Securities Code: 4506
`
`for the Year Ended March 31, 2014
`
`Supplementary Financial Data
`
`|_
`
`Consofidated Financial Highlights ............................................................
`
`Consolidated Statements of (Comprehensive) Income ---------
`ll.
`III_ Consolidated Balance Sheets .....................................................................
`
`IV. Quartefly Business Results ...........................................................................
`
`V_ Major consolidated subsidiaries .................................................................
`
`VI_ Shareholder Positioning ..............................................................................
`
`VII. Development Pipeline --------- ~
`
`VIII. Profile of Major Products under Development -------------------------------
`
`1
`
`3
`7
`
`9
`
`9
`
`10
`
`11
`
`16
`
`May 8, 2014
`
`Dainippon Sumitomo Pharma Co, Ltd.
`
`_ Forecasts provided in this document are based on the management’s assumptions and
`beliefs, made in light of information available up to the day of announcement. Actual
`financial results may differ materially from those presented in this document, being
`dependent upon a number of factors.
`_ All values are rounded. Therefore totals may not be consistent with aggregated figures.
`
`Exhibit 2072
`
`Slayback v. Sumitomo
`|PR2020-01053
`
`LATUDA03177021
`
`Exhibit 2072
`Slayback v. Sumitomo
`IPR2020-01053
`
`1
`
`

`

`I. Consolidated Financial Highlights
`
`1. Consolidated Statements of income
`(Billions of yen)
`FY2014
`
`FY2014
`
`Net sales
`
`Cost of sales
`
`SG&A expenses
`
`SG&A expenses less R&D costs
`R&D costs
`
`FY2012
`
`.
`
`.
`
`.
`
`.
`.
`
`
`
`
`a
`Change (A2)
`11.5
`
`0
`Apr-Sep.
`(Forecast) Change (A)
`.
`.
`
`0
`(Forecast) Change (A)
`352.0
`(9.2)
`
`2.4
`
`6. 5
`16. 6
`
`.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`102.5
`
`229.5
`
`159.5
`70.0
`
`(1.5)
`
`(4. 9)
`
`(7.1)
`0 3
`
`387.7
`
`104.1
`
`241.5
`
`171. 6
`69.8
`
`Notes
`
`1: Cost of sales includes provision for (reversal of))reserve for sales returns.
`2. Change (%) represent ratio of changes from the corresponding period of the previous year.
`
`EBITDA (Billions of yen)
`
`Earnings per share (yen)
`
`Return on equity (ROE)
`Payout ratio
`
`60.3
`
`25.28
`
`3.0%
`71.2%
`
`68.1
`
`50.49
`
`5.4%
`35.7%
`
`21.0
`
`15.86
`
`——
`56.7%
`
`38.0
`
`30.20
`
`——
`59.6%
`
`2. Consolidated Statements of Cash Flows
`
`(Billions of yen)
`
`FY2012
`
`FY2013
`
`Net cash provided by operating activities
`
`Net cash used in investing activities
`Net cash used in financing activities
`
`Cash and cash equivalents at the end of period
`
`3. Currency Exchange Rates
`
`FY2013
`
`.
`FIscai year
`end rate
`
`Average
`rate
`
`FY2014
`I
`Assumed I
`rate
`I
`
`(Billions of yen)
`
`Forex senSItIVIty
`FY2014
`
`(impact of yen strength
`by 1yen/$)
`
`IhCOi’T‘E
`
`
`
`
`Note: Net sales and Operating income in FY2013 increased by 32.2 billion yen and 1.1 billion yen respectively, compared to the
`previous year due to exchange rate fluctuation.
`
`4. Capital Expenditures and Depreciation
`
`(Billions of yen)
`
`12.0
`9.5
`
`FY2014
`Change
`FY2013
`Forecast
`
`
`
`
`Capital expenditures
`
`10.4
`
`13.5
`
`3.1
`
` FY2012
`
`
`Depreciation and amoItization
`7.9
`8.8
`0.9
`Note: The amount of capital expenditures, depreciation and amortization for tangible fixed assets and software.
`
`-iVlajor capital expenditure projects completed in FY2013
`The New Chemistry Research Building in Osaka Research Center:
`(Total expenditures 5.8biilion yen,completed in Jun. 2013)
`
`—suppien§entary1 —
`
`LATUDA03177022
`
`2
`
`

`

`(Reference)
`Billions of en
`Financial Results for DSP
`
`Group-to—
`
`parent ratio
`Change (%)
`
`1.93
`Net sales
`5.?
`Cost of sales
`
`SG&A expenses
`SG&A expenses less R&D costs
`R8. D costs
`
`
`
`Operating income
`18.8
`23.9
`28.8
`1.76
`
`
`Ordinary income
`18.5
`
`
`Extraordinary income
`2.8
`
`Extraordinary loss
`50
`
`
`Net income
`15.2
`
`1.74
`
`1.31
`
`
`
`
`33.9
`
`
`
`Financial Results for Sunovion
`
`FY2012
`
`Cost of sales
`
`SG&A expenses
`SG&A expenses less R&D costs
`[amortization of patent rights and goodwill, etc]
`
`R& D costs
`
`(Millions of dollars)
`
`Change (%)
`
`(0-3)
`(24.2)
`
`(13.1)
`
`166
`
`1,132
`952
`
`Operating income
`
`Ordinary income
`Extraordinary income
`Extraordinary loss
`Net income
`
`Note: Total of Sunovion's result and amortization of goodwill.
`
`—supplementary2—
`3
`
`LATUDA03177023
`
`3
`
`

