Gsk Plc · LSE:GSK
Gsk — GlaxoSmithKline — Investor Presentation (2010)
33 slides from Gsk's investor presentation, 2010
Slide 1: GSK Vaccines in 2010
GSK VACCINES IN 2010 Thomas Breuer, MD, MSc Senior Vice President Head of Global Vaccines Development GSK Biologicals
Slide 2: 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 for newer vaccines – H
Slide 3: Research & development timelines
Research & development timelines Identify Produce Pre-Clinical Proof of Registration/ Phase I Phase II Phase III File Antigens Antigens Testing Concept Post Marketing Research (inc. Immunology) Pre-Clinical Development (inc. Formulation Science) Clinical Development (inc. Post Marketing Surveillance
Slide 4: Global vaccines market 2009
Global vaccines market 2009 2009 total sales = Novartis 11.3% GSK 7 Pfizer/Wyeth 13.9% Merck 17.7% Sanofi- Aventis SP-MSD oe \S Total 2009 = $21,493m =) (— 2009 excluding H1N1 > Novartis 7.7% GSK Pfizer/Wyeth 16.2% Sanofi- Aventis SP-MSD ——o w 2009 excl. H1N1 = — GSK estimates from consolidated 2009
Slide 5: GSK vaccines business
GSK vaccines business 2009 sales £3.7 billion (+30%) +19% CAGR excl. H1N1 Vaccines represent 13% since 2005 of total GSK sales Sale s (£m) 4000 3500 Recent approvals: 3000 US: Cervarix 2500 EU: Synflorix 2000 Pandemic: Pandemrix; Arepanrix 1500 1000 500 0 2005 2006 2007 2008 2009 Increased Emerging
Slide 6: GSK vaccines: fastest growing part of GSK in 2009
GSK vaccines: fastest growing part of GSK in 2009 2009 Sales Share Growth (CER) Respiratory £ 6,977m 25% +5% Consumer £ 4,654m 16% +7% Anti-virals £ 4,150m 15% +12% Vaccines £ 3,706m 13% +30% CV & Urogenital £ 2,298m 8% +8% CNS £ 1,870m 7% -44% Anti-bacterials £ 1,592m 6% +2% Metabolic £ 1,181m 4% -
Slide 7: GSK vaccines: a history of growth
GSK vaccines: a history of growth £m 4000 86 3500 203 669 3000 65 2500 158 1004 85 462 2000 81 123 108 318 1500 78 700 294 106 259 667 1000 516 1744 364 1155 500 694 799 581 0 2005 2006 2007 2008 2009 Europe North America Emerging Markets APAC/Japan Other Note: All figures expressed at actual rates
Slide 8: GSK vaccines business
GSK vaccines business Over 30 approved vaccines and 20 in development Distributed 1.4 billion vaccine doses to 182 countries in 2009 Over 11,000 employees worldwide, including over 1650 scientists Global manufacturing network: 15 sites around the globe Succession plan for management of vaccines busi
Slide 9: GSK vaccines worldwide personnel
GSK vaccines worldwide personnel 12000 11195 9750 10000 9167 8000 8000 6262 6000 4478 4471 4144 4000 3332 2916 2578 2000 0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 9
Slide 10: Global manufacturing footprint
Global manufacturing footprint Ste-Foy (Quebec) & Laval Rixensart, Wavre, Gembloux Dresden Walvax, China GSK Biomed, Moscow Neptunus, China Gödöllö St-Amand-les-Eaux Shanghai Marietta Nashik Kaketsuken, Japan Hamilton Columbia Bangalore Taiwan Philadelphia Singapore Fiocruz, Brazil Industrial Operat
Slide 11: Adjuvants: advantages of adjuvant systems
Adjuvants: advantages of adjuvant systems Adjuvant Systems Immune response Stronger / Broader Longer-term immune response immune response Traditional formulation Early immune Time response Pulendran B & Ahmed R. Cell 2006;124:849–863 11
Slide 12: Adjuvants: why do we need better adjuvants?
