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astellas Q1 YTD / FY2026 Financial Results Atsushi Kitamura Chief Financial Officer ( CFO ) Astellas Pharma Inc. August 5 , 2026 © 2026 ASTELLAS PHARMA INC . AND ITS AFFILIATES . Astellas Tsukuba Research Center
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2 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. In this material, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas Pharma. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this material is not intended to constitute an advertisement or medical advice. Information about investigational compounds in development does not imply established safety or efficacy of the compounds; there is no guarantee investigational compounds will receive regulatory approval or become commercially available for the uses being investigated. Cautionary Statement Regarding Forward-Looking Information
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3 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. Strategic Brands: PADCEV, IZERVAY, VYLOY, VEOZAH, XOSPATA. See slide 23 for overview of cost optimization BTC: Biliary tract cancer, chemo: Chemotherapy, G/GEJ: Gastric/gastroesophageal junction, GYN: Gynecologic cancers, MIBC: Muscle-invasive bladder cancer, NSCLC: Non-small cell lung cancer, PDAC: Pancreatic ductal adenocarcinoma, pembro: Pembrolizumab Financial Results Robust growth in Revenue (+27% YoY) and Core OP (+56% YoY) Core OP margin increased to 34.5% (+6.4ppt YoY) Driven by strong Strategic Brands growth and disciplined cost optimization, with favorable FX impacts Pipeline Progress PADCEV (MIBC): Approval (Europe, US)and filing (Japan, China), Phase 3 study initiated for bladder-sparing (EV-309) VYLOY (combo with pembro and chemo): Target enrollment achieved ahead of schedule in Phase 3 LUCERNA study Two new Phase 3 studies opened for recruitment (setidegrasib NSCLC, ASP2138 G/GEJ) New clinical data presented (setidegrasib BTC and GYN, ASP546C G/GEJ and PDAC) Q1 YTD/FY2026 Overview - Strong Q1 progress toward record-high full-year Revenue and Core OP -
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4 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. Agenda I II Q1 YTD/FY2026 Consolidated Financial Results Pipeline Progress
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5 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. (billion yen) Q1 YTD FY2025 Q1 YTD FY2026 Change Change (%) FX impact (YoY) FY2026 FCST* Revenue 505.8 640.9 +135.1 +26.7% +60.0 2,220.0 Cost of sales 94.8 122.7 +27.9 +29.4% +9.0 445.0 SG&A expenses 197.0 215.1 +18.1 +9.2% +19.6 800.0 US XTANDI co-promote fee 62.9 67.5 +4.6 +7.2% +6.3 216.0 SG&A excl. the above (SG&A ratio**) 134.1 26.5% 147.6 23.0% +13.5 -3.5ppt +10.1% +13.3 584.0 26.3% R&D expenses (R&D ratio) 71.7 14.2% 81.7 12.8% +10.0 -1.4ppt +14.0% +5.8 355.0 16.0% Core operating profit (Core OP margin) 142.3 28.1% 221.4 34.5% +79.1 +6.4ppt +55.6% +25.5 620.0 27.9% Amortisation of intangible assets 32.8 35.7 +2.9 +8.9% Other income 4.4 3.9 -0.5 -10.4% Other expenses 21.3 4.3 -17.0 -79.8% Operating profit 94.6 184.5 +89.9 +94.9% 395.0 Profit before tax 90.4 186.5 +96.1 +106.3% 385.0 Profit 68.4 141.8 +73.3 +107.2% 300.0 Q1 YTD/FY2026 Financial Results ＜Full basis＞ Great start to FY2026, delivering robust revenue and Core/Full OP growth fueled by favorable FX impacts *Disclosed in Apr 2026, **Excl. US XTANDI co-promote fee Actual exchange rates of Q1/FY2026: 159 yen/USD, 185 yen/EUR (Actual exchange rates of Q1/FY2025: 145 yen/USD, 164 yen/EUR) Exchange rate assumption of FY2026 FCST: 150 yen/USD, 180 yen/EUR
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6 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. (billion yen) Q1 YTD/FY2026 YoY Growth Strategic Brands Total 160.3 +48.3 (+43%) 75.5 +20.0 (+36%) 27.2 +11.2 (+70%) 21.1 +7.1 (+51%) 14.9 +5.3 (+55%) 21.6 +4.6 (+27%) 276.6 +43.6 (+19%) Q1 YTD/FY2026 Financial Results: Main Brands Continued strong momentum of Strategic Brands, driving overall revenue and profit growth VEOZAH: Approved as “VEOZA” in ex-US. 1L: First line, mUC: Metastatic urothelial cancer, MIBC: Muscle-invasive bladder cancer Strong momentum expected to continue throughout FY2026 PADCEV • Progress exceeding expectations, driven by strong penetration in global 1L mUC and US MIBC IZERVAY • Strong growth momentum driven by increased new patient starts, achieving market leadership in geographic atrophy VYLOY • Solid sales growth driven by continued increases in Claudin 18 testing rates VEOZAH • Continued growth, whilst holding a strong share position versus new competition in the US Progress in line with expectations, supported by favorable FX impact
