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Gsk — ViiV Healthcare — Goldman Sachs seminar on HIV and ViiV Healthcare (September 2016)
35 slides from Gsk's conference presentation, September 2016
Slide 1: HIV and ViiV Healthcare
HIV and ViiV Healthcare Dr Dominique Limet, Chief Executive Officer, ViiV Healthcare Dr John Pottage, Chief Scientific and Medical Officer, ViiV Healthcare
Slide 2: Overview
Overview 1. ViiV Healthcare vision 2. ViiV Healthcare history and operating model 3. HIV market 4. Dolutegravir (DTG) 5. R&D strategy 6. Concluding remarks 2
Slide 3: ViiV Healthcare vision
ViiV Healthcare vision
Slide 4: An ambitious vision
An ambitious vision Establish ViiV Healthcare as the leading company in the HIV market in innovation, sales and reputation 4
Slide 5: ViiV Healthcare history and operating model
ViiV Healthcare history and operating model
Slide 6: A rich HIV history joined under a unique model
A rich HIV history joined under a unique model GSK (85%) ViiV Healthcare shareholding 2009 and Pfizer (15%) create a joint venture dedicated to HIV treatments Shionogi (10%) 2012 The Japanese company becomes new partner and shareholder* Highly reliant External support on GSK from Pfizer and Dolutegr
Slide 7: End to end operation reliant on scale and infrastructure of large Pharma shareholders
End to end operation reliant on the scale and infrastructure of large Pharma shareholders 3 15 900+ 150 regions – North America, affiliates and a presence in employees employees working in Europe and International more than 50 countries worldwide Alliance markets* through GSK 244 222 450+ employees
Slide 8: ViiV Healthcare success to date: First Phase 2009-2013
ViiV Healthcare success to date has evolved in two phases – First Phase: 2009 - 2013 2009 Re-energised commercial operation and R&D 2013 1. Led the Epzicom/Kivexa turnaround 2. Created an unprecedented development programme to catapult DTG’s success 30% 25% Global Quarterly Growth 20% 15% 10% 5% 0%
Slide 9: ViiV Healthcare success to date: Second Phase 2013-Today
ViiV Healthcare success to date has evolved in two phases – Second Phase: 2013 - Today 2013 Emerging Leadership: market growth and innovation Today 1) DTG success fuelling ViiV Healthcare growth 2) Commitment to true innovation that delivers real patient benefit Split of ViiV Healthcare sales since
Slide 10: The HIV market
The HIV market
Slide 11: 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 12: A highly dynamic market
A highly dynamic market HIV market valued at £16 billion in 2015 Reported reason for patients switching to a new therapy as reported by physicians (N=246) Dynamic Segment ~15-35% of the market per year 1% Simplification 3% 2% Toxicity 8% 4% Clinical trial inclusion 32% Virological failure 6% Drug-dr
Slide 13: The market has been receptive to innovation and remains a strong opportunity for growth
The market has been receptive to innovation and remains a strong opportunity for growth £16B £12.7B Tivicay Prezista Isentress 3rd agents £5.4B Isentress 3rd agents £5.0B Prezista Sustiva Triumeq STRs Atripla Atripla STRs Stribild £5.9B Genvoya Odefsey £3.5B Complera NRTI backbone £4.1B Epzicom/Kive
Slide 14: Guideline updates drive market evolution
Guideline updates drive market evolution 2013 2014 2015 2016 October 2013 DHHS October November 20142013 recommends November 2015 integrase July 2016 DHHS inhibitor-based EACS added DTG regimens including WHO added DTGDTG IAS recommends + Epzicom/Kivexa +Epzicom or +Truvadaas alternative first for A
Slide 15: We have now entered the integrase inhibitor era
We have now entered the integrase inhibitor era INIs represent 46% of the TRx market, a figure that will continue to grow Core Agent share of US TRxs INI dynamic (Core Agents only, STRs allocated to Core Agent class) share >70% Atripla Tivicay in the US and 100% Isentress Complera Stribild Triumeq G
Slide 16: Dolutegravir
Viiv Healthcare Dolutegravir
Slide 17: Amongst integrase inhibitors, DTG stands out
Amongst integrase inhibitors, DTG stands out Unprecedented and unmatched clinical Unique product characteristics trial results efavirenz Rapid and potent antiviral activity raltegravir darunavir atazanavir dolutegravir SUPERIOR SUPERIOR SUPERIOR SUPERIOR Drug-Drug interactions (DDIs) High barrier
Slide 18: Dolutegravir leads the market as the #1 core agent
