アステラス製薬（4503） – Presentation Material for Information Meeting (FY2021)

FY2021 FINANCIAL RESULTSENDED MARCH 31, 2022Kenji Yasukawa, Ph.D.President and CEOAstellas Pharma Inc.April 27, 2022CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION2In 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 AstellasPharma. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties.Information about pharmaceutical products (including products currently in development) which is included in this material is not intended to constitute an advertisement or medical advice. Information about investigational compounds in development does not imply established safety or efficacy of the compounds; there is no guarantee investigational compounds will receive regulatory approval or become commercially available for the uses being investigated.AGENDA3IFY2021 Consolidated Financial ResultsIIInitiatives for Sustainable GrowthIIIFY2022 Forecasts and Key Expected EventsCSP2021 MAJOR PROGRESS IN Q4FY20214Performance Goals1. Revenue: XTANDI and Strategic products sales ≥¥1.2T in FY20252. Pipeline value: Focus Area projects expected sales ≥¥0.5T in FY20303. Core operating profit margin: ≥30% in FY2025• Obtained fezolinetant long-term safety data• PADCEV approval in EU• AT132 revision of the development plan• ASP8731 and ASP3082 advanced to clinical stage• Updated Materiality Matrix• Conducted 1st Sustainability Meeting• SG&A control• Reorganization of commercial functions in order to centralize and standardize functions globally and build stronger capabilities•Introduction of shared objectives and ambitious objectives to divisional objective setting• Established “Astellas Leadership Expectations” and training commenced for all leaders (~3,000)Strategic Goals1. Enable patients to achieve better outcomes2. Translate innovative science into proven VALUE3. Advance the Rx+ Business4. Deepen engagement in sustainabilityProgressChallengesOrganizational Health Goals1. Brave ideas pursue ambitious outcomes2. Talent and leadership thrives3. Excel as one AstellasFY2021 FINANCIAL RESULTS: OVERVIEW5Record revenue increase for the first time since FY2018Revenue 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 / transfer of product, but were behind ambitious full-year forecast aligned to CSP2021 SG&A expenses were above full-year forecast R&D expenses were on track, but below full-year forecast when excluding one-off factorsOperating profit Core OP was behind full-year forecast due to promotion of standardization / rationalization investment for the future, temporary slowdown of XTANDI sales in Q4, and cost of sales increase due to rapid yen depreciation at end of FY2021 Full basis was also behind full-year forecast Booked impairment losses on intangible assets and goodwill in Q4/FY2021 not included in full-year forecast :Review of AT132 development plan (31.2 billion yen), termination of development for ASP2390 (11.3 billion yen), and termination of development for ASP1951 (5.2 billion yen)Strategic products: XOSPATA, PADCEV, EVRENZOCSP2021: Corporate Strategic Plan 2021FY2021 FINANCIAL RESULTS6FY2020FY2021ChangeAchievementFX impactChange(%)FY2021 FCST*1,249.51,296.21,323.098.0%+59.6 bil. yen(billion yen)RevenueCost of sales% of revenueSG&A expensesUS XTANDI co-pro feeSG&A excl. the aboveR&D expensesAmortisation of intangible assetsGain on divestiture ofintangible assetsOther incomeOther expenseOperating profitProfit before taxProfit246.119.7%504.3120.2384.2224.523.8-7.6123.0136.1145.3120.6253.019.5%548.8139.3409.5246.028.324.215.3104.3155.7156.9124.1+4.5+19.0%+46.6+6.9-0.2 ppt+44.5+19.1+25.4+21.5+24.2-6.6+7.6-18.6+19.6+11.6+3.5+3.7%+2.8%+8.8%+15.9%+6.6%+9.6%—+14.4%+8.0%+2.9%541.0101.4%+25.0 bil. yen+17.2 bil. yen242.0101.7%+8.0 bil. yen218.0216.0174.071.4%72.6%71.3%* Announced in Oct 2021Core operating profit251.4244.7-2.6%270.090.6%+18.5 bil. yen7FY2021 FINANCIAL RESULTS: SALES OF MAIN PRODUCTSFY2021 Actual (billion yen)XTANDI534.3XOSPATAPADCEVEVRENZO34.121.72.6mirabegron172.3YoY: +75.9 (+17%)Achievement against FCST: 96%FY2021 FCST: 554.1YoY: +10.2 (+43%)Achievementagainst FCST: 96%FY2021 FCST: 35.4YoY: +8.9 (+70%)Achievementagainst FCST: 105%FY2021 FCST: 20.7YoY: +1.5 (+132%)Achievement against FCST: 36%FY2021 FCST: 7.2YoY: +8.7 (+5%)Achievement against FCST: 98%FY2021 FCST: 176.3 Double-digit growth continues globally Sales against ambitious forecast were behind due to the following factors;US: Impact of COVID-19 (less sales promotion activities/ slowdown of new patient starts) and increased impact from competition EU: Reimbursement delay, increased pricing pressure and competition Global sales increased driven by growth mainly in US, EU and China Captured high market share in US and Japan within the current indication Sales against full-year forecast were behind Global sales exceeded full-year forecast Revenue in US grew steadily and in line with forecast Launched in Japan in Nov. 2021 and initial uptake has been very strong and exceeded expected market penetration Sales in Japan were behind forecast due to increased competitive pressure Launched in EU from Sep. 2021 and sales were behind forecast due to the impact of COVID-19 (restriction of sales promotion activities) and the low penetration of differentiation from standard of care Global sales increased, but were behind full-year forecast In the US, sales were behind forecast due to lower than expected US OAB market growth and increased pricing pressurePADCEV (US): Co-promotion revenue from Seagen, mirabegron (Product name: Betanis/Myrbetriq/BETMIGA), OAB: Overactive bladderFY2021 FINANCIAL RESULTS: COST ITEMS8SG&A expenses increased YoY and were above full-year FCSTR&D expenses increased YoY and were below full-year FCST when excluding one-off factorsCore basis: Main items for YoY and achievement against FCST Decrease mainly due to changes in product mix FX impact on elimination of unrealized gain: +0.2 ppt SG&A excl. XTANDI US co-pro fee: +8.2 bil. yen (YoY +2.1%) (excl. FX impact) Investment in Digital Transformation (Approx. +8.0 bil. yen) Increase in sales promotion expenses for new product launch readiness (Approx. +5.0 bil. yen) Global optimization of personnel aligned with transformation of product portfolio (Approx. -9.0 bil. yen) FX impact (+8.0 bil. Yen) Increase in development cost of zolbetuximab and expanded investment in iota Inventories related to commercial production of development projects booked as R&D expenses (Approx.