IPR Page 1/13
`
`Santen/Asahi Glass Exhibit 2030
`Micro Labs v. Santen Pharm. and Asahi Glass
`IPR2017-01434
`
`

`

`3. Consolidated forecasts of results for the year ending March 31I 2018
`(Core basis *1)
`
`Revenue
`Core operating profit
`Core net profit for the year
`Core net profit for the year attributable to owners of the company
`
`Core earnings per share (yen)
`
`Year to
`March 2018
`
`% change
`
`(IFRS)
`
`Year to
`March 2018
`
`% change
`
`Revenue
`Operating profit
`Profit before tax
`
`Basic earnings per share (yen)
`
`Net profit for the year
`Net profit for the year attributable to owners of the company
`
`Note 1:The consolidated forecasts of results for the year ending March 31, 2018, which were released on May 10, 2017, are changed.
`2:FY16 results are corrected retroactively from prior announced results upon the finalization of the purchase price allocation (PPA)
`relating to the acquisition of lnnFocus. There was no resulting impact on operating profit. However, this PPA finalization resulted in a
`positive impact on FY16 core net profit of 437 million yen and in a negative impact on FY16 net profit of 1,330 million yen.
`
`*Others
`
`(1) Changes in significant subsidiaries during the term
`(changes in designated subsidiaries resulting in adjustment to the scope of consolidation): No
`Note: Santen Ventures, Inc. has newly become a consolidated subsidiary.
`
`(2) Changes in accounting policies and accounting estimates
`[ i ] Changes in the accounting policies required by IFRS: No
`[ii] Other changes: No
`[iii ] Changes in accounting estimates: No
`
`(3) Number of shares outstanding (common stock):
`[ i ] Number of shares outstanding at the end of period (including treasury shares)
`December 31,2017 : 406,500,015
`March 31,2017
`: 406,173,015
`
`[ ii ] Number of treasury shares at the end of period
`December 31, 2017 :
`7,166
`March 31, 2017
`:
`6,646
`
`[ iii ] Average number of outstanding shares (during the fiscal year ended December 31)
`Third quarter ended December 31, 2017: 406,304,134
`Third quarter ended December 31, 2016: 411,719,990
`
`(Information regarding the implementation of audit procedures)
`This financial report is exempt from audit.
`
`(Information regarding presentation currency)
`All financial information presented in Japanese yen has been rounded to the nearest million, except when otherwise indicated.
`
`(Caution)
`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, delays in new products launch, currency exchange rate, legislative and regulatory developments.
`
`*1(Core basis)
`Core results are non-IFRS measures that remove non-core items including amortization on intangible assets associated with products, other
`income and expenses, finance income and expenses, and temporary expenses of selling, general and administrative expenses in order to
`provide greater transparency on underlying business performance.
`
`_2_
`
`IPR Page 2/13
`
`IPR Page 2/13
`
`

`

`Quarterly consolidated statements of income and
`
`comprehensive income
`
`IFRS basis
`
`Revenue
`Cost of sales
`Gross profit
`
`Selling, general and administrative expenses
`Research and development expenses
`Amortization on intangible assets associated with products
`Other income
`
`Other expenses
`Operating profit
`
`Finance income
`
`Finance expenses
`Profit before tax
`Income tax expenses
`Net profit for the period
`
`Other comprehensive income
`Items that will not be reclassified subsequently to profit of loss
`Remeasurements of defined benefit plans
`
`Net gain on financial assets measured at fair value
`through other comprehensive income
`Items that may be reclassified subsequently to profit or loss
`Foreign currency translation adjustments
`Other comprehensive income
`Total comprehensive income
`
`Profit attributable to
`
`Owners of the company
`Non-controlling interests
`Net profit for the period
`Total comprehensive income attributable to
`Owners of the company
`Non-controlling interests
`Total comprehensive income
`
`Earnings per share
`Basic earnings per share (yen)
`Diluted earnings per share (yen)
`
`Core basis
`
`Revenue
`Core operating profit
`Core net profit for the period
`Basic core earnings per share (yen)
`Diluted core earnings per share (yen)
`
`Core profit attributable to
`Owners of the company
`Non-controlling interests
`Core net profit for the period
`
`IPR Page 3/13
`
`Nine months ended
`December 31, 2016
`
`(JPY millions)
`Nine months ended
`December 31, 2017
`
`150,667
`(57,633)
`93,034
`
`(44,583)
`(15,930)
`(4,761)
`294
`
`(566)
`27,488
`
`874
`
`(4,443)
`23,919
`(6,756)
`17,163
`
`—
`
`(5 256)
`’
`
`5,674
`418
`17,581
`
`17,164
`(1)
`17,163
`
`17,558
`23
`17,581
`
`41.69
`41.53
`
`
`
`(JPY millions)
`
`Nine months ended
`December 31, 2016
`
`Nine months ended
`December 31, 2017
`
`150,667
`33,057
`24,585
`59.72
`59.49
`
`24,585
`
`24,586
`(1)
`
`IPR Page 3/13
`
`

