第一三共（4568） – FY2021 Financial Results Presentation

FY2021 Financial Results PresentationDAIICHI SANKYO CO., LTD.Sunao ManabePresident and CEOApril 27, 20221Forward-Looking StatementsManagement strategies and plans, financial forecasts, future projections and policies, and R&D information that Daiichi Sankyo discloses in this material are all classified as Daiichi Sankyo’s future prospects. These forward-looking statements were determined by Daiichi Sankyo based on information obtained as of today with certain assumptions, premises and future forecasts, and thus, there are various inherent risks as well as uncertainties involved. As such, please note that actual results of Daiichi Sankyo may diverge materially from Daiichi Sankyo’s outlook or the content of this material. Furthermore, there is no assurance that any forward-looking statements in this material will be realized. Regardless of the actual results or facts, Daiichi Sankyo is not obliged and does not have in its policy the duty to update the content of this material from the date of this material onward.Some of the compounds under discussion are investigational agents and are not approved by the FDA or any other regulatory agencyworldwide as a treatment for indications under investigation. Efficacy and safety have not been established in areas under investigation. There are no guarantee that these compounds will become commercially available in indications under investigation.Daiichi Sankyo takes reasonable care to ensure the accuracy of the content of this material, but shall not be obliged to guarantee the absolute accuracy, appropriateness, completeness and feasibility, etc. of the information described in this material. Furthermore, any information regarding companies, organizations or any other matters outside the Daiichi Sankyo Group that is described within this material has been compiled or cited using publicly available information or other information, and Daiichi Sankyo has not performed in-house inspection of the accuracy, appropriateness, completeness and feasibility, etc. of such information, and does not guarantee the accuracy thereof.The information described in this material may be changed hereafter without notice. Accordingly, this material or the information described herein should be used at your own judgment, together with any other information you may otherwise obtain.This material does not constitute a solicitation of application to acquire or an offer to sell any security in the United States, Japan or elsewhere.This material disclosed here is for reference purposes only. Final investment decisions should be made at your own discretion.Daiichi Sankyo assumes no responsibility for any damages resulting from the use of this material or its content, including without limitation damages related to the use of erroneous information.2Agenda1FY2021 Financial Results2FY2022 Forecast3Business Update4R&D Update55-Year Business Plan Update6Appendix3Overview of FY2021 ResultsFY2020ResultsFY2021Results1,044.9+8.6%(Bn JPY)YoYRevenueCost of sales*SG&A expensesR&D expenses**Core operating profit*Temporary income *Temporary expenses*Operating profitProfit before taxProfit attributable to ownersof the CompanyCurrencyRateUSD/JPYEUR/JPY962.5337.8318.5227.478.90.615.663.874.176.0106.06123.70348.0352.1254.190.63.921.573.073.567.0112.38130.56+14.9%+14.5%-11.8%82.410.333.726.711.83.45.99.2-0.6-9.0+6.32+6.86*As an indicator of ordinary profitability, “core operating profit” which excludes temporary income and expenses from operating income is disclosed.Income and expenses 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”.Temporary income and expenses are excluded from results and forecast for cost of sales, SG&A expenses and R&D expenses shown in the list above. The adjustment table from operating profit to core operating profit is stated in the reference data4RevenueIncreased by 82.4 Bn JPY (Increased by 53.7 Bn JPY excl. forex impact)Positive FactorsNegative Factors(Bn JPY)FY2020 ResultsFY2020 ResultsJapan Business(incl. Innovative Pharmaceuticals,Japan BusinessGeneric, Vaccines, OTC)Oncology Business*1Oncology Business962.53.8American RegentAmerican Regent BusinessEU SpecialityEU Specialty BusinessBusinessASCAASCA Business(Asia, South and Central America)Enhertu, Dato-DXd*2DS-8201/DS-1062Upfront Payment & Regulatory Milestone etc.Forex ImpactForex Impact*33.818.30.019.30.09.90.05.80.04.20.028.70.0Japan Business UnitLixianaTarligeEnhertuEmgalityDaiichi Sankyo EsphaEzetimibe AG and othersOncology Business*1 Unit Enhertu+15.1+9.6+5.2+4.6+11.4American Regent UnitInjectaferGE injectables+5.9+9.8EU Specialty Business UnitLixiana+15.1NexiumMemary-39.6-11.0+25.6Olmesartan-3.8FY2021 ResultsFY2021 Results1,044.9800.0Positive Factors850.0900.0950.0Negative Factors1,000.01,050.0*1 Revenue for Daiichi Sankyo, Inc. and Daiichi Sankyo Europe’s oncology products *2 Dato-DXd: Datopotamab deruxtecan (DS-1062)*3 Forex impact USD: +12.7, EUR : +7.2, ASCA: +8.7Enhertu, Dato-DXd*2 Upfront Payment & Regulatory Milestone etc.Enhertu quid related paymentDato-DXd upfront payment+3.4+2.15Gain on sales of transferring current productsOlmesartan-3.1-2.3Core Operating ProfitIncreased by 11.8 Bn JPY (Increased by 7.9 Bn JPY excl. forex impact) FY2020 ResultsFY2020 Results78.9RevenueRevenue0.082.4Cost of SalesCost of SalesSG&A ExpensesSG&A ExpensesRevenue+82.4incl. forex