1. 21st International AIDS Conference; July 18-22, 2016; Durban, South Africa 1 ViiV Healthcare, Research Triangle Park, NC, USA; 2 Ciudad Sanitaria y Universitaria de Bellvitge, Barcelona, Spain; 3 ICH Study Center, Hamburg, Germany; 4 Infektio Research, Frankfurt, Germany; 5 The Ottawa Hospital, Ottawa, Canada; 6 Fort Lauderdale, FL, USA; 7 Hospital Germans Trias i Pujol, Badalona, Spain; 8 Hospital General de Elche & Universidad Miguel Hernández, Alicante, Spain; 9 North Texas Infectious Disease Consultants, Dallas, TX, USA; 10 GlaxoSmithKline, Mississauga, Ontario, Canada; 11 PAREXEL International, Research Triangle Park, NC, USA; 12 Janssen Research and Development, Beerse, Belgium Cabotegravir + Rilpivirine as Long-Acting Maintenance Therapy: LATTE ‑ 2 Week 48 Results David A. Margolis, 1 Daniel Podzamczer, 2 Hans-Jürgen Stellbrink, 3 Thomas Lutz, 4 Jonathan B. Angel, 5 Gary Richmond, 6 Bonaventura Clotet, 7 Felix Gutierrez, 8 Louis Sloan, 9 Sandy K. Griffith, 1 Marty St Clair, 1 David Dorey, 10 Susan Ford, 11 Joseph Mrus, 12 Herta Crauwels, 12 Kimberly Y. Smith, 1 Peter E. Williams, 12 William R. Spreen 1

2. 21st International AIDS Conference; July 18-22, 2016; Durban, South Africa Dr. David A. Margolis is an employee of ViiV Healthcare Disclosures Margolis et al. AIDS 2016; Durban, South Africa. Abstract THAB0206LB.

3. 21st International AIDS Conference; July 18-22, 2016; Durban, South Africa CAB is an HIV-1 integrase inhibitor – Oral 30 mg tablet (t ½, ~40 hours) – LA nanosuspension 200 mg/mL (t ½, ~20-40 days) RPV is an HIV-1 NNRTI – Oral 25 mg tablet (t ½, ~50 hours) – LA nanosuspension 300 mg/mL (t ½, ~30-90 days) Oral 2-drug CAB + RPV proof of efficacy through Week 96 in LATTE-1 Background Margolis et al. AIDS 2016; Durban, South Africa. Abstract THAB0206LB. 12168 4BL2 242628 32 36 40 48 60 72 84 96 Proportion, % (95% CI) BL, baseline; CAB, cabotegravir; CI, confidence interval; EFV, efavirenz; LA, long-acting; NNRTI, non-nucleoside reverse transcriptase inhibitor; RPV, rilpivirine; t ½, half-life. Margolis et al. Lancet Infect Dis. 2015;15:1145-1155.

4. 21st International AIDS Conference; July 18-22, 2016; Durban, South Africa Establish proof of principle for the first ever long-acting (LA) injectable HIV treatment regimen Primary Objectives – Evaluate the safety and efficacy of CAB LA + RPV LA as maintenance therapy – Select a dosing schedule of CAB LA + RPV LA for progression into phase III studies Key Secondary Objectives – Characterize pharmacokinetics after depot injections – Evaluate the tolerability and acceptability of intramuscular dosing LATTE-2 Objectives Margolis et al. AIDS 2016; Durban, South Africa. Abstract THAB0206LB.

