Beruflich Dokumente
Kultur Dokumente
February 2012
Contents
Page 1. Corporate Strategy 2. 2 FY 2011 Fi Financial P f i l Performance 3. FY 2011 Key Product Performance 4. 4 R&D U d t Update 5. Strategy update & Planning assumptions 2012+ 6. News fl 6 N flow 2011 7. AZN - Historic performance & Shareholder returns 8. Key industry 8 K i d t growth drivers th d i 9. Q4 Financial & Key Product Performance 10. Investor Relations contacts 10 I R l i 11. Appendices 3 7 15 45 81 99 101 106 124 136 139
Strategy
Industry outlook
Increasing and ageing populations Expanding populations in new markets Significant unmet medical need Continued scientific and technological advance
Growth Sector
Decline in R&D productivity p y Established market price pressure Patent expiries and genericisation
Increased R&D productivity opportunities Adapting sales and marketing model Further cost reduction potential Improved investment discipline
Our vision
AstraZeneca is
Focused Innovation-driven Integrated Global Biopharma
OUR VALUES
Strategy
Growth of current products Successfully launch the new products Drive growth in emerging markets Develop innovative p channels to meet customer needs
Implement asset strategy & LEAN Drive efficiencies in Sales & Marketing and G&A d Focus Capex on productivity improvements p
- Disease area focus - Reduce site footprint - Externalisation - Build stronger relationship l ti hi with payers
Collaboration
Strategy
Financial Performance
FY 2011 Summary
Financial performance
Revenue $33,591m (-2% CER) Reflects loss of nearly $2bn from generic competition & further $1bn lost to the impact from government price interventions Core EPS $7.28 (+7% CER) $7 28 Strong performance of Crestor, Symbicort, Seroquel XR
Shareholder returns
Dividend 2011 $2.80 (+10%) Net cash distributions to shareholders 2011 +71% to $9.4bn vs. 2010 through net share repurchases of $5.6bn & $3.8bn through the payment of the second interim dividend from 2010 and the first dividend from 2011
Other developments
Disposal of Astra Tech business to DENTSPLY for appro imatel $1.8bn in cash completed in August approximately $1 8bn A g st 2011. Net proceeds added to share repurchases
Financial Performance
Performance
Reported EPS
$7.33
$5.60
+31% 31%
+29% 29%
Financial Performance
Performance
Financial Performance
Performance
10 10
Crestor Seroquel
Seroquel IR Seroquel XR
+13% +8%
+3% +27%
Nexium Symbicort
4,429 3,148
Financial Performance
Performance
11 11
Financial Performance
Performance
12 12
Financial Performance
Performance
* Adjusted for Tax settlements, ** Including $1483 million from AstraTech disposal
13 13
Net cash from operating activities Net capex Astra Tech Disposal Proceeds Dividends/Net share buy-back Other movements Closing net cash/(debt) Gross debt Cash/Cash equivalents and STIs
Financial Performance
Performance
14 14
Product Performance
Crestor
FY 2011 Sales: $6,622m +13% CER
EM ROW $661m +8% EST ROW $1,662m +15% W. EUR $1,225m +5%
Global volume growth 2x statin market (12% vs 6%) Crestor US TRx +4% - Statin market +1% - Generic atorvastatin launched end November - Crestor TRx volume stable 5% Western Europe sales +5% Double-digit growth in France and Spain Established ROW sales +15% Japan accounts for half of the increase Emerging Markets sales +8% Good growth in Emerging Europe & China Generics in Brazil
US $3,074m +16%
W EUR EM ROW
16 16
500,000
+2% / +2%
400,000
Pre/Post
200,000
+6% / +1%
100,000
**
TRx
NRx
NBRx
Product Performance
* Source: IMS NPA Market Dynamics, Data Week ending 01/20/12 (TRx, NRx) ** Source: IMS NPA Market Dynamics, Data Week ending 01/13/12 (NBRx)
17 17
Crestor: STELLAR study LDL-C lowering across the dose range LDL C l i th d
LDL-C: LS mean change from baseline at week 6
0 -5 -10 -15 20 -25
10 mg
-30
-35
-40
-45
-50
20 mg
-55
40 mg
-60 CRESTOR
20 mg ^^^ 80 mg ^^^
40 mg ^^^
80 mg
Atorvastatin
Simvastatin
Pravastatin
CRESTOR 10mg 10 (-46%)
DATA ON FILE
Product Performance
*p<0.002 vs atorvastatin 10 mg; simvastatin 10, 20, 40 mg; pravastatin 10, 20, 40 mg p<0.002 vs atorvastatin 20, 40 mg; simvastatin 20, 40, 80 mg; pravastatin 20, 40 mg p<0.002 vs atorvastatin 40 mg; simvastatin 40, 80 mg; pravastatin 40 mg Adapted from Jones PH et al. Am J Cardiol 2003;92:152160
18 18
ATV 40 mg
Pre-treatment 1 4
IVUS Lipids
atorvastatin 80 mg (n=650)
2 2
Lipids Tolerability
3 0
4 13
5 26
6 39
7 52
8 65
9 78
10 91
11 104
Tolerability
Headlines Results:
Treatment with Crestor (rosuvastatin) or atorvastatin for two years resulted in statistically significant regression in the primary efficacy measure, change from baseline in percent atheroma volume (PAV) in a 40 mm segment of the targeted coronary artery as assessed by intravascular ultrasound (IVUS). Crestor 40mg demonstrated a numerically greater reduction versus atorvastatin 80mg, but did not reach statistical significance (-1.22% vs. -0.99%; p=0.17). For the secondary efficacy measure of normalized total atheroma volume (TAV), Crestor demonstrated a (TAV) 3 vs. -4.42 mm3; p=0.01). statistically significant reduction compared with atorvastatin (-6.39 mm Product Performance
