Astellas Pharma Inc. · TSE:4503

Astellas Pharma — FY2024 Earnings Presentation

53 slides from Astellas Pharma's earnings presentation, Apr 25, 2025

  1. Slide 1: FY2024 Financial Results

    FY2024 Financial Results Naoki Okamura President and CEO Astellas Pharma Inc. April 25, 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: Agenda

    Agenda 3 I FY2024 Consolidated Financial Results II FY2024 Pipeline Update III FY2025 Outlook

  4. Slide 4: FY2024 Financial Results: Overview

    FY2024 Financial Results: Overview 4 Revenue and Core operating profit reached record high since establishment of Astellas Revenue  Increased significantly YoY (+19%)  Strategic Brands: Expanded to approx. 340.0 bil. yen (approx. +180.0 bil. yen YoY) SG&A expenses*  Achieved SMT target (optimizat

  5. Slide 5: FY2024 Financial Results

    FY2024 Financial Results 5 Change FY2024 (billion yen) FY2023 FY2024 Change FX impact (YoY) (%) FCST Revenue 1,603.7 1,912.3 +308.7 +19.2% 1,900.0 +68.1 Cost of sales 292.5 349.2 +56.7 +19.4% 345.0 +6.9 SG&A expenses 740.1 843.0 +102.9 +13.9% 845.0 +34.9 US XTANDI co-pro fee 194.9 252.6 +57.7 +29.6%

  6. Slide 6: FY2024 Financial Results: Main Brands

    FY2024 Financial Results: Main Brands 6 Strategic Brands achieved over 2x growth, significantly driving overall revenue and profit growth (billion yen) FY2024 Act YoY Strategic Brands Delivered over 2x growth YoY, demonstrating substantial growth 336.4  Total +176.5 (+110%)  Strategic Brands’ prof

  7. Slide 7: FY2024 Financial Results: SMT (Sustainable Margin Transformation)

    FY2024 Financial Results： 7 SMT (Sustainable Margin Transformation)  Achieved cost optimization of 40.0 bil. yen through SMT  Improved SG&A* ratio to 30.9% (-3.1 ppt YoY)  Allocated resources generated by SMT to growth investments (Strategic Brands and Primary Focus) Recurring Key results in FY20

  8. Slide 8: Drivers of Core OP Growth

    Drivers of Core OP Growth 8  FY2024 Core OP increased significantly YoY (+115.5 bil. yen)  Strategic Brands’ profitability contributed substantially to Core OP growth  Strong SMT progress, generated further growth investment Core OP Core OP 276.9 bil. yen 17.3% 392.4 bil. yen (Core OP margin: 17.

  9. Slide 9: Agenda

    Agenda 9 I FY2024 Consolidated Financial Results II FY2024 Pipeline Update III FY2025 Outlook

  10. Slide 10: Main Brands: FY2024 Key Events

    Main Brands: FY2024 Key Events 10 (Blue: Updates since the last financial results announcement) Achieved label/indication/geographic expansion for IZERVAY, PADCEV and VYLOY as key growth drivers Q1 (Apr-Jun) Q2 (Jul-Sep) Q3 (Oct-Dec) Q4 (Jan-Mar) Jan Complete response Approval avacincaptad (Label up

  11. Slide 11: Progress in Focus Area Approach (1/2): ASP3082 (Targeted Protein Degradation)

    Progress in Focus Area Approach (1/2): ASP3082 (Targeted Protein Degradation) 11 Successfully achieved the first PoC, leading to acceleration of the flagship and follow-on programs Overview of Program Potential of TPD as a Platform Protein degrader targeting KRAS G12D mutant Overcome limitations of

  12. Slide 12: Progress in Focus Area Approach (2/2): AT845 (Genetic Regulation)

    Progress in Focus Area Approach (2/2): AT845 (Genetic Regulation) 12 Progressing toward PoC judgment in 2H/FY2025 with encouraging clinical data <Forced vital capacity> Overview of Program Recombinant AAV8 continuously expressing hGAA gene specially in muscle  Target disease: Pompe disease  Estima

  13. Slide 13: Agenda

    Agenda 13 I FY2024 Consolidated Financial Results II FY2024 Pipeline Update III FY2025 Outlook

