Astellas Pharma Inc. · TSE:4503
Astellas Pharma — Q1 2023 Earnings Presentation
42 slides from Astellas Pharma's earnings presentation, Aug 1, 2023
Slide 1: Q1/FY2023 Financial Results Ended June 30, 2023
Q1/FY2023 FINANCIAL RESULTS ENDED JUNE 30, 2023 Naoki Okamura President and CEO Astellas Pharma Inc. August 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 I Q1/FY2023 Consolidated Financial Results II Initiatives for Sustainable Growth
Slide 4: Q1/FY2023 Financial Results: Overview
Q1/FY2023 FINANCIAL RESULTS: OVERVIEW 4 Revenue ⚫ Revenue decreased 2% YoY, due to the impact of Lexiscan generic ⚫ XTANDI and XOSPATA expanded as expected, while PADCEV exceeded expectations ⚫ VEOZAH’s initial uptake in line with expectations Cost items ⚫ SG&A and R&D expenses were on track Operati
Slide 5: Q1/FY2023 Financial Results
Q1/FY2023 FINANCIAL RESULTS 5 Change FY23 (billion yen) Q1/FY22 Q1/FY23 Change Progress FX impact** (YoY) (%) FCST* Revenue 381.8 375.0 -6.8 -1.8% 1,520.0 24.7% +17.5 bil. yen Cost of sales 88.9 68.9 -19.9 -22.4% -11.1 bil. yen % of revenue 23.3% 18.4% -4.9ppt SG&A expenses 153.4 168.2 +14.8 +9.6% 6
Slide 6: Q1/FY2023 Financial Results: Main Products
Q1/FY2023 FINANCIAL RESULTS: MAIN PRODUCTS 6 XTANDI and XOSPATA are in line, PADCEV exceeded expectations. VEOZAH’s uptake on track (billion yen) Q1/FY2023 Act YoY FY2023 FCST* ✓ Global sales are in line with expectations Ex-US performance are above/in line offsetting the US underperformance ✓ US: P
Slide 7: VEOZAH: Business Update
VEOZAH: BUSINESS UPDATE 7 Launched in May, sales force activities started in June, with inclusion in treatment guideline as recommended drug Overall progress is in line with expectations, substantial sales growth expected from Q3 onward Q1 Progress Outlook for Q3 onward ✓ Commercial insurance covera
Slide 8: Q1/FY2023 Financial Results: Cost Items
Q1/FY2023 FINANCIAL RESULTS: COST ITEMS 8 Cost of sales ratio was as expected SG&A and R&D expenses were on track Core basis: YoY comparison, ratio to revenue, and progress against FCST, for major cost items Ratio to Progress Cost Items YoY change Revenue against FCST Cost of sales -22.4% 18.4% - ✓
Slide 9: FY2023 Revised Forecast
FY2023 REVISED FORECAST 9 ⚫ No changes have been made to Core basis FY2023 forecast ✓ Plan to reassess in Q2, considering the impact of the Iveric Bio acquisition ⚫ Downward revision of Full basis profit ✓ Planned one-time expenses related to organizational restructuring on a global scale, including
Slide 10: Agenda
AGENDA 10 I Q1/FY2023 Consolidated Financial Results II Initiatives for Sustainable Growth
Slide 11: XTANDI and Strategic Products: Key Events Expected in FY2023
XTANDI AND STRATEGIC PRODUCTS: KEY EVENTS EXPECTED IN FY2023 11 Q1 (Apr-Jun) Q2 (Jul-Sep) Q3 (Oct-Dec) Q4 (Jan-Mar) sNDA Submission Filing enzalutamide/ (M0 CSPC; US) (M0 CSPC; Europe) Jun XTANDI Filing (M1 CSPC; China) enfortumab vedotin/ EV-302 TLR* Filing PADCEV (1L mUC; global) Acceptance (Japan
Slide 12: Enzalutamide / XTANDI: Latest Data
ENZALUTAMIDE / XTANDI: LATEST DATA 12 EMBARK study data presented at AUA 2023, demonstrating consistent benefit of enzalutamide even in early-stage prostate cancer 3-yr rate 5-yr rate 100 92.9% 87.3% Metastasis-free survival (%) 80 enzalutamide + leuprolide acetate 83.5% placebo + leuprolide acetate
Slide 13: Enfortumab Vedotin / PADCEV: Latest Data
ENFORTUMAB VEDOTIN / PADCEV: LATEST DATA 13 EV-202 study data presented at ASCO 2023, demonstrating promising efficacy in head and neck cancers Head and neck cancers EV-202 study Cohort 5 ⚫ The sixth most common cancer worldwide 1; ⚫ Study design estimated 932,000 new cases and 467,000 deaths Patien
