第一三共（4568） – Top Management Presentation

FY2021 Q3 Financial Results PresentationDAIICHI SANKYO CO., LTD.Hiroyuki OkuzawaDirector, Executive Officer, CFOJanuary 31, 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 Q3 Financial Results2Business Update3R&D Update4Appendix3Overview of FY2021 Q3 Results(Bn JPY)*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 data4FY2020 Q3 YTDFY2021 Q3 YTDResultsResults+9.8%Cost of sales256.4263.26.8SG&A expenses229.3255.726.4R&D expenses163.7169.15.3+37.6%Temporary income 0.12.12.0Temporary expenses0.01.31.3+38.3%Profit before tax99.6125.926.3+24.4%CurrencyUSD/JPY106.11111.10RateEUR/JPY122.37130.62Profit attributable to ownersof the Company75.894.318.5+4.99+8.25Core operating profit89.4123.033.6Operating profit89.5123.834.3YoYRevenue738.8811.072.2******RevenueJapan BusinessJapan Business(incl. Innovative Pharmaceuticals,Generic, Vaccines, OTC)Oncology Business*1Oncology BusinessAmerican 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*3Increased by 72.2 Bn JPY (Increased by 51.6 Bn JPY excl. forex impact)Positive FactorsNegative Factors(Bn JPY)FY2020 ResultsFY2020 Results738.80.03.7Japan Business UnitLixianaTarligeEnhertuEmgalityDaiichi Sankyo EsphaEzetimibe AG+10.7+7.5+4.3+3.4+8.911.60.019.40.0NexiumMemary-21.2-11.08.80.0Oncology Business*1 Unit Enhertu+16.9Olmesartan-3.01.90.06.20.0American Regent UnitInjectaferGE injectables+8.2+8.520.60.0EU Specialty Business UnitLixiana+13.6FY2021 ResultsFY2021 Results811.0630.0 650.0 670.0 690.0 710.0 730.0 750.0 770.0 790.0 810.0Negative FactorsPositive Factors*1 Revenue for Daiichi Sankyo, Inc. and Daiichi Sankyo Europe’s oncology products *2 Dato-DXd: Datopotamab deruxtecan (DS-1062)*3 Forex impact USD: +7.5, EUR : +6.5, ASCA: +6.5Enhertu, Dato-DXd*2 Upfront Payment & Regulatory Milestone etc.Enhertu quid related paymentDato-DXd upfront payment+3.1+2.15Gain on sales of transferring long-listed productsOlmesartan-3.1-2.2Core Operating ProfitIncreased by 33.6 Bn JPY (Increased by 28.3 Bn JPY excl. forex impact) FY2020 ResultsFY2020 Results89.4RevenueRevenue0.072.2Cost of SalesCost of SalesSG&A ExpensesSG&A ExpensesR&D ExpensesR&D ExpensesForex ImpactForex ImpactRevenue+72.2incl. forex impact of +20.6(Bn JPY)0.04.6Cost of Sales+4.6 (Profit decreased)Improvement in cost of sales ratio by change in product mix18.50.0SG&A Expenses+18.5 (Profit decreased)0.00.2Increase in expenses related to Enhertu due to an increase in profit share of gross profit with AstraZeneca15.20.0Forex Impact+15.2 (Profit decreased)FY2021 ResultsFY2021 Results123.01.021.041.0Positive Factors61.081.0101.0141.0121.0Negative Factors161.0Cost of SalesSG&A ExpensesR&D Expenses+2.2+7.9+5.16Profit Attributable to Owners of the CompanyIncreased by 18.5 Bn JPYFY2020 ResultsFY2020 Results75.8CoreCore Operating OperatingProfitProfitTemporaryTemporary Income/ RevenueExpenses/ ExpensesFinancialFinancial Income/ Expenses etc./ ExpensesIncomeIncome Taxes etc.Income Taxes etc.33.60.00.00.70.08.00.07.7FY2021 ResultsFY2021 Results94.30.020.040.0Positive Factors60.0100.0Negative Factors80.0Temporary Income/Expenses-0.7 (Profit increased)FY2021: Gains related to sale of fixed assets(Osaka logistics center and others)Impairment loss(Intangible asset related to Turalio and others)Financial Income/Expenses etc.