FY2020 Q4 Financial Results Presentation E
FY2020Financial Results PresentationDAIICHI SANKYO CO., LTD.Sunao ManabePresident and CEOApril 27, 2021
Forward-Looking StatementsManagement strategies and plans, financial forecasts, future projections and policies, and R&D information that Daiichi Sankyo discloses inthis material are all classified as Daiichi Sankyo’s future prospects. These forward looking statements were determined by Daiichi Sankyobased on information obtained as of today with certain assumptions, premises and future forecasts, and thus, there are various inherent risksas well as uncertainties involved. As such, please note that actual results of Daiichi Sankyo may diverge materially from Daiichi Sankyo’soutlook or the content of this material. Furthermore, there is no assurance that any forward-looking statements in this material will berealized. Regardless of the actual results or facts, Daiichi Sankyo is not obliged and does not have in its policy the duty to update the contentof 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. Thereare 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 absoluteaccuracy, appropriateness, completeness and feasibility, etc. of the information described in this material. Furthermore, any informationregarding companies, organizations or any other matters outside the Daiichi Sankyo Group that is described within this material has beencompiled or cited using publicly available information or other information, and Daiichi Sankyo has not performed in-house inspection of theaccuracy, 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 describedherein 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 limitationdamages related to the use of erroneous information.
Agenda1FY2020 Financial Results2FY2021 Forecast3Business Update4R&D Update5Actions against COVID-19 Update6Appendix3
Overview of FY2020 Results(Bn JPY)RevenueFY2019 YTDFY2020 YTDResultsResultsYoY-2.0%981.8962.5Cost of sales343.2338.3-4.9SG&A expenses302.3333.130.8R&D expenses197.5227.429.9Operating Profit138.863.8Profit before tax141.274.1129.176.0Profit attributable toowners of the /JPY108.75106.06-2.69RateEUR/JPY120.83123.70 2.874
RevenueDecreased by 19.3 Bn JPY (Decreased by 14.0 Bn JPY excl. forex impact)(Bn JPY)Positive Vaccines,DaiichiSankyo,Inc.DaiichiSankyo, Inc.(US)16.5(US)AmericanRegentAmerican Regent(US)0.00.013.6Daiichi Sankyo EuropeDaiichi Sankyo EuropeAsia, South and CentralASCAEnhertu, Dato-DXd*10.06.6DS-8201/DS-1062Upfront Payment &Regulatory Milestone0.0Forex 7America (ASCA)(Asia, South and Central America)Forex0.06.0(US)Daiichi Sankyo Espha5.3910.0Positive890.0Factors870.0*1 Dato-DXd: Datopotamab deruxtecan (DS-1062)*2 Forex impact USD: -4.5, EUR : 2.6, ASCA: -3.4930.0950.0970.0NegativeFactors 12.6 4.4MemaryInavirLixiana-32.1-15.6-5.6 10.9Vaccines business-17.1Memantine AG, Ezetimibe AG etc.ActHIBDaiichi Sankyo 3.6LuluDaiichi Sankyo, Inc. (US)Enhertu 23.2American Regent (US)0.0Daiichi Sankyo EuropeLixianaGain on sales of transferringlong-listed products962.5Negative Factors 13.2 4.5Enhertu, Dato-DXd*1 Upfront Payment & Regulatory MilestoneDato-DXd upfront payment 3.9Enhertu Regulatory Milestone 2.65
Operating ProfitDecreased by 75.0 Bn JPY(Decreased by 46.3 Bn JPY excl. forex impact and special items)(Bn JPY)RevenueRevenueRevenue5.228.70.00.063.850.0 Positive70.0Factors 90.0 15.4 (Profit decreased)Increase in Enhertu related expenses(including sales promotion expenses and profit share with AstraZeneca)0.032.2ForexImpactForexImpact30.0SG&A Expenses0.0 15.4R&DExpensesR&DExpenses-15.3 (Profit increased)Decrease by revenue decrease19.30.0 ultsCost of temsincl. forex impact of ‐5.3138.8FY2019ResultsFY2019Results‐19.3R&D Expenses Increase in 3ADCs* R&D investments Increase due to oncology development structure enhancementForex ImpactCost of SalesSG&A ExpensesR&D ExpensesSpecial Items110.0 Factors130.0Negative 32.2 (Profit decreased)-5.2 (Profit increased)-0.8-2.1-2.3 28.7 (Profit decreased)See next slide for details* 3ADCs: 1) Enhertu, Trastuzumab deruxtecan (T-DXd, DS-8201), 2) Datopotamab deruxtecan (Dato-DXd, DS-1062)and 3) Patritumab deruxtecan (HER3-DXd, U3-1402)6
