Full Year Results - astrazeneca.com · The forward-looking statements reflect knowledge and...
Transcript of Full Year Results - astrazeneca.com · The forward-looking statements reflect knowledge and...
1
AstraZeneca 2013 Full Year Results
2
Cautionary statement regarding forward-looking statements In order, among other things, to utilise the 'safe harbour' provisions of the US Private Securities Litigation Reform Act 1995, we are providing the following
cautionary statement: This presentation contains certain forward-looking statements with respect to the operations, performance and financial condition of
the Group. 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 presentation 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 patents, marketing exclusivity or trade
marks, or the risk of failure to obtain patent protection; the risk of substantial adverse litigation/government investigation claims and insufficient insurance
coverage; exchange rate fluctuations; the risk that R&D will not yield new products that achieve commercial success; the risk that strategic alliances and
acquisitions 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 failure by third parties to supply materials or services; the risk of failure to manage a crisis; the risk of delay to new product launches; the
difficulties of obtaining and maintaining regulatory approvals for products; the risk of failure to observe ongoing regulatory oversight; the risk that new
products do not perform as we expect; the risk of environmental liabilities; the risks associated with conducting business in emerging markets; the risk of
reputational damage; the risk of product counterfeiting; the risk of failure to successfully implement planned cost reduction measures through productivity
initiatives and restructuring programmes; the risk that regulatory approval processes for biosimilars could have an adverse effect on future commercial
prospects; and the impact of increasing implementation and enforcement of more stringent anti-bribery and anti-corruption legislation.
Nothing in this presentation should be construed as a profit forecast.
3
Agenda
Pascal Soriot 2013: Gaining momentum
Marc Dunoyer 2013 financial performance and 2014 guidance
Briggs Morrison Pipeline review
Pascal Soriot Closing remarks
2013: Gaining momentum
Pascal Soriot
Chief Executive Officer, AstraZeneca
5
2013 2014 2015 2016 2017 2018 2019 2020 Beyond 2020
Return to growth Rebuild the
pipeline
Acknowledged leaders in our core TAs
2013 was an important step on our journey
6
Revenue $25,711m -6% (CER)
Core EPS $5.05 -23% (CER)
Dividend per share $2.80
2013 financial results in line with our expectations
7
2013 global revenues in line with our expectations
US 9,691 -9%
Europe 6,658 -9%
Emerging Markets 5,389 +8%
Japan 2,485 +4%
Other established ROW 1,488 -29%
2013
$m
CER
growth
Global Revenue 25,711 -6%
8
Good progress in 2013 across our strategic priorities
Achieve
scientific
leadership
1 Return
to growth
2 Be a great
place to work
3
9
Achieve
scientific
leadership
Late stage pipeline almost doubled and core TAs strengthened
6 additions to late stage pipeline
• Oncology: Olaparib, selumetinib, moxetumomab
• RIA: Benralizumab, PT003
• CVMD: Epanova
Strengthened oncology and other core TAs
• Immunocore, Spirogen, Amplimmune, Fibrogen, Pearl,
Moderna, BMS Diabetes Acquisition
R&D model transformation accelerated
• UK and US changes accelerated, biotech model implemented
Achieve
scientific
leadership
1
Achieve
scientific
leadership
1
10
Good progress in 2013 across our strategic priorities
Achieve
scientific
leadership
Be a great
place to work
Return
to growth
1 2 3
11
Brilinta 283 216
Diabetes 787 75
Respiratory 4,677 7
Emerging Markets 5,389 8
Japan 2,485 4
Growth drivers 12,471 10
2013
$m
CER
growth %
Growth platform revenues up 10% to $12.5bn Return
to growth
2
12
Brilinta: Good progress Europe, International
• 2013 Brilinta revenues up 216%