`

`174.3
`
`45.0%
`
`283.6
`241.5
`
`41.2 I
`
`30.9
`
`1
`
`3
`
`15.3
`9.3
`
`
`
`(0.8)
`35.5
`16.1
`4.9
`
`(0.5)l
`5.8 I
`1.9
`3.3 ‘
`
`40.6
`
`1
`16.1 I
`‘
`
`65.8
`
`
`
`10.0
`
`-2 6
`-.lapan Segment
`-North America Segment +294
`(FX rate impact +29 5)
`Other Regions Segment
`+7.4
`
`-lncrease by lower yen
`-Increase in North America
`
`-Increase by lower yen
`-Decrease In Japan / Increase In
`
`-Increase in Japan and North
`America (Boston Biomedical
`
`Inc)
`
`FY2012
`-lmpairmen loss for
`in—process R&D in North America
`FY2013
`-Impairmen loss for production facility!
`in—process R80 in North America
`-|mpairmen loss for idle assets in Japan
`
`FY2012:
`-Restructuring costs in North America
`-Transfer 0 assigned employees
`to related companies in Japan
`FY2013:
`-Restructuring costs in North America
`-Retiremen payments in Japan
`
`Il. Consolidated Statements of (Comprehensive) Income
`1. Consolidated Statements of Income
`
`(Billions of yen)
`
`FY2012
`FY2013
`‘
`
`(A)
`(B)
`(B)-(A)
`023/390
`Net sales
`347.7
`387.7
`40.0
`11.5
`
`Overseas sales
`
`[% of net sales]
`Cost of sales
`
`1% of net sales]
`Gross profit
`SG&A expenses
`
`Labor costs
`Advertising and promotion costs
`Sales promotion costs
`Othercosts
`
`SG&A expenses less R&D costs
`RaD costs
`
`[% of net sales]
`Operating income
`Non-operating income
`
`Non-operating expenses
`Ordinary income
`Extraordinan/ income
`Gain on sales of investment securities
`
`Fair value adjustment of contingent
`consideration
`
`Extraordinary loss
`
`Impairment loss
`
`Business structure improvement
`expenses
`
`133.1
`
`38.3%
`101.7
`
`29.2%
`246.0
`221.0
`
`66.0
`16.4
`11.8
`67.0
`
`161.2
`59.8
`
`17.2%
`25.0
`3.1
`
`3.6
`24.5
`—
`——
`
`__
`
`6.3
`
`0.4
`
`4.8
`
`
`
`North America and China -lncrease by lower yen
`
`
`Loss on litigation
`1 .1
`
`Income before income taxes and minority interests
`18.2
`Income taxes
`8.1
`
`Income before minority interests
`Net income
`
`10.0
`
`20.1
`
`10.0
`
`99.7
`
`Notes 1: Cost of sales includes provision for (reversal of) reserve for sales returns.
`2: Overseas sales includes exports of non—Pharmaceutical products.
`
`2. Consolidated Statements of Comprehensive Income
`
`(Billions of en)
`
`
`
`
`
`
`Income before minority interests
`Other comprehensive income
`Unrealized gains (losses) on available-
`for—sale securities, net of tax
`Deferred gains or losses on hedges
`Foreign currency translation adjustments
` Comprehensive income
`
`
`6.1
`
`21.0
`
`2.9
`
`(Q0)
`22.3
`
`Currency exchange rates yen/3
` 12/201212/2011 03/2013 03/2014
`
`
`
`77.7 s 86.6 94.0 a 102.9
`+8.9
`
`
`“supplenlentary3—
`
`LATUDA03177024
`
`4
`
`

`

`3. Segment Information (FY2013)
`
`(Billions of yen)
`
`Pharmaceuticals Business
`
`Other
`
`Ja an
`p
`
`North
`America‘1
`
`Amortization
`etc.
`
`Ch
`
`a
`
`in
`
`Other
`Regions
`
`Buslgess
`
`Tetal
`
`Netsales
`Sales to customers
`
`172.1 145.3-
`171.9
`145.3
`
`11.9
`11.9
`
`16.7 346.0- 387.7
`16.7
`345.8
`41.9
`387.7
`
`lntersegment
`Cost of sales
`
`0.2
`49.3
`
`—
`15.0
`
`60.8 52.0-
`
`2.
`
`6
`
`6
`
`3.2
`
`-—
`4.4
`
`0.2
`71.3
`
`(0.2)
`32.8
`
`——
`104.1
`
`11.4 109.2- 111.9
`
`
`Operating income
`40.4
`1.8
`42.1
`
`(Billions ofyen)
`
`Other
`Busjgess
`
`309.0
`
`0.1
`
`43.0
`
`(0.1)
`
`TOW
`
`3520
`352.0
`
`—-
`
`
`
`
`90.0
`
`Segment Information (FY2014 Forecast)
`
`Pharmaceuticals Business
`Amortization
`etc.
`
`North
`America*1
`
`Other
`Regions
`
`Sales to customers
`
`---
`169.0
`119.0
`13 2
`
`lntersegment
`
`0.1
`
`-—
`
`—-
`2.
`- 4
`-
`
`6.
`
`income (loss of segment
`R&D costs*3
`
`58.3
`
`31.6
`
`(8.6)
`
`3
`
`4.
`
`1 4
`.
`
`87.0
`69.0
`
`30
`.
`1.
`
`0
`
`70.0
`
`Notes *1: Excluding amortization of patent rights and goodwill, etc.
`*2:
`lncluding the elimination of intersegment transaction.
`*3: R&D costs are controlled globally and not allocated to each segment.
`
`“supplengentary4—
`
`LATUDA03177025
`
`5
`
`

