Astellas Pharma Inc. · TSE:4503

Astellas Pharma — Q3 2025 Earnings Presentation

45 slides from Astellas Pharma's earnings presentation, Feb 6, 2026

  1. Slide 1: Q3 YTD/FY2025 Financial Results

    Q3 YTD/FY2025 Financial Results Atsushi Kitamura Chief Financial Officer (CFO) Astellas Pharma Inc. February 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: Q3 YTD/FY2025 Overview

    Q3 YTD/FY2025 Overview - Strong Momentum Continues; Another Upward Revision of Full-year Forecast - Q3 YTD Financial Results Revenue Continued strong growth of Strategic Brands (Over +100.0 bil. yen YoY), driving double-digit revenue growth (+10% YoY) SG&A expenses* Robust SMT progress, driving cont

  4. Slide 4: Agenda

    Agenda Q3 YTD/FY2025 Consolidated Financial Results I FY2025 Revised Forecast II Pipeline Progress 4 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES.

  5. Slide 5: Q3 YTD/FY2025 Financial Results

    Q3 YTD/FY2025 Financial Results Revenue and Core OP each increased by approx. 150.0 bil. yen YoY, Full OP increased significantly Q3 YTD Q3 YTD Change Fx impact FY2025 (billion yen) Change (YoY) FY2024 FY2025 (%) FCST * Revenue 1,453.0 1,601.3 +148.3 +10.2% -2.2 2,030.0 Cost of sales 272.3 314.8 +42

  6. Slide 6: Q3 YTD/FY2025 Financial Results: Main Brands

    Q3 YTD/FY2025 Financial Results: Main Brands All Brands increased across the board, with Strategic Brands total growing over 100.0 bil. yen YoY (billion yen) Q3 YTD/FY2025 YoY Strategic Brands Total 353.2 +109.3 (+45%) ✓ High profitability of Strategic Brands contributing to elevation of core OP mar

  7. Slide 7: Q3 YTD/FY2025 Financial Results: Cost Items

    Q3 YTD/FY2025 Financial Results: Cost Items ⚫ Cost optimization (SMT): Progressing ahead of plan (Q3 YTD: approx. 20.0 bil. yen) Fully on track to achieve FY2027 cost optimization target of 150.0 bil. yen ⚫ SG&A ratio improved by 2.7 ppt YoY Cost Items YoY change Ratio to Revenue (billion yen) YoY i

  8. Slide 8: FY2025 Revised Forecast

    FY2025 Revised Forecast ⚫ Another upward revision of Revenue and Core/Full OP, reflecting continued strong momentum ⚫ Expect Core OP margin to achieve 24.8% (+4.2ppt vs. FY2024) Exchange rates of FY2025 latest forecast: 150 yen/USD, 174 yen/EUR (Forecast rates of Q4/FY2025: 154 yen/USD, 180 yen/EUR)

  9. Slide 9: Agenda

    Agenda Q3 YTD/FY2025 Consolidated Financial Results I FY2025 Revised Forecast II Pipeline Progress 9 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES.

  10. Slide 10: Strategic Brands: FY2025 Key Expected Events

    Strategic Brands: FY2025 Key Expected Events (Blue: Updates since the last financial results announcement) Significant progress in development of PADCEV MIBC: US approval just 1 month after sBLA acceptance Q1 (Apr-Jun) Q2 (Jul-Sep) Q3 (Oct-Dec) Q4 (Jan-Mar) avacincaptad Stargardt disease/ Approval (

  11. Slide 11: zolbetuximab/VYLOY: Latest Status

    zolbetuximab/VYLOY: Latest Status Promising data supporting combination with checkpoint inhibitor + chemotherapy presented Latest Data1 Current Status ⚫ Phase 2 ILUSTRO study Cohort 4B ⚫ Phase 3 LUCERNA study ongoing (zolbetuximab + nivolumab + mFOLFOX6; ✓ zolbetuximab + pembrolizumab + Chemo vs. mo

  12. Slide 12: Progress in Focus Area Approach

    Progress in Focus Area Approach (Blue: Updates since the last financial results announcement) ⚫ ASP3082/setidegrasib: Promising data in PDAC with high unmet medical need presented ⚫ ASP2138: PoC achieved PoC judgment PoC* judgment Convergence Program FY2025 (Primary Focus) FY2024 Q1 (Apr-Jun) Q2 (Ju

  13. Slide 13: Progress in ASP3082/setidegrasib & Primary Focus Targeted Protein Degradation

    Progress in ASP3082/setidegrasib & Primary Focus Targeted Protein Degradation Promising data in 1L PDAC presented, anticipated to initiate Phase 3 study by March Latest Data1 Response rates ASP3082 600 mg + mFOLFIRINOX ⚫ ASP3082 + mFOLFIRINOX combination showed promising ORR, n (%) 7/12 (58.3) antit

  14. Slide 14: Key Takeaways

    Key Takeaways Strong Momentum Another Upward Revision Significant Advancement Continues in Q3 of Full-year Forecast of Pipeline • Strategic Brands: • Revenue +70.0 bil. yen • PADCEV and VYLOY: Continued strong growth Progress in LCM • Core OP +30.0 bil. yen • SG&A ratio continues to • ASP3082 and AS

  15. Slide 15: Upcoming Events

    Upcoming Events Next Corporate Sustainability Meeting R&D Day FY2025 Earnings February 26, 10:00-11:15 (JST) Late March Late April Strategic Plan Late May 15 ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES.

