GSK plc · LSE:GSK
GSK — GlaxoSmithKline — Exane Conference 2009
35 slides from GSK's conference presentation, May 15, 2009
Slide 1: GSK: Delivering a Unique Vaccines Pipeline
GSK: DELIVERING A UNIQUE VACCINES PIPELINE Thomas Breuer, MD, MSc Senior Vice President Global Clinical R&D & Chief Medical Officer, GSK Biologicals
Slide 2: Today's Agenda
Today’s Agenda GSK GSK GSK GSK within within the the Vaccine Strategic Vaccines Vaccines Innovation Priorities Market Market
Slide 3: Vaccines Business Characteristics
Vaccines Business Characteristics Few Global Players and High Barriers to Entry – Complex Manufacturing – Large Scale Investment Long Product Life Cycles – Complex Intellectual Property High Probability of R&D Success – 70% post-POC New Technology/ Novel Products Better Pricing Operating Margin Comp
Slide 4: Global Vaccines Market 2008
Global Vaccines Market 2008 9% (£1,037 mn) 22% (£2,539 mn) 13% Others (£1,468 mn) GSK Wyeth 8% Novartis (£951 mn) Merck SPMSD 19% (£2,244 mn) Sanofi Aventis 9% (£1,019 mn) 20% (£2,271 mn) GSK estimates from consolidated 2008 Annual Reports
Slide 5: GSK Vaccines: Broad Geographic Opportunity
GSK Vaccines: Broad Geographic Opportunity Total Vaccines Market 2008* GSK Vaccines 2008 sales £11.5bn £2.5bn EU US 29% EU 26% US 43% 30% EU 48% Int'l Int’l 26% 28% *GSK estimates from consolidated 2008 Annual Reports
Slide 6: GSK Vaccines: Continuing Sales Growth
GSK Vaccines: Continuing Sales Growth Sales (£m) 17.1% CAGR 3000 since merger 2500 2000 1500 1000 500 0 2001 2002 2003 2004 2005 2006 2007 2008 Reported Annual Sales; CAGR at CER
Slide 7: GSK Vaccines in 2008
GSK Vaccines in 2008 Vaccines sales £2.5 billion (+15%) Vaccines represent 10.4% of GSK sales (2008) Approvals: US: Rotarix, Kinrix, Boostrix (adult) EU: Prepandrix, Pandemrix Increased International presence
Slide 8: Today's Agenda
Today’s Agenda GSK GSK GSK GSK within within the the Vaccine Strategic Vaccines Vaccines Innovation Priorities Market Market
Slide 9: Adjuvanted Vaccines – Immune Response
Adjuvanted Vaccines – Immune Response Adjuvanted vaccine Amplitude Non adjuvanted vaccine Time Adapted from Pulendran et al. Cell 2006; 124:849-863.
Slide 10: Why Do We Need Better Adjuvants?
Why Do We Need Better Adjuvants? To induce strong immune responses Malaria (complex disease) Hepatitis B vaccine for haemodialysed (immunosuppression), Fendrix™ Flu vaccine for elderly (weakened immunity) To induce long-term protection HPV vaccine, Cervarix™ To induce broader immune response: Cross-
Slide 11: Today's Agenda
Today’s Agenda GSK GSK GSK GSK within within the the Vaccine Strategic Vaccines Vaccines Innovation Priorities Market Market
Slide 12: GSK Strategic Priorities
GSK Strategic Priorities Grow a diversified global business Deliver more products of value Simplify the operating model
Slide 13: Grow a Diversified Global Business
Grow a Diversified Global Business United States Emerging Markets Diversification through growth of existing business & launch of new products Expanding Geographically
Slide 14: Grow a Diversified Global Business
Grow a Diversified Global Business Phase III File Marketed HibMenCY MenACWY Pre/pandemic New gen flu MAGE-A3 United UnitedStates States
Slide 15: Grow a Diversified Global Business: China
Grow a Diversified Global Business Licensed vaccines Infanrix, Infanrix-Hib, Boostrix, Fluarix, Engerix-B, Hiberix, Havrix, Twinrix, Priorix, Varilrix Vaccines in development Cervarix (phase III trials ongoing in China) Infanrix-IPV/Hib (IND) Joint venture with Neptunus (NIBT) in China Co-developmen
Slide 16: Grow a Diversified Global Business: Brazil
Grow a Diversified Global Business Over 25 year association with Brazilian Ministry of Health (Fiocruz) Long term governmental contracts Technology transfer agreements Oral polio vaccine (1980’s) Hiberix (1998) Priorix (2003) Rotarix (2008) Included in National Immunization Programme Brazil Brazil
Slide 17: Grow a Diversified Global Business: Tiered Pricing
Grow a Diversified Global Business Supranational high volume tenders GSK Bio pioneered tiered pricing over 20 years ago Pricing varies with Countries’ ability to pay volumes purchased duration of commitment This approach will also be used to increase the availability of new vaccines, including Rotar
Slide 18: Grow a Diversified Business
Grow a Diversified Business Immunotherapeutics for chronic disorders Immunotherapeutics for cancer Adolescent & Adult vaccines Paediatric vaccines
Slide 19: GSK Strategic Priorities
GSK Strategic Priorities Grow a diversified global business Deliver more products of value Simplify the operating model
Slide 20: A Rich Pipeline
