`
`Corporate Communications Group
`Tel: 06-4802-9360 Fax: 06-6359-3827
`E-mail: ir@santen.com
`Stock Code: 4536
`
`Micro Labs Exhibit 1059
`Micro Labs v. Santen Pharm. and Asahi Glass
`IPR2017-01434
`
`
`
` Contents
`
`
`
`Financial highlights
`■Consolidated financial summary
`
`
`■Consolidated balance sheets summary
`
`
`■Consolidated financial indexes
`
`
`■Exchange rates
`
`
`
`
`
`Consolidated information
`Consolidated statements of income and comprehensive income (IFRS, and Core basis)
`
`Consolidated statements of income and comprehensive income (J-GAAP)
`
`Net sales/Revenue details
`
`■Net sales/Revenue by business segment
`
`
`■Overseas net sales/revenue by region
`
`
`■Overseas profit contribution
`
`
`■Net Sales/Revenue of major pharmaceuticals
`
`
`Consolidated statement of financial position
`
`■Assets
`
`
`■Equity and liabilities
`
`
`Consolidated statements of cash flows
`
`Other consolidated information
`
`■R&D expenses
`
`
`■Capital expenditures
`
`
`■Depreciation and amortization
`
`
`■Amortization on intangible assets associated with products
`
`
`■Additional information of statement of financial position
`
`
`■Number of employees
`
`
`
`
`
`Reference information
`Research & development
`
`■Pipeline of prescription pharmaceuticals (Clinical stage)
`
`
`■Changes from Q3 FY16 (February 7, 2017)
`
`
`Pharmaceutical market in Japan
`
`■Revision of National Health Insurance (NHI) drug prices
`
`
`■Market shares
`
`
`■Market shares by therapeutic area - prescription ophthalmics
`
`
`Stock information
`
`■Stock price (Tokyo Securities Exchange 1st market)
`
`
`■Major shareholders (top 10)
`
`
`■Major stock information
`
`
`■Breakdown of shareholding by number of shares
`
`
`■Breakdown of shareholding by number of shareholders
`
`
`Consolidated subsidiaries
`
`News releases
`
`
`
`2
`2
`2
`2
`
`
`4
`5
`6
`6
`6
`6
`7
`8
`8
`9
`10
`11
`11
`11
`11
`11
`11
`11
`
`
`12
`12
`13
`14
`14
`14
`14
`15
`15
`15
`15
`16
`16
`17
`18
`
`
`Santen group has unified the accounting period from the fiscal year ended March 31, 2014, for voluntary adoption of
`International Financial Reporting Standards (IFRS) from the fiscal year ending March 31, 2015. In this data book,
`performance for the unification of accounting period is noted as (*), and financial results for the previous 12 month period
`are shown as [12month]. Financial results before the fiscal year ended March 31, 2013 are based on the previous 12
`month performance.
`Results contained in the column marked 2014[12month] provide precise and comparable 12 month results including for
`subsidiaries using different fiscal year periods.
`The company implemented a 5-for-1 stock split on April 1, 2015. Figures in the column 2014.3[IFRS] are adjusted
`assuming the new, post-split number of shares for comparison purposes.
`Forecasts in this report are based on the currently available information. Forecasts in this report are based on the
`currently available information. Actual results may differ materially depending on a number of factors including adverse
`economic conditions etc. Actual results may differ materially depending on a number of factors including adverse
`economic conditions, delays in new products launch, currency exchange rate, legislative and regulatory developments.
`
`- 1 -
`
`Micro Labs Exhibit 1059-2
`
`
`
` Financial highlights
`
`■Consolidated financial summary
`
`J-GAAP
`
`
`(Millions of yen)
`
`IFRS
`
`2018
`2017 % Change
`2016
`2015
`2014
`2014*
`2013
`Forecast
`119,066 148,663 146,260 161,831 195,291 199,096
`1.9 218,000
`24,681
`27,414
`29,878
`35,374
`80,180
`32,479
`(59.5)
`37,400
`16,520
`17,109
`19,718
`24,032
`53,373
`23,054
`(56.8)
`26,800
`
`-
`-
`
`-
`
`30,403
`19,813
`
`39,088
`25,948
`
`43,067
`29,163
`
`39,687
`28,688
`
`41.7
`
`35.0
`
`35.5
`
`37.2
`
`(7.8)
`(1.6)
`
`4.8
`
`44,000
`31,200
`
`33.6
`
`-
`
`(Millions of yen)
`
`Year ended March 31
`Net sales/Revenue
`Operating income/profit
`Net income/Net profit for the
`year
`26
`4.0
`26
`25
`22
`20
`20
`20
`Dividends per share (yen)#
`39.3
`138.7
`46.3
`19.4
`37.8
`41.9
`48.2
`51.1
`Dividend payout ratio (%)
`Notes: The company implemented a 5-for-1 stock split on April 1, 2015. Dividends per share have been retrospectively
`adujusted to reflect the impact of the share split..
