Slide 1: Cab la for prep: Superior efficacy
Cab la for prep: Superior efficacy CAB LA: cabotegravir long acting PrEP: Pre Exposure Prophylaxis CONFIDENTIAL INFORMATION – FOR INTERNAL USE ONLY The people depicted in this photo are models, for illustrative purposes only.
Slide 2: Welcome
WELCOME David Redfern Deborah Waterhouse Kimberly Smith MD, Chairman CEO Global Research & Development CONFIDENTIAL INFORMATION – FOR INTERNAL USE ONLY 2
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: Deborah Waterhouse, CEO
<= DEBORAH WATERHOUSE CEO
Slide 5: To Leave No Person Living With HIV Behind
TO LEAVE NO PERSON Living With HiV Behind CONFIDENTIAL INFORMATION – FOR INTERNAL USE ONLY The people depicted in this photo are models, for illustrative purposes only. 5
Slide 6: Helping End the HIV Epidemic
Helping End the hiv Epidemic The people depicted in this photo are models, for illustrative purposes only. 6
Slide 7: The HIV challenge
The hiv challenge 50% of Americans 38,000 new Particular challenge living with HIV are infections per amongst black and virally annum in US across Latino MSM key unsuppressed ethnicity spectrum populations US President Target to reduce strategy to end new infections by epidemic by 2030 75% within 5
Slide 8: The PrEP landscape worldwide
The PREP landscape worldwide • 200,000 people currently taking PrEP in US • US Government believes 1.2 million could benefit • Circa 500,000 MSM in Europe could benefit from PrEP US market value but barriers to access remain high Circa $2bn today • In Africa HIV infections are growing among adolesce
Slide 9: Kimberly Smith MD
Kimberly Smith MD Head of Research & Development 9
Slide 10: From Evolution to Revolution: The 2DR Era
FROM EVOLUTiON TO REVOLUTiON: THE 2DR ERA Current standard of care New treatment Search for remission HAART/legacy drugs paradigm = 2DR and cure Dolutegravir-based Two-drug regimens Prevention regimens Juluca: dolutegravir/rilpivirine cabotegravir long-acting* Tivicay Dovato: dolutegravir/lamivudine
Slide 11: Long Acting injectables - Giving a shot for treatment and prevention
LONG Acting injectables - Giving a shot for TREATMENT and prevention POTENTIAL INDICATIONS ➢ HIV treatment (long acting injectable) For virologically suppressed patients who would benefit from a HIV regimen which has the potential to reduce the emotional impact of HIV and its treatment on their dail
Slide 12: Cab la: Prep
Cab la: Prep
Slide 13: Cabotegravir long-acting for prevention (PrEP)
Cabotegravir long-acting for prevention (PrEP) • Event driven • Event driven; powered for superiority • Primary data presented at IAS • Primary data expected after 2020 • Sponsored by Division of AIDS, US National • Collaboration with NIH and Bill & Melinda Gates Institute of Allergy and Infectious
Slide 14: HPTN 083 Study Design
HPTN 083 Study Design • Phase 2b/3 randomized, double-blind, double-dummy @ 43 sites globally • MSM/TGW age 18+ • Risk: any nCRAI, >5 partners, stimulant drug use, incident rectal or urethral STI (or incident syphilis) in past 6 months; or SexPro Score ≤16 (US only) • Generally good health • No HBV
Slide 15: HPTN Study Design
HPTN 083 Study Design CAB TDF/FTC Landovitz RJ et al. AIDS 2020, #OAXLB01 15
Slide 16: Statistical Design: Efficacy
Statistical Design: Efficacy • Non-inferiority design • Non-inferiority margin 1.23 • Alternative hypothesis of HR 0.75 • Target background HIV Incidence ~4.5% • Anticipated TDF/FTC adherence by TFV plasma detectable ~67% • Endpoint-driven (172 events) with pre-specified interim analyses at 25%, 50%
Slide 17: HIV incidence: CAB vs. TDF/FTC
HiV incidence: CAB vs. TDF/FTC 52 HIV infections in 6389 PY of follow-up 1.4 (IQR 0.8-1.9) years median per-participant follow-up Pooled incidence 0.81 (95%CI 0.61-1.07) per 100 PY HIV Incidence Hazard Ratio (95% CI) 1.8 39 Infections 1.6 Favors CAB Favors TDF/FTC HIV Incidence Rate/100 PY 1.4 1.22
Slide 18: HIV incidence – ITT
HiV incidence – itt 1 year 2 years 3 years TDF/FTC Cabotegravir HR 0.34 (0.18, 0.62) p=0.0005 0 9 17 25 33 41 49 57 65 73 81 89 97 105 113 121 129 137 145 153 161 169 177 185 193 Weeks since enrollment Number at risk TDF/FTC 2247 2133 2081 2019 1913 1764 1624 1494 1294 1132 965 816 643 516 400 310 2
Slide 19: Results: HIV incidence in populations deemed most at risk
Results: hiv incidence in populations deemed most at risk Landovitz RJ et al. AIDS 2020, #OAXLB01 19
Slide 20: Injection site reactions
injection site reactions 47 (2.2%) CAB participants permanently discontinued injectable product due to an injection- related AE Severity of ISR was strongly associated with odds of permanent discontinuation Landovitz RJ et al. AIDS 2020, #OAXLB01 20
Slide 21: Conclusions
Conclusions • Investigational CAB LA administered every two months is 66% more effective than daily FTC/TDF pills in preventing HIV-1 acquisition • CAB LA was well tolerated, ISR more common on CAB vs FTC/TDF • Key subpopulations, such as BMSM, were well represented and demonstrate high effectivenes
Slide 22: Reaction
Reaction CONFIDENTIAL INFORMATION – FOR INTERNAL USE ONLY 22
Slide 23: Q&A
Q&A The person depicted in this photo is a model, for illustrative purposes only. CONFIDENTIAL INFORMATION – FOR INTERNAL USE ONLY