Download - AstraZeneca 2011
General PresentationGe e a ese tat o
February 2012
ContentsPPage
1. Corporate Strategy 3
2 FY 2011 Fi i l P f 72. FY 2011 Financial Performance 7
3. FY 2011 Key Product Performance 15
4 R&D U d t 454. R&D Update 45
5. Strategy update & Planning assumptions 2012+ 81
6 N fl 2011 996. News flow 2011 99
7. AZN - Historic performance & Shareholder returns 101
8 K i d t th d i 1068. Key industry growth drivers 106
9. Q4 Financial & Key Product Performance 124
10 I R l i 13610. Investor Relations contacts 136
11. Appendices 139
22
Corporate StrategyCo po ate St ategy
Strategy
Industry outlook
• Increasing and ageing populations• Expanding populations in new markets• Significant unmet medical need• Continued scientific and technological advance
Growth SectorGrowth Sector
• Decline in R&D productivityPressures onPressures on p y• Established market price pressure• Patent expiries and genericisation
Pressures on returns
Pressures on returns
• Increased R&D productivity opportunities• Adapting sales and marketing model
Leading players will continue toLeading players will continue to Adapting sales and marketing model
• Further cost reduction potential• Improved investment discipline
will continue to earn attractive
returns
will continue to earn attractive
returns
44Strategy
Our vision
AstraZeneca is
Focused
Innovation-driven
Global
Integrated
Global
Biopharma
OUR VALUES
55Strategy
Corporate Strategic priorities Making the
most meaningful difference to patient healththrough great medicines
Increase output • Innovation• Growth of current
Deliver the business
• Implement asset
BusinessShape
PeoplePipeline
• Increase output
• Drive productivity& efficiency- Disease area focus
Innovation
• Accountability
• Lean & agile
Growth of current products
• Successfully launch the new products
Implement asset strategy & LEAN
• Drive efficiencies in Sales & Marketing
d G&A- Reduce site footprint
• Collaboration- Externalisation- Build stronger
l ti hi
• Value orientation• Drive growth in emerging markets
• Develop innovative
and G&A
• Focus Capexon productivity improvements
relationshipwith payers
Manage for long term shareholder value
pchannels to meet customer needs
p
Our values
Manage for long-term shareholder value
666Strategy
FY 2011 Financial 0 a c aPerformance
Financial Performance
FY 2011 Summary
Financial performance• Revenue $33,591m (-2% CER)
Research & Development• Further approvals and launches of Brilique/BRILINTA
• Reflects loss of nearly $2bn from generic competition & further $1bn lost to the impact from government price interventions
• Core EPS $7 28 (+7% CER)
now approved in 64 counties and launched in 37• Nexium and Faslodex approved in Japan• Announced full results from SATURN
• Core EPS $7.28 (+7% CER)• Strong performance of Crestor, Symbicort,
Seroquel XR
• Market authorisation received in EU for KOMBOGLYZE™ in Q4
• On 19th of Jan 2012 FDA issued a complete response letter regarding the NDA for dapagliflozin
Shareholder returns• Dividend 2011 $2.80 (+10%)• Net cash distributions to shareholders
letter regarding the NDA for dapagliflozin• TC-5214 phase III studies, RENAISSANCE 3 & 2,
did not meet their primary endpoints• Announced the decision to discontinue olaparib’s 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
development in serous ovarian cancer Other developments• Disposal of Astra Tech business to DENTSPLY
for appro imatel $1 8bn in cash completed in A g stdividend from 2010 and the first dividend from 2011
for approximately $1.8bn in cash completed in August 2011. Net proceeds added to share repurchases
88PerformanceFinancial Performance
Headline results FY 2011
FY 2011$m
FY 2010$m
CERActual
Revenue 33,591 33,269 +1% -2%
Core Operating Profit 13 167 13 603 -3% -4%Core Operating Profit 13,167 13,603 -3% -4%
Core EPS $7.28 $6.71 +9% +7%
R t t i ($0 63) ($0 62)Restructuring ($0.63) ($0.62)MedImmune/Merck amortisation ($0.32) ($0.29) Intangible Impairments ($0.01) ($0.29)Legal provisions ($0.07) ($0.39) E l B fit $0 40Employee Benefits - $0.40Astra Tech sale $1.08
Reported EPS $7.33 $5.60 +31% +29%Reported EPS $7.33 $5.60 31% 29%
999PerformanceFinancial Performance
Regional revenue performance FY 2011
CERFY 2011 CER
Global Revenue 33 591 -2% -599
CER%
FY 2011$m
CER$m
Global Revenue 33,591 2% 599
US 13,426 -2% -302
Western Europe 8,501 -11% -1,047
Established RoW 5 901 +4% +229Established RoW 5,901 +4% +229
Emerging Markets 5,763 +10% +521
101010PerformanceFinancial Performance
Key brand revenue summary FY 2011
CERFY 2011
Crestor 6 622 +13%
CER%
FY 2011$m
Crestor 6,622 +13%
Seroquel 5,828 +8%Seroquel IR 4 338 +3%Seroquel IR 4,338 +3%Seroquel XR 1,490 +27%
Nexium 4,429 -12%Nexium 4,429 12%
Symbicort 3,148 +11%
1111PerformanceFinancial Performance
Core margin: FY 2011
$mCER
growth % salesDelta vsPY CER
Core Gross Margin 27,619 0% 82.2 +130bps
Revenue 33,591 -2%
Distribution (346) -1% 1.0 0bps
C SG&A (9 918) 2% 29 5 10Core SG&A (9,918) -2% 29.5 -10bps
Core Other Income 845 -8% 2.5 -20bps
Core Pre-R&D Profit 18,200 0% 54.2 +100bps
Core R&D (5 033) +15% 15 0 -220bpsCore R&D (5,033) +15% 15.0 220bps
Operating Profit 13,167 -4% 39.2 -120bps
121212PerformanceFinancial Performance
Cash generation: FY 2011
2011$m
2010$m
Opening net cash/(debt) 3,653 535
EBITDA 15 345 14 235EBITDA 15,345 14,235
Movement in working capital (897) 82
Tax & interest paid* (3,164) (2,612)
Other non-cash movements** (2,080) (463)
9,204 11,242
Tax settlements (1,383) (562)( , ) ( )
Net cash from operating activities 7,821 10,680
131313* Adjusted for Tax settlements, ** Including $1483 million from AstraTech disposal PerformanceFinancial Performance
Cash application: FY 2011
2011$m
Opening net cash/(debt) 3,653
Net cash from operating activities 7,821Net capex (1,195)Astra Tech Disposal Proceeds 1,772Dividends/Net share buy-back (9,370)Other movements 168Other movements 168
Closing net cash/(debt) 2,849
Gross debt (9,328)Cash/Cash equivalents and STIs 12,177
141414PerformanceFinancial Performance
FY 2011 Key ProductFY 2011 Key Product Performance
Product Performance
Crestor FY 2011 Sales: $6,622m +13% CER • Global volume growth 2x statin market (12% vs
6%)
5,000
6,000
EST ROW$1,662m +15%
EM ROW$661m +8%
• Crestor US TRx +4%- Statin market +1%- Generic atorvastatin launched end
3 000
4,000
,
W. EUR$1,225m +5%
November- Crestor TRx volume stable
• Western Europe sales +5%
2,000
3,000
US$3,074m +16%
Western Europe sales 5%• Double-digit growth in France and Spain
• Established ROW sales +15%Japan accounts for half of the increase
0
1,000
FY 10 FY 11
• Japan accounts for half of the increase• Emerging Markets sales +8%
• Good growth in Emerging Europe & ChinaFY 10 FY 11
US W EUR
EST ROW EM ROW
• Generics in Brazil
161616
EST ROW EM ROW
Product Performance
Crestor TRx volume stable post generic t t tiatorvastatin
Generic Atorvastatin
Growth vs prior year8 weeks pre vs 8 weeks post600 000 Atorvastatin
November 30th8 weeks pre vs 8 weeks post
+2% / +2% *Pre/Post
600,000
500,000
400,000
300 000
+6% / +1% *Pre/Post
300,000
200,000
+4% / -10% **Pre/Post100,000
0
09/0
2/11
09/0
9/11
09/1
6/11
09/2
3/11
09/3
0/11
10/0
7/11
10/1
4/11
09/0
2/11
10/2
8/11
11/0
4/11
11/1
1/11
11/1
8/11
11/2
5/11
12/0
2/11
12/0
9/11
12/1
6/11
12/2
3/11
12/3
0/11
TRx NRx NBRx
1/6/
112
1/13
/12
1/20
/12
171717* 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)Product Performance
Crestor: STELLAR studyLDL C l i th d
LDL-C: LS mean change from baseline at week 6
LDL-C lowering across the dose range
20mg
40mg
0 -10 20 -30 -40 -50 -60-5 -15 -25 -35 -45 -55
10mg CRESTORmg mg
80mg
40mg
mg
10mg
20mg
CRESTOR
Atorvastatin^^^*** ^^^
10mg
20mg
40mg
80mg
*** *** ^^^***Simvastatin
CRESTOR 10
*** *** ^^^***
10mg
20mg
40mg
*** *** ***
Pravastatin
CRESTOR 20mg (-52%)
CRESTOR 10mg (-46%)
DATA ON FILE
181818
*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;92:152–160 Product Performance
SATURN: IVUS study vs LipitorHypothesis: the greater impact of Crestor on LDL-C & HDL-C will translate
Coronary Artery Disease Patients
1300 Re randomised
Hypothesis: the greater impact of Crestor on LDL-C & HDL-C will translateinto a greater impact on atherosclerosis
Disease Patients N~2900 screened
Hypercholesterolaemic
Left main coronary artery: RSV 20 mg Crestor 40 mg (n=650)
Re-randomised patients
≤50% reduction in lumen diameter
Target coronary artery: <50% reduction in lumen
diameter of
ATV 40 mg atorvastatin 80 mg (n=650)
diameter of ≥40 mm segment
18-75 yearsVisit:Week:
1–4
30
413
526
639
752
865
978
1091
11104
2–2
Pre-treatment
IVUSLipids
Tolerability
LipidsLipidsIVUSLipids
LipidsLipidsTolerability
TolerabilityTolerability Tolerability
Tolerability
Headlines Results:Treatment with Crestor (rosuvastatin) or atorvastatin for two years resulted in statistically significant regressionin the primary efficacy measure, change from baseline in percent atheroma volume (PAV) in a ≥40 mm segment ofthe 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
191919
CAD=coronary artery disease; IVUS=intravascular ultrasound•Data and analyses presented by the study’s academic investigators at AHA in Nov 2011
and published in NEJM the 15th of Nov. ref 10.1056/NEJMMoa1110874
For the secondary efficacy measure of normalized total atheroma volume (TAV), Crestor demonstrated astatistically significant reduction compared with atorvastatin (-6.39 mm3 vs. -4.42 mm3; p=0.01).
