Slide 1: Q2 YTD/FY2024 Financial Results
Q2 YTD/FY2024 FINANCIAL RESULTS Naoki Okamura President and CEO Astellas Pharma Inc. October 30, 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 Q2 YTD/FY2024 Consolidated Financial Results I FY2024 Revised Forecast II Initiatives for Sustainable Growth III Mid-term Initiatives and Latest Outlook
Slide 4: Q2 YTD/FY2024 Financial Results: Overview
Q2 YTD/FY2024 FINANCIAL RESULTS: OVERVIEW 4 Revenue ⚫ Increased YoY (+22%) ⚫ Strategic Brands: Expanded to over 150.0 bil. yen Significant growth of over 90.0 bil. yen YoY, progress exceeded expectations SG&A expenses* ⚫ Ratio to revenue improved by 3.2ppt YoY through continued cost management Core
Slide 5: Q2 YTD/FY2024 Financial Results
Q2 YTD/FY2024 FINANCIAL RESULTS 5 Q2 YTD Q2 YTD Change FY2024 (billion yen) Change FX impact (YoY) FY2023 FY2024 (%) Initial FCST Revenue 767.1 935.6 +168.5 +22.0% 1,650.0 +54.8 Cost of sales 143.4 173.8 +30.5 +21.3% 326.0 +6.7 SG&A expenses 347.5 406.4 +58.9 +17.0% 757.0 +25.9 US XTANDI co-pro fee
Slide 6: Q2 YTD/FY2024 Financial Results: XTANDI and Strategic Brands
Q2 YTD/FY2024 FINANCIAL RESULTS: XTANDI AND STRATEGIC BRANDS 6 XTANDI progress continues to be strong, driven primarily by the US FY2024 FY2024 (billion yen) Q2 YTD/FY2024 YoY Initial FCST* Revised FCST 859.7 ✓ US progress continues to be driven by EMBARK impact (M0 CSPC) and market growth +90.7 451
Slide 7: PADCEV: Business Update
PADCEV: BUSINESS UPDATE 7 Significant sales growth globally. Expect robust global growth momentum to continue moving forward FY2024 FY2024 Q2 YTD/FY2024 YoY Regional progress Initial FCST* Revised FCST vs. Initial FCST • US : Steady penetration of 1L mUC, with new patient share approaching 55% Globa
Slide 8: IZERVAY: Business Update (US)
IZERVAY: BUSINESS UPDATE (US) 8 Performance continues to exceed expectations, expect further sales growth from Q3 onward Q2 YTD/FY2024 YoY FY2024 FY2024 Progress through Q2 Initial FCST* Revised FCST ✓ Continues to exceed expectations, driven by higher-than-expected new patient share vs. Initial FCS
Slide 9: Q2 YTD/FY2024 Financial Results: SG&A and R&D Expenses
Q2 YTD/FY2024 FINANCIAL RESULTS: SG&A AND R&D EXPENSES 9 SG&A ratio to revenue improved by 3.2ppt YoY through continued cost management Core basis: YoY comparison and ratio to revenue Cost Items YoY change Ratio to Revenue (billion yen) YoY increase excl. FX impact: approx. +10.0 SG&A expenses +10.2
Slide 10: FY2024 Revised Forecast
FY2024 REVISED FORECAST 10 ⚫ Upward revision of revenue and core operating profit based on the robust Q2 YTD progress ⚫ Change from profit decline initial forecast to profit increase forecast Exchange rates for revised forecast: 149 yen/USD, 160 yen/EUR (Forecast rates Q3 onwards: 145 yen/USD, 155 y
Slide 11: Agenda
AGENDA 11 Q2 YTD/FY2024 Consolidated Financial Results I FY2024 Revised Forecast II Initiatives for Sustainable Growth III Mid-term Initiatives and Latest Outlook
Slide 12: Initiatives for Sustainable Growth: Overview of Quarterly Updates
INITIATIVES FOR SUSTAINABLE GROWTH: 12 OVERVIEW OF QUARTERLY UPDATES Strategic Brands ⚫ enfortumab vedotin / PADCEV : Approval for 1L mUC (Europe, Japan) and 2L+ mUC (China) ⚫ zolbetuximab / VYLOY : Approval (Europe, US) ⚫ avacincaptad pegol / IZERVAY: Withdrawal of Marketing Authorization Applicati
Slide 13: XTANDI and Strategic Brands: FY2024 Key Expected Events
XTANDI AND STRATEGIC BRANDS: FY2024 KEY EXPECTED EVENTS 13 (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 enfortumab (2L+ mUC; China, 1L mUC; Europe) vedotin/ Aug PADCEV App
Slide 14: Progress in Focus Area Approach: Programs in Clinical Trial
PROGRESS IN FOCUS AREA APPROACH: 14 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 Phase 1 study ongoing. Checkpoint ASP1570 DGKζ inhibitor Initial data pr
Slide 15: Agenda
