`
`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 31, 2018
`(Core basis *1)
`
`Yearto
`March 2018
`
`% change
`
`Revenue
`Core operating profit
`Core netprofit for the year
`Core netprofit for the yearattributable to owners of the company
`
`Core earnings per share (yen)
`Basic earnings per share (yen)
`
`(IFRS)
`
`Revenue
`Operating profit
`Profit before tax
`
`Netprofit for the year
`Netprofit for the year attributable to owners of the company
`
`Yearto
`March 2018
`
`% change
`
`Note 1:The consolidated forecasts of results for the year ending March 31, 2018, which were released on May10, 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 InnFocus. There wasnoresulting impact on operating profit. However, this PPA finalization resulted in a
`positive impact on FY16 core netprofit of 437 million yen and in a negative impact on FY16 netprofit of 1,330 million yen.
`
`*Others
`
`(1) Changesin significant subsidiaries during the term
`(changesin designated subsidiaries resulting in adjustment to the scope of consolidation): No
`Note: Santen Ventures, Inc. has newly become a consolidated subsidiary.
`
`(2) Changesin accounting policies and accounting estimates
`[i] Changesin 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] Numberof shares outstanding at the end of period (including treasury shares)
`December31, 2017 : 406,500,015
`March 31, 2017
`: 406,173,015
`
`[ ii] Numberof treasury shares at the end of period
`December31, 2017 :
`7,166
`March 31, 2017
`:
`6,646
`
`[ iii ] Average numberof outstanding shares (during the fiscal year ended December31)
`Third quarter ended December31, 2017: 406,304,134
`Third quarter ended December31, 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 roundedto the nearest million, except when otherwiseindicated.
`
`(Caution)
`Forecasts in this report are based on the currently available information. Actual results may differ materially depending on a numberof factors
`including adverse economic conditions, delays in new products launch, currency exchangerate, 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 expensesof 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
`
`Nine months ended
`December31, 2016
`
`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
`December31, 2017
`
`
`
`(JPY millions)
`
`IFRS basis
`
`Revenue
`Costof sales
`Grossprofit
`
`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 measuredat fair value
`through other comprehensive income
`Items that may be reclassified subsequently to profit or loss
`Foreign currencytranslation adjustments
`Other comprehensive income
`Total comprehensive income
`
`Profit attributable to
`
`Owners of the company
`Non-controlling interests
`Netprofit for the period
`Total comprehensive incomeattributable 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 netprofit for the period
`Basic core earnings per share (yen)
`Diluted core earnings per share (yen)
`
`Coreprofit attributable to
`Owners of the company
`Non-controlling interests
`Core netprofit for the period
`
`IPR Page3/13
`
`Nine months ended
`December31, 2016
`
`Nine months ended
`December31, 2017
`
`150,667
`33,057
`24,585
`59.72
`59.49
`
`24,586
`(1)
`
`24,585
`
`IPR Page 3/13
`
`
`
`Quarterly consolidated statementof financial position
`
`Assets
`
`(JPY millions)
`
`March 31, 2017
`
`December31, 2017
`
`157,011
`
`28,550
`138,935
`29,889
`2,396
`2,124
`201,894
`
`28,502
`70,970
`333
`
`3,909
`53,297
`
`358,906
`
`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
`Otherfinancial assets
`
`Othercurrent assets
`Cash andcashequivalents
`Total current assets
`
`Total assets
`
`IPR Page4/13
`
`IPR Page 4/13
`
`
`
`(JPY millions)
`
`March 31, 2017
`
`December31, 2017
`
`358,906
`
`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
`
`Equity and liabilities
`
`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-currentliabilities
`
`Financialliabilities
`Net defined benefit liabilities
`Provisions
`Deferred taxliabilities
`Other non-currentliabilities
`Total non-currentliabilities
`
`Currentliabilities
`
`Trade and other payables
`Otherfinancialliabilities
`Income tax payable
`Provisions
`Othercurrentliabilities
`Total current liabilities
`
`Total liabilities
`
`Total equity andliabilities
`
`IPR Page 5/13
`
`IPR Page 5/13
`
`
`
`Quarterly consolidated statement of changesin equity
`
`Nine months ended December31, 2016
`
`Share
`capital
`
`Capital
`surplus
`
`Treasury
`shares
`
`Stes
`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 measuredatfair value
`plans
`through other
`comprehensive income
`18,676
`
`al
`
`Balanceat April 1, 2016
`Comprehensive income
`Netprofit 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 ofsubsidiary with
`non-controlling interests
`Share-based payments
`Other
`Total transactions with owners
`
`Balanceat April 1, 2016
`Comprehensive income
`Netprofit 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 December31, 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
`;
`Total equity
`Foren
`supsrpton ee
`translation
`DOTS AG
`oe
`the company
`adjustments Se
`2,611
`716
`
`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
`
`(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
`
`Share
`capita
`
`ares a Retained
`surplus
`snares
`earnings
`
`7,792
`
`8,417
`
`(10)
`
`223,283
`
`(JPY millions)
`
`Other components of equity
`Net gain or loss on
`financial assets
`Remeasurements
`of defined benefit measuredatfair value
`plans
`through other
`comprehensive income
`9,470
`
`-
`
`-
`
`-
`
`-
`
`27,332
`
`-
`
`2,854
`2,854
`
`27,332
`
`119
`
`119
`
`(1)
`
`119
`
`7,911
`
`119
`
`8,536
`
`(1)
`
`(11)
`
`Other components of equity
`
`Subscription
`Foreign
`5
`currency
`translation a Total
`.
