2015
`Year Ended March 31, 2015
`
`Contact:
`Corporate Communication Group
`Tel: 06-4802-9360 Fax: 06-6359-3827
`E-mail: ir@santen.co.jp
`Stock Code: 4536
`
`Micro Labs Exhibit 1058
`Micro Labs v. Santen Pharm. and Asahi Glass
`IPR2017-01434
`
`

`

`Financial highlights
`
`■Consolidated financial summary (J-GAAP)
`■Consolidated financial summary (IFRS, and Core base)
`■Consolidated balance sheets summary
`■Consolidated financial indexes
`■Exchange rates
`
`Consolidated information
`Consolidated statements of income and comprehensive income
`Statements of income and comprehensive income (IFRS)
`Operating result details
`■Major selling, general and administrative expenses
`■Major non-operating income and expenses (J-GAAP)
`
`Sales details
`
`■Sales by segment
`■Oversea sales by region
`■Oversea profit contribution (IFRS)
`■Sales of major prescription pharmaceuticals
`Consolidated balance sheets (J-GAAP)
`■Assets
`■Liabilities and net assets
`Statement of financial position (IFRS)
`■Assets
`■Equity and liabilities
`Consolidated statements of cash flows
`Other consolidated information
`■R&D expenditures
`■Capital expenditures
`■Depreciation and amortization
`■Number of employees
`
`Reference information
`Research & development
`■Pipeline of prescription pharmaceuticals (Clinical trials)
`■Santen S.A.S. pipeline of prescription pharmaceuticals (Clinical Stage)
`■Changes from February 3, 2015
`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
`■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
`2
`2
`4
`4
`5
`6
`6
`6
`7
`7
`7
`7
`8
`10
`10
`11
`12
`12
`13
`14
`16
`16
`16
`16
`16
`17
`17
`17
`18
`18
`19
`19
`19
`19
`20
`20
`20
`20
`21
`21
`22
`23
`
`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. Periods before the fiscal year ended March 31, 2014 are based on J-GAAP unless otherwise noted.
`Percent changes are 12-month, year-on-year comparisons.
`
`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
`
`May 12, 2015
`
`Micro Labs Exhibit 1058-2
`
`

`

`2014
`[12month]
`146,013
`28,835
`29,332
`18,922
`100
`43.6%
`
`(Millions of yen)
`2015 % Change
`2015/2014
`161,881
`10.9
`33,516
`16.2
`34,516
`17.7
`22,570
`19.3
`110
`－
`40.3%
`－
`
`－
`－
`－
`－
`－
`
`－
`－
`－
`－
`－
`
`2014
`－ 146,260
`29,878
`－
`19,718
`－
`11.1%
`－
`41.9%
`－
`30,403
`19,813
`11.2%
`48.0
`19.1
`
`－
`－
`－
`－
`－
`
`(Millions of yen)
`2016
`2015 % Change
`Forecast
`2015/2014
`161,831
`10.6
`186,500
`35,374
`18.4
`78,000
`24,032
`21.9
`52,500
`12.0%
`22.5%
`－
`37.8%
`18.9%
`－
`39,088
`40,300
`25,948
`26,900
`13.0%
`11.5%
`62.8
`65.1
`27.9
`－
`
`28.6
`31.0
`－
`30.8
`46.1
`
`－
`－
`－
`－
`－
`
`－
`－
`－
`－
`－
`
`■Consolidated financial summary (J-GAAP)
`2014*
`2013
`2011
`2012
`Year ended March 31
`Net sales
`110,812 114,416 119,066 148,663
`Operating income
`30,738
`26,733
`24,681
`27,414
`Ordinary income
`31,484
`27,780
`25,602
`27,924
`Net income
`21,333
`17,160
`16,520
`17,109
`Dividends per share (yen)
`90
`100
`100
`100
`Dividend payout
`36.0% 50.8% 51.1% 48.2%
`■Consolidated financial summary (IFRS, and Core base)
`Year ended March 31
`Revenue
`Operating profit
`Profit for the year
`ROE
`Dividend payout
`Core operating profit
`－
`－
`Profit for the year
`－
`－
`Core ROE
`－
`－
`Core dividends per share (yen)
`－
`－
`PER（times）
`－
`－
`■Consolidated balance sheets summary
`J-GAAP
`2014*
`2012
`2011
`2013
`184,801 198,801 199,640 231,105
`Total assets
`156,404 164,861 165,132 181,209
`Total equity
`188
`157
`133
`110
`Interest-bearing debts
`■Consolidated financial indexes
`
`Year ended March 31
`
`(Millions of yen)
`IFRS
`2015 % Change
`2015/2014
`304,200
`28.0
`211,779
`13.1
`37,161
`－
`
`2014
`237,640
`187,210
`153
`
`Year ended March 31
`
`IFRS
`J-GAAP
`2014
`2015 % Change
`2014
`2014*
`2013
`2012
`2011
`[12month]
`2015/2014
`58.18
`21.8
`47.78
`229.26
`207.29
`195.81
`196.96
`249.71
`EPS (yen)
`511.14
`13.0
`452.43
`2,234.70
`1,793.15 1,887.81 1,998.44 2,189.50
`BPS (yen) ※1
`0.2
`0.0
`0.0
`0.0
`0.0
`0.0
`0.0
`Debt equity ratio (times)
`－
`19.2
`30.1
`56.8
`20.0
`13.3
`17.9
`22.7
`22.1
`PER (times)
`3.4
`70.0
`2.0
`2.1
`1.9
`1.9
`2.2
`2.1
`PBR (times)
`12.0
`7.8
`11.1
`10.8
`14.5
`10.7
`10.0
`9.9
`ROE (%) ※1
`8.9
`-0.0
`8.9
`8.8
`12.1
`8.9
`8.3
`7.9
`ROA (%)
`69.6
`-11.7
`78.8
`79.3
`84.5
`82.8
`82.6
`78.2
`Equity ratio(%) ※1
`20,105
`-3.4
`20,806
`16,118
`18,203
`6,334
`21,172
`Free cash flows (millions of yen) ※2
`－
`31,081
`37.7
`22,565
`34,087
`30,601
`28,255
`29,812
`EBITDA (millions of yen) ※3
`－
`※1 BPS (net assets per share), ROE (return on equity) and equity ratios are based on the IFRS inputs of equity per share attributable to
`owners of the parent, net profit attributable to owners of parent and ratio of equity attributable to owners of the parent.
`※2 Free cash flows = (Cash flows from operating activities) - (Capital expenditures)
` 　 Not adjusting increase/decrease in trade receivables for fiscal years ending on holidays.
`※3 EBITDA = (Income before income taxes) + (Interest expense) + (Depreciation and amortization)
`■Exchange rates
`2011
`Year ended March 31
`85.57
`Exchange rate : US dollar
`113.45
`　　　　　　　 　: Euro
`12.94
`　　　　　　　 　: RMB
`* After reflecting unification of accounting period.
`
`2012
`79.03
`110.27
`12.34
`
`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
`
`(Yen)
`2016
`Forecast
`125.00
`135.00
`20.00
`
`2
`
`May 12, 2015
`
`Micro Labs Exhibit 1058-3
`
`