Special Items(Bn JPY)FY2019 YTDFY2020 YTDResultsResultsRestructuring costs in SCCost of salesSG&A expensesImpairment loss*1(intangible assets)1.3-18.8Gain on sales of fixed assets *3-10.6Environmental expenditures*48.2Total*1 Morphabond, Roxybond, Zelboraf*2 Takatsuki Plant*3 Nihonbashi Building*4 Former Yasugawa Plant-6.3Gain on sales of subsidiary*2R&D expensesYoYVaccine business losscompensation15.011.217.4----13.715.028.7Booked in Q4Special items :Items having a transitory and material impact on operating profit are defined as “Special items”. Specifically, gains and losses related to: sale of fixedassets, restructuring, impairment, litigation, etc. amounting to 1 billion JPY or more are defined as "Special items".7
Profit Attributable to Owners of the CompanyDecreased by 53.1 Bn JPY(Bn JPY)Financial Income / Expenses ofitOperatingProfit0.0 Recognition of financial income due todecrease in contingent considerationof Ambit/quizartinib acquisition Improvement in forex gains/lossesIncome Taxes etc.Financial IncomeFinancialIncome// ExpensesExpensesetc.8.113.9Income Taxes etc.Income Taxes etc.0.00.0Income Taxes etc.Tax rateFY2020ResultsFY2020Results76.00.020.0 rs-4.7-3.6-13.9 (Profit increased)FY2019Profit before Tax-8.1 (Profit 6%-2.3%-（参考：税率）(Reference: Tax rate)FY2019: Impact of introduction of consolidated taxation systemFY2020: Decrease in Income taxes due to an increase in DTAattributable to future expected taxable income increaseof 3ADCs8
Revenue: Major Business Units (incl. Forex Impact)(Bn JPY)FY2019 YTDFY2020 YTDResultsResultsYoY533.5489.1-44.4Daiichi Sankyo Healthcare68.567.2-1.3Daiichi Sankyo, Inc.32.147.4 15.3Enhertu3.225.7 7-9.1Injectafer51.844.1-7.7Venofer31.028.8-2.2GE injectables41.241.8 0.695.5111.7 16.1Lixiana61.776.7 15.0Olmesartan24.621.5-3.12.51.6-0.998.399.7 1.3108.75120.83106.06123.70-2.69 2.87JapanAmerican Regent, Inc.Daiichi Sankyo EuropeEfientASCA (Asia, South and Central America)CurrencyUSD/JPYRateEUR/JPY9
Revenue: Major Products in Japan(Bn JPY)FY2019 YTDResultsFY2020 YTDResultsYoYNexiumulcer 5.6Praliatreatment for osteoporosis/ inhibitor of the progression ofbone erosion associated with rheumatoid arthritis30.934.6 3.7MemaryAlzheimer’s disease treatment50.518.4-32.1Teneliatype 2 diabetes mellitus treatment24.724.2-0.5Loxoninanti-inflammatory analgesic28.324.2-4.1Ranmarktreatment for bone complications caused by bone metastasesfrom tumors17.919.3 1.4Inaviranti-influenza agent19.33.6-15.6Tarligepain treatment8.020.6 12.6Canaliatype 2 diabetes mellitus treatment12.815.4 2.6Vimpatanti-epileptic agent11.214.5 3.4Efientantiplatelet agent14.014.1 0.1Rezaltasantihypertensive agent14.613.1-1.5Olmetecantihypertensive agent11.79.2-2.4Enhertuanti-cancer agent(HER2-directed antibody drug conjugate)-4.4 4.410
1FY2020 Financial Results2FY2021 Forecast3Business Update4R&D Update5Actions against COVID-19 Update6Appendix11
ENHERTU : Revenue（Bn JPY）FY2020FY2021ResultsForecast Reference TotalYoYConsiderationProduct Sales30.169.4 39.3-Japan4.413.4 9.0-25.750.4 24.7-0.05.4 5.4--0.2 0.2--149.0 1.334.6USEuropeASCAUpfront payment9.8 *Regulatory milestone payment3.51*19.8 *4.81*1US HER2 Breast Cancer 3L0.90.9-13.7EU HER2 Breast Cancer 3L1.00.5-0.57.9US HER2 Gastric Cancer 2L 3L1.60.8-0.812.1-2.6 2.643.584.0 40.6US HER2 or HER2 Mutant NSCLC 2LTotal*1 Revenue recognized in each period*2 Expected consideration based on the assumption of achieving milestones in FY202113.1 *2183.616
