第一三共（4568） – Reference Data

TSE:4568Reference Data(Consolidated Financial Results for Q4 FY2021)April 27, 2022Daiichi Sankyo Co., Ltd.https://www.daiichisankyo.comContentsConsolidated Statement of Profit or LossSheet to adjust Operating Profit to Core Operating ProfitRevenue of Global ProductsRevenue by Business Units and ProductsConsolidated Statement of Financial PositionConsolidated Statement of Cash FlowsNumber of EmployeesCapital Expenditure, Depreciation and Amortization1.2.3.4.5.6.7.8.9.Summary of Product Outlines10. Other Financial Indicators11. Quarterly Data12. Historical Data13. Major R&D Pipeline (Innovative pharmaceuticals)P1P2P3P5P8P10P11P11P11P12P13P18P22FY2020FY2021FY2022to revenue Resultsto revenue Results (vs. Forecast (%))YoY YoY (%)to revenue ForecastYoYYoY (%)Cost of sales※135.1%337.833.3%348.0105.5%10.3 +3.0%28.5%328.0-20.0-5.8%100.0%962.5100.0% 1,044.9101.4%82.4 +8.6%100.0% 1,150.0105.1+10.1%Gross Profit64.9%624.866.7%696.999.6%72.1 +11.5%71.5%822.0125.1+18.0%318.5227.433.7%24.3%352.1254.199.2%99.7%33.7 +10.6%26.7 +11.7%35.7%26.7%410.0307.057.952.9+16.4%+20.8%8.7%90.6100.7%11.8 +14.9%9.1%105.014.4+15.9%—3.9-21.5Operating Profit6.6%7.0%73.079.4%9.2 +14.5%9.1%105.032.0+43.8%Forex impact: +28.7(USD: +12.7, EUR: +7.2, ASCA: +8.7)Forex impact: +3.8(USD: +4.0, EUR: -1.5, ASCA: +1.3)Forex impact: +11.7(USD: +5.9, EUR: +2.4, ASCA: +3.3)Forex impact: +9.2(USD: +6.9, EUR: +2.0, ASCA: +0.3)Forex impact: +3.9(USD: -4.2, EUR: +4.4, ASCA: +3.7)- Recognition of financial income dueto decrease in contingentconsideration of quizartinibacquisition -4.7 (FY2020)- Deterioration in forex gains/losses-1.17.0%73.579.9%-0.6 -0.8%9.1%105.031.5+42.8%6.4%6.4%67.0104.6%-8.9 -11.7%67.0104.6%-9.0 -11.8%7.2%7.2%83.016.0+23.9%83.016.0+23.9%1. Consolidated Statement of Profit or LossJPY BnRevenueSG&A expenses※1R&D expenses※1Core Operating ProfitTemporary income※2Temporary expenses※2Financial income/expensesShare of profit or loss of investmentsaccounted for using the equity methodProfit before taxIncome taxesProfit for the yearProfit attributable to owners of the CompanyTax rateOverseas sales ratioCurrency Rate (Average)USD/JPYEUR/JPY33.1%23.6%8.2%7.7%7.9%7.9%78.90.615.663.810.20.274.1-1.775.876.0-2.3%41.7%106.06123.703.45.9-9.8-0.08.23.921.50.40.16.58.9%46.6%112.38130.56Currency Rate (Average)130.00140.00Annual impact of one yen changeForecastUSDEURRevenueOperating Profit2.5 JPY Bn 1.2 JPY Bn-0.5 JPY Bn 0.3 JPY Bn*This report is not subject to audit procedures.※1 Temporary income and expenses are excluded for cost of sales, SG&A expenses and R&D expenses※2 See page 2 for the definition of temporary income and expenses and the adjustment of operating profit and core operating profit1＜Major Temporary income and Temporary expenses＞*1 Vaccine business loss compensation (15.0)2. Sheet to adjust Operating Profit to Core Operating ProfitOperating Profit (full)63.8FY2020 ResultsJPY BnRevenueCost of salesSG&A expensesR&D expensesCore Operating ProfitTemporary income(Cost of sales)(SG&A expenses)(R&D expenses)Temporary expenses(Cost of sales)(SG&A expenses)(R&D expenses)FY2021 ResultsJPY BnRevenueCost of salesSG&A expensesR&D expensesCore Operating ProfitTemporary income(Cost of sales)(SG&A expenses)(R&D expenses)Temporary expenses(Cost of sales)(SG&A expenses)(R&D expenses)OperatingProfit (full) gains and lossesrelated to sale of fixedassetsgains and lossesrelated to restructuringAdjustmentgains and lossesrelated to impairment,gains and losses related toloss compensation,reconciliationOthersOperatingProfit (Core)962.5338.3333.1227.463.81,044.9353.3358.3260.273.0-0.00.0-0.1-0.10.10.00.00.10.00.0-0.0-3.8-0.1-3.93.90.00.10.00.00.00.0-3.8 *1——–0.51.01.6-0.5 *31.0 *3-0.50.00.00.6-0.60.50.00.0-5.30.05.210.4-5.3 *20.05.2 *3-15.015.015.015.0 *1————0.4-0.40.40.4——-9.59.50.00.09.59.5 *4962.5337.8318.5227.478.90.60.00.40.115.60.515.00.063.81,044.9348.0352.1254.190.63.90.03.80.121.55.310.06.273.0OperatingProfit (full) gains and lossesrelated to sale of fixedassetsgains and lossesrelated to restructuringgains and lossesrelated to impairment,gains and losses related toloss compensation,reconciliationOthersOperatingProfit (Core)AdjustmentOperating Profit (full)73.0As an indicator of ordinary profitability, “core operating profit” which excludes temporary income and expenses from operating income is disclosed. Gains and losses related to: sale of fixed assets, restructuring(excluding the sales of pipeline and launched products), impairment, loss compensation, reconciliation, and other non-temporary and material gains and losses are included in the “temporary income and expenses”.1.610.4*4 Environmental expenditures related to former Yasugawa plant (9.5) ＜Major Temporary income and Temporary expenses＞*1 Gains related to sale of fixed assets of Osaka logistics center (2.1)*2 Losses rerated to impairment of Intangible assets of Zelboraf (2.8) Losses rerated to impairment of Intangible assets of Turalio (2.2)*3 Losses related to closure of PLX (5.8)23. Revenue of Global Products (1)FY2021FY2022FY2020ResultsResults(vs. Forecast (%))YoYYoY (%)ForecastYoYYoY (%)JPY BnTrastuzumab deruxtecananti-cancer agent(HER2-directed antibody drug conjugate)Product sales　*Incl. Gross profit share in AstraZeneca territoryEnhertu (JPN)Enhertu (US)Enhertu (EU)Enhertu (ASCA: Asia, South and Central America)Upfront paymentRegulatory milestone paymentUS HER2+ Breast Cancer 3LEU HER2+ Breast Cancer 3LUS HER2+ Gastric Cancer 2L/3LUS HER2+ Breast Cancer 2LEU HER2+ Breast Cancer 2LUS HER2-low Breast Cancer (post chemo)EU HER2+ Gastric Cancer 2LUS HER2+ or HER2 Mutant NSCLC 2LQuid related payment*43.530.14.425.70.0-9.83.50.91.01.6——3.93.9(100.0%)-1.3-37.2%18.3+824.4%80.865.49.645.49.01.49.82.20.90.50.8—–(105.5%)37.4+85.9%(106.9%)35.3+117.1%(95.6%)5.2+119.5%(103.5%)19.7+76.4%(126.8%)(100.0%)(100.0%)(100.0%)(100.0%)——9.01.4——–0.5-0.8-50.0%-50.0%———-159.9128.416.083.123.06.39.820.60.90.50.83.42.66.91.24.31.16.96.979.163.06.437.714.0+97.8%+96.4%+67.4%+83.0%+154.7%4.9+355.8%————-3.42.66.91.24.30.90.9*Payment which shall be paid by AstraZeneca to Daiichi Sankyo if both parties do not enter into potential licensing opportunity (Granting Daiichi Sankyo rights to develop or commercialize AstraZeneca’s proprietary products, programs or technologies)Datopotamab deruxtecanUpfront paymentanti-cancer agent(TROP2-directed antibody drug conjugate)6.16.1(100.0%)(100.0%)2.12.1+53.7%+53.7%+14.1%+14.1%3.4(100.0%)3.4-2.3-66.7%33. Revenue of Global Products (2)FY2020FY2021FY2022Edoxabananticoagulant165.9205.6(101.4%)JPY BnLixiana (JPN)Savaysa (US)Lixiana (EU)ResultsResults(vs. Forecast (%))YoYYoY (%)ForecastYoYYoY (%)77.43.076.78.9(100.6%)(100.8%)(101.4%)92.51.996.914.339.715.1-1.120.2+23.9%+19.5%-35.4%+26.4%237.7104.32.4112.118.832.111.80.515.24.5+15.6%+12.8%+26.4%+15.7%+31.8%Edoxaban (ASCA: Asia, South and Central America)(106.5%)5.4+61.2%44. Revenue by Business Units and Products (1)FY2021FY2022FY2020ResultsResults(vs. Forecast (%))YoYYoY (%)ForecastYoYYoY (%)JPY BnJapan Business UnitLixianaNexiumPraliaTarligeTeneliaRanmarkLoxoninVimpatCanaliaEfientEnhertuRezaltasInavirEmgalityanticoagulantulcer treatmenttreatment for osteoporosis/inhibitor of the progression of bone erosionassociated with rheumatoid arthritispain treatment type 2 diabetes mellitus treatmenttreatment for bone complications caused by bonemetastases from tumorsanti-inflammatory analgesicanti-epileptic agenttype 2 diabetes mellitus treatmentantiplatelet agentanti-cancer agent(HER2-directed antibody drug conjugate)antihypertensive agentanti-influenza agentprophylaxis of migraine attacks489.1489.5(100.1%)0.4+0.1%(100.6%)15.1+19.5%(100.0%)-38.2-49.1%92.539.637.930.123.720.422.218.316.816.79.612.01.34.682.814.8(102.7%)(100.2%)(99.4%)(102.5%)(97.7%)(100.1%)(99.6%)(100.4%)(95.6%)(97.6%)(100.0%)—+9.4%+46.6%-2.4%+5.6%-8.2%+25.6%+8.8%+18.9%+119.5%-8.6%-63.1%-3.39.6-0.61.1-2.03.71.42.75.2-1.1-2.34.611.4-3.777.477.834.620.624.219.324.214.515.414.14.413.13.6-71.418.567.2483.8104.3-36.038.223.021.017.521.918.823.516.08.48.713.1-5.711.8-39.6-1.98.1-0.60.6-4.73.62.06.86.4-3.67.38.5—1.2%+12.8%–5.0%+26.8%-2.6%+2.9%-21.0%+19.5%+11.9%+40.7%+67.4%-30.2%+547.5%+182.8%–Daiichi Sankyo Espha productsVaccines business+15.9%not disclosed-20.2%not disclosedDaiichi Sankyo Healthcare Unit64.7(93.2%)-2.5-3.7%69.42.2+7.3%54. Revenue by Business Units and Products (2)FY2021FY2022FY2020ResultsResults(vs. Forecast (%))YoYYoY (%)ForecastYoYYoY (%)JPY BnOncology Business Unit*1EnhertuEnhertu (US)Enhertu (EU)anti-cancer agent(HER2-directed antibody drug conjugate)TURALIOanti-cancer agent*1 Oncology products revenue in EU will be booked in Oncology business unit (OBU) from FY2021.American Regent UnitInjectaferVenofertreatment for iron deficiency anemiatreatment for iron deficiency anemiaEU Specialty Business Unit*2LixianaanticoagulantNilemdo/Nustendicholesterol-lowering agentOlmesartanantihypertensive agent*2 EU speciality business unit (EUSBU) from FY2021. Oncology product revenue will be booked in OBU.ASCA Business UnitDaiichi Sankyo ChinaDaiichi Sankyo KoreaDaiichi Sankyo Brasil FarmacêuticaDaiichi Sankyo TaiwanDaiichi Sankyo ThailandDaiichi Sankyo Hong Kong111.7128.2(101.8%)47.425.725.70.01.8121.744.128.876.70.621.599.745.619.610.58.32.30.769.654.445.49.02.8149.553.133.896.93.120.353.323.213.710.02.21.7(103.2%)22.2+46.9%(106.8%)28.7+111.5%(103.5%)19.7+76.4%(101.5%)27.7+22.8%(126.8%)(104.0%)(99.8%)(105.0%)(101.4%)9.01.08.94.9-+53.7%+20.2%+17.1%16.620.2+14.9%+26.4%(109.5%)2.6+448.2%(101.6%)-1.2-5.6%(105.6%)(98.5%)(107.1%)(114.6%)7.73.63.21.7+16.9%+18.4%+30.5%+20.4%(102.2%)-0.1-4.2%-1.0+151.6%110.0106.183.123.03.9175.863.137.4139.5112.17.116.161.023.017.29.92.34.440.451.737.714.0+58.1%+94.9%+83.0%+154.7%1.1+40.7%26.310.03.611.215.24.0-4.27.7-0.13.6-0.10.12.7+17.6%+18.8%+10.8%+8.7%+15.7%+127.0%-20.8%+14.4%-0.5%+26.0%-1.1%+4.9%+165.8%114.1(104.4%)14.5+14.5%126.312.1+10.6%64. Revenue by Business Units and Products (3)FY2020FY2021FY2022[Reference] Revenue in Local CurrencyResultsResults(vs. Forecast (%))YoYYoY (%)ForecastYoYYoY (%)TURALIOanti-cancer agent*1 Oncology products revenue in EU will be booked in Oncology business unit (OBU) from FY2021.USD MnOncology Business Unit*1EnhertuEnhertu (US)Enhertu (EU)USD MnAmerican Regent UnitInjectaferVenoferEUR MnEU Specialty Business Unit*2anti-cancer agent(HER2-directed antibody drug conjugate)treatment for iron deficiency anemiatreatment for iron deficiency anemiaLixianaanticoagulantNilemdo/Nustendicholesterol-lowering agentOlmesartanantihypertensive agent*2 EU speciality business unit (EUSBU) from FY2021. Oncology product revenue will be booked in OBU.4472432430.1171,1484162729036205174(100.6%)(104.1%)(100.9%)(123.6%)(101.4%)(98.9%)(97.3%)(102.4%)173242161808+38.7%+99.7%+66.5%-+45.0%182+15.9%5629+13.5%+10.5%(99.8%)(99.4%)80122+8.8%+19.7%(107.3%)19+419.4%61948440480251,33047230098274224155846816639177301,352485288996801511152273322359752213-13145827+36.6%+68.5%+58.2%+120.2%+21.6%+1.7%+2.7%-4.3%+1.4%+7.9%+111.7%(99.6%)-18-10.6%-41-26.1%75. Consolidated Statement of Financial PositionAssetsCurrent assetsCash and cash equivalentsTrade and other receivablesOther financial assetsInventoriesOther current assetsTotal current assetsNon-current assetsProperty,plant and equipmentGoodwillIntangible assetsOther financial assetsDeferred tax assetsOther non-current assetsTotal non-current assets＊Liquidity on handDebt with interestNet CashInvestments accounted for using the equity methodMar. 2021Mar. 2022vs. Mar. 2021JPY Bn1,268.41,345.3380.5232.0444.4200.910.6265.377.7172.81.4140.0128.531.0816.8827.2226.2601.0662.5266.7181.4217.916.8304.183.6163.91.4131.5138.253.5876.1842.9213.6629.3281.934.6-263.017.06.276.938.85.8-8.9-0.0-8.59.622.559.415.7-12.628.3Total assets2,085.22,221.4136.2Acquisition +75.1, Depreciation -33.0, Impairment Loss -4.7 Acquisition +13.9, Amortization -25.0, Impairment Loss -5.8Investment securities -7.7Contribution for equipment +11.18LiabilitiesCurrent liabilitiesTrade and other payablesBonds and borrowingsOther financial liabilitiesIncome taxes payableProvisionsOther current liabilitiesTotal current liabilitiesNon-current liabilitiesBonds and borrowingsOther financial liabilitiesPost employment benefit liabilitiesProvisionsDeferred tax liabilitiesOther non-current liabilitiesTotal non-current liabilitiesTotal liabilitiesEquityEquity attributable to owners of the CompanyShare capitalCapital surplusTreasury sharesOther components of equityRetained earningsTotal equity attributable to owners of the CompanyTotal equityTotal liabilities and equityMar. 2021Mar. 2022vs. Mar. 2021JPY Bn297.520.49.46.16.114.2353.6163.437.03.98.717.5228.9459.6813.150.094.5-261.3111.51,277.31,272.11,272.12,085.220.410.86.96.825.6395.342.62.618.312.4256.2475.3870.550.0–37.5168.11,170.21,350.91,350.92,221.40.01.40.80.711.441.75.6-1.39.5-5.127.315.757.4–94.5223.856.7-107.178.878.8136.2324.827.3Vaccine business loss compensation -15.0Repayment of syndicated loan -20.0Transfer of syndicated loan +20.0 (Transfer from Non-current liabilities “Bonds and borrowings”)143.1-20.4Transfer of syndicated lone -20.0(Transfer to current liabilities “Bonds and borrowings”)Deferred revenue for datopotamab deruxtecan +29.5 (Strategic collaboration upfront payment +35.6, Profit recording -6.1)Deferred revenue for trastuzumab deruxtecan +0.6(Strategic collaboration upfront payment -9.8, Regulatory milestone payment +10.5)Acquisition of treasury shares -94.5Acquisition of treasury shares +223.0Profit for the period +67.0, Payment of dividends -51.7,Acquisition of treasury shares -128.596. Consolidated Statement of Cash FlowsCash flows from operating activitiesProfit before taxDepreciation and amortizationOthers, netIncome taxes paidCash flows from investing activities(Increase) decrease in receivables and payables-5.8-112.7Net cash flows from operating activities139.2-53.0Net (increase) decrease in time deposits and securities283.3254.1Net cash flows from investing activities212.3251.6(Acquisition of) proceeds from sales of fixed assetsNet (increase) decrease in investment securitiesOthers, netCash flows from financing activitiesNet (increase) decrease in borrowingsRepayments of bondsPurchase of treasury sharesDividends paidOthers, netNet cash flows from financing activitiesNet increase (decrease) in cash and cash equivalentsCash and cash equivalents at the beginning of the periodEffect of exchange rate changes on cash and cash equivalentsCash and cash equivalents at the end of the periodJPY BnFY2020FY2021YoY74.157.4107.0-21.7-24.5192.229.2-64.1-0.2-4.2-39.2-20.4-20.0-100.2-48.9-12.9-202.4-49.5424.25.8380.573.558.235.8-22.6-70.80.1-0.2-20.4–51.7-14.1-0.60.957.61.9-6.80.34.0-0.020.0-2.8-1.2-0.0100.2-86.2116.2265.3314.8380.5-43.616.610.8662.5281.9*Free cash flows (Cash flows from operating activities and investing activities)153.0351.6198.6107. Number of EmployeesDec. 