A Rich Pipeline Phase I Phase II Phase III Submitted HIV Mosquirix Malaria Simplirix Herpes simplex virus Cervarix (BLA) Cervical cancer * S. pneumo adult Tuberculosis New generation flu Approved Cytomegalovirus Herpes zoster NTHi-Pneumo MAGE-A3 ASCI Flu Pre-pandemic * Non Small Cell Lung Dengue Can
Slide 21: Cervarix in 2009
Cervarix® in 2009 Continue to increase Cervarix coverage Now approved in 95 countries New launches Increase market share in existing markets Cervarix in the US Data submitted to FDA in March 2009 Final efficacy data from pivotal trial (HPV-008) Anticipate 6 month FDA review process New data Long-ter
Slide 22: Final Efficacy Analysis (HPV-008)
Final Efficacy Analysis (HPV-008) TVC naïve* (n=11,641) CIN2+ Approximates the primary target population for organized vaccination programs i.e. young women before sexual debut Vaccine type specific efficacy (CIN2+) HPV 16/18 (1/63) VE 98.4 (90.4-100) HPV 16 (1/56) VE 98.2 (89.1-100) HPV 18 (0/12) V
Slide 23: Final Efficacy Analysis (HPV-008)
Final Efficacy Analysis (HPV-008) TVC naïve (n=11,641), CIN2+ Vaccine efficacy against 5 most frequent oncogenic non- vaccine types (combined analysis) HPV 31/33/45/52/58 (15/47) VE 68.2 (40.5-84.1) Vaccine efficacy against 10 most frequent oncogenic non- vaccine types (combined analysis) HPV 31/33/
Slide 24: Head to Head: Cervarix vs. Gardasil (HPV-010)
Head to Head: Cervarix® vs. Gardasil™ (HPV-010) Rationale Immunogenicity data on the two vaccines cannot easily be compared because of differences in study design and assays used Gain insight into future potential differences in terms of long term protection 1,106 women (18 to 45 years) Primary endp
Slide 25: Head to Head: Cervarix vs. Gardasil (HPV-010)
Head to Head: Cervarix® vs. Gardasil™ (HPV-010) HPV 16 and 18 neutralizing antibody responses ATP Cohorts Women 18–26 years Women 27–35 years Women 36–45 years 3.7-fold 7.3-fold 4.8-fold 9.1-fold 2.3-fold 6.8-fold 100000 100000 100000 100000 100000 100000 GMT (ED50) 10000 10000 10000 10000 10000 100
Slide 26: Cervarix: a growing body of data
Cervarix®: a growing body of data What we know Major differences in measurable immune responses of Cervarix versus Gardasil neutralizing antibodies (serum) for each antigen in all age groups neutralizing antibodies at site of infection (cervix) higher HPV-16/18-specific B- and T-cell responses Stron
Slide 27: Synflorix: Approval and launch
EU Synflorix™: Approval and launch Approval March ‘09 3 additional serotypes (1, 5 & 7F) are associated with severe disease and high potential to cause infectious epidemics Potential to prevent up to 90 % of paediatric invasive pneumococcal disease in Europe Uniquely designed to target two major pat
Slide 28: Flu Vaccine Portfolio: Product Differentiation
Flu Vaccine Portfolio: Product Differentiation Seasonal flu vaccines – Life-cycle management FluaRix FluLaval Flu next generation (>65 years) – Phase III ongoing Pandemic vaccines – H5N1 Pandemrix Prepandrix – H1N1
Slide 29: Persistence of Cross-Reactive Neutralizing Antibodies
Persistence Of Cross-Reactive Neutralizing Antibodies - Seropositivity (%) A/Indonesia/5/05 A/turkey/Turkey/1/05 A/Anhui/1/05 Clade 2.1 Clade 2.2 Clade 2.3 100 Seropositivity (%) 80 60 40 20 0 3.8µg 3.8µg + AS 3.8µg 3.8µg + AS 3.8µg 3.8µg + AS Day 0 Day 42 Day 21 Day 180 Leroux-Roels et al. PlosOne
Slide 30: GSK Meningitis Portfolio & Pipeline
GSK Meningitis Portfolio & Pipeline Considerable disease burden – Bacterial meningitis causes permanent disability or death Fatality rate 9-12% Five serotypes responsible for majority of disease – A, B, C, W, Y Huge market potential GSK tailored meningitis vaccine portfolio – Menitorix (HibMenC) Mar
Slide 31: Antigen-Specific Cancer Immunotherapeutics (ASCI)
Antigen-Specific Cancer Immunotherapeutics (ASCI) Novel class of compounds based on tumour antigens MAGE-A3 in Non-Small Cell Lung Cancer (NSCLC) NSCLC is the most common form of lung cancer (80-85%) Positive phase II data 25 % reduction in the relative cancer recurrence following surgery at 44 mont
Slide 32: GSK Strategic Priorities
GSK Strategic Priorities Grow a diversified global business Deliver more products of value Simplify the operating model
Slide 33: Simplify the Operating Model
Simplify the Operating Model Simplify Manufacturing Manufacturing and Supply and Supply – Increase productivity – Reduce lead-time (then inventory) – Reduce variability Enhance commercial and market access Clinical R&D Simplification capabilities – Clinical Development Plan design Agenda Clinical –
Slide 34: GSK Vaccines in 2009
GSK Vaccines in 2009 GSK is a world leader in vaccines We develop vaccines that meet public health needs in both developed and developing countries (“emerging markets”) GSK has one of the strongest vaccine pipelines in the industry Over 20 vaccines in clinical development We expect GSK’s unique expe
Slide 35: GlaxoSmithKline
GlaxoSmithKline