`shares
`adjustments
`5,332
`
`825
`
`15,628
`
`4,301
`4,301
`
`-
`9,633
`
`-
`7,155
`7,155
`
`(39)
`_
`-
`
`-
`218
`(168)
`11
`22,794
`
`-
`
`(39)
`
`218
`
`179
`1,004
`
`(10,563)
`
`168
`(10,395)
`
`240,220
`
`-
`
`-
`
`(168)
`(168)
`
`12,156
`
`Total equity
`attributable
`to ownersof
`th
`je company
`
`Non-controlling
`interests
`
`Total
`equity
`
`255,110
`
`27,332
`7,155
`34,487
`
`200
`(1)
`(10,563)
`
`-
`218
`-
`(10,146)
`279,451
`
`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
`
`Balanceat April 1, 2017
`Comprehensive income
`Netprofit for the period
`Other comprehensive income
`Total comprehensive income
`
`Transactions with owners
`
`Issuance of new shares
`
`Acquisition of treasury shares
`Dividends
`Changesin equity of subsidiary with
`non-controlling interests
`Share-based payments
`Other
`Total transactions with owners
`
`Balance at December31, 2017
`
`Balanceat April 1, 2017
`Comprehensive income
`Netprofit for the period
`Other comprehensive income
`Total comprehensive income
`
`Transactions with owners
`
`Issuance of new shares
`Acquisition of treasury shares
`Dividends
`Changesin equity of subsidiary with
`9
`4
`y
`"y
`non-controlling interests
`Share-based payments
`Other
`Total transactions with owners
`Balance at December31, 2017
`
`IPR Page 7/13
`
`IPR Page 7/13
`
`
`
`Quarterly consolidated statements of cash flows
`
`Nine months ended
`December31, 2016
`
`(JPY millions)
`Nine months ended
`December31, 2017
`
`I . Cash flows from operating activities:
`Netprofit 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
`Incometax paid
`Net cash flowsfrom (used in) operating activities
`
`I. Cash flows from investing activities:
`Proceeds from withdrawal of time deposits
`Payments for acquisition of investments
`Proceedsfrom sales of investments
`
`Paymentfor acquisition of subsidiary
`Payments for acquisition of property, plant and equipment
`Proceedsfrom sale of property, plant and equipment
`Payments for acquisition of intangible assets
`Other
`
`Net cash flows from (used in) investing activities
`
`II. Cash flowsfrom financingactivities:
`Proceeds from long-term loans
`Repayments of long-term loans
`Paymentfor acquisition of treasury shares
`Capital contribution from non-controlling interests
`Dividendspaid
`Other
`
`Net cash flowsfrom (used in) financing activities
`IV. Net increase (decrease) in cash and cash equivalents
`V. Cash and cash equivalentsat the beginning of period
`VI. Effect of exchange rate changes on cash and cash equivalents
`VI. Cash and cash equivalentsat the end of period
`
`IPR Page 8/13
`
`48,100
`
`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
`
`(116)
`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)
`
`IPR Page 8/13
`
`
`
`Segment information
`
`Nine months ended December31, 2016
`Pharmaceuticals
`
`(Note)
`
`Tota
`
`(JPY millions)
`Adjustments OMe
`
`Revenue:
`
`External customers
`
`Intersegment
`
`Total
`Segmentincome(loss)
`(Note:2)
`
`148,364
`
`-
`
`148,364
`
`2,302
`
`467
`
`2,769
`
`150,667
`
`467
`
`151,133
`
`_
`
`(467)
`
`(467)
`
`150,667
`
`—
`
`150,667
`
`27,488
`Finance income
`874
`
`“Financeexpenses(4,443)
`Profit before tax
`23,919
`
`27,871
`
`(383)
`
`27,488
`
`_
`
`Notes:1."Other" comprises operating segments other than the reportable segment,including the medical device operating segments.
