Astellas Pharma Inc. · TSE:4503
Astellas Pharma — FY2022 Earnings Presentation
48 slides from Astellas Pharma's earnings presentation, Apr 27, 2023
Slide 1: FY2022 Financial Results Ended March 31, 2023
FY2022 FINANCIAL RESULTS ENDED MARCH 31, 2023 Naoki Okamura President and CEO Astellas Pharma Inc. April 27, 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: Toward Achievement of CSP2021
TOWARD ACHIEVEMENT OF CSP2021 3 ⚫ Continue commitment to CSP2021 ⚫ FY2023 is the turning point to ensure growth from FY2024 onwards FY2022 Review FY2023 Prospects • Core results in line with expectations, Sustainable but slightly behind full-year forecast fezolinetant growth after LOE of • fezolinet
Slide 4: Agenda
AGENDA 4 I FY2022 Consolidated Financial Results II Initiatives for Sustainable Growth FY2023 Forecasts and III Key Expected Events
Slide 5: FY2022 Financial Results: Overview
FY2022 FINANCIAL RESULTS: OVERVIEW 5 Revenue increased 17% YoY and was in line with expectations, but slightly behind full-year forecast XTANDI, PADCEV and XOSPATA expanded as expected with full-year forecasts Cost items ⚫ Cost of sales ratio was as expected ⚫ SG&A expenses were on track and decreas
Slide 6: FY2022 Financial Results
FY2022 FINANCIAL RESULTS 6 Change FY2022 (billion yen) FY2021 FY2022 Change Achievement FX impact (YoY) (%) FCST 1 Revenue 1,296.2 1,518.6 +222.5 +17.2% 1,529.0 99.3% +164.4 bil. yen Cost of sales 253.0 288.4 +35.3 +14.0% +16.5 bil. yen (Incl. the impact of elimination of unrealized profit % of reve
Slide 7: FY2022 Financial Results: Main Products
FY2022 FINANCIAL RESULTS: MAIN PRODUCTS 7 XTANDI, PADCEV, XOSPATA showed solid growth in line with full-year forecast Achievement (billion yen) FY2022 Act YoY FY2022 FCST* against FCST ✓ Global sales showed growth in line with FCST US: Total demand growth offset by affordability challenges including
Slide 8: FY2022 Financial Results: Cost Items
FY2022 FINANCIAL RESULTS: COST ITEMS 8 Cost of sales ratio was as expected SG&A expenses were on track and decreased YoY when excluding FX impact R&D expenses were on track Core basis: YoY comparison, ratio to revenue, and achievement against FCST, for major cost items Cost Items YoY change Ratio to
Slide 9: Agenda
AGENDA 9 I FY2022 Consolidated Financial Results II Initiatives for Sustainable Growth FY2023 Forecasts and III Key Expected Events
Slide 10: XTANDI & Strategic Products: Key Events in FY2022
XTANDI & STRATEGIC PRODUCTS: KEY EVENTS IN FY2022 10 Q1 (Apr-Jun) Q2 (Jul-Sep) Q3 (Oct-Dec) Q4 (Jan-Mar) enzalutamide/ EMBARK TLR XTANDI China ARCHES TLR EV-103 Cohort K TLR Mar (1L mUC, Cis-ineligible) Filing (US) Approval (US) enfortumab Jul Dec Apr vedotin/ EV-203 TLR (pre-treated mUC; China) Fil
Slide 11: Enzalutamide/XTANDI: Latest Status
ENZALUTAMIDE/XTANDI: LATEST STATUS 11 ⚫ Aiming for regulatory submission in US as well as Europe, based on the positive topline results from EMBARK study ⚫ Revised potential peak sales upward to 700 billion yen EMBARK study ⚫ Study design ⚫ Topline results Suspend ➢ Met primary endpoint of MFS Place
Slide 12: Progress in Focus Area Approach (1/2): Current Status of Projects in Clinical Trial
