HIV And ViiV Healthcare - Home GSK

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HIV and ViiV HealthcareDr Dominique Limet, Chief Executive Officer, ViiV HealthcareDr John Pottage, Chief Scientific and Medical Officer, ViiV Healthcare

Overview1. ViiV Healthcare vision2. ViiV Healthcare history and operating model3. HIV market4. Dolutegravir (DTG)5. R&D strategy6. Concluding remarks2

ViiV Healthcare vision

An ambitious visionEstablish ViiV Healthcare as the leading companyin the HIV market in innovation, sales and reputation4

ViiV Healthcare history and operatingmodel

A rich HIV history joined under a unique model2009201220132016ViiV Healthcare shareholdingGSK (85%)and Pfizer (15%)create a joint venturededicated to HIV treatmentsShionogi (10%)The Japanese companybecomes new partner andshareholder*Dolutegravir eraFirst dolutegravir (DTG)launch in the USViiV Healthcareacquires BMS’ HIVpipeline anddiscovery assetsHighly relianton ance markets)Administrative andfunctional (HR, IT,Legal, Finance)*Current shareholding of ViiV Healthcare: GSK 78.3%, Pfizer 11.7%, Shionogi 10%StrategyDrug discovery anddevelopmentMedical affairsMarketingSalesPublic affairsGlobal operationsResource managementPerformance managementExternal supportfrom Pfizer andShionogiR&D supportManufacturing6

End to end operation reliant on the scale andinfrastructure of large Pharma shareholders315900 150regions – North America,Europe and Internationalaffiliates and a presence inmore than 50 countriesthrough GSKemployeesworldwideemployees working inAlliance markets*244222450 employees working forGSK in R&D for ViiVHealthcareemployees working for ViiVHealthcare through sharedservice agreementsplanned, concluded and activeclinical trials since creation,including BMS acquisitions*Alliance markets: Agreement with GSK in markets were ViiV Healthcare is not a legal entity7

ViiV Healthcare success to date has evolved in twophases – First Phase: 2009 - 2013Re-energised commercial operation and R&D20091. Led the Epzicom/Kivexa turnaround30%25%20132. Created an unprecedented developmentprogramme to catapult DTG’s successGlobal Quarterly Growth20%15%10%5%0%-5%Source: GSK reported financial results8

ViiV Healthcare success to date has evolved in twophases – Second Phase: 2013 - TodayEmerging Leadership: market growth and innovation20131) DTG success fuelling ViiV Healthcare growthSplit of ViiV Healthcare sales since 2009Today2) Commitment to true innovation thatdelivers real patient benefit2,500Search forRemissionand CurePreventionSales in mcabotegravir long-acting*2,0001,500Long-acting Treatment Regimenscabotegravir rilpivirine*1,000500Tivicay and Triumeq02009 2010 2011 2012 2013 2014 2015Other productsproductsOtherEpzicom/Kivexa New productsNew productsEpzicomLegacy ARV Drug Portfolioabacavir/lamivudine,maraviroc & othersSource: Reported Financial Results* Note, therapies denoted with an (*) are investigational; safety and efficacy in treating/preventing HIV has not been establishedNew MOAGSK3684934* previously BMS663068; attachment inhibitorMaturation Inhibitors*Allosteric Integrase Inhibitors*Combinectin*Dolutegravir-based RegimensDTG 2-Drug vudine*9

The HIV market

The HIV epidemic remains a substantial challengeof our time36.7mpeople living withHIV worldwide12.1m infections and 1.1mAIDS-related deaths per year globally12.4m people living with HIV in Westernand Central Europe and NorthAmerica1ADULTSWOMENCHILDREN ( 15 years)34.917.81.8million1million1million1Patients are living longer and infection rates have begun to rise againTreatment rate in developed markets is only 50-70%2,3IAS July 2016 recommends that all people living with HIV should receive treatmentSource: 1. UNAIDS. Core epidemiology slides. June 2016; 2. IMS World Model Dec'15; 3. IMS local monthly model (Mar'16)11

A highly dynamic marketHIV market valued at 16 billion in 2015Dynamic SegmentReported reason for patients switching to a new therapy asreported by physicians (N 246)1% 15-35% of the market per year2%3%SimplificationToxicity8%4%Clinical trial inclusion32%Initiation (naive) 5-10%6%Virological failureDrug-drug interactionPatient decision13%Lack of adherenceSwitch 10-25%Pregnancy31%OtherStable segment 65-85%Source: IMS MIDAS Database, Ipsos and IMS NBRx, and GSK internal analysis. Carrero-Gras A, et al. J Int AIDS Soc 2014;17(Suppl 3):1981912

The market has been receptive to innovationand remains a strong opportunity for growth 16B 12.7B3rd agents 5.0BSTRs 3.5BNRTI backbone 4.1BGenerics2013Source: IMS MIDAS pleraEpzicom/KivexaTruvada3rd agents 5.4BSTRs 5.9BNRTI backbone defseyEpzicom/KivexaDescovyTruvadaGenerics201513