`Core operating profit
`-
`Core net profit for the year
`-
`Core dividend payout ratio
`(%)
`
`■Consolidated balance sheets summary
`
`IFRS
`J-GAAP
`
`Year ended March 31
`2017 % Change
`2016
`2015
`2014
`2013
`2014*
`Total assets
`199,640 231,105 237,640 304,200 355,399 322,778
`(9.2)
`Equity
`165,132 181,209 187,210 211,779 260,009 253,884
`(2.4)
`Interest-bearing debts
`133
`110
`153
`37,161
`22,484
`16,963
`(24.6)
`
`■Consolidated financial indexes
`
`
`J-GAAP
`
`IFRS
`
`2014
`2014*
`2013
`[12month]
`229.26
`207.29
`195.81
`-
`-
`-
`1,998.44 2,189.50 2,234.70
`0.0
`0.0
`0.0
`22.7
`22.1
`20.0
`-
`-
`-
`2.2
`2.1
`2.1
`10.0
`9.9
`10.8
`-
`-
`-
`8.3
`7.9
`8.8
`82.6
`78.2
`79.3
`
`2014
`47.78
`48.01
`452.43
`0.0
`19.2
`19.1
`2.0
`11.1
`11.2
`8.9
`78.8
`
`2015
`58.18
`62.82
`511.14
`0.2
`30.1
`27.9
`3.4
`12.0
`13.0
`8.9
`69.6
`
`2016
`128.99
`70.48
`627.78
`0.1
`13.1
`24.0
`2.7
`22.6
`12.4
`16.2
`73.2
`
`2017 % Change
`56.20
`(56.4)
`69.93
`(0.8)
`623.06
`(0.8)
`0.1
`(22.1)
`28.7
`119.0
`23.1
`(3.8)
`2.6
`(3.7)
`9.0
`(60.2)
`11.2
`(9.7)
`6.8
`(58.0)
`78.4
`7.1
`
`6,334
`
`21,172
`
`-
`
`20,807 (41,054)
`
`13,433
`
`1,342
`
`(90.0)
`
`Year ended March 31
`EPS (yen)
`Core EPS (yen)
`BPS (yen) #1
`Debt equity ratio (times)
`PER (times)
`Core PER (times)
`PBR (times)
`ROE (%) #1
`Core ROE (%) #1
`ROA (%)
`Equity ratio(%) #1
`Free cash flows (millions of
`yen) #2
`0.1
`38,620
`38,596
`22,660
`22,565
`29,812
`28,255
`EBITDA (millions of yen) #3
`-
`#1 BPS (equity per share), ROE (return on equity), Core ROE and equity ratios are based on the IFRS inputs of equity
`per share attributable to owners of the company, net profit attributable to owners of the company, Core net profit
`attributable to owners of the company and equity attributable to owners of the company ratio.
`#2 Free cash flows = (Net cash flows from operating activities)-(Capital expenditures/Payments for acquisition of property,
` plant and equipment, and intangible assets)
`#3 EBITDA = J-GAAP: (Income before income taxes) + (Interest expense) + (Depreciation and amortization)
`IFRS: (Core profit for the year) + (Interest expense) + (Depreciation and amortization)
`
`■Exchange rates
`
`
`Year ended March 31
`Exchange rate: US dollar
`: Euro
`: CNY
`
`2013
`82.91
`106.01
`12.64
`
`2014*
`100.04
`132.98
`15.93
`
`
`
`2014
`[12month]
`100.04
`132.34
`15.72
`
`2015
`110.14
`139.01
`17.84
`
`2016
`120.45
`132.46
`19.05
`
`2017
`108.64
`118.96
`16.14
`
`(Yen)
`2018
`Forecast
`110.00
`120.00
`16.50
`
`- 2 -
`
`Micro Labs Exhibit 1059-3
`
`
`
` Financial highlights
`
`
`■Consolidated Financial summary (Graph)
`
`
`
`
`
`
`
`
`**J-GAAP
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`- 3 -
`
`
`
`
`
`
`
`
`
`Micro Labs Exhibit 1059-4
`
`
`
`Consolidated statements of income and
`comprehensive income
`
`
`■IFRS
`
`
`Year ended March 31
`
`2015
`
`2016
`
`2017
`
`Revenue
`Cost of sales
`(Percent of revenue)
`Gross profit
`(Percent of revenue)
`Selling, general and administrative expenses
`(Percent of revenue)
`Research and development expenses
`(Percent of revenue)
`Amortization on intangible assets associated
`with products
`(Percent of revenue)
`Other income
`Other expenses
`Operating profit
`(Percent of revenue)
`Finance income
`Finance expenses
`Profit before tax
`(Percent of revenue)
`Income tax expenses
`Net profit for the year
`(Percent of revenue)
`
`ROE (%)
`
`
`■IFRS (Core basis)
`
`
`161,831
`(56,373)
`34.8%
`105,458
`65.2%
`(48,893)
`30.2%
`(17,477)
`10.8%
`
`(3,979)
`
`2.5%
`723
`(458)
`35,374
`21.9%
`768
`(279)
`35,863
`22.2%
`(11,831)
`24,032
`14.9%
`
`12.0
`
`195,291
`(72,829)
`37.3%
`122,463
`62.7%
`(59,406)
`30.4%
`(19,990)
`10.2%
`
`(6,205)
`
`3.2%
`44,999
`(1,681)
`80,180
`41.1%
`782
`(1,492)
`79,470
`40.7%
`(26,097)
`53,373
`27.3%
`
`22.6
`
`199,096
`(74,966)
`37.7%
`124,130
`62.3%
`(62,193)
`31.2%
`(22,786)
`11.4%
`
`(6,412)
`
`3.2%
`468
`(728)
`32,479
`16.3%
`909
`(1,565)
`31,822
`16.0%
`(8,768)
`23,054
`11.6%
`
`9.0
`
`Year ended March 31
`
`2015
`
`2016
`
`2017
`
