Astellas Pharma Inc. · TSE:4503

Astellas Pharma — Q1 2024 Earnings Presentation

38 slides from Astellas Pharma's earnings presentation, Aug 1, 2024

  1. Slide 1: Q1/FY2024 Financial Results

    Q1/FY2024 FINANCIAL RESULTS ENDED JUNE 30, 2024 Atsushi Kitamura Chief Financial Officer (CFO) Astellas Pharma Inc. August 1, 2024

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

    CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING 2 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 sta

  3. Slide 3: Agenda

    AGENDA 3 I Q1/FY2024 Consolidated Financial Results II Initiatives for Sustainable Growth

  4. Slide 4: Q1/FY2024 Financial Results: Overview

    Q1/FY2024 FINANCIAL RESULTS: OVERVIEW 4 Solid start toward achieving the FY2024 initial forecast Revenue  Increased YoY (+26%)  XTANDI: Contributed to overall growth, driven especially by the US  Strategic Brands: Expanded to 75.0 bil. yen in total Robust growth of approx. +50.0 bil. yen YoY (3 t

  5. Slide 5: Q1/FY2024 Financial Results

    Q1/FY2024 FINANCIAL RESULTS 5 Change FY24 (billion yen) Q1/FY23 Q1/FY24 Change FX impact (YoY) (%) FCST* Revenue 375.0 473.1 +98.1 +26.2% 1,650,0 +45.4 Cost of sales 68.9 91.1 +22.2 +32.2% 326.0 +6.1 SG&A expenses 168.2 206.9 +38.7 +23.0% 757.0 +20.8 US XTANDI co-pro fee 44.6 61.6 +17.0 +38.2% 189.0

  6. Slide 6: Q1/FY2024 Financial Results: XTANDI and Strategic Brands

    Q1/FY2024 FINANCIAL RESULTS: XTANDI AND STRATEGIC BRANDS 6 XTANDI contributed to overall growth, driven especially by the US (billion yen) Q1/FY2024 Act YoY FY2024 FCST*  Global sales off to a strong start, driven by higher-than-expected US performance 224.2 +50.2 （+29%） 757.0  US: Demand exceeded

  7. Slide 7: PADCEV & VEOZAH: Business Update

    PADCEV & VEOZAH: BUSINESS UPDATE 7 Robust sales growth driven by the US and EST. Expect further sales contribution going forward QoQ (vs. Q4/FY2023): +8.6 bil. yen (+29%) Q1/FY2024 Act YoY <US> Global sales 38.4 bil. yen +23.2 （+152%）  Significant contribution from 1L mUC share expansion New patien

  8. Slide 8: IZERVAY: Business Update (US)

    IZERVAY: BUSINESS UPDATE (US) 8 Performance exceeded expectations, particularly driven by stronger-than-expected demand following J-Code Prescriber perception of safety profile is favorable Q1/FY2024 Act YoY QoQ (vs. Q4/FY2023): +5.9 bil. yen (+86%) 12.7 bil. yen +12.7 <Q1 progress>  Progress follo

  9. Slide 9: Q1/FY2024 Financial Results: Cost Items

    Q1/FY2024 FINANCIAL RESULTS: COST ITEMS 9  SG&A and R&D expenses: Invested as planned for future growth  Timely cost management with a focus on ROI (mainly VEOZAH) Core basis: YoY comparison and ratio to revenue, for major cost items Cost Items YoY change Ratio to Revenue (billion yen) 19.3% YoY i

  10. Slide 10: Agenda

    AGENDA 10 I Q1/FY2024 Consolidated Financial Results II Initiatives for Sustainable Growth

  11. Slide 11: XTANDI and Strategic Brands: FY2024 Key Expected Events

    XTANDI AND STRATEGIC BRANDS: FY2024 KEY EXPECTED EVENTS 11 (Blue: Updates since the last financial results announcement) Q1 (Apr-Jun) Q2 (Jul-Sep) Q3 (Oct-Dec) Q4 (Jan-Mar) enzalutamide/ Approval XTANDI Jun (M1 CSPC; China) CHMP positive opinion enfortumab Jul (1L mUC; Europe) vedotin/ PADCEV NMPA D

  12. Slide 12: Zolbetuximab / VYLOY: Latest Status

    ZOLBETUXIMAB / VYLOY: LATEST STATUS 12 Pursuing product value maximization as the first-in-class anti-CLDN18.2 treatment Geography Progressing toward global launch (G/GEJ cancer) Launched on Jun 12 Resubmission acknowledged on May 30 (PDUFA date: Nov 9) Positive CHMP opinion received on Jul 26 Regul

  13. Slide 13: Progress in Focus Area Approach: Current Status of Projects in Clinical Trial

    PROGRESS IN FOCUS AREA APPROACH: 13 CURRENT STATUS OF PROJECTS IN CLINICAL TRIAL (Blue: Updates since the last financial results announcement) Primary Focus Biology/Modality/Technology Project Mechanism of Action Current status Phase 1 study ongoing. Checkpoint ASP1570 DGKζ inhibitor Modality Initia

