Astellas Pharma Inc. · TSE:4503

Astellas Pharma — Q1 FY2026 Earnings Presentation

38 slides from Astellas Pharma's earnings presentation, Aug 5, 2026

  1. Slide 1: Q1 YTD/FY2026 Financial Results

    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

  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: Q1 YTD/FY2026 Overview

    Q1 YTD/FY2026 Overview - Strong Q1 progress toward record-high full-year Revenue and Core OP - 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

  4. Slide 4: Agenda

    Agenda I Q1 YTD/FY2026 Consolidated Financial Results II Pipeline Progress 4 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES.

  5. Slide 5: Q1 YTD/FY2026 Financial Results

    Q1 YTD/FY2026 Financial Results Great start to FY2026, delivering robust revenue and Core/Full OP growth fueled by favorable FX impacts Q1 YTD Q1 YTD Change FX impact FY2026 (billion yen) Change FY2025 FY2026 (%) (YoY) FCST* Revenue 505.8 640.9 +135.1 +26.7% +60.0 2,220.0 Cost of sales 94.8 122.7 +2

  6. Slide 6: Q1 YTD/FY2026 Financial Results: Main Brands

    Q1 YTD/FY2026 Financial Results: Main Brands Continued strong momentum of Strategic Brands, driving overall revenue and profit growth (billion yen) Q1 YTD/FY2026 YoY Growth Strong momentum expected to continue throughout FY2026 Strategic Brands Total 160.3 +48.3 (+43%) PADCEV • Progress exceeding ex

  7. Slide 7: Q1 YTD/FY2026 Financial Results: Cost Items

    Q1 YTD/FY2026 Financial Results: Cost Items  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) Cost Items YoY change Ratio to Revenue (yen) Held flat Y

  8. Slide 8: Agenda

    Agenda I Q1 YTD/FY2026 Consolidated Financial Results II Pipeline Progress 8 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES.

  9. Slide 9: Strategic Brands: Progress of Lifecycle Management

    Strategic Brands: Progress of Lifecycle Management (Blue: Updates since the last financial results announcement) Regulatory Study Significant milestones achieved, notably PADCEV MIBC and VYLOY Phase 3 study activity progress FY2026 Brand Indication FY2027 Q1 (Apr-Jun) Q2 (Jul-Sep) Q3 (Oct-Dec) Q4 (J

  10. Slide 10: Pipeline Progress

    Pipeline Progress Pipeline progressing steadily in line with CSP2026, with two new Phase 3 studies opened for recruitment Major progress Pre-PoC PoC achieved Phase 3/Pivotal In market setidegrasib ASP5541 VIR-5500 • Phase 3 study recruiting for NSCLC SM TCE Prostate cancer (NCT07566052) Oncology ASP

  11. Slide 11: Progress in ASP546C

    Progress in ASP546C China Phase 2 study demonstrated anti-tumor activities in G/GEJA and PDAC 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: Propr

  12. Slide 12: Progress in setidegrasib

    Progress in setidegrasib Anti-tumor activities observed in biliary tract and gynecologic cancers Latest data  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 pat

  13. Slide 13: Expanding Primary Focus: From Targeted Protein Degradation to Induced Proximity

    Expanding Primary Focus: From “Targeted Protein Degradation” to a Broader “Induced Proximity” Platform Induced Proximity unlocks differentiated pipeline potential in hard-to-treat cancers with long-term growth opportunity • Many disease-driving proteins remain difficult to target with conventional a

  14. Slide 14: Key Takeaways

    Key Takeaways Great start to FY2026, building strong momentum toward CSP2026 Robust Q1 Revenue and Profit Growth Solid Pipeline Progress • Strong Strategic Brands growth • Significant milestones achieved in LCM Driving robust revenue and profit growth, PADCEV (MIBC): Multiple approvals and filings,

  15. Slide 15: Appendix

    Appendix ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES.

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

    Strategic Brands: Potential Peak Sales (as of Jul 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: Q1 YTD/FY2026 Actual: FX Rate

    Q1 YTD/FY2026 Actual: FX Rate Average rate for the period Currency Q1 YTD/FY2025 Q1 YTD/FY2026 Change USD 145 yen 159 yen +15 yen EUR 164 yen 185 yen +21 yen <Impact of exchange rate on financial results>  Revenue: +60.0 billion yen  Core OP: +25.5 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 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

  20. Slide 20: Balance Sheet & Cash Flow Highlights

    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 1,829.0 1,942.7 Ratio of equity attributable to owners of the parent to total assets (%) 51.3% 52.6% (bill

  21. Slide 21: Balance of Bonds and Borrowings Highlights

    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 320.0 320.0 Bonds 220.0 220.0 Long-term borrowings 100.0 100.0 Current liabilities 246.0 269.9 Commercial papers - 300 Current portion of long-term b

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

    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

  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 FY27 (FY26-30) Additional 45B Yen Initiatives 200B Yen FY26 ($1

  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 (ASP3082) 1 In market In market Gastric and GEJ cancer AML NSCLC ASP5541 2 zolbetuximab gil

  25. Slide 25: 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 enfortumab vedotin enfortumab vedotin enfortumab vedotin Bladder-sparing Muscle-invasive bladder Muscle-invasive bladder muscle-invasive canc

  26. Slide 26: enfortumab vedotin (EV) (1/4): Nectin-4 Targeted ADC Number of Eligible Patients

    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)

  27. Slide 27: 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; sNDA submitted in Japan in Jan 2026 NCT03924895 n=595 /KEYNOTE-905 Pembro +/- EV (perioperative) + RC vs. RC alone Type II va

  28. Slide 28: 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

  29. Slide 29: enfortumab vedotin (EV) (4/4): Development for MIBC

    enfortumab vedotin (EV) (4/4): Development for Muscle-Invasive Bladder Cancer (MIBC) (Blue: Updates since the last financial results announcement) 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 Pe

  30. Slide 30: zolbetuximab: anti-Claudin 18.2 Monoclonal Antibody

    zolbetuximab: anti-Claudin 18.2 Monoclonal Antibody (Blue: Updates since the last financial results announcement) 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 SPOTLIG

  31. Slide 31: 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

  32. Slide 32: 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

  33. Slide 33: setidegrasib: KRAS G12D Degrader

    setidegrasib: KRAS G12D Degrader (Blue: Updates since the last financial results announcement) 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: FY2

  34. Slide 34: 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 recruiting (NCT07673887)  Target disease: Gastric/GEJ (G/GEJ) adenocarcino

  35. Slide 35: 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

  36. Slide 36: ASP7317: Retinal Pigment Epithelial Cell

    ASP7317: Retinal Pigment Epithelial Cell (Blue: Updates since the last financial results announcement) Overview Latest data Transplantation of retinal pigment epithelial cells aiming to  Initial data from Phase 1b study presented at Association maintain and restore visual functions for Research in

  37. Slide 37: 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

  38. Slide 38: VIR-5500: Dual-masked CD3 T-cell Engager Targeting PSMA

    VIR-5500: Dual-masked CD3 T-cell Engager Targeting PSMA 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 dat

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