`Revenue
`Cost of sales
`(Percent of revenue)
`Gross profit
`(Percent of revenue)
`Selling, general and administrative expenses
`(Percent of revenue)
`Research and development expenses
`(Percent of revenue)
`Operating profit
`(Percent of revenue)
`Profit before tax
`(Percent of revenue)
`Income tax expenses
`Net profit for the year
`(Percent of revenue)
`
`ROE (%)
`
`
`
`195,291
`(72,829)
`37.3%
`122,463
`62.7%
`(59,406)
`30.4%
`(19,990)
`10.2%
`43,067
`22.1%
`43,067
`22.1%
`(13,904)
`29,163
`14.9%
`
`12.4
`
`199,096
`(74,966)
`37.7%
`124,130
`62.3%
`(61,657)
`31.0%
`(22,786)
`11.4%
`39,687
`19.9%
`39,687
`19.9%
`(10,999)
`28,688
`14.4%
`
`11.2
`
`161,831
`(56,373)
`34.8%
`105,458
`65.2%
`(48,893)
`30.2%
`(17,477)
`10.8%
`39,088
`24.2%
`39,088
`24.2%
`(13,140)
`25,948
`16.0%
`
`13.0
`
`- 4 -
`
`(Millions of yen)
`
`% Change
`2017/2016
`1.9
`2.9
`-
`1.4
`-
`4.7
`-
`14.0
`-
`
`3.3
`
`-
`(99.0)
`(56.7)
`(59.5)
`-
`16.2
`4.9
`(60.0)
`-
`(66.4)
`(56.8)
`-
`
`-
`
`(Millions of yen)
`% Change
`2017/2016
`1.9
`2.9
`-
`1.4
`-
`3.8
`-
`14.0
`-
`(7.8)
`-
`(7.8)
`-
`(20.9)
`(1.6)
`-
`
`-
`
`Micro Labs Exhibit 1059-5
`
`
`
`Consolidated statements of income and
`comprehensive income
`
`
`■J-GAAP
`
`
`Year ended March 31
`
`2013
`
`2014*
`
`2014
`[12month]
`146,013
`57,171
`39.2%
`88,842
`60.8%
`
`(Millions of yen)
`
`2015
`
`161,881
`56,423
`34.9%
`105,458
`65.1%
`
`% Change
`2016/2015
`10.9
`(1.3)
`
`18.7
`
`
`119,066
`41,501
`34.9%
`77,564
`65.1%
`
`148,663
`58,104
`39.1%
`90,558
`60.9%
`
`Net sales
`Cost of sales
`(Percent of net sales)
`Gross profit
`(Percent of net sales)
`Selling, general and administrative
`expenses
`(Percent of net sales)
`R&D expenditures
`(Percent of net sales)
`Operating income
`(Percent of net sales)
`Non-operating income
`Non-operating expenses
`Ordinary income
`(Percent of net sales)
`Extraordinary gain
`Extraordinary loss
`Income before income taxes
`(Percent of net sales)
`Income taxes - current
`Income taxes - deferred
`Income before minority interests
`Net income
`(Percent of net sales)
`Income before minority interests
`Other comprehensive income
`Comprehensive income
`
`
`
`
`
`52,883
`
`63,144
`
`60,006
`
`71,942
`
`44.4%
`16,719
`14.0%
`24,681
`20.7%
`1,007
`86
`25,602
`21.5%
`17
`28
`25,591
`21.5%
`7,908
`1,162
`16,520
`16,520
`13.9%
`16,520
`5,208
`21,728
`
`42.5%
`19,040
`12.8%
`27,414
`18.4%
`975
`465
`27,924
`18.8%
`473
`1,504
`26,893
`18.1%
`11,762
`(1,978)
`17,109
`17,109
`11.5%
`17,109
`8,269
`25,378
`
`41.1%
`18,235
`12.5%
`28,835
`19.7%
`952
`455
`29,332
`20.1%
`473
`1,014
`28,792
`19.7%
`11,255
`(1,385)
`18,922
`18,922
`13.0%
`18,922
`10,188
`29,111
`
`44.4%
`18,062
`11.2%
`33,516
`20.7%
`1,333
`333
`34,516
`21.3%
`155
`344
`34,327
`21.2%
`12,600
`(843)
`22,570
`22,570
`13.9%
`22,570
`8,708
`31,278
`
`19.9
`
`
`(0.9)
`
`16.2
`
`40.0
`(26.8)
`17.7
`
`(67.2)
`(66.1)
`19.2
`
`12.0
`(39.1)
`19.3
`19.3
`
`19.3
`(14.5)
`7.4
`
`- 5 -
`
`Micro Labs Exhibit 1059-6
`
`
`
` Net sales/Revenue details
`
`
`■Net sales/Revenue by business segment
`
`
`J-GAAP
`
`Year ended March 31
`
`Pharmaceuticals Business
`Prescription pharmaceuticals
`Ophthalmics
`Anti-rheumatics
`Other pharmaceuticals
`OTC pharmaceuticals
`Other Businesses
`Medical devices
`Others
`Total net sales/revenue
`
`[Domestic]
`
`
`Year ended March 31
`
`Pharmaceuticals Business
`Prescription pharmaceuticals
`Ophthalmics
`Anti-rheumatics
`Other pharmaceuticals
`OTC pharmaceuticals
`Other Businesses
`Medical devices
`Others
`Total net sales/revenue
`(Percent of total net sales/revenue)
`
`[Overseas]
`
`
`Year ended March 31
`
`2013
`
`2014*
`
`116,810
`110,336
`98,981
`9,874
`1,480
`6,474
`2,255
`2,245
`10
`119,066
`
`145,712
`139,257
`127,395
`10,251
`1,610
`6,455
`2,950
`2,678
`272
`148,663
`
`J-GAAP
`
`2013
`
`2014*
`
`98,521
`92,062
`81,125
`9,810
`1,126
`6,458
`2,189
`2,178
`10
`100,711
`84.6%
`
`119,215
`112,798
`101,779
`10,162
`856
`6,417
`2,897
`2,625
`272
`122,113
`82.1%
`
`J-GAAP
`
`2013
`
`2014*
`
`18,288
`Pharmaceuticals Business
`18,273