impact of +28.7Cost of Sales+6.5(Bn JPY)0.06.5SG&A Expenses+22.0Improvement in cost of sales ratio by change in product mix22.00.0Increase in expenses related to Enhertu due to an increase in profit share of gross profit with AstraZenecaR&D ExpensesR&D Expenses0.017.5Forex ImpactForex Impact24.70.0FY2021 ResultsFY2021 Results90.61.021.041.081.061.0Positive Factors101.0121.0141.0Negative Factors161.0R&D Expenses+17.5Increase in 3ADCs* R&D investmentsForex ImpactCost of SalesSG&A ExpensesR&D Expenses+24.7+3.8+11.7+9.2* 3ADCs: 1) Enhertu, Trastuzumab deruxtecan (T-DXd, DS-8201), 2) Datopotamab deruxtecan (Dato-DXd, DS-1062) and 3) Patritumab deruxtecan (HER3-DXd, U3-1402)6Profit Attributable to Owners of the CompanyDecreased by 9.0 Bn JPYTemporary Income/Expenses+2.5 (Profit decreased)(Bn JPY)FY2020 ResultsFY2020 ResultsCoreCore Operating OperatingProfitProfitTemporaryTemporary Income/ RevenueExpenses/ ExpensesFinancialFinancial Income/ Expenses etc./ ExpensesIncome76.011.80.01.52.50.09.8Income Taxes etc.Income Taxes etc.0.08.2FY2021 ResultsFY2021 Results67.00.010.020.030.0Positive Factors40.050.060.070.0Negative Factors80.090.0FY2020FY2021YoYTemporary IncomeTemporary Expenses0.615.6*13.9*221.5*3+3.4+5.9*1 Vaccine business loss compensation (15.0)*2 Gains related to sale of Osaka logistics center (2.1)*3 Environmental expenditures related to former Yasugawa plant (9.5)Losses related to closure of Plexxikon (5.8)Financial Income/Expenses etc.+9.8 (Profit decreased）FY2020: Financial income due to decrease in contingent consideration of Ambit/quizartinib acquisitionDeterioration in forex gains/losses+4.7+1.1Income Taxes etc.+8.2 (Profit decreased）FY2020FY2021YoYProfit before TaxIncome Taxes etc.Tax rate74.1（参考：税率）-1.7-2.3%73.56.58.9%-0.6+8.2+11.2%FY2020: Decrease in Income taxes due to an increase in DTA attributable to future expected taxable income increase of 3ADCsFY2021: Impact of tax credit for R&D expenses and others7Revenue: Business Units (incl. Forex Impact) Japan Business Daiichi Sankyo Healthcare Oncolgy Business　Enhertu　Turalio American Regent　Injectafer　Venofer　GE injectables EU Speciality Business　Lixiana　Nilemdo/Nustendi　Olmesartan ASCA (Asia, South and Central America)CurrencyRateUSD/JPYEUR/JPY67.247.425.71.8121.744.128.841.8111.776.70.621.599.7106.06123.70FY2020Results489.1FY2021Results489.5(Bn JPY)YoY+0.4-2.5+22.2+28.7+1.0+27.7+8.9+4.9+12.9+16.6+20.2+2.6-1.2+14.5+6.32+6.8664.769.654.42.8149.553.133.854.7128.296.93.120.3114.1112.38130.568Revenue: Major Products in JapanLixianaanticoagulantNexiumulcer treatmentPraliatreatment for osteoporosis/ inhibitor of the progression ofbone erosion associated with rheumatoid arthritisTarligepain treatmentTeneliatype 2 diabetes mellitus treatmentRanmarkmetastases from tumorstreatment for bone complications caused by boneLoxoninanti-inflammatory analgesicVimpatanti-epileptic agentCanaliatype 2 diabetes mellitus treatmentEfientantiplatelet agentEnhertuanti-cancer agent(HER2-directed antibody drug conjugate)Rezaltasantihypertensive agentInaviranti-influenza agent77.477.834.620.624.219.324.214.515.414.14.413.13.6FY2020ResultsFY2021Results(Bn JPY)YoY+15.1-38.2+3.3+9.6-0.6+1.1-2.0+3.7+1.4+2.7+5.2-1.1-2.392.539.637.930.123.720.422.218.316.816.79.612.01.39Agenda1FY2021 Financial Results2FY2022 Forecast3Business Update4R&D Update55-Year Business Plan Update6Appendix10FY2022 ForecastRevenueCost of sales*SG&A expensesR&D expenses**Core operating profit*Temporary income *Temporary expenses*Operating profitProfit before taxProfit attributable to ownersof the CompanyFY2021Results1,044.9FY2022Forecast1,150.0(Bn JPY)vs. Forecast105.1348.0352,1254.190.63.921.573.073.567.0328.0410.0307.0105.0–105.0105.083.0130.00140.00-20.057.952.914.4-3.9-21.532.031.516.017.629.44RevenueIncrease factor Sales expansion of main products (Enhertu, Lixiana, Tarlige, etc.)Decrease Factor Drug price revision, Termination of joint sales promotion for NexiumCost of salesImprovement in cost of sales ratio by change in product mix and othersSG&A expensesIncrease in expenses related to Enhertu due to an increase in profit share of gross profit with AstraZeneca and othersR&D expensesIncrease in 3ADCs R&D investments and othersTemporary expensesFY2021: Environmental expenditures related to former Yasugawa plant Losses related to closure of PlexxikonProfit attributable to owners of the CompanyFY2021: Impact of Tax credit for R&D expenses and othersForex ImpactRevenue +55.0 Bn JPY, Core operating profit -6.0 Bn JPYCurrencyRateUSD/JPYEUR/JPY112.38130.56COVID-19ImpactCertain activity restrictions are expected to continue during FY2021, however impact on core operating profit is expected to be minor* As an indicator of ordinary profitability, “core operating profit” which excludes temporary income and expenses from operating income is disclosed.Income and expenses related to: sale of fixed assets, restructuring (excluding the sales of pipeline and launched products), impairment, loss compensation, reconciliation, and other non temporaryand material gains and losses are included in the “temporary income and expenses”.Temporary income and expenses are excluded from results and forecast for cost of sales, SG&A expenses and R&D expenses shown in the list above.11Agenda1FY2021 Financial Results2FY2022 Forecast3Business Update4R&D Update55-Year Business Plan Update6Appendix12Progress towards “Maximize 