GSK plc · LSE:GSK
GSK — Investor Day (October 2022)
36 slides from GSK's investor day presentation, Oct 21, 2022
Slide 1: Investor Science Event
21 October 2022 Investor Science Event Getting ahead of respiratory syncytial virus disease in older adults IDWeek 2022, 19 - 23, October 2022, Washington, DC Conference call and webcast for investors and analysts gsk.com
Slide 2: 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 3: Speakers
Speakers Dr Tony Wood Dr Phil Dormitzer Dr Michael G Ison Roger Connor Luke Miels Chief Scientific Officer SVP, Global Head, Professor of Medicine and President, Vaccines and Chief Commercial Officer Vaccines R&D Surgery Northwestern Global Health Medicine 3
Slide 4: Why we're here / Agenda
Why we’re here Agenda 01 02 Prevention of RSV disease in 03 AReSVi-006 phase III results Innovation leadership in vaccines older adults and potential impact Dr Tony Wood Dr Phil Dormitzer Dr Michael Ison 04 Commercial opportunity Q&A Roger Connor, Luke Miels 4
Slide 5: Innovation leadership in vaccines
21 October 2022 Innovation leadership in vaccines Dr Tony Wood, Chief Scientific Officer gsk.com 5
Slide 6: A new biopharma company
A new biopharma company Uniting science, technology, and talent to get ahead of disease together Infectious Immunology Opportunity HIV Oncology Diseases / Respiratory Driven* *Includes high-potential late-stage pipeline assets and internally/externally sourced assets consistent with R&D focus on the
Slide 7: Innovation in vaccines
Innovation in vaccines IDWeek 2022, 19-23 October 2022, Washington, DC Potential best-in-class clinical profile for novel RSV1 vaccine candidate in older adults • 94.1% reduction in severe RSV disease in older adults • 82.6% overall vaccine efficacy in older adults • Favourable safety profile • Co-a
Slide 8: RSV data: the highlight of strong year of vaccines R&D delivery
RSV data: the highlight of strong year of vaccines R&D delivery Exceptional Regulatory Advanced and consistent phase III results for approvals achieved including novel vaccine candidates to RSV1 vaccine candidate in older Priorix for MMR2 (US); Boostrix FTIH including mRNA flu; mRNA adults maternal3
Slide 9: RSV programme leveraged unique vaccines R&D capabilities
RSV programme leveraged unique vaccines R&D capabilities Focus on science of immune Advanced technology system to both treat and platforms are central to our prevent disease R&D approach • Leadership in infectious diseases • Proprietary adjuvanted RSV vaccine candidate, building • One capital alloca
Slide 10: Prevention of RSV in older adults
21 October 2022 Prevention of RSV in older adults Dr Phil Dormitzer, Senior Vice President and Global Head, Vaccines R&D gsk.com 10
Slide 11: Significant unmet medical need and disease burden
Significant unmet medical need and disease burden Currently, no vaccine or specific treatment for adults >1 billion aged 60+ at risk of annual exposure to RSV Common contagious virus 420k 29K Deaths • Hospitalisations • Older adults and those with underlying medical Developed countries Developed cou
Slide 12: Designing a potentially effective RSV vaccine for older adults
Designing a potentially effective RSV vaccine for older adults Vaccines R&D strategic priorities • Proteins +/- adjuvant • mRNA platform • MAPS/bacterial technology Hypothesis: combine viral surface antigen with adjuvant to deliver very high efficacy in older adults 12
Slide 13: RSV candidate vaccine for older adults
RSV candidate vaccine for older adults Designed to protect vulnerable adults against RSV disease RSVPreF3 antigen AS01E • Engineered to • Boosts cellular immune preferentially maintain the response and restores the pre-fusion conformation RSVPreF3 CD4+ T-cell level and display potent in older adults
