astrazeneca q4 and full year 2014 results · great progress in 2015 achieve scientific leadership...
TRANSCRIPT
AstraZeneca
16 March 2016CFA Society, South Florida Chapter
Mitchell Chan, Director, Investor Relations
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
3
Agenda
Overview & Strategy
Financials
Pipeline
Closing
AstraZeneca: History of innovation What science can do
4
200320011997 200619991913 1993
Founded Founded Merger
2005
Acquisition
2007
Acquisition
2013
Acquisition
2011 2012
Acquisition
1948
Our journey continuesOn track to deliver long-term goals
5
>$45bn1
in 2023
2012-2014Building strong
foundations
2018+Sustainable delivery
and growth
2015-2017Delivering on return
to growth
1. Target is at constant exchange rates (2013) which is equivalent to ~$40bn at today’s exchange rates
6
Three Strategic PrioritiesGreat progress in 2015
Achieve scientific leadership Return to growth Be a great place to work
6 approvals of NMEs or major
LCM projects in major markets
2 Phase III NME starts
12 NME or major LCM
regulatory submissions in major
markets
2 Accelerated reviews included
3 FDA granted Fast Track
1% increase in Total Revenue
to $24,708 million at CER
11% increase in Growth
Platforms revenue contributing
57% of Total Revenue
Respiratory up 7%
Brilinta/Brilique: up 44%
Diabetes up 26%
Emerging Markets up 12%
Japan revenue up 4%
New Oncology contributed
$119 million
Our quarterly employee survey
showed belief in our strategy
stood at 89% vs 86% in 2014
Exceeded our targets for senior
leaders women (42% versus
41%) and country of origin from
an Emerging Market or Japan
(15.6% versus 13%)
Exceeded our target by
screening more than one
million people in Kenya for
hypertension as part of our
Healthy Heart Africa
programme
Capabilities across key technology platforms
7
Focus on three main therapy areas
Neuroscience
Infection &
Vaccines
Respiratory,
Inflammation &
AutoimmunityOncology
TAs
Cardiovascular &
Metabolic Disease
Opportunity-driven
Protein
engineeringBiologics
Small
molecules Immuno-therapies Devices
Personalised healthcare capabilities
Commitment to further focus the portfolio
Be a Great Place to Work
NEW Global R&D Centre &
Corporate Headquarter
Gothenburg, Sweden Gaithersburg, USACambridge, UK
Strategic R&D Centre Strategic R&D Centre
Specialty Products Group
8
61,500employees
worldwide
8,900employees in
R&D
12,500employees in
Manufacturing and Supply
9
R&D productivity increase
2015 2016 2017 2018
Unlocking pipeline valuePublications
Delivering sustainable R&D productivity improvements
2015 2010
552
2010
High-impact publications
Low-impact publications
Medium-impact publications
2015
397
Pip
eli
ne v
alu
e u
nlo
ck
ed
NME & major LCM submissions
Phase III / Registration NMEs
2010 2011 2012 2013 2014 2015
Phase III
Registration
7 76
11
13
15
Reflects expected regulatory submissions of key NMEsand major lifecycle management programmes
High-impact (rating > 15); medium-impact (rating > 5); low-impact (rating < 5) Reflects Phase III / Registration volumes at year-end
Pipeline value
unlocked
Externalisation Revenue and portfolio streamlining as a result
10
R&D productivity & focus provide new opportunities
All opportunities
Inline products
(Portfolio outside
main therapy areas)
Pipeline molecules
(R&D productivity)
Increasing valuee.g. Caprelsa
disposale.g. brodalumab
