A focused biopharmaceutical company. General presentation for investors and analysts 20 June 2018

Transcription

1 A focused biopharmaceutical company General presentation for investors and analysts 20 June 2018

2 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

3 Strategic priorities Achieve scientific leadership 1 Return to growth 2 Be a great place to work 3 3

4 New Cambridge, UK R&D centre and HQ Scientific collaborations key driver behind move 4

5 Focused strategy Three therapy areas Oncology Cardiovascular, Renal & Metabolism Respiratory Commitment to further focus the portfolio 5

6 R&D productivity: Sustainable progress A new AstraZeneca with science-based culture Scientific publications High-impact publications Medium-impact publications Other publications FDA BTDs granted in AZN s main therapy areas Sustainable level of potential new medicines in Phase II trials Oncology Respiratory CVRM Other 1, Source: Internal analysis. High-impact (rating > 15); medium-impact (rating > 5); other (rating < 5). AstraZeneca (AZN) and industry peers/competitors (CP) 1-7. Source: Internal analysis based on focr.org. Includes Breakthrough Therapy Designations (BTD) in the three main AstraZeneca therapy areas.

7 Late-stage pipeline news flow Unprecedented activity level in 17 Forxiga type-2 diabetes Approval (CN) Siliq psoriasis Approval (US, by partner) benralizumab severe, uncontrolled asthma Regulatory submission (JP) Imfinzi bladder cancer Approval (US) Kyntheum psoriasis Approval (EU, by partner) Lynparza ovarian cancer 2L, 4L/tablets Approval (US) Symbicort COPD exacerbations Approval (US) Imfinzi lung cancer (PACIFIC) Reg. submission (US, EU, JP) Tagrisso lung cancer (FLAURA) Reg. submission (EU, JP) Tagrisso lung cancer (AURA3) Full approval (US, EU) Qtern type-2 diabetes Approval (US) ZS-9 hyperkalaemia CHMP 1 opinion (EU) Faslodex breast cancer 1L Approval (EU, JP) Bevespi COPD 2 Reg. submission (EU) Farxiga + Bydureon type-2 diabetes Approval (US, EU) Calquence mantle cell lymphoma Approval (US) roxadustat anaemia Completed reg. submission (CN, by partner) Fasenra severe, uncontrolled asthma Approval (US) Tagrisso lung cancer Approval (CN) ZS-9 hyperkalaemia Complete Response (US) Lynparza ovarian cancer 2L Reg. submission (EU, JP) Lynparza breast cancer Reg. submission (US, JP) Faslodex breast cancer Approval (US) Bydureon BCise type-2 diabetes autoinjector Reg. submission (EU) Brilique prior myocardial infarction Approval (CN) Bydureon BCise type-2 diabetes autoinjector Approval (US) Fasenra severe, uncontrolled asthma CHMP opinion (EU) Regulatory actions Data & designations Significant patient benefits anticipated to support return to growth Lynparza breast cancer Phase III positive Farxiga type-2 diabetes CVD-REAL study Imfinzi lung cancer (PACIFIC) Phase III positive (PFS 3 ) Tagrisso lung cancer (FLAURA) Phase III positive tralokinumab severe, uncontrolled asthma Phase IIIs negative Farxiga type-1 diabetes Phase IIIs positive Duaklir COPD Phase III positive Tagrisso lung cancer (FLAURA) Breakthrough Therapy Designation (US) inebilizumab neuromyelitis optica spectrum disorder Orphan designation (EU) Lynparza ovarian cancer Orphan Drug designation (JP) Bydureon type-2 diabetes (CVOT) Phase III met primary safety objective; did not meet primary efficacy objective Imfinzi lung cancer (MYSTIC) Phase III negative (PFS) Calquence mantle cell lymphoma Breakthrough Therapy Designation (US) moxetumomab hairy cell leukaemia Phase IIIs positive tezepelumab severe, uncontrolled asthma Phase IIb positive Imfinzi lung cancer (PACIFIC) Breakthrough Therapy Designation (US) 7 1. The Committee for Medicinal Products for Human Use. 2. Chronic obstructive pulmonary disease. 1. Progression-free survival. Status as of 14 December Favourable / unfavourable news.