`

`
`■Consolidated Financial Summary (Graph)
`
`
`
`Operating income/Operating profit
`（Millions of yen）
`
`2012
`
`2013
`
`2014*
`
`2015
`
`2014
`**
`
`2015
`**
`
`Total equity (Millions of yen)
`
`Net sales/Revenue (Millions of yen)
`
`180,000
`
`Ordinary income
`160,000
`140,000
`
`120,000
`
`100,000
`
`80,000
`
`2012
`
`2013
`
`2014*
`
`2015
`
`2014
`**
`
`2015
`**
`
`Gain on insurance received
`Net income/Profit for the year
` (Millions of yen)
`
`30,000
`
`25,000
`
`20,000
`
`15,000
`
`10,000
`
`5,000
`
`0
`
`
`
`50,000
`
`40,000
`
`30,000
`
`20,000
`
`10,000
`
`0
`
`220,000
`
`200,000
`
`180,000
`
`160,000
`
`140,000
`
`120,000
`
`2012
`
`2013
`
`2014*
`
`2015
`
`2014
`**
`
`2015
`**
`
`2012
`
`2013
`
`2014*
`
`2014
`
`**
`
`**
`2015
`
`250.00
`
`EPS (yen)
`
`200.00
`【Non-consolidated】
`
`150.00
`
`100.00
`
`50.00
`
`Recurring income (millions of yen)
`0.00
`2012
`2013
`2014*
`#
`
`2014
`
`**
`
`2015
`
`**
`
`#
`ROE (%)
`
`14.0
`
`12.0
`
`10.0
`
`8.0
`
`6.0
`
`4.0
`
`2.0
`
`0.0
`
`2012
`
`2013
`
`2014*
`
`2014
`
`**
`
`**
`2015
`
`*After reflecting unification of accounting period. **IFRS
`
`40.0
`
`30.0
`
`20.0
`
`10.0
`
`0.0
`
`60.0%
`
`50.0%
`
`40.0%
`
`30.0%
`
`20.0%
`
`10.0%
`
`0.0%
`
`PER (times)
`
`2012
`
`2013
`
`2014*
`
`2014
`
`**
`
`**
`2015
`
`Divedend payout (%)
`
`2012
`
`2013
`
`2014*
`
`2014
`
`**
`
`**
`2015
`
`3
`
`May 12, 2015
`
`Micro Labs Exhibit 1058-4
`
`

`

`Consolidated information
`
`■Consolidated financial summary (J-GAAP)
`
`Year ended March 31
`
`2011
`
`2012
`
`2013
`
`2014*
`
`Net sales
`Cost of sales
`(Percentage of net sales)
`Gross profit
`(Percentage of net sales)
`Selling, general and administrative expenses
`(Percentage of net sales)
` R&D expenditures
`　(Percentage of net sales)
`Operating income
`(Percentage of net sales)
`Non-operating income
`Non-operating expenses
`Ordinary income
`(Percentage of net sales)
`Extraordinary gain
`Extraordinary loss
`Income before income taxes
`(Percentage of net sales)
`Income taxes - current
`Income taxes - deferred
`Income before minority interests
`Net income
`(Percentage of net sales)
`Income before minority interests
`Other comprehensive income
`Comprehensive income
`
`110,812
`34,436
`31.1%
`76,375
`68.9%
`45,636
`41.2%
`13,221
`11.9%
`30,738
`27.7%
`1,011
`265
`31,484
`28.4%
`15
`425
`31,074
`28.0%
`9,970
`-229
`21,333
`21,333
`19.3%
`21,333
`-1,537
`19,796
`
`114,416
`35,385
`30.9%
`79,031
`69.1%
`52,298
`45.7%
`17,225
`15.1%
`26,733
`23.4%
`1,119
`71
`27,780
`24.3%
`61
`51
`27,791
`24.3%
`9,912
`717
`17,160
`17,160
`15.0%
`17,160
`-194
`16,966
`
`119,066
`41,501
`34.9%
`77,564
`65.1%
`52,883
`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
`
`148,663
`58,104
`39.1%
`90,558
`60.9%
`63,144
`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
`
`2014
`[12month]
`146,013
`57,171
`39.2%
`88,842
`60.8%
`60,006
`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
`
` (Millions of yen)
`2015 % Change
`2015/2014
`
`161,881
`56,423
`34.9%
`105,458
`65.1%
`71,942
`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
`
`10.9
`-1.3
`
`18.7
`
`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
`
`　* After reflecting unification of accounting period.
`
`4
`
`May 12, 2015
`
`Micro Labs Exhibit 1058-5
`
`

