Gsk Plc · LSE:GSK
Gsk — Investor Day (September 2019)
45 slides from Gsk's investor day presentation, Sep 26, 2019
Slide 1: Vaccines: Meet the management
Vaccines Meet the management 26 September 2019
Slide 2: Roger Connor
Roger Connor President, GSK Vaccines
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: Agenda
Agenda GSK Vaccines priorities Roger Connor President, GSK Vaccines Dr. Emmanuel Hanon Vaccines R&D approach Senior VP, Vaccines R&D Russell Thirsk Manufacturing expertise VP Site Operations Roger Connor Summary President, GSK Vaccines Q&A: Jay Green, Senior VP, Finance Patrick Desbiens, Senior VP,
Slide 5: Attractive market dynamics
Attractive market dynamics Attractive Growing and ageing population Expanding and demographics Increasing vaccination rates durable market Long product No ‘patent cliffs’ lifecycles Large initial capital Limited number of global players investment Long development Could take up to 10-20 years to bri
Slide 6: Market evolving: expanding disease areas and target groups across the life course
Market evolving: expanding disease areas and target groups across the life course Vaccines tomorrow Potential for advances in technologies and Vaccines today therapeutic New vaccines for approaches Older adults adults / adolescents Early 2000s Increased clinical Mainly paediatric differentiation Min
Slide 7: GSK Vaccines: strong track record of performance
GSK Vaccines: strong track record of performance Global vaccines turnover (£m) Strong margin 5,894 12% CER CAGR progression 5,160 from 2015 – 2018 25% to 33%1 4,592 3,657 Novartis integration US market share ~£400m cost from 14% to 24%2 savings over 3 years Recent high value 27% of Rx/Vx launches: S
Slide 8: Focus on delivering Vaccines priorities
Focus on delivering Vaccines priorities Innovation Performance Trust • Design and deliver • Focus on priority assets • Deliver on-time supply ground-breaking vaccines • Target key markets • Ensure quality • Leverage disruptive • Drive growth, operating standards technologies performance and cash • S
Slide 9: GSK Vaccines pipeline
Innovation GSK Vaccines pipeline Phase 1 / 2 Phase 2 Phase 3 RSV older adults * COPD * Shingrix immuno-compromised * RSV maternal * RSV paediatric Bexsero paediatric (US) Therapeutic chronic hepatitis B MenABCWY MMR (US) Recent Menveo liquid 1 Clostridium difficile Rotarix liquid (PCV free 2) start
Slide 10: Shingrix: a new standard of prevention in shingles
Innovation Shingrix: a new standard of prevention in shingles Risk of shingles increases as immune Unprecedented clinical profile with system function declines upside opportunities >90% efficacy across identified age groups 99.5% Key risk factors: Increasing age Sustained efficacy of adults ≥50 year
Slide 11: Shingrix: US launch driving market expansion
Innovation Shingrix: US launch driving market expansion Share uptake superior to recent Significant US opportunity remains benchmarked biopharma launches 100 Shingrix Received at least first 90 ~9m1 80 dose of Shingrix Chronic Hep C Market Share (%) 70 60 Relapsing MS Potential revaccination ~23m2 5
Slide 12: Shingrix: global opportunity to expand the market as capacity increases
Innovation Shingrix: global opportunity to expand the market as capacity increases over time Large global opportunity >1% of eligible 50+ population estimated to have received Shingrix • New facility Lifecycle • Broad geographic management • Phased launch into China expansion • Focused geographic In
Slide 13: Bexsero: leading the market in Meningitis B
Performance Bexsero: leading the market in Meningitis B Invasive Meningococcal B Strong sales growth Launched in 34 markets disease Incidence and serotype distribution varies Growing global sales1 EU: Strong competitive by region; most common serogroup is US: 70% share of growing differentiation wit
Slide 14: Broad portfolio with quarterly sales fluctuations
Performance Broad portfolio with quarterly sales fluctuations Products Regions 1,924 1,924 304 1,585 1,585 1,479 1,522 1,479 1,522 329 235 193 209 1,060 1,238 1,253 1,238 1,253 286 188 666 778 180 184 357 386 777 110 167 221 489 486 402 377 389 393 339 403 939 1,005 941 947 885 877 374 462 436 406 4
Slide 15: Established vaccines and flu: durable assets provide portfolio backbone
Performance Established vaccines and flu: durable assets provide portfolio backbone Strategic lifecycle management enables a durable, cash generative portfolio Hepatitis franchise £808m in 2018 DTP franchise1 £1,197m in 2018 • Supply agility created • Hexa competition in Europe; opportunities expect
