Securities Code: 4506
`
`for the Year Ended March 31, 2014
`
`Supplementary Financial Data
`
`Consolidated Financial HighlightsasMcnNeRUaNeeNeR 4
`L
`Consolidated Statements of (Comprehensive) Income ~~
`3
`ll.
`Ill Consolidated Balance Sheets vcecrcceccccrseeneteseesserenmmnressereenenereees
`7
`
`9
`IV. Quarterly BUSINESS RESUItSreertertctecictectenemnennees
`9
`Vv. Major CONSONIated SUBSICIATI OS mcrreteecenccnerteenernenecncosenuannenennene
`10
`VI. Shareholder Positioning em----necnnnnvencessecrnssnernseserneenenntnnernes
`
`11
`VII. Development Pipeline-----
`Vill. Profile of Major Products under Development ----- 16
`
`May 8, 2014
`
`Dainippon Sumitomo PharmaCo., 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 offactors.
`- All values are rounded. Therefore totals may not be consistent with aggregated figures.
`
`1
`
`Exhibit 2072
`Slayback v. Sumitomo
`IPR2020-01053
`
`LATUDA03177021
`
`Exhibit 2072
`Slayback v. Sumitomo
`IPR2020-01053
`
`1
`
`

`

`|. Consolidated Financial Highlights
`
`
`1. Consolidated Statements of Income
`(Billions of yen)
`FY2014
`FY2014
`és
`Apr.-Sep.
`“
`FY2012
`
`
`Change (%) (Forecast)|Change (%)(Forecast) Change (%)|
`Net sales 347.7 387.7 11.5 352.0 (9.2)
`
`
`
`
`
`
`
`Cost of sales
`
`SG&A expenses
`
`SG&A expenses less R&D costs
`
`R&D costs
`
`101.7
`
`221.0
`
`161.2
`
`59.8
`
`104.4
`
`241.5
`
`171.6
`
`69.8
`
`:
`
`;
`
`.
`
`102.5
`
`(1.5)
`
`0
`
`:
`
`0.0
`
`oe
`
`229.5
`
`159.5
`
`70.0
`
`(4.
`
`(7
`
`9)
`
`1)
`3
`
`)
`
`Netineome 63|ere [v0|03)
`
`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
`
`20.28
`
`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 usedin investing activities
`Net cash usedin financing activities
`
`Cash and cash equivalents at the end of period
`
`3. Currency Exchange Rates
`
`FY2013
`
`Fiscal year
`end rate
`102.9
`
`Average
`rate
`100.2
`
`FY2014
`Assumed
`rate
`
`(Billions of yen)
`Forex sensitivity
`FY2014
`(Impact of yen strength
`by tyen/$)
`100.0 | Net Sales
`|
`hceome
`
`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 exchangerate fluctuation.
`
`4. Capital Expenditures and Depreciation
`
`(Billions of yen)
`FY2014
`
`
`
`
`
`
`
`FY2013
`FY2012
`Change
`Forecast
`
`
`
`
`Capital expenditures
`
`12.0
`9.5
`
`Depreciation and amortization
`7.9
`8.8
`0.9
`Note: The amountof capital expenditures, depreciation and amortization for tangible fixed assets and software.
`
`10.4
`
`13.5
`
`3.1
`
`-Major capital expenditure projects completed in FY2013
`The New Chemistry Research Building in Osaka Research Center:
`(Total expenditures 5.8billion yen,completed in Jun. 2013)
`
`—supplementary’ —
`
`LATUDA03177022
`
`2
`
`

`

`(Reference)
`
`Group-to-
`parent ratio
`
`Net sales
`Cost of sales
`SG&A expenses
`SG&A expenses less R&D costs
`R&D costs
` Operating income
`
`
`
`
`Financial Results for DSP
`1.34
`Ordinary income Extraordinary income
`
`
`
`Extraordinary loss
`Net income
`:
`.
`2
`
`Financial Results for Sunovion
`
`(Millions of dollars)
`
`FY2012
`
`Change (%)
`Net sales 4,502|1499](0.3)0.3)
`
`Cost of sales
`166
`(24.2)
`
`SG&A expenses
`SG&A expenses less R&D cosis
`[amortization of patent rights and goodwill, etc]
`
`R&D costs
`
`,
`
`Operating income
`Ordinary income
`Extraordinary income
`Extraordinary loss
`Net income
`
`Note: Total of Sunovion's result and amortization of goodwill.
`
`—supplementary2—
`
`LATUDA03177023
`
`3
`
`

