A Focused Biopharmaceutical Company
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A focused biopharmaceutical company General presentation for investors and analysts August 2019 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 document contains certain forward-looking statements with respect to the operations, performance and financial condition of the Group, including, among other things, statements about expected revenues, margins, earnings per share or other financial or other measures. 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 document 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, or limitations to, patents, marketing exclusivity or trademarks, or the risk of failure to obtain and enforce patent protection; effects of patent litigation in respect of IP rights; the impact of any delays 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 of outsourcing; the risks associated with manufacturing biologics; the risk that R&D will not yield new products that achieve commercial success; the risk of delay to new product launches; the risk that new products do not perform as we expect; the risk that strategic alliances and acquisitions, including licensing and collaborations, will be unsuccessful; the risks from pressures resulting from generic competition; the impact of competition, price controls and price reductions; the risks associated with developing our business in emerging markets; the risk of illegal trade in our products; the difficulties of obtaining and maintaining regulatory approvals for products; the risk that regulatory approval processes for biosimilars could have an adverse effect on future commercial prospects; the risk of failure to successfully implement planned cost reduction measures through productivity initiatives and restructuring programmes; the risk of failure of critical processes affecting business continuity; economic, regulatory and political pressures to limit or reduce the cost of our products; failure to achieve strategic priorities or to meet targets or expectations; the risk of substantial adverse litigation/government investigation claims and insufficient insurance coverage; the risk of substantial product liability claims; the risk of failure to adhere to applicable laws, rules and regulations; the risk of failure to adhere to applicable laws, rules and regulations relating to anti-competitive behaviour; the impact of increasing implementation and enforcement of more stringent anti- bribery and anti-corruption legislation; taxation risks; exchange rate fluctuations; the risk of an adverse impact of a sustained economic downturn; political and socio-economic conditions; the risk of environmental liabilities; the risk of occupational health and safety liabilities; the risk associated with pensions liabilities; the impact of failing to attract and retain key personnel and to successfully engage with our employees; the risk of misuse of social medial platforms and new technology; and the risk of failure of information technology and cybercrime. Nothing in this presentation / webcast should be construed as a profit forecast. 2 Strategic priorities The new Deliver growth and therapy area strategic leadership priorities Accelerate innovative science Be a great place to work 3 Cambridge, UK now the global R&D headquarter Scientific collaborations are key drivers behind the move 4 Focused strategy Three therapy areas Cardiovascular, Renal & Oncology Respiratory Metabolism Commitment to further focus the portfolio 5 R&D productivity 2014-2018 Progress to sustain sales growth ~10x increase in the number of high-impact1 papers published 33% 30 increase in the number projects with validated of Phase II projects proof of mechanism 50+ 23 regulatory designations regulatory approvals in major markets2 in 20183 1. High-impact journal designated as 15 or more impact factor points, between 2014 and 2018. 2. US, EU, Japan and China. 3. Includes new medicines (NME) and new uses of existing medicines (LCM). Source: internal analysis based on public and internal data sources. 