Gsk Plc · LSE:GSK
Gsk — Investor Day (November 2016)
90 slides from Gsk's investor day presentation, Nov 29, 2016
Slide 1: GSK Vaccines meet the management
GSK Vaccines meet the management 29 November 2016
Slide 2: Contents
Contents Agenda Presenter biographies Presentations Investor Relations UK +44 (0)20 8047 5557 US +1 215 751 4611 2
Slide 3: Agenda
Agenda Luc Debruyne Thomas Breuer Emmanuel Hanon John McGrath Q&A President Chief Medical Head of R&D Head of Global GSK Vaccines Officer GSK Vaccines Industrial GSK Vaccines Operations GSK Vaccines 3
Slide 4: Luc Debruyne
Luc Debruyne President, GSK Vaccines Luc was appointed President, Global Vaccines in 2013. Following the successful integration of the Novartis vaccines business acquired in early 2015, GSK Vaccines delivers today a broad portfolio of more than 30 paediatric, adolescent, adult/travellers and elderly
Slide 5: Thomas Breuer
Thomas Breuer Chief Medical Officer, GSK Vaccines Thomas Breuer is GSK Vaccines Chief Medical Officer. He leads the global medical affairs organisation, safety and pharmacovigilance, and patient access functions such as health economics. He is a member of the management team of GSK Vaccines. From 20
Slide 6: Emmanuel Hanon
Emmanuel Hanon Head of Research & Development, GSK Vaccines Emmanuel leads our vaccines research and development organisation, covering discovery, early and late-stage development, regulatory and medical affairs activities. He is based in Rixensart, Belgium. Emmanuel joined GSK Vaccines in 2001 taki
Slide 7: John McGrath
John McGrath Head of Global Industrial Operations, GSK Vaccines John McGrath has been involved with the biologics industry for over twenty five years since graduating from Dublin City University in Ireland. In that time he has held various technical and management positions in Ireland, the UK, the U
Slide 8: Strategic overview
Strategic overview Luc Debruyne President, GSK Vaccines
Slide 9: Cautionary statement regarding forward-looking statements
Cautionary statement regarding forward-looking statements This presentation contains statements that are, or may be deemed to be, “forward-looking statements”. Forward-looking statements give the Group’s current expectations or forecasts of future events. An investor can identify these statements by
Slide 10: The value of vaccination
The value of vaccination Widely recognised as one of the best investments in healthcare Tremendous progress for global health… …but still underserved populations ~3m ~22m deaths infants still prevented missing annually: basic ~5 per minute vaccines Target populations are growing… …and major diseases
Slide 11: Vaccines benefit all phases of life
Vaccines benefit all phases of life Adolescent, adult Paediatric and travel Older adult Maternal 11
Slide 12: Multiple drivers of the need for vaccines
Multiple drivers of the need for vaccines Examples of industry wide focus areas, including vaccines under development Poverty Emerging Travellers Chronic Therapeutic • Cholera infections • Hepatitis diseases vaccines • Malaria • Ebola • Rabies • Flu • Autoimmune • Parasitic • West Nile • Yellow feve
Slide 13: Vaccines is an attractive business, with barriers to entry
Vaccines is an attractive business, with barriers to entry Growing market: Pharma-like Long product ~£18bn in 20151 Few global operating lifecycles, expected to players margins no patent cliff grow at 5%2 Complex Depth of Large capital manufacturing expertise across investment & quality control valu
