     3                     —           3         3  

Dividends

    9             (71,188                 —           (71,188     (168     (71,356

Changes in ownership

            (2,126     230                 230         (1,896     (15,657     (17,553

Transfers from other components of equity

            22,032         (22,196           164       (22,032       —           —    

Share-based compensation

        9,384                       —           9,384         9,384  

Exercise of share-based awards

        (18,375     18,361                     —           (14       (14

Transfers to non-financial assets

                    2,347           2,347         2,347         2,347  
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total transactions with owners

      28       (8,963     17,206       (51,282     230       (22,196     —         2,347       —         164       (19,455     —         (62,466     (15,825     (78,291
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

As of September 30, 2018

      77,942       81,777       (57,167     1,648,094       334,764       75,430       —         6,064       1,454       —         417,712       —         2,168,358       3,803       2,172,161  
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

See accompanying notes to condensed interim consolidated financial statements.

 

6


(5) Condensed Interim Consolidated Statements of Cash Flows (Unaudited)

 

     JPY (millions)  
     Six months period ended September 30,  
     2017     2018  

Cash flows from operating activities:

    

Net profit for the period

     172,670       126,489  

Depreciation and amortization

     93,420       77,976  

(Reversal of) Impairment losses

     (9,229     690  

Share-based compensation

     8,572       9,384  

Loss (gain) on sales and disposal of property, plant and equipment

     50       (5,623

Gain on divestment of business

     (3,086     (2,266

Gain on sales of subsidiaries

     (106,619     (14,365

Change in fair value of contingent consideration

     6,646       (1,230

Finance income and expenses, net

     1,867       15,207  

Share of gain of associates accounted for using the equity method

     (506     (4,031

Income tax expenses

     60,318       34,291  

Changes in assets and liabilities:

    

Increase in trade and other receivables

     (35,033     (44,721

Increase in inventories

     (3,019     (21,485

Decrease in trade and other payables

     (7,559     (230

Increase (decrease) in provisions

     (4,825     1,594  

Other, net

     (2,778     (35,001
  

 

 

   

 

 

 

Cash generated from operations

     170,889       136,679  
  

 

 

   

 

 

 

Income taxes paid

     (28,168     (20,407

Tax refunds and interest on tax refunds received

     24,309       1,562  
  

 

 

   

 

 

 

Net cash from operating activities

     167,030       117,834  
  

 

 

   

 

 

 

Cash flows from investing activities:

    

Interest received

     1,083       1,037  

Dividends received

     6,094       1,575  

Acquisition of property, plant and equipment

     (36,303     (37,314

Proceeds from sales of property, plant and equipment

     76       6,046  

Acquisition of intangible assets

     (46,910     (21,105

Acquisition of investments

     (5,787     (10,340

Proceeds from sales and redemption of investments

     14,346       38,196  

Acquisition of businesses, net of cash and cash equivalents acquired

     (17,787     (66,749

Proceeds from sales of business, net of cash and cash equivalents divested

     85,036       27,199  

Proceeds from withdrawal of restricted deposits

     —         71,774  

Other, net

     23,344       (12,461
  

 

 

   

 

 

 

Net cash from (used in) investing activities

     23,192       (2,142
  

 

 

   

 

 

 

Cash flows from financing activities:

    

Net decrease in short-term loans

     (403,948     (362

Proceeds from long-term loans

     337,154       —    

Proceeds from issuance of bonds

     56,299       —    

Purchase of treasury shares

     (18,729     (1,158

Interest paid

     (3,587     (4,467

Dividends paid

     (70,966     (71,448

Acquisition of non-controlling interests

     —         (2,392

Repayment of obligations under finance lease

     (1,297     (1,284

Facility fees paid for loan agreements

     —         (15,404

Other, net

     (3,056     (659
  

 

 

   

 

 

 

Net cash used in financing activities

     (108,130     (97,174
  

 

 

   

 

 

 

Net increase in cash and cash equivalents

     82,092       18,518  

Cash and cash equivalents at the beginning of the year (Consolidated statements of financial position)

     319,455       294,522  

Cash and cash equivalents reclassified back from assets held for sale

     21,797       451  
  

 

 

   

 

 

 

Cash and cash equivalents at the beginning of the year

     341,252       294,973  

Effects of exchange rate changes on cash and cash equivalents

     7,551       3,589  
  

 

 

   

 

 

 

Cash and cash equivalents at the end of the period

     430,895       317,080  
  

 

 

   

 

 

 

See accompanying notes to condensed interim consolidated financial statements.

 

7


Notes to Condensed Interim Consolidated Financial Statements (Unaudited)

 

1

Reporting Entity

Takeda Pharmaceutical Company Limited (the “Company”) is a public company incorporated in Japan.

