Astellas Pharma Inc. · TSE:4503
Astellas Pharma — FY2025 Earnings Presentation
53 slides from Astellas Pharma's earnings presentation, Apr 27, 2026
Slide 1: FY2025 Financial Results
FY2025 Financial Results Naoki Okamura President and CEO Astellas Pharma Inc. April 27, 2026 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES.
Slide 2: Cautionary Statement Regarding Forward-Looking Information
Cautionary Statement Regarding Forward-Looking Information 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 state
Slide 3: Agenda
Agenda I FY2025 Results II FY2026 Outlook III Review of Corporate Strategic Plan 2021 3 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES.
Slide 4: FY2025 Overview
FY2025 Overview - Record-high Revenue (over 2.1 trillion yen) and Core OP (over 550.0 billion yen) - Financial Results Revenue Significant growth of Strategic Brands (over +140.0 bil. yen YoY), driving double-digit revenue growth (+12% YoY) SG&A expenses* Robust SMT progress, driving improvement in
Slide 5: FY2025 Financial Results
FY2025 Financial Results Breaking records across Revenue, Core OP and Full OP - All-time highs Change Fx impact FY2025 (billion yen) FY2024 FY2025 Change (%) (YoY) FCST Revenue 1,912.3 2,139.2 +226.9 +11.9% +30.1 2,100.0 Cost of sales 349.2 408.4 +59.2 +17.0% +10.3 406.0 SG&A expenses 843.0 860.3 +1
Slide 6: FY2025 Financial Results: Main Brands
FY2025 Financial Results: Main Brands All Brands increased across the board, with Strategic Brands total growing over 140.0 bil. yen YoY (billion yen) FY2025 Act YoY Growth Significant growth driving overall revenue and profit growth Strategic Brands Total 480.3 +143.9 (+43%) PADCEV • Sales growth d
Slide 7: FY2025 Financial Results: Cost Items
FY2025 Financial Results: Cost Items Cost optimization (SMT): Achieved ~25.0 bil. yen (SG&A expenses, R&D expenses, cost of sales) SG&A ratio improved by 2.3ppt YoY Cost Items YoY change Ratio to Revenue (billion yen) YoY increase excl. FX impact: approx. +15.0 Strategic Brands-related expense
Slide 8: Lifecycle Management of Strategic Brands: FY2025 Achievements
Lifecycle Management of Strategic Brands: FY2025 Achievements (Blue： Updates since the last financial results announcement) Strong development progress toward maximization of Strategic Brands value, notably for PADCEV Brand Indication Key achievements Cis-ineligible: Phase 3 EV-303 study primary end
Slide 9: enfortumab vedotin (EV) / PADCEV: Latest Status
enfortumab vedotin (EV) / PADCEV: Latest Status Starting development for bladder-sparing MIBC to potentially maximize PADCEV’s impact Cisplatin-eligible MIBC Potential upside in MIBC EV-304 study data1: Bladder-sparing MIBC (Perioperative EV + pembro vs. neoadjuvant chemo) ~30% of MIBC patient
Slide 10: Progress in Focus Area Approach: FY2025 Achievements
Progress in Focus Area Approach: FY2025 Achievements Flagship program FSD Initiation of pivotal study PoC PoC achieved Significant pipeline progress: 3 PoCs achieved, 1 Phase 3 study initiated FSD Clinical entry 3 clinical entries, 2 promising assets in-licensed NEW Newly in-licensed Biology/ Progre
Slide 11: Progress in Focus Area Approach: New Clinical Programs
Progress in Focus Area Approach: New Clinical Programs Next-generation innovative programs advancing into clinical development ASP2998 ASP2957 ASP2246 TROP2-targeted immunostimulatory ADC Next-generation gene therapy for XLMTM Direct reprogramming using mRNA-LNP (iADC) with dual payloads with novel
Slide 12: Agenda
Agenda I FY2025 Results II FY2026 Outlook III Review of Corporate Strategic Plan 2021 12 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES.
