AstraZeneca PLC · LSE:AZN
AstraZeneca — Investor Presentation (November 2009)
129 slides from AstraZeneca's investor presentation, November 2009
Slide 1: General Presentation November 2009
General Ge e a Presentation ese tat o November 2009
Slide 2: About AstraZeneca
About AstraZeneca World leading products in 6 disease areas: cardiovascular, inflammation & respiratory; oncology; neuroscience; infection; gastro-intestinal t i t ti l 11 drugs with sales >$1bn in 2008 Over O 65,000 65 000 employees l worldwide ld id Around 12,000 people dedicated to discov
Slide 3: AstraZeneca strategic priorities
AstraZeneca strategic priorities “MAKING THE MOST MEANINGFUL DIFFERENCE TO PATIENT HEALTH THROUGH GREAT MEDICINES” Reshape Change our Grow Strengthen behaviour the the business the pipeline and our business culture OUR VALUES 3
Slide 4: Key Industry Growth Drivers
Key ey Industry dust y G Growth o t Drivers es
Slide 5: Pharmaceutical industry growth drivers
Pharmaceutical industry growth drivers Increasing and ageing populations Emergence of expanded populations in new markets Continued unmet medical need Continued scientific and technological advance 5
Slide 6: The global population is ageing, with older patients consuming more healthcare
The global population is ageing, with older patients consuming more healthcare than younger patients Ratio of healthcare costs of older patients relative to 50-64 age group Global population aged 65 G 65-69 and older, millions 70-74 US 75-79 977 80-100 65-69 70-74 477 Canada 75-79 80-100 65-69 70-74
Slide 7: Emerging Markets represent 85% of the world population
Emerging Markets represent 85% of the world population and have outpaced established markets in terms of economic growth growth… Developed market GDP CAGR for 2003–2007 (real) Emerging market North America and Eastern Europe Western Europe Population: 402 million Population: 740 million GDP growth:
Slide 8: …with Emerging market GDP set for further expansion…
…with Emerging market GDP set for further expansion… p 25,000 G7 countries ti E7 countries ti 20,000 P (US$ billions) 15,000 Real GDP 10,000 5 000 5,000 - a n na a a y e a ey il ly S K o an ad pa az di si nc si ic U U Ita hi rk ne In us ex Br m an a Ja C Tu Fr do R er M C G In 2007 2013 2038 A 2013-
Slide 9: Pharmaceutical spending strongly correlated with GDP
…which is important given that pharmaceutical spending has historically been strongly correlated with GDP Pharma spend/capita 2007, $ 650 France 600 550 Japan 500 Germany 450 Sweden Spain 400 Italy United Kingdom 350 Slovenia Netherlands 300 Hungary 250 Slovakia South Korea New Zealand 200 Lithuania
Slide 10: Top pharmaceutical therapy areas expected to grow by a further $80bn by 2014
Worldwide, the top 10 pharmaceutical therapy areas are expected to grow by a further $80bn by 2014 80,000 70 000 70,000 60,000 50 000 50,000 2014 $m 40,000 2007 30,000 20,000 10,000 0 es ls y rs s rs s es ls s ic og ic ic ra ia to to iv in at em et vi er ol ila la ns cc m ab ti- nc ct gu da od rte e
Slide 11: Biologics are a strategic necessity against a changing industry science base
Biologics are a strategic necessity against a changing industry science base Key advantages of Biologics Percentage P t off sales l off world’s ld’ top t 100 products from biologics Rapidly growing markets − 11% CAGR 2007-20121 44% Longer product life cycles − Lower exposure to generic competiti
Slide 12: 3Q and 9M 2009 Results
3Q a and d99M 2009 009 Results esu ts
Slide 13: Highlights – 3Q09
Highlights – 3Q09 Core EPS increased 27% at CER* to $1.68 Grow the 3Q revenue increased 10% at CER to $8,200m business Emerging Markets revenue increased 15% at CER Progress on previously announced restructuring Reshape programmes on trackt k the business Total benefits of $2.1bn by 2010 a
Slide 14: Headline results 3Q 2009
Headline results 3Q 2009 2009 2008 Actual CER $m $m growth growth Revenue 8,200 7,775 +5% +10% Core Operating Profit 3 609 3,609 2 771 2,771 +30% +29% Core EPS $1.68 $1.32 +28% +27% Restructuring/Synergy ($0.05) ($0.06) MedImmune/Merck amortisation ($0.07) ($0.06) Intangible impairments ($0.03) ---
Slide 15: Headline results 9M 2009
Headline results 9M 2009 2009 2008 Actual CER $m $m growth growth Revenue 23,859 23,408 +2% +8% Core Operating Profit 10 577 10,577 8 273 8,273 +28% +29% Core EPS $4.90 $3.85 +27% +28% Restructuring/Synergy ($0.18) ($0.18) MedImmune/Merck amortisation ($0.20) ($0.21) Ethyol impairment --- ($0.12) In
Slide 16: Regional sales performance 9M 2009
Regional sales performance 9M 2009 2009 CER $m growth Sales 23,859 +8% North America 11,693 +10% US 10,831 +11% excluding l di T Toproll 10 064 10,064 +6% 6% RoW Established Markets 8,979 +4% Western Europe 6,715 +3% Japan 1,674 +10% Oth Established Other E t bli h d 590 +13% 13% RoW Emerging Market
