Full-Year and Q4 2017 Results - Live presentation, conference call and webcast for investors and analysts 2 February 2018 - AstraZeneca
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Full-Year and Q4 2017 Results Live presentation, conference call and webcast for investors and analysts 2 February 2018
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 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; effects of patent litigation in respect of IP rights;
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 that R&D will not yield new products that achieve commercial success; the risk
of delay to new product launches; the risk that new products do not perform as we expect; the risk that strategic alliances and acquisitions, including licensing and
collaborations, will be unsuccessful; the risks from pressures resulting from generic competition; the impact of competition, price controls and price reductions; the
risks associated with developing our business in emerging markets; the risk of illegal trade in our products; the difficulties of obtaining and maintaining regulatory
approvals for products; the risk that regulatory approval processes for biosimilars could have an adverse effect on future commercial prospects; the risk of failure to
successfully implement planned cost reduction measures through productivity initiatives and restructuring programmes; the risk of failure of critical processes affecting
business continuity; economic, regulatory and political pressures to limit or reduce the cost of our products; failure to achieve strategic priorities or to meet targets,
expectations, guidance or indications 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 impact of increasing implementation and enforcement of more stringent anti-bribery and anti-corruption legislation; taxation
risks; exchange rate fluctuations; 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 impact of failing to attract and retain key personnel and to
successfully engage with our employees; the risk of misuse of social medial platforms and new technology; and the risk of failure of information technology and
cybercrime. Nothing in this presentation or any related webcast should be construed as a profit forecast.
2
Presenters
Pascal Soriot Mark Mallon Dave Fredrickson
Executive Director and Executive Vice President, Executive Vice President and
Chief Executive Officer Global Products & Portfolio Head, Oncology Business Unit
Strategy, Global Medical
Affairs, Corporate Affairs
Marc Dunoyer Sean Bohen
Executive Director and Executive Vice President,
Chief Financial Officer Global Medicines Development
and Chief Medical Officer
3
Agenda
Overview
Growth Platforms
Pancreatic beta cells at different
stages of regeneration: AstraZeneca
is investing in research that could
Oncology stimulate the regeneration of beta
cells in the pancreas with the aim of
stopping the progression of, or
reversing, the course of diabetes.
Finance
Pipeline and news flow
Closing and Q&A
4
Highlights
Full-Year 2017: Encouraging progress across the company
Business & financials
Total Revenue declined by 2%, with Product Sales improving during the year (+3% Q4 vs. -5% FY)
Product Sales
• Oncology: Encouraging growth across all major medicines
• CVMD*: Brilinta (+29%) and Farxiga (+28%) now blockbusters (>$1bn)
• Respiratory: Quarterly Symbicort improvement; Fasenra launch
• Emerging Markets: +8%; accelerating in Q4
• China: +15%, including growth of +30% in Q4
Core EPS better than expected due to Product Sales, including sales true-ups, and tax rate
Guidance: FY 2018
• A low single-digit percentage increase in Product Sales and Core EPS in the range of $3.30 to $3.50
Sustainability
• AstraZeneca ranked 34th in Corporate Knights’ 14th annual Global 100 list of the most sustainable companies in the world
• AstraZeneca identified as a ‘biggest achiever’ for a 300% increase in renewable electricity in a single year
* Cardiovascular and Metabolic Diseases.
Absolute values at actual exchange rates; change at Constant Exchange Rates (CER) and for FY 2017, unless otherwise stated.
Guidance at CER.
5
Highlights continued
News flow continued at high speed in the period
Pipeline developments
Oncology • Faslodex breast cancer (combinations) Approval (US, EU)
• Lynparza ovarian cancer 2L Approval (JP), Priority review (CN)
breast cancer Approval (US)
• Tagrisso lung cancer 1L (FLAURA) Regulatory submission acceptance
(US - Priority Review, EU, JP)
Cardiovascular and • Bydureon + insulin type-2 diabetes Approval (EU)
Metabolic Diseases • ZS-9 hyperkalaemia Regulatory submission (US)
CHMP positive opinion reiterated (EU)
• roxadustat anaemia Priority review (CN)1
Respiratory • Fasenra (benralizumab) severe, uncontrolled asthma Approval (US, EU, JP)
• PT010 COPD2 Phase III KRONOS trial - most primary endpoints
met3
• tezepelumab severe, uncontrolled asthma Phase III programme initiated
1. By partner Fibrogen.
2. Chronic obstructive pulmonary disease.
3. Eight of the nine primary endpoints in the KRONOS trial were met, including two non-inferiority endpoints to qualify PT009, one of the comparators.
