Gsk Plc · LSE:GSK
Gsk — ViiV Healthcare — Investor Day (December 2018)
46 slides from Gsk's investor day presentation, December 2018
Slide 1: ViiV Healthcare Meet the Management
ViiV Healthcare Meet the Management
Slide 2: ViiV Healthcare Meet the Management
ViiV Healthcare Meet the Management David Redfern Deborah Waterhouse John C. Pottage Jr MD, Chairman CEO Chief Scientific & Medical Officer Kimberly Smith MD, Eric Dube Global Research & Medical Head of North America Strategy CONFIDENTIAL Ideas are draft and subject to discussion with GAPPAC and leg
Slide 3: Cautionary statement regarding forward-looking statements
Cautionary statement regarding forward-looking statements This presentation may contain forward-looking statements. Forward-looking statements give the Group’s current expectations or forecasts of future events. An investor can identify these statements by the fact that they do not relate strictly t
Slide 4: 30 years and counting – our fight against HIV
30 years and counting – our fight against HIV Our scientists began work on Our portfolio now consists of developing treatments from A wealth of virology 13 antiretroviral medicines the beginning of the AIDS experience led to the offering a range of options for epidemic in the 1980s development peopl
Slide 5: Our unique model
Our unique model ViiV Healthcare shareholding* GSK (85%) 2009 and Pfizer (15%) create a joint venture dedicated to HIV treatments Shionogi (10%) Utilise GSK External support 2012 The Japanese company becomes new partner infrastructure from Pfizer and and shareholder* Strategy Shionogi Manufacturing
Slide 6: Deborah Waterhouse CEO
Deborah Waterhouse CEO CONFIDENTIAL Ideas are draft and subject to discussion with GAPPAC and legal 6
Slide 7: To leave no person living with HIV behind
To leave no person living with HIV behind 7
Slide 8: The shape of our business
The shape of our business SEPT YTD £360m North America £877m Europe International £2,203m 8
Slide 9: Our strategy: Innovation Performance Trust
Our strategy Innovation Performance Trust Dolutegravir (DTG) is the #1 #1 company in the Patient View Innovative pipeline for prevention, core agent globally, with 600k treatment, remission and cure ‘Corporate Reputation of Pharma’ PLHIV now taking a DTG-based for the fourth year running regimen Pos
Slide 10: Our performance
DTG the leading core agent More than 600,000 people worldwide and demonstrated DTG total share in the US taking DTG worldwide superiority in 5 studies vs holding firm competitors Our performance Juluca launched Projected to Positive Phase III studies for strongly – DTG/3TC FDC grow global sales, sha
Slide 11: Our innovative and competitive pipeline
Our innovative and competitive pipeline New treatment paradigm = 2DR Search for Remission Two-drug Regimens and Cure Juluca: dolutegravir/rilpivirine dolutegravir/lamivudine FDC* Current standard of care = HAART/legacy drugs Long-acting Treatment Regimens cabotegravir + rilpivirine* Dolutegravir-bas
Slide 12: Kimberly Smith MD, Global Research and Medical Strategy
Kimberly Smith MD, Global Research and Medical Strategy
Slide 13: From evolution to revolution: entering the 2DR era
From evolution to revolution: entering the 2DR era New treatment paradigm = 2DR Search for Remission Two-drug Regimens and Cure Juluca: dolutegravir/rilpivirine Current standard of dolutegravir/lamivudine FDC* care = HAART/legacy drugs Long-acting Treatment Regimens cabotegravir + rilpivirine* Dolut
Slide 14: The impact of a 2DR on a lifetime of HIV treatment
The impact of a 2DR on a lifetime of HIV treatment Unboosted Boosted triple-therapy triple-therapy regimen Unboosted 2DR (QD) regimen (QD) (QD) No. of drug doses/year 1,460 1,095 730 No. of drug doses per 57,086 42,815 28,543 39.1 years1 Notes: Drug dose refers to the aggregate number of doses of ea
Slide 15: Complexity of HIV treatment in an ageing HIV population
Complexity of HIV treatment in an ageing HIV population Expected patient exposure to ART now exceeds 40 years1 Common drug- Prevalence of non-HIV/AIDS defining drug interactions: chronic conditions have been shown Statins to increase with age2 Anti-fungals Oral contraceptives/hormone replacement Car
Slide 16: PLHIV have concerns about long-term effect of medicines
PLHIV have concerns about long-term effect of medicines 73% of participants sometimes worried about the long-term effects of their HIV medication 0 50 100 150 200 250 300 Weight, % Reduces long-term effects of HIV medicine on my body Most 25.0 Longer lasting so I can take treatment less often (e.g.