to $283m
• Leadership position achieved in some
European markets
• Making progress but more work needed in
the US
FY 12
$m
0
50
100
150
200
250
300
FY 13
Note: Growth rates all CER
US $73m
EUR $163m
EST ROW $17m
EM $30m
Return
to growth
2
13
0.8%
1.8%
0.0%
1.0%
2.0%
3.0%
4.0%
5.0%
6.0%
7.0%
8.0%
Aug-11 Oct-11 Dec-11 Feb-12 Apr-12 Jun-12 Aug-12 Oct-12 Dec-12 Feb-13 Apr-13 Jun-13 Aug-13 Oct-13 Dec-13
TRx Share NBRx Share
Return
to growth
2Brilinta: US performance
Source: IMS Health. Copyright 2014. All rights reserved. NPA. Monthly data through December, 2013
OAP Volume
Source: IMS Health. Copyright 2014. All rights reserved. MIDAS; Kantar Health Epi Database; Millennium Research Group; AstraZeneca Global Forecasting Analysis. Note: OAP volume is based on days of therapy. Note: This slide is necessarily forward looking and includes areas for which additional studies may be explored for the purpose of seeking additional indications or expanded labelling
Brilinta: Investing to realise significant potential
• Today: Investments made in Brilinta
promotion, access, affordability,
scientific leadership
• 2014: Commercial focus sharpened across
US, EU and International geographies
• 2016: Significant value creation potential
through LCM programs in post-MI
(PEGASUS), acute stroke (SOCRATES)
& PAD (EUCLID)
% Clinical trial
SOCRATES
EUCLID
PEGASUS
PLATO
Large untapped volume with active
clinical trials to access opportunity
20% ACS
27% Post-ACS
16% Elective Stent
14% PAD
23% Stroke
Return
to growth
2
0
10
20
30
40
50
60
70
80
90
100
20% ACS
27% Post-ACS
16% Elective Stent
14% PAD
23% Stroke
15
Diabetes: building the franchise
• Revenues growing to $787m
• Diabetes acquisition closed 1 February
• Onglyza stable
• Exenatide share growing
• Farxiga US launch 7 February
0
100
200
300
400
500
600
700
800
$m
FY 12 FY 13
Note: Growth rates all CER
Return
to growth
2
Bydureon $151m
Symlin $42m
Onglyza $378m
Forxiga $10m
Byetta $206m
16
17.5%
24.6%
0%
5%
10%
15%
20%
25%
30%
35%
40%
Jul-12 Aug-12 Sep-12 Oct-12 Nov-12 Dec-12 Jan-13 Feb-13 Mar-13 Apr-13 May-13 Jun-13 Jul-13 Aug-13 Sep-13 Oct-13 Nov-13 Dec-13
Bydure
on G
LP
-1 S
hare
TRx Share NBRx Share Exit
Share
Gains
Q1 Q2 Q3 Q4 FY
TRx +2.0 +0.8 +0.8 +0.9 +4.5
NBRx -0.9 -2.1 +1.9 +0.9 -0.2
Return
to growth
2
Source: IMS Health. Copyright 2014. All rights reserved. NPA (December’13 Actuals)
Diabetes: BYDUREON gaining TRx & NBRx share in US
17
Respiratory: Symbicort up 10%
0
500
1,000
1,500
2,000
2,500
3,000
3,500
$m
FY 12 FY 13
Return
to growth
2
• 2013 Symbicort revenues up 10%
to $3,483m
• Symbicort NBRx market share was up
7 points in US
• Share growth in Japan, China and many
International markets
Note: Growth rates all CER
EUR $1,502m +1%
US $1,233m +23%
EST ROW $423m +7%
EM $325m +17%
18
Respiratory: US SYMBICORT Net Sales +23%
Source: IMS Health. Copyright 2014. All rights reserved. NPA (December’13 Actuals)
Return
to growth
2
35.3%
26.2%
18%
20%
22%
24%
26%
28%
30%
32%
34%
36%
Jan-12 Mar-12 May-12 Jul-12 Sep-12 Nov-12 Jan-13 Mar-13 May-13 Jul-13 Sep-13 Nov-13
NBRx TRx Share
2012 Share Growth 2013 Share Growth
+6.81
+3.85
+2.08
+1.53
19
Emerging Markets: Up 8%, driven by China AZ significantly outgrows MNC and total market in China
Growth Rate by Month in China Hospital Market Growth%
YTD Growth Rate 19.5% 14.2% 13.5%
0.0%
5.0%
10.0%
15.0%
20.0%
25.0%
30.0%
35.0%
40.0%
AZ MNC Total China
Source: IMS Health. Copyright 2014. All rights reserved. 13M11data; BISO analysis
Return
to growth
2
Jan-13 Feb-13 Mar-13 Apr-13 May-13 Jun-13 Jul-13 Aug-13 Sep-13 Oct-13 Nov-13
Japan: strong in-market growth
2010 2011 2012 2013
Good performance Growth in brand volume market share
(points)
+4.3 pts
+2.8 pts
+11.5 pts
Dec
Source: IMS Health. Copyright 2014. All rights reserved. Points show 2013 vs. 2012
Return
to growth
2
• AZKK up from 12th to 9th in ranking
• Growth +4% CER
• In-market growth +11%
Source: IMS Health. Copyright 2014. All rights reserved.