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7 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. Q1 YTD/FY2026 Financial Results: Cost Items Cost Items YoY change Ratio to Revenue (yen) SG&A expenses (excl. US XTANDI co-promote fee) +10.1% (+0.1% excl. FX impact) SG&A ratio: 23.0% Held flat YoY excl. FX impact Increase in Strategic Brands-related investments for further growth SMT cost optimization: approx. -3 bil. (Efficiency benefits from Global Capability Center establishment, AI and digital capabilities, etc.) R&D expenses +14.0% (+5.9% excl. FX impact) R&D ratio: 12.8% YoY increase excl. FX impact: approx. +4 bil. Increase in pipeline clinical development costs: approx. +4 bil. (mainly setidegrasib, ASP2138 and ASP546C) Increase in Strategic Brands LCM clinical development costs: approx. +2 bil. (PADCEV and VYLOY) SMT cost optimization: approx. -3 bil. (Outsourcing costs reduction through insourcing development capabilities, incl. clinical trials, etc.) Expect increased investments from Q2 onward, aligned with Phase 3 initiation and patient enrollment progress *Excl. US XTANDI co-promote fee and FX impact SMT: Sustainable Margin Transformation, LCM: Lifecycle Management SG&A expenses* held flat YoY through disciplined management, ratio improved by 3.5ppt YoY Cost optimization (SMT): Approx. -8 billion Yen YoY (Total of SG&A expenses, R&D expenses, cost of sales)
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8 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. Agenda I II Q1 YTD/FY2026 Consolidated Financial Results Pipeline Progress
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9 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. Strategic Brands: Progress of Lifecycle Management Brand Indication FY2026 FY2027 Q1 (Apr-Jun) Q2 (Jul-Sep) Q3 (Oct-Dec) Q4 (Jan-Mar) Muscle-invasive bladder cancer (MIBC) Cis-ineligible (EV-303 study) Cis-eligible (EV-304 study) Bladder-sparing GA secondary to AMD Gastric and GEJ cancer (combo with pembro and chemo) VMS associated with menopause VMS in breast cancer women Japan: Regulatory decision Europe: Regulatory decision Phase 3 LUCERNA study data readout Phase 3 HIGHLIGHT 1 study data readout Japan: Filing China: Filing Regulatory activity Study progress Significant milestones achieved, notably PADCEV MIBC and VYLOY Phase 3 study VEOZAH: Approved as “VEOZA” in ex-US AMD: Age-related macular degeneration, chemo: Chemotherapy, Cis: Cisplatin, GA: Geographic atrophy, GEJ: Gastroesophageal junction, pembro: Pembrolizumab, VMS: Vasomotor symptoms US: Approved (Jul) Europe: Approved (Jun) Japan: Filed (May) China: Filed (May) Phase 3 EV-309 study initiated (Jun) China: Filed (Jul) STARLIGHT 3: Primary endpoint met (Apr) (Blue: Updates since the last financial results announcement) Target enrollment achieved (Jul)
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10 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. Pipeline Progress Pipeline progressing steadily in line with CSP2026, with two new Phase 3 studies opened for recruitment Phase 3/pivotal starts in FY26-27 Launch from FY29 onward PoC judgment in FY26-27 Pre-PoC PoC achieved In market Claudin 18.2-targeted therapies Prostate cancer Retinal disease ASP5541 ASP5834 VIR-5500 ASP2020 ASP1002 setidegrasib NSCLC ASP546C G/GEJ ASP7317 AT845 ASP2246 ASP2957 Phase 3/Pivotal ASP2138 PDAC ASP546C PDAC ASP2998 iADC SM ADC ADC TPD setidegrasib PDAC TPD TCE TCE TPD TCE mRNA Cell Cell Gene Gene Oncology Genitourinary Gastrointestinal Lung Other cancers Ophthalmology Neuromuscular & neurological disorders As of Jul 2026. Not exhaustively listed. (i)ADC: (immunostimulatory) Antibody-drug conjugate, ARVO: Association for Research in Vision and Ophthalmology, ASCO: American Society of Clinical Oncology, CSP: Corporate Strategic Plan, ESMO GI: European Society for Medical Oncology Gastrointestinal Cancers, G/GEJ: Gastric/gastroesophageal junction, mRNA: messenger RNA, NSCLC: Non-small cell lung cancer, PDAC: Pancreatic ductal adenocarcinoma, PoC: Proof of concept, SM: Small molecule, TCE: T-cell engager, TPD: Targeted protein degrader setidegrasib • Phase 3 study recruiting for NSCLC (NCT07566052) • Biliary tract and gynecologic cancers data presented at ESMO GI (Jul) ASP2138 • Phase 3 study recruiting for G/GEJ (NCT07673887) ASP546C • China Phase 2 data presented at ASCO (Jun) ASP7317 • Phase 1b study data presented at ARVO (May) Major progress ASP2138 G/GEJ TCE Phase 3 recruiting Phase 3 recruiting
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11 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. Current status Overview Global Phase 1b/2 study ongoing (NCT07488676, sponsored by Astellas) Phase 3 study in China in G/GEJA ongoing (sponsored by Evopoint) Latest data Progress in ASP546C Antibody-drug conjugate (ADC) targeting CLDN18.2 Payload: Proprietary topoisomerase I inhibitor, Drug-to-antibody ratio: 8 Linker: MediLink’s TMALIN (Tumor Microenvironment Activable LINker) technology Fast Track designation by FDA granted (gastric cancer) Exclusive license to develop and commercialize worldwide, excluding China’s mainland, Hong Kong, Macao and Taiwan region Clinical data from China Phase 2 study presented at ASCO 2026 <Efficacy in 2L+ PDAC (CLDN18.2 ≥5%) @ 3mg/kg, mono> <Efficacy in 2L+ G/GEJA (CLDN18.2 ≥20%) @ 3mg/kg, mono> *Unconfirmed, ASCO: American Society of Clinical Oncology, 2L+: Second or later line, CLDN18.2: Claudin 18.2, DCR: Disease control rate, FDA: Food and Drug Administration, G/GEJA: Gastric/gastroesophageal junction adenocarcinoma, Mono: Monotherapy, ORR: Objective response rate, mOS: Median overall survival, PDAC: Pancreatic ductal adenocarcinoma, mPFS: Median progression-free survival, TOP1i: Topoisomerase I inhibitor China Phase 2 study demonstrated anti-tumor activities in G/GEJA and PDAC ALL (n=26) ≥2 prior lines therapy (n=23) ORR 65.4% 73.9% DCR 84.6% 87.0% mPFS 5.7m 6.8m mOS 11.7m 11.9m ALL (n=30) 1 prior line therapy (n=13) Prior TOP1i therapy (n=13) ORR* 26.7% 46.2% 30.8% DCR* 83.3% 100.0% 84.6% mPFS 4.1m 4.4m 5.2m mOS 10.0m 10.1m 10.0m
