Astellas Pharma Inc. · TSE:4503
Astellas Pharma — Q3 2021 Earnings Presentation
41 slides from Astellas Pharma's earnings presentation, Feb 2, 2022
Slide 1: Q3/FY2021 Financial Results
Q3/FY2021 FINANCIAL RESULTS ENDED DECEMBER 31, 2021 Naoki Okamura Chief Strategy Officer and Chief Financial Officer, Chief Business Officer Astellas Pharma Inc. February 2, 2022
Slide 2: Cautionary Statement Regarding Forward-Looking Information
CAUTIONARY STATEMENT REGARDING FORWARD- 2 LOOKING 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 st
Slide 3: Agenda
AGENDA 3 I Q3/FY2021 Consolidated Financial Results II Initiatives for Sustainable Growth
Slide 4: Q3/FY2021 Financial Results: Overview
Q3/FY2021 FINANCIAL RESULTS: OVERVIEW 4 Revenue increased 6% YoY and is in line with full-year forecast Core OP increased 8% YoY and is above full-year forecast ⚫ Sales of XTANDI and Strategic products increased more than 20% YoY, in line with ambitious full-year forecast offsetting sales decrease d
Slide 5: Q3/FY2021 Financial Results
Q3/FY2021 FINANCIAL RESULTS 5 Change FY21 (billion yen) Q3/FY20 Q3/FY21 Change Progress FX impact (%) FCST* Revenue 940.9 992.3 +51.4 +5.5% 1,323.0 75.0% +42.8 bil. yen Cost of sales 187.7 194.1 +6.4 +3.4% % of revenue 20.0% 19.6% -0.4 ppt SG&A expenses 363.0 406.4 +43.4 +11.9% 541.0 75.1% US XTANDI
Slide 6: Q3/FY2021 Financial Results: Revenue
Q3/FY2021 FINANCIAL RESULTS: REVENUE 6 Revenue increase driven by growth of XTANDI and Strategic products, which offsets sales decrease due to termination of sales and distribution / transfer of products Q3/FY20 Q3/FY21 Change Change (%) Revenue 940.9 bil. yen 992.3 bil. yen +51.4 bil. yen +5.5% Inc
Slide 7: Q3/FY2021 Financial Results: Sales of Main Products
Q3/FY2021 FINANCIAL RESULTS: 7 SALES OF MAIN PRODUCTS Q3/FY2021 Act and FY2021 FCST (billion yen) ✓ Global sales increased 20% YoY, in line with forecast XTANDI YoY: +68.9 (+20%) ✓ In addition to US, sales expansion in EU following approval 411.6 Progress against FCST: 74% of M1 HSPC indication ✓ St
Slide 8: Q3/FY2021 Financial Results: Cost Items
Q3/FY2021 FINANCIAL RESULTS: COST ITEMS 8 SG&A expenses increased YoY and slightly above full-year FCST R&D expenses increased YoY and in line with full-year FCST Core basis: Main items for YoY and progress against FCST Cost of sales ✓ Decrease mainly due to changes in product mix % of revenue ✓ FX
Slide 9: Commercial Organization Reforms
COMMERCIAL ORGANIZATION REFORMS 9 Aiming to maximize VALUE by pursuing optimal commercial organization to achieve CSP2021 goals Changes in the product portfolio Changes in business environment • Changes in contact methods due to spread of • Shift to specialty products COVID-19 • Expansion of virtual
Slide 10: FY2021 Full-Year Outlook
FY2021 FULL-YEAR OUTLOOK 10 ⚫ YoY Revenue increase is on track driven by XTANDI and Strategic products ⚫ SG&A expenses are slightly above full-year FCST but aiming to control for the full year ➢ Thorough budget control on a quarter basis ➢ Starting to realize impact of global personnel optimization
Slide 11: Agenda
AGENDA 11 I Q3/FY2021 Consolidated Financial Results II Initiatives for Sustainable Growth
