Astellas Pharma Inc. · TSE:4503
Astellas Pharma — FY2023 Earnings Presentation
49 slides from Astellas Pharma's earnings presentation, Apr 25, 2024
Slide 1: FY2023 Financial Results Ended March 31, 2024
FY2023 FINANCIAL RESULTS ENDED MARCH 31, 2024 Naoki Okamura President and CEO Astellas Pharma Inc. April 25, 2024
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
Slide 3: Agenda
AGENDA 3 I FY2023 Consolidated Financial Results II Initiatives for Sustainable Growth FY2024 Forecast III CSP2021 Outlook CSP: Corporate Strategic Plan
Slide 4: FY2023 Financial Results: Overview
FY2023 FINANCIAL RESULTS: OVERVIEW 4 Revenue increased YoY. Exceeded the revised full-year forecast ⚫ XTANDI: Increased approx. +90.0 bil. yen YoY, contributed to the achievement of the full-year forecast ⚫ PADCEV, XOSPATA, VEOZAH, IZERVAY: Increased approx. +70.0 bil. yen YoY, Contributed to sales
Slide 5: FY2023 Financial Results
FY2023 FINANCIAL RESULTS 5 Change FY23 (billion yen) FY2022 FY2023 Change Achievement FX impact (YoY) (%) FCST Revenue 1,518.6 1,603.7 +85.1 +5.6% 1,562.0 102.7% +96.3 Cost of sales 288.4 292.5 +4.1 +1.4% +15.8 % of revenue 19.0% 18.2% -0.7 ppt SG&A expenses 630.3 740.1 +109.8 +17.4% 731.0 101.2% +4
Slide 6: FY2023 Financial Results: Main Products
FY2023 FINANCIAL RESULTS: MAIN PRODUCTS 6 Significant contribution to revenue expansion as growth drivers FY2023 Achievement (billion yen) FY2023 Act YoY FCST* against FCST ✓ Global sales exceeded the FCST revised upward in Q2 750.5 +89.3 （+14%） 719.8 104% ✓ Sales expanded in all regions, despite 10
Slide 7: FY2023 Financial Results: Cost Items
FY2023 FINANCIAL RESULTS: COST ITEMS 7 ⚫ SG&A: Increased YoY mainly due to the impact of Iveric Bio acquisition and investments in growth drivers Achieved more efficient cost management than expectation through timely assessment of resources (excl. FX impact) ⚫ R&D: On track Core basis: YoY comparis
Slide 8: Agenda
AGENDA 8 I FY2023 Consolidated Financial Results II Initiatives for Sustainable Growth FY2024 Forecast III CSP2021 Outlook CSP: Corporate Strategic Plan
Slide 9: Initiatives for Sustainable Growth: Overview of Quarterly Updates
INITIATIVES FOR SUSTAINABLE GROWTH: 9 OVERVIEW OF QUARTERLY UPDATES XTANDI and Strategic products ⚫ enzalutamide / XTANDI : Approval for M0 CSPC* indication (Europe) ⚫ enfortumab vedotin / PADCEV : Acceptance of application for 1L mUC (China) ⚫ zolbetuximab / VYLOY : Approval (Japan) ⚫ fezolinetant
Slide 10: XTANDI and Strategic Products: FY2023 Key Events
XTANDI AND STRATEGIC PRODUCTS: FY2023 KEY EVENTS 10 Achieved regulatory approval for VYLOY, VEOZAH, IZERVAY and indication expansion for XTANDI and PADCEV Q1 (Apr-Jun) Q2 (Jul-Sep) Q3 (Oct-Dec) Q4 (Jan-Mar) Acceptance Approval Approval enzalutamide/ (M0 CSPC*; US) (M0 CSPC*; US) (M0 CSPC*; Europe) A
Slide 11: Progress in Focus Area Approach: Current Status of Projects in Clinical Trial
PROGRESS IN FOCUS AREA APPROACH: 11 CURRENT STATUS OF PROJECTS IN CLINICAL TRIAL Primary Focus Biology/Modality/Technology Project Mechanism of Action Current status AT132 MTM1 gene ASPIRO study put on clinical hold by FDA in Sep 2021 Genetic Gene replacement (AAV) AT845 GAA gene Phase 1 study ongoi
Slide 12: Progress in Focus Area Approach: New Clinical Programs