Product Performance
Seroquel Seroquel IR: $4,338m +3%Seroquel XR: $1,490m +27%
6,000
FY 2011 Sales: $5,828m +8% CERGlobal• Seroquel franchise value market share at
5,000
W EUR
EST ROW$317m 1%
EM ROW$352m -1%
Seroquel franchise value market share at 27.8%*
US• Market share for Seroquel franchise was a
3,000
4,000W. EUR$1,036m +7%
• Market share for Seroquel franchise was a market leading 29.8% at end of Dec
• Seroquel IR were $3,344m, up 8%ROW
1 000
2,000US$4,123m +10%
ROW• Seroquel IR declined by 8% in Western
Europe to $546m• Seroquel franchise sales in Emerging Markets
0
1,000
FY 10 FY 11
• 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 FY 10 FY 11 q gexclusivity
• Seroquel XR now 26% of global franchise revenue
US W EUR
EST ROW EM ROW
202020
- US: 19% of franchise- ROW: 42% of franchise
EST ROW EM ROW
Product Performance*IMS MAT Nov 2011
Seroquel XRFY 2011 Sales: $1,490m +27% CER
Global
1,200
1,400
W EUR
EST ROW$89m +34%
EM ROW$132m +41%
• Seroquel XR is the fastest growing branded atypical in value globally
US
800
1,000W. EUR$490m +30% • US sales for Seroquel XR +22% to $799
million.ROW
400
600 US$779m +22%
• Sales of Seroquel XR in ROW increased by 32%, accounting for 42% of franchise sales outside the US
0
200
FY 10 FY 11
• Emerging markets: Strong growth of Seroquel XR +41%
• Further launches in Emerging markets planned in 2012FY 10 FY 11 planned in 2012
US W EUR
EST ROW EM ROW
212121
EST ROW EM ROW
Product Performance
Seroquel XR: new indications to drive growth…
SCHIZOPHRENIAHigh dose
Smaller market
BIPOLARMedium dose
Medium market
MDD (DEPRESSION)Low dose
Large marketAveragedose
Smaller market Medium market Large market
Si e ofSize of Patient
population
600m
g3
400m
g3
150m
g2
Average treatment duration
9 months1 7-8 months1 4-8 months1
222222
1. IMS Longitudinal patient data
2. AZ SEROQUEL Clinical Development program
3. US 2005 Patient Record Dosing Study (Gallagher Research)
4. Datamonitor Product Performance
SymbicortFY 2011 Sales: $3,148m +11% CER
Global• Growing 6 times faster than Seretide/Advair
globally (in volume)US2,500
3,000
EST ROW$418m +35%
EM ROW$450m +19%
• Gaining market share continuously in the US (+2.2 pts) despite a declining market and the launch of a 3rd competitor
1 500
2,000
W. EUR$1,434m +0%
$418m +35%
• Symbicort share of total prescriptions reaching 20.3% in December 2011
ROW1,000
1,500 $ ,
• Gaining share in Japan with value share now reaching 32% two years post launch
• Fast growth in emerging markets (e.g. Russia 41% d Chi 27%)
0
500
FY 10 FY 11
US$846m +17%
+41% and China +27%)• Still growing (volume) in Europe more than 11
years after launch
FY 10 FY 11
US W EUR
EST ROW EM ROW
232323
EST ROW EM ROW
Product Performance
Symbicort: Steady share growth in USi l hsince launch
25%
20.26%
21.53%
20%
15%
ket S
hare
(%)
10%
ymbi
cort
Mar
k
5%
Sy
0%May/07 Oct/07 Mar/08 Aug/08 Jan/09 Jun/09 Nov/09 Apr/10 Sep/10 Feb/11 Jul/11 Dec/11
242424
TRx Share NRx Share
Product Performance
NexiumUS
5,000
FY 2011 Sales: $4,429m, -12% CERUS• Generic penetration have significant impact
on PPI market - decline in branded product prescription demand
3 500
4,000
4,500
EM ROW$730m +20%
p p• Cost effective promotion
- No direct detailing support- Effective use of new channels
2,500
3,000
3,500
W. EUR$762m -39%
EST ROW$540m +10%
Effective use of new channels• Digital• Customer service representatives• Telemarketing
1,000
1,500
2,000
US$2,397m -11%
• TelemarketingROW• Emerging Markets +00%
Chi 38%
0
500- China +38%
• Launched in Japan in September 2011 (PPI market in Japan was $2bn in 2010)W t E 39%FY 10 FY 11 • Western Europe -39%
- Generics are available in the majorityof the European markets including UK, France Spain Italy and Germany
FY 10 FY 11
US W EUR
EST ROW EM ROW
252525
France, Spain, Italy and GermanyEST ROW EM ROW
Product Performance
Nexium geographical dynamics
US Western Europe
• Predominantly generic PPI market
• Brand equity and innovative salesand marketing channels help drive
• Data exclusivity expired 2010
• Generics are available in all majorEuropean markets incl France,
profitability of Nexium Spain, Italy, UK and Germany
Established ROW Emerging Markets
• Japan: Nexium – Launched in Sept 2011
• Canada: Ongoing patent litigation
• Growth product
• China: Nexium i.v. included in 2009 NRDL listing Strong growth in 2011NRDL listing. Strong growth in 2011 +38% CER
2626Product Performance
Iressa FY 2011 Sales: $554m +32% CER
400
500 EM ROW$221m +34%
• Western Europe +147%• Strong launch uptake• 80% of all 1st line EGFR M+ advanced
300
400
EST ROW
NSCLC patients receiving IRESSA• Emerging Markets +34%
• Including a 42% increase in China
100
200
W EUR
EST ROW$204m +2%
g• 1st line EGFR M+ approvals has been
granted in majority of Asian countries
0
100
FY 10 FY 11
W. EUR$127m +147%
US*$2m -50%
• Established ROW• 1st line EGFR M+ approval received in
Japan Q4FY 10 FY 11
US W EUR
EST ROW EM ROW
Japan Q4
272727
EST ROW EM ROW
*NDA withdrawn in the US Jan 2011Product Performance
FaslodexFY 2011 Sales: $546m +55% CER
Gl b l
400
500EST ROW$6m +100%
EM ROW$83m +28%
• Global• Value market share 60% (advanced
breast cancer hormonal market)
300
400W. EUR$193m +48%
• Faslodex 500mg now approved in 60 countries
• The conversion to the 500mg dose has been consistently successful across
100
200 US$264m +71%
been consistently successful across markets
• US & Western Europe together delivered 89% of global growth in 2011
0
FY 10 FY 11
of global growth in 2011• Established ROW
• Launched in Japan in Nov 2011FY 10 FY 11
US W EUR
EST ROW EM ROW
282828
EST ROW EM ROW
Product Performance
ONGLYZA Franchise: A new medication for type 2 di b t i i DPP4 l2 diabetes in a growing DPP4 class
• 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 20093 d DPP4 i hibit th EU k t- 3rd DPP4 inhibitor on the EU market
- Komboglyze (Onglyza & metformin IR FDC) – received marketing authorisation in Nov 2011
• Est ROW / EM: Further Launches in ROW during 2012
2929Onglyza and dapagliflozin are jointly developed and marketed by AstraZeneca and Bristol-Myers Squibb.Product Performance
DPP4 class growing globally and have now surpassed TZDs – DPP4's are now the leading BRANDED classTZDs DPP4 s are now the leading BRANDED classby value(~$6bn*) and volume
NIAD Class Global Volume NIAD Class Global Value (PDOT) Share (USD) Share
Metformin (MET), Sulfonylurea drugs (SU), thiazolidendiones (TZD), Dipeptidyl peptidase-4 inhibitors
303030Source: AstraZeneca and Bristol-Myers Squibb.
* Source: IMS Health MDART/MIDAS 3Q 2011 MAT.
( ), y g ( ), ( ), p p y p p(DPP4), alpha glucosidase inhibitors (AGI), Meglitinides (Glinide), Glucagon-like peptide-1 (GLP-1)
Product Performance
ONGLYZA FranchiseFY 2011 Global Alliance Revenue:
$211m +206% CEREM ROW
US• The ONGLYZA Franchise grew by 6.5 TRx share
points during 2011200
W. EUR$34m +240%
EST ROW$7m +250%
EM ROW$14m +367%
points during 2011• ~30% of US DPP4 market is FDC and ~ 1/3 of
new patients receiving a DPP4 & metformin FDC are given Kombiglyze XRK bi l XR h lift d O l
100
150$34m +240% • Kombiglyze XR success has lifted Onglyza
franchise share of new patients to ~25% in the DPP4 class
50
100EU
• Later launches stronger – e.g. in Greece, Norway, and Hungary, Patient Days of Therapy (PDOT)
l h b
0FY 10 FY 11
US$156m +189%
volume shares are above average
Est ROW / EM• LatAM: launch performance goodFY 10 FY 11
US W EUR
EST ROW EM ROW
p g• Launched in China Q4 2011 as the first DPP4
inhibitor
F th l d l h
313131
EST ROW EM ROW • Further approvals and launchesexpected during 2012
Product Performance
ONGLYZA Franchise – US market share performance
18%
Total Rx Share
16 45%
14%
16%16.45%
11 79%
17.20%
10%
12%
Rx
Shar
e
11.79%
11.67%
4%
6%
8%TR
5.53%
0%
2%
4% 4.66%
0%
01-0
1-11
02-0
1-11
03-0
1-11
04-0
1-11
05-0
1-11
06-0
1-11
07-0
1-11
08-0
1-11
09-0
1-11
10-0
1-11
11-0
1-11
12-0
1-11
Onglyza Kombiglyze XR Onglyza Family
323232
Source: IMS NPA Monthly data ending Dec 2012Onglyza jointly developed and marketed by AstraZeneca and Bristol-Myers Squibb.Product Performance
VimovoA d i US d EUApproved in US and EU
• 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 PhilippinesEstonia, Lithuania, Finland, Slovakia, Sweden, Switzerland, Philippines, New Zealand, Belgium, Spain, Austria, Italy and others) for Vimovo.
