Astrazeneca Plc · LSE:AZN
Astrazeneca — Investor Day (December 2016)
35 slides from Astrazeneca's investor day presentation, Dec 15, 2016
Slide 1: Late-stage pipeline investor science webcast
Late-stage pipeline investor science webcast Sean Bohen, EVP, Global Medicines Development and Chief Medical Officer 15 December 2016
Slide 2: Forward-looking statement
Forward-looking statement 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, p
Slide 3: Agenda & introduction
Agenda & introduction Presenter Sean Bohen Executive Vice President, Global Medicines Development and Chief Medical Officer Oncology Cardiovascular & Metabolic Diseases Respiratory Participants for Q&A Elisabeth Björk Colin Reisner Rob Iannone Head of Respiratory, Global Head of Cardiovascular and H
Slide 4: Agenda
Agenda Introduction Oncology Cardiovascular & Metabolic Diseases Respiratory Other opportunities News flow 2017-2018 4
Slide 5: Key 2016 news flow from late-stage pipeline
Key 2016 news flow from late-stage pipeline Supporting on-going pipeline-driven transformation Lynparza Tagrisso durvalumab Brilique Tagrisso Bevespi Qtern ZS-9 durvalumab prostate cancer lung cancer bladder cancer post MI lung cancer COPD type-2 diabetes hyperkalaemia bladder cancer Breakthrou
Slide 6: Key Phase III medicines & lifecycle
Key Phase III medicines & lifecycle Rich pipeline across three therapy areas Cardiovascular & Metabolic Oncology Respiratory Diseases durvalumab1 ZS-91 benralizumab multiple cancers hyperkalaemia severe, uncontrolled asthma / COPD durva + treme roxadustat tralokinumab multiple cancers anaemia sever
Slide 7: Key Phase III medicines & lifecycle
Key Phase III medicines & lifecycle Rich pipeline across three therapy areas Primary focus today Cardiovascular & Metabolic Oncology Respiratory Diseases durvalumab1 ZS-91 benralizumab multiple cancers hyperkalaemia severe, uncontrolled asthma / COPD durva + treme roxadustat tralokinumab multiple c
Slide 8: Agenda
Agenda Introduction Oncology Cardiovascular & Metabolic Diseases Respiratory Other opportunities News flow 2017-2018 8
Slide 9: Lynparza
Lynparza First-in-class medicine with differentiated development programme Ovarian cancer Development programme Study 19 SOLO-2 Phase III data readouts / anticipated PROFOUND* Long-term survival benefit prostate cancer significantly established in BRCA- mutated metastatic ovarian PAOLA bevacizu
Slide 10: Non-small cell lung cancer (NSCLC)
Non-small cell lung cancer (NSCLC) Potential to benefit the majority of patients Typical non-Asian NSCLC-patient segmentation Typical Asian NSCLC-patient segmentation ALK inhibitors ALK inhibitors EGFR inhibitors EGFR inhibitors IO market IO market opportunity opportunity durvalumab and durvalum
Slide 11: Tagrisso
Tagrisso First randomised Phase III trial to demonstrate superiority AURA3 - 2L T790M NSCLC Investigator assessment1 PFS by Tagrisso Chemo investigator (N=279) (N=140) Median PFS, 10.1 4.4 months (95% (8.3;; 12.3) (4.2;; 5.6) CI) 0.30 (0.23;; 0.41) HR (95% CI) p<0.001 Tagrisso Platinum-pemetrexed
Slide 12: Tagrisso
Tagrisso Expanding beyond 2L T790M to 1L EGFRm Tagrisso crosses the blood-brain barrier Potential in 1L EGFRm NSCLC Tony Mok, discussion of Tagrisso data, ELCC, Geneva, Switzerland 13 April 2016 • The only EGFR tyrosine kinase inhibitor to cross the blood-brain barrier at any significant level • B
Slide 13: Tagrisso
Tagrisso Improving lives of patients with EGFRm lung cancer Unprecedented speed 2016 milestones Development programme Phase III data readout / anticipated FPD1 Mar 2013 Approvals Tagrisso 32 months • Feb - T790M (EU) FDA app. Nov 2015 • Mar - 2L T790M (JP) • Sep - ctDNA2 (US) FPD Jun 1998 Earlier
Slide 14: Durvalumab and durva + treme
Durvalumab and durva + treme Efficacy well established in NSCLC Monotherapy - Study 1108 - NSCLC 1L cohort Dynamic internal data Study 1108 (durvalumab monotherapy, multiple cancers), n=1,014 • NSCLC cohorts across 1L, 2L, 3L+ • 2016 data presentations at ASCO and ESMO • Data maturity now allows f
Slide 15: Durvalumab and durva + treme
Durvalumab and durva + treme NSCLC 1L MYSTIC trial provides optionality along key parameters PD-L1+ durvalumab and PFS OS durva + treme All Comers 15 Antibody blocking inhibitory signals from the tumour to cells of the immune system resulting in enhanced anti-tumour immunity
Slide 16: Durvalumab
Durvalumab Bladder cancer potential first approval Q2 2017 First-ever BLA1 submission for AstraZeneca Proposed indication • Patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease has progressed during or after one standard platinum-based regimen Clinical trials • BLA
Slide 17: Durvalumab and durva + treme
Durvalumab and durva + treme Key Phase III news flow;; H1 2017 key to success = durvalumab = durva +/- treme ✔ = fully recruited Bladder cancer DANUBE (UC1) 1L Head & neck cancer KESTREL EAGLE (HNSCC2) 1L 2L Lung cancer (NSCLC) MYSTIC 1L (PFS) ✔ MYSTIC 1L (final OS) ✔ ARCTIC 3L PD-L1 neg. ✔ PACIFI