`Prescription pharmaceuticals
`17,855
`Ophthalmics
`63
`Anti-rheumatics
`354
`Other pharmaceuticals
`15
`OTC pharmaceuticals
`66
`Other Businesses
`66
`Medical devices
`Others
`-
`18,354
`Total net sales/revenue
`15.4%
`(Percent of total net sales/revenue)
`
`■Overseas net sales/revenue by region
`
`J-GAAP
`
`26,497
`26,459
`25,616
`88
`754
`37
`52
`52
`-
`26,550
`17.9%
`
`2014
`[12month]
`143,063
`136,610
`124,790
`10,251
`1,569
`6,453
`2,950
`2,678
`272
`146,013
`
`2014
`[12month]
`119,184
`112,767
`101,779
`10,162
`825
`6,417
`2,897
`2,625
`272
`122,082
`83.6%
`
`2014
`[12month]
`23,878
`23,843
`23,010
`88
`743
`35
`52
`52
`-
`23,931
`16.4%
`
`2015
`
`2016
`
`159,262
`152,556
`136,059
`9,629
`6,868
`6,706
`2,569
`2,313
`256
`161,831
`
`192,554
`181,550
`172,545
`3,495
`5,510
`11,004
`2,737
`2,394
`343
`195,291
`
`2015
`
`2016
`
`122,310
`115,672
`105,345
`9,568
`759
`6,638
`2,526
`2,269
`256
`124,835
`77.1%
`
`139,196
`128,278
`124,165
`3,495
`617
`10,918
`2,654
`2,323
`330
`141,849
`72.6%
`
`2015
`
`2016
`
`36,952
`36,884
`30,714
`61
`6,109
`67
`44
`44
`-
`36,995
`22.9%
`
`53,358
`53,271
`48,379
`-
`4,892
`87
`84
`71
`13
`53,442
`27.4%
`
`IFRS
`
`2017
`
`196,023
`183,469
`181,859
`-
`1,610
`12,553
`3,073
`2,536
`537
`199,096
`
`IFRS
`
`2017
`
`142,439
`130,018
`129,594
`-
`424
`12,421
`2,919
`2,514
`404
`145,358
`73.0%
`
`IFRS
`
`2017
`
`53,584
`53,451
`52,265
`-
`1,186
`132
`154
`22
`132
`53,738
`27.0%
`
`IFRS
`
`Year ended March 31
`
`North America
`EMEA#1
`Asia
`Others
`Total overseas net sales/revenue
`
`■Overseas profit contribution
`
`
`2013
`
`2014*
`
`2014
`
`2015
`
`2016
`
`2017
`
`582
`9,202
`8,559
`10
`18,354
`
`1,073
`12,294
`13,173
`8
`26,550
`
`1,016
`11,466
`11,700
`7
`24,188
`
`6,169
`14,156
`16,668
`2
`36,995
`
`5,265
`25,562
`22,601
`14
`53,442
`
`1,433
`28,521
`23,738
`46
`53,738
`
`Year ended March 31
`
`-
`
`-
`
`2014
`
`2015
`
`2016
`
`2017
`
`North America
`EMEA#1
`Asia
`Others
`Total overseas profit
`#1 Europe, the Middle East and Africa
`
`-
`-
`-
`-
`-
`
`-
`-
`-
`-
`-
`
`(1,662)
`(81)
`1,087
`0
`(656)
`
`(2,033)
`(734)
`3,181
`0
`414
`
`(2,959)
`817
`4,777
`0
`2,636
`
`(3,424)
`3,514
`4,912
`0
`5,001
`
`(Millions of yen)
`
`2018
`%
`Forecast
`Change
`1.8%
`214,518
`1.1%
`201,618
`3.3%
`200,561
`-
`-
`(70.8)%
`1,056
`14.1%
`12,900
`12.3%
`3,482
`2,858
`5.9%
`624
`56.5%
`1.9%
`218,000
`(Millions of yen)
`
`%
`2018
`Change
`Forecast
`2.3%
`152,521
`1.4%
`139,898
`4.4%
`139,475
`-
`-
`(31.3)%
`423
`13.8%
`12,623
`10.0%
`3,268
`8.2%
`2,800
`22.5%
`468
`2.5%
`155,789
`71.5%
`-
`(Millions of yen)
`
`2018
`%
`Forecast
`Change
`61,997
`0.4%
`61,720
`0.3%
`61,086
`8.0%
`-
`-
`633
`(75.8)%
`278
`52.6%
`214
`84.3%
`58
`(69.0)%
`156
`923.8%
`62,211
`0.6%
`28.5%
`-
`(Millions of yen)
`
`2018
`%
`Forecast
`Change
`(72.8)%
`1,027
`11.6%
`31,825
`5.0%
`29,072
`224.0%
`288
`62,211
`0.6%
`(Millions of yen)
`2018
`Forecast
`(5,913)
`6,812
`7,146
`0
`8,045
`
`%
`Change
`15.7%
`330.1%
`2.8%
`-
`89.8%
`
`- 6 -
`
`Micro Labs Exhibit 1059-7
`
`
`
` Net sales/Revenue details
` ■Net sales/Revenue of major prescription pharmaceuticals
`
`Brand name
`Therapeutic
`Generic name/formulation
`category
`
`Region
`
`(Millions of yen)
`
`IFRS
`J-GAAP
`2013 2014* 2014 2015 2016 2017 % Change
`2018
`Forecast
`2016/2015
`11,856 14,210 13,584 13,399 14,250 12,884
`(9.6) 13,945
`Total
`8,499 8,175 8,175 6,498 5,918 4,660
`(21.3)
`4,308
`Japan
`2,358 4,670 4,139 5,423 7,001 6,980
`(0.3)
`8,252
`Asia
`Europe 1,010 1,364 1,270 1,478 1,331 1,245
`(6.5)
`1,384
`Total
`1,831 2,040 1,924 1,910 1,761 1,541
`(12.5)
`1,455
`Japan
`1,086
`955
`955
`762
`673
`559
`(16.9)
`472
`Asia
`745 1,085
`969 1,147 1,088
`982
`(9.8)
`983
`Total
`381 1,534 2,798
`82.4
`3,800
`-
`-
`-
`Japan
`342 1,381 2,256
`63.4
`2,587
`-
`-
`-
`Asia
`38
`90
`-
`-
`-
`-
`-
`-
`Europe
`39
`153
`504
`229.3
`1,124
`-
`-
`-
`Total
`10,308 12,731 12,516 12,330 15,633 16,406
`4.9 18,115
`Japan
`7,605 8,957 8,957 8,329 9,168 9,592
`4.6 10,489
`Asia
`268
`553
`520
`817 1,097 1,227
`11.8
`1,613
