Astellas Pharma Inc. · TSE:4503
Astellas Pharma — Q2 2022 Earnings Presentation
43 slides from Astellas Pharma's earnings presentation, Oct 31, 2022
Slide 1: Q2/FY2022 Financial Results
Q2/FY2022 FINANCIAL RESULTS ENDED SEPTEMBER 30, 2022 Kenji Yasukawa, Ph.D. President and CEO Astellas Pharma Inc. October 31, 2022
Slide 2: Cautionary Statement Regarding Forward-Looking Information
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING 2 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 sta
Slide 3: Agenda
AGENDA 3 Q2/FY2022 Consolidated Financial Results I FY2022 Revised Forecasts II Initiatives for Sustainable Growth
Slide 4: Q2/FY2022 Financial Results: Overview
Q2/FY2022 FINANCIAL RESULTS: OVERVIEW 4 Revenue increased 17% YoY and was on track when excluding FX impact ⚫ XTANDI: Sales in the US were below initial full-year forecast. Strong performance in Europe and Japan covered the underachieving performance in the US ⚫ Strategic products: Sales of PADCEV e
Slide 5: Q2/FY2022 Financial Results
Q2/FY2022 FINANCIAL RESULTS 5 Change FY22 (billion yen) Q2/FY21 Q2/FY22 Change Progress FX impact (%) Initial FCST Revenue 651.7 762.2 +110.5 +17.0% 1,443.0 52.8% +84.3 bil. yen +12.5 bil. yen (Incl. the impact of Cost of sales 124.7 151.7 +26.9 +21.6% elimination of unrealized profit % of revenue 1
Slide 6: Q2/FY2022 Financial Results & Outlook: XTANDI
Q2/FY2022 FINANCIAL RESULTS & OUTLOOK: XTANDI 6 Expect continued global growth despite the challenging market conditions in the US Q2/FY2022 FY2022 FY2022 (billion yen) YoY Progress Act Initial FCST Revised FCST ✓ Global sales are in line with expectations up to Q2, as strong performance in +64.4 (+
Slide 7: Q2/FY2022 Financial Results & Outlook: Strategic Products
Q2/FY2022 FINANCIAL RESULTS & OUTLOOK: STRATEGIC PRODUCTS 7 Sales growth exceeding expectations for PADCEV, especially in Japan, upward revision of FCST Q2/FY2022 FY2022 FY2022 (billion yen) YoY Progress Act Initial FCST Revised FCST ✓ Global sales exceeding expectations +11.7 (+128%) 57% 45.4 20.8
Slide 8: Q2/FY2022 Financial Results: Cost Items
Q2/FY2022 FINANCIAL RESULTS: COST ITEMS 8 Cost of sales ratio increased YoY and was above full-year forecast SG&A expenses were on track and decreased YoY when excluding FX impact R&D expenses were on track when excluding FX impact Core basis: Main items for YoY and progress against FCST Cost of sal
Slide 9: FY2022 Revised Forecast
FY2022 REVISED FORECAST 9 ⚫ Revenue: Upward revision ➢ XTANDI: Downward revision in US; Challenging market conditions to continue Q3 onwards. Upward revision in Europe and Japan ➢ Reflect positive FX impact Exchange rates for revised forecast: ⚫ Core OP: No Change 137 USD/yen,139 EUR/yen (Forecast r
Slide 10: Agenda
AGENDA 10 Q2/FY2022 Consolidated Financial Results I FY2022 Revised Forecasts II Initiatives for Sustainable Growth
Slide 11: XTANDI & Strategic Products: Key Events Expected in FY2022
XTANDI & STRATEGIC PRODUCTS: KEY EVENTS EXPECTED IN FY2022 11 Q1 Q2 Q3 Q4 EMBARK TLR 1 Target filing timeline for M0 enzalutamide / CSPC based on EMBARK XTANDI China ARCHES TLR 1 pushed to FY2023 or later EV-103 Cohort K sBLA submission (1L mUC; US) Jul TLR Oct enfortumab vedotin / EV-203 TLR (pre-t
Slide 12: Fezolinetant: Key Success Factors and Latest Status in US and Europe