The Company and its subsidiaries (collectively, “Takeda”) is a major global pharmaceutical group and is engaged in the research, development, manufacturing and marketing of pharmaceutical products, over-the-counter (“OTC”) medicines and quasi-drug consumer products, and other healthcare products. Takeda’s principal pharmaceutical products include medicines in the following therapeutic areas: gastroenterology, oncology and neuroscience.

 

2

Basis of Preparation

 

  (1)

Compliance

Takeda has prepared the condensed interim consolidated financial statements in accordance with IAS34 “Interim Financial Reporting” as issued by the International Accounting Standards Board (“IASB”).

The condensed interim consolidated financial statements do not contain all the information required in consolidated financial statements as of the end of a fiscal year. Therefore, the condensed interim consolidated financial statements should be used with the consolidated financial statements as of and for the fiscal year ended March 31, 2018.

 

  (2)

Functional Currency and Presentation Currency

The condensed interim consolidated financial statements are presented in Japanese yen (“JPY”), which is the functional currency of the Company. All financial information presented in JPY has been rounded to the nearest million, except when otherwise indicated.

 

  (3)

Approval of Financial Statements

Takeda’s condensed interim consolidated financial statements as of and for the period ended September 30, 2018 were approved on November 8, 2018 by Representative Director, President & Chief Executive Officer (“CEO”) Christophe Weber and Corporate Officer & Chief Financial Officer Costa Saroukos.

 

  (4)

Use of Judgments, Estimates and Assumptions

The preparation of the condensed interim consolidated financial statements requires management to make certain judgments, estimates and assumptions that affect the application of accounting policies and the reported amounts of assets, liabilities, revenue and expenses. Actual results may differ from these estimates.

These estimates and underlying assumptions are reviewed on a continuous basis by the management. Changes in these accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.

The condensed interim consolidated financial statements are prepared based on the same judgments and estimations as well as the accounting estimates and assumptions applied and described in Takeda’s consolidated financial statements for the fiscal year ended March 31, 2018, except for new significant judgments and uncertainty of the estimations related to the application of IFRS 9 ‘Financial instruments’ (“IFRS 9”) and IFRS 15 ‘Revenue from Contracts with Customers’ (“IFRS 15”) , which are described in Note 3 “Significant Accounting Policies”.

 

8


3

Significant Accounting Policies

Significant accounting policies adopted for the condensed interim consolidated financial statements are the same as those adopted for the consolidated financial statements of the fiscal year ended March 31, 2018 except for the policies required by IFRS 9 and IFRS 15.

Takeda calculated income tax expenses for the six months period ended September 30, 2018, based on the estimated average annual effective tax rate.

IFRS 9 ‘Financial instruments’

IFRS 9 was adopted by Takeda as of April 1, 2018. IFRS 9 replaces the majority of the requirements of IAS 39 ‘Financial Instruments: Recognition and Measurement’ and covers the classification, recognition, measurement, and de-recognition of financial assets and financial liabilities, introduces a new impairment model for financial assets based on expected losses rather than incurred losses and provides a new hedge accounting model.

The principal impact of the adoption of IFRS 9 for Takeda was the re-measurement of certain available-for-sale financial instruments to fair value as of April 1, 2018. In addition, as a result of adoption, Takeda elected to designate equity instruments as financial assets measured at fair value through other comprehensive income (FVTOCI). This designation has been made on the basis of the facts and circumstances that existed at the date of initial application. Changes in the fair value of financial assets at FVTOCI are recognized in other comprehensive income, and the cumulative amount of other comprehensive income is transferred to retained earnings when the instruments are derecognized due to liquidation or sale.

The classification of financial assets under IFRS 9 is generally based on the business model in which a financial asset is managed and its contractual cash flow characteristics. The determination of the business model within which a financial asset is held has been made on the basis of the facts and circumstances that existed at the date of initial application.

The impairment of financial assets measured at amortized cost is assessed using an expected credit loss (ECL) model where previously the incurred loss model was used. Given the nature of Takeda’s financial assets, there was no significant impact on the provisions for doubtful accounts or impairments upon adoption of the new standard.

The adoption of IFRS 9 has not had material impact on Takeda’s financial liabilities and derivatives.

The new hedge accounting model introduced by the standard requires hedge accounting relationships to be based upon Takeda’s own risk management objectives and strategy, and to apply a more qualitative and forward-looking approach to assessing hedge effectiveness. The model is to be discontinued only when the relationships no longer qualify for hedge accounting. All hedging relationships designated under IAS39 at March 31, 2018 met the criteria for hedge accounting under IFRS 9 at April 1, 2018 and are therefore regarded as continuing hedging relationships.

Takeda applied IFRS 9 retrospectively with respect to classification and measurement (including impairment) without restating previous years. These cumulative effects of initially applying IFRS 9 were recognized in equity as of the date of initial application of IFRS 9 (April 1, 2018). As a result of the adoption on the date of initial application, the opening balance of retained earnings and other components of equity increased by 14,073 million JPY and 10,257 million JPY, respectively, while other financial assets (non-current), other financial assets (current), deferred tax liabilities increased by 32,809 million JPY, 856 million JPY and 9,345 million JPY respectively, with non-controlling interests decreasing by 10 million JPY.