`

`Quarterly consolidated statement of financial position
`
`(JPY millions)
`
`March 31, 2017
`
`December 31,2017
`
`28,550
`138,935
`29,889
`2,396
`2,124
`201,894
`
`157,011
`
`28,502
`70,970
`333
`
`3,909
`53,297
`
`358,906
`
`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
`Total current assets
`
`Total assets
`
`IPR Page 4/13
`
`IPR Page 4/13
`
`

`

`Equity and liabilities
`
`(JPY millions)
`
`March 31, 2017
`
`December 31,2017
`
`Equity
`Equity attributable to owners of the company
`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
`
`
`
`7,792
`8,417
`(10)
`223,283
`15,628
`255,110
`819
`
`255,929
`
`26,288
`1,900
`1,426
`17,963
`1,919
`49,496
`
`23,937
`17,649
`3,279
`1,372
`7,244
`53,481
`
`102,977
`
`358,906
`
`IPR Page 5/13
`
`IPR Page 5/13
`
`

`

`Quarterly consolidated statement of changes in equity
`
`Nine months ended December 31, 2016
`
`Share
`capital
`
`Capital
`surplus
`
`Treasury
`shares
`
`Retained
`earnings
`
`7,695
`
`8,389
`
`(24)
`
`221,945
`
`(JPY millions)
`
`Other components of equity
`
`Net gain or loss on
`financial assets
`Remeasurements
`of defined benefit measured at fair value
`plans
`through other
`comprehensive income
`18,676
`
`—
`
`Balance at April 1, 2016
`Comprehensive income
`Net profit for the period
`Other comprehensive income
`Total comprehensive income
`
`Transactions with owners
`Issuance of new shares
`
`Acquisition of treasury shares
`Disposals of treasury shares
`Cancellation of treasury shares
`Dividends
`Establishment of subsidiary with
`non-controlling interests
`Share-based payments
`Other
`Total transactions with owners
`
`Balance at April 1, 2016
`Comprehensive income
`Net profit for the period
`Other comprehensive income
`Total comprehensive income
`
`Transactions with owners
`
`Issuance of new shares
`Acquisition of treasury shares
`Disposals of treasury shares
`Cancellation of treasury shares
`Dividends
`Establishment of subsidiary with
`non-controlling interests
`Sha re-based payments
`Other
`Total transactions with owners
`Balance at December 31, 2016
`
`17,164
`
`—
`
`17,164
`
`—
`
`(5,256)
`(5,256)
`
`—
`
`40
`
`—
`
`40
`
`(69)
`(0)
`(0)
`
`(12,310)
`0
`12,325
`
`40
`
`(29)
`
`15
`
`(12,325)
`(10,751)
`
`2,385
`(20,690)
`
`—
`
`(2,381)
`(2,381)
`
`Other components of equity
`
`_
`53:52,
`translation
`adjustments
`2,611
`
`rights to
`shares
`716
`
`Total equity
`39:32:,
`the company
`
`Total
`
`22,003
`
`260,009
`
`5,650
`5,650
`
`—
`8,261
`
`—
`394
`394
`
`(10)
`-
`-
`—
`—
`
`_
`138
`(2,385)
`(2,257)
`20,141
`
`17,164
`394
`17,558
`
`70
`(12,380)
`0
`—
`(10,751)
`
`_
`138
`—
`(22,921)
`254,646
`
`—
`
`(10)
`
`138
`(4)
`124
`840
`
`“°i;:::;;:;""9
`
`:33;
`
`—
`
`(1)
`24
`23
`
`832
`
`832
`855
`
`260,009
`
`17,613
`418
`17,581
`
`70
`(12,380)
`0
`—
`(10,751)
`
`832
`138
`—
`(22,089)
`255,500
`
`IPR Page 6/13
`
`_ 6 _
`
`IPR Page 6/13
`
`