Slide 12: XTANDI & Strategic Products: Highlight (1/2)
XTANDI & STRATEGIC PRODUCTS: HIGHLIGHT (1/2) 12 (Red: Updates since the last financial results announcement) Key Events Expected in FY2021 Milestone Project / Product Indication / Clinical study Achieved Regulatory enzalutamide / XTANDI M1 hormone-sensitive prostate cancer (EU) Apr 2021 decision enf
Slide 13: XTANDI & Strategic Products: Highlight (2/2)
XTANDI & STRATEGIC PRODUCTS: HIGHLIGHT (2/2) 13 Other Updates since the last financial results announcement Project / Product Indication Updated status enzalutamide / XTANDI M1 CSPC Filed label update to include the OS data in US and EU in Dec 2021 gilteritinib / XOSPATA AML, post-HSCT Filing timeli
Slide 14: Gilteritinib: Development Status
GILTERITINIB: DEVELOPMENT STATUS 14 New study in newly diagnosed and high intensity chemotherapy-ineligible AML to start PASHA (HOVON) PrE0905 (PrECOG) Chemo Maintenance ADMIRAL High- consolidation GOSSAMER intensity induction Maintenance chemo Transplant MORPHO Salvage therapy FLT3 mut+ AML Launche
Slide 15: Progress in Focus Area Approach (1/3): Clinical Proof and Expansion of Key Platforms
PROGRESS IN FOCUS AREA APPROACH (1/3): 15 CLINICAL PROOF AND EXPANSION OF KEY PLATFORMS Primary Focuses have robust pipeline to newly build Post-PoC portfolio by end FY2025 No. of projects Modality aiming PoC Small molecule Primary Focus Biology/Modality/Technology 1 FY21 FY22-23 FY24-25 by end FY25
Slide 16: Progress in Focus Area Approach (2/3): Current Status in Primary Focus
PROGRESS IN FOCUS AREA APPROACH (2/3): CURRENT STATUS IN PRIMARY FOCUS 16 (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 Gene replacement (AAV) Completed dosing
Slide 17: Progress in Focus Area Approach (3/3): ASP2138
PROGRESS IN FOCUS AREA APPROACH (3/3): 17 ASP2138 The lead program of bispecific immune cell engager to enter clinical phase Characteristics of ASP2138 ⚫ Bispecific antibody targeting Claudin 18.2 and CD3 ✓ Forms a synapse between Claudin 18.2 expressing cancer cells and CD3 positive T cells and kil
Slide 18: Progress in Rx+ Program
PROGRESS IN Rx+ PROGRAM 18 Key events expected in FY2021 (announced in Apr 2021) Sphere * Program Event Achieved Chronic disease Fit-eNce Initiation of pilot marketing for Sep 2021 progression at-home service (Fit-eNce Home) prevention Game application for Initiation of pilot marketing exercise supp
Slide 19: Progress Toward Achieving CSP2021
PROGRESS TOWARD ACHIEVING CSP2021 19 Revenue, Pipeline Value Core OP XTANDI and Strategic products: ✓ Investment for new product 1 ¥1.2T in FY2025 5 Flat SG&A in absolute terms launch Sufficient R&D investments ✓ Thorough budget control ✓ Sales growth in line with ambitious forecast 6 Core OP marg
Slide 20: Schedule: Sustainability Meeting and R&D Meeting
SCHEDULE 20 Sustainability Meeting ➢ Feb 28th 2022, 15:00-16:30 (JST) R&D Meeting ➢ Mar 9th 2022, 9:30-11:00 (JST) - Initiatives for gene therapy -
Slide 21: Appendix
APPENDIX
Slide 22: Gain on Divestiture of Intangible Assets
