AstraZeneca PLC · LSE:AZN
AstraZeneca — FY2009 Earnings Presentation
123 slides from AstraZeneca's earnings presentation, February 2010
Slide 1: General Presentation
General Presentation February 2010
Slide 2: 2009 Highlights
2009 Highlights Strong financial performance Product launches Revenue +7% CER Iressa in EU Core EPS +23% CER ONGLYZA Supply chain excellence New external collaborations Restored US Toprol-XL supply NKTR-118, -119 (Nektar) H1N1 pandemic vaccine TC-5214 (Targacept) Ceftarolin
Slide 3: Strategy Update & Planning Assumptions 2010+
Strategy Update & Planning Assumptions 2010+
Slide 4: AstraZeneca: 2009
AstraZeneca: 2009 AstraZeneca in 1999 AstraZeneca in 2009 47,000 employees 63,000 employees Healthcare revenue: $15bn Healthcare revenue: $32.8bn Only 6% of sales from Emerging markets = 13% of sales emerging markets 10 products >$1bn annual sales 2 products >$1bn annual sales >50%
Slide 5: Sales evolution: 1999-2009
Sales evolution: 1999-2009 ($bn) 35 32.8 CAGR 30 +8% 25 13.6 20 15.0 15 11.0 8.3 6.8 10 5 6.7 0 1999 Facing Expiry Base New 2009 55% Facing Patent Expiry^ ^ Within 5 years 5
Slide 6: AZN: Strong financial performance
AZN: Strong financial performance 1999-2009 CAGR 500 450 Core EPS +16% 400 Core Op Profit +15% 350 300 250 Sales +8% 200 150 100 50 0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Source: AZ annual reports, implied core margins 6
Slide 7: Our vision
Our vision AstraZeneca is Focused Integrated Innovation-driven Global 7
Slide 8: Our vision
Our vision AstraZeneca is a focused, integrated, innovation-driven, global, Rx-based biopharmaceutical business Research based Pharma is an attractive business for the long-term Sector can grow at least in line with real GDP growth long term The sector‟s best players will earn attractive ret
Slide 9: Strategic priorities
Strategic priorities “MAKING THE MOST MEANINGFUL DIFFERENCE TO PATIENT HEALTH THROUGH GREAT MEDICINES” Change Strengthen Grow Reshape our behaviour the pipeline the business the business and our culture MANAGE FOR LONG-TERM SHAREHOLDER VALUE OUR VALUES 9
Slide 10: Strategic priorities
Strategic priorities “MAKING THE MOST MEANINGFUL DIFFERENCE TO PATIENT HEALTH THROUGH GREAT MEDICINES” Pipeline Business Business Culture & Growth Shape Behaviour Increase output Growth of current Implement asset Innovation Avg. 2 NMEs/yr products strategy & LEAN Drive productivity Succes
Slide 11: Key planning assumptions
Key planning assumptions Pharma sector can grow at least in line with real GDP, which will grow over the planning horizon Downward pressures from government interventions in the marketplace continue, including various proposals in US healthcare reform No further “step-change” in evolution of t
Slide 12: Grow the Business
Grow the Business Strategic Initiatives Grow market share of key brands that retain exclusivity: Planning assumptions Crestor 2010-2014 Seroquel XR Symbicort Revenue in the range of $28 to $34bn per annum over the period Successfully commercialise recent launches and the next wave. Risk ad
Slide 13: Reshape the Business
Reshape the Business Strategic Initiatives Maintain gross margin >80% Complete asset strategy & API outsourcing Drive LEAN Sigma Improve Sales & Marketing effectiveness and efficiency Planning assumptions 2010-2014 New channels and approaches Technology investment Core pre-R&D operating
Slide 14: Cash generation and investment
Cash generation and investment Business focus on cash flow generation Achieving revenue and Core pre-R&D margins in planning range Delivering restructuring programmes Tight management of working capital, tax & interest Reinvest 40 to 50% of after-tax pre-R&D cash flow to drive future growt
Slide 15: Strong cash generation: 1999-2009
Strong cash generation: 1999-2009 ($bn) 100 90 Reinvestment of 45% of 80 Operating cash flow 24.4 (excluding major acquisitions) 70 60 12.8 50 86.5 14.5 40 30 2.7 16.2 Div 20 10 18.1 2.2 SBB 0.5 0.5 0 -10 1999 Pre-R&D After Tax Capex Acquisitions Merck Distributed Other 2009 Net Post Tax R&D* & Paym
Slide 16: Invest in value-creating innovation