5. 21st International AIDS Conference; July 18-22, 2016; Durban, South Africa Induction period LATTE-2 Study Design Week 32 Primary analysis Dosing regimen selection Day 1 Randomization 2:2:1 Week 48 Analysis Dosing regimen confirmation CAB 400 mg IM + RPV 600 mg IM Q4W (n=115) CAB 600 mg IM + RPV 900 mg IM Q8W (n=115) Week 96 b CAB loading dose at Day 1 CAB loading doses at Day 1 and Week 4 CAB 30 mg + ABC/3TC for 20 weeks CAB 30 mg + ABC/3TC PO QD (n=56) CAB 30 mg + ABC/3TC PO QD for 20 weeks (N=309) Maintenance period a Add RPV PO QD 4 weeks Inclusion criteria >18 years old Naive to antiretroviral therapy CD4+ >200 cells/mm 3 Exclusion criteria Positive for hepatitis B ALT ≥5 × ULN Creatinine clearance <50 mL/min Qualification for maintenance HIV-1 RNA <50 c/mL between Week -4 and Day 1 Margolis et al. AIDS 2016; Durban, South Africa. Abstract THAB0206LB. ABC/3TC, abacavir/lamivudine; ALT, alanine aminotransferase; IM, intramuscular; PO, orally; QD, once daily; Q4W, every 4 weeks; Q8W, every 8 weeks; ULN, upper limit of normal. a Subjects who withdrew after at least 1 IM dose entered the long-term follow-up period. b Subjects can elect to enter Q4W and Q8W LA Extension Phase beyond Week 96.

6. 21st International AIDS Conference; July 18-22, 2016; Durban, South Africa Baseline Characteristics: ITT-ME Population Margolis et al. AIDS 2016; Durban, South Africa. Abstract THAB0206LB. Q8W IM (n=115) Q4W IM (n=115) Oral CAB (n=56) Total (N=286) Median age, years35.036.035.0 Female, n (%)8 (7)6 (5)10 (18)24 (8) African American/African heritage, n (%)17 (15)12 (10)15 (27)44 (15) CDC class C, n (%)1 (<1)2 (2)03 (1) Median HIV-1 RNA, log 10 c/mL4.44.54.34.4 ≥100,000, n (%)16 (14)28 (24)7 (12)51 (18) Median CD4+, cells/mm 3 449.0499.0517.5489.0 CDC, Centers for Disease Control and Prevention; ITT-ME, intent-to-treat maintenance exposed.

7. 21st International AIDS Conference; July 18-22, 2016; Durban, South Africa LATTE-2 Week 48 Results: HIV-1 RNA <50 c/mL by Snapshot (ITT-ME) Margolis et al. AIDS 2016; Durban, South Africa. Abstract THAB0206LB. Snapshot success D1W32 Q4W99%94% Q8W95% Oral98%91% Proportion of patients with virological suppression, % BLW-16W-12W-8D1W4W8W12W16W20W24W28W32 Study visit Induction period Maintenance period W-4W36 W40 W44W48 Oral CAB induction (ME population)Oral CAB (n=56)Q4W IM (n=115)Q8W IM (n=115)

8. 21st International AIDS Conference; July 18-22, 2016; Durban, South Africa HIV-1 RNA <50 c/mL at Week 48 ITT-ME (Snapshot) Margolis et al. AIDS 2016; Durban, South Africa. Abstract THAB0206LB. a Met prespecified threshold for concluding IM regimen is comparable to oral regimen (Bayesian Posterior Probability >90% that true IM response rate is no worse than -10% compared to the oral regimen). Observed Bayesian Probabilities: Q8W vs Oral = 99.7%; Q4W vs Oral = 99.4%. OralIM Virologic outcomesTreatment differences (95% CI) -6.612.4 Q8W IM -7.6 11.6 Q4W IM Both Q8W and Q4W comparable to Oral CAB at Week 48 a

