20230109-cnfr-jpmorgan-prsn-all-sent GSK.pdf

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1、9 January 2023Delivering growth for the decade and beyondEmma Walmsley,Chief Executive OfficerJ.P.Morgan Healthcare Conference,San Francisco2This presentation may contain forward-looking statements.Forward-looking statements give the Groups current expectations or forecasts of future events.An inves

2、tor can identifythese statements by the fact that they do not relate strictly to historical or current facts.They use words such as anticipate,estimate,expect,intend,will,project,plan,believe,target and other words and terms of similar meaning in connection with any discussion of future operating or

3、 financial performance.In particular,these include statements relating tofuture actions,prospective products or product approvals,future performance or results of current and anticipated products,sales efforts,expenses,the outcome of contingencies suchas legal proceedings,dividend payments and finan

4、cial results.Other than in accordance with its legal or regulatory obligations(including under the Market Abuse Regulations,UK Listing Rules and the Disclosure Guidance and Transparency Rulesof the Financial Conduct Authority),the Group undertakes no obligation to update any forward-looking statemen

5、ts,whether as a result of new information,future events or otherwise.Investors should,however,consult any additional disclosures that the Group may make in any documents which it publishes and/or files with the US Securities and ExchangeCommission(SEC).All investors,wherever located,should take note

6、 of these disclosures.Accordingly,no assurance can be given that any particular expectation will be met andinvestors are cautioned not to place undue reliance on the forward-looking statements.Forward-looking statements are subject to assumptions,inherent risks and uncertainties,many of which relate

7、 to factors that are beyond the Groups control or precise estimate.TheGroup cautions investors that a number of important factors,including those in this presentation,could cause actual results to differ materially from those expressed or implied in anyforward-looking statement.Such factors include,

8、but are not limited to,those discussed under Item 3.D Risk factors in the Groups Annual Report on Form 20-F for the full year(FY)2021 and any impacts of the COVID-19 pandemic.Any forward-looking statements made by or on behalf of the Group speak only as of the date they are made and are based upon t

9、heknowledge and information available to the Directors on the date of this presentation.A number of adjusted measures are used to report the performance of our business,which are non-IFRS measures.These measures are defined and reconciliations to the nearest IFRSmeasure are available in our third qu

10、arter 2022 earnings release and Annual Report on Form 20-F for FY 2021.All outlooks,ambitions,and considerations should be read together with pages 5-7 of the stock-exchange announcement relating to an update to investors dated 23 June 2021,paragraph 19 of Part 7 of the Circular to shareholders rela

11、ting to the demerger of Haleon plc dated 1 June 2022 and the Guidance,assumptions and cautionary statements in the Q32022 earnings release.Basis of preparation:GSK satisfied the formal criteria according to IFRS 5 for treating Consumer Healthcare as a Discontinued operation effective from 30 June 20

12、22.On 18 July 2022,GSK plc separated its Consumer Healthcare business from the GSK Group to form Haleon,an independent listed company.The amounts presented in this presentation for continuingoperations and Adjusted results excludes the Consumer Healthcare business discontinued operation.Comparative

13、figures have been restated on a consistent basis.Earnings per share,Adjusted earnings per share and Dividends per share have been adjusted to reflect the GSK Share Consolidation on 18 July 2022.Cautionary statement regarding forward-looking statements3AgendaA focused global biopharma companyWorld le

14、ader in infectious diseases with an attractive pipeline based on the science of the immune systemCompetitive performance and outlookDelivering scale health impact sustainably41.Medium term is 2021-2026,2.At constant exchange rates(CER).A focused global biopharma companyAmbition and PurposeTo unite s

15、cience,technology,and talent to get ahead of disease togetherGrowthHighly attractive medium-term1target for sales and adjusted operating profit growth of 5%and 10%CAGR2FlexibilityStrengthened balance sheet,creating new flexibility to invest in growth and innovation51.Respiratory syncytial virus in o

16、lder adults,2.Excluding pandemic sales versus 66%including pandemic sales.Delivering transformation and performanceInnovationStrong pipeline of 23 vaccines and 42 medicinesCompetitive performance in new drug approvals:20 since 2018Achieved first approvals of long-acting HIV medicinesFirst US FDA reg

17、ulatory acceptance of RSV OA1candidate vaccineSmart business development Sierra Oncology,Affinivax,SperoPerformanceSuccessful demerger of Haleonto unlock shareholder valueDouble-digit sales and adjusted op.profit growth YTD 2022FY 2022 guidance raised twiceVaccines and Specialty Medicines 62%2YTD sa