CAD=coronary artery disease; IVUS=intravascular ultrasound Data and analyses presented by the studys academic investigators at AHA in Nov 2011 and published in NEJM the 15th of Nov. ref 10.1056/NEJMMoa1110874
19 19
Seroquel
FY 2011 Sales: $5,828m +8% CER
6,000 5,000 4,000 3,000 2,000 1,000 1 000 0
FY 10 US EST ROW Product Performance
*IMS MAT Nov 2011
US Market share for Seroquel franchise was a market leading 29.8% at end of Dec Seroquel IR were $3,344m, up 8% ROW
US $4,123m +10%
Seroquel IR declined by 8% in Western Europe to $546m Seroquel franchise sales in Emerging Markets were down 1%, where a 41% increase for Seroquel XR was more than offset by declines for Seroquel IR in Brazil following loss of q g exclusivity Seroquel XR now 26% of global franchise revenue - US: 19% of franchise
20 20
FY 11 W EUR EM ROW
Seroquel XR
FY 2011 Sales: $1,490m +27% CER Global
1,400 1,200 1,000 800 600 400 200 0
FY 10 US EST ROW Product Performance FY 11 W EUR EM ROW
21 21
EM ROW $132m +41% EST ROW $89m +34% W. W EUR $490m +30%
Seroquel XR is the fastest growing branded atypical in value globally US US sales for Seroquel XR +22% to $799 million. ROW Sales of Seroquel XR in ROW increased by 32%, accounting for 42% of franchise sales outside the US Emerging markets: Strong growth of Seroquel XR +41% Further launches in Emerging markets planned in 2012
US $779m +22%
Average dose
400mg3
9 months1
600mg3
7-8 months1
4-8 months1
1. IMS Longitudinal patient data 2. AZ SEROQUEL Clinical Development program 3. US 2005 Patient Record Dosing Study (Gallagher Research) 4. Datamonitor
Product Performance
22 22
Symbicort
FY 2011 Sales: $3,148m +11% CER Global
3,000 2,500 2,000 1,500 1 500 1,000 500 0
FY 10 US EST ROW Product Performance FY 11 W EUR EM ROW
23 23
Growing 6 times faster than Seretide/Advair globally (in volume) US Gaining market share continuously in the US (+2.2 pts) despite a declining market and the launch of a 3rd competitor Symbicort share of total prescriptions reaching 20.3% in December 2011 ROW Gaining share in Japan with value share now reaching 32% two years post launch Fast growth in emerging markets (e.g. Russia +41% and Chi +27%) 41% d China 27%) Still growing (volume) in Europe more than 11 years after launch
US $846m +17%
15%
10%
5%
0% May/07
Oct/07
Mar/08
Aug/08
Jan/09
Jun/09
Apr/10
Sep/10
Feb/11
Jul/11
Dec/11
TRx Share
Product Performance
24 24
Nexium
FY 2011 Sales: $4,429m, -12% CER
5,000 4,500 4,000 3,500 3 500 3,000 2,500 2,000 1,500 1,000 500 0
FY 10 US EST ROW Product Performance FY 11 US $2,397m -11% EM ROW $730m +20% EST ROW $540m +10% W. EUR $762m -39%
W EUR EM ROW
US Generic penetration have significant impact on PPI market - decline in branded product p prescription demand p Cost effective promotion - No direct detailing support - Effective use of new channels Digital Customer service representatives Telemarketing ROW Emerging Markets +00% - Chi +38% China 38% Launched in Japan in September 2011 (PPI market in Japan was $2bn in 2010) W t Western Europe -39% E 39% - Generics are available in the majority of the European markets including UK, France, Spain, France Spain Italy and Germany
25 25
Western Europe
Data exclusivity expired 2010 Generics are available in all major European markets incl France, Spain, Italy, UK and Germany
Established ROW
Japan: Nexium Launched in Sept 2011 Canada: Ongoing patent litigation
Emerging Markets
Growth product China: Nexium i.v. included in 2009 NRDL listing Strong growth in 2011 listing. +38% CER
Product Performance
26 26
Iressa
FY 2011 Sales: $554m +32% CER Western Europe +147%
EM ROW $221m +34%
500
Strong launch uptake 80% of all 1st line EGFR M+ advanced NSCLC patients receiving IRESSA Emerging Markets +34%
400
300
EST ROW $204m +2%
g Including a 42% increase in China 1st line EGFR M+ approvals has been granted in majority of Asian countries Established ROW 1st line EGFR M+ approval received in Japan Q4
200
100
0
FY 10 US EST ROW Product Performance FY 11
W EUR EM ROW
27 27
Faslodex
FY 2011 Sales: $546m +55% CER
EM ROW $83m +28% EST ROW $6m +100%
Gl b l Global Value market share 60% (advanced breast cancer hormonal market) Faslodex 500mg now approved in 60 countries The conversion to the 500mg dose has been consistently successful across markets US & Western Europe together delivered 89% of global growth in 2011 Established ROW Launched in Japan in Nov 2011
US $264m +71%
W EUR EM ROW
28 28
ONGLYZA Franchise: A new medication for type 2 di b t in a growing DPP4 class diabetes i i l
Approved in 68 countries (>45 launched) US, Canada, China, Mexico, India, Brazil, Australia, Russia and all EU US: Launched July 2009 - 2nd to US market - Kombiglyze XR (Onglyza & metformin) launched Jan 2011 - First once-a-day DPP4 plus metformin XR FDC EU: Launched October 2009 - 3 d DPP4 i hibit on th EU market 3rd inhibitor the k t - Komboglyze (Onglyza & metformin IR FDC) received marketing authorisation in Nov 2011
Product Performance
Onglyza and dapagliflozin are jointly developed and marketed by AstraZeneca and Bristol-Myers Squibb.