Status since the previous results announcement on 9 November 2017.
6Product Sales: Improving momentum
US patent losses
(Crestor/Nexium/Seroquel)
Externalisation
Other out-of-patent medicines Emerging Markets
(outside Emerging Markets) (established medicines)
Respiratory
+6%
Oncology FY 2017
Brilinta & Diabetes
(+11% Q4 2017)
FY 2012 FY 2013 FY 2014 FY 2015 FY 2016 FY 2017
Absolute values and change at CER.
72017: A defining year
Launches of new medicines Some of the key news flow
from main therapy areas opportunities we had in 2017
ü Imfinzi ü ZS-9 û Fasenra ü
bladder cancer hyperkalaemia asthma
ü reg. decision reg. decision reg. decision
ü Imfinzi ü Imfinzi û Tagrisso ü
Imfinzi + treme
ü NSCLC* Stage III
PACIFIC PFS
NSCLC 1L
MYSTIC PFS
NSCLC 1L
FLAURA
ü
Lynparza ü Calquence ü
2012 2013 2014 2015 2016 2017 multiple cancers blood cancer
reg. decision reg. decision
* Non-small cell lung cancer.
82018: Focus on return to growth
Momentum improved during 2017
Significantly-improved momentum Many opportunities to support growth in 2018
(FY 2010 - Q4 2017 Product Sales growth)
Lynparza Tagrisso Imfinzi
launched tablet launch in 1st line lung launch in Stage III lung
launched in breast cancer cancer (FLAURA trial) cancer (PACIFIC trial)
Diabetes
Alliance
Product Sales growth (%)
BMS
Brilinta Farxiga
continued global continued global growth,
growth DECLARE trial
Crestor Fasenra
loss of exclusivity launched in severe,
(EU, JP) uncontrolled asthma
FY FY FY FY FY FY FY Q1 Q2 Q3 Q4
2010 2011 2012 2013 2014 2015 2016 2017 2017 2017 2017 Low single-digit percentage increase in Product Sales
Change (Product Sales growth) and 2018 guidance at CER.
9Agenda
Overview
Growth Platforms
Pancreatic beta cells at different
stages of regeneration: AstraZeneca
is investing in research that could
Oncology stimulate the regeneration of beta
cells in the pancreas with the aim of
stopping the progression of, or
reversing, the course of diabetes.
Finance
Pipeline and news flow
Closing and Q&A
10Growth Platforms: Improved momentum
China and New Oncology were top contributors
Q4 2017 % Total % Product FY 2017 % Total % Product
% change Revenue Sales
% change Revenue Sales
$m $m
Growth Platforms 4,180 12 72 76 15,231 6 68 76
Emerging Markets 1,630 9 - - 6,149 8 - -
Respiratory 1,334 8 - - 4,706 (1) - -
New CVMD 1,024 21 - - 3,567 9 - -
Japan 563 2 - - 2,208 4 - -
New Oncology 437 100 - - 1,313 98 - -
Total Product Sales for Growth Platforms are adjusted to remove duplication on a medicine and regional basis.
Product Sales values at actual exchange rates; change at CER.
11Main therapy areas: Growth in all areas
New framework for reporting of Product Sales
Q4 2017 % Product FY 2017 % Product
% change % change
$m Sales $m Sales
Product Sales 5,487 3 100 20,152 (5) 100
Oncology 1,120 19 20 4,024 19 20
New CVMD 1,024 21 19 3,567 9 18
Respiratory 1,334 8 24 4,706 (1) 23
Emerging Markets 1,630 9 30 6,149 8 31
The individual components of Product Sales do not add up due to overlaps in Emerging Markets and the omission of products outside the three main therapy areas.
Product Sales values at actual exchange rates; change at CER.
