Astellas Pharma Inc. · TSE:4503

Astellas Pharma — Q1 FY2025 Earnings Presentation

45 slides from Astellas Pharma's earnings presentation, Jul 30, 2025

  1. Slide 1: Q1 YTD/FY2025 Financial Results

    Q1 YTD/FY2025 Financial Results Atsushi Kitamura Chief Financial Officer (CFO) Astellas Pharma Inc. July 30, 2025

  2. Slide 2: Cautionary Statement Regarding Forward-Looking Information

    Cautionary Statement Regarding Forward-Looking Information 2 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 sta

  3. Slide 3: Q1 YTD/FY2025 Overview

    Q1 YTD/FY2025 Overview 3 - Exceptional Q1 Progress Outperforming Expectations - Q1 YTD/FY2025 Consolidated Financial Results Revenue  Robust growth YoY (underlying growth excluding FX impact: +12%)  Strategic Brands: Significantly driving overall revenue growth (underlying growth excluding FX impa

  4. Slide 4: Agenda

    Agenda 4 I Q1 YTD/FY2025 Consolidated Financial Results II Pipeline Progress

  5. Slide 5: Q1 YTD/FY2025 Financial Results

    Q1 YTD/FY2025 Financial Results 5 Q1 YTD Q1 YTD Change FY2025 FX impact Underlying Growth (billion yen) Change (YoY) FY2024 FY2025 (%) FCST* (Excl. FX Impact) Revenue 473.1 505.8 +32.7 +6.9% 1,930.0 -26.1 +12% Cost of sales 91.1 94.8 +3.7 +4.1% 373.0 -2.9 SG&A expenses 206.9 197.0 -9.9 -4.8% 805.0 -

  6. Slide 6: Q1 YTD/FY2025 Financial Results: Main Brands

    Q1 YTD/FY2025 Financial Results: Main Brands 6 Strategic Brands expanded to over 110.0 bil. yen in just three months, driving overall revenue and profit growth YoY Underlying Growth (billion yen) Q1 YTD/FY2025 (Incl. FX Impact) (Excl. FX Impact) Strategic Brands  Continued strong growth, with notab

  7. Slide 7: IZERVAY: Business Update (US)

    IZERVAY: Business Update (US) 7 Q1 YTD/FY2025 YoY Q1 Performance - Record high quarterly sales - ¥ basis 15.9 bil. yen +3.2 (+25%) • Returned to growth trajectory, with a +22% QoQ growth • Continues to be #1 chosen treatment for new patient start $ basis $110M +29 (+35%)  New patient start share: ~

  8. Slide 8: PADCEV & VYLOY: Business Update

    PADCEV & VYLOY: Business Update 8 Strong growth sales driven by 1L mUC, overall progress in line with expectations Q1 YTD/FY2025 YoY • Continued robust growth momentum driven by 1L mUC across all regions Global Sales 55.5 bil. yen +17.1 (+45%)  Ex-US: Substantial sales growth (+113% YoY), notably a

  9. Slide 9: Q1 YTD/FY2025 Financial Results: Cost Items

    Q1 YTD/FY2025 Financial Results: Cost Items 9  Overall progress in costs on track. Cost optimization through SMT progressing well (total approx. -6.0 bil. yen)  SG&A*: Ratio improved by 4.2 ppt YoY. While driving SMT, continue investments in SBs to maximize potential  R&D: Expand investments from

  10. Slide 10: Agenda

    Agenda 10 I Q1 YTD/FY2025 Consolidated Financial Results II Pipeline Progress

  11. Slide 11: Strategic Brands: FY2025 Key Expected Events

    Strategic Brands: FY2025 Key Expected Events 11 (Blue: Updates since the last financial results announcement) Q1 (Apr-Jun) Q2 (Jul-Sep) Q3 (Oct-Dec) Q4 (Jan-Mar) avacincaptad Stargardt disease/ MHLW decision pegol/ Phase 2b: (GA secondary to AMD IZERVAY Jun Primary endpoint not met /Japan) MIBC/EV-3

  12. Slide 12: Progress in Focus Area Approach

    Progress in Focus Area Approach 12 (Blue: Updates since the last financial results announcement) PoC judgment PoC* judgment Convergence Program FY2025 (Primary Focus) FY2024 Q1 (Apr-Jun) Q2 (Jul-Sep) Q3 (Oct-Dec) Q4 (Jan-Mar) ASP3082 (Targeted Protein CRC • Prioritize PF Degradation) PoC achieved Po

  13. Slide 13: Progress in Primary Focus Targeted Protein Degradation

    Progress in Primary Focus Targeted Protein Degradation 13 (Blue: Updates since the last financial results announcement) Program Mechanism of action Target disease Origin/Partner Current phase Remarks • PoC achieved in PDAC (based on 2/3L data) and NSCLC (based on 2L+ data) Phase 1 ASP3082 KRAS G12D