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12 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. Progress in setidegrasib Clinical data in patients with biliary tract (BTC) and gynecologic cancers (GYN) from Phase 1 study presented at ESMO GI 2026 Anti-tumor activities observed; which was most notable in patients with 2-4L BTC KRAS G12D mutations occur in ~9% of patients with BTC and ~5% with GYN1,2 Latest data Patients whose response was not determined are excluded from the plot (n = 1 each for BTC and GYN). a Defined as patients with BOR of CR/PR with confirmation; b Defined as patients with BOR of CR, PR, or SD, or non-CR/non- PD for patients with no measurable disease at baseline per RECIST v1.1. BTC (n=14) BTC (1-3 prior LOT) (n=9) GYN (n=6) ORRa, n(%) 5 (35.7) 4 (44.4) 3 (50.0) DCRb, n(%) 13 (92.9) - 5 (83.3) Best change from baseline (%) BTC BTC (1-3 prior LOT) GYN mPFS 4.8m 7.1m 4.2m Months BTC (1-3 prior LOT) 1. Iida K et al. ESMO Open. 2025;10(6):105306. 2. Son J et al. Clin Cancer Res. 2024;30(14): 2986-95. ESMO GI: European Society for Medical Oncology Gastrointestinal Cancers, 2L: Second line, 4L: Fourth line, BOR: Best overall response, CR: Complete response, DCR: Disease control rate, KRAS: Kirsten rat sarcoma viral oncogene homologue, LOT: Line of treatment, ORR: Objective response rate, PD: Progressive disease, mPFS: Median progression-free survival, PR: Partial response, SD: Stable disease Anti-tumor activities observed in biliary tract and gynecologic cancers
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13 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. Expanding Primary Focus: From “Targeted Protein Degradation” to a Broader “Induced Proximity” Platform • Many disease-driving proteins remain difficult to target with conventional approaches, creating significant room for innovation • Induced Proximity modalities are designed to overcome barriers of traditional treatments by creating new connections inside the cell that help remove harmful proteins and regulate disease processes Primary Focus Targeted Protein Degradation Induced Proximity Biology Inhibit signal transduction with target protein degradation Regulation of protein function with induced proximity Modality Disease Solid tumors (KRAS mutation) Potential to extend beyond solid tumors Protein degraders Molecular Glues Protein degraders KRAS: Kirsten rat sarcoma viral oncogene homologue, RIPTACs：Regulated induced proximity targeting chimeras, TPD: Targeted protein degradation, Ub: Ubiquitin Protein of interest (POI) E3 ligase RIPTACs POI Effector protein (EP) Induced Proximity unlocks differentiated pipeline potential in hard-to-treat cancers with long-term growth opportunity B: Biology, D: Disease, M: Modality
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14 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. Key Takeaways Great start to FY2026, building strong momentum toward CSP2026 Robust Q1 Revenue and Profit Growth Solid Pipeline Progress • Strong Strategic Brands growth Driving robust revenue and profit growth, strong momentum expected to continue throughout FY2026 • Solid progress of disciplined cost optimization SG&A expenses held flat YoY * through disciplined management • Significant milestones achieved in LCM PADCEV (MIBC): Multiple approvals and filings, Phase 3 EV-309 study initiated for bladder- sparing VYLOY: Target enrollment achieved in Phase 3 LUCERNA study • Phase 3 studies opened for recruitment setidegrasib NSCLC, ASP2138 G/GEJ *Excl. US XTANDI co-promote fee and FX impact CSP: Corporate Strategic Plan, G/GEJ: Gastric/gastroesophageal junction, LCM: Lifecycle management, MIBC: Muscle-invasive bladder cancer, NSCLC: Non-small cell lung cancer LINK to CSP2026 presentation material
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©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. Appendix ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES.
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16 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. Peak Sales: 400-500B Yen ($2.7-3.3B) Peak Sales: 100-200B Yen ($0.7-1.3B) Peak Sales: 100-200B Yen ($0.7-1.3B) Peak Sales: 200-400B Yen ($1.3-2.7B) Peak Sales: 150-250B Yen ($1.0-1.7B) Oncology Ophthalmology Women’s Health Oncology Oncology Strategic Brands: Potential Peak Sales (as of Jul 2026) Converted at 1 USD = 150 Yen. PADCEV peak sales are disclosed as “in-market sales,” not Astellas revenue. Sales for the Americas are calculated based on sales booked by our partner.