8 Late-stage pipeline and key lifecycle medicines Significant opportunities exist in all three therapy areas 8 Oncology Lynparza 1, 2 multiple cancers Tagrisso 1, 2 lung cancer Imfinzi 1, 2 multiple cancers Calquence 1 blood cancers moxetumomab pasudotox 2 leukaemia tremelimumab multiple cancers selumetinib thyroid cancer savolitinib kidney cancer 1. Lifecycle development programme. 2. Under regulatory review in major jurisdiction. Status as of 20 June Cardiovascular, Renal & Metabolism roxadustat 2 anaemia Other anifrolumab lupus Respiratory PT010 COPD / asthma tezepelumab severe, uncontrolled asthma

9 Full pipeline of new medicines (NMEs) Phase I Phase II Phase III 31 New Molecular Entities 21 New Molecular Entities 8 New Molecular Entities Small molecule Large molecule Small molecule Large molecule Small molecule Large molecule AZD0156 ATM solid tumours AZD4831 MPO HFpEF MEDI0562# hox40 solid tumours adavosertib# (AZD1775)+chemotherapy Wee1+chemo ovarian cancer MEDI0382 GLP-1/glucagon type-2 diabetes Lynparza +cediranib CONCERTO PARP+VEGF recurrent Pt-R ovarian Imfinzi#+tremelimumab MYSTIC PD-L1+CTLA-4 1L NSCLC AZD1390 ATM healthy volunteer study AZD9977 MCR cardiovascular MEDI1873 GITR solid tumours AZD4547 FGFR solid tumours MEDI5884# cholesterol modulation cardiovascular savolitinib# SAVOIR MET prcc tezepelumab# NAVIGATOR SOURCE TSLP severe uncontrolled asthma AZD2811# Aurora solid tumours AZD1402# inhaled IL-4Ra asthma MEDI3726# PSMA prostate capivasertib (AZD5363)# AKT breast cancer MEDI6012 LCAT cardiovascular selumetinib ASTRA MEK differentiated thyroid cancer anifrolumab# TULIP Type I IFN receptor SLE AZD4573 CDK9 hematalogical malignancies AZD5634 inhaled ENaC cystic fibrosis MEDI4276 HER2 solid tumours vistusertib mtor 1/2 solid tumours MEDI3902 Psl/PcrV Pseudomonas pneumonia PT010 LABA/LAMA/ICS COPD AZD4635 A2aR inhibitor solid tumours AZD7594+abediterol# Inhaled SGRM+LABA asthma/copd MEDI5083 CD40 ligand fusion protein solid tumours AZD5718 FLAP coronary artery disease MEDI8852 influenza A treatment lanabecestat# BACE early alzheimer's disease AZD4785 KRAS solid tumours AZD5153 BRD4 solid tumours AZD0284 RORg psoriasis/respiratory MEDI7247 antibody drug conjugate haems oleclumab CD73 solid tumours AZD8601# VEGF-A cardiovascular verinurad URAT-1 chronic kidney disease MEDI8897# passive RSV prophylaxis prezalumab# primary Sjögren s syndrome Applications Under Review 2 New Molecular Entities Small molecule Large molecule AZD5991 MCL1 hematalogical malignancies MEDI7219 anti-diabetic type-2 diabetes abediterol# LABA asthma/copd suvratoxumab α-toxin Staphylococcus pneumonia roxadustat# HIFPH anaemia CKD/ESRD moxetumomab pasudotox# PLAIT CD22 3L HCL AZD6738 ATR solid tumours MEDI3506 IL-33 COPD AZD1419# inhaled TLR9 asthma AZD8186 PI3Kβ solid tumours MEDI0700# BAFF/B7RP1 SLE AZD7594 Inhaled SGRM asthma/copd AZD9496 SERD ER+ breast MEDI1341 alpha synuclein parkinson's disease AZD7986# DPP1 COPD 1 Includes significant fixed-dose combination projects, and parallel indications that are in a separate therapy area. # Partnered and/or in collaboration; Registrational Phase II/III study. MEDI9197# TLR 7/8 solid tumours MEDI1814# amyloidβ alzheimer's disease AZD8871# MABA COPD Oncology Cardiovascular, Renal & Metabolism Respiratory Other 9 Status as of 18 May MEDI7352 NGF/TNF osteoarthritis pain AZD9567 SGRM RA/respiratory