In addition, under IAS 39, the currency basis spread was included in “Cash Flow Hedges” under other components of equity. Under IFRS 9, this basis spread is separately accounted for and presented as “Hedging Cost” under other components of equity. Takeda retrospectively applied the accounting treatment

 

9


of hedging cost and adjusted the comparative information. As of September 30, 2017 and March 31, 2018, the amounts retrospectively recorded as “Hedging Cost” and deducted from “Cash Flow Hedges” were 691 million JPY and 1,606 million JPY, respectively.

Classifications and carrying amounts of financial assets under IAS 39 and IFRS 9 as of the date of adoption were changed as presented in the table below. For investments in equity instruments, Takeda made an irrevocable election at the time of initial recognition to account for the equity instruments at FVTOCI. There were no changes to the classifications and carrying amounts of the financial liabilities.

 

              JPY (millions)  
     IAS 39   Carrying
amount
    IFRS 9   Carrying
amount
 

Cash and cash equivalents

 

Loans and receivables

    294,522    

Financial assets measured at amortized cost

    294,522  

Derivatives

 

Financial assets measured at fair value through profit or loss

    762    

Financial assets measured at fair value through profit or loss

    762  

Derivative transactions to which hedge accounting is applied

 

Derivative transactions to which hedge accounting is applied

    2,527    

Derivative transactions to which hedge accounting is applied

    2,527  

Trade and other receivables, other financial assets

 

Loans and receivables

    516,853    

Financial assets measured at amortized cost

    516,853  

Equity instruments

 

Available-for-sale financial assets

 

 

169,814

 

 

Financial assets measured at fair value through other comprehensive income

    203,276  

Convertible notes

 

Loans and receivables

    5,303    

Financial assets measured at fair value through profit or loss

 

 

7,576

 

 

Financial assets measured at fair value through profit or loss

    2,070  

Total

        991,851           1,025,516  

The following changes were made to the carrying amount of the financial assets as of the date of adoption.

 

                      JPY (millions)  
IAS 39   Carrying
amount
    Change in
classification
    Re-
measurement
    IFRS 9   Carrying
amount
 

Loans and receivables

    816,678       (5,303     —      

Financial assets measured at amortized cost

    811,375  

Financial assets measured at fair value through profit or loss

    2,832       5,303       203    

Financial assets measured at fair value through profit or loss

    8,338  

Derivative transactions to which hedge accounting is applied

    2,527       —         —      

Derivative transactions to which hedge accounting is applied

    2,527  

Available-for-sale financial
assets

 

 

169,814

 

 

 

—  

 

 

 

33,462

 

 

Financial assets measured at fair value through other comprehensive income

    203,276  

Total

    991,851       —         33,665           1,025,516  

Measurement of Financial Instruments

Debt Instruments:

 

   

Amortized cost: Assets such as trade and other receivables that are held within a business model whose objective is to hold financial assets in order to collect contractual cash flows and whose contractual terms give rise on specified dates to cash flows that are solely payments of principal and interest on the principal amount outstanding are measured at amortized cost. Trade receivables are

 

10


 

initially recognized at their invoiced amounts, including any related sales taxes less adjustments for estimated revenue deductions such as rebates, and cash discounts. Provisions for doubtful trade receivables are established using an ECL model. The provisions are based on a forward-looking ECL, which includes possible default events on the trade receivables over the entire holding period of the trade receivables. Takeda has elected to measure provisions for trade receivables and lease receivables at an amount equal to lifetime ECL. Takeda uses provision matrix to calculate ECL. These provisions represent the difference between the carrying amount of the trade receivables and the lease receivables in the consolidated statements of financial position and the estimated net collectible amount.

 

   

FVTOCI: Assets that are held within a business model whose objective is achieved by both collecting contractual cash flows and selling financial assets and whose contractual terms give rise on specified dates to cash flows that are solely payments of principal and interest on the principal amount outstanding are measured at FVTOCI. When the financial asset is derecognized, the cumulative gain or loss previously recognized in other comprehensive income is reclassified from equity to net profit or loss.

 

   

Fair value through profit or loss (FVTPL): Assets that do not meet the criteria for amortized cost or FVTOCI are measured at FVTPL. A gain or loss on debt instruments that is measured at FVTPL is recognized in net profit or loss.

Equity Instruments:

 

   

Equity instruments are measured at FVTPL. However, on initial recognition, Takeda made an irrevocable FVTOCI election (on an instrument-by-instrument basis) to present the subsequent changes in the fair value of equity instruments in other comprehensive income. As at the reporting date, Takeda designated all its equity instruments as financial assets at FVTOCI.