ENHERTUInitiatives for Business Growth in Each RegionEDOXABANStreamlining AssetsShareholder Returns17
Initiatives for Business Growth in Each RegionInitiatives to strengthen the product portfolio and maximize product value areprogressing steadilyJapan Prophylaxis of migraine attacksEMGALITY Launched in Apr. 2021 Treatment for large B cell lymphomaYESCARTA Approved in Jan. 2021,Listed in NHI price listing in Apr. 2021 Anti-epileptic agentVIMPAT New indication* approved in Dec. 2020*1 Combination therapy for tonic-clonic seizure in patients with epilepsyEurope Cholesterol lowering treatmentNILEMDO and NUSTENDI Launched in Nov. 2020ASCA*2 AnticoagulantLIXIANA (里先安 ) Listed in National Reimbursement Drug List(NRDL) in China in Dec. 2020 (Applied fromMar. 2021)*2 Asia, South & Central America18
ENHERTUInitiatives for Business Growth in Each RegionEDOXABANStreamlining AssetsShareholder Returns19
LIXIANA : Growth in JapanSales No.1 sales share (FY2020 Q4: 35.0%) Revenue FY2020 results: 77.4 Bn JPY (YoY ‐5.6 Bn JPY, Previous drug price base YoY 20.2 Bn JPY)FY2021 forecast: 90.4 Bn JPY (YoY 13.0 Bn JPY)（%）50Decrease in sales share due todrug price revision(special expansion re-pricing)4035.0%3020LIXIANAProduct A10Product BProduct C0Copyright 2021 IQVIA.Calculated based on JPM: FY2014 Q1 -FY2020 Q4 Reprinted with permission20
EDOXABAN: Growth in Each CountryVolumeGlobal revenue FY2020 results: 165.9 Bn JPY (YoY 11.9 Bn JPY)FY2021 forecast: 188.4 Bn JPY (YoY 22.4 Bn JPY)40%35%30%25%20%15%10%33.8%Japan32.4%S. rmany13.5%UKItaly5%6.9%Brazil0%0.1%USACopyright 2021 IQVIA.C020*1 JPLaunched in May 2020*2 EUApproved in January 2021*3Launched in February 2021 UKApproved in February 2021*3GastricHER2 Gastric Cancer3rd Line JPApproved in September 2020*4HER2 Gastric Cancer2nd Line USApproved in January 2021*5Underline: Progress in FY2020*1 Treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti HER2 based regimens in the metastatic setting*2 Treatment of patients with HER2 positive unresectable or recurrent breast cancer after prior chemotherapy (limit the use to patients who are refractory or intolerant to standard treatments)*3 Treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti HER2 based regimens*4 Treatment of patients with HER2 positive unresectable advanced or recurrent gastric cancer that has progressed after chemo therapy*5 Treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab based regimen 15
ENHERTU : Revenue（Bn JPY）FY2020FY2021ResultsForecast Reference TotalYoYConsiderationProduct Sales30.169.4 39.3-Japan4.413.4 9.0-25.750.4 24.7-0.05.4 5.4--0.2 0.2--149.0 1.334.6USEuropeASCAUpfront payment9.8 *Regulatory milestone payment3.51*19.8 *4.81*1US HER2 Breast Cancer 3L0.90.9-13.7EU HER2 Breast Cancer 3L1.00.5-0.57.9US HER2 Gastric Cancer 2L 3L1.60.8-0.812.1-2.6 2.643.584.0 40.6US HER2 or HER2 Mutant NSCLC 2LTotal*1 Revenue recognized in each period*2 Expected consideration based on the assumption of achieving milestones in FY202113.1 *2183.616
ENHERTUInitiatives for Business Growth in Each RegionEDOXABANStreamlining AssetsShareholder Returns17
Initiatives for Business Growth in Each RegionInitiatives to strengthen the product portfolio and maximize product value areprogressing steadilyJapan Prophylaxis of migraine attacksEMGALITY Launched in Apr. 2021 Treatment for large B cell lymphomaYESCARTA Approved in Jan. 2021,Listed in NHI price listing in Apr. 2021 Anti-epileptic agentVIMPAT New indication* approved in Dec. 2020*1 Combination therapy for tonic-clonic seizure in patients with epilepsyEurope Cholesterol lowering treatmentNILEMDO and NUSTENDI Launched in Nov. 2020ASCA*2 AnticoagulantLIXIANA (里先安 ) Listed in National Reimbursement Drug List(NRDL) in China in Dec. 2020 (Applied fromMar. 2021)*2 Asia, South & Central America18