Invest in value-creating innovation Strategic Initiatives Reprioritisation of target disease areas* Planning assumptions 2010-2014 Reorganisation and process improvement in development 2 NMEs per annum on average Site consolidation* Material efficiency savings in R&D Partial mitigation f
Slide 17: Restructuring Programme 2007-2009
Restructuring Programme 2007-2009 Programme Cost Headcount Impact 2007-2009 $m 2007-2009 Global Supply Chain (1,003) 4,250 SG&A (1,216) 6,750 R&D (288) 1,600 Total (2,506) 12,600 Annual benefits Benefits to date Latest view 2009 $m 2010 $m Total 1,600 2,400 17
Slide 18: Restructuring and synergies: 2006-2009
Restructuring and synergies: 2006-2009 Global Emerging Supply Chain SG&A R&D AstraTech Biologics Markets -1,000 -4,600 -3,000 -5,000 -7,000 -9,000 -11,000 -13,000 2006-2009 headcount movements are shown on a Full Time Equivalent basis and include AZ employees and contractors 18
Slide 19: Restructuring Programme 2010-2014
Restructuring Programme 2010-2014 Programme Cost Headcount Impact 2010-2014 $m 2010-2014 Global Supply Chain (340) 2,240 SG&A (600) 4,540 R&D (1,060) 3,620* Total (2,000) 10,400 Annual Benefits Latest view 2014 $m Total 1,900 * Of which 3500 related to new programme: balance from previously announce
Slide 20: Guidance for 2010 (Core basis)
Guidance for 2010 (Core basis) Revenue Up to a mid single-digit decline at CER Core Pre-R&D Margin Near top of mid-term planning range Net Finance Expense ~$550m Tax Rate ~29% Core EPS Range $5.75 to $6.15* *Based on Jan 2010 avg Fx rates 20
Slide 21: Shareholder distribution policy
Shareholder distribution policy Full year 2009 dividend $2.30 (up 12 percent) Progressive dividend policy Maintain or grow dividend each year 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
Slide 22: Currency basis for 2010 guidance
Currency basis for 2010 guidance Currency basis for 2010 guidance Currency: January 2010 average rates: $1 = £ 0.698 $1 = EUR 0.618 $1 = SEK 7.113 $1 = JPY 91.4 Actual 2010 rates may differ materially from January 2010 rates upon which guidance is based 2010 currency sensitivity esti
Slide 23: Estimated impact of currency movements on sales and earnings
Estimated impact of currency movements on sales and earnings Estimated impact of a 10% appreciation of the respective currency against the USD 23
Slide 24: Key Industry Growth Drivers
AstraZeneca? Key Industry Growth Drivers
Slide 25: Pharmaceutical industry growth drivers
Pharmaceutical industry growth drivers Increasing and ageing populations Emergence of expanded populations in new markets Continued unmet medical need Continued scientific and technological advance 25
Slide 26: The global population is ageing, with older patients consuming more healthcare
The global population is ageing, with older patients consuming more healthcare than younger patients Ratio of healthcare costs of older patients relative to 50-64 age group Global population aged 65 65-69 and older, millions 70-74 US 75-79 977 80-100 65-69 70-74 477 Canada 75-79 80-100 65-69 70-74 2
Slide 27: Emerging Markets represent 85% of world population
Emerging Markets represent 85% of the world population and have outpaced established markets in terms of economic growth… 27
Slide 28: Emerging market GDP set for further expansion
…with Emerging market GDP set for further expansion… 25,000 G7 countries E7 countries 20,000 Real GDP (US$ billions) 15,000 10,000 5,000 - na da a n y sia ce a il ey ly US UK ico an pa di az i Ita ss an na i rk ne In Ch ex Br m Ja Ru Tu Fr Ca do er M G In 2007 2013-2038 Ave Source: Global Insight Qu
Slide 29: Pharmaceutical spending 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 30: 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. Novartis 13.6% 1. Abbott 26.9% 2. EMS 11.1% 2. Wyeth 12.4% 2. Roche 21.9% 3. Bayer 11
Slide 31: Top pharmaceutical therapy areas expected to grow by $80bn 2007-14
Worldwide, the top 10 pharmaceutical therapy areas are expected to grow by $80bn 2007-14 80,000 70,000 60,000 50,000 2014 $m 40,000 2007 30,000 20,000 10,000 0 s s y s rs s rs ls s ics al ve og ic ne ic ia to to at vir et em i er ol ila i la ns cc m ab ti- nc ct gu od da rte eu Va An ba di O re ch p