• Global revenue of $34m in 2012• Global revenue of $34m in 2012
• US- VIMOVO performance to date reflects the challenges of launching aVIMOVO performance to date reflects the challenges of launching a
branded product into a highly genericised US market• EU
- Majority of launches occurred in 2011Majority of launches occurred in 2011- Launch will follow pricing and reimbursement procedure for each
country • Row
3333
- New launches during 2012 in Brazil, Mexico, Russia and Australia
Product Performance
VimovoA d i US d EUApproved in US and EU
Over 151 Million People Suffer From Osteoarthritis Pain1Over 151 Million People Suffer From Osteoarthritis Pain1
Low Satisfaction GI RiskUp to 30% of OA patients
switch or augment therapy in a year, mainly due to efficacy
d id ff 2
More than 50% of OA patients on chronic NSAIDs are at GI Risk4
~1 in 4 OA patients on NSAIDs
Non Adherence
and side effects2 are co-prescribed a PPI3
Non-AdherenceUp to 60% of patients are non-compliant with co-Rx
1W ld H lth O i ti Gl b l B d f A th iti 2004
pGPA5
343434
1World Health Organisation, Global Burden of Arthritis, 20042Adelphi Arthritis US VI DSP, 20093Adelphi Arthritis US VI DSP, 20064Sources: Us, EU4, Canada & Mexico Rxs, MAT 06/09. US Data: IMS LRx model, EU4 data: Cegedim EMR longitudinal data, Mexico & Canada – IMS Detailed Medical Database, Midas5Sturkenboom 2003
Product Performance
Vimovo P OA i li f ith b ilt i t t tiProven OA pain relief with built-in gastroprotection
• Approval based on studies 301 and 302, which demonstrated :
Demonstrated Significant Risk Reduction in Endoscopic GUs at 6 Months
302, which demonstrated :
- Significant endoscopic gastric ulcer risk reduction vs. EC
23.10% 24.30%
20%
25%
30%
ce
82% RR 71% RR
naproxen
- Gastric ulcers reduced even in 7.10%10%
15%
20%
GU
Inci
den
p<0.001 p<0.001
presence of low dose aspirin
- Significantly lower rate of
4.10%7.10%
0%
5%
PN400218
EC-Nap216
PN400210
EC-Nap210discontinuation due to UGI AEs
(including DU) vs EC naproxenn=218 n=216 n=210 n=210
PN400-301 PN400-302
3535Product Performance
BRILINTA/Prevalence of Acute Coronary Syndromes (ACS)(ACS)
~3 5 million >1 4 million About every 3.5 million >1.4 million episodes of ACS reported in the
Hospitalisationsfor ACS in the US
y26 seconds, an
American will suffera coronary eventp
major 7 markets (EU*, US, Japan) in
2005
CS USin 2005
About every minute, an American will diean American will die
from a coronary event
363636
1. Decision Resources Pharmacor Reports (STEMI, July 2006; NSTEMI/UA, July 2005).2. Rosamond W, et al. Circulation. 2008;117:e25-146.
*France, Germany, Italy, Spain, and United Kingdom.
Product Performance
The ACS opportunity
373737
Source: Kantar Health EpiDatabase except for Germany, which sources from Decision Resources. 2011 estimates of incidence
BRILINTA – Launch & Regulatory Status
Approved in 64 Markets Under Review in >30 MarketsLaunched* in 37 Markets* commercially available
3838Product Performance
As of 31st of Jan
y
Reimbursement in 20 Markets (+4 patient pay markets)
BRILINTA – Launch & Regulatory Status
Regulatory Approvals
Commercial Launch
Pricing & Reimbursement
Formulary / Protocol Access
BRILINTA BRILINTA BRILINTA BRILINTA BRILINTA regulatory
approval in 64 countries with
labels reflective of
BRILINTA commercial
launches in 37markets
reimbursement in 20 markets and 4
patient pay markets
formulary/protocol access varies by
country
the PLATO trial.
Provides access to 58% of global incident ACS
Provides access to 45% of global incident ACS
Provides access to 38% of global incident ACS
Provides access to 12% of global incident ACS incident ACS
population population population population
3939Product Performance
As of 31st of Jan
BRILINTA PLATO study
(N 18 624)UA/NSTEMI (moderate–high risk); STEMI (if primary PCI)
(N=18,624)All receiving ASA; clopidogrel-treated or naïve;randomised within 24 h of index event
ClopidogrelIf pretreated, no additional ld;if naïve standard 300-mg ld
AZD6140 (BRILINTA)180-mg ld, thenif naïve, standard 300-mg ld,
then 75-mg od maintenance;(additional 300 mg allowed pre-PCI)
90-mg bd maintenance(additional 90 mg allowed pre-PCI)
Primary end point: CVD/MI/stroke – patients intended for invasive management
6-12-month exposure
Primary end point: CVD/MI/stroke patients intended for invasive managementSecondary end point: CVD/MI/stroke/recurrent ischaemia/TIA/other arterial
thrombotic events
404040
PLATO = A Study of PLATlet Inhibition and Patient Outcomes.
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 anginaProduct Performance
BRILINTA – Reduction in CV death, MI or stroke
4141
K-M = Kaplan-Meier Source: AZ US promotion material based on Plato studyProduct Performance
BRILINTA – Reduction in CV death
4242Product Performance
Source: AZ US promotion material based on Plato study
BRILINTA - Primary Efficacy Outcome ASA M i t D
16 Tic: ASA High
Maintenance Dose
14
12
e (%
)
Cl ASA Hi h10
8mate
d r
ate Clop: ASA High
Tic: ASA Low
Clop: ASA Low
8
6
Meie
r esti
m
4
2
ASA L ( 300 )
Kap
lan
-M
0 60 120 180 240 300 360
0ASA Low (< 300 mg) : HR (95% CI), 0.79 (0.71, 0.88)
HR (95% CI), 1.45 (1.01, 2.09)ASA High (> 300 mg) :
434343
Days from randomisation
0 60 120 180 240 300 360
Product Performance Source: Plato study
BRILINTA Pegasus StudyF th i ti ti th t ti l f BRILINTAFurther investigating the potential of BRILINTA• Current treatment guidelines for acute coronary syndrome (ACS) patients recommend
dual anti-platelet therapy for up to twelve months post-eventdual anti-platelet therapy for up to twelve months post-event• The PEGASUS-TIMI 54 study will examine the long-term efficacy and safety of ticagrelor
in patients who have sustained a heart attack from one to three years prior to enrolment • Trial Design:• Trial Design:
- Randomised, double-blind, parallel-group study- 21,000 patients worldwide
In addition to ticagrelor or placebo, patients will take once-daily, concomitant aspirin therapy (75 to 150 mg)therapy (75 to 150 mg)
Minimum treatment duration of 12 months
• The primary efficacy endpoint will be time to first occurrence of any cardiovascular event including CV death, non-fatal myocardial infarction or non-fatal stroke
• Data expected 2014
4444
Data expected 2014
Product Performance
R&D&
R&D
How are we addressing the R&D productivity h ll ?challenge?
Leadership and operating model1 Leadership and operating model1.
Attrition analysis and portfolio review2.
Organisational footprint3 Ongoing*Organisational footprint3.
Ongoing
Ongoing
Capability build and external science4.
4646R&D * Further restructuring announced 2nd of Feb
1. One R&D organisation
Di d l d l t L t t D l tDiscovery and early development Late-stage Development
Internal and
Global Medicines
Development
Innovative MedicinesInnovative MedicinesUnitsUnits
Marketand
external opportunities
InnovativeInnovative
p
Innovative Innovative MedicinesMedicines
UnitsUnits
R&D Enabling functions
474747R&D
2. Changing therapy area focusBuild / Maintain Deprioritise
484848R&D
2. Stringent Selection Criteria
• Link between target / disease• Predictive biomarkers
Right target engagementRight target engagement
Right tissue exposure • Bioavailability and tissue exposureH PK/PD di ti• Human PK/PD prediction
• Differentiating safetyRight safetyRight safety
Differentiating safety• Reactive metabolites
Right patientsRight patients • Scientific evidence in lead indication• Stratification of patient population
Right commercialRight commercial• Differentiated value proposition• Embedded payer perspective
494949R&D
2. Significant changes to the pipeline
sof
pro
ject
sN
umbe
r
505050R&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.