ENHERTUInitiatives for Business Growth in Each RegionEDOXABANStreamlining AssetsShareholder Returns19
LIXIANA : Growth in JapanSales No.1 sales share (FY2020 Q4: 35.0%) Revenue FY2020 results: 77.4 Bn JPY (YoY ‐5.6 Bn JPY, Previous drug price base YoY 20.2 Bn JPY)FY2021 forecast: 90.4 Bn JPY (YoY 13.0 Bn JPY)（%）50Decrease in sales share due todrug price revision(special expansion re-pricing)4035.0%3020LIXIANAProduct A10Product BProduct C0Copyright 2021 IQVIA.Calculated based on JPM: FY2014 Q1 -FY2020 Q4 Reprinted with permission20
EDOXABAN: Growth in Each CountryVolumeGlobal revenue FY2020 results: 165.9 Bn JPY (YoY 11.9 Bn JPY)FY2021 forecast: 188.4 Bn JPY (YoY 22.4 Bn JPY)40%35%30%25%20%15%10%33.8%Japan32.4%S. rmany13.5%UKItaly5%6.9%Brazil0%0.1%USACopyright 2021 IQVIA.Calculated based on MIDAS Data: FY2015 Q2 -FY2021 Q3 Reprinted with permission21
ENHERTUInitiatives for Business Growth in Each RegionEDOXABANStreamlining AssetsShareholder Returns22
Cash Generation by Streamlining AssetsDuring the 5-Year Business Plan period (FY2016 -FY2020), generated cash of163.2 Bn JPY by streamlining assetsReduce crossshareholdingsharesSale ofpropertiesGain on salesof 7.3 Bn JPY14.4 Bn JPY14.3 Bn JPY22.0 Bn JPY2.5 Bn JPY70.5 Bn JPYGain onsales*19.3 Bn JPY9.8 Bn JPY10.6 Bn JPY14.4 Bn JPY1.1 Bn JPY45.3 Bn JPYSalesproceeds3.2 Bn JPY10.7 Bn JPY11.0 Bn JPY14.0 Bn JPY0.3 Bn JPY39.2 Bn JPYGain onsales0.8 Bn JPY7.6 Bn JPY9.0 Bn JPY10.7 Bn JPY0.1 Bn JPY28.1 Bn JPYSalesproceeds1.5 Bn JPY-10.4 Bn JPY37.1 Bn JPY4.5 Bn JPY53.5 Bn JPYGain onsales0.1 Bn JPY*2-6.3 Bn JPY*319.1 Bn JPY*45.9 Bn JPY*531.3 Bn JPY(# of Brands)(14 Brands)(9 Brands)(10 Brands)(12 Brands)(6 Brands)*1 Booked in other comprehensive income *2 Bethlehem plant in US *3 Long-listed products (JP) *4 Takatsuki plant, Long-listed products (JP)*5 Long-listed products (JP/EU)(51 Brands)23
ENHERTUInitiatives for Business Growth in Each RegionEDOXABANStreamlining AssetsShareholder Returns24
Shareholder Returns By dividends increase and own shares acquisition, achieved total return ratio of 105.6%for the 5-year business plan period (FY2016 – FY2020) Cancelled own shares in April 2021Dividends Dividend per share for FY2020 (Pre-split base*1): 81 JPY (vs FY2019: 11 JPY increase)Acquisitionof ownshares Acquisition period: November 2, 2020 – March 12, 2021 Aggregate amount of acquisition cost: 100.0 Bn JPY Total number of shares acquired: 29.47 Mn sharesCancellationof ownshares Cancellation date: April 15, 2021 Number of shares cancelled: 180 Mn shares(Cancelled except for the number of shares to be used for stock option and restricted share-based remuneration)ref. ratio of own shares to total number of issued shares after cancellation 1.6%Total return ratio during the 5-year business plan period (FY2016 - FY2020)Dividend per share*1Acquisition of own sharesTotal return ratio*2FY2016 ResultsFY2017 ResultsFY2018 ResultsFY2019 ResultsFY2020 Results70 JPY70 JPY70 JPY70 JPY81 JPY50.0 Bn JPY50.0 Bn JPY--100.0 Bn JPY180.7%159.1%48.5%35.1%200.3%105.6%＊１ Pre-split base (Share split, three-for-one (effective date: Oct. 1, 2020))＊２ Total return ratio (Dividends Total acquisition costs of own shares) / Profit attributable to owners of the company25
1FY2020 Financial Results2FY2021 Forecast3Business Update4R&D Update5Update of Actions against COVID-196Appendix26
Major progress in FY2020ASCO 2021News Flow27