  14. Slide 14: Q1/FY2024 Progress

    Q1/FY2024 PROGRESS 14 Solid start toward achieving the FY2024 initial forecast Major Progress Low 20% level 30% Aspirational state • Robust growth of Strategic Brands notably ~¥500B driven by PADCEV and IZERVAY Core OP margin 15.2% • PADCEV positive CHMP opinion (1L mUC) • VYLOY successful launch in

  15. Slide 15: Appendix

    APPENDIX

  16. Slide 16: XTANDI and Strategic Brands: Potential Peak Sales

    XTANDI AND STRATEGIC BRANDS: POTENTIAL PEAK SALES 16 (AS OF JUL 2024) Potential Peak Sales Brand (Global, billions of yen) XTANDI (enzalutamide) over 700.0 * PADCEV (enfortumab vedotin) 400.0 – 500.0 IZERVAY (avacincaptad pegol) 200.0 – 400.0 VEOZAH (fezolinetant) 150.0 – 250.0 VYLOY (zolbetuximab)

  17. Slide 17: Q1/FY2024 Actual: FX Rate

    Q1/FY2024 ACTUAL: FX RATE 17 Average rate for the period Currency Q1/FY2023 Q1/FY2024 Change USD 137 yen 156 yen +19 yen EUR 150 yen 168 yen +18 yen <Impact of exchange rate on financial results>  45.4 billion yen increase in revenue, 11.6 billion yen increase in core OP

  18. Slide 18: FY2024 Forecast: FX Rate & FX Sensitivity

    FY2024 FORECAST: FX RATE & FX SENSITIVITY 18 Exchange rate FY2023 FY2024 FCST Change Average for the period USD 145 yen 145 yen - EUR 157 yen 155 yen -2 yen Estimated FX sensitivity of FY2024 forecasts by 1 yen depreciation Average rate Currency 1 yen depreciation from assumption Revenue Core OP USD

  19. Slide 19: Balance Sheet & Cash Flow Highlights

    BALANCE SHEET & CASH FLOW HIGHLIGHTS 19 (billion yen) FY2023 end Jun 30, 2024 Total assets 3,569.6 3,735.5 Cash and cash equivalents 335.7 302.9 Total equity attributable to owners of the parent 1,596.0 1,676.4 Equity ratio (%) 44.7% 44.9% (billion yen) Q1/FY2023 Q1/FY2024 Cash flows from operating

  20. Slide 20: Balance of Bonds and Borrowings Highlights

    BALANCE OF BONDS AND BORROWINGS HIGHLIGHTS 20 （billion yen） FY2023 end Jun 30, 2024 Balance of bonds and borrowings 920.0 992.7 Non-current liabilities 447.7 443.1 Bonds 250.0 250.0 Long-term borrowings 197.7 193.1 Current liabilities 472.3 549.6 Commercial papers 285.0 325.7 Short-term borrowings 1

  21. Slide 21: Main Intangible Assets (as of Jun 30, 2024)

    MAIN INTANGIBLE ASSETS (AS OF JUN 30, 2024) 21 Bil. yen Foreign currency* AT132 17.5 $109M AT845 11.7 $73M Other gene therapy related program** 61.1 $380M Gene therapy related technology** 74.1 $461M VEOZAH 97.9 €545M EVRENZO 4.1 - VYLOY 63.6 €489M IZERVAY （US） 752.0 $4,676M IZERVAY (Ex-US） 176.9 $1

  22. Slide 22: Capital Allocation

    CAPITAL ALLOCATION 22 1 Top priority is investment 2 Raise dividend level aligned 3 Flexibly execute share for business growth with profit / cashflow plan and buyback by excess cash actual performance throughout CSP2021 period Aiming for higher level of dividends increase during CSP2021 aligned with

  23. Slide 23: Core Basis Performance: Changes in Definitions and Context

    CORE BASIS PERFORMANCE: CHANGES IN DEFINITIONS AND CONTEXT 23 Introduce New definition of core-based performance from FY2024 Financial Results Financial Results Financial Results （Full basis） （Old definition： Core basis） （New definition： Core basis） Revenue Certain items reported in financial result

  24. Slide 24: Enfortumab Vedotin (EV): Study Data in Solid Tumors Other Than UC (EV-202)

    ENFORTUMAB VEDOTIN (EV): 24 STUDY DATA IN SOLID TUMORS OTHER THAN UC (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 cell lung cancer 43 2

  25. Slide 25: Robust Pipeline of Astellas

    ROBUST PIPELINE OF ASTELLAS 25 Phase 1 Phase 2 Phase 3 Submitted/Filed enfortumab vedotin enfortumab vedotin enfortumab vedotin enfortumab vedotin (NMIBC) (Other solid tumors) (MIBC) (mUC previously untreated: Europe, Japan, China; mUC pretreated: China) gilteritinib zolbetuximab gilteritinib (Newly

