Astellas Pharma Inc. · TSE:4503
Astellas Pharma — Q3 2024 Earnings Presentation
47 slides from Astellas Pharma's earnings presentation, Feb 4, 2025
Slide 1: Q3 YTD/FY2024 Financial Results
Q3 YTD/FY2024 Financial Results Atsushi Kitamura Chief Financial Officer (CFO) Astellas Pharma Inc. February 4, 2025
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
Slide 3: Agenda
Agenda 3 Q3 YTD/FY2024 Consolidated Financial Results I FY2024 Revised Forecast II Initiatives for Sustainable Growth
Slide 4: Q3 YTD/FY2024 Financial Results: Key Message
Q3 YTD/FY2024 Financial Results: Key Message 4 Revenue ⚫ Increased significantly YoY (+22%) ⚫ Strategic Brands: Expanded to over 240.0 bil. yen (+140.0 bil. yen YoY) SG&A expenses* ⚫ SG&A ratio improved by 4.0ppt YoY, driven by robust progress of SMT (Sustainable Margin Transformation) Core operatin
Slide 5: Q3 YTD/FY2024 Financial Results
Q3 YTD/FY2024 Financial Results 5 Q3 YTD Q3 YTD Change FY2024 (billion yen) Change FX impact (YoY) FY2023 FY2024 (%) Latest FCST Revenue 1,189.1 1,453.0 +264.0 +22.2% 1,900.0 +66.3 Cost of sales 219.3 272.3 +53.1 +24.2% 345.0 +7.6 SG&A expenses 547.0 631.7 +84.8 +15.5% 845.0 +31.7 US XTANDI co-pro f
Slide 6: Q3 YTD/FY2024 Financial Results: XTANDI and Strategic Brands
Q3 YTD/FY2024 Financial Results: XTANDI and Strategic Brands 6 XTANDI: US performance exceeded expectations, while other regions expanded as expected (billion yen) Q3 YTD/FY2024 YoY FY2024 FCST* ✓ Strong US growth driven by EMBARK impact (M0 CSPC) 703.1 +143.1 (+26%) 909.9 ✓ Upward revision of FCST
Slide 7: Business Update: PADCEV, IZERVAY, VYLOY
Business Update: PADCEV, IZERVAY, VYLOY 7 Global sales driven by 1L mUC US business entering a robust growth phase Encouraging uptake, expect further growth • Strong quarterly global growth driven by ex-US, • Q3 sales affected by temporary impact from CRL • Approved in 38 countries, launched in 9 co
Slide 8: Q3 YTD/FY2024 Financial Results: SG&A and R&D Expenses
Q3 YTD/FY2024 Financial Results: SG&A and R&D Expenses 8 ⚫ Robust progress of SMT initiatives toward the FY2024 target of 40.0 bil. yen in cost optimization ⚫ SG&A ratio improved to 29.7% (-4.0ppt YoY) Core basis: YoY comparison and ratio to revenue Cost Items YoY change Ratio to Revenue (billion ye
Slide 9: FY2024 Revised Forecast
FY2024 Revised Forecast 9 ⚫ Core basis: Upward revision based on robust progress of revenue and SMT ⚫ Full basis: Downward revision of profit mainly due to impairment losses on IZERVAY (Ex-US) and AT466 ⚫ No change in dividend forecast of 74 yen Exchange rates for Latest forecast: 153 yen/USD, 164 y
Slide 10: Agenda
Agenda 10 Q3 YTD/FY2024 Consolidated Financial Results I FY2024 Revised Forecast II Initiatives for Sustainable Growth
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) Approval Approval (1L mUC; China) enfortumab vedotin/ Aug (2L+ mUC; China, 1
Slide 12: avacincaptad pegol / IZERVAY: Latest Status
avacincaptad pegol / IZERVAY: Latest Status 12 Regulatory activities are in progress globally to maximize product potential US EU Japan Revised sNDA for label Individual discussions with NDA submission for update accepted in Jan regulatory authorities in major Conditional Approval based ✓ PDUFA date
Slide 13: Progress in Focus Area Approach: Current Status of Programs in Clinical Trial
Progress in Focus Area Approach: 13 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 study ongoing ASP2138 Anti-CLD
Slide 14: Improvement of R&D Productivity
Improvement of R&D Productivity 14 Strategically reviewed R&D portfolio with discipline to allocate resource to prioritized assets Strategic review of Prioritized investment Sustainable growth R&D portfolio • In-depth analysis to assess • Increased investment in PF Focus on prioritized PFs probabili
Slide 15: Progress in Q3 YTD/FY2024 and Latest Outlook
Progress in Q3 YTD/FY2024 and Latest Outlook 15 Entering a fundamental growth phase to overcome XTANDI LOE and pursue further growth Q3 Progress Three Enterprise Priorities • Significant growth of Strategic Sustainable Margin Transformation Brands (+¥140B YoY) Low 20% level 30% • Company-wide cost o
