#1Passion for Innovation. Compassion for Patients™M FY2021 Q1 Financial Results Presentation DAIICHI SANKYO CO., LTD. Hiroyuki Okuzawa Director, Executive Officer, CFO July 30, 2021 Daiichi-Sankyo#2Forward-Looking Statements Daiichi-Sankyo Management 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 agency worldwide 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. 2#3Agenda FY2021 Q1 Financial Results 2 Business Update 3 R&D Update 4 Appendix Daiichi-Sankyo 3#4Overview of FY2021 Q1 Results FY2020 Q1 Results FY2021 Q1 Results YOY (Bn JPY) Revenue 236.9 264.1 +11.4% 27.1 Cost of sales 82.2 85.2 2.9 SG&A expenses 71.8 81.2 9.4 R&D expenses 48.9 54.0 5.2 Core operating profit 34.1 43.7 +28.2% 9.6 Other revenue 0.1 2.1 2.0 Other expenses 0.0 0.0 -0.0 Operating profit 34.1 45.8 +34.1% 11.6 Profit before tax Profit attributable to owners of the Company 41.4 47.1 5.7 31.9 35.2 +10.6% 3.4 107.62 118.47 109.49 131.95 +1.87 +13.48 Daiichi-Sankyo Currency Rate USD/JPY EUR/JPY As an indicator of ordinary profitability, "core operating profit" which excludes temporary gains and losses (other revenue and other expenses) from operating income is disclosed. Gains and losses related to: sale of fixed assets, restructuring (excluding the sales of pipeline and launched products), impairment, loss compensation, reconciliation, and other non-temporary and material gains and losses are included in the "temporary gains and losses". Temporary gains and losses are excluded from results and forecast for cost of sales, SG&A expenses and R&D expenses shown in the list above. 4#5Revenue Increased by 27.1 Bn JPY (Increased by 20.5 Bn JPY excl. forex impact) Daiichi-Sankyo Positive Factors (Bn JPY) Negative Factors FY2020 Results Japan Business (incl. Innovative Pharmaceuticals, Generic, Vaccines, OTC) Oncology Business*1 236.9 Japan Business Unit Lixiana +3.1 Memary -10.7 0.8 Tarlige +2.8 Enhertu +2.0 2.7 Daiichi Sankyo Espha +2.5 Ezetimibe AG, Memantine AG etc. Vaccines business Rotarix -1.5 American Regent 11.9 Daiichi Sankyo Healthcare +1.1 Roxionin EU Specialty Business 1.7 Oncology Business*1 Unit ASCA 1.7 Enhertu +5.6 Olmesartan -2.2 (Asia, South and Central America) Enhertu, Dato-DXd*2 Upfront Payment & Regulatory Milestone Forex Impact*3 American Regent Unit 1.8 Injectafer +5.2 GE injectables +5.1 6.6 FY2021 Results 264.1 EU Specialty Business Unit Lixiana +4.6 Gain on sales of transferring long-listed products -3.2 Positive Factors Negative Factors *1 Revenue for Daiichi Sankyo, Inc. and Daiichi Sankyo Europe's oncology products *2 Dato-DXd: Datopotamab deruxtecan (DS-1062) Enhertu, Dato-DXd*² Upfront Payment & Regulatory Milestone Dato-DXd upfront payment +1.5 *3 Forex impact USD: +0.9, EUR: +3.5, ASCA: +2.2 5#6Core Operating Profit Increased by 9.6 Bn JPY (Increased by 6.6 Bn JPY excl. forex impact) FY2020 Results 34.1 Revenue Cost of Sales SG&A Expenses R&D Expenses Forex Impact FY2021 Results 43.7 27.1 Positive Factors 3.6 4.0 7.1 Negative Factors Revenue incl. forex impact of +6.6 Cost of Sales +27.1 +2.8 (Profit decreased) Daiichi-Sankyo (Bn JPY) Improvement in cost of sales ratio by change in product mix 2.8 SG&A Expenses +7.1 (Profit decreased) Increase in expenses related to Enhertu due to an increase in profit share of gross profit with AstraZeneca R&D Expenses +4.0 (Profit decreased) Increase in 3ADCS* R&D investments Forex Impact +3.6 (Profit decreased) Cost of Sales +0.1 SG&A Expenses +2.3 R&D Expenses +1.2 * 3ADCs: 1) Enhertu, Trastuzumab deruxtecan (T-DXd, DS-8201), 2) Datopotamab deruxtecan (Dato-DXd, DS-1062) and 3) Patritumab deruxtecan (HER3-DXd, U3-1402) 6#7Profit Attributable to Owners of the Company Increased by 3.4 Bn JPY Daiichi-Sankyo (Bn JPY) Other Revenue/Expenses -2.0 (Profit increased) FY2020 Results 31.9 FY2021: Gains related to sale of Osaka logistics center -2.1 Core Operating 9.6 Financial Income/Expenses etc. +6.0 (Profit Decreased) Profit Other Revenue/ Expenses Financial Income/ Expenses etc. 2.0 FY2020: Financial income due to decrease in contingent consideration of Ambit/quizartinib