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17 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. Capital Allocation Policy Maintain Gross Debt*/EBITDA** of 1.0x to 1.5x to keep adequate debt capacity for potential large-scale investment 21 3Top priority is investment for business growth Raise dividend level aligned with profit / cashflow plan and actual performance Flexibly execute share buyback by excess cash FY2026 is forecast. *Gross Debt: Interest-bearing debt + Lease liabilities + Retirement benefit liabilities, etc, **EBITDA: Profit before tax + Amortisation of Intangible Assets (incl. software, etc.) + Depreciation (PP&E) + Interest expenses + Other expenses 14 16 22 24 25 25 25 26 27 30 32 34 36 38 40 42 50 60 70 74 78 80 0 20 40 60 80 100 FY05 FY06 FY07 FY08 FY09 FY10 FY11 FY12 FY13 FY14 FY15 FY16 FY17 FY18 FY19 FY20 FY21 FY22 FY23 FY24 FY25 FY26 FY27 FY28 FY29 FY30 Dividends Trend Dividends (Yen) For illustrative purposes only Minimum annual 2 Yen dividend increase throughout CSP2026 period
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18 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. Q1 YTD/FY2026 Actual: FX Rate Currency Q1 YTD/FY2025 Q1 YTD/FY2026 Change USD 145 yen 159 yen +15 yen EUR 164 yen 185 yen +21 yen Average rate for the period <Impact of exchange rate on financial results> Revenue: +60.0 billion yen Core OP: +25.5 billion yen
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19 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. FY2026 Forecast: FX Rate & FX Sensitivity Currency Average rate 1 yen depreciation from assumption Revenue Core OP USD Approx. +8.1 bil. yen Approx. +2.3 bil. yen EUR Approx. +3.8 bil. yen Approx. +1.7 bil. yen Exchange rate Average for the period FY2025 FY2026 FCST Change USD 151 yen 150 yen -1 yen EUR 175 yen 180 yen +5 yen Estimated FX sensitivity FY2026 forecasts by 1 yen depreciation
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20 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. Balance Sheet & Cash Flow Highlights (billion yen) Mar 31, 2026 Jun 30, 2026 Total assets 3,567.0 3,692.5 Cash and cash equivalents 281.6 244.7 Total equity attributable to owners of the parent Ratio of equity attributable to owners of the parent to total assets (%) 1,829.0 51.3% 1,942.7 52.6% (billion yen) Q1 YTD/FY2025 Q1 YTD/FY2026 Cash flows from operating activities 54.8 86.5 Cash flows from investing activities -16.7 -69.2 Free cash flows 38.1 17.2 Cash flows from financing activities -11.0 -52.9 Increase/decrease in short-term borrowings and commercial papers 65.6 29.9 Redemption of bonds and repayments of long-term borrowings -6.7 -6.7 Dividends paid -66.2 -69.9
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21 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. Balance of Bonds and Borrowings Highlights (billion yen) Mar 31, 2026 Jun 30, 2026 Balance of bonds and borrowings 566.0 589.9 Non-current liabilities Bonds Long-term borrowings 320.0 220.0 100.0 320.0 220.0 100.0 Current liabilities Commercial papers Current portion of long-term borrowings Current portion of bonds 246.0 - 146.0 100.0 269.9 300 139.9 100.0
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22 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. Main Intangible Assets (as of Jun 30, 2026) Bil. yen Foreign currency** AT845 11.8 $73M Gene therapy related technology* 60.7 $373M VEOZAH** 85.2 €461M VYLOY** 53.3 €410M IZERVAY （US） 561.8 $3,456M IZERVAY (Ex-US） 51.4 $316M ASP7317 28.0 $172M VIR-5500 39.0 $240M ASP546C 23.0 n/a VEOZAH: Approved as “VEOZA” in ex-US *Acquired during the acquisition of Audentes (now Astellas Gene Therapies) **VEOZAH, VYLOY: foreign currency is a reference value based on the currency at the time of acquisition of the intangible asset
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23 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. Disciplined Cost Optimization 65B Yen FY24/25 Achieved through SMT Sustainable Margin Transformation (SMT) Additional Initiatives 40B Yen FY26 FY27 45B Yen Recurring cost optimization target 200B Yen over CSP2026 period Reinvest for pipeline growth and sustain elevated profitability • Build critical in-house capability to reduce outsourcing • Efficiency benefits from Global Capability Center establishment, AI and digital capabilities • Cost optimization by managing brand life cycle for XTANDI and mirabegron • Evolve operating model to drive agility and productivity Initiatives to drive cost optimization Recurring Cost Optimization Target (FY26-30) 200B Yen ($1.3B) Converted at 1 USD = 150 Yen.
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24 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. Prostate Cancer Phase XTANDI (enzalutamide) In market ASP5541 VIR-5500 Urothelial Cancer Phase PADCEV (enfortumab vedotin) mUC, Cisplatin-ineligible/eligible MIBC In market enfortumab vedotin Bladder-sparing MIBC Upper GI and Pancreatic Cancer Phase VYLOY (zolbetuximab) Gastric and GEJ cancer In market zolbetuximab Gastric and GEJ cancer, combo with pembrolizumab and chemotherapy ASP2138 Gastric, GEJ, pancreatic cancer ASP546C setidegrasib (ASP3082) PDAC Acute Myeloid Leukemia Phase XOSPATA (gilteritinib) AML In market gilteritinib Earlier-stage AML, pediatric use gilteritinib Newly diagnosed AML, HIC-ineligible Solid Tumors Phase setidegrasib (ASP3082) NSCLC gilteritinib ALK-positive NSCLC ASP1002 ASP5834 ASP2998 Ophthalmology Phase