  14. Slide 14: Progress in Focus Area Approach: ASP7317 (Blindness & Regeneration)

    Progress in Focus Area Approach: ASP7317 (Blindness & Regeneration) 14 Progressing toward PoC judgment in 2H/FY2025 with encouraging initial clinical data Overview of Program <Mean BCVA change over time> (Cohort 2: SVI patients, medium dose, n=3; Replacement therapy with retinal pigment epithelial B

  15. Slide 15: Exclusive License Agreement with Evopoint

    Exclusive License Agreement with Evopoint 15 A promising new asset to enhance Astellas’ leading position in Claudin 18.2-targeted therapies Overview of Agreement <Preliminary efficacy in CLDN18.2+ G/GEJ adenocarcinoma>1 (CLDN18.2+: CLDN18.2 expression ≥5%, IHC ≥2+)  Worldwide (excluding China’s mai

  16. Slide 16: Portfolio of Claudin 18.2-Targeted Therapies

    Portfolio of Claudin 18.2-Targeted Therapies 16 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 •

  17. Slide 17: Key Takeaways

    Key Takeaways 17 Exceptional Q1 progress outperforming expectations Expect continued positive momentum throughout FY2025 Strategic Brands  Expect continued strong momentum to drive overall revenue and profit growth Focus Area approach  Further PoC judgment of flagship programs  Accelerate program

  18. Slide 18: Appendix

    Appendix Wrastellas

  19. Slide 19: Strategic Brands: Potential Peak Sales (as of Jul 2025)

    Strategic Brands: Potential Peak Sales (as of Jul 2025) 19 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 (gilteritin

  20. Slide 20: Capital Allocation

    Capital Allocation 20 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 Conti

  21. Slide 21: Q1 YTD/FY2025 Actual: FX Rate

    Q1 YTD/FY2025 Actual: FX Rate 21 Average rate for the period Currency Q1 YTD/FY2024 Q1 YTD/FY2025 Change USD 156 yen 145 yen -11 yen EUR 168 yen 164 yen -4 yen <Impact of exchange rate on financial results>  Revenue: -26.1 billion yen  Core OP: -7.1 billion yen

  22. Slide 22: FY2025 Forecast: FX Rate & FX Sensitivity

    FY2025 Forecast: FX Rate & FX Sensitivity 22 Exchange rate FY2024 FY2025 FCST Change Average for the period USD 152 yen 140 yen -12 yen EUR 164 yen 160 yen -4 yen Estimated FX sensitivity of FY2025 forecasts by 1 yen depreciation Average rate Currency 1 yen depreciation from assumption Revenue Core

  23. Slide 23: Balance Sheet & Cash Flow Highlights

    Balance Sheet & Cash Flow Highlights 23 (billion yen) Mar 31, 2025 Jun 30, 2025 Total assets 3,339.5 3,335.8 Cash and cash equivalents 188.4 215.4 Total equity attributable to owners of the parent 1,513.3 1,481.8 Equity ratio (%) 45.3% 44.4% (billion yen) Q1 YTD/FY2024 Q1 YTD/FY2025 Cash flows from

  24. Slide 24: Balance of Bonds and Borrowings Highlights

    Balance of Bonds and Borrowings Highlights 24 （billion yen） Mar 31, 2025 Jun 30, 2025 Balance of bonds and borrowings 831.4 889.5 Non-current liabilities 564.9 558.1 Bonds 320.0 320.0 Long-term borrowings 244.9 238.1 Current liabilities 266.5 331.4 Commercial papers 164.9 230.7 Short-term borrowings

  25. Slide 25: Main Intangible Assets (as of Jun 30, 2025)

    Main Intangible Assets (as of Jun 30, 2025) 25 Bil. yen Foreign currency** AT132 15.6 $109M AT845 10.5 $73M Gene therapy related technology* 60.0 $417M VEOZAH** 83.4 €503M VYLOY** 58.4 €450M IZERVAY （US） 585.5 $4,066M IZERVAY (Ex-US） 49.7 $345M ASP7317 24.8 $172M VEOZAH: Approved as “VEOZA” in ex-US

  26. Slide 26: Sustainable Margin Transformation

    Sustainable Margin Transformation 26  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 annual benefi

  27. Slide 27: Lifecycle Management of Strategic Brands

    Lifecycle Management of Strategic Brands 27 (Blue: Updates since the last financial results announcement) Brand Indication Current status Next milestone Muscle-invasive bladder Data readout (interim analysis) anticipated Phase 3 EV-303 & EV-304 studies ongoing cancer for Q2-Q4/FY2025 Regulatory deci

  28. Slide 28: Progress in Focus Area Approach: Current Status of Programs in Clinical Trial

    Progress in Focus Area Approach: 28 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 Phase 1 study

  29. Slide 29: Overview of Primary Focus Flagship Programs (1/2)

    Overview of Primary Focus Flagship Programs (1/2) 29 ASP3082 (Targeted Protein Degradation) ASP2138 (Immuno-Oncology） Protein degrader targeting KRAS G12D mutant Bispecific antibody targeting CLDN18.2 and CD3  Target disease: Cancers harboring KRAS G12D mutation  Target disease: Gastric/GEJ (G/GEJ