PROGRESS IN FOCUS AREA APPROACH (1/2): 12 CURRENT STATUS OF PROJECTS IN CLINICAL TRIAL (Red: Updates since the last financial results announcement) No. of projects Primary Focus Biology/Modality/Technology 1 Project Current status aiming PoC by end FY25 2 AT132 ASPIRO study put on clinical hold by F
Slide 13: Progress in Focus Area Approach (2/2): AT845 Preliminary Data from FORTIS Study
PROGRESS IN FOCUS AREA APPROACH (2/2): 13 AT845 PRELIMINARY DATA FROM FORTIS STUDY ⚫ Three of four participants have discontinued enzyme replacement therapy (ERT)* following administration of AT845 1 ⚫ Their measured functional outcomes have been stable while off ERT *ERT: only approved treatment fo
Slide 14: Progress in Rx+ Program: Summary of FY2022
PROGRESS IN Rx+ PROGRAM: SUMMARY OF FY2022 14 (Red: Updates since the last financial results announcement) Key events expected in FY2022 (announced in Apr 2022) Category Program Event Progress Digital health Initiation of pilot EG Holter Jun 2022: Initiated sales pilot Other services marketing Jan 2
Slide 15: Agenda
AGENDA 15 I FY2022 Consolidated Financial Results II Initiatives for Sustainable Growth FY2023 Forecasts and III Key Expected Events
Slide 16: FY2023 Forecast: Overview
FY2023 FORECAST: OVERVIEW 16 ⚫ Revenue to be the same level as previous fiscal year Sales contributions of fezolinetant and PADCEV offsetting decrease in sales of Lexiscan ✓ SG&A expenses to increase YoY mainly due to investment in fezolinetant and zolbetuximab ✓ Implementation of continued pursuit
Slide 17: FY2023 Forecast
FY2023 FORECAST 17 FY2023 FCST (FX rate) FY2022 FY2023 (billion yen) Change (%) USD: 130 yen actual forecast EUR: 140 yen Revenue 1,518.6 1,520.0 +0.1% FX impact: -40.8 bil. yen SG&A expenses 630.3 661.0 +4.9% US XTANDI co-pro fee 175.5 176.0 +0.3% SG&A excl. the above 454.8 485.0 +6.6% R&D expenses
Slide 18: FY2023 Forecast: Main Products
FY2023 FORECAST: MAIN PRODUCTS 18 Expect continued growth led by PADCEV, with sales contribution from fezolinetant (billion yen) FY2023 FCST YoY Main growth factors ✓ US: Expect continued growth within the current indication; and potential approval +8.8 (+1%) of M0 CSPC additional indication by the
Slide 19: FY2023 Forecast: Cost Items
FY2023 FORECAST: COST ITEMS 19 Allocate limited resources in a disciplined manner to drive sustainable growth from FY2024 onwards FY2024 and beyond Main factors for increase/decrease (YoY) Accelerating future growth, Optimize cost structure SG&A expenses (excl. US XTANDI co-pro fee) ・ Investments in
Slide 20: XTANDI & Strategic Products: Key Events Expected in FY2023
XTANDI & STRATEGIC PRODUCTS: KEY EVENTS EXPECTED IN FY2023 20 Q1 (Apr-Jun) Q2 (Jul-Sep) Q3 (Oct-Dec) Q4 (Jan-Mar) Filing Filing enzalutamide/ (M0 CSPC; US) (M0 CSPC; Europe) XTANDI Filing (M1 CSPC; China) enfortumab vedotin/ EV-302 TLR 1 Filing (1L mUC; global) PADCEV zolbetuximab Filing Filing (US,
Slide 21: Focus Area Approach: Key Events Expected in FY2023
FOCUS AREA APPROACH: KEY EVENTS EXPECTED IN FY2023 21 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 1 Dosing resumption Genetic Regulation 1 project AT845 ASP1570 Immuno-Oncology 2 projects ASP2138 Blind
Slide 22: New R&D Operating Model
