Astellas Pharma Inc. · TSE:4503
Astellas Pharma — Q1 2020 Earnings Presentation
44 slides from Astellas Pharma's earnings presentation, Aug 4, 2020
Slide 1: Q1/FY2020 Financial Results Ended June 30, 2020
Q1/FY2020 FINANCIAL RESULTS ENDED JUNE 30, 2020 Naoki Okamura Representative Director, Corporate Executive Vice President, Chief Strategy Officer and Chief Financial Officer Astellas Pharma Inc. August 4, 2020
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 Q1/FY2020 Consolidated Financial Results I and FY2020 Revised Forecasts II Initiatives for Sustainable Growth III Capital Allocation
Slide 4: Q1/FY2020 Financial Results: Overview
Q1/FY2020 FINANCIAL RESULTS: OVERVIEW 4 Revenue and Core OP decreased overall Sales of growth drivers steadily increased In particular, sales of XTANDI and PADCEV exceeded expectations; growth of main products offset most of the sales decreases from termination of sales and distribution in Japan a
Slide 5: Q1/FY2020 Financial Results
Q1/FY2020 FINANCIAL RESULTS 5 Change Change (billion yen) Q1/FY19 Q1/FY20 CER growth (amount) (%) Revenue 334.1 307.0 -27.2 -8.1% -6.0% Cost of sales 70.5 59.7 -10.9 -15.4% % of revenue 21.1% 19.4% SG&A expenses 117.5 120.8 +3.3 +2.8% R&D expenses 53.5 57.3 +3.8 +7.1% Amortisation of intangible asse
Slide 6: Q1/FY2020 Financial Results: Revenue
Q1/FY2020 FINANCIAL RESULTS: REVENUE 6 Growth of main products offset most of the sales decreases from termination of sales and distribution in Japan and LOE Q1/FY19 Q1/FY20 Change Revenue 334.1 bil. yen 307.0 bil. yen -27.2 bil. yen Sales increases in main products XTANDI, XOSPATA, PADCEV, mirabegr
Slide 7: Q1/FY2020 Financial Results: Sales of Main Products
Q1/FY2020 FINANCIAL RESULTS: 7 SALES OF MAIN PRODUCTS Q1/FY2020 sales XTANDI Record quarterly sales Demand grew in excess of 30% in US 112.0 billion yen +16.0 (+17%) Approved additional indication in Japan in May 2020 XOSPATA In addition to Japan and US, 5.6 billion yen +3.2 (+128%) contribu
Slide 8: Q1/FY2020 Financial Results: Cost Items
Q1/FY2020 FINANCIAL RESULTS: COST ITEMS 8 Core basis: Year-on-Year comparison Cost of sales % of revenue Decrease mainly due to changes in product mix (FX impact on elimination of unrealized gain: Increase in COGs ratio (+1.1ppt)) 1.7ppt decrease 4.8% decrease, excluding increased XTANDI co-prom
Slide 9: FY2020 Revised Forecast
FY2020 REVISED FORECAST 9 Downward revision of initial forecasts for revenue and core OP Reflect the latest business outlook: Upward revision of sales forecasts for main products in oncology area due to continuously robust growth trend Reflect the impact of COVID-19: Downward revision of forec
Slide 10: FY2020 Revised Forecast: Factors of Revision
FY2020 REVISED FORECAST: FACTORS OF REVISION 10 Revenue Core OP Variance from -25.5 bil. yen -6.0 bil. yen initial forecast (Breakdown) Latest business +13.0 bil. yen +8.5 bil. yen outlook • Favorable sales of XTANDI US • Profit increase due to upward revision of sales and PADCEV • Efficient managem
Slide 11: FY2020 Revised Forecast: Outlook from Q2/FY2020 Onwards
FY2020 REVISED FORECAST: 11 OUTLOOK FROM Q2/FY2020 ONWARDS Smaller downward revision of revenue In addition to steady growth of main products in oncology area, the impact of COVID-19, which was significant in Q1, to be moderate Upward revision of Core OP More than offsetting revenue decrease by
