Astellas Pharma Inc. · TSE:4503
Astellas Pharma — Q1 2021 Earnings Presentation
41 slides from Astellas Pharma's earnings presentation, Jul 30, 2021
Slide 1: Q1/FY2021 Financial Results Ended June 30, 2021
Q1/FY2021 FINANCIAL RESULTS ENDED JUNE 30, 2021 Naoki Okamura Executive Vice President, Chief Strategy Officer and Chief Financial Officer Astellas Pharma Inc. July 30, 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 Q1/FY2021 Consolidated Financial Results I FY2021 Revised Forecasts II Initiatives for Sustainable Growth
Slide 4: Q1/FY2021 Financial Results
Q1/FY2021 FINANCIAL RESULTS 4 Change FY21 (billion yen) Q1/FY20 Q1/FY21 Change Progress FX impact (%) FCST Revenue 307.0 326.1 +19.2 +6.2% 1,323.0 24.7% +13.6 bil. yen Cost of sales 59.7 62.2 +2.6 +4.3% % of revenue 19.4% 19.1% -0.4 ppt SG&A expenses 120.8 137.1 +16.3 +13.5% 541.0 25.3% US XTANDI co
Slide 5: Q1/FY2021 Financial Results: Overview
Q1/FY2021 FINANCIAL RESULTS: OVERVIEW 5 Revenue increased, Core OP was the same level as previous fiscal year and in line with assumptions of full-year forecast ⚫ Sales of XTANDI and Strategic products* increased as expected, offsetting sales decrease due to the transfer of mature products ⚫ SG&A sp
Slide 6: Q1/FY2021 Financial Results: Revenue
Q1/FY2021 FINANCIAL RESULTS: REVENUE 6 Revenue increase driven by growth of XTANDI and Strategic products*, which offsets the sales decrease from transfer of mature products, along with temporary positive factors due to FX and reversal of COVID-19 impact in previous fiscal year Q1/FY20 Q1/FY21 Chang
Slide 7: Q1/FY2021 Financial Results: Sales of Main Products
Q1/FY2021 FINANCIAL RESULTS: 7 SALES OF MAIN PRODUCTS Q1/FY2021 actual (billion yen) ✓ Global sales increased and in line with forecast, driven by growth mainly in US and EU XTANDI YoY: +21.0 (+19%) ✓ Approved additional indication (M1 CSPC) in EU Progress 132.9 against FCST: 24% ✓ and recommended b
Slide 8: Q1/FY2021 Financial Results: Cost Items
Q1/FY2021 FINANCIAL RESULTS: COST ITEMS 8 SG&A spending is slightly ahead of full-year FCST but within controllable range for the full year. R&D expenses are on track Core basis: Main items for YoY and progress against FCST Cost of sales % of revenue ✓ Decrease mainly due to changes in product mix Y
Slide 9: FY2021 Revised Forecast
FY2021 REVISED FORECAST 9 ⚫ No changes have been made to Core basis FY2021 forecast ⚫ Downward revision of Full basis profit ✓ Booked Impairment losses on intangible assets in Q1/FY2021 due to termination of development projects (ASP0892: 21.5 bil. yen, bleselumab: 4.1 bil. yen) ✓ Severance expenses
Slide 10: Agenda
AGENDA 10 Q1/FY2021 Consolidated Financial Results I FY2021 Revised Forecasts II Initiatives for Sustainable Growth
Slide 11: XTANDI & Strategic Products: Highlight
XTANDI & STRATEGIC PRODUCTS*: HIGHLIGHT 11 * XOSPATA, PADCEV, zolbetuximab, Evrenzo, fezolinetant, AT132 Key Events Expected in FY2021 Milestone Project Indication / Clinical study Achieved Regulatory enzalutamide /XTANDI M1 hormone-sensitive prostate cancer (EU) Apr 2021 decision enfortumab vedotin
Slide 12: Enfortumab Vedotin (1/2): Overall UC Program
ENFORTUMAB VEDOTIN (EV) (1/2): 12 OVERALL UC PROGRAM sBLAs for mUC approved in US, based on the robust clinical study data 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-eligibl
Slide 13: Enfortumab Vedotin (2/2): NMIBC Landscape and Development Program