GAIN ON DIVESTITURE OF INTANGIBLE ASSETS 22 ⚫ P/L has a new account from Q3/FY2021: Gain on divestiture of intangible assets • This account includes gain on sale of rights of in-market products or pipeline assets from Q3 onward • Included this account as a core basis performance • Upfront payment an
Slide 23: Q3/FY2021: Revenue by Region
Q3/FY2021: REVENUE BY REGION 23 (billion yen) Q3/FY20 Q3/FY21 Change (%) Japan 221.8 203.2 -8.4% United States 355.8 407.9 +14.7% Established Markets 218.0 239.2 +9.8% Greater China 43.8 50.3 +14.8% International Markets 87.6 83.0 -5.3% Established Markets: Europe, Canada, Australia Greater China: C
Slide 24: Q3/FY2021: Sales of Main Products
Q3/FY2021: SALES OF MAIN PRODUCTS 24 FY21 (billion yen) Q3/FY20 Q3/FY21 Change CER growth FCST* XTANDI 342.7 411.6 +20.1% +14.4% 554.1 XOSPATA 17.6 25.7 +45.8% +39.0% 35.4 PADCEV 9.4 14.6 +55.7% +49.0% 20.7 EVRENZO 0.7 2.1 +198.6% +197.5% 7.2 mirabegron 122.3 126.9 +3.8% -0.3% 176.3 Prograf 138.3 14
Slide 25: Q3/FY2021 Financial Results: Business Update for Main Products
Q3/FY2021 FINANCIAL RESULTS: 25 BUSINESS UPDATE FOR MAIN PRODUCTS Global sales increased steadily as expected given the ongoing focus on recent M1 HSPC launches and continuous strong growth is expected. In the US, demand grew +15% YoY. In Europe, XTANDI reimbursement for M1 HSPC continues to expand
Slide 26: Q3/FY2021 Actual: FX Rate
Q3/FY2021 ACTUAL: FX RATE 26 Average rate for the period Currency Q3/FY20 Q3/FY21 Change USD 106 yen 111 yen +5 yen EUR 122 yen 131yen +8 yen Change in closing rate from previous fiscal year end Currency Q3/FY20 Q3/FY21 USD -5 yen +4 yen EUR +7 yen +1 yen <Impact of exchange rate on financial result
Slide 27: FY2021 FCST: FX Rate & FX Sensitivity
FY2021 FCST： FX RATE & FX SENSITIVITY 27 Exchange rate FY21 Average for the period Forecast USD 110 yen EUR 130 yen Forecast rates from Q3/FY2021 onward: 110 USD/yen, 130 EUR/yen Estimated FX sensitivity (Q3 onward) of FY2021 forecasts by 1 yen appreciation* Year-end rate Average rate 1 yen higher t
Slide 28: Balance Sheet & Cash Flow Highlights
BALANCE SHEET & CASH FLOW HIGHLIGHTS 28 (billion yen) FY20 end Dec. 31, 2021 Total assets 2,273.6 2,356.2 Cash and cash equivalents 326.1 350.2 Total equity attributable to owners of the parent 1,386.1 1,466.3 Equity ratio (%) 61.0% 62.2% (billion yen) Q3/FY20 Q3/FY21 FY20 Cash flows from operating
Slide 29: Capital Allocation
CAPITAL ALLOCATION 29 1 Top priority is investment 2 Raise dividend level aligned 3 Flexibly execute share for business growth with profit / cashflow plan buyback by excess cash and actual performance throughout CSP2021 period Aiming for higher level of dividends increase during CSP2021 aligned with
Slide 30: Robust Pipeline of Astellas
ROBUST PIPELINE OF ASTELLAS 30 Phase 1 Phase 2 Phase 3 Filed enfortumab vedotin enfortumab vedotin enzalutamide enfortumab vedotin (NMIBC) (Other solid tumors) (M0 CSPC, M1 CSPC: China) (mUC, pretreated: EU) gilteritinib zolbetuximab gilteritinib (Newly diagnosed AML, HIC-ineligible) (Pancreatic ade
Slide 31: Progress in Overall Pipeline