`

`4. Sales of Pharmaceuticals Business (Sales to customers)
`
`FY2012
`(A)
`
`
`
`FY23013
`
`
`Change
`()%
`
`
`
`(Billions of yen)
`
`A2221:
`(Forecast)
`
`FY2014
`(Forecast)
`
`Japan
`North America
`
`174.5
`115. 8
`
`171. 9
`145. 3
`
`(2.6)
`
`(1.5)
`
`
`
`84.6
`60.9
`
`169.0
`119.0
`
`
`
`
`
`
`74
`4.1
`7.8
`
`
`
`
`
`
`Other Regions
`
`5. Sales of Major Products
`
`Japan(8trategic Products)
`
`
`
`(Sales figures before reduction of rebates, Billions of yen)
`
`FY2014
`FY2012
`Brand name (Generic name)
`A
`Apr.—Sep.
`Forecast
`
`Therapeutic indication
`(
`)
`(Forecast)
`(
`)
`
`
`
`PRORENAL® (limaprost alfadex)
`
`Vasodilator
`(O 7)
`(4 9)
`5'9
`1 1'6
`
`MEROPEN® (meropenem)
`Carbapenem antibiotic
`EBASTEL® (ebastine)
`Antiallergic
`EXCEGRAN® (zonisamide)
`
`Antiepileptic
`
`DOPS® (droxidopa)
`Noradrenergic neural function
`
`(O5)
`
`(13)
`
`8- (0'1)
`
`(48)
`
`(233)
`
`(3'6)
`
`4'2
`
`1'8
`
`1'6
`
`8'1
`
`4'6
`
`2'8
`
`3 0
`'
`
`2 9
`1 5
`
`'
`'
`
`—-supplementary5—
`6
`
`LATUDA03177026
`
`
`
`(3228013
`
`AIMIX® (irbesartan/amlodipine)
`Therapeutic agentfcr hypertensmn (Launch' Dec 2012)
`
`20
`
`AVAPRo® (irbesartan)
`Therapeutic agent for hypertension
`
`LONASEN® (blonanserin)
`Atypical antipsychotic
`
`TRERlEF® (zonisamide)
`Parkinson’s disease drug
`
`Japan (New Products)
`
`9 5
`'
`
`'
`
`Biguanide oral hypoglycemic (Launch May 2010)
`
`METGLuco® (metformin) 0--
`SUREPOST® (repaglinide) 7--
`
`Rapid-acting insulin secretagogue (Launch: May 2011 )
`
`Japan (Specialty Products)
`
`AmBisome® (amphotericin B)
`Therapeutic agent for systemic fungal infection
`
`MIRIPLA® (miriplatin hydrate)
`Therapeutic agent for hepatecellular Carcinoma
`
`REPLAGAL® (agalsidase alfa)
`Anderson—Fabry disease drug
`
`Japan(Others)
`
`Therapeutic agent for hypertension and angina pectoris
`
`GASlVlOTlN® (mosapride citrate)
`Gastroprokinetic
`
`(0 1)
`
`(1 2)
`
`(44)
`
`(22.8)
`
`FY2014
`
`12.8
`
`11 6
`'
`
`13 5
`'
`
`11 7
`'
`
`I
`
`161
`32
`
`5 4
`I
`
`1.0
`
`10'8
`
`11 4
`'
`
`55
`
`5 5
`'
`
`a 7
`'
`
`5 5
`'
`
`I
`
`7 9
`15
`
`2 6
`I
`
`05
`
`5'4
`
`5 9
`'
`
`
`
`AMLODIN®(amlodipine)
`:- (22)
`(75)
`115
`224
`
`
`
`
`
`6
`
`

`

`North America
`
`(Billions of yen)
`
`Brand name (Generic name)
`Therapeutic indication
`
`9/2012
`(A)
`
`szme,
`(B)
`
`_‘
`
`FY2014
`Apt-Sap.
`(Forecast)
`
`FY2014
`(Forecast)
`
`LU NESTA® (eszopiclone)
`Sedative hypnotic
`
`LATUDA® (lurasidone)
`Atypical antipsychotic (Launch: Feb. 2011)
`
`BROVANA® (arformoteroltartrate)
`Lo ng—acti ng betaagonist
`
`XOPENEX® (levalbuterol HCl)
`
`Short-acting beta»agonist
`
`ALVESCO® (ciclesonide)
`Inhaled corticosterOId
`
`
`OM NARIS® (ciclesonide)
`Corticosteroid nasal spray
`
`ZETONNA® (ciclesonide)
`Corticosteroid nasal spray (Launch: Jul. 2012)
`
`APTIOM® (eslicarbazepine acetate)
`Antiepileptic (Launch Apr. 2014)
`
`industrial property revenues
`
`China
`
`FY2014
`Apr.-Sep.
`-\
`Brand name (Generic name)
`(Forecast)
`(Forecast)
`
`
`(Billions of yen)
`FY201 4
`
`
`
`
`
`MEROPEN® (meropenem)
`
`.
`
`.
`
`.
`
`.
`
`5.6
`
`10.6
`
`Other Regions
`
`Brand name (Generic name)
`
`(Billions of yen)
`FY2014
`Apr—Sap.
`(Forecast)
`
`(2:22;;
`
`2
`
`MEROPEN® (meropenem) (Export)
`6.
`1 8
`EXCEGRAN® (zonisamide) (Export) -
`GASMOTIN® (mosapride citrate) (Export)
`industrial property revenues
`--0.-3
`
`0.
`
`(Reference) Sales of Products in North America Segment (based on local currency)
`
`(Millions of dollars)
`
`Brand name (Generic name)
`Therapeutic indication
`LUNESTA® (eszopiclone)
`
`sz012
`(A)
`
`FY2013
`(B)
`
`FY2014
`Apt—Sap.
`(Forecast)
`
`FY2014
`(Forecast)
`
`
`LATUDA® (lurasidone)
`
`BROVANA® (arformoterol tartrate)
`
`XOPENEX® (levalbuterol HCl)
`
`ALVESCO® (ciclesonide)
`
`OM NAR lS® (ciclesonide)
`
`ZETONNA® (ciclesonide)
`
`APTIOM® (eslicarbazepine acetate)
`
`industrial property revenues
`
`~5upplerr;entary6—
`
`LATUDA03177027
`
`7
`
`