PROGRESS IN FOCUS AREA APPROACH: NEW CLINICAL PROGRAMS 12 ASP2016 ASP2802 ASP4396 Recombinant AAV8 encoding human convertibleCAR-T comprised of autologous Protein degrader targeting KRAS G12D frataxin (FXN) gene T cells and MicAbody directed to CD20 mutant ⚫ Target disease: Cardiomyopathy ⚫ Target d
Slide 13: Review of CSP2021 So Far
REVIEW OF CSP2021 SO FAR 13 Progress / situation Performance Goal above or below original assumptions Counteractions • Iveric Bio acquisition 1. Revenue: ⚫ PADCEV EV-302 study • Product value maximization XTANDI and Strategic products ⚫ VEOZAH uptake through LCM (ex. PADCEV, VYLOY sales ¥1.2T in F
Slide 14: Agenda
AGENDA 14 I FY2023 Consolidated Financial Results II Initiatives for Sustainable Growth FY2024 Forecast III CSP2021 Outlook CSP: Corporate Strategic Plan
Slide 15: FY2024 Forecast: Background
FY2024 FORECAST: BACKGROUND 15 Balanced forecast between ambitious and achievable ✓ Updated VEOZAH’s sales outlook ✓ Factored in the impact of US mirabegron generic entry ✓ Significant growth of Strategic products (+120.0 bil. yen YoY) ✓ Change the definition of core basis to adequately represent pr
Slide 16: FY2024 Forecast: XTANDI, PADCEV, XOSPATA, VYLOY
FY2024 FORECAST: XTANDI, PADCEV, XOSPATA, VYLOY 16 PADCEV: Expect further significant growth in FY2024 / VYLOY: Expect global launch (billion yen) FY2024 FCST YoY (vs. FY2023) ✓ Expect global sales to be at the same level as FY2023, with ex-US regions offsetting the impact of the US IRA 757.0 +6.6 （
Slide 17: FY2024 Forecast: VEOZAH, IZERVAY
FY2024 FORECAST: VEOZAH, IZERVAY 17 VEOZAH: Peak sales updated by reviewing initial assumptions / IZERVAY: Expect significant growth in FY2024 FY2024 FCST YoY (vs. FY2023) FY2024 FCST YoY (vs. FY2023) 28.3 bil. yen +21.0 （+288%） 46.4 bil. yen +34.3 （+283%） <US> <US> ✓ Expect linear demand growth thr
Slide 18: XTANDI and Strategic Products: FY2024 Key Expected Events
XTANDI AND STRATEGIC PRODUCTS: FY2024 KEY EXPECTED EVENTS 18 Q1 (Apr-Jun) Q2 (Jul-Sep) Q3 (Oct-Dec) Q4 (Jan-Mar) enzalutamide/ NMPA Decision XTANDI (M1 CSPC; China) enfortumab vedotin/ NMPA Decision MHLW/EC Decision (2L+ mUC; China) (1L mUC; Japan, Europe) PADCEV Resubmission (US) FDA Decision (US)
Slide 19: Focus Area Approach: Outlook
FOCUS AREA APPROACH: OUTLOOK 19 ⚫ Expect PoC judgment in lead programs from each PF by end of FY2025 (GR: AT845, IO: ASP2138, BR: ASP7317, TPD: ASP3082) ⚫ Success of lead programs will enhance expectation for success of follow-on programs ⚫ Reform of R&D organization and operation will accelerate Po
Slide 20: Change in Definition of Core Basis from FY2024
CHANGE IN DEFINITION OF CORE BASIS FROM FY2024 20 <Background> ⚫ The acquisition of Iveric Bio (July 2023) made it difficult to adequately represent profitability under the old definition ⚫ The new definition of core basis better represents profitability and ensures comparability with global pharmac
Slide 21: FY2024 Forecast
FY2024 FORECAST 21 ⚫ Increase in revenue, mainly driven by growth of PADCEV, VEOZAH and IZERVAY (approx. +120.0 bil. yen) ⚫ Factored in the impact of US mirabegron generic entry, however, the decline in core OP margin is minimized to approx. 2 percentage points by thorough review of costs that will
Slide 22: CSP2021: Latest Outlook
CSP2021: LATEST OUTLOOK 22 While Performance Goals are challenging to achieve in FY2025, establish a structure to overcome XTANDI LOE Strategic products will significantly grow from FY2024 and contribute to profit expansion Low 20% level 30% Aspirational state ~¥500B Initiatives and milestones for f