Slide 14: Value and volume based business model
Value and volume based business model Two distinct markets ‘Quarterly’ volatility the norm 100% Tenders Government • Wins stockpiles 75% • Timing • Replenishments • Funding • Withdrawals • Pricing 50% Public Private Seasonality Supply 25% • Back to school • GSK • Flu season • Competitors 0% • Outbre
Slide 15: GSK Vaccines is an ambitious global leader
GSK Vaccines is an ambitious global leader Helping to improve health around the world Broadest portfolio in the industry Helping to protect more people 39 ~2 million vaccines approved, covering every doses per day demographic Continuously delivering new Strategy to deliver sustainable and improved v
Slide 16: The Novartis transaction complemented our strengths
The Novartis transaction complemented our strengths Acquired portfolio Innovation Supply chain Including meningitis Pipeline assets and Ownership of diphtheria platform technologies & tetanus antigens People US Network of highly skilled Helping to unlock US experts in R&D, potential manufacturing &
Slide 17: GSK is well positioned in US, Europe and International
GSK is well positioned in US, Europe and International 2016 vaccines sales for top four companies: September YTD GSK £1,245m Pfizer Pfizer Pfizer GSK £1,157m GSK USA Merck Europe Int Sanofi £1,053m Merck Sanofi Sanofi Merck 50-60% of global market 15-20% of global market 25-30% of global market Sour
Slide 18: Strong growth for GSK in US, Europe and International
Strong growth for GSK in US, Europe and International 9 month sales to September 2016 International US £1,157m £1,245m +17% +13% 2016 YTD: £3.5bn +16% CER pro-forma Other Vaccines £541m Europe £1,053m +18% All growth rates are at CER and pro-forma: i.e. adjusted for the Novartis transaction. 18
Slide 19: Strong growth across most franchises
Strong growth across most franchises 9 month sales to September 2016 £577m £550m pro-forma +6% XX% is below 94% -11% £444m £445m £382m +74% +1% £351m £363m £343m +43% +60% +4% +18% 2016 YTD: £3.5bn +16% CER pro-forma Boostrix Flu Rotarix Synflorix Meningitis Hepatitis Infanrix, Other Pediarix vaccin
Slide 20: On track to deliver vaccines sales growth targets
On track to deliver vaccines sales growth targets* Expected CAGR 2016-20* Expected growth drivers Mid-to-high ~1/3 ~1/3 ~1/3 single of growth from: of growth from: of growth from: digit sales Marketed Meningitis Shingrix growth* portfolio portfolio candidate vaccine Shingrix is an investigational ca
Slide 21: On track to deliver improved margin expectations
On track to deliver improved margin expectations* ~22% Core operating margin 2014 pro-forma Improved leverage from sales growth (CoGS, SG&A and disciplined R&D investments) Transaction cost savings ~£400m by 2017 Maintain CapEx investments Overall vaccines margin 30%+ by 2020** *Core results are def
Slide 22: Innovative R&D programmes aim to deliver sustainable growth
Innovative R&D programmes aim to deliver sustainable growth to 2020 and beyond New vaccines 3 − COPD − Technology platforms Longer term R&D focus 2 − Lifecycle management − RSV − GBS Near/mid term key R&D focus − Lifecycle management 1 − Meningitis − Shingrix candidate vaccine GBS=Group B Streptococ
Slide 23: Positioned to be global leader for a very long time
Positioned to be global leader for a very long time Strategic focus Reliable Focus on Bolster sustainable US approvals innovation supply & success pipeline Build Flawless broader execution talent pool 23
