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Astrazeneca Full year and_q4_2016_results_presentation

The document provides an overview of AstraZeneca's full-year and Q4 2016 results presentation. It notes that total revenue was primarily impacted by generic competition for Crestor and the tail-end of Nexium's loss of exclusivity in the US. The "New AstraZeneca" grew by 6% in FY 2016 and Q4, led by growth in Emerging Markets, Symbicort, and Farxiga. EPS was supported by cost management. 2017 guidance forecasts low-to-mid single digit revenue decline and low-to-mid teens decline in core EPS. The presentation highlights pipeline progress including regulatory filings for Tagrisso, Durvalumab and Faslodex.

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Full-­Year  and  Q4  2016  Results Presentation  and  webcast  for  investors  and  analysts,  London,  UK 2  February  2017
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;; the risk of substantial adverse litigation/government investigation claims and insufficient insurance coverage;; effects of patent litigation in respect of IP rights;; exchange rate fluctuations;; the risk that R&D will not yield new products that achieve commercial success;; the risk that strategic alliances and acquisitions, including licensing and collaborations, will be unsuccessful;; the impact of competition, price controls and price reductions;; taxation risks;; the risk of substantial product liability claims;; 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 of delay to new product launches;; the difficulties of obtaining and maintaining regulatory approvals for products;; 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 risk that new products do not perform as we expect;; failure to achieve strategic priorities or to meet targets or expectations;; 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 risk of misuse of social medial platforms and new technology;; the risks associated with developing our business in emerging markets;; the risk of illegal trade in our products;; the risks from pressures resulting from generic competition;; the risk of failure to successfully implement planned cost reduction measures through productivity initiatives and restructuring programmes;; economic, regulatory and political pressures to limit or reduce the cost of our products;; the risk that regulatory approval processes for biosimilars could have an adverse effect on future commercial prospects;; the impact of failing to attract and retain key personnel and to successfully engage with our employees;; the impact of increasing implementation and enforcement of more stringent anti-­bribery and anti-­corruption legislation;; and the risk of failure of information technology and cybercrime. Nothing in this presentation / webcast should be construed as a profit forecast. 2 Forward-­looking  statements
Today’s  presenters 3 Sean  Bohen Executive  Vice  President,   Global  Medicines  Development   and  Chief  Medical  Officer Pascal  Soriot Executive  Director  and Chief  Executive  Officer Marc  Dunoyer Executive  Director  and Chief  Financial  Officer Mark  Mallon Executive  Vice  President,   Global  Portfolio  and  Product,   Global  Medical  Affairs,   Corporate  Affairs  and   International  West
4 Agenda Overview Growth  Platforms Finance Pipeline  and  news  flow Closing  and  Q&A
Business  &  Financials Total  Revenue  primarily  reflected  Crestor generics,  lack  of  US  FluMist and  the  tail  of  the  US  Nexium loss  of  exclusivity ’New  AstraZeneca’  grew  by  6%  in  FY  and  by  6%  in  Q4 • Emerging  Markets  performed  well  overall • Farxiga and  Symbicort global  leaders  in  volume  market  share – Sequential  improvement  in  Respiratory;;  encouraging  US  Bevespi launch – Farxiga largest  AZ  Diabetes  medicine • Tagrisso $423m  in  its  first  full  year EPS  supported  by  continued  active  cost  management  and  sharper  focus  on  three  therapy  areas • Core  R&D  up  by  5%;;  continued  pipeline  investment  and  two  recent  acquisitions • Core  SG&A  down  by  9%;;  in  line  with  commitments 2017  guidance • Total  Revenue:  Low-­to-­mid  single-­digit  percentage  decline • Core  EPS:  Low-­to-­mid  teens  percentage  decline FY  expectations  met;;  pipeline-­driven  transformation  continues 5 Highlights Growth  rates  at  CER  (Constant  Exchange  Rates)  and  for  FY  unless  otherwise  stated.  Guidance  at  CER
Pipeline  in  Q4 Oncology •  Durvalumab  -­ bladder  cancer:  Regulatory  submission  (US),  Priority  Review  (US) •  Tagrisso -­ lung  cancer  (AURA3  trial):  Regulatory  submissions  (US,  EU),   Priority  Review  (US) •  Faslodex -­ breast  cancer  (1L):  Regulatory  submissions  (US,  EU) Cardiovascular  & •  Bydureon -­ type-­2  diabetes:  Positive  Phase  III  trial  DURATION-­7  (with  insulin) Metabolic  Diseases Respiratory •  Benralizumab  -­ severe,  uncontrolled  asthma:  Regulatory  submissions  (US,  EU)   Other •  Alzheimer’s  disease  alliance  with  Lilly  expanded FY  expectations  met;;  pipeline-­driven  transformation  continues 6 Highlights;;  continued
New  AstraZeneca  is  emerging  from  patent  losses 7 Total  Revenue:  Inflection  point  approaching Absolute  values  at  CER.  Growth  rate  at  CER 0 5,000 10,000 15,000 20,000 25,000 30,000 FY  2012 FY  2013 FY  2014 FY  2015 FY  2016 US  patent  losses   (Crestor/Nexium/Seroquel) Other  out-­of-­patent  medicines (outside  Emerging  Markets) Externalisation   Emerging  Markets (established  medicines) Respiratory Oncology Brilinta &  Diabetes +6%  FY $bn
8 2017:  Potential  to  be  a  defining  year 2012 2013 2014 2015 2016 2017E durvalumab benralizumab Launches  of  new  medicines from  main  therapy  areas Some  of  the  key   opportunities  in  2017 durvalumab  / durva  +  treme NSCLC1 1L MYSTIC  data durvalumab bladder  cancer reg.  decision Tagrisso NSCLC  1L FLAURA  data benralizumab asthma reg.  decision Lynparza multiple  cancers data  readouts acalabrutinib blood  cancers fast-­to-­market opportunity ZS-­9 hyperkalaemia reg.  decision 1.  NSCLC  =  Non-­Small  Cell  Lung  Cancer