`

`Consolidated information
`
`■IFRS (Full Base)
`
`Year ended March 31
`
`2011
`
`2012
`
`2013
`
`2014
`
` (Millions of yen)
`2015 % Change
`2015/2014
`
`－
`
`－
`
`－ 146,260
`－ -57,353
`39.2%
`－
`－ 88,907
`60.8%
`－
`－ -41,642
`28.5%
`－
`-190
`0.1%
`－
`－ -16,862
`11.5%
`－
`681
`-1,016
`－
`－ 29,878
`20.4%
`－
`－ 30,361
`20.8%
`－
`－ -10,643
`－ 19,718
`13.5%
`－
`11.1
`
`－
`
`10.6
`-1.7
`－
`18.6
`－
`17.4
`－
`
`－
`
`－
`3.7
`－
`6.3
`-54.9
`18.4
`－
`18.1
`－
`11.2
`21.9
`－
`
`161,831
`-56,373
`34.8%
`105,458
`65.2%
`-48,893
`30.2%
`-3,979
`2.5%
`-17,477
`10.8%
`723
`-458
`35,374
`21.9%
`35,863
`22.2%
`-11,831
`24,032
`14.9%
`12.0
`
`－
`－
`
`－
`
`－
`－
`
`－
`
`－
`
`－
`
`－
`
`－
`
`－
`
`－
`
`－
`
`－
`－
`
`－
`－
`
`－
`
`－
`－
`
`－
`
`－
`－
`
`－
`
`－
`－
`
`－
`
`－
`
`－
`
`－
`
`－
`
`－
`
`－
`
`－
`
`－
`－
`
`－
`－
`
`－
`
`－
`－
`
`－
`
`Revenue
`Cost of sales
`(Percentage of revenue)
`Gross profit
`(Percentage of revenue)
`Selling, general and administrative expenses
`(Percentage of revenue)
`Amortization on intangible assets associated with products
`(Percentage of revenue)
`Research and development expenses
`(Percentage of revenue)
`Other income
`Other expense
`Operating profit
`(Percentage of revenue)
`Profit before tax
`(Percentage of revenue)
`Income tax expenses
`Profit for the year
`(Percentage of revenue)
`
`ROE (%)
`
`　
`■IFRS (Core Base)
`
`Year ended March 31
`
`Revenue
`Cost of sales
`(Percentage of revenue)
`Gross profit
`(Percentage of revenue)
`Selling, general and administrative expenses
`(Percentage of revenue)
`Research and development expenses
`(Percentage of revenue)
`Operating profit
`(Percentage of revenue)
`Profit before tax
`(Percentage of revenue)
`Income tax expenses
`Profit for the year
`(Percentage of revenue)
`
`ROE (%)
`
`2011
`
`2012
`
`2013
`
`2014
`
` (Millions of yen)
`2015 % Change
`2015/2014
`
`－
`－
`
`－
`
`－
`－
`
`－
`
`－
`
`－
`
`－
`
`－
`－
`
`－
`－
`
`－
`
`－
`－
`
`－
`
`－
`－
`
`－
`
`－
`－
`
`－
`
`－
`
`－
`
`－
`
`－
`－
`
`－
`－
`
`－
`
`－
`－
`
`－
`
`－ 146,260
`－ -57,353
`39.2%
`－
`－ 88,907
`60.8%
`－
`－ -41,642
`28.5%
`－
`－ -16,862
`11.5%
`－
`－ 30,403
`20.8%
`－
`－ 30,403
`20.8%
`－
`－ -10,590
`－ 19,813
`13.6%
`－
`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
`
`10.6
`-1.7
`－
`18.6
`－
`17.4
`－
`3.7
`－
`28.6
`－
`28.6
`－
`24.1
`31.0
`－
`
`－
`
`5
`
`May 12, 2015
`
`Micro Labs Exhibit 1058-6
`
`

`

`■Major selling, general and administrative expenses
`2011
`2012
`2013
`Year ended March 31
`13,612
`14,933
`15,627
`4,490
`5,163
`5,233
`2,545
`1,952
`1,935
`1,500
`1,221
`1,116
`13,221
`17,225
`16,719
`
`Personnel expenses
`Sales promotion expenses
`Royalty expenses
`Advertising expenses
`R&D expenditures
`
`2014*
`17,822
`6,751
`2,547
`1,589
`19,040
`
`2014
`[12month]
`17,092
`6,257
`2,515
`1,439
`18,235
`
` (Millions of yen)
`2015
`% Change
`[IFRS]
`2015/2014
`18,381
`7.5
`7,267
`16.1
`2,916
`15.9
`2,041
`41.8
`17,477
`-4.2
`
`■Major non-operating income and expenses　(J-GAAP)
`2011
`2012
`2013
`2014*
`Year ended March 31
`521
`528
`522
`601
`136
`143
`157
`147
`36
`22
`6
`5
`
`Interest and dividend income
`Gain on insurance received
`Interest expense
`
`2014
`[12month]
`598
`147
`9
`
` (Millions of yen)
`2015 % Change
`2015/2014
`620
`3.7
`144
`-2.0
`91
`911.1
`
`* After reflecting unification of accounting period.
`
`6
`
`May 12, 2015
`
`Micro Labs Exhibit 1058-7
`
`

