Slide 1: Q2/FY2023 Financial Results
Q2/FY2023 FINANCIAL RESULTS ENDED SEPTEMBER 30, 2023 Naoki Okamura President and CEO Astellas Pharma Inc. November 1, 2023
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/FY2023 Consolidated Financial Results I FY2023 Revised Forecasts II Initiatives for Sustainable Growth
Slide 4: Q2/FY2023 Financial Results: Overview
Q2/FY2023 FINANCIAL RESULTS: OVERVIEW 4 Disclosing the consolidated financial results reflecting the impact of the acquisition of Iveric Bio starting from Q2/FY2023 Revenue increased YoY (when excl. the FX impact, revenue decreased due to the impact of LEXISCAN generic) ⚫ Oncology products (XTANDI,
Slide 5: Accounting Treatment of Business Combination with Iveric Bio
ACCOUNTING TREATMENT OF 5 BUSINESS COMBINATION WITH IVERIC BIO Booked intangible assets of $6,300M and goodwill of $251M <Opening balance sheet as of July 11, 2023*> ($ million) Other assets Other liabilities 408 164 • IZERVAY US Deferred tax liabilities $5,200M 1,062 →Amortisation started from Q2/F
Slide 6: Q2/FY2023 Financial Results
Q2/FY2023 FINANCIAL RESULTS 6 Change FY23 (billion yen) Q2/FY22 Q2/FY23 Change Progress FX impact (YoY) (%) Initial FCST* Revenue 762.2 767.1 +5.0 +0.6% 1,520.0 50.5% +37.8 bil. yen Cost of sales 151.7 143.4 -8.3 -5.5% +6.5 bil. yen % of revenue 19.9% 18.7% -1.2 ppt SG&A expenses 308.0 347.5 +39.5 +
Slide 7: XTANDI, PADCEV, XOSPATA: Business Update
XTANDI, PADCEV, XOSPATA: BUSINESS UPDATE 7 Oncology products exceeding expectations. Upward revision of FCST for each product, total of approx. +18.0 bil yen (excl. FX impact) FY2023 FY2023 (billion yen) Q2/FY2023 Act YoY Initial FCST Revised FCST ✓ Global sales are in line with expectations Ex-US p
Slide 8: VEOZAH: Business Update
VEOZAH: BUSINESS UPDATE 8 Overall activities are on track, however, Q2 sales underperformed due to overestimation of demand prior to DTC launch Fully branded DTC activities including TV commercial started as planned, impact will be assessed going forward (billion yen) Q2/FY2023 Act FY2023 FCST ✓ Q2
Slide 9: IZERVAY: Business Update
IZERVAY: BUSINESS UPDATE 9 Launched in September, initial uptake is on track. Expect breakeven in FY2025 and peak sales of 200.0 - 400.0 bil. yen (billion yen) Q2/FY2023 Act FY2023 FCST <Sales forecast (image)> Potential Peak Sales IZERVAY 200.0 - 400.0 billion yen 1.2 11.0 Sales Costs Amortisation
Slide 10: Q2/FY2023 Financial Results: Cost Items
Q2/FY2023 FINANCIAL RESULTS: COST ITEMS 10 Cost of sales ratio was as expected SG&A expenses were on track and R&D expenses were above full-year forecast (when excl. FX impact and the acquisition of Iveric Bio) Core basis: YoY comparison, ratio to revenue, and progress against FCST, for major cost i
Slide 11: FY2023 Revised Forecast
FY2023 REVISED FORECAST 11 ⚫ Revenue: Upward revision ✓ Reflect positive FX impact. Upward revision in XTANDI, PADCEV, XOSPATA, Downward revision in LEXISCAN ⚫ Core OP: Downward revision Exchange rates for revised forecast: 140 yen/USD, 152 yen/EUR ✓ Downward revision due to the impact of LEXISCAN a
Slide 12: Agenda
AGENDA 12 Q2/FY2023 Consolidated Financial Results I FY2023 Revised Forecasts II Initiatives for Sustainable Growth
Slide 13: Initiatives for Sustainable Growth: Overview of Updates
INITIATIVES FOR SUSTAINABLE GROWTH: OVERVIEW OF UPDATES 13 XTANDI and Strategic products ⚫ enzalutamide / XTANDI : Acceptance of regulatory filing for M0 CSPC* in US and Europe ⚫ enfortumab vedotin / PADCEV : Topline results from EV-302 study, presentation at ESMO ⚫ fezolinetant / VEOZAH : CHMP posi
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 (M0 CSPC*; US) PDUFA target enzalutamide/ Aug XTANDI Acceptance (M0 CSPC*; Europe, M1 CSPC; China) Sep enfortumab vedotin/ EV-302 TLR Filing (US) (1L mUC; global) PADCEV Sep
Slide 15: Enfortumab Vedotin / PADCEV: EV-302 Latest Data
ENFORTUMAB VEDOTIN / PADCEV: EV-302 LATEST DATA 15 ⚫ Statistically significant and clinically meaningful improvement over chemotherapy with nearly doubled mOS and mPFS ⚫ Aiming for position as a new standard of care for 1L mUC <Progression-free survival> <Overall survival> 78.2% 69.5% 50.7% 61.4% 43
Slide 16: Zolbetuximab: Latest Status