Derivatives and Hedge Accounting:

 

   

Derivatives are measured at FVTPL unless the derivative contracts are designated as hedging instruments. Gains or losses on derivatives are recognized in net profit or loss. When the derivative contracts are designated as hedging instruments in cash flow hedging relationships, the effective portion of changes in fair value of derivatives is accumulated in other comprehensive income. The currency basis spread is accounted for and presented as “Hedging Cost” under other components of equity separately from “Cash Flow Hedges”.

IFRS 15 ‘Revenue from Contracts with Customers’

Takeda adopted IFRS 15 on April 1, 2018. The new standard provides a single, principles-based approach to the recognition of revenue from all contracts with customers. The standard focuses on the identification of performance obligations in a contract and requires revenue to be recognized when or as those performance obligations are satisfied. The standard also has more detailed disclosure requirements.

The impacts of adoption of the new standard are summarized below:

 

   

Takeda derives revenue from sales of pharmaceutical products as well as other services where control transfers to customers and performance obligations are satisfied either at the point in time of shipment, receipt of the products by the customer or when the services are performed.

 

   

Takeda also recognizes royalty revenue relating to the out-licensing of intellectual property (IP), which is recognized when the underlying sales have occurred, and revenue from other services such as research and development of compounds out-licensed, which is recognized over the service period.

 

11


   

Takeda’s revenue also includes revenue from out-licensing and granting of IP rights and Takeda usually receives upfront payments or milestone payments for these arrangements. Revenue from the upfront payments is generally recognized when Takeda provides a right to use the IP. Revenue from the milestone payments is generally recognized at the point in time when it is highly probable that the respective milestone event criteria are met, and a significant reversal in the amount of revenue recognized will not occur.

These impacts of adoption of the new standard were immaterial. Takeda elected the modified retrospective method upon adoption of IFRS 15. This method requires the recognition of the cumulative effect of initially applying IFRS 15 in equity at the date of initial application of IFRS 15 (April 1, 2018) and Takeda did not restate the result of prior years. As a result of the adoption of IFRS 15, due to the difference in allocation of revenue to performance obligations, other non-current liabilities, other current liabilities, deferred tax assets decreased by 1,247 million JPY, 495 million JPY and 414 million JPY respectively, and opening retained earnings increased by 1,328 million JPY.

For the six months period ended September 30, 2018, the impact from adoption of IFRS 15 on the condensed interim consolidated financial statements was immaterial compared to the financial statements under IAS 18.

As the results of the adoption of IFRS 15, Takeda updated and revised the related accounting policy as follows:

Revenue on sales of Takeda products and services is recognized when a contractual promise to a customer (performance obligation) has been fulfilled by transferring control over the promised goods and services to the customer, generally at the point in time of shipment to or receipt of the products by the customer, or when the services are performed. The amount of revenue to be recognized is based on the consideration Takeda expects to receive in exchange for its goods and services. If a contract contains more than one performance obligation, the consideration is allocated based on the standalone selling price of each performance obligation.

The consideration Takeda receives in exchange for its goods or services may be fixed or variable. Variable consideration is only recognized when it is highly probable that a significant reversal will not occur. The most common elements of variable consideration are listed below:

 

   

Rebates and discounts granted to government agencies, wholesalers, retail pharmacies, managed healthcare organizations and other customers are estimated and recorded as a deduction from revenue at the time the related revenues are recorded. They are calculated on the basis of historical experience and the specific terms in the individual agreements.

 

   

Cash discounts are offered to customers and are provisioned and recorded as revenue deductions at the time the related sales are recorded.

 

   

Sales return provisions are recognized and recorded as revenue deductions when there is historical experience of Takeda agreeing to customer returns and Takeda can reasonably estimate expected future returns. In doing so, the estimated rate of return is applied, determined based on historical experience of customer returns and considering any other relevant factors. The rate is multiplied by the amounts invoiced in order to estimate expected future returns.

Takeda also generates revenue in the form of royalty payments, upfront payments, and milestone payments from the out-licensing of intellectual property (IP). Royalty revenue earned through a license is recognized when the underlying sales have occurred. Revenue from upfront payment is generally recognized when Takeda provides a right to use IP. Revenue from milestone payments is recognized at the point in time when it is highly probable that the respective milestone event criteria is met, and a significant reversal in the amount of revenue recognized will not occur.

Revenue from other services such as research and development of compounds that are out-licensed is recognized over the service period.

 

12


4

Revenue

The disaggregation of revenue by goods and services is as follows:

 

    JPY (millions)
     Six months period ended September 30,
     2017    2018

Sales of pharmaceutical products

  838,266          855,722      

Royalty and service income

  43,150          24,889      

Total

  881,416          880,611      
    JPY (millions)
     Three months period ended September 30,
     2017    2018

Sales of pharmaceutical products

  420,348          418,891      

Royalty and service income

  12,829          11,886      

Total

  433,177          430,777      

The disaggregation of revenue by geographic location is as follows. This disaggregation provides revenue attributable to countries or regions based on the customer location.