9. 21st International AIDS Conference; July 18-22, 2016; Durban, South Africa Snapshot Outcomes: HIV-1 RNA <50 c/mL at Week 48 (ITT-ME) Margolis et al. AIDS 2016; Durban, South Africa. Abstract THAB0206LB. Week 48 outcome Q8W IM (n=115) Q4W IM (n=115) Oral CAB (n=56) Virologic success 106 (92%)105 (91%)50 (89%) Virologic non-response 8 (7%)1 (<1%)1 (2%) Data in window not <50 c/mL a 6 (5%)1 (<1%)0 Discontinued for lack of efficacy 1 (<1%)01 (2%) Discontinued for other reason while not <50 c/mL 1 (<1%) b 00 No virologic data in window 1 (<1%)9 (8%)5 (9%) Discontinued due to adverse event or death c 06 (5%)2 (4%) Discontinued for other reasons d 1 (<1%)3 (3%)3 (5%) a Week 48 HIV-1 RNA Q8W: 50 c/mL, 57 c/mL, 97 c/mL, 110 c/mL, 135 c/mL, 463/205 c/mL; Q4W: 59 c/mL; Q8W: 5 of 6 remain in the study, 4 of 6 have HIV-1 RNA <50 c/mL at all subsequent visits through W80. b Withdrew consent: intolerability of injections. c Q4W: hepatitis C, rash, depression, psychosis, epilepsy, and Churg-Strauss vasculitis; oral CAB: hepatitis C, DILI. d Q8W: ISR; Q4W: pregnancy, prohibited medication, relocation; oral CAB: lost to follow-up, relocation, withdrew consent (wanted injections rather than oral tablets).

10. 21st International AIDS Conference; July 18-22, 2016; Durban, South Africa NNRTI—K103N, E138G, and K238T ( FC RPV=3.3; Etravirine=1.9 ); INI—Q148R ( FC CAB=5.1; Dolutegravir=1.38 ) c No additional PDVFs beyond W48 on any arm (all subjects through W72) d Protocol-Defined Virologic Failure (PDVF): Genotype Margolis et al. AIDS 2016; Durban, South Africa. Abstract THAB0206LB. Maintenance period a Q8W IM (n=115) Q4W IM (n=115) Oral CAB (n=56) Subjects with PDVF2 (1%) b 01 (2%) INI-r mutations1c1c 00 NRTI-r mutations000 NNRTI-r mutations1c1c 00 PDVF: 0.5 log 10 c/mL increase from nadir HIV-1 RNA value ≥200 c/mL. a One additional PDVF without treatment-emergent resistance occurred during oral Induction Period due to oral medication non-adherence. b One PDVF at Week 4: no detectable RPV at Week 4 and Week 8, suggesting maladministration. c One PDVF at Week 48 at HIV- 1 RNA 463 c/mL (confirmed at 205 c/mL). d Contains data beyond W48.

11. 21st International AIDS Conference; July 18-22, 2016; Durban, South Africa Adverse Events and Labs— Maintenance Period Margolis et al. AIDS 2016; Durban, South Africa. Abstract THAB0206LB. AE, adverse event; ISR, injection-site reaction. a Q8W: influenza-like illness, chills and pain; Q4W: influenza-like illness, rash, depression, and psychosis. b one death (epilepsy). c Q8W: ISR, ISR/chills/body pain; Q4W: Churg-Strauss vasculitis, hepatitis C, depression, epilepsy, psychosis, rash, and mesenteric vein thrombosis; oral CAB: hepatitis C. d Maintenance emergent. ITT-ME population, n (%) Q8W IM (n=115) Q4W IM (n=115) Oral CAB (n=56) IM subtotal (N=230) Drug-related AEs, excluding ISRs (≥3%) Pyrexia3 (3)5 (4)08 (3) Fatigue2 (2)4 (3)1 (2)6 (3) Influenza-like illness3 (3)2 (2)05 (2) Headache2 (2) 2 (4)4 (2) Rash03 (3)03 (1) Grade 3 and 4 AEs, excluding ISRs 10 (9%)13 (11%)2 (4%)23 (10%) Drug-related Grade 3/4 AEs, excluding ISRs a 2 (2)4 (3)06 (3) Serious AEs (none drug related) 8 (7%)8 (7%) b 3 (5%)16 (7%) AEs leading to withdrawal c 2 (2%)7 (6%)1 (2%)9 (4%) Grade 3 and 4 labs d 18 (16)23 (20)9 (16)41 (18)

