HIV and ViiV Healthcare Dr Dominique Limet, Chief Executive Officer, ViiV Healthcare Dr John Pottage, Chief Scientific and Medical Officer, ViiV Healthcare
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
ViiV Healthcare vision
An ambitious vision Establish ViiV Healthcare as the leading company in the HIV market in innovation, sales and reputation 4
ViiV Healthcare history and operating model
A rich HIV history joined under a unique model ViiV Healthcare shareholding GSK (85%) 2009 and Pfizer (15%) create a joint venture dedicated to HIV treatments Shionogi (10%) 2012 The Japanese company becomes new partner and Highly reliant External support shareholder* from Pfizer and on GSK Strategy Shionogi Dolutegravir era infrastructure 2013 Drug discovery and First dolutegravir (DTG) development launch in the US R&D support Medical affairs R&D Marketing Manufacturing Manufacturing Sales Distribution ViiV Healthcare Public affairs 2016 (Alliance markets) acquires BMS’ HIV Global operations Administrative and pipeline and Resource management functional (HR, IT, discovery assets Performance management Legal, Finance) *Current shareholding of ViiV Healthcare: GSK 78.3%, Pfizer 11.7%, Shionogi 10% 6
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 working for employees working for ViiV planned, concluded and active GSK in R&D for ViiV Healthcare through shared clinical trials since creation, Healthcare service agreements including BMS acquisitions 7 *Alliance markets: Agreement with GSK in markets were ViiV Healthcare is not a legal entity
ViiV Healthcare success to date has evolved in two phases – First Phase: 2009 - 2013 Re-energised commercial operation and R&D 2009 2013 1. Led the Epzicom/Kivexa turnaround 2. Created an unprecedented development programme to catapult DTG’s success 30% Global Quarterly Growth 25% 20% 15% 10% 5% 0% -5% Source: GSK reported financial results 8
ViiV Healthcare success to date has evolved in two phases – Second Phase: 2013 - Today Emerging Leadership: market growth and innovation 2013 Today 1) DTG success fuelling ViiV Healthcare growth 2) Commitment to true innovation that delivers real patient benefit Split of ViiV Healthcare sales since 2009 Search for 2,500 Remission Prevention and Cure cabotegravir long-acting* 2,000 Sales in £m 1,500 Long-acting TreatmentRegimens cabotegravir + rilpivirine* New MOA 1,000 GSK3684934* previously BMS- Dolutegravir-based Regimens 663068; attachment inhibitor 500 Tivicay and Triumeq Maturation Inhibitors* Allosteric Integrase Inhibitors* Combinectin* 0 DTG 2-Drug Regimens 2009 2010 2011 2012 2013 2014 2015 Legacy ARV Drug Portfolio dolutegravir/rilpivirine* abacavir/lamivudine, dolutegravir/lamivudine* maraviroc & others Other products Epzicom New products Other products Epzicom/Kivexa New products Source: Reported Financial Results 9 * Note, therapies denoted with an (*) are investigational; safety and efficacy in treating/preventing HIV has not been established
The HIV market
The HIV epidemic remains a substantial challenge of our time 36.7 m people living with HIV worldwide 1 2.1m infections and 1.1m ADULTS WOMEN CHILDREN (<15 years) AIDS-related deaths per year globally 1 34.9 17.8 1.8 2.4m people living with HIV in Western and Central Europe and North America 1 million 1 million 1 million 1 Patients are living longer and infection rates have begun to rise again Treatment rate in developed markets is only 50-70% 2,3 IAS July 2016 recommends that all people living with HIV should receive treatment Source: 1. UNAIDS. Core epidemiology slides. June 2016; 2. IMS World Model Dec'15; 3. IMS local monthly model (Mar'16) 11
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 1% ~15-35% of the market per year Simplification 2% 3% Toxicity 8% 4% Clinical trial inclusion 32% Virological failure 6% Drug-drug interaction Initiation (naive) ~5-10% Patient decision 13% Lack of adherence Switch ~10-25% Pregnancy 31% Other Stable 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):19819 12
The market has been receptive to innovation and remains a strong opportunity for growth £16B £12.7B Tivicay Prezista 3 rd agents £5.4B Isentress Isentress 3 rd agents £5.0B Prezista Sustiva Triumeq STRs Atripla Atripla STRs £5.9B Genvoya Stribild Odefsey £3.5B Complera NRTI backbone £4.5B Epzicom/Kivexa NRTI backbone £4.1B Epzicom/Kivexa Descovy Truvada Truvada Generics Generics 2013 2015 Source: IMS MIDAS Database 13
Guideline updates drive market evolution 2013 2014 2015 2016 DHHS October 2013 recommends integrase October 2013 November 2014 November 2015 July 2016 inhibitor-based regimens including DTG DHHS EACS added DTG WHO added DTG IAS recommends + Epzicom/Kivexa +Epzicom or +Truvada as preferred for ART as alternative first recommends integrase inhibitor- or +Truvada for line treatment initial regimens naive patients based regimens ART naive patients consisting of an including DTG integrase +Epzicom or inhibitor plus two +Truvada as NRTIs preferred for ART naive patients 14
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 in the US and Tivicay Isentress Complera Stribild Triumeq Genvoya 100% Launch growing Launch Launch Launch Launch Launch Launch 90% 80% Odefsey 70% Launch 60% 50% 40% 30% 20% 10% 0% Protease inhibitors Non-nucleoside inhibitors Entry inhibitors Integrase inhibitors Source: IMS NPA Monthly Jul 2016 15
Dolutegravir
Amongst integrase inhibitors, DTG stands out Unprecedented and unmatched clinical Unique product characteristics trial results Rapid and potent antiviral activity efavirenz raltegravir darunavir atazanavir dolutegravir SUPERIOR SUPERIOR SUPERIOR High barrier to resistance SUPERIOR Drug-Drug interactions (DDIs) In vitro findings supported by Phase III (experienced) (naive) (women / naive) (naive) data Few clinically significant DDIs, Unboosted Long binding to DOLUTEGRAVIR wild type integrase NON INFERIOR Dissociation from mutant IN- DNA complexes slower vs RAL (naive) or EVG Well tolerated Breadth and depth Few discontinuations of clinical trial data elvitegravir/ SUPERIOR due to AEs in INI-naïve NON INFERIOR DTG superior vs EFV and DRV/r in clinical trials (women / naive) cobicistat treatment-naïve subjects and RAL in (naive) treatment-experienced subjects NON INFERIOR NON INFERIOR Long half-life; raltegravir (naive) low variability in exposure (naive) DTG (50 mg QD) exposures 19-fold above IC 90 SINGLE, FLAMINGO, SPRING 2, SAILING and ARIA were non-inferiority studies with a Long ‘tail’ - drug plasma concentrations pre-specified analysis for superiority up to 216h post dose Chart shows primary endpoint outcomes References: 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, et 17 al. 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 Agents Chemother 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 13
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 prescribed
And the #1 agent in dynamic share in the US New* Patient Shares by Product Switch/Add Patient Shares by Product (STR+Core agent) 30% 60% (STR+Core agent) DTG total EXCLUDING conversions 1 27% 25% 50% Competitor DTG total 38% franchise 20% 40% 22% Competitor franchise 34% 15% 30% Triumeq 13% Triumeq 21% Tivicay 10% 20% 13% 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, Stribild 19 to 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 th erapy RX in the last 12 months, and overstates true naïve volume slightly. Source: IMS NBRX Custom HIV Report 26 August 2016. #1 meaning most prescribed.
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