3ADCs”Progress towards “Profit growth for current business and products”13ENHERTU®: Transform Treatment for Breast Cancer PatientsTransform the treatment landscape for previously “un-targetable” HER2 low BC patients HER2-Low patient totals are approximately 2x HER2 positive BC patients BC Market Space by HER2 Status Current SOC for Unresectable or Metastatic HER2-low BC PatientsHR+/HER2 lowET* ± CDK4/6iHR-/HER2 lowChemo ± I/OChemotherapyChemotherapyChemotherapy*ET: Endocrine Therapy HER2+(IHC 3+, 2+/ISH+)HR+/HER2 low(IHC 1+, 2+/ISH-)HR-/HER2 low(IHC 1+, 2+/ISH-)HR+/HER2-(IHC 0)HR-/HER2-(IHC 0)ENHERTU® Ph3 Studies DESTINY-Breast04HER2 low BC, post-chemo Obtained topline results in Feb. 2022 sBLA planned in FY2022 H1 DESTINY-Breast06HER2 low BC, chemo-naïve14ENHERTU®: RevenueFY2021 ResultsFY2022 ForecastRegulatory milestone payment-1.320.618.3Product SalesJapanUSEuropeASCAUpfront 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 2LYoY35.35.219.79.01.4-0.5-0.8——-65.49.645.49.01.4*19.8*12.20.90.50.8—–128.416.083.123.06.39.8*1*10.90.50.83.42.66.91.24.3YoY63.06.437.714.04.9—-3.42.66.91.24.3-2.379.1(Bn JPY)TotalConsideration—–149.033.713.77.912.113.0*29.8*226.0*24.6*213.1*217.2300.2Quid related payment3.4*13.41.1*1Total80.837.4159.9*1 Revenue recognized in each period *2 Expected consideration based on the assumption of achieving milestones in FY202215ENHERTU®: Performance in Each Region Steady increase in product sales due to market penetration in launched countries and market expansion Product sales: FY2021 results 65.4 Bn JPY（YoY +35.3 Bn JPY）FY2022 forecast 128.4 Bn JPY（YoY +63.0 Bn JPY）US (HER2+ Breast Cancer 3L, HER2+ Gastric Cancer 2L)Europe (HER2+ Breast Cancer 3L) Product sales: FY2021 results 45.4 Bn JPY (404 Mn USD) Product sales: FY2021 results 9.0 Bn JPY (80 Mn USD)FY2022 forecast 83.1 Bn JPY (639 Mn USD)FY2022 forecast 23.0 Bn JPY (177 Mn USD) Steady growth in the market Steady growth in the market HER2+ BC 3L: Maintaining No.1 new patient share HER2+ GC 2L: Good progress Market expansion (Launched in UK, France, Germany (Feb. 2022)) New patient shares increasing (No.1 share in UK, France, Germany) Other progress Other progress Classified as a category 1 preferred regimen for HER2+ BC 2L treatment in NCCN*1 guidelines (Nov. 2021) ESMO Clinical Practice Guideline supported ENHERTU® as the new standard of care for HER2+ BC 2L*2 treatment (Oct. 2021)Japan (HER2+ Breast Cancer 3L, HER2+ Gastric Cancer 3L)ASCA (HER2+ Breast Cancer 3L) Product sales: FY2021 results 9.6 Bn JPY (85 Mn USD) Product sales: FY2021 results 1.4 Bn JPY (12 Mn USD)FY2022 forecast 16.0 Bn JPY (123 Mn USD)FY2022 forecast 6.3 Bn JPY (48 Mn USD) Steady growth in the market New Launch New patient shares increasing (No.1 share in HER2+ BC 3L / GC 3L) Launched in Brazil (Jan. 2022)Underlined part: Update from FY2021 Q3**1 NCCN: National Comprehensive Cancer Network *2 HER2 positive metastatic breast cancer with no, unknown, or stable brain metastasis16Progress towards “Maximize 3ADCs”Progress towards “Profit growth for current business and products”17LIXIANAⓇ: Growth in Each CountryVolumeGlobal revenue FY2021 results: 205.6 Bn JPY (YoY +39.7 Bn JPY)FY2021 forecast: 237.7 Bn JPY (YoY +32.1 Bn JPY)40%35%30%25%20%15%10%5%0%Copyright © 2022 IQVIA. Calculated based on IQVIA MIDAS Data: FY2015 Q2 -FY2021 Q3 Reprinted with permission37.3%31.3%23.9%23.8%19.8%19.2%18.0%14.8%6.7%3.1%0.1%JapanS. KoreaBelgiumTaiwanSpainItalyGermanyUKBrazilChinaUSA18LIXIANAⓇ: Growth in JapanSales No.1 sales share (FY2021 Q4: 39.3%) In August 2021, obtained approval in Japan for additional dosage and administration of “prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation” in elderly patients with high risk of bleeding Revenue FY2021 results: 92.5 Bn JPY (YoY +15.1 Bn JPY), FY2022 forecast: 104.3 Bn JPY (YoY +11.8 Bn JPY)（%）50403020100Decrease in sales share due to drug price revision(special expansion re-pricing)（39.3%）®LIXIANAProduct AProduct BProduct CCopyright © 2022 IQVIA. Calculated based on JPM: FY2014 Q1 -FY2021 Q4 Reprinted with permission19Japan Business: Enhance product portfolio EMGALITYⓇ Prophylaxis of migraine attacks EFIENTⓇ Antiplatelet agent Launched in Apr. 2021 Obtained approval for additional indication *2 in Dec. 2021 LIXIANAⓇ Anticoagulant REYVOWⓇ Migraine treatment Obtained approval for additional dosage and Obtained marketing approval*３ in Jan. 2022 administration*1 in Aug. 2021 DELYTACTⓇ Oncolytic virus G47Δ Launched in Nov. 2021*1 For elderly patients with high risk of bleeding, the dose can be reduced to 15 mg once a day depending on the age and condition of the patient. TARLIGEⓇ Pain treatment Obtained approval for additional indication in Mar. 2022*2 Prevention of recurrence of ischemic cerebrovascular disease following the former appearance of ischemic cerebrovascular disease (associated with large-artery atherosclerosis or small vessel occlusion) (restricted to cases with a high risk of ischemic stroke)*3 Marketing approval was obtained by Eli Lilly Japan which signed an agreement on reverse co-promotion with Daiichi SankyoTARLIGEⓇ: Pain treatment launched in Apr. 2019Obtained approval to change the indication from “peripheral neuropathic pain” to “neuropathic pain” Indication：Neuropathic pain Date of Approval ：Mar. 28, 2022 Increase the contribution to patients with neuropathic pain andmaximize the product value of TARLIGEⓇ by providing a new therapeutic option20Other initiatives in Each RegionEnhance transformation into a profit structure focused on patented drugs Transferred products in JapanJapan Date of Transfer : Nov.