acquisition Deterioration in forex gains/losses +4.7 +0.6 6.0 Income Taxes etc. +2.3 (Profit Decreased) FY2020 Q1 FY2021 Q1 YOY Income Taxes etc. 2.3 Profit before Tax Income Taxes etc. 41.4 47.1 +5.7 9.6 11.8 +2.3 FY2021 Results 35.2 Tax rate 23.1% 25.2% +2.1% Positive Factors Negative Factors 7#8Revenue: 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) Currency Rate (Bn JPY) FY2020 Q1 FY2021 Q1 YOY Results Results 130.2 129.1 -1.1 14.3 15.4 +1.1 11.6 14.5 +2.9 5.0 10.8 +5.8 0.3 0.6 +0.3 26.5 39.1 +12.6 9.4 14.9 +5.4 6.9 7.9 +1.0 8.5 13.8 +5.3 27.7 32.7 +5.0 16.4 23.4 +7.0 - 0.7 +0.7 5.2 5.6 +0.4 22.5 26.5 +3.9 Daiichi-Sankyo USD/JPY 107.62 109.49 +1.87 EUR/JPY 118.47 131.95 +13.48 8#9Revenue: Major Products in Japan Daiichi-Sankyo (Bn JPY) FY2020 Q1 FY2021 Q1 YOY Results Results Lixiana anticoagulant 19.8 22.9 +3.1 Nexium ulcer treatment 19.9 19.7 -0.2 treatment for osteoporosis/ inhibitor of the progression of Pralia 8.7 9.2 +0.5 bone erosion associated with rheumatoid arthritis Tarlige pain treatment 4.3 7.1 +2.8 Tenelia type 2 diabetes mellitus treatment 6.6 6.4 -0.2 Ranmark treatment for bone complications caused by bone metastases from tumors 5.0 5.1 +0.2 Loxonin anti-inflammatory analgesic 6.2 5.8 -0.4 Vimpat anti-epileptic agent 3.8 4.5 +0.7 Canalia type 2 diabetes mellitus treatment 3.9 4.3 +0.4 Efient antiplatelet agent 3.8 4.1 +0.3 anti-cancer agent Enhertu 0.2 2.2 +2.0 (HER2-directed antibody drug conjugate) Rezaltas antihypertensive agent 3.6 3.3 -0.3 Inavir anti-influenza agent 0.6 0.3 -0.3 9#10FY2021 Q1 Financial Results 2 Business Update 3 R&D Update 4 Appendix Daiichi-Sankyo 10#11ENHERTU®: Revenue (Bn JPY) <Reference> FY2021 Q1 Results FY2021 Forecast YOY (as of Jul.) vs. as of Apr. Total Consideration Product Sales Japan US Europe ASCA 13.0 7.7 61.0 -8.4 2.2 2.0 13.4 9.6 4.6 42.4 -8.0 1.2 1.2 5.1 -0.4 0.2 Upfront payment * 1 2.5 * 1 9.8 149.0 * 1 *1 Regulatory milestone payment 0.6 0.3 2.2 -2.6 33.7 US HER2+ Breast Cancer 3L 0.2 0.9 13.7 EU HER2+ Breast Cancer 3L 0.1 0.1 0.5 7.9 US HER2+ Gastric Cancer 2L + 3L 0.2 0.2 0.8 12.1 *2 US HER2+ or HER2 Mutant NSCLC 2L -2.6 Total 16.0 8.1 73.1 -11.0 182.7 *1 Revenue recognized in each period Daiichi-Sankyo *2 Revenue based on the assumption that milestone will be achieved in FY2021; Expected consideration converted with forex rate of 105 JPY to 1 USD: 13.1 billion yen 11#12ENHERTU®: Performance in Each Region Steady increase in product sales due to market penetration in launched countries and expansion in market Product sales: FY2021 Q1 Results 13.0 Bn JPY (YOY +7.7 Bn JPY) 61.0 Bn JPY (YoY +30.9 Bn JPY) Daiichi-Sankyo >ENHERTU trastuzumab deruxtecan FY2021 Forecast US (HER2+ Breast Cancer 3L, HER2+ Gastric Cancer 2L) Europe (HER2+ Breast Cancer 3L) Steady growth in the market New patient share as planned ➤ Outlets purchasing as planned Accumulated total of outlets purchasing Steady expansion in the market ➤ EU: Launched in FY2020 Q4 ➤ UK: Launched in FY2021 Q1 Japan (HER2+ Breast Cancer 3L, HER2+ Gastric Cancer 3L) Steady growth in the market New patient share as planned Outlets purchasing as planned Accumulated total of outlets purchasing 2020 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2021 Jan Feb Mar Apr May Jun 2020 May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun 12#13Japan: New Product Approval Oncolytic virus G47A* (product name: DELYTACT ® ) was approved in June 2021, which was co-developed with Dr. Todo of the Institute of Medical Science, The University of Tokyo The first oncolytic virus in the world to target malignant glioma Generic name: teserpaturev Indication: malignant glioma Grade III and grade IV among glioma which originates in glial cells in brain tissue ➤ Estimated number of new patients in Japan: around 2,800 patients annually Overview of the approval Daiichi-Sankyo The approval is primarily based on the results of Japan Ph2 study (investigator initiated study) in patients. with residual or recurrent glioblastoma conducted by Dr. Todo of the Institute of Medical Science, The University of Tokyo ➤ Received conditional and time-limited approval which requires verification of clinical benefit and safety within 7 years for all patients treated with DELYTACT ® *G47A The third generation oncolytic herpes simplex virus type 1 created by Dr. Todo and his colleagues at the Institute of Medical Science, The University of Tokyo. DELYTACT® has triple mutation within the viral genome and is designed to replicate selectively in cancer cells. 