Slide 24: Portfolio strength & growth drivers
Portfolio strength & growth drivers Thomas Breuer Chief Medical Officer, GSK Vaccines
Slide 25: GSK's strong vaccines portfolio
GSK’s strong vaccines portfolio Adolescent, adult Paediatric and travel Older adult Diphtheria Cervical cancer (HPV) Diphtheria Haemophilus influenzae type b Diphtheria Hepatitis A (Hib) Haemophilus influenzae type b Hepatitis B Hepatitis A (Hib) Influenza (pre-pandemic flu) Hepatitis B Hepatitis A
Slide 26: GSK's strong vaccines portfolio
GSK’s strong vaccines portfolio Adolescent, adult Paediatric and travel Older adult Maternal** Diphtheria Diphtheria Cervical cancer (HPV) Diphtheria Influenza (flu) Haemophilus influenzae type b Diphtheria Hepatitis A Pertussis (Hib) Haemophilus influenzae type b Hepatitis B Poliomyelitis Hepatitis
Slide 27: Vaccine product lifecycle is a lifelong endeavor
Vaccine product lifecycle is a lifelong endeavor No patent cliff – no generics – each vaccine a unique entity Pre-licensure Post-licensure R&D* Product lifecycle Discovery New indications R&D Combinations Co-administration Age extensions Different dosing schemes Impact / effectiveness Technical impr
Slide 28: Flu vaccines: from trivalent to quadrivalent
Flu vaccines: from trivalent to quadrivalent Lifecycle example Trivalent (TIV) licensed in 1998 Quadrivalent (QIV) licensed in 2012 3 strains 4 strains A1 & * A1 A2 & * B1 ** B A2 ** & B2 28 * e.g. A/H1N1, A/H3N2 - ** e.g. B/Victoria, B/ Yamagata
Slide 29: Flu vaccines: from trivalent to quadrivalent
Flu vaccines: from trivalent to quadrivalent Lifecycle example Trivalent (TIV) licensed in 1998 Quadrivalent (QIV) licensed in 2012 3 strains 4 strains A1 B & * A1 A2 & * B1 ** B A2 ** & B2 29 * e.g. A/H1N1, A/H3N2 - ** e.g. B/Victoria, B/ Yamagata
Slide 30: Flu vaccines: from trivalent to quadrivalent
Flu vaccines: from trivalent to quadrivalent Lifecycle example Trivalent (TIV) licensed in 1998 Quadrivalent (QIV) licensed in 2012 3 strains 4 strains A1 & * A1 A2 & * B1 ** B A2 ** & B2 Competitive differentiation total revenue increase 2012-2015: 46%*** * e.g. A/H1N1, A/H3N2 - ** e.g. B/Victori
Slide 31: Rotarix: continuous label & technical improvements since initial licensure
Rotarix: continuous label & technical Lifecycle example improvements since initial licensure (2004) Thermostability Impact data* data Rotarix co- Lowering cost administration of goods** Rotarix growth since 2009: CAGR ~ 15%*** * Morbidity/Mortality, Health budget - ** e.g. fully liquid presentation,
Slide 32: Rotarix: impact on diarrhoea-related deaths in Mexico
Rotarix: impact on the number of diarrhoea-related deaths in Mexico1 Mexico: Countrywide vaccines introduction in May 2007 Decline in overall diarrhoeal death 2 No of diarrhoeal deaths between 45-55% (versus baseline) 1 2 Among children aged <5 years in Mexico according to age group 0-11 mo 12-23 mo
Slide 33: Rotarix: introduction of Universal Mass Vaccination in UK
Rotarix: introduction of Universal Mass Vaccination in infants in UK (2013) UK: 1 80% reduction in rotavirus gastroenteritis No of laboratory reports hospitalisations in infants2 (1)Public Health England. Norovirus and rotavirus: summary of surveillance. Available at 33 :https://www.gov.uk/governmen
Slide 34: Infanrix (DTPa) franchise: expanded combinations and indications
Infanrix (DTPa) franchise: expanded combinations Lifecycle example and indications (from 3-in-1 to 6-in-1) Infanrix™ (DTPa) Infanrix™ hexa (DTPa, IPV, HBV/Hib) Infanrix™ Infanrix™ Pediarix™ for the US Kinrix™ for the US 4-in-1 5-in-1 (DTPa-HBV-IPV) (DTPa-IPV) combos* combos** 1994 1996 1997 2000 200