`2.Segmentincome(loss) is based on operating profit.
`3.The assets of the "Pharmaceuticals" largely increase in comparison with a previous consolidated account endof the fiscal year by acquiring total stocks of InnFocus,Inc., and
`having subsidizedit.
`Because evaluation inspection about the acquisition of InnFocus, Inc., was completed in the six months ended September 31, 2017, the financial statements in the nine
`months ended December31, 2016 were calculated based onretroactively adjusted figures. The segment income(loss)in the nine months ended December 31, 2016 has not
`been changed.
`
`Nine months ended December31, 2017
`Pharmaceuticals
`
`(Note)
`
`Tota
`
`Adjustments
`
`Revenue:
`
`External customers
`
`Intersegment
`
`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
`
`(JPY millions)
`CONC
`
`168,592
`
`-
`
`168,592
`
`30,087
`809
`
`(1,357)
`Finance expenses
`
`
`“ProfitbeforetaxS«29,589
`
`Notes:1."Other" comprises operating segments other than the reportable segment,including the medical device operating segments.
`2.Segmentincome(loss) is based on operating profit.
`
`Breakdownof revenues
`
`Nine months ended December31, 2016
`
`
`
`Prescription pharmaceuticals
`OTC
`
`pharmaceuticals
`Ophthalmics
`
`Other
`pharmaceuticals
`
`137,461
`
`Other businesses
`
`Medical
`devices
`
`Pharmaceuticals business
`
`
`
`
`(JPY millions)
`
`Total
`
`150,667
`
`
`
`Nine months ended December31, 2017
`(JPY millions)
`
`Pharmaceuticals business
`Other businesses
`
`
`Prescription pharmaceuticals
`Total
`
`Medical
`OTC
`Others
`
`
`pharmaceuticals
`devices
`
`168,592
`
`
` Ophthalmics
`
`153,788
`
`Other
`pharmaceuticals
`
`IPR Page 9/13
`
`IPR Page 9/13
`
`
`
`
`Exchangerate (yen)
`
`Trusopt
`dorzolamide hydrochloride/
`ophthalmic solution
`Rescula
`isopropyl unoprostone/
`ophthalmic solution
`Alesion
`epinastine hydrochloride/
`ophthalmic solution
`Flumetholon
`fluorometholone/
`ophthalmic solution
`Kary Uni
`pirenoxine/
`ophthalmic solution
`Oftan Catachrom
`cytochromeC,adenosine,
`nicotinamide/
`
`Glaucoma
`
`Glaucoma
`
`Allergy
`
`Senile
`
`Senile
`cataract
`
`Japan
`Asia
`Eur
`
`1,383
`207
`1,751
`1
`
`(19.8%)
`(47.1%)
`29.2%
`-
`
`Asia
`
`Asia
`
`878
`
`957
`
`7.1%
`
`9.3%
`
`6
`1,509
`967
`119
`422
`2
`1,614
`88
`679
`
`1,731
`271
`2,333
`9
`
`1,123
`
`1,291
`
`1,144
`9
`7
`544
`
`1,325
`232
`2,009
`22
`
`(18.6%)
`(39.3%)
`17.2%
`-
`
`(10.2%)
`13.1%
`1.1%
`10.1%
`(19.3%)
`3.3%
`(6.0%)
`298.4%
`
`(4.2%)
`11.8%
`14.8%
`-
`
`1,396
`280
`2,194
`36
`
`0.3%
`
`3%
`
`1,038
`
`1,331
`
`18.2%
`
`1,302
`
`1,663
`
`15.9%
`
`28.8%
`
`0.1
`%
`Aduvantfor|rot|s7ae|(11.93%)|2.205](1.0%|1.830]18%|2,288|
`sodium hyaluronate/
`ophthalmic