+8.0 bil. yen) Underspend against full-year forecast when excluding one-off factorsCost of sales% of revenueYoY: -0.2pptSG&A expensesYoY: +8.8%Achievement against FCST: 101%R&D expensesYoY: +9.6%Achievementagainst FCST: 102%CSP: Corporate Strategic PlanAGENDA9IFY2021 Consolidated Financial ResultsIIInitiatives for Sustainable GrowthIIIFY2022 Forecasts and Key Expected EventsXTANDI & STRATEGIC PRODUCTS: HIGHLIGHT(Red: Updates since the last financial results announcement)10Key Events Expected in FY2021 (announced in Apr 2021)MilestoneProject / ProductIndication / Clinical studyResultTimingenzalutamide / XTANDI M1 hormone-sensitive prostate cancer (EU)Regulatorydecisionenfortumab vedotin /PADCEVmUC, platinum and PD-1/L1 inhibitor pretreated (US a,b)mUC, cis-ineligible and who have previously received one or more therapy (US a) mUC, platinum and PD-1/L1 inhibitor pretreated (EU) Radically unresectable UC that has progressed after anti-cancer chemotherapy (JP c)roxadustat / EVRENZO Symptomatic anemia associated with CKD (EU)gilteritinib / XOSPATAR/R AML (China d)Regulatory submissionData readouta: Priority Review granted, Real-Time Oncology Review pilot program and Project Orbis appliedb: sBLA to convert Accelerated Approval to regular approvalc: Priority Review grantedd: sNDA to convert conditional approval to full approvalApr 2021Jul 2021Jul 2021Apr 2022Sep 2021Aug 2021Not achieved(: Achieved)fezolinetant52-week safety results from Phase 3 SKYLIGHT 1, 2 & 4studiesJul 2021 (SKYLIGHT 2)Oct 2021 (SKYLIGHT 1)Mar 2022 (SKYLIGHT 4)Strategic products: XOSPATA, PADCEV, zolbetuximab, EVRENZO, fezolinetant, AT132 M1: Metastatic, (m)UC: (metastatic) Urothelial cancer, CKD: Chronic kidney disease, R/R: Relapsed or refractory, AML: Acute myeloid leukemia, sBLA: Supplemental Biologics License Application, sNDA: Supplemental New Drug ApplicationENFORTUMAB VEDOTIN (EV): FIRST RESULTS IN MIBC11Obtained encouraging data supporting the ongoing Phase 3 studies in MIBCEV GC MVAC50.0%36.4%Patient segmentStudy designPatients with MIBC who are ineligible for cisplatin-based chemotherapyNeoadjuvant monotherapy3 cycles, on days 1 & 8 of 21-day cycleEnrolled participants22Primary endpointpCR rate by central pathology reviewSecondary endpointpDS rate by central pathology review, safety, etc.Neoadjuvant EV monotherapyRadical cystectomy & pelvic lymph node dissection4 to 12 weeks after last dose of neoadjuvant EVmicroscopic examination6050403020100pCR %pDS %EV: EV-103 Cohort H, cisplatin-ineligible MIBC patientsGC, MVAC: cisplatin-eligible MIBC patientsMIBC: Muscle-invasive bladder cancer, pCR: Pathological complete response, pDS: Pathologic downstaging, GC: Gemcitabine and cisplatin/carboplatin, MVAC: Methotrexate, vinblastine, doxorubicin, and cisplatin* Oncologist 21:708 (2016)FEZOLINETANT: 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 & EU12MOONLIGHT 1(ref.) SKYLIGHT 1/2SKYLIGHT 4Study typeNon-IND studyIND studyIND studyPatient segment Women with moderate to severe VMS associated with menopauseWomen with moderate to severe VMS associated with menopauseWomen with VMS associated with menopause Study design• First 12 weeks: DB, 30 mg vs. placebo (1:1)• Last 12 weeks: • First 12 weeks: • Last 40 weeks: DB, 30 mg and 45 mg vs. placebo (1:1:1)DB, 30 mg and 45 mg vs. placebo (1:1:1)• 52 weeks: active extension treatment, 30 mgactive extension treatment, 30 mg or 45 mgStudy regionChina, Korea and Taiwan US, Canada and EuropeUS, Canada and Europe527 / 5011,831• Mean change in the frequency and severity of moderate to severe VMS from baseline to week 4 & 12• Mean change in the frequency and severity of moderate to severe VMS from baseline to week 4 &12• Frequency and severity of adverse events• Percentage of participants with endometrial hyperplasia and/or endometrial cancerTopline result• Primary endpoints: Not met Numerical improvements from baseline observed but statistical significance not met• 12-week safety data: aligned with what was previously observed• Primary endpoints: Met• 12-week safety data: No new safety signal • Primary endpoint (endometrial health): Met• The most common TEAE: consistent with of concernplacebo Red: difference between MOONLIGHT 1 and SKYLIGHT 1/2 studies (up to 12 weeks) May 2022: 12-week data of SKYLIGHT 1 study at ACOGJun 2022: 52-week data of SKYLIGHT 2 study at ENDOIND: Investigational New Drug, VMS: Vasomotor symptoms, DB: Double-blind, TEAE: treatment-emergent adverse events, ACOG: American College of Obstetricians and Gynecologists, ENDO: Endocrine SocietyEnrolled participants302Primary endpointPROGRESS IN FOCUS AREA APPROACH (1/2): CURRENT STATUS OF CLINICAL PROGRAMS(Red: Updates since the last financial results announcement)Primary FocusBiology/Modality/Technology 1ProjectCurrent statusGenetic RegulationGene replacement (AAV)Gene regulation (AAV)CheckpointImmuno-OncologyArtificial adjuvant vector cell (aAVC)Oncolytic virus (intratumoral)Oncolytic virus (systemic)Bispecific immune cell engagerCancer cell therapy (UDC)Blindness & RegenerationCell replacementCell replacement (UDC)Gene regulation (AAV)AT132AT845ASP1951ASP1570ASP7517ASP0739ASP9801ASPIRO study put on clinical hold by FDA in Sep 2021Phase 1 study ongoingInterim data presented at WORLDSymposium in Feb 2022TerminatedPhase 1 study ongoingPhase 2 study in R/R AML and MDS ongoingPhase 1 study in advanced solid tumors ongoingPhase 1 study ongoingPhase 1 study ongoingASP2138Phase 1 study to start in Q1 FY2022ASP7317Screening and enrollment in Phase 1b study put on hold, due to a manufacturing delayGene regulation & mitochondrial biogenesisMitochondria BiologyPrimary Focus CandidatesMitochondrial stressMitochondrial transferImmune modulating/regulatory cellsTissue-specific immune regulationTargeted protein degradationASP1128ASP0367TerminatedPhase 2/3 study in PMM ongoingPhase 1b study in DMD ongoingASP8731FSFT in Phase 1 study in Mar 2022ASP3082Phase 1 study to start in Q1 FY202213ModalitySmall moleculeAntibodyGeneCellOther1. Not exhaustively listed. AAV: Adeno-associated virus, UDC: Universal donor cell, FDA: Food and Drug Administration, R/R: Relapsed and refractory, AML: Acute myeloid leukemia, MDS: Myelodysplastic syndrome, FSFT: First subject first treatment, PMM: Primary mitochondrial myopathies, DMD: Duchenne muscular dystrophyPROGRESS IN FOCUS AREA APPROACH (2/2): SUMMARY OF FY2021Achievement in FY2021No. of projects aiming PoC by end FY25Number of new drug candidates 2Phase 1 entryPoC achievedCSP2021 3PoC not achievedAs of Apr 2022Primary FocusBiology/Modality/Technology 1Genetic regulationGene replacement (AAV)Gene regulation (AAV)CheckpointArtificial adjuvant vector cell (aAVC)Immuno-OncologyOncolytic virus (intratumoral)Oncolytic virus (systemic)Bispecific immune cell engagerCancer cell therapy (UDC)Blindness & RegenerationCell replacementCell replacement (UDC)Gene regulation (AAV)Gene regulation & mitochondrial biogenesisMitochondria BiologyMitochondrial stressMitochondrial transferImmune modulating/regulatory cellsTissue-specific immune regulationTargeted protein degradationPrimary Focus CandidatesOthers1111592(ASP1570, ASP2138)1(ASP8731)1(ASP3082)14ModalitySmall moleculeAntibodyGeneCellOtherTerminated before PoC judgement3(AT702, AT751, AT753)1(preclinical project)2(ASP1948, ASP1951)1(ASP1128)7153514123411. Not exhaustively listed. 2. Number of therapeutic entities that entered the preparation phase toward IND (Investigational New Drug)/clinical development. 