Slide 35: Infanrix (DTPa) franchise: boosting vaccines added
Infanrix (DTPa) franchise: expanded combinations Lifecycle example and indications (adding vaccines aimed for boosting) Infanrix™ (DTPa) Infanrix™ hexa (DTPa, IPV, HBV/Hib) Infanrix™ Infanrix™ Pediarix™ for the US Kinrix™ for the US 4-in-1 5-in-1 (DTPa-HBV-IPV) (DTPa-IPV) combos* combos** 1994 1996
Slide 36: GSK Vaccines sales growth ambition by 2020
GSK Vaccines sales growth ambition by 2020 ~1/3 ~1/3 ~1/3 of growth from: of growth from: of growth from: Marketed Meningitis Shingrix portfolio portfolio candidate vaccine Shingrix is an investigational candidate vaccine for shingles that has been submitted for approval to the FDA and other authori
Slide 37: Meningococcal meningitis
Meningococcal meningitis
Slide 38: Meningococcal disease: uncommon, yet progresses rapidly
Meningococcal disease: uncommon, however progresses rapidly with unpredictable outcome Incidence and diagnosis Meningococcal disease incidence peaks in infants and adolescents Early signs and symptoms often resemble those of common viral illnesses1 Significant morbidity and mortality Despite appropr
Slide 39: Broad meningitis vaccines portfolio, including candidate pentavalent
Broad meningitis vaccines portfolio*, including candidate pentavalent MenveoTM BexseroTM MenABCWY** – MenACWY tetravalent vaccine – MenB vaccine – Candidate pentavalent combination vaccine – Approved in 64 countries – Approved in 38 countries – US & EU (2010) – EU from > 2 months – Currently in phas
Slide 40: UK infant effectiveness data major milestone for Bexsero
cksep16 UK infant effectiveness data major milestone for Bexsero FirstFirst country to start a public UMV program 83%83% effectiveness, effectiveness, cases cases halved, halved, >600k country to introduce Bexsero >600k infants vaccinated infants vaccinated 40
Slide 41: Excellent execution of Bexsero's launch
ckoct16 Excellent execution of Bexsero’s launch Strong performance globally Doses sold since launch cumulative (millions) 15 Cumulative volume 10 >10 million in 2 years Novartis Investing to expand 5 Vaccines integration capacity to capture market growth over time 2014 2015 2016 41 Source: GSK inter
Slide 42: GSK shingles candidate vaccine
GSK shingles candidate vaccine In regulatory approval process
Slide 43: Epidemiology of shingles/herpes zoster in the US
Epidemiology of shingles/herpes zoster (HZ) in the US The most important risk Feared complication ~ 1m cases in the US 32% 50% of persons living factors Increasing age Postherpetic estimated lifetime neuralgia annually1 risk of zoster1 over age 85 years Immunosuppression are likely to develop zoster
Slide 44: Shingrix candidate vaccine developed to differentiate
Shingrix candidate vaccine developed to differentiate Ambition at the outset: • Sub-unit vaccine (non-live) • High efficacy in 50+, including older subgroups • Sustained efficacy over time • Applicable to immunocompromised individuals • Refrigerator stable Shingrix is an investigational candidate va
Slide 45: Two dose vaccine: strong efficacy across different age groups
Two dose vaccine: strong efficacy across different age groups ZOE-50 / pooled ZOE-50 / ZOE-70 results Age range (years) Cases VACCINE GROUP Cases PLACEBO GROUP VE (95% CI) Efficacy against HZ (ZOE 50)* ≥50 6 210 97.2 (93.7-99.0) Efficacy against HZ (pooled ZOE 50/ZOE 70) ** ≥70 25 284 91.3 (86.8-94.
