A Focused Biopharmaceutical Company
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A focused biopharmaceutical company General presentation for investors and analysts December 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 is the global R&D headquarter Scientific collaborations are key drivers behind the move 4 Focused strategy Three therapy areas Cardiovascular, Renal & Respiratory Oncology Metabolism (and immunology) 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, Respiratory Oncology Renal & Metabolism (and immunology) Tagrisso1 roxadustat2 Fasenra1 NSCLC anaemia of CKD multiple indications Imfinzi1, 2 Breztri1, 2 multiple cancers COPD Lynparza1, 2 PT027 multiple cancers asthma trastuzumab deruxtecan2 tezepelumab breast and other cancers severe asthma capivasertib nirsevimab breast cancer lower respiratory tract infection Calquence1, 2 anifrolumab blood cancers lupus tremelimumab multiple cancers selumetinib NF1 savolitinib NSCLC 1. Lifecycle development programme. 2. Under regulatory review in major jurisdiction. Status as of 24 October 2019. 8 Full pipeline of new medicines (NMEs), 1 Phase I Phase II Phase III 20 New Molecular Entities 25 New Molecular Entities 14 New Molecular Entities AZD1390 Imfinzi#+tremelimumab adavosertib# Imfinzi#+tremelimumab capivasertib+chemotherapy CAPItello-290 Imfinzi#+tremelimumab+SoC NILE glioblastoma PD-L1+CTLA-4 solid tumours Wee1 ovarian cancer, solid tumours PD-L1+CTLA-4 gastric cancer AKT+chemotherapy mTNBC 1L PD-L1+CTLA-4+SoC 1L urothelial cancer AZD2811 Imfinzi#+/-tremelimumab+chemo AZD4573 Imfinzi#+tremelimumab+chemo Imfinzi#+tremelimumab Lynparza#+Imfinzi#+bevacizumab Aurora solid tumours, haematological POSEIDON CDK9 haematological malignancies PD-L1+CTLA-4 1L PDAC PD-L1+CTLA-4 biliary tract oesophageal DUO-O oesophageal SCLC malignancies PD-L1+/-CTLA-4+SoC 1L NSCLC PARP+PD-L1+VEGF 1L ovarian AZD5153 AZD4635 Imfinzi+Lynparza# BAYOU Imfinzi#+/-tremelimumab+CRT ADRIATIC BRD4 solid tumours, haematological Imfinzi+selumetinib# selumetinib#¶ SPRINT A2aR inhibitor solid tumours PD-L1+PARP bladder PD-L1+/-CTLA-4+CRT LS-SCLC malignancies PD-L1+MEK solid tumours MEK paediatric neurofibromatosis type-1 AZD5991 MEDI1191 capivasertib# Lynparza#+adavosertib# Imfinzi#+/-tremelimumab+SoC CASPIAN trastuzumab deruxtecan# MCL1 haematological malignancies IL-12 mRNA solid tumours AKT breast PARP+Wee1 solid tumours PD-L1+/-CTLA-4+SoC 1L ES-SCLC DESTINY-Breast 02 ADC breast AZD9496 MEDI2228 capivasertib# Lynparza#+AZD6738 VIOLETTE Imfinzi#+tremelimumab