Guideline updates drive market evolution2013October 2013DHHSrecommendsintegrase inhibitorbased regimensincluding DTG Epzicom or Truvada aspreferred for ARTnaive patients201420152016DHHSOctoberintegrase July 2016November20142013 recommendsNovember 2015inhibitor-basedincludingEACSadded DTG regimensWHO addedDTGDTG IAS Epzicom/Kivexaas alternativefirst for ARTrecommends Epzicom or Truvadaas preferredor Truvadaforline treatmentinitial regimensnaive patientsART naive patientsconsisting of anintegraseinhibitor plus twoNRTIs14

We have now entered the integrase inhibitor eraINIs represent 46% of the TRx market, a figure that will continue to growCore Agent share of US TRxs(Core Agents only, STRs allocated to Core Agent yaLaunchINI dynamicshare 70%in the US rotease inhibitorsSource: IMS NPA Monthly Jul 2016Non-nucleoside inhibitorsEntry inhibitorsIntegrase inhibitors15

Dolutegravir

Amongst integrase inhibitors, DTG stands outUnprecedented and unmatched clinicaltrial (naive)(women / naive)Unique product characteristicsRapid and potent antiviral activityatazanavirDrug-Drug interactions (DDIs)Few clinically significant DDIs,Unboosted High barrier to resistance DOLUTEGRAVIRNON INFERIORIn vitro findings supported by Phase IIIdataLong binding towild type integraseDissociation from mutant INDNA complexes slower vs RALor EVG(naive)Well toleratedelvitegravir /cobicistatNON INFERIORSUPERIOR(naive)(women / naive)raltegravirNON INFERIORNON INFERIOR(naive)(naive)SINGLE, FLAMINGO, SPRING 2, SAILING and ARIA were non-inferiority studies with apre-specified analysis for superiorityChart shows primary endpoint outcomesFew discontinuationsdue to AEs in INI-naïveclinical trials Breadth and depthof clinical trial dataDTG superior vs EFV and DRV/r intreatment-naïve subjects and RAL intreatment-experienced subjectsLong half-life;low variability in exposureDTG (50 mg QD) exposures19-fold above IC90Long ‘tail’ - drug plasma concentrationsup to 216h post doseReferences: 1. Min S, et al. AIDS 2011;25:1737–45, 2. Walmsley S, et al. N Engl J Med 2013;369:1807–18, 3. Clotet B, et al. Lancet 2014;383:2222–31, 4. Cahn P, et al. Lancet 2013;382:700–8, 5. Raffi F, etal. Lancet,013;381:735–43, 6. Kobayashi M, et al. Antiviral Research 2008;80;213–22, 7. Kobayashi M, et al. Antimicrob Agents Chem 2011;55(20):813-821, 8. Hightower KE, et al. Antimicrob AgentsChemother 2011;5:4552–9, 9. van Lunzen J, et al. IAS 2011. Abstract TUAB0102, 10. van Lunzen J, et al. Lancet Infect Dis 2012;12:111–8, 11. Elliot E, et al. IWCPHIV 2015. Abstract 1317

Dolutegravir leads the market as the #1 core agentWeekly US TRx market share (STR core agent) – since Tivicay launch30%25%DTG total 19.7%20%Competitorfranchise 17.7%15%Competitorfranchise 15.6%10%CompetitorFranchise 9.1%5%0%Source: IMS data to 2 September 2016#1 meaning most prescribed18

And the #1 agent in dynamic share in the US30%25%20%15%10%New* Patient Shares by Product(STR Core agent)60%DTG cay13%Switch/Add Patient Shares by Product(STR Core agent)EXCLUDING conversions130%DTG total 38%Competitorfranchise34%Triumeq 21%20%Tivicay 18%5%10%0%0%1 Conversions switches from Truvada Sustiva to Atripla, Truvada Edurant to Complera, Tivicay Epzicom to Triumeq, Prezista to Prezcobix, Reyataz to Evotaz, Stribildto Genvoya, Complera to Odefsey. ** IMS “New” metric is a proxy for naïve patients. It represents a longitudinal IMS panel of patients with no prior HIV therapy RX in thelast 12 months, and overstates true naïve volume slightly.Source: IMS NBRX Custom HIV Report 26 August 2016. #1 meaning most prescribed.19

Already #1 agent in dynamic share in many otherkey markets# 1 in Naïve# 1 in SwitchFranceGermanyItalySpainUKCanadaJapanSources: IMS NBRX Custom HIV Report 08/19/2016 (US), Ipsos Scope Aug 2016 (FR, IT, SP, UK, JP), Lemon Wave 4 - June-July 2016 (GER), IMS Rx Dynamics (CA)#1 meaning most prescribed20

ViiV Healthcare is the only company with increasing growthin HIV over the past 12 months (from 34% to 53%)HIV Market Growth 12%MAT Market Share70%60%Global HIV market by valueCompetitor 1Key 9.1bn54% 14%50%MAT salesMarket shareMAT growth40%ViiV Healthcare30% 3.1bn18% 53%20%10%Competitor 2 1.7bnCompetitor 3Competitor 4 1.1bn10% 5%6%Competitor 5 0.9bn 0.5bn3%-22%0%-40%5%-16%-20%-7%0%20%MAT Sales GrowthSource: IMS Health MAT June 201640%60%80%