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AstraZeneca 2013 Full Year Results
Marc Dunoyer,
Chief Financial Officer
2013 financial performance and 2014 guidance
23
Headline results 2013
Revenue 6,844 7,282 -4% 25,711 27,973 -6%
Core Operating Profit 1,983 2,795 -26% 8,390 11,159 -22%
Core EPS $1.23 $1.71 -25% $5.05 $6.83 -23%
Q4
2013 FY
2013 FY
2012
Q4
2012 CER CER
24
Core margin FY 2013
Revenue 25,711 -6%
$m
CER
growth
Delta vs
PY CER
%
sales
Core Gross Margin 21,078 -7% 82.0 -50bps
Distribution (306) -3% 1.2 0bps
Core R&D (4,269) +1% 16.6 -110bps
Core SG&A (8,865) +7% 34.5 -430bps
Core Other Income 752 -30% 2.9 -100bps
Core Operating Profit 8,390 -22% 32.6 -690bps
25
Restructuring update
March 2013 Additional activities Feb 2014
COSTS $2.3bn +$0.9bn $3.2bn
CASH $1.7bn +$0.7bn $2.4bn
ANNUAL BENEFITS
ON COMPLETION
(2016)
$0.8bn +$0.3bn $1.1bn
HEADCOUNT
(Gross FTEs) (5,050) (550) (5,600)
26
Net cash from operating activities 7,400 6,948
2013 $m
2012 $m
EBITDA 8,295 10,666
Movement in working capital 166 (706)
Tax & interest paid (1,319) (2,588)
Other non-cash movements 258 (424)
Cash generation: FY 2013
27
Net cash flow after distributions 1,464
2013 $m
Net cash from operating activities 7,400
Net capex (673)
Dividends/share issues (2,979)
Acquisitions and business development (2,273)
Other movements (11)
Cash application: FY 2013
28
Business development aligned with priority TAs
CV/Metabolism Respiratory/Inflammation/ Autoimmune
Oncology Early Stage
Late Stage
NGM
Epanova Hypertriglyceridemia
enteroendocrine cells Diabetes/Obesity mRNA mRNA
AccurinTM nanomedicine
3 preclinical projects
Triple combination LABA/LAMA/ICS
Pearl Triple combination
LABA/LAMA/ICS LABA/LAMA COPD
ACP-501 Reverse cholesterol
transport RDX5791 End stage renal disease
& chronic kidney disease
FG-4592 End stage renal disease &
chronic kidney disease
AMP-514
MK-1775 (WEE1) Antibody-drug
conjugates
Abiraterone acetate Diabetes
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Cash distributions
• FY 2013 dividend $2.80 per share
• FY 2013: No share repurchases
• FY 2014: No repurchases planned currently
Dividend
Share
repurchases
30
Guidance
Low-to-mid single digit decline 2014 Revenue (CER)
Percentage decline in the teens 2014 Core EPS (CER)
Progressive dividend policy reconfirmed Dividend
Above guidance assumes US Nexium generic end of May 2014
Broadly in line with 2013 2017 Revenue (CER)
31
AstraZeneca 2013 Full Year Results
32
Briggs Morrison, Executive Vice President
Global Medicines Development
Pipeline review
33
Significant phase III & pipeline progression
Exciting assets underpinning scientific leadership
Pipeline review
2013
2014
34
We anticipated 5-7 NME Phase 3 starts 2013-2014
2013 2014
benralizumab
asthma
AZD6765
depression
ATM AVI
serious infections
olaparib
solid tumours
sifalimumab/MEDI-546
systemic lupus erythematosus
AZD4547
gastric cancer
moxetumomab pasudotox
hairy cell leukaemia
mavrilimumab
rheumatoid arthritis