Rich  pipeline  across  three  therapy  areas 9 Key  Phase  III  medicines  &  lifecycle 1.  Under  regulatory  review  in  major  jurisdiction      2.  Life-­cycle  development  programme Status  as  of  2 February  2017 Oncology Cardiovascular  &  Metabolic   Diseases Respiratory durvalumab1 multiple  cancers ZS-­91 hyperkalaemia benralizumab1 severe,  uncontrolled  asthma / COPD durva  +  treme multiple  cancers roxadustat anaemia tralokinumab severe,  uncontrolled  asthma acalabrutinib blood  cancers PT010 COPD /  asthma moxetumomab leukaemia selumetinib thyroid  cancer Other Lynparza2 multiple  cancers anifrolumab lupus Tagrisso1,2 lung  cancer AZD3293 Alzheimer’s  disease
10 Agenda Overview Growth  Platforms Finance Pipeline  and  news  flow Closing  and  Q&A
Q4 2016   $m %   change %  Total Revenue FY  2016 $m %   change %  Total   Revenue Growth  Platforms 3,728 3 67 14,491 5 63 Emerging  Markets 1,486 7 -­ 5,794 6 -­ Respiratory 1,210 (5) -­ 4,753 (3) -­ Diabetes 598 3 -­ 2,427 11 -­ Japan 591 (5) -­ 2,184 (3) -­ Brilinta 236 37 -­ 839 39 -­ New  Oncology1 216 n/m -­ 664 n/m -­ Emerging  Markets  improving;;  strong  growth  in  Oncology 11 Growth  Platforms:  Stable  performance  overall 1.  New  Oncology  comprises  Lynparza,  Iressa (US)  and  Tagrisso Absolute  values  at  actual  exchange  rates.  Growth  rates  at  CER
Q4 2016   $m %   change %  Total Revenue FY  2016 $m %   change %  Total   Revenue Growth  Platforms 3,728 3 67 14,491 5 63 Emerging  Markets 1,486 7 -­ 5,794 6 -­ Respiratory 1,210 (5) -­ 4,753 (3) -­ Diabetes 598 3 -­ 2,427 11 -­ Japan 591 (5) -­ 2,184 (3) -­ Brilinta 236 37 -­ 839 39 -­ New  Oncology 216 n/m -­ 664 n/m -­ Emerging  Markets  improving;;  strong  growth  in  Oncology 12 Growth  Platforms:  Stable  performance  overall Absolute  values  at  actual  exchange  rates.  Growth  rates  at  CER Today’s   focus
• Well-­balanced  business • China  less  than  half  of  total • Other  key  markets • Russia  +13% • Brazil  +2% • Challenging  conditions  in  some  markets • Saudi  Arabia;;  Venezuela • New  medicines/pipeline  well  positioned • China  approvals  expected  for  Forxiga (H1  2017)   and  Tagrisso (H2  2017) 13 Emerging  Markets Good  fundamentals;;  balanced  performance Product  Sales  growth Long-­term  target:  Mid  to  high  single-­digit Improved  performance  overall;;  softness  in  some  markets Emerging  Markets China Growth  rates  at  CER  and  for  FY  unless  otherwise  stated 4% 8% 12% 12% 0% 5% 10% 15% FY  2012 FY  2013 FY  2014 FY  2015 7% 6% 0% 2% 4% 6% 8% Q4  2016 FY  2016 17% 19% 22% 15% 0% 5% 10% 15% 20% 25% FY  2012 FY  2013 FY  2014 FY  2015 8% 10% 0% 2% 4% 6% 8% 10% 12% Q4  2016 FY  2016
Symbicort continued  as  global  leader  in  competitive  market 14 Respiratory US  -­16% • Volume  growth  offset  by  continued   competitive  pricing  environment • Bevespi now  available  with  solid   access Europe  -­4% • Volume  growth  with  overall  stable   competitive  environment • Continued  launches  of  new  medicines • Q4  growth  5% Emerging  Markets  +17% • Increase  in  market  uptake  continues • Pulmicort +21% • Symbicort +10% US,  Europe  competitive Emerging  Markets  growth Symbicort global  leader  and Europe  volume  has  stabilised Q4  improved  sequentially $m Source:  QuintilesIMS Symbicort Pulmicort Others 0 200 400 600 800 1,000 1,200 1,400 Q4  2016 19% +8% -­13% 0 1,000 2,000 3,000 4,000 5,000 FY  2016 24% +8% -­10% -­5% -­3% Global  market  share  volume Europe  market  share  volume 30.5% 27.7% 25% 30% 35% Sep-­15 Oct-­15 Nov-­15 Dec-­15 Jan-­16 Feb-­16 Mar-­16 Apr-­16 May-­16 Jun-­16 Jul-­16 Aug-­16 Sep-­16 Oct-­16 Nov-­16 Symbicort Competitor 32.5% 25.4% 0% 20% 40% Sep-­15 Oct-­15 Nov-­15 Dec-­15 Jan-­16 Feb-­16 Mar-­16 Apr-­16 May-­16 Jun-­16 Jul-­16 Aug-­16 Sep-­16 Oct-­16 Nov-­16 Symbicort Competitor Absolute  values  at  actual  exchange  rates.  Growth  rates  at  CER  and  for  FY   unless  otherwise  stated
First  Pearl  medicine  available  in  the  US  for  COPD1 15 Respiratory:  Bevespi Aerosphere launched • Intelligent  formulation  for  a  pMDI  using  patented CO-­SUSPENSION™  Delivery  Technology2,3 • First  and  only  LAMA/LABA  in  the  familiar  pMDI  device2,4 • Maximise  bronchodilation5… achieved  a  381-­mL   improvement  in  peak  inspiratory  capacity6 1.  Bevespi is  indicated  for  the  long-­term,  maintenance  treatment  of  airflow  obstruction  in  patients  with  COPD,  including  chronic  bronchitis and/or  emphysema 2.,  3.,  4.,  6.  References  available  upon  request 5.  Improvements  in  lung  function  relative  to  its  individual  components  and  placebo  in  two  24-­week  pivotal  trials
Global  growth  with  focus  on  Farxiga 16 Diabetes US  +5% • Growing  market,  but  intense   competition  for  market  share • Farxiga +75%  from  improved   access  and  market-­share  gains Europe  +15% • Strong  growth  in  focus  medicine   Forxiga (+52%);;  and  Bydureon (+23%) • Forxiga leading  the  SGLT2  class Emerging  Markets  +25% • Strong  growth  in  Forxiga (+96%) Growth  in  all  regions Farxiga global  leader  in SGLT2  class  by  volume Farxiga largest  AstraZeneca Diabetes  medicine Source: QuintilesIMS $m Farxiga Onglyza Bydureon Byetta 0 100 200 300 400 500 600 700 Q4  2016 -­22% -­8% -­21% +57% 0 500 1,000 1,500 2,000 2,500 3,000 FY  2016 -­19% 0% -­6% +72% +3% +11% 41.8% 24.6% 24.5% 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% Sep-­15 Oct-­15 Nov-­15 Dec-­15 Jan-­16 Feb-­16 Mar-­16 Apr-­16 May-­16 Jun-­16 Jul-­16 Aug-­16 Sep-­16 Oct-­16 Nov-­16 Farxiga Competitor  1 Competitor  2 Absolute  values  at  actual  exchange  rates.  Growth  rates  at  CER  and  for  FY   unless  otherwise  stated
Performance  reduced  by  April  price  cuts;;  transformation  underway 17 Japan Tagrisso starting  to  change the  Japanese  business Solid  in-­market  performance improved  market-­share  rank Q4  Product  Sales  reduced  by   Crestor inventory  reductions Absolute  values  at  actual  exchange  rates.  Growth  rates  at  CER Long-­term  target  for  Japan: Low  single-­digit  growth $m Crestor Nexium Symbicort Others 0 100 200 300 400 500 600 700 Q4  2016 -­8% +27% +1% -­15% 0 500 1,000 1,500 2,000 2,500 FY  2016 -­5% +7% -­4% 0% -­5% -­3% #6 2016  AstraZeneca  position  in   Japan  market  company  rankings #12   2012  AstraZeneca  position  in   Japan  market  company  rankings 0 15 28 39 0 5 10 15 20 25 30 35 40 45 Q1  2016 Q2  2016 Q3  2016 Q4  2016 $m