`

`FY2012|FY2013
`(A)
`(B)
`
`Net sales
`347.7
`387.7
`Overseas sales
`133.4
`174.3
`
`IL Consolidated Statements of (Comprehensive) Income
`1. Consolidated Statements of Income
`
`38.3%
`101.7
`
`29.2%
`246.0
`221.0
`66.0
`16.4
`11.8
`87.0
`164.2
`
`59.8
`17.2%
`25.0
`3.1
`
`3.6
`24.5
`
`[% of net sales]
`Cost of sales
`
`[% of net sales]
`Grossprofit
`SG&A expenses
`Labor costs
`Advertising and promotion costs
`Sales promotion costs
`Othercosts
`SG&A expenses less R&D costs
`
`R&D costs
`[% of net sales]
`Operating income
`Non-operating income
`
`Non-operating expenses
`Ordinary income
`Extraordinary income
`Gain on sales of investment securities
`
`Fair value adjustment of contingent
`consideration
`
`Extraordinary loss
`
`Impairment loss
`Business structure improvement
`expenses
`
` Net income
`
`
`
`Lossonlitigation
`18.2
`Income before income taxes and minority interests
`
`Income taxes 8.1
`10.0
`income before minority interests
`10.0
`
`
`«Increase in North America
`
`
`
`
`(Billions of yen)
`
`45.0%
`
`283.6
`241.5
`
`
`
`37.6
`20.5 |
`(0.5)
`5.8
`1.9 |
`3.3 |
`
`15.3
`9.3
`(0.8)
`35.5
`16.1
`49
`
`40.6
`
`16.1
`
`65.8
`
`20.1
`
`
`
`26
`«Japan Segment
`«North America Segment +29.4
`(FX rate impact +29.5}
`-Other Regions Segment
`+7.4
`
`‘Increase by lower yen
`
`‘Increase by lower yen
`«Decrease in Japan / Increase in
`North America and China
`
`“increase by lower yen
`-Increase in Japan and North
`America (Boston Biomedical,
`
`Inc.)
`
`FY2012
`loss for
`sImpairment
`in-process R&D in North America
`FY2013
`loss for production facility /
`“Impairment
`in-process R&D in North America
`«Impairment
`loss for idle assets in Japan
`
`FY2012:
`“Restructuring costs in North America
`-Transfer of assigned employees
`to related companies in Japan
`FY2013:
`*Restructuring costs in North America
`Retirement payments in Jepan
`
`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 yen)
`
`
`
`
`
`Income before minority interests
`
`Other comprehensive income
`
`Unrealized gains (losses) on available-
`Deferred gains or losses on hedges
`for-sale securities, net of tax
`Currency exchange rates:yen/$
`12/2011
`12/2012
`03/2013
`03/2014
`777 = 866
`940 > 1029
`21.0
`22.3
`+89
`Foreign currency translation adjustments
`+8.9
`
`|45.2]
`
`Comprehensive income
`
`~supplementarys—
`
`LATUDA03177024
`
`4
`
`

`

`Other
`Total
`Business
`J
`Other
`:
`North
`k
`Amortization
`
`
`Japan|americatt China Regions Subtotal 2
`
`
`3. SegmentInformation (FY2013)
`
`(Billions of yen)
`
`Pharmaceuticals Business
`
`
`
`
`
`
`
`
`Sales to customers
`
`171.9
`
`145.3
`
`11.9
`
`16.7
`
`345.8
`
`41.9
`
`387.7
`
`
`Intersegment
`0.2
`=
`_
`_
`0.2
`(0.2)
`=
`Costof sales
`49.3
`15.0
`2.6
`4.4
`71.3
`32.8
`104.14
`
`
`Operating income
`40.4
`1.8
`42.4
`
`SegmentInformation (FY2014 Forecast)
`Pharmaceuticals Business
`
`
`North
`+
`America*1
`
`Amortization
`ete.
`
`Other
`.
`Regions
`
`Subtotal
`
`Sales to customers
`
`169.0
`
`119.0
`
`13.2
`
`7.8
`
`309.0
`
`Intersegment
`
`0.1
`
`_
`
`-
`
`_
`
`0.1
`
`(Billions of yen)
`
`Other
`Business
`2
`
`43.0
`
`(0.4)
`
`Total
`
`352.0
`
`_
`
`SG&A expenses less R&D costs
`Income (loss) of segment 90.0 58.3 31.6 (8.6) 43 1.4 87.0 3.0
`
`
`
`R&D costs*3
`69.0
`1.0
`70.0
`
`
`
`
`
`
`
`
`
`
`
`Operating income
`
`18.0
`
`20.0
`
`Notes “1: Excluding amortization of patent rights and goodwill, etc.
`*2: Including the elimination of interseqment transaction.
`*3: R&D costs are controlled globally and not allocated to each segment.
`
`~~supplementary4—
`
`LATUDA03177025
`
`5
`
`