AZD5069
asthma
selumetinib
non-small cell lung cancer
MEDI-551
haematological malignancies
tralokinumab
asthma
Terminated 2015
35
Continuous news flow in 2013 as anticipated Product Milestone
NME
fostamatinib – rheumatoid arthritis Phase III data
naloxegol – opioid-induced constipation Phase III data (KODIAC-08)
moxetumomab pasudotox – hairy cell leukaemia Potential phase III start
olaparib – solid tumours Potential phase III start
CXL – methicillin-resistant Staphylococcus aureus Potential phase III start
benralizumab – asthma Potential phase III start
selumetinib – non-small cell lung cancer Potential phase III start
naloxegol – opioid-induced constipation Submission for approval in USA & Europe
fostamatinib – rheumatoid arthritis Submission for approval in USA & Europe
OTHER
Forxiga – type 2 diabetes (triple therapy) Submission for approval in Europe
Brilinta – acute coronary syndrome Submission for approval in Japan
Forxiga – type 2 diabetes Submission for approval in Japan & China
Zoladex – three month depot (breast cancer) Submission for approval in Japan
Onglyza SAVOR-TIMI53 – outcomes study Study results
brodalumab – psoriatic arthritis Potential phase III start
Forxiga – type 2 diabetes Resubmission for approval in USA
Onglyza SAVOR-TIMI53 – outcomes study Submission for approval in USA &Europe
Bydureon Dual Chamber Pen – type 2 diabetes Submission for approval in USA
FluMist Quadrivalent – flu vaccine Launch in US
Casodex oral dispersible tablet Launch in Japan
2014
36
2013 pipeline delivery
Regulatory
approvals
Farxiga (US)
Xigduo (dapagliflozin+metformin)
(EU)
Fluenz Tetra (EU)
Regulatory
submissions
Epanova (US)
Metreleptin (US)
Olaparib (EU)
Naloxegol (US & EU)
Bydureon dual chamber pen (US & EU)
Phase III
starts
Olaparib in BRCAm Ovarian Cancer
Moxetumomab in hairy cell leukaemia
Benralizumab in severe asthma
Selumetinib in 2nd line KRASm NSCLC
Pipeline
progression
AZD9291 Phase I data
MEDI4736 (PD-L1) Phase I data
MEDI0680 (PD-1) first dose in human
Multiple IMT-C combination trials initiated
Faster than anticipated pipeline progression & re-deployed R&D spend toward late development
Target of 10 potential NMEs in Phase 3
pipeline by 2016 achieved already in 2013
Pipeline progression driving shift
toward late development
9-10
8 6
2016 2013 2012
11
10
8
6
Nu
mb
er
of
NM
Es
in
Ph
as
e 3
pip
eli
ne
Plan Actual
21%
32%
2013 estimate
Late
Development
Early
Development
& Discovery
38%
60%
40%
2013 actual
55%
45%
2014 estimate
50%
50%
38
A growing and accelerating late stage pipeline
Oncology RIA CVMD Neuroscience Infection
CAZ AVI BLI/cephalosporin SBI
Phase 1
33 New Molecular Entities
Small molecule Large molecule
AZD5363 AKT solid tumours
AZD2014
TORK solid tumours
AZD6094 (volitinib) MET solid tumours AZD1208 PIM haems AZD9150 STAT3 haems + solids AZD9291 EGFRm+ solid tumours
AZD8186 PI3Kβδ solid tumours
AZD8848 Inhaled TLR7 agonist asthma AZD7624 Inhaled p38 inhibitor COPD AZD4721 CXCR2 COPD
AZD3293 BSECDR Alzheimer's