Slide 18: Acalabrutinib
Acalabrutinib Differentiated and potential best-in-class BTK inhibitor R/R CLL*: ASH 2015 FL CLL*: ASCO 2016 Upcoming news flow n (%) All cohorts n (%) All cohorts Indication Line of therapy;; trial design Phase (n=72) (n=72) Relapsed/refractory III acalabrutinib vs. ibrutinib CR 0 (0) CR 0 (0) Fr
Slide 19: Agenda
Agenda Introduction Oncology Cardiovascular & Metabolic Diseases Respiratory Other opportunities News flow 2017-2018 19
Slide 20: Cardiovascular & Metabolic Diseases strategy
Cardiovascular & Metabolic Diseases strategy Reducing cardiovascular morbidity, mortality and organ damage by addressing multiple risk factors Cardiovascular Metabolic Chronic Kidney Disease CHD/ Heart Disease Symptomatic Dyslipidaemia Diabetes Obesity ACS failure progression treatment Regeneration
Slide 21: Brilinta
Brilinta Refocusing on coronary disease after two recent disappointments Phase III SOCRATES Phase III EUCLID Phase III THEMIS Brilinta versus aspirin in Acute Ischemic Stroke Brilinta versus clopidogrel in symptomatic Brilinta versus placebo in type-2 diabetes and (AIS) or Transient Ischemic Attack
Slide 22: Farxiga
Farxiga Backbone of the diabetes franchise DURATION-8 Commitment to Farxiga Farxiga + Bydureon DECLARE cardiovascular outcomes trial • Fully recruited: ~10,000 patients with no prior index event (primary prevention) and ~7,000 patients who have suffered an index event (secondary prevention) Additio
Slide 23: Bydureon
Bydureon Innovation to re-energise potential in type-2 diabetes New device Phase III trials to support regulatory submission • DURATION-NEO 1 • DURATION-NEO 2 Regulatory submission H1 2017 Single-chamber auto-injector Dual-chamber pen Single-dose tray 2010 2014 2017 EXSCEL cardiovascular out
Slide 24: ZS-9 (sodium zirconium cyclosilicate)
ZS-9 (sodium zirconium cyclosilicate) Potential best-in-class treatment for hyperkalaemia Disease burden and unmet Differentiated medicine Regulatory status medical need 40-50% US • Q3 2016: Regulatory resubmission accepted patients with chronic kidney • Q1 2017: Anticipated disease have hyperka
Slide 25: Roxadustat
Roxadustat Potential first-in-class oral HIF-PHD inhibitor for anaemia in CKD and end-stage renal disease Phase III development programme Regulatory status Patient population Company Phase III trial ANDES CN • Q4 2016: Rolling submission Anaemia in CKD OLYMPUS • Fibrogen utilising domestic regul
Slide 26: Agenda
Agenda Introduction Oncology Cardiovascular & Metabolic Diseases Respiratory Other opportunities News flow 2017-2018 26
Slide 27: Respiratory
Respiratory Expanding to encompass more treatment guideline steps AstraZeneca today AstraZeneca from 2017-2018 Step 5 Step 4 Step 3 Preferred Step 1 Step 2 Refer for add-on controller Low-dose Med/High treatment choice Low-dose ICS ICS/LABA** ICS/LABA e.g. novel biologics Other Leukotriene recep
Slide 28: Benralizumab
Benralizumab Targeted, anti-eosinophil medicine Phase III data delivered differentiated profile in patients with severe, uncontrolled asthma with an eosinophilic phenotype1,2 Annual asthma exacerbation rate SIROCCO (48 weeks) CALIMA (56 weeks) 315 million patients suffer from asthma worldwide 1 in
Slide 29: Other respiratory medicines
Other respiratory medicines Portfolio to provide expanded options for patients Tralokinumab PT010 Tezepelumab Potential first-in-class anti IL-13 Fixed-dose combination medicine Anti-thymic stromal lymphopoeitin (TSLP) for severe, uncontrolled asthma for COPD and asthma for moderate to severe a
Slide 30: Agenda
Agenda Introduction Oncology Cardiovascular & Metabolic Diseases Respiratory Other opportunities News flow 2017-2018 30
Slide 31: Anifrolumab
Anifrolumab Development programme in lupus enrolling well Delivering benefits to patients Systemic Lupus Erythematosus Phase III SLE programme (SLE) Responder Index 4 including ongoing steroids (OCS) taper at day 365 Placebo 300mg 1,000mg • First patient completed;; now in Day 1 60 51.5 52.0 50.0 th
Slide 32: AZD3293 (BACEi)
AZD3293 (BACEi) Alzheimer's disease programme and partnership on track Patients with Alzheimer’s disease Development programme Cerebral spinal fluid (CSF) amyloid beta (Aβ) peptides • April 2016: Phase II AMARANTH trial passed safety review;; continued to Phase III • Ongoing Phase III trials • AMARA
Slide 33: Agenda
Agenda Introduction Oncology Cardiovascular & Metabolic Diseases Respiratory Other opportunities News flow 2017-2018 33
Slide 34: Late-stage pipeline news flow 2017 & 2018
Late-stage pipeline news flow 2017 & 2018 Unlocking and realising potential of new medicine H1 2017 H2 2017 2018 Regulatory decisions Faslodex - breast cancer (1L) (JP) Tagrisso - lung cancer (CN) benralizumab - severe, uncontrolled asthma durvalumab - bladder cancer (US) Tagrisso - lung cance
Slide 35: Q&A
Q&A