 

                                  JPY (millions)  
Six months period ended
September 30,
  Japan     U.S.    

Europe

and
Canada

    Russia/
CIS
    Latin
America
    Asia     Other     Total  

2017

    294,987       301,784       148,938       35,111       36,063       49,189       15,344       881,416  

2018

    274,243       321,079       158,603       27,484       34,685       51,905       12,612       880,611  

Other includes the Middle East, Oceania and Africa.

 

                                  JPY (millions)  
Three months period ended
September 30,
  Japan     U.S.    

Europe

and
Canada

    Russia/
CIS
    Latin
America
    Asia     Other     Total  

2017

    134,691       153,196         75,366       18,072       19,111       24,038         8,703       433,177  

2018

    129,983       159,979       79,481       13,359       16,180       25,024       6,771       430,777  

Other includes the Middle East, Oceania and Africa.

 

5

Other Operating Income

Other operating income for the six months period ended September 30, 2017 included the gain on the sale of shares of 106,337 million JPY which was due to the sale of shareholding in Wako Pure Chemical, Ltd. to FUJIFILM corporation.

Other operating income for the six months period ended September 30, 2018 included the gain on the sale of shares of 18,381 million JPY which was due to the sale of shareholding in Guangdong Techpool Bio-Pharma Co., Ltd. to Shanghai Pharmaceutical Holding Co. Ltd. and SFund International Investment Fund Management Limited.

 

6

Other Operating Expenses

Other operating expenses for the six months period ended September 30, 2017 included expenses from reorganizations activities, which was mainly due to reductions in the workforce and consolidation of sites

 

13


and functions to improve the efficiency of its operations (“Restructuring expenses”). The amount of the Restructuring expenses was 13,723 million JPY which included R&D transformation costs, and the post-merger integration costs related to the acquisition of ARIAD Pharmaceuticals, Inc. as well as the expenses of 6,646 million JPY associated with changes in contingent considerations (*).

Other operating expenses for the six months period ended September 30, 2018 included the restructuring expenses of 14,097 JPY related to global operating expense reduction initiative and R&D transformation initiative as well as the proposed Shire acquisition. In addition, other operating expenses for the same period also included the reversal of pre-launch inventory write-offs of (7,710) million JPY due to regulatory approval and the loss of 4,016 million JPY which was due to the sale of shareholding in Multilab Indústria e Comércio de Produtos Farmacê uticos Ltda. to Novamed Fabricação de Produtos Farmacêuticos Ltda.

 

  (*)

The contingent considerations are recognized at fair value as part of the purchase price when specified future events arising from business combinations occur.

 

7

Earnings Per Share

The basis for calculating basic and diluted earnings per share (attributable to owners) is as follows:

 

     Six months period ended September 30,
     2017    2018

Net profit for the period attributable to owners of the Company

        

Net profit attributable to owners of the Company (million JPY)

  172,816          126,668      

Net profit used for calculation of earnings per share (million JPY)

  172,816          126,668      
     

Weighted average number of ordinary shares outstanding during the period (thousands of shares) [basic]

  780,468          783,062      

Dilutive effect (thousands of shares)

  5,122          4,030      

Weighted average number of ordinary shares outstanding during the period (thousands of shares) [diluted]

  785,590          787,092      
     

Earnings per share

        

Basic (JPY)

  221.43          161.76      

Diluted (JPY)

  219.98          160.93      

 

     Three months period ended September 30,
     2017    2018

Net profit for the period attributable to owners of the Company

        

Net profit attributable to owners of the Company (million JPY)

  28,027          48,426      

Net profit used for calculation of earnings per share (million JPY)

  28,027          48,426      
     

Weighted average number of ordinary shares outstanding during the period (thousands of shares) [basic]

  780,971          784,436      

Dilutive effect (thousands of shares)

  4,853          3,248      

Weighted average number of ordinary shares outstanding during the period (thousands of shares) [diluted]

  785,824          787,684      
     

Earnings per share

        

Basic (JPY)

  35.89          61.73      

Diluted (JPY)

  35.67          61.48      

 

14


8

Collaborations and Licensing Arrangements

Takeda is a party to certain collaborative and licensing arrangements. These agreements generally provide for commercialization rights to a product or products being developed by the counterparty, and, in exchange, often resulted in upfront payments upon execution of the agreement and resulting in an obligation that requires Takeda to make future development, regulatory approval, or commercial milestone payments as well as royalty payments. In some of these arrangements, Takeda and the licensee are both actively involved in the development and commercialization of the licensed product, and have exposure to risks and rewards that are dependent on its commercial success.

The significant agreements in collaboration and licensing during the six months period ended September 30, 2018 is described below.

