Astellas Pharma Inc. · TSE:4503
Astellas Pharma — Q3 FY2022 Earnings Presentation
40 slides from Astellas Pharma's earnings presentation, Feb 6, 2023
Slide 1: Q3/FY2022 Financial Results Ended December 31, 2022
Q3/FY2022 FINANCIAL RESULTS ENDED DECEMBER 31, 2022 Minoru Kikuoka Chief Financial Officer (CFO) Astellas Pharma Inc. February 6, 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 Q3/FY2022 Consolidated Financial Results II Initiatives for Sustainable Growth
Slide 4: Q3/FY2022 Financial Results: Overview
Q3/FY2022 FINANCIAL RESULTS: OVERVIEW 4 Revenue increased 17% YoY and was in line with full-year forecast revised in Q2 ⚫ Sales of XTANDI and Strategic products were on track globally ➢ XTANDI: Sales in the US were in line with revised full-year forecast ➢ Strategic products: Sales of PADCEV were in
Slide 5: Q3/FY2022 Financial Results
Q3/FY2022 FINANCIAL RESULTS 5 Change FY22 (billion yen) Q3/FY21 Q3/FY22 Change Progress FX impact (%) FCST* Revenue 992.3 1,164.4 +172.1 +17.3% 1,529.0 76.2% +135.2 bil. yen +13.3 bil. yen (Incl. the impact of Cost of sales 194.1 226.1 +32.0 +16.5% elimination of unrealized profit % of revenue 19.6%
Slide 6: Q3/FY2022 Financial Results & Outlook: XTANDI
Q3/FY2022 FINANCIAL RESULTS & OUTLOOK: XTANDI 6 In line with full-year forecast revised in Q2, expect to achieve the full-year forecast of 670 billion yen (billion yen) Q3/FY2022 Act YoY FY2022 FCST* Progress ✓ Global sales are in line with the full-year forecast revised in Q2 +100.3 (+24%) 670.0 ✓
Slide 7: Q3/FY2022 Financial Results & Outlook: Strategic Products
Q3/FY2022 FINANCIAL RESULTS & OUTLOOK: STRATEGIC PRODUCTS 7 PADCEV and XOSPATA showed solid growth, expect to achieve the full-year forecast (billion yen) Q3/FY2022 Act YoY FY2022 FCST* Progress ✓ Global sales are in line with the full-year forecast revised upward in Q2 +18.5 (+127%) 45.4 ✓ Strong p
Slide 8: Q3/FY2022 Financial Results: Cost Items
Q3/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 progress against FCST, for major cost items Cost Items YoY change Ratio to
Slide 9: Outlook for FY2022
OUTLOOK FOR FY2022 9 ⚫ Core basis: Revenue and Core OP are expected to be in line with full-year forecast Full-year forecast remain unchanged ➢ Revenue: XTANDI and Strategic products are expected to be in line with full-year forecast ⚫ Full basis: Downward revision ➢ “Other expenses” booked in Q3 •
Slide 10: Agenda
AGENDA 10 I Q3/FY2022 Consolidated Financial Results II Initiatives for Sustainable Growth
Slide 11: XTANDI & Strategic Products: Key Events Expected in FY2022
XTANDI & STRATEGIC PRODUCTS: KEY EVENTS EXPECTED IN FY2022 11 Q1 Q2 Q3 Q4 enzalutamide / EMBARK TLR 1 XTANDI China ARCHES TLR 1 EV-103 Cohort K TLR Filing (1L mUC; US) PDUFA target enfortumab Jul Dec Apr vedotin / EV-203 TLR (pre-treated mUC; China) PADCEV Aug EV-202 Initial TLR Jun Jul SPOTLIGHT TL
Slide 12: Zolbetuximab: Latest Status
ZOLBETUXIMAB: LATEST STATUS 12 Achieved primary endpoints in two Phase 3 studies, aiming for global launch Clinical studies <Progression-free survival> ⚫ Topline results obtained in two Phase 3 studies zolbetuximab + mFOLFOX6 HR: 0.751 ➢ SPOTLIGHT: combo with mFOLFOX6 vs. placebo mPFS: 10.61 months
Slide 13: Progress in Focus Area Approach (1/3): Current Status of Projects in Clinical Trial