`Europe 2,435 3,221 3,040 3,185 5,368 5,587
`4.1
`5,985
`Other
`28
`-
`-
`-
`-
`-
`-
`-
`Total
`9,007 11,846 11,846 12,478 20,583 22,164
`7.7 23,013
`Japan
`9,007 11,846 11,846 10,689 11,214 11,366
`1.4 11,468
`Asia
`892 2,493 2,669
`7.1
`2,913
`-
`-
`-
`Europe
`897 6,876 8,122
`18.1
`8,476
`-
`-
`-
`Other
`6
`156
`-
`-
`-
`-
`-
`-
`Total
`1,367 1,185 1,185 1,267 1,930 1,509
`(21.8)
`1,430
`Japan
`1,367 1,185 1,185 1,216 1,182
`967
`(18.1)
`853
`Asia
`29
`140
`119
`(14.8)
`182
`-
`-
`-
`Europe
`22
`608
`422
`(30.6)
`395
`-
`-
`-
`Total
`2,085 1,931 1,931 1,984 2,463 2,382
`(3.3)
`2,179
`Japan
`2,085 1,931 1,931 1,918 1,886 1,614
`(14.4)
`1,450
`Asia
`27
`87
`88
`0.8
`42
`-
`-
`-
`Europe
`39
`489
`679
`38.8
`687
`-
`-
`-
`Total
`- 1,853 4,561 4,343
`(4.8)
`3,906
`-
`-
`Japan
`- 1,545 2,125 1,731
`(18.6)
`1,396
`-
`-
`Asia
`55
`446
`271
`(39.3)
`280
`-
`-
`-
`Europe
`252 1,990 2,333
`17.2
`2,194
`-
`-
`-
`Other
`9
`36
`-
`-
`-
`-
`-
`-
`
`Glaucoma
`
`Japan
`
`1,735 1,549 1,549 1,228 1,117 1,054
`
`(5.6)
`
`926
`
`Glaucoma
`
`Japan
`
`2,243 2,147 2,147 1,935 1,845 1,633
`
`(11.5)
`
`1,641
`
`Allergy
`
`Japan
`
`- 2,103 2,103 6,698 9,483 12,235
`
`29.0 14,926
`
`Cravit
`levofloxacin/ophthalmic solution
`
`Tarivid
`ofloxacin/ophthalmic solution
`
`Tapcom
`tafluprost-timolol maleate/
` combination ophthalmic solution
`
`Bacterial
`conjunctivitis
`
`Bacterial
`conjunctivitis
`
`Glaucoma
`
`Tapros
`tafluprost/ophthalmic solution
`
`Glaucoma
`
`Cosopt
`dorzolamide hydrochloride-timolol
` maleate/combination ophthalmic
` solution
`
`Glaucoma
`
`Timoptol
`timolol maleate/ ophthalmic solution
`
`Glaucoma
`
`Glaucoma
`
`Glaucoma
`
`Timoptol XE
`timolol maleate/
` long-acting ophthalmic solution
`
`Trusopt
`dorzolamide hydrochloride/
` ophthalmic solution
`
`Detantol
`bunazosin hydrochloride/
` ophthalmic solution
`Rescula
`isopropyl unoprostone/
` ophthalmic solution
`Alesion
`epinastine hydrochloride/
` ophthalmic solution
`Flumetholon
`fluorometholone/ ophthalmic solution
`
`Inflammation
`
`Senile cataract
`
`Total
`Japan
`Asia
`Total
`Japan
`Asia
`
`Japan
`
`4,448 3,973 3,899 3,811 3,775 3,347
`3,736 3,075 3,075 2,844 2,655 2,224
`712
`898
`823
`967 1,120 1,123
`3,766 4,060 3,978 3,909 4,187 4,124
`3,107 3,162 3,162 2,908 2,900 2,833
`659
`898
`816 1,001 1,287 1,291
`
`(11.3)
`(16.2)
`0.3
`(1.5)
`(2.3)
`0.3
`
`3,425
`2,123
`1,302
`4,439
`2,776
`1,663
`
`2,842 2,868 2,868 2,574 2,568 2,285
`
`(11.0)
`
`2,288
`
`3,183 18,757 18,757 24,886 39,988 45,155
`
`12.9 46,199
`
`Kary Uni
`pirenoxine/ ophthalmic solution
`Opegan Hi
`sodium hyaluronate/
` adjuvant for ophthalmic operations
`Eylea
`aflibercept/
` soulution for intravitreal injection
`Hyalein
`sodium hyaluronate/ophthalmic solution Dry eye
`
`Adjuvant for
`ophthalmic
`operations
`Intravitreal
`VEGF inhibitor Japan
`(11.4) 17,483
`21,160 21,823 21,416 19,611 19,864 17,595
`Total
`(18.2) 10,743
`Japan 18,274 18,179 18,179 15,316 14,491 11,852
`6.9
`6,740
`Asia
`2,886 3,645 3,237 4,295 5,372 5,743
`24.0 14,574
`Total
`5,563 7,938 7,938 7,895 9,631 11,940
`24.1 12,642
`Japan
`5,563 7,831 7,831 7,419 8,880 11,016
`23.1
`1,932
`Asia
`106
`107
`476
`751
`924
`-
`73.5
`2,344
`Total
`751 1,303
`-
`-
`-
`-
`64
`Asia
`2
`-
`-
`-
`-
`-
`-
`73.2
`2,226
`Europe
`751 1,301
`-
`-
`-
`-
`North
`49
`-
`-
`-
`-
`-
`-
`-
`America
`6
`Other
`-
`-
`-
`-
`-
`-
`-
`26.3%
`2,587
`Total
`- 1,835
`-
`-
`-
`-
`23.4%
`344
`Asia
`206
`-
`-
`-
`-
`-
`28.1%
`1,894
`Europe
`- 1,318
`-
`-
`-
`-
`North
`15.7%
`287
`280
`-
`-
`-
`-
`-
`America
`Other
`31 114.9%
`62
`-
`-
`-
`-
`-
`6,474 6,455 6,453 6,706 11,004 12,553
`14.1% 12,900
`OTC pharmaceuticals
`
`Year to March 2017
`Year to March 2018(Forecasts)
`Year to March 2016
`Currency
`Exchange rates
`108.64
`110.00
`120.45
`US dollar
`
`118.96
`120.00
`132.46
`Euro
`
`16.14
`16.50
`19.05
`CNY
`
`Nots: Forecasts in this report are based on the currently available information. Actual results may differ materially depending on a number of factors including adverse economic
`conditions, etc.