  16. Slide 16: Appendix

    Appendix ©2026 ASTELLAS PHARMA INC. AND ITS AFFILIATES.

  17. Slide 17: Strategic Brands: Potential Peak Sales (as of Feb 2026)

    Strategic Brands: Potential Peak Sales (as of Feb 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)

  18. Slide 18: 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

  19. Slide 19: Q3 YTD/FY2025 Actual: FX Rate

    Q3 YTD/FY2025 Actual: FX Rate Average rate for the period Currency Q3 YTD/FY2024 Q3 YTD/FY2025 Change USD 152 yen 149 yen -4 yen EUR 165 yen 172 yen +7 yen <Impact of exchange rate on financial results> ⚫ Revenue: -2.2 billion yen ⚫ Core OP: +4.2 billion yen 19 ©2026 ASTELLAS PHARMA INC. AND ITS AFF

  20. Slide 20: FY2025 Forecast: FX Rate & FX Sensitivity

    FY2025 Forecast: FX Rate & FX Sensitivity Exchange rate FY2025 FY2025 Change Average for the period Previous FCST Latest FCST USD 145 yen 150 yen +5 yen EUR 170 yen 174 yen +4 yen Forecast rates of Q4: 154 yen/USD, 180 yen/EUR Estimated FX sensitivity of Q4 (Jan-Mar 2026) of FY2025 forecasts by 1 ye

  21. Slide 21: Balance Sheet & Cash Flow Highlights

    Balance Sheet & Cash Flow Highlights (billion yen) Mar 31, 2025 Dec 31, 2025 Total assets 3,339.5 3,603.9 Cash and cash equivalents 188.4 254.3 Total equity attributable to owners of the parent 1,513.3 1,763.1 Ratio of equity attributable to owners of the parent to total assets (%) 45.3% 48.9% (bill

  22. Slide 22: Balance of Bonds and Borrowings Highlights

    Balance of Bonds and Borrowings Highlights (billion yen) Sep 30, 2025 Dec 31, 2025 Balance of bonds and borrowings 740.5 725.3 Non-current liabilities 320.0 320.0 Bonds 220.0 220.0 Long-term borrowings 100.0 100.0 Current liabilities 420.5 405.3 Commercial papers 99.9 119.9 Short-term borrowings 20.

  23. Slide 23: Main Intangible Assets (as of Dec 31, 2025)

    Main Intangible Assets (as of Dec 31, 2025) Bil. yen Foreign currency** AT132 17.0 $109M AT845 11.4 $73M Gene therapy related technology* 61.9 $395M VEOZAH** 86.9 €482M VYLOY** 55.9 €430M IZERVAY （US） 589.2 $3,761M IZERVAY (Ex-US） 52.9 $338M ASP7317 27.0 $172M VEOZAH: Approved as “VEOZA” in ex-US *A

  24. Slide 24: 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

  25. Slide 25: Robust Pipeline of Astellas

    Robust Pipeline of Astellas Phase 1 Phase 2 Phase 3 Submitted/Filed gilteritinib gilteritinib enfortumab vedotin enfortumab vedotin (ALK-positive non-small cell lung cancer) (Newly diagnosed AML, HIC-ineligible) (Cisplatin-eligible MIBC) (Cisplatin-ineligible MIBC: Europe, Japan) ASP1570 resamirigen

  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 enfortumab vedotin enfortumab vedotin Muscle-invasive bladder Muscle-invasive bladder cancer who are ineligible cancer who are ineligible for

  27. Slide 27: Lifecycle Management of Strategic Brands

    Lifecycle Management of Strategic Brands (Blue: Updates since the last financial results announcement) Brand Indication Current status Next milestone Cis-eligible: sBLA filing anticipated for CY2026 Muscle-invasive Phase 3 EV-304 study primary endpoint met bladder cancer Bladder-sparing: (Under disc

  28. Slide 28: enfortumab vedotin (EV) (1/5): Nectin-4 Targeted ADC

    enfortumab vedotin (EV) (1/5): Nectin-4 Targeted ADC Overview of Development (Blue: Updates since the last financial results announcement) <Already approved / pivotal phase> (Included in potential peak sales) Pivotal study Number of eligible Patient segment Target filing timing (EV regimen) patients

  29. Slide 29: enfortumab vedotin (EV) (2/5): Clinical Studies

    enfortumab vedotin (EV) (2/5): 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

  30. Slide 30: enfortumab vedotin (EV) (3/5): Study Data by Disease Stage of UC

    enfortumab vedotin (EV) (3/5): Study Data by Disease Stage of UC (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-

