Astellas Pharma Inc. · TSE:4503
Astellas Pharma — Q2 2021 Earnings Presentation
44 slides from Astellas Pharma's earnings presentation, Oct 29, 2021
Slide 1: Q2/FY2021 Financial Results Ended September 30, 2021
Q2/FY2021 FINANCIAL RESULTS ENDED SEPTEMBER 30, 2021 Kenji Yasukawa, Ph.D. President and CEO Astellas Pharma Inc. October 29, 2021
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 Q2/FY2021 Consolidated Financial Results I FY2021 Revised Forecasts II Initiatives for Sustainable Growth
Slide 4: Q2/FY2021 Financial Results and FY2021 Revised Forecast: Overview
Q2/FY2021 FINANCIAL RESULTS AND 4 FY2021 REVISED FORECAST: OVERVIEW Revenue increased by 6%, Core OP decreased In line with assumptions of full-year forecast ⚫ Sales of XTANDI and Strategic products increased as expected, offsetting sales decrease due to termination of sales and distribution, transf
Slide 5: Q2/FY2021 Financial Results
Q2/FY2021 FINANCIAL RESULTS 5 Change FY21 (billion yen) Q2/FY20 Q2/FY21 Change Progress FX impact (%) FCST* Revenue 615.5 651.7 +36.2 +5.9% 1,323.0 49.3% +24.5 bil. yen Cost of sales 119.5 124.7 +5.2 +4.3% % of revenue 19.4% 19.1% -0.3 ppt SG&A expenses 242.1 270.5 +28.4 +11.7% 541.0 50.0% US XTANDI
Slide 6: Q2/FY2021 Financial Results: Revenue
Q2/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 Q2/FY20 Q2/FY21 Change Change (%) Revenue 615.5 bil. yen 651.7 bil. yen +36.2 bil. yen +5.9% Inc
Slide 7: Q2/FY2021 Financial Results: Sales of Main Products
Q2/FY2021 FINANCIAL RESULTS: 7 SALES OF MAIN PRODUCTS Q2/FY2021 Act and FY2021 FCST (billion yen) YoY: +42.1 (+19%) ✓ Double-digit growth in global sales and in line with forecast XTANDI ✓ In addition to US, sales expansion in EU following approval 267.6 Progress against FCST: 48% ✓ of M1 HSPC indic
Slide 8: Q2/FY2021 Financial Results: Cost Items
Q2/FY2021 FINANCIAL RESULTS: COST ITEMS 8 SG&A expenses increased YoY and slightly above full-year FCST R&D expenses increased YoY, but in line with full-year FCST Core basis: Main items for YoY and progress against FCST Cost of sales % of revenue ✓ Decrease mainly due to changes in product mix YoY:
Slide 9: FY2021 Revised Forecast: Overview
FY2021 REVISED FORECAST: OVERVIEW 9 ⚫ No changes have been made to Revenue ➢ Sales of XTANDI and Strategic products are on track ⚫ Costs ➢ SG&A expenses are slightly above full-year FCST but within controllable range for the full year ✓ Thorough budget control on a quarter basis ✓ Optimizing personn
Slide 10: FY2021 Revised Forecast
FY2021 REVISED FORECAST 10 ⚫ No changes have been made to Core basis FY2021 forecast ⚫ Downward revision of Full basis profit Previous FCST Revised FCST (billion yen) (Disclosed Change in July 2021) Operating profit 227.0 218.0 -9.0 Profit 183.0 174.0 -9.0
Slide 11: Agenda
AGENDA 11 Q2/FY2021 Consolidated Financial Results I FY2021 Revised Forecasts II Initiatives for Sustainable Growth
Slide 12: XTANDI & Strategic Products: Highlight (1/2)
XTANDI & STRATEGIC PRODUCTS: HIGHLIGHT (1/2) 12 Strategic products: XOSPATA, PADCEV, zolbetuximab, EVRENZO, fezolinetant, AT132 Key Events Expected in FY2021 Milestone Project / Product Indication / Clinical study Achieved Regulatory enzalutamide / XTANDI M1 hormone-sensitive prostate cancer (EU) Ap
Slide 13: XTANDI & Strategic Products: Highlight (2/2)
XTANDI & STRATEGIC PRODUCTS: HIGHLIGHT (2/2) 13 Strategic products: XOSPATA, PADCEV, zolbetuximab, EVRENZO, fezolinetant, AT132 Other Updates since the last financial results announcement Project / Product Indication Updated status enzalutamide / XTANDI M1 CSPC OS data of Phase 3 ARCHES study presen
Slide 14: Enzalutamide (XTANDI) (1/2): OS Data in Phase 3 ARCHES Study in M1 CSPC
ENZALUTAMIDE (XTANDI) (1/2): 14 OS DATA IN PHASE 3 ARCHES STUDY IN M1 CSPC OS data presented at ESMO 2021: reduced risk of death by 34% OS: Overall survival, M1 CSPC: Metastatic castration-sensitive prostate cancer, ESMO: European Society for Medical Oncology, ENZA: enzalutamide, ADT: Androgen depri
Slide 15: Enzalutamide (XTANDI) (2/2): Phase 3 Study Data by Disease Stage