`

`lIl. Consolidated Balance Sheets
`
`ASSETS
`
`(Billions of yen)
`
`As of
`Mar. 31,
`2013
`(A)
`
`
`
`As of
`Mar. 31,
`2014
`(B)
`
`607 2
`
`659 O
`
`(BI-(A)
`
`51.8
`
`26.2
`
`
`
`Allowance for doubtful receivables
`
`
`[ Assets
`
`]
`
`Current assets:
`
`Cash and time deposits
`Notes and accounts receivable
`
`Marketable securities
`
`Inventories
`
`Deferred tax assets
`
`Short-term loans receivable
`
`Others
`
`Fixed assets:
`
`Property, plant and equipment:
`
`Buildings and structures
`
`Machinery, equipment and carriers
`
`Land
`
`Construction in progress
`
`Others
`
`Intangible assets:
`Goodwill
`
`In—process research & development
`Others
`
`Investments and other assets:
`
`Investment securities
`
`Asset for retirement benefit
`
`Deferred tax assets
`
`Others
`
`Allowance for doubtful receivables
`
`Total assets
`
`Milestone revenue
`
`Impact of FX rate
`
`New Chemistry Research
`Building in Osaka Research
`Center(exc|uding depreciation)
`Buildings
`+4.5
`Construction in progress
`-2.3
`Others
`
`+1.3 Increase
`
`Amortization
`Currency
`
`+2.4
`—6.2
`+13.1
`
`m--
`4.5
`
`
`
` 0.2 (1-9)
`
`4.4
`
`7.2
`
`(2.7)
`2.7
`
`71.3
`
`50.7
`
`80.7
`
`56.1
`
`9.4
`
`5.4
`
`24.4
`20.1
`(4.3)
`"m
`
`
`
`Transfer
`Impairment
`Currency
`
`-0.6
`—4.3
`+102
`
`Patent rights, Sales rights, etc.
`
`securities of EdisonII
`
`Including aquisition of
`
`Accounts receivable turnover period
`(in months)
`
`3.35
`
`3.46
`
`“supplenéentaryT—
`
`LATUDA03177028
`
`8
`
`

`

`LlABILlTlES AND NET ASSETS
`
`(Billions of yen)
`
`As of
`Mar. 31,
`
`Mar. 31,
`2013
`
` As of
`2014
`
`258 O
`
`260 5
`
`[
`
`Liabilities
`
`]
`
`Current liabilities:
`
`Notes and accounts payable
`
`Current portion of bonds payable
`
`Current portion of long—term
`loans payable
`
`Income taxes payable
`
`Reserve for bonuses
`
`Reserve for sales returns
`
`Reserve for sales rebates
`
`Accounts payable—other
`
`Others
`
`Long-term liabilities:
`
`Bonds payable
`
`Long-term loans payable
`
`Deferred tax liabilities
`
`Reserve for retirement benefit
`
`Liability for retirement benefit
`
`Others
`
`[
`
`Net assets
`
`]
`
`Shareholders’ equity:
`Common stock
`
`Capital surplus
`
`Retained earnings
`
`Treasury stock
`
`Accumulated other comprehensive
`income (loss):
`
`Unrealized gains on available-for-
`sale securities, net oftax
`
`Deferred gains or losses on hedges
`
`Foreign currency translation adjustments
`
`
`Remeasurement of defined benefit plans
`
`
`
` 2 1
`Total liabilities and net assets
`
`
`
`Total interest-bearing debt
`115.0a950 (—20.0)
`
`
`+201
`Net income
`—7.2
`Payment of the dividend
`influence of fiscal year change —2.6
`(North America -2.9, China +0.3)
`
`Currency exchange rates: yenl$
`12/2012
`03/2014
`86.6 —> 102.9
`
`“supplementary8—
`
`LATUDA03177029
`
`9
`
`

`

`lV. Quarterly Business Results
`
`Net sales
`
`Cost of sales
`
`(Billions of yen)
`FY2013
`FY2012
`
`1Q
`
`89.1
`
`2Q
`
`89.7
`
`3
`
`Q
`
`4Q
`
`26.3
`
`25.3
`
`10
`
`89.6
`
`25.3
`
`2Q
`
`91.8
`
`25.2
`
`3Q
`
`103.1
`
`27.7
`
`4Q
`
`103.2
`
`26.0
`
`SG&A expenses
`SG&A expenses less R&D
`costs
`R&D costs
`12.1 20.8 19.9 14.7
`
`51.4
`
`39.3
`
`60.8
`
`40.9
`
`58.2
`
`58.2
`
`55.3
`
`40.6
`
`69.7
`
`48.9
`
`
`
`
`
`
`
`Operating income (loss)
`
`Non—operating income
`
`Non-operating expenses
`
`Ordinary income (loss)
`
`12.7
`0.8
`
`)
`
`(
`
`77
`
`08
`
`14
`
`9.1
`
`0.3
`
`10
`
`8.4
`
`9.0
`0.9
`
`0.5
`
`9.5
`
`0.3
`
`0.8
`
`7.9
`
`0.5
`
`0.8
`
`169
`
`0.4
`
`1.6
`
`6.3
`
`Extraordinary income
`
`Extraordinary less
`income (Loss) before income taxes
`and minority interests
`Net income (loss)
`
`8.4
`
`5.3
`
`(8.2)
`
`20
`
`(10.2)
`
`(68>
`
`3.8
`
`5.3
`
`6.5
`
`3.9
`
`0.
`
`0
`
`0.1
`
`16.8
`
`10.5
`
`1.0
`
`8.5
`
`4.8
`
`0.2
`
`3.6
`
`Note: Cost of sales includes provision for (reversal of) reserve for sales returns.
`
`V. Major consolidated subsidiaries (As of March 31 , 2014)
`DS Pharma
`.
`Animal Health
`Co., Ltd.
`July 2010
`
`Domestic
`
`Establishment
`
`DSP Gokyo
`Food & Chemical
`Co., Ltd.
`
`October 1947
`
`2.9 5‘ ()1
`
`
`
`sales of food
`
`
`pharmaceuticals
`704 390
`
`DS Pharma
`.
`.
`Biomedical Co., Ltd.
`June 1998
`
`100%
`
`64
`Manufacturing and
`sales of diagnostics,
`etc.
`
`Ownership
`
`Number of employees
`
`Businesses
`
`100%
`
`100%
`
`148
`Manufacturing and
`
`ingredients, food
`additives, chemical
`product materials, etc.
`
`Manufacturing, and
`sales of veterinary
`medicines, etc.
`
`Overseas
`
`Sunovion
`.
`Pharmaceuticals
`lnc.
`
`Boston
`Biomedical
`
`’
`
`Inc
`
`'
`
`Sumitomo
`.
`Pharmaceuticals
`(Suzhou) Co., Ltd.
`
`Establishment
`
`January 1984
`
`November 2006
`
`December 2003
`
`Ownership
`100%
`100%
`100%
`
`Number of employees
`1,565
`57
`743
`Manufacturing and
`R&D in the oncology
`Manufacturing and
`sales of
`area
`sales of
`pharmaceuticals
`
`Businesses
`
`(Reference) Number ofemployees and MRs
`As of
`Mar. 31, 2013
`7,218
`4,457
`
`non—consolidated
`
`consolidated
`
`Mar. 31, 2014
`
`1,410
`
`MRS Japan (excluding managers)- (including managers)
`(excluding managers)- (including managers)
`
`MRS U.S.
`
`1,610
`830
`940
` MRS China (excluding managers)
`
`350
`480
`(including managers)
`
`—-su
`
`lementa 9—
`10
`ry
`
`IDP
`
`LATUDA0317703O
`
`10
`
`