+8.0 (Profit decreased）FY2020: Financial income due to decrease in contingent consideration of Ambit/quizartinib acquisitionDeterioration in forex gains/losses(Bn JPY)-2.1+1.3+4.7+1.5Income Taxes etc.+7.7 (Profit decreased）Profit before TaxIncome Taxes etc.Tax rateFY2020 Q3YTDFY2021 Q3YTD（参考：税率）99.6125.923.924.0%31.625.1%YoY+26.3+7.7+1.1%7Revenue: Business Units (incl. Forex Impact)(Bn JPY)8FY2020 Q3 YTDFY2021 Q3 YTDResultsResults386.4393.7+7.351.549.7-1.835.449.2+13.818.036.6+18.51.32.0+0.791.0115.6+24.632.242.3+10.122.225.2+3.131.341.7+10.482.997.9+15.056.074.3+18.3　Nilemdo/Nustendi0.12.2+2.116.214.9-1.374.582.9+8.4CurrencyUSD/JPY106.11111.10+4.99RateEUR/JPY122.37130.62+8.25 EU Speciality Business　Lixiana　Olmesartan ASCA (Asia, South and Central America)　GE injectablesYoY Japan Business Daiichi Sankyo Healthcare Oncolgy Business　Enhertu　Turalio American Regent　Injectafer　VenoferRevenue: Major Products in Japan(Bn JPY)9FY2020 Q3 YTDFY2021 Q3 YTDResultsResultsLixianaanticoagulant59.870.5+10.7Nexiumulcer treatment60.839.6-21.2Praliatreatment for osteoporosis/ inhibitor of the progression ofbone erosion associated with rheumatoid arthritis26.428.7+2.3Tarligepain treatment15.322.8+7.5Teneliatype 2 diabetes mellitus treatment19.218.6-0.6Ranmarktreatment for bone complications caused by bone metastasesfrom tumors14.915.6+0.7Loxoninanti-inflammatory analgesic19.117.6-1.5Vimpatanti-epileptic agent11.213.9+2.7Canaliatype 2 diabetes mellitus treatment11.913.0+1.1Efientantiplatelet agent11.012.7+1.7Enhertuanti-cancer agent(HER2-directed antibody drug conjugate)2.76.9+4.3Rezaltasantihypertensive agent10.49.6-0.8Inaviranti-influenza agent2.31.1-1.2YoYAgenda1FY2021 Q3 Financial Results2Business Update3R&D Update4Appendix10ENHERTU®: Revenue* Revenue recognized in each period 11(Bn JPY)YoY(as of Jan.)vs. as of Oct.Product Sales43.522.861.2-1.6-Japan6.94.310.0-3.4-US31.613.643.90.9-Europe4.94.97.10.9-ASCA–0.2–Upfront payment7.4-9.8-149.0Regulatory milestone payment1.71.02.2-33.7US HER2+ Breast Cancer 3L0.7-0.9-13.7EU HER2+ Breast Cancer 3L0.40.40.5-7.9US HER2+ Gastric Cancer 2L + 3L0.60.60.8-12.13.13.13.43.417.255.726.976.61.8200.0FY2021 Q3 YTD ResultsFY2021 ForecastTotalConsiderationQuid related paymentTotal*****2**ENHERTU®: Performance in Each Region◆ Steady increase in product sales due to market penetration in launched countries◆ Product sales: FY2021 Q3 YTD results 43.5 Bn JPY (YoY +22.8 Bn JPY)FY2021 forecast 61.2 Bn JPY (YoY +31.1 Bn JPY)US (HER2+ Breast Cancer 3L, HER2+ Gastric Cancer 2L)Europe (HER2+ Breast Cancer 3L)◆ Product sales: FY2021 Q3 YTD results 31.6 Bn JPY (285Mn USD）FY2021 forecast 43.9 Bn JPY（400Mn USD）◆ Steady growth in the market➢ New patient shares increasing• HER2+ BC 3L: Maintaining No.1 share• HER2+ GC 2L: Good progress◆ Product sales: FY2021 Q3 YTD results 4.9 Bn JPY (44Mn USD)FY2021 forecast 7.1 Bn JPY（65Mn USD）◆ Steady growth in the launched countries ➢ New patient shares increasing (Maintaining No.1 share in France and UK)◆ Oct. 2021:ESMO Clinical Practice Guideline supported ENHERTU® as the new standard of care for HER2+ BC 2L*2 treatment◆ Nov. 2021: HER2+ GC 2L approval application accepted◆ Dec. 2021: HER2+ BC 2L approval application