-Dec. 2021 Products : 7 products including antihypertensive agent ACECOLⓇ(FY2020 revenue of 7 products: 2.6 Bn JPY）Europe Transferred products in Italy Date of Transfer : May. , Dec. 2021 Products : 3 products including antihypertensive agent LOPRESSORⓇ(FY2020 revenue of 3 products: 0.8 Bn JPY） Concluded an asset sale agreement in US Date of Agreement : Jan. 2022 Products : 8 products including antihypertensive agent BENICARⓇ(FY2021 revenue of 8 products: 8.9 Bn JPY）USASCA Concluded an asset sale agreement in China Date of Agreement : Mar. 2022 Product : Antibacterial agent CravitⓇ(FY2021 Revenue ：8.9 Bn JPY） Subsidiary to be divested：Daiichi Sankyo Pharmaceutical (Beijing) Co., Ltd21Agenda1FY2021 Financial Results2FY2022 Forecast3Business Update4R&D Update55-Year Business Plan Update6Appendix22Progress towards “Maximize 3ADCs”Progress towards “Identify and build pillars for further growth”ASCO 2022News Flow23First year of 5-year business plan: Biggest achievement in R&DENHERTU®: Achievement of two Ph3 study results with a potential to transform treatment for breast cancer patients DESTINY-Breast03 (HER2 positive breast cancer, 2L) DESTINY-Breast04 (HER2 low breast cancer, post chemotherapy)FY2021 marked a major turning point in Daiichi Sankyo’s transformation into a global leader in oncology, and got off to a good start to achieve the 5-year business plan24ENHERTU®: DESTINY-Breast03 studyPrimary endpoint: PFS by BICRESMO 2021Secondary endpoint: PFS by investigator assessmentESMO 2021 72% reduction in risk of disease progression or death compared to ENHERTU® demonstrated 25.1m median PFS while T-DM1T-DM1 demonstrated 7.2m median PFSBICR, blinded independent central review; HR, hazard ratio; mPFS, median progression-free survival; NE, not estimable; NR, not reached; PFS, progression-free survival; T-DM1, trastuzumab emtansine; T-DXd, trastuzumab deruxtecan.Median PFS follow-up for T-DXd was 15.5 months (range, 15.1-16.6) and was 13.9 months (range, 11.8-15.1) for T-DM1.Cortés et al. N Engl J Med. 2022; 286:1143-54 ENHERTU® demonstrated unparalleled improvement in PFS compared to T-DM1 and no grade 4/5 ILD in patients with HER2+ BC, data published in NEJM Regulatory submission accepted in China in Mar 2022, regulatory approval planned in JP/US/EU in FY2022NEJM: the New England Journal of MedicineTransform the course of HER2 positive breast cancer25ENHERTU®: DESTINY-Breast04 studyPh3 study designR2:1Key Eligibility Criteria• HER2-low (IHC 1+ or IHC 2+/ISH-)• Unresectable or metastatic breast cancer • Previously treated with 1 or 2 lines of chemotherapy in the metastatic setting•If HR-positive, must be refractory to endocrine therapy, no restriction on prior targeted therapyBICR: blinded independent central review, HR: hormone receptor, OS: overall survival, PFS: progression free survivalT-DXd 5.4 mg/kgn≈360Investigator’s choicen≈180(Capecitabine, Eribulin, Gemcitabine, Paclitaxel, or Nab-paclitaxel)Primary endpoint• PFS (BICR) in HR+Key Secondary endpoints•••PFS (BICR) HR+ & HR-OS in HR+OS in HR+ & HR- A global Ph3 study in patients with HER2 low breast cancer previously treated with chemotherapy The study met both the primary endpoint and key secondary endpoints: demonstrated a statistically significant and clinically meaningful improvement in both PFS and OS in HR+ patients and patients regardless of HR status Feb 2022: Granted for Real Time Oncology Review (RTOR) by FDA Apr 2022: Granted breakthrough therapy designation by FDA Jun 2022: Data presentation planned at ASCO FY2022 H1: Regulatory submission plannedPioneer HER2 low BC as a new clinically meaningful patient segment26ENHERTU®: DESTINY-Lung01 studyAnti-tumor responses (Best percentage change of tumor size from baseline)ESMO 2021aBest change in tumor size by ICR for 85 of 91 patients for whom baseline and postbaseline data were available. Baseline is last measurement taken before enrollment. bThe Oncomine™ Dx Target Test (Thermo Fisher Scientific) was used to confirm local HER2 mutation status and to determine HER2 amplification status. HER2 protein expression status was determined by immunohistochemistry using a modified PATHWAY anti-HER2 (4B5) (Ventana Medical Systems, Inc.) assay. Shown is best (minimum) percentage change from baseline in the sum of diameters for all target lesions; (-), negative; (+), positive; I, insertion; N, no; S, substitution; Y, yes. Blank cells (except for the prior HER2 TKI therapy row) indicate patients whose tumor samples were not evaluable or assessed. The upper dashed horizontal line indicates a 20% increase in tumor size in the patients who had disease progression and the lower dashed line indicates a 30% decrease in tumor size (partial response). Breakthrough therapy designation granted by FDA in May 2020 Data presented at ESMO 2021 and published in NEJM Regulatory submission accepted and granted Priority Review in US in Apr 2022 (PDUFA date: Aug 16)ENHERTU® to potentially become the first treatment option for HER2 mutated NSCLC27NEJM: the New England Journal of Medicine, NSCLC: non small cell lung cancerENHERTU®: Additional progress in FY2021NeoadjuvantPost-neoadjuvantAdvanced/Metastatic1LAdvanced/Metastatic2LAdvanced/Metastatic3LDESTINY-Breast11Ph3Started