Astellas Pharma Inc. · TSE:4503
Astellas Pharma — FY2021 Earnings Presentation
52 slides from Astellas Pharma's earnings presentation, Apr 27, 2022
Slide 1: FY2021 Financial Results Ended March 31, 2022
FY2021 FINANCIAL RESULTS ENDED MARCH 31, 2022 Kenji Yasukawa, Ph.D. President and CEO Astellas Pharma Inc. April 27, 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 I FY2021 Consolidated Financial Results II Initiatives for Sustainable Growth FY2022 Forecasts and III Key Expected Events
Slide 4: CSP2021 Major Progress in Q4 FY2021
CSP2021 MAJOR PROGRESS IN Q4FY2021 4 Performance Goals 1. Revenue: XTANDI and Strategic products sales ≥¥1.2T in FY2025 2. Pipeline value: Focus Area projects expected sales ≥¥0.5T in FY2030 3. Core operating profit margin: ≥30% in FY2025 • Obtained fezolinetant long-term safety data • SG&A control
Slide 5: FY2021 Financial Results: Overview
FY2021 FINANCIAL RESULTS: OVERVIEW 5 Record revenue increase for the first time since FY2018 Revenue increased 4% YoY and was slightly behind full-year forecast ⚫ Sales of XTANDI and Strategic products increased 19% YoY, offsetting sales decrease due to termination of sales and distribution / transf
Slide 6: FY2021 Financial Results
FY2021 FINANCIAL RESULTS 6 Change FY2021 (billion yen) FY2020 FY2021 Change Achievement FX impact (%) FCST* Revenue 1,249.5 1,296.2 +46.6 +3.7% 1,323.0 98.0% +59.6 bil. yen Cost of sales 246.1 253.0 +6.9 +2.8% % of revenue 19.7% 19.5% -0.2 ppt SG&A expenses 504.3 548.8 +44.5 +8.8% 541.0 101.4% +25.0
Slide 7: FY2021 Financial Results: Sales of Main Products
FY2021 FINANCIAL RESULTS: 7 SALES OF MAIN PRODUCTS FY2021 Actual (billion yen) ✓ Double-digit growth continues globally XTANDI YoY: +75.9 (+17%) ✓ Sales against ambitious forecast were behind due to the following factors; Achievement 534.3 against FCST: 96% US: Impact of COVID-19 (less sales promoti
Slide 8: FY2021 Financial Results: Cost Items
FY2021 FINANCIAL RESULTS: COST ITEMS 8 SG&A expenses increased YoY and were above full-year FCST R&D expenses increased YoY and were below full-year FCST when excluding one-off factors Core basis: Main items for YoY and achievement against FCST Cost of sales ✓ Decrease mainly due to changes in produ
Slide 9: Agenda
AGENDA 9 I FY2021 Consolidated Financial Results II Initiatives for Sustainable Growth FY2022 Forecasts and III Key Expected Events
Slide 10: XTANDI & Strategic Products: Highlight
XTANDI & STRATEGIC PRODUCTS: HIGHLIGHT 10 (Red: Updates since the last financial results announcement) Key Events Expected in FY2021 (announced in Apr 2021) Milestone Project / Product Indication / Clinical study Result Timing Regulatory enzalutamide / XTANDI M1 hormone-sensitive prostate cancer (EU
Slide 11: Enfortumab Vedotin (EV): First Results in MIBC
ENFORTUMAB VEDOTIN (EV): FIRST RESULTS IN MIBC 11 Obtained encouraging data supporting the ongoing Phase 3 studies in MIBC <Cohort H in EV-103 study> <Antitumor activity: comparison with cisplatin-based chemotherapy data*> Patient segment Patients with MIBC who are ineligible for 60 cisplatin-based
Slide 12: Fezolinetant: Topline Results of MOONLIGHT 1 and SKYLIGHT 4 Studies
FEZOLINETANT: 12 TOPLINE RESULTS OF MOONLIGHT 1 AND SKYLIGHT 4 STUDIES ⚫ Minimal impact of MOONLIGHT 1 study results on CSP2021 sales forecast is anticipated ⚫ SKYLIGHT 4 study results further support proceeding with regulatory filings in US & EU MOONLIGHT 1 (ref.) SKYLIGHT 1/2 SKYLIGHT 4 Study type
Slide 13: Progress in Focus Area Approach (1/2): Current Status of Clinical Programs
PROGRESS IN FOCUS AREA APPROACH (1/2): 13 CURRENT STATUS OF CLINICAL PROGRAMS (Red: Updates since the last financial results announcement) Primary Focus Biology/Modality/Technology 1 Project Current status AT132 ASPIRO study put on clinical hold by FDA in Sep 2021 Genetic Gene replacement (AAV) Phas