Slide 17: AZ is displaying strong growth relative to the market
AZ is displaying strong growth relative to the market % growth Q2’09 MAT vs Q2’08 MAT Source: IMS Health, Dollar Growth at Constant Exchange Rate. Growth = 12 Months Ending June 2009 vs. 12 Months Ending June 2008: IMS expressly reserves all rights, including rights of copying, distribution and repl
Slide 18: We are a top tier performer in Emerging markets
We are a top tier performer in Emerging markets IMS Ranking Latin America Asia Pacific CEE/MEA Q1 2009 YTD Growth Q1 2009 YTD Growth Q1 2009 YTD Growth Market 11.3% Market 13.2% Market 10.2% 1. AstraZeneca 18.8% 1 1. Novartis 13 6% 13.6% 1 1. Abbott 26 9% 26.9% 2. EMS 11.1% 2. Wyeth 12.4% 2. Roche 2
Slide 19: Key Brands Summary
Key ey Brands a ds Su Summary ay
Slide 20: Key brand summary: 3Q 2009
Key brand summary: 3Q 2009 2009 2008 CER $m $m growth N i Nexium 1 243 1,243 1 315 1,315 -1% 1% Seroquel 1,231 1,130 +12% Crestor 1,147 922 +30% Arimidex 476 486 +2% Symbicort 562 501 +22% Total 4,659 4,354 +12% 20
Slide 21: Key brand summary: 9M 2009
Key brand summary: 9M 2009 2009 2008 CER $m $m growth N i Nexium 3 681 3,681 3 876 3,876 +1% Seroquel 3,605 3,292 +14% Crestor 3,245 2,610 +32% Arimidex 1,422 1,406 +7% Symbicort 1,628 1,490 +23% Total 13,581 12,674 +14% 21
Slide 22: Growth of AZ's key brands is strong relative to the market
Growth of AZ’s key brands is strong relative to the market % growth AZ PRODUCT GROWTH CLASS GROWTH 40 36% 35 30 26% 25 20 15% 15 12% 13% 10 9% 8% 4% 5 0% 1% 0 ARIMIDEX CRESTOR NEXIUM SEROQUEL SYMBICORT Source: IMS Health, Dollar Growth at Constant Exchange Rate. Growth = 12 Months Ending June 2009 v
Slide 23: Nexium
Nexium 3Q 2009 Sales: $1,243m -1% US 1,400 Retail volume -1.0%* 3Q 2009 average prices down -13% 1,200 1,000 RoW RoW $554m +13% Western Europe +11% 800 Emerging Markets +30% China +55% 600 US 400 $689m -12% 200 0 3Q 2008 3Q 2009 US ROW * Source: IMS Health, US NPA September 2009 23
Slide 24: Seroquel
Seroquel 3Q 2009 Sales: $1,231m +12% US 1,400 TRx’s volume up +2.4%* All growth from Seroquel XR 1,200 Market leadingg TRx share 31.3%;; RoW +12 basis points 1,000 $380m +9% Seroquel XR TRx share 3.0%; 800 +62 basis points Seroquel XR was 9.5% of TRx for total 600 Seroquel franchise US 400
Slide 25: LCM update Seroquel
LCM update q Seroquel Regulatory update: Filed Approved Review Date US IR Bipolar Bi l D Depression i IR Bipolar Maintenance XR Schizophrenia XR Bipolar Mania XR Bipolar Depression XR Bipolar Maintenance XR Major Depressive Disorder CRL* 4Q 2009 XR Generalised Anxiety Disorder CRL* EU IR Bipolar Dep
Slide 26: Seroquel XR: new indications to drive growth
Seroquel XR: new indications to drive g growth… SCHIZOPHRENIA BIPOLAR MDD (DEPRESSION) High dose Medium dose Low dose Smaller market Medium market Large market Average dose 9 months1 7-8 months1 Size of 4-8 months1 Patient mg3 mg2 mg3 400m 150m 600m population Average A treatment t t t duration d ti
Slide 27: Crestor
Crestor 3Q 2009 Sales: $1,147m +30% US 1,400 US TRx +25%* ~4 times statin market 1,200 Onlyy branded statin to g gain share 1,000 RoW Crestor TRx share 11.0% Sept $624m +34% 800 RoW Western Europe +26% 600 Australia +64% 400 US Japan J +43% 43% $523m +25% Canada +28% 200 0 JUPITER st
Slide 28: US statins 4-week TRx growth rates
4-Week TR 4 Rx Growth h -50% -40% -30% -20% -10% 0% 10% 20% 30% 40% 1/4/08 2/4/08 3/4/08 4/4/08 5/4/08 Vytorin 6/4/08 Generics Market 7/4/08 CRESTOR Source: IMS NPA – Data week ending 9 October 2009 8/4/08 9/4/08 10/4/08 1 11/4/08 1 12/4/08 1 Lipitor 1/4/09 2/4/09 3/4/09 4/4/09 5/4/09 US statins 4-w
Slide 29: US statin market TRx history since 2003
US statin market TRx history since 2003 Source: IMS Health NPA Monthly Sept 2009 29
Slide 30: GALAXY programme hypothesis
GALAXY programme hypothesis Lipid Profile studies STELLAR Atherosclerosis Ath l i studies t di METEOR ASTEROID CV morbidity and mortality studies JUPITER 30
Slide 31: Crestor: STELLAR study LDL-C lowering across the dose range
Crestor: STELLAR study LDL-C lowering g across the dose range g LDL-C: LS mean change from baseline at week 6 0 -5 5 -10 10 -15 15 20 -25 25 -30 30 -35 35 -40 40 -45 45 -50 50 -55 55 -60 60 10 20 40 mg mg mg CRESTOR 10 20 40 80 mg mg mg mg Atorvastatin *** ^^^ ^^^ 10 20 40 80 mg mg mg mg Simvastatin
Slide 32: Crestor – Proven to slow the progression of atherosclerosis
Crestor – Proven to slow the progression of atherosclerosis Key Studies METEOR ASTEROID Label indication Approved in US Nov 2007 ‘Proven ‘P to t slow l the th progression i of atherosclerosis’ 32