3. Estimated based on standard development timelines, assuming 100% probability of success (at CSP2021 announcement).CSP: Corporate Strategic Plan, PoC: Proof of concept (key clinical data supporting a decision to initiate late-stage development), AAV: Adeno-associated virus, UDC: Universal donor cellTotal40314324PROGRESS IN Rx+ PROGRAM (1/2): SUMMARY OF FY202115Key events expected in FY2021 (announced in Apr 2021)Sphere *ProgramEventChronic disease progression preventionFit-eNceGame application for exercise supportInitiation of pilot marketing for at-home service (Fit-eNce Home)Initiation of pilot marketingBlueStarInitiation of clinical study (Japan)My Holter IICommercialization of servicePatient outcome maximizationpudexacianinium chloride(ASP5354)Topline results for Phase 2 studyOther updates Partnering with Nitto and M. Heart for ECG testing service (Sep 2021)ResultTimingSep 2021Not achieved(Product specifications under investigation)Not achieved(Clinical strategy under investigation)Jul 2021Nov 2021(: Achieved)* Business areas to focus on for realization of Rx+ StoryECG: ElectrocardiographyPROGRESS IN Rx+ PROGRAM (2/2): PUDEXACIANINIUM CHLORIDE (ASP5354)Pudexacianinium showed favorable efficacy and safety in Phase 2 study, which support further development16Results of Phase 2 studyNext steps Phase 3 study is planned to start in FY2022 Regulatory submission for the U.S. is planned in FY2023 Business partnership with a device manufacturer is under consideration for commercialization Pudexacianinium enhanced intraoperative ureter visualization under near-infrared fluorescence conditions Pudexacianinium appeared safe and well-tolerated; To date, no safety issues have been reported, no clinically relevant changes in vital signs, ECG or hematology, biochemistry or urine analysis. No related SAE and only 1 TEAE assessed as related by the investigator (grade 1 = mild proteinuria). 1.0 mg/patient pudexacianinium is the effective dose for intraoperative ureter visualization0.3 mg1.0 mg3.0 mg30 minEnd of surgeryUreter Visualization at 30 Minutes Post Pudexacianinium Administration and at End of SurgeryParticipants undergoing laparoscopic, minimally invasive colorectal surgerysingle intraoperative IV dose of 0.3 mg, 1.0 mg, or 3.0 mg The green signal indicates the fluorescence from pudexacianinium, which is the location of the ureter(SAGES conference in March 2022)ECG: Electrocardiography, SAE: serious adverse event, TEAE: treatment-emergent adverse events, IV: intravenous, SAGES: Society of American Gastrointestinal and Endoscopic Surgeons REVIEW OF THE FIRST YEAR OF CSP2021 Performance Goals are achievable despite some challengesRevenue, Pipeline Value1XTANDI and Strategic products*: ≥ ¥1.2T in FY2025Core OP Sales growth by 19% YoY, on track toward the target Achieved most of the expected key development milestonesProgress in CSP2021 As expected Recognized as challenge175 Flat SG&A in absolute termsSufficient R&D investments Core OP margin of ≥ 30% in FY202567 Steady increase in dividends Strategic upfront investment for future growth Increase of SG&A more than expected (increased investment for future growth such as OHG activities, DX and new products could not be covered by reduction of traditional cost spending)28StrategicproductsCoGsXTANDICo-ProSG&AR&D≥ ¥1.2T1XTANDI5≥ ¥0.5T4FocusAreaprojectsCoreOP6≥ 30%Future growth 8 Rx+: Breakeven by FY2025 First commercialization of service ASP5354: progress to Phase 39 Sustainability Disclosure aligning with TCFD recommendations Update of materiality matrix24Post-PoC projects from Primary Focuses3 Multiple technology platformsFocus Area projects:≥ ¥0.5T in FY2030 New drug candidates in 9 projects, Phase 1 entry in 4 projects Judgement in 7 projects No progress to Post-PoC stage from Primary Focus Clinical hold of AT132Sales by Products P&LSales by Products P&LSales by Products P&LFY25FY30FY20379Strategic products: XOSPATA, PADCEV, zolbetuximab, EVRENZO, fezolinetant, AT132CSP: Corporate Strategic Plan, PoC: Proof of concept, OHG: Organizational Health Goals, DX: Digital transformation, TCFD：Task Force on Climate-related Financial DisclosuresAGENDA18IFY2021 Consolidated Financial ResultsIIInitiatives for Sustainable GrowthIIIFY2022 Forecasts and Key Expected EventsFY2022 FORECAST: OVERVIEW19 Revenue and Profit to increase in FY2022Core 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 for Primary Focus and investment for new product launch readiness (mainly for fezolinetant and zolbetuximab);reviewing costs not contributing to competitiveness and increase of value.Control SG&A strictly by cost reduction from global optimization of personnel, thorough reduction of mature products-related costs and optimization of procurement costs.Aiming to improve the labor productivity of Astellas by “Dansharism*” movement Dividend per share: Forecasted 10 yen increase to 60 yenStrategic products: XOSPATA, PADCEV, EVRENZO*Dansharism: Please refer to slide 28 in appendixFY2022 FORECAST20(billion yen)RevenueSG&A expensesUS XTANDI co-pro feeSG&A excl. the aboveR&D expensesCore operating profitOperating profitProfitFY2021actualFY2022forecastChange (%)FY2022 FCST (FX rate)USD: 120 yenEUR: 135 yen1,296.21,443.0548.8139.3409.5246.0244.7155.7124.1598.0182.0416.0254.0290.0269.0208.0+11.3%+9.0%+30.6%+1.6%+3.2%+18.5%+72.8%+67.6%Impairment losses on intangible assets due to termination of development for AT702, AT751, AT753 to be booked in Q1/FY2022 ($170M)*Already included this impact into full-year forecast (full basis)FY2022 FORECAST: XTANDI AND STRATEGIC PRODUCTS21FY2022 ForecastFY2022 initiatives and growth factorsXTANDIXOSPATAPADCEVEVRENZO642.5 billion yen+108.2, YoY (+20%)46.2 billion yen+12.1 (+36%)36.5 billion yen+14.8 (+68%)9.9 billion yen+7.3 (+281%)• Expand sales in M1 CSPC in US, Japan and International Markets• Continue strong growth in M1 CRPC in China• Expect continued growth in US, Established Markets and sales contribution from International Markets due to the increase of launched countries• Expect continued growth in US within the current US indication• Continued market share gain in Japan, launched in Dec 2021• Launch in priority EU countries and the preparation for reimbursement• Expect growth in Japan whilst reinforcing market position in the HIF-PHI class• Secure reimbursement in European countries and drive market share growth • Expect sales contribution from International MarketsStrategic products: XOSPATA, PADCEV, EVRENZOM1: Metastatic, CSPC: Castration-sensitive prostate cancer, CRPC: Castration-resistant prostate cancer, HIF-PHI: Hypoxia-inducible factor prolyl hydroxylase inhibitorXTANDI & STRATEGIC PRODUCTS: KEY EVENTS EXPECTED IN FY202222enzalutamide / XTANDIenfortumab vedotin / PADCEVfezolinetantAT132Q1Q2Q3Q4EMBARK TLR 1EV-103 Cohort K TLR 1Filing (M0 CSPC; US)China ARCHES TLR 1Regulatory submissionData readoutOthersEV-202 TLR (other solid tumors; initial results) 1Filing (1L mUC; US)EV-203 TLR (pre-treated mUC; China) 1zolbetuximab*Education and awareness activities for Claudin 18.2• Disease state and biomarker education for HCPs managing gastric cancer and for pathologists• Multiple initiatives to help ensure Claudin 18.2 test availability at launch, including publications on exploratory biomarkers and clinical trial data•Initiatives to support payers understanding and awareness of Claudin 18.2 biomarker and its relevance as an important target in metastatic gastric cancerSPOTLIGHT TLR 1GLOW TLR 1* Target filing timeline shifted to FY2023Filing (US)Education and