Slide 14: Progress in Focus Area Approach (2/2): Summary of FY2021
PROGRESS IN FOCUS AREA APPROACH (2/2): 14 SUMMARY OF FY2021 Achievement in FY2021 No. of projects aiming PoC by end FY25 Number of Terminated Phase 1 PoC PoC not As of Primary Focus Biology/Modality/Technology 1 new drug CSP2021 3 before PoC entry achieved achieved Apr 2022 candidates 2 judgement Ge
Slide 15: Progress in Rx+ Program (1/2): Summary of FY2021
PROGRESS IN Rx+ PROGRAM (1/2): SUMMARY OF FY2021 15 Key events expected in FY2021 (announced in Apr 2021) Sphere * Program Event Result Timing Chronic disease Fit-eNce Initiation of pilot marketing for ✓ Sep 2021 progression prevention at-home service (Fit-eNce Home) Game application for Initiation
Slide 16: Progress in Rx+ Program (2/2): Pudexacianinium Chloride (ASP5354)
PROGRESS IN Rx+ PROGRAM (2/2): 16 PUDEXACIANINIUM CHLORIDE (ASP5354) Pudexacianinium showed favorable efficacy and safety in Phase 2 study, which support further development Results of Phase 2 study Next steps ⚫ Pudexacianinium enhanced intraoperative ureter ⚫ Phase 3 study is planned to start in FY
Slide 17: Review of the First Year of CSP2021
REVIEW OF THE FIRST YEAR OF CSP2021 Progress in CSP2021 17 ⚫ As expected Performance Goals are achievable despite some challenges ⚫ Recognized as challenge Revenue, Pipeline Value Core OP XTANDI and Strategic products*: 1 5 Flat SG&A in absolute terms ⚫ Strategic upfront investment for future growth
Slide 18: Agenda
AGENDA 18 I FY2021 Consolidated Financial Results II Initiatives for Sustainable Growth FY2022 Forecasts and III Key Expected Events
Slide 19: FY2022 Forecast: Overview
FY2022 FORECAST: OVERVIEW 19 ⚫ Revenue and Profit to increase in FY2022 Core OP margin for FY2022 to be 20.1% ⚫ XTANDI and Strategic products continue to grow (+24%, YoY) Growth to more than offset the decrease of mature products ⚫ Resource allocation to key strategic areas such as R&D investment fo
Slide 20: FY2022 Forecast
FY2022 FORECAST 20 FY2021 FY2022 FY2022 FCST (FX rate) (billion yen) Change (%) USD: 120 yen actual forecast EUR: 135 yen Revenue 1,296.2 1,443.0 +11.3% SG&A expenses 548.8 598.0 +9.0% US XTANDI co-pro fee 139.3 182.0 +30.6% SG&A excl. the above 409.5 416.0 +1.6% R&D expenses 246.0 254.0 +3.2% Core
Slide 21: FY2022 Forecast: XTANDI and Strategic Products
FY2022 FORECAST: 21 XTANDI AND STRATEGIC PRODUCTS FY2022 Forecast FY2022 initiatives and growth factors XTANDI 642.5 billion yen • Expand sales in M1 CSPC in US, Japan and International Markets • Continue strong growth in M1 CRPC in China +108.2, YoY (+20%) XOSPATA 46.2 billion yen • Expect continue
Slide 22: XTANDI & Strategic Products: Key Events Expected in FY2022
XTANDI & STRATEGIC PRODUCTS: KEY EVENTS EXPECTED IN FY2022 22 Q1 Q2 Q3 Q4 Regulatory EMBARK TLR 1 submission enzalutamide / Filing (M0 CSPC; US) XTANDI Data readout China ARCHES TLR 1 Others EV-103 Cohort K TLR 1 enfortumab Filing (1L mUC; US) vedotin / PADCEV EV-203 TLR (pre-treated mUC; China) 1 E
Slide 23: Potential Peak Sales: XTANDI and Strategic Products (Update)
POTENTIAL PEAK SALES: XTANDI AND STRATEGIC PRODUCTS (UPDATE) 23 Assumptions reviewed for each product, expect continued strong growth Downward revision of potential peak sales for AT132, reflecting the latest situation Potential Peak Sales Product Assumptions Update (Global, billions of yen) XTANDI
Slide 24: Focus Area Approach: Clinical Proof and Expansion of Key Platforms
FOCUS AREA APPROACH: 24 CLINICAL PROOF AND EXPANSION OF KEY PLATFORMS Expecting PoC judgement in 2 projects, Phase 1 entry in 5 projects (lead and follow-on projects) No. of projects Primary Focus Biology/Modality/Technology 1 Lead project FY22 FY23 FY24-25 aiming PoC Modality by end FY25 2 Small mo