MEDI0639 DLL-4 solid tumours MEDI-565 CEA BiTE GI tumours MEDI3617 ANG-2 solid tumours MEDI6469 mOx40 solid tumours
Phase 2
27 New Molecular Entities
Small molecule Large molecule
selumetinib MEK 2L KRAS NSCLC
ATM AVI BL/BLI SBI
AZD4547 FGFR solid tumours
Epanova hypertriglyceridaemia naloxegol opioid induced constipation
Olaparib PARP BRCA ovarian, gastric
metreleptin lipodystrophy
Phase 3
11 New Molecular Entities
Small molecule Large molecule
moxetumomab CD22, HCL brodalumab IL-17R psoriasis benralizumab
IL-5R asthma
AZD1775 Wee-1 ovarian
AZD6423 NMDA suicidal ideation
AZD1419 TLR9 asthma
AZD0914 GHyrAR serious infection
AZD6738 ATR CLL/H&N
PT010 LABA/LAMA/ICS COPD
MEDI0680 PD-1 solid tumours
AZD4901
Hormone modulator PCOS
MEDI4736 PD-L1 solid tumours
MEDI-573 IGF MBC MEDI-551 CD19 CLL, DLBCL tremelimumab CTLA-4 mesothelioma sifalimumab (SLE) IFNa SLE
MEDI-546 IFNaR SLE
MEDI-551 CD19 MS
MEDI5872 B7RP1 SLE MEDI9929 TSLP asthma
MEDI6012 LCAT, ACS MEDI4893 staph alpha toxin SSI MEDI-559 (PRVV) RSV prophylaxis MEDI-550 Panflu library MEDI9287 H7N9 avian influenza
MEDI4736+tremelimumab PD-L1+CTLA-4 solid tumours MEDI4736+dabraf+trametinib PD-L1+BRAF+MEK melanoma
MEDI8968 IL-1R COPD, HS mavrilimumab GM-CSFR RA MEDI7183 α4β7 UC, Crohn’s tralokinumab IL-13 asthma, IPF MEDI2070 IL-23 Crohn’s
RDEA3170 URAT1 - gout
AZD5069 CXCR2 antagonist asthma AZD2115 MABA (dual) COPD
AZD3241 MPO Parkinson's Disease AZD5213 H3R Tourette’s/neuropathic pain
AZD5847 oxazolidinone TB CXL BLI/cephalosporin MRSA
roxadustat (AZD9941) HIF anaemia CKD/ESRD
AZD1722 NHE3 inhibitor ESRD/CKD
lesinurad URAT1 gout PT003 LABA/LAMA COPD
moxetumomab CD22, pALL
olaparib PARP breast selumetinib MEK haems + solids
brodalumab IL-17R asthma/psoriatic arthritis
benralizumab
IL-5R COPD
39
19 candidates for NME registration trial starts in 2014-15
2014 2015
AZD9291
NSCLC
AZD4547
gastric cancer
ATM AVI
serious infections
MEDI4736
solid tumours
MEDI-573
metastatic breast cancer
RDEA 3170
gout
tralokinumab
asthma
MEDI-551
CLL
sifalimumab/MEDI-546
systemic lupus erythematosus
roxadustat (FG4592)
ESRD/CKD
volitinib (AZD6094)
papillary renal cell carcinoma
Pearl Triple PT010
COPD
AZD3293
Alzheimer’s
AZD1775
ovarian cancer
AZD5069
asthma
mavrilimumab
rheumatoid arthritis
MEDI3617
ovarian cancer
AZD1722
ESRD
AZD9150
DLBCL
40
We anticipate 4-5
NME registration
trials
Potential NME registration trial starts in 2014
2014
AZD9291
NSCLC
MEDI4736
solid tumours
tralokinumab
asthma
roxadustat (FG4592)
ESRD/CKD
AZD3293
Alzheimer’s
mavrilimumab
rheumatoid arthritis
MEDI4736 (anti-PD-L1) Empowering the Immune System to Fight Cancer
Novel approach, supporting multiple
combination opportunities
Encouraging level of clinical activity in
Phase I dose-escalation1
• Validated pathway
• Strong scientific rationale for combinations
• Phase I dose-escalation/expansion
monotherapy in solid tumours &
combination trials ongoing, data at ASCO
and ESMO
• Monotherapy phase III start anticipated