accepted◆ Nov. 2021: Classified as a category 1 preferred regimen for Japan (HER2+ Breast Cancer 3L, HER2+ Gastric Cancer 3L)HER2+ BC 2L treatment in NCCN*1 guidelines based on DESTINY-Breast03 data◆ Jan. 2022: HER2+ BC 2L approval application accepted◆ Product sales: FY2021 Q3 YTD results 6.9 Bn JPYFY2021 forecast 10.0 Bn JPY◆ Steady growth in the market ➢ New patient shares increasing (Maintaining No.1 share in HER2+ BC 3L / GC 3L)◆ Dec. 2021: HER2+ BC 2L approval application accepted*1 NCCN: National Comprehensive Cancer Network *2 HER2 positive metastatic breast cancer with no, unknown, or stable brain metastasis12Japan Business: Enhance product portfolioEfient®（prasugrel hydrochloride）Reyvow®（lasmiditan succinate）Obtained approval for additional indication of antiplatelet agent “Efient” which has been on the market since 2014 * Indications: The following ischemic heart diseases that require percutaneous coronary intervention (PCI): Acute coronary syndromes (ACS; unstable angina [UA], non-ST-segment elevation myocardial infarction [NSTEMI], or ST-segment elevation myocardial infarction [STEMI]), Stable angina, old myocardial infarctionEli Lilly Japan obtained marketing approval for “Reyvow”, a migraine treatment which the company and Daiichi Sankyo signed an agreement on reverse co-promotion* in August 2021* Eli Lilly Japan is responsible for clinical development and manufacturing.Daiichi Sankyo is in charge of distribution and sales, and the companies will co-promote the product. ◆ Additional Indications: Prevention of recurrence of ◆ Indication: Migraineischemic 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)◆ Date of Approval: December 24, 2021 ◆ Dosage and Administration: 3.75 mg once daily oral dose◆ Date of Approval: January 20, 2022◆ Dosage and Administration: 100 mg taken orally once, for the migraine attack (50 mg or 200 mg can be taken orally once)◆ Expanding contribution to patients by providing new treatment options◆ Enhancing product portfolio toward sustainable growth of Japan business13US: Divested ProductsConcluded an asset sale agreement in January 2022 to promote transformation into a profit structure focused on patented drugs➢ Divested ProductsBrand NameGeneric NameTherapeutic CategoryLaunchedRevenueFY2021 Forecastolmesartan medoxomiland its fixed dose combinationsAntihypertensive agentcolesevelam HCL tablets and oral suspensionHypercholesterolemia treatment/ type 2 diabetes mellitus treatment9.9 Bn JPYprasugrel hydrochlorideAntiplatelet agentcevimeline hydrochloride hydrateDry mouth in people with Sjogren’s Syndrome2002～2010200020092000➢ New OwnerCosette Pharmaceuticals, Inc.➢ ScheduleCommercialization start by CosetteBy July 1, 2022Until June 2024 Manufacture and supply to Cosette(up to 30 months after signing the contract)14Reorganization of R&D StructureDecided to winddown business of R&D subsidiary, Plexxikon Inc.Overview of Plexxikon Inc. Outline of Reorganization◆ Major R&D area ➢ Oncology and neurology◆ Launched Products from Plexxikon pipeline➢ Tenosynovial Giant Cell Tumor (TGCT) treatmentTuralio® (pexidartinib)• Launched in US, under development in JP and ASCA region➢ Melanoma treatment*Zelboraf® (vemurafenib)• Marketed by Roche group◆ Major R&D project➢ BET inhibitor PLX2853*BRAF V600 mutation-positive advanced or inoperable melanoma treatment◆ Some R&D projects to be transferred to Daiichi Sankyo◆ Employment will be terminated(Number of employees as of January 2022: approx. 