Slides
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December 16th, 2025 Science & Technology Day 2025 DAIICHI SANKYO CO., LTD.
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2 Management strategies and plans, financial forecasts, future projections and policies, and R&D information that Daiichi Sanky o discloses in this material are all classified as Daiichi Sankyo’s future prospects. These forward-looking statements were determined by Daii chi Sankyo based on information obtained as of today with certain assumptions, premises and future forecasts, and thus, there are various i nherent risks as well as uncertainties involved. As such, please note that actual results of Daiichi Sankyo may diverge materially from Da iichi 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 age ncy worldwide as a treatment for indications under investigation. Efficacy and safety have not been established in areas under in vestigation. 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 guar antee the absolute accuracy, appropriateness, completeness and feasibility, etc. of the information described in this material. Furthermore, an y information regarding companies, organizations or any other matters outside the Daiichi Sankyo Group that is described within this materi al 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 thereo f. The information described in this material may be changed hereafter without notice. Accordingly, this material or the inform ation 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 Sta tes, Japan or elsewhere. This material disclosed here is for reference purposes only. Final investment decisions should be made at your own discretio n. Daiichi Sankyo assumes no responsibility for any damages resulting from the use of this material or its content, including witho ut limitation damages related to the use of erroneous information. Forward-Looking Statements
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Science & Technology Day 2025 Presenters 3 Ken Takeshita Head of Global R&D Ken Keller Head of Global Oncology Business Hiroyuki Okuzawa President and CEO Hiroto Kashiwase Head of Global Technology Yuki Abe Head of Global Research
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Agenda Welcome Clinical Development Oncology Business Technology Research Q&A 1 2 3 4 5 6 4
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Agenda Welcome Clinical Development Oncology Business Technology Research Q&A 1 2 3 4 5 6 5
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Daiichi Sankyo Won Three World ADC Awards in 2025 6 TROP2 Directed ADC recognized for “Best ADC Clinical Impact” HER2 Directed ADC recognized for “Best ADC Clinical Publication” Daiichi Sankyo’s DXd ADC Technology recognized for “Best ADC Platform Technology” 6
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Agenda Welcome Clinical Development Oncology Business Technology Research Q&A 1 2 3 4 5 6 7
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• DXd ADCs … More than ENHERTU® Updates from DXd ADC portfolio • New Concept ADCs mPBD, STING agonist payloads & others • New Non-ADC Oncology Pipeline Targeted Protein Degraders, Novel Immune- Oncology Targets • Scientifically Rational Combinations Unlocking the potential of DXd ADCs Looking Towards the Horizon … Future of Daiichi Sankyo’s ADC Technology 8
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I-DXd & R-DXd Multiple Accomplishments & Recognitions Continue to Demonstrate the Value of DXd ADCs 9 As of CY2025 … • BTDs for I-DXd in SCLC, and R-DXd in PROC, resulting in a total of 13 BTDs for DXd ADC portfolio • 35+ Countries and Regions Regulatory Approved • 1 Accelerated Approval for TROPION-Lung05 supported by TROPION-Lung01 based on BTD DATROWAY® ENHERTU® BTD: Breakthrough Therapy Designation; mBC: metastatic breast cancer; PROC: Platinum-resistant ovarian cancer; SCLC: small cell lung cancer; SQ: squamous • 15 new Regulatory Approvals across 15 countries and regions • 94 extension Approvals across 45 countries and regions • 85 Regulatory Submissions • Recent BTD in 1L HER2 positive mBC, for a total of 9 BTDs for ENHERTU®
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Multiple Accomplishments & Recognitions Continue to Demonstrate the Value of DXd ADCs 10 Since 2019, Daiichi Sankyo has received 15 awards & recognitions for our world-class science. Most recently, Daiichi Sankyo was honored to receive 3 World ADC Awards for ENHERTU ®** and DATROWAY®*** as well as for “Best ADC Platform Technology”. In the past two years, 22 articles about our DXd ADC technology have been featured in prestigious journals* including The New England Journal of Medicine & Nature Medicine ADC: antibody-drug conjugate * Journal of Clinical Oncology, Nature Medicine, The New England Journal of Medicine, The Lancet Oncology ** Best ADC Clinical Publication Award for DESTINY-PanTumor02 publicationin 2024 *** Best ADC Clinical Impact Award for studies including TROPION-Breast01, TROPION-Breast02, TROPION-Lung05
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Advancing ENHERTU® into Early Breast Cancer and DATROWAY® as the New 1L SOC in TNBC 11 HR+ 65% TNBC 15% HER2+ 20% HER2 low 60% HER2 ultralow 25% HER2 null 15% Neoadjuvant 1L 2L+ DESTINY-Breast11 DESTINY-Breast05 Residual Disease DESTINY -Breast06 DESTINY-Breast09 Evaluating potentialTROPION -Breast02 CPS<10 or IO ineligible TROPION-Breast03 Residual Disease DESTINY-Breast04 HER2 low DESTINY-Breast01/02/03 TROPION-Breast04 TROPION -Breast05 CPS≥10 Adjuvant DESTINY -Breast04 Evaluating Potential or Preparing Study Plans Neoadjuvant ETAdjuvant post 1-2L ET post 1-2L chemotherapy Evaluating potential TROPION-Breast01 ENHERTU® DATROWAY® HER3-DXd • Pivotal studies only, not exhaustive • Box size does not reflect the patient population • Box indicates current potential target segment CPS: combined positive score, ET: endocrine therapy, HR: hormone receptor, IO: immuno-oncology, TNBC: triple-negative breast cancer Early Pipeline HERTHENA-Breast04 ENHERTU® DATROWAY®: Launched : Completed Data Readout DATROWAY® : On-going : BEGONIA data supports TROPION-Breast03, TROPION-Breast04, TROPION-Breast05DATROWAY®
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ESMO 2025 DESTINY-Breast11 (Neoadjuvant) 12 For the ITT population, treatment effects were estimated by the difference in pCRwith 95% CIs and P-values based on the stratified Miettinen and Nurminen’smethod, with strata weighting by sample size (ie Mantel–Haenszel weights) *By blinded central review; †pCR responders were defined as patients who only received randomized study treatment (at least one dose) and had pCR; ‡two-sided P-value crossed the 0.03 prespecified boundary. Neoadjuvant T-DXd-THP demonstrated a statistically significant and clinically meaningful improvement in pCR vs ddAC-THP in patients with high-risk HER2+ eBC. Improvement was observed in both the HR-positive and HR-negative subgroups DESTINY-Breast05 (Post Neoadjuvant) Primary endpoint: IDFSa Efficacy stopping boundary, P = 0.0183 aIDFS is defined as the time from randomization until the date of first occurrence of one of the following events: recurrence of ipsilateral invasive breast tumor, recurrence of ipsilateral locoregional invasive breast cancer, contralateral invasive breast cancer, a distant disease recurrence, or death from any cause. bTwo-sided P value from stratified log-rank test. Hazard ratio and 95% CI from stratified Cox proportional hazards model with stratification factor of operative status at disease presentation. 53% reduction in the risk of invasive disease recurrence or death for T- DXd compared with T-DM1 in patients with HER2+ eBC CI: confidence interval, eBC: early breast cancer, ESMO: European Society for Medical Oncology. HR: hormone receptor, HR: hazard ratio, IDFS: invasive disease-free survival, ITT: intention-to-treat, pCR: pathological complete response, T-DM1, trastuzumab emtansine, T-DXd, trastuzumab deruxtecan(ENHERTU®), THP: Taxane (paclitaxel or docetaxel) + trastuzumab +pertuzumab Primary endpoint: pCR (ypT0/is ypN0) Go Earlier in HER2+eBC: Positive Trials, with Potential Cure of eBC at a High Risk of Recurrence
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13 DATROWAY® is the First and Only TROP2 directed ADC Showing Statistically Significant & Clinically Meaningful OS Results in 1L mTNBC In TROPION-Breast02, DATROWAY® demonstrated a statistically significant and clinically meaningful improvement of ~5 months in both mOS and mPFS vs chemotherapy (OS HR: 0.79, mOS: 23.7 vs. 18.7 mo) • Statistically significant OS despite use of subsequent ADCs in the control arm • DATROWAY® achieved ORR two-fold higher than chemotherapy (62% vs. 29.3% for chemotherapy) , with durable responses lasting >1 year. Durable responses are important in TNBC where responses with chemotherapy are short-lived TROPION-Breast02 enrolled a population representing ~70% of patients with 1L mTNBC, and included those often excluded from clinical trials with the poorest prognosis (e.g. DFI < 6 months) Despite more than double the duration of treatment (8.5 vs 4.1 mo), rates of Grade≥3 and serious TRAEs were similar, and discontinuations were lower, with DATROWAY® vs chemotherapy. AESIs (e.g. stomatitis, ILD) were primarily Grade 1–2 and manageable DATROWAY® has more convenient administration schedule (Q3W) DATROWAY® leverages the clinically-validated DXd technology with a tumor-selective cleavable linker that is specifically designed to reduce systemic exposure to the payload TROPION-Breast02 results support DATROWAY® as a potential new 1L standard of care for patients with metastatic TNBC for whom immunotherapy is not an option Three additional studies of DATROWAY® are ongoing with PD-L1 agents in the TNBC setting including neoadjuvant, adjuvant and metastatic 1L ESMO 2025 TROPION-Breast02 (1L mTNBC) Progression-Free Survival by BICR Overall Survival AESI: adverse event of special interest, BICR: blinded independent central review, CI: confidence interval, DFI: disease- free interval, ESMO: European Society for Medical Oncology, HR: hazard ratio, ICC: Investigator’s choice of chemotherapy, ILD: interstitial lung disease,IO: immune oncology, mo: months, mOS: median overall survival, mPFS: median progression-free survival, OS: overall survival, ORR: Objective Response Rate, PFS: progression-free survival, Q3W: once every 3 weeks, mTNBC: metastatic triple-negative breast cancer, TRAE: treatment-related adverse event
