a focused biopharmaceutical company - astrazeneca.com prsn... · north america $185-215bn growth...
TRANSCRIPT
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 other things, statements about expected revenues, margins, earnings per share or other financial or other measures. Although we believe our expectations arebased on reasonable assumptions, any forward-looking statements, by their very nature, involve risks and uncertainties and may be influenced by factors that couldcause actual outcomes and results to be materially different from those predicted. The forward-looking statements reflect knowledge and information available at thedate of preparation of this document and AstraZeneca undertakes no obligation to update these forward-looking statements. We identify the forward-lookingstatements by using the words 'anticipates', 'believes', 'expects', 'intends' and similar expressions in such statements. Important factors that could cause actual resultsto 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 IPrights; 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 orservices; the risk of failure of outsourcing; the risks associated with manufacturing biologics; the risk that R&D will not yield new products that achieve commercialsuccess; 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, includinglicensing and collaborations, will be unsuccessful; the risks from pressures resulting from generic competition; the impact of competition, price controls and pricereductions; the risks associated with developing our business in emerging markets; the risk of illegal trade in our products; the difficulties of obtaining and maintainingregulatory approvals for products; the risk that regulatory approval processes for biosimilars could have an adverse effect on future commercial prospects; the risk offailure to successfully implement planned cost reduction measures through productivity initiatives and restructuring programmes; the risk of failure of critical processesaffecting business continuity; economic, regulatory and political pressures to limit or reduce the cost of our products; failure to achieve strategic priorities or to meettargets or expectations; the risk of substantial adverse litigation/government investigation claims and insufficient insurance coverage; the risk of substantial productliability claims; 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 toanti-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 environmentalliabilities; 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 tosuccessfully engage with our employees; the risk of misuse of social medial platforms and new technology; and the risk of failure of information technology andcybercrime. Nothing in this presentation / webcast should be construed as a profit forecast.
2
Forward-looking statements
Three therapy areas
5
Focused strategy
RespiratoryCardiovascular, Renal & MetabolismOncology
Commitment to further focus the portfolio
A new AstraZeneca with science-based culture
6
R&D productivity: Sustainable progress
Source: Internal analysis. High-impact (rating > 15); medium-impact (rating > 5); other (rating < 5).
AstraZeneca (AZN) and industry peers/competitors (CP) 1-7.Source: Internal analysis based on focr.org. Includes Breakthrough TherapyDesignations (BTD) in the three main AstraZeneca therapy areas.
FDA BTDs granted in AZN’s main therapy areas 2016-2017
Scientific publicationsHigh-impact publications
Other publicationsMedium-impact publications
5 5 5
4
2 2 2 2
Sustainable level of potential new medicines in Phase II trials
1,054
397
27
3533
3634
OncologyRespiratory
CVRMOther
Unprecedented activity level in ‘17
7
Late-stage pipeline news flow