60 employees）◆ Majority of business will end by March 2022◆ Reorganization expenses expected to be recognized in FY2021 Q4Enhance R&D capabilities for sustainable growth by optimizing resource allocation15Agenda1FY2021 Q3 Financial Results2Business Update3R&D Update4Appendix163ADC UpdateAlpha UpdateNews Flow17ENHERTU®: DESTINY-Breast03 efficacy dataProgression-Free Survival (blinded independent central review)BICR, 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. Ann Oncol. 2021; 32(suppl_5):S1283-S1346. 10.1016/annonc/annonc741ENHERTU® demonstrated unparalleled improvement in PFS compared to T-DM1in patients with HER2 positive metastatic breast cancer18ENHERTU®: SABCS 2021 highlightsDESTINY-Breast03 sub-analysis data of patients with stable brain metastases Progression-Free SurvivalIntracranial Response（BICR、RECIST 1.1）HR: hazard ratio, mPFS, median progression-free survivalBICR: blinded independent central review, CR: complete response, PD: progressive disease, PR: partial response, SD: stable disease aDenominator for percentages is the number of subjects in the full analysis set with brain metastases tumor assessment◆ As for patients with HER2 positive breast cancer with stable brain metastases, ENHERTU® showed greater efficacy compared to T-DM1◆ As for anti-tumor responses in brain metastases lesion、ENHERTU® showed greater intracranial response compared to T-DM119ENHERTU®: Other updates◆ Metastatic 2nd lineBased on DESTINY-Breast03 (Ph3) data:➢ Dec 2021: Filing accepted in Japan & Europe➢ Jan 2022: Filing accepted in US and granted Priority Review (PDUFA date: May 17) ➢ Simultaneous filings are ongoing in multiple countries under Project OrbisHER2 positive breast cancerHER2 positive gastric cancer◆ Metastatic 2nd line➢ Nov 2021: Filing accepted in Europe based on the data of DESTINY-Gastric01 (3L, Ph2, JP/KR)、DESTINY-Gastric02 (2L, Ph2, US/EU)studies◆ Neoadjuvant◆ Metastatic 1st line➢ Nov 2021: Initiated DESTINY-Breast11 (Ph3) study for patients with early breast cancer study➢ Dec 2021: Initiated DESTINY-Lung04 (Ph3) HER2 mutated NSCLCRegulatory filings and new clinical studies in multiple tumor types20Dato-DXd: Breast cancer updateSABCS 2021: TROPION-PanTumor01 triple negative breast cancer (TNBC) cohort dataAnti-tumor responses（Blinded Independent Central Review ）All patients with TNBCPatients with TNBC without prior Topo I inhibitor-based ADCBICR, blinded independent central review; SoD, sum of diameters.In Ph1 with heavily pretreated patients with TNBC, Dato-DXd showed encouraging efficacy with ORR at 34% in all patients (n=44) and 52% in patients without prior Topo I inhibitor-based ADC (n=27)As a potentially best in class TROP2 directed ADC, development in breast cancer is ongoing:◆ Planning Ph3 study for patients with TNBC ◆ Nov 2021: Initiated TROPION-Breast01 (2/3L, Ph3) study for patients with HR+/HER2- breast cancer21HER3-DXd: Lung cancer updateASCO 2021: Ph1 efficacy dataDec 2021: FDA granted breakthrough therapy designation ◆ For the treatment of patients with