Slide 14: Acquisition of Iveric Bio
ACQUISITION OF IVERIC BIO 14 President: Pravin U. Dugel, MD Organization ⚫ Principal investigator in 100+ multicenter ⚫ Iveric Bio leads ACP-related activities incl. regulatory, clinical trials manufacturing, commercial and market access ⚫ Chair of SAB for multiple global pharma ⚫ Senior team with s
Slide 15: Progress in Focus Area Approach (1/2): Projects in Clinical Trial
PROGRESS IN FOCUS AREA APPROACH (1/2): 15 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 20
Slide 16: Progress in Focus Area Approach (2/2): Collaborations in Targeted Protein Degradation
PROGRESS IN FOCUS AREA APPROACH (2/2): 16 COLLABORATIONS IN PF TARGETED PROTEIN DEGRADATION PeptiDream’s PDPS FIMECS provides access to technology platform Target Functional RaPPIDSTM • Discover multiple expandability enhancement • Efficient synthesis platform novel protein for protein degraders deg
Slide 17: Toward Achievement of CSP2021
TOWARD ACHIEVEMENT OF CSP2021 17 ⚫ Continue commitment to CSP2021 ⚫ FY2023 is the turning point to ensure growth from FY2024 onwards Q1/FY2023 Progress FY2023 Prospects • VEOZAH launch, initial uptake in Sustainable line with expectations VEOZAH growth after LOE of • XTANDI and XOSPATA as expected,
Slide 18: Appendix
APPENDIX
Slide 19: Change Exchange Rates Used for Elimination of Unrealized Profit on Inventories
CHANGE EXCHANGE RATES USED FOR ELIMINATION OF UNREALIZED 19 PROFIT ON INVENTORIES（PRO FORMA FIGURES） ⚫ Pro forma figures when calculating the cost of sales at exchange rate after the change (average rate) is as shown in red font in the table below Quarterly (billion yen) FY2022 FY2023 Q1 Q2 Q3 Q4 Q1
Slide 20: Q1/FY2023: Revenue by Region
Q1/FY2023: REVENUE BY REGION 20 (billion yen) 1Q/FY2022 1Q/FY2023 Change (%) Japan 66.8 68.3 +2.2% United States 160.9 150.0 -6.8% Established Markets 86.6 96.8 +11.8% Greater China 23.2 22.5 -2.7% International Markets 33.9 34.7 +2.4% Established Markets: Europe, Canada, etc., Greater China: China,
Slide 21: Q1/FY2023 Financial Results: XTANDI (Region)
Q1/FY2023 FINANCIAL RESULTS: XTANDI (REGION) 21 (billion yen) Q1/FY2023 Act YoY FY2023 FCST +11.7 （+7%） Global Sales 174.1 Excl. FX impact 669.9 (YoY +1%) +1.9 (+1%) US (Unit: $) $632M $-15M （-2%） $2,635M (+4%) Established Markets (Unit: €) €365M €+26M （+8%） €1,419M (+1%) Japan 14.4 +0.3 （+2%） 58.2
Slide 22: Q1/FY2023 Financial Results: PADCEV (Region)
Q1/FY2023 FINANCIAL RESULTS: PADCEV (REGION) 22 (billion yen) Q1/FY2023 Act YoY FY2023 FCST +4.7 （+44%） Global Sales 15.2 Excl. FX impact 66.7 (YoY +50%) +3.9 (+37%) US (Unit: $) $76M $+20M （+35%） $341M (+59%) Established Markets (Unit: €) €16M €+7M （+79%） €82M (+70%) Japan 2.2 +0.3 （+13%） 9.9 (+18%
Slide 23: Q1/FY2023 Actual: FX Rate
Q1/FY2023 ACTUAL: FX RATE 23 Average rate for the period Currency Q1/FY2022 Q1/FY2023 Change USD 130 yen 137 yen -8 yen EUR 138 yen 150 yen -11 yen Change in current rate from previous fiscal year end Currency Q1/FY2022 Q/FY2023 USD -14 yen -12 yen EUR -8 yen -14 yen <Impact of exchange rate on fina
Slide 24: FY2023 Forecast: FX Rate & FX Sensitivity
FY2023 FORECAST: FX RATE & FX SENSITIVITY 24 Exchange rate FY2022 FY2023 FCST Change Average for the period USD 135 yen 130 yen +5 yen EUR 141 yen 140 yen +1 yen Estimated FX sensitivity of FY2023 forecasts by 1 yen appreciation Average rate Currency 1 yen higher than assumption Revenue Core OP USD
Slide 25: Balance Sheet & Cash Flow Highlights