IZERVAY (avacincaptad pegol) GA secondary to AMD In market ASP7317 GA secondary to AMD Vasomotor Symptoms (VMS) Phase VEOZAH (fezolinetant) VMS due to menopause In market fezolinetant VMS due to menopause: China, Japan VMS in breast cancer women Neuromuscular & Neurological Phase AT845 Pompe disease ASP2957 X-linked myotubular myopathy ASP2246 Motor dysfunction associated with ischemic stroke CTN open (Japan) Our Pipeline As of Jul 2026. Not exhaustively listed ALK: Anaplastic lymphoma kinase, AMD: Age-related macular degeneration, AML: Acute myeloid leukemia, CTN: Clinical Trial Notification, GA: Geographic atrophy, GEJ: Gastroesophageal junction, GI: Gastrointestinal, HIC: High-intensity chemotherapy, MIBC: Muscle-invasive bladder cancer, mUC: Metastatic urothelial carcinoma, NSCLC: Non-small cell lung cancer, PDAC: Pancreatic ductal adenocarcinoma 1 1 1 1 1 2 3 3 1 1 3 2 3 1 1 2 1 3
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25 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. Progress in Overall Pipeline Phase 1 Entry to Approval Since the Last Financial Results Announcement Phase 1 Entry Phase 2 Entry Phase 3 Entry Filing Approval Phase 1 entry and Phase transition are defined by first subject dosed. Filing is defined as submission of application to health authorities. Discontinuation is defined by the decision of company decision body. enfortumab vedotin Muscle-invasive bladder cancer who are eligible for cisplatin-containing chemotherapy: Japan Muscle-invasive bladder cancer: China avacincaptad pegol GA secondary to AMD: China enfortumab vedotin Bladder-sparing muscle-invasive bladder cancer enfortumab vedotin Muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy: Europe Muscle-invasive bladder cancer who are eligible for cisplatin-containing chemotherapy: US
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26 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. enfortumab vedotin (EV) (1/4): Nectin-4 Targeted ADC Number of Eligible Patients 1L: First line, 2L+: Second or later line, ADC: Antibody-drug conjugate, Cis: Cisplatin, MIBC: Muscle-invasive bladder cancer, mUC: Metastatic urothelial cancer, Pembro: Pembrolizumab Patient segment Pivotal study (EV regimen) Number of eligible patients* MIBC** Cis-ineligible EV-303 (combo w/ Pembro) 38,000 Cis-eligible EV-304 (combo w/ Pembro) 59,000 Bladder-sparing EV-309 (combo w/ Pembro) 34,000 1L mUC EV-302 (combo w/ Pembro) 115,000 2L+ mUC (platinum & PD-1/L1 inhibitor pretreated) EV-301 (monotherapy) 49,000 *US, Germany, France, Italy, Spain, UK, Japan, China (based on internal estimates) **MIBC patients intended for RC (EV-303/EV-304) and MIBC patients ineligible for RC or not intended for RC (excluding partial cystectomy or no treatment)
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27 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. enfortumab vedotin (EV) (2/4): Clinical Studies P3: EV-303 /KEYNOTE-905 NCT03924895 MIBC, Cis-ineligible; Pembro +/- EV (perioperative) + RC vs. RC alone n=595 sBLA approved in US in Nov 2025 sNDA submitted in Japan in Jan 2026 Type II variation approved in Europe in Jun 2026 sBLA accepted in China in Jul 2026 P3: EV-304 /KEYNOTE-B15 NCT04700124 MIBC, Cis-eligible; EV + Pembro (perioperative) + RC vs. Chemo (neoadjuvant) + RC n=808 Type II variation accepted in Europe in Mar 2026 sNDA submitted in Japan in May 2026 sBLA accepted in China in Jul 2026 sBLA approved in US in Jul 2026 P3: EV-309 NCT07566156 MIBC, ineligible or refused cystectomy; EV + Pembro vs. Concurrent CRT n=390 FSD: Jun 2026 P2: EV-209 NCT07475806 MIBC, eligible but do not undergo cystectomy; EV + Pembro (single-arm study) n=240 FSD: Apr 2026 Chemo: Chemotherapy, Cis: Cisplatin, CRT: Chemoradiotherapy, FSD: First subject dosed, MIBC: Muscle-invasive bladder cancer, mUC: Metastatic urothelial cancer, Pembro: Pembrolizumab, RC: Radical cystectomy, sBLA: Supplemental Biologics License Application , sNDA: Supplemental New Drug Application (Blue: Updates since the last financial results announcement)
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28 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. enfortumab vedotin (EV) (3/4): Study Data by Disease Stage Disease stage MIBC mUC Surgery eligible Previously untreated (first line) PD-1/L1 inhibitor pretreated Cis- eligible Cis- ineligible Platinum eligible Cis-ineligible Platinum naïve & Cis-ineligible Platinum pretreated Study phase Phase 3 Phase 3 Phase 3 Phase 1b/2 Phase 1b/2 Phase 2 Phase 2 Phase 3 Study No. KN-B15 / EV-304 KN-905 / EV-303 EV-302 EV-103 Cohort K EV-103 Cohort A & Others EV-201 Cohort 2 EV-201 Cohort 1 EV-301 No. of subjects 808 (2 arms) 595 (3 arms) 886 76 73 45 89 125 608 (2 arms) EV regimen Combo w/ Pembro (perioperative) Combo w/ Pembro (perioperative) Combo w/ Pembro Combo w/ Pembro Mono Combo w/ Pembro Mono Mono Mono Control Chemo (neoadjuvant) SoC Chemo n/a n/a n/a n/a n/a Chemo Primary endpoint EFS: HR 0.53* EFS: HR 0.40* PFS: HR 0.48** OS: HR 0.51** ORR 64% (CR 11%) ORR 45% (CR 4%) ORR 73%** (CR 16%**) ORR 51%** (CR 22%**) ORR 44% (CR 12%) OS HR 0.70* OS HR 0.65* (NR vs. NR) HR 0.50* (NR vs. 41.7 mos) HR 0.51** (33.8 mos vs. 15.9 mos) n/a (21.7 mos) (26.1 mos**) (14.7 mos) (12.4 mos **) HR 0.70* (12.9 mos vs.9.0 mos) EFS (MIBC)/ PFS (mUC) HR 0.53* (NR vs. 48.5 mos) HR 0.40* (NR vs. 15.7 mos) HR 0.48** (12.5 mos vs. 6.3 mos) n/a (8.2 mos) (12.7 mos**) (5.8 mos) (5.8 mos) HR 0.62* (5.6 mos vs.3.7 mos) pCR (MIBC)/ ORR (mUC) 55.8% vs. 32.5%* 57.1% vs. 8.6%* 67.5% vs. 44.2%** (CR 30.4% vs. 14.5%) 64% (CR 11%) 45% (CR 4%) 73%** (CR 16%**) 52% (CR 20%) 44% (CR 12%) 41% vs.18%* (CR 4.9% vs.2.7%) DoR n/a n/a 23.3 mos vs. 7.0 mos** n/a 13.2 mos 22.1 mos** 13.8 mos** 7.6 mos 7.4 mos vs. 8.1 mos* : Data obtained, *: Prespecified interim analysis, **: Updated data Early stage Late stage Chemo: Chemotherapy, Cis: Cisplatin, (p)CR: (Pathological) Complete response, DoR: Duration of response, EFS: Event-free survival, HR: Hazard ratio, MIBC: Muscle-invasive bladder cancer, mono: Monotherapy, mUC: Metastatic Urothelial cancer, ORR: Objective response rate, OS: Overall survival, Pembro: Pembrolizumab, PFS: Progression-free survival, SoC: Standard of care