Slide 33: CRESTOR announcement print advertisement
y-Nalatelerarexsiaatsiall Print CRESTOR is now proven to slow the buildup of plaque in the arteries of adults with high cholesterol. The progressive buildup of plaque in your arteries is called atherosclerosis. If you have high cholesterol you may be at risk for a progressive disease i called athero
Slide 34: SATURN: IVUS study vs Lipitor
SATURN: IVUS study vs Lipitor Hypothesis: the greater impact of Crestor on LDL-C & HDL-C will translate into a greater impact on atherosclerosis Coronary Artery 1300 Data expected 2011 Disease Patients Re-randomised N~2900 screened patients Hypercholesterolaemic Left main coronary artery: ≤50% reduc
Slide 35: JUPITER Background and Prior Work
JUPITER g Background and Prior Work Current guidelines endorse statin therapy for patients with established vascular disease, diabetes, and among those with hyperlidemia. However, half of all heart attack and stroke events occur among apparently healthy men and women with average or even low levels
Slide 36: JUPITER outcomes study: design
JUPITER outcomes study: design No history of CAD Rosuvastatin 20 mg (n~7500) men ≥50 yrs Placebo women ≥60 y yrs run-in i LDL-C <130 mg/dL Placebo (n~7500) CRP ≥2.0 mg/L Visit: 1 2 3 4 Final Week: –6 –4 0 13 6-monthly 3–4 y Lead-in/ Randomisation Lipids Lipids eligibility CRP CRP Tolerability Tolera
Slide 37: JUPITER: Effects of rosuvastatin 20mg on LDL, HDL, TG, hsCRP
JUPITER: Effects of rosuvastatin 20mg on LDL,, HDL,, TG,, and hsCRP 140 60 120 50 L (mg/dL)) L (mg/dL)) 100 40 80 30 60 HDL 20 LDL 40 20 10 LDL decrease 50 percent at 12 months HDL increase 4 percent at 12 months 0 0 5 140 120 hsCRP (mg/L) 4 100 G (mg/dL)) 3 80 2 60 40 1 TG 20 hsCRP decrease 37 perc
Slide 38: JUPITER Primary Endpoint
JUPITER Primary Endpoint: MI,, Stroke,, UA/Revasc.,, CV Death Placebo 251 / 8901 HR 0.56, 95% CI 0.46-0.69 0.08 P < 0.00001 Number Needed to Treat (NNT5) = 25 - 44 % 0.06 Cumulative Incidence 0.04 0 Rosuvastatin 142 / 8901 02 0.0 0.00 0 0 1 2 3 4 Follow-up (years) Number at Risk Rosuvastatin 8,901 8
Slide 39: JUPITER efficacy results
JUPITER efficacy results Among apparently healthy men and women with elevated hsCRP but low LDL • Crestor reduced by 47 percent incident myocardial infarction, stroke, and cardiovascular death • The relative benefit observed was greater than in almost all prior statin trials • Crestor significantly
Slide 40: Safety
Safety With regard to safety, the JUPITER results show no increase in serious adverse events compared to placebo show no increase in myopathy, cancer, hepatic di d disorders, renall di disorders, d or h hemorrhagic h i stroke t k with ith treatment duration of up to 5 years show no increase in
Slide 41: Public Health Implications
Public Health Implications Application of the simple screening and treatment strategy tested in the JUPITER trial over a five-year period could conservativelyypprevent more than 250,000 , heart attacks,, strokes, revascularization procedures, and cardiovascular deaths in the United States alone. www
Slide 42: CERTRIAD
CERTRIADTM • ~34 million Americans (both treated and untreated) have mixed dyslipidaemia consisting of high LDL LDL, high TG and low HDL, many of whom are not at goal1 • Need for an effective product to comprehensively address all three lipid abnormalities • If approved, could provide an option to p
Slide 43: CERTRIAD Target Patient
CERTRIADTM Target Patient Improved Controlled statin mono patient 17 MM CERTRIAD target patient Uncontrolled Neither 29 MM Either 3.7 MM (8%) High LDL Low HDL High LDL & Low HDL High TGs (plus) Estimated Total Dyslipidemia population - Untreated 59m - Treated 46m Slide Source: Total Treated Patients
Slide 44: CERTRIAD
CERTRIADTM Target: First FDA-approved FDC combining a statin and a fibrate targeting growing mixed dyslipidemic population (driven by increasing prevalence of obesity, metabolic syndrome and diabetes)1. • Strong LDL/TG/HDL efficacy at the 10/135 mg expected starting dose • Demonstrated safety profil
Slide 45: Symbicort
Symbicort 3Q 2009 Sales: $562m +22% US 600 Overall performance NRx share 16.6%* 500 ((+270 basis p points in q quarter)) RoW New start share 26.3%** 400 $437m +11% RoW 300 Symbicort SMART approved in 96 markets 200 Western Europe +8% Emerging Markets +22% 100 US 0 $125m +95% 3Q 2008 3Q 2
Slide 46: LCM update Symbicort
LCM update y Symbicort Approved in Japan in Oct 09 for the treatment of adult asthma. AstraZeneca and Astellas Pharma will co-promote co promote Symbicort in Japan COPD approved in the US in Feb 09 sNDA delivered for paediatric asthma in Jun 08. CRL received Apr 09. Additional clinical work
Slide 47: Toprol XL
