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Q1 2016 Results 29 April 2016

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Page 1: Q1#2016#Results - AstraZeneca€¦ · • Established#portfolio#benefitsfrom#better#diagnosis,# accessand#patient#demographics/trends • Balanced#presence:#~Half#in#China,#Brazil#+19%,#

Q1 2016 Results

29 April 2016

Page 2: Q1#2016#Results - AstraZeneca€¦ · • Established#portfolio#benefitsfrom#better#diagnosis,# accessand#patient#demographics/trends • Balanced#presence:#~Half#in#China,#Brazil#+19%,#

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 cautionarystatement:

This document contains certain forward-­looking statements with respect to the operations, performance and financial condition of the Group, including, among otherthings, statements about expected revenues, margins, earnings per share or other financial or other measures. Although we believe our expectations are based onreasonable assumptions, any forward-­looking statements, by their very nature, involve risks and uncertainties and may be influenced by factors that could causeactual outcomes and results to be materially different from those predicted. The forward-­looking statements reflect knowledge and information available at the date ofpreparation of this document and AstraZeneca undertakes no obligation to update these forward-­looking statements. We identify the forward-­looking statements byusing the words 'anticipates', 'believes', 'expects', 'intends' and similar expressions in such statements. Important factors that could cause actual results to differmaterially from those contained in forward-­looking statements, certain of which are beyond our control, include, among other things: the loss or expiration of, orlimitations to, patents, marketing exclusivity or trademarks, or the risk of failure to obtain and enforce patent protection;; the risk of substantial adverselitigation/government investigation claims and insufficient insurance coverage;; effects of patent litigation in respect of IP rights;; exchange rate fluctuations;; the risk thatR&D will not yield new products that achieve commercial success;; the risk that strategic alliances and acquisitions, including licensing and collaborations, will beunsuccessful;; the impact of competition, price controls and price reductions;; taxation risks;; the risk of substantial product liability claims;; the impact of any delays in themanufacturing, 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 forproducts;; 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 anadverse impact of a sustained economic downturn;; political and socio-­economic conditions;; the risk of environmental liabilities;; the risk of occupational health andsafety liabilities;; the risk associated with pensions liabilities;; the risk of misuse of social medial platforms and new technology;; the risks associated with developing ourbusiness in emerging markets;; the risk of illegal trade in our products;; the risks from pressures resulting from generic competition;; the risk of failure to successfullyimplement planned cost reduction measures through productivity initiatives and restructuring programmes;; economic, regulatory and political pressures to limit orreduce the cost of our products;; the risk that regulatory approval processes for biosimilars could have an adverse effect on future commercial prospects;; the impact offailing to attract and retain key personnel and to successfully engage with our employees;; the impact of increasing implementation and enforcement of more stringentanti-­bribery and anti-­corruption legislation;; and the risk of failure of information technology and cybercrime. Nothing in this presentation / webcast should be construedas a profit forecast.

2

Forward-­looking statements

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3

Agenda

Overview Pascal Soriot

Growth Platforms Luke Miels

Finance Marc Dunoyer

Pipeline Sean Bohen

Closing Pascal Soriot

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• Continued delivery–Total Revenue +5%;; Growth Platforms +6%–Core SG&A cost decline, slower Core R&D cost growth despite M&A–Four regulatory approvals, four regulatory designations

• Advancing the strategy–Sharpening focus on main therapy areas:Oncology, Respiratory, Cardiovascular & Metabolic Disease–Driving productivity improvements: $1.1bn annual savings from end 2017

4

Q1 2016: Good start to the year;; advancing the strategy

Absolute values at Constant Exchange Rates (CER). Growth rates at CER unless otherwise stated

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5

Q1 2016: Total Revenue up 5%;; SG&A down 6%

Absolute values at actual exchange rates. Growth rates at CER

$m % change

%Total Revenue

%currencyimpact

Total Revenue 6,115 +5 100 (4)

Core R&D 1,429 +15 23 (3)

Core SG&A 2,127 (6) 35 (4)

Core EPS ($) 0.95 (7) -­ (5)