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29 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. enfortumab vedotin (EV) (4/4): Development for Muscle-Invasive Bladder Cancer (MIBC) 3) Phase 3 study in MIBC patients who are ineligible or refused cystectomy (EV-309): EV + Pembro vs. Concurrent CRT Primary endpoint: BI-EFS assessed by BICR, OS n=390, randomized 1:1 2) Phase 3 study in Cis-eligible MIBC (KEYNOTE-B15/EV-304): Perioperative EV + Pembro vs. Neoadjuvant chemo Arm A Arm B EV + Pembro [4 cycles] Cis + Gem (SoC) [4 cycles] Observation (SoC) pCR Cystectomy Endpoints: Primary: EFS Key secondary: OS, pCR n=808, randomized 1:1 EFS and OS span the duration of the trial EV + Pembro [5 cycles] Pembro [8 cycles] 1) Phase 3 study in Cis-ineligible MIBC (KEYNOTE-905/EV-303): Perioperative EV + Pembro vs. Cystectomy alone Arm A Arm C Arm B Pembro [3 cycles] Pembro [14 cycles] Direct to cystectomy (SoC) Observation (SoC) EV + Pembro [3 cycles] pCR Cystectomy Endpoints: Primary: EFS Key secondary: OS, pCR n=595, randomized 1:1:1 Arm C added to the Merck- sponsored KEYNOTE-905 study EV + Pembro [6 cycles] Pembro [8 cycles] EFS and OS span the duration of the trial 1 cycle = 21 days BI-EFS: Bladder-intact Event-free survival, chemo: Chemotherapy, Cis: Cisplatin, CRT: Chemoradiotherapy, EFS: Event-free survival, Gem: Gemcitabine, mono: Monotherapy, pCR: Pathological complete response, Pembro: Pembrolizumab, OS: Overall survival, SoC: Standard of care EV＋Pembro ［9 cycles］ Pembro ［8 cycles］ Concurrent Chemoradiotherapy Arm A Arm B (Blue: Updates since the last financial results announcement)
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30 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. zolbetuximab: anti-Claudin 18.2 Monoclonal Antibody Gastric and GEJ adenocarcinoma P3: LUCERNA NCT06901531 First line, combo with pembro and chemo vs. placebo + pembro + chemo (CAPOX or mFOLFOX6), CLDN18.2-high* and CPS ≥1 n=500 Target enrollment achieved P2: ILUSTRO NCT03505320 Cohort 1: Third or later line, monotherapy Cohort 2: First line, combo with mFOLFOX6 Cohort 3: Third or later line, combo with Pembro Cohort 4: First line, combo with mFOLFOX6 and nivolumab Cohort 5: Perioperative, combo with FLOT n=143 Enrollment completed 1. ASCO GI 2026, 2. N Engl J Med. 2024;391:1159-62, 3. Lancet. 2021;398:27-40. *CLDN18.2 positivity is defined as ≥75% of tumor cells demonstrating moderate to strong membranous CLDN18 immunohistochemical staining, chemo: Chemotherapy, CPS: Combined positive score, FLOT: Fluorouracil, leucovorin, oxaliplatin and docetaxel, FSD: First subject dosed, GEJ: Gastroesophageal junction, mFOLFOX6: 5-FU, leucovorin and oxaliplatin, mPFS: Median progression-free survival, pembro: Pembrolizumab Latest Data1 Phase 2 ILUSTRO study Cohort 4B (zolbetuximab + nivolumab + mFOLFOX6; moderate-to-strong CLDN18.2 staining in ≥50% of tumor cells) mPFS = 14.8 months overall 18.0 months in CLDN18.2-high 23.6 months in CLDN18.2-high and CPS ≥1 (Ref) mPFS in zolbetuximab + Chemo: 9.2 months2 nivolumab + Chemo: 7.7 months (all) / 7.5 months (CPS ≥1)3 mPFS = 23.6 months mPFS = 12.1 months CLDN18.2-high population (moderate-to-strong CLDN18.2 staining in ≥75% of tumor cells) Overview Claudin (CLDN) is a major structural component of tight junctions and seals intercellular space in epithelial sheets 38% of patients had CLDN18.2-positive tumors* in SPOTLIGHT and GLOW studies for gastric and GEJ adenocarcinoma (Blue: Updates since the last financial results announcement)
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31 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. fezolinetant: NK3 Receptor Antagonist 1: DelveInsight, Epidemiology Forecast, Jun 2018. 2: Data Source - IMS NPA (2000-2016), IMS NSP (2000-2016). (3 HTs and SSRI) NAMS 2015 Position Statement DB: Double-blind, FSD: First subject dosed, HRT: Hormone replacement therapy, NK3: Neurokinin 3, QoL: Quality of life, VMS: Vasomotor symptoms VMS has a significant negative impact on QoL Physical symptoms include hot flashes and night sweats, which can impact sleep. Physical symptoms may lead to emotional impact including embarrassment, irritability, anxiety, and sadness Symptoms have a negative impact on multiple aspects of everyday life1 Women’s Health Initiative (WHI) Study2 Initial data analyses showed an association between chronic HRT use and increased risk of cardiovascular disease and breast cancer Since WHI’s findings, use of HRT has dropped Although subsequent analysis of the WHI data have demonstrated that HRT is safe and effective when initiated in the appropriate patient in the appropriate manner (i.e. right time, formulation, dose and