ENZALUTAMIDE (XTANDI) (2/2): 15 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-che
Slide 16: Fezolinetant: Phase 3 Study Data
FEZOLINETANT: PHASE 3 STUDY DATA 16 12-week data of SKYLIGHT 2 study presented at NAMS 2021 52-week data of SKYLIGHT 1 study obtained <SKYLIGHT 2: Co-primary efficacy endpoints> All four co-primary endpoints were met Change from baseline in mean frequency of VMS Change from baseline in mean severity
Slide 17: AT132 (Resamirigene Bilparvovec): Updated Status
AT132 (RESAMIRIGENE BILPARVOVEC): 17 UPDATED STATUS ASPIRO study in XLMTM put on clinical hold by FDA, due to the incidence of an SAE and subsequent participant death ⚫ Received clinical hold letter from FDA in Sep 2021 ⚫ Additional participant data anticipated from the autopsy and follow-up analysi
Slide 18: Progress in Focus Area Approach (1/2): Clinical Proof and Expansion of Key Platforms
PROGRESS IN FOCUS AREA APPROACH (1/2): 18 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 Primary Focus Biology/Modality/Technology 1 FY21 FY22-23 FY24-25 aiming PoC Small molecule by end FY25
Slide 19: Progress in Focus Area Approach (2/2): Current Status in Primary Focus
PROGRESS IN FOCUS AREA APPROACH (2/2): 19 CURRENT STATUS IN PRIMARY FOCUS Primary Focus Biology/Modality/Technology 1 Project Current status AT132 (See the slides for “XTANDI and Strategic products”) Genetic Gene replacement (AAV) AT845 Phase 1 study ongoing Regulation Gene regulation (AAV) ASP1948
Slide 20: Progress in Rx+ Program (1/2)
PROGRESS IN Rx+ PROGRAM (1/2) 20 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 exercis
Slide 21: Progress in Rx+ Program (2/2): Partnering for ECG Testing Service
PROGRESS IN Rx+ PROGRAM (2/2): 21 PARTNERING FOR ECG TESTING SERVICE Total solution for early detection of atrial fibrillation using disposable Holter ECG device and AI-Based Analysis Service Disposable ECG device “EG Holter” Combination with ECG Analysis Service ⚫ Disposable and hygienic; 6 mm thic
Slide 22: Sustainability: Environment Initiatives
SUSTAINABILITY: 22 ENVIRONMENT INITIATIVES World’s first use of environmentally friendly biomass-based plastic for blister packages of drugs ⚫ The blister package is made of biomass-based plastic, polyethylene derived from sugarcane, as 50% of its raw material. It is an environmentally friendly pack
Slide 23: Progress Toward Achieving CSP2021
PROGRESS TOWARD ACHIEVING CSP2021 23 Revenue, Pipeline Value Core OP XTANDI and Strategic products: 1 5 Flat SG&A in absolute terms ✓ Investment for new product ¥1.2T in FY2025 launch Sufficient R&D investments ✓ Sales growth in line with ambitious forecast 6 ✓ Thorough budget control Core OP marg
Slide 24: Schedule
SCHEDULE 24 R&D meeting ➢ Dec 7th 2021, 15:30-16:45 (JST) - New research organization structure - ➢ Mar 9th 2022, 9:30-11:00 (JST) - Initiatives for gene therapy - Sustainability meeting ➢ Feb 28th 2022, 15:00-16:30 (JST)
Slide 25: Appendix
APPENDIX
Slide 26: Q2/FY2021: Revenue by Region
Q2/FY2021: REVENUE BY REGION 26 (billion yen) Q2/FY20 Q2/FY21 Change (%) Japan 144.2 130.5 -9.5% United States 236.7 270.1 +14.1% Established Markets 138.9 157.4 +13.3% Greater China 29.6 33.1 +11.8% International Markets 56.7 55.3 -2.5% Established Markets: Europe, Canada, Australia Greater China:
Slide 27: Q2/FY2021: Sales of Main Products
Q2/FY2021: SALES OF MAIN PRODUCTS 27 FY21 (billion yen) Q2/FY20 Q2/FY21 Change CER growth FCST* XTANDI 225.5 267.6 +18.7% +13.9% 554.1 XOSPATA 11.0 16.5 +50.3% +44.4% 35.4 PADCEV 6.0 9.1 +51.5% +47.6% 20.7 EVRENZO 0.3 1.4 +319.1% +316.7% 7.2 mirabegron 80.0 84.4 +5.5% +2.2% 176.3 Prograf 89.6 92.3 +
Slide 28: Q2/FY2021 Financial Results: Business Update for Main Products
Q2/FY2021 FINANCIAL RESULTS: 28 BUSINESS UPDATE FOR MAIN PRODUCTS Global sales increased steadily as expected and continuous strong growth is expected. In US, demand grew 15% YoY. In EU, reimbursement for M1 HSPC continues to expand (Germany, UK, XTANDI Spain Switzerland, Netherlands) supporting the