ENFORTUMAB VEDOTIN (EV) (2/2): 13 NMIBC - LANDSCAPE AND DEVELOPMENT PROGRAM To explore the activity of intravesical EV in earlier-stage UC NMIBC Stages 0a-1 Tis: Carcinoma in situ Ta: Noninvasive papillary carcinoma T1: Tumor invades lamina propia ~70% ~30% BCG- BCG- responsive unresponsive Current
Slide 14: Fezolinetant: Development Progress
FEZOLINETANT: DEVELOPMENT PROGRESS 14 Obtained 52-week data of SKYLIGHT 2 study Clinical development locally in Japan under preparation US and EU Japan ⚫ Phase 3 SKYLIGHT 2 study (pivotal): ⚫ Phase 2b dose-finding study in Japanese ✓ Obtained 52-week data in Jul 2021, patients under preparation to s
Slide 15: Progress in Focus Area Approach (1/3): Clinical Proof and Expansion of Key Platforms
From CSP2021 in May 2021 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 Primary Focus Biology/Modality/Technology 1 FY21 FY22-23 FY24-25 aiming PoC by end FY2
Slide 16: Progress in Focus Area Approach (2/3): Current Status in Primary Focus
PROGRESS IN FOCUS AREA APPROACH (2/3): 16 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 17: Progress in Focus Area Approach (3/3): Mitochondria Biology
PROGRESS IN FOCUS AREA APPROACH (3/3): 17 MITOCHONDRIA BIOLOGY Strategic collaboration for mitochondrial cell therapy (Mitochondrial transfer*) program with Minovia Therapeutics, leading company in this field * Mechanism to transfer healthy mitochondria from donor cells to diseased cells MAT platfor
Slide 18: ASP3772 as Pneumococcal Vaccine
ASP3772 AS PNEUMOCOCCAL VACCINE 18 Obtained positive Phase 2 study data in adults ASP3772 profiles Phase 2 study in elderly subjects ⚫ ASP3772 is a 24-valent vaccine for prevention of ⚫ Phase 2 study in adults aged 65-85 years show: pneumococcal disease, utilizing Affinivax’ ✓ ASP3772 is well tolera
Slide 19: Progress in Rx+ Program
PROGRESS IN Rx+ PROGRAM 19 Key events expected in FY2021 (announced in Apr 2021) Sphere * Program Event Achieved Chronic disease Fit-eNce Initiation of pilot marketing for progression at-home service prevention Game application for Initiation of pilot marketing exercise support BlueStar Initiation o
Slide 20: Sustainability: Climate Change Measures
SUSTAINABILITY: 20 CLIMATE CHANGE MEASURES Reduction of GHG emissions is moving forward as the Environmental Action Plan progresses Environmental Action Plan (climate change mitigation measures) (SBT approved) ⚫ Reduce GHG emissions (Scope 1 + 2) by 30% by FY2030 (Base year: FY2015) ⚫ Reduce GHG emi
Slide 21: Progress Toward Achieving CSP2021
PROGRESS TOWARD ACHIEVING CSP2021 21 Revenue, Pipeline Value Core OP XTANDI and Strategic products*: 1 5 Flat SG&A in absolute terms ✓ Initiatives to drive efficiency ¥1.2T in FY2025 & excellence ✓ Steady sales growth Sufficient R&D investments 6 Core OP margin of 30% in FY2025 (Astellas online
Slide 22: Appendix
APPENDIX
Slide 23: Q1/FY2021: Revenue by Region
Q1/FY2021: REVENUE BY REGION 23 (billion yen) Q1/FY20 Q1/FY21 Change (%) Japan 77.8 67.5 -13.2% United States 117.2 133.6 +14.1% Established Markets 64.0 78.0 +21.8% Greater China 14.2 16.4 +15.5% International Markets 30.2 27.8 -8.1% Established Markets: Europe, Canada, Australia Greater China: Chi
Slide 24: Q1/FY2021: Sales of Main Products
Q1/FY2021: SALES OF MAIN PRODUCTS 24 FY21 (billion yen) Q1/FY20 Q1/FY21 Change CER growth FCST XTANDI 112.0 132.9 +18.7% +13.3% 557.2 XOSPATA 5.6 8.3 +47.7% +41.7% 36.7 PADCEV 3.0 4.2 +41.9% +39.5% 20.1 Evrenzo 0.2 0.6 +282.9% - 8.6 mirabegron 40.4 44.0 +8.8% +5.4% 175.2 Prograf 45.3 45.2 -0.3% -6.7
