Astellas Pharma Inc. · TSE:4503
Astellas Pharma — Q2 2025 Earnings Presentation
43 slides from Astellas Pharma's earnings presentation, Oct 30, 2025
Slide 1: Q2 YTD/FY2025 Financial Results
Q2 YTD/FY2025 Financial Results Naoki Okamura President and CEO Astellas Pharma Inc. October 30, 2025 ©2025 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: Q2 YTD/FY2025 Overview
Q2 YTD/FY2025 Overview - Exceptional Progress Outperforming Expectations, Significant Upward Revision of Full-year Forecast - Q2 YTD Financial Results Revenue Significant increase in Revenue driven by continued strong growth of Strategic Brands (underlying growth excl. FX impact: +12% YoY) SG&A ex
Slide 4: Agenda
Agenda Q2 YTD/FY2025 Consolidated Financial Results I FY2025 Revised Forecast II Pipeline Progress 4 ©2025 ASTELLAS PHARMA INC. AND ITS AFFILIATES.
Slide 5: Q2 YTD/FY2025 Financial Results
Q2 YTD/FY2025 Financial Results Revenue and Core/Full OP all increased by approx. 100.0 bil. yen YoY Q2 YTD Q2 YTD Change FY2025 FX impact Underlying Growth (billion yen) Change (YoY) (Excl. FX Impact) FY2024 FY2025 (%) Initial FCST* Revenue 935.6 1,030.1 +94.5 +10.1% 1,930.0 -22.2 +12% Cost of sale
Slide 6: Q2 YTD/FY2025 Financial Results: Main Brands
Q2 YTD/FY2025 Financial Results: Main Brands Strategic Brands exceeds 220.0 bil. yen, driven primarily by strong growth in PADCEV and VYLOY YoY Underlying Growth (billion yen) Q2 YTD/FY2025 (Incl. FX Impact) (Excl. FX Impact) Strategic Brands Major driver for overall revenue and profit growth Tota
Slide 7: Q2 YTD/FY2025 Financial Results: Cost Items
Q2 YTD/FY2025 Financial Results: Cost Items Cost optimization through SMT progress exceeds expectations (total approx. 16.0 bil. yen) SG&A ratio improved by 3.1 ppt YoY Cost Items YoY change Ratio to Revenue (billion yen) YoY increase excl. FX impact: approx. +3.0 SMT cost optimization: approx
Slide 8: FY2025 Revised Forecast
FY2025 Revised Forecast Significant Upward revision of Revenue and Core/Full OP based on exceptional progress Expect Core OP margin 24.1% (+2.9ppt vs. initial forecast） Exchange rates of FY2025 revised forecast: 145 yen/USD, 170 yen/EUR (Forecast rates Q3/FY2025 onwards: 144 yen/USD, 172 yen/EUR
Slide 9: Agenda
Agenda Q2 YTD/FY2025 Consolidated Financial Results I FY2025 Revised Forecast II Pipeline Progress 9 ©2025 ASTELLAS PHARMA INC. AND ITS AFFILIATES.