Wave Life Sciences Ltd. (“Wave”)

In February 2018, Takeda entered into an agreement with Wave to discover, develop and commercialize nucleic acid therapies for disorders of the central nervous system (“CNS”) and the agreement became effective in April 2018 after the receipt of clearance under the Hart-Scott- Rodino Antitrust Improvement Act (HSR Act). Under the agreement, Wave will provide Takeda the option to co-develop and co-commercialize programs in areas of Huntington’s disease (HD), amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD) and spinocerebellar ataxia type 3 (SCA3). In addition, Takeda will have the right to license multiple preclinical programs targeting CNS disorders, including Alzheimer’s disease and Parkinson’s disease. The agreement required upfront payments, investment in Wave and future contingent payments such as development and commercial milestone payments. Wave will continue to independently advance its activities in neuromuscular diseases including its lead clinical program for the treatment of Duchene muscular dystrophy (DMD).

 

9

Dividends

 

Dividends Declared and Paid  

Total

dividends

(million

JPY)

   

Dividends

per Share

(JPY)

    Basis Date   Effective Date

April 1, 2017 to September 30, 2017

    71,133       90.00     March 31, 2017   June 29, 2017

April 1, 2018 to September 30, 2018

    71,507       90.00     March 31, 2018   June 29, 2018

Dividends declared for which the effective date falls after September 30, 2018 are as follows:

 

Dividends Declared  

Total

dividends

(million

JPY)

   

Dividends

per Share

(JPY)

    Basis Date   Effective Date

Board of Directors on October 31, 2018

    71,509       90.00     September 30, 2018     December 3, 2018  

 

10

Financial Instruments

 

  (1)

Fair Value Measurements

 

  (i)

Financial assets and liabilities measured at fair value through profit or loss

The fair value of derivatives to which hedge accounting was not applied is measured at quoted prices or quotes obtained from financial institutions, whose significant inputs to the valuation model used are based on observable market data.

The fair value of convertible notes is measured using techniques such as the option pricing model.

 

15


Contingent consideration, resulting from business combinations, is valued at fair value at the acquisition date as part of the business combination. When the contingent consideration meets the definition of a financial liability, it is subsequently re-measured to fair value at each reporting date. The determination of the fair value is based on discounted cash flows. The key assumptions taken into consideration are the probability of meeting each performance target and the discount factor. The fair value measurement of contingent considerations arising from business combinations is stated in Note11, “Business Combinations.”

 

  (ii)

Financial assets measured at amortized cost

The carrying amount of financial assets measured at amortized cost approximate their fair values as these assets are settled within a short period.

 

  (iii)

Equity instruments

The fair value of listed equity instruments is measured at quoted prices or quotes obtained from financial institutions.

The fair value of unlisted equity instruments is measured using techniques such as the net asset book value method and the multiples approach. Under the multiples approach, listed companies similar to the target companies are selected, and the fair value is calculated using the stock index for those similar companies.

 

  (iv)

Derivative transactions to which hedge accounting is applied

The fair value of derivative transactions to which hedge accounting is applied is measured in the same manner as “(i) Financial assets and liabilities measured at fair value through profit or loss”.

 

  (v)

Financial liabilities measured at amortized cost

The fair value of bonds is measured at quotes obtained from financial institutions, and the fair value of loans and finance leases are measured at the present value of future cash flows discounted using the applicable effective interest rate, with consideration of the credit risk by each liability group classified in a specified period.

Other current items are settled in a short period, and the coupon rates of other non-current items reflect market interest rates. Therefore, the carrying amounts of these liabilities approximate their fair values.

 

  (2)

Fair Value Hierarchy

Level 1: Fair value measured at quoted prices in active markets

Level 2: Fair value that is calculated using an observable price other than that categorized in Level 1 directly or indirectly

Level 3: Fair value that is calculated based on valuation techniques which include input that is not based on observable market data

 

16


  (3)

Fair Value of Financial Instruments Carried at Cost

The carrying amount and fair value of financial instruments that are not recorded at fair value in the condensed interim consolidated statements of financial position are as follows:

 

    JPY (millions)  
     As of September 30, 2018  
  Carrying amount     Fair value  

Bonds

    176,402       174,936  

Long-term loans

    823,199       824,312  

Finance leases

    55,264       54,836  

The amounts to be paid within a year are included. The fair value of bonds, long-term loans and finance leases are classified as Level 2 in the fair value hierarchy.

This table excludes financial instruments that have carrying amounts that approximates fair value.