  31. Slide 31: enfortumab vedotin (EV) (4/5): Study Data in Cis-ineligible MIBC (EV-303)

    enfortumab vedotin (EV) (4/5): Study Data in Cis-ineligible MIBC (EV-303) Unprecedented data in EV-303, showing the potential as a new standard of care for Cis-ineligible MIBC <Event-free survival (EFS)> <Overall survival (OS)> 100 100 86.3% 90 77.8% 90 79.7% 74.7% EV + Pembro Event-free survival, %

  32. Slide 32: enfortumab vedotin (EV) (5/5): Development for Muscle-Invasive Bladder Cancer (MIBC)

    enfortumab vedotin (EV) (5/5): 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 cycles]

  33. Slide 33: zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody

    zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody Target: Claudin 18.2 (CLDN18.2) Gastric and GEJ adenocarcinoma ⚫ Claudin is a major structural component of tight junctions and ⚫ Five-year survival rate is ~6% for metastatic gastric seals intercellular space in epithelial sheets cancer patients a

  34. Slide 34: 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

  35. Slide 35: 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

  36. Slide 36: enzalutamide (1/2): Androgen Receptor Inhibitor

    enzalutamide (1/2): Androgen Receptor Inhibitor Localized Prostate Cancer Castration-Sensitive Castration-Resistant Prostate Cancer Prostate Cancer ARCHES M1 CSPC PREVAIL AFFIRM newly-diagnosed M1 CRPC M1 CRPC M1 CSPC (1st line) (2nd line+) recurrent Local Therapy PSA Initial Surgery, Radiation Recu

  37. Slide 37: enzalutamide (2/2): Phase 3 Study Data by Disease Stage

    enzalutamide (2/2): Phase 3 Study Data by Disease Stage Continued potential in earlier lines with consistent survival benefit and longer duration of treatment Early stage Late stage Castration-sensitive (CSPC) Castration-resistant (CRPC) Disease stage M1 M1 M0 M1 M0 (pre-chemo) (post-chemo) Phase 3

  38. Slide 38: Progress in Focus Area Approach: Current Status of Programs in Clinical Trial

    Progress in Focus Area Approach: Current Status of Programs in Clinical Trial (Blue: Updates since the last financial results announcement) Primary Focus Biology/Modality/Technology Program Mechanism of action Current status Checkpoint ASP1570 DGKζ inhibitor Phase 1/2 study ongoing Immuno- Phase 1 s

  39. Slide 39: Overview of Primary Focus Flagship Programs (1/2)

    Overview of Primary Focus Flagship Programs (1/2) (Blue: Updates since the last financial results announcement) ASP3082/setidegrasib (Targeted Protein Degradation) ASP2138 (Immuno-Oncology） Protein degrader targeting KRAS G12D mutant Bispecific antibody targeting CLDN18.2 and CD3 with SC route ⚫ Tar

  40. Slide 40: Overview of Primary Focus Flagship Programs (2/2)

    Overview of Primary Focus Flagship Programs (2/2) AT845 (Genetic Regulation) ASP7317 (Blindness & Regeneration) Recombinant AAV8 continuously expressing hGAA gene Replacement therapy with retinal pigment epithelial cells aiming specially in muscle to maintain and restore visual functions ⚫ Target di

  41. Slide 41: Pipeline of Primary Focus Targeted Protein Degradation

    Pipeline of Primary Focus Targeted Protein Degradation Program Mechanism of Action Target Disease Origin/Partner Current Phase Recent Updates • PDAC: PoC achieved, Phase 3 study Phase 1 planned to start in Q4/FY2025 setidegrasib/ KRAS G12D+ solid KRAS G12D degrader • NSCLC: PoC achieved ASP3082 tumo

  42. Slide 42: Progress in ASP2138 / Primary Focus Immuno-Oncology

    Progress in ASP2138 / Primary Focus Immuno-Oncology Early data showed a benefit of SC administration in combination with SoC Latest Data1 1L G/GEJ adenocarcinoma; ASP2138 SC Q2W + Pembro + mFOLFOX6 ⚫ Safety and tolerability supports combination with SoC chemotherapy and checkpoint inhibitors ⚫ ASP21

  43. Slide 43: 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

  44. Slide 44: Progress in ASP7317 (Blindness & Regeneration)

    Progress in ASP7317 (Blindness & Regeneration) Encouraging initial clinical data obtained Overview of Program <Mean BCVA change over time> (Cohort 2: SVI patients, medium dose, n=3; Replacement therapy with retinal pigment epithelial BCVA: 15-37 letters (≥20/500 to ≤20/200)) cells aiming to maintain

  45. Slide 45: Progress in AT845 (Genetic Regulation)

    Progress in AT845 (Genetic Regulation) Encouraging initial clinical data obtained <Forced vital capacity> Overview of Program Recombinant AAV8 continuously expressing hGAA gene specially in muscle ⚫ Target disease: Pompe disease ✓ Estimated incidence: 1 in ~40,0001 Withdrawal from ERT ⚫ Standard of

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