awareness activities for VMS• Disease state education and awareness intended to reach over 100K HCPs and over 10M women• VMS educational discussions with payers to highlight the impact on their customers lives and the clinical and economic burden• Data driven omnichannel communications designed to optimize reach and engagement through non-personal (including digital) and personal activities Filing (EU)1. The timeline of TLR is subject to shift due to its event-driven nature.TLR: Topline results, M0 CSPC: Non-metastatic castration-sensitive prostate cancer, 1L: First line, mUC: Metastatic urothelial cancer, VMS: Vasomotor symptoms, HCP: Healthcare Professionals,FDA: Food and Drug AdministrationResponse to FDA clinical holdPOTENTIAL PEAK SALES: XTANDI AND STRATEGIC PRODUCTS (UPDATE)23Assumptions reviewed for each product, expect continued strong growthDownward revision of potential peak sales for AT132, reflecting the latest situation ProductPotential Peak Sales(Global, billions of yen)Assumptions UpdateXTANDI (enzalutamide)fezolinetantPADCEV (enfortumab vedotin) 1XOSPATA (gilteritinib)zolbetuximabEVRENZO (roxadustat) 2600 – 700 300 – 500 300 – 400100 – 200100 – 20050 – 100 Reviewed assumptions for XTANDI, PADCEV and XOSPATA, taking into account the global competitive environment, recent sales and prescription trends (duration and treatment rate), and ongoing clinical studies Reviewed assumptions for fezolinetant, taking into account the latest market research, number of patients, and the results of Phase 3 studies obtained in FY2021 As a result of the review, potential peak sales remains unchanged Reviewed assumptions taking into account the competitive environment for zolbetuximab, and recent sales trend and market environment for EVRENZO. Potential peak sales revised downward within rangeAT132 (resamirigene bilparvovec)under 50 3 Potential peak sales revised downward based on the assumptions of the delay of approval timing and change in target patient populationNote) Only indications undergoing pivotal studies are included for projection (as of April 2022)1. Sales for Americas are calculated based on the sales booked by Seagen, 2. Astellas territories only; Japan, Europe, the Commonwealth of Independent States, the Middle East, South Africa, etc.3. Previous potential peak sales: 50 – 100 billion yen (announced in May 2021)FOCUS AREA APPROACH:CLINICAL PROOF AND EXPANSION OF KEY PLATFORMSExpecting PoC judgement in 2 projects, Phase 1 entry in 5 projects (lead and follow-on projects)24Primary FocusBiology/Modality/Technology 1Lead projectFY22FY23FY24-25No. of projects aiming PoCby end FY25 2Genetic regulationGene replacement (AAV)Gene regulation (AAV)CheckpointArtificial adjuvant vector cell (aAVC)Immuno-OncologyOncolytic virus (intratumoral)Oncolytic virus (systemic)Blindness & RegenerationCancer cell therapy (UDC)Cell replacementCell replacement (UDC)Gene regulation (AAV)Mitochondria BiologyMitochondrial stressMitochondrial transferPrimary Focus CandidatesImmune modulating/regulatory cellsTissue-specific immune regulationBispecific immune cell engagerASP2138Gene regulation & mitochondrial biogenesis ASP0367PoCINDPoCINDINDAT132AT845ASP1570ASP7517ASP9801ASP7317ASP8731ModalitySmall moleculeAntibodyGeneCellOtherStage of the most advanced project in the categoryDiscovery/ PreclinicalPre-PoCPost-PoCPOC PoC judgementINDPhase 1 entry of lead projectINDPhase 1 entry of follow-on project124341Targeted protein degradationASP3082INDTotal241. Not exhaustively listed. 2. Estimated based on standard development timelines, assuming 100% probability of success (as of Apr 2022)PoC: Proof of concept (key clinical data supporting a decision to initiate late-stage development), AAV: Adeno-associated virus, UDC: Universal donor cellRx+ PROGRAM: KEY EVENTS EXPECTED IN FY202225CategoryProgramEventEG HolterInitiation of pilot marketingDigital healthOther servicesDigital therapeuticsBlueStarInitiation of clinical study (Japan)Drug-devicecombinationpudexacianinium chloride (ASP5354)FSFT in Phase 3 study Implantable medical devices (iota): Prepare for IDE submission in FY2022, toward initiation of clinical study in FY2023IDE：Investigational Device Exemption, FSFT: First subject first treatmentCONCLUSION: TOWARD MID- TO LONG-TERM GROWTH TREND26Product portfolio has changed and sales of XTANDI and Strategic products growing significantlyRecord revenue increase in FY2021 for the first time since FY2018Continued growth in FY2022 and aiming to achieve rich development milestones(billion yen)Revenue trend+11% YoY+4% YoYKey development milestones in FY2022• XTANDI: Filing M0 CSPC in US• fezolinetant: Filing in US and EU• PADCEV: Filing mUC 1st line in US• zolbetuximab: Topline results for Phase 3 studiesOtherPrografmirabegronStrategic productsXTANDI1,400.01,200.01,000.0800.0600.0400.0200.00.0Strategic products: XOSPATA, PADCEV, EVRENZOM0: Non-metastatic, CSPC: Castration-sensitive prostate cancer, mUC: Metastatic urothelial cancerFY18 ActFY19 ActFY20 ActFY21 ActFY22 FCSTAPPENDIX“DANSHARISM” MOVEMENT Perfectly fitting for a Japanese company, expanding the concept of “Danshari,” which is the thoroughly elimination of28waste, globally and into daily operations At the same time, ensuring that managers have financial discipline and cost ownership, and transforming into an organization that creates innovation by improving our labor productivity Having a mindset that enables us to invest resources into new initiatives while maintaining the absolute amount of SG&A expenses1. Thoroughly reevaluate our work and activities without exception2. Define what work to halt or terminate 3. Actually halting or terminating that workTarget :All work, including accepted practices continuing on from the past, old work processes, and routine workSpecification:Specify work that bring “less” ROI or are “less” priorityExecution :Be “courageous” and halt work that was specified in order of less importance and eventually secure a white space for employees Classification :Categorize each work with a “Must have” or “Nice to have” perspective(Example)Existing old processes, reports of similar content, reports of excessive quality, review of meeting attendees, etc.Consequently, invest resources in new thingswhile reducing costsBuilding an environment that enables the creation of innovation in a sustainable manner through thorough efficiency improvementsWhat is “Danshari”? -Japanese minimalism-It is the Japanese concept of “decluttering” and is the process of cutting out what is unnecessary, detaching from things, and readjusting one’s life accordingly.ROI: Return On Investment, White space: Resources needed to explore new ideasFY2021 FINANCIAL RESULTS: REVENUE29Revenue increase driven by growth of XTANDI and Strategic products, which offset sales decrease due to termination of sales and distribution / transfer of productsFY2020FY2021ChangeChange (%)Revenue1,249.5 bil. yen1,296.2 bil. yen+46.6 bil. yen+3.7%Increase in XTANDI and Strategic productsXTANDI, XOSPATA, PADCEV, EVRENZO Recovered sales level of Lexiscan, negatively impacted by COVID-19 in Q1/FY20 +15.5 bil. yenTermination of sales and distribution / transfer of products+96.5 bil. yen-39.0 bil. yenCelecox, Lipitor, EligardStrategic products: XOSPATA, PADCEV, EVRENZOFY2021: REVENUE BY REGION30(billion yen)FY2020FY2021Change (%)JapanUnited States258.8-7.3%537.5+13.6%Established Markets315.2+7.5%Greater China66.3+11.8%International Markets110.1-0.9%Established Markets: Europe, Canada, AustraliaGreater China: China, Hong Kong, TaiwanInternational Markets: Russia, Latin America, Middle East, Africa, South East Asia, South Asia, Korea, Export sales, etc.279.1473.2293.259.3111.1FY2021: SALES OF MAIN PRODUCTS31(billion yen)FY2020FY2021ChangeCER growthFY21FCST*XTANDI458.4534.3+16.6%+10.6%554.1XOSPATAPADCEVEVRENZO23.812.81.134.121.7+42.9%+35.6%+69.5%+60.8%2.6+131.5%+131.0%mirabegron163.6172.3+5.3%+0.7%Prograf182.7185.4+1.5%-3.8%35.420.77.2176.3185.7PADCEV (US): Co-promotion revenue from Seagenmirabegron (Product name: Betanis/Myrbetriq/BETMIGA)Prograf: Incl. Advagraf/Graceptor/ASTAGRAF XL*Announced in Oct 2021FY2021 FINANCIAL RESULTS: BUSINESS UPDATE FOR MAIN PRODUCTS32XTANDI XOSPATAPADCEVEVRENZOGlobal 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 of COVID-19 (less sales promotion activities/ fewer patients entering the market) and increased impact from competition. In the EU, delay of reimbursement approvals (M1 HSPC), increased pricing pressure and competitionimpacted net salesSales across regions steadily expanded and global sales were slightly behind forecast. Initial sales trend is positive thus far in China – launched in Apr 2021 (FY21 sales: 1.5 billion yen).Recent approvals in International Markets will contribute to the future growth of XOSPATAGlobal sales exceeded full year forecast.Revenue in the US grew steadily as expected following approval of additional indication in Jul 2021.Further global launches occurred in FY2021: Japan (Nov 2021), Switzerland (Dec 2021)Initial PADCEV uptake has been very strong thus far in Japan and exceeded expectations (FY21 sales: 1.8 billion yen)Overall sales performance was behind full-year forecast. While sales grew YoY, performance was behind expectations due to intense competition from other HIF-PHIs in Japan and a slightly later and slower launch in Germany, Netherlands and UKmirabegronGlobal sales increased, driven by growth mainly in Japan and Established Markets, but did not achieve full-year forecast. In the US, Myrbetriq sales were behind full-year forecast due to lower than expected US OAB market growth and increased pricing pressureM1 HSPC: Metastatic Hormone-sensitive prostate cancer, HIF-PHI: Hypoxia-inducible factor prolyl hydroxylase inhibitor, OAB: Overactive bladder FY2021 ACTUAL: FX RATE33Average rate for the periodFY2020FY2021Change106 yen124 yen112 yen131 yen+6 yen+7 yenCurrencyUSDEURCurrencyUSDEURChange in closing rate from previous fiscal year endFY2020FY2021+2 yen+10 yen+11 yen+5 yen 59.6 billion yen increase in revenue, 18.5 billion yen increase in core OP FX impact on elimination of unrealized gain: COGs ratio +0.2 pptFY2022 FCST： FX RATE & FX SENSITIVITY34Average rate for the periodFY2021FY2022 FCSTchangeChange in closing rate from the previous FY endFY2021FY2022 FCST112 yen131 yen+11 yen+5 yen120 yen135 yen-2 yen+0 yenEstimated FX sensitivity of FY2021 forecast by 1 yen appreciation+8 yen+4 yenAverage rate1 yen higher than assumptionYear-end rate1 yen higher thanassumptionRevenueCore OPCore OPApprox. -6.6 bil. yenApprox. -1.1 bil. yenApprox. +0.6 bil. yenApprox. -2.8 bil. yenApprox. -1.2 bil. yenApprox. +0.2 bil. yenCurrencyUSDEURCurrencyUSDEURCurrencyUSDEURBALANCE SHEET & CASH FLOW HIGHLIGHTS35Cash and cash equivalentsTotal equity attributable to owners of the parent(billion yen)Total assetsEquity ratio (%)(billion yen)Cash flows from operating activitiesCash flows from investing activitiesFree cash flowsCash flows from financing activitiesBonds and short-term borrowingsProceeds from long-term borrowingsRepayments of long-term borrowingsAcquisition of treasury sharesDividends paidFY2020 endFY2021 endFY2020FY20212,273.6326.11,386.161.0%306.8-81.9224.9-229.5-206.080.0–9.2-76.22,332.4316.01,460.362.6%257.4-62.4195.0-216.3-30.0–30.0-50.7-85.2Balance of bonds and borrowings：140.0 billion yen(Decreased by 60.0 billion yen from FY2020 end)CAPITAL ALLOCATION1Top priority is investment for business growth 2Raise dividend level aligned with profit / cashflow plan and actual performance throughout CSP2021 period3Flexibly execute share buyback by excess cashAiming for higher level of dividends increase during CSP2021 aligned with the robust profit growth forecastDividends(yen)100Trend of Core OP and dividendsCore OP(billion yen)6006,00036Acquisition of own shares announced in Feb. 2022 From Feb. 3 to Mar. 9, 2022 26 million shares 50.0 billion yenDividendsCore OP*8060402001450YF1660YF* Prior to FY2012, operating profit is in accordance with J-GAAPCSP: Corporate Strategic Plan2224252525262730323436384042605070YF80YF90YF01YF11YF21YF31YF41YF51YF61YF71YF81YF91YF02YF12YF22YF32YF42YF52YF5005,0004004,0003003,0002,0002001,0001000For illustrative purposes onlyPROGRESS IN FOCUS AREA APPROACH: NEW CLINICAL PROGRAMSFirst-in-class programs from Focus Area approach entered clinical phase ASP1570 (PF Immuno-Oncology) Small molecule DGKζ inhibitor Target disease: Cancer DGKζ expressed in T cells down regulates adoptive immune responses against tumor cell growth DGKζ inhibition potentiates T cell activation and promotes immune-mediated tumor killing. The mechanism is separate from, and downstream to, current checkpoint inhibitors ASP8731 (PF Mitochondria Biology) Small molecule BACH1 inhibitor Target disease: Sickle Cell Disease Serious and lifelong health condition Cause major organ damage, impacting quality of life and reducing life expectancy ASP8731 upregulates cytoprotective transcription and addresses the root cause of sickle cell diseaseTCRHigh expression of DGKζinduces T cell anergyASP8731ASP8731 inhibits BACH1, releasing negative regulation of Nrf2DGKζDAGPABACH137Redox balanceAnti-inflammatoryProteostasisAnti-sickling (HbF γ-globin)Anti-adhesionT cell activationASP1570ASP1570 activates T cells through DGKζ inhibitionBACH1MafNrf2MafAREAREPF: Primary Focus, DAG: Diacylglycerol, DGK: Diacylglycerol kinase, PA: Phosphatidic acid, BACH1: BTB and CNC homology 1, ARE: Anti-oxidant response element, HbF: Fetal hemoglobinROBUST PIPELINE OF ASTELLAS38Phase 1Phase 2Phase 3enfortumab vedotin(NMIBC)gilteritinib (Newly diagnosed AML, HIC-ineligible)ASP7317bocidelpar/ASP0367(Duchenne muscular dystrophy)ASP9801ASP7517(Solid tumors)ASP0739AT845ASP0598ASP1570ASP2138ASP8731ASP3082ASP8062(Alcohol use disorder)enfortumab vedotin(Other solid tumors)zolbetuximab(Pancreatic adenocarcinoma)roxadustat(Chemotherapy-induced anemia)resamirigene bilparvovec/AT132 (XLMTM)ASP7517(AML and MDS)bocidelpar/ASP0367(Primary mitochondrial myopathies)FX-322(Sensorineural hearing loss)isavuconazole(Pediatric use: US)ASP8062(Opioid use disorder)enzalutamide (M0 CSPC, M1 CSPC: China)gilteritinib (Earlier-stage AML, pediatric use)enfortumab vedotin(mUC previously untreated, MIBC)zolbetuximab(Gastric and GEJ adenocarcinoma)fezolinetant(VMS associated with menopause)peficitinib(Rheumatoid