`

`Nine months ended December 31, 2017
`
`(JPY millions)
`
`Other components of equity
`Net gain or loss on
`financial assets
`Remeasurements
`of defined benefit measured at fair value
`plans
`through other
`comprehensive income
`9,470
`
`—
`
`Share
`capital
`
`Capital
`surplus
`
`Treasury
`shares
`
`Retained
`earnings
`
`7,792
`
`8,417
`
`(1 0)
`
`223,283
`
`27,332
`
`—
`
`—
`
`—
`
`27,332
`
`—
`
`2,854
`2,854
`
`Balance at April 1, 2017
`Comprehensive income
`Net profit for the period
`Other comprehensive income
`Total comprehensive income
`
`Transactions with owners
`
`Issuance of new shares
`
`Acquisition of treasury shares
`Dividends
`
`Changes in equity of subsidiary with
`non-controlling interests
`Share-based payments
`Other
`Total transactions with owners
`
`Balance at December 31, 2017
`
`119
`
`119
`
`(1)
`
`119
`
`7,911
`
`119
`
`8,536
`
`(1)
`
`(11)
`
`Other components of equity
`
`Subscription
`rights to
`shares
`
`Total
`
`(10,563)
`
`168
`
`(10,395)
`
`240,220
`
`—
`—
`
`(168)
`(168)
`12,156
`
`Total equity
`tattrlbutablef
`ttttJ owners 0
`e company
`
`Non-controlling
`interests
`
`Total
`equity
`
`825
`
`15,628
`
`255,110
`
`—
`7,155
`7,155
`
`(39)
`—
`—
`
`218
`(168)
`11
`22,794
`
`27,332
`7,155
`34,487
`
`200
`(1)
`(10,563)
`
`218
`-
`(10,146)
`279,451
`
`-
`
`(39)
`
`218
`
`179
`1,004
`
`819
`
`15
`99
`114
`
`838
`
`838
`1,772
`
`255,929
`
`27,348
`7,254
`34,602
`
`200
`
`(1)
`(10,563)
`838
`
`218
`
`(9,308)
`281,222
`
`(LT-:3:
`translatign
`.
`adjustments
`5,332
`
`4,301
`4,301
`
`Balance at April 1,2017
`Comprehensive income
`Net profit for the period
`Other comprehensive income
`Total comprehensive income
`
`Transactions with owners
`Issuance of new shares
`Acquisition of treasury shares
`Dividends
`
`Changes in equity of subsidiary with
`non-controlling interests
`Share-based payments
`Other
`Total transactions with owners
`
`Balance at December 31, 2017
`
`—
`9,633
`
`IPR Page 7/13
`
`IPR Page 7/13
`
`