BALANCE SHEET & CASH FLOW HIGHLIGHTS 25 (billion yen) FY2022 end Jun 30, 2023 Total assets 2,456.5 2,798.0 Cash and cash equivalents 376.8 561.5 Total equity attributable to owners of the parent 1,508.0 1,578.4 Equity ratio (%) 61.4% 56.4% (billion yen) Q1/FY2022 Q1/FY2023 Cash flows from operating
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 enzalutamide enzalutamide (NMIBC) (Other solid tumors) (M0 CSPC: Europe, M1 CSPC: China) (M0 CSPC: US) gilteritinib zolbetuximab enfortumab vedotin enfortumab vedotin (Newly diagnosed AML, HI
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 enzalutamide fezolinetant Non-metastatic Vasomotor symptoms castration-sensitive associated with prostate cancer: US menopause: US zolbetu
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 • China: Obtained topline results from Phase 3 China ARCHES study in Mar 2023 XTANDI M0 CSPC • sNDA submitted in US in Jun 2
Slide 30: XTANDI and Strategic Products: Potential Peak Sales
XTANDI AND STRATEGIC PRODUCTS: POTENTIAL PEAK SALES 30 (AS OF JULY 2023) Potential Peak Sales Product (Global, billions of yen) XTANDI (enzalutamide) over 700 VEOZAH (fezolinetant) 300 - 500 PADCEV (enfortumab vedotin) 1 300 - 400 XOSPATA (gilteritinib) 100 - 200 zolbetuximab 100 - 200 EVRENZO (roxa
Slide 31: Enzalutamide (1/2): Androgen Receptor Inhibitor
ENZALUTAMIDE (1/2): ANDROGEN RECEPTOR INHIBITOR 31 (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 32: Enzalutamide (2/2): Phase 3 Study Data by Disease Stage
ENZALUTAMIDE (2/2): PHASE 3 STUDY DATA BY DISEASE STAGE 32 (Red: Updates since the last financial results announcement) Continued potential in earlier lines with consistent survival benefit and longer duration of treatment Early stage Late stage Castration-sensitive (CSPC) Castration-resistant (CRPC
Slide 33: Enfortumab Vedotin (1/4): Nectin-4 Targeted ADC Overall UC Program
ENFORTUMAB VEDOTIN (EV) (1/4): NECTIN-4 TARGETED ADC 33 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 34: Enfortumab Vedotin (2/4): Clinical Studies
ENFORTUMAB VEDOTIN (EV) (2/4): CLINICAL STUDIES 34 (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 35: Enfortumab Vedotin (3/4): Study Data by Disease Stage of UC
ENFORTUMAB VEDOTIN (EV) (3/4): 35 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 Platinum naïve Cis-ineligi
Slide 36: Enfortumab Vedotin (4/4): Future Outlook
ENFORTUMAB VEDOTIN (EV) (4/4): FUTURE OUTLOOK 36 (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 37: Gilteritinib: FLT3 Inhibitor
GILTERITINIB: FLT3 INHIBITOR 37 (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 38: Zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody
ZOLBETUXIMAB: ANTI-CLAUDIN 18.2 MONOCLONAL ANTIBODY 38 (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 39: Fezolinetant: NK3 Receptor Antagonist
FEZOLINETANT: NK3 RECEPTOR ANTAGONIST 39 (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 40: Avacincaptad Pegol (ACP): Complement C5 Inhibitor / Pegylated RNA Aptamer
AVACINCAPTAD PEGOL (ACP): 40 COMPLEMENT C5 INHIBITOR / PEGYLATED RNA APTAMER Geographic atrophy (GA) Characteristics of ACP ⚫ Advanced form of dry age-related macular degeneration ⚫ ACP inhibits complement C5, and slows inflammation (AMD) and cell death associated with development and ⚫ ~1.6 million
Slide 41: Focus Area Approach: Key Events Expected in FY2023
FOCUS AREA APPROACH: KEY EVENTS EXPECTED IN FY2023 41 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 ASP1570 Immuno-Oncology 2 projects ASP2138 Blindn
Slide 42: On the Forefront of Healthcare Change
ON THE FOREFRONT OF HEALTHCARE CHANGE