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TRANSCRIPT
Q1 2016 Results
29 April 2016
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
3
Agenda
Overview Pascal Soriot
Growth Platforms Luke Miels
Finance Marc Dunoyer
Pipeline Sean Bohen
Closing Pascal Soriot
• 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
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)
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)
Luke MielsEVP, Global Product & Portfolio Strategy, Global Medical Affairs and Corporate Affairs
Growth Platforms
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
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
10
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
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
• 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
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
• 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
Marc DunoyerChief Financial Officer
Finance
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 $0.95, -7%• Adverse currency impact 5%
1. As a percentage of Total RevenueAbsolute values at actual exchange rates. Growth rates and guidance at CER
Q1 2016$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
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
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
20
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
21
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
Sean BohenEVP, Global Medicines Development & Chief Medical Officer
Pipeline
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
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)
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)
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
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
Pascal SoriotChief Executive Officer
Closing
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
Q1 2016 Results
29 April 2016