Slide 32: 2009 Annual Results
AstraZeneca? 2009 Annual Results
Slide 33: Headline results: FY2009
Headline results: FY2009 2009 2008 Actual CER $m $m growth growth Revenue 32,804 31,601 +4% +7% Core Operating Profit 13,621 10,958 +24% +23% Net Finance Expense (736) (463) Core EPS $6.32 $5.10 +24% +23% Dividend $2.30 $2.05 +12% Net Funds/(Debt) 535 (7,174) Reported EPS $5.19 $4.20 +24% +23% 33
Slide 34: Regional revenue performance: FY2009
Regional revenue performance: FY2009 2009 CER $m growth Revenue 32,804 +7% North America 15,981 +9% US 14,778 +9% excluding Toprol XL/H1N1 13,425 +2% RoW Established Markets 12,471 +4% Western Europe 9,277 +3% Japan 2,341 +7% Other Established 853 +12% RoW Emerging Markets 4,352 +12% 34
Slide 35: AZ is displaying strong growth relative to the market
AZ is displaying strong growth relative to the market % growth Q3‟09 MAT vs Q3‟08 MAT AZ sales growth 40 Market sales growth 35 31% 30 27% 25% 25 20 16% 15 14% 13% 12% 12% 11% 10 5% 5 4% 4% 4% 2% 0 US & Canada Latin Europe Middle East Asia Pacific China Japan America & Africa Source: IMS Health, Dol
Slide 36: Key Brand revenue summary: FY2009
Key Brand revenue summary: FY2009 2009 CER CER $m % $m Nexium 4,959 -1 (73) Seroquel 4,866 +12 521 Crestor 4,502 +29 1,048 Arimidex 1,921 +7 129 Symbicort 2,294 +23 456 Total key brands 18,542 +12 2,081 36
Slide 37: Nexium
Nexium FY 09 Sales: $4,959m (-1%) 6,000 US 5,000 Average realised selling prices -8% in ROW 2009 4,000 $2,124m +9% RoW 3,000 Emerging markets +15% Western Europe +7% 2,000 US $2,835m -9% 1,000 0 FY 08 FY 09 US ROW 37
Slide 38: Seroquel
Seroquel FY 09 Sales: $4,866m (+12% CER) 6,000 US 5,000 Market leading TRx* share (31.3%) & ROW NRx share (31.3%) $1,450m +8% 4,000 Seroquel XR accounts for 11% of franchise in Dec 09 3,000 RoW US Seroquel XR accounts for 24% of 2,000 $3,416m +13% Seroquel franchise in Dec 09 Emerging ma
Slide 39: 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* 1H 2009 EU IR Bipolar Depression IR
Slide 40: 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 Size of 4-8 months1 Patient 400mg3 150mg2 600mg3 population Average treatment duration 1 IMS Longitudinal p
Slide 41: Crestor
Crestor FY 09 Sales: $4,502m (+29% CER) 5,000 US 4,500 Crestor TRx share 11.3% Dec 09 4,000 3,500 ROW RoW 3,000 $2,402m +33% Western Europe +24% 2,500 Canada +27% 2,000 Japan +58% Emerging markets +32% 1,500 US $2,100m +25% 1,000 Jupiter FDA response due Q1 2009 500 0 FY 08 FY 09 US
Slide 42: 4-Week TRx Growth
4 week MAT Growth in the US YTD Dec. EST „09 total market growth 5.3% (Generic 19.5% / Branded -9.0% / CRESTOR 22.8%) YTD Dec. ‟08 total market growth 5.2% (Generic 26.9% / Branded -10.1% / CRESTOR 12.3%) 50% 40% CRESTOR 30% 4-Week TRx Growth 20% Generics 10% 0% Market -10% Lipitor -20% -30% Vytorin
Slide 43: GALAXY programme hypothesis
GALAXY programme hypothesis Lipid Profile studies STELLAR Atherosclerosis studies METEOR ASTEROID CV morbidity and mortality studies JUPITER 43
Slide 44: Crestor: STELLAR study LDL-C lowering across the dose range
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 45: 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 to slow the progression of atherosclerosis‟ 45
Slide 46: Announcement Print
Announcement Print (Bad news for plaque.) CRESTOR is now proven to slow the buildup of plaque in the arteries of adults with ee ) ® ® high cholesterol. ‘The pregabalin af pain yursrtaiaeiclnd atrccrale It you have high cholesterol you may be at risk for a progressive disease ‘called atherosclerosis,
Slide 47: 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 48: 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 49: 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 50: JUPITER: Effects of rosuvastatin 20mg on LDL, HDL, TG, and hsCRP
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 TG (mg/dL) 100 3 80 2 60 40 1 20 hsCRP decrease 37 percent at 12 mo
Slide 51: 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 52: 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 53: 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 54: 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 55: Symbicort