`
`Diquas
`diquafosol sodium/ophthalmic solution
`
`Dry eye
`
`Ikervis
` ciclosporin/ophthalmic solution
`
`Dry eye
`
`Cationorm
`
`Dry eye
`
`- 7 -
`
`Micro Labs Exhibit 1059-8
`
`
`
` Consolidated statement of financial position
`
`
`■Assets
`
`Year ended March 31
`
`
`Non-current assets
`Property, plant and equipment
`Intangible assets
`Financial assets
`Deferred tax assets
`Other non-current assets
`Total non-current assets
`
`Current assets
`Inventories
`Trade and other receivables
`Other financial assets
`Other current assets
`Cash and cash equivalents
`Total current assets
`
`
`
`
`
`
`
`
`
`
`
`
`2015
`
`
`
`
`29,104
`84,433
`34,725
`2,978
`2,288
`153,528
`
`
`
`20,133
`61,701
`187
`2,728
`65,923
`150,672
`
`
`
`
`
`
`
`
`
`
`
`
`
`%
`9.6
`27.8
`11.4
`1.0
`0.8
`50.5
`
`
`
`6.6
`20.3
`0.1
`0.9
`21.7
`49.5
`
`
`
`
`
`
`
`
`
`
`
`
`(Millions of yen)
`
`2016
`
`
`
`
`27,991
`83,681
`44,535
`2,345
`2,109
`160,660
`
`
`
`24,996
`65,998
`234
`3,714
`99,798
`194,739
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`%
`7.9
`23.5
`12.5
`0.7
`0.6
`45.2
`
`
`
`7.0
`18.6
`0.1
`1.0
`28.1
`54.8
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`2017
`
`
`
`
`28,550
`102,807
`29,889
`2,396
`2,124
`165,767
`
`
`
`28,502
`70,970
`333
`3,909
`53,297
`157,011
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`%
`8.9
`31.9
`9.3
`0.7
`0.7
`51.4
`
`
`
`8.8
`22.0
`0.1
`1.2
`16.5
`48.6
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Total assets
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`304,200
`
`
`100.0
`
`
`355,399
`
`
`100.0
`
`
`322,778
`
`
`100.0
`
`- 8 -
`
`Micro Labs Exhibit 1059-9
`
`
`
`
`
`
`
`■Equity and liabilities
`
`
`Year ended March 31
`
`
`Equity
`Share capital
`Capital surplus
`Treasury shares
`Retained earnings
`Other components of equity
`Total equity attributable to owners
`of the company
`Non-controlling interests
`
`Total equity
`
`Liabilities
`Non-current liabilities
`Financial liabilities
`Net defined benefit liabilities
`Provisions
`Deferred tax liabilities
`Other non-current liabilities
`Total non-current liabilities
`
`Current liabilities
`Trade and other payables
`Other financial liabilities
`Income tax payable
`Provisions
`Other current liabilities
`Total current liabilities
`
`Total liabilities
`
`
`
`Total equity and liabilities
`
`
`
`(Millions of yen)
`
`2015
`
`
`
`
`7,383
`8,077
`(18)
`178,840
`17,497
`
`2016
`
`
`
`
`7,695
`8,389
`(24)
`221,945
`22,003
`
`
`%
`2.4
`2.7
`(0.0)
`58.8
`5.8
`
`2017
`
`
`
`
`7,792
`8,417
`(10)
`223,418
`13,448
`
`
`%
`2.2
`2.4
`(0.0)
`62.4
`6.2
`
`211,779
`
`69.6
`
`260,009
`
`73.2
`
`253,065
`
`-
`
`
`211,779
`
`
`
`
`25,351
`5,459
`1,444
`2,874
`953
`36,081
`
`
`
`20,250
`19,298
`6,729
`1,197
`8,866
`56,340
`
`92,421
`
`
`-
`
`
`69.6
`
`
`
`
`8.3
`1.8
`0.5
`0.9
`0.3
`11.9
`
`
`
`6.7
`6.3
`2.2
`0.4
`2.9
`18.5
`
`30.4
`
`
`-
`
`
`260,009
`
`
`
`
`12,944
`2,556
`1,629
`3,988
`1,043
`22,161
`
`
`
`24,504
`19,881
`20,431
`1,276
`7,138
`73,230
`
`95,391
`
`
`-
`
`
`73.2
`
`
`
`
`3.6
`0.7
`0.5
`1.1
`0.3
`6.2
`
`
`
`6.9
`5.6
`5.7
`0.4
`2.0
`20.6
`
`26.8
`
`
`819
`
`253,884
`
`
`
`
`7,619
`1,900
`1,426
`2,596
`1,919
`15,460
`
`
`
`23,937
`17,603
`3,279
`1,372
`7,244
`53,434
`
`68,894
`
`
`
`%
`2.4
`2.6
`(0.0)
`69.2
`4.2
`
`78.4
`
`0.3
`
`78.7
`
`
`
`
`2.4
`0.6
`0.4
`0.8
`0.6
`4.8
`
`
`
`7.4
`5.5
`1.0
`0.4
`2.2
`16.6
`
`21.3
`
`
`
`304,200
`
`
`100.0
`
`
`355,399
`
`
`100.0
`
`
`322,778
`
`
`100.0
`
`- 9 -
`
`Micro Labs Exhibit 1059-10
`
`
`
` Consolidated statements of cash flows
`
`
`
`
`
`
`
`Year ended March 31
`Ⅰ. Cash flows from operating activities:
`Net profit for the year
`Depreciation and amortization
`Impairment losses
`Finance income and expenses
`Income tax expenses
`Gain on disposal of disposal groups
`Decrease (increase) in trade and other receivables
`Decrease (increase) in inventories
`Increase (decrease) in trade and other payables
`Increase (decrease) on net defined benefit liabilities
`Other
`Subtotal
`Interest received
`Dividends received
`Interest paid
`Income tax paid
`Net cash flows from (used in) operating activities
`
`
`Ⅱ. Cash flows from investing activities:
`Payments into time deposits
`Proceeds from withdrawal of time deposits
`Payments for acquisition of investments
`Proceeds from sale and redemption of investments
`Increase (decrease) through acquisition of subsidiary
`Payments for acquisition of property, plant and equipment
`Proceeds from sales of property, plant and equipment