Slide 17: Why are we confident in 2DR? DTG most potent ARV to date
Why are we confident in 2DR? DTG most potent ARV to date Proof-of-concept ART monotherapy: maximum change in HIV RNA (log10) over 7–14 days 0.0 Maximum HIV RNA reduction (log10)¶ 300 mg BID 300 mg BID 300 mg QD 40 mg QD 10 mg single-dose 200 mg QD 600/100 mg BID 500 mg QD 50/100 mg QD 200/100 mg or
Slide 18: DTG-based 2DR inhibit viral life cycle at separate sites as 3DR does
DTG-based 2DR inhibit viral life cycle at 2 separate sites as 3DR does Lamivudine Adapted from Kasper DL, Hauser SL, Jameson JL, Fauci AS, Longo DL, Loscalzo, eds. Harrison’s Principles of Internal Medicine. 19th Ed. New York, NY: McGraw Hill; 2012. 1. JULUCA [package insert]. ViiV Healthcare: Resea
Slide 19: DTG-based 2DR demonstrates potency equal to 3DR
DTG-based 2DR demonstrates potency equal to 3DR in patients with high and low viral loads All participants Participants with baseline 0 HIV-1 RNA >100,000 c/mL Mean (95% CI) change from baseline in 0 DTG + 3TC DTG + 3TC plasma HIV-1 RNA, log10 c/mL -1 DTG + TDF/FTC DTG + TDF/FTC -1 -2 -2 -3 -3 -4 -4
Slide 20: ViiV Healthcare's 2DR portfolio
ViiV Healthcare’s 2DR portfolio Juluca DTG + CARLA* 3TC ViiV Healthcare’s first The next step in the 2DR The long-acting 2DR 2DR once-daily, journey, DTG + 3TC of CAB + RPV single pill for 2DR for treatment-naïve ATLAS maintenance of and switch patients suppression that FLAIR GEMINI 1 & 2 combines D
Slide 21: DTG + 3TC milestones
DTG + 3TC milestones Anticipated JULY 2018 FDC EU OCT 2018 Q2 2019 DTG/3TC regulatory EU Type II GEMINI 1 & 2 FDC EU submission variation 96 week data approval GEMINI 1 & 2 US Anticipated 48 week full regulatory US results SEPT 2018 submission NOV 2018 approval Q3 2019 presented at AIDS conference 2
Slide 22: What do HIV clinicians say about 2DR?
What do HIV clinicians say about 2DR? “These results are very encouraging, showing that a two-drug initial regimen of dolutegravir and lamivudine is plausible and very effective. It also has major advantages in terms of drug exposure.” Paul E. Sax, MD Clinical Director of the HIV Program and Divisio
Slide 23: DTG-based 2DR data has accelerated use of 2DR regimens
DTG-based 2DR data has accelerated use of 2DR regimens Patient Volumes in the US 22,000 Nearly 21,000 20,000 18,000 16,000 14,000 12,000 Source: IQVIA Custom Patient Data-Monthly Regimen, Jan 2016-Sep 2018 23
Slide 24: CARLA milestones
CARLA milestones US/EU H2 2019 Q3 2018 Q1 2019 Anticipated FLAIR meets regulatory primary EP submissions US approval ATLAS meets ATLAS & ATLAS 2M primary EP FLAIR read out Q4 2018 Q2-Q3 2019 Q1 2020 presentations 24
Slide 25: What do PLHIV say about long-acting injectables? (CARLA)
What do PLHIV say about long-acting injectables? (CARLA) “ It's less and less stigmatised with the injection, because I don't feel like I'm reminding myself of [HIV]…with the injection you go through days and weeks…two months not having to worry about that, so it's less stigmatised. ” “ In reality,
Slide 26: Continuing to disrupt and innovate
Continuing to disrupt and innovate JULY 2018 SEPT 2018 OCT 2018 Q1 2019 H2 2019 Q3 2019 Q1 2020 DTG/3TC CARLA US/EU DTG/3TC ATLAS meets FLAIR meets EU Type II Anticipated regulatory Anticipated primary EP primary EP variation US approval submissions EU approval GEMINI 1&2 DTG/3TC FDC DTG/3TC US ATLA
Slide 27: Eric Dube Head of North America
Eric Dube Head of North America CONFIDENTIAL Ideas are draft and subject to discussion with GAPPAC and legal 27
Slide 28: Significant opportunity for improved treatment and growth in US HIV market
Significant opportunity for improved treatment and growth in US HIV market 1,338 1,600 1,164 Estimated Patients in Thousands 1,400 819 1,200 Only ~50% of all PLHIV 1,000 672 are suppressed 800 ~87% ~70% ~82% 600 400 200 PLWHIV Diagnosed Total ART Suppressed ~50% Source: IQVIA LAAD, ViiV Internal Dat
Slide 29: US Payer Channel Distribution for HIV Market
US Payer Channel Distribution for HIV Market HIV Lives by Channel 45% 40% 39% 38% 35% 30% 25% 21% 20% 15% 10% 5% 0% Government Mandated Employer/Private Medicare Part D Rebate* HIV Lives % by Channel Note: 2% are uninsured Source: 2017 Projection of ViiV Patient Lives. Adapted from HIV Enrollment Mo
Slide 30: Strong data and commercial execution results in maintained DTG market share
Strong data and commercial execution results in maintained DTG market share R4WA TRx shares by product (STR+core agent)* 30% 27.4% 25% 20% TRx Share 15% 13.3% 12.9% 10% 9.9% 5% 1.2% 0% DTG Total Triumeq Tivicay Juluca Competitor CONFIDENTIAL Ideas are draft and subject to discussion with GAPPAC and
Slide 31: Customers continue strong support for DTG-based regimens