Toprol XL Sandoz and KV Pharmaceuticals have recalled or suspended shipment of generic metoprolol succinate to the US market Consequently, Consequently there were only two metoprolol succinate products on the US market during first 7 months of 2009: AstraZeneca’s Toprol-XL and Par’s authorised g
Slide 48: Toprol XL US market share trend
Toprol XL US market share trend TRx (weekly) 60% metoprolol t l l tartrate t t t 50% 40% generic metoprolol succinate 30% PAR AG 20% Toprol-XL Brand 10% Watson 0% 09 9 8 9 9 09 9 9 09 9 l-0 -0 -0 -0 -0 -0 -0 n- b- p- ug ec ay n pr ar Ju Ja Fe Ju Se D A M M A 48
Slide 49: Financials
Astrazeneca? Financials . — EC eee
Slide 50: Core margin: 3Q 2009
Core margin: 3Q 2009 CER Delta vs $m growth % sales PY CER Core Gross Margin 6,961 +14% 84.9 +270 bps Distribution (73) +4% 0.9 +10 bps Core R&D (1,049) -9% 12.8 +280 bps Core SG&A (2,373) +7% 28.9 +90 bps Core Other Income 143 -13% 1.7 -40 bps Core Operating p g Profit 3,609 , +29% 44.0 +610 bps p
Slide 51: Core margin: 9M 2009
Core margin: 9M 2009 CER Delta vs PY $m growth % sales CER Core Gross Margin 19,888 +10% 83.4 +150 bps Distribution (207) +10% 0.9 - bps Core R&D (3,064) -4% 12.9 +190 bps Core SG&A (6,825) +1% 28.6 +220 bps Core Other Income 785 +56% 3.3 +100 bps Core Operating p g Profit 10,577 , +29% 44.3 +660 bp
Slide 52: Restructuring and synergies: 2006–2008
Restructuring and synergies: 2006 – 2008 Global Emerging Supply Chain SG&A R&D AstraTech Biologics Markets 0 -1000 -2300 -2000 -3000 3000 -4000 -5000 -6000 -7000 -8000 2006-2008 headcount movements are shown on a Full Time Equivalent basis and include AZ employees and contractors 52
Slide 53: Our restructuring programme
Our restructuring programme Expanded programme now expected to cost $2.95bn $1.85bn charged in 2007-2008 − Most of remaining $1.1bn to be charged by 2010, ($374m charged September YTD 09) Expanded programme to deliver annual benefits of $2.5bn by 2013 − Around $950m benefits realised in 2008 −
Slide 54: Restructuring and synergies: Expanded scope
Restructuring and synergies: p Expanded scope p 2007 - H1 2009 Total Programme Cost Headcount Reduction Original O i i l Cost to Date Guidance Latest View Original $m $m $m Guidance Latest View Global Supply Chain (935) (750) (1,250) (1 250) 3,300 3 300 6,150 6 150 SG&A (930) (850) (1,400) 3,600 7,4
Slide 55: 2009 performance priorities
2009 performance priorities Drive growth of key brands and markets − Life Cycle Management − Sales S l and dMMarketing k ti Eff Effectiveness ti − Emerging Markets Progress productivity initiatives and restructuring g Increased focus on cash management Continued investment in R&D 55
Slide 56: Guidance for 2009 (Core basis)
Guidance for 2009 (Core basis) As updated on 29 October 2009: Sales Growth of mid- to high-single digits (CER) Gross Margin Up to 200 basis points higher than 2008 (CER) SG&A Flat at CER R&D Other Income ~ $900m Net Finance Expense ~ $700m Tax Rate ~ 29.0% Core EPS Revised Target now $6.20 to $6.40
Slide 57: Currency basis for 2009 guidance
Currency basis for 2009 guidance Currency: January 2009 average rates: $1 = £0 £0.691 691 $1 = EUR 0.751 $1 = SEK 8.081 $1 = JPY 90.3 y differ materiallyy from Januaryy 2009 rates Actual 2009 rates may upon which guidance is based 2009 currency sensitivity estimator is available 57
Slide 58: Estimated impact of currency movements on sales and earnings
Estimated impact of currency movements g on sales and earnings Estimated impact of a 10% appreciation of the respective currency against the USD Sales Core Earnings EUR 2.5% 2 5% 5.2% 5 2% GBP 0.3% -2.8% SEK 0.1% -3.4% JPY 0 % 0.5% 0 6% 0.6% Other Currencies 2.2% 4.1% TOTAL 5 6% 5.6% 3 7% 3.7% 58
Slide 59: Cash generation: 9M 2009
Cash generation: 9M 2009 2009 2008 $m $m Opening net cash/(debt) (7,174) (9,112) Net cash from operating activities 7 657 7,657 5 951 5,951 Merck - (2,630) p Other capital expenditure p ((956)) ((888)) Abraxane disposal 269 - Dividends/Net share buy-back (2,892) (3,224) Other movements (97) 154 Clos
Slide 60: Distribution policy
Distribution policy Dividends − First interim dividend of $0.59, up 7% − Policy remains to grow full dividend in line with reported earnings (pre-restructuring (pre restructuring costs) maintaining at least 2x dividend cover Share repurchases − Reflective of stated financial priorities − No shar
Slide 61: Managing the financial crisis
Managing the financial crisis Maintain credit rating Mid-term liquidity plan: Limit reliance on external sources Deliver cash and working capital targets of funding Regular challenge on the timing and need for capital expenditure Maintain solid liquidity Continue to challenge discretionary spe
Slide 62: AstraZeneca Pipeline
Astrazeneca?
