Astrazeneca Plc · LSE:AZN
Astrazeneca — Investor Presentation (June 2009)
119 slides from Astrazeneca's investor presentation, June 2009
Slide 1: General Presentation June 2009
General Presentation June 2009
Slide 2: About AstraZeneca
About AstraZeneca World leading products in 6 disease areas: cardiovascular, inflammation & respiratory; oncology; neuroscience; infection; gastro-intestinal 11 drugs with sales >$1bn in 2008 Over 65,000 employees worldwide Around 12,000 people dedicated to discovering and developing new med
Slide 3: AstraZeneca strategic priorities
AstraZeneca strategic priorities “MAKING THE MOST MEANINGFUL DIFFERENCE TO PATIENT HEALTH THROUGH GREAT MEDICINES” Reshape Change our Grow Strengthen behaviour the the business the pipeline and our business culture OUR VALUES 3
Slide 4: Key Industry Growth Drivers
AstraZeneca? Key Industry Growth Drivers
Slide 5: Pharmaceutical industry growth drivers
Pharmaceutical industry growth drivers Increasing and ageing populations Emergence of expanded populations in new markets Continued unmet medical need Continued scientific and technological advance 5
Slide 6: The global population is aging, with older patients consuming more healthcare
The global population is aging, with older patients consuming more healthcare than younger patients Ratio of healthcare costs of older patients relative to 50-64 age group Global population aged 65 65-69 and older, millions 70-74 US 75-79 977 80-100 65-69 70-74 477 Canada 75-79 80-100 65-69 70-74 20
Slide 7: Emerging Markets represent 85% of the world population
Emerging Markets represent 85% of the world population and have outpaced established markets in terms of economic growth… Developed market GDP CAGR for 2003–2007 (real) Emerging market North America and Eastern Europe Western Europe Population: 402 million Population: 740 million GDP growth: 5.9% GD
Slide 8: Emerging market GDP set for further expansion
…with Emerging market GDP set for further expansion… 25,000 G7 countries E7 countries 20,000 Real GDP (US$ billions) 15,000 10,000 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 It a hi rk ne In us ex Br m an a Ja C Tu Fr do R er M C G In 2007 2013-2038 Ave Source: Global Ins
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 $80bn by 2014
Worldwide, the top 10 pharmaceutical therapy areas are expected to grow by a further $80bn by 2014 80,000 70,000 60,000 50,000 2014 $m 40,000 2007 30,000 20,000 10,000 0 es ls gy s rs rs s es ls s ic ic ic ra ia to to iv lo in at em et vi er ila ns la o cc m ab ti- nc ct gu od da te eu Va An ba di O
Slide 11: Biologics are a strategic necessity
Biologics are a strategic necessity against a changing industry science base Key advantages of Biologics Percentage of sales of world’s top 100 products from biologics Rapidly growing markets − 11% CAGR 2007-20121 44% Longer product life cycles − Lower exposure to generic competition; high unmet
Slide 12: 1Q 2009 Results
AstraZeneca? 1Q 2009 Results ee
Slide 13: Key Achievements - 1Q09
Key Achievements - 1Q09 Core EPS increased by 20% at CER* to $1.58 Grow Grow the the Q1 sales increased by 7% at CER to $7,701m business business Crestor sales increased by 35% at CER Reshape Progress on previously announced restructuring the programmes on track business Total benefits of
Slide 14: Headline results 1Q09
Headline results 1Q09 2009 2008 Actual CER $m $m growth growth Sales 7,701 7,677 - +7% Core Operating Profit 3,362 2,765 +22% +19% Core EPS $1.58 $1.28 +24% +20% Reported EPS $1.48 $1.03 +44% +39% 14
Slide 15: Regional sales performance 1Q09
Regional sales performance 1Q09 2009 CER $m growth Sales 7,701 +7% North America 3,891 +6% US 3,624 +7% ROW Established Markets 2,834 +4% Western Europe 2,176 +2% Japan 497 +10% Other Established 161 +14% ROW Emerging Markets 976 +15% 15
Slide 16: AZ is displaying strong growth relative to the market