Solid  growth  continued 18 Brilinta US • Positive  momentum  from  changes  to   competitor’s  label • 60mg  ~10%  of  new  prescriptions Europe • Increase  in  hospital-­discharge  share   and  market-­share  gains • 60mg  launched  in  most  of  Europe Emerging  Markets • 147%  growth  in  China,  with  NRDL1 review  underway • Other  key  markets • Russia  +70% • Brazil  +17% Strong  execution  of lifecycle  management Growth  across all  markets Source:  QuintilesIMS Brilinta reached  peak  US new  prescription  share 1.  NRDL  =  National  Reimbursement  Drug  List $m US Europe EMs E.  RoW 0 50 100 150 200 250 Q4  2016 +62% +13% +50% 0 200 400 600 800 1,000 FY  2016 +37% +80% +15% +45% +39% 14.6% 6.9% 0% 2% 4% 6% 8% 10% 12% 14% 16% Brilinta Competitor  1 Absolute  values  at  actual  exchange  rates.  Growth  rates  at  CER  and  for  FY   unless  otherwise  stated
Launches  progressing  well 19 New  Oncology Tagrisso (lung  cancer) Tagrisso 2016 key  milestones Absolute  values  at  actual  exchange  rates Lynparza (ovarian  cancer) $m $m US Europe EMs E.  RoW US Europe EMs E.  RoW 0 20 40 60 80 100 120 140 160 Q1  2016 Q2  2016 Q3  2016 Q4  2016 0 50 100 150 200 250 FY  2015 FY  2016 $423m A  strong  first  year  for  Tagrisso 46 Number  of  countries  with  regulatory   approval 12,000 Number  of  patients  treated  with  Tagrisso
20 Agenda Overview Growth  Platforms Finance Pipeline  and  news  flow Closing  and  Q&A
FY  2016 $m %  change %  Total   Revenue Q4  2016 $m %  change %  Total   Revenue Total  Revenue 23,002 (5) 100 5,585 (12) 100 -­ Product  Sales 21,319 (8) 93 5,260 (15) 94 -­ Externalisation  Revenue 1,683 59 7 325 77 6 Gross  Margin 80.8% 10bps -­ 78.0% (310)bps -­ R&D  Expenses 5,890 2 26 1,543 (5) 28 SG&A  Expenses 9,413 (12) 41 1,386 (44) 25 Other  Operating  Income 1,655 12 7 1,120 n/m 20 Tax  Rate 4% -­ -­ 17% -­ -­ EPS $2.77 9 $1.46 93 21 Reported  Profit  &  Loss Absolute  values  at  actual  exchange  rates.  Growth  rates  at  CER Gross  Margin  reflects  Gross  Profit  derived  from  Product  Sales,  divided  by  Product  Sales
22 Reported  to  Core  EPS  explanation Other  adjustments  include  provision  charges  related  to  certain  legal matters  and  fair  value  adjustments  arising  on  acquisition-­related  liabilities Reported  EPS  $2.77 $ FY  2016 Notes Adjustments Restructuring 0.69 Reductions  in  SG&A  reflecting progression  to New  AstraZeneca Intangibles 0.78 Acquisition of  MedImmune;;  Merck US  business  transaction,  others Diabetes  Alliance (0.17) Net  amount  of  intangible  amortisation  and adjustment  to  contingent  consideration Diabetes  Alliance contingent consideration expires in  2025 Other 0.24 Includes legal  provisions  and  discount   unwind  on  Acerta  Pharma  liability Core  EPS  $4.31
FY  2016 $m %  change %  Total   Revenue Q4  2016 $m %  change %  Total   Revenue Total  Revenue 23,002 (5) 100 5,585 (12) 100 -­ Product  Sales 21,319 (8) 93 5,260 (15) 94 -­ Externalisation  Revenue 1,683 59 7 325 77 6 Gross  Margin 82.0% (110)bps -­ 79.3% (260)bps -­ R&D  Expenses 5,631 5 24 1,481 2 27 SG&A  Expenses 8,169 (9) 36 2,050 (14) 37 Other  Operating  Income 1,717 14 7 1,142 n/m 20 Tax  Rate 11% -­ -­ 18% -­ -­ EPS $4.31 (5) $1.21 9 Product  Sales  decline;;  good  progress  on  cost  control 23 Core  Profit  &  Loss Absolute  values  at  actual  exchange  rates.  Growth  rates  at  CER Gross  Margin  reflects  Gross  Profit  derived  from  Product  Sales,  divided  by  Product  Sales
24 Continued  progress  and  focus  on  cost  discipline Material  reduction  in  Core  SG&A  delivered Stabilisation  in  Core  R&D  costs  now  realised • Growth  in  Core  costs • FY  up  by  5%  and  Q4  up  by  2% • Investment  focused  on  a  number  of  potential   medicines  in  pivotal  trials • Material  reduction  in  Core  costs • FY  down  by  9%  and  Q4  down  by  14% • A  base  reflecting  New  AstraZeneca • ~100  basis-­point  reduction  in  the  ratio  to Total  Revenue Absolute  values  and  growth  rates  at  CER 0 1 2 Q1  14 Q2  14 Q3  14 Q4  14 Q1  15 Q2  15 Q3  15 Q4  15 Q1  16 Q2  16 Q3  16 Q4  16 $bn 5%  yoy 0 1 2 3 Q1  14 Q2  14 Q3  14 Q4  14 Q1  15 Q2  15 Q3  15 Q4  15 Q1  16 Q2  16 Q3  16 Q4  16 $bn (9)%  yoy
25 Core  R&D  investment  stabilising • FY  2017  Core  R&D  costs  are  expected   to  be  at  a  similar  level  to  FY  2016 Absolute  values  at  actual  exchange  rates.  Growth  rates  at  CER 0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 2013 2014 2015 2016 Autoimmunity, neuroscience & infection Respiratory Cardiovascular & Metabolic Diseases Oncology 29% 37% 42% 43% 19% 23% 25% 28% 24% 28% 4% 29% 5% 12% 32% 20% Investment  weighted  towards  Oncology Sharper  focus  on  main  therapy  areas
26 FY  2017  guidance  and  capital-­allocation  priorities Guidance  at  CER Guidance Investment  in  the  business Progressive  dividend  policy Strong,  investment-­grade  credit  rating Immediately  earnings-­accretive,  value-­enhancing  opportunities Total   Revenue Low  to  mid  single-­ digit  percentage   decline Core  EPS Low  to  mid  teens   percentage   decline Capital-­allocation  priorities
27 Agenda Overview Growth  Platforms Finance Pipeline  and  news  flow Closing  and  Q&A