PROGRESS IN FOCUS AREA APPROACH (1/3): 13 CURRENT STATUS OF PROJECTS IN CLINICAL TRIAL (Red: Updates since the last financial results announcement) Primary Focus Biology/Modality/Technology 1 Project Current status AT132 ASPIRO study put on clinical hold by FDA in Sep 2021 Genetic Gene replacement (
Slide 14: Progress in Focus Area Approach (2/3): Current Status of AT845 and AT132
PROGRESS IN FOCUS AREA APPROACH (2/3): 14 CURRENT STATUS OF AT845 AND AT132 Activities ongoing toward resumption of clinical studies AT845 (Target disease: Pompe disease) AT132 (Target disease: XLMTM) ⚫ Clinical hold lifted by FDA in Jan 2023 ⚫ Initial clinical hold responses submitted in Q3 FY2022
Slide 15: Progress in Focus Area Approach (3/3): Collaboration with Selecta Biosciences
PROGRESS IN FOCUS AREA APPROACH (3/3): 15 COLLABORATION WITH SELECTA BIOSCIENCES Partnering for potential to bring AT845 to more patients Pre-existing immunity (PEI) IdeXork (Xork) ⚫ Patients with PEI have IgG antibodies against AAV and ⚫ Next generation IgG protease candidate which cleaves are not
Slide 16: Progress Toward Achieving CSP2021
PROGRESS TOWARD ACHIEVING CSP2021 16 Revenue, Pipeline Value Core OP XTANDI and Strategic products: 1 5 Flat SG&A in absolute terms ✓ SG&A expenses controlled in line ¥1.2T in FY2025 with full-year forecast, decreased Sufficient R&D investments ✓ Sales in line with revised full-year forecast 6 Cor
Slide 17: Upcoming Event
UPCOMING EVENT 17 Sustainability Meeting ➢ February 17th 2023, 14:00-15:30 (JST) fezolinetant Meeting ➢ March (planned)
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 Year to Date (billion yen) Change Q1/FY21
Slide 20: Q3/FY2022: Revenue by Region
Q3/FY2022: REVENUE BY REGION 20 (billion yen) Q3/FY21 Q3/FY22 Change (%) Japan 203.2 204.5 +0.6% United States 407.9 501.1 +22.8% Established Markets 233.0 271.1 +16.4% Greater China 50.3 65.2 +29.4% International Markets 89.2 105.2 +18.0% Established Markets: Europe, Canada Greater China: China, Ho
Slide 21: Q3/FY2022: Sales of Main Products
Q3/FY2022: SALES OF MAIN PRODUCTS 21 FY22 (billion yen) Q3/FY21 Q3/FY22 Change CER growth FCST* XTANDI 411.6 511.9 +24.4% +7.9% 670.0 PADCEV 14.6 33.1 +126.9% +94.4% 45.4 XOSPATA 25.7 36.3 +41.1% +21.7% 45.8 EVRENZO 2.1 2.4 +15.0% +13.3% 5.0 mirabegron 126.9 141.0 +11.1% -2.8% 195.0 Prograf 141.1 15
Slide 22: Q3/FY2022 Actual: FX Rate
Q3/FY2022 ACTUAL: FX RATE 22 Average rate for the period Currency Q3/FY21 Q3/FY22 Change USD 111 yen 137 yen -25 yen EUR 131 yen 141 yen -10 yen Change in current rate from previous fiscal year end Currency Q3/FY21 Q3/FY22 USD -4 yen -9 yen EUR -1 yen -6 yen <Impact of exchange rate on financial res
Slide 23: FY2022 FCST: FX Rate & FX Sensitivity
FY2022 FCST: FX RATE & FX SENSITIVITY 23 Exchange rate FY2022 FY2022 Average for the period Initial FCST Revised FCST USD 120 yen 137 yen EUR 135 yen 139 yen Forecast rates from Q3 onwards: 140 USD/yen, 140 EUR/yen Estimated FX sensitivity (Q3 onwards) of FY2022 revised forecasts by 1 yen depreciati
Slide 24: Balance Sheet & Cash Flow Highlights
BALANCE SHEET & CASH FLOW HIGHLIGHTS 24 (billion yen) FY21 end FY22 Q3 end Total assets 2,332.4 2,513.9 Cash and cash equivalents 316.0 381.8 Total equity attributable to owners of the parent 1,460.3 1,570.4 Equity ratio (%) 62.6% 62.5% (billion yen) Q3/FY21 Q3/FY22 FY21 Cash flows from operating ac