Tagrissolung cancer (AURA3)Full approval (US, EU)
Forxigatype-2 diabetesApproval (CN)
Qterntype-2 diabetesApproval (US)
Tagrissolung cancer
Approval (CN)
Siliqpsoriasis
Approval (US, by partner)
Lynparzabreast cancer
Phase III positive
Farxigatype-2 diabetes
CVD-REAL study
inebilizumabneuromyelitis opticaspectrum disorder
Orphan designation (EU)
Lynparzaovarian cancerOrphan Drug
designation (JP)
Imfinzibladder cancerApproval (US)
Faslodexbreast cancer 1LApproval (EU, JP)
Kyntheumpsoriasis
Approval (EU, by partner)
Imfinzilung cancer (PACIFIC)
Phase III positive (PFS3)
Bydureontype-2 diabetes (CVOT)
Phase III met primary safety objective; did not meet primary
efficacy objective
Imfinzilung cancer (MYSTIC)
Phase III negative (PFS)
Faslodexbreast cancerApproval (US)
Lynparzaovarian cancer 2L, 4L/tablets
Approval (US)
Calquencemantle cell lymphoma
Approval (US)
Briliqueprior myocardial infarction
Approval (CN)
Farxiga + Bydureontype-2 diabetes
Approval (US, EU)
Bydureon BCisetype-2 diabetes autoinjector
Approval (US)
SymbicortCOPD exacerbations
Approval (US)
tralokinumabsevere, uncontrolled asthma
Phase IIIs negative
Tagrissolung cancer (FLAURA)
Phase III positive
moxetumomabhairy cell leukaemiaPhase IIIs positive
DuaklirCOPD
Phase III positive
Tagrissolung cancer (FLAURA)Breakthrough Therapy
Designation (US)
Imfinzilung cancer (PACIFIC)Breakthrough Therapy
Designation (US)
roxadustatanaemia
Completed reg. submission (CN, by partner)
tezepelumabsevere, uncontrolled
asthmaPhase IIb positive
Farxigatype-1 diabetes
Phase IIIs positive
Calquencemantle cell lymphomaBreakthrough Therapy
Designation (US)
Lynparzaovarian cancer 2LReg. submission
(EU, JP)
Lynparzabreast cancer
Reg. submission (US, JP)
ZS-9hyperkalaemia
Complete Response (US)
ZS-9hyperkalaemia
CHMP1 opinion (EU)
Imfinzilung cancer (PACIFIC)
Reg. submission (US, EU, JP)
BevespiCOPD2
Reg. submission (EU)
Bydureon BCisetype-2 diabetes autoinjector
Reg. submission (EU)
Fasenrasevere, uncontrolled asthma
CHMP opinion (EU)
Fasenrasevere, uncontrolled asthma
Approval (US)
Significant patient benefits anticipated to support return to growthRegulatory actions
Data & designations
Tagrissolung cancer (FLAURA)
Reg. submission (EU, JP)
1. The Committee for Medicinal Products for Human Use.2. Chronic obstructive pulmonary disease.1. Progression-free survival.Status as of 14 December 2017. Favourable / unfavourable news.
benralizumabsevere, uncontrolled asthmaRegulatory submission (JP)
Significant opportunities exist in all three therapy areas
8
Late-stage pipeline and key lifecycle medicines
1. Lifecycle development programme.2. Under regulatory review in major jurisdiction.Status as of 20 June 2018.
Oncology Cardiovascular,Renal & Metabolism Respiratory
Lynparza1, 2
multiple cancersroxadustat2
anaemiaPT010
COPD / asthma
Tagrisso1, 2
lung cancertezepelumab
severe, uncontrolled asthma
Imfinzi1, 2
multiple cancers
Calquence1
blood cancers Other
moxetumomab pasudotox2
leukaemiaanifrolumab
lupus
tremelimumabmultiple cancers
selumetinibthyroid cancer
savolitinibkidney cancer
9
Full pipeline of new medicines (NMEs)
Status as of 18 May 2018.
1 Includes significant fixed-dose combination projects, and parallel indications that are in a separate therapy area.# Partnered and/or in collaboration; ¶ Registrational Phase II/III study.
Oncology RespiratoryCardiovascular, Renal & Metabolism Other
Phase I Phase II Phase III31 New Molecular Entities 21 New Molecular Entities 8 New Molecular Entities
Small molecule Small molecule Small moleculeLarge molecule Large molecule Large molecule
Applications Under Review2 New Molecular Entities
Large moleculeSmall molecule
AZD0156ATM solid tumours
AZD1390ATM healthy volunteer study