Main  therapy  areas 28 Q4  late-­stage  pipeline  highlights • Symbicort -­ asthma: Regulatory  approval  SMART1 (aged   12  to  <18  years) • benralizumab -­ severe,   uncontrolled  asthma:  Regulatory   submissions  (US,  EU) • Alzheimer’s  disease: Expanded  Lilly  alliance  with   MEDI1814  (Aβ42-­selective  mAb) Respiratory • Bydureon -­ type-­2  diabetes: Phase  III  DURATION-­7  trial   (Bydureon +  insulin  vs.  insulin)  met   primary  endpoint • roxadustat -­ anaemia: Initiated  rolling  regulatory   submission  (CN) Cardiovascular  & Metabolic  Diseases • durvalumab -­ bladder  cancer: -­Regulatory  submission  (US) -­Priority  Review  (US) • Tagrisso -­ lung  cancer  (AURA3   trial): -­Regulatory  submission  (US,  EU) -­Priority  Review  (US) • Faslodex -­ breast  cancer  (1L): Regulatory  submission  (US,  EU) • durva +  treme -­ head  &  neck   cancer:  Recruitment  restarted Oncology Other  -­ Neuroscience 1.  SMART  =  Symbicort Maintenance  And  Reliever  Therapy Status  since  the  prior  results  announcement  on  10  November  2016
Progress  across  launched  and  pipeline  medicines 29 Oncology  highlights  from  recent  meetings Tagrisso Phase  III  AURA3  trial:  2L  T790M   NSCLC Durvalumab Phase  II  ATLANTIC  trial:  3L+ metastatic  NSCLC Acalabrutinib Phase  I/II  trial:  Monotherapy  in   patients  intolerant  to  ibrutinib Acalabrutinib Phase  I/II  trial:  Monotherapy  in   patients  with  Richter’s  transformation Faslodex Phase  III  FALCON  trial:  1L  hormone-­ receptor  positive  advanced  breast   cancer
First  randomised  Phase  III  trial  to  demonstrate  superiority 30 Lung  cancer:  Tagrisso 1.  PFS  =  Progression-­Free  Survival 2.  Analysis  of  PFS  by  BICR  was  consistent  with  the  investigator-­based  analysis:  HR  0.28  (95%  CI  0.20;;  0.38),  p<0.001;;  median  PFS  11.0  vs.  4.2  months Source:  WCLC  2016,  abstract  PL03.03 AURA3  -­ 2L  T790M  NSCLC Investigator  assessment2 PFS1 HR  0.30  (95%  CI  0.23;;  0.41),  p<0.001;;  median  PFS  10.1  vs.  4.4   months PFS  by   investigator Tagrisso (N=279) Chemo   (N=140)   Median  PFS,   months  (95%   CI) 10.1 (8.3;;  12.3) 4.4   (4.2;;  5.6) HR  (95%  CI) 0.30  (0.23;;  0.41) p<0.001 Regulatory  submission  status US  ✔ EU  ✔ Priority  Review Tagrisso Platinum-­pemetrexed
Comprehensive  programme  across  the  disease 31 Lung  cancer:  IO  Phase  III  trials  overview ADJUVANT PACIFIC MYSTIC NEPTUNE PEARL  *NEW* ARCTIC Trial  design Stage  Ib-­IIIa Randomised,   controlled durvalumab  vs placebo Stage  III   unresectable Randomised,   controlled durvalumab  vs   placebo 1L EGFR/ALK  wt Non-­sq/sq Randomised,   controlled durvalumab, durva  +  treme  vs SoC 1L  EGFR/ALK  wt Non-­sq/sq Randomised,   controlled durva  +  treme  vs SoC 1L  EGFR/ALK  wt Non-­sq/sq PD-­L1 expressers Randomised,   controlled durvalumab  vs SoC 3L  EGFR/ALK  wt Non-­sq/sq PD-­L1  low Randomised,   controlled durvalumab,   tremelimumab,   durva  +  treme vs   SoC Primary   endpoint(s) DFS1 PFS OS2 PFS OS OS PFS OS PFS OS Data  readout 2020 H2  2017 Mid-­2017  (PFS) 2018  (final  OS) 2018 2020 H1  2017 Recruitment   status Ongoing Fully recruited Fully  recruited Ongoing Ongoing Fully  recruited First  line1.  DFS  =  Disease-­Free  Survival 2.  OS  =  Overall  Survival
=  durvalumab =  durva  +/-­ treme ✔ =  fully  recruited Bladder  cancer (UC1) DANUBE 1L Head  &  neck  cancer KESTREL 1L EAGLE 2L Lung  cancer (NSCLC) MYSTIC 1L  (final  OS) PEARL 1L (Asia) ARCTIC 3L  PD-­L1  neg. PACIFIC Stage  III  unresectable NEPTUNE 1L  (final  OS) ADJUVANT Adjuvant H1  2017 H2  2017 2018 2018+ Potential  leadership  in  IO &  IO-­IO  combinations  across  multiple  cancer  types Phase  III  news  flow;;  H1/mid-­2017  key 32 Durvalumab  and  durva  +  treme ✔ ✔ ✔MYSTIC 1L  (PFS) ✔ 1.  Urothelial  Carcinoma
Unlocking  and  realising  potential  of  new  medicine 33 Late-­stage  pipeline  news  flow  2017  &  2018 H1  2017  /  mid-­2017 H2  2017 2018 Regulatory  decision Faslodex -­ breast  cancer  (1L)  (JP) Tagrisso -­ lung  cancer  (AURA3)  (US) durvalumab -­ bladder  cancer  (US) saxa/dapa -­ type-­2  diabetes  (US) ZS-­9 -­ hyperkalaemia  (US,  EU) Faslodex -­ breast  cancer  (1L)  (US,  EU) Tagrisso -­ lung  cancer  (CN) Tagrisso -­ lung  cancer  (AURA3)  (EU) benralizumab -­ severe,  uncontrolled  asthma  (US) benralizumab -­ severe,  uncontrolled  asthma  (EU) Regulatory  submission Lynparza -­ ovarian  cancer  (2L) acalabrutinib -­ blood  cancer  (US)1 Bydureon -­ autoinjector  (US) Bevespi -­ COPD  (EU) benralizumab -­ severe,  uncontrolled  asthma  (JP) Lynparza -­ breast  cancer durvalumab -­ lung  cancer  (PACIFIC)  (US) durva  +/-­ treme -­ lung  cancer  (MYSTIC) -­ lung  cancer  (ARCTIC) Lynparza -­ ovarian cancer  (1L) Tagrisso -­ lung  cancer  (1L) durva  +/-­ treme -­ head  &  neck  cancer  (KESTREL) -­ head  &  neck  cancer  (EAGLE) -­ bladder  cancer  (DANUBE) moxetumomab -­ leukaemia selumetinib -­ thyroid  cancer Brilinta -­ T2D/CAD2 Bydureon -­ CVOT3 roxadustat -­ anaemia tralokinumab -­ severe,  uncontrolled  asthma Duaklir -­ COPD  (US) PT010 -­ COPD Key  Phase III/II*  data   readouts Lynparza -­ breast  cancer durva  +/-­ treme -­ lung  cancer  (MYSTIC)  (mid-­2017) -­ lung  cancer  (ARCTIC) acalabrutinib -­ blood  cancer*1 Lynparza -­ ovarian  cancer  (1L) Tagrisso -­ lung  cancer  (1L) durvalumab -­ lung  cancer  (PACIFIC) durva  +/-­ treme -­ head  &  neck  cancer  (KESTREL) moxetumomab -­ leukaemia tralokinumab -­ severe,  uncontrolled  asthma durva  +/-­ treme -­ lung  cancer  (NEPTUNE) -­ head  &  neck  cancer  (EAGLE) -­ bladder  cancer  (DANUBE) selumetinib -­ thyroid  cancer Brilinta -­ T2D/CAD Bydureon -­ CVOT roxadustat -­ anaemia4 PT010 -­ COPD anifrolumab -­ lupus 1.  Potential  fast-­to-­market  opportunity  ahead  of  randomised,  controlled  trials 2.  T2D/CAD  =  Type-­2  diabetes/Coronary  Artery  Disease 3.  CVOT  =  Cardio-­Vascular  Outcomes  Trial 4.  AstraZeneca-­sponsored  trials
34 Agenda Overview Growth  Platforms Finance Pipeline  and  news  flow Closing  and  Q&A
• Financials  on  track;;  met  guidance  for  the  year • 12  new  potential  medicines  in  Phase  III/under  registration • Oncology  progressing  ahead  of  expectations – Tagrisso – Immuno-­Oncology • Busy  news  flow  over  next  6-­12  months New  AstraZeneca  emerging  from  patent  cliff 35 Pipeline-­driven  transformation  on  track
36 Q&A
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  +  44  20  3749  5000,  www.astrazeneca.com 37

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Astrazeneca Full year and_q4_2016_results_presentation

  • 1.