`

`Quarterly consolidated statements of cash flows
`
`Nine months ended
`December 31,2016
`
`(JPY millions)
`Nine months ended
`December 31, 2017
`
`I . Cash flows from operating activities:
`Net profit for the period
`Depreciation and amortization
`Impairment losses
`Finance expense (income)
`Income tax expenses
`Decrease (increase) in trade and other receivables
`Decrease (increase) in inventories
`Increase (decrease) in trade and other payables
`Increase (decrease) in provisions and 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:
`Proceeds from withdrawal of time deposits
`Payments for acquisition of investments
`Proceeds from sales of investments
`Payment for acquisition of subsidiary
`Payments for acquisition of property, plant and equipment
`Proceeds from sale of property, plant and equipment
`Payments for acquisition of intangible assets
`Other
`Net cash flows from (used in) investing activities
`
`llI. Cash flows from financing activities:
`Proceeds from long-term loans
`Repayments of long-term loans
`Payment for acquisition of treasury shares
`Capital contribution from non-controlling interests
`Dividends paid
`Other
`
`Net cash flows from (used in) financing activities
`1V. Net increase (decrease) in cash and cash equivalents
`V. Cash and cash equivalents at the beginning of period
`VI. Effect of exchange rate changes on cash and cash equivalents
`VI. Cash and cash equivalents at the end of period
`
`17,163
`7,315
`351
`1,357
`6,756
`(7,830)
`(1,657)
`(1,932)
`(15)
`1,780
`23,287
`44
`681
`
`(42)
`(23,664)
`307
`
`19
`(1 16)
`1,364
`(19,064)
`(3,664)
`4
`(3,063)
`(240)
`(24,761)
`
`3,000
`(7,237)
`(12,380)
`832
`(10,646)
`69
`
`(26,362)
`(50,816)
`99,798
`(881)
`48,100
`
`
`
`IPR Page 8/13
`
`IPR Page 8/13
`
`

`

`Segment information
`
`Nine months ended December 31, 2016
`<Reportable segment>
`Pharmaceuticals
`
`Revenue:
`
`Other
`(Note:1)
`
`Total
`
`.
`Adjustments
`
`(JPY millions)
`Consolidated
`total
`
`External customers
`
`Intersegment
`
`Total
`Segment income (loss)
`(Note:2)
`
`148,364
`
`—
`
`148,364
`
`27,871
`
`2,302
`
`467
`
`2,769
`
`(383)
`
`150,667
`
`467
`
`151,133
`
`27,488
`
`—
`
`(467)
`
`(467)
`
`7
`
`Finance income
`
`Finance expenses
`Profit before tax
`
`150,667
`
`—
`
`150,667
`
`27,488
`
`874
`
`(4,443)
`23,919
`
`Notes:1."0ther" comprises operating segments other than the reportable segment, including the medical device operating segments.
`2.Segment income (loss) is based on operating profit.
`3.The assets of the "Pharmaceuticals" largely increase in comparison with a previous consolidated account end of the fiscal year by acquiring total stocks of lnnFocus, Inc., and
`having subsidized it.
`Because evaluation inspection about the acquisition of lnnFocus, Inc., was completed in the six months ended September 31, 2017, the financial statements in the nine
`months ended December 31, 2016 were calculated based on retroactively adjusted figures. The segment income(loss) in the nine months ended December 31, 2016 has not
`been changed.
`
`Nine months ended December 31, 2017
`
`(JPY millions)
`
`<Rii2r§fnt2§eiii2§“>
`
`(33;?)
`
`Total
`
`Adjustments
`
`6°”?3’l2‘la‘e"
`
`Revenue:
`
`External customers
`
`lntersegment
`
`Total
`Segment income (loss)
`(Note:2)
`
`166,142
`
`—
`
`166,142
`
`30,627
`
`2,450
`
`562
`
`3,012
`
`(540)
`
`168,592
`
`562
`
`169,154
`
`30,087
`
`—
`
`(562)
`
`(562)
`
`Finance income
`
`—
`
`Finance expenses
`Profit before tax
`
`168,592
`
`—
`
`168,592
`
`30,087
`809
`
`(1,357)
`29,539
`
`Notes:1."Other" comprises operating segments other than the reportable segment, including the medical device operating segments.
`2.Segment income (loss) is based on operating profit.
`
`Breakdown of revenues
`
`Nine months ended December 31, 2016
`
`Pharmaceuticals business
`
`
`Prescription pharmaceuticals
`
`Ophthalmics
`
`137,461
`
`
`orc
`pharmaceuticals
`
`
`
`
`Other businesses
`
`Medical
`devices
`
`(JPY millions)
`
`Tm?"
`
`150,667
`
`
`
`Other
`pharmaceuticals
`
`Nine months ended December 31, 2017
`Pharmaceuticals business
`Other businesses
`
`
`
`Prescription pharmaceuticals
`
`OTC
`Medical
`
`pharmaceuticals
`devices
`Ophthalmics
`
`
`
`168,592
`
`(JPY millions)
`
`me”
`
`
`
`153,788
`
`Other
`pharmaceuticals
`
`IPR Page 9/13
`
`_9_
`
`IPR Page 9/13
`
`