12Emerging Markets
China growth accelerated
Product Sales accelerated China growth was a highlight;
Long-term target: Mid to high single-digit other EMs solid overall
9%
12% 12% 8% • Mid to high single-digit growth in EMs continued
Emerging Markets
Emerging Markets
8% 8%
• Growth impacted by economic conditions in Russia
6% and parts of LatAm/MEA*
4%
• Oncology +20%: Lung cancer $0.4bn; Iressa (+8%)
FY FY FY FY FY FY
and Tagrisso launched. Hormone-receptor medicines
2012 2013 2014 2015 2016 2017 Q4 2017 FY 2017 $0.7bn with Faslodex (+18%)
22%
17%
19% 30% • New CVMD +23%: Key medicines continued to grow;
15% 15%
Brilinta (+21%) and Forxiga, largest Diabetes
China
China
10%
15% medicine (+73%)
• Respiratory +13%: Continued double-digit growth for
FY FY FY FY FY FY Pulmicort (+23%; 61% of total); Symbicort (+10%)
2012 2013 2014 2015 2016 2017 Q4 2017 FY 2017
* Latin America and Middle-East & Africa.
Change at CER.
13Emerging Markets - additional analysis
Strong growth driven by underlying demand
Impact of partnerships and divestments China Inventory
• China growth reduced by • Emerging Markets outside China • China growth was not materially
partnerships and divestments kept good momentum when impacted by inventory changes
adjusting for partnerships and
divestments 49 48 47
22% 41 43
37 39 37 39
35 36
Emerging Markets (excl.
18%
China Growth Rate
7%
Inventory Days
8%
China
China)
22% 5%
19% 10% 4%
15% 15% 8%
1% 3%
10%
4%
3%
2%
FY 013
FY 014
1 5
Q 016
Q 016
Q 016
Q 016
Q 017
Q 017
Q 017
17
Q 01
20
2
2
2
2
2
2
2
2
2
2
2
3
4
1
2
3
4
FY 2013 FY 2014 FY 2015 FY 2016 FY 2017 FY 2013 FY 2014 FY 2015 FY 2016 FY 2017
FY
Chart legend: Product Sales Partnerships and divestments Chart legend: Product Sales Partnerships and divestments Chart legend: 2012 2013 2014 2015 2014 2015
Change at CER.
14Respiratory
Symbicort sustained in a competitive market
Steady Pulmicort growth Symbicort US and Europe Global focus: Emphasis on
$m market share stable Symbicort’s competitive profile
1,500 5,000
-1%
8% US -8%
3% • Symbicort access maintained, but
US 5-week NBRx
15% 33.0%
market share
4,000 pricing pressure remained despite
12%
26% some improvement in H2 2017
1,000
• Growth in new medicines
Jan-17
Feb-17
Mar-17
Apr-17
May-17
Jun-17
Jul-17
Aug-17
Sep-17
Oct-17
Nov-17
Dec-17
3,000
• Daliresp (+25%); Bevespi
-6% progressed
0%
2,000
500 Europe -5%
• Overall stable Symbicort volume
Europe volume
30.0%
market share
1,000
Emerging Markets +13%
Nov-16
Dec-16
Jan-17
Feb-17
Mar-17
Apr-17
May-17
Jun-17
Jul-17
Aug-17
Sep-17
Oct-17
Nov-17
0 0
Q4 2017 FY 2017
Chart legend: Symbicort Pulmicort Others NBRx = New-to-brand prescriptions.
Absolute values at actual exchange rates; change at CER. Source: IQVIA, formally Quintiles IMS Holdings, Inc..
15Fasenra: Our first respiratory biologic 28-51% 1
Now approved in the US, the EU and Japan reduction in the annual asthma
exacerbation rate versus placebo
116-159mL 1
significant improvement in lung
function as measured by forced
expiratory volume in one second
(FEV1) versus placebo
75%
reduction in median OCS2 dose
1
from baseline (vs 25% for placebo)
and discontinuation of OCS use in
52% of eligible patients
1. Source: Summary of product characteristics, AstraZeneca data on file.
2. Oral corticosteroids
16New CVMD
Brilinta and Farxiga each reached >$1bn milestone
Brilinta: Blockbuster Diabetes: Farxiga blockbuster Commercial focus maintained
$m US NBRx continued to grow $m Global leadership ongoing on the two largest medicines
800 2,500 2%
20%
300 1,000
Brilinta +29%
2,000
-8% 21% 600 2% -1% • Sustained solid growth in all
200 1,500
15% 13% 400 19% -16% regions
500 1,000
100 47% 46% 37% 28%
200 500
Farxiga +28%
0 0 0 0
Q4 2017 FY 2017 Q4 2017 FY 2017
• US (+7%) continued growth;
stable share in a growing market
Brilinta Competitor Farxiga Competitor 1
16.6% Competitor 2
40.6%
• Ex-US (54% of total)
Continuous strong growth, e.g.