`

`
`
`
`
`
`
`Change(%)
`
`
`(Forecast)
`
`4. Sales of Pharmaceuticals Business (Sales to customers)
`
`
`
`(Billions of yen)
`
`Piv2014
`
`FY2014
`
`5 FY2013 Apl-Sep.|ieorecast)(B)
`
`Japan
`North America
`
`174.5
`115.8]
`
`171.9
`145.3
`
`(2.6)
`
`(1.5)
`
`84.6
`60.9]
`
`169.0
`119.0
`
`
`Other Regions
`93
`7.4
`41
`7.8
`
`
`
`5. Sales of Major Products
`Japan(Strategic Products)
`(Sales figures before reduction of rebates, Billions of yen)
`
`Brand name (Generic name) FY2014|evogyaFY2012
`
`A)
`Apr.-Sep.
`(Forecast)
`Therapeutic indication
`(
`(Forecast)
`
`
`
`
`
`
`
`AMLODIN®(amlodipine)
`:‘|= (2.2)
`
`
`
`
`
`
`
`
`AVAPRO®(irbesartan)
`Therapeutic agent for hypertension
`LONASEN®(blonanserin)
`Atypical antipsychotic
`2
`®
`.
`44.7
`55
`TRERIEF™ (zonisamide)
`Parkinson’s disease drug
`
`AIMIX® (irbesartan/amlodipine)
`Therapeutic agent for hypertension (Launch: Dec. 2012)
`
`,
`
`Japan (New Products)
`METGLUCO® (metformin)
`Biguanide oral hypoglycemic (Launch: May 2010)
`
`SUREPOST® (repaglinide)
`Rapid-acting insulin secretagogue (Launch: May 2011 )
`
`
`
`Japan (Specialty Products)
`AmBisome® (amphotericin B)
`5.4
`2.6
`Therapeutic agent for systemic fungal infection
`
`
`55
`
`55
`.
`
`6.7
`
`79
`
`1.5
`
`12.8
`
`446
`,
`
`13.5
`
`16.1
`
`3.2
`
`0.5
`
`5.4
`
`1.0
`
`10.8
`
`MIRIPLA® (miriplatin hydrate)
`Therapeutic agent for hepatocellular Carcinoma
`
`REPLAGAL® (agalsidase alfa)
`Anderson-Fabry disease drug
`
`Japan(Others)
`
`Therapeutic agent for hypertension and angina pectoris
`©
`.
`7:
`
`(7.5)
`
`(07)
`
`(0.5)
`
`45)
`
`(4.8)
`
`oe citrate)
`PRORENAL® (limaprost alfadex)
`
`MEROPEN®(meropenem)
`Carbapenem antibiotic
`EBASTEL®(ebastine)
`Antiallergic
`EXCEGRAN® (zonisamide)
`Antiepileptic
`DOPS®(droxidopa)
`Noradrenergic neural function
`
`11.5
`
`29-4
`
`59 4
`59
`46
`
`4.2
`
`8.1
`
`~~supplementaryS—
`
`LATUDA03177026
`
`
`
`6
`
`

`

`North America
`
`Brand name (Generic name)
`
`FY2012
`
`FY2013
`
`Change
`
`Therapeutic indication
`LUNESTA®(eszopicione)
`Sedative hypnotic
`
`LATUDA®(lurasidone)
`Atypical antipsychotic (Launch: Feb. 2041)
`
`16.1
`
`42.2
`
`BROVANA® {arformoteral tartrate)
`Long-acting beta-agonist
`
`12.7
`
`(Billions of yen)
`FY2014
`FY2014
`Apr.-Sep.
`(Forecast)
`(Forecast)
`
`XOPENEX® (levalbuterol HCl)
`25.3
`
`Short-acting beta-agonist
`
`ALVESCO® (ciclesonide)
`Inhaled corticosteroid
`
`Industrial property revenues
`
`OMNARIS® (ciclesonide)
`Corticosteroid nasal spray
`
`ZETONNA® (ciclesonide)
`Corticosteroid nasal spray (Launch: Jul. 2012}
`
`APTIOM® (eslicarbazepine acetate)
`Antiepileptic (Launch: Apr. 2044)
`
`
`
`China
`
`Brand name (Generic name)
`
`MEROPEN® (meropenem) (Export)
`
`(Billions of yen)
`FY2014
`Apr.-Sep.
`(Forecast)
`
`FY2014
`
`5.6
`
`10.6
`
`(Billions of yen)
`FY2014
`FY2014
`Apr.-Sep.
`(Forecast)
`(Forecast)
`
`FY2012
`(A)
`
`FY2013
`(B)
`
`5 1
`
`.3
`
`EXCEGRAN® (zonisamide) (Export)
`GASMOTIN® (mosapride citrate) (Export) a
`
`Industrial property revenues
`
`30
`
`pay|
`
`(Reference) Sales of Products in North America Segment (based on local currency)
`
`Brand name (Generic name)
`
`FY2012
`
`FY2013
`
`/
`
`Change
`
`Therapeutic indication
`LUNESTA®(eszopicione)
`
`18
`
`3.2
`
`(Millions of dollars)
`FY2014
`FY2014
`Apr.-Sep.
`(Forecast)
`(Forecast)
`
`5.4
`
`8.6
`
`(12.5)
`
`8 ) 3
`
`168
`
`(3)
`
`APTIOM® (eslicarbazepine acetate)
`
`5
`
`ots o
`
`aa
`I
`ap ml@a
`
`(Forecast) MEROPEN® (meropenem)
`© ack
`Other Regions Brand name (Generic name)
`Industrial property revenues f&N
`
`LATUDA®(lurasidone)
`424
`219
`108.4
`
`BROVANA® (arformoterol tartrate)
`XOPENEX® (levalbuterol HCI)
`ALVESCO® (ciclesonide)
`OMNARIS® (ciclesonide)
`ZETONNA® {ciclesonide}
`
`as
`
`14
`
`(57)
`
`—supplementaryo—
`
`LATUDA03177027
`
`7
`
`