Small moleculesBiologics
3. Our R&D 2011 footprintBiologics
*Sodertalje, Sweden
Molndal, SwedenAlderley, UKSt Petersburg, Russia
San Francisco, CA*Montreal, Canada
Boston, MAWilmington, DE
Gaithersburg, MD
,Cambridge, UK
Reims, France
Osaka, Japan
Bangalore, India
Shanghai, China
• Global R&D Network
• Reducing Geographical footprint & Headcount
515151
l
g g p p
• Broader Technology baseR&D *Announcement 2nd of Feb-Exit all R&D operations
4. Investing in new capabilities to enhance productivity
Clinical trial designand interpretation
Integrated payerstrategy
Personalisedhealthcare
Predictivesciences
5252R&D
Portfolio highlights 2010/2011Launched/Approved Submitted New Indications Phase 3/LCM Starts
JapanEurope Europe
TC-5214
F t ti ib
Further Markets
Europe, USA, Japan& China. (500 mg)
Europe
Dapagliflozin Europe & USA
Fostamatinib
NKTR-118US, CAN, Brazil
Europe & USA(PUB) China
Europe & USUS
CAZ- AVI
1st Line NSCLC Japan
US & Europe Japan
Russia
PegasusLCM1 Line NSCLC Japan
EuropeEurope
LCM
MEDI-3250
US
5353R&D
China & other MarketsEU
Late stage Projectsate stage ojects
R&D
Pipeline FY 2011- NCEs Phase III/RegistrationCompound Mechanism Area Under
InvestigationPhase Estimated Filing
CardiovascularBrilinta/Brilique ADP receptor antagonist arterial thrombosis III Launched Launched 1H 2013 LaunchedDapagliflozin# SGLT2 inhibitor diabetes III Filed** Filed 1H 2013 Filed
InvestigationUS EU Japan Emerging
TC-5214# neuronal nicotinic channel modulator
major depressive disorder (adjunct)
III 3Q 2012 2015
NKTR-118# oral peripherally-acting opioid antagonist
opioid-induced constipation
III 2H 2013 2H 2013
Neuroscience
opioid antagonist constipation
Oncology
Caprelsa(vandetanib)
VEGFR/EGFR tyrosine kinase inhibitor with RET kinase activity
medullary thyroid cancer
III Launched Filed 2014 Filed
Infection
kinase activityRanmark#
(denosumab)anti-RANKL Mab bone disorders
stemming from bonemetastasis
III Approved
Q-LAIV Flu Vac(MEDI-3250*)
live, attenuated, intranasal influenza virus vaccine(quadrivalent)
seasonal influenza III Filed 4Q 2012
Zinforo#
(ceftaroline)extended spectrum cephalosporin with affinity to penicillin binding
pneumonia/skin infections
III Filed 3Q 2011
Respiratory & Inflammation
to penicillin- binding proteins
CAZ-AVI#
(CAZ-104)beta lactamase inhibitor/cephalosporin
serious infections III 2014 2014 2014
5555#Partnered product, *sBLA in US, MAA in EU, ** CRL received in Jan 2012R&D
Fostamatinib# spleen tyrosine kinase(SYK) inhibitor
rheumatoid arthritis III 2H 2013 2H 2013 2H 2013
Diabetes: A growing global problemType 2 Diabetes prevalence expected to grow from 285m to 438m by 2030
50-70% of patients are not controlled
Europe prevalence is 6.9% with highest rates (>11%) in
Germany, Austria,
Diabetes growing rapidly in U.S. – current prevalence
rate 10.3% y, ,Switzerland, and Portugal
Brazil’s prevalence will increase by two-
thirds by 2030
India and China will comprise nearly 33% of the world’s total patients with diabetes in 2030y patients with diabetes in 2030
565656Source: WHOCVGI
The progressive nature of Type 2 Diabetes lti t l h l di tiultimately overwhelms medications
Glycemic Control in an Illustrative Patient
Potential treatment
Goal*
changeFirst
Agent
Goal*A1c=<7
Goal**
HbA
1c
Normal***
A1c=<6.5
A1c=5%~30 Years
575757
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 NIHCVGI
Dapagliflozin: new approach to diabetes
Submitted in US and EU SGLT2 i hibiti
N l i li i d d t
Submitted in US and EU in Dec 10
SGLT2 inhibition
• Novel insulin independent mechanism and site of action
• Potential benefit in uncontrolled patients with type 2 diabetes who require HbA1c reduction and the additional benefit of weight loss
• Effective at all stages of thedisease and with widely usedanti-diabetic medications
Glucose excretionenabled throughSGLT2 inhibition
anti-diabetic medications
5858Dapagliflozin is being jointly developed and marketed by AstraZeneca and Bristol-Myers Squibb.CVGI
Dapagliflozin – Regulatory statusDapagliflozin FDA advisory committee outcome in July• Dapagliflozin FDA advisory committee outcome in July 2011, 6 Yes and 9 No, but acknowledged the need for new treatment options
• In Oct 2011, FDA extended the Prescription Drug User Fee Act (PDUFA) date for dapagliflozin by three months to January 28, 2012
• A complete Response Letter was issued 19th of Jan by the FDA regarding the New Drug Application for dapagliflozin
• The complete response letter requests additional clinical data to allow a better assessment of the benefit-risk profile for dapagliflozin. This includes clinical trial data from ongoing studies and may require information from newongoing studies and may require information from new clinical trials
• AstraZeneca and Bristol-Myers Squibb will work closely y ywith the FDA to determine the appropriate next steps for the dapagliflozin application and are in ongoing discussions with health authorities in Europe and other countries as part of the application procedures
5959
countries as part of the application procedures
Dapagliflozin is being jointly developed and marketed by AstraZeneca and Bristol-Myers Squibb.CVGI
Dapagliflozin: A comprehensive phase 3
Diet and exerciseent
m
programme
Monotherapy Oral anti-diabetic medication(s)
Oral anti-diabetic medication plus insulin
Insulin alone
T2D
trea
tme
para
digm
• Monotherapy• Initial combination
with Metformin
• H2H vs. SU • Add-on Metformin• Add-on SU
Add TZD
• Add-on insulin +/- OAD
ifloz
inst
udie
s
• Add-on TZD• Add-on DPP4 (IIIb)
• Special Patient Populations (Renal/CV) & Special Investigations (body composition)
Dap
agli
clin
ical
s
• 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• Data from 2 further studies (H2H vs. SU, add-on to SU) presented at EASD 2010• 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.
606060
• FDA advisory committee held on the 19th of July 2011
Onglyza and dapagliflozin are jointly developed and marketed by AstraZeneca and Bristol-Myers Squibb.CVGI
Major Depressive Disorder (MDD) is a highly prevalent & debilitating disease with significantprevalent & debilitating disease with significant levels of unmet need
million people worldwide affected by major depressive disorder143
2nd leading cause of disability in ages 15 to 44 2
18 million patients are treated with drugs from a18 p gdiagnosed population of 23 million globally 1
don’t achieve remission after two sequential medications over a six months period344%
616161
1 – Decision Resource Cognos Report August 2009 , 2 - WHO website key facts on Depression, 3 – Ref 2. Rush et al, Am J Psychiatry 2006; 163:1905–1917 Derived from steps 1 and 2, 56.1 patients (36.8+19.3)
are remitters; 43.9 are non-remitters (44%)Neuroscience
TC-5214: opportunity in MDD
Phase 3 RENAISSANCE i
TC-5214 Phase 2b adjunct study demonstrated clinical efficacy in MDD -programme ongoing
• Exciting Phase 2 results where
0
-2rom
t
PBO + CITTC-5214 + CIT
demonstrated clinical efficacy in MDD improving over duration of trial
TC-5214 demonstrated clinical efficacy in MDD
• The Phase 3 RENAISSANCE **
-4
-6
M-D
Sco
re fr
ed tr
eatm
ent
Impr
** p < 0.01P < 0.0001***
clinical program will sequentially readout from Q4 2011 untilQ2 2012
**
**
-8
-10
hang
e in
HA
Mof
rand
omis
e rovement
• Filings planned in the US in 2H 2012 and in the EU in 2015
*****
-12
-
Mea
n ch
star
t o
*HAM-D = Hamilton depression Score
Week since randomisation1 2 4 6 814
-16
6262Neuroscience
TC-5214 Key Milestones 2011 2012 2013 2014 2015
USMDD Adjunct
PLANNED
H2
Renaissance 2 (Flex)
Renaissance 3 (Flex)
Renaissance 4 (Fixed)PLANNED
SUBMISSION Renaissance 5 (Fixed)
Renaissance 7 (LTS)
EU/RoWMDD Adjunct
Additional studies to meet EU regulatory requirements:Long term efficacy, Elderly PLANNED
SUBMISSIONSUBMISSION
Monotherapy Phase II trial H2PHASE III DECISION
636363
POINT
Neuroscience
TC-5214: Phase 3 RENAISSANCE ProgramRENAISSANCE 2 RENAISSANCE 3 RENAISSANCE 4 RENAISSANCE 5 RENAISSANCE 7
S fStudy design Flexible dosing Flexible dosing Fixed dosing Fixed dosing Long term safety
Geographic location US and India Europe US and India Global
(no US or India) US
Planned number of patients to be screened
940 940 2234 2236 2000
Target number of evaluable patients 288 288 684 684
At least 300 for 6 months & 100 for
1 year
Dose
1-4mg TC-5214 BID or placebo 1-4mg TC-5214
BID or placebo0.5 mg, 2 mg or 4 mg TC-5214 BID or placebo
0.1 mg, 1 mg or 4 mg TC-5214 BID or placebo
1-4mg TC-5214 BID or placebo
ClinicialTrials.gov identifier NCT01157078 NCT01180400 NCT01153347 NCT01197508 NCT01152554
RENAISSANCE 3 & 2: Top line data announced on the 8th of Nov and 20th of Dec
6464
RENAISSANCE 3 & 2: Top line data announced on the 8 of Nov and 20 of Dec.The studies did not meet their primary endpoints of change on the Montgomery-Åsberg Depression Rating Scale (MADRS) after eight weeks of treatment with TC-5214 as compared to placebo
Fostamatinib – Rheumatoid Arthritis• Fostamatinib is:
- the first oral spleen tyrosine kinase inhibitor in development as a potential treatment for RA- thought to reversibly block signaling in multiple cell types involved in inflammation and tissue
degradation in RA
• 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• 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
6565
1- 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; 363:1303-1312Inflammation
Rheumatoid Arthritis is a prevalent & debilitating di ith i ifi t l l f t ddisease with significant levels of unmet need
illi l ld id ff d b RA120 million people worldwide affected by RA1209 Million RA patients treated with disease-modifying therapy
(traditional and biologic)2,3
7 Million RA patients (approx. 80%) do not achieve remission with a traditional disease modifying anti-rheumatic drug (DMARD)
Million RA patients are treated with biologic therapy following
7 alone4
3Million 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)
6666
1 WHO report: The global burden of rheumatoid arthritis in the year 2000 http://www.who.int/healthinfo/statistics/bod_rheumatoidarthritis.pdf2 Decision Resource Pharmacor 2010 , 3 IMS Health MIDAS sales database4 Blumberg SN, Fox DA. Rheumatoid arthritis: guidelines for emerging therapies. Am J Manag Care 2001 ; 7 (6): 617 -26Inflammation
Fostamatinib opportunity in RA
Target PopulationTarget PopulationPatients who have an inadequate response to traditional disease-modifying anti-rheumatic drug
(DMARD) therapy
Profile in phase III d i RA i i h
Improved patient QoL• Improved outcomes in RA patients with
methotrexate background treatment, as measured by ACR and DAS
• Fast onset of action - 36% of patients
• Oral formulation
• No administration pain as associated withpachieved a response within 1 week
• Initial evidence of preventing further bone and cartilage damage
No administration pain as associated with injected therapy
• No need to visit hospital / physiciansffi f i f i• Manageable safety and tolerability profile office for infusions
676767Inflammation
Fostamatinib demonstrates efficacy in RA patients with inadequate response to methotrexateinadequate response to methotrexateRobust TASKi2 phase 2b trial reproduces ‘anti-TNF like’ efficacy seen in phase 2a
Placebo Fostamatinib 150 mg po qd Fostamatinib 100 mg po bid
686868
acebo osta at b 50 g po qd osta at b 00 g po b d
InflammationRef: 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
Fostamatinib phase 3 development planThe phase III programme, OSKIRA, is designed to investigate fostamatinib as a treatment
for RA in patients with an inadequate response to DMARDs, including methotrexate
NDA & MAA 2013FPI Sept 2010
MTX-IR, 12 month MTX combination, n~ 900MTX combination, n 900
DMARD-IR, 12month DMARD combination, n ~ 900
aTNF-IR, 6 month MTX combination, n~ 450
LONG-TERM EXTENSION n~ 2100 (incl. 500 ex PhII)( )
Monotherapy (Phase IIb), 6 monthDMARD naiive and IR, n ~ 250
(began Q1 2011)
Japanese Phase I study
(US)
Japanese Phase I study
(US)
( g Q )
696969Inflammation * First data available late 2012 / early 2013
NKTR-118: Opioid Induced Constipation (OIC)OIC is a common and potentially debilitating adverse effect associated withopioid analgesic use
250 illi i id i ti itt f t t t f t d h i i- 250 million opioid prescriptions were written for treatment of acute and chronic painin 2010 in the United States alone1
- For those patients who take opiates for long term pain management, approximately 40 50 percent will develop constipation240-50 percent will develop constipation2
- Only about 40-50 percent of those patients experience effective relief from the current treatment options that include prescription and over-the-counter laxatives and stool softeners3,4,5.softeners .