`

`(JPY millions)
`
`Year ended March 31, 2017
`Year ending March 31, 2013
`Nine months
`Nine months
`
`ended
`December 31,
`2016
`10140
`3,800
`5,380
`961
`
`Changes
`from“ 53"]:
`pa 0 0
`previous year
`12.0%
`(21.2%)
`(4.5%)
`10.6%
`
`Year ended
`March 31
`Actual
`12884
`4,660
`6,980
`1 245
`
`Changes
`fr”: 52m:
`pe o o
`previous year
`
`(21.3%)
`(0.3%)
`6.5%
`
`Changes
`fronrli sgmfe
`pe o o
`previous year
`12.8%
`(11.3%)
`29.1%
`16.3%
`
`Year ending
`March 31
`Forecasts
`14245
`4,308
`8,552
`1 384
`
`Changes
`"015:"?
`pe 0 0
`previous year
`10.6%
`(7.5%)
`22.5%
`11.2%
`
`11434
`3,369
`6,948
`1 118
`
`858
`
`1,760
`306
`12780
`
`6.5%
`
`73.9%
`-
`174.9%
`
`982
`
`2,256
`504
`16406
`
`9.8%
`
`63.4%
`229.3%
`
`832
`
`1,953
`109
`904
`13791
`
`3.0%
`
`10.9%
`438.5%
`195.1%
`
`983
`
`2,556
`136
`1 281
`18033
`
`0.1%
`
`13.3%
`260.3%
`154.0%
`10.2%
`
`(0.2%)
`36.6%
`14.9%
`—
`64
`—
`41
`-
`—
`-
`17020— 22164— 18622— 23013—
`
`(14.4%)
`(1.3%)
`36.5%
`
`1,614
`88
`679
`
`(14.4%)
`0.8%
`33.3%
`
`(12.2%)
`20.1%
`4.2%
`
`1,450
`100
`637
`
`(10.2%)
`13.1%
`1.1%
`10.1%
`(19.3%)
`3.3%
`(6.0%)
`293.4%
`
`Revenue of major pharmaceuticals
`
`Brand name
`Generic name/formulation
`
`Therapeutic
`category
`
`Region
`
`Cravit
`levofloxacin/ophthalmic solution
`
`Bacterial
`conjunctivitis
`
`Japan
`
`Tarivid
`ofloxacin/ophthalmic solution
`
`oo3c8:11S E
`
`E
`
`Tapmm
`tafluprost-timolol maleate/
`combination ophthalmic solution
`
`Tapros
`tafluprostjophthalmic solution
`
`Cosopt
`dorzolamide hydrochloride-timolol
`maleate/combination ophthalmic
`solution
`
`Timoptol
`timolol maleatel
`ophthalmic solution
`
`Timoptol XE
`timolol maleatel
`long-acting ophthalmic solution
`
`Trusopt
`dorzolamide hydrochloride!
`ophthalmic solution
`Rescula
`
`isopropyl unoprostone/
`
`.
`97
`.
`6
`.
`mm
`788
`(18.2%)
`967
`(18.1%)
`662
`(16.0%)
`797
`(17.6%)
`(16.9%)
`119
`(14.8%)
`86
`(4.3%)
`115
`(3.8%)
`290
`37.9%
`422
`30.6%
`435
`50.0%
`526
`24.7%
`1766
`1891
`1,303
`1,144
`66
`79
`522
`544
`
`(19.3%)
`(47.1%)
`
`(18.6%)
`(39.3%)
`17.2%
`.
`
`9
`
`(11.5%) m (11.5%)
`(11.5%)
`1,633
`(11.5%)
`
`1
`
`1,321
`1 321
`
`1,325
`232
`2,009
`22
`
`1 200
`1 200
`
`(4.2%)
`11.8%
`14.3%
`_
`
`(9.2%)
`(9.2%)
`
`1,396
`280
`2,194
`36
`
`1 641
`1,641
`
`Inflammation
`
`Asia