AGENDA 15 Q2 YTD/FY2024 Consolidated Financial Results I FY2024 Revised Forecast II Initiatives for Sustainable Growth III Mid-term Initiatives and Latest Outlook
Slide 16: Overview of Ongoing Initiatives and Latest Outlook
OVERVIEW OF ONGOING INITIATIVES AND LATEST OUTLOOK 16 Accelerate Three Enterprise Priorities to overcome XTANDI LOE and pursue further growth Three Enterprise Priorities Robust Q2 Progress Sustainable Margin Transformation • Significant growth of Strategic Low 20% level 30% • Company-wide cost optim
Slide 17: Maximize Potential of Strategic Brands
MAXIMIZE POTENTIAL OF STRATEGIC BRANDS 17 Accelerate growth of Strategic Brands by new operating model and LCM Potential contribution Three Enterprise Priorities from LCM Data readout timing VYLOY PADCEV XOSPATA Sustainable Margin Transformation (registrational study) Pancreatic cancer MIBC Untreate
Slide 18: Advance Focus Area Approach
ADVANCE FOCUS AREA APPROACHPotential contribution 18 from LCM ⚫ 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 Pri
Slide 19: Sustainable Margin Transformation
SUSTAINABLE MARGIN TRANSFORMATION 19 ⚫ 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 20: To Overcome XTANDI LOE and Pursue Further Growth
TO OVERCOME XTANDI LOE AND PURSUE FURTHER GROWTH 20 Three Enterprise Priorities Sustainable Margin Transformation Maximize potential of Strategic Brands, accelerate further growth with LCM contribution • Company-wide cost optimization Low 20% level 30% before XTANDI LOE Core OP margin • Fund growth
Slide 21: Appendix
APPENDIX
Slide 22: XTANDI and Strategic Brands: Potential Peak Sales
XTANDI AND STRATEGIC BRANDS: POTENTIAL PEAK SALES 22 (AS OF OCT 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)
Slide 23: Q2 YTD/FY2024 Actual: FX Rate
Q2 YTD/FY2024 ACTUAL: FX RATE 23 Average rate for the period Currency Q2 YTD/FY2023 Q2 YTD/FY2024 Change USD 141 yen 152 yen +11 yen EUR 153 yen 166 yen +12 yen <Impact of exchange rate on financial results> ⚫ Revenue: +54.8 billion yen ⚫ Core OP: +13.7 billion yen
Slide 24: FY2024 Forecast: FX Rate & FX Sensitivity
FY2024 FORECAST: FX RATE & FX SENSITIVITY 24 Exchange rate FY2024 FY2024 Change Average for the period Initial FCST Revised FCST USD 145 yen 149 yen +4 yen EUR 155 yen 160 yen +5 yen Forecast rates Q3 onwards: 145 yen/USD, 155 yen/EUR Estimated FX sensitivity (Q3 onwards) of FY2024 revised forecasts
Slide 25: Balance Sheet & Cash Flow Highlights
BALANCE SHEET & CASH FLOW HIGHLIGHTS 25 (billion yen) FY2023 end Sep 30, 2024 Total assets 3,569.6 3,462.2 Cash and cash equivalents 335.7 293.0 Total equity attributable to owners of the parent 1,596.0 1,529.8 Equity ratio (%) 44.7% 44.2% (billion yen) Q2 YTD/FY2023 Q2 YTD/FY2024 Cash flows from op
Slide 26: Balance of Bonds and Borrowings Highlights
BALANCE OF BONDS AND BORROWINGS HIGHLIGHTS 26 （billion yen） Jun 30, 2024 Sep 30, 2024 Balance of bonds and borrowings 992.7 927.5 Non-current liabilities 443.1 620.2 Bonds 250.0 350.0 Long-term borrowings 193.1 270.2 Current liabilities 549.6 307.3 Commercial papers 325.7 164.8 Short-term borrowings
Slide 27: Main Intangible Assets (as of Sep 30, 2024)
MAIN INTANGIBLE ASSETS (AS OF SEP 30, 2024) 27 Bil. yen Foreign currency* AT132 15.6 $109M AT845 10.4 $73M Other gene therapy related program** 55.1 $384M Gene therapy related technology** 64.6 $450M VEOZAH 86.8 €535M VYLOY 62.3 €480M IZERVAY （US） 649.7 $4,523M IZERVAY (Ex-US） 158.0 $1,100M VEOZAH:
Slide 28: Capital Allocation
CAPITAL ALLOCATION 28 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 29: Core Basis Performance: Changes in Definitions and Context
CORE BASIS PERFORMANCE: CHANGES IN DEFINITIONS AND CONTEXT 29 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 30: Lifecycle Management of Strategic Brands
LIFECYCLE MANAGEMENT OF STRATEGIC BRANDS 30 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 step under discussion (Under discussion) Head and neck cancer 1