Slide 16: Our supply reliability, safety and quality
Trust Our supply reliability, safety and quality Strong history, experience, capabilities World class manufacturing capabilities Strong regulatory track record Technical competence Supply stability and reliability 16
Slide 17: Value of vaccines for public health
Trust Value of vaccines for public health Vaccines offer tremendous impact 2-3m $150bn x44 Deaths prevented Benefit of vaccines Estimated return on every year by to low and middle investment of the vaccination1 income countries cost of over next decade2 immunisation3 Our vaccines make meaningful con
Slide 18: GSK: The market leader in vaccines
GSK: The market leader in vaccines Strong history and Pipeline with un-rivalled expertise technology platforms Strong topline growth Broad portfolio and margin progression Geographic spread Manufacturing expertise 18
Slide 19: Innovation is key
Innovation is key Vaccines turnover (£m) 7,000 6,000 5,000 4,000 Pandemrix®* 3,000 2,000 1,000 0 2000 2002 2004 2006 2008 2010 2012 2014 2016 2018 Note: New product launches have contributed to the growth shown, but there may also be additional factors to take into account. 19 * 2008 – 2010 trendlin
Slide 20: Dr. Emmanuel Hanon
Dr. Emmanuel Hanon Head of R&D, GSK Vaccines
Slide 21: GSK history of vaccines leadership and innovation
Innovation GSK history of vaccines leadership and innovation 1986 2000 2018 1950s Partnership Start of World’s first Major advance with Gavi production of recombinant in tuberculosis oral polio hepatitis B initiated 2006 2015 vaccine 2019 vaccine First fully-liquid First human vaccine First successf
Slide 22: Vaccines innovation trends
Innovation Vaccines innovation trends Life science revolution Prophylactic driven by insights and data vaccines Prophylactic New technologies Therapeutic vaccines vaccines Lifecourse Novel partnership opportunities Immunisation 22
Slide 23: Our vaccines R&D approach
Innovation Our vaccines R&D approach Design and deliver ground-breaking vaccines • Shingrix and meningitis portfolio (Lifecycle management) • Key development assets: RSV, COPD • Therapeutic vaccines, antimicrobial resistance Leverage disruptive technologies • Improve vaccine efficacy • Make manufact
Slide 24: Classification of pipeline assets in clinical testing
Innovation Classification of pipeline assets in clinical testing Innovative assets Marketed assets Commercial assets Global Health assets Lifecycle management Addressing commercially- Science-based, New presentations, relevant disease areas sustainable, focused on indications, or geographic impact e
Slide 25: GSK Vaccines pipeline
Innovation GSK Vaccines pipeline Commercial assets Global Health assets Lifecycle management Phase 1 / 2 Phase 2 Phase 3 RSV older adults * COPD * Shingrix immuno-compromised * RSV maternal * RSV paediatric Bexsero paediatric (US) Therapeutic chronic hepatitis B MenABCWY MMR (US) Recent start Clostr
Slide 26: RSV vaccine opportunity: high unmet need
Innovation RSV vaccine opportunity: high unmet need Target protection against RSV across all ages with high burden • Burden highest in young children and older adults • 177,000 hospitalisations and 14,000 deaths in older adults RSV-associated hospitalisation Disease • Around half of hospitalisation
Slide 27: Three RSV vaccine candidates
Innovation Three RSV vaccine candidates All with FDA fast track designation and key data in 2020 US market potential Status Design Read out (individuals) FDA fast track maternal ~4m annual birth Phase 1/2 Ongoing Safety, reactogenicity and immunogenicity of 1 dose IM injection in healthy non-pregnan
Slide 28: COPD: therapeutic vaccine candidate designed to reduce exacerbations
Innovation COPD: therapeutic vaccine candidate designed to reduce exacerbations Causes of COPD exacerbations • COPD affects 10% of the world’s population aged over 40 • 3rd largest cause of mortality worldwide (3.1 million deaths in Disease 2015) No infection / Bacteria burden • US: ~16 million affe
Slide 29: Scientific expertise opens new fields in vaccines R&D
Innovation Scientific expertise opens new fields in vaccines R&D Therapeutics Global disease burden Technology approach Goal Status Chronic >250m Viral vector & recombinant Functional cure (HBsAg and FTIH patients hepatitis B adjuvanted proteins HBV DNA elimination) H2 2019 887,000 annual deaths Ant
Slide 30: Advances in platform technologies are the foundation for vaccines innovation