Slide 23: Appendix
APPENDIX
Slide 24: XTANDI & XOSPATA: Business Update
XTANDI & XOSPATA: BUSINESS UPDATE 24 FY2023 performance in line with FCST upwardly revised in Q2 FY2023 Act YoY FY2023 Revised FCST* FY2024 FCST YoY (vs. FY2023) 750.5 bil. yen +89.3 (+14%) 719.8 104%** 757.0 bil. yen +6.6 （+1%） ✓ Global sales exceeded the FCST revised upward in Q2 ✓ Expect global s
Slide 25: PADCEV & VYLOY: Business Update
PADCEV & VYLOY: BUSINESS UPDATE 25 PADCEV near double growth achieved, expect further significant growth in FY2024. Expect VYLOY to launch globally FY2023 Act YoY FY2023 Revised FCST* FY2024 FCST YoY (vs. FY2023) 85.4 bil. yen +40.9 （+92%） 85.2 100%** 151.2 bil. yen +65.9 （+77%） ✓ Expect progressive
Slide 26: VEOZAH: Business Update
VEOZAH: BUSINESS UPDATE 26 Overall initiatives are progressing; however, demand trails expectations. Peak sales updated by reviewing initial assumptions FY2023 Act FY2023 Revised FCST* FY2024 FCST YoY (vs. FY2023) 7.3 bil. yen 7.1 102%** 28.3 bil. yen +21.0 （+288%） <US> <US> ✓ Expect linear demand g
Slide 27: IZERVAY: Business Update (US)
IZERVAY: BUSINESS UPDATE (US) 27 Encouraging performance since launch with accelerated momentum. Expect significant growth in FY2024 FY2023 Act FY2023 FCST* FY2024 FCST YoY (vs. FY2023) 12.1 bil. yen 11.0 110%** 46.4 bil. yen +34.3 （+283%） ✓ Sales exceeded expectations driven by accelerated momentum
Slide 28: FY2023 Actual: FX Rate
FY2023 ACTUAL: FX RATE 28 Average rate for the period Currency FY2022 FY2023 Change USD 135 yen 145 yen +9 yen EUR 141 yen 157 yen +16 yen <Impact of exchange rate on financial results> ⚫ 96.3 billion yen increase in revenue, 19.1 billion yen increase in core OP
Slide 29: FY2024 Forecast: FX Rate & FX Sensitivity
FY2024 FORECAST: FX RATE & FX SENSITIVITY 29 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* US
Slide 30: Balance Sheet & Cash Flow Highlights
BALANCE SHEET & CASH FLOW HIGHLIGHTS 30 (billion yen) FY2022 end FY2023 end Total assets 2,456.5 3,569.6 Cash and cash equivalents 376.8 335.7 Total equity attributable to owners of the parent 1,508.0 1,596.0 Equity ratio (%) 61.4% 44.7% (billion yen) FY2022 FY2023 Cash flows from operating activiti
Slide 31: Balance of Bonds and Borrowings Highlights
BALANCE OF BONDS AND BORROWINGS HIGHLIGHTS 31 （billion yen） FY2023 Dec end FY2023 end Balance of bonds and borrowings 871.0 920.0 Non-current liabilities 463.8 447.7 Bonds 250.0 250.0 Long-term borrowings 213.8 197.7 Current liabilities 407.2 472.3 Commercial papers 357.0 285.0 Short-term borrowings
Slide 32: Core Basis Performance: Changes in Definitions and Context
CORE BASIS PERFORMANCE: CHANGES IN DEFINITIONS AND CONTEXT 32 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
Slide 33: Main Intangible Assets (as of FY2023 End)
MAIN INTANGIBLE ASSETS (AS OF FY2023 END) 33 Bil. yen Foreign currency* AT132 16.4 USD 109M AT845 11.0 USD 73M Other gene therapy related program** 57.5 USD 380M Gene therapy related technology** 71.4 USD 472M VEOZAH 94.1 EUR 556M EVRENZO 4.3 - VYLOY 64.0 EUR 493M IZERVAY （US） 730.6 USD 4,828M IZERV
Slide 34: Capital Allocation
CAPITAL ALLOCATION 34 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
Slide 35: Robust Pipeline of Astellas
ROBUST PIPELINE OF ASTELLAS 35 Phase 1 Phase 2 Phase 3 Submitted/Filed enfortumab vedotin enfortumab vedotin enfortumab vedotin enzalutamide (NMIBC) (Other solid tumors) (MIBC) (M1 CSPC: China) gilteritinib zolbetuximab gilteritinib enfortumab vedotin (Newly diagnosed AML, HIC-ineligible) (Pancreati