34.9%
4.2% Emerging Markets (+73%),
17.0% Europe (+28%)
Jun-16
Sep-16
Dec-16
Jun-17
Sep-17
Dec-17
Nov-16
Aug-17
Nov-17
Mar-17
Feb-17
May-17
Chart legend: US Europe Emerging Markets Established Rest of World Chart legend: Farxiga Onglyza Bydureon Byetta Others
Absolute values at actual exchange rates; change at CER. Source: IQVIA, formally Quintiles IMS Holdings, Inc., Farxiga: Includes fixed-
Source: IQVIA, formally Quintiles IMS Holdings, Inc., dose combinations.
17Japan
Tagrisso supported the sustained growth; Crestor offset
Growth ongoing Key medicines remained Tagrisso: Back to growth
$m +2% Q4; +4% FY volume-share leaders $m after Ryotanki1 lift in Q2
600 2,400 • Symbicort
In-market growth; sales reduced by
-11% 0% tough comparison and partner buying 70
2,000 64
67% n/m 61
• Tagrisso 60 55
400
-6%
1,600
4% Continued strong growth; sequential
maturation due to 90%+ testing and 50
prescription rate 39 39
-21% 1,200 -4% 40
• Nexium 28
Tough comparison; remained market 30
10%
200 800 -6% leader in the class
20 15
400
• Crestor
10
Decline as a result of 20+ generic
0
competitors 0
0 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Q4 2017 FY 2017 • New approvals: Lynparza and Fasenra 2016 2016 2016 2016 2017 2017 2017 2017
Chart legend: Other Crestor Nexium Tagrisso Symbicort 1. Ryotanki: Regulation in Japan that restricts prescriptions for
Absolute values at actual exchange rates; change at CER. medicines in their first year on the market to just two weeks.
18Oncology
Growth being delivered
Oncology Product Sales
$m New medicines boosting growth • Total Oncology +19%
1,200
• 20% of total Product Sales
1,000
• Faslodex approaching $1bn
800
• Six new medicines 2014-2020, with four
600
delivered
400
• Lynparza: Growth accelerating
200
• Tagrisso: Success in 2L; preparing for 1L
0
• Imfinzi: Q4 inflection point
14
14
14
14
15
15
Q 15
Q 015
Q 16
Q 16
Q 16
Q 17
Q 17
Q 17
17
Q 16
20
20
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2
1
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1
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• Calquence: Encouraging early uptake
1
Q
Q
Q
Q
Q
Q
Q
Othe r Zo ladex Fa slodex Ire ssa Lynparza Ta grisso Imfin zi Calquence
Absolute values at CER.
19Lynparza
The leading PARP inhibitor with revitalised US growth
Continued strong growth Strong US sales momentum MRK collaboration update
$m +58% Q4; +35% FY Europe awaiting new tablet
• US +11%, but +74% in Q4 • Continued integration of both
Continued strong growth; development and commercial
100
launch of tablets and the broad efforts
label in OC1
80
• Joint US field force being
60
• Europe +58% deployed. Other countries to follow
Steady progress in 2L OC;
40
awaiting tablet label
20
• Next commercial milestones
• BC2 launch in US (ongoing)
0 • First launch in Japan; OC
(ongoing) followed by BC (H2)
2 5
3 5
4 5
1 5
2 6
3 6
4 6
1 6
2 7
3 7
4 7
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Q 01
Q 01
Q 01
Q 01
Q 01
Q 01
Q 01
Q 01
Q 01
Q 01
Q 01
20
• Tablets in Europe (H1)
2
2
2
2
2
2
2
2
2
2
2
1
Q
Chart legend: US Europe Emerging Markets Established Rest of World 1. Ovarian cancer.
Absolute values at actual exchange rates. 2. Breast cancer.
20Tagrisso and Imfinzi
Q4: Accelerating growth
Tagrisso Imfinzi
$m 68 approvals; 16 awaited
350 • US +59% • Product sales $19m; $18m in Q4
Higher testing rates of ~70%
300 underpinned continued growth; • Current approvals
preparing for 1st-line launch 2nd-line bladder cancer: US (3rd
250 in the market), Brazil, Canada,
• Europe +142% and Israel
200
Testing rates generally below US;
150 France leading, momentum from • Next steps
launches in Italy and Germany Launch in Stage III unresectable
100 lung cancer*
• Japan
50
Back to sequential growth
0
• Emerging Markets
15
15
16
16
16
16
17
17
17
17
20
20
20
20
20
20
20
20
20
20
China, other launches
3
4
1
2
3
4
1
2
3
4
Q
Q
Q
Q
Q
Q
Q
Q
Q
Q
Chart legend: US Europe Emerging Markets Established Rest of World * Imfinzi is not yet approved in lung cancer.