 

  (4)

Fair Value Measurement Recognized in the Condensed Interim Consolidated Statements of Financial Position

JPY (millions)

 

As of September 30, 2018   Level 1     Level 2     Level 3     Total  

Assets:

               

Financial assets measured at fair value through profit or loss:

               

Derivatives

    —         6,161       —         6,161  

Convertible notes

    —         —         9,128       9,128  

Derivative transactions to which hedge accounting is applied

    —         11,698       —         11,698  

Financial assets measured at fair value through other comprehensive income:

               

Equity instruments

    147,403       31       44,731       192,165  

Total

    147,403       17,890       53,859       219,152  

Liabilities:

               

Financial liabilities measured at fair value through profit or loss:

               

Derivatives

    —         5,258       —         5,258  

Contingent considerations arising from business combinations

    —         —         29,762       29,762  

Derivative transactions to which hedge accounting is applied

    —         1,906       —         1,906  

Total

    —         7,164       29,762       36,926  

Takeda recognizes transfers between levels of the fair value hierarchy, at the end of the reporting period during which the change has occurred. There were no transfers among Level 1, Level 2 and Level 3 for the six months period ended September 30, 2018.

Disclosures related to contingent considerations arising from business combinations are stated in Note 11, “Business Combinations”.

 

17


  (5)

Reconciliation of Level 3 Financial Assets

 

    JPY (millions)  
    

Six months period ended

September 30, 2018

 

Opening balance

    47,789  

Gain or loss:

   

Net profit

    148  

Other comprehensive income

    144  

Purchases

    5,791  

Sales

    (10

Other

    (3

Closing balance

    53,859  

Gain or loss recorded in profit or loss relates to the financial assets measured at fair value through profit or loss. These gains or losses are recognized as “financial income” or “financial expenses” in the condensed interim consolidated statements of income.

Gain or loss recorded in other comprehensive income relates to the financial assets measured at fair value through other comprehensive income. These gains or losses are recognized as “Changes in fair value of financial assets measured at fair value through other comprehensive income” and “Exchange differences on translation of foreign operations” in the condensed interim consolidated statements of income and other comprehensive income.

The fair values of equity instruments are measured by Takeda’s accounting and finance departments using available information as of each closing date based on Takeda’s accounting policy. The results of the fair value measurement and the calculation process are reported to management as necessary.

The principle input that is not observable and used for the calculation of the fair value of equity instruments classified as Level 3 is the EBITDA rate used for the multiples approach, ranging from 7.4 times to 17.5 times. The fair value of the equity instruments increases (decreases) as the EBITDA rate increases (decreases).

 

11

Business Combinations

 

  (1)

Acquisitions

TiGenix NV (“TiGenix”)

On April 30, 2018, Takeda made an all cash voluntary public takeover bid for the entire issued ordinary shares (“Ordinary Shares”), warrants (“Warrants”) and American Depositary Shares (“ADSs” and together with the Ordinary Shares and the Warrants, the “Securities”) of TiGenix not already owned by Takeda. On June 8, 2018, the Company acquired the Securities tendered in the first acceptance period for 470.2 million EUR. In response to the takeover bid with the Securities already owned by Takeda, Takeda acquired 90.8% of the voting rights.

TiGenix is a biopharmaceutical company developing novel stem cell therapies for serious medical conditions. This acquisition will expand Takeda’s late stage gastroenterology (GI) pipeline with the U.S. rights to Cx601 (darvadstrocel), a suspension of allogeneic expanded adipose-derived stem cells (eASC) under investigation for the treatment of complex perianal fistulas in patients with non-active/mildly active luminal Crohn’s disease (CD). Following the 2nd Takeover bid and a squeeze-out ended in July 2018, TiGenix became a wholly owned subsidiary of Takeda.

 

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The following represents provisional fair value of assets acquired, liabilities assumed:

 

     JPY (millions)  
     Amount  

Intangible assets

    63,421  

Other assets

    5,541  

Deferred tax liabilities

    (10,128

Other liabilities

    (5,678

Basis adjustments

    (3,381

Goodwill

    20,228  

Total

    70,003  

The purchase consideration was comprised of the following:

 

     JPY (millions)  
     Amount  

Cash

    67,319  

The ordinary shares of TiGenix already owned by Takeda immediately prior to the acquisition date

    2,684  

Total

    70,003  

Goodwill comprises excess earning power expected from the future business development. Goodwill is not deductible for tax purposes.

The fair value primarily consisting of intangible assets, deferred tax liabilities and goodwill assumed as of the acquisition date have been recorded provisionally based on the information available as of September 30, 2018. These amounts are subject to change as the Company is in the process of reviewing further details of the basis for the fair value measurement. For the three months period ended September 30, 2018, goodwill at the acquisition date increased by 253 million JPY as a result of the adjustment to the provisional fair value, while other assets decreased by 253 million JPY.

Takeda entered into a forward exchange contract to hedge foreign currency risks and applied the hedge accounting to the contract. Basis adjustment represents a fair value of the hedging instrument of 3,381 million JPY that was added to the amount of goodwill at the acquisition date.

No gains or losses were recognized as a result of remeasurement of fair value of the ordinary shares of TiGenix already owned by Takeda immediately prior to the acquisition date.

Acquisition-related costs of 767 million JPY which included agent fee and due diligence costs arising from the acquisition were recorded in “Selling, general and administrative expenses”.