FEZOLINETANT: 12 KEY SUCCESS FACTORS AND LATEST STATUS IN US AND EUROPE Steady progress of development, important to approach different Key Success Factors in each region US Europe3 Number of eligible patients1: ~10M Number of eligible patients1: ~13M Key Success Factor2 Key Success Factor2 • Women
Slide 13: Progress in Focus Area Approach (1/4): Current Status of Projects in Clinical Trial
PROGRESS IN FOCUS AREA APPROACH (1/4): 13 CURRENT STATUS OF PROJECTS IN CLINICAL TRIAL (Red: Updates since the last financial results announcement) No. of projects Primary Focus Biology/Modality/Technology 1 Project Current status aiming PoC by end FY25 2 AT132 ASPIRO study put on clinical hold by F
Slide 14: New Primary Focus “Targeted Protein Degradation” (1)
PROGRESS IN FOCUS AREA APPROACH (2/4): 14 NEW PRIMARY FOCUS “TARGETED PROTEIN DEGRADATION” (1) Primary Focus “Targeted Protein Degradation” Applicability and expandability ⚫ Utilizes the ubiquitin-proteasome system, an intrinsic proteolytic ⚫ Applicable to various targets by conversion of target pro
Slide 15: New Primary Focus “Targeted Protein Degradation” (2)
PROGRESS IN FOCUS AREA APPROACH (3/4): 15 NEW PRIMARY FOCUS “TARGETED PROTEIN DEGRADATION” (2) E3 ligase Polyubiquitination (add ubiquitin to (recognized by proteasome) Lead program ASP3082 target protein) ⚫ KRAS has been considered an undruggable target with less Ubiquitin druggable pockets, making
Slide 16: Strategic Investment with Taysha Gene Therapies
PROGRESS IN FOCUS AREA APPROACH (4/4): 16 STRATEGIC INVESTMENT WITH TAYSHA GENE THERAPIES Strategic investment with Taysha to expand gene therapy pipeline Overview of agreement TSHA-102 ⚫ Investment of $50 million in total ⚫ Target disease: Rett syndrome ➢ 15% of the outstanding common stock of Tays
Slide 17: Progress Toward Achieving CSP2021
PROGRESS TOWARD ACHIEVING CSP2021 17 Revenue, Pipeline Value Core OP XTANDI and Strategic products: 1 5 Flat SG&A in absolute terms ✓ SG&A expenses controlled in line ¥1.2T in FY2025 with full-year forecast, decreased Sufficient R&D investments ✓ XTANDI: Sales in the US were below expectations, of
Slide 18: Upcoming Event
UPCOMING EVENT 18 R&D Meeting ➢ Dec 9th 2022, 10:00-11:30 (JST) Sustainability Meeting ➢ Feb 17th 2023, 14:00-15:30 (JST)
Slide 19: Appendix
APPENDIX
Slide 20: Change Exchange Rates Used for Elimination of Unrealized Profit on Inventories
CHANGE EXCHANGE RATES USED FOR ELIMINATION OF UNREALIZED 20 PROFIT ON INVENTORIES ⚫ In consideration of recent rapid exchange rate fluctuations, it was determined we changed our consolidation process taking into account its materiality as its financial impact is no longer negligible ⚫ Changed the ex
Slide 21: Change Exchange Rates Used for Elimination of Unrealized Profit (Pro Forma Figures)
CHANGE EXCHANGE RATES USED FOR ELIMINATION OF UNREALIZED 21 PROFIT ON INVENTORIES（PRO FORMA FIGURES） ⚫ Pro forma figures when calculating the cost of sales at exchange rate after the change (average rate) is as shown in red font in the table below Quarterly Year to Date (billion yen) Change Q1/FY21
Slide 22: Q2/FY2022: Revenue by Region
Q2/FY2022: REVENUE BY REGION 22 (billion yen) Q2/FY21 Q2/FY22 Change (%) Japan 130.5 133.3 +2.1% United States 270.1 328.3 +21.5% Established Markets 157.4 180.1 +14.5% Greater China 33.1 45.0 +36.2% International Markets 55.3 63.3 +14.5% Established Markets: Europe, Canada, Australia Greater China:
Slide 23: Q2/FY2022: Sales of Main Products