`adjuvantfor ophthalmic operations
`operations
`1,798
`(11.3%)
`2,285
`(11.0%)
`1,830
`2,288
`
`an iravneavecr[Toa|ss9e[rae|sis]06
`soulutionfor intravitreal injection|_ihibitor
`Hyalein
`(9.4%)
`(8.8%)
`(18.1%)
`sodium hyaluronate/ophthalmic
`20.8%
`6,940
`24.4%
`6.9%
`5,743
`4.6%
`4,368
`Asia
`solution
`
`
`Diquas 26.4%|_—-11,940|24.0%9,140
`diquafosol sodium/ophthalmic
`8,496
`Dry eye
`26.8%
`11,016
`24.1%
`17.0%
`12,942
`17.5%
`solution
`644
`Asia
`21.9%
`924
`23.1%
`69.6%
`4,932
`109.0%
`163.1%
`1,303
`73.5%
`99.2%
`2,344
`79.9%
`-
`2
`64
`162.8%
`
`1
`
`B
`
`Dry eye
`
`-|T
`
`Ikervis
`ciclosporin/ophthalmic soulution
`
`6
`-
`-
`-
`-
`-
`
`
`otal|1,292|39.5% 1,835 26.3% 1,638 26.8% 2,587 41.0%
`
`
`
`
`Asia
`A
`:
`.
`.
`.
`Europe
`.
`.
`.
`.
`Cationorm
`North
`
`Dry eye
`
`OTC pharmaceuticals
`
`5
`9,552
`
`17.4%
`
`4
`12,553
`
`14.1%
`
`11,618
`
`21.6%
`
`2.
`14,000
`
`
`
`December31, 2016 December31, 2017_|31, 2018(ForecastsMarch 31, 2017
`US dollar
`Euro
`RMB
`*Forecastsin this report are based on the currently available information. Actual results maydiffer materially depending on a numberoffactors including adverse economic conditions,
`etc.
`
`
`
`IPR Page 10/13
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`- 10 -
`
`Revenue of major pharmaceuticals
`(JPY millions)
`
`Year ended March 31, 2017
`Year ending March 31, 2018
`Nine months
`Changes
`Year ended
`ended
`Changes
`Year ending
`from same
`from same
`March 31
`March 31
`[December31,
`period of
`period of
`2016
`Actual
`Forecasts
`previous year
`previous year
`Actual
`10,140
`12.0%
`12.8%
`3,800
`(21.2%)
`(11.3%)
`5,380
`(4.5%)
`29.1%
`961
`10.6%
`16.3%
`
`Brand name
`Generic name/formulation
`
`Therapeutic
`category
`
`Cravit
`levofloxacin/ophthalmic solution
`
`Bacterial
`conjunctivitis
`
`Total
`Japan
`Asia
`
`12,884
`4,660
`6,980
`1,245
`
`Changes Neos)
`from same
`period of
`previous year,
`
`(21.3%)
`(0.3%)
`6.5%
`
`11,434
`3,369
`6,948
`1,118
`
`Changes
`from same
`period of
`previous year
`10.6%
`(7.5%)
`22.5%
`114.2%
`
`14,245
`4,308
`8,552
`1,384
`
`Tarivid
`ofloxacin/ophthalmic solution
`
`Tapcom
`tafluprost-timolol maleate/
`combination ophthalmic solution
`
`Bacterial
`°Q°2.Cc3a= a
`
`Glaucoma
`
`Asia
`
`E
`
`1,760
`20
`306
`
`6.5%
`
`73.9%
`-
`174.9%
`
`982
`
`2,256
`38
`504
`
`9.8%
`
`63.4%
`229.3%
`
`832
`
`1,953
`109
`904
`
`3.0%
`
`10.9%
`438.5%
`195.1%
`
`983
`
`2,556
`136
`1,281
`
`0.1%
`
`13.3%
`260.3%
`154.0%
`
`Tapros
`tafluprost/ophthalmic solution
`
`Glaucoma
`
`-
`64
`-
`41
`-
`-
`-
`17,020| 8.3%|22164[ 7.7%|18,622| 9.4%|23,013[ 3.8%|Cosopt
`dorzolamide hydrochloride-timolol
`Glaucoma
`maleate/combination ophthalmic
`solution
`.