Absolute values at actual exchange rates.
21Global launches underway Building out the new medicines 22
Agenda
Overview
Growth Platforms
Pancreatic beta cells at different
stages of regeneration: AstraZeneca
is investing in research that could
Oncology stimulate the regeneration of beta
cells in the pancreas with the aim of
stopping the progression of, or
reversing, the course of diabetes.
Finance
Pipeline and news flow
Closing and Q&A
23Reported Profit & Loss
FY 2017 % Total Q4 2017 % Total
% change % change
$m Revenue $m Revenue
Total Revenue 22,465 (2) 100 5,777 2 100
- Product Sales 20,152 (5) 90 5,487 3 95
- Externalisation Revenue 2,313 38 10 290 (12) 5
Gross Margin 79.6% (1) pp* - 77.6% (-) pp -
R&D Expenses 5,757 (1) 26 1,551 (2) 27
SG&A Expenses 10,233 10 46 3,078 n/m 53
Other Operating Income 1,830 11 8 848 (25) 15
Tax Rate -29% - - -210% - -
EPS $2.37 (15) $1.03 (24)
* Percentage points.
Absolute values at actual exchange rates; change at CER.
Gross Margin reflects Gross Profit derived from Product Sales, divided by Product Sales.
24Core Profit & Loss
FY 2017 % Total Q4 2017 % Total
% change % change
$m Revenue $m Revenue
Total Revenue 22,465 (2) 100 5,777 2 100
- Product Sales 20,152 (5) 90 5,487 3 95
- Externalisation Revenue 2,313 38 10 290 (12) 5
Gross Margin 81.2% (1) pp - 79.4% 1 pp -
R&D Expenses 5,412 (3) 24 1,456 (4) 25
SG&A Expenses 7,853 (3) 35 2,175 5 38
Other Operating Income 1,953 14 9 852 (26) 15
Tax Rate 14% - - 3% - -
EPS $4.28 (2) $1.30 13
Absolute values at actual exchange rates; change at CER.
Gross Margin reflects Gross Profit derived from Product Sales, divided by Product Sales.
25Externalisation Revenue
Ongoing income increased
Increasing contribution from Ongoing Key observations
$m Externalisation Revenue, incl. MRK
1,600
• Ongoing Externalisation Revenue of $821m in 2017
1,400
1,200
MRK collaboration benefit
1,000
800
• 2017: $1.85bn; ~$1.25bn in Externalisation Revenue
600 • Further income in the years to come
400 • First approval milestone of $70m in Q1 2018
200 • Remaining option payments of $500m in 2018-2019
0 • Regular milestones; approval (~1/3) and sales-
14
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20
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20
20
20 related (~2/3); mono and combo therapy up to
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Q
Q
Total Ongoing Externalisation Revenue MRK Collaboration Initial Revenue ~$6bn remaining
Absolute values at actual exchange rates.
26Continued progress and focus on cost discipline
Reduction in Core R&D costs: -3% FY 2017 Continued reduction in Core costs
$m
1,500
1,000 • Core R&D costs
500
• FY 2017: Down by 3%
0
Investment concentrated in main therapy areas
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• FY 2018: Anticipated to be in the range of a low
Oncology CVMD Respiratory Other
$m single-digit percentage decline to stable
Reduction in Core SG&A costs: -3% FY 2017
4,000 • Core SG&A costs (split in SMM1 and G&A2)
3,000
2,000 • FY 2017: Down by 3%
1,000
0
Investment increasingly in Sales support vs G&A
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20 • FY 2018: Anticipated to be increase by a low to mid
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General and admin Sales, marketing and medical single-digit percentage
1. Sales, marketing and medical
2. General and admin
Absolute values at actual exchange rates; change at CER.
27Focus: Cash flow
Detailed breakdown
$m
(0.1)
1.1
1.3
0.2 0.6
0.1
(0.5)
(0.1)
2016 net cash inflow Reduction in cash Higher tax & interest Lower purchase of Lower purchase of Lower upfront Other 2017 net cash inflow
before financing generated from paid property, plant and intangible assets payments on business before financing
activities operations equipment combinations activities
Absolute values at actual exchange rates.