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DATROWAY®+ durvalumab demonstrated promising efficacy in BEGONIA, supporting the combination in TNBC 14 Confirmed ORR was 79.0% (49/62; 95% CI, 66.8–88.3) with 8 CR and 41 PR Arm 7 ( 87.1% had PD-L1 low tumors) Arm 8 (PD- L1 high) AEs were primarily low grade (Grade 1-2); and the most common AEs were stomatitis, nausea, and alopecia Across both arms, rates of adjudicated drug-related ILD were low, with no grade ≥3 events median DOR: 17.6 months and median PFS: 14 months median DOR: median PFS were immature Three Ph3 studies (TROPION-Breast03, TROPION-Breast04, TROPION-Breast05) are underway with DATROWAY®+durvalumab across TNBC settings ESMO 2025 CI: confidence interval, CR: complete response, DOR: duration of response, ESMO: European Society for Medical Oncology, GI: gastrointestinal, ILD: interstitial lung disease, ORR: overall response rate, PFS: progression-free survival, PR: partial response, TNBC: triple-negative breast cancer Confirmed ORR was 81.8% (27/33; 95% CI, 64.5–93.0) with 2 CR and 25 PR
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Establish and Expand DXd ADCs to Address the Broad Spectrum of Lung Cancer 15 NSCLC ~84% SCLC ~13% Stage I - III 1L 2L+ ADC: antibody-drug conjugate, AGA: actionable genomic alteration, IHC: immunohistochemistry, NSQ: non- squamous, NSCLC: non-small cell lung cancer, SCLC: small cell lung cancer, SQ: squamous EGFRm Others AGA NSQ SQ IDeate-Lung02 IDeate-Lung01 (Ph2) TROPION-Lung14 PD-L1 > 50% I-DXd Evaluating Potential or Preparing Study Plans TROPION-Lung15 PD-L1 < 50% • Pivotal studies and major Ph2 only, not exhaustive • Box size does not reflect the patient population • Box indicates current potential target segment TROPION-Lung07 TROPION-Lung08 TROPION-Lung10 AVANZAR TROPION-Lung05 (Ph2) TROPION -Lung12 Adjuvant HER2m DESTINY-Lung04 TROPION-Lung17 TROP2 NMR+ DESTINY-Lung01/02 DESTINY-PanTumor02/ Lung01 HER2+ (IHC 3+) DESTINY-Lung06 HER2 overexpression ENHERTU® DATROWAY® : Launched, : Completed Data Readout, ENHERTU® I-DXdDATROWAY® : On-going, DATROWAY® : Planning
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Daiichi Sankyo/US Merck* Partnership Includes Two Complementary Assets with Activity in SCLC, and Combination Data are Eagerly Waited 16BICR: blinded independent central review, CI: confidence interval, cORR: confirmed objective response rate, CR: complete response, DCR: disease control rate, ES-SCLC: extensive-stage small cell lung cancer, LOT: line of treatment, NEC: neuroendocrine cancer, ORR: objective response rate, PR: partial response, QxW: every x weeks, RECIST: Response Evaluation Criteria in Solid Tumours, SCLC: small cell lung cancer Gocatamig DLL3-targeting T-cell engager cORR, 44% (95% CI, 32-56) in all cohorts (N=73) I-DXd 12 mg/kg demonstrated promising antitumor activity in ES-SCLC Data cutoff: March 3, 2025 Data cutoff: February 28, 2025. aAmong 68 participants who received any amount of study treatment and had at least one postbaseline scan. * Merck & Co., Inc., Rahway, NJ, USA aAssessed by BICR per RECIST 1.1. bBy BICR.
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How a Novel Computational Predictive Biomarker Gives DATROWAY® an Advantage in 1L NSCLC: TROP2 NMR by Novel Pathology Approach, QCS 17 - IHC with TROP2 Assay 1 Whole Slide Imaging Patient Biomarker Status Determination Automated Image Analysis (QCS) Calculates TROP2 NMR for every tumor cell Cytosol Membrane Nucleus Membrane and cytoplasm optical density (OD) Measures OD in each tumor cellDifferentiates tumor from non-tumor Membrane OD Membrane OD + Cytoplasm OD Lower NMR → higher cytoplasm proportion ≥75% of tumor cells with TROP2 NMR ≤0.56+ <75% of tumor cells with TROP2 NMR ≤0.56 TROP2 Tumor membrane expression using conventional IHC and pathology visual scoring does not enrich for response in NSCLC TROP2 NMR as measured by QCS reflects the expression of TROP2 in the membrane relative to total TROP2 (membrane and cytoplasm) IHC: immunohistochemistry, NMR: normalized membrane ratio, NSCLC: non-small cell lung cancer, OD: optical density, QCS: quantitative continuous scoring, WCLC: World Conference on Lung Cancer 2 3 4 WCLC 2024
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TROP2 NMR Positivity was Predictive for Longer PFS with DATROWAY® in TROPION-Lung01 18 WCLC 2024 TROP2 NMR measured by QCS predicted outcomes in an exploratory analysis in the TROPION-Lung01 trial evaluating DATROWAY ® as monotherapy in the 2L+ setting 1 CI: confidence interval, HR: hazard ratio, NMR: normalized membrane ratio, NSCLC: non-small lung cancer, ORR: objective response rate, PFS: progression-free survival, QCS: quantitative continuous scoring, WCLC: World Conference on Lung Cancer 1. Garassino MC et al. J Thorac Oncol. 2024;19:S2–S3. TROP2 NMR+ TROP2 NMR- NMR+ NMR- NMR+ NMR-
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Exploratory Analysis per TROP2 NMR in 1L NSCLC 19 TROPION-Lung02 : PFS by TROP2 QCS-NMR, 1L Biomarker Evaluable Population ASCO 2025 Data cutoff: April 29, 2024. ASCO: American Society of Clinical Oncology , BEP: biomarker evaluable population, CI: confidence interval, HR: hazard ratio, CT: chemotherapy, mo: months, NMR: normalized membrane ratio, ORR: objective response rate, OS: overall survival, PFS: progression-free survival Exploratory TROP2 NMR testing showed a trend towards prolonged PFS and OS in biomarker positive patients treated with DATROWAY® in combination with PD-1 agents (doublet) or with CT+ PD-1 agents (triplet) 80 Progression-free survival (%) 100 60 40 20 0 Time (months) 0 10 20 30 No. at risk: TROP2 NMRｰ TROP2 NMR+ 37 22 8 0 39 15 4 1 Median PFS (95％ CI) TROP2 NMR+ (n＝37) 12.0 mo (8.2－26.2) TROP2 NMR- (n＝39) 8.1 mo (4.2－13.2) HR ＝ 0.62 (0.35－1.10) BEP (n＝76) Doublet (n＝32) Triplet (n＝44) BEP (n＝76) Doublet (n＝32) Triplet (n＝44) 0 0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 OS HR PFS favors TROP2 NMR+
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DATROWAY®: 5 Combination Studies with IO in the 1L NSCLC Ongoing, Some applied TROP2 NMR Biomaker e.g., AVANZAR 20 DATROWAY® + Immune checkpoint inhibitors DATROWAY® + tyrosine kinase inhibitors pembrolizumab TROPION-Lung07 NSQ w/o AGA PD-L1 <50%, 1L TROPION-Lung08* w/o AGA PD-L1 ≥50%. 1L durvalumab osimertinib Ph2 Ph3 TROPION-Lung02 w/o AGA AGA: actionable genomic alteration, EGFRm: EGFR mutated, IO: immuno oncology, NMR: normalized membrane ratio,NSQ: non-squamous , NSCLC: non-small cell lung cancer rilvegostomig TROPION-Lung12 stage1 high risk, adjuvant TROPION-Lung10 NSQ w/o AGA PD-L1 ≥50%, 1L TROPION-Lung14 EGFRm, 1L TROPION-Lung15 EGFRm, 2L+ AVANZAR* w/o AGA, 1L * Due to the protocol revision, the inclusion criteria are limited to NSQ NSCLC TROPION-Lung04 w/o AGA NeoCOAST-2 early stage, neoadjuvant ORCHARD EGFRm, 2L Ph1 TROP2 NMR applied prospectively
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Expanding Daiichi Sankyo ADCs within Women’s Cancers to Address Broad Spectrum of Gynecologic Cancers 21 Ovarian Cancer Advanced (III-IV) Recurrent DiseaseEarly (I-II) Platinum-sensitive Platinum-resistant1L induction 1L Maintenance Endometrial Cancer Advanced / RecurrentEarly stage 1L 2L+Adjuvant HRD 50% HRP 50% BRCAm 15% BRCA wt 85% *ENHERTU® tumor agnostic approval (HER2 IHC 3+) in 2L+ setting. NCCN Ovarian Cancer Guidelines (Jan 2025) update Category 2B recommendation of ENHERTU® in HER2+ (IHC 3+) PSOC. NCCN Endometrial Cancer Guidelines (2025) includes a Category 2B recommendation for ENHERTU® in HER2+ (IHC 2+/3+) endometrial cancer in the 2L+ setting. dMMR 25% pMM R 75% p53 WT 60% p53m ~40% DESTINY- PanTumor02 HER2+ (IHC 3+)* REJOICE- Ovarian 01 DESTINY-Endometrial01 HER2+ (IHC 3+/2+) DESTINY-PanTumor02 HER2+ (IHC 3+)* DESTINY- Endometrial02 HER2+ (IHC 3+/2+) Daiichi Sankyo Registrational Studies Across Gynecological Cancers DESTINY- Ovarian01 HER2+ (IHC 3+/2+/1+) • Pivotal studies only, not exhaustive. • Box size does not reflect the patient population • Box indicates current potential target segment Exploring 7 Clinical Stage Assets in GYN R-DXd ADC: antibody-drug conjugate, dMMR: deficient mismatch repair, HRD: homologous recombination deficiency, HRP: homologous recombination proficient, IHC: immunohistochemistry, NCCN: National Comprehensive Cancer Network, pMMR: mismatch repair proficient, PSOC: platinum-sensitive ovarian cancer, WT: wild type Indicates DXd ADC technology Compound Target Payload ENHERTU® HER2 TOPO1 DATROWAY® TROP2 TOPO1 HER3-DXd HER3 TOPO1 I-DXd B7-H3 TOPO1 R-DXd CDH6 TOPO1 DS-3939 TA-MUC1 TOPO1 DS-9606 CLDN6 mPBD ENHERTU® : Launched, : On-goingENHERTU®
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R-DXd Confirmed Clinical Meaningful Responses in Ph2 Part REJOICE-Ovarian01 Ph2/3 22 Clinically meaningful tumor responses were seen irrespective of dosea Data cutoff: February 26, 2025. The median follow-up for 4.8-mg/kg, 5.6-mg/kg, and 6.4-mg/kg cohorts was 5.6 months (95% CI, 4.7–6.3), 5.6 months (95% CI, 4.6–5.8), and 5.2 months (95% CI, 4.9–5.8), respectively. aAntitumor response assessed by BICR per RECIST 1.1. Only patients with measurable disease at baseline and≥1 post-baseline tumor scan, both by BICR, were included in the waterfall plot (n=100). Six patients (R-DXd 4.8 mg/kg [n=5]; 6.4 mg/kg [n=1]) did not have measurable disease at baseline and one patient (R-DXd 5.6 mg/kg) had no adequate post-baseline tumor assessment. bDCR was defined as percentage of patients with BOR of CR, PR, or SD (per RECIST 1.1). R-DXd Granted Breakthrough Therapy Designation by U.S. FDA for Patients with CDH6 Expressing Platinum- Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancers Previously Treated with Bevacizumab – September 2025 ESMO 2025 BICR: blinded independent central review, BOR: best overall response, CI: confidence interval, CR: complete response, DCR: disease control rate, ESMO: European Society for Medical Oncology, ORR: objective response rate, PR: partial response, RECIST: Response Evaluation Criteria in Solid Tumours, SD: stable disease