Slide 31: Overview of Primary Focus Flagship Programs (1/2)
OVERVIEW OF PRIMARY FOCUS FLAGSHIP PROGRAMS (1/2) 31 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 32: Overview of Primary Focus Flagship Programs (2/2)
OVERVIEW OF PRIMARY FOCUS FLAGSHIP PROGRAMS (2/2) 32 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 33: Collaboration with AviadoBio
COLLABORATION WITH AVIADOBIO 33 Potential expansion of portfolio in Primary Focus Gene Therapy Overview of agreement AVB-101 ⚫ Exclusive option and license agreement for AVB-101 ⚫ AAV-based gene therapy to deliver human progranulin ✓ Option to receive a worldwide exclusive license for gene the devel
Slide 34: Robust Pipeline of Astellas
ROBUST PIPELINE OF ASTELLAS 34 Phase 1 Phase 2 Phase 3 Submitted/Filed enfortumab vedotin enfortumab vedotin enfortumab vedotin enfortumab vedotin (NMIBC) (Other solid tumors) (MIBC) (mUC previously untreated: China) gilteritinib zolbetuximab gilteritinib zolbetuximab (Newly diagnosed AML, HIC-ineli
Slide 35: Progress in Overall Pipeline
PROGRESS IN OVERALL PIPELINE 35 Phase 1 Entry to Approval since the Last Financial Results Announcement Phase 1 Entry Phase 2 Entry Phase 3 Entry Filing Approval enfortumab vedotin Locally advanced or metastatic urothelial cancer after prior treatment with platinum-containing chemotherapy and PD-1 o
Slide 36: Strategic Brands: Status Update
STRATEGIC BRANDS: STATUS UPDATE 36 (Blue: Updates since the last financial results announcement) Generic / Brand name Indication Current status • Previously untreated (first line): Approved in Europe in Aug 2024, in Japan in Sep 2024 Metastatic urothelial cancer • Pretreated: Approved in China in Au
Slide 37: Enzalutamide (1/2): Androgen Receptor Inhibitor
ENZALUTAMIDE (1/2): ANDROGEN RECEPTOR INHIBITOR 37 Localized Prostate Cancer Castration-Sensitive Castration-Resistant Prostate Cancer Prostate Cancer ARCHES M1 CSPC newly-diagnosed PREVAIL AFFIRM M1 CSPC M1 CRPC M1 CRPC recurrent (1st line) (2nd line+) Local Therapy PSA Initial Surgery, Radiation R
Slide 38: Enzalutamide (2/2): Phase 3 Study Data by Disease Stage
ENZALUTAMIDE (2/2): PHASE 3 STUDY DATA BY DISEASE STAGE 38 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 39: Enfortumab Vedotin (1/6): Nectin-4 Targeted ADC Overall UC Program
ENFORTUMAB VEDOTIN (EV) (1/6): NECTIN-4 TARGETED ADC 39 OVERALL UC PROGRAM (Blue: Updates since the last financial results announcement) 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 inhibi
Slide 40: Enfortumab Vedotin (2/6): Clinical Studies
ENFORTUMAB VEDOTIN (EV) (2/6): CLINICAL STUDIES 40 (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 41: Enfortumab Vedotin (3/6): Study Data by Disease Stage of UC
ENFORTUMAB VEDOTIN (EV) (3/6): 41 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 42: Enfortumab Vedotin (4/6): Study Data in 1L mUC (EV-302)
ENFORTUMAB VEDOTIN (EV) (4/6): STUDY DATA IN 1L MUC (EV-302) 42 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 43: Enfortumab Vedotin (5/6): Study Data in Solid Tumors Other Than UC
ENFORTUMAB VEDOTIN (EV) (5/6): 43 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 44: Enfortumab Vedotin (6/6): Future Outlook
ENFORTUMAB VEDOTIN (EV) (6/6): 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 (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 ⚫ Five-year survival rate is ~6% for metastatic gastric and seals inte
Slide 47: Fezolinetant: NK3 Receptor Antagonist
FEZOLINETANT: NK3 RECEPTOR ANTAGONIST 47 (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, which can ⚫ Initial data analyses showed an association
Slide 48: Avacincaptad Pegol (ACP): Complement C5 Inhibitor
AVACINCAPTAD PEGOL (ACP): 48 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 49: On the Forefront of Healthcare Change
ON THE FOREFRONT OF HEALTHCARE CHANGE