ASCO 2023, Chicago ZOLBETUXIMAB: LATEST STATUS 16 Activities related to Claudin 18.2 as a first-in-class target are going well globally as planned toward launch Activities toward launch ESMO 2023, Madrid ESMO GI 2023, Barcelona ⚫ Educational initiatives for HCPs (managing gastric cancer) and patholo
Slide 17: Progress in Focus Area Approach: Current Status of Projects in Clinical Trial
PROGRESS IN FOCUS AREA APPROACH: 17 CURRENT STATUS OF PROJECTS IN CLINICAL TRIAL (Red: Updates since the last financial results announcement) 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 Gen
Slide 18: Toward Achievement of CSP2021
TOWARD ACHIEVEMENT OF CSP2021 18 ⚫ Continue to aim for achievement of original CSP2021, expect breakeven for IZERVAY in FY2025 ⚫ In addition to Strategic products, IZERVAY will also contribute to profits from FY2026 onwards, helping compensate for XTANDI LOE IZERVAY IZERVAY IZERVAY VEOZAH Strategic
Slide 19: Upcoming Events
UPCOMING EVENTS 19 IZERVAY Meeting ✓ Nov 6th 2023 7:30am-8:15am (JST) zolbetuximab Meeting ✓ To be held after anticipated US approval (Dec 2023 - Jan 2024) Sustainability Meeting 2023 ✓ Feb 21st 2024 10:00am-11:30am (JST)
Slide 20: Appendix
APPENDIX
Slide 21: Q2/FY2023: Revenue by Region
Q2/FY2023: REVENUE BY REGION 21 (billion yen) Q2/FY2022 Q2/FY2023 Change (%) Japan 133.3 137.6 +3.2% United States 328.3 306.7 -6.6% Established Markets 175.6 199.1 +13.4% Greater China 45.0 44.9 -0.3% International Markets 67.9 74.6 +10.0% Established Markets: Europe, Canada, etc., Greater China: C
Slide 22: Q2/FY2023 Actual: FX Rate
Q2/FY2023 ACTUAL: FX RATE 22 Average rate for the period Currency Q2/FY2022 Q2/FY2023 Change USD 134 yen 141 yen +7 yen EUR 139 yen 153 yen +15 yen <Impact of exchange rate on financial results> ⚫ 37.8 billion yen increase in revenue, 11.0 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 Sep 30, 2023 Total assets 2,456.5 3,543.0 Cash and cash equivalents 376.8 334.0 Total equity attributable to owners of the parent 1,508.0 1,639.3 Equity ratio (%) 61.4% 46.3% (billion yen) Q2/FY2022 Q2/FY2023 Cash flows from operating
Slide 25: Capital Allocation
CAPITAL ALLOCATION 25 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 26: Robust Pipeline of Astellas
ROBUST PIPELINE OF ASTELLAS 26 Phase 1 Phase 2 Phase 3 Submitted/Filed enfortumab vedotin enfortumab vedotin enfortumab vedotin enzalutamide (NMIBC) (Other solid tumors) (mUC previously untreated, MIBC) (M0 CSPC*: US, Europe, M1 CSPC: China) gilteritinib zolbetuximab gilteritinib (Newly diagnosed AM
Slide 27: Progress in Overall Pipeline
PROGRESS IN OVERALL PIPELINE 27 Phase 1 Entry to Approval since the Last Financial Results Announcement Phase 1 Entry Phase 2 Entry Phase 3 Entry Filing Approval ASP1012 roxadustat enzalutamide avacincaptad pegol Cancer Anemia associated with Non-metastatic hormone- Geographic atrophy chronic kidney
Slide 28: XTANDI and Strategic Products: Status Update
XTANDI AND STRATEGIC PRODUCTS: STATUS UPDATE 28 (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 high-risk BCR • sNDA accepted in US in Aug 2023. Type II variation a
Slide 29: XTANDI and Strategic Products: Potential Peak Sales
XTANDI AND STRATEGIC PRODUCTS: POTENTIAL PEAK SALES 29 (AS OF OCT 2023) Potential Peak Sales Product (Global, billions of yen) XTANDI (enzalutamide) over 700.0 VEOZAH (fezolinetant) 300.0 – 500.0 PADCEV (enfortumab vedotin) 1 300.0 – 400.0 IZERVAY (avacincaptad pegol) 200.0 – 400.0 XOSPATA (gilterit
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/JP Castration-Sensitive Localized Prostate Cancer Castration-Resistant Prostate Cancer Prostate Cancer ARCHES M1 CSPC newly-diagnosed PREVAIL AFFIRM M1 CSPC M1 CRPC M1 CRPC recur
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 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 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 (Red: Updates since the last financial results announcement) 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 Ci
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 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 37: Zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody
ZOLBETUXIMAB: ANTI-CLAUDIN 18.2 MONOCLONAL ANTIBODY 37 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 epithelial sheets HER2-, Claudin 18.2+ locally advanced and ⚫ Broadly
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 / Pegylated RNA Aptamer
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