R&D strategy

Committed to innovation and leadership in HIVSearch forRemissionand CurePreventioncabotegravir long-acting*Long-acting Treatment Regimenscabotegravir rilpivirine*GSK3684934* previouslyBMS-663068; attachment inhibitorMaturation Inhibitors*Allosteric Integrase Inhibitors*Combinectin*Dolutegravir-based RegimensTivicay and TriumeqLegacy ARV Drug Portfolioabacavir/lamivudine,maraviroc & othersNew MOADTG 2-Drug vudine**Note, therapies denoted with an (*) are investigational; safety and efficacy in treating/preventing HIV has not been established23

Our belief in the market evolution2 NRTI backboneCore AgentCore Agent3rd agent2 NRTI backbone1 partner agentPASTPRESENTFUTURE24

Why can 2-drug regimens (2DR) succeed?Scientifically viableDTG/CAB uniquely positioned for 2DRsEncouraging clinical dataLong term treatments with improved adverse event profileUnmet medical needAgeing HIV patient population with co-morbiditiesPersistent interest in 2DR researchMarket demandMarket receptive to new treatment advances2DRs have the potential to challenge therapy standard25

ViiV Healthcare integrase inhibitors at the forefrontof the 2DR paradigm shiftEstablish DTG as theleading core agentin the market Challenge the threedrug paradigmDTG 3TCDTG RPVCAB RPV LA26

Cabotegravir LATTE and LATTE-2 StudiesDurable virologic suppression with oral and long-acting (LA) 2DRLATTE (oral CAB RPV)Week 96 Virologic OutcomesLATTE-2 (LA inj. CAB RPV)Week 48 Virologic Outcomes*Reference: Margolis et al, Lancet Inf Dis 2015;15(10):1145-1155 Margolis D et al., 21st IAC, abstract THAB0206LB, 2016*Cabotegravir abacavir lamivudine oral27

Investigator initiated 2DR studiesGARDELSALTLPV/r 3TCATV/r 3TCPADDLEASPIRELAMIDOLACTG 5353DUALISDTG DRV/rDOLATAVDTG ATV/rDTG 3TCLPV/r lopinavir boosted with ritonavir ; DRV/r darunavir boosted with ritonavir ; ATV/r atazanavir boosted with ritonavir28

DTG RPVPhase III started May 2015SWORD 1 and 2IndicationMaintenance therapy for adult patients with HIV-1 infectionNumber of patients1,000 virologically suppressed patientsStudy designPhase III, randomised, open-label study to assess the safety and efficacy ofswitching to DTG RPV versus continuing current antiretroviral regimenPrimary endpointThe primary endpoint is proportion of patients with plasma HIV-1 RNA 50 copiesper milliliter (c/mL) at week 48. Key secondary endpoints include evaluation ofthe development of viral resistance, measurements of safety and tolerability, andchanges in renal, bone and cardiovascular biomarkersExpected readout dateEnd of 2016Expected launch dateH1 201829

DTG 3TCPhase III started August 2016GEMINI 1 and 2IndicationTreatment for HIV-1 infection in adults who have not received prior antiretroviraltherapyNumber of patients1,400 naive patientsStudy designPhase III, randomised, multicentre, non-inferiority studies to evaluate theefficacy, safety, and tolerability of DTG 3TC QD versus DTG TDF/FTC FDCover 148 weeksPrimary endpointThe primary endpoint for these studies is non-inferior antiviral activity measuredby the proportion of participants with plasma HIV-1 RNA 50 copies/mL (c/ML) atweek 48Expected readout date2018Expected launch dateH1 201930

A growing body of evidence to support 2DR2016INTERNAL STUDIESSWORD 1 & 2GEMINI 1 & 22017 2018 ISS STUDIES*PADDLE 96 weeksACTG 5353ASPIREDUALISLAMIDOLDOLATAVForward-looking, dependant on data availability*ISS abstract are best estimates only and subject to change based on investigator decision Next available congress presentation 31

Why innovation should remain a priority in itorCCR5antagonistProtease inhibitorAttachmentinhibitorRT inhibitorIntegraseinhibitorReference: Lataillade et al. CROI 2015, Abstract 114LBProteaseinhibitor32

Concluding remarks

Our strategic priorities to ensure near and long termsuccessContinue to drive share in traditional 3 drug regimens through strength of DTGCreate a new paradigm in oral treatment through 2DRCreate a new paradigm in treatment through long-acting therapyContinue to lead HIV innovation with research that delivers new mechanismsoffering new options for patients most in need34

Q&A

Source: IMS MIDAS Database, Ipsos and IMS NBRx, and GSK internal analysis. Carrero-Gras A, et al. J Int AIDS Soc 2014;17(Suppl 3):19819 12 Initiation (naive) 5-10% Switch 10-25% Stable segment 65-85% Dynamic Segment 15-35% of the market per year 32% 31% 13% 6% 4% 3% 2% 1% 8% reported by physicians (N 246) Simplification Toxicity