6 Late-stage pipeline news flow Significant news flow supports sustainable growth Lynparza Fasenra Lynparza Imfinzi Lynparza Imfinzi Lynparza Tagrisso Lumoxiti Lynparza breast cancer severe asthma ovarian cancer 2L unr. SIII NSCLC breast cancer unr. SIII NSCLC ovarian cancer 2L EGFRm NSCLC HCL 3L ovarian cancer 1L approval (US) approval (EU) approval (EU) approval (US) approval (JP) approval (JP) approval (CN) approval (JP) approval (US) approval (US) Lynparza Fasenra Tagrisso Lokelma Tagrisso Lokelma Bevespi Imfinzi Bydureon BCise Bevespi roxadustat ovarian cancer 2L severe asthma EGFRm NSCLC hyperkalaemia EGFRm NSCLC hyperkalaemia COPD unr. SIII NSCLC type-2 diabetes COPD anaemia-dialysis approval (JP) approval (JP) approval (US) approval (EU) approval (EU) approval (US) pos. opinion (EU) approval (EU) approval (EU) approval (EU) approval (CN) Approvals 2018: year of significant news flow to sustain return to growth Data, designations, regulatory submissions and/or acceptances PT010 Forxiga Forxiga selumetinib Symbicort Duaklir Lynparza Fasenra Farxiga Imfinzi COPD type-1 diabetes type-1 diabetes NF1 mild asthma COPD ovarian cancer 1L EGPA2 type-1 diabetes unr. SIII NSCLC Phase III pos. regulatory regulatory orphan designation regulatory regulatory reg. submission (EU, orphan designation reg. submission (US) regulatory submission (JP) submission (EU) (EU) submission (EU) submission (US) JP, CN) (US) submission (CN) Imfinzi + treme lanabecestat Fasenra Lynparza selumetinib Farxiga anifrolumab Imfinzi +/- treme Lynparza roxadustat NSCLC 3L Alzheimer’s disease COPD ovarian cancer 1L thyroid cancer CVOT1 lupus NSCLCL 1L ovarian cancer 3L anaemia of CKD Phase III neg. Phase III neg. Phase III neg. Phase III pos. Phase III neg. Phase III pos. Phase III neg. Phase III neg. Phase III pos. Phase III pos. selumetinib Imfinzi Lynparza Lynparza tezepelumab Tagrisso Bevespi PT010 Imfinzi +/- treme NF1 unr. SIII NSCLC (OS) breast cancer pancreatic cancer severe asthma EGFRm NSCLC COPD COPD head & neck cancer orphan designation Phase III pos. regulatory orphan designation breakthrough regulatory reg. submission (JP, reg. submission (JP, 2L (US) submission (EU) (US) designation (US) submission (CN) CN) CN) Phase III neg. Favourable news Unfavourable news 1. Cardiovascular outcomes trial 2. Eosinophilic granulomatosis with polyangiitis. Status as of 13 February 2019. 7 Late-stage pipeline and key lifecycle medicines Significant opportunities exist in all three therapy areas Cardiovascular, Oncology Respiratory Renal & Metabolism Tagrisso1, 2 roxadustat2 Breztri NSCLC anaemia of CKD COPD Imfinzi1, 2 PT027 multiple cancers asthma Lynparza1, 2 tezepelumab multiple cancers severe asthma trastuzumab deruxtecan breast and other cancers capivasertib breast cancer Calquence1 blood cancers Other medicines tremelimumab anifrolumab multiple cancers lupus selumetinib NF1 savolitinib NSCLC 1. Lifecycle development programme. 2. Under regulatory review in major jurisdiction. Status as of 25 July 2019. 8 Full pipeline of new medicines (NMEs), 1 Phase I Phase II Phase III 21 New Molecular Entities 22 New Molecular Entities 17 New Molecular Entities Imfinzi#+tremelimumab+chemo capivasertib+chemotherapy trastuzumab deruxtecan# AZD1390 adavosertib# Imfinzi#+tremelimumab PD-L1+CTLA-4 1L PDAC oesophageal CAPItello-290 DESTINY-Breast 02 glioblastoma Wee1 ovarian cancer, solid tumours PD-L1+CTLA-4 biliary tract oesophageal SCLC AKT+chemotherapy mTNBC 1L ADC breast trastuzumab deruxtecan# AZD4573 Imfinzi+selumetinib# AZD2811# Imfinzi+Lynparza# BAYOU Imfinzi#+tremelimumab DANUBE DESTINY-Breast 03 CDK9 haematalogical malignancies PL-L1+MEK solid tumours Aurora solid tumours PD-L1+PARP bladder PD-L1+CTLA-4 1L bladder ADC breast trastuzumab deruxtecan# AZD5153 MEDI1191 AZD4635 Lynparza#+adavosertib# Imfinzi#+tremelimumab HIMALAYA DESTINY-Breast 04 BRD4 solid tumours IL-12 mRNA solid tumours A2aR inhibitor solid tumours PARP+Wee1 solid tumours PD-L1+CTLA-4 1L HCC ADC breast Lynparza#+AZD6738 or +adavosertib# trastuzumab deruxtecan¶# AZD5991 MEDI2228 capivasertib# Imfinzi#+tremelimumab KESTREL VIOLETTE DESTINY-Breast01 MCL1 haematalogical malignancies BCMA ADC multiple myeloma AKT breast prostate PD-L1+CTLA-4 1L HNSCC PARP+ATR or PARP+Wee1 breast ADC breast Imfinzi#+(oleclumab or monalizumab# or trastuzumab deruxtecan¶# AZD9496 MEDI5083 Lynparza#+Imfinzi MEDIOLA Imfinzi#+tremelimumab NEPTUNE danvatirsen#) NeoCOAST DESTINY-Gastric01 SERD ER+ breast CD40 ligand fusion protein solid tumours PARP+PD-L1 ovarian breast gastric SCLC PD-L1+CTLA-4