12. 21st International AIDS Conference; July 18-22, 2016; Durban, South Africa ISRs for CAB LA or RPV LA Over Time Bars represent incidence of onset ISR events relative to the most recent IM injection visit. Subjects at visit Q8W IM 115 115 114 113 113 113 113 112 112 112 112 112 111 Q4W IM 115 115 115 114 112 111 109 109 108 107 106 105 104 Day 1 W 4 W 8 W 12 W 16 W 20 W 24 W 28 W 32 W 36 W 40 W 44 W 48 Weeks Overall ISR AE Incidence 99% of ISRs were mild (82%) or moderate (17%), and 90% resolved within 7 days Most common ISR events overall were pain (67%), nodules (7%), and swelling (6%) 2/230 subjects (<1%) withdrew as a result of injection reactions (Q8W) Margolis et al. AIDS 2016; Durban, South Africa. Abstract THAB0206LB.

13. 21st International AIDS Conference; July 18-22, 2016; Durban, South Africa Patient-Reported Outcomes at Week 48: Maintenance Treatment a Margolis et al. AIDS 2016; Durban, South Africa. Abstract THAB0206LB. Note: based on observed case data set of subjects who completed Week 48 questionnaires. a HIV Treatment Satisfaction Questionnaire status version (HIVTSQs). How satisfied are you with your current treatment? 1%4% 1% How satisfied would you be to continue with your present form of treatment? 1% 8% 1% 2% very satisfiedvery dissatisfied 6 5 4 3 2 1 0

14. 21st International AIDS Conference; July 18-22, 2016; Durban, South Africa Pharmacokinetics Margolis et al. AIDS 2016; Durban, South Africa. Abstract THAB0206LB. Cτ, trough concentration; PA-IC90, protein binding–adjusted 90% inhibitory concentration; SD, standard deviation. Both Q4W and Q8W steady state exposures approximate once-daily oral dosing

15. 21st International AIDS Conference; July 18-22, 2016; Durban, South Africa LATTE-2 results successfully demonstrate ability to maintain HIV-1 viral load <50 c/mL with IM CAB + RPV LA, dosed every 4 or 8 weeks Three subjects met PDVF criteria during maintenance – Q8W (n=2), oral CAB (n=1); one Q8W subject with emergent RPV and CAB resistance Injection tolerability – Majority of ISRs were Grade 1 to 2 pain, with a median duration of 3 days – Few subjects had an ISR that led to discontinuation – High overall reported satisfaction Dose selection – Q4W dosing resulted in lower rates of virologic non-response with similar safety to Q8W – Q4W dosing was selected for pivotal phase III studies – Q8W dosing remains under evaluation within LATTE-2 Conclusions Margolis et al. AIDS 2016; Durban, South Africa. Abstract THAB0206LB.

16. 21st International AIDS Conference; July 18-22, 2016; Durban, South Africa We thank everyone who has contributed to the success of the study – All study participants and their families – The LATTE-2 clinical investigators and their staff in Spain, Germany, France, Canada, and the United States – The ViiV Healthcare, GlaxoSmithKline, PAREXEL, and Janssen study team members LATTE-2 was sponsored by ViiV Healthcare Acknowledgments Margolis et al. AIDS 2016; Durban, South Africa. Abstract THAB0206LB.

17. 21st International AIDS Conference; July 18-22, 2016; Durban, South Africa Backup

18. 21st International AIDS Conference; July 18-22, 2016; Durban, South Africa Visit Subject 144696222291551 (PDVF) BL 230,63488,33379,6821851046883444,489 W-16 11268576749 W-12 54<40 4585/<4058 W-8 79<40 51 W-4 4675/48<40 46 Day 1 <40 59<4055 W4 5141<40 W8 <40 W12 <40 W16 <40 51 W20 43<40 W24 <40 W28 <4052<4027952<40 W32 <4070<40<40/91<40 W36 <40 7381<40 W40 <4077<4010388<40 W44 <40 72100<40 W48 501355797110463/205 W56 <40 5793 W64 <40 53<40 W72 <4090<40 W80 <40144<40 Q8W: HIV-1 RNA for W48 HIV-1 VL >50 c/mL (Snapshot) 4 of 6 with HIV-1 RNA >50 c/mL at W48 remain suppressed through W80 a a Contains data beyond W48; Updated 11 JUL 2016. Margolis et al. AIDS 2016; Durban, South Africa. Abstract THAB0206LB.