`

`(Billions of yen)
`
`
`
`Impact of FX rate
`
`New Chemistry Research
`Building in Osaka Research
`Center(excluding depreciation)
`Buildings
`+45
`Construction in progress
`-2.3
`+1.3
`
` Milestone revenue
`
`ill. Consolidated Balance Sheets
`
`ASSETS
`
`[ 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, equipmentand carriers
`
`Land
`
`Construction in progress
`
`Others
`
`intangible assets:
`Goodwill
`
`in-process research & development
`Others
`
`investments and other assets:
`
`Investment securities
`
`Assetfor retirement benefit
`
`Deferred tax assets
`
`Others
`
`Allowance for doubtful receivables
`
`Total assets
`
`Accounts receivable turnover period
`(in months)
`
`Allowance for doubtful receivables
`
`
`Increase
`Amortization
`Currency
`
`Transfer
`Impairment
`Currency
`
`42.4
` -6.2
`+13.1
`
`-0.6
`43
`410.2
`
`Patent rights, Sales rights, etc.
`
`Including aquisition of
`securities of Edison
`
`4.4
`
`7.2
`
`
`
`~~Supplementary7—
`
`LATUDA03177028
`
`8
`
`

`

`Total interest-bearing debt
`115.0-95.0 (-20.0)
`
`
`(Billions of yen)
`
`As of
`Mar. 31,
`
`(A)
`
`f
`
`133.1
`
`129.3
`
`(3.9)
`
`LIABILITIES AND NET ASSETS
`
`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-termliabilities:
`
`Bonds payable
`
`Long-term loans payable
`
`Deferred tax liabilities
`
`Reserve for retirement benefit
`
`Liability for retirement benefit
`
`Others
`
`[_Netassets
`
`|
`
`
`
`
`
`
`;2
`
`.
`
`.
`
`+20.1
`Net income
`7.2
`Paymentof the dividend
`Influence of fiscal year change -2.6
`(North America -2.9, China +0.3)
`
`Shareholders’ equity:
`Common stock
`
` Capital surplus
`
`Retained earnings
`
`Treasury stock
`
`Accumulated other comprehensive
`income (loss):
`
`Unrealized gains on available-for-
`sale securities, net of tax
`
`Deferred gains or losses on hedges
`
`;
`
`.
`
`:
`
`;
`
`Currency exchange rates: yen/$
`Foreign currency translation adjustments
`12/2012=03/2014
`
`
`Remeasurementof defined benefit plans
`.
`.
`
`86.6 — 102.9
`
`Total liabilities and net assets
`
`~Supplementary8—
`
`LATUDA03177029
`
`9
`
`