Symbicort FY 09 Sales: $2,294m (+23% CER) 2,500 US 2,000 Share of fixed combination products 17.4% in Dec 2009 (+5.8 percentage points) 1,500 ROW $1,806m +13% RoW 1,000 Western Europe +11% Emerging Markets +21% 500 US $488m +91% Japanese launch Jan 13th 2009 0 FY 08 FY 09 US ROW * Note:
Slide 56: LCM update Symbicort
LCM update Symbicort Approved in Japan in Oct 09 for the treatment of adult asthma. AstraZeneca and Astellas Pharma will co-promote Symbicort in Japan Launched Jan 13th 2010 COPD approved in the US in Feb 09 sNDA delivered for paediatric asthma in Jun 08. CRL received Apr 09. Additional cl
Slide 57: Arimidex
Arimidex FY 09 Sales: $1,921m (+7% CER) 2,500 2,000 Maturing class ROW 1,500 $1,043m +0% Patients reaching end of 5 year treatment term 1,000 Patent expiry US 500 June 2010 US $878m +16% August 2010 EU 0 FY 08 FY 09 US ROW 57
Slide 58: Toprol XL
Toprol XL Sandoz and KV Pharmaceuticals have recalled or suspended shipment of generic metoprolol succinate to the US market 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 generic Uncl
Slide 59: Toprol XL US market share trend
Toprol XL US market share trend TRx (weekly) 60% metoprolol tartrate 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 59
Slide 60: AstraZeneca
AstraZeneca?
Slide 61: A changing landscape....
A changing landscape.... Challenges Pricing and market access Tougher regulatory environment Generic threat and patent expiry Opportunities Breakthroughs in science Ageing patient populations Unmet medical needs 61
Slide 62: ....requires continuous R&D evolution
....requires continuous R&D evolution Our R&D strategy Enhance key capabilities Focused Disease Area strategy Effective and flexible R&D operating model 62
Slide 63: Investing in capabilities to drive productivity
Investing in capabilities to drive productivity Top priorities for investment Personalised healthcare / translational medicine Impact Predictive sciences / medicine Probability of success Clinical trial design and interpretation Cycle time Innovative scientists and culture Cost / launch Integrated p
Slide 64: With a focus on prioritised disease areas
With a focus on prioritised disease areas Criteria Attractiveness rating Prevalence: Population with disease High attractiveness Future willingness to pay: Increased or sustained Based on level of unmet need, high investment competitive intensity (e.g., order to market, generics), pricing, and Mediu
Slide 65: Strengthened R&D operating model
Strengthened R&D operating model Discovery and early development Late-stage Development Biologics focused Innovative Medicines Units Internal and Global external Medicines Market opportunities Development Small molecule focused Innovative Medicines Units Strategic Governance Portfolio Investment Boa
Slide 66: Successful delivery of new products
Successful delivery of new products... 6 key regulatory approvals in the last 12 months Global ONGLYZA launched in EU and US; approved in 36 countries US H1N1 vaccine in the US ($453m government contract) Seroquel XR MDD approved Symbicort COPD approved EU Iressa launched in EU Asia Symbicort launch
Slide 67: Supported by additional significant submissions
...supported by 6 additional significant submissions... Filed in US and EU Jupiter data filed in US and EU Certriad Filed in US Filed in US and EU ONGLYZA metformin once daily combination - filed in US Faslodex 500mg filed in US, EU and Japan 67
Slide 68: Filling our late stage pipeline with new opportunities
...and filling our late stage pipeline with new opportunities Cancer: Olaparib, a novel PARP inhibitor, to start Phase III in mid 2010 in gBRCA-deficient breast cancer Infection: Ceftaroline, a next generation cephalosporin, positive efficacy and safety profile shown in Phase III trials Novexel acqu
Slide 69: Discovery productivity improved
Discovery productivity improved More candidates More reaching first entering development time in man (FTIM) 69
Slide 70: Pipeline growth reaching steady state
Pipeline growth reaching steady state 144 146 137 14 23 11 24 120 91 106 10 10 25 34 25 20 31 25 5 5 6 18 13 13 41 44 34 17 17 23 31 45 42 46 43 49 FY2004 FY2005 FY2006 FY2007 FY2008 FY2009 Pre-clinical Phase I Phase II Phase III/Reg LCM 70