The revenue and the net profit of TiGenix for the post-acquisition period, which were recognized in the condensed interim consolidated statements of income for the six months period ended September 30, 2018, were immaterial.

The impact on Takeda’s revenue and net profit for the six months period ended September 30, 2018 assuming the acquisition date of TiGenix had been as of the beginning of the reporting period was immaterial.

 

  (2)

Contingent Considerations

The consideration for certain acquisitions includes amounts contingent upon future events such as the achievement of development milestones and sales targets. At each reporting date, the fair value of contingent considerations assumed in business combinations is re-measured based on risk-adjusted future cash flows discounted using appropriate discount rate. The contingent considerations discussed

 

19


below are the discounted royalty payable for a certain period based on future financial performance, primarily consisting of the COLCRYS business which was acquired in the acquisition of URL Pharma. Inc. in June 2012. There is no cap on the royalty payable for the COLCRYS business and the estimated future royalty payments are calculated based on forecasted financial performance.

The fair value of contingent considerations is classified as Level 3 in the fair value hierarchy. The definition of the fair value hierarchy is stated in Note 10, “Financial Instruments”.

 

  1)

Changes in the Fair Value of Contingent Considerations

 

    JPY (millions)  
     Six months period ended
September 30, 2018
 

As of the beginning of the period

    30,569  

Additions arising from business combinations

    —    

Changes in the fair value during the period (unrealized):

   

URL Pharma. Inc.

    341  

Other

    (92

Settled during the period:

   

URL Pharma. Inc.

    (1,129

Other

    —    

Reclassification to other payables

    (1,774

Foreign currency translation differences

    1,934  

Other

    (87

As of the end of the period

    29,762  

 

  2)

Sensitivity Analysis

The following sensitivity analysis represents effect on the fair value of contingent considerations from changes in major assumptions:

 

        JPY (millions)  
     As of September 30,
2018
 

Revenue derived from the COLCRYS business

 

     Increase by 5%

    Decrease by 5%

   

716

(716

 

Discount rate

 

    Increase by 0.5%

   Decrease by 0.5%

   

(178

181


 

 

12

Disposal Groups Held for Sale

The disposal groups held for sale as of March 31, 2018, consisted mainly of a group of assets, liabilities, and other comprehensive income related to Takeda’s consolidated subsidiary, Multilab Indústria e Comércio de Produtos Farmacêuticos Ltda. and reclassified as held for sale. The shares of the subsidiary were sold in July 2018. Takeda entered into an agreement in May 2018 to sell its entire shareholding of 51.34% in consolidated subsidiary Guangdong Techpool Bio-Pharma Co., Ltd. and reclassified related assets and liabilities as held for sale as of June 30, 2018, and sold the shares of the subsidiary in August 2018.

 

13

Commitments and Contingent Liabilities

Litigation

Takeda is involved in various legal and administrative proceedings. The significant matter during the six months period ended September 30, 2018 is described below. There are no significant updates from the consolidated financial statements as of and for the year ended March 31, 2018 except for the matter below.

 

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Amitiza

In March 2017, Sucampo Pharmaceuticals, Inc. (“Sucampo”) (Takeda’s licensor) received a paragraph IV certification directed to Amitiza from Amneal Pharmaceuticals, Inc. and in August 2017 received a paragraph IV certification directed to Amitiza from Teva Pharmaceutical Industries Ltd. These parties contend that the patents listed in The U.S. Food and Drug Administration’s Orange Book for Amitiza are invalid and/or not infringed by their Abbreviated New Drug Application product. In response, Sucampo and Takeda filed a patent infringement lawsuit against the parties. In June 2018, patent litigation against these parties has been settled.

 

14

Subsequent Events

On May 8, 2018, the Company reached agreement with Shire plc (“Shire”) on the terms of a recommended offer pursuant to which the Company will acquire the entire issued and to be issued ordinary shares of Shire (the “Acquisition”).

The Company has entered into a 364-Day Bridge Credit Agreement of 30.85 billion USD (the “Bridge Credit Agreement”) to finance funds necessary for the Acquisition on May 8, 2018. The commitments under the Bridge Credit Agreement are contemplated to be reduced or refinanced. On June 8, 2018, the Company has entered into a Term Loan Credit Agreement for an aggregate principal amount of up to 7.5 billion USD to finance a portion funds necessary for the Acquisition, and upon the execution thereof, the commitments under the Bridge Credit Agreement were reduced by up to 7.5 billion USD.

Further, on October 26, 2018, the Company has entered into a Senior Short Term Loan Facility Agreement for an aggregate principal amount of up to 500 billion JPY (the “SSTL”) to finance a portion of funds necessary for the Acquisition. Upon the execution of the SSTL, the commitments under the Bridge Credit Agreement were reduced by up to 4.5 billion USD. The Company has also entered into a Subordinated Syndicated Loan Agreement for an aggregate principal amount of up to 500 billion JPY to refinance the debt to be borrowed pursuant to the SSTL.

 

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