`
`22.0%
`22.0%
`(4.5%)
`15.9%
`
`
`
`mhmalmic solution
`e "13$ “18
`[DC Orl e
`h d
`Alesiorz,
`m ,d /
`op-hthalmic :olution
`Flumetholon
`fluorometholone/
`ohthalmic solution
`
`Kary Uni
`pirenoxine/
`ohthalmic solution
`Oftan Catachrom
`cytochrome C, adenosine,
`nicotinamide/
`o.hthalmic solution
`Opagan Hi
`sodium hyaluronate/
`ad'uvant for o-hthalmic o-erations
`
`Eflllilgsmepfl
`soulufion for imravitrea. Median
`Hyalein
`sodium hyaluronate/ophthalmic
`solution
`Diquas
`diquafosol sodium/ophthalmic
`solution
`
`Ikervis
`ciclosporinlophthalmic soulution
`
`Dry eye
`
`Cationorm
`
`Dry eye
`
`.
`
`6.292
`6,292
`2 520
`1,641
`878
`
`3 228
`2,271
`957
`
`1,798
`1198
`
`35,361
`35,361
`13 897
`9,529
`4 368
`9140
`8,496
`644
`
`1
`
`Asia
`
`Senile
`cataract
`
`Senile
`cataract
`
`Adiuvant for
`ophthalmic
`o-erations
`
`"m (real VEGF
`Inh'b'tor
`
`Dry eye
`
`
`Asia
`
`Asia
`
`
`
`13.3% m 12.9%
`45,155
`13.3%
`12.9%
`5
`12.1%
`11.4%
`
`11,852
`(18.1%)
`(18.2%)
`5 743
`4.6%
`6.9%
`26.4% m 24.0%
`26.8%
`11,016
`24.1%
`21.9%
`924
`23.1%
`163.1%
`1 303
`73.5%
`2
`1,301
`
`73.2%
`
`162.8%
`
`.
`
`‘
`.
`
`23.4%
`
`28‘1 %
`15.7%
`114.9%
`14.1%
`
`39.5%
`39.5%
`12.6%
`(15.3%)
`7.1%
`
`(1.1%)
`9.3%
`
`12,235
`12,235
`3 347
`2,224
`1 123
`
`4 124
`2,833
`1 291
`
`29.0%
`29.0%
`11.3%
`(16.2%)
`0.3%
`
`(2.3%)
`3%
`
`7 515
`7,515
`2 604
`1,566
`1 038
`
`3 518
`2,137
`1 331
`
`(11.3%) m (11.0%)
`(113%)
`21285
`(110%)
`
`1,830
`1,830
`
`19.4%
`19.4%
`(4.6%)
`16.2%
`
`14,926
`14,926
`3 425
`2,123
`1 302
`
`4 439
`9.0%
`(3.7%)
`2,776
`(2.0%)
`1 663
`23 %
`
`666%
`2’456
`“14%
`1.8%
`2,288
`13%
`2,288
`
`50,299
`50,299
`17 683
`10,743
`6 940
`14 874
`12,942
`1 932
`2 344
`64
`
`40,010
`40,010
`14124
`6,692
`5 432
`11 028
`9,937
`1 091
`1 661
`4
`1,657
`
`13.1%
`13.1%
`1.6%
`(8.8%)
`24.4%
`20.7%
`17.0%
`69.6%
`99.2%
`274.2%
`99.0%
`
`.
`
`'
`.
`
`11.4%
`11.4%
`
`(9.4%)
`20.8%
`24.6%
`17.5%
`109.0%
`79.9%
`
`431%
`2.4%
`101.7%
`11.5%
`
`
`
`OTC nharrnaceuticals
`
`9 552
`
`17.4%
`
`1
`12 553
`
`11 618
`
`21.6%
`
`2
`6
`14 000
`
`3rd quarter ended
`
`Fiscal year ended
`
`3rd quarter ended
`
`Fiscal year to March
`
` .
`
`US dollar
`Euro
`RMB
`"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.
`
`IPR Page 10/ 13
`
`_ 1 0 _
`
`IPR Page 10/13
`
`