`Payments for acquisition of intangible assets
`Proceeds on disposal of disposal groups
`Other
`Net cash flows from (used in) investing activities
`
`
`Ⅲ. Cash flows from financing activities:
`Proceeds from short-term loans payable
`Repayments of short-term loans payable
`Proceeds from long-term loans payable
`Repayments of long-term loans payable
`Acquisition of treasury shares
`Proceeds from contributions of non-controlling interests
`Dividends paid
`Other
`Net cash flows from (used in) financing activities
`Ⅳ. Net increase (decrease) in cash and cash equivalents
`Ⅴ. Cash and cash equivalents at the beginning of year
`Ⅵ. Effect of exchange rate changes on cash and cash
`equivalents
`Ⅶ. Cash and cash equivalents at the end of period
`
`- 10 -
`
`2015
`
`2016
`
`(Millions of yen)
`2017
`
`
`24,032
`6,958
`290
`(529)
`11,831
`-
`(7,701)
`(521)
`1,251
`761
`2,554
`38,926
`81
`548
`(82)
`(14,087)
`25,386
`
`
`
`(84)
`184
`(114)
`4,149
`-
`(2,972)
`656
`(63,468)
`-
`(60)
`(61,709)
`
`
`
`35,000
`(35,000)
`40,000
`(2,970)
`-
`
`-
`(8,264)
`194
`28,960
`(7,363)
`72,397
`
`889
`
`65,923
`
`
`53,373
`9,338
`395
`(545)
`26,097
`(44,477)
`(4,799)
`(5,388)
`4,376
`(3,974)
`653
`35,049
`67
`573
`(98)
`(13,067)
`22,525
`
`
`
`(21)
`21
`(2,210)
`2,682
`-
`(4,299)
`696
`(4,793)
`45,000
`(25)
`37,052
`
`
`
`
`-
`
`-
`500
`(15,133)
`-
`
`-
`(9,923)
`489
`(24,066)
`35,510
`65,923
`
`(1,636)
`
`99,798
`
`
`23,054
`9,882
`475
`1,180
`8,768
`-
`(5,489)
`(4,120)
`(425)
`(200)
`913
`34,039
`74
`681
`(52)
`(23,900)
`10,843
`
`
`
`
`-
`19
`(478)
`1,364
`(19,064)
`(4,145)
`4
`(5,355)
`-
`(545)
`(28,201)
`
`
`
`
`-
`
`-
`3,000
`(9,524)
`(12,380)
`832
`(10,751)
`167
`(28,657)
`(46,015)
`99,798
`
`(1,501)
`
`52,282
`
`Micro Labs Exhibit 1059-11
`
`
`
` Other consolidated information
`
`
`■R&D expenses
`
`
`
`J-GAAP
`
`IFRS
`
`(Millions of yen)
`
`Year ended March 31
`
`2013
`
`2014*
`
`2015
`
`2016
`
`2017
`
`16,719
`14.0%
`
`19,040
`12.8%
`
`17,477
`10.8%
`
`19,990
`10.2%
`
`22,786
`11.4%
`
`J-GAAP
`
`IFRS
`
`(Millions of yen)
`
`2018
`Forecast
`25,000
`11.5%
`
`2018
`Forecast
`7,660
`
`Consolidated
`Percent of net sales/revenue
`
`
`■Capital expenditures
`
`
`
`Consolidated
`
`
`■Depreciation and amortization
`
`
`
`Year ended March 31
`
`2013
`
`2014*
`
`2015
`
`2016
`
`2017
`
`4,202
`
`3,155
`
`5,383
`
`4,474
`
`5,216
`
`J-GAAP
`
`IFRS
`
`(Millions of yen)
`
`Year ended March 31
`
`2013
`
`2014*
`
`2015
`
`2016
`
`2017
`
`1,211
`
`533
`
`1,330
`
`648
`
`Manufacturing cost
`Selling, general and administrative
`expenses
`668
`634
`785
`R&D expenses
`2,979
`2,612
`2,530
`Consolidated total
`Note: Excluding amortization of intangible assets and long-term advance expense
`
`■Amortization on intangible assets associated with products
`
`J-GAAP
`
`
`1,446
`
`864
`
`1,445
`
`1,035
`
`653
`3,133
`
`1,515
`
`1,246
`
`709
`3,470
`
`2018
`Forecast
`1,880
`
`1,270
`
`680
`3,830
`
`(Millions of yen)
`
`IFRS
`
`Year ended March 31
`
`2013
`
`2014*
`
`2015
`
`2016
`
`2017
`
`Intangible assets (Merck products)
`Intangible assets (Ikervis)
`Other
`Consolidated total
`
`-
`-
`-
`-
`
`-
`-
`-
`-
`
`3,734
`-
`245
`3,979
`
`5,185
`625
`394
`6,205
`
`5,357
`674
`381
`6,412
`
`2018
`Forecast
`5,590
`680
`350
`6,620
`
`
`■Additional information of statement of financial position
`
`J-GAAP
`
`2013
`2014*
`Year ended March 31
`In-process research and development
`-
`-
`Investment securities
`18,173
`21,739
`Notes and accounts receivable
`43,840
`52,086
`Notes and accounts payable
`9,266
`14,270
`
`
`
`■Number of employees
`Year ended March 31
`
`Japan
`North America
`EMEA#1
`Asia
`Consolidated
`
`
`#1 Europe, the Middle East and Africa
`
`2013
`1,925
`156
`511
`458
`3,050
`
`2014*
`1,903
`154
`530
`485
`3,072
`
`(Millions of yen)
`
`2015
`16,145
`33,634
`59,611
`14,330
`
`2015
`1,923
`162
`588
`557
`3,230
`
`IFRS
`2016
`11,363
`43,413
`63,954
`17,225
`
`2016
`1,915
`175
`660
`713
`3,463
`
`2017
`11,543
`28,615
`68,829
`17,883
`
`2017
`1,975
`213
`669
`810
`3,667
`
`- 11 -
`
`Micro Labs Exhibit 1059-12
`
`
`
` Research & development
`
`
`■Pipeline of prescription pharmaceuticals (Clinical stage)
`Generic name
`Dev. code
`Indication
`Original/Licensor Region P1
`Glaucoma/
`Co-development
`Ocular hypertension
`with Asahi Glass
`A prostaglandin F2α derivative for the treatment of glaucoma and ocular hypertension. Since December, 2008, launched in Japan, Europe and
`Asia. Launched in China in March 2016.