Slide 16: Upcoming Event: Sustainability Meeting 2024
Upcoming Event 16 Sustainability Meeting 2024 ➢ Feb 21st 2025, 10:00-11:30 (JST)
Slide 17: Appendix
Appendix Wastellas
Slide 18: XTANDI and Strategic Brands: Potential Peak Sales (as of Feb 2025)
XTANDI and Strategic Brands: Potential Peak Sales (as of Feb 2025) 18 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)
Slide 19: Q3 YTD/FY2024 Actual: FX Rate
Q3 YTD/FY2024 Actual: FX Rate 19 Average rate for the period Currency Q3 YTD/FY2023 Q3 YTD/FY2024 Change USD 143 yen 152 yen +9 yen EUR 155 yen 165 yen +9 yen <Impact of exchange rate on financial results> ⚫ Revenue: +66.3 billion yen ⚫ Core OP: +17.1 billion yen
Slide 20: FY2024 Forecast: FX Rate & FX Sensitivity
FY2024 Forecast: FX Rate & FX Sensitivity 20 Exchange rate FY2024 FY2024 Change Average for the period Previous FCST Latest FCST USD 149 yen 153 yen +4 yen EUR 160 yen 164 yen +4 yen Forecast rates for Q4: 155 yen/USD, 163 yen/EUR Estimated FX sensitivity for Q4 (Jan-Mar 2025) of FY2024 latest forec
Slide 21: Balance Sheet & Cash Flow Highlights
Balance Sheet & Cash Flow Highlights 21 (billion yen) FY2023 end Dec 31, 2024 Total assets 3,569.6 3,451.6 Cash and cash equivalents 335.7 179.9 Total equity attributable to owners of the parent 1,596.0 1,493.8 Equity ratio (%) 44.7% 43.3% (billion yen) Q3 YTD/FY2023 Q3 YTD/FY2024 Cash flows from op
Slide 22: Balance of Bonds and Borrowings Highlights
Balance of Bonds and Borrowings Highlights 22 （billion yen） Sep 30, 2024 Dec 31, 2024 Balance of bonds and borrowings 927.5 915.4 Non-current liabilities 620.2 585.5 Bonds 350.0 320.0 Long-term borrowings 270.2 265.5 Current liabilities 307.3 329.9 Commercial papers 164.8 179.8 Short-term borrowings
Slide 23: Main Intangible Assets (as of Dec 31, 2024)
Main Intangible Assets (as of Dec 31, 2024) 23 Bil. yen Foreign currency* AT132 17.1 $109M AT845 11.4 $73M Gene therapy related technology** 69.0 $439M VEOZAH 91.0 €524M VYLOY 61.0 €470M IZERVAY （US） 687.0 $4,371M IZERVAY (Ex-US） 54.2 $345M VEOZAH: Approved as “VEOZA” in ex-US *VEOZAH, VYLOY: foreig
Slide 24: Capital Allocation
Capital Allocation 24 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 25: Core Basis Performance: Changes in Definitions and Context
Core Basis Performance: Changes in Definitions and Context 25 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 26: Maximize Potential of Strategic Brands
Maximize Potential of Strategic Brands 26 Accelerate growth of Strategic Brands by new operating model and LCM Potential contribution Data readout timing PADCEV Three Enterprise Priorities MIBC from LCM (registrational study) Sustainable Margin Transformation VYLOY XOSPATA • Company-wide cost optimi
Slide 27: Advance Focus Area Approach
Advance Focus Area Approach 27 ⚫ Focus on prioritized Primary Focuses and increase pipeline value based on PoC judgment of flagship programs ⚫ Continue exploratory research at the frontier with discipline, to generate new programs for future growth Three Enterprise Priorities “Divergence” phase Tran
Slide 28: Sustainable Margin Transformation
Sustainable Margin Transformation 28 ⚫ Company-wide cost optimization of 120-150 billion yen before XTANDI LOE ⚫ Fund growth investment and profit improvement Three Enterprise Priorities Core OP margin Sustainable Margin Transformation Sustainable Margin Transformation Low 20% level 30% • Company-wi
Slide 29: Lifecycle Management of Strategic Brands
Lifecycle Management of Strategic Brands 29 (Blue: Updates since the last financial results announcement) Product Indication Current status Next milestone MIBC Phase 3 EV-303 & EV-304 studies ongoing TLR anticipated for FY2025 NMIBC Phase 1 EV-104 study ongoing TLR anticipated for FY2025 2L+: Next s
Slide 30: Overview of Primary Focus Flagship Programs (1/2)