13#141 FY2021 Q1 Financial Results 2 Business Update 3 R&D Update 4 Appendix Daiichi-Sankyo 14#153ADCs update Alpha update WCLC/ESMO 2021 News Flow Daiichi-Sankyo 15#16ENHERTU®: Breast cancer DESTINY-Breast03 study (HER2+, 2L, Ph3): TLR of interim analysis anticipated in FY2021 Q2 as originally planned DESTINY-Breast09 study (HER2+, 1L, Ph3): First patient dosed in June Daiichi-Sankyo Presented interim results of BEGONIA study and subgroup analysis data of DESTINY-Breast01 study in patients with brain metastasis at ASCO 2021 BEGONIA interim results (durvalumab combo) 20 DESTINY-Breast01 brain met subgroup analysis 100 80 n=15 Progressive Disease Partial Response -20 Change in target lesion from baseline (%) -60 Best response ▲ Partial response (confirmed) PD-L1 expression 5% cutoff Unknown Negative Positive 60 60 40 40 20 20 0 -20 -40 -60 -80 Stable Disease -100 0 6 12 18 24 30 Weeks 36 42 48 54 HO PD SD PR 60 60 * If the best percentage change from baseline of target lesions cannot be calculated due to progression, withdrawal or death, the value is imputed at +20% Number of subjects that had the opportunity to complete at least two on-treatment disease assessments or have PD or death 3 patients with reported baseline measurements had no change over time. 2 patients with brain metastases at baseline did not have sufficient data to evaluate response in the brain and are not shown. ● Stable disease (≥5 wks) Progressive disease -80- Not yet evaluables Durable responses were observed in patients with stable, treated brain metastases. The confirmed ORR was 66.7% in Arm 6 (HER2 low/ER-/PR- BC, ENHERTU® + durvalumab) of BEGONIA study. BC: breast cancer, ER: estrogen receptor, ORR: objective response rate, PR: progesterone receptor, TLR: top line results 16#17ENHERTU®: Gastric cancer DESTINY-Gastric02 study (HER2+, 2L, Ph2, US/Europe): TLR obtained in June Filing strategy currently under discussion with European health authority in FY2021 2H. DESTINY-Gastric04 study (HER2+, 2L, Ph3, global): First patient dosed in June Ph3 study with overall survival as primary endpoint in patients with 2nd line metastatic gastric cancer ➤ The study data is required for filing in Japan DESTINY-Gastric02 study design 2L HER2 positive metastatic gastric cancer Endpoints: ORR ENHERTUⓇ as well as other endpoints DESTINY-Gastric04 study design 2L HER2 positive metastatic gastric cancer Endpoints: OS as well as other endpoints ORR: objective response rate, OS: overall survival, TLR: top line results ENHERTUⓇ Randomize 1:1 Ramucirumab + Paclitaxel Daiichi-Sankyo 17#18ENHERTU®: NSCLC, CRC DESTINY-Lung01 study (HER2 mutated/overexpressing, 2L+, Ph2): TLR obtained in June Daiichi-Sankyo HER2 mutated: Granted breakthrough therapy designation in US, filing strategy to be discussed with health authorities HER2 overexpressing: Development strategy under discussion based on the data Presented DESTINY-CRC01 study (HER2 expressing, 3L+, Ph2) final results at ASCO 2021 40 DESTINY-CRC01 efficacy DESTINY-CRC01 safety Adverse Events in ≥20% of Patients HER2 IHC3+ or IHC2+/ISH+ Cohort A (n = 53) HER2 IHC2+/ISH- Cohort B (n=15) Any Grade HER2 IHC1+ Cohort C (n = 18) Best % Change From Baseline in the Sum of Diameters of Measurable Tumors -20 -40 -60 HER2 IHC3+ or IHC2+/ISH+ Cohort A (n = 49a) -80 A IHC3+ IHC2+/ISH+ Prior anti-HER2 treatment -100 Overall (N = 86) n (%) Any Grade Any Grade Patients with any TEAE 53 (100) 15 (100) 18 (100) Any Grade 86 (100) Grade ≥3 56 (65.1) Nausea 37 (69.8) 9 (60.0) 7 (38.9) 53 (61.6) 5 (5.8) Anemia 21 (39.6) 4 (26.7) 6 (33.3) 31 (36.0) 12 (14.0) Fatigue 21 (39.6) 7 (46.7) 3 (16.7) 31 (36.0) 1 (1.2) Decreased appetite 18 (34.0) 5 (33.3) 7 (38.9) 30 (34.9) 0 Platelet count decreased 17 (32.1) 4 (26.7) 7 (38.9) 28 (32.6) 8 (9.3) Vomiting 23 (43.4) 3 (20.0) 1 (5.6) 27 (31.4) 1 (1.2) Neutrophil count decreased Diarrhea 20 (37.7) 2 (13.3) 4 (22.2) 26 (30.2) 19 (22.1) 19 (35.8) 0 4 (22.2) 23 (26.7) 1 (1.2) Interstitial Lung Disease (ILD) * HER2 IHC2+/ISH+ with an NRAS mutation b A All Patients (N=86) Grade 1 n (%) 0 a4 patients from the full analysis set were excluded since 1 patient had no measurable target lesion and 3 patients had no postbaseline data. By local assessment. Grade 2 4 (4.7) Grade 3 1 (1.2) Grade 4 0 Grade 5 Any Grade/Total 3 (3.5)a 8 (9.3)b.c Promising efficacy profile, ORR 45.3%, mDOR 7 months, mPFS 6.9 months, mOS 15.5 months, were observed in HER2 positive cohort (Cohort A) Safety profile is consistent with the known safety profile Careful monitoring and prompt intervention for ILD are required AE, adverse events; ILD, interstitial lung disease a2 patients were from cohort A, 1 from cohort B. b4 patients were from cohort A, 3 from cohort B and 1 from cohort C. CILD grades are the highest/most severe grade recorded in a patient. CRC: colorectal cancer, DOR: duration of response, ORR: objective response rate, OS: overall survival, PFS: progression free survival, TLR: top line results 18#19Dato-DXd: Breast cancer, NSCLC Presented interim results of TROPION-PanTumor01 study TNBC cohort at ESMO BC 2021 Presented interim results of TROPION-PanTumor01 study NSCLC cohort at ASCO 2021 TNBC cohort interim results Patients, n (%) a NSCLC cohort interim results Best change in SoD, % Best Overall Response (BICR) N=21 Objective response rate 9 (43) Dato-DXd Dose 80 CR/PR (confirmed) 5 (24) 4 mg/kg 6 mg/kg 60 60 CR/PR (pending confirmation) 4 (19) Patientsa (n=50) (n=50) 8 mg/kg (n=80) 40 40 Disease control rateb 20 (95) ORR, n (%) 12 (24) 13 (26) 19 (24) Progressive disease 1 (5) 20 20 0 CR/PR 10 (20) 11 (22) 19 (24) CR/PR (too early to be confirmed) 2 (4) 2 (4) 0 DCR, n (%) 38 (76) 35 (70) 64 (80) -20 PD, n (%) 7 (14) 10 (20) 7 (9) NE 10.5 9.0 -40 DOR, median (95% CI), mo (2.8-NE) (4.1-NE) (5.8-NE) -60 6 mg/kg PFS, median (95% CI), mob 4.3 (3.5-8.4) 6.9 5.2 (2.7-8.8) -80 -100 8 mg/kg CR, complete response; PR, partial response; SoD, sum of diameters, a Includes response evaluable patients who had ≥1 postbaseline tumor assessment or discontinued treatment. Postbaseline tumor assessments were not yet available for 3 patients at the data cutoff. One patient was not confirmed to have a target lesion per BICR and therefore had a best overall response of non-CR/non-PD; b Includes patients with a best overall response of CR, PR, stable disease, or non-CR/non-PD. Demonstrated promising efficacy and manageable safety profile in heavily treated patients with metastatic TNBC (4.1-7.1) BICR, blinded independent central review; CR, complete response; DCR, disease control rate; DOR, duration of response; NE, not evaluable; ORR, objective response rate; PD, progressive disease; PFS, progression-free survival; PR, partial response. a Includes response evaluable patients who had ≥1 postbaseline tumor assessment or discontinued treatment. b Median PFS was limited by immature duration of follow-up in the 4- and 6-mg/kg dosing cohorts. Demonstrated promising efficacy and manageable safety profile in patients with advanced or metastatic NSCLC The study data and analysis support 6mg/kg as the dose for the pivotal trial NSCLC: non small cell lung cancer, TNBC: triple negative breast cancer 19 Daiichi-Sankyo#20HER3-DXd: NSCLC EGFR mutated NSCLC Ph1 study (combination with osimertinib): First patient dosed in June Presented interim results of Ph1 monotherapy EGFR mutated NSCLC cohort at ASCO 2021 Ph1 efficacy Ph1 safety Febrile neutropenia Hypoxia Daiichi-Sankyo Confirmed ORR 39% Median Duration 6.9 Median PFS 8.2 TEAEs grade ≥3 in 25% of patients (N=81) of Response months months d Platelet count decreased Neutrophil count decreased e 40 20 Confirmed BOR CR PR SD PD NE + Ongoing treatment Fatigue