Astellas Pharma Inc. · TSE:4503

Astellas Pharma — Q2 YTD/FY2026 Earnings Presentation

43 slides from Astellas Pharma's earnings presentation, Nov 4, 2026

  1. Slide 1: Q2 YTD/FY2026 Financial Results

    Astellas Tsukuba Research Center Q2 YTD/FY2026 Financial Results Naoki Okamura President and CEO Astellas Pharma Inc. November 4, 2026 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES.

  2. 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

  3. Slide 3: Q2 YTD/FY2026 Overview

    Q2 YTD/FY2026 Overview - Strong Progress Outperforming Expectations, Upward Revision of Full-Year Forecast - - Continued Progress in Strengthening the Pipeline across all Stages - Q2 YTD Financial Results ✓ Robust growth in Revenue (+23% YoY) and Core OP (+50% YoY) ✓ Driven by strong Strategic Brand

  4. Slide 4: Agenda

    Agenda Q2 YTD/FY2026 Consolidated Financial Results I FY2026 Revised Forecast II Pipeline Progress 4 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES.

  5. Slide 5: Q2 YTD/FY2026 Financial Results

    Q2 YTD/FY2026 Financial Results Significant growth across Revenue, Core OP and Full OP Q2 YTD Q2 YTD Change FX impact FY2026 (billion yen) Change (YoY) FY2025 FY2026 (%) Initial FCST* Revenue 1,030.1 1,270.9 +240.7 +23.4% +99.3 2,220.0 Cost of sales 200.4 247.9 +47.5 +23.7% +14.1 445.0 SG&A expenses

  6. Slide 6: Q2 YTD/FY2026 Financial Results: Main Brands

    Q2 YTD/FY2026 Financial Results: Main Brands Strategic Brands achieved over 50% YoY growth, led by PADCEV, IZERVAY and VYLOY (billion yen) Q2 YTD/FY2026 YoY Growth Full-year forecast for Strategic Brands total raised to 680 bil. Yen Strategic Brands Primarily reflecting strong PADCEV performance Tot

  7. Slide 7: Q2 YTD/FY2026 Financial Results: Cost Items

    Q2 YTD/FY2026 Financial Results: Cost Items ⚫ SG&A expenses* held flat YoY through disciplined management, ratio improved by 3.4ppt YoY ⚫ Cost optimization (SMT): Approx. -22 billion Yen YoY (Total of SG&A expenses, R&D expenses, cost of sales) Cost Items YoY change Ratio to Revenue (yen) Held flat

  8. Slide 8: FY2026 Revised Forecast

    FY2026 Revised Forecast ⚫ Upward revision to Revenue and Core/Full OP, based on strong progress outperforming expectations ⚫ Core OP expected to reach 700 billion Yen and achieve 30% Core OP margin FY2025 FY2026 (billion yen) Initial Revised Main items of revision Actual Change FCST FCST Revenue 2,1

  9. Slide 9: Agenda

    Agenda Q2 YTD/FY2026 Consolidated Financial Results I FY2026 Revised Forecast II Pipeline Progress 9 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES.

  10. Slide 10: Strategic Brands: Progress of Lifecycle Management

    Strategic Brands: Progress of Lifecycle Management (Blue: Updates since the last financial results announcement) Regulatory Study Key milestones achieved in PADCEV MIBC and VEOZAH geographic expansion activity progress FY2026 Brand Indication FY2027 Q1 (Apr-Jun) Q2 (Jul-Sep) Q3 (Oct-Dec) Q4 (Jan-Mar

  11. Slide 11: Pipeline Progress

    Pipeline Progress Two Phase 3 studies FSD achieved, ASP6958/VIR-5500 PoC achieved Major progress Three new programs advanced into clinical stage setidegrasib Pre-PoC PoC achieved Phase 3/Pivotal In market • Phase 3 study for NSCLC FSD achieved in Discontinued PoC achieved Sep (NCT07566052) ASP6958/

  12. Slide 12: Progress in Focus Area Approach (1/2): Immuno-Oncology

    Progress in Focus Area Approach (1/2): Immuno-Oncology Key milestones achieved across multiple programs, further strengthening the Immuno-Oncology pipeline Key milestone achievements New programs ASP2138 ASP388B T-cell engager targeting CLDN18.2 and CD3 with SC route B7-H3 targeted iADC with dual pa

  13. Slide 13: Progress in Focus Area Approach (2/2): Blindness and Regeneration

    Progress in Focus Area Approach (2/2): Blindness and Regeneration Next-generation ophthalmology programs advancing into clinical development ASP2020 ASP2767 iPSC-derived RPE cell therapy with Universal Cell technology AAV-based gene therapy delivering dual transgene BDNF and TrkB ⚫ Target disease: S

  14. Slide 14: Key Takeaways

    Key Takeaways Continued strong momentum driving upward revision toward 30% Core OP margin Pipeline progress across all stages in line with CSP2026 Robust Financial Performance Solid Pipeline Progress • Strong Strategic Brands growth • Multiple regulatory milestones achieved in LCM Achieved over 50%

  15. Slide 15: Appendix

    Appendix ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES.