Slide 14: Comprehensive clinical programme targeted to adults at greatest risk
Comprehensive clinical programme targeted to adults at greatest risk Phase Trial Population Comment Status Number of participants recruited into RSV older Phase I/II RSV OA=ADJ-002 Adults and older adults, First-in-human (Phase I) Safety, immunogenicity, formulation Complete adult vaccine candidate
Slide 15: AReSVi-006 phase III results and potential impact
201 October 2022 AReSVi-006 phase III results and potential impact Dr Michael Ison, Professor of Medicine and Surgery, Northwestern Medicine gsk.com 15
Slide 16: Methods: Ongoing, phase 3, randomized, placebo-controlled study
Methods: Ongoing, phase 3, randomized, observer-blind, placebo-controlled, multi-country study (NCT04886596) RSV season 1 RSV season 2 RSV season 3 RSV_annual group Re-randomized (1:1) RSVPreF3 group N=12,467 Randomized (1:1) D1 D31 RSV_1dose group Placebo group Older adults N=12,499 ≥60 YOA D1 D31
Slide 17: Results: Demographic characteristics were similar between groups
Results: Demographic characteristics were similar between groups Age group (%) Sex (%) Race or ethnic group (%) ≥80 years Other Black or African 8.2 Female 4.5 8.5 American 8.2 60–69 years 4.1 8.8 7.6 7.6 70–79 years Asian 48.0 51.4 35.9 55.9 36.0 55.8 48.6 52.0 79.5 Male White 79.3 Comorbidi�es of
Slide 18: Results: The primary endpoint was demonstrated
Results: The primary endpoint (vaccine efficacy against RSV-LRTD) was demonstrated Number of events RSVPreF3 Placebo N=12,466 N=12,494 71.71 82.6 RSV-LRTD* Primary endpoint# 7 40 94.1 0 20 40 60 80 100 Vaccine efficacy (%, 96.95% CI) *An event meeting the case definition of LRTD (Presence of: ≥2 low
Slide 19: Results: Single dose highly efficacious against full spectrum of RSV disease
Results: A single dose of RSVPreF3 OA is highly efficacious against the full spectrum of RSV disease, from RSV-ARI to severe RSV-LRTD Number of events RSVPreF3 Placebo N=12,466 N=12,494 71.7 RSV-ARI 27 95 82.6 RSV-LRTD Primary endpoint 7 40 94.1 Severe* 1 17 RSV-LRTD 0 20 40 60 80 100 Vaccine effica
Slide 20: Results: Consistently high VE regardless of RSV subtype
Results: Consistently high VE was observed regardless of RSV subtype Number of events RSVPreF3 Placebo N=12,466 N=12,494 84.6 RSV-A 2 13 RSV-LRTD 80.9 RSV-B 5 26 71.9 9 32 RSV-A RSV-ARI 70.6 RSV-B 18 61 0 20 40 60 80 100 Vaccine efficacy (%, 95% CI) N, number of participants in the mES. RSV etiology
Slide 21: Results: High VE across different age groups
Results: High VE against RSV-LRTD was seen across different age groups Number of events/N RSVPreF3 Placebo 82.6 ≥60 years 7/12,466 40/12,494 81.0 60–69 years 4/6963 21/6979 93.8 70–79 years 1/4487 16/4487 0 20 40 60 80 100 Vaccine efficacy (%, 96.95 or 95% CI) Note: VE in adults ≥80 years was inconc
Slide 22: Results: Robust immune response to RSV-A and RSV-B regardless of age
Results: Robust immune response to RSV-A and RSV-B regardless of age RSV-A NAb RSV-B NAb 12800 12800 6400 6400 3200 3200 GMT (ED60, 95% CI) GMT (ED60, 95% CI) 1600 1600 800 800 400 400 200 200 100 100 60–69 70–79 ≥80 60–69 70–79 ≥80 N=447/432 N=329/313 N=109/103 N=447/432 N=329/313 N=109/103 Age gro
Slide 23: Results: High VE in participants with comorbidities and pre-frail and fit
Results: High VE against RSV-LRTD was observed in participants with pre-existing comorbidities and in pre-frail and fit participants Number of events/N RSVPreF3 Placebo 72.5 comorbidities No comorbidity By baseline 6/7529 22/7633 of interesta ≥1 comorbidity 94.6 of interesta 1/4937 18/4861 80.0 5/74