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Four approvals;; four designations

6

Q1 2016: Pipeline headlines

Potential regulatorysubmissions of new medicines

durva + treme(lung, head & neck, pancreatic cancers)

acalabrutinib(blood cancer)

durvalumab(lung, head & neck cancer)

roxadustat(anaemia) (CN)

moxetumomab(leukaemia)

benralizumab(severe asthma)

selumetinib(lung cancer)

2016 2017

Status since the prior results announcement on 4 February 2016

• Regulatory approvals

• Bevespi Aerosphere (PT003) -­ COPD (US)

• Zurampic -­ gout (EU)

• Brilique -­ post-­MI (EU)

• Tagrisso -­ lung cancer (JP)

• Regulatory designations

• Breakthrough Therapy:

durvalumab -­ bladder cancer (US)

• Orphan Drug: acalabrutinib -­ blood cancers (EU) MEDI-­551 -­ neuromyelitis optica (US)

• Fast Track: MEDI8852 -­ hospitalised influenza A (US)

Page 7: Q1#2016#Results - AstraZeneca€¦ · • Established#portfolio#benefitsfrom#better#diagnosis,# accessand#patient#demographics/trends • Balanced#presence:#~Half#in#China,#Brazil#+19%,#

Luke MielsEVP, Global Product & Portfolio Strategy, Global Medical Affairs and Corporate Affairs

Growth Platforms

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Q1 2016$m

%change

% TotalRevenue

Growth Platforms 3,435 +6 56

Respiratory 1,207 +2 -­

Brilinta/Brilique 181 +46 -­

Diabetes 578 +23 -­

Emerging Markets 1,465 +6 -­

Japan 429 (7) -­

New Oncology 99 n/m -­

8

Growth Platforms: Resilient performance despite challenging conditions

Absolute values at actual exchange rates. Growth rates at CER

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9

Respiratory: Strength in Emerging Markets

US +4%• Symbicort volume growth partly offset by managed care implementation

EU (14)%• Lower market growth;; increased competitive pressure from analogues

Emerging Markets +20%• China uptake continues;; +34%, in particular Pulmicort;; +24% in overall EM

Continued strength in Emerging MarketsEvolution of Respiratory portfolioGrowth supported

by new medicines

Absolute values at actual exchange rates. Growth rates at CER

Q1 20160

500

1,000

+38%

+14%

(7)%

+2%

Symbicort Pulmicort Other

$m

Established medicines

Combination medicines

Biologic medicines

PT010benralizumab

tralokinumab

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Brilinta/Brilique: Continued momentum in all markets

US• New ACC and AHA guidelines: Brilinta preferred over clopidogrel in ACS

EU• Approval for post-­MI indication• Indication leadership across EU markets

Emerging Markets• China strongest growth (+229%);; improved/innovative market access

Global execution oflifecycle management

US oral anti-­platelet class market share total prescriptions

Consistent highgrowth across markets

Absolute values at actual exchange rates. Growth rates at CER Source: IMS Health NPA, weekly data through w/e1 April 2016

Q1 20160

50

100

150

200

+19%

+52%

+109%

+46%

+22%

$m

USEurope

Emerging MarketsEst. ROW

90.8%

90%91%92%93%94%

4.4%

4.8%

0%

2%

4%

6%

1/03/14

2/07/14

3/14/14

4/18/14

5/23/14

6/27/14

8/01/14

9/05/14

10/10/14

11/14/14

12/19/14

1/23/15

2/27/15

4/03/15

5/08/15

6/12/15

7/17/15

8/21/15

9/25/15

10/30/15

12/04/15

1/08/16

2/12/16

3/18/16

BRILINTA Competitor 1Competitor 2

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11

Diabetes: Global franchise growth continues

US +14%• Farxiga benefit from access and increased focus

EU +18%• Growth from Farxiga and Bydureon from increasing Diabetes footprint

Emerging Markets +65%• Continued Forxiga launch, Onglyza uptake

Strong growth in all marketsAbsolute Q1 2016 growth of Diabetes franchise by geography