PROGRESS IN OVERALL PIPELINE 31 Phase 1 Entry to Approval since the Last Financial Results Announcement Phase 1 Entry Phase 2 Entry Phase 3 Entry Filing Approval gilteritinib Newly diagnosed AML, high-intensity chemotherapy-ineligible ASP2138 gastric and GEJ adenocarcinoma, pancreatic adenocarcinoma
Slide 32: XTANDI & Strategic Products: Status Update
XTANDI & STRATEGIC PRODUCTS: STATUS UPDATE 32 (Red: Updates since the last financial results announcement) Indication Current status enzalutamide / M1 CSPC • US & EU: Filed label update to include the OS data in Dec 2021 XTANDI • China: Phase 3 study ongoing (enrollment completed) M0 CSPC • Phase 3
Slide 33: Enzalutamide (1/2): Androgen Receptor Inhibitor
ENZALUTAMIDE (1/2): 33 ANDROGEN RECEPTOR INHIBITOR US/EU/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 Surveill
Slide 34: Enzalutamide (2/2): Phase 3 Study Data by Disease Stage
ENZALUTAMIDE (2/2): 34 PHASE 3 STUDY DATA BY DISEASE STAGE Continued potential in earlier lines with consistent survival benefit and longer duration of treatment Early stage Late stage Disease Castration-sensitive (CSPC) Castration-resistant (CRPC) stage M1 M1 M0 M1 M0 (pre-chemo) (post-chemo) Phase
Slide 35: Gilteritinib: FLT3 Inhibitor
GILTERITINIB: FLT3 INHIBITOR 35 PASHA (HOVON) PrE0905 (PrECOG) Chemo Maintenance ADMIRAL High- consolidation GOSSAMER intensity induction Maintenance chemo Transplant MORPHO Salvage therapy FLT3 mut+ AML Launched Low-intensity chemo P1 (triplet) Monotherapy vs. salvage Relapsed or refractory P3: ADM
Slide 36: Enfortumab Vedotin (1/3): Nectin-4 Targeted ADC Overall UC Program
ENFORTUMAB VEDOTIN (EV) (1/3): NECTIN-4 TARGETED ADC 36 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 37: Enfortumab Vedotin (2/3): Clinical Studies
ENFORTUMAB VEDOTIN (EV) (2/3): 37 CLINICAL STUDIES For urothelial cancer sBLA (to convert regular approval) approved in US in Jul mUC, Platinum and PD-1/L1 inhibitor pretreated; P3: EV-301 n=608 2021. Approved in JP in Sep 2021. CHMP positive EV mono vs. Chemo opinion received in Dec 2021 mUC, Previ
Slide 38: Enfortumab Vedotin (3/3): Study Data by Disease Stage of UC
ENFORTUMAB VEDOTIN (EV) (3/3): 38 STUDY DATA BY DISEASE STAGE OF UC Early stage Late stage MIBC mUC Disease Surgery eligible Previously untreated (first line) PD-1/L1 inhibitor pretreated stage Platinum naïve Cis- Cis- Platinum Cis-ineligible and Platinum pretreated eligible ineligible eligible cis-
Slide 39: Zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody
ZOLBETUXIMAB: 39 ANTI-CLAUDIN 18.2 MONOCLONAL ANTIBODY Target: Claudin 18.2 Gastric and (GEJ) adenocarcinoma ⚫ Claudin is a major structural component of tight ⚫ Target patient population: junctions and seals intercellular space in epithelial HER2-, Claudin 18.2+ locally advanced and sheets metastat
Slide 40: Fezolinetant: NK3 Receptor Antagonist
FEZOLINETANT: NK3 RECEPTOR ANTAGONIST 40 VMS has a significant negative impact on Women’s Health Initiative (WHI) Study 2 QoL ⚫ Initial data analyses showed an association between chronic HRT ⚫ Physical symptoms include hot flashes and night use and increased risk of cardiovascular disease and breas
Slide 41: On the Forefront of Healthcare Change
ON THE FOREFRONT OF HEALTHCARE CHANGE