282018 Guidance and unchanged capital-allocation priorities
Unchanged capital-allocation priorities
Product Sales • Investment in the business
A low single-digit percentage increase
• Progressive dividend policy
• Strong, investment-grade credit rating
Core EPS
$3.30 to $3.50 • Immediately earnings-accretive, value-
enhancing opportunities
Guidance at CER.
29Agenda
Overview
Growth Platforms
Pancreatic beta cells at different
stages of regeneration: AstraZeneca
is investing in research that could
Oncology stimulate the regeneration of beta
cells in the pancreas with the aim of
stopping the progression of, or
reversing, the course of diabetes.
Finance
Pipeline and news flow
Closing and Q&A
30Q4 2017 late-stage pipeline update
Oncology Cardiovascular and Respiratory
• Metabolic Diseases •
• Faslodex - breast cancer • Bydureon + insulin - type-2 • Symbicort - asthma (safety):
(combinations): Approval (US, EU) diabetes (DURATION-7 trial): Approval (US)
Approval (EU)
• Lynparza • Fasenra - severe, uncontrolled
- ovarian cancer 2L: Approval (JP), • ZS-9 asthma: Approval (US, EU, JP)
priority review (CN) - hyperkalaemia: Regulatory
- breast cancer: Approval (US) submission acceptance (US) • PT010 - COPD: Phase III
- CHMP reiterated previous KRONOS trial met 8 of 9 primary
• Tagrisso - lung cancer 1L positive opinion (EU) endpoints2
(FLAURA): Regulatory submission
acceptance (US - Priority Review, • roxadustat - anaemia: Priority • tezepelumab - severe,
EU, JP) review (CN)1 uncontrolled asthma: Phase III
programme initiated (NAVIGATOR
trial)
1. By partner Fibrogen.
2. Including two non-inferiority endpoints to qualify PT009, one of the comparators.
Status since the latest results announcement on 9 November 2017.
31Oncology
FLAURA and PACIFIC regulatory submissions moving fast
in lung cancer
FLAURA and PACIFIC regulatory status
Activity Region Timing
Regulatory submission US, EU, JP H2 2017
Priority Review US
Regulatory decision US H1 2018
EU, JP H2 2018
Tagrisso and Imfinzi Imfinzi
submissions submission
32Cardiovascular and Metabolic Diseases
Key 2018 Phase III readouts
Roxadustat Phase III programme
Farxiga DECLARE Phase III trial
First-in-class, anti-anaemia potential new medicine
• Primary efficacy endpoints Patient population Company Phase III trial
• Superiority for MACE (CV death, non-fatal
myocardial infarction or non-fatal stroke) ANDES
• Superiority for the composite endpoint of CV death
OLYMPUS
or hospitalisation for heart failure Anaemia in CKD patients
not receiving dialysis
ALPS
• Primary safety endpoint
• Non-inferiority for MACE DOLOMITES
SIERRAS
• Data anticipated in H2 2018 Anaemia in CKD in
patients receiving dialysis ROCKIES
~17,000 patients PYRENEES
including patients with multiple CV risk factors
(~10,000) or established CVD* (~7,000) Anaemia in newly- HIMALAYAS
initiated dialysis patients
*Cardiovascular disease
In partnership with Fibrogen and their collaborator Astellas.
33Respiratory
Late-stage pipeline programmes delivering
PT010 Tezepelumab Fasenra
Triple combination therapy Phase III programme Data for severe
(COPD, asthma) PATHFINDER (severe asthma) COPD in 2018
• Eight of the nine primary endpoints in • First Phase III trial NAVIGATOR • Approved in severe, uncontrolled
the Phase III KRONOS trial were initiated enrolment in Q4 asthma
met1
• Phase III programme based on • Phase III VOYAGER programme
• PT010 demonstrated a statistically- results from the Phase IIb PATHWAY evaluating the efficacy and safety