`

`Research & development
`
`IPipeIine of prescription pharmaceuticals (Clinical Stage)
`
`As of February 6
`
`.
`-
`
`Indication
`D
`
`NDA Filed Approved
`Region
`Original/Licensor
`Generic name
`Merck Sharp &
`0 t-2017
`Ch'
`f
`|
`d'
`d'
`c
`Ina
`Dohme Corp. (U.S.)
`ry eye
`iqua 050 so ium
`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. Acquired import drug license in China in October 2017. 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.
`
`Original/Licensor
`
`I.
`.
`SII'O Imus
`
`DE 109
`-
`
`-——
`I -——
`.
`O.
`rigina -Europe——
`Apr-2015—
`An intravitreal injection with immunosuppressive effect, anti-angiogenic effect, etc. Received CRL from the US. FDA in December 2017 and the US, Europe and Japan are under
`consideration. NDA filed in Asia in April 2015.
`
`U
`
`.t.
`Val IS
`
`Dev. code Original/Licensor ----NDAFiIedAnvroved
`Genericname
`_
`_
`_
`_
`.
`Nippon Boehringer
`epinastine
`DE-114A Allergic conjunctivrtis
`.
`Japan
`,
`Ingelheim
`hydrochloride
`An HI
`receptor antagonist with membrane-stabilizing function, as treatment for allergic conjunctivitis, High dose drug. Started Phase 3 in Japan in May 2017.
`
`Generic name
`
`Dev. code
`
`Indication
`
`Original/Licensor
`
`Region
`
`NDA Filed Approved
`
`-——
`Co-development with
`Glaucoma/
`omidenepag
`J
`N m—
`ov
`Ube Industries
`Ocular hypertension
`isopropyl
`sia——
`An EP2 receptor agonist with a new mechanism of action. Completed Phase 2b in the US, in February 2015. Filed for manufacturing and marketing approval in Japan in November
`2017. Started Phase 3 in Asia in December 2016.
`
`-
`
`carotuximab
`
`
`
`
`
`
`Original/Licensor “IE-“NDAFM
`TRACON
`Wet A e—related
`_
`g
`_
`Pharmaceuticals
`macular degeneration
`An intravitreal injection of anti-endoglin antibody. Started Phase 2a in Philippines in July 2017 for development in the US.
`
`DE-122
`
`U.S.
`
`(Phase 2a)
`
`OriginaOI/Licensor
`(Phase2b))—
`PHARMACEUTICAL
`Ocular hyperten5ion
`p
`p
`A prostaglandin analogue eye drop drug product with a novel mode of action that is both FF and EP3 receptors dual agonist for the treatment of glaucoma and ocular hypertension.
`Started Phase 2b in the US. and Japan in July 2017.
`
`Original/Licensor
`Singapore Health
`Services, Nanyang
`Technological University
`Muscarinic antagonist which reduces juvenile myopia progression. Started Phase 2 in Asia in November 2017.
`
`atropine sulfate
`
`-
`
`'
`
`Asia
`
`(InnFocus
`
`Glaucoma
`
`Original
`
`Original/Licensor NDAFned Approved
`
`In August 2016, acquired InnFocus, developer of InnFocus MicroShunt, MicroShunt is a drainage implant device designed to lower and sustain intraocular pressure (IOP) for the
`treatment of primary open-angle glaucoma through the drainage of aqueous humor.
`
`—m Original/Licensor
`DE-07GB
`Severe keratitis in
`,
`.
`(Cyclokat)
`patients With dry eye
`
`ciclosporin
`
`Original
`
`-——
`Dec-2017
`
`Apr-2016—
`An ophthalmic emulsion to treat severe keratitis in adult patients with dry eye through an immunosuppressive effect. Cationic emulsion technology has enhanced ocular tissue
`absorption. Launched in Germany and England in July 2015 with successive launches following in European countries. Currently seeking sequential approvals for marketing in Asia
`and launched in Thailand in December 2017. NDAfiIed in Canada in April 2016.
`
`IPR Page 11/13
`
`IPR Page 11/13
`
`