`

`■Sales by segment
`Year ended March 31
`
`Pharmaceuticals
` Prescription pharmaceuticals
` Ophthalmic
` Anti-rheumatic drugs
` Other prescription pharmaceuticals
` OTC pharmaceuticals
`Others
` Medical devices
` Others
`Total net sales
`[Domestic]
`Year ended March 31
`Pharmaceuticals
` Prescription pharmaceuticals
` Ophthalmic
` Anti-rheumatic drugs
` Other prescription pharmaceuticals
` OTC pharmaceuticals
`Others
` Medical devices
` Others
`Total net sales
`(Percentage of total net sales)
`[Overseas]
`Year ended March 31
`
`Pharmaceuticals
` Prescription pharmaceuticals
` Ophthalmic
` Anti-rheumatic drugs
` Other prescription pharmaceuticals
` OTC pharmaceuticals
`Others
` Medical devices
` Others
`Total net sales
`(Percentage of total net sales)
`■Oversea sales by region
`
`2011
`Year ended March 31
`3,069
`U.S.
`8,516
`Europe
`6,667
`Asia
`8
`Others
`18,262
`Total oversea sales
`■Oversea profit contribution (IFRS)
`
`－
`U.S.
`－
`Europe
`－
`Asia
`－
`Others
`－
`Total oversea sales
`* After reflecting unification of accounting period.
`
`2011
`108,575
`103,852
`90,797
`9,833
`3,221
`4,723
`2,236
`2,224
`11
`110,812
`
`2012
`111,846
`107,249
`93,620
`9,987
`3,641
`4,597
`2,570
`2,558
`11
`114,416
`
`2011
`91,047
`86,332
`75,585
`9,727
`1,020
`4,715
`1,501
`1,490
`11
`92,549
`83.5%
`
`2011
`17,527
`17,519
`15,211
`106
`2,200
`8
`734
`734
`－
`18,262
`16.5%
`
`2012
`93,449
`88,862
`77,753
`9,883
`1,225
`4,587
`1,924
`1,912
`11
`95,374
`83.4%
`
`2012
`18,396
`18,386
`15,866
`103
`2,416
`10
`645
`645
`－
`19,042
`16.6%
`
`2013
`116,810
`110,336
`98,981
`9,874
`1,480
`6,474
`2,255
`2,245
`10
`119,066
`
`2013
`98,521
`92,062
`81,125
`9,810
`1,126
`6,458
`2,189
`2,178
`10
`100,711
`84.6%
`
`2013
`18,288
`18,273
`17,855
`63
`354
`15
`66
`66
`－
`18,354
`15.4%
`
`2014*
`145,712
`139,257
`127,395
`10,251
`1,610
`6,455
`2,950
`2,678
`272
`148,663
`
`2014*
`119,215
`112,798
`101,779
`10,162
`856
`6,417
`2,897
`2,625
`272
`122,113
`82.1%
`
`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*
`26,497
`26,459
`25,616
`88
`754
`37
`52
`52
`－
`26,550
`17.9%
`
`2014
`[12month]
`23,878
`23,843
`23,010
`88
`743
`35
`52
`52
`－
`23,931
`16.4%
`
`2014
`1,016
`11,466
`11,700
`7
`24,188
`
`2014
`-1,124
`-74
`1,311
`－
`113
`
`J-GAAP
`2012
`3,450
`8,880
`6,705
`5
`19,042
`
`2013
`582
`9,202
`8,559
`10
`18,354
`
`2014*
`1,073
`12,294
`13,173
`8
`26,550
`
`－
`－
`－
`－
`－
`
`－
`－
`－
`－
`－
`
`－
`－
`－
`－
`－
`
`7
`
` (Millions of yen)
`2015
`% Change
`[IFRS]
`2015/2014
`159,261
`11.1
`152,556
`11.5
`136,059
`8.8
`9,629
`-6.1
`6,868
`330.6
`6,705
`4.1
`-12.6
`2,569
`2,327
`-13.1
`242
`-7.4
`161,831
`10.7
` (Millions of yen)
`2015
`% Change
`[IFRS]
`2015/2014
`122,310
`2.6
`115,672
`2.6
`105,345
`3.5
`9,568
`-5.9
`759
`-9.6
`6,638
`3.7
`2,526
`-12.5
`2,283
`-13.0
`-7.4
`242
`124,835
`2.3
`77.1%
` (Millions of yen)
`2015
`% Change
`[IFRS]
`2015/2014
`36,952
`53.1
`36,884
`53.1
`32.1
`2,015
`61
`-31.2
`6,109
`708.8
`67
`85.5
`43
`-17.9
`43
`-17.9
`－
`－
`36,995
`53.0
`22.9%
` (Millions of yen)
`IFRS
`2015 % Change
`2015/2014
`6,169
`507.4
`14,156
`23.5
`16,668
`42.5
`2
`-63.2
`36,995
`53.0
` (Millions of yen)
`
`2015 % Change
`2015/2014
`-1,259
`－
`3,592
`－
`3,780
`188.3
`－
`－
`6,113
`－
`
`May 12, 2015
`
`Micro Labs Exhibit 1058-8
`
`

`

`■Sales of major prescription pharmaceuticals
`Therapeutic category
`
`Generic name/formulation
`
`Bacterial conjunctivitis
`
`levofloxacin/ophthalmic solution
`
`ofloxacin/ophthalmic solution
`
`tafluprost-timolol maleate/
`combination ophthalmic solution
`
`tafluprost/opthalmic solution
`
`dorzolamide hydrochloride-timolol maleate/
`combination ophthalmic solution
`
`Brand name
`
`Cravit
`
`Tarivid
`
`Tapcom
`
`Tapros
`
`Cosopt
`
`Glaucoma
`
`timolol maleate/ophthalmic solution
`
`Timoptol
`
`timolol maleate/
` long-acting ophthalmic solution
`
`Timoptol XE
`
`dorzolamide hydrochloride/ophthalmic solution
`
`bunazosin hydrochloride/opthalmic solution
`isopropyl unoprostone/opthalmic solution
`epinastine hydrochloride/ophthalmic solution
`levocabastine hydrochloride/ophthalmic solution
`
`sodium hyaluronate/ ophthalmic solution
`
`diquafosol sodium
`
`Trusopt
`
`Detantol
`Rescula
`Alesion
`Livostin
`
`Hyalein
`
`Diquas
`
`Allergy
`
`Corneal disease
`
`Inflammation
`
`fluorometholone/ophthalmic solution
`
`Flumetholon
`
`Senile cataract
`
`pirenoxine/ophthalmic solution
`
`Adjuvant for ophthalmic operations
`Intravitreal VEGF inhibitor
`
`sodium hyaluronate/ adjuvant for ophthalmic operations
`aflibercept solution for intravitreal injection
`
`Kary Uni
`
`Opegan Hi
`Eylea
`
`Region
`Total
`Japan
`Asia
`Europe
`Total
`Japan
`Asia
`Total
`Japan
`Europe
`Total
`Japan
`Asia
`Europe
`Total
`Japan
`Asia
`Europe
`Total
`Japan
`Asia
`Europe
`Total
`Japan
`Asia
`Europe
`Total
`Japan
`Asia
`Europe
`Japan
`Japan
`Japan
`Japan
`Total
`Japan
`Asia
`Total
`Japan
`Asia
`Total
`Japan
`Asia
`Total
`Japan
`Asia
`Japan
`Japan
`
`8
`
`May 12, 2015
`
`Micro Labs Exhibit 1058-9
`
`