AZ is displaying strong growth relative to the market % growth Q1’09 MAT vs Q1’08 MAT AZ sales growth Market sales growth 45 40 35 30 28% 25% 25% 25 21% 20 16%15% 13% 14% 15 10 7% 5% 5% 5 3% 3% 3% 0 US & Latin Europe Middle Asia China Japan Canada America East & Pacific Africa Source: IMS Health, Do
Slide 17: Growth across the Business in 2009
Growth across the Business in 2009… Q1 2009 Sales Q1 2009 CER Sales Growth 50 $230m 45 40 35 +6% +4% $148m % 30 $3,891m $2,834m 25 $124m 20 15 +15% 10 46% 25% 29% $976m 5 0 North America Established RoW Emerging Markets 17
Slide 18: …and we are a top tier performer
…and we are a top tier performer IMS Ranking Latin America Asia Pacific CEEMEA Q4 2008 YTD Growth Q4 2008 YTD Growth Q4 2008 YTD Growth Market 12.9% Market 16.3% Market 10.7% 1. AstraZeneca 21.2% 1. AstraZeneca 18.1% 1. Roche 17.1% 2. EMS 14.8% 2. Bayer 16.5% 2. AstraZeneca 12.9% 3. Merck KGAA 14.5%
Slide 19: Key Brands Summary
AstraZeneca? Key Brands Summary —— EEE
Slide 20: Sales summary: 1Q09
Sales summary: 1Q09 2009 CER CER $m % $m Nexium 1,192 +2 27 Seroquel 1,125 +11 119 Crestor 969 +35 267 Arimidex 463 +14 61 Symbicort 515 +24 112 Total Key Brands 4,264 +15 586 20
Slide 21: Growth of AZ's key brands relative to the market
Growth of AZ’s key brands is strong relative to the market AZ PRODUCT GROWTH CLASS GROWTH 35 34% 30 26% 25 20 14% 15 12% 12% 10 9% 8% 6% 5 1% 0 ARIMIDEX CRESTOR NEXIUM SEROQUEL SYMBICORT -5 -2% Source: IMS Health, Dollar Growth at Constant Exchange Rate. Growth = 12 Months Ending March 2009 vs. 12 M
Slide 22: Nexium
Nexium Q1 09 Sales: $1,192m +2% US Dispensed retail tablet volume up 3.6%* Changes in IMS mail order data reporting 1,400 may be causing overstatement of ~2%* 1,200 Average realised selling prices around ROW 9% lower 1,000 $487m +12% 800 RoW 600 Emerging markets +19% 400 US Western Eur
Slide 23: Nexium US extended unit 4-week rolling TRx growth
Nexium US extended unit 4-week rolling TRx growth Source: IMS Health & JP Morgan 23
Slide 24: Seroquel
Seroquel Q1 09 Sales: $1,125m +11% US Seroquel TRx’s +3%* Market leading TRx share 31.5% 1,200 Seroquel XR: 80% of Rx gowth 1,000 ROW $325m +6% RoW 800 Sales up 6% Western Europe +19% 600 Canada –68% on generic competition US 400 $800m +14% Seroquel XR bipolar mania & bipolar depre
Slide 25: LCM update: Seroquel
LCM update Seroquel Regulatory update: Filed Approved Review Date US IR Bipolar Depression IR Bipolar Maintenance XR Schizophrenia XR Bipolar Mania XR Bipolar Depression XR Bipolar Maintenance XR Major Depressive Disorder CRL* XR Generalised Anxiety Disorder CRL* EU IR Bipolar Depression IR Bipolar
Slide 26: Seroquel XR: new indications to drive growth
Seroquel XR: new indications to drive growth… SCHIZOPHRENIA BIPOLAR MDD (DEPRESSION) High dose Medium dose Low dose Smaller market Medium market Large market Average dose 9 months1 7-8 months1 e4 Size of 4-8 months1 e4 e4 nc Patient 150mg2 400mg3 600mg3 nc nc le va population le le va va e pr e e pr
Slide 27: Crestor
Crestor Q1 09 Sales: $969m +35% US Crestor TRx’s +24%* Market TRx’s +5% 1,200 Crestor TRx share 10.3% in March 1,000 Positive net switches from other statins, ROW including generic simvastatin 800 $491m +34% Dynamic share around 15% 600 RoW Western Europe +22% 400 US Canada +26% $4
Slide 28: US statins 4-week TRx growth
US statins 4-week TRx growth rates 40% 30% Generics 20% Crestor 4-Week TRx Growth 10% 0% Market -1 0 % -2 0 % Lipitor -3 0 % Vytorin -4 0 % -5 0 % 2/4/08 3/4/08 7/4/08 3/4/09 4/4/08 8/4/08 10/4/08 2/4/09 4/4/09 5/4/08 1/4/08 6/4/08 9/4/08 11/4/08 12/4/08 1/4/09 Source: IMS NPA – Data week ending 4/1
Slide 29: US statin market TRx history since 2003
TRx Share 0% 10% 20% 30% 40% 50% 60% 09/01/03 12/01/03 03/01/04 Source: IMS Health NPA Weekly 06/01/04 09/01/04 Crestor 12/01/04 03/01/05 06/01/05 Lipitor 09/01/05 12/01/05 03/01/06 Vytorin 06/01/06 09/01/06 Zocor 12/01/06 03/01/07 06/01/07 Generics 09/01/07 12/01/07 03/01/08 06/01/08 Other Branded
Slide 30: GALAXY programme hypothesis