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Expanding Daiichi Sankyo Assets within Genitourinary Cancers to Address a Broad Spectrum of Unmet Needs 23 Prostate Cancer Bladder Cancer *ENHERTU® tumor agnostic approval (HER2 IHC 3+) in 2L+ setting. NCCN Bladder Cancer Guidelines (Oct 2025) Category 2A recommendation Daiichi Sankyo Registrational Studies Across Genitourinary Cancers Compound Target ENHERTU® HER2 DXd ADC DATROWAY® TROP2 DXd ADC HER3-DXd HER3 HER2 DXd ADC I-DXd B7-H3 DXd ADC DS-3939 TA-MUC1 DXd ADC EZHARMIA® EZH1/2 inhibitor DS-2243 HLA-A*02 / NY-ESO Bispecific TCE DS9051 Targeted Protein Degradation Molecule ADC: antibody-drug conjugate, HSPC: hormone-sensitive prostate cancer, IHC: immunohistochemistry, LA/mUC: locally advanced/ metastatic urothelial cancer mCRPC: metastatic castration-resistant prostate cancer , MIBC: muscle invasive bladder cancer, NCCN: National Comprehensive Cancer Network, TCE: T-cell engager Exploring 8 Clinical Stage Assets in GU Tumors PSMA- ~15% PSMA+ ~85% Chemo-Naïve mCRPC NHA-Naïve Post-NHA Post-Chemo mCRPC • Pivotal studies only, not exhaustive. • Box size does not reflect the patient population • Box indicates current potential target segmentI-DXd IDeate-Prostate01 LA / mUC 1L 2L(+) MIBC Neoadj. Adj. Cis-eligible ~50% Cis- ineligible ~50% TROPION- Urothelial 03 DESTINY- PanTumor 02 HER2+ (IHC 3+)* Carbo eligible ~35% Pt-ineli. ~15% mHSPC Evaluating Potential or Preparing Study Plans Evaluating Potential or Preparing Study Plans ENHERTU® : Launched, : On-goingDATROWAY®
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• DXd ADCs … More than ENHERTU® Updates from DXd ADC portfolio • New Concept ADCs mPBD, STING agonist payloads & others • New Non-ADC Oncology Pipeline Targeted Protein Degraders, Novel Immune- Oncology Targets • Scientifically Rational Combinations Unlocking the potential of DXd ADCs Looking Towards the Horizon … Future of Daiichi Sankyo’s ADC Technology 24
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The Evolution of our ADC Technologies Will Continue 25 Payload Module Cytotoxic payloads • DXd, ｍPBD Other new payloads to combat refractory/resistant tumors • IO payloads • Novel payloads Antibody Module Unique binders targeting disease specific proteins and glycans Fc engineering Novel technologies to increase specificity Linker Module DAR control Site specificity Novel conjugation Our Proprietary Technologies • Tumor specific glycoprotein with high expression in tumors DS-3939 (TA-MUC1) • The First DXd ADC targeting hematopoietic tumors DS3790 (CD37) DXd ADCs with New mAb Targets Different Payload from DXd ADC ADC: antibody-drug conjugate, DAR: drug-antibody ratio, IO: immuno-oncology, mAb: monoclonal antibody,mPBD: modified pyrrolobenzodiazepine ADCs are modular, and interchanging the modules can create new drugs • Featuring tissue selectivity New ADC1 • Featuring optimized retention within cells to increase efficacy New ADC2 New DXd ADCs with engineered mAb or Payload-Linker • Featuring stability and selectivity DS-9606 (mPBD ADC) • Optimized STING agonist payload and Fc technology to reduce irrelevant immune activation DS3610 (STING agonist ADC) • Novel payload with distinct mechanism of action New ADC3
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• DXd ADCs … More than ENHERTU® Updates from DXd ADC portfolio • New Concept ADCs mPBD, STING agonist payloads & others • New Non-ADC Oncology Pipeline Targeted Protein Degraders, Novel Immune- Oncology Targets • Scientifically Rational Combinations Unlocking the potential of DXd ADCs Looking Towards the Horizon … Future of Daiichi Sankyo’s ADC Technology 26
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Advancing New Non-ADC Oncology Pipeline in Global Clinical Development 27 Modality Generic Name/Code Name Target Representative Target Indications Pre- Clinical Ph1 Ph1/2 Ph2 Status T-cell engager Gocatamig DLL3 SCLC FPD in Dec 2020 DS-2243 NY-ESO/HLA-A*02 NSCLC, UC, Sarcoma FPD in Mar 2025 Antibody DS-1103 anti-SIRPα Solid tumors FPD in Jun 2023 Small or mid- size molecules DS5361 Not Disclosed Solid tumors FPD in Oct 2025 DS9051 Not Disclosed CRPC FPD in Nov 2025 BC: breast cancer, CRPC: castration-resistant prostate cancer, DLL3: delta-like ligand 3, FPD: First patient dose, NSCLC: non small cell lung cancer, SCLC: small cell lung cancer, UC: urothelial cancer Timeline indicates the most advanced stage of each asset, and that status may not apply to all tumors listed in the “target tumor” column
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Unique Immune-Oncology Drugs 28 T cell Tumor cellsT cell expansion HLA-A*02/NY-ESO NY-ESO protein (NY-ESO-1 & LAGE-1) ProteasomePeptides DS-2243a (HLA-A*02/NY-ESO) HLA-A*02 /NY-ESO Cytokines Perforins Granzymes T cell receptor like antibody T cell engager targeting HLA-A*02/NY-ESO Modality: Bispecific Antibody Novel IO agent which enhance tumor immuno- genicity Modality: small molecule Frameshift mutation NMD CD4+ T-cell mRNA degradation Frameshift mRNA Premature termination codon Neo-antigens NMD inhibitor Protein with frameshift tail Antigen presenting cell CD8+ T-cell Tumor- infiltrating CD8+ T-cell Tumor cell DNA Lymph node DS-2243 DS5361 IO: immuno-oncology,NMD: nonsense-mediated mRNA decay
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The New Modality to Fight against Cancer- Targeted Protein Degrader 29 E3 ligase* is recruited to the targeted protein by the TPD molecule Ubiquitin** is transferred to the targeted proteinUbiquitinated target is degraded by proteasome CRPC: castration-resistant prostate cancer, FIH: first-in-human, TPD: targeted protein degradation *E3 ligase: enzyme which facilitates the transfer of ubiquitin from E2 ubiquitin-conjugating enzymeto targeted proteins **Ubiquitin: protein which is bound to other proteins and functions in various ways such as a marker for degradation Targeted protein TPD molecule Ligand Linker E3 ligase E3 binding Proteasome Targeted protein degradation is an approach to eliminate disease-causing proteins by the endogenous ubiquitin- proteasome system DS9051 is the first Daiichi Sankyo original targeted protein degrader FIH study started on Nov 2025 in solid tumors including CRPC Targeted Protein Degrader Modality: Mid-size Molecule DS9051
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• DXd ADCs … More than ENHERTU® Updates from DXd ADC portfolio • New Concept ADCs mPBD, STING agonist payloads & others • New Non-ADC Oncology Pipeline Targeted Protein Degraders, Novel Immune- Oncology Targets • Scientifically Rational Combinations Unlocking the potential of DXd ADCs Looking Towards the Horizon … Future of Daiichi Sankyo’s ADC Technology 30
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Addition of durable effect Tumor cell death APC activation against tumor antigens Tumor killing by Teff cells DXd ADCs IO combo agent The potential to promote ADC engagement and/or potentiate synthetic lethality Durable effect by immune memory DXd ADCs Increased antigen Increased payload within cells Complementary signal transduction Combination agent ADC: antibody-drug conjugate, APC: antigen-presenting cell, IO: immuno-oncology Combination Therapy - Unlocking the Potential of DXd ADCs 31 Combination agents that have IO mechanism to add the durable effect induced by the immune system Enhancement of ADC effect1 2
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IO Combinations Would Provide Additional Value 32 Mol Cancer Ther 2018, 17(7):1494-1503 DXd ADC efficacy is enhanced by anti- PD-1/L1 antibody in preclinical models Daiichi Sankyo IO drugs + anti-PD-1/L1 antibodies Potential combinations with anti-PD-1/L1 antibodies DS-2243 (NY-ESO/HLA-A*02 T cell engager) Gocatamig (DLL3 T-cell engager) DS5361 (NMD Inhibitor) DS3610 (STING agonist ADC) Others Tumor cells APC activation against tumor antigens Tumor killing by Teff cells PD-1/L1 Durable effect by immune memory DS5361 (NMD Inhibitor) Neo-antigen increase DS-2243 (NY-ESO/HLA-A*02 T cell engager) T cell engagement/activation hHER2 expressing CT26WT mouse tumor model DS-8201: ENHERTU® Anti-PD-1 Ab DS-8201 ADC: antibody-drug conjugate, APC: antigen-presenting cell, IO: immune oncology, NMD: nonsense-mediated mRNA decay DXd ADC + IO IO + IO Gocatamig (DLL3 T cell engager) DS3610 (STING agonist ADC)
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Combinations to Expand DXd ADCs Opportunities 33 DXd ADC Immuno Checkpoint Inhibitor Targeted Therapy + + + pembrolizumab TROPION-Lung07 TROPION-Lung08 BEGONIADESTINY-Lung03 TROPION-Lung04 durvalumab pertuzumab DESTINY-Breast09 osimertinib ORCHARD TROPION-Lung14 Combinations in ongoing clinical trials (examples, not exhaustive) Ph1 or Ph2 Ph3 • ENHERTU® + EZHARMIA® (EZH1/2 inhibitor) in HER2 low mBC • DXd ADCs + IO agents (gocatamig, DS-1103 and others*) • More potential combo partners in preclinical pipeline Internal Assets AVANZAR ADC: antibody-drug conjugate, mBC: metastatic breast cancer TROPION-Lung04 rilvegostomig TROPION-Lung02 * Plan TROPION-Breast04 TROPION-Lung15 DESTINY-Gastric05 ARTEMIDE-Gastric01 bevacizumab DESTINY-Ovarian01 DESTINY-Endometrial01DESTINY-Lung06 DESTINY-BTC01 atezolizumab IDeate-Lung03 TROPION-Lung10 TROPION-Lung12 TROPION-Breast05TROPION-Breast03 DESTINY-Endometrial01
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Overall R&D Strategy 34ADC: antibody-drug conjugate Emerging clinical stage non-ADC pipeline can be leveraged to create novel combinations with existing ADCs Leverage our extensive research capabilities in ADC technology to create new ADCs Research will continue to focus on oncology & non-oncology indications In the clinical pipeline, we are prioritizing the strength of our clinical oncology pipeline
