Gsk Plc · LSE:GSK
Gsk — ViiV Healthcare — Investor Day (February 2017)
31 slides from Gsk's investor day presentation, Feb 15, 2017
Slide 1: ViiV Healthcare investor & analyst update
ViiV Healthcare investor & analyst update 15 February 2017 David Redfern, GSK Chief Strategy Officer and Chairman, ViiV Healthcare Dr. Dominique Limet, Chief Executive Officer, ViiV Healthcare Dr. John Pottage, Chief Scientific and Medical Officer, ViiV Healthcare 1
Slide 2: An ambitious vision
An ambitious vision Establish ViiV Healthcare as the leading company in the HIV market in innovation, sales and reputation 2
Slide 3: The HIV epidemic remains a substantial challenge of our time
The HIV epidemic remains a substantial challenge of our time 36.7 m people living with HIV worldwide1 2.1m infections and 1.1m ADULTS WOMEN CHILDREN (<15 years) AIDS-related deaths per year globally1 2.4m people living with HIV in Western and Central Europe and North America1 34.9 million1 17.8 mill
Slide 4: ViiV is the second largest HIV company globally, and the fastest-growing
ViiV is the second largest HIV company globally, and the fastest-growing £19.7 bn global HIV market Total HIV market performance by company Key Competitor 1 MAT sales 60% £10bn Market share 51% +18% MAT growth 50% MAT Value Share 40% ViiV Healthcare £4bn* 30% Competitor 2 20% £2.5bn +46%* 13% Compet
Slide 5: Guideline updates drive market evolution
Guideline updates drive market evolution Dolutegravir (DTG) now widely recognised as leading core agent 2013 2014 2015 2016 October 2013 November 2014 November 2015 July 2016 DHHS EACS added DTG WHO added DTG IAS recommends + Epzicom/Kivexa as alternative first recommends integrase or + Truvada for
Slide 6: Amongst integrase inhibitors, dolutegravir stands out
Amongst integrase inhibitors, dolutegravir stands out Unprecedented and unmatched Unique product characteristics clinical trial results in HIV Rapid and potent antiviral activity vs.efavirenz efavirenz vs. raltegravir raltegravir darunavirvs.atazanavir darunavir vs. efavirenz raltegravir atazanavi
Slide 7: DTG leads the market as the #1 core agent in the US
DTG leads the market as the #1 core agent in the US Weekly US TRx volume share (STR + core agent) – 30% since Tivicay launch 25% DTG total 23% 20% Competitor 20% Competitor 13% 15% Competitor 13% 10% Competitor 9% 5% 0% Source: IMS data to 27 January 2017. #1 meaning most prescribed 7
Slide 8: DTG leads the market as the #1 core agent in the top European markets and Japan
DTG leads the market as the #1 core agent in the top 5 European markets and Japan EU5 total volume (DoT) share Japan total volume (DoT) share (STR + core agent) – since Tivicay launch (STR + core agent) – since Tivicay launch 25% 40% DTG total 39% 35% 20% DTG total 18% 30% 15% Competitor 17% 25% Com
Slide 9: A growing body of evidence to support two drug regimens (2DR)
A growing body of evidence to support two drug regimens (2DR) DTG/CAB uniquely suited for 2DRs Scientifically viable Encouraging initial clinical data Long term treatments with improved adverse event profile Unmet medical need Ageing HIV patient population with co-morbidities Persistent interest in
Slide 10: Our belief in the market evolution
Our belief in the market evolution 2 NRTI backbone Core Agent Core Agent 3rd agent 2 NRTI backbone 1 partner agent PAST PRESENT FUTURE 10