    Full-­Year  and  Q4 2016  Results Presentation  and  webcast  for  investors  and  analysts,  London,  UK 2  February  2017
  • 2.
    In order, amongother 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;; the risk of substantial adverse litigation/government investigation claims and insufficient insurance coverage;; effects of patent litigation in respect of IP rights;; exchange rate fluctuations;; the risk that R&D will not yield new products that achieve commercial success;; the risk that strategic alliances and acquisitions, including licensing and collaborations, will be unsuccessful;; the impact of competition, price controls and price reductions;; taxation risks;; the risk of substantial product liability claims;; 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 of delay to new product launches;; the difficulties of obtaining and maintaining regulatory approvals for products;; 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 risk that new products do not perform as we expect;; failure to achieve strategic priorities or to meet targets or expectations;; 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 risk of misuse of social medial platforms and new technology;; the risks associated with developing our business in emerging markets;; the risk of illegal trade in our products;; the risks from pressures resulting from generic competition;; the risk of failure to successfully implement planned cost reduction measures through productivity initiatives and restructuring programmes;; economic, regulatory and political pressures to limit or reduce the cost of our products;; the risk that regulatory approval processes for biosimilars could have an adverse effect on future commercial prospects;; the impact of failing to attract and retain key personnel and to successfully engage with our employees;; the impact of increasing implementation and enforcement of more stringent anti-­bribery and anti-­corruption legislation;; and the risk of failure of information technology and cybercrime. Nothing in this presentation / webcast should be construed as a profit forecast. 2 Forward-­looking  statements
  • 3.
    Today’s  presenters 3 Sean  Bohen Executive Vice  President,   Global  Medicines  Development   and  Chief  Medical  Officer Pascal  Soriot Executive  Director  and Chief  Executive  Officer Marc  Dunoyer Executive  Director  and Chief  Financial  Officer Mark  Mallon Executive  Vice  President,   Global  Portfolio  and  Product,   Global  Medical  Affairs,   Corporate  Affairs  and   International  West
  • 4.
  • 5.
    Business  &  Financials Total Revenue  primarily  reflected  Crestor generics,  lack  of  US  FluMist and  the  tail  of  the  US  Nexium loss  of  exclusivity ’New  AstraZeneca’  grew  by  6%  in  FY  and  by  6%  in  Q4 • Emerging  Markets  performed  well  overall • Farxiga and  Symbicort global  leaders  in  volume  market  share – Sequential  improvement  in  Respiratory;;  encouraging  US  Bevespi launch – Farxiga largest  AZ  Diabetes  medicine • Tagrisso $423m  in  its  first  full  year EPS  supported  by  continued  active  cost  management  and  sharper  focus  on  three  therapy  areas • Core  R&D  up  by  5%;;  continued  pipeline  investment  and  two  recent  acquisitions • Core  SG&A  down  by  9%;;  in  line  with  commitments 2017  guidance • Total  Revenue:  Low-­to-­mid  single-­digit  percentage  decline • Core  EPS:  Low-­to-­mid  teens  percentage  decline FY  expectations  met;;  pipeline-­driven  transformation  continues 5 Highlights Growth  rates  at  CER  (Constant  Exchange  Rates)  and  for  FY  unless  otherwise  stated.  Guidance  at  CER
  • 6.
    Pipeline  in  Q4 Oncology•  Durvalumab  -­ bladder  cancer:  Regulatory  submission  (US),  Priority  Review  (US) •  Tagrisso -­ lung  cancer  (AURA3  trial):  Regulatory  submissions  (US,  EU),   Priority  Review  (US) •  Faslodex -­ breast  cancer  (1L):  Regulatory  submissions  (US,  EU) Cardiovascular  & •  Bydureon -­ type-­2  diabetes:  Positive  Phase  III  trial  DURATION-­7  (with  insulin) Metabolic  Diseases Respiratory •  Benralizumab  -­ severe,  uncontrolled  asthma:  Regulatory  submissions  (US,  EU)   Other •  Alzheimer’s  disease  alliance  with  Lilly  expanded FY  expectations  met;;  pipeline-­driven  transformation  continues 6 Highlights;;  continued
  • 7.
    New  AstraZeneca  is emerging  from  patent  losses 7 Total  Revenue:  Inflection  point  approaching Absolute  values  at  CER.  Growth  rate  at  CER 0 5,000 10,000 15,000 20,000 25,000 30,000 FY  2012 FY  2013 FY  2014 FY  2015 FY  2016 US  patent  losses   (Crestor/Nexium/Seroquel) Other  out-­of-­patent  medicines (outside  Emerging  Markets) Externalisation   Emerging  Markets (established  medicines) Respiratory Oncology Brilinta &  Diabetes +6%  FY $bn
  • 8.
    8 2017:  Potential  to be  a  defining  year 2012 2013 2014 2015 2016 2017E durvalumab benralizumab Launches  of  new  medicines from  main  therapy  areas Some  of  the  key   opportunities  in  2017 durvalumab  / durva  +  treme NSCLC1 1L MYSTIC  data durvalumab bladder  cancer reg.  decision Tagrisso NSCLC  1L FLAURA  data benralizumab asthma reg.  decision Lynparza multiple  cancers data  readouts acalabrutinib blood  cancers fast-­to-­market opportunity ZS-­9 hyperkalaemia reg.  decision 1.  NSCLC  =  Non-­Small  Cell  Lung  Cancer
  • 9.
    Rich  pipeline  across three  therapy  areas 9 Key  Phase  III  medicines  &  lifecycle 1.  Under  regulatory  review  in  major  jurisdiction      2.  Life-­cycle  development  programme Status  as  of  2 February  2017 Oncology Cardiovascular  &  Metabolic   Diseases Respiratory durvalumab1 multiple  cancers ZS-­91 hyperkalaemia benralizumab1 severe,  uncontrolled  asthma / COPD durva  +  treme multiple  cancers roxadustat anaemia tralokinumab severe,  uncontrolled  asthma acalabrutinib blood  cancers PT010 COPD /  asthma moxetumomab leukaemia selumetinib thyroid  cancer Other Lynparza2 multiple  cancers anifrolumab lupus Tagrisso1,2 lung  cancer AZD3293 Alzheimer’s  disease
  • 10.
  • 11.
    Q4 2016   $m %  change %  Total Revenue FY  2016 $m %   change %  Total   Revenue Growth  Platforms 3,728 3 67 14,491 5 63 Emerging  Markets 1,486 7 -­ 5,794 6 -­ Respiratory 1,210 (5) -­ 4,753 (3) -­ Diabetes 598 3 -­ 2,427 11 -­ Japan 591 (5) -­ 2,184 (3) -­ Brilinta 236 37 -­ 839 39 -­ New  Oncology1 216 n/m -­ 664 n/m -­ Emerging  Markets  improving;;  strong  growth  in  Oncology 11 Growth  Platforms:  Stable  performance  overall 1.  New  Oncology  comprises  Lynparza,  Iressa (US)  and  Tagrisso Absolute  values  at  actual  exchange  rates.  Growth  rates  at  CER
  • 12.