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Agenda Welcome Clinical Development Oncology Business Technology Research Q&A 1 2 3 4 5 6 35
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5 Year Performance Recap Ongoing Growth Opportunities for ENHERTU ® and DATROWAY® 2030 Ambition Oncology Business Unit Update 36
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5YBP: 5 year Business Plan, ADC: antibody drug conjugate, FY: Fiscal Year, MTP: Mid-Term Plan, JPY: Japanese Yen, PROC: platinum resistant ovarian cancer, SCLC: small cell lung cancer *Based on product sales Source: Daiichi Sankyo Financial Results Reference Data 2021 2022 2023 2024 2025 Daiichi Sankyo will start from a Position of Strength with a Growth Catalyst-Rich Year in FY2026 • Developed ENHERTU® to become the most successful ADC ever* with additional growth expected • ENHERTU® has treated 194k patients globally • Launched 2nd DXd ADC DATROWAY® • Potential for 4 standard of care changing launches in FY 2026 for ENHERTU and DATROWAY. • 3rd DXd ADC, I-DXd, received the FDA’s Breakthrough Therapy Designation in SCLC • 4th DXd ADC, R-DXd, received the FDA’s Breakthrough Therapy Designation in PROC • Two major alliances with top oncology companies • Built an organization that is focused on meeting customer needs and executes with precision and urgency Deliver 900B JPY in 5 years Product Sales Milestone Payments Fiscal Year Daiichi Sankyo Oncology Revenue Growth: FY 2021 to 2025 37
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>85 countries/ regions Commercial Footprint >40% YOY Accelerating momentum throughout the globe and major catalysts in place for 2026-27 ¥552.8B* in revenue delivered in FY 2024 with US and EU leading the way 194 K** patients across breast, lung, gastric cancer and tumor agnostic More than Achieved #1 Market share*** in 100% of fully launched countries/regions 2L HER2+ Metastatic Breast Cancer JP APPROVAL: NOV 2022 Post-chemo HER2 low Metastatic Breast Cancer Chemo naive HR+/HER2 low or ultralow Metastatic Breast Cancer 2L+ HER2 Mutant Metastatic Lung Cancer 2L+ HER2+ Metastatic Gastric Cancer**** 2L+ HER2+ (IHC3+) Metastatic Tumor Agnostic US APPROVAL: AUG 2022 | EU Approval: OCT 2023 US APPROVAL: JAN 2021 | EU Approval: DEC 2022 US APPROVAL: APR 2024 | US APPROVAL: AUG 2022 | EU Approval: JAN 2023 US APPROVAL: MAY 2022 | EU Approval: JULY 2022 US APPROVAL: JAN 2025 | EU Approval: APR 2025 JP APPROVAL: AUG 2023 JP APPROVAL: SEP 2020 JP APPROVAL: AUG 2025 JP APPROVAL: MAR 2023 *FY2024 Daiichi Sankyo Financial Results Reference Data, including gross profit share in AstraZeneca territory, does not include milestone payments **Estimated through end of fiscal Q2 2025 ***Internal market research results ****3L HER2+ metastatic gastric cancer is approved in Japan. There is no current 2L approval in Japan for metastatic gastriccancer 2L: second-line, B: billion, HR: hormone receptor, HER2: human epidermal growth factor receptor 2 IHC: immunohistochemistry, K: thousand, YOY: year over year ENHERTU®: strong global performance 38
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Daiichi Sankyo Financial Results Reference Data, including gross profit share in AstraZeneca territory, does not include milestone payments ASCA: Asia, South and Central America, Bn: billion, CAGR: compound annual growth rate,FQ: fiscal quarter, FY: fiscal year, JPY: Japanese Yen, Q: quarter 1573.4 Bn JPY cumulative global net sales since 1st launch *Incl. Gross profit share in AstraZeneca territory In the US, FY2025 Q2: 89.4Bn JPY +85% CAGR FY2020 to FY2024 +25% vs FY2024 Q2 In Europe, FY2025 Q2: 42.1 Bn JPY +155% CAGR FY2021 to FY2024 +19% vs FY2024 Q2 US EU In Japan, FY2025 Q2: 9.6 Bn JPY +63% CAGR FY2020 to FY2024 +23% vs FY2024 Q2 In ASCA, FY2025 Q2: 22.1 Bn JPY +123% CAGR FY2022 to FY2024 +28% vs FY2024 Q2 Japan ASCA Global net sales in FY2025 Q2 totaled 163.2 Bn JPY; +107% CAGR FY2020 to FY2024; +24% vs FY2024 Q2 3.2 5.2 7.1 8.4 9.4 13.0 13.816.821.9 31.3 48.3 60.2 67.8 81.7 91.6 102.6 119.9 129.6 131.7 143.1 148.4 155.2 163.2 US Europe Japan ASCA ENHERTU® GLOBAL NET SALES BY REGION (Bn JPY) Daiichi Sankyo has delivered by maximizing ENHERTU® since our launch in FY2019 and created the most successful launch in oncology over the last 5 years 39
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~125K ENHERTU ® G7 ELIGIBLE PATIENTS IN BREAST CANCER BY 2030 ENHERTU® BC Priorities* HER2+ BC HER2-low BC • Move earlier, creating urgency to treat with ENHERTU® post 2L ET in most eligible patients based on DB-06 • Expand to a broader population: quickly identify ultralow patients • Establish new 1L standard of care based on DB-09 • Move to the eBC curative setting based on DB-11 and DB-05 1L: first line, 2L: second line, ET: endocrine therapy, G7: US, Japan, France, Germany, Italy, Spain, UK; eBC: early breast cancer, HER2: human epidermal growth factor receptor 2 *pending approvals The next two years are pivotal for ENHERTU® in breast cancer with multiple data catalyst and new launches 40
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*Based on internal market research. DESTINY- Breast06 has launched in Germany, but additional European markets are awaiting reimbursement **P-value of <0.015 required for statistical significance; Data according to ASCO 2024 presentation 2L: second line, BICR: blinded independent central review, BC: breast cancer, CI: confidence interval, HR: hormone receptor, HER2: human epidermal growth factor receptor 2, PFS: progression free survival, Q: quarter, TPC: treatment of physician's choice DESTINY-Breast06 Clinical trial data: PFS (BICR) in HER2 low and ultralow Market share trend* HR+ HER2 low 2L+ Chemo naïve patients (US) Fiscal Q3 2024 (p=234) Fiscal Q2 2025 (p=341) ENHERTU® US market share has seen robust expansion following DB-06 approval in the chemo- naïve setting. Launch status by countries and regions US Approval 2025.Jan EMA Approval 2025.Apr JP Approval 2025.Aug 2026+ ~35% ≥50% DESTINY-Breast06: ENHERTU® adoption in HR+ HER2 low BC continues to expand 41 Hazard ratio 0.63 95% CI 0.53–0.75 P<0.0001**
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*Median PFS estimate for T-DXd + P is likely to change at updated analysis; †stratified log-rank test. A P-value of <0.00043 was required for interim analysis superiority BICR, blinded independent central review; CI, confidence interval; mo, months; (m)PFS, (median) progression-free survival; NC, not calculable; P, pertuzumab; T-DXd, trastuzumab deruxtecan, ENHERTU®; THP, taxane + trastuzumab + pertuzumab HER2: human epidermal growth factor receptor 2, mBC: metastatic breast cancer, K: thousand G7 consists of the US, Japan, France, Germany, Italy, Spain and United Kingdom DESTINY-Breast09 Clinical trial data: PFS (BICR) External Excitement for 1L HER2+ mBC Statistically significant and clinically meaningful PFS benefit with T-DXd + P (median Δ 13.8 mo) ~24,000* Market opportunity in G7 • Currently, ~30% of patients do not receive treatment beyond first line. *Incremental to 2L Eligible patients: ~7,000 “This is a pivotal advancement for the treatment of HER2-positive metastatic breast cancer” The strong results in delaying progression “make it a clear front-runner” as an initial treatment for HER2 patients STAT Bloomberg Market Opportunity (Eligible patient numbers) DESTINY-Breast09: Launch of ENHERTU® in 1st Line HER2+ mBC will be a near-term growth catalyst with potential to benefit 24k eligible patients 42
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1L: first line, cTX: chemotherapy, ESMO: European Society of Medical Oncology, eBC: early Breast Cancer, HER2: human epidermal growth factor receptor 2, mOS: median overall survival, mo: months, mBC: metastatic breast cancer, ORR: overall response rate, pCR: pathological complete response, PDx: Programmed Cell Death (Ligand) Inhibitors, T-DM1: trastuzumab emtansine, THP, taxane + trastuzumab + pertuzumab, TNBC: triple negative breast cancer Moving ENHERTU® into early HER2+ breast cancer Broadening potential of DATROWAY® • 67% pCR with early trend to EFS benefit • Highest reported pCR rate seen in a Phase III registrational trial in this setting • 53% reduction in risk of disease recurrence or death vs T-DM1 • >92% patients free of invasive disease at 3 years Together, demonstrate the potential of ENHERTU® as a foundational treatment in curative-intent eBC DESTINY-Breast11 Neoadjuvant ENHERTU® → THP High-risk HER2+ eBC DESTINY-Breast05 Post-neoadjuvant ENHERTU® High-risk HER2+ eBC • Unprecedented mOS improvement of 5 mo vs CTx • Robust anti-tumor activity with 63% ORR • First ever trial to show a mOS benefit in 1L TNBC in patients where immunotherapy was not an option TROPION-Breast02 DATROWAY® 1L TNBC not suitable for PDx Daiichi Sankyo @ ESMO 2025: Three Landmark Trials Showcase Potential Practice-Changing Results in Breast Cancer 43
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BC: breast cancer, CI: confidence interval, DB: DESTINY-Breast, IDFS: invasive disease-free survival, ITT: intention to treat, HR: hormone receptor, HR: hazard ratio, G7: US, Japan, France, Italy, Germany, Spain, and United Kingdom ddAC-THP: doxorubicin + cyclophosphamide followed by taxane + trastuzumab + pertuzumab *FirstWord Pharma physician survey results (n=140 US and EU oncologists), published November 19th DESTINY-Breast11/05 Clinical trial data Market Opportunity (Eligible patient numbers) External Excitement for DESTINY-Breast11 / 05* DB-11: ~29,000 DB-05: ~11,000 Market opportunity in G7 Question: Which single statement best captures your initial takeaway from the DB-11 and DB-05 studies? (% of US and EU oncologists) Enhertu looks practice-changing in both neo- and post-neoadjuvant settings More compelling in post-neoadjuvant than neoadjuvant Signals are promising but I need longer follow-up/safety Data are insufficient to change practice now 72% DESTINY-Breast11, DESTINY-Breast05: Launches of ENHERTU® in early- stage BC will present significant growth catalysts 44