Slide 71: Late stage portfolio is maturing
Late stage portfolio is maturing Filed 2009 Potential Filings 2010 Filing Opportunities 2011-14 Vimovo Recentin CRC Zibotentan CAZ104 Certriad Recentin rGBM Olaparib CytoFab Brilinta Dapagliflozin Dapa / Metformin FDC AZD6244 ONGLYZA / Metformin Axanum Ceftaroline TC-5214 AZD6765 FDC NKTR-118 AZD115
Slide 72: Certriad
Certriad • ~34 million Americans (both treated and untreated) have mixed dyslipidaemia 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 patient
Slide 73: Certriad target population
Certriad target population Certriad In the US, 29m dyslipidaemic patients continue to have lipid abnormalities despite therapy 12m of those patients have mixed dysplipdaemia Patient Type Market Opportunity On therapy, but uncontrolled LDL-C Predominant CERTRIAD • High LDL • Lipid Triad • 8.7MM •
Slide 74: Certriad
Certriad 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 profile
Slide 75: 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 prevalence rate (~4.6%), but increasing, 6.7% especially in the south
Slide 76: Progressive nature of Type 2 Diabetes
The progressive nature of Type 2 Diabetes ultimately overwhelms medications Glycemic Control in an Illustrative Patient Potential treatment change First Agent Goal* HbA1c A1c=<7 Goal** A1c=<6.5 Normal*** A1c=5% ~30 Years (*) According to the ADA; (**) according to the AACE/ACE; (***) according to th
Slide 77: New medication for diabetes in a growing class: ONGLYZA
New medication for diabetes in a growing 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 inhibitor on the EU market FDC of Onglyza & metformin submitted in US Dec
Slide 78: 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 0.6 20.0 2000 (%) (mg/dL) (mg min/dL) 0.4 15.0 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 79: 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 80: Dapagliflozin clinical studies
Dapagliflozin: Phase 3 Data Presented in T2D treatment 2009 was the Start of the Story Diet and exercise paradigm Oral anti-diabetic Oral anti-diabetic Monotherapy medication plus Insulin alone medication(s) insulin H2H vs. SU Add-on insulin +/- OAD Dapagliflozin clinical studies Monotherapy
Slide 81: Brilinta (ticagrelor) for acute coronary syndromes
Brilinta (ticagrelor) for acute coronary syndromes 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 presented at AHA on 15-18 November: STEMI ACS cohort in PLATO ONS
Slide 82: 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 83: 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) 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 84: 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 11 Cumulative incidence (%) 10 9.8 9 Ticagrelor 8 7 6 5 4 3 2 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 9,333 8,62
Slide 85: Primary efficacy endpoint over time
Primary efficacy endpoint over time (Composite of CV death, MI or stroke) 8 8 Cumulative incidence (%) Cumulative incidence (%) 6.60 6 Clopidogrel 6 Clopidogrel 5.43 5.28 4.77 4 Ticagrelor 4 Ticagrelor 2 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 20 30 31 90 1
Slide 86: Hierarchical testing of major efficacy endpoints
Hierarchical testing of major efficacy endpoints Ticagrelor Clopidogrel HR for All patients* (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 (0.77–0.92) <0.001 Secondary objectives, n (%) Total death + MI + stroke 901 (10.2) 1,065 (12
Slide 87: Secondary efficacy endpoints over time
Secondary efficacy endpoints over time Myocardial infarction Cardiovascular death 7 6.9 7 Clopidogrel 6 6 5.8 Cumulative incidence (%) Cumulative incidence (%) Clopidogrel 5.1 5 Ticagrelor 5 4 4 4.0 Ticagrelor 3 3 2 2 1 1 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 0 0
Slide 88: Total major bleeding
Total major bleeding 13 NS 12 11.6 Ticagrelor 11.2 Clopidogrel 11 K-M estimated rate (% per year) 10 NS NS 8.9 8.9 9 7.9 8 7.7 7 NS 5.8 5.8 6 5 4 3 2 NS 1 0.3 0.3 0 PLATO major TIMI major Red cell PLATO life- Fatal bleeding bleeding transfusion* threatening/ bleeding fatal bleeding Major bleeding an