partnership
Focus on main therapy areas
Product Sales
Cardiovascular
& Metabolic
Disease
Externalisation
RevenueOther Operating
Income
- milestone(s)
- royalties- one-time
payment
Financials
• Total Revenue $24.7bn, +1%
– Growth Platforms: Now 57% of total1, +11%
• Core R&D investment underpinned by
– Core Gross Margin on Product Sales up by 1% point
– Core SG&A cost reduction of 2% and 11% in Q4
– Externalisation Revenue ~$1b; Other Operating Income ~$1.5bn
• Core EPS $4.26, +7%; +22% in Q4 2015
• Commitment to the progressive dividend policy
– Annual dividend of $2.80 per ordinary share
• 2016 Guidance (CER)
– Total Revenue: A low to mid single-digit percent decline
– Core EPS: A low to mid single-digit percent decline
• Future capital-allocation priorities outlined
12
2015: Financial highlights
1. As a percentage of Total Revenue and includes New Oncology as a sixth Growth PlatformAbsolute values at actual exchange rates. Growth rates at CER
FY 2015
$m
%
change
% Total
Revenue
Q4 2015
$m
%
change
Total Revenue 24,708 +1 100 6,399 +2
Product Sales 23,641 (1) 96 6,207 -
Externalisation Revenue 1,067 +140 4 192 +490
Core Cost of Sales (4,119) (6) 17 (1,209) +3
Core Gross Profit 20,589 +2 831 5,190 +2
Core R&D (5,603) +21 23 (1,567) +21
Core SG&A (9,265) (2) 37 (2,461) (11)
Core Tax Rate 16% - - 14% 3% points
Core EPS $4.26 +7 $0.94 +22
Leveraging top-line resilience
13
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
Building a durable presence in Emerging Markets 3rd fastest-growing pharma MNC
North America
40% of sales
Europe
23% of sales
Rest of World
Established
(ex-Japan)
4% of sales
Japan
9% of sales
Emerging Markets
(ex-China)
14% of sales
China
11% of sales
14
0
3
6
2013 2014 2015
Core R&D investment
Oncology CVMD RIA ING & Other
15
R&D investment underpinned by strong Core Gross Profit
• Manufacturing efficiencies
• Focus on supply chain
• Evolving mix of Product Sales from pipeline
29% 37%42%
29%
28%
32%24%
23%
19%
• Increasing focus on main therapy areas
• Oncology now enjoys the largest share
FY 2016 Core R&D costs are expected
to be at a similar level to FY 2015
based on constant exchange rates
Up-weighted 2015
investment in R&D
Absolute values at actual exchange rates. Growth rates at CER. Gross profit and margin here exclude the impact from Externalisation Revenue
82.0%81.3% 82.6%
$bn
10
15
20
2013 2014 2015
Core Gross Profit & Margin
$bn
2015 Core SG&A cost reduction delivered
• The Company is committed to materially
reducing Core SG&A costs in FY 2016 based
on constant exchange rates
• Productivity programmes and progress
– reducing third-party spend
– optimising functions and processes
– sales and marketing effectiveness
16
Continued focus on Core SG&A reduction
Core SG&A commitment renewed
-0.5
0.5
1.5
2.5
3.5
Q12014
Q22014
Q32014
Q42014
Q12015
Q22015
Q32015
Q42015
$bn SM&M
G&A
% of Total Revenue
FY 2014: 38.5%
FY 2015: 37.5%
~$1bn decline
FY Core
SG&A
(2)%
FY Core
SG&A
ratio
(1)%
Absolute values at actual exchange rates. Growth rates at CER
100
110
120
130
140
150
160
170
180
190
200
31/12/2012 31/12/2013 31/12/2014 31/12/2015
AZN FTSE 100
AstraZeneca has outperformed the largest FTSE 100 companies1
Total Shareholder Return (TSR) since 1 January 2013
Index TSR AstraZeneca vs. FTSE 100
+83%
+18%
17