Slide 36: Progress in Overall Pipeline
PROGRESS IN OVERALL PIPELINE 36 Phase 1 Entry to Approval since the Last Financial Results Announcement Phase 1 Entry Phase 2 Entry Phase 3 Entry Filing Approval ASP2016 fezolinetant enfortumab vedotin enzalutamide Cardiomyopathy associated Induced VMS in breast Locally advanced or High risk biochem
Slide 37: XTANDI and Strategic Products: Potential Peak Sales
XTANDI AND STRATEGIC PRODUCTS: POTENTIAL PEAK SALES 37 (AS OF APR 2024) Potential Peak Sales Product (Global, billions of yen) XTANDI (enzalutamide) over 700.0 PADCEV (enfortumab vedotin) 1 400.0 – 500.0 IZERVAY (avacincaptad pegol) 200.0 – 400.0 VEOZAH (fezolinetant) 150.0 – 250.0 XOSPATA (gilterit
Slide 38: XTANDI and Strategic Products: Status Update
XTANDI AND STRATEGIC PRODUCTS: STATUS UPDATE 38 (Red: Updates since the last financial results announcement) Project / Product Indication Current status enzalutamide/ M1 CSPC • NDA accepted in China in Sep 2023 XTANDI M0 CSPC with BCR at high risk for metastasis • Approved in Europe in Apr 2024 • Pr
Slide 39: Enzalutamide (1/2): Androgen Receptor Inhibitor
ENZALUTAMIDE (1/2): ANDROGEN RECEPTOR INHIBITOR 39 (Red: Updates since the last financial results announcement) US/Europe/ Castration-Sensitive Localized Prostate Cancer Castration-Resistant Prostate Cancer Prostate Cancer Japan ARCHES M1 CSPC newly-diagnosed PREVAIL AFFIRM M1 CSPC M1 CRPC M1 CRPC r
Slide 40: Enzalutamide (2/2): Phase 3 Study Data by Disease Stage
ENZALUTAMIDE (2/2): PHASE 3 STUDY DATA BY DISEASE STAGE 40 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
Slide 41: Enfortumab Vedotin (1/4): Nectin-4 Targeted ADC Overall UC Program
ENFORTUMAB VEDOTIN (EV) (1/4): NECTIN-4 TARGETED ADC 41 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
Slide 42: Enfortumab Vedotin (2/4): Clinical Studies
ENFORTUMAB VEDOTIN (EV) (2/4): CLINICAL STUDIES 42 (Red: 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 Approved
Slide 43: Enfortumab Vedotin (3/4): Study Data by Disease Stage of UC
ENFORTUMAB VEDOTIN (EV) (3/4): 43 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
Slide 44: Enfortumab Vedotin (4/4): Future Outlook
ENFORTUMAB VEDOTIN (EV) (4/4): FUTURE OUTLOOK 44 ⚫ 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>
Slide 45: Gilteritinib: FLT3 Inhibitor
GILTERITINIB: FLT3 INHIBITOR 45 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
Slide 46: Zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody
ZOLBETUXIMAB: ANTI-CLAUDIN 18.2 MONOCLONAL ANTIBODY 46 (Red: Updates since the last financial results announcement) Target: Claudin 18.2 Gastric and GEJ adenocarcinoma ⚫ Claudin is a major structural component of tight junctions ⚫ Target patient population: and seals intercellular space in epithelia
Slide 47: Fezolinetant: NK3 Receptor Antagonist
FEZOLINETANT: NK3 RECEPTOR ANTAGONIST 47 (Red: Updates since the last financial results announcement) 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
Slide 48: Avacincaptad Pegol (ACP): Complement C5 Inhibitor / Pegylated RNA Aptamer
AVACINCAPTAD PEGOL (ACP): 48 COMPLEMENT C5 INHIBITOR / PEGYLATED RNA APTAMER (Red: 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) ⚫ AC
Slide 49: On the Forefront of Healthcare Change
ON THE FOREFRONT OF HEALTHCARE CHANGE