significant improvement in six out of trial of Fasenra in patients with severe
seven lung-function primary COPD
endpoints2 • Results published in the New
England Journal of Medicine and • Data readout anticipated in H2 2018
• Results to be presented at a presented at the European
forthcoming medical meeting Respiratory Society Congress
• Regulatory • Potential to help a broad group of
submission patients; including those without
anticipated presence of a Th2 biomarker
in H2 2018
1. Including two non-inferiority endpoints to qualify PT009, one of the comparators.
2. Improvement compared with dual combination therapies.
34Late-stage pipeline news flow in 2018 and 2019
Unlocking and realising the potential of new medicines
H1 2018 H2 2018 2019
Regulatory decision Lynparza - ovarian cancer 2L (EU) Lynparza - breast cancer (JP)
Tagrisso - lung cancer (US) Tagrisso - lung cancer (EU, JP)
Imfinzi - lung cancer (PACIFIC) (US) Imfinzi - lung cancer (PACIFIC) (EU, JP)
ZS-9 - hyperkalaemia (US, EU) Bydureon autoinjector - type-2 diabetes (EU)
Bevespi - COPD (EU)
Regulatory submission Lynparza - breast cancer (EU) Lynparza - ovarian cancer 1L Lynparza
Imfinzi +/- treme - lung cancer 3L (ARCTIC) Imfinzi + treme - lung cancer 1L (NEPTUNE) - pancreatic cancer
Imfinzi +/- treme - ovarian cancer 3L
Bevespi - COPD (JP) - lung cancer 1L (MYSTIC) Imfinzi +/- treme
Duaklir - COPD (US) - head & neck cancer 1L (KESTREL) - lung cancer 1L (POSEIDON)
- head & neck cancer 2L (EAGLE) - small-cell lung cancer (CASPIAN)
selumetinib - thyroid cancer - bladder cancer 1L (DANUBE)
roxadustat - anaemia (US) Brilinta - CAD2/type-2 diabetes CVOT
Farxiga - type-2 diabetes CVOT (DECLARE)
PT010 - COPD
Fasenra - COPD
anifrolumab - lupus
Key Phase III data Lynparza - ovarian cancer 1L Lynparza - pancreatic cancer Lynparza - ovarian cancer 3L
Imfinzi +/- treme Imfinzi + treme - lung cancer 1L (NEPTUNE) Imfinzi - lung cancer (PACIFIC) (final OS)
readouts - lung cancer 3L (ARCTIC) Imfinzi +/- treme
- lung cancer 1L (MYSTIC) (final OS) Farxiga - type-2 diabetes CVOT1 (DECLARE) - lung cancer 1L (POSEIDON)
- head & neck cancer 1L (KESTREL) - small-cell lung cancer (CASPIAN)
- head & neck cancer 2L (EAGLE) Fasenra - COPD - bladder cancer 1L (DANUBE)
selumetinib - thyroid cancer Calquence - chronic lymphocytic leukaemia
1. Cardiovascular outcomes trial. anifrolumab - lupus
2. Coronary artery disease. PT010 - COPD Brilinta - CAD/type-2 diabetes CVOT
Status as of 2 February 2018. Farxiga - Heart failure
35 lanabecestat - Alzheimer’s diseaseAgenda
Overview
Growth Platforms
Pancreatic beta cells at different
stages of regeneration: AstraZeneca
is investing in research that could
Oncology stimulate the regeneration of beta
cells in the pancreas with the aim of
stopping the progression of, or
reversing, the course of diabetes.
Finance
Pipeline and news flow
Closing and Q&A
36Pipeline-driven transformation A new AstraZeneca emerging FY 2017 • Financials delivered and momentum in Product Sales • Unprecedented pipeline news flow Commercial execution • Strong Lynparza, Tagrisso growth, Imfinzi emerging and Calquence launched • Brilinta and Farxiga became blockbusters • Fasenra launched in the US, with recent EU and JP approvals • China had strongest-ever growth in Q4 Guidance: FY 2018 • A low single-digit percentage increase in Product Sales • Core EPS of $3.30 to $3.50 Guidance at CER. 37
Q&A
Pipeline-driven transformation A new AstraZeneca emerging FY 2017 • Financials delivered and momentum in Product Sales • Unprecedented pipeline news flow Commercial execution • Strong Lynparza, Tagrisso growth, Imfinzi emerging and Calquence launched • Brilinta and Farxiga became blockbusters • Fasenra launched in the US, with recent EU and JP approvals • China had strongest-ever growth in Q4 Guidance: FY 2018 • A low single-digit percentage increase in Product Sales • Core EPS of $3.30 to $3.50 39
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40Full-Year and Q4 2017 Results Live presentation, conference call and webcast for investors and analysts 2 February 2018
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