Slide 63: FDA industry drug approvals 1996-2008
FDA industry drug approvals 1996-2008 Number of FDA NME/BLA approvals in 2008 is the highest in four years 63
Slide 64: Delivering on our promise
Delivering on our promise 2009 key events to date: Iressa: I A Approved d and d llaunchedh d iin EU Crestor JUPITER filed in April Brilinta Phase III PLATO trial positive p ONGLYZA™: Approved in the US and EU 3 NCE submissions: Brilinta (EU), Vimovo and Certriad Zactima Z ti fili withdra
Slide 65: Stronger pipeline
Stronger pipeline Maturing pipeline; Delivering late phase 137 144 142 120 24 23 21 Early E l portfolio tf li reached h d 91 106 10 10 10 steady state 25 20 31 29 25 25 5 5 6 18 13 13 41 34 38 23 17 17 Balanced portfolio; 31 42 45 49 46 44 Approx. 40% externalisation FY 2004 FY 2005 FY 2006 FY
Slide 66: Pipeline July 2009
Pipeline 30 July 2009 no change 11 progressions 5 new filings 12 additions MEDI-575 MEDI-573 AZD6482 AZD9164 AZD6280 AZD6088 AZD5985 AZD3043 AZD5904 AZD2551 AZD6370 AZD4769 AZD1480 AZD6244 MEDI-3250 AZD4017 AZD6714 AZD3480 AZD4694 AZD3241 AZD2423 AZD3355 AZD2066 AZD2516 AZD8075 AZD3199 AZD8529 Ataca
Slide 67: Late stage portfolio is delivering
Late stage portfolio is delivering Filed 2008 Filed 2009 On track to file 2010-11 ONGLYZA™ Zactima Dapagliflozin filing withdrawn Iressa EU Vimovo Recentin CRC Motavizumab Certriad Recentin rGBM LAIV EU Brilinta 4Q Zibotentan Ceftaroline (ex US/Canada/Japan) Therapy areas New: Collaboration agreemen
Slide 68: Diabetes: A growing global problem
Diabetes: A growing global problem Type 2 Diabetes prevalence expected to grow from 190 million to 330 million by 2030 50-70% of patients are not controlled Diabetes growing rapidly in Europe prevalence is lower U.S. – current pprevalence rate ((~4.6%), ), but increasing, g, 6.7% especially in t
Slide 69: The progressive nature of Type 2 Diabetes
The progressive nature of Type 2 Diabetes ultimatelyy overwhelms medications Glycemic Control in an Illustrative Patient Potential treatment change First Agent Goal* HbA1c c A1c=<7 Goal** A1c=<6.5 Normal*** A1c=5% ~30 Years (*) According to the ADA; (**) according to the AACE/ACE; (***) according to
Slide 70: ONGLYZA: new medication for diabetes
New medication for diabetes in a g growing g class ONGLYZA™ ONGLYZA approved in the US on 31 July 2009 2nd DPP-IV inhibitor on the US market CV event study to start in 2010 Approved in the EU in October 2009 3rd DPP-IV DPP IV inhibitor on the EU market
Slide 71: Onglyza shows significant reductions in HbA1c, FPG, PPG
Onglyza shows significant reductions in HbA1c, FPG, PPG from baseline at Week 24 A1c Fasting Plasma Glucose Postprandial Glucose 06 0.6 20 0 20.0 2000 (%) ( /dL) (mg/dL) ( min/dL) (mg i /dL) 0.4 15.0 0 0.19 10.0 -646.6 02 0.2 6.06 -2000 5.0 0.0 0.0 -4000 02 -0.2 -5.0 -6000 -0.4 -0.43 -10.0 -8.67 -68
Slide 72: Patient exposures throughout Onglyza programme
Patient exposures throughout Onglyza p g programme Phase I and II ~110 subjects exposed to Onglyza at 20-80x the 5 mg dose for up to 6 weeks ~670 670 subjects exposed to Onglyza at 2-10x 2 10x the 5 mg dose for up to 12 weeks Phase III ~1000 patients treated at 10 mg dose for up to 2 years >
Slide 73: Dapagliflozin: an exciting new approach to diabetes
Dapagliflozin: an exciting new approach to diabetes Insulin Management Glucose Management Potential first in class SGLT2 inhibitor Muscle M l Fat cells Novel insulin independent Liver Insulin Action mechanism and site of action TZDs Metformin Potential benefit in overweight and obese patients ß
Slide 74: Dapagliflozin development update
Dapagliflozin development update Dapagliflozint Potential 1st in class SGLT2 inhibitor g g – 8 fullyy recruited 11 studies ongoing Further positive Phase IIb data presented at ADA 09 2 pivotal Phase III studies reported 6 month data 1H 2009 and were presented at EASD and IDF – Oct 09 1st submission
Slide 75: Brilinta for acute coronary syndromes
Brilinta (ticagrelor) for acute coronary syndromes y Brilinta Full Phase III PLATO results presented on 30 August at ESC Submitted in the EU on 26 October US NDA is on track for submission for the fourth quarter Further data to be ppresented at AHA on 15-18 November: A late breaker on the
Slide 76: Brilinta: a promising new approach for ACS
Brilinta (ticagrelor): A promising new approach for Acute Coronary Syndromes (ACS) Brilinta • New N chemical h i l class l off P2Y12 inhibitors i hibit – Cyclo-pentyl-triazolo-pyrimidine (CPTP): not a thienopyridine or ATP analogue1 • Direct-acting Di t ti – Not a prodrug; does not require metabolic
Slide 77: Prevalence of Acute Coronary Syndrome
Prevalence of Acute Coronary Syndrome ( (ACS)) ~3 3.5 5 million >1.4 >1 4 million About everyy 26 seconds, an episodes of ACS hospitalisations for American will suffer reported in the ACS in the US in a coronary event2 major j 7 markets k t 200 2 2005 (EU*, US, Japan) in 20051 About every minute, an
Slide 78: Summary of Unmet Needs in the Treatment of ACS
Summary of Unmet Needs in the Treatment of ACS At-risk prognosis p g – ACS is a recurring problem despite current antiplatelet therapies – Need: More consistent and effective antiplatelet therapy Speed of onset – Guidelines recommend early y initiation of antiplatelet p therapy py to reduce peri
Slide 79: Greater and more consistent IPA with Brilinta than clopidogrel
