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1、Committed to Long-term Growth&Shareholder Returns41stAnnual J.P.Morgan Healthcare ConferencePresident&CEOJanuary 9th,2023Christophe WeberFor the purposes of this notice,“presentation”means this document,any oral presentation,any question and answer session and any written or oral material discussed
2、or distributed by Takeda Pharmaceutical Company Limited(“Takeda”)regarding this presentation.This presentation(including any oral briefing and any question-and-answer in connection with it)is not intended to,and does not constitute,represent or form part of any offer,invitation or solicitation of an
3、y offer to purchase,otherwise acquire,subscribe for,exchange,sell or otherwise dispose of,any securities or the solicitation of any vote or approval in any jurisdiction.No shares or other securities are being offered to the public by means of this presentation.No offering of securities shall be made
4、 in the United States except pursuant to registration under the U.S.Securities Act of 1933,as amended,or an exemption therefrom.This presentation is being given(together with any further information which may be provided to the recipient)on the condition that it is for use by the recipient for infor
5、mation purposes only(and not for the evaluation of any investment,acquisition,disposal or any other transaction).Any failure to comply with these restrictions may constitute a violation of applicable securities laws.The companies in which Takeda directly and indirectly owns investments are separate
6、entities.In this presentation,“Takeda”is sometimes used for convenience where references are made to Takeda and its subsidiaries in general.Likewise,the words“we”,“us”and“our”are also used to refer to subsidiaries in general or to those who work for them.These expressions are alsoused where no usefu
7、l purpose is served by identifying the particular company or companies.The product names appearing in this document are trademarks or registered trademarks owned by Takeda,or their respective owners.Forward-Looking StatementsThis presentation and any materials distributed in connection with this pre
8、sentation may contain forward-looking statements,beliefs or opinions regarding Takedas future business,future position and results of operations,including estimates,forecasts,targets and plans for Takeda.Without limitation,forward-looking statements often include words such as“targets”,“plans”,“beli
9、eves”,“hopes”,“continues”,“expects”,“aims”,“intends”,“ensures”,“will”,“may”,“should”,“would”,“could”,“anticipates”,“estimates”,“projects”or similar expressions or the negative thereof.These forward-looking statementsare based on assumptions about many important factors,including the following,which
10、could cause actual results to differ materially from those expressed or implied by the forward-looking statements:the economic circumstances surrounding Takedas global business,including general economic conditions in Japan and the United States;competitive pressures and developments;changes to appl
11、icable laws and regulations,including global health care reforms;challenges inherent in new product development,including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof;uncertainty of commercial success for new and existing products;manufacturing diffi
12、culties or delays;fluctuations in interest and currency exchange rates;claims or concerns regarding the safety or efficacy of marketed products or product candidates;the impact of health crises,like the novel coronavirus pandemic,on Takeda and its customers and suppliers,including foreign government
13、s in countries in which Takeda operates,or on other facets of its business;the timing and impact of post-merger integration efforts with acquired companies;the ability to divest assets that are not core to Takedas operations and the timing of any such divestment(s);the extent to which our internal e
14、nergy conservation measures and future advancements in renewable energy or low carbon energy technology will enable us to reduce our greenhouse gas emissions;and other factors identified in Takedas most recent Annual Report on Form 20-F and Takedas other reports filed with the U.S.Securities and Exc
15、hange Commission,available on Takedas website at:https:/ at www.sec.gov.Takeda does not undertake to update any of the forward-looking statements contained in this presentation or any other forward-looking statements it may make,except as required by law or stock exchange rule.Past performance is no
16、t an indicator of future results and the results or statements of Takeda in this presentation may not be indicative of,and are not an estimate,forecast,guarantee or projection of Takedas future results.Financial Information and Certain Non-IFRS Financial MeasuresTakedas financial statements are prep
17、ared in accordance with International Financial Reporting Standards(“IFRS”).This presentation and materials distributed in connection with this presentation include certain financial measures not presented in accordance with IFRS,such as Core Revenue,Core Operating Profit,Core Net Profit,Core EPS,an
18、d Constant Exchange Rate(“CER”)change.Takedas management evaluates results and makes operating and investment decisions using both IFRSand non-IFRS measures included in this presentation.These non-IFRS measures exclude certain income,cost and cash flow items which are included in,or are calculated d
19、ifferently from,the most closely comparable measures presentedin accordance with IFRS.By including these non-IFRS measures,management intends to provide investors with additional information to further analyze Takedas performance and core results,including when controlling for the effect of fluctuat
20、ions in exchange rates.Takedas non-IFRS measures are not prepared in accordance with IFRS and such non-IFRS measures should be considered a supplement to,and not a substitute for,measures prepared in accordance with IFRS(which we sometimes refer to as“reported”measures).Investors are encouraged to r
21、eview the definitions and reconciliations of non-IFRS financial measures to their most directly comparable IFRS measures,which are in the financial appendix appearing at the end of this presentation.Exchange Rates In this presentation,certain amounts presented in Japanese yen have been translated to
22、 US dollars solely for the convenienceof the reader.The rate and methodologies used for these convenience translations differ from the currency exchange rates and translation methodologies under IFRS used for the preparation of Takedas consolidated financial statements.These translations should not
23、be construed as a representation that the relevant Japanese yen amounts could be converted into U.S.dollars at this or any other rate.Medical informationThis presentation contains information about products that may not be available in all countries,or may be available under different trademarks,for
24、 different indications,in different dosages,or in different strengths.Nothing contained herein should be considered a solicitation,promotion or advertisement for any prescription drugs including the ones under development.Important Notice2Better Health for People,Brighter Future for the WorldWe stri
25、ve to transform Takeda into the most trusted,science-driven,digital biopharmaceutical companyPATIENT Responsibly translatescience into highly innovative,life-changing medicines and vaccinesPEOPLE Create an exceptional people experience PLANET Protect our planetOur vision is to discover and deliver l
26、ife-transforming treatments,guided by our commitment to:We are guided by our values of Takeda-ism which incorporate Integrity,Fairness,Honesty,and Perseverance,with Integrity at the core.They are brought to life through actions based on Patient-Trust-Reputation-Business,in that order.Accelerate acce
27、ss to improve lives worldwide A N D B Y U N L E A S H I N G T H E P O W E R O F D ATA A N D D I G I TA L31.Please refer to appendix slide 15 for definition of core financial measures and slides 16-19 for reconciliation.2.Constant Exchange Rate.Please refer to appendix slide 15 for definition.3.Forec
28、ast in USD given for reference using full-year FX rate assumption of 132.4 JPY/USD.This reflects H1 at actual FX and applies the Apr-Oct 2022 average rate to H2 projections.Growth&Launch Products Driving Topline&Profit GrowthCore RevenueFY2022 MANAGEMENT GUIDANCEGROWTH AT CER2CORE REVENUELow-single-
29、digit growth CORE OPERATING PROFITHigh-single-digit growthCORE EPSHigh-single-digit growth4Strong FY2022 H1 PerformanceOn Track to Full-year FY2022 Guidance+5.5%at CER1,2Growth&Launch Products+19%at CER1,2Core Operating Profit Margin31.7%Core EPS+15.8%at CER1,2RevenueJPY 3,930B(USD$29.7B)3Core EPS52
30、5 yen(USD$3.97)3represent 38%of total revenueGrowth&Launch Products Revenue Grew+19%at CER in FY22 H1GIRARE DISEASES PLASMA-DERIVED THERAPIES(PDT)IMMUNOLOGYONCOLOGYNEUROSCIENCEOTHERGROWTH&LAUNCH PRODUCTS OTHER KEYPRODUCTSAzilva(JP)IMMUNOGLOBULINALBUMINNuvaxovid1.Convenience translation at an exchang
31、e rate of 1USD=144.71 JPY,the Noon Buying Rate certified by the Federal Reserve Bank of New York on September 30,2022.Total FY2022 H1 Revenue 759.8B(USD 5.3B)1(+19%growth at CER)+17%+31%+17%+33%+8%New Launch+41%New LaunchAll growth rates indicate FY2022 H1 revenue growth at CER5Takecab/VocintiGattex
32、/RevestiveAdvate/AdynoviVonvendiVprivElapraseReplagal(EU,JP)GlassiaAralastNinlaroAdcetris(ex-N.America)IclusigLeuprorelinZejula(JP)Cabometyx(JP)VyvanseTrintellix(US,JP)(JP)(JP)Peak Sales Estimate Raised to USD$7.5-9.0B Gut-selective alpha4beta7 integrin antagonist#1 prescribed biologic in IBD bio-na
33、ve patients in the U.S.1 Head-to-head superiority versus adalimumab in UC2 9 yrs of patient experience supports favorable safety profile Strong uptake of SC formulation in Europe&Canada Revised assumption on biosimilar entry timing High unmet patient need remains in IBD Biologics market continues to
34、 expand globally ENTYVIO total patient share still increasing SC formulation regulatory filing in U.S.expected in FY2023 Continuing to invest in further evidence generation1.Source:US:SHA Medical and Pharmacy Claims data,June 20222.Sands BE,Peyrin-Biroulet L,Loftus EV,et al.Vedolizumab versus adalim
35、umab for moderate to severe ulcerative colitis.N Engl J Med.2019;381(13):12151226.3.Forecast in USD given for reference using full-year FY2022 FX rate assumption of 132.4 JPY/USD4.Source:US:SHA Medical and Pharmacy Claims data,June 2022;EUCAN:Internal estimate;Japan:Japan Medical Data Center,June 20
36、22ENTYVIO REVENUE%OF PATIENTS RECEIVING ENTYVIO400500600700800FY15FY20FY14FY16FY18FY17FY21FY19FY22(Forecast3)JPY 721.0BUSD$5.4B BN JPY6Outstanding Growth MomentumRaised Peak Sales Reflect Growth OpportunityPDT Portfolio Revenue Growth of+10-20%at CER Expected in FY22Driven by Strong Deman
37、d and Stable SupplyFY2021FY2018FY2022(projection)CAGR+11%+10-20%PDT IMMUNOLOGY REVENUE GROWTH(CER)Fastest and strongest post-pandemic recovery of donation volumes in the industry On track to increase plasma supply and manufacturing capacity 65%by end FY20231 Dedicated R&D organization focused on max
38、imizing potential of PDT Positive Phase 3 data for HyQvia in CIDP Improving efficiencies across the entire value chain to improve profitability Reduced donor compensation by 15%in H1 FY2022 versus same period in prior yearCAPACITY EXPANSIONR&D INVESTMENTMARGIN IMPROVEMENT71.Versus calendar year 2018
39、 baselineIMMUNOGLOBULIN REVENUE GROWTH(CER)FY2018FY2021FY2022(projection)CAGR+11%+10-20%ALBUMIN REVENUE GROWTH(CER)FY2018FY2021FY2022(projection)CAGR+14%+10-20%Enhancement of PDT operations is driving double-digit annual revenue growth for key PDT productsStrong Pipeline Progression Since FY22 Q281.
40、N Engl J Med 2022;387:2356-2361,N Engl J Med 2022;387:2391-23922.HSCT:hematopoietic stem cell transplantation;Press release: full glossary of abbreviations please refer to appendix.ASSETMILESTONENEXT STEPSQDENGATAK-003 Approved in EU and Indonesia,and positive CHMP opinion for dengue-endemic countri
41、es that participated in EMA EU-M4all procedureLaunch in Indonesia,EuropeSeek additional approvals:US and endemic countriesICLUSIG ponatinib1L Ph+ALL positive phase 3 PhALLCONtrialData from this trial will be discussed with regulatory agencies and shared with the scientific communityTAK-755Phase 3 tr
42、ial interim analysis in cTTP:Favorable efficacy and safety profile versus standard of care U.S.filing expected in FY22 cTTP:2 case reports published in NEJM1LIVTENCITY maribavir1L CMV infection in HSCT2phase 3 AURORA trial confirmed favorable safety and showed evidence of durable anti-viral efficacy
43、 Engaging regulatory agencies about filing strategy 12wk./16wk./20wk.data favorable for LIVTENCITY Favorable safety profile with lower incidence of neutropenia Did not achieve non-inferiority at 8 wk.1 endpointfazirsiranTAK-999AATD-LD positive phase 2b SEQUOIA trialPhase 3 start expected in FY22TAK-
44、861Met prespecified criteria to advance to Phase 2 Phase 2b on-track to start in January 2023ONCOLOGYRARE GENETICS&HEMATOLOGYNEURO-SCIENCEVACCINESGASTRO-ENTEROLOGYApproved in Indonesia&EU for Prevention of Dengue Disease Against All Serotypes,Regardless of Prior Dengue Exposure First approval in Ind
45、onesia in Aug 2022 for individuals 6-45 years of age Approved in EU in Dec 2022 for individuals 4 years of age and older,and positive CHMP opinion recommending use in dengue-endemic countries that participated in the EMA EU-M4all procedure Regulatory reviews progressing in dengue-endemic countries i
46、n Latin America&Asia Granted priority review by U.S.FDA in November 2022 Pivotal study in 20,000 children and adolescents in Latin America&Asia 80.2%reduction in symptomatic dengue 12 months(primary endpoint);90.4%reduction in hospitalizations 18 months(key secondary endpoint)Continued protection th
47、rough 4.5 years(exploratory analyses):61%reduction in symptomatic dengue and 84%reduction in hospitalizations No important safety risks identified2Significant prevention of hospitalizations,an important factor for dengue fever management1Two approvals in 2022 and continuing regulatory progress aroun
48、d the world1.Tricou,V.Efficacy and Safety of Takedas Tetravalent Dengue Vaccine Candidate(TAK-003)After 4.5 Years of Follow-Up.Presented at the 8th Northern European Conference of Travel Medicine;June 2022.2.Most common adverse events were injection-site pruritus,bruising,and pyrexiaEMA:European Med
49、icines Agency9Cumulative Incidence of Participants With HospitalisedVirologically Confirmed Dengue,%84%reduction of hospitalized casesTakeda to Acquire Late-Stage,Potential Best-in-Class,Oral Allosteric TYK2 Inhibitor NDI-034858 from Nimbus Therapeutics1 NDI-034858 is a novel,investigational,oral,al
50、losteric inhibitor of tyrosine kinase 2(TYK2)with high specificity for TYK2 over JAK1,JAK2,JAK3 kinases Source:Gangolli,et al.2022.Characterization of pharmacokinetics,pharmacodynamics,tolerability and clinical activity in Phase 1 studies of the novel allosteric tyrosine kinase 2(TYK2)inhibitor NDI-
51、034858.1.Transaction is expected toclose before the end of FY2022,contingent on completion of review under antitrust lawsSource:Nimbus proprietary structure based computational modeling;side-by-side evaluation of biochemical potency of NDI-034858 and deucravacitinib(synthesized by Nimbus for nonclin
52、ical research purposes only).Potential for enhanced efficacy without introducing JAK-related toxicities10High Selectivity Allows for Greater Inhibition of TYK2Potential for Best-in-Class Profile Potential to demonstrate best-in-class efficacy,safety and convenience in multiple immune-mediated diseas
53、es,including psoriasis,Inflammatory Bowel Disease,psoriatic arthritis and lupus Phase 3 psoriasis study expected to start in 2023;potential for regulatory filing in FY25-27Committed to Long-term Growth&Shareholder ReturnsNear-term(FY2022-2023)Continued expansion of Growth&Launch Products Late-stage
54、pipeline launches Limited LOE exposure until Entyvio biosimilars launch Growth&Launch Products expected to mitigate near-term Loss of Exclusivities(e.g.VELCADE&VYVANSE)Additional contribution from clinical pipeline of 40 NMEs Robust research engineContinued Pipeline Enhancement Supported by a Solid
55、Financial FoundationMedium-term(FY2024-early 2030s)Long-term(FY2030s and beyond)11Q&AANDY PLUMPDirector;President,Research&DevelopmentCOSTA SAROUKOSDirector;Chief Financial OfficerCHRISTOPHE WEBERRepresentative Director;President&CEOJULIE KIM President,US Business UnitTERESA BITETTIPresident,Global
56、Oncology Business UnitAPPENDIXAny biosimilar that seeks to launch prior to 2032 would need to address potential infringement and/or the validity of all relevant patentsBiosimilar clinical trials expected to take 3-4+yearsRegulatory review(1 year)Clinical development timeline2023202420252026202720282
57、029203020312032Legal proceedingsPotential scenario in the U.S.should patents be challenged in biosimilar litigationTakeda has granted patents that cover various aspects of Entyvio,including formulation,dosing regimens and process for manufacturing.These patents are expected to expire in 2032 in the
58、U.S.In the U.S.,the biosimilar litigation process is triggered by FDA acceptance of a relevant aBLAIn general,biosimilar litigation proceedings in the U.S.may take 3-5 yearsPre-litigationprocessEntyvio is only approved in IBD indications,for which clinical trials are typically longer and more challe
59、nging to complete than other auto-immune diseases which we have recently observed biosimilar manufacturers targetCompetitive Intelligence suggests Ph1 activity starting with biosimilar companies in China and Iran.However,no vedolizumab biosimilar Phase 1 clinical trial starts targeting the U.S.,EU,o
60、r Japan markets has been publicly disclosed so far.14Definition of Core Financial Measures and Constant Exchange Rate changeCoreRevenuerepresents revenue adjusted to exclude significant items unrelated to Takedascore operations.Core OperatingProfitrepresents net profit adjusted to exclude income tax
61、 expenses,the share of profit or loss of investmentsaccounted for using the equity method,finance expenses and income,other operating expenses and income,amortization andimpairmentlosses on acquired intangibleassets andother items unrelated to Takedascore operations,such as non-recurringitems,purcha
62、se accounting effects and transaction related costs.Core EPSrepresents net profit adjusted to exclude the impact of items excluded in the calculation of Core Operating Profit,andother non-operatingitems(e.g.amongstother items,fair value adjustments and the imputed financial charge related to conting
63、entconsideration)that are unusual,non-recurring in nature or unrelated to Takedasongoing operations and the tax effect of each ofthe adjustments,divided by theaverage outstanding shares(excluding treasury shares)of the reporting periods presented.CER(ConstantExchangeRate)changeeliminates the effect
64、of foreign exchange rates from year-over-yearcomparisons bytranslating Reported or Core results for the current period using corresponding exchangerates in the sameperiod of theprevious fiscal year.15FY2022 H1 Reported Results with Actual and CER%Change16*1 Please refer to page 15 definition of Core
65、 Financial Measures and Constant Exchange Rate change for the definition.Note:%change versus prior year is presented as positive when favorable to profits,and negative when unfavorable to profits.FY2022 H1 Core Results with Actual and CER%Change17*1 Please refer to page 15 definition of Core Financi
66、al Measures and Constant Exchange Rate change for the definition.Note:%change versus prior year is presented as positive when favorable to profits,and negative when unfavorable to profits.FY2022 H1 Reconciliationfrom Reportedto Core18FY2021 H1 Reconciliationfrom Reportedto Core*1 Taxchargesof63.7 bi
67、llionJPYarisingfromthetaxassessment involvingIrishtaxationofthe breakfeeShirereceivedfromAbbVieinconnectionwiththeterminatedoffertoacquireShiremadebyAbbViein2014,netof0.5billionJPY ofassociatedtax benefit.19AATD-LD1-antitrypsin deficiency associated liver diseaseADCantibody drug conjugateADHDattenti
68、on deficit hyperactivity disorderAHAacquired hemophilia AALKanaplastic lymphoma kinaseALCLanaplastic large-cell lymphomaALLacute lymphocytic leukemiaAMLacute myeloid leukemiaASCTautologous stem cell transplantARDacid-related diseasesAVAAdvanced Vial AccessBBBblood brain barrierBLAbiologics license a
69、pplicationBMAbradykinin mediated angioedemaBTDbreakthrough therapy designationCAR-Tchimeric antigen receptor-TCDCrohns diseaseCHMPCommittee for Medicinal Products for Human UseCIDPchronic inflammatory demyelinating polyradiculoneuropathyCLLchronic lymphocytic leukemiaCMLchronic myeloid leukemiaCMVcy
70、tomegalovirusCNScentral nervous systemCPFcomplex perianal fistulasCRLcomplete response letterCRPCCastrate-resistant prostate cancerCTCLcutaneous T-cell lymphomacTTPcongenital thrombotic thrombocytopenic purpuraDEEdevelopmental and epileptic encephalopathiesDLBCLdiffuse large B-cell lymphomaDOACdirec
71、t oral anti-coagulationDSDravet syndromeDUduodenal ulcerDxDiagnosisEE Herosive esophagitis healingEE Merosive esophagitis maintenanceEGFRepidermal growth factor receptorEMAEuropean Medicines AgencyFDAthe U.S.Food&Drug AdministrationFLfront lineFSIfirst subject inFYfiscal yearGERDgastroesophageal ref
72、lux diseaseGIgastrointestinalGUgastric ulcerGvHDgraft versus host diseaseHAEhereditary angioedemaH2Hhead-to-headHemAhemophilia AHLHodgkin lymphomaHSCThematopoietic stem cell transplantIBDinflammatory bowel diseaseIgANimmunoglobulin A nephropathy IHidiopathic hypersomniaINCATInflammatory Neuropathy C
73、ause and Treatment disability scoreINDinvestigational new drugiNHLindolent non-Hodgkins lymphomaITPImmune thrombocytopenic purpuraiTTPimmune thrombotic thrombocytopenic purpuraIVintravenousiPSCinduced pluripotent stem cellsL-ASAlow dose aspirinLSDlysosomal storage disorderLCMlifecycle managementLGSL
74、ennox-Gastaut syndromemAbmonoclonal antibodyMAOBmonoamine oxidase BMDDmajor depressive disorderMGmyasthenia gravisMLDmetachromatic leukodystrophyMMmultiple myelomaMMNmultifocal motor neuropathyNBENew Biological EntityNCENew Chemical EntityNDnewly diagnosedNDAnew drug applicationNegNegativeNERDnon-er
75、osive reflux diseaseNHLnon-Hodgkin lymphomaNKnatural killerNMEnew molecular entityNMPANational Medical Products AdministrationNSCLCnon-small cell lung cancerNSCTnon stem cell transplantNT1 or 2narcolepsy Type 1 or 2ORRoverall response rateOSAobstructive sleep apneaPARPpoly(ADP-ribose)polymerasePASpr
76、ior approval supplementPCABpotassium competitive acid blockerPCDprotein C deficiencyPEXplasma exchangePh+ALLPhiladelphia chromosome-positive acute lymphoblastic leukemiaPIDprimary immunodeficiencyRegional Abbreviations:CN:China;EU:Europe;JP:Japan;US:United States of AmericaPKpharmacokineticsPMDAJapa
77、ns Pharmaceuticals and Medical Devices AgencyPOCproof of conceptPOGDpost-operative gastrointestinal dysfunctionPONVpostoperative nausea and vomitingPRIMEPriority medicines scheme by EMAPTCLperipheral T-cell lymphomaPTHparathyroid hormoneR/Rrelapsed/refractoryRCCrenal cell cancerRTKreceptor tyrosine
78、kinaseRTUready to use sALCLsystemic anaplastic large cell lymphomaSBSshort bowel syndromeSCsubcutaneous formulationSCDsickle cell diseaseSCTstem cell transplantSIDsecondary immunodeficiencySLEsystemic lupus erythematosussqsquamousSTINGstimulator of interferon genesSUMOsmall ubiquitin-related modifie
79、rTCET-cell engagerTESDtreatment emergent sexual dysfunctionTKItyrosine kinase inhibitorTREM2triggering receptor expressed on myeloid cells 2UCulcerative colitisVCD virologically confirmed denguevWDvon Willebrand diseaseVWFvon Willebrand factorGLOSSARY OF ABBREVIATIONS20 2023 Takeda Pharmaceutical Company Limited.All rights reserved.