arthritis: China)mirabegron (Pediatric use: EU)XTANDI and Strategic products(XOSPATA, PADCEV, zolbetuximab, EVRENZO, fezolinetant, AT132)Projects with Focus Area approachOthersPlease refer to R&D pipeline list for details including target disease.NMIBC: Non-muscle-invasive bladder cancer, AML: Acute myeloid leukemia, HIC: High-intensity chemotherapy, XLMTM: X-linked myotubular myopathy, MDS: Myelodysplastic syndrome, M0: Non-metastatic, M1: Metastatic, CSPC: Castration-sensitive prostate cancer, mUC: Metastatic urothelial cancer, MIBC: Muscle-invasive bladder cancer, GEJ: Gastroesophageal junction, VMS: Vasomotor symptomsPROGRESS IN OVERALL PIPELINEPhase 1 Entry to Approval since the Last Financial Results Announcement39Phase 1 EntryPhase 2 EntryPhase 3 EntryFilingApprovalASP8731Sickle cell diseaseASP3082Cancerenfortumab vedotinLocally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a PD-1/L1 inhibitor: EUDiscontinuationASP1951: Cancer (Phase 1)ASP1128: Acute kidney injury (Phase 2)ASP3772: Prevention of pneumococcal disease (Phase 2)ASP2390: House dust mite-induced allergic rhinitis (Phase 1)Note: Phase 1 entry is defined as confirmation of IND open. Phase transition is defined by approval of company decision body for entering to next clinical phase.Filing is defined as submission of application to health authorities.Discontinuation is defined by the decision of company decision body.AML: Acute myeloid leukemia, IND: Investigational New DrugXTANDI & STRATEGIC PRODUCTS: STATUS UPDATE(Red: Updates since the last financial results announcement)40Project / ProductIndicationenzalutamide /XTANDIM1 CSPCCurrent status• US: Filed label update to include the OS data in Dec 2021• EU: CHMP positive opinion received for label update to include the OS data in Mar 2022• China: Phase 3 study ongoing (enrollment completed)M0 CSPC• Phase 3 study ongoing (enrollment completed)gilteritinib /XOSPATARelapsed and refractory AML• China: Phase 3 study stopped due to efficacyAML, post-HSCT maintenance• Phase 3 study ongoing (enrollment completed)AML, newly diagnosed (HIC-eligible)• Phase 3 study ongoingAML, newly diagnosed (HIC-ineligible)• Phase 1 study under preparation to start in Q3 FY2022AML, post-chemotherapy• Data of Phase 2 GOSSAMER study presented at AACR in Apr 2022enfortumab vedotin / PADCEVMetastatic urothelial cancer• Pretreated: Approved in EU in Apr 2022• Previously untreated (first line): Phase 3 study ongoing• China: Phase 2 bridging study ongoing (enrollment completed)Muscle-invasive bladder cancer• Phase 3 studies ongoing. Cohort H data in EV-103 study presented at ASCO GU in Feb 2022Non-muscle-invasive bladder cancer• Phase 1 study ongoingOther solid tumors• Phase 2 study ongoingzolbetuximabGastric & GEJ adenocarcinoma• Phase 3 studies ongoing (enrollment completed)Pancreatic adenocarcinoma• Phase 2 study ongoingChemotherapy-induced anemia• Obtained topline results of Phase 2 studyVMS associated with menopause• US & EU: Obtained 52w data of Phase 3 pivotal studies (SKYLIGHT 1 and SKYLIGHT 2) and long-term study (SKYLIGHT 4). Phase 3b DAYLIGHT study ongoing. 12w data from Phase 3 SKYLIGHT 1 study to be presented at ACOG in May 2022. 52w data from Phase 3 SKYLIGHT 2 study to be presented at ENDO in Jun 2022• Asia: Obtained 12w data of Phase 3 pivotal study (MOONLIGHT 1) in Mar 2022, LSLV in Apr 2022. Phase 3 long-term study (MOONLIGHT 3) ongoing (enrollment completed)• Japan: Phase 2b STARLIGHT study ongoingX-linked myotubular myopathy• ASPIRO study put on clinical hold by FDA due to a serious adverse eventroxadustat /EVRENZOfezolinetantAT132 (resamirigene bilparvovec) Strategic products: XOSPATA, PADCEV, zolbetuximab, EVRENZO, fezolinetant, AT132. M1: Metastatic, M0: Non-metastatic, CSPC: Castration-sensitive prostate cancer, OS: Overall survival, CHMP: Committee for Medicinal Products for Human Use, AML: Acute myeloid leukemia, HSCT: Hematopoietic stem cell transplant, HIC: High-intensity chemotherapy, AACR: American Association for Cancer Research, ASCO GU: American Society of Clinical Oncology Genitourinary Cancers Symposium, GEJ: Gastroesophageal junction, VMS: Vasomotor symptoms, ACOG: American College of Obstetricians and Gynecologists, ENDO: Endocrine Society, LSLV: Last subject last visit, FDA: Food and Drug AdministrationXTANDI & STRATEGIC PRODUCTS: REGULATORY TIMELINE (UPDATE)41Expand additional indications for XTANDI, XOSPATA and PADCEVExpect new launch for zolbetuximab, fezolinetantProductXTANDI(enzalutamide)XOSPATA(gilteritinib)PADCEV(enfortumab vedotin)zolbetuximabfezolinetantAT132(resamirigene bilparvovec)FY2021FY2022FY2023FY2024FY2025 or laterTarget Filing TimingM0 CSPCAML, post-HSCT maintenanceAML, newly diagnosedand HIC-eligiblemUC, previously untreated (AA in US)based on EV-103 study cohort datamUC, previously untreated (1L)MIBCGastric and GEJ adenocarcinomaModerate to severe VMS associated w/ menopauseXLMTMNote) Only indications undergoing pivotal studies are included (as of Apr 2022). Subject to internal assessment, decision and regulatory consultation, as appropriate. Filing (submission) timing in the first country/region within US, EU, JPM0 CSPC: Non-metastatic castration-sensitive prostate cancer, AML: Acute myeloid leukemia, HSCT: Hematopoietic stem cell transplantation, HIC: High-intensity chemotherapy, mUC: Metastatic urothelial cancer, AA: Accelerated Approval, 1L: First line, MIBC: Muscle-invasive bladder cancer, GEJ: Gastroesophageal junction, VMS: Vasomotor symptoms, XLMTM: X-linked myotubular myopathyENZALUTAMIDE (1/2): ANDROGEN RECEPTOR INHIBITOR(Red: Updates since the last financial results announcement)42US/EU/JPDefinitive TherapyCastration-SensitiveCastration-ResistantInitial DiagnosisSurgerySalvageActive SurveillanceRadiationARCHESM1 CSPCnewly-diagnosed M1 CSPCrecurrentLaunchedEMBARKEMBARKM0 CSPCPROSPERM0 CRPCLaunchedPREVAILM1 CRPC(1st line)AFFIRMM1 CRPC(2nd line+)LaunchedLaunchedP3: ARCHES M1 CSPC Combo with ADT, vs. placebon=1,150Approved in US in Dec 2019, in JP in May 2020, and in EU in Apr 2021Filed label update to include the OS data in US and EU in Dec 2021. CHMP positive opinion received in Mar 2022P3: EMBARK M0 CSPC Combo with ADT, vs. placebon=1,068 Enrollment completedChina• M1 CSPC: Enrollment completed in Phase 3 China-ARCHES studyM1: Metastatic, M0: Non-metastatic, CSPC: Castration-sensitive prostate cancer, CRPC: Castration-resistant prostate cancer, ADT: Androgen deprivation therapy, OS: Overall survival, CHMP: Committee for Medicinal Products for Human UseENZALUTAMIDE (2/2): PHASE 3 STUDY DATA BY DISEASE STAGE43Continued potential in earlier lines with consistent survival benefit and longer duration of treatmentDisease stageEarly stageLate stageCastration-sensitive (CSPC)Castration-resistant (CRPC)M0M1M0M1(pre-chemo)M1(post-chemo)Phase 3 studyEMBARKARCHESENZAMETPROSPERPREVAILAFFIRMControlPlaceboPlaceboPlaceboPlaceboPlaceboConventionalNSAAPrimary endpointMFS(Ongoing)OSDoT(Ongoing)(Ongoing)✔ rPFSHR 0.39✔HR 0.66✔ OSHR 0.67✔HR 0.67✔ MFSHR 0.29✔HR 0.73✔ rPFSHR 0.17✔ OSHR 0.71*✔HR 0.77✔ OSHR 0.63✔HR 0.63✔40.2 months✔29.5 months✔33.9 months✔17.5 months✔8.3 months✔: Data obtained, *: Prespecified interim analysisM0: Non-metastatic, M1: Metastatic, CSPC: Castration-sensitive prostate cancer, CRPC: Castration-resistant prostate cancer, NSAA: Non-steroidal antiandrogen, HR: Hazard ratio, MFS: Metastasis-free survival, rPFS: Radiographic progression-free survival, OS: Overall survival, DoT: Duration of treatmentGILTERITINIB: FLT3 INHIBITOR(Red: Updates since the last financial results announcement)44FLT3 mut+AMLChemo consolidationTransplantMaintenanceGOSSAMERMaintenanceMORPHOADMIRALSalvage therapyLaunchedPASHA (HOVON)PrE0905 (PrECOG)High-intensity inductionchemoLow-intensity chemoP1 (triplet)Relapsed or refractoryP3: ADMIRALn=371Launched in US, JP, and EUNewly diagnosed(HIC-eligible)P3: PASHA (HOVON)P2: PrE0905 (PrECOG)Monotherapy vs. salvage chemo (2:1)Combo with high intensity chemo gilteritinib vs. midostaurin (1:1)n=768FSFT: Dec 2019 (Sponsor: HOVON)n=179FSFT: Dec 2019 (Sponsor: PrECOG, LLC.)Enrollment completedCollaborating with BMT-CTNPost-HSCT maintenance P3: MORPHOMonotherapy vs. placebo (1:1) n=346Post-chemo maintenance P2: GOSSAMERMonotherapy vs. placebo (2:1) n=98Data presented at AACR in Apr 2022Newly diagnosed (HIC-ineligible)P1Combo with venetoclax and azacitidineTBDTo start in Q3 FY2022China • R/R AML: Conditional approval obtained in Jan 2021, based on ADMIRAL study data (full approval contingent on COMMODORE study data) and launched in Apr 2021. Phase 3 COMMODORE study (including China and other countries) stopped due to efficacy based on the planned interim analysisFLT3 mut+: FLT3 mutation positive, AML: Acute myeloid leukemia, HIC: High-intensity chemotherapy, FSFT: First subject first treatment, HSCT: Hematopoietic stem cell transplant, HOVON: The Haemato Oncology Foundation for Adults in the Netherlands, AACR: American Association for Cancer Research, BMT-CTN: Blood and Marrow Transplant – Clinical Trial Network, R/R: Relapsed or refractoryENFORTUMAB VEDOTIN (EV) (1/4): NECTIN-4 TARGETED ADCOVERALL UC PROGRAM(Red: Updates since the last financial results announcement)45Early stageNMIBCStages 0a-1- Disease stage of urothelial cancer -Late stageMIBCStages 2 and 3mUCStage 4PatienttreatmentBCG-unresponsiveRC-eligiblePreviously untreated(first line)PD-1/L1 inhibitor pretreatedPlatinum and PD-1/L1 inhibitor pretreatedTargetEV regimenEV mono(intravesical)P1: EV-104Clinical studies for EVPhase 3Phase 1 or 2EV+Pembro combo(i.v.; perioperative)P3: KEYNOTE-905/ EV-303Cis-ineligiblevs. SoC (RC alone)P3: KEYNOTE-B15/ EV-304Cis-eligiblevs. SoC (NAC + RC)(Cohorts H & L)Cis-ineligible EV mono (neoadjuvant /perioperative) + RCEV+Pembrocombo (i.v.)EV mono(i.v.)EV mono(i.v.)P3: EV-302Platinum-eligiblevs. ChemoP1b/2: EV-103(Dose escalationcohort & Cohort A)Cis-ineligible(Cohort K)Cis-ineligibleEV mono vs. EV + PembroP2: EV-201 (Cohort 2)Platinum-naïve and cis-ineligiblesBLA approvedsBLA (to convert regular approval)approved in US.Approved in JP.and EUP2: EV-201(Cohort 1)P3: EV-301vs. ChemoP2: EV-203(Bridging studyin China)Approved(AA) &launched in USADC: Antibody-drug conjugate, mUC: Metastatic urothelial cancer, NMIBC: Non-muscle-invasive bladder cancer, MIBC: Muscle-invasive bladder cancer, BCG: Bacillus Calmette-Guerin, RC: Radical cystectomy, mono: Monotherapy, Pembro: Pembrolizumab, i.v.: Intravenous, Cis: Cisplatin, SoC; Standard of care, NAC: Neoadjuvant chemotherapy, Chemo: Chemotherapy, sBLA: Supplemental Biologics License Application, AA: Accelerated ApprovalENFORTUMAB VEDOTIN (EV) (2/4): CLINICAL STUDIES(Red: Updates since the last financial results announcement)For urothelial cancer46P3: EV-301P3: EV-302P3: EV-303/KEYNOTE-905P3: EV-304/KEYNOTE-B15P2: EV-201mUC, Platinum and PD-1/L1 inhibitor pretreated; EV mono vs. ChemomUC, Previously untreated, Platinum-eligible; EV + Pembro vs. ChemoMIBC, Cis-ineligible; Pembro +/- EV (perioperative) + RC vs. RC alonen=608sBLA (to convert regular approval) approved in US in Jul 2021. Approved in JP in Sep 2021, in EU in Apr 2022n=860FSFT: Apr 2020n=836FSFT in Pembro + EV arm: Dec 2020MIBC, Cis-eligible; EV+Pembro (perioperative) + RC vs. Chemo (neoadjuvant) + RCn=784FSFT: May 2021mUC, PD-1/L1 inhibitor pretreated; EV monoCohort 1: Platinum pretreatedCohort 2: Platinum naïve and cis-ineligibleCohorts A – G and K (mUC): A-G: Combo with Pembro and other chemoK: EV mono vs. EV + PembroH: EV mono (neoadjuvant)J (optional): EV + Pembro (neoadjuvant)L: EV mono (perioperative)Cohort 1: Approved (under the Accelerated Approval program) n=219and launched in US in Dec 2019Cohort 2: sBLA approved in US in Jul 2021Cohort K: Enrollment completed in Oct 2021Cohort L: Enrollment ongoingNote) Data from Cohort K along with other cohorts evaluating EV + Pembro as first-line therapy for cis-ineligible patients could potentially support registration for Accelerated Approval in USmUC, Platinum and PD-1/L1 inhibitor pretreated; EV monon=40Enrollment completed in Jan 2022NMIBC, High-risk BCG-unresponsive; Intravesical EV monon=58FSFT: Jan 2022P1b/2: EV-103Cohorts H, J and L (MIBC, Cis-ineligible, + RC):n=457P2: EV-203P1: EV-104P2: EV-202For other solid tumorsHR+/HER2- breast cancer, Triple-negative breast cancer,Squamous NSCLC, Non-squamous NSCLC, Head and neck cancer, Gastric adenocarcinoma or esophageal carcinoma or GEJ adenocarcinoma, Esophageal squamous cell carcinoma; EV mono n=280FSFT: Mar 2020mUC: Metastatic urothelial cancer, mono: Monotherapy, Chemo: Chemotherapy, sBLA: Supplemental Biologics License Application, Pembro: Pembrolizumab, FSFT: First subject first treatment, Cis: Cisplatin, MIBC: Muscle-invasive bladder cancer, RC: Radical cystectomy, NMIBC: Non-muscle-invasive bladder cancer, BCG: Bacillus Calmette-Guerin, HR+: Hormone receptor positive, HER2-: HER2 negative, NSCLC: Non-small cell lung cancer, GEJ: Gastroesophageal junctionENFORTUMAB VEDOTIN (EV) (3/4): STUDY DATA BY DISEASE STAGE OF UC47Late stageEarly stageMIBCSurgery eligibleDisease stageCis-eligibleCis-ineligiblePlatinum eligibleCis-ineligiblePlatinum pretreatedPreviously untreated (first line)PD-1/L1 inhibitor pretreatedmUCPlatinum naïve and cis-ineligibleStudy phasePhase 3Phase 3Phase 3Phase 1b/2Phase 1b/2Phase 2Phase 2Phase 3Study No.KN-B15/ EV-304KN-905/ EV-303EV-302EV-103Cohort KEV-201 Cohort 2EV-201Cohort 1EV-301No. of subjects 784 (2 arms)836 (3 arms)860 (2 arms)150 (2 arms)89125608 (2 arms)EV-103Cohort A& Others45Combo w/ PembroChemon/an/an/an/aChemoMonoMonoMonoEV regimenCombo w/ Pembro(perioperative)Combo w/ Pembro(perioperative)Combo w/ PembroMono vs.Combo w/ PembroControlPrimary endpointOSPFSChemo(neoadjuvant)pCR&EFSSoCpCR&EFSPFS&OSORR(Ongoing)(Ongoing)(Ongoing)(Ongoing)(Ongoing)(Ongoing)(Ongoing)(Ongoing)ORR(Ongoing)(Ongoing)(Ongoing)(Ongoing)✔ ORR73% **(CR 16% **)✔(26.1 mos **)✔(12.3 mos **)✔ 73% **(CR 16% **)✔ ORR51% **(CR 22% **)✔(14.7 mos)✔(5.8 mos)✔ 52%(CR 20%)✔ ORR44%(CR 12%)✔(12.4 mos **)✔(5.8 mos)✔ 44%(CR 12%)✔ OSHR 0.70 *✔ HR 0.70 *(12.9 mos vs.9 mos)✔ HR 0.62 *(5.6 mos vs.3.7 mos)✔41% vs.18% *(CR 4.9% vs.2.7%)✔ 7.39 mosvs. 