`

`
`Year ended March 31
`
`2011
`2012
`2014*
`2013
`13,865
`13,266
`14,210
`11,856
`11,484
`10,816
`8,175
`8,499
`1,421
`1,552
`4,670
`2,358
`913
`894
`1,364
`1,010
`2,420
`1,932
`2,040
`1,831
`1,528
`1,287
`955
`1,086
`892
`645
`1,085
`745
`－
`－
`－
`－
`－
`－
`－
`－
`－
`－
`－
`－
`8,189
`9,407
`12,731
`10,308
`6,578
`7,180
`8,957
`7,605
`55
`172
`553
`268
`1,556
`2,055
`3,221
`2,435
`2,935
`6,272
`11,846
`9,007
`2,935
`6,272
`11,846
`9,007
`－
`－
`－
`－
`－
`－
`－
`－
`2,153
`1,702
`1,185
`1,367
`2,153
`1,702
`1,185
`1,367
`－
`－
`－
`－
`－
`－
`－
`－
`2,892
`2,404
`1,931
`2,085
`2,892
`2,404
`1,931
`2,085
`－
`－
`－
`－
`－
`－
`－
`－
`－
`－
`－
`－
`－
`－
`－
`－
`－
`－
`－
`－
`－
`－
`－
`－
`2,065
`1,968
`1,549
`1,735
`2,777
`2,472
`2,147
`2,243
`2,103
`－
`－
`－
`3,801
`3,347
`2,535
`4,036
`21,257
`22,217
`21,823
`21,160
`18,762
`19,697
`18,179
`18,274
`2,495
`2,520
`3,645
`2,886
`746
`2,846
`7,938
`5,563
`746
`2,846
`7,831
`5,563
`106
`－
`－
`－
`4,753
`4,073
`3,973
`4,448
`4,117
`3,471
`3,075
`3,736
`636
`602
`898
`712
`3,729
`3,690
`4,060
`3,766
`3,281
`3,176
`3,162
`3,107
`448
`514
`898
`659
`3,226
`3,018
`2,868
`2,842
`18,757
`3,183
`－
`－
`*After reflecting unification of accounting period.
`
`2014
`[12month]
`13,584
`8,175
`4,139
`1,270
`1,924
`955
`969
`－
`－
`－
`12,516
`8,957
`520
`3,040
`11,846
`11,846
`－
`－
`1,185
`1,185
`－
`－
`1,931
`1,931
`－
`－
`－
`－
`－
`－
`1,549
`2,147
`2,103
`2,535
`21,416
`18,179
`3,237
`7,938
`7,831
`107
`3,899
`3,075
`823
`3,978
`3,162
`816
`2,868
`18,757
`
`2015 % Change
`2015/2014
`13,399
`-1.4
`6,498
`-20.5
`5,423
`31.0
`1,478
`16.4
`1,910
`-0.7
`762
`-20.2
`1,147
`18.5
`381
`－
`342
`－
`39
`－
`12,330
`-1.5
`8,329
`-7.0
`817
`57.1
`3,185
`4.8
`12,478
`5.3
`10,689
`-9.8
`892
`－
`897
`－
`1,267
`7.0
`1,216
`2.7
`29
`－
`22
`－
`1,984
`2.7
`1,918
`-0.7
`27
`－
`39
`－
`1,853
`－
`1,545
`－
`55
`－
`252
`－
`1,228
`-20.7
`1,935
`-9.9
`6,698
`218.5
`2,263
`-10.7
`19,611
`-8.4
`15,316
`-15.7
`4,295
`32.7
`7,895
`-0.5
`7,419
`-5.3
`476
`344.8
`3,811
`-2.3
`2,844
`-7.5
`967
`17.5
`3,909
`-1.7
`2,908
`-8.0
`1,001
`22.6
`2,574
`-10.2
`24,886
`32.7
`
`2016
`Forecast
`14,331
`6,461
`6,443
`1,428
`1,866
`673
`1,193
`1,924
`1,367
`557
`16,413
`9,186
`1,152
`6,075
`19,703
`
`10,955
`
`2,596
`
`6,152
`
`2,299
`
`1,213
`
`154
`
`932
`
`2,009
`
`1,784
`
`92
`
`133
`
`4,237
`1,891
`625
`1,721
`1,197
`1,871
`6,407
`2,146
`20,724
`15,033
`5,691
`11,178
`9,785
`1,393
`3,970
`2,796
`1,175
`4,388
`3,041
`1,346
`2,658
`33,859
`
` (Millions of yen)
`
`Brand name
`
`Cravit
`
`Tarivid
`
`Tapcom
`
`Tapros
`
`Cosopt
`
`Timoptol
`
`Timoptol XE
`
`Trusopt
`
`Detantol
`Rescula
`Alesion
`Livostin
`
`Hyalein
`
`Diquas
`
`Flumetholon
`
`Kary Uni
`
`Opegan Hi
`Eylea
`
`9
`
`May 12, 2015
`
`Micro Labs Exhibit 1058-10
`
`