Greater and more consistent IPA with Brilinta than with clopidogrel p g Clopidogrel 75 mg qd AZD6140 100 mg bid Day 1 Day 14 Day 1 Day 14 100 100 80 80 60 60 40 40 20 20 2 4 8 12 2 4 8 12 24 2 4 8 12 2 4 8 12 24 Time, h Time, h Husted SE et al. Eur Heart J 2006;27:1038–1047 79
Slide 80: Greater separation of antithrombotic response and bleeding time
Greater separation of antithrombotic response and bleeding time with Brilinta (preclinical data) Clopidogrel AZD6140 A), % A), % 100 500 100 500 Inc Inc mbosis & IPA mbosis & IPA crease in Ble crease in Ble 400 400 75 75 300 300 bition (Throm 50 50 bition (Throm eeding Time eeding Time 200 200 25 25
Slide 81: Design of the pivotal PLATO study
Design of the pivotal PLATO study UA/NSTEMI (moderate–high risk); STEMI (if primary PCI) All receiving ASA; clopidogrel-treated or naïve; (N 18 624) (N=18,624) randomised within 24 h of index event Clopidogrel AZD6140 (Brilinta) If pretreated, no additional ld; 180--mg ld, then 180 if naïve naïve, s
Slide 82: PLATO publication August 2009
PLATO publication 30 August, g , 2009 82
Slide 83: K-M estimate of time to first primary efficacy event
K-M estimate of time to first primary efficacy event (composite of CV death, MI or stroke) 13 12 Clopidogrel 11.7 nce (%) 11 10 9.8 9 Ti Ticagrelor l e inciden 8 7 6 5 Cumulativ 4 3 2 C 1 HR 0.84 (95% CI 0.77–0.92), p=0.0003 0 0 60 120 180 240 300 360 Days after randomisation No. at risk Ticagrelor
Slide 84: Primary efficacy endpoint over time
Primary efficacy endpoint over time ((Composite p of CV death, MI or stroke)) 8 8 ulative incidence (%) ulative incidence (%) 6.60 6 Clopidogrel 6 Clopidogrel 5.43 5.28 4 77 4.77 4 Ticagrelor 4 Ticagrelor 2 Cumu Cumu 2 HR 0.88 (95% CI 0.77–1.00), p=0.045 0 HR 0.80 (95% CI 0.70–0.91), p<0.001 0 0 10
Slide 85: Hierarchical testing of major efficacy endpoints
Hierarchical testing of major efficacy endpoints Ticagrelor Clopidogrel HR for All patients* (n=9 333) (n=9,291) (n=9,333) (n=9 291) (95% CI) p value† Primary objective, n (%) CV death + MI + stroke 864 (9.8) 1,014 (11.7) 0.84 (0.77 (0.77–0.92) 0.92) <0.001 0.001 Secondary objectives, n (%) Total de
Slide 86: Secondary efficacy endpoints over time
Secondary efficacy endpoints over time Myocardial infarction Cardiovascular death 7 6.9 7 Clopidogrel 6 6 5.8 e (%) Cumulative incidence (%) Clopidogrel 5.1 5 Ticagrelor 5 Cumulative incidence 4 4 4.0 Ticagrelor 3 3 2 2 1 1 C HR 0.84 (95% CI 0.75–0.95), p=0.005 HR 0.79 (95% CI 0.69–0.91), p=0.001 0
Slide 87: Time to major bleeding - primary safety event
Time to major bleeding- primary safety event 15 ce (%) Ticagrelor 11.58 11.20 10 Cl id Clopidogrel l e incidenc umulative 5 Cu HR 1.04 (95% CI 0.95–1.13), p=0.434 0 0 60 120 180 240 300 360 Days from first IP dose No. at risk Ticagrelor 9 235 9,235 7,246 7 246 6,826 6 826 6,545 6 545 5,129 5 129 3,7
Slide 88: Total major bleeding
Total major bleeding 13 NS 12 11.6 Ticagrelor 11.2 Clopidogrel p g 11 per year) 10 NS NS 8.9 8.9 9 stimated rate (% p 7.9 8 7.7 7 NS 5.8 5.8 6 5 4 K-M es 3 2 NS 1 0.3 0.3 0 PLATO major TIMI major Red cell PLATO life- Fatal g bleeding g bleeding transfusion* threatening/ bleedingg fatal bleeding Majo
Slide 89: Non-CABG and CABG-related major bleeding
Non-CABG and CABG-related major bleeding 9 NS Ticagrelor 7.9 Clopidogrel 8 74 7.4 ate (% per year) 7 NS 5.8 6 5.3 p=0.026 5 4.5 K-M estiimated ra 4 3.8 p=0.025 2.8 3 2.2 2 1 0 Non-CABG Non-CABG CABG CABG PLATO major TIMI major PLATO major TIMI major bleeding bleeding bleeding bleeding 89
Slide 90: Other findings
Other findings Ticagrelor Clopidogrel All patients (n=9 235) (n=9,235) (n=9 186) (n=9,186) p value Dyspnoea, % Any 13.8 7.8 <0.001 With discontinuation of study 0.9 0.1 <0.001 treatment Neoplasms arising during treatment, % 1.4 1.7 0.17 Any 1.2 1.3 0.69 Malignant 0.2 0.4 0.02 Benign 90
Slide 91: Holter monitoring & Bradycardia related events
Holter monitoring & Bradycardia related events Ticagrelor Clopidogrel p value Holter monitor first week (n=1,451) (n=1,415) Ventricular pauses ≥3 seconds ,% % 5.8 3.6 0.01 Ventricular pauses ≥5 seconds, % 2.0 1.2 0.10 Ticagrelor Clopidogrel p value Holter monitor at 30 days (n= 985) (n=1,006) Ventri
Slide 92: Therapeutic considerations
Therapeutic considerations Based on 1,000 patients admitted to hospital for ACS, using ticagrelor instead of clopidogrel for 12 months resulted in 14 fewer deaths 11 fewer myocardial infarctions 6–8 fewer cases with stent thrombosis No increase in bleedings requiring transfusion 9 patien
Slide 93: PLATO Conclusions
PLATO Conclusions Reversible, more intense P2Y12 receptor inhibition for one year with ith titicagrelor l iin comparison i with ith clopidogrel l id l iin a broad population with ST- and non-ST-elevation ACS p provides Reduction in MI and stent thrombosis Reduction in cardiovascular and total
Slide 94: New personalised healthcare approach (Iressa)
New personalised healthcare approach Iressa EU approval received across all lines of therapy for EGFR mutation positive NSCLC based on INTEREST, IPASS & full data review – July 09 Probabilityy of PFS 1.0 In EGFR mutation-positive patients, Iressa reduces the risk of progression by 52% vs. doublet ch
Slide 95: Zactima
Zactima Zactima Zactima (100mg in combination with chemotherapy for advanced NSCLC) submissions withdrawn in the US and EU ZEPHYR (300mg monotherapy in EGFR failures in advanced NSCLC) and ZETA (300 mg monotherapy in advanced medullary thyroid cancer) data expected late 2009 or early 2010
Slide 96: Recentin