Slide 10: Strategic Brands: FY2025 Key Expected Events
Strategic Brands: FY2025 Key Expected Events (Blue: Updates since the last financial results announcement) Success in PADCEV EV-303 study, sBLA accepted in US Q1 (Apr-Jun) Q2 (Jul-Sep) Q3 (Oct-Dec) Q4 (Jan-Mar) avacincaptad Stargardt disease/ Approval (Japan) <Other update> pegol/ Phase 2b: Primary
Slide 11: enfortumab vedotin (EV) / PADCEV: Latest Status
enfortumab vedotin (EV) / PADCEV: Latest Status 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, % 80 80 Overall survival, %
Slide 12: Progress in Focus Area Approach
Progress in Focus Area Approach (Blue: Updates since the last financial results announcement) Promising data in ASP3082 and ASP2138 presented PoC judgment PoC* judgment Convergence Program FY2025 (Primary Focus) FY2024 Q1 (Apr-Jun) Q2 (Jul-Sep) Q3 (Oct-Dec) Q4 (Jan-Mar) ASP3082 CRC (Targeted Protein
Slide 13: Progress in ASP3082 / Primary Focus Targeted Protein Degradation
Progress in ASP3082 / Primary Focus Targeted Protein Degradation Promising data in NSCLC presented, registrational studies under preparation for PDAC and NSCLC Latest Data1 ASP3082 monotherapy showed promising antitumor activity in an advanced NSCLC patient population ORR = 37.5% (9/24) in overa
Slide 14: 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, progressing toward PoC Latest Data1 1L G/GEJ adenocarcinoma; ASP2138 SC Q2W + Pembro + mFOLFOX6 Safety and tolerability supports combination with SoC chemotherapy and check
Slide 15: Key Takeaways
Key Takeaways Exceptional Q2 YTD Financial Results Strong growth of Strategic Brands driven by PADCEV and VYLOY Robust cost optimization through SMT Significant Upward Revision of Full-year Forecast Upward revision of Revenue (+100.0 bil. yen) and Core/Full OP (+80.0 bil. yen each) Robust Pipe
Slide 16: Appendix
Appendix ©2025 ASTELLAS PHARMA INC. AND ITS AFFILIATES.
Slide 17: Strategic Brands: Potential Peak Sales (as of Oct 2025)
Strategic Brands: Potential Peak Sales (as of Oct 2025) 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 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
Slide 19: Q2 YTD/FY2025 Actual: FX Rate
Q2 YTD/FY2025 Actual: FX Rate Average rate for the period Currency Q2 YTD/FY2024 Q2 YTD/FY2025 Change USD 152 yen 146 yen -6 yen EUR 166 yen 168 yen +2 yen <Impact of exchange rate on financial results> Revenue: -22.2 billion yen Core OP: -4.5 billion yen 19 ©2025 ASTELLAS PHARMA INC. AND ITS AF
Slide 20: FY2025 Forecast: FX Rate & FX Sensitivity
FY2025 Forecast: FX Rate & FX Sensitivity Exchange rate FY2025 FY2025 Change Average for the period Initial FCST Revised FCST USD 140 yen 145 yen +5 yen EUR 160 yen 170 yen +10 yen Forecast rates Q3 onwards: 144 yen/USD, 172 yen/EUR Estimated FX sensitivity (Q3 onwards) of FY2025 forecasts by 1 yen
Slide 21: Balance Sheet & Cash Flow Highlights
Balance Sheet & Cash Flow Highlights (billion yen) Mar 31, 2025 Sep 30, 2025 Total assets 3,339.5 3,450.3 Cash and cash equivalents 188.4 287.1 Total equity attributable to owners of the parent 1,513.3 1,612.4 Equity ratio (%) 45.3% 46.7% (billion yen) Q2 YTD/FY2024 Q2 YTD/FY2025 Cash flows from ope
Slide 22: Balance of Bonds and Borrowings Highlights
Balance of Bonds and Borrowings Highlights （billion yen） Jun 30, 2025 Sep 30, 2025 Balance of bonds and borrowings 889.5 740.5 Non-current liabilities 558.1 320.0 Bonds 320.0 220.0 Long-term borrowings 238.1 100.0 Current liabilities 331.4 420.5 Commercial papers 230.7 99.9 Short-term borrowings 20.