Slide 89: Non-CABG and CABG-related major bleeding
Non-CABG and CABG-related major bleeding 9 NS Ticagrelor 7.9 Clopidogrel 8 7.4 K-M estimated rate (% per year) 7 NS 5.8 6 5.3 p=0.026 5 4.5 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 90
Slide 90: Other findings
Other findings Ticagrelor Clopidogrel All patients (n=9,235) (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 91
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) Ventricu
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 ticagrelor in comparison with clopidogrel in a broad population with ST- and non-ST-elevation ACS provides Reduction in MI and stent thrombosis Reduction in cardiovascular and total mortality No change in
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 Probability of PFS 1.0 In EGFR mutation-positive patients, Iressa reduces the risk of progression by 52% vs. doublet che
Slide 95: Zactima
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Slide 96: Recentin
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Slide 97: Recentin development programme represents a significant opportunity
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Slide 98: Zibotentan in Phase III: Hormone refractory prostate cancer
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Slide 99: New prostate cancer treatment in Phase III development
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Slide 100: Vimovo: Proven OA pain relief with built-in Gastroprotection
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Slide 101: Anti-Infective portfolio covering a broad spectrum
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Slide 102: Ceftaroline: A late-stage, next generation cephalosporin antibiotic
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Slide 103: The Problems of cSSSI and CABP
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Slide 104: Robust clinical efficacy in phase 3 trials
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Slide 105: Science behind PARP inhibitors: two potential therapeutic mechanisms
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Slide 106: Olaparib – Phase III in advanced breast cancer starting mid 2010
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Slide 107: NKTR-118 Addresses a significant medical need
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Slide 108: NKTR-118 increases frequency of spontaneous bowel motions
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Slide 109: TC-5214: new late stage opportunity in major depression
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Slide 110: TC-5214 Phase 2b Results
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Slide 111: Synagis (palivizumab)
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Slide 112: FluMist & LAIV
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Slide 113: Novel influenza A (H1N1) vaccine
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Slide 114: Motavizumab
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Slide 115: Patent Litigation
Patent Litigation Note: For full litigation disclosures, please refer to the relevant sections of the Company’s 20-F filings and Quarterly Press Releases
Slide 116: Crestor US patent litigation
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Slide 117: Nexium US patent litigation
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Slide 118: Pulmicort Respules US patent litigation
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Slide 119: Seroquel US patent litigation
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Slide 120: Newsflow 2010
AstraZeneca? Newsflow 2010
Slide 121: 2010 newsflow
2010 newsflow Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Seroquel XR GAD US regulatory response XR MDD EU decision XR GAD EU decision CHMP Crestor JUPITER FDA Response US Patent litigation trial 22nd Feb Certriad FDA Response on NDA Vimovo FDA Response on NDA Motavizumab FDA Response on CRL res
Slide 122: 2010 newsflow continued
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Slide 123: 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