  16. Slide 16: Strategic Brands: Potential Peak Sales (as of Oct 2026)

    Strategic Brands: Potential Peak Sales (as of Oct 2026) Oncology Oncology Oncology Ophthalmology Women’s Health Peak Sales: Peak Sales: Peak Sales: Peak Sales: Peak Sales: 400-500B Yen 100-200B Yen 100-200B Yen 200-400B Yen 150-250B Yen ($2.7-3.3B) ($0.7-1.3B) ($0.7-1.3B) ($1.3-2.7B) ($1.0-1.7B) Con

  17. Slide 17: Capital Allocation Policy

    Capital Allocation Policy 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 Maintain Gross Debt*/EBITDA** of 1.0x to 1.5x to keep adequate debt capacity for potential larg

  18. Slide 18: Q2 YTD/FY2026 Actual: FX Rate

    Q2 YTD/FY2026 Actual: FX Rate Average rate for the period Currency Q2 YTD/FY2025 Q2 YTD/FY2026 Change USD 146 yen 159 yen +13 yen EUR 168 yen 184 yen +16 yen <Impact of exchange rate on financial results> ⚫ Revenue: +99.3 billion yen ⚫ Core OP: +41.2 billion yen 18 ©2026 ASTELLAS PHARMA INC. AND ITS

  19. Slide 19: FY2026 Forecast: FX Rate & FX Sensitivity

    FY2026 Forecast: FX Rate & FX Sensitivity Exchange rate FY2026 FY2026 Change Average for the period Initial FCST Revised FCST USD 150 yen 158 yen +8 yen EUR 180 yen 181 yen +1 yen Forecast rates Q3 onwards: 156 yen/USD, 177 yen/EUR Estimated FX sensitivity (Q3 onwards) of FY2026 forecasts by 1 yen d

  20. Slide 20: Balance Sheet & Cash Flow Highlights

    Balance Sheet & Cash Flow Highlights (billion yen) Mar 31, 2026 Sep 30, 2026 Total assets 3,567.0 3,527.8 Cash and cash equivalents 281.6 238.2 Total equity attributable to owners of the parent 1,829.0 1,981.7 Ratio of equity attributable to owners of the parent to total assets (%) 51.3% 56.2% (bill

  21. Slide 21: Balance of Bonds and Borrowings Highlights

    Balance of Bonds and Borrowings Highlights (billion yen) Jun 30, 2026 Sep 30, 2026 Balance of bonds and borrowings 589.9 424.9 Non-current liabilities 320.0 270.0 Bonds 220.0 220.0 Long-term borrowings 100.0 50.0 Current liabilities 269.9 154.9 Commercial papers 30.0 74.9 Short-term borrowings - 30.

  22. Slide 22: Main Intangible Assets (as of Sep 30, 2026)

    Main Intangible Assets (as of Sep 30, 2026) Bil. yen Foreign currency** AT845 11.4 $73M Gene therapy related technology* 57.0 $362M VEOZAH** 81.5 €450M VYLOY** 52.0 €400M IZERVAY （US） 520.0 $3,304M IZERVAY (Ex-US） 48.0 $305M ASP7317 27.1 $172M ASP6958/VIR-5500 37.8 $240M ASP546C 23.0 n/a VEOZAH: App

  23. Slide 23: Disciplined Cost Optimization

    Disciplined Cost Optimization ⚫ Recurring cost optimization target 200B Yen over CSP2026 period ⚫ Reinvest for pipeline growth and sustain elevated profitability Sustainable Margin Transformation (SMT) Recurring Cost Optimization Target FY2027 (FY2026-2030) Additional 45B Yen Initiatives 200B Yen FY

  24. Slide 24: Our Pipeline

    Our Pipeline Prostate Cancer Phase Upper GI and Pancreatic Cancer Phase Acute Myeloid Leukemia Phase Solid Tumors Phase XTANDI (enzalutamide) In market VYLOY (zolbetuximab) XOSPATA (gilteritinib) setidegrasib 3 In market In market Gastric and GEJ cancer AML NSCLC ASP6958/VIR-5500 1 zolbetuximab gilt

  25. Slide 25: Key Upcoming Milestones

    Key Upcoming Milestones FY2026 FY2027 FY2028 FY2029 PoC judgment (G/GEJ combo with setidegrasib (2L+ NSCLC) setidegrasib (1L PDAC) pembro and chemo) ✓ AT845 (Pompe disease) ✓ Phase 3 LUCERNA study ✓ Phase 3 study data readout ✓ Phase 3 study data readout ✓ ASP2138 (PDAC) data readout (VMS in breast

  26. Slide 26: 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 ASP2020 ASP2138 fezolinetant enfortumab vedotin Stargardt-type macular Gastric and Vasomotor symptoms Muscle-invasive bladder dystrophies gas