  14. Slide 14: End-to-End Activities Along Patient Axis

    End-to-End Activities Along Patient Axis 14 Promote activities swiftly and efficiently from early research through to commercialization and LCM Patient Axis VALUE Creation VALUE Delivery Innovation Customer Engine Engagement Research & Commercial & Development Medical Affairs VALUE Enablement Corpor

  15. Slide 15: FY2025 Outlook: Overview

    FY2025 Outlook: Overview 15 Strategic Brands  Continued strong momentum to drive overall revenue and profit growth (underlying growth excluding FX impact: +50%)  Expect multiple data readouts from studies for lifecycle management Focus Area approach  Expect further PoC judgment of flagship progra

  16. Slide 16: FY2025 Forecast: Main Brands

    FY2025 Forecast: Main Brands 16 Continued strong momentum in Strategic Brands to drive overall revenue and profit growth (billion yen) FY2025 FCST YoY (vs. FY2024) Strategic Brands  Robust growth to continue in FY2025 (underlying growth excl. FX impact: +50% YoY) Total 470.0 +133.6 (+40%)  IZERVAY

  17. Slide 17: PADCEV & VYLOY: Business Update and Outlook

    PADCEV & VYLOY: Business Update and Outlook 17 Sales growth across all markets, driving sales toward 200.0 bil. yen FY2025 FCST YoY (vs. FY2024) • Strong global sales growth expected, driven by 1L mUC Global sales 200.0 bil. yen +35.9 (+22%) • 1L mUC approval countries increased to 21 US ($ basis) $

  18. Slide 18: IZERVAY: Business Update and Outlook (US)

    IZERVAY: Business Update and Outlook (US) 18 Return to growth trajectory following temporary downturn. High profitability to drive strong profit contribution FY2025 FCST YoY (vs. FY2024) 105.0 bil. yen +46.7 (+80%) Demand Trend (Vials) $ basis $750M +368 (+96%) Label Update (Feb 2025) • Temporary de

  19. Slide 19: Image of Profit Contribution from Strategic Brands

    Image of Profit Contribution from Strategic Brands 19 Sales growth of Strategic Brands significantly contributes to profit growth 470B yen approx. 340B yen Profit approx. 150B yen Strategic Brands sales Strategic Brands-related COGS Strategic Brands-related SG&A FY2023 FY2024 FY2025 Actual Actual Fo

  20. Slide 20: Strategic Brands: FY2025 Key Expected Events

    Strategic Brands: FY2025 Key Expected Events 20 Expect multiple data readouts from studies for lifecycle management Q1 (Apr-Jun) Q2 (Jul-Sep) Q3 (Oct-Dec) Q4 (Jan-Mar) avacincaptad MHLW decision Stargardt disease/ pegol/ (GA secondary to AMD Phase 2b IZERVAY /Japan) 1L head & neck/ MIBC/EV-303 & EV-

  21. Slide 21: Focus Area Approach: Future Outlook

    Focus Area Approach: Future Outlook 21 Advance PoC judgment of flagship programs and converge to prioritized Primary Focuses PoC judgment PoC judgment Convergence FY2025 FY2024 Q1 (Apr-Jun) Q2 (Jul-Sep) Q3 (Oct-Dec) Q4 (Jan-Mar) ASP3082 (Targeted Protein NSCLC CRC Degradation) PoC Achieved • Priorit

  22. Slide 22: FY2025 Forecast

    FY2025 Forecast 22  Increase in Revenue and Core OP. Solid underlying growth excluding FX impact  Continuous cost optimization through SMT, expect further improvement of SG&A ratio FX rates for FY2025 FCST: 140 yen/USD, 160 yen/EUR Underlying growth FX rates for FY2024 Actual: 152 yen/USD, 164 yen

  23. Slide 23: Key Takeaways

    Key Takeaways 23 Record-high Revenue and Core OP in FY2024 Further growth in FY2025, with double-digit underlying profit growth  Robust growth of Strategic Brands Expect further growth in FY2025, transition to substantial profit generating phase  PoC achieved in Targeted Protein Degradation Accele