GALAXY programme hypothesis Lipid Profile studies STELLAR Atherosclerosis studies METEOR ASTEROID CV morbidity and mortality studies JUPITER 30
Slide 31: Crestor: STELLAR study LDL-C lowering
Crestor: STELLAR study LDL-C lowering across the dose range LDL-C: LS mean change from baseline at week 6 0 -5 -10 -15 20 -25 -30 -35 -40 -45 -50 -55 -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 *** *** *** ^^^ 10 20 40 mg mg mg P
Slide 32: Crestor – Proven to slow progression of atherosclerosis
Crestor – Proven to slow the progression of atherosclerosis Key Studies METEOR ASTEROID Label indication Approved in US Nov 2007 ‘Proven to slow the progression of atherosclerosis’ 32
Slide 33: Crestor announcement print
y-Nalatelerarexsiaatsial Print CRESTOR is now proven to slow the buildup of plaque in the arteries of adults with high cholesterol. If you have high cholesterol you may be at risk for a progressive disease called atherosclerosis, the buildup of plaque in your arteries. ‘Ask your doctor if it's time
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 Disease Patients Data expected 2011 Re-randomised N~2900 screened patients Hypercholesterolaemic Left main coronary artery: ≤50% reduc
Slide 35: JUPITER Background and Prior Work
JUPITER 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 of
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 yrs run-in 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 Tolerabili
Slide 37: JUPITER: Effects of rosuvastatin 20mg
JUPITER: Effects of rosuvastatin 20mg on LDL, HDL, TG, and hsCRP 140 60 120 50 HDL (mg/dL) LDL (mg/dL) 100 40 80 30 60 20 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 TG (mg/dL) 3 80 2 60 40 1 20 hsCRP decrease 37 percent at 12 mo
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 Rosuvastatin 142 / 8901 0.02 0.00 0 1 2 3 4 Follow-up (years) Number at Risk Rosuvastatin 8,901 8,631 8,41
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 disorders, renal disorders, or hemorrhagic stroke with treatment duration of up to 5 years show no increase in systematically monitored
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 conservatively prevent more than 250,000 heart attacks, strokes, revascularization procedures, and cardiovascular deaths in the United States alone. www.bri
Slide 42: CERTRIAD
CERTRIADTM • ~34 million Americans (both treated and untreated) have mixed dyslipidemia consisting of high 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 patien
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: Arimidex
Arimidex Q1 09 Sales: $463m +14% US Total prescriptions down 3 percent 500 In line with market decline of 2 percent 450 RoW 400 Western Europe +10% 350 ROW Emerging markets +21% 300 $244m +10% 250 200 150 100 US $219m +20% 50 0 1Q08 1Q09 US ROW 45
Slide 46: Symbicort
Symbicort Q1 09 Sales: $515m +24% US Q1 sales up 125% vs Q1’08 600 Overall market (March 09) NRx share 12.8%* 500 New start share over 20%** 400 RoW ROW Western Europe +12% 300 $416m +13% Emerging Markets +19% 200 100 US 0 $99m +125% 1Q08 1Q09 US ROW * Note: This information is an es
Slide 47: LCM update: Symbicort
LCM update Symbicort COPD approved in the US on 27 Feb 09 sNDA delivered for paediatric asthma in Jun 08. CRL received Apr 09. AZ is evaluating the CRL and will provide a response to the Agency in due course pMDI filing in UK for asthma/COPD – Sept 08 Japan anticipated approval in asthma 4Q0
Slide 48: Toprol XL
Toprol XL Sandoz and KV Pharmaceuticals have recalled or suspended shipment of generic metoprolol succinate to the US market Unclear when/if Sandoz and KV will re-enter Currently only two metoprolol succinate products on the US market: AstraZeneca’s Toprol-XL & Par’s authorised generic Astra
Slide 49: Toprol XL market share trend
Toprol XL market share trend US Toprol-XL Weekly TRx Progression (Jan '07 onwards) 1,000 900 Thousands 800 700 600 500 400 300 200 100 - May-07 May-08 May-09 Apr-07 Aug-07 Sep-07 Nov-07 Apr-08 Aug-08 Sep-08 Nov-08 Apr-09 Feb-07 Mar-07 Jul-07 Feb-08 Mar-08 Jul-08 Feb-09 Mar-09 Jan-07 Jun-07 Dec-07 Ja