• NKTR-118 is an oral peripheral mu-opioid antagonist , under investigation for the treatment of opioid-induced constipation (OIC). It is designed to relieve OIC without impacting pain reliefimpacting pain relief.
NKTR-118 is part of the exclusive worldwide license agreement announced on September 21, 2009, between AstraZeneca and Nektar Therapeutics.2009, between AstraZeneca and Nektar Therapeutics.
1 IMS MAT. December 2010.2 Thomas, J. Opioid-Induced Bowel Dysfunction. Journal of Pain and Symptom Management. 2008;35(1):103-113.3 Bell T et al OBD symptoms impair quality of life and daily activities regardless of frequency and duration of opioid treatment:
707070
3 Bell, T et al. OBD symptoms impair quality of life and daily activities, regardless of frequency and duration of opioid treatment:results of a U.S. patient survey (PROBE survey). Poster presented at The 25th Annual Scientific Meeting of the AmericanPain Society.San Antonia, TX, USA.
4 Pappagallo, M. Incidence, prevalence, and management of opioid bowel dysfunction. Am J Surg. 2001:182;S11-S18.5 Fakata, K. Peripheral Opioid Antagonists: A Therapeutic Advance for Optimizing Opioid Gastrointestinal Tolerability. The Journal of
Family Practice. 2007;56:S1-S12.Neuroscience
NKTR-118 significantly increases the frequency f t b l t d dof spontaneous bowel movements and reduces
time to first SBM in phase 2 studiesChange from Baseline in Spontaneous
Bowel Movements (SBMs/week)Median Time (hrs)
to First SBM
548.6
44.950
60
SBM
P < 0.002P = 0.001NS
(SE)
P = NS P = 0.002 P = 0.0001
2 6
3.64.4
2
3
4
5
28.2
20
30
40
(hrs
) to
Firs
t S
hang
e in
SB
M
1.8 1.9 1.92.6
0
1
2
6.2 6.62.9
0
10
20
5 25 50Ti
me
(Ch
5mg 25mg 50mg 5 mg 25 mg 50 mg
P-values based on a log rank test
Placebo NKTR-118 Placebo NKTR-118
Week 1 of DB Treatment
5mg 25mg 50mg
717171
gP-values based on a Wilcoxon Test
Webster L et al. ACG 2009Neuroscience
NKTR-118: KODIAC - Ongoing Phase 3 Program
• The Global Phase 3 Program* Commenced ingMarch 2011- Two 12-week, randomized, placebo-controlled efficacy
studies (N=630 per trial) with One 12-week Extensionstudies (N 630 per trial) with One 12 week Extension study (N=633)
- An open-label, randomized, long term safety studywith a usual care comparator arm (N=1135)with a usual care comparator arm (N=1135)
- One efficacy study in patients with cancer related pain (N=340)
• AZ responsible for the full development of NKTR-118 including clinical, regulatory, CMC and commercialization activities
• Health Authority filings planned by AZ in 2013
727272
*Clinicaltrials.gov ref: NCT01323790 , NCT01309841, NCT01384292, NCT01336205, NCT01395524
Neuroscience
Caprelsa (vandetanib) –Approved for treatment f d d d ll th idof advanced medullary thyroid cancer
• Thyroid cancer is a rare form of cancer. MTC represents 5 to 10% of total thyroid cancer cases About half of MTC patients have locally advanced and/or metastaticcancer cases. About half of MTC patients have locally advanced and/or metastatic MTC (aMTC).
- US - estimated 45,000 new thyroid cancer cases each year, up to 2000 new MTC patients a year
- Europe - thyroid cancer affects approximately 48,000 individuals annually, with an estimated mortality rate of 6,300 patients each year (GloboCan 2008)
• FDA approval on the 6th of April 2011 - only medicine to receive FDA approvalFDA approval on the 6th of April 2011 only medicine to receive FDA approval specifically for use in patients with advanced medullary thyroid cancer and brought to market under Orphan Drug Designation in the US
• Caprelsa significantly improved progression free survival in patients with medullary thyroid cancer (MTC) in the ZETA phase 3 trial
- Data presented at ASCO 2010p
• Received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in Q4 2011
7373Oncology
Anti-Infective portfolio that coversb d t f t itia broad spectrum of opportunities
R i t t G + G + R i t t GG
Spectrum of Activity
Resistant Gram+ Gram+ Resistant Gram–Gram–
MRSA S i H. influenzae ESBL PMRSAMDRSP
S. pneumoniaeS. aureus
H. influenzaeE. coli
K. pneumoniaeProducing
Gram–
P. aeruginosa
Ceftaroline
Ceftaroline + NXL104
CAZ AVI
747474Infection
Zinforo (ceftaroline): A next generation h l i tibi ticephalosporin antibiotic
• Phase III programme targeting:- Complicated skin and soft tissue infections (cSSTI)- Community-acquired pneumonia (CAP)- Community-acquired pneumonia (CAP)- Demonstrates bactericidal activity against a broad range of pathogens
commonly implicated in cSSSI and CAP, including methicillin-resistant Staph aureus (MRSA) and penicillin-resistant Strep pneumoniae (PRSP)Staph. aureus (MRSA) and penicillin resistant Strep. pneumoniae (PRSP)
• Collaboration with Forest Laboratories started August 2009- AstraZeneca to co-develop and commercialize in all markets outside
US/Canada/Japan- Financial terms not disclosed
7575Infection
Complicated skin and soft tissue infections ( SSTI) d it i d i(cSSTI) and community acquired pneumonia (CAP)
cSSTI CAP
767676Infection
Zinforo: A next generation cephalosporin tibi tiantibiotic
Submitted in EU Dec 10 1o
Endpoint
• Demonstrated good
Non-inferiority
-10 0 10 20
Response (% Difference)
Endpoint10% NI margin
Population
efficacy in Phase 3 cSSTI and CAP
• Differentiating attributes
CANVAS 1
cSSTI
Modified intent-to-treat
Clinically evaluable
Modified intent-to-treat 1.2• Differentiating attributes- extended spectrum coverage, incl. MRSA activity in skin, coupled
CANVAS 2
FOCUS 1
Clinically evaluable
Clinically evaluable
Modified intent-to-treat
activity in skin, coupled with a favourable tolerability profile FOCUS 2
CAPClinically evaluable
Modified intent-to-treat
Clinically evaluable
Favours Zinforo
Favours Comparator
7777Infection
CAZ AVI: to overcome antibiotic-resistance and treat the increasing number of infections resistant to existingincreasing number of infections resistant to existing therapies• Globally over 1m patients a year suffer from infections known or suspected toGlobally, 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 decadeCAZ AVI combines a broad spectrum cephalosporin (ceftazidime) and a novel• CAZ-AVI combines a broad-spectrum cephalosporin (ceftazidime) and a novel 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 Intra-Abdominal Infections (cIAI) and Complicated Urinary Tract Infections (cUTI)
• The trial programme is designed to support global regulatory filings in 2014 p g g pp g g y gand will include five Phase III trials, based on positive results from twoPhase II trials
• In the collaboration development costs will be shared between AstraZenecaIn the collaboration, development costs will be shared between AstraZeneca 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
7878
AZ has rights to commercialise CAZ AVI in rest of world
Infection
Phase 3 development decisions
Area under investigationAssets
AZD1981 (CRTh2 t t i t)
Breast cancer/Solid tumours
Asthma / COPDAZD1981 (CRTh2 receptor antagonist)
AZD8931 (erbB kinase inhibitor)
NSCLC / S lid t
Severe sepsis
AZD6244 – Selumetinib
AZD9773 (anti-TNF-alpha polyclonal antibody)
NSCLC / Solid tumours
Polymicrobial infections
(MEK inhibitor)
CXL(beta lactamase inhibitor and cephalosporin)
Solid tumours
Glioblastoma
MEDI1123 – Tremelimumab(CTLA-4 monoclonal antibody)
MEDI575 (anti PDGFR alpha mAb) Glioblastoma
New target Follower
MEDI575 (anti-PDGFR-alpha mAb)
7979R&D
Phase 3 development decisions: 1 example
Assets
AZD1981 (CRTh2 t t i t) Unmet medical needAZD6244 – selumetinibAZD1981 (CRTh2 receptor antagonist)
AZD8931 (erbB kinase inhibitor)
Unmet medical need
Asthma with allergic component
Non-small cell lung cancer
MEK i hibit
AZD6244 – Selumetinib
AZD9773 (anti-TNF-alpha polyclonal antibody)
Breast cancer
Asthma with allergic component• MEK inhibitor• Leading cause of cancer mortality• 25% have KRAS mutation and poor
prognosis(MEK inhibitor)
CXL(beta lactamase inhibitor and cepholasporin)
Breast cancer
Severe sepsis
prognosis• Phase 2: Significant improvement in
Progression-free survival • Trend for improvement in overall survival
MEDI1123 – Tremelimumab(CTLA-4 monoclonal antibody)
MED575 (anti PDGFR alpha mAb)KRAS mutation non-small cell lung
p• Trend for improvement in overall survival
New target Follower
MED575 (anti-PDGFR-alpha mAb)
8080R&D
Strategy Update & Planning Assumptions 2012+
Planning Assumptions81