  24. Slide 24: Appendix

    Appendix Wrastellas

  25. Slide 25: Strategic Brands: Potential Peak Sales (as of Apr 2025)

    Strategic Brands: Potential Peak Sales (as of Apr 2025) 25 Potential Peak Sales Brand (Global, billions of yen) * PADCEV (enfortumab vedotin) 400.0 – 500.0 IZERVAY (avacincaptad pegol) 200.0 – 400.0 VEOZAH (fezolinetant) 150.0 – 250.0 VYLOY (zolbetuximab) 100.0 – 200.0 XOSPATA (gilteritinib) 100.0 –

  26. Slide 26: Capital Allocation

    Capital Allocation 26 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 Continu

  27. Slide 27: FY2024 Actual: FX Rate

    FY2024 Actual: FX Rate 27 Average rate for the period Currency FY2023 FY2024 Change USD 145 yen 152 yen +8 yen EUR 157 yen 164 yen +7 yen <Impact of exchange rate on financial results>  Revenue: +68.1 billion yen  Core OP: +15.1 billion yen

  28. Slide 28: FY2025 Forecast: FX Rate & FX Sensitivity

    FY2025 Forecast: FX Rate & FX Sensitivity 28 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

  29. Slide 29: Balance Sheet & Cash Flow Highlights

    Balance Sheet & Cash Flow Highlights 29 (billion yen) FY2023 end FY2024 end Total assets 3,569.6 3,339.5 Cash and cash equivalents 335.7 188.4 Total equity attributable to owners of the parent 1,596.0 1,513.3 Equity ratio (%) 44.7% 45.3% (billion yen) FY2023 FY2024 Cash flows from operating activiti

  30. Slide 30: Balance of Bonds and Borrowings Highlights

    Balance of Bonds and Borrowings Highlights 30 （billion yen） Dec 31, 2024 Mar 31, 2025 Balance of bonds and borrowings 915.4 831.4 Non-current liabilities 585.5 564.9 Bonds 320.0 320.0 Long-term borrowings 265.5 244.9 Current liabilities 329.9 266.5 Commercial papers 179.8 164.9 Short-term borrowings

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

    Main Intangible Assets (as of Mar 31, 2025) 31 Bil. yen Foreign currency* AT132 16.3 $109M AT845 10.9 $73M Gene therapy related technology** 64.2 $428M VEOZAH* 86.2 €514M VYLOY* 59.7 €460M IZERVAY （US） 632.6 $4,218M IZERVAY (Ex-US） 51.7 $345M ASP7317 25.8 $172M VEOZAH: Approved as “VEOZA” in ex-US *

  32. Slide 32: Sustainable Margin Transformation

    Sustainable Margin Transformation 32  Company-wide cost optimization of 120-150 billion yen before XTANDI LOE  Fund growth investment and profit improvement Core OP margin Sustainable Margin Transformation Sustainable Margin Transformation 30% • Company-wide cost optimization • Continue to enhance

  33. Slide 33: Lifecycle Management of Strategic Brands

    Lifecycle Management of Strategic Brands 33 (Blue: Updates since the last financial results announcement) Brand Indication Current status Next milestone Data readout (interim analysis) anticipated MIBC Phase 3 EV-303 & EV-304 studies ongoing for 2H/CY2025 NMIBC Phase 1 EV-104 study ongoing Data read

  34. Slide 34: Progress in Focus Area Approach: Current Status of Programs in Clinical Trial

    Progress in Focus Area Approach: 34 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- ASP213

  35. Slide 35: Overview of Primary Focus Flagship Programs (1/2)

    Overview of Primary Focus Flagship Programs (1/2) 35 ASP3082 (Targeted Protein Degradation) ASP2138 (Immuno-Oncology） Protein degrader targeting KRAS G12D mutant Bispecific antibody targeting Claudin 18.2 and CD3  Target disease: Cancers harboring KRAS G12D mutation  Target disease: Gastric and GE

  36. Slide 36: Overview of Primary Focus Flagship Programs (2/2)

    Overview of Primary Focus Flagship Programs (2/2) 36 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