`

`Vl. Shareholder Positioning (As of March 31, 2014)
`
`1. Total number of authorized shares:
`
`1,500,000,000
`
`2. Total number of shares outstanding:
`
`397,900,154 (‘nc'Uding ”umber”
`treasury stock 593,962)
`
`3. Number of shareholders:
`
`4. Ma‘or shareholders:
`
`25,672
`
`Status of ownership
`
`Shareho‘ders
`
`Number of shares held
`(Thousand shares)
`
`Percentage of
`shareholding(%)
`
`199,434
`
`27,282
`
`15,574
`
`11,793
`
`
`
`Sumitomo Chemical Co., Ltd.
`
`lnabata & Co., Ltd.
`
`The Master Trust Bank of Japan, Ltd.
`(Trust account)
`
`Japan Trustee Services Bank, Ltd.
`(Trust account)
`
`Nippon Life Insurance Company
`
`Japan Trustee Services Bank, Ltd.
`(Trust account for Sumitomo Mitsui Banking
`Corporation‘s retirement benefits)
`
`Sumitomo Life insurance Company
`
`Aioi Nissay Dowa insurance Co., Ltd.
`
`Dainippon Sumitomo Pharma
`Employee shareholders’ association
`
`BNP Paribas Securities (Japan) Limited
`
`Notes:
`
`*1: Percentage of shareholding is calculated excluding treasury stock (593,962 stocks).
`*2: The numbers of shares held are rounded down to the nearest thousand shares.
`
`~5upplerqe12ntary10~
`
`LATUDA03177031
`
`11
`
`

`

`VII. Development Pipeline (As of May 8, 2014)
`
`Major Products under Development in Japan
`
`Stage in
`JPN
`
`Brand name/
`Product code
`
`Formulation
`
`Generic
`
`name
`
`Proposed
`Indication
`
`(Addition of
`METGLUCO®
`pediatric usage)
`Oral
`hydrochloride
`Type 2 diabetes
`
`
`Merck Santé
`
`Submitted in October
`2013
`
`metformin
`
`
`
`
`
`
`
`Submitted
`
`SUREPOST®
`Oral
`
`repaglinide
`
`Novo Nordisk
`
`Submitted in December
`2013
`
`Approved indication:
`The reduction of
`
`postprandial blood
`glucose in patients with
`type 2 diabetes
`(Monotherapy,
`Combination with d-Gl,
`BG and TZD)
`
`(New indication)
`Type 2 diabetes
`AII combination
`
`therapies
`including DPP-4
`inhibitors
`
`Diabetic
`
`AS-3201
`
`ranirestat
`
`Oral
`neuropathy
`
`
`Schizophrenia
`
`
`SM—1 3496
`
`lurasidone
`
`Oral
`
`hydrochloride
`
`Bipolar I
`depression
`
`Approved in the U.S.,
`Canada, Europe and
`Australia
`
`Approved in the U.S. and
`Canada
`
`Phase III
`
`Bipolar
`maintenance
`
`
`BBI608
`Oral
`
`Colorectal cancer
`
`(Monotherapy)
`
`Global clinical trial
`
`LONASEN®
`Oral
`
`blonanserin
`
`(Addition of
`pediatric usage)
`Schizophrenia
`
`Phase ||/ll|
`
`EPl—743
`
`Oral
`
`Leigh syndrome
`
`Edison
`
`Pharmaceuticals
`
`— supplementaryii ~
`
`12
`
`LATUDA03177032
`
`12
`
`