18、les(vs 44%in 2017)Shingrix set for record salesOn track to deliver medium-term growth commitments Trust#1 position in the Access to Medicines Index for the 8th consecutive yearLeading position in Diversity,Equity and InclusionLeadership in S&P Corporate Sustainability AssessmentContinued progress of

19、 our net zero climate and net positive nature goals,including the launch of our Sustainability Procurement Programme6Vaccines and Specialty MedicinesMaximising opportunities in treatment and preventionIncreasing synergies across prevention and treatmentImmune dysfunction contributesto pathophysiolog

20、y of many diseases with scientific understanding rapidly evolvingConvergence of modalitiesto prevent and treat disease,e.g.,targeted immunotherapeutic vaccinesSignificant opportunity and advantageR&D focus on science of immune system,human genetics and advanced technologiesWorld leader in infectious

21、 diseasesOne capital allocation processIntegrated One Development organisationUnrivalled suite of Vaccine platform technologiesAttractive portfolio offering to payors7Note:select pipeline programmes shown.1.Respiratory syncytial virus in older adults,2.Broadly neutralising antibody,3.Integrase stran

22、d transfer inhibitor,4.Chronic obstructive pulmonary disease,5.Non-alcoholic steatohepatitis.Four focused therapeutic areasTwo thirds of our development portfolio comes from infectious disease and HIV Smart business developmentInfectiousDiseasesHIVImmunology/RespiratoryOncologyRSV OA1MenABCWYbepirov

23、irsengepotidacintebipenemPneumococcal 24-valentmRNA influenzaApretudeN6LS(bNAb)23rdgeneration INSTI3Capsid inhibitordepemokimabNucala(COPD)4GSK4532990(NASH)5momelotinibJemperlicobolimabCD226 axis8World leader in infectious diseasesCombined sales 13bn in last 12 months1Attractive,growing market worth

24、 100bn paGSK has leading market positions in Vaccines,HIV and important legacy role in antivirals and antibiotics Portfolio delivering strong growth2-Vaccines+20%(ex-pandemic)-HIV+9%Exciting pipeline of innovative clinical-stage assets across Vaccines,HIV and anti-infectivesInfectious diseases and H

25、IV together account for 50%of salesVaccines,30%HIV,20%Other ID(Augmentin),2%Other Specialty,12%General Medicines*,36%Nine months 2022 sales(million)331.Trailing 12 months to 30 September 2022 and excluding COVID-19 solutions,2.In nine months to 30 September 2022 and at Constant Exchange Rates(CER),3

26、.Infectious Diseases;*excluding Augmentin,3.Excluding pandemic sales.91.Excluding pandemic solutions(flu and COVID-19)and at CER.Please also refer to page 2 of the second quarter 2022 results announcement.All outlooks,targets,ambitions and expectations regarding future performance and the dividend s

27、hould be read together with the“Guidance,assumptions and cautionary statements”on page 69 of our second quarter 2022 earnings release.2021-26 CAGR is for the 5 years to 2026,using 2021 as the base year.A long history of innovation leadershipc.70-year history of vaccine development(introduced polio v

28、accines in 1950s)Broadest portfolio in the industry with 25 vaccines supplied across 160 countries15 new product launches since 2000Market leading in multiple categories,e.g.,shingles,meningitis,and paediatricsWorld class manufacturing,regulatory and technical expertise(high barriers to entry)Vaccin

29、e leadership0.86.3200020212026+10%CAGR1High single-digit%CAGRDriving innovative vaccines sales m1Focus on the right approach to develop the best vaccine for each pathogen10Unrivalled suite of vaccine technology platformsTechnology enables development of new vaccines not previously thought possiblePl

30、atform technologiesAdjuvants,bioconjugationGeneralised modules for membrane antigen(GMMA)Adenovirus vectorsmRNAMultiple Antigen Presentation System/bacterial technology11Note:pipeline as disclosed at Q3 2022 results,2 November 2022;after this date,Rotarix liquid and the COVID-19 vaccine 453001 have

31、received regulatory approval.Additionally,4348413A started phase I/II for prevention of gonorrhoea*In-license or other alliance relationship with third party;*Additional indications or candidates also under investigation;recomb.,recombinant;adjuvanted;GSK contributing pandemic adjuvant GSK has exclu