Slide 12: Agenda
AGENDA 12 Q1/FY2020 Consolidated Financial Results I and FY2020 Revised Forecasts II Initiatives for Sustainable Growth III Capital Allocation
Slide 13: Key Post-PoC Projects: Status Update
KEY POST-POC PROJECTS: STATUS UPDATE 13 (Underlined: Updates since FY2019 financial results announcement in May 2020) enzalutamide gilteritinib enfortumab vedotin M0 CRPC Relapsed or refractory Metastatic urothelial cancer • Phase 3 study OS data published in acute myeloid leukemia • Previously untr
Slide 14: Enzalutamide: Phase 3 Study Data by Disease Stage
ENZALUTAMIDE: 14 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 3 EMB
Slide 15: Roxadustat: MAA Submission
ROXADUSTAT: MAA SUBMISSION 15 Filed in EU for the treatment of anemia in adult patients with chronic kidney disease (CKD) both dialysis dependent (DD) and non-dialysis dependent (NDD), based on the data of 8 Phase 3 studies involving more than 9,000 patients Proved to be efficacious in increasing
Slide 16: AT132 (Resamirigene Bilparvovec): Current Status
AT132 (RESAMIRIGENE BILPARVOVEC): Genetic Regulation 16 CURRENT STATUS Clinical study for registration of AT132 in XLMTM patients put on clinical hold by FDA, due to recently observed serious adverse events No. of subjects enrolled Study cohort AT132 dose (n=26 in total) Treated Untreated 1 x 1014 v
Slide 17: COVID-19 Impact on Clinical Development (1/2)
COVID-19 IMPACT ON CLINICAL DEVELOPMENT (1/2) 17 We have started to reactivate clinical studies in the countries such as US, EU, and Japan, where the activities were suspended due to COVID-19 pandemic, following the benefit-risk assessment of each study, while delay in the timeline might be caused
Slide 18: COVID-19 Impact on Clinical Development (2/2)
COVID-19 IMPACT ON CLINICAL DEVELOPMENT (2/2) 18 Major project-specific impact Project Study / Milestone COVID-19 impact enzalutamide Regulatory decision • Delayed, because the EMA’s GCP inspection was postponed due to COVID-19; regulatory in EU for M1 CSPC decision originally expected in early FY20
Slide 19: Key Events Expected in FY2020
KEY EVENTS EXPECTED IN FY2020 19 Regulatory enzalutamide M1 CSPC (EU) decision M0 CRPC (China) M0 CRPC, label update to include the OS data (US, EU) roxadustat Anemia associated with chronic kidney disease, non-dialysis (JP) Data enfortumab Phase 2 EV-201 study cohort 2 in metastatic urothelial canc
Slide 20: ASP8062 for Opioid Use Disorder (OUD)
ASP8062 FOR OPIOID USE DISORDER (OUD) 20 NIH awards grant to fund early clinical studies of ASP8062, GABAB PAM, to investigate potential novel therapeutic approach to address the opioid crisis Opioid crisis in US GABAB PAM The White House declared the opioid crisis “Ten most wanted” pharmacologi
Slide 21: Progress in Rx+ Program: Fit-eNce
Chronic PROGRESS IN Rx+ PROGRAM: disease progression 21 prevention Fit-eNce - NEW STYLE FITNESS SERVICE As the first program of Rx+ business, pilot marketing of a scientifically evidenced exercise support service scheduled to start Developed scientifically based exercise programs through industry-
Slide 22: Agenda
AGENDA 22 Q1/FY2020 Consolidated Financial Results I and FY2020 Revised Forecasts II Initiatives for Sustainable Growth III Capital Allocation
Slide 23: Capital Allocation
