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RIA TA Strategy 2013 MedImmune R&D Roadshow November 7, 2013 Gaithersburg, Maryland Cautionary Statement Regarding Forward-Looking Statements In order, among other things, to utilise the 'safe harbour' provisions of the US Private Securities Litigation Reform Act 1995, we are providing the following cautionary statement: This presentation contains certain forward-looking statements with respect to the operations, performance and financial condition of the Group. Although we believe our expectations are based on reasonable assumptions, any forward-looking statements, by their very nature, involve risks and uncertainties and may be influenced by factors that could cause actual outcomes and results to be materially different from those predicted. The forward-looking statements reflect knowledge and information available at the date of preparation of this presentation and AstraZeneca undertakes no obligation to update these forward-looking statements. We identify the forward- looking statements by using the words 'anticipates', 'believes', 'expects', 'intends' and similar expressions in such statements. Important factors that could cause actual results to differ materially from those contained in forward-looking statements, certain of which are beyond our control, include, among other things: the loss or expiration of patents, marketing exclusivity or trade marks, or the risk of failure to obtain patent protection; the risk of substantial adverse litigation/government investigation claims and insufficient insurance coverage; exchange rate fluctuations; the risk that R&D will not yield new products that achieve commercial success; the risk that strategic alliances and acquisitions will be unsuccessful; the impact of competition, price controls and price reductions; taxation risks; the risk of substantial product liability claims; the impact of any delay in the manufacturing, distribution and sale of any of our products; the impact of any failure by third parties to supply materials or services; the risk of failure to manage a crisis; the risk of delay to new product launches; the difficulties of obtaining and maintaining regulatory approvals for products; the risk of failure to observe ongoing regulatory oversight; the risk that new products do not perform as we expect; the risk of environmental liabilities; the risks associated with conducting business in emerging markets; the risk of reputational damage; the risk of product counterfeiting; the risk of failure to successfully implement planned cost reduction measures through productivity initiatives and restructuring programmes; the risk that regulatory approval processes for biosimilars could have an adverse effect on future commercial prospects; the impact of failing to attract and retain key personnel and to successfully engage with our employees and the impact of increasing implementation and enforcement of more stringent anti-bribery and anti-corruption legislation. Nothing in this presentation should be construed as a profit forecast. 2 Agenda Presentations: Dr. Bahija Jallal, Executive Vice President, AstraZeneca Head of MedImmune Dr. Bing Yao, Head of Respiratory, Inflammation & Autoimmune iMed Dr. Ed Bradley, Head of MedImmune Oncology iMed Q&A Reception 3 MedImmune, the global biologics R&D arm of AstraZeneca Dr. Bahija Jallal Executive Vice President, AstraZeneca Head of MedImmune Today’s Discussion Enterprise Strategy MedImmune’s Roadmap 5 Our Strategic Priorities 1 2 3 Achieve Return Be a great scientific to growth place to work leadership 6 Achieve Scientific Leadership 1 FOCUS on distinctive science in 3 core TAs Achieve PRIORITISE & ACCELERATE our pipeline scientific leadership TRANSFORM our innovation culture & model 7 FOCUS on distinctive science Our core focus in 3 core TAs Cardio- Respiratory/ Metabolism Oncology inflammation Infection & Vaccines Neuroscience Core TAs Opportunity-Driven Small Protein Biologics Molecules Immuno-therapies engineering 8 PRIORITISE & ACCELERATE Growing late-stage pipeline our pipeline Phase 1 - 25 NMEs Phase 2 - 23 NMEs Phase 3 / Reg - 8 NMEs Small molecule Biologics Small molecule Biologics Small molecule Biologics AZD5363* MEDI0639* selumetinib* MEDI-551* lesinurad moxetumomab* AKT solid tumours DLL-4 solid tumours MEK solid tumours CD19 CLL, DLBCL URAT1 gout CD22, HCL AZD2014 MEDI-565* AZD4547 tremelimumab PT003 brodalumab* TORK solid tumours CEA BiTE GI tumours FGFR solid tumours CTLA-4 solid tumours LABA/LAMA COPD IL-17R psoriasis volitinib* MEDI6469* olaparib MEDI-573* Epanova* metreleptin* MET solid tumours mOx40 solid tumours PARP-BRCA solid tumours IGF MBC hypertriglyceridaemia lipodystrophy AZD1208 MEDI4736* AZD5423* benralizumab* naloxegol* PIM haems PD-L1 solid tumours iSGRM COPD IL-5R asthma / COPD opioid induced