NEW R&D OPERATING MODEL 22 To achieve meaningful PoC as early as possible, enable agile decision making by empowering projects and Primary Focuses throughout the project lifecycle Kachi ➢ Cross-Primary Focus (PF) / cross-project prioritization Committee ➢ Decision making focusing on key development
Slide 23: Toward Achievement of CSP2021
TOWARD ACHIEVEMENT OF CSP2021 23 ⚫ Continue commitment to CSP2021 ⚫ FY2023 is the turning point to ensure growth from FY2024 onwards Sustainable fezolinetant growth after LOE of XTANDI PADCEV CSP2021 target zolbetuximab approx. 30% 25% Post-PoC PF 19% portfolio Optimization of cost structure Revenue
Slide 24: Upcoming Event: fezolinetant Meeting
UPCOMING EVENT 24 fezolinetant Meeting ➢ To be held after approval (Details will be delivered later)
Slide 25: Appendix
APPENDIX
Slide 26: Change Exchange Rates Used for Elimination of Unrealized Profit on Inventories
CHANGE EXCHANGE RATES USED FOR ELIMINATION OF UNREALIZED 26 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 Year to Date (billion yen) Change Q1/FY21
Slide 27: FY2022: Revenue by Region
FY2022: REVENUE BY REGION 27 (billion yen) FY2021 FY2022 Change (%) Japan 258.8 262.3 +1.4% United States 537.5 652.4 +21.4% Established Markets 306.5 358.4 +16.9% Greater China 66.3 80.0 +20.7% International Markets 118.7 144.7 +21.9% Established Markets: Europe, Canada Greater China: China, Hong K
Slide 28: FY2022: Sales of Main Products
FY2022: SALES OF MAIN PRODUCTS 28 FY2022 (billion yen) FY2021 FY2022 Change CER growth FCST* XTANDI 534.3 661.1 +23.7% +8.5% 670.0 PADCEV 21.7 44.4 +104.4% +79.2% 45.4 XOSPATA 34.1 46.6 +36.7% +19.3% 45.8 EVRENZO 2.6 3.2 +23.0% +20.8% 5.0 mirabegron 172.3 188.6 +9.5% -3.4% 195.0 Prograf 185.4 198.8
Slide 29: FY2022 Actual: FX Rate
FY2022 ACTUAL: FX RATE 29 Average rate for the period Currency FY2021 FY2022 Change USD 112 yen 135 yen -23 yen EUR 131 yen 141 yen -10 yen Change in current rate from previous fiscal year end Currency FY2021 FY2022 USD -11 yen -11 yen EUR -5 yen -9 yen <Impact of exchange rate on financial results>
Slide 30: FY2023 Forecast: FX Rate & FX Sensitivity
FY2023 FORECAST: FX RATE & FX SENSITIVITY 30 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 31: FY2023 Forecast: XTANDI (Region)
FY2023 FORECAST: XTANDI (REGION) 31 (billion yen) FY2023 FCST YoY Main growth factors +8.8 (+1%) ✓ Expect continued growth globally in actual business excluding FX impact 669.9 Excl. FX impact* ✓ Expect sales growth in all regions +30.7 (+5%) ✓ Despite the challenging conditions of PAP and generic c
Slide 32: FY2023 Forecast: PADCEV (Region)
FY2023 FORECAST: PADCEV (REGION) 32 (billion yen) FY2023 FCST YoY Main growth factors +22.3 (+50%) ✓ Expect strong growth, driven by the contribution of 1L mUC indication in the US 66.7 Excl. FX impact* ✓ Sales growth in all regions +23.5 (+54%) ✓ Obtained approval for 1L mUC additional indication i
Slide 33: Balance Sheet & Cash Flow Highlights
BALANCE SHEET & CASH FLOW HIGHLIGHTS 33 (billion yen) FY2021 end FY2022 end Total assets 2,332.4 2,456.5 Cash and cash equivalents 316.0 376.8 Total equity attributable to owners of the parent 1,460.3 1,508.0 Equity ratio (%) 62.6% 61.4% (billion yen) FY2021 FY2022 Cash flows from operating activiti
Slide 34: Capital Allocation