Corporate Strategic priorities Making the
most meaningful difference to patient healththrough great medicines
Increase output • Innovation• Growth of current
Deliver the business
• Implement asset
BusinessShape
PeoplePipeline
• Increase output
• Drive productivity& efficiency- Disease area focus
Innovation
• Accountability
• Lean & agile
Growth of current products
• Successfully launch the new products
Implement asset strategy & LEAN
• Drive efficiencies in Sales & Marketing
d G&A- Reduce site footprint
• Collaboration- Externalisation- Build stronger
l ti hi
• Value orientation• Drive growth in emerging markets
• Develop innovative
and G&A
• Focus Capexon productivity improvements
relationshipwith payers
Manage for long term shareholder value
pchannels to meet customer needs
p
Our values
Manage for long-term shareholder value
828282Planning Assumptions
Key planning assumptions remain robust
• Pharma sector can grow at least in line with real GDP,hi h ill th l i h iwhich will grow over the planning horizon
• Downward pressures from government interventions in the marketplace increased in 2011increased in 2011- Do not, as yet, represent a sustained “step-change” in evolution of these
pressures
• AstraZeneca assumptions- No material M&A or disposals
• Astra Tech sale in Q3 2011Astra Tech sale in Q3 2011- No premature loss of market exclusivity for key products- No material change in Fx rates for principal currencies vs average
January 2010 ratesy• Euro has significantly weakened vs USD
8383Planning Assumptions
Guidance for 2012 (Core basis)
Revenue Low double-digit decline at CER
Gross Margin Below 2011, but above 80%
Core Pre-R&D Margin Below 2011, but upper half of mid-term planning range (48%-54%)
Net Finance Expense In line with 2011
Other Operating Income Low double-digit decline vs 2011
Tax Rate Reported tax rate around 24%
Core EPS Range $6.00 to $6.30
8484Planning Assumptions
Currency basis for 2012 guidance
• Currency: January 2012 average rates:- $1 = £ 0.645
$1 = EUR 0 775- $1 = EUR 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 atwww.astrazeneca.com
8585Planning Assumptions
Estimated impact of currency movementsl d ion sales and earnings
Estimated impact of a 10% appreciation of the respective currency against the USD
EUR 1 9% 3 5%
Sales Core earnings
EUR 1.9% 3.5%
GBP 0.2% -2.2%
SEK 0 1% -2 6%SEK 0.1% 2.6%
JPY 1.1% 1.4%
Other Currencies 2.7% 4.9%% %
TOTAL 6.0% 5.0%
868686Planning Assumptions
Planning Assumptions 2010-14: UpdateG th B i• Grow the Business
- Revenue in the range of $28bn to $34bn per annum over the period• Centre of gravity lower half of range going forwardg y g g g
- Risk adjusted revenue contribution from the recently launched and pipeline products lowered to the range of $2bn to $4bn
• Reshape the business- Maintain gross margin >80%
C & f- Core Pre-R&D operating margin in the range of 48-54 percent- Restructuring programmes on track. Phase 3 announced 2 Feb 2012
• Cash generation and investment- Achieving revenues and margins within planning range will drive
strong cash flowstrong cash flow- Reinvest 40 to 50% of after tax pre-R&D cash flow to drive future
growth and valueC h t t h h ld i i di id d d i di
8787Planning Assumptions
- Cash returns to shareholders via progressive dividend and periodic share repurchases
Deliver the business
Planning assumptions2010-2014Strategic Initiatives
• Grow market share of key brands that retain exclusivity:- Crestor- Seroquel XR
• Revenue in the range $28bn-$34bn per
th i dq
- Symbicort
• Successfully commercialise recent launchesand the next wave*
annum over the period
• Centre of gravity lower half of the range going and the next wave
- ONGLYZATM
- BRILINTA- Vimovo
- NKTR-118- TC-5214- Zinforo (ceftaroline)
g g gforward
• Risk adjusted contribution of $2bn-
- Caprelsa (vandetanib)- Dapagliflozin
( )- CAZ AVI- Fostamatinib
contribution of $2bn-$4bn from the recently launched and pipeline products
• Sustain double digit growth in emerging markets- Drive growth and new launch portfolio- Broaden portfolio to include branded generics
• Emerging Markets business ~25% of revenue in 2014
888888
Broaden portfolio to include branded generics
* Updated to reflect recent pipeline changesOnglyza and dapagliflozin are jointly developed and marketed by AstraZeneca and Bristol-Myers Squibb.Strategy
Business shape
Strategic Initiatives Planning assumptions2010-2014
• Maintain gross margin >80%- Complete asset strategy & API outsourcing- Drive LEAN SigmaDrive LEAN Sigma
• Improve Sales & Marketing effectiveness and efficiency- New channels and approaches
Core pre-R&D operating margin in the range of
48-54%
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
898989
Focus on working capital management
Strategy
Driving ROI from R&D
Returns periodInvestment period
• Function costs
• Site footprint
• Supply chain capacity
• Sales and Marketing (mature markets)
N t f i l
Reduce
• Non-customer facing roles
• New talent • New commercial channels
Invest/Innovate
New talent
• Critical capabilities
New commercial channels
• Emerging Markets- Sales and Marketing
Manufacturing
9090
• Externalisation- Manufacturing
Cash generation & Investment
B i f hReinvest 40 to 50% of
ft t R&D h fl R id l h flBusiness focus on cash flow generation
after-tax pre-R&D cash flow to drive future growth
and value
Residual cash flowavailable for
• Specific business needs
• Debt repayment
• Internal and external R&D
• Tangible assets and information technology
• Achieving revenue and Core pre-R&D margins in planning range
• Progressive dividend policy
• Share repurchases
information technology• Delivering restructuring
programmes
• Tight management ofTight management of working capital, tax & interest
919191Strategy
2010-2014 in summary…
Reinvest 40 50%
Pre-R&D post tax
Marketed Products 40-50%
Pre-R&D
pcash flow
Revenue$28-34bn
Pre R&D Margin48 54%
Pre-R&D post tax
Other business
Margin48-54%
$ 48-54% post tax cash flow
W ki it l T &
business needs &
debt service
Working capital, Tax & interest management
Shareholder distribution
9292Planning Assumptions
2011 Strong Cash Generation: Use of Cash
$bn, Act RoX
1840% Reinvestment Rate $9.4bn Return
1.8AstraTech
14
16
183.3
1.1
to Shareholders
11.110
12
1.13.8
6
85.6
3.7
2
42.8
8.3
02011
Opening Net Cash
Pre R&D Post tax
cash flow
After tax R&D*
Capex Dividends Net SBB 2011 Closing
Net Cash
9393
93 * R&D includes internal R&D expenditures, net of tax and depreciation/amortisation,and externalisation.
Shareholder Distributions• Progressive dividend policy
- Maintain or grow dividend each year
Annual dividend to reflect earnings prospects over entire cycle not just one year in isolation &- Annual dividend to reflect earnings prospects over entire cycle, not just one year in isolation & cover may vary, with target of an average of 2-times cover (ie 50% payout ratio) over the cycle, based on reported earnings (before restructuring)
• Dividend for 2011: $2 80 vs $2 55 2010 (+10%)• Dividend for 2011: $2.80 vs $2.55 2010 (+10%)- Second interim dividend 2011 $1.95
• Distribution policy and financial strategy to balance needs of business i t t fi i l dit d h h ldinvestment, financial creditors and shareholders
• The Board to keep under review the opportunity to return surpluscapital 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
• Net cash distributions to shareholders 2011 - Increased by +71% to $9.4bn 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
949494Planning Assumptions
Restructuring Programme: Phase 1 Complete 2007 20092007-2009
ProgrammeCost
2007-2009 $m
HeadcountImpact
2007-2009
Annualbenefits2010 $m
Global Supply Chain 4,250 (1,003)
SG&A 6,750 (1,216)
R&D 1,600 (288)
Total 12,600 (2,506) 2,400
959595Strategy
Restructuring Programme: Phase 2 Complete 2010 20112010-2011
HeadcountImpact
ProgrammeCost
Annualbenefits
Global Supply Chain 1,700 (198)
p2010-2012* 2010-2011 $m 2014 $m
Global Supply Chain 1,700 (198)
SG&A 3,430 (782)
R&D 3,730 (1,122)
Total 8,860 (2,102) 1,900
• Programme cost: $1.2 billion was charged in 2010, and $0.9 billion in 2011
• Benefits: Realised $1 0 billion through end of 2011 and are on track to deliverBenefits: 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
969696Strategy
*Headcount Impact: Some employees for which charges relate remain with the business at Dec 31st 2011 but will leave in 2012
