Astellas Pharma Inc. · TSE:4503
Astellas Pharma — Q3 FY2020 Earnings Presentation
38 slides from Astellas Pharma's earnings presentation, Jan 29, 2021
Slide 1: Q3/FY2020 Financial Results Ended December 31, 2020
Q3/FY2020 FINANCIAL RESULTS ENDED DECEMBER 31, 2020 Naoki Okamura Executive Vice President, Chief Strategy Officer and Chief Financial Officer Astellas Pharma Inc. January 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 I Q3/FY2020 Consolidated Financial Results II Initiatives for Sustainable Growth
Slide 4: Q3/FY2020 Financial Results: Overview
Q3/FY2020 FINANCIAL RESULTS: OVERVIEW 4 Revenue and profit are in line with assumptions of full-year forecast ⚫ Revenue and Core operating profit decreased, YoY ⚫ Sales of growth drivers steadily increased ⚫ Spending of SG&A and R&D expenses is on track ⚫ No changes have been made to FY2020 forecast
Slide 5: Q3/FY2020 Financial Results
Q3/FY2020 FINANCIAL RESULTS 5 Change FY20 (billion yen) Q3/FY19 Q3/FY20 Change Progress (%) FCST Revenue 988.5 940.9 -47.6 -4.8% 1,256.5 74.9% Cost of sales 221.6 187.7 -33.9 -15.3% % of revenue 22.4% 20.0% -2.5 ppt SG&A expenses 353.6 363.0 +9.5 +2.7% R&D expenses 159.8 168.8 +9.1 +5.7% 233.5 72.3%
Slide 6: Q3/FY2020 Financial Results: Revenue
Q3/FY2020 FINANCIAL RESULTS: REVENUE 6 Main oncology products continue to grow strongly Q3/FY2020 actual (billion yen) YoY XTANDI 342.7 +44.8 XOSPATA 17.6 +7.9 Total sales of 3 oncology products, YoY PADCEV 9.4 +9.4 +62.1 billion yen mirabegron 122.3 +1.3 New products in Japan 54.1 +8.7 Consolidated
Slide 7: Q3/FY2020 Financial Results: Business Update for Main Products
Q3/FY2020 FINANCIAL RESULTS: 7 BUSINESS UPDATE FOR MAIN PRODUCTS Global sales are in line with forecast. In US, progress against forecast is slightly behind due to the impact of COVID-19 (slowdown of new patient starts), but demand grew in excess of 20% YoY and continued growth is XTANDI expected. I
Slide 8: Q3/FY2020 Financial Results: Cost Items
Q3/FY2020 FINANCIAL RESULTS: COST ITEMS 8 Spending of SG&A and R&D expenses is on track to full-year forecast Core basis: main items for, YoY Cost of sales % of revenue ✓ Decrease mainly due to changes in product mix 2.5 ppt decrease (FX impact on elimination of unrealized gain: Increase in COGs rat
Slide 9: Agenda
AGENDA 9 I Q3/FY2020 Consolidated Financial Results II Initiatives for Sustainable Growth
Slide 10: Key Post-PoC Projects: Status Update
KEY POST-POC PROJECTS: STATUS UPDATE 10 (Underlined: Updates since Q2/FY2020 Financial Results Announcement in Oct 2020) enzalutamide enfortumab vedotin zolbetuximab M0 CRPC mUC Gastric & GEJ adenocarcinoma • Filed in EU in Jun 2020 for • Previously treated: • Phase 3 studies ongoing label update to
Slide 11: Fezolinetant: Phase 3 Status
FEZOLINETANT: PHASE 3 STATUS 11 Three Phase 3 studies in US and EU are progressing well Two pivotal studies Long-term safety study (SKYLIGHT 1 and SKYLIGHT 2) (SKYLIGHT 4) fezolinetant fezolinetant Placebo 12w 30 mg 45 mg (DB) n=150 n=150 n=150 fezolinetant fezolinetant Placebo 52w 30 mg 45 mg (DB)
Slide 12: Progress in Focus Area Approach: Immuno-Oncology Programs
PROGRESS IN FOCUS AREA APPROACH: 12 IMMUNO-ONCOLOGY PROGRAMS - Partnership with KaliVir to discover and develop intravenously administered oncolytic virus - Expanding aAVC platform: Phase 1 study initiation for ASP0739 & ASP7517 in solid tumors VET2-L2 from aAVC platform KaliVir Immunotherapeutics ⚫
