throbber
Year Ended March 31, 2017
`
`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

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket