《阿斯利康AstraZeneca(AZN)2023年第一季度財報「LSE」(英文版)(41頁).pdf》由會員分享,可在線閱讀,更多相關《阿斯利康AstraZeneca(AZN)2023年第一季度財報「LSE」(英文版)(41頁).pdf(41頁珍藏版)》請在三個皮匠報告上搜索。
1、Q1 2023 ResultsConference call and webcast for investors and analysts27 April 2023 Forward-looking statements2In order,among other things,to utilise the safe harbour provisions of the US Private Securities Litigation Reform Act of 1995,AstraZeneca(hereafter the Group)provides the following cautionar
2、y statement:This document contains certain forward-looking statements with respect to the operations,performance and financial condition of the Group,including,among other things,statements about expected revenues,margins,earnings per share or other financial or other measures.Although the Group bel
3、ieves its expectations are based on reasonable assumptions,any forward-looking statements,by their very nature,involve risks and uncertainties and may be influenced by factors that could cause actual outcomes and results to be materially different from those predicted.The forward-looking statements
4、reflect knowledge and information available at the date of preparation of this document and the Group undertakes no obligation to update these forward-looking statements.The Group identifies the forward-looking statements by using the words anticipates,believes,expects,intends and similar expression
5、s in such statements.Important factors that could cause actual results to differ materially from those contained in forward-looking statements,certain of which are beyond the Groups control,include,among other things:the risk of failure to meet regulatory or ethical requirements for medicine develop
6、ment or approval;the risk of failures or delays in the quality or execution of the Groups commercial strategies;the risk of pricing,affordability,access and competitive pressures;the risk of failure to maintain supply of compliant,quality medicines;the risk of illegal trade in the Groups medicines;t
7、he impact of reliance on third-party goods and services;the risk of failure in information technology or cybersecurity;the risk of failure of critical processes;the risk of failure to collect and manage data in line with legal and regulatory requirements and strategic objectives;the risk of failure
8、to attract,develop,engage and retain a diverse,talented and capable workforce;the risk of failure to meet regulatory or ethical expectations on environmental impact,including climate change;the risk of the safety and efficacy of marketed medicines being questioned;the risk of adverse outcome of liti
9、gation and/or governmental investigations;intellectual property-related risks to our products;the risk of failure to achieve strategic plans or meet targets or expectations;the risk of failure in financial control or the occurrence of fraud;the risk of unexpected deterioration in the Groups financia
10、l position;the impact that global and/or geopolitical events such as the COVID-19 pandemic and the Russia-Ukraine war may have or continue to have on these risks,on the Groups ability to continue to mitigate these risks,and on the Groups operations,financial results or financial condition.Nothing in
11、 this document,or any related presentation/webcast,should be construed as a profit forecast.3Q1 2023 resultsConference call agendaCEO Opening RemarksPascal SoriotChief Executive OfficerFinancial ResultsAradhana SarinChief Financial OfficerOncologyDave FredricksonEVP,Oncology BusinessSusan GalbraithE
12、VP,Oncology R&DBioPharmaceuticalsRuud DobberEVP,BioPharmaceuticals BusinessMene PangalosEVP,BioPharmaceuticals R&DRare DiseaseMarc DunoyerChief Executive Officer,AlexionCEO Closing Remarks,Q&APascal SoriotChief Executive OfficerCEO Opening RemarksPascal SoriotCHIEF EXECUTIVE OFFICER5Q1 2023 15%growt
13、h from ex-COVID-19 medicines1Stable Total Revenue,reiterating FY 2023 guidanceReiterating 2023 guidance:Core EPS to increase by a high single-digit to low double-digit%Financial ResultsOncologyBioPharmaceuticalsRare DiseaseCEO Opening RemarksCEO Closing RemarksGrowth in Oncology,CVRM,R&I and Rare Di
14、sease offset decline in COVID-19 medicinesAll growth rates at CER.1.Vaxzevria,Evusheld and AZD3152;CER=constant exchange rates;EPS=earnings per share.Total Revenue|stable CERQ1 2022Q1 2023$1.92Core EPS|+6%CER$10.9bnQ1 2022Q1 2023Ex-COVID-19 Total Revenue+15%Vaxzevria/Evusheld Total Revenue6Q1 2023 b
15、road-based,diverse source of businessFinancial ResultsOncologyBioPharmaceuticalsRare DiseaseCEO Opening RemarksCEO Closing RemarksAll growth rates in CER.CVRM=Cardiovascular,Renal&Metabolism;R&I=Respiratory&Immunology;V&I=Vaccines&Immune Therapies;ERoW=Established Rest of World.Industry-leading outl
16、ook underpinned by broad portfolio and geographic footprintOncology 38%CVRM 24%R&I 15%V&I 3%Rare Disease 17%Other 3%Q1 2023|%Total Revenue by therapy areaUS40%Emerging Markets29%Europe 20%ERoW 12%Q1 2023|%Total Revenue by geographyStrong growth across Oncology,CVRM,R&I and Rare DiseaseEmerging Marke
17、ts presence and strong growthValue-enhancing business development strengthening growing pipelineIncreasing pipeline momentum71.Phase III trial initiation defined as achievement of first patient dosed;2.AVANZAR and TROPION-Lung07 Phase III first patient dosed ahead of Q4/FY 2022 results on 09 Februar
18、y 2023.NSCLC=non-small cell lung cancer;1L=first-line(metastatic);EoE=eosinophilic esophagitis;HR+/HER2-=hormone receptor-positive/human epidermal growth factor receptor-negative;BC=breast cancer;CSA-AKI=cardiac surgery-associated acute kidney injury.Collaboration partners:Daiichi Sankyo(Dato-DXd),A
19、mgen(Tezspire).Accelerating our late-stage pipelineFinancial ResultsOncologyBioPharmaceuticalsRare DiseaseCEO Opening RemarksCEO Closing RemarksPotential to initiate 30 Phase III trials,with six dosed to-date in 2023110 potential blockbuster opportunities from 30 Phase III trials planned in 2023Dato
20、-DXdDato-DXdTezspireAZD3152camizestrantUltomirisAVANZAR21L NSCLCTROPION-Lung072non-squamous 1L NSCLCCROSSINGEoESUPERNOVACOVID-19 prophylaxis CAMBRIA-1HR+/HER2-adjuvant BCARTEMISCSA-AKIPotential HLR:2024Potential HLR:2024Potential HLR:2024Potential HLR:H2 2023 Potential HLR:2024Potential HLR:2024Fina
21、ncialResultsAradhana SarinCHIEF FINANCIAL OFFICER9Absolute values at actual exchange rates;changes at CER.Gross margin excludes the impact of Alliance and Collaboration Revenue and any associated costs,thereby reflecting the underlying performance of Product Sales.1.Total operating expenses include
22、distribution,R&D and SG&A expenses.R&D=Research&Development;SG&A=Sales,General&Administrative;pp=percentage points;CER=constant exchange rates.Q1 2023 Reported profit and lossFinancial ResultsOncologyBioPharmaceuticalsRare DiseaseCEO Opening RemarksCEO Closing RemarksQ1 2023$mCER change%TotalRevenue
23、Total Revenue10,879-100-Product Sales10,566197-Alliance Revenue286903-Collaboration Revenue27(89)-Gross margin82.0%+14 ppTotal operating expense1(6,804)-63-R&D expense(2,611)2824-SG&A expense(4,059)(13)37Other operating income and expense37933Operating profit2,5492x23Tax rate20.2%Reported EPS$1.164x
24、10Absolute values at actual exchange rates;changes at CER.Gross margin excludes the impact of Alliance and Collaboration Revenue and any associated costs,thereby reflecting the underlying performance of Product Sales.1.Total operating expenses include distribution,R&D and SG&A expenses.R&D=Research&
25、Development;SG&A=Sales,General&Administrative;pp=percentage points;CER=constant exchange rates.Q1 2023 Core profit and lossFinancial ResultsOncologyBioPharmaceuticalsRare DiseaseCEO Opening RemarksCEO Closing RemarksQ1 2023$mCER change%TotalRevenueTotal Revenue10,879-100-Product Sales10,566197-Allia
26、nce Revenue286903-Collaboration Revenue27(89)-Gross margin 83.3%+4 ppTotal operating expense1(5,488)950-R&D expense(2,300)1021-SG&A expense(3,054)828Other operating income and expense3183x3Operating profit3,946436Tax rate20%Core EPS$1.92622.93.10.22.03.00.125.1111.Comprises disposal of intangible as
27、sets,movement in profit participation liability,purchase of intangible assets,payment of contingent consideration on business combinations,purchase and disposal of non-current asset investments,payment of Acerta Pharma share purchase liability and acquisitions of subsidiaries,net of cash acquired.2.
28、EBITDA adding back the impact of$2,340m 12-month rolling period(FY 2022:$3,484m)unwind of inventory fair value uplift recognised on acquisition of Alexion.AstraZeneca credit ratings:Moodys:short-term rating P-2,long-term rating A3,outlook stable.S&P Global Ratings:short-term rating A-1,long-term rat
29、ing A,outlook stable.3.Assuming average March 2023 foreign exchange rates for April to December 2023.EBITDA=earnings before interest,tax,depreciation and amortisation;CFO=net cash inflow from operating activities;EPS=earnings per share.Cash Flow,Net Debt and 2023 Financial GuidanceContinued EBITDA i
30、mprovement$bnNet debt end 2022CFOCapexDeal payments and receipts1DividendOtherNet debt end March 2023Net Debt bridgeA low single-digit adverse FX-impact anticipated for both Total Revenue and Core EPS in 20233Financial ResultsOncologyBioPharmaceuticalsRare DiseaseCEO Opening RemarksCEO Closing Remar
31、ks$12.7bn$13.4bnAdjusted EBITDA2BIBPNet Debt/EBITDA:2.3xNet Debt/EBITDA adjusted for Alexion inventory fair value uplift:1.9xReiterating 2023 GuidanceTotal RevenueExcluding COVID-19 medicines:low double-digit%growthIncluding COVID-19 medicines:low-to-mid single-digit%growthCore EPSHigh single-digit
32、to low double-digit%12Artificial Intelligence at AstraZenecaLeadership in AI is transforming the way we work and pace of innovationFinancial ResultsOncologyBioPharmaceuticalsRare DiseaseCEO Opening RemarksCEO Closing RemarksAI=artificial intelligence;R&D=Research&Development;HCP=healthcare practitio
33、ners.Strategic investment in AI and digital tools has delivered demonstrable productivity gains and improvements in science-led innovationDrug discovery and development Clinical trials Supportive internal tools and platformsRegulatory submission and monitoring Clinical forecasting and automation Pha
34、rmacovigilance Manufacturing and supply Digital supply chain and manufacturingCommercial launch and patient outcomes HCP experience Patient assistance Patient outcomesAI is embedded across our organisation400+data scientists employedR&D OPERATIONS COMMERCIAL 100+active AI projects within R&D aloneOn
35、cologyDave FredricksonONCOLOGY BUSINESSSusan GalbraithONCOLOGY R&D14CER=constant exchange rates;CN=China;PS=Product Sales;DB03=DESTINY-Breast03;MCL=mantle cell lymphoma.Collaboration partners:Daiichi Sankyo(Enhertu),Merck&Co.,Inc.(Lynparza).Oncology Q1 2023 19%Total Revenue growth driven by differen
36、tiated portfolio and new indication launchesFinancial ResultsOncologyBioPharmaceuticalsRare DiseaseCEO Opening RemarksCEO Closing RemarksEnhertu revenues 3x vs.Q4 2021,driven by continued HER2low bolus Tagrisso+15%CER,driven by global demand growth,CN recovery Lynparza PS+10%CER,strong PROpel EU upt
37、ake offset by flattening testing rates and destocking in US Imfinzi/Imjudo+56%CER,driven by global launch acceleration(TOPAZ-1,HIMALAYA,POSEIDON)Calquence+31%CER,strong EU growth offset by destocking in US following maleate tablet approval(Q3 2022)Enhertu 3x CER,strong global launch momentum New ind
38、ications:EU(Calquence maleate tablet,Imfinzi HIMALAYA,POSEIDON),CN(Calquence for MCL,Enhertu DB03)OncologyQ1 2023$4.1bn,+19%at CERTagrisso Imfinzi/Imjudo Calquence Enhertu Lynparza(PS)Lynparza milestones OthersQ1 2023:key dynamics05001,0001,5002,0002,5003,0003,5004,0004,500Q2Q3Q4Q1Q2Q3Q4Q12021202220
39、23Total Revenue($m)15Est epi(G7)=estimated epidemiology across G7(US,EU5,JP);Stg.=stage;CTx=chemotherapy;SBRT=stereotactic body radiation therapy;CRT=chemoradiotherapy;pembro=pembrolizumab;IO=immunotherapy;ADC=antibody-drug conjugate;PD1=programmed cell death protein 1;EGFR=epidermal growth factor r
40、eceptor;c-MET=mesenchymal-epithelial transition factor;TIGIT=T-cell immunoreceptor with immunoglobulin and ITIM domains;CTLA4=cytotoxic T-lymphocyte associated protein 4;TIM3=T-cell immunoglobulin and mucin domain-containing protein 3;SoC=standard of care;TKI=tyrosine kinase inhibitor.Collaboration
41、partners:Daiichi Sankyo(Enhertu,Dato-DXd),Compugen(rilvegostomig).OncologyAmbition for 50%of lung cancer patients to be eligible for AZN medicine by 2030Financial ResultsOncologyBioPharmaceuticalsRare DiseaseCEO Opening RemarksCEO Closing RemarksEGFRmc.16%IO sensitivec.70%Stg.I-IIImetastatic1L2L+Est
42、.epi(G7)200K30K70K350K290KHER2c.2%Other tumor drivers c.12%Imfinzi w/SBRTPACIFIC-4CRT+Imfinzi PACIFIC-2Imfinzi combos PACIFIC-8,-9 improvements across PD-L1 spectrumStg.I-IIStg.IIIunresectableCRT TagrissoLAURAImfinzi AEGEANvolrustomig+CTxNEOCOAST-2EnhertuDESTINY-Lung04Dato-DXd+IOImfinzi+Imjudo+CTxPO
43、SEIDONresectableDato-DXdTROPION-Lung01TROPION-Lung05AZD9592(EGFR/cMET ADC)EGRETDato-DXdTROPION-Lung01Imfinzi+ceralasertibLATIFYsavolitinib+TagrissoSAFFRON/SAVANNAHTagrisso+CTxFLAURA2CRT Imfinzi PACIFICTagrisso FLAURALeading the future of lung cancer treatmentTagrisso established TKI backbone in EGFR
44、mImfinzi leading IO in unresectable Advancing best-in-class ADCs to replace systemic chemotherapyDelivering next-wave bispecificsto improve on PD1/PD-L1Developing novel combinations,including IO+ADCInvesting behind new technologies and platforms,including cell therapy,testing/screeningAZD9592(EGFR/c
45、MET ADC)EGRETEnhertu+IODESTINY-Lung03Tagrissoneo-ADAURATagrissoADAURACRT Imfinzi PACIFICestablished SoCTROPION-Lung08TROPION-Lung07AVANZARTROPION-Lung04/02rilvegostomig(PD1/TIGIT)ARTEMIDE-1volrustomig(PD1/CTLA4)sabestomig(PD1/TIM3)EnhertuDESTINY-Lung0216Heymach JV et al.American Association for Canc
46、er Research Annual Meeting 2023.Abstract#CT005;Herbst RS et al.Journal of Clinical Oncology 2023 41:10,1830-1840AACR=American Association for Cancer Research annual meeting;pCR=pathologic complete response;(m)EFS=(median)event-free survival;OS=overall survival;NSCLC=non-small cell lung cancer;EGFRm=
47、epidermal growth factor receptor-mutated;CI=confidence interval;pbo=placebo;mo.=months;NR=not reached;HR=hazard ratio;(m)DFS=(median)disease-free survival;no.=number.Oncology R&D highlightsMoving into earlier lines of lung cancer with highest potential for cureFinancial ResultsOncologyBioPharmaceuti
48、calsRare DiseaseCEO Opening RemarksCEO Closing RemarksADAURA:final OSadjuvant Tagrisso in early stage EGFRm NSCLCFirst Phase III trial to demonstrate survival benefit in this settingTime from randomisation(months)Probability of DFS1.000.80.60.40.20.06121872666054484236302490%85%73%55%44%38%No.at ris
49、kTagrisso339316307289278270249201139733350placebo34328823020518116213711584482540Tagrisso(n=339)placebo(n=343)mDFS,mo.65.828.1HR(95%CI)0.27(0.210.34)Previously presented updated DFS in overall population(ESMO 2022)AEGEAN:updated pCR and interim EFSImfinzi-based treatment before and after surgery in
50、early-stage NSCLCPotential to become a backbone combination approach that may alter the course of a patients cancerImfinzi(n=366)placebo(n=374)mEFS,mo.NR25.9HR(95%CI)0.68(0.530.88);p=0.003917.24.30102030Imfinzi(n=366)placebo(n=374)difference=13.0%(95%CI:8.717.6)Time from randomisation(months)1.00pro
51、bability of EFS0.80.60.40.20.048423630241812673%65%63%52%36637427125714013678744950302511131100ImfinziplaceboNo.at riskASCO plenarypCR rate(%)171.Designed by AstraZeneca and manufactured and developed in China by Cellular Biomedicine group.AACR=American Association for Cancer Research annual meeting
52、;RECIST=Response Evaluation Criteria In Solid Tumours;CAR-T=chimeric antigen receptor T-cell;SLD=sum of longest diameters;GPC3=Glypican 3;CDX=cell line-derived xenograft;PDX=patient-derived xenograft;ADC=antibody-drug conjugate;EGFR=epidermal growth factor receptor;c-MET=mesenchymal-epithelial trans
53、ition factor;TOP1i=topoisomerase 1 inhibitor;FR=folate receptor alpha;MTAP=methylthioadenosine phosphorylase;SDMA=symmetric dimethylarginine;KO=knockout;IC50=half-maximal inhibitory concentration;nM=nanomolar.Oncology R&D highlightsAACR demonstrates harnessing of in-house capabilities to build early
54、-stage pipelineFinancial ResultsOncologyBioPharmaceuticalsRare DiseaseCEO Opening RemarksCEO Closing RemarksFirst clinical data for CAR-T therapyPreclinical data for three AstraZeneca in-house developed ADCsAZD9592AZD5335AZD8205EGFRcMETTOP1iFRFRTOP1iB7H4B7H4TOP1iMore detail available in AACR Investo
55、r BrochureUntreatedUntransduced 5e6 CellsUnarmoured 5e6 CellsAZD0754 5e6 cells3/10CR10/10CRControl AZD0754C-CAR031(armoured GPC3)1First-in-human trial in patients with hepatocellular carcinomaWell-tolerated with promising anti-tumour activity including objective responses in several patientsAZD0754(
56、armoured STEAP2)Favourable in vitro propertiesRobust dose dependent in vivo efficacy in STEAP2-expressing CDX and PDX modelsEncouraging preclinical safetyFirst disclosure and preclinical data for epigenetics molecule targeting PRMT5,AZ-PRMT5iAZ-PRMT5iCell SDMA MTAP KO IC50:5 nMMTAP selectivity:54-fo
57、ld-100-60-202040-40-800Best tumour shrinkage(per RECIST v1.1,n=6)Bestchangeoftumour SLD(%)Progressive diseaseStable diseasePartial responseTumour volume in mice after CAR-T injection0500750100012500602502040Tumour volume(mm3)Days post CAR-T InjectionHistone modificationRNA interferenceDNA methylatio
58、nBioPharmaceuticalsRuud DobberBIOPHARMACEUTICALS BUSINESSMene PangalosBIOPHARMACEUTICALS R&DCVRMQ1 2023$2.6bn,+22%at CERR&IQ1 2023$1.6bn,+8%at CERV&IQ1 2023$355m,-79%at CER191.COVID-19 mAbs=Evusheld and AZD3152,the antibody currently in developmentCER=constant exchange rates;R&I=Respiratory and Immu
59、nology;CVRM=Cardiovascular,Renal and Metabolism;V&I=Vaccine and Immune Therapies.Collaboration partners:Amgen(Tezspire);Sanofi(Beyfortus).BioPharmaceuticals Q1 2023Increasing momentum across CVRM and R&IFarxiga+39%to$1.3bnStrong double-digit growth from Lokelma and roxadustatCOVID-19 medicines decli
60、ned by$1.5bn Synagis+5%Fasenra+13%to$338mBreztri+73%to$144mTezspire+32%QoQ growth to$54mFinancial ResultsOncologyBioPharmaceuticalsRare DiseaseCEO Opening RemarksCEO Closing RemarksFarxiga Brilinta Lokelma OthersSymbicort Pulmicort Fasenra Breztri Tezspire Saphnelo OthersCOVID-19 mAbs1Vaxzevria Syna
61、gis Flumist Beyfortus05001,0001,5002,0002,500Q2Q3Q4Q1Q2Q3Q4Q1202120222023Total Revenue($m)02004006008001,0001,2001,4001,6001,800Q2Q3Q4Q1Q2Q3Q4Q1202120222023Total Revenue($m)05001,0001,5002,0002,5003,000Q2Q3Q4Q1Q2Q3Q4Q1202120222023Total Revenue($m)20BioPharmaceuticals Q1 2023Key medicines driving R&I
62、 growthFinancial ResultsOncologyBioPharmaceuticalsRare DiseaseCEO Opening RemarksCEO Closing Remarks260308338Q12021Q12021Q120230354Q12021Q12021Q12023TezspireSaphneloFasenra01147Q12021Q12021Q120232787144Q12021Q12021Q12023BreztriBuilding launch momentum in R&IR&I Q1 2023 Total Revenue Q1 2023$1.6bn+46
63、%growth in Q1 from key R&I medicinesFasenra Tezspire Saphnelo Breztri2022202220222022Total Revenue($m)Total Revenue($m)Total Revenue($m)Total Revenue($m)R&I=respiratory and immunology.Collaboration partners:Amgen(Tezspire).211.Populations relate to T7(US,EU5 and CN)and reflect AstraZeneca projection
64、s from IQVIA prescription and units sold dataICS=inhaled corticosteroid;SABA=short-acting beta-agonist;LABA=long-acting beta-agonist;LAMA=long-acting muscarinic antagonist;MPO=myeloperoxidase;TSLP=thymic stromal lymphopoietin;IL-33=interleukin-33;IL-5=interleukin-5;JAK=janus kinase;IL-4 Ra=interleuk
65、in-4 receptor alpha;FLAP=5-lipoxygenase-activating protein.Collaboration partners:Amgen(Tezspire).BioPharmaceuticals R&D highlightsLeading respiratory portfolio across asthma and COPDAsthmaCOPDtozorakimab(IL-33)Phase II data:H1 2023elarekibep(IL-4 Ra antagonist)Phase IIa data:2024AZD8630(inhaled TSL
66、P)Phase Iatuliflapon(FLAP inhibitor)Phase II data:2024mitiperstat(oral MPO inhibitor)Phase IIa data:2024Breztri(ICS/LABA/LAMA)Phase III data:2024Bevespi(LABA/LAMA)Airsupra(ICS/SABA)launchedapproved/launch prepPhase IIIPhase IIInhaled maintenance therapy Novel oral/inhaled add-onsNovel systemic biolo
67、gicsSymbicort(ICS/LABA)Breztri(ICS/LABA/LAMA)Symbicort(ICS/LABA)AZD4604(inhaled JAK)Phase IPhase IFasenra(IL-5)TezspireTSLP17m patients18.7m patients11.6m patients135m patients16m patients12m patients1Fasenra(IL-5)eosinophilictozorakimab(IL-33)Phase III data:2024Tezspire(TSLP)Phase IIa data:2024Fase
68、nra(IL-5)Phase III data:2024Novel oralInhaled biologic Novel inhaledNoveloralOther novel inhaled/oralsPhase I22SE=standard error;LSM=least squares mean;CI=confidence interval;ATTR-PN=transthyretin amyloidosis-polyneuropathy;TTR=transthyretin;mNIS+7=Modified Neuropathy Impairment Score+7.346.3-point
69、composite measure used to assess neurological impairment;Norfolk Qol DN=Norfolk Quality of Life-Diabetic Neuropathy;IC50=half-maximal inhibitory concentration;mAb=monoclonal antibody.Collaboration:eplontersen(Ionis)BioPharmaceuticals R&D highlightsCongress highlights at AAN and ECCMIDFinancial Resul
70、tsOncologyBioPharmaceuticalsRare DiseaseCEO Opening RemarksCEO Closing RemarksMet co-primary endpoints,with favourable safety and tolerability profileIn vitro studies show neutralisation across all known variants,including Arcturuseplontersen in ATTRv-PNNEURO-TTRansform Phase III final analysis(66 w
71、k)AZD3152long-acting COVID-19 antibody6535066350Weeks-14.5%-81.2%8.2-3.623AI in R&DAccelerating the time to deliver clinical leadsFinancial ResultsOncologyBioPharmaceuticalsRare DiseaseCEO Opening RemarksCEO Closing RemarksAI=Artificial Intelligence.DRUG DISCOVERY&DEVELOPMENT|reinventing the traditi
72、onal drug discovery process Knowledge graphs|empowering data insightsAccelerating discovery speed|small and large moleculesVisual representation of relationships built from data,external literature,etc.Which genes are upregulated in Disease A?What genes are linked to Disease A?Which targets are drug
73、gable?What are the pathway relationships between these targets?AI-enabled process cut time to identify target antibody leads to 3 days173high-quality antibody leads identified in 3 daysTraditional process generated 0 leads over 3 monthsAI-enabled process accelerates generation of high-quality small
74、molecules by 2xGenerative model:proposes new chemical matterScoring function:evaluates proposed moleculesRare DiseaseMarc DunoyerCHIEF EXECUTIVE OFFICER,ALEXION251.Includes Kanuma and Koselugo.2.Q3 2021 Total Revenues reported only comprise of those booked by AstraZeneca following completion of the
75、acquisition of Alexion on 21 July 2021.C5=C5 inhibitors Ultomiris and Soliris;CER=constant exchange rates;NMOSD=neuromyelitis optica spectrum disorder.Collaboration partners:Merck&Co.,Inc.(Koselugo).Rare Disease Q1 2023Accelerated conversion in C5,continued strength beyond complementQ1 2023:key dyna
76、micsDurable C5 Franchise growthUltomiris+61%driven by successful conversion from Soliris,new patients and market expansionSoliris(13%)decline reflecting successful conversion,partially offset by NMOSD growthRare DiseaseQ1 2023$1.9bn,+14%at CERFinancial ResultsOncologyBioPharmaceuticalsRare DiseaseCE
77、O Opening RemarksCEO Closing RemarksUltomiris Soliris Strensiq Others1Strong commercial execution across indications and geographies Strensiq+28%and Koselugo 2x Reflecting strength of patient demand and geographic expansion02004006008001,0001,2001,4001,6001,8002,000Q2Q3Q4Q1Q2Q3Q4Q1202120222023Total
78、Revenue($m)226Rare Disease R&D highlightsPioneering in rare neurology to improve patient outcomesFinancial ResultsOncologyBioPharmaceuticalsRare DiseaseCEO Opening RemarksCEO Closing Remarksgefurulimab(ALXN1720)pipeline expansion to further extend C5 leadershipPotential best-in-class weekly,self-adm
79、in s.c.in Phase Icomplete terminal complement inhibition2gefurulimab(ALXN1720)-C5-AlbPhase III PREVAIL in gMG:R1:1gefurulimab QW s.c.placebon=254MG-ADL total scoresPrimary endpoint:change from baseline inat Week 2675%patients on low-dose OCS after 1 yearC5 bi-specific,heavy chain(VHH)antibody demons
80、trated1.Pulley et al.American Academy of Neurology Annual Meeting 2023 based on Soliris data;concomitant therapies include:use of azathioprine(AZA),mycophenolate mofetil(MMF),intravenous immunoglobulin(IVIg)/plasma exchange(PLEX)and oral corticosteroids at initiation of,and during Soliris.2.Ortiz et
81、 al.American Academy of Neurology Annual Meeting 2023.Complete terminal complement inhibition is defined as serum-free C5 concentrations less than 0.5 micrograms per millilitre;gMG=generalised myasthenia gravis;mo.=month;mg=milligram;OCS=oral corticosteroids;VHH=single domain;Alb=albumin;r=randomise
82、d;QW=once weekly;s.c.=subcutaneous;MG-ADL=Myasthenia Gravis-Activities of Daily Living.Soliris gMG registry1oral corticosteroid usage decreased over time0-5mg5-10mg10-20mg20-30mg30mg0 mo.3 mo.6 mo.9 mo.12 mo.12 mo.%patients using oral corticosteroidsFactor D more likely to maintain consistent contro
83、l than Factor B inhibitorsFactor D inhibitionmore tractable target,lower circulating concentration in plasma 27Rare Disease R&DIndustry-leading Factor D portfolio Financial ResultsOncologyBioPharmaceuticalsRare DiseaseCEO Opening RemarksCEO Closing Remarks1.based on human protein concentrations in t
84、he plasma.2.Based on in vitro data.TID=three times per day;BID=two times per day;QD=once daily;PNH-EVH=paroxysmal nocturnal haemoglobinuria with clinically significant extravascular haemolysis;GA=geographic atrophy;gMG=generalised myasthenia gravis;LN=lupus nephritis;IgAN=immunoglobulin A nephropath
85、y.Factor D portfolionovel small molecule assets with high affinity for Factor DRobust Factor D portfolio with broad applicationdanicopan(ALXN2040)TIDPNH-EVHsubmitted,Phase II GAongoing as potential first oral treatmentvemircopan(ALXN2050)BIDPhase II ongoingPNH monotherapy,gMG,Renal(LN,IgAN)QDALXN208
86、0enteredPhase I in Q3 2022 with potential application in non-rare indicationsdosing development status2.15MFactor B1Factor D10.08 MFactor D inhibitionblocks alternative pathway,leaving classical and lectin pathways intactCEO Closing RemarksPascal SoriotCHIEF EXECUTIVE OFFICER291.Indicates Company am
87、bition to achieve Total Revenue low double-digit CAGR through 2025(2021 base year,Alexion pro-forma)and industry-leading Total Revenue beyond 2025;this is not formal guidance.Dato-DXd=datopotamabderuxtecan;NSCLC=non-small cell lung cancer;HER2=human epidermal growth factor receptor 2;HR=hormone rece
88、ptor;BC=breast cancer;EGFRm=epidermal growth factor receptor mutant;EGPA=eosinophilic granulomatosis with polyangiitis;ESG=environmental,sustainability and governance;CAGR=compound annual growth rate;NMEs=new molecular entities.Collaboration partners:Daiichi Sankyo(Enhertu,Dato-DXd).AstraZeneca Q1 2
89、023 Accelerating pipeline momentum,disciplined investment fuels industry-leading growthFinancial ResultsOncologyBioPharmaceuticalsRare DiseaseCEO Opening RemarksCEO Closing RemarksPipeline advances in 2023with 18 Phase III read-outs anticipated,including:H1 2023 H2 2023 Dato-DXd TROPION-Lung01 2nd-l
90、ine/3rd-line NSCLCTagrisso FLAURA2 1st-line NSCLCEnhertu DESTINY-Breast06 2L+HR-positive/HER2-low BCTagrisso LAURA Stage III unresectable EGFRm NSCLCFasenra MANDARA EGPA Ambition to improve operating margin Sustainable,long-term growththrough commercial execution,R&D impact and ESGDato-DXd TROPION-B
91、reast01 HR-positive/HER2-negative mBCTotal Revenue ambition1:low double-digit%2021-2025 Industry-leading growth 2025+At least 15 NMEs approved by 2030Emissions reduction:98%by end 2025 Scope 1&250%by 2030 Scope 3Remain focused on operating margin expansion30Question&Answer SessionPascal SoriotEXECUT
92、IVE DIRECTOR&CHIEF EXECUTIVE OFFICERMarc DunoyerCHIEF EXECUTIVE OFFICER,ALEXIONAradhana SarinEXECUTIVE DIRECTOR&CHIEF FINANCIAL OFFICERSusan GalbraithEXECUTIVE VICE PRESIDENT,ONCOLOGY R&DDave FredricksonEXECUTIVE VICE PRESIDENT,ONCOLOGY BUSINESSMene PangalosEXECUTIVE VICE PRESIDENT,BIOPHARMACEUTICAL
93、S R&DRuud DobberEXECUTIVE VICE PRESIDENT,BIOPHARMACEUTICALS BUSINESSIskra ReicEXECUTIVE VICE PRESIDENT,VACCINES AND IMMUNE THERAPIESLeon WangEXECUTIVE VICE PRESIDENT,INTERNATIONALAppendix Pipeline Highlights since Q4/FY2022 results ESG&Corporate Sustainability Oncology landscapes:breast and lung Eme
94、rging Markets Key Performance by Therapy Area32HER2+=Human epidermal growth factor receptor 2-positive;CHMP=Committee for Medicinal Products for Human Use.Collaboration partners:Daiichi Sankyo(Enhertu).Delivering on science-led innovationSelected key pipeline highlights since Q4/FY 2022 results Onco
95、logy BioPharmaceuticals Rare DiseaseAPPENDIX|Pipeline Highlights5 regulatory approvals in major markets,including:non-small cell lung cancer(1st-line)(POSEIDON)Imfinzi+/-Imjudo(EU)hepatocellular carcinoma(1st-line)(HIMALAYA)Imfinzi+Imjudo(EU)mantle cell lymphomaCalquence(CN)HER2+breast cancer(2nd-li
96、ne)(DESTINY-Breast03)Enhertu(CN)maleate tablet formulationCalquence(EU)1 positive CHMP opinion:neuromyelitis optica spectrum disorder(CHAMPION-NMO)Ultomiris(EU)331.Healthcare worker and others trained target=170,000 healthcare workers(cumulative)to strengthen health systems throughout the world thro
97、ugh our Healthy Heart Africa,Healthy Lung and Phakamisa programmes.SMI=Sustainable Markets Initiative.Access to HealthcareEnvironmental protectionEthics and transparency14public and private sector organisationsconvened by AstraZeneca CEO through the SMI to accelerate transition to net-zero health sy
98、stems126,684healthcare workers and others trained1(cumulative)59.3%reduction in Scope 1 and Scope 2 greenhouse gas emissions49.5%senior middle management roles held by women87%of employee survey respondents say that they understand their contributions to our sustainability priorities44.63mpeople rea
99、ched through Access to Healthcare programmes(cumulative)18.7%reduction in our water use8 countrieswith supplier diversity programmes25/27of sustainability targets in Sustainability Data Summary are on plan12.83mpeople reached through our patientassistance programmes(cumulative)18.6%reduction in our
100、waste83%of employee survey respondents feel we have a speak up cultureProgress on our overall strategy includes:By 2025:170,000By 2025:50MBy 2026:98%from 2015 base yearBy 2025:20%below 2015 baselineBy 2025:10%below 2015 baselineBy 2025:reach gender equality in management positionsBy 2025:10 new coun
101、tries outside of the USAPPENDIX|ESG&Corporate Sustainability2022 Sustainability highlights34Growth at CERCER=constant exchange rates;EM=Emerging Markets.Emerging Markets Q1 2023Total Revenue+1%at CER to$3.2bn.+22%at CER excluding COVID-19 medicinesAPPENDIX|Emerging Markets05001,0001,5002,0002,5003,0
102、003,5004,000Q2Q3Q4Q1Q2Q3Q4Q1202120222023Total Revenue($m)ChinaEmerging Markets ex.ChinaCOVID-19 medicinesTagrisso15%growth at CER to$1,424mImfinzi56%growth at CER to$900m35CER=constant exchange rates;EM=Emerging Markets;ERoW=Established Rest of World.OncologyAPPENDIX|Q1 2023 Product PerformanceQ1Q2Q