Slide 25: Q1/FY2021 Financial Results: Business Update for Main Products
Q1/FY2021 FINANCIAL RESULTS: 25 BUSINESS UPDATE FOR MAIN PRODUCTS Global sales are in line with forecast and continued growth is expected. In US, demand grew in excess of 10% YoY. In EU, additional indication (M1 CSPC) approved in Apr 2021 and XTANDI XTANDI recommended by NICE in UK for M1 CSPC indi
Slide 26: Q1/FY2021 Actual: FX Rate
Q1/FY2021 ACTUAL: FX RATE 26 Average rate for the period Currency Q1/FY20 Q1/FY21 Change USD 108 yen 109 yen +2 yen EUR 118 yen 132 yen +13 yen Change in closing rate from previous fiscal year end Currency Q1/FY20 Q1/FY21 USD -1 yen -0 yen EUR +2 yen +2 yen <Impact of exchange rate on financial resu
Slide 27: FY2021 FCST: FX Rate & FX Sensitivity
FY2021 FCST： FX RATE & FX SENSITIVITY 27 Average rate for the period Currency FY2020 FY2021 FCST change USD 106 yen 110 yen +4 yen EUR 124 yen 130 yen +6 yen Change in closing rate from the previous FY end Currency FY2020 FY2021 FCST USD +2 yen -1 yen EUR +10 yen +0 yen Estimated FX sensitivity of F
Slide 28: Balance Sheet & Cash Flow Highlights
BALANCE SHEET & CASH FLOW HIGHLIGHTS 28 (billion yen) FY20 end Jun 30, 2021 Total assets 2,273.6 2,249.5 Cash and cash equivalents 326.1 301.9 Total equity attributable to owners of the parent 1,386.1 1,382.9 Equity ratio (%) 61.0% 61.5% (billion yen) Q1/FY20 Q1/FY21 FY20 Cash flows from operating a
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, JP) ASP1948 zolbetuximab gilteritinib roxadustat (Pancreatic adenocarcinoma) (Earlier-stage
Slide 31: Progress in Overall Pipeline
PROGRESS IN OVERALL PIPELINE 31 Phase 1 Entry to Approval since FY2020 Financial Results Announcement in Apr 2021 Phase 1 Entry Phase 2 Entry Phase 3 Entry Filing Approval enfortumab vedotin enzalutamide Non-muscle-invasive Metastatic hormone-sensitive bladder cancer prostate cancer: EU ASP1570 Canc
Slide 32: XTANDI & Strategic Products: Status Update
XTANDI & STRATEGIC PRODUCTS*: STATUS UPDATE 32 (Underlined: Updates since FY2020 Financial Results Announcement in Apr 2021) * XOSPATA, PADCEV, zolbetuximab, Evrenzo, fezolinetant, AT132 Indication Current status enzalutamide / M1 CSPC • EU: Approved in Apr 2021 XTANDI • China: Phase 3 study ongoing
Slide 33: Enzalutamide: Androgen Receptor Inhibitor (1/2)
ENZALUTAMIDE: 33 ANDROGEN RECEPTOR INHIBITOR (1/2) 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 Discontinued LACEWING due to the futility Relapsed or refractory Mo
Slide 36: Enfortumab Vedotin (1/2): Clinical Studies
ENFORTUMAB VEDOTIN (EV): NECTIN-4 TARGETED ADC (1/2) 36 CLINICAL STUDIES For urothelial cancer mUC, Platinum and PD-1/L1 inhibitor pretreated; sBLA (to convert regular approval) approved in US in P3: EV-301 n=608 EV mono vs. Chemo Jul 2021. Filed in EU and JP in Mar 2021 mUC, Previously untreated, P
Slide 37: Enfortumab Vedotin (2/2): Study Data by Disease Stage of UC
ENFORTUMAB VEDOTIN (EV) (2/2): 37 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 38: Zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody
ZOLBETUXIMAB: 38 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 39: Fezolinetant: NK3 Receptor Antagonist
FEZOLINETANT: NK3 RECEPTOR ANTAGONIST 39 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 40: AT132 (Resamirigene Bilparvovec): rAAV8-Des-hMTM1
AT132 (RESAMIRIGENE BILPARVOVEC): 40 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 41: On the Forefront of Healthcare Change
ON THE FOREFRONT OF HEALTHCARE CHANGE