1 TSR between 1 Jan 2013 and 31 Dec 2015. Source: DatastreamRanking includes the 15 companies with the highest weightings of the FTSE 100 index as per 1 January 2013. Source: Bloomberg
Pipeline
19
2015: Delivering the late-stage pipeline
A great year for patients and science
Iressa
approval (US)
Faslodex 500mg
approval (CN)
saxa/dapa
submission (EU)
cediranib
submission (EU)
CAZ AVI
submission (EU)
selumitinib
Phase III endpoint not met
(uveal melanoma)
saxa/dapa
Complete Response
Letter (US)
PT003
- Phase III readout
- submission (US)
Tagrisso
- submission
- CHMP (EU)
- approval (US)
Brilinta/Brilique
- Phase III PEGASUS
- approval (US)
- CHMP (EU)
- ACS, post-MI
submission (JP)
Zurampic
- submission
- CHMP (EU)
- approval (US)
brodalumab
submission (US, EU)
ZS-9
submission (EU)
Bydureon Pen
approval (JP)
20
Several products in the pipeline have large potential
durva + tremeMultiple cancers
benralizumabSevere asthma, COPD
roxadustatAnaemia
anifrolumabLupus (SLE)
TagrissoLung cancer
LynparzaOvarian, other cancers
ZS-9Hyperkalaemia
acalabrutinibBlood cancers
PT010COPD, asthma
21
AZ Oncology: Scientific leadership in four key platforms Personalised healthcare as key driver
Four disease areas with first or best-in-class cornerstone medicines
Tagrisso,
Iressa, acalabrutinib
Lynparza,
WEE-1, ATR, ATM
Durvalumab,
I/O Combinations
Moxetumomab,
ADC
Immuno-Oncology
Tumor drivers
and resistance
Antibody
conjugates
DNA damage
response
Immuno-
oncology
Tagrisso exemplifies progress being made
Innovative therapy with large potential
22
• First treatment approved for patients with a very
specific form of NSCLC
• Fastest development journey in the company’s
history: 32 months from first-in-man to approval
• Fastest shipment time: 6 hours from approval
• Reinforces ambition in Oncology to deliver six new
medicines to patients by 2020
United States: 3k
EU5: 3k
Japan: 8k
United States: 12k
EU5: 9k
Japan: 18k
United States: 4k
EU5: 3k
Japan: 8k
14kPatients
treated
Adjuvant
1st line
2nd line (T790M)
15kPatients
treated
39kPatients
treated
EG
FR
m N
SC
LC
23
AcalabrutinibSecond-generation BTKi with best-in-class potential
• Long duration of treatment
• Maintaining response requires continuous dosing
• Interruptions or dose reductions can lead to fast
disease progression or resistance
• In NHL, combinations are needed for superior
efficacy and tolerability is critical
Tolerability
issues
Atrial
fibrillation
Rash
Myalgia
(muscle pain)
BruisingArthralgia
(joint pain)
Bleeding
Source: Jain, P. (2015). Outcomes of patients with chronic lymphocytic leukemia after discontinuing ibrutinib. Blood. 125(13):2062-2067
Maddocks, K.J. (2014). Etiology of Ibrutinib Therapy Discontinuation and Outcomes in Patients With Chronic Lymphocytic Leukemia. JAMA. Oncol.doi:10.1001/jamaoncol.2014.218
Farooqui, M. (2015). Atrial Fibrillation in CLL/SLL Patients on Ibrutinib; ASH Abstract# 2933
24
Haematology: Significant growth market in OncologyAccounts for ~1/3 of total Oncology market
Overall market size
Note: Chart data exclude sales of medicines used for supportive care in oncology
Source: Decision Resources, EvaluatePharma, Datamonitor, company reported sales, and IMS
2012
$64bn
2023
$140bn-$150bn
0
10
20
30
40
50
Heme Breast Prostate Lung Ovarian RoM
2012 2023CAGR
2012-20237% 6% 9% 6% 12% 6%
Market projections
($ billion)
~40
20+
1220+
3-5
43
Projected G7 CLL market
53%
23%
23%
1%