  30. Slide 30: Overview of Primary Focus Flagship Programs (2/2)

    Overview of Primary Focus Flagship Programs (2/2) 30 AT845 (Genetic Regulation) ASP7317 (Blindness & Regeneration) Recombinant AAV8 continuously expressing hGAA gene Replacement therapy with retinal pigment epithelial cells specially in muscle aiming to maintain and restore visual functions  Target

  31. Slide 31: Robust Pipeline of Astellas

    Robust Pipeline of Astellas 31 Phase 1 Phase 2 Phase 3 Submitted/Filed ASP1570 gilteritinib enfortumab vedotin avacincaptad pegol (Newly diagnosed AML, HIC-ineligible) (MIBC) (GA secondary to AMD: Japan) ASP2138 zolbetuximab gilteritinib (Pancreatic adenocarcinoma) (Earlier-stage AML, pediatric use)

  32. Slide 32: Progress in Overall Pipeline

    Progress in Overall Pipeline 32 Phase 1 Entry to Approval Since the Last Financial Results Announcement Phase 1 Entry Phase 2 Entry Phase 3 Entry Filing Approval ASP546C/XNW27011 Cancer ASP1012: Cancer (Phase 1) Discontinuation enfortumab vedotin: Other solid tumors (Phase 2), Non-muscle-invasive bl

  33. Slide 33: Strategic Brands: Status Update

    Strategic Brands: Status Update 33 (Blue: Updates since the last financial results announcement) Generic / Brand name Indication Current status Muscle-invasive bladder cancer • Phase 3 studies ongoing (enrollment completed) enfortumab vedotin/ Non-muscle-invasive bladder cancer • Terminated PADCEV O

  34. Slide 34: enfortumab vedotin (EV) (1/5): Nectin-4 Targeted ADC

    enfortumab vedotin (EV) (1/5): Nectin-4 Targeted ADC 34 Overview of Development The most significant growth driver is 1L mUC indication, which is expected to account for more than half of total <Already approved / pivotal phase> (Included in potential peak sales) Pivotal study Target filing Number o

  35. Slide 35: enfortumab vedotin (EV) (2/5): Clinical Studies

    enfortumab vedotin (EV) (2/5): Clinical Studies 35 (Blue: Updates since the last financial results announcement) Urothelial cancer P3: EV-303 MIBC, Cis-ineligible; NCT03924895 n=595 Enrollment completed /KEYNOTE-905 Pembro +/- EV (perioperative) + RC vs. RC alone P3: EV-304 MIBC, Cis-eligible; EV +

  36. Slide 36: enfortumab vedotin (EV) (3/5): Study Data by Disease Stage of UC

    enfortumab vedotin (EV) (3/5): Study Data by Disease Stage of UC 36 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-in

  37. Slide 37: enfortumab vedotin (EV) (4/5): Study Data in 1L mUC (EV-302)

    enfortumab vedotin (EV) (4/5): Study Data in 1L mUC (EV-302) 37 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 mPFS (95% CI), HR 2-sided m

  38. Slide 38: enfortumab vedotin (EV) (5/5): Development for Muscle-invasive bladder cancer

    enfortumab vedotin (EV) (5/5): 38 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: Cystectomy Arm A [3 cycles] pCR Pembro [14

  39. Slide 39: avacincaptad pegol (ACP): Complement C5 Inhibitor / Pegylated RNA Aptamer

    avacincaptad pegol (ACP): 39 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)  A

  40. Slide 40: fezolinetant: NK3 receptor antagonist

    fezolinetant: NK3 receptor antagonist 40 VMS has a significant negative impact on QoL Women’s Health Initiative (WHI) Study2  Physical symptoms include hot flashes and night sweats,  Initial data analyses showed an association between chronic HRT use which can impact sleep. and increased risk of c

  41. Slide 41: zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody

    zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody 41 (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  Five-year survival rate is ~6% for metastatic gastric and

  42. Slide 42: gilteritinib: FLT3 Inhibitor

    gilteritinib: FLT3 Inhibitor 42 PASHA (HOVON) PrE0905 (PrECOG) Chemo Maintenance ADMIRAL High- consolidation intensity GOSSAMER induction Maintenance chemo Transplant Salvage therapy FLT3 mut+ MORPHO AML Launched Low-intensity chemo VICEROY Monotherapy vs. salvage chemo Relapsed or refractory P3: AD

  43. Slide 43: enzalutamide (1/2): Androgen Receptor Inhibitor

    enzalutamide (1/2): Androgen Receptor Inhibitor 43 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 R

  44. Slide 44: enzalutamide (2/2): Phase 3 Study Data by Disease Stage

    enzalutamide (2/2): Phase 3 Study Data by Disease Stage 44 (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 (CRP

  45. Slide 45: On the forefront of healthcare change to turn innovative science into VALUE for patients

    On the forefront of healthcare change to turn innovative science into VALUE for patients

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