`
`Tafluprost
`
`DE-085
`
`China
`
`
`
`
`
`
`
`
`
` Mar-16
`
`P2
`
`P3 NDA Filed Approved Launched
`
`
`
`
`
`
`
`
`
`
`
`Generic name
`
`Dev. code
`
`Indication
`
`Diquafosol sodium DE-089
`
`Dry eye
`
`P3 NDA Filed Approved Launched
`P2
`Original/Licensor Region P1
` Jan-12
`China
`Merck Sharp &
`
`
`
`
`Dohme Corp. (U.S.)
` Feb-16
`Asia
`
`
`
`
`A dry eye treatment which stimulates secretion of mucin and aqueous components from the corneal and conjunctival epithelium. Its mechanism
`of action is different from existing treatments. Launched in December 2010 in Japan. NDA filed in China in January 2012. Launched in October
`2013 in Korea. Launched in Vietnam in February 2016. Launched in Thailand in April 2016. Currently seeking sequential approvals for
`marketing in Asia.
`
`Generic name
`
`Dev. code
`
`Indication
`
`Sirolimus
`
`DE-109
`
`Uveitis
`
`Original
`
`P3 NDA Filed Approved Launched
`P2
`Original/Licensor Region P1
` Feb-17
`U.S.
`
`
`
`
`Japan
`
`
`
`
`
`
`Europe
`
`
`
`
`
`
` Apr-15
`Asia
`
`
`
`
`An intravitreal injection with immunosuppressive effect, anti-angiogenic effect, etc. NDA filed in the US in February 2017. Preparing NDA file in
`Europe. NDA filed in Asia in April 2015.
`
`Dev. code
`
`DE-111
`
`Original/Licensor Region P1
`Indication
`Generic name
`Tafluprost/
`Co-development
`Glaucoma/
`Timolol maleate
`with Asahi Glass
`Ocular hypertension
`A fixed dose combination drug of a prostaglandin F2α derivative and a beta-adrenergic receptor blocker. Launched in Japan in November 2014.
`Launched successively in European countries since October 2014 and launched since January 2015. Launched in Korea in April 2016. NDA
`filed in Asian countries successively, and approved in some countries including Thailand.
`
`P2
`
`P3 NDA Filed Approved Launched
`
`Asia
`
`
`
`
`
`
`
`
`
` Apr-16
`
`Generic name
`
`Dev. code
`
`Indication
`
`omidenepag
`isopropyl
`
`DE-117
`
`Glaucoma/
`Ocular hypertension
`
`Co-development
`with Ube Industries
`
`P3 NDA Filed Approved Launched
`P2
`Original/Licensor Region P1
`U.S.
`
`
`
`
`
`
`(Phase 2b/3)
`Japan
`
`
`
`
`Asia
`
`
`
`
`
`
`An EP2 receptor agonist with a new mechanism of action. Completed Phase 2b in the U.S in February 2015. Started Phase 2b/3 in Japan in
`December 2015. Started Phase 3 in Asia in December 2016.
`
`Generic name
`
`Dev. code
`
`P2
`
`P3 NDA Filed Approved Launched
`
`
`
`Tafluprost
`
`DE-118
`
`Original/Licensor Region P1
`Indication
`Co-development
`Glaucoma/
`with Asahi Glass
`Ocular hypertension
`A prostaglandin F2α derivative for the treatment of glaucoma and ocular hypertension. Preservative-free, single dose type product. Launched in
`Japan in October 2013. Launched in Asian countries since April, 2016.
`
`Asia
`
`
`
`
`
`
`
` Apr-16
`
`Generic name
`
`Dev. code
`
`carotuximab
`
`DE-122
`
`Original/Licensor Region P1
`Indication
`TRACON
`Wet Age-related
`Pharmaceuticals
`macular degeneration
`An intravitreal injection of anti-endoglin antibody. Started Phase1/2 in the U.S. in September 2015 and preparing Phase 2a.
`
`P2
`
`P3 NDA Filed Approved Launched
`
`U.S.
`
`(Phase 1/2)
`
`
`
`
`
`
`
`
`
`Generic name
`
`Dev. code
`
`Sepetaprost
`
`DE-126
`
`Original/Licensor Region P1
`Indication
`ONO
`Glaucoma/
`PHARMACEUTICAL
`Ocular hypertension
`A prostaglandin analogue eye drop drug product with a novel, mode of action that is both FP and EP3 receptors dual agonist for the treatment
`of glaucoma and ocular hypertension. Preparing Phase 2b in the U.S. and Japan.
`
`P2
`
`P3 NDA Filed Approved Launched
`
`U.S.
`
`(Phase 2a)
`
`
`
`
`
`
`
`
`
`Indication
`
`Original/Licensor Region P1
`
`P2
`
`P3 NDA Filed Approved Launched
`
`Dev. code
`DE-128
`(InnFocus
`Europe
`
`
`
`
`
`MicroShunt)
`In August 2016, acquired InnFocus, developer of InnFocus MicroShunt. MicroShunt is the implant to lower and sustain intraocular pressure
`(IOP) out for the treatment of primary open-angle glaucoma by making aqueous humor drain out.
`
`-
`
`-
`
`Glaucoma
`
`Original
`
`U.S.
`
`
`
`(Phase 2/3)
`
`
`
`
`
`
`
`
`
`- 12 -
`
`
`
`
`
`
`
`
`
`Micro Labs Exhibit 1059-13
`
`
`
`
`
`
`
`
`
`Generic name
`
`Dev. name
`
`Indication
`
`Ciclosporin
`
`Cyclokat
`
`Severe keratitis