`Timoptol
`timolol maleate/
`ophthalmic solution
`
`Other
`
`Japan
`Eur
`
`3
`1,168
`788
`930
`290
`
`-
`
`24.1%
`(18.2%)
`(16.9%)
`37.9%
`
`Glaucoma
`
`-
`
`21.8%
`(18.1%)
`(14.8%)
`30.6%
`
`97
`1,183
`662
`86
`435
`
`-
`
`(16.0%)
`(4.3%)
`50.0%
`
`4,438
`797
`115
`526
`
`(17.6%)
`(3.8%)
`24.7%
`
`timolol maleate/
`Timoptol XE
`long-acting ophthalmic solution
`
`Glaucoma
`
`1,303
`66
`522
`
`(14.4%)
`(1.3%)
`36.5%
`
`(14.4%)
`0.8%
`38.8%
`
`(12.2%)
`20.1%
`4.2%
`
`1,450
`100
`687
`
`IPR Page 10/13
`
`
`
`Research & development
`
`Pipeline of prescription pharmaceuticals (Clinical Stage)
`
`As of February 6
`
`Original/Licensor
`Indication
`Generic name
`Merck Sharp &
`Dry
`eye
`diquafosol sodium
`DohmeCorp.(U.S.)
`ry ey!
`4
`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. Launchedin Vietnam in February
`2016. Launchedin Thailand in April 2016. Currently seeking sequential approvals for marketing in Asia.
`
`NDAFiled} Approved
`Oct-2017
`
`Region
`China
`
`Original/Licensor
`
`wok
`sirolimus
`
`bE-t09
`-
`
`Uveit
`veltls
`
`Original
`rigina
`
`Original/Licensor_|Region|Pi|P2_|P3_|NDAFiled] Approved|aunched
`epinastine
`|
`|
`oo
`Nippon Boehringer
`
`
`. DE-114A|Allergic conjunctivitis . Japan
`
`hydrochloride
`Ingelheim
`AnH,
`receptor antagonist with membrane-stabilizing function, as treatmentforallergic conjunctivitis. High dose drug. Started Phase3 in Japan in May 2017.
`
`Generic name
`
`.
`omidenepag
`isopropyl
`
`_|Dev. code
`
`Indication
`
`Original/Licensor
`
`.
`Glaucoma/
`Ocular hypertension
`
`:
`Co-developmentwith
`UbeIndustries
`
`NDAFiled] Approved
`Region
`pus[oo
`japan
`|OV-;
`Novs0i7 TOS
`
`An EP2 receptor agonist with a new mechanism of action. Completed Phase 2bin the U.S. in February 2015.Filed for manufacturing and marketing approvalin Japan in November
`2017. Started Phase 3 in Asia in December 2016.
`
`pus[|
`[Japan|
`|Europe|
`EuropefCT
`Apr2015]
`Anintravitreal injection with immunosuppressive effect, anti-angiogenic effect, etc. Received CRL from the U.S. FDA in December 2017 and the U.S., Europe and Japan are under
`consideration. NDAfiled in Asia in April 2015.
`
`andlaunchedin Thailand in December 2017. NDAfiled in Canada in April 2016.
`
`
`
`
`OriginalLicensor_|Region|Pi|P2_|P3_[NDAFiled] Approved|taunched
`Wet Age-related
`TRACON
`carotuximab
`DE-122
`9
`.
`.
`U.S.
`(Phase 2a)
`macular degeneration
`Pharmaceuticals
`Anintravitreal injection of anti-endoglin antibody. Started Phase 2ain Philippines in July 2017 for developmentin the U.S.
`
`Original/Licensor
`
`peree Ocularhypertension|PHARMACEUTICAL (Phase2b)|
`
`
`A prostaglandin analogue eye drop drug product with a novel modeofaction that is both FP and EP3 receptors dual agonistfor the treatment of glaucoma and ocular hypertension.
