Slide 1: Q3/FY2023 Financial Results
Q3/FY2023 FINANCIAL RESULTS ENDED DECEMBER 31, 2023 Atsushi Kitamura Chief Financial Officer (CFO) Astellas Pharma Inc. February 5, 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 Q3/FY2023 Consolidated Financial Results I FY2023 Revised Forecasts II Initiatives for Sustainable Growth
Slide 4: Q3/FY2023 Financial Results: Overview
Q3/FY2023 FINANCIAL RESULTS: OVERVIEW 4 Revenue increased YoY, however, behind the full-year forecast XTANDI & XOSPATA: In line with the full-year forecast revised upward in Q2 PADCEV: In line with the full-year forecast revised significantly upward in Q2 Potential peak sales revised upward inco
Slide 5: Q3/FY2023 Financial Results
Q3/FY2023 FINANCIAL RESULTS 5 Change FY23 (billion yen) Q3/FY22 Q3/FY23 Change FX impact (YoY) (%) FCST Revenue 1,164.4 1,189.1 +24.7 +2.1% 1,608.0 +58.8 bil. yen Cost of sales 226.1 219.3 -6.8 -3.0% +10.2 bil. yen % of revenue 19.4% 18.4% -1.0 ppt SG&A expenses 471.0 547.0 +76.0 +16.1% 737.0 +26.1
Slide 6: XTANDI & XOSPATA: Business Update
XTANDI & XOSPATA: BUSINESS UPDATE 6 Performance in line with the full-year forecast upwardly revised in Q2, expect to achieve the full-year forecast (billion yen) Q3/FY2023 YTD YoY FY2023 FCST Global sales are in line with the full-year forecast revised upward in Q2 ~5% growth even excluding FX
Slide 7: PADCEV: Business Update
PADCEV: BUSINESS UPDATE 7 Peak sales revised upward to 400 - 500 billion yen incorporating the robust results of EV-302 study (billion yen) Q3/FY2023 YTD YoY FY2023 FCST Update of potential peak sales +22.5 55.6 （+68%） 85.2 Updated sales forecast incorporating the robust results of EV-302 study wh
Slide 8: VEOZAH: Business Update
VEOZAH: BUSINESS UPDATE 8 Overall initiatives are progressing, however, demand trails internal expectations Downward revision of full-year forecast, reassessed the timing and pace of the FY2023 demand ramp to delay Q3/FY2023 YTD FY2023 Revised FCST Factors for the downward revision DTC activities
Slide 9: IZERVAY: Business Update
IZERVAY: BUSINESS UPDATE 9 Encouraging first full quarter performance since launch in the US, expect significant growth in FY2024 (billion yen) Q3/FY2023 YTD FY2023 FCST DTC activities to increase awareness (as of Dec 2023) Branded campaign for IZERVAY: 5.3 11.0 • Achieved 55% brand awareness amon
Slide 10: Q3/FY2023 Financial Results: Cost Items
Q3/FY2023 FINANCIAL RESULTS: COST ITEMS 10 SG&A expenses increased YoY due to the impact of the acquisition of Iveric Bio and the investment in VEOZAH, however, progress in line with expectations Core basis: YoY comparison, ratio to revenue, and progress against FCST, for major cost items Ratio to P
Slide 11: FY2023 Revised Forecast
FY2023 REVISED FORECAST 11 Revenue: Downward revision VEOZAH: Full-year forecast revised downward incorporating current progress No change has been made on exchange rates and other products’ full-year forecast Core OP: Downward revision Profit also revised downward aligned with VEOZAH’s do
Slide 12: Agenda
AGENDA 12 Q3/FY2023 Consolidated Financial Results I FY2023 Revised Forecasts II Initiatives for Sustainable Growth
Slide 13: Initiatives for Sustainable Growth: Overview
INITIATIVES FOR SUSTAINABLE GROWTH: OVERVIEW 13 XTANDI and Strategic products enzalutamide / XTANDI : Approval of additional indication for M0 CSPC* (US) enfortumab vedotin / PADCEV : Approval (US) and filing (Europe, Japan) of additional indication for 1L mUC zolbetuximab : Complete response