Quarterly growthcontinues at >20%

14

17

31

Est. RoW

EU

EM

US

Absolute values at actual exchange rates. Growth rates at CER Absolute values at CER in bar chart above

Q1 20160

200

400

600

(30)%

+128%

+20%

+11%

$m+23%

47

$m

OnglyzaFa(o)rxiga

BydureonByetta

Other

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• Established portfolio benefits from better diagnosis,

access and patient demographics/trends

• Balanced presence: ~Half in China, Brazil +19%,

Russia +5%

• Challenging conditions in some Latin-­American and

Middle-­Eastern markets

• New medicines and pipeline well-­positioned for growing

patient needs, e.g. Tagrisso in Asia

12

Emerging Markets: Growth in line with long-­term ambitions

Broad-­based performanceOn track with long-­term goals

FY 2012 FY 2013 FY 2014 FY 2015 Q1 2016

Emerging Markets

Growth rates at CER

FY 2012 FY 2013 FY 2014 FY 2015 Q1 2016

China

+4%

+8%

+12% +12%

+15%+22%

+19%+17%

+6%

+11%

Long-­term target: Mid-­to-­high single-­digit growth

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13

Japan: Performance reflects April price cuts

• Maintaining strong market

share despite challenging

external environment

• Tagrisso regulatory approval;;

higher prevalence of EGFR

mutation

Established products to be augmented by new opportunities Leading dynamic patient shareGrowth supported

by new products

Absolute values at actual exchange rates. Growth rates at CER Source: IMS, February 2016

Q1 20160

200

400

(6)%

(24)%

+2%

(2)%

(7)%

CrestorNexium

SymbicortOther

$m

38%

30%35%

25%21% 21%22%

17% 15%

Symbicort Nexium Crestor

AZ Competitor 1 Competitor 2Long-­term target:

Low single-­digit growth

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• US: Steady growth in testing rates

• EU: Half of eligible patients know BRCAm status

US: 4th line+ patientsEU4 (France, Germany, Italy & Spain): 2nd line platinum-­sensitive recurrent patients

0%20%40%60%80%

Q3 14 Q1 16 Q4 14 Q1 16

BRCA testing rates

US 4L+ EU4 2L PSR

14

New Oncology Launches progressing well

Tagrisso(lung cancer)

Steady increase in ovarian cancer patients with known BRCA status

Lynparza(ovarian cancer)

Absolute values at actual exchange rates

Source: IPSOS Oncology monitor

• Global Product Sales $44m

• Launched in 21 countries;; regulatory reviews ongoing in 14

0

20

40

Q1 2015 Q2 2015 Q3 2015 Q4 2015 Q1 2016

Global Product Sales

US EU Intl

$m

• Global Product Sales $51m• Testing rates growing rapidly in markets where launched

• FDA approval of ctDNAtest expected Q2 2016

0

1,000

2,000

3,000

4,000

5,000

Nov-­15 Dec-­15 Jan-­16 Feb-­16 Mar-­16

US cumulative unit demand volume

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Marc DunoyerChief Financial Officer

Finance

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16

Q1 2016: Financial headlines

Celgene PD-­L1

BACE-­inhibitor

Total Revenue $6.1bn, +5%• Adverse currency impact 4%

• Growth Platforms 56% of total1, +6%

• Externalisation Revenue $550m, +78%

Core SG&A costs reduced

• 6% decline to $2.1bn

• 35% of Total Revenue, a 420 basis-­point

reduction from Q1 2015

Increased financing costs• Acquisition of ZS Pharma

• Investment in Acerta Pharma

Other Operating Income reduction, -­81%

Core EPS $0.95, -­7%• Adverse currency impact 5%

1. As a percentage of Total RevenueAbsolute values at actual exchange rates. Growth rates and guidance at CER

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Q1 2016$m

%change

% TotalRevenue

Total Revenue 6,115 +5 100

Product Sales 5,565 +1 91

Externalisation Revenue 550 +78 9

Core Cost of Sales (966) +6 16

Core Gross Profit 5,149 +5 831

Core R&D (1,429) +15 23

Core SG&A (2,127) (6) 35

Core Tax Rate 17% -­ -­

Core EPS $0.95 (7)