CAPITAL ALLOCATION 23 Top priority is investment for strategic business growth FY15 FY16 FY17 FY18 FY19 FY20 Pursue business development opportunities in line with our strategy (yen) Dividends to be increased 40 Dividends per Share continuously based on 30 20 38 40 42 mid-and long-term growth 10
Slide 24: Appendix
APPENDIX
Slide 25: Accounting Treatment of Business Combination with Audentes
ACCOUNTING TREATMENT OF BUSINESS 25 COMBINATION WITH AUDENTES Revised fair value measurement of Audentes balance sheet at acquisition date (as of Jan 15, 2020) FY19 end consolidated balance sheet retrospectively revised <As of Mar 31, 2020> ($ million) <As of Jun 30, 2020 *> ($ million) Other assets
Slide 26: Q1/FY2020: Revenue by Region
Q1/FY2020: REVENUE BY REGION 26 (billion yen) Q1/FY19 Q1/FY20 Change (%) Japan 98.5 77.8 -21.0% United States 105.3 117.2 +11.3% Established Markets 75.8 64.0 -15.5% Greater China 14.7 14.2 -3.4% International 34.2 30.2 -11.8% Established Markets: Europe, Canada, Australia Greater China: China, Hong
Slide 27: Q1/FY2020: Sales of Main Products
Q1/FY2020: SALES OF MAIN PRODUCTS 27 FY20 FY20 (billion yen) Q1/FY19 Q1/FY20 Change CER growth Initial Revised FCST * FCST ** XTANDI 96.0 112.0 +16.6% +19.7% 459.3 464.6 XOSPATA 2.5 5.6 +128.3% +133.1% 23.2 23.1 PADCEV - 3.0 - - 13.0 OAB products 53.5 48.1 -10.0% -8.2% 204.9 197.9 mirabegron 39.9 40
Slide 28: FY2020 Revised Forecast
FY2020 REVISED FORECAST 28 FY20 FY20 (billion yen) Change Initial FCST Revised FCST Revenue 1,282.0 1,256.5 -25.5 R&D expenses 239.0 233.5 -5.5 Core operating profit 257.0 251.0 -6.0 Core profit 206.0 200.5 -5.5 <Full basis> Operating profit 252.0 246.5 -5.5 Profit 202.0 197.5 -4.5
Slide 29: Q1/FY2020 Actual: FX Rate
Q1/FY2020 ACTUAL: FX RATE 29 Average rate for the period Currency Q1/FY19 Q1/FY20 Change USD 110 yen 108 yen -2 yen EUR 123 yen 118 yen -5 yen Change in closing rate from previous fiscal year end Currency Q1/FY19 Q1/FY20 USD -3 yen -1 yen EUR -2 yen +2 yen <Impact of exchange rate on financial resul
Slide 30: FY2020 Revised Forecast: FX Rate & FX Sensitivity
FY2020 REVISED FCST： FX RATE & FX SENSITIVITY 30 Exchange rate (yen) FY20 FY20 Average for the period Initial FCST Revised FCST USD 110 yen 109 yen EUR 120 yen 120 yen Forecast rates from Q2/FY2020 onwards: 110 USD/yen, 120 EUR/yen Estimated FX sensitivity (Q2 and onward) of FY2020 revised forecasts
Slide 31: Balance Sheet & Cash Flow Highlights
BALANCE SHEET & CASH FLOW HIGHLIGHTS 31 (billion yen) FY19 end Jun 30, 2020 Total assets 2,315.2 2,256.0 Cash and cash equivalents 318.4 239.9 Total equity attributable to owners of the parent 1,289.2 1,306.7 Equity ratio (%) 55.7% 57.9% (billion yen) Q1/FY19 Q1/FY20 FY19 Cash flows from operating a
Slide 32: Details of Shareholder Returns
DETAILS OF SHAREHOLDER RETURNS 32 (yen) (billion yen) Dividends per Share* (left axis) Profit** (right axis) 250 2,500 40 2,000 200 30 150 1,500 42 20 40 38 100 1,000 10 50 500 0 00 (billion yen) FY05 FY06 FY07 FY08 FY09 FY10 FY11 FY12 FY13 FY14 FY15 FY16 FY17 FY18 FY19 FY20 (FCST) Total dividends 3
Slide 33: Filing Opportunities Announced in Strategic Plan 2018
FILING OPPORTUNITIES 33 ANNOUNCED IN STRATEGIC PLAN 2018 As of Aug 2020 enzalutamide M0 CSPC ✓✓✓: Approved ✓✓: Filed zolbetuximab Gastric and gastroesophageal ✓: Data obtained, enzalutamide junction adenocarcinoma filing under preparation M1 CSPC ✓✓✓ gilteritinib (US, JP) AML (Post-HSCT maintenance)