in Nov 2021DESTINY-Breast05Ph3Started in Dec 2020DESTINY-Breast09Ph3Started in Jun 2021DESTINY-Breast03Ph3Filing accepted in Dec 2021 (JP/EU)Filing accepted in Jan 2022 (US)Filing accepted in Mar 2022 (CN)DESTINY-Breast01Ph2Launched（JP/US/EU)DESTINY-Breast02Ph3Started in Sep 2018DESTINY-Breast07Ph1b/2 (combo)Started in Jan 2021DESTINY-Gastric03Ph1b/2 (combo)Started in Jun 2020DESTINY-Gastric02Ph2Filing accepted in Nov 2021 (EU)DESTINY-Gastric01Ph2Launched (JP/US*)DESTINY-Gastric04Ph3Started in Jun 2021DESTINY-Gastric06Ph2Started in Sep 2021 (CN)HER2+breastcancerHER2+gastric cancerHER2 mutatedNSCLCNSCLC: non small cell lung cancer, TLR: top line results* Launched in US for 2L indicationStudies which achieved milestones in FY2021, such as study initiation, data acquisition, filing acceptance, etc.Launched indicationDESTINY-Lung02Ph2Started in Mar 2021DESTINY-Lung04Ph3Started in Dec 2021DESTINY-Lung01Ph2Obtained TLR in Jun 2021Development in earlier lines of treatment has progressed in multiple cancer types28Dato-DXd: Progress in FY2021Patients with NSCLC (include both with and without actionable genomic mutations)Patients with TNBC (without prior Topo I inhibitor-based ADC)Efficacy data of TROPION-PanTumor01 studyWCLC 2021SABCS 2021SOD, sum of diameters 6mg/kg dose was selected Efficacy was also confirmed in the subgroup of patients with actionable genomic mutationsa Includes response evaluable patients who had ≥1 postbaseline tumor assessment or discontinued treatment. Postbaseline tumor assessments were not yet available for 1 patient at the data cutoff. b Includes patients with an unconfirmed response but are ongoing treatment. TROPION-Lung08 study (NSCLC without actionable genomic mutations, 1L, Ph3, pembrolizumab combo): started in Mar 2022 TROPION-Breast01 study (HR+/HER2- breast cancer, 2/3L, Ph3): started in Nov 2021 BEGONIA study (TNBC 1L, Ph1b/2, durvalumab combo): started in May 2021 TROPION-PanTumor01 study: added cohorts for gastric, esophageal, urothelial cancer and SCLCHR: hormone receptorNSCLC: non small cell lung cancer SCLC: small cell lung cancerTNBC: triple negative breast cancerDevelopment has progressed in lung and breast cancers. 4 new cohorts were added in TROPION-PanTumor01 study.29HER3-DXd: Progress in FY2021Ph1 efficacy data (EGFR mutated NSCLC cohort)ASCO 2021 HER3-DXd demonstrated tumor responses in patients with NSCLC with multiple EGFR TKI resistance mechanisms in Ph1 study. FDA granted breakthrough therapy designation in Dec 2021. HERTHENA-Lung01 study (EGFR mutated NSCLC 3L, registrational Ph2)is ongoing as scheduled. Ph1b study in combination with osimertinib (EGFR mutated NSCLC, 1/2L) was initiated in Jun 2021. BICR, blinded independent central review; BOR, best overall response; CR, complete response; NE, not evaluable; PD, progressive disease; PR, partial response; SD stable disease; SoD, sum of a Six patients had BORs of NE due to no adequate post-baseline tumor assessment and are not shown; 1 had BOR of NE due to SD too early (< 5 diameters. Data cutoff: September 24, 2020.weeks) and is shown with hatched markings b Genomic alterations known to be associated with EGFR TKI resistance identified in assays of tumor tissue/ctDNA in blood, collected prior to treatment with HER3-DXd. c CDKN2A A143V; PIK3CA E542K, E545K, E726K; ERBB2 K200N; ERBB3 Q847*, Q849*.NSCLC: non small cell lung cancer, TKI: tyrosine kinase inhibitorDevelopment has progressed in EGFR mutated NSCLC. Breakthrough therapy designation was granted by FDA30HER3-DXd: New study plannedHERTHENA-Lung02 study designEGFR mutated NSCLC2nd lineRandomize1:1N = 560HER3-DXdPlatinum-based chemotherapyEndpoints: PFS as well as other endpointsHER3-DXdNSCLCDev. statusEGFR mutated NSCLCAdvanced/Metastatic1LAdvanced/Metastatic2LHERTHENA-Lung02Ph3Study start planned in FY2022 H1Ph1bCombination with osimertinibStarted in Jun 2021Advanced/Metastatic3LHERTHENA-Lung01Registrational Ph2Started in Feb 2021NSCLC: non small cell lung cancer, PFS: progression free survivalPlanning to initiate HERTHENA-Lung02 study (EGFR mutated NSCLC 2L, Ph3）in FY2022 H131Progress towards “Maximize 3ADCs”Progress towards “Identify and build pillars for further growth”ASCO 2022News Flow32Identify new growth drivers following 3ADCs: Rising StarsTarget indicationsDiscoveryPh1Ph2Ph3FiledLaunchedPre-ClinicalRising StarsProject(Target)1ENHERTUⓇ(HER2)Breast, Gastric,NSCLC, CRC, etc.2 Dato-DXd(TROP2)NSCLC, Breast,etc.3 HER3-DXd(HER3)4 DS-7300(B7-H3)5 DS-6000(CDH6)6 DS-3939(TA-MUC1)7 DS-XXXX(Undisclosed)NSCLC, BreastESCC, CRPC, sq-NSCLC, SCLC, etc.Renal,OvarianSolid tumorsUndisclosedTimeline indicates the most advanced stage of each projectCRC: colorectal cancer, CRPC: castration-resistant prostate cancer, ESCC: esophageal squamous cell carcinoma, GIST: gastrointestinal stromal tumor, NSCLC: non small cell lung cancer,. SCLC: small cell lung cancerEarly efficacy signals are being observed in Ph1 of DS-7300 & DS-600033DS-7300: Progress in FY2021Dose escalation interim dataESMO 2021Dose escalation/expansionInterim sub-analysis data in prostate cancerASCO GU 2022Ph1/2 study efficacy data Able to administer up to high dose without severe adverse events Showed promising early clinical activity in heavily pre-treated patients with solid tumors Planning to present follow up data of Ph1/2 study at an