29 29
DPP4 class growing globally and have now surpassed TZDs DPP4's are now the leading BRANDED class DPP4 s by value(~$6bn*) and volume
NIAD Class Global Volume (PDOT) Share
NIAD Class Global Value (USD) Share
Metformin (MET), Sulfonylurea drugs ( ), thiazolidendiones (TZD), Dipeptidyl p p ( ), y g (SU), ( ), p p y peptidase-4 inhibitors (DPP4), alpha glucosidase inhibitors (AGI), Meglitinides (Glinide), Glucagon-like peptide-1 (GLP-1)
Product Performance
Source: AstraZeneca and Bristol-Myers Squibb. * Source: IMS Health MDART/MIDAS 3Q 2011 MAT.
30 30
ONGLYZA Franchise
FY 2011 Global Alliance Revenue: $211m +206% CER
200
EM ROW $14m +367% EST ROW $7m +250% W. EUR $34m +240%
150
US The ONGLYZA Franchise grew by 6.5 TRx share points during 2011 ~30% of US DPP4 market is FDC and ~ 1/3 of new patients receiving a DPP4 & metformin FDC are given Kombiglyze XR K bi l Kombiglyze XR success h lift d O l has lifted Onglyza franchise share of new patients to ~25% in the DPP4 class EU Later launches stronger e.g. in Greece, Norway, and Hungary, Patient Days of Therapy (PDOT) volume shares are above average l h b Est ROW / EM LatAM: launch performance g p good Launched in China Q4 2011 as the first DPP4 inhibitor F th approvals and l Further l d launches h expected during 2012
31 31
100
50
US $156m +189%
0
FY 10 US EST ROW Product Performance FY 11 W EUR EM ROW
11.67%
10% 8% 6%
5.53%
4% 2% 0%
4.66%
01-01-11
02-01-11
03-01-11
04-01-11
05-01-11
06-01-11
07-01-11
08-01-11
09-01-11
10-01-11
11-01-11
Onglyza
Kombiglyze XR
Onglyza Family
Product Performance
Source: IMS NPA Monthly data ending Dec 2012 Onglyza jointly developed and marketed by AstraZeneca and Bristol-Myers Squibb.
12-01-11
32 32
Vimovo
Approved i US and EU A d in d
Delayed release NSAID naproxen with immediate release esomeprazole Overall 71 Regulatory Submissions, 41 Regulatory Approvals and 28 launches (US, UK, Netherlands (RMS), Canada, Bulgaria, Ireland, Latvia, Estonia, Lithuania Finland Slovakia, Sweden, Switzerland, Philippines, Estonia Lithuania, Finland, Slovakia Sweden Switzerland Philippines New Zealand, Belgium, Spain, Austria, Italy and others) for Vimovo. Global revenue of $34m in 2012 US - VIMOVO performance to date reflects the challenges of launching a branded product into a highly genericised US market EU - Majority of launches occurred in 2011 - Launch will follow pricing and reimbursement procedure for each country Row - New launches during 2012 in Brazil, Mexico, Russia and Australia
33 33
Product Performance
Vimovo
Approved i US and EU A d in d
Over 151 Million People Suffer From Osteoarthritis Pain1 Low Satisfaction
Up to 30% of OA patients switch or augment therapy in a year, mainly due to efficacy and side effects2 d id ff
GI Risk
More than 50% of OA patients on chronic NSAIDs are at GI Risk4 ~1 in 4 OA patients on NSAIDs are co-prescribed a PPI3
Product Performance
34 34
Vimovo
Proven OA pain relief with built-in gastroprotection P i li f ith b ilt i t t ti
Demonstrated Significant Risk Reduction in Endoscopic GUs at 6 Months
30%
82% RR 71% RR
Approval based on studies 301 and 302, which demonstrated : - Significant endoscopic gastric ulcer risk reduction vs. EC naproxen - Gastric ulcers reduced even in presence of low dose aspirin - Significantly lower rate of discontinuation due to UGI AEs (including DU) vs EC naproxen
23.10%
24.30%
GU Incidence
p<0.001
p<0.001
7.10%
PN400-301
PN400-302
Product Performance
35 35
36 36
Source: Kantar Health EpiDatabase except for Germany, which sources from Decision Resources. 2011 estimates of incidence
37 37
Approved in 64 Markets
Launched* in 37 Markets
* commercially available y
Regulatory Approvals
BRILINTA regulatory approval in 64 countries with labels reflective of the PLATO trial. Provides access to 58% of global incident ACS population
Commercial Launch
BRILINTA commercial launches in 37 markets
Product Performance
As of 31st of Jan
39 39
(N=18,624) (N 18 624)
Clopidogrel If pretreated, no additional ld; if nave standard 300-mg ld, nave, ld then 75-mg od maintenance;
(additional 300 mg allowed pre-PCI)
Product Performance
ASA = acetylsalicylic acid; bd = twice daily; CVD = cardiovascular disease; ld = loading dose; MI = myocardial infarction; NSTEMI = non-ST-segment elevation MI; od = once daily; STEMI = ST-segment elevation MI; UA = unstable angina
40 40
Product Performance
K-M = Kaplan-Meier Source: AZ US promotion material based on Plato study
41 41
Product Performance
Source: AZ US promotion material based on Plato study
42 42
12 10 8 6 4 2 0 0 60 120 ASA L ( 300 mg) : HR (95% CI), 0.79 (0.71, 0.88) Low (< ) ASA High (> 300 mg) : HR (95% CI), 1.45 (1.01, 2.09) 180 240 300 360
43 43
R&D &
R&D
2.