Slide 13: Progress in Rx+ Program: Development of Theranostics
PROGRESS IN Rx+ PROGRAM: DEVELOPMENT OF “THERANOSTICS*”; 13 INTEGRATION OF DIAGNOSTICS AND THERAPEUTICS Research collaboration on targeted radiation therapy with Actinium Pharmaceuticals Development of target-specific radioisotope diagnostics and therapeutics in parallel ⚫ Realize personalized medic
Slide 14: Sustainability: Support for TCFD Recommendation
SUSTAINABILITY: 14 SUPPORT FOR TCFD RECOMMENDATION Commitment to climate change issues in corporate strategy Our approach to environment issues - 2017 2018 2020 2021 Kerry plant： GHG reduction Purchasing Support for TCFD CSP incorporating Wind turbine, targets approved electricity from recommendatio
Slide 15: Schedule
SCHEDULE 15 Apr 27th, 2021: Financial Results for FY2020 May 26th, 2021: New Corporate Strategic Plan
Slide 16: Appendix
APPENDIX
Slide 17: Q3/FY2020: Revenue by Region
Q3/FY2020: REVENUE BY REGION 17 (billion yen) Q3/FY19 Q3/FY20 Change (%) Japan 276.2 221.8 -19.7% United States 331.9 355.8 +7.2% Established Markets 218.0 218.0 -0.0% Greater China 44.4 43.8 -1.2% International 102.8 87.6 -14.8% Established Markets: Europe, Canada, Australia Greater China: China, H
Slide 18: Q3/FY2020: Sales of Main Products
Q3/FY2020: SALES OF MAIN PRODUCTS 18 FY20 (billion yen) Q3/FY19 Q3/FY20 Change CER growth FCST* XTANDI 297.9 342.7 +15.0% +16.2% 464.6 XOSPATA 9.8 17.6 +80.7% +83.3% 23.1 PADCEV 0.0 9.4 - - 13.0 OAB products 157.2 147.0 -6.5% -5.5% 197.9 mirabegron 121.0 122.3 +1.0% +2.3% 167.9 Vesicare 36.2 24.7 -3
Slide 19: Q3/FY2020 Actual: FX Rate
Q3/FY2020 ACTUAL: FX RATE 19 Average rate for the period Currency Q3/FY19 Q3/FY20 Change USD 109 yen 106 yen -3 yen EUR 121 yen 122 yen +1 yen Change in closing rate from previous fiscal year end Currency Q3/FY19 Q3/FY20 USD -1 yen -5 yen EUR -2 yen +7 yen <Impact of exchange rate on financial resul
Slide 20: FY2020 Forecast: FX Rate & FX Sensitivity
FY2020 FCST： FX RATE & FX SENSITIVITY 20 Exchange rate (yen) FY20 FCST Average for the period USD 109 yen EUR 120 yen Forecast rates from Q2/FY2020 onwards: 110 USD/yen, 120 EUR/yen Estimated FX sensitivity (Q2 and onward) of FY2020 revised forecasts by 1 yen appreciation * Year-end rate Average rat
Slide 21: Balance Sheet & Cash Flow Highlights
BALANCE SHEET & CASH FLOW HIGHLIGHTS 21 (billion yen) FY19 end Dec 31, 2020 Total assets 2,315.2 2,296.8 Cash and cash equivalents 318.4 306.5 Total equity attributable to owners of the parent 1,289.2 1,368.6 Equity ratio (%) 55.7% 59.6% (billion yen) Q3/FY19 Q3/FY20 FY19 Cash flows from operating a
Slide 22: Capital Allocation
CAPITAL ALLOCATION 22 ⚫ 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 23: Details of Shareholder Returns
DETAILS OF SHAREHOLDER RETURNS 23 (yen) (billion yen) Dividends per Share* (left axis) Profit** (right axis) 250 2,500 40 2,000 200 30 150 1,500 42 20 40 100 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 39.3
Slide 24: Filing Opportunities Announced in Strategic Plan 2018
FILING OPPORTUNITIES 24 ANNOUNCED IN STRATEGIC PLAN 2018 As of Jan 2021 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 25: Robust Pipeline of Astellas