Top-­line strength combined with Core SG&A cost discipline

17

Profit & Loss

1. Gross Profit as % of Total Revenue reflects Gross Profit derived from Product Sales, divided by Product Sales.Absolute values at actual exchange rates. Growth rates at CER

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Core SG&A cost reduction delivered

18

Continued progress and focus on cost discipline

Absolute values at constant exchange rates. SM&M = Sales, Medical & Marketing. G&A = General & Administration

0.0

0.5

1.0

1.5

2.0

2.5

Q1 2015 Q2 2015 Q3 2015 Q4 2015 Q1 2016

$bn

SM&M

G&A

Decline in Core R&D costs from Q4 2015

0.0

0.5

1.0

1.5

2.0

Q1 2015 Q2 2015 Q3 2015 Q4 2015 Q1 2016

$bn

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19

Advancing strategy: Sharpening focus, enhancing operational effectiveness, adjusting the cost structure

Celgene PD-­L1

BACE-­inhibitor

ACTIONS1. Sharpening focus on main therapy areas;;

prioritise investment;; increase for Oncology2. Reduce Core SG&A costs

-­ Global, regional and country levels

-­ Greater use of shared services

3. Reshapemanufacturing-­ Streamline costs;; implement biologics

capacity build

4. Continue overall productivityand simplificationefforts across business & R&D

FINANCIAL IMPLICATIONS

-­ Once implemented end 2017 annual benefit of ~$1.1bn versus FY 2015, primarily in Core SG&A

-­ Mitigating the growth of Core R&D costs from an

accelerating pipeline

-­ Restructuring charges of ~$1.5bn, virtually all cash

2016 guidance unchanged

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A year of challenges and opportunities

$4.26Core EPS

FY 2015

Growth Platforms

Potential approvals

Increasing Externalisation Revenue and Other Operating

Incomes

Crestor Dilution Currency

EMBEDDED IN GUIDANCE

Cost discipline

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FY 2016 guidance & capital-­allocation priorities

Total Revenue Low to mid single-­digit percentage decline

Core EPS Low to mid single-­digit percentage decline

Growth rates and guidance at CER

Capital-­allocation priorities

Investment in the business

Progressive dividend policy

Strong, investment-­grade credit rating

Earnings-­accretiveopportunities

FY 2016 guidance

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Sean BohenEVP, Global Medicines Development & Chief Medical Officer

Pipeline

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Recognition of pipeline quality and progress continued

23

Key regulatory designations received in the period1

• Breakthrough Therapy: durvalumab -­ bladder cancer (US)

• Orphan Drug:

– Acalabrutinib (chronic lymphocytic leukaemia (CLL) / small lymphocytic lymphoma (SLL);; mantle cell lymphoma (MCL);; lymphoplasmacytic lymphoma (Waldenström’smacroglobulinaemia, WM) (EU)

– MEDI-­551 -­ neuromyelitis optica (US)

• Fast Track: MEDI8852 -­ hospitalised influenza A (US)

1. Status since the prior results announcement on 4 February 2016

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24

Q1 late-­stage pipeline headlines

• Tagrisso -­ lung cancer:-­Approval (JP)-­CAURAL trial will not re-­start-­FLAURA 1st-­line trial fully recruited-­encouraging 1st-­line data at ELCC

• tremelimumab -­ mesothelioma: DETERMINE trial did not meet primary endpoint

• durva + treme trial started: Phase II unresectable liver cancer

Oncology

• Brilique-­ post-­MI: Approval (EU)-­ stroke: SOCRATES missed primary endpoint

• AZD3293 -­ Alzheimer’s disease: Phase II safety interim met;; un-­gating Phase III programme

Cardiovascular & Metabolic Disease (CVMD)

• Symbicort -­ COPD: Approval pressurised metered-­dose inhaler (pMDI) (EU)

• Bevespi -­ COPD: Approval (US)

• Zurampic -­ gout: Approval (EU)