duration), prescriptions have not rebounded, leaving some women with minimal options to satisfactorily manage their VMS China VMS associated with menopause Japan P3: STARLIGHT 2 NCT06206408 Mild to severe VMS associated with menopause; 8 weeks: DB, 2 doses vs. placebo (1:1:1) n=410 Primary endpoint met P3: STARLIGHT 3 NCT06206421 VMS associated with menopause; 52 weeks: DB, vs. placebo (1:1) n=277 Primary endpoint met China P2 NCT06812754 Moderate to severe VMS associated with menopause; 12 weeks: DB, 45 mg vs. placebo (1:1) n=150 Primary endpoint met P3: HIGHLIGHT 1 NCT06440967 Moderate to severe VMS associated with adjuvant endocrine therapy for breast cancer; 52 weeks (efficacy endpoints at 4 and 12 weeks): DB, vs. placebo (1:1) n=540 FSD: Aug 2024 VMS in breast cancer women receiving adjuvant endocrine therapy (Blue: Updates since the last financial results announcement)
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32 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. gilteritinib: FLT3 Inhibitor FLT3 mut+ AML Low-intensity chemo Chemo consolidation Salvage therapyTransplant ADMIRAL VICEROY Maintenance GOSSAMERHigh- intensity induction chemo Maintenance MORPHO PASHA (HOVON) PrE0905 (PrECOG) Launched Newly diagnosed (HIC-eligible) P3: PASHA (HOVON) NCT04027309 Combo with high intensity chemo gilteritinib vs. midostaurin (1:1) n=766 Primary endpoint not met P2: PrE0905 (PrECOG) NCT03836209 n=181 Topline results presented at ASH 2024 (Sponsor: PrECOG, LLC.) Newly diagnosed (HIC-ineligible) P1/2: VICEROY NCT05520567 Combo with venetoclax and azacitidine n=70 FSD: Jan 2023 ALK: Anaplastic lymphoma kinase, AML: Acute myeloid leukemia, ASH: American Society of Hematology, Chemo: Chemotherapy, FLT3 mut+: FLT3 mutation positive, FSD: First subject dosed, HIC: High-intensity chemotherapy, HOVON: The Haemato Oncology Foundation for Adults in the Netherlands ALK-positive P1 NCT07140016 Monotherapy n=40 FSD: Oct 2025 Acute myeloid leukemia Non-small cell lung cancer
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33 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. 1. npj Precis Oncol. 2022;6:91, 2. N Engl J Med 2026 Mar; doi: 10.1056/NEJMoa2600752. 1L: First line, 2L+: Second or later line, ASCO GI: American Society of Clinical Oncology Gastrointestinal Cancers Symposium, DCR: Disease control rate, ELCC: European Lung Cancer Conference, KRAS: Kirsten rat sarcoma viral oncogene homologue, mFOLFIRINOX: Leucovorin, fluorouracil, irinotecan and oxaliplatin, NALIRIFOX: Leucovorin, fluorouracil, liposomal irinotecan and oxaliplatin, NEJM: The New England Journal of Medicine, ORR: Objective response rate, OS: Overall survival, PoC: Proof of concept setidegrasib: KRAS G12D Degrader Pancreatic ductal adenocarcinoma (PDAC)Overview Non-small cell lung cancer (NSCLC) Phase 3 study in 1L PDAC ongoing (NCT07409272) Primary analysis anticipated: FY2029 (interim analysis) PoC achieved 1L data presented at ASCO GI 2026 Phase 3 study in 2L+ NSCLC recruiting (NCT07566052) Primary analysis anticipated: FY2028 setidegrasib QW + mFOLFIRINOX or NALIRIFOX Placebo + mFOLFIRINOX or NALIRIFOX N=614 R (1:1) Primary endpoint: OS Rate of patients with KRAS G12D mutation: ~40% in PDAC, ~5% in NSCLC1 Phase 1 study ongoing (NCT05382559) Data generation in progress to support development in other KRAS G12D mutant cancers setidegrasib QW Docetaxel N=356 R (1:1) Primary endpoint: PFS, OS Response rates ORR, n (%) 7/12 (58.3) DCR, n (%) 10/12 (83.3) PoC achieved 2L+ monotherapy data presented at ELCC 2026 and NEJM2 ORR=37.5% in 2/3L (Blue: Updates since the last financial results announcement)
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34 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. T-cell engager targeting CLDN18.2 and CD3 with SC route Target disease: Gastric/GEJ (G/GEJ) adenocarcinoma and PDAC Rate of CLDN18.2-positive patients*: ~70% in G/GEJ adenocarcinoma1 and ~60% in PDAC2 *Represents % of patients with any level of CLDN18.2+ staining (≥1%; cf. ≥75% for VYLOY), 1. Gastric Cancer. 2024;27:1058, 2. Int J Cancer. 2013;134:731, 3. European Society for Medical Oncology (ESMO) 2025 1L: First line, 2L: Second line, CLDN: Claudin, DCR: Disease control rate, G/GEJ: Gastric/Gastroesophageal junction, mFOLFOX6: 5-FU, leucovorin and oxaliplatin, ORR: Objective response rate, PDAC: Pancreatic ductal adenocarcinoma, Pembro: Pembrolizumab, PoC: Proof of concept, SC: Subcutaneous, SoC: Standard of care Current statusOverview Latest data3 Phase 3 study in 1L G/GEJ recruiting (NCT07673887) Patients with low-intermediate CLDN18.2 expression Primary analysis anticipated: FY2029 Phase 1 studies ongoing (NCT05365581, NCT07024615) PoC achieved in G/GEJ adenocarcinoma ASP2138 SC demonstrated clinically meaningful antitumor activity in combination with SoC in G/GEJ adenocarcinoma 1L: ORR** = 62.5% (15/24); 12-week DCR = 100.0% (6/6) 2L: ORR** = 37.5% (9/24); 12-week DCR = 60.0% (9/15) **unconfirmed ORR, at 2,000 μg Responses were observed in patients with both low- intermediate and high CLDN18.2 expression levels 1L G/GEJ adenocarcinoma; ASP2138 SC Q2W + Pembro + mFOLFOX6 Best change from baseline (%) ASP2138: T-cell Engager Targeting Claudin 18.2 and CD3 ASP2138 + pembro + (mFOLFOX6 or CAPOX) Placebo + (pembro or placebo) (mFOLFOX6 or CAPOX) N=570 R (1:1) Primary endpoint: OS, PFS (Blue: Updates since the last financial results announcement)