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Destiny -Breast09 *Adjuvant therapy for patients with residual invasive disease following neoadjuvant therapy 1L: first-line, 2L: second-line, HER2: human epidermal growth factor receptor 2, HR: hormone receptor, NSCLC: non-small cell lung cancer, PD-L1: programmed cell death ligan 1, pMMR: mismatch repair proficient Potential new indications could benefit ~100k additional eligible patients by 2030 HER2 positive metastatic breast cancer (1L) HER2 positive early breast cancer (neoadjuvant) HER2 positive early breast cancer (adjuvant*) LUNG AND GASTRIC INDICATIONS: ~5k eligible patients BREAST INDICATIONS: ~50k eligible patients FY 2025-2026 Potential New Indications HER2 positive gastric cancer (2L) HER2 mutant metastatic NSCLC (1L) = Positive TLR achieved Potential New Indications 2027+ HER2 positive gastric cancer (1L) HER2 positive biliary tract cancer (1L) HER2 positive ovarian cancer (1L) HER2 positive, PD-L1 <50% NSCLC (1L) HER2 positive pMMR endometrial cancer (1L) HER2 positive early endometrial cancer (adjuvant) PAN TUMOR INDICATIONS: ~45k eligible patients DESTINY-Breast11 DESTINY-Breast05 DESTINY-Gastric04 DESTINY-Lung04 DESTINY-Gastric05 DESTINY-BTC01 DESTINY-Ovarian01 DESTINY-Lung06 DESTINY-Endometrial01 DESTINY-Endometrial02 ENHERTU® is DESTINED for more as key clinical trial results and new indications seek to go earlier and broader 45
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1.4 5.3 10.4 FQ4'24 FQ1'25 FQ2'25 US Europe Japan ASCA Daiichi Sankyo Financial Results Reference Data, including gross profit share in AstraZeneca territory, does not include milestone payments *Datroway® has launched in Germany, but reimbursement negotiations are ongoing ASCA: Asia, South and Central America, Bn: billion, EGFRm: epidermal growth factor receptor mutant, FQ: fiscal quarter, FY: fiscal year, mBC: metastatic Breast Cancer, NSCLC: non-small cell lung cancer, JPY: Japanese Yen, Q: quarter, QtQ: quarter to quarter 17.1 Bn JPY cumulative global net sales since 1st launch In the US, FY2025 Q2: 6.6 Bn JPY +112.9% vs. prior quarter Sales driven by HR+ HER2- mBC and EGFRm NSCLC US Overall, global net sales in FY2025 Q2 was 10.4 Bn JPY; +95.9% sequential QtQ growth driven by US and Japan DATROWAY® GLOBAL NET SALES BY REGION (Bn JPY) DATROWAY® was approved by the EMA in April 2025 Launches expected throughout 2026 EU In Japan, FY2025 Q2: 3.5 Bn JPY +59.1% vs. prior quarter JP Global DATROWAY® net sales have now exceeded 10 Bn JPY in Q2 FY ‘25 46
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DATROWAY® indication expansion expected in 2026 Build the foundation as the preferred TROP2 ADC with positive first experiences in efficacy and tolerability Drive rapid adoption as first TROP2 ADC approved in NSCLC for a range of EGFR mutations ENTRENCH as new SOC and the only TROP2 ADC to demonstrate overall survival HR+/HER2- mBC EGFRm NSCLC IO ineligible mTNBC ADC: antibody drug conjugate, EGFR: epidermal growth factor receptor, FY: fiscal year, HR: hormone receptor, HER2: human epidermal growth factor receptor 2, mBC: metastatic breast cancer, NSCLC: non-small cell lung cancer, SOC: standard of care, TNBC: triple negative breast cancer, TROP2: Trophoblast cell-surface antigen 2 Early adoption and experience is building confidence amongst prescribers and we expect accelerating performance in FY2026 47
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1. Dent R et al. Presented at: ESMO 2025; October 17-21, 2025; Berlin, Germany. Presentation LBA21 2. https://pubmed.ncbi.nlm.nih.gov/38601487/ 3. https://pubmed.ncbi.nlm.nih.gov/37229447 4. https://ascopost.com/issues/august-25-2023/new-challenge-in-triple-negative-breast-cancer-optimizing-the-sequencing-of-treatments/ 5. National Cancer Institute SEER Program. Available at: https://seer.cancer.gov/statfacts/html/breast-subtypes.html 6. Punie K, et al. Oncologist 2025;30:oyaf034; 7. Traina T, et al. Clin Cancer Res 2025;31:P3-08-10; 8. Li CH, et al. Breast Cancer Res 2019;21:143 1L: first line, BRCA: Breast cancer gene, DOR: Duration of response, ICC: investigators choice chemo, G7: US, Japan, France, Germany, Italy, Spain, United Kingdom, mo: months, ORR: overall response rate, OS: overall survival, PD-L1: programmed cell death ligand, PFS: progression free survival, TRAE: treatment related adverse events, TNBC: triple negative breast cancer TROPION-Breast02 Clinical trial data Market Opportunity (Eligible patient numbers) Market Insights (Triple Negative Breast Cancer) TB02: ~16,000 Market opportunity in G7 Dato-DXd ICC Δ Median PFS 10.8 mo 5.6 mo Δ 5.3 mo Median OS 23.7 mo 18.8 mo Δ 5.0 mo Median DOR 12.3 mo 7.1 mo Δ 5.2 mo Despite more than double the duration of treatment, rates of grade ≥3 and serious TRAEs were similar, and discontinuations were lower, with Dato-DXd vs ICC • For nearly 15 years, there have been no new treatment advancements in 1L mTNBC for patients who are PD-L1- negative, non-BRCA mutated, or not candidates for immunotherapy. 2,3,4 • Advanced/metastatic TNBC is the most aggressive cancer subtype with the fewest treatment options; Metastatic TNBC 5 - year OS: 14.9% 5 ~70% not candidates for 1L immunotherapy6 ~50% do not receive treatment beyond 1L6,7 TROPION-Breast02 study showed a statistically significant & clinically meaningful improvement in PFS and OS compared with ICC 48
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Cht: chemotherapy, DFI: disease free interval, ESMO: European Society of Medical Oncologists, HCP: Healthcare Professional, KEE:Key External Expert, M: million, TNBC: triple negative breast cancer, TROP2: Trophoblast cell-surface antigen 2 *Coverage as of Oct. 20, 2025, 3PM ET / 8 PM ET The Pharma Letter ESMO 2025: Daiichi Sankyo and AstraZeneca’s DATROWAY Results ‘Unprecedented’ OncLive TROPION-Breast02 Data Support Dato-DXd as New First-Line Standard of Care in TNBC ApexOnco “Both agents impressed, but the results (of TROPION-Breast02) suggest that DATROWAY could have an edge” BioPharma Dive AstraZeneca, Daiichi’s DATROWAY Excels in Hard-to-Treat Breast Cancer BioPharma Dive Dato-DXd Doubles Response Rates and Extends Survival in First- Line Metastatic TNBC Fierce Pharma ESMO: AZ, Daiichi’s DATROWAY Outshines Gilead’s Trodelvy in First Global TROP2 Showdown Endpoints News “DATROWAY appears to offer numerically better progression-free survival data” “I was amazed when I saw the more than doubling of response and tripling of CR with Dato-DXd” - Asia-Pacific KEE “The low ILD rate with Dato-DXd is amazing” - Asia-Pacific KEE “Patients with short DFI have poor prognosis, so it is great to have an option other than ChT” - Europe KEE Media and KEEs Highlight ‘Unprecedented’ DATROWAY® Data in TNBC 49
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*TROPION-Breast01 indication: HR+/HER2- (IHC0, 1+ or 2+/ISH-) mBC mBC: metastatic breast cancer, HER2: human epidermal growth factor receptor 2, HR: hormone receptor, IHC: immunohistochemistry, ISH: in situ hybridization, TNBC: triple negative breast cancer Source: npj Breast Cancer volume 7, Article number: 1 (2021) Readout / In progress Readout With DATROWAY®’s potential indications in TNBC, Daiichi Sankyo’s oncology portfolio has the potential to benefit 100% of mBC patients 50
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1L: first line, 2L: second line, AGA: actionable genomic alteration, EGFRm: epidermal growth factor receptor mutant, NMR: normalized membrane ratio, NSCLC: non-small cell lung cancer, NSQ: non- squamous, PD-L1: programmed cell death ligand, TNBC: triple negative breast cancer, TPS: tumor proportion score, TROP2: trophoblast cell surface antigen 2 *Adjuvant therapy for patients with residual invasive disease following neoadjuvant therapy EGFRm NSCLC, , DATROWAY® + osimertinib (1L) NSQ non-AGA TROP2 NMR+ NSCLC (2L+) LUNG INDICATIONS: ~70k eligible patients BREAST INDICATIONS: ~46k eligible patients Expected TLRs in FY 2027+ Early TNBC (Adjuvant*) Metastatic Urothelial Carcinoma (2L+) Early TNBC (Neoadjuvant) NSQ non-AGA NSCLC, PD-L1 TPS ≥ 50% (1L) TNBC, not an option for PD-1/PD-L1 (1L) TNBC, PD-L1 positive (1L) LUNG INDICATIONS: ~160k eligible patients NSQ non-AGA NSCLC (1L) NSQ non-AGA NSCLC, PD-L1 TPS < 50% (1L) NSQ non-AGA NSCLC, PD-L1 TPS ≥ 50% (1L) EGFRm NSCLC, DATROWAY® +/- osimertinib (2L+) BREAST INDICATIONS: ~24k eligible patients Expected TLRs in FY2025 - 2026 = Positive TLR achieved OTHER INDICATIONS: ~15k eligible patients TROPION-Breast02 TROPION-Breast05 AVANZAR TROPION-Lung15 TROPION-Lung07 TROPION-Lung08 TROPION-Breast03 TROPION-Breast04 TROPION-Lung10 TROPION-Lung14 TROPION-Lung17 TROPION-Urothelial03 Potential future indications can significantly expand the patients DATROWAY® can benefit 51
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ADC: antibody drug conjugate, k: thousand, CRPC: castration resistant prostate cancer DB: DESTINY-Breast, DL: DESTINY-Lung, DG: DESTINY-Gastric, EGFRm: epidermal growth factor receptor mutant, ESCC: esophageal squamous cell carcinoma, FY: fiscal year, PROC: platinum resistant ovarian cancer, SCLC: small cell lung cancer TL: TROPION-Lung, TB: TROPION-Breast, TLR: top line results WW: worldwide *Arrow size is Illustrative FY2025 WW Target • TROPION-Lung05 • TROPION-Breast01• DESTINY-Breast06 • DESTINY-Gastric04 • DESTINY-Breast09 • DESTINY-Breast11 • DESTINY-Breast05 • DESTINY-Lung04 • DESTINY-Lung06 • DESTINY-Gastric05 • AVANZAR • TROPION-Lung07 • TROPION-Lung08 • TROPION-Lung10 • TROPION-Lung14 • TROPION-Lung15 • TROPION-Breast02 • TROPION-Breast03 • TROPION-Breast04 • TROPION-Breast05 • TROPION-Urothelial03 • IDeate-Lung01 • IDeate-Lung02 • IDeate-Esophageal01 • IDeate-Prostate01 • REJOICE-Ovarian01 FY2030 ENHERTU® Growth DATROWAY® Debut DATROWAY® Growth US Merck Alliance Others ~120k Eligible Patients ~700k Eligible Patients = Positive TLR achieved Daiichi Sankyo plans to launch numerous indications across at least 4 ADCs by 2030, contributing nearly six times as many patients 52