Slide 46: High and sustained efficacy over 4 years
High and sustained efficacy over 4 years Pooled ZOE-50 and ZOE-70 results HZ/Vaccine group Placebo group n=8,250 n=8,346 Time post-vaccination* HZ cases HZ cases VE (95% CI)† 97.6 Year 1 2 83 (90.9-99.8) 92.0 Year 2 7 87 (82.8-96.9) 84.7 Year 3 9 58 (69.0-93.4) 87.9 Year 4 7 56 (73.3-95.4) Cunningha
Slide 47: Safety and reactogenicity profile
Safety and reactogenicity profile ZOE-50/70 results* Safety: Reactogenicity: Second-dose compliance: No imbalance between - Local and systemic High: ~95% vaccine and reactions were common, placebo group for: however majority were of - Serious Adverse Events - mild to moderate intensity - Potentially
Slide 48: Key milestones on track
Key milestones on track Filing completed in US, Canada and Europe 2016 2017 2018 – c US, Canada, EU filings Japan filing Additional co-administration data Revaccination of people previously vaccinated with Zostavax* Phase III efficacy study in immuno-compromised * Zostavax is a trademark of Merck &
Slide 49: Shingrix candidate vaccine: the opportunity
Shingrix candidate vaccine: the opportunity… Globally only a small proportion of the older adult population has received a shingles vaccine Redefine and expand the market New standard Potential Increase Geographic New cohorts of prevention revaccination immunisation expansion opportunity* rates Immu
Slide 50: Research & Development
Research & Development Emmanuel (Manu) Hanon Head of R&D, GSK Vaccines
Slide 51: R&D organisation
R&D organisation Rixensart, Belgium Siena, Italy Rockville, MD, US 51
Slide 52: Vaccines R&D timelines (illustrative)
Vaccines R&D timelines (illustrative) Registration/ Identify Produce Pre-clinical Proof of Phase I Phase II Phase III File post-marketing antigens antigens testing concept surveillance Research (including immunology) Pre-clinical development (including formulation science) Clinical development (incl
Slide 53: Innovative R&D programmes aim to deliver sustainable growth
Innovative R&D programmes aim to deliver sustainable growth to 2020 and beyond New vaccines 3 − COPD − Technology platforms Longer term R&D focus 2 − Lifecycle management − RSV − GBS Near/mid term key R&D focus − Lifecycle management 1 − Meningitis − Shingrix candidate vaccine Shingrix is an investi
Slide 54: Respiratory Syncytial Virus (RSV)
Respiratory Syncytial Virus (RSV)
Slide 55: RSV-associated hospitalisation burden impacts infants and the elderly
RSV-associated hospitalisation burden significantly impacts infants and the elderly A. G. S. C. Jansen et al. Eur Respir J 2007;30:1158-1166 ©2007 by European Respiratory Society Respiratory syncytial virus-associated hospitalisation burden in the Netherlands. 55 : versus summer baseline period; : v
Slide 56: Novel RSV candidate vaccine approaches
Novel RSV candidate vaccine approaches The inclusion of RSV F (fusion) Site I protein in the composition of an Site Ø Site IV Site II RSV vaccine is critical Site II Pre-F Post-F Graham B et al., Current Opinion in Immunology 35; 30-38, 2015 56
Slide 57: Novel RSV candidate vaccine approaches
Novel RSV candidate vaccine approaches Absorption with Pre-F but not Post-F The inclusion Efficient RSV vaccine of RSV Frequires (fusion) Site I depletes neutralising IgG from the presence protein in the of composition RSV F protein of an in Site IV convalescent serum Site Ø Site II the right RSV va
Slide 58: Novel RSV candidate vaccine for the elderly
Novel RSV candidate vaccine for the elderly The inclusion Efficient RSV vaccine of RSV Frequires (fusion) the presence protein in the of composition RSV F protein of an in the right RSV vaccine conformation is critical GSK Pre-F approach differs from competitor Post-F which recently did not meet end
Slide 59: Novel RSV candidate vaccine for the elderly
Novel RSV candidate vaccine for the elderly Elderly candidate with AS01 The inclusion Efficient RSV vaccine of RSV Frequires (fusion) the presence protein in the of composition RSV F protein of an in Expected to enter late stage the right RSV vaccine conformation is critical development in 2020 GSK
Slide 60: Period of most severe RSV cases for young infants