Overview of Primary Focus Flagship Programs (1/2) 30 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
Slide 31: Overview of Primary Focus Flagship Programs (2/2)
Overview of Primary Focus Flagship Programs (2/2) 31 AT845 (Genetic Regulation) ASP7317 (Blindness & Regeneration) Recombinant AAV8 expressing hGAA gene specially in muscle Replacement therapy with retinal pigment epithelial cells ⚫ Target disease: Pompe disease aiming to maintain and restore visual
Slide 32: Robust Pipeline of Astellas
Robust Pipeline of Astellas 32 Phase 1 Phase 2 Phase 3 enfortumab vedotin enfortumab vedotin enfortumab vedotin (NMIBC) (Other solid tumors) (MIBC) ASP1570 gilteritinib gilteritinib (Newly diagnosed AML, HIC-ineligible) (Earlier-stage AML, pediatric use) ASP2138 zolbetuximab fezolinetant (Pancreatic
Slide 33: Progress in Overall Pipeline
Progress in Overall Pipeline 33 Phase 1 Entry to Approval Since the Last Financial Results Announcement Phase 1 Entry Phase 2 Entry Phase 3 Entry Filing Approval gilteritinib enfortumab vedotin Newly diagnosed acute Locally advanced or myeloid leukemia metastatic urothelial cancer: (ineligible for h
Slide 34: Strategic Brands: Status Update
Strategic Brands: Status Update 34 (Blue: Updates since the last financial results announcement) Generic / Brand name Indication Current status Metastatic urothelial cancer • Previously untreated (first line): Approved in China in Jan 2025 enfortumab vedotin / Muscle-invasive bladder cancer • Phase
Slide 35: enzalutamide (1/2): Androgen Receptor Inhibitor
enzalutamide (1/2): Androgen Receptor Inhibitor 35 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
Slide 36: enzalutamide (2/2): Phase 3 Study Data by Disease Stage
enzalutamide (2/2): Phase 3 Study Data by Disease Stage 36 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 37: enfortumab vedotin (EV) (1/6): Nectin-4 Targeted ADC
enfortumab vedotin (EV) (1/6): Nectin-4 Targeted ADC 37 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 38: enfortumab vedotin (EV) (2/6): Clinical Studies
enfortumab vedotin (EV) (2/6): Clinical Studies 38 (Blue: Updates since the last financial results announcement) For urothelial cancer mUC, Previously untreated, Platinum-eligible; Approved in US in Dec 2023, in Europe in Aug 2024, in P3: EV-302 NCT04223856 n=886 EV + Pembro vs. Chemo Japan in Sep 2
Slide 39: enfortumab vedotin (EV) (3/6): Study Data by Disease Stage of UC
enfortumab vedotin (EV) (3/6): 39 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 40: enfortumab vedotin (EV) (4/6): Study Data in 1L mUC (EV-302)
enfortumab vedotin (EV) (4/6): Study Data in 1L mUC (EV-302) 40 Statistically significant and clinically meaningful improvement over chemotherapy with nearly doubled mOS and mPFS <Progression-free survival> <Overall survival> 78.2% 69.5% 50.7% 61.4% 43.9% EV + Pembro EV + Pembro 44.7% Chemo 21.6% Ch
Slide 41: enfortumab vedotin (EV) (5/6): Study Data in Solid Tumors Other than UC
enfortumab vedotin (EV) (5/6): 41 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 cance
Slide 42: enfortumab vedotin (EV) (6/6): Future Outlook
enfortumab vedotin (EV) (6/6): Future Outlook 42 ⚫ 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 43: gilteritinib: FLT3 Inhibitor
gilteritinib: FLT3 Inhibitor 43 (Blue: Updates since the last financial results announcement) 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 VICER
Slide 44: zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody
zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody 44 (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
Slide 45: fezolinetant: NK3 receptor antagonist
fezolinetant: NK3 receptor antagonist 45 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 between chronic HRT use and impact sleep. increased risk of c
Slide 46: avacincaptad pegol (ACP): Complement C5 Inhibitor / Pegylated RNA Aptamer
avacincaptad pegol (ACP): 46 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
Slide 47: 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