3. 3
Organisational footprint
Ongoing* Ongoing
Ongoing
4.
R&D
46 46
Late-stage Development L t t D l t
R&D
47 47
R&D
48 48
Link between target / disease Predictive biomarkers Bioavailability and tissue exposure H Human PK/PD prediction di ti Differentiating safety Reactive metabolites Scientific evidence in lead indication Stratification of patient population Differentiated value proposition Embedded payer perspective
Right safety
Right patients
Right commercial
R&D
49 49
Number of projects s
R&D
The AstraZeneca pipeline now includes [86] projects, of which 79 are in the clinical phase of development and 7 are either launched or approved.
50 50
St Petersburg, Russia , Molndal, Sweden Cambridge, UK Reims, France Osaka, Japan Shanghai, China Bangalore, India
San Francisco, CA
Global R&D Network g g p p Reducing Geographical footprint & Headcount Broader Technology base
l
R&D
51 51
Personalised healthcare
Predictive sciences
R&D
52 52
TC-5214
Europe Japan Europe Europe, USA, Japan & China. (500 mg) US Europe & USA US & Europe Japan Europe 1st Line NSCLC Japan Europe Pegasus LCM Russia US, CAN, Brazil Further Markets Europe
Fostamatinib F t ti ib
Europe & USA
Dapagliflozin
Europe & US
(PUB) China
MEDI-3250
US
EU
R&D
53 53
R&D
Estimated Filing
EU Japan Emerging
Cardiovascular
Brilinta/Brilique ADP receptor antagonist Dapagliflozin# SGLT2 inhibitor arterial thrombosis diabetes III III Launched Filed** Launched Filed 1H 2013 1H 2013 Launched Filed
Neuroscience
TC-5214# NKTR-118# neuronal nicotinic channel modulator oral peripherally-acting opioid antagonist major depressive disorder (adjunct) opioid-induced constipation III III 3Q 2012 2H 2013 2015 2H 2013
Oncology
Caprelsa (vandetanib) Ranmark# (denosumab) VEGFR/EGFR tyrosine kinase inhibitor with RET kinase activity anti-RANKL Mab medullary thyroid cancer bone disorders stemming from bone metastasis III III Launched Filed 2014 Approved Filed
Infection
Q-LAIV Flu Vac (MEDI-3250*) Zinforo# (ceftaroline) live, attenuated, intranasal influenza virus vaccine (quadrivalent) extended spectrum cephalosporin with affinity to penicillin- binding penicillin proteins beta lactamase inhibitor/ cephalosporin seasonal influenza III Filed 4Q 2012
III
Filed
3Q 2011
CAZ-AVI# (CAZ-104)
III
2014
2014
2014
R&D
#Partnered
Europe prevalence is 6.9% with highest rates (>11%) in Germany, Austria, y, , Switzerland, and Portugal
India and China will comprise nearly 33% of the worlds total patients with diabetes in 2030
CVGI
Source: WHO
56 56
~30 Years
Sources: ADOPT, UKPDS (*) According to the ADA; (**) according to the AACE/ACE; (***) according to the NIH (*) According to the ADA; (**) according to the AACE/ACE; (***) according to the NIH
CVGI
57 57
CVGI
Dapagliflozin is being jointly developed and marketed by AstraZeneca and Bristol-Myers Squibb.
58 58
CVGI
Dapagliflozin is being jointly developed and marketed by AstraZeneca and Bristol-Myers Squibb.
59 59
Monotherapy
Insulin alone
H2H vs. SU Add-on Metformin Add-on SU Add-on TZD Add Add-on DPP4 (IIIb)
6-month data from the monotherapy (study 13) and add-on to metformin (study 14) studies presented 2009 Study 6 (add-on to insulin) presented at ADA 2010 Data from 2 further studies (H2H vs SU add on to SU) presented at EASD 2010 vs. SU, add-on Phase III data from Studies 4, 14 and 21/34 presented at ADA in June 2011 12 dapagliflozin abstracts presented at the EASD in Sept 2011 Annual Meeting, including: eight primary clinical data presentations. FDA advisory committee held on the 19th of July 2011
CVGI
Onglyza and dapagliflozin are jointly developed and marketed by AstraZeneca and Bristol-Myers Squibb.