19. 21st International AIDS Conference; July 18-22, 2016; Durban, South Africa LATTE-2 Subject 551—W48 PDVF vs. Q8W Dosing— Plasma Concentrations Margolis et al. AIDS 2016; Durban, South Africa. Abstract THAB0206LB. 0 4 8 12 16 20 2428 32 36 40 44 48 Mean plasma CAB ± SD, µg/mL Mean plasma RPV ± SD, ng/mL Cτ, trough concentration; PA-IC90, protein binding–adjusted 90% inhibitory concentration; Q8W, every 8 weeks; SD, standard deviation. 0 4 8 12 16 20 2428 32 36 40 4448 Week

20. 21st International AIDS Conference; July 18-22, 2016; Durban, South Africa Most common ISR events overall were pain (67%), nodules (7%), and swelling (6%) The number of subjects reporting ISRs decreased over time, from 86% (Day 1) to 29% (Week 48) a 2/230 subjects (<1%) withdrew as a result of ISRs (Q8W) Injection-Site Reactions— Maintenance Period Margolis et al. AIDS 2016; Durban, South Africa. Abstract THAB0206LB. a Represents percent of subjects with a Week 48 visit (n=215). Q8W IM (n=115) Q4W IM (n=115) IM subtotal (N=230) Number of injections212635855711 Number of ISRs127515682843 Grades Grade 1 1017 (80%)1321 (84%)2338 (82%) Grade 2 245 (19%)234 (15%)479 (17%) Grade 3 12 (<1%)10 (<1%)22 (<1%) Grade 4000 Duration, days ≤7 1135 (89%)1414 (90%)2549 (90%) Median3.0

21. 21st International AIDS Conference; July 18-22, 2016; Durban, South Africa Day 1 Induction Outcomes (ITT-E) Margolis et al. AIDS 2016; Durban, South Africa. Abstract THAB0206LB. Day 1 Snapshot outcome Oral CAB (N=309) Virologic success282 (91%) Virologic non-response14 (5%) Data in window not <50 c/mL9 (3%) Discontinued for lack of efficacy 2 (<1%) Discontinued for other reason while not <50 c/mL 3 (<1%) No virologic data in window13 (4%) Discontinued due to AE or death 6 (2%) Discontinued for other reasons 7 (2%) Day 1 drug-related AEs Oral CAB (N=309) Preferred term ≥3% Nausea27 (9%) Dyspepsia9 (3%) Headache9 (3%) Fatigue8 (3%) ITT-E Snapshot <50 c/mL 91%

22. 21st International AIDS Conference; July 18-22, 2016; Durban, South Africa Arthralgia Injection-site nodule Insomnia Influenza Injection-site erythema Anxiety Back pain Pyrexia Injection-site pruritus Injection-site pain Gastroenteritis Headache Syphilis Abdominal pain Upper respiratory tract infection Gonorrhoea Injection-site bruising Pharyngitis Injection-site induration Injection-site warmth Bronchitis Diarrhoea Nasopharyngitis Injection-site swelling Respiratory tract infection Anogenital warts Cough Fatigue Influenza-like illness Common On-Treatment Maintenance Period AEs (≥5% in Any Arm): Q8W vs Q4W Relative risk with 95% CI Favors Q8WFavors Q4W Percent Q4W IM (n=115) Q8W IM (n=115) 0 1.0 16.0 Adverse events Margolis et al. AIDS 2016; Durban, South Africa. Abstract THAB0206LB.