Anemia Dyspnea -20 Best % change in SoD (BICR) from baseline -40 -60 + + + +++ + + + + + + + Ex19del Ex19del Ex19de L858R Y1069C L858R R958H Ex19del G8T3R NRAS G13D Ex19de Ex19del L861Q L858R T790M L718/ T790M T790M T790M T790M Exc0ns 67249 A8/13 C797S E7096 C7975 C797S EML4-ALK Multiple CCND1 ERBB4 V9031 EGFR CCNE1 PIK3CA EGFR KRAS G128 PIK3CA N345 CDKN2A G136RT FIK3CAH1047R PIK3CA G/62 PIK3CA H1047R METY1248H CCND3 Ex19del T790M T790M AGK-BRAF BRAF V600E + + G719x L858R L861Q G724S T790M C797S ECFR MET CDKN2A KRAS A146 ERBB4L1227R ERBB4M501V Lymphocyte count decreased 0% 25% 50% 75% 100% White blood cell count decreased Hypokalemia Data cutoff: September 24, 2020. Includes thrombocytopenia. Includes neutropenia. Includes hemoglobin decreased. 9 Includes leukopenia. Includes lymphopenia. 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 diameters. Data cutoff: September 24, 2020. 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 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. ©CDKN2A A143V; PIK3CA E542K, E545K, E726K; ERBB2 K200N; ERBB3 Q847*, Q849*. Demonstrated promising efficacy in patients with diverse mechanisms of EGFR TKI resistance NSCLC: non small cell lung cancer, TKI: tyrosine kinase inhibitor Demonstrated manageable safety profile and low rate of discontinuations due to adverse events -80 -100 EGFR Activating Mutations Other EGFR Mutations Amplifications T790M C797C C7975 Ex19dal Ex19del Ex19del L858R L718Q CCNE1 FGFR3-TACC3 Ex19del MET R988C Ex19del T790M Ex19del KRAS G12A, Q61R Non-EGFR Mutations and Fusions 20 20#213ADCs update Alpha update WCLC/ESMO 2021 News Flow Daiichi-Sankyo 21#22DS-5670 (COVID-19 mRNA vaccine) Characteristics of DS-5670 Lipid nanoparticle (LNP)-mRNA DS original cationic lipid is applied Most optimized lipid and lipid composition ratio are selected based on efficacy & safety perspectives It is expected to be effective against variants as well by targeting Receptor Binding Domain (RBD) instead of full spike protein of SARS-Cov-2 Participating in "Fundamental Research on the Control of a Novel Corona Virus (2019-nCoV)", an initiative supported by the Japan Agency for Medical Research and Development (AMED). Initiated Ph1/2 study in March 2021 and completed subject enrollment. Currently evaluating the safety, immunogenicity and recommended dose. Planning to initiate active-controlled, non-inferiority confirmatory study this year, enrolling several thousand subjects. Submission for approval and commercialization within CY2022 in the case when all regulatory requirements are satisfied. Daiichi-Sankyo 22#23DS-3201 (EZH1/2 inhibitor): Presented interim results of NHL Ph1 study at EHA DS3201-A-J101; NCT02732275 Patients with R/R NHL Age ≥20 (Japan) or ≥18 (US) years ECOG PS 0 or 1 Patients with ATL: positive test result for HTLV-1 Primary endpoints . . · Safety (including DLTS, TEAEs) Recommended phase 2 dose Pharmacokinetics Secondary endpoints Part 1: Dose Escalation Japan R/R NHL (all-comers) b 300 mg PO, QD RDE 250 mg PO, QD 200 mg PO, QD 150 mg PO, QD Part 2: Dose Expansion Japan and US R/R ATL Valemetostat 200 mg PO, QD R/R PTCL Valemetostat 200 mg PO, QD • Safety analysis: all NHL (N=77) • Safety and efficacy analyses: T-cell NHL (n=58) · Safety • Antitumor effecta o PTCL (n=44) o ATL (n=14) a According to the 2007 revised International Working Group Criteria for Malignant Lymphoma or "Definition, prognostic factors, treatment, and response criteria of adult T-cell leukemia-lymphoma: a proposal from an international consensus meeting." b Each dosage was tested with 3 patients. ATL: adult T-cell leukemia/lymphoma, EHA: European Hematology Association, NHL: non Hodgkin's lymphoma, PTCL: peripheral T-cell lymphoma, R/R: relapsed/refractory Daiichi-Sankyo 23#24DS-3201 Ph1: Efficacy results ATL a,c (N=14) Best Percent Change From Baseline in Sum of Area in Target Lesions All PTCLa Parameter (N=44) Best response, n (%) CR 12 (27.3) 4 (28.6) PR 12 (27.3) 4 (28.6) SD 5 (11.4) 2 (14.3) PD 8 (18.2) NE 1 (2.3) Not done 6 (13.6) ORR, n (%) 95% CI 24 (54.5) 38.8-69.6 