AZD2811#Aurora solid tumours
AZD4573CDK9 hematalogical malignancies
AZD4635A2aR inhibitor solid tumours
AZD4785KRAS solid tumours
AZD5153BRD4 solid tumours
AZD5991MCL1 hematalogical malignancies
AZD6738ATR solid tumours
AZD8186PI3Kβ solid tumours
AZD9496SERD ER+ breast
MEDI0562#hOX40 solid tumours
MEDI1873GITR solid tumours
MEDI3726#PSMA prostate
MEDI4276HER2 solid tumours
MEDI5083CD40 ligand fusion protein solid tumours
MEDI7247antibody drug conjugate haems
MEDI9197#TLR 7/8 solid tumours
oleclumabCD73 solid tumours
adavosertib# (AZD1775)+chemotherapyWee1+chemo ovarian cancer
AZD4547FGFR solid tumours
capivasertib (AZD5363)#AKT breast cancer
vistusertibmTOR 1/2 solid tumours
Imfinzi#+tremelimumab MYSTICPD-L1+CTLA-4 1L NSCLC
Lynparza¶+cediranib CONCERTOPARP+VEGF recurrent Pt-R ovarian
savolitinib# SAVOIRMET pRCC
selumetinib ASTRAMEK differentiated thyroid cancer
moxetumomab pasudotox# PLAITCD22 3L HCL
MEDI7219anti-diabetic type-2 diabetes
AZD5718FLAP coronary artery disease
AZD8601#VEGF-A cardiovascular
MEDI0382GLP-1/glucagon type-2 diabetes
MEDI5884#cholesterol modulation cardiovascular
MEDI6012LCAT cardiovascular
verinuradURAT-1 chronic kidney disease
roxadustat# HIFPH anaemia CKD/ESRD
MEDI3506IL-33 COPD
abediterol#LABA asthma/COPD
AZD1419#inhaled TLR9 asthma
AZD7594Inhaled SGRM asthma/COPD
AZD7986#DPP1 COPD
AZD8871#MABA COPD
AZD9567SGRM RA/respiratory
tezepelumab# NAVIGATOR SOURCETSLP severe uncontrolled asthma
MEDI0700#BAFF/B7RP1 SLE
MEDI1341alpha synuclein parkinson's disease
MEDI1814#amyloidβ alzheimer's disease
MEDI7352NGF/TNF osteoarthritis pain
MEDI3902Psl/PcrV Pseudomonas pneumonia
MEDI8852influenza A treatment
MEDI8897#passive RSV prophylaxis
prezalumab#primary Sjögren’s syndrome
suvratoxumabα-Toxin Staphylococcus pneumonia
anifrolumab# TULIPType I IFN receptor SLE
AZD4831MPO HFpEF
AZD9977MCR cardiovascular
AZD1402#inhaled IL-4Ra asthma
AZD5634inhaled ENaC cystic fibrosis
AZD7594+abediterol#Inhaled SGRM+LABA asthma/COPD
AZD0284RORg psoriasis/respiratory
lanabecestat#BACE early alzheimer's disease
PT010LABA/LAMA/ICS COPD
Unlocking and realising potential of new medicine
10
Late-stage pipeline news flow 2018 & 2019
Q2 2018 H2 2018 2019Regulatory decision Tagrisso - lung cancer (EU)
Lokelma - hyperkalaemia (US)Lynparza - breast cancer (JP)Tagrisso - lung cancer (JP)Imfinzi - lung cancer (PACIFIC) (EU, JP)moxetumomab pasudotox - HCL 3L (US)Bydureon autoinjector - type-2 diabetes (EU)Bevespi - COPD (EU)
Lynparza - breast cancer (EU)
Regulatory submission Duaklir - COPD (US) Bevespi - COPD (JP)Lynparza - ovarian cancer 1LImfinzi +/- treme- lung cancer (MYSTIC) - head & neck cancer 2L (EAGLE)selumetinib - thyroid cancer
PT010 - COPDFasenra - COPD
Lynparza - pancreatic cancerImfinzi + treme - lung cancer 1L (NEPTUNE)Imfinzi +/- treme- lung cancer (POSEIDON)- small-cell lung cancer (CASPIAN)- bladder cancer 1L (DANUBE)- head & neck cancer 1L (KESTREL)Calquence - chronic lymphocytic leukaemiaBrilinta - CAD2/type-2 diabetes CVOTFarxiga - type-2 diabetes CVOT (DECLARE)roxadustat - anaemia (US)anifrolumab - lupus
Key Phase III data readouts
Lynparza - ovarian cancer 1L
Fasenra - COPD (TERRANOVA)
Imfinzi +/- treme- lung cancer (MYSTIC) (final OS)- head & neck cancer 2L (EAGLE)- head & neck cancer 1L (KESTREL)selumetinib - thyroid cancer
Farxiga - type-2 diabetes CVOT1 (DECLARE)roxadustat - anaemia
anifrolumab - lupus
Lynparza - pancreatic cancerImfinzi - lung cancer (PACIFIC) (final OS)Imfinzi + treme - lung cancer 1L (NEPTUNE)Imfinzi +/- treme- lung cancer (POSEIDON)- small-cell lung cancer (CASPIAN)- bladder cancer 1L (DANUBE)Calquence - chronic lymphocytic leukaemiaBrilinta - CAD/type-2 diabetes CVOTFarxiga - heart failurelanabecestat - Alzheimer’s disease