Slide 13: FY2026 Outlook: Overview
FY2026 Outlook: Overview - Expected to reach record-high Revenue and OP - FY2026 Forecast Revenue: Over 2.2 trillion yen (+4% YoY) driven by significant growth in Strategic Brands (+130.0 bil. yen, +27% YoY) Cost items: Continue cost optimization through SMT (~40.0 bil. yen) SG&A expenses*: Fu
Slide 14: FY2026 Forecast
FY2026 Forecast Record-high Revenue over 2.2 trillion yen and Core OP over 600.0 billion yen Core OP margin to reach 27.9% driven by Strategic Brands growth and SMT cost optimization FX rates for FY2026 FCST: 150 yen/USD, 180 yen/EUR FX rates for FY2025 Actual: 151 yen/USD, 175 yen/EUR FY2025 FY
Slide 15: FY2026 Forecast: Main Brands
FY2026 Forecast: Main Brands Strategic Brands to drive overall revenue and profit growth, led by PADCEV, IZERVAY and VYLOY Strategic Brands Total FY2026 Forecast 610.0 bil. yen PADCEV • Continued strong growth driven by 1L mUC, especially in post- reimbursement EST market YoY Growth • Contribution t
Slide 16: Lifecycle Management of Strategic Brands: FY2026 Key Expected Events
Lifecycle Management of Strategic Brands: FY2026 Key Expected Events Expecting multiple regulatory events across Strategic Brands Regulatory activity Study progress FY2026 Brand Indication FY2027+ Q1 (Apr-Jun) Q2 (Jul-Sep) Q3 (Oct-Dec) Q4 (Jan-Mar) Europe: Regulatory decision Japan: Regulatory decis
Slide 17: Progress in Pipeline: FY2026 Key Expected Events
Progress in Pipeline: FY2026 Key Expected Events Phase 3 studies to be initiated for ASP2138 and setidegrasib (NSCLC) Pre-PoC PoC achieved Pivotal study FY2026: G/GEJ ASP2138 1H/FY2026: Additional data to be presented Anti-CLDN18.2/anti-CD3 Phase 3 study initiation Gastrointestinal T-cell engager ca
Slide 18: Agenda
Agenda I FY2025 Results II FY2026 Outlook III Review of Corporate Strategic Plan 2021 18 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES.
Slide 19: Transformation of Organizational Culture and Operating Model
Transformation of Organizational Culture and Operating Model Executed initiatives to continuously generate innovations and embedded them across company Fostering organizational culture End-to-end operating model • Set Organizational Health Goals • Shift from region- or function-based to “patient axi
Slide 20: Review of Performance Goals in Corporate Strategic Plan 2021
Review of Performance Goals in Corporate Strategic Plan 2021 Established a foundation to overcome XTANDI LOE and deliver sustainable growth Performance Goal 1 Performance Goal 2 Performance Goal 3 Revenue: Pipeline Value: Core OP Margin: XTANDI and Strategic Brands sales Focus Area projects expected
Slide 21: Three Enterprise Priorities
Three Enterprise Priorities Set “Three Enterprise Priorities” closely linked to Performance Goals and launched full-scale implementation in FY2024 $ Sustainable Margin Growth Strategy Bold Ambition Transformation • Maximize potential of • Increase pipeline value • Company-wide cost optimization Stra
Slide 22: Growth Strategy: Maximize Potential of Strategic Brands
