#1Passion for Innovation. Compassion for Patients™M FY2023 Q1 Financial Results Presentation DAIICHI SANKYO CO., LTD. Koji Ogawa Executive Officer, CFO July 31, 2023 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 1 FY2023 Q1 Financial Results 2 Business Update 3 R&D Update 4 Appendix Daiichi-Sankyo 3#4Overview of FY2023 Q1 Results FY2022 Q1 FY2023 Q1 YOY (Bn JPY) Results Results Revenue Cost of sales * 280.3 350.8 +25.2% 70.5 74.7 93.6 18.9 SG&A expenses 96.3 135.6 39.3 R&D expenses✶ 74.9 77.2 2.2 Core operating profit* 34.4 44.5 +29.4% 10.1 Temporary income* 0.0 0.5 0.5 Temporary expenses 0.9 0.9 Operating profit 34.4 44.0 +28.1% 9.7 Profit before tax 29.4 52.1 22.7 Profit attributable to owners 18.9 57.0 +202.4% 38.2 of the Company Currency Rate USD/JPY EUR/JPY 129.57 138.10 137.37 149.46 +7.80 +11.36 Daiichi-Sankyo *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 data 4#5Revenue Increased by 70.5 Bn JPY (Increased by 59.0 Bn JPY excl. forex impact) FY2022 Q1 Results Japan Business (incl. Innovative Pharmaceuticals, Generic, Vaccines, OTC) Oncology Business*1 American Regent EU Specialty Business ASCA (Asia, South and Central America) Enhertu, Dato-DXd*2 Upfront/Quid Payment & Regulatory/Sales Milestone Forex Impact*3 FY2023 Q1 Results Daiichi-Sankyo (Bn JPY) Positive Factors Negative Factors 280.3 12.2 *39.1 Japan Business Unit Lixiana +2.8 Tarlige +2.8 Enhertu +1.9 Efient +1.3 Daiichi Sankyo Healthcare +1.9 0.8 Oncology Business *1 Unit Enhertu +38.7 1.2 American Regent Unit 6.9 Venofer +2.5 Injectafer -1.7 1.2 | EU Specialty Business Unit Lixiana 11.5 Nilemdo/ Nustendi +1.2 +1.5 Olmesartan -1.0 350.8 ASCA (Asia, South and Central America) Business Unit Positive Factors Negative Factors Enhertu +5.5 *1 Revenue for Daiichi Sankyo, Inc. and Daiichi Sankyo Europe's oncology products *2 Dato-DXd: Datopotamab deruxtecan (DS-1062) *3 Forex impact USD: +6.4, EUR: +4.5, ASCA: +0.7 5#6Core Operating Profit Increased by 10.1 Bn JPY (Increased by 10.0 Bn JPY excl. forex impact) FY2022 Q1 Results 34.4 Revenue 70.5 Cost of Sales SG&A Expenses 34.1 Revenue +70.5 incl. forex impact of +11.5 Cost of Sales +15.6 15.6 Daiichi-Sankyo (Bn JPY) Increase in cost of sales due to the revenue increase SG&A Expenses +34.1 Increase in expenses related to Enhertu due to an increase in profit share of gross profit with AstraZeneca R&D Expenses Forex Impact 0.8 Forex Impact +11.5 (Profit Decreased) 11.5 Cost of Sales +3.3 SG&A Expenses +5.2 FY2023 Q1 Results 44.5 R&D Expenses +3.0 Positive Factors Negative Factors 6#7Profit Attributable to Owners of the Company FY2022 Q1 Results 18.9 Core Operating 10.1 Profit Temporary Revenue/ Expenses Financial Income/ Expenses etc. Income Taxes etc. FY2023 Q1 Results 0.4 13.0 Increased by 38.2 Bn JPY Daiichi-Sankyo (Bn JPY) Financial Income/Expenses etc. +13.0 (Profit Increased) Improvement in forex gains/losses Improvement in investment securities valuation gains/losses Increase in interest income +4.9 +3.9 +2.9 Income Taxes etc. 15.4 -15.4 FY2022 Q1 Results FY2023 Q1 Results YOY 57.0 Profit before Tax 29.4 52.1 +22.7 Positive Factors Negative Factors Income Taxes etc. 10.6 -4.9 -15.4 Tax rate 35.9% -9.4% -45.3% 7#8Revenue: Business Units (incl. Forex Impact) (Bn JPY) FY2022 Q1 Results FY2023 Q1 Results YOY Japan Business 109.0 119.0 +10.0 Daiichi Sankyo Healthcare 15.3 17.1 +1.9 Oncolgy Business 27.5 70.6 +43.1 Enhertu 26.7 69.4 +42.7 Turalio 0.8 1.2 +0.4 American Regent 47.0 50.7 +3.6 Injectafer 14.1 13.2 -0.9 Venofer 12.4 15.8 +3.4 GE injectables EU Specialty Business 17.6 18.3 +0.8 37.1 41.5 +4.4 Lixiana 28.6 32.3 +3.7 Nilemdo/Nustendi 1.3 3.0 +1.7 Olmesartan 5.4 4.7 -0.7 ASCA (Asia, South and Central America) Business 31.9 39.5 +7.6 Currency Rate Daiichi-Sankyo USD/JPY 129.57 137.37 +7.80 EUR/JPY 