`

`St
`
`_
`age in
`JPN
`
`Brand name/
`Product code
`Formulation
`
`_
`Generic
`name
`
`d
`
`P
`
`ropose
`'"d'cam"
`
`Intercept
`Nona‘COhOI'C
`obeticholic
`DSP—1747
`.
`steatohepatitis
`.
`
`
`
`Oral Pharmaceuticals aCId (NASH)
`
`USP-6952
`
`Oral
`
`IBS with
`
`constipation,
`Chronic
`
`idiopathic
`
`constipation
`
`
`
`
`
`
`
`LONASEN®
`Transdermal
`
`blonanserin
`
`(New formulation
`(Do—development With
`Transdermal
`Nitto Denko
`_
`patch)
`
`Patch Approved dose. Oral Schizophrenia
`
`
`
`TRERIEF®
`Oral
`
`zonisamide
`
`Phase Illl
`
`M4?“
`'nJeCUOH
`
`DSP-3025
`
`(New indication)
`Parkinsonism in
`Dementia with
`
`Lewy Bodies
`(DLB)
`
`Myelodysplastic
`syndromes
`
`Bronchial
`
`Joint research
`with Chugai
`Pharmaceutical
`
`independent
`development after April
`2013
`
`In-house
`asthma, Allergic
`Coilunarium
`rhinitis
`
`WT4869
`
`independent
`Joint research
`development after April
`with Chugai
`Solid cancer
`Injection
`Pharmaceutical
`2013
`
`M2725
`Injection
`
`BBI608
`
`Oral
`
`Solid cancer
`
`Gastric cancer
`(Combination
`therapy)
`
`Jointresearch
`
`With Chugai
`
`independent
`development after April
`2013
`
`[Main revisions since the 3Q announcement of January 2014]
`
`USP—5990 (ceftaroline fosamil)
`
`Deleted due to discontinued development
`
`- supplementary12 —
`
`13
`
`LATUDA03177033
`
`13
`
`

`

`Major Products under Development in Foreign Markets
`
`Brand name/
`Product code
`Formulation
`
`Generic name
`
`Proposed
`indication
`
`Country/
`Area
`
`Approved
`/preparing
`for Launch
`
`LATUDA®
`Oral
`
`lurasidone
`
`hydrochloride
`
`Schizophrenia
`
`Australia
`
`Approved in March
`2014
`
`Epilepsy
`APHOM®
`eslicarbazepine
`(Adjunctive
`acetate
`Oral
`Approved in the
`therapy)
`US.
`Submitted in
`
`Submitted in June
`2013
`
`Submitted
`
`Amrubicin
`
`amrubicin
`
`Small cell lung
`cancer
`
`hydrochloride
`hydrochloride
`in Japan:
`Injection
`CALSED®
`Submitted in
`
`Blonanserin
`Oral
`
`blonanserin
`
`Schizophrenia
`
`August 2013
`Brand name
`
`September 2013
`Brand name
`
`in Japan:
`LONASEN®
`
`Global clinical trial
`
`
`
`
` eslicarbazepine Approved
`
`
`
`BBI608
`Oral
`
`Colorectal
`cancer
`
`(Monotherapy)
`
`Gastric cancer
`(Combination
`therapy)
`
`
`Global clinical trial
`
`SM—13496
`Oral
`
`
`Phase lll
`
`lurasidone
`
`hydrochloride
`
`LATUDA®
`Oral
`
`APHOM®
`Oral
`
`acetate
`
`Schizophrenia
`
`
`(New
`indication)
`Bipolar
`maintenance
`
`
`(New
`indication)
`MDD with
`mixed features
`
`(New
`indication)
`Epilepsy
`(Monotherapy)
`
`Approved in the
`U.S., Canada,
`Europe and
`Australia
`
`indication: Epilepsy
`(Adjunctive
`therapy)
`
`- supplementary13 —
`
`14
`
`LATUDA03177034
`
`14
`
`

`

`Brand name/
`Product code
`Formulation
`
`Generic name
`
`Proposed
`Indication
`
`Country/
`Area
`
`BBl608
`Oral
`
`Colorectal
`cancer
`
`(Combination
`therapy)
`
`Chronic
`From the former
`obstructive
`Elevation
`pulmonary
`Pharmaceuticals
`disease (COPD)
`
`Attention—deficit
`hyperactivity
`disorder(ADHD)
`
`SUN—101
`Inhalant
`
`glycopyrrolate
`bromide
`
`SEP—225289
`Oral
`
`
`
`
`
`
`Phase I/II
`
`BBl608
`Oral
`
`Solid cancer
`
`(Combination
`therapy)
`
`USP-2230
`
`Injection
`
`Neuropathic
`pain
`Oral
`
`Joint
`Independent
`Solid cancer,
`WT2725
`research
`Hematologic
`development
`cancer
`after April 2013
`
`In-house
`
`with Chugai
`
`BBl503
`
`Solid cancer
`
`In-house
`
`Oral
`(Monotherapy)
`
`SEP-363856
`
`Oral
`
`BBl608
`Oral
`
`Schizophrenia
`
`Gastrointestinal
`cancer
`
`(Combination
`therapy)
`
`* Phase l study of EPi-589 which was in-licensed from Edison Pharmaceuticals (in-licensed territories: Japan
`
`and North America) is ongoing in Europe by Edison Pharmaceuticals.
`
`[Main revisions since the SQ announcement of January 2014]
`
`APTIOM® (eslicarbazepine acetate)
`
`LATUDA® (lu rasid one hydrochloride)
`
`BBI608 (Gastric cancer / Combination therapy)
`USP-1053
`
`Deleted due to launch in the US
`
`(Launched in April 2014)
`Deleted due to approval for bipolar l
`depression in Canada (Approved in March
`2014)
`launch in
`Approved and preparing for
`Australia (Approved in March 2014)
`Newly added in Phase Iii in the US.
`Deleted due to discontinued development
`
`- supplementary14 —
`
`15
`
`LATUDA03177035
`
`15
`
`