Q2/FY2022: SALES OF MAIN PRODUCTS 23 FY22 (billion yen) Q2/FY21 Q2/FY22 Change CER growth Initial FCST XTANDI 267.6 332.0 +24.1% +8.5% 642.5 PADCEV 9.1 20.8 +127.8% +98.1% 36.5 XOSPATA 16.5 23.5 +42.5% +23.6% 46.2 EVRENZO 1.4 1.5 +8.7% +7.7% 9.9 mirabegron 84.4 93.4 +10.7% -2.6% 178.7 Prograf 92.3 1
Slide 24: Q2/FY2022 Actual: FX Rate
Q2/FY2022 ACTUAL: FX RATE 24 Average rate for the period Currency Q2/FY21 Q2/FY22 Change USD 110 yen 134 yen -24 yen EUR 131 yen 139 yen -8 yen Change in current rate from previous fiscal year end Currency Q2/FY21 Q2/FY22 USD -1 yen -23 yen EUR +1 yen -7 yen <Impact of exchange rate on financial res
Slide 25: FY2022 FCST: FX Rate & FX Sensitivity
FY2022 FCST： FX RATE & FX SENSITIVITY 25 Exchange rate FY2022 FY2022 Average for the period Initial FCST Revised FCST USD 120 yen 137 yen EUR 135 yen 139 yen Forecast rates from Q3 onwards: 140 USD/yen, 140 EUR/yen Estimated FX sensitivity (Q3 onwards) of FY2022 revised forecasts by 1 yen depreciati
Slide 26: Balance Sheet & Cash Flow Highlights
BALANCE SHEET & CASH FLOW HIGHLIGHTS 26 (billion yen) FY21 end FY22 Q2 end Total assets 2,332.4 2,583.7 Cash and cash equivalents 316.0 361.1 Total equity attributable to owners of the parent 1,460.3 1,649.5 Equity ratio (%) 62.6% 63.8% (billion yen) Q2/FY21 Q2/FY22 FY21 Cash flows from operating ac
Slide 27: Capital Allocation
CAPITAL ALLOCATION 27 1 Top priority is investment 2 Raise dividend level aligned 3 Flexibly execute share for business growth with profit / cashflow plan and buyback by excess cash actual performance throughout CSP2021 period Aiming for higher level of dividends increase during CSP2021 aligned with
Slide 28: Robust Pipeline of Astellas
ROBUST PIPELINE OF ASTELLAS 28 Phase 1 Phase 2 Phase 3 Submitted/Filed enfortumab vedotin enfortumab vedotin enzalutamide enfortumab vedotin (NMIBC) (Other solid tumors) (M0 CSPC, M1 CSPC: China) (mUC previously untreated, Cis-ineligible: US) gilteritinib zolbetuximab enfortumab vedotin fezolinetant
Slide 29: Progress in Overall Pipeline
PROGRESS IN OVERALL PIPELINE 29 Phase 1 Entry to Approval since the Last Financial Results Announcement Phase 1 Entry Phase 2 Entry Phase 3 Entry Filing Approval ASP2074 enfortumab vedotin Cancer Locally advanced or metastatic urothelial cancer who are ineligible to receive cisplatin-based chemother
Slide 30: XTANDI & Strategic Products: Status Update
XTANDI & STRATEGIC PRODUCTS: STATUS UPDATE 30 (Red: Updates since the last financial results announcement) Project / Product Indication Current status enzalutamide / M1 CSPC • US: Approved label update to include the OS data in Sep 2022 XTANDI • EU: CHMP positive opinion received for label update to
Slide 31: Enzalutamide (1/2): Androgen Receptor Inhibitor
ENZALUTAMIDE (1/2): ANDROGEN RECEPTOR INHIBITOR 31 (Red: Updates since the last financial results announcement) US/Europe/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 lin
Slide 32: Enzalutamide (2/2): Phase 3 Study Data by Disease Stage
ENZALUTAMIDE (2/2): PHASE 3 STUDY DATA BY DISEASE STAGE 32 Continued potential in earlier lines with consistent survival benefit and longer duration of treatment Early stage Late stage Castration-sensitive (CSPC) Castration-resistant (CRPC) Disease stage M1 M1 M0 M1 M0 (pre-chemo) (post-chemo) Phase
Slide 33: Enfortumab Vedotin (1/4): Nectin-4 Targeted ADC Overall UC Program