3ADCs: Major Progress of Enhertu in FY2020HER2positiveBC Started DESTINY-Breast05 study (post neoadjuvant, Ph3),among high risk, early breast cancer patients Started DESTINY-Breast07 study (1/2L, Ph1b/2, combo),a fundamental study for development in earlier treatment lines HER2 lowBCStarted DESTINY-Breast06 & DESTINY-Breast08 studiesaiming for earlier treatment lines DESTINY-Breast06: chemo naive, Ph3 DESTINY-Breast08: chemo naive/post chemo, Ph1b, comboHER2negativeBC Newly added Enhertu cohort in AstraZeneca-ledBEGONIA study (TNBC, 1L, Ph1b/2, durvalumab combo)BC: breast cancer, TNBC: triple negative breast cancerStarted 5 studies including earlier treatment lines,regardless of HER2 expression level28
3ADCs: Major Progress of Enhertu in FY2020GCNSCLCOthercancers Started DESTINY-Gastric03 study (1/2L, Ph1b/2, combo),a fundamental study for development in early treatment lines Started DESTINY-Lung02 study (HER2 mutated NSCLC, 2L , Ph2) for furtherevaluation of dose (5.4mg/kg) Newly added Enhertu cohort in AstraZeneca-lead HUDSON study(NSCLC, 2L , Ph2, durvalumab combo) Started DESTINY-CRC02 study (HER2 CRC, 3L, Ph2) for further dataaccumulation and confirmation of optimal dose (5.4 or 6.4mg/kg) Started two basket studies, DESTINY-PanTumor01 & DESTINY-PanTumor02studies, for further expansion of cancer types DESTINY-PanTumor01: HER2 mutated cancers, Ph2 DESTINY-PanTumor02: HER2 expressing cancers, Ph2GC: gastric cancer, NSCLC: non-small cell lung cancerStarted 6 studies in broad cancer types,also aiming for earlier treatment lines29
3ADCs: Major Progress of Dato-DXd in FY2020NSCLC(w/o actionablemutation) Started TROPION-Lung01 study (2/3L, global Ph3),the first pivotal study for Dato-DXd Started TROPION-Lung02 & TROPION-Lung04 studiesaiming for earlier treatment lines (1/2L) TROPION-Lung02: Ph1, pembrolizumab combo Pt chemo TROPION-Lung04: Ph1, durvalumab combo Pt chemoNSCLC(w/ actionablemutation) Started TROPION-Lung05 study (3L, global Ph2)HER2 negative Newly added two cohorts (TNBC & HR ) in TROPIONBCPanTumor01 study. Enrollment of TNBC cohort is completed.NSCLC: non-small cell lung cancer, TNBC: triple negative breast cancerSignificant progress in the development of NSCLC and TNBC,also aiming for earlier treatment lines30
3ADCs: Major Progress of HER3-DXd in FY2020 NSCLCStarted HERTHENA-Lung01 study,the first pivotal study for HER3-DXd EGFR mutated NSCLC 3L, pivotal global Ph2 Started preparation for Ph1 study in combination withosimertinib, aiming for earlier treatment lines EGFR mutated NSCLC 1/2L, global Ph1CRC Started global Ph2 study in CRC 3LCRC：colorectal cancer, NSCLC: non-small cell lung cancerSignificant progress in the development of EGFR mutated NSCLC,also progress in other cancer types31
3ADCs: Major presentations at conferences in FY2020ASCOEnhertu DESTINY-Lung01(HER2 mt NSCLC, 2L, Ph2)ESMOEnhertuEnhertu DESTINY-Gastric01(HER2 positive BC, 3L, Ph2)(HER2 positive GC, 3L, Ph2） DESTINY-Gastric01HER2 low exploratory cohort(HER2 positive GC, 3L, Ph2)HER3-DXd DESTINY-CRC01(HER2 positive CRC, 3L, Ph2) EGFR mt NSCLC, Ph1Dato-DXd TROPION-PanTumor01(NSCLC cohort, Ph1)SABCS DESTINY-Breast01 HER2 positive BC,Ph1, nivolumabcomboWCLCEnhertu DESTINY-Lung01(HER2 overexpressing NSCLC,2L,Ph2)Dato-DXd TROPION-PanTumor01HER3-DXd(NSCLC cohort, Ph1) BC, Ph1/2 EGFR mt NSCLC, Ph1HER3-DXdThe number of presentations exceeded FY2019,reflecting the progress of developmentBC: breast cancer, CRC: colorectal cancer, GC: gastric cancer, NSCLC: non-small cell lung cancer32
ASCO 2021 Advance of the YearDESTINY-Gastric01 data @ASCO 2020DESTINY-CRC01 data @ASCO 2020Best % Change from BaselineEvents/nMedianT-DXd62/12512.5 monthsPhysician’schoice39/62HR(95% CI, 9.6-14.3)8.4 months(95% CI, 6.9-10.7)0.59 (95% CI, 0.39-0.88)Enhertu DESTINY-Gastric01/CRC01 data were selected asASCO 2021 Advance of the Year33