  37. Slide 37: Robust Pipeline of Astellas

    Robust Pipeline of Astellas 37 Phase 1 Phase 2 Phase 3 Submitted/Filed enfortumab vedotin enfortumab vedotin enfortumab vedotin avacincaptad pegol (NMIBC) (Other solid tumors) (MIBC) (GA secondary to AMD; Japan) ASP1570 gilteritinib gilteritinib (Newly diagnosed AML, HIC-ineligible) (Earlier-stage A

  38. Slide 38: Progress in Overall Pipeline

    Progress in Overall Pipeline 38 Phase 1 Entry to Approval Since the Last Financial Results Announcement Phase 1 Entry Phase 2 Entry Phase 3 Entry Filing Approval zocaglusagene avacincaptad pegol nuzaparvovec/AT845 Geographic atrophy Pompe disease secondary to age-related macular degeneration: Japan

  39. Slide 39: Strategic Brands: Status Update

    Strategic Brands: Status Update 39 (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 • Phase 1 study ongoi

  40. Slide 40: enfortumab vedotin (EV) (1/7): Nectin-4 Targeted ADC Overview of Development

    enfortumab vedotin (EV) (1/7): Nectin-4 Targeted ADC 40 Overview of Development  The most significant growth driver is 1L mUC indication, which is expected to account for more than half of total sales in the future  Success in NMIBC and other solid tumors may provide further growth potential <Alre

  41. Slide 41: enfortumab vedotin (EV) (2/7): Clinical Studies

    enfortumab vedotin (EV) (2/7): Clinical Studies 41 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 + Pembro (perioperative) + RC NCT04700124 n=808 Enrollment compl

  42. Slide 42: enfortumab vedotin (EV) (3/7): Study Data by Disease Stage of UC

    enfortumab vedotin (EV) (3/7): Study Data by Disease Stage of UC 42 (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 C

  43. Slide 43: enfortumab vedotin (EV) (4/7): Study Data in 1L mUC (EV-302)

    enfortumab vedotin (EV) (4/7): Study Data in 1L mUC (EV-302) 43 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

  44. Slide 44: enfortumab vedotin (EV) (5/7): Development for Muscle-invasive bladder cancer (MIBC)

    enfortumab vedotin (EV) (5/7): 44 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

  45. Slide 45: enfortumab vedotin (EV) (6/7): Development for Non-muscle-invasive bladder cancer (NMIBC)

    enfortumab vedotin (EV) (6/7): 45 Development for Non-muscle-invasive bladder cancer (NMIBC) Explore the activity of intravesical EV in earlier-stage urothelial cancer NMIBC Stages 0a-1 Tis: Carcinoma in situ Ta: Noninvasive papillary carcinoma T1: Tumor invades lamina propia ~70% ~30% BCG- BCG- res

  46. Slide 46: enfortumab vedotin (EV) (7/7): Study Data in Solid Tumors Other than Urothelial Cancer (EV-202)

    enfortumab vedotin (EV) (7/7): 46 Study Data in Solid Tumors Other than Urothelial Cancer (EV-202) ORR Cohort Cancer type n Target* Result 1 HR+/HER2- breast cancer 45 30% 15.6% 2 Triple-negative breast cancer 42 25% 19.0% 3 Squamous non-small cell lung cancer 23 17.5% 4.3% 4 Non-squamous non-small

  47. Slide 47: avacincaptad pegol (ACP): Complement C5 Inhibitor / Pegylated RNA Aptamer

    avacincaptad pegol (ACP): 47 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

  48. Slide 48: fezolinetant: NK3 receptor antagonist

    fezolinetant: NK3 receptor antagonist 48 (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,  Initial data analyses showed an association between c

  49. Slide 49: zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody

    zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody 49 (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

  50. Slide 50: gilteritinib: FLT3 Inhibitor

    gilteritinib: FLT3 Inhibitor 50 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

  51. Slide 51: enzalutamide (1/2): Androgen Receptor Inhibitor

    enzalutamide (1/2): Androgen Receptor Inhibitor 51 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

  52. Slide 52: enzalutamide (2/2): Phase 3 Study Data by Disease Stage

    enzalutamide (2/2): Phase 3 Study Data by Disease Stage 52 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

  53. Slide 53: 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

Astellas Pharma — FY2024 Earnings Presentation on 6ix