Slide 29: Q2/FY2021 Actual: FX Rate
Q2/FY2021 ACTUAL: FX RATE 29 Average rate for the period Currency Q2/FY20 Q2/FY21 Change USD 107 yen 110 yen +3 yen EUR 121 yen 131 yen +10 yen Change in closing rate from previous fiscal year end Currency Q2/FY20 Q2/FY21 USD -3 yen +1 yen EUR +5 yen -1 yen <Impact of exchange rate on financial resu
Slide 30: FY2021 Revised FCST: FX Rate & FX Sensitivity
FY2021 REVISED FCST： FX RATE & FX SENSITIVITY 30 Exchange rate FY2021 FY2021 Average for the period Initial FCST Revised FCST USD 110 yen 110 yen EUR 130 yen 130 yen Forecast rates from Q3/FY2021 onwards: 110 USD/yen, 130 EUR/yen Estimated FX sensitivity (Q3 and onward) of FY2021 revised forecasts b
Slide 31: Balance Sheet & Cash Flow Highlights
BALANCE SHEET & CASH FLOW HIGHLIGHTS 31 (billion yen) FY20 end Sep. 30, 2021 Total assets 2,273.6 2,261.5 Cash and cash equivalents 326.1 318.3 Total equity attributable to owners of the parent 1,386.1 1,417.6 Equity ratio (%) 61.0% 62.7% (billion yen) Q2/FY20 Q2/FY21 FY20 Cash flows from operating
Slide 32: Capital Allocation
CAPITAL ALLOCATION 32 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 33: Robust Pipeline of Astellas
ROBUST PIPELINE OF ASTELLAS 33 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) ASP1948 zolbetuximab gilteritinib (Pancreatic adenocarcinoma) (Earlier-stage AML, pediatric
Slide 34: Progress in Overall Pipeline
PROGRESS IN OVERALL PIPELINE 34 Phase 1 Entry to Approval since the Last Financial Results Announcement Phase 1 Entry Phase 2 Entry Phase 3 Entry Filing Approval ASP7517 roxadustat Acute myeloid leukemia Treatment of adult patients and myelodysplastic with symptomatic anemia syndromes associated wit
Slide 35: XTANDI & Strategic Products: Status Update
Strategic products: XOSPATA, PADCEV, zolbetuximab, EVRENZO, fezolinetant, AT132 XTANDI & STRATEGIC PRODUCTS: STATUS UPDATE 35 (Underlined: Updates since the last financial results announcement) Indication Current status enzalutamide / M1 CSPC • Global: Positive OS data in Phase 3 ARCHES study presen
Slide 36: Enzalutamide: Androgen Receptor Inhibitor
ENZALUTAMIDE: ANDROGEN RECEPTOR INHIBITOR 36 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 Surveillance R
Slide 37: Gilteritinib: FLT3 Inhibitor
GILTERITINIB: FLT3 INHIBITOR 37 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 Discontinued LACEWING due to the futility Relapsed or refractory Mo
Slide 38: Enfortumab Vedotin (EV): Nectin-4 Targeted ADC (1/3) Overall UC Program
ENFORTUMAB VEDOTIN (EV): NECTIN-4 TARGETED ADC (1/3) 38 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 39: Enfortumab Vedotin (EV) (2/3): Clinical Studies
ENFORTUMAB VEDOTIN (EV) (2/3): 39 CLINICAL STUDIES For urothelial cancer sBLA (to convert regular approval) approved in US in mUC, Platinum and PD-1/L1 inhibitor pretreated; P3: EV-301 n=608 Jul 2021. Approved in JP in Sep 2021. Filed in EU in EV mono vs. Chemo Mar 2021 mUC, Previously untreated, Pl
Slide 40: Enfortumab Vedotin (EV) (3/3): Study Data by Disease Stage of UC
ENFORTUMAB VEDOTIN (EV) (3/3): 40 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 41: Zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody
ZOLBETUXIMAB: 41 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 42: Fezolinetant: NK3 Receptor Antagonist
FEZOLINETANT: NK3 RECEPTOR ANTAGONIST 42 VMS has a significant negative impact on QoL Women’s Health Initiative (WHI) Study 2 ⚫ Physical symptoms include hot flashes and night sweats, ⚫ Initial data analyses showed an association between which can impact sleep. chronic HRT use and increased risk of
Slide 43: AT132 (Resamirigene Bilparvovec): rAAV8-Des-hMTM1
AT132 (RESAMIRIGENE BILPARVOVEC): 43 rAAV8-Des-hMTM1 Characteristics of AT132 X-linked myotubular myopathy (XLMTM) ⚫ Lead program in the gene therapy pipeline of ⚫ Rare neuromuscular disease with X-linked, Audentes Therapeutics, acquired by Astellas loss of function mutations in MTM1 gene in Jan 202
Slide 44: On the Forefront of Healthcare Change
ON THE FOREFRONT OF HEALTHCARE CHANGE