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Source: Evaluate Pharma, accessed November 19, 2025 *MAT = Moving Annual Total (MAT Sept 2025 refers to Oct 2024 – Sept 2025 period B: billion, Co: company, GSK: GlaxoSmithKline, KGaA: Kommanditgesellschaftauf Aktien 0 5 10 15 20 25 30 35 GLOBAL ONCOLOGY PRODUCT SALES ($B) Daiichi Sankyo remains highly confident we will reach and exceed our goal to be a top 10 oncology company 53
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Agenda Welcome Clinical Development Oncology Business Technology Research Q&A 1 2 3 4 5 6 54
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Ensuring stable supply across countries and regions while responding to rapidly increasing demand since the launch of ENHERTU® Establishing a global supply system capable of meeting peak demand for all 5DXd ADCs Development Status and Stable Supply System for 5DXd ADCs 55 Steady market penetration and expansion of approved countries and regions through the strategic partnership with AstraZeneca (more than 85 countries and regions) Further growth driven mainly by the U.S. and Europe (Global product sales: ¥261.3 billion in H1 FY2024 and ¥318.4 billion in H1 FY2025) Development Status ENHERTU® Stable Supply System Approved in more than 35 countries and regions, including Japan, the U.S., and Europe Strong sales ramp-up in Japan and the US DATROWAY® Maximizing product potential through a strategic partnership with US Merck* Positive clinical trial data accumulating for I-DXd and R-DXd HER3-DXd I-DXd R-DXd * Merck & Co., Inc., Rahway, NJ, USA
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Supply Strategy for 5DXd ADCs 56 Production Capacity: Expansion of Capacity • Enhancement of production capacity through capital investment • Establishment and expansion of a global supply system Productivity: Enhancement of Capability • Further improvement of productivity by leveraging technology • Development and strengthening of biotechnology specialist • Transformation into a high-productivity organization Expansion of Capacity Enhancement of Capability Maximization of supply volume× ＝
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ADC Manufacturing Process 57 ADCs are composed of multiple components, which are manufactured and managed separately The manufacturing process involves many steps, resulting in a lead time significantly longer than that of small- molecule drugs (typically over one year) Antibody Drug-Linker Drug Linker Drug Substance Drug Product Deruxtecan Conjugation Fill & Lyophilization ADC Product Secondary packaging Ex: ENHERTU®
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Global Supply Overview 58 Utilizing both in-house manufacturing and multiple CMO(Contract Manufacturing Organizations) to establish diversified manufacturing and supply routes for each product Securing sufficient capacity to meet rapid demand growth and reducing supply risks from unexpected issues CMO A CMO B In-house A In-house B CMO A CMO B CMO A CMO C In-house A In-house B In-house A In-house B In-house C CMO A In-house A In-house B CMO A CMO B In-house A In-house B In-house C In-house C CMO B JP US EU Other Logistics Warehouse Delivery Antibody ADC BDS Drug product PackagingDrug Linker In-house Manufacturing Site CMO Manufacturing Site Critical processes with significant impact on product quality Supply can be continued through alternative routes even if an unexpected issue disrupts one route *The supply routes are illustrative and differ from the actual supply structure
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Approach to In-House Facilities and CMO Utilization 59 Adjusting manufacturing and supply volumes based on the latest demand forecasts, while enhancing overall capacity through capital investments and CMO partnerships In the short term, effectively leverage existing CMO capabilities to prioritize speed; in the long term, promote in- house capital investments to optimize cost and ensure a stable supply Capacity Demand Forecast Number of Vials In-house manufacturing capacity CMO manufacturing capacity Leverage CMOs effectively Leverage in-house and CMO capabilities in balance Ensure supply capacity exceeds demand IllustrationDemand Capacity (CMO) Capacity (In-house) Illustration Difference in Product Launch Lead Time Between CMOs and In-House Manufacturing In contrast to CMOs that already have existing manufacturing equipment or facilities, expanding in-house manufacturing capacity requires a longer lead time
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Global In-House Manufacturing Sites 60 Hiratsuka Kitamoto Odawara Tatebayashi Onahama Pfaffenhofen, Germany Alphaville, Brazil Altkirch, France Shirley, NY Hilliard, Ohio New Albany, Ohio Shanghai, China Building an ADC supply structure through seven in-house sites and multiple CMOs Brea, CA mAb Antibody Site ADC Drug Substance SiteDS DP ADC Drug Product Site mAb DS DP Investments underway or planned Investments underway or planned Investments underway or planned mAb DS DP mAb mAb DS DP DP DS DP
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Antibody Supply System 61 Effectively leveraging CMO speed and technical capabilities at present Strengthening in-house supply capabilities over the mid- to long-term to build a low-cost, stable supply system Onahama Site - Antibody Building • Completion: FY2024 • Antibody manufacturing equipment (multi-use) • Cultivation: 15 kL × 3 bioreactors, Purification: 1 line • All processes located on the same floor to shorten workflow paths • Upstream cultivation on the upper floor and downstream purification on the lower floor to minimize loss during process transfer Upstream Cultivation and Purification Processes Downstream Water Purification Utilities HVAC equipment Electrical equipment Outdoor Equipment Area
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ADC Drug Substance Supply System 62 Requiring dedicated facilities and advanced technical capabilities for ADC drug substance manufacturing, a stable supply system is being built through in-house facilities and selected CMOs Completing new ADC drug substance facilities at the Hiratsuka Site in Feb 2026, with comparable capacity under construction at the Pfaffenhofen Site in Germany Hiratsuka Site – ADC Drug Substance Building • Completion: FY2025 (planned) • Drug substance manufacturing equipment (multi -use) • Drug substance: 1,200 L × 2 lines Completion Illustration Pfaffenhofen Site - ADC Building F5 • Completion: FY2028 (planned) • Drug substance & Drug Product manufacturing equipment (multi-use) • Drug substance: 1,200 L × 2 lines
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ADC Drug Product Supply System 63 Building regional supply system worldwide based on a “LOCAL PRODUCTION FOR LOCAL CONSUMPTION” approach A new drug product line is scheduled for completion in FY2026 atAmerican Regent’s New Albany site in the US New Albany（US） • One drug product line scheduled for completion in FY2026 Pfaffenhofen（Germany） • F4：One drug product line completed in FY2024 • F5：Two drug product lines scheduled for completion in FY2028 Shanghai（China） • Two drug product lines scheduled for completion in FY2027 F5 F4 Completion Illustration F5：Completion Illustration Hiratsuka（Japan） • One drug product line completed in FY2019 • Two drug product lines completed in FY2023
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Advantage of One-Stop Manufacturing Approach 64 ADCs require multiple manufacturing steps, resulting in longer lead times than small-molecule drugs (over one year from start of production to finished product) Consolidating key manufacturing processes at a single site reduces inter-site transportation time and enhances production flexibility Onahama Site （Antibody～Drug substance） 3F：ADC Drug substance line 1F：Antibody line transportation Hiratsuka Site （Drug substance～Drug product） Sterile Formulation Building No.2 ADC Drug Substance Building Established an efficient production system by integrating antibody and drug substance manufacturing within a single building Established an integrated manufacturing system manufacturing from Drug substance to Drug product & packaging
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Strengthening Recruitment Activities • Internship programs targeting students • Proactive mid-career hiring to secure experienced talent Accelerate the Early Development and Strengthening of Manufacturing Operators through Training Programs • Establish dedicated training environments for manufacturing engineers • Develop and implement the “Manufacturing Operator Training Program” Seamless talent exchange across organizational and functional boundaries • Engineer training coordinated across global manufacturing sites • Cross-regional talent exchange on a global scale Recruitment enhancement Training programs Seamless talent exchange Development and Strengthening of Biotech Specialists Develop and strengthen biotech specialists (process development, manufacturing, quality assurance, regulatory affairs, etc.) to ensure ADC product development and stable supply In the manufacturing function, securing more production staff and accelerating operator training is essential to meet increasing production demands. Initiatives to Develop and Strengthen Biotech Specialist 65
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Establish training environments for antibody manufacturing operators Develop training programs for antibody manufacturing operators and achieve efficient development of biotech specialists Cell culture Purification • Theory-based training • Media preparation • Cell thawing to main culture • Operation training for Single-Use Equipment • Theory-based Training • Purification via various chromatography steps through concentration and diafiltration (UF/DF *) * Ultrafiltration/Diafiltration • Small-group, practice-oriented program • Skill development using lab-scale, training-dedicated equipment • Enhanced process comprehension through integrated theoretical and practical trainings • OJT and GMP training at each manufacturing sites Lecture GMP Training Lab scale OJT Actual Appr. 6 Month Accelerate the Early Development and Strengthening of Manufacturing Operators through Training Programs 66