3 (21.4) 0 (0) 1 (1.7) 8 (57.1) 28.9-82.3 DOR, median, weeks 56.0 (95% CI) (44.43, -) (6.14,-) TTR, median, weeks 8.14 (range) (4.1-24.1) 8.14 (7.3-84.1) PFS, median, weeks (95% CI) 52 (16.14, -) (8.14, -) Best % Change in Sum of Area From Baseline 100- 80 +1 +2 60 * 40 20 20 -20 * -40 -60 CR ✓ CRu PR SD Relapse/PD Daiichi-Sankyo -80 -100 *, ATL; +1, 146.9% increase from baseline; +2, 123.6% increase from baseline CR, complete response; CRu, complete response unconfirmed; PD, progressive disease; PR, partial response; SD, stable disease Data cutoff: 2 November 2020. Median follow-up times: PTCL, 19.93 (range, 3.1-68.1) weeks; ATL, 23.07 (range, 3.3-125) weeks. CR, complete response; DOR, duration of response; ORR, overall response rate; PD, progressive disease; PFS, progression-free survival; PR, partial response; SD, stable disease; TCL, T-cell lymphoma; TTR, time to first response. a For PTCL, 42 patients were treated with 200 mg, and 2 were treated with 150 mg. For ATL, 12 patients were treated with 200 mg, and 2 were treated with 150 mg. c Consists of 7 patients with acute and 7 patients with lymphomatous subtypes. Demonstrated ≥50% ORR and trend for durability of response in relapsed/refractory PTCL and ATL patients who have limited treatment options 24#25(occurring in ≥20% of patients DS-3201 Ph1: Most Common TEAEs Most Common TEAEs All Histologies (N=77) PTCL (N=44) with TCL)b All grades Grade ≥3 All grades Grade ≥3 All grades ATL (N=14) Grade ≥3 Platelet count decreasedd 47 (61.0) 13 (16.9) 21 (47.7) 5 (11.4) 9 (64.3) 3 (21.4) Dysgeusia 40 (51.9) 0 20 (45.5) 0 8 (57.1) 0 Anemia 31 (40.3) 9 (11.7) 15 (34.1) 6 (13.6) 5 (35.7) 1 (7.1) Neutrophil count decreased 27 (35.1) 18 (23.4) 13 (29.5) 8 (18.2) 6 (42.9) 5 (35.7) Alopecia 26 (33.8) 0 12 (27.3) 0 6 (42.9) 0 WBC count decreased 23 (29.9) 12 (15.6) 10 (22.7) 6 (13.6) 4 (28.6) 3 (21.4) Diarrhea 22 (28.6) 1 (1.3) 13 (29.5) 0 3 (21.4) 0 Lymphocyte count decreased 22 (28.6) 17 (22.1) 7 (15.9) 6 (13.6) 2 (14.3) 2 (14.3) ALT increased 16 (20.8) 1 (1.3) 7 (15.9) 0 3 (21.4) Nausea 16 (20.8) 0 11 (25.0) 0 3 (21.4) 1 (7.1) 0 Daiichi-Sankyo ALT alanine aminotransferase; BCL, B-cell lymphoma; CTCAE, Common Terminology Criteria for Adverse Events; TEAE, treatment emergent adverse events; WBC, white blood cell. a Study sites could choose to enter thrombocytopenia or platelet count decreased as a term. b In order of frequency reported for patients with TCL (n=58). c Including 19 patients with BCLs. d Grade 3 platelet count decreased, CTCAE 5.0 definition: <50,000-25,000/mm3; <50.0-25.0 x 109/L. Demonstrated acceptable safety profile by appropriate monitoring and management of adverse events Grade ≥3 platelet count decreasea, and thrombocytopenia occurred in 13 patients (16.9%) and 2 patients (2.6%), respectively ➤ The median time to platelet count reduction to ≤50x109/L from the first dose was 15 days, and the median time to platelet count recovery to ≥50x109/L was 12 days 6 patients (9.8%) experienced dose interruption or reduction due to platelet count decrease/thrombocytopenia, but no patients discontinued treatment due to platelet count decrease/thrombocytopenia 25#26DS-3201 ATL/PTCL development plan Clinical studies for ATL/PTCL Region NHL Ph1 study ATL, PTCL and others (NCT02732275/JapicCTI-163173) US/JP R/R ATL Registrational Ph2 study JP (NCT04102150/JapicCTI-194964) R/R PTCL Registrational Ph2 study Global VALENTINE-PTCL01 (NCT04703192/jRCT2071200095) Status Presented interim data at EHA 2021 Obtained TLR in July ➤ Preparation underway for filing in Japan in FY2021 2H First patient dosed in June. SAKIGAKE designation in Japan ATL: adult T-cell leukemia/lymphoma, EHA: European Hematology Association, NHL: non Hodgkin's lymphoma, PTCL: peripheral T-cell lymphoma, R/R: relapsed/refractory, TLR: top line results Daiichi-Sankyo 26#27Other Alpha update Oncology DS-1594 (Menin-MLL binding inhibitor) AML/ALL Ph1 initiation in US (April) Pexidartinib (CSF-1/KIT/FLT3 inhibitor) Tenosynovial giant cell tumor Ph2 initiation in JP (April) Specialty Medicine DS-6016 (anti-ALK2 antibody) Fibrodysplasia ossificans progressiva Ph1 initiation in JP (April) TarligeⓇ (a28 ligand) Daiichi-Sankyo Central neuropathic pain, JP submission (May) VN-0200 (Vaccine) RS virus, Ph1 initiation in JP (June) DS-2319 (Nafamostat inhalation) COVID-19, development discontinued (June) DS-2741 (anti-Orai1 antibody) atopic dermatitis, development discontinued (June) 27#283ADCs update Alpha update WCLC/ESMO 2021 News Flow Daiichi-Sankyo 28#29Planned Presentation at WCLC/ESMO 2021 WCLC 2021: 9/8-14 (Virtual) Dato-DXd TROPION-Pan Tumor01 (Ph1), NSCLC cohort data update Mini oral presentation Daiichi-Sankyo ESMO 2021: 9/16-21 (Virtual) EnhertuⓇ Dato-DXd DS-7300 DESTINY-Lung01 (HER2 mutated/overexpressing, 2L+, Ph2), HER2 mutated cohort data Late breaking session* DESTINY-Breast01 (HER2 positive, 3L, Ph2), updated OS data Poster presentation TROPION-PanTumor01 (Ph1 NSCLC cohort), sub-analysis of patients with actionable mutations ◆ Late breaking session* Solid tumor Ph1/2, Ph1 dose escalation data Oral presentation NSCLC: non small cell lung cancer, OS: overall survival * Final decision for the acceptance of late breaking abstract will be made after Aug 17 WCLC/ESMO IR event is planned on Sep 22 morning in JP time featuring Ken Takeshita Global R&D Head 29 20#303ADCs update Alpha update WCLC/ESMO 2021 News Flow 30 30 Daiichi-Sankyo#31FY2021 News Flow Daiichi-Sankyo As of July 2021 Planned publications WCLC (Sep 8-14) Dato-DXd TROPION-Pan Tumor01: Ph1 NSCLC cohort Updated data ESMO (Sep 16-21) EnhertuⓇ DESTINY-Lung01: HER2mutated/overexpressing NSCLC, 2L, Ph2 HER2 mutated cohort data* DESTINY-Breast01: HER2 positive BC, 3L, Ph2 Updated OS data TROPION-PanTumor01: Ph1 NSCLC cohort Sub-analysis of patients with actionable mutations* Regulatory decisions Atrial fibrillation in the very elderly Lixiana® Japan: FY2021 Q2 Ischemic stroke Japan: FY2021 Q3 EfientⓇ • Planned regulatory submissions Enhertu DS-3201 DESTINY-Gastric01/02: HER2 positive GC, 2/3L, Ph2 Europe: FY2021 2H Registrational Ph2: ATL/L Japan: FY2021 2H Dato-DXd Solid tumor Ph1/2 DS-7300 Ph1 dose escalation data * Final decision for the acceptance of late breaking abstract will be made after Aug 17 Key data readouts EnhertuⓇ Quizartinib DESTINY-Breast03: HER2 positive BC, 2L, Ph3 FY2021 Q2 DESTINY-Breast04: HER2 low BC, post chemo, Ph3 FY2021 Q4 QUANTUM-First: AML, 1L, Ph3 FY2021 Q3 Underlined: New or updated from ASCO Highlight AML: acute myeloid leukemia, ATL: adult T-cell leukemia/lymphoma, BC: breast cancer, NSCLC: non small cell lung cancer, OS: overall survival 31#321 FY2021 Q1 Financial Results 2 Business Update 3 R&D Update 4 Appendix Daiichi-Sankyo 32#33Major R&D Milestones in FY2021 (3ADCs) As of July 2021 Daiichi-Sankyo FY2021 Q1 Q2 Q3 Q4 TLR anticipated TLR anticipated Study started TLR obtained Study started TLR obtained Submission anticipated (Europe) Project BC ENHERTUⓇ GC NSCLC Dato-DXd HER3-DXd Target Indications [phase, study name] HER2+, 2L [P3, DESTINY-Breast03] HER2 low, post chemo [P3, DESTINY-Breast04] HER2+, 1L [P3, DESTINY-Breast09] HER2+, 2L [P2, DESTINY-Gastric02] HER2+, 2L [P3, DESTINY-Gastric04] HER2+/mutant [P2, DESTINY-Lung01] HER2+, combination [P1b, DESTINY-Lung03] TNBC, durvalumab combo [P1b/2, BEGONIA] EGFR mutated NSCLC, osimertinib combo [P1] Red underlined: new or updated from FY2020 Q4 BC: breast cancer, GC: gastric cancer, NSCLC: non-small cell lung cancer, TLR: Top Line Results, TNBC: triple negative breast cancer Study started Study started Study start planned 33#34Major R&D Milestones in FY2021 (Alpha) FY2021 Project Target Indications [phase, study name, region] Q1 Q2 Quizartinib AML, 1L [P3, JP/US/EU/Asia] Pexidartinib Tenosynovial giant cell tumor [P2, JP] Teserpaturev/G47A Malignant glioma [IIS, JP] Study started Approved ATL/lymphoma [P2 registration, JP] DS-3201 PTCL [P2 registration, JP/US/EU/Asia] AML, ALL [P1/2, US] As of July 2021 Q3 Q4 TLR anticipated TLR obtained Submission anticipated (Japan) Study started Study started Approval anticipated Approval anticipated DS-1594 R Lixiana R