ROBUST PIPELINE OF ASTELLAS 25 Phase 1 Phase 2 Phase 3 Filed ASP1948/PTZ-329 zolbetuximab enzalutamide enzalutamide (Pancreatic adenocarcinoma) (M0 CSPC, M1 CSPC: China) (M1 CSPC: EU) ASP1951/PTZ-522 enfortumab vedotin gilteritinib gilteritinib (Other solid tumors) (Earlier-stage AML, Pediatric use)
Slide 26: Progress in Overall Pipeline
PROGRESS IN OVERALL PIPELINE 26 Phase 1 Entry to Approval since Q2/FY2020 Financial Results Announcement in Oct 2020 Phase 1 Entry Phase 2 Entry Phase 3 Entry Filing Approval ASP0739 tacrolimus enzalutamide Cancer Prevention of Nonmetastatic rejection after lung castration-resistant transplantation:
Slide 27: Enzalutamide: Androgen Receptor Inhibitor (1/2)
ENZALUTAMIDE: 27 ANDROGEN RECEPTOR INHIBITOR (1/2) 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) (2nd line+) Salvage in US & JP Launched Launched Acti
Slide 28: Enzalutamide (2/2): Phase 3 Study Data by Disease Stage
ENZALUTAMIDE (2/2): 28 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 29: Gilteritinib: FLT3 Inhibitor
GILTERITINIB: FLT3 INHIBITOR 29 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 Launched in US, JP, and E
Slide 30: Enfortumab Vedotin (EV): Nectin-4 Targeted ADC (1/5)
ENFORTUMAB VEDOTIN (EV) : 30 NECTIN-4 TARGETED ADC (1/5) For urothelial cancer Met the primary endpoint (OS) in Sep 2020, based mUC, Platinum and PD-1/L1 inhibitor pretreated; P3: EV-301 n=608 on the planned interim analysis (full data to be EV mono vs. Chemo presented at ASCO GU 2021) mUC, Previous
Slide 31: Enfortumab Vedotin (EV) (2/5): Overall mUC Program
ENFORTUMAB VEDOTIN (EV) (2/5): 31 OVERALL mUC PROGRAM Early stage - Disease stage of urothelial cancer - Late stage NMIBC MIBC mUC Stages 0a-1 Stages 2 and 3 Stage 4 Ta: Noninvasive papillary T2: Tumor invades muscle T4b: Tumor invades pelvic wall, carcinoma T3: Tumor invades perivesical fat abdomin
Slide 32: Enfortumab Vedotin (EV) (3/5): Clinical Studies in MIBC
ENFORTUMAB VEDOTIN (EV) (3/5): 32 CLINICAL STUDIES IN MIBC 1) Phase 3 study in cis-ineligible MIBC (KEYNOTE-905/EV-303): Perioperative EV+Pembro vs. Cystectomy alone EFS and OS span the duration of the trial ⚫ Endpoints: Pembro ✓ Primary (dual): EFS and pCR Cystectomy Arm A Pembro [14 cycles] ✓ Key
Slide 33: Enfortumab Vedotin (EV) (4/5): Phase 1b/2 EV-103 Study Design
ENFORTUMAB VEDOTIN (EV) (4/5): 33 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 1L or Cohort E metasta
Slide 34: Enfortumab Vedotin (5/5): Number of UC Patients
ENFORTUMAB VEDOTIN (5/5): 34 NUMBER OF UC PATIENTS MIBC mUC Urothelial Total All stages cancer Post- (Incident Drug treated Drug treated (Incidence) (Annual) cystectomy + Newly (1L) (2L+*) recurrent) US 79,000 20,000 19,000 15,000 8,000 EU5 118,000 32,000 29,000 27,000 12,000 JP 39,000 10,000 8,000
Slide 35: Zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody
ZOLBETUXIMAB: 35 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 36: Fezolinetant: NK3 Receptor Antagonist
FEZOLINETANT: NK3 RECEPTOR ANTAGONIST 36 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 37: AT132 (Resamirigene Bilparvovec): rAAV8-Des-hMTM1
AT132 (RESAMIRIGENE BILPARVOVEC): Genetic Regulation 37 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 38: On the Forefront of Healthcare Change
ON THE FOREFRONT OF HEALTHCARE CHANGE