`

`IV. Quarterly Business Results
`
`(Billions of yen)
`FY2012 FY2013
`
`
`
`
`
`Cost of sales
`
`26.3
`
`25.3
`
`25.3
`
`25.2
`
`27.7
`
`26.0
`
`58.2
`
`58.2
`
`SG&A expenses
`SG&A expenses less RED
`48.9
`40.6
`409]
`39.3}
`a
`
`
`
`
`12.1 19.9 14.7R&D costs 20.8
`2.
`7
`9.0
`7.5
`12.7
`(7.7)
`0.
`8
`0.8
`
`Net income (loss)
`
`
`
`
`
`
`
`Operating income (loss)
`Non-operating income
`
`;
`0.3
`
`0.9
`
`0.3
`
`0.5
`
`4
`
`Non-operating expenses
`
`Ordinary income (loss)
`
`Extraordinary income
`
`Extraordinary loss
`Income (Loss) before income taxes
`and minority interests
`
`7
`
`12.8
`_
`
`2.
`
`1.0
`
`8.4
`_
`
`bc
`
`82)
`
`02)
`
`(6.8)
`
`0.8
`
`—
`
`3.8
`
`1.6
`
`3
`2
`
`0
`
`3
`
`0.0
`
`
`
`0.1.
`
`=|
`3.9|
`
`8
`
`76
`105] 09]
`
`Note: Cost of sales includes provision for (reversal of) reserve for sales returns.
`
`V. Major consolidated subsidiaries (As of March 31, 2014)
`
`.
`Domestic
`
`Establishment
`
`Ownership
`
`Number of employees
`
`Businesses
`
`Overseas
`
`Establishment
`
`Ownership
`
`Number of employees
`
`Businesses
`
`DSP Gokyo
`:
`Food & Chemical
`Co., Ltd,
`October 1947
`
`DS Pharma
`:
`Animal Health
`Co., Ltd.
`July 2010
`
`DS Pharma
`‘
`4
`Biomedical Co., Ltd.
`June 1998
`
`100%
`
`100%
`
`100%
`
`148
`Manufacturing and
`sales of food
`ingredients, food
`additives, chemical
`product materials, etc.
`
`Manufacturing, and
`sales of veterinary
`medicines, etc.
`
`64
`Manufacturing and
`sales of diagnostics,
`etc.
`
`Sunovion
`Pharmaceuticals
`Inc.
`
`Sumitomo
`Boston
`Inc
`Pharmaceuticals
`Biomedical.
`_— (Suzhou) Co., Ltd.
`
`January 1984
`
`November 2006
`
`December 2003
`
`100%
`
`100%
`
`100%
`
`1,565
`Manufacturing and
`sales of
`pharmaceuticals
`
`5
`R&D in the oncology
`area
`
`743
`Manufacturing and
`sales of
`pharmaceuticals
`
`(Reference) Number of employees and MRs
`
`consolidated
`non-consolidated
`
`Mar. 31, 2014
`
`Mar. 31, 2013
`7,218
`4,457
`
`
`MRs Japan|(excluding managers) 1,410 1,400
`
`=
`(including managers)
`1,610
`1,600
`
`
`
`feSeames|e]
`
`350
`i
`i
`MRsChina|(excluding managers) 390
`
`470
`(including managers)
`480
`
`—supplementary9—
`pp 10
`ry
`
`LATUDA03177030
`
`10
`
`

`

`VI. Shareholder Positioning (As of March 31, 2014)
`
`1. Total number of authorized shares:
`
`1,500,000,000
`
`397,900,154 (Including numberof
`treasury stock 593,962)
`
`25,672
`
`Status of ownership
`
`Numberof shares held
`(Thousand shares)
`
`Percentage of
`shareholding(%)
`
`199 434
`
`21,282
`
`2. Total numberof shares outstanding:
`
`3. Number of shareholders:
`
`4. Major shareholders:
`
`Shareholders
`
`Sumitomo Chemical Co., Ltd.
`
`Inabata & Co., Ltd.
`
`The Master Trust Bank of Japan, Ltd.
`(Trust account)
`
`Japan Trustee Services Bank,Ltd.
`(Trust account)
`
`Japan Trustee Services Bank, Lid.
`(Trust account for Sumitomo Mitsui Banking
`Corporation’s retirement benefits)
`
`
`
`Dainippon Sumitomo Pharma
`Employee shareholders’ association
`
`BNP Paribas Securities (Japan) Limited
`
`3,334
`
`Notes:
`
`*1: Percentage of shareholding is calculated excluding treasury stock (593,962 stocks).
`*2: The numbers of shares held are rounded downto the nearest thousand shares.
`
`supplementary! O—
`
`LATUDA03177031
`
`11
`
`