2020Dec. 2021ConsolidatedJapanNorth AmericaEuropeOthers8. Capital Expenditure, Depreciation and AmortizationJPY BnCapital expenditureDepreciation and amortizationProperty, plant and equipmentIntangible assets9. Other Financial IndicatorsResults16,0338,9792,6022,1372,315FY2020Results40.157.431.326.1FY2020ResultsResults16,4589,1352,7062,2792,338FY2021Results56.258.233.225.1FY2021ResultsAverage equity attributable to owners of the Company for the period1,288.9JPY Bn1,311.5JPY BnProfit attributable to owners of the CompanyDividendsReturn on Equity (ROE)Dividend on Equity (DOE) 76.052.15.94.0JPY BnJPY Bn%%67.051.85.13.9JPY BnJPY Bn%%FY2022Forecast52.058.0–1110. Summary of Product OutlinesJapan Business UnitBrand NameGeneric NameTherapeutic CategoryLaunchedOriginMarketing AllianceType of AllianceanticoagulantDaiichi SankyoAstraZenecaAstraZenecaCo-promotion (DS: Sales)type 2 diabetes mellitus treatmentMitsubishi TanabeMitsubishi TanabeCo-promotion (DS: Sales)Loxonin PoulticeLoxonin TapeLoxonin Gelloxoprofenanti-inflammatory analgesicedoxabanesomeprazoledenosumabmirogabalinteneligliptindenosumablacosamideprasugreltrastuzumab deruxtecanolmesartan / azelnidipinelaninamivirulcer treatmenttreatment for osteoporosis/inhibitor of the progression of bone erosionassociated with rheumatoid arthritispain treatment treatment for bone complications caused bybone metastases from tumorsantiplatelet agentanti-cancer agent(HER2-directed antibody drug conjugate)antihypertensive agentanti-influenza agentteneligliptin / canagliflozintype 2 diabetes mellitus treatmentMitsubishi TanabeMitsubishi TanabeCo-promotion (DS: Sales)anti-epileptic agentUCBUCBCo-promotion (DS: Sales)trastuzumab deruxtecanpexidartinibanti-cancer agent(HER2-directed antibody drug conjugate)anti-cancer agentDaiichi SankyoAstraZenecaCo-promotion (DS: Sales)ferric carboxymaltose injectiontreatment for iron deficiency anemiaVifor PharmaDaiichi Sankyo, Inc.Promotion (Daiichi Sankyo, Inc.)iron sucrose injectiontreatment for iron deficiency anemiaVifor PharmaFreseniusCo-marketingNilemdo/Nustendibempedoic acid, bempedoic acid / ezetimibecholesterol-lowering agentDaiichi SankyoEsperionedoxabananticoagulantDaiichi SankyoMerck (MSD)Co-marketingolmesartanolmesartan / hydrochlorothiazideolmesartan / amlodipineolmesartan / amlodipine / hydrochlorothiazideantihypertensive agentDaiichi SankyoCo-marketingMenariniPfizerLixianaNexiumPraliaTarligeTeneliaRanmarkLoxoninVimpatCanaliaEfientEnhertuRezaltasInavirEnhertuTuralioInjectaferVenoferOncology Business UnitAmerican Regent UnitEU Specialty Business UnitLixianaOlmesartanOlmetecOlmetec PlusSevikarSevikar HCTAmgenDaiichi SankyoAmgenDaiichi SankyoLead ChemicalLead ChemicalDaiichi SankyoDaiichi SankyoUbe IndustriesDaiichi SankyoDaiichi SankyoDaiichi SankyoDaiichi Sankyo2011201120132019201220121986200620082010201620172014202020102010202020192013200020152020200220052009201012<11. Quarterly Data>1. Consolidated Statement of Profit or LossFY2020Q1ResultsFY2020Q2ResultsFY2020Q3ResultsFY2020Q4ResultsFY2020to revenueResultsFY2021Q1ResultsFY2021Q2ResultsFY2021Q3ResultsFY2021Q4ResultsFY2021to revenue Results YoY YoY (%)JPY BnRevenueCost of salesGross ProfitSG&A expensesR&D expensesCore Operating ProfitTemporary incomeTemporary expensesOperating ProfitFinancial income/expensesShare of profit or loss of investmentsaccounted for using the equity methodProfit before taxIncome taxesProfit for the yearProfit attributable to owners of the Company236.982.2154.771.848.934.10.10.034.17.20.041.49.631.831.9243.286.4156.976.855.724.30.00.024.31.20.025.65.819.819.8258.687.8170.880.759.131.00.00.031.01.50.032.68.524.124.1223.7100.0%962.581.335.1%337.8142.464.9%624.889.263.7-10.50.415.6-25.70.10.1-25.4-25.60.20.233.1%23.6%8.2%6.6%7.7%7.9%7.9%318.5227.478.90.615.663.810.20.274.1-1.775.876.0264.185.2178.981.254.043.72.10.045.81.3-0.047.111.835.235.2265.987.4178.584.555.039.00.00.139.0-0.10.038.911.627.227.2281.090.6190.490.060.140.30.01.339.00.90.039.98.131.931.9233.9100.0% 1,044.982.4+8.6%84.833.3%348.010.3+3.0%149.166.7%696.972.1 +11.5%33.7%24.3%352.1254.133.7 +10.6%26.7 +11.7%8.7%90.611.8 +14.9%7.0%73.09.2 +14.5%3.921.53.45.90.40.1-9.8-0.07.0%73.5-0.6-0.8%6.58.2 -483.6%6.4%67.0-8.9 -11.7%6.4%67.0-9.0 -11.8%96.485.0-32.41.820.1-50.7-1.70.1-52.4-25.0-27.3-27.3-51.3%11.6213.04Tax rateOverseas sales ratio23.1%38.6%22.8%42.3%26.1%40.1%-46.4%-2.3%41.7%25.2%44.7%29.9%45.1%20.2%45.7%Currency Rate (YTD Average)USD/JPYEUR/JPY107.62118.47106.92121.29106.11122.37106.06123.70106.06123.70109.49131.95110.11129.83113.71130.078.9%46.6%112.38130.5613<11. Quarterly Data>2. Revenue of Global ProductsJPY BnTrastuzumab deruxtecanProduct salesEnhertu(JPN)Enhertu (US)Enhertu (EU)Enhertu (ASCA: Asia, South and Central America)Upfront paymentRegulatory milestone paymentUS HER2+ Breast Cancer 3LEU HER2+ Breast Cancer 3LUS HER2+ Gastric Cancer 2L/3LUS HER2+ Breast Cancer 2LEU HER2+ Breast Cancer 2LUS HER2-low Breast Cancer (post chemo)EU HER2+ Gastric Cancer 2LUS HER2+ or HER2 Mutant NSCLC 2LQUID related paymentDatopotamab deruxtecanUpfront paymentEdoxabanLixiana (JPN)Savaysa (US)Lixiana (EU)Edoxaban (ASCA: Asia, South and Central America)FY2020 Q1FY2020 Q2FY2020 Q3FY2020 Q4FY2020FY2021 Q1FY2021 Q2FY2021 Q3FY2021 Q4FY2021ResultsResultsResultsResultsResultsResultsResultsResultsResultsResults7.95.20.25.02.50.20.2————38.719.80.616.41.99.87.10.86.32.50.20.2———-1.01.040.418.51.118.62.211.18.41.76.72.50.20.2———-1.51.545.621.50.721.02.314.79.41.77.70.0-2.52.90.21.01.6——1.51.541.217.60.620.72.443.530.14.425.70.0-9.83.50.91.01.6——3.93.9165.977.43.076.78.916.013.02.29.61.2-2.50.60.20.10.2——1.51.549.522.90.523.42.716.813.82.210.11.4-2.50.60.20.10.2——1.61.649.721.90.523.73.622.916.82.611.92.3-2.50.60.20.10.2—–3.11.51.557.025.60.427.23.825.121.92.613.84.11.42.50.60.20.10.2—–0.31.51.549.422.00.522.64.280.865.49.645.49.01.49.82.20.90.50.8—–3.46.16.1205.692.51.996.914.3143. Revenue by Business Units and Products (1)FY2020 Q1FY2020 Q2FY2020 Q3FY2020 Q4FY2020FY2021 Q1FY2021 Q2FY2021 Q3FY2021 Q4FY2021ResultsResultsResultsResultsResultsResultsResultsResultsResultsResultsJPY