Period of most severe RSV cases for young infants occurs from birth to 12 months 35,000 30,000 US Hospitalisations 25,000 20,000 15,000 10,000 5,000 0 0-2 3-5 6-8 9-11 12-14 15-17 18-20 21-23 mos mos mos mos mos mos mos mos 60 Paramore, Pharmacoeconomics 22:274-285, 2004
Slide 61: Two-pronged approach for infants
Period of most severe RSV cases for young infants occurs from birth to 12 months 35,000 Two-pronged approach for infants 30,000 US Hospitalisations Maternal vaccine Paediatric vaccine 25,000 20,000 Week of pregnancy Age in months 28 30 32 34 36 38 40 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 15,000 Mate
Slide 62: Maternal immunisation strategy to help prevent diseases in infants
Maternal immunisation strategy to help prevent diseases that afflict very young infants Infants protected by maternal flu vaccination 0.05 VE = 50.5% p = 0.01 – confirmed influenza – Proportion with Placebo Flu vaccine 0.00 0 2 4 6 Age (months) 62 GSK’s flu vaccines do not have approved indications
Slide 63: Novel RSV candidate vaccine approaches: maternal
Novel RSV candidate vaccine approaches Absorption with Pre-F but not Post-F Maternal The inclusion of RSV F (fusion) depletes neutralising IgG from convalescent serum Expect Phase III start: 2019 protein in the composition of an RSV vaccine is critical 100 90 % neutralising antibody GSK Pre-F approa
Slide 64: A different novel approach for paediatric
A different novel approach for paediatric Genetically engineered fibre recombinant CHAd155 Same vector used in core Ebola vaccine (Okairos transaction) Non-alum composition Double stranded DNA Target RSV genes Paediatric Expect Phase III start: post 2020 64
Slide 65: Group B Streptococcus (GBS)
Group B Streptococcus (GBS)
Slide 66: Maternal immunisation for GBS
Maternal immunisation for GBS The leading cause of No GBS disease GBS disease 40 pneumonia, meningitis and sepsis in neonates 35 30 1 in 2,500 of babies No infants contracted % infants 25 GBS disease with develop GBS disease maternal antibodies despite antibiotic 20 above this level prophylaxis of c
Slide 67: GBS maternal immunisation expanded programme
GBS maternal immunisation expanded programme Decision to expand composition to 1gG against serotypes 1a (µg/mL) 25 Vaccinated mothers Phase II trivalent Infants of vaccinated mothers pentavalent, to help protect against vaccine antibody data 20 Unvaccinated mothers and their infants >95% of prevalen
Slide 68: A new vaccine concept for COPD
A new vaccine concept for COPD
Slide 69: Role of microbes in acute exacerbations of COPD
Role of microbes in acute exacerbations of COPD Prevalence in acute Bacteria exacerbations of COPD Haemophilus 20-30% influenzae Moraxella catarrhalis 10-15% Streptococcus 10-15% pneumoniae Pseudomonas 5-10% mostly in advanced aeruginosa disease Adapted from Sethi S & Murphy TS N Engl J Med. 2008;35
Slide 70: Testing hypothesis for a COPD vaccine
Testing hypothesis for a COPD vaccine Non-typeable Haemophilus influenzae (NTHi) Moraxella catarrhalis (Mcat) PE serum resistance, adhesion, invasion UspA2 adhesion, PD serum serum resistance resistance, PilA adhesion motility and biofilm formation AS01 Proof of concept in humans 70 expected to be c
Slide 71: Unique expertise in platform technologies
Unique expertise in platform technologies Supports current and future pipeline Adjuvants 71
Slide 72: Unique expertise in platform technologies
Unique expertise in platform technologies Supports current and future pipeline Adjuvants Adenovirus Novel glyco- vector and conjugation Self-Amplifying RNA (SAM) 72
Slide 73: Vaccines Global Manufacturing Network
Vaccines Global Manufacturing Network John McGrath Head of Global Industrial Operations, GSK Vaccines
Slide 74: Quiz: time to manufacture a single dose
How long does it take to manufacture a single dose of vaccine? Options: A. Between 3 and 8 months QUIZ B. Between 6 and 12 months C. Between 6 and 18 months D. Between 10 and 26 months 74
Slide 75: Quiz: time to manufacture a single dose
How long does it take to manufacture a single dose of vaccine? Options: A. Between 3 and 8 months QUIZ B. Between 6 and 12 months C. Between 6 and 18 months D. Between 10 and 26 months 75
Slide 76: Quiz: percentage of children receiving a GSK vaccine