upcoming conferenceDS-7300, the fourth DXd-ADC, showed efficacy signal in Ph1.The first clinical data was presented at ESMO34DS-7300: Future development planPh1/2 study designSCLC Ph2 study designDose escalation (Part 1)Dose expansion (Part 2)Advanced/unresectable or metastatic solid tumor• Head and neck squamous cell carcinoma• Esophageal squamous cell carcinoma• Squamous NSCLC• Adenocarcinoma NSCLC• SCLC• Sarcoma• Endometrial cancer• Melanoma• Prostate cancer• Breast cancer• Bladder cancer12.0 mg/kg16.0 mg/kg8.0 mg/kgRDE6.4 mg/kg4.8 mg/kg3.2 mg/kg1.6 mg/kg0.8 mg/kgTumor type changed due to the initiation of SCLC Ph2Cohort 1ESCCCohort 2CRPCSCLC2nd lineRandomize1:1N = 80DS-73008mg/kg DS-730012mg/kg Endpoints: ORR, etc. SCLC was selected based on Ph1 data No effective treatment and high unmet need for SCLC Cohort 3Squamous NSCLC2nd line or later Study start planned in FY2022 H1CRPC: castration-resistant prostate cancer, ESCC: esophageal squamous cell carcinoma, NSCLC: non small cell lung cancer, ORR: objective response rate, SCLC: small cell lung cancerPh2 study is planned for SCLC to determine the optimal dose35DS-6000: Progress in FY2021CDH6 (cadherin 6)Ph1 study design Member of CDH family. The function of CDH6 is still to be fully elucidated. It is said to be related to cell-cell adhesion, epithelial to mesenchymal transition (EMT) and metastasis In developmental stage, CDH6 is expressed in kidney, endometrium, placenta and CNS, and minimal expression in adult normal tissues Highly expressed in renal cell carcinoma and ovarian cancerDose escalation (Part 1)Dose expansion (Part 2)Renal cell carcinomaOvarian cancerDose level 6Dose level 5Dose level 4Dose level 3Dose level 2Dose level 1RDECohort 1Renal cell carcinomaCohort 2Ovarian cancer Ph1 study started in Jan 2021, and dose expansion part is ongoingPlanning to present the first clinical data at ASCO36Select and advance promising post DXd-ADC modalities:Progress of FY2021 Optimized modality High Unmet Medical NeedDaiichi Sankyo’s multi-modality strategyEstablishment of LNP-mRNA technology advanced, built significant knowledge of development and manufacturing.37DS-5670: Progress in FY2021FY2021FY2022H1H2H1H2Ph1/2/3 booster vaccination (JP)Ph1/2 studyDose setting Ph2Establishment of manufacturing system at DS Biotech Development of booster vaccination Ph1/2/3 study started in Jan 2022 Commercialization is expected within CY2022 Development of initial vaccination Ph1/2 study started in Mar 2021, dose setting Ph2 study started in Nov 2021 Ph3 study plan is being continuously discussed with PMDA towards initiation of the study in FY2022 H1Development of COVID-19 vaccine progressed, and preparation for commercialization is ongoing38OncologySpecialty MedicineOther progress in FY2021Virus for cancer treatment DELYTACT ® (Oncolytic virus) Approved in JP for malignant gliomaSmall molecule Valemetostat (EZH1/2 inhibitor) Filed in JP for ATL/L Started registrational Ph2 study for PTCL Started Ph2 study for BCL Quizartinib (FLT3 inhibitor) Obtained TLR of QuANTUM-First study Pexidartinib (CSF-1/KIT/FLT3 inhibitor) DS-1594 (Menin-MLL binding inhibitor) Started Ph1 study for AML/ALLSmall Molecule LIXIANA® (FXa inhibitor) Approved in JP for additional dosage and administration of prevention of stroke, etc. in very elderly patients with atrial fibrillation EFIENT® (ADP receptor inhibitor) Approved in JP for prevention of recurrence of ischemic stroke(restricted to cases with a high risk of ischemic stroke) Approved in JP to change the indication to neuropathic pain TARLIGE® (α2δ ligand)Antibody DS-6016 (Anti-ALK2 antibody) Started single dose Ph1 and obtained data for FOP Started Ph1 for systemic lupus erythematosusVaccine VN-0200 (RS virus vaccine) Started Ph1 study Started Ph2 study in JP for tenosynovial giant cell tumor DS-7011 (Anti-TLR7 antibody)ALL: acute lymphoblastic leukemia, AML: acute myeloid leukemia, ATL/L: adult T-cell leukemia/lymphoma, BCL: B cell lymphoma, PTCL: peripheral T-cell lymphoma, TLR: top line resultsFOP: fibrodysplasia ossificans progressivaConsistently generated outcomes by multi-modality strategy39Progress towards “Maximize 3ADCs”Progress towards “Identify and build pillars for further growth”ASCO 2022News Flow40ASCO Highlights 2022: IR conference callSunao ManabePresident and CEOKen TakeshitaHead of Global R&D Gilles GallantHead of Global Oncology DevelopmentDate and timeJun 8, 2022（Wed）7:30-9:00am JSTMeeting styleVirtual conference by ZoomContent will be delivered on-demand after the meeting.41Progress towards “Maximize 3ADCs”Progress towards “Identify and build pillars for further growth”ASCO 2022News Flow42FY2022 Future News FlowPlanned major publicationsAs of Apr 2022ASCO ( Jun 3-7, 2022)ESMO Breast Cancer (May 3-5, 2022)ENHERTU®DESTINY-Breast07: HER2 positive BC, 1L/2L, Ph1b/2, comboDESTINY-Breast03: HER2 positive BC, 2L, Ph3 DESTINY-Breast04: HER2 low BC, post chemo, Ph3 Safety data updateEfficacy/safety dataInitial efficacy/safety dataInitial efficacy/safety dataDESTINY-Breast08: HER2 low BC, chemo naïve/post chemo, Ph1b, combo•••••HER3-DXdPh1: NSCLCData of cohort with no EGFR mutationsPh1/2: HER3 expressing BCEfficacy/safety data•DS-6000Ph1: Renal cell carcinoma/ovarian cancerInterim data of dose escalation part•BC: breast cancer, EHA: European Hematology Association ENHERTU®Dato-DXd••Ph1b: nivolumab comboHER2 expressing BC