BnJapan Business UnitLixianaNexiumPraliaTarligeTeneliaRanmarkLoxoninVimpatCanaliaEfientEnhertuRezaltasInavirEmgalityDaiichi Sankyo Espha productsVaccines businessDaiichi Sankyo Healthcare Unit130.219.819.98.74.36.65.06.23.83.93.80.23.60.6-17.62.914.3119.918.519.18.34.95.94.76.13.43.73.30.83.20.7-16.77.818.7136.321.521.99.46.26.75.26.84.14.33.81.73.60.9-20.97.618.4102.717.617.08.25.25.14.45.13.33.53.11.72.81.4-16.30.215.7489.177.477.834.620.624.219.324.214.515.414.14.413.13.6-71.418.567.2129.122.919.79.27.16.45.15.84.54.34.12.23.30.30.920.01.415.4126.521.919.99.37.15.75.05.54.44.03.92.22.90.51.219.84.018.4138.125.6-0.010.38.76.55.56.35.14.74.72.63.30.21.324.212.315.995.822.0-0.09.27.35.14.84.64.33.84.02.62.40.31.218.8-2.915.0489.592.539.637.930.123.720.422.218.316.816.79.612.01.382.814.864.7153. Revenue by Business Units and Products (2)FY2020 Q1FY2020 Q2FY2020 Q3FY2020 Q4FY2020FY2021 Q1FY2021 Q2FY2021 Q3FY2021 Q4FY2021ResultsResultsResultsResultsResultsResultsResultsResultsResultsResults*1 Oncology products revenue in EU will be booked in Oncology business unit (OBU) from FY2021.*2 EU speciality business unit (EUSBU) from FY2021. Oncology product revenue will be booked in OBU.JPY BnOncology Business Unit*1EnhertuEnhertu (US)Enhertu (EU)TuralioAmerican Regent UnitInjectaferVenoferEU Specialty Business Unit*2LixianaNilemdo/NustendiOlmesartanASCA Business UnitDaiichi Sankyo ChinaDaiichi Sankyo KoreaDaiichi Sankyo Brasil FarmacêuticaDaiichi Sankyo TaiwanDaiichi Sankyo ThailandDaiichi Sankyo Hong Kong11.65.05.0-0.326.59.46.927.716.4-5.222.58.64.42.92.10.60.212.06.36.3-0.532.511.57.726.618.6-5.825.811.45.02.62.00.70.111.86.76.7-0.532.111.37.528.621.00.15.226.112.94.92.72.10.70.112.07.77.70.00.530.711.96.728.720.70.45.325.212.75.22.32.10.30.247.425.725.70.01.8121.744.128.8111.776.70.621.599.745.619.610.58.32.30.714.510.89.61.20.639.114.97.932.723.40.75.626.511.85.83.32.30.50.316.611.610.11.40.737.914.18.630.923.70.94.728.613.76.13.22.30.50.118.114.211.92.30.738.713.48.834.327.20.64.627.913.05.93.62.20.50.420.417.913.84.10.833.810.78.530.322.60.95.431.214.85.33.63.30.60.969.654.445.49.02.8149.553.133.8128.296.93.120.3114.153.323.213.710.02.21.7163. Revenue by Business Units and Products (3)FY2020 Q1FY2020 Q2FY2020 Q3FY2020 Q4FY2020FY2021 Q1FY2021 Q2FY2021 Q3FY2021 Q4FY2021[Reference] Revenue in Local CurrencyResultsResultsResultsResultsResultsResultsResultsResultsResultsResults*1 Oncology products revenue in EU will be booked in Oncology business unit (OBU) from FY2021.USD MnOncology Business Unit*1EnhertuEnhertu (US)Enhertu (EU)TuralioUSD MnInjectaferVenoferAmerican Regent UnitEUR MnEU Specialty Business Unit*2LixianaNilemdo/NustendiOlmesartan1074646-32468864234139-441136060-530510972214150-471136464-430710872230169142113737305290113632251623414472432430171,1484162729036205174132998811635713672248177643150105921363441287823818273616012510520634011877263209536177155119367289917323217474161948440480251,3304723009827422415517Enhertu (ASCA: Asia, South and Central America)<12. Historical Data>1. Revenue of Global ProductsJPY BnTrastuzumab deruxtecanProduct salesEnhertu (JPN)Enhertu (US)Enhertu (EU)Upfront paymentRegulatory milestone paymentUS HER2+ Breast Cancer 3LEU HER2+ Breast Cancer 3LUS HER2+ Gastric Cancer 2L+3LDatopotamab deruxtecanUpfront paymentEdoxabanLixiana (JPN)Savaysa (US)Lixiana (EU)Other subsidiariesOlmesartanOlmetec (JPN)Rezaltas (JPN)Olmesartan (US)Olmesartan (EU)Other subsidiaries, export, etcPrasugrelEffient alliance revenue (US)Efient (EU)Efient (JPN)Other subsidiaries, export, etcFY2016FY2017FY2018FY2019FY2020ResultsResultsResultsResultsResults————-37.325.01.99.70.869.417.566.443.221.541.622.27.910.41.0————-77.145.32.227.02.644.616.821.333.533.532.810.78.012.81.30.10.1———–64.92.345.84.714.915.510.727.437.423.22.45.713.91.214.03.23.29.80.90.9——-83.02.661.76.811.714.69.824.640.118.10.52.514.01.2218.0149.7105.9100.843.530.14.425.70.0-9.83.50.91.01.63.93.977.43.076.78.991.89.213.18.621.539.417.30.31.614.11.3117.7154.0165.9182. Revenue by Business Units and Products (1)FY2016FY2017FY2018FY2019FY2020JPY BnJapan Business UnitResultsResultsResultsResultsResults540.0523.3533.5489.1LixianaNexiumPraliaTarligeTeneliaRanmarkLoxoninVimpatCanaliaEfientEnhertuRezaltasInavirDaiichi Sankyo Espha productsVaccines businessDaiichi Sankyo Healthcare Unit506.625.084.018.024.213.937.40.410.4—17.519.620.238.566.745.386.523.2-26.315.436.52.62.712.8-16.825.346.741.972.964.978.327.4-25.316.430.56.69.213.9-15.518.255.541.566.483.079.830.98.024.717.928.311.212.814.0-14.619.360.535.668.577.477.834.620.624.219.324.214.515.414.14.413.13.671.418.567.2192. Revenue by Business Units and Products (2)FY2016FY2017FY2018FY2019FY2020ResultsResultsResultsResultsResultsOncology Business Unit142.374.836.3JPY BnEnhertuEnhertu (US)Enhertu (EU)TuralioOlmesartanWelcholEffientSavaysaAmerican Regent UnitInjectaferVenoferEU Specialty Business UnitLixianaNilemdo/NustendiOlmesartanEfientASCA Business UnitDaiichi Sankyo ChinaDaiichi Sankyo KoreaDaiichi Sankyo Brasil FarmacêuticaDaiichi Sankyo TaiwanDaiichi Sankyo Thailand—-66.445.522.21.988.124.028.571.09.7-43.27.972.133.88.88.85.22.5—-21.333.910.72.2105.434.331.079.427.0-33.58.080.435.311.810.16.62.9—-10.713.42.42.3117.844.228.988.645.8-27.45.787.738.515.710.07.13.332.13.23.2–9.89.10.52.6130.851.831.095.561.7-24.62.598.346.017.211.57.63.347.425.725.70.01.88.65.00.33.0121.744.128.8111.776.70.621.51.699.745.619.610.58.32.3202. Revenue by Business Units and Products (3)FY2016FY2017FY2018FY2019FY2020[Reference] Revenue in Local CurrencyResultsResultsResultsResultsResultsUSD MnOncology Business UnitEnhertuEnhertu (US)Enhertu (EU)TuralioOlmesartanWelcholEffientSavaysaUSD MnAmerican Regent UnitInjectaferVenoferEUR MnEU Specialty Business UnitLixianaNilemdo/NustendiOlmesartanEfient1,312674327—-6124202051781222126359781-36367—-1923069620951310279613208-25862—-9712122211,062399261690357-213442953030–91844241,204477285789509-2032144724324301781473281,1484162729036205174132112. Major R&D Pipeline (Innovative Pharmaceuticals)As of Apr 2022◆ Explanation of DescriptionGeneric name/Project Code Number (mechanism of action)Detail on its mechanismStudy NamePopulationStudy DesignEvaluation ItemsRegion StatusPatients and target indications forthe studyStudy design schematic (randomize ornot, blinding or not, control group or not)SamplesizeTargetsamplesize・ Primary and secondary endpointsare listed・ Safety measures aresummarized as “safety”・ Pharmacokinetic indices aresummarized as “PK”Regionunderstudy (notconsistentwithregionunderdevelopment)・ Announcements as these trialsopen・ Scheduled time to achieve TLR(LPD if achieved)・ Schedule timing of submissionfor late-phase projects・ Application status, status ofobtaining various reviewpreference systems, etc.