Customers continue strong support for DTG-based regimens New* Patient Volumes by Product Switch/Add Patient Volumes by Product (STR+Core agent) (STR+Core agent) 1,400 1,000 1,200 800 1,000 800 600 600 400 400 200 200 0 0 DTG Total Triumeq Tivicay Juluca DTG Total = Tivicay + Triumeq + Juluca New = F
Slide 32: On track with 3 pillars for driving oral 2DR paradigm shift
On track with 3 pillars for driving oral 2DR paradigm shift Establish strong, robust set of DTG-based 2DR clinical data Drive HCP confidence in the power of DTG- based 2DRs Ensure patient awareness of/demand for DTG-based 2DR CONFIDENTIAL Ideas are draft and subject to discussion with GAPPAC and leg
Slide 33: Juluca new patient volume and number of prescribers continues to grow
Juluca new patient volume and number of prescribers continues to grow nearly 1 year post-launch Juluca Breadth and NBRx 250 100 wk data presentation @ AIDS 2018 200 R4WA Volume 150 100 50 0 R4WA NBRx R4WA Breadth CONFIDENTIAL Ideas are draft and subject to discussion with GAPPAC and legal 33 *Source
Slide 34: Actively addressing trends influencing US marketplace
Actively addressing trends influencing US marketplace Payer reforms and increased competition Shifting HIV patient and HCP demographics Heightened Patient Engagement CONFIDENTIAL Ideas are draft and subject to discussion with GAPPAC and legal 34
Slide 35: John C. Pottage Jr MD Chief Scientific and Medical Officer
John C. Pottage Jr MD Chief Scientific and Medical Officer
Slide 36: HIV patient pool continues to increase
HIV patient pool continues to increase >37 million HIV+ globally, estimated 1.8 million new infections 9.4 million don’t know their status1 in 20171 21.7 million people living with HIV were accessing antiretroviral therapy in 20171 Over £22b ARV market size PLHIV will continue to need new treatments
Slide 37: Our innovative approach to discovery and development
Our innovative approach to discovery and development New treatment paradigm = 2DR Search for Remission Two-drug Regimens and Cure Juluca: dolutegravir/rilpivirine Current standard of dolutegravir/lamivudine FDC* care = HAART/legacy drugs Long-acting Treatment Regimens cabotegravir + rilpivirine* Dol
Slide 38: ViiV pipeline strategy
ViiV pipeline strategy Prevention New mechanisms Fixed-dose of action combinations Treatment Viral replication Injectables cycle Remission/Cure Immunologics Long-acting 38
Slide 39: Cabotegravir long-acting for prevention (PrEP)
Cabotegravir long-acting for prevention (PrEP) • Event driven • Event driven; powered for superiority • Primary data expected after 2020 • Primary data expected after 2020 • Sponsored by Division of AIDS, US National • Collaboration with NIH and Bill & Melinda Institute of Allergy and Infectious Dis
Slide 40: The next wave of opportunity in HIV
Exploring novel delivery technologies for cabotegravir The next wave of opportunity in HIV Long acting Ultra Long Long acting Clinic Administered Acting1 Self Administered 1 greater than or equal to three months 40
Slide 41: Fostemsavir: a life-saving investigational medicine
Fostemsavir: a life-saving investigational medicine for patients with few or no treatment options left FDA breakthrough First-in-class – unique No cross-resistance therapy designation2 mechanism that blocks initial to other antiretrovirals1,3 US regulatory filing planned CD4 binding1 for 2H2019 Demo
Slide 42: Maturation inhibitors
Maturation inhibitors Drugs that work in new ways Maturation inhibitors block could be particularly protein processing late in the beneficial for highly viral replication cycle treatment-experienced patients who have extensive drug resistance ViiV is progressing oral and Oral programme to include lo
Slide 43: Vision for Biologics
Vision for Biologics Combinectin bNAbs Provide broad-spectrum biologic agent Long acting1 capable of once-monthly, Naturally long half-life (2–3 weeks) self-administered, subcutaneous and modifiable dosing for use as an all-in-one regimen, Role in remission and cure2 or as a partner for CAB or Poten
Slide 44: UNC-CH HIV Cure Center and QURA: A unique model for high-risk research
UNC-CH HIV Cure Center and QURA: A unique model for high-risk research UNC and ViiV scientists integrated into a joint venture based at the Chapel Hill campus with a shared scientific strategy to find a cure for HIV Long-term focus with promise: reverse HIV latency with fewer unwanted side effects 4
Slide 45: To leave no person living with HIV behind
To leave no person living with HIV behind
Slide 46: Appendix one: references (slide 17)
Appendix one: references (slide 17) 1. Gruzdev et al. AIDS 2003;17:2487–94 12. Friedman et al. CROI 2016; Abstract 437LB 2. Goebel et al. AIDS 2006;20:1721–6 13. Rousseau et al. J Infect Dis 2003;188:1652–8 3. De Jong et al. J Infect Dis 1997;175:966–70 14. Markowitz et al. J Acquir Immune Defic Syn