Slide 50: Pulmicort
Pulmicort Q1 09 Sales: $292m -26% US Pulmicort Respules ~90% of total US 450 sales 1Q09 Pulmicort Respules -42% 400 Teva generic product had market share 350 of around 52%, reflecting a lower pull- 300 ROW through than expected 250 $119m -3% Impact on Pulmicort ex-factory sales likely to p
Slide 51: Financials
AstraZeneca? Financials .—— ET ee
Slide 52: Core margin: 1Q09
Core margin: 1Q09 Delta vs PY $m CER% % sales CER% Gross Margin 6,349 +8 82.4 +90 bps Distribution (64) +16 0.8 -10 bps R&D (980) - 12.7 +100 bps SG&A (2,236) +5 29.1 +50 bps Other Income 293 +111 3.8 +190 bps Core Operating Profit 3,362 +19 43.6 +420 bps 52
Slide 53: 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 -4000 -5000 -6000 -7000 -8000 2006-2008 headcount movements are shown on a Full Time Equivalent basis and include AZ employees and contractors 53
Slide 54: Our restructuring programme
Our restructuring programme Expanded programme now expected to cost $2.9bn $1.85bn charged in 2007-2008 − Most of remaining $1.1bn to be charged by 2010, phased roughly evenly over next two years ($72m charged in 1Q09) Expanded programme to deliver annual benefits of $2.5bn by 2013 − Around $9
Slide 55: Restructuring and synergies: Expanded scope
Restructuring and synergies: Expanded scope 2007-2008 Total Programme Cost Headcount Reduction Original Cost to Date Guidance Latest View Original $m $m $m Guidance Latest View Global Supply Chain (820) (750) (1,250) 3,300 6,150 SG&A (806) (850) (1,400) 3,600 7,450 R&D (221) (375) (300) 700 1,400 To
Slide 56: 2009 performance priorities
2009 performance priorities Drive growth of key brands and markets − Life Cycle Management − Sales and Marketing Effectiveness − Emerging Markets Progress productivity initiatives and restructuring Increased focus on cash management Continued investment in R&D 56
Slide 57: Guidance for 2009 (Core basis)
Guidance for 2009 (Core basis) Sales In line with FY08 level at CER Core EPS Growth at CER ($5.15 - $5.45) Gross Margin Slightly ahead of FY08 level (CER) SG&A Flat at CER R&D Other Income ~$900m Net Finance Expense ~$700m* Tax Rate ~ 29.5% * On the assumption that credit markets stabilise and the $
Slide 58: Currency basis for 2009 guidance
Currency basis for 2009 guidance Currency: January 2009 average rates: $1 = £0.691 $1 = EUR 0.751 $1 = SEK 8.081 $1 = JPY 90.3 Core EPS range of $5.15 to $5.45 Actual 2009 rates may differ materially from January 2009 rates upon which guidance is based 2009 currency sensitivity estimator is
Slide 59: Estimated impact of currency movements on sales and earnings
Estimated impact of currency movements on sales and earnings Estimated impact of a 10% appreciation of the respective currency against the USD Sales Core Earnings EUR 2.5% 5.2% GBP 0.3% -2.8% SEK 0.1% -3.4% JPY 0.5% 0.6% Other Currencies 2.2% 4.1% TOTAL 5.6% 3.7% 59
Slide 60: Core EPS adjustments
Core EPS adjustments 2008 2009 est. Restructuring/Synergy $0.43 ~$0.24 MedImmune amortisation $0.21 ~$0.21 Merck amortisation $0.07 ~$0.07 Impairments $0.19 60
Slide 61: Cash generation: 1Q09 vs 1Q08
Cash generation: 1Q09 vs 1Q08 2009 2008 $m $m Opening net cash/(debt) (7,174) (9,112) Net cash from operating activities 2,227 2,391 Merck - (2,630) Other capital expenditure (269) (294) Abraxane 269 - Dividends/Net share buy-back (2,097) (2,006) Other movements 191 (101) Closing net cash/(debt) (6,
Slide 62: Distribution policy
Distribution policy Dividends − Second interim dividend increased by 11% to $1.50 − Full year increase of 10% to $2.05 − To grow in line with reported earnings (pre-restructuring costs) maintaining at least 2x dividend cover Share repurchases − Reflective of stated financial priorities − No shar
Slide 63: 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 64: AstraZeneca R&D
AstraZeneca?