Slide 34: Robust Pipeline of Astellas
ROBUST PIPELINE OF ASTELLAS 34 Phase 1 Phase 2 Phase 3 Filed ASP1235/AGS62P1 zolbetuximab enzalutamide enzalutamide (Pancreatic adenocarcinoma) (M0 CSPC, M1 CSPC: China) (M1 CSPC: EU) ASP8374/PTZ-201 ASP1650 (Testicular cancer) gilteritinib enzalutamide ASP1948/PTZ-329 (Earlier-stage AML, Pediatric
Slide 35: Progress in Overall Pipeline
PROGRESS IN OVERALL PIPELINE 35 Phase 1 entry to approval since FY2019 financial results announcement in May 2020 Phase 1 Entry Phase 2 Entry Phase 3 Entry Filing Approval roxadustat solifenacin Anemia in adult Neurogenic detrusor patients with overactivity in chronic kidney pediatric patients disea
Slide 36: Enzalutamide: Androgen Receptor Inhibitor
ENZALUTAMIDE: ANDROGEN RECEPTOR INHIBITOR 36 US/EU/JP Definitive Therapy Castration-Sensitive Castration-Resistant ARCHES M1 CSPC newly-diagnosed Initial M1 CSPC PREVAIL AFFIRM Diagnosis Surgery recurrent M1 CRPC M1 CRPC Launched (1st line) (lines 2+) Salvage in US & JP Launched Launched Active File
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 LACEWING Monotherapy vs salvage Launched in US, JP, and EU Relapsed
Slide 38: Enfortumab Vedotin (EV): Nectin-4 Targeted ADC (1/3)
ENFORTUMAB VEDOTIN (EV): 38 NECTIN-4 TARGETED ADC (1/3) Treatment landscape for metastatic urothelial cancer and clinical studies for EV Platinum or Platinum and mUC patient Previously untreated PD-1/L1 inhibitor PD-1/L1 inhibitor treatment (first line) pretreated pretreated Cis-eligible: Platinum p
Slide 39: Enfortumab Vedotin (EV) (2/3): Clinical Studies
ENFORTUMAB VEDOTIN (EV) (2/3): CLINICAL STUDIES 39 For urothelial cancer mUC, Platinum and PD-1/L1 inhibitor pretreated; vs. P3: EV-301 n=608 Enrollment completed chemotherapy Locally advanced or mUC, Previously untreated, P3: EV-302 n=1,095 FSFT: Apr 2020 Platinum-eligible; EV + Pembro +/- Platinum
Slide 40: Enfortumab Vedotin (EV) (3/3): Phase 1b/2 EV-103 Study Design
ENFORTUMAB VEDOTIN (EV) (3/3): 40 PHASE 1b/2 EV-103 STUDY DESIGN Dose Escalation Cohort Dose Expansion Cohorts Recommended Cohort A Cohort D Cohort G EV dose EV + Pembro EV + Pembro EV + Cis, 1L EV + Cis/Carbo Locally Cis-ineligible Cis-ineligible + Pembro advanced 1L or 2L 1L Cohort E 1L or metasta
Slide 41: Zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody
ZOLBETUXIMAB: 41 ANTI-CLAUDIN 18.2 MONOCLONAL ANTIBODY Target: Claudin 18.2 Gastric and gastroesophageal junction • Claudin is a major structural component of tight (GEJ) adenocarcinoma junctions and seals intercellular space in • Target patient population: locally advanced and epithelial sheets met
Slide 42: Fezolinetant: NK3 Receptor Antagonist
FEZOLINETANT: NK3 RECEPTOR ANTAGONIST 42 VMS has a significant negative impact on Women’s Health Initiative (WHI) Study 2 quality of life • Physical symptoms include hot flashes and • Initial data analyses showed an association sweating/night sweats, which can impact sleep. between chronic HRT use a
Slide 43: AT132 (Resamirigene Bilparvovec): rAAV8-Des-hMTM1
AT132 (RESAMIRIGENE BILPARVOVEC): Genetic Regulation 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 M
Slide 44: On the Forefront of Healthcare Change
ON THE FOREFRONT OF HEALTHCARE CHANGE