Enhertu received the Japanese Prime Minister’s AwardAward Ceremony of the 9th Technology Management and Innovation AwardsThe award was given in high recognition of the following:1.The creation of Enhertu based on the many years of knowledge and experience of new drug research & development.2.Establishment of management system that enabled rapid decision making, which accelerated research and development.3.The efforts toward the speedy acquisition of data that meet global standards to secure regulatory approvals throughcollaboration with academic and medical institutions.4.The positive use of the new regulatory pathways for exploring new and innovative ways to deliver Enhertu to patients asquickly as possible.5.The development of a successful manufacturing method to minimize quality issues of the product.34
Alpha: Major Progress in FY2020OncologyOncolytic Virus DS-1647/G47ΔNDA submission (JP)DXd-ADC DS-6157 (GPR20) Ph1 start DS-6000 (CDH6) Ph1 startAntibody（Immuno-oncology） DS-1055 (GARP) Ph1 startSpecialty MedicineSmall Molecule Lixiana Atrial fibrillation in the very elderlysNDA submission (JP) Efient Ischemic stroke sNDA submission (JP) Tarlige Central neuropathic painTLR obtained from Ph3 studyENA oligonucleotide DS-5141Duchenne muscular dystrophyTLR obtained from Ph1/2 studyDevelopment of various modalities has progressed35
Major progress in FY2020ASCO 2021News Flow36
Planned Presentation at ASCO 2021（6/4 to 6/8, Virtual Meeting） Abstract available online: May 19th 5pm（EDT） Slides and posters available online: Jun 4thColorectalEnhertu 01 study（HER2 positive CRC, 3L, Ph2） Oral presentationBEGONIA study（TNBC 1L、Ph1b/2, durvalumab combo） Poster presentationDESTINY-Gastric01 study（HER2 positive GC, 3L, Ph2） Poster presentationTROPION-PanTumor01 study（NSCLC, Ph1） Poster presentationNSCLC Ph1 study, EGFR mutant cohort Oral presentationCRC: colorectal cancer, GC: gastric cancer, NSCLC：non-small cell lung cancer, TNBC: triple negative breast cancer37
ASCO 2021: IR Conference CallSunao ManabePresident and CEOKen TakeshitaGlobal R&D HeadFor investorslocated in JPMonday, June 7 - 6:30-8:00pm EDTFor investorslocated in ex-JPTuesday, June 8 - 7:00-8:30am EDTContent will be delivered on-demand after the meeting.38
Major Progress in FY2020ASCO 2021News Flow39
News FlowDESTINY-CRC01：HER2 positive CRC, 3L, Ph2 Data update planned at ASCO in June 2021 Data update planned at ASCO in June 2021 Data update planned at ASCO in June 2021 Planned to start in FY2021 Q1BEGONIA：TNBC, 1L, Ph1b/2, durvalumab comboDESTINY-Gastric01：HER2 positive GC, 3L, Ph2As or April 2021DS-1647/G47ΔDESTINY-Gastric04： HER2 positive GC, 2L , Ph3DS-3201Quizartinib Planned to start in FY2021 Q1 TLR anticipated in FY2021 Q2Tarlige TLR anticipated in FY2021 Q2Lixiana TLR anticipated in FY2021 Q4 TLR anticipated in FY2022 Q2DESTINY-Lung01： HER2 positive/mutated NSCLC, 2L, Ph2DESTINY-Breast03： HER2 positive BC, 2L, Ph3DESTINY-Breast04： HER2 low BC, post chemo, Ph3DESTINY-Breast02： HER2 positive BC, 3L, Ph3 JP: Approval anticipated in FY2021 Q1PTCL, Ph2 pivotalDESTINY-Breast09： HER2 positive BC, 1L, Ph3Enhertu Malignant gliomaEfient Planned to start in FY2021 Q1 TLR anticipated in FY2021 Q2JP: NDA planned in FY2021 Q4ATL/Lymphoma, Ph2 pivotalQuANTUM-First: AML, 1L, Ph3 TLR anticipated in FY2021 Q3Central neuropathic pain JP: NDA planned in FY2021 Q1Atrial fibrillation in the very elderly JP: Approval planned in FY2021 Q2Ischemic stroke JP: Approval planned in FY2021 Q3TROPION-PanTumor01：Ph1 TNBC cohortDato-DXd Data update planned at ESMO Breast in May 2021 Data update planned at ASCO in June 2021TROPION-PanTumor01：Ph1 NSCLC cohortNSCLC Ph1 EGFR mutated cohortHER3-DXd Data update planned at ASCO in June 2021 Planned to start in FY2021 Q1EGFR mt NSCLC, Ph1, osimertinib comboUnderlined: New or updated from FY2020 Q3AML: acute myeloid leukemia, ATL: adult T-cell leukemia, BC: breast cancer, CRC: colorectal cancer, GC: gastric cancer, NSCLC: non-small cell lung cancer, PTCL: peripheral T-cell lymphoma,TNBC: triple negative breast cancer, UC: urothelial cancer,40