60 60
Major Depressive Disorder (MDD) is a highly prevalent & debilitating disease with significant levels of unmet need
43
nd 2
18 44%
Neuroscience
1 3
million patients are treated with drugs from a p g diagnosed population of 23 million globally 1
dont achieve remission after two sequential medications over a six months period3
Decision Resource Cognos Report August 2009 , 2 - WHO website key facts on Depression, Ref 2. Rush et al, Am J Psychiatry 2006; 163:19051917 Derived from steps 1 and 2, 56.1 patients (36.8+19.3) are remitters; 43.9 are non-remitters (44%)
61 61
TC-5214 Phase 2b adjunct study demonstrated clinical efficacy in MDD improving over duration of trial
Mean ch hange in HAM Score fr M-D rom start of randomise treatment o ed t
-2 -4 -6 -8 10 12 14 16
Exciting Phase 2 results where TC-5214 demonstrated clinical efficacy in MDD The Phase 3 RENAISSANCE clinical program will sequentially readout from Q4 2011 until Q2 2012 Filings planned in the US in 2H 2012 and in the EU in 2015
** *** ** ** **
Impr rovement
***
1 2 4 6 8
Neuroscience
62 62
2012
2013
2014
2015
H2
PLANNED SUBMISSION
PLANNED SUBMISSION
Monotherapy
Phase II trial
H2
PHASE III DECISION POINT
Neuroscience
63 63
Flexible dosing
Flexible dosing
Fixed dosing
US and India
Europe
US and India
US
940
940
2234
2236
2000
288
288
684
684
At least 300 for 6 months & 100 for 1 year 1-4mg TC-5214 BID or placebo
Dose
ClinicialTrials.gov identifier
NCT01157078
NCT01180400
NCT01152554
RENAISSANCE 3 & 2: Top line data announced on the 8th of Nov and 20th of Dec. Dec The studies did not meet their primary endpoints of change on the Montgomery-sberg Depression Rating Scale (MADRS) after eight weeks of treatment with TC-5214 as compared to placebo
64 64
Phase IIb data (TASKi 2) published in the New England Journal of Medicine, demonstrated1
anti-TNF like levels of efficacy Main adverse events of interest are GI tolerability, AST/ALT changes and raised blood pressure all of which appeared to be manageable at doses being investigated in phase 3 TASKi3 study in patients who failed biologic therapies failed to meet primary endpoint in phase 2
Believed to be due to technical issues with the study design
Fostamatinib long term extension (LTE) study presented at ACR in Nov Fostamatinib is in Phase III development for the treatment of RA in patients with an inadequate response to disease modifying anti-rheumatic drugs (DMARDs), including methotrexate (MTX) Initial regulatory filings anticipated in 2013 in US & EU Inflammation
New England Journal of Medicine, An Oral Spleen Tyrosine Kinase (Syk) Inhibitor for Rheumatoid Arthritis, Weinblatt ME, Kavanaugh A, Genovese MC, et al. September 30, 2010; 363:1303-1312
1- The
65 65
Rheumatoid Arthritis is a prevalent & debilitating di ith i ifi tl l f t d disease with significant levels of unmet need
20 9 7 3
Inflammation
Million RA patients (approx. 80%) do not achieve remission with a traditional disease modifying anti-rheumatic drug (DMARD) alone4 Million RA patients are treated with biologic therapy following inadequate response to a DMARD (accounting for $12 bn in sales, approx. 90% of the RA market2,3)
1 WHO report: The global burden of rheumatoid arthritis in the year 2000 http://www.who.int/healthinfo/statistics/bod_rheumatoidarthritis.pdf 2 Decision Resource Pharmacor 2010 , 3 IMS Health MIDAS sales database 4 Blumberg SN, Fox DA. Rheumatoid arthritis: guidelines for emerging therapies. Am J Manag Care 2001 ; 7 (6): 617 -26
66 66
Fostamatinib opportunity in RA
Target Population Patients who have an inadequate response to traditional diseasemodifying anti-rheumatic drug (DMARD) therapy
Profile in phase II I Improved outcomes in RA patients with d i i ih methotrexate background treatment, as measured by ACR and DAS p Fast onset of action - 36% of patients achieved a response within 1 week Initial evidence of preventing further bone and cartilage damage Manageable safety and tolerability profile Improved patient QoL Oral formulation No administration pain as associated with injected therapy No need to visit hospital / physicians office for infusions ffi f i f i
Inflammation
67 67
Placebo acebo
Ref:
Inflammation
The New England Journal of Medicine, An Oral Spleen Tyrosine Kinase (Syk) Inhibitor for Rheumatoid Arthritis, Weinblatt ME, Kavanaugh A, Genovese MC, et al. September 30, 2010; 363:1303-1312
68 68
Inflammation
69 69
NKTR-118 is part of the exclusive worldwide license agreement announced on September 21, 2009, between AstraZeneca and Nektar Therapeutics.
1 2 3
Neuroscience
4 5
IMS MAT. December 2010. Thomas, J. Opioid-Induced Bowel Dysfunction. Journal of Pain and Symptom Management. 2008;35(1):103-113. Bell, Bell T et al OBD symptoms impair quality of life and daily activities regardless of frequency and duration of opioid treatment: al. activities, results of a U.S. patient survey (PROBE survey). Poster presented at The 25th Annual Scientific Meeting of the American Pain Society. San Antonia, TX, USA. Pappagallo, M. Incidence, prevalence, and management of opioid bowel dysfunction. Am J Surg. 2001:182;S11-S18. Fakata, K. Peripheral Opioid Antagonists: A Therapeutic Advance for Optimizing Opioid Gastrointestinal Tolerability. The Journal of Family Practice. 2007;56:S1-S12.