`Started Phase 2bin the U.S. and Japanin 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
`
`OriginaLicensor__[Region|P1_|P2_|_P3_|NOA ied] Approved|Launched|
`
`(InnFocus
`
`Glaucoma
`
`Original
`
`In August 2016, acquired InnFocus, developer of InnFocus MicroShunt. MicroShuntis a drainage implant device designed to lower and sustain intraocular pressure (IOP) for the
`treatmentof primary open-angle glaucomathrough the drainage of aqueous humor.
`
`|_Genericname[Dev.code|Indication_—|__OriginaLicensor_|Region|Pi|P2|P3_|NoAFiied|Approved]Launched]
`
`
`U
`pus[oo
`DE-076B
`Severekeratitis in
`
`
`icl Original|Asia|Dec-2017i
`
`
`
`ciclosporin (Cyclokat)|patients with dry eye ngina Apr2016
`ers
`pr2oie]
`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 Englandin July 2015 with successive launchesfollowing in European countries. Currently seeking sequential approvals for marketing in Asia
`
`IPR Page 11/13
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`IPR Page 11/13
`
`
`
`OriginavLicensor_|Region|Pi|P2_|P3_[NDAFiled] Approved|aunched
`,
`.
`DE-076C
`Vernal
`a:
`ciclosporin
`.
`oo.
`Original
`Europe
`Dec-2016
`(Vekacia)
`keratoconjunctivitis
`An ophthalmic emulsion which improves vernal keratoconjunctivitis by immunosuppressive effect. Cationic emulsion technology has enhanced ocular tissue absorption. NDAfiled
`
`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 opinion, recommending the marketing authorization.
`An ophthalmic emulsion of a prostaglandin F2a derivative, for the treatment of glaucoma and ocular hypertension.
`
`
`Generic name NDAFiled] Approved|LaunchedDev. code Indication Original/Licensor Region
`
`
`
`
`
`DE-130A
`Glaucoma/
`(Catioprost)
`Ocular hypertension
`
`latanoprost
`
`Original
`
`WiChanges from Q2 FY17 (November1, 2017)
`
`DE-109
`
`Received CRLfrom U.S. FDA in December2017.
`
`DE-076B (Cyclokat)|Launchedin Thailand in December 2017.
`
`DE-117
`
`Filed for manufacturing and marketing approval in Japan in November2017.
`Started Phase 2 in Asia in November 2017.
`
`
`IPR Page 12/13
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`-12-
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`IPR Page 12/13
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`
`
`Other consolidated information
`
`Capital expenditures
`(JPY millions)
`
`Year
` Year
`Nine months ended
`Nine months ended
`ended
`ending
`December31, 2016
`December31, 2017
`March 31, 2017
`March 31, 2018
`
`
`Actual
`Forecast
`Consolidated
`
`
`Depreciation and amortization
`
`Nine months ended
`December31, 2016
`
`Year
`ended
`March31, 2017
`
`Actual
`
`Manufacturing cost
`Selling,
`general and
`9:9
`.
`administrative expenses
`709
`520
`R&D expenses
`3,470
`2,554
`Consolidated total
`Note: Excluding amortization on intangible assets associated with products and long-term advance expense.
`
`1,116
`918
`
`1,515
`1,246
`
`Nine months ended
`December31, 2017
`
`
`
`(JPY millions)
`Year
`ending
`March 31, 2018
`
`Forecast
`
`1,880
`1,270
`
`680
`3,830
`
`(JPY millions)
`
`Year
`ending
`March31, 2018
`
`Forecast
`
`5,590
`680
`350
`
`6,620
`
`Amortization on intangible assets associated with products
`
`Nine months ended
`December31, 2016
`
`Year
`ended
`March31, 2017
`
`Actual
`
`Nine months ended
`December31, 2017
`
`Intangible assets (Merck products)
`Intangible assets (Ikervis)
`Other
`
`Consolidated total
`
`3,977
`503
`282
`
`4,761
`
`5,357
`674
`381
`
`6,412
`
`
`
`R&D expenses (JPY millions)
`
`
`Year
` Year
`Nine months ended
`Nine months ended
`ended
`ending
`December31, 2016
`December31, 2017
`March 31, 2017
`March31, 2018
`
`
` Forecast
`Actual
`
` Consolidated
`Percent of revenue
`
`*Forecasts in this report are based onthe currently available information. Actual results may differ materially depending on a numberoffactors including adverse economic conditions,
`etc.
`
`IPR Page 13/13
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