138.10 149.46 +11.36 8#9Revenue: Major Products in Japan Daiichi-Sankyo (Bn JPY) FY2022 Q1 FY2023 Q1 YOY Results Results Lixiana anticoagulant 25.1 27.9 +2.8 Pralia Tarlige treatment for osteoporosis/ inhibitor of the progression of bone erosion associated with rheumatoid arthritis pain treatment 9.9 10.7 +0.8 8.9 11.7 +2.8 Vimpat anti-epileptic agent 5.3 6.4 +1.1 treatment for bone complications caused by bone Ranmark 4.9 5.0 +0.0 metastases from tumors Tenelia type 2 diabetes mellitus treatment 5.6 5.3 -0.3 anti-cancer agent Enhertu 2.4 4.4 +1.9 (HER2-directed antibody drug conjugate) Efient antiplatelet agent 4.9 6.1 +1.3 Canalia type 2 diabetes mellitus treatment 4.1 4.1 +0.1 Loxonin anti-inflammatory analgesic 4.6 4.0 -0.6 Emgality prophylaxis of migraine attacks 1.4 1.7 +0.3 9#10Agenda 1 FY2023 Q1 Financial Results 2 Business Update 3 R&D Update 4 Appendix Daiichi-Sankyo 10#11ENHERTU Revenue FY2023 Q1 Results YOY FY2023 Forecast (Bn JPY) <Reference> YoY Total Consideration Daiichi-Sankyo Product Sales 81.7 50.4 320.0 112.5 Japan US Europe ASCA 4.4 1.9 19.9 8.2 51.6 31.5 195.1 50.5 17.8 11.1 75.8 38.8 8.0 5.8 29.2 15.1 *1 *1 Upfront payment Regulatory milestone payment US HER2+ Breast Cancer 3L EU HER2+ Breast Cancer 3L 2.5 9.8 149.0 *1 *1 2.1 -1.3 11.6 -15.1 136.3 0.2 0.1 US HER2+ Gastric Cancer 2L + 3L 0.2 I I I 0.9 13.7 0.5 7.9 0.8 12.1 US HER2+ Breast Cancer 2L 0.2 -2.6 0.9 -2.6 13.1 EU HER2+ Breast Cancer 2L 0.2 0.2 0.7 -2.0 10.1 *1 Revenue recognized in each period *2 Converted with assumed forex rate for FY2023 of 130 JPY to 1 USD US HER2-low Breast Cancer (post-chemo) 0.5 0.5 1.8 -5.5 27.7 EU HER2-low Breast Cancer (post-chemo) 0.3 0.3 1.3 -3.9 19.8 EU HER2+ Gastric Cancer 2L 0.1 0.1 0.3 -0.9 4.8 US HER2 Mutant NSCLC 2L 0.3 0.3 1.1 -3.4 17.3 EU HER2 Mutant NSCLC 2L 3.2 3.2 9.8 *2 Quid related payment Sales milestone payment *1 0.3 1.1 *1 17.2 *3 Milestone of 200Mn USD for achieving annual product sales of 2 Bn USD in co- commercialization territory with AstraZenceca. (Total amount to be recognized in FY2023) Ref. Total sales milestone payment: 1.75 Bn USD (Max) *3 26.0 12.8 39.2 Total 86.6 49.2 368.6 110.2 341.7 11#12ENHERTU Performance in Each Region (US, EU) Global product sales: FY2023 Q1 results 81.7 Bn JPY (YOY +50.4 Bn JPY) FY2023 forecast 320.0 Bn JPY (YOY +112.5 Bn JPY) >ENHERTU US trastuzumab deruxtecan 51.6 Bn JPY 20.0 Bn JPY 6.7 Bn JPY 17.8 Bn JPY FY2022 Q1 FY2023 Q1 FY2022 Q1 FY2023 Q1 US Europe Daiichi-Sankyo Product sales: FY2023Q1 results 51.6 Bn JPY (375 Mn USD) FY2023 forecast 195.1 Bn JPY (1.5 Bn USD) Indication: HER2+ mBC 2L+, HER2 low mBC (post-chemo), HER2+ mGC 2L+, HER2 mutant mNSCLC 2L+ Market share status HER2+ mBC 2L: Maintaining No.1 new patient share HER2 low mBC: Maintaining No.1 new patient share and growing further HER2+ MGC 2L: Maintaining No.1 new patient share HER2 mutant mNSCLC 2L: Maintaining No.1 new patient share Europe Product sales: FY2023Q1 results 17.8 Bn JPY (130 Mn USD) FY2023 forecast 75.8 Bn JPY (583 Mn USD) Indication: HER2+ mBC 2L+, HER2 low mBC (post-chemo), HER2+ MGC 2L+ Market share status HER2+ MBC 2L: Maintaining No.1 new patient share in France, Germany and Spain HER2 low mBC: Achieved No.1 new patient share in France and Germany Other progress Launched in Italy (Jul. 2023) 12#13ENHERTU® Performance in Each Region (Japan, ASCA) Global product sales: FY2023 Q1 results 81.7 Bn JPY (YOY +50.4 Bn JPY) FY2023 forecast 320.0 Bn JPY (YOY +112.5 Bn JPY) >ENHERTU trastuzumab deruxtecan Japan Product sales: FY2023Q1 results 4.4 Bn JPY FY2023 forecast 19.9 Bn JPY Indication: HER2+ mBC 2L+, HER2 low mBC (post-chemo), HER2+ MGC 3L 4.4 Bn JPY 2.4 Bn JPY 2.2 Bn JPY Market share status 8.0 Bn JPY FY2022 Q1 FY2023 Q1 FY2022 Q1 FY2023 Q1 Japan ASCA ASCA HER2+ MBC 2L: Achieved