in 2014
• PYS potential >$1bn
Ch
an
ge
Fro
m B
as
eli
ne (
%)
100
75
50
25
0
−25
−50
−75
−100
0 50 100 150 200 250
Tumor Assessments (Day)
1 Khleif S, et al. Data presented at an oral session at ECCO/ESMO conference, Amsterdam, Netherlands, 27 Sep - 1 Oct 2013
AZD9291 (3rd generation EGFR-TKI) A novel small molecule targeting key genetic segment in NSCLC
Leading the way in area of high
unmet medical need
Encouraging evidence of
monotherapy activity1
1 Ransom M, et al. Data presented at a mini-oral session at the 15th World Conference of Lung Cancer, Sydney, Australia, 27-30 October 2013
• Oral irreversible inhibitor of both EGFR
sensitising and EGFR T790M resistance
mutations
• Phase I dose-escalation & cohort expansion
in EGFR T790M mutant NSCLC ongoing,
further data at ASCO
• Anticipated to enter Phase III in 2014
• PYS potential >$1bn
Best % change from baseline in target lesions, n=34
% c
ha
ng
e f
rom
ba
seli
ne
in
targ
et
lesio
n
40
20
10
0
–10
–20
–30
–40
–50
–60
–70
–80
–90
–100
30 40
40 40*
40
40 40
40
40 40
40
40
20
20
20
20
20 20 20 20
20 20
20 20
20 20 20
20
20*
D
D D D
D
D§
D§
80
80 80
80
80 80
T790M status
Negative
Positive
Unknown
D Discontinued treatment
* Imputed § Progressive disease due to new lesion
Dose (mg/day) received noted on bar
Population: patients with observed or imputed target lesion data (n=34)
Best overall response#
• 15/35 patients evaluated had a partial response (confirmed + unconfirmed)
• 9/18 patients with T790M+ tumours achieved a partial response (confirmed + unconfirmed)
Preliminary data, cut-off 27 September 2013
#Response Evaluation Criteria in Solid Tumors v1.1, programmatically calculated from investigator-recorded tumour measurements
T790M result from local testing except for some expansion patients where local testing result unknown (central test result used)
Roxadustat/FG4592 Anaemia treatment beyond the boundaries of current ESA therapy
Stimulates EPO production without need
for concomitant iron treatment
First in Class oral HIF-PHD inhibitor
for CKD & ESRD
• Potential first HIF-PHD inhibitor with filing in
2016 (China) and 2018 (US)
• Potential use in Anaemia of Chronic Kidney
Disease (CKD) and End Stage Renal Disease
(ESRD)
• High unmet need for oral agent with
improved safety profile
• Anticipated to enter Phase III in 2014
• PYS Potential >$1bn
AZD3293 (BACE1 inhibitor) Highly potent inhibitor of the first step in Aβ peptide production
Highly promising approach to address
unmet medical need in Alzheimer’s CSF A 42
Day 14 Mean Profiles
AZD3293 (BACE) MAD
Time (hr)
0 3 6 9 12 15 18 21 24
CSF
A42
(% o
f Day
-1 B
asel
ine)
-100
-75
-50
-25
0
25
50
75
Placebo (n=3)
Cohort 1 - 15 mg AZD3293 QD
Cohort 2 - 50 mg AZD3293 QD
CS
F A
4
2 (
% o
f D
ay -
1 B
ase
line
)
Placebo
15mg AZD3293
Time (hours post-dose)
50mg AZD3293
• Alzheimer’s disease pathology is
characterised by A peptide deposition
• Disease causing mutations in APP directly
linked to BACE activity