Recentin CRC − Go into Phase III as achieved efficacy trigger – Feb 08 − HORIZON Phase III recruitment completed on schedule (end 08) − On track for ssubmissions bmissions – 2H10 Recurrent Glioblastoma − Phase III REGAL study recruiting − On track for submission – 2H10 NSCLC − New 20mg BR29 pr
Slide 97: Recentin development programme
Recentin development programme Key Trials: First Patient Dosed to Data Available CRC H2H with bevacizumab HORIZON III : 1st line CRC PhII/III FF+bevacizumab vs FF+RECENTIN Submission HORIZON II : 1st line CRC PhIII FOLFOX or XELOX +/- +/ RECENTIN rGBM REGAL : rGBM PhIII lomustine+/- Submission RECEN
Slide 98: Zibotentan in Phase III: Hormone refractory prostate cancer
Zibotentan in Phase III: Hormone refractoryy prostate p cancer ENTHUSE M1 study fully recruited, M0 & M1c actively recruiting Phase II (EPOC - Study 6) results published in European Urology – Dec 08 1.0 0.9 0.8 0.7 atients alive Placebo 0.6 Zibotentan 15 mg Zibotentan 10 mg 0.5 Proportion of pa
Slide 99: Zibotentan Phase III Studies
Zibotentan Phase III Studies ENTHUSE M0 ENTHUSE M1 ENTHUSE M1c Study y 15 Study 14 Study 33 Zibotentan vs placebo Zibotentan vs placebo Zibotentan + docetaxel vs Primary Endpoint OS & PFS OS docetaxel alone Number of p patients ~1500 ~600 OS ~1000 No Metastases (M0) Metastatic (M1) Metastatic Asympt
Slide 100: Vimovo: Proven OA pain relief with built-in GI protection
Proven OA pain relief with built-in GI p protection Vimovo POZEN submitted NDA in June; FDA acceptance announced 31 August ’09 09 AstraZeneca submitted MAA in October Previously called PN400; a fixed dose combination of enteric-coated enteric coated (EC) naproxen and immediate release esomepra
Slide 101: Ceftaroline: A late-stage, next generation cephalosporin antibiotic
Ceftaroline: A late-stage, next generation cephalosporin p p antibiotic Ceftaroline Collaboration with Forest Laboratories announced 12 August 2009 AstraZeneca to co-develop and commercialize in all markets outside US/Canada/Japan Phase III investigational cephalosporin antibiotic in developme
Slide 102: AZD0837: Unmet medical need
AZD0837 Unmet medical need Atrial Fibrillation and Anticoagulation y Most common sustained cardiac arrhythmia ((7 m diagnosed g patients)* ) 5-fold increased risk of stroke Prevalence increasing More p people p >65 yyears old More survivors of ACS Widespread under-treatment due to challe
Slide 103: AZD0837: Opportunity
AZD0837 Opportunity pp y Opportunity Clinical Experience Predictable relationship between 900 AF patients exposed >900 dose and blood levels Longest exposure to date of 16 Low to moderate PK variability months Dose selected via biomarkers and Incidence of liver ALT increases extensive mo
Slide 104: Science behind PARP inhibitors
The science behind PARP inhibitors leads to two potential therapeutic mechanisms Without PARP inhibition With PARP inhibition Cells with HR deficiency (e.g. Normal cells with drug- Cells with HR deficiency and Normal cells cancer cells with BRCA mutation) induced PARP inhibition drug-induced PARP in
Slide 105: Olaparib: a novel, orally active PARP inhibitor
Olaparib: a novel, orally active PARP inhibitor Olaparib acquired as part of KuDOS acquisition for $206m in 2006 Clinical proof of concept for targeting BRCA in both breast and ovarian cancer in non-comparative studies Advanced breast cancer1: substantial single-agent activity (400mg bid) in h
Slide 106: AstraZeneca R&D: Our 2010 targets
AstraZeneca R&D: Our 2010 targets | 10 projects in Phase III/Registration 9 Achieved A biologics pipeline capable of delivering 25% of Phase III 9 Achieved 8-year median development cycle-times 9 On track 2 NMEs pa to market on average 9 On track 106
Slide 107: Our disease area strategy…
Our disease area strategy… Build Maintain Exit Diabetes/Obesity Alzheimer's Hypertension Analgesia Arrhythmias Inflammatory Bowel Infection Asthma Diseases Inhalation Atherosclerosis Functional GI Disorders Translational Science Bipolar Disorder Parkinson’s Oncology Chr
Slide 108: …with implementation well underway
…with implementation well underway Enhanced capabilities in Biologicals Cross AZ – disease areas Analgesia, g , Oncology, gy, Infection and Inflammation Balanced with reduction in selected small molecule areas Continued support for strategy set in 2006 with the following changes per therapeutic area
Slide 109: Biologics are a strategic necessity against a changing industry science base
Biologics are a strategic necessity against a changing g g industryy science base… Transforming industry pipeline Monoclonals & Vaccines are High Growth 1200 Estimated Global % of Global Market that is Product Sales ($bn) Monoclonal or Vaccine 1000 80 20% 800 15% 06 12 06-12 600 60 14% 15% CAGR 56 4
Slide 110: …and MEDI completes AZ's core science base
…and MEDI completes AZ’s core science base Approach disease targets from IIndustry d t innovation i ti driven di b by 3 all sides core approaches MOA Avastin and AZD2171 Avastin Ligand Sequestration Avastin (Genentech/Roche: Launched March ‘04) x AstraZeneca VEGF-A x VEGF-A VEGF-B VEGF-C VEGF-D VE
Slide 111: Strategic Priorities for Biologics
Strategic Priorities for Biologics Increased productivity targets 6 INDs (8 CDs) per annum At least 3 new projects in pivotal trials by 2010; 1 BLA/year steady t d state t t Deliver on average one new biologic product per year from 2013 0 3 Drive value from CAT and Abgenix investments Brin
Slide 112: Faster, Leaner, Better