    Q4 2016   $m %  change %  Total Revenue FY  2016 $m %   change %  Total   Revenue Growth  Platforms 3,728 3 67 14,491 5 63 Emerging  Markets 1,486 7 -­ 5,794 6 -­ Respiratory 1,210 (5) -­ 4,753 (3) -­ Diabetes 598 3 -­ 2,427 11 -­ Japan 591 (5) -­ 2,184 (3) -­ Brilinta 236 37 -­ 839 39 -­ New  Oncology 216 n/m -­ 664 n/m -­ Emerging  Markets  improving;;  strong  growth  in  Oncology 12 Growth  Platforms:  Stable  performance  overall Absolute  values  at  actual  exchange  rates.  Growth  rates  at  CER Today’s   focus
  • 13.
    • Well-­balanced  business •China  less  than  half  of  total • Other  key  markets • Russia  +13% • Brazil  +2% • Challenging  conditions  in  some  markets • Saudi  Arabia;;  Venezuela • New  medicines/pipeline  well  positioned • China  approvals  expected  for  Forxiga (H1  2017)   and  Tagrisso (H2  2017) 13 Emerging  Markets Good  fundamentals;;  balanced  performance Product  Sales  growth Long-­term  target:  Mid  to  high  single-­digit Improved  performance  overall;;  softness  in  some  markets Emerging  Markets China Growth  rates  at  CER  and  for  FY  unless  otherwise  stated 4% 8% 12% 12% 0% 5% 10% 15% FY  2012 FY  2013 FY  2014 FY  2015 7% 6% 0% 2% 4% 6% 8% Q4  2016 FY  2016 17% 19% 22% 15% 0% 5% 10% 15% 20% 25% FY  2012 FY  2013 FY  2014 FY  2015 8% 10% 0% 2% 4% 6% 8% 10% 12% Q4  2016 FY  2016
  • 14.
    Symbicort continued  as global  leader  in  competitive  market 14 Respiratory US  -­16% • Volume  growth  offset  by  continued   competitive  pricing  environment • Bevespi now  available  with  solid   access Europe  -­4% • Volume  growth  with  overall  stable   competitive  environment • Continued  launches  of  new  medicines • Q4  growth  5% Emerging  Markets  +17% • Increase  in  market  uptake  continues • Pulmicort +21% • Symbicort +10% US,  Europe  competitive Emerging  Markets  growth Symbicort global  leader  and Europe  volume  has  stabilised Q4  improved  sequentially $m Source:  QuintilesIMS Symbicort Pulmicort Others 0 200 400 600 800 1,000 1,200 1,400 Q4  2016 19% +8% -­13% 0 1,000 2,000 3,000 4,000 5,000 FY  2016 24% +8% -­10% -­5% -­3% Global  market  share  volume Europe  market  share  volume 30.5% 27.7% 25% 30% 35% Sep-­15 Oct-­15 Nov-­15 Dec-­15 Jan-­16 Feb-­16 Mar-­16 Apr-­16 May-­16 Jun-­16 Jul-­16 Aug-­16 Sep-­16 Oct-­16 Nov-­16 Symbicort Competitor 32.5% 25.4% 0% 20% 40% Sep-­15 Oct-­15 Nov-­15 Dec-­15 Jan-­16 Feb-­16 Mar-­16 Apr-­16 May-­16 Jun-­16 Jul-­16 Aug-­16 Sep-­16 Oct-­16 Nov-­16 Symbicort Competitor Absolute  values  at  actual  exchange  rates.  Growth  rates  at  CER  and  for  FY   unless  otherwise  stated
  • 15.
    First  Pearl  medicine available  in  the  US  for  COPD1 15 Respiratory:  Bevespi Aerosphere launched • Intelligent  formulation  for  a  pMDI  using  patented CO-­SUSPENSION™  Delivery  Technology2,3 • First  and  only  LAMA/LABA  in  the  familiar  pMDI  device2,4 • Maximise  bronchodilation5… achieved  a  381-­mL   improvement  in  peak  inspiratory  capacity6 1.  Bevespi is  indicated  for  the  long-­term,  maintenance  treatment  of  airflow  obstruction  in  patients  with  COPD,  including  chronic  bronchitis and/or  emphysema 2.,  3.,  4.,  6.  References  available  upon  request 5.  Improvements  in  lung  function  relative  to  its  individual  components  and  placebo  in  two  24-­week  pivotal  trials
  • 16.
    Global  growth  with focus  on  Farxiga 16 Diabetes US  +5% • Growing  market,  but  intense   competition  for  market  share • Farxiga +75%  from  improved   access  and  market-­share  gains Europe  +15% • Strong  growth  in  focus  medicine   Forxiga (+52%);;  and  Bydureon (+23%) • Forxiga leading  the  SGLT2  class Emerging  Markets  +25% • Strong  growth  in  Forxiga (+96%) Growth  in  all  regions Farxiga global  leader  in SGLT2  class  by  volume Farxiga largest  AstraZeneca Diabetes  medicine Source: QuintilesIMS $m Farxiga Onglyza Bydureon Byetta 0 100 200 300 400 500 600 700 Q4  2016 -­22% -­8% -­21% +57% 0 500 1,000 1,500 2,000 2,500 3,000 FY  2016 -­19% 0% -­6% +72% +3% +11% 41.8% 24.6% 24.5% 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% Sep-­15 Oct-­15 Nov-­15 Dec-­15 Jan-­16 Feb-­16 Mar-­16 Apr-­16 May-­16 Jun-­16 Jul-­16 Aug-­16 Sep-­16 Oct-­16 Nov-­16 Farxiga Competitor  1 Competitor  2 Absolute  values  at  actual  exchange  rates.  Growth  rates  at  CER  and  for  FY   unless  otherwise  stated
  • 17.
    Performance  reduced  by April  price  cuts;;  transformation  underway 17 Japan Tagrisso starting  to  change the  Japanese  business Solid  in-­market  performance improved  market-­share  rank Q4  Product  Sales  reduced  by   Crestor inventory  reductions Absolute  values  at  actual  exchange  rates.  Growth  rates  at  CER Long-­term  target  for  Japan: Low  single-­digit  growth $m Crestor Nexium Symbicort Others 0 100 200 300 400 500 600 700 Q4  2016 -­8% +27% +1% -­15% 0 500 1,000 1,500 2,000 2,500 FY  2016 -­5% +7% -­4% 0% -­5% -­3% #6 2016  AstraZeneca  position  in   Japan  market  company  rankings #12   2012  AstraZeneca  position  in   Japan  market  company  rankings 0 15 28 39 0 5 10 15 20 25 30 35 40 45 Q1  2016 Q2  2016 Q3  2016 Q4  2016 $m
  • 18.
    Solid  growth  continued 18 Brilinta US •Positive  momentum  from  changes  to   competitor’s  label • 60mg  ~10%  of  new  prescriptions Europe • Increase  in  hospital-­discharge  share   and  market-­share  gains • 60mg  launched  in  most  of  Europe Emerging  Markets • 147%  growth  in  China,  with  NRDL1 review  underway • Other  key  markets • Russia  +70% • Brazil  +17% Strong  execution  of lifecycle  management Growth  across all  markets Source:  QuintilesIMS Brilinta reached  peak  US new  prescription  share 1.  NRDL  =  National  Reimbursement  Drug  List $m US Europe EMs E.  RoW 0 50 100 150 200 250 Q4  2016 +62% +13% +50% 0 200 400 600 800 1,000 FY  2016 +37% +80% +15% +45% +39% 14.6% 6.9% 0% 2% 4% 6% 8% 10% 12% 14% 16% Brilinta Competitor  1 Absolute  values  at  actual  exchange  rates.  Growth  rates  at  CER  and  for  FY   unless  otherwise  stated
  • 19.