Slide 65: 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 65
Slide 66: AZ R&D
AZ R&D Differentiated 2008 achievements & Targeted Medicines 2 NCE submissions 8 New Life Cycle Management submissions 18 Phase II starts Ongoing productivity improvements − Faster cycle times − Leaner & cost efficient organisation Strengthen Investment in externalisation and biologics our
Slide 67: Pipeline increasing in volume and starting to mature
Pipeline increasing in volume and starting to mature 2007 – 2008 Better vertical distribution across the phases 137 144 Significant flow into Phase I 24 23 in 2007 translated into a 120 91 106 10 10 record year for 2008 25 20 Phase II entries 25 25 31 5 Clinical 5 6 18 6 Projects reached appro
Slide 68: Pipeline projects: January 2009
Pipeline projects: January 2009 New Filing Progression AZD1305 Seroquel AZD1236 Seroquel XR Addition AZD1152 Seroquel XR No Change MEDI-534 AZD8529 AZD0837 Atacand CMV vaccine AZD8075 Recentin AZD7295 Zactima*** CAT-8015 AZD8055 MEDI-528 AZD1656 Symbicort CAM-3001 AZD6918 EBV vaccine* MEDI-563 ONGLY
Slide 69: Late stage portfolio
Late stage portfolio Late stage portfolio Filed ’08 Plan to file ’09 Plan to file ’10* Plan to file ’11* LCM PDUFA date 30 July 09 ONGLYZA™ 9 Zactima 2Q Dapagliflozin ZD4054 Resubmission 2H09 Motavizumab 9 PN400 mid-09 Recentin CRC EMEA approval Iressa EU 9 Certriad™ 9 Recentin rGBM Recentin exp. mi
Slide 70: Onglyza (saxagliptin)
Onglyza (saxagliptin) DPP-4 inhibitor, partnered with Bristol-Myers Squibb NDA PDUFA date 30 Jul 09 EU MAA submitted in Jul 08 Key Efficacy Data Onglyza Phase III data presented at ADA Jun 08 show significant reductions in all key measures of glucose control: HbA1c, FPG, PPG Saxagliptin on
Slide 71: 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 Europe prevalence is in U.S. – current lower (~4.6%), but prevalence rate 6.7% increasing, especially in the south
Slide 72: The progressive nature of Type 2 Diabetes
The progressive nature of Type 2 Diabetes ultimately overwhelms medications Glycemic Control in an Illustrative Patient Potential = treatment Slope 5 p er change 0.75% First yrs. Agent 5yr s Goal* HbA1c A1c=<7 Goal** A1c=<6.5 Normal*** A1c=5% ~30 Years (*) According to the ADA; (**) according to the
Slide 73: Onglyza shows significant reductions in HbA1c, FPG, PPG
Onglyza shows significant reductions in HbA1c, FPG, PPG from baseline at Week 24 A1c Fasting Plasma Postprandial 0.6 20.0 2000 (%) Glucose Glucose 0.4 15.0 (mg/dL) (mg min/dL) 0 0.19 10.0 -646.6 0.2 6.06 -2000 5.0 0.0 0.0 -4000 -0.2 -5.0 -6000 -0.4 -0.43 -10.0 -8.67 -6868 -6896 -0.46 -8000 -0.6 -0.5
Slide 74: Patient exposures throughout Onglyza programme
Patient exposures throughout Onglyza programme Phase I and II ~110 subjects exposed to Onglyza at 20-80x the 5 mg dose for up to 6 weeks ~670 subjects exposed to Onglyza at 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 >3000 patients
Slide 75: Dapagliflozin development update
Dapagliflozin development update 9 Phase III studies ongoing, 4 fully recruited Initial Phase III data at EASD’09, further Phase IIB data at ADA’09 Phase IIb data presented at ADA 08 and EASD 08 Dapagliflozin Increases Dapagliflozin Urinary Glucose Excretion Reduces FSG 120 Dapagliflozin Dose
Slide 76: Brilinta: Top line PLATO readout in May 2009
Brilinta: Top line PLATO readout in May 2009 Approximately 18,600 patients enrolled in PLATO study Brilinta achieved a statistically significant primary efficacy endpoint versus clopidogrel in the prevention of cardiovascular (CV) events in patients with ACS Primary endpoint: CV death, MI or s
Slide 77: Prevalence of Acute Coronary Syndrome (ACS)