constipation AZD8186 MEDI3617* AZD5069 mavrilimumab* CAZ AVI* PI3 solid tumours ANG-2 solid tumours CXCR2 asthma GM-CSFR RA BLI/cephalosporin SBI AZD9150* MEDI9929* AZD2115* MEDI8968* STAT3 haems TSLP asthma MABA COPD IL-1R COPD, HS AZD9291 MEDI5872* AZD1722* sifalimumab* EGFRm+ solid tumours B7RP1 SLE NHE3 ESRD/CKD IFNa SLE AZD8848* MEDI-551* AZD6765 MEDI-546* TLR7 asthma CD19 MS NMDA MDD IFNaR SLE Major Mkt Reg - 5 NMEs AZD7594* MEDI6012 AZD5213 tralokinumab Small molecule Biologics SGRM COPD LCAT, ACS H3R neuropathic pain IL-13 asthma, IPF, UC Caprelsa Q-LAIV Flu MEDI4893 AZD7624 AZD3241 MEDI7183* EGFR inhibitor MTC Intranasal influenza virus ip38i COPD staph alpha toxin SSI MPO Parkinson’s Disease α4β7 UC, Crohn’s Brilinta RDEA3170 MEDI-559 AZD5847 MEDI2070* ADP receptor antagonist URAT1 gout PRVV oxazolidinone TB IL-23 Crohn’s Forxiga* AZD3293* MEDI-550 CXL* SGLT2 inhibitor BSECDR Alzheimer’s Panflu library BLI/cephalosporin MRSA * Partnered Product Zinforo* ATM AVI skin infections BL/BLI SBI MedImmune comprises ~50% of the AZ pipeline Oncology RIA CVMD Neuroscience Infection Progressed New BD As of 30 June 2013 9 TRANSFORM our innovation Bringing It Together culture & model “Biotech Organizations” “Large Pharma” Research To POC Late Stage Development Innovative Medicines Small Molecules Global Medicines Development Combination Projects Scientific Collaboration Small Molecules & Biologics MedImmune Biologics 10 TRANSFORM our innovation Co-locate around three culture & model strategic sites Gaithersburg Cambridge Mölndal Co-locate around Co-locate R&D in world-class Leverage historical strength biologics/specialty care science cluster Respiratory and CV/Met Proximity to NIH, New site in Cambridge with close proximity to Connections to Karolinska Johns Hopkins, University of Cambridge and world class UK Institute & Medicon Valley FDA bioscience community 11 Today’s Discussion Enterprise Strategy MedImmune’s Roadmap 12 Building on a deep heritage of innovation During the past 25 years, MedImmune has played a role in the following… RSV Inflammatory Diseases HPV Vaccine RespiGam 1996 2002 2009 CMV Flu Vaccine SLE 1998 2003 2011 RSV HPV Vaccine Flu Vaccine 1998 2006 2012 13 Distinctive MedImmune strength in immunology is a foundation across TAs CVMD RIA Oncology ID / Vaccines NS Type 2 Respiratory & Immune Adjuvants & Neuro- Diabetes Autoimmune Mediated Chronic Inflammatory Disease Cancer Tx Infection Tx Deep understanding of immunology biology 14 MedImmune Antibody Technologies Competitive antibody design and protein engineering toolkit lets us tackle multiple targets Bispecific Ab-drug Single-chain immunotoxin Ab NK conjugate T cell mAb Ab (+YTE) mimetic BiTE Antibody* Internalized Ab Agonist/ ADCC antagonist mAb Blocks Induction Release of protein of T Cell cytotoxic drug synthesis Killing Target cell 15 Personalized healthcare and diagnostics 80% of our pipeline has a personalized healthcare approach Meaningful questions being asked by our Personalized Healthcare colleagues: • What is the right indication to pursue in the clinic? • What are the patient populations most likely to respond? • What is the PD biomarker needed to follow target engagement? • What are the biomarkers for proof of mechanism? • What are biomarkers of efficacy? • Do we need a companion diagnostic? 16 Characteristics of biologics seem to lead to greater likelihood of success NME Success By Molecule Size 2007–2011 Industry Portrait Preclinical Phase 1 Phase 2 Phase 3 Registration NME Entries To Achieve 1 Approval 2.0 1.9 1.2 1.2 Small Small 4.3 Large 7.6 9.9 Large 10.3 24.7 Success Rate For 61% 42% 20% 59% 84% Each Phase 77% 57% 44% 63% 83% 40.5 Percent Calculated 2% 4% 10% 50% 84% To Achieve 1 Approval 10% 13% 23% 52% 83% © KMR Group, Inc. 17 Biologics Pipeline Pre-Clinical Submission/ Discovery Phase 1 Phase 2 Phase 3 Development Approved Oncology Oncology Anti-DLL-4 MAb Moxetumomab Anti-IGF Mab Anti-CD19 MAb Moxetumomab Q-LAIV Flu Solid Tumor Pasudotox MBC CLL Pasudotox Vaccine Leukemia/Lympho Hairy Cell Leukemia Influenza Oncology Anti-CEA BITE® ma Anti-CD19 Mab Tremelimumab Brodalumab Solid Tumor DLBCL Solid Tumors Murine Anti-OX40 Psoriasis MAb RIA Anti-ANG2 MAb Solid Tumor Benralizumab Benralizumab Solid Tumor Anti-PD-L1 MAb Asthma COPD Solid Tumor RIA RIA Anti-CD19 MAb Sifalimumab Anti-IFNaR MAb MS SLE SLE Anti-TSLP MAb Oncology Asthma Infectious Anti-B7RP1 MAb Anti-IL-1R MAb Anti-IL-1R Mab Diseases/Vaccines Lupus COPD Hidradenitis Anti-Alpha Toxin Suppurativa Respiratory, Inflammation MAb and Autoimmunity (RIA) Infectious Pediatric RSV Mavrilimumab Brodalumab Staph Alpha Toxin Diseases/Vaccines Vaccine Rheumatoid Arthritis Asthma Pandemic Flu Infectious RSV Vaccine Disease/Vaccines Infectious CV/MD rhLCAT Influenza Brodalumab Anti-A4b7 MAb
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