Respiratory, Inflammation & Autoimmunity (RIA)

Status since the prior results announcement on 4 February 2016

Infection, Neuroscience & Gastrointestinal (ING)

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Encouraging first-­line activity continues

25

Tagrisso Phase I efficacy updates

Source: Presentation at European Lung Cancer Conference 2016

Response rate: 77% confirmed ORR(95% CI 64-­87%, 80/160mg dose combined, by investigator)

Progression-­free survival: 19.3 months(95% CI 13.7-­NC, 80/160mg dose combined, by investigator)

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Durvalumab’s rapid progress in blood cancer

26

Celgene IO collaboration: One year on

Trial Disease Design Protocolcomplete Trial initiation

Phase I Multiple myeloma(relapsed/refractory)

durvalumab +/-­ pomalidomide +/-­dexamethasone

Phase I Multiple myeloma(newly diagnosed)

durvalumab + revlimid +/-­dexamethasone Mid 2016

Phase I/II Non-­Hodgkin’s lymphoma/chronic lymphocytic leukemia

durvalumab +/-­ lenalidomide + rituximab or ibrutinib or rituximab + bendamustine

Mid 2016

Phase I/II Non-­Hodgkin’s lymphoma(untreated high-­risk DLBCL)

durvalumab + rituximab-­CHOPchemotherapy ordurvalumab + revlimid + rituximab-­CHOP chemotherapy

H2 2016

Phase I/II Myelodysplastic syndrome/acute myeloid leukaemia (high risk) azacitidine +/-­ durvalumab Mid 2016

Phase II Myelodysplastic syndrome(azacitidine injection failures) CC-­486 +/-­ durvalumab Mid 2016

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Realising potential of new medicines

27

Pipeline newsflow in 2016-­2017

Q2 2016 H2 2016 H1 2017Regulatory decisions ZS-­9 -­ hyperkalaemia (US) saxa/dapa -­ type-­2 diabetes (EU)

cediranib -­ ovarian cancer (EU)CAZ AVI -­ serious infections (EU)

brodalumab -­ psoriasis (US, EU)ZS-­9 -­ hyperkalaemia (EU)

Regulatory submissions saxa/dapa -­ type-­2 diabetes (US) Bevespi Aerosphere -­ COPD (EU)benralizumab -­ severe asthma(US, EU)

roxadustat -­ anaemia (CN)acalabrutinib -­ blood cancer (US)

Brilinta/Brilique -­ PAD

Lynparza -­ gastric, breast, ovarian (2nd line) cancersselumetinib -­ lung cancerdurvalumab -­ H&N cancer (HAWK)

Key data readouts benralizumab -­ severe asthma

Lynparza -­ gastric cancer

Brilinta/Brilique -­ PAD1Lynparza -­ breast, ovarian (2nd line) cancersselumetinib -­ lung cancerdurvalumab -­ H&N cancer (HAWK)acalabrutinib -­ blood cancer

Lynparza -­ ovarian cancer (1st line)durvalumab -­ lung cancer (PACIFIC)durva + treme-­ lung cancer (MYSTIC, ARCTIC)-­ head and neck cancer (CONDOR)

1. PAD = Peripheral Arterial Disease

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Pascal SoriotChief Executive Officer

Closing

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29

Q1 2016: Good start to the year;; advancing the strategy

Absolute values at CER. Growth rates at CER unless otherwise stated

• Continued delivery–Total Revenue +5%;; Growth Platforms +6%–Core SG&A cost decline, slower Core R&D cost growth despite M&A–Four regulatory approvals, four regulatory designations

• Advancing the strategy–Sharpening focus on main therapy areas:Oncology, Respiratory, Cardiovascular & Metabolic Disease–Driving productivity improvements: $1.1bn annual savings from end 2017

Page 30: Q1#2016#Results - AstraZeneca€¦ · • Established#portfolio#benefitsfrom#better#diagnosis,# accessand#patient#demographics/trends • Balanced#presence:#~Half#in#China,#Brazil#+19%,#

Q1 2016 Results

29 April 2016