Net headcount developments: 2006-2011
GlobalSupply Chain SG&A R&D AstraTech R&D
Reinvestment†Emerging Markets
Other Reinvestment
(3,000)
Wave 1 & 2-9,600 Net
(8,000)
Wave 1 & 220,500*
(13,000)
(18,000)
(23,000)
Headcount Dec 31st 2006 (66,800) Headcount Dec 31st 2011 (57,200)
9797
*Some Employees affected by the Wave 2 programme are still employed at Dec 31st 2011† Includes the acquisition of MedImmune
Strategy
Restructuring Programme: Phase 3 2012-2014
HeadcountImpact
ProgrammeCost †
Annualbenefits
Global Supply Chain 1,350 (500)
p2012-2014* 2012-2014 $m** 2014 $m
Global Supply Chain 1,350 (500)
SG&A 3,750 (800)
R&D 2,200 (800)
Total ~ 7,300 (2,100) 1,600
*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 $200m of demolition costs.]/[Cash vs non cash]
989898Strategy
Newsflow 2011e s o 0
Newsflow
Q1 2012- Q2 2013 NewsflowBRILINTA/B ili
Q1 Q2 Q3 Q4 Q1 13 Q2 13
Dapagliflozin
BRILINTA/BriliqueEU launches & ROWFurther submissions/approvals
CHMP decision
ONGLYZA/KOMBIGLYZEFurther submissions/approvals/launchesZinforoZinforoFurther submissions in ROWEU decision TC 5214Sequential read out of further Phase III dataSequential read out of further Phase III dataRENAISSANCE 4 and 5Second interim dividend 2011Ex dividend date 15th FebAstraZeneca quarterly results and AGM
26th AprFostamatinib
26th Jul 25th Oct
Initial data from OSKIRA programNKTR-118Initial data from KODIAC program
100100100Newsflow
AstraZeneca –st a e ecaHistoric performance & Shareholder returns
History
AZN: Strong financial performance 1999-2011
Cost controlOperating leverageOperating leverage
500
550CAGR
Core EPS +14%
300
350
400
450
Core Op Profit +12%
150
200
250
300
Sales +7%
0
50
100
150
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
102102History Source: AZ annual reports, implied core margins
Strong cash generation: 1999-2011
90
100($bn)
Reinvestment of 44% of Operating cash flow (excluding major 31
70
80
90( g jacquisitions)
15
50
60 111 3 13
30
40 26Div
0
10
20
2 3
23SBB 1
Capex MerckPayments
Acquisitions&
Disposals
Distributedto
Shareholders
Other 2011 NetFunds
1999Net
Funds
Pre-R&DPost Tax
Cash Flow
After TaxR&D* -10
0
103103* R&D includes internal R&D expenditures, net of tax and depreciation/amortisation,and
externalisation. Source: AZ annual reportsPlanning AssumptionsHistory
Total Shareholder return AZ vs. Peers since 2006
160%ra
te (%
)
140%
150%
AZN Total Return
al g
row
th
110%
120%
130% FTSE 100 Average Total Return
Peer Average Total Return
dex
Ann
ua
90%
100%
110%
In
80%
Note: Peers line data represents an average of the total shareholder return for (including AZ) those companies which AZ classifies as its
104104104History
peers Abbott, BMS, Eli Lilly, GSK, J&J, Merck, Novartis, Pfizer, Roche and Sanofi
Source: Morgan Stanley
AZ 10 year dividend growth vs. peers
400%e
(%)
300%
350%
grow
th ra
te
200%
250% AZN
Peer average
x An
nual
g
150%
200%GSK
Inde
x
100%
Note: Peers line data represents an average of dividend growth for (including AZ) those companies which AZ classifies as its peers Abbott,
105105105
BMS, Eli Lilly, GSK, J&J, Merck, Novartis, Pfizer, Roche and Sanofi
History Source: Bloomberg
Key Industry Growth Drivers
106
Growth Drivers
Pharmaceutical industry growth drivers
Emergence of expanded populations inpopulations innew markets Continued unmet
medical need
Increasing andageing populations
Continued scientific andtechnological advance
ageing populations
technological advance
107107107Growth Drivers
The global population is ageing, with older patients consuming more healthcare than younger patientsconsuming more healthcare than younger patients
Global population aged 65 and older millions
Ratio of healthcare costs of older patients relative to 50-64 age group
US
and older, millions patients relative to 50 64 age group65-69
70-74
977 75-79
80-100
65-69
Canada477
65 69
70-74
75-79
80-100
65-69
70 74 UK2005 2030
70-74
75-79
80-100
108108108Source: Kotlikoff & Hagist, Dec 2005
Source: World Population Prospects: The 2005 Revision http://esa.un/unpp0x 2x 4x 6x 8x 10x 12x
Growth Drivers
Worldwide, the top 10 pharmaceutical therapy t d t b $100b 2010 16areas are expected to grow by $100bn 2010-16
120,000
Emergence of expanded populations in
100,000
populations innew markets Continued unmet
medical need60,000
80,000
Increasing andageing populations20,000
40,000 2016
2011
Continued scientific andtechnological advance
ageing populations0
technological advance
109109109Growth Drivers Source: Evaluate Pharma
Emerging market GDP set for further iexpansion…
G7 countries E7 countries
Emergence of expanded populations in
20,000
25,000
) populations innew markets Continued unmet
medical need10 000
15,000
(US
$ bi
llions
Increasing andageing populations5,000
10,000
Rea
l GD
P
Continued scientific andtechnological advance
ageing populations-
technological advance
110110110Growth Drivers Source: Global insight quarterly
2010 2016-2042 ave.
GDP growth drives growth in h ti l dpharmaceuticals spend
Ph d
United States (off scale)GDP/cap 47,369 Pharma spend/cap 954
700
Pharma spendper capitaUS$, 2008
Pharma spend/cap 954
France
500
600
Germany
Japan
Spain
300
400Emerging markets
United KingdomItaly
100
200
MexicoTurkey
Brazil
00 10,000 20,000 30,000 40,000 50,000 60,000 70,000
GDP per capita US$ 2008
Russian Federation
IndiaChina
111111111Note: R2=0.8, N=63, United States outlier excluded from the regression analysis. Source: World Market Monitor; IMS.
GDP per capita US$, 2008
Growth Drivers
Emerging markets are forecast to contribute ~70% of pharma growth during 2010-201570% of pharma growth during 2010 2015
112112112Growth Drivers
Exploding emerging market ‘middle-class’
BRIC population with household income above $5,000
+21% p.a.
2014E1,864 million
2009900 million
2004270 million
113113113
1,864 million900 million270 million
Source: Economist Intelligence Unit, 2010, China NSBA, Indian NFHS, RAND, Brazil PNADGrowth Drivers
The emerging market opportunity is distributed l b f k tacross a large number of markets
Emerging market pharma sales, 2009g g p ,
Brazil, Russia, India,Mexico & Turkey ~$60bn
(~33%)Small & mid-sized EMs
~$90bn(~50%)
$30b
( 33%)
China
~$30bn(~17%)
There is a lot more than BRIC-MT
114114Source: IMSGrowth Drivers
While individual markets have ups and downs,th ‘ tf li f k t ’ id t dthe ‘portfolio of markets’ provides steady,strong growthStandard deviation of year-on-year GDP growth rates 2004-2010 (%pts)
8.6
Standard deviation of year-on-year GDP growth rates, 2004-2010 (%pts)
5.3 5.3
2.6
3.7
4.9
1 9
3.8
2.8 3.6 3.7
3.2
2.3 2 02.4
1.7 1.9 1.5 1.7
0.7
2.0 1.8
Portfolio of ~20 emerging
markets
2.0
markets
115115Source: IMS
The variation of the portfolio is lower than almost all markets individually
Growth Drivers
AstraZeneca has built a truly global emerging k t i ti d b imarkets prescription drug business
2011 Sales12011 Sales1
Asia-Pacific
$2.2bnLatin America
CEEMEA2$1.5bn$2 1bn
116116116
$2.1bn1 Actual exchange rate. 2 Central and Eastern Europe, Middle East, and Africa (including Turkey); Source: AZ
Growth Drivers
Both BRIC-MT and small and mid-sized emerging k t h t ib t d i ifi tl t thmarkets have contributed significantly to our growth
CAGRAbsolute growth2004-11 AZ emerging markets sales CAGRgrowth
$5.8bn 17%$3.9bn
2004 11 AZ emerging markets sales
$2.9bn$3.6bn 15%$1.8bn
$1.9bn$1.9bn
Small and mid-sized EMs $2.9bn
$1.1bn
$
20%$2.1bn
BRIC-MT
201120072004
$1.7bn$0.8bn
1171171171 Actual exchange rate. Source: AZ internal
201120072004
Growth Drivers
Brands dominate the market as brands are the b t f litbest proxy for qualityEmerging market sales1, 2009, Ex-manufacturer
~$50bn(~28%)
~$30bn(~17%) ~$180bn
( %)
~$90bn(~50%)
$10bn ( 5%)
Branded originals
Branded generics
Commodity generics
~$10bn (~5%)
TotalPatented originals
118118
1 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. Growth Drivers
Across emerging markets we have a highly f l tf li f b dsuccessful portfolio of brandsAZ product sales in emerging markets, 2011
$661m
$730m
$459m
$450m
$352m
$384m
$324m
$310m$310m
$298m
119119119Growth Drivers
$219m
Brand lifecycles are fundamentally different th i t bli h d k tthan in established markets
Despite expiry of key patents in most markets, product growth can be sustainedp p y y p , p gExample: Sales by country, % value growth p.a.