70 70
NKTR-118 significantly increases the frequency of spontaneous b f t bowel movements and reduces l t d d time to first SBM in phase 2 studies
Change from Baseline in Spontaneous Bowel Movements (SBMs/week)
NS P = NS
Ch hange in SBM (SE)
P = 0.002
P = 0.0001
Time (hrs) to First SBM ( S
60 50 40 30 20 10 0
5 mg 25 mg 50 mg 6.2 6.6 2.9 28.2 48.6 44.9
5 4 3 2 1 0
5mg 25mg 50mg
Placebo
NKTR-118
Placebo
NKTR-118
Neuroscience
71 71
Neuroscience
72 72
Oncology
73 73
MRSA MDRSP
S. S pneumoniae i S. aureus
Infection
74 74
Infection
75 75
Complicated skin and soft tissue infections (cSSTI) d ( SSTI) and community acquired pneumonia it i d i (CAP)
cSSTI CAP
Infection
76 76
Noninferiority
10
20
Modified intent-to-treat CANVAS 1 Clinically evaluable Modified intent-to-treat CANVAS 2 Clinically evaluable FOCUS 1 Modified intent-to-treat Clinically evaluable Modified intent-to-treat FOCUS 2 Clinically evaluable
1.2
CAP
Favours Comparator
Favours Zinforo
Infection
77 77
CAZ AVI: to overcome antibiotic-resistance and treat the increasing number of infections resistant to existing therapies
Globally, Globally over 1m patients a year suffer from infections known or suspected to be resistant to cephalosporins which are routinely used to treat Gram-negative infections. This figure is expected to grow by >25% over the next decade CAZ-AVI CAZ AVI combines a broad spectrum cephalosporin (ceftazidime) and a novel broad-spectrum beta-lactamase inhibitor (avibactam, formerly NXL104) AstraZeneca and Forest will initiate Phase III programme for CAZ AVI to treat serious Gram-negative bacterial infections including Complicated IntraAbdominal Infections (cIAI) and Complicated Urinary Tract Infections (cUTI) p g g pp global regulatory filings in 2014 g y g The trial programme is designed to support g and will include five Phase III trials, based on positive results from two Phase II trials In the collaboration, development costs will be shared between AstraZeneca collaboration and Forest Forest will have the rights to commercialise CAZ AVI in North America, AZ has rights to commercialise CAZ AVI in rest of world
78 78
Infection
CXL
(beta lactamase inhibitor and cephalosporin)
MEDI1123 Tremelimumab
(CTLA-4 monoclonal antibody) (anti-PDGFR-alpha MEDI575 (anti PDGFR alpha mAb)
New target
Follower
R&D
79 79
AZD6244 Selumetinib
(MEK inhibitor)
CXL
(beta lactamase inhibitor and cepholasporin)
MEDI1123 Tremelimumab
(CTLA-4 monoclonal antibody)
Asthma with MEK inhibitorallergic component i hibit Leading cause of cancer mortality 25% have KRAS mutation and poor prognosis Breast cancer Phase 2: Significant improvement in Progression-free survival Severe sepsis p Trend for improvement in overall survival
R&D
80 80
81
Planning Assumptions
Growth of current products Successfully launch the new products Drive growth in emerging markets Develop innovative p channels to meet customer needs
Implement asset strategy & LEAN Drive efficiencies in Sales & Marketing and G&A d Focus Capex on productivity improvements p
- Disease area focus - Reduce site footprint - Externalisation - Build stronger relationship l ti hi with payers
Collaboration
Planning Assumptions
82 82
- No premature loss of market exclusivity for key products - No material change in Fx rates for principal currencies vs average January 2010 rates y
Euro has significantly weakened vs USD
Planning Assumptions
83 83
Net Finance Expense Other Operating Income Tax Rate Core EPS
Planning Assumptions
84 84
Currency: January 2012 average rates: - $1 = 0.645 - $1 = EUR 0 775 0.775 - $1 = SEK 6.849 - $1 = JPY 76.923 Actual 2012 rates may differ materially from January 2012 rates upon which guidance is based 2012 currency sensitivity estimator is available at www.astrazeneca.com
Planning Assumptions
85 85
Planning Assumptions
86 86
Sustain double digit growth in emerging markets - Drive growth and new launch portfolio - Broaden portfolio to include branded generics
Strategy
* Updated to reflect recent pipeline changes Onglyza and dapagliflozin are jointly developed and marketed by AstraZeneca and Bristol-Myers Squibb.
Business shape
Strategic Initiatives
Maintain gross margin >80% - Complete asset strategy & API outsourcing - Drive LEAN Sigma Improve Sales & Marketing effectiveness and efficiency - New channels and approaches pp - Technology investment - Quality initiatives Increase G&A cost efficiency and flexibility - Process improvement and automation - Consolidation & selective outsourcing Procurement savings across all functions Focus on working capital management Core pre-R&D operating margin in the range of 48-54% Planning assumptions 2010-2014
Strategy
89 89
Returns period Supply chain capacity Sales and Marketing (mature markets) N Non-customer f i t facing roles l
Site footprint
New talent
Invest/Innovate
Achieving revenue and Core pre-R&D margins in planning range Delivering restructuring programmes Tight management of working capital, tax & interest
Specific business needs Debt repayment Progressive dividend policy Share repurchases
Strategy
91 91
2010-2014 in summary
Reinvest 40-50% 40 50%
Pre-R&D p post tax cash flow
Marketed Products
Revenue $ $28-34bn
Planning Assumptions
92 92
3.7
8.3
2.8
93
* R&D includes internal R&D expenditures, net of tax and depreciation/amortisation,and externalisation.