Efient Tarlige® AF in the very elderly [P3, ELDERCARE-AF, JP] Ischemic stroke [P3, PRASTRO III, JP] Central neuropathic pain [P3, JP] Submitted DS-6016 Fibrodysplasia Ossificans Progressiva [P1, JP] Study started VN-0200 RS virus vaccine [P1, JP] Study started Red underlined: new or updated from FY2020 Q4 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, TLR: Top Line Results Daiichi-Sankyo 34#35Major R&D Pipeline: 3ADCs Daiichi-Sankyo As of July 2021 Submitted (JP/US) NSCLC, TNBC, HR+ BC TROPION-PanTumor01 (JP/US/EU/Asia) NSCLC (w/o actionable mutation, pembrolizumab combo) TROPION-Lung02 (JP/US/EU/Asia) NSCLC (w/o actionable mutation, durvalumab combo) TROPION-Lung04 (US/EU/Asia) TNBC (durvalumab combo) BEGONIA (JP/US/EU/Asia) NSCLC (JP/US)EGFR mutated NSCLC (osimertinib combo) (JP/US) BC ENHERTU® Dato-DXd HER3-DXd Phase 1 (US/EU/Asia) HER2+ BC 2L~/1L DESTINY-Breast07 (US/EU/Asia) HER2 low BC chemo naïve/ post chemo DESTINY-Breast08 (US/EU/Asia) HER2+ GC combo, 2L~/1L DESTINY-Gastric03 (EU/Asia)HER2+ NSCLC (durvalumab combo) 1L DESTINY-Lung03 (US/EU) BC, bladder (nivolumab combo) (US/EU) BC, NSCLC (pembrolizumab combo) Phase 2 (US/EU/Asia) TNBC (durvalumab combo) BEGONIA (US/EU) HER2+ GC 2L DESTINY-Gastric02 Phase 3 (JP/US/EU/Asia) HER2+ BC 3L DESTINY-Breast02 (JP/US/EU/Asia) HER2+ BC 2L DESTINY-Breast03 (JP/US/EU)HER2+/mutated NSCLC 2L~(JP/US/EU/Asia) HER2 low BC DESTINY-Lung01 (JP/US/EU/Asia) HER2 mutated NSCLC 2L~ DESTINY-Lung02 (US/EU/Asia) NSCLC (durvalumab combo) 2L~ HUDSON (JP/US/EU) HER2+ CRC 3L DESTINY-CRC01 (JP/US/EU/Asia) HER2+ CRC 3L DESTINY-CRC02 (US/EU/Asia) HER2 mutated tumor DESTINY-PanTumor01 (US/EU/Asia) HER2 expressing tumor DESTINY-PanTumor02 (JP/US/EU/Asia) NSCLC (w/ actionable mutation) TROPION-Lung05 (JP/US/EU/Asia) EGFR mutated NSCLC HERTHENA-Lung01 (JP/US/EU) CRC 3L post chemo DESTINY-Breast04 (JP/US/EU/Asia) HER2+ BC post neoadjuvant DESTINY-Breast05 (JP/US/EU/Asia) HER2 low BC chemo naive DESTINY-Breast06 (US) HER2+ BC 1L DESTINY-Breast09 (JP/EU/Asia) HER2+ GC 2L DESTINY-Gastric04 (JP/US/EU/Asia) NSCLC (w/o actionable mutation) TROPION-Lung01 BC: breast cancer, CRC: colorectal cancer, GC: gastric cancer, NSCLC: non-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) 35#36Major R&D Pipeline: Alpha Daiichi-Sankyo Phase 1 B7-H3-directed ADC DS-7300 (JP/US) Solid tumors DS-6157 (JP/US) GPR20-directed ADC GIST DS-6000 (US) CDH6-directed ADC Renal cell carcinoma, ovarian cancer DS-1055 (JP/US) Anti-GARP antibody Solid tumors DS-1211 (US) DS-3201 (JP/US) EZH1/2 inhibitor Non-Hodgkin's lymphomas PLX2853 (US) BET inhibitor AML PLX2853 (US) BET inhibitor Solid tumor PLX2853 (US) BET inhibitor DS-3201 (JP) Phase 2 EZH1/2 inhibitor ATL/L DS-3201 (JP/US/EU/Asia) EZH1/2 inhibitor PTCL DS-1001 (JP) Mutant IDH1 inhibitor Glioma DS-5141 (JP) ENA oligonucleotide Gynecologic neoplasms, ovarian cancer DMD PLX2853 (US) Phase 3 Quizartinib (JP/US/EU/Asia) FLT3 inhibitor 1L AML Pexidartinib (JP/Asia) CSF-1/KIT/FLT3 inhibitor Tenosynovial giant cell tumor Minnebro (JP) MR blocker Diabetic nephropathy VN-0102/JVC-001 (JP) Measles mumps rubella combined vaccine Tarlige (JP) As of July 2021 a28 Ligands Submitted Central neuropathic pain Lixiana (JP) FXa inhibitor AF in the very elderly Efient (JP) ADP receptor inhibitor Ischemic stroke VN-0107/MEDI3250 (JP) Live attenuated influenza vaccine nasal spray TNAP inhibitor Pseudoxanthoma elasticum DS-6016 (JP) Anti-ALK2 antibody DS-5670 (JP) mRNA vaccine BET inhibitor Prostate cancer DS-1594 (US) Menin-MLL binding inhibitor VN-0200 (JP) Fibrodysplasia Ossificans Progressiva AML, ALL RS virus vaccine COVID-19 Oncology RS virus Specialty medicine Vaccine AF: atrial fibrillation, ALL: acute lymphoblastic leukemia, AML: acute myeloid leukemia, ATL/L: adult T-cell leukemia/lymphoma, DMD: Duchenne muscular dystrophy, GIST: gastrointestinal stromal tumor, 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) 36#37Contact address regarding this material Daiichi Sankyo Co., Ltd. Corporate Communications Department TEL: +81-3-6225-1125 Email: [email protected]