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35 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. Portfolio of Claudin 18.2-Targeted Therapies VYLOY ASP2138 ASP546C Modality • Monoclonal antibody • T-cell engager (Bispecific antibody ) • Antibody-drug conjugate Mode of action • Immune cell-mediated • Immune cell-mediated • Direct action of payload Clinical data • Prolonged survival in combo w/ Chemo (SPOTLIGHT/GLOW) • Evaluating combo w/ Chemo + CPI (LUCERNA) • Evaluating combo w/ SoC regimens as well as monotherapy in G/GEJ cancer and PDAC • Promising antitumor activity with monotherapy in G/GEJ cancer and PDAC with manageable tolerability Future potential • SoC for CLDN18.2+ high* G/GEJ cancer: ~38% of patients • Enhanced immune response • Expansion to low-intermediate CLDN18.2+ population in 1L G/GEJ cancer: ~35% of patients • Ease of use with SC route • “SoC Chemo-free” regimen • All CLDN18.2+ population eligible (G/GEJ cancer and PDAC) • Expansion to other CLDN18.2+ tumor types Aim to address broader patient population with multiple differentiated assets *VYLOY: CLDN18.2 positivity is defined as ≥75% of tumor cells demonstrating moderate to strong membranous CLDN18 immunohistochemical staining 1L: First line, Chemo: Chemotherapy, CLDN18.2: Claudin 18.2, CPI: Checkpoint inhibitor, G/GEJ: Gastric/gastroesophageal junction, PDAC: Pancreatic ductal adenocarcinoma, SC: Subcutaneous, SoC: Standard of care
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36 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. Transplantation of retinal pigment epithelial cells aiming to maintain and restore visual functions Target disease: GA secondary to AMD Estimated Number of patients: ~5 million worldwide1 Approved treatment: Complement inhibitors Slow disease progression Current status Overview 1. Retina. 2017;37:819-835 AMD: Age-related macular degeneration, BCVA: Best corrected visual acuity, GA: Geographic atrophy, IOI: Intraocular inflammation, PoC: Proof of concept Phase 1b study ongoing (NCT03178149) PoC achieved in patients with severe vision impairment due to GA Latest data ASP7317: Retinal Pigment Epithelial Cell Study eye Fellow eye <Mean BCVA change over time> (Cohort 2 and 2b: SVI patients, medium dose, n=3-5*; BCVA: 15-37 letters (≥20/500 to ≤20/200)) Initial data from Phase 1b study presented at Association for Research in Vision and Ophthalmology (ARVO) 2026 Well-tolerated with no IOI events and no evidence for ASP7317 cell rejection or graft failure, and no tumors A possible trend for improving BCVA in SVI (severe vision impairment) patients following ASP7317 transplantation Mean (SE) Change from Baseline in BCVA (letters) (Blue: Updates since the last financial results announcement) *n=5 at 26 weeks, n=3 at 52 weeks
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37 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. Recombinant AAV8 continuously expressing hGAA gene specially in muscle Target disease: Pompe disease Estimated incidence: 1 in ~40,0001 Standard of care: Enzyme replacement therapy (ERT) Chronic, repeated infusions every 2 weeks Secondary disease progression after 2-3 years on ERT2,3,4 Substantial economic burden with high rates of healthcare resource utilization5 Current status Phase 1/2 FORTIS study ongoing (NCT04174105) RMAT designation granted by FDA in Feb 2025 PoC analysis ongoing FORTIS study data cut off: Jul 22, 2025, 1. NORD (National Organization for Rare Disorders) at https://rarediseases.org/rare-diseases/pompe-disease/, 2. Neuromuscul Disord. 2021;31:91-100,, 3. J Neurol. 2021;268:2482-2492, 4. Mol Genet Metab. 2012;106:301-309, 5. Mol Genet Metab. 2025;144:Article 108958. AAV: Adeno-associated virus, FDA: Food and Drug Administration, hGAA: Human acid alpha-glucosidase, PoC: Proof of concept, RMAT: Regenerative Medicine Advanced Therapy AAV8 capsid GAA gene Follow-up data from Phase 1/2 FORTIS study presented at WORLDSymposium 2026 Of the 6 participants with ≥1 year follow-up, 5 remained off ERT between 1 and >3.5 years Weeks relative to dosing Change from baseline in FVC,% predicted (upright) Change in forced vital capacity Change from baseline in 6MWT,% predicted Weeks relative to dosing Change in 6-minute walk test Overview Latest data AT845: AAV8 Based Gene Therapy Expressing hGAA Gene
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38 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES. VIR-5500: Dual-masked CD3 T-cell Engager Targeting PSMA PSA50 PSA decline of 50%-100% from baseline PSA90 PSA decline of 90%-100% from baseline PSA99 PSA decline of 99%-100% from baseline: , : , : ASCO GU: American Society of Clinical Oncology Genitourinary Cancers Symposium, CRS: Cytokine release syndrome, DCR: Disease control rate, DLT: dose limiting toxicity, mCRPC: metastatic Castration-Resistant Prostate Cancer, ORR: Objective response rate, PSA: Prostate-specific antigen, PSMA: Prostate-Specific Membrane Antigen, RECIST: Response Evaluation Criteria in Solid Tumors Overview Dual-masked CD3 T-cell engager targeting PSMA Target disease: Prostate cancer Phase 1 study ongoing (NCT05997615) Preliminary Phase 1 monotherapy dose escalation data presented at ASCO GU 2026 RECIST and PSA responses observed in heavily pre-treated mCRPC patients 45% ORR, 1 patient in treatment for ~300 days No DLT; CRS Mainly Grade 1, Despite No Prophylaxis *Confirmed PSA responders of PSA50 or better PSA-evaluable participant dosed at ≥ 3000 ug/kg Q3W Latest data