    Launches  progressing  well 19 New Oncology Tagrisso (lung  cancer) Tagrisso 2016 key  milestones Absolute  values  at  actual  exchange  rates Lynparza (ovarian  cancer) $m $m US Europe EMs E.  RoW US Europe EMs E.  RoW 0 20 40 60 80 100 120 140 160 Q1  2016 Q2  2016 Q3  2016 Q4  2016 0 50 100 150 200 250 FY  2015 FY  2016 $423m A  strong  first  year  for  Tagrisso 46 Number  of  countries  with  regulatory   approval 12,000 Number  of  patients  treated  with  Tagrisso
  • 20.
  • 21.
    FY  2016 $m %  change % Total   Revenue Q4  2016 $m %  change %  Total   Revenue Total  Revenue 23,002 (5) 100 5,585 (12) 100 -­ Product  Sales 21,319 (8) 93 5,260 (15) 94 -­ Externalisation  Revenue 1,683 59 7 325 77 6 Gross  Margin 80.8% 10bps -­ 78.0% (310)bps -­ R&D  Expenses 5,890 2 26 1,543 (5) 28 SG&A  Expenses 9,413 (12) 41 1,386 (44) 25 Other  Operating  Income 1,655 12 7 1,120 n/m 20 Tax  Rate 4% -­ -­ 17% -­ -­ EPS $2.77 9 $1.46 93 21 Reported  Profit  &  Loss Absolute  values  at  actual  exchange  rates.  Growth  rates  at  CER Gross  Margin  reflects  Gross  Profit  derived  from  Product  Sales,  divided  by  Product  Sales
  • 22.
    22 Reported  to  Core EPS  explanation Other  adjustments  include  provision  charges  related  to  certain  legal matters  and  fair  value  adjustments  arising  on  acquisition-­related  liabilities Reported  EPS  $2.77 $ FY  2016 Notes Adjustments Restructuring 0.69 Reductions  in  SG&A  reflecting progression  to New  AstraZeneca Intangibles 0.78 Acquisition of  MedImmune;;  Merck US  business  transaction,  others Diabetes  Alliance (0.17) Net  amount  of  intangible  amortisation  and adjustment  to  contingent  consideration Diabetes  Alliance contingent consideration expires in  2025 Other 0.24 Includes legal  provisions  and  discount   unwind  on  Acerta  Pharma  liability Core  EPS  $4.31
  • 23.
    FY  2016 $m %  change % Total   Revenue Q4  2016 $m %  change %  Total   Revenue Total  Revenue 23,002 (5) 100 5,585 (12) 100 -­ Product  Sales 21,319 (8) 93 5,260 (15) 94 -­ Externalisation  Revenue 1,683 59 7 325 77 6 Gross  Margin 82.0% (110)bps -­ 79.3% (260)bps -­ R&D  Expenses 5,631 5 24 1,481 2 27 SG&A  Expenses 8,169 (9) 36 2,050 (14) 37 Other  Operating  Income 1,717 14 7 1,142 n/m 20 Tax  Rate 11% -­ -­ 18% -­ -­ EPS $4.31 (5) $1.21 9 Product  Sales  decline;;  good  progress  on  cost  control 23 Core  Profit  &  Loss Absolute  values  at  actual  exchange  rates.  Growth  rates  at  CER Gross  Margin  reflects  Gross  Profit  derived  from  Product  Sales,  divided  by  Product  Sales
  • 24.
    24 Continued  progress  and focus  on  cost  discipline Material  reduction  in  Core  SG&A  delivered Stabilisation  in  Core  R&D  costs  now  realised • Growth  in  Core  costs • FY  up  by  5%  and  Q4  up  by  2% • Investment  focused  on  a  number  of  potential   medicines  in  pivotal  trials • Material  reduction  in  Core  costs • FY  down  by  9%  and  Q4  down  by  14% • A  base  reflecting  New  AstraZeneca • ~100  basis-­point  reduction  in  the  ratio  to Total  Revenue Absolute  values  and  growth  rates  at  CER 0 1 2 Q1  14 Q2  14 Q3  14 Q4  14 Q1  15 Q2  15 Q3  15 Q4  15 Q1  16 Q2  16 Q3  16 Q4  16 $bn 5%  yoy 0 1 2 3 Q1  14 Q2  14 Q3  14 Q4  14 Q1  15 Q2  15 Q3  15 Q4  15 Q1  16 Q2  16 Q3  16 Q4  16 $bn (9)%  yoy
  • 25.
    25 Core  R&D  investment stabilising • FY  2017  Core  R&D  costs  are  expected   to  be  at  a  similar  level  to  FY  2016 Absolute  values  at  actual  exchange  rates.  Growth  rates  at  CER 0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 2013 2014 2015 2016 Autoimmunity, neuroscience & infection Respiratory Cardiovascular & Metabolic Diseases Oncology 29% 37% 42% 43% 19% 23% 25% 28% 24% 28% 4% 29% 5% 12% 32% 20% Investment  weighted  towards  Oncology Sharper  focus  on  main  therapy  areas
  • 26.
    26 FY  2017  guidance and  capital-­allocation  priorities Guidance  at  CER Guidance Investment  in  the  business Progressive  dividend  policy Strong,  investment-­grade  credit  rating Immediately  earnings-­accretive,  value-­enhancing  opportunities Total   Revenue Low  to  mid  single-­ digit  percentage   decline Core  EPS Low  to  mid  teens   percentage   decline Capital-­allocation  priorities
  • 27.
  • 28.
    Main  therapy  areas 28 Q4 late-­stage  pipeline  highlights • Symbicort -­ asthma: Regulatory  approval  SMART1 (aged   12  to  <18  years) • benralizumab -­ severe,   uncontrolled  asthma:  Regulatory   submissions  (US,  EU) • Alzheimer’s  disease: Expanded  Lilly  alliance  with   MEDI1814  (Aβ42-­selective  mAb) Respiratory • Bydureon -­ type-­2  diabetes: Phase  III  DURATION-­7  trial   (Bydureon +  insulin  vs.  insulin)  met   primary  endpoint • roxadustat -­ anaemia: Initiated  rolling  regulatory   submission  (CN) Cardiovascular  & Metabolic  Diseases • durvalumab -­ bladder  cancer: -­Regulatory  submission  (US) -­Priority  Review  (US) • Tagrisso -­ lung  cancer  (AURA3   trial): -­Regulatory  submission  (US,  EU) -­Priority  Review  (US) • Faslodex -­ breast  cancer  (1L): Regulatory  submission  (US,  EU) • durva +  treme -­ head  &  neck   cancer:  Recruitment  restarted Oncology Other  -­ Neuroscience 1.  SMART  =  Symbicort Maintenance  And  Reliever  Therapy Status  since  the  prior  results  announcement  on  10  November  2016
  • 29.