1FY2020 Financial Results2FY2021 Forecast3Business Update4R&D Update5Update of Actions against COVID-196Appendix41
Update of Actions against COVID-19 nt ofCOVID-19Vaccines andTherapeutics Participating in fundamental research supported by AMED*1 and pursuing the development of genetic (mRNA) vaccine usingDaiichi Sankyo’s original novel nucleic acid delivery technology*2 Selected to be a provider for the MHLW’s “Emergent Initiative to Build Production Capacity for COVID-19 Vaccines*3 (FirstRound)” – Aug. 7, 2020 Subsidy 6.0 Bn JPY (Utilized to develop production and storage facilities for COVID-19 vaccine) Develop production capacity at Daiichi Sankyo Biotech Aim to build production platform technology in Japan that can accommodate not only COVID-19 , but also emerging andre-emerging infectious disease vaccines in the future Selected to be a company for the AMED’s drug discovery support program “Development of a Vaccine for COVID-19 Vaccines*4(Second Round)” – Aug. 31, 2020 Phase 1/2 study started in March 2021 Nafamostat*5 inhalation formulation （DS-2319）Manufacturing,Supply of COVID-19Vaccines Collaborative R&D with the University of Tokyo, RIKEN, Nichi-Iko Pharmaceutical Co., Ltd for the treatment of COVID-19 Daiichi Sankyo is responsible for formulation research, non-clinical studies and clinical development using technology gainedthrough the development of Inavir Conducted formulation research & non-clinical studies and started Phase 1 study in March 2021 COVID-19 vaccine by AstraZeneca（AZD1222） Daiichi Sankyo Biotech receives undiluted solution from AstraZeneca and initiated contract manufacturing (vial filling,packaging) in March 2021*1 "Fundamental Research on the Control of a Novel Coronavirus (2019-nCoV), which is an initiative supported by the Japan Agency for Medical Research and Development (AMED). (Principal investigator: Prof. YoshiroKawaoka, Institute of Medical Sciences, The University of Tokyo)*2 Technology focusing on forming lipid nanoparticle structures, stabilizing pharmaceutical active ingredients and delivering nucleic acids into immune cells. Compared to conventional vaccine technology, it has beendemonstrated to induce a more optimal immune response*3 The project aims to swiftly develop an actual (large-scale) production system for biologics, including vaccines, in order to ensure that the vaccines necessary for the prevention of the spread and severity of unexpectedepidemics, including COVID-19, are produced as soon as possible, and that their supply is secured for the Japanese people.42*4 The project aims to support the development of a vaccine against COVID-19, for which R&D is already underway, and aims to ensure the early commercialization of safe and effective vaccines.*5 A treatment for acute pancreatitis and disseminated intravascular coagulation (injectable)
1FY2020 Financial Results2FY2021 Forecast3Business Update4R&D Update5Update of Actions against COVID-196Appendix43