No.1 new patient share HER2 low mBC: Steady uptake in capturing new patient share HER2+ MGC 3L: Maintaining No.1 new patient share Product sales: FY2023Q1 results 8.0 Bn JPY FY2023 forecast 29.2 Bn JPY Indication: HER2+ mBC 2L+, HER2 low mBC (post-chemo), HER2+ mGC 3L Market share status Sales growing in Brazil, Hong Kong and Taiwan Other progress China: Launched for HER2+ mBC 2L (Jun. 2023), Approved for HER2 low mBC (post-chemo) and started promotion (Jul. 2023) Daiichi-Sankyo 13#14Initiatives Related to Profit Growth for Current Business and Products in Japan Enhance product portfolio VANFLYTAⓇ Anti-Cancer Agent /FLT3 Inhibitor ➤ Obtained partial change approval for acute myeloid leukemia (AML) 1L therapy in May 2023 Changed from "relapsed/refractory FLT3-ITD positive AML" to "FLT3-ITD positive AML" Daiichi-Sankyo TARLIGEⓇ Orally Disintegrating Tablet Pain Treatment ➤ Launched in May 2023 100線 100 100m OITUSL U-HOD 2.5mg Tarlige OD 2.5mg タリージェOD錠5mg タリージェOD錠10mg ROMIUMONE OM/U Tarlige OD 5mg Tarlige OD 10mg mirogan mirogain miregadalin 神經障害性所痛治療劑 9U-BIODE 15mg ミロガンベシル酸製剤 Tarlige mirogabalin 1002 OD 15mg Enhance transformation into a profit structure focused on patented drugs Stock Transfer of DAIICHI SANKYO ESPHA CO., LTD. (Concluded an agreement in May 2023) ➤ Transferee: Qol Holdings Co., Ltd. Consideration for transfer: 25.0 Bn JPY Date of transfer (planned) : October 1, 2023 (30% of the shares held by the Company), April 1, 2024 (21% of the shares held by the Company) The date of execution of the transfer of the remaining 49% of the Company's shares will be determined by separate negotiation. 14#15Agenda 1 FY2023 Q1 Financial Results 2 Business Update 3 R&D Update 4 Appendix Daiichi-Sankyo 15#165DXd-ADCs Update Next Wave Update News Flow Daiichi-Sankyo 16#17From "3 and Alpha" to "5DXd-ADCs and Next Wave" ENHERTU Dato-DXd BADCs 5DXd-ADCS HER3-DXd & DS-7300 (I-DXd) Alpha & Next Wave DS-6000 (R-DXd) Oncology Specialty Medicine & Vaccine Maximize 5DXd-ADCs Values Next Pillars Daiichi-Sankyo ENHERTU®: trastuzumab deruxtecan (International Nonproprietary Name: INN), T-DXd, DS-8201 (HER2-directed ADC), Dato-DXd: datopotamab deruxtecan (INN), DS-1062 (TROP2-directed ADC), HER3-DXd: patritumab deruxtecan (INN), U3-1402 (HER3-directed ADC), DS-7300: ifinatamab deruxtecan, I-DXd (B7-H3-directed ADC), DS-6000: raludotatug deruxtecan, R-DXd (CDH6-directed ADC) 17#18ENHERTU® Promising antitumor activity in HER2+ mCRC patients DESTINY-CRC02 study (ASCO 2023) DESTINY-CRC02 study suggests 5.4 mg/kg is the optimal dose Best % Change in Sum of Diameters from Baseline 100. T-DXd 5.4 mg/kg Q3W Total (N = 82) 80- 60. 40 20 ་ -20- -40. -60. HER2 statusa : IHC 3+ CORR 37.8% [27.3-49.2]b -80- IHC 2+/ISH+ Patients -100- RAS Mutant Best minimum change, % Both doses evaluated confirmed the promising antitumor activity Best % Change in Sum of Diameters from Baseline Daiichi-Sankyo 100- 80. T-DXd 6.4 mg/kg Q3W Stage 1 (N = 40) CORR 27.5% [14.6-43.9] b 60 40 20 20 0 -20- -40- -60- -80- Patients -100 Best minimum change, % Antitumor activity (ORR) in patients with and without RAS mutation at the 5.4 mg/kg dose The most common adverse events seen with ENHERTUⓇ in this study were nausea, fatigue, neutropenia, anemia comparable to the known profile of T-DXd ■There was no grade ≥3 ILD/pneumonitis cases in the 5.4 mg/kg arm Efficacy and safety profile of both cohorts favors the 5.4 mg/kg dose a HER2 status was assessed by central laboratory. b 95% confidence interval. CORR: confirmed objective response rate, IHC: immunohistochemistry, ILD: interstitial lung disease, ISH: in situ hybridization, mCRC: metastatic colorectal cancer 18 Q3W: every 3 weeks, T-DXd: trastuzumab deruxtecan, TEAE: treatment emergent adverse events#19Potential new treatment option