• Potential to slow disease progression in
prodromal and mild Alzheimer’s disease
• Anticipated registrational trial start in 2014
• PYS potential >$1bn
AZD3293 has demonstrated significant dose
dependent reduction in CSF A in Phase 11
1 Budd H. S. et al (2013) AZD3293 a novel BACE1 inhibitor: Effect on plasma and CSF Abeta peptides following single and multiple-dose administration. Journal of Nutrition, Health and Aging Issue 9, Vol 17
45
Potential NME and LCM submissions 2014-2016
olaparib US
gBRCAm PSR ovarian cancer
PT003
LABA/LAMA COPD
benralizumab
IL-5R asthma
lesinurad
URAT1 gout
brodalumab
IL-17R psoriasis
AZD9291
EGFRm+ solid tumours
CAZ AVI EU
BLI/cephalosporin SBI
metreleptin EU
lipodystrophy
roxadustat (FG4592) CH
HIF anaemia CKD/ESRD
Bydureon Dual Chamber Pen JP
GLP-1 receptor agonist
Brilinta PEGASUS US/EU/JP
ADP receptor antagonist
Brilinta EUCLID US/EU/JP
ADP receptor antagonist
Onglyza SAVOR-TIMI US/EU
DPP-4 inhibitor
Bydureon Autoinjector US/EU
GLP-1 receptor agonist
Brilinta SOCRATES US/EU/JP
ADP receptor antagonist
saxa-dapa FDC US/EU
DPP-4 inhibitor
Iressa IMPRESS EU/JP/CH
EGFRm+ NSCLC
Caprelsa US/EU/JP
differentiated thyroid cancer
Iressa US
EGFRm+ NSCLC
Faslodex US/EU/JP/CH
Oestrogen receptor antagonist
olaparib SOLO-2 US/EU/JP/CH
gBRCAm PSR ovarian cancer
Lesinurad FDC US/EU
URAT1 gout
Oncology
RIA
CVMD
Key:
2016 2015 2014
Infection
46
AstraZeneca 2013 Full Year Results
47
Closing remarks
Pascal Soriot
Chief Executive Officer, AstraZeneca
48
Q3 Q2 Q1 Q4
Carrying momentum into 2014
Epanova, Severe
Hypertriglyceridaemia
PDUFA, May 5
Benralizumab, Tralokinumab
ATS P2 Results Presentations
Analyst Meeting
ATS, May 16 – 21
Medi 4736, Olaparib, AZD 9291
ASCO Results Presentations
Analyst Meeting
ASCO, May 30 – June 3
Saxagliptin/Dapagliflozin,
Type 2 Diabetes
Data In Combined Usage
Bydureon Dual Chamber Pen,
Type 2 Diabetes
Potential FDA Approval
Iressa, NSCLC
Submission US
Olaparib, Ovarian Cancer Platinum
Relapsed
Potential US Approval
CAZ-AVI, Complicated Intra-
Abdominal Infections
P3 Results
Immuno-oncology monotherapy
ESMO Results Presentations
Naloxegol, Opioid Induced
Constipation
PDUFA, September 16
PT-003, COPD
P3 Results
Brodalumab, Psoriasis
P3 Results
Olaparib, Ovarian Cancer Platinum
Relapsed
Potential EU Approval
Dapagliflozin+saxagliptin FDC,
Type 2 Diabetes
FDA Submission
Xigduo XR FDC, Type 2 Diabetes
Potential FDA Approval
Lesinurad, Gout
P3 Results (ACR) and Submission
EU & US
Bydureon Dual Chamber Pen,
Type 2 Diabetes
Potential EU Approval
Farxiga, Type 2 Diabetes
FDA Approval
Dapagliflozin, Type 2 Diabetes
Potential Approval Japan
Olaparib, Ovarian Cancer Platinum
Relapsed
US Submission
Xigduo, Type 2 Diabetes
EU Approval
Naloxegol, Opioid Induced
Constipation
US Ad Comm, postponed
49
Ruud Dobber, EVP, Europe & EVP Global
Portfolio & Product Strategy
(interim)
Bahija Jallal, EVP, MedImmune
Mene Pangalos, EVP, Innovative Medicines
& Early Development
50
AstraZeneca 2013 Full Year Results