`

`2011
`
`2012
`
`2013
`
`2014*
`
`2015
`
` (Millions of yen)
`
`■Assets
`
`Year ended March 31
`
`Current assets
`　Cash and deposits
`　Notes and accounts receivable-trade
`　Marketable securities
`　Merchandise and finished goods
`　Work in process
`　Raw materials and supplies
`　Deferred tax assets
`　Other current assets
`　Allowance for doubtful receivables
`
`Fixed assets
`　Tangible assets
`　　Buildings and structures
`　　Machinery, equipment and vehicles
`　　Land
` Lease assets
`　　Construction in progress
`　　Other tangibles
`
`　Intangible assets
`　　Goodwill
`　　In-process research and development
`　　Software
` Other intangibles
`
`%
`137,668 74.5
`65,558
`38,980
`13,332
`11,784
`449
`2,469
`1,986
`3,106
`-1
`
`47,133 25.5
`24,956 13.5
`13,450
`1,632
`8,216
`186
`186
`1,283
`
`0.5
`
`991
`－
`－
`952
`39
`
`%
`140,288 70.6
`66,235
`37,923
`12,739
`14,672
`600
`2,677
`1,921
`3,521
`-1
`
`58,513 29.4
`25,523 12.8
`12,806
`1,581
`8,213
`166
`1,365
`1,390
`
`6.5
`
`12,877
`5,801
`5,941
`831
`301
`
`%
`132,582 66.4
`50,884
`43,840
`11,007
`16,703
`624
`3,620
`1,880
`4,022
`-1
`
`67,057 33.6
`27,420 13.7
`13,427
`1,584
`8,240
`158
`2,454
`1,554
`
`7.1
`
`14,123
`5,936
`6,767
`1,150
`269
`
`%
`156,006 67.5
`63,509
`52,086
`13,111
`16,223
`390
`3,417
`2,346
`4,925
`-3
`
`75,099 32.5
`27,628 12.0
`14,146
`2,210
`8,266
`155
`816
`2,032
`
`7.2
`
`16,585
`6,297
`8,357
`1,826
`102
`
`%
`154,612 52.2
`65,944
`59,611
`－
`16,035
`585
`4,021
`3,165
`5,252
`-3
`
`141,744 47.8
`29,103
`9.8
`13,265
`2,441
`8,072
`146
`3,006
`2,170
`
`73,272 24.7
`4,970
`7,688
`1,918
`58,694
`
`39,368 13.3
`33,349
`2,115
`3,903
`
`　Investments and other assets
`　　Investment securities
`　　Deferred tax assets
`　　Other assets
`
`21,185 11.5
`12,141
`7,538
`1,505
`
`20,112 10.1
`12,411
`6,500
`1,200
`
`25,513 12.8
`18,173
`4,460
`2,879
`
`30,885 13.4
`21,739
`5,488
`3,657
`
`Deferred assets
`
`Total assets
`
`－ －
`
`－ －
`
`－ －
`
`－ －
`
`－ －
`
`184,801 100.0
`
`198,801 100.0
`
`199,640 100.0
`
`231,105 100.0
`
`296,357 100.0
`
`* After reflecting unification of accounting perio
`
`10
`
`May 12, 2015
`
`Micro Labs Exhibit 1058-11
`
`

`

`■Liabilities and net assets
`
`Year ended March 31
`
`Current liabilities
`　Trade accounts payable
` Short-term debt
`　Other payables
`　Income taxes payable
` Reserve for bonuses
`　Provision for sales returns
`　Other current liabilities
`Non-current liabilities
` Lease Obligations
`　Deferred tax liabilities
`　Retirement and severance benefits
`　Retirement and severance benefits
` for directors and auditors
`　Net defined benefit liability
`　Provision for business structure improvement
` Asset retirement obligations
` Other liabilities
`Total liabilities
`
`Shareholders' equity
`　Common stock
`　Capital surplus
`　Retained earnings
`　Treasury stock, at cost
`Accumulated other comprehensive income
`　Unrealized gains on securities, net of taxes
`　Foreign currency translation adjustments
` Remeasurements of defined benefit plans
`Stock subscription rights
`
`Total net assets
`Total liabilities and
` net assets
`
` (Millions of yen)
`
`2011
`
`2012
`
`2013
`
`2014*
`
`2015
`
`%
`13.0
`
`2.3
`
`%
`13.8
`
`3.3
`
`%
`13.5
`
`3.8
`
`%
`16.9
`
`4.7
`
`%
`19.0
`
`12.0
`
`56,162
`14,329
`11,767
`13,268
`6,823
`3,840
`186
`5,945
`35,475
`46
`2,723
`－
`
`39,093
`14,270
`－
`9,695
`8,169
`3,573
`135
`3,249
`10,802
`59
`2,796
`－
`
`27,011
`9,266
`－
`9,868
`3,038
`3,085
`104
`1,647
`7,496
`87
`2,269
`3,664
`
`27,425
`8,074
`－
`9,009
`5,282
`2,943
`81
`2,033
`6,514
`115
`1,996
`3,459
`
`24,104
`6,031
`－
`8,444
`4,631
`2,712
`87
`2,198
`4,292
`152
`20
`3,266
`
`453
`－
`－
`160
`238
`28,397 15.4
`
`222
`－
`－
`161
`559
`33,940 17.1
`
`248
`－
`－
`160
`1,066
`34,507 17.3
`
`－
`5,400
`802
`221
`1,521
`49,896 21.6
`
`－
`5,457
`766
`223
`26,257
`91,638 30.9
`
`64.1
`75.9 190,015
`83.1 175,328
`85.9 165,855
`87.7 170,770
`162,159
`2.5
`3.1
`7,383
`3.5
`7,264
`3.4
`7,080
`3.6
`6,694
`6,614
`2.7
`3.4
`8,077
`3.9
`7,958
`4.0
`7,775
`4.3
`8,049
`7,968
`147,578 79.9
`156,030 78.5
`151,001 75.6
`160,115 69.3
`174,573 58.9
`-1
`-0.0
`-4
`0.0
`-2
`-0.0
`-9
`-0.0
`-18
`-0.0
`-6,061
`-3.3
`-6,255
`-3.1
`-1,047
`-0.5
`5,481
`2.4
`14,151
`4.8
`-443
`-0.2
`51
`0.0
`1,920
`1.0
`4,035
`1.7
`12,048
`4.1
`-5,618
`-3.0
`-6,306
`-3.2
`-2,967
`-1.5
`2,574
`1.1
`2,845
`1.0
`－ － -1,128
`-0.5
`-743
`-0.3
`－ －
`－ －
`305
`0.2
`347
`0.2
`324
`0.2
`399
`0.2
`552
`0.2
`
`156,404
`
`84.6 164,861
`
`82.9 165,132
`
`82.7 181,209
`
`78.4 204,719
`
`69.1
`
`184,801 100.0 198,801 100.0 199,640 100.0 231,105 100.0 296,357 100.0
`
`* After reflecting unification of accounting period.
`
`11
`
`May 12, 2015
`
`Micro Labs Exhibit 1058-12
`
`