What percentage of the world’s children receive at least one GSK vaccine? Options: A. 10% QUIZ B. 20% C. 40% D. 50% 76
Slide 77: Quiz: percentage of children receiving a GSK vaccine
What percentage of the world’s children receive at least one GSK vaccine? Options: A. 10% QUIZ B. 20% C. 40% D. 50% 77
Slide 78: Quiz: percentage of countries receiving our vaccines
What percentage of the world’s countries receive our vaccines? Options: A. 50% QUIZ B. 70% C. 80% D. 90% 78
Slide 79: Quiz: percentage of countries receiving our vaccines
What percentage of the world’s countries receive our vaccines? Options: A. 50% QUIZ B. 70% C. 80% D. 90% 79
Slide 80: Our strong manufacturing network is a competitive advantage
Our strong manufacturing network is a competitive advantage: our people, buildings & processes Ability to navigate a complex regulatory environment Extensive capacity (~1bn doses/year) and investing to expand Able to respond to variability in short term demand Expertise in balancing supply and deman
Slide 81: Vaccines differ from medicines in many aspects
Vaccines differ from medicines in many aspects, from composition to development and administration Vaccines Non-biological drugs Typically a single active chemical Composition Complex with various core components1 component1,5 Large community-based trials Typically smaller clinical trials Trials in
Slide 82: A complex manufacturing journey
A complex manufacturing journey Raw material reception Bulk manufacturing and maturation 2 weeks3 2 weeks3 Patient safety and pharmacovigilance Patient safety and pharmacovigilance Quality control and assurance Quality control and assurance R&D Approval 10–30+ Day 0 years 70% of production time is M
Slide 83: Our global manufacturing network
Our global manufacturing network Saint-Amand-Les-Eaux Dresden Rixensart Moscow Ste Foy Wavre Tian Yuan (JV) Hamilton Hamilton Marburg Nashik Gödollö Shanghai Marietta Rosia/Siena Ankleshwar Singapore Key Global sites 83 Local sites
Slide 84: Shelf life management is critical
Shelf life management is critical What does it mean from a supply perspective? Example: vaccine with a 36 month shelf life Shelf life is 36 months from filling syringe or vial however, up to 1/3 of shelf life is used up before shipping +/- 18–26 months Manufacturing 1/3 of shelf life spent Remaining
Slide 85: For a vaccine available in 2019: when would manufacturing be initiated?
For a vaccine available in 2019: When would manufacturing be initiated?* 2016 2017 2018 2019 … H1 H2 H1 H2 H1 H2 Vaccines delivered to customers from Customer Q1 2019 Logistic chains filled from Q4 2018 Distribution (depending on the country) Packaging Specific leaflets and labels in 2018 Filling Se
Slide 86: Manufacturing sites are approved and regularly inspected by regulators
Manufacturing sites for vaccines are first approved and then regularly inspected by regulatory authorities EMA Europe US FDA1 (one member state RA)2 WHO pre-qualification3 National Regulatory Internal audits by Authorities4 Quality Assurance5 (e.g. Brazil, Japan) Frequent inspections4 EMA, European
Slide 87: Each vaccines batch undergoes repeated, rigorous quality testing
Each vaccines batch undergoes repeated, rigorous quality testing1,2 Country quality process GSK quality process Distribution to vaccine-recipient country Vaccine lot GMP compliance1 Vaccine-recipient country test2 QA Batch records1 Vaccine-recipient country laboratory tests and document review2 Lab
Slide 88: We are investing in capacity expansion
We are investing in capacity expansion Proactive upgrading of supply network Designed to meet Tackling recent and exceed supply constraints Ensure regulatory impacting HepA sustainability for requirements: and Pa containing the long term quality and vaccines current GMP 88
Slide 89: Our strong manufacturing network is a competitive advantage
Our strong manufacturing network is a competitive advantage: our people, buildings & processes Ability to navigate a complex regulatory environment Extensive capacity (~1bn doses/year) and investing to expand Able to respond to variability in short term demand Expertise in balancing supply and deman
Slide 90: Question & Answer session
om Question & Answer session