Prevalence of Acute Coronary Syndrome (ACS) ~3.5 million >1.4 million About every 26 seconds, an episodes of ACS hospitalisations for American will suffer reported in the ACS in the US in a coronary event2 major 7 markets 20052 (EU*, US, Japan) in 20051 About every minute, an American will die from
Slide 78: Summary of Unmet Needs in the Treatment of ACS
Summary of Unmet Needs in the Treatment of ACS At-risk prognosis – ACS is a recurring problem despite current antiplatelet therapies – Need: More consistent and effective antiplatelet therapy Speed of onset – Guidelines recommend early initiation of antiplatelet therapy to reduce period of throm
Slide 79: 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≈18,600) randomised within 24 h of index event Clopidogrel AZD6140 (Brilinta) If pretreated, no additional ld; 180-mg ld, then if naïve, standard 300-mg ld, 90-
Slide 80: Greater and more consistent IPA with AZD6140 than clopidogrel
Greater and more consistent IPA with AZD6140 than with clopidogrel Clopidogrel 75 mg qd AZD6140 100 mg bid Day 1 Day 14 Day 1 Day 14 100 100 Mean % Inhibition 80 80 Mean % Inhibition 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
Slide 81: DISPERSE2 comparable bleeding to clopidogrel
DISPERSE2 comparable bleeding to clopidogrel Minor* Overall Major 12 10.2 10.2 Total Bleeding Rate, % 10 9.2 8 6 4 2 0 AZD6140 AZD6140 Clopidogrel 90 mg bid 180 mg bid 75 mg qd Protocol-defined total bleeding rates were similar for all groups No evidence of dose-response pattern for major bleeds
Slide 82: Iressa: INTEREST
Iressa: INTEREST CHMP recommended approval of Iressa on 23 April 09 on the basis of INTEREST and IPASS Indicated in all lines of therapy for locally-advanced or metastatic NSCLC patients with activating mutations of EGFR-TK INTEREST study 1.0 Iressa docetaxel N 723 710 0.8 Events 593 (82.0%) 576
Slide 83: Iressa: IPASS
Iressa: IPASS IPASS (Iressa Pan-Asia Study) Iressa vs carboplatin/paclitaxel in 1st line adv NSCLC in a selected patient population Superior progression-free survival (PFS) for Iressa compared to doublet chemotherapy More favourable tolerability profile and superior quality of life (QoL) Pro
Slide 84: Zactima
Zactima Plan to file Zactima (100mg combination) for 2nd line NSCLC – 2Q09 Four Phase III NSCLC studies: ZODIAC (docetaxel combination) ZEAL (pemetrexed combination) Data at ASCO’09 ZEST (monotherapy vs erlotinib) ZEPHYR (monotherapy in EGFR failure) Zactima Studies Update ZODIAC showed that Z
Slide 85: Zactima ZODIAC results
Zactima ZODIAC results Primary endpoint met progression free survival benefit: Addition of Zactima to docetaxel resulted in statistically significant improvement in PFS: − Median PFS 17.3 weeks for Zactima versus 14.0 weeks for placebo − Hazard ratio 0.79 (confidence interval 0.7 – 0.9); P<0.001 O
Slide 86: 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 submissions – 2H10 Recurrent Glioblastoma − Phase III REGAL study recruiting − On track for submission – 2H10 NSCLC − New 20mg BR29 programme wit
Slide 87: 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 RECENTIN
Slide 88: ZD4054 in Phase III: Hormone refractory prostate cancer
ZD4054 in Phase III: Hormone refractory prostate cancer ENTHUSE programme actively recruiting Phase II (EPOC - Study 6) results published in European Urology – Dec 08 1.0 0.9 0.8 0.7 Proportion of patients alive Placebo 0.6 ZD4054 15 mg ZD4054 10 mg 0.5 0.4 0.3 0.2 0.1 0.0 0 50 100 150 200 250 3
Slide 89: ZD4054 Phase III Studies
ZD4054 Phase III Studies ENTHUSE M0 ENTHUSE M1 ENTHUSE M1c Study 15 Study 14 Study 33 ZD4054 + docetaxel vs ZD4054 vs placebo ZD4054 vs placebo docetaxel alone Primary Endpoint OS & PFS OS OS Number of patients ~1500 ~600 ~1000 No Metastases (M0) Metastatic (M1) Metastatic Asymptomatic or mildly sym
