Astrazeneca Plc · LSE:AZN
Astrazeneca — Investor Day (June 2012)
37 slides from Astrazeneca's investor day presentation, Jun 14, 2012
Slide 1: R&D Roundtable
R&D Roundtable Martin Mackay, President, R&D June 14th, 2012 1
Slide 2: Our vision for R&D
Our vision for R&D • Approval of valued medicines Perfor- mance • Positive return on investment Res ED LD • Consistent productivity Portfolio • High quality late-stage pipeline • Strong leadership cadre People • Smaller workforce Operating • Simpler footprint Model • Innovative operating models US E
Slide 3: Transforming R&D 2010-12
Transforming R&D 2010-12 Investing in the future of R&D People Capabilities Portfolio 31 of the top 50 >$200M over >40% of pipeline (60%) are new hires 5 years sourced externally • Personalised Healthcare • Predictive Science • Payer Evidence Mene Briggs Pangalos Morrison • Clinical Trial Innovative
Slide 4: Transforming R&D 2010-12: Managing the cost of R&D
Transforming R&D 2010-12 Managing the cost of R&D People Property Portfolio 23% reduction 21 Î12 facilities 18% reduction 4
Slide 5: Building a high quality pipeline
Building a high quality pipeline 5 Rs Assurance Mapping Real-World Evidence 5
Slide 6: Potential 2012-13 phase III investment decisions
Potential 2012-13 phase III investment decisions Assets Area under investigation AZD6244 – selumetinib (MEK Inhibitor) NSCLC / Melanoma MEDI-1123 – tremelimumab (anti-CTLA-4 MAb) Solid tumours AZD8931 (erbB kinase inhibitor) Breast cancer CXL (beta lactamase inhibitor/cephalosporin) MRSA CAZ AVI (be
Slide 7: Late stage pipeline progress
Late stage pipeline progress Phase III Submitted New indications Launched/Approved Naloxegol Renal impairment Further markets USA, Europe Europe USA, Canada, Brazil CAZ AVI Add-on to insulin Russia Europe China USA Fostamatinib 1st Line Further markets Japan Japan Europe, Canada, Brazil COPD Add-on
Slide 8: Our priorities for R&D
Our priorities for R&D 1 Deliver the late-stage portfolio Secure high value late-stage 2 partnerships Achieve 8-11 positive POCs in 3 2012-14 Maximise LCM and emerging 4 markets All at the right cost and demonstrating progressive return on invested capital 8
Slide 9: R&D Roundtable: Mene Pangalos, Innovative Medicines
R&D Roundtable Mene Pangalos, Executive VP, Innovative Medicines June 14th, 2012
Slide 10: The people behind our science
The people behind our science Susan Galbraith Manos Perros Maarten Kraan Oncology iMed Infection iMed R&I iMed Track record of delivery Led Novartis Institute Experienced rheumatologist in cancer biology and for Tropical Disease and clinician drug development Former VP and Head Formerly of Roche, Jo
Slide 11: Accountability at every stage
Accountability at every stage Martin Mackay President R&D Innovative Medicines (IM) Global Medicines Development Target Selection Æ Proof of Concept Late-stage development IM Research Board Product Internal and external Review Market opportunities Board Product Development Committee Portfolio Invest
Slide 12: Driving quality, not quantity
Driving quality, not quantity Right target Benefits • Increasing our focus on key projects and Right tissue/ Impact competitive position Right exposure • 30% decrease in IM • Increasing the odds of portfolio volume pipeline to deliver Right safety • 83% of projects • Removing low value stopped in pr
Slide 13: Small molecule led NME's
Small molecule led NME’s Phase 1 Phase 2 Phase 3/registration AZD5363 AZD6244 (Selumetinib) Caprelsa™ Legend (AKT) Solid tumors (MEK ) Solid tumors (VEGFR/EGFR) MTC AZD3514 Fostamatinib TC-5214 Fostamatinib (SYK) Haematological malignancies MDD (adjunct) Oncology (AR down regulator) Prostate cancer