Major R&D Milestones in FY2021 (3ADCs)ProjectTarget Indications [phase, study name]HER2 , 3L [P2 pivotal, DESTINY-Breast01]FY2020Q4As of April 2021Q1GCHER2 low, post chemo [P3, DESTINY-Breast04]NSCLCCRCOthersDato-DXdStudy startedHER2 low, 3L combo [P1, DESTINY-Breast08]Study startedStudy startplannedUS approved (2L)Study startplannedHER2 , 2L [P3, DESTINY-Gastric04]HER2 /mutant [P2, DESTINY-Lung01]TLR anticipatedHER2 mutated [P2, DESTINY-Lung02]Study startedHER2 , 3L [P2, DESTINY-CRC02]Study startedHER2 mutated [P2, DESTINY-PanTumor01]Study startedNSCLC, w/o actionable mutation, pembrolizumab combo [P3, TROPION-Lung01]Study startedNSCLC, w/o actionable mutation, durvalumab combo [P1, TROPION-Lung04]Study startedNSCLC, with actionable mutation [P2, TROPION-Lung05]Study startedStudy startplannedTNBC, durvalumab combo [P1b/2, BEGONIA]HER3-DXdEGFR mutated NSCLC [P2 pivotal, HERTHENA-Lung01]EGFR mutated NSCLC, osimertinib combo [P1]Q4TLR anticipatedHER2 , 2L /1L combo [P1/2, DESTINY-Breast07]HER2 , 3L [P2 pivotal, DESTINY-Gastric01]Q3TLR anticipatedHER2 , 1L [P3, DESTINY-Breast09]EnhertuFY2021EU approvedHER2 , 2L [P3, DESTINY-Breast03]BCQ2Study startedStudy startplannedRed underlined: new or updated from FY2020 Q3BC: breast cancer, CRC: colorectal cancer, GC: gastric cancer, NSCLC: non-small cell lung cancer, TLR: Top Line Results, TNBC: triple negative breast cancer, UC: urothelial cancer,44
Major R&D Milestones in FY2021 (Alpha)As of April 2021ProjectTarget Indications [phase, study name, region]QuizartinibAML, 1L [P3, JP/US/EU/Asia]PexidartinibTenosynovial giant cell tumor [P2, L, ALL [P1/2, US]LixianaAF in the very elderly [P3, ELDERCARE-AF, JP]EfientIschemic stroke [P3,
FY2020: Vaccine business loss compensation Profit before tax FY2020: Financial income due to decrease in contingent consideration of Ambit/quizartinib acquisition Profit attributable to owners of the Company FY2020: Decrease in income taxes due to an increase in DTA attributable to future exp
ST. LOUIS PUBLIC SCHOOLS FY2020-2021 PROPOSED DISTRICT BUDGET REVENUES AND EXPENDITURES FUND SOURCES BUDGET CATEGORIES ACTUALS 2018-2019 PROJECTED . FY2020-2021 Proposed District Budget Page 1 of 22. 5111 Taxes, Current Ad Valorem 5112 Taxes, Delinquent Ad Valorem 5113 School District Trust Fund (Proposition C) 5114 Financial Institution .
Financial results briefing: Yes (Amounts are rounded down to the nearest million yen.) 1. Consolidated financial results for FY2020 (January 1, 20 20 – December 31, 2020) (1) Consolidated income information (The percentages represent the rates of increase (decreas
Sample RFQ Economic Development Funding Programs Fiscal Year 2020 1 . FY2020 Economic Development Funding RFQ . Instructions. The FY2020 Economic Development Funding Request for Qualifications (RFQ) must be completed in one session. and submitted (There
question F7. FY2020 Contractors Manual – Summary of Changes 00-3 FINANCIAL MANAGEMENT AND CAPACITY . FY2017 FY2018 FY2019 FY2020 1. FINANCIAL MANAGEMENT AND CAPACITY . financial report elements and source documentation added an indic
Investors Meeting Presentation for FY2020 (Year ended March 31, 2021) and Revision of Mid-term Business Plan 2022 May 13, 2021 Hiroshi Nomura, President and CEO Sumitomo Dainippon Pharma Co., Ltd. Disclaimer Regarding Forward-looking Statements 1
Financial Results Presentation Hiroyuki Okuzawa July 30, 2021 Director, Executive Officer, CFO . Business American Regent Business Oncology Business Japan Business FY2020 Results . consideration of Ambit
MTMSA 2968 Chronic Disease 2969 PHEP 2971 WIC 2973 MCH 2976 CD/IZ 2979 LAUNCH FY2019 Budget 118,608 - 210,226 193,090 43,134 7,000 FY2020 Request 73,504 - 111,567 143,008 - 50,000 100,000 150,000 200,000 250,000. 7 REVENUES We have estimated 4.90 million in re
American Revolution were the same white guys who controlled it after the American Revolution. And this leads us to the second, and more important way that as a revolution, the American one falls a bit short. So, if you've ever studied American history, you're probably familiar with the greatest line in the Declaration of Independence: “We hold these truths to be self-evident, that all men .
