アステラス製薬（4503） – Presentation Material for Information Meeting (Q3/FY2021)

Q3/FY2021 FINANCIAL RESULTSENDED DECEMBER 31, 2021Naoki OkamuraChief Strategy Officer and Chief Financial Officer, Chief Business OfficerAstellas Pharma Inc.February 2, 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 Astellas Pharma. 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.AGENDA3IIIQ3/FY2021 Consolidated Financial ResultsIIIIIIInitiatives for Sustainable GrowthQ3/FY2021 FINANCIAL RESULTS: OVERVIEW4Revenue increased 6% YoY and is in line with full-year forecastCore OP increased 8% YoY and is above full-year forecast Sales of XTANDI and Strategic products increased more than 20% YoY,in line with ambitious full-year forecast offsetting sales decrease due to termination of sales and distribution / transfer of products SG&A expenses are slightly above full-year forecast R&D expenses are on track Gain on divestiture of intangible assets*: 24.1 billion yenEstablished a new account, which includes gain on sale of rights of in-market products or pipeline assets Core basis profit is above full-year forecast Full basis: OP increased YoY and is above full-year forecast Severance expenses due to early retirement incentive program in Japan(Booked in Q3: 15.8 bil. yen)Applicant for early retirement program: 650 employeesStrategic products: XOSPATA, PADCEV, EVRENZO*Breakdown of Gain on divestiture of intangible assets: Transfer of products to Cheplapharm (12.3 billion yen), Transfer of pipeline asset (9.2 billion yen), Transfer of Bendamustine (2.0 billion yen), etc.Q3/FY2021 FINANCIAL RESULTS5Q3/FY20Q3/FY21ChangeFY21 FCST*ProgressFX impact1,323.075.0%+42.8 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 of intangible assetsCore operating profitOther incomeOther expenseOperating profitProfit before taxProfit940.9187.720.0%363.090.2272.8168.817.37.051.3159.5164.2132.9992.3194.119.6%406.4108.7297.7177.620.24.254.9169.4167.4132.5Change(%)+5.5%+3.4%+11.9%+20.5%+9.1%+5.2%+51.4+6.4-0.4 ppt+43.4+18.5+24.9+8.8+3.0+17.1%—-2.8+3.6+9.9+3.2-0.4541.075.1%242.073.4%+6.2%+1.9%-0.3%218.0216.0174.077.7%77.5%76.1%* Announced in Oct 2021-24.1+24.1203.7220.0+16.3+8.0%270.081.5%+15.4 bil. yenQ3/FY2021 FINANCIAL RESULTS: REVENUE6Revenue increase driven by growth of XTANDI and Strategic products, which offsets sales decrease due to termination of sales and distribution / transfer of productsQ3/FY20Q3/FY21ChangeChange (%)Revenue940.9 bil. yen992.3 bil. yen+51.4 bil. yen+5.5%Increase in XTANDI and Strategic productsXTANDI, XOSPATA, PADCEV, EVRENZO+83.6 bil. yen Returned sales of Lexiscan, negatively impacted by COVID-19 in Q1/FY20 +12.8 bil. yenTermination of sales and distribution / transfer of productsCelecox, Lipitor, Eligard-34.7 bil. yenStrategic products: XOSPATA, PADCEV, EVRENZOQ3/FY2021 FINANCIAL RESULTS: SALES OF MAIN PRODUCTSQ3/FY2021 Act and FY2021 FCST (billion yen)7 Global sales increased 20% YoY, in line with forecast In addition to US, sales expansion in EU following approval of M1 HSPC indication Strong growth continues in Japan and ChinaXOSPATAYoY: +8.1 (+46%) Global sales increased, almost in line with forecast,driven by growth mainly in US and EU Sales contribution from China newly launched in Apr. 2021 XTANDI411.625.714.62.1PADCEVEVRENZOmirabegron126.9YoY: +68.9 (+20%)Progress against FCST: 74%FY2021 FCST: 554.1Progress against FCST: 73%FY2021 FCST: 35.4YoY: +5.2 (+56%)Progress against FCST: 70%FY2021 FCST: 20.7YoY: +1.4 (+199%)Progress against FCST: 29%FY2021 FCST: 7.2YoY: +4.6 (+4%)Progress against FCST: 72%FY2021 FCST: 176.3 Revenue in US grew steadily, in line with forecast Launched in Japan in Nov. 2021 and initial uptake has been very strong thus far Sales in Japan are behind full-year forecast Launched in Established Markets from Sep. 2021 and initial uptake has been slower than forecast Global sales are behind full-year forecast In US, sales are behind forecast due to lower than expected US OAB market growth and increased pricing pressureM1: Metastatic, HSPC: Hormone-sensitive prostate cancer, PADCEV (US): Co-promotion revenue from Seagen, mirabegron (Product name: Betanis/Myrbetriq/BETMIGA), OAB: Overactive bladderQ3/FY2021 FINANCIAL RESULTS: COST ITEMS8SG&A expenses increased YoY and slightly above full-year FCSTR&D expenses increased YoY and in line with full-year FCSTCore basis: Main items for YoY and progress against FCST Decrease mainly due to changes in product mix FX impact on elimination of unrealized gain: +0.2 pptCost of sales% of revenueYoY: -0.4pptSG&A expensesYoY: +11.9%Progress against FCST: 75.1%R&D expensesYoY: +5.2%Progress against FCST: 73.4% SG&A excl. XTANDI US co-pro fee: +24.9 bil. yen (YoY +9.1%) FX impact (+16.5 bil. yen) Investment in Digital Transformation (Approx. +6.0 bil. yen) Increase in sales promotion expenses for new product launch readiness(Approx. +2.5 bil. yen) Global optimization of personnel aligned with transformation of product portfolio (Approx. -5.0 bil. yen) Increase in development cost of zolbetuximab and expanded investmentin iota Decrease in development cost of fezolinetant On track with full-year forecastCOMMERCIAL ORGANIZATION REFORMS9Aiming to maximize VALUE by pursuing optimal commercial organization to achieve CSP2021 goalsChanges in the product portfolioChanges in business environment• Shift to specialty products• Changes in contact methods due to spread of • Expansion of virtual engagement and digital COVID-19communication Establish commercial organization’s response to the new business environment Enhance Omni-Channel activities and shift to “product dedicated model” in Japan Reducing resources for mature products and focusing on Strategic products Decrease of approx. 1,000 personnel (Japan, Europe, U.S., China, South Korea, etc.) Annual costs reduction when completed to be approx. 18.0 billion yen(Cost reduction in FY2021 to be approx. 9.0 billion yen)Personnel: Subject to Works Council, consultative, and legal requirementsFY2021 FULL-YEAR OUTLOOK10 YoY Revenue increase is on track driven by XTANDI and Strategic products SG&A expenses are slightly above full-year FCST but aiming to control for the full year Thorough budget control on a quarter basis Starting to realize impact of global personnel optimization aligned with transformation of product portfolio R&D expenses are on track Booked “Gain on divestiture of intangible assets” in Q3/FY2021, not included into full-year forecast Transfer of pipeline asset (9.2 billion yen) Transfer of Bendamustine (2.0 billion yen) As a result, Core OP to exceed full-year forecast Full basis profit to slightly exceed full-year forecast, as with Core basis No changes have been made to FY2021 forecast for Revenue and OPStrategic products: XOSPATA, PADCEV, EVRENZO AGENDA11IIIQ3/FY2021 Consolidated Financial ResultsIIIIIIInitiatives for Sustainable GrowthXTANDI & STRATEGIC PRODUCTS: HIGHLIGHT (1/2)(Red: Updates since the last financial results announcement)12Key Events Expected in FY2021MilestoneProject / ProductIndication / Clinical studyRegulatorydecisionenzalutamide / XTANDI M1 hormone-sensitive prostate cancer (EU)enfortumab vedotin /PADCEVmUC, platinum and PD-1/L1 inhibitor pretreated (US a,b)Jul 2021mUC, cis-ineligible and who have previously received one or more therapy (US a) Jul 2021mUC, platinum and PD-1/L1 inhibitor pretreated (EU) AchievedApr 2021CHMP positive opinion received in Dec 2021*The EC decision-making process has been paused for additional CHMP questions related to severe skin reactions in a French compassionate access programRadically unresectable UC that has progressed after anti-cancer chemotherapy (JP c)Sep 2021roxadustat / EVRENZO Symptomatic anemia associated with CKD (EU)Aug 2021gilteritinib / XOSPATA R/R AML (China d)Regulatory submissionData readoutfezolinetant52-week safety results from Phase 3 SKYLIGHT 1, 2 &4 studiesJul 2021 (SKYLIGHT 2)Oct 2021 (SKYLIGHT 1)a: 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 approvalStrategic products: XOSPATA, PADCEV, zolbetuximab, EVRENZO, fezolinetant, AT132 M1: Metastatic, (m)UC: (metastatic) Urothelial cancer, CHMP: Committee for Medicinal Products for Human Use, EC: European Commission, CKD: Chronic kidney disease, R/R: Relapsed or refractory, AML: Acute myeloid leukemia, sBLA: Supplemental Biologics License Application, sNDA: Supplemental New Drug ApplicationXTANDI & STRATEGIC PRODUCTS: HIGHLIGHT (2/2)13Other Updates since the last financial results announcementProject / ProductIndicationUpdated statusenzalutamide / XTANDI M1 CSPCFiled label update to include the OS data in US and EU in Dec 2021gilteritinib / XOSPATAAML, post-HSCT maintenanceFiling timeline shifted to FY2023 due to slower-than-expected RFS events in Phase 3 MORPHO studyAML, newly diagnosed and HIC-ineligiblePhase 1 study in combo with venetoclax and azacitidine under preparation to start in Q1 FY2022enfortumab vedotin /PADCEVMuscle-invasive bladder cancerCohort H data in EV-103 study to be presented at ASCO GU in Feb 2022fezolinetantNon-muscle-invasive bladder cancerVMS associated with menopauseFSFT in Phase 1 study in Jan 2022LSLV in Phase 3 SKYLIGHT 4 study in Jan 2022FSFT in Phase 3b DAYLIGHT study in Nov 2021FSFT in Japan Phase 2b STARLIGHT study in Nov 2021Completed 12-week treatment a in Asia Phase 3 MOONLIGHT 1 study in Jan 2022a: Double-blind, placebo-controlled period followed by 12-week active treatment extension period:Strategic products: XOSPATA, PADCEV, zolbetuximab, EVRENZO, fezolinetant, AT132M1 CSPC: Metastatic castration-sensitive prostate cancer, OS: Overall survival, AML: Acute myeloid leukemia, HSCT: Hematopoietic stem cell transplant, RFS: Relapse-free survival, HIC: High-intensity chemotherapy, ASCO GU: American Society of Clinical Oncology Genitourinary Cancers Symposium, FSFT: First subject first treatment, VMS: Vasomotor symptoms,LSLV: Last subject last visitGILTERITINIB: DEVELOPMENT STATUS14New study in newly diagnosed and high intensity chemotherapy-ineligible AML to startPASHA (HOVON)FLT3 mut+AMLPrE0905 (PrECOG)High-intensity inductionchemoLow-intensity chemoP1 (triplet)Chemo consolidationTransplantMaintenanceGOSSAMERMaintenanceMORPHOADMIRALSalvage therapyLaunchedFiling timeline shifted to FY2023 due to slower-than-expected RFS eventsPhase 1 study in newly diagnosed and HIC-ineligible AML under preparation to start in Q1 FY2022TreatmentTriplet combination of gilteritinib/venetoclax/azacitidinePatient segment Newly diagnosed and HIC-ineligible FLT3 mutated AML (same as that in LACEWING study)Mechanistic rationaleExpected to lead to more efficient and complete eradication of both FLT3 and non-FLT3 mutated AML clonesRelevant clinical dataHigh morphologic and molecular responses and survival outcomes treated with triplet combo therapy of FLT3 inhibitor, venetoclax and HMA observed in 3 independent studies**CR >70% in all studies; 16.2% in LACEWING study (gilteritinib + azacitidine group) AML: Acute myeloid leukemia, FLT3 mut+: FLT3 mutation positive, HOVON: The Haemato Oncology Foundation for Adults in the Netherlands,RFS: Relapse-free survival, HIC: High-intensity chemotherapy, HMA: Hypomethylating agent, CR: Complete remission*63rd ASH Annual Meeting & Exposition Abstract 696 (2021), Blood Cancer J 11:25 (2021), Blood Cancer J. 11:104 (2021)PROGRESS IN FOCUS AREA APPROACH (1/3):CLINICAL PROOF AND EXPANSION OF KEY PLATFORMSPrimary Focuses have robust pipeline to newly build Post-PoC portfolio by end FY2025Modality15Primary FocusBiology/Modality/Technology 1FY21FY22-23FY24-25abcdGenetic 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) 3Blindness & RegenerationCell replacementCell replacement (UDC)Gene regulation (AAV)Gene regulation & mitochondrial biogenesisMitochondria BiologyMitochondrial stressMitochondrial transferPrimary Focus CandidatesImmune modulating/regulatory cellsTissue-specific immune regulationProtein degraderNo. of projects aiming PoCby end FY25CSP 2Status7Delay: 115Judge: 1(PoC not achieved: 1)Small moleculeAntibodyGeneCellOtherStage of the most advanced project in the categoryDiscovery/ PreclinicalPre-PoCPost-PoCUpdates from Q2 a. PoC timing shifted to beyond FY25 in a research projectb. PoC not achieved for ASP1948c. PoC timing shifteddue to delay inenrollment in clinical study for ASP7517d. ASP2138 entered clinical phase; PoC timing shifted based on the latest development plan351Total311. Not exhaustively listed. 2. Estimated based on standard development timelines, assuming 100% probability of success (at CSP2021 announcement).3. The first convertibleCAR program (with autologous cells) IND is planned for late FY2021.PoC: Proof of concept (key clinical data supporting a decision to initiate late-stage development), AAV: Adeno-associated virus, UDC: Universal donor cellPROGRESS IN FOCUS AREA APPROACH (2/3):CURRENT STATUS IN PRIMARY FOCUS(Red: Updates since the last financial results announcement)Primary FocusBiology/Modality/Technology 1ProjectCurrent status16Genetic 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)(other)Blindness & RegenerationCell replacementCell replacement (UDC)Gene regulation (AAV)Gene regulation & mitochondrial biogenesisMitochondria BiologyPrimary Focus CandidatesMitochondrial stressMitochondrial transferImmune modulating/regulatory cellsTissue-specific immune regulationProtein degraderAT132AT845ASPIRO study put on clinical hold by FDA in Sep 2021Completed dosing in the second dose cohort in Phase 1 studyInterim data in Phase 1 study to be presented at WORLDSymposium in Feb 2022ASP1948ASP1951ASP7517ASP0739ASP9801TerminatedPhase 1 study ongoingPhase 2 study in R/R AML and MDS ongoingFSFT in Phase 1 study in advanced solid tumors in Dec 2021FSFT in Phase 1 study in Jan 2022Phase 1 study ongoingASP2138Phase 1 study to start in Q1 FY2022ASP1570ASP7317FSFT in Phase 1 study in Nov 2021Screening and enrollment in Phase 1b study put on hold, due to a manufacturing delayASP1128ASP0367Enrollment discontinued in Phase 2a study, based on the interim analysis for futilityPhase 2/3 study in PMM ongoingPhase 1b study in DMD ongoingModalitySmall 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 (3/3):ASP213817The lead program of bispecific immune cell engager to enter clinical phase Characteristics of ASP2138 Bispecific antibody targeting Claudin 18.2 and CD3 Forms a synapse between Claudin 18.2 expressing cancer cells and CD3 positive T cells and kills cancer cells by cytotoxic effect Created through research collaboration with Xencor Positioned as a successor of zolbetuximab with expected higher efficacy Under preparation to initiate Phase 1 study in Q1 FY2022 Target disease: gastric and GEJ adenocarcinoma, pancreatic adenocarcinomaCD3positive T cellClaudin 18.2expressing cancer cellBind to T cells and cancer cellsKilling of cancer cellsAdministrationCytotoxic effectCD3Claudin 18.2ASP2138• Claudin 18.2 and CD3 binding sites• Format utilizing Xencor’s XmAb technologyGEJ: Gastroesophageal junctionPROGRESS IN Rx+ PROGRAM18Key events expected in FY2021 (announced in Apr 2021)Sphere * ProgramEventChronic disease progression preventionFit-eNceInitiation of pilot marketing for at-home service (Fit-eNce Home)Initiation of pilot marketingAchievedSep 2021Game application for exercise supportBlueStarMy Holter IIInitiation of clinical study (Japan)Commercialization of serviceJul 2021Topline results for Phase 2 studyNov 2021Patient outcome maximizationASP5354(pudexacianinium chloride)Topline results for Phase 2 study of ASP5354 Safety and efficacy support proceeding to Phase 3 study Study results will be announced at SAGES in March 2022* Business areas to focus on for realization of Rx+ StorySAGES: Society of American Gastrointestinal and Endoscopic SurgeonsPROGRESS TOWARD ACHIEVING CSP2021Revenue, Pipeline ValueCore OP191XTANDI and Strategic products: ≥ ¥1.2T in FY2025 Sales growth in line with ambitious forecast XTANDI: Filing label update to include OS data in US & EU XOSPATA: Initiating Phase 1 study of triplet combo therapy for newly diagnosed and HIC-ineligible AML PADCEV: CHMP positive opinion, presentation of MIBC data, FSFT in Phase 1 study for NMIBC fezolinetant: LSLV in SKYLIGHT 4 study, progress of clinical studies as planned Lexiscan (US): Settled patent infringement litigation against some defendants. Litigation ongoing against other defendants. Currently predict generic entry of Lexiscan within CSP2021 period5 Flat SG&A in absolute termsSufficient R&D investments Core OP margin of ≥ 30% in FY202567 Steady increase in dividends Investment for new product launch Thorough budget control on a quarter basis Starting to realize impact of global personnel optimization aligned with transformation of product portfolioFuture Growth8Rx+: Breakeven by FY20259 Sustainability ASP5354: Topline results obtainedPost-PoC projects from Primary Focuses3 Multiple technology platformsFocus Area projects:≥ ¥0.5T in FY203024 AT845: Dosing completion in Cohort 2 in Phase 2 study ASP7517 (solid tumors), ASP0739, ASP1570: FSFT in Phase 1 study ASP2138: Entry into clinical phaseStrategic products: XOSPATA, PADCEV, zolbetuximab, EVRENZO, fezolinetant, AT132CSP: Corporate Strategic Plan, OS: Overall survival, HIC: High-intensity chemotherapy, AML: Acute myeloid leukemia, CHMP: Committee for Medicinal Products for Human Use, MIBC: Muscle-invasive bladder cancer, NMIBC: Non-muscle-invasive bladder cancer, FSFT: First subject first treatment, LSLV: Last subject last visitSCHEDULE20Sustainability Meeting Feb 28th 2022, 15:00-16:30 (JST)R&D Meeting Mar 9th 2022, 9:30-11:00 (JST)- Initiatives for gene therapy -APPENDIXGAIN ON DIVESTITURE OF INTANGIBLE ASSETS22 P/L has a new account from Q3/FY2021: Gain on divestiture of intangible assets• This account includes gain on sale of rights of in-market products or pipeline assets from Q3 onwardIncluded this account as a core basis performance•• Upfront payment and royalty income from license agreements to be booked as RevenueP/L itemRevenueForm of transaction License-out of rights of in-market products or pipeline assets(The rights are owned by Astellas) Upfront payment, milestone and royalty income booked as RevenueAccountingGain on divestiture of intangible assets Transfer of rights of in-market products or pipeline assetsFollowings booked as Gain on divestiture of intangible assets Difference between upfront payment and book value of intangible assets Milestone and royalty incomeReference information: Gain on transfer of products to Cheplapharm (¥12.3 billion), gain on transfer of pipeline asset (¥9.2 billion), and gain on transfer of Bendamustine (¥2.0 billion), etc. were booked as Gain on divestiture of intangible assets in Q3/FY2021.Q3/FY2021: REVENUE BY REGION23(billion yen)Q3/FY20Q3/FY21Change (%)Japan221.8203.2-8.4%United States355.8407.9+14.7%Established Markets218.0239.2+9.8%Greater China50.3+14.8%International Markets83.0-5.3%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.43.887.6Q3/FY2021: SALES OF MAIN PRODUCTS24(billion yen)Q3/FY20 Q3/FY21ChangeCER growthFY21FCST*XTANDI342.7411.6+20.1%+14.4%554.1XOSPATA17.625.7+45.8%+39.0%PADCEVEVRENZO9.40.714.6+55.7%+49.0%2.1+198.6%+197.5%mirabegron122.3126.9+3.8%-0.3%Prograf138.3141.1+2.0%-3.5%35.420.77.2176.3185.7PADCEV (US): Co-promotion revenue from Seagenmirabegron (Product name: Betanis/Myrbetriq/BETMIGA)Prograf: Incl. Advagraf/Graceptor/ASTAGRAF XL*Announced revised forecast in Oct 2021Q3/FY2021 FINANCIAL RESULTS: BUSINESS UPDATE FOR MAIN PRODUCTS25XTANDI XOSPATAPADCEVEVRENZOGlobal sales increased steadily as expected given the ongoing focus on recent M1 HSPC launches and continuous strong growth is expected. In the US, demand grew +15% YoY. In Europe, reimbursement for M1 HSPC continues to expand to most major markets (Germany, UK, Spain, France, Netherlands, Switzerland, etc.) supporting growth YoY. Strong growth continues in Japan and ChinaSales across regions steadily expanded and global sales are in line with forecast. Initial sales trend is positive thus far in China – launched in Apr 2021 (Q3/FY21 sales: 1.3 billion yen).Recent approvals in International Markets (Russia, Saudi Arabia, Turkey) will contribute to the future growth of XOSPATARevenue in the US grew steadily as expected following approval of additional indication in Jul 2021.Further global launches occurred in Q3/FY21: Japan (Nov 2021), Switzerland (Dec 2021)Initial PADCEV uptake has been very strong thus far in Japan (Q3/FY21 sales: 0.5 billion yen)Overall sales performance is below expectations. Sales in Japan increased aligned with the expansion of the HIF-PHI class. However, sales have increased slower than expected due to increased competitive pressure. Following the EU approval and launches in Germany, UK, Netherlands, Austria, Nordics, etc. sales have begun to increase, though slower than anticipated given COVID-19 impact on launch executionmirabegronGlobal sales increased, driven by growth mainly in Japan and Established Markets, but behind full-year forecast. In the US, Myrbetriq sales against forecast are behind 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 Q3/FY2021 ACTUAL: FX RATE26Average rate for the periodQ3/FY20Q3/FY21Change106 yen122 yen111 yen131yen+5 yen+8 yenCurrencyUSDEURCurrencyUSDEURChange in closing rate from previous fiscal year endQ3/FY20Q3/FY21-5 yen+7 yen+4 yen+1 yen 42.8 billion yen increase in revenue, 15.4 billion yen increase in core OP FX impact on elimination of unrealized gain: COGs ratio +0.2 pptFY2021 FCST： FX RATE & FX SENSITIVITY27Exchange rate Average for the periodFY21Forecast110 yen130 yenForecast rates from Q3/FY2021 onward: 110 USD/yen, 130 EUR/yenEstimated FX sensitivity (Q3 onward) of FY2021 forecasts by 1 yen appreciation*Average rate1 yen higher than assumptionYear-end rate1 yen higher thanassumptionRevenueCore OPCore OPApprox. -6.4 bil. yenApprox. -0.8 bil. yen Approx. +0.6 bil. yenApprox. -2.8 bil. yenApprox. -1.0 bil. yen Approx. +0.3 bil. yenUSDEURCurrencyUSDEUR* Sensitivity to fluctuation of FX rates used for consolidation of overseas affiliates’ results compared to forecasted rates from Q3/FY2021 onwardBALANCE SHEET & CASH FLOW HIGHLIGHTS28(billion yen)Total assetsCash and cash equivalentsTotal equity attributable to owners of the parentEquity ratio (%)2,273.6326.11,386.161.0%FY20 endDec. 31, 2021(billion yen)Q3/FY20Q3/FY21FY20Cash flows from operating activitiesCash flows from investing activitiesFree cash flowsCash flows from financing activitiesBonds and short-term borrowingsProceeds from long-term borrowingsDividends paid225.1-67.7157.4-171.3-161.080.0-76.2208.9-47.6161.3-141.3-40.0–85.2Balance of bonds and borrowings：160.0 billion yen(Decreased by 40.0 billion yen from FY2020 end)2,356.2350.21,466.362.2%306.8-81.9224.9-229.5-206.080.0-76.2CAPITAL ALLOCATION291Top 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 forecastTrend of Core OP and dividendsDividends(yen)100806040200DividendsCore OP*1450YF1660YF22242525252627303234363840425070YF80YF90YF01YF11YF21YF31YF41YF51YF61YF71YF81YF91YF02YF12YF22YF32YF42YF52YFFor illustrative purposes only* Prior to FY2012, operating profit is in accordance with J-GAAPCSP: Corporate Strategic PlanCore OP(billion yen)6,0006005,0005004,0004003,0003002,0002001001,0000ROBUST PIPELINE OF ASTELLAS30Phase 1Phase 2Phase 3Filedenfortumab vedotin(mUC, pretreated: EU) 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)enfortumab vedotin(NMIBC)gilteritinib (Newly diagnosed AML, HIC-ineligible)ASP1951ASP9801ASP7517(Solid tumors)ASP0739ASP7317bocidelpar/ASP0367(Duchenne muscular dystrophy)AT845ASP0598ASP2390ASP1570ASP2138ASP8062(Alcohol use disorder)enfortumab vedotin(Other solid tumors)zolbetuximab(Pancreatic adenocarcinoma)roxadustat(Chemotherapy-induced anemia)resamirigene bilparvovec/AT132 (XLMTM)ASP7517(AML and MDS)ASP1128(Acute kidney injury)bocidelpar/ASP0367(Primary mitochondrial myopathies)ASP3772(Pneumococcal disease)FX-322(Sensorineural hearing loss)isavuconazole(Pediatric use: US)ASP8062(Opioid use disorder)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 diseaseThe listed compounds are investigational agents the safety and efficacy of which has not yet been established. There is no guarantee that the agents will receive regulatory approval or become commercially available for uses being investigatedNMIBC: 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 Announcement31Phase 1 EntryPhase 2 EntryPhase 3 EntryFilingApprovalgilteritinibNewly diagnosed AML, high-intensity chemotherapy-ineligibleASP2138gastric and GEJ adenocarcinoma, pancreatic adenocarcinomaDiscontinuationASP1948: Cancer (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 bodyIND: Investigational new drug, AML: Acute myeloid leukemia, GEJ: Gastroesophageal junction XTANDI & STRATEGIC PRODUCTS: STATUS UPDATE(Red: Updates since the last financial results announcement)32IndicationM1 CSPCM0 CSPCenzalutamide /XTANDIgilteritinib /XOSPATACurrent status• US & EU: Filed label update to include the OS data in Dec 2021• China: Phase 3 study ongoing (enrollment completed)• Phase 3 study ongoing (enrollment completed)Relapsed and refractory AML• China: Phase 3 study stopped due to efficacyAML, post-HSCT maintenance• Phase 3 study ongoing (enrollment completed); Filing timeline shifted to FY2023AML, newly diagnosed (HIC-eligible)• Phase 3 study ongoingAML, newly diagnosed (HIC-ineligible)• Phase 1 study in combo with venetoclax and azacitidine under preparation to start in Q1 FY2022AML, post-chemotherapy• Obtained topline results of Phase 2 GOSSAMER studyenfortumab vedotin / PADCEVMetastatic urothelial cancer• Pretreated: CHMP positive opinion received in Dec 2021• Previously untreated (first line): Phase 3 study ongoing• China: Phase 2 bridging study ongoingMuscle-invasive bladder cancer• Phase 3 studies ongoing• Cohort H data in EV-103 study to be presented at ASCO GU in Feb 2022Non-muscle-invasive bladder cancer• Phase 1 study ongoing (FSFT in Jan 2022)Other solid tumors• Phase 2 study ongoingzolbetuximabGastric & GEJ adenocarcinoma• Phase 3 studies ongoingPancreatic adenocarcinoma• Phase 2 study ongoingroxadustat /EVRENZOChemotherapy-induced anemia• Obtained topline results of Phase 2 studyfezolinetantVMS associated with menopause• US & EU: Obtained 52w data of Phase 3 pivotal studies, SKYLIGHT 1 and SKYLIGHT 2. Phase 3 long-term study (SKYLIGHT 4) ongoing (LSLV in Jan 2022). Phase 3b DAYLIGHT study ongoing (FSFT in Nov 2021)• Asia: Phase 3 pivotal study (MOONLIGHT 1) ongoing (completed 12w DB treatment in Jan 2022). Phase 3 long-term study (MOONLIGHT 3) ongoing (enrollment completed)• Japan: Phase 2b STARLIGHT study ongoing (FSFT in Nov 2021)AT132(resamirigene bilparvovec) X-linked myotubular myopathy• ASPIRO study put on clinical hold by FDA due to a serious adverse eventStrategic products: XOSPATA, PADCEV, zolbetuximab, EVRENZO, fezolinetant, AT132M1: Metastatic, M0: Non-metastatic, CSPC: Castration-sensitive prostate cancer, OS: Overall survival, AML: Acute myeloid leukemia, HSCT: Hematopoietic stem cell transplant, HIC: High-intensity chemotherapy, CHMP: Committee for Medicinal Products for Human Use, ASCO GU: American Society of Clinical Oncology Genitourinary Cancers Symposium, FSFT: First subject first treatment, GEJ: Gastroesophageal junction, VMS: Vasomotor symptoms, LSLV: Last subject last visit, DB: Double-blind, FDA: Food and Drug AdministrationENZALUTAMIDE (1/2): ANDROGEN RECEPTOR INHIBITOR33US/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. placebo n=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 2021P3: EMBARK M0 CSPC Combo with ADT, vs. placebo n=1,068 Enrollment completedChina • M1 CSPC: Enrollment completed in Phase 3 China-ARCHES studyRed: Updates since the last financial results announcementM1: Metastatic, M0: Non-metastatic, CSPC: Castration-sensitive prostate cancer, CRPC: Castration-resistant prostate cancer, ADT: Androgen deprivation therapy, OS: Overall survivalENZALUTAMIDE (2/2): PHASE 3 STUDY DATA BY DISEASE STAGE34Continued 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 INHIBITOR35FLT3 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)Newly diagnosed (HIC-ineligible)P3: PASHA (HOVON)P2: PrE0905 (PrECOG)P1Monotherapy vs. salvage chemo (2:1)Combo with high intensity chemo gilteritinib vs. midostaurin (1:1)Combo with venetoclax and azacitidinen=768FSFT: Dec 2019 (Sponsor: HOVON)n=179FSFT: Dec 2019 (Sponsor: PrECOG, LLC.)TBDTo start in Q1 FY2022Enrollment completedCollaborating with BMT-CTNPost-HSCT maintenanceP3: MORPHOMonotherapy vs. placebo (1:1) n=346Post-chemo maintenanceP2: GOSSAMERMonotherapy vs. placebo (2:1) n=98Obtained topline results in Aug 2021China • 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 analysisRed: Updates since the last financial results announcementFLT3 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, BMT-CTN: Blood and Marrow Transplant – Clinical Trial Network, R/R: Relapsed or refractoryENFORTUMAB VEDOTIN (EV) (1/3): NECTIN-4 TARGETED ADCOVERALL UC PROGRAM36Early stageNMIBCStages 0a-1- Disease stage of urothelial cancer -Late stageMIBCStages 2 and 3mUCStage 4PatienttreatmentBCG-unresponsiveRC-eligibleTargetEV 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) + RCPreviously untreated(first line)PD-1/L1 inhibitor pretreatedPlatinum and PD-1/L1 inhibitor pretreatedEV+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.Filed in EU, received CHMP positive opinionP2: EV-201(Cohort 1)Approved(AA) &launched in USP3: EV-301vs. ChemoP2: EV-203(Bridging studyin China)Red: Updates since the last financial results announcementADC: 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 Approval, CHMP: Committee for Medicinal Products for Human UseENFORTUMAB VEDOTIN (EV) (2/3):CLINICAL STUDIESFor urothelial cancerP3: EV-301P3: EV-302mUC, Platinum and PD-1/L1 inhibitor pretreated; EV mono vs. ChemomUC, Previously untreated, Platinum-eligible; EV + Pembro vs. ChemoP3: EV-303/KEYNOTE-905MIBC, Cis-ineligible; Pembro +/- EV (perioperative) + RC vs. RC aloneP3: EV-304/KEYNOTE-B15MIBC, Cis-eligible; EV+Pembro (perioperative) + RC vs. Chemo (neoadjuvant) + RCmUC, 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)P1b/2: EV-103Cohorts H, J and L (MIBC, Cis-ineligible, + RC):n=45737n=608sBLA (to convert regular approval) approved in US in Jul 2021. Approved in JP in Sep 2021. CHMP positive opinion received in Dec 2021n=860FSFT: Apr 2020n=836FSFT in Pembro + EV arm: Dec 2020n=784FSFT: May 2021Cohort 1: Approved (under the Accelerated Approval n=219program) and 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 USFor other solid tumorsmUC, Platinum and PD-1/L1 inhibitor pretreated; EV monon=40FSFT: Aug 2021NMIBC, High-risk BCG-unresponsive; Intravesical EV monon=58FSFT: Jan 2022HR+/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 2020P2: EV-201P2: EV-203P1: EV-104P2: EV-202Red: Updates since the last financial results announcementmUC: Metastatic urothelial cancer, mono: Monotherapy, Chemo: Chemotherapy, sBLA: Supplemental Biologics License Application, CHMP: Committee for Medicinal Products for Human Use,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) (3/3):STUDY DATA BY DISEASE STAGE OF UCEarly 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)38Late stageEV-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 responseZOLBETUXIMAB: ANTI-CLAUDIN 18.2 MONOCLONAL ANTIBODY39Target: Claudin 18.2 Claudin is a major structural component of tight Gastric and (GEJ) adenocarcinoma Target patient population: junctions 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=550FSFT: Oct 2018P3: GLOWFirst line, Combo with CAPOX, DB, vs. placebon=500FSFT: Jan 2019Gastric and GEJadenocarcinomaP2: ILUSTROPancreatic adenocarcinomaP2Cohort 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 nivolumabn=116FSFT: Sep 2018First 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 ANTAGONIST40VMS has a significant negative impact on QoL Physical symptoms include hot flashes and night sweats, which can 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 1US and EUWomen’s Health Initiative (WHI) Study 2 Initial data analyses showed an association between chronic HRT use and increased 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 VMSModerate to severe VMS associated with menopause;The 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 mgVMS associated with menopause; 52 weeks: DB, 30 mg and 45 mg vs. placebo (1:1:1)Moderate to severe VMS associated with menopause, unsuitable for HRT;24 weeks, DB, 45 mg vs. placebo (1:1)n=440FSFT: Nov 2021n=527n=501Primary endpoints met (12w DB period topline results).Obtained 52w dataPrimary endpoints met (12w DB period topline results).Obtained 52w datan=1,831LSLV: Jan 2022Moderate 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=302Completed 12w DB treatment in Jan 2022P3: MOONLIGHT 3VMS associated with menopause; open label, 30 mg for 52 weeksn=150Enrollment completedP2b: STARLIGHT Peri- and post-menopausal patients with mild to severe VMS;12 weeks: DB, 2 doses vs. placebo (1:1:1)n=135FSFT: Nov 2021Red Updates since the last financial results announcement1: 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, LSLV: Last subject last visit, FSFT: First subject first treatmentP3: SKYLIGHT 1P3: SKYLIGHT 2P3: SKYLIGHT 4P3b: DAYLIGHTAsia (except for Japan)P3: MOONLIGHT 1JapanON THE FOREFRONT OF HEALTHCARE CHANGE