32、sive option to co-develop post phase II.1.In phase I/II trial;CMV:Cytomegalovirus;TCV:Thyphoid conjugate vaccine;iNTS:invasive non-typhoidal salmonella;TI,targeted immunotherapy;HSV,herpes simplex virus;GMMA,generalised modules for membrane antigens;HPV:Human papillomavirus;uUTI:uncomplicated urinar

33、y tract infection;MAPS:Multiple Antigen Presenting System;MenB:Meningitis B;PCV:Porcine circovirus;RSV:Respiratory syncytial virus.Industry-leading vaccines pipelinePotential first-in-class or best-in-class23 projects,including multiple potential first-or best-in-class opportunities2904545*(recomb p

34、rotein)C.difficile3437949*(recomb protein)Malaria fractional dose4429016*(bioconjugated,recomb protein)K.pneumoniae3878858*(bioconjugated,recomb protein)S.aureus1Bexsero paediatric/adolescent US(recomb protein)MenB3993129(recomb subunit)CMV4069327*(bioconjugated,tetravalent)Shigella*3536819(conjugat

35、ed,recomb protein)MenABCWY 1stgen4382276*(mRNA)flu3528869*(viral vector with recomb protein)TI HBV13844766*(recomb protein)RSV older adults3943104*(recomb protein)TI HSV4023393(conjugated,recomb protein)MenABCWY 2ndgen1Rotarix liquid US(live attenuated,PCV free)rotavirus4396687*(mRNA)COVID-195101955

36、*(MAPS)Pneumococcal 24-Valent-PaediatricCovifenz(Medicago)*COVID-19 4077164*(bivalent GMMA)iNTS(Typhimurium+Enteritidis)*5101956*(MAPS)Pneumococcal 24-Valent-Adults4353001(Sanofi)*COVID-19 4106647*(protein-adjuvant)HPV14178116(live,attenuated)Varicella new strainSKYCovione(SK Bioscience)*COVID-19 Ph

37、ase IPhase IIPhase III/Registration12Source;Ison,IDWeek 2022.1.Severe confirmed RSV-Lower Respiratory Tract Disease(LRTD)VE 94.1%(95%CI 62.4-99.9),2.LRTD in subjects with=1 comorbidity of interest VE=94.6%CI 65.9-99.9),3.RSV LRTD VE 93.8%(CI 60.2-99.9),4.Introduction to ACIPs Adult Respiratory Syncy

38、tial Virus Work Group:https:/www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-06-22-23/01-RSV-Kotton-508.pdf,5.Herring,W.et al.(2021),Carrico,J et al(2022);6.Additional impact from lost productivity,long-term health consequences and care costs.Note:Comorbidities included in 006 study include

39、d those with pre-existing chronic conditions such as chronic obstructive pulmonary disease,asthma,any chronic respiratory/pulmonary disease,chronic heart failure,diabetes mellitus type-1 or type-2 and advanced liver or renal disease.Around 39%of participants in both the placebo and the vaccine group

40、s had these pre-existing comorbidities.Innovation:potential best-in-class RSV vaccine in the most vulnerable adultsDemonstrated consistent and sustained high efficacy Efficacy in those with comorbidities294.6%Efficacy in those aged 70-79 years393.8%Reduction in severe disease194.1%Key risk factors a

41、re age and comorbidities Older adults at increased risk from RSV disease due to reduced immune function CDC:90%of hospitalised adults have underlying medical conditions(c.50%:3+)4 Those with comorbidities,e.g.,cardiovascular,respiratory,and diabetes,are at even higher risk of severe outcomes1 RSV ha

42、s substantial economic burden with direct medical costs c.$3bn5in US alone6131.Hepatitis B surface antigen,2.Nucleoside/nucleotide analogues,3.Uncomplicated urinary tract infections,4.Antimicrobial resistance.Addressing major anti-infective challengesChronic Hepatitis B(HBV)300 million living with H

43、BV infection900,000 HBV-related deaths per yearBepirovirsen has potential to be first-in-class functional cure for chronic HBVB-CLEAR end of phase IIb treatment data presented at AASLD 2022Demonstrated sustained clearance of HBsAg1and HBV DNA in patients with/without concurrent NA2therapyPhase III m

44、onotherapy study start in H1 2023,plus sequential therapy studiesResistant bacterial infections15 million uUTIs3per year in US38%resistant to one or more antibioticsGepotidacin could be first new novel oral antibiotic for uUTIs in 20 yearsGSKs most advanced clinical compound in its commitment to add