Growth Strategy: Maximize Potential of Strategic Brands Strategic Brands delivered exceptional growth, Achieving ~10x growth over five years Diversified and profitable Strategic Brands portfolio PADCEV MIBC Approval ~480B yen VYLOY Launch • Majority fully owned and high margin brands, IZERVAY Launch
Slide 23: Bold Ambition: Increase Pipeline Value
Bold Ambition: Increase Pipeline Value 4 PoCs achieved from 3 Primary Focus flagship programs Forming franchises by leveraging strengths, together with follow-on programs and external assets Key Modalities Pre-PoC PoC achieved In market Disease Areas Primary Focuses VIR-5500 ASP5541 Prostate can
Slide 24: Sustainable Margin Transformation: Company-wide Cost Optimization
Sustainable Margin Transformation: Company-wide Cost Optimization Achieved cumulative total 65.0 bil. yen cost optimization over 2 years Fully on track to achieve total cost optimization target of 150.0 bil. yen Achievement ¥150B Identified cost reduction initiatives ¥40B ¥25B ¥65B ¥25B ¥10B ¥ 6
Slide 25: Revenue and Core OP Growth over CSP2021 Period
Revenue and Core OP Growth over CSP2021 Period Significant increase in Revenue and Core OP by 1.7x and 2.2x, respectively, over 5 years Revenue Core OP 26.0% ¥2.1T+ Strategic Brands Core OP margin ¥550.0B+ 19.2% ~¥250.0B ~¥1.3T FY21 FY22 FY23 FY24 FY25 FY21 FY22 FY23 FY24 FY25 Core OP is based on th
Slide 26: Key Takeaways
Key Takeaways Established a foundation to overcome XTANDI LOE and deliver sustainable growth $ Strategic Brands delivered Established a robust pipeline, Significant progress towards exceptional growth, raising building confidence towards resilient cost structure driven prospects for further expansio
Slide 27: Corporate Strategic Plan 2026
Upcoming Event Corporate Strategic Plan 2026 May 26th, 4:00 pm – 5:30 pm (JST) 27 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES.
Slide 28: Appendix
Appendix ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES.
Slide 29: Strategic Brands: Potential Peak Sales (as of Apr 2026)
Strategic Brands: Potential Peak Sales (as of Apr 2026) Potential Peak Sales Brand (Global, billions of yen) PADCEV (enfortumab vedotin) * 400.0 – 500.0 IZERVAY (avacincaptad pegol) 200.0 – 400.0 (US alone) VEOZAH (fezolinetant) 150.0 – 250.0 VYLOY (zolbetuximab) 100.0 – 200.0 XOSPATA (gilteritinib)
Slide 30: Capital Allocation
Capital Allocation 1 Top priority is investment for 2 Raise dividend level aligned 3 Flexibly execute share business growth with profit / cashflow plan and buyback by excess cash actual performance throughout CSP2021 period <Appropriate leverage level> Gross Debt*/EBITDA** of 1.0x to 1.5x Continue
Slide 31: FY2025 Actual: FX Rate
FY2025 Actual: FX Rate Average rate for the period Currency FY2024 FY2025 Change USD 152 yen 151 yen -2 yen EUR 164 yen 175 yen +11 yen <Impact of exchange rate on financial results> Revenue: 30.1 billion yen Core OP: 16.8 billion yen 31 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES.