1. Cardiovascular outcomes trial.2. Coronary artery disease.Status as of 18 May 2018.
Momentum to improve during the year
11
2018: return to growth on track
2018: low single-digit growth in Product Sales
Lynparzaongoing launch of tablet in ovarian and breast cancer
Tagrissoongoing launch in
1st-line lung cancer
Imfinziongoing launch in
unresect. sIII lung cancer
Brilintacontinued
global growth
Farxigacontinued global growthand the DECLARE trial
Crestorannualisation of
loss of exclusivity(EU, JP)
Fasenraongoing launch in
severe, uncontrolled asthma
Change (Product Sales growth) and 2018 guidance at CER.
Medicines that are impactingProduct Sales growth in 2018
Q1 impacted by Crestor EU/JP; divestmentsComparisons easing as the year progresses
FY 2010
FY 2011
FY 2012
FY 2013
FY 2014
FY 2015
FY 2016
Q1 2017
Q2 2017
Q3 2017
Q4 2017
Q1 2018
Prod
uct S
ales
gro
wth B
MS
D
iabe
tes
Alli
ance
Q1 2018 $m % change % Product
Sales
Product Sales 4,985 (2) 100
Oncology 1,230 33 25
New CVRM 900 8 18
Respiratory 1,181 (6) 24
Other 1,674 (19) 34
Emerging Markets 1,765 8 35
-of which China 1,025 22 21
Overall performance impacted by Crestor EU / JP, divestments
12
Product Sales: Oncology, China were the key drivers
Product Sales values at actual exchange rates; change at CER.
R&D productivity & focus drive decisions
13
Strategic value-creation framework
R&D productivityFocus on three main therapy
areas
‘Following the science’leads to innovationin and outside areas offocus
OncologyCVRM - Cardiovascular,Renal & MetabolismRespiratory
Externalisation1(milestones/royalty)
Accelerate/enhance value; or new medicines outside focus
Product Sales(Including Growth Platforms)
Other Operating Income2
Disposal, typically of legacy medicines outside focus
1. Medicines in which AstraZeneca maintains a significant future interest. Income through (recurring) milestones and royalty.2. One-off disposal income and legacy royalty income.
Geographic platform for growth
15
Emerging Markets
US31% ofProduct Sales
Europe24% of
Product Sales
Rest of World
Established(ex-Japan)
4% ofProduct Sales
Japan11% of
Product Sales
Emerging Markets
(ex-China)16% of
Product Sales
China15% of
Product Sales
2017 Product Sales as reported.
Primary care key to success
16
Emerging Markets
51%
49%Europe
$42-49bn growth
9%
91%AFME
$15-20bn growth
6%
94%
Latin America$20-25bn
growth
32%68%
North America$185-215bn
growth
40%60% World
$305-335bn growth
15%
85%
Asia$70-90bn
growth
Primary care
Specialty care
Share of absolute growth 2016-2021 by region, specialty and primary careSource: IMS Market Prognosis, September 2016; QuintilesIMS Institute, October 2016.Chart notes: Growth in US$ using constant exchange rates. Asia: China, India, Russia, CIS states, SE Asia, Oceania and Japan. AFME: Africa and Middle East.
Q1 2018$m % change % Total
Revenue
Total Revenue 5,178 (9) 100
- Product Sales 4,985 (2) 96
- Externalisation Revenue 193 (67) 4
Gross Margin 78.8% (4) pp -
Operating Expenses 3,349 (1) 65
- R&D Expenses 1,240 (12) 24
- SG&A Expenses 2,028 6 39
Other Operating Inc. & Exp. 124 (64) 2
Tax Rate 18% - -
EPS $0.48 (51) -
Absolute values at actual exchange rates; change at CER.Gross Margin reflects Gross Profit derived from Product Sales, divided by Product Sales.