Adjuvants: why do we need better adjuvants? To induce strong immune responses – Malaria, RTS,S (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
Slide 13: GSK vaccines: broad geographic opportunity
GSK vaccines: broad geographic opportunity GSK vaccines 2009 sales £3.7bn (+30%) US £815m (+9%) EU £1,744m (+37%) ROW £1,147m (+37%) Growth rate is CER 13
Slide 14: Geographical opportunity
Geographical opportunity US Emerging Markets Japan Arepanrix Arepanrix 14
Slide 15: GSK has the broadest vaccine portfolio in EM
GSK has the broadest vaccine portfolio in EM GSK Merck Sanofi Pfizer Novartis DTPw combos 9 9 9 DTPa combos 9 9 MMR / Varicella 9 9 9 Hepatitis A 9 9 9 Rotavirus 9 9 Meningococcal 9 9 d Pneumococcal 9 9 Influenza 9 9 9 HPV 9 9 Malaria d Dengue d d 9 = available in EM; d = in development 15
Slide 16: Emerging markets opportunity: China
Emerging markets opportunity: China China Licensed vaccines • Infanrix, Infanrix-Hib, Boostrix, Fluarix, Engerix-B, Hiberix, Havrix, Twinrix, Priorix, Varilrix £116m +36% Vaccines in development (2009) • Cervarix: phase III trials ongoing in China • Infanrix-IPV/Hib: IND Joint venture with Neptunus
Slide 17: Emerging markets opportunity: Brazil
Emerging markets opportunity: Brazil Brazil Over 25 year collaboration with Brazilian Ministry of Health (Fiocruz) £117m +10% (2009) Long term governmental contracts Technology transfer agreements • Oral polio vaccine (1980’s) • Hiberix (1998) • Priorix (2003) • Rotarix (2008) • Included in National
Slide 18: Opportunity in Japan
Opportunity in Japan Japanese vaccine market underdeveloped: £500m in 2009 Cervarix first HPV vaccine approved in Japan Rotarix first rotavirus vaccine filed in Japan GSK key supplier of H1N1 pandemic vaccine to Japanese government Partnership with Kaketsuken in flu and flu cell-culture Japan fully
Slide 19: GSK vaccines: a rich pipeline
GSK vaccines: a rich pipeline Phase I Phase II Phase III Submitted HIV Tuberculosis Mosquirix™ MenHibrix™ Malaria (HibMenCY-TT) New generation Cytomegalovirus Dengue seasonal flu NTHi-Pneumo WT1 MAGE-A3 ASCI Approved Acute myelogenous leukaemia1 Non-Small Cell Lung Cancer1 Heptavalent MAGE-A3 ASCI C
Slide 20: Late-stage assets: meningitis
Late-stage assets: meningitis Meningococcal disease causes permanent disability or death – Fatality rate 9-12% Five serogroups (A, B, C, W135, Y) cause the majority of invasive meningococcal disease GSK developing tailored meningitis vaccines to fulfil regional and age- related needs: – MenHibrix (H
Slide 21: Late-stage assets: influenza
Late-stage assets: influenza • Improved seasonal flu vaccines • Ongoing commitment to pandemic flu • Inclusion of additional B strain (quadrivalent) • Continuous innovation • Need for improved efficacy in both • Cell-culture paediatric and elderly populations • New delivery systems 21
Slide 22: GSK response to H1N1 pandemic
GSK response to H1N1 pandemic Integrated GSK response to pandemic – Pandemrix, Arepanrix, Relenza, Actiprotect Largest global supplier of H1N1 vaccine – Doses supplied to over 60 countries; approximately £1.9 billion sales £883 million (Q4 2009) £973 million (H1 2010) – 60 million dose donation to W
Slide 23: Late-stage assets: Herpes zoster vaccine
Late-stage assets: Herpes zoster vaccine • Herpes zoster (HZ) & Post-herpetic neuralgia (PHN) • After initial varicella zoster infection (chickenpox), VZV DNA remains latent Rate per in nerve cells 1.000 / year 12 • May reactivate later in life to cause HZ 1 (shingles) Zoster 1 PHN 10 • 1 in 4 will
Slide 24: Late-stage assets: malaria (RTS,S)
Late-stage assets: malaria (RTS,S) Significant burden of disease – Malaria kills almost 900,000 people every year1 Many in sub-Saharan Africa Majority are children under the age of five Phase III trials underway – 11 trial sites across 7 African countries – Current enrolment 8,923 children 3,246 inf
Slide 25: Evolution of a diversified business
Evolution of a diversified business Immuno- therapeutics for chronic disorders Immuno- Adolescent therapeutics & adult for vaccines cancer Paediatric vaccines 25
Slide 26: GSK key vaccines: 2009 sales
GSK key vaccines: 2009 sales Boostrix Synflorix £139m £73m Cervarix £187m Fluarix/FluLaval £211m Pandemic Flu £883m Rotarix £282m Infanrix/Pediarix Hepatitis £649m £665m 2009 sales: £3.7 billion (+30%) 26
Slide 27: Rotarix in 2010: returning to growth
Rotarix in 2010: returning to growth Approved in 116 countries Filed in Japan (November 2009) 2009 sales £282 million H1 2010 sales £104 million Rotarix global market share increased significantly in 2009 to 44% Geographic expansion into EM & Japan US currently accounts for 60% of global market WHO
Slide 28: Cervarix in 2010: future opportunities
Cervarix in 2010: future opportunities Approved in 111 countries Including US and Japan (October 2009) 2009 sales £187 million (+38%) H1 2010 sales £127 million (+4%) Over half of competitive tenders won Over two-thirds by volume WHO Prequalification (July 2009) Global access to Cervarix via UNICEF
Slide 29: Synflorix: successful launch
Synflorix: successful launch Approved in 71 countries Filed in additional 31 countries Significant tender wins and market share gains H1 2010 sales £83 million Long-term contract signed with Brazilian government €1.5 billion over 10 years Advance Market Commitment (AMC) for pneumococcal vaccines lau
Slide 30: Antigen-Specific Cancer Immunotherapeutics (ASCI): an overview
Antigen-Specific Cancer Immunotherapeutics (ASCI): an overview ASCI represent a novel class of compounds based on tumour antigens MAGE-A3 in Non-Small Cell Lung Cancer (NSCLC) – Positive phase II data 25 % reduction in the relative cancer recurrence following surgery at 44 months Well-tolerated with
Slide 31: Therapeutic vaccines
Therapeutic vaccines ASCI Nicotine Addiction Alzheimer’s MAGE-A3 in Phase III Nicotine conjugate vaccine Two candidate vaccines • NSCLC and melanoma (NicVAX)1 in development2 WT1 in Phase II Aid to smoking cessation and Targets beta-amyloid • AML long-term abstinence • Pivotal role in plaque Novel m
Slide 32: GSK vaccines in 2010
GSK vaccines in 2010 A world leader in vaccines One of the broadest portfolios and fastest growing vaccines businesses in the world Unique expertise in adjuvant technology Strong pipeline including innovative therapeutic vaccine approaches Global footprint: ideally positioned to capture a significan
Slide 33: GlaxoSmithKline
GlaxoSmithKline