metastatic EGFR mutated NSCLC with disease progression on or after treatment with a 3rdgeneration EGFR TKI and platinum based therapies◆ Based on Ph1 data presented at ASCO 2021◆ First breakthrough therapy designation for HER3-DXdNSCLC: non small cell lung cancer, TKI: tyrosine kinase inhibitorBICR, 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*.Demonstrated tumor response across multiple EGFR TKI resistance mechanisms Initiated HERTHENA-Lung01 (registrational Ph2) study in Feb 2021, registration plan to be determined by close communication with FDA223ADC UpdateAlpha UpdateNews Flow23DS-5670: Change in development planTop priority is development of booster vaccination ◆ Taking into consideration the current situation, development of booster vaccination in Japan will be the top priority and commercialization is expected within CY2022➢ Initiated Ph1/2/3 study in Jan 2022◆ Ph3 study plan for naïve subjects will be continuously discussed with PMDA towards initiation of the study in FY2022 H1.➢ Initiated Ph2 for dose setting in Nov 2021 ➢ Ph3 study was planned to start in overseas (Africa, etc.) in FY2021 , however, the study was postponed due to global spread of omicron variant➢ Planning to discuss Ph3 study design, countries, study timing, etc. with PMDAFY2021FY20221H2H1H2HPh1/2/3 booster vaccination (JP)Ph1/2 studyDose setting Ph2Ph3 study plan under considerationEstablishment of manufacturing system at DS Biotech24DS-5670: Study design of booster vaccination◆ Study: Randomized, active-controlled, evaluator-blinded Ph1/2/3 study to evaluate the booster effect in subjects who completed the initial vaccination (1st & 2nd shots) of approved SARS-CoV-2 vaccine(dose confirmation, non-inferiority confirmatory study)◆ Eligible subjects: Adult and elderly subjects who completed the initial vaccination (1st & 2nd shots) of approved SARS-CoV-2 vaccine and have elapsed 6 months after the second shot◆ Primary endpoint: Geometric mean fold rise (GMFR) of SARS-CoV-2 neutralizing activity in blood 4 weeks after administrationPart 1Dose confirmation study528 subjectsDose escalationpart ＋Dose comparisonpartPart 2Active-controlled, non-inferiority study4500 subjectsComirnaty®initial vaccinated (1st & 2nd shots)Spikevax®initial vaccinated(1st & 2nd shots)RandomizeRandomizeDS-5670Comirnaty®DS-5670Spikevax®25Valemetostat: Adult T cell leukemia/lymphoma (ATL/L) updateAmerican Society of Hematology 2021: ATL/L registrational Ph2 dataa One patient was not evaluated for skin lesions after baseline assessment. b Refractory: received ≥1 prior chemotherapy, achieved SD and required a treatment switch, or received ≥1 prior chemotherapy and experienced PD. ◆ Showed encouraging efficacy in registrational Ph2 study targeting relapsed/refractory ATL/L◆ Based on the study data, the following events occurred in Japan➢ Nov 2021: Granted orphan drug designation➢ Dec 2021: Regulatory filing 26Alpha: Other updatesquizartinibDS-7011◆ FLT3-ITD positive AML◆ Systemic lupus erythematosus➢ Mechanism of action: Anti-TLR7 antibody➢ Collaboration: CiCLE program (AMED)➢ Status: Ph1 study planned in FY2021 Q4➢ Nov 2021: Obtained TLR of QuANTUM-First (1L, Ph3) study, meeting the primary endpoint for overall survival➢ FY2022: Regulatory filing