45、ressing AMR4Pivotal phase III EAGLE-2 and EAGLE-3 trials stopped early for efficacy in November 2022US NDA planned for H1 2023141.Integrase strand transfer inhibitor,2.People living with HIV,3.Long acting,4.Pre-exposure prophylaxis.Innovation pioneers in HIV treatment and prevention#1First 2nd gener

46、ation INSTI1First approved two-drug regimenFirst attachment inhibitor for highly treatment experienced PLHIV2First approved LA3injectable regimen for HIV treatmentFirst LA injectable for PrEP4First head-to-head trial of PrEP agents;showed superiority of LA injectable over daily oral pillExpected por

47、tfolio mix 202615Note:All outlook and ambition statements are given on a constant currency basis and use 2021 forecast exchange rates as a base,assuming a continuation of Q1 2021 closing rates.CAGR is for the 5 years to 2026,using 2021 as the base year.Pipeline sales are risk-adjusted and include an

48、ticipated sales of new products and Life Cycle Innovation(LCI)launched from 2021 onwards.All outlooks,targets,ambitions and expectations regarding future performance should be read together with the section“Basis of preparation,assumptions and cautionary statement on pages 5-7 of our stock exchange

49、announcement relating to an update to investors dated 23 June 2021 and with the section“Outlook,assumptions and cautionary statements”on pages 67 and 68 of our third quarter 2022 earnings release.Transforming our HIV portfolio in the next decadePortfolio transition through decade with LA regimens c.

50、2bn in sales by 2026Oral two drug regimensOther oral portfolioLA portfolio launched by 2022Post-2026 long-acting pipeline growth driversSelf-admin for treatmentUltra long-acting for treatmentUltra long-acting for PreP2021-2026 growth driversDovatoCabenuvaApretudeMid-single digit%sales CAGR 2021-26 w

51、ithpipeline optionality beyondGuidanceSales:8-10%growth Adj.operating profit:15-17%growthOutlookVaccines:mid to high teens%Specialty Medicines:low double-digit%General Medicines:broadly flatYear-to-date 2022 performance1Adj.Operating Margin:+50bp(to 29.9%2)Cash generated from Ops:5.8bn16Delivering o

52、ur commitments for attractive medium-term growthSales:5%CAGR Adj.operating profit:10%CAGRVaccines:high-single digit%CAGRSpecialty Medicines:double-digit%CAGRGeneral Medicines:broadly stableAdjusted Operating Margin:30%by 2026Cash generated from Ops:10bn by 2026 2021-2026 outlookFull year 2022 All ou

53、tlooks,targets,ambitions and expectations regarding future performance and the dividend should be read together with the section“Basis of preparation,assumptions and cautionary statements”on pages 5-7 of our stock exchange announcement relating to an update to investors dated 23 June 2021 and the“Ou

54、tlook,assumptions and cautionary statements”on pages 60 and 62 of our third quarter 2021 earnings release.All outlook and ambition statements are given on a constant currency basis and use 2021 forecast exchange rates as a base,assuming a continuation of Q1 2021 closing rates.CAGR is for the 5 years

55、 to 2026,using 2021 as the base year.Pipeline sales are risk-adjusted and include anticipated sales of new products and Life Cycle Innovation(LCI)launched from 2021 onwards.Note:COVID therapeutic and vaccine solutions are excluded from the above.1.Year-to-date and nine months 2022,2.Excluding COVID-

56、19 solutions.17Ambition to achieve growth through the decade and beyondHighly attractive medium-term growth from Vaccines and Specialty MedicinesGrowing contributions from first-or best-in-class pipeline opportunities,e.g.,RSV OA,bepirovirsen,depemokimab,gepotidacin,momelotinibManageable loss of exc

57、lusivity exposure through HIV portfolio transition to long acting Early pipeline and business development to supplement sales ambitionConfident in ability to deliver long-term sales ambition and growth through the decadeDriven by pipeline productivity andcommercial excellence18Delivering performance

58、 and health impact sustainablyAmbition to positively impact the health of 2.5 billion people over the next 10 yearsEnvironmentPricing and accessGlobal health and health securityDiversity,equity and inclusionProduct governanceOperating standards19A focused global biopharma company with high ambitions

59、Unique strategy focused on prevention and treatment of diseaseWorld leader in infectious diseases with an attractive pipeline based on the science of the immune systemCompetitive medium-term sales and profit outlook supported by landmark 2022Confident in ability to sustain growth through decade and beyond to deliver human health impact at scaleQ&A