Dolutegravir leads the market as the #1 core agent Weekly US TRx market share (STR + core agent) – since Tivicay launch 30% 25% DTG total 19.7% 20% Competitor franchise 17.7% 15% Competitor franchise 15.6% 10% Competitor Franchise 9.1% 5% 0% Source: IMS data to 2 September 2016 18 #1 meaning most pr
Slide 19: And the #1 agent in dynamic share in the US
And the #1 agent in dynamic share in the US New* Patient Shares by Product Switch/Add Patient Shares by Product 30% (STR+Core agent) 60% (STR+Core agent) DTG total EXCLUDING conversions1 25% 27% 50% Competitor DTG total 38% franchise 20% 22% 40% Competitor franchise 15% 30% 34% Triumeq 13% Triumeq 2
Slide 20: Already #1 agent in dynamic share in many other key markets
Already #1 agent in dynamic share in many other key markets # 1 in Naïve # 1 in Switch France Germany Italy Spain UK Canada Japan Sources: 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) 20 #1 meaning mo
Slide 21: ViiV Healthcare is the only company with increasing growth in HIV
ViiV Healthcare is the only company with increasing growth in HIV over the past 12 months (from +34% to +53%) HIV Market Growth 12% 70% Global HIV market by value 60% MAT Market Share Competitor 1 £9.1bn Key 54% MAT sales 50% +14% Market share MAT growth 40% ViiV Healthcare £3.1bn 30% 18% Competitor
Slide 22: R&D strategy
R&D strategy
Slide 23: Committed to innovation and leadership in HIV
Committed to innovation and leadership in HIV Search for Prevention Remission cabotegravir long-acting* and Cure Long-acting Treatment Regimens cabotegravir + rilpivirine* New MOA GSK3684934* previously Dolutegravir-based Regimens BMS-663068; attachment inhibitor Tivicay and Triumeq Maturation Inhib
Slide 24: 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 24
Slide 25: Why can 2-drug regimens (2DR) succeed?
Why can 2-drug regimens (2DR) succeed? DTG/CAB uniquely positioned for 2DRs Scientifically viable Encouraging clinical data Long term treatments with improved adverse event profile Unmet medical need Ageing HIV patient population with co-morbidities Persistent interest in 2DR research Market demand
Slide 26: ViiV Healthcare integrase inhibitors at the forefront of the 2DR paradigm shift
ViiV Healthcare integrase inhibitors at the forefront of the 2DR paradigm shift Establish DTG as the Challenge the three leading core agent in the market drug paradigm DTG+ DTG+ 3TC RPV CAB+ RPV LA 26
Slide 27: Cabotegravir LATTE and LATTE-2 Studies
Cabotegravir LATTE and LATTE-2 Studies Durable virologic suppression with oral and long-acting (LA) 2DR LATTE (oral CAB+RPV) LATTE-2 (LA inj. CAB+RPV) Week 96 Virologic Outcomes Week 48 Virologic Outcomes * Reference: Margolis et al, Lancet Inf Dis 2015;15(10):1145-1155 Margolis D et al., 21st IAC,
Slide 28: Investigator initiated 2DR studies
Investigator initiated 2DR studies PADDLE ASPIRE DOLATAV GARDEL SALT DUALIS LAMIDOL ACTG 5353 LPV/r+3TC ATV/r + 3TC DTG+ DRV/r DTG+ATV/r DTG+3TC LPV/r = lopinavir boosted with ritonavir ; DRV/r = darunavir boosted with ritonavir ; ATV/r = atazanavir boosted with ritonavir 28
Slide 29: DTG + RPV
DTG + RPV Phase III started May 2015 SWORD 1 and 2 Indication 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 30: DTG + 3TC
DTG + 3TC Phase III started August 2016 GEMINI 1 and 2 Indication 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 31: A growing body of evidence to support 2DR
A growing body of evidence to support 2DR 2016 2017 2018 INTERNAL STUDIES SWORD 1 & 2 ▲ GEMINI 1 & 2 ▲ ISS STUDIES* PADDLE 96 weeks ▲ ACTG 5353 ▲ ASPIRE ▲ DUALIS ▲ LAMIDOL ▲ DOLATAV ▲ Next available congress presentation = ▲ Forward-looking, dependant on data availability *ISS abstract are best esti
Slide 32: Why innovation should remain a priority in HIV
Why innovation should remain a priority in HIV Maturation Fusion inhibitor inhibitor Protease inhibitor CCR5 antagonis t Protease inhibitor Attachment RT inhibitor inhibitor Integrase Protease inhibitor inhibitor Reference: Lataillade et al. CROI 2015, Abstract 114LB 32
Slide 33: Concluding remarks
Viiv Il Healthcare Concluding remarks
Slide 34: Our strategic priorities to ensure near and long term success
Our strategic priorities to ensure near and long term success Continue to drive share in traditional 3 drug regimens through strength of DTG Create a new paradigm in oral treatment through 2DR Create a new paradigm in treatment through long-acting therapy Continue to lead HIV innovation with researc
Slide 35: Q&A
Q&A Healthcare
ViiV Healthcare — Goldman Sachs seminar on HIV and ViiV Healthcare (September 2016) on 6ix