`

`Vil. DevelopmentPipeline (As of May 8, 2014)
`
`Major Products under Development in Japan
`
`Stage in
`JPN
`
`Brand name/
`Product code
`
`Formulation
`
`Generic
`
`name
`
`Proposed
`indication
`
`Origin
`
`Remarks
`
`METGLUCO®
`Oral
`
`metformin
`
`(Addition of
`pediatric usage )
`hydrochloride
`Type 2 diabetes
`
`
`Merck Santé
`
`Submitted in October
`2013
`
`Pharmaceuticals
`
`
`
`
`
`Submitted
`
`SUREPOST®
`Oral
`
`repaglinide
`
`Novo Nordisk
`
`Submitted in December
`2013
`
`Approvedindication:
`The reduction of
`
`posiprandial blood
`glucose in patients with
`type 2 diabetes
`(Monotherapy,
`Combination with a-Gl,
`BG and TZD)
`
`(New indication)
`Type 2 diabetes
`All combination
`
`therapies
`including DPP-4
`inhibitors
`
`Diabetic
`
`AS-3201
`
`ranirestat
`
`Oral
`neuropathy
`
`
`Schizophrenia
`
`
`Approved in the ULS.,
`Canada, Europe and
`Australia
`
`SM-13496
`
`lurasidone
`
`Oral
`
`hydrochloride
`
`Bipolar |
`depression
`
`In-house
`
`Approved in the U.S. and
`Canada
`
`PhaseIII
`
`Bipolar
`maintenance
`
`
`BBI608
`Oral
`
`Colorectal cancer
`
`(Monotherapy)
`
`In-house
`
`Global clinical trial
`
`LONASEN®
`Oral
`
`blonanserin
`
`(Addition of
`pediatric usage )
`Schizophrenia
`
`in-house
`
`PhaseII/ll
`
`EPI-743
`
`Oral
`
`Leigh syndrome
`
`Edison
`
`- supplementary11 -
`
`12
`
`LATUDA03177032
`
`12
`
`

`

`Stage in
`JPN
`
`Brand name/
`Product code
`
`Formulation
`
`Generic
`
`name
`
`Proposed
`indication
`
`Origin
`
`DSP-1747
`
`obeticholic
`Intercept
`steatohepatitis
`Pharmaceuticals
`acid
`Oral
`(NASH)
`
`
`Nonalcoholic
`
`DSP-6952
`
`Oral
`
`IBS with
`
`constipation,
`Chronic
`
`In-house
`
`idiopathic
`
`constipation
`
`Phase Il
`
`LONASEN®
`Transdermal
`
`blonanserin
`
`(New formulation
`~ Transdermal
`
`In-house
`
`Co-developmentwith
`Nitto Denko
`
`patch)
`Patch
`Approved dose: Oral
`
`Schizophrenia
`
`2013
`
` 2013 WT2725 independent
`
`
`
`
`TRERIEF®
`Oral
`
`zonisamide
`
`Phase IAI
`
`WT4869
`
`Injection
`
`(Newindication)
`Parkinsonism in
`Dementia with
`
`Lewy Bodies
`(DLB)
`
`Myelodysplastic
`syndromes
`
`Bronchial
`
`In-house
`
`Joint research
`
`with Chugai
`Pharmaceutical
`
`Independent
`developmentafter April
`2013
`
`DSP-3025
`
`In-house
`asthma, Allergic
`Collunarium
`
`rhinitis
`
`Phase|
`
`WT4869
`
`Injection
`
`Injection
`
`BBI608
`
`Oral
`
`Solid cancer
`
`Solid cancer
`
`Gastric cancer
`(Combination
`therapy)
`
`Joint research
`
`with Chugai
`Pharmaceutical
`
`Joint research
`
`with Chugai
`
`in-house
`
`independent
`developmentafter April
`
`developmentafter April
`
`[Main revisions since the 3Q announcementof January 2014]
`
`DSP-5990 (cefiaroline fosamil)
`
`Deleted due to discontinued development
`
`- supplementary12 -
`
`13
`
`LATUDA03177033
`
`13
`
`