Slide 11: Phase III SWORD 1 & 2: Switch to DTG + RPV maintains virologic suppression
Phase III SWORD 1 & 2: Switch to DTG + RPV Maintains virologic suppression through 48 weeks 11
Slide 12: Introduction
Introduction • The requirement for life-long antiretroviral therapy (ART) for HIV infection has highlighted a need to minimize cumulative drug exposure • The potency, safety, and resistance barrier of dolutegravir (DTG) make it an ideal core agent for two-drug regimen (2DR) • The safety, tolerabilit
Slide 13: SWORD-1 and SWORD-2 Phase III Study Design
SWORD-1 and SWORD-2 Phase III Study Design Identically designed, randomized, multicenter, open-label, parallel-group, non-inferiority studies Screening Early switch phase Late switch phase Continuation phase 1:1 VL <50 c/mL DTG + RPV (N=513) on INI, NNRTI, DTG + RPV DTG + RPV or PI + 2 NRTIs CAR (N=
Slide 14: Subject Disposition: Early Switch Phase (Through Wk 52)
Subject Disposition: Early Switch Phase (Through Wk 52) Screeneda N=1339 Randomized and treated Randomized and treated DTG + RPV CAR n=513 n=511 Contributed VL Contributed VL to Wk48 to Wk48 n=486 (95%) n=487 (95%) Completed Early Withdrawals through Wk52 Completed Early Withdrawals through Wk52 Swi
Slide 15: Demographics and Baseline Characteristics
Demographics and Baseline Characteristicsa DTG + RPV CAR (n=513) (n=511) n (%) n (%) Age, mean (SD) 43 (11.1) 43 (10.2) ≥50 years 147 (29) 142 (28) Female 120 (23) 108 (21) Race, non-white 92 (18) 111 (22) CD4+ cell count, cells/mm3 (median) 611 638 ≤500 165 (32) 149 (29) >500 348 (68) 362 (71) Base
Slide 16: Snapshot Outcomes at Week 48 (Pooled)
Snapshot Outcomes at Week 48 (Pooled) Virologic outcomes Adjusted treatment difference (95% CI)a 100 95 95 DTG + RPV (n=513) CAR DTG + RPV CAR (n=511) 80 HIV-1 RNA <50 c/mL, % 60 -0.2 -3.0 2.5 40 20 -8 -6 -4 -2 0 2 4 6 8 Percentage-point difference 5 4 <1 1 0 DTG + RPV is non-inferior to CAR with re
Slide 17: Snapshot Outcomes at Week 48 (SWORD-1&2)
Snapshot Outcomes at Week 48 (SWORD-1&2) Virologic outcomes Adjusted treatment differences (95% CI)a 100 95 96 94 94 DTG + RPV (n=252) CAR DTG + RPV SWORD-1 CAR (n=256) 80 DTG + RPV (n=261) HIV-1 RNA <50 c/mL, % SWORD-2 SWORD-1 -0.6 CAR (n=255) -4.3 3.0 60 SWORD-2 0.2 40 -3.9 4.2 20 -10 -8 -6 -4 -2
Slide 18: Snapshot Outcomes at Week 48
Snapshot Outcomes at Week 48 Early switch phasea DTG + RPV CAR n=513 n=511 n (%) n (%) Virologic success 486 (95) 485 (95) Virologic non-response 3 (<1) 6 (1) Data in window not <50 c/mL 0 2 (<1) Discontinued for lack of efficacy 2 (<1) 2 (<1) Discontinued while VL not <50 c/mL 1 (<1) 1 (<1) Change
Slide 19: Confirmed Virologic Withdrawals
Confirmed Virologic Withdrawals Early switch phasea DTG + RPV CAR n=513 n=511 n (%) n (%) Confirmed Virologic Withdrawal (CVW)b 2 (<1) 2 (<1) • One subject on DTG + RPV meeting virologic withdrawal criteria had identified an NNRTI resistance–associated mutation (K101K/E) • No INI resistance–associat
Slide 20: Adverse Events with Onset through Week 52
Adverse Events with Onset through Week 52 Early switch phasea DTG + RPV CAR (n=513) (n=511) n (%) n (%) Any AE 395 (77) 364 (71) AEs occurring in ≥5% of subjects in either group Nasopharyngitis 49 (10) 50 (10) Headache 41 (8) 23 (5) Upper respiratory tract infection 24 (5) 37 (7) Diarrhea 32 (6) 27
