Astrazeneca Plc · LSE:AZN
Astrazeneca — Investor Day (December 2017)
43 slides from Astrazeneca's investor day presentation, Dec 14, 2017
Slide 1: Investor science event: Late-stage pipeline webcast
Investor science event: Late-stage pipeline webcast Sean Bohen, EVP, Global Medicines Development, Chief Medical Officer 14 December 2017
Slide 2: Forward-looking statements
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, pe
Slide 3: Agenda & introduction
Agenda & introduction Presenter Participants for Q&A Rob Iannone Elisabeth Björk Sean Bohen Head of Immuno-Oncology, Head of Cardiovascular and Executive Vice President, Global Medicines Development Metabolic Diseases, Global Global Medicines Development Medicines Development and Chief Medical Offic
Slide 4: Agenda
Agenda Oncology Cardiovascular and Metabolic Diseases Pancreatic beta cells at different stages of regeneration: AstraZeneca is investing in research that could Respiratory stimulate the regeneration of beta cells in the pancreas with the aim of stopping the progression of, or reversing, the course
Slide 5: Updated epidemiology data
Updated epidemiology data • First release of comprehensive company- compiled epidemiology data since 2014 • Contains current, best AstraZeneca estimates of patient numbers in major indications and countries relevant for key approved medicines and new potential medicines in development • Spreadsheet
Slide 6: Late-stage pipeline news flow: Unprecedented activity level in '17
Late-stage pipeline news flow Unprecedented activity level in ‘17 Forxiga Siliq benralizumab Imfinzi Kyntheum Lynparza Symbicort Imfinzi Tagrisso type-2 diabetes psoriasis severe, uncontrolled asthma bladder cancer psoriasis ovarian cancer 2L, 4L/tablets COPD exacerbations lung cancer (PACIFIC) lung
Slide 7: R&D productivity: Sustainable progress
R&D productivity: Sustainable progress A new AstraZeneca with science-based culture Scientific publications FDA BTDs granted in AZN’s Sustainable level of potential High-impact publications main therapy areas 2016-2017 new medicines in Phase II trials Medium-impact publications Other publications On
Slide 8: Late-stage pipeline and key lifecycle medicines
Late-stage pipeline and key lifecycle medicines Significant opportunities exist in all three therapy areas Cardiovascular and Oncology Respiratory Metabolic Diseases Lynparza1, 2 ZS-92 Fasenra1 multiple cancers hyperkalaemia severe, uncontrolled asthma2 / COPD Tagrisso1, 2 roxadustat2 PT010 lung can
Slide 9: Agenda
Agenda Oncology Cardiovascular and Metabolic Diseases Pancreatic beta cells at different stages of regeneration: AstraZeneca is investing in research that could Respiratory stimulate the regeneration of beta cells in the pancreas with the aim of stopping the progression of, or reversing, the course
Slide 10: Oncology: Strategic priorities support the return to growth
Oncology Strategic priorities support the return to growth Multiple cancers Lung cancers Blood cancers • Ovarian and breast • 2nd line / T790Mm1 • Locally-advanced/Stage • First AstraZeneca cancers • 1st line / EGFRm2 III, unresectable NSCLC3 medicine in blood cancer • Lifecycle programme • Adjuvant
Slide 11: Lynparza: PARP inhibitor with Phase III data in ovarian and breast cancer
Lynparza The PARP inhibitor with Phase III data in ovarian and breast cancer Impressive patient benefit …and impressive patient Regulatory status in ovarian cancer… benefit in breast cancer Ovarian cancer SOLO-2 trial in 2nd-line BRCAm1 ovarian cancer OlympiAD trial in 1st to 3rd-line breast cancer
Slide 12: Lynparza: Expand through Merck collaboration
Lynparza Significant opportunity to further expand through Merck collaboration Extensive lifecycle programme underway Status of Merck collaboration ~14 bevacizumab (VEGF) combo PAOLA-1 • Collaboration infrastructure set up Potential launches Data 2019+ and agreed cediranib (VEGFr1) combo Data 2019 E
Slide 13: Lynparza: Next-generation combinations underway
Lynparza Next-generation combinations underway Lynparza + Imfinzi Lynparza + novel DDR MEDIOLA Phase II trial VIOLETTE Phase II trial Ovarian cancer n=30 (3rd-line and later Lynparza + platinum-sensitive, ATR (AZD6738) gBRCAm) (n=150) Breast cancer n=38 ✓ (1st to 3rd-line HER2- negative, non-platinu
Slide 14: Lung cancer: Tagrisso and Imfinzi
Lung cancer: Tagrisso and Imfinzi Early-stage disease Late-stage disease Stage I-III Stage III Stage IV 1st line Stage IV 2nd line Total 155k patients Total 105k patients Total 370k patients Total 250k patients E.g. Wild type Imfinzi’s Tagrisso’s MYSTIC, ADAURA trial PEARL trials Imfinzi’s Wild type
Slide 15: Lung cancer: Tagrisso