Slide 14: XTANDI and Strategic Products: Key Events Expected in FY2023
XTANDI AND STRATEGIC PRODUCTS: KEY EVENTS EXPECTED IN FY2023 14 Q1 (Apr-Jun) Q2 (Jul-Sep) Q3 (Oct-Dec) Q4 (Jan-Mar) Acceptance Approval enzalutamide/ (M0 CSPC*; US) (M0 CSPC*; US) Aug Nov XTANDI Acceptance Sep (M0 CSPC*; Europe, M1 CSPC; China) enfortumab Acceptance Approval EV-302 TLR vedotin/ (1L
Slide 15: Progress in Late-Stage Pipeline
PROGRESS IN LATE-STAGE PIPELINE 15 4 regulatory approvals for new indication or region received during the quarter Indication Region First novel hormonal therapy for the indication M0 CSPC with BCR at high risk US Approved for monotherapy as well as combination for metastasis with GnRH analog
Slide 16: Zolbetuximab: Latest Status
ZOLBETUXIMAB: LATEST STATUS 16 <Complete response letter (CRL) by FDA> Unresolved deficiencies following pre-license inspection of a third-party manufacturing facility FDA has not raised any concerns related to the clinical data, and is not requesting additional clinical studies <Action plan> A
Slide 17: Progress in Focus Area Approach: Projects in Clinical Trial
PROGRESS IN FOCUS AREA APPROACH: 17 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 ongo
Slide 18: Open Innovation Initiatives
OPEN INNOVATION INITIATIVES 18 Advancing open innovation in life science ecosystems globally and accelerating early R&D Activities at research stage Activities at early development stage Focused on incorporating external innovation and co- creation through collaborations with academia and other co
Slide 19: Progress in FY2023 and Future Outlook
PROGRESS IN FY2023 AND FUTURE OUTLOOK 19 Achieved many key milestones including new product launches and additional indications in FY2023 Expecting Revenue and Profit to increase in FY2024 through contribution of VEOZAH, PADCEV and IZERVAY as growth drivers Major progress in FY2023 contributing
Slide 20: Appendix
APPENDIX
Slide 21: Q3/FY2023: Revenue by Region
Q3/FY2023: REVENUE BY REGION 21 (billion yen) Q3/FY2022 Q3/FY2023 Change (%) Japan 204.5 211.0 +3.2% United States 501.1 481.4 -3.9% Established Markets 272.2 306.3 +12.5% Greater China 65.2 67.3 +3.3% International Markets 104.2 118.8 +14.0% Established Markets: Europe, Canada, etc., Greater China:
Slide 22: Q3/FY2023 Actual: FX Rate
Q3/FY2023 ACTUAL: FX RATE 22 Average rate for the period Currency Q3/FY2022 Q3/FY2023 Change USD 137 yen 143 yen +7 yen EUR 141 yen 155 yen +15 yen <Impact of exchange rate on financial results> 58.8 billion yen increase in revenue, 13.8 billion yen increase in core OP
Slide 23: FY2023 Forecast: FX Rate & FX Sensitivity
FY2023 FORECAST: FX RATE & FX SENSITIVITY 23 Exchange rate FY2023 FY2023 Change Average for the period Initial FCST Revised FCST* USD 130 yen 140 yen +10 yen EUR 140 yen 152 yen +12 yen Forecast rates Q3/FY2023 onwards: 140 yen/USD, 150 yen/EUR Estimated FX sensitivity (Q3 onwards) of FY2023 revised
Slide 24: Balance Sheet & Cash Flow Highlights
BALANCE SHEET & CASH FLOW HIGHLIGHTS 24 (billion yen) FY2022 end Dec 31, 2023 Total assets 2,456.5 3,368.7 Cash and cash equivalents 376.8 254.0 Total equity attributable to owners of the parent 1,508.0 1,503.3 Equity ratio (%) 61.4% 44.6% (billion yen) Q3/FY2022 Q3/FY2023 Cash flows from operating
Slide 25: Main Intangible Assets (as of Dec 31, 2023)