CAPITAL ALLOCATION 34 1 Top priority is investment 2 Raise dividend level aligned 3 Flexibly execute share Acquisition of own shares announced in Feb. 2023 for business growth with profit / cashflow plan and buyback by excess cash ◼ From Feb 7 to Mar 15, 2023 actual performance ◼ 26.18 million share
Slide 35: Robust Pipeline of Astellas
ROBUST PIPELINE OF ASTELLAS 35 Phase 1 Phase 2 Phase 3 Submitted/Filed enfortumab vedotin enfortumab vedotin enzalutamide enfortumab vedotin (NMIBC) (Other solid tumors) (M0 CSPC, M1 CSPC: China) (mUC pretreated: China) gilteritinib zolbetuximab enfortumab vedotin fezolinetant (Newly diagnosed AML,
Slide 36: Progress in Overall Pipeline
PROGRESS IN OVERALL PIPELINE 36 Phase 1 Entry to Approval since the Last Financial Results Announcement Phase 1 Entry Phase 2 Entry Phase 3 Entry Filing Approval enfortumab enfortumab vedotin vedotin Locally advanced or Locally advanced or metastatic urothelial metastatic urothelial cancer who recei
Slide 37: XTANDI & Strategic Products: Status Update
XTANDI & STRATEGIC PRODUCTS: STATUS UPDATE 37 (Red: Updates since the last financial results announcement) Project / Product Indication Current status enzalutamide / M1 CSPC • Europe: Label update to include the OS data approved in Mar 2023 XTANDI • China: Obtained topline results from Phase 3 China
Slide 38: Enzalutamide (1/2): Androgen Receptor Inhibitor
ENZALUTAMIDE (1/2): ANDROGEN RECEPTOR INHIBITOR 38 (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 39: Enzalutamide (2/2): Phase 3 Study Data by Disease Stage
ENZALUTAMIDE (2/2): PHASE 3 STUDY DATA BY DISEASE STAGE 39 (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 40: Enfortumab Vedotin (1/4): Nectin-4 Targeted ADC Overall UC Program
ENFORTUMAB VEDOTIN (EV) (1/4): NECTIN-4 TARGETED ADC 40 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 41: Enfortumab Vedotin (2/4): Clinical Studies
ENFORTUMAB VEDOTIN (EV) (2/4): CLINICAL STUDIES 41 (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 42: Enfortumab Vedotin (3/4): Study Data by Disease Stage of UC
ENFORTUMAB VEDOTIN (EV) (3/4): 42 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 Platinum naïve Cis-ineligible Platinum pretreated eligible ineligible eligible & Cis-in
Slide 43: Enfortumab Vedotin (4/4): Future Outlook
ENFORTUMAB VEDOTIN (EV) (4/4): FUTURE OUTLOOK 43 (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 44: Gilteritinib: FLT3 Inhibitor
GILTERITINIB: FLT3 INHIBITOR 44 (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 45: Zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody
ZOLBETUXIMAB: ANTI-CLAUDIN 18.2 MONOCLONAL ANTIBODY 45 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 46: Fezolinetant: NK3 Receptor Antagonist
FEZOLINETANT: NK3 RECEPTOR ANTAGONIST 46 (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 47: AT132 (Resamirigene Bilparvovec): rAAV8-Des-hMTM1
AT132 (RESAMIRIGENE BILPARVOVEC): rAAV8-Des-hMTM1 47 Characteristics of AT132 X-linked myotubular myopathy (XLMTM) ⚫ Delivers a functional copy of human MTM1 gene by AAV8 to ⚫ Rare neuromuscular disease with X-linked, transfect and express myotubularin in skeletal muscle cells loss of function mutat
Slide 48: On the Forefront of Healthcare Change
ON THE FOREFRONT OF HEALTHCARE CHANGE