Slide 90: PN400: Effective chronic pain therapy with built-in GI protection
PN400: Effective chronic pain therapy with built-in GI protection Fixed dose combination of the pain reliever naproxen (an NSAID) with Nexium for chronic treatment of signs and symptoms of arthritis in patients at risk for NSAID associated ulcers Unlike standard PPIs, the esomeprazole in PN400 i
Slide 91: PN400: Significant unmet need prevails
PN400: Significant unmet need prevails OA is the most common form of arthritis, affecting 151.4 million individuals worldwide (WHO, 2004) To date, no NSAID has proven superior to another NSAID in the treatment of signs and symptoms of OA Up to 30% (25% EU5 and 29% US) of OA patients switch or
Slide 92: AZD0837: Unmet medical need
AZD0837 Unmet medical need Atrial Fibrillation and Anticoagulation Most common sustained cardiac arrhythmia (7 m diagnosed patients)* 5-fold increased risk of stroke Prevalence increasing More people >65 years old More survivors of ACS Widespread under-treatment due to challenges of anti
Slide 93: AZD0837: Opportunity
AZD0837 Opportunity Opportunity Clinical Experience Predictable relationship between >900 AF patients exposed 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 modelling,
Slide 94: AZD3480: Alzheimer's & CDS
AZD3480: Alzheimer’s & CDS Collaboration with Targacept Inc. signed in Dec 2005 Selective neuronal nicotinic receptor modulator (α4β2) Sirocco (AD) ph IIb study did not meet primary endpoint HALO (CDS) ph IIb study did not meet primary endpoint − Ph III CDS development not expected Develop
Slide 95: PARP inhibition: tumour-selective lethality
PARP inhibition: tumour-selective lethality DNA damage (SSBs) occur all the time in cells and PARP detects and repairs them PARP PARP inhibition During the DNA replication process, unrepaired SSBs are converted to DSBs Normal cell HR-deficient tumour with functional HR cell (e.g. BRCA 1/2-/-) pathwa
Slide 96: Olaparib: a novel, orally active PARP inhibitor
Olaparib: a novel, orally active PARP inhibitor Olaparib acquired as part of KuDOS acquisition for $206m in 2006 Clinical proof of concept for targeting BRCA in both breast and ovarian cancer in non-comparative studies Advanced breast cancer1: substantial single-agent activity (400mg bid) in h
Slide 97: AstraZeneca R&D: Our 2010 targets
AstraZeneca R&D: Our 2010 targets | 10 projects in Phase III/Registration 9 Achieved A biologics pipeline capable of delivering 25% of Phase III 9 Achieved 8-year median development cycle-times 9 On track 2 NMEs pa to market on average 9 On track 97
Slide 98: Our disease area strategy
Our disease area strategy… Build Maintain Exit Diabetes/Obesity Alzheimer's Hypertension Analgesia Arrhythmias Inflammatory Bowel Infection Asthma Diseases Inhalation Atherosclerosis Functional GI Disorders Translational Science Bipolar Disorder Parkinson’s Oncology Chr
Slide 99: …with implementation well underway
…with implementation well underway Enhanced capabilities in Biologicals Cross AZ – disease areas Analgesia, Oncology, Infection and Inflammation Balanced with reduction in selected small molecule areas Continued support for strategy set in 2006 with the following changes per therapeutic area: Respir
Slide 100: Biologics are a strategic necessity…
Biologics are a strategic necessity against a changing industry science base… Transforming industry pipeline Monoclonals & Vaccines are High Growth 1200 Estimated Global % of Global Market that is Product Sales ($bn) Monoclonal or Vaccine 1000 80 20% 800 15% 06-12 600 60 14% 15% CAGR 56 400 13% 50 M
Slide 101: …and MEDI completes AZ's core science base
…and MEDI completes AZ’s core science base Approach disease targets from Industry innovation driven 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 VEGF-C PlGF VEGF-