Antibodies Chemo TKIs Steroids
2014
$1.8bn
12%2%
84%
<1% 1%
2024
$10.6bn
Source: Decision Resources, NHL, November 2015
CLL=Chronic Lymphocytic Leukaemia
Immunomodulators
25
Lynparza: Backbone in ovarian cancer
Step one
Step two
Step three
Step four
Establish Lynparza as
standard of care in HRD
Expand beyond HRD
with VEGFi combos
Displace chemo in 2L
Enhance efficacy
across segments
through double
combos
Displace chemo in 1L
with triple combos
Lynparza backbone
Lynparza + WEE1 combos
Lynparza + VEGFi combos
WEE1 mono
Lynparza + durvalumab
Lynparza + durvalumab
+ WEE1
Breakthrough
Designation
for Prostate Cancer
26
DNA Damage Response (DDR) Emerging evidence show potentials for cure
AZD0156
(ATM)
AZD6738
(ATR)
1. Maximise
Damage
2. Prevent
Repair Lynparza
(PARP)
AZD1775
(Wee1)
3. Death in
Mitosis
AZD2811
(AurB)
1. Identify tumour
DDR abrogations
2. Identify the
corresponding
DDR
dependencies
3. Exploit DDR
dependencies with
the right DDR
agent or
combination of
agents
Combinations with Durvalumab
27
AstraZeneca IO Targets in Clinical Development
Antigen presentation &
Innate immunity
Vaccines
(Advaxis HPV*, IMCgp100,
IMMTAC)
Oncolytic Virus*
(Omnis VSV-Ifnb)
HER2 Bispecific
ADCTLR 7/8
NKG2A*
Optimising T-cell function and memory
OX40 FP
OX40 hAbNME-2015
PD-L1
PD-1
CTLA-4
CART*
Inhibition by micro-
environment
CCR4*
CXCR2
P-tydylSerineIDO*
STAT3
Chemo
Radiotherapy
*Clinical collaboration
ITK* GITR
IMMTAC*
CXCR4*
p110d* CSF-1R* TGFb*
VEGF* CD73
HDAC IMiD
Greatest unmet medical need is in PD-L1 negative tumours
28
IO: Clinical activity in lung cancer
IO combinations address major unmet medical need:
PD-L1 negative tumours in lung cancer
Source: Internal estimates based on market research. *PD-L1 positive: Patients with moderate/high level of PD-L1 expression; represent ~30%. **PD-L1 negative: Patients with low level of PD-L1 expression or no PD-L1 expression; represent ~70%. Note: Patient number estimates in 2020. EGFRm: 14%, ALKm: 5%
60-70% of patients below
10% PD-L1 expression level
Source: Borghaei, H. (2015). Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. NEJM, 373, 1627-39.
Nivolumab
MutationSCLC
70k pts
PD-L1 positive*(80k pts)
PD-L1 negative** (186k pts)
EGFR/ALK WT
266k ptsEGFRm
48k pts
ALKm
18k pts
Mono
Combo
Combo
NSCLC SCLCP
D-L
1 s
tatu
s
Com
bo
Ire
ssa
/ co
mb
ina
tio
ns
Time (months)
Overall survival
--
Target two different escape pathways
29
IO: Combination of Durva + Treme
MYSTIC data readout in H1 2017
30
Key pipeline newsflow
H1 2016
• benralizumab - severe asthma
• Brilinta/Brilique - stroke
• Lynparza - gastric cancer
H2 2016
• Brilinta/Brilique - PAD2
• Lynparza - ovarian, breast cancers
• durvalumab - H&N cancer
• acalabrutinib - blood cancer
• selumetinib - lung cancer
Key data readouts
2. Peripheral Arterial Disease
H1 2016
• Brilinta/Brilique - stroke
• saxa/dapa - type-2 diabetes (US)
H2 2016
• benralizumab - severe asthma
(US, EU)
• roxadustat - anaemia (CN)1
• acalabrutinib - blood cancer (US)
Key regulatory submissions
H1 2016
• Zurampic - gout (EU)
• PT003 - COPD (US)
• ZS-9 - hyperkalaemia (US)
• Tagrisso - lung cancer (JP)
H2 2016
• saxa/dapa - type-2 diabetes (EU)
• cediranib - ovarian cancer (EU)
• CAZ AVI - serious infections (EU)
Regulatory decisions
1. Rolling regulatory submission
Closing
Key messages
32
Strategy implementation on track - started second phase of the Journey