Slide 24: Results: High VE over median follow-up of 6.7 months
Results: High VE against RSV-LRTD was observed over the median follow-up period of 6.7 months, supporting efficacy over the course of an RSV season RSV-LRTD RSV-ARI 0.010 Placebo 0.008 Cumulative incidence 0.006 0.004 RSVPreF3 0.002 0.000 0 1 2 3 4 5 6 7 8 9 10 11 Time from day 15 post-vaccination,
Slide 25: Results: RSVPreF3 OA was well tolerated
Results: RSVPreF3 OA was well tolerated, and most solicited AEs were mild or moderate and resolved within the 4-day solicitation period (mean duration: 1–2 days) Percentage of participants with solicited AEs (SSS, N=1757) 100 Grade 1 60.9 Grade 2 80 46.9 Grade 3 13.0 1.0 Participants, % (95% CI) 60
Slide 26: Conclusions
Conclusions The primary endpoint was demonstrated A single dose of RSVPreF3 OA vaccine is highly efficacious in preventing RSV-ARI, RSV-LRTD and severe RSV-LRTD in adults ≥60 YOA over one RSV season Vaccine efficacy was similar against RSV-A and RSV-B subtypes and was consistently high in 60–69 and
Slide 27: What do these important data mean when addressing the burden of RSV disease?
What do these important data mean when addressing the burden of RSV disease? What do they mean for physicians and for older adults? 27
Slide 28: How did study investigators determine degree of severity of lower respiratory tract disease?
How did study investigators determine degree of severity of lower respiratory tract disease? 28
Slide 29: What was the rationale for the clinical study design?
What was the rationale for the clinical study design, specifically with an end point focused on adults with comorbidities? 29
Slide 30: Commercial opportunity
21 October 2022 Commercial opportunity Roger Connor, President Vaccines and Global Health Luke Miels, Chief Commercial Officer gsk.com 30
Slide 31: A long history of innovation leadership
A long history of innovation leadership Vaccine leadership Driving innovative vaccines sales £m1 High single-digit • c.70-year history of vaccine development (introduced % CAGR polio vaccines in 1950s) • Broadest portfolio in the industry with 25 vaccines +10% CAGR1 supplied across 160 countries 6.3
Slide 32: Data at IDWeek 2022 further strengthen GSK's vaccines position
Data at IDWeek 2022 further strengthen GSK's vaccines position RSV OA1 data suggests potential to Shingrix duration data sets new standard for expand vaccine portfolio for elderly shingles prevention • Unprecedented high efficacy for 10 years Vaccines approved in growing OA segment • Unconstrained s
Slide 33: Data offers potential best-in-class profile in the most vulnerable adults
Data offers potential best-in-class profile in the most vulnerable adults Consistent high efficacy Reduction in severe Efficacy in those with Efficacy in those aged disease comorbidities 70-79 years 94.1% 94.6% 93.8% Key risk factors are age and comorbidities • Older adults at increased risk from RS
Slide 34: RSV OA vaccine candidate represents significant opportunity
RSV OA vaccine candidate represents significant opportunity Q4 2022: US FDA submission acceptance; EU regulatory submission Consistent high efficacy Substantial unmet need Launch readiness and offers a best-in-class profile and market opportunity long-term differentiation • 94.1% efficacy against •
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Slide 36: Case definitions for evaluation of vaccine efficacy
Confidential Case definitions for evaluation of vaccine efficacy Endpoint Case definition ARI (trigger for swabbing) Presence of: • at least two respiratory symptoms/signs for at least 24 hours OR • at least one respiratory symptom/sign + one systemic symptom/sign for at least 24 hours RSV-ARIa An e