Slide 23: Main Intangible Assets (as of Sep 30, 2025)
Main Intangible Assets (as of Sep 30, 2025) Bil. yen Foreign currency** AT132 16.1 $109M AT845 10.7 $73M Gene therapy related technology* 60.1 $406M VEOZAH** 83.8 €493M VYLOY** 57.1 €440M IZERVAY （US） 578.8 $3,914M IZERVAY (Ex-US） 51.0 $345M ASP7317 25.5 $172M VEOZAH: Approved as “VEOZA” in ex-US *A
Slide 24: Sustainable Margin Transformation
Sustainable Margin Transformation Company-wide cost optimization of 120-150 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 • F
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: US) ASP1570 zolbetuximab gilteriti
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 gilteritinib ASP5541 enfortumab vedotin avacincaptad pegol Anaplastic lymphoma kinase- Prostate cancer Muscle-invasive bladder Geographic atr
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-ineligible: sBLA under review (US) PDUFA date: Apr 7, 2026 Muscle-invasive bladder cancer Data readout (interim analysis) anticipated for Cis-elig
Slide 28: enfortumab vedotin (EV) (1/5): Nectin-4 Targeted ADC
enfortumab vedotin (EV) (1/5): Nectin-4 Targeted ADC Overview of Development <Already approved / pivotal phase> (Included in potential peak sales) Pivotal study Number of eligible Patient segment Target filing timing (EV regimen) patients* EV-303 Cis-ineligible** FY2025 20,000*** (combo w/ Pembro) M
Slide 29: enfortumab vedotin (EV) (2/5): Clinical Studies
enfortumab vedotin (EV) (2/5): Clinical Studies (Blue: Updates since the last financial results announcement) P3: EV-303 MIBC, Cis-ineligible; NCT03924895 n=595 sBLA accepted in US in Oct 2025 /KEYNOTE-905 Pembro +/- EV (perioperative) + RC vs. RC alone P3: EV-304 MIBC, Cis-eligible; EV + Pembro (pe
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-
Slide 31: enfortumab vedotin (EV) (4/5): Study Data in 1L mUC (EV-302)
enfortumab vedotin (EV) (4/5): Study Data in 1L mUC (EV-302) Statistically significant and clinically meaningful improvement over chemotherapy with nearly doubled mOS and mPFS <Progression-free survival> <Overall survival> EV + Pembro EV + Pembro Chemo Chemo HR 2-sided Median (95% CI), HR 2-sided Me
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]
Slide 33: avacincaptad pegol (ACP): Complement C5 Inhibitor / Pegylated RNA Aptamer
avacincaptad pegol (ACP): Complement C5 Inhibitor / Pegylated RNA Aptamer (Blue: Updates since the last financial results announcement) Geographic atrophy (GA) Characteristics of ACP Advanced form of dry age-related macular degeneration Pegylated RNA aptamer (chemically synthesized) (AMD) ACP
Slide 34: IZERVAY: Data Presented at AAO 2025 (1/2)
IZERVAY: Data Presented at AAO 2025 (1/2) 34 ©2025 ASTELLAS PHARMA INC. AND ITS AFFILIATES.
Slide 35: IZERVAY: Data Presented at AAO 2025 (2/2)
IZERVAY: Data Presented at AAO 2025 (2/2) 35 ©2025 ASTELLAS PHARMA INC. AND ITS AFFILIATES.
Slide 36: 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 37: zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody
zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody (Blue: Updates since the last financial results announcement) 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 se
Slide 38: 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 39: 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
Slide 40: enzalutamide (2/2): Phase 3 Study Data by Disease Stage
enzalutamide (2/2): Phase 3 Study Data by Disease Stage (Blue: Updates since the last financial results announcement) Continued potential in earlier lines with consistent survival benefit and longer duration of treatment Early stage Late stage Castration-sensitive (CSPC) Castration-resistant (CRPC)
Slide 41: 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
Slide 42: Overview of Primary Focus Flagship Programs (1/2)
Overview of Primary Focus Flagship Programs (1/2) ASP3082 (Targeted Protein Degradation) ASP2138 (Immuno-Oncology） Protein degrader targeting KRAS G12D mutant Bispecific antibody targeting CLDN18.2 and CD3 with SC route Target disease: Cancers harboring KRAS G12D mutation Target disease: Gastric
Slide 43: 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