Late-stage pipeline progressing ahead of plans
• Science-driven, collaborative culture driving increased R&D productivity
• Steady newsflow expected in 2016
Accelerating return to growth and ambition to become a >$45bn company by 20231
Building a sustainable, durable and more profitable business
• Highest TSR (January 2013 to today) of large-cap FTSE 100
1. Target is at constant exchange rates (2013) which is equivalent to ~$40bn at today’s exchange rates
AstraZeneca
16 March 2016CFA Society, South Florida Chapter
Mitchell Chan, Director, Investor Relations
34
Key late-stage new medicines and lifecycle programmes
Respiratory, Inflammation
& Autoimmunity
Phase III
anifrolumab
IFNAR
Lupus (SLE)
PT010
LAMA/LABA/ICS
COPD
benralizumab
IL-5R
Severe asthma, COPD
brodalumab
IL-17R
Psoriasis
tralokinumab
IL-13
Severe asthma
PT003
LAMA/LABA
COPD
Zurampic
URAT-1
Gout
roxadustat
HIF-PH
Anaemia CKD/ESRD
durvalumab
PD-L1
3L PD-L1 pos. NSCLC
moxetumomab
CD22
HCL
selumetinib
MEK
2L KRASm NSCLC
cediranib
VEGF
PSR ovarian cancer
Other
CAZ AVI
Cephalosporin/BLI
Serious infections
Tagrisso (EU, JP)
EGFR T790M
2L T790Mm NSCLC
Cardiovascular &
Metabolic DiseaseOncology
Under review Phase III Under review Phase III Under review
ZS-9
Potassium binder
Hyperkalaemia
Under review
Brilinta/Brilique
P2Y12
Stroke
Additional uses
Brilinta/Brilique
P2Y12
Peripheral Arterial Disease
Lynparza
PARP
Various indications
Additional uses
Tagrisso
EGFR T790M
Various indications
acalabrutinib
BTKi
Blood cancer
35
Full pipeline of new medicines (NMEs)OncologyRIA CVMD Infection, Neuroscience, Gastrointestinal
1 Includes significant fixed dose combination projects, and parallel indications that are in a separate therapeutic area (See LCM
chart for other parallel indications and oncology combination projects)
# Partnered and/or in collaboration; ¶ Registrational P2/3 study; ψ Completion of the agreement with Acerta Pharma Q1 2016† MEDI-550 does not count toward late-stage NME totals (submitted to EMEA December 2015)
Biotech units: Driving the ‘next wave’ of innovation
36
“Next-wave”
delivery
Around 30 projects
currently in Phase I will
deliver “next wave” of
molecules to late stage
Long-term
sustainability
Advancing potentially
transformative platforms
such as oligonucleotides,
novel proteins, cancer
vaccines and stem cells
Leveraging protein
engineering capabilities for
novel approaches
Planned R&D Centre and Corporate
HQ building
Scientific collaboration is a key driver behind the move
Cambridge UK research centre catalyst for innovation
37
Addenbrooke’s Hospital
The Rosie Hospital
School of Clinical
Medicine
Future hospital site
Cambridge Institute
Laboratory of
Molecular Biology
Site of planned Energy Centre
and R&D Enabling Building
38
14,400Employees in
North America
(23%)
A Global Business61,500 employees in over 100 countries
3,400Employees in
Central and South America
(6%)
20,100Employees in Europe
(excluding Russia)
(33%)
1,700Employees in
Middle East and Africa
(3%)
1,400Employees in
Russia
(2%)
6,500Employees in
Asia Pacific
(excluding China, Japan, and Russia)
(10%)
3,000Employees in
Japan
(5%)
11,000Employees in
China
(5%)Co-locating around 3
strategic R&D centres• Cambridge, UK
(1,600 employees)
• Gaithersburg, Maryland US
(2,900 employees)
• Gothenburg, Sweden
(2,200 employees)