`

`■Assets
`
`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
`Sub total
`Assets held for sale
`Total current assets
`
`2014
`
`%
`
` (Millions of yen)
`
`2015
`
`%
`
`27,175
`26,610
`23,334
`5,215
`2,065
`84,399
`
`19,461
`53,986
`4,587
`2,356
`72,397
`152,787
`454
`153,241
`
`11.4
`11.2
`9.8
`2.2
`0.9
`35.5
`
`8.2
`22.7
`1.9
`1.0
`30.5
`
`0.2
`64.5
`
`29,104
`84,433
`34,725
`2,978
`2,288
`153,528
`
`20,133
`61,701
`187
`2,728
`65,923
`150,672
`－
`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
`
`Total assets
`
`237,640
`
`100.0
`
`304,200
`
`100.0
`
`12
`
`May 12, 2015
`
`Micro Labs Exhibit 1058-13
`
`

`

`■Equity and liabilities
`
`Equity
`Equity attributable to owners of the parent
`Share capital
`Capital surplus
`Treasury shares
`Retained earnings
`Other components of equity
`Total equity attributable to owners of the parent
`
`Total equity
`
`Liabilities
`Non-current liabilities
`Financial liabilities
`Retirement 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
`
`2014
`
`%
`
` (Millions of yen)
`
`2015
`
`%
`
`7,264
`7,959
`-9
`162,727
`9,269
`187,210
`
`187,210
`
`102
`5,401
`1,467
`2,795
`1,479
`11,244
`
`19,072
`4,880
`8,081
`996
`6,157
`39,186
`
`50,430
`
`3.1
`3.4
`-0.0
`68.5
`3.9
`78.8
`
`78.8
`
`0.0
`2.3
`0.6
`1.2
`0.6
`4.7
`
`8.0
`2.1
`3.4
`0.4
`2.6
`16.5
`
`21.2
`
`7,383
`8,077
`-18
`178,840
`17,497
`211,779
`
`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
`
`2.4
`2.7
`-0.0
`58.8
`5.8
`69.6
`
`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
`
`Total equity and liabilities
`
`237,640
`
`100.0
`
`304,200
`
`100.0
`
`13
`
`May 12, 2015
`
`Micro Labs Exhibit 1058-14
`
`

`

`Year ended March 31
`
`Ⅰ. Cash flows from operating activities:
`Income before income taxes
`Depreciation and amortization
`Amortization of goodwill
`Gain on sales of investment securities
`Loss on impairment of fixed assets
`Business structure improvement expenses
`Increase/decrease in retirement and
`severance benefits
`Increase (decrease) in Net defined benefit liability
`Interest and dividend income
`Interest expense
`Increase/decrease in trade receivables
`Increase/decrease in inventories
`Increase/decrease in trade accounts payable
`Other, net
`　Subtotal
`Interest and dividend income received
`Interest expense paid
`Income taxes paid
`　Net cash provided by operating activities
`
`Ⅱ. Cash flows from investing activities:
`Increase in fixed deposits
`Decrease in fixed deposits
`Payments for acquisition of marketable securities
`Proceeds from sales and redemption of securities
`Payments for acquisition of fixed assets
`Proceeds from sale of fixed assets
`Purchase of investment securities
`Proceeds from sale of investment securities
`Payments for loans
`Proceeds from loans
`Other, net
`　Net cash(used in) provided by investing activities
`
`Ⅲ. Cash flows from financing activities:
`Purchase of treasury stock
`Dividends paid
`Other, net
`　Net cash provided by financing activities
`Ⅳ. Effect of exchange rate changes on cash
` and cash equivalents
`Ⅴ. Net increase/decrease in cash and cash equivalents
`Ⅵ. Cash and cash equivalents at beginning of year
`Ⅶ. Cash and cash equivalents at end of year
`
`* After reflecting unification of accounting period.
`
`2011
`
`31,074
`2,976
`－
`－
`－
`－
`
`359
`
`－
`-521
`36
`-3,892
`-1,299
`521
`-11
`29,243
`513
`-36
`-11,951
`17,769
`
`-4,384
`3,519
`-1,488
`403
`-1,650
`188
`-4,296
`20
`-0
`－
`13
`-7,676
`
`-25
`-6,808
`5,263
`-1,570
`
`-388
`
`8,133
`64,348
`72,482
`
`2012
`
`27,791
`2,787
`162
`-57
`19
`－
`
`178
`
`－
`-528
`22
`1,037
`-3,294
`2,033
`66
`30,219
`549
`-16
`-9,268
`21,483
`
`-165
`2,781
`-1,617
`4,850
`-3,280
`6
`-2,420
`377
`-6
`7
`-10,805
`-10,272
`
`-2
`-8,705
`148
`-8,559
`
`-98
`
`2,553
`72,482
`75,035
`
` (Millions of yen)
`2013
`2014*
`
`25,591
`2,656
`634
`－
`－
`－
`
`186
`
`－
`-522
`6
`-5,559
`-2,588
`1,170
`-1,790
`19,785
`532
`-3
`-10,372
`9,942
`
`-504
`630
`-301
`4,048
`-3,608
`37
`-4,882
`1
`－
`2
`-17
`-4,595
`
`-13,764
`-8,468
`675
`-21,557
`
`972
`
`-15,238
`75,035
`59,797
`
`26,893
`2,914
`1,012
`-473
`94
`1,380
`
`－
`
`313
`-601
`5
`-7,672
`1,650
`4,927
`1,969
`32,412
`614
`-2
`-7,066
`25,958
`
`-130
`111
`-604
`2,407
`-4,786
`11
`-4,220
`524
`-2
`－
`-6
`-6,694
`
`-6
`-8,247
`300
`-7,953
`
`1,289
`
`12,599
`59,797
`72,396
`
`14
`
`May 12, 2015
`
`Micro Labs Exhibit 1058-15
`
`