Slide 25: Rx+ Program: Key Events Expected in FY2022
Rx+ PROGRAM: KEY EVENTS EXPECTED IN FY2022 25 Category Program Event Digital health EG Holter Initiation of pilot marketing Other services Digital therapeutics BlueStar Initiation of clinical study (Japan) Drug-device pudexacianinium chloride FSFT in Phase 3 study combination (ASP5354) ⚫ Implantable
Slide 26: Conclusion: Toward Mid- to Long-Term Growth Trend
CONCLUSION: TOWARD MID- TO LONG-TERM GROWTH TREND 26 Product portfolio has changed and sales of XTANDI and Strategic products growing significantly Record revenue increase in FY2021 for the first time since FY2018 Continued growth in FY2022 and aiming to achieve rich development milestones Key devel
Slide 27: Appendix
APPENDIX
Slide 28: "Dansharism" Movement
“DANSHARISM” MOVEMENT 28 ⚫ Perfectly fitting for a Japanese company, expanding the concept of “Danshari,” which is the thoroughly elimination of waste, globally and into daily operations ⚫ At the same time, ensuring that managers have financial discipline and cost ownership, and transforming into an
Slide 29: FY2021 Financial Results: Revenue
FY2021 FINANCIAL RESULTS: REVENUE 29 Revenue increase driven by growth of XTANDI and Strategic products, which offset sales decrease due to termination of sales and distribution / transfer of products FY2020 FY2021 Change Change (%) Revenue 1,249.5 bil. yen 1,296.2 bil. yen +46.6 bil. yen +3.7% Incr
Slide 30: FY2021: Revenue by Region
FY2021: REVENUE BY REGION 30 (billion yen) FY2020 FY2021 Change (%) Japan 279.1 258.8 -7.3% United States 473.2 537.5 +13.6% Established Markets 293.2 315.2 +7.5% Greater China 59.3 66.3 +11.8% International Markets 111.1 110.1 -0.9% Established Markets: Europe, Canada, Australia Greater China: Chin
Slide 31: FY2021: Sales of Main Products
FY2021: SALES OF MAIN PRODUCTS 31 FY21 (billion yen) FY2020 FY2021 Change CER growth FCST* XTANDI 458.4 534.3 +16.6% +10.6% 554.1 XOSPATA 23.8 34.1 +42.9% +35.6% 35.4 PADCEV 12.8 21.7 +69.5% +60.8% 20.7 EVRENZO 1.1 2.6 +131.5% +131.0% 7.2 mirabegron 163.6 172.3 +5.3% +0.7% 176.3 Prograf 182.7 185.4
Slide 32: FY2021 Financial Results: Business Update for Main Products
FY2021 FINANCIAL RESULTS: 32 BUSINESS UPDATE FOR MAIN PRODUCTS Global sales increased +17% given the ongoing focus on recent M1 HSPC launches, but did not achieve the ambitious forecast. In the US, demand grew in excess of 10% YoY, but sales growth has been below expectations due to the impact XTAND
Slide 33: FY2021 Actual: FX Rate
FY2021 ACTUAL: FX RATE 33 Average rate for the period Currency FY2020 FY2021 Change USD 106 yen 112 yen +6 yen EUR 124 yen 131 yen +7 yen Change in closing rate from previous fiscal year end Currency FY2020 FY2021 USD +2 yen +11 yen EUR +10 yen +5 yen <Impact of exchange rate on financial results> ⚫
Slide 34: FY2022 FCST: FX Rate & FX Sensitivity
FY2022 FCST： FX RATE & FX SENSITIVITY 34 Average rate for the period Currency FY2021 FY2022 FCST change USD 112 yen 120 yen +8 yen EUR 131 yen 135 yen +4 yen Change in closing rate from the previous FY end Currency FY2021 FY2022 FCST USD +11 yen -2 yen EUR +5 yen +0 yen Estimated FX sensitivity of F
Slide 35: Balance Sheet & Cash Flow Highlights
BALANCE SHEET & CASH FLOW HIGHLIGHTS 35 (billion yen) FY2020 end FY2021 end Total assets 2,273.6 2,332.4 Cash and cash equivalents 326.1 316.0 Total equity attributable to owners of the parent 1,386.1 1,460.3 Equity ratio (%) 61.0% 62.6% (billion yen) FY2020 FY2021 Cash flows from operating activiti
Slide 36: Capital Allocation