MAIN INTANGIBLE ASSETS (AS OF DEC 31, 2023) 25 Bil. yen Foreign currency* AT132 15.3 USD 109M AT845 10.2 USD 73M Other gene therapy related program** 92.5 USD 656M Gene therapy related technology** 68.1 USD 483M VEOZAH 90.0 EUR 566M EVRENZO 21.4 - zolbetuximab 64.0 EUR 493M IZERVAY （US） 702.6 USD 4,
Slide 26: Capital Allocation
CAPITAL ALLOCATION 26 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 27: Robust Pipeline of Astellas
ROBUST PIPELINE OF ASTELLAS 27 Phase 1 Phase 2 Phase 3 Submitted/Filed enfortumab vedotin enfortumab vedotin enfortumab vedotin enzalutamide (NMIBC) (Other solid tumors) (MIBC) (M0 CSPC*: Europe, M1 CSPC: China) gilteritinib zolbetuximab gilteritinib enfortumab vedotin (Newly diagnosed AML, HIC-inel
Slide 28: Progress in Overall Pipeline
PROGRESS IN OVERALL PIPELINE 28 Phase 1 Entry to Approval since the Last Financial Results Announcement Phase 1 Entry Phase 2 Entry Phase 3 Entry Filing Approval fezolinetant enfortumab vedotin enzalutamide Vasomotor symptoms Locally advanced or Nonmetastatic castration- associated with metastatic u
Slide 29: XTANDI and Strategic Products: Status Update
XTANDI AND STRATEGIC PRODUCTS: STATUS UPDATE 29 (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 US in Nov 2023. Type II
Slide 30: Enzalutamide (1/2): Androgen Receptor Inhibitor
ENZALUTAMIDE (1/2): ANDROGEN RECEPTOR INHIBITOR 30 (Red: 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 r
Slide 31: Enzalutamide (2/2): Phase 3 Study Data by Disease Stage
ENZALUTAMIDE (2/2): PHASE 3 STUDY DATA BY DISEASE STAGE 31 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 32: Enfortumab Vedotin (1/4): Nectin-4 Targeted ADC Overall UC Program
ENFORTUMAB VEDOTIN (EV) (1/4): NECTIN-4 TARGETED ADC 32 OVERALL UC PROGRAM (Red: 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 inhibit
Slide 33: Enfortumab Vedotin (2/4): Clinical Studies
ENFORTUMAB VEDOTIN (EV) (2/4): CLINICAL STUDIES 33 (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 34: Enfortumab Vedotin (3/4): Study Data by Disease Stage of UC
ENFORTUMAB VEDOTIN (EV) (3/4): 34 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 35: Enfortumab Vedotin (4/4): Future Outlook
ENFORTUMAB VEDOTIN (EV) (4/4): FUTURE OUTLOOK 35 (Red: Updates since the last financial results announcement) 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
Slide 36: Gilteritinib: FLT3 Inhibitor
GILTERITINIB: FLT3 INHIBITOR 36 (Red: 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 VICERO
Slide 37: Zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody
ZOLBETUXIMAB: ANTI-CLAUDIN 18.2 MONOCLONAL ANTIBODY 37 (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 38: Fezolinetant: NK3 Receptor Antagonist
FEZOLINETANT: NK3 RECEPTOR ANTAGONIST 38 (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 39: Avacincaptad Pegol (ACP): Complement C5 Inhibitor
AVACINCAPTAD PEGOL (ACP): 39 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 40: Focus Area Approach: Key Events Expected in FY2023
FOCUS AREA APPROACH: KEY EVENTS EXPECTED IN FY2023 40 Expecting Phase 1 entry in 4 projects and several progress in Phase 1 studies toward PoC judgment Phase 1 Primary Focus IND Early data readout* Dosing resumption Genetic Regulation 1 project AT845 2 projects ASP1570 Immuno-Oncology ( ASP1012)
Slide 41: On the Forefront of Healthcare Change
ON THE FOREFRONT OF HEALTHCARE CHANGE