    Progress  across  launched and  pipeline  medicines 29 Oncology  highlights  from  recent  meetings Tagrisso Phase  III  AURA3  trial:  2L  T790M   NSCLC Durvalumab Phase  II  ATLANTIC  trial:  3L+ metastatic  NSCLC Acalabrutinib Phase  I/II  trial:  Monotherapy  in   patients  intolerant  to  ibrutinib Acalabrutinib Phase  I/II  trial:  Monotherapy  in   patients  with  Richter’s  transformation Faslodex Phase  III  FALCON  trial:  1L  hormone-­ receptor  positive  advanced  breast   cancer
  • 30.
    First  randomised  Phase III  trial  to  demonstrate  superiority 30 Lung  cancer:  Tagrisso 1.  PFS  =  Progression-­Free  Survival 2.  Analysis  of  PFS  by  BICR  was  consistent  with  the  investigator-­based  analysis:  HR  0.28  (95%  CI  0.20;;  0.38),  p<0.001;;  median  PFS  11.0  vs.  4.2  months Source:  WCLC  2016,  abstract  PL03.03 AURA3  -­ 2L  T790M  NSCLC Investigator  assessment2 PFS1 HR  0.30  (95%  CI  0.23;;  0.41),  p<0.001;;  median  PFS  10.1  vs.  4.4   months PFS  by   investigator Tagrisso (N=279) Chemo   (N=140)   Median  PFS,   months  (95%   CI) 10.1 (8.3;;  12.3) 4.4   (4.2;;  5.6) HR  (95%  CI) 0.30  (0.23;;  0.41) p<0.001 Regulatory  submission  status US  ✔ EU  ✔ Priority  Review Tagrisso Platinum-­pemetrexed
  • 31.
    Comprehensive  programme  across the  disease 31 Lung  cancer:  IO  Phase  III  trials  overview ADJUVANT PACIFIC MYSTIC NEPTUNE PEARL  *NEW* ARCTIC Trial  design Stage  Ib-­IIIa Randomised,   controlled durvalumab  vs placebo Stage  III   unresectable Randomised,   controlled durvalumab  vs   placebo 1L EGFR/ALK  wt Non-­sq/sq Randomised,   controlled durvalumab, durva  +  treme  vs SoC 1L  EGFR/ALK  wt Non-­sq/sq Randomised,   controlled durva  +  treme  vs SoC 1L  EGFR/ALK  wt Non-­sq/sq PD-­L1 expressers Randomised,   controlled durvalumab  vs SoC 3L  EGFR/ALK  wt Non-­sq/sq PD-­L1  low Randomised,   controlled durvalumab,   tremelimumab,   durva  +  treme vs   SoC Primary   endpoint(s) DFS1 PFS OS2 PFS OS OS PFS OS PFS OS Data  readout 2020 H2  2017 Mid-­2017  (PFS) 2018  (final  OS) 2018 2020 H1  2017 Recruitment   status Ongoing Fully recruited Fully  recruited Ongoing Ongoing Fully  recruited First  line1.  DFS  =  Disease-­Free  Survival 2.  OS  =  Overall  Survival
  • 32.
    =  durvalumab =  durva +/-­ treme ✔ =  fully  recruited Bladder  cancer (UC1) DANUBE 1L Head  &  neck  cancer KESTREL 1L EAGLE 2L Lung  cancer (NSCLC) MYSTIC 1L  (final  OS) PEARL 1L (Asia) ARCTIC 3L  PD-­L1  neg. PACIFIC Stage  III  unresectable NEPTUNE 1L  (final  OS) ADJUVANT Adjuvant H1  2017 H2  2017 2018 2018+ Potential  leadership  in  IO &  IO-­IO  combinations  across  multiple  cancer  types Phase  III  news  flow;;  H1/mid-­2017  key 32 Durvalumab  and  durva  +  treme ✔ ✔ ✔MYSTIC 1L  (PFS) ✔ 1.  Urothelial  Carcinoma
  • 33.
    Unlocking  and  realising potential  of  new  medicine 33 Late-­stage  pipeline  news  flow  2017  &  2018 H1  2017  /  mid-­2017 H2  2017 2018 Regulatory  decision Faslodex -­ breast  cancer  (1L)  (JP) Tagrisso -­ lung  cancer  (AURA3)  (US) durvalumab -­ bladder  cancer  (US) saxa/dapa -­ type-­2  diabetes  (US) ZS-­9 -­ hyperkalaemia  (US,  EU) Faslodex -­ breast  cancer  (1L)  (US,  EU) Tagrisso -­ lung  cancer  (CN) Tagrisso -­ lung  cancer  (AURA3)  (EU) benralizumab -­ severe,  uncontrolled  asthma  (US) benralizumab -­ severe,  uncontrolled  asthma  (EU) Regulatory  submission Lynparza -­ ovarian  cancer  (2L) acalabrutinib -­ blood  cancer  (US)1 Bydureon -­ autoinjector  (US) Bevespi -­ COPD  (EU) benralizumab -­ severe,  uncontrolled  asthma  (JP) Lynparza -­ breast  cancer durvalumab -­ lung  cancer  (PACIFIC)  (US) durva  +/-­ treme -­ lung  cancer  (MYSTIC) -­ lung  cancer  (ARCTIC) Lynparza -­ ovarian cancer  (1L) Tagrisso -­ lung  cancer  (1L) durva  +/-­ treme -­ head  &  neck  cancer  (KESTREL) -­ head  &  neck  cancer  (EAGLE) -­ bladder  cancer  (DANUBE) moxetumomab -­ leukaemia selumetinib -­ thyroid  cancer Brilinta -­ T2D/CAD2 Bydureon -­ CVOT3 roxadustat -­ anaemia tralokinumab -­ severe,  uncontrolled  asthma Duaklir -­ COPD  (US) PT010 -­ COPD Key  Phase III/II*  data   readouts Lynparza -­ breast  cancer durva  +/-­ treme -­ lung  cancer  (MYSTIC)  (mid-­2017) -­ lung  cancer  (ARCTIC) acalabrutinib -­ blood  cancer*1 Lynparza -­ ovarian  cancer  (1L) Tagrisso -­ lung  cancer  (1L) durvalumab -­ lung  cancer  (PACIFIC) durva  +/-­ treme -­ head  &  neck  cancer  (KESTREL) moxetumomab -­ leukaemia tralokinumab -­ severe,  uncontrolled  asthma durva  +/-­ treme -­ lung  cancer  (NEPTUNE) -­ head  &  neck  cancer  (EAGLE) -­ bladder  cancer  (DANUBE) selumetinib -­ thyroid  cancer Brilinta -­ T2D/CAD Bydureon -­ CVOT roxadustat -­ anaemia4 PT010 -­ COPD anifrolumab -­ lupus 1.  Potential  fast-­to-­market  opportunity  ahead  of  randomised,  controlled  trials 2.  T2D/CAD  =  Type-­2  diabetes/Coronary  Artery  Disease 3.  CVOT  =  Cardio-­Vascular  Outcomes  Trial 4.  AstraZeneca-­sponsored  trials
  • 34.
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    • Financials  on track;;  met  guidance  for  the  year • 12  new  potential  medicines  in  Phase  III/under  registration • Oncology  progressing  ahead  of  expectations – Tagrisso – Immuno-­Oncology • Busy  news  flow  over  next  6-­12  months New  AstraZeneca  emerging  from  patent  cliff 35 Pipeline-­driven  transformation  on  track
  • 36.
  • 37.
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