8.11 mos *DoR(Ongoing)(Ongoing)(Ongoing)(Ongoing) ✔ 25.6 mos ** ✔ 13.8 mos ** ✔ 7.6 mos✔: Data obtained, *: Prespecified interim analysis, **: Updated data(m)UC: (Metastatic) urothelial cancer, MIBC: Muscle-invasive bladder cancer, Pembro: Pembrolizumab, mono: Monotherapy, Chemo: Chemotherapy, pCR: Pathologic complete response, EFS: Event-free survival, ORR: Objective response rate, CR: Complete response, OS: Overall survival, HR: Hazard ratio, PFS: Progression-free survival, DoR: Duration of responseENFORTUMAB VEDOTIN (EV) (4/4): FUTURE OUTLOOK The most significant growth driver is 1L mUC indication, which is expected to account for more than half of total sales 48in the future Success in NMIBC and other solid tumors will provide further growth potentialSales Forecast (Image)MIBC1L mUC Peak300 – 400billion yenPatient segmentPivotal study(PADCEV regimen)Target filingtimingMIBC, cis-ineligibleEV-303 / KEYNOTE-905(combo w/ pembrolizumab)FY2025 or laterPatient segmentNMIBCHigh-risk BCG-unresponsiveOther solid tumorsStudy(PADCEV regimen)EV-104 [Phase 1](monotherapy,intravesical)EV-202 [Phase 2]*(monotherapy)*HR+/HER2- breast cancer, Triple-negative breast cancer, Squamous NSCLC, Non-squamous NSCLC, Head and neck cancer, Gastric adenocarcinoma or esophageal carcinoma or GEJ adenocarcinoma, Esophageal squamous cell carcinoma; MIBC,cis-eligibleEV-304 / KEYNOTE-B15(combo w/ pembrolizumab)FY2025 or latermUC, previously untreated (1L)mUC, PD-1/L1 inhibitor treated and cis-ineligiblemUC, platinum and PD-1/L1 inhibitor treatedEV-302EV-103 Cohorts[Phase 1b/2 for AA in US](combo w/ pembrolizumab)FY2024FY2022[AA in US]EV-201 Cohort 2 [Phase 2](monotherapy)ApprovedEV-301EV-201 Cohort 1[Phase 2 for AA in US](monotherapy)ApprovedFY21FY25FY302L+ mUC1L mUCMIBCBased on internal estimatesmUC: Metastatic urothelial cancer, MIBC: Muscle-invasive bladder, 1L: First line, 2L+: Second or later line, cis: Cisplatin, AA: Accelerated Approval, HR+: Hormone receptor positive, HER2-: HER2 negative, NSCLC: Non-small cell lung cancer, GEJ: Gastroesophageal junctionZOLBETUXIMAB: ANTI-CLAUDIN 18.2 MONOCLONAL ANTIBODY(Red: Updates since the last financial results announcement)49Target: Claudin 18.2 Claudin is a major structural component of tight junctions Gastric and (GEJ) adenocarcinoma Target patient population: and seals intercellular space in epithelial sheets Broadly expressed in various cancer types Prevalence of patients with high expression of Claudin 18.2 is substantial: 33% – 37% ~60% of primary pancreatic adenocarcinomas; approx. 20% of these meet the eligibility criteria for the ongoing Phase 2 studyHER2-, Claudin 18.2+ locally advanced and metastatic gastric and GEJ adenocarcinoma Metastatic gastric cancer is an area of significant unmet need, especially in advanced stages with ~4% five-year survival rate at Stage IV and limited treatment options have been limitedP3: SPOTLIGHT First line, Combo with mFOLFOX6, DB, vs. placebon=550Enrollment completed in Feb 2022P3: GLOWFirst line, Combo with CAPOX, DB, vs. placebon=500Enrollment completed in Feb 2022Gastric and GEJadenocarcinomaPancreatic adenocarcinomaP2P2: ILUSTROn=116FSFT: Sep 2018Cohort 1: Third or later line, zolbetuximab monotherapyCohort 2: First line, Combo with mFOLFOX6Cohort 3: Third or later line, Combo with pembrolizumabCohort 4: First line, Combo with mFOLFOX6 and nivolumabFirst line, Combo with nab-paclitaxel and gemcitabine, openn=369FSFT: May 2019GEJ: Gastroesophageal junction, HER2-: HER2 negative, Claudin 18.2+: Claudin 18.2 positive, mFOLFOX6: 5-FU, leucovorin and oxaliplatin, DB: Double-blind, CAPOX: Capecitabine and oxaliplatin, FSFT: First subject first treatmentFEZOLINETANT: NK3 RECEPTOR ANTAGONIST(Red: Updates since the last financial results announcement)50VMS has a significant negative impact on QoL Physical symptoms include hot flashes and night sweats, which can Women’s Health Initiative (WHI) Study 2 Initial data analyses showed an association between chronic HRT use and impact sleep. Physical symptoms may lead to emotional impact including embarrassment, irritability, anxiety, and sadness Symptoms have a negative impact on multiple aspects of everyday life 1increased risk of cardiovascular disease and breast cancer Since WHI’s findings, use of HRT has dropped Although subsequent analysis of the WHI data have demonstrated that HRT is safe and effective when initiated in the appropriate patient in the appropriate manner (i.e. right time, formulation, dose and duration), prescriptions have not rebounded, leaving some women with minimal options to satisfactorily manage their VMSUS and EUP3: SKYLIGHT 1Moderate to severe VMS associated with menopause;P3: SKYLIGHT 2The first 12 weeks: DB, 30 mg and 45 mg vs. placebo (1:1:1)The last 40 weeks: Active extension treatment period, 30 mg or 45 mgn=527n=501Primary endpoints met (12w DB period topline results).Obtained 52w dataPrimary endpoints met (12w DB period topline results).Obtained 52w dataP3: SKYLIGHT 4VMS associated with menopause; 52 weeks: DB, 30 mg and 45 mg vs. placebo (1:1:1)n=1,831 Obtained 52w data in Mar 2022P3b: DAYLIGHT24 weeks, DB, 45 mg vs. placebo (1:1)Moderate to severe VMS associated with menopause, unsuitable for HRT;n=440FSFT: Nov 2021Asia (except for Japan)P3: MOONLIGHT 1Moderate to severe VMS associated with menopause;The first 12 weeks: DB, 30 mg vs. placebo (1:1)The last 12 weeks: Active extension treatment period, 30 mgn=302Primary endpoints not met (12w DB period topline results)LSLV: Apr 2022P3: MOONLIGHT 3VMS associated with menopause; open label, 30 mg for 52 weeksn=150Enrollment completedJapanP2b: STARLIGHT Peri- and post-menopausal patients with mild to severe VMS;12 weeks: DB, 2 doses vs. placebo (1:1:1)n=135FSFT: Nov 20211: DelveInsight, Epidemiology Forecast, Jun 2018, 2: Data Source – IMS NPA (2000-2016), IMS NSP (2000-2016). (3 HTs and SSRI) NAMS 2015 Position Statement. VMS: Vasomotor symptoms, QoL: Quality of life, HRT: Hormone replacement therapy, DB: Double-blind , FSFT: First subject first treatment, LSLV: Last subject last visitAT132 (RESAMIRIGENE BILPARVOVEC): rAAV8-Des-hMTM151Characteristics of AT132 Lead program in the gene therapy pipeline of Audentes Therapeutics, acquired by Astellas in Jan 2020 Designed to deliver a functional copy of human MTM1 gene by AAV8 to transfect and express myotubularin in skeletal muscle cells Regulatory designations granted: RMAT, Rare Pediatric Disease, Fast Track, andOrphan Drug designations PRIME and Orphan Drug designationsX-linked myotubular myopathy (XLMTM) Rare neuromuscular disease with X-linked, loss of function mutations in MTM1 gene Approximately 1 in 40,000 to 50,000 newborn males Estimated 50% mortality by 18 months Up to 24 hours of invasive mechanical ventilation, 60% of patients require tracheostomy > 80% require gastrostomy tube placement Motor milestones substantially delayed No treatment available; supportive care onlyASPIRO(clinical study for registration in XLMTM patients)n=26Study put on clinical hold by FDA due to a serious adverse event.Investigation on the event ongoing(r)AAV: (recombinant) Adeno-associated virus, Des: Desmin promoter, hMTM1: Human myotubularin gene, RMAT: Regenerative Medicine Advanced Therapy, PRIME: PRIority Medicines, FDA: Food and Drug AdministrationON THE FOREFRONT OF HEALTHCARE CHANGE