`

`Year ended March 31
`
`Ⅰ. Cash flows from operating activities:
`Profit for the year
`Depreciation and amortization
`Impairment losses
`Finance income and expense
`Income tax expenses
`Decrease (increase) in trade and other receivables
`Decrease (increase) in inventories
`Decrease (increase) in trade and other payables
`Decrease (increase) in provisions and retirement benefit liabilities
`Other
` Sub total
`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 fixed deposits
`Proceeds from withdrawal of fixed deposits
`Purchase of investments
`Proceeds from sale and redemption of investments
`Purchase of property, plant and equipment
`Proceeds from sales of property, plant and equipment
`Purchase of intangible assets
`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
`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 beginning of year
`Ⅵ. Effect of exchange rate changes on cash and cash equivalents
`Ⅶ. Cash and cash equivalents at end of year
`
` (Millions of yen)
`
`2015
`
`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
`
`2014
`
`19,718
`2,841
`216
`-759
`10,643
`-8,128
`1,411
`5,242
`346
`1,883
`33,413
`104
`518
`-9
`-7,340
`26,686
`
`-111
`92
`-4,825
`2,933
`-3,461
`2
`-2,418
`-59
`-7,847
`
`－
`－
`－
`-29
`-8,247
`322
`-7,954
`10,885
`60,237
`1,275
`72,397
`
`15
`
`May 12, 2015
`
`Micro Labs Exhibit 1058-16
`
`

`

`■R&D expenditures
`Year ended March 31
`
`Consolidated
`(Percentage of net sales)
`
`■Capital expenditures
`Year ended March 31
`
`Consolidated
`
`2011
`
`13,221
`11.9%
`
`2012
`
`17,225
`15.1%
`
`2013
`
`16,719
`14.0%
`
`2014*
`
`19,040
`12.8%
`
`2011
`
`1,709
`
`2012
`
`3,492
`
`2013
`
`4,202
`
`2014*
`
`3,155
`
`Note: Includes investment in facilities spent on a lease contract basis.
`
`■Depreciation and amortization
`Year ended March 31
`
`Manufacturing cost
`Selling, general and administrative expenses
`R&D expenses
`Consolidated
`
`2011
`
`1,532
`512
`762
`2,808
`
`2012
`
`1,400
`553
`764
`2,717
`
`2013
`
`1,211
`533
`785
`2,530
`
`2014*
`
`1,330
`648
`634
`2,612
`
`（Millions of yen）
`2015
`2016
`【IFRS】
`Forecast
`17,477
`22,900
`10.8%
`12.3%
`
` (Millions of yen)
`2015
`2016
`【IFRS】
`Forecast
`5,383
`7,650
`
` (Millions of yen)
`2015
`2016
`【IFRS】
`Forecast
`1,446
`1,440
`4,843
`7,080
`668
`800
`6,958
`9,320
`
`■Number of employees
`Year ended March 31
`
`Consolidated
` Sales division
` Production division
` R&D division
` Corporate or back-office division
`
`* After reflecting unification of accounting period.
`
`2011
`2,867
`1,108
`847
`574
`338
`
`2012
`3,053
`1,268
`860
`624
`301
`
`2013
`3,050
`1,322
`820
`599
`309
`
`2014*
`3,072
`1,360
`785
`604
`323
`
`2015
`3,230
`1,510
`762
`605
`353
`
`16
`
`May 12, 2015
`
`Micro Labs Exhibit 1058-17
`
`

`

`
`
`Reference information Reference information
`
`■Pipeline of prescription pharmaceuticals (Clinical Stage)
`
`Original/Licensor
`Indication
`Dev. code
`Generic name
`Region
`Co-development
`Glaucoma/
`Asia
`DE-085
`Tafluprost
`Jan-11
`with Asahi Glass
`Ocular hypertension
`China
`A prostaglandin F2α derivative for the treatment of glaucoma and ocular hypertension. Since December, 2008, launched in Japan, Europe, and the U.S.
`In Asia, launched in Hong Kong, Korea, Indonesia, and Singapore, etc. NDA filed in China in January, 2011.
`
`P1
`
`P2
`
`P3
`
`NDA Filed Approved Launched
`Mar-10
`
`Generic name
`
`Dev. code
`
`Indication
`
`Original/Licensor
`
`P1
`
`P2
`
`P3
`
`Diquafosol sodium DE-089
`
`Dry eye
`
` Merck Sharp &
`Dohme Corp. (U.S.)
`
`Region
`Korea
`Jan-12
`China
`Jan-13
`Asia
`A dry eye treatment drug which stimulates secretion of mucin and aqueous components from the corneal epithelium. Its mechanism of action is different
`from other existing treatments. Launched in December, 2010 in Japan and in October, 2013 in Korea. NDA filed in China in January, 2012.
`
`NDA Filed Approved Launched
`Oct-13
`
`Generic name
`Lomerizine HCl
`
`Dev. code
`DE-090
`
`Indication
`
`Glaucoma
`
`Original/Licensor
`
`Region
`
`P1
`
`P2
`
`P3
`
`NDA Filed Approved Launched
`
`MSD K.K.
`
`Japan
`
`A new type of glaucoma treatment which inhibits the progression of visual field defects. It is the only calcium antagonist being development as an oral
`glaucoma treatment. Compared to NMDA receptor antagonists, it has excellent safety profile with mild systemic advers