Faster, Leaner, Better Qualityy driving g cost and speed p Leaner Quality $100m MedImmune synergies Continuous Improvement Clinical data outsourcing of 82 studies PERFORMANCE 5 drugg campaigns p g supplied pp from C Cost Speed Bangalore at 1/3 cost rd More Cost Effective Completed Phase I
Slide 113: Discovery productivity improved
Discovery productivity improved More candidates entering g development p More reachingg first 39 time in man (FTIM) 36 27 33 8 24 30 3 8 21 27 24 18 1 21 15 18 15 12 28 21 12 22 24 9 16 9 15 17 12 14 6 10 9 6 8 6 8 3 3 0 0 2002 2003 2004 2005 2006 2007 2008 2002 2003 2004 2005 2006 2007 2008 Small M
Slide 114: Pipeline substantially increased
Pipeline substantially increased NMEs up 86% % since 2004 LCM: 33 significant approvals since 2005 300 +138% Mix: Improved p mix of NMEs v LCM 250 +100% +100% 200 NME Submissions +48% FY 2004 150 -8% 8% FY 2008 2 NMEs submitted in 2008 (Motavizumab and ONGLYZA™) 100 50 3 filings g in 2009
Slide 115: Strategically positioned for long-term success
Strategically positioned for long-term success Focused Disease Area Strategy − Major review in 2006 − Refined in 2007 − Albireo GI spin-off Feb 2008 Jan 2005 Jan 2009 Biologics Creation of a significant biologics portfolio 25% - approx. one quarter t off the th total t t l AZ NME portfolio tf
Slide 116: Biologics & MedImmune
Biologics o og cs & MedImmune ed u e
Slide 117: MedImmune today
MedImmune today Responsible for all global biologics-related activities Combines the resources and expertise of CAT and AZ’s other biologics projects under MedImmune’s leadership Provides new strategic, product development opportunities for AZ Operationally independent, strategically aligned
Slide 118: Synagis (palivizumab)
Synagis (palivizumab) Technological T h l i l advancement d t over polyclonal l l l antibody – Respigam First MAb approved for an infectious disease Standard of care in prevention of serious RSV lower respiratory tract infections in high risk infants Major Launches: US 98, EU 00, JP 02 −mark
Slide 119: FluMist
FluMist First advance in flu vaccines in 60+ 60 years − Highly effective, needle free seasonal flu vaccine − For healthy people 2-49 years of age Proven efficacy against matched and mismatched strains Multiple studies versus “the shot” have demonstrated favorable efficacy − CP111: 52.5% and 54
Slide 120: Novel influenza A (H1N1) vaccine
Novel influenza A (H1N1) vaccine Order of $453m placed from US HHS for pandemic flu vaccine US FDA approved MedImmune’s H1N1 vaccine on 15 September Enough bulk vaccine to fill all orders placed has been manufactured $152m booked in 3Q09; most of the remaining pandemic flu revenue to be book
Slide 121: Motavizumab & FluMist (LAIV)
Motavizumab & FluMist (LAIV) Motavizumab − US BLA for premature and CLD – Submitted 1Q08 − Received CRL from FDA in 4Q08 − Expect to resubmit in 2H09 Live Attenuated Influenza Vaccine (LAIV) − MAA submission accepted for review by EMEA – 4Q08 121
Slide 122: Patents & Litigation
Patents ate ts & Litigation t gat o Note: For full litigation disclosures, please refer to the relevant sections of p y 20-F filings the Company’s g and Quarterly y Press Releases
Slide 123: Crestor US patent litigation
Crestor US patent litigation AZ and Shionogi have filed eight separate ANDA lawsuits for infringement of the Crestor ‘314 314 compound patent −All dosage forms (5, 10, 20 & 40mg) were challenged AZ not aware of which filer is “first to file” −District Court for the District of Delaware −Judge Fa
Slide 124: Seroquel US patent litigation
Seroquel US patent litigation Judge granted AZ’s AZ s Summary Judgement of No Inequitable Conduct on 1 July 2008, ending case Trial no longer necessary Sandoz S d and d Teva T appealed. l d IIn S September t b 2009 th the Court of Appeals for the Federal Circuit affirmed the District Court’s d
Slide 125: Nexium US patent litigation
Nexium US patent litigation Settlement with Ranbaxy announced 15 April 2008 Ranbaxy granted license to launch 27 May 2014 Patent litigation against Ranbaxy has been dismissed Ranbaxy holds 180 days exclusivity (“first ( first to file”) file ) Litigation continues with Teva, Dr Reddy’s, San
Slide 126: Pulmicort Respules US patent litigation
Pulmicort Respules US patent litigation Teva 19 Nov 08: FDA approval for generic Pulmicort Respules. Respules Teva launch generic at risk. risk Citizen’s Petition denied 26 Nov 08: AZ settles with Teva Exclusive license beginning 15 Dec 09 AZ will receive significant royalty on sales of Teva
Slide 127: 2H 2009 newsflow: LCM
2H 2009 newsflow: LCM Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Seroquel XR GAD US regulatory AdCom XR MDD US regulatory response XR MDD EU decision CHMP XR GAD EU d decision i i XR bipolar maintenance EU decision IR bipolar maintenance EU decision Paeds/adolescents US sNDA decision schiz adol
Slide 128: 2H 2009 newsflow: NCE
2H 2009 newsflow: NCE Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec ONGLYZA ONGLYZA™ NDA PDUFA EMEA approval Dapagliflozin Phase III data (study 14) EASD Phase III data (study 13) IDF Certriad NDA filing Brilinta PLATO topline results PLATO results presentation ESC 30/8 Planned US and EU filings E
Slide 129: Cautionary Statement Regarding Forward-Looking Statements
Cautionary Statement Regarding Forward-Lookingg Statements In order to utilise the ‘Safe Harbor’ provisions of the United States Private Securities Litigation g Reform Act of 1995,, AstraZeneca is pproviding g the following cautionary statement. This presentation contains forward-looking statements