cohort dataBEGONIA: TNBC, 1L, Ph1b/2, durvalumab comboInitial efficacy/safety dataEHA ( Jun 9-17, 2022)QuizartinibQuANTUM-First: AML, 1L, Ph3•Efficacy/safety data43FY2022 Future News FlowAs of Apr 2022Regulatory decisionsKey data readoutsDESTINY-Breast02: HER2 positive BC, 3L, Ph3ENHERTU®Dato-DXdDS-5670•••FY2022 H1FY2022 H2FY2022 H2TROPION-Lung01: NSCLC, 2/3L, Ph3Ph1/2/3: COVID-19 mRNA vaccine, boosterDESTINY-Breast03: HER2 positive BC, 2L, Ph3US/EU: FY2022 H1, JP: FY2022 H2•DESTINY-Breast04: HER2 low BC, post chemo, Ph3ENHERTU®DESTINY-Gastric02: HER2 positive GC, 2L, Ph2DESTINY-Lung01: HER2 mutated NSCLC, 2L, Ph2US: FY2022 H2EU: FY2022 H2US: FY2022 H1QuizartinibQuANTUM-First: AML, 1L, Ph3JP/US: FY2022 H2•ValemetostatRegistrational Ph2: R/R ATL/LJP: FY2022 H1•••••••Planned regulatory submissionsPlanned pivotal study initiationHER3-DXd•FY2022 H1HERTHENA-Lung02: EGFR mutated NSCLC, 2L, Ph3ENHERTU®QuizartinibDS-5670DESTINY-Breast04: HER2 low BC, post chemo, Ph3JP/US/EU/CN: FY2022 H1QuANTUM-First: AML, 1L, Ph3JP/US/EU: FY2022 H1Ph1/2/3: COVID-19 mRNA vaccine, boosterJP: FY2022 H2AML: acute myeloid leukemia, ATL/L: adult T-cell leukemia/lymphoma, BC: breast cancer, GC: gastric cancer, NSCLC: non small cell lung cancer, R/R: relapsed/refractory Timeline indicated is based on the current forecast and subject to change.44Agenda1FY2021 Financial Results2FY2022 Forecast3Business Update4R&D Update55-Year Business Plan Update6Appendix45Strategic Pillars for the 5-Year Business Plan (FY2021-FY2025)FY2025Financial TargetsMaximize 3ADCsDato-DXd through strategic alliance with AstraZeneca Maximize HER3-DXd without a partner Expand work force and supply capacity flexibly depending on changes around product potentialAchieve FY2025 Target and Shift to Further Growth Revenue: 1.6 Tr JPY (Oncology > 600.0 Bn JPY) Core Operating Profit Ratio before R&D Expense: 40％ ROE > 16% DOE* > 8%Profit growth for current business and productsIdentify and build pillars for further growthCreate shared value with stakeholders Maximize ENHERTUⓇ and Maximize LixianaⓇ profit Identify new growth drivers following 3ADCs Select and advance promising post DXd-ADC modalities Grow TarligeⓇ, NilemdoⓇ, etc. quickly Transform to profit structure focused on patented drugs Profit growth for American Regent and Daiichi Sankyo Healthcare Patients: Contributing to patients through “Patient Centric Mindset“ Shareholders: Balanced investment for growth and shareholder returns Society: Environment load reduction across the value chain, and actions against pandemic risks Employees: Create one DS culture through fostering our core behaviors Data-driven management through DX, and company-wide transformation through advanced digital technology Agile decision making through new global management structure*DOE: Dividend on Equity = Total dividend amount / Equity attributable to owners of the company465-Year Business Plan: Progress in the First YearSteady progress in each initiative especially for “Maximize 3ADCs”Maximize 3ADCsIdentify and build pillars for further growth ENHERTU®: Increase of product value DB-03 (HER2+ BC 2L): achieve primary endpoints and submit in each region Emerging new growth drivers (Rising Stars) following 3ADCs Increase of product potential for DS-7300 (B7-H3 ADC) andDS-6000 (CDH6 ADC) by progresses of development DB-04 (HER2-low BC post-chemo): achieve primary endpoints Steady revenue increase in each region Advancement to select post DXd-ADC modalities Progress of technology establishment for LNP-mRNA Dato-DXd, HER3-DXd: Progress of developmentProfit growth for current business and productsCreate shared value with stakeholders Growth of current products Progress initiative for environmental issues Steady revenue increases of Lixiana®, Injectafer, Tarlige®, Joined RE100, a global initiative aiming to use 100% renewable Nilemdo® and othersenergy for electricity consumed in business activities Strengthening to transform business structure focused on Actions against pandemic riskspatented drugs Progress of transformation by product divesture in each region DS-5670 (COVID-19 mRNA vaccine): Progress of development prioritizing booster injection47Agenda1FY2021 Financial Results2FY2022 Forecast3Business Update4R&D Update55-Year Business Plan Update6Appendix48Major R&D Milestones (3ADCs)As of Apr 2022ENHERTU®ProjectTarget Indications [phase, study name]HER2+, 3L [P3, DESTINY-Breast02]HER2+, 2L [P3, DESTINY-Breast03]BCGCHER2 low, post chemo[P3, DESTINY-Breast04]HER2 low, chemo naive[P3, DESTINY-Breast06]HER2+, 2L [P2, DESTINY-Gastric02、EU]HER2 mutated, 2L [P2, DESTINY-Lung01]NSCLCHER2 mutated, 2L [P2, DESTINY-Lung05, CN]2/3L [P3, TROPION-Lung01]FY2021Q4Filing accepted(CN)TLR obtainedH1TLR anticipatedApproval anticipated (US/EU)Filing anticipated (JP/US/EU/CN)FY2022H2FY2023Approval anticipated (JP)Approval anticipated (US)Approval anticipated (JP/EU)Approval anticipated (EU)TLR anticipatedFiling accepted (US)Approval anticipated (US)Study start plannedTLR anticipatedDato-DXdNSCLCw/o actionable genomic mutations, 1L, pembrolizumab combo [P3, TROPION-Lung08]Study startedEGFR mutated, 3L[Registrational P2, HERTHENA-Lung01]HER3-DXd NSCLCEGFR mutated, 2L[P3, HERTHENA-Lung02]Study start plannedRed underlined: new or updated from FY2021 Q3BC: breast cancer, GC: gastric cancer, NSCLC: non small cell lung cancer, TLR: top line resultsThe timeline indicated