`

`_
`_
`oiclosporin
`
`Vernal
`DE-076C
`_
`.
`.
`.
`keratoconiunctIVItIs
`(Vekacia)
`An ophthalmic emulsion which improves vernal keratoconjunctivitis by immunosuppressive effect. Cationic emulsion technology has enhanced ocular tissue absorption. NDA filed
`and granted Priority Review status in Europe in December 2016. In July 2017, the Committee for Human Medicinal Products of the European Medicines Agency adopted a positive
`
`Original/Licensor NDAFiIed Approved
`.
`.
`Original
`Europe
`Dec-201-
`
`opinion, recommending the marketing authorization.
`An ophthalmic emulsion of a prostaglandin an derivative, for the treatment of glaucoma and ocular hypertension.
`
`
`
`Generic name
`
`latanoprost
`
`Dev. code
`DE-130A
`(Catioprost)
`
`Indication
`Glaucoma/
`Ocular hypertension
`
`Original/Licensor
`
`Region
`
`NDA Filed Approved Launched
`
`Original
`
`IChanges from 02 FY17 (November 1, 2017)
`
`DE-109
`
`Received CRL from US. FDA in December 2017.
`
`DE-07SB (Cyclokat) Launched in Thailand in December 2017.
`
`Filed for manufacturing and marketing approval in Japan in November 2017.
`DE-117
`Started Phase 2 in Asia in November 2017.
`
`IPR Page 12/13
`
`_12_
`
`IPR Page 12/13
`
`

`

`Selling, general and
`administrative expenses
`520
`R&D expenses
`3,470
`2,554
`Consolidated total
`Note: Excluding amortization on intangible assets associated with products and long-term advance expense.
`
`918
`
`1,246
`
`709
`
`
`
`(JPY millions)
`Year
`ending
`March 31,2018
`
`Forecast
`
`1 .880
`
`1,270
`
`680
`
`3,830
`
`(JPY millions)
`Year
`ending
`March 31, 2018
`
`Forecast
`
`5,590
`680
`350
`
`6,620
`
`Other consolidated information
`
`(JPY millions)
`Capital expenditures
`
`Year
`Year
`Nine months ended
`Nine months ended
`
`ended
`ending
`December 31,2016
`December 31, 2017
`March 31,2017
`March 31,2018
`
`Forecast
`
`Consolidated
`
`
`
`Depreciation and amortization
`
`Nine months ended
`December 31,2016
`
`Year
`ended
`March 31,2017
`
`Actual
`
`Nine months ended
`December 31, 2017
`
`Manufacturing cost
`
`1,116
`
`1,515
`
`Amortization on intangible assets associated with products
`Year
`ended
`March 31, 2017
`
`Nine months ended
`December 31,2016
`
`Nine months ended
`December 31, 2017
`
`Intangible assets (Merck products)
`Intangible assets (lkervis)
`Other
`
`Consolidated total
`
`3,977
`503
`282
`
`4,761
`
`Actual
`
`5,357
`674
`381
`
`6,412
`
`
`
`(JPY millions)
`R&D expenses
`
`
`Year
`Year
`Nine months ended
`Nine months ended
`
`ended
`ending
`December 31,2016
`December 31, 2017
`March 31,2017
`March 31, 2018
`
`
`
`
`Forecast
`
`Consolidated
`
`
`Percent of revenue
`
`
`
`Actual
`
`*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,
`SIC.
`
`IPR Page 13/13
`
`_13_
`
`IPR Page 13/13
`
`