・ Phase of the study・ Study Name(if applicable)・ CTG registrationnumber・ JapicCTI/jRCTregistration number・ Partner, if applicable◆ List of AbbreviationsADA: ant-drug antibody; ADC: antibody drug conjugate; BMFI: brain metastases-free interval, CR: complete remission, CRL: complete response letter, DCR: disease control rate, DFS: disease-free survival, DOR: duration of response, DRFI: distant recurrence-free interval, EFS: event-free survival, FPD: first patient dosed, FSD: first subject dosed, IDFS: invasive disease-free survival,LPD: last patient dosed, NSCLC: non small cell lung cancer, ORR: overall response rate/objective response rate, OS: overall survival, pCR: pathological complete response, PFS: progression-freesurvival, PK: pharmacokinetics, SCLC: small cell lung cancer, TLR: top line results, TTR: time to response22Trastuzumab deruxtecan/DS-8201/T-DXd (HER2-directed ADC)Antibody-drug conjugate which is composed of a humanized monoclonal antibody specifically targeting HER2, one of the Epidermal Growth Factor Receptor (EGFR) family proteins, and acovalently linked drug (payload) via a cleavable linker. Payload is a potent and membrane permeable DNA topoisomerase I inhibitor which enables elimination of both target tumor cells and thesurrounding tumor cells. Drug-to-antibody ratio is approximately 8.Brand name: ENHERTU (JP/US/EU)Study NamePopulationEvaluation ItemsRegion StatusHER2 positive breast cancer, 3LStudy DesignSamplesize253 Randomized, open label・DS-8201Primary endpoint: ORRSecondary endpoint: ORR, DOR,PFS, OS, etc.JP/US/EU/AsiaFPD: Oct 2017TLR: May 2019Jan 2020: Launch (US)May 2020: Launch (JP)Feb 2021: Launch (EU)HER2 positive breast cancer, 3L600 Randomized, open label, active control・DS-8201・Physician’s choice (trastuzumab +capecitabine or lapatinib + capecitabine)Primary endpoint: PFSSecondary endpoint: OS, ORR,DOR, PFS, etc.JP/US/EU/AsiaFPD: Sep 2018TLR anticipated: FY2022 H1HER2 positive breast cancer, 2L500 Randomized, open label, active control・DS-8201・T-DM1Primary endpoint: PFSSecondary endpoint: OS, ORR,DOR, PFS, etc.JP/US/EU/AsiaFPD: Aug 2018TLR: Aug 2021◆ 3 ADCsPhase 2 (pivotal)DESTINY-Breast01NCT03248492JapicCTI-173693AstraZenecaPhase 3DESTINY-Breast02NCT03523585JapicCTI-184017AstraZenecaPhase 3DESTINY-Breast03NCT03529110JapicCTI-183976AstraZenecaDec 2021: Filing accepted (JP/EU)Jan 2022: Filing accepted (US)Mar 2022: Filing accepted (CN)Aug 2021: Real Time OncologyReview Designation (US)Sep 2021: Breakthrough TherapyDesignation (US)23Trastuzumab deruxtecan/DS-8201/T-DXd (HER2-directed ADC)Study NameStudy DesignPopulationPhase 3DESTINY-Breast04HER2 low breast cancer, postchemotherapySamplesize540 Randomized, open label, active control・DS-8201・Physician’s choice (capecitabine,eribulin, gemcitabine, paclitaxel or nab-paclitaxel)Evaluation ItemsRegion StatusPrimary endpoint: PFSSecondary endpoint: OS, ORR,DOR, etc.JP/US/EU/AsiaFPD: Dec 2018TLR: Feb 2022Filing anticipated: FY2022 H1Feb 2022: Real Time OncologyReview Designation (US)Apr 2022: Breakthrough TherapyDesignation (US)HER2 positive, with residualinvasive breast cancer followingneoadjuvant therapy・DS-8201・T-DM11,600 Randomized, open label, active controlPrimary endpoint: IDFSSecondary endpoint: DFS, OS,DRFI, BMFI, safety, PK, etc.JP/US/EU/AsiaFPD: Dec 2020Phase3DESTINY-Breast06HER2 low/HR positive breastcancer, chemotherapy naïve850 Randomized, open label, active control・DS-8201・Physician’s choice (capecitabine,paclitaxel or nab-paclitaxel)Primary endpoint: PFSSecondary endpoint: OS, PFS,ORR, DOR, safety, etc.JP/US/EU/AsiaFPD: Aug 2020HER2 positive breast cancerPart 1: 2L or laterPart 2: 1LPrimary endpoint: SafetySecondary endpoint: ORR, PFS,DOR, OS, PK, etc.US/EU/AsiaFPD: Jan 2021450 Open label, two-part (dose escalation,dose expansion)・DS-8201 + durvalumab・DS-8201 + pertuzumab・DS-8201 + paclitaxel・DS-8201 + durvalumab + paclitaxel･DS-8201 + tucatinib・DS-8201NCT03734029JapicCTI-184223AstraZenecaPhase 3DESTINY-Breast05NCT04622319jRCT2061200033AstraZenecaNCT04494425jRCT2061200028AstraZenecaPhase1b/2DESTINY-Breast07NCT04538742AstraZeneca24Trastuzumab deruxtecan/DS-8201/T-DXd (HER2-directed ADC)Study NamePopulationPhase1bDESTINY-Breast08HER2 low breast cancerchemotherapy naïve, postchemotherapyEvaluation ItemsRegion StatusPrimary endpoint: SafetySecondary endpoint: ORR, PFS,DOR, OS, PK, etc.US/EU/AsiaFPD: Jan 2021HER2 positive breast cancer, 1L1,134 Randomized, open label, active controlPrimary endpoint: PFSSecondary endpoint: OS, PFS,ORR, DOR, PK, safety, etc.JP/US/EU/AsiaFPD: Jun 2021Phase3DESTINY-Breast11HER2 positive breast cancer,neoadjuvantPrimary endpoint: pCRSecondary endpoint: EFS, IDFS,OSJP/US/EU/AsiaFPD: Nov 2021Study DesignSamplesize185 Open label, two-part (dose escalation,dose expansion)・DS-8201 + capecitabine・DS-8201 + durvalumab + paclitaxel・DS-8201 + capivasertib (AZD5363)・DS-8201 + anastrozole・DS-8201 + fulvestrant・DS-8201･DS-8201 + pertuzumab･Taxane + trastuzumab + pertuzumab624 Randomized, open label, active control・DS-8201・DS-8201, followed by paclitaxel +trastuzumab + pertuzumab・doxorubicin + cyclophosphamide,followed by paclitaxel + trastuzumab +pertuzumabTriple negative breast cancer200 Non-randomized, open label, combinationwith durvalumab・DS-8201 + durvalumabPrimary endpoint: SafetySecondary endpoint: ORR, PFS,DOR, OS, PK, etc.US/EU/AsiaFPD: May 2020HER2 overexpressing, gastric orgastroesophageal junctionadenocarcinoma, 3L* Umbrella study of durvalumab led byAstraZeneca220 Randomized, open label, active control・DS-8201・Physician’s choice (irinotecan orpaclitaxel)Primary endpoint: ORRSecondary endpoint: PFS, OS,DOR, DCR, TTF, ORR, PKJP/Asia FPD: Nov 2017TLR: Jan 2020Sep 2020: Approval (JP)Jan 2021: Approval (US)NCT04556773AstraZenecaPhase3DESTINY-Breast09NCT04784715jRCT2031210130AstraZenecaNCT05113251jRCT2041210097AstraZenecaPhase 1b/2BEGONIANCT03742102AstraZenecaPhase 2 (pivotal)DESTINY-Gastric01NCT03329690JapicCTI-173727AstraZenecaMar 2018: SAKIGAKE Designation(JP)May 2020: Breakthrough TherapyDesignation (US)May 2020: Orphan DrugDesignation (US)25Trastuzumab deruxtecan/DS-8201/T-DXd (HER2-directed ADC)Study NameStudy DesignPopulationSamplesize72Open label・DS-8201Evaluation ItemsRegion StatusPrimary endpoint: ORRSecondary endpoint: PFS, ORR,OS, DORUS/EU FPD: Dec 2019TLR: Jun 2021Nov 2021: Filing accepted (EU)Primary endpoint: Part 1: Safety,Part 2: ORRSecondary endpoint: ORR, safety,DOR, DCR, PFS, OS, PKJP/US/EU/AsiaFPD: Jun 2020Phase 2DESTINY-Gastric02NCT04014075AstraZenecaPhase 1b/2DESTINY-Gastric03NCT04379596jRCT2031200203AstraZenecaHER2 positive gastric orgastroesophageal junctionadenocarcinoma 2LPart 1HER2 positivegastric/gastroesophageal junctionand esophageal adenocarcinomaPart1: 2LPart 2: 1L255 Randomized, open labelPart 1・DS-8201 + fluorouracil・DS-8201 + capecitabine・DS-8201 + durvalumab・DS-8201 + oxaliplatin + fluorouracil・DS-8201 + capecitabine + oxaliplatin･DS-8201 + durvalumab + fluorouracil･DS-8201 + capecitabine + durvalumabPart 2・DS-8201・DS-8201 + oxaliplatin + fluorouracil orcapecitabine・DS-8201 + pembrolizumab + fluorouracilor capecitabine・DS-8201 + pembrolizumab・Trastuzumab + fluorouracil orcapecitabine + cisplatin or oxaliplatinPhase 