and data presentation at scientific conference planned AML: acute myeloid leukemia, TLR: Top Line ResultsDiagram created & provided by Prof. Miyake of the Institute of Medical Science, The University of Tokyo Obtained Ph3 data of quizartinib and Ph1 study of DS-7011 will start soon273ADC UpdateAlpha UpdateNews Flow28FY2021 News FlowAs of Jan 2022Planned publicationsASCO Genitourinary Cancers Symposium (Feb 17-19, 2022)ENHERTU®Ph1b nivolumab combinationUrothelial carcinoma cohort dataDS-7300Solid tumor Ph1/2CRPC subanalysis data••Key data readoutsENHERTU®•FY2021 Q4DESTINY-Breast04: HER2 low BC, post chemo, Ph3Planned pivotal study initiationDato-DXd•FY2021 Q4TROPION-Lung08: NSCLC w/o AGAs, 1L, Ph3Underlined: New or updated from FY2021 Q2CRPC: castric resistant prostate cancer, NSCLC: non small cell lung cancer29Agenda1FY2021 Q3 Financial Results2Business Update3R&D Update4Appendix30Major R&D Milestones in FY2021 (3ADCs)ProjectTarget Indications [phase, study name]HER2+, 2L [P3, DESTINY-Breast03]BCHER2 low, post chemo [P3, DESTINY-Breast04]HER2+, 1L [P3, DESTINY-Breast09]HER2+, neoadjuvant [P3, DESTINY-Breast11]ENHERTUⓇHER2+, 2L [P2, DESTINY-Gastric02]GCHER2+, 2L [P3, DESTINY-Gastric04]HER2+, 3L [P2, DESTINY-Gastric06]NSCLCHER2+, combination [P1b, DESTINY-Lung03]HER2 mutated, 1L [P3, DESTINY-Lung04]TNBC, durvalumab combo [P1b/2, BEGONIA]HR+ BC, 2/3L [P3, TROPION-Breast01]Dato-DXdAs of Jan 2022Q1FY2021Q2TLR obtainedQ3FiledQ4TLR anticipatedStudy startedTLR obtainedStudy startedStudy startedStudy startedStudy startedFiled (EU)Study startedStudy startedStudy started NSCLC w/o AGAs, 1L, pembrolizumab combo [P3, TROPION-Lung08]HER3-DXdEGFR mutated NSCLC, osimertinib combo [P1]Study startedStudy start plannedRed underlined: new or updated from FY2021 Q2AGA: actionable genomic alterations, BC: breast cancer, GC: gastric cancer, NSCLC: non-small cell lung cancer, TLR: Top Line Results, TNBC: triple negative breast cancer31Major R&D Milestones in FY2021 (Alpha)ProjectTarget Indications [phase, study name, region]Q1Q2Q3Q4As of Jan 2022FY2021TLR obtainedQuizartinibAML, 1L [P3, JP/US/EU/Asia]PexidartinibTenosynovial giant cell tumor [P2, JP]Teserpaturev/G47Δ Malignant glioma [IIS, JP]Valemetostat(DS-3201)ATL/lymphoma [P2 registration, JP]PTCL [P2 registration, JP/US/EU/Asia] AML, ALL [P1/2, US]DS-1594LixianaⓇEfientⓇTarligeⓇStudy startedApprovedStudy startedStudy startedTLR obtainedFiledAF in the very elderly [P3, ELDERCARE-AF, JP]ApprovedIschemic stroke [P3, PRASTRO III, JP]ApprovedCentral neuropathic pain [P3, JP]FiledDS-6016Fibrodysplasia ossificans progressiva [P1, JP]Study startedDS-7011Systemic lupus erythematosus [P1, US]Study start plannedVN-0200RS virus vaccine [P1, JP]Study startedDS-5670COVID-19 mRNA vaccine [P2, JP]COVID-19 mRNA vaccine, booster [P1/2/3, JP]Study startedStudy startedRed underlined: new or updated from FY2021 Q2 AF: atrial fibrillation, ALL: acute lymphoblastic leukemia, AML: acute myeloid leukemia, ATL: adult T-cell leukemia, IIS: investigator-initiated study, PTCL: peripheral T-cell lymphoma, TBD: to be determined, TLR: Top Line Results32Major R&D Pipeline: 3ADCsPhase 1(US/EU/Asia) HER2+ BC 2L~/1LDESTINY-Breast07(US/EU/Asia) HER2 low BC chemo naïve/ post chemoDESTINY-Breast08(US/EU/Asia) TNBC (durvalumab combo)BEGONIA(China) HER2+ GC 3L DESTINY-Gastric06Phase 2Phase 3Submitted(JP/US/EU/Asia)HER2+ BC 3LDESTINY-Breast02(JP/US/EU/Asia) HER2+ BC 2L DESTINY-Breast03 As of Jan 2022(JP/US/EU/Asia) HER2 low BCpost chemoDESTINY-Breast04(EU) HER2+ GC 2L DESTINY-Gastric02(US/EU/Asia) HER2+ GC combo, 2L~/1LDESTINY-Gastric03(JP/US/EU)HER2+/mutated NSCLC 2L~DESTINY-Lung01 (JP/US/EU/Asia) HER2+ BC post neoadjuvantDESTINY-Breast05(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(EU/Asia)HER2+ NSCLC (durvalumab combo) 1LDESTINY-Lung03(US/EU) BC, bladder (nivolumab combo)(US/EU) BC, NSCLC (pembrolizumab combo)(JP/US)EGFR mutated NSCLC (osimertinib combo)(JP/US) HER3+ BC(JP/US/EU/Asia) solid tumors (AZD5305 combo)PETRAENHERTUⓇDato-DXdHER3-DXd(JP/US/EU/Asia) HER2 mutated NSCLC 2L~DESTINY-Lung02(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 low BC chemo naiveDESTINY-Breast06(US)HER2+ BC 1LDESTINY-Breast09(JP/US/EU/Asia) HER2+ BC neoadjuvantDESTINY-Breast11(JP/EU/Asia) HER2+ GC 2LDESTINY-Gastric04(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) EGFR mutated NSCLC HERTHENA-Lung01(US/EU/Asia) NSCLC 1L(w/ exon 19 or exon 20 mutation) DESTINY-Lung04(JP/US/EU/Asia) NSCLC(w/o actionable mutation) TROPION-Lung01(JP/US/EU/Asia) HR+ BC 2/3LTROPION-Breast01BC: breast cancer, CRC: colorectal cancer, GC: gastric cancer, NSCLC: non-small cell lung cancer, SCLC: small cell lung cancer, TNBC: triple negative breast cancer□: project in oncology that is planned to be submitted for approval based on the results of phase 2 trials : Breakthrough Designation (US)33Major R&D Pipeline: AlphaAs of Jan 2022DS-7300 (JP/US)B7-H3-directed ADCESCC, CRPC, SCLC, etc.Phase 1PLX2853 (US)BET inhibitor AMLDS-6000 (US)CDH6-directed ADC Renal cell carcinoma, ovarian cancerPLX2853 (US)BET inhibitor Solid tumorPhase 2Valemetostat (DS-3201)(JP/US/EU/Asia)EZH1/2 inhibitorPTCLValemetostat (DS-3201) (EU)EZH1/2 inhibitorBCLPhase 3Quizartinib (JP/US/EU/Asia)FLT3 inhibitor1L AMLSubmittedTarlige (JP)α2δ LigandsCentral neuropathic painPexidartinib (JP/Asia)CSF-1/KIT/FLT3 inhibitorTenosynovial giant cell tumorValemetostat (DS-3201) (JP)EZH1/2 inhibitorATL/LDS-1055 (JP/US)Anti-GARP antibodySolid tumorsDS-1211 (US)TNAP inhibitorPseudoxanthoma elasticumPLX2853 (US)BET inhibitor Gynecologic neoplasms, ovarian cancerPLX2853 (US)BET inhibitor Prostate cancerDS-1001 (JP) Mutant IDH1 inhibitorGliomaDS-5141 (JP)ENA oligonucleotide DMDDS-6016 (JP)Anti-ALK2 antibodyFibrodysplasia ossificans progressivaDS-1594 (US)Menin-MLL binding inhibitorAML, ALLDS-5670 (JP)mRNA vaccineCOVID-19Minnebro (JP)MR blockerDiabetic nephropathyVN-0102/JVC-001 (JP)Measles mumps rubella combined vaccineDS-5670 (JP)mRNA vaccine (Booster)COVID-19VN-0107/MEDI3250 (JP)Live attenuated influenza vaccine nasal sprayDS-7011 (US)Anti-TLR7 antibodySystemic lupus erythematosus VN-0200 (JP)RS virus vaccineRS virusOncologySpecialty medicineVaccineAF: atrial fibrillation, ALL: 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, GIST: gastrointestinal stromal tumor, 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)34Contact address regarding this materialDaiichi Sankyo Co., Ltd.Corporate Communications DepartmentTEL: +81-3-6225-1125Email: DaiichiSankyoIR@daiichisankyo.co.jp35