`

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

`

`Brand name/
`Product code
`Formulation
`
`Generic name |
`
`Proposed
`Indication
`
`Country/
`Area
`
`Remarks
`
`Colorectal
`cancer
`
`In-house
`
`In-house
`
`Canada
` US.,
`
`
`
`
`BBI608
`Oral
`(Combination
`therapy)
`
`Chronic
`From the former
`glycopyrrolate |
`SUN-101
`obstructive
`Elevation
`Inhalant
`bromide
`pulmonary
`|
`Pharmaceuticals
`_ disease (COPD)
`
`| Attention-deficit
`|
`hyperactivity
`| disorder (ADHD)
`
`PhaseIl
`
`SEP-225289
`Oral
`
`PhaseIll
`
`BBIs08
`Oral
`
`Solid cancer
`
`(Combination
`therapy)
`
`In-house
`
`US.,
`Canada
`
`DSP-2230
`
`WT2725
`
`Injection
`
`Neuropathic
`In-house
`pain
`Oral
`
`Joint
`Independent
`research
`development
`after April 2013
`
`Solid cancer,
`Hematologic
`cancer
`
`with Chugai
`
`Phase|
`
`BBI503
`
`Solid cancer
`US.,
`Canada
`(Monotherapy)
`Oral
`
`
`in-house
`
`SEP-363856
`
`BBI608
`Oral
`
`US.
`Schizophrenia
`Oral
`
`| Gastrointestinal
`cancer
`(Combination
`therapy)
`
`In-house
`
`* Phase I study of EP|-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 3Q announcement of January 2074]
`
`APTIOM® (eslicarbazepine acetate)
`
`LATUDA® (lurasidone hydrochloride)
`
`BBI608 (Gastric cancer / Combination therapy)
`DSP-1053
`
`Deleted due to launchin the U.S.
`(Launched in April 2014)
`Deleted due to approval for bipolar |
`depression in Canada (Approved in March
`2014)
`launch in
`Approved and preparing for
`Australia (Approved in March 2014)
`Newly added in Phase Ill in the U.S.
`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)
`
`Out-licensed to Sunesis Pharmaceuticals Inc. for the
`worldwide territory in October 2003.
`AG-7352
`Phase Ill study ongoing in North America by Sunesis
`
`(Sunesis’ product code: SNS-595).
`Out-licensed to Celgene (former Pharmion) for the
`amrubicin
`U.S. and European territories in June 2005.
`Small cell lung cancer
`hydrochloride
`Phase Ill study completed in the U.S. and Europe by
`
`(CALSED®)
`Celgene.
`Out-licensed to Eisai for the worldwide territory,
`ranirestat
`excluding Japan, in September 2005.
`Diabetic neuropathy
`AS-3201
`PhaseII/lil study ongoing in the U.S., Canada and
`
`Europe by Eisai.
`
`Shinyaku.(Nippon Shinyaku’s product code: NS-986).
` Out-licensed to Chelsea Therapeutics for the
` Neurogenic orthostatic
`
`droxidopa
`(DOPS*)
`
`hypotension,
`intradialytic
`hypotension,
`Fibromyalgia
`
`DSP-3025
`
`Bronchial asthma,
`Allergic rhinitis
`
`lurasidone
`hydrochloride
`(SM-13496)
`
`Schizophrenia
`Bipolar disorder
`
`SMP-986
`
`Nocturia
`
`worldwide territory, excluding Japan, China, Korea
`and Taiwan in May 2006.
`NDA submitted in the U.S. by Chelsea for neurogenic
`orthostatic hypotension in September 2011.
`Complete Response Letter received from FDAin
`March 2012. Chelsea resubmitted to FDA in July
`2013 and obtained the approval in February 2014..
`PhaseII study of fibromyalgia and phase II study of
`intradialytic hypotension completed by Chelsea.
`
`Entered into a development and marketing
`agreement in March 2005. AstraZeneca has the
`right for the worldwide territory, excluding Japan,
`China, Korea and Taiwan.
`Phase || study as a collunarium was completed in
`Europe, while a Phase | 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., Lid. for rights
`in Japan to develop and commercialize in March
`2013.
`Phase|| study ongoing in Japan by Nippon
`
`[Main revisions since the 3Q announcement of January 2014]
`
`Droxidopa (DOPS®)
`
`Lurasidone hydrochloride (SM-13496)
`
`for neurogenic
`approval
`Chelsea obtained the
`orthostatic hypotension in
`the U.S.
`in February
`2014.
`Takeda Pharmaceutical obtained the approval for
`schizophrenia in Europe in March 2014.
`
`- supplementary15 -
`
`16
`
`LATUDA03177036
`
`16
`
`

`

`VIIL Profile of Major Products under Development (As of May 8, 2014)
`
`APTIOM® (eslicarbazepine acetate) Epilepsy
`In-licensed from BIAL Portela & C*, S.A
`Sunovion obtained the approval of APTION® for
`A novel voltage-gated sodium channel inhibitor.
`usé 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.
`Developmentstage:
`
`Epilepsy (adjunctive therapy): Submitted in Canada
`Epilepsy (monotherapy):
`Phase lilin the U.S.
`
`LATUDA® (lurasidone 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-HT2, and serotonin 5-HT; receptors where it has antagonist
`effects.
`In addition, LATUDA is a partial agonist at the serotonin 5-HT,, receptor and has no
`appreciable affinity for histamine or muscarinic receptors.
`In the clinical studies supporting the U.S. FDA approval, the efficacy of LATUDAfor the treatment of
`
`schizophrenia was established in four, short-term (6-week), placebo-conirolled clinical studies in adult
`patients. In these studies, LATUDA demonstrated significantly greater improvement versus placebo.
`
`A total of five shori-term placebo controlled clinical studies contributed to the understanding of the
`tolerability and safety profile of LATUDA. LATUDA was approvedfor 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 2074. In
`addition, LATUDA was approved in Australia in March 2014.
`For the treatment of bipolar | depression, LATUDA was approved as the first atypical antipsychotic
`indicated for the treatment of bipolar | 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.
`
`Developmentstage:
`Schizophrenia:
`
`Approved in March 2014 and preparing for launch in Europe and
`Ausiralia
`
`Bipolar | depression:
`
`Bipolar maintenance:
`MDD with mixed features:
`
`Submitted in Taiwan by Standard Chem. & Pharm.
`Phase Ill in Japan and China
`
`PhaseIll in Japan
`an MAA in Europe
`submit
`to
`In
`addition, plans
`Pharmaceutical.
`(Phaseiil in Europe)
`Phase Ill in the U.S., Europe and Japan, etc.
`PhaseIll in the U.S. and Europe, etc.
`
`by Takeda
`
`- supplementary16 -
`
`17
`
`LATUDA03177037
`
`17
`
`