Innovation Advances in platform technologies are the foundation for breakthrough vaccines innovation Adjuvant systems Reverse vaccinology Improve efficacy Adenoviral vectors Faster, simpler and more efficient development & manufacturing Bioconjugation SAM (self-amplifying mRNA) 30
Slide 31: Adjuvant systems – a technology evolution
Innovation Adjuvant systems – a technology evolution Enhance immune responses to antigens for increased efficacy Adjuvant Substance to enhance and modulate the immune response to vaccine antigen(s) Enhanced Adjuvanted immune Vaccine Antigen response Molecular structure that can be recognised by the
Slide 32: GSK leadership in adjuvant systems
Innovation GSK leadership in adjuvant systems Shingrix is a prime example of the power of our adjuvant systems Adjuvant base Immuno-enhancers Adjuvant systems Fendrix Aluminium Cervarix MPL AS04 salts Pandemrix Oil/water Vitamin E AS03 emulsions (tocopherol) Shingrix Liposome QS-21 MPL malaria AS01
Slide 33: GSK Vaccines pipeline: AS01 key to future priorities
Innovation GSK Vaccines pipeline AS01 key to future priorities Commercial assets Global Health assets Lifecycle management Phase 1 / 2 Phase 2 Phase 3 RSV older adults * AS01 COPD * AS01 Shingrix immuno-compromised * AS01 RSV maternal * RSV paediatric Bexsero paediatric (US) Therapeutic chronic hepa
Slide 34: SAM Technology (self-amplifying mRNA)
Innovation SAM Technology (self-amplifying mRNA) Antigen production inside the body, by the body Lipid nanoparticle Inject Amplification SAM mRNA engine Manufacture SAM in a cell-free system • Native antigen • Non-replicating Antigen Subunit Immune expression • Antigen sequence response 34
Slide 35: SAM Platform – a technology revolution
Innovation SAM Platform – a technology revolution Current technologies • Shorter lead times for each candidate Faster discovery • High throughput screening of many candidates • Faster transfer and scale up • Independent from biological manufacturing processes – SAM-based Simpler manufacturing vaccin
Slide 36: Vaccines R&D priorities
Innovation Vaccines R&D priorities Priorities Pipeline progress – COPD Start of clinical studies Accelerate key pipeline assets – RSV First trials in humans Strategic lifecycle – Shingrix immuno-compromised – Therapeutic hepatitis B vaccine candidate: H1 2019 management – Meningitis – Clostridium di
Slide 37: Russell Thirsk
Russell Thirsk Head of Belgium Operations, GSK Vaccines
Slide 38: Vaccines differ from small molecule drugs
Trust Vaccines differ from small molecule drugs Vaccines Non-biological drugs Implications More sophisticated Complex with various core Typically a single active Composition manufacturing components1 chemical component1,5 and testing required Higher risk tolerance Cost and time requirements, Regulat
Slide 39: Vaccines manufacturing journey
Trust Vaccines manufacturing journey Quality control: 70% of total production time Manufacturing Raw Bulk antigen Coupling, Lot release, packaging Regulator Distribution infrastructure material manufacturing formulation, and shipment batch release • preparation reception filling • construction • val
Slide 40: Example: Shingrix production process
Trust Example: Shingrix production process Lead time: 8 – 12 months Bulk Formulation Fill Pack gE purified bulk Antigen QS21 QS21 powder liquid bulk Adjuvant MPL Concentrated powder liposomes bulk 40
Slide 41: Sites and batches - stringent quality testing
Trust Sites and batches - stringent quality testing Manufacturing sites are approved and Each batch undergoes repeated, regularly inspected rigorous quality testing US FDA Manufacturer's release EMA Europe WHO pre-qualification Reference country review, test, release National Regulatory Authorities
Slide 42: GSK Vaccines manufacturing capability
Trust GSK Vaccines manufacturing capability Strong history, experience, capabilities World class manufacturing capabilities Strong regulatory track record Technical competence Supply stability and reliability 42
Slide 43: Roger Connor
Roger Connor President, GSK Vaccines
Slide 44: GSK Vaccines are positioned for success, growth and differentiation
GSK Vaccines are positioned for success, growth and differentiation for a very long time Innovation Design and deliver ground-breaking vaccines Attractive Leverage disruptive technologies growing market Foster partnerships Topline growth Durable with Performance Focus on priority assets Strong margi
Slide 45: Q&A
Q&A Roger Connor Jay Green President, GSK Vaccines Senior VP, Finance Dr. Emmanuel Hanon Patrick Desbiens Senior VP, Vaccines R&D Senior VP, Commercial Russell Thirsk Thomas Breuer VP Site Operations Chief Medical Officer