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 enzalutamide enfortumab vedotin (NMIBC) (Other solid tumors) (M0 CSPC, M1 CSPC: China) (mUC previously untreated, Cis-ineligible: US) gilteritinib zolbetuximab enfortumab vedotin fezolinetant
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 ASP1002 Cancer Note: Phase 1 entry is defined as confirmation of IND open. Phase transition is defined by approval of company decision bod
Slide 28: XTANDI & Strategic Products: Status Update
XTANDI & STRATEGIC PRODUCTS: STATUS UPDATE 28 (Red: Updates since the last financial results announcement) Project / Product Indication Current status enzalutamide / M1 CSPC • EU: CHMP positive opinion received for label update to include the OS data in Mar 2022 XTANDI • China: Phase 3 study ongoing
Slide 29: Enzalutamide (1/2): Androgen Receptor Inhibitor
ENZALUTAMIDE (1/2): ANDROGEN RECEPTOR INHIBITOR 29 US/Europe/JP Definitive Therapy Castration-Sensitive Castration-Resistant ARCHES M1 CSPC Initial newly-diagnosed PREVAIL AFFIRM Diagnosis Surgery M1 CRPC M1 CRPC M1 CSPC recurrent (1st line) (2nd line+) Salvage Launched Launched Launched Active Surv
Slide 30: Enzalutamide (2/2): Phase 3 Study Data by Disease Stage
ENZALUTAMIDE (2/2): PHASE 3 STUDY DATA BY DISEASE STAGE 30 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 31: Enfortumab Vedotin (1/4): Nectin-4 Targeted ADC Overall UC Program
ENFORTUMAB VEDOTIN (EV) (1/4): NECTIN-4 TARGETED ADC 31 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 32: Enfortumab Vedotin (2/4): Clinical Studies
ENFORTUMAB VEDOTIN (EV) (2/4): CLINICAL STUDIES 32 (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 33: Enfortumab Vedotin (3/4): Study Data by Disease Stage of UC
ENFORTUMAB VEDOTIN (EV) (3/4): 33 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 34: Enfortumab Vedotin (4/4): Future Outlook
ENFORTUMAB VEDOTIN (EV) (4/4): FUTURE OUTLOOK 34 ⚫ 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 Peak <Already approved / pivotal ph
Slide 35: Gilteritinib: FLT3 Inhibitor
GILTERITINIB: FLT3 INHIBITOR 35 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 P1 (triplet) Monotherapy vs. salvage Relapsed or refractory P3: ADM
Slide 36: Zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody
ZOLBETUXIMAB: ANTI-CLAUDIN 18.2 MONOCLONAL ANTIBODY 36 (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 37: Fezolinetant: NK3 Receptor Antagonist
FEZOLINETANT: NK3 RECEPTOR ANTAGONIST 37 (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 38: AT132 (Resamirigene Bilparvovec): rAAV8-Des-hMTM1
AT132 (RESAMIRIGENE BILPARVOVEC): rAAV8-Des-hMTM1 38 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 39: Focus Area Approach: Clinical Proof and Expansion of Key Platforms
FOCUS AREA APPROACH: 39 CLINICAL PROOF AND EXPANSION OF KEY PLATFORMS No. of projects Primary Focus Biology/Modality/Technology 1 Lead project FY22 FY23 FY24-25 aiming for PoC Modality by end FY25 2 Small molecule AT132 Antibody Genetic Gene replacement (AAV) Updated timeline for PoC judgement regul
Slide 40: On the Forefront of Healthcare Change
ON THE FOREFRONT OF HEALTHCARE CHANGE