Slide 14: 'Hot' science
‘Hot’ science ... CXCR2 (AZD5069) – Phase IIa NMDAr (AZD6765) – Phase IIb Severe Asthma Major depressive disorder (MDD) OPPORTUNITY OPPORTUNITY • Asthma is one of the most prevalent chronic • Globally 450 million people suffer a mental or conditions, affecting over 300 million worldwide. behavioral
Slide 15: Partnering for success
Partnering for success Achievements to date 15
Slide 16: Progress with the virtual iMed
Progress with the virtual iMed Achievements to date Optimised Improved Partnering with resources productivity the best • Small headcount • Leadership in place • Proprietary discovery across network of partners • Simplified footprint • Autonomous drug ‘hunters’ • Flexible collaborations • Based in ma
Slide 17: R&D Roundtable: Bahija Jallal, MedImmune
R&D Roundtable Bahija Jallal, Executive VP R&D, MedImmune June 14th, 2012
Slide 18: A pipeline poised to advance into phase III
A pipeline poised to advance into phase III Phase 1 Phase 2a Phase 2b Ph3/Reg/Launch moxetumomab MEDI-575 tremelimumab MEDI-3250 Legend (CD22) pALL, DLBCL, HCL (PDGFrα) GBM, NSCLC (CTLA-4) Solid Tumors Q/LAIV Flu Vaccine MEDI-0639 MEDI-551 benralizumab Oncology (DLL-4) Solid Tumors (CD19) CLL, DLBCL
Slide 19: New approaches to building the R&D pipeline
New approaches to building the R&D pipeline Asset Indications Phase Brodalumab Psoriasis & 2b INNOVATIVE AMGEN PARTNERSHIP (AMG 827) Psoriatic Arthritis • MedImmune and Amgen are jointly Asthma 2a developing and commercializing five AMG 139 Crohn’s 1 monoclonal antibodies from Amgen’s AMG 157 Asthma
Slide 20: Benralizumab (MEDI-563): Asthma (Phase 2b)
Benralizumab (MEDI-563): Asthma (Phase 2b) Anti IL-5 receptor mAb that depletes eosinophils and basophils UNMET MEDICAL NEED Effect on Blood Eosinophils in Asthma Patients • Eosinophilic asthma represents ~40-60% of all patients with asthma and is characterized by more frequent exacerbations and hig
Slide 21: Sifilimumab (MEDI-545): SLE (Phase 2b)
Sifilimumab (MEDI-545): SLE (Phase 2b) Anti IFNα mAb that prevents signaling through the Type I IFN receptor UNMET MEDICAL NEED Inhibition of type I IFN-inducible genes (Day 0–28) • There is a significant unmet need in SLE for therapies that can reduce long-term steroid use and its associated side e
Slide 22: Moxetumomab pasudotox (CAT-8015): ALL (Ph 1b)
Moxetumomab pasudotox (CAT-8015): ALL (Ph 1b) Anti CD22 immunotoxin that uniquely delivers toxins to malignant B-cells UNMET MEDICAL NEED Activity in Pediatric ALL • Anti-CD20 therapy with rituximab has improved outcomes for cancer patients. Pre Treatment However, many patients relapse and stand to
Slide 23: R&D Roundtable: Susan Galbraith, Oncology
R&D Roundtable Susan Galbraith, iMed Head, Oncology June 14th, 2012
Slide 24: Our oncology pipeline
Our oncology pipeline Phase I Phase II AZD2014 AZD4547 Breast TOR kinase inhibitor FGFR TKI AZD8931 erbB kinase inhibitor MEDI-573 AZD5363 Anti-IGF MAb AKT inhibitor AZD3514 AZD5363 Urology AR down-regulator AKT inhibitor Selumetinib AZD4547 AZD6244 FGFR TKI MEK inhibitor Lung AZD1480 JAK 1, 2 inhib
Slide 25: Lung Cancer – The first solid cancer diagnosed by genetic driver
Lung Cancer – The first solid cancer diagnosed by genetic driver and treated by genetically targeted agents Historical View 1987 2004 2012 Large-cell KRAS KRAS KRAS Adeno- Unknown carinoma EGFR EGFR Squamous Unknown Unknown • Worldwide, lung cancer is • 1987: Discovery showed • 2001-04: AstraZeneca
Slide 26: MEK inhibitor: AZD6244 (Selumetinib)
MEK inhibitor AZD6244 (Selumetinib) – Treatment for lung cancer OPPORTUNITY • KRAS mutation positive non-small cell lung cancer (NSCLC) represents ~20% of lung cancer and is a disease associated with a poor prognosis DIFFERENTIATION POTENTIAL • To drive and lead the establishment MAPK PI3K INSR FGFR