  26. Slide 26: Progress in Overall Pipeline

    PROGRESS IN OVERALL PIPELINE 26 Phase 1 Entry to Approval since the Last Financial Results Announcement Phase 1 Entry Phase 2 Entry Phase 3 Entry Filing Approval ASP5502 zolbetuximab zolbetuximab enzalutamide Primary Sjogren’s syndrome Gastric and Gastric and Metastatic hormone-sensitive gastroesoph

  27. Slide 27: XTANDI and Strategic Brands: Status Update

    XTANDI AND STRATEGIC BRANDS: STATUS UPDATE 27 (Blue: Updates since the last financial results announcement) Project / Product Indication Current status enzalutamide/ M1 CSPC • Approved in China in Jun 2024 XTANDI • Previously untreated (first line): sNDA accepted in Japan in Jan 2024. sBLA accepted

  28. Slide 28: Enzalutamide (1/2): Androgen Receptor Inhibitor

    ENZALUTAMIDE (1/2): ANDROGEN RECEPTOR INHIBITOR 28 (Blue: Updates since the last financial results announcement) US/Europe/ Localized Prostate Cancer Castration-Sensitive Castration-Resistant Prostate Cancer Prostate Cancer Japan ARCHES M1 CSPC newly-diagnosed PREVAIL AFFIRM M1 CSPC M1 CRPC M1 CRPC

  29. Slide 29: Enzalutamide (2/2): Phase 3 Study Data by Disease Stage

    ENZALUTAMIDE (2/2): PHASE 3 STUDY DATA BY DISEASE STAGE 29 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

  30. Slide 30: Enfortumab Vedotin (1/4): Nectin-4 Targeted ADC Overall UC Program

    ENFORTUMAB VEDOTIN (EV) (1/4): NECTIN-4 TARGETED ADC 30 OVERALL UC PROGRAM Early stage - Disease stage of urothelial cancer - Late stage NMIBC MIBC mUC Stages 0a-1 Stages 2 and 3 Stage 4 Previously Platinum and Patient BCG- PD-1/L1 inhibitor RC-eligible untreated PD-1/L1 inhibitor treatment unrespon

  31. Slide 31: Enfortumab Vedotin (2/4): Clinical Studies

    ENFORTUMAB VEDOTIN (EV) (2/4): CLINICAL STUDIES 31 (Blue: Updates since the last financial results announcement) For urothelial cancer mUC, Platinum and PD-1/L1 inhibitor pretreated; sBLA (to convert regular approval) approved in US in Jul 2021. P3: EV-301 NCT03474107 n=608 EV mono vs. Chemo Approve

  32. Slide 32: Enfortumab Vedotin (3/4): Study Data by Disease Stage of UC

    ENFORTUMAB VEDOTIN (EV) (3/4): 32 STUDY DATA BY DISEASE STAGE OF UC 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

  33. Slide 33: Enfortumab Vedotin (4/4): Future Outlook

    ENFORTUMAB VEDOTIN (EV) (4/4): FUTURE OUTLOOK 33  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 will provide further growth potential <Already approved / pivotal phase>

  34. Slide 34: Gilteritinib: FLT3 Inhibitor

    GILTERITINIB: FLT3 INHIBITOR 34 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

  35. Slide 35: Zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody

    ZOLBETUXIMAB: ANTI-CLAUDIN 18.2 MONOCLONAL ANTIBODY 35 (Blue: Updates since the last financial results announcement) Target: Claudin 18.2 Gastric and GEJ adenocarcinoma  Claudin is a major structural component of tight junctions  Metastatic gastric cancer is an area of significant unmet and seals

  36. Slide 36: Fezolinetant: NK3 Receptor Antagonist

    FEZOLINETANT: NK3 RECEPTOR ANTAGONIST 36 VMS has a significant negative impact on QoL Women’s Health Initiative (WHI) Study 2  Physical symptoms include hot flashes and night sweats, which can  Initial data analyses showed an association between chronic HRT use and impact sleep. increased risk of

  37. Slide 37: Avacincaptad Pegol (ACP): Complement C5 Inhibitor / Pegylated RNA Aptamer

    AVACINCAPTAD PEGOL (ACP): 37 COMPLEMENT C5 INHIBITOR / PEGYLATED RNA APTAMER Geographic atrophy (GA) Characteristics of ACP  Advanced form of dry age-related macular degeneration  Pegylated RNA aptamer (Chemically synthesized) (AMD)  ACP inhibits complement C5, and slows inflammation and cell  G

  38. Slide 38: On the Forefront of Healthcare Change

    ON THE FOREFRONT OF HEALTHCARE CHANGE

Astellas Pharma — Q1 2024 Earnings Presentation on 6ix