  27. Slide 27: 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)

  28. Slide 28: 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; Type II variation approved in Europe in Jun 2026 NCT03924895 n=595 /KEYNOTE-905 Pembro +/- EV (perioperative) + RC vs. RC alo

  29. Slide 29: enfortumab vedotin (EV) (3/4): Study Data by Disease Stage

    enfortumab vedotin (EV) (3/4): Study Data by Disease Stage 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-ineligible Platinum pretreated eligible ineligible & Cis-ineligible

  30. Slide 30: enfortumab vedotin (EV) (4/4): Development for MIBC

    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

  31. Slide 31: 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

  32. Slide 32: 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

  33. Slide 33: gilteritinib: FLT3 Inhibitor

    gilteritinib: FLT3 Inhibitor 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 Acute myeloid leukemia P3: PASHA (HOVON) NCT04027309 Combo wit

  34. Slide 34: setidegrasib: KRAS G12D Degrader (1/2)

    setidegrasib: KRAS G12D Degrader (1/2) Overview Non-small cell lung cancer (NSCLC) ⚫ Rate of patients with KRAS G12D mutation: ⚫ Phase 3 study in 2L+ NSCLC ongoing (NCT07566052) ~40% in PDAC, ~5% in NSCLC1 ✓ Primary analysis anticipated: FY2028 setidegrasib QW N=356 Primary endpoint: R (1:1) PFS, OS

  35. Slide 35: setidegrasib: KRAS G12D Degrader (2/2)

    setidegrasib: KRAS G12D Degrader (2/2) (Blue: Updates since the last financial results announcement) Pancreatic ductal adenocarcinoma (PDAC) ⚫ Phase 3 study in 1L PDAC ongoing (NCT07409272) ⚫ Translational mechanism of response and resistance data ✓ Primary analysis anticipated: FY2029 (interim anal

  36. Slide 36: ASP2138: T-cell Engager Targeting Claudin 18.2 and CD3

    ASP2138: T-cell Engager Targeting Claudin 18.2 and CD3 (Blue: Updates since the last financial results announcement) Overview Current status T-cell engager targeting CLDN18.2 and CD3 with SC route ⚫ Phase 3 study in 1L G/GEJ ongoing (NCT07673887) ⚫ Target disease: Gastric/GEJ (G/GEJ) adenocarcinoma

  37. Slide 37: ASP546C: Antibody-Drug Conjugate Targeting Claudin 18.2

    ASP546C: Antibody-Drug Conjugate (ADC) Targeting Claudin 18.2 Overview Latest data Antibody-drug conjugate (ADC) targeting ⚫ Clinical data from China Phase 2 study presented at ASCO 2026 CLDN18.2 <Efficacy in 2L+ G/GEJA (CLDN18.2 ≥20%) @ 3mg/kg, mono> ⚫ Payload: Proprietary topoisomerase I inhibitor

  38. Slide 38: 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 • T-cell engager • Antibody-drug conjugate (Bispecific antibody ) Mode of • Immune cell-mediated • Immune cell-mediated • Di

  39. Slide 39: PDAC: Accelerating development targeting KRAS G12D mutation and CLDN18.2

    PDAC: Accelerating development targeting KRAS G12D mutation and CLDN18.2 • Estimated number of patients* (overall PDAC): ~176,000 in 1L, ~40,000 in 2L • SoC for metastatic PDAC: Chemotherapy KRAS G12D + CLDN18.2 +** ~40% in PDAC1 ~60% in PDAC2 setidegrasib ASP2138 Phase 3 study in 1L PDAC ongoing (N

  40. Slide 40: ASP6958/VIR-5500: Dual-masked CD3 T-cell Engager Targeting PSMA

    ASP6958/VIR-5500: Dual-masked CD3 T-cell Engager Targeting PSMA (Blue: Updates since the last financial results announcement) Overview Latest data Dual-masked CD3 T-cell engager targeting PSMA ⚫ Preliminary Phase 1 monotherapy dose escalation data presented ⚫ Target disease: Prostate cancer Tumor-bi

  41. Slide 41: ASP7317: Retinal Pigment Epithelial Cell

    ASP7317: Retinal Pigment Epithelial Cell Overview Latest data Transplantation of retinal pigment epithelial cells aiming to ⚫ Initial data from Phase 1b study presented at Association for maintain and potentially repair visual functions Research in Vision and Ophthalmology (ARVO) 2026 ⚫ Target disea

  42. Slide 42: Avoiding Immune Rejection through “Universal Cell”

    Avoiding Immune Rejection through “Universal Cell” Generation of Clinical-Grade Gene Editing Using Human iPS Cell Lines rAAV ⚫ Designed to avoid Immune Rejection by HLA Gene Editing ➢ Removal of HLA Class I/II to evade T cell-mediated attack ➢ Expression of HLA-E to avoid NK cell-mediated attack (Ba

  43. Slide 43: AT845: AAV8 Based Gene Therapy Expressing hGAA Gene

    AT845: AAV8 Based Gene Therapy Expressing hGAA Gene 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

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