Slide 21: Adverse Events Leading to Withdrawal
Adverse Events Leading to Withdrawal DTG + RPVa,b (n=513) n (%) Subjects with AEs leading to withdrawal from the study 21 (4) Events Leading to Withdrawal (subject may report >1 AE) Anxiety 4 (<1) Depression 3 (<1) Abdominal distention 2 (<1) Dyspepsia 2 (<1) Insomnia 2 (<1) Depressed mood 1 (<1) Dr
Slide 22: Change in Serum Lipids at Week 48
Change in Serum Lipids at Week 48 Pooled Data Early Switch Phase DTG/RPV CAR Baseline Week 48 Baseline Week 48 200 5 185.9 186.0 187.6 188.1 4 150 Mean values, mg/dL 3.8 3.7 3.8 3.7 133.1 132.0 133.1 121.3 3 100 107.1 108.1 108.3 107.3 2 50 52.7 54.2 53.6 54.9 1 0 0 Total HDL LDL Triglycerides Total
Slide 23: Change in Bone Markers at Week 48
Change in Bone Markers at Week 48 Pooled Data Early Switch Phase DTG/RPV CAR Baseline Week 48 Baseline Week 48 60 55.3 54.7 50 53.0 Mean values, µg/L 45.6 40 30 20 23.8 24.0 23.1 19.0 15.9 16.2 17.1 10 12.9 0 Bone-specific Osteocalcin Procollagen 1 alkaline phosphatase N-terminal propeptide P<0.001*
Slide 24: Conclusions
Conclusions • A switch to a novel, once-daily 2DR of DTG + RPV demonstrated high efficacy and was non-inferior to the continuation of a 3- or 4DR in virologically suppressed HIV-1–infected adults • The safety profiles of both DTG and RPV were consistent with their respective labels • Switching to DT
Slide 25: Emerging clinical support on 2DR
Emerging clinical support on 2DR 2017 2018 INTERNAL STUDIES SWORD 1 & 2 (DTG+RPV switch) ▲ GEMINI 1 & 2 (DTG+3TC naïve) ▲ ATLAS & FLAIR (CAB+RPV naïve & switch) ▲ INVESTIGATOR INITIATED STUDIES* PADDLE 96 weeks (DTG+3TC naïve) ▲ ACTG 5353 (DTG+3TC naïve) ▲ ASPIRE (DTG+3TC switch) ▲ DUALIS (DTG+DRV/r
Slide 26: Innovative pipeline addressing unmet patient needs
Innovative pipeline addressing unmet patient needs Search for Prevention remission cabotegravir long-acting: PhIII underway and cure Long-acting treatment regimens cabotegravir + rilpivirine: PhIII underway New MOA Attachment inhibitor Dolutegravir-based regimens Maturation inhibitors Tivicay and Tr
Slide 27: Two Drug Regimen Phase III treatment study designs
Two Drug Regimen Phase III treatment study designs 27
Slide 28: DTG + RPV: SWORD 1 and 2
DTG + RPV Phase III started May 2015 SWORD 1 and 2 Population Maintenance therapy for adult patients with HIV-1 infection Number of patients 1,000 virologically suppressed patients Study design Phase III, randomised, open-label study to assess the safety and efficacy of switching to DTG + RPV versus
Slide 29: DTG + 3TC: GEMINI 1 and 2
DTG + 3TC Phase III started August 2016 GEMINI 1 and 2 Population Treatment for HIV-1 infection in adults who have not received prior antiretroviral therapy Number of patients 1,400 naive patients Study design Phase III, randomised, multicentre, non-inferiority studies to evaluate the efficacy, safe
Slide 30: CAB + RPV: FLAIR and ATLAS
CAB + RPV Phase III started November 2016 FLAIR and ATLAS Population Maintenance therapy for adult patients with HIV-1 infection Number of patients 1,200 virologically suppressed patients FLAIR study design Phase III, randomised, open-label, multicentre, parallel-group, non-inferiority study designe
Slide 31: Q&A
Q&A Healthcare