CAPITAL ALLOCATION 36 1 Top priority is investment 2 Raise dividend level aligned 3 Flexibly execute share Acquisition of own shares announced in Feb. 2022 for business growth with profit / cashflow plan and buyback by excess cash ◼ From Feb. 3 to Mar. 9, 2022 actual performance ◼ 26 million shares
Slide 37: Progress in Focus Area Approach: New Clinical Programs
PROGRESS IN FOCUS AREA APPROACH: 37 NEW CLINICAL PROGRAMS First-in-class programs from Focus Area approach entered clinical phase ASP1570 (PF Immuno-Oncology) ASP8731 (PF Mitochondria Biology) ⚫ Small molecule DGKζ inhibitor ⚫ Small molecule BACH1 inhibitor ⚫ Target disease: Cancer ⚫ Target disease:
Slide 38: Robust Pipeline of Astellas
ROBUST PIPELINE OF ASTELLAS 38 Phase 1 Phase 2 Phase 3 enfortumab vedotin enfortumab vedotin enzalutamide (NMIBC) (Other solid tumors) (M0 CSPC, M1 CSPC: China) gilteritinib zolbetuximab gilteritinib (Newly diagnosed AML, HIC-ineligible) (Pancreatic adenocarcinoma) (Earlier-stage AML, pediatric use)
Slide 39: Progress in Overall Pipeline
PROGRESS IN OVERALL PIPELINE 39 Phase 1 Entry to Approval since the Last Financial Results Announcement Phase 1 Entry Phase 2 Entry Phase 3 Entry Filing Approval ASP8731 enfortumab Sickle cell disease vedotin Locally advanced or ASP3082 metastatic urothelial Cancer cancer who have previously receive
Slide 40: XTANDI & Strategic Products: Status Update
XTANDI & STRATEGIC PRODUCTS: STATUS UPDATE 40 (Red: Updates since the last financial results announcement) Project / Product Indication Current status enzalutamide / M1 CSPC • US: Filed label update to include the OS data in Dec 2021 XTANDI • EU: CHMP positive opinion received for label update to in
Slide 41: XTANDI & Strategic Products: Regulatory Timeline (Update)
XTANDI & STRATEGIC PRODUCTS: REGULATORY TIMELINE (UPDATE) 41 Expand additional indications for XTANDI, XOSPATA and PADCEV Expect new launch for zolbetuximab, fezolinetant Target Filing Timing Product FY2021 FY2022 FY2023 FY2024 FY2025 or later XTANDI M0 CSPC (enzalutamide) XOSPATA AML, post-HSCT AML
Slide 42: Enzalutamide (1/2): Androgen Receptor Inhibitor
ENZALUTAMIDE (1/2): ANDROGEN RECEPTOR INHIBITOR 42 (Red: Updates since the last financial results announcement) 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) (
Slide 43: Enzalutamide (2/2): Phase 3 Study Data by Disease Stage
ENZALUTAMIDE (2/2): PHASE 3 STUDY DATA BY DISEASE STAGE 43 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 44: Gilteritinib: FLT3 Inhibitor
GILTERITINIB: FLT3 INHIBITOR 44 (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 45: Enfortumab Vedotin (1/4): Nectin-4 Targeted ADC Overall UC Program
ENFORTUMAB VEDOTIN (EV) (1/4): NECTIN-4 TARGETED ADC 45 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 46: Enfortumab Vedotin (2/4): Clinical Studies
ENFORTUMAB VEDOTIN (EV) (2/4): 46 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 n=608 EV mono vs. Chemo Approved in JP in Se
Slide 47: Enfortumab Vedotin (3/4): Study Data by Disease Stage of UC
ENFORTUMAB VEDOTIN (EV) (3/4): 47 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 48: Enfortumab Vedotin (4/4): Future Outlook
ENFORTUMAB VEDOTIN (EV) (4/4): 48 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 <Already approved / pivotal phase>
Slide 49: Zolbetuximab: Anti-Claudin 18.2 Monoclonal Antibody
ZOLBETUXIMAB: ANTI-CLAUDIN 18.2 MONOCLONAL ANTIBODY 49 (Red: Updates since the last financial results announcement) 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 epithel
Slide 50: Fezolinetant: NK3 Receptor Antagonist
FEZOLINETANT: NK3 RECEPTOR ANTAGONIST 50 (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 51: AT132 (Resamirigene Bilparvovec): rAAV8-Des-hMTM1
AT132 (RESAMIRIGENE BILPARVOVEC): rAAV8-Des-hMTM1 51 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 52: On the Forefront of Healthcare Change
ON THE FOREFRONT OF HEALTHCARE CHANGE