103、3Q4Q1Q2Q3Q4Q1202120222023EM306390315325406400406356444ERoW203234232245207231203206202Europe225244259258252256268245257US41543844148643951352153552102004006008001,0001,2001,4001,600Total Revenue($m)Q1Q2Q3Q4Q1Q2Q3Q4Q1202120222023EM587578655875906381ERoW971061011011011049997134Europe1091181201381251421
104、35142163US29230531933031537441345052201002003004005006007008009001,000Total Revenue($m)Lynparza14%decrease at CER to$651mLynparzaCollaboration Revenue:$3.8bn recorded cumulative,$3.9bn future potential36OncologyAPPENDIX|Q1 2023 Product PerformanceQ1Q2Q3Q4Q1Q2Q3Q4Q12021202120222023Sales Milestone-400
105、-Regulatory Milestone-175-75105-0200400600Collaboration Revenue($m)Q1Q2Q3Q4Q1Q2Q3Q4Q12021202120222023EM879996103121120117130137ERoW546767716672646668Europe149153155161160169164162178US2532692702942703123143312680100200300400500600700800Total Revenue($m)CER=constant exchange rates;EM=Emerging Markets
106、;ERoW=Established Rest of World.Collaboration partners:Merck&Co.,Inc.(Lynparza).Product SalesCalquence31%growth at CER to$532mEnhertu3x growth at CER to$257m37OncologyAPPENDIX|Q1 2023 Product PerformanceQ1Q2Q3Q4Q1Q2Q3Q4Q1202120222023EM255878121718ERoW33481318182022Europe922374355677986108US195250308
107、3363393964574653840100200300400500600700Total Revenue($m)Q1Q2Q3Q4Q1Q2Q3Q4Q1202120222023EM1345917252938ERoW-12233Europe469132026313355US354045495773124151161050100150200250300Total Revenue($m)CER=constant exchange rates;EM=Emerging Markets;ERoW=Established Rest of World.Collaboration partners:Daiichi
108、 Sankyo(Enhertu).38BioPharmaceuticals:Cardiovascular,Renal&MetabolismAPPENDIX|Q1 2023 Product PerformanceFarxiga39%growth at CER to$1,324mBrilinta5%growth at CER to$334mLokelma64%growth at CER to$98mQ1Q2Q3Q4Q1Q2Q3Q4Q1202120222023EM260297320318391423410441498ERoW6068637899988472138Europe1741982132253
109、18309329342393US13117120222819327527932329602004006008001,0001,2001,400Total Revenue($m)Q1Q2Q3Q4Q1Q2Q3Q4Q1202120222023EM1057476716978766482ERoW1517161614141086Europe889085837673656767US166194198178166185187206179050100150200250300350400Total Revenue($m)Q1Q2Q3Q4Q1Q2Q3Q4Q1202120222023EM111-0329611ERoW
110、61013151518171820Europe2335678911US242532343939454856020406080100120Total Revenue($m)CER=constant exchange rates;EM=Emerging Markets;ERoW=Established Rest of World.39BioPharmaceuticals:Respiratory&ImmunologyAPPENDIX|Q1 2023 Product PerformanceFasenra13%growth at CER to$338mBreztri73%growth at CER to
111、$144mTezspire32%sequential growth at CER to$54mQ1Q2Q3Q4Q1Q2Q3Q4Q1202120222023EM3575710121314ERoW384141433736353535Europe637375757578777688US156201199234189230229257201050100150200250300350400450Total Revenue($m)Q1Q2Q3Q4Q1Q2Q3Q4Q1202120222023EM91714152221282138ERoW57687109910Europe11235981115US123125
112、475353587581020406080100120140160Total Revenue($m)Q1Q2Q3Q4Q1Q2Q3Q4Q1202120222023EM-ERoW-24Europe-27US-3132637430102030405060Total Revenue($m)CER=constant exchange rates;EM=Emerging Markets;ERoW=Established Rest of World.Collaboration partners:Amgen(Tezspire).Symbicort7%growth at CER to$688m40BioPhar
113、maceuticals:Respiratory&ImmunologyAPPENDIX|Q1 2023 Product PerformancePulmicort9%growth at CER to$221mQ1Q2Q3Q4Q1Q2Q3Q4Q1202120222023EM165141151152167139169133229ERoW929996969198919579Europe168176155171157155133137147US2662642742622592222372552330100200300400500600700800Total Revenue($m)Q1Q2Q3Q4Q1Q2Q
114、3Q4Q1202120222023EM28611917319316472103123182ERoW11121213131212129Europe161815231817141920US171817192215161210050100150200250300350Total Revenue($m)CER=constant exchange rates;EM=Emerging Markets;ERoW=Established Rest of World.41Q3 2021 Total Revenue shows the numbers reported by AstraZeneca followi
115、ng the acquisition of Alexion,which completed on 21 July 2021.CER=constant exchange rates;EM=Emerging Markets;ERoW=Established Rest of World.Rare DiseaseAPPENDIX|Q1 2023 Product PerformanceSoliris13%decrease at CER to$834mUltomiris61%growth at CER to$651mStrensiq28%growth at CER to$262mQ1Q2Q3Q4Q1Q2Q
116、3Q4Q1202120222023EM-5311771638483115ERoW-861111071741049188Europe-199240221216190179183US-46060859157452349144802004006008001,0001,200Total Revenue($m)Q1Q2Q3Q4Q1Q2Q3Q4Q1202120222023EM-542464413ERoW-56737072779098Europe-69100105120122134159US-1672142202363153653810100200300400500600700Total Revenue($m)Q1Q2Q3Q4Q1Q2Q3Q4Q1202120222023EM-469981015ERoW-15201919191921Europe-16201921181921US-124173161193192224205050100150200250300Total Revenue($m)