for HER2 expressing ENHERTU® Solid tumors DESTINY-PanTumor02 study (ASCO 2023) Demonstrated clinically meaningful activity across a broad range of HER2 expressing solid tumors (2L+) 100 90 80 75.0 84.6 Objective Response Rate by HER2 status 70 60 50.0 50 40.0 Confirmed ORR, % 40 30 20 20 28 57.5 63.6 56.3 47.1 45.0 36.8 10 All IHC 3+ IHC 2+ All IHC 3+ IHC 2+ All IHC 3+ IHC 2+ All IHC 3+ 22.0 IHC 2+ All IHC 3+ IHC 2+ 4.0 5.3 0.0 0.0 0 n= 40 8 20 Cervical 40 13 17 Endometrial 40 11 19 Ovarian 41 16 14 BTC 25 2 19 Pancreatic 41 56.3 39.0 35.0 30.0 18.8 All IHC 3+ IHC 2+ All 61.3 44.4 37.1 27.2 IHC 3+ IHC 2+00 All IHC 3+ IHC 2+ 16 20 Bladder 40 9 16 Othera 267 75 125 Total Median DOR, months (95% CI) All patients (N=99) 11.8 (9.8-NE) ■ORR: 37.1% in all patients (n=267) and 61.3% in patients with IHC 3+ (n=75) IHC 3+ (n=46) 22.1 (9.3-NE) IHC 2+ (n=34) 9.8 (4.2-12.6) ■DOR: median DoR 11.8 months in all patients responded (n=99) and 22.1 months in patients with IHC 3+ (n=46) ■Most common adverse events of ENHERTUⓇ in this study were neutropenia, anemia, fatigue, nausea, thrombocytopenia which were comparable to the known profile seen with T-DXd Majority of ILD/pneumonitis events were grade 1 or 2; one grade 3 event and one grade 5 event were observed a Analysis of DoR was performed in patients with objective response b Responses in extramammary Paget's disease, head and neck cancer, oropharyngeal neoplasm, and salivary gland cancer. BTC: biliary tract cancer, Cl: confidence interval, DoR: duration of response, IHC: immunohistochemistry, ILD: interstitial lung disease, NE: non-estimable; ORR, objective response rate. 19 Daiichi-Sankyo#20ENHERTU® Primary analysis of DESTINY-PanTumor02 study TLR from the primary analysis was acquired in Jul 2023 Daiichi-Sankyo Interim Analysis Primary Analysis 276 Cervical cancer 576 Endometrial cancer 276 Ovarian cancer T-DXd 5.4 mg/kg Biliary tract cancer q3w Pancreatic cancer Bladder cancer Other tumorsa Primary endpoint: confirmed ORR (investigator) ➤ Secondary endpoint: DoR, DCR, PFS, OS, safety Reported at ASCO 2023 Continued to show durable responses for ORR and DoR ■ Demonstrated clinically meaningful PFS and OS results ■ILD rates and severity were consistent with those observed in other trials of ENHERTU. ■Data will be presented at an upcoming medical meeting ■Discussions with health authorities are ongoing Obtained in Jul 2023 a Patients with tumors that express HER2, excluding tumors in the tumor-specific cohorts, and breast cancer, non-small cell lung cancer, gastric cancer, and colorectal cancer. ASCO: American Society of Clinical Oncology, DCR: disease control rate, DoR: duration of response, ORR: objective response rate, OS: overall survival, PFS: progression-free survival, q3w: every 3 weeks, T-DXd: trastuzumab deruxtecan 20 20#21Best change in sum of diameters from baseline, % 80 60 40 20 20 Dato-DXd Encouraging Combination Data in 1L NSCLC TROPION-Lung02 study (ASCO 2023) Dato-DXd + Pembrolizumab (Doublet) and additional platinum chemotherapy (Triplet) demonstrated encouraging antitumor activity All patients (n=124)a Doublet Triplet ORR 38% [26-51]d ORR 49% [37-61]d 80 60 40 20 1L patients only (n=84)a Doublet Triplet ORR 50% [32-68]d ORR 57% [42-70]d 0 ++ otokollok lok slok Holotok Molok ****ololok ok ok ** **** *ok olololololololololok ok okolokolok * *olok > + +++ +++++ 가아아아아아 아아아ok жok Daiichi-Sankyo ****** ***** ** ****** ******* ** * * ******* ***** ***: **** ** 0 ********* + +++ ++ + -20 ++++ + + + ++ ++ + ++ -40 ++++ +++ + + + -60 ++++ +++ + -20 -40 -60 Doublet Triplet + Treatment ongoing * Dato-DXd 6 mg/kg b + + +++ +++. +++++++++++ + *** *** ** -80 -100 -80 -100 The left graph includes the patients with NSCLC in the 1L and 2L+ settings Data cutoff: April 7, 2023 The most common