93 93
Shareholder Distributions
Distribution policy and financial strategy to balance needs of business investment, financial creditors and shareholders i t t fi i l dit d h h ld The Board to keep under review the opportunity to return surplus capital via periodic share repurchases
2011: $5.6bn net share repurchases. Original target in 2011: $4bn net augmented by net proceeds from the sale of Astra Tech. 2012 target: $4.5bn net, subject to business needs
Planning Assumptions
94 94
Strategy
95 95
Programme cost: $1.2 billion was charged in 2010, and $0.9 billion in 2011 $1.0 2011 Benefits: Realised $1 0 billion through end of 2011, and are on track to deliver about [two thirds] of the remaining benefits by end 2012, with the remainder by 2014 *Headcount Impact: Some employees for which charges relate remain with the business at Dec 31st 2011 but will leave in 2012
Strategy
96 96
(3,000)
Wave 1 & 2 20,500*
-9,600 Net
(8,000)
(13,000)
(18,000)
(23,000)
Headcount Dec 31st 2006 (66,800) Headcount Dec 31st 2011 (57,200) *Some Employees affected by the Wave 2 programme are still employed at Dec 31st 2011 Includes the acquisition of MedImmune
Strategy
97 97
*Subject to completion of requisite consultation process. ** We charged $261 million of this $2.1 billion Phase 3 restructuring charge during fourth quarter 2011 [Headcount Impact: Some employees for which charges relate remain with the business at Dec 31st 2011 but will leave in 2012.] [Includes roughly $200m of demolition costs.]/[Cash vs non cash]
Strategy
98 98
Newsflow 2011 e s o 0
Newsflow
Q2
Q3
Q4
Q1 13 Q2 13
26th Apr Fostamatinib Initial data from OSKIRA program NKTR-118 Initial data from KODIAC program
26th Jul
25th Oct
Newsflow
100 100
AstraZeneca st a e eca
History
CAGR
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
History
102 102
31
15
70 60 50 40 30 20 10 0 -10 1999 Net Funds Pre-R&D Post Tax Cash Flow After Tax R&D* Capex Merck Acquisitions Distributed to Payments & Disposals Shareholders Other 2011 Net Funds
111
13 26 Div
23 SBB
* R&D includes internal R&D expenditures, net of tax and depreciation/amortisation,and externalisation. Source: AZ annual reports
103 103
Note: Peers line data represents an average of the total shareholder return for (including AZ) those companies which AZ classifies as its peers Abbott, BMS, Eli Lilly, GSK, J&J, Merck, Novartis, Pfizer, Roche and Sanofi
History
104 104
Note: Peers line data represents an average of dividend growth for (including AZ) those companies which AZ classifies as its peers Abbott, BMS, Eli Lilly, GSK, J&J, Merck, Novartis, Pfizer, Roche and Sanofi
History
Source: Bloomberg
105 105
106
Growth Drivers
Growth Drivers
107 107
The global population is ageing, with older patients consuming more healthcare than younger patients
Global population aged 65 and older, millions older
65-69 70-74
US
977
477
Canada
UK
2005
2030
75-79 80-100
0x
2x
4x
6x
8x
10x
12x
Growth Drivers
108 108
Worldwide, the top 10 pharmaceutical therapy areas are expected to grow by $100bn 2010 16 t dt b $100b 2010-16
120,000
100,000
20,000
Growth Drivers
109 109
E7 countries
5,000 Increasing
2010
2016-2042 ave.
110 110
Growth Drivers
Growth Drivers
Note: R2=0.8, N=63, United States outlier excluded from the regression analysis. Source: World Market Monitor; IMS.
111 111
Emerging markets are forecast to contribute ~70% of pharma growth during 2010 2015 70% 2010-2015
Growth Drivers
112 112
+21% p.a.
Source: Economist Intelligence Unit, 2010, China NSBA, Indian NFHS, RAND, Brazil PNAD
~$60bn
( 33%) (~33%)
~$90bn
(~50%)
~$30bn $30b
(~17%)
China
114 114
While individual markets have ups and downs, the th portfolio of markets provides steady, tf li f k t id t d strong growth
Standard deviation of year-on-year GDP growth rates 2004-2010 (%pts) rates,
8.6
5.3 3.7
3.6
2.0
The variation of the portfolio is lower than almost all markets individually
Growth Drivers
Source: IMS
115 115
AstraZeneca has built a truly global emerging markets prescription drug business k t i ti d b i
2011 Sales1
Asia-Pacific
$2.2bn
Latin America
$1.5bn
Growth Drivers
1 2
CEEMEA2
$2.1bn $2 1bn
Actual exchange rate. Central and Eastern Europe, Middle East, and Africa (including Turkey); Source: AZ
116 116
Both BRIC-MT and small and mid-sized emerging markets h k t have contributed significantly to our growth t ib t d i ifi tl t th
2004 11 2004-11 AZ emerging markets sales $5.8bn Absolute growth $3.9bn CAGR 17%
$3.6bn
$2.9bn
$1.8bn
15%
$1.9bn $ $1.9bn Small and mid-sized EMs BRIC-MT $1.1bn $0.8bn 2004 $1.7bn
$2.9bn
$2.1bn
20%
2007
2011
117 117
Growth Drivers
Brands dominate the market as brands are the best b t proxy for quality f lit
Emerging market sales1, 2009, Ex-manufacturer
~$50bn ( (~28%) %) ~$90bn (~50%) ~$30bn (~17%) ~$180bn
Growth Drivers
Across 17 selected markets (China, Turkey, India, South Korea, Brazil, Mexico, Poland, Russia, Taiwan, Hungary, Romania, Egypt, Algeria, Saudi Arabia, South Africa, Ukraine, UAE). Source: IMS; AZ analysis.