Slide 32: FY2026 Forecast: FX Rate & FX Sensitivity
FY2026 Forecast: FX Rate & FX Sensitivity Exchange rate FY2025 FY2026 FCST Change Average for the period USD 151 yen 150 yen -1 yen EUR 175 yen 180 yen +5 yen Estimated FX sensitivity FY2026 forecasts by 1 yen depreciation Average rate Currency 1 yen depreciation from assumption Revenue Core OP USD
Slide 33: Balance Sheet & Cash Flow Highlights
Balance Sheet & Cash Flow Highlights (billion yen) FY2024 end FY2025 end Total assets 3,339.5 3,567.0 Cash and cash equivalents 188.4 281.6 Total equity attributable to owners of the parent 1,513.3 1,829.0 Ratio of equity attributable to owners of the parent to total assets (%) 45.3% 51.3% (billion
Slide 34: Balance of Bonds and Borrowings Highlights
Balance of Bonds and Borrowings Highlights (billion yen) Dec 31, 2025 Mar 31, 2026 Balance of bonds and borrowings 725.3 566.0 Non-current liabilities 320.0 320.0 Bonds 220.0 220.0 Long-term borrowings 100.0 100.0 Current liabilities 405.3 246.0 Commercial papers 119.9 - Short-term borrowings 20.0 -
Slide 35: Main Intangible Assets (as of Mar 31, 2026)
Main Intangible Assets (as of Mar 31, 2026) Bil. yen Foreign currency** AT845 11.5 $73M Gene therapy related technology* 61.0 $384M VEOZAH** 85.8 €471M VYLOY** 54.6 €420M IZERVAY （US） 572.7 $3,609M IZERVAY (Ex-US） 51.9 $327M ASP7317 27.3 $172M VEOZAH: Approved as “VEOZA” in ex-US *Acquired during th
Slide 36: Sustainable Margin Transformation
Sustainable Margin Transformation Company-wide cost optimization of 150.0 billion yen before XTANDI LOE Fund growth investment and profit improvement Core OP margin Sustainable Margin Transformation 30% • Company-wide cost optimization before XTANDI LOE Recurring FY2024 FY2027 Aspirational • Fun
Slide 37: Nonclinical data for New Programs
Nonclinical data for New Programs ASP2998 ASP2957 ASP2246 Antitumor efficacy in mouse model1 Dose-dependent efficacy in mouse model Neuronal induction from astrocyte3 (motor function)2 Cell: U-251 (human astrocytoma) Motor function score in monkey chronic stroke model3 MC38-huTROP2 cells were inocul
Slide 38: Robust Pipeline of Astellas
Robust Pipeline of Astellas Phase 1 Phase 2 Phase 3 Submitted/Filed gilteritinib enfortumab vedotin gilteritinib enfortumab vedotin (ALK-positive non-small cell lung cancer) (Bladder-sparing MIBC) (Earlier-stage AML, pediatric use) (Cisplatin-ineligible MIBC: Europe, Japan) ASP2138 gilteritinib zolb
Slide 39: Progress in Overall Pipeline
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 VIR-5500 enfortumab vedotin setidegrasib enfortumab vedotin Prostate cancer Bladder-sparing Pancreatic ductal Muscle-invasive bladder muscle-
Slide 40: enfortumab vedotin (EV) (1/4): Nectin-4 Targeted ADC
enfortumab vedotin (EV) (1/4): Nectin-4 Targeted ADC Number of Eligible Patients Pivotal study Number of eligible Patient segment (EV regimen) patients* EV-303 Cis-ineligible 38,000 (combo w/ Pembro) EV-304 MIBC** Cis-eligible 59,000 (combo w/ Pembro) EV-309 Bladder-sparing 34,000 (combo w/ Pembro)
Slide 41: enfortumab vedotin (EV) (2/4): Clinical Studies
enfortumab vedotin (EV) (2/4): Clinical Studies (Blue: Updates since the last financial results announcement) sBLA approved in US in Nov 2025 P3: EV-303 MIBC, Cis-ineligible; NCT03924895 n=595 Type II variation accepted in Europe in Nov 2025 /KEYNOTE-905 Pembro +/- EV (perioperative) + RC vs. RC alo
Slide 42: enfortumab vedotin (EV) (3/4): Study Data by Disease Stage
enfortumab vedotin (EV) (3/4): Study Data by Disease Stage (Blue: Updates since the last financial results announcement) Early stage Late stage MIBC mUC Disease stage Surgery eligible Previously untreated (first line) PD-1/L1 inhibitor pretreated Cis- Cis- Platinum naïve Platinum eligible Cis-inelig