17
Core Profit & Loss
As a company built on delivering positive health outcomes, sustainability underpins everything AstraZeneca does
19
Sustainability
• As we strive to reach 200 million patients by 2025, we are evolving our approach and in 2017 rolled out a roadmap that further embedded sustainability into the Company’s DNA
• This will ensure AstraZeneca effectively addresses the most fundamental issues for business, shareholders, society and the environment
20
Sustainability - recent highlights
Healthy Heart Africa Program: Over one million patients screened in 2015, exceeding its year-one target
Achieved a 21.2% cut in our greenhouse gas footprint from 2010 levels
Increased the number of senior managers who are women to 42%
100% of employees trained on Code of Conduct
#2 Overall in Pharmaceuticals, Biotechnology and Life Sciences industry group#1 in sector: Health Outcomes Contribution, Marketing Practices, Climate Strategy
Discovery, development and commercial structure
21
Great place to work
GlobalMedicines
Development Market
Innovative Medicines and Early Development Biotech Unit
(AstraZeneca Researchand Early Development)
MedImmune Biotech Unit(MedImmune Research and Early Development
Late-stagedevelopmentDiscovery and early development
Collaborations and combinations
Internal and external
opportunities
Commercial
GlobalPortfolio
&ProductStrategy
22
Great place to work
Headquarters
Gothenburg, Sweden Gaithersburg, USCambridge, UK
Strategic R&D Centre Strategic R&D Centre
Realising company vision
23
Great place to work
1. A passion for people development
6. Access to medicines & social responsibility
5. Environmental sustainability
4. Energising sites and workplaces
3. Flawless technologyand ways of working
2. Strong, supportive, leadership at all levels
Values and Purpose
• Financials on track• Product Sales as anticipated
– Strong execution of launches; offset by tail of Crestor EU/JP and divestments• Total Revenue impacted by lower Initial Externalisation Revenue• Core operating expenses declined by 1%
• Newer medicines delivered $0.4bn in additional sales vs. Q1 2017 and 66% growth• Lynparza, Tagrisso, Imfinzi all very strong• CVRM blockbusters Brilinta and Farxiga continued growth• Respiratory competitive, but Fasenra off to a rapid start• China maintained fast growth
• Pipeline continued to deliver important news flow
• 2018 guidance reiterated
Financials on track - commercial execution - guidance reiterated
25
Encouraging launches underpin 2018 return to growth
Absolute values, change and guidance all at CER.
26
On track: Long-term goals
>$45bn in 2023
2012-2014Building strong
foundations
2018+Sustainable delivery
and growth
2015-2017Delivering on return
to growth
Target is at constant exchange rates (2013) which is equivalent to ~$40bn at current exchange rates.
astrazeneca.com/investors
Thomas Kudsk LarsenCambridge, [email protected]: +44 20 3749 5712M: +44 7818 524185
Mitchell ChanWashington D.C., [email protected]+1 240 477 3771Toll free +1 866 381 7277
Nick StoneCambridge, [email protected]: +44 20 3749 5716 M: +44 7717 618834
Craig MarksCambridge, [email protected]: +44 20 3749 5714M: +44 7881 615764
Henry WheelerCambridge, [email protected]: +44 20 3749 5797M: +44 7788 354619
Christer GruvrisCambridge, [email protected]: +44 20 3749 5711 M: +44 7827 836825
27
Investor Relations
Use of AstraZeneca webcast, conference call and presentation slidesThe AstraZeneca webcast, conference call and presentation slides (together the ‘AstraZeneca Materials’) are for your personal, non-commercial use only. You may not copy, reproduce, republish, post, broadcast,transmit, make available to the public, sell or otherwise reuse or commercialise the AstraZeneca Materials in any way. You may not edit, alter, adapt or add to the AstraZeneca Materials in any way, nor combine theAstraZeneca Materials with any other material. You may not download or use the AstraZeneca Materials for the purpose of promoting, advertising, endorsing or implying any connection between you (or any thirdparty) and us, our agents or employees, or any contributors to the AstraZeneca Materials. You may not use the AstraZeneca Materials in any way that could bring our name or that of any Affiliate into disrepute orotherwise cause any loss or damage to us or any Affiliate. AstraZeneca PLC, 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, CB2 0AA. Telephone + 44 20 3749 5000, www.astrazeneca.com
Jen KretzmannCambridge, [email protected]: +44 xx xxxx xxxx M: +44 7469 408333