ENFORTUMAB VEDOTIN (EV) (1/4): NECTIN-4 TARGETED ADC 33 OVERALL UC PROGRAM (Red: Updates since the last financial results announcement) 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 inhibit
Slide 34: Enfortumab Vedotin (2/4): Clinical Studies
ENFORTUMAB VEDOTIN (EV) (2/4): 34 CLINICAL STUDIES (Red: Updates since the last financial results announcement) For urothelial cancer mUC, Platinum and PD-1/L1 inhibitor pretreated; sBLA (to convert regular approval) approved in US in Jul 2021. P3: EV-301 NCT03474107 n=608 EV mono vs. Chemo Approved
Slide 35: Enfortumab Vedotin (3/4): Study Data by Disease Stage of UC
ENFORTUMAB VEDOTIN (EV) (3/4): 35 STUDY DATA BY DISEASE STAGE OF UC (Red: Updates since the last financial results announcement) Early stage Late stage MIBC mUC Disease stage Surgery eligible Previously untreated (first line) PD-1/L1 inhibitor pretreated Cis- Cis- Platinum Platinum naïve Cis-ineligi
Slide 36: Enfortumab Vedotin (4/4): Future Outlook
ENFORTUMAB VEDOTIN (EV) (4/4): 36 FUTURE OUTLOOK ⚫ The most significant growth driver is 1L mUC indication, which is expected to account for more than half of total sales in the future ⚫ Success in NMIBC and other solid tumors will provide further growth potential Peak <Already approved / pivotal ph
Slide 37: Gilteritinib: FLT3 Inhibitor
GILTERITINIB: FLT3 INHIBITOR 37 (Red: Updates since the last financial results announcement) PASHA (HOVON) PrE0905 (PrECOG) Chemo Maintenance ADMIRAL High- consolidation intensity GOSSAMER induction Maintenance chemo Transplant Salvage therapy FLT3 mut+ MORPHO AML Launched Low-intensity chemo P1 (tr
Slide 38: Zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody
ZOLBETUXIMAB: ANTI-CLAUDIN 18.2 MONOCLONAL ANTIBODY 38 Target: Claudin 18.2 Gastric and GEJ adenocarcinoma ⚫ Claudin is a major structural component of tight junctions ⚫ Target patient population: and seals intercellular space in epithelial sheets HER2-, Claudin 18.2+ locally advanced and ⚫ Broadly
Slide 39: Fezolinetant: NK3 Receptor Antagonist
FEZOLINETANT: NK3 RECEPTOR ANTAGONIST 39 (Red: Updates since the last financial results announcement) VMS has a significant negative impact on QoL Women’s Health Initiative (WHI) Study 2 ⚫ Physical symptoms include hot flashes and night sweats, which can ⚫ Initial data analyses showed an association
Slide 40: AT132 (Resamirigene Bilparvovec): rAAV8-Des-hMTM1
AT132 (RESAMIRIGENE BILPARVOVEC): rAAV8-Des-hMTM1 40 Characteristics of AT132 X-linked myotubular myopathy (XLMTM) ⚫ Lead program in the gene therapy pipeline of Audentes ⚫ Rare neuromuscular disease with X-linked, Therapeutics, acquired by Astellas loss of function mutations in MTM1 gene in Jan 202
Slide 41: Focus Area Approach: Clinical Proof and Expansion of Key Platforms
FOCUS AREA APPROACH: 41 CLINICAL PROOF AND EXPANSION OF KEY PLATFORMS No. of projects Modality Primary Focus Biology/Modality/Technology 1 Lead project FY22 FY23 FY24-25 aiming PoC by end FY25 2 Small molecule AT132 Antibody Genetic Gene replacement (AAV) Updated timeline for PoC judgement Gene regu
Slide 42: Progress in Rx+ Program
PROGRESS IN Rx+ PROGRAM 42 <Major updates> ⚫ pudexacianinium chloride (ASP5354): Initiated Phase II study to expand indication to lymph nodes identification in lymphatic mapping performed prior to cancer resection surgery ⚫ Smartphone game application “Moomin Move”: Partnership with Hokkaido and Aom
Slide 43: On the Forefront of Healthcare Change
ON THE FOREFRONT OF HEALTHCARE CHANGE