Slide 27: MEK inhibitor: AZD6244 (Selumetinib) lung cancer data
MEK inhibitor AZD6244 (Selumetinib) – Treatment for lung cancer WHY WE BELIEVE IN THIS APPROACH AZD6244 + Placebo + docetaxel docetaxel • Phase I achieved Proof of Mechanism and (N=43) (N=40) Principle at tolerated dose Response 16 (37%) 0 • Significant improvement in PFS with Non-response 27 (63%)
Slide 28: Fibroblast growth factor receptor (FGFR) inhibitor
Fibroblast growth factor receptor (FGFR) inhibitor AZD4547 – Treatment for gastric, lung and breast cancers OPPORTUNITY • Disregulation of FGF/ FGFR signalling is associated with early relapse and poor survival, particularly in patients with gastric tumours DIFFERENTIATION POTENTIAL Bladder mut ~70%
Slide 29: FGFR inhibitor AZD4547: why we believe in this approach
Fibroblast growth factor receptor (FGFR) inhibitor AZD4547 – Treatment for gastric, lung and breast cancers WHY WE BELIEVE IN THIS APPROACH Lung primary explants with FGFR1 gene amplification regress when treated with • Primary explant models from patients’ AZD4547 in vivo tumours with FGFR gene amp
Slide 30: R&D Roundtable: Bill Mezzanotte, GMed
R&D Roundtable Bill Mezzanotte, GMed Head, Respiratory, Inflammation and Neuroscience June 14th, 2012
Slide 31: Increasing our success in late stage development
Increasing our success in late stage development Decrease Reduce our cycle time our costs INCREASE THE SUCCESS RATE Increase the analytic rigor in our programmes 31
Slide 32: Phase III heat maps and probability of success
Phase III heat maps and probability of success Efficacy map Safety map 1. What is the magnitude of your PoC Clinical 1. What is the severity of your safety signal relative to your base TPP? signal(s) prior to PhIII? 2. How similar is your planned Phase III 2. What is the frequency of safety Clinical
Slide 33: Repeated Critical Evaluation Over Time Helps to Identify the Most Promising Molecules
Repeated Critical Evaluation Over Time Helps to Identify the Most Promising Molecules High uncertainty Pre-Clinical Low knowledge Select Target Critical Questions Select Lead Series Critical Questions Select Candidate Drug Critical Questions Proof of Mechanism Critical Questions Proof of Principle C
Slide 34: BRILINTA: Regulatory rigour for greater success
Regulatory rigour for greater success BRILINTA: First Regulatory Approval Achieved in Europe —December 2010 Achieved regulatory approvals in 38 countries across 5 continents within 6 months of first approval External preparedness Internal preparedness Environmental factors Competitive intelligence R
Slide 35: Increasing payer outcomes
Increasing payer outcomes Research Development Commercialisation We deliver clinical and economic evidence for payers to understand the value of our medicines in achieving better, cost effective healthcare Strategic & Payer Payer Payer Evidence Real World Operational Insights Analytics Strategy Evid
Slide 36: Impressive clinical trial capability
Impressive clinical trial capability BRILINTA PLATO Trial Real World Design & Head to Head Superiority Acute Coronary Syndrome • Trial design reflected ACS treatment decisions – 18,700 patients in 43 countries • Superiority achieved against current ACS standard of care • Payer and physician needs ad
Slide 37: Significant improvement in R&D productivity: Cost per patient
Significant improvement in R&D productivity: Example: Cost per patient AZ has reduced “cost per patient” by more than 30% in the period 2010-2012 -30% 2009 2010 2011 Source: R&D Clinical June 2012 37