is based on the current forecast and subject to change.TLR anticipated49Major R&D Milestones (Alpha)As of Apr 2022ProjectTarget Indications [phase, study name, region]FY2021Q4FY2022H1H2FY2023DS-7300SCLC, 2L [P2, JP/US/EU/Asia]QuizartinibAML, 1L [P3, JP/US/EU/Asia]Valemetostat（DS-3201）TARLIGE®ATL/L [Registrational P2, JP]Central neuropathic pain [P3, JP]DS-7011Systemic lupus erythematosus [P1, US]Study start plannedFiling anticipated(JP/US/EU)Approval anticipated（JP）Approved（JP）Study startedDS-5670COVID-19 mRNA vaccine, booster [P1/2/3, JP]Study startedTLR anticipatedFiling anticipated（JP）Approval anticipated(JP/US)Approval anticipated(EU)Red underlined: new or updated from FY2021 Q3 TLR: Top Line ResultsThe timeline indicated is based on the current forecast and subject to change.50Major R&D Pipeline: 3ADCsPhase 1Phase 2Phase 3FiledAs of Apr 2022(US/EU/Asia) TNBC (durvalumab combo)BEGONIA(China) HER2+ GC 3L DESTINY-Gastric06(JP/US/EU/Asia)HER2+ BC 3LDESTINY-Breast02(JP/US/EU/Asia) HER2+ BC 2L DESTINY-Breast03 (JP/US/EU/Asia) HER2 low BCpost chemoDESTINY-Breast04(EU) HER2+ GC 2L DESTINY-Gastric02(JP/US/EU)HER2+/mutated NSCLC 2L~DESTINY-Lung01 (JP/US/EU/Asia) HER2+ BC post neoadjuvantDESTINY-Breast05(US) HER2 mutated NSCLC 2L~DESTINY-Lung01 (US/EU/Asia) HER2+ BC 2L~/1LDESTINY-Breast07(US/EU/Asia) HER2 low BC chemo naïve/ post chemoDESTINY-Breast08(JP/US/EU/Asia) HER2+ GC combo, 2L~/1LDESTINY-Gastric03(EU/Asia)HER2+ NSCLC (durvalumab combo) 1LDESTINY-Lung03(US/EU) BC, bladder (nivolumab combo)(US/EU) BC, NSCLC (pembrolizumab combo)(US/EU/Asia) solid tumors (AZD5305 combo)PETRA(JP/US) NSCLC, TNBC, HR+ BC, SCLC, urothelial, GC, esophagealTROPION-PanTumor01(JP/US/EU/Asia) NSCLC (w/o actionable mutation, pembrolizumab combo)TROPION-Lung02(JP/US/EU) NSCLC (w/o actionable mutation, durvalumab combo)TROPION-Lung04(US/EU/Asia) TNBC (durvalumab combo)BEGONIA(JP/US/EU/Asia) solid tumors (AZD5305 combo) PETRA(JP/US/EU/Asia) NSCLC(JP/US)EGFR mutated NSCLC (osimertinib combo)(JP/US) HER3+ BCENHERTUⓇDato-DXdHER3-DXd(JP/US/EU/Asia) HER2 mutated NSCLC 2L~DESTINY-Lung02(CN) HER2 mutated NSCLC 2L~ DESTINY-Lung05(JP/US/EU/Asia) HER2 low BC chemo naiveDESTINY-Breast06(JP/US/EU/Asia)HER2+ BC 1LDESTINY-Breast09(US/EU/Asia) NSCLC(durvalumab combo) 2L~HUDSON(JP/US/EU) HER2+ CRC 3LDESTINY-CRC01(JP/US/EU/Asia) HER2+ CRC 3LDESTINY-CRC02(JP/US/EU/Asia) HER2 mutated tumorDESTINY-PanTumor01(US/EU/Asia) HER2 expressing tumorDESTINY-PanTumor02(JP/US/EU/Asia) NSCLC (w/ actionable mutation) TROPION-Lung05(JP/US/EU/Asia) HER2+ BC neoadjuvantDESTINY-Breast11(JP/EU/Asia) HER2+ GC 2LDESTINY-Gastric04(JP/US/EU/Asia) NSCLC 1L(w/ exon 19 or exon 20 mutation) DESTINY-Lung04(JP/US/EU/Asia) NSCLC 2/3LTROPION-Lung01(JP/US/EU/Asia) HR+ BC 2/3LTROPION-Breast01(JP/US/EU/Asia) NSCLC (w/o actionable mutation, pembro combo)TROPION-Lung08(JP/US/EU/Asia) EGFR mutated NSCLC 3L HERTHENA-Lung01(JP/US/EU/Asia) EGFR mutated NSCLC 2L HERTHENA-Lung02BC: breast cancer, CRC: colorectal cancer,GC: gastric cancer, NSCLC: non-small celllung cancer, SCLC: small cell lung cancer,TNBC: triple negative breast cancer□: project in oncology that is planned tobe submitted for approval based onthe results of phase 2 trials : Breakthrough Designation (US)51Major R&D Pipeline: AlphaDS-7300 (JP/US)B7-H3-directed ADCESCC, CRPC, squamous NSCLC, etc.PLX2853 (US)BET inhibitor AMLPhase 1DS-6000 (US)CDH6-directed ADC Renal cell carcinoma, ovarian cancerDS-1055 (JP/US)Anti-GARP antibodySolid tumorsDS-1211 (US)TNAP inhibitorPseudoxanthoma elasticumPLX2853 (US)BET inhibitor Solid tumorPLX2853 (US)BET inhibitor Gynecologic neoplasms, ovarian cancerPLX2853 (US)BET inhibitor Prostate cancerPhase 2Valemetostat (DS-3201)(JP/US/EU/Asia)EZH1/2 inhibitorPTCLValemetostat (DS-3201) (EU)EZH1/2 inhibitorBCLDS-1001 (JP) Mutant IDH1 inhibitorGliomaDS-7300 (JP/US/EU/Asia)B7-H3-directed ADCSCLCDS-6016 (JP)Anti-ALK2 antibodyFibrodysplasia ossificans progressiva DS-1594 (US)Menin-MLL binding inhibitorAML, ALLDS-5141 (JP)ENA oligonucleotide DMDDS-7011 (US)Anti-TLR7 antibodySystemic lupus erythematosus VN-0200 (JP)RS virus vaccineRS virus infectionDS-5670 (JP)SARS-CoV-2 mRNA vaccineCOVID-19 (initial vaccination)As of Apr 2022Phase 3Quizartinib (JP/US/EU/Asia)FLT3 inhibitor1L AMLFiledValemetostat (DS-3201) (JP)EZH1/2 inhibitorATL/LVN-0107/MEDI3250 (JP)Live attenuated influenza vaccine nasal sprayPexidartinib (JP/Asia)CSF-1/KIT/FLT3 inhibitorTenosynovial giant cell tumorMinnebro (JP)MR blockerDiabetic nephropathyVN-0102/JVC-001 (JP)Measles mumps rubella combined vaccineDS-5670 (JP)SARS-CoV-2 mRNA vaccineCOVID-19 (booster vaccination)OncologySpecialty medicineVaccineALL: acute lymphoblastic leukemia, AML: acute myeloid leukemia, ATL/L: adult T-cell leukemia/lymphoma, BCL: B cell lymphoma, CRPC: castration-resistant prostate cancer, DMD: Duchenne muscular dystrophy, ESCC: esophageal squamous cell carcinoma, FOP: Fibrodysplasia ossificans progressive, LBCL: large B cell lymphoma, NSCLC: non small cell lung cancer, SCLC: small cell lung cancer, PTCL: peripheral T-cell lymphoma□: project in oncology that is planned to be submitted for approval based on the results of phase 2 trials : SAKIGAKE Designation (JP) Orphan drug designation (JP/US/Europe)52Contact address regarding this materialDaiichi Sankyo Co., Ltd.Corporate Communications DepartmentTEL: +81-3-6225-1125Email: DaiichiSankyoIR@daiichisankyo.co.jp53