Slide 43: enfortumab vedotin (EV) (4/4): Development for Muscle-Invasive Bladder Cancer
enfortumab vedotin (EV) (4/4): Development for Muscle-Invasive Bladder Cancer (MIBC) 1) Phase 3 study in Cis-ineligible MIBC (KEYNOTE-905/EV-303): Perioperative EV + Pembro vs. Cystectomy alone EFS and OS span the duration of the trial Pembro Endpoints: Arm A Pembro [14 cycles] Cystectomy [3 cycle
Slide 44: zolbetuximab: anti-Claudin 18.2 Monoclonal Antibody
zolbetuximab: anti-Claudin 18.2 Monoclonal Antibody 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 Latest
Slide 45: fezolinetant: NK3 Receptor Antagonist
fezolinetant: NK3 Receptor Antagonist (Blue: Updates since the last financial results announcement) VMS has a significant negative impact on QoL Women’s Health Initiative (WHI) Study2 Physical symptoms include hot flashes and night sweats, which can Initial data analyses showed an association be
Slide 46: gilteritinib: FLT3 Inhibitor
gilteritinib: FLT3 Inhibitor (Blue: Updates since the last financial results announcement) PASHA (HOVON) PrE0905 (PrECOG) Chemo Maintenance ADMIRAL High- consolidation GOSSAMER intensity induction Maintenance chemo Transplant Salvage therapy FLT3 mut+ MORPHO AML Launched Low-intensity chemo VICEROY
Slide 47: Progress in setidegrasib
Progress in setidegrasib Overview Pancreatic ductal adenocarcinoma (PDAC) Rate of patients with KRAS G12D mutation: Phase 3 study in 1L PDAC ongoing (NCT07409272) ~40% in PDAC, ~5% in NSCLC1 Primary analysis anticipated: FY2029 (interim analysis) Phase 1 study ongoing (NCT05382559) setidegra
Slide 48: Pipeline of Primary Focus Targeted Protein Degradation
Pipeline of Primary Focus Targeted Protein Degradation (Blue: Updates since the last financial results announcement) Program Mechanism of Action Target Disease Origin/Partner Current Phase Recent Updates • PDAC: PoC achieved, Phase 3 study KRAS G12D+ solid initiated setidegrasib KRAS G12D degrader t
Slide 49: Progress in ASP2138
Progress in ASP2138 Overview Latest data3 Bispecific antibody targeting CLDN18.2 and CD3 with SC route Safety and tolerability supports combination with SoC Target disease: Gastric/GEJ (G/GEJ) adenocarcinoma and PDAC chemotherapy and checkpoint inhibitors Rate of CLDN18.2-positive patients*:
Slide 50: Portfolio of Claudin 18.2-Targeted Therapies
Portfolio of Claudin 18.2-Targeted Therapies Aim to address broader patient population with multiple differentiated assets VYLOY ASP2138 ASP546C Modality • Monoclonal antibody • Bispecific antibody • Antibody-drug conjugate (T-cell engager) Mode of • Immune cell-mediated • Immune cell-mediated • Dir
Slide 51: Progress in ASP7317
Progress in ASP7317 Overview Latest data Transplantation of retinal pigment epithelial cells aiming to Initial data from Phase 1b study presented at Retinal maintain and restore visual functions Therapeutics Innovation Summit 2025 Target disease: GA secondary to AMD No IOI events and no eviden
Slide 52: Progress in AT845
Progress in AT845 Overview Latest data Recombinant AAV8 continuously expressing hGAA gene Follow-up data from Phase 1/2 FORTIS study presented at specially in muscle WORLDSymposium 2026 Target disease: Pompe disease Of the 6 participants with ≥1 year follow-up, 5 remained off Estimated incid
Slide 53: VIR-5500
VIR-5500 Overview Dual-masked CD3 T-cell engager targeting PSMA PSA-evaluable participant dosed at ≥ 3000 ug/kg Q3W Target disease: Prostate cancer Phase 1 study ongoing (NCT05997615) Latest data Preliminary Phase 1 monotherapy dose escalation data presented at ASCO GU 20261 Encouraging RECI