Slide 102: 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 state Deliver an average of one new biologic product per year from 2013 Drive value from CAT and Abgenix investments Bring biologi
Slide 103: Faster, Leaner, Better
Faster, Leaner, Better Quality driving cost and speed Leaner Quality $100m MedImmune synergies Continuous Improvement Clinical data outsourcing of 82 studies PERFORMANCE 5 drug campaigns supplied from Cost Speed Bangalore at 1/3rd cost More Cost Effective Completed Phase I cycle times and
Slide 104: Discovery productivity improved
Discovery productivity improved More candidates entering development More reaching 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 Molecu
Slide 105: Pipeline substantially increased
Pipeline substantially increased NMEs up 86% since 2004 LCM: 33 significant approvals since 2005 300 +138% Mix: Improved mix of NMEs v LCM 250 +100% +100% 200 NME Submissions +48% FY 2004 150 -8% FY 2008 2 NMEs submitted in 2008 100 (Motavizumab and ONGLYZA™) 50 4 potential filings in 2009
Slide 106: 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 of the total AZ NME portfolio 2% CaT in Jun
Slide 107: Biologics & Medimmune
AstraZeneca? Biologics & Medimmune —— EEE
Slide 108: 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 109: Synagis (palivizumab)
Synagis (palivizumab) Technological advancement over polyclonal 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 −marketed by MedImmune in
Slide 110: FluMist
FluMist First advance in flu vaccines in 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 54.2%
Slide 111: 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 111
Slide 112: Patents & Litigation
Patents & Litigation Note: For full litigation disclosures, please refer to the relevant sections of the Company’s 20-F filings and Quarterly Press Releases
Slide 113: Crestor US patent litigation
Crestor US patent litigation AZ and Shionogi have filed eight separate ANDA lawsuits for infringement of the Crestor ‘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 Farnan
Slide 114: Seroquel US patent litigation
Seroquel US patent litigation Judge granted AZ’s Summary Judgement of No Inequitable Conduct on 1 July 2008, ending case Trial no longer necessary Sandoz and Teva appealed. Oral hearing 6 March 2009. Awaiting decision from Appeals Court Handa, Accord and Biovail have filed Paragraph IV ANDAs
Slide 115: 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 to file”) Litigation continues with Teva, Dr Reddy’s & Sandoz Expiry o
Slide 116: Pulmicort Respules US patent litigation
Pulmicort Respules US patent litigation Teva 19 Nov 08: FDA approval for generic Pulmicort Respules. Teva launch generic at 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’s product, wi
Slide 117: 2009 Newsflow: LCM
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 AdCom XR MDD EU decision XR GAD EU decision XR bipolar maintenance EU decision IR bipolar maintenance EU decision Paediatric & adolescents US regulatory AdCom Crestor JUPITER f
Slide 118: 2009 Newsflow: NCE
2009 Newsflow: NCE Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Onglyza NDA PDUFA 30/7 MAA decision Additional Phase III data ADA Dapagliflozin Additional Phase IIb data ADA Initial Phase III data EASD Brilinta PLATO topline results 9 PLATO results presentation ESC Planned US and EU submissions Z
Slide 119: Cautionary Statement Regarding Forward-Looking Statements
Cautionary Statement Regarding Forward-Looking Statements In order to utilise the ‘Safe Harbor’ provisions of the United States Private Securities Litigation Reform Act of 1995, AstraZeneca is providing the following cautionary statement. This presentation contains forward-looking statements with re