Lung cancer: Tagrisso Potential to transform EGFR-mutated lung cancer Establish in 2nd line Expand to 1st line Extend to adjuvant ~10 months ~19 months Up to 3 years Progression-free survival Progression-free survival Treatment duration AURA3 trial in 2nd-line T790M NSCLC FLAURA trial in 1st-line EG
Slide 16: Lung cancer: Imfinzi
Lung cancer: Imfinzi Durable advantage in Stage III, unresectable NSCLC PACIFIC PFS by BICR PACIFIC regulatory status Lifecycle programme (Intention-to-treat population) already well underway Eight Regulatory submissions1 • PACIFIC • Final OS data in 2019 Regulatory decisions anticipated in 2018 • I
Slide 17: Lung cancer: Trials in non-small cell lung cancer
Lung cancer: Trials in non-small cell lung cancer Overview of medicines in current and ongoing Phase IIIs PEARL Patients with no (2020) EGFR-mutated or POSEIDON CTx ALK-translocated (2019) tumours ~75-80% of patients NEPTUNE (H2 2018) Imfinzi + treme Imfinzi ADJUVANT (2020) PACIFIC1 (2019 final OS)
Slide 18: Imfinzi beyond NSCLC
Imfinzi beyond NSCLC Prioritising opportunities in select cancers with unmet need Head & neck cancer Lynparza combinations (Phase II MEDIOLA trial) KESTREL 1st line (H1 2018) Small-cell lung cancer (WCLC 2017) EAGLE 2nd line (H1 2018) Breast cancer multiple lines (SABCS 2017) Liver cancer (HCC) Gast
Slide 19: Calquence: AstraZeneca's entry into blood-cancer treatment
Calquence AstraZeneca’s entry into blood-cancer treatment Best-in-class BTK Calquence (acalabrutinib) Upcoming news flow inhibitor in MCL US-approved in MCL in haematology CLL randomised Phase III data in 2019 • For adults with previously- treated mantle cell lymphoma Phase IB/II II✓ Phase Phase III
Slide 20: Agenda
Agenda Oncology Cardiovascular and Metabolic Diseases Pancreatic beta cells at different stages of regeneration: AstraZeneca is investing in research that could Respiratory stimulate the regeneration of beta cells in the pancreas with the aim of stopping the progression of, or reversing, the course
Slide 21: CVMD: Changing clinical practice today, pushing the boundaries of science tomorrow
CVMD: Changing clinical practice today, and pushing the boundaries of science tomorrow 3 + Stop disease and Heart failure ------------- regenerate organs Atherosclerosis 2 + Bring cardiovascular (CV) protection and Metabolism 1 Deliver superior slow down disease progression efficacy in core indicati
Slide 22: Brilinta: Opportunities outside acute coronary syndrome
Brilinta Opportunities outside acute coronary syndrome THEMIS Status T2DM1 with established CAD2 THEMIS Brilinta Primary endpoint: • 19,200 patients with type-2 diabetes 60mg BID Prevention of major Patients >50 years + drug CV events treated for T2DM + high risk • Enrolment completed in 2016 for CV
Slide 23: Farxiga: Focus on establishing CV benefit in type-2 diabetes
Farxiga Focus on establishing CV benefit in type-2 diabetes CVD-REAL DECLARE Phase III trial Real-world observational study SGLT2 inhibitors vs other glucose-lowering medicines • Primary efficacy endpoints • Superiority for MACE (CV death, non-fatal 51% 39% 46% myocardial infarction or non-fatal str
Slide 24: Farxiga: Extending the science into type-1 diabetes
Farxiga Extending the science into type-1 diabetes DEPICT-1 DEPICT Phase III programme Change in HbA1c and bodyweight over 24 weeks DEPICT-1 • HbA1c reduction at 24 weeks of HbA1c reduction Bodyweight reduction 0.42-0.45% across two doses1 • Daily insulin dose reduction 8.8- 13.2% • Weight loss of 2
Slide 25: Farxiga: Extending into heart failure and chronic kidney disease
Farxiga Extending the science into heart failure and chronic kidney disease 38 million 200 million 422 million patients worldwide live with heart patients worldwide live with chronic patients worldwide live with diabetes failure (HF) kidney disease (CKD) (the majority with type-2 diabetes)1-3 A larg
Slide 26: Bydureon: BCise and DURATION-7/8
Bydureon BCise and DURATION-7/8 Bydureon BCise autoinjector DURATION-7/8 Phase III trials • New, easy-to-use, once weekly medicine for type-2 DURATION-7 (insulin + Bydureon) diabetes • 25.1% of patients achieved target HbA1C levels. Lower fasting glucose levels and reduced body weight • Up to 1.4% H
Slide 27: ZS-9: Potential best-in-class treatment for hyperkalaemia
ZS-9 (sodium zirconium cyclosilicate) Potential best-in-class treatment for hyperkalaemia Disease burden and Differentiated medicine unmet medical need and regulatory status Properties 40-50% • 5-10g once daily; odourless/tasteless • Non-systemically absorbed • One-hour onset of action patients with
Slide 28: Roxadustat: Potential first-in-class oral HIF-PHD inhibitor for anaemia of CKD