China – LosecBrazil – Diprivan Turkey – Pulmicort
+25% $33m $23m$15
+11%$158m+13%
$16m$7m
$15m$11m$91m$69m
201120072004201120072004 201120072004
>130 competitorsLOE1: 2001
~9 competitorsLOE1: 1999
~8 competitorsLOE1: 2001
1201201 Loss of Exclusivity. Source: AZ; IMS; EvaluatePharma.Growth Drivers
We have delivered improving profitability across i k temerging markets
AZ pre-R&D emerging markets operating margin (excluding central costs), i d d t 2011 i i t bli h d k tindexed to 2011 margins in established markets
73%
65%
Our current emerging markets margins are similar to our Europe business6 7
55%6-7 years ago
2004 2007 2011
121121121Source: AZ internalGrowth Drivers
Our strategy in emerging marketsh th l thas three elements
Emerging markets strategy
Continue to grow Extending our Broaden portfolio
A B CContinue to grow our presence in
the large BRIC-MT markets
Extending our geographicfootprint by
increasing our
Broaden portfolioto selectively
include branded generics
involvement in high-growth small
and mid-size marketsmarkets
122122122Growth Drivers
Our goal is to continue double-digit growth,ith i k t b i 25% fwith emerging markets becoming ~25% of
AZ sales by 2014AZ emerging markets revenue goal
$12bn
$8bn
$4bn
20142009$0bn
123123Growth Drivers
Q4 Financial & KeyQ4 Financial & Key Product Performance
Product Performance
Headline results Q4 2011
CERQ4 2011 ActualQ4 2010 CERgrowth
Q4 2011$m
Actualgrowth
Q4 2010$m
Revenue 8,656 8,617 0% 0%Revenue 8,656 8,617 0% 0%
Core Operating Profit 2,990 2,865 +4% +1%
Core EPS $1.61 $1.39 +16% +12%Core EPS $1.61 $1.39 +16% +12%
Restructuring ($0.36) ($0.22) MedImmune/Merck amortisation ($0.08) ($0.07) L l d Oth ($0 01) $0 05Legal and Other ($0.01) $0.05
Reported EPS $1.16 $1.15 0% -5%
125125125PerformanceFinancial Performance
Regional revenue performance Q4 2011
CERQ4 2011 CER
Global Revenue 8 656 0% +19
CER%
Q4 2011$m
CER$m
Global Revenue 8,656 0% +19
US 3,643 +5% +189
Western Europe 2,005 -15% -350
Established RoW 1 600 +3% +45Established RoW 1,600 +3% +45
Emerging Markets 1,408 +10% +135
126126126PerformanceFinancial Performance
Key brand revenue summary Q4 2011
CERQ4 2011
Crestor 1 771 +11%
CER%
Q4 2011$m
Crestor 1,771 +11%
Seroquel 1,546 +15%Seroquel IR 1 148 +12%Seroquel IR 1,148 +12%Seroquel XR 398 +27%
Nexium 1,067 -13%Nexium 1,067 13%
Symbicort 839 +13%
127127PerformanceFinancial Performance
Core margin: Q4 2011
$mCER
growth % salesDelta vsPY CER
Core Gross Margin 7,080 +1% 81.8 +90bps
Revenue 8,656 0%
Distribution (85) -1% 1.0 0bps
C SG&A (2 546) 12% 29 5 390Core SG&A (2,546) -12% 29.5 +390bps
Core Other Income 233 0% 2.7 0bps
Core Pre-R&D Profit 4,681 +10% 54.1 +480bps
Core R&D (1 692) +31% 19 5 -460bpsCore R&D (1,692) +31% 19.5 460bps
Core Operating Profit 2,990 +1% 34.5 +20 bps
128128128PerformanceFinancial Performance
Crestor
1,800
Q4 2011 Sales: $1,771m +11% CER• Crestor US TRx +4%
Statin market flat
1,400
1,600
1,800
EST ROW$465m +15%
EM ROW$158m +8%
- Statin market flat- Share of total prescriptions in Dec 12.3%- Generic atorvastatin launched end
November
800
1,000
1,200
W. EUR$305m +5%
November- Crestor TRx volume stable
• Western Europe were up 5 percent, largely on d bl di it th i F d S i
400
600
800
US$843m +12%
double-digit growth in France and Spain• Established Rest of World were up 15 percent,
with Japan accounting for half of the increaseE i M k t 8 t h
0
200
Q4 10 Q4 11
• Emerging Markets were up 8 percent, where good growth in Emerging Europe and China was partially offset by generic erosion in Brazil
• Strong brand position for patients at elevatedQ4 10 Q4 11
US W EUR
EST ROW EM ROW
• Strong brand position for patients at elevated CV risk
129129129
EST ROW EM ROW
Product Performance
Seroquel franchiseQ4 2011 Sales: $1,546m +15% CER Seroquel IR: $1,148m +12%
Seroquel XR: $398m +27%
1,200
1,400
W EUR
EST ROW$86m 19%
EM ROW$81m -6% US
• Seroquel IR were $910 million, up 18%
800
1,000W. EUR$255m +3% • Market share for Seroquel franchise was a
market leading 29.8% at end of Dec• Total prescriptions for the US antipsychotic
400
600 US$1,124m +20%
p p p ymarket were flat in the fourth quarter
ROW• Seroquel franchise sales in the Rest of World
0
200
Q4 10 Q4 11
qwere $422 million in the fourth quarter, a 3% increase
• Seroquel XR now 26% of global franchise Q4 10 Q4 11 revenue
- US: 19% of franchise- ROW: 44% of franchise
US W EUR
EST ROW EM ROW
130130130
EST ROW EM ROW
Product Performance
Seroquel XR
400
Q4 2011 Sales: $398m +27% CER US• Seroquel XR were up 31 percent to $214
300
350
W EUR
EST ROW$23m +16%
EM ROW$34m +37%
million.• US Seroquel XR TRx +8% vs a flat market
200
250W. EUR$127m +19% ROW
• Sales of Seroquel XR in ROW increased by 22%, accounting for 44% of franchise sales
100
150 US$214m +31%
outside the US• Emerging markets: Strong growth of Seroquel
XR 37%
0
50
Q4 10 Q4 11
• Further launches completed in 2011- MDD in Europe (Launched H1 in UK,
Germany, Spain)Q4 10 Q4 11
- MDD and bipolar disorder in Emerging Markets
- Xeroquel in France in BPD and US W EUR
EST ROW EM ROW
131131131
schizophrenia in NovEST ROW EM ROW
Product Performance
SymbicortUS• Symbicort TRx +9%
- Fixed combination market -2%
Q4 2011 Sales: $839m +13% CER
Fixed combination market 2%• Symbicort TRx share increased to 20.3% in
December 2011• New patient share 26%
700
800
EST ROW$123m +26%
EM ROW$115m +19%
New patient share 26%
ROW• Established ROW +26%400
500
600
W. EUR$359m +1%
$123m +26%
• Established ROW +26%- Fuelled by strong growth in Japan (up 56
percent) • Western Europe 1%
200
300
400 $
• Western Europe 1%- Data exclusivity in 10yr markets expired
in Aug 2010Complex regulatory path for generics
0
100
Q4 10 Q4 11
US$242m +26%
- Complex regulatory path for generics• Emerging Markets +19%
- China +40%
Q4 10 Q4 11
US W EUR
EST ROW EM ROW
132132132
EST ROW EM ROW
Product Performance
Nexium US• Retail volume -8 5%
Q4 2011 Sales: $1,067m, -13% CER• Retail volume -8.5%
- Generic penetration have significant impact on PPI market - decline in branded product prescription demand
1,000
1,200
EM ROW$176m +24%
- low single digit decline in average selling prices was largely due to the impact of US healthcare reform
C t ff ti ti
600
800W. EUR$145m -50%
EST ROW$132m +5%
• Cost effective promotion- No direct detailing support- Effective use of new channels
400 US$614m -8%
• Digital• Customer service representatives• Telemarketing
0
200 ROW• Western Europe -50%
- Generics are available all major European Q4 10 Q4 11 j pmarkets where France accounting for more than half of the decline
• Launched in Japan in September
Q4 10 Q4 11
US W EUR
EST ROW EM ROW
133133133
• Emerging Markets +24%- China +36%
EST ROW EM ROW
Product Performance
Iressa Q4 2011 Sales: $149m +25% CER
Strong growth in Western Europe and
120
140EM ROW$55m +38%
g g pEmerging Markets each accounting for about half of the sales increase
• Emerging Markets +38%
80
100
EST ROW
- Including a 41% increase in China- 1st line EGFR M+ approvals
• Established ROW
40
60
W EUR
EST ROW$60m +2%
Established ROW- 1st line EGFR M+ approval received in
Japan Q4
0
20
Q4 10 Q4 11
W. EUR$34m +70%
US*$0m -100%
Q4 10 Q4 11
US W EUR
EST ROW EM ROW
134134134
EST ROW EM ROW
*NDA withdrawn in the US Jan 2011Product Performance
ONGLYZA FranchiseQ4 2011 Global Alliance Revenue:
$ 71m + 122% CER80
US• TRx growth of 1ppt in Q4
60
70
80
EST ROW$3m +200%
EM ROW$5m +150%
• 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
40
50W. EUR$10m +100%
DPP4 class
EU• Komboglyze received marketing authorisation
20
30in EU in Q4
Est ROW / EM• Launched in China Q4 2011 as the first DPP4
0
10
Q4 10 Q411
US$53m +121%
Launched in China Q4 2011 as the first DPP4 inhibitor
• Further approvals and launches expectedQ4 10 Q411
US W EUR
EST ROW EM ROW
during 2012
135135135
EST ROW EM ROW
Product Performance
Investor Relations esto e at o sContacts
IR Contacts
Investor Relations Contacts
Investor Enquiries London
James Ward-Lilley [email protected] +44 207 604 8122
Karl Hård [email protected] +44 207 604 8123mob: +44 7789 654364
Nicklas Westerholm [email protected] +44 207 604 8124mob: +44 7585 404950
Investor Enquiries US
Ed Seage [email protected] +1 302 886 4065mob: +1 302 373 1361
Jörgen Winroth [email protected] +1 212 579 0506g j g @mob: +1 917 612 4043
137137IR Contacts
Cautionary Statement Regarding F d L ki St t tForward-Looking Statements
In order, among other things, to utilise the 'safe harbour' provisions of the US Private Securities Litigation Reform A t 1995 idi th f ll i ti t t t Thi t ti t i t i f d l kiAct 1995, we are providing the following cautionary statement: This presentation contains certain forward-looking statements with respect to the operations, performance and financial condition of the Group. Although we believe our expectations are based on reasonable assumptions, any forward-looking statements, by their very nature, involve risks and uncertainties and may be influenced by factors that could cause actual outcomes and results to be materially different from those predicted. The forward-looking statements reflect knowledge and information y p g gavailable at the date of preparation of this presentation and AstraZeneca undertakes no obligation to update these forward-looking statements. We identify the forward-looking statements by using the words 'anticipates', 'believes', 'expects', 'intends' and similar expressions in such statements. Important factors that could cause actual results to differ materially from those contained in forward-looking statements, certain of which are beyond our control include among other things: the loss or expiration of patents marketing exclusivity or trade marksour control, include, among other things: the loss or expiration of patents, marketing exclusivity or trade marks,or the risk of failure to obtain patent protection; the risk of substantial adverse litigation/government investigation claims and insufficient insurance coverage; exchange rate fluctuations; the risk that R&D will not yield new products that achieve commercial success; the risk that strategic alliances and acquisitions will be unsuccessful; the impact of competition, price controls and price reductions; taxation risks; the risk of substantial product li bilit l i th i t f f il b thi d ti t l t i l i th i k f f il tliability claims; the impact of any failure by third parties to supply materials or services; the risk of failure to manage a crisis; the risk of delay to new product launches; the difficulties of obtaining and maintaining regulatory approvals for products; the risk of failure to observe ongoing regulatory oversight; the risk that new products do not perform as we expect; the risk of environmental liabilities; the risks associated with conducting business in emerging markets; the risk of reputational damage; the risk of product counterfeiting; the risk of failure to g g g gsuccessfully implement planned cost reduction measures through productivity initiatives and restructuring programmes; the risk that regulatory approval processes for biosimilars could have an adverse effect onfuture commercial prospects; and the impact of increasing implementation and enforcement of more stringentanti-bribery and anti-corruption legislation. Nothing in this presentation should be construed as a profit forecast.
138138
Appendicesppe d ces
Appendices
Industry R&D spend growth
25%
30%
20%
10%
15%
5%
5%
0%
-5%1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Market Growth yoy
Appendices Source: EvaluatePharma July 2011 140
Healthcare MNC Headcount Trend1,000,000
Healthcare MNC - Headcount Trend
950,000
900,000
850,000
Healthcare MNC - Headcount Trend
800,000
750,0002006 2007 2008 2009 2010
Appendices Source: EvaluatePharma Feb 2011 & Annual reports 141