10 Late-stage pipeline news flow 2018 & 2019 Unlocking and realising potential of new medicine Q H Regulatory decision Tagrisso - lung cancer (EU) Lokelma - hyperkalaemia (US) Lynparza - breast cancer (JP) Tagrisso - lung cancer (JP) Imfinzi - lung cancer (PACIFIC) (EU, JP) moxetumomab pasudotox - HCL 3L (US) Bydureon autoinjector - type-2 diabetes (EU) Bevespi - COPD (EU) Lynparza - breast cancer (EU) Regulatory submission Duaklir - COPD (US) Bevespi - COPD (JP) Lynparza - ovarian cancer 1L Imfinzi +/- treme - lung cancer (MYSTIC) - head & neck cancer 2L (EAGLE) selumetinib - thyroid cancer PT010 - COPD Fasenra - COPD Lynparza - pancreatic cancer Imfinzi + treme - lung cancer 1L (NEPTUNE) Imfinzi +/- treme - lung cancer (POSEIDON) - small-cell lung cancer (CASPIAN) - bladder cancer 1L (DANUBE) - head & neck cancer 1L (KESTREL) Calquence - chronic lymphocytic leukaemia Brilinta - CAD 2 /type-2 diabetes CVOT Farxiga - type-2 diabetes CVOT (DECLARE) roxadustat - anaemia (US) anifrolumab - lupus 10 Key Phase III data readouts 1. Cardiovascular outcomes trial. 2. Coronary artery disease. Status as of 18 May Lynparza - ovarian cancer 1L Fasenra - COPD (TERRANOVA) Imfinzi +/- treme - lung cancer (MYSTIC) (final OS) - head & neck cancer 2L (EAGLE) - head & neck cancer 1L (KESTREL) selumetinib - thyroid cancer Farxiga - type-2 diabetes CVOT 1 (DECLARE) roxadustat - anaemia anifrolumab - lupus Lynparza - pancreatic cancer Imfinzi - lung cancer (PACIFIC) (final OS) Imfinzi + treme - lung cancer 1L (NEPTUNE) Imfinzi +/- treme - lung cancer (POSEIDON) - small-cell lung cancer (CASPIAN) - bladder cancer 1L (DANUBE) Calquence - chronic lymphocytic leukaemia Brilinta - CAD/type-2 diabetes CVOT Farxiga - heart failure lanabecestat - Alzheimer s disease

11 2018: return to growth on track Momentum to improve during the year Q1 impacted by Crestor EU/JP; divestments Comparisons easing as the year progresses Medicines that are impacting Product Sales growth in 2018 Lynparza ongoing launch of tablet in ovarian and breast cancer Tagrisso ongoing launch in 1st-line lung cancer Imfinzi ongoing launch in unresect. siii lung cancer Product Sales growth BMS Diabetes Alliance Brilinta continued global growth Crestor annualisation of loss of exclusivity (EU, JP) Farxiga continued global growth and the DECLARE trial Fasenra ongoing launch in severe, uncontrolled asthma FY 2010 FY 2011 FY 2012 FY 2013 FY 2014 FY 2015 FY 2016 Q Q Q Q Q : low single-digit growth in Product Sales 11 Change (Product Sales growth) and 2018 guidance at CER.

12 Product Sales: Oncology, China were the key drivers Overall performance impacted by Crestor EU / JP, divestments Q $m % change % Product Sales Product Sales 4,985 (2) 100 Oncology 1, New CVRM Respiratory 1,181 (6) 24 Other 1,674 (19) 34 Emerging Markets 1, of which China 1, Product Sales values at actual exchange rates; change at CER.

13 Strategic value-creation framework R&D productivity & focus drive decisions Externalisation 1 (milestones/royalty) Accelerate/enhance value; or new medicines outside focus R&D productivity Following the science leads to innovation in and outside areas of focus Focus on three main therapy areas Oncology CVRM - Cardiovascular, Renal & Metabolism Respiratory Product Sales (Including Growth Platforms) Other Operating Income 2 Disposal, typically of legacy medicines outside focus Medicines in which AstraZeneca maintains a significant future interest. Income through (recurring) milestones and royalty. 2. One-off disposal income and legacy royalty income.

14 Emerging Markets Geographic platform for growth US 31% of Product Sales Europe 24% of Product Sales China 15% of Product Sales Japan 11% of Product Sales Product Sales as reported. Emerging Markets (ex-china) 16% of Product Sales Rest of World Established (ex-japan) 4% of Product Sales

15 Emerging Markets Primary care key to success 51% North America $ bn growth 32% 68% Europe $42-49bn growth 49% 9% 85% 15% Asia $70-90bn growth Latin America $20-25bn growth 94% 6% 91% AFME $15-20bn growth Specialty care Primary care 16 60% 40% World $ bn growth Share of absolute growth by region, specialty and primary care Source: IMS Market Prognosis, September 2016; QuintilesIMS Institute, October Chart notes: Growth in US$ using constant exchange rates. Asia: China, India, Russia, CIS states, SE Asia, Oceania and Japan. AFME: Africa and Middle East.