Roxadustat Potential first-in-class oral HIF-PHD inhibitor for anaemia of CKD Phase III programme Targeting a competitive medicine profile Non-dialysis patients (against placebo) • Superior haemoglobin increase Patient population Company Phase III trial • Non-inferior on major adverse CV events (MAC
Slide 29: Agenda
Agenda Oncology Cardiovascular and Metabolic Diseases Pancreatic beta cells at different stages of regeneration: AstraZeneca is investing in research that could Respiratory stimulate the regeneration of beta cells in the pancreas with the aim of stopping the progression of, or reversing, the course
Slide 30: COPD
COPD A common, preventable and treatable disease characterised by persistent respiratory symptoms and airflow limitation ~330 million 3 million patients worldwide affected by COPD deaths from COPD annually 3rd $32 billion predicted to be the third-leading in the US, COPD accounts for $32bn cause of
Slide 31: COPD: Bevespi and PT010 next-generation inhaled medicines
COPD Bevespi and PT010 next-generation inhaled medicines Next-generation technology Bevespi Aerosphere PT010 Dual bronchodilator Dual bronchodilator plus ICS1 • First medicine using Aerosphere Phase III programme underway and delivered in a pressurised metered-dose inhaler (pMDI) • First data readou
Slide 32: Asthma: Expanding to encompass more treatment guideline steps
Asthma Expanding to encompass more treatment guideline steps ~315 million 1 in 10 patients patients suffer from asthma worldwide with asthma have severe asthma, requiring high-dose ICS-based therapy plus other asthma medicines Step 5 Step 4 Step 3 Preferred Step 1 Step 2 Refer for add-on controller
Slide 33: Asthma: Fasenra
Asthma: Fasenra Targeted, anti-eosinophil medicine; recently launched in the US Fasenra (benralizumab) received US FDA Lifecycle programme approval for severe eosinophilic asthma1 Asthma 51% 2 159mL 3 75% 5 • Autoinjector; GRECO Phase III reduction in the annual Significant improvement in median red
Slide 34: Asthma: Tezepelumab
Asthma: Tezepelumab Significantly reduced asthma exacerbations for a broad population Functions of thymic stromal First-in-class treatment that Late-stage development lymphopoietin (TSLP) blocks TSLP - an upstream driver of inflammation in asthma Phase IIb PATHWAY trial positive • Epithelial-derived
Slide 35: Agenda
Agenda Oncology Cardiovascular and Metabolic Diseases Pancreatic beta cells at different stages of regeneration: AstraZeneca is investing in research that could Respiratory stimulate the regeneration of beta cells in the pancreas with the aim of stopping the progression of, or reversing, the course
Slide 36: Anifrolumab: Lupus Phase III on track for H2 2018
Anifrolumab Lupus Phase III on track for H2 2018 Large unmet Systemic Lupus Erythematosus Phase III SLE programme patient need (SLE) Responder Index 4 now fully recruited including OCS taper at day 365 Prevalence Placebo 300mg 1,000mg • Phase III trials TULIP 1 and SLE TULIP 2 both fully recruited •
Slide 37: Lanabecestat: Alzheimer's disease programme and partnership on track
Lanabecestat Alzheimer’s disease programme and valuable partnership on track Unmet need not addressed Lanabecestat depletes amyloid Late-stage development by any effective medicines beta in cerebral spinal fluid • First Phase II/III trial AMARANTH (early Alzheimer’s) completed recruitment • Interim
Slide 38: Late-stage pipeline news flow in 2018 and 2019
Late-stage pipeline news flow in 2018 and 2019 Unlocking and realising the potential of new medicines H1 2018 H2 2018 2019 Regulatory decision Lynparza Lynparza - breast cancer (JP) - - ovarian cancer 2L (EU, JP) Tagrisso - lung cancer (EU, JP) - breast cancer (US) Imfinzi - lung cancer (PACIFIC) (E
Slide 39: Summary
Summary 2017 a great year overall; 2018 news flow on track 2017 key opportunities being delivered, including: 2018 key opportunities on track • Tagrisso FLAURA trial under regulatory • Oncology lifecycle programmes for reviews Lynparza, Tagrisso, Imfinzi, Calquence • Imfinzi PACIFIC trial under regu
Slide 40: Agenda
Agenda Oncology Cardiovascular and Metabolic Diseases Pancreatic beta cells at different stages of regeneration: AstraZeneca is investing in research that could Respiratory stimulate the regeneration of beta cells in the pancreas with the aim of stopping the progression of, or reversing, the course
Slide 41: Q&A
41 Q&A
Slide 42: Use of AstraZeneca webcast, conference call and presentation slides
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 availab
Slide 43: Investor science event: Late-stage pipeline webcast
Investor science event: Late-stage pipeline webcast 14 December 2017