118 118
Growth Drivers
119 119
$33m $69m
+13%
$158m $11m
$15m $15
$23m
$16m $7m
$91m
2004
2007
2011
2004
2007
2011
2004
2007
2011
Growth Drivers
120 120
65% Our current emerging markets margins are similar to our Europe business 6-7 6 7 years ago
55%
2004
2007
2011
Growth Drivers
Source: AZ internal
121 121
A
Continue to grow our presence in the large BRIC-MT markets
B
Extending our geographic footprint by increasing our involvement in high-growth small and mid-size markets
C
Broaden portfolio to selectively include branded generics
Growth Drivers
122 122
Our goal is to continue double-digit growth, with emerging markets becoming ~25% of ith i k t b i 25% f AZ sales by 2014
AZ emerging markets revenue goal
$12bn
$8bn
$4bn
$0bn
2009
2014
123 123
Growth Drivers
Product Performance
0% +4% +16%
0% +1% +12%
Reported EPS
$1.16
$1.15
0%
-5%
Financial Performance
Performance
125 125
Financial Performance
Performance
126 126
Crestor Seroquel
Seroquel IR Seroquel XR
+11% +15%
+12% +27%
Nexium Symbicort
1,067 839
Financial Performance
Performance
127 127
Financial Performance
Performance
128 128
Crestor
Q4 2011 Sales: $1,771m +11% CER Crestor US TRx +4%
1,800 1,600 1,400 1,200 1,000 800 600 400 200 0
Q4 10 US EST ROW Product Performance Q4 11 W EUR EM ROW
129 129
EM ROW $158m +8% EST ROW $465m +15% W. EUR $305m +5%
- Statin market flat - Share of total prescriptions in Dec 12.3% - Generic atorvastatin launched end November - Crestor TRx volume stable Western Europe were up 5 percent, largely on double-digit d bl di it growth i F th in France and S i d Spain Established Rest of World were up 15 percent, with Japan accounting for half of the increase E Emerging M k t were up 8 percent, where i Markets t h good growth in Emerging Europe and China was partially offset by generic erosion in Brazil Strong brand position for patients at elevated CV risk
US $843m +12%
Seroquel franchise
Q4 2011 Sales: $1,546m +15% CER Seroquel IR: $1,148m +12% Seroquel XR: $398m +27%
1,400 1,200 1,000 800 600 400 200 0
Q4 10 US EST ROW Product Performance Q4 11 W EUR EM ROW US $1,124m +20% EM ROW $81m -6% EST ROW $86m 19% W. W EUR $255m +3%
US Seroquel IR were $910 million, up 18% Market share for Seroquel franchise was a market leading 29.8% at end of Dec p p p y Total prescriptions for the US antipsychotic market were flat in the fourth quarter ROW q Seroquel franchise sales in the Rest of World were $422 million in the fourth quarter, a 3% increase Seroquel XR now 26% of global franchise revenue - US: 19% of franchise - ROW: 44% of franchise
130 130
Seroquel XR
Q4 2011 Sales: $398m +27% CER
400 350 300 250 200 150 100 50 0
Q4 10 US EST ROW Product Performance Q4 11 W EUR EM ROW US $214m +31% EM ROW $34m +37% EST ROW $23m +16% W. W EUR $127m +19%
US Seroquel XR were up 31 percent to $214 million. US Seroquel XR TRx +8% vs a flat market ROW Sales of Seroquel XR in ROW increased by 22%, accounting for 44% of franchise sales outside the US Emerging markets: Strong growth of Seroquel XR 37% Further launches completed in 2011 - MDD in Europe (Launched H1 in UK, Germany, Spain) - MDD and bipolar disorder in Emerging Markets - Xeroquel in France in BPD and schizophrenia in Nov
131 131
Symbicort
Q4 2011 Sales: $839m +13% CER US Symbicort TRx +9% 2% - Fixed combination market -2%
800 700 600 500 400 300 200 100 0
Q4 10 US EST ROW Product Performance Q4 11 W EUR EM ROW
132 132
Symbicort TRx share increased to 20.3% in December 2011 New patient share 26% ROW Established ROW +26% - Fuelled by strong growth in Japan (up 56 percent)
US $242m +26%
Western Europe 1% - Data exclusivity in 10yr markets expired in Aug 2010 - Complex regulatory path for generics Emerging Markets +19% - China +40%
Nexium
Q4 2011 Sales: $1,067m, -13% CER
1,200 1,000 800 600 400 200 0
Q4 10 US EST ROW Product Performance Q4 11 EM ROW $176m +24% EST ROW $132m +5% W. EUR $145m -50%
US $614m -8%
W EUR EM ROW
US Retail volume -8 5% -8.5% - Generic penetration have significant impact on PPI market - decline in branded product prescription demand - low single digit decline in average selling prices was largely due to the impact of US healthcare reform C t effective promotion Cost ff ti ti - No direct detailing support - Effective use of new channels Digital Customer service representatives Telemarketing ROW Western Europe -50% - Generics are available all major European j p markets where France accounting for more than half of the decline Launched in Japan in September Emerging Markets +24% - China +36% 133
133
Iressa
Q4 2011 Sales: $149m +25% CER Strong g g growth in Western Europe and p Emerging Markets each accounting for about half of the sales increase Emerging Markets +38% - Including a 41% increase in China - 1st line EGFR M+ approvals
EST ROW $60m +2%
W EUR EM ROW
134 134
ONGLYZA Franchise
Q4 2011 Global Alliance Revenue: $ 71m + 122% CER
80 70 60 50 40 30 20 10 0
Q4 10 US EST ROW Product Performance Q411 W EUR EM ROW
135 135
EM ROW $5m +150% EST ROW $3m +200% W. EUR $10m +100%
US TRx growth of 1ppt in Q4 Franchise share reached 16.5% at end of Dec Kombiglyze XR success has lifted Onglyza franchise share of new patients to ~25% in the DPP4 class EU Komboglyze received marketing authorisation in EU in Q4 Est ROW / EM Launched in China Q4 2011 as the first DPP4 inhibitor Further approvals and launches expected during 2012
US $53m +121%
IR Contacts
Investor Enquiries US
Ed Seage Jrgen Winroth g edward.seage@astrazeneca.com mob: +1 302 373 1361 j g jorgen.winroth@astrazeneca.com @ mob: +1 917 612 4043 +1 302 886 4065 +1 212 579 0506
IR Contacts
137 137
138 138
Appendices
25%
20%
15%
10%
5%
0%
-5% 5%
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
Appendices
140
950,000
900,000
800,000
Appendices
141