16 Core Profit & Loss Q $m % change % Total Revenue Total Revenue 5,178 (9) Product Sales 4,985 (2) 96 - Externalisation Revenue 193 (67) 4 Gross Margin 78.8% (4) pp - Operating Expenses 3,349 (1) 65 - R&D Expenses 1,240 (12) 24 - SG&A Expenses 2, Other Operating Inc. & Exp. 124 (64) 2 Tax Rate 18% - - EPS $0.48 (51) - Absolute values at actual exchange rates; change at CER. Gross Margin reflects Gross Profit derived from Product Sales, divided by Product Sales. 17

17 Sustainability As a company built on delivering positive health outcomes, sustainability underpins everything AstraZeneca does 19 As we strive to reach 200 million patients by 2025, we are evolving our approach and in 2017 rolled out a roadmap that further embedded sustainability into the Company s DNA This will ensure AstraZeneca effectively addresses the most fundamental issues for business, shareholders, society and the environment

18 Sustainability - recent highlights #2 Overall in Pharmaceuticals, Biotechnology and Life Sciences industry group #1 in sector: Health Outcomes Contribution, Marketing Practices, Climate Strategy Healthy Heart Africa Program: Over one million patients screened in 2015, exceeding its year-one target Increased the number of senior managers who are women to 42% Achieved a 21.2% cut in our greenhouse gas footprint from 2010 levels 100% of employees trained on Code of Conduct 20

19 Great place to work Discovery, development and commercial structure Discovery and early development Late-stage development Commercial Internal and external opportunities Innovative Medicines and Early Development Biotech Unit (AstraZeneca Research and Early Development) Collaborations and combinations MedImmune Biotech Unit (MedImmune Research and Early Development Global Medicines Development Global Portfolio & Product Strategy Market 21

20 Great place to work Gothenburg, Sweden Strategic R&D Centre Cambridge, UK Headquarters Gaithersburg, US Strategic R&D Centre 22

21 Great place to work Realising company vision 1. A passion for people development 2. Strong, supportive, leadership at all levels 6. Access to medicines & social responsibility Values and Purpose 3. Flawless technology and ways of working 5. Environmental sustainability 4. Energising sites and workplaces 23

22 Great place to work External recognitions 24

23 Encouraging launches underpin 2018 return to growth Financials on track - commercial execution - guidance reiterated Financials on track Product Sales as anticipated Strong execution of launches; offset by tail of Crestor EU/JP and divestments Total Revenue impacted by lower Initial Externalisation Revenue Core operating expenses declined by 1% Newer medicines delivered $0.4bn in additional sales vs. Q and 66% growth Lynparza, Tagrisso, Imfinzi all very strong CVRM blockbusters Brilinta and Farxiga continued growth Respiratory competitive, but Fasenra off to a rapid start China maintained fast growth Pipeline continued to deliver important news flow 2018 guidance reiterated 25 Absolute values, change and guidance all at CER.

24 On track: Long-term goals >$45bn in Building strong foundations Delivering on return to growth Sustainable delivery and growth 26 Target is at constant exchange rates (2013) which is equivalent to ~$40bn at current exchange rates.

25 Investor Relations Thomas Kudsk Larsen Cambridge, UK T: M: Nick Stone Cambridge, UK T: M: Craig Marks Cambridge, UK T: M: Christer Gruvris Cambridge, UK T: M: Henry Wheeler Cambridge, UK T: M: Jen Kretzmann Cambridge, UK T: +44 xx xxxx xxxx M: Mitchell Chan Washington D.C., US Toll free astrazeneca.com/investors 27 Use of AstraZeneca webcast, conference call and presentation slides The AstraZeneca webcast, conference call and presentation slides (together the AstraZeneca Materials ) are for your personal, non-commercial use only. You may not copy, reproduce, republish, post, broadcast, transmit, make available to the public, sell or otherwise reuse or commercialise the AstraZeneca Materials in any way. You may not edit, alter, adapt or add to the AstraZeneca Materials in any way, nor combine the AstraZeneca Materials with any other material. You may not download or use the AstraZeneca Materials for the purpose of promoting, advertising, endorsing or implying any connection between you (or any third party) and us, our agents or employees, or any contributors to the AstraZeneca Materials. You may not use the AstraZeneca Materials in any way that could bring our name or that of any Affiliate into disrepute or otherwise cause any loss or damage to us or any Affiliate. AstraZeneca PLC, 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, CB2 0AA. Telephone ,