3DESTINY-Gastric04HER2 positive gastric orgastroesophageal junctionadenocarcinoma, 2L490 Randomized, open label・DS-8201・Ramucirumab + paclitaxelPrimary endpoint: OSSecondary endpoint: PFS, ORR,DOR, DCR, safety, PK, ADA, etc.JP/EU/AsiaFPD: Jun 2021NCT04704934jRCT2031200369AstraZeneca26Trastuzumab deruxtecan/DS-8201/T-DXd (HER2-directed ADC)Study NameStudy DesignPopulationPhase 2DESTINY-Gastric06HER2 positive gastric orgastroesophageal junctionadenocarcinoma, 3LSamplesize100 Open label・DS-8201Evaluation ItemsRegion StatusPrimary endpoint: ORRSecondary endpoint: ORR, PFS,DCR, DOR, OS, Tumor sizechange, PK, ADAChinaFPD: Sep 2021Phase 2DESTINY-Lung01HER2 overexpressing or mutatedNSCLC, 2L or later170 Non-randomized, open label・DS-8201Primary endpoint: ORRSecondary endpoint: ORR, DOR,PFS, OSJP/US/EU FPD: May 2018TLR: Jun 2021HER2 mutated NSCLC, 2L or later150 Randomized, double blind・DS-8201: 6.4mg/kg・DS-8201: 5.4mg/kgPrimary endpoint: ORRSecondary endpoint: ORR, DOR,DCR, PFS, OS, safetyJP/US/EU/AsiaFPD: Mar 2021Apr 2022: Filing accepted (US)May 2020: Breakthrough TherapyDesignation (US)HER2 positive NSCLC, 1LPhase 3DESTINY-Lung04NSCLC with HER2 exon 19 orexon 20 mutation, 1L120 Non-randomized, three-part (safety run-in,dose escalation, dose expansion)・DS-8201 + durvalumab + cisplatin・DS-8201 + durvalumab + carboplatin・DS-8201 + durvalumab + pemetrexed・DS-8201 + durvalumab264 Randomized, open label・DS-8201・pemetrexed + pembrolizumab + cisplatinor carboplatinPrimary endpoint: SafetySecondary endpoint: ORR, DOR,DCR, PFS, OS, PK, etc.EU/Asia FPD: Nov 2021Primary endpoint: PFSSecondary endpoint: OS, PFS,ORR, DOR, safety, PK, etc.JP/US/EU/AsiaFPD: Dec 2021NCT04989816AstraZenecaNCT03505710JapicCTI-183916AstraZenecaPhase 2DESTINY-Lung02NCT04644237jRCT2061200038AstraZenecaPhase 1bDESTINY-Lung03NCT04686305AstraZenecaNCT05048797jRCT2011210058AstraZeneca27Trastuzumab deruxtecan/DS-8201/T-DXd (HER2-directed ADC)Study NameStudy DesignPopulationPhase ２DESTINY-Lung05NSCLC with HER2 exon 19 orexon 20 mutation, 2L or laterOpen label・DS-8201Samplesize66Evaluation ItemsRegion StatusPrimary endpoint: ORRSecondary endpoint: ORR, DOR,DCR, PFS, OS, PK, ADA, safetyChinaFPD: FY2022 H1NSCLC, 2L or later420 Non-randomized, open label, combinationwith durvalumab・DS-8201 + durvalumab* Umbrella study of durvalumab led byAstraZenecaNon-randomized, open label・DS-820190Primary endpoint: ORRSecondary endpoint: DCR, ｂestpercentage change in tumor size,DOR, PFS, OSUS/EU/AsiaFPD: Jun 2020Primary endpoint: ORRSecondary endpoint: PFS, OS,DOR, DCR, ORR, PKJP/US/EU FPD: Mar 2018HER2 expressing colorectalcancer, 3LPhase 2DESTINY-CRC02HER2 overexpressing colorectalcancer, 3L120 Randomized, double blind・DS-8201 : 6.4mg/kg･DS-8201 : 5.4mg/kgPrimary endpoint: ORRSecondary endpoint: DOR, DCR,PFS, OS, PK, PRO, safetyJP/US/EU/AsiaFPD: Mar 2021100 Open label・DS-8201Primary endpoint: ORRSecondary endpoint: DOR, DCR,PFS, ORR, OS, safety, PKJP/US/EU/AsiaFPD: Jan 2021HER2 mutated tumors(e.g. colorectal cancer, urothelialcancer, gastric cancer,hepatobiliary cancer, endometrialcancer, melanoma, ovarian cancer,cervical cancer, salivary glandcancer, pancreatic cancer, breastcancer)NCT05246514AstraZenecaPhase 2HUDSONNCT03334617AstraZenecaPhase 2DESTINY-CRC01NCT03384940JapicCTI-173808AstraZenecaNCT04744831jRCT2051200124AstraZenecaPhase 2DESTINY-PanTumor01NCT04639219jRCT2031210132AstraZeneca28Trastuzumab deruxtecan/DS-8201/T-DXd (HER2-directed ADC)Study NamePopulationStudy DesignSamplesize280 Non-randomized・DS-8201Evaluation ItemsRegion StatusPrimary endpoint: ORRSecondary endpoint: DOR, DCR,PFS, OS, safety, PK, ADAUS/EU/AsiaFPD: Oct 2020Phase 2DESTINY-PanTumor02HER2 expressing tumors (bladdercancer, biliary tract cancer, cervicalcancer, endometrial cancer,ovarian cancer, pancreatic cancer,rare tumors)HER2 positive/low breast cancerHER2 positive/low urothelialcarcinomaNCT04482309AstraZenecaPhase 1NCT03523572BMSPhase 1NCT04042701MerckPhase 1/2aPETRANCT04644068AstraZeneca99Non-randomized, open label, combinationwith nivolumab, two-part (dose escalation,dose expansion)・DS-8201 + nivolumabPrimary endpoint: ORR, safetySecondary endpoint: DOR, DCR,PFS, OS, ORRUS/EU FPD: Aug 2018HER2 positive/low breast cancerHER2 expressing/mutated NSCLC115 Non-randomized, open label,combination with pembrolizumab・DS-8201 + pembrolizumabPrimary endpoint: Safety, ORRSecondary endpoint: DOR, DCR,PFS, TTR, OSUS/EU FPD: Apr 2020Solid tumors715 Non-randomized, open label, combinationwith AZD5305・DS-8201 + AZD5305Primary endpoint: SafetySecondary endpoint: Tumor sizechange, ORR, DOR, PFS, TTR,PK, ADA, etcUS/EU/Asia29Datopotamab deruxtecan/DS-1062/Dato-DXd (TROP2-directed ADC)Antibody-drug conjugate which is composed of a humanized monoclonal antibody specifically targeting TROP2 (Research collaboration with Sapporo Medical University). TROP2 is an antigenhighly expressed on the cell membrane of cancer cells, and a covalently linked drug (payload) via a cleavable linker. Payload is a potent and membrane permeable DNA topoisomerase I inhibitorwhich enables elimination of both target tumor cells and the surrounding tumor cells. Drug-to-antibody ratio is approximately 4.Study NamePopulationEvaluation ItemsRegion StatusStudy DesignSamplesize770 Open label, two-part (dose escalation,dose expansion)・DS-1062Primary endpoint: SafetySecondary endpoint: PK, ADAJP/US FPD: Feb 2018NSCLCTriple negative breast cancerHR positive breast cancerSCLCTransitional cell carcinoma of theurotheliumHER2 negative gastroesophagealcancerEsophageal cancerPhase 1TROPION-PanTumor01NCT03401385JapicCTI-173812AstraZenecaPhase 3TROPION-Lung01NCT04656652jRCT2071200104AstraZenecaPhase 1TROPION-Lung02NCT04526691jRCT2031200193MerckAstraZenecaNSCLC, 2L/3L590 Randomized, open label・DS-1062・DocetaxelPrimary endpoint: PFS, OSSecondary endpoint: ORR, DOR,TTR, DCR, safety, PK, ADAJP/US/EU/AsiaFPD: Feb 2021NSCLC (without actionablemutation)Part1: 3L or laterPart2: 1L/2L120 Open label, combination withpembrolizumab, two-part (doseescalation, dose expansion)・DS-1062 + pembrolizumab ± platinumchemotherapyPrimary endpoint: Safety andtolerabilitySecondary endpoint: ORR, DOR,PFS, OS, PK, ADAJP/US/EU/AsiaFPD: Oct 202030Datopotamab deruxtecan/DS-1062/Dato-DXd (TROP2-directed ADC)Study NameStudy DesignPopulationEvaluation ItemsRegion StatusPhase 1TROPION-Lung04NSCLC (without actionablemutation), 1L/2LSamplesize68Open label, combination withdurvalumab, two-part (dose escalation,dose expansion)・DS-1062 + durvalumab ± carboplatinPrimary endpoint: Safety andtolerabilitySecondary endpoint: ORR, DOR,PFS, OS, PK, ADAJP/US/EU FPD: Mar 2021NSCLC (with actionable mutation)150 Open label・DS-1062Primary endpoint: ORRSecondary endpoint: DOR, PFS,OS, safety, PKJP/US/EU/AsiaFPD: Mar 2021NSCLC (without actionablemutation and PD-L1 ≥50%), 1L740 Randomized, open label・DS-1062 + pembrolizumab・PembrolizumabPrimary endpoint: PFS, OSSecondary endpoint: ORR, PFS,DOR, TTR, DCR, Time todeterioration (TTD), safety, ADA,etc.JP/US/EU/AsiaFPD: Mar 2022Triple negative breast cancer200 Non-randomized, open label,combination with durvalumab・DS-1062 + durvalumabPrimary endpoint: SafetySecondary endpoint: ORR, PFS,DOR, OS, PKUS/EU/AsiaFPD: May 2021Phase 3TROPION-Breast01HR positive/HER2 negative breastcancer, 2L/3LPrimary endpoint: PFS, OSSecondary endpoint: ORR, DOR,PFS, DCR, PK, ADA, etcJP/US/EU/AsiaFPD: Nov 2021* Umbrella study of durvalumab led byAstraZeneca700 Randomized, open label・DS-1062* Physician’s choice (capecitabine,gemcitabine, eribulin or vinorelbine)Solid tumors715 Non-randomized, open label, combinationwith AZD5305・DS-1062 + AZD5305Primary endpoint: SafetySecondary endpoint: Tumor sizechange, ORR, DOR, PFS, TTR,PK, ADA, etcJP/US/EU/AsiaFPD: Mar 2022NCT04612751jRCT2031200449AstraZenecaPhase 2TROPION-Lung05NCT04484142jRCT2041200097AstraZenecaPhase 3TROPION-Lung08NCT05215340jRCT2061210074MerckAstraZenecaPhase 1b/2BEGONIANCT03742102AstraZenecaNCT05104866jRCT2031210440AstraZenecaPhase 1/2aPETRANCT04644068AstraZeneca31Patritumab deruxtecan/U3-1402/HER3-DXd (HER3-directed ADC)Antibody-drug conjugate which is composed of fully human monoclonal antibody specifically targeting HER3, one of the Epidermal Growth Factor Receptor (EGFR) family proteins, and a covalentlylinked drug (payload) via a cleavable linker. Payload is a potent and membrane permeable DNA topoisomerase I inhibitor which enables elimination of both target tumor cells and the surroundingtumor cells. Drug-to-antibody ratio is approximately 8.Study NamePopulationPhase 1/2Breast cancerStudy DesignSamplesize184 Randomized, open label, two-part (doseescalation, dose expansion)・U3-1402Evaluation ItemsRegion StatusPrimary endpoint: Safety, antitumoreffectSecondary endpoint: PKJP/US FPD: Dec 2016NSCLC216 Non-randomized, open label, two-part(dose escalation, dose expansion)・U3-1402Primary endpoint: Safety, ORRSecondary endpoint: PK, ORR,DCR, DOR, TTR, PFS, OS, safetyJP/US/EU/AsiaFPD: Feb 2018EGFR mutated NSCLC, 3L420 Randomized, open label・U3-1402Primary endpoint: ORRSecondary endpoint: DOR, PFS,ORR, DCR, TTR, OS, safetyJP/US/EU/AsiaFPD: Feb 2021Dec 2021: Breakthrough TherapyDesignation (US)EGFR mutated NSCLC, 1/2L252 Non-randomized, open label, two-partJP/US FPD: Jun 2021(dose escalation, dose expansion)・U3-1402 + OsimertinibEGFR mutated NSCLC, 2L560 Randomized, open label, active control・U3-1402・Platinum-based chemotherapyJP/US/EU/AsiaFPD planned: FY2022 H1Primary endpoint: Safety, ORRSecondary endpoint: ORR, DOR,DCR, TTR, PFS, OS, safety, PK,etc.Primary endpoint: PFSSecondary endpoint: OS, PFS,ORR, DOR, CBR, DCR, safety,etc.NCT02980341JapicCTI-163401Phase 1NCT03260491JapicCTI-194868Phase 2HERTHENA-Lung01NCT04619004jRCT2031200186Phase 1NCT04676477jRCT2031200247AstraZenecaPhase 3 prepHERTHENA-Lung02NCT05338970jRCT202122000232◆ Alpha (Oncology Late-Stage Pipeline Products)Quizartinib/AC220 (FLT3 inhibitor)Kinase inhibitor against a receptor-type tyrosine kinase, FLT3. Therapeutic effect for patients with acute myeloid leukemia harboring FLT3-ITD mutation is expected.Brand name: VANFLYTA (JP)Study NamePopulationEvaluation ItemsRegion StatusStudy DesignSamplesize367 Randomized, open label, active-controlled・Quizartinib・ChemotherapyPrimary endpoint: OSSecondary endpoint: EFSJP/US/EU/AsiaFPD: May 2014TLR: May 2018Phase 3QuANTUM-RNCT02039726Acute myeloid leukemia,relapsed/refractoryPhase 3QuANTUM-FirstNCT02668653JapicCTI-173667Acute myeloid leukemia, 1L539 Randomized, double-blind, placebo-Primary endpoint: OSSecondary endpoint: EFS, etc.JP/US/EU/Asiacontrolled・Quizartinib + chemotherapy・Placebo + chemotherapyJun 2019: Received CRL (US)Oct 2019: Launch (JP)Oct 2019: Received negativeCHMP opinion (EU)Mar 2009: Orphan DrugDesignation (US/EU)Submission strategy in US/EU/Asiais under discussion, together with1L indicationFPD: Sep 2016TLR: Nov 2021Filing anticipated: FY2022 H1Mar 2009: Orphan DrugDesignation (US/EU)33Pexidartinib/PLX3397 (CSF-1/KIT/FLT3 inhibitor)The molecular-targeted agent to inhibit CSF-1R, KIT and FLT3. This agent is expected to reduce tumor cell proliferation and expansion of metastases.Brand name: TURALIO (US)Study NamePopulationEvaluation ItemsRegion StatusPhase 3Tenosynovial giant cell tumorTenosynovial giant cell tumor21NCT04488822Phase 2NCT04703322jRCT2041200074Samplesize35Study DesignOpen label・PexidartinibOpen label・PexidartinibPrimary endpoint: ORRSecondary endpoint: TVS, ROM,PROMIS, DOR, etc.Primary endpoint: Safety, PK, ORRSecondary endpoint: Safety, TVS,ROM, PROMIS, DOR, etc.AsiaFPD: Sep 2020JPFPD: Apr 2021Teserpaturev/DS-1647/G47Δ (oncolytic HSV-1)The third generation oncolytic herpes simplex virus type 1(HSV-1), genetically-engineered to restrict virus replication to tumor cells. This oncolytic virus therapy is expected equal or better safetyand better efficacy profile compare to existing oncolytic virus.Brand name: DELYTACT (JP)Study NamePopulationStudy DesignEvaluation ItemsRegion StatusPhase 2/IIS (pivotal)Malignant gliomaActiVec Inc.Samplesize30Non-randomized, open label・DS-1647/G47ΔPrimary endpoint: 1-year survivalrateSecondary endpoint: OS, PFS,tumor responseJPTLR: FY2018 Q4Dec 2020: SubmissionJun 2021: ApprovalNov 2021: LaunchFeb 2016: SAKIGAKE DesignationJul 2017: Orphan Drug Designation34Axicabtagene ciloleucel/Axi-CelTM (anti-CD19 CAR-T cells)Chimeric antigen receptor T (CAR-T), which is a cell therapy directed against CD19, an antigen expressed on the surface of B-cell malignant lymphoma cells.Brand name: YESCARTA (JP)Study NamePopulationStudy DesignEvaluation ItemsRegion StatusRelapsed/refractory large B-celllymphomaNon-randomized, open label・Axicabtagene ciloleucelSamplesize10Primary endpoint: ORRSecondary endpoints: Safety,ORR, DOR, PFS, OS, PKJPFPD: Nov 2018Jan 2021: ApprovalOct 2018: Orphan DrugDesignationValemetostat/DS-3201 (EZH1/2 inhibitor)Inhibitor of histone methylases, EZH1 and EZH2. Some cancer cells grow dependently on these enzymes.Study NameStudy DesignPopulationPhase 2 (pivotal)Adult T-cell leukemia/lymphomaSamplesize25Open label・DS-3201Evaluation ItemsRegion StatusPrimary endpoint: ORRSecondary endpoint: ORR, CRrate, TTR, DOR, PFS, OS, etc.JPFPD: Dec 2019TLR: Jul 2021Submission: Dec 2021Phase 2 (pivotal)VALENTINE-PTCL01Relapsed/refractory peripheral T-cell lymphoma176 Non-Randomized, open label・DS-3201Primay endpoint: ORRSecondary endpoint: DOR, CRrate, safety, etc.JP/US/EU/AsiaFPD: Jun 2021Nov 2021: Orphan DrugDesignationApr 2019: SAKIGAKE Designation(JP)Dec 2021: Orphan DrugDesignation (US)Relapsed/refractory B-celllymphoma141 Non-Randomized, open label・DS-3201Primay endpoint: ORRSecondary endpoint: CR rate,PFS, DOR, TTR, safety, PKEUFPD: Jun 2021Phase 1Non-Hodgkin’s lymphomas100 Open label・DS-3201Primary endpoint: Safety, PK,antitumor effectSecondary endpoint: ORR, DCR,DOR, PFS, etc.JP/US FPD: Apr 2016Phase 2JapicCTI-183914Kite/GileadNCT04102150JapicCTI-194964NCT04703192jRCT2071200095Phase 2NCT04842877LYSANCT02732275JapicCTI-16317335◆ Alpha (Oncology Early-Stage