`

`Major Products under Development by Licensees
`
`Generic / Product
`code
`
`Proposed Indication
`
`Status of development
`
`(Brand name in JPN)
`
`amrubicin
`
`Out—licensed to Sunesis Pharmaceuticals Inc. forthe
`worldwide territory in October 2003.
`AG-7352
`Phase l|| study ongoing in North America by Sunesis
`
`(Sunesis’ product code: SNS-595).
`Out-licensed to Celgene (former Pharmion) forthe
`US. and European territories in June 2005.
`Small cell lung cancer
`hydrochloride
`Phase ill study completed in the US. and Europe by
`
`(CALSED%
`Celgene.
`Out-licensed to Eisai for the worldwide territory,
`ranirestat
`excluding Japan, in September 2005.
`Diabetic neuropathy
`AS—3201
`Phase ll / lll study ongoing in the U.S., Canada and
`
`Europe by Eisai.
`
`
` Out-licensed to Chelsea Therapeutics for the
` Neurogenic orthostatic
`
`droxidopa
`(Dopsb
`
`hypotension,
`lntradialytic
`hypotension,
`Fibromyalgia
`
`DSP-3025
`
`Bronchial asthma,
`Allergic rhinitis
`
`iurasidone
`
`hydrochloride
`(SM—13496)
`
`Schizophrenia
`Bipolar disorder
`
`SMP-986
`
`Nocturia
`
`worldwide territory, excluding Japan, China, Korea
`and Taiwan in May 2006.
`NBA submitted in the US. by Chelsea for neurogenic
`orthostatic hypotension in September 2011.
`Complete Response Letter received from FDA in
`March 2012. Chelsea resubmitted to FDA in July
`2013 and obtained the approval in February 2014..
`Phase ll study offibromyalgia and phase II study of
`intradiaiytic hypotension completed by Chelsea.
`
`Entered into a development and marketing
`agreement in March 2005. AstraZeneca has the
`right forthe worldwide territory, excluding Japan,
`China, Korea and Taiwan.
`Phase ll study as a coilunarium was completed in
`Europe, while a Phase I study as an inhalant was
`started in the U.K. by AstraZeneca (AstraZeneca‘s
`product code: AZD8848).
`
`Entered into a license agreement with Takeda
`Pharmaceutical for co-development and exclusive
`commercialization for the European territory,
`excluding the U.K. in March 2011.
`Takeda submitted an MAA in Switzerland for
`schizophrenia in March 2012.
`Takeda submitted an MAA in Europe for
`schizophrenia in September 2012.
`Takeda obtained the approval for schizophrenia in
`Switzerland in August 2013.
`Out—licensed to Standard Chem. & Pharm. for
`Taiwan in August 2013, and submitted for
`schizophrenia in Taiwan in October 2013.
`Takeda obtained the approval in Europe for
`schizophrenia in March 2014.
`Out—licensed to Nippon Shinyaku Co., Ltd. for rights
`in Japan to develop and commercialize in March
`2013.
`Phase ll study ongoing in Japan by Nippon
`Shinyaku.(Nippon Shinyaku‘s product code: NS-986).
`
`[Main revisions since the SQ announcement of January 2014]
`
`Droxidopa(DOPS®)
`
`Lurasidone hydrochloride (SM-13496)
`
`for neurogenic
`approval
`Chelsea obtained the
`orthostatic hypotension in
`the US.
`in February
`2014.
`
`Takeda Pharmaceutical obtained the approval for
`schizophrenia in Europe in March 2014.
`
`- supplementary15 —
`
`16
`
`LATUDA03177036
`
`16
`
`

`

`VIII. Profile of Major Products under Development (As of May 8, 2014)
`
`APTIOM‘FD (eslicarbazepine acetate) Epilepsy
`ln-licensed from BIAL Portela & Ca, SA
`
`Sunovion obtained the approval of APTIOM® for
`A novel voltage—gated sodium channel inhibitor.
`use as adjunctive treatment of partial-onset seizures in the U.S.
`in November 2013 and launched in
`
`the U.S.
`
`in April 2014. The approval is based on three global studies which were jointly performed
`
`with BIAL. These were randomized, double-blind, placebo-controlled studies, which included more
`
`than 1,400 people living with partial-onset seizures inadequately controlled by one to three
`
`concomitant AEDs. This drug is expected to be an important new treatment option for people living
`
`with epilepsy.
`
`Development stage:
`
`Epilepsy (adjunctive therapy): Submitted in Canada
`
`Epilepsy (monotherapy):
`
`Phase III in the U.S.
`
`LATUDA®(Iurasidone hydrochloride) Schizophrenia, Bipolar disorder
`Developed in—house
`
`LATUDA® (lurasidone hydrochloride) is an atypical antipsychotic agent which is believed to have an
`affinity for dopamine D2, serotonin 5—HT2A and serotonin 5—HT7 receptors where it has antagonist
`
`effects.
`
`In addition, LATUDA is a partial agonist at the serotonin 5-HT1A receptor and has no
`
`appreciable affinity for histamine or muscarinic receptors.
`
`In the clinical studies supporting the U.S. FDA approval, the efficacy of LATUDA for the treatment of
`
`schizophrenia was established in four, short-term (6-week), placebo-controlled clinical studies in adult
`
`patients. In these studies, LATUDA demonstrated significantly greater improvement versus placebo.
`
`A total of five short—term placebo controlled clinical studies contributed to the understanding of the
`
`tolerability and safety profile of LATUDA. LATUDA was approved for the treatment of schizophrenia
`
`by the U.S. FDA in October 2010, and launched by Sunovion in the U.S.
`
`in February 2011. For the
`
`treatment of schizophrenia, LATUDA was launched in Canada in September 2012 and launched in
`
`Switzerland in September 2013 through a local subsidiary of Takeda Pharmaceutical, DSP’s partner
`
`in Europe. Takeda obtained the approval in Europe from European Commission in March 2014.
`
`In
`
`addition, LATUDA was approved in Australia in March 2014.
`
`For the treatment of bipolar I depression, LATUDA was approved as the first atypical antipsychotic
`
`indicated for the treatment of bipolarl depression as a monotherapy and as an adjunctive therapy to
`
`lithium or valproate by the U.S. FDA in June 2013. In addition, LATUDA was approved in Canada in
`March 2014.
`
`Development stage:
`
`Schizophrenia:
`
`Approved in March 2014 and preparing for launch in Europe and
`Australia
`
`Submitted in Taiwan by Standard Chem. & Pharm.
`
`Phase III in Japan and China
`
`Bipolar I depression:
`
`Phase III in Japan
`
`In
`
`addition, plans
`
`to
`
`submit
`
`an MAA in Europe
`
`by Takeda
`
`Bipolar maintenance:
`
`Phase III in the U.S., Europe and Japan, etc.
`
`MDD with mixed features:
`
`Phase III in the U.S. and Europe, etc.
`
`Pharmaceutical.
`
`(Phase III in Europe)
`
`- supplementary16 —
`
`17
`
`LATUDA03177037
`
`17
`
`