`

`ranirestat (AS-3201)
`- Developed in-house
`AS-3201 is expected to alleviate diabetic neuropathy, a complication of diabetes, by inhibiting aldose
`
`Diabetic neuropathy
`
`that causes diabetic
`reductase and thereby inhibiting the accumulation of intracellular sorbitol
`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 || / Ill studies in the U.S., Canada and Europe.
`Development stage: Phase Ill 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 CSC 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:
`
`Phase Ill in the U.S., Canada and Japan, etc.
`Colorectal cancer (monotherapy):
`Gastric cancer (combination therapy with paclitaxel): Phase Illin the U.S.
`Colorectal cancer (combination therapy with cetuximab, panitumumabor capecitabine):
`PhaseIl inthe U.S. and Canada
`
`Phase I/ll in the U.S. and Canada
`Solid cancer (combination therapy with paclitaxel):
`Gastric cancer (combination therapy with paclitaxel): Phase lin Japan
`Gastrointestinal cancer (combination therapy with FOLFOX', FOLFOX™ and bevacizumab, CAPOX®”,
`FOLFIRI®, FOLFIRI® and bevacizumab, or regorafenib):
`Phase| in the U.S. and Canada
`*{ FOLFOX: Combination therapy with fluorouracil, leucovorin, oxaliplatin
`*2 CAPOX: Combination therapy with capecitabine, oxaliplatin
`*3 FOLFIRI: Combination therapy with fluorouracil, leucovorin irinotecan
`
`EPI-743
`-
`
`Leigh syndrome
`In-licensed 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 II/Ill in Japan
`
`Nonalcoholic steatohepatitis (NASH), Primary biliary cirrhosis (PBC)
`DSP-1747
`-
`In-licensed from Intercept Pharmaceuticals Inc. (Intercept’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 Il in Japan for NASH. Phase li for PBC is under consideration.
`
`- supplementary17 -
`
`18
`
`LATUDA03177038
`
`18
`
`

`

`IBS with constipation, Chronic idiopathic constipation
`DSP-6952
`* Developed in-house
`DSP-6952is a high affinity serotonin-4 receptor partial agonist with enterokinetic effect. DSP-6952is
`expected to be effective for IBS with constipation and chronic idiopathic constipation by increasing
`
`complete spontaneous bowel movement.
`Development stage: Phase II in Japan
`
`Chronic obstructive pulmonary disease (COPD)
`glycopyrrolate bromide (SUN-101)
`- 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 PARI 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 Il in the U.S.
`
`Attention-deficit hyperactivity disorder (ADHD)
`SEP-225289
`* Developed in-house (Sunovion Pharmaceuticals Inc.)
`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 ofits ability to maintain a stable concentration in blood levels all day,
`effective over the course of the day.
`Development stage: Phase Il in the U.S.
`
`it is expected to be
`
`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. WT4869 is expected to treat patients with various types of hematologic and solid
`cancers that overexpress WT1, by the induction of WT1-specific cytotoxic T-lymphocytes.
`
`Developmentstage:
`Myelodysplastic syndromes (MDS):——PhaseI/Il in Japan
`Solid cancer:
`Phase| in Japan
`
`Bronchial asthma, Allergic rhinitis
`DSP-3025
`* Developed in-house
`DSP-3025 is an immune response modifier with agonistic activity against Toll-like receptor 7 (TLR7).
`it
`is expected to become a therapeutic agent providing long-term disease remission in bronchial
`asthma and allergic rhinitis.
`
`A series of promising compounds wasidentified from drug discovery research for a therapeutic agent
`with a novel mechanism of action against allergic disorders. With this as a turning point, we started
`a research collaboration with AstraZeneca in 2004 and discovered a drug candidate as an outcome
`based on this research collab