Pipeline Products)DS-1001 (Mutant IDH1 inhibitor)Study NamePopulationPhase 1GliomaNCT03030066JapicCTI-163479Phase 2NCT04458272JapicCTI-205339GliomaPLX2853 (BET inhibitor)Study NamePopulationSamplesize47Study DesignOpen label・DS-100125Open label・DS-1001Relapsed/refractory acute myeloidleukemia, myelodysplasticsyndromeAdvanced malignanciesSamplesize22Study DesignOpen label・PLX2853166 Open label・PLX2853Gynecologic neoplasmsEpithelial ovarian cancer67Non-randomized, open label・PLX2853 + carboplatinPhase 1NCT03787498Phase 1NCT03297424Phase 1b/2aNCT04493619NCT04556617Evaluation ItemsRegion StatusPrimary endpoint: SafetySecondary endpoint: Safety, PK,antitumor effectPrimary endpoint: ORR, safetySecondary endpoint: antitumoreffect, TTR, DOR, PFS, OS, PK,etcJPFPD: Jan 2017JPFPD: Jul 2020Evaluation ItemsRegion StatusUSFPD: Mar 2019USFPD: Sep 2017USFPD: Aug 2020Primary endpoint: Safety, PKSecondary endpoint: OCR, ORR,DOR, EFS, PFS, OSPrimary endpoint: Safety, PK,antitumor effectSecondary endpoint: ORR, DOR,PFS, OSPrimary endpoint: ORR, MTD,RP2DSecondary endpoint: Safety, DOR,DCR, PFS, OS, PKPrimary endpoint: ORR, safetySecondary endpoint: PFS, OS, PK,etc.Phase 1/2Prostate cancer110 Non-randomized, open labelUSFPD: Sep 2020・PLX2853 + abiraterone acetate +prednisone・PLX2853 + olaparib36DS-7300 (B7-H3-directed ADC)Study NamePopulationPhase 1/2NCT04145622JapicCTI-194992Phase 2 prepNCT05280470Esophageal squamous cellcarcinoma, castration-resistantprostate cancer, SCLC, etc.SCLCStudy DesignSamplesize160 Non-randomized, open label, two-part(dose escalation, dose expansion)・DS-730080Randomized, open label・DS-7300 : 8mg/kg・DS-7300 : 12mg/kgEvaluation ItemsRegion StatusJP/US FPD: Oct 2019Primary endpoint: Safety, antitumoreffectSecondary endpoint: PK, etc.Primary endpoint: ORRSecondary endpoint: Safety, PFS,DOR, OS, TTR, ORR, DCR, PK,ADAJP/US/EU/AsiaFPD planned: FY2022 H1DS-1055（anti-GARP antibody)Study NamePopulationPhase 1Solid tumorsSamplesize40NCT04419532JapicCTI-205292DS-6000（CDH6-directed ADC）Study NamePopulationPhase 1NCT04707248Renal cell carcinoma, ovariancancerDS-1594（Menin-MLL binding inhibitor）Study NamePopulationAcute myeloid leukemia,acute lymphoblastic leukemiaPhase 1/2NCT04752163MD AndersonStudy DesignEvaluation ItemsRegion StatusNon-randomized, open label・DS-1055Primary endpoint: SafetySecondary endpoint: PK, ADA, etc.JP/US FPD: Oct 2020Study DesignSamplesize102 Non-randomized, open label, two-part(dose escalation, dose expansion)・DS-6000Evaluation ItemsRegion StatusPrimary endpoint: SafetySecondary endpoint: PK, ORR,DOR, DCR, etc.USFPD: Jan 2021Study DesignSamplesize122 Non-randomized, open label・DS-1594･DS-1594 + venetoclax + azacitidine･DS-1594 + mini HCVD･DS-1594 + posaconazol or voriconazoleEvaluation ItemsRegion StatusPrimary endpoint: Safety, CR rateSecondary endpoint: CR rate,MLFS rate, PR rate, ORR,DOR,EFS, OS, mortality rate, etc.USFPD: Apr 202137◆ Alpha (Specialty Medicines Late-Stage Pipeline Products)Edoxaban/DU-176b (Factor Xa inhibitor)The once daily oral anti coagulant (Factor Xa inhibitor) discovered by Daiichi Sankyo. Edoxaban specifically, reversibly and directly inhibits the enzyme, Factor Xa, a clotting factor in the blood.Brand name: LIXIANA (JP/EU/ Asia), SAVAYSA (US)Study NamePopulationEvaluation ItemsRegion StatusPhase 3NCT02801669JapicCTI-163266Very elderly patients with non-valvular atrial fibrillationcontrolled・Edoxaban・PlaceboStudy DesignSamplesize984 Randomized, double-blind, placebo-Primary endpoint: annual incidencerate of stroke and systemic emboliceventsSecondary endpoint: annualincidence rate of bleeding eventsJPFPD: Aug 2016TLR: Apr 2020Submission: Sep 2020Approval : Aug 2021Prasugrel/CS-747 (ADP receptor inhibitor)Oral antiplatelet agents. Supress arterial stenosis and occlusion by inhibiting platelet aggregation.Brand name: EFIENT (JP/EU), EFFIENT (US/Asia)Study NamePopulationPhase 3Ischemic strokeStudy DesignSamplesize250 Randomized, double-blind, active-JapicCTI-184141Evaluation ItemsRegion StatusPrimary endpoint: incidence rate ofcerebro-cardiovascular eventsSecondary endpoint: incidence rateof bleeding eventsJPFPD: Oct 2018TLR: Jun 2020Submission: Dec 2020Approval : Dec 2021Mirogabalin/DS-5565 (α2δ ligands)The pain therapy agent to reduce the neurotransmitter release from nerve terminals. This agent is expected to show the good balanced efficacy and safety profile.Brand name: TARLIGE (JP)Study NamePopulationEvaluation ItemsRegion StatusPhase 3Central neuropathic painStudy DesignSamplesize300 Randomized, double-blind, placebo-NCT03901352JapicCTI-194653Phase 3NCT04094662Diabetic peripheral neuropathicpain360 Randomized, double-blind, placebo-ChinaFPD: Sep 2019JP/Asia FPD: Mar 2019TLR: Dec 2020Submission: May 2021Approval: Mar 2022Primary endpoint: average dailypain scoreSecondary endpoint: visualanalogue scale, average dailysleep interference scorePrimary endpoint: average dailypain scoreSecondary endpoint: visualanalogue scale, average dailysleep interference scorecontrolled・Prasugrel・Clopidogrelcontrolled・Mirogabalin・Placebocontrolled・Mirogabalin・Placebo38Esaxerenone/CS-3150 (MR blocker)The agent inhibits aldosterone binding to Mineralocorticoid Receptor (MR) which stimulate the sodium absorption into kidney. This agent is expected to exhibit antihypertensive and organ-protective effect.Brand name: MINNEBRO (JP)Study NamePopulationEvaluation ItemsRegion StatusStudy DesignSamplesize400 Randomized, double-blind, placebo-controlled・Esaxerenone・PlaceboPrimary endpoint: UACR remissionrateSecondary endpoint: change ratein UACR and eGFR, etc.JPFPD: Sep 2017TLR: Jul 2019Phase 3Diabetic nephropathyJapicCTI-173695Exelixis, Inc.39 Alpha (Specialty Medicines Early-Stage Pipeline Products)Renadirsen Sodium/DS-5141 (ENA-oligonucleotides)Study NameStudy DesignPopulationPhase 1/2Duchenne muscular dystrophySamplesize8Open label・DS-5141NCT02667483JapicCTI-153072ODTINCT04433234JapicCTI-205321Evaluation ItemsRegion StatusPrimary endpoint: Safety, PK,dystrophin protein expression inmuscle tissueSecondary endpoint: production ofexon 45-skipped dystrophin mRNAin muscle tissueJPFPD: Oct 2015TLR: Dec 2020Apr 2017: SAKIGAKE DesignationApr 2018: announced TLR of 12-week treatment studyJun 2021: announced TLR of 48-week treatment studyPhase 2Duchenne muscular dystrophy8Long-term study of above phase 1/2study・DS-5141Endpoint: Safety, motor function,respiratory function, cardiacfunction, quantitative musclestrength evaluation, PKJPDS-1211 (TNAP inhibitor)Study NamePopulationPhase 2 prepPseudoxanthoma elasticumUSSAD and MAD studies completedSamplesizeStudy DesignEvaluation ItemsRegion StatusDS-6016 (anti-ALK2 antibody)Study NamePopulationPhase 1NCT04818398jRCT2051200155Samplesize48Study DesignEvaluation ItemsRegion StatusHealthy volunteers, fibrodysplasiaossificans progressivaRandomized, double-blind, placebo-controlledPrimary endpoint: SafetySecondary endpoint: PKJPFSD: Apr 2021TLR：Mar 202240DS-7011 (anti-TLR7 antibody)Study NamePopulationSamplesizeSt