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■ Transition to an integrated organization covering clinical to commercial manufacturing Environmental Changes Shift in major production items from small molecules to oncology and new modalities Shorter lead times from development to commercial manufacturing due to accelerated approval processes Tech research Tech development Clinical Site selection Clinical mfg Clinical Supply & Demand mgmt Clinical Logistics Comm. Site selection Comm. mfg Comm. Supply & Demand mgmt Comm. Logstics Led by Technology Unit Led by Bio*1/PT*2 Led by SC*3■As Is Separate organizations for clinical and commercial manufacturing, leading to communication gaps and functional redundancies ■To Be Integrate clinical and commercial management to enable a seamless end- to-end process, improving information sharing and eliminating functional redundancies Shift from a separated clinical/commercial manufacturing structure to a unified organization that leads both areas together *1 Biologics Unit *2 Pharmaceutical Technology Unit *3 Supply Chain Unit Organizational Optimization to Meet Environmental Changes 67
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Biologics Pharmaceutical Technology Supply Chain FY2022 Biologics Pharmaceutical Technology Supply Chain FY2023 Technology Unit FY2024 • Strategy, Planning, General Affairs, and Talent Dev. • CMC Management • Research and Technical Dev. • Supply Chain Management • CMC Regulatory Affairs • Plant Management Establish a unified Technology Unit through the integration of the Biologics, Pharmaceutical Technology, and Supply Chain Unit Redesigned unit functions to enhance operational efficiency and optimization Technology Unit FY2025 • Strategy, Planning, General Affairs, and Talent Dev. • CMC Management • Research and Technical Dev. • Supply Chain Management • CMC Regulatory Affairs • Plant Management Absorbed DS Propharma and DS Chemical Pharma to strengthen integration across manufacturing functions Technology Unit Daiichi Sankyo Propharma Daiichi Chemical Pharma ■ Evolution of the Technology Establish an integrated structure that works seamlessly from early development through commercial manufacturing and supply, enabling more efficient support for ADC and oncology businesses Organizational Optimization to Meet Environmental Changes 68
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Agenda Opening Clinical development Oncology business Technology Research Q&A 1 2 3 4 5 6 69
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Daiichi Sankyo Takes Multi-Modality Strategy 70 Establishing proprietary technologies unique to Daiichi Sankyo and building a robust and competitive drug discovery platform across diverse modalities. Continuous Generation of Innovative Medicines that Transform the SOC DXd ADC Multispecific Antibody Nucleotide Gene Therapy Glycan LNP-mRNA etc. mPBD ADC ADC Platform New Modalities (beyond ADC) STING agonist ADC Neｗ Concept ADCs Mid-size Molecule (incl. TPD molecule) LNP: lipid nanoparticles, mPBD: modified pyrrolobenzodiazepine, SOC: Standard of Care, TPD: Targeted Protein Degradation
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ADCs DXd and New-concept • Leverage deep DXd ADC experience • Expanding value across tumor types • High clinical success probability Immuno- Oncology (IO) • Long-term remission via immune memory • DXd ADC and IO combinations with complementary mechanisms • Innovative approaches for cancers with high unmet needs Combination Strategy • Building the next standard of care • Enhancing portfolio leverage • Combining DXd ADCs and new MoA Deliver Durable Patient Benefit and Maximize Portfolio Value New Modalities • Establishing the technological advantages in multi-modality • Long-term growth options • Accelerating the innovation through partnership/collaboration Smart Lab / Open Innovation • Accelerating research productivity and scientific innovation through digital technology / external expertise Today’s Topics for Our Future Innovation 71ADC: antibody-drug conjugate, MoA: Mode of Action
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ADCs DXd and New-concept • Leverage deep DXd ADC experience • Expanding value across tumor types • High clinical success probability Immuno- Oncology (IO) • Long-term remission via immune memory • DXd ADC and IO combinations with complementary mechanisms • Innovative approaches for cancers with high unmet needs Combination Strategy • Building the next standard of care • Enhancing portfolio leverage • Combining DXd ADCs and new MoA Deliver Durable Patient Benefit and Maximize Portfolio Value New Modalities • Establishing the technological advantages in multi-modality • Long-term growth options • Accelerating the innovation through partnership/collaboration Smart Lab / Open Innovation • Accelerating research productivity and scientific innovation through digital technology / external expertise Today’s Topics for Our Future Innovation 72ADC: antibody-drug conjugate, MoA: Mode of Action
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Long history behind the birth of DXd ADC 73 1980s Irinotecan（CPT-11） Co-development w/ Yakult 1990s Potent Topo I inhibitor, Exatecan （Ph3 terminated） 2000s R&D of DDS （DE-310, Ph1 terminated） 2013 Preclinical studies 2015 Clinical trial initiated Biologics Topo I inhibitors R&D of ENHERTU® 2007 merged Cross-functional activity for ADC research Daiichi Pharmaceutical Co., Ltd. 1990s Humanization Small-scale manufacturing (Anti CD95, anti- DR5) 2000s Establishment of mAb screening / Expansion of mAb portfolio / Establishment of large-scale manufacturing / M&A (Denosumab etc.) Sankyo Co., Ltd. Our research culture includes… Great history of delivering unique value for patients Insatiable passion in the pursuit of new science & technology Emphasis creativity and insistence on perfection DXd ADCs +”Beyond DXd ADC” drugs 2019 1st indication approved Several inventors of ENHERTU® have been involved in other launched products They have long tenure at DS, leveraged their expertise and are now research leaders growing our future talent 1990 2000 20202010 5DXd ADCs & Next Wave DDS: drug delivery system, DS: Daiichi Sankyo, mAb: monoclonal antibody
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Asset (Target Antigen) Target tumor Pre-Clinical Ph1 Ph2 Ph3 Filed Launched DXd ADCs ENHERTUⓇ (HER2) BC, GC, NSCLC, Solid Tumors DATROWAYⓇ (TROP2) BC, NSCLC, etc. I-DXd (B7-H3) SCLC, ESCC, CRPC, etc. R-DXd (CDH6) OVC, RCC, etc. HER3-DXd (HER3) BC, GC, Melanoma etc. DS-3939 (TA-MUC1) Solid Tumors DS3790 (CD37) Hematological malignancies Timeline indicates the most advanced stage of each asset, and that status may not apply to all tumors listed in the “target tumor” column ADC: antibody-drug conjugate, BTC: biliary tract cancer, CRC: colorectal cancer, CRPC: chemotherapy-resistant prostate cancer, ESCC: esophageal squamous cell carcinoma, GC: gastric cancer, HCC: hepatocellular carcinoma, NSCLC: non small cell lung cancer, OVC: ovarian cancer, RCC: renal cell carcinoma, SCLC: small cell lung cancer DXd ADC is Daiichi Sankyo Original ADC Technology Platform 74 Our ADC technology platform is growing, and we have generated 7DXd ADCs from the technology
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External Evaluation of DXd ADC Technology Timing Indications August 2017 Third-line treatment for HER2-positive breast cancer May 2020 Second-line treatment for HER2 gene mutation-positive non-small cell lung cancer May 2020 Third-line treatment for HER2-positive gastric cancer September 2021 Second-line treatment for HER2-positive breast cancer April 2022 Low HER2 expression breast cancer (previously treated with chemotherapy) September 2023 HER2-positive colorectal cancer (third-line treatment and beyond) September 2023 Second-line or later treatment for HER2-positive solid tumors August 2024 HR-positive and HER2-low/ultra-low breast cancer (chemotherapy-naive) July 2025 HER2-positive breast cancer first-line treatment HER3-DXd Since 2017, a total of 13 Breakthrough Therapy designations* have been granted in the United States Timing Indication December 2024 EGFR-mutated non-small cell lung cancer with prior treatment history, including EGFR-targeted therapy Timing Indication December 2021 Third-line treatment for EGFR-mutated non-small cell lung cancer Timing Indication August 2025 Extensive-stage small cell lung cancer I-DXd *Breakthrough Therapy Designation: A program established to expedite the development and review of drugs that may demonstratea greater therapeutic effect than existing treatments for serious conditions, enabling faster delivery of new drugs to patients in the US. Timing Indication September 2025 CDH6 expressing platinum-resistant ovarian cancer R-DXd 75
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Payload FIC/BIC Cytotoxic payloads • DXd, mPBD, etc. Other new payloads for refractory/resistant tumors • IO payloads, etc. Antibody Unique binders targeting disease specific proteins and glycans Fc engineering Novel technologies to increase specificity Linker DAR control Site specificity Novel conjugation Our Proprietary Technologies X ADC-leading Expertise 15+ years of continuous ADC platform innovation Exploration of diverse MoA - based payloads Extensive validation of dozens of tumor antigens Deep expertise from broad linker-payload conjugation Unique ADC Research Experience Enabling Ongoing Breakthroughs PayloadLinkerAntibody The Evolution of Our ADC Technologies Will Continue 15 years of ADC platform advancement - expanding Innovation 76ADC: antibody-drug conjugate, BIC: best in class, DAR: drug antibody ratio, FIC: first in class, IO: immuno-oncology, mPBD: modified pyrrolobenzodiazepine