adverse events of Dato-DXd in this study were stomatitis, nausea, anemia, fatigue which were comparable to the known profile of Dato-DXd ■ Observed stomatitis and ILD/pneumonitis as AESI, predominantly grade 1 or 2 (no grade 4 or 5 ILD/pneumonitis observed) a Patients with no baseline target lesions or no postbaseline tumor assessments were excluded from the waterfall plots. b Planned dose level. © Responses pending confirmation. d 95% confidence interval 1L: first line, AESI: adverse events of special interest, ASCO: American Society of Clinical Oncology, Cl: confidence interval, ILD: interstitial lung disease, NSCLC: non small cell lung cancer, ORR: objective response rate, TEAE: treatment 21 emergent adverse events#22Dato-DXd Path for establishing 2L/3L treatment in NSCLC TROPION-Lung 01 study Disclosed TLR in July 2023 Daiichi-Sankyo Major Ph3 Clinical Studies of Dato-DXd in NSCLC Advanced/Metastatic Advanced or Dato-DXd 6.0 mg/kg 1L 24 2L 3L Randomization metastatic 1:1 NSCLC 2L/3L Docetaxel 75 mg/m² N = 600 TROPION- Lung07 (PD-L1 <50%) Primary: PFS, OS Secondary: ORR, DOR, DCR, PK, safety etc. NSCLC without AGA Demonstrated statistically significant improvement in PFS TROPION- Lung08 (PD-L1 ≥ 50%) TROPION- Lung01 ■No new safety signals identified, all grade ILD was generally consistent with prior clinical trials with the majority being grade1 or 2. Grade 5 ILD events were observed ■Proceeding to file the data with FDA NSCLC with AGA AGA: actionable genomic alteration, DCR: Disease Control Rate, DoR: Duration of Response, FDA: U.S. Food and Drug Administration, ILD: interstitial lung disease, NSCLC: Non-small Cell Lung Cancer, ORR: Overall Response Rate, OS: Overall Survival, PFS: Progression Free Survival, PK: Pharmacokinetics, TLR: Top Line Results 22#23HER3-DXD HERTHENA-Lung01 study Planned regulatory submission in US in FY2023 H2 Clinical studies of HER3-DXd in EGFR mutated NSCLC Advanced/Metastatic 1L 2L 3L HERTHENA- Lung02 Ph3 (HER3-DXd mono vs chemo) HERTHENA- Lung01 registrational Ph2 ■ Announced the TLR outline in FY2022 Q4 earnings call • · Daiichi-Sankyo 5.6 mg/kg dose showed durable responses in patients with metastatic or locally advanced EGFR mutated NSCLC previously treated with an EGFR TKI and PBC No new safety concerns identified ■ Clinical data to be presented at WCLC in Sep 2023 ■ Other ongoing EGFR mutated NSCLC studies: HERTHENA-Lung02 study (2L, Ph3) • Osimertinib combination Ph1b study Osimertinib combination Ph1b NSCLC: non-small cell lung cancer, PBC: platinum-based chemotherapy, TKI: tyrosine kinase inhibitor, WCLC: World Conference of Lung Cancer 23#245DXd-ADCS Additional updates in clinical studies and regulatory communications Daiichi-Sankyo ENHERTU® ■Jun 2023: Combination study with DS-1103 (anti-SIRPα antibody) started ■Jul 2023: Approved in China for chemo treated HER2 low BC (DESTINY-Breast04) DS-7300 ■ Apr 2023: Orphan drug designation granted by FDA for SCLC BC: breast cancer, FDA: U.S. Food and Drug Administration, SCLC: small cell lung cancer 24#255DXd-ADCs Update Next Wave Update News Flow Daiichi-Sankyo 25#26Next Wave New project: DS-3939 starts Ph1/2 study DXD-ADC directed TA-MUC1 (DAR: 8) Ph1/2 study in solid tumors is planned to start in FY2023 Q2 Dose Escalation Part DS-3939 (IV, Q3W) Ph1/2 Study Design Locally advanced, metastatic, or unresectable NSCLC, BC, UC, Dose Expansion Part DS-3939 (IV, Q3W) Multiple expansion cohorts targeting various advanced solid tumors OVC, BTC, or PDAC Evaluate safety and preliminary efficacy ■DS-3939 is an ADC developed by Daiichi-Sankyo combining an anti-TA-MUC1 antibody in-licensed from Glycotope GmbH (Berlin, Germany) and Daiichi Sankyo's DXD-ADC technology ■Tumor-associated Mucin 1 (TA-MUC1) is a transmembrane glycoprotein overexpressed in