`

`ranirestat (AS-3201)
`
`Diabetic neuropathy
`
`Developed in-house
`
`AS—3201 is expected to alleviate diabetic neuropathy, a complication ofdiabetes, by inhibiting aldose
`
`reductase and thereby inhibiting the accumulation of intracellular sorbitol
`
`that causes diabetic
`
`neuropathy. This compound has a stronger inhibitory effect and is longer-acting compared to other
`
`drugs in this therapeutic area. Clinical studies have shown AS—3201 to have good penetration into
`
`nerve tissues,
`
`resulting in dose-dependent
`
`inhibition of intraneural accumulation of sorbitol and
`
`fructose. Based on the results of clinical studies, AS-3201 is expected to show improvement of
`
`neuronal function and symptoms related to diabetic neuropathy.
`
`AS—3201 was out—licensed to Eisai for the overseas territory in September 2005. Eisai is conducting
`
`Phase II / III studies in the U.S., Canada and Europe.
`
`Development stage: Phase III in Japan
`
`BBI608
`
`Solid cancer
`
`Developed in—house (Boston Biomedical, Inc.)
`
`BBI608 is a small—molecule compound with a novel mechanism that blocks cancer stem cell (cancer
`
`cell with stem cell-like properties) self-renewal and induces cell death in C80 as well as other
`
`heterogeneous cancer cells. By targeting cancer stem cells in addition to heterogeneous cancer cells,
`
`efficacy is expected in the current challenges in therapy against cancer, such as treatment resistance,
`metastasis and recurrence.
`
`Development stage:
`
`Colorectal cancer (monotherapy):
`
`Phase Ill in the U.S., Canada and Japan, etc.
`
`Gastric cancer (combination therapy with paclitaxel): Phase Ill in the U.S.
`
`Colorectal cancer (combination therapy with cetuximab, panitumumab or capecitabine):
`Phase II in the US. and Canada
`
`Solid cancer (combination therapy with paclitaxel):
`
`Phase VII in the U.S. and Canada
`
`Gastric cancer (combination therapy with paclitaxel): Phase I in Japan
`
`Gastrointestinal cancer (combination therapy with FOLFOX“, FOLFOX*1 and bevacizumab, CAPOXQ,
`FOLFIRIQ, FOLFIRI’Band bevacizumab, or regorafenib):
`Phase I in the us. and Canada
`*1 FOLFOX: Combination therapy with fluorouracil, |eucovorin, oxaliplatin
`
`*2 CAPOX: Combination therapy with capecitabine, oxaliplatin
`
`*3 FOLFIRI: Combination therapy with fluorouracil, |eucovorin,irinotecan
`
`EPI-743
`
`Leigh syndrome
`In—Iicensed from Edison Pharmaceuticals
`
`EPI—743 is to synchronize energy generation in the mitochondria with the counterbalancing of redox
`
`stress.
`
`It is expected to be a world first treatment for mitochondrial diseases beginning with Leigh
`
`syndrome.
`
`Development stage: Phase IIIIII in Japan
`
`Nonalcoholic steatohepatitis (NASH), Primary biliary cirrhosis (PBC)
`DSP—1747
`ln-Iicensed from Intercept Pharmaceuticals Inc. (lntercept’s product code: INT-747)
`
`DSP—1747 is an agonist to farnesoid X receptor (FXR) whose ligand is the primary human bile acid
`
`chenodeoxycholic acid, the natural endogenous FXR agonist. The compound is expected to be
`
`effective for hepatic dysfunction and hepatic fibrosis associated with an increase of bile acid in the
`liver.
`
`Development stage: Phase II in Japan for NASH. Phase II for PBC is under consideration.
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`- supplementary17 —
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`18
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`LATUDA03177038
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`18
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`

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`IBS with constipation, Chronic idiopathic constipation
`DSP-6952
`Developed in—house
`
`DSP—6952 is a high affinity serotonin—4 receptor partial agonist with enterokinetic effect. DSP-6952 is
`
`expected to be effective for lBS with constipation and chronic idiopathic constipation by increasing
`
`complete spontaneous bowel movement.
`
`Development stage: Phase II in Japan
`
`glycopyrrolate bromide (SUN-101)
`
`Chronic obstructive pulmonary disease (COPD)
`
`Developed in—house (Sunovion Pharmaceuticals inc.)
`
`SUN—101 is a proprietary solution formulation of glycopyrrolate bromide, delivered by a customized
`
`eFlow® Nebulizer System (originated by and licensed from PARl Pharma GmbH), which was
`developed to optimize medication delivery and allow ease of use. Including products on the market
`
`and in development
`
`in this therapeutic area, SUN-101 is currently the only LAMA (long-acting
`
`muscarinic antagonist) in nebulized form.
`
`Development stage: Phase II in the US.
`
`SEP-225289
`
`Attention—deficit hyperactivity disorder (ADHD)
`
`Developed in-house (Sunovion Pharmaceuticals lnc.)
`
`SEP-225289 is a DNRI that inhibits the reuptake of dopamine and norepinephrine. SEP-225289 is
`
`being developed as a once daily long-acting treatment that will be effective throughout the day.
`
`Because of its ability to maintain a stable concentration in blood levels all day,
`
`it is expected to be
`
`effective overthe course of the day.
`
`Development stage: Phase II in the U.S.
`
`Myelodysplastic syndromes (MDS), Solid cancer
`WT4869
`- Developed in house (Joint—research with Chugai Pharmaceutical)
`
`WT4869 is a therapeutic cancer vaccine candidate using a peptide derived from Wilms’ tumor gene 1
`
`(WT1) protein. VVT4869 is expected to treat patients with various