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New Concept ADC 4 • • New Concept ADC 3 • ・ • ・ Sustainable ADC Platform Development 77 DXd ADC ENHERTU® DATROWAY® I-DXd R-DXd HER3-DXd DS-3939 DS3790 DS-9606 Expanding into new technology in discovery stage STING agonist ADC DS3610 Multiple projects in preclinical stage New Concept ADC 1 Multiple projects in discovery stage New Concept ADC 2 Multiple projects in discovery stage 1 2 3 4 5 mPBD ADC ADC: antibody-drug conjugate, mPBD: modified pyrrolobenzodiazepine
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Today’s Topics for Our Future Innovation 78 ADCs DXd and New-concept • Leverage deep DXd ADC experience • Expanding value across tumor types • High clinical success probability Immuno- Oncology (IO) • Long-term remission via immune memory • DXd ADC and IO combinations with complementary mechanisms • Innovative approaches for cancers with high unmet needs Combination Strategy • Building the next standard of care • Enhancing portfolio leverage • Combining DXd ADCs and new MoA Deliver Durable Patient Benefit and Maximize Portfolio Value New Modalities • Establishing the technological advantages in multi-modality • Long-term growth options • Accelerating the innovation through partnership/collaboration Smart Lab / Open Innovation • Accelerating research productivity and scientific innovation through digital technology / external expertise ADC: antibody-drug conjugate, MoA: Mode of Action
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Why We Invest in IO? Immuno-Oncology (IO) Franchise 79 Durable Effect IO therapies can deliver long-lasting remission beyond the treatment period. Immune Memory Activated immune cells ‘remember’ tumor antigens and suppress recurrence over time. New Treatment Opportunities IO mechanisms create new treatment options for cancers less responsive to cytotoxic agents. Combinations therapy with complementary mechanisms IO × DXd ADC combinations maximize the value of our internal assets and possibly provide new SOC. Unlocking durable benefit, expanding treatment options, and maximizing internal asset value. ADC: antibody-drug conjugate, IO: immuno-oncology, SOC: standard of care,
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Our 10 Years Research History Has Built the IO Franchise 80 ■Small molecule APC: Antigen presenting cells, IO: immuno-oncology, TCE: T-call engager ■New modality (ADC, TCE) ■Antibody Treg inhibition Teff cell stim. by APC Treg cells Neo-antigen increase • DS5361 (Ph1) APC activation • DS-1103 (Ph1) • DS3610 (Ph1) T cell engagers (TCE) • DXd ADCs Tumor cell death APC activation Tumor killing by Teff cells Tumor neo-antigens Cancer cell death Anti-CCR8 Ab • DS-2243 (Ph1) • Gocatamig (Ph1/2) Anti-PD1/L1 Ab Leveraging a multi-modality strategy, we are establishing a portfolio that targets and activates key mechanisms in IO signaling Cancer Vaccine
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DS3610: New STING Agonist ADC 81ADC: antibody-drug conjugate, FIH: first-in human Tumor cell DS3610 Antigen presenting cell T cell ADC that combines Daiichi Sankyo original STING agonists with an antibody The novel Fc modification technology reduces the risk of systemic cytokine release Activation of immune cells including antigen presenting cells and T cells, and durable antitumor activity by immune memory formation have been confirmed in preclinical studies Combination effect with various therapeutic agents has been observed The FIH study started in Nov 2025 Mechanism of Action Antigen presentation Induction of T cell activation Attack Induction of tumor cell death *A key molecule in the activation of innate immunity and attracting attention in the field of cancer immunity Binding to cancer antigen Activation of antigen presenting cells via STING agonists DS3610 delivers STING* agonists to cancer cells via an antibody targeting a cancer antigen and activates antitumor immunity within the tumor microenvironment
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Today’s Topics for Our Future Innovation 82 ADCs DXd and New-concept • Leverage deep DXd ADC experience • Expanding value across tumor types • High clinical success probability Immuno- Oncology (IO) • Long-term remission via immune memory • DXd ADC and IO combinations with complementary mechanisms • Innovative approaches for cancers with high unmet needs Combination Strategy • Building the next standard of care • Enhancing portfolio leverage • Combining DXd ADCs and new MoA Deliver Durable Patient Benefit and Maximize Portfolio Value New Modalities • Establishing the technological advantages in multi-modality • Long-term growth options • Accelerating the innovation through partnership/collaboration Smart Lab / Open Innovation • Accelerating research productivity and scientific innovation through digital technology / external expertise ADC: antibody-drug conjugate, MoA: Mode of Action
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Daiichi Sankyo Takes Multi-Modality Strategy 83 Establishing proprietary technologies unique to Daiichi Sankyo and building a robust and competitive drug discovery platform across diverse modalities. Continuous Generation of Innovative Medicines that Transform the SOC DXd ADC Multispecific Antibody Mid-size Molecule (incl. TPD molecule) Nucleotide Gene Therapy Glycan etc. mPBD ADC ADC Platform New Modalities (beyond ADC) STING agonist ADC Neｗ Concept ADCs LNP-mRNA LNP: lipid nanoparticles, mPBD: modified pyrrolobenzodiazepine, SOC: Standard of Care, TPD: Targeted Protein Degradation
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Today’s Topics for Our Future Innovation 84 ADCs DXd and New-concept • Leverage deep DXd ADC experience • Expanding value across tumor types • High clinical success probability Immuno- Oncology (IO) • Long-term remission via immune memory • DXd ADC and IO combinations with complementary mechanisms • Innovative approaches for cancers with high unmet needs Combination Strategy • Building the next standard of care • Enhancing portfolio leverage • Combining DXd ADCs and new MoA Deliver Durable Patient Benefit and Maximize Portfolio Value New Modalities • Establishing the technological advantages in multi-modality • Long-term growth options • Accelerating the innovation through partnership/collaboration Smart Lab / Open Innovation • Accelerating research productivity and scientific innovation through digital technology / external expertise ADC: antibody-drug conjugate, MoA: Mode of Action
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Smart Lab: Enabling Competitive AI-driven Drug Discovery 85 Molecular Design with AI/ML What Smart Lab Delivers: 1. High-quality, Large-scale Data • Automation, Robotics & Integrated Data Platform 2. Smarter and Faster AI-learning Loop • Seamless data feedback to molecular design AI 3. Sustainable Competitive Advantage • Data & learning accumulate over time • Barriers to entry for competitors Accelerating and Enhancing Multi-Modality Drug Discovery Smart Lab (Data Product Factory) Learning Loop Smart Lab is the cornerstone of AI-driven drug design success. AI: artificial intelligence, ML: machine learning
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Launched Smart Research Lab in San Diego to Accelerate Innovation 86 Capabilities & Benefits Automate data generation to power AI-driven drug discovery Accelerate drug-candidate selection with 24/7 operations Unlock new insights through harmonized, high-quality data Enable researchers to focus on high-value science Facility & Team Development Integrated robotic automation for end-to-end workflows Foster close collaboration between researchers and engineers DS’s first dedicated drug discovery base in the U.S. Building a scalable foundation for sustained innovation and long-term growth. AI: artificial intelligence, ML: machine learning
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Daiichi Sankyo Research Institutes for External Collaboration 87 Daiichi Sankyo research activities are mainly based in Tokyo, where we have 10+ Research Laboratories RESEARCH INSTITUTE MUNICH (RIM) RESEARCH INSTITUTE BOSTON (RIB) DS RESEARCH LABORATORIES* TOKYO, JAPAN (SHINAGAWA, KASAI) DS TRCE** MUNICH, GERMANY * Wet laboratories In 2024 and 2025, we opened Daiichi Sankyo Research Institutes for external collaboration • to build a global network with academia/startup for innovative research • to drive ‘sponsored research’ supporting DS research strategy RESEARCH INSTITUTE SAN DIEGO (RISD)** Translational Research Center Europe
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× MODALITYBIOLOGY INCUBATE BLOOMING/ EMERGING CONCEPTS NOVEL MODALITY for established biology/target (e.g., drug delivery, brandnew technology) NEW BIOLOGY RESEARCH for DS’s modality (e.g., target identification, novel concept) We focus on early-stage Modality Development and Biology Research via Sponsored Research Programs Created with BioRender.com Research Institute Scouting Strategy Incubate either Novel Modality or New Biology through scientific discussion 88
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Science & Technology through Craftspersonship 89 ENHERTU® DATROWAY® TARLIGE® LIXIANA® EFIENT® • Have an insatiable passion to pursue new science & technology • Apply exceptional craftspersonship aiming for Innovation • Deliver unique value for patients At DS, we
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Crafting New Standards of Care 90
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Agenda Welcome Clinical Development Oncology Business Technology Research Q&A 1 2 3 4 5 6 91
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Contact address regarding this material Daiichi Sankyo Co., Ltd. Corporate Communications Department TEL: +81-3-6225-1125 Email: DaiichiSankyoIR_jp@daiichisankyo.com