LC, BC, OVC, and other tumor types ■FIH study in solid tumors composed of dose escalation and dose expansion part is planned to start in FY2023 Q2 BC: breast cancer, BTC: biliary tract cancer, DAR: drug-antibody ratio, IV: intravenous, LC: lung cancer, NSCLC: non-small cell lung cancer, OVC: ovarian cancer, PDAC: pancreatic ductal adenocarcinoma, Q3W: every 3 weeks, UC: urothelial cancer 26#27Next Wave New project: DS-1471 starts Ph1 study DS-1471 is a monoclonal antibody targeting CD147 Ph1 study for solid tumors is planned to start in FY2023 H2 Daiichi-Sankyo ITGA ITGB DS-1471 anti-CD147 antibody binding to target CD147 CD44 MCT Suppression of CD147 complex ITGA ITGB CD147 CD44 MCT ↑ Stress response ↑ SMAD ↑ JNK ↑ P38 Cell membrane Cell death ↑ Caspase3 ■CD147 complex is important in survival, such as invasion and metastasis, in cancer tissues; also involved in embryogenesis and wound healing etc., in normal tissue ■Unique MoA by downregulation of CD147 complex leading to cellular stress response and apoptotic cell death ■FIH study composed of dose escalation and dose expansion in solid tumors will start FY2023 H2 FIH: first in human, MoA: mechanism of action 27#28Next Wave Clinical and Regulatory Progress VanflytaⓇ (quizartinib) (FLT3-ITD positive acute myeloid leukemia [AML], 1L) May 2023: Approved in Japan ■■Jul 2023: Approved in US Ezharmia (valemetostat) (relapsed/refractory peripheral T-cell lymphoma [PTCL]) Jun 2023: TLR obtained DS-5670 (COVID-19 mRNA vaccine) ■May 2023: Ph3 study for omicron strain booster vaccination in healthy volunteers 12 years and over ■May 2023: Ph2/3 study for omicron strain booster vaccination in children aged 5 to 11 years. DS-7011 (systemic lupus erythematosus [SLE]) Jul 2023: Ph1b/2 study for SLE patients started DS-2325 (Netherton syndrome) ■May 2023: Granted Rare Pediatric Disease Designation by FDA Daiichi-Sankyo FDA: U.S. Food and Drug Administration, TLR: top line results 28#295DXD-ADCs Update Next Wave update News Flow Daiichi-Sankyo 29#30FY2023 News Flow Planned major publications WCLC (Sep 9-12, 2023) ENHERTU® DESTINY-Lung02: HER2 mutant NSCLC, 2L+, Ph2 • Primary analysis data Dato-DXd TROPION-Lung04: NSCLC w/o AGA, 1L+, Ph1 . Interim data HER3-DXd HERTHENA-Lung01: EGFR mutant NSCLC, 3L, Ph2 •. Primary analysis data DS-7300 (1-DXd) Ph1/2 • SCLC sub-analysis data Regulatory decisions DESTINY-Lung01, 02: HER2 mutant NSCLC, 2L+, Ph2 ENHERTU® • JP: FY2023 Q2 • EU: FY2023 H2 VANFLYTAⓇ QUANTUM-First: AML, 1L, Ph3 • EU: FY2023 H2 Key data readouts ENHERTU® Daiichi-Sankyo As of Jul 2023 DESTINY-Breast06*: HR+ and HER2 low BC, chemo naïve, Ph3 • FY2023 H2 TROPION-Breast01*: HR+ and HER2 low or negative BC, 2/3L, Dato-DXd Ph3 FY2023 H2 DS-5670 COVID-19 mRNA vaccine, original strain, booster vaccination, healthy adults, Ph1/2/3 ⚫ JP: FY2023 Q2 Bold: update from FY2022 Q4 AGA: actionable genomic alterations, AML: acute myeloid leukemia, BC: breast cancer, HR: hormone receptor, NSCLC: non-small cell lung cancer, SCLC: small cell lung cancer, WCLC: World Conference on Lung Cancer Timeline indicated is based on the current forecast and subject to change. *Event-driven study 30 50#31Agenda 1 FY2023 Q1 Financial Results 2 Business Update 3 R&D Update 4 Appendix Daiichi-Sankyo 31#32Major R&D Milestones (5DXd-ADCS 1) Project ENHERTU® As of Jul 2023 BC . . Target Indication [phase, study name] HER2 low, post chemo [Ph3, DESTINY-Breast04] HER2 low, chemo naïve [Ph3, DESTINY-Breast06] HER2+, 1L [Ph3, DESTINY-Breast09] HER2+, Neoadjuvant [Ph3, DESTINY-Breast11] FY2023 FY2024 H1 H2 ⚫ Approved (China) • ⚫ TLR anticipated . ⚫ TLR anticipated ⚫ TLR anticipated . HER2 mutant, 2L • Approval anticipated (JP) [Ph2, DESTINY-Lung01, 02] • Approval anticipated (EU) NSCLC • HER2 mutant, 1L ⚫ TLR anticipated [Ph3, DESTINY-Lung04] Bold: update from FY2022 Q4 BC: breast cancer, HR: hormone receptor, NSCLC: non-small cell lung cancer, TLR: top line results Timeline indicated is based on the current forecast and subject to change Daiichi-Sankyo 32#33Major R&D Milestones (5DXd-ADCS 2) Project Target Indication [phase, study name] NSCLC • 2/3L [Ph3, TROPION-Lung01] Dato-DXd BC • HR+ and HER2 low or negative BC, 2/3L [Ph3, TROPION-Breast01] • TNBC, 1L HER3-DXd NSCLC [Ph3, TROPION-Breast02] • EGFR mutated, 2L [Ph3, HERTHENA-Lung02] DS-7300 (I-DXd) SCLC . 2L [Dose optimization, Ph2] As of Jul 2023 FY2023 FY2024 H1 H2 • TLR obtained • TLR anticipated TLR anticipated TLR anticipated . ⚫ TLR anticipated Daiichi-Sankyo Bold: update from FY2022 Q4 BC: breast cancer, HR: hormone receptor, NSCLC: non-small cell lung cancer, SCLC: small cell lung cancer, TLR: top line results, TNBC: triple-negative breast cancer Timeline indicated is based on the current forecast and subject to change 33#34Major R&D Milestones (Next Wave) Project VANFLYTAⓇ EZHARMIA® DS-1103 DS-3939 Target Indication [phase, study name] • AML, 1L [Ph3, QUANTUM-First] Daiichi-Sankyo As of Jul 2023 FY2023 FY2024 H1 H2 • Approved (JP/US) • Approval anticipated (EU) ⚫r/r PTCL [Registrational Ph2, VALENTINE-PTCL01] • HER2 expressing or mutant solid tumors, HER2 low BC [Ph1] Solid tumors [Ph1/2] • TLR obtained • Study started Study start planned DS-1471 · Solid tumors [Ph1] DS-7011 DS-5670 • ⚫ Systemic lupus erythematosus [Ph1b/2] • COVID-19 mRNA vaccine (mutant strain), booster vaccination [Ph3] • ⚫ Study started • Study started • Study start planned Bold: update from FY2022 Q4 • COVID-19 mRNA vaccine (original strain), booster vaccination [Ph1/2/3] • Approval anticipated (JP) AML: acute myeloid leukemia, BC: breast cancer, PTCL: peripheral T cell lymphoma, r/r: relapsed/refractory, TLR: top line results Timeline indicated is based on the current forecast and subject to change 34#35Major R&D Pipeline: 5DXd-ADCS As of Jul 2023 Daiichi-Sankyo (US/EU/Asia) HER2+ BC 2L+/1L DESTINY-Breast07 (US/EU/Asia) HER2 low BC Chemo naïve/ post chemo DESTINY-Breast08 (JP/US/EU/Asia) HER2+ GC combo, 2L+/1L DESTINY-Gastric03 (durvalumab combo) 1L (US/EU/Asia) HER2+ NSCLC DESTINY-Lung03 (US/EU) BC, bladder (nivolumab combo) (US/EU) BC, NSCLC (pembrolizumab combo) (US/EU/Asia) solid tumors (AZD5305 combo) PETRA DS-7300 (JP/US) ESCC, CRPC, squamous NSCLC, SCLC, etc. Phase 1 (JP/US) solid tumors TROPION-PanTumor01 (CN) NSCLC, TNBC TROPION-PanTumor02 (JP/US/EU/Asia) NSCLC (w/o AGA, pembrolizumab combo) TROPION-Lung02 (JP/US/EU) NSCLC (w/o AGA, durvalumab, AZD2936 and MEDI5752 combo) TROPION-Lung04 (JP/US/EU/Asia) solid tumors (AZD5305 combo) PETRA (JP/US/EU/Asia) NSCLC (US/EU/Asia) TNBC (durvalumab combo) BEGONIA (CN) HER2+ GC 3L DESTINY-Gastric06 (CN) HER2 mutant NSCLC 2L+ DESTINY-Lung05 (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 (JP/US) EGFR mutated NSCLC (osimertinib combo) (JP/US) HER3+ BC (JP/US/EU/Asia) HER2 mutant tumor DESTINY-PanTumor01 (US/EU/Asia) HER2 expressing tumor DESTINY-PanTumor02 Phase 2 (JP/US/EU/Asia) solid tumors TROPION-PanTumor03 (JP/US/EU/Asia) NSCLC (w/ AGA) TROPION-Lung05 (US/EU/Asia) TNBC (durvalumab combo) BEGONIA (JP/US/EU/Asia) EGFR mutated NSCLC (osimertinib combo) 2L ORCHARD (US/EU/Asia) resectable early-stage NSCLC (durvalumab combo) neoadjuvant NeoCOAST-2 (JP/US/EU/Asia) EGFR mutated NSCLC 3L HERTHENA-Lung01 DS-7300 (JP/US/EU/Asia) ES-SCLC Phase 3 (JP/US/EU/Asia) HER2+ BC adjuvant*1 DESTINY-Breast05 (UP/US/EU/Asia) HER2 low BC chemo naïve DESTINY-Breast06 (JP/US/EU/Asia) HER2+ BC 1L DESTINY-Breast09 (JP/US/EU/Asia) HER2+ BC neoadjuvant DESTINY-Breast11 (US/EU/Asia) HER2 low BC, HER2 IHC 0 BC, 2/3L DESTINY-Breast15 (JP/EU/Asia) HER2+ GC 2L DESTINY-Gastric04 (JP/US/EU/Asia) NSCLC (w/ HER2 exon 19 or exon 20 mutation) 1L DESTINY-Lung04 (JP/US/EU/Asia) NSCLC 2/3L TROPION-Lung01 Filed (JP/EU) HER2 mutant NSCLC 2L+ DESTINY-Lung01/Lung02 DS-6000 (JP/US) Renal cell carcinoma, ovarian cancer ENHERTUⓇ Dato-DXd HER3-DXd DS-7300 DS-6000 (JP/US/EU/Asia) non-squamous NSCLC (w/o AGA, pembrolizumab combo) 1L TROPION-Lung07 (JP/US/EU/Asia) NSCLC (w/o AGA, pembrolizumab combo) 1L TROPION-Lung08 (JP/US/EU/Asia) BC*2 2/3L TROPION-Breast01 * 1 * 2 Project in oncology that is planned to be submitted for approval in some countries/regions based on the results of phase 2 trials Breakthrough Designation (US) Orphan drug designation (designated in at least one country/region among JP, US and EU) Adjuvant therapy for HER2 positive breast cancer patients with residual invasive disease following neoadjuvant therapy HR+, HER2 low or negative BC *3 Adjuvant therapy for TNBC patients with residual invasive disease following neoadjuvant therapy AGA: actionable genomic alterations, BC: breast cancer, CRC: colorectal cancer, CRPC: castration-resistant prostate cancer, ESCC: esophageal squamous cell carcinoma, ES-SCLC: extensive stage-small cell lung cancer, GC: gastric cancer, NSCLC: non-small cell lung cancer, SCLC: small cell lung cancer, TNBC: triple negative breast cancer (JP/US/EU/Asia) TNBC 1L TROPION-Breast02 (JP/US/EU/Asia) TNBC (mono or durvalumab combo) adjuvant*3 TROPION-Breast03 (JP/US/EU/Asia) EGFR mutated NSCLC 2L HERTHENA-Lung02 35#36Major R&D Pipeline: Next Wave DS-1055 (JP/US) Anti-GARP antibody Solid tumors DS-1594 (US) Menin-MLL binding inhibitor AML, ALL DS-9606 (US/EU) Target undisclosed ADC Solid tumors DS-1103 Anti-SIRPA antibody Phase 1 HER2 expressing or mutant advanced metastatic solid tumors, HER2 low BC (ENHERTUⓇ combo) DS-3939 Anti-TA-MUC1 ADC Solid tumors (in prep.) DS-1471 Anti-CD147 antibody Solid tumors (in prep.) DS-7011 (US) Anti-TLR7 antibody Systemic lupus erythematosus DS-2325 (US) KLK5 inhibitor Netherton syndrome +00 Phase 2 Valemetostat (DS-3201)(JP/US/EU/Asia) EZH1/2 inhibitor PTCL Valemetostat (DS-3201) (EU) EZH1/2 inhibitor BCL DS-1001 (JP) Mutant IDH1 inhibitor Glioma DS-1211 (US/EU) TNAP inhibitor Pseudoxanthoma elasticum As of Jul 2023 Phase 3 Filed Pexidartinib (JP/Asia) Quizartinib (EU) CSF-1/KIT/FLT3 inhibitor Tenosynovial giant cell tumor FLT3 inhibitor AML 1L Esaxerenone (JP) MR blocker Diabetic nephropathy VN-0102/JVC-001 (JP) Measles mumps rubella combined vaccine DS-5670 (JP) COVID-19 mRNA vaccine (original strain), COVID-19 (primary vaccination, 12 to 17 aged children) Mirogabalin (CN) a28 ligands Diabetic peripheral neuropathic pain DS-5670 (JP) COVID-19 mRNA vaccine (original strain) COVID-19 (booster vaccination) DS-5670 (JP) COVID-19 mRNA vaccine (mutant strain), COVID-19 (primary vaccination, 5 to 11 aged children) (in prep.) VN-0200 (JP) RS virus vaccine RS virus infection DS-5670 (JP) COVID-19 mRNA vaccine (mutant strain) COVID-19 (booster vaccination, 12 years old and over) DS-5670 (JP) COVID-19 mRNA vaccine (mutant strain), COVID-19 (booster vaccination, 5 to 11 aged children) Oncology Specialty medicine Vaccine Project in oncology that is planned to be submitted for approval in some countries/regions based on the results of phase 2 trials " SAKIGAKE Designation (JP) Fast Track Designation (US) Orphan drug designation (designated in at least one country/region among JP, US and EU) Breakthrough Designation (US) Rare Pediatric Disease Designation (US) ALL: acute lymphoblastic leukemia, AML: acute myeloid leukemia, BCL: B cell lymphoma, LBCL: large B cell